{"meta":{"ingestedAt":"2026-11-11T06:15:35.397Z","trialCount":2085,"conditionCount":55,"drugCount":24,"locationCount":300,"ctgovRecruitingSampled":2085,"enrichmentLlama":0,"enrichmentRules":2085,"source":"ClinicalTrials.gov API v2"},"conditions":[{"slug":"breast-cancer","name":"Breast cancer","query":"breast cancer","group":"Cancer","blurb":"Trials testing new drugs, antibody therapies, surgery timing, and radiation approaches.","searchIntent":"breast cancer clinical trials","intro":"Breast cancer studies on ClinicalTrials.gov cover early-stage, metastatic, hormone-receptor, HER2, and triple-negative disease. This hub lists recruiting records from the official US registry, rewritten in plain English, with the NCT number on every card. A listing here is not a match, a referral, or a claim that a treatment works."},{"slug":"prostate-cancer","name":"Prostate cancer","query":"prostate cancer","group":"Cancer","blurb":"Hormone therapy, PSMA-targeted drugs, and active-surveillance studies.","searchIntent":"prostate cancer clinical trials","intro":"Prostate cancer trials range from active surveillance and focal therapy to hormone-sensitive and castration-resistant disease. Many records mention PSMA imaging or androgen-pathway drugs. Read the official NCT page for stage, prior treatment, and PSA rules before you contact a site."},{"slug":"lung-cancer","name":"Lung cancer","query":"lung cancer","group":"Cancer","blurb":"Immunotherapy, targeted pills for EGFR/ALK, and early-detection studies.","searchIntent":"lung cancer clinical trials","intro":"Lung cancer hubs on this site include non-small cell and small cell records pulled from ClinicalTrials.gov. Targeted-therapy studies often require a documented mutation; immunotherapy studies often require PD-L1 or prior-treatment details. Those rules live on the NCT record, not in our rewrite."},{"slug":"colorectal-cancer","name":"Colorectal cancer","query":"colorectal cancer","group":"Cancer","blurb":"Immunotherapy, targeted drugs, and surgery-timing studies for colon and rectal cancer.","searchIntent":"colorectal cancer clinical trials","intro":"Colon and rectal cancer trials may study chemotherapy around surgery, targeted drugs for RAS or BRAF changes, immunotherapy for MSI-high tumors, or liver-directed approaches. Confirm the exact tumor type and molecular tests the protocol requires on ClinicalTrials.gov."},{"slug":"pancreatic-cancer","name":"Pancreatic cancer","query":"pancreatic cancer","group":"Cancer","blurb":"Chemotherapy combinations, KRAS-targeted drugs, and earlier-detection studies.","searchIntent":"pancreatic cancer clinical trials","intro":"Pancreatic cancer records often combine chemotherapy backbones with newer targeted or immune approaches, or they study earlier detection in high-risk families. Eligibility is usually strict about stage, bilirubin, and prior regimens. Use the NCT link as the source of truth."},{"slug":"melanoma","name":"Melanoma","query":"melanoma","group":"Cancer","blurb":"Checkpoint drugs, TIL therapy, and adjuvant studies after surgery.","searchIntent":"melanoma clinical trials","intro":"Melanoma trials include adjuvant studies after surgery, metastatic immunotherapy combinations, and cellular therapies such as TIL. BRAF status and prior checkpoint drugs often decide whether a record applies. We do not interpret pathology reports."},{"slug":"ovarian-cancer","name":"Ovarian cancer","query":"ovarian cancer","group":"Cancer","blurb":"PARP inhibitors, antibody-drug conjugates, and maintenance after platinum therapy.","searchIntent":"ovarian cancer clinical trials","intro":"Ovarian, fallopian-tube, and primary peritoneal studies are often grouped on the registry. Platinum sensitivity, BRCA or HRD status, and number of prior lines are typical inclusion filters. Those details are copied from the NCT eligibility block."},{"slug":"glioblastoma","name":"Glioblastoma","query":"glioblastoma","group":"Cancer","blurb":"Surgery, radiation, temozolomide combinations, and experimental brain-tumor drugs.","searchIntent":"glioblastoma clinical trials","intro":"Glioblastoma (GBM) studies may enroll at first diagnosis, at recurrence, or around radiation. MGMT, IDH, and steroid dose often appear in eligibility. A rewrite on this page never replaces the neurosurgery or oncology team who must confirm whether a site is open."},{"slug":"leukemia","name":"Leukemia","query":"leukemia","group":"Cancer","blurb":"Targeted pills, antibodies, CAR-T, and transplant-related studies for blood cancers.","searchIntent":"leukemia clinical trials","intro":"Leukemia on ClinicalTrials.gov includes AML, ALL, CLL, CML, and related subtypes. Each protocol is usually specific to one lineage and prior therapy. Check the condition line and the inclusion block on the NCT record before assuming a listing applies to you."},{"slug":"lymphoma","name":"Lymphoma","query":"lymphoma","group":"Cancer","blurb":"CAR-T, bispecific antibodies, and chemotherapy-sparing studies for Hodgkin and NHL.","searchIntent":"lymphoma clinical trials","intro":"Lymphoma trials split by Hodgkin versus non-Hodgkin, and further by B-cell or T-cell subtype. CAR-T and bispecific antibody studies usually require a measured disease status and a washout from prior treatment. We list recruiting registry cards only."},{"slug":"multiple-myeloma","name":"Multiple myeloma","query":"multiple myeloma","group":"Cancer","blurb":"Bispecifics, CAR-T, and maintenance studies after transplant or relapsed disease.","searchIntent":"multiple myeloma clinical trials","intro":"Myeloma studies often specify newly diagnosed versus relapsed/refractory disease, and whether a patient has had a transplant or BCMA therapy. Lab thresholds for blood counts and kidney function are common. Confirm them on the official record."},{"slug":"kidney-cancer","name":"Kidney cancer","query":"renal cell carcinoma","group":"Cancer","blurb":"Immunotherapy, VEGF drugs, and adjuvant studies after kidney surgery.","searchIntent":"kidney cancer clinical trials","intro":"Most kidney-cancer records on the registry are renal cell carcinoma (RCC). They may study adjuvant therapy after nephrectomy or combinations for metastatic disease. Histology (clear cell vs other) is often required. We do not guess histology from a rewrite."},{"slug":"bladder-cancer","name":"Bladder cancer","query":"bladder cancer","group":"Cancer","blurb":"BCG, immunotherapy, antibody-drug conjugates, and bladder-sparing approaches.","searchIntent":"bladder cancer clinical trials","intro":"Bladder cancer trials distinguish non-muscle-invasive disease (often BCG-related) from muscle-invasive and metastatic urothelial cancer. Antibody-drug conjugates and checkpoint drugs appear frequently. Stage and prior BCG failure rules live on the NCT page."},{"slug":"liver-cancer","name":"Liver cancer","query":"hepatocellular carcinoma","group":"Cancer","blurb":"Immunotherapy, TACE combinations, and transplant-window studies for HCC.","searchIntent":"liver cancer clinical trials","intro":"Hepatocellular carcinoma (HCC) studies often require a Child-Pugh class, viral-hepatitis status, and prior local therapy such as TACE. Some records enroll other primary liver tumors. Read the condition field; we do not merge different liver cancers into one recommendation."},{"slug":"stomach-cancer","name":"Stomach cancer","query":"gastric cancer","group":"Cancer","blurb":"HER2, Claudin 18.2, immunotherapy, and perioperative chemotherapy studies.","searchIntent":"stomach cancer clinical trials","intro":"Gastric and gastroesophageal junction trials often require HER2, PD-L1, or Claudin 18.2 testing. Perioperative versus metastatic protocols are different records. This hub is a snapshot of recruiting ClinicalTrials.gov cards, not a treatment ranking."},{"slug":"cervical-cancer","name":"Cervical cancer","query":"cervical cancer","group":"Cancer","blurb":"Immunotherapy, HPV-related studies, and treatments for recurrent disease.","searchIntent":"cervical cancer clinical trials","intro":"Cervical cancer studies may enroll newly diagnosed locally advanced disease or recurrent/metastatic disease after platinum. HPV status and prior radiation often appear in eligibility. Confirm with the study team using the official NCT contact."},{"slug":"endometrial-cancer","name":"Endometrial cancer","query":"endometrial cancer","group":"Cancer","blurb":"Immunotherapy, targeted drugs, and studies after surgery or at recurrence.","searchIntent":"endometrial cancer clinical trials","intro":"Endometrial (uterine) cancer trials frequently split by mismatch-repair status (dMMR vs pMMR) and by prior lines of therapy. We rewrite the registry summary; we do not interpret your pathology report or recommend a protocol."},{"slug":"head-and-neck-cancer","name":"Head and neck cancer","query":"head and neck cancer","group":"Cancer","blurb":"HPV-related oropharynx studies, immunotherapy, and radiation combinations.","searchIntent":"head and neck cancer clinical trials","intro":"Head and neck squamous cell carcinoma (HNSCC) records may specify oral cavity, oropharynx, larynx, or unknown primary, and HPV/p16 status. Prior radiation and feeding-tube status can appear in exclusions. Use the NCT record for site-specific rules."},{"slug":"alzheimer","name":"Alzheimer's disease","query":"Alzheimer disease","group":"Brain and nerve","blurb":"Amyloid and tau drugs, lifestyle trials, and studies for caregivers and prevention.","searchIntent":"alzheimer's clinical trials","intro":"Alzheimer's studies range from prevention in people with biomarkers but few symptoms, to treatment of mild cognitive impairment and dementia. Many drug trials require amyloid PET or CSF tests and a study partner. Those requirements are on the ClinicalTrials.gov record."},{"slug":"parkinson","name":"Parkinson's disease","query":"Parkinson disease","group":"Brain and nerve","blurb":"Dopamine therapies, device implants, and trials aimed at slowing progression.","searchIntent":"parkinson's clinical trials","intro":"Parkinson's trials may study motor symptoms, wearing-off, dyskinesia, cognition, or investigational disease-modifying drugs. Hoehn and Yahr stage, levodopa dose, and device history (DBS) often decide eligibility. We do not score how well a drug works."},{"slug":"multiple-sclerosis","name":"Multiple sclerosis","query":"multiple sclerosis","group":"Brain and nerve","blurb":"B-cell drugs, remyelination experiments, and progressive-MS trials.","searchIntent":"multiple sclerosis clinical trials","intro":"MS records usually specify relapsing, secondary progressive, or primary progressive disease. EDSS scores, recent relapses, and prior B-cell therapy appear often. Progressive-MS studies are not interchangeable with relapsing protocols — check the NCT condition line."},{"slug":"migraine","name":"Migraine","query":"migraine","group":"Brain and nerve","blurb":"CGRP blockers, devices, and prevention vs. rescue studies.","searchIntent":"migraine clinical trials","intro":"Migraine trials split into prevention (fewer monthly days) versus acute treatment (stopping an attack). CGRP antibodies, gepants, devices, and behavioral programs all appear on the registry. Monthly migraine-day counts are typical inclusion numbers — they come from the protocol, not from us."},{"slug":"als","name":"ALS","query":"amyotrophic lateral sclerosis","group":"Brain and nerve","blurb":"Drug, gene, and device studies for amyotrophic lateral sclerosis.","searchIntent":"ALS clinical trials","intro":"ALS (amyotrophic lateral sclerosis) studies often require a recent diagnosis window, a breathing (FVC) threshold, and a stable riluzole or edaravone regimen. Genetic subtypes such as SOD1 have their own records. This hub is a registry snapshot, not an ALS clinic."},{"slug":"epilepsy","name":"Epilepsy","query":"epilepsy","group":"Brain and nerve","blurb":"Add-on medicines, devices, and surgery-related studies for seizures.","searchIntent":"epilepsy clinical trials","intro":"Epilepsy trials may enroll focal or generalized seizures, treatment-resistant disease, or specific syndromes. Seizure counts and current anti-seizure medicines are usually logged in a diary. We rewrite what the registry says; we do not adjust anyone's medication."},{"slug":"stroke","name":"Stroke","query":"stroke","group":"Brain and nerve","blurb":"Recovery, prevention after a first stroke, and acute hospital studies.","searchIntent":"stroke clinical trials","intro":"Stroke records include acute hospital treatment, secondary prevention, and rehabilitation. Time-from-onset windows for acute studies can be hours, not days. Rehab studies may require a specific deficit or time since the event. Confirm timing on the NCT page."},{"slug":"type-2-diabetes","name":"Type 2 diabetes","query":"type 2 diabetes","group":"Metabolic","blurb":"GLP-1 and SGLT2 drugs, insulin combinations, and diet or device studies.","searchIntent":"type 2 diabetes clinical trials","intro":"Type 2 diabetes trials often set an A1C range, BMI band, and a list of allowed background medicines. Some records study heart, kidney, or liver outcomes rather than glucose alone. Nothing here is a prescription or a substitute for your clinician."},{"slug":"obesity","name":"Obesity","query":"obesity","group":"Metabolic","blurb":"Weight-loss medicines (including GLP-1s), surgery, and behavioral programs.","searchIntent":"obesity clinical trials","intro":"Obesity studies may test medicines, devices, surgery, or behavioral programs. BMI cutoffs and obesity-related conditions (sleep apnea, diabetes) often appear in inclusion text. Brand names on a card are registry intervention names, not ads or endorsements."},{"slug":"fatty-liver","name":"Fatty liver disease (MASH)","query":"nonalcoholic steatohepatitis","group":"Metabolic","blurb":"MASH/NASH drug trials, fibrosis imaging studies, and metabolic combinations.","searchIntent":"NASH clinical trials","intro":"Metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) trials often require a recent biopsy or a specific fibrosis stage on imaging. Alcohol use, other liver diseases, and diabetes control are common filters. We keep the registry wording for those rules."},{"slug":"chronic-kidney-disease","name":"Chronic kidney disease","query":"chronic kidney disease","group":"Metabolic","blurb":"SGLT2 drugs, anemia treatments, and dialysis-sparing studies.","searchIntent":"chronic kidney disease clinical trials","intro":"CKD studies usually define an eGFR window and sometimes albuminuria. Dialysis and transplant protocols are separate from earlier-stage records. Anemia, mineral-bone, and heart-risk studies also appear. Lab ranges on the NCT page decide eligibility, not this rewrite."},{"slug":"pcos","name":"PCOS","query":"polycystic ovary syndrome","group":"Metabolic","blurb":"Metabolic, fertility, and symptom studies for polycystic ovary syndrome.","searchIntent":"PCOS clinical trials","intro":"PCOS trials may focus on ovulation, insulin resistance, weight, or androgen symptoms. Diagnostic criteria (Rotterdam or similar) and pregnancy plans often appear in eligibility. This is not fertility advice; it is a readable slice of public registry cards."},{"slug":"depression","name":"Depression","query":"major depressive disorder","group":"Mental health","blurb":"Fast-acting medicines, psychedelics, TMS, and add-on treatments after an antidepressant.","searchIntent":"depression clinical trials","intro":"Major depressive disorder studies may test add-on pills, ketamine/esketamine, psychedelic-assisted protocols, TMS, or digital programs. Many require a documented inadequate response to prior antidepressants and a stable psychotherapy plan. Safety exclusions are strict — read them on the NCT record."},{"slug":"ptsd","name":"PTSD","query":"post traumatic stress disorder","group":"Mental health","blurb":"Therapy plus medicine studies, including some psychedelic-assisted protocols.","searchIntent":"PTSD clinical trials","intro":"PTSD trials combine psychotherapy, medicines, devices, or (in some records) psychedelic-assisted therapy under a protocol. Trauma type, CAPS scores, and current medicines often appear in inclusion text. We do not provide crisis care; use local emergency services if you are in danger."},{"slug":"bipolar-disorder","name":"Bipolar disorder","query":"bipolar disorder","group":"Mental health","blurb":"Maintenance, depression, and mania studies with medicines or therapy.","searchIntent":"bipolar disorder clinical trials","intro":"Bipolar studies usually specify type I or II, current mood state (depression, mania, mixed, or euthymic maintenance), and a mood-stabilizer baseline. We rewrite registry language only. This site is not a substitute for psychiatric care."},{"slug":"schizophrenia","name":"Schizophrenia","query":"schizophrenia","group":"Mental health","blurb":"Antipsychotic, negative-symptom, and cognition studies.","searchIntent":"schizophrenia clinical trials","intro":"Schizophrenia trials may enroll first-episode, treatment-resistant, or stable outpatients. PANSS scores, prior clozapine, and substance-use rules are common. Caregivers or study partners are sometimes required. Eligibility is decided by the site, not by this page."},{"slug":"anxiety","name":"Anxiety disorders","query":"generalized anxiety disorder","group":"Mental health","blurb":"GAD and related anxiety studies with medicines, therapy, or digital tools.","searchIntent":"anxiety clinical trials","intro":"This hub starts from generalized anxiety disorder records and may include related anxiety listings the registry tagged in the same harvest. Protocols differ by diagnosis (GAD, panic, social anxiety). Match the NCT condition field to the diagnosis a clinician has given."},{"slug":"adhd","name":"ADHD","query":"attention deficit hyperactivity disorder","group":"Mental health","blurb":"Medicine, digital, and adult-ADHD studies from the public registry.","searchIntent":"ADHD clinical trials","intro":"ADHD trials enroll children, adolescents, or adults depending on the protocol. Stimulant history, rating-scale scores, and school or work measures often appear. Pediatric studies have extra consent rules. We do not diagnose ADHD or recommend a stimulant."},{"slug":"rheumatoid-arthritis","name":"Rheumatoid arthritis","query":"rheumatoid arthritis","group":"Immune and joints","blurb":"Biologics, JAK inhibitors, and tapering studies for people already on treatment.","searchIntent":"rheumatoid arthritis clinical trials","intro":"RA studies often require a swollen/tender joint count, a rheumatoid factor or CCP test, and a list of prior DMARDs. Some records test tapering after remission. Infection-risk exclusions are common. This is registry text, not rheumatology advice."},{"slug":"lupus","name":"Lupus","query":"systemic lupus erythematosus","group":"Immune and joints","blurb":"B-cell and interferon-pathway drugs for SLE and lupus nephritis.","searchIntent":"lupus clinical trials","intro":"SLE and lupus nephritis are often separate NCT records. SLEDAI scores, steroid dose, and kidney-biopsy class appear frequently. Pregnancy and live-vaccine rules are typical exclusions. Confirm lab cutoffs on ClinicalTrials.gov."},{"slug":"psoriasis","name":"Psoriasis","query":"psoriasis","group":"Immune and joints","blurb":"Injectable biologics, oral TYK2 drugs, and combination skin studies.","searchIntent":"psoriasis clinical trials","intro":"Plaque psoriasis trials usually set a BSA and PASI minimum. Psoriatic arthritis may be a related but separate record. Phototherapy and prior biologic washouts are common. We do not rate which biologic is best."},{"slug":"crohns-disease","name":"Crohn's disease","query":"Crohn disease","group":"Immune and joints","blurb":"Gut-targeted biologics, oral drugs, and diet studies.","searchIntent":"crohn's disease clinical trials","intro":"Crohn's trials specify location (ileum, colon), prior biologics, and sometimes fistula disease. Endoscopy or calprotectin thresholds often appear. Diet studies are not interchangeable with drug studies. Read the intervention type on the NCT card."},{"slug":"ulcerative-colitis","name":"Ulcerative colitis","query":"ulcerative colitis","group":"Immune and joints","blurb":"Gut-targeted biologics, oral small molecules, and combination induction studies.","searchIntent":"ulcerative colitis clinical trials","intro":"UC studies usually require a Mayo or similar endoscopy score and a defined extent of colitis. Hospitalized acute severe UC is a different protocol from outpatient moderate disease. We list recruiting registry cards without ranking treatments."},{"slug":"osteoarthritis","name":"Osteoarthritis","query":"osteoarthritis","group":"Immune and joints","blurb":"Knee and hip pain studies, injections, devices, and exercise programs.","searchIntent":"osteoarthritis clinical trials","intro":"Osteoarthritis trials often focus on knee or hip pain, with X-ray grade and pain-score cutoffs. Injections, devices, medicines, and exercise programs all appear. A listed site is not a guarantee of insurance coverage or of benefit."},{"slug":"atopic-dermatitis","name":"Eczema (atopic dermatitis)","query":"atopic dermatitis","group":"Immune and joints","blurb":"Biologics, JAK inhibitors, and topical studies for eczema.","searchIntent":"eczema clinical trials","intro":"Atopic dermatitis studies set EASI or IGA score floors and often a body-surface minimum. Age bands (pediatric vs adult) matter. Prior dupilumab or JAK inhibitor use can include or exclude you. Those rules are on the official record."},{"slug":"endometriosis","name":"Endometriosis","query":"endometriosis","group":"Women's health","blurb":"Hormone-sparing drugs, pain studies, and fertility-preserving approaches.","searchIntent":"endometriosis clinical trials","intro":"Endometriosis trials may require surgical diagnosis or imaging plus symptoms. Pain scores, hormone therapy washouts, and pregnancy plans are common filters. This hub does not advise on surgery or fertility."},{"slug":"heart-failure","name":"Heart failure","query":"heart failure","group":"Heart and lung","blurb":"SGLT2 drugs, devices, and rehab programs for reduced or preserved ejection fraction.","searchIntent":"heart failure clinical trials","intro":"Heart-failure records split HFrEF vs HFpEF, and sometimes acute decompensated hospital studies. Ejection fraction, NT-proBNP, and guideline medicines appear in eligibility. Device studies (ICD, CRT, monitors) are separate from drug studies."},{"slug":"atrial-fibrillation","name":"Atrial fibrillation","query":"atrial fibrillation","group":"Heart and lung","blurb":"Ablation, anticoagulants, and rhythm-control studies for AFib.","searchIntent":"atrial fibrillation clinical trials","intro":"AFib trials may study ablation, medicines for rhythm or rate, left-atrial appendage devices, or stroke-prevention anticoagulants. CHA2DS2-VASc and bleeding history often appear. We do not recommend stopping a blood thinner."},{"slug":"hypertension","name":"High blood pressure","query":"hypertension","group":"Heart and lung","blurb":"Medicine, device, and lifestyle studies for high blood pressure.","searchIntent":"hypertension clinical trials","intro":"Hypertension studies set office or ambulatory blood-pressure ranges and a count of current medicines (including resistant hypertension). Device studies such as renal denervation have their own records. Home readings on this site are not a diagnosis."},{"slug":"asthma","name":"Asthma","query":"asthma","group":"Heart and lung","blurb":"Biologics, inhaler combinations, and studies for severe or eosinophilic asthma.","searchIntent":"asthma clinical trials","intro":"Asthma trials often require a recent exacerbation count, FEV1 range, and eosinophil or FeNO data for biologic studies. Pediatric protocols are separate. We do not adjust inhalers or interpret spirometry."},{"slug":"copd","name":"COPD","query":"chronic obstructive pulmonary disease","group":"Heart and lung","blurb":"Inhalers, biologics, and rehab studies for chronic obstructive pulmonary disease.","searchIntent":"COPD clinical trials","intro":"COPD records usually need spirometry confirming obstruction, a smoking history, and exacerbation counts. Some studies enroll eosinophilic COPD for biologics. Oxygen use and recent pneumonia can be exclusions. Confirm on the NCT page."},{"slug":"sleep-apnea","name":"Sleep apnea","query":"obstructive sleep apnea","group":"Heart and lung","blurb":"Devices, GLP-1 medicines, and surgery alternatives to CPAP.","searchIntent":"sleep apnea clinical trials","intro":"Obstructive sleep apnea trials may require a recent sleep study (AHI), CPAP intolerance, or a BMI range for medicine studies. Central sleep apnea is a different condition. We do not interpret your sleep study."},{"slug":"long-covid","name":"Long COVID","query":"long COVID","group":"Infection","blurb":"Trials for fatigue, brain fog, autonomic symptoms, and lingering viral effects.","searchIntent":"long covid clinical trials","intro":"Long COVID (PASC) records define a time since infection and a symptom cluster. Some studies require documented SARS-CoV-2; others allow suspected infection. Treatments range from rehab to investigational drugs. Evidence is still evolving — the NCT page states what is being tested, not what is proven."},{"slug":"hiv","name":"HIV","query":"HIV","group":"Infection","blurb":"Antiretroviral, long-acting, cure-related, and prevention (PrEP) studies.","searchIntent":"HIV clinical trials","intro":"HIV records include treatment, long-acting ART, cure-related research, and prevention (PrEP). Viral load, CD4, and current regimen usually decide treatment-study eligibility. Prevention studies enroll people without HIV. Do not mix those NCT numbers."},{"slug":"sickle-cell","name":"Sickle cell disease","query":"sickle cell","group":"Blood","blurb":"Gene therapy, voxelotor-era follow-ons, and crisis-prevention studies.","searchIntent":"sickle cell clinical trials","intro":"Sickle cell studies may enroll children or adults, and they often count vaso-occlusive crises in the past year. Gene-therapy records have transplant-like eligibility and follow-up. Hydroxyurea use is frequently specified. This is not an emergency sickle-cell service."},{"slug":"macular-degeneration","name":"Macular degeneration","query":"age-related macular degeneration","group":"Eye","blurb":"Injections, gene therapy, and geographic-atrophy studies for AMD.","searchIntent":"macular degeneration clinical trials","intro":"AMD trials split dry (including geographic atrophy) versus wet/neovascular disease. Visual-acuity floors, recent anti-VEGF injections, and imaging (OCT) rules are typical. An eye-trial listing is not an appointment with a retina clinic."},{"slug":"ibs","name":"IBS","query":"irritable bowel syndrome","group":"Immune and joints","blurb":"Diet, microbiome, and medicine studies for irritable bowel syndrome.","searchIntent":"IBS clinical trials","intro":"IBS trials specify IBS-C, IBS-D, or mixed type using Rome criteria. They are not Crohn's or ulcerative colitis studies. Diet, microbiome, neuromodulator, and secretagogue records all appear. We do not prescribe a diet."}],"drugs":[{"slug":"semaglutide","name":"Semaglutide","query":"semaglutide","aliases":["Ozempic","Wegovy","Rybelsus"],"blurb":"A GLP-1 weekly shot (and a daily pill) being tested far beyond diabetes — obesity, heart, kidney, liver, and addiction studies.","intro":"Registry cards that name semaglutide (including brand names Ozempic, Wegovy, and Rybelsus) are grouped here. Indications on the registry may be diabetes, obesity, or another condition under study. Brand names are identifiers from ClinicalTrials.gov, not advertisements."},{"slug":"tirzepatide","name":"Tirzepatide","query":"tirzepatide","aliases":["Mounjaro","Zepbound"],"blurb":"A dual GIP/GLP-1 weekly shot. Trials now cover weight, sleep apnea, heart failure, and fatty liver.","intro":"Tirzepatide appears on ClinicalTrials.gov under generic and brand names (Mounjaro, Zepbound). This hub lists recruiting records that mention it as an intervention. We do not compare it with other GLP-1 medicines."},{"slug":"retatrutide","name":"Retatrutide","query":"retatrutide","aliases":["LY3437943"],"blurb":"An investigational triple-agonist studied for obesity and metabolic disease.","intro":"Retatrutide is an investigational medicine on the registry. Listings here are studies, not an approved-use guide. Dose, indication, and eligibility are only on the NCT record."},{"slug":"pembrolizumab","name":"Pembrolizumab","query":"pembrolizumab","aliases":["Keytruda"],"blurb":"A PD-1 immunotherapy used across many cancers. New trials test earlier use, combinations, and shorter courses.","intro":"Pembrolizumab (Keytruda) records span many tumor types. A trial that names it is not automatically open to every cancer. Tumor type, PD-L1, and prior immunotherapy rules are on the official card."},{"slug":"nivolumab","name":"Nivolumab","query":"nivolumab","aliases":["Opdivo"],"blurb":"A PD-1 immunotherapy studied alone and with ipilimumab or chemotherapy.","intro":"Nivolumab (Opdivo) appears across solid tumors and some hematologic studies. Combination records (for example with ipilimumab) have different eligibility than monotherapy. We do not rank checkpoint drugs."},{"slug":"trastuzumab-deruxtecan","name":"Trastuzumab deruxtecan","query":"trastuzumab deruxtecan","aliases":["Enhertu","T-DXd"],"blurb":"An HER2-directed antibody-drug conjugate studied in breast, lung, gastric, and other tumors.","intro":"T-DXd / Enhertu studies usually require a documented HER2 or HER2-low status that matches the protocol. Tumor type matters. Confirm IHC/ISH requirements on ClinicalTrials.gov."},{"slug":"osimertinib","name":"Osimertinib","query":"osimertinib","aliases":["Tagrisso"],"blurb":"An EGFR tyrosine-kinase inhibitor studied in lung cancer and related settings.","intro":"Osimertinib (Tagrisso) records typically require an EGFR mutation listed in the protocol. Adjuvant, first-line, and post-progression studies are different NCT numbers. We do not interpret your NGS report."},{"slug":"sotorasib","name":"Sotorasib","query":"sotorasib","aliases":["Lumakras"],"blurb":"A KRAS G12C inhibitor studied in lung cancer and other G12C tumors.","intro":"Sotorasib studies generally require a KRAS G12C result. Combinations and new tumor types appear as separate records. Mutation reports belong with the study team, not with this rewrite."},{"slug":"lecanemab","name":"Lecanemab","query":"lecanemab","aliases":["Leqembi"],"blurb":"An anti-amyloid antibody for early Alzheimer's. Trials look at prevention, dosing, and who is most likely to benefit.","intro":"Lecanemab (Leqembi) studies often need amyloid confirmation and a study partner. ARIA monitoring rules are protocol-specific. This hub is not prescribing information."},{"slug":"donanemab","name":"Donanemab","query":"donanemab","aliases":["Kisunla"],"blurb":"Another anti-amyloid Alzheimer's antibody. Studies compare it with similar drugs and test stopping rules.","intro":"Donanemab (Kisunla) records are Alzheimer's or related amyloid studies unless the registry says otherwise. Imaging and APOE-related exclusions can appear. Read the NCT eligibility block."},{"slug":"ketamine","name":"Ketamine","query":"ketamine depression","aliases":["esketamine","Spravato"],"blurb":"Rapid-acting depression treatment. Trials test dose, route (IV vs. nasal), and how to keep the effect from fading.","intro":"Ketamine and esketamine (Spravato) studies are usually psychiatry protocols with monitoring requirements. They are not the same as recreational use. Suicidality and substance-use exclusions are common — see the official record."},{"slug":"psilocybin","name":"Psilocybin","query":"psilocybin","aliases":["COMP360"],"blurb":"A psychedelic being studied for depression, addiction, and end-of-life distress — always with therapy, not as a take-home pill.","intro":"Psilocybin trials on ClinicalTrials.gov are supervised research, typically with psychotherapy sessions. They are illegal to copy at home. Listings here describe recruiting research protocols only."},{"slug":"car-t","name":"CAR-T therapy","query":"CAR-T","aliases":["chimeric antigen receptor"],"blurb":"A patient's own immune cells are reprogrammed to attack cancer. Trials are expanding from blood cancers into solid tumors and autoimmune disease.","intro":"CAR-T records specify a target (CD19, BCMA, and others), a disease, and often a manufacturing wait. Autoimmune CAR-T studies are not interchangeable with oncology protocols. Slot availability is never guaranteed by this site."},{"slug":"dupilumab","name":"Dupilumab","query":"dupilumab","aliases":["Dupixent"],"blurb":"An IL-4/IL-13 antibody studied in asthma, eczema, eosinophilic diseases, and COPD-overlap trials.","intro":"Dupilumab (Dupixent) appears across atopic and eosinophilic conditions. A trial for asthma is not an eczema trial. Indication and prior-biologic washouts are on the NCT card."},{"slug":"ocrelizumab","name":"Ocrelizumab","query":"ocrelizumab","aliases":["Ocrevus"],"blurb":"A B-cell antibody used in multiple sclerosis. Trials test earlier use, dosing, and progressive disease.","intro":"Ocrelizumab (Ocrevus) studies are typically MS protocols (relapsing or primary progressive). Infection and vaccine exclusions are common. 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Paulo","country":"Brazil","trialCount":47},{"slug":"strasbourg-france","city":"Strasbourg","state":"Alsace","country":"France","trialCount":47},{"slug":"hanover-germany","city":"Hanover","state":"Lower Saxony","country":"Germany","trialCount":47},{"slug":"seongnam-si-south-korea","city":"Seongnam-si","state":"Kyonggi-do","country":"South Korea","trialCount":47},{"slug":"fort-myers-florida","city":"Fort Myers","state":"Florida","country":"United States","trialCount":47},{"slug":"syracuse-new-york","city":"Syracuse","state":"New York","country":"United States","trialCount":47},{"slug":"sarasota-florida","city":"Sarasota","state":"Florida","country":"United States","trialCount":47},{"slug":"campinas-brazil","city":"Campinas","state":"","country":"Brazil","trialCount":47},{"slug":"ia-i-romania","city":"Iași","state":"","country":"Romania","trialCount":47},{"slug":"bras-lia-brazil","city":"Brasília","state":"Federal District","country":"Brazil","trialCount":47},{"slug":"nanning-china","city":"Nanning","state":"","country":"China","trialCount":47}],"trials":[{"nctId":"NCT00001160","title":"Studies on Tumors of the Thyroid","officialTitle":"Studies on Thyroid Nodules and Thyroid Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer.\n\nThe main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies....","conditions":["Hurthle Cell Thyroid Cancer","Tall Cell Variant Thyroid Cancer","Follicular Thyroid Cancer","Thyroid Cancer","Papillary Thyroid Cancer"],"keywords":["Thyroid Fine Needle Biopsy","Radioiodine","Dosimetry","Natural History"],"interventions":[{"type":"DRUG","name":"68-Gallium Dotatate"}],"enrollment":2500,"startDate":"1977-06-01","completionDate":null,"sex":"ALL","minAge":"6 Months","maxAge":"98 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, adults or children \\>= 6 months+.\n2. Patients with known or suspected thyroid nodules and/or thyroid cancer.\n3. At risk family members of patients who have a genetic susceptibility to developing thyroid cancer.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1\\. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Padmasree Veeraraghavan, R.N.","phone":"(301) 451-7710","email":"padmasree.veeraraghavan@nih.gov"},{"name":"Joanna Klubo-Gwiezdzinska, M.D.","phone":"(301) 496-5052","email":"joanna.klubo-gwiezdzinska@nih.gov"}],"primaryOutcomes":["Evaluation of thyroid cancer","Evaluation of thyroid disorders"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: testing 68-Gallium Dotatate for Hurthle Cell Thyroid Cancer","inPlainEnglish":"Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer. The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer.","whoItsFor":["Ages 6 Months to 98 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Male or female, adults or children \\>= 6 months+","Patients with known or suspected thyroid nodules and/or thyroid cancer","At risk family members of patients who have a genetic susceptibility to developing thyroid cancer"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","1\\. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma requiring intervention before thyroid cancer is addressed"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,500 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.338Z"},{"nctId":"NCT00001238","title":"Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders","officialTitle":"Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Renal and Other Urologic Malignant Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled. Affected individuals or individuals suspected of having a germline urologic malignant disorder will undergo periodic clinical assessment and genetic analyses for the purpose of: 1) definition and characterization of phenotype, 2) determination of the natural history of the disorder, and 3) genotype/phenotype correlation. Genetic linkage studies may be performed in situations in which the genetic basis of the disorder has not been elucidated.","conditions":["Kidney Cancer","Urologic Malignant Disorders","Renal Cell Carcinoma","Familial Renal Cancer (FRC)","Clear Cell Renal Cancer"],"keywords":["Hereditary Papillary Renal Cancer (HPRC)","Birt Hogg Dube (BHD)","Hereditary Leiomyomatosis and Renal Cell Carcinoma (HLRCC)","Pheochromocytoma","Von Hippel-Lindau (VHL)"],"interventions":[],"enrollment":5000,"startDate":"1990-12-05","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants must be greater than or equal to 2 years of age. All participants and guardians (for children younger than 18 years of age) must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nCriteria for Acceptance into this Study (i.e., Disease Categories):\n\nDisease Category I\n\nIndividuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is known, including von Hippel-Lindau (VHL) and hereditary papillary renal carcinoma (HPRC).\n\nDisease Category II\n\nIndividuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is not yet known, specifically hereditary forms of Type II papillary renal cancer, clear cell renal carcinoma, renal oncocytoma, chromophobe renal carcinoma or Birt Hogg Dube.\n\nDisease Category III\n\nIndividuals and biologic family members who have urologic malignant diseases of suspected, but not proven genetic etiology, including families with more than one individual affected by the same or related cancers. A total of 5000 individuals will be enrolled during the study (i.e., that includes individuals registered since the beginning of the protocols in 1989 (89C0086) and 1999 (99C0101)).\n\nEnrollment per Subject Category (to include both affected and unaffected biologic relatives)\n\nSubject Category A:\n\nCategory A will include individuals, and biologic relatives, who may or may not be affected who will be evaluated in the Warren G. Magnuson Clinical Center. Individuals in this category will be eligible if they or their biologic family members manifest one or more of the following features in a pattern suggestive of a heritable urologic malignant disorder:\n\n* One or more histologically proven or suspected renal carcinomas and/or cysts\n* Cerebellar, spinal, medullary or cerebral hemangioblastomas\n* Retinal angioma\n* Pancreatic neuro-endocrine carcinoma,micro cystadenoma and/or cysts\n* Pheochromocytoma\n* Papillary cystadenoma of the epididymis or broad ligament\n* Endolymphatic sac tumor\n* Cutaneous fibrofolliculomas or multiple skin-colored papules\n* History of spontaneous pneumothorax\n* Lung cysts\n* Thyroid carcinoma\n* Intestinal polyposis plus/minus colon cancer\n* Cutaneous or Uterine leiomyoma or uterine leiomyosarcoma, sarcoma\n\nSubject Category B:\n\nCategory B will include individuals and the biologic relatives of patients with inherited urologic malignancies with the above listed clinical findings who live at a distance and who will not be evaluated at the Clinical Center. In some cases, local diagnostic testing may be necessary for these individuals in addition to collection of a blood sample for molecular analysis.\n\nSubject Category C:\n\nCategory C will include biologic relatives who enroll in this study primarily for genetic linkage studies. These individuals will contribute a blood sample for DNA analysis only. No imaging diagnostic testing will be performed on individuals from this category.\n\nEXCLUSION CRITERIA:\n\nNone","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah A Nielsen, R.N.","phone":"(240) 760-6247","email":"deborah.nielsen@nih.gov"},{"name":"W. Marston Linehan, M.D.","phone":"(240) 858-3700","email":"linehanm@mail.nih.gov"}],"primaryOutcomes":["Identify and describe as yet unknown or uncharacterized inherited urologic malignant disorders.","Determine the genetic etiology of hereditary urologic malignant disorders in which the gene variation is unknown, by linkage analysis, positional cloning and evaluation of candidate genes.","Correlate specific mutations and their associated protein domains with disease phenotypic expression based on parameters including presenting age, clinical manifestations, histopathology and rate of recurrence.","Characterize the natural and clinical histories of inherited urologic malignant disorders."],"hasResults":false,"conditionSlugs":["kidney-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Von Hippel-Lindau (VHL): Clinical Manifestations, Diagnosis, Management and Molecular Bases of Inherited Re…","inPlainEnglish":"We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.","whoItsFor":["Ages 2 Years to any","Criteria for Acceptance into this Study (i.e., Disease Categories):","Individuals and biologic family members with a suspected or an established diagnosis of an inherited urologic malignancy in which the disease gene is known, including von Hippel-Lindau (VHL) and hereditary papillary renal carcinoma (HPRC)","Disease Category II","Disease Category III","Enrollment per Subject Category (to include both affected and unaffected biologic relatives)","Subject Category A:","One or more histologically proven or suspected renal carcinomas and/or cysts"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.924Z"},{"nctId":"NCT00001372","title":"Study of Systemic Lupus Erythematosus","officialTitle":"Studies of the Pathogenesis and Natural History of Systemic Lupus Erythematosus (SLE)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","sponsorClass":"NIH","summary":"This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.\n\nPatients 3 years of age and older with known or suspected SLE and their relatives may be eligible for this study. Patients will be evaluated with a medical history and physical examination, blood and urine tests. Other procedures may include:\n\n1. Electrocardiogram\n2. 24-hour urine collection\n3. Imaging studies, such as chest and joint X-rays, magnetic resonance imaging (MRI) scans, bone scans, and bone densitometry.\n4. Questionnaire about the degree of disease activity, and survey of risk factors for disease complications.\n5. Apheresis-Collection of plasma (fluid portion of blood) or blood cells for analysis. Whole blood is collected through a needle in an arm vein. The blood circulates through a machine that separates it into its components. The required component (plasma or cells) is removed and the rest of the blood is returned to the body through the same needle or through a second needle in the other arm.\n6. Skin biopsy-Removal of a small skin sample for microscopic analysis. An area of skin is numbed with an anesthetic and a small circular portion (about 1/4 inch in diameter) is removed, using a sharp cookie cutter-type instrument.\n7. Kidney, bone marrow or other organ biopsy-Removal of a small sample of organ tissue. These biopsies are done only if they can provide information useful in better understanding the disease or making treatment decisions.\n8. Genetic studies-Collection of a blood sample for gene testing.\n\nPatients will be followed at least once a year with a brief history and physical examination and routine blood and urine tests. Some patients may be seen more often. Treatment recommendations will be offered to patients' physicians, and patients who are eligible for other research treatment studies will be invited to enroll.\n\nParticipating relatives of patients will fill out a brief medical history questionnaire and provide a DNA sample (either a blood sample or tissue swab from the inside of the cheek) for genetic testing.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Longitudinal Study","Natural History","Lupus Nephritis","Lupus","Systemic Lupus","SLE"],"interventions":[],"enrollment":2000,"startDate":"1994-02-10","completionDate":null,"sex":"ALL","minAge":"3 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients with known or suspected SLE will be evaluated in either the outpatient or inpatient research ward of the Clinical Center as indicated. Patients will not be selected based on age, race or gender. However, due to the nature of the disease, the patient population will not be expected to be evenly distributed, since SLE is predominantly a disease of young females, with increased prevalence in select racial groups, particularly African Americans and Hispanics. First and second-degree relatives of the patient may be recruited in the study for genetic analysis. We will ask for the patient s permission to contact his/her relatives.\n\n* SLE or suspected SLE established by ACR/EULAR or ACR criteria\n* Ability to give informed consent\n* Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)\n* Ability of the patient or minor relative s parents to give informed consent\n* Affected individuals age \\>= 3 years with no upper age limit\n* Healthy Volunteers (non-related) age \\>=18 with no upper age limit\n* Healthy Volunteers (first- and second-degree relatives) age \\>=3 with no upper age limit\n* Vascular studies adults only age \\>=18 with no upper age limit\n\nEXCLUSION CRITERIA:\n\n* Concomitant medical problems which would confound the interpretation of studies gathered by this protocol. Included in this is the presence of HIV in the blood, active malignancies, or other significant medical conditions that may interferes with interpretation of some lupus studies.\n* Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH\n* Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)\n* Any comorbidity of medical or psychological/psychiatric condition or treatment after reviewing of patients previous or outside medical records, that in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or other procedures)\n* Unwilling to participate in research studies or to provide research samples or data\n* Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for\n\nEXCLUSION CRITERIA FOR VASCULAR STUDIES ONLY, FOR SLE AND HEALTHY CONTROLS:\n\n* Subjects with a contraindication to MRI scanning will not receive the optional Cardiovascular MRI. These contraindications include subjects with the following devices:\n\n  * Central nervous system aneurysm clips unless it is labeled safe or conditional for MRI\n  * Implanted neural stimulator (e.g.TENS-Unit) unless it is labeled safe or conditional for MRI\n  * Implanted cardiac pacemaker or defibrillator unless it is labeled safe or conditional for MRI\n  * Cochlear or any type of ear implant unless it is labeled safe or conditional for MRI\n  * Ocular foreign body (e.g. metal shavings)\n  * Implanted Insulin pump or drug infusion device unless it is labeled safe or conditional for MRI\n  * Metal shrapnel or bullet unless cleared by plain x-ray as safe for MRI\n* Subjects with renal excretory dysfunction, estimated glomerular filtration rate \\< 60 mL/min/1.73m\\^2 using the CKD-EPI equation or equivalent (using the CRIS-calculated eGFR to define the threshold) and a serum creatinine measured within 2 weeks without intercurrent change in medical condition or medications. Subjects meeting this exclusion criterion may still be included in the study but will not be exposed to the cardiac CT angiography, or gadolinium-based contrast agents.\n* Pregnant or lactating women will be excluded from vascular studies.\n* Any clinical instability precluding subject from getting MRI as determined by the enrolling clinician.\n* Healthy controls with known history of coronary artery disease, peripheral vascular disease or atherosclerosis.\n* Individuals younger than 18 years old will be excluded given the radiation exposure as well as the lack of proper validation for the proposed vascular function studies.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarfaraz A Hasni, M.D.","phone":"(301) 451-1599","email":"hasnisa@mail.nih.gov"}],"primaryOutcomes":["Natural History of SLE"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Study of Systemic Lupus Erythematosus","inPlainEnglish":"This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.","whoItsFor":["Ages 3 Years to 120 Years","SLE or suspected SLE established by ACR/EULAR or ACR criteria","Adult and minor relatives (first and second degree) of individuals Included in IV-G (only for genetic studies)","Affected individuals age \\>= 3 years with no upper age limit","Healthy Volunteers (non-related) age \\>=18 with no upper age limit","Healthy Volunteers (first- and second-degree relatives) age \\>=3 with no upper age limit","Vascular studies adults only age \\>=18 with no upper age limit"],"whoShouldSkip":["Concomitant medical, surgical or other conditions for which inadequate facilities are available to support their care at NIH","Inability or unwillingness to comply with follow up requirements (e.g. distance, social, physical limitations)","Any concomitant medical problems or are taking medications which would confound the interpretation of studies they are considered for"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.282Z"},{"nctId":"NCT00001373","title":"Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics","officialTitle":"An Exploratory Study of the Genetics, Pathophysiology, and Natural History of Autoinflammatory Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Human Genome Research Institute (NHGRI)","sponsorClass":"NIH","summary":"This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases.\n\nThe following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.\n\nPatients will undergo a medical and family history, physical examination, blood and urine tests. Additional tests and procedures may include the following:\n\n1. X-rays\n2. Consultations with specialists\n3. DNA sample collection (blood or saliva sample) for genetic studies. These might include studies of specific genes, or more complete sequencing of the genome.\n4. Additional blood samples a maximum of 1 pint (450 ml) during a 6-week period for studies of white cell adhesion (stickiness)\n5. Leukapheresis for collecting larger amounts of white cells for study. For this procedure, whole blood is collected through a needle in an arm vein. The blood flows through a machine that separates it into its components. The white cells are removed and the rest of the blood is returned to the body through another needle in the other arm.\n\nPatients may be followed approximately every 6 months to monitor symptoms, adjust medicine dosages, and undergo routine blood and urine tests. They will receive genetic counseling by the study team on the risk of having affected children and be advised of treatment options.\n\nParticipating relatives will undergo a medical and family history, possibly with a review of medical records, physical examination, blood and urine tests. Additional procedures may include a 24-hour urine collection, X-rays, and consultations with medical specialists. A DNA sample (blood or saliva) will also be collected for genetic studies. Additional blood samples of no more than 550 mL during an 8-week period may be requested for studies of white cell adhesion (stickiness).\n\nRelatives who have familial Mediterranean fever, TRAPS, or hyper-IgD syndrome will receive the same follow-up and counseling as described for patients above.\n\nNormal volunteers and patients with gout will have a brief health interview and check of vital signs (blood pressure and pulse) and will provide a blood sample (up to 90 ml, or 6 tablespoons). Additional blood samples of no more than 1 pint over a 6-week period may be requested in the future.","conditions":["Familial Mediterranean Fever (FMF)","Autoinflammation","Periodic Fever","Fever","Genetic Diseases","ROSAH","ALPK1"],"keywords":["Splenomegaly","Retinal Dystrophy","Periodic Fever","Optic Nerve Edema","HEADACHE","Genetics","Familial Mediterranean","Autoinflammation","Anhidrosis","Alpha-Kinase 1"],"interventions":[],"enrollment":5000,"startDate":"1994-03-10","completionDate":null,"sex":"ALL","minAge":"2 Months","maxAge":"115 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nThere are three populations that will be included in this study: subjects with known or suspected autoinflammatory diseases, family members of subjects with known or suspected autoinflammatory diseases, and healthy controls. Persons interested in participation may be given a screening questionnaire to determine eligibility. Questions in the screening questionnaire are important to help us determine if subjects have known autoinflammatory diseases, or if there is a high clinical suspicion of autoinflammatory disease.\n\nIn order to be eligible to participate in this study as a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:\n\n1. Stated willingness to participate in study procedures (which at the very least includes providing a mail-in sample for genetic analysis);\n2. Regardless of gender, at least one month of age;\n3. A medical history that, in the expert opinion of the study team, is consistent with the possibility of autoinflammatory disease; and\n4. Ability of the subject, parents (in the case of children), or Legally Authorized Representative to understand and the willingness to sign a written informed consent document.\n\nIn order to be eligible to participate in this study as a family member of a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:\n\n1. Stated willingness to participate in study procedures (which at the very least includes providing a mail-in sample for genetic analysis);\n2. Regardless of gender, at least one month of age;\n3. Relationship, either by blood or marriage, to an individual enrolled or about to be enrolled in the study with known or suspected autoinflammatory disease;\n4. Likelihood, in the expert opinion of the study team, that analysis of a sample from the individual would advance genetic or functional analysis of the affected relative's possible autoinflammatory condition; and\n5. Ability of the subject, parents (in the case of children), or Legally Authorized Representative to understand and the willingness to sign a written informed consent document.\n\nIn order to be eligible to participate in this study as a healthy volunteer, an individual must meet all of the following criteria:\n\n1. Stated willingness to participate in study procedures for healthy volunteers;\n2. Regardless of gender, at least one year old, and not pregnant (by history of a missed menstrual period);\n3. Likelihood, in the expert opinion of the study team, that a sample from the individual would advance the functional analysis of an autoinflammatory condition under study; and\n4. Ability of the subject or parents (in the case of children) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nFor any of the three categories of subjects, an individual will be excluded from participation in this study if he or she has a medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.","locations":[{"facility":"Childrens National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Walter Reed National Medical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amanda K Ombrello, M.D.","phone":"(301) 827-4258","email":"ombrelloak@mail.nih.gov"},{"name":"Benjamin D Solomon, M.D.","phone":"(301) 402-8824","email":"solomonb@mail.nih.gov"}],"primaryOutcomes":["Genetic linkage in autoinflammatory dise"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","baltimore-maryland","bethesda-maryland","pittsburgh-pennsylvania"],"enrichment":{"headline":"Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics","inPlainEnglish":"This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.","whoItsFor":["Ages 2 Months to 115 Years","In order to be eligible to participate in this study as a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:","Stated willingness to participate in study procedures (which at the very least includes providing a mail-in sample for genetic analysis);","Regardless of gender, at least one month of age;","A medical history that, in the expert opinion of the study team, is consistent with the possibility of autoinflammatory disease; and","In order to be eligible to participate in this study as a family member of a subject with known or suspected autoinflammatory disease, an individual must meet all of the following criteria:","Relationship, either by blood or marriage, to an individual enrolled or about to be enrolled in the study with known or suspected autoinflammatory disease;","Likelihood, in the expert opinion of the study team, that analysis of a sample from the individual would advance genetic or functional analysis of the affected relative's possible autoinflammatory condition; and"],"whoShouldSkip":["For any of the three categories of subjects, an individual will be excluded from participation in this study if he or she has a medical condition that would, in the opinion of the investigators, confuse the interpretation of the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.929Z"},{"nctId":"NCT00001465","title":"Study of the Disease Process of Lymphangioleiomyomatosis","officialTitle":"Characterization of the Pathogenesis of Lymphangioleiomyomatosis (LAM)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.\n\nThis study is designed to determine the disease processes involved at the level of cells and molecules, in order to develop more effective therapy.\n\nResearchers intend to identify the proteins and genes that contribute to the process of lung destruction in affected individuals.","conditions":["Lung Disease","Pneumothorax","Tuberous Sclerosis","Lymphangioleiomyomatosis"],"keywords":["Smooth Muscle Proliferation","Bronchoscopy","Female","Pneumothorax","Tuberous Sclerosis","Natural History"],"interventions":[{"type":"DEVICE","name":"Toshibia Aquilion One CT"}],"enrollment":2000,"startDate":"1995-12-18","completionDate":null,"sex":"ALL","minAge":"16 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nGeneral admission criteria for patients include one or both of the following:\n\nFindings on lung biopsy diagnostic of LAM;\n\nFindings on chest x-ray and/or chest computed axial tomography consistent with LAM.\n\nPatients with TSC and pulmonary LAM will be included in the study.\n\nNormal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease.\n\nNormal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM.\n\nPregnant and or nursing women including pregnant minors may be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and/or nursing. A minor participant with a positive pregnancy test result will be informed promptly. The result will be discussed in a sensitive and developmentally appropriate manner with the minor, including explanation of the result, assessment of safety, and referral for appropriate follow-up care. The participant will be informed of the limits of confidentiality. The study team will encourage involvement of a parent or legal guardian when appropriate and safe. If there is concern for abuse, coercion, exploitation, or danger, the study team will follow applicable mandatory reporting laws and institutional policies, including notification of appropriate authorities and/or a parent or guardian when required to protect the participant or as otherwise required.\n\nProcedures that will not be completed while the subject is pregnant and/or nursing include: Arterial Blood Gases (ABG), HIV testing, treadmill test, lung biopsy, thoracentesis, bronchoscopy, and measurements with imaging modalities requiring contrast or with radiation exposure such as Chest x-ray, CT scan, MRI with or without contrast, lung scan, bone densitometry (DEXA). Allowing subjects to be included in the study may glean important information about individuals with uncommon pulmonary disease during and post pregnancy.\n\nRationale for inclusion of children (16 to \\< 18 years of age):\n\nLAM is a rare progressive disease that can manifest during adolescence, particularly in individuals with TSCassociated disease. Participation is expected to provide clinically meaningful evaluation and/or contribute important information about the natural history and presentation of LAM in younger patients. At age 16, the participant is generally capable of providing meaningful consent, understanding study procedures, and participating in discussions about risks, burdens, and potential benefits.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for patients include:\n\nAge less than 16.\n\nAdvanced stage of a pulmonary or a systemic illness in which the risk of the study is judged to be significant even in the absence of a clear contraindication to the procedures.\n\nExclusion criteria for patients for the formal exercise study and the stress echocardiogram include patients on continuous oxygen. Patients may perform an exercise test that will assess the patient's exercise capacity with activities of daily living.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tatyana A Worthy, R.N.","phone":"(301) 827-1376","email":"worthyt@mail.nih.gov"},{"name":"Joel Moss, M.D.","phone":"(301) 496-1597","email":"mossj@nhlbi.nih.gov"}],"primaryOutcomes":["Define the clinical course of the disease LAM andelucidate the pathogenesis of LAM at cellular and molecular levels"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Toshibia Aquilion One CT for Lung Disease","inPlainEnglish":"Pulmonary lymphangioleiomyomatosis (LAM) is a destructive lung disease typically affecting women of childbearing age. Currently, there is no effective therapy for the disease and the prognosis is poor.","whoItsFor":["Ages 16 Years to 100 Years","General admission criteria for patients include one or both of the following:","Findings on lung biopsy diagnostic of LAM;","Findings on chest x-ray and/or chest computed axial tomography consistent with LAM","Patients with TSC and pulmonary LAM will be included in the study","Normal non-smokers in the control group are defined as individuals who have not smoked for greater than or equal to 1 year and have no systemic or pulmonary disease","Normal smokers defined as individuals with no systemic or pulmonary disease, who have smoked for greater than or equal to 1 year and have normal chest x-ray and normal pulmonary function tests may be included if needed as controls for a similar population of patients with LAM","Rationale for inclusion of children (16 to \\< 18 years of age):"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.972Z"},{"nctId":"NCT00001532","title":"Role of Genetic Factors in the Development of Lung Disease","officialTitle":"Role of Genetic Factors in the Pathogenesis of Lung Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"This study is designed to evaluate the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease.\n\nThe study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers.\n\nOptional CT Sub-study\n\nThe standard CT scan will be compared to the low dose radiation CT scan for the 150 subjects enrolled in the sub-study to assess the variation between the two techniques. Specifically, the quantitative computer aided detection of lung CT abnormalities from LAM can be compared to assess whether low radiation dose CT exams is an alternative to conventional CT to monitor disease\n\nstatus.\n\nThis optional sub-study will be offered to up to 100 adult subjects with lung disease and up to 50 children age 9 and older with CF. Children will not be enrolled in the optional CT sub-study unless they have had a standard CT scan for medical purposes to use in comparison. One additional low dose radiation CT scan of the chest may be done as part of this sub-study when these subjects have their next annual CT scan.","conditions":["Cystic Fibrosis","Pulmonary Fibrosis","Tuberous Sclerosis","Asthma","Pulmonary Sarcoidosis"],"keywords":["Genetic Polymorphism","Nitric Oxide Synthesis","Alpha 1-Antitrypsin","Candidate Genes","Lung Pathology","Natural History","Lung Disease","Cystic Fibrosis","Asthma"],"interventions":[],"enrollment":3500,"startDate":"1996-09-13","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":"90 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion criteria for patients with AAT deficiency include: (1) Diagnosis of AAT with a confirmed phenotype considered in the high risk category; (2) Clinical phenotype consistent with potential genetic diseases and other genetic causes of lung diseases (3) symptoms consistent with pulmonary disease; (4) chest x-ray consistent with pulmonary disease; (5) pulmonary function tests consistent with pulmonary disease; (6) smokers, defined as individuals who are current smokers (1 pack per day for at least 2 years) and nonsmokers, defined as never-smokers or ex-smokers who have quit smoking three or more years ago;\n\nInclusion criteria for individuals with chronic obstructive pulmonary diseases include:\n\n1. symptoms consistent with pulmonary disease\n2. chest x-ray consistent with pulmonary disease\n3. pulmonary function tests consistent with pulmonary disease;\n4. smokers, defined as individuals who are current smokers (1 pack per day for at least 2 years) and nonsmokers, defined as never-smokers or ex-smokers who have not smoked for three or more years.\n\nInclusion criteria for patients with cystic fibrosis include a defined genetic mutation (i.e., any of the known variants of the CFTR gene, such as delta F508 allele) or a cystic fibrosis phenotype and clinical features consistent with this disease. Children with cystic fibrosis over eight years of age may be included.\n\nPatients with established diagnoses of sarcoidosis; mycobacterial infections; TSC (definite or possible); cystic lung diseases including genetic diseases; lymphangioleiomyomatosis or diseases associated with lymphatic disorders; history of pneumothorax; pulmonary fibrosis; asthma; histiocytosis X and diabetes mellitus will be included in this protocol. Relatives of patients may also be seen under this protocol. Children with lymphangiomatosis who are two years of age or older may be included. Participants with asthma may be enrolled at Suburban Hospital.\n\nResearch volunteers in the pulmonary control group are defined as individuals with no pulmonary disease (e.g. rheumatoid arthritis without evidence of pulmonary disease). Research volunteers in the diabetes control group are defined as individuals with no history of diabetes, coronary artery disease, or pulmonary disease.\n\nPregnant and or nursing women can be included in accordance with Federal Regulations at Subpart B of 45 CFR 46. Subjects who are pregnant and or nursing will be excluded from procedures during their pregnancy that are greater than minimal risk, until they are no longer pregnant and/or nursing. Procedures that will not be completed while the subject is pregnant and/or nursing including: PFTs, Six Minute Walk Test, thoracentesis, bronchoscopy, and measurements with imaging modalities requiring contrast or with radiation exposure such as Chest x-ray, CT scan, MRI. Allowing subjects to be included in the study may glean important information about individuals with uncommon pulmonary disease during and post pregnancy.\n\nPatients with abnormalities in ADP-ribosyltransferases, ADP-ribosyl-acceptor hydrolases, and their substrates. Children who are two years of age or older may be studied if they have a known defect in ADP-ribosylation, or if they have a family member with a defect in ADP-ribosylation and may be affected.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria for all participants include:\n\n1. age less than 18 or greater than 90 except for NIH patients with diseases /disorders as described in this protocol (except cystic fibrosis, lymphangiomatosis or defects in ADP-ribosylation) who are 16 years of age or older, patients with cystic fibrosis who are over eight years of age, patients who are two years of age or older with lymphangiomatosis or a known defect in ADP-ribosylation, or who have a family member with a defect in ADP-ribosylation, or unless patient-specific IRB approval is obtained and;\n2. inability to obtain reliable pulmonary function testing. As clarification, healthy volunteers, relatives of patients (except as noted for an ADP-ribosylation defect), and asthmatic patients from Suburban Hospital will be excluded if less than 18 or greater than 90 years of age.\n\nExclusion criteria for participating in the bronchoscopy portion of the study are:\n\n1. presence of any contraindication for fiberoptic bronchoscopy, with lavage and/or bronchial brushing;\n2. advanced stage of a pulmonary or a systemic illness such that the risk is judged to be significant even in the absence of a specific contraindication to the procedure\n3. allergy to topical anesthetic (e.g., lidocaine)\n4. current or recent respiratory infection (within the last 4 weeks)\n5. pregnancy or lactation\n6. age less than 18 or greater than 65.","locations":[{"facility":"Suburban Hospital","city":"Bethesda","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tatyana A Worthy, R.N.","phone":"(301) 827-1376","email":"worthyt@mail.nih.gov"},{"name":"Joel Moss, M.D.","phone":"(301) 496-1597","email":"mossj@nhlbi.nih.gov"}],"primaryOutcomes":["evaluating the role of hereditary factor"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Role of Genetic Factors in the Development of Lung Disease","inPlainEnglish":"This study is designed to measure the genetics involved in the development of lung disease by surveying genes involved in the process of breathing and examining the genes in lung cells of patients with lung disease. The study will focus on defining the distribution of abnormal genes responsible for processes directly involved in different diseases affecting the lungs of patients and healthy volunteers.","whoItsFor":["Ages 2 Years to 90 Years","who can join for individuals with chronic obstructive pulmonary diseases include:","symptoms consistent with pulmonary disease","chest x-ray consistent with pulmonary disease","pulmonary function tests consistent with pulmonary disease;","smokers, defined as individuals who are current smokers (1 pack per day for at least 2 years) and nonsmokers, defined as never-smokers or ex-smokers who have not smoked for three or more years"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,500 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.443Z"},{"nctId":"NCT00001778","title":"Evaluation of Patients With HAM/TSP","officialTitle":"Immuno-Virological Evaluation of Human T Cell Leukemia Virus Type-1 Associated Myelopathy (HAM/TSP)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Objective:\n\nHuman T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally. Additionally, we will attempt to define the virological and immunological changes of HAM/TSP.\n\nStudy Population:\n\nPatients with HAM/TSP who fulfill World Health Organization diagnostic criteria are eligible to participate in this protocol. Asymptomatic seropositive individuals and individuals with indeterminate HTLV-1 serology are also eligible to participate.\n\nDesign and Outcome Measures:\n\nA longitudinal assessment of clinical, virological and immunological progression in HAM/TSP will be accomplished through periodic testing and evaluation. Asymptomatic seropositive individuals, those with seroindeterminate HTLV-I serology and normal volunteers may serve as controls. Longitudinal standardized neurological examinations will be performed. Longitudinal samples of serum, plasma, and lymphocytes may be obtained from participants. Lumbar punctures may be performed on all participants. These samples will be used virological and immunological assays. A focus is on the relationships between the characteristics of viral infection, the immune response, and the genetic makeup.","conditions":["HTLV-I Infection","Tropical Spastic Paraparesis"],"keywords":["Immune Response","Sero-Indeterminant","Transmission","HTLV-1","HTLV-1 Associated Myelopathy","Natural History","HTLV-I","HAM/TSP"],"interventions":[],"enrollment":750,"startDate":"1998-04-06","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants that meet one of the following criteria:\n\n* Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot)\n* Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate)\n* Have a family member/significant other who is HTLV positive, and may have been exposed to the virus\n* Healthy volunteer AND\n* Willingness to participate in the protocol evaluations and procedures.\n\nEXCLUSION CRITERIA:\n\n* Unwillingness or inability to participate in the protocol evaluations and procedures.\n* The presence of any medical, social, or psychiatric conditions that in the opinion of the investigator may affect the safety of the patients or compliance with the protocol.\n* Patients/healthy volunteers under the age of 18 are excluded.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christopher Y Itoh, M.D.","phone":"(301) 496-3825","email":"christopher.itoh@nih.gov"},{"name":"Steven Jacobson, Ph.D.","phone":"(301) 496-3825","email":"jacobsons@ninds.nih.gov"}],"primaryOutcomes":["To characterize the baseline features of patients with HTLV infection with regards to clinical features, imaging studies, immunological markers, and viral studies."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Evaluation of Patients With HAM/TSP","inPlainEnglish":"Objective: Human T-lymphotropic virus type-I-associated myelopathy / tropical spastic paraparesis (HAM/TSP) is a rare neurologic disorder that affects less than 5% of patients infected with the HTLV-I virus. The purpose of this protocol is to study the natural history of HAM/TSP by monitoring clinical progression of patients longitudinally.","whoItsFor":["Ages 18 Years to 120 Years","Participants that meet one of the following criteria:","Test positive for HTLV infection (positive HTLV-1 ELISA followed by a positive Western blot)","Positive HTLV ELISA but a Western Blot that only partially fulfills the above criteria (seroindeterminate)","Have a family member/significant other who is HTLV positive, and may have been exposed to the virus","Healthy volunteer AND","Willingness to participate in the protocol evaluations and procedures"],"whoShouldSkip":["Unwillingness or inability to participate in the protocol evaluations and procedures","The presence of any medical, social, or psychiatric conditions that in the opinion of the investigator may affect the safety of the patients or compliance with the protocol","Patients/healthy volunteers under the age of 18 are excluded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 750 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.824Z"},{"nctId":"NCT00001823","title":"Evaluation for NCI Surgery Branch Clinical Research Protocols","officialTitle":"Evaluation for NCI Surgery Branch Clinical Research Protocols","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nThe National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient.\n\nObjective:\n\nThis study will allow patients to under screening and evaluation for participation in NC-SB Protocols.\n\nEligibility:\n\nPatients 18 years or older must meet the minimum eligibility criteria for an NCI-SB treatment protocol.\n\nDesign\n\nPatients will undergo testing and evaluations as required by the appropriate NCI-SB treatment protocol.\n\n...","conditions":["Synovial Cell Cancer","Melanoma","Colorectal Cancer","Lung Cancer","Bladder Cancer"],"keywords":["Cancer","Gene Therapy","Immunotherapy","Clinical Trial"],"interventions":[],"enrollment":7000,"startDate":"1999-07-11","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAge \\>= 18 years.\n\nPatient suspected of having, or with biopsy proven, malignant disease.\n\nPatient is able to understand and willing to sign a written informed consent document.\n\nPatient is being evaluated for treatment on an NCI-SB protocols.\n\nEXCLUSION CRITERIA:\n\nWomen of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI SB Immunotherapy Recruitment Center","phone":"(866) 820-4505","email":"irc@nih.gov"}],"primaryOutcomes":["Number of individuals suitable for NCI Surgery Branch clinical research protocols","Frequency of HLA type, gene specific mutations, or expression of neoantigens in malignant tumors","Results of screening tests"],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer","melanoma","bladder-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Evaluation for NCI Surgery Branch Clinical Research Protocols","inPlainEnglish":"Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.","whoItsFor":["Ages 18 Years to any","Patient suspected of having, or with biopsy proven, malignant disease","Patient is being evaluated for treatment on an NCI-SB protocols"],"whoShouldSkip":["Women of child-bearing potential who are pregnant or plan to become pregnant because of the potentially dangerous effects of some of the screening procedures (e.g., nuclear medicine or other imaging scans) on the fetus"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 7,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.062Z"},{"nctId":"NCT00001979","title":"Immune System Related Kidney Disease","officialTitle":"Studies of Immunologically-Mediated Kidney Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders.\n\nThis study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease.\n\nPatients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study.\n\nPatients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research.","conditions":["Kidney Disease","Nephrotic Syndrome"],"keywords":["Kidney Disease","Chronic Kidney Disease","Natural History"],"interventions":[],"enrollment":2000,"startDate":"1992-06-25","completionDate":null,"sex":"ALL","minAge":"10 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, a participant must meet all of the following criteria:\n\n1. Adults \\>= 18 years of age and children 10-17 years of age\n2. Participants with\n\n   1. known, proven, or suspected immunologically-mediated kidney diseases, including but not limited to nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with other systemic or connective tissue disorders, OR\n   2. immunologically-mediated diseases with the potential for kidney disease.\n3. Ability of the participant or guardian to understand and the willingness of the participant or guardian to provide written informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Concomitant medical problems which would confound the interpretation of studies of the immunologic kidney disorder.\n2. Concomitant medical, surgical, or other conditions for which inadequate facilities or funds are available to support their care at the NIH.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meryl A Waldman, M.D.","phone":"(301) 451-6990","email":"waldmanm@mail.nih.gov"}],"primaryOutcomes":["Provision of biospecimens"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","lupus"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Immune System Related Kidney Disease","inPlainEnglish":"Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney.","whoItsFor":["Ages 10 Years to 99 Years","In order to be eligible to participate in this study, a participant must meet all of the following criteria:","Adults \\>= 18 years of age and children 10-17 years of age","known, proven, or suspected immunologically-mediated kidney diseases, including but not limited to nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with other systemic or connective tissue disorders, OR","immunologically-mediated diseases with the potential for kidney disease"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Concomitant medical problems which would confound the interpretation of studies of the immunologic kidney disorder","Concomitant medical, surgical, or other conditions for which inadequate facilities or funds are available to support their care at the NIH"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.489Z"},{"nctId":"NCT00018057","title":"Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders","officialTitle":"Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Study Description:\n\nThis study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG). Patients will be studied over one year, before and after receiving either one of two standard-of-care treatments: cognitive behavioral therapy (CBT) or fluoxetine, a serotonin reuptake inhibitor (SSRI). Healthy comparisons will be studied at comparable time points.\n\nPrimary Objectives:\n\nTo compare healthy youth and symptomatic, medication-free pediatric patients studied prior to receipt of treatment. The study seeks to detect relations between clinical features of anxiety disorders at baseline and a wide range of neurocognitive features associated with attention, memory, and response to motivational stimuli.\n\nSecondary Objectives:\n\n1. To document relations between baseline neurocognitive features and response to Cognitive Behavioral Therapy (CBT) or fluoxetine, as defined by the Pediatric Anxiety Rating Scale (PARS) and Clinical Global Improvement (CGI) Scale.\n2. To document relations between post-treatment changes in neurocognitive features and anxiety symptoms on the PARS following treatment with Cognitive Behavioral Therapy (CBT) or fluoxetine.\n3. To document relations among broad arrays of clinical, cognitive, and neural measures\n\nPrimary Endpoints:\n\nIndices of percent-signal change in hypothesized brain regions, comprising amygdala, striatum, and prefrontal cortex (PFC) for each fMRI and MEG paradigm.\n\nSecondary Endpoints:\n\n1. Treatment-response as defined by a continuous measure, the Pediatric Anxiety Rating Scale score (PARS), and a categorial measure, the Clinical Global Improvement (CGI) score.\n2. Levels of symptoms and behaviors evoked by tasks that engage attention, memory, and elicit responses to motivational stimuli.\n\n   ...","conditions":["Anxiety Disorders","Major Depressive Disorder"],"keywords":["fMRI","Emotion","Normal Volunteers","Magnetic Resonance Imaging","CBT"],"interventions":[{"type":"BEHAVIORAL","name":"Attention Bias Modification Training"},{"type":"DRUG","name":"Fluoxetine"},{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy"}],"enrollment":3500,"startDate":"2001-10-02","completionDate":"2029-01-01","sex":"ALL","minAge":"8 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nALL JUVENILE SUBJECTS\n\n* Age: 8-17 (subjects who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17-year-olds but do not turn 18).\n* Consent: can give consent/assent (Parents will provide consent; minors will provide assent)\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL ADULT SUBJECTS\n\n* Age: 18-65\n* Consent: can give consent\n* IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)\n* Language: all subjects will speak English (Tasks in this protocol have not been validated in languages other than English)\n\nALL SUBJECTS WITH AN ANXIETY DISORDER\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))\n* Symptom Severity: Clinically significant, ongoing anxiety symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nALL PREVIOUSLY ENROLLED ADOLESCENT PATIENTS, CHILD AND ADULT HEALTHY VOLUNTEERS, AND ALL HEALTHY VOLUNTEERS TURNED PATIENTS\n\n* Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults))\n* Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n* Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.)\n\nEXCLUSION CRITERIA:\n\nALL SUBJECTS\n\n* Any serious medical condition or condition that interferes with fMRI or M/EEG scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. (All patients will complete a medical history. Healthy volunteer participants will be medication- free and have no current serious medical conditions, based on a review of their medical history. Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Pregnancy (Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)\n* Current use of any psychoactive substance; current suicidal ideation as indicated by the presence of intent for engaging in suicidal behaviors; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. (These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.)\n* Current diagnoses, major depressive disorder (MDD), post-traumatic distress disorder, conduct disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Past or current history of mania, psychosis, or severe pervasive developmental disorder. (These factors may be affected by SSRI treatment, influencing ability to detect effects on anxiety/symptoms of depression. Of note, subjects who present with a diagnosis of MDD will not be eligible for inclusion at the outset of the study. However, youth with anxiety disorders frequently develop MDD when followed over time. Subjects will be allowed to remain in the study if they develop these diagnoses after enrollment.)\n* Recent use of an SSRI with failure to respond or tolerate SSRI treatment at an adequate dose and duration. (This is designed to exclude subjects who have failed a trial of an SSRI for their current problem with anxiety. For previously enrolled participants, including patients and healthy volunteers, current use of an SSRI does not exclude participation from follow-up research tasks.)\n* History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence).\n\nHEALTHY ADULT SUBJECTS\n\n-Any current psychiatric diagnosis (Assessment relies on SCID)","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland, College Park","city":"College Park","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel S Pine, M.D.","phone":"(301) 594-1318","email":"daniel.pine@nih.gov"}],"primaryOutcomes":["Pediatric Anxiety Rating Scale (PARS)","Clinical Global Improvement (CGI) Scale"],"hasResults":false,"conditionSlugs":["depression","anxiety"],"drugSlugs":[],"locationSlugs":["bethesda-maryland","college-park-maryland"],"enrichment":{"headline":"Phase 2: testing Fluoxetine for Anxiety Disorders","inPlainEnglish":"Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders. The study uses neuro-cognitive tasks, functional magnetic resonance imaging (fMRI), as well as magneto- and electro-encephalography (M/EEG).","whoItsFor":["Ages 8 Years to 65 Years","ALL JUVENILE SUBJECTS","Age: 8-17 (subjects who consent as 17-year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17-year-olds but do not turn 18)","Consent: can give consent/assent (Parents will provide consent; minors will provide assent)","IQ: all subjects will have IQ\\>70 (Assessment relies on either a WASI or assessment by trained clinical staff during the subject s screening visit. Completion of required activities during the screening visit requires an IQ above 70.)","Consent: can give consent","ALL SUBJECTS WITH AN ANXIETY DISORDER","Diagnosis: Current Diagnosis of OCD, Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults))"],"whoShouldSkip":["Pregnancy (Subjects only will be excluded from the MRI portions of the study based on this exclusion criterion.)","History of any (excepting nicotine-related and cannabis-related) DSM5-defined moderate to severe substance use disorder (or DSM-IV-defined substance dependence)","HEALTHY ADULT SUBJECTS","Any current psychiatric diagnosis (Assessment relies on SCID)"],"whatHappens":"If you join, the listed intervention(s) are Attention Bias Modification Training, Fluoxetine, or Cognitive Behavioral Therapy. The registry lists allocation as randomized. Study Description: This study examines relations between neurocognitive and clinical features of pediatric anxiety disorders.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 3,500 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.105Z"},{"nctId":"NCT00026884","title":"Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease","officialTitle":"Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Selected individuals suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease. These samples will be stored in the tissue bank of the Urologic Oncology Branch. Aliquots of malignant and normal tissue will be collected at the time of surgery and stored in the tissue bank, Urologic Oncology Branch, NCI. These materials will be used in the research efforts of the Urologic Oncology Branch, NCI.","conditions":["Malignant Neoplasms","Hereditary Neoplastic Syndromes","Kidney Cancer","Renal Cancer","Bladder Cancer"],"keywords":["Serum","Collection of Tissue","Malignant Disease","Molecular Basis","Genome Sequencing","Natural History"],"interventions":[],"enrollment":5950,"startDate":"1998-03-12","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Individuals with biopsy-proven malignant disease\n* Individuals suspected of having a malignant disease\n* Individuals who have or are suspected of having an inherited genitourinary malignant disorder\n* Participants must be \\>= 2 years of age\n* A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder.\n* All participants and parents/guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nEXCLUSION CRITERIA:\n\n-Individuals whose co-morbidities preclude surgical intervention.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah A Nielsen, R.N.","phone":"(240) 760-6247","email":"deborah.nielsen@nih.gov"},{"name":"W. Marston Linehan, M.D.","phone":"(240) 858-3700","email":"linehanm@mail.nih.gov"}],"primaryOutcomes":["Investigate quality of life in men who have prostate cancer.","Investigate molecular genetic basis of urologic malignancies","Investigate cellular/biochemical response to existing and novel therapeutic agents.","Examine protein expression and bioimmunoassays investigating potential genetic markers.","Determine the molecular genetic differences between normal and tumorigenic tissues.","Collection of benign and malignant tissue from individuals with rare inherited conditions associated with an increased risk for kidney cancer.","Collection of benign and malignant tissue from individuals with known or suspected cancer."],"hasResults":false,"conditionSlugs":["kidney-cancer","bladder-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease","inPlainEnglish":"Selected individuals suspected of having or with prior biopsy proof of malignant disease will be seen in the Urologic Oncology Branch, NCI. Blood samples may be collected at the time of the initial visit and at periodic intervals during the course of the disease.","whoItsFor":["Ages 2 Years to any","Individuals with biopsy-proven malignant disease","Individuals suspected of having a malignant disease","Individuals who have or are suspected of having an inherited genitourinary malignant disorder","Participants must be \\>= 2 years of age","A relative (related by blood) of an individual with a confirmed or suspected diagnosis of a malignant disease or an inherited genitourinary malignant disorder"],"whoShouldSkip":["Individuals whose co-morbidities preclude surgical intervention"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,950 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.900Z"},{"nctId":"NCT00027274","title":"Cancer in Inherited Bone Marrow Failure Syndromes","officialTitle":"Etiologic Investigation of Cancer Susceptibility in Inherited Bone Marrow Failure Syndromes: A Natural History Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nA prospective cohort of Inherited Bone Marrow Failure Syndrome (IBMFS) will provide new information regarding cancer rates and types in these disorders.\n\nPathogenic variant(s) in IBMFS genes are relevant to carcinogenesis in sporadic cancers.\n\nPatients with IBMFS who develop cancer differ in their genetic and/or environmental features from patients with IBMFS who do not develop cancer.\n\nThese cancer-prone families are well suited for cancer screening and prevention trials targeting those at increased genetic risk of cancer.\n\nCarriers of IBMFS pathogenic variant(s) are at increased risk of cancer.\n\nThe prototype disorder is Fanconi's Anemia (FA); other IBMFS will also be studied.\n\nObjectives:\n\nTo determine the types and incidence of specific cancers in patients with an IBMFS.\n\nTo investigate the relevance of IBMFS pathogenic variant(s) in the carcinogenesis pathway of the sporadic counterparts of IBMFS-associated cancers.\n\nTo identify risk factors for IBMFS-related cancers in addition to the primary germline pathogenic variant(s).\n\nTo determine the risk of cancer in IBMFS carriers.\n\nEligibility:\n\nNorth American families with a proband with an IBMFS.\n\nIBMFS suspected by phenotype, confirmed by pathogenic variant(s) in an IBMFS gene, or by clinical diagnostic test.\n\nFanconi's anemia: birth defects, marrow failure, early onset malignancy; positive chromosome breakage result.\n\nDiamond-Blackfan anemia: pure red cell aplasia; elevated red cell adenosine deaminase.\n\nDyskeratosis congenita: dysplastic nails, lacey pigmentation, leukoplakia; marrow failure.\n\nShwachman-Diamond Syndrome: malabsorption; neutropenia.\n\nAmegakaryocytic thrombocytopenia: early onset thrombocytopenia.\n\nThrombocytopenia absent radii: absent radii; early onset thrombocytopenia.\n\nSevere Congenital Neutropenia: neutropenia, pyogenic infections, bone marrow maturation arrest.\n\nPearson's Syndrome: malabsorption, neutropenia, marrow failure, metabolic acidosis; ringed sideroblasts.\n\nOther bone marrow failure syndromes: e.g. Revesz Syndrome, WT, IVIC, radio-ulnar synostosis, ataxia-pancytopenia.\n\nFirst degree relatives of IBMFS-affected subjects as defined here, i.e. siblings (half or full), biologic parents, and children.\n\nGrandparents of IBMFS-affected subjects.\n\nPatients in the general population with sporadic tumors of the types seen in the IBMFS (head and neck, gastrointestinal, and anogenital cancer), with none of the usual risk factors (e.g. smoking, drinking, HPV).\n\nDesign:\n\nNatural history study, with questionnaires, clinical evaluations, clinical and research laboratory test, review of medical records, cancer surveillance.\n\nPrimary endpoints are all cancers, solid tumors, and cancers specific to each type of IBMFS.\n\nSecondary endpoints are markers of pre-malignant conditions, such as leukoplakia, serum or tissue evidence of carcinogenic viruses, and bone marrow morphologic myelodyplastic syndrome or cytogenetic clones.","conditions":["Diamond Blackfan Anemia","Dyskeratosis Congenita","Fanconi Anemia","Shwachman Diamond Syndrome","Inherited Bone Marrow Failure Syndrome, Aplastic Anemia"],"keywords":["Fanconi Anemia","Diamond Blackfan Anemia","Dyskeratosis Congenita","Shwachman Diamond Syndrome","Hereditary","Natural History","Fanconi's Anemia","Bone Marrow","Inherited Bone Marrow Failure Syndromes","IBMFS","Familial Cancer"],"interventions":[],"enrollment":4000,"startDate":"2001-11-28","completionDate":null,"sex":"ALL","minAge":"1 Day","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nThe participants will be affected by an IBMFS, or be members of a family with an IBMFS, and be at risk of being affected or carriers of the syndrome. Except for the rare X-linked recessive disorder (e.g. some dyskeratosis congenita patients), there should be equal numbers of male and female probands and family members. These IBMFS have been reported in most racial and ethnic groups, and thus all such groups will be included. The age range will be from birth to old age (grandparents of probands). The majority of the probands will be children (10-20% will be adults), and their parents and grandparents will be adults. All racial/ethnic groups are eligible.\n\nINCLUSION CRITERIA for Patients:\n\n* Fanconi s anemia.\n* Diamond Blackfan anemia.\n* Dyskeratosis congenita.\n* Shwachman Diamond Syndrome.\n* Amegakaryocytic thrombocytopenia.\n* Thrombocytopenia absent radii.\n* Severe Congenital Neutropenia.\n* Pearson Syndrome.\n* Other bone marrow failure syndromes.\n\nFamily Members of IBMFS - Affected Subjects:\n\n-Family members include first degree relatives of IBMFS-affected subjects as defined here, i.e. siblings (half or full), biologic parents, and children. Grandparents of IBMFS-affected subjects are also included, specifically for Hypothesis 4. The age range will be from birth to old age (grandparents of probands).\n\nPatients in the general population:\n\n-Patients in the general population with sporadic tumors of the types seen in the IBMFS (head and neck, gastrointestinal, and anogenital cancer), with none of the usual risk factors for those tumors (e.g. smoking, drinking, HPV). These patients will be further evaluated for an IBMFS by the referring physician under the guidance of the study investigators and if diagnosed with an IBMFS or if not diagnosed but highly suspicious for an IBMFS, would be eligible for inclusion in the Field and Clinic Center cohorts.\n\nEXCLUSION CRITERIA:\n\n-Affected: An individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Evidence that the hematologic disorder is acquired rather than genetic. Such evidence includes temporal relation of the aplastic anemia to known marrow suppressant drugs, chemicals, toxins, or viruses (in the absence of evidence indicative of an inherited marrow failure disorder).\n* Known causes of cytopenias such as autoantibodies to red cells, platelets, or neutrophils, viruses (especially hepatitis), micronutrient deficiencies, transient erythroblastopenia of childhood, and cyclic neutropenia.\n* Assignment of the patient s physical findings to other syndromes or causes that are not part of the IBMFS disease spectrum.\n* Inability of the participant or LAR to understand and be willing to sign a written informed consent document.\n* Unwillingness to permit access to medical records and pathology specimens.\n\nThere are no other exclusion parameters not related to the primary disease.\n\n-Unaffected/Family Members: An individual who meets any of the following criteria will be excluded from participation in this study:\n\n* If there is no affected individual in the family who meets the inclusion criteria\n* Inability of the participant or LAR to understand and be willing to sign a written informed consent document.\n* Unwillingness to permit access to medical records and pathology specimens.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Institute - Shady Grove","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Family Study Referrals","phone":"(800) 518-8474","email":"ncifamilystudyreferrals@mail.nih.gov"},{"name":"Lisa J McReynolds, M.D.","phone":"(240) 276-5047","email":"mcreynoldslj@mail.nih.gov"}],"primaryOutcomes":["Cohort of Families with IBMFS","Biology of Patients Compared with Healthy Controls","Differences Between Patients and Healthy Controls","Risk of Cancer with Specific Mutations"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland","rockville-maryland"],"enrichment":{"headline":"Cancer in Inherited Bone Marrow Failure Syndromes","inPlainEnglish":"Background: A prospective cohort of Inherited Bone Marrow Failure Syndrome (IBMFS) will provide new information regarding cancer rates and types in these disorders. Pathogenic variant(s) in IBMFS genes are relevant to carcinogenesis in sporadic cancers.","whoItsFor":["Ages 1 Day to 100 Years","who can join for Patients:","Diamond Blackfan anemia","Dyskeratosis congenita","Shwachman Diamond Syndrome","Amegakaryocytic thrombocytopenia","Thrombocytopenia absent radii","Severe Congenital Neutropenia"],"whoShouldSkip":["Affected: An individual who meets any of the following criteria will be excluded from participation in this study:","Known causes of cytopenias such as autoantibodies to red cells, platelets, or neutrophils, viruses (especially hepatitis), micronutrient deficiencies, transient erythroblastopenia of childhood, and cyclic neutropenia","Assignment of the patient s physical findings to other syndromes or causes that are not part of the IBMFS disease spectrum","Unwillingness to permit access to medical records and pathology specimens","There are no other exclusion parameters not related to the primary disease","Unaffected/Family Members: An individual who meets any of the following criteria will be excluded from participation in this study:","If there is no affected individual in the family who meets the who can join"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 4,000 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.444Z"},{"nctId":"NCT00033137","title":"Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer","officialTitle":"Birt-Hogg-Dub(SqrRoot)(Copyright) Syndrome: Characterization of the FLCN Disease Gene and Predisposition to Renal Cancer, Cutaneous Fibrofolliculoma and Pulmonary Cysts","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck. People with BHD are at increased risk of developing kidney cancer. Scientists have identified the chromosome (strand of genetic material in the cell nucleus) that contains the BHD gene and the region of the gene on the chromosome. This study will try to learn more about:\n\n* The characteristics and type of kidney tumors associated with BHD\n* The risk of kidney cancer in people with BHD\n* Whether more than one gene causes BHD\n* The genetic mutations (changes) responsible for BHD\n\nIndividuals with known or suspected Birt Hogg-Dube syndrome, and their family members, may be eligible for this study. Candidates will be screened with a family history and review of medical records, including pathology reports for tumors, and films of computed tomography (CT) and magnetic resonance imaging (MRI) scans.\n\nParticipants may undergo various tests and procedures, including the following:\n\n* Physical examination\n* Review of personal and family history with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor\n* Chest and other x-rays\n* Ultrasound (imaging study using sound waves)\n* MRI (imaging study using radiowaves and a magnetic field)\n* CT scans of the chest and abdomen (imaging studies using radiation)\n* Blood tests for blood chemistries and genetic testing\n* Skin evaluation, including a skin biopsy (surgical removal of a small skin tissue sample for microscopic evaluation)\n* Cheek swab or mouthwash to collect cells for genetic analysis\n* Lung function studies\n* Medical photography of skin lesions\n\nThese tests will be done on an outpatient basis in either one day or over 3 to 4 days. When the studies are complete, participants will receive counseling about the findings and recommendations. Individuals with kidney lesions may be asked to return periodically, such as every 3 to 36 months, based on their individual condition, to document the rate of progression of the lesions.\n\n...","conditions":["Kidney Neoplasms","Kidney Cancer","Pneumothorax","FLCN Protein, Human"],"keywords":["Pneumothorax","Kidney","Fibrofolliculoma","BHD","Neoplasms","Natural History"],"interventions":[],"enrollment":950,"startDate":"2002-05-13","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIndividuals that meet one or more of the following criteria:\n\n-Suspected or known to have phenotype or genotype suggestive of Birt-Hogg-Dube (BHD), such as:\n\n--Individuals with at least one histologically confirmed fibrofolliculomas;\n\nor\n\n--Individuals with clinical evidence of multiple skin papules (without fibrofolliculoma biopsy confirmation) and a personal or family history of spontaneous pneumothorax/or kidney cancer;\n\nor\n\n--Individuals with spontaneous pneumothorax and skin papules or kidney cancer and a positive family history of spontaneous pneumothorax, skin papules or kidney cancer;\n\nor\n\n--Individuals with a known germline FLCN gene mutation\n\nOR\n\n-Renal tumor histology consistent with BHD, including, but not limited to those suggestive of chromophobe, hybrid oncocytic neoplasm or oncocytoma.\n\nOR\n\n* Are a relative (related by blood) of an individual with a confirmed or suspected diagnosis of BHD.\n\n  -Participants must be \\>= 2 years of age.\n* For children less than 18 years of age, parental permission or legal guardian consent will be obtained.\n\nEXCLUSION CRITERIA:\n\nNone.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah A Nielsen, R.N.","phone":"(240) 760-6247","email":"deborah.nielsen@nih.gov"},{"name":"W. Marston Linehan, M.D.","phone":"(240) 858-3700","email":"linehanm@mail.nih.gov"}],"primaryOutcomes":["Identify genotype / phenotype correlations.","Determine risk of renal cancer, lung cysts and fibrofollicullomas in patients with BHD.","Determine if other genes contribute to BHD.","Define types and characteristics (including patterns of growth) of renal cancer associated with BHD.","Define the natural history of BHD related renal tumors."],"hasResults":false,"conditionSlugs":["kidney-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer","inPlainEnglish":"This study will investigate the genetic cause of Birt Hogg-Dube (BHD) syndrome and the relationship of this disorder to kidney cancer. BHD is a rare inherited condition characterized by papules, or bumps-benign tumors involving hair follicles-on the head and neck.","whoItsFor":["Ages 2 Years to any","Individuals that meet one or more of the following criteria:","Suspected or known to have phenotype or genotype suggestive of Birt-Hogg-Dube (BHD), such as:","Individuals with at least one histologically confirmed fibrofolliculomas;","Individuals with clinical evidence of multiple skin papules (without fibrofolliculoma biopsy confirmation) and a personal or family history of spontaneous pneumothorax/or kidney cancer;","Individuals with spontaneous pneumothorax and skin papules or kidney cancer and a positive family history of spontaneous pneumothorax, skin papules or kidney cancer;","Individuals with a known germline FLCN gene mutation","Renal tumor histology consistent with BHD, including, but not limited to those suggestive of chromophobe, hybrid oncocytic neoplasm or oncocytoma"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 950 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.900Z"},{"nctId":"NCT00034216","title":"Collection of Blood From Patients With Cancer","officialTitle":"Biospecimen Acquisition From Human Subjects","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate. This study does not involve treatment.\n\nParticipants will have about 50 ml (3 tablespoonfuls) of blood drawn. Depending on their condition, patients may be invited to enroll in a clinical research study involving chemotherapy, radiotherapy, or surgery. Additional 40-ml blood samples may be drawn during the course of treatment.","conditions":["Prostate Cancer","Breast Cancer","Colon Cancer","Lung Cancer","Liver Cancer"],"keywords":["Suppressor Cells","T-cells","CD4+ / CD25+ cells","Natural History","Cancer","Malignancy","Blood Sample"],"interventions":[],"enrollment":1750,"startDate":"2002-07-16","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible.\n\nPerformance status of ECOG 0, 1, 2, or 3 for admission to this protocol.\n\nAbility to understand and the willingness to sign a written informed consent document.\n\nINCLUSION FOR APHERESIS:\n\nNote: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference.\n\nHemoglobin greater than or equal to 10 mg/dL and platelet count \\> 75,000/mm(3)\n\nWeight greater than 25 kg\n\nHIV negative\n\nProthrombin Time - within normal limits\n\nPartial Thromboplastin Time - within normal limits\n\nMedically indicated central line in place or adequate peripheral venous access\n\nEXCLUSION CRITERIA:\n\nNone.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michell J Manu, R.N.","phone":"(240) 529-3415","email":"michell.manu@nih.gov"},{"name":"Jennifer L Marte","phone":"(301) 496-7214","email":"martej@mail.nih.gov"}],"primaryOutcomes":["Undertake genetic analysis of both prokaryotic and eukaryotic samples for advanced mutational analysis.","Correlate analysis results with clinical parameters such as demographics, toxicities, and treatment outcomes.","Collection of tissue, urine, saliva, stool and blood components, which include serum, leukocytes, peripheral blood mononuclear cells (PBMC), and circulating tumor cells (cTC), of human subjects."],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","liver-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Collection of Blood From Patients With Cancer","inPlainEnglish":"This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.","whoItsFor":["Ages 18 Years to any","Patients with a known or suspected malignancy and healthy volunteers 18 years of age and older are eligible","Performance status of ECOG 0, 1, 2, or 3 for admission to this protocol","INCLUSION FOR APHERESIS:","Note: Effective with Amendment CC, participants will no longer be asked to undergo apheresis. This content is being retained for historical reference","Hemoglobin greater than or equal to 10 mg/dL and platelet count \\> 75,000/mm(3)","Weight greater than 25 kg","Prothrombin Time - within normal limits"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,750 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.986Z"},{"nctId":"NCT00039689","title":"Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants","officialTitle":"Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-1 Research Participants","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART). Leukapheresis is necessary to obtain enough cells to delineate the response of B cells to CD4+ T cell help, the CD8 factors associated with suppression of viral replication and normalization of immune function, and natural killer function relative to HIV disease.\n\nStudy participants will be adult (older than 18 years) HIV primary or acutely affected patients (those with a history of exposure to HIV but not yet showing chronic symptoms of HIV disease) and HIV chronically infected patients (those infected with HIV for longer than 12 months or showing other symptoms of HIV disease) who are not receiving HAART at the beginning of the study. The study seeks to enroll 30 primary and 30 chronic patients. Pregnant women will not be enrolled in the study; women who become pregnant will be dropped from the study.\n\nLeukapheresis will be performed on each patient before HAART therapy begins and then three times a year. Each session will take between 1 and 3 hours.\n\nThis longitudinal study will enable researchers to examine the function of certain B cells, natural killer cells, and CD8+ T cells in people who do not have chronic HIV disease and in those who do have the disease and are treated with HAART.\n\n...","conditions":["HIV"],"keywords":["Cellular Immunity","Chronic HIV Infection","Antiretroviral Therapy","Primary HIV Infection","Humoral Immunity","Natural History","HIV Infection","Acute Infection","Treatment Naive"],"interventions":[],"enrollment":750,"startDate":"2002-07-12","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Adult (18 years old or older) with HIV-1.\n  2. Adequate venous access for research blood collection.\n  3. Positive HIV antibody immunoassay and a positive confirmatory HIV test (as defined by current CDC criteria). Tests may be done in our clinic or by an outside provider. For individuals with suspected early HIV-1, the following additional criteria may be used: HIV-1 RNA levels of \\>2,000 copies/ml with a negative result from an HIV antibody immunoassay.\n  4. Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy (ART).\n  5. Blood pressure \\< 180/100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer.\n  6. Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000).\n  7. Willingness and ability to give informed consent including consent for the storage of blood samples and genetic testing.\n  8. Antiretroviral naive, no antiretroviral use in the last six months, or previously enrolled 02-I-0202 participants on whom there are samples stored in the repository.\n\n     1. Participants who acquire HIV-1 while taking ART for pre-exposure prophylaxis will be eligible for enrollment as long as they meet diagnostic criteria for HIV positivity.\n     2. Participants who enroll under another LIR apheresis protocol within the past three months and complete the apheresis within 4 weeks of starting ART will also be eligible for enrollment.\n     3. Participants with limited (no more than 4 weeks before screening visit) recent use of ART may be eligible for study participation if, the opinion of the investigator, the ART usage will not impact the scientific validity of the protocol.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant and / or breastfeeding.\n2. Be currently abusing alcohol or other drugs that potentially could interfere with the participant s compliance or safety.\n3. Have a condition which in the opinion of the investigators would make the participant ineligible for the study.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathleen R Gittens","phone":"(301) 435-8003","email":"kathleen.gittens@nih.gov"},{"name":"Susan L Moir, Ph.D.","phone":"(301) 402-4559","email":"sm221a@nih.gov"}],"primaryOutcomes":["To further investigate differences in the immunologic function of various lymphocyte subsets in PWH who are treated early after transmission of HIV and during the chronic phase of the disease."],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Leukapheresis Procedures to Obtain Plasma and Lymphocytes for Research Studies on Antiretroviral Naive HIV-…","inPlainEnglish":"There is evidence that early and aggressive treatment with antiretroviral drugs can prevent the loss of immune cell function that accompanies HIV infection. This study will use leukapheresis (drawing blood, separating out the white cells and returning the blood to the patient) to obtain blood cells from HIV-infected patients in either the acute or chronic stage of infection who are being treated with early highly active antiretroviral therapy (HAART).","whoItsFor":["Ages 18 Years to 120 Years","Adult (18 years old or older) with HIV-1","Adequate venous access for research blood collection","Willingness to be able to make follow up visits at least once in the next 4 months and prior to the initiation of antiretroviral therapy (ART)","Blood pressure \\< 180/100; pulse rate between 50-100 unless a lower pulse rate is considered normal for the volunteer","Adequate blood counts (hemoglobin greater than or equal to 9.0 g/dL, hematocrit greater than or equal to 28 percent, platelets greaterhan or equal to 50,000)","Antiretroviral who have not tried this kind of treatment before, no antiretroviral use in the last six months, or previously enrolled 02-I-0202 participants on whom there are samples stored in the repository","Participants who acquire HIV-1 while taking ART for pre-exposure prophylaxis will be eligible for enrollment as long as they meet diagnostic criteria for HIV positivity"],"whoShouldSkip":["Pregnant and / or breastfeeding","Be currently abusing alcohol or other drugs that potentially could interfere with the participant s compliance or safety","Have a condition which in the opinion of the investigators would make the participant ineligible for the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 750 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.526Z"},{"nctId":"NCT00050752","title":"Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer","officialTitle":"Hereditary Leiomyomatosis Renal Cell Cancer (HLRCC): Identification of the Disease Gene, and Characterization of the Predisposition to Renal Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle. HLRCC can cause various health problems. Some people develop red bumps on their skin that can be painful at times. Some women with HLRCC can develop leiomyomas of the uterus. In some families, people with HLRCC develop kidney tumors. This study will try to determine:\n\n* What gene changes (mutations) cause HLRCC\n* What kind of kidney tumors develop in HLRCC and how they grow\n* What the chance is that a person with HLRCC will develop a kidney tumor\n\nPeople with known or suspected HLRCC (and their family members of any age) may be eligible for this study. This includes people in families in which one or more members has skin leiomyoma and kidney cancer; skin leiomyoma and uterine leiomyoma; multiple skin leiomyomas; kidney cancer and uterine leiomyomas, or kidney cancer consistent with HLRCC, including, but not limited to, collecting duct or papillary, type II. Candidates will be screened with a physical examination, family history, and, for affected family members, a review of medical records, including pathology slides and computed tomography (CT) or magnetic resonance imaging (MRI) scans.\n\nParticipants will undergo tests and procedures that may include the following:\n\n* Review of medical records, x-rays, and tissue slides\n* Physical examination and family history\n* Skin examination\n* Gynecological examination for women\n* Interviews with a cancer doctor, cancer nurses, kidney surgeon, and genetic counselor\n* Blood tests for:\n\n  1. Genetic research to identify the gene responsible for HLRCC\n  2. Evaluation of liver, kidney, heart, pancreas, and thyroid function\n  3. Complete blood count and clotting profile\n  4. Pregnancy test for pre-menopausal women\n  5. PSA test for prostate cancer in men over age 40\n* CT or MRI scans (for participants 15 years of age and older only)\n* Skin biopsy (surgical removal of a small sample of skin tissue)\n* Cheek swab or mouth rinse to collect cells for genetic analysis\n* Medical photographs of lesions\n* Questionnaire\n\nWhen the tests are completed, participants will discuss the results with a doctor and possibly a genetic nurse or genetic counselor. The genetic findings will not be revealed to participants because their meaning and implications may not yet be understood. Participants may be asked to return to NIH from every 3 months to every 3 years, depending on their condition, for follow-up examinations and tests.","conditions":["Renal Tumor Histology","Cutaneous Leiomyoma","Kidney Cancer"],"keywords":["Renal Cancer","Hereditary Leiomyomatosis","Uterine Fibroid","Cutaneous Leiomyoma","Natural History"],"interventions":[],"enrollment":1350,"startDate":"2003-02-24","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Individuals that meet one or more of the following criteria:\n\n  * Suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:\n\n    * Cutaneous leiomyoma and kidney cancer; or\n    * Cutaneous leiomyoma and uterine leiomyoma; or\n    * Multiple cutaneous leiomyoma; or\n    * Kidney cancer and uterine leiomyomata\n\nOR\n\n--Renal tumor histology consistent with HLRCC including, but not limited to: Collecting Duct and/or Papillary, Type II\n\nOR\n\n--Are a relative (related by blood) of an individual with a confirmed or suspected diagnosis of HLRCC.\n\n* Participants must be \\>= 2 years of age.\n* All participants and parents/guardians, for children younger than 18 years of age, must sign an informed consent document indicating their understanding of the investigational nature and the risks of this study before any protocol related studies are performed.\n\nEXCLUSION CRITERIA:\n\nNone","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah A Nielsen, R.N.","phone":"(240) 760-6247","email":"deborah.nielsen@nih.gov"},{"name":"W. Marston Linehan, M.D.","phone":"(240) 858-3700","email":"linehanm@mail.nih.gov"}],"primaryOutcomes":["Determine the incidence and characteristics of HLRCC-associated fumarate hydratase gene mutations.","Determine the clinical manifestations of HLRCC","Determine if other genes cause HLRCC.","Determine genotype/phenotype correlations.","Define the types and characteristics (including patterns of growth) of renal cancer associated with HLRCC.","Define the risk of developing renal cancer, cutaneous leiomyoma and uterine leiomyoma in this hereditary cancer syndrome."],"hasResults":false,"conditionSlugs":["prostate-cancer","kidney-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Ca…","inPlainEnglish":"This study will investigate what causes hereditary leiomyomatosis renal (kidney) cell cancer, or HLRCC, and how the disease is related to the development of kidney tumors. Leiomyomas are benign (non-cancerous) tumors arising from smooth muscle.","whoItsFor":["Ages 2 Years to any","Individuals that meet one or more of the following criteria:","Suspected or known to have phenotype or genotype suggestive of Hereditary Leiomyomatosis and Renal Cell Cancer Syndrome (HLRCC), such as:","Cutaneous leiomyoma and kidney cancer; or","Cutaneous leiomyoma and uterine leiomyoma; or","Multiple cutaneous leiomyoma; or","Kidney cancer and uterine leiomyomata","Renal tumor histology consistent with HLRCC including, but not limited to: Collecting Duct and/or Papillary, Type II"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,350 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.897Z"},{"nctId":"NCT00060541","title":"Evaluation and Treatment of Neurosurgical Disorders","officialTitle":"Evaluation and Treatment of Neurosurgical Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment. The clinical data and samples generated during standard of care treatment will be collected as part of this study.\n\nStudy Population: Participants 4 years of age and older with neurosurgical-related conditions, who are seeking care from or referred to the Surgical Neurology Branch for evaluation, are eligible for this protocol.\n\nStudy Design: This is an observational study. Participants will receive standard-of-clinical-care evaluation and treatment for their neurosurgical condition. Clinical evaluation may include laboratory and radiological studies designed to aid in diagnosis or differential diagnosis of the participant s condition or to facilitate treatment. The evaluations may take place in the outpatient clinic areas or in the inpatient units. Some participants will receive standard-of-care medical or surgical treatment for their disorder. Clinical data, tissue samples or body fluids obtained during standard of care treatment, may be used for research. Additional genetic testing may be performed on subjects and their blood relatives if a genetic mechanism underlying the neurological disorder is suspected. Patients in this study may choose to consent to skin biopsies for research purposes, in which case they will sign an additional consent document for this research procedure.\n\nOutcome Measures: No additional research outcome measures will be tracked in this study, as this study is collecting data for potential future use. All outcomes will be those of standard clinical evaluation and treatment. A clinical and research database will be kept of patient s diagnosis, progression, and treatment. Clinical database information may be reported or be used in other studies.","conditions":["Neurologic Disorders"],"keywords":["Brain Tumor","Epilepsy","Pituitary Adenoma","Parkinson's Disease","Spinal Cord Tumor","Natural History"],"interventions":[{"type":"PROCEDURE","name":"Laboratory tests"},{"type":"PROCEDURE","name":"Radiological exams"}],"enrollment":5000,"startDate":"2003-06-04","completionDate":null,"sex":"ALL","minAge":"4 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Participants must be age 4 and older.\n  2. Participants must seek care from, or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)\n  3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated\n  4. For minors: a parent or legal guardian who is able to provide consent.\n\n     For immediate blood relatives of subjects having genetic testing only:\n  5. Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only).\n\nEXCLUSION CRITERIA:\n\n1\\. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder\n\n3.c. Participant Inclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)\n\n1. Participants must be age 4 and older.\n2. Participants must seek care from or be referred to the Surgical Neurology Branch for evaluation and management of neurosurgical conditions (such as central nervous system tumors, peripheral nerve tumors, epilepsy, Parkinson s disease, movement disorders, Chiari syndrome, central nervous system malformations, and pain disorders)\n3. For adults: able to provide informed consent or having a legally-authorized representative to provide consent, if incapacitated\n4. For minors: a parent or legal guardian who is able to provide consent.\n5. Be willing to consent for collection of clinical data or biological samples or their cryopreservation\n\n3.D. Participant Exclusion Criteria for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)\n\n1. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder\n2. At the time of enrollment, subjects without an established diagnosis of a wellcharacterized disease entity with validated treatment algorithms. In such cases, proposed resource investment, in the opinion of the investigators, would not contribute to further advancement of knowledge","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Surgical Neurology Branch","phone":"(301) 496-2921","email":"nindsdir-snbrecruiti@ninds.nih.gov"}],"primaryOutcomes":["standard clinical evaluation and treatment"],"hasResults":false,"conditionSlugs":["parkinson","epilepsy"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Laboratory tests for Neurologic Disorders","inPlainEnglish":"Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.","whoItsFor":["Ages 4 Years to 99 Years","Participants must be age 4 and older","For immediate blood relatives of subjects having genetic testing only:","Blood relative of a subject who is suspected to have a genetic mechanism underlying their neurological disorder (for genetic testing only)"],"whoShouldSkip":["1\\. Patients who are unable to undergo evaluation and treatment for a neurosurgical disorder","c. Participant who can join for the cohort with processing of biological samples only (for those subjects who are only having skin biopsies and/or saliva samples)","Participants must be age 4 and older","Be willing to consent for collection of clinical data or biological samples or their cryopreservation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at Bethesda. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.658Z"},{"nctId":"NCT00081523","title":"Natural History of Sickle Cell Disease","officialTitle":"Studies of the Natural History of Sickle Cell Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.","conditions":["Pain Crisis"],"keywords":["Hemoglobin","Acute Chest Syndrome","Treatment Options","Nitric Oxide","Pulmonary Hypertension","Natural History"],"interventions":[],"enrollment":3500,"startDate":"2004-04-29","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Individuals with known or suspected sickle cell disease\n* 2 years of age and older\n* Willing to provide informed consent or appropriate informed consent from parent or legal guardian\n* Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH).\n\nEXCLUSION CRITERIA:\n\n* Patient and/or guardian unable and unwilling to give informed consent or assent.\n* Patients less than 2 years of age.\n\nIndividuals with known or suspected sickle cell disease will meet the inclusion criteria to enroll in this protocol and can undergo study activities. However, if the individual is found not to have sickle cell disease after enrollment, they will be removed from the protocol, and their research samples will be discarded but they will be counted toward the study accrual. The study team will notify the individual about their removal from the study and explain the reason for it. Any necessary regulatory reporting will also be completed.","locations":[{"facility":"Childrens National Health Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban Hospital","city":"Bethesda","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nancy A Asomaning","phone":"(301) 605-0398","email":"nancy.asomaning@nih.gov"}],"primaryOutcomes":["To gather, through clinical experience, information regarding the natural history, co-morbid conditions and outcomes, and complications relating to sickle cell disease and other hemolytic disorders in minority/ethnic patients"],"hasResults":false,"conditionSlugs":["hypertension","sickle-cell"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","bethesda-maryland"],"enrichment":{"headline":"Natural History of Sickle Cell Disease","inPlainEnglish":"This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.","whoItsFor":["Ages 2 Years to 90 Years","Individuals with known or suspected sickle cell disease","2 years of age and older","Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH)"],"whoShouldSkip":["Patients less than 2 years of age"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,500 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.038Z"},{"nctId":"NCT00083512","title":"Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme","officialTitle":"Urinary and Serum VEGF and MMP Levels in Patients Receiving Radiation Therapy for Glioblastoma Multiforme: Prospective Determination of a Predictive Value for Recurrence","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy. Two proteins of particular interest in this study and which may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor) and MMPs (matrix metalloproteinases).\n\nPatients 18 years of age and older with glioblastoma multiforme who are receiving or will receive radiation therapy as part of their medical treatment may be eligible for this study. Candidates are screened with a history and physical examination, blood tests, and magnetic resonance imaging (MRI) of the brain.\n\nParticipants will have blood and urine samples collected before, during and after completion of their radiation treatment. Urine samples are collected in a cup and about 2 tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be requested at different times during treatment and in the 3-year follow-up period.","conditions":["Glioblastoma Multiforme"],"keywords":["Blood","Urine","GBM","Radiation","Natural History","Glioblastoma Multiforme"],"interventions":[],"enrollment":200,"startDate":"2004-06-22","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAge greater than or equal to 18 years.\n\nHistologically confirmed supratentorial Glioblastoma multiforme.\n\nKarnofsky performance \\>60.\n\nPatient must be a candidate for radiotherapy.\n\nAbility of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nPatients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ.\n\nGliadel wafer placement at the time of surgery.\n\nPregnancy because radiation has the potential for teratogenic or abortifacient effects.\n\n\\<TAB\\>\\<TAB\\>","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rukayat O Salau","phone":"(240) 858-3712","email":"rukayat.salau@nih.gov"},{"name":"Kevin A Camphausen, M.D.","phone":"(240) 760-6205","email":"camphauk@mail.nih.gov"}],"primaryOutcomes":["To determine if an increase in urinary VEGF and MMP level, from the end of treatment to a patient's one-month follow-up examination following radiotherapy is predictive of one-year recurrence in patients with Glioblastoma multiforme"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Collection of Blood and Urine Samples in Patients Receiving Radiation Therapy for Glioblastoma Multiforme","inPlainEnglish":"This study will collect blood and urine samples from patients undergoing radiation therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of this treatment on blood cells and certain proteins. The information from this study may help scientists develop new tests to measure radiation exposure and find new ways to treat cancer with radiation, and help determine which kinds of patients or tumors respond better to radiation therapy.","whoItsFor":["Ages 18 Years to 120 Years","Age greater than or equal to 18 years","Histologically confirmed supratentorial Glioblastoma multiforme","Karnofsky performance \\>60","Patient must be a candidate for radiotherapy"],"whoShouldSkip":["Patients with other cancers excluding non-melanomatous skin cancers or carcinoma in situ","Gliadel wafer placement at the time of surgery","Pregnancy because radiation has the potential for teratogenic or abortifacient effects"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.476Z"},{"nctId":"NCT00106925","title":"Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants","officialTitle":"Long-Term Evaluation and Follow Up Care of Patients Treated With Allogeneic Stem Cell Transplants","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.\n\nPatients between 10 and 80 years of age who received a donor stem cell transplant at the NIH Clinical Center under an NHLBI protocol may be eligible for this study. Candidates must have had their first transplant at least 3 years before entering the current study.\n\nParticipants are generally seen in the clinic every 12 months for some or all of the following procedures:\n\n* Periodic physical examinations, eye examinations, and blood and urine tests.\n* Bone marrow aspiration and biopsy: A sample of bone marrow is obtained for microscopic examination. The patient is given local anesthesia or conscious sedation. An area of the hipbone is numbed, a thin needle is inserted through the skin into the bone, and a small amount of marrow is withdrawn.\n* Tissue biopsy: A small piece of tissue or tumor is obtained for microscopic examination. Depending on the site of the biopsy, the tissue may be removed using a cookie cutter-like \"punch\" instrument, a needle, or a knife. The area is numbed and the tissue is removed with the appropriate tool.\n* Imaging tests to visualize organs, tissues, and cellular activity in specific tissues. For these tests, the patient lies on a table that slides into the scanner. They may include the following:\n\n  1. Nuclear scans use a sensitive camera to track a small amount of radioactive material (radioisotope) that is given to the patient by mouth or through a vein. The scan may show abnormal areas of tissue in the bones, liver, spleen, kidney, brain, thyroid, or spine.\n  2. Magnetic resonance imaging (MRI) uses a magnetic field and radio waves to examine small sections of body organs and tissues.\n  3. Computerized tomography (CT) uses x-rays and can be done from different angles to provide a 3-dimensional view of tissues and organs.\n  4. Positron emission tomography (PET) uses a fluid with a radioisotope attached to it to show cellular activity in specific tissues. The fluid is given through a vein and travels to the cells that are most active (like cancer cells), showing if there is an actively growing tumor.\n* Pulmonary (lung) function tests: The patient breathes into a machine that measures the volume of air the person can move into and out of the lungs.\n* Heart function tests may include the following:\n\n  1. Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.\n  2. Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.\n  3. Multiple gated acquisition scan (MUGA) is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.\n\nDisease relapse or progression, or transplant-related problems may be treated with standard medical, radiation, or surgical therapy, or patients may be offered experimental therapy.","conditions":["Graft-versus-leukemia","Graft vs Host Disease","Graft Rejection"],"keywords":["Peripheral Blood Stem Cells","Graft Versus Leukemia/Myeloma","Graft Versus Host Disease","Whole Body Irradiation","Leukemic Relapse","Natural History"],"interventions":[],"enrollment":1000,"startDate":"2005-04-22","completionDate":null,"sex":"ALL","minAge":"7 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA-TRANSPLANT RECIPIENTS:\n\nPatients surviving three years or more from date of first stem cell transplant who have been treated.\n\n-With an experimental allogeneic stem cell transplant on a NHLBI HB protocol\n\nOr\n\n-With a standard of care allogeneic stem cell transplant on an NHLBI protocol\n\nOr\n\n-Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team\n\nAge greater than or equal to 7 years old and age less than or equal to 80\n\nFor adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.\n\nEXCLUSION CRITERIA-STEM CELL TRANSPLANT RECIPIENTS:\n\nNone, all patients meeting the inclusion criteria will be eligible","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bretagne C Cowling, R.N.","phone":"(301) 827-3479","email":"bretagne.cowling@nih.gov"},{"name":"Richard W Childs, M.D.","phone":"(301) 768-9433","email":"childsr@nhlbi.nih.gov"}],"primaryOutcomes":["Assure consistency of care over time for transplant patients such that outcome data can be meaningfully accrued."],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants","inPlainEnglish":"This study will provide follow-up evaluation and care of patients who have undergone allogeneic (donor) stem cell transplantation at the NIH Clinical Center. Patients are monitored for their response to treatment, disease relapse, and later-occurring effects of the transplant.","whoItsFor":["Ages 7 Years to 80 Years","TRANSPLANT RECIPIENTS:","Patients surviving three years or more from date of first stem cell transplant who have been treated","With an experimental allogeneic stem cell transplant on a NHLBI HB protocol","With a standard of care allogeneic stem cell transplant on an NHLBI protocol","Selectively, when the allogenic transplant was conducted outside the NIH, but the subject has a special condition of interest to the research team","Age greater than or equal to 7 years old and age less than or equal to 80"],"whoShouldSkip":["STEM CELL TRANSPLANT RECIPIENTS:","None, all patients meeting the who can join will be eligible"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.494Z"},{"nctId":"NCT00128973","title":"Evaluation of Patients With Immune Function Abnormalities","officialTitle":"Screening and Baseline Assessment of Patients With Abnormalities of Immune Function","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD). The information from this study will be used to establish the pattern and pace of change of the disease and to help develop new treatments. The period of observation and study following enrollment in this study may be for up to one year. In addition these studies may provide the medical information needed to determine eligibility for enrollment in other clinical study protocols and more prolonged follow up.\n\nPatients of any age with abnormal immune function who have recurrent or unusual infections, whose blood tests show evidence of immune dysfunction, or who have GVHD, XSCID, CGD or LAD may be eligible for this study. Patients' parents, siblings, grandparents, children, aunts, uncles and first cousins of any age also may be included. Healthy normal volunteers between 18 and 85 years of age are recruited as controls.\n\nNormal volunteers undergo a physical examination and provide blood, saliva, and urine samples for immune function studies. Patients' family members provide a medical history, have a physical examination, and give blood and urine samples, and possibly a saliva sample. The samples are used for genetic and routine laboratory studies. Investigators may request tissue samples, such as biopsy specimens, previously removed for medical reasons to be sent to NIH for study. Patients undergo the following tests and procedures:\n\n1. Medical history and physical examination.\n2. Blood and urine tests, including analysis for genes involved in immune disorders.\n3. Buccal smear (in some patients) for genetic studies. This involves scraping the lining of the mouth near the cheek.\n4. Specialized tests to evaluate specific conditions in patients who have an immune disorder that might affect lung function, gum infections or eye problems. These may include chest x-ray, CT scan, breathing function test, dental, eye, and hearing examinations.\n5. Follow-up visits of patients with immune problems may occur at 6 months and at one year after the first visit (or more frequently if medically required) to include:\n\n   * Medical history update\n   * Physical examination\n   * Follow-up on abnormal test results and medical treatments initiated at NIH\n   * Collection of blood, saliva, urine, or wound drainage samples for repeat immune function studies\n   * Tissue study of specimens removed for medical reasons at other institutions besides NIH","conditions":["Chronic Granulomatous Disease (CGD)","X-Linked Severe Combined Immune Deficiency (XSCID)","Leukocyte Adhesion Deficiency 1 (LAD)","Graft Versus Host Disease (cGvHD)"],"keywords":["Infection","Genetic","Inherited Disease","Immunity","Chronic","Abnormal Immune Function","Recurrent Infection","Chronic Granulomatous Disease","CGD","X-Linked Severe Combined Immune Deficiency (XSCID)","XSCID","Leukocyte Adhesion Deficiency 1","LAD","Healthy Volunteer","HV"],"interventions":[],"enrollment":3500,"startDate":"2005-09-19","completionDate":null,"sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients:\n\nTo be eligible to participate in this study as a patient, an individual must meet the following criteria:\n\n* Must be 2 years of age to be seen at the Clinical Center as an outpatient and they must not have any active infections. Send-in samples for clinical diagnosis at any age.\n* Have an abnormality of immune function as manifested by:\n\n  * recurrent or unusual infections,\n  * recurrent or chronic inflammation, or\n  * previous laboratory evidence of immune dysfunction.\n* Have a primary physician outside of the NIH.\n\nRelatives of Patient:\n\nTo be eligible to participate in this study as a patient relative, an individual must meet the following criteria:\n\n* Be a biological mother, father, sibling, child, grandparent, aunt, uncle, or first cousin to a patient.\n\n  --Sibling, child, first cousin, aunt, and uncle must be 2 years of age to be seen at the Clinical Center as an outpatient with no active infections, Send-in samples for clinical diagnosis at any age.\n* Be willing to have blood stored for future studies and/or other research purposes.\n\nHealthy Volunteers:\n\nTo be eligible to participate in this study as a healthy volunteer, an individual must meet the following criteria:\n\n* Be a healthy adult of either sex and between age of 18 and 85 years old.\n* Have a hemoglobin count of \\>=11.\n* Weight greater than 110 pounds.\n* Not have a history of intravenous injection drug use.\n* Not have a history of engaging in high-risk activities for exposure to HIV.\n* Be willing to have their blood samples stored for future research and modified to iPS cells.\n\nAdult Subjects Who Lack Capacity to Consent to Research Participation\n\nAdults who are unable to consent are included in this protocol because they are necessary to answer important scientific questions about abnormalities of immune function. For example, CGD patients can develop neurologic deficits leading to cognitive impairment from infections affecting the brain or from genetic mutations associated with CGD, like McLeod Syndrome. Similar cognitive impairments can occur with other primary immunodeficiencies as well. Excluding these participants from this study would limit our ability to understand these disorders, their association with the immune defect, and to develop therapeutic interventions. We will not be enrolling the other cohorts \"Relatives of Patient\" or \"Healthy Volunteers\" who are unable to consent.\n\nEXCLUSION CRITERIA:\n\nPatients and Relatives of Patient:\n\nIn general, there are no strict exclusion criteria for these cohorts. However, the presence of certain types of acquired abnormalities of immunity solely due to HIV, chemotherapeutic agent(s), or an underlying malignancy could be grounds for possible exclusion for a patient or relative of a patient. In the opinion of the investigator, the presence of such disease processes may interfere with evaluation of a co-existing abnormality of immunity that is the subject of study under this protocol. Pregnant females will not be allowed to participate in any procedure that may be dangerous to the pregnancy or the fetus.\n\nHealthy Volunteers (Who are not Relatives):\n\nAn individual who meets any of the following criteria will be excluded from participation as a healthy volunteer in this study:\n\n* Have HIV or viral hepatitis (B or C), or history of viral hepatitis B or C since age 11.\n* Receiving chemotherapeutic agent(s) or have underlying malignancy.\n* Pregnant.\n* Have history of heart, lung, kidney disease, or bleeding disorders.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patricia L Littel, R.N.","phone":"(301) 335-1744","email":"plittel@mail.nih.gov"},{"name":"Harry L Malech, M.D.","phone":"(301) 480-6916","email":"hmalech@nih.gov"}],"primaryOutcomes":["To establish the pattern and pace of change of disease (frequency, distribution, type and extent of infections, inflammatory lesions and abnormalities of immune function) during a period of up to one year baseline assessment.","To establish the extent of organ involvement (infection and/or inflammation) and organ damage or dysfunction resulting from the abnormality of immune function.","To determine genetic linkage and biochemical correlates of the patient s abnormality of immunity by study of first-, second-, or third-degree related family members blood cells (buccal smears instead of blood for genetic studies in some ind...","To characterize the physiologic, biochemical or genetic basis of the abnormality of immunity."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Evaluation of Patients With Immune Function Abnormalities","inPlainEnglish":"This study will evaluate patients with abnormal immune function that results in recurrent or unusual infections or chronic inflammation. This may include inherited conditions, such as X-linked severe combined immunodeficiency (XSCID), chronic granulomatous disease (CGD), and leukocyte adhesion deficiency (LAD), or conditions resulting from outside factors, such as graft-versus-host disease (GVHD).","whoItsFor":["To be eligible to participate in this study as a patient, an individual must meet the following criteria:","Must be 2 years of age to be seen at the Clinical Center as an outpatient and they must not have any active infections. Send-in samples for clinical diagnosis at any age","Have an abnormality of immune function as manifested by:","recurrent or unusual infections,","recurrent or chronic inflammation, or","previous laboratory evidence of immune dysfunction","Have a primary physician outside of the NIH"],"whoShouldSkip":["Patients and Relatives of Patient:","In general, there are no strict"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,500 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.652Z"},{"nctId":"NCT00177268","title":"Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research","officialTitle":"Peripheral Blood, Urine and Skin Sample Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Pittsburgh","sponsorClass":"OTHER","summary":"This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.","conditions":["Cutaneous T-cell Lymphoma","Sezary Syndrome","Mycosis Fungoides","Eczema","Atopic Dermatitis"],"keywords":["Cutaneous T-cell Lymphoma","Sezary Syndrome","Mycosis Fungoides","Blood/tissue banking","eczema","atopic dermatitis"],"interventions":[{"type":"OTHER","name":"Blood draw, skin biopsy or urine collection"}],"enrollment":200,"startDate":"2004-10","completionDate":"2030-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 or older\n* able and willing to provide informed consent\n* diagnosed with CTCL\n* diagnosed with either atopic dermatitis or eczema\n\nExclusion Criteria:\n\n* Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record","locations":[{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Charity L Ruhl, LPN","phone":"4126472013","email":"ruhlcl@upmc.edu"}],"primaryOutcomes":["Proteomics of Cutaneous T-cell lymphoma"],"hasResults":false,"conditionSlugs":["lymphoma","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Blood draw, skin biopsy or urine collection for Cutaneous T-cell Lymphoma","inPlainEnglish":"This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.","whoItsFor":["Ages 18 Years to any","diagnosed with CTCL","diagnosed with either atopic dermatitis or eczema"],"whoShouldSkip":["Lack of CTCL, atopic dermatitis, or eczema diagnosis in medical record"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Pittsburgh. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.818Z"},{"nctId":"NCT00250159","title":"Natural History Study of Patients With Excess Androgen","officialTitle":"Natural History Study of Patients With Excess Androgen","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","sponsorClass":"NIH","summary":"This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood. Too much androgen in adulthood may result in infertility, and women may have excess facial hair, acne and a more male-like appearance. Excess androgen may also affect mood and behavior and possibly the secretion of other hormones, such as insulin. Two genetic diseases that result in early childhood androgen excess are congenital adrenal hyperplasia (CAH) and familial male-limited precocious puberty (FMPP).\n\nPatients with known or suspected CAH due to 21-hydroxylase deficiency, 11- hydroxylase deficiency, or 3-beta-hydroxysteroid dehydrogenase deficiency and males with known or suspected FMPP may be eligible for this study. Patients with both classic and non-classic CAH are eligible, and patients with androgen excess of unknown cause may be eligible.\n\nParticipants undergo the following procedures:\n\n* Medical history and physical examination.\n* Fasting blood tests for analysis of hormones, blood chemistries including blood sugar and cardiovascular risk factors such as lipids.\n* Oral glucose tolerance test for patients with elevated insulin levels. For this test, a catheter (plastic tube) is placed in a vein in the patient's arm. The patient drinks a sugar-containing fluid and blood samples are collected through the catheter at intervals starting with drinking the solution, and then 30, 60 and 120 minutes after drinking the solution.\n* 24-hour urine collection to measure hormone levels in the urine.\n* DNA testing for patients with 21-hydroxylase deficiency to help identify the type of genetic mutation responsible for the disease.\n* X-ray of the left hand to measure bone age in growing children. The x-ray is used to determine how far into puberty the child is and how much growth potential is left in the bones.\n* A pelvic ultrasound in females and testicular ultrasound in males to evaluate the size and development of the gonads (ovaries in females and testes in males).\n* Cognitive and psychological tests, including an IQ test and evaluation of memory, achievement and behavior.\n* Other tests and evaluations based on medical need.\n\nThe schedule for these procedures varies. In a part of the study involving only patients with CAH, growing children are evaluated twice (once in childhood and once after reaching adult height), and adults are evaluated once. In another part of the study involving patients with CAH and FMPP, growing children are seen twice a year, and adults and children who have reached adult height may be seen annually. Additional visits may be scheduled if medically indicated. In this part of the study, females are asked to keep a record of their periods after their first menstrual cycle.","conditions":["Congenital Adrenal Hyperplasia (CAH)","Familial Male-Limited Precocious Puberty (FMPP)"],"keywords":["Congenital Adrenal Hyperplasia (CAH)","Familial Male Precocious Puberty (FMPP)","21-Hydroxylase Deficiency","Adrenal Insufficiency","Natural History","Congenital Adrenal Hyperplasia","CAH","Familial Male Precocious Puberty","FMPP"],"interventions":[],"enrollment":3000,"startDate":"2006-01-02","completionDate":null,"sex":"ALL","minAge":"1 Day","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Males, ages 0 - 99 with known or suspected FMPP or\n  2. Patients (males and females, ages 0 - 99) with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type.\n  3. Patients with excess androgen of unknown etiology or\n  4. Relatives of patients in this protocol.\n\nEXCLUSION CRITERIA:\n\n1. Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no longer be followed on this protocol.\n2. Patients with significant non-endocrine medical conditions.\n3. Females who are pregnant at the time of initial enrollment.","locations":[{"facility":"Medstar Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah P Merke, M.D.","phone":"(301) 496-0718","email":"dmerke@nih.gov"}],"primaryOutcomes":["To elucidate a comprehensive phenotypic profile for patients with CAH and FMPP"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","bethesda-maryland"],"enrichment":{"headline":"Natural History Study of Patients With Excess Androgen","inPlainEnglish":"This study will evaluate and gather information in patients with genetic causes of too much androgen (male-like hormone) in order to better understand the effects of too much androgen and describe problems associated with it. Too much androgen in childhood, if untreated, results in rapid growth and early puberty with early cessation of growth and short stature in adulthood.","whoItsFor":["Ages 1 Day to 99 Years","Males, ages 0 - 99 with known or suspected FMPP or","Patients (males and females, ages 0 - 99) with known or suspected (based on hormonal, clinical and/or genetic testing) CAH of any type","Patients with excess androgen of unknown etiology or","Relatives of patients in this protocol"],"whoShouldSkip":["Females with isolated polycystic ovary syndrome. If, following a diagnostic work-up, a patient is determined to have PCOS as the only cause of her hyperandrogenism; she will no longer be followed on this protocol","Patients with significant non-endocrine medical conditions","Females who are pregnant at the time of initial enrollment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.925Z"},{"nctId":"NCT00280202","title":"Detection of Genetic Markers of Lung Cancer","officialTitle":"Detection of Genetic Markers of Lung Cancer Initiation and Progression","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Pittsburgh","sponsorClass":"OTHER","summary":"The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.","conditions":["Lung Cancer"],"keywords":["Lung cancer","Carcinogenesis","Genomic changes leading to malignant phenotypes in NSCLC.","Simultaneous mutagenesis of epithelial cells.","Chromosomal abnormalities/mutations in bronchial tissues.","Detect micrometastases in histologically neg. lymph nodes"],"interventions":[{"type":"PROCEDURE","name":"Biopsy of the major carinal area"},{"type":"PROCEDURE","name":"Biopsy of abnormal & suspicious areas of the bronchial tree"},{"type":"PROCEDURE","name":"Evaluation of the tumor for DNA mutations"},{"type":"PROCEDURE","name":"Bronchoalveolar Lavage (BAL) for cytokine analysis"},{"type":"PROCEDURE","name":"Correlation of flow cytometric & RT PCR for TNM stage"},{"type":"PROCEDURE","name":"Analysis of lymph nodes"}],"enrollment":6000,"startDate":"1996-06","completionDate":"2050-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy\n* Written informed consent.\n* To be scheduled for a biopsy or surgical resection or have already had a biopsy and/or surgical removal of a lung mass\n\nExclusion Criteria:\n\nNone","locations":[{"facility":"Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arjun Pennathur, MD","phone":"412-647-7555","email":"pennathura@upmc.edu"},{"name":"Julie Ward, BSN","phone":"412-647-8583","email":"wardj@upmc.edu"}],"primaryOutcomes":["The odds ratio for the risk of lung cancer associated with molecular markers"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Biopsy of the major carinal area for Lung Cancer","inPlainEnglish":"The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.","whoItsFor":["Ages 18 Years to any","Histologic confirmation of lung cancer, lung metastases from a primary site other than lung, mesothelioma or a radiographic lesion highly suspicious for malignancy","To be scheduled for a biopsy or surgical resection or have already had a biopsy and/or surgical removal of a lung mass"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 6,000 people at Pittsburgh. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.725Z"},{"nctId":"NCT00381121","title":"University of Michigan \"Nephrology Research BioBank\"","officialTitle":"Michigan Nephrology Research BioBank for Molecular Analysis of Renal Disease \"Nephrology Research BioBank\"","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.","conditions":["Chronic Kidney Disease"],"keywords":["Tissue Biobank","molecular markers","molecular pathways"],"interventions":[],"enrollment":420,"startDate":"2006-09","completionDate":"2030-08","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Men, women and children undergoing kidney and/or pancreas biopsy at the University of Michigan\n\nExclusion Criteria:\n\n* Individuals not willing to provide consent (for prospective biopsy)","locations":[{"facility":"University of Michigan Health System","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chrysta Lienczewsky","phone":"734-764-2924","email":"boridley@med.umich.edu"}],"primaryOutcomes":[],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"University of Michigan \"Nephrology Research BioBank\"","inPlainEnglish":"The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.","whoItsFor":["Men, women and children undergoing kidney and/or pancreas biopsy at the University of Michigan"],"whoShouldSkip":["Individuals not willing to provide consent (for prospective biopsy)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 420 people at Ann Arbor. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.487Z"},{"nctId":"NCT00451022","title":"Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies","officialTitle":"Follow-Up Study of Subjects Previously Enrolled in Immunotherapy Studies Utilizing Gene Transfer or Other Immunotherapeutic Agents","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup. The study does not involve the use of any drug or biologic agent. Participants will undergo an annual health history. Because certain viruses enter into cells and create proteins from the viral genes, the type of vaccine treatment used is referred to gene therapy. The genes expressed by poxviral vectors do not become part of the genetic material left behind. Because gene therapy is a somewhat new technology, a prolonged monitoring of patients' health status is necessary, according to new specific reporting requirements for harmful events in patients who undergo such gene therapy studies. The risk of any long-term negative effects from the gene therapy that patients had received is quite small. Still, it is important that there be updates at least annually. This annual monitoring of health status will extend for 15 years, according to guidelines from the Food and Drug Administration, or for as long as patients are willing to participate.\n\nPatients who received poxviral vectors (vaccinia or fowlpox, or both) at the National Cancer Institute, through a trial affiliated with the Laboratory of Tumor Immunology and Biology, may be eligible for this study.\n\nParticipants will be involved in the following forms of data collection:\n\n* Annual medical history and physical examinations for the first 5 years following the last vaccine.\n* Annual telephone contact during the last 10 years.\n* Health status check, including primary cancer status, secondary malignancies, neurologic disorders, autoimmune disorders, and hematologic disorders.\n* Blood tests for the presence of HIV antibodies.\n* Reporting of medical problems, including information on unexpected hospitalizations and medications.\n\nIf a participant has died, the study will document the cause of death and autopsy information if available.","conditions":["Prostate Cancer","Liver Cancer","Breast Cancer","Colon Cancer","Lung Cancer"],"keywords":["Gene Therapy","Long Term Survivor","Research Specimen","Natural History"],"interventions":[],"enrollment":750,"startDate":"2004-09-13","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Subjects who received poxviral vectors (vaccinia and/or fowlpox) or other vaccines utilizing gene transfer or any other immunotherapeutic agent through GMB, UOB and LTIB affiliated trials at the National Cancer Institute, as well as subjects at extramural sites receiving these agents as part of a multi-site trial. Available stored specimens obtained from NCI participants in GMB, UOB, and LTIB affiliated protocols may be transferred to this protocol for storage and eventual future research use.\n* Subjects must be \\>= 18 years of age.\n\nEXCLUSION CRITERIA:\n\nParticipants unwilling to participate.\n\n(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sheri A McMahon, R.N.","phone":"(240) 760-7968","email":"sheri.mcmahon@nih.gov"},{"name":"Jennifer L Marte","phone":"(301) 496-7214","email":"martej@mail.nih.gov"}],"primaryOutcomes":["To provide a mechanism for adequate follow-up of subjects previously participating in gene transfer or other immunotherapy studies at the National Cancer Institute as required by the U.S. Food and Drug Administration.","To facilitate the continuous usage of stored research specimens collected from subjects under completed and ongoing protocols."],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","liver-cancer","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Follow-Up Study of Subjects Previously Enrolled in Poxviral Vector Gene Transfer Studies","inPlainEnglish":"This study aims to provide long-term follow-up care of patients previously enrolled in a vaccine study that involved poxviral vectors. Vectors are sequences of genetic material that can be used to introduce specific genes into genetic makeup.","whoItsFor":["Ages 18 Years to any","Subjects must be \\>= 18 years of age"],"whoShouldSkip":["(Please note, participants may participate in this protocol and, at the same time, participate in an active treatment or continuing care study.)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 750 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.969Z"},{"nctId":"NCT00542230","title":"Blood Sampling for Research Related to Sickle Cell Disease","officialTitle":"High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease.\n\nVolunteers must be at least 18 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history.\n\nDuring the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant s consent, participants will donate 8 cc (approximately 2 teaspoons) of blood.\n\nBecause repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children.","conditions":["Sickle Cell Trait","Sickle Cell Disease","Sickle Cell Anemia"],"keywords":["Erythrocytes","Drug Screen","Sickle Cell Trait","Sickle Hemoglobin","Sickle Cell Disease","Natural History"],"interventions":[],"enrollment":250,"startDate":"2007-11-07","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Patients with sickle cell trait\n* Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin\n* Healthy volunteers for control experiments\n* Age range: adults greater than or equal to 18 years of age\n\nEXCLUSION CRITERIA:\n\n* Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.\n* As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"William A Eaton, M.D.","phone":"(301) 496-6030","email":"eaton@mail.nih.gov"}],"primaryOutcomes":["To screen large compound libraries for anti-sickling activity, particularly compounds that are already FDA-approved drugs, with the goal of discovering a drug for treating sickle cell disease."],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Blood Sampling for Research Related to Sickle Cell Disease","inPlainEnglish":"This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body.","whoItsFor":["Ages 18 Years to 100 Years","Patients with sickle cell trait","Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin","Healthy volunteers for control experiments","Age range: adults greater than or equal to 18 years of age"],"whoShouldSkip":["Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 250 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.836Z"},{"nctId":"NCT00595491","title":"Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation","officialTitle":"Inflammatory Cellular Trafficking in Asthma in Response to Segmental Allergen Challenge","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Benjamin Medoff","sponsorClass":"OTHER","summary":"Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation. This work is designed to identify airway factors that are responsible for recruiting cells and associate their airway presence with atopy and asthma.","conditions":["Asthma"],"keywords":["Asthma","Inflammation","Allergic","Airway","Challenge","Chemokines"],"interventions":[{"type":"BIOLOGICAL","name":"Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage"}],"enrollment":313,"startDate":"2008-01","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"A. Subjects with Allergic Asthma (AA subjects)\n\nInclusion Criteria:\n\n1. All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value.\n2. All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick test).\n3. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years).\n4. Willing and able to give informed consent.\n5. Expressed the desire to participate in an interview with the principal investigator.\n6. Age between 18 and 50 years.\n\nExclusion Criteria:\n\n1. Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing.\n2. The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks.\n3. Participation in research study involving a drug or biologic during the 30 days prior to the study.\n4. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.\n5. Antihistamines within 7 days of the screening visit.\n6. Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis.\n7. Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit.\n8. Antibiotic use for respiratory disease within 1 month of the characterization visit or a respiratory tract infection within 6 weeks of the bronchoscopy visits.\n9. A history of asthma-related respiratory failure requiring intubation.\n10. Quantitative skin-prick test positive reaction down to an allergen concentration of 0.056 BAU or AU/ml .\n11. Taking beta-adrenergic blocking agents or monoamine oxidase inhibitors.\n12. Subjects with a high possibility of poor compliance with the study.\n13. No history of cigarette smoking within the past 5 years or \\> 10 pack years total.\n14. Having second-hand cigarette smoke exposure or indoor furry pets except in the case of dog, if the subject is not allergic to the dog and the subject has a negative skin test to dog (It is also preferred but not required that dust mite allergic subjects have dust mite-proof encasings on their mattress and pillows.)\n15. Other lung diseases, such as sarcoidosis, bronchiectasis or active lung infection.\n16. Use of Xolair (omalizumab - anti-IgE monoclonal antibody) for 6 months.\n17. Immunotherapy with cat or dust mite extract now or in the past.\n18. Non-English speakers.\n19. History of coagulopathy, thrombocytopenia, pulmonary hypertension, and/or use of anti-coagulants/anti-platelet drugs.\n\nB. Healthy Normal Control Subjects (NC subjects)\n\nNormal control subjects will be individuals who are in good overall health, age and sex matched to the asthmatic group, age 18 - 50 and nonallergic, i.e. entirely negative on the panel of prick skin tests listed in section V (Study Procedures), with no history of allergic rhinitis or asthma, no history of allergic symptoms caused by cats or dust mite allergen exposure, life-long nonsmokers of cigarettes (defined as a lifetime total of less than 5 pack-years and none in 5 years), normal spirometry (i.e. FEV1 and FVC of at least 90% of predicted) and with a methacholine PC20 of \\> 16 mg/ml.\n\nExclusion Criteria:\n\n1. A history of allergy, asthma, nasal or sinus disease.\n2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above.\n\nC. Allergic Nonasthmatic Subjects (ANA subjects)\n\nInclusion Criteria:\n\n1. ANA subjects will have a history of either (a) allergic rhinitis (with one or more of the following symptoms: nasal congestion, sneezing, runny nose, postnasal drainage), (b) allergic conjunctivitis (ocular itching, tearing and/or swelling) or (c) contact allergy associated with cat dander or dust mite and a positive allergy test to the same allergen.\n2. All subjects will have a baseline FEV1 and FVC determined at the characterization visit that is no less than 90 % of the predicted value.\n3. All subjects will have a positive allergy skin prick test to cat dander or dust mite allergen.\n4. All subjects will be in good general health.\n5. Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years and none in 5 years).\n6. Willing and able to give informed consent.\n7. Expressed the desire to participate in an interview with the principal investigator.\n8. Age between 18 and 50 years.\n\nExclusion Criteria:\n\n1. A history of asthma.\n2. Exclusion criteria #1, 3-8 and 10-19 from (A.) above.\n3. A methacholine PC20 \\< 16 mg/ml.","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel L Hamilos, MD","phone":"617-726-5090","email":"dhamilos@partners.org"},{"name":"Benjamin D Medoff, MD","phone":"617-726-6695","email":"bmedoff@partners.org"}],"primaryOutcomes":["airway inflammation"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 1: testing Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage for Asthma","inPlainEnglish":"Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation.","whoItsFor":["Ages 18 Years to 50 Years","A. Subjects with Allergic Asthma (AA subjects)","All subjects will have a baseline FEV1 determined at the characterization visit that is no less than 75 % of the predicted value","All subjects will have a clinical history of allergic symptoms to cat or dust mite allergen and demonstrated skin reactivity (a positive allergen prick test)","Life-long absence of cigarette smoking (defined as a lifetime total of less than 5 pack-years); none in 5 years)","Expressed the desire to participate in an interview with the principal investigator","Age between 18 and 50 years"],"whoShouldSkip":["Women of childbearing potential who are documented to be pregnant (based on Urine beta-HCG testing), are sexually active and not using contraception, are seeking to become pregnant, or who are nursing","The presence of spontaneous asthmatic episode or clinical evidence of upper respiratory tract infection within the previous 6 weeks","Participation in research study involving a drug or biologic during the 30 days prior to the study","Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam","Antihistamines within 7 days of the screening visit","Presence of diabetes mellitus, congestive heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal failure, history of anaphylaxis, or cirrhosis","Use of systemic steroids, increased use of inhaled steroids, beta blockers and MAO inhibitors or a visit for an asthma exacerbation within 1 month of the screening visit"],"whatHappens":"If you join, the listed intervention(s) are Bronchoscopy, Segmental Allergen Challenge, and Broncheoalveolar Lavage. The registry lists allocation as na. Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 313 people at Boston. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.343Z"},{"nctId":"NCT00605878","title":"Studies of Skin Microbes in Healthy People and in People With Skin Conditions","officialTitle":"Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Human Genome Research Institute (NHGRI)","sponsorClass":"NIH","summary":"This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.\n\nHealthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study.\n\nWe also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD.\n\nEligible participants undergo the following tests and procedures:\n\n* Medical family and medication history\n* Skin examination\n* Blood tests (research blood as well as serum IgE, and complete blood count)\n* Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter.\n* Nose swabs to analyze microbes.\n* Patients with eczema may have photographs of their skin taken to help monitor the skin rashes.\n\nParticipants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.","conditions":["Eczema","Atopic Dermatitis"],"keywords":["Skin","Natural History","Microbiome","Bacteria","Atopic Dermatitis (Eczema)","Atopic Dermatitis","Eczema","Health Volunteer","HG"],"interventions":[],"enrollment":530,"startDate":"2008-01-22","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion Criteria for all groups\n\nMust have a primary care professional who will continue standard of care/evaluation in tandem with the protocol to whom information and recommendations can be communicated.\n\nInclusion Criteria for Group 1: Healthy Volunteers\n\nAdult males or females aged 18-50 at time of enrollment.\n\nInclusion Criteria for Group 2: AD patients\n\nA. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24\n\nB. Moderate to severe AD SCORAD greater than or equal to 25(25)\n\nC. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of enrollment to serve as a target site.\n\nInclusion Criteria for Group 3: Healthy (pediatric) Controls\n\nA. Males or females 2-18 years of age.\n\nInclusion Criteria for Groups 4, 5, \\& 6: AD/HIES/WAS/DOCK8 patients\n\nA. Must have mutation-proven diagnosis, with or without eczematous dermatitis.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for all groups:\n\n1. Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants \\< 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.\n2. Any subjects who have cancer, and are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies within the previous 6 months.\n3. Any subject with a history of bone marrow transplant or gene therapy.\n\nExclusion Criteria specific for Group 2: AD patients\n\nA. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to body site sampling. Unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for greater than or equal to 7 days to small areas of skin intended for sampling. (Topical therapies/emollients for AD may be continued to non-adjacent, nontarget sites.)\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nExclusion Criteria specific for Groups 4, 5, \\& 6: HIES/WAS/DOCK8 patients:\n\nA. Unable to remain off topical steroids and emollients for preferably 7 days but at least 24 hours prior to body site sampling.\n\nExclusion Criteria specific for Groups 1 \\& 3: Healthy Volunteers and Healthy (pediatric) Controls:\n\nA. Any subjects with unstable or uncontrolled or chronic medical conditions requiring treatment or hospitalization. Individual determinations will be made at the discretion of the medical investigator.\n\nB. Underlying immunodeficiency, either as primary disease or secondary to treatment.\n\nC. Other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of the cutaneous microbiome. Common transient conditions, such as acne, are permissible.\n\nD. Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals.\n\nE. Subjects with asthma.\n\n5\\. Any female with symptoms and/or serum hormone levels consistent with perimenopause","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Heidi H Kong, M.D.","phone":"(301) 827-2460","email":"niamsderm@nih.gov"}],"primaryOutcomes":["Primary Immunodeficiency","Healthy volunteers"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Studies of Skin Microbes in Healthy People and in People With Skin Conditions","inPlainEnglish":"This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.","whoItsFor":["Ages 2 Years to 100 Years","who can join for all groups","Must have a primary care professional who will continue standard of care/evaluation in tandem with the protocol to whom information and recommendations can be communicated","who can join for Group 1: Healthy Volunteers","Adult males or females aged 18-50 at time of enrollment","who can join for Group 2: AD patients","A. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24","B. Moderate to severe AD SCORAD greater than or equal to 25(25)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 530 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.823Z"},{"nctId":"NCT00789009","title":"Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection","officialTitle":"Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.\n\nPeople 18 years of age and older with suspected or confirmed HIV infection who live in the Washington, D.C., metropolitan area may be eligible for this study. Physician referral is required.\n\nParticipants come to the NIH Clinical Center a minimum of once every 3 to 4 months for evaluation with a physical examination; blood tests for research purposes, safety, immune status and viral load; and response to any treatment they may be receiving. Other procedures, such as a biopsy, are done only as needed for standard medical practice, and informed consent is obtained before any such procedure is done. Treatment offered is consistent with standard medical practice; no experimental treatments are offered under this protocol.","conditions":["HIV"],"keywords":["Opportunistic Infections","AIDS","Natural History"],"interventions":[],"enrollment":600,"startDate":"2008-11-20","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients are subject to selection by the Principal Investigator, and will satisfy all of the following inclusion criteria:\n\n1. HIV-infection as documented by positive HIV ELISA and Western Blot or positive assay for HIV RNA (serum or plasma). Patients may also be included if they have laboratory or clinical evidence suggestive of possible HIV-infection.\n2. Age 18 years or older.\n3. Ability and willingness of subject to understand study requirements and give written informed consent.\n4. Group I patients are required to have a primary care provider outside NIH to manage non-HIV medical problems. Group II patients must have a referring physician or clinic that will continue to manage HIV and non-HIV medical care.\n5. For Group I patients, residence within the greater Washington DC area (approximately within a 100-mile radius of the NIH Bethesda campus) is required.\n\nEXCLUSION CRITERIA:\n\nA prospective study subject will be ineligible for this study if he or she satisfies either of the following criteria:\n\n1. Has active drug or alcohol use or dependence or any other condition that, in the opinion of the investigator, would interfere with adherence to study requirements.\n2. Refuses to allow collection and storage of samples for research purposes.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bryan P Higgins, R.N.","phone":"(301) 761-7395","email":"bryan.higgins@nih.gov"},{"name":"Michael C Sneller, M.D.","phone":"(301) 496-0491","email":"msneller@niaid.nih.gov"}],"primaryOutcomes":["This study will provide a clinically well-characterized cohort of HIV infected individuals to support ongoing clinical and laboratory based NIAID intramural research programs described above."],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Clinical and Immunologic Monitoring of Patients With Known or Suspected HIV Infection","inPlainEnglish":"This study will investigate HIV infection and associated conditions by monitoring infected patients. The study will also serve as a means for recruiting HIV-infected individuals to NIAIDs ongoing clinical and laboratory studies and supporting the institute s infectious disease training program by providing Infectious Disease fellows with ongoing training in the management of HIV infection.","whoItsFor":["Ages 18 Years to any","Patients are subject to selection by the Principal Investigator, and will satisfy all of the following who can join:","HIV-infection as documented by positive HIV ELISA and Western Blot or positive assay for HIV RNA (serum or plasma). Patients may also be included if they have laboratory or clinical evidence suggestive of possible HIV-infection","Age 18 years or older","Group I patients are required to have a primary care provider outside NIH to manage non-HIV medical problems. Group II patients must have a referring physician or clinic that will continue to manage HIV and non-HIV medical care","For Group I patients, residence within the greater Washington DC area (approximately within a 100-mile radius of the NIH Bethesda campus) is required"],"whoShouldSkip":["A prospective study subject will be ineligible for this study if he or she satisfies either of the following criteria:","Has active drug or alcohol use or dependence or any other condition that, in the opinion of the investigator, would interfere with adherence to study requirements","Refuses to allow collection and storage of samples for research purposes"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 600 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.528Z"},{"nctId":"NCT00794352","title":"Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System","officialTitle":"Comprehensive Multimodal Analysis of Patients With Neuroimmunological Diseases of the CNS","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symptoms of immune-related damage to their CNS.\n\nThis study will include two groups of subjects at least 12 years old. Subjects will either have symptoms of immune-related CNS damage, or will be healthy volunteers selected for comparison purposes.\n\nStudy participants will visit the NIH Clinical Center on an outpatient basis for an initial evaluation visit. During the visit, patients will provide a comprehensive medical history and undergo a neurological examination, and will provide blood samples for research purposes. The healthy volunteers will be asked to schedule a return visit for a magnetic resonance imaging (MRI) procedure, and may be asked to undergo other tests requested by the study researchers on an as-needed basis. The group of patients with symptoms of immune-related CNS damage will be asked to undergo a series of tests, including the following:\n\n* MRI procedures, with a minimum of three brain MRIs and one spinal cord MRI taken approximately 4 weeks apart\n* A diagnostic lumbar puncture, performed on an outpatient basis\n* Tests of brain and vision activity\n* Additional blood and tissue samples\n\nPatients with symptoms of immune-related CNS damage may be offered the opportunity to participate in additional followup tests with NIH researchers.","conditions":["Central Nervous System Disease","Multiple Sclerosis"],"keywords":["Inflammation","Multiple Sclerosis","Neuroimmunology","Immune Disorder","Neuroimaging","Natural History","Central Nervous System Disease","Healthy Volunteers","HV"],"interventions":[],"enrollment":2400,"startDate":"2008-10-01","completionDate":null,"sex":"ALL","minAge":"1 Month","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"* PATIENT INCLUSION CRITERIA (FOR IN-PERSON AND TELEMEDICINE SUB-COHORTS):\n\nPresentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or\n\nNeuroimaging evidence of inflammatory and/or demyelinating/dysmyelinating CNS disease\n\nAt least 12 years old at the time of enrollment\n\nWilling to share medical records (including past MRI results) with the study team.\n\nAdults: Able to give informed consent on their own or via a Legally Authorized Representative (LAR) or Durable Power of Attorney (DPA); or Minors: parent or legal guardian able to give consent, with child willing to give assent, if reasonable based on their age and assent capacity\n\nFor in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evaluations\n\nPATIENT EXCLUSION CRITERIA (FOR IN-PERSON AND TELEMEDICINE SUB-COHORTS):\n\nSignificant medical condition that would make participation in research part of evaluation impossible or risky\n\nFor in-person sub-cohort: Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)\n\nUnwilling to consent for collection of biological samples or their cryopreservation\n\nPATIENT INCLUSION CRITERIA FOR PROCESSING OF COLLECTED BIOLOGICAL SAMPLES:\n\nPresentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or\n\nNeuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease\n\nAbility to obtain either direct or surrogate informed consent for sample processing and storage\n\nAged 0+ years\n\nHEALTHY VOLUNTEER (IN PERSON) INCLUSION CRITERIA:\n\nAt least 18 years old at the time of enrollment\n\nVital signs are found within normal range at the time of the screening visit\n\nAble to give informed consent\n\nAble and willing to undergo related research procedures, such as blood draw, LP\n\nHEALTHY VOLUNTEER (IN PERSON) EXCLUSION CRITERIA:\n\nSystemic inflammatory disorder, or inflammatory or non-inflammatory neurological diseases\n\nPrevious or current history of alcohol and substance abuse\n\nMedical contraindications for MRI (e.g. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)\n\nMedical contraindication for LP\n\nPsychological contraindications for MRI (e.g. claustrophobia). This will be assessed at the time the medical history is collected\n\nPregnancy or current breastfeeding\n\nAny contraindications to having study procedures done\n\nHistory of auditory disorder (e.g. hearing impairment, known impaired acoustic reflex, tinnitus)\n\nHEALTHY VOLUNTEER SUB-STUDY TO OBTAIN NORMATIVE DATA FOR THE SMARTPHONE APPS:\n\nBecause this sub-study collects no personal identifiable information (PII), there are no inclusion/exclusion criteria. Participating subjects are self-declared as not having any neurological deficit, which would be the same population that would provide normative data if the apps were freely available via App store.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amir Moghadam Ahmadi, M.D.","phone":"(301) 761-5333","email":"amir.moghadamahmadi@nih.gov"},{"name":"Bibiana Bielekova, M.D.","phone":"(240) 669-2724","email":"bielekovab@mail.nih.gov"}],"primaryOutcomes":["Disease progression as assessed by clinical and MRI criteria.","Definite diagnosis of MS or another disorder."],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Comprehensive Multimodal Analysis of Neuroimmunological Diseases of the Central Nervous System","inPlainEnglish":"Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS).","whoItsFor":["Ages 1 Month to 99 Years","PATIENT (FOR IN-PERSON AND TELEMEDICINE SUB-COHORTS):","Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or","Neuroimaging evidence of inflammatory and/or demyelinating/dysmyelinating CNS disease","At least 12 years old at the time of enrollment","Willing to share medical records (including past MRI results) with the study team","For in-person sub-cohort: Able to undergo the required procedures, including LP, MRI and clinical/functional evaluations"],"whoShouldSkip":["(FOR IN-PERSON AND TELEMEDICINE SUB-COHORTS):","Significant medical condition that would make participation in research part of evaluation impossible or risky","For in-person sub-cohort: Medical contraindications for MRI (i.e. any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed)","Unwilling to consent for collection of biological samples or their cryopreservation","PATIENT who can join FOR PROCESSING OF COLLECTED BIOLOGICAL SAMPLES:","Presentation with a clinical syndrome consistent with immune-mediated CNS disorder and/or","Neuroimaging evidence of inflammatory and/or demyelinating/ dysmyelinating CNS disease"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,400 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.966Z"},{"nctId":"NCT00923221","title":"Collection of Blood From Patients With Prostate Cancer","officialTitle":"Collection of Blood From Patients With Prostate Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\n* It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role.\n* Genes contain the hereditary information that is passed down from parents to children. Although everyone has the same set of genes, individuals can have different forms of the same gene.\n* Differences in genes may explain, at least in part, why some people develop a more aggressive form of prostate cancer than others.\n\nObjectives:\n\n-To obtain blood samples from patients with prostate cancer to try to identify gene differences associated with progression to the androgen independent state.\n\nEligibility:\n\n-All participants participating in NCI prostate cancer protocols.\n\nDesign:\n\n* Participants with prostate cancer are evaluated in the NCI s Medical Oncology Clinic.\n* Blood samples are collected at the initial visit or at follow-up visits.\n* DNA (genetic material) and white blood cells are extracted from these samples to be used for genotyping and establishment of cell lines.\n* Gene variations are correlated with prostate cancer prognosis and prognostic indicators.","conditions":["Cancer Of Prostate","Prostate Cancer","Prostatic Neoplasms","Metastatic Prostate Cancer","Prostate"],"keywords":["Genetic","Prostatic Neoplasms","Genotyping","Venipuncture","Polymorphism","Natural History","Prostate Cancer"],"interventions":[],"enrollment":1000,"startDate":"2007-02-28","completionDate":null,"sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIndividuals 18 years of age and older are eligible.\n\nIndividuals with a diagnosis of prostate cancer are eligible.\n\nEXCLUSION CRITERIA:\n\nChildren are not eligible.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paula A Carter, R.N.","phone":"(240) 858-3191","email":"pcartera@mail.nih.gov"},{"name":"William D Figg, Pharm.D.","phone":"(240) 760-6179","email":"figgw@mail.nih.gov"}],"primaryOutcomes":["Acquisition and longitudinal analysis of genomic DNA, cfDNA, and cfRNA from participants with prostate cancer"],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Collection of Blood From Patients With Prostate Cancer","inPlainEnglish":"Background: * It is not fully understood why prostate cancer in some men becomes androgen-independent (no longer responds to anti-androgen medication), but genetics likely plays an important role. * Genes contain the hereditary information that is passed down from parents to children.","whoItsFor":["Ages 18 Years to any","Men only","Individuals 18 years of age and older are eligible","Individuals with a diagnosis of prostate cancer are eligible"],"whoShouldSkip":["Children are not eligible"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.314Z"},{"nctId":"NCT00923507","title":"Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)","officialTitle":"Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Lymphoplasmacytic Lymphoma (LPL)/Waldenstrom Macroglobulinemia (WM), and Splenic Marginal Zone Lymphoma (SMZL)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background\n\nThe development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.\n\nObjectives\n\nStudy the history of MBL/CLL/SLL/LPL/WM/SMZL in patients prior to and after treatment. Characterize clinical, biologic and molecular events of disease stability and progression of patients enrolled on this protocol.\n\nEligibility:\n\n* Diagnosis of CLL/SLL and on treatment/previously treated/nearing treatment\n* Diagnosis of LPL/WM\n* As of February 5, 2025, patients with MBL and SMZL will no longer be enrolled.\n* Age greater than or equal to 18 years.\n* ECOG performance status of 0-2.\n\nDesign\n\nPatients are typically followed every 6 to 24 months in the clinic and have blood drawn. Patients may be asked to undergo additional testing, including bone marrow biopsy and aspiration, lymph node biopsy, positron emission tomography, and CT and MRI scans. Some of these tests (e.g., blood draw) may be required to monitor CLL/SLL and LPL/WM. Other tests (e.g., lymph node biopsy) may not be clinically indicated, but patients may be asked to undergo these procedures for research purposes.\n\nNo treatment will be administered on this study. If a patients requires treatment for their cancer, available NIH clinical trials and alternative treatment options will be discussed with the patient.","conditions":["Waldenstrom Macroglobulinemia","Lymphoplasmacytic Lymphoma","Monoclonal B-Cell Lymphocytosis","Small Lymphocytic Lymphoma","CLL (Chronic Lymphocytic Leukemia)"],"keywords":["Chronic Lymphocytic Leukemia (CLL)","Monoclonal B Cell Lymphocytosis","Small Lymphocytic Lymphoma (SLL)","Natural History","Leukemia","Lymphoma"],"interventions":[],"enrollment":1000,"startDate":"2008-05-29","completionDate":null,"sex":"ALL","minAge":"18 Years","maxAge":"110 Years","healthyVolunteers":false,"eligibilityRaw":"-INCLUSION CRITERIA:\n\n1. Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group.\n\n   * on treatment or previously treated\n   * requiring or nearing first-line treatment\n\n   OR\n\n   Diagnosis of LPL/WM. LPL is defined as the presence of an intertrabecular pattern of bone marrow infiltration by small lymphocytes showing plasmacytoid/plasma cell differentiation. WM, comprising \\>95% of LPL cases, describes the clinical syndrome of LPL associated with an IgM monoclonal gammopathy of any concentration. The remaining cases may be IgA, IgM, or non-secreting LPL. Immunophenotyping is required for diagnosis\n2. Age greater than or equal to 18 years.\n3. ECOG performance status of 0-2.\n4. Able to comprehend the investigational nature of the protocol and provide informed consent\n\nEXCLUSION CRITERIA:\n\n1\\. None","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yeseul Kim","phone":"(240) 328-8992","email":"yeseul.kim@nih.gov"}],"primaryOutcomes":["Study the natural history of MBL/CLL/SLL in patients prior to the time when their disease requires treatment."],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History Study of Monoclonal B Cell Lymphocytosis (MBL), Chronic Lymphocytic Leukemia/Small Lymphocy…","inPlainEnglish":"Background The development of new technologies now allow scientists to investigate the molecular basis and clinical manifestations of monoclonal B cell lymphocytosis (MBL), chronic lymphocytic leukemia(CLL)/small lymphocytic lymphoma (SLL), lymphoplasmacytic lymphoma (LPL)/Waldenstrom macroglobulinemia (WM), and splenic marginal zone lymphoma (SMZL). Applying these methods in a natural history study can help identify processes involved in disease progression, and possibly lead to the discovery or validation of treatment targets.","whoItsFor":["Ages 18 Years to 110 Years","Diagnosis of CLL/SLL will be made according to the updated criteria of the NCI Working Group","on treatment or previously treated","requiring or nearing first-line treatment","Age greater than or equal to 18 years","how well you can do daily activities (ECOG score) of 0-2"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.804Z"},{"nctId":"NCT01174121","title":"Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Metastatic Cancer","officialTitle":"A Phase II Study Using Short-Term Cultured, Autologous Tumor-Infiltrating Lymphocytes Following a Lymphodepleting Regimen in Metastatic Cancers Plus the Administration of Pembrolizumab","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nThe NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma. Researchers want to know if TIL shrink s tumors in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. In this study, we are selecting a specific subset of white blood cells from the tumor that we think are the most effective in fighting tumors and will use only these cells in making the tumor fighting cells.\n\nObjective:\n\nThe purpose of this study is to see if these specifically selected tumor fighting cells can cause digestive tract, urothelial, breast, or ovarian/endometrial tumors to shrink and to see if this treatment is safe.\n\nEligibility:\n\n\\- Adults age 18-72 with upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial cancer, or glioblastoma refractory to standard chemotherapy.\n\nDesign:\n\nWork up stage: Patients will be seen as an outpatient at the NIH clinical Center and undergo a history and physical examination, scans, x-rays, lab tests, and other tests as needed.\n\nSurgery: If the patients meet all of the requirements for the study they will undergo surgery to remove a tumor that can be used to grow the TIL product.\n\nLeukapheresis: Patients may undergo leukapheresis to obtain additional white blood cells. (Leukapheresis is a common procedure, which removes only the white blood cells from the patient.)\n\nTreatment: Once their cells have grown, the patients will be admitted to the hospital for the conditioning chemotherapy, the TIL cells and aldesleukin. They will stay in the hospital for about 4 weeks for the treatment.\n\nFollow up: Patients will return to the clinic for a physical exam, review of side effects, lab tests, and scans about every 1-3 months for the first year, and then every 6 months to 1 year as long as their tumors are shrinking. Follow up visits will take up to 2 days.","conditions":["Metastatic Colorectal Cancer","Metastatic Pancreatic Cancer","Metastatic Ovarian Cancer","Metastatic Breast Carcinoma","Metastatic Endocrine Tumors/ Neuroendocrine Tumors"],"keywords":["Digestive Tract Cancers","Breast Cancer","Endocrine Tumors","Ovarian/Endometrial Cancer","Genitourinary Cancer"],"interventions":[{"type":"DRUG","name":"Pembrolizumab (Keytruda)"},{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Aldesleukin"},{"type":"BIOLOGICAL","name":"Young TIL"}],"enrollment":332,"startDate":"2010-08-26","completionDate":"2028-12-27","sex":"ALL","minAge":"18 Years","maxAge":"72 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Measurable (per RECIST v1.0 criteria), metastatic cancer of one of the following types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors. Patients must have at least one lesion that is resectable for TIL generation with minimal morbidity, preferentially using minimal invasive laparoscopic or thoracoscopic surgery for removal of superficial tumor deposit.\n* Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology.\n* Refractory to approved standard systemic therapy. Specifically:\n\n  * Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan.\n  * Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent.\n  * Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen.\n* Patients with 3 or fewer brain metastases that are \\< 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for one month after treatment for the patient to be eligible. Patients with surgically resected brain metastases are eligible.\n* Age greater than or equal to 18 years and less than or equal to 72 years.\n* Clinical performance status of ECOG 0 or 1.\n* Patients of both sexes must be willing to practice birth control from the time of enrollment on this study and 12 months after the last dose of combined chemotherapy for individuals of child-bearing potential (IOCBP) and for four months after treatment for individuals that can father children.\n* IOCBP must have a negative pregnancy test be a pregnancy test prior to the start of treatment because of the potentially dangerous effects of the treatment on the fetus.\n\nSerology\n\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune-competence and thus may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for hepatitis B antigen, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then the patient must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n\nHematology\n\n* ANC \\> 1000/mm\\^3 without the support of filgrastim\n* WBC greater than or equal to 2500/mm\\^3\n* Platelet count greater than or equal to 80,000/mm\\^3\n* Hemoglobin \\> 8.0 g/dL. Subjects may be transfused to reach this cut-off.\n\nChemistry\n\n* Serum ALT/AST less than or equal to 5.0 x ULN\n* Serum creatinine less than or equal to 1.5 x ULN\n* Total bilirubin less than or equal to 2.0 mg/dL, except in patients with Gilbert s Syndrome, who must have a total bilirubin \\< 3.0 mg/dL.\n* Patients must have completed any prior systemic therapy at the time of enrollment.\n\nNote: Patients may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to less than or equal to grade 1.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a durable power of attorney.\n* Subjects must be co-enrolled on protocol 03-C-0277.\n\nEXCLUSION CRITERIA:\n\n* Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immunecompetence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to cyclophosphamide, fludarabine, or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select patients with a clinical history prompting cardiac evaluation: last known LVEF less than or equal to 45%.\n* Documented Child-Pugh score of B or C for hepatocellular carcinoma patients with known underlying liver dysfunction.\n* For select patients with a clinical history prompting pulmonary evaluation: known FEV1 less than or equal to 50%.\n* Patients who are receiving any other investigational agents.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI/Surgery Branch Recruitment Center","phone":"(866) 820-4505","email":"IRC@nih.gov"}],"primaryOutcomes":["Response rate"],"hasResults":false,"conditionSlugs":["breast-cancer","colorectal-cancer","pancreatic-cancer","melanoma","ovarian-cancer","glioblastoma","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Pembrolizumab (Keytruda) for Metastatic Colorectal Cancer","inPlainEnglish":"Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient. These cells are called Tumor Infiltrating Lymphocytes, or TIL and we have given this type of treatment to over 200 patients with melanoma.","whoItsFor":["Ages 18 Years to 72 Years","Confirmation of diagnosis of metastatic cancer by the NCI Laboratory of Pathology","Refractory to approved standard systemic therapy. Specifically:","Patients with metastatic colorectal cancer must have received oxaliplatin or irinotecan","Patients with hepatocellular carcinoma must have received sorafenib (Nexavar(R)), since level 1 data support a survival benefit with this agent","Patients with breast and ovarian cancer must be refractory to both first- and second-line treatments and must have received at least one second-line chemotherapy regimen","Age greater than or equal to 18 years and less than or equal to 72 years","Clinical performance status of ECOG 0 or 1"],"whoShouldSkip":["Participants who are pregnant or nursing because of the potentially dangerous effects of the treatment on the fetus or infant","Concurrent systemic steroid therapy","Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses","Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion","Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS)","History of major organ autoimmune disease","Grade 3 or 4 major organ irAEs clinically attributed to anti-PD-1/PD-L1 therapy"],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab (Keytruda), Fludarabine, or Cyclophosphamide. The registry lists allocation as randomized. Background: The NCI Surgery Branch has developed an experimental therapy that involves taking white blood cells from patients' tumors, growing them in the laboratory in large numbers, and then giving the cells back to the patient.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 332 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.970Z"},{"nctId":"NCT01209000","title":"Nephrotic Syndrome Study Network","officialTitle":"Nephrotic Syndrome Study Network Under the Rare Diseases Clinical Research Network","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients.\n\nIn response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium.\n\nThrough this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich.","conditions":["Minimal Change Disease (MCD)","Membranous Nephropathy","Glomerulosclerosis, Focal Segmental"],"keywords":["Focal and Segmental Glomerulosclerosis","Focal & Segmental Glomerulosclerosis","Focal Segmental Glomerulosclerosis","FSGS","Minimal change disease","MCD","Membranous Nephropathy","MN","Nephrotic Syndrome","Neph Syndrome","NEPTUNE","NephCure","Halpin"],"interventions":[{"type":"PROCEDURE","name":"Kidney Biopsy"}],"enrollment":1200,"startDate":"2010-04","completionDate":"2030-12-31","sex":"ALL","minAge":null,"maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Cohort A (biopsy cohort) Inclusion Criteria:\n\nPatients presenting with an incipient clinical diagnosis for FSGS/MCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS/MCD or MN meeting the following inclusion criteria:\n\n* Documented urinary protein excretion ≥1500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit.\n* Scheduled renal biopsy\n\nCohort B (non-biopsy, cNEPTUNE) Inclusion Criteria:\n\n* Age \\<19 years of age\n* Initial presentation with \\<30 days immunosuppression therapy\n* Proteinuria/nephrotic\n\n  * UA\\>2+ and edema OR\n  * UA\\>2+ and serum albumin \\<3 OR\n  * UPC \\> 2g/g and serum albumin \\<3\n\nExclusion Criteria (Cohort A\\&B):\n\n* Prior solid organ transplant\n* A clinical diagnosis of glomerulopathy without diagnostic renal biopsy\n* Clinical, serological or histological evidence of systemic lupus erythematosus (SLE) as defined by the ARA criteria. Patients with membranous in combination with SLE will be excluded because this entity is well defined within the International Society of Nephrology/Renal Pathology Society categories of lupus nephritis, and frequently overlaps with other classification categories of SLE nephritis (68)\n* Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)\n* Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months\n* Unwillingness or inability to give a comprehensive informed consent\n* Unwillingness to comply with study procedures and visit schedule\n* Institutionalized individuals (e.g., prisoners)","locations":[{"facility":"University of Southern California-Children's Hospital","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University School of Medicine","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco Benioff Children's Hospitals","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lundquist Biomedical Research Institute at Harbor UCLA Medical Center","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz School of Medicine","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Miller School of Medicine","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University and Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Stroger Cook County Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Medical Institute","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kidney Disease Section, NIDDK, NIH","city":"Bethesda","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"CS Mott Children's Hospital, University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Medical Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Children's Mercy Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University - St Louis","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cohen Children's Hospital","city":"New Hyde Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellevue Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Veterans Administration","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Levine Children's Hospital","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest School of Medicine","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University Hospital Rainbow Babies & Children's Hospital","city":"Cleveland","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"MetroHealth Hospital at Case Western Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas-Southwestern","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Children's Hospital - Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Research Center","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"York Central Hospital","city":"Richmond Hill","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Scarborough Hospital","city":"Scarborough Village","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Credit Valley Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chrysta C. Lienczewski, BS","phone":"734-615-5021","email":"NEPTUNE-Study@umich.edu"},{"name":"Amanda Williams, BS","phone":"734-615-5017","email":"NEPTUNE-Study@umich.edu"}],"primaryOutcomes":["Event rate of change in urinary protein excretion and renal function.","Rate of change in renal function."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","palo-alto-california","san-francisco-california","torrance-california","aurora-colorado","miami-florida","atlanta-georgia","chicago-illinois","kansas-city-kansas","baltimore-maryland","bethesda-maryland","ann-arbor-michigan","rochester-minnesota","kansas-city-missouri","st-louis-missouri","new-hyde-park-new-york","new-york-new-york","the-bronx-new-york","chapel-hill-north-carolina","charlotte-north-carolina","winston-salem-north-carolina","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","charleston-south-carolina","dallas-texas","houston-texas","seattle-washington","spokane-washington","richmond-hill-canada","scarborough-village-canada","toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: Kidney Biopsy for Minimal Change Disease (MCD)","inPlainEnglish":"Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community.","whoItsFor":["Ages any to 80 Years","Cohort A (biopsy cohort)","Patients presenting with an incipient clinical diagnosis for FSGS/MCD or MN or pediatric participants not previously biopsied, with a clinical diagnosis for FSGS/MCD or MN meeting the following who can join:","Documented urinary protein excretion ≥1500 mg/24 hours or spot protein: creatinine ratio equivalent at the time of diagnosis or within 3 months of the screening/eligibility visit","Scheduled renal biopsy","Cohort B (non-biopsy, cNEPTUNE) who can join:","Age \\<19 years of age","Initial presentation with \\<30 days immunosuppression therapy"],"whoShouldSkip":["Prior solid organ transplant","A clinical diagnosis of glomerulopathy without diagnostic renal biopsy","Clinical or histological evidence of other renal diseases (Alport, Nail Patella, Diabetic Nephropathy, IgA-nephritis, monoclonal gammopathy (multiple myelomas), genito-urinary malformations with vesico-urethral reflux or renal dysplasia)","Known systemic disease diagnosis at time of enrollment with a life expectancy less than 6 months","Unwillingness to comply with study procedures and visit schedule","Institutionalized individuals (e.g., prisoners)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,200 people at 44 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.064Z"},{"nctId":"NCT01246765","title":"National Pregnancy Registry for Psychiatric Medications","officialTitle":"National Pregnancy Registry for Psychiatric Medications","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.","conditions":["Pregnant Women","Psychotropic Drugs"],"keywords":["Pregnancy","Medication use during pregnancy","Psychiatric medications","ADHD","Atypical Antipsychotics","Antidepressants","Sedative Hypnotics"],"interventions":[],"enrollment":5000,"startDate":"2008-11","completionDate":"2033-12","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Pregnant women\n* Age 18-45\n* Subjects will be willing to participate over the phone\n* Subjects will be able to provide informed consent\n\nExclusion Criteria:\n\n* Women who have completed their pregnancy\n* Women who are planning to become pregnant\n* Women who are not taking any psychiatric medications and/or have no history of psychiatric illness","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bryn Rediger","phone":"(617) 724-8020","email":"brediger@partners.org"},{"name":"Lee Cohen, MD","phone":"(617) 724-8020","email":"lcohen2@partners.org"}],"primaryOutcomes":["Major Malformations in Infants"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"National Pregnancy Registry for Psychiatric Medications","inPlainEnglish":"The National Pregnancy Registry for Psychiatric Medications is dedicated to evaluating the safety of psychiatric medications such as antidepressants, ADHD medications, sedative hypnotics, and atypical antipsychotics that many people take during pregnancy to treat a wide range of mood, anxiety, executive function, or psychiatric disorders. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is limited.","whoItsFor":["Ages 18 Years to 45 Years","Women only"],"whoShouldSkip":["Women who have completed their pregnancy","Women who are planning to become pregnant","Women who are not taking any psychiatric medications and/or have no history of psychiatric illness"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.644Z"},{"nctId":"NCT01247597","title":"DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study","officialTitle":"DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\n\\- Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age. Recently, it has been shown that this condition can be inherited (e.g., mutation of the DICER1 gene). Researchers are studying both clinical and genetic aspects of this newly described condition. They are interested in collecting further medical history and genetic information on individuals and close relatives of individuals who have PPB or other rare associated tumors.\n\nObjectives:\n\n\\- To study individuals with a personal or a family history of pleuropulmonary blastoma (PPB) or other rare tumors that can be associated with PPB (e.g., cystic nephroma, nasal chondromesenchymal hamartoma, ovarian Sertoli-Leydig cell tumors, ocular medulloepithelioma).\n\nEligibility:\n\n* Individuals who have been diagnosed with PPB and/or PPB-related tumors.\n* Close blood relatives (e.g., parents, siblings, grandparents) of individuals who have been diagnosed with PPB and/or PPB-related tumors.\n\nDesign:\n\n* Interested participants can enroll or inquire about this study by calling 1-800-518-8474.\n* Participants will be asked to complete family history and medical history questionnaires. They will complete the questionnaire if they are at least 18 years of age, or another person will complete the questionnaire if the key family member is too young to do so on his or her own.\n* Participants will be asked to sign a medical record release form to allow researchers to examine detailed medical history information.\n* Participants may be asked to have a physical examination and imaging studies, provide blood and saliva samples, or provide tumor tissue from prior biopsies or cancer surgeries.\n* Annually, participants will update the family history and individual information questionnaires to document important changes in medical history, and will also update the medical record release form. Participants may be asked to provide additional cheek lining cells and/or blood samples, as well as tumor tissue from any new or planned biopsies or tumor surgeries.\n* Treatment will not be provided as part of this protocol.","conditions":["Pleuropulmonary Blastoma","Cystic Nephroma","Ovarian Sertoli-Leydig Cell Tumors","Ocular Medulloepithelioma","Nasal Chondromesenchymal Hamartoma"],"keywords":["Thyroid Cancer","Germline DICER1 Mutation","MicroRNA Biogenesis","Natural History","Pleuropulmonary Blastoma","PPB"],"interventions":[],"enrollment":1500,"startDate":"2011-02-13","completionDate":null,"sex":"ALL","minAge":"1 Month","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAll participants who meet the eligibility criteria outlined below will be eligible for inclusion in this study regardless of their race, gender, ethnicity, or age.\n\n* Affected individual is defined as:\n\n  * an individual with histologically-confirmed PPB and/or other DICER1-related tumors\n  * an individual with a known or suspected DICER1 disease-associated variant\n  * an individual from the general population with one or more of the unique tumors of the types associated with DICER1 including (but not exclusively), PPB, cystic nephroma, ovarian Sertoli-Leydig cell and other sex cord-stromal tumors, ocular medulloepithelioma, nasal chondromesenchymal hamartoma, Wilms tumor, embryonal rhabdomyosarcoma, pineoblastoma, pituitary blastoma, ovarian sarcoma, CNS sarcoma and/or thyroid cancer - regardless of their family history. Additional DICER1-related neoplasms may be identified in the future, and they will be added to the protocol as needed.\n* Unaffected individual is defined as:\n\n  * a family member (such as parents, siblings, children, or extended family) of an affected participant without a known or suspected DICER1 disease-associated variant or condition and they will be controls.\n\nOther inclusion criteria include:\n\n* All types and amounts of prior therapies are allowed.\n* There is no age restriction.\n* There is no restriction related to organ and marrow function.\n* Ability of the individual or their legal guardian or appropriate surrogate to understand, and their willingness to provide informed consent.\n\nNeonates of affected individuals will be included in the Field Cohort and be eligible for genetic counseling, education, and testing, if indicated and consented by a parent/legal guardian/LAR.\n\nThis is entirely a function of meeting the inclusion criteria and not being excluded by the exclusion criteria.\n\nIn some instances, patients with histologically-confirmed PPB and/or another neoplasm within the DICER1-related tumor risk and their families will be referred to the Clinical Genetics Branch (CGB) by the International Pleuropulmonary Blastoma (PPB) / DICER1 Registry (IPPBR), provided that the family has previously or currently indicated a desire to be notified of such research opportunities. In non IPPBR-cases, the diagnosis will be confirmed by reviewing relevant medical records and relevant surgical pathology material.\n\nEXCLUSION CRITERIA:\n\nIndividuals and families referred for evaluation in whom reported diagnoses are not verifiable.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Institute - Shady Grove","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Family Study Referrals","phone":"(800) 518-8474","email":"ncifamilystudyreferrals@mail.nih.gov"},{"name":"Douglas R Stewart, M.D.","phone":"(240) 276-7238","email":"drstewart@mail.nih.gov"}],"primaryOutcomes":["Psychosocial and Behavioral Issues","Management Guidelines &amp; Risk-reduction Strategies","Genetic &amp; Environmental Interactions","DICER1-Related Pleuropulmonary Blastoma Cancer Predisposition Syndrome","Clinical Phenotype","Biospecimen Repository"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland","rockville-maryland"],"enrichment":{"headline":"DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study","inPlainEnglish":"Background: \\- Pleuropulmonary blastoma (PPB) is a rare fast-growing lung tumor that is associated with other, rare tumor types. Most cases of PPB appear in children younger than 6 years of age.","whoItsFor":["Ages 1 Month to 99 Years","All participants who meet the eligibility criteria outlined below will be eligible for inclusion in this study regardless of their race, gender, ethnicity, or age","Affected individual is defined as:","an individual with histologically-confirmed PPB and/or other DICER1-related tumors","an individual with a known or suspected DICER1 disease-associated variant","Unaffected individual is defined as:","a family member (such as parents, siblings, children, or extended family) of an affected participant without a known or suspected DICER1 disease-associated variant or condition and they will be controls","Other who can join include:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,500 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.160Z"},{"nctId":"NCT01273129","title":"Surgery as a Treatment for Medically Intractable Epilepsy","officialTitle":"Surgery as a Treatment for Medically Intractable Epilepsy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\n\\- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery. The tests and surgery performed as part of this treatment are not experimental, but researchers are interested in using the data collected as part of routine standard epilepsy care to better understand epilepsy and its treatment.\n\nObjectives:\n\n\\- To use surgery as a treatment for drug resistant epilepsy in children and adults.\n\nEligibility:\n\n\\- Children and adults at least 8 years of age who have simple or complex partial seizures (seizures that come from one area of the brain) that have not responded to medication, and who are willing to have brain surgery to treat their medically intractable epilepsy.\n\nDesign:\n\n* Participants will be screened with a medical history, physical examination, and neurological examination. Imaging studies, including magnetic resonance imaging and computer-assisted tomography (CT), may also be conducted as part of the screening. Participants who do not need surgery or whose epilepsy cannot be treated surgically will follow up with a primary care physician or neurologist and will not need to return to the National Institutes of Health for this study.\n* Prior to the surgery, participants will have the following procedures to provide information on the correct surgical approach.\n* Video electroencephalography monitoring to measure brain activity during normal activities within a 24-hour period. Three to four 15-minute breaks are allowed within this period.\n* Electrodes placed directly in the brain or on the surface of the brain to measure brain activities and determine the part of the brain that is responsible for the seizures (seizure focus).\n* Participants will have a surgical procedure at the site of their seizure focus. Brain lesions, abnormal blood vessels, tumors, infections, or other areas of brain abnormality will be either removed or treated in a way that will stop or help prevent the spread of seizures without affecting irreplaceable brain functions, such as the ability to speak, understand, move, feel, or see.\n* Participants will return for outpatient visits and brain imaging studies 2 months, 1 year, and 2 years after surgery.","conditions":["Epilepsy","Epilepsy, Temporal Lobe","Partial Epilepsy"],"keywords":["Neurosurgery","Childhood Epilepsy","Epilepsy","Frontal Lobe Epilepsy","Temporal Lobe Epilepsy","Natural History"],"interventions":[],"enrollment":300,"startDate":"2011-03-21","completionDate":null,"sex":"ALL","minAge":"8 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, candidates must:\n\n1\\. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy.\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded if they:\n\n1\\. Are unable or unwilling to give informed consent, or have a parent able to provide informed consent if a minor, to the research procedures.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Surgical Neurology Branch","phone":"(301) 496-2921","email":"nindsdir-snbrecruiti@ninds.nih.gov"}],"primaryOutcomes":["Descriptive and/or correlational studies"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Surgery as a Treatment for Medically Intractable Epilepsy","inPlainEnglish":"Background: \\- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery.","whoItsFor":["Ages 8 Years to 99 Years","To be eligible for entry into the study, candidates must:","1\\. Be 8 years of age or older with drug resistant epilepsy or tumor related epilepsy"],"whoShouldSkip":["Candidates will be excluded if they:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.917Z"},{"nctId":"NCT01425892","title":"The Pathogenesis and Natural History of Sjogren's Disease","officialTitle":"The Pathogenesis and Natural History of Sjogren's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","sponsorClass":"NIH","summary":"Background:\n\n-Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease.\n\nObjectives:\n\n-To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them.\n\nEligibility:\n\n* Participants must be 16 years of age or older.\n* They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease.\n\nDesign:\n\n* People taking part in the study will come to the NIH Clinical Center for at least three visits.\n* During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis).\n* Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes.\n* The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation.","conditions":["Sjogren's Syndrome","Salivary Gland","Pathogenesis"],"keywords":["Sjogren's Syndrome","Salivary Gland","Pathogenesis","Natural History","Sj(SqrRoot)(Delta)gren s syndrome","Sjogrens Syndrome"],"interventions":[],"enrollment":300,"startDate":"2012-01-18","completionDate":null,"sex":"ALL","minAge":"16 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Ability to sign informed consent form\n  2. Fulfilling one the definitions below:\n\n     1. Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)\n     2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)\n     3. Incomplete SjD\n\n     i. at least 2 of the EA criteria with a common manifestation of SjD not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc) or\n\n     ii. 2 or more common manifestations of SjD which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions\n\n     EXCLUSION CRITERIA:\n\n  <!-- -->\n\n  1. Age \\<16 years\n  2. inability or unwillingness to comply with follow up requirements\n  3. Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)\n  4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eileen M Pelayo","phone":"(301) 594-3097","email":"eileen.pelayo@nih.gov"},{"name":"Zohreh Khavandgar, D.D.S.","phone":"(301) 496-4486","email":"zohreh.khavandgar@nih.gov"}],"primaryOutcomes":["Clinical phenotyping of SjD patients and controls over time Collection of samples for concurrent and future laboratory studies related to the pathogenesis Identification of biomarker candidates in SjD"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"The Pathogenesis and Natural History of Sjogren's Disease","inPlainEnglish":"Background: -Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth.","whoItsFor":["Ages 16 Years to 100 Years","Fulfilling one the definitions below:","Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)","Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)","i. at least 2 of the EA criteria with a common manifestation of SjD not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc) or","ii. 2 or more common manifestations of SjD which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions"],"whoShouldSkip":["inability or unwillingness to comply with follow up requirements","Any medical or psychological/psychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)","NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.953Z"},{"nctId":"NCT01432847","title":"Cell Collection to Study Eye Diseases","officialTitle":"Generation of Induced Pluripotent Stem (iPS) Cell Lines From Somatic Cells of Participants With Eye Diseases and From Somatic Cells of Matched Controls","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\n\\- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases. However, cells collected from hair follicles, skin, saliva, urine, and blood can be used for research. Researchers want to collect cells from people with Best disease, L-ORD, and AMD, and compare their cells with those of healthy volunteers.\n\nObjectives:\n\n\\- To collect hair, skin, saliva, urine, and/or blood samples to study three eye diseases that affect the retina: Best disease, L-ORD, and AMD.\n\nEligibility:\n\n* Individuals affected with ocular condition is one year of age or older.\n* Individuals affected with Best disease, L-ORD, or AMD is 18 years of age or older.\n* Unaffected individuals are seven years of age or older.\n\nDesign:\n\n* The study requires one visit to the National Eye Institute.\n* Participants will be screened with a medical and eye disease history. They may also have an eye exam.\n* Participants will provide a hair sample, saliva sample, urine sample, blood sample, and/or a skin biopsy. The hair will be collected from the back of the head, and the skin will be collected from the inside of the upper arm.","conditions":["Retinal Disease","AMD","Retinal Degeneration","Retinitis Pigmentosa"],"keywords":["Best Disease","Late-Onset Retinal Degeneration (L-ORD)","Age-Related Macular Degeneration (AMD)","Natural History","Retinal Degeneration","Age-Related Macular Degeneration","AMD"],"interventions":[],"enrollment":930,"startDate":"2011-09-07","completionDate":null,"sex":"ALL","minAge":"1 Day","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible, participants must meet the following inclusion criteria.\n\n1. Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children or have a legally authorized representative if they are adults without consent capacity.\n2. Participant meets one of the following criteria:\n\n   1. Participant has been diagnosed with an ocular condition of interest including but not limited to: degenerative retinal diseases, optic atrophy, microphthalmia/anophthalmia, ciliopathy, and other ocular developmental or degenerative conditions.\n   2. Participant is free of eye diseases and could serve as an unaffected control. Participant's age, sex, and ethnicity must match an existing participant with one of the eye diseases under study. Control participants matched to AMD participants must not have drusen greater than 63 microns in size.\n3. Adult participant is able to provide a punch skin biopsy and 30 mL of peripheral venous blood OR child participant is able to provide a punch skin biopsy and the lesser of 5 mL/kg or 30 mL of peripheral venous blood. Healthy, unaffected children will only have one skin punch biopsy done 3mm or less in size. In affected participants, an additional punch may be gathered if the initial sample does not contain adequate cells. This will be taken from children ages seven years and older. Sampling of ten occipital hairs and/or saliva may be pursued at the investigator's discretion. Participants not able to provide a skin biopsy or blood sample may opt to provide 100-200 ml of fresh urine. As a rule, samples will be collected on non-sedated/anesthetized participants. Sedation/anesthesia will NOT be used solely for the purpose of sample collection. In rare instances where a minor requires sedation for another medically indicated procedure, samples may be collected at the time of sedation/anesthesia. Because young children may not be able to cooperate with sample collection, those unable to provide a skin biopsy, urine sample or a blood sample may be excluded from the study, based on the judgment of the examining investigator.\n4. Participant meets one of the following criteria:\n\n   1. Participant affected with an ocular condition is one year of age or older.\n   2. Participant affected with Best disease, L-ORD, or AMD is 18 years of age or older.\n   3. Unaffected participant is seven years of age or older and willing and able to provide assent.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present.\n\n1. Participant is unable to comply with study procedures.\n2. Participant has a systemic disease that, in the opinion of the investigator, compromises the ability to provide adequate samples. Examples of co-existing diseases that would exclude a participant include a bleeding diathesis or a genetic susceptibility to infections, particularly cutaneous infections.\n\nADDITIONAL CRITERIA FOR CLNICAL-GRADE CELL LINE GENERATION:\n\nThe additional eligibility criteria must be met for participants donating samples for the generation of clinical-grade cell lines.\n\nInclusion Criteria\n\n1. Participant must be greater than 18 years of age, as of the date of enrollment. There is no upper age limit for donor enrollment.\n2. Participant is able to provide a punch skin biopsy and 200 ml of peripheral venous blood.\n3. Participant is willing and eligible to co-enroll in NEI protocol 15-EI-0128.\n\nExclusion Criteria\n\n1. Participant has medical history that includes any of the following:\n\n   1. Thrombocytopenia or other blood dyscrasias\n   2. Bleeding diathesis\n   3. Antibiotic use within the prior 48 hours\n   4. Active cancer or history of cancer within the past five years\n   5. History of exposure to transfusion transmitted diseases including HIV and hepatitis B and C as defined by the Standards for Blood\n\n      Banking and Transfusion Services, American Association of Blood Banks.\n   6. Travel to an area where malaria is endemic as defined by the CDC (www.cdc.gov/travel)\n   7. At risk for the possible transmission of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) as described in the FDA Guidance for Industry, January 9, 2002, \"Revised Preventive Measures to Reduce the Possible Risk of Transfusion of Creuzefeldt-Jackob Disease (CJD) and Variant Creuzefeldt-Jackob Disease (vCJD) by Blood and Blood Products\"\n2. Participant is currently febrile (temperature \\> 38 degrees C)\n3. Participant has Hemoglobin level:\n\n   * African American women \\<11.5 grams/dL\n   * Other women \\< 12.0 grams/dL\n   * Men \\<12.5 grams/dL\n4. Participant has low hematocrit (HCT):\n\n   * African American women \\< 34%\n   * Other women \\<36%\n   * Men \\<38%\n5. Participant has Platelets \\<150 x 103/microL\n6. Participant has Absolute neutrophil count \\<1.0 x 103/microL.\n7. Participant has positive tests for blood borne pathogens (as required by the Standards for Blood Banks and Transfusion Services, American Association of Blood Banks. The currently required tests include anti-HIV1/2, anti-HCV, anti-HBc, Anti-HTLV I/II, anti-T. Cruzi, HBsAg, syphilis, and molecular testing for West Nile virus, HCV, HBV, and HIV-1).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nancy Chen","phone":"(301) 435-1831","email":"nancy.chen@nih.gov"},{"name":"Fnu Ruchi, Ph.D.","phone":"(301) 451-3081","email":"fnu.ruchi2@nih.gov"}],"primaryOutcomes":["Discovery of therapeutic interventions for these ocular diseases","The identification of molecular and physiological phenotypes in these cells that may be linked to the onset or progression of the ocular conditions being studied.","The differentiation of iPS cells into RPE, neural retinal cells and/or other ocular cells.","The creation of iPS cells from at least one of the three types of somatic tissues collected from each participant."],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Cell Collection to Study Eye Diseases","inPlainEnglish":"Background: \\- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.","whoItsFor":["Ages 1 Day to 120 Years","To be eligible, participants must meet the following who can join","Participant meets one of the following criteria:","Participant has been diagnosed with an ocular condition of interest including but not limited to: degenerative retinal diseases, optic atrophy, microphthalmia/anophthalmia, ciliopathy, and other ocular developmental or degenerative conditions","Participant affected with an ocular condition is one year of age or older","Participant affected with Best disease, L-ORD, or AMD is 18 years of age or older"],"whoShouldSkip":["A participant is not eligible if any of the following"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 930 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.137Z"},{"nctId":"NCT01496625","title":"National Eye Institute Biorepository for Retinal Diseases","officialTitle":"NEI Intramural Biorepository for Retinal Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\n\\- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time. They also want to study body tissues and blood to understand the nature of eye disease. Studying genes, cells, and tissues may help them understand why some people get eye problems and others do not, or why some people respond to treatment while others do not. Researchers want to collect physical samples and personal data to develop a National Eye Institute database.\n\nObjectives:\n\n\\- To collect health information and blood and tissue samples from people with and without eye diseases, to be used in research studies.\n\nEligibility:\n\n* Individuals at least 2 years of age with different types of eye disease.\n* Healthy volunteers with no history of eye disease.\n\nDesign:\n\n* Participants may be recruited from National Eye Institute studies or may be referred from other sources.\n* Participants will be screened with a physical exam and medical history. They will also have a full eye exam. Questions will be asked about family medical history, especially about eye disease.\n* Blood samples will be collected. Other samples, such as saliva, tears, hair, stool, and urine, may be collected as needed. Adult participants may also provide a skin sample.\n* Tissue or fluid from eye collected as part of eye care or treatment may also be added to the database.\n* No treatment will be provided as part of this study.","conditions":["Age-Related Macular Degeneration","Diabetic Retinopathy","Von Hippel-Lindau Syndrome","Retinal Disease","Retinal Vein Occlusion"],"keywords":["Biological Specimens","Retinal Disease","Diabetic Retinopathy","Phenotype-Genotype correlation","Age-Related Macular Degeneration (AMD)","Natural History","AMD","Healthy Volunteer","HV"],"interventions":[],"enrollment":650,"startDate":"2012-06-18","completionDate":null,"sex":"ALL","minAge":"2 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants will be eligible if they:\n\n* Have the ability to understand and sign an informed consent or have a parent/legal guardian to do so if they are minor children.\n* Manifest diagnosed or undiagnosed retinal disease(s), or could serve as an unaffected control suitable for comparison to participants with various retinal diseases, particularly AMD and diabetic retinopathy (taking into account matching factors such as age and past ocular history).\n\nEXCLUSION CRITERIA:\n\nParticipants will not be eligible if they:\n\n* Are unable or unwilling to give informed consent that includes collection and study of at least one peripheral blood sample.\n* Are unable or unwilling to give informed consent that includes use of NIH medical records and clinical samples for research.\n* Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sheena Jose","phone":"(301) 402-7635","email":"sheena.jose@nih.gov"},{"name":"Tiarnan DL Keenan, M.D.","phone":"(301) 451-6330","email":"tiarnan.keenan@nih.gov"}],"primaryOutcomes":["The intent is to collect data on a variety of phenotypic parameters and to store biospecimens in a manner that permits a broad array of potential testing and experimentation in the future."],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"National Eye Institute Biorepository for Retinal Diseases","inPlainEnglish":"Background: \\- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time.","whoItsFor":["Ages 2 Years to 120 Years","you would be eligible if they:"],"whoShouldSkip":["Participants will not be eligible if they:","Have a systemic disease that compromises the ability to provide adequate ophthalmologic examination or treatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 650 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.149Z"},{"nctId":"NCT01521741","title":"Prospective Screening for Breast Cancer-related Lymphedema","officialTitle":"Prospective Screening for Breast Cancer-related Lymphedema: Analysis of Objective Measurements, Symptoms, Functionality, and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.","conditions":["Lymphedema"],"keywords":["Breast Cancer","Lymphedema","Symptoms","Screening"],"interventions":[{"type":"OTHER","name":"Breast Cancer-Related Lymphedema Screening"}],"enrollment":10000,"startDate":"2009-08","completionDate":"2027-10","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of breast cancer\n* Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)\n\nExclusion Criteria:\n\n* Evidence of distant metastatic disease that may cause edema,\n* Previous breast cancer\n* History of lymphedema\n* Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)\n* Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure).","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Upper extremity changes following treatment for breast cancer"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Breast Cancer-Related Lymphedema Screening for Lymphedema","inPlainEnglish":"The primary objectives of this study are twofold: 1) to detect and determine the level of symptoms, functional disability, and changes in quality of life that breast cancer patients experience from changes in their arms during and after treatment for breast cancer by collecting patient reported outcome measures, objective measurements, and clinical information in a prospectively maintained database and 2) to improve breast cancer-related lymphedema outcomes by early detection using objective measurements and symptoms assessments and assess these outcomes by maintaining the data in a database in order to contribute to the literature. The secondary aim of this study is to assess extracellular fluid content in the upper extremity, breast, and/or trunk of patients treated for breast cancer before, during, and after treatment in order to better understand the role of bioimpedance spectroscopy in lymphedema screening.","whoItsFor":["Ages 18 Years to any","Women only","Confirmed diagnosis of breast cancer","Ability to obtain physical positioning for perometry (e.g. abducting shoulder to 90 degrees) and BIS measurements (e.g. standing without aid)"],"whoShouldSkip":["Evidence of distant metastatic disease that may cause edema,","Previous breast cancer","History of lymphedema","Pregnancy at the time of accrual and/or cardiac implants (contraindications for BIS)","Medical conditions that cause fluid retention or swelling (e.g. axillary cancer recurrence, renal insufficiency, congestive heart failure)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 10,000 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.956Z"},{"nctId":"NCT01581580","title":"Deep Brain Stimulation Surgery for Movement Disorders","officialTitle":"Deep Brain Stimulation Surgery for Movement Disorders","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\n\\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest. It is used to stimulate the areas of the brain that affect movement. Stimulating these areas helps to block the nerve signals that cause abnormal movements. Researchers also want to record the brain function of people with movement disorders during the surgery.\n\nObjectives:\n\n* To study how DBS surgery affects Parkinson s disease, dystonia, and tremor.\n* To obtain information on brain and nerve cell function during DBS surgery.\n\nEligibility:\n\n\\- People at least 18 years of age who have movement disorders, like Parkinson's disease, essential tremor, and dystonia.\n\nDesign:\n\n* Researchers will screen patients with physical and neurological exams to decide whether they can have the surgery. Patients will also have a medical history, blood tests, imaging studies, and other tests. Before the surgery, participants will practice movement and memory tests.\n* During surgery, the stimulator will be placed to provide the right amount of stimulation for the brain. Patients will perform the movement and memory tests that they practiced earlier.\n* After surgery, participants will recover in the hospital. They will have a followup visit within 4 weeks to turn on and adjust the stimulator. The stimulator has to be programmed and adjusted over weeks to months to find the best settings.\n* Participants will return for followup visits at 1, 2, and 3 months after surgery. Researchers will test their movement, memory, and general quality of life. Each visit will last about 2 hours.","conditions":["Parkinson's Disease","Essential Tremor","Dystonia"],"keywords":["Parkinson's Disease","Deep Brain Stimulation","Neurophysiology","Movement Disorder","Dystonia","Parkinson Disease","Essential Tremor"],"interventions":[{"type":"DEVICE","name":"Medtronic Activa Tremor Control System"},{"type":"PROCEDURE","name":"Deep Brain Stimulation"}],"enrollment":200,"startDate":"2011-08-17","completionDate":"2029-12-01","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, candidates must meet all the following criteria:\n\nBe 18 years of age or older.\n\nAble to provide informed consent.\n\nHave a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:\n\n* idiopathic PD not adequately controlled with medication or\n* primary dystonia that is medically refractory, or\n* ET that is not adequately controlled by medications or constitutes a significant functional disability.\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded if they:\n\nAre unable or unwilling to give informed consent to the research procedures.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sharon C Park","phone":"(301) 496-2921","email":"sharon.park@nih.gov"}],"primaryOutcomes":["physiology and efficacy of DBS surgery for movement disorders"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Medtronic Activa Tremor Control System for Parkinson's Disease","inPlainEnglish":"Background: \\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.","whoItsFor":["Ages 18 Years to 99 Years","To be eligible for entry into the study, candidates must meet all the following criteria:","Be 18 years of age or older","Have a clinical diagnosis of one of the following as confirmed by the NIH movement disorders clinic team and the multi-disciplinary DBS surgical conference, and deemed as appropriate for the use of Deep Brain Stimulation therapy:","idiopathic PD not adequately controlled with medication or","primary dystonia that is medically refractory, or","ET that is not adequately controlled by medications or constitutes a significant functional disability"],"whoShouldSkip":["Candidates will be excluded if they:"],"whatHappens":"If you join, the listed intervention(s) are Medtronic Activa Tremor Control System, or Deep Brain Stimulation. The registry lists allocation as na. Background: \\- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Bethesda. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.661Z"},{"nctId":"NCT01631617","title":"Effects of Treatments on Atopic Dermatitis","officialTitle":"Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","sponsorClass":"NIH","summary":"Background:\n\n\\- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin.\n\nObjectives:\n\n\\- To study the effect of eczema treatments on skin bacteria.\n\nEligibility:\n\n* Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis.\n* Healthy volunteers between 18 and 40 years of age with no history of eczema.\n\nDesign:\n\n* Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed.\n* All participants will be assigned to one of several study groups.\n* Healthy volunteers must not have taken antibiotics in the year before the start of the study.\n* All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits.\n* Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.","conditions":["Eczema","Dermatitis","Skin Diseases, Genetic","Dermatitis, Atopic","Skin Diseases"],"keywords":["Investigator-Blinded","Skin Biopsy","Randomized","Antibiotics","Topical"],"interventions":[{"type":"DRUG","name":"Trimethoprim/sulfamethoxazole (TMP/SMZ)"},{"type":"DRUG","name":"Cephalexin"},{"type":"DRUG","name":"Doxycycline"},{"type":"OTHER","name":"Sodium hypochlorite"},{"type":"OTHER","name":"Placebo capsules"},{"type":"OTHER","name":"Placebo Sodium hypochlorite"}],"enrollment":130,"startDate":"2012-09-18","completionDate":"2027-01-01","sex":"ALL","minAge":"2 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\], 2 \\[INACTIVE\\], 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Males and females aged 18-50 years at time of initial protocol sampling\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Ability of subject to understand and provide written informed consent\n* Access to bathing facilities (Cohort 2 \\[INACTIVE\\])\n* Ability to swallow capsules or tablets\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Subjects must be aged 2-50 years\n* Subjects must be co-enrolled in NIH protocol 08-HG-0059\n* Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis\n* Subjects must have a primary care provider\n* Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe\n* Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules)\n* Access to bathing facilities\n* All subjects and/or their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with\n\nthe procedures of the protocol and provide informed consent. Pediatric patients will be included in age appropriate discussions and\n\nage appropriate assent will be obtained in accordance with NIH guidelines.\n\n-Ability of subject to understand and provide written informed consent\n\nCohort 6: Healthy Volunteers\n\n* Subjects previously enrolled in Cohorts 1 \\[NO FURTHER ACCRUAL\\] and 4 \\[INACTIVE\\] who completed on-protocol antibiotic regimen\n* Subjects must participate fully and be willing to comply with the procedures of the protocol\n* Ability of subject to understand and provide written informed consent\n\nEXCLUSION CRITERIA:\n\nCohorts 1 \\[NO FURTHER ACCRUAL\\] and 2 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergy or sensitivity to sodium hypochlorite (NaOCl)\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients\n\n* Does not meet inclusion criteria\n* Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause\n* Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine\n* Family history of toxic epidermal necrolysis\n* Known allergic reaction to sodium hypochlorite (NaOCl)\n* Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling\n* Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling\n* Use of topical or oral CAM agents within 4 weeks of initiation of treatment\n* Subjects with known primary or acquired immunodeficiency\n* Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating treatment on this protocol\n* Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months\n* Pregnancy or lactating\n\nCohorts 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause\n* Use of systemic antibiotics in 12 months preceding baseline sampling\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling\n* Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment\n* (Cohort 4 \\[NO FURTHER ACCRUAL\\]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine\n* (Cohort 5 \\[INACTIVE\\]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine\n* Family history of toxic epidermal necrolysis\n* History of AD or asthma\n* Inability to comply with the requirements of the protocol\n* Pregnant or lactating\n* Subjects with a primary or acquired immunodeficiency, including HIV seropositivity\n* Any chronic past or present medical illness, including chronic skin diseases like psoriasis\n* Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants\n* Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals\n\nCohort 6: Healthy Volunteers\n\n* Does not meet inclusion criteria\n* Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling\n* Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling\n* Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1 through 11.5. Females of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Lactating mothers will discontinue breastfeeding prior to study enrollment.\n* Smokers and subjects who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Heidi H Kong, M.D.","phone":"(301) 827-2460","email":"NIAMSderm@nih.gov"}],"primaryOutcomes":["Characterize microbiome alterations"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Trimethoprim/sulfamethoxazole (TMP/SMZ) for Eczema","inPlainEnglish":"Background: \\- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.","whoItsFor":["Ages 2 Years to 50 Years","Cohorts 1 \\[NO FURTHER ACCRUAL\\], 2 \\[INACTIVE\\], 4 \\[NO FURTHER ACCRUAL\\] and 5 \\[INACTIVE\\]: Healthy Volunteers","Males and females aged 18-50 years at time of initial protocol sampling","Subjects must be co-enrolled in NIH protocol 08-HG-0059","Access to bathing facilities (Cohort 2 \\[INACTIVE\\])","Ability to swallow capsules or tablets","Cohort 3 \\[INACTIVE\\]: Atopic Dermatitis Patients","Subjects must be aged 2-50 years"],"whoShouldSkip":["Cohorts 1 \\[NO FURTHER ACCRUAL\\] and 2 \\[INACTIVE\\]: Healthy Volunteers","Does not meet who can join","Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause","Use of systemic antibiotics in 12 months preceding baseline sampling","Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling","Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment","Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine"],"whatHappens":"If you join, the listed intervention(s) are Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin, or Doxycycline. The registry lists allocation as randomized. Background: \\- Atopic dermatitis, or eczema, is a chronic skin disorder.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 130 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.815Z"},{"nctId":"NCT01730092","title":"Natural History Study of Biomarkers in Pulmonary Arterial Hypertension","officialTitle":"A Natural History Study of Novel Biomarkers in Pulmonary Arterial Hypertension","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institutes of Health Clinical Center (CC)","sponsorClass":"NIH","summary":"Background:\n\n\\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause. Researchers want to follow the natural history of all PAH patients to understand how PAH progresses in order to discover targets for future research into new treatments. To further identify treatment targets, they will compare healthy volunteers to patients with PAH.\n\nObjectives:\n\n\\- To study the natural history of PAH.\n\nEligibility:\n\n* Individuals at least 18 years of age who have PAH.\n* Healthy volunteers at least 18 years of age.\n\nDesign:\n\n* Participants with PAH will have periodic visits to the National Institutes of Health Clinical Center. After the first visit, they will return in 6 months and then yearly or every other year for as long as the study continues.\n* The first visit will take up to 3 days. It will involve the following tests:\n* Physical exam and medical history\n* Blood and urine samples\n* Heart and lung function tests and imaging studies\n* Six-minute walk test\n* Questions about exercise and physical activity\n* Healthy volunteers will have only one visit to the Clinical Center, during which they will undergo screening tests, and complete many of the same tests as patients with PAH","conditions":["Pulmonary Disease","Pulmonary Hypertension"],"keywords":["Vascular Inflammation","Microarray","Right Ventricular Function","Endothelial Dysfunction","Magnetic Resonance Imaging","Natural History"],"interventions":[],"enrollment":270,"startDate":"2013-07-15","completionDate":"2030-12-31","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* ELIGIBILITY:\n\nThe study will enroll subjects with confirmed and suspected NYHA/WHO Group 1 PH (68) as well as age and sex matched control subjects. Subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. There is no exclusion based on race or sex.\n\nINCLUSION AND EXCLUSION CRITERIA FOR PAH SUBJECTS:\n\nInclusion Criteria:\n\nThe following parameters on RHC are required to meet the hemodynamic definition of PAH (NYHA/WHO Group I PH):\n\n* mean pulmonary artery pressure of \\> 25 mmHg at rest,\n* pulmonary capillary wedge pressure of \\< 15 mmHg (or a left ventricular end-diastolic pressure of \\< 12 mmHg), and\n* pulmonary vascular resistance of \\> 3 Wood units (240 dyn s cm-5).\n\nFor patients with suspected PAH (Group I PH) who have not undergone a RHC and/or additional testing to confirm the diagnosis, this testing will be completed as clinically indicated under a procedural consent. If clinically indicated (diagnostic) testing indicates that the subject with suspected PAH does not in fact meet standard criteria for PAH (Group I PH), then the subject will be removed from the study.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women (all women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Age less than 18 years\n* Inability to provide informed written consent for participation in the study\n\nINCLUSION AND EXCLUSION CRITERIA FOR HEALTHY CONTROL SUBJECTS:\n\nInclusion Criteria for Control Subjects\n\nAny healthy man or woman who is the appropriate age and sex for matching to a PAH patient\n\n* Must be eligible for MRI and Gadolinium Based MRI studies\n* Must be eligible for CT and Iodine Based Contrast CT studies\n\nExclusion Criteria for Healthy Control Subjects\n\n* Current pregnancy or breastfeeding (All women of childbearing potential will be required to have a screening urine or blood pregnancy test)\n* Electrocardiographic evidence of clinically relevant heart disease\n* Symptoms of coronary or cardiac insufficiency\n* More than one major risk factor for coronary artery disease (excluding age and sex)\n* Obesity (defined as a body mass index \\> 30 kg/m\\^2)\n* History of underlying conditions/risk factors associated with pulmonary hypertension such as collagen vascular disease, HIV infection, use of appetite suppressants, chronic liver disease or cirrhosis of the liver, chronic thromboembolic disease, congenital heart defects, hypoxemia and/or significant pulmonary parenchymal disease\n* Systemic hypertension that is not well controlled (i.e. blood pressure at the time of screening \\>140/90 mmHg in adults \\< 60 years old or \\>150/90 mmHg in adults 60 years or older) on medications. Subjects taking \\> 2 anti-hypertensive medications will be excluded irrespective of their current blood pressure at time of screening\n* Anemia, thrombocytopenia or coagulopathy\n* Renal insufficiency (defined as an estimated glomerular filtration rate of \\< 60 mL/min/1.73m\\^2 of body surface area)\n* Active tobacco use (\\> 6 months) in the past ten years, any tobacco use within 3 months prior to the screening evaluation or any tobacco use prior to completion of the study\n* Inability to provide informed written consent for participation in the study\n* History of recreational drug use with the exception of marijuana (as long as marijuana use was \\> 3 months from the time of study screening).\n\n  * Volunteers may be excluded if in the opinion of the study investigators they have a condition that may adversely affect the outcome of the study or the safety of the volunteer.\n\nExclusion Criteria for MRI in Healthy Control Subjects and Subjects with PAH\n\nThese contraindications include but are not limited to the following devices or conditions:\n\n1. Implanted cardiac pacemaker or defibrillator\n2. Cochlear Implants\n3. Ocular foreign body (e.g. metal shavings)\n4. Embedded shrapnel fragments\n5. Central nervous system aneurysm clips\n6. Implanted neural stimulator\n7. Any implanted device that is incompatible with MRI\n8. Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and severe dyspnea at rest\n9. Subjects requiring monitored sedation for MRI studies\n10. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.)\n11. Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.\n\nExclusion Criteria for Gadolinium Based MRI Studies Only:\n\n1. History of severe allergic reaction to gadolinium contrast agents despite pre- medication with diphenhydramine and prednisone\n2. Chronic kidney disease (an estimated glomerular filtration rate of \\< 60 mL/min/1.73m\\^2 of body surface area)\n\nExclusion Criteria for Cardiac Computed Tomography in Healthy Control Subjects and Subjects with PAH:\n\n1\\) Subjects with a condition precluding entry into the scanner (e.g. morbid\n\nobesity, claustrophobia, etc.)\n\nExclusion Criteria for Iodine Based Contrast CTA Studies Only:\n\n1. Serum creatinine \\> 1.4 mg/dL\n2. History of multiple myeloma\n3. Use of metformin-containing products less than 24 hours prior to contrast administration\n4. History of significant allergic reaction to CTA contrast agents despite pre-medication with diphenhydramine and prednisone","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Grace M Graninger, R.N.","phone":"(301) 496-9320","email":"ggraninger@cc.nih.gov"},{"name":"Michael A Solomon, M.D.","phone":"(301) 496-9320","email":"msolomon@cc.nih.gov"}],"primaryOutcomes":["Examine whether any novel test (inflammatory markers or high resolution cardiac MRI), accurately classifies PAH subjects according to disease severity as assessed by their baseline 6-minute walk distance."],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History Study of Biomarkers in Pulmonary Arterial Hypertension","inPlainEnglish":"Background: \\- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.","whoItsFor":["Ages 18 Years to 100 Years"],"whoShouldSkip":["who can join:","The following parameters on RHC are required to meet the hemodynamic definition of PAH (NYHA/WHO Group I PH):","mean pulmonary artery pressure of \\> 25 mmHg at rest,","pulmonary capillary wedge pressure of \\< 15 mmHg (or a left ventricular end-diastolic pressure of \\< 12 mmHg), and","pulmonary vascular resistance of \\> 3 Wood units (240 dyn s cm-5)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 270 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.037Z"},{"nctId":"NCT01776398","title":"Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies","officialTitle":"Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Weill Medical College of Cornell University","sponsorClass":"OTHER","summary":"The purpose of this study is to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters. These provide control information when compared to individuals with various pulmonary diseases, and will help in understanding of the etiology and pathogenesis of various lung diseases. The underlying hypothesis is that the pathologic morphological changes in the airway epithelium must be preceded by changes in the gene expression pattern of the airway epithelium and potentially in macrophages.","conditions":["Chronic Obstructive Pulmonary Disease (COPD)","Smoking","Smoking Cessation","Idiopathic Pulmonary Fibrosis (IPF)","Rheumatoid Arthritis-Associated Interstitial Lung Disease","Scleroderma-Associated Interstitial Lung Disease (SSC-ILD)"],"keywords":["COPD","Chronic Obstructive Pulmonary Disease","Lung disease","Emphysema","Smoking","Healthy Smoker","Smoker","Non-smoker","IPF","RA-ILD","SSC-ILD","Idiopathic Pulmonary Fibrosis","Rheumatoid Arthritis-Associated Interstitial Lung Disease","Scleroderma-Associated Interstitial Lung Disease"],"interventions":[],"enrollment":2000,"startDate":"2012-08-29","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS (Healthy as defined by those not having lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* All study subjects should be able to provide informed consent\n* Males or females ages 18 years and older\n* Must provide HIV informed consent\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE (As defined by those having lung disease or symptoms of lung disease and inclusive of: all races, ethnicities, sex, HIV status, smoking status and multiple birth status, etc., within the general population. Smoking status is defined for individuals that may use any of the following: cigarettes, pipes, E-cigarettes, waterpipe, shisha, etc.):\n\n* Must provide informed consent\n* Males and females age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and/or (6) diseases of organs with known association with lung disease\n* Must provide HIV informed consent\n\nAdditional Inclusion criteria for CF subjects:\n\n• All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50%\n\nGroup 2 - WCMC/NYPH CLINICAL PATIENTS\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: (1) symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; (6) diseases of organs with known association with lung disease, and (7) individuals with the blood eosinophil levels of 5% or greater.\n\nGroup 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Must provide informed consent\n* Males and females, age 18 years and older\n* Lung disease proven by at least one of the following: symptoms consistent with pulmonary disease; (2) chest X-rays consistent with lung disease; (3) pulmonary function tests consistent with lung disease; (4) lung biopsy consistent with lung disease; (5) family history of lung disease; and (6) diseases of organs with known association with lung disease\n\nExclusion Criteria:\n\nGroup 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS\n\n* Individuals not deemed in good overall health by the investigator during screening visits and/or prior to the bronchoscopy will not be accepted into the study.\n* Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study.\n* Individuals with allergies to atropine or any local anesthetic will not be accepted into the study.\n* Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study.\n* Females who are pregnant or nursing will not be accepted into the study\n\nGroup 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE\n\n* Any history of allergies to xylocaine, lidocaine, versed, valium, atropine, pilocarpine, isoproterenol, terbutaline, aminophylline, or any local anesthetic will not be included in the study\n* Individuals deemed unable to complete the bronchoscopy due to health concerns by the investigator.\n* Females who are pregnant or nursing\n\nAdditional Exclusion criteria for CF subjects:\n\n* Experienced a recent (≤ 8 weeks) pulmonary exacerbation of their disease\n\nGroup 2 - WCMC/NYPH CLINICAL PATIENTS\n\n* Patient refuses consent\n\nGroup 3 - PCNY CLINICAL PATIENTS\n\n* Patient refuses consent","locations":[{"facility":"Weill Cornell Medical College and Weill Cornell Medical Center, Department of Genetic Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Niamh Savage","phone":"12127460284","email":"nis2049@med.cornell.edu"}],"primaryOutcomes":["Establishing normal ranges for various parameters"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis","copd"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies","inPlainEnglish":"This study wants to obtain biologic materials from the blood, airways and/or urine of normal individuals and individuals with lung disease. The normal are used to establish a set of normal ranges for various parameters.","whoItsFor":["Ages 18 Years to any","Males or females ages 18 years and older","Males and females age 18 years and older","Additional who can join for CF subjects:","All CF subjects will be homozygous for the ΔF508 mutation, with mild-moderate lung disease as defined by FEV1 ≥ 50%","Group 2 - WCMC/NYPH CLINICAL PATIENTS","Males and females, age 18 years and older","Group 3 - PCNY CLINICAL PATIENTS VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE"],"whoShouldSkip":["Group 1.1 - HEALTHY VOLUNTEER RESEARCH SUBJECTS","Individuals not deemed in good overall health by the investigator during screening visits and/or prior to the bronchoscopy will not be accepted into the study","Individuals with history of chronic lung disease, including asthma or with recurrent or recent (within three months) acute pulmonary disease will not be accepted into the study","Individuals with allergies to atropine or any local anesthetic will not be accepted into the study","Individuals with allergies to pilocarpine, isoproterenol, terbutaline, atropine or aminophylline will not be accepted into the study","Females who are pregnant or nursing will not be accepted into the study","Group 1.2 - VOLUNTEER RESEARCH SUBJECTS WITH LUNG DISEASE"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at New York. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.963Z"},{"nctId":"NCT01793168","title":"Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford","officialTitle":"Coordination of Rare Diseases at Sanford","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanford Health","sponsorClass":"OTHER","summary":"The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts. Through partnerships with patient advocacy organizations and researchers worldwide, CoRDS helps connect rare disease communities with research opportunities while advancing knowledge across more than 7,000 rare diseases. Participation is free of charge.","conditions":["Rare Disorders","Undiagnosed Disorders","Disorders of Unknown Prevalence","Cornelia De Lange Syndrome","Prenatal Benign Hypophosphatasia","Perinatal Lethal Hypophosphatasia","Odontohypophosphatasia","Adult Hypophosphatasia","Childhood-onset Hypophosphatasia","Infantile Hypophosphatasia","Hypophosphatasia","Kabuki Syndrome","Bohring-Opitz Syndrome","Narcolepsy Without Cataplexy","Narcolepsy-cataplexy","Hypersomnolence Disorder","Idiopathic Hypersomnia Without Long Sleep Time","Idiopathic Hypersomnia With Long Sleep Time","Idiopathic Hypersomnia","Kleine-Levin Syndrome","Kawasaki Disease","Leiomyosarcoma","Leiomyosarcoma of the Corpus Uteri","Leiomyosarcoma of the Cervix Uteri","Leiomyosarcoma of Small Intestine","Acquired Myasthenia Gravis","Addison Disease","Hyperacusis (Hyperacousis)","Juvenile Myasthenia Gravis","Transient Neonatal Myasthenia Gravis","Williams Syndrome","Lyme Disease","Myasthenia Gravis","Marinesco Sjogren Syndrome(Marinesco-Sjogren Syndrome)","Isolated Klippel-Feil Syndrome","Frasier Syndrome","Denys-Drash Syndrome","Beckwith-Wiedemann Syndrome","Emanuel Syndrome","Isolated Aniridia","Axenfeld-Rieger Syndrome","Aniridia-intellectual Disability Syndrome","Aniridia - Renal Agenesis - Psychomotor Retardation","Aniridia - Ptosis - Intellectual Disability - Familial Obesity","Aniridia - Cerebellar Ataxia - Intellectual Disability","Aniridia - Absent Patella","Aniridia","Peters Anomaly - Cataract","Peters Anomaly","Potocki-Shaffer Syndrome","Silver-Russell Syndrome Due to Maternal Uniparental Disomy of Chromosome 11","Silver-Russell Syndrome Due to Imprinting Defect of 11p15","Silver-Russell Syndrome Due to 11p15 Microduplication","Syndromic Aniridia","WAGR Syndrome","Wolf-Hirschhorn Syndrome","4p16.3 Microduplication Syndrome","4p Deletion Syndrome, Non-Wolf-Hirschhorn Syndrome","Autosomal Recessive Stickler Syndrome","Stickler Syndrome Type 2","Stickler Syndrome Type 1","Stickler Syndrome","Mucolipidosis Type 4","X-linked Spinocerebellar Ataxia Type 4","X-linked Spinocerebellar Ataxia Type 3","X-linked Intellectual Disability - Ataxia - Apraxia","X-linked Progressive Cerebellar Ataxia","X-linked Non Progressive Cerebellar Ataxia","X-linked Cerebellar Ataxia","Vitamin B12 Deficiency Ataxia","Toxic Exposure Ataxia","Unclassified Autosomal Dominant Spinocerebellar Ataxia","Thyroid Antibody Ataxia","Sporadic Adult-onset Ataxia of Unknown Etiology","Spinocerebellar Ataxia With Oculomotor Anomaly","Spinocerebellar Ataxia With Epilepsy","Spinocerebellar Ataxia With Axonal Neuropathy Type 2","Spinocerebellar Ataxia Type 8","Spinocerebellar Ataxia Type 7","Spinocerebellar Ataxia Type 6","Spinocerebellar Ataxia Type 5","Spinocerebellar Ataxia Type 4","Spinocerebellar Ataxia Type 37","Spinocerebellar Ataxia Type 36","Spinocerebellar Ataxia Type 35","Spinocerebellar Ataxia Type 34","Spinocerebellar Ataxia Type 32","Spinocerebellar Ataxia Type 31","Spinocerebellar Ataxia Type 30","Spinocerebellar Ataxia Type 3","Spinocerebellar Ataxia Type 29","Spinocerebellar Ataxia Type 28","Spinocerebellar Ataxia Type 27","Spinocerebellar Ataxia Type 26","Spinocerebellar Ataxia Type 25","Spinocerebellar Ataxia Type 23","Spinocerebellar Ataxia Type 22","Spinocerebellar Ataxia Type 21","Spinocerebellar Ataxia Type 20","Spinocerebellar Ataxia Type 2","Spinocerebellar Ataxia Type 19/22","Spinocerebellar Ataxia Type 18","Spinocerebellar Ataxia Type 17","Spinocerebellar Ataxia Type 16","Spinocerebellar Ataxia Type 15/16","Spinocerebellar Ataxia Type 14","Spinocerebellar Ataxia Type 13","Spinocerebellar Ataxia Type 12","Spinocerebellar Ataxia Type 11","Spinocerebellar Ataxia Type 10","Spinocerebellar Ataxia Type 1 With Axonal Neuropathy","Spinocerebellar Ataxia Type 1","Spinocerebellar Ataxia - Unknown","Spinocerebellar Ataxia - Dysmorphism","Non Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature","Spasticity-ataxia-gait Anomalies Syndrome","Spastic Ataxia With Congenital Miosis","Spastic Ataxia - Corneal Dystrophy","Spastic Ataxia","Rare Hereditary Ataxia","Rare Ataxia","Recessive Mitochondrial Ataxia Syndrome","Progressive Epilepsy and/or Ataxia With Myoclonus as a Major Feature","Posterior Column Ataxia - Retinitis Pigmentosa","Post-Stroke Ataxia","Post-Head Injury Ataxia","Post Vaccination Ataxia","Polyneuropathy - Hearing Loss - Ataxia - Retinitis Pigmentosa - Cataract","Muscular Atrophy - Ataxia - Retinitis Pigmentosa - Diabetes Mellitus","Non-hereditary Degenerative Ataxia","Paroxysmal Dystonic Choreathetosis With Episodic Ataxia and Spasticity","Olivopontocerebellar Atrophy - Deafness","NARP Syndrome","Myoclonus - Cerebellar Ataxia - Deafness","Multiple System Atrophy, Parkinsonian Type","Multiple System Atrophy, Cerebellar Type","Multiple System Atrophy","Maternally-inherited Leigh Syndrome","Machado-Joseph Disease Type 3","Machado-Joseph Disease Type 2","Machado-Joseph Disease Type 1","Leigh Syndrome","Late-onset Ataxia With Dementia","Infection or Post Infection Ataxia","GAD Ataxia","Hereditary Episodic Ataxia","Gliadin/Gluten Ataxia","Friedreich Ataxia","Fragile X-associated Tremor/Ataxia Syndrome","Familial Paroxysmal Ataxia","Exposure to Medications Ataxia","Episodic Ataxia With Slurred Speech","Episodic Ataxia Unknown Type","Episodic Ataxia Type 7","Episodic Ataxia Type 6","Episodic Ataxia Type 5","Episodic Ataxia Type 4","Episodic Ataxia Type 3","Episodic Ataxia Type 1","Epilepsy and/or Ataxia With Myoclonus as Major Feature","Early-onset Spastic Ataxia-neuropathy Syndrome","Early-onset Progressive Neurodegeneration - Blindness - Ataxia - Spasticity","Early-onset Cerebellar Ataxia With Retained Tendon Reflexes","Early-onset Ataxia With Dementia","Childhood-onset Autosomal Recessive Slowly Progressive Spinocerebellar Ataxia","Dilated Cardiomyopathy With Ataxia","Cataract - Ataxia - Deafness","Cerebellar Ataxia, Cayman Type","Cerebellar Ataxia With Peripheral Neuropathy","Cerebellar Ataxia - Hypogonadism","Cerebellar Ataxia - Ectodermal Dysplasia","Cerebellar Ataxia - Areflexia - Pes Cavus - Optic Atrophy - Sensorineural Hearing Loss","Brain Tumor Ataxia","Brachydactyly - Nystagmus - Cerebellar Ataxia","Benign Paroxysmal Tonic Upgaze of Childhood With Ataxia","Autosomal Recessive Syndromic Cerebellar Ataxia","Autosomal Recessive Spastic Ataxia With Leukoencephalopathy","Autosomal Recessive Spastic Ataxia of Charlevoix-Saguenay","Autosomal Recessive Spastic Ataxia - Optic Atrophy - Dysarthria","Autosomal Recessive Spastic Ataxia","Autosomal Recessive Metabolic Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to Repeat Expansions That do Not Encode Polyglutamine","Autosomal Recessive Ataxia, Beauce Type","Autosomal Recessive Ataxia Due to Ubiquinone Deficiency","Autosomal Recessive Ataxia Due to PEX10 Deficiency","Autosomal Recessive Degenerative and Progressive Cerebellar Ataxia","Autosomal Recessive Congenital Cerebellar Ataxia Due to MGLUR1 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia Due to GRID2 Deficiency","Autosomal Recessive Congenital Cerebellar Ataxia","Autosomal Recessive Cerebellar Ataxia-pyramidal Signs-nystagmus-oculomotor Apraxia Syndrome","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to WWOX Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to TUD Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome Due to KIAA0226 Deficiency","Autosomal Recessive Cerebellar Ataxia-epilepsy-intellectual Disability Syndrome","Autosomal Recessive Cerebellar Ataxia With Late-onset Spasticity","Autosomal Recessive Cerebellar Ataxia Due to STUB1 Deficiency","Autosomal Recessive Cerebellar Ataxia Due to a DNA Repair Defect","Autosomal Recessive Cerebellar Ataxia - Saccadic Intrusion","Autosomal Recessive Cerebellar Ataxia - Psychomotor Retardation","Autosomal Recessive Cerebellar Ataxia - Blindness - Deafness","Autosomal Recessive Cerebellar Ataxia","Autosomal Dominant Spinocerebellar Ataxia Due to a Polyglutamine Anomaly","Autosomal Dominant Spinocerebellar Ataxia Due to a Point Mutation","Autosomal Dominant Spinocerebellar Ataxia Due to a Channelopathy","Autosomal Dominant Spastic Ataxia Type 1","Autosomal Dominant Spastic Ataxia","Autosomal Dominant Optic Atrophy","Ataxia-telangiectasia Variant","Ataxia-telangiectasia","Autosomal Dominant Cerebellar Ataxia, Deafness and Narcolepsy","Autosomal Dominant Cerebellar Ataxia Type 4","Autosomal Dominant Cerebellar Ataxia Type 3","Autosomal Dominant Cerebellar Ataxia Type 2","Autosomal Dominant Cerebellar Ataxia Type 1","Autosomal Dominant Cerebellar Ataxia","Ataxia-telangiectasia-like Disorder","Ataxia With Vitamin E Deficiency","Ataxia With Dementia","Ataxia - Oculomotor Apraxia Type 1","Ataxia - Other","Ataxia - Genetic Diagnosis - Unknown","Acquired Ataxia","Adult-onset Autosomal Recessive Cerebellar Ataxia","Alcohol Related Ataxia","Multiple Endocrine Neoplasia","Multiple Endocrine Neoplasia Type II","Multiple Endocrine Neoplasia Type 1","Multiple Endocrine Neoplasia Type 2","Multiple Endocrine Neoplasia, Type IV","Multiple Endocrine Neoplasia, Type 3","Multiple Endocrine Neoplasia (MEN) Syndrome","Multiple Endocrine Neoplasia Type 2B","Multiple Endocrine Neoplasia Type 2A","Atypical Hemolytic Uremic Syndrome","Atypical HUS","Wiedemann-Steiner Syndrome","Breast Implant-Associated Anaplastic Large Cell Lymphoma","Autoimmune/Inflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis","Behcet&#39;s Disease","Alagille Syndrome","Inclusion Body Myopathy With Early-onset Paget Disease and Frontotemporal Dementia (IBMPFD)","Lowe Syndrome","Pitt Hopkins Syndrome","1p36 Deletion Syndrome","Jansen Type Metaphyseal Chondrodysplasia","Cockayne Syndrome","Chronic Recurrent Multifocal Osteomyelitis","CRMO","Malan Syndrome","Hereditary Sensory and Autonomic Neuropathy Type Ie","VCP Disease","Hypnic Jerking","Sleep Myoclonus","Mollaret Meningitis","Recurrent Viral Meningitis","CRB1","Leber Congenital Amaurosis","Retinitis Pigmentosa","Rare Retinal Disorder","KCNMA1-Channelopathy","Primary Biliary Cirrhosis","ZMYND11","Transient Global Amnesia","Glycogen Storage Disease","Alstrom Syndrome","White Sutton Syndrome","DNM1","EIEE31","Myhre Syndrome","Recurrent Respiratory Papillomatosis","Laryngeal Papillomatosis","Tracheal Papillomatosis","Refsum Disease","Nicolaides Baraitser Syndrome","Leukodystrophy","Tango2","Cauda Equina Syndrome","Rare Gastrointestinal Disorders","Achalasia-Addisonian Syndrome","Achalasia Cardia","Achalasia Icrocephaly Syndrome","Anal Fistula","Congenital Sucrase-Isomaltase Deficiency","Eosinophilic Gastroenteritis","Idiopathic Gastroparesis","Hirschsprung Disease","Rare Inflammatory Bowel Disease","Intestinal Pseudo-Obstruction","Scleroderma","Short Bowel Syndrome","Sacral Agenesis","Sacral Agenesis Syndrome","Caudal Regression","Scheuermann Disease","SMC1A Truncated Mutations (Causing Loss of Gene Function)","Cystinosis","Juvenile Nephropathic Cystinosis","Nephropathic Cystinosis","Kennedy Disease","Spinal Bulbar Muscular Atrophy","Warburg Micro Syndrome","Mucolipidoses","Mitochondrial Diseases","Mitochondrial Aminoacyl-tRNA Synthetases","Mt-aaRS Disorders","Hypertrophic Olivary Degeneration","Non-Ketotic Hyperglycinemia","Fish Odor Syndrome","Halitosis","Isolated Congenital Asplenia","Lambert Eaton (LEMS)","Biliary Atresia","STAG1 Gene Mutation","Coffin Lowry Syndrome","Borjeson-Forssman-Lehman Syndrome","Blau Syndrome","Arginase 1 Deficiency","HSPB8 Myopathy","Beta-Mannosidosis","TBX4 Syndrome","DHDDS Gene Mutations","MAND-MBD5-Associated Neurodevelopmental Disorder","Constitutional Mismatch Repair Deficiency (CMMRD)","SPATA5 Disorder","SPATA5L1 Related Disorder","Acrodysostosis","Multi-systematic Smooth Muscle Dysfunction Syndrome","CRELD1 (Cysteine Rich With EGF Like Domains 1)","GNB1 Syndrome","Pyruvate Dehydrogenase Complex Deficiency Disease","Beta Mannosidosis","Kbg Syndrome","Labrune Syndrome","Metachromatic Leukodystrophy (MLD)","Moyamoya Disease","OPHN1 Syndrome","Oculopharyngeal Muscular Dystrophy (OPMD)","TUBB3 Mutation","WOREE (WWOX-related Epileptic Encephalopathy","SCAR12","Skraban-Deardorff Syndrome","Hereditary Myopathy With Early Respiratory Failure","Parry Romberg Syndrome","Lesch-Nyhan Disease","GNB1 Gene Mutation","Pierpont Syndrome","TBL1XR1 Gene Variant","Activated PI3K Delta Syndrome (APDS)","Adult Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia (ALSP)","Brain Abnormalities, Neurodegeneration, and Dysosteosclerosis","CSF1R Related Disease (CSF1R-RD)","Hereditary Diffuse Leukoencephalopathy With Axonal Spheroids and Pigmented Glia","Nasu-Hakola Disease"],"keywords":["Rare Diseases","Neglected Diseases","Orphan Diseases","Rare Disease Research","Registries","WAGR Syndrome","Ataxia","Cornelia de Lange Syndrome","Stickler Syndrome","Ataxia Telangiectasia","Kawasaki Disease","Batten Disease","Mucolipidosis IV","Klippel-Feil Syndrome","Multiple Endocrine Neoplasia","Atypical Hemolytic Uremic Syndrome","Undiagnosed","Uncommon Disease","Kabuki Syndrome","Hypersomnia","Hyperacusis","Kleine-Levin Syndrome","Marinesco-Sjogren Syndrome","Leiomyosarcoma","4p-/Wolf-Hirschhorn Syndrome","Hypophosphatasia","Narcolepsy","Wiedermann-Steiner Syndrome","Breast Implant-Associated Anaplastic Large Cell Lymphoma","Autoimmune/inflammatory Syndrome Induced by Adjuvants (ASIA)","Hemophagocytic Lymphohistiocytosis (HLH)","Behcet&#39;s Disease","Alagille Syndrome","Inclusion body myopathy with early-onset Paget disease and frontotemporal dementia (IBMPFD)","Lowe Syndrome","Pitt Hopkins Syndrome","1p36 deletion syndrome","Jansen metaphyseal chondrodysplasia","Cockayne Syndrome","Chronic recurrent multifocal osteomyelitis (CRMO)","Malan syndrome","Hereditary Sensory and Autonomic Neuropathy","Cystinosis","Juvenile nephropathic cystinosis","Nephropathic infantile cystinosis","Ocular cystinosis","Kennedy disease","Spinal Bulbar Muscular Atrophy (SBMA)","SMC1A Truncated Mutations (causing loss of gene function)","Leigh syndrome","Warburg Micro Syndrome","Mucolipidosis","Mitochondrial aminoacyl-tRNA synthetases (Mt-aaRS Disorders)","Shine Syndrome","Hypertrophic Olivary Degeneration","Non-Ketotic Hyperglycinemia","Intestinal Bromhidrosis Syndrome","Fish odor syndrome","Autosomal recessive extra oral halitosis","CACNA1H mutation","Dimethylglycine dehydrogenase deficiency","Parry Romberg Syndrome","Nasu-Hakola disease"],"interventions":[],"enrollment":20000,"startDate":"2010-07","completionDate":"2100-12","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an unaffected carrier of a rare/uncommon disease\n\nExclusion Criteria:\n\n* Diagnosis of a disease which is not rare","locations":[{"facility":"Sanford Health","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"CoRDS Team","phone":"1-877-658-9192","email":"cords@sanfordhealth.org"}],"primaryOutcomes":["To accelerate research into rare disorders by connecting individuals who are interested in research and who have been diagnosed with a rare disorder (or a disorder of unknown prevalence, or who are undiagnosed) with researchers who study rare diseases."],"hasResults":false,"conditionSlugs":["lymphoma","als","epilepsy","stroke","obesity"],"drugSlugs":[],"locationSlugs":["sioux-falls-south-dakota"],"enrichment":{"headline":"Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford","inPlainEnglish":"The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.","whoItsFor":["Diagnosis of a rare disease, a disease of unknown prevalence, undiagnosed or an unaffected carrier of a rare/uncommon disease"],"whoShouldSkip":["Diagnosis of a disease which is not rare"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20,000 people at Sioux Falls. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.915Z"},{"nctId":"NCT01834001","title":"Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy","officialTitle":"Evaluation of Local Response of Prostate Cancer to Irradiation Using Multiparametric MRI and MR-Guided Biopsies","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\n\\- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die. Radiation can be effective, but some tumors may be harder to treat with radiation or even with surgery. This happens to a small number of men who have either radiation or surgery for prostate cancer. Most men who have these hard-to-treat tumors do not know if the tumor has recurred only in the prostate or has spread to another area. Also, men whose prostate cancer has recurred only after radiation may have different treatment options. This study will use improved imaging studies to better understand why some men do not respond as well to initial radiation treatments.\n\nObjectives:\n\n\\- To use detailed imaging studies to look at the results of local radiation therapy for prostate cancer.\n\nEligibility:\n\n* Men at least 18 years of age who are scheduled to have radiation for prostate cancer.\n* Men at least 18 years of age whose prostate cancer has returned after earlier treatments.\n\nDesign:\n\n* All participants will have a medical history and physical exam. Blood and urine samples will be collected. Imaging studies will be used to evaluate the cancer at the start of the study.\n* All participants will have an initial full magnetic resonance imaging (MRI) scan of the prostate. Tumor and healthy tissue samples will be collected.\n* Those whose cancer has recurred after treatment will discuss possible treatment options with the study doctors.\n* Participants who are scheduled to have radiation will have radiation therapy. This will be given according to the current standard of treatment.\n* After radiation, participants will have regular follow-up tests and imaging studies. They will have another full MRI scan 6 months after the end of radiation treatment.","conditions":["Prostatic Neoplasms","Prostate Cancer"],"keywords":["Prostatic Neoplasms","Radiation","Biochemical Failure","Natural History"],"interventions":[],"enrollment":300,"startDate":"2013-11-13","completionDate":"2027-02-25","sex":"MALE","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA: men with untreated prostate cancer.\n\n  1. Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI.\n  2. Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion).\n  3. No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer.\n  4. Age \\>18 years.\n  5. ECOG performance status \\<2 (Karnofsky \\>60%).\n  6. Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment.\n  7. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nINCLUSION CRITERIA: for men with presumed prostate cancer relapse\n\n1. Patients must have a history of histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI\n2. Age greater than or equal to 18 years.\n3. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).\n4. Radiotherapy (external beam irradiation alone or in combination with hormonal therapy and/or brachytherapy) was delivered as definitive therapy for prostate cancer and documentation is available.\n5. Evidence of prostate cancer recurrence (biochemical relapse by the Phoenix definition, enlarging palpable prostatic abnormality, imaging evidence strongly suggestive of local failure)\n6. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n1. Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI).\n2. Evidence of metastases (pelvic lymph node involvement is not an exclusion criteria). For patients with recurrent prostate cancer, oligometastatic disease (3 or fewer visible metastases) is not an exclusion criterion.\n3. Patients with coagulopathies who are at increased risk for bleeding or on active anticoagulation therapy (platelets less than 100,000 per mm\\^3 or PT/PTT greater than 1.5 times the upper normal limit (UNL). Patients are eligible if the underlying cause is correctable.\n4. Subject s weight exceeding MRI or radiation treatment table tolerance.\n5. Patients with active urinary tract infections.\n6. Patients with renal insufficiency with a GFR less than 30, due to the fact that they will not be able to undergo gadolinium enhanced MRI.\n7. Uncontrolled illness or comorbidity that in the judgment of the PI would preclude participation in the study.\n8. Hepatitis B or Hepatitis C active infection.\n9. HIV-positive patients are ineligible because HIV is known to increase radiation toxicity and may result in under-dosing or alterations in the treatment plan that would alter the likelihood of local recurrence. Appropriate studies will be undertaken in HIV positive patients when indicated.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rukayat O Salau","phone":"(240) 858-3712","email":"rukayat.salau@nih.gov"},{"name":"Deborah E Citrin, M.D.","phone":"(240) 760-6206","email":"citrind@mail.nih.gov"}],"primaryOutcomes":["To determine the rate of local recurrence in patients with prostate cancer treated with radiotherapy using multiparametric prostate MR -guided and standard biopsies."],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Imaging Studies to Check the Local Response of Prostate Cancer to Radiation Therapy","inPlainEnglish":"Background: \\- Radiation is a common treatment for prostate cancer. It helps damage tumor cells and causes them to die.","whoItsFor":["Ages 18 Years to 120 Years","Men only","men with untreated prostate cancer","Patients must have histologically or cytologically confirmed prostate cancer. The outside pathology report is acceptable for study entry. Every effort will be made to acquire the outside pathology slides to be confirmed by the Laboratory of Pathology, NCI","Intermediate or high risk prostate cancer (clinical tumor stage T2b or higher, Gleason 7 or higher, or PSA greater than 10). Previously obtained MR imaging may be used for clinical T staging (extracapsular extension, seminal vesicle invasion)","No prior local therapy (prostatectomy, radiation, cryotherapy) or hormonal therapy for prostate cancer","how well you can do daily activities (ECOG score) \\<2 (Karnofsky \\>60%)","Radiotherapy is planned as definitive therapy for prostate cancer. For patients not treated at NCI ROB patients must have a radiation oncologist who is willing to collaborate with the ROB and provide documentation of treatment","who can join: for men with presumed prostate cancer relapse"],"whoShouldSkip":["Patients unable to tolerate MRI (patients with pacemakers, cerebral aneurysm clips, shrapnel injuries, or other implantable electronic devices or metal not compatible with MRI)","Evidence of metastases (pelvic lymph node involvement is not an"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.313Z"},{"nctId":"NCT01848028","title":"PsoBest - The German Psoriasis Registry","officialTitle":"Long-Term Benefits and Safety of Systemic Psoriasis Therapy: German Registry on the Treatment of Psoriasis With Biologics and Systemic Therapeutics","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Universitätsklinikum Hamburg-Eppendorf","sponsorClass":"OTHER","summary":"Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g. fumaric acids, methotrexate, ciclosporin A) and biological treatment (e.g. adalimumab, etanercept). While short- and middle-term efficacy of most systemic treatments has been shown in clinical studies (and is incorporated in international guidelines), knowledge about long-term outcomes, optimal treatment and effectiveness under real-world conditions is still missing. PsoBest, the German registry on the treatment of moderate to severe Pso and PsA started in 2008 and documents the long-term course of patients being administered any biologic or conventional systemic antipsoriatic drug authorized in Germany for the first time. The registry evaluates the long-term course of 3,500 patients with Pso and PsA treated with systemic antipsoriatics.","conditions":["Psoriasis","Psoriatic-arthritis"],"keywords":["patient registry","Germany","psoriasis","psoriatic-arthritis","biologics","Psonet","effectiveness","safety","biosimilars"],"interventions":[],"enrollment":3500,"startDate":"2008-01","completionDate":"2032-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist\n* age ≥ 18 years\n* being administered a specific systemic drug for the first time\n* informed consent to participate\n* sufficient language skills (German)\n\nExclusion criteria:\n\n* lack of informed consent\n* patients being participants of clinical trials at the day of admission to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analysed separately)","locations":[{"facility":"Nationwide group of dermatological centers, hospitals and medical offices","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Psoriasis Area Severity Index (PASI)"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":["adalimumab"],"locationSlugs":["hamburg-germany"],"enrichment":{"headline":"PsoBest - The German Psoriasis Registry","inPlainEnglish":"Treatment of moderate to severe Psoriasis (Pso) and Psoriasis-Arthritis (PsA) is largely confined to systemic therapy in Germany. Systemic therapy includes conventional systemic therapy (e.g.","whoItsFor":["Ages 18 Years to any","patients with diagnosis of plaque-type psoriasis or psoriasis arthritis confirmed by a dermatologist","being administered a specific systemic drug for the first time","sufficient language skills (German)"],"whoShouldSkip":["patients being participants of clinical trials at the day of admission to the registry (if a patient is included into a clinical trial during the registry follow-ups, the patient data will be recorded, but analysed separately)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,500 people at Hamburg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.584Z"},{"nctId":"NCT01950572","title":"Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma","officialTitle":"Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma and Other Mesothelin Expressing Cancers","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\n* Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis.\n* Mesothelioma accounts for 0.10% of deaths annually in the United States. Malignant pleural mesothelioma is the most common of these, comprising of 80% of the cases with an annual incidence of about 2,500 in the United States.\n* The median survival from diagnosis of pleural mesothelioma is approximately 12 months. The majority of patients present with stage III or IV disease with 85-90% of patients considered unresectable at diagnosis.\n* Peritoneal mesothelioma has a better prognosis than pleural mesothelioma; nevertheless, patients undergoing therapy for peritoneal mesothelioma have few well-studied treatment options due in large part to the rarity of the disease.\n* In addition to mesothelioma, mesothelin is highly expressed in several cancers, including pancreatic, biliary adenocarcinomas, gastric and ovarian cancers; mesothelin is also expressed in a significantly larger proportion of thymic carcinoma than thymoma.\n\nObjectives:\n\n-To allow sample acquisition for use in the study of mesothelioma.\n\nEligibility:\n\n* All participants age greater than or equal to 2 years with malignant mesothelioma OR\n* All participants greater than or equal to 18 years with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin\n* Must be able and willing to provide informed consent if 18 or over; parent or guardian must be able and willing to provide consent for patients under the age of 18\n\nDesign:\n\n* Up to 1000 subjects will be enrolled.\n* Patients will be followed to determine the course of disease and to record any treatment received for mesothelioma.\n* Patients will undergo sampling of blood, urine, tumor and abnormal body fluids for tissue banking.\n* Studies which may be performed on banked material include genetic and genomic studies, establishment of cell cultures and immunologic studies....","conditions":["Thymoma","Stomach Neoplasms","Pancreatic Neoplasms","Mesothelioma","Biliary Tract Neoplasms","Mesothelin Expressing Neoplasms"],"keywords":["Samples","Biobank","Lung Neoplasms","Ovarian Neoplasms","Natural History"],"interventions":[],"enrollment":1000,"startDate":"2013-09-09","completionDate":"2033-07-25","sex":"ALL","minAge":"2 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* All participants \\>= 2 years of age with malignant mesothelioma.\n* All participants \\>=18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin.\n* Confirmed pathological diagnosis is required\n* Ability and willingness of participant to provide informed consent to participation.\n\nEXCLUSION CRITERIA:\n\n* Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction.\n* Pregnant women.\n* Active concomitant medical or psychological illnesses that may increase the risk to the participant or in adult participants, inability to obtain informed consent, at the discretion of the principal investigator.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cathy I Wagner, R.N.","phone":"(240) 858-3159","email":"cathy.wagner@nih.gov"},{"name":"Raffit Hassan, M.D.","phone":"(240) 760-6232","email":"rh276q@nih.gov"}],"primaryOutcomes":["sample aquisition"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma","inPlainEnglish":"Background: * Malignant mesothelioma is a malignancy arising from the mesothelial cells of the pleura, peritoneum, pericardium, or tunica vaginalis. * Mesothelioma accounts for 0.10% of deaths annually in the United States.","whoItsFor":["Ages 2 Years to 100 Years","All participants \\>= 2 years of age with malignant mesothelioma","All participants \\>=18 years of age with thymic carcinoma, pancreatic or biliary adenocarcinoma or lung, gastric or ovarian cancers or other solid tumor known to express mesothelin","Confirmed pathological diagnosis is required"],"whoShouldSkip":["Active symptomatic major organ disorder that would increase the risk of biopsy, including but not limited to ischemic heart disease, recent myocardial infarction, active congestive heart failure, pulmonary dysfunction"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.458Z"},{"nctId":"NCT02327884","title":"Characterization of Diseases With Salivary Gland Involvement","officialTitle":"Characterization of Diseases With Salivary Gland Involvement","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","sponsorClass":"NIH","summary":"Background:\n\n\\- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.\n\nObjectives:\n\n\\- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives.\n\nEligibility:\n\n* People more than 4 years old who have or are suspected to have a disease involving salivary glands.\n* Their relatives more than 4 years old.\n* Healthy volunteers 18 years or older.\n\nDesign:\n\n* Participants may be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* General oral and dental history and exam\n* Saliva collection\n* Eye exam and test for dry eyes\n* Health questionnaires (adults)\n* Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed.\n* Participants will have 2-3 visits. These may include:\n* Repeats of some screening tests\n* Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand.\n* Adults may have other biopsies\n* A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct.\n* Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup\n* Scrapings collected from teeth, tongue, and cheeks","conditions":["Healthy Volunteer","Sjogren's Syndrome","Salivary Gland Disease"],"keywords":["Genetics","Dry Mouth","Sjogren's Syndrome","Gland dysfunction","Induced Pluripotent Stem (iPS) Cell Lines"],"interventions":[],"enrollment":1150,"startDate":"2015-04-03","completionDate":"2032-04-01","sex":"ALL","minAge":"4 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Persons older than 4 years of age, affected with or suspected of being affected with a disease/disorder involving the salivary glands or who is a relative of a person who is affected with these diseases/disorders.\n\nOr,\n\n\\- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.\n\nSpecific to patients undergoing immunotherapy with an immune checkpoint inhibitor for threatment of oral cancer, these patients will be seen before and after check point inhibitor therapy which will coincide with 4 weeks (+/-2 weeks) before and again immediately before (+/- 2 weeks) definitive oral cancer treatment initiation (e.g., surgical resection, etc.).\n\nOr,\n\n\\- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.\n\nEXCLUSION CRITERIA:\n\n* Anyone not able to give consent/assent or parental/guardian consent\n* NIH employees who report directly to the principal investigator\n* Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders.\n\n  * Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria.\n  * Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and/or oral exams, will be excluded as determined by the Principal Investigator.\n* Additional exclusion criteria for Healthy Volunteers (HV):\n\n  * Pregnancy\n  * Sicca Symptoms\n  * HIV, hepatitis B or C infection\n  * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia\n  * Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eileen M Pelayo","phone":"(301) 594-3097","email":"eileen.pelayo@nih.gov"},{"name":"Margaret E Beach, P.A.-C","phone":"(301) 451-3479","email":"margaret.beach@nih.gov"}],"primaryOutcomes":["hypothesis generating"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Characterization of Diseases With Salivary Gland Involvement","inPlainEnglish":"Background: \\- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life.","whoItsFor":["Ages 4 Years to 100 Years","Persons older than 4 years of age, affected with or suspected of being affected with a disease/disorder involving the salivary glands or who is a relative of a person who is affected with these diseases/disorders","\\- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer","\\- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied"],"whoShouldSkip":["NIH employees who report directly to the principal investigator","Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders","Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,150 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.960Z"},{"nctId":"NCT02417740","title":"Natural History of Noncirrhotic Portal Hypertension","officialTitle":"Natural History of Noncirrhotic Portal Hypertension","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Background:\n\n\\- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs. Many people may not even know that they have a liver disease. There are no specific treatments for NCPH.\n\nObjectives:\n\n\\- To learn more about how NCPH develops over time.\n\nEligibility:\n\n\\- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they cannot have had other types of liver disease that typically result in cirrhosis, liver cancer, or active substance abuse.\n\nDesign:\n\n* Participants will have 2 screening visits.\n* Visit 1: to see if they have or may develop NCPH.\n* Medical history\n* Physical exam\n* Urine and stool studies\n* Abdominal ultrasound\n* Fibroscan. Sound waves measure liver stiffness.\n\n\\<TAB\\>- Visit 2:\n\n* Blood tests\n* Abdominal MRI\n* Echocardiogram\n* Questionnaire\n* Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is done with a small tube inserted in a neck vein.\n* They may have a liver biopsy.\n* All participants will visit the clinic every 6 months for a history, physical exam, and blood tests. They will also repeat some of the screening tests yearly.\n* Participants with NCPH will also have:\n* Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and stomach.\n* At least every 2 years: Esophagogastroduodenoscopy.\n* At least every 4 years: testing including HVPG measurements and liver biopsy.\n* Participants without NCPH will also have:\n* Liver biopsy and HVPG measurements to see if they have NCPH.\n* Every 2 years: abdominal MRI and stool studies.\n* The study will last indefinitely.","conditions":["Cystic Fibrosis","Immunologic Deficiency Syndrome","Turner Syndrome","Congenital Hepatic Fibrosis","Idiopathic Non-Cirrhotic Portal Hypertension"],"keywords":["Portal Hypertension","Portal Fibrosis","Liver Disease","Varices","Splenomegaly","Natural History"],"interventions":[],"enrollment":400,"startDate":"2015-07-27","completionDate":"2029-09-04","sex":"ALL","minAge":"12 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Male or female, aged \\>= 18 years of age, and minors 12-17 years of age.\n* Women of childbearing potential must agree to use birth control unless they are menopausal or had hysterectomy.\n* Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy.\n* Evidence of other forms of liver disease that typically result in cirrhosis.\n* Evidence of active Chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (\\>10,000 IU/mL).\n* Hepatitis C as defined by the presence of hepatitis C RNA in serum.\n* Evidence of other liver disease such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson s disease, autoimmune hepatitis as defined by either liver histology or laboratory abnormalities.\n* Hemochromatosis as defined by presence of 3+ or 4+ stainable iron on liver biopsy or homozygosity for C282Y. Patients with iron saturation indices of \\>45% and serum ferritin levels of \\>300 ng/ml for men and \\>250 ng/ml for women will undergo genetic testing for hemochromatosis.\n* Bile duct obstruction as suggested by imaging studies done within the previous six months.\n* The presence of cirrhosis confirmed by liver biopsy.\n* Active substance abuse, such as alcohol, inhaled or injection drugs within the previous one year (assessed during subject interviews by subject self-report).\n* Evidence of hepatocellular carcinoma; either alpha-fetoprotein (AFP) levels greater than 50 ng/ml (normal \\<6.6ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.\n* Evidence of cholangiocarcinoma as suggested by liver histology.\n* Any other severe condition, which in the opinion of the investigators would impede the patient s participation or compliance in the study.\n* Inability to comply or give written informed consent.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jaha F Norman-Wheeler","phone":"(301) 435-6122","email":"jaha.norman-wheeler@nih.gov"},{"name":"Theo Heller, M.D.","phone":"(301) 402-7147","email":"theoh@intra.niddk.nih.gov"}],"primaryOutcomes":["To study the natural history of non cirrhotic portal hypertension. It is an ongoing study."],"hasResults":false,"conditionSlugs":["liver-cancer","als","hypertension"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History of Noncirrhotic Portal Hypertension","inPlainEnglish":"Background: \\- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs.","whoItsFor":["Ages 12 Years to 100 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Male or female, aged \\>= 18 years of age, and minors 12-17 years of age","Women of childbearing potential must agree to use birth control unless they are menopausal or had hysterectomy","Known diagnosis of NCPH, or to be at the risk for NCPH by virtue of underlying disease processes such as but not limited to; CGD, SCD, Mastocytosis, CVID, CF, and CHF"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Evidence of other forms of liver disease that typically result in cirrhosis","Evidence of active Chronic Hepatitis B infection as defined by the presence of hepatitis B surface antigen (HBsAg) in serum and elevated HBV DNA (\\>10,000 IU/mL)","Hepatitis C as defined by the presence of hepatitis C RNA in serum","Evidence of other liver disease such as primary sclerosing cholangitis, primary biliary cirrhosis, Wilson s disease, autoimmune hepatitis as defined by either liver histology or laboratory abnormalities","Bile duct obstruction as suggested by imaging studies done within the previous six months","The presence of cirrhosis confirmed by liver biopsy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.037Z"},{"nctId":"NCT02418442","title":"Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry","officialTitle":"Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Duke University","sponsorClass":"OTHER","summary":"Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including safety questions.","conditions":["Rheumatic Joint Disease"],"keywords":["Systemic Arthritis","Oligoarthritis","Polyarthritis (Rheumatoid Factor Negative)","Polyarthritis (Rheumatoid Factor Positive)","Psoriatic Arthritis","Enthesitis Related Arthritis (ERA)","Undifferianted Arthritis","CARRA Consensus Treatment Plans"],"interventions":[],"enrollment":20000,"startDate":"2015-07","completionDate":"2028-06","sex":"ALL","minAge":null,"maxAge":"21 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A).\n2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.\n3. Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.\n\nExclusion Criteria:\n\n1\\. Greater than 21 years of age at the time of enrollment.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoenix Children's Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mattel Children's Hospital at University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University Medical Center","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rady Children's Hospital San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California at San Francisco Medical Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Connecticut Children's Medical Center","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Childrens National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida - Shand's Children's Hospital","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nicklaus Children's Hospital","city":"Miami","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Nemours Children's Hospital","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins All Children's Hospital","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Children's Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georgia Regents University Medical Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois at Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital)","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Louisville Schoole of Medicine","city":"Louisville","state":"Kentucky","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Children's Hospital / Carolinas Medical Center","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Children's Hospital & Health Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest Baptist Brenner Children's Hospital","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Health","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Akron Children's Hospital","city":"Akron","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UH Rainbox Babies and Children's Hospital","city":"Cleveland","state":"Ohio","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Metrohealth Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Randall Children's Hospital at Legacy Emanuel","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Children's Hospital","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Christopher's Hospital for Children","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Pittsburgh UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hasbro Children's Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina Children's Hospital","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Carrell Jr. Children's Hospital at Vanderbilt","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine Pediatric Immunology Allergy Rheumatology","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Hospitals and Clinics (Primary Children's Hospital)","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Vermont Medical Center","city":"Burlington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of the King's Daughters","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin, American Family Children's Hospital","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Of Wisconsin","city":"Wauwatosa","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Calgary - Alberta Children's Hospital","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Manitoba - Children's Hospital of Manitoba","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"IWK Health Center","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Schneider Children's Medical Center of Israel","city":"Petah Tikva","state":"","country":"Israel","status":"TERMINATED","lat":null,"lon":null},{"facility":"IRCCS Ospedale Pediatrico Bambino Gesu (OPBG)","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"San Jorge Children's Hospital","city":"San Juan","state":"","country":"Puerto Rico","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Mara L Becker, MD, MSCE","phone":"(919) 419-5032","email":"mara.becker@duke.edu"},{"name":"Mary Beth Son, MD","phone":"(617) 919-6083","email":"marybeth.son@childrens.harvard.edu"}],"primaryOutcomes":["Prospectively collect essential data elements from children, adolescents and young adults with pediatric rheumatic diseases","Evaluate the safety of therapeutic agents in persons with pediatric onset rheumatic diseases"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","los-angeles-california","palo-alto-california","san-diego-california","san-francisco-california","aurora-colorado","hartford-connecticut","new-haven-connecticut","washington-d-c-district-of-columbia","gainesville-florida","miami-florida","orlando-florida","st-petersburg-florida","atlanta-georgia","augusta-georgia","chicago-illinois","indianapolis-indiana","iowa-city-iowa","kansas-city-kansas","louisville-kentucky","boston-massachusetts","springfield-massachusetts","ann-arbor-michigan","grand-rapids-michigan","minneapolis-minnesota","rochester-minnesota","jackson-mississippi","kansas-city-missouri","st-louis-missouri","hackensack-new-jersey","morristown-new-jersey","new-brunswick-new-jersey","west-orange-new-jersey","albany-new-york","lake-success-new-york","new-york-new-york","rochester-new-york","chapel-hill-north-carolina","charlotte-north-carolina","durham-north-carolina","winston-salem-north-carolina","fargo-north-dakota","akron-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","portland-oregon","hershey-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","providence-rhode-island","charleston-south-carolina","nashville-tennessee","dallas-texas","houston-texas","salt-lake-city-utah","burlington-vermont","norfolk-virginia","seattle-washington","madison-wisconsin","wauwatosa-wisconsin","calgary-canada","winnipeg-canada","halifax-canada","toronto-canada","petah-tikva-israel","rome-italy","san-juan-puerto-rico"],"enrichment":{"headline":"Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry","inPlainEnglish":"Continuation of the CARRA Registry as described in the protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies.","whoItsFor":["Ages any to 21 Years","Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A)","Subject and/or parent/legal guardian is willing to be contacted in the future by study staff"],"whoShouldSkip":["1\\. Greater than 21 years of age at the time of enrollment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20,000 people at 82 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.965Z"},{"nctId":"NCT02421705","title":"Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)","officialTitle":"Visceral Sensitivity in IBD and IBS: Role of Inflammation, Immune Activity and Genetic Factors","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"KU Leuven","sponsorClass":"OTHER","summary":"Aim:\n\nMore insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.","conditions":["IBS","Ulcerative Colitis, Active","Ulcerative Colitis, Remission (3a: With IBS Symptoms, 3b: Without IBS Symptoms)","Healthy Controls","Crohn's Disease, Active","Crohn's Disease, Remission (6a: With IBS Symptoms, 6b: Without IBS Symptoms)"],"keywords":[],"interventions":[{"type":"OTHER","name":"Sample collection"}],"enrollment":99999999,"startDate":"2010-03-12","completionDate":"2099-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nFor group 1: IBS\n\n1. Irritable Bowel Syndrome (IBS) (ROME III criteria)\n2. No obvious organic explanation for the IBS symptoms\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)\n\n1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)\n2. remission is confirmed by at least one sigmoidoscopy\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\n   Only for group 3a:\n4. Rome III criteria for IBS\n\nGroup 4: Healthy controls No abdominal (pain) complaints.\n\nGroup 5: active Crohn's disease\n\n1\\. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nGroup 6: Crohn's disease in remission (6a: with IBS symptoms, 6b: without IBS symptoms)\n\n1. diagnosis of Crohn's disease (Confirmed by at least one sigmoidoscopy)\n2. remission is confirmed by at least one sigmoidoscopy\n3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study\n\nExclusion Criteria:\n\nFor all groups:\n\n1. co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting\n2. Abdominal chirurgy (except for an uncomplicated appendectomy)","locations":[{"facility":"University Hospitals Leuven","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Koen Bellens, MSc","phone":"0032-16-341943","email":"koen.bellens@kuleuven.be"}],"primaryOutcomes":["differences in visceral sensitivity in different study groups (Visceral sensitivity will me measured by performing a rectal barostat test)"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis","ibs"],"drugSlugs":[],"locationSlugs":["leuven-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Sample collection for IBS","inPlainEnglish":"Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.","whoItsFor":["Ages 18 Years to 65 Years","Irritable Bowel Syndrome (IBS) (ROME III criteria)","No obvious organic explanation for the IBS symptoms","Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study","Group 2: active ulcerative colitis 1. diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy) 3. Medication which affects the gastrointestinal motility or perception should be stopped at least 24 hours before the study","Group 3: ulcerative colitis in remission (3a: with IBS symptoms, 3b: without IBS symptoms)","diagnosis of ulcerative colitis (Confirmed by at least one sigmoidoscopy)","remission is confirmed by at least one sigmoidoscopy"],"whoShouldSkip":["co-morbidity: severe kidney- and/or liver disease or thyroid abnormalities and impaired clotting","Abdominal chirurgy (except for an uncomplicated appendectomy)"],"whatHappens":"If you join, the listed intervention(s) are Sample collection. The registry lists allocation as na. Aim: More insight in pathogenesis of IBS and IBD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 99,999,999 people at Leuven. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.432Z"},{"nctId":"NCT02438904","title":"Compassionate Access of the Miltenyi Device for CD34+ Cell Selection","officialTitle":"Compassionate Access of the Miltenyi Device for CD34+ Cell Selection","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"Objectives:\n\nPrimary Objective\n\nTo provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).","conditions":["Blood And Marrow Transplantation"],"keywords":["Blood And Marrow Transplantation","Stem cell transplantation","SCT","Poor graft function","CD34+ cell infusion"],"interventions":[{"type":"BIOLOGICAL","name":"CD34 Positive Stem Cell Infusion"},{"type":"DEVICE","name":"Miltenyi device"}],"enrollment":200,"startDate":"2015-05-06","completionDate":"2027-05-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\) Patients who have poor or no graft function post stem cell transplantation.\n\nExclusion Criteria:\n\nN/A","locations":[{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elizabeth Shpall, MD","phone":"713-745-2161","email":"eshpall@mdanderson.org"}],"primaryOutcomes":["Increased Graft Function after Stem Cell Transplantation (SCT)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: testing CD34 Positive Stem Cell Infusion for Blood And Marrow Transplantation","inPlainEnglish":"Objectives: Primary Objective To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).","whoItsFor":["1\\) Patients who have poor or no graft function post stem cell transplantation"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are CD34 Positive Stem Cell Infusion, or Miltenyi device. The registry lists allocation as na. Objectives: Primary Objective To provide compassionate access to the Miltenyi device for CD34+ cell infusions to patients who experience poor graft function after stem cell transplantation (SCT).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Houston. Taking part typically means an infusion or injection of a biologic, using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.113Z"},{"nctId":"NCT02504853","title":"Natural History and Genetics of Food Allergy and Related Conditions","officialTitle":"Natural History and Genetics of Food Allergy and Related Conditions","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\n\\- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.\n\nObjective:\n\n\\- To learn more about the causes and effects of food allergy and related conditions.\n\nEligibility:\n\n* People ages 2 99 who have food allergy and/or a related genetic or other condition\n* Their relatives\n* Healthy relatives and volunteers\n\nDesign:\n\n* Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer.\n* Participants will be screened with medical history, physical exam, and questionnaires.\n* Participants may have the following:\n* Blood tests\n* Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop.\n* Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm.\n* X-rays\n* Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour.\n* EGD and colonoscopy: Biopsies are taken from the gastrointestinal system.\n* Tiny biopsies of skin\n* Photographs of the body\n* Collection of cells through:\n* Swab of nose, inside of cheek, or skin\n* Gentle skin scrape\n* Tape stripping: piece of tape is put on the skin and pulled off.","conditions":["Food Allergy","Loeys-Dietz Syndrome","Atopic Dermatitis","Eosinophilic Esophagitis"],"keywords":["Eosinophilic Esophagitis","Loeys-Dietz Syndrome","Atopic Dermatitis","TGFbeta","Natural History"],"interventions":[],"enrollment":1800,"startDate":"2015-07-29","completionDate":"2027-06-15","sex":"ALL","minAge":"1 Day","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"* GENERAL INCLUSION CRITERIA:\n\nAll participants must meet the following criteria:\n\n1. Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled.\n2. Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research\n3. Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives\n\nADDITIONAL INCLUSION CRITERIA FOR AFFECTED PARTICIPANTS\n\nIn addition to the general criteria listed above, affected participants must meet 1 of the following criteria:\n\n1. Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)\n2. Be sensitized (as evidenced by positive SPT or allergen-specific IgE testing) to food allergen(s) but have no overt clinical history of IgE-mediated symptoms when they eat that food(s)\n3. Have a suspected genetic or congenital disorder potentially associated with food allergy or related condition, as determined by the principal investigator (PI) or associate investigators (AIs)\n4. Have a diagnosis of eosinophilic esophagitis (EoE), or clinical suspicion for EoE as determined by the principal investigator (PI) or associate investigators (AIs)\n5. Have a history of atopic dermatitis based on self-report or physician assessment.\n\nADDITIONAL INCLUSION CRITERIA FOR UNAFFECTED RELATIVES:\n\nIn addition to the general criteria listed above, unaffected relatives must meet the following criteria:\n\n1. Be a relative of an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS\n\nIn addition to the general criteria listed above, healthy volunteers must meet the following criteria:\n\n1. Be unrelated to an affected participant\n2. Be unaffected by food allergy (as determined by clinical history and/or allergy testing) or be unaffected by the genetic condition under study\n\nADDITIONAL PROCEDURE- SPECIFIC INCLUSION CRITERIA:\n\nThe following additional inclusion criteria apply for participants undergoing leukapheresis:\n\n1. Age \\>= 18 years\n2. Stable hematologic parameters (definition: white blood cell count \\> 2,500/microL, hemoglobin \\> 10 g/dL, and platelet count \\> 75,000/microL)\n\nGENERAL EXCLUSION CRITERIA:\n\nParticipants will be excluded for any of the following:\n\n* Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study.\n* Inability to participate for the duration of the study.\n* The PI deems that participation in the study would not be expected to advance the study goals.\n\nADDITIONAL PROCEDURE- SPECIFIC EXCLUSION CRITERIA\n\nAdditional exclusion criteria apply for unaffected relatives and healthy volunteers who are undergoing endoscopy with biopsies for research purposes. Unaffected relatives and healthy volunteers will be excluded from participating in this procedure if they meet any of the following criteria:\n\n1. uncontrolled asthma or Grade 3 or higher by the American Society of Anesthesiologist s Physical Status Classification System (https://journals.lww.com/anesthesiologyopen/fulltext/2026/04000/american\\_society\\_of\\_anesthesiologists\\_statement\\_on.2.aspx)\n2. history of adverse reaction to conscious sedation or general anesthesia required for endoscopy\n3. hemoglobin \\< 11 g/dL\n4. platelet count \\< 100,000 microL\n5. PT INR \\>1.3 or PTT prolonged by \\> 3 seconds\n6. pregnant or breastfeeding\n7. viral screens positive for HIV or hepatitis B or C\n8. severe unstable myocardial ischemia or cardiomyopathy\n9. severe hypoxemia due to chronic pulmonary disease\n10. recent abdominal surgery\n11. anticoagulant therapy that cannot be interrupted\n12. history of reflux disease within the last 3 years or use of acid-suppression medication (including over-the-counter medications such as Tums, Rolaids, Zantac, Prilosec OTC, or Prevacid OTC) within the last 2 months\n13. chronic GI or immunologic disease\n14. clinically indicated EGD or colonoscopy within the past 12 months\n15. use of systemic or inhaled corticosteroids within the past 4 months\n16. have a history of EGID including EoE\n17. younger than 18 years of age","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ellen Zektser, R.N.","phone":"Not Listed","email":"niaidfars@niaid.nih.gov"},{"name":"Pamela A Frischmeyer-Guerrerio, M.D.","phone":"(301) 402-9782","email":"pamela.guerrerio@nih.gov"}],"primaryOutcomes":["Investigate the key genetic, cellular, immunologic, microbial, and biochemical pathways that lead to the development of food allergy","Identify biomarkers that predict the clinical course and natural history of patients with food allergy"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History and Genetics of Food Allergy and Related Conditions","inPlainEnglish":"Background: \\- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them.","whoItsFor":["Ages 1 Day to 99 Years","All participants must meet the following criteria:","Be 2 to 99 years-old at the time of enrollment for participants who will be seen at the NIH CC; be 0 (newborn) to 99 years-old at the time of enrollment for participants who will submit mail-in samples or participate in telehealth visits. Only viable neonates will be enrolled","Willing to allow storage of blood, buccal swabs, saliva, nasal swabs, stool samples, and other clinically appropriate tissue specimens for future use in medical research","Required to have a primary care or other physician who will manage all health conditions related or unrelated to the study objectives","ADDITIONAL who can join FOR AFFECTED PARTICIPANTS","In addition to the general criteria listed above, affected participants must meet 1 of the following criteria:","Have a clinical history of an immediate hypersensitivity reaction to food(s) and be sensitized to food allergen(s) (as evidenced by positive SPT or allergen-specific IgE testing)"],"whoShouldSkip":["you would be excluded for any of the following:","Presence of conditions that, in the judgment of the investigator or the referring physician, may put the participant at undue risk or make them unsuitable for participation in the study","Inability to participate for the duration of the study","The PI deems that participation in the study would not be expected to advance the study goals","ADDITIONAL PROCEDURE- SPECIFIC"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,800 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.814Z"},{"nctId":"NCT02531880","title":"Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy","officialTitle":"Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\n\\- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures. It can affect this barrier. Researchers think a contrast agent called mangafodipir might be better able to show areas of the brain that epilepsy affects.\n\nObjective:\n\n\\- To see if mangafodipir is well tolerated and safe. To see if magnetic resonance imaging (MRI) using either mangafodipir or gadolinium can show areas of blood-brain barrier breakdown in people with epilepsy.\n\nEligibility:\n\n* People ages 18-60 who:\n* Have epilepsy not controlled by drugs\n* Prior or concurrent enrollment in 18-N-0066 is required\n\nDesign:\n\n* Participants will be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Participants will have up to 6 visits in 1-3 months. One visit is an inpatient stay lasting 2-10 days. Visits may include:\n* Video-EEG monitoring for participants with epilepsy\n* An IV catheter put in place: a needle guides a thin plastic tube into an arm vein.\n* Getting mangafodipir through the IV.\n* Getting gadolinium through the IV.\n* Up to 6 MRI scans over a 10-day period: a magnetic field and radio waves take pictures of the brain. Participants lie on a table that slides into a metal cylinder. They are in the cylinder for 45-90 minutes, lying still for up to 10 minutes at a time. The scanner makes loud knocking sounds. Participants will get earplugs.\n* A final MRI at least 2 weeks after receiving mangafodipir.","conditions":["Epilepsy"],"keywords":["MRI","Manganese Enhanced MRI","Seizure Disorder","Seizures","Epileptic Focus"],"interventions":[{"type":"DRUG","name":"Mangafodipir"},{"type":"DRUG","name":"Gadolinium"}],"enrollment":40,"startDate":"2024-11-19","completionDate":"2030-07-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Age 18-60.\n* Able to give written informed consent directly.\n* Drug resistant epilepsy participants will be defined as having clinically documented seizures with consistent EEG evidence as defined by the 1981 International Classification of Epileptic Seizures, refractory to standard anti-seizure treatment for at least one year prior to enrolling in this study and with an average of at least one seizure per month. This criterion will be established by preliminary screening NINDS Epilepsy Service under protocol 18-N-0066. Seizure focus localization will be determined by standard clinical, neurophysiologic, and imaging studies. Prior or concurrent enrollment in 18-N-0066 is required.\n\nEXCLUSION CRITERIA:\n\nGeneral exclusions:\n\n* Patients with epilepsy who are not surgical candidates\n* Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan.\n* Positive test for HIV\n* Pregnancy or breast-feeding\n* Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine.\n* Cannot lie on their back for at least two hours.\n* Risk for MRI scan, (e.g., any non-organic implant or other device such as a cardiac pacemaker or infusion pump or other metallic implants, objects or body piercings that cannot be removed, or history of being a welder or metal worker due to small metal fragments in the eye)\n* Unwilling to allow sharing and/or use in future studies of coded data that are collected for this study\n\nMEMRI component specific exclusions (applicable only to patients participating in this arm of the study):\n\n* History of post-ictal psychosis or post-ictal aggression\n* Planning to get pregnant in the next 2 months\n* History of clinically significant liver or kidney disease that could potentially increase the risk of CNS damage due to manganese exposure\n* A history of drug or alcohol abuse/dependence (subjects scoring 8 or higher on the AUDIT scale)\n* Screening lab abnormalities demonstrating values more than 2 times the upper limit of normal for AST, ALT, bilirubin, alkaline phosphatase, BUN, creatinine\n* Previous presumed occupational exposure to manganese (i.e., having worked in a mine, foundry, smelter, dry cell battery manufacturing facility, or agriculture)\n* Allergy to manganese\n* On-going treatment with calcium-channel blocker\n* Iron-deficiency anemia\n* Personal history of Parkinson s Disease or Parkinsonism or presence of this disease in a 1st degree relative\n\nGadolinium enhanced MRI component specific exclusions (applicable only to patients participating in this arm of the study):\n\n* Estimated GFR \\<60, tested within 1 week of scan\n* Allergy to gadolinium\n\nOf note, patients who are ineligible for one arm of the study may still be eligible for and participate in the other arm of the study.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aaliyah M HamidullahThiam","phone":"(301) 435-2952","email":"aaliyah.hamidullahthiam@nih.gov"},{"name":"Sara K Inati, M.D.","phone":"(301) 435-6269","email":"inatisk@mail.nih.gov"}],"primaryOutcomes":["description of the safety profile of mangafodipir administration in patients with epilepsy","evaluation of the utility of MEMRI and/or DCE-MRI in identifying focal BBBD in the seizure onset zone identified by standard clinical, EEG, and imaging studies, and the homologous contralateral region."],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Mangafodipir for Epilepsy","inPlainEnglish":"Background: \\- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures.","whoItsFor":["Ages 18 Years to 60 Years"],"whoShouldSkip":["General exclusions:","Patients with epilepsy who are not surgical candidates","Significant structural brain abnormality such as a brain tumor, stroke, brain damage from head trauma or blood vessel abnormalities, on the baseline MRI scan","Positive test for HIV","Pregnancy or breast-feeding","Claustrophobia to a degree that the subject would feel uncomfortable in the MRI machine","Cannot lie on their back for at least two hours"],"whatHappens":"If you join, the listed intervention(s) are Mangafodipir, or Gadolinium. The registry lists allocation as randomized. Background: \\- The blood-brain barrier separates the brain from the rest of the body.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 40 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.913Z"},{"nctId":"NCT02543983","title":"Neurobiology of Suicide","officialTitle":"The Neurobiology of Suicide","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nThere are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies. They hope to better understand suicide, so they can help suicidal people.\n\nObjective:\n\nTo understand what happens in the brain when someone has thought about or attempted suicide.\n\nEligibility:\n\nGroup 1: Adults ages 18 70 who have thought about or attempted suicide recently\n\nGroup 2: Adults ages 18 70 who have thought about or attempted suicide in the past\n\nGroup 3: Adults ages 18 70 who have depression or anxiety, but have never thought about suicide\n\nGroup 4: Healthy volunteers the same ages.\n\nDesign:\n\nParticipants will be screened in another protocol. Adults who have recently thought about or attempted suicide must be referred by a doctor. They may do up to 3 phases of this study. Groups 2, 3 and 4 will do only Phase 1 and will not get ketamine.\n\nPhase 1: 1 week in hospital. Participants will have:\n\nPhysical exam.\n\nQuestions about thoughts and feelings.\n\nThinking and memory tests and simple tasks.\n\nBlood and urine tests.\n\nTwo MRI scans. Participants will lie on a table that slides into a metal cylinder that takes pictures. They will have a coil over their head and earplugs and do a computer task.\n\nSleep test. Disks and bands will be placed on the body to monitor it during sleep.\n\nMagnetic detectors on their head while they perform tasks.\n\nA wrist monitor for activity and sleep.\n\nLumbar puncture (optional). A needle will collect fluid from the back.\n\nShock experiments (optional). Participants will observe pictures and sounds and feel a small shock on the hand.\n\nPhase 2: 4 days in hospital. A thin plastic tube will be placed in each arm, one for blood draws, the other to get the drug ketamine once. Participants will repeat most of the Phase 1 tests.\n\nPhase 3: up to 4 more ketamine doses over 2 weeks.\n\nParticipants will have follow-up calls or visits at 6 months and then maybe yearly for 5 years.","conditions":["Healthy Volunteers","Depression"],"keywords":["Neurobiology","Suicide","Ketamine","Major Depressive Disorder","Biomarkers"],"interventions":[{"type":"DEVICE","name":"Magnetic Resonance Imaging scanner, 3T"},{"type":"DEVICE","name":"NeurOptics PLRTM-3000 Pupillometer"},{"type":"DEVICE","name":"Experimental Anxiety Devices"},{"type":"DEVICE","name":"Magnetic Resonance Imaging scanner, 7T"},{"type":"DRUG","name":"Ketamine Hydrochloride"}],"enrollment":325,"startDate":"2015-12-01","completionDate":"2030-07-21","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score \\>= 90% on the Baseline consent quiz\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n4. Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. 18 to 70 years of age.\n2. A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document.\n3. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I.\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Patients must have completed Study Phase I as a participant in Group 1 or 5\n2. Participants must verify understanding of the protocol by a score \\>= 80% on the Ketamine Response consent quiz.\n3. Patients in Group 1 or 5 must report at least minimal suicidal ideation, depressive or anxiety symptoms to be eligible for this phase.\n\n   * MADRS score of over 10 (10 used as an outcome measure for remission)126\n   * OR HAMA score of over 7 (7 used as an outcome measure for remission)127\n   * OR SSI score of 2 or more (indicates any residual suicidal thoughts)\n4. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase II.\n\nPhase III: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II as a participant in Group 1 (active crisis) or Group 5 (Suicide Ideators).\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhase I: Groups 1-3 and 5 (Patients)\n\n1. Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations.\n2. Current drug or alcohol dependence\n3. Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study.\n4. Pregnant or nursing individuals or those who plan to become pregnant.\n5. Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.\n6. Clinically significant abnormal laboratory tests.\n7. Positive HIV test\n8. Participants who, in the investigator s judgment, pose a current homicidal risk or pose suicide risk that cannot be managed in a secure, voluntary inpatient setting.\n9. Non-English speakers\n10. Additional Criteria for Group 1 (Active Crisis): For participants who still experience the effects of their suicide attempt, i.e. someone who overdosed is significantly drowsy or confused, the consenting process will occur after the patient has improved from the effects. If there is a concern around a participant's capacity to consent, the Human Subjects Protections Unit (HSPU) team member who is\n\nmonitoring the informed consent process will complete a capacity assessment. Participants who are determined not to have capacity to consent to research will not be included in the study.\n\nPhase I: Group 4 (Healthy Volunteers)\n\n1. Current or past Axis I diagnosis\n2. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.\n3. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine) (or \"substance abuse disorder\" per DSM-V).\n4. Presence of psychiatric disorders or a history of suicide attempt or death in first-degree relatives.\n5. Pregnant or nursing individuals or those who plan to become pregnant.\n6. No lifetime suicide attempts or ideations\n7. Non-English speakers\n8. Positive HIV test\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n\nPhase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)\n\n1. Treatment with a reversible MAOI within 2 weeks prior to study Phase II.\n2. Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase II.\n3. Subjects with one or more seizures without a clear and resolved etiology\n4. Participants with a positive urine for an illicit substance no more than 24 hours prior to the ketamine infusion.\n5. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n6. Pregnant or nursing individuals or those who plan to become pregnant.\n7. A medical finding or condition that in the clinical judgement of the investigator increases the risk of adverse effects from the ketamine administration (for example: findings suggesting difficulties with kidney or cardiac function that may be contraindications for an experimental intervention).\n\nPhase III: Repeated Administration (Group 1) and Group 5 (Suicide Ideators)\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Treatment with a reversible MAOI within 2 weeks prior to study Phase III.\n3. Treatment with any other concomitant medication not allowed within 5 1/2 half-lives prior to study Phase III.\n4. Subjects with one or more seizures without a clear and resolved etiology\n5. Participants with a positive urine for an illicit substance no more than 24 hours prior to each ketamine infusion.\n6. Presence of current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-V\n7. Pregnant or nursing individuals or those who plan to become pregnant.\n\nExclusions for Imaging:\n\n1. Participants with metal objects implanted in the body, such as aneurysm clips, neural stimulators, implanted cardiac pacemakers, or auto-defibrillator, cochlear implant, or ocular foreign body which would make having an MRI scan unsafe\n2. Participants who are uncomfortable in small closed spaces (have claustrophobia) and would feel uncomfortable in the MRI machine\n3. Participants with a brain abnormality on an initial MRI scan\n4. Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laura R Waldman, L.C.S.W.","phone":"(301) 768-2833","email":"laura.waldman@nih.gov"}],"primaryOutcomes":["Study as Whole: Psychiatric, psychological, neuroimaging, sleep and biological differences between participants in Groups 1, 2, 3, 4, and 5","Phase II: Scale for Suicide Ideation","Phase II: Montgomery-Asberg Depression Rating Scale","Phase II: Hamilton Psychiatric Rating Scale for Anxiety","Phase II: Clinical Global Impression Scale"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Ketamine Hydrochloride for Healthy Volunteers","inPlainEnglish":"Background: There are no good treatments for people considering suicide. Researchers want to study suicide with questions, blood tests, brain imaging, and sleep studies.","whoItsFor":["Ages 18 Years to 70 Years","Phase I: Groups 1-3 and 5 (Patients)","18 to 70 years of age","Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase I","Additional Criteria for Group 1 (Active Crisis): Agree to be hospitalized","Phase I: Group 4 (Healthy Volunteers)","Phase II: Group 1 (Active Crisis) and Group 5 (Suicide Ideators)","Patients must have completed Study Phase I as a participant in Group 1 or 5"],"whoShouldSkip":["Phase I: Groups 1-3 and 5 (Patients)","Current psychotic features or cognitive impairment that would preclude understanding of the consenting process or tests/examinations","Current drug or alcohol dependence","Currently intoxicated or under the acute effects of an illicit substance will not be consented into the study","Pregnant or nursing individuals or those who plan to become pregnant","Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including blood pressure, ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease","Clinically significant abnormal laboratory tests"],"whatHappens":"If you join, the listed intervention(s) are Magnetic Resonance Imaging scanner, 3T, NeurOptics PLRTM-3000 Pupillometer, or Experimental Anxiety Devices. The registry lists allocation as na. Background: There are no good treatments for people considering suicide.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 325 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.787Z"},{"nctId":"NCT02594202","title":"Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue","officialTitle":"Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nProstate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer. This will help them understand any changes in cells and genes. These changes might lead to the development and progression of prostate cancer. Researchers think the study could lead to new treatments.\n\nObjective:\n\nTo understand the changes in cells and genes that lead to the development and progression of prostate cancer. This could lead to new treatments.\n\nEligibility:\n\nMen ages 18 and older who have or are suspected to have prostate cancer\n\nDesign:\n\nParticipants will be screened with physical exam and medical history.\n\nParticipants will send tissue blocks of their tumor, if possible. If not, they will provide unstained slides of tumor tissue.\n\nParticipants may provide samples of blood, urine, saliva, and prostate secretions.\n\nParticipants may have imaging tests. They will lie in a machine that takes pictures of their body. These tests include:\n\nMRI of the prostate\n\nCT of the abdomen and pelvis\n\nChest x-ray\n\nParticipants may need a biopsy or surgery for treatment of their cancer. If so, researchers will collect tissue.\n\nParticipants may answer questions about their prostate cancer and quality of life.\n\nParticipants may have follow-up visits or other treatments. They may have follow-up phone calls every few months.\n\n...","conditions":["Prostate Cancer"],"keywords":["Specimen Collection","Carcinogenesis","Prognostic Biomarkers","Molecular Mechanims","Cell Lines","Natural History"],"interventions":[],"enrollment":3000,"startDate":"2015-12-21","completionDate":"2036-01-01","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Adults (greater than or equal to 18 years of age) with biopsy-proven or suspected prostate cancer (elevated PSA abnormal digital rectal exam (DRE) abnormal prostate MRI, or family history) who require and are willing to undergo diagnostic or therapeutic intervention as part of their diagnosis, standard of care treatment, or follow-up/surveillance for their neoplasm.\n  2. ECOG performance status of 0-2\n  3. Must be willing and able to provide informed consent\n  4. PSA \\> or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR\n  5. PSA \\> or equal to 2.5 ng/ml (for patients 50 years or older) OR\n  6. Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR\n  7. Abnormal prostate MRI finding OR\n  8. Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer\n\nEXCLUSION CRITERIA:\n\n1\\. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Karen K Holcomb","phone":"(240) 974-9026","email":"karen.holcomb@nih.gov"},{"name":"Peter A Pinto, M.D.","phone":"(240) 858-3700","email":"pp173u@nih.gov"}],"primaryOutcomes":["Collect samples for the purpose of studying the molecular mechanisms of carcinogenesis in prostate cancer"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Care of the Prostate Cancer Patient and Prospective Procurement of Prostate Cancer Tissue","inPlainEnglish":"Background: Prostate cancer is the most common noncutaneous cancer among men in the U.S. Researchers want to study blood, tissue, and fluid samples of people with prostate cancer.","whoItsFor":["Ages 18 Years to any","Men only","how well you can do daily activities (ECOG score) of 0-2","PSA \\> or equal to 1.0 ng/ml (for patients aged 30 - 49 years) OR","PSA \\> or equal to 2.5 ng/ml (for patients 50 years or older) OR","Abnormal DRE (i.e. enlarged, asymmetric, nodular, firm or tender) OR","Abnormal prostate MRI finding OR","Family history of first degree relatives (brother or father) with prostate cancer or first-degree relatives (mother or sister) with breast or ovarian cancer"],"whoShouldSkip":["1\\. Subjects whose comorbidities would preclude diagnostic or therapeutic intervention"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.314Z"},{"nctId":"NCT02595957","title":"Genomic Services Research Program","officialTitle":"Genomic Services Research Program","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Human Genome Research Institute (NHGRI)","sponsorClass":"NIH","summary":"Background:\n\nGenes are the instructions a person s body uses to function. Genome sequencing reads through all of a person s genes. Everyone has many gene variants, and most do not cause disease. Some gene variants called secondary findings may be important for a person s health even if they are not related to the reason why a person had genome sequencing done. Researchers want to learn more about what it means to have a secondary finding.\n\nObjectives:\n\nTo learn about how gene variants may affect a person s health.\n\nTo learn about how people understand their genetic test results.\n\nEligibility:\n\nPeople with secondary findings from genetic testing done as part of a research study, clinical care, or other methods.\n\nDesign:\n\nParticipants may be asked to do an online survey and phone interview to ask what they think about their results, their healthcare, and if they talk with their family about the result.\n\nEligible participants may be offered a visit to the NIH Clinical Center where they will be evaluated for health problems related to the secondary finding.\n\nDNA samples that were already collected may be studied.\n\nParticipants may be asked to send in a second DNA sample (blood or saliva). These will be used to verify any findings.\n\nParticipants who have a secondary finding can get genetic counseling.","conditions":["Colon Cancer","Breast Cancer"],"keywords":["Genome Sequencing","Secondary Findings","Return of Results","Natural History","Exome Sequencing"],"interventions":[],"enrollment":5000,"startDate":"2014-09-16","completionDate":"2099-12-31","sex":"ALL","minAge":"1 Month","maxAge":"105 Years","healthyVolunteers":false,"eligibilityRaw":"* ELIGIBILITY CRITERIA:\n\nWe employ a referral form through SurveyMonkey to receive referrals from recruitment partners or self-referrals. This serves as an intake form and self-reported eligibility review. This form asks for contact information, key information about the prospective participant s SF,\n\nand subjective understanding of their result.\n\nIf we conclude, based on a review of the SF and available personal and/or family history, that the pathogenicity of the SF is not at least likely pathogenic, that participant may be eligible for the survey, interview, and/or re-contact for future follow-up, but will not complete any other protocol procedures (such as cascade testing). If a participant is consented and information arises during the social and behavioral study procedures that lead study staff to believe the genetic result does not qualify as an SF, the participant will be\n\nconsidered a screen failure and will not continue with study procedures.\n\nWe plan to offer enrollment in this protocol to English- or Spanish-speaking recipients of SF. We do not have trained staff who can conduct the interviews in languages other than English and Spanish.\n\nIf a caregiver of a minor or adult who is unable to consent is enrolled as an index participant to complete the survey and interview on behalf of the SF recipient, they may also be eligible for cascade testing to relate presence of an SF-related phenotype in a family member with presence or absence of SF genotype.\n\n-We may enroll a child in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease (e.g., Wilson disease and familial hypercholesterolemia have childhood onset).\n\nWe will not enroll neonates (less than one month old).\n\n* We may enroll adults who are unable to consent (i.e., an individual who is impaired at the time of consent) in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease.\n* We may enroll women who are pregnant in this protocol and women who become pregnant during the study can continue their participation. We will not perform prenatal genetic testing.\n* NIH staff members are not prohibited from enrollment if they meet the study s eligibility criteria. The study team will make every effort to protect the confidentiality of the NIH staff member s health information, to minimize any pressure on or discomfort of the NIH staff\n\nmember and provide a copy of the NIH Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in NIH Research , before consent is obtained.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie C Sapp","phone":"(301) 435-2832","email":"sappj@mail.nih.gov"},{"name":"Leslie G Biesecker, M.D.","phone":"(301) 402-2041","email":"lesb@mail.nih.gov"}],"primaryOutcomes":["Health impacts of SF receipt","Adherence to medical recommendations","Family based positive predictive value","Responses and perceptions"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Genomic Services Research Program","inPlainEnglish":"Background: Genes are the instructions a person s body uses to function. Genome sequencing reads through all of a person s genes.","whoItsFor":["Ages 1 Month to 105 Years","ELIGIBILITY CRITERIA:","We employ a referral form through SurveyMonkey to receive referrals from recruitment partners or self-referrals. This serves as an intake form and self-reported eligibility review. This form asks for contact information, key information about the prospective participant s SF,","and subjective understanding of their result","considered a screen failure and will not continue with study procedures","We plan to offer enrollment in this protocol to English- or Spanish-speaking recipients of SF. We do not have trained staff who can conduct the interviews in languages other than English and Spanish","We may enroll a child in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease (e.g., Wilson disease and familial hypercholesterolemia have childhood onset)","We will not enroll neonates (less than one month old)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.973Z"},{"nctId":"NCT02617966","title":"Rod and Cone Mediated Function in Retinal Disease","officialTitle":"Rod and Cone Mediated Function in Retinal Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\nRetinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness. Researchers want to learn about rod and cone function in healthy people and people with retinal disease. They want to know if how well a person sees in the dark can test the severity of retinal disease.\n\nObjectives:\n\nTo find out if how well a person sees in the dark can test the severity of retinal disease. To find out if this can help detect retinal disease and track its changes.\n\nEligibility:\n\nPeople ages 5 and older with:\n\nRetinal disease OR\n\n20/20 vision or better with or without correction in at least one eye\n\nDesign:\n\nParticipants will be screened with medical and eye history and eye exam. Those with retinal disease will also have:\n\nEye imaging: Drops dilate the eye and pictures are taken of it.\n\nVisual field testing: Participants look into a bowl and press a button when they see light.\n\nElectroretinogram (ERG): An electrode is taped to the forehead. Participants sit in the\n\ndark with their eyes patched for 30 minutes. Then they get numbing drops and contact\n\nlenses. Participants watch lights while retina signals are recorded.\n\nVisit 1 will be 3-8 hours. Participants will have up to 6 more visits over 6-12 months. Visits include:\n\nEye exam and imaging\n\nTime course of dark adaptation: Participants view a background light for 5 minutes then\n\npush a button when they see colored light.\n\nDark adapted sensitivity: Participants sit in the dark for 45 minutes. They push a button when\n\nthey see colored light.\n\nFor participants with retinal disease, ERG and visual field testing\n\n...","conditions":["Retinal Degeneration","Retinitis Pigmentosa","Stargardt's Disease"],"keywords":["Retina","Retinal Degeneration","Retinitis Pigmentosa","Stargardt's Disease","Dark Adaptation"],"interventions":[],"enrollment":500,"startDate":"2016-03-24","completionDate":"2029-12-30","sex":"ALL","minAge":"5 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participant must be five years of age or older.\n* Participant (or legal guardian) must understand and sign the protocol s informed consent document.\n* Participant must be able to cooperate with the testing required for this study.\n\nFor Participants with retinal disease only:\n\n* Participant must have retinal disease, defined as evidence of loss of retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging.\n* Participant must have a measurable visual acuity.\n\nFor Healthy Volunteers only:\n\n-Participant must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one eye.\n\nEXCLUSION CRITERIA:\n\n-Participant with changes in pre-retinal media sufficient to obscure a view of the retina.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel W Claus, R.N.","phone":"(301) 451-1621","email":"daniel.claus@nih.gov"},{"name":"Brett G Jeffrey, Ph.D.","phone":"(301) 402-2391","email":"jeffreybg@mail.nih.gov"}],"primaryOutcomes":["The primary outcomes for this study are to establish normal ranges for the kinetics of dark adaptation and dark-adapted retinal sensitivity for the fundus guided and non-guided perimeters and for RF hyperacuity on the Display++."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Rod and Cone Mediated Function in Retinal Disease","inPlainEnglish":"Background: Retinal diseases cause the loss of rod and cone photoreceptors. Symptoms include vision loss and night blindness.","whoItsFor":["Ages 5 Years to 100 Years","Participant must be five years of age or older","Participant must be able to cooperate with the testing required for this study","For Participants with retinal disease only:","Participant must have retinal disease, defined as evidence of loss of retinal dysfunction and/or degeneration as established by standard clinical methods including perimetry, ERG and imaging","Participant must have a measurable visual acuity","For Healthy Volunteers only:","Participant must have visual acuity of 20/20 or better, with or without correction (e.g., glasses or contact lens) in at least one eye"],"whoShouldSkip":["Participant with changes in pre-retinal media sufficient to obscure a view of the retina"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.138Z"},{"nctId":"NCT02639325","title":"Tumor Related Epilepsy","officialTitle":"Tumor Related Epilepsy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nSome people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain tumor as possible without causing problems. Researchers think this may improve the outcome for people with brain tumors. It may completely relieve or greatly reduce the number of seizures they have.\n\nObjectives:\n\nTo evaluate people with brain tumors that are associated with seizures and to offer surgical treatment. Also, to study how surgery affects seizures.\n\nEligibility:\n\nPeople age 8 and older who have a brain tumor with associated seizures. They must be willing to have brain surgery to treat their epilepsy.\n\nDesign:\n\nParticipants will be screened with a review of their medical records.\n\nParticipants will have a medical history and physical exam.\n\nParticipants will be admitted to the hospital at NIH. They will have\n\nMedical history\n\nPhysical exam\n\nNeurological exam\n\nTests of memory, attention, and thinking\n\nQuestions about their symptoms and quality of life\n\nBlood drawn\n\nThey may also have:\n\nMRI or CT scan. They will lie on a table that slides in and out of a machine that takes pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.\n\nVideo electroencephalography monitoring. Electrodes will be placed on the scalp. The participant s brain waves will be recorded while doing normal activities. Participants will be videotaped.\n\nParticipants will keep a seizure diary before and after surgery.\n\nParticipants will have surgery to remove their brain tumor and the brain area where their seizures start.\n\nThey will stay in the hospital up to a week after surgery.\n\nParticipants have for follow-up visits at NIH.","conditions":["Epilepsy","Cancer","Brain Neoplasm"],"keywords":["Brain Tumor","Brain Cancer","Seizure Disorder","Seizures","Natural History"],"interventions":[],"enrollment":100,"startDate":"2016-01-26","completionDate":"2032-07-01","sex":"ALL","minAge":"8 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible for entry into the study, a candidate must meet all the following criteria:\n\n* Be 8 years of age or older.\n* Have solitary primary or recurrent brain tumor with associated seizures. Brain tumor may be diagnosed radiologically. Associated seizures are defined as those with activity starting within three months of radiologic diagnosis of the primary or recurrent tumor. In cases when the timing of seizure activity is unclear with respect to the timing of diagnosis, seizures will be considered associated with the tumor if seizure semiology is consistent with that location. Ongoing seizures are not required. Patients can be included if they have had a single previous seizure. Patients who have not experienced seizures after institution of anti-convulsant therapy are not excluded.\n\nEXCLUSION CRITERIA:\n\nCandidates will be excluded if they:\n\n-At the time of enrollment, lack consent capacity due to cognitive impairment that would make them incapable of understanding the explanation of the procedures in this study. Cognitive capacity to consent will be determined at the time of enrollment. Patients with mental disorders or those patients who are cognitively impaired yet still retain consent capacity will not be excluded. Children may be enrolled if there is a parent or guardian able to consent on their behalf.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gretchen C Scott, R.N.","phone":"(301) 496-2921","email":"SNBrecruiting@nih.gov"},{"name":"Kareem A Zaghloul, M.D.","phone":"(301) 594-8114","email":"zaghloulka@mail.nih.gov"}],"primaryOutcomes":["change in seizure frequency, as measured by the Engel scale"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Tumor Related Epilepsy","inPlainEnglish":"Background: Some people with brain tumors have seizures related to the tumor. Usually brain tumors are treated by removing as much of the brain tumor as possible without causing problems.","whoItsFor":["Ages 8 Years to 99 Years","To be eligible for entry into the study, a candidate must meet all the following criteria:","Be 8 years of age or older"],"whoShouldSkip":["Candidates will be excluded if they:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.900Z"},{"nctId":"NCT02649985","title":"PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases","officialTitle":"Microglial Activation PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Brigham and Women's Hospital","sponsorClass":"OTHER","summary":"The specific aims of the study are:\n\nPrimary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled \"Peripheral Benzodiazepine Receptor 06\" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls\n\nSecondary:\n\n1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy)\n2. A pilot substudy aims to establish the non-inferiority of \\[F-18\\]PBR06 as compared with Carbon-11 \\[C-11\\] labeled \"Peripheral Benzodiazepine Receptor 28\" (PBR28) PET in patients with RRMS.\n\nHypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities.\n\nIn addition, the investigators hypothesize that \\[F-18\\]PBR06-PET scans will be at least as good as \\[C-11\\]PBR28-PET scans, the current gold standard.","conditions":["Multiple Sclerosis","Alzheimer's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"[F-18]PBR06"},{"type":"DRUG","name":"[C-11]PBR28"}],"enrollment":250,"startDate":"2016-05-02","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male and female subjects age 18 to 70 years. For Alzheimer's Disease patients and healthy controls, the age range is going to be 18 to 85 years. This is because Alzheimer's disease subjects are usually older and it'd be difficult to recruit Alzheimer's patients who are younger than 70 years. Multiple Sclerosis, on the other hand, is a disease of a younger population.\n2. For RRMS, it needs to be active, which is defined as at least one relapse in the past 12 months, at least one gadolinium enhancing lesion on MRI within 12 months of enrollment or at least one new FLAIR bright lesion on MRI within 6 months of enrollment.\n3. For SPMS, deterioration in EDSS score in the last year is required.\n4. For the subjects in the Ocrelizumab arm, only the subjects who have already been prescribed Ocrelizumab by their treating MS neurologist but have not yet started the first infusion, will be included.\n5. For the Foralumab arm, patients enrolled in approved IRB protocols (2021P000105, 2022P000005, 2022P001075) will be enrolled.\n6. For the steroids arm, only subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment, will be included.\n7. AD subjects with MMSE score of 20-26.\n8. Subjects willing to undergo PET and MRI imaging\n9. Subjects willing and able to give informed consent\n\nExclusion Criteria:\n\n1. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.\n2. Individuals with bipolar disease and schizophrenia\n3. Concurrent medical conditions that contraindicate study procedures.\n4. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.\n5. Claustrophobia\n6. Non-MRI compatible implanted devices\n7. For the Ocrelizumab arm, subjects already on Ocrelizumab will be excluded. 8. For the steroids arm, subjects who have already started steroid treatment will be excluded.\n\n9\\. For the Ocrelizumab arm, steroids arm, and longitudinal arm, subjects with abnormal serum creatinine will be excluded.","locations":[{"facility":"Brigham MS Center, 60 Fenwood Road","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tarun Singhal, MD","phone":"617-264-3043","email":"tsinghal@bwh.harvard.edu"}],"primaryOutcomes":["Standardized uptake values (SUV)/Standardized uptake value ratios (SUVR)"],"hasResults":false,"conditionSlugs":["alzheimer","multiple-sclerosis","depression"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 1 / Phase 2: testing [F-18]PBR06 for Multiple Sclerosis","inPlainEnglish":"The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled \"Peripheral Benzodiazepine Receptor 06\" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.","whoItsFor":["Ages 18 Years to 85 Years","For RRMS, it needs to be active, which is defined as at least one relapse in the past 12 months, at least one gadolinium enhancing lesion on MRI within 12 months of enrollment or at least one new FLAIR bright lesion on MRI within 6 months of enrollment","For SPMS, deterioration in EDSS score in the last year is required","For the subjects in the Ocrelizumab arm, only the subjects who have already been prescribed Ocrelizumab by their treating MS neurologist but have not yet started the first infusion, will be included","For the Foralumab arm, patients enrolled in approved IRB protocols (2021P000105, 2022P000005, 2022P001075) will be enrolled","For the steroids arm, only subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment, will be included","AD subjects with MMSE score of 20-26","Subjects willing to undergo PET and MRI imaging"],"whoShouldSkip":["Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse","Individuals with bipolar disease and schizophrenia","Concurrent medical conditions that contraindicate study procedures","Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment","Non-MRI compatible implanted devices","For the Ocrelizumab arm, subjects already on Ocrelizumab will be excluded. 8. For the steroids arm, subjects who have already started steroid treatment will be excluded","9\\. For the Ocrelizumab arm, steroids arm, and longitudinal arm, subjects with abnormal serum creatinine will be excluded"],"whatHappens":"If you join, the listed intervention(s) are [F-18]PBR06, or [C-11]PBR28. The registry lists allocation as randomized. The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled \"Peripheral Benzodiazepine Receptor 06\" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 250 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.995Z"},{"nctId":"NCT02682667","title":"Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols","officialTitle":"Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nCancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S. Researchers want to study samples from people with cancer or a pre-malignant condition. They hope to develop more effective treatments.\n\nObjective:\n\nTo better understand the biology of malignancies and why certain cancers respond differently to treatment.\n\nEligibility:\n\nAdults at least 18 years old with cancer or a pre-cancerous condition.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests. Their diagnosis will be confirmed by the NCI Laboratory of Pathology.\n\nParticipants will send tissue blocks or slides from their original tumor biopsy.\n\nAt least once, participants will have a medical history, physical exam, and blood and urine tests.\n\nParticipants may have the following tests. They may have them more than once:\n\nApheresis. A needle in one arm removes blood. Blood is run through a machine and the sample cells are taken out. The rest of the blood is returned by a needle in the other arm.\n\nBone marrow aspiration and biopsy. The hipbone will be numbed. A needle will be put into the hipbone. Bone marrow will be taken out through the needle.\n\nPiece of cancer tissue taken by a needle and syringe.\n\nComputed tomography (CT) scan, magnetic resonance imaging (MRI) and/or positron emission tomography (PET) scan or ultrasound to help locate their tumor. For the scans, they lie in a machine that takes pictures.\n\nA small piece of skin removed.\n\nParticipants will be contacted by phone once a year to find out how they are doing.","conditions":["Multiple Myeloma","Lymphoma, Non-Hodgkin","Leukemia-Lymphoma, Adult T-Cell","Hodgkin Disease","Non-Small Cell Lung Cancer"],"keywords":["Apheresis Products","Immunological","Diverse Malignan","Premalignant","Protein","Natural History"],"interventions":[],"enrollment":500,"startDate":"2016-04-11","completionDate":"2030-12-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition\n  2. Age \\>=18 years of age\n  3. ECOG performance status of 0-3.\n\n  5\\. Ability and willingness of subject to provide informed consent\n\nAdditional inclusion criteria pertinent only for participants undergoing apheresis\n\n1. Hemoglobin \\>= 8 mg/dL and platelet count \\> 75 K/microL\n2. Weight \\>= 48 kg\n3. Central line in place or adequate venous access\n\nEXCLUSION CRITERIA:\n\n1. Active concomitant medical or psychological illnesses that may increase the risk to the subject.\n2. Inability to provide informed consent\n3. Pregnant or breastfeeding women","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Scott M Norberg, D.O.","phone":"(301) 275-9668","email":"scott.norberg@nih.gov"}],"primaryOutcomes":["Sample Acquisition"],"hasResults":false,"conditionSlugs":["lung-cancer","leukemia","lymphoma","multiple-myeloma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Biospecimen Procurement for Center for Immuno-Oncology Immunotherapy Protocols","inPlainEnglish":"Background: Cancer has a major impact in the United States and across the world. In 2015, over 1.5 million new cases of cancer were diagnosed in the U.S.","whoItsFor":["Ages 18 Years to 120 Years","Diagnosis of cancer, a premalignant/neoplastic condition or disease (such as an immunodeficiency) that increases the risk of being diagnosed with a cancer or premalignant/neoplastic condition","Age \\>=18 years of age","how well you can do daily activities (ECOG score) of 0-3","Additional who can join pertinent only for participants undergoing apheresis","Hemoglobin \\>= 8 mg/dL and platelet count \\> 75 K/microL","Central line in place or adequate venous access"],"whoShouldSkip":["Active concomitant medical or psychological illnesses that may increase the risk to the subject","Pregnant or breastfeeding women"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.839Z"},{"nctId":"NCT02719314","title":"Glucocorticoid-induced Osteoporosis in Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis","officialTitle":"Non-interventional Clinical Trial to Establish a Glucocorticoid-induced Osteoporosis Databank for Patients With Chronic Inflammatory Rheumatic Diseases or Psoriasis and Therapy With Glucocorticoids","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Prof Dr Frank Buttgereit","sponsorClass":"OTHER","summary":"Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time. The available data describing frequency and severity of these adverse effects are fragmentary. This statement is especially true for glucocorticoid-induced osteoporosis (GIOP) in the context of chronic inflammatory rheumatic diseases or (in part) psoriasis(arthritis). The state of knowledge and scientific data, being sparse, is partly conflicting and often derived from over-aged projects or studies. Therefore, there are urgent needs to work on various current questions systematically and at the highest scientific level possible. In order to address these needs, we aim at collecting and analyzing disease- and bone-related data from patients with chronic inflammatory rheumatic diseases or psoriasis and therapy with glucocorticoids, and to build a respective GIOP-Databank. Patients will attend for diagnostics, and where necessary therapy and follow-up of GIOP, according to current guidelines. Clinical, laboratory and instrumental examination results from more than 1000 patients in the first three years of the project are planned to be documented in a prospective database.","conditions":["Osteoporosis","Inflammatory Rheumatism"],"keywords":[],"interventions":[{"type":"DRUG","name":"Glucocorticoid treatment"}],"enrollment":10000,"startDate":"2015-12","completionDate":"2029-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nEvery patient has to fulfill the following inclusion criteria:\n\n* patients with (control group: without) a diagnosis of a chronic inflammatory rheumatic disease or psoriasis\n* patients who (not for control groups) have/had already a glucocorticoid therapy, or patients in which the implementation of a new long-term GC therapy is expected\n* patients who, according to the Dachverband Osteologie (DVO, Germany) guidelines, attend our osteoporosis and bone metabolism outpatient consultation hours or are referred by the hospital wards of the Charité for diagnosis, treatment or follow-up\n* capability to understand the patient information\n* consent to participation in the project and storage of data\n\nExclusion Criteria:\n\nIf any of the following exclusion criteria is true, the patient must not be included in this study:\n\n* alcohol, medication and/or drug addiction\n* severe psychiatric diseases limiting the comprehension of the project plan and the study protocol (persons incapable of giving informed consent)\n* pregnant and lactating patients\n* patients incapable of giving informed consent for any reason\n* prisoners and all persons who are committed to an institution due to an official or judicial order","locations":[{"facility":"Charité University Medicine Berlin (CCM)","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Frank Buttgereit, Prof Dr","phone":"+49 30 450 513125","email":"frank.buttgereit@charite.de"},{"name":"Edgar Wiebe, Dr","phone":"+49 30 450 513192","email":"gerd.burmester@charite.de"}],"primaryOutcomes":["Bone mineral density"],"hasResults":false,"conditionSlugs":["als","psoriasis"],"drugSlugs":[],"locationSlugs":["berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: testing Glucocorticoid treatment for Osteoporosis","inPlainEnglish":"Glucocorticoids remain to be among the most important and most frequently used anti-inflammatory and immunosuppressive or immune-modulatory acting drugs to treat rheumatic (and other) diseases. Unfortunately, glucocorticoids also exert undesired effects, especially if higher dosages have to be given over longer periods of time.","whoItsFor":["Ages 18 Years to any","Every patient has to fulfill the following who can join:","patients with (control group: without) a diagnosis of a chronic inflammatory rheumatic disease or psoriasis","patients who (not for control groups) have/had already a glucocorticoid therapy, or patients in which the implementation of a new long-term GC therapy is expected","patients who, according to the Dachverband Osteologie (DVO, Germany) guidelines, attend our osteoporosis and bone metabolism outpatient consultation hours or are referred by the hospital wards of the Charité for diagnosis, treatment or follow-up","capability to understand the patient information","consent to participation in the project and storage of data"],"whoShouldSkip":["If any of the following"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 10,000 people at Berlin. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.579Z"},{"nctId":"NCT02771236","title":"Clinical and Molecular Studies in Families With Inherited Eye Disease","officialTitle":"Clinical and Molecular Studies in Families With Inherited Eye Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\nGenes are the basic units of heredity. When genes are changed, certain cells don t work like they should. Researchers want to try to better understand the genetic conditions that are linked with inherited eye diseases.\n\nObjective:\n\nTo try to identify the genes linked to the development of inherited eye diseases.\n\nEligibility:\n\nPeople ages 4 and older who have or have a family member with an inherited eye disease\n\nDesign:\n\nParticipants will be screened with medical history and medical records.\n\nParticipants will have one visit that will take 3-4 hours. This will include:\n\nMedical and family history\n\nEye exam: This includes the pupil being dilated.\n\nElectroretinography: A small electrode is taped to the forehead. Participants sit in the\n\ndark with their eyes patched for 30 minutes. Then numbing drops and contact lenses are put in\n\nthe eyes. They will watch flashing lights.\n\nBlood tests\n\nSaliva sample: They will spit into a container or have the inside of their cheek swabbed.\n\nGenetic testing will be done on participants blood or saliva.\n\nParticipants may meet with the researchers to discuss their genetic tests.\n\n...","conditions":["Inherited Eye Disease"],"keywords":["Genetics","Natural History"],"interventions":[],"enrollment":5000,"startDate":"2016-10-04","completionDate":"2032-01-01","sex":"ALL","minAge":"4 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible, the following inclusion criteria must be met, where applicable;\n\n1. Participant must be four years of age or older.\n2. Participant must understand and sign the protocol s informed consent document.\n3. Individuals or family members of individuals with inherited eye diseases, either congenital, childhood, or age related.\n4. All participants must be able to cooperate with study examination and phlebotomy.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present:\n\n1. Participant has a disease, infection, or trauma that mimics inherited cataracts, retinal degenerations, glaucoma, etc.\n2. Participant has a significant active infection (an infection requiring treatment as determined by the investigator) or a history of chronic or recurrent infections.\n3. Participant requires sedation for study purposes.","locations":[{"facility":"University of California, San Diego","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Eye Center","city":"Durham","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Eye Research Institute, Zhongshan Ophthalmic Center, Sun Yat Sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aravind Medical Research Foundation","city":"Madurai","state":"","country":"India","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Seconda Universita di Napoli","city":"Naples","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Centre of Excellence in Molecular Biology, University of the Punjab","city":"Lahore","state":"","country":"Pakistan","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of the Philippines","city":"Manila","state":"","country":"Philippines","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Filatov Institute of Eye Disease and Tissue Therapy of the National Academy","city":"Odesa","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Exeter","city":"Exeter","state":"","country":"United Kingdom","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[{"name":"James F Hejtmancik, M.D.","phone":"(301) 435-1598","email":"f3h@helix.nih.gov"}],"primaryOutcomes":["Document the clinical and genetic features of Mendelian and age related visual disorders"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["la-jolla-california","bethesda-maryland","durham-north-carolina","guangzhou-china","madurai-india","naples-italy","lahore-pakistan","manila-philippines","odesa-ukraine","exeter-united-kingdom"],"enrichment":{"headline":"Clinical and Molecular Studies in Families With Inherited Eye Disease","inPlainEnglish":"Background: Genes are the basic units of heredity. When genes are changed, certain cells don t work like they should.","whoItsFor":["Ages 4 Years to 120 Years","To be eligible, the following who can join must be met, where applicable;","Participant must be four years of age or older","Individuals or family members of individuals with inherited eye diseases, either congenital, childhood, or age related","All participants must be able to cooperate with study examination and phlebotomy"],"whoShouldSkip":["A participant is not eligible if any of the following"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.635Z"},{"nctId":"NCT02824822","title":"Genetic Markers of Cardiovascular Disease in Epilepsy","officialTitle":"Genetic Markers of Cardiovascular Diseases and the Potential Role in Sudden Unexpected Death in Epilepsy.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age. The exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. Some of these conditions which affect heart and brain have an identifiable genetic cause. This study aims to identify known genetic causes of heart rhythm and sudden death related disorders in patients with epilepsy.","conditions":["Epilepsy","Seizures","Syncope","Channelopathy","Cardiomyopathies"],"keywords":["Sudden Unexpected Death in Epilepsy","SUDEP","Sudden Cardiac Arrest","Sudden Cardiac Death","Sleep","Ion channel disease","Long QT syndrome","Brugada","Catecholaminergic Polymorphic Ventricular Tachycardia"],"interventions":[],"enrollment":600,"startDate":"2016-05","completionDate":"2031-12","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ages 18 - 50 with a diagnosis of epilepsy or seizures, or syncope or drowning or cardiac arrest or sudden death or an abnormal ECG suggestive of an arrhythmia\n* Blood-relatives (Aged 18+) of a patient with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning, syncope or arrhythmia\n\nExclusion Criteria:\n\n* Those who are unable to provide written consent.\n* Prisoners (vulnerable population)\n* Seizures secondary to ischemic events\n* Traumatic brain injury resulting in seizures\n* History of cranial surgery\n* History of brain tumor","locations":[{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Somers CPL Lab","phone":"","email":"CPL@mayo.edu"}],"primaryOutcomes":["Using Next Generation Whole-Exome Sequencing, determine if an underlying genetic cardiac mutation is present in refractory epilepsy patients who are at highest risk of sudden death."],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Genetic Markers of Cardiovascular Disease in Epilepsy","inPlainEnglish":"Epilepsy is a common condition which affects over 3 million people in the US. Patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (SUDEP) of 35%, which is greatest in those under 40 years of age.","whoItsFor":["Ages 18 Years to 50 Years","Adults ages 18 - 50 with a diagnosis of epilepsy or seizures, or syncope or drowning or cardiac arrest or sudden death or an abnormal ECG suggestive of an arrhythmia","Blood-relatives (Aged 18+) of a patient with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning, syncope or arrhythmia"],"whoShouldSkip":["Prisoners (vulnerable population)","Seizures secondary to ischemic events","Traumatic brain injury resulting in seizures","History of cranial surgery","History of brain tumor"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 600 people at Rochester. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.904Z"},{"nctId":"NCT02877303","title":"Blinatumomab, Inotuzumab Ozogamicin, and Combination Chemotherapy as Frontline Therapy in Treating Patients With B Acute Lymphoblastic Leukemia","officialTitle":"Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.","conditions":["B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Blinatumomab"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Cytarabine"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Doxorubicin Hydrochloride"},{"type":"BIOLOGICAL","name":"Inotuzumab Ozogamicin"},{"type":"OTHER","name":"Laboratory Biomarker Analysis"},{"type":"DRUG","name":"Mercaptopurine"},{"type":"DRUG","name":"Methotrexate"},{"type":"BIOLOGICAL","name":"Ofatumumab"},{"type":"DRUG","name":"Prednisone"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"DRUG","name":"Vincristine Sulfate"}],"enrollment":80,"startDate":"2016-11-01","completionDate":"2026-11-01","sex":"ALL","minAge":"14 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with newly diagnosed, previously untreated B-lineage ALL or lymphoblastic lymphoma, or having achieved complete remission (CR) with one course of induction chemotherapy; patients who require steroids, cytarabine (ara-c) or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible\n* Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible\n* Performance status of 0-3\n* Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)\n* Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)\n* Adequate cardiac function as assessed by history and physical examination\n* No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Known to be human immunodeficiency virus (HIV)-positive\n* Philadelphia chromosome (Ph)-positive ALL\n* Active and uncontrolled disease/infection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n* Unable or unwilling to sign the consent form\n* Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per treating physician assessment), sources for the determination of clinical significance by the treating physician will be included in the subject's medical record\n* History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; (Patients with CNS involvement of leukemia are NOT excluded)\n* Current autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences/manifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar disease, or psychosis","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elias Jabbour","phone":"713-792-4764","email":"ejabbour@mdanderson.org"}],"primaryOutcomes":["Relapse-free survival (RFS)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":["ofatumumab"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Blinatumomab for B Acute Lymphoblastic Leukemia","inPlainEnglish":"This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 14 Years to any","Failure to one induction course of chemotherapy (these patients will be analyzed separately); patients who require steroids, ara-c or hydrea to manage disease symptoms prior to finalization of diagnosis and treatment plan are allowed and eligible","Performance status of 0-3","Creatinine less than or equal to 2.0 mg/dL (unless considered tumor related)","Bilirubin less than or equal to 2.0 mg/dL (unless considered tumor related)","Adequate cardiac function as assessed by history and physical examination","No active or co-existing malignancy with life expectancy less than 12 months, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record"],"whoShouldSkip":["Pregnant or nursing women","Known to be human immunodeficiency virus (HIV)-positive","Philadelphia chromosome (Ph)-positive ALL","Active and uncontrolled disease/infection as judged by the treating physician, sources for the determination of clinical significance by the treating physician will be included in the subject's medical record","Unable or unwilling to sign the consent form","Current autoimmune disease or history of autoimmune disease with potential CNS involvement; auto-immune disease with possible CNS consequences/manifestations such as such as epilepsy, paresis, aphasia, stroke, dementia, Parkinson's disease, cerebellar disease, or psychosis"],"whatHappens":"If you join, the listed intervention(s) are Blinatumomab, Cyclophosphamide, or Cytarabine. The registry lists allocation as na. This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.275Z"},{"nctId":"NCT02896335","title":"Palbociclib and Pembrolizumab In Central Nervous System Metastases","officialTitle":"Phase II Trial of Palbociclib and Pembrolizumab in Central Nervous System Metastases","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This research study is studying This research study is studying the efficacy and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases:\n\n* Palbociclib alone (Cohort 1)\n* The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.","conditions":["Metastatic Malignant Neoplasm to Brain","Recurrent Brain Metastases","Progressive Brain Metastases"],"keywords":["Recurrent Brain metastases","Progressive Brain Metastases","Recurrent brain metastases from breast cancer","central nervous system metastases","recurrent brain metastases from melanoma"],"interventions":[{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":45,"startDate":"2017-02-02","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1)\n* Participants must have histologically or cytologically confirmed disease from breast cancer or melanoma (Cohort 2).\n* Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm.\n* Participants must have progressive CNS lesions, as defined by one of the following:\n\n  * Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eligible if they have one or more un-treated (by surgery or SRS) progressive lesions that is measurable.\n  * Patients have measurable residual or progressive lesions after surgery.\n  * Patients who have had prior WBRT and/or SRS are eligible but there needs to be unequivocal evidence of progression of at least one lesion treated by radiation (e.g. tissue diagnosis). Biopsy can be considered for definitive diagnosis.\n  * Patients who have previously been treated with systemic therapy for CNS metastases are eligible.\n* Age \\> 18 years. The toxicity of palbociclib in children is unknown.\n* ECOG performance status of 0, 1 or 2 (Karnofsky ≥ 60, see Appendix A).\n* Participants must have normal organ and marrow function as defined below:\n\n  * leukocytes ≥3,000/mcL\n  * absolute neutrophil count ≥1,500/mcL\n  * platelets ≥100,000/mcL\n  * hemoglobin ≥9g/dL\n  * total bilirubin \\< 1.5 x institutional upper limit of normal OR \\> 1.5 x institutional upper limit of normal allowed if direct bilirubin is within normal range.\n  * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal\n  * creatinine within normal institutional limits OR\n\n    * creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (Cohort 1)\n    * creatinine clearance ≥30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (Cohort 2)\n  * baseline QTc \\<480ms\n* The effects of palbociclib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of palbociclib administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Tissue from a prior biopsy or resection of intracranial or extracranial site (primary or metastatic site) for clinical genetic sequencing (at least one FFPE block or 15 unstained slides). Patients previously assessed for genetic sequencing who meet requirements of section 9.2.1 do not need to have additional tissue available for prospective genetic screening.\n* Presence of alteration in CDK pathway in any biopsy or resection (amplifications in CDK4, CDK6, CCND1, CCND2, CCND3 or CCNE1 or loss of CDKN2A) as described in Section 9.2 using a CLIA-certified assay (Cohort 1 only).\n* Patients with progressive extracranial disease will not be excluded.\n* Stable dose of corticosteroids for at least 7 days.\n* Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks, and have undetectable HBV viral load prior to enrollment\n\n  * Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention\n  * Hepatits B screening tests are not required unless:\n\n    * Known history of HBV infection\n    * As mandated by local health authority\n* Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\n  * Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to enrollment\n  * Heptatits C screening tests are not required unless:\n\n    * Known history of HCV infection\n    * As mandated by local health authority\n\nExclusion Criteria\n\n* Prior treatment with CDK4/6 inhibitor.\n* Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have ≥ grade 2 adverse events due to agents administered more than 2 weeks earlier.\n* Participants who are receiving any other investigational agents.\n* Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, or ovarian suppression therapy)\n* Leptomeningeal involvement of cancer (Cohort 1). Leptomeningeal involvement is allowed for Cohort 2.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib (including abemaciclib).\n* Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A isoenzymes are ineligible. Lists including medications and substances known or with the potential to interact with the CYP3A isoenzymes are provided in Appendix C, and can also be found within section 5.4. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with palbociclib, breastfeeding should be discontinued if the mother is treated with palbociclib.\n\nIf a participant inadvertently becomes pregnant while on treatment with pembrolizumab, the participant will be immediately discontinued from study intervention(s). The site will contact the participant at least monthly and document the participant's status until the pregnancy has been completed or terminated. The outcome of the pregnancy will be reported to Merck within 2 working days if the outcome is a serious adverse experience (e.g. death, abortion, congenital anomaly, or other disabling or life-threatening complication to the mother or newborn). The study Investigator will make every effort to obtain permission to follow the outcome of the pregnancy and report the condition of the fetus or newborn to Merck. If a male participant impregnates his female partner, the study personnel at the site must be informed immediately and the pregnancy must be reported to the Overall PI, Merck and Pfizer and followed as necessary.\n\n* HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with palbociclib. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated (Cohort 1). In Cohort 2, HIV-positive patients will NOT be permitted.\n* Current use of drugs that are known to prolong the QT interval (See Appendix C).\n* Unable to undergo MRI scans.\n* QTc \\> 480 msec (based on the mean value of the triplicate ECGs), family or personal history of long or short QTc prolongation, or Torsade de Pointes (TdP).\n* Uncontrolled electrolyte disorders that can compound the effects of QTc-prolonging drug (eg. hypocalcemia, hypokalemia, hypomagnesemia).\n* Active auto immune disease (Cohort 2)\n* Patients with history of lung radiation (Cohort 2)\n* Prior treatment with PD-1 or PD-L1 blocking agent (Cohort 2)\n* History of allogenic transplant\n* History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* History of Hepatitis B or known active Hepatitis C virus infection","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nancy Wang, MD, MPH","phone":"617-724-8770","email":"Nwang6@mgb.org"}],"primaryOutcomes":["Intracranial Clinical Benefit Rate (Cohort 1)","Intracranial Clinical Benefit Rate (Cohort 2)"],"hasResults":false,"conditionSlugs":["breast-cancer","melanoma"],"drugSlugs":["pembrolizumab","palbociclib"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: testing Palbociclib for Metastatic Malignant Neoplasm to Brain","inPlainEnglish":"This research study is studying This research study is studying the how well it works and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases: * Palbociclib alone (Cohort 1) * The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.","whoItsFor":["Ages 18 Years to any","Participants must have histologically or cytologically confirmed disease from any solid tumor (Cohort 1)","Participants must have histologically or cytologically confirmed disease from breast cancer or melanoma (Cohort 2)","Participants must have measurable disease in the CNS, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm","Participants must have progressive CNS lesions, as defined by one of the following:","Patients may have multiple progressive CNS lesions, some of which have been treated by SRS or surgery. Patients are eligible if they have one or more un-treated (by surgery or SRS) progressive lesions that is measurable","Patients have measurable residual or progressive lesions after surgery","Patients who have had prior WBRT and/or SRS are eligible but there needs to be unequivocal evidence of progression of at least one lesion treated by radiation (e.g. tissue diagnosis). Biopsy can be considered for definitive diagnosis"],"whoShouldSkip":["Prior treatment with CDK4/6 inhibitor","Participants who have had chemotherapy, immunotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have ≥ grade 2 side effects due to agents administered more than 2 weeks earlier","Participants who are receiving any other investigational agents","Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, or ovarian suppression therapy)","Leptomeningeal involvement of cancer (Cohort 1). Leptomeningeal involvement is allowed for Cohort 2","History of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib (including abemaciclib)","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements"],"whatHappens":"If you join, the listed intervention(s) are Palbociclib, or Pembrolizumab. The registry lists allocation as randomized. This research study is studying This research study is studying the how well it works and safety of the following study drugs as a possible treatment for recurrent central nervous system (CNS) metastases: * Palbociclib alone (Cohort 1) * The combination of palbociclib and pembrolizumab (Cohort 2) Pfizer and Merck, pharmaceutical companies, are supporting this research study by providing the study drugs as well as funding for research activities.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 45 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.731Z"},{"nctId":"NCT02969798","title":"Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)","officialTitle":"Preservation of Beta Cell Function in Pre-diabetes in Subject With Impaired Fasting Glucose (IFG) and Impaired Glucose Tolerance (IGT)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The University of Texas Health Science Center at San Antonio","sponsorClass":"OTHER","summary":"HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.","conditions":["Diabetes Mellitus, Type 2","Impaired Glucose Tolerance (IGT)","Impaired Fasting Glucose (IFG)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dapagliflozin"},{"type":"DRUG","name":"Saxagliptin"},{"type":"DRUG","name":"Pioglitazone"},{"type":"DRUG","name":"Metformin"}],"enrollment":700,"startDate":"2014-01-01","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and BMI to IGT and IFG subjects\n\n  1. Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening.\n  2. FPG \\< 100 mg/dl and 2-h PG \\< 140 mg/dl\n  3. BMI = 24-40 kg/m2;\n  4. Stable body weight (±4lbs) over the preceding 3 months\n  5. Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data\n  6. Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):\n\n     * Oral contraceptive\n     * Injectable progesterone\n     * Subdermal implant\n     * Spermicidal foam/gel/film/cream/suppository\n     * Diaphragm with spermicide\n     * Copper or hormonal containing IUD\n     * Sterile male partner vasectomized \\> 6 month pre-dosing.\n  7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n  8. Subjects must be willing and able to comply with scheduled visits, treatment, laboratory tests and study procedures.\n\nExclusion Criteria:\n\n1. Recent (i.e., within three (3) months prior to Screening) evidence or medical history of unstable concurrent disease such as: documented evidence or history of clinically significant hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, immunological, or clinically significant neurological disease.\n2. Subjects with a family history of diabetes in a first degree relative\n3. BMI of less than 24 or greater than 40 kg/m2\n4. Unstable body weight (change of greater than ±4lbs over the preceding 3 months\n5. Subjects participating in an excessively heavy exercise program\n6. Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule\n7. Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded.\n8. Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data\n9. Pregnant subjects or subjects unwilling to use birth control during their study enrollment\n10. Blood donation of approximately 1 pint (500 mL) within 8 weeks prior to Screening.\n11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study\n12. Subjects with hematuria will be excluded.\n13. Subjects with evidence or prior history of heart failure will be excluded\n14. Subjects with family history of pancreatic, bladder, and breast cancer will be excluded.\n15. Subjects with history of pancreatitis will be excluded.\n16. Subjects with eGFR \\< 60 ±5 ml/min.1.73m2 will be excluded.\n17. Subjects with elevated serum creatinine (\\>1.5 mg/dl males/1.4 mg/dl females) will be excluded.\n18. Subjects with a history of orthostatic hypotension (\\>15/10 mmHg) will be excluded.\n19. Subjects with liver enzymes (ALT, AST) \\>3-fold above upper normal limit will be excluded.\n20. Subjects with a history of hypersensitivity to pioglitazone, dapagliflozin, or Saxagliptin will be excluded.","locations":[{"facility":"The University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ralph A DeFronzo, MD","phone":"210-567-6691","email":"defronzo@uthscsa.edu"},{"name":"Monica Palomo, BS","phone":"210-567-6710","email":"palomom@uthscsa.edu"}],"primaryOutcomes":["Beta cell function","Insulin sensitivity","Glucose tolerance status"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":["dapagliflozin"],"locationSlugs":["san-antonio-texas"],"enrichment":{"headline":"Not a traditional drug phase: testing Dapagliflozin for Diabetes Mellitus, Type 2","inPlainEnglish":"HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.","whoItsFor":["Ages 18 Years to 65 Years","NGT subjects will serve as controls and will be matched in age, gender, ethnicity, and body-mass index (BMI) to IGT and IFG subjects","Male or female subjects between the ages of 18 and 65 years of age, inclusive, at Screening","FPG \\< 100 mg/dl and 2-h PG \\< 140 mg/dl","Stable body weight (±4lbs) over the preceding 3 months","Subjects with no evidence of major organ system disease as determined by physical exam, history, and screening laboratory data","Females of childbearing potential with a negative pregnancy test at Screening and Treatment visits, using one of the following forms of contraception for the duration of participation in the study (i.e., until Follow-up 7-14 days post last dose):","Injectable progesterone"],"whoShouldSkip":["Subjects with a family history of diabetes in a first degree relative","body-mass index (BMI) of less than 24 or greater than 40 kg/m2","Unstable body weight (change of greater than ±4lbs over the preceding 3 months","Subjects participating in an excessively heavy exercise program","Subject with a feeding/sleeping schedule different from a daytime feeding/night time sleeping schedule","Subjects taking medications known to alter glucose metabolism (with the exception of metformin and/or pioglitazone) or which effect brain neurosynaptic function are excluded","Subjects with evidence of major organ system disease as determined by physical exam, history, and screening laboratory data"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin, Saxagliptin, or Pioglitazone. The registry lists allocation as randomized. HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 700 people at San Antonio. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.971Z"},{"nctId":"NCT03025074","title":"Blood Collection Biorepository for Liver Disease Research","officialTitle":"Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"State University of New York at Buffalo","sponsorClass":"OTHER","summary":"The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.","conditions":["Non-Alcoholic Steatohepatitis(NASH)","Hepatitis C","Hepatitis B","Fibrosis","Cirrhosis","Fatty Liver","Obesity, Childhood","Bariatric Surgery Candidate"],"keywords":["Liver Disease","Obesity","Hepatitis","HIV","Hepatology"],"interventions":[],"enrollment":1000,"startDate":"2013-07","completionDate":"2099-12","sex":"ALL","minAge":"7 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.\n* Children and teenagers will be special populations considered in this protocol.\n\nExclusion Criteria:\n\n* Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.","locations":[{"facility":"University at Buffalo, Buffalo General Medical Center","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Barbara Bauer, BA","phone":"716-888-4825","email":"bmbauer@buffalo.edu"}],"primaryOutcomes":["Number of samples collected"],"hasResults":false,"conditionSlugs":["obesity","hiv"],"drugSlugs":[],"locationSlugs":["buffalo-new-york"],"enrichment":{"headline":"Blood Collection Biorepository for Liver Disease Research","inPlainEnglish":"The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.","whoItsFor":["Ages 7 Years to any","This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples","Children and teenagers will be special populations considered in this protocol"],"whoShouldSkip":["Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Buffalo. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.162Z"},{"nctId":"NCT03065335","title":"Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder","officialTitle":"Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nMost medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments. One dose of ketamine has a rapid antidepressant effect. For most people, this lasts a week or less. Repeated doses of ketamine may help maintain this effect.\n\nObjective:\n\nMain Study: To study the effects of ketamine in treating depression.\n\nKetamine Metabolites Substudy: To study how ketamine effects brain chemistry.\n\nTo study how ketamine effects the brain. This is done by looking at metabolites, which are created when a drug is broken down.\n\nEligibility:\n\nMain Study: People ages 18-65 with major depressive disorder and healthy volunteers\n\nKetamine Metabolites Substudy: Healthy volunteers ages 18-65\n\nDesign:\n\nMain Study:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 phases totaling 14-20 weeks.\n\nPhase I (2-7 weeks):\n\n* Gradually stop current medications\n* MRI: Participants lie and perform tasks in a machine that takes pictures of the body.\n* Mood and thinking tests\n* Blood and urine tests\n* Sleep test: Monitors on the skin record brain waves, breathing, heart rate, and movement during sleep.\n* Transcranial magnetic stimulation: A coil on the scalp gives an electrical current that affects brain activity.\n* Stress tests: Electrodes on the skin measure reactions to loud noises or electric shocks.\n\nPhase I tests are repeated in Phases II and III and in the final visit.\n\nPhase II (4-5 weeks):\n\n* 4 weekly IV infusions of ketamine or a placebo during an MRI or MEG. For the MEG, a cone over the head records brain activity.\n\nPhase III (optional):\n\n* 8 infusions of ketamine over 4 weeks\n\nPhase IV (optional):\n\n* Symptoms monitoring for 4 weeks\n* Participants will have a final visit. They will be offered standard treatment at NIH for up to 2 months.\n\nKetamine Metabolites Substudy:\n\nParticipants will be screened in another study, with:\n\n* Medical and psychiatric history\n* Psychiatric and physical exam\n* Blood, urine, and heart tests\n\nParticipants will be inpatients at NIH for 4 days.\n\nStudy Procedures:\n\nMood and thinking tests\n\nBlood and urine tests\n\n1 infusion of ketamine\n\nSpinal tap and spinal catheter: Used to get samples of cerebrospinal fluid (CSF). This is a fluid that moves around and within the brain and spinal cord. Studying CSF will help us learn how ketamine effects brain chemistry","conditions":["Healthy Volunteer","Major Depressive Disorder","Depression"],"keywords":["Magnetic Resonance Imaging","Magnetoencephalography","Major Depressive Disorder","Ketamine","Neuropharmacology"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"OTHER","name":"Placebo"},{"type":"DEVICE","name":"Cobot TS MV robotic arm for TMS"},{"type":"DEVICE","name":"NeurOptics PLRTM-30000 Pupillometer"}],"enrollment":150,"startDate":"2017-05-25","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion Criteria: All Subjects (Main Study)\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\" or protocol 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized\n\nAdditional Inclusion Criteria: Patients with MDD (Main Study)\n\n1. At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.\n2. At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \\>= 20 and YMRS of \\< 12.\n3. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.\n\nKetamine Metabolites Substudy Inclusion Criteria: Healthy Volunteers\n\n1. 18 to 65 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under either protocol 01-M-0254 \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\") or 17-M-0181 (\"Recruitment and Characterization of Research Volunteers for NIMH Intramural Studies\").\n4. Agree to be hospitalized.\n\nEXCLUSION CRITERIA:\n\nAdditional Exclusion Criteria: Patients with MDD (Main Study)\n\n1. Current diagnosis of Bipolar Disorder including Bipolar I, Bipolar II, or Bipolar NOS diagnoses.\n2. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n3. Subjects with a history of DSM-IV or DSM-5 drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) urine test at screening.\n4. Treatment with a reversible MAOI within two weeks prior to Phase II.\n5. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n\nExclusion Criteria: All Subjects (Main Study)\n\n1. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to MRI and infusion of ketamine.\n2. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n3. Clinically significant abnormal laboratory tests.\n4. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures.\n5. Treatment with any other concomitant medication 14 days prior to Phase II. An exception of this would be necessary for those who are taking Fluoxetine or Aripiprazole. Prior to Phase II, treatment with Fluoxetine must be discontinued for at least 5 weeks and treatment with Aripiprazole must be discontinued for at least 3 weeks.\n6. Any use of opioid medication in the past 3 months\n7. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing imaging component of the study only).\n8. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.\n9. Subjects who have hearing loss that has been clinically evaluated and diagnosed\n10. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects doing imaging component of the study only).\n11. Positive HIV test\n12. Weight \\> 119 kg\n13. \\[for participants undergoing NPU Threat Test with Auditory Startle\\] Known history of hearing loss\n\nAdditional Exclusion Criteria: Healthy Volunteers (Main Study)\n\n1\\. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n\nKetamine Metabolites Substudy Exclusion Criteria: Healthy Volunteers\n\n1. Current or past history of any DSM-IV or DSM-5 Axis I disorder based on clinical assessment and confirmed by a structured diagnostic interview (SCID).\n2. Current (within the past 3 months) or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine)\n3. Pregnant or nursing women or women who plan to become pregnant. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the 4-days of the study participation (or until last clinical labs and rating) and have a negative pregnancy test that was obtained no more than 24 hours prior to infusion of ketamine.\n4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n5. Clinically significant abnormal laboratory tests.\n6. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.\n7. Treatment with any other concomitant medication.\n8. Any use of opioid medication in the past 3 months\n9. Positive HIV test\n10. Weight \\> 119 kg\n11. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip) (for subjects doing neuroimaging component of the study only).\n12. Participants who are uncomfortable in small closed spaces (have claustrophobia), unable to lie comfortably supine for up to 90 minutes, and would feel uncomfortable in the MRI machine (for subjects requiring clinical MRI scans for safety and/or structural MRI scans for MEG coregistration).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Adilah M Kirton","phone":"(301) 549-0315","email":"adilah.meredith-kirton@nih.gov"}],"primaryOutcomes":["To demonstrate more robust neuropharmacodynamic effects measured by neuropharmacodynamic imaging (fMRI+EEG and MEG) of ketamine 0.5 mg/kg as compared to placebo administered over 40 minutes.","Ketamine Metabolites Substudy: To determine if ketamine metabolites cross the blood brain barrier and enter the brain during ketamine IV administration."],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Ketamine for Healthy Volunteer","inPlainEnglish":"Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments.","whoItsFor":["Ages 18 Years to 65 Years","who can join: All Subjects (Main Study)","18 to 65 years of age","Agree to be hospitalized","Additional who can join: Patients with major depression (Main Study)","At the initial study enrollment, subjects must have fulfilled DSM-IV or DSM-5 criteria for Major Depression, single episode or recurrent. Subjects must be experiencing a current major depressive episode of at least 2 weeks duration","At the initial screening and beginning of Phases II and III, subjects must have a baseline score on the MADRS \\>= 20 and YMRS of \\< 12","Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Ketamine, Placebo, or Cobot TS MV robotic arm for TMS. The registry lists allocation as randomized. Background: Most medications that treat depression take weeks or months to work.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 150 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.105Z"},{"nctId":"NCT03093909","title":"Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases","officialTitle":"Phase I Study of Aerosol Gemcitabine in Patients With Solid Tumors and Pulmonary Metastases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"Any time the words \"you,\" \"your,\" \"I,\" or \"me\" appear, it is meant to apply to the potential participant.\n\nThe goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.\n\nThe safety and side effects of this drug will also be studied.\n\nThis is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic and lung cancer, and other solid tumors. Its administration by inhalation is investigational. The study doctor can explain how the study drug is designed to work.\n\nUp to 44 participants will be enrolled in this study. All will take part at MD Anderson.","conditions":["Malignant Neoplasm of Bone and Articular Cartilage","Malignant Neoplasms of Female Genital Organs","Malignant Neoplasms of Independent (Primary) Multiple Sites","Malignant Neoplasms of Lip Oral Cavity and Pharynx","Malignant Neoplasm of Male Genital Organs","Malignant Neoplasms of Mesothelial and Soft Tissue","Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma","Malignant Neoplasms of Thyroid and Other Endocrine Glands","Malignant Neoplasms of Urinary Tract","Melanoma and Other Malignant Neoplasms of Skin"],"keywords":["Solid Tumors and Pulmonary Metastases","aerosol gemcitabine","aerosol GCB","Lung metastases","osteosarcoma"],"interventions":[{"type":"DRUG","name":"Gemcitabine"}],"enrollment":44,"startDate":"2017-11-22","completionDate":"2027-11-30","sex":"ALL","minAge":"12 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life.\n2. Willing to comply with protocol therapy and required safety monitoring (self-report, pulse oximetry, remote spirometry, labs).\n3. Adequate organ function as defined by: peripheral absolute neutrophil count (ANC) \\>/= 1,000/mm3, platelet count \\>/= 100,000/mm3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment), hemoglobin \\>/= 8.0g/dl (may receive RBC transfusions), renal-creatinine \\</= 2 x ULN; hepatic- bilirubin and AST \\</= 5x ULN; pulmonary: FVC \\>/=50% predicted, Oxyhemoglobin saturation at rest \\>/=95% (off supplemental oxygen).\n4. Patient age \\>/= 12 years and \\</= 50 years.\n5. Performance Status: ECOG \\</= 2 for patients \\>/= 16 years old or Lansky play \\>/= 60% for patients \\</=15 years old.\n6. Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \\</= 1 or to the baseline laboratory values as defined in the inclusion criteria.\n7. No radiotherapy within 2 weeks.\n8. Subjects who received GCB systemically previously are eligible for participation.\n\nExclusion Criteria:\n\n1. Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it.\n2. Pregnant or breastfeeding women will not be entered into this study due to risks of fetal and teratogenic adverse events as seen in animal studies. Pregnancy tests must be obtained in females who are post-menarchal and of child bearing potential (e.g. female that has not been amenorrheic for at least 12 consecutive months or surgically sterilized). Males or females of reproductive potential will not participate unless they have agreed to use effective contraception for the entire period in which they are receiving protocol therapy and for at least one month after treatment ends. Effective contraception is defined as intrauterine device (IUD), hormonal (birth control pill, injections, implants, patch), tubal ligation and partner's vasectomy. Abstinence is an acceptable method of birth control.\n3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, bradycardia, related to cardiac disease, bundle branch block, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n4. Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \\>/= 2 (CTCAE v4.0).\n5. Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy.\n6. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE Grade \\</= 1 with the exception of alopecia and laboratory values listed per the inclusion criteria. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by the investigational product may be included (eg, hearing loss).","locations":[{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Najat C. Daw-Bitar, MD","phone":"713-792-3280","email":"ndaw@mdanderson.org"}],"primaryOutcomes":["Maximum Tolerated Dose (MTD) Recommended for Phase 2 Dose of Aerosol Gemcitabine (GCB)","Toxicities of Aerosol Gemcitabine (GCB)"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","als"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: testing Gemcitabine for Malignant Neoplasm of Bone and Articular Cartilage","inPlainEnglish":"Any time the words \"you,\" \"your,\" \"I,\" or \"me\" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.","whoItsFor":["Ages 12 Years to 50 Years","Patients with diagnosis of solid tumor with lung metastases and patient's current disease state must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life","Patient age \\>/= 12 years and \\</= 50 years","Performance Status: ECOG \\</= 2 for patients \\>/= 16 years old or Lansky play \\>/= 60% for patients \\</=15 years old","Patients must have resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to NCI CTCAE Grade \\</= 1 or to the baseline laboratory values as defined in the who can join","No radiotherapy within 2 weeks","Subjects who received GCB systemically previously are eligible for participation"],"whoShouldSkip":["Currently being treated with bronchodilators or corticosteroids or known to have active asthma. This will not include patients who suffered from asthma as a child and outgrew it","Subjects with baseline symptoms of fever and/or cough and/or shortness of breath and/or wheezing and/or fatigue grade \\>/= 2 (CTCAE v4.0)","Patients receiving other concurrent cancer therapy including chemotherapy, immunotherapy, or biologic therapy"],"whatHappens":"If you join, the listed intervention(s) are Gemcitabine. The registry lists allocation as na. Any time the words \"you,\" \"your,\" \"I,\" or \"me\" appear, it is meant to apply to the potential participant.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 44 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.740Z"},{"nctId":"NCT03136146","title":"Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia","officialTitle":"Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.","conditions":["Recurrent Acute Lymphoblastic Leukemia","Recurrent Adult Lymphoblastic Lymphoma","Recurrent Burkitt Leukemia","Recurrent Burkitt Lymphoma","Recurrent Childhood Lymphoblastic Lymphoma","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Acute Lymphoblastic Leukemia","Refractory Burkitt Leukemia","Refractory Burkitt Lymphoma","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory Lymphoblastic Lymphoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Bortezomib"},{"type":"DRUG","name":"Clofarabine"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Etoposide"},{"type":"BIOLOGICAL","name":"Ofatumumab"},{"type":"BIOLOGICAL","name":"Pegfilgrastim"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"DRUG","name":"Vincristine Sulfate Liposome"}],"enrollment":42,"startDate":"2017-08-09","completionDate":"2027-08-01","sex":"ALL","minAge":"15 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):\n\n  * Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)\n  * Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or \"double-hit\" leukemia/lymphoma (phase II only)\n* At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset\n* Age older than 15 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 3 (There may be certain patients with performance status \\[PS\\] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)\n* Serum bilirubin =\\< 1.5 mg/dL\n* Serum glutamate pyruvate transaminase (SGPT) =\\< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome\n* Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL/min\n* Signed informed consent\n\nExclusion Criteria:\n\n* Active \\>= grade 3 peripheral neuropathy\n* Active hepatic graft-versus-host disease\n* Known positivity for hepatitis B or C\n* Pregnancy\n* Breast feeding","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of adverse events","Overall response rate (ORR) (Phase II)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":["ofatumumab"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Bortezomib for Recurrent Acute Lymphoblastic Leukemia","inPlainEnglish":"This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.","whoItsFor":["Ages 15 Years to any","Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):","Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)","Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or \"double-hit\" leukemia/lymphoma (phase II only)","Age older than 15 years","Serum bilirubin =\\< 1.5 mg/dL","Serum glutamate pyruvate transaminase (SGPT) =\\< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome","Estimated creatinine clearance or GFR (glomerular filtration rate) \\>= 50 mL/min"],"whoShouldSkip":["Active \\>= grade 3 peripheral neuropathy","Active hepatic graft-versus-host disease","Known positivity for hepatitis B or C"],"whatHappens":"If you join, the listed intervention(s) are Bortezomib, Clofarabine, or Cyclophosphamide. The registry lists allocation as na. This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 42 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.270Z"},{"nctId":"NCT03167437","title":"An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab","officialTitle":"An Open-Label, Proof of Concept Study of Vorinostat for the Treatment of Moderate-to-Severe Crohn's Disease, Ulcerative Colitis, and Chronic Granulomatous Disease Colitis Patients and Maintenance Therapy With Ustekinumab","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nCrohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition. CD has no cure, but symptoms can sometimes be controlled with medicine. Researchers want to see if it is safe to treat CD with the medicine vorinostat. It is thought that vorinostat may reduce the inflammation process of CD. This may then help to relieve symptoms of CD. Participants who respond to Vorinostat will be invited to an extension phase of treatment with Vorinostat and possibly a maintenance treatment using Ustekinumab.\n\nObjectives:\n\nTo see if vorinostat is safe for people with moderate-to-severe CD. To see if it is safe for people with moderate-to-sever CD to receive maintenance therapy using Ustekinumab after successful treatment of Vorinostat.\n\nEligibility:\n\nAdults 18-65 with moderate-to-severe CD that medicine is not controlling.\n\nDesign:\n\nPhase I is screening. It may last 120 days. Participants will have:\n\nPhysical exam\n\nMedical history\n\nTests of blood, urine, and stool samples\n\nHeart test\n\nQuestionnaires\n\nTuberculosis skin test\n\nThey may have a colonoscopy and lymphapheresis collection. These will be explained in a separate consent.\n\nThey will keep a diary of symptoms.\n\nPhase II is treatment using Vorinostat. It will take 12-13 weeks. Participants will take the study drug by mouth twice daily for 12 weeks. They will get a weekly phone call to talk about how the drug makes them feel. They will have blood taken regularly. Every 4 weeks, they will have a check-up that will repeat some screening tests.\n\nPhase III extension treatment of Vorinostat for an additional 6 months for those who respond to vorinostat and it is safe for them to continue treatment. Participants will continue to receive weekly calls to talk about how the drug makes them feel. They will have blood taken regularly. Every 3 months, they will have a check-up that will repeat some screening tests.\n\nPhase IV: is maintenance therapy for 2 years with Ustekinumab. Participants will receive a one time loading dose of ustekinumab, and then will receive the approved maintenance dose once every 8 weeks, at which time they will return to the NIH Clinical Center for evaluation. The participant will get a phone call 3 days after each dose and again 2 weeks later to see how the drug makes them feel. After two years of receiving treatment with ustekinumab the participant will have an end of study visit, where some of the screening tests, including a colonoscopy, will be repeated.","conditions":["Crohn's Disease"],"keywords":["Reduce Symptoms of Crohn's Disease","HDAC Inhibitors"],"interventions":[{"type":"DRUG","name":"Vorinostat"},{"type":"DRUG","name":"Ustekinumab"}],"enrollment":35,"startDate":"2017-10-30","completionDate":"2035-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIndividuals with moderate-to-severe CD, UC, and CGD colitis who are not controlled by and refractory to standard therapy will be eligible for inclusion into this study if they meet the following criteria:\n\n1. Are 18 to 65 years of age, inclusive, at enrollment date.\n2. Have a diagnosis of CD, UC, or CGD colitis that has been endoscopically or radiographically confirmed. A colonoscopy will be required at baseline to document mucosal disease activity. SES-CD for CD and CGD colitis will be obtained with minimum score of 7 and MES for UC patients will be obtained with minimum score of 2.\n3. Have active CD symptoms as defined by a CDAI score between 220 and 350, UC symptoms defined by a Mayo score of 6 to 10 (moderate) or 10 to 12 (severe), or CGD colitis symptoms defined as an HBI score of 8-16 (moderate) or \\> 16 (severe), and demonstrate active symptoms as defined by continued weight loss, abdominal pain and/or diarrhea not controlled by standard therapy.\n4. The participant must have active CD and UC symptoms (as noted above) and therefore have had an inadequate response to, loss of response to, or intolerance to at least 1 of the following agent groups in control of their disease (as defined below for each individual agent group: Corticosteroids or Immunomodulators or TNF-alpha antagonists or Anti-integrin antibodies or JAK inhibitors or IL-12p19 (IL-23) antagonists). No specific induction therapy or long-term treatment for CGD colitis patients has been defined; therefore all symptomatic patients will be evaluated for inclusion on individual basis.\n\n   a. Corticosteroids\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone \\>=30 mg PO once daily (QD) for 2 weeks or intravenously (IV) for 1 week OR\n\n   ii. One failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg PO QD or to taper to below a dose of 9 mg of budesonide\n\n   OR\n\n   iii. History of intolerance of corticosteroids at the discretion of the principal investigator (PI) (including but not limited to Cushing s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, or infection)\n\n   b. Immunomodulators\n\n   i. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (AZA) (\\>= 2.5 mg/kg/Day) or 6-MP (\\>= 1.5 mg/kg/Day) OR\n\n   ii. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of MTX (\\>= 25 mg/week) OR\n\n   iii. History of intolerance of at least one immunomodulator (including but not limited to nausea/vomiting leading to discontinuation, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine methyltransferase genetic mutation, or serious infection)\n\n   c. TNF-alpha antagonists with signs and symptoms of persistently active disease despite a history of receiving infliximab, adalimumab, or certolizumab at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and/or lupus-like rash.\n\n   d. Anti-integrin antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-integrin antibody agent (natalizumab or vedolizumab) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and/or lupus-like reaction.\n\n   e. JAK inhibitor:\n\n   with signs and symptoms of persistently active disease despite a history of receiving a JAK inhibitor (tofacitinib and ruxolitinib) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and/or lupus-like reaction.\n\n   f. Anti-IL-12 p19 (IL-23) antibodies:\n\n   with signs and symptoms of persistently active disease despite a history of receiving an anti-IL-12p19 (IL-23) antibody agent (Skyrizi and Tremfya) at a dose approved for the treatment of CD or UC and:\n\n   i. Patient had an inadequate response after completing the full induction regimen, per approved product labeling\n\n   ii. Responded initially but then lost response with continued therapy\n\n   iii. Patient had a significant adverse event response which precluded further use including but not exclusion of infusion reaction, serum sickness and/or lupus-like reaction.\n5. At the discretion of the PI, concomitant medications will be permitted if the following conditions are met prior to baseline assessment (Day-1):\n\n   a. 5-aminosalicylic acid (ASA)-based compounds are permissible if:\n\n   i. Oral 5-ASA-based compounds must be at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Recently discontinued oral 5-ASA-based compounds must have been discontinued at least 3 weeks prior to baseline or\n\n   iii. Rectal 5-ASA-based compounds are not permissible during the study and must have been discontinued at least 3 weeks prior to baseline.\n\n   b. Corticosteroids (e.g., prednisone, budesonide) are permissible if:\n\n   i. Oral corticosteroids must be at a prednisone-equivalent dose of \\<= 40 mg/day, or 9 mg/day of budesonide, and have been at a stable dose for at least 3 weeks prior to baseline or\n\n   ii. Discontinuation of oral corticosteroids must have been completed at least\n\n3 weeks prior to baseline or\n\niii. Parenteral (subcutaneous, intramuscular, or IV) or rectal corticosteroids are not permitted during the study and must not have been used within a 3- week period prior to baseline\n\nc. CD, UC, or CGD colitis-specific antibiotics are permissible if using an antibiotic for treatment of CD,UC, or CGD colitis (i.e., metronidazole, ciprofloxacin, rifaximin, ampicillin, sulfonamide and tetracycline)\n\ni. Participants must have been using the antibiotic for at least 3 weeks before baseline at a stable dose or\n\nii. If not currently using a CD, UC, or CGD colitis-specific antibiotic, the stop date must have been at least 3 weeks prior to baseline.\n\nd. Immunomodulators are permissible if:\n\ni. Participants receiving chronic (i.e., \\>= 12 weeks) treatment with AZA, 6- MP, or MTX prior to baseline must be on a stable dose for at least 6-8 weeks prior to baseline and must continue on this same dose during the study. OR\n\nii. Participants who have discontinued therapy with AZA, 6-MP, or MTX must have stopped the medication at least 4 weeks prior to baseline. OR\n\niii. Participants must not have received therapy with other known immunomodulators (e.g. cyclosporine, tacrolimus, sirolimus, pentoxifylline, or mycophenolate mofetil) or experimental agents (e.g. granulocyte- or macrophage colony stimulating factor) for at least 8 weeks or 5 half-lives of agent from baseline, whichever is longer.\n\ne. The use of Anti-TNF, Anti-integrin, JAK inhibitors, Anti-IL-12p19 (IL-23) therapy or other biological therapy listed below will not be permitted and the following washout period will be required in order for participant to be eligible:\n\ni. Three months washout prior to baseline for certolizumab or natalizumab.\n\nii. Two months washout prior to baseline for adalimumab, infliximab, and vedolizumab, tofacitinib, ruxolitinib, Skyrizi and Tremfya.\n\niii. 8-week washout prior to baseline for cyclosporine, pimecrolimus, tacrolimus, and any other systemic immunosuppressant.\n\n6\\. Participants must have a primary medical care provider.\n\n7\\. Male participants must agree to employ birth control measures to prevent pregnancy in female partners from start of treatment and continuing through 3 months post treatment.\n\n8\\. Females of childbearing potential must not be breast-feeding, possibly or actually pregnant, must not have had unprotected intercourse for one month prior to dosing, and must agree not to become pregnant beginning from enrollment in the study to at least 6 months after the end of treatment. Participants must remain completely abstinent of potentially reproductive sexual intercourse (e.g. due to a committed lifestyle) or to consistently use BOTH a barrier method with a spermicide (male or female condom) AND ALSO one of the below listed methods of birth control:\n\n1. Continuous/daily hormonal methods including oral contraceptive pills, patch, implant/injection, etc.\n2. Surgical sterilization of either partner, of sufficient duration to be effective, and NOT known to have failed.\n3. Intrauterine device.\n\n   EXCLUSION CRITERIA:\n\n   Individuals who meet ANY of the following criteria will be excluded from participation in this\n\n   study:\n   1. Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract infection) within three months of screening.\n   2. History or presence of recurrent or chronic infection (e.g., viral infection \\[including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV)\\], bacterial infection, systemic fungal infection, or syphilis).\n   3. Positive for tuberculosis (TB) via QuantiFERON-Gold (QFT-G). Individuals who are known to have received the tuberculosis vaccine will be administered the QFT-G. Patients cannot have received tuberculosis vaccine within 12 months prior to start of study and cannot receive tuberculosis vaccine while on study or within 12 months from the time of conclusion of study participation.\n   4. Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic HBV, HCV, HIV, or opportunistic infections.\n   5. A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant.\n   6. At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the last 30-days of the screening window.\n   7. Presence of abnormal hematological and biochemical parameters, including:\n\n      * Neutrophil count \\< 1500 cells/mm3\n      * Hemoglobin \\< 9 g/dL\n      * Platelet count \\<= 150,000 cells/mm3\n      * Creatinine \\>= 1.2 times the upper limit of normal (ULN)\n      * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\>= 1.5 times\n\n      ULN\n      * Prothrombin time-international normalized ratio (PT-INR) \\> 1.0 ULN\n      * Serum bilirubin level \\> 1.0 times ULN\n   8. Individuals on chronic anticoagulation medications.\n   9. Stool sample positive for GI pathogens potentially causing disease (as assessed by FilmArray GI panel for 22 viral, bacterial, and parasitic organisms that can cause infectious diarrhea \\[GI pathogen panel\\]). The principal investigator will consult with an infectious disease specialist to review results and decide whether treatment is warranted.\n   10. Presence of cytomegalovirus (CMV) infection as defined by positive immunohistochemical staining on tissue intestine biopsy.\n   11. History of low-grade or high-grade colonic mucosal dysplasia.\n   12. History of bowel surgery other than perianal (e.g., fistulotomy, seton placement, or abscess drainage) within 6 months prior to beginning the CDAI screening diary, Mayo scoring, or Harvey Bradshaw index or drawing screening blood samples.\n   13. Presence of surgical changes to gut anatomy that preclude administration of clinical activity indices; this includes but is not limited to ileostomy, colostomy, or subtotal colectomy with ileorectal anastomosis.\n   14. Known or suspected short bowel syndrome.\n   15. Requirement of parenteral, total parenteral, elemental oral, or nasogastric nutrition.\n   16. History or current evidence of cancer, other than non-melanomatous cancer of the skin, or participants that have undergone excision of basal cell carcinoma, squamous cell carcinoma of the skin. All patients receiving ustekinumab will be monitored for the appearance of non-melanoma skin cancer. Patients greater than 60 years of age, those with a medical history of prolonged immunosuppressant therapy and those with a history of PUVA treatment will be followed closely.\n   17. Unwillingness or inability to comply with study requirements.\n   18. Presence of only small bowel disease that is inaccessible by standard colonoscopy for harvest of research biopsies. Individuals with only upper gastrointestinal disease or only perianal fistulizing disease are also excluded for this reason.\n   19. Refusal to abstain from using COX-2 inhibitors or non-steroidal anti-inflammatory drugs (NSAIDs) throughout the study agent administration period.\n   20. Has uncontrolled diabetes\n   21. Is taking anti-seizure medication, such as valproic acid or its derivative (i.e., Depakote).\n   22. Presence of any condition that, in the opinion of the principal investigator, contraindicates participation in this study.\n   23. Has participated in another investigational trial within 8 weeks (or 5 half-lives of any investigational study agent), whichever is greater, prior to the pre-trial (screening) visit. The window will be derived from the last date of treatment on the previous trial.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ivan J Fuss, M.D.","phone":"(301) 761-7091","email":"ifuss@niaid.nih.gov"}],"primaryOutcomes":["To evaluate the safety and tolerability of vorinostat in patients with moderate to severe CD as measured by the rate, frequency, and severity of adverse events (AEs) after 12 weeks of treatment."],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Vorinostat for Crohn's Disease","inPlainEnglish":"Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.","whoItsFor":["Ages 18 Years to 65 Years","Individuals with moderate-to-severe CD, UC, and CGD colitis who are not controlled by and refractory to standard therapy will be eligible for inclusion into this study if they meet the following criteria:","Are 18 to 65 years of age, inclusive, at enrollment date","i. Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone \\>=30 mg PO once daily (QD) for 2 weeks or intravenously (IV) for 1 week OR","ii. One failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg PO QD or to taper to below a dose of 9 mg of budesonide","iii. History of intolerance of corticosteroids at the discretion of the principal investigator (PI) (including but not limited to Cushing s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, or infection)","b. Immunomodulators","ii. Signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of MTX (\\>= 25 mg/week) OR"],"whoShouldSkip":["Individuals who meet ANY of the following criteria will be excluded from participation in this","Presence of clinically significant systemic infection (e.g., chronic or acute infection, urinary tract infection, or upper respiratory tract infection) within three months of screening","History or presence of recurrent or chronic infection (e.g., viral infection \\[including hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV)\\], bacterial infection, systemic fungal infection, or syphilis)","Has a history of active tuberculosis (TB) or a chest x-ray (CXR) with findings suggestive of old TB infection including calcified nodular lesions, apical fibrosis, or pleural scarring), acute or chronic HBV, HCV, HIV, or opportunistic infections","A conduction abnormality on baseline electrocardiogram (ECG) that in the opinion of a cardiologist, is deemed significant","At the discretion of the principal investigator, off-label use of any small molecule therapeutics that are immune modulators (e.g., naltrexone) within 90 days of beginning screening or at any time during the last 30-days of the screening window","Presence of abnormal hematological and biochemical parameters, including:"],"whatHappens":"If you join, the listed intervention(s) are Vorinostat, or Ustekinumab. The registry lists allocation as randomized. Background: Crohn s disease (CD) is an inflammatory bowel disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.899Z"},{"nctId":"NCT03190928","title":"Clonal Evolution in Follicular Lymphoma","officialTitle":"Prospective Study of Clonal Evolution in Follicular Lymphoma","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nFollicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research. They help scientists better understand differences in the cancer biology of different patients. Researchers want to collect serial samples over time from people with follicular lymphoma to help them design future treatments.\n\nObjective:\n\nTo collect a variety of samples from people with follicular lymphoma to study how these diseases progress and respond to treatment.\n\nEligibility:\n\nAdults at least 18 years old who have been diagnosed with, but have not yet had any treatment for, follicular lymphoma.\n\nDesign:\n\nParticipants will be screened with medical history and physical exam. They will answer questions about daily functioning. They will have blood and urine tests. They may have scans and have tissue samples taken.\n\nParticipants will be monitored about every 4 months for up to 2 years. They will repeat screening tests. They will have a cheek swab. A small brush will be rubbed against the inside of the cheek to wipe off some cells.\n\nParticipants will have imaging scans about every 8 months for up to 2 years.\n\nParticipants may have a bone marrow aspiration and biopsy. The hipbone will be numbed with a small needle.\n\nA needle will be put into the hipbone, and about 2 tablespoons of bone marrow will be taken out through the needle.\n\nParticipants will continue being monitored every 6 months for up to 5 years, then 1 time a year.","conditions":["Follicular Lymphoma"],"keywords":["Disease Monitoring","Molecular Monitoring","Novel Biomarker Identification","Gene Expression Analyses","Watchful-Waiting","Natural History"],"interventions":[],"enrollment":200,"startDate":"2017-07-27","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; individuals who meet criteria for immediate initiation of systemic therapy are eligible\n* Adequate tissue available from original diagnostic biopsy.\n\nNOTE: If biopsy was \\>12 months prior to enrollment OR adequate tissue is not available, tissue biopsy may be optionally repeated unless such a biopsy is considered unacceptable risk to the individual. Individuals without adequate tissue are eligible at the discretion of the PI.\n\n\\- Must have disease that is measurable or evaluable on either computed tomography (CT) scans or FDG-positron emission tomography (FDG-PET) scans\n\nNOTE: Since individuals with FL may have lesions that wax and wane on imaging, the requirement for disease being measurable or evaluable can come from imaging taken at any time at or after diagnosis, the most recent imaging prior to enrollment does not need to show measurable or evaluable disease.\n\n\\- Age greater than or equal to 18 years\n\nNOTE: Individuals with the pediatric-type follicular lymphoma are usually \\<18 years of age, and often have a very different clinical course than individuals with the adult-type of FL. Due to this difference in biology, children are excluded from this study.\n\n\\- ECOG performance status \\<2 (Karnofsky \\>60%)\n\nEXCLUSION CRITERIA:\n\n* Previous history of diffuse large B-cell lymphoma or histologic transformation\n* Any prior systemic treatment for lymphoma including cytotoxic chemotherapy, biologic therapy, and monoclonal antibody therapy (radiotherapy permitted); individuals who have received chemotherapy, biologic therapy, hormonal therapy, or monoclonal antibody for other malignancies are potentially eligible provided that all of the following are true: a) that malignancy was not lymphoma, b) systemic therapy ended at least 3 years prior to the diagnosis of FL, and c) there is no evidence of active malignancy other than FL\n\nNOTE: Initiation of first-line systemic therapy is allowed while on this trial; concurrent participation in first-line treatment clinical trials will be permitted.\n\n* Individuals who are HIV-positive\n* Any second malignancy that requires active systemic therapy\n* Any other (non-lymphoma) life-threatening disease\n* Individuals unable to provide informed consent (surrogates will not be used)\n* Pregnant women are excluded from enrollment onto this study because the invasive procedures and/or sedation needed to perform them may cause unnecessary harm to the unborn fetus. In the event a woman becomes pregnant while on study, she will not be removed from the study; however, no follow-up invasive clinical or research procedures will be done that include unacceptable to risk to the participant and/or to the unborn fetus.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Medical Oncology Referral Office","phone":"(240) 760-6050","email":"ncimo_referrals@nih.gov"},{"name":"Rahul Lakhotia, M.D.","phone":"(240) 858-7242","email":"rahul.lakhotia@nih.gov"}],"primaryOutcomes":["Characteristics of treatment received (e.g., type, response, etc.) and molecular biology (e.g., pathology, histologic transformation) will be described","Time to initiation of first-line systemic treatment (TTT1), defined as the number of days from study enrollment until the date of initiation of first-line systemic treatment"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Clonal Evolution in Follicular Lymphoma","inPlainEnglish":"Background: Follicular lymphoma is a type of cancer of the lymph nodes. Lab studies are important for cancer research.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed follicular lymphoma (FL), grades 1-2, or 3a confirmed by the Laboratory of Pathology, NCI; individuals who meet criteria for immediate initiation of systemic therapy are eligible","Adequate tissue available from original diagnostic biopsy","NOTE: If biopsy was \\>12 months prior to enrollment OR adequate tissue is not available, tissue biopsy may be optionally repeated unless such a biopsy is considered unacceptable risk to the individual. Individuals without adequate tissue are eligible at the discretion of the PI","\\- Must have disease that is measurable or evaluable on either computed tomography (CT) scans or FDG-positron emission tomography (FDG-PET) scans","\\- Age greater than or equal to 18 years","NOTE: Individuals with the pediatric-type follicular lymphoma are usually \\<18 years of age, and often have a very different clinical course than individuals with the adult-type of FL. Due to this difference in biology, children are excluded from this study","\\- how well you can do daily activities (ECOG score) \\<2 (Karnofsky \\>60%)"],"whoShouldSkip":["Previous history of diffuse large B-cell lymphoma or histologic transformation","NOTE: Initiation of first-line systemic therapy is allowed while on this trial; concurrent participation in first-line treatment clinical trials will be permitted","Individuals who are HIV-positive","Any second malignancy that requires active systemic therapy","Any other (non-lymphoma) life-threatening disease"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.159Z"},{"nctId":"NCT03191149","title":"Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change","officialTitle":"Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","conditions":["Advanced Lung Non-Small Cell Carcinoma","Recurrent Lung Non-Small Cell Carcinoma","Stage IIIB Lung Non-Small Cell Cancer AJCC v7","Stage IV Lung Non-Small Cell Cancer AJCC v7"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography with Contrast"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":46,"startDate":"2018-04-25","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)\n* Participants must have advanced disease - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 7th edition staging criteria\n* An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay\n\n  * NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports\n* Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration\n* Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed\n* Participants must not have previously received osimertinib\n* Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 1\n* Hemoglobin \\>= 9.0 g/L (within 4 weeks before registration)\n* Leukocytes/white blood cells \\>= 3,000/mcL (within 4 weeks before registration)\n* Absolute neutrophil count \\>= 1,500/mcL (within 4 weeks before registration)\n* Platelets \\>= 100,000/mcL (within 4 weeks before registration)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) if no liver metastases or =\\< 3 times ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases (within 4 weeks before registration)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 3 x institutional upper limit of normal; for patients with known hepatic metastases AST and/or ALT =\\< 5 x ULN (within 4 weeks before registration)\n* Creatinine =\\< 1.5 x institutional upper limit of normal (within 4 weeks before registration)\n* Participants may not have clinically active or symptomatic interstitial lung disease or interstitial pneumonitis (i.e., affecting activities of daily living or requiring therapeutic intervention), or a history of clinically significant interstitial lung disease or radiation pneumonitis\n* Participants may not have had radiation to the lung fields within four weeks (28 days) of starting treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or other sites where the radiation field includes the lungs, radiation must be completed at least two weeks before starting treatment. For all palliative radiation to all other sites, at least 7 days must have elapsed prior to starting treatment. At least six months (180 days) must have elapsed prior to starting treatment for radiation given with curative intent. Palliative radiotherapy to control symptoms (including gamma knife technique) is permitted. For stereotactic radiosurgery (SRS) to central nervous system (CNS) lesions, osimertinib can be held on the day of radiation only. For palliative radiotherapy (RT) to other sites of disease outside of the thorax osimertinib (osi) should be held for a minimum of 3 days before radiation and 3 days after RT is completed, but the duration of washout can be adjusted at the investigator's discretion with the approval of the study principal investigator (PI). For thoracic radiation, a 7-10 day washout period before the procedure and one week period after procedure before restarting osimertinib is advised to minimize the risk of pneumonitis. All radiotherapy related toxicities should be managed and ideally resolved before restarting osimertinib. Investigators should consider the radiotherapy when assessing causality if there are any localized adverse events (AEs) following the procedure\n* Participants may not have clinically symptomatic brain metastases, leptomeningeal disease, or spinal cord compression. Patients may be on a stable dose of corticosteroids to control brain metastases if they have been on a stable dose for two weeks (14 days) prior to study treatment and are clinically asymptomatic\n* Patients must have an ECHO or a nuclear study (MUGA or first pass) within 4 weeks (28 days) prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \\< institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \\>= 50% for the patient to be eligible\n* Participants may not have any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\>= 470 msec obtained from 3 electrocardiograms (ECGs) using the screening clinic ECG machine-derived QTc value\n  * No history of QT prolongation associated with other medications that required discontinuation of that medication\n  * Patient must not be receiving any concomitant medications that are known to be associated with Torsades de Pointes\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g., complete left bundle branch block, third degree heart block, second degree heart block, any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: serum/plasma potassium \\< LLN; serum/plasma magnesium \\< LLN; serum/plasma calcium \\< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval\n  * Symptomatic heart failure - New York Heart Association (NYHA) grade II-IV\n* Participants may not have a second, clinically active, cancer. Patients with second cancers which have been treated with curative intent and/or are currently inactive are allowed\n* Participants may not be receiving any other investigational agents. Patients previously treated with investigational agents must complete a washout period of at least two weeks or five half-lives, whichever is longer, before starting treatment\n* Participants may not have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Patients must have no history of hypersensitivity active or inactive excipients of osimertinib (AZD9291) or drugs with a similar chemical structure or class to osimertinib (AZD9291)\n* Patients must not currently be receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (at least 3 week prior). All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4\n* If medically feasible, patients taking regular medication, with the exception of potent inducers of CYP3A4, should be maintained on it throughout the study period. Patients taking concomitant medications whose disposition is dependent upon breast cancer resistance protein (BCRP) or P-glycoprotein (Pgp) and which have a narrow therapeutic index should be closely monitored for signs of changed tolerability as a result of increased exposure of the concomitant medication whilst receiving osimertinib (AZD9291)\n\n  * NOTE: Use of St John's wort is a contra-indication for osimertinib (AZD9291) use\n* If applicable, it is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by AZD9291 \\[osimertinib\\]) should be as low as possible and should be guided by the statin label. Monitoring of low-density lipoprotein (LDL) cholesterol levels is advised. If the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken\n* Subjects taking warfarin should be monitored regularly for changes in prothrombin time or international normalized ratio (INR)\n* No unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2, prior platinum-therapy-related neuropathy\n* Patients with refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib (AZD9291) are ineligible\n* Women must not be pregnant or breast-feeding because osimertinib (AZD9291) has been shown to cause fetal harm in animal models. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Women of childbearing potential (WOCBP) and sexually active males must use an accepted and effective method of contraception while receiving protocol treatment or abstain from sexual intercourse for the duration of their participation in the study. WOCBP must use birth control for two weeks prior to the start of the treatment and continue for 6 weeks after the last dose of the study drug. Sexually active male patients must use effective contraception from day 1 of treatment and continue for 4 months after the last dose of the study drug\n* Other anticancer agents and investigational agents should not be given while the subject is on study treatment\n* Supportive care and other medications that are considered necessary for the subject's wellbeing may be given at the discretion of the investigator\n* A guidance regarding potential interactions with concomitant medications is provided","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United 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States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Mary Regional Cancer Center","city":"Walla Walla","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Providence Regional Cancer System-Yelm","city":"Yelm","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Southern Lakes VLCC","city":"Burlington","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinic-Chippewa Center","city":"Chippewa Falls","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Saint Luke's South Shore","city":"Cudahy","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-EC Cancer Center","city":"Eau Claire","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Health Center-Fond du Lac","city":"Fond du Lac","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Health Care Germantown Health Center","city":"Germantown","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Grafton","city":"Grafton","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora BayCare Medical Center","city":"Green Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Kenosha South","city":"Kenosha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gundersen Lutheran Medical Center","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Ladysmith","city":"Ladysmith","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Bay Area Medical Group-Marinette","city":"Marinette","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Marshfield","city":"Marshfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Milwaukee","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Saint Luke's Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Sinai Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Minocqua","city":"Minocqua","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center of Western Wisconsin","city":"New Richmond","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic - Oshkosh","city":"Oshkosh","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Racine","city":"Racine","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Rice Lake","city":"Rice Lake","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic-Sheboygan","city":"Sheboygan","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-River Region at Stevens Point","city":"Stevens Point","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Medical Center in Summit","city":"Summit","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic-Two Rivers","city":"Two Rivers","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinic-Wausau Center","city":"Wausau","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Milwaukee West","city":"Wauwatosa","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora West Allis Medical Center","city":"West Allis","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinic - Wisconsin Rapids Center","city":"Wisconsin Rapids","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hospital of Laramie County","city":"Cheyenne","state":"Wyoming","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic-Cody","city":"Cody","state":"Wyoming","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Welch Cancer Center","city":"Sheridan","state":"Wyoming","country":"United States","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Best objective response"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["anchorage-alaska","fairbanks-alaska","fort-smith-arkansas","little-rock-arkansas","burbank-california","washington-d-c-district-of-columbia","fort-lauderdale-florida","atlanta-georgia","boise-idaho","caldwell-idaho","coeur-dalene-idaho","emmett-idaho","fruitland-idaho","meridian-idaho","nampa-idaho","post-falls-idaho","sandpoint-idaho","twin-falls-idaho","alton-illinois","aurora-illinois","bloomington-illinois","canton-illinois","carbondale-illinois","carterville-illinois","carthage-illinois","centralia-illinois","danville-illinois","decatur-illinois","dixon-illinois","effingham-illinois","eureka-illinois","evanston-illinois","galesburg-illinois","glenview-illinois","highland-park-illinois","kewanee-illinois","macomb-illinois","mattoon-illinois","mount-vernon-illinois","ofallon-illinois","ottawa-illinois","pekin-illinois","peoria-illinois","peru-illinois","princeton-illinois","skokie-illinois","springfield-illinois","swansea-illinois","urbana-illinois","washington-illinois","yorkville-illinois","zion-illinois","richmond-indiana","council-bluffs-iowa","des-moines-iowa","fort-dodge-iowa","west-des-moines-iowa","garden-city-kansas","great-bend-kansas","pittsburg-kansas","baton-rouge-louisiana","new-orleans-louisiana","baltimore-maryland","boston-massachusetts","springfield-massachusetts","alma-michigan","alpena-michigan","ann-arbor-michigan","battle-creek-michigan","brighton-michigan","canton-michigan","caro-michigan","chelsea-michigan","clarkston-michigan","detroit-michigan","east-china-township-michigan","flint-michigan","gladwin-michigan","grand-rapids-michigan","grosse-pointe-woods-michigan","kalamazoo-michigan","lansing-michigan","livonia-michigan","macomb-michigan","marlette-michigan","midland-michigan","mount-pleasant-michigan","muskegon-michigan","niles-michigan","norton-shores-michigan","novi-michigan","pontiac-michigan","reed-city-michigan","rochester-hills-michigan","saginaw-michigan","saint-joseph-michigan","southfield-michigan","sterling-heights-michigan","tawas-city-michigan","traverse-city-michigan","warren-michigan","west-branch-michigan","wyoming-michigan","ypsilanti-michigan","burnsville-minnesota","cambridge-minnesota","chaska-minnesota","coon-rapids-minnesota","edina-minnesota","fridley-minnesota","maple-grove-minnesota","maplewood-minnesota","minneapolis-minnesota","monticello-minnesota","new-ulm-minnesota","princeton-minnesota","robbinsdale-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","shakopee-minnesota","stillwater-minnesota","waconia-minnesota","willmar-minnesota","woodbury-minnesota","wyoming-minnesota","ballwin-missouri","bolivar-missouri","bonne-terre-missouri","branson-missouri","cape-girardeau-missouri","farmington-missouri","jefferson-city-missouri","joplin-missouri","osage-beach-missouri","rolla-missouri","saint-joseph-missouri","sainte-genevieve-missouri","springfield-missouri","st-louis-missouri","sullivan-missouri","washington-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","havre-montana","helena-montana","kalispell-montana","missoula-montana","omaha-nebraska","buffalo-new-york","middletown-new-york","white-plains-new-york","hendersonville-north-carolina","pinehurst-north-carolina","beavercreek-ohio","boardman-ohio","centerville-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","dayton-ohio","findlay-ohio","franklin-ohio","greenville-ohio","kettering-ohio","springfield-ohio","troy-ohio","warren-ohio","youngstown-ohio","oklahoma-city-oklahoma","baker-city-oregon","bend-oregon","clackamas-oregon","coos-bay-oregon","corvallis-oregon","newberg-oregon","ontario-oregon","oregon-city-oregon","portland-oregon","redmond-oregon","allentown-pennsylvania","bethlehem-pennsylvania","bryn-mawr-pennsylvania","collegeville-pennsylvania","east-stroudsburg-pennsylvania","exton-pennsylvania","hazleton-pennsylvania","media-pennsylvania","newtown-square-pennsylvania","paoli-pennsylvania","philadelphia-pennsylvania","reading-pennsylvania","wynnewood-pennsylvania","charlottesville-virginia","aberdeen-washington","bellingham-washington","centralia-washington","edmonds-washington","everett-washington","issaquah-washington","kennewick-washington","lacey-washington","longview-washington","seattle-washington","sedro-woolley-washington","shelton-washington","vancouver-washington","walla-walla-washington","yelm-washington","burlington-wisconsin","chippewa-falls-wisconsin","cudahy-wisconsin","eau-claire-wisconsin","fond-du-lac-wisconsin","germantown-wisconsin","grafton-wisconsin","green-bay-wisconsin","kenosha-wisconsin","la-crosse-wisconsin","ladysmith-wisconsin","marinette-wisconsin","marshfield-wisconsin","milwaukee-wisconsin","minocqua-wisconsin","new-richmond-wisconsin","oshkosh-wisconsin","racine-wisconsin","rice-lake-wisconsin","sheboygan-wisconsin","stevens-point-wisconsin","summit-wisconsin","two-rivers-wisconsin","wausau-wisconsin","wauwatosa-wisconsin","west-allis-wisconsin","weston-wisconsin","wisconsin-rapids-wisconsin","cheyenne-wyoming","cody-wyoming","sheridan-wyoming"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Advanced Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Participants must have a pathologically-confirmed diagnosis of non-small cell lung cancer (NSCLC)","An EGFR exon 20 insertion mutation must be detected in the tumor tissue. Patients may be enrolled in the study based on an exon 20 insertion EGFR mutation detected by any Clinical Laboratory Improvement Act (CLIA)-certified tissue assay","NOTE: Testing results are to be submitted via Medidata Rave and the study chair or delegate will review the reports","Patients must have measurable disease; baseline measurements and ALL sites of disease must be obtained within 4 weeks to registration","Patients must have previously received at least one line of therapy for their advanced lung cancer; there are no restrictions on the maximum number of prior therapies allowed","Participants must not have previously received osimertinib","Participants must have not previously received therapies targeting PDL1, PD1 or CTLA4 within 6 months (180 days) prior to registration"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography with Contrast, or Echocardiography Test. The registry lists allocation as na. This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 46 people at 347 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.675Z"},{"nctId":"NCT03221244","title":"Virtual Reality Attention Management","officialTitle":"Virtual Reality Attention Management Program for Improving Attention in Children","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of California, Davis","sponsorClass":"OTHER","summary":"Problems with distraction are widespread in the 21st century, but for people with developmental delays or behavioral challenges they can have more damaging effects. For example, susceptibility to distraction is associated with worse school and social performance, lower high school graduation rates, and increased incidence of serious accidents. The investigators' goal is to improve understanding of distractibility and develop a targeted treatment. The proposed intervention is based on models of habituation, which is a term that means reduced physiological and emotional response to a stimulus (e.g. moving object, or loud noise, etc.) as it is seen repeatedly. The investigators use virtual reality technology to show study participants distracting stimuli repeatedly in a virtual classroom setting, and their hypothesis states that participants will improve attention in the face of distraction by training with this technology intervention. The virtual classroom setting is especially relevant for children who have significant challenges with distractibility, such as children with ADHD. This intervention will likely be effective in helping individuals with other clinical disorders and perhaps the general population as well.","conditions":["ADHD"],"keywords":["Distractibility","Virtual Reality","Attention","Child","Pediatric"],"interventions":[{"type":"DEVICE","name":"VR Treatment"},{"type":"DEVICE","name":"VR Active Control"}],"enrollment":50,"startDate":"2016-06-02","completionDate":"2027-09-02","sex":"ALL","minAge":"8 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Significant (T score \\>= 60) ratings of Cognitive Problems/Inattention or DSM Inattention scale scores on the Conners' Parent or Teacher Rating Scale-3 or Parent ADHD Rating Scale-IV (ADHD-RS)\n* Endorsement of 4 or more symptoms of inattention on a clinical psychiatric interview (e.g. Parent DISC, DICA, Kiddie-SADS, Mini-KID)\n* Comfortable using a computer\n* Full Scale IQ \\> 80\n\nExclusion Criteria:\n\n* Psychosis (by parent report at phone screen), significant depression, autism (15 or \\> on Social Communication Questionnaire (SCQ)), psychotic disorders, visual or hearing impairment or any other disorder that may interfere with task performance\n* It is in the investigator's opinion that it is not in the subject's best interest to continue\n* Subject is non-compliant with training schedule\n* Subjects on pharmacotherapy for ADHD at the time of enrollment will be excluded from Aims 3 and 4.\n* Subjects starting behavioral or psychological treatment for ADHD during the training phase of the study will be excluded","locations":[{"facility":"UC Davis MIND Institute","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juan Ramos","phone":"916-703-0294","email":"hs-airlab@ucdavis.edu"},{"name":"Shannon Hoffman","phone":"916-703-0258","email":"hs-airlab@ucdavis.edu"}],"primaryOutcomes":["Decrease in the amount of eye movements toward the distractors and/or shorter duration of fixation on distractors.","Decrease in the amount of head movements toward the distractors"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["sacramento-california"],"enrichment":{"headline":"Not a traditional drug phase: VR Treatment for ADHD","inPlainEnglish":"Problems with distraction are widespread in the 21st century, but for people with developmental delays or behavioral challenges they can have more damaging effects. For example, susceptibility to distraction is associated with worse school and social performance, lower high school graduation rates, and increased incidence of serious accidents.","whoItsFor":["Ages 8 Years to 12 Years","Significant (T score \\>= 60) ratings of Cognitive Problems/Inattention or DSM Inattention scale scores on the Conners' Parent or Teacher Rating Scale-3 or Parent ADHD Rating Scale-IV (ADHD-RS)","Endorsement of 4 or more symptoms of inattention on a clinical psychiatric interview (e.g. Parent DISC, DICA, Kiddie-SADS, Mini-KID)","Comfortable using a computer","Full Scale IQ \\> 80"],"whoShouldSkip":["Psychosis (by parent report at phone screen), significant depression, autism (15 or \\> on Social Communication Questionnaire (SCQ)), psychotic disorders, visual or hearing impairment or any other disorder that may interfere with task performance","It is in the investigator's opinion that it is not in the subject's best interest to continue","Subject is non-compliant with training schedule","Subjects on pharmacotherapy for ADHD at the time of enrollment will be excluded from Aims 3 and 4","Subjects starting behavioral or psychological treatment for ADHD during the training phase of the study will be excluded"],"whatHappens":"If you join, the listed intervention(s) are VR Treatment, or VR Active Control. The registry lists allocation as randomized. Problems with distraction are widespread in the 21st century, but for people with developmental delays or behavioral challenges they can have more damaging effects.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Sacramento. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.653Z"},{"nctId":"NCT03223077","title":"Mucosal and Microbiota Changes During Acute Campylobacteriosis","officialTitle":"Mucosal and Microbiota Changes During Acute Campylobacteriosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS). The researchers are doing this study to understand if changes in gut bacteria and gut mucosal lining during an acute infection can help identify individuals who might be at risk for developing problems in the future.","conditions":["Irritable Bowel Syndrome"],"keywords":["Post infectious"],"interventions":[],"enrollment":150,"startDate":"2014-10-31","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* No abdominal surgery (except appendectomy and cholecystectomy)\n* Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter\n\nExclusion Criteria:\n\n* History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease.\n* History of gastroenteritis in six months prior to Campylobacter enteritis\n* Pregnancy","locations":[{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Margaret K Breen-Lyles, BS","phone":"507-255-3520","email":"Breen-Lyles.Margaret@mayo.edu"}],"primaryOutcomes":["Development of IBS is the endpoint."],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Mucosal and Microbiota Changes During Acute Campylobacteriosis","inPlainEnglish":"Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to develop chronic bowel problems such as Irritable Bowel Syndrome (IBS).","whoItsFor":["Ages 18 Years to 80 Years","No abdominal surgery (except appendectomy and cholecystectomy)","Stool culture or Polymerase chain reaction (PCR) positive enteritis with Campylobacter"],"whoShouldSkip":["History of IBS, Irritable Bowel Disease (IBD) (Crohn's disease or ulcerative colitis), microscopic colitis or celiac disease","History of gastroenteritis in six months prior to Campylobacter enteritis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Rochester. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.442Z"},{"nctId":"NCT03225144","title":"Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia","officialTitle":"Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nNeurodegenerative disorders can lead to problems in movement or memory. Some can cause abnormal proteins to build up in brain cells. Researchers want to understand whether these diseases have related causes or risk factors.\n\nObjective:\n\nTo test people with movement or thinking and memory problems to see if they are eligible for research studies.\n\nEligibility:\n\nPeople ages 18 and older with a neurodegenerative disorder associated with accumulation of TDP-43 or Tau proteins\n\nDesign:\n\nParticipants will have a screening visit. This may take place over 2-3 days. Tests include:\n\nMedical history\n\nPhysical exam\n\nQuestions about behavior and mood\n\nTests of memory, attention, concentration, and thinking\n\nMovement measurement. The speed at which participants can stand up from a chair, tap their finger and foot, and walk a short distance will be measured. Some movements will be videotaped. They will be videotaped while they speak and read a paragraph.\n\nBlood tests. This might include genetic testing.\n\nLung and breathing tests\n\nMRI. They will lie on a table that slides into a cylinder that takes pictures of the body. Some participants will get a dye through IV.\n\nElectromyography. A thin needle will be inserted into the muscles to measure electrical signals.\n\nNerve tests. Small electrodes on the skin record muscle and nerve activity.\n\nA small piece of skin may be removed.\n\nA skin or blood sample may be taken to create stem cells.\n\nOptional lumbar puncture. A needle will be inserted into the space between the bones of the back to collect fluid.\n\nIf participants are not eligible for current studies, they may be contacted in the future.\n\n...","conditions":["Frontotemporal Dementia","Amyotrophic Lateral Sclerosis","Progressive Supranuclear Palsy"],"keywords":["TDP-43","Progressive Supranuclear Palsy","Motor Neuron Disease","Frontotemporal Dementia","Corticobasal Syndrome","Natural History"],"interventions":[],"enrollment":360,"startDate":"2017-10-11","completionDate":"2027-10-30","sex":"ALL","minAge":"18 Years","maxAge":"110 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients will be included if they\n\n* Are age 18 or older\n* Have been given a diagnosis by a neurologist of frontotemporal dementia, primary progressive aphasia, semantic dementia, motor neuron disorder, amyotrophic lateral sclerosis, progressive bulbar palsy, corticobasal syndrome, Huntington disease or other related adult-onset neurodegenerative disorder OR\n* Carry a mutation in a gene that causes familial ALS or FTD\n\nEXCLUSION CRITERIA:\n\nPatients will be excluded if they\n\n* Have other major neurological or medical diseases that may cause progressive weakness or cognitive dysfunction, such as structural brain or spinal cord disease, metabolic diseases, paraneoplastic syndromes, infectious diseases, peripheral neuropathy or radiculopathy or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe\n* Require daytime ventilator support at the time of study entry\n* Are unable to travel to NIH\n* Patients with pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, or shrapnel fragments, metal fragments in the eye) will not be excluded but will not undergo magnetic resonance imaging.\n* Patients with tattoos above the neck or permanent make up will be excluded from undergoing 7T MRI.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol H Hoffman","phone":"(301) 451-1229","email":"carol.hoffman@nih.gov"},{"name":"Justin Y Kwan, M.D.","phone":"(301) 496-7428","email":"justin.kwan@nih.gov"}],"primaryOutcomes":["Clinical information"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotempor…","inPlainEnglish":"Background: Neurodegenerative disorders can lead to problems in movement or memory. Some can cause abnormal proteins to build up in brain cells.","whoItsFor":["Ages 18 Years to 110 Years","Patients will be included if they","Are age 18 or older","Carry a mutation in a gene that causes familial ALS or FTD"],"whoShouldSkip":["Patients will be excluded if they","Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe","Require daytime ventilator support at the time of study entry","Are unable to travel to NIH","Patients with tattoos above the neck or permanent make up will be excluded from undergoing 7T MRI"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 360 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.599Z"},{"nctId":"NCT03258567","title":"Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-HodgkinLymphomas","officialTitle":"Phase 2 Trial of Nivolumab in Epstein-Barr Virus (EBV)-Positive Lymphoproliferative Disorders and EBV-Positive Non-Hodgkin Lymphomas","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nThe drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers. They want to study its effects on cancers that may have not responded to chemotherapy or other treatments.\n\nObjectives:\n\nTo see if Nivolumab slows the growth of some types of cancer or stops them from getting worse. To test the safety of the drug.\n\nEligibility:\n\nPeople 12 and older who have Epstein-Barr Virus (EBV)-positive lymphoproliferative disorders or EBV-positive non-Hodgkin lymphomas with no standard therapy\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nCAT scan of the chest, abdomen, and pelvis\n\nTumor and bone marrow biopsies (sample taken)\n\nMagnetic resonance imaging scan of the brain\n\nLumbar puncture (also known as spinal tap)\n\nPositron emission tomography/computed tomography scan with a radioactive tracer\n\nEvery 2 weeks, participants will get Nivolumab by vein over about 1 hour. They will also have:\n\nPhysical exam\n\nBlood and pregnancy tests\n\nReview of side effects and medications\n\nDuring the study, participants will repeat most of the screening tests. They may also have other biopsies.\n\nAfter stopping treatment, participants will have a visit every 3 months for 1 year. Then they will have a visit every 6 months for years 2-5, and then once a year. They will have a physical exam and blood tests.","conditions":["Epstein-Barr Virus Infections","Lymphoma","Lymphoproliferative Disorder","Disorders, Lymphoproliferative"],"keywords":["Monoclonal Antibody"],"interventions":[{"type":"BIOLOGICAL","name":"Nivolumab"}],"enrollment":40,"startDate":"2018-04-26","completionDate":"2029-06-01","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI.\n\n  * EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy.\n\n    1. Lymphomatoid granulomatosis (LYG), grades I-II\n    2. Chronic active EBV disease (CAEBV) of B-cells or T-cells\n    3. EBV-positive post-transplantation lymphoproliferative disorder (PTLD)\n\n       NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible.\n  * EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same.\n\n    1. Lymphomatoid granulomatosis (LYG), grade III\n    2. EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\n    3. EBV-positive DLBCL\n* Subjects must be at least 2 weeks from prior anti-lymphoma therapy (including radiation therapy)\n* Subjects must be at least 100 days from prior stem cell transplant (autologous or allogeneic) or Donor Lymphocyte Infusion (DLI)\n\n  * Age \\>=12 years\n  * Patients \\>= 12 and \\< 18 years of age should weigh at least 40 kilograms (kg); there is no weight requirement for adult subjects.\n  * NOTE: If a pediatric patient is identified for possible enrollment who weighs less than 40 kg, the safety of the nivolumab dosing strategy used in this study must be discussed with the PI and manufacturer to confirm safety, and this discussion/approval for enrollment documented in the medical record prior to declaring the pediatric patient eligible.\n* Adequate performance status as follows:\n\n  * Patients \\>= 16 years must have ECOG Performance Status 0-2 (Karnofsky \\>=60%)\n  * Pediatric patients \\< 16 years must have Lansky play-performance of 60-100%\n* Subjects must have measurable or evaluable disease.\n* Subjects must have adequate organ and bone marrow reserve (unless disease-related) as defined below:\n\n  * absolute neutrophil count - \\>= 750/mcL; \\>= 500/mcL if impairment is due to LPD/NHL\n  * platelets - \\>= 50,000/mcL; \\>= 25,000/mcL if impairment is due to LPD/NHL (transfusions not permitted)\n  * Hemoglobin - \\>= 9g/dL (transfusion permitted)\n  * total bilirubin - \\< 3.0g/dl OR \\< 5.0g/dl if Gilbert s syndrome or disease infiltration of the liver is present\n  * AST(SGOT)/ALT(SGPT) - \\<= 3 X institutional upper limit of normal\n  * serum creatinine OR creatinine clearance - Adults: \\<= 1.5 mg/dL; Minors: serum Cr \\<= age-adjusted normal OR \\>= 40 ml/min/1.73m\\^2\n\nAge(Years) 12-15: Maximum Serum Creatinine (mg/dl): 1.2\n\nAge(Years) \\> 15: Maximum Serum Creatinine (mg/dl): 1.5\n\n* A formalin fixed tissue block or at least 15 slides of tumor sample (archival or fresh) must be available for performance of correlative studies. NOTE: Patient must be willing to have a pre-treatment tumor biopsy if adequate archival tissue is not available.\n* The toxicity profile of nivolumab in patients with disease involvement of the central nervous system (CNS) is unknown. For this reason, we will introduce early stopping rules.\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, the following measures apply:\n\n  * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) during screening and within 48 hours prior to the first dose of nivolumab.\n  * WOCBP and men who are sexually active with WOCBP must use adequate contraception (e.g., hormonal or 2 barrier methods with a failure rate of less than 1% per year or abstinence) prior to study entry and throughout study drug administration. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 23 weeks after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product.\n  * Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception).\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), and who is not postmenopausal. Post menopause is defined as:\n\n    1. Amenorrhea \\>= 12 consecutive months without another cause, and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU/mL or\n    2. Women with irregular menstrual periods and a documented serum follicle stimulating hormone (FSH) level \\> 35 mIU/mL or NOTE: FSH level testing is not required for women \\>= 62 years old with amenorrhea of \\>= 1 year\n    3. Women on hormone replacement therapy (HRT)\n* Pregnant women are excluded from this study because nivolumab is an IgG monoclonal antibody with the potential for teratogenic or abortifacient effects.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with nivolumab, nursing should be discontinued if the mother is treated with nivolumab.\n* Ability of subject or Legally Authorized Representative (LAR) to understand and sign the written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Subjects who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.\n* Subjects with second malignancies requiring active systemic therapy are excluded. Subjects with second malignancies not requiring active systemic therapy or pre-malignant conditions such as monoclonal B-cell lymphocytosis (MBL) or monoclonal gammopathy of undetermined significance (MGUS) may be eligible.\n* Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted.\n* Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \\>=grade II acute GVHD or extensive chronic GVHD.\n* Subjects who have had solid organ transplant.\n* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody.\n* Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration.\n* A serious uncontrolled medical condition requiring therapy.\n* Seizures disorder not controlled by anti-seizure medications.\n* Subjects with CNS involvement may be included on the study as long as they have not had any seizure activity in past 4 weeks.\n* Hepatitis B virus surface antigen positive.\n* Active Hepatitis C infection with a positive PCR; subjects who are Hepatitis C antibody positive and PCR negative may be eligible. In these cases, the subjects will be monitored via HCV PCR throughout the study.\n* History of anaphylactic reaction to monoclonal antibody therapy.\n* HIV positive subjects are excluded because the function of their T-cell immune responses is impaired.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Medical Oncology Referral Office","phone":"(240) 760-6050","email":"ncimo_referrals@nih.gov"},{"name":"Christopher J Melani, M.D.","phone":"(240) 760-6057","email":"christopher.melani@nih.gov"}],"primaryOutcomes":["overall response rate of nivolumab in patients with EBV-positive LPD and EBV-positive NHL"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":["nivolumab"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Nivolumab for Epstein-Barr Virus Infections","inPlainEnglish":"Background: The drug Nivolumab has been approved to treat some cancers. Researchers want to see if it can slow the growth of other cancers.","whoItsFor":["Ages 12 Years to any","Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, NCI","EBV-positive LPD. Subjects may be previously untreated or relapsed from prior therapy","Lymphomatoid granulomatosis (LYG), grades I-II","Chronic active EBV disease (CAEBV) of B-cells or T-cells","EBV-positive post-transplantation lymphoproliferative disorder (PTLD)","NOTE: PTLD after solid organ transplantation is excluded. Patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible","EBV-positive B-cell NHL. Subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same"],"whoShouldSkip":["Subjects who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab","Subjects with any condition or autoimmune disease that requires systemic corticosteroids (\\> 10 mg daily prednisone equivalents) or immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted","Subjects with active graft-vs-host disease (GVHD) requiring steroids or other immunosuppressive agents; history of \\>=grade II acute GVHD or extensive chronic GVHD","Subjects who have had solid organ transplant","Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody","Non-oncology vaccine therapies for prevention of infectious disease within 4 weeks of study drug administration"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab. The registry lists allocation as randomized. Background: The drug Nivolumab has been approved to treat some cancers.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.153Z"},{"nctId":"NCT03263572","title":"Blinatumomab, Methotrexate, Cytarabine, and Ponatinib in Treating Patients With Philadelphia Chromosome-Positive, or BCR-ABL Positive, or Relapsed/Refractory, Acute Lymphoblastic Leukemia","officialTitle":"Phase II Study of the Combination of Blinatumomab and Ponatinib in Patients With Philadelphia Chromosome (Ph)-Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as methotrexate and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving blinatumomab, methotrexate, cytarabine, and ponatinib may work better in treating patients with acute lymphoblastic leukemia.","conditions":["Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Acute Lymphoblastic Leukemia","BCR-ABL1 Fusion Protein Expression","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Philadelphia Chromosome Positive","Recurrent Acute Lymphoblastic Leukemia","Refractory Acute Lymphoblastic Leukemia","t(9;22)"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Blinatumomab"},{"type":"DRUG","name":"Cytarabine"},{"type":"DRUG","name":"Methotrexate"},{"type":"DRUG","name":"Ponatinib"}],"enrollment":90,"startDate":"2017-11-29","completionDate":"2027-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of one of the following:\n\n   1. Participants ≥ 18 years of age with previously untreated Ph-positive ALL \\[either t(9;22) and/or BCR-ABL positive\\] (includes patients initiated on first course of therapy before cytogenetics known) or with lymphoid accelerated or blast phase CML. These participants could have received one or two courses of chemotherapy with or without other TKIs and still eligible. (Participants with lymphoid accelerated or blast phase CML will be evaluated separately) i. If they achieved CR, they are assessable only for event-free and overall survival, or ii. If they failed to achieve CR, they are assessable for CR, event-free, and overall survival\n   2. Participants ≥ 18 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n   3. Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)\n2. Performance status ≤ 2 (ECOG Scale)\n3. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n   1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n   2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR\n   3. Aspartate aminotransferase (AST) ≤ 3 x ULN\n4. Adequate pancreatic function as defined by the following criteria:\n\n   a) Serum lipase and amylase ≤ 1.5 x ULN\n5. For females of childbearing potential, a negative urine pregnancy test must be documented\n6. Female participants who:\n\n   * Are postmenopausal for at least 1 year before the screening visit, OR\n   * Are surgically sterile, OR\n   * If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse\n7. Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n\n   * Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or\n   * Agree to completely abstain from heterosexual intercourse\n8. Adequate cardiac function as assessed clinically by history and physical examination.\n9. Signed informed consent\n\nExclusion Criteria:\n\n1. Active serious infection not controlled by oral or intravenous antibiotics.\n2. History of acute pancreatitis within 1 year of study or history of chronic pancreatitis\n3. History of alcohol abuse\n4. Uncontrolled hypertriglyceridemia (triglycerides \\> 650mg/L)\n5. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n6. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n7. Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:\n\n   * Myocardial infarction (MI), stroke, or revascularization within 3 months\n   * Unstable angina or transient ischemic attack\n   * Congestive heart failure prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards prior to enrollment\n   * Diagnosed or suspected congenital long QT syndrome\n   * Clinically significant atrial or ventricular arrhythmias (such as artrial fibrillation, ventricular tachycardia, ventricular fibrillation, or Torsades de pointes) as determined by the treating physician\n   * Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n   * Significant venous or arterial thromboembolism including deep venous thrombosis or pulmonary embolism. Participants with a history of treated prior superficial or catheter associated will not be considered as significant embolism and after discussion with PI will not be excluded from eligibility.\n   * Uncontrolled hypertension (diastolic blood pressure \\>90mmHg; systolic \\>140mmHg). Participants with hypertension should be under treatment on study entry to effect blood pressure control\n8. History or presence of clinically relevant CNS pathology or event such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or severe (grade 3 or above) CNS events including ICANS from prior CART or other T cell engager therapies. Participants with active CNS leukemia - will NOT be excluded\n9. Current autoimmune disease or history of autoimmune disease with potential CNS involvement\n10. Treatment with any investigational antileukemic agents or chemotherapy agents within 2 weeks prior to study entry, unless full recovery from side effects has occurred or participant has rapidly progressive disease judged to be life-threatening by the investigator.\n11. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.\n12. History of significant bleeding disorder unrelated to cancer, including:\n\n    * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)\n    * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)\n13. Participants with documented significant pleural or pericardial effusions unless they are thought to be secondary to their leukemia.\n14. Known active infection with HIV, HBV, HCV.","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elias Jabbour, MD","phone":"713-792-4764","email":"ejabbour@mdanderson.org"}],"primaryOutcomes":["Complete molecular response (CMR) rate in newly diagnosed Ph-positive and/or BCR-ABL-positive acute lymphoblastic leukemia (ALL)","Overall response rate (ORR) in relapsed/refractory ALL","Relapse-free survival","Event-free survival","Overall survival"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Blinatumomab for Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","inPlainEnglish":"This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","Diagnosis of one of the following:","Participants ≥ 18 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)","Participants ≥ 18 years of age with ALL MRD positive (either by NGS or PCR or flowcytometry) or with previously treated lymphoid accelerated or blast phase CML (Participants with lymphoid accelerated or blast phase CML will be evaluated separately)","Performance status ≤ 2 (ECOG Scale)","Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):","Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome","Alanine aminotransferase (ALT) ≤ 3 x ULN, OR"],"whoShouldSkip":["Active serious infection not controlled by oral or intravenous antibiotics","History of acute pancreatitis within 1 year of study or history of chronic pancreatitis","History of alcohol abuse","Uncontrolled hypertriglyceridemia (triglycerides \\> 650mg/L)","Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year","Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria","Uncontrolled, or active cardiovascular disease, specifically including, but not restricted to:"],"whatHappens":"If you join, the listed intervention(s) are Blinatumomab, Cytarabine, or Methotrexate. The registry lists allocation as na. This phase II trial studies how well blinatumomab, methotrexate, cytarabine, and ponatinib work in treating patients with Philadelphia chromosome (Ph)-positive, or BCR-ABL positive, or acute lymphoblastic leukemia that has come back or does not respond to treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.811Z"},{"nctId":"NCT03268135","title":"Heart Failure and Aortic Stenosis Transcriptome","officialTitle":"Study of the Transcriptomic Alterations in Heart Failure and Aortic Stenosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS Policlinico S. Donato","sponsorClass":"OTHER","summary":"This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.","conditions":["Heart Failure","Aortic Stenosis"],"keywords":["miRNA","lncRNAs","transcriptome","heart failure","aortic stenosis","biomarkers"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"measurement of RNAs"}],"enrollment":500,"startDate":"2016-05-30","completionDate":"2024-12-31","sex":"ALL","minAge":"40 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Non end-stage heart failure\n\n   * left ventricle restoration surgery (SVR)\n   * End Systolic Volume Index (ESVI) \\>35 ml/m2\n   * Ejection Fraction (EF)\\<40%\n   * previous transmural anterior myocardial infarction (MI)\n   * age: 40-75\n2. End-stage heart failure\n\n   * left ventricle assisted device (LVAD) surgery\n   * age: 40-75\n   * Ejection Fraction (EF) \\<25%\n   * End Systolic Volume Index (ESVI)≥60 ml/m2\n3. Aortic Stenosis\n\n   * aortic valve replacement\n   * intracardial pressure difference \\>40 mmHg\n   * septal diameter ≥1.3 cm\n\nExclusion Criteria:\n\n1. Non end-stage heart failure\n\n   * End Systolic Volume Index (ESVI)\\<35 ml/m2\n   * Ejection Fraction (EF)\\>40%\n   * Time from MI unknown\n   * Pregnancy\n   * Other genetic diseases\n   * Neoplasms\n   * Collagenopathies\n   * Chemo/radiotherapy\n   * Prolonged use of corticosteroids\n   * Infections\n   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive\n2. End-stage heart failure\n\n   * EF\\>25%\n   * Time from MI unknown\n   * Pregnancy\n   * Other genetic diseases\n   * Neoplasms\n   * Collagenopathies\n   * Chemo/radiotherapy\n   * Prolonged use of corticosteroids\n   * Infections\n   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive\n3. Aortic Stenosis\n\n   * coronaropathies\n   * Pregnancy\n   * Other genetic diseases\n   * Neoplasms\n   * Collagenopathies\n   * Chemo/radiotherapy\n   * Prolonged use of corticosteroids\n   * Infections\n   * Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive","locations":[{"facility":"Irccs Policlinico San Donato","city":"San Donato Milanese","state":"Milan","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fabio Martelli, Dr","phone":"+39 02 26437762","email":"fabio.martelli@grupposandonato.it"}],"primaryOutcomes":["Cardiac tissutal mRNAs signatures","Cardiac tissutal miRNAs signatures","Cardiac tissutal lncRNAs signatures"],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["san-donato-milanese-italy","milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: measurement of RNAs for Heart Failure","inPlainEnglish":"This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers.","whoItsFor":["Ages 40 Years to 75 Years","Non end-stage heart failure","left ventricle restoration surgery (SVR)","End Systolic Volume Index (ESVI) \\>35 ml/m2","Ejection Fraction (EF)\\<40%","previous transmural anterior myocardial infarction (MI)","End-stage heart failure","left ventricle assisted device (LVAD) surgery"],"whoShouldSkip":["Non end-stage heart failure","End Systolic Volume Index (ESVI)\\<35 ml/m2","Ejection Fraction (EF)\\>40%","Time from MI unknown","Other genetic diseases","Prolonged use of corticosteroids","Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) (not vaccination) and Hepatitis C Virus (HCV) positive"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.445Z"},{"nctId":"NCT03312556","title":"Treatment of Supine Hypertension in Autonomic Failure (CPAP)","officialTitle":"Treatment of Supine Hypertension in Autonomic Failure With Continuous Positive Airway Pressure","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Vanderbilt University Medical Center","sponsorClass":"OTHER","summary":"Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension. The purpose of this study is to assess whether continuous positive airway pressure (CPAP) decreases blood pressure in autonomic failure patients with supine hypertension.","conditions":["Supine Hypertension","Autonomic Failure"],"keywords":["hypertension","supine hypertension","autonomic failure","pure autonomic failure","multiple system atrophy","cpap"],"interventions":[{"type":"DEVICE","name":"continuous positive airway pressure (CPAP)"},{"type":"DRUG","name":"Placebo"}],"enrollment":12,"startDate":"2017-09-21","completionDate":"2026-12-21","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with autonomic failure and with supine hypertension from all races\n\nExclusion Criteria:\n\n* All medical students\n* Pregnant women\n* High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)\n* History of serious allergies or asthma.","locations":[{"facility":"Autonomic Dysfunction Center/ Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bonnie K Black, RN","phone":"615-343-6862","email":"autonomics@vumc.org"},{"name":"Luis E Okamoto, MD","phone":"(615) 936-6119","email":"autonomics@vumc.org"}],"primaryOutcomes":["Supine Systolic Blood Pressure"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: testing Placebo for Supine Hypertension","inPlainEnglish":"Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe and complicates the treatment of orthostatic hypotension.","whoItsFor":["Ages 18 Years to 85 Years","Patients with autonomic failure and with supine hypertension from all races"],"whoShouldSkip":["All medical students","High-risk patients (e.g. heart failure, symptomatic coronary artery disease, liver impairment, history of stroke or myocardial infarction)","History of serious allergies or asthma"],"whatHappens":"If you join, the listed intervention(s) are continuous positive airway pressure (CPAP), or Placebo. The registry lists allocation as randomized. Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 12 people at Nashville. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.037Z"},{"nctId":"NCT03340506","title":"Dabrafenib and/or Trametinib Rollover Study","officialTitle":"Open Label, Multi-center Roll-over Study to Assess Long Term Safety in Patients Who Have Completed a Global Novartis or GSK Sponsored Dabrafenib and/or Trametinib Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.","conditions":["Melanoma","Non Small Cell Lung Cancer","Solid Tumor","Rare Cancers","High Grade Glioma"],"keywords":["Tafinlar","Mekinist","Dabrafenib","Trametinib","Adult","Melanoma","Melanoma Stage IV","Metastatic Melanoma","Advanced Melanoma","Lung Cancer","NSLC","Non Small Cell Lung Cancer","BRAF V600 Mutation","BRAF Gene Mutation","Solid tumor","Rare cancers","High Grade Glioma"],"interventions":[{"type":"DRUG","name":"dabrafenib"},{"type":"DRUG","name":"trametinib"}],"enrollment":100,"startDate":"2018-01-26","completionDate":"2032-12-28","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective.\n* In the opinion of the Investigator would benefit from continued treatment.\n\nExclusion Criteria:\n\n* Patient has been previously permanently discontinued from study treatment in the parent protocol.\n* Patient's indication is commercially available and reimbursed in the local country.\n* Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study.","locations":[{"facility":"Honor Health Research Institute","city":"Scottsdale","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Institute Of Health","city":"Bethesda","state":"Maryland","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"James Cancer Hospital and Solove Research Institute Ohio State","city":"Columbus","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mary Crowley Cancer Research","city":"Dallas","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Caba","state":"Buenos Aires","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Innsbruck","state":"Tyrol","country":"Austria","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Brno","state":"","country":"Czechia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Prague","state":"","country":"Czechia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Copenhagen","state":"","country":"Denmark","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Lyon","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nantes","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Paris","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Mannheim","state":"Baden-Wurttemberg","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Augsburg","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Berlin","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Essen","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hamburg","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Heidelberg","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Debrecen","state":"Hajdu Bihar Megye","country":"Hungary","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Budapest","state":"","country":"Hungary","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kashiwa","state":"Chiba","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Chuo Ku","state":"Tokyo","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Utrecht","state":"","country":"Netherlands","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Moscow","state":"","country":"Russia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Madrid","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Valencia","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Songkhla","state":"Hat Yai","country":"Thailand","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"}],"primaryOutcomes":["Occurences of adverse events to evaluate long term safety and tolerability of dabrafenib, trametinib or combination"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","bethesda-maryland","columbus-ohio","dallas-texas","caba-argentina","innsbruck-austria","toronto-canada","beijing-china","brno-czechia","prague-czechia","copenhagen-denmark","lyon-france","nantes-france","paris-france","villejuif-france","mannheim-germany","augsburg-germany","berlin-germany","essen-germany","hamburg-germany","heidelberg-germany","debrecen-hungary","budapest-hungary","kashiwa-japan","chuo-ku-japan","rotterdam-netherlands","utrecht-netherlands","moscow-russia","barcelona-spain","madrid-spain","valencia-spain","songkhla-thailand"],"enrichment":{"headline":"Phase 4: testing dabrafenib for Melanoma","inPlainEnglish":"This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.","whoItsFor":["Ages 18 Years to 100 Years","Patient is currently receiving treatment with dabrafenib/trametinib this drug alone or combination within a Novartis or former GSK sponsored study which has fulfilled the requirements for the primary objective","In the opinion of the Investigator would benefit from continued treatment"],"whoShouldSkip":["Patient has been previously permanently discontinued from study treatment in the parent protocol","Patient's indication is commercially available and reimbursed in the local country","Patient currently has unresolved toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study"],"whatHappens":"If you join, the listed intervention(s) are dabrafenib, or trametinib. The registry lists allocation as randomized. This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.707Z"},{"nctId":"NCT03374267","title":"Registry Platform Urologic Cancer","officialTitle":"Clinical Research Platform On Urologic Cancer Treatment And Outcome (Registry Platform Urologic Cancer; CARAT)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"iOMEDICO AG","sponsorClass":"INDUSTRY","summary":"The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or urothelial cancer in Germany.","conditions":["Renal Cell Carcinoma","Urothelial Carcinoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Routine care as per site standard."}],"enrollment":2230,"startDate":"2017-12-07","completionDate":"2034-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)\n* Patients at start of their first-line systemic treatment for aRCC or aUBC\n* Written informed consent\n\n  * Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment\n  * Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC\n* Age ≥ 18 years\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower or upper urinary tract (ICD-10 C65, C66, C67.x, C68.x). Mixed histologies are allowed (main compo-nent must be urothelial carcinoma, with minor variants accept-ed).\n* Radical surgery (e.g., radical cystectomy, nephroureterecto-my) between October 1, 2021 and October 31, 2024.\n* High-risk of recurrence, defined as follows: Post-operative, pathological tumor status\n\n  * ypT2-ypT4 and/or ypN+ and without clinically detectable metastases (M0) at cystectomy for patients with prior neo-adjuvant chemotherapy or\n  * pT3-pT4 and/or pN+ and without clinically detectable me-tastases (M0) at cystectomy for patients without prior neo-adjuvant chemotherapy.\n* Age ≥ 18 years at the time of surgery.\n* Written informed consent (only if patient is alive at time of data entry; not applicable for inclusion of deceased patients' data)\n\nCohort MIBC (prospective)\n\n* Diagnosis of MIBC (muscle-invasive bladder cancer; ICD-10 C67.x; cT2-T4aN0M0 or T1-T4aN1M0).\n* Histologically proven muscle-invasive urothelial carcinoma. Mixed histologies are allowed (main component must be urothelial histology, with minor variants accepted).\n* Age ≥ 18 years at the time of diagnosis.\n* Written informed consent within 15 weeks from diagnosis of MIBC.\n\nExclusion Criteria:\n\nCohorts aRCC and aUBC (prospective)\n\n* Patients with prior systemic therapy for aRCC or aUBC\n* No systemic treatment for aRCC or aUBC\n\nCohort High-risk MIUC (prospective and retrospective)\n\n* Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy\n* Metastatic disease (M1) at the time of surgery\n\nCohort MIBC (prospective)\n\n* Clinically detectable metastases (M1) at the time of diagnosis.\n* Treatment in palliative intention (for tumors considered inoperable).","locations":[{"facility":"Multiple sites, Germany","city":"Multiple Locations","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michaela Koska","phone":"+49 761 15242-0","email":"info@iomedico.de"}],"primaryOutcomes":["Course of treatment (treatment reality)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["multiple-locations-germany"],"enrichment":{"headline":"Not a traditional drug phase: Routine care as per site standard. for Renal Cell Carcinoma","inPlainEnglish":"The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced renal cell carcinoma or urothelial cancer in Germany.","whoItsFor":["Ages 18 Years to any","Cohorts aRCC and aUBC (prospective)","Female and male patients with aRCC or aUBC (locally advanced, inoperable or metastatic)","Patients at start of their first-line systemic treatment for aRCC or aUBC","Patients participating in the PRO module: signing of in-formed consent form and completion of baseline questionnaire before start of initial systemic treatment","Patients not participating in the PRO module: within twelve weeks after start of systemic first-line for aRCC or aUBC","Cohort High-risk MIUC (prospective and retrospective)","Histologically proven muscle-invasive urothelial carcinoma (MIUC) of the lower or upper urinary tract (ICD-10 C65, C66, C67.x, C68.x). Mixed histologies are allowed (main compo-nent must be urothelial carcinoma, with minor variants accept-ed)"],"whoShouldSkip":["Cohorts aRCC and aUBC (prospective)","Patients with prior systemic therapy for aRCC or aUBC","No systemic treatment for aRCC or aUBC","Cohort High-risk MIUC (prospective and retrospective)","Partial cystectomy or partial nephrectomy of the primary tumor as definitive therapy","Metastatic disease (M1) at the time of surgery","Cohort MIBC (prospective)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,230 people at Multiple Locations. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.908Z"},{"nctId":"NCT03407469","title":"Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization","officialTitle":"Measurement of Adherence and Health-related Quality of Life, and Health-Care Resource Utilization During Anticoagulation Therapy in Cancer-Related Venous Thromboembolism (VTE)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer.\n\nThis is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.","conditions":["Cancer-related Venous Thromboembolism"],"keywords":["Questionnaires","Surveys","Cancer-related Venous Thromboembolism","VTE"],"interventions":[{"type":"BEHAVIORAL","name":"Questionnaires"}],"enrollment":260,"startDate":"2018-01-12","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult (≥ 18 years) female or male subjects.\n2. Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography.\n3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis.\n4. Intention for long-term treatment (at least 3 months) with anticoagulation.\n5. Participants will be enrolled in the study within the first 5 days from initiation of anticoagulation.\n6. Able to provide informed consent and complete study survey tools\n7. Able to read and speak English.\n\nExclusion Criteria:\n\n1. Indication for anticoagulation other than cancer-related VTE.\n2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.\n3. Life expectancy \\< 3 months.\n4. Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT.","locations":[{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Valle del Lili","city":"Cali","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic","city":"Barcelona","state":"Carrer de Villarroel, 170","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital German Trias i Pujol","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cristhiam M. Rojas Hernandez, MD","phone":"713-563-3070","email":"cmrojas@mdanderson.org"}],"primaryOutcomes":["Self-Reported Adherence to Anticoagulation"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas","cali-colombia","barcelona-spain"],"enrichment":{"headline":"Not a traditional drug phase: Questionnaires for Cancer-related Venous Thromboembolism","inPlainEnglish":"The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer. Up to 260 you would be enrolled in this multicenter study.","whoItsFor":["Ages 18 Years to any","Adult (≥ 18 years) female or male subjects","Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis","Intention for long-term treatment (at least 3 months) with anticoagulation","you would be enrolled in the study within the first 5 days from initiation of anticoagulation"],"whoShouldSkip":["Indication for anticoagulation other than cancer-related VTE","An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment","Life expectancy \\< 3 months","Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 260 people at 4 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.108Z"},{"nctId":"NCT03414502","title":"Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response","officialTitle":"Treatment of Rheumatoid Arthritis With Disease-modifying Antirheumatic Drugs (DMARDs): Predictors of Response","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Nebraska","sponsorClass":"OTHER","summary":"Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure. Current treatment goals are to minimize pain, limit joint damage, and prevent loss of function. Drugs used to treat RA include non-steroidal anti-inflammatory drugs (NSAIDS), glucocorticoids, and disease-modifying anti-rheumatic drugs (DMARDs), including biologics. Methotrexate (MTX) is the DMARD of choice in the treatment of RA, because it has been shown to be both well-tolerated and effective in achieving clinical response and slowing radiographic progression of disease. However, this drug alone results in remissions in only a small subset of patients and reliable predictors of DMARD response have yet to be identified.\n\nThis study is open-label of 16-weeks duration to identify factors that help predict clinical responses to disease-modifying antirheumatic drugs (DMARD) therapies for rheumatoid arthritis (RA) participants. All participants will receive a starting dose of DMARD medication(s) which may be adjusted by the investigator as needed. If a participant becomes intolerant of a DMARD medication, the participant will be withdrawn at the discretion of the investigator. Necessary withdrawals prior to week 16 visits will be considered end of study. Otherwise, end of study data as well as study serum will be collected at week 16. A portion of the blood collected at baseline, week 8 and week 16 for the optional addendum portion of the study is for future research and will be utilized attempting to look to detect the generation of superoxide radicals. These radicals have been shown to be associated with inflammation and may correlate with the progression of RA, which if confirmed, should decrease the levels of these radicals signaling response to treatment.","conditions":["Rheumatoid Arthritis"],"keywords":["Methotrexate","DMARD"],"interventions":[{"type":"DRUG","name":"Methotrexate"},{"type":"DRUG","name":"Abatacept"},{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Azathioprine"},{"type":"DRUG","name":"Baricitinib"},{"type":"DRUG","name":"Certolizumab"},{"type":"DRUG","name":"Etanercept"},{"type":"DRUG","name":"Golimumab"},{"type":"DRUG","name":"Hydroxychloroquine"},{"type":"DRUG","name":"Infliximab"},{"type":"DRUG","name":"Leflunomide"},{"type":"DRUG","name":"Minocycline"},{"type":"DRUG","name":"Rituximab"},{"type":"DRUG","name":"Sarilumab"},{"type":"DRUG","name":"Sulfasalazine"},{"type":"DRUG","name":"Tofacitinib"}],"enrollment":400,"startDate":"2007-12-10","completionDate":"2028-03","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\n* Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria\n\n  * Morning stiffness for at least 1 hour for at least 6 weeks\n  * Swelling of 3 or more joints for at least 6 weeks\n  * Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks\n  * Symmetric joint swelling\n  * Hand x-rays with erosions or bony decalcifications\n  * RA nodules\n  * Rheumatoid factor (RF) positive\n* \\>19 yrs old at RA diagnosis\n* Active disease with at least 1 swollen joint\n* Starting new DMARD medication(s) (abatacept, adalimumab, azathioprine, barcitinib, certolizumab, etanercept, golimumab, hydroxychloroquine, infliximab, leflunomide, methotrexate, minocycline, rituximab, sarilumab, sulfasalazine, tofacitinib)\n* If on other DMARDS, must be on stable dose for ≥ 6 wks\n* If on glucocorticoids, must be on stable dose for 2 wks (\\< 10mg of Prednisone/day or equivalent)\n* Able to adhere to study visit schedule: enrollment (8 wks \\& 16 wks +/- 2 wks)\n* Hemoglobin (Hgb) \\> 9g/dl\n* Platelets \\>100\n* Creatinine \\<1.6\n* Aspartate transferase (AST) or alanine aminotransferase (ALT) at or below 1.2 x upper limit\n* Albumin up to 1.0 g/dL below lower limit of normal\n\nEXCLUSION CRITERIA:\n\n* Pregnant or breastfeeding women\n* Men and women of child bearing potential unwilling to practice effective method of contraception","locations":[{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aimee B Schreiner, MS","phone":"402-559-4873","email":"aischreiner@unmc.edu"}],"primaryOutcomes":["Efficacy of Disease-modifying Antirheumatic Drugs Therapy for Rheumatoid Arthritis"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis"],"drugSlugs":["adalimumab"],"locationSlugs":["omaha-nebraska"],"enrichment":{"headline":"Phase 3: testing Methotrexate for Rheumatoid Arthritis","inPlainEnglish":"Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence. RA is also a chronic, progressive disease with no cure.","whoItsFor":["Ages 19 Years to any","Diagnosed rheumatoid arthritis (RA) with 4 of 7 American College of Rheumatology criteria","Morning stiffness for at least 1 hour for at least 6 weeks","Swelling of 3 or more joints for at least 6 weeks","Swelling of wrist, metacarpophalangeal (MCP), or proximal interphalangeal joints for 6 or more weeks","Symmetric joint swelling","Hand x-rays with erosions or bony decalcifications","Rheumatoid factor (RF) positive"],"whoShouldSkip":["Pregnant or breastfeeding women","Men and women of child bearing potential unwilling to practice effective method of contraception"],"whatHappens":"If you join, the listed intervention(s) are Methotrexate, Abatacept, or Adalimumab. The registry lists allocation as randomized. Rheumatoid arthritis (RA) is a common disease with approximately 1% prevalence.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at Omaha. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.270Z"},{"nctId":"NCT03424005","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","officialTitle":"A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.\n\nThe study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study:\n\nCohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \\[1L\\] PD-L1+ cohort).\n\nCohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \\[2L\\] CIT-naïve cohort).\n\nCohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations.\n\nCohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort).\n\nIn each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.","conditions":["Metastatic Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Atezolizumab"},{"type":"DRUG","name":"Ipatasertib"},{"type":"DRUG","name":"SGN-LIV1A"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Chemotherapy (Gemcitabine + Carboplatin or Eribulin)"},{"type":"DRUG","name":"Selicrelumab"},{"type":"DRUG","name":"Tocilizumab"},{"type":"DRUG","name":"Nab-Paclitaxel"},{"type":"DRUG","name":"Sacituzumab Govitecan"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Ribociclib (Dose #1)"},{"type":"DRUG","name":"Inavolisib (Dose #1)"},{"type":"DRUG","name":"Trastuzumab Deruxtecan"},{"type":"DRUG","name":"Ribociclib (Dose #2)"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Inavolisib (Dose #2)"},{"type":"DRUG","name":"Empagliflozin"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Metformin"},{"type":"DRUG","name":"Atirmociclib"},{"type":"DRUG","name":"Giredestrant"}],"enrollment":1132,"startDate":"2018-03-30","completionDate":"2030-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nPatients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):\n\n* Age \\>/= 18 years at the time of signing Informed Consent Form\n* Eastern cooperative oncology group (ECOG) performance status of 0 or 1\n* Able to comply with the study protocol, in the investigator's judgment\n* Metastatic or inoperable locally advanced adenocarcinoma of the breast\n* Measurable disease (at least one target lesion) according to RECIST v1.1\n* Life expectancy \\>/= 3 months, as determined by the investigator\n* Tumor accessible for biopsy, unless archival tissue is available\n* Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm\n\nExclusion Criteria\n\nExclusion Criteria for Stage 1\n\n* Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds\n* Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study\n* Eligibility only for the control arm\n\nExclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort)\n\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade \\</= 1 or better with the exception of alopecia of any grade and Grade \\</= 2 peripheral neuropathy\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* History of leptomeningeal disease\n* Active or history of autoimmune disease or immune deficiency\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.\n* Active tuberculosis\n* Severe infection within 4 weeks prior to initiation of study treatment\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n* Significant cardiovascular disease\n* Prior allogeneic stem cell or solid organ transplantation\n* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study","locations":[{"facility":"City of Hope - Duarte","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"City of Hope - Orange County Lennar Foundation Cancer Center","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego Medical Center","city":"La Jolla","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UCLA Health 200 Medical Plaza","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute","city":"Stanford","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Center - Longmont","city":"Longmont","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"H. Lee Moffitt Cancer Center and Research Inst.","city":"Tampa","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"City of Hope® Cancer Center Chicago","city":"Zion","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro-Minnesota Community Oncology Research Consortium","city":"Saint Paul","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists - Midwest Cancer Center - Legacy","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Univ Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Regional Cancer Care Associates, LLC","city":"Howell Township","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"NYU Langone Medical Center","city":"New York","state":"New York","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Tennessee Oncology - Chattanooga Oncology & Hematology Associates","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The West Clinic","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology PLLC","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology-Plano East","city":"Plano","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre-East Melbourne","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital - Medical Oncology","city":"Murdoch","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Léon Bérard","city":"Lyon","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Institut régional du Cancer Montpellier","city":"Montpellier","state":"","country":"France","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Institut Universitaire du Cancer de Toulouse-Oncopole","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Erlangen","city":"Erlangen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Essen","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Medical Center","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah University Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin MC","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel-Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assuta Medical Centers","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Clinical Trials Center / Center for Breast Cancer","city":"Goyang-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"Sevilla","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital del Mar","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall d?Hebron Institute of Oncology (VHIO), Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Integral Oncológico Clara Campal Ensayos Clínicos START","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beatson West of Scotland Cancer Centre","city":"Glasgow","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Barts Health NHS Trust - St Bartholomew's Hospital","city":"London","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CO40115 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan","empagliflozin","palbociclib"],"locationSlugs":["duarte-california","irvine-california","la-jolla-california","los-angeles-california","stanford-california","longmont-colorado","tampa-florida","zion-illinois","saint-paul-minnesota","omaha-nebraska","reno-nevada","hackensack-new-jersey","howell-township-new-jersey","new-brunswick-new-jersey","new-york-new-york","durham-north-carolina","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","chattanooga-tennessee","germantown-tennessee","nashville-tennessee","plano-texas","melbourne-australia","murdoch-australia","lyon-france","montpellier-france","toulouse-france","villejuif-france","erlangen-germany","essen-germany","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","goyang-si-south-korea","seoul-south-korea","seville-spain","barcelona-spain","madrid-spain","tainan-taiwan","taipei-taiwan","glasgow-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Capecitabine for Metastatic Breast Cancer","inPlainEnglish":"This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.","whoItsFor":["Ages 18 Years to any","Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):","Eastern cooperative oncology group (ECOG) performance status of 0 or 1","Able to comply with the study protocol, in the investigator's judgment","Metastatic or inoperable locally advanced adenocarcinoma of the breast","Measurable disease (at least one target lesion) according to RECIST v1.1","Life expectancy \\>/= 3 months, as determined by the investigator","Tumor accessible for biopsy, unless archival tissue is available"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Capecitabine, Atezolizumab, or Ipatasertib. The registry lists allocation as randomized. This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 1,132 people at 55 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.338Z"},{"nctId":"NCT03429036","title":"Biospecimen Procurement for Head and Neck Disorders","officialTitle":"Biospecimen Procurement for the Study of Head and Neck Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nResearchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments. To do this, they are collecting tissue samples for research.\n\nObjective:\n\nTo create a repository of tissue samples and data to better study conditions of the head and neck.\n\nEligibility:\n\nPeople who had or will have tissue samples taken because of a head or neck disorder. They must be ages 3 and older and not pregnant to join Part 2.\n\nDesign:\n\nParticipants will be screened with a questionnaire, medical history, and physical exam.\n\nPart 1. Participants will give permission for any of their tissue samples leftover from private care or other research protocols to be used.\n\nIf participants tissue did not contain normal tissue or if they have a condition that suggests a genetic issue, they will be invited to join Part 2.\n\nPart 2: Participants will have additional samples collected. These could be:\n\n* Blood: Blood is drawn through a needle in the arm.\n* Cheek swab or brushing: A cotton swab or small brush is rubbed inside the cheek.\n* Saliva: They rinse their mouth with water and spit into a tube or cup.\n* Skin biopsy: They are injected with a numbing drug. A biopsy tool removes a small piece of skin.\n* Mucosal biopsy: They are injected in the mouth with a numbing medication. A small piece of tissue from the inside of the cheek is removed.\n\nParticipants samples will be used for future research, including genetic testing.","conditions":["Hearing Disorder","Oral Mucosal Disease","Pharyngeal Neoplasm","Head and Neck Neoplasms","Laryngeal Disease"],"keywords":["Genomic DNA","DNA Banking","Tissue Sample","Saliva","Blood Collection","Natural History"],"interventions":[],"enrollment":1000,"startDate":"2018-05-23","completionDate":"2029-06-03","sex":"ALL","minAge":"3 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Age 3 and older.\n* Able to provide their own consent, or for minors, a parent or guardian is able to consent on their behalf.\n* Diagnosis of a condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol.\n* Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Part 1:\n\n  --Are unwilling to share waste specimens for research purposes\n* Part 2: Additional exclusion criteria for the Part 2 prospective sample collection part of this protocol these criteria may be assessed prior to collection of the samples but will not affect overall eligibility for the trial (i.e., Part 1):\n\n  * have active symptomatic major organ disorders that would increase the risk of biopsy for research, including but not limited to bleeding disorders, ischemic heart disease, a recent myocardial infarction, active congestive heart failure or severe pulmonary dysfunction\n  * have specific medical condition, such as a bleeding tendency where additional biopsies or phlebotomy procedures may increase the participants' risk in participating. This will be determined at the discretion of the principal investigator\n  * Individuals under the age of 18 are excluded from oral mucosal biopsies and skin biopsies","locations":[{"facility":"MedStar Georgetown University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital Sibley Memorial Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"George Washington University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital Broadway Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital Bayview","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital Greenspring","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Suburban Hospital","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Otolaryngology Clinic","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melissa L Wheatley","phone":"(240) 858-3391","email":"wheatleyml@nih.gov"},{"name":"Clint T Allen, M.D.","phone":"(301) 402-4216","email":"clint.allen@nih.gov"}],"primaryOutcomes":["To created a biorepository of diseased and normal tissue specimens for research purposes"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","baltimore-maryland","bethesda-maryland"],"enrichment":{"headline":"Biospecimen Procurement for Head and Neck Disorders","inPlainEnglish":"Background: Researchers want to learn more about head and neck disorders. Understanding these disorders could help them find better treatments.","whoItsFor":["Ages 3 Years to 120 Years","Diagnosis of a condition of the head and neck for which removal of biological specimens was indicated for clinical care or for research purposes under a separate Review Board (IRB) approved protocol"],"whoShouldSkip":["Are unwilling to share waste specimens for research purposes"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 9 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.332Z"},{"nctId":"NCT03435796","title":"Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells","officialTitle":"Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Celgene","sponsorClass":"INDUSTRY","summary":"This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.\n\nParticipants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.","conditions":["Neoplasms"],"keywords":["Long-term follow up","Gene-Modified T Cells","CAR T Cell"],"interventions":[{"type":"GENETIC","name":"Gene-modified (GM) T cell therapy"}],"enrollment":1541,"startDate":"2018-07-19","completionDate":"2043-05-29","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment protocol, as applicable.\n* Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.\n\nExclusion Criteria:\n\nNot Applicable\n\nOther protocol-defined inclusion/exclusion criteria apply","locations":[{"facility":"University of Alabama Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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2 / Phase 3: Gene-modified (GM) T cell therapy for Neoplasms","inPlainEnglish":"This is a prospective study for the long-term follow-up (LTFU) of safety and how well it works for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.","whoItsFor":["The registry does not list clear inclusion rules. Call the study team before assuming you qualify."],"whoShouldSkip":["Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Gene-modified (GM) T cell therapy. The registry lists allocation as na. This is a prospective study for the long-term follow-up (LTFU) of safety and how well it works for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 1,541 people at 225 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.412Z"},{"nctId":"NCT03454035","title":"Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors","officialTitle":"Ulixertinib (BVD-523) in Combination With Palbociclib in Patients With Advanced Solid Tumors With Expansion Cohort in Previously Treated Metastatic Pancreatic Cancer and Metastatic RAS-mutant and NF1-mutant (no BRAFV600 Mutations) Melanoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"UNC Lineberger Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.","conditions":["Tumor, Solid","Pancreatic Cancer","Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ulixertinib"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":45,"startDate":"2018-01-30","completionDate":"2028-02-03","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent (no upper age limit)\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n4. Tumor Eligibility:\n\n   1. Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care\n   2. Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting\n   3. Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:\n\n      * Tumors molecular profiling genetic aberrations: NRASG12/G13/Q61, KRASG12/G13, HRASG12/G13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled.\n      * Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug.\n      * Subjects with RAS-mutant and NF1-mutant (no concurrent BRAFV600 mutations) melanoma that have not taken prior immune checkpoint inhibitors will be allowed if they are not eligible to receive prior immune checkpoint inhibitors due to requirement for immunosuppression\n5. Measurable or non-measurable (but evaluable) disease according to RECIST v1.1 for dose escalating cohorts; measurable disease as per RECIST v1.1 required for expansion cohort\n6. Life expectancy ≥ 12 weeks\n7. Recovered from all reversible acute toxic effects of last anti-cancer treatment (other than alopecia) to ≤Grade 1 or baseline. Patients with baseline neuropathy that is ≤ grade 2 are eligible for enrollment.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to day -6 of ulixertinib\n\n   Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1,500 /mm3 Platelets ≥ 100,000/mm3 Creatinine ≤1.5 x upper limit of normal (ULN) or Calculated creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula Bilirubin ≤ 1.5 x ULN Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x ULN; if tumor involvement of the liver ≤ 5 x ULN\n9. Adequate cardiac function; left ventricular ejection fraction (LVEF) \\>50% as assessed by ultrasound/echocardiography (ECHO) and corrected QT interval (QTc)\n10. Females of childbearing potential must have a negative serum pregnancy test within 3 days prior to day -6 of ulixertinib. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n11. Females of childbearing potential and males must be willing to abstain from heterosexual activity\\* or use effective methods of contraception from the time of informed consent until 120 days after treatment discontinuation. Acceptable contraception methods can be comprised of an intrauterine device (IUD), vasectomy of a female subject's male partner, contraceptive rod implanted into the skin, OR use of two of the following: diaphragm with spermicide (cannot be used in conjunction with cervical cap/spermicide), cervical cap with spermicide (nulliparous women only), contraceptive sponge (nulliparous women only), male condom or female condom (cannot be used together), hormonal contraceptive.\\] \\*Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n12. Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.\n13. Willing to provide archival tissue (if available) and consent to mandatory pretreatment and on-treatment biopsy as deemed safe by the treating physician (expansion cohort only) for research purposes only.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)\n2. Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib\n3. A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR).\n4. Major surgery within 28 days prior to day -6 of ulixertinib\n5. Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4 interaction with the study medications.\n6. Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4 interaction with the study medications\n7. Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to day -6 of ulixertinib; see section 10.3 Appendix C)\n8. Unable or unwilling to discontinue use of any drug known to be a sensitive CYP3A4 substrate with a narrow therapeutic index as defined in the protocol.\n9. Central nervous system metastases are allowed only for patients RAS-mutated and NF1-mutant melanoma cohorts (1) no leptomeningeal disease is present, (2) Intracranial disease is controlled by prior therapies, as evidenced by brain imaging 2 weeks post treatment indicating no new intracranial disease, (3) stable or decreasing dose of steroids is provided patient on ≤ 20mg of prednisone or it's equivalent daily.\n10. Any important medical illness or abnormal laboratory finding that would increase the risk of participating in the study (based on the investigator's judgment)\n11. Psychiatric illness/social situations that would limit compliance with study requirements\n12. Has a known additional malignancy that is active and/or progressive requiring treatment; non-melanoma skin cancers, non-invasive bladder cancer, and carcinoma in situ of the cervix, prior history of prostate cancer provided the patient is not undergoing active systemic treatment other than hormonal therapy and has documented PSA that is undetectable (\\<0.2ng/mL), prostate carcinoma in remission and did not receive systemic treatment, papillary thyroid cancer did not receive adjuvant radioactive iodine, Stage Rai stage 0 Chronic lymphocytic leukemia does not require systemic treatment, lymphoma, hairy-cell leukemia, or myelodysplasia is in complete remission and or other cancer for which the patient has been disease-free for at least two years.\n\n    Has a known additional malignancy that is active and/or progressive requiring treatment.\n13. Impaired GI function or GI disease that may significantly impair absorption (e.g., inflammatory bowel disease (IBD), malabsorption syndrome, small bowel resection, uncontrolled vomiting or diarrhea)\n14. Inability to swallow oral medications\n15. Patients with autoimmune diseases that require systemic corticosteroid treatment \\>20 mg methylprednisolone equivalent.","locations":[{"facility":"Lineberger Comprehensive Cancer Center","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brian Burgess","phone":"919-966-4432","email":"brian_burgess@med.unc.edu"},{"name":"Catherine Griffin","phone":"919-966-4432","email":"catherine_griffin@med.unc.edu"}],"primaryOutcomes":["Maximum Tolerated Dose (MTD)","Overall Survival"],"hasResults":false,"conditionSlugs":["pancreatic-cancer","melanoma"],"drugSlugs":["palbociclib"],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Phase 1: testing Ulixertinib for Tumor, Solid","inPlainEnglish":"This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.","whoItsFor":["Ages 18 Years to 99 Years","Age ≥ 18 years at the time of consent (no upper age limit)","Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2","Dose escalation cohorts: Histologically confirmed advanced solid tumor refractory to standard of care therapy, or for which there is no accepted standard of care","Expansion cohort (at RP2D): metastatic pancreatic cancer or malign melanoma patients who have received at least one line of therapy in the metastatic setting","Expansion cohort (at RP2D) for histologically confirmed unresectable stage III or stage IV melanoma with the following additional eligibility requirements:","Tumors molecular profiling genetic aberrations: NRASG12/G13/Q61, KRASG12/G13, HRASG12/G13, any amplifications of the NRAS, KRAS, or HRAS genes. For NF1 mutations, subjects with loss-of-function NF1mutations and without any BRAFV600 mutations will be enrolled","Documented disease refractory to at least one PD1/PD-L1 inhibitor, defined as disease progression following at least two infusions of the same drug"],"whoShouldSkip":["Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on the study)","Treatment with any cancer-directed therapy (chemotherapy, hormonal therapy, biologic, radiation or immunotherapy, etc.) or investigational drug within 28 days or 5 half-lives (whichever is shorter) prior to day -6 of ulixertinib","A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)","Major surgery within 28 days prior to day -6 of ulixertinib","Not willing to avoid grapefruit, grapefruit juices, grapefruit hybrids, oranges, pummelos, and exotic citrus fruits from 7 days prior to day -6 of ulixertinib and during the entire study due to potential CYP3A4 interaction with the study medications","Intake of any herbal preparations or medications (including, but not limited to, Saint John's Wort and ginkgo biloba) and dietary supplements within 7 days prior to day -6 of ulixertinib due to potential CYP3A4 interaction with the study medications","Unable or unwilling to discontinue use of any drug known to be a strong inhibitor of CYP3A4, CYP1A2 or CYP2D6 or strong inducer of CYP3A4 (prohibited inducers and inhibitors must be discontinued within 2 weeks prior to day -6 of ulixertinib; see section 10.3 Appendix C)"],"whatHappens":"If you join, the listed intervention(s) are Ulixertinib, or Palbociclib. The registry lists allocation as na. This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 45 people at Chapel Hill. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.730Z"},{"nctId":"NCT03478852","title":"Investigating Epilepsy: Screening and Evaluation","officialTitle":"Investigating Epilepsy: Screening and Evaluation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nEpilepsy affects about 1 percent of the U.S. population. Most people with epilepsy respond well to medicine, but some do not. Researchers want people who have diagnosed or suspected epilepsy to participate in ongoing studies. They want to learn more about clinical care for epilepsy. They want fellows and residents to learn more about the care of people with epilepsy.\n\nObjectives:\n\nTo learn more about seizures and find ways to best treat people with drug-resistant epilepsy.\n\nEligibility:\n\nAdults and children ages 8 years and older with diagnosed or suspected epilepsy\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nMedical history\n\nQuestionnaires\n\nParticipants will have many visits. They may be admitted to the hospital for several weeks. Their medication might be stopped or changed.\n\nParticipants will have many tests:\n\nBlood and urine tests\n\nEEG: Wires attached to the head with paste record brain waves. This may be videotaped.\n\nThinking and memory tests\n\nMRI: Participants lie on a table that slides in and out of a tube. They perform simple tasks in the tube.\n\nMEG: Participants lie on a table and place their head in a helmet to record brain waves.\n\nPET scan: Participants lie on a table that slides into a machine. A small amount of radioactive dye is injected into their arm with an IV. For the IV, a small tube is inserted into the arm with a needle.\n\nParticipants will stay enrolled in this study if they join other epilepsy-related studies. They may be contacted at intervals for follow-up. Their participation will end if they have not been seen clinically for their epilepsy for 3 years.","conditions":["Seizures","Epilepsy","Epilepsy, Temporal Lobe","Partial Epilepsy"],"keywords":["Seizure Disorder","Seizures","Antiepileptic Drug","Natural History Study","Screening Protocol"],"interventions":[],"enrollment":1000,"startDate":"2018-03-28","completionDate":"2037-07-31","sex":"ALL","minAge":"8 Years","maxAge":"110 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Age 8 years or older\n* Known or suspected diagnosis of epilepsy\n* Ability to give informed consent or have a legally authorized representative able to give consent (for adults without consent capacity) or parent/guardian able to provide informed consent (for a child)\n* If unable to give informed consent, ability to give verbal assent\n\nEXCLUSION CRITERIA:\n\n* Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol\n* Patients who are unable to travel to the NIH","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aaliyah M HamidullahThiam","phone":"(301) 435-2952","email":"aaliyah.hamidullahthiam@nih.gov"},{"name":"Yasser Tajali, M.D.","phone":"(301) 594-9223","email":"yasser.tajali@nih.gov"}],"primaryOutcomes":["Screening and characterization of patients with drug-resistant epilepsy for epilepsy-related protocols"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Investigating Epilepsy: Screening and Evaluation","inPlainEnglish":"Background: Epilepsy affects about 1 percent of the U.S. Most people with epilepsy respond well to medicine, but some do not.","whoItsFor":["Ages 8 Years to 110 Years","Age 8 years or older","Known or suspected diagnosis of epilepsy"],"whoShouldSkip":["Patients with unstable medical conditions that, in the opinion of the investigators, makes participation unsafe, or who, in the opinion of the investigators may be unable to comply with the protocol","Patients who are unable to travel to the NIH"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.916Z"},{"nctId":"NCT03486873","title":"Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)","officialTitle":"A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.","conditions":["Solid Tumors","Hematologic Malignancies"],"keywords":["PD1","PD-1","PDL1","PD-L1"],"interventions":[{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Standard of Care (SOC)"},{"type":"DRUG","name":"Lenvatinib"},{"type":"DRUG","name":"Olaparib"},{"type":"DRUG","name":"MK-4280"},{"type":"BIOLOGICAL","name":"MK-4280A"},{"type":"BIOLOGICAL","name":"Pembrolizumab (+) Berahyaluronidase alfa"}],"enrollment":3500,"startDate":"2018-08-21","completionDate":"2043-08-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\<150/90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant/breastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and/or carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue/solid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g/24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.","locations":[{"facility":"Arizona Cancer Center at UMC North ( Site 0018)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Comprehensive Blood & Cancer Center [Bakersfield, CA] ( Site 0054)","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Cancer Associates for Research & Excellence ( Site 0016)","city":"Fresno","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Providence Medical Foundation ( Site 0087)","city":"Fullerton","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute ( Site 0005)","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"UCLA - Hematology/Oncology - Administrative Office ( Site 0009)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 0076)","city":"Orange","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Stanford Cancer Center ( Site 0086)","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0004)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint John's Health Center ( Site 0059)","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center ( Site 0021)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Cancer Center ( Site 0014)","city":"New Haven","state":"Connecticut","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Georgetown University Medical Center ( Site 0023)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital, Michael & Dianne Bienes Comp Cancer Ctr ( Site 0022)","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist MD Anderson Cancer Center ( Site 0083)","city":"Jacksonville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mount Sinai Braman Comprehensive Cancer Center ( Site 0031)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center ( Site 0011)","city":"Tampa","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Emory School of Medicine ( Site 0013)","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Augusta University ( Site 0077)","city":"Augusta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northwest Georgia Oncology Centers PC ( Site 0061)","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Moanalua Medical Center ( Site 0063)","city":"Honolulu","state":"Hawaii","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The University of Chicago ( Site 0020)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospital and Clinics ( Site 0026)","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Graham Brown Cancer Center ( Site 0058)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Health-Paducah Cancer Center ( Site 0084)","city":"Paducah","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Cancer Care ( Site 0088)","city":"Covington","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Franklin Square Medical Center ( Site 0046)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0056)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Oncology Hematology (MOH) ( Site 8000)","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital ( Site 0041)","city":"Boston","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute ( Site 0006)","city":"Boston","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute ( Site 0047)","city":"Detroit","state":"Michigan","country":"United 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3: testing Pembrolizumab for Solid Tumors","inPlainEnglish":"This study wants to measure the long-term safety and how well it works of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study. This study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase.","whoItsFor":["Ages 18 Years to any","Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready","Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase","Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:","Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Demonstrates adequate organ function","Additional eligibility criteria for participants who enter dosing with Lenvatinib:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, Standard of Care (SOC), or Lenvatinib. The registry lists allocation as randomized. This study wants to measure the long-term safety and how well it works of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 3,500 people at 782 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.634Z"},{"nctId":"NCT03492671","title":"Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer","officialTitle":"A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Loma Linda University","sponsorClass":"OTHER","summary":"The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.","conditions":["Pancreas Adenocarcinoma","Resectable Pancreatic Cancer"],"keywords":["Pancreatic Cancer"],"interventions":[{"type":"DRUG","name":"Gemcitabine 1000 mg"},{"type":"DRUG","name":"nab-paclitaxel"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy"}],"enrollment":30,"startDate":"2019-07-17","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria (all criteria must apply):\n\n* Cytologic or histologic proof of adenocarcinoma of the pancreas.\n* Localized, potentially resectable tumors.\n* Greater or equal to 18 years of age.\n* ECOG performance status of 0 or 1.\n* Adequate hematologic, renal and hepatic function as defined by:\n* ANC greater or equal to 1,500 cells/mm3\n* Platelets greater or equal to 100,000 cells/mm3\n* Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN\n* AST ≤ 5 x ULN\n* No history of prior therapy for pancreatic cancer.\n* No history of active infection requiring IV antibiotics at the start of study treatment\n* Non-pregnant and non-breast-feeding.\n\nExclusion Criteria:\n\n* Patient has borderline resectable or metastatic disease.\n* History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.\n* Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.","locations":[{"facility":"Loma Linda University Health","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naveenraj Solomon, MD","phone":"909-558-5498","email":"nsolomon@llu.edu"},{"name":"Shagufta Shaheen, MD","phone":"909-558-4050","email":"sshaheen@llu.edu"}],"primaryOutcomes":["Curative Intent Resection (R0) rate"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["loma-linda-california"],"enrichment":{"headline":"Phase 2: testing Gemcitabine 1000 mg for Pancreas Adenocarcinoma","inPlainEnglish":"The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel.","whoItsFor":["Ages 18 Years to any","(all criteria must apply):","Cytologic or histologic proof of adenocarcinoma of the pancreas","Localized, potentially resectable tumors","Greater or equal to 18 years of age","how well you can do daily activities (ECOG score) of 0 or 1","Adequate hematologic, renal and hepatic function as defined by:","ANC greater or equal to 1,500 cells/mm3"],"whoShouldSkip":["Patient has borderline resectable or metastatic disease","History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years","Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy"],"whatHappens":"If you join, the listed intervention(s) are Gemcitabine 1000 mg, nab-paclitaxel, or Stereotactic Body Radiation Therapy. The registry lists allocation as na. The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Loma Linda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.437Z"},{"nctId":"NCT03510442","title":"Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions","officialTitle":"Investigation of the Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease and Related Inflammatory Conditions","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","sponsorClass":"NIH","summary":"Background:\n\nInflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic juvenile idiopathic arthritis (sJIA) is one of these conditions. So is adult-onset Still s disease (AOSD). Their causes are unknown. Researchers want to learn more about these conditions. This includes genetic changes and environmental factors.\n\nObjective:\n\nTo study sJIA and AOSD in children and adults over time.\n\nEligibility:\n\nPeople with known or suspected sJIA, AOSD, or similar inflammatory condition\n\nDesign:\n\nParticipants will be screened with a phone call.\n\nParticipants will have 1 visit. It may be outpatient or they may be admitted to the clinic. The visit may last up to 5 days. Participants will have:\n\n* Medical history\n* Physical exam\n* Musculoskeletal exam\n* Questions about overall health and quality of life, disease activity, functional status, and cognitive ability.\n\nParticipants may also have:\n\n* Pictures taken of their skin, joints, or spine\n* Blood, urine, and stool tests\n* Scans or X-rays of joints with arthritis\n* Chest X-ray\n* Heart tests\n* Skin biopsy. The skin will be numbed. The top layers of a small area will be scraped off.\n\nParticipants who have a joint aspiration may provide a fluid sample. The joint will be prepared, then fluid is removed by needle. A corticosteroid may be injected.\n\nParticipants who have a bone marrow biopsy may provide sample cells.\n\nParticipants may be seen by NIH specialists.\n\nMembers of the participant s family and healthy volunteers may give blood or saliva samples for genetic testing.\n\nParticipants may repeat some study tests every 6 months.","conditions":["Still's Disease, Adult-Onset","Systemic Inflammation","Arthritis","Autoinflammatory Syndrome"],"keywords":["Inflammation","Fever","Arthritis","Sequencing","Natural History"],"interventions":[],"enrollment":2000,"startDate":"2018-05-21","completionDate":"2050-01-01","sex":"ALL","minAge":"1 Day","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAffected subject:\n\n* Patients with signs and symptoms of sJIA will be classified as outlined in Diagnosis/Classification Criteria.\n\n  1. Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA.\n  2. Patients 16 years of age and older will be considered to have sJIA if they have previously met ILAR criteria for sJIA.\n* Patients with signs and symptoms of AOSD will be classified as outlined in Yamaguchi Criteria for diagnosing Adult-Onset Still's Disease.\n\n  1. Patients 16 years of age and older will be considered to have AOSD if they meet the Yamaguchi criteria for AOSD (including a negative ANA and RF).\n  2. Patients may be considered to have a diagnosis of AOSD if they met criteria for diagnosis in the past but do not still have present evidence of disease.\n  3. Pregnant people with still's disease are allowed to enroll. Pregnant people will not be asked to submit to a skin biopsy or bone marrow aspiration.\n* The minimum age for participation in this study is between 0 and older.\n\nHealthy Subjects:\n\n1. Healthy Volunteers related to individuals included under items 1 and 2 above will be enrolled.\n2. Unrelated healthy volunteers will be enrolled for clinical, cellular, molecular, and biochemical assays, and genetic evaluation. Individuals who undergo phlebotomy specifically to provide a control specimen will include both pediatric and adult patients and will not be pregnant.\n3. Healthy Volunteer should not have any history of autoimmune, autoinflammatory, rheumatic or proliferative/malignant disease or any unexplained inflammatory signs/symptoms or conditions (applies to unrelated).\n\n   * The minimum age for participation in this study under this cohort is 2 years.\n\nEXCLUSION CRITERIA:\n\nAffected and Healthy subjects:\n\n1. In adults, inability, or the lack of capacity to provide informed consent. In the case of minors, unavailability of a parent or guardian.\n2. Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study.\n3. Unavailability, or inability to adhere with the schedule for follow-up visits","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle R Millwood","phone":"(301) 827-1849","email":"millwoodmr@mail.nih.gov"},{"name":"Michael J Ombrello, M.D.","phone":"(301) 435-4037","email":"ombrellomj@mail.nih.gov"}],"primaryOutcomes":["Genetic sequencing of patients"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still…","inPlainEnglish":"Background: Inflammatory conditions can cause symptoms like fevers, arthritis, and rash. Systemic juvenile idiopathic arthritis (sJIA) is one of these conditions.","whoItsFor":["Ages 1 Day to 100 Years","Patients with signs and symptoms of sJIA will be classified as outlined in Diagnosis/Classification Criteria","Patients less than 16 years of age will be considered to have sJIA if they meet the ILAR criteria for sJIA","Patients 16 years of age and older will be considered to have sJIA if they have previously met ILAR criteria for sJIA","Patients with signs and symptoms of AOSD will be classified as outlined in Yamaguchi Criteria for diagnosing Adult-Onset Still's Disease","Patients 16 years of age and older will be considered to have AOSD if they meet the Yamaguchi criteria for AOSD (including a negative ANA and RF)","Patients may be considered to have a diagnosis of AOSD if they met criteria for diagnosis in the past but do not still have present evidence of disease","Pregnant people with still's disease are allowed to enroll. Pregnant people will not be asked to submit to a skin biopsy or bone marrow aspiration"],"whoShouldSkip":["Affected and Healthy subjects:","Presence of any medical condition that would, in the opinion of the investigators, confuse the interpretation of the study","Unavailability, or inability to adhere with the schedule for follow-up visits"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.963Z"},{"nctId":"NCT03572465","title":"Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis","officialTitle":"Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","sponsorClass":"OTHER","summary":"Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH). If left untreated, NASH can evolve to cirrhosis, the late stage of fibrosis. Once cirrhosis is established, patients are at increased risk of developing gastrointestinal bleeding, liver cancer and liver failure that may require transplantation. A liver biopsy is currently needed to diagnose the severity of fatty liver disease but this is usually not indicated in asymptomatic patients. This procedure requires the insertion of a needle inside the liver to remove a small piece of tissue for examination under microscope. Liver biopsy is an invasive procedure with a small risk of major complications such as bleeding in 0.5% of cases. It is also affected by sub-optimal sampling leading to diagnostic errors\n\nUltrasound is optimum for screening patients with or without symptoms because it is a safe and widely available technology to scan the whole liver. Members of our team have developed Advanced ultrasound techniques that provide unique information not possible with state-of-the-art techniques. Unlike liver biopsy, these techniques would be applicable even in asymptomatic patients because it is non-invasive. This research proposal proposes a novel approach for diagnosis of NASH and will be the first study to measure individual components of NASH (fat, inflammation and fibrosis) with quantitative ultrasound (QUS) scores. This study is timely because NASH is the second leading cause of liver transplantation in North America and is predicted to become the leading indication in the near future.","conditions":["Nonalcoholic Fatty Liver Disease (NAFLD)","Nonalcoholic Steatohepatitis (NASH)"],"keywords":["Chronic liver disease","Fibrosis","Elastography","Ultrasound","Magnetic resonance elastography","Diagnostic performance","Sensitivity and specificity"],"interventions":[{"type":"DEVICE","name":"Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)"}],"enrollment":102,"startDate":"2019-10-23","completionDate":"2026-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Are at least 18 years old at screening;\n* Able to comprehend and willingness to provide voluntary consent;\n* Understand French or English;\n* NAFLD/NASH subjects:\n\n  * Have a suspected or known NAFLD or NASH;\n  * Must undergo a liver biopsy as part of their clinical standard of care\n* Non-NAFLD volunteers:\n\n  * Do not have a suspected or known NAFLD or NASH\n\nExclusion Criteria:\n\n* Are pregnant or trying to become pregnant;\n* Have a weight or girth preventing them from entering the MR magnet bore;\n* Are unable to understand or unwilling to provide written informed consent for this study;\n* Non-NAFLD volunteers:\n\n  * Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption \\>60g of alcohol per day, lipogenic medication and body mass index \\>25 kg/m2);\n  * Have a liver steatosis (defined as MRI-proton density fat fraction \\<5%);\n* NAFLD/NASH subjects:\n\n  * Have other causes of chronic liver disease;\n  * Have a liver transplant","locations":[{"facility":"Centre Hospitalier de l'Université de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"An Tang, MD, MSc","phone":"514-890-8000","email":"an.tang@umontreal.ca"},{"name":"Assia Belblidia","phone":"514-890-8000","email":"assia.belblidia.chum@ssss.gouv.qc.ca"}],"primaryOutcomes":["Fibrosis stage"],"hasResults":false,"conditionSlugs":["liver-cancer","als","type-2-diabetes","obesity","fatty-liver"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE) for Nonalcoholic Fatty Liver Disease (NAFLD)","inPlainEnglish":"Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).","whoItsFor":["Ages 18 Years to any","Are at least 18 years old at screening;","Able to comprehend and willingness to provide voluntary consent;","Understand French or English;","NAFLD/NASH subjects:","Have a suspected or known NAFLD or NASH;","Must undergo a liver biopsy as part of their clinical standard of care","Non-NAFLD volunteers:"],"whoShouldSkip":["Are pregnant or trying to become pregnant;","Have a weight or girth preventing them from entering the MR magnet bore;","Non-NAFLD volunteers:","Have risk factors for developing liver steatosis (type 2 diabetes mellitus, alcohol consumption \\>60g of alcohol per day, lipogenic medication and body mass index \\>25 kg/m2);","Have a liver steatosis (defined as MRI-proton density fat fraction \\<5%);","NAFLD/NASH subjects:","Have other causes of chronic liver disease;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 102 people at Montreal. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.171Z"},{"nctId":"NCT03589729","title":"Dexrazoxane Hydrochloride in Preventing Heart-Related Side Effects of Chemotherapy in Participants With Blood Cancers","officialTitle":"Cardioprotection With Dexrazoxane in Acute Myeloid Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS), Myeloid Blast Phase of Chronic Myeloid Leukemia (CML), Ph+ AML, and Myeloid Blast Phase of Myeloproliferative Neoplasms","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.","conditions":["Acute Myeloid Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Myeloid Sarcoma","Myeloproliferative Neoplasm","Philadelphia Chromosome Positive"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cladribine"},{"type":"DRUG","name":"Cytarabine"},{"type":"DRUG","name":"Dexrazoxane Hydrochloride"},{"type":"DRUG","name":"Gemtuzumab Ozogamicin"},{"type":"DRUG","name":"Idarubicin"}],"enrollment":100,"startDate":"2018-09-19","completionDate":"2027-12-31","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan.\n* Patients of child bearing potential should use contraception.\n* Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible.\n* Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible.\n* Patients with myeloproliferative neoplasms in blast phase will be eligible.\n* Patients with isolated extramedullary myeloid neoplasm will be eligible.\n* Patients with active CNS (central nervous system) disease are eligible.\n* Bilirubin \\< 2mg/dL.\n* AST (aspartate aminotransferase) and/or ALT (alanine aminotransferase) \\< 3 x ULN (upper limit of normal) - or \\< 5 x ULN if related to leukemic involvement.\n* Creatinine \\< 1.5 x ULN.\n* Hyperbilirubinemia is allowed if due to Gilbert's hyperbilirubinemia.\n* A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n* Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.\n* Prior therapy for any of the cohorts may include with hydroxyurea, rescue doses of cytarabine, various combination-chemotherapy regimens, hematopoietic growth factors, azacytidine, decitabine, ATRA (all-trans retinoic acid).\n* Cohort 1: Frontline cohort patients are eligible in the frontline cohort if they are untreated or previously treated already in CR if they received 3 or fewer cycles of previous chemotherapy (including either 1 induction and 2 consolidations or 2 inductions and 1 consolidation).\n* Cohort 2: Salvage cohort in 1st and 2nd salvage patients are eligible in the salvage cohort 2 if they have active disease after first or second relapse or if they are in CR after previously documented first or second relapse as long as they if they have received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 3: Salvage cohort in 3rd salvage and beyond patients may be eligible in salvage cohort 3 if they have active disease after 3rd or greater relapse or if they are in CR after a previously documented relapse (3rd or greater), but may have only received 3 or fewer cycles of chemotherapy to achieve the most current CR.\n* Cohort 4: Maintenance cohort: Patients in CR who are considered by treating physician to benefit from maintenance therapy are eligible for maintenance therapy with dexrazoxane combined with idarubicin plus cytarabine.\n\nExclusion Criteria:\n\n* Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk.\n* Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months.\n* Decompensated heart failure (HF).\n* Clinically significant arrhythmias.\n* Severe valvular disease.\n* History of coronary artery disease (CAD).\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n* Psychiatric illness/social situations that would limit compliance with study requirements per the judgment of the investigator.\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n* Men and women of childbearing potential who do not practice contraception.","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maro Ohanian","phone":"713-792-2631","email":"mohanian@mdanderson.org"}],"primaryOutcomes":["Percentage of patients experiencing a decrease in left ventricular ejection fraction (LVEF)"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Cladribine for Acute Myeloid Leukemia","inPlainEnglish":"This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms. Chemoprotective drugs, such as dexrazoxane hydrochloride, may protect the heart from the side effects of drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and gemtuzumab ozogamicin, in participants with blood cancers.","whoItsFor":["Ages 12 Years to any","Baseline left ventricular ejection fraction (LVEF) is greater than or equal to 50% by echocardiography (echo) or multigated acquisition (MUGA) scan","Patients of child bearing potential should use contraception","Patients with a diagnosis of acute myeloid leukemia (AML), or high risk myelodysplastic syndrome (MDS) (\\>= 10% blasts or International Prognostic Scoring System \\[IPSS\\] \\>= intermediate-2) or high-risk myeloproliferative neoplasm will be eligible","Patients with untreated or previously untreated chronic myeloid leukemia (CML) in myeloid blast phase or (Philadelphia chromosome-positive (Ph+) AML are also eligible","Patients with myeloproliferative neoplasms in blast phase will be eligible","Patients with isolated extramedullary myeloid neoplasm will be eligible","Patients with active CNS (central nervous system) disease are eligible"],"whoShouldSkip":["Any condition, including the presence of laboratory abnormalities, which judged by the investigator, places the patient at unacceptable risk","Active heart disease defined as: Unstable coronary syndromes, unstable or severe angina, recent myocardial infarction (MI) within 6 months","Decompensated heart failure (HF)","Clinically significant arrhythmias","Severe valvular disease","History of coronary artery disease (CAD)","Psychiatric illness/social situations that would limit compliance with study requirements per the judgment of the investigator"],"whatHappens":"If you join, the listed intervention(s) are Cladribine, Cytarabine, or Dexrazoxane Hydrochloride. The registry lists allocation as na. This phase II trial studies how well dexrazoxane hydrochloride works in preventing heart-related side effects of chemotherapy in participants with blood cancers, such as acute myeloid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, and myeloproliferative neoplasms.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.815Z"},{"nctId":"NCT03618550","title":"Phase II Study of Second- Line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","officialTitle":"Phase II Study of Second-line Pembrolizumab Plus GVD for Relapsed or Refractory Hodgkin Lymphoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.","conditions":["Hodgkin Lymphoma","Relapsed or Refractory Hodgkin Lymphoma"],"keywords":["Pembrolizumab","GVD","18-160"],"interventions":[{"type":"DRUG","name":"pembrolizumab"},{"type":"DRUG","name":"gemcitabine"},{"type":"DRUG","name":"vinorelbine"},{"type":"DRUG","name":"liposomal doxorubicin"},{"type":"PROCEDURE","name":"Stem cell mobilization and collection"},{"type":"RADIATION","name":"Involved-site radiation therapy"}],"enrollment":257,"startDate":"2018-08-01","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution.\n* Be willing and able to provide written informed consent/assent for the trial.\n* Be ≥ 18 years of age on day of signing informed consent.\n* PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria\n* Have a performance status of 0 or 1 on the ECOG Performance Scale\n* Demonstrate adequate organ function as defined in table below\n* Demonstrate adequate organ function as defined in table below. Hematological\\*\n* Absolute neutrophil count (ANC) ≥1000 /mcL\n* Platelets ≥50,000 / mcL\n* Hemoglobin ≥8 g/dL Renal\n* Serum creatinine OR ≤1.5 X upper limit of normal (ULN) OR\n* Measured or calculated creatinine clearance (eGFR can also be used in place of creatinine) ≥60 mL/min for subject with creatinine levels \\> 1.5 X institutional ULN Hepatic\\*\n* Serum total bilirubin ≤ 1.5 X ULN OR ≤ 3 X ULN for subjects with liver metastases\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases Pulmonary\n* Hemoglobin-adjusted diffusing capacity for carbon monoxide ≥50% (If unadjusted DLCO is \\>/= 50% then there is no need to calculate adjusted) Cardiac\n* Ejection fraction ≥45% Coagulation\n* International normalized ratio (INR) OR prothrombin time (PT), Activated partial thromboplastin time (aPTT): ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n\n  \\*Lab values for eligibility should be based upon labs prior to Cycle 1 treatment of Pembro-GVD.\n* Female subject of childbearing potential should have a negative urine or serum pregnancy within 2 weeks prior to receiving the first dose of study medication. On the day of planned treatment, if a blood pregnancy test has not been performed within the two week window, a stat pregnancy test (urine or blood) should be performed and the results reviewed before treatment is begun.\n* Female subjects of childbearing potential must be willing to use an adequate method of contraception (see details in section 11.4.3).\n* Male subjects of childbearing potential must agree to use an adequate method of contraception.(see details in section 11.4.3).\n* HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n  * Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening\n  * Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening\n  * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months.\n  * Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.\n\nExclusion Criteria:\n\n* Known pregnancy or breast-feeding.\n\n  * Breast-feeding should be discontinued prior to treatment initiation.\n* Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate.\n* Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.\n* Has a history of pneumonitis related to PD-1 blockade that required steroids.\n* Has an active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications\n* Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had an allogeneic hematopoietic transplant greater than 5 years ago are eligible as long as there are no symptoms of GVHD.)\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","locations":[{"facility":"City of Hope Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University Medical Center","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Basking Ridge","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center @ Commack","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alison Moskowitz, MD","phone":"212-639-4839","email":"moskowia@mskcc.org"},{"name":"Heiko Schoder, MD","phone":"212-639-2079","email":""}],"primaryOutcomes":["Complete response rate (part 1)","Assess freedom from disease at 5 years (part 3)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":["pembrolizumab"],"locationSlugs":["duarte-california","stanford-california","miami-florida","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york"],"enrichment":{"headline":"Phase 2: testing pembrolizumab for Hodgkin Lymphoma","inPlainEnglish":"This study wants to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.","whoItsFor":["Ages 18 Years to any","Histologic diagnosis of classical Hodgkin's lymphoma. Primary refractory or relapsed disease proven by biopsy at enrolling institution","PET scan before initiating pembro-GVD have measurable disease based on Lugano 2014 criteria","Have a performance status of 0 or 1 on the ECOG Performance Scale","Demonstrate adequate organ function as defined in table below","Demonstrate adequate organ function as defined in table below. Hematological\\*","Absolute neutrophil count (ANC) ≥1000 /mcL","Platelets ≥50,000 / mcL"],"whoShouldSkip":["Known pregnancy or breast-feeding","Breast-feeding should be discontinued prior to treatment initiation","Medical illness unrelated to Hodgkin's Lymphoma, which, in the opinion of the attending physician and/or principal investigator, makes participation in this study inappropriate","Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis","Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis","Has known active HIV, Hepatitis B (e.g., Hepatitis B PCR positive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected)","Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed"],"whatHappens":"If you join, the listed intervention(s) are pembrolizumab, gemcitabine, or vinorelbine. The registry lists allocation as randomized. This study wants to test any good and bad effects of the study drug, pembrolizumab, in combination with GVD in the treatment of Hodgkin lymphoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 257 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.143Z"},{"nctId":"NCT03635541","title":"Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease","officialTitle":"Dynamic Changes and Risk Factors of Fibrosis and Steatosis Progression in Nonalcoholic Fatty Liver Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Beijing Friendship Hospital","sponsorClass":"OTHER","summary":"It is an observational study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 500. Liver biopsy proved NAFLD patients will be recruited in this study for 10 years follow-up. Patients will be assessed at baseline, at every six months for blood count, liver function test, fasting blood-glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness.","conditions":["Non-Alcoholic Fatty Liver Disease"],"keywords":["non alcoholic fatty liver disease","non alcoholic steatohepatitis","steatosis","fibrosis","progression","risk factors"],"interventions":[{"type":"OTHER","name":"observational group of NAFLD"}],"enrollment":500,"startDate":"2018-08-23","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. 18-70 years of age, 2. liver biopsy proven non alcoholic fatty liver disease. 3. Agree to be followed up regularly; 4. Signature of written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease.\n\n  2\\. Patients undergone bariatric surgery. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:\n  1. Hepatocellular carcinoma or suspected liver cancer,\n  2. Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;\n  3. Other malignancy,\n  4. Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study.","locations":[{"facility":"Beijing Friendship Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hong You, Doctor","phone":"861063139019","email":"youhong30@sina.com"},{"name":"Jidong Jia, Doctor","phone":"861063139816","email":"jiamd@263.net"}],"primaryOutcomes":["fibrosis progrssion","steatosis progression"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: observational group of NAFLD for Non-Alcoholic Fatty Liver Disease","inPlainEnglish":"It is an watch-and-measure (no experimental treatment required) study of non alcoholic fatty liver disease (NAFLD) patients with a calculated sample size of 500. Liver biopsy proved NAFLD patients will be recruited in this study for 10 years follow-up.","whoItsFor":["Ages 18 Years to 70 Years"],"whoShouldSkip":["1\\. Patients with other liver diseases including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, drug induced liver diseases, genetic metabolic liver disease","2\\. Patients undergone bariatric surgery. 3. HIV infected patients. 4. Pregnant women. 5. Patients with severe diseases with expected survival less than 2 years. 6. Patients had followings before liver biopsy:","Hepatocellular carcinoma or suspected liver cancer,","Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;","Undergone liver transplantation surgery. 7.Patients with any other reasons not suitable for the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.171Z"},{"nctId":"NCT03681561","title":"Nivolumab With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma","officialTitle":"Phase I/II Study of Nivolumab in Combination With Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Veronika Bachanova","sponsorClass":"OTHER","summary":"This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to evaluate the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).","conditions":["Hodgkin Lymphoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ruxolitinib"},{"type":"DRUG","name":"Nivolumab"}],"enrollment":54,"startDate":"2018-09-13","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 18 years at the time of consent.\n* ECOG Performance Status of 0, 1 or 2.\n* Histologically confirmed diagnosis of classical Hodgkin lymphoma that is relapsed or refractory - historical biopsy at last relapse is acceptable. NOTE: a repeat biopsy is not required for Phase I if the historical biopsy was performed at the most recent relapse, without remission in between. A fresh biopsy is not required for Phase II.\n* Presence of radiographically measurable disease (defined as the presence one or more ≥ 1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of study registration.\n* Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and subsequent progressive disease, stable disease, mixed response, or relapse\n* Failed at least one prior therapy\n* Prior cancer treatment must be completed at least 14 days prior to registration and the patient must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤Grade 1 or baseline. Radiation therapy must be completed at least 7 days prior to registration.\n* Absolute Neutrophil Count ≥ 1000/μL\n* Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)\n* Calculated creatinine clearance ≥ 40 cc/min using the Cockcroft-Gault formula\n* Bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration. NOTE: Females are considered of child bearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months\n* Males who are sexually active with partners of child-bearing potential must be willing to abstain from heterosexual activity or adhere to contraception from the time of written consent until 7 months after treatment discontinuation.\n* Patient must provide voluntary written informed consent prior to the performance of any research related tests or procedures.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n* Inability or unwillingness to swallow oral medication or any condition that precludes the administration and/or absorption of oral medications\n* A life-threatening illness, medical condition or organ system dysfunction, which in the investigator's opinion, could compromise the patient's safety, interfere with the metabolism of study drugs, or put the study outcomes at undue risk\n* Active central nervous system (CNS) involvement by lymphoma\n* Uncontrolled cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Concomitant therapy with immunosuppressive agents, including systemic corticosteroids (doses ≤ 10 mg/day prednisone or equivalent are permitted).\n* Has a history of autoimmune disease now or in past 3 years such as hepatitis, nephritis, hyperthyroidism, interstitial lung disease or colitis except vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* Active Hepatitis B or C infection (defined as a positive Hepatitis B surface antigen (Ag) or detectable viral load by PCR). NOTES: Hepatitis B and C testing is required. Patients with positive Hepatitis B Ag may enroll if PCR is negative. Suppressive antiviral therapy should be considered for these patients as clinically indicated.\n* Currently active, clinically significant hepatic impairment Child-Pugh class B or C\n* Currently receiving a strong CYP3A4 Inhibitor (such as but not limited to boceprevir clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole) or Fluconazole \\>200 mg/day. Washout period of 1 week is required.\n* History of stroke or intracranial hemorrhage within 6 months of study registration","locations":[{"facility":"University of Illinois Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Indiana Melvin and Bren Simon Comprehensive Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Veronika Bachanova","phone":"612-625-5469","email":"bach0173@umn.edu"},{"name":"Ahran Lee","phone":"317-634-5842","email":"alee@hoosiercancer.org"}],"primaryOutcomes":["Maximum Tolerated Dose","Overall Disease Control"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":["nivolumab"],"locationSlugs":["chicago-illinois","indianapolis-indiana","iowa-city-iowa","minneapolis-minnesota","columbus-ohio","madison-wisconsin"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Ruxolitinib for Hodgkin Lymphoma","inPlainEnglish":"This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to measure the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years at the time of consent","how well you can do daily activities (ECOG score) of 0, 1 or 2","Presence of radiographically measurable disease (defined as the presence one or more ≥ 1.5 cm lesions, as measured in the longest dimension by PET/CT) within 4 weeks of study registration","Prior therapy with check-point inhibitors (nivolumab, pembrolizumab, others) and subsequent progressive disease, stable disease, mixed response, or relapse","Failed at least one prior therapy","Absolute Neutrophil Count ≥ 1000/μL","Platelets ≥ 75,000/μL (or ≥50,000/mm3 if known BM involvement)"],"whoShouldSkip":["Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)","Inability or unwillingness to swallow oral medication or any condition that precludes the administration and/or absorption of oral medications","A life-threatening illness, medical condition or organ system dysfunction, which in the investigator's opinion, could compromise the patient's safety, interfere with the metabolism of study drugs, or put the study outcomes at undue risk","Active central nervous system (CNS) involvement by lymphoma","Uncontrolled cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction or any class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification","Concomitant therapy with immunosuppressive agents, including systemic corticosteroids (doses ≤ 10 mg/day prednisone or equivalent are permitted)","HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial"],"whatHappens":"If you join, the listed intervention(s) are Ruxolitinib, or Nivolumab. The registry lists allocation as randomized. This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to measure the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.013Z"},{"nctId":"NCT03683251","title":"Extension Study for the Port Delivery System With Ranibizumab (Portal)","officialTitle":"A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration (Portal)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study will evaluate the long-term safety and tolerability of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomized in WR42221.","conditions":["Neovascular Age-Related Macular Degeneration"],"keywords":[],"interventions":[{"type":"DRUG","name":"PDS Implant with Ranibizumab 100 mg/mL"}],"enrollment":1000,"startDate":"2018-09-20","completionDate":"2029-12-31","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Previous enrollment in and completion of Study GX28228 (Ladder) or Study GR40548 (Archway), without early treatment or study discontinuation in either study OR Previous enrollment in Study WR42221 (Velodrome) and either not eligible to be randomized in Study WR42221 at Week 24 or completed the study (from the Q24W or Q36W arm)\n* Ability and willingness to undertake all scheduled visits and assessments\n* For women of childbearing potential: agreement to remain abstinent or use contraceptive measures\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab\n* History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications\n* History of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the Implant and that might affect interpretation of the results of the study or that renders the participant at high risk of treatment complications\n* Requirement for continuous use of any medications or treatments indicated in the \"Prohibited Therapy\"\n\nSub-study 1\n\nInclusion Criteria\n\n\\- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures\n\nParticipants must meet the following ocular criteria for the study eye for substudy entry:\n\n* Diagnosis of exudative nAMD within 2 years prior to the enrollment visit\n* Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit\n* Demonstrated response to prior anti-VEGF ITV treatment since diagnosis, as evidenced at enrollment by the following:\n\nOverall decrease in nAMD disease activity detected on SD-OCT AND Stable or improved best-corrected visual acuity (BCVA)\n\n* All subtypes of nAMD lesions are permissible (i.e., type I, type II, type III, or mixed forms per optical coherence tomography (OCT) classification) nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea).\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of FP and SD-OCT images.\n\nExclusion Criteria Prior Ocular Treatments Study Eye\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD\n* Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy\n* Previous treatment with corticosteroid ITV injection\n* Previous intraocular device implantation\n* Previous laser (any type) used for AMD treatment\n\nEither Eye\n\n* Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit\n* Prior participation in a clinical trial involving anti-VEGF drugs within 6 months prior to the enrollment visit, other than ranibizumab\n\nCNV Lesion Charateristics Study Eye\n\n* Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area (1.27 mm2 ) in size at screening\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye\n\n\\- CNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia\n\nConcurrent Ocular Conditions Study Eye\n\n* Retinal pigment epithelial tear\n* Any concurrent intraocular condition (e.g., cataract, glaucoma, diabetic retinopathy, or epiretinal membrane) that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Active intraocular inflammation (grade trace or above)\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit\n* Aphakia or absence of the posterior capsule\n* Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of yttrium-aluminum garnet (YAG) laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation.\n* Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia\n* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery in the study eye\n* Intraocular surgery (including cataract surgery) within 3 months preceding the enrollment visit\n* Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n* History of prior vitrectomy surgery and absence of posterior capsule\n\nEither Eye\n\n* History of idiopathic or autoimmune-associated uveitis\n* Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis\n\nConcurrent Systemic Conditions\n\n* Inability to comply with study schedule or procedures as described in the study protocol\n* Uncontrolled blood pressure\n* History of stroke within the last 3 months prior to informed consent\n* Uncontrolled atrial fibrillation within 3 months of informed consent\n* History of myocardial infarction within the last 3 months prior to informed consent\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study or renders the patient at high risk of treatment complications in the opinion of the investigator\n* Current systemic treatment for a confirmed active systemic infection\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment\n* Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month preceding the informed consent (excluding vitamins and minerals)\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit\n* History of albinism\n* Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last ITV injection of ranibizumab or 1 year after the last implant refill-exchange of ranibizumab\n\nSub-study 2\n\nInclusion Criteria:\n\n* Having experienced septum dislodgement in the original implant while in the main study or after exiting the main study Ocular Inclusion Criteria for Study Eye\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center\n\nExclusion Criteria (Cohort 1 only):\n\nConcurrent Ocular Conditions-Study Eye\n\n* Any ocular condition that may render the patient at high risk for surgical or treatment complications\n* Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit\n* Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment\n* History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit\n* Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss\n* Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant\n* Ongoing ocular complications that might affect participant safety\n\nConcurrent Ocular Conditions-Either Eye\n\n* Suspected or active ocular or periocular infection\n* Any history of uveitis\n* Active blepharitis\n\nConcurrent Systemic Conditions\n\n* Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications\n* Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer\n* Current systemic treatment for a confirmed active systemic infection - Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in the main study GR40549) within 6 months prior to enrollment.\n* Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives.","locations":[{"facility":"Retinal Research Institute, LLC","city":"Phoenix","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Arizona Retina and Vitreous Consultants","city":"Phoenix","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Barnet Dulaney Perkins Eye Center","city":"Phoenix","state":"Arizona","country":"United 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Servicio de Oftalmologia","city":"Córdoba","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinica Baviera","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitatsspital Basel Augenklinik Klinik","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inselspital Universitaetsklinik fuer Augenheilkunde;Marie-Colinet-Haus","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vista Klinik Ophthalmologische Klinik","city":"Binningen","state":"","country":"Switzerland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fondation Asile Des Aveugles ? Jules Gonin Eye Hospital","city":"Lausanne","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stadtspital Triemli Ophthalmologische Klinik","city":"Zurich","state":"","country":"Switzerland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital","city":"Changhua","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation - Linkou","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Zhongzheng Dist.","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe University Medical Faculty","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent City Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Etlik City Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beyoglu Goz Training and Research Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kocaeli University Medical Faculty","city":"Kocaeli","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bristol Eye Hospital","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Liverpool University Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Moorfields Eye Hospital NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Central Middlesex Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kings College Hospital NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Royal Victoria Infirmary","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sunderland Eye Infirmary","city":"Sunderland","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Royal Wolverhampton hospital","city":"Wolverhampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: GR40549 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Incidence and Severity of Ocular and Systemic (Non-Ocular) Adverse Events (AEs)","Incidence, Severity, and Duration of Adverse Event of Special Interest (AESIs)","Incidence, Severity, and Duration of PDS-Associated Ocular AESIs During the Postoperative Period (Up to 37 days of Initial Implantation) and Follow-Up Period (>37 days After Implantation Surgery) for Participants who Receive the PDS Implant in the Study","Incidence and Severity of Adverse Device Effects","Incidence, Causality, Severity, And Duration Of Anticipated Serious Adverse Device Effects","Sub-study 1: Rate of Vitreous Hemorrhage Secondary to Choroidal Bleeding That Does not Resolve by the Week 4 Visit After Implant Insertion Surgery.","Sub-study 2: Number of Participants with Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of These AEs","Sub-study 2: Number of Participants with Adverse Events of Special Interests (AESIs) and Severity of AESIs","Sub-study 2: Duration of AESIs","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period","Sub-study 2: Number of participants with Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period","Sub-study 2: Duration of Ocular AESIs During the Post-operative Period","Sub-study 2: Duration of Ocular AESIs During the Follow-up Period","Sub-study 2: Number of Participants with Adverse Device Effects (ADEs) and Severity of ADEs","Sub-study 2: Number of Participants with Anticipated Serious ADEs and Severity of Anticipated Serious ADEs","Sub-study 2: Duration of Anticipated Serious ADEs","Sub-study 2: Number of Device Deficiencies"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","bakersfield-california","beverly-hills-california","encino-california","la-jolla-california","los-angeles-california","mountain-view-california","poway-california","sacramento-california","san-francisco-california","santa-ana-california","santa-barbara-california","durango-colorado","fort-collins-colorado","lakewood-colorado","waterford-connecticut","boynton-beach-florida","fort-myers-florida","melbourne-florida","palm-beach-gardens-florida","pensacola-florida","plantation-florida","st-petersburg-florida","tallahassee-florida","tampa-florida","augusta-georgia","marietta-georgia","joliet-illinois","oak-forest-illinois","west-des-moines-iowa","lenexa-kansas","lexington-kentucky","paducah-kentucky","portland-maine","baltimore-maryland","chevy-chase-maryland","towson-maryland","boston-massachusetts","grand-rapids-michigan","royal-oak-michigan","minneapolis-minnesota","chesterfield-missouri","st-louis-missouri","reno-nevada","bloomfield-new-jersey","teaneck-new-jersey","albuquerque-new-mexico","great-neck-new-york","rochester-new-york","rockville-centre-new-york","syracuse-new-york","charlotte-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","edmond-oklahoma","portland-oregon","philadelphia-pennsylvania","florence-south-carolina","west-columbia-south-carolina","germantown-tennessee","nashville-tennessee","arlington-texas","austin-texas","bellaire-texas","fort-worth-texas","san-antonio-texas","the-woodlands-texas","salt-lake-city-utah","virginia-beach-virginia","silverdale-washington","spokane-washington","capital-federal-argentina","ciudad-autonoma-buenos-aires-argentina","rosario-argentina","albury-australia","hurstville-australia","graz-austria","vienna-austria","leuven-belgium","blumenau-brazil","s-o-paulo-brazil","sorocaba-brazil","bordeaux-france","lyon-france","marseille-france","paris-france","bonn-germany","cologne-germany","cottbus-germany","freiburg-im-breisgau-germany","hamburg-germany","ludwigshafen-germany","m-nchen-germany","m-nster-germany","sulzbach-germany","t-bingen-germany","ulm-germany","haifa-israel","jerusalem-israel","kfar-saba-israel","petah-tikva-israel","rehovot-israel","tel-aviv-israel","chieti-italy","bari-italy","trieste-italy","rome-italy","milan-italy","torrette-ancona-italy","florence-italy","perugia-italy","negrar-verona-italy","udine-italy","lhospitalet-de-llobregat-spain","san-cugat-del-valles-spain","majadahonda-spain","pamplona-spain","oviedo-spain","burjassot-spain","barcelona-spain","c-rdoba-spain","madrid-spain","basel-switzerland","bern-switzerland","binningen-switzerland","lausanne-switzerland","zurich-switzerland","changhua-taiwan","kaohsiung-city-taiwan","taipei-taiwan","taoyuan-taiwan","zhongzheng-dist-taiwan","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","kocaeli-turkey-t-rkiye","bristol-united-kingdom","liverpool-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","sunderland-united-kingdom","wolverhampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing PDS Implant with Ranibizumab 100 mg/mL for Neovascular Age-Related Macular Degeneration","inPlainEnglish":"This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.","whoItsFor":["Ages 50 Years to any","Ability and willingness to undertake all scheduled visits and assessments","For women of childbearing potential: agreement to remain abstinent or use contraceptive measures"],"whoShouldSkip":["Pregnant or breastfeeding, or intending to become pregnant during the treatment period and for at least 28 days after the last intravitreal injection of ranibizumab or 1 year after the last Implant refill-exchange of ranibizumab","History of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab, that might affect interpretation of the results of the study or that renders the participant at high risk for treatment complications","Requirement for continuous use of any medications or treatments indicated in the \"Prohibited Therapy\"","\\- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures","Participants must meet the following ocular criteria for the study eye for substudy entry:","Diagnosis of exudative nAMD within 2 years prior to the enrollment visit","Previous treatment with at least two anti-VEGF ITV injections (e.g., ranibizumab, bevacizumab, or aflibercept) for nAMD per standard of care within 6 months prior to the enrollment visit"],"whatHappens":"If you join, the listed intervention(s) are PDS Implant with Ranibizumab 100 mg/mL. The registry lists allocation as randomized. This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 165 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.148Z"},{"nctId":"NCT03685721","title":"Genotype -Phenotype Correlation of PKLR Variants With Pyruvate Kinase, 2,3-Diphosphglycerate and Adenosine Triphosphate Activities in Red Blood Cells of People With Sickle Cell Disease","officialTitle":"Genotype -Phenotype Correlation of PKLR Variants With Pyruvate Kinase, 2,3-Diphosphglycerate and ATP Activities in Red Blood Cells of Patients With Sickle Cell Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nSome people with the same disorder on a genetic level have more complications than others. Researchers want to look for a link between the PKLR gene and sickle cell disease (SCD) symptoms. The PKLR gene helps create a protein, called pyruvate kinase that is essential in normal functioning of the red blood cell. Differences in the PKLR gene, called genetic variants, may cause some changes in the pyruvate kinase protein and other proteins, that can affect functioning of the red blood cell adding to the effect of SCD. Researchers can study these differences by looking at DNA (the material that determines inherited characteristics).\n\nObjective:\n\nTo study how the PKLR gene affects sickle cell disease.\n\nEligibility:\n\nAdults ages 18-80 of African descent. They may have sickle cell disease or not. They must not have had a transfusion recently or have a known deficiency of pyruvate kinase. They cannot be pregnant.\n\nDesign:\n\nParticipants will be screened with questions.\n\nParticipants will have blood drawn by needle in an arm vein. The blood will be genetically tested. Not much is known about how genes affect SCD, so the test results will not be shared with participants or their doctors.\n\n...","conditions":["Sickle Cell","PKLR Variants","Adenosine Triphosphate Activities"],"keywords":["ATP","Trait","GDP","Genetics","Natural History"],"interventions":[],"enrollment":800,"startDate":"2018-10-11","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSUION CRITERIA:\n* Between 18 and 80 years of age\n* African or of African descent\n* Capacity to consent is required\n\nEXCLUSION CRITERIA:\n\n* Self-reported history of blood transfusion within the last 8 weeks\n* Known to have pyruvate kinase deficiency and be on AG348\n* All volunteers will undergo the consent process under this protocol to allow for eligibility assessment. Once they have been consented to participate, they will undergo procedures per Protocol.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dianna S Lovins","phone":"(301) 480-3765","email":"dianna.lovins@nih.gov"}],"primaryOutcomes":["Genotype the 4 PKLR intron-2 variants","Analysis of PK-R transcriptome in red blood cells","Correlation of 2,3-DPG, ATP and pyruvate kinase activities with PKLR intron-2 variants"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Genotype -Phenotype Correlation of PKLR Variants With Pyruvate Kinase, 2,3-Diphosphglycerate and Adenosine …","inPlainEnglish":"Background: Some people with the same disorder on a genetic level have more complications than others. Researchers want to look for a link between the PKLR gene and sickle cell disease (SCD) symptoms.","whoItsFor":["Ages 18 Years to 80 Years","INCLUSUION CRITERIA:","Between 18 and 80 years of age","African or of African descent","Capacity to consent is required"],"whoShouldSkip":["Self-reported history of blood transfusion within the last 8 weeks","Known to have pyruvate kinase deficiency and be on AG348","All volunteers will undergo the consent process under this protocol to allow for eligibility assessment. Once they have been consented to participate, they will undergo procedures per Protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 800 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.831Z"},{"nctId":"NCT03723928","title":"S1703 Serum Tumor Marker Directed Disease Monitoring in Patients With Hormone Receptor Positive Her2 Negative Metastatic Breast Cancer","officialTitle":"Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored With Serum Tumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients With Metastatic Hormone Receptor Positive Breast Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"SWOG Cancer Research Network","sponsorClass":"NETWORK","summary":"This randomized research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Estrogen Receptor Positive","HER2/Neu Negative","Progesterone Receptor Positive","Prognostic Stage IV Breast Cancer AJCC v8","Elevated CA15-3 or CEA or CA27-29"],"keywords":[],"interventions":[{"type":"OTHER","name":"Usual care disease monitoring"},{"type":"OTHER","name":"Serum Tumor Marker directed disease monitoring"},{"type":"OTHER","name":"Quality-of-Life Assessment"},{"type":"OTHER","name":"Anxiety Questionnaire Administration"}],"enrollment":739,"startDate":"2018-09-17","completionDate":"2030-01-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1 REGISTRATION\n* Patients must have a diagnosis of hormone receptor positive (estrogen receptor positive \\[ER+\\] and/or progesterone receptor positive \\[PR+\\]), HER-2 negative, metastatic (M1) breast cancer and must be receiving or plan to receive first-line systemic treatment for metastatic disease. (Systemic treatment is any treatment meant to treat the whole body such as endocrine therapy +/- targeted therapy +/- chemotherapy).\n\n  * NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic\n* Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease\n* Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (at least one of these must be tested)\n  * At least one of the tested STMs must have been \\>= 1.5 x the institutional upper limit of normal at this time.\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* Patients must have systemic radiographic imaging prior to initiation of systemic therapy or within 30 days of initiation of treatment for metastatic breast cancer and prior to step 1 registration. Modality of imaging is at the discretion of the treating physician.\n\n  * Note: the treating physician can order additional imaging tests at any point prior to randomization at their discretion\n* Patients must be willing to obtain disease monitoring (imaging and/or serum tumor markers) from a consistent facility in which the registering site has access to the results for the duration of the study intervention (312 weeks after step 2 randomization). Imaging and STMs do not need to be completed at the same facility.\n* Patients with known cirrhosis, untreated B12 deficiency, thalassemia, or sickle cell anemia are not eligible as these could cause falsely elevated STM levels\n* Patients with known brain leptomeningeal metastases are not eligible as they may require regular radiographic monitoring to assess treatment response\n* Patients must not be currently enrolled or plan to participate in a first-line treatment trial for metastatic breast cancer with a defined monitoring schedule\n* Patients who are able to complete questionnaires in English or Spanish must participate in patient-reported outcome (PRO) assessments\n* Patients must not be pregnant due to the potential harm to the fetus from radiation exposure from radiographic imaging\n* Except for breast cancer (and previous history of breast cancer), no other prior malignancy is allowed with the following exceptions:\n\n  * Adequately treated basal (or squamous cell) skin cancer\n  * Any cancer from which the patient has been disease free for five years\n  * Prior Stage 0 or pre-cancerous lesions that have been removed with clear margins\n* Patients must not have received prior systemic therapy for metastatic breast cancer, except for their current line of therapy.\n* Patients must have decision making capacity and be able to provide informed consent\n* Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines; use of legally-authorized representative is not permissible for this study. Remote consent is allowed with adequate documentation.\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2 RANDOMIZATION\n* Patients must be tested for the breast cancer specific STMs that were tested prior to STEP 1 Registration between 56 and 140 days after initiation of first-line systemic therapy for metastatic disease:\n\n  * CEA (must be tested)\n  * CA 15-3 or CA 27.29 (whichever was tested prior to Step 1)\n\nTesting all three STMs is encouraged but only two are required. Patients must plan to have the same two STMs tested for the duration that the patient is on protocol-specified disease monitoring.\n\n* At least one of the STMs that was previously elevated must have decreased from the assessment at step 1 by \\>= 10% at this time.\n* Patients must not have known progression since registration to step 1\n* Patients must be registered to step 2 randomization between 56 days and 140 days after the initiation of first-line systemic therapy for metastatic disease; This window is inclusive; patients may be registered to Step 2 on day 56 or Day 140. Patients must have been eligible for Step 1 in order to be eligible for Step 2 Randomization\n* Baseline questionnaires must be completed within 28 days prior to step 2 randomization; (Note: Those patients who cannot complete the PRO questionnaires in English or Spanish can be registered to step 2 without contributing to PRO research)","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Oncology Centre","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairbanks Memorial Hospital","city":"Fairbanks","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kingman Regional Medical Center","city":"Kingman","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint 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a traditional drug phase: Usual care disease monitoring for Anatomic Stage IV Breast Cancer AJCC v8","inPlainEnglish":"This randomly assigned research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body. Using markers to prompt when scans should be ordered may be as good as the usual approach to monitoring disease.","whoItsFor":["Ages 18 Years to any","STEP 1 REGISTRATION","NOTE: Participants are eligible if they have either de-novo metastatic breast cancer and/or recurrent breast cancer from an earlier stage that is now metastatic","Patients must be registered to step 1 between 14 days prior to and 60 days after start of first-line systemic treatment for metastatic disease","Patients must have been tested for the following breast cancer specific STMs after diagnosis of metastatic disease and within +/-14 days of initiation of first-line systemic treatment for metastatic disease:","CEA (must be tested)","CA 15-3 or CA 27.29 (at least one of these must be tested)","At least one of the tested STMs must have been \\>= 1.5 x the institutional upper limit of normal at this time"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Usual care disease monitoring, Serum Tumor Marker directed disease monitoring, or Quality-of-Life Assessment. The registry lists allocation as randomized. This randomly assigned research trial studies how well serum tumor marker directed disease monitoring works in monitoring patients with hormone receptor positive Her2 negative breast cancer that has spread to other places in the body.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 739 people at 723 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.986Z"},{"nctId":"NCT03799354","title":"Study on Impact of Maximal Strength Training in Patients With COPD","officialTitle":"Study on Impact of Maximal Strength Training in Patients With COPD: Physiological and Clinical Implications","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of adverse events.\n\nMaximal Strength Training (MST) is a kind of RT typically performed at \\~85-90% of 1RM with maximal velocity to be developed in the concentric phase. Recent literature indicates a significant amelioration on the Rate of Force Development (RFD) after MST in healthy subjects, post-menopausal woman and older populations.\n\nWhen comparing to the conventional ET, MST generates a little change in muscle mass (no hypertrophy), but a much greater improvement in the RFD. It has been described that neural adjustments play a major role in the MST-induced adaptations. MST is also well documented to improve aerobic endurance by improving walking work efficiency.\n\nOnly a small cohort study of COPD patients was conducted, describing that MST can meaningfully improve strength and RFD, with an increase of around 32% for mechanical efficiency and a decrease of the perceived effort during submaximal job. This improvement could determine best performances in daily activities and a best quality of life. The main aims of this physiological pilot randomized controlled trail will be to evaluate feasibility and efficacy of the MST compared to standard ET on strength, effort tolerance, fatigue, economy of walking, dyspnea and risk of falls in a populations of COPD patients, in a short and middle term (6 months).","conditions":["Chronic Obstructive Pulmonary Disease"],"keywords":["rehabilitation","resistive training","exercise"],"interventions":[{"type":"OTHER","name":"Maximal strenght training (MST) plus endurance training (ET)"},{"type":"OTHER","name":"Endurance training (ET)"}],"enrollment":20,"startDate":"2019-09-18","completionDate":"2027-02-28","sex":"ALL","minAge":"50 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) \\< 70%, and FEV1 \\< 50% of predicted\n* stable clinical condition\n\nExclusion Criteria:\n\n* pulmonary diseases other than COPD\n* type II diabetes or other metabolic diseases\n* malign disease\n* a respiratory tract infection within the last 4 wks\n* long oxygen therapy use.","locations":[{"facility":"ICS Maugeri IRCCS, Respiratory Rehabilitation of the Institute of Lumezzane","city":"Lumezzane","state":"Brescia","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mara Paneroni, MSc, PT","phone":"0039+030+8253","email":"mara.paneroni@icsmaugeri.it"},{"name":"Paola Baiardi, Math","phone":"0039+0382+592","email":"paola.baiardi@icsmaugeri.it"}],"primaryOutcomes":["Change in walking efficiency"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["lumezzane-italy"],"enrichment":{"headline":"Not a traditional drug phase: Maximal strenght training (MST) plus endurance training (ET) for Chronic Obstructive Pulmonary Disease","inPlainEnglish":"In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of side effects. Maximal Strength Training (MST) is a kind of RT typically performed at \\~85-90% of 1RM with maximal velocity to be developed in the concentric phase.","whoItsFor":["Ages 50 Years to 80 Years","COPD clinical definition according to GOLD guidelines with forced expiratory volume (FEV1)/ forced vital capacity (FVC) \\< 70%, and FEV1 \\< 50% of predicted","stable clinical condition"],"whoShouldSkip":["pulmonary diseases other than COPD","type II diabetes or other metabolic diseases","a respiratory tract infection within the last 4 wks","long oxygen therapy use"],"whatHappens":"If you join, the listed intervention(s) are Maximal strenght training (MST) plus endurance training (ET), or Endurance training (ET). The registry lists allocation as randomized. In the context of pulmonary rehabilitation of COPD patients, recent guidelines and metanalysis describe that Resistance Training (RT) can be successfully performed alone or in conjunction with Endurance Training (ET) without evidence of side effects.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Lumezzane. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.658Z"},{"nctId":"NCT03819608","title":"Neuromodulation and Neurorehabilitation for mTBI","officialTitle":"Neuromodulation and Neurorehabilitation for Treatment of Functional Deficits After mTBI and PTSD","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"TRIPLE","sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.","conditions":["Mild Traumatic Brain Injury","Post Traumatic Stress Disorder"],"keywords":["mTBI","PTSD","intermittent theta burst stimulation","cognitive training","neuroimaging"],"interventions":[{"type":"DEVICE","name":"real iTBS"},{"type":"BEHAVIORAL","name":"real APT"},{"type":"BEHAVIORAL","name":"placebo APT"},{"type":"DEVICE","name":"placebo iTBS"}],"enrollment":200,"startDate":"2021-04-01","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* At least 18 years of age and no older than 80 years of age\n* 3 months post exposure to mTBI event\n* Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID\n* Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory\n\nExclusion Criteria:\n\n* Participating in another research study\n* Non-fluent in English (speaking and reading)\n* History of epilepsy pre-injury\n* Receiving antiepileptic treatment for documented active seizures in the past 6 months\n* Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol\n* History of surgery on blood vessels in brain and/or valves of the heart\n* History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders\n* History or current diagnosis of psychotic spectrum disorders (i.e. bipolar, schizophrenia)\n* Significant heart disease as determined by physician review of medical chart\n* Pregnant at time of enrollment or any time during study participation\n* MRI or TMS/iTBS contraindications such as claustrophobia, metal in eyes/face or brain\n* Cardiac pacemakers/defibrillators, cochlear implants, nerve stimulators, intracranial metal clips\n* Diagnosis of moderate or severe TBI (loss of consciousness \\> 30 minutes, alteration of consciousness \\> 24 hours, post traumatic amnesia or neuropsychological testing results\n* Prescribed dosage of mental health medications have been altered within the month preceding study screening. Any participant whose mental health medication(s) has/have changed, within 30 days of study screening. The following are considered a medication change: the addition of or discontinuation of medication, a change in the dose or dosage (daily amount) of medication.\n* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation\n* Taking prescribed CNS stimulants and choosing to not stop these medications during study participation\n* Testing positive for opiates and do not have a prescription for opiates. If on prescription opiates and taking more than the equivalent of 200 mg of morphine per day.\n* Questionably valid test performance as indicated by a score of ≤ 85% on the Immediate Recognition, Delayed Recognition or Consistency Scales of the Medical Symptom Validity Test (MSVT) and clinical determination of questionable performance validity by a neuropsychologist on the research team\n* Actively suicidal as evidenced by plan to harm or recent attempt communicated on the Structured Clinical Interview for DSM-V (SCID-5).\n* Increased Intracranial Pressure (ICP) as evidenced through a funduscopic evaluation or on the baseline MRI scan.\n* Moderate or severe cannabis use disorder defined by ≥ 4 symptoms on the SCID-5\n* Severe alcohol use disorder defined by ≥ 6 symptoms on the SCID-5\n* Baseline systolic BP greater or equal to 170","locations":[{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moody Neurorehabilitation Institute","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Catherine M Kestner","phone":"708-878-0578","email":"ckestner@sralab.org"}],"primaryOutcomes":["Change in the Mayo Portland Adaptability Inventory (MPAI)"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["chicago-illinois","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: real iTBS for Mild Traumatic Brain Injury","inPlainEnglish":"This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.","whoItsFor":["Ages 18 Years to 80 Years","At least 18 years of age and no older than 80 years of age","3 months post exposure to mTBI event","Have a history of mTBI with PTSD OR mTBI without PTSD as defined by formalized measures to classify mTBI based on the Symptom Attribution and Classification Algorithm (SACA) and the PTSD Module L of the SCID","Endorse at least moderate severity on at least one of the four cognitive complaints in the Neurobehavioral Symptom Inventory"],"whoShouldSkip":["Participating in another research study","Non-fluent in English (speaking and reading)","History of epilepsy pre-injury","Receiving antiepileptic treatment for documented active seizures in the past 6 months","Taking medications that lower seizure threshold including antipsychotics, trazodone and tramadol","History of surgery on blood vessels in brain and/or valves of the heart","History of brain hemorrhage, neurovascular conditions and neurodegenerative disorders"],"whatHappens":"If you join, the listed intervention(s) are real iTBS, real APT, or placebo APT. The registry lists allocation as randomized. This study will determine (i) the magnitude of immediate and sustained effects of a current clinical standard interactive computer attention processing training (APT) when combined with intermittent theta burst stimulation (iTBS), a type of repetitive transcranial magnetic stimulation and (ii) determine how APT + iTBS changes the neurocognitive system of attention in individuals with persistent attention deficits related to mTBI +/- PTSD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.417Z"},{"nctId":"NCT03829787","title":"Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder","officialTitle":"Attentional Biases, Reward Sensitivity, and Cognitive Control in Adults With Bipolar Disorder and Different Psychiatric Comorbidities: An Eye-Tracking Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospitals Cleveland Medical Center","sponsorClass":"OTHER","summary":"The purpose of this study is to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.","conditions":["Bipolar Disorder"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Eye tracking"}],"enrollment":100,"startDate":"2019-03-27","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"1. Inclusion and Exclusion Criteria for Group 1: bipolar disorder without current anxiety or substance use disorder\n\n   1. Inclusion Criteria for Group 1:\n\n   i. Male or female, age 18 or older\n\n   ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to Diagnostic and Statistical Manual-5 (DSM-5) criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   iii. Currently in a depressive episode or currently in remission from a mood episode\n\n   iv. Young Mania Rating Scale total score ≤ 8\n\n   v. In the opinion of the investigator, capable of understanding and complying with protocol requirements\n\n   vi. In the opinion of the investigator, has the competency to understand and sign the informed consent\n\n   vii. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion\n\n   b. Exclusion Criteria for Group 1:\n\n   i. Significant structural brain lesion (e.g. infarct, hemorrhage, tumor, multiple sclerosis)\n\n   ii. Progressive neurological disease such as neurodegenerative disease\n\n   iii. Any current psychiatric disorder (other than a current depressive episode) including anxiety disorders, substance use disorders, antisocial personality disorder and borderline personality disorder as assessed by the MINI and clinician assessment.\n\n   iv. Currently pregnant or planning to become pregnant\n\n   v. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription\n\n   vi. Currently taking any steroids, stimulants, or opioid pain killers.\n\n   vii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine.Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.\n\n   viii. Has had electroconvulsive therapy (ECT) treatment within the last 6 months.\n2. Inclusion and Exclusion Criteria for Group 2: Bipolar disorder with a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia)\n\n   a. Inclusion Criteria for Group 2:\n\n   i. Male or female, age 18 or older\n\n   ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   iii. Currently in a depressive episode or currently in remission from a mood episode\n\n   iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   v. Hamilton Anxiety Rating Scale total score ≥ 18\n\n   vi. Young Mania Rating Scale total score ≤ 8\n\n   vii. In the opinion of the investigator, capable of understanding and complying with protocol requirements\n\n   viii. In the opinion of the investigator, has the competency to understand and sign the informed consent\n\n   ix. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion\n\n   b. Exclusion Criteria for Group 2:\n\n   i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)\n\n   ii. Progressive neurological disease such as neurodegenerative disease\n\n   iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD)\n\n   iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.\n\n   v. Currently pregnant or planning to become pregnant\n\n   vi. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription\n\n   vii. Currently taking any steroids, stimulants, or opioid pain killers.\n\n   viii. Meets DSM-5 criteria for any alcohol and/or drug use disorder within the last 6 months, excluding the use of caffeine\n\n   ix. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.\n\n   x. Has had ECT treatment within the last 6 months.\n3. Inclusion and Exclusion Criteria for Group 3: Bipolar disorder with a current anxiety disorder and a current substance use disorder\n\n   a. Inclusion Criteria for Group 3:\n\n   i. Male or female, age 18 or older\n\n   ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   iii. Meets diagnostic criteria for a substance use disorder within the last 3 months\n\n   iv. Meets diagnostic criteria for a current anxiety disorder (generalized anxiety disorder, panic disorder, and/or social phobia) as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   v. Currently in a depressive episode or currently in remission from a mood episode\n\n   vi. Hamilton Anxiety Rating Scale total score ≥ 18\n\n   vii. Young Mania Rating Scale total score ≤ 8\n\n   viii. In the opinion of the investigator, capable of understanding and complying with protocol requirements\n\n   ix. In the opinion of the investigator, has the competency to understand and sign the informed consent\n\n   x. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion\n\n   b. Exclusion Criteria for Group 3:\n\n   i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)\n\n   ii. Progressive neurological disease such as neurodegenerative disease\n\n   iii. Any co-occurring lifetime or current obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), or attention deficit hyperactivity disorder (ADHD)\n\n   iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.\n\n   v. Intoxicated or in acute withdrawal state.\n\n   vi. Currently pregnant or planning to become pregnant.\n\n   vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.\n\n   viii. Has had ECT treatment within the last 6 months.\n4. Inclusion and Exclusion Criteria for Group 4: Bipolar disorder without an anxiety disorder but with a current substance use disorder\n\n   a. Inclusion Criteria for Group 4:\n\n   i. Male or female, age 18 or older\n\n   ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to the DSM-5 criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   iii. Meets diagnostic criteria for a substance use disorder within the last 3 months\n\n   iv. Currently in a depressive episode or currently in remission from a mood episode\n\n   v. Young Mania Rating Scale total score ≤ 8\n\n   vi. Hamilton Anxiety Rating Scale total score ≤ 12\n\n   vii. In the opinion of the investigator, capable of understanding and complying with protocol requirements\n\n   viii. In the opinion of the investigator, has the competency to understand and sign the informed consent\n\n   ix. Subject is compliant with taking psychiatric medication(s) per the investigator's discretion\n\n   b. Exclusion Criteria for Group 4:\n\n   i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)\n\n   ii. Progressive neurological disease such as neurodegenerative disease\n\n   iii. Any co-occurring current anxiety disorder or attention deficit hyperactivity disorder (ADHD)\n\n   iv. Meets criteria for antisocial personality disorder or borderline personality disorder as assessed by clinician assessment.\n\n   v. Intoxicated or in an acute withdrawal state\n\n   vi. Currently pregnant or planning to become pregnant.\n\n   vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.\n\n   viii. Has had ECT treatment within the last 6 months.\n5. Inclusion and exclusion criteria for Group 5: Healthy Volunteers\n\n   1. Inclusion criteria for Group 5:\n\n   i. Male or female, age 18 or older\n\n   ii. In the opinion of the investigator, capable of understanding and complying with protocol requirements\n\n   iii. In the opinion of the investigator, has the competency to understand and sign the informed consent\n\n   iv. Physically healthy as determined by research psychiatrist\n\n   v. Without any current and/or lifetime psychiatric disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI)\n\n   b. Exclusion Criteria for Group 5:\n\n   i. Significant structural brain lesion identified (e.g. infarct, hemorrhage, tumor, multiple sclerosis)\n\n   ii. Progressive neurological disease such as neurodegenerative disease\n\n   iii. Any psychiatric disorder including any severe personality disorder\n\n   iv. Currently pregnant or planning to become pregnant\n\n   v. Tests positive for illegal substances or prescription medications for which they do not have a valid prescription\n\n   vi. Currently taking any steroids, stimulants, or opioid pain killers.\n\n   vii. Currently experiencing nicotine use disorder or any smoking of cigarettes or use of other nicotine containing products within a week before the eye tracking visit.","locations":[{"facility":"University Hospitals Cleveland Medical Center - Mood Disorders Program","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicole Jones","phone":"216/844-2862","email":"mdp@uhhospitals.org"}],"primaryOutcomes":["Measure the differences in attentional bias among the 5 groups by assessing how long it takes a subject to locate and fixate on each face on the screen","Measure the differences in reward sensitivity among the 5 groups by assessing the amplitude of the saccade to reward and non-reward stimuli","Measure the differences in reward sensitivity among the 5 groups by assessing the velocity of the saccade to reward and non-reward stimuli","Measure the differences in cognitive control among the 5 groups by assessing the amplitude of the antisaccade","Measure the differences in cognitive control among the 5 groups by assessing the velocity of the antisaccade"],"hasResults":false,"conditionSlugs":["bipolar-disorder"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Eye tracking for Bipolar Disorder","inPlainEnglish":"This study wants to use eye-tracking technology to study attentional biases, reward sensitivity, and cognitive control in adult patients with bipolar disorder with or without anxiety and/or substance use disorder comorbidity.","whoItsFor":["Ages 18 Years to any"],"whoShouldSkip":["for Group 1: bipolar disorder without current anxiety or substance use disorder","who can join for Group 1:","i. Male or female, age 18 or older","ii. Meets diagnostic criteria for lifetime bipolar I or II disorder according to Diagnostic and Statistical Manual-5 (DSM-5) criteria, as confirmed by the Mini International Neuropsychiatric Interview (MINI)","iii. Currently in a depressive episode or currently in remission from a mood episode","iv. Young Mania Rating Scale total score ≤ 8","v. In the opinion of the investigator, capable of understanding and complying with protocol requirements"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Cleveland. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.743Z"},{"nctId":"NCT03830801","title":"Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus","officialTitle":"Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.","conditions":["Barrett Esophagus"],"keywords":["Barrett's Esophagus","EGD","Endoscopy","Biopsy","Tethered Capsule Endomicroscopy","OCT"],"interventions":[{"type":"DEVICE","name":"IVLCM tethered capsule"}],"enrollment":30,"startDate":"2017-12-06","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have a current or prior diagnosis of Barrett's Esophagus\n* Participants must be over the age of 18.\n* Participants must be able to give informed consent.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure.\n* Participants with a history of hemostasis disorders.\n* Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule.\n* Participants with a know history of esophageal varices\n* Participants above 80 years of age","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anita Chung, RN","phone":"617-724-4515","email":"Tearneylabtrials@partners.org"},{"name":"Camila Salcedo, CRC","phone":"617-724-4515","email":"Tearneylabtrials@partners.org"}],"primaryOutcomes":["The number of participants from which we will be able to collect biopsy samples using IVLCM technique"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: IVLCM tethered capsule for Barrett Esophagus","inPlainEnglish":"The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed.","whoItsFor":["Ages 18 Years to any","Participants must have a current or prior diagnosis of Barrett's Esophagus","Participants must be over the age of 18"],"whoShouldSkip":["Participants who are on anti-platelet medications or anti-coagulation medications, and NSAIDS at the time of procedure","Participants with a history of hemostasis disorders","Participants with esophageal strictures, resulting in a luminal diameter smaller than the diameter of the capsule","Participants with a know history of esophageal varices","Participants above 80 years of age"],"whatHappens":"If you join, the listed intervention(s) are IVLCM tethered capsule. The registry lists allocation as na. The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Boston. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.449Z"},{"nctId":"NCT03866382","title":"Testing the Effectiveness of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) With One Anti-cancer Targeted Drug (Cabozantinib) for Rare Genitourinary Tumors","officialTitle":"A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.","conditions":["Bladder Adenocarcinoma","Bladder Clear Cell Adenocarcinoma","Bladder Mixed Adenocarcinoma","Bladder Neuroendocrine Carcinoma","Bladder Small Cell Neuroendocrine Carcinoma","Bladder Squamous Cell Carcinoma","Chromophobe Renal Cell Carcinoma","Collecting Duct Carcinoma","Invasive Bladder Giant Cell Urothelial Carcinoma","Invasive Bladder Lymphoepithelioma-Like Carcinoma","Invasive Bladder Nested Urothelial Carcinoma","Invasive Bladder Plasmacytoid Urothelial Carcinoma","Invasive Bladder Sarcomatoid Urothelial Carcinoma","Invasive Bladder Urothelial Carcinoma","Kidney Medullary Carcinoma","Large Cell Neuroendocrine Carcinoma","Malignant Testicular Leydig Cell Tumor","Malignant Testicular Sertoli Cell Tumor","Metastatic Bladder Carcinoma","Metastatic Bladder Clear Cell (Glycogen-Rich) Urothelial Carcinoma","Metastatic Bladder Giant Cell Urothelial Carcinoma","Metastatic Bladder Large Cell Neuroendocrine Carcinoma","Metastatic Bladder Lipid-Rich Urothelial Carcinoma","Metastatic Bladder Micropapillary Urothelial Carcinoma","Metastatic Bladder Plasmacytoid Urothelial Carcinoma","Metastatic Bladder Sarcomatoid Urothelial Carcinoma","Metastatic Bladder Small Cell Neuroendocrine Carcinoma","Metastatic Bladder Squamous Cell Carcinoma","Metastatic Chromophobe Renal Cell Carcinoma","Metastatic Kidney Medullary Carcinoma","Metastatic Malignant Genitourinary System Neoplasm","Metastatic Papillary Renal Cell Carcinoma","Metastatic Penile Carcinoma","Metastatic Prostate Small Cell Neuroendocrine Carcinoma","Metastatic Sarcomatoid Renal Cell Carcinoma","Metastatic Urethral Carcinoma","Papillary Renal Cell Carcinoma","Sarcomatoid Renal Cell Carcinoma","Stage IV Bladder Cancer AJCC v8","Stage IV Penile Cancer AJCC v8","Stage IV Renal Cell Cancer AJCC v8","Stage IV Urethral Cancer AJCC v8","Stage IVB Prostate Cancer AJCC v8","Urachal Adenocarcinoma","Urethral Clear Cell Adenocarcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Scan"},{"type":"DRUG","name":"Cabozantinib S-malate"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"BIOLOGICAL","name":"Ipilimumab"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"}],"enrollment":314,"startDate":"2019-05-13","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:\n\n  * One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1\n  * One bone lesion on bone scan (tec99 or sodium fluoride \\[NaF\\] PET/CT, CT or MRI) for the bone-only cohort.\n  * Histologically confirmed diagnosis of one of the following metastatic cohorts:\n\n    * Small cell/ neuroendocrine carcinoma of the bladder (Cohort A)- All urothelial carcinomas with any amount of neuroendocrine differentiation (including small cell differentiation) will be included. If the tumor is purely neuroendocrine, metastasis from another site of origin should be clinically excluded\n    * Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \\[WHO\\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma\n    * Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)\n    * Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \\> or equal \\~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well)\n    * Any penile cancer (Cohort E)\n    * Sarcomatoid renal cell carcinoma (Cohort F) - Tumor should be predominantly sarcomatoid \\~ 50% (including rhabdoid differentiation) is also unclassified renal cell carcinomas (RCCs): all (assuming they are high grade with metastasis) malignant angiomyolipomas are allowed\n    * Other miscellaneous histologic variants of the urothelial carcinoma, such as, but not limited to (Cohort G) : Micropapillary (Tumor should show predominantly \\> or equal 50% micropapillary architecture), giant cell, lipid-rich, clear cell and nested variants (Tumor should predominantly \\> or equal 50% show these features), large cell neuroendocrine carcinoma, lymphoepithelioma-like carcinoma and mixed patterns will be considered, as well as small cell neuroendocrine prostate cancer (Only treatment-naïve primary small cell of prostate with any amount of small cell component allowed. Post-treatment small cell prostatic carcinomas are not allowed), Malignant testicular Sertoli or Leydig cell tumors, and papillary and chromophobe RCC\n\n      * Note: Translocation positive renal cell carcinoma patients are eligible. However, AREN1721 should be considered before this trial\n    * Sarcomatoid urothelial carcinoma (Cohort H) - Tumor should show predominantly \\~ 50% sarcomatoid differentiation\n    * Renal medullary carcinoma (Cohort I) - Per World Health Organization (WHO) definition, ideally confirmed with immunostains\n    * Bone-only metastatic GU tumors (non-prostate) (Cohort J) - All genitourinary histologies, except prostate are eligible\n    * Renal Collecting Duct Carcinoma (Cohort K) - Per WHO definition (medullary involvement, predominant tubular morphology, desmoplastic stromal reaction, high grade cytology, infiltrative growth pattern, and absence of other renal cell carcinoma subtype or urothelial carcinoma)\n    * Urethra carcinoma (Cohort L) - May be of any histology but if urothelial carcinoma then must be isolated to the urethra and not have metachronous or synchronous urothelial carcinoma of the bladder\n  * H\\&E slides from diagnostic tumor tissue for retrospective central pathology review\n* Patients may have received up to 2 systemic anti-cancer treatments or be treatment naive. Patients with small cell carcinoma should have received a platinum-based combination regimen either as neoadjuvant, adjuvant or first-line treatment). Patients in the bone-only cohort may be urothelial carcinoma histology but must receive standard cisplatin-based chemotherapy (if cisplatin-eligible)\n* Age \\>= 18 years\n* Patients must be able to swallow oral formulation of the tablets\n* Karnofsky performance status \\>= 80%\n* Absolute neutrophil count (ANC) \\>= 1,000/mcL\n* Platelet count \\>= 75,000/mcL\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN). For subjects with known Gilbert's disease or similar syndrome with slow conjugation of bilirubin, total bilirubin =\\< 3.0 mg/dL\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\\< 3.0 x institutional upper limit of normal (ULN) (or =\\< 5 x ULN for patients with liver metastases or Gilbert's disease)\n* Creatinine =\\< 1.5 x upper limit of normal (ULN) OR creatinine clearance \\>= 40 mL/min/1.73 m\\^2 (calculated using the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] equation or Cockcroft-Gault formula) for patients with creatinine levels above institutional normal\n* Hemoglobin \\>= 9 g/dL (transfusion of packed red blood cells \\[PRBCs\\] allowed)\n* Serum albumin \\>= 3.2 g/dL\n* Lipase and amylase =\\< 2.0 x ULN and no radiologic (on baseline anatomical imaging) or clinical evidence of pancreatitis\n* Prior treatment with MET or VEGFR inhibitors is allowed. However, prior cabozantinib will not be allowed. Also, patients that have received both prior MET or VEGF and prior PD-1/PD-L1/CTLA-4 (sequentially or in combination) are also not allowed\n* No prior treatment with any therapy on the PD-1/PD-L1 axis or anti- CTLA-4/CTLA-4 inhibitors with the exception of patients with \"urothelial carcinoma\" histology (cohorts D, H, J, L)\n* Human immunodeficiency virus (HIV)-positive patients are eligible if on stable dose of highly active antiretroviral therapy (HAART), no clinically significant drug-drug interactions are anticipated with the current HAART regimen, CD4 counts are greater than 350 and viral load is undetectable\n* Patients with rheumatoid arthritis and other rheumatologic arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication only and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies etc. are eligible but should be considered for rheumatologic evaluation for the presence of target organ involvement and potential need for systemic treatment\n* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones or medications (e.g. thyroiditis managed with propylthiouracil \\[PTU\\] or methimazole) including physiologic oral corticosteroids are eligible\n* Patients who have evidence of active or acute diverticulitis, intra-abdominal abscess, and gastrointestinal (GI) obstruction, within 12 months are not eligible\n* Women of childbearing potential must have a negative pregnancy test =\\< 7 days prior to registration\n\n  * Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Post menopause is defined as amenorrhea \\>= 12 consecutive months. Note: women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antiestrogens, ovarian suppression or any other reversible reason\n* Pregnant women may not participate in this study because with cabozantinib, nivolumab, and ipilimumab have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with cabozantinib, nivolumab, and ipilimumab, breastfeeding should be discontinued if the mother is treated with these agents\n* The patient has received no cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 2 weeks before the first dose of study treatment\n* The patient has received no radiation therapy:\n\n  * To the lungs and mediastinum or abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To brain metastasis within 3 weeks for whole-brain radiotherapy (WBXRT), and 2 weeks for stereotactic body radiation therapy (SBRT) before the first dose of study treatment\n  * To the abdomen within 4 weeks before the first dose of study treatment, or has ongoing complications, or is healing from prior radiation therapy\n  * To any other site(s) within 2 weeks before the first dose of study treatment\n* The patient has received no radionuclide treatment within 6 weeks of the first dose of study treatment\n* The patient has received no prior treatment with a small molecule kinase inhibitor within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment\n* The patient has received no prior treatment with hormonal therapy within 14 days or five half-lives of the compound or active metabolites, whichever is longer, before the first dose of study treatment. Subjects receiving gonadotropin-releasing hormone (GnRH) agonists and antagonists are allowed to participate\n* The patient has not received any other type of investigational agent within 14 days before the first dose of study treatment\n* The patient must have recovered to baseline or Common Terminology Criteria for Adverse Events (CTCAE) =\\< grade 1 from toxicity due to all prior therapies except alopecia, neuropathy and other non-clinically significant adverse events (AEs) defined as lab elevation with no associated symptoms or sequelae\n* The patient may not have active brain metastases or epidural disease. Patients with brain metastases previously treated with whole brain radiation or radiosurgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible. Neurosurgical resection of brain metastases or brain biopsy is permitted if completed at least 3 months before starting study treatment. Baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility\n* No concomitant treatment with warfarin. Aspirin (up to 325 mg/day), thrombin or factor Xa inhibitors, low-dose warfarin (=\\< 1 mg/day), prophylactic and therapeutic low molecular weight heparin (LMWH) are permitted\n* No chronic concomitant treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's wort) or strong CYP3A4 inhibitors\n\n  * Because the lists of these agents are constantly changing, it is important to regularly consult medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* The patient has not experienced any of the following:\n\n  * Clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment\n  * Hemoptysis of \\>= 0.5 teaspoon (2.5 mL) of red blood per day within 1 months before the first dose of study treatment\n  * Any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment\n* The patient has no tumor invading any major blood vessels\n* The patient has no evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. Patients with rectal tumor masses are not eligible\n* The patient has no uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:\n\n  * Cardiovascular disorders including:\n\n    * Congestive heart failure (CHF): New York Heart Association (NYHA) class III (moderate) or class IV (severe) at the time of screening.\n    * Concurrent uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic, or \\> 90 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment\n    * The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms within 28 days before randomization. Note: if initial QTcF is found to be \\> 500 ms, two additional electrocardiograms (EKGs) separated by at least 3 minutes should be performed. If the average of these three consecutive results for QTcF is =\\< 500 ms, the subject meets eligibility in this regard\n    * Any history of congenital long QT syndrome\n    * Any of the following within 6 months before registration of study treatment:\n\n      * Unstable angina pectoris\n      * Clinically-significant cardiac arrhythmias (patients with atrial fibrillation are eligible)\n      * Stroke (including transient ischemic attack \\[TIA\\], or other ischemic event)\n      * Myocardial infarction\n      * Cardiomyopathy\n  * No significant gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:\n\n    * Any of the following that have not resolved within 28 days before the first dose of study treatment:\n\n      * Active peptic ulcer disease\n      * Acute diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or malabsorption syndrome\n    * None of the following within 2 years before the first dose of study treatment:\n\n      * Abdominal fistula or genitourinary fistula\n      * Gastrointestinal perforation\n      * Bowel obstruction or gastric outlet obstruction\n      * Intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more than 2 years before the first dose of study treatment\n  * Disorders associated with a high risk of fistula formation including percutaneous endoscopic gastrostomy (PEG) tube placement are not eligible\n  * No other clinically significant disorders such as:\n\n    * Severe active infection requiring IV systemic treatment within 14 days before the first dose of study treatment\n    * Serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment\n    * History of organ or allogeneic stem cell transplant\n    * Concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment (for asymptomatic patients with an elevated thyroid-stimulating hormone \\[TSH\\], thyroid replacement may be initiated if clinically indicated without delaying the start of study treatment)\n  * No history of major surgery as follows:\n\n    * Major surgery within 3 months of the first dose of cabozantinib; however, if there were no wound healing complications, patients with rapidly growing aggressive cancers, may start as soon as 6 weeks if wound has completely healed post-surgery\n    * Minor surgery within 1 month of the first dose of cabozantinib if there were no wound healing complications or within 3 months of the first dose of cabozantinib if there were wound complications excluding core biopsies and mediport placement\n    * Complete wound healing from prior surgery must be confirmed before the first dose of cabozantinib irrespective of the time from surgery\n* No history of severe hypersensitivity reaction to any monoclonal antibody\n* No evidence of active malignancy, requiring systemic treatment within 2 years of registration\n* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to cabozantinib, nivolumab, ipilimumab or other agents used in study\n* No positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection. If HBV sAG is positive, subsequent ribonucleic acid (RNA) polymerase chain reaction (PCR) must be negative\n* No patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include, but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Oncology Centre","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kingman Regional Medical Center","city":"Kingman","state":"Arizona","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-Orange Grove Campus","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"CHI Saint Vincent Cancer Center Hot Springs","city":"Hot Springs","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Mission Hope Medical Oncology - Arroyo Grande","city":"Arroyo Grande","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"PCR Oncology","city":"Arroyo Grande","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Providence Saint Joseph Medical Center/Disney Family Cancer Center","city":"Burbank","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Community Cancer Institute","city":"Clovis","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Oncology Associates","city":"Clovis","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Epic Care-Dublin","city":"Dublin","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Bay Area Breast Surgeons Inc","city":"Emeryville","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Epic Care Partners in Cancer Care","city":"Emeryville","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Marin Cancer Care Inc","city":"Greenbrae","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Keck Medicine of USC Koreatown","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA / Jonsson Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Contra Costa Regional Medical Center","city":"Martinez","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Oncology/Hematology-Newport Beach","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alta Bates Summit Medical Center - Summit Campus","city":"Oakland","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Bay Area Tumor Institute","city":"Oakland","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Pacific Central Coast Health Center-San Luis Obispo","city":"San Luis Obispo","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mission Hope Medical Oncology - Santa Maria","city":"Santa Maria","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Epic Care Cyberknife Center","city":"Walnut Creek","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Penrose-Saint Francis Healthcare","city":"Colorado Springs","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers-Penrose","city":"Colorado Springs","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Porter","city":"Denver","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"CommonSpirit Cancer Center Mercy","city":"Durango","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center","city":"Durango","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CommonSpirit Saint Anthony Hospital Cancer Center","city":"Lakewood","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Littleton","city":"Littleton","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Longmont United Hospital","city":"Longmont","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers-Longmont","city":"Longmont","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Parker","city":"Parker","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Mary Corwin Medical Center","city":"Pueblo","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"MedStar Georgetown University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Comprehensive Cancer Center at Aventura","city":"Aventura","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"Miami Beach","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital/Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Saint Joseph's Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Emory Johns Creek Hospital","city":"Johns Creek","state":"Georgia","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Boise","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Boise","city":"Boise","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Caldwell","city":"Caldwell","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Walter Knox Memorial Hospital","city":"Emmett","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Fruitland","city":"Fruitland","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Idaho Urologic Institute-Meridian","city":"Meridian","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Meridian","city":"Meridian","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Twin Falls","city":"Twin Falls","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"OSF Saint Anthony's Health Center","city":"Alton","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Rush-Copley Medical Center","city":"Aurora","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Bloomington","city":"Bloomington","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Loyola Center for Health at Burr Ridge","city":"Burr Ridge","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Canton","city":"Canton","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Memorial Hospital of Carbondale","city":"Carbondale","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"SIH Cancer Institute","city":"Carterville","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Carthage","city":"Carthage","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rush MD Anderson Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois - Decatur","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Decatur Memorial Hospital","city":"Decatur","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Dixon","city":"Dixon","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crossroads Cancer Center","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Eureka","city":"Eureka","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Galesburg","city":"Galesburg","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Western Illinois Cancer Treatment Center","city":"Galesburg","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Loyola Medicine Homer Glen","city":"Homer Glen","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Kewanee Clinic","city":"Kewanee","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern Medicine Lake Forest Hospital","city":"Lake Forest","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Macomb","city":"Macomb","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loyola University Medical Center","city":"Maywood","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marjorie Weinberg Cancer Center at Loyola-Gottlieb","city":"Melrose Park","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"SSM Health Good Samaritan","city":"Mount Vernon","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"UC Comprehensive Cancer Center at Silver Cross","city":"New Lenox","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Rush MD Anderson Cancer Center at Rush Oak Park","city":"Oak Park","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of Chicago Medicine-Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Ottawa Clinic","city":"Ottawa","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Illinois CancerCare-Pekin","city":"Pekin","state":"Illinois","country":"United 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pillion-nebraska","carson-city-nevada","henderson-nevada","las-vegas-nevada","pahrump-nevada","reno-nevada","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","brooklyn-new-york","buffalo-new-york","commack-new-york","harrison-new-york","lake-success-new-york","mineola-new-york","new-york-new-york","rochester-new-york","syracuse-new-york","uniondale-new-york","chapel-hill-north-carolina","hendersonville-north-carolina","fargo-north-dakota","jamestown-north-dakota","beavercreek-ohio","belpre-ohio","boardman-ohio","centerville-ohio","chillicothe-ohio","cincinnati-ohio","columbus-ohio","dayton-ohio","delaware-ohio","dublin-ohio","findlay-ohio","franklin-ohio","gahanna-ohio","greenville-ohio","grove-city-ohio","kettering-ohio","lancaster-ohio","lima-ohio","mansfield-ohio","marietta-ohio","marion-ohio","marysville-ohio","mount-vernon-ohio","newark-ohio","perrysburg-ohio","portsmouth-ohio","springfield-ohio","toledo-ohio","troy-ohio","warren-ohio","west-chester-ohio","westerville-ohio","youngstown-ohio","zanesville-ohio","lawton-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","baker-city-oregon","bend-oregon","clackamas-oregon","coos-bay-oregon","newberg-oregon","ontario-oregon","oregon-city-oregon","portland-oregon","redmond-oregon","allentown-pennsylvania","bethlehem-pennsylvania","east-stroudsburg-pennsylvania","erie-pennsylvania","greensburg-pennsylvania","hazleton-pennsylvania","jefferson-hills-pennsylvania","monroeville-pennsylvania","n-huntingdon-pennsylvania","natrona-heights-pennsylvania","pittsburgh-pennsylvania","wexford-pennsylvania","charleston-south-carolina","alcoa-tennessee","franklin-tennessee","knoxville-tennessee","nashville-tennessee","bryan-texas","dallas-texas","fort-worth-texas","richardson-texas","aberdeen-washington","bellevue-washington","bellingham-washington","burien-washington","centralia-washington","edmonds-washington","enumclaw-washington","everett-washington","federal-way-washington","issaquah-washington","kennewick-washington","lacey-washington","lakewood-washington","longview-washington","poulsbo-washington","renton-washington","seattle-washington","sedro-woolley-washington","shelton-washington","silverdale-washington","tacoma-washington","vancouver-washington","walla-walla-washington","yakima-washington","yelm-washington","ashland-wisconsin","burlington-wisconsin","cudahy-wisconsin","eau-claire-wisconsin","germantown-wisconsin","grafton-wisconsin","green-bay-wisconsin","kenosha-wisconsin","marinette-wisconsin","marshfield-wisconsin","milwaukee-wisconsin","minocqua-wisconsin","mukwonago-wisconsin","new-richmond-wisconsin","oconomowoc-wisconsin","oshkosh-wisconsin","racine-wisconsin","rice-lake-wisconsin","sheboygan-wisconsin","stevens-point-wisconsin","summit-wisconsin","two-rivers-wisconsin","waukesha-wisconsin","wauwatosa-wisconsin","west-allis-wisconsin","weston-wisconsin","cody-wyoming","sheridan-wyoming","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 2: testing Cabozantinib S-malate for Bladder Adenocarcinoma","inPlainEnglish":"This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Metastatic disease defined as new or progressive lesions on cross-sectional imaging or bone scan. Patients must have at least:","One measurable site of disease as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1","One bone lesion on bone scan (tec99 or sodium fluoride \\[NaF\\] PET/CT, CT or MRI) for the bone-only cohort","Histologically confirmed diagnosis of one of the following metastatic cohorts:","Adenocarcinoma of the bladder, or urachal adenocarcinoma, or bladder/urethra clear cell adenocarcinoma (Cohort B) - must be pure (per World Health Organization \\[WHO\\] definition), (i.e. urothelial carcinoma with glandular differentiation is not considered a pure adenocarcinoma","Squamous cell carcinoma of the bladder (Cohort C) - must be pure (i.e. urothelial carcinoma with squamous differentiation is not considered a pure squamous cell carcinoma)","Plasmacytoid urothelial carcinoma (Cohort D) - Tumor should show predominantly \\> or equal \\~ 50% plasmacytoid histology (including all types of discohesive growth, such as tumors with signet-ring and/or rhabdoid features as well)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Scan, or Cabozantinib S-malate. The registry lists allocation as na. This phase II trial studies how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that has spread from where it first started (primary site) to other places in the body.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 314 people at 582 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.912Z"},{"nctId":"NCT03884075","title":"Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","officialTitle":"Non-Alcoholic Fatty Liver Disease, the Hepatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Background:\n\nIn non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.\n\nObjective:\n\nTo find out how the liver in people with NAFLD responds to feeding, and how this relates to their response to the drug semaglutide.\n\nEligibility:\n\nPeople with NAFLD and healthy volunteers ages 18 and older\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood tests\n\nImaging: A machine will take pictures of the participant s body.\n\nWithin 2-8 weeks of enrollment, participants will stay in the clinic for several days. This includes:\n\nBlood, urine, heart, and imaging tests\n\nFor NAFLD participants only: A needle-like device will remove a small biopsy of the liver and fatty tissue.\n\nParticipants will be alone in a special room for 5 hours. They will breathe through a tube under the nostrils. They will have blood drawn several times.\n\nThe baseline visit concludes participation for healthy volunteers but NAFLD participants will contine.\n\nAbout 6 weeks after discharge, participants will stay in the clinic again and repeat the tests. They will get their first semaglutide dose by injection.\n\nParticipants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits include blood tests.\n\nParticipants will inject semaglutide once a week at home.\n\nAt week 30, participants will stay in the clinic again and repeat the tests.\n\nParticipants will have a final visit 12 weeks after stopping treatment. This includes blood and urine tests.\n\n...","conditions":["Non-Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease"],"keywords":["Non-Alcoholic Steatohepatitis (NASH)","Steatosis","Caloric Load"],"interventions":[{"type":"DRUG","name":"Semaglutide"}],"enrollment":104,"startDate":"2019-07-24","completionDate":"2028-08-31","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Male or female Aged \\>= 18 years of age.\n  2. Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \\>= 285 db/M25) within 12 months.\n  3. Estimated average alcohol consumption \\< 30 g/d for men or \\< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior.\n  4. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nAdditional Inclusion Criteria for Treatment Phase\n\n1. Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy.\n2. Liver fat content greater than or equal to 10% by 1H-MRS on initial admission.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant or breast-feeding\n2. Chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who were treated successfully for HCV and achieved sustained virological response can be eligible for enrollment \\> 18 months after treatment cessation. Patients receiving antiviral therapy are ineligible.\n3. HIV infection.\n4. Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis.\n5. Presence of definite or probable drug-induced liver injury. In the case of lipid-lowering, anti-hypertensive or anti-diabetic medications that are suspected to cause aminotransferase elevation, patients will be eligible if treatment is associated with stable enzyme levels for at least 6 months.\n6. Decompensated advanced liver disease, defined as direct bilirubin \\> 0.5 g/dL, PT \\> 18 , albumin \\< 3 g/dL, MELD score \\> 12 (applicable only in patients without Gilbert s syndrome), or history of ascites, encephalopathy, variceal bleeding, spontaneous bacterial peritonitis or liver transplant\n7. Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen\n8. Uncontrolled hypo- or hyperthyroidism.\n9. Thyroid nodules with ultrasonographic features suggestive of an increased risk of thyroid cancer per radiologist reporting (hypoechoic, microcalcifications, twinkling on B flow imaging, central vascularity, irregular margins, incomplete halo, nodule taller than wide and documented enlargement of a nodule), or nodules associated with an abnormal TSH (0.4 to 5 mU/L).\n10. Active coronary artery disease, defined as persistent angina pectoris, reversible ischemia on cardiac stress test or imaging, or the presence of significant coronary artery disease on imaging or catheterization. Patients with coronary artery disease that was treated by angioplasty or bypass surgery may be eligible if they have no evidence of active disease \\>= 1 year after intervention, can safely stop antiplatelet and anticoagulant medications before the performance of invasive procedures, and have adequate ventricular function as assessed by echocardiography or cardiology consultation. These patients will require cardiology consultation and clearance prior to enrollment.\n11. Congestive heart failure.\n12. Chronic kidney disease, with creatinine clearance \\< 60 ml/min or eGFR \\< 60/ml/min/m(2).\n13. Uncontrolled diabetes mellitus with HbA1c \\> 9% will exclude subjects. Patients with diabetes may be enrolled only if they have HbA1c \\<=9%, have been on stable therapy with lifestyle and/or metformin for at least 3 months prior to enrollment, and are not foreseen to require change of antidiabetic medication or dose during the trial.\n14. Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment.\n15. Contraindication or inability to perform a liver biopsy.\n\n    1. Patients with coagulopathy (PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of the normal, including treatment with oral and parenteral anticoagulants), thrombocytopenia (\\< 70,000), abnormal bleeding time or platelet dysfunction. Antiplatelet agents taken for cardiovascular prevention will not exclude patients, unless they cannot be stopped safely for the performance of a liver biopsy.\n    2. Hemoglobin level \\< 11 g/dL\n16. Contraindications to MRI (heart pacemakers, unless MRI safe, insulin pumps, implanted hearing aids, neurostimulators, intracranial metal clips, metallic bodies in the eye, metal hip replacements, sutures, extreme anxiety or fear of small spaces.)\n17. History of gastric bypass or other bariatric surgery, partial or complete gastrectomy and known maldigestion or malabsorption.\n18. Treatment with orlistat.\n19. Patients with uncontrolled eating disorders including anorexia and bulimia nervosa.\n20. Patients with proliferative diabetic retinopathy.\n21. Use of medications or supplements to treat NAFLD (approved or unapproved) unless withdrawn greater than or equal to 3 months prior to enrollment or taken at a stable dose for greater than or equal to 6 months.\n22. Patients who had a liver biopsy performed less than or equal to 2 years before enrollment, unless they are willing to undergo all of the trial biopsies, knowing that these biopsies are purely for research and are not clinically indicated. This will be clearly documented in the patients charts prior to enrollment.\n23. Inability or unwillingness to receive subcutaneous injections.\n24. Known or suspected allergy to trial medication(s), excipients, or related products.\n25. Alcohol or substance abuse within the past 12 months.\n26. For women of childbearing potential, breast-feeding, pregnancy or inability or unwillingness to practice contraception for the duration of the study.\n27. Personal or first-degree family member with history of medullary thyroid carcinoma or subjects with known multiple endocrine neoplasia syndrome type 2 (MEN-2).\n28. Actively pursuing an intensive weight loss regiment, aimed at losing \\> 10% of current body weight, by following a different diet or exercise regimen over the study time period or recent (\\<3 months) significant weight loss (\\>10%).\n29. The receipt of any investigational drug within 3 months prior to enrollment in this trial.\n30. Assessment by the principal investigator that the subject will be unlikely to complete the study procedures, or that enrollment puts the subject at a significant risk unspecified by the criteria above.\n\nINCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Male or female Aged greater than or equal to 18 years of age.\n2. No evidence of hepatic steatosis by imaging or histology.\n3. No history of known liver disease.\n4. Individuals on regular systemic medications may be considered eligible, and their eligibility will be determined by the principal investigator.\n5. BMI less than or equal to 25 kg/m2\n6. Non-diabetic.\n7. Normal transaminases (ALT less than or equal to 31 U/L for men or less than or equal to 19 U/L for women, and AST less than or equal to 30 U/L).\n8. Fasting glucose less than or equal to 95 mg/dL.\n9. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA for Healthy Volunteers (arm C)\n\n1. Pregnant or breastfeeding\n2. Excessive alcohol consumption, defined as an average alcohol consumption over \\> 1 drink per day over the past month\n3. Assessment by the principal investigator that the subject is unsuitable for participation in the study or that enrollment puts the subject at significant risk.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yaron Rotman, M.D.","phone":"(301) 451-6553","email":"rotmanyaron@mail.nih.gov"}],"primaryOutcomes":["Histological Improvement","Clinical Improvement","Change in hepatic gene expression"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["semaglutide"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Semaglutide for Non-Alcoholic Steatohepatitis","inPlainEnglish":"Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication can help.","whoItsFor":["Ages 18 Years to 100 Years","Male or female Aged \\>= 18 years of age","Histological evidence of hepatic steatosis on a liver biopsy within 12 months OR evidence of fatty liver disease, as documented by imaging (ultrasound, CT, MRI, MRI-PDFF, MR spectroscopy, or Fibroscan CAP \\>= 285 db/M25) within 12 months","Estimated average alcohol consumption \\< 30 g/d for men or \\< 20 g/d for women in the 6 months prior to enrollment and no binge-drinking behavior","Additional who can join for Treatment Phase","Presence of NAFLD (steatosis grade greater than or equal to 1 on NASH-CRN scoring scale) on baseline admission liver biopsy","Liver fat content greater than or equal to 10% by 1H-MRS on initial admission"],"whoShouldSkip":["Pregnant or breast-feeding","Concomitant liver disease such as autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson s disease, alpha-1 antitrypsin deficiency, hereditary hemochromatosis","Treatment with medications known to cause fatty liver disease such as atypical neuroleptics, tetracycline, methotrexate or tamoxifen","Uncontrolled hypo- or hyperthyroidism","Congestive heart failure","Chronic kidney disease, with creatinine clearance \\< 60 ml/min or eGFR \\< 60/ml/min/m(2)","Use of insulin, sulfonylurea agents, thiazolidinediones, SGLT2 inhibitors, GLP-1 receptor agonists or DPP-4 inhibitors unless discontinued greater than or equal to 3 months before enrollment"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide. The registry lists allocation as randomized. Background: In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause damage.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 104 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.152Z"},{"nctId":"NCT03899155","title":"Pan Tumor Rollover Study","officialTitle":"Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.","conditions":["Cancer"],"keywords":["Rollover","pan-tumor"],"interventions":[{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Ipilimumab"},{"type":"DRUG","name":"Cabozantinib"},{"type":"DRUG","name":"Trametinib"},{"type":"DRUG","name":"Relatlimab"},{"type":"DRUG","name":"Nivolumab + Relatlimab"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Temozolomide"},{"type":"DRUG","name":"Rucaparib"},{"type":"DRUG","name":"Daratumumab"},{"type":"DRUG","name":"Regorafinib"},{"type":"DRUG","name":"Leucovorin"},{"type":"DRUG","name":"Fluorouracil"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Enzalutamide"},{"type":"DRUG","name":"Sunitinib"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":1500,"startDate":"2019-08-09","completionDate":"2029-08-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Signed Written Informed Consent.\n* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.\n* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.\n* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.\n\nExclusion Criteria\n\n* Participant is not eligible for study treatment per the Parent Study eligibility criteria.\n* Participants not receiving clinical benefit as assessed by the Investigator.\n* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.\n* Other protocol-defined Inclusion/Exclusion Criteria apply","locations":[{"facility":"Local Institution - 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.993Z"},{"nctId":"NCT03941756","title":"Lymphovenous Bypass Procedure Before Underarm Lymph Node Surgery in Preventing Lymphedema in Patients With Inflammatory or Locally Advanced Non-inflammatory Breast Cancer or Melanoma","officialTitle":"Prophylactic Lymphovenous Bypass Procedure Following Axillary Lymphadenectomy: A Prospective Observational Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms. It is usually done after a diagnosis of lymphedema. In this study, giving lymphovenous bypass before underarm lymph node surgery may help prevent lymphedema from forming.","conditions":["Anatomic Stage III Breast Cancer AJCC v8","Breast Inflammatory Carcinoma","Locally Advanced Breast Carcinoma","Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Indocyanine Green"},{"type":"PROCEDURE","name":"Lymphangiography"},{"type":"PROCEDURE","name":"Lymphovenous Bypass"}],"enrollment":252,"startDate":"2018-08-14","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients greater than or equal to 18 years of age.\n* Patients willing to participate.\n* Patients able to complete informed consent.\n* Patients will be eligible for inclusion if they fall into one for two groups:\n\n  * Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy\n  * Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group.\n\nExclusion Criteria:\n\n* Patients taking anticoagulants within 7 days prior to surgery.\n* Patients that are known to be pregnant at the time of surgery.\n* Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.\n* Patients with body mass index (BMI) greater than 50.0.","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Volumetric diagnosis of lymphedema","Incidence of lymphedema"],"hasResults":false,"conditionSlugs":["breast-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: testing Indocyanine Green for Anatomic Stage III Breast Cancer AJCC v8","inPlainEnglish":"This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma. The lymphovenous bypass procedure creates a path for lymphatic fluid to flow away from the arms.","whoItsFor":["Ages 18 Years to any","Patients greater than or equal to 18 years of age","Patients will be eligible for inclusion if they fall into one for two groups:","Patients with inflammatory breast cancer, and those with locally advanced non-inflammatory breast cancer that are undergoing ALND and are anticipated to receive radiation therapy","Or: Patients with a diagnosis of melanoma (including unknown primary) that will undergo ALND will also be eligible for inclusion in the study as a comparator group"],"whoShouldSkip":["Patients taking anticoagulants within 7 days prior to surgery","Patients that are known to be pregnant at the time of surgery","Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period","Patients with body mass index (body-mass index (BMI)) greater than 50.0"],"whatHappens":"If you join, the listed intervention(s) are Indocyanine Green, Lymphangiography, or Lymphovenous Bypass. The registry lists allocation as randomized. This pilot trial studies whether a procedure called lymphovenous bypass would prevent lymphedema (arm swelling) in patients with inflammatory breast cancer or non-inflammatory breast cancer that has spread to nearby tissues or lymph nodes or melanoma.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 252 people at Houston. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.958Z"},{"nctId":"NCT03963622","title":"Careful Ventilation in Acute Respiratory Distress Syndrome (COVID-19 and Non-COVID-19)","officialTitle":"Careful Ventilation in Acute Respiratory Distress Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Unity Health Toronto","sponsorClass":"OTHER","summary":"This is a multicenter randomized controlled clinical trial with an adaptive design assessing the efficacy of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS).\n\nThe CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations. CAVIARDS consists of an identical 2-arm mechanical ventilation protocol implemented in two different study populations (COVID-19 and non-COVID-19 patients). As per a typical basket trial design, the operational structure of both the COVID-19 substudy (CAVIARDS-19) and non-COVID-19 substudy (CAVIARDS-all) is shared (recruitment, procedures, data collection, analysis, management, etc.).","conditions":["ARDS"],"keywords":["Ventilation","ARDS","Airway closure","Lung recruitment","COVID-19","Basket trial"],"interventions":[{"type":"OTHER","name":"Respiratory Mechanics"},{"type":"OTHER","name":"Standard Ventilation Strategy"}],"enrollment":740,"startDate":"2020-11-23","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 y\n2. Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became \\> 200 mm Hg under prone positioning when starting the protocol remained eligible)\n\nExclusion Criteria:\n\n1. Received continuous mechanical ventilation \\> 7 days\n2. Known or clinically suspected elevated intracranial pressure (\\>18mmHg) necessitating strict control of PaCO2\n3. Known pregnancy\n4. Broncho-pleural fistula\n5. Severe liver disease (Child-Pugh Score ≥ 10)\n6. BMI \\>40kg/m2\n7. Anticipating withdrawal of life support and/or shift to palliation as the goal of care\n8. Patient is receiving ECMO at time of randomization","locations":[{"facility":"New York University Grossman School of Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Educación Médica e Investigaciones Clínicas Dr Norberto Quirno (CEMIC)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Médico Policía Federal Argentina Churruca Visca","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Británico de Buenos Aires","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Anchorena Recoleta","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Mater Dei","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Anchorena San Martín","city":"San Martin","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Michael's Hospital","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto General Hospital","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto Western Hospital","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Católica de Chile","city":"Santiago","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Amiens-Picardie","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier universitaire d'Angers","city":"Angers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH Victor Dupouy","city":"Argenteuil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH de Beauvais","city":"Beauvais","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Bordeaux - 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La Miletrie","city":"Poitiers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH Bretagne Atlantique Vannes-Auray","city":"Vannes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HIA Robert Picque","city":"Villenave-d'Ornon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcispedale Sant'Anna","city":"Ferrara","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Foggia","city":"Foggia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Universitario Agostino Gemelli IRCCS","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"OLVG","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"L'Hospital de la Santa Creu i Sant Pau","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall d'Hebron University Hospital","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laurent Brochard, MD","phone":"416-864-6060","email":"laurent.brochard@unityhealth.to"}],"primaryOutcomes":["All-cause 60-day mortality"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["new-york-new-york","buenos-aires-argentina","san-martin-argentina","toronto-canada","santiago-chile","amiens-france","angers-france","argenteuil-france","beauvais-france","bordeaux-france","brest-france","cholet-france","cr-teil-france","grenoble-france","lille-france","mulhouse-france","nice-france","paris-france","poitiers-france","vannes-france","villenave-dornon-france","ferrara-italy","foggia-italy","rome-italy","amsterdam-netherlands","barcelona-spain"],"enrichment":{"headline":"Not a traditional drug phase: Respiratory Mechanics for ARDS","inPlainEnglish":"This is a multicenter randomly assigned controlled clinical trial with an adaptive design assessing the how well it works of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS). The CAVIARDS study is also a basket trial; a basket trial design examines a single intervention in multiple disease populations.","whoItsFor":["Ages 18 Years to any","Moderate or severe ARDS (PaO2/FiO2 ≤ 200 mmHg) within 48 h of meeting Berlin ARDS criteria (Patients who were eligible at the time of screening and whose PaO2/FiO2 became \\> 200 mm Hg under prone positioning when starting the protocol remained eligible)"],"whoShouldSkip":["Received continuous mechanical ventilation \\> 7 days","Known or clinically suspected elevated intracranial pressure (\\>18mmHg) necessitating strict control of PaCO2","Broncho-pleural fistula","Severe liver disease (Child-Pugh Score ≥ 10)","Anticipating withdrawal of life support and/or shift to palliation as the goal of care","Patient is receiving ECMO at time of randomization"],"whatHappens":"If you join, the listed intervention(s) are Respiratory Mechanics, or Standard Ventilation Strategy. The registry lists allocation as randomized. This is a multicenter randomly assigned controlled clinical trial with an adaptive design assessing the how well it works of setting the ventilator based on measurements of respiratory mechanics (recruitability and effort) to reduce Day 60 mortality in patients with acute respiratory distress syndrome (ARDS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 740 people at 33 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.069Z"},{"nctId":"NCT03970447","title":"A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma","officialTitle":"GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Global Coalition for Adaptive Research","sponsorClass":"OTHER","summary":"Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.\n\nAll institutions are enrolling Newly Diagnosed participants. Institutions also enrolling Recurrent participants are marked with an asterisk (\\*).","conditions":["Glioblastoma"],"keywords":["Glioblastoma","Newly diagnosed","recurrent","O6-methylguanine-DNA-methyltransferase (MGMT) methylated","MGMT unmethylated","isocitrate dehydrogenase (IDH) wild-type","Bayesian","adaptive randomization","Master Protocol","Platform Trial","Phase 2","Phase 3"],"interventions":[{"type":"DRUG","name":"Temozolomide"},{"type":"DRUG","name":"Lomustine"},{"type":"DRUG","name":"Regorafenib"},{"type":"RADIATION","name":"Radiation"},{"type":"DRUG","name":"Paxalisib"},{"type":"DRUG","name":"VAL-083"},{"type":"DRUG","name":"VT1021"},{"type":"DRUG","name":"Troriluzole"},{"type":"BIOLOGICAL","name":"ADI-PEG 20"},{"type":"DRUG","name":"AZD1390"},{"type":"DRUG","name":"Tinostamustine"}],"enrollment":2250,"startDate":"2019-07-30","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Newly Diagnosed Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.\n* Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from definitive surgery or biopsy.\n\nRecurrent Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \\[IHC\\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).\n* Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.\n* Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.\n* Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.\n* Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.\n\nNewly Diagnosed Exclusion Criteria:\n\n* Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.\n\nRecurrent Exclusion Criteria:\n\n* Early disease progression prior to 3 months (12 weeks) from the completion of RT.\n* More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)\n* Received any prior treatment with lomustine, agents part of any of the experimental arms, or bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.\n* Any prior treatment with prolifeprospan 20 with carmustine wafer.\n* Any prior treatment with an intracerebral agent.\n* Receiving additional, concurrent, active therapy for GBM outside of the trial\n* Extensive leptomeningeal disease.\n* QTc \\> 470 msec\n* History of another malignancy in the previous 2 years, with a disease-free interval of \\< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Hospital","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Center","city":"Stanford","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Colorado Denver","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Cancer Center / Smilow Cancer Hospital*","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Cancer Center","city":"Jacksonville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sylvester Comprehensive Cancer Center*","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Atlanta Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute of Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"LSU Health Sciences Center - 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Wertheimer","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital de la Timone","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Piti-Salpetriere","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie","city":"Cologne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr. Senckenbergisches Institut für Neuroonkologie","city":"Frankfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Heidelberg","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Heidelberg - Neurologische Klinik","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Regensburg","city":"Regensburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire Vaudois Lausanne","city":"Lausanne","state":"Canton of Vaud","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Zurich","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patient Information","phone":"310-598-3199","email":"patientinfo@gcaresearch.org"},{"name":"Sarah Untch","phone":"","email":"suntch@gcaresearch.org"}],"primaryOutcomes":["Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["glioblastoma","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","la-jolla-california","los-angeles-california","orange-california","san-francisco-california","stanford-california","aurora-colorado","new-haven-connecticut","jacksonville-florida","miami-florida","tampa-florida","atlanta-georgia","new-orleans-louisiana","boston-massachusetts","detroit-michigan","minneapolis-minnesota","rochester-minnesota","jackson-mississippi","st-louis-missouri","new-york-new-york","durham-north-carolina","winston-salem-north-carolina","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","charleston-south-carolina","austin-texas","dallas-texas","houston-texas","salt-lake-city-utah","charlottesville-virginia","seattle-washington","milwaukee-wisconsin","st-leonards-australia","waratah-australia","herston-australia","bedford-park-australia","heidelberg-australia","melbourne-australia","toronto-canada","montreal-canada","sherbrooke-canada","bron-france","marseille-france","paris-france","cologne-germany","frankfurt-germany","heidelberg-germany","mannheim-germany","regensburg-germany","t-bingen-germany","lausanne-switzerland","zurich-switzerland"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Temozolomide for Glioblastoma","inPlainEnglish":"Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. All institutions are enrolling Newly Diagnosed participants.","whoItsFor":["Ages 18 Years to any","Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization","Availability of tumor tissue representative of GBM from definitive surgery or biopsy","Recurrent who can join:","Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria","Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression","Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization","Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed"],"whoShouldSkip":["Extensive leptomeningeal disease","History of another malignancy in the previous 2 years, with a disease-free interval of \\< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible"],"whatHappens":"If you join, the listed intervention(s) are Temozolomide, Lomustine, or Regorafenib. The registry lists allocation as randomized. Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 2,250 people at 63 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.482Z"},{"nctId":"NCT03971487","title":"Ocrelizumab for Psychosis by Autoimmunity","officialTitle":"Ocrelizumab for Psychoses Possibly Caused by Synaptic Autoimmunity","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"The Methodist Hospital Research Institute","sponsorClass":"OTHER","summary":"Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to \"friendly fire.\" Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them. If this disease is caused by auto-antibodies, typically the person is well until they are 15 years of age or older, but seldom older than 35 years. Then, in a matter of a few months they begin to have hallucinations and the other symptoms. Doctors still do not know whether some people with schizophrenia or bipolar disease have auto-antibodies attacking their brain. For this reason, in this study some of these patients will receive a treatment that suppresses the auto-antibodies and their symptoms after treatment will be compared with the symptoms of a group of similar patients who are given a preparation that looks like the real treatment, but it is not.","conditions":["Schizo-Affective Type of Psychosis","Schizophrenia"],"keywords":["schizo-affective psychosis","schizophrenia"],"interventions":[{"type":"BEHAVIORAL","name":"Psychosis and cognitive assessments"},{"type":"BEHAVIORAL","name":"Physical and neuro-cognitive evaluations"},{"type":"DIAGNOSTIC_TEST","name":"Safety labs and electrocardiogram"},{"type":"BIOLOGICAL","name":"Ocrelizumab infusion"}],"enrollment":40,"startDate":"2019-10-01","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals of either sex, 18-35 years of age.\n* Having an active psychotic disorder meeting DSM-5 criteria, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI).\n* A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms.\n* Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age.\n* Ability to assent or consent to the performance of the study and participate in testing procedures.\n\nExclusion Criteria:\n\n* The dose of antipsychotic medication (if they are on one) has been changed less than two weeks prior to baseline PANSS testing (Visit 2, see below).\n* Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization.\n* Vaccinated with a live-attenuated vaccine less than 4 weeks before ocrelizumab infusion or with a non-live vaccine less than 2 weeks before infusion.\n* Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus, syphilis, tuberculosis, PML).\n* History of brain tumor, stroke, severe head trauma or multiple sclerosis.\n* Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease.\n* In the judgment of the PI, psychosis related to substance abuse or metabolic disorders.\n* Pregnancy or lactation.\n* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.\n* History of or currently active primary or secondary immunodeficiency.\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Contraindications to or intolerance of oral or IV corticosteroids.","locations":[{"facility":"Houston Methodist Research Institute","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joseph C Masdeu, MD, PhD","phone":"202-255-7899","email":"jcmasdeu@houstonmethodist.org"},{"name":"Haroon Shahid, MD","phone":"713-441-1150","email":"mhshahid@houstonmethodist.org"}],"primaryOutcomes":["Score on the Positive and Negative Syndrome Scale (PANSS)"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":["ocrelizumab"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Ocrelizumab infusion for Schizo-Affective Type of Psychosis","inPlainEnglish":"Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to \"friendly fire.\" Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.","whoItsFor":["Ages 18 Years to 35 Years","Individuals of either sex, 18-35 years of age","Having an active psychotic disorder meeting DSM-5 criteria, including a duration of at least six months, for Schizophrenia Spectrum Disorder, as defined by the Mini International Neuropsychiatric Interview (MINI)","A total PANSS ≥ 60 and a score ≥ 4 on at least 2 of the PANSS positive symptoms","Normal academic performance at least until the age of 15 years and absence of psychiatric symptoms before the same age","Ability to assent or consent to the performance of the study and participate in testing procedures"],"whoShouldSkip":["The dose of antipsychotic medication (if they are on one) has been changed less than two weeks prior to baseline PANSS testing (Visit 2, see below)","Patient treated with a medication designed to suppress the immune system, other than standard analgesics or antipyretics, in the six months prior to randomization","Vaccinated with a live-attenuated vaccine less than 4 weeks before ocrelizumab infusion or with a non-live vaccine less than 2 weeks before infusion","Active infection, or history of or known presence of recurrent or chronic infection (for example, hepatitis B or C, Human Immunodeficiency Virus, syphilis, tuberculosis, PML)","History of brain tumor, stroke, severe head trauma or multiple sclerosis","Active cancer, metabolic encephalopathy, severe cardiovascular or renal disease","In the judgment of the PI, psychosis related to substance abuse or metabolic disorders"],"whatHappens":"If you join, the listed intervention(s) are Psychosis and cognitive assessments, Physical and neuro-cognitive evaluations, or Safety labs and electrocardiogram. The registry lists allocation as randomized. Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Houston. Taking part typically means an infusion or injection of a biologic, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.994Z"},{"nctId":"NCT03972657","title":"A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors","officialTitle":"A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and/or cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor","conditions":["Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Clear Cell Renal Cell Carcinoma (ccRCC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"REGN5678"},{"type":"DRUG","name":"Cemiplimab"}],"enrollment":345,"startDate":"2019-08-12","completionDate":"2027-11-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n   1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n   2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor\n\nKey Exclusion Criteria:\n\n1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. Any condition that requires ongoing/continuous corticosteroid therapy (\\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with Activities of Daily Living \\[ADLs\\]) or uncontrolled seizures in the year prior to first dose of study therapy\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion/Exclusion Criteria apply","locations":[{"facility":"Banner MD Anderson Cancer Center","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Wayne Cancer Institute (JWCI)","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute (SCRI)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center - McKinley Drive","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health Perlmutter Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University - The Trustees of Columbia University in the City of New York","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Cancer Hospital and Solove Research Institute","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Portland Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Oregon Health & Science University (3485 S. Bond)","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lifespan Cancer Institute","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emily Couric Clinical Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea - St. Vincent's Hospital - Lung Cancer Center","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University - Severance Hospital - Colorectal Cancer Clinic","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)","Incidence and severity of Adverse Event of Special Interests (AESIs)","Incidence and severity of Serious Adverse Events (SAEs)","Number of participants with Grade ≥3 laboratory abnormalities","Incidence of Dose-Limiting Toxicities (DLTs)","Concentration of REGN5678 in serum over time","Concentration of REGN5678 in combination with cemiplimab in serum over time","Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)","Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria"],"hasResults":false,"conditionSlugs":["prostate-cancer","kidney-cancer"],"drugSlugs":[],"locationSlugs":["gilbert-arizona","phoenix-arizona","tucson-arizona","santa-monica-california","denver-colorado","new-haven-connecticut","jacksonville-florida","tampa-florida","boston-massachusetts","detroit-michigan","rochester-minnesota","new-york-new-york","rochester-new-york","columbus-ohio","portland-oregon","philadelphia-pennsylvania","providence-rhode-island","houston-texas","charlottesville-virginia","morgantown-west-virginia","suwon-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1 / Phase 2: testing REGN5678 for Metastatic Castration-Resistant Prostate Cancer (mCRPC)","inPlainEnglish":"The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab.","whoItsFor":["Ages 18 Years to any","mCRPC cohorts (men):","Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma","PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol","Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:","one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)","177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol","ccRCC cohorts (men and women):"],"whoShouldSkip":["Has received treatment with an approved systemic therapy within 3 weeks of dosing or has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities, as described in the protocol","Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol","Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC","Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy","Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol","Any condition that requires ongoing/continuous corticosteroid therapy (\\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy","Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol"],"whatHappens":"If you join, the listed intervention(s) are REGN5678, or Cemiplimab. The registry lists allocation as randomized. The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 345 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.914Z"},{"nctId":"NCT03973268","title":"Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression","officialTitle":"The Mechanism of Action Underlying Ketamine's Antidepressant Effects: An Investigation of the AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nMost drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works.\n\nObjective:\n\nTo see if the antidepressant response of ketamine is linked to AMPA receptors.\n\nEligibility:\n\nAdults ages 18-70 with major depression disorder without psychotic features\n\nDesign:\n\nParticipants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam.\n\nParticipants will stay at the NIH Clinical Center for 5 weeks.\n\nPhase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests:\n\n* Blood draws\n* Psychological tests\n* MRI: Participants will lie in a machine that takes pictures of their brain.\n* MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity.\n* Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep.\n* Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity.\n\nFor phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.","conditions":["Depression","Major Depressive Disorder","Major Depression"],"keywords":["Biomarker","AMPA Antagonist","Magnetoencephalography","Neuropharmacology","Neurobiology"],"interventions":[{"type":"DEVICE","name":"Arm 1, 2, 3 device interventions"},{"type":"OTHER","name":"Arm 2 Interventions"},{"type":"DRUG","name":"Arm 1, 2, 3 drug Interventions"},{"type":"DRUG","name":"Arm 1 and 2 Interventions"}],"enrollment":70,"startDate":"2020-01-21","completionDate":"2027-02-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPhases I-II\n\n1. 18 to 70 years of age.\n2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n3. All subjects must have undergone a screening assessment under protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\".\n4. Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P).\n5. Subjects must have an initial score on the MADRS \\>= 22 and a YMRS score of \\<12 within one week of study entry and upon entry into Phase II.\n6. Lack of response to two adequate antidepressant trials, with \\[at least\\] one in the current major depressive episode, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT \\[or TMS\\] would count as an adequate antidepressant trial.\n7. Current major depressive episode lasting at least four weeks\n8. Agree to be hospitalized\n\nOpen-Label Ketamine Treatment\n\n1. Participants must have met all inclusion criteria for and completed Study Phase II\n2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III.\n\nEXCLUSION CRITERIA:\n\nPhases I-II\n\n1. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n2. Subjects with a history of substance abuse or dependence diagnosis (DSM-IV) or substance use disorder (DSM-5 equivalent) (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) at screening.\n3. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease.\n4. Pregnant or nursing individuals or those who are physically able to become pregnant. Participants who are physically able to become pregnant or cause a pregnancy must use at least one form of effective birth control or remain completely abstinent from sexual intercourse during the entire period of study participation (or until the last clinical labs and ratings). Participants able to become pregnant must have negative urine pregnancy tests no more than 24 hours prior to receiving the study drugs and undergoing imaging procedures.\n5. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures.\n6. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.\n7. Clinically significant abnormal laboratory tests.\n8. (For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures\n9. Positive HIV test\n10. Weight \\> 119 kg\n11. Treatment with any concomitant psychiatric medication prior to entering Phase II. \\[Medications must be tapered during Phase I.\\]\n12. Treatment with any non-psychiatric medication/s.\n13. Any use of opioid medication in the past 3 months\n14. Treatment with a reversible monoamine oxidase inhibitor (MAOI) prior to entering Phase II. \\[Medications must be tapered during Phase I.\\]\n15. Treatment with fluoxetine or aripiprazole at the time of screening.\n16. Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study.)\n17. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clip).\n18. Participants who are uncomfortable in small closed spaces (have claustrophobia).\n19. Are unable to lie comfortably supine for up to 90 minutes and would feel uncomfortable in the MRI and MEG machines.\n20. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.\n21. Subjects who have a history of aggressive behavior towards others\n\nOpen-Label Ketamine Treatment\n\n1. Intolerable or serious adverse reaction to ketamine during Phase II\n2. Participants with a positive urine for an illicit substance no more than 24 hours prior to ketamine treatment.\n3. Pregnant or nursing individuals or those who plan to become pregnant.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yamila I Carmona","phone":"(301) 256-8971","email":"yamila.carmona@nih.gov"}],"primaryOutcomes":["Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion","Continued Antidepressant Efficacy: Change from baseline MADRS score post treatment with ketamine with perampanel versus placebo."],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Arm 1, 2, 3 drug Interventions for Depression","inPlainEnglish":"Background: Most drugs that treat mood disorders take a long time to work. Certain receptors in the brain might help ketamine work.","whoItsFor":["Ages 18 Years to 70 Years","18 to 70 years of age","All subjects must have undergone a screening assessment under protocol 01-M-0254, \"The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\"","Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P)","Subjects must have an initial score on the MADRS \\>= 22 and a YMRS score of \\<12 within one week of study entry and upon entry into Phase II","Current major depressive episode lasting at least four weeks","Agree to be hospitalized","Open-Label Ketamine Treatment"],"whoShouldSkip":["Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5","Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications","Clinically significant abnormal laboratory tests","(For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures","Treatment with any concomitant psychiatric medication prior to entering Phase II. \\[Medications must be tapered during Phase I.\\]","Treatment with any non-psychiatric medication/s","Any use of opioid medication in the past 3 months"],"whatHappens":"If you join, the listed intervention(s) are Arm 1, 2, 3 device interventions, Arm 2 Interventions, or Arm 1, 2, 3 drug Interventions. The registry lists allocation as randomized. Background: Most drugs that treat mood disorders take a long time to work.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 70 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.100Z"},{"nctId":"NCT03984253","title":"Swiss Severe Asthma Register","officialTitle":"Swiss Severe Asthma Register","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Prof. Dr. Jörg Leuppi","sponsorClass":"OTHER","summary":"Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity.\n\nDespite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma.\n\nBased on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death.\n\nSeveral severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods.\n\nApproximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated.\n\nFor all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.","conditions":["Severe Asthma"],"keywords":["Asthma","Severe","Register"],"interventions":[],"enrollment":600,"startDate":"2019-05-13","completionDate":"2034-02-28","sex":"ALL","minAge":"1 Year","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* In- and outpatients\n* Age ≥ 0 year\n* Informed consent as documented by signature\n\nAdults:\n\n\"Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:\n\n* High level therapy:\n\n  1. high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or\n  2. Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming \"uncontrolled\" or which remains \"uncontrolled\" despite this therapy or\n  3. Therapy with monoclonal antibodies independent from the co-therapy\n* Middle level therapy:\n\nProtokollsynopsis SAR Version 01 16.01.2019 Seite 4/10 a) Daily long-term therapy with medium-to high-dose ICS (≥500 μg Beclomethason (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year and uncontrolled asthma defined as at least one of the following:\n\n* Poor symptom control: ACQ consistently \\>1.5, ACT \\<20 (or \"not well controlled\" by NAEPP/GINA guidelines).\n* Frequent severe exacerbations: two or more bursts of systemic CS (\\>3 days each) in the previous year.\n* Serious exacerbations: at least one hospitalization, ICU stay or mechanical ventilation in the previous year.\n* Airflow limitation: after appropriate bronchodilator withhold FEV1 \\<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).\n* Controlled asthma that worsens on tapering of these high doses of ICS or systemic CS (or additional biologics). The presence of any one of the following exclusion criteria will lead to exclusion of the patients:\n* Life-expectancy \\<6 months\n* Insufficient knowledge of project language\n\nChildren:\n\nThe criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium/high antiinflammatory long-term therapy:\n\n* age 0-18 years, at time of inclusion\n* diagnosis of bronchial asthma made by a physician\n* differential diagnoses excluded\n* good compliance and trained inhalation technique\n* treatment with biological approved for the treatment of severe asthma (currently only omalizumab) or\n\nProof of:\n\na) Positive Bronchodilation-test (≥12% increase in FEV1 after SABA) or b) Significant bronchial hyperresponsiveness after nonspecific provocation (e.g., with Methacholine or treadmill) according to ATS criteria (AJRCCM 2000)\n\n* High level of therapy:\n\n  1. Prolonged therapy with high dose inhaled steroid (ICS) (\\> 400 μg Budesonide equivalent /\\> 200 μg fluticasone alone); or\n  2. Daily long-term therapy with medium- to high-dose ICS (≥ 400 μg Budesonide equivalent / ≥200 μg fluticasone) in combination with long-acting betaagonists and / or leukotriene receptor antagonist and / or theophylline; or\n  3. Therapy with oral steroids fixed ≥3 last months.\n* Insufficient asthma control\n\n  a) Inadequate symptom control after NVL in the last 4 weeks: Protokollsynopsis SAR Version 01 16.01.2019 Seite 5/10\n  * ≥3 x weekly asthma symptoms or use of ondemand medication; Or:\n  * limited activity due to asthma; Or:\n  * any symptoms at night; or b. Exacerbation(s) ≥1 last year that required treatment with systemic steroids and / or inpatient treatment c. limited lung function:\n  * pathological Tiffeneau quotient or FEV1 at inclusion.\n* Submission of a written consent (parent/ legal guardian).\n\nExclusion Criteria:\n\n* Life-expectancy \\<6 months · Insufficient knowledge of project language","locations":[{"facility":"Cantonal Hospital Baselland Liestal","city":"Liestal","state":"Basel-Landschaft","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik für Pneumologie, Inselspital","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pneumologie, Kantonsspital Graubünden","city":"Chur","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik für Pneumologie, Hochgebirgsklinik Davos","city":"Davos","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux Universitaires Genève","city":"Geneva","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier universitaire vaudoise","city":"Lausanne","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pneumologia, Ospedale Civico","city":"Lugano","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik für Pneumologie und Schlafmedizin, Kantonsspital St.Gallen","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital du valais, sion","city":"Sion","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik für Pneumologie, Universitätsspital Zürich","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jörg Leuppi","phone":"+41619252181","email":"Joerg.leuppi@ksbl.ch"}],"primaryOutcomes":["Symptom Control"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["liestal-switzerland","bern-switzerland","chur-switzerland","davos-switzerland","geneva-switzerland","lausanne-switzerland","lugano-switzerland","sankt-gallen-switzerland","sion-switzerland","zurich-switzerland"],"enrichment":{"headline":"Swiss Severe Asthma Register","inPlainEnglish":"Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction.","whoItsFor":["Ages 1 Year to any","In- and outpatients","\"Asthma which requires treatment with guidelines suggested medications for GINA steps 4-5 asthma:","High level therapy:","high dose ICS with ≥ 1000 μg beclomethasone (powder) or equivalent in combination with LABA or leukotriene modifier/theophylline) for the previous year or","Daily long-term therapy with systemic corticosteroids (CS) for ≥50% of the previous year to prevent it from becoming \"uncontrolled\" or which remains \"uncontrolled\" despite this therapy or","Therapy with monoclonal antibodies independent from the co-therapy","Middle level therapy:"],"whoShouldSkip":["will lead to exclusion of the patients:","Life-expectancy \\<6 months","Insufficient knowledge of project language","The criteria for severe or difficult asthma in children and adolescents are considered fulfilled in the case of insufficient symptom control in the last year despite medium/high antiinflammatory long-term therapy:","age 0-18 years, at time of inclusion","diagnosis of bronchial asthma made by a physician","differential diagnoses excluded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 600 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.350Z"},{"nctId":"NCT03998202","title":"Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer","officialTitle":"Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer: The M&M Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Wake Forest University Health Sciences","sponsorClass":"OTHER","summary":"This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.","conditions":["Colorectal Cancer","Sarcopenia"],"keywords":["Colorectal Cancer","Myopenia","Sarcopenia","Chemotherapy","Geriatric-Oncology"],"interventions":[],"enrollment":300,"startDate":"2019-09-23","completionDate":"2026-12-31","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \\>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC.\n* Planning to or recently started to undergo undergo immunotherapy and/or 5-FU based chemotherapy as a first line of treatment. 5-FU chemotherapy can be 5-FU alone or in combination with oxaliplatin and/or irinotecan +/- immunotherapy. Capecitabine is also acceptable. If unable to engage patient before treatment starts, enrollment is allowed up to four weeks after the start of treatment but must be before Cycle 2 begins.\n* Estimated life expectancy \\>= 6 months.\n* Patients must be able to comprehend English or Spanish (for questionnaire completion).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Patient eligibility is not dependent on BMI or weight. Patients with a significant (+- \\> 10%) body weight change in the previous 12 months are eligible for this study.\n\nExclusion Criteria:\n\n* Patients enrolled on hospice.\n* Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \\>= 3 months (12 weeks) prior to this disease disease recurrence and treatment).\n* Patients may not be receiving any other investigational agents. (For clarity, participants on the Alliance A021703 trial are also eligible for this study).\n* No untreated brain metastases. Patients with treated brain metastases are eligible.\n* Patients on or planned to undergo radiation therapy in near future.","locations":[{"facility":"Beebe South Coastal Health Campus","city":"Millville","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helen F Graham Cancer Center","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Hematology Consultants PA","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beebe Health Campus","city":"Rehoboth Beach","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Christiana Care Health System-Wilmington Hospital","city":"Wilmington","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Georgetown University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John B Amos Cancer Center","city":"Columbus","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Bloomington","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Canton","city":"Canton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SIH Cancer Institute","city":"Carterville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John H Stroger Jr Hospital of Cook County","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois - Decatur","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crossroads Cancer Center","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Galesburg","city":"Galesburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group - Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SSM Health Good Samaritan","city":"Mount Vernon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Ottawa Clinic","city":"Ottawa","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Pekin","city":"Pekin","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peoria","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peru","city":"Peru","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois University School of Medicine","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare - Washington","city":"Washington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Ankeny Clinic","city":"Ankeny","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Anthony Regional Hospital","city":"Carroll","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians' Clinic of Iowa PC","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates at Mercy Medical Center","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - West Des Moines Clinic","city":"Clive","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iowa Methodist Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Des Moines Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broadlawns Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center - Des Moines","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Laurel Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Healthcare Mission Cancer and Blood - Fort Dodge","city":"Fort Dodge","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Joseph Hospital East","city":"Lexington","state":"Kentucky","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Louisiana Hematology Oncology Associates LLC","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Bird Perkins Cancer Center","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MBP Cancer Center - Baton Rouge General","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Terrebonne General Medical Center","city":"Houma","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Saint Joseph Mercy Hospital Ann Arbor","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health IHA Medical Group Hematology Oncology - Brighton","city":"Brighton","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Medical Center - Brighton","city":"Brighton","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health IHA Medical Group Hematology Oncology - Canton","city":"Canton","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Medical Center - 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Minocqua","city":"Minocqua","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Rice Lake","city":"Rice Lake","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health-Spooner Clinic","city":"Spooner","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-River Region at Stevens Point","city":"Stevens Point","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center at Sturgeon Bay","city":"Sturgeon Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Karen Craver","phone":"336-716-0891","email":"NCORP@wfusm.edu"}],"primaryOutcomes":["Number of Chemotherapy Toxicities (Grade 3 - 5)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["millville-delaware","newark-delaware","rehoboth-beach-delaware","wilmington-delaware","washington-d-c-district-of-columbia","columbus-georgia","bloomington-illinois","canton-illinois","carterville-illinois","chicago-illinois","danville-illinois","decatur-illinois","effingham-illinois","galesburg-illinois","mattoon-illinois","mount-vernon-illinois","normal-illinois","ofallon-illinois","ottawa-illinois","pekin-illinois","peoria-illinois","peru-illinois","springfield-illinois","urbana-illinois","washington-illinois","ankeny-iowa","carroll-iowa","cedar-rapids-iowa","clive-iowa","des-moines-iowa","fort-dodge-iowa","lexington-kentucky","baton-rouge-louisiana","houma-louisiana","ann-arbor-michigan","brighton-michigan","canton-michigan","chelsea-michigan","flint-michigan","iron-mountain-michigan","livonia-michigan","pontiac-michigan","reed-city-michigan","wyoming-michigan","ypsilanti-michigan","bemidji-minnesota","brainerd-minnesota","coon-rapids-minnesota","deer-river-minnesota","detroit-lakes-minnesota","duluth-minnesota","edina-minnesota","hibbing-minnesota","maplewood-minnesota","minneapolis-minnesota","new-ulm-minnesota","park-rapids-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","sandstone-minnesota","shakopee-minnesota","virginia-minnesota","willmar-minnesota","cape-girardeau-missouri","farmington-missouri","rolla-missouri","saint-joseph-missouri","sainte-genevieve-missouri","springfield-missouri","st-louis-missouri","sullivan-missouri","sunset-hills-missouri","charlotte-north-carolina","clemmons-north-carolina","concord-north-carolina","gastonia-north-carolina","wilkesboro-north-carolina","winston-salem-north-carolina","bismarck-north-dakota","fargo-north-dakota","chillicothe-ohio","columbus-ohio","findlay-ohio","mount-vernon-ohio","newark-ohio","portsmouth-ohio","springfield-ohio","zanesville-ohio","danville-pennsylvania","hazleton-pennsylvania","lewisburg-pennsylvania","lewistown-pennsylvania","pottsville-pennsylvania","scranton-pennsylvania","selinsgrove-pennsylvania","state-college-pennsylvania","wilkes-barre-pennsylvania","boiling-springs-south-carolina","easley-south-carolina","gaffney-south-carolina","greenville-south-carolina","greenwood-south-carolina","greer-south-carolina","seneca-south-carolina","spartanburg-south-carolina","union-south-carolina","sioux-falls-south-dakota","ashland-wisconsin","eau-claire-wisconsin","green-bay-wisconsin","marshfield-wisconsin","minocqua-wisconsin","rice-lake-wisconsin","spooner-wisconsin","stevens-point-wisconsin","sturgeon-bay-wisconsin","weston-wisconsin"],"enrichment":{"headline":"Myopenia and Mechanisms of Chemotherapy Toxicity in Older Adults With Colorectal Cancer","inPlainEnglish":"This study will examine the association between low muscle mass (myopenia) at diagnosis and chemotherapy toxicity in older adults with newly diagnosed advanced colorectal cancer.","whoItsFor":["Ages 60 Years to any","Newly diagnosed metastatic CRC or newly recognized metastatic recurrence of CRC \\>= to 3 months (12 weeks) from completion of treatment of non-metastatic CRC","Estimated life expectancy \\>= 6 months","Patients must be able to comprehend English or Spanish (for questionnaire completion)","Patient eligibility is not dependent on body-mass index (BMI) or weight. Patients with a significant (+- \\> 10%) body weight change in the previous 12 months are eligible for this study"],"whoShouldSkip":["Patients enrolled on hospice","Prior systemic chemotherapy for metastatic colorectal cancer (ok if adjuvant chemotherapy completed \\>= 3 months (12 weeks) prior to this disease disease recurrence and treatment)","Patients may not be receiving any other investigational agents. (For clarity, participants on the Alliance A021703 trial are also eligible for this study)","No untreated brain metastases. Patients with treated brain metastases are eligible","Patients on or planned to undergo radiation therapy in near future"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 147 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.088Z"},{"nctId":"NCT04008368","title":"Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease and Falling Donor Myeloid Chimerism Levels","officialTitle":"Repeat Peripheral Blood Stem Cell Transplantation for Patients With Sickle Cell Disease or Beta-Thalassemia and Falling Donor Myeloid Chimerism Levels","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nSickle cell disease can often be treated with blood stem cell transplants. But for some people the disease returns. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.\n\nObjective:\n\nTo cure people s sickle cell disease by giving a second treatment that makes more room in their bone marrow for donor cells.\n\nEligibility:\n\nPeople ages 4 and older with sickle cell disease who had a transplant but the disease returned, and their donor relatives. Donors can be 2 years of age or older.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam, and blood tests.\n\nRecipients will also be screened with heart and breathing tests, x-rays, a bone marrow sample, and teeth and eye exams. They must have a caregiver.\n\nDonors will have 7-8 visits. They will take a drug for 5-6 days to prepare them for the donation. For the donation, blood is taken from a vein in the arm or groin. The stem cells are collected. The rest of the blood is returned. This may be repeated.\n\nRecipients will get a long IV line in their arm or chest for about 1-2 months. They will take drugs to help their body accept the donor cells. They will get the donor cells and red blood cell transfusions through the line. They will stay in the hospital about 30 days after the transfusion of donor cells.\n\nIn first 3 months after the infusion, recipients will have many visits. Then they will have visits every 6 months to 1 year for 5 years. During those visits they will repeat some of the screening tests....","conditions":["Myeloid Chimerism"],"keywords":["Stem Cell Transplant"],"interventions":[{"type":"DEVICE","name":"CliniMACS CD34 Reagent"}],"enrollment":32,"startDate":"2019-10-24","completionDate":"2030-01-30","sex":"ALL","minAge":"2 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion criteria- recipient\n\n1. Patient with history of SCD or beta thalassemia who previously underwent allogeneic hematopoietic stem cell transplantation (HSCT)\n2. Patient with recurrent SCD defined as HbS greater than or equal to 50% for donors with sickle cell trait and greater than or equal to 10% for donors with HbAA with recurrent clinical manifestations (for example but not limited to recurrent painful crises, acute chest syndrome, priapism, or severe anemia) or patients with recurrent beta thalassemia defined as clinical manifestations such as transfusion-dependence or evidence of extramedullary hematopoiesis. The HbS requirement may be waived by the PI or designee for reasons such as the patient is requiring chronic transfusion therapy or otherwise meets clinical criteria for return of SCD.\n3. Persistent donor chimerism levels\n4. Age greater than or equal to 4 years\n5. Negative beta-HCG\n6. Ejection fraction greater than or equal to 35%\n7. DLCO greater than or equal to 35% (Note: This criterion may be omitted in young children (e.g. near the age of 5 years old) or other individuals who may have difficulty understanding or complying with the instructions for accurate testing.)\n\nInclusion- donor\n\nRelated donor from original transplant, deemed suitable and eligible, and willing to donate, per clinical evaluations who are additionally willing to donate blood for research. Related donors will be evaluated in accordance with existing Standard NIH Policies and Procedures for determination of eligibility and suitability for clinical donation. Age \\>= 2 years \\<80 years old\n\nEXCLUSION CRITERIA:\n\nExclusion criteria- recipient\n\n1. ECOG performance status of 3 or more or if \\<16 years of age Lansky score of 50 or lower.\n2. Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to signing the consent\n3. Patients with fever or suspected minor infection should await resolution of symptoms before signing the consent\n4. Major anticipated illness or organ failure incompatible with survival from PBSC transplant\n5. Pregnant or breastfeeding\n6. History of secondary malignancies (other than localized skin cancer)\n7. Donor-specific HLA antibodies with mean fluorescent intensity \\>= 2,000\n\nExclusion- donor\n\nNone","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julia M Varga, R.N.","phone":"(301) 402-3595","email":"julia.varga@nih.gov"},{"name":"Courtney F Joseph, M.D.","phone":"(301) 402-6496","email":"courtney.fitzhugh@nih.gov"}],"primaryOutcomes":["dichotomous positive/negative outcome where a positive response is defined by absence of graft rejection"],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: CliniMACS CD34 Reagent for Myeloid Chimerism","inPlainEnglish":"Background: Sickle cell disease can often be treated with blood stem cell transplants. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.","whoItsFor":["Ages 2 Years to 80 Years","who can join- recipient","Patient with history of SCD or beta thalassemia who previously underwent allogeneic hematopoietic stem cell transplantation (HSCT)","Persistent donor chimerism levels","Age greater than or equal to 4 years","Ejection fraction greater than or equal to 35%","DLCO greater than or equal to 35% (Note: This criterion may be omitted in young children (e.g. near the age of 5 years old) or other individuals who may have difficulty understanding or complying with the instructions for accurate testing.)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are CliniMACS CD34 Reagent. The registry lists allocation as randomized. Background: Sickle cell disease can often be treated with blood stem cell transplants.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.837Z"},{"nctId":"NCT04025541","title":"Analysis of Circulating Tumor Markers in Blood","officialTitle":"Analysis of Circulating Tumor Markers in Blood","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","sponsorClass":"OTHER","summary":"The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process. In the multiplicity of these blood potential biomarkers joins a permanent evolution of the technological means used to detect them/to quantify, as well as to estimate their clinical utility.","conditions":["Cancer","Breast Cancer","Sarcoma","Lung Cancers","Glioma","Colon Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Blood sampling"},{"type":"BIOLOGICAL","name":"Blood sampling C3"},{"type":"BIOLOGICAL","name":"Blood sampling C4/7/10/13"},{"type":"BIOLOGICAL","name":"Blood sampling C5"},{"type":"BIOLOGICAL","name":"Blood sampling C6"},{"type":"BIOLOGICAL","name":"Blood sampling C8"},{"type":"BIOLOGICAL","name":"Blood sampling C9"},{"type":"BIOLOGICAL","name":"Blood sampling C11 + FFPE"},{"type":"BIOLOGICAL","name":"Blood sampling C12"}],"enrollment":992,"startDate":"2018-05-29","completionDate":"2029-05-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,\n2. Man or woman ≥ 18 years,\n3. Obtaining of the informed consent signed before any procedure of specific preselection on approval.\n\nExclusion Criteria:\n\n1. Private persons of freedom or under guardianship,\n2. Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,\n3. Pregnant woman and/or breast-feeding,\n4. Unaffiliated patient to Social Protection System,","locations":[{"facility":"Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICM","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"texier emmannuelle","phone":"0467613102","email":"emmanuelle.texier@icm.unicancer.fr"}],"primaryOutcomes":["Estimation of the feasibility of the various blood tumoral biomarkers analysis"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer"],"drugSlugs":[],"locationSlugs":["montpellier-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Blood sampling for Cancer","inPlainEnglish":"The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades. The potential clinical interests of these circulating biomarkers are diagnostic, prognostic, predictive of the efficiency of targeted therapies (according to the mutational profile of the cancer), and could allow the study of the mechanisms of resistance under process.","whoItsFor":["Ages 18 Years to any","Patient presenting an invasive tumoral pathology (proved or suspected), whatever is the location or the stage,","Man or woman ≥ 18 years,"],"whoShouldSkip":["Private persons of freedom or under guardianship,","Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,","Pregnant woman and/or breast-feeding,","Unaffiliated patient to Social Protection System,"],"whatHappens":"If you join, the listed intervention(s) are Blood sampling, Blood sampling C3, or Blood sampling C4/7/10/13. The registry lists allocation as randomized. The circulating tumoral biomarkers in the blood are the object of numerous researches for several decades.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 992 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.972Z"},{"nctId":"NCT04047628","title":"Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)","officialTitle":"A Multicenter Randomized Controlled Trial of Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Treatment-Resistant Relapsing Multiple Sclerosis (ITN077AI)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"This is a multi-center prospective rater-masked (blinded) randomized controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). Participants will be randomized at a 1 to 1 (1:1) ratio.\n\nAll participants will be followed for 72 months after randomization (Day 0, Visit 0).","conditions":["Relapsing Multiple Sclerosis","Relapsing Remitting Multiple Sclerosis","Secondary Progressive Multiple Sclerosis"],"keywords":["Treatment-Resistant Relapsing Multiple Sclerosis (MS)","Autologous Hematopoietic Stem Cell Transplantation (AHSCT)","Autologous Peripheral Blood Stem Cells (PBMCs) Graft","Best Available Therapy (BAT)","Disease-Modifying Therapy (DMT)","BAT DMT"],"interventions":[{"type":"PROCEDURE","name":"Autologous Hematopoietic Stem Cell Transplantation"},{"type":"BIOLOGICAL","name":"Best Available Therapy (BAT)"}],"enrollment":156,"startDate":"2020-08-17","completionDate":"2030-08-06","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 to 55 years, inclusive, at the time of the screening Visit -2.\n2. Diagnosis of MS according to the 2017 McDonald Criteria139.\n3. EDSS ≤ 6.0 at the time of randomization (Day 0).\n4. T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator.\n5. Highly active treatment-resistant relapsing MS, defined as ≥ 2 episodes of disease activity in the 36 months prior to the screening visit (Visit -2). The two disease activity episodes will be a clinical MS relapse or MRI evidence of MS disease activity and must meet all the criteria described below:\n\n   1. At least one episode of disease activity must occur following ≥ 1 month of treatment with one of the following: (i) an oral DMT approved by the FDA for the treatment of relapsing MS, or (ii) a monoclonal antibody approved by the FDA for the treatment of relapsing MS, or (iii) rituximab. Qualifying DMTs include: dimethyl fumarate, diroximel fumarate, monomethyl fumarate, teriflunomide, cladribine, daclizumab, ponesimod, siponimod, ozanimod, fingolimod, rituximab, ocrelizumab, natalizumab, alemtuzumab, ublituximab, and ofatumumab, and\n   2. At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and\n   3. At least one episode of disease activity must be a clinical MS relapse (see item c.i. below). The other episode(s) must occur at least one month before or after the onset of the clinical MS relapse, and must be either another clinical MS relapse or MRI evidence of disease activity (see item c.ii. below):\n\n   i. Clinical MS relapse must be confirmed by a neurologist's assessment and documented contemporaneously in the medical record. If the clinical MS relapse is not documented in the medical record, it must be approved by the study adjudication committee (see Section 3.5), and ii. MRI evidence of disease activity must include ≥ 1 unique active lesion on one or more brain or spinal cord MRIs. Detailed MRI reports or MRI images must be available for review by the site neurology investigator. A unique active lesion is defined as either of the following:\n\n1\\. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2).\n\n6\\. Candidacy for treatment with at least one of the following high efficacy BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:\n\n1. No prior disease activity episode, as defined in Inclusion Criterion #5, with the candidate BAT DMT, and\n2. No contraindication to the candidate BAT DMT, and\n3. No treatment with the candidate BAT DMT in the 12 months prior to screening.\n\n   7\\. Completion of COVID-19 vaccination series, according to the current Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommendations, ≥ 14 days prior to randomization (Day 0).\n\n   8\\. Positive for VZV antibodies, or completion of at least one dose of the varicella zoster glycoprotein E (gE) Shingrix vaccine at least 4 weeks prior to randomization (Day 0).\n\n   9\\. Insurance approval for MS treatment with at least one candidate BAT DMT (see Inclusion Criterion #6).\n\n   10\\. Ability to comply with study procedures and provide informed consent, in the opinion of the investigator.\n\n   11\\. Females of childbearing potential (defined in Section 5.4.3.1) and males with female partners of childbearing potential are required to adhere to the contraception provisions of Section 5.4.3.1.\n\n   12\\. For participants who use medicinal or recreational marijuana, willingness to substitute MARINOL® if randomized to AHSCT (Section 5.4.2.6).\n\nExclusion Criteria:\n\n1. Diagnosis of primary progressive MS according to the 2017 McDonald criteria.\n2. History of neuromyelitis optica spectrum disorder or MOG antibody disease.\n3. Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational.\n4. Either of the following within one month prior to randomization (Day 0):\n\n   1. Onset of acute MS relapse, or\n   2. Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent.\n5. Initiation of any BAT DMT (see Section 5.2.1) between Visit -2 and randomization (Day 0).\n6. Brain MRI or cerebrospinal fluid (CSF) examination indicating a diagnosis of progressive multifocal leukoencephalopathy (PML).\n7. History of cytopenia consistent with the diagnosis of myelodysplastic syndrome (MDS).\n8. Presence of unexplained cytopenia, polycythemia, thrombocythemia or leukocytosis.\n9. History of sickle cell anemia or other hemoglobinopathy.\n10. Evidence of past or current hepatitis B or hepatitis C infection, including treated hepatitis B or hepatitis C. Hepatitis B surface antibody following hepatitis B immunization is not considered to be evidence of past infection.\n11. Presence or history of mild to severe cirrhosis.\n12. Hepatic disease with the presence of either of the following:\n\n    1. Total bilirubin ≥ 1.5 times the upper limit of normal (ULN) or total bilirubin ≥ 3.0 times the ULN in the presence of Gilbert's syndrome, or\n    2. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 2.0 times the ULN.\n13. Positive COVID-19 PCR test, or alternative nucleic acid amplification test (NAAT) per institutional standards, within 14 days prior to randomization (Day 0).\n14. Evidence of HIV infection.\n15. Positive QuantiFERON - TB Gold,TB Gold Plus, or T-SPOT®.TB test results. PPD tuberculin test may be substituted for QuantiFERON - TB Gold, TB Gold Plus, or T-SPOT®.TB test.\n16. Active viral, bacterial, endoparasitic, or opportunistic infections.\n17. Active invasive fungal infection.\n18. Hospitalization for treatment of infections or parenteral (IV or IM) antibacterials, antivirals, antifungals, or antiparasitic agents within the 30 days prior to randomization (Day 0) unless clearance is obtained from an Infectious Disease specialist.\n19. Receipt of live or live-attenuated vaccines within 6 weeks of randomization (Day 0).\n20. Presence or history of clinically significant cardiac disease including: a. Arrhythmia requiring treatment with any antiarrhythmia therapy, with the exception of low dose beta blocker for intermittent premature ventricular contractions.\n\n    b. Coronary artery disease with a documented diagnosis of either: i. Chronic exertional angina, or ii. Signs or symptoms of congestive heart failure. c. Evidence of heart valve disease, including any of the following: i. Moderate to severe valve stenosis or insufficiency, or ii. Symptomatic mitral valve prolapse, or iii. Presence of prosthetic mitral or aortic valve.\n21. Left ventricular ejection fraction (LVEF) \\< 50%.\n22. Impaired renal function defined as eGFR \\< 60 mL/min/1.73 m2, according to the CKD-EPI formula144.\n23. Forced expiratory volume in one second (FEV1) \\< 70% predicted (no bronchodilator).\n24. Diffusing capacity of the lungs for carbon monoxide (DLCO) (corrected for Hgb) \\< 70% predicted.\n25. Poorly controlled diabetes mellitus, defined as HbA1c \\> 8%.\n26. History of malignancy, except adequately treated localized basal cell or squamous skin cancer, or carcinoma in situ of the cervix. Malignancies for which the participant is judged to be cured will be considered on an individual basis by the study adjudication committee (see Section 3.5).\n27. Presence or history of any moderate to severe rheumatologic autoimmune disease requiring treatment, including but not limited to the following: systemic lupus erythematous, systemic sclerosis, rheumatoid arthritis, Sjogren's syndrome, polymyositis, dermatomyositis, mixed connective tissue disease, polymyalgia rheumatica, polychondritis, sarcoidosis, vasculitis syndromes, or unspecified collagen vascular disease.\n28. Presence of active peptic ulcer disease, defined as endoscopic or radiologic diagnosis of gastric or duodenal ulcer.\n29. Prior history of AHSCT.\n30. Prior history of solid organ transplantation.\n31. Positive pregnancy test or breastfeeding.\n32. Failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.\n33. Psychiatric illness, mental deficiency, or cognitive dysfunction severe enough to interfere with compliance or informed consent.\n34. History of hypersensitivity to rabbit or Escherichia coli-derived proteins.\n35. Any metallic material or electronic device in the body, or other condition that precludes the participant from undergoing MRI with gadolinium administration, as determined by the site radiologist.\n36. Presence or history of ischemic cerebrovascular disorders, including but not limited to transient ischemic attack, subarachnoid hemorrhage, cerebral thrombosis, cerebral embolism, or cerebral hemorrhage.\n37. Presence or history of other neurological disorders, including but not limited to CNS or spinal cord tumor; metabolic or infectious cause of myelopathy; genetically-inherited progressive CNS disorder; CNS sarcoidosis; or systemic autoimmune disorders potentially causing progressive neurologic disease or affecting ability to perform the study assessments.\n38. Presence of any medical comorbidity that the investigator determines will significantly increase the risk of treatment mortality.\n39. Presence of any other concomitant medical condition that the investigator deems incompatible with trial participation.","locations":[{"facility":"Stanford Multiple Sclerosis Center","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Multiple Sclerosis Center, University of Colorado School of Medicine","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Massachusetts Memorial Medical Center","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Neuroscience Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota Multiple Sclerosis Center","city":"Minneapolis","state":"Minnesota","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John L. Trotter Multiple Sclerosis Center, Washington University School of Medicine in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Siinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Multiple Sclerosis Center, University of Rochester","city":"Rochester","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati (UC) Waddell Center for Multiple Sclerosis","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mellen Center for Multiple Sclerosis Treatment and Research, Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multiple Sclerosis Center, Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Comprehensive MS Center, Hospital of the University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center: Division of Multiple Sclerosis and Neuroimmunology","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maxine Mesigner Multiple Sclerosis Comprehensive Care Center, Baylor College of Medicine Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University Multiple Sclerosis Treatment and Research Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Division, Fred Hutchinson Cancer Research Center","city":"Seattle","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Multiple Sclerosis Center, Swedish Neuroscience Institute","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multiple Sclerosis Center at Northwest Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Multiple Sclerosis (MS) Relapse-Free Survival"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["palo-alto-california","aurora-colorado","evanston-illinois","worcester-massachusetts","detroit-michigan","minneapolis-minnesota","rochester-minnesota","st-louis-missouri","new-york-new-york","rochester-new-york","durham-north-carolina","cincinnati-ohio","cleveland-ohio","portland-oregon","philadelphia-pennsylvania","dallas-texas","houston-texas","charlottesville-virginia","richmond-virginia","seattle-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 3: testing Best Available Therapy (BAT) for Relapsing Multiple Sclerosis","inPlainEnglish":"This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS). you would be randomly assigned at a 1 to 1 (1:1) ratio.","whoItsFor":["Ages 18 Years to 55 Years","Age 18 to 55 years, inclusive, at the time of the screening Visit -2","Diagnosis of MS according to the 2017 McDonald Criteria139","EDSS ≤ 6.0 at the time of randomization (Day 0)","T2 abnormalities on brain MRI that fulfill the 2017 McDonald MRI criteria for dissemination in space139. A detailed MRI report or MRI images must be available for review by the site neurology investigator","At least one episode of disease activity must have occurred within the 12 months prior to the screening visit (Visit -2), and","1\\. A gadolinium-enhancing lesion, or 2. A new non-enhancing T2 lesion compared to a reference scan obtained not more than 36 months prior to the screening visit (Visit -2)","6\\. Candidacy for treatment with at least one of the following high how well it works BAT DMTs: cladribine, natalizumab, alemtuzumab, ocrelizumab, ofatumumab, ublituximab and rituximab. Candidacy for treatment for each BAT DMT is defined as meeting all of the following:"],"whoShouldSkip":["Diagnosis of primary progressive MS according to the 2017 McDonald criteria","History of neuromyelitis optica spectrum disorder or MOG antibody disease","Prior treatment with an investigational agent within 3 months or 5 half-lives, whichever is longer. Agents authorized by the FDA for prevention or treatment of COVID-19 are not considered investigational","Either of the following within one month prior to randomization (Day 0):","Onset of acute MS relapse, or","Treatment with intravenous methylprednisolone 1000 mg/day for 3 days or equivalent","Initiation of any BAT DMT (see Section 5.2.1) between Visit -2 and randomization (Day 0)"],"whatHappens":"If you join, the listed intervention(s) are Autologous Hematopoietic Stem Cell Transplantation, or Best Available Therapy (BAT). The registry lists allocation as randomized. This is a multi-center prospective rater-masked (blinded) randomly assigned controlled trial of 156 participants, comparing the treatment strategy of Autologous Hematopoietic Stem Cell Transplantation (AHSCT) to the treatment strategy of Best Available Therapy (BAT) for treatment-resistant relapsing multiple sclerosis (MS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 156 people at 23 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.991Z"},{"nctId":"NCT04099966","title":"AlloSCT for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion","officialTitle":"Allogeneic Stem Cell Transplantation for Malignant and Non-malignant Hematologic Diseases Utilizing Alpha/Beta T Cell and CD19+ B Cell Depletion - NYMC 588","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Mitchell Cairo","sponsorClass":"OTHER","summary":"Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion. All other treatment is standard of care.","conditions":["Acute Leukemia","Severe Aplastic Anemia","Non-hodgkin Lymphoma","Hodgkin Lymphoma","Kostmann","Diamond Blackfan Anemia","Amegakaryocytic Thrombocytopenia","Sickle Cell Disease","Beta-Thalassemia"],"keywords":["allogeneic stem cell transplantation","t-cell depletion","alpha beta cell depletion"],"interventions":[{"type":"DRUG","name":"alpha beta depletion"}],"enrollment":20,"startDate":"2021-04-01","completionDate":"2026-12-31","sex":"ALL","minAge":"1 Day","maxAge":"30 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ALL:ALL high risk including one or more of the following: (t(9;22) or 11q23 chromosomal abnormality, primary induction failure (\\<15% blasts at time of registration), mixed phenotype acute leukemia (MPAL), persistent MRD (\\<0.01% by flow or persistent abnormal karyotype detected by cytogenetics) or hypodiploidy (44 chromosomes)) in first remission ' ALL in second remission and beyond;\n2. AML: History of AML induction/reinduction Failure (\\<15% blasts at time of registration); AML in CR1 with poor cytogenetics (i.e. 12p, 5a, -7, FLT3 mutation/duplication, t(9;11) and others); AML with persistent minimal residual disease (MRD) in CR1(\\<0.01% on flow or persistent abnormal karyotype detected by cytogenetics); AML CR2 or beyond; AML in refractory relapse but ≤15% bone marrow leukemia blasts; Therapy-related AML\n3. High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission\n\n5\\. Bone marrow failure syndromes: Kostmann syndrome refractory or intolerant to granulocyte colony-33stimulating factor; Diamond-Blackfan anemia refractory or intolerant to corticosteroids and/or cyclosporine'; amegakaryocytic thrombocytopenia 6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease) 7. age 0-30 years 8. adequate organ function\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast-feeding are not eligible.\n2. Patients with documented uncontrolled infection at the time of study entry are not eligible.\n3. Karnofsky/Lansky (age appropriate) Performance Score \\<60\n4. Demonstrated lack of compliance with medical care\n5. Patients who have received allogeneic HSCT within 6 months, unless being done as a boost.\n6. Patients with active \\<Grade 2 GVHD.","locations":[{"facility":"New York Medical College","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mitchell S Cairo, MD","phone":"9145942150","email":"mitchell_cairo@nymc.edu"},{"name":"Lauren Harrison, RN","phone":"6172857844","email":"lauren_harrison@nymc.edu"}],"primaryOutcomes":["incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","sickle-cell"],"drugSlugs":[],"locationSlugs":["valhalla-new-york"],"enrichment":{"headline":"Phase 2: testing alpha beta depletion for Acute Leukemia","inPlainEnglish":"Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion.","whoItsFor":["Ages 1 Day to 30 Years","High Risk Myelodysplastic syndrome (MDS) 4 Lymphoma: Hodgkin (HL) or Non-Hodgkin (NHL): HL or NHL in induction failure; HL or NHL in PR1 or PR2 ; HL or NHL in CR2 or subsequent remission"],"whoShouldSkip":["Females who are pregnant or breast-feeding are not eligible","Patients with documented uncontrolled infection at the time of study entry are not eligible","Karnofsky/Lansky (age appropriate) Performance Score \\<60","Demonstrated lack of compliance with medical care","Patients who have received allogeneic HSCT within 6 months, unless being done as a boost","Patients with active \\<Grade 2 GVHD"],"whatHappens":"If you join, the listed intervention(s) are alpha beta depletion. The registry lists allocation as na. Children, adolescents, and young adults with malignant and non-malignant conditionsundergoing an allogeneic stem cell transplantation (AlloSCT) will have the stem cells selected utilizing α/β CD3+/CD19+ cell depletion.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Valhalla. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.837Z"},{"nctId":"NCT04106830","title":"Clinical and Imaging Cohort of Neuroinflammation Diseases in China (CLUE)","officialTitle":"Prospective Cohort Study of cLinical and Imaging Patterns of neUroinflammation disEases (CLUE)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Beijing Tiantan Hospital","sponsorClass":"OTHER","summary":"CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI. In addition, participants will receive a one-time baseline examination including T1WI, T2WI, FLAIR, and SWI sequences on 7T MRI, as well as PET-MRI.","conditions":["NMO Spectrum Disorder","MRI","Multiple Sclerosis","MOGAD"],"keywords":[],"interventions":[{"type":"DRUG","name":"Intravenous steroid"}],"enrollment":1000,"startDate":"2019-01-01","completionDate":"2027-12-31","sex":"ALL","minAge":"16 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 16-75\n* Diagnosis of neuroinflammatory and demyelination disease\n* Availability of demographic and clinical data at the time disease onset\n* Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years.\n\nExclusion Criteria:\n\n* Patients for whom MRI is contra-indicated\n* Patients included in an ongoing clinical trial where the product is blinded","locations":[{"facility":"Beijing Tiantan Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yaou Liu, PhD","phone":"+86 1059975396","email":"yaouliu80@163.com"}],"primaryOutcomes":["The brain structural change over time between the baseline MRI and the follow-up MRIs","The spinal cord change over time between the baseline MRI and the follow-up MRIs.","The functional change over time between the baseline MRI and the follow-up MRIs."],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Intravenous steroid for NMO Spectrum Disorder","inPlainEnglish":"CLUE is a prospective study to assess structural and functional changes of the brain, spinal cord, and optic nerve, as well as the inflammatory environment in patients with neuroinflammatory and demyelinating diseases. Participants will receive magnetic resonance (MR) techniques including DIR, DKI, QSM, Rs-fMRI, conventional sequences (T1WI/T2WI/FLAIR), and the MR metabolic SPICE sequence, and will be followed up for one year using 3T MRI.","whoItsFor":["Ages 16 Years to 75 Years","Diagnosis of neuroinflammatory and demyelination disease","Availability of demographic and clinical data at the time disease onset","Informed written consent obtained from the patient, and/or patient's parent(s), and/or legal representative. Assent, if old enough to grant, will be obtained from all patients under the age of 16 years"],"whoShouldSkip":["Patients for whom MRI is contra-indicated","Patients included in an ongoing clinical trial where the product is blinded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.993Z"},{"nctId":"NCT04135807","title":"Implantable Microdevice In Primary Brain Tumors","officialTitle":"A Pilot Study of an Implantable Microdevice for In Situ Evaluation of Drug Response in Patients With Primary Brain Tumors","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Oliver Jonas","sponsorClass":"OTHER","summary":"This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors.\n\n* The device involved in this study is called a microdevice.\n* The drugs used in this study will only include drugs already used systemically for the treatment of gliomas.","conditions":["Grade II Glioma","Grade III Glioma","Grade IV Glioma","Astrocytoma","Oligodendroglioma of Brain","Anaplastic Astrocytoma of Brain","Anaplastic Oligodendroglioma","Glioblastoma"],"keywords":["Grade II Glioma","Grade III Glioma","Grade IV Glioma","Astrocytoma","Oligodendroglioma of Brain","Anaplastic Astrocytoma of Brain","Glioblastoma"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Microdevice"}],"enrollment":30,"startDate":"2020-03-03","completionDate":"2028-01-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have operable supratentorial tumor presumed to be WHO grade II-IV glioma (Astrocytoma, Oligodendroglioma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, or Glioblastoma) based on radiological evidence at MRI, where a gross total or partial surgical resection is intended.\n* Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries/biopsies.\n* Participants must be 18 years of age or older.\n* Karnofsky Performance Score ≥ 60 (Appendix C).\n* Participants must have normal organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000/mcL\n  * Absolute neutrophil count ≥ 1,500/mcL\n  * Platelets ≥ 100,000/mcL\n  * Total bilirubin within normal institutional limits\n  * AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal\n  * Creatinine within normal institutional limits OR\n  * Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.\n* Participants must be evaluated by a neurosurgeon who will determine the feasibility of microdevice implantation based on clinical history, extent, and anatomical location of the tumor.\n* Because participants will be exposed to microdoses of therapeutic agents only in a localized setting and for a short period of time (2-4 hours), the risk of interaction with other drugs routinely assumed by participants is considered not applicable. Thus, participants receiving any medications or substances that are inhibitors or inducers of CYP450 enzymes remain eligible.\n* The effects of the microdevice on the developing human fetus are unknown. For this reason and because the therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential must agree to have a negative serum pregnancy test within 48 hours prior to registration. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of study participation.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n* Participants who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant women are excluded from this study because agents released by the microdevice have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents used in this study, breastfeeding should be discontinued if the mother is treated in the study for a total of 14 days after removal of the microdevice.\n* Tumor size \\< 5 cm3.\n* Tumor located in deep brain structures (e.g. thalamus, brainstem).\n* Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures.\n* If there are significant risk factors (e.g. high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines, patients will be excluded from the trial.","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pier Paolo Peruzzi, MD, PhD","phone":"617-732-6600","email":"PPERUZZI@PARTNERS.ORG"}],"primaryOutcomes":["Success Rate of Microdevice Retrieval","Number of Participants with Microdevice Related Adverse Events as Assessed by CTCAE Volume 5.0"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Early phase 1: Microdevice for Grade II Glioma","inPlainEnglish":"This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. * The device involved in this study is called a microdevice.","whoItsFor":["Ages 18 Years to any","Histological confirmation of WHO grade II-IV glioma at time of intraoperative frozen analysis (for newly diagnosed tumors). This is not necessary in cases where a histopathologic diagnosis is already available from prior surgeries/biopsies","Participants must be 18 years of age or older","Karnofsky Performance Score ≥ 60 (Appendix C)","Participants must have normal organ and marrow function as defined below:","Leukocytes ≥ 3,000/mcL","Absolute neutrophil count ≥ 1,500/mcL","Platelets ≥ 100,000/mcL"],"whoShouldSkip":["Participants who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas) prior to entering the study or those who have not recovered from side effects due to agents administered more than 4 weeks earlier","Participants who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to the microdevice or any agents used in the study","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements","Tumor size \\< 5 cm3","Tumor located in deep brain structures (e.g. thalamus, brainstem)","Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical procedures"],"whatHappens":"If you join, the listed intervention(s) are Microdevice. The registry lists allocation as na. This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.679Z"},{"nctId":"NCT04165772","title":"Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","officialTitle":"A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.","conditions":["Rectal Adenocarcinoma","Clinical Stage: Stage II (T3-4, N-)","Stage III (Any T, N+)","Solid Tumor","Solid Tumor, Adult","Endometrial Cancer"],"keywords":["PD1 blockade","TSR-042","Radiation","Capecitabine","5-FU","19-288","Solid tumor","Dostarlimab","endometrial cancer"],"interventions":[{"type":"DRUG","name":"TSR-042 or Dostarlimab"},{"type":"DRUG","name":"capecitabine or 5-FU"},{"type":"RADIATION","name":"Intensity Modulated Radiation Therapy (IMRT)"}],"enrollment":212,"startDate":"2019-12-11","completionDate":"2026-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to provide written informed consent for the trial.\n* Be ≥18 years of age on the date of signing informed consent.\n* ECOG performance status of 0 or 1.\n* Histologically confirmed locally advanced solid tumor (Cohorts 1 \\& 2)\n* Histologically confirmed endometrial cancer (Cohort 3)\n* Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \\& 2)\n* Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3).\n* No evidence of distant metastases.\n\n  * Radiologically measurable or clinically evaluable disease\n* Tumor specimen that demonstrates mismatch repair deficiency by Immunohistochemistry or microsatellite instability as demonstrated by NGS or PCR.\n* Negative pregnancy test done 72 hours prior to beginning treatment, for women of childbearing potential only. Subjects of childbearing potential must be willing to use an adequate method of contraception. Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom). Contraception, for the course of the study starting with the first dose of study medication through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.\n\n  1. For Cohort 3, the use of a combination estrogen/progesterone contraceptive is allowed; the use of progesterone-only methods including hormone (progestin) releasing IUD, depot medroxyprogesterone acetate, and progestin-only birth control pills is not allowed.\n\nNonchildbearing potential is defined as follows (by other than medical reasons):\n\n* ≥45 years of age and has not had menses for \\>1 year\n* Patients who have been amenorrhoeic for \\<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation\n* Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.\n\n  * Participant receiving corticosteroids may continue if their dose is stable for least 4 weeks prior to initiating protocol therapy.\n  * Has QTcF ≤ 450 msec, or ≤ 480 msec for participants with bundle branch block.\n  * Demonstrate adequate organ function as defined below within 14 days of Cycle 1, Day 1, all screening labs should be performed within 14 days of treatment initiation.\n  * Hematological\n* Absolute neutrophil count (ANC) ≥1,500 /mcL\n* Platelets ≥100,000 / mcL\n* Hemoglobin \\>9 g/dL or ≥5.6 mmol/L\n\n  * Renal\n* Serum creatinine OR Measured or calculated(a) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥60 mL/min for subject with creatinine levels \\> 1.5 × institutional ULN\n\n  * Hepatic\n* Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN\n\n  * Coagulation\n* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants ≤1.5 × ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended (a) Creatinine clearance should be calculated per institutional standard.\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease\n* Prior radiation therapy, chemotherapy, or surgery for tumor\n\n  a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and/or endometrial cancer. Hormonal therapy must be discontinued at least 1-week prior to first dose of study treatment (dostarlimab).\n* For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible).\n* Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma.\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment.\n* Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses.\n* Active infection requiring systemic therapy.\n* Cohort 1 \\& 3: Received prior therapy with an antibody or drug specifically targeting T- cell co-stimulation or checkpoint pathways.\n* Experienced ≥ Grade 3 immune-related AE with prior immunotherapy, except for non-clinically significant lab abnormalities.\n* Other Anticancer or Experimental Therapy. No other experimental therapies (including chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, matrix metalloprotease inhibitors, thalidomide, anti-VEGF/Flk-1 monoclonal antibody or other experimental drugs) of any kind are permitted while the patient is receiving study treatment.\n* Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)\n* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Women who are pregnant or breastfeeding, or men expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening visit through 150 days after the last dose of study medication.\n* Concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into the study. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.\n* Received a live vaccine within 30 days of planned start of study medication.\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to enrollment.\n\n  a. NOTE: For Cohort 3: endometrial sampling (e.g., biopsies, dilatation and curettage), is NOT considered major surgical procedure.\n* History of interstitial lung disease.\n* Known hypersensitivity to TSR-042 components or excipients.","locations":[{"facility":"Hartford Healthcare (Data Collection)","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Alliance MCI (Data Collection Only)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Basking Ridge - Limited Protocol Activities","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth - Limited Protocol Activities","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen - Limited Protocol Activities","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Commack - Limited Protocol Activities","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester - Limited Protocol Activities","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau - Limited Protocol Activities","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lehigh Valley Health Network (Data Collection Only)","city":"Allentown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrea Cercek, MD","phone":"646-888-4189","email":"cerceka@mskcc.org"},{"name":"Neil Segal, MD, PhD","phone":"646-888-4187","email":""}],"primaryOutcomes":["Pathologic complete response (pCR) or complete clinical response (cCR) at 12 months"],"hasResults":false,"conditionSlugs":["endometrial-cancer","als"],"drugSlugs":[],"locationSlugs":["hartford-connecticut","miami-florida","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","allentown-pennsylvania"],"enrichment":{"headline":"Phase 2: testing TSR-042 or Dostarlimab for Rectal Adenocarcinoma","inPlainEnglish":"This study wants to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors. The study will also look at the safety of the study drug.","whoItsFor":["Ages 18 Years to any","how well you can do daily activities (ECOG score) of 0 or 1","Histologically confirmed locally advanced solid tumor (Cohorts 1 \\& 2)","Histologically confirmed endometrial cancer (Cohort 3)","Solid tumors that in standard practice would be treated with neoadjuvant therapy or surgery (depending on tumor type) (Cohorts 1 \\& 2)","Endometrial cancer that is clinically FIGO 2009 Stage I or II (Cohort 3)","No evidence of distant metastases","Radiologically measurable or clinically evaluable disease"],"whoShouldSkip":["Presence of metastatic or recurrent disease","Prior radiation therapy, chemotherapy, or surgery for tumor","a. NOTE: For Cohort 3, patients are allowed to have received prior hormonal therapy for treatment of endometrial hyperplasia and/or endometrial cancer. Hormonal therapy must be discontinued at least 1-week prior to first dose of study treatment (dostarlimab)","For patients with colorectal primary -Tumor is causing symptomatic bowel obstruction (patients who have a temporary diverting ostomy are eligible)","Cohort 1 Only: Other invasive malignancy ≤ 5 years prior to registration. Exceptions are non-melanoma skin cancer that has undergone potentially curative therapy and in situ cervical carcinoma","Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of non- physiologic dose immunosuppressive therapy within 7 days prior to first dose of trial treatment","Active autoimmune disease requiring systemic treatment within the past 2 years or documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents at non-physiologic doses"],"whatHappens":"If you join, the listed intervention(s) are TSR-042 or Dostarlimab, capecitabine or 5-FU, or Intensity Modulated Radiation Therapy (IMRT). The registry lists allocation as randomized. This study wants to find out whether the study drug, TSR-042, followed by standard chemoradiotherapy (the chemotherapy drug capecitabine + radiation therapy) and standard surgery is an effective treatment for advanced dMMR solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 212 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.699Z"},{"nctId":"NCT04181060","title":"Osimertinib With or Without Bevacizumab as Initial Treatment for Patients With EGFR-Mutant Lung Cancer","officialTitle":"Randomized Phase III Study of Combination Osimertinib (AZD9291) and Bevacizumab Versus Osimertinib (AZD9291) Alone as First-Line Treatment for Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the effect of bevacizumab and osimertinib combination vs. osimertinib alone for the treatment of non-small cell lung cancer that has spread outside of the lungs (stage IIIB-IV) and has a change (mutation) in a gene called EGFR. The EGFR protein is involved in cell signaling pathways that control cell division and survival. Sometimes, mutations in the EGFR gene cause EGFR proteins to be made in higher than normal amounts on some types of cancer cells. This causes cancer cells to divide more rapidly. Osimertinib may stop the growth of tumor cells by blocking EGFR that is needed for cell growth in this type of cancer. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving osimertinib with bevacizumab may control cancer for longer and help patients live longer as compared to osimertinib alone.","conditions":["Advanced Lung Non-Squamous Non-Small Cell Carcinoma","Metastatic Lung Non-Squamous Non-Small Cell Carcinoma","Recurrent Lung Non-Squamous Non-Small Cell Carcinoma","Stage IIIB Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":300,"startDate":"2020-12-28","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must have a pathologically-confirmed diagnosis of non-squamous, non-small cell lung cancer (NSCLC)\n* Patient must have advanced disease, defined as - either stage IV disease, stage IIIB disease not amenable to definitive multi-modality therapy, or recurrent disease after a prior diagnosis of stage I-III disease. All staging is via the American Joint Committee on Cancer (AJCC)/International Association for the Study of Lung Cancer (IASLC) 8th edition staging criteria\n* Patient must have somatic activating sensitizing mutation in EGFR (e.g. but not limited to Exon 19 deletion, L858R, E709X, G719X, exon 19 insertions, L861Q, S768I). Patients with non-sensitizing mutations in EGFR (EGFR exon 20 insertions) are not eligible. Test results originating from a Clinical Laboratory Improvement Act (CLIA)-certified or similarly accredited laboratory are acceptable; no specific assay is mandated. Plasma, cytology, or tumor tissue can be utilized for mutation testing\n* Patient must not have received any prior treatment with an anti-VEGF agent\n\n  * NOTE: Prior treatment with an EGFR TKI is not allowed, however if a candidate for this study has already started osimertinib within 21 days prior to randomization, the exact osimertinib start date is known, and the patient had the required study baseline imaging completed prior to the osimertinib start date, the patient will be eligible\n* Patients that have received prior radiation therapy are eligible. Radiation (limited field stereotactic radiation or conventional radiation) must have been completed at least one week prior to study drug initiation and more extensive field radiation (i.e., whole-brain radiotherapy \\[WBRT\\]) must have been completed at least two weeks prior to drug initiation\n* Patient must not have any risk factors for anti-VEGF administration, specifically, hemoptysis, active cardiovascular disease, uncontrolled hypertension, significant proteinuria (screening urinalysis \\> 300 mg/dl) and tumor invading major blood vessels\n* Patient must have measurable disease. Baseline measurements of sites of disease must be obtained within 4 weeks prior to study randomization. If a potential target lesion is previously irradiated without subsequent growth and/or is radiated after the imaging from which baseline measurements are obtained, they cannot be included as target lesions, and additional target lesions are required to meet criteria for measurable disease\n* Patient must not have had any prior systemic treatment for metastatic disease\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n* All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy\n* A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for 2 weeks prior to the start of treatment, while on study treatment, and for\n\n  * 6 weeks after the last dose of protocol treatment for female patients on the osimertinib (AZD9291) alone arm\n  * 4 months after the last dose of protocol treatment for male patients on osimertinib (AZD9291) alone arm\n  * 6 months after the last dose of protocol treatment for all patients on osimertinib (AZD9291) plus bevacizumab combination arm\n  * NOTE: Female patients should also not breastfeed while on treatment and for 6 months after the last dose bevacizumab\n* Leukocytes \\>= 3,000/mcL (obtained =\\< 14 days prior to randomization)\n* Absolute neutrophil count \\>= 1,500/mcL (obtained =\\< 14 days prior to randomization)\n* Platelets \\>= 100,000/mcL (obtained =\\< 14 days prior to randomization)\n* Hemoglobin \\>= 9 g/dL (obtained =\\< 14 days prior to randomization)\n* Total bilirubin and creatinine =\\< 1.5 x institutional upper limit of normal (ULN) (obtained =\\< 14 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN (obtained =\\< 14 days prior to randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if neurologically stable without glucocorticoid therapy after the stated washout period from radiation therapy (RT) or surgery provided the metastatic lesions are non-hemorrhagic\n* Patients with untreated brain metastases or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required provided the metastatic lesions are non-hemorrhagic and are neurologically stable without glucocorticoid therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have the ability to understand and the willingness to sign a written informed consent document and comply with study requirements\n* Patient must not have had treatment with any investigational drug within five half-lives or 3 months (whichever is greater), prior to study initiation\n* Patient must not be currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. For any patient currently receiving such inducers of CYP3A4, they must discontinue use prior to first dose of study treatment. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4\n* Patient must not have any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of randomization, with the exception of alopecia and grade 2 prior platinum-therapy-related neuropathy\n* Patient must not have any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it challenging for the patient to participate in the study. Screening for chronic conditions is not required\n* Patient must not have refractory nausea and vomiting, chronic gastrointestinal diseases, the inability to swallow the osimertinib tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib\n* Patient must not have a medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease\n* Patient must not have a history of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib\n* Patient must not have mean resting corrected QT interval (QTc) \\> 470 msec obtained from 3 electrocardiograms (ECGs), using the screening clinic ECG machine derived QTc value (using Bazett's correction)\n* Patient must not have any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second-degree heart block\n* Patient must not have any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: potassium \\< lower limit of normal \\[LLN\\]; magnesium \\< LLN; calcium \\< LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause torsades de pointes","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery 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The registry lists allocation as randomized. This phase III trial compares the effect of bevacizumab and osimertinib combination vs.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 604 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.673Z"},{"nctId":"NCT04192344","title":"A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABSK-021 in Patients With Advanced Solid Tumor","officialTitle":"A Phase 1, Open-Label Study of ABSK021 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Advanced Solid Tumor","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Abbisko Therapeutics Co, Ltd","sponsorClass":"INDUSTRY","summary":"This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.","conditions":["Neoplasms","Tenosynovial Giant Cell Tumor"],"keywords":["Tenosynovial Giant Cell Tumor","TGCT","Solid tumors"],"interventions":[{"type":"DRUG","name":"ABSK021"}],"enrollment":276,"startDate":"2020-01-20","completionDate":"2031-12-31","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists\n* ECOG (electrocorticogram) performance status 0\\~1\n* Life expectancy ≥ 3 months\n* Adequate organ function and bone marrow function\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. A diagnosis of TGCT \\[i ncluding pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT TS) (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist,and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi disciplinary tumor board);\n2. Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;\n3. Others\n\nFor Adolescent Cohort (China only):\n\n1. Patient and/or legally acceptable representative should understand, sign, and date the written voluntary informed consent form prior to screening.\n2. Adolescents≥ 12 years of age and \\< 18 years at the time of informed consent.\n3. Body weight ≥ 40kg.\n4. A diagnosis of TGCT \\[including pigmented villonodular synovitis (PVNS) or giant cell tumors of the tendon sheath (GCT-TS)\\] (i) that has been histologically confirmed either by local laboratory, and (ii) unresectable, defined as confirmed by assessment by at least two clinical experts (including at least one independent expert who is not part of the trial conduct), meeting one of the following 2 requirements: ①located in a complex anatomical site, is extensively invasive, and cannot be completely resected; ②surgical operation may cause dysfunction or serious complications.\n5. Measurable disease as defined by RECIST v1.1 (with at least 1 lesion ≥ 2 cm is required), assessed by MRI scans in local site prior to dosing.\n6. Others\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors\n* Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment\n* Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication\n* Previous anti-cancer therapy, including chemotherapy, radiotherapy, endocrine therapy or molecular targeted therapy within ≤ 5-halflife or ≤ 4 weeks (whichever is shorter) prior to initiation of study treatment (chemotherapy with nitrosourea or mitomycin should be 6 weeks prior to initiation of study treatment)\n* Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence\n* Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo\n* Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug\n* Concomitant use of strong inhibitors or inducers of CYP3A4\n* Active central nervous system (CNS) metastases\n* Impaired cardiac function or clinically significant cardiac disease\n* Patients with Gilbert's Syndrome or other underlying conditions that may lead to a greater likelihood of developing LFT(liver function test) abnormalities during the study\n* Known human immunodeficiency virus or active hepatitis B, or active hepatitis C infection\n* Refractory/uncontrolled ascites or pleural effusion\n* Pregnant or nursing\n\nFor patients with tenosynovial giant cell tumor (TGCT) :\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product\n2. For expansion part, previous treatment with CSF 1/CSF 1R pathway inhibitors (not applicable for TGCT patients in US）\n3. Others\n\nFor Adolescent Cohort (China only):\n\n1. Known allergy or hypersensitivity to any component of the investigational drug product.\n2. Previous treatment with highly selective inhibitors targeting CSF-1/CSF-1R prior to first dosing. However, patients who have received prior treatment with multi-kinase inhibitors that include the CSF-1/CSF-1R pathway are allowed, such as Imatinib and Nilotinib.\n3. Know additional malignancy that required active treatment and may affect the patient's participation in the study or affect the outcome of the study as assessed by the Investigator. Exceptions include cured basal cell carcinoma of skin, squamous cell carcinoma of skin, and other carcinoma in situ.\n4. Others","locations":[{"facility":"Precision NextGen Oncology","city":"Beverly Hills","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"SCRI at HealthOne","city":"Denver","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Winship Cancer Institute of Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Beijing Jishuitan Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Sun Yat-sen University","city":"Guangdong","state":"Guangzhou","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hebei Medical University Third Hospital","city":"Shijiazhuang","state":"Hebei","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Henan Cancer Hospital","city":"Zhengzhou","state":"Henan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhengzhou Universtity","city":"Zhengzhou","state":"Henan","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Liaoning Cancer Hospital","city":"Shenyang","state":"Liaoning","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Huashan Hospital of Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Shanghai Sixth People's Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Xi'an Hong Hui Hospital","city":"Xian","state":"Shanxi","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"YUAN LU","phone":"+86-21-68910052","email":"clinical@abbisko.cn"},{"name":"Siqing Fu, MD","phone":"(713)792-4318","email":"siqingfu@mdanderson.org"}],"primaryOutcomes":["Incidence of DLTs","Incidence and Severity of AEs"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["beverly-hills-california","denver-colorado","atlanta-georgia","houston-texas","beijing-china","guangdong-china","shijiazhuang-china","zhengzhou-china","nanjing-china","shenyang-china","shanghai-china","xian-china","chengdu-china","hangzhou-china"],"enrichment":{"headline":"Phase 1: testing ABSK021 for Neoplasms","inPlainEnglish":"This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.","whoItsFor":["Ages 12 Years to any","Histologically confirmed solid tumors that have progressed on or intolerant to standard therapy or whom no standard therapy exists","ECOG (electrocorticogram) performance status 0\\~1","Life expectancy ≥ 3 months","Adequate organ function and bone marrow function","For patients with tenosynovial giant cell tumor (TGCT) :","Measurable disease as defined by RECIST 1.1 (except that a minimal size of 2 cm is required), assessed from MRI scans;","For Adolescent Cohort (China only):"],"whoShouldSkip":["Known allergy or hypersensitivity to any component of the investigational drug product Previous treatment with CSF-1(colony stimulating factor 1)/CSF-1R (colony stimulating factor 1 receptor) pathway inhibitors","Known additional malignancy that is progressing or required active treatment within 3 years of the first dose of study treatment","Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication","Major surgery within 4 weeks of the first dose of study drug and all surgical wounds must be healed and free of infection or dehiscence","Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤2 severity (CTCAE v5.0) with the exception of alopecia and vitiligo","Prior corticosteroids as anti-cancer therapy within a minimum of 2 weeks of the first dose of study drug","Concomitant use of strong inhibitors or inducers of CYP3A4"],"whatHappens":"If you join, the listed intervention(s) are ABSK021. The registry lists allocation as na. This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 276 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.970Z"},{"nctId":"NCT04198766","title":"Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","officialTitle":"An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"SINGLE","sponsor":"Inhibrx Biosciences, Inc","sponsorClass":"INDUSTRY","summary":"This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.","conditions":["Solid Tumor","Non-Small Cell Lung Cancer","Head and Neck Cancer","Melanoma","Gastric Cancer","Renal Cell Carcinoma","Urothelial Carcinoma","Resectable Non-Small-Cell Lung Cancer"],"keywords":["Phase 1 and Phase 2","Phase 1 and Phase 2 Clinical Trial","Solid Tumors","Head and Neck Cancer","Lung Cancer","Non-Small Cell Lung Cancer","OX40 receptor agonist","PD-L1 positive","Pembrolizumab","Keytruda","Chemotherapy","Immunotherapy","HNSCC","Oropharyngeal cancer","Hypopharyngeal cancer","Oral cancer","INBRX-106","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Squamous Cell","Head and Neck Neoplasms","Neoplasms by Site","Carcinoma","Carcinoma, Squamous Cell","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents, Immunological","Antineoplastic Agents","Squamous Cell Carcinoma of Head and Neck","NSCLC","Neoadjuvant","Adjuvant"],"interventions":[{"type":"DRUG","name":"INBRX-106 - Hexavalent OX40 agonist antibody"},{"type":"DRUG","name":"pembrolizumab 200 mg"},{"type":"DRUG","name":"pembrolizumab 400 mg"},{"type":"DRUG","name":"Carboplatin AUC-5"},{"type":"DRUG","name":"Carboplatin AUC-6"},{"type":"DRUG","name":"Pemetrexed 500 mg/m2"},{"type":"DRUG","name":"Cisplatin 75mg/m2"},{"type":"DRUG","name":"Paclitaxel 200mg/m2"},{"type":"DRUG","name":"Nab paclitaxel 100mg/m2"},{"type":"DRUG","name":"Gemcitabine (1000 mg/m2)"}],"enrollment":340,"startDate":"2019-12-10","completionDate":"2033-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Select Inclusion Criteria:\n\n* Males or females aged ≥18 years.\n* Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.\n* Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G/GEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.\n* Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.\n* For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen.\n* For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1/L1 in curative (neo-adjuvant/adjuvant) setting is allowed only if completed \\>/= 6 months prior to progression to local recurrence or metastatic disease.\n* For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.\n* All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.\n* PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.\n* Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.\n\nSelect Exclusion Criteria:\n\n* Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.\n* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.\n* Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)\n* Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.\n* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.\n* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.\n* Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n* Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\< 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\< 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\<92% on room air.\n* Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.\n* Major surgery within 4 weeks prior to enrollment on this trial.\n* Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.\n* Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n* Additional in- and exclusion criteria per protocol.","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Oncura Health","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health - Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"California Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials - Colorado","city":"Lakewood","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clermont Oncology Center","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Florida Hematology and Oncology Center","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute - Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Henry Ford Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"HealthPartners Cancer Research Center","city":"Saint Louis Park","state":"Minnesota","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"HealthPartners Cancer Research Center (Regions Hospital)","city":"Saint Paul","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Washington University in St. Louis School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health Cancer Centers of Montana","city":"Billings","state":"Montana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists - Grand Island","city":"Grand Island","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center at Cooper","city":"Camden","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Providence Portland Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Lehigh Valley Health Network","city":"Allentown","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Health Science Center","city":"Knoxville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University School of Medicine","city":"Nashville","state":"Tennessee","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at Mary Crowley","city":"Dallas","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Renovatio Clinical - El Paso","city":"El Paso","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"San Antonio","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Renovatio Clinical","city":"The Woodlands","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center at Tyler","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Froedtert Hospital and the Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Curie Oncology","city":"Singapore","state":"","country":"Singapore","status":"COMPLETED","lat":null,"lon":null},{"facility":"Icon Cancer Centre Farrer Park","city":"Singapore","state":"","country":"Singapore","status":"COMPLETED","lat":null,"lon":null},{"facility":"Icon Cancer Centre Mount Alvernia","city":"Singapore","state":"","country":"Singapore","status":"COMPLETED","lat":null,"lon":null},{"facility":"Inje University College of Medicine","city":"Busan","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chungbuk National University Hospital","city":"Cheongju-si","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, St. Vincent's Hospital","city":"Gyeonggi-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chonnam National University Hwasun Hospital","city":"Hwasun","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Incheon","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHA Bundang Medical Center","city":"Seongnam-si","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hanyang University Seoul Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea Seoul St. Mary's Hospital,","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ajou University Hospital","city":"Suwon","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital (CCH)","city":"Changhua","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"E-Da Cancer Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)","city":"Kaohsiung City","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Study Director - Inhibrx Biosciences, Inc","phone":"858-500-7833","email":"clinicaltrials@inhibrx.com"}],"primaryOutcomes":["Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab","Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab","MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab","Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts","Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC","To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","kidney-cancer","stomach-cancer","head-and-neck-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["duarte-california","glendale-california","la-jolla-california","los-angeles-california","murrieta-california","santa-rosa-california","lakewood-colorado","clermont-florida","orange-city-florida","atlanta-georgia","chicago-illinois","iowa-city-iowa","louisville-kentucky","detroit-michigan","grand-rapids-michigan","saint-louis-park-minnesota","saint-paul-minnesota","st-louis-missouri","billings-montana","grand-island-nebraska","omaha-nebraska","camden-new-jersey","the-bronx-new-york","cleveland-ohio","portland-oregon","allentown-pennsylvania","knoxville-tennessee","nashville-tennessee","dallas-texas","el-paso-texas","san-antonio-texas","the-woodlands-texas","tyler-texas","fairfax-virginia","milwaukee-wisconsin","singapore-singapore","busan-south-korea","cheongju-si-south-korea","gyeonggi-do-south-korea","hwasun-south-korea","incheon-south-korea","seongnam-si-south-korea","seoul-south-korea","suwon-south-korea","changhua-taiwan","kaohsiung-city-taiwan","tainan-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 1 / Phase 2: testing INBRX-106 - Hexavalent OX40 agonist antibody for Solid Tumor","inPlainEnglish":"This is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.","whoItsFor":["Ages 18 Years to any","Males or females aged ≥18 years","Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists","For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen","All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements","Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol"],"whoShouldSkip":["Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways","Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions","Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)","Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessments of INBRX-106","Grade ≥ 3 immune-related side effects (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply","Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply","Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply"],"whatHappens":"If you join, the listed intervention(s) are INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, or pembrolizumab 400 mg. The registry lists allocation as randomized. This is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 340 people at 60 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.803Z"},{"nctId":"NCT04210284","title":"Oral Nutritional Optimization in Total Joint Arthroplasty","officialTitle":"Oral Nutritional Optimization in Total Joint Arthroplasty","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"The purpose of this study is to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.","conditions":["Osteoarthritis"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Ensure"}],"enrollment":72,"startDate":"2021-07-06","completionDate":"2026-12-31","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patient are current candidates for elective primary total hip and total knee arthroplasty\n2. Patients ≥55 years of age but ≤ 95\n3. Patients who meet at least one of the following three laboratory criteria for malnutrition:\n\nTSerum Albumin: ≤3.5 mg/dl Pre-Albumin: \\<15 mg/dl Transferrin: \\<200 mg/dl\n\nExclusion Criteria:\n\n1. Previous history of septic arthritis\n2. Allergy to oral supplementation\n3. Inability to consume oral supplementation\n4. Protein malabsorption syndromes\n5. Eating disorders\n6. End stage renal and hepatic disease\n7. Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rothman Orthopedic Institute","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel Waren","phone":"212-598-6245","email":"Daniel.waren@nyulangone.org"}],"primaryOutcomes":["Changes in the patients' albumin, pre-albumin, and/or transferrin levels"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["new-york-new-york","philadelphia-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Ensure for Osteoarthritis","inPlainEnglish":"This study wants to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.","whoItsFor":["Ages 55 Years to any","Patient are current candidates for elective primary total hip and total knee arthroplasty","Patients ≥55 years of age but ≤ 95","Patients who meet at least one of the following three laboratory criteria for malnutrition:","TSerum Albumin: ≤3.5 mg/dl Pre-Albumin: \\<15 mg/dl Transferrin: \\<200 mg/dl"],"whoShouldSkip":["Previous history of septic arthritis","Allergy to oral supplementation","Inability to consume oral supplementation","Protein malabsorption syndromes","End stage renal and hepatic disease","Revision surgery, non-elective surgery, hemiarthroplasty, and unicompartmental knee arthroplasty"],"whatHappens":"If you join, the listed intervention(s) are Ensure. The registry lists allocation as randomized. This study wants to determine the effect on hematological markers of nutritional intervention on nutritionally deficient patients following total joint replacement surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.523Z"},{"nctId":"NCT04220190","title":"RAPA-501 Therapy for ALS","officialTitle":"Phase 2/3 Trial of Autologous Hybrid TREG/Th2 (RAPA-501) T Stem Cell Therapy for Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Rapa Therapeutics LLC","sponsorClass":"INDUSTRY","summary":"RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["Amyotrophic Lateral Sclerosis","RAPA-501","Autologous TREG/Th2 T stem cell therapy","Orphan Disease","rare disease"],"interventions":[{"type":"BIOLOGICAL","name":"RAPA-501 Autologous T stem cells"}],"enrollment":41,"startDate":"2025-01-02","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years of age.\n2. Patients with sporadic or familial amyotrophic lateral sclerosis (ALS) diagnosed as laboratory-supported possible, probable, or definite according to World Federation of Neurology El Escorial Criteria.\n3. . Less than or equal to 24 months since ALS symptom onset.\n4. Total ALSFRS-R score between 34 and 45.\n5. Must have a source of autologous T cells potentially sufficient to manufacture RAPA-501 cells, as defined by a peripheral CD3+ T cell count ≥ 500 cells per μl.\n6. Patients may continue riluzole (Rilutek®), and/or edaravone (Radicava®), and/or sodium phenylbutyrate/taurusodial (Relyvrio™) if on a stable dose for at least 30 days prior to the screening visit.\n7. Patients must be ≥ 2 two weeks removed from major surgery or investigational therapy.\n8. Patients must have recovered from clinical toxicities (\\[resolution of CTCAE(v5) \\[version 5\\] toxicity to a value of ≤ 2\\].).\n9. Serum creatinine ≤ less than or equal to 2.0 mg/dL.\n10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN).\n11. Bilirubin ≤ 1.5 (except if due to Gilbert's disease).\n12. Pulmonary slow vital capacity (SVC) ≥ 70% of predicted normal.\n13. No history of abnormal bleeding tendency.\n14. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient participant at any time without prejudice to future medical care.\n\nExclusion Criteria:\n\n1. Active uncontrolled infection.\n2. Hypertension not adequately controlled by ≤ 3 medications.\n3. History of documented pulmonary embolus within 6 months of enrollment.\n4. Clinically significant cardiac pathology, as defined by: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to NYHA, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n5. Patients with history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.\n6. HIV, hepatitis B, or hepatitis C seropositive.\n7. Pregnancy or breastfeeding patients.\n8. Patients of Subjects of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception.\n9. Patients Subjects may be excluded at the Principal Investigator discretion of the PI or if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel Fowler, M.D. Chief Medical Officer, RAPA Therapeutics, LLC","phone":"(301) 518-3104","email":"dan@rapatherapeutics.com"},{"name":"Jennifer Sunga, M.S. Senior Regulatory Affairs Associate, RAPA Therapeutics, LLC","phone":"","email":"jsunga@rapatherapeutics.com"}],"primaryOutcomes":["In the expansion cohort enrolling standard-risk pwALS, determine the feasibility and safety of the highest established safe dose of RAPA-501 (80 x 10^6 cells per infusion)."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2 / Phase 3: testing RAPA-501 Autologous T stem cells for Amyotrophic Lateral Sclerosis","inPlainEnglish":"RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).","whoItsFor":["Ages 18 Years to any","Male or female patients ≥ 18 years of age","Patients with sporadic or familial amyotrophic lateral sclerosis (ALS) diagnosed as laboratory-supported possible, probable, or definite according to World Federation of Neurology El Escorial Criteria",". Less than or equal to 24 months since ALS symptom onset","Total ALSFRS-R score between 34 and 45","Must have a source of autologous T cells potentially sufficient to manufacture RAPA-501 cells, as defined by a peripheral CD3+ T cell count ≥ 500 cells per μl","Patients may continue riluzole (Rilutek®), and/or edaravone (Radicava®), and/or sodium phenylbutyrate/taurusodial (Relyvrio™) if on a stable dose for at least 30 days prior to the screening visit","Patients must be ≥ 2 two weeks removed from major surgery or investigational therapy"],"whoShouldSkip":["Active uncontrolled infection","Hypertension not adequately controlled by ≤ 3 medications","History of documented pulmonary embolus within 6 months of enrollment","Patients with history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis","HIV, hepatitis B, or hepatitis C seropositive","Pregnancy or breastfeeding patients","Patients of Subjects of childbearing age, or males who have a partner of childbearing potential, who are unwilling to practice contraception"],"whatHappens":"If you join, the listed intervention(s) are RAPA-501 Autologous T stem cells. The registry lists allocation as na. RAPA-501-ALS is a phase 2/3 expansion cohort study of RAPA-501 autologous hybrid TREG/Th2 cells in patients living with amyotrophic lateral sclerosis (pwALS).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 41 people at Boston. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.620Z"},{"nctId":"NCT04222413","title":"Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","officialTitle":"First-in-Human Phase I Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nMetastasis is the spread of cancer from one organ to a nonadjacent organ. It causes 90% of cancer deaths. No treatment specifically prevents or reduces metastasis. Researchers hope a new drug can help. It stops cancer cells from growing and spreading further and possibly shrink cancer lesions in distant organs.\n\nObjective:\n\nTo find a safe dose of metarrestin and to see if this dose shrinks tumors.\n\nEligibility:\n\nAdults age 18 and older with pancreatic cancer, breast cancer, or a solid tumor that has not been cured by standard therapies. Also, children age 12-17 with a solid tumor (other than a muscle tumor) with no standard therapy options.\n\nDesign:\n\nParticipants will be screened with:\n\n* blood tests\n* physical exam\n* documentation of disease confirmation or tumor biopsy\n* electrocardiogram to evaluate the heart\n* review of their medicines and their ability to do their normal activities\n\nParticipants will take metarrestin by mouth until they cannot tolerate it or stop to benefit from it. They will keep a medicine diary.\n\nParticipants will visit the Clinical Center. During the first month there are two brief hospital stays required with visits weekly or every other week thereafter. They will repeat some of the screening tests. They will fill out questionnaires. They will have tests of their cognitive function. They will have an electroencephalogram to record brain activity. They will have a computed tomography (CT) scan or magnetic resonance imaging (MRI). A CT is a series of X-rays of the body. An MRI uses magnets and radio waves to take pictures of the body.\n\nAdult participants may have tumor biopsies.\n\nParticipants will have a follow-up visit 30 days after treatment ends. Then they will have follow-up phone calls or emails every 6 months for the rest of their life or until the study ends.\n\n...","conditions":["Advanced Solid Tumors","Metastatic Pancreatic Cancer","Pediatric Solid Tumor","Advanced Breast Cancer","Malignant Peripheral Nerve Sheath Tumor","Colorectal Neoplasms"],"keywords":["First-In-Class Investigational Agent","Peri-Nucleolar Compartment (PNC)","effective therapies against metastasis","Oral Administration","Maximum Recommended Starting Dose"],"interventions":[{"type":"DRUG","name":"Metarrestin"}],"enrollment":116,"startDate":"2020-10-27","completionDate":"2027-12-31","sex":"ALL","minAge":"12 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Adult (\\>= 18 years) subjects with:\n\n  * histologically or cytologically confirmed solid tumors (Phase IA).\n\nOR\n\n--histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)\n\nOR\n\n* Pediatric (\\>=12 and \\< 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell/sclerosing, and pleomorphic subtypes of RMS (Phase IB).\n* Subjects must have disease that:\n\n  * is not amenable to potentially curative resection,\n  * spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor,\n  * has site measurable per RECIST 1.1 (Phase IB only).\n  * progressed on or after at least one line of standard systemic chemotherapy (Phase IA and IB1)\n  * have no standard therapy option available (Phase IB2)\n* Patients must have recovered from any acute toxicity related to prior therapy or surgery or disease to a grade 1 or less.\n* Performance status\n\n  * Karnofsky \\>= 70% (for patients \\>= 16 years old), Lansky \\>= 70% (for patients \\<16 years old)\n* Adequate hematological function defined by:\n\n  * absolute neutrophil count (ANC) \\>= 1.0 x 10(9)/L,\n  * transfusion-independent platelet count \\>= 100 x 10(9)/L,\n  * Hgb \\>= 9 g/ dL (patients who have received \\<= 2 PRBC transfusions within 48 hours are eligible)\n* Adequate coagulation as defined by:\n\n  --INR\\<1.5 (or \\< 3.0 if subjects are currently taking anticoagulated medications) Note: increase of the upper limit of INR is restricted only to subjects who are receiving anticoagulation for medical reasons (DVT/PE prophylaxis, treatment for a thromboembolic event) and have increased INR because of these medications. Patients who have an elevated INR due to compromised liver function or any other medical conditions remain excluded\n* Adequate hepatic function defined by:\n\n  --a total bilirubin level \\<= 1.5 x ULN, (total bilirubin \\<= 2.0 x ULN in case of prior diagnosis of Gilbert syndrome)\n  * an AST level \\<= 3xULN\n  * an ALT level \\<= 3 xULN\n* Adequate renal function defined by:\n\n  --Creatinine OR Measured or calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\\*\n\n  ---\\< 1.5x institution upper limit of normal OR\n\n  ---\\>= 45 mL/min/1.73 m\\^2 for participant with creatinine levels \\>= 1.5 X institutional ULN\n\n  \\*Creatinine clearance (CrCl) or eGFR should be calculated per institutional standard.\n* The effects of the study treatment on the developing human fetus are unknown; thus, individuals of childbearing potential and individuals who can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior\n\nto study entry, for the duration of study therapy and up to 120 days after the last dose of the study drug.\n\n* Nursing participants must be willing to discontinue nursing at the time of the study treatment initiation.\n* Weight: \\>= 35 kg (\\>= 18 years old) or \\>=40 kg (\\>= 12 and \\< 18 years old).\n* Ability of subject or parent/guardian to understand and the willingness to sign a written informed consent document.\n* Subjects must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies (Cohort IB1 only).\n* Ability to swallow oral capsules.\n\nEXCLUSION CRITERIA:\n\n* Anticancer treatment within designated period before treatment initiation including:\n\n  * minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;\n  * major surgical procedure or curative radiation treatment within 28 days;\n  * palliative radiation treatment within 14 days;\n  * chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;\n  * experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;\n  * chemotherapy regimen containing an alkylating antineoplastic agent (cyclophosphamide, chlorambucil, melphalan, or ifosfamide), alkylating-like (platinumbased chemotherapeutic drugs, platinum analogues), and non-classical alkylating agent (dacarbazine, temozolomide) within 28 days.\n* Patients receiving any medications or substances that are moderate and strong inhibitors or inducers of CYP3A4 and are not able to safely stop these medications are excluded from this study; patients must stop strong CYP3A4 inhibiting/inducing medications within 5 published half-lives and moderate within 3 published half-lives prior to the treatment initiation.\n\nNote: dihydropyridine calcium - channel blockers are permitted for management of underling disease.\n\n* Patients receiving medications known to carry a high to moderate risk to lower seizure threshold within 2 weeks prior to treatment initiation.\n* Subjects with cardiomyopathy diagnosed within 6 months prior to treatment initiation including but not limited to the following:\n\n  * hypertrophic cardiomyopathy\n  * arrhythmogenic right ventricular cardiomyopathy\n  * abnormal ejection fraction (echocardiogram \\[ECHO\\]) \\<= 53% (if a range is given then the upper value of the range will be used)\n  * previous moderate or severe impairment of left ventricular systolic function (LVEF \\<45%)\n  * severe valvular heart disease\n  * atrial fibrillation with a ventricular rate \\>100 bpm on EKG at rest\n  * Fridericia's corrected QT interval (QTcF) \\>= 480 msec (adults) or \\>= 460 msec (pediatric subjects, aged 12 to \\<18 years) or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome.\n* HIV, HCV, HBV positive patients on antiviral drugs are excluded due to the absence of previous experience with concurrent use of antiviral medications and the investigational drug product to be evaluated in the current study and possible for adverse pharmacokinetic and/or pharmacodynamic interactions.\n* Previous malignant disease (other than the target malignancy to be investigated in this trial) within the last 3 years. Note: subjects with a history of cervical carcinoma in situ, superficial or non-invasive bladder cancer, or basal cell or squamous cell carcinoma in situ previously treated with curative intent are NOT excluded.\n* Rapidly progressive disease which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or trial procedures.\n* Significant acute or chronic infections including tuberculosis with presence of clinical symptoms or physical findings.\n* Patients with a history of any seizures within 1 year prior to the study treatment initiation or increased risk of seizures on screening EEGs defined by 1) interictal epileptiform discharges, 2) temporal intermittent rhythmic delta activity (TIRDA), or 3) electrographic or clinical seizures on EEG. Note: Patients with brain metastasis are eligible providing that patients had no seizures or clinical signs of central nervous system (CNS) disease-related neurotoxicity (ataxia, sensory, cognitive changes) within 1 year prior to the study treatment initiation and baseline EEG shows no changes indicative of increased seizure risk.\n* Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial.\n* Patients with previous gastric bypass, patients receiving nutrition via feeding tubes or parenterally, or patients with malabsorptive conditions (damage to the intestine from infection, inflammation, trauma, or surgery, celiac disease, Crohn's disease, chronic pancreatitis, or cystic fibrosis resulting malabsorption). Patients with refractory nausea and vomiting. Note: patients with gastric banding are allowed.\n* Pregnant individuals.","locations":[{"facility":"University of Kansas","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Murielle Hogu","phone":"(240) 858-3335","email":"murielle.hogu@nih.gov"},{"name":"Udo Rudloff, M.D.","phone":"(240) 760-6238","email":"rudloffu@mail.nih.gov"}],"primaryOutcomes":["To identify the maximum tolerated dose (MTD) of metarrestin in subjects with metastatic solid tumors","To determine the Objective Response Rate (ORR) according to Evaluation Criteria (RECIST 1.1) in patients treated with metarrestin at the MTD"],"hasResults":false,"conditionSlugs":["breast-cancer","pancreatic-cancer","als"],"drugSlugs":[],"locationSlugs":["fairway-kansas","bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Metarrestin for Advanced Solid Tumors","inPlainEnglish":"Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. No treatment specifically prevents or reduces metastasis.","whoItsFor":["Ages 12 Years to 120 Years","Adult (\\>= 18 years) subjects with:","histologically or cytologically confirmed solid tumors (Phase IA)","histologically or cytologically confirmed pancreatic, colorectal, or breast cancer (Phase IB)","Pediatric (\\>=12 and \\< 18 years) subjects with histologically or cytologically confirmed solid tumors other than rhabdomyosarcoma (RMS) including embryonal, alveolar, spindle cell/sclerosing, and pleomorphic subtypes of RMS (Phase IB)","Subjects must have disease that:","is not amenable to potentially curative resection,","spread at least to one other organ system other than primary tumor or recurred after removal of primary tumor,"],"whoShouldSkip":["Anticancer treatment within designated period before treatment initiation including:","minor surgical procedure (such as biliary stenting) within 14 days. Note: if liver function tests after biliary stenting or renal function tests after ureteral stenting return to normal, within 5 days after biliary or ureteral stenting;","major surgical procedure or curative radiation treatment within 28 days;","palliative radiation treatment within 14 days;","chemotherapy or experimental drug treatment with published half-life known to be 72 hours or less within 14 days;","experimental drug treatment with unpublished or half-life greater than 72 hours within 28 days;","Note: dihydropyridine calcium - channel blockers are permitted for management of underling disease"],"whatHappens":"If you join, the listed intervention(s) are Metarrestin. The registry lists allocation as randomized. Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 116 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.968Z"},{"nctId":"NCT04251052","title":"A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer","officialTitle":"A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers [SOROCk]","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NRG Oncology","sponsorClass":"OTHER","summary":"This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.","conditions":["Ovarian Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Bilateral Salpingectomy"},{"type":"PROCEDURE","name":"Bilateral Salpingectomy with Oophorectomy"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Quality-of-Life Assessment"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"PROCEDURE","name":"Transvaginal Ultrasound"},{"type":"PROCEDURE","name":"Ultrasound Imaging"}],"enrollment":1956,"startDate":"2020-09-01","completionDate":"2047-06-30","sex":"FEMALE","minAge":"35 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals 35-50 years of age, inclusive\n* Patients who will undergo risk-reducing salpingo-oophorectomy (RRSO) (for the BSO arm) and patients who have declined or elected to defer BSO after proper counselling to clearly explain the standard of care for BRCA1 mutation carriers and are undergoing salpingectomy (for the BLS arm with delayed oophorectomy arm). Concurrently planned hysterectomy with either arm is permitted\n* At least one intact ovary and fallopian tube is in situ at the time of counseling, consent, and registration. Prior hysterectomy is allowed provided it did not include bilateral salpingectomy. Prior tubal ligation is allowed if one ovary and fallopian tube (with fimbria not removed) are present\n* Positive Clinical Laboratory Improvement Act (CLIA)-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient. Documentation of the result is required\n* Patients may be premenopausal or menopausal\n* Pelvic ultrasound (transvaginal imaging preferred, but transabdominal imaging is acceptable) or pelvic MRI and CA-125 within 180 days of registration\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry\n* Individuals who are currently pregnant or plan to become pregnant in the future through assisted reproductive technologies and who have received proper counseling are eligible. Individuals who are currently pregnant and plan bilateral salpingectomy at the time of a planned cesarean section are eligible. Patients must understand that they will not be able to become pregnant naturally in the future\n\nExclusion Criteria:\n\n* Individuals with a history of any prior cancer who have received cytotoxic chemotherapy within the past 30 days or radiotherapy to abdomen or pelvis at any prior time. Endocrine therapy or maintenance ERBB2/HER2 targeted therapy is allowed. Maintenance immune checkpoint inhibitor therapy is allowed. Maintenance therapy with PARP in inhibitor is allowed.\n* Prior history of ovarian cancer, including low malignant potential neoplasms (LMP), primary peritoneal carcinoma, or fallopian tube carcinoma\n* Patients medically unfit for the planned surgical procedure\n* Patients with abnormal screening tests (pelvic ultrasound, pelvic MRI, CA-125) suspicious for occult or gross pelvic malignancy within the past 180 days\n\n  * An abnormal pelvic ultrasound (or pelvic MRI) is defined as morphologic or structural variations suspicious for ovarian malignancy. Complex cystic lesions felt to represent a benign lesion are not exclusionary. Simple cysts of any size are not exclusionary\n  * An abnormal CA-125 is defined as a level \\> 50U/ml in premenopausal individuals if they are not current users of oral contraceptives; an abnormal CA-125 is defined as a level \\> 40U/ml for premenopausal individuals who are current users of oral contraceptives (Skates 2011). An abnormal CA-125 is defined as a level \\> 35 U/ml in postmenopausal individuals","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTCA at Western Regional Medical Center","city":"Goodyear","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Deer Valley Medical Center","city":"Antioch","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medicine of USC Buena Park","city":"Buena Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Joseph Medical Center/Disney Family Cancer Center","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Carmichael","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy San Juan Medical Center","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Elk Grove","city":"Elk Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fresno Cancer Center","city":"Fresno","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser 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Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.177Z"},{"nctId":"NCT04267848","title":"Testing the Addition of a Type of Drug Called Immunotherapy to the Usual Chemotherapy Treatment for Non-small Cell Lung Cancer, an ALCHEMIST Treatment Trial (Chemo-IO [ACCIO])","officialTitle":"Integration of Immunotherapy Into Adjuvant Therapy for Resected NSCLC: ALCHEMIST Chemo-IO (ACCIO)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.","conditions":["Lung Non-Small Cell Carcinoma","Lung Non-Small Cell Squamous Carcinoma","Lung Non-Squamous Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Gemcitabine Hydrochloride"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Observation Activity"},{"type":"DRUG","name":"Paclitaxel"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Pemetrexed Disodium"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":1210,"startDate":"2020-06-16","completionDate":"2030-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* A female of childbearing potential is a sexually mature female who:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)\n* Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)\n* Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)\n* Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263\n* Completely resected stage IIA, IIB IIIA or IIIB (T3-4N2) non-small cell lung cancer (NSCLC) (squamous or non-squamous) with negative margins (complete R0 resection). Patients will be staged according to the 8th edition of the American Joint Committee on Cancer (AJCC) Staging Manual, 2017\n\n  * Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population\n* Complete recovery from surgery. Registration to A081801 must be 30-77 days following surgery\n* No prior neoadjuvant or adjuvant therapy for current lung cancer diagnosis\n* No prior allogeneic tissue/solid organ transplant\n* Patients must NOT have uncontrolled intercurrent illness including, but not limited to, serious ongoing or active infection, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia, unstable angina pectoris, that would limit compliance with study requirements\n* No current pneumonitis or history of (non-infectious) pneumonitis that required steroids\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-1\n* No active auto-immune disease that has required systemic treatment within the last 2 years (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid release therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done =\\< 7 days prior to registration is required\n* No patients with a \"currently active\" second malignancy that is progressing or has required active treatment within the last 3 years. Participants with non-melanoma skin cancers, low grade or low-risk cancers, or stage I malignancies not requiring systemic therapy (e.g., prostate cancer requiring only observation or superficial bladder cancer), or carcinoma in situ (e.g., breast carcinoma or cervical cancer in situ) that have undergone potentially curative therapy are eligible\n* No hypersensitivity (\\>= grade 3) to pembrolizumab and/or any of its excipients\n* No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed\n* No known hepatitis C virus (defined as HCV ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected) infection or known history of hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive)\n* Absolute neutrophil count (ANC) \\>= 1,500/mm\\^3\n* Platelet count \\>= 100,000/mm\\^3\n* Hemoglobin \\>= 8 gm/dl\n* Calculated (Calc.) creatinine clearance \\>= 45 mL/min\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) =\\< 2.5 x upper limit of normal (ULN)","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy 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3: testing Carboplatin for Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","A female of childbearing potential is a sexually mature female who:","Has not undergone a hysterectomy or bilateral oophorectomy; or","Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)","Local testing of EGFR with no EGFR exon 19 deletion or EGFR L858 R mutation (applicable to non-squamous patients only)","Local testing of ALK with no ALK rearrangement (failed testing is considered negative) (applicable to non-squamous patients only)","Local testing of PD-L1 immunohistochemistry (IHC) using one of the following assays: DAKO 22C3, DAKO 28-8, EIL3N or SP263","Note: Patients with pathologic N2 disease, completely resected, are eligible. However, patients known to have N2 disease prior to surgery are not eligible; guidelines do not recommend up-front surgery for this population"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Carboplatin, or Cisplatin. The registry lists allocation as randomized. This phase III ALCHEMIST treatment trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,210 people at 1151 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.657Z"},{"nctId":"NCT04278404","title":"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","officialTitle":"Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Duke University","sponsorClass":"OTHER","summary":"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.","conditions":["Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Attention Deficit Hyperactivity Disorder","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:"}],"enrollment":5000,"startDate":"2020-03-05","completionDate":"2026-11","sex":"ALL","minAge":"0 Years","maxAge":"20 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant is \\< 21 years of age\n2. Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","locations":[{"facility":"Phoenix Children's Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Arkansas Children's Hospital Research Institute","city":"Little Rock","state":"Arkansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of California, Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lucile Packard Children's Hospital","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado University Denver","city":"Aurora","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Alfred I. DuPont Hospital for Children","city":"Wilmington","state":"Delaware","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Florida Jacksonville Shands Medical Center","city":"Jacksonville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Kapiolani Womens and Childrens Medical Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Ann and Robert H. Lurie Childrens Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Riley Hospital for Children at Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Iowa Stead Family Children's Hospital","city":"Iowa City","state":"Iowa","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Kansas Medical Center-JG Kidney Institute","city":"Kansas City","state":"Kansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Louisville Norton Childrens Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Tulane University Health Science Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Ochsner Baptist Clinical Trials Unit","city":"New Orleans","state":"Louisiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Maryland Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Lexington","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Mississippi Medical Center","city":"Jackson","state":"Mississippi","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mississippi Center for Advanced Medicine","city":"Madison","state":"Mississippi","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Children's Mercy Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of New Mexico Health Science Center","city":"Albuquerque","state":"New Mexico","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Duke University Health System","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Childrens Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Board of Regents of the University of Oklahoma","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Pennsylvania State University--Hershey Children's Hospital","city":"Hershey","state":"Pennsylvania","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rhode Island Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Medical University of South Carolina Children's Hospital","city":"Charleston","state":"South Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of South Carolina","city":"Columbia","state":"South Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Avera McKennan Hospital & University Medical Center","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Monroe Carell Jr. Children's Hospital at Vanderbilt","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Dell Children's Medical Center of Central Texas","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas-Southwestern Medical Center Dallas","city":"Dallas","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Texas--Memorial Hermann Texas Medical Center","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Womens Hospital of Texas","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"West Virginia University Hospital","city":"Morgantown","state":"West Virginia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University Wisconsin Madison","city":"Madison","state":"Wisconsin","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"CHU Sainte-Justine","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chi Hornik","phone":"(919) 260-7626","email":"chi.hornik@duke.edu"},{"name":"Melissa James, MPH, RD","phone":"(704) 502-6491","email":"melissa.james@duke.edu"}],"primaryOutcomes":["Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling","Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling","Elimination rate constant (ke) as measured by PK sampling","Half-life (t1/2) as measured by PK sampling","Absorption rate constant (ka) as measured by PK sampling","AUC (area under the curve) as measured by PK sampling","Maximum concentration (Cmax) as measured by PK sampling","Time to achieve maximum concentration (Tmax) as measured by PK sampling"],"hasResults":false,"conditionSlugs":["adhd","heart-failure","hypertension","asthma"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","little-rock-arkansas","los-angeles-california","palo-alto-california","aurora-colorado","wilmington-delaware","jacksonville-florida","honolulu-hawaii","chicago-illinois","indianapolis-indiana","iowa-city-iowa","kansas-city-kansas","louisville-kentucky","new-orleans-louisiana","baltimore-maryland","boston-massachusetts","lexington-massachusetts","minneapolis-minnesota","jackson-mississippi","madison-mississippi","kansas-city-missouri","omaha-nebraska","lebanon-new-hampshire","albuquerque-new-mexico","chapel-hill-north-carolina","durham-north-carolina","cincinnati-ohio","oklahoma-city-oklahoma","portland-oregon","hershey-pennsylvania","providence-rhode-island","charleston-south-carolina","columbia-south-carolina","sioux-falls-south-dakota","nashville-tennessee","austin-texas","dallas-texas","houston-texas","salt-lake-city-utah","seattle-washington","morgantown-west-virginia","madison-wisconsin","milwaukee-wisconsin","toronto-canada","montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: testing The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: for Coronavirus Infection (COVID-19)","inPlainEnglish":"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to measure the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.","whoItsFor":["Ages 0 Years to 20 Years","Participant is \\< 21 years of age","(a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment"],"whoShouldSkip":["Participant has a known pregnancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at 50 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.982Z"},{"nctId":"NCT04309461","title":"Make Better Choices 2 for Rural Appalachians","officialTitle":"Implementing the Make Better Choices 2 mHealth Energy Balance Intervention for Rural Appalachians","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Nancy Schoenberg","sponsorClass":"OTHER","summary":"The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.","conditions":["Health Behavior"],"keywords":["app","coaching","Appalachian"],"interventions":[{"type":"BEHAVIORAL","name":"Stress Management Control"},{"type":"BEHAVIORAL","name":"Adapted MBC2 Program"}],"enrollment":279,"startDate":"2020-08-01","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* adults residing in Appalachian Kentucky\n* willingness to use smart phone to record and modify diet and activity\n* willingness to wear an accelerometer\n* consume \\<4.5 cups fruit/vegetables daily\n* consume \\>8% daily calories from fat\n* engage in \\<150 minutes of moderate-intensity physical activity weekly\n* spend \\>90 minutes daily on non-work, non-education-related sedentary recreational use of screen time.\n\nExclusion Criteria:\n\n* unstable medical conditions\n* cognitive impairment\n* hospitalization for psychiatric disorder within the last 5 years\n* active suicidal ideation\n* substance use disorder other than nicotine dependence\n* at risk for adverse cardiovascular events with moderate-intensity activity\n* taking weight loss medication\n* trying to get pregnant, pregnant or lactating\n* active eating disorders\n* using mobility assistive devices\n* inability to read study materials","locations":[{"facility":"MBC2 Field Office University of Kentucky","city":"Benham","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Susan C Westneat, MA","phone":"859 323 8282","email":"swest1@email.uky.edu"}],"primaryOutcomes":["Change in diet and activity"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["benham-kentucky"],"enrichment":{"headline":"Not a traditional drug phase: Stress Management Control for Health Behavior","inPlainEnglish":"The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.","whoItsFor":["Ages 18 Years to 100 Years","adults residing in Appalachian Kentucky","willingness to use smart phone to record and modify diet and activity","willingness to wear an accelerometer","consume \\<4.5 cups fruit/vegetables daily","consume \\>8% daily calories from fat","engage in \\<150 minutes of moderate-intensity physical activity weekly","spend \\>90 minutes daily on non-work, non-education-related sedentary recreational use of screen time"],"whoShouldSkip":["unstable medical conditions","cognitive impairment","hospitalization for psychiatric disorder within the last 5 years","active suicidal ideation","substance use disorder other than nicotine dependence","at risk for adverse cardiovascular events with moderate-intensity activity","taking weight loss medication"],"whatHappens":"If you join, the listed intervention(s) are Stress Management Control, or Adapted MBC2 Program. The registry lists allocation as randomized. The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 279 people at Benham. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.317Z"},{"nctId":"NCT04317820","title":"Deep Brain Reorienting in Post-traumatic Stress Disorder","officialTitle":"The Effects of Deep Brain Reorienting (DBR) on Post-traumatic Stress Disorder (PTSD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","sponsorClass":"OTHER","summary":"This study will evaluate the efficacy of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). Participants will be randomized to either the DBR treatment, or wait-list condition.\n\nWhile enrollment for the first phase of the study has ended, a second phase has begun, which focuses on DBR treatment in military veterans.","conditions":["PTSD","Post-traumatic Stress Disorder"],"keywords":["Deep Brain Reorienting","DBR","military","veterans"],"interventions":[{"type":"BEHAVIORAL","name":"Deep Brain Reorienting (DBR)"}],"enrollment":234,"startDate":"2020-09-29","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* military veteran\n* English speaking\n* age: 18-65\n* meets diagnostic criteria for PTSD (as determined by study assessment)\n* may benefit from short-term trauma therapy (as determined by study assessment)\n\nExclusion Criteria:\n\n* not a military veteran\n* Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)\n* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \\< 15 at the time of incident assessed retrospectively by participant)\n* significant untreated medical illness\n* history of neurological disorder\n* history of any pervasive developmental disorder\n* history of bipolar disorder\n* history of psychotic disorder\n* alcohol/substance abuse or dependence within the last 3 months\n* extensive narcotic use\n* current participation in counselling more extensive than supportive therapy (e.g., exposure therapy, Cognitive-Behavioural Therapy would be an exclusion)\n* a degree of mental distress that is unlikely to benefit from a short-term therapy (for our participants' well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).","locations":[{"facility":"London Health Sciences Centre - University Hospital","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Suzy - Study Coordinator","phone":"519-685-8500","email":"Suzy.Southwell@lhsc.on.ca"}],"primaryOutcomes":["change in PTSD symptoms from baseline as measured by the Clinician Administered PTSD Scale (CAPS) at post-treatment assessment","change in PTSD symptoms from post-treatment assessment as measured by the Clinician Administered PTSD Scale (CAPS) at follow-up assessment"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["london-canada"],"enrichment":{"headline":"Not a traditional drug phase: Deep Brain Reorienting (DBR) for PTSD","inPlainEnglish":"This study will measure the how well it works of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder). you would be randomly assigned to either the DBR treatment, or wait-list condition.","whoItsFor":["Ages 18 Years to 65 Years","meets diagnostic criteria for PTSD (as determined by study assessment)","may benefit from short-term trauma therapy (as determined by study assessment)"],"whoShouldSkip":["not a military veteran","Individuals with any implants, conditions, etc. that do not comply with 7-Tesla (7T) fMRI research safety standards (e.g., certain implants, pregnancy)","history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \\< 15 at the time of incident assessed retrospectively by participant)","significant untreated medical illness","history of neurological disorder","history of any pervasive developmental disorder","history of bipolar disorder"],"whatHappens":"If you join, the listed intervention(s) are Deep Brain Reorienting (DBR). The registry lists allocation as randomized. This study will measure the how well it works of a therapeutic treatment, Deep Brain Reorienting (DBR), for PTSD (Post-traumatic Stress Disorder).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 234 people at London. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.408Z"},{"nctId":"NCT04339764","title":"Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration","officialTitle":"A Phase I/IIa Trial for Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\nAge-related macular degeneration is a common eye disease in people over 50. The \"dry\" form of the disease can worsen into geographic atrophy, causing blind spots. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease.\n\nObjective:\n\nTo test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration.\n\nEligibility:\n\nPeople ages 55 and older who have geographic atrophy with loss of vision. People who have had \"wet\" macular degeneration in study eye are NOT eligible.\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Blood and urine tests\n* Eye exam\n* Eye photos\n* Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels.\n* Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights.\n* Tuberculosis test\n* Chest X-ray\n* Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity.\n\nParticipants will have at least 14 study visits over 5 and a half years. They will repeat screening tests.\n\nParticipants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will receive immunosuppressive medications to avoid transplant rejection.\n\nParticipants will be contacted yearly for up to 15 years.","conditions":["Dry Age-Related Macular Degeneration","Geographic Atrophy"],"keywords":["Retina","Cell Therapy","Vitrectomy"],"interventions":[{"type":"DRUG","name":"iPSC-derived RPE/PLGA transplantation"}],"enrollment":20,"startDate":"2020-09-23","completionDate":"2029-05-31","sex":"ALL","minAge":"55 Years","maxAge":"95 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipant Eligibility Criteria:\n\nTo be eligible, the following inclusion criteria must be met, where applicable.\n\n* Participant must be 55 years of age or older.\n* Participant must have a diagnosis of dry AMD, defined as presence (or history, as documented in available color fundus photographs) of at least one medium or large druse (greater than or equal to 63 micrometer diameter) in the macula in at least one eye; AND presence of GA in at least one eye.\n* Participant must understand and sign the protocol s informed consent document.\n* Any participant of childbearing potential must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to RPE transplantation.\n* Any participant of childbearing potential and any participant able to father children who has a partner of childbearing potential must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or must agree to practice an effective method of contraception through Month 12 in the study. Acceptable methods of contraception include:\n\n  * Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),\n  * Intrauterine device,\n  * Barrier methods (diaphragm, condom) with spermicide, or\n  * Surgical sterilization (tubal ligation).\n* Participant must be medically able to comply with the study treatment (including ability to safely receive anesthesia for surgery), study testing and procedures, and follow-up visits.\n\nStudy Eye/Fellow Eye Eligibility Criteria\n\nThe participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below. The fellow eye must also meet the relevant eligibility criteria listed below.\n\nStudy Eye Inclusion Criteria:\n\n* The study eye must have one or more regions of geographic atrophy with total area of 1 disc area or more. A region of geographic atrophy is defined as an area of uniform hypofluorescence on fundus autofluorescence (FAF) imaging, with greatest linear dimension at least 500 micrometer, with a border within 500 micrometer of the foveal center, not compatible with pigmentary changes, drusen, RPE detachment, drusenoid RPE detachment, hemorrhage, or other lesion. (Note: If macular geographic atrophy is contiguous with peripapillary atrophy, complicating calculation of total area, only atrophy temporal to a vertical line placed a half disc diameter temporal to the temporal border of the disc will be included in the total area of geographic atrophy calculated for eligibility purposes.)\n* For participants in the first cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \\<= 53 and \\>= CF (i.e., Snellen equivalent between 20/100 and CF), and the fellow eye must have a letter score no more than five letters worse than the study eye using Electronic Visual Acuity (EVA) testing. If the study eye is CF vision, then the fellow eye must be both (1) CF or better vision and (2) subjectively as good or better than the study eye according to the subject s perception. (Note: Letter scores within five or fewer letters of each other are accordingly considered equal for eligibility determination, and other factors may be used to select the study eye if both are eligible by BCVA.\n* For participants in the second cohort, the study eye must have an ETDRS best-corrected visual acuity (BCVA) letter score of \\<= 58 and \\>= CF (i.e., Snellen equivalent between 20/80 and CF), and the fellow eye must have a letter score no more than five letters worse than the study eye using Electronic Visual Acuity (EVA) testing. If the study eye is CF vision, then the fellow eye must be both (1) CF or better vision and (2) subjectively as good or better than the study eye according to the subject s perception. (Note: Letter scores within five or fewer letters of each other are accordingly considered equal for eligibility determination, and other factors may be used to select the study eye if both are eligible by BCVA.\n* The compromise in visual acuity for the study eye must be judged predominantly secondary to dry AMD, in the judgment of the investigator.\n* The study eye must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography and safe vitrectomy surgery.\n* The study eye must be either pseudophakic or aphakic.\n\nEXCLUSION CRITERIA:\n\nA participant is not eligible if any of the following exclusion criteria are present:\n\n* Participant is actively receiving another study medication / investigational product (IP).\n* Participant has any condition that significantly increases risk of systemic corticosteroids or systemic steroid-sparing immuno-modulatory agents, such as uncontrolled diabetes mellitus (defined as HbA1C \\> 7.5 at Baseline), chronic hepatitis or liver failure (defined, as elevated liver function tests (LFTs): alanine transaminase (ALT) or aspartate transaminase (AST) \\>= 2x upper limit of normal at Baseline), kidney disease with an eGFR \\<25 mL/min/1.73 m2 for 3 months or more or by any other evidence of disease chronicity, or present infection with HIV, syphilis, tuberculosis, hepatitis B, or hepatitis C (past infection now resolved, where applicable, is not exclusionary; but persistent infection, even if latent, is exclusionary).\n* Participant has diagnosis of a malignancy expected to affect two-year survival.\n* Participant is pregnant, breast-feeding, or planning to become pregnant through the first 12 months of the study.\n* Participant has a family history of a retinal degeneration other than AMD suspected to play a role in the ocular phenotype of the participant in the judgment of the investigator, based on disease features and mode of inheritance, such as in a case of autosomal dominant retinal degeneration in a parent or child.\n* Participant is taking, or has taken within the previous year, medication with known potential toxicity to the retina, optic nerve, or lens (such as chloroquine, hydroxychloroquine, ethambutol).\n* Participant is taking any form of systemic anticoagulation which cannot be stopped for an indefinite period of time without significant risk. The determination of significant risk to the participant must be at the discretion of the study investigators and prescribing physician (or qualified alternative).\n* Participant is unable or unwilling to give informed consent that includes use of medical records and clinical samples for current and future research.\n\nStudy Eye Exclusion Criteria:\n\n* The study eye has macular, subretinal or choroidal neovascularization, as assessed by FA and OCT; or any history of such neovascularization (as assessed by past available records or images).\n* The study eye has serous or hemorrhagic pigment epithelial detachment, as assessed by FA and OCT, that is clinically significant in the judgment of the investigator.\n* The study eye has a history of photodynamic therapy (PDT) or macular thermal laser photocoagulation, or history of intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents or corticosteroids (excepting medications used peri-operatively at prior cataract surgery). The study eye has had intravitreal injections (anti-complement therapy) for treatment of dry AMD in the previous 12 weeks before enrollment. Any intravitreal injections with anti-complement therapy prior to 12 weeks are not exclusionary.\n* The study eye has an axial length \\> 26.0 mm.\n* The study eye has had surgery in the previous 12 weeks, or laser capsulotomy in the previous four weeks.\n* The study eye has chronic glaucoma; OR significant ocular hypertension, defined as documented intraocular pressure of \\>= 26 mmHg on at least two occasions in the absence of self-limited acute glaucoma; OR history of probable or definite steroid response manifesting as acute glaucoma or ocular hypertension, even if self-limited and no longer present; OR the fellow eye has evidence for present or past glaucoma or ocular hypertension judged to significantly impact the risk of glaucoma in the study eye (including history of probable or definite steroid response). (Note: History of self-limited acute glaucoma in a study or fellow eye, if not secondary to steroid response, and if now resolved and not expected to recur (e.g., history of elevated intraocular pressure from retained visco-elastic after cataract surgery), is not exclusionary. History of glaucoma or ocular hypertension in the fellow eye, if not felt to significantly impact risk of glaucoma in the study eye, is not exclusionary.)\n* The study eye has a condition materially increasing the risks of surgery or potentially affecting visual function over the next two years in the judgment of the investigator, such as chronic uveitis, diabetic retinopathy, keratitis, scleritis, optic neuropathy, untreated retinal detachment, macular edema from prior vein occlusion or other cause, proliferative vitreoretinopathy (PVR), vitreous hemorrhage, pathologic myopia, etc. A history of such conditions is not exclusionary, if judged to not materially increase risks of surgery or to potentially affect vision in the next two years in the opinion of the investigator.","locations":[{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ellaine M Galindez-Balut","phone":"(301) 402-4726","email":"ellaine.galindez-balut@nih.gov"},{"name":"Emily Y Chew, M.D.","phone":"(301) 496-6583","email":"echew@nei.nih.gov"}],"primaryOutcomes":["Summary of adverse events","Visual acuity change"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["baltimore-maryland","bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing iPSC-derived RPE/PLGA transplantation for Dry Age-Related Macular Degeneration","inPlainEnglish":"Background: Age-related macular degeneration is a common eye disease in people over 50. The \"dry\" form of the disease can worsen into geographic atrophy, causing blind spots.","whoItsFor":["Ages 55 Years to 95 Years","Participant Eligibility Criteria:","To be eligible, the following who can join must be met, where applicable","Participant must be 55 years of age or older","Any participant of childbearing potential must have a negative pregnancy test at screening and must be willing to undergo pregnancy testing prior to RPE transplantation","Hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring),","Intrauterine device,","Barrier methods (diaphragm, condom) with spermicide, or"],"whoShouldSkip":["listed below. The fellow eye must also meet the relevant eligibility criteria listed below","Study Eye who can join:","The compromise in visual acuity for the study eye must be judged predominantly secondary to dry AMD, in the judgment of the investigator","The study eye must have clarity of ocular media and degree of pupil dilation sufficient to permit adequate fundus photography and safe vitrectomy surgery","The study eye must be either pseudophakic or aphakic"],"whatHappens":"If you join, the listed intervention(s) are iPSC-derived RPE/PLGA transplantation. The registry lists allocation as na. Background: Age-related macular degeneration is a common eye disease in people over 50.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.141Z"},{"nctId":"NCT04355572","title":"Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)","officialTitle":"Evaluation of the Clinical and Psychological Impact of Vitamin D Replacement in Adolescent Females at Risk for Polycystic Ovarian Syndrome (PCOS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"This study is a double blind, placebo controlled, randomized trial of study subjects with PCOS and low vitamin D to 2 groups- placebo and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period","conditions":["Polycystic Ovarian Syndrome in Adolescent Females","Vitamin D Deficiency"],"keywords":["Anti-Mullerian Hormone (AMH)"],"interventions":[{"type":"DRUG","name":"Vitamin D 4000IU daily"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2026-09","completionDate":"2028-08-31","sex":"FEMALE","minAge":"13 Years","maxAge":"21 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL.\n\nExclusion Criteria:\n\n* Other causes for hyperandrogenism,\n* Chronic renal diseases,\n* Acquired or inherited calcium and vitamin D metabolic disorders.","locations":[{"facility":"Yale New Haven Children's Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alla Vash-Margita, MD","phone":"203-785-4010","email":"alla.vash-margita@yale.edu"}],"primaryOutcomes":["Change in oligomenorrhea","Changes Vitamin D (25-hydroxyvitamin D) level"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Not a traditional drug phase: testing Vitamin D 4000IU daily for Polycystic Ovarian Syndrome in Adolescent Females","inPlainEnglish":"This study is a double blind, dummy treatment (placebo) controlled, randomly assigned trial of study subjects with PCOS and low vitamin D to 2 groups- dummy treatment (placebo) and vitamin D replacement. Participants and investigators will be blinded to treatment modality until the end of the trial period","whoItsFor":["Ages 13 Years to 21 Years","Women only","\\- Postmenarchal adolescent females aged 13-21 who meet modified Rotterdam criteria for PCOS, with a serum vitamin D level between 6-29 ng/mL"],"whoShouldSkip":["Other causes for hyperandrogenism,","Chronic renal diseases,","Acquired or inherited calcium and vitamin D metabolic disorders"],"whatHappens":"If you join, the listed intervention(s) are Vitamin D 4000IU daily, or Placebo. The registry lists allocation as randomized. This study is a double blind, dummy treatment (placebo) controlled, randomly assigned trial of study subjects with PCOS and low vitamin D to 2 groups- dummy treatment (placebo) and vitamin D replacement.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.792Z"},{"nctId":"NCT04362150","title":"Long-term Impact of Infection With Novel Coronavirus (COVID-19)","officialTitle":"Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data. LIINC specimens will be used to examine multiple questions involving the virologic, immunologic, and host factors involved in COVID-19, with a focus on understanding variability in the long-term immune response between individuals.","conditions":["COVID"],"keywords":["COVID-19","coronavirus","SARS-CoV-2","Long COVID","post-acute sequelae of SARS-CoV-2"],"interventions":[],"enrollment":800,"startDate":"2020-04-21","completionDate":"2030-12-31","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Willing and able to provide written informed consent, and\n2. Age \\>/= 18 years, and\n3. A history of SARS-CoV-2 infection, as evidenced by:\n\n   1. Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or\n   2. Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,\n4. And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier.\n\nExclusion Criteria:\n\n1. Self-reported or documented chronic anemia with hemoglobin \\< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.\n2. Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.\n3. Active drug or alcohol use or dependence that, in the opinion of the Principal Investigator, would interfere with adherence to study requirements or to give informed consent.","locations":[{"facility":"Zuckerberg San Francisco General Hospital (ZSFG)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily A Fehrman, MPH","phone":"(650) 761-2163","email":"emily.fehrman2@ucsf.edu"},{"name":"Michael J Peluso, MD","phone":"415-476-9363","email":"michael.peluso@ucsf.edu"}],"primaryOutcomes":["Participant age","Participant sex","Participant race/ethnicity","Proportion of participants previously hospitalized."],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Long-term Impact of Infection With Novel Coronavirus (COVID-19)","inPlainEnglish":"LIINC is a study of volunteers who were previously infected with SARS-CoV-2 (also known as novel coronavirus or COVID-19) who have recovered from acute infection. The study is designed to provide a specimen bank of samples with carefully characterized clinical data.","whoItsFor":["Ages 18 Years to 100 Years","Age \\>/= 18 years, and","A history of SARS-CoV-2 infection, as evidenced by:","Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid amplification test or by serologic testing when this becomes available, or","Reference by the participant to a laboratory test performed on respiratory tract secretions or blood, fingerstick, or saliva test that was reported to the participant to be positive for SARS-CoV-2 or COVID-19 infection,","And a period of 21 days or more has elapsed since the first positive test or symptoms preceding the first positive test, whichever is earlier"],"whoShouldSkip":["Self-reported or documented chronic anemia with hemoglobin \\< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 800 people at San Francisco. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.245Z"},{"nctId":"NCT04363684","title":"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)","officialTitle":"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.","conditions":["Frontotemporal Lobar Degeneration (FTLD)","Progressive Supranuclear Palsy (PSP)","Corticobasal Degeneration (CBD)","Behavioral Variant Frontotemporal Dementia (bvFTD)","Semantic Variant Primary Progressive Aphasia (svPPA)","Nonfluent Variant Primary Progressive Aphasia (nfvPPA)","FTD With Amyotrophic Lateral Sclerosis (FTD/ALS)","Amyotrophic Lateral Sclerosis","Oligosymptomatic PSP (oPSP)","C9orf72","GRN Related Frontotemporal Dementia","MAPT Gene Mutation","TBK1 Gene Mutation","Oligosymptomatic Progressive Supranuclear Palsy"],"keywords":[],"interventions":[],"enrollment":2100,"startDate":"2020-03-01","completionDate":"2030-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Longitudinal Arm Inclusion Criteria\n\nFamilial FTLD (f-FTLD) participants (either is acceptable):\n\n* members of families in whom at least one member has a known disease-associated mutation in one of the major genes that cause f-FTLD: MAPT, GRN, C9orf72 (or other rare genes)\n* an autosomal dominant family history of a FTLD syndrome (without a known gene) verified by medical record review or well-documented family history including family members with a medical history consistent with FTLD or a related disorder.\n\nSporadic FTLD (s-FTLD) participants:\n\nSporadic participants should be symptomatic with no known family history nor a genetic mutation indicating f-FTLD. All sporadic participants must have an FTLD syndrome as a referring diagnosis; those determined by ALLFTD clinicians to have non-FTLD diagnoses will be excluded from longitudinal visits, but their baseline visit will be included in comparative datasets. For inclusion in the longitudinal follow-up, participants should meet research criteria for one of the following FTLD syndromes:\n\n* Progressive Supranuclear Palsy (PSP)\n* Semantic variant Primary Progressive Aphasia (svPPA)\n* Nonfluent variant Primary Progressive Aphasia (nfvPPA)\n* Corticobasal Degeneration (CBD)/Corticobasal Syndrome (CBS)\n* Behavioral variant Frontotemporal dementia (bvFTD)\n* Frontotemporal Dementia with Amyotrophic Lateral Sclerosis (FTD/ALS)\n\nBiofluid-Focused Arm Inclusion Criteria\n\nParticipants enrolled in the biofluid arm may be either f-FTLD or s-FTLD. All general inclusion criteria apply. Participants should meet research criteria (as specified above) for any FTLD syndrome or meet familial FTLD inclusion criteria. Because the biofluid arm participants do not undergo the same detailed clinical and functional assessments required for the longitudinal arm, participants may be included regardless of primary language, as long as an appropriately translated consent is available.\n\nExclusion Criteria:\n\n* Known presence of a structural brain lesion (e.g. tumor, cortical infarct) that could reasonably explain symptoms in a symptomatic participant.\n* Known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or biomarker evidence for Alzheimer's disease as a cause of the clinical syndrome.\n* A previous history of Korsakoff encephalopathy, severe alcohol dependence (within 5 years of onset of dementia), frequent alcohol or other substance intoxication, or other neurological disorder.\n* Evidence through history or laboratory testing of uncorrected B12 deficiency (B12 \\< 95% of local laboratory's normal value), unregulated hypothyroidism (TSH \\>150% of normal), HIV positive, renal failure (creatinine \\> 2), liver failure (ALT or AST \\> two times normal), respiratory failure that requires supplemental oxygen, large confluent white matter lesions, significant systemic medical illnesses such as deteriorating cardiovascular disease.\n* Current medication likely to affect CNS functions in the opinion of the site PI.\n* In the site investigator's opinion, the participant cannot complete sufficient key study procedures. The participant may be enrolled into the biofluid-focused arm if they can tolerate a blood draw and short clinical exam, but must be able to complete at least 75% of study procedures for enrollment into the longitudinal arm.","locations":[{"facility":"University of Alabama Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Denver","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NIH","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washinton University in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina, Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Case Western Reserve Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nantz National Alzheimer Center Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT San Antonio Health Science Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Toronto","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Leah K Forsberg, PhD","phone":"507-293-9577","email":"forsberg.leah@mayo.edu"},{"name":"Hilary Heuer, PhD","phone":"415-476-6743","email":"hilary.heuer@ucsf.edu"}],"primaryOutcomes":["Change in Brain Volumes","Change in neuropsychological battery","Change in Multidomain Impairment Rating (MIR) Scale"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","los-angeles-california","san-diego-california","san-francisco-california","denver-colorado","jacksonville-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","baltimore-maryland","bethesda-maryland","boston-massachusetts","ann-arbor-michigan","rochester-minnesota","st-louis-missouri","new-york-new-york","chapel-hill-north-carolina","cleveland-ohio","philadelphia-pennsylvania","nashville-tennessee","houston-texas","san-antonio-texas","seattle-washington","vancouver-canada","toronto-canada"],"enrichment":{"headline":"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD)","inPlainEnglish":"ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) represents the formalized integration of ARTFL (U54 NS092089; funded through 2019) and LEFFTDS (U01 AG045390; funded through 2019) as a single North American research consortium to study FTLD for 2019 and beyond.","whoItsFor":["Ages 18 Years to any","Familial FTLD (f-FTLD) participants (either is acceptable):","members of families in whom at least one member has a known disease-associated mutation in one of the major genes that cause f-FTLD: MAPT, GRN, C9orf72 (or other rare genes)","an autosomal dominant family history of a FTLD syndrome (without a known gene) verified by medical record review or well-documented family history including family members with a medical history consistent with FTLD or a related disorder","Sporadic FTLD (s-FTLD) participants:","Progressive Supranuclear Palsy (PSP)","Semantic variant Primary Progressive Aphasia (svPPA)","Nonfluent variant Primary Progressive Aphasia (nfvPPA)"],"whoShouldSkip":["Known presence of a structural brain lesion (e.g. tumor, cortical infarct) that could reasonably explain symptoms in a symptomatic participant","Known presence of an Alzheimer's disease causing mutation in PSEN1, PSEN2 or APP; or biomarker evidence for Alzheimer's disease as a cause of the clinical syndrome","A previous history of Korsakoff encephalopathy, severe alcohol dependence (within 5 years of onset of dementia), frequent alcohol or other substance intoxication, or other neurological disorder","Current medication likely to affect CNS functions in the opinion of the site PI"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,100 people at 26 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.611Z"},{"nctId":"NCT04372108","title":"A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis","officialTitle":"An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen Scientific Affairs, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).","conditions":["Crohn Disease","Colitis, Ulcerative"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ustekinumab"},{"type":"DRUG","name":"Other Biologic Therapies"}],"enrollment":1536,"startDate":"2021-06-24","completionDate":"2029-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period\n* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs. Gaps in enrollment of ≤30 days will be considered continuous enrollment\n\nExclusion Criteria:\n\n* Participants below 18 years of age on the exposure index date\n* Participants who do not meet the definition for CD or UC prior to or on the exposure index date\n* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \\[NMSC\\]) at any time prior to or on the exposure index date\n* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date\n* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded","locations":[{"facility":"BAMC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Incidence Rate for Malignancy","Time from Treatment Initiation to First Diagnosed Malignancy"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: testing Ustekinumab for Crohn Disease","inPlainEnglish":"This study wants to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).","whoItsFor":["Ages 18 Years to any","Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period","Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs. Gaps in enrollment of ≤30 days will be considered continuous enrollment"],"whoShouldSkip":["Participants below 18 years of age on the exposure index date","Participants who do not meet the definition for CD or UC prior to or on the exposure index date","Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \\[NMSC\\]) at any time prior to or on the exposure index date","Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date","In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,536 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.896Z"},{"nctId":"NCT04375280","title":"Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort","officialTitle":"Evaluation of Impaired Mobility in Chronic Illness Constitution of a Cohort","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Clermont-Ferrand","sponsorClass":"OTHER","summary":"Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern. Therefore, the exploration of locomotor deficiencies, physical capacities and metabolism of patients with chronic illnesses constitutes a major challenge both for the treatment of causal pathologies, as well as for evaluating the impact of therapeutic interventions, the benefit of which will be an improvement in physical capacities and ultimately mobility. In view of the hypothesis of an increase in the prevalence of mobility disorders in this population, this approach is part of a logic of screening and improving the effectiveness of the care of these patients with a multidisciplinary evaluation of individual risks. The EVALMOB protocol was designed in order to try to determine a standard profile of \"dysmobility\" in patients with chronic illness","conditions":["Joint Osteoarthritis","Atherosclerosis of the Distal Arteries, Without Gangrene","Parkinson Disease","Chronic Obstructive Pulmonary Disease, Unspecified","Obesity, Unspecified"],"keywords":["Prevention","Mobility","Altered mobility","Risk factors","Chronic illness","Chronic pathologies","Physical capacities","Physical test","Activity limitations"],"interventions":[{"type":"OTHER","name":"Development of a screening algorithm designed to determine a \"dysmobility\" profile in patients with chronic illness."}],"enrollment":5000,"startDate":"2020-08-27","completionDate":"2035-08-26","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Man or woman aged 18 to 90.\n* Patients with chronic pathology contributing to impaired mobility.\n* Volunteers who have given their written consent.\n* Affiliated to French health care system (for France)\n\nExclusion Criteria:\n\n* Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.).\n* People with poorly controlled or unstable cardiovascular disease.\n* Major osteoarticular or neurological problems completely preventing the proper performance of the various tests.\n* Non-autonomous patient\n* Persons under guardianship, curatorship, deprived of liberty or safeguarding justice.\n* People excluded from another study.\n* Pregnant or lactating women.","locations":[{"facility":"Chu Clermont Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Laclautre","phone":"334.73.754.963","email":"promo_interne_drci@chu-clermontferrand.fr"}],"primaryOutcomes":["dismobility score calculated from the results reported in secondary outcomes","dismobility score calculated from the results reported in secondary outcomes","dismobility score calculated from the results reported in secondary outcomes","dismobility score calculated from the results reported in secondary outcomes","dismobility score calculated from the results reported in secondary outcomes"],"hasResults":false,"conditionSlugs":["parkinson","obesity","osteoarthritis","copd"],"drugSlugs":[],"locationSlugs":["clermont-ferrand-france"],"enrichment":{"headline":"Not a traditional drug phase: Development of a screening algorithm designed to determine a \"dysmobility\" profile in patients with chronic illness. for Joint Osteoarthritis","inPlainEnglish":"Chronic illness is a public health issue and mobility loss is frequent in this population. Among its' multiple physical and psychological consequences, increased mortality and cardiovascular morbidity seem the main concern.","whoItsFor":["Ages 18 Years to 90 Years","Man or woman aged 18 to 90","Patients with chronic pathology contributing to impaired mobility","Volunteers who have given their written consent","Affiliated to French health care system (for France)"],"whoShouldSkip":["Patients suffering from progressive psychiatric pathologies (active psychosis, hallucinations, etc.) or the presence of another serious unstabilized pathology (decompensated heart failure, progressive terminal cancer, etc.)","People with poorly controlled or unstable cardiovascular disease","Major osteoarticular or neurological problems completely preventing the proper performance of the various tests","Non-autonomous patient","Persons under guardianship, curatorship, deprived of liberty or safeguarding justice","People excluded from another study","Pregnant or lactating women"],"whatHappens":"If you join, the listed intervention(s) are Development of a screening algorithm designed to determine a \"dysmobility\" profile in patients with chronic illness.. The registry lists allocation as na. Chronic illness is a public health issue and mobility loss is frequent in this population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 5,000 people at Clermont-Ferrand. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.670Z"},{"nctId":"NCT04394871","title":"Clinical Manifestations and Biomarkers in Amyotrophic Lateral Sclerosis Type 4 and Other Inherited Neurological Disorders of RNA Processing","officialTitle":"An Observational Study to Assess Clinical Manifestations and Biomarkers in Amyotrophic Lateral Sclerosis Type 4, Other Inherited Neurological Disorders With RNA Processing Defects, and Other Neurological Diseases With a Gain of Function Mechanism.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nAmyotrophic lateral sclerosis type 4 (ALS4) is an inherited motor neuron disease. People with ALS4 have a change in the amount of RNA and DNA that bind together. This binding of RNA with DNA forms units called R-loops. Researchers want to learn how R-loops are related to ALS4. To do this, they will study people with inherited neurological conditions that may affect R-loop levels. These include ALS4, progressive external opthalmoplegia with mitochondrial deletions (PEOB2), Aicardi-Goutieres syndrome (AGS), and ataxia and oculomotor apraxia type 2 (AOA2).\n\nObjective:\n\nTo learn how the binding of RNA with DNA (R-loops) is related to neurological disease.\n\nEligibility:\n\nPeople age 5 and older with ALS4, PEOB2, AGS, and AOA2. Healthy relatives and nonrelatives are also needed.\n\nDesign:\n\nParticipants may be screened with a review of x-rays and other medical records.\n\nHealthy relative and nonrelative participants will have 1 visit. All other participants will have 4 visits over 3 years.\n\nAt visits, participants will undergo some or all of the following:\n\nMedical history\n\nPhysical exam\n\nTests of muscle strength and volume and physical function\n\nBlood tests\n\nPregnancy test (for some females)\n\nSkin biopsy of forearm\n\nMagnetic resonance imaging (MRI)\n\nDual x-ray absorptiometry (DEXA).\n\nSome tests are optional.\n\nThe MRI uses a magnetic field and radio waves to take pictures. Participants will lie on a table that slides in and out of the scanner. The scanner makes noise. They will get earplugs.\n\nThe DEXA scan uses x-rays to take pictures.\n\nMRI and DEXA will be used to measure muscle, fat, and lean body mass.\n\n...","conditions":["Amyotrophic Lateral Sclerosis Type 4","Inherited Neurological Disorders of RNA Processing"],"keywords":["Natural History Study","Biomarker Development","Natural History"],"interventions":[],"enrollment":330,"startDate":"2020-12-14","completionDate":"2030-12-25","sex":"ALL","minAge":"5 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nALS4 RNA metabolism inclusion criteria:\n\n* Age 5 or above\n* Genetic diagnosis of ALS4 (heterozygous mutation in SETX)\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study\n* Capacity to consent (adults) or assent (pediatric subjects) to the study\n\nDisease control inclusion criteria:\n\n* Age 5 or above\n* Genetic diagnosis of RNA processing defect mutation (RNaseH1, RNaseH2, recessive mutations in SETX)\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study\n* Capacity to consent (adults) or assent (pediatric subjects) to the study\n\nRelated, unaffected healthy control inclusion criteria:\n\n* Age 5 or above\n* Family history (first, second, or third degree relative) of RNA processing defect mutation (RNaseH1, RNaseH2, heterozygous or recessive mutations in SETX)\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study\n* Capacity to consent (adults) or assent (pediatric subjects) to the study\n\nUnrelated, healthy control inclusion criteria:\n\n* Age 5 or above\n* Able to communicate well with the investigator, to understand and comply with the requirements of the study\n* Capacity to consent (adults) or assent (pediatric subjects) to the study\n\nGain of function inclusion criteria:\n\n* Age 5 or above\n* Genetic diagnosis of mutation resulting in a gain of function mechanism (for example, heterozygous mutations in SETX or heterozygous mutations in KCC3)\n* Able to communicate well with the investigator, to understand and comply with the requirements of the studyCapacity to consent (adults) or assent (pediatric subjects) to the study\n* Capacity to consent (adults) or assent (pediatric subjects) to the study\n\nEXCLUSION CRITERIA:\n\nALS4 RNA metabolism exclusion criteria:\n\n* Patients with known claustrophobia, presence of pacemaker, ferromagnetic material in their body, or any other condition that would preclude MRI assessments\n* Pregnancy\n\nNote: An Adult RNA metabolism ALS4 Patient who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\<70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants\n\n  * Disease control exclusion criteria:\n\n    --Pregnancy\n  * Related, unaffected healthy control exclusion criteria:\n\n    * Diagnosis of neuromuscular disease or weakness on physical examination\n    * Pregnancy\n\nNote: An Adult Related, Unaffected Healthy Control who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\<70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants\n\n  * Unrelated, healthy control exclusion criteria:\n\n    * Diagnosis of neuromuscular disease or weakness on physical examination\n    * Patients with known claustrophobia, presence of pacemaker, ferromagnetic material in their body, or any other condition that would preclude MRI assessments\n  * Pregnancy\n\nNote: An Adult Unrelated, Healthy Control who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\<70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants\n\nGain of function exclusion criteria:\n\n-Pregnancy\n\nNote: An Adult Gain of Function patient who meets any of the following criteria will be excluded from the lumbar puncture procedure:\n\n* PT/PTT values that are prolonged greater than or equal to 3 seconds from the upper limit of normal (including treatment with oral and parenteral anticoagulants)\n* INR greater than or equal to 1.5, thrombocytopenia (\\<70,000), or abnormal bleeding time or platelet dysfunction\n* History of a bleeding disorder\n* Use of anticoagulants","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Angela D Kokkinis, R.N.","phone":"(301) 451-8146","email":"akokkinis@mail.cc.nih.gov"},{"name":"Christopher Grunseich, M.D.","phone":"(301) 402-5423","email":"grunseichc@mail.nih.gov"}],"primaryOutcomes":["Disease progression as measured by thigh muscle volume and other study measures"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Clinical Manifestations and Biomarkers in Amyotrophic Lateral Sclerosis Type 4 and Other Inherited Neurolog…","inPlainEnglish":"Background: Amyotrophic lateral sclerosis type 4 (ALS4) is an inherited motor neuron disease. People with ALS4 have a change in the amount of RNA and DNA that bind together.","whoItsFor":["Ages 5 Years to 120 Years","ALS4 RNA metabolism who can join:","Genetic diagnosis of ALS4 (heterozygous mutation in SETX)","Able to communicate well with the investigator, to understand and comply with the requirements of the study","Capacity to consent (adults) or assent (pediatric subjects) to the study","Disease control who can join:","Genetic diagnosis of RNA processing defect mutation (RNaseH1, RNaseH2, recessive mutations in SETX)","Related, unaffected healthy control who can join:"],"whoShouldSkip":["ALS4 RNA metabolism"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 330 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.620Z"},{"nctId":"NCT04396873","title":"PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","officialTitle":"Phase 1 Study: PET Imaging of Cyclooxygenases in Neurodegenerative Brain Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nAbout 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder. Many studies have found that inflammation in the brain contributes to these diseases. Researchers want to find a better way to measure this inflammation.\n\nObjective:\n\nTo learn whether COX-1 and/or COX-2 is elevated in the brains of individuals with neurodegenerative brain disease compared to healthy volunteers.\n\nEligibility:\n\nAdults age 18 years and older in good general health who have an adult-onset neurodegenerative dementia, such as AD, FTD, corticobasal syndrome, Huntington s disease, or MCI, ALS and healthy adult volunteers enrolled in protocols 01-M-0254 or 17-M-0181.\n\nDesign:\n\nParticipants will be screened with medical history, physical exam with vital signs, and lab tests. They will have a neuropsychological testing. Their heart function will be measured.\n\nParticipants will have a magnetic resonance imaging (MRI) scan. The MRI scanner is a metal tube surrounded by a strong magnetic field. Participants will lie on a table that slides in and out of the tube. The machine makes noise. Participants will get earplugs.\n\nParticipants will have 2 PET scans. They will be injected with the study drugs through an intravenous catheter placed in an arm vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. A plastic mask will be molded to their head to keep them from moving. A thin plastic tube will be put into an artery at the wrist or elbow crease area. This will be used to draw blood during the scan.\n\nParticipants will have 2-5 study visits. Participation lasts 1 week to 4 months, depending on scheduling.","conditions":["Parkinson's Disease","Dementia","Alzheimer's Disease","ALS","Mild Cognitive Impairment"],"keywords":["PET Imaging","PD","Inflammation","Dementia","Cyclooxygenase-2","ALS","MCI"],"interventions":[{"type":"DRUG","name":"11C-MC1"},{"type":"DRUG","name":"11C-PS13"},{"type":"DRUG","name":"18f-florbetaben"}],"enrollment":184,"startDate":"2021-08-17","completionDate":"2029-04-11","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients: In order to be eligible to participate in this study, patients must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n3. Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease.\n4. Be in good general health as evidenced by medical history and physical examination.\n5. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n6. Agree to adhere to the lifestyle considerations.\n\nHealthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:\n\n1. Aged 18 or older.\n2. Female participants of childbearing potential must be using a medically acceptable means of contraception\n3. Able provide informed consent.\n4. Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n5. Be enrolled in 01-M-0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17-M-0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies\n6. Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n7. Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n1. Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two-times the upper limit or even lower values in the investigator s judgment. Creatinine level \\>1.3 mg/dL\n2. Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n3. Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding.\n4. Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n5. Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n6. Are unable to travel to the NIH.\n7. Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n8. Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the patient and/or caregiver during the screening visit.\n9. Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs function of daily life.\n10. Participants should not be under treatment with Aduhelm, nor should they have been treated in the past.\n11. Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n12. Pregnancy\n13. HIV infection\n14. Be NIMH staff or an NIH employee who is a subordinate/relative/co-worker of the investigators.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tara N Turon, C.R.N.P.","phone":"(301) 827-6599","email":"tara.turon@nih.gov"},{"name":"Robert B Innis, M.D.","phone":"(301) 594-1368","email":"robert.innis@nih.gov"}],"primaryOutcomes":["Measure the concentration of radioligands"],"hasResults":false,"conditionSlugs":["alzheimer","parkinson","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing 11C-MC1 for Parkinson's Disease","inPlainEnglish":"Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder.","whoItsFor":["Ages 18 Years to 99 Years","Patients: In order to be eligible to participate in this study, patients must meet all of the following criteria:","Have been diagnosed by a neurologist or psychiatrist with MCI, ALS, PD, or an adult onset neurodegenerative dementia, such as AD (including amyloid negative subjects), FTD, corticobasal syndrome, or Huntington s disease","Be in good general health as evidenced by medical history and physical examination","Have their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists","Agree to adhere to the lifestyle considerations","Healthy volunteers: In order to be eligible to participate in this study, healthy volunteer subjects must meet all of the following criteria:","Female participants of childbearing potential must be using a medically acceptable means of contraception"],"whoShouldSkip":["Both patients and healthy volunteers who meet any of the following criteria will be excluded from participation in this study:","Subjects should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAID) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month","Contraindications to ketoprofen, such as hypersensitivity to ketoprofen or history of upper or lower gastrointestinal bleeding","Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities","Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy)","Are unable to travel to the NIH","Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits"],"whatHappens":"If you join, the listed intervention(s) are 11C-MC1, 11C-PS13, or 18f-florbetaben. The registry lists allocation as na. Background: About 5 million adults in the U.S.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 184 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.675Z"},{"nctId":"NCT04410796","title":"Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers","officialTitle":"A Phase 2 Randomized Study of Osimertinib Versus Osimertinib Plus Chemotherapy for Patients With Metastatic EGFR-Mutant Lung Cancers That Have Detectable EGFR-Mutant cfDNA in Plasma After Initiation of Osimertinib","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.","conditions":["Metastatic Non-small Cell Lung Cancer"],"keywords":["EGFR-Mutant Lung Cancers","Osimertinib","Osimertinib Plus Chemotherapy","20-011"],"interventions":[{"type":"DRUG","name":"Osimertinib"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"}],"enrollment":571,"startDate":"2020-05-28","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria: Inital\n\n* Age ≥ 18 years\n* Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution\n* Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA\n* Either have not started a prior EGFR TKI therapy or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy \\> 6 months prior to study start is acceptable)\n* Measurable (RECIST 1.1) indicator lesion not previously irradiated with measurable disease determined per treating investigator. If a patient has already started on osimertinib there must be available pre-osimertinib baseline tumor assessments , or tumor assessments within +7 days of Osimertinib start, to be utilized for RECIST 1.1 assessment.\n* Karnofsky performance status (KPS)≥70%,\n* Ability to swallow oral medications\n* Adequate organ function (use of G-CSF and/or transfusion to meet these criteria are not allowed)\n\n  * Hemoglobin ≥ 9 g/dL\n  * Platelets ≥ 150,000mm\\^3 or 150 x 10\\^9/L\n  * AST, ALT ≤ 2.5 x ULN with no liver metastases or \\< 5x ULN with the presence of liver metastases\n  * Total bilirubin ≤ 1.5 x ULN if no liver metastases or \\< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  * Absolute neutrophil count (ANC) ≥ 1500 cells/mm\\^3\n  * Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml/min calculated by Cockcroft and Gault equation\n  * Creatinine clearance ≥ 60 mL/min calculated by Cockcroft and Gault equation\n* Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential:\n\n  * Female subjects should be using highly effective contraceptive measures, and must have a negative pregnancy test and not be breast-feeding prior to start of dosing through 6 weeks after discontinuing the study drug if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:\n  * Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments\n  * Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution\n  * Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation\n  * Male subjects should be willing to use barrier contraception and avoid sperm donation prior to the start of dosing through 4 months of discontinuing the study drug\n\nExclusion Criteria: Initial\n\n* Pregnant or lactating women\n* Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.\n* Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.\n* Any evidence of clinically significant interstitial lung disease\n* Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater\n* Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.\n* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy- related neuropathy\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial\n* active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n* Screening for chronic conditions is not required.\n* In patients with resolved or chronic hepatitis B infection (inactive carrier state) or active controlled HBV infection on treatment with osimertinib\n\n  * Recommend monthly monitoring of ALT/AST, HBV DNA levels and HBsAg (if negative at baseline)\n  * Where liver signs and symptoms of viral reactivation appear (HBV DNA levels exceeding 10-fold from baseline or ≥100 IU/ml (if baseline HBV DNA levels are undetectable) or conversion of HBsAg negative to positive):\n  * Expert hepatologist/specialist oversight of the patient is required\n  * Consider interruption or discontinuation of study treatment, based on riskbenefit assessment\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (QTc) \\> 470 msec where QT interval is corrected for heart rate using Frederica's formula (QTcF).\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n  * Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/Plasma potassium \\<LLN, Serum/Plasma Magnesium \\<LLN; Serum/Plasma Calcium \\<LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes.If concomitant medication can not be discontinued, please notify and confirm with MSK PI prior to enrollment.\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n* History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n\nInclusion Criteria: Randomization\n\n* Patients with detectable plasma EGFR mutations at C2D1\n* Karnofsky performance status (KPS) ≥ 70%\n* Adequate organ function\n\n  * Hemoglobin ≥ 9 g/dL\n  * Platelets ≥ 100,000mm\\^3 or 100 x 10\\^9/L\n  * Creatinine ≤ ULN OR calculated creatinine clearance ≥ 60ml/min\n  * AST, ALT ≤ 3x ULN with no liver metastases or ≤ 5x ULN with the presence of liver metastases\n  * Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases\n  * Absolute neutrophil count (ANC) ≥ 1500 cells/mm3Must have at least stable disease per RECIST 1.1 assessment prior to initiating chemotherapy at C4D1\n  * Eligibility testing (KPS, bloodwork) should be tested at C3D1. If the subject's evaluation does not meet eligibility criteria, any result obtained between C3 and C4 can be used\n\nPlease note: All 'Initial' Exclusion Criteria must be re-confirmed prior to randomization, except for the cardiac criteria related to the ECG. The ECG does not need to be repeated for patients screening for Randomization.","locations":[{"facility":"UC Davis Cancer Center (Data Collection Only)","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Hopkins Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital (Data Collection Only)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Meridian Health","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Commack (Limited protocol activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (Limited protocol activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Columbia University (Data Collection Only)","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All protocol activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD ANDERSON CANCER CENTER (Data Collection Only)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington (Data Collection Only)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Helena Yu, MD","phone":"646-608-2252","email":"yuh@mskcc.org"},{"name":"Gregory Riely, MD, PhD","phone":"646-608-3913","email":""}],"primaryOutcomes":["Determine the progression-free survival"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["sacramento-california","san-francisco-california","tampa-florida","baltimore-maryland","boston-massachusetts","basking-ridge-new-jersey","hackensack-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","nashville-tennessee","houston-texas","seattle-washington"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Metastatic Non-small Cell Lung Cancer","inPlainEnglish":"This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer.","whoItsFor":["Ages 18 Years to any","Biopsy proven metastatic non-small cell lung cancer, confirmed at enrolling institution","Somatic activating mutation in EGFR in pre-treatment tumor biopsy/ cytology from pleural fluid or cfDNA","Karnofsky performance status (KPS)≥70%,","Ability to swallow oral medications","Adequate organ function (use of G-CSF and/or transfusion to meet these criteria are not allowed)","Hemoglobin ≥ 9 g/dL","Platelets ≥ 150,000mm\\^3 or 150 x 10\\^9/L"],"whoShouldSkip":["Pregnant or lactating women","Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib","Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib","Any evidence of clinically significant interstitial lung disease","Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater","Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment, with the exception of alopecia and grade 2 prior platinum-therapy- related neuropathy","Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib, Carboplatin, or Pemetrexed. The registry lists allocation as randomized. This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 571 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.688Z"},{"nctId":"NCT04420702","title":"Diffusion Basis Spectrum Imaging of the Prostate","officialTitle":"Diffusion Basis Spectrum Imaging of the Prostate: A Virtual Biopsy to Accurately Diagnose Prostate Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.","conditions":["Prostate Cancer"],"keywords":["Prostate Cancer"],"interventions":[{"type":"DEVICE","name":"MRI with DBSI analysis"}],"enrollment":500,"startDate":"2020-02-27","completionDate":"2027-05-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Over 18 years of age and willing and able to provide informed consent.\n* Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care (\"early detection cohort\")\n* Including those men with:\n\n  * an elevated PSA and no prior biopsy\n  * an elevated PSA and a negative prior biopsy\n* Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care (\"active surveillance cohort\")\n\nExclusion Criteria:\n\n* Patients with any clinical contraindication to MRI\n\n  \\*Including but not limited to:\n  * Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators\n  * Those with cochlear implants\n  * Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)\n  * Those who cannot lie flat for over 1 hour\n* Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)","locations":[{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hongyu An, M.D., Ph.D.","phone":"314-362-5805","email":"hongyuan@wustl.edu"},{"name":"Alex Klim","phone":"314-747-9781","email":"klima@wustl.edu"}],"primaryOutcomes":["Area under the curve (AUC) comparison from biopsy and DBSI","Receiver operating characteristic (ROC) comparison from biopsy to DBSI","Prostate sector analysis as measured by comparison of the highest Gleason score from each of the 10 biopsy sectors to the DBSI predicted pathology from each sector"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: MRI with DBSI analysis for Prostate Cancer","inPlainEnglish":"Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.","whoItsFor":["Ages 18 Years to any","Men only","Patients with no prior diagnosis of prostate cancer, who are planning to undergo prostate biopsy as clinical standard of care (\"early detection cohort\")","Including those men with:","an elevated PSA and no prior biopsy","an elevated PSA and a negative prior biopsy","Patients with a prior diagnosis of prostate cancer, who are currently managed with active surveillance, who are planning to undergo biopsy as clinical standard of care (\"active surveillance cohort\")"],"whoShouldSkip":["Patients with any clinical contraindication to MRI","\\*Including but not limited to:","Those with metallic implants, such as pacemakers or implantable cardioverter-defibrillators","Those with cochlear implants","Those with claustrophobia not relieved with medications (patients with claustrophobia who do not need medications for the scan or whose claustrophobia can be managed with medication, are eligible to participate)","Those who cannot lie flat for over 1 hour","Patients with prior prostate surgery for prostate cancer (e.g. radical prostatectomy, focal ablation)"],"whatHappens":"If you join, the listed intervention(s) are MRI with DBSI analysis. The registry lists allocation as randomized. Diffusion Basis Spectrum Imaging (DBSI) represents a potential leap forward in improving prostate cancer early detection: a non-invasive and accurate imaging test for clinically significant prostate cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 500 people at St Louis. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.314Z"},{"nctId":"NCT04421248","title":"Biomarker Validation in Motor System Physiology in Attention Deficit Hyperactivity Disorder","officialTitle":"Anomalous Motor System Physiology in Attention Deficit Hyperactivity Disorder: Biomarker Validation and Modeling Domains of Function","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"Donald Gilbert, MD, MS, FAAN, FAAP","sponsorClass":"OTHER","summary":"Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity. They are at substantially increased risk for long-term difficulties into adulthood, including academic underachievement, substance abuse, and criminal behavior. The diagnosis of ADHD, which is based on subjective ratings by parents and teachers, likely results from multiple different, overlapping differences in circuits of the brain responsible for attention and impulse control. However, we do not have any scientific or clinical tests that allow us to understand these circuits. In an effort to improve ADHD outcomes, we have used a technology called Transcranial Magnetic Stimulation (TMS) to identify highly reliable measurements of brain function. We have identified two very promising measures that are abnormal in children with ADHD and, importantly, also predict the severity of ADHD behaviors. The goal of this project is to determine if these two TMS measurements could be used to help better guide ADHD treatment. To do this, we will perform three investigations in 8 to 12 year old children to determine: 1) test-retest reliability; 2) pharmacologic responsiveness; and 3) correlations with two domains of function relevant to ADHD: \"Cognitive Control\" and \"Emotional Valence.\" Through these investigations, we aim to determine whether these two TMS brain measures are reliable and meaningful enough to be used to help improve precision of individually-targeted and effective ADHD treatments.","conditions":["Attention Deficit Hyperactivity Disorder Combined"],"keywords":[],"interventions":[{"type":"DRUG","name":"Methylphenidate"},{"type":"DRUG","name":"Placebo"}],"enrollment":214,"startDate":"2020-09-01","completionDate":"2026-02-09","sex":"ALL","minAge":"8 Years","maxAge":"12 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Either gender, any race, ethnicity or socioeconomic status\n* Currently between 8 years 0 months and 12 years, 11 months, 30 days\n* Willing to answer questions about ADHD and related diagnoses\n* For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures\n* For children with ADHD, willing to participate in the single dose, randomized crossover study to probe acute effects of methylphenidate on biomarkers\n* Right hand dominant (predominately right-handed)\n* Able to participate in and sign an informed consent\n* ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded.\n* Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview.\n\nExclusion Criteria:\n\n* Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder.\n* Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses.\n* For females, onset of menses, pregnancy.\n* Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers.\n* Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port.\n* Diagnosis of a speech/language disorder or a Reading Disability (RD).","locations":[{"facility":"Kennedy Krieger Institute","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Donald L Gilbert, MD","phone":"800-344-2462","email":"donald.gilbert@cchmc.org"},{"name":"Steve W Wu, MD","phone":"800-344-2462","email":"steve.wu@cchmc.org"}],"primaryOutcomes":["Transcranial Magnetic Stimulation (TMS)-evoked Short Interval Cortical Inhibition (SICI) Test-Retest Reliability","Transcranial Magnetic Stimulation (TMS)-evoked Task Related Up Modulation (TRUM) Test-Retest Reliability"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["baltimore-maryland","cincinnati-ohio"],"enrichment":{"headline":"Phase 4: testing Methylphenidate for Attention Deficit Hyperactivity Disorder Combined","inPlainEnglish":"Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood. Children with ADHD struggle in school due to problems with attention and high levels of impulsivity and hyperactivity.","whoItsFor":["Ages 8 Years to 12 Years","Either gender, any race, ethnicity or socioeconomic status","Currently between 8 years 0 months and 12 years, 11 months, 30 days","Willing to answer questions about ADHD and related diagnoses","For children with ADHD prescribed stimulant medications, willing to suspend taking medications as specified in the study procedures","Right hand dominant (predominately right-handed)","ADHD inclusion: The diagnosis of ADHD will be based on Diagnostic and Statistical Manual version 5 (DSM-5) criteria using standard rating scales and a structured diagnostic interview. Oppositional Defiant Disorder is permitted; Conduct disorder is excluded","Typically Developing (healthy control) inclusion: Free of ADHD or other developmental or psychiatric disorders based on DSM-5 criteria using standard rating scales and a structured diagnostic interview"],"whoShouldSkip":["Known diagnosis of mental retardation, cerebral palsy, Autism Spectrum Disorder, traumatic brain injury, brain tumor, epilepsy, or other serious neurological disorder","Major Depression, Bipolar Disorder, Conduct Disorder, Adjustment Disorder, other Anxiety Disorders, or other developmental psychiatric diagnoses","For females, onset of menses, pregnancy","Current use of antidepressants, non-stimulant ADHD medications, dopamine blocking agents, mood stabilizers","Implanted brain stimulator, vagal nerve stimulator, ventriculo-peritoneal shunt, cardiac pacemaker, or implanted medication port","Diagnosis of a speech/language disorder or a Reading Disability (RD)"],"whatHappens":"If you join, the listed intervention(s) are Methylphenidate, or Placebo. The registry lists allocation as randomized. Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurobehavioral disorder in childhood.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 214 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.657Z"},{"nctId":"NCT04458688","title":"Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis","officialTitle":"Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Wayne State University","sponsorClass":"OTHER","summary":"The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..","conditions":["Multiple Sclerosis, Relapsing-Remitting"],"keywords":["multiple sclerosis","ocrelizumab","magnetic resonance imaging (MRI)","optical coherence tomography angiography (OCTA)"],"interventions":[{"type":"OTHER","name":"Observation of Ocrelizumab as Treatment in RRMS Patients"}],"enrollment":80,"startDate":"2021-11-20","completionDate":"2025-07","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist.\n2. May be treatment naive, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months).\n3. Age 18 to 60 years old.\n4. Ethnicity: self-identified as African American or Caucasian.\n5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.\n6. EDSS from 0 to 6 (inclusive) at baseline visit.\n7. Able to give informed consent.\n8. Able to have MRI scans.\n\nExclusion Criteria:\n\n1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.\n2. Failed 2 or more DMTs.\n3. Treatment with immunosuppressant agents, such as chemotherapeutic agents.\n4. Claustrophobia.\n5. Allergy to contrast.\n6. Significant medical problems that the PI determines will interfere with the conduct of the study.\n7. Relapse or use of corticosteroids within 30 days prior to baseline visit.\n8. Pregnancy.\n9. History of kidney or liver insufficiency.\n10. History of malignancy.","locations":[{"facility":"Wayne State University","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zahid Latif","phone":"3139660473","email":"zahidlatif@wayne.edu"},{"name":"Kelly Jia","phone":"313-966-9407","email":"xjia@med.wayne.edu"}],"primaryOutcomes":["Magnetic Resonance Imaging (MRI) with contrast","Optical Coherence Tomography Angiography (OCTA)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["detroit-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Observation of Ocrelizumab as Treatment in RRMS Patients for Multiple Sclerosis, Relapsing-Remitting","inPlainEnglish":"The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..","whoItsFor":["Ages 18 Years to 60 Years","Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist","May be treatment who have not tried this kind of treatment before, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months)","Age 18 to 60 years old","Ethnicity: self-identified as African American or Caucasian","Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria","EDSS from 0 to 6 (inclusive) at baseline visit","Able to have MRI scans"],"whoShouldSkip":["Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab","Failed 2 or more DMTs","Treatment with immunosuppressant agents, such as chemotherapeutic agents","Allergy to contrast","Significant medical problems that the PI determines will interfere with the conduct of the study","Relapse or use of corticosteroids within 30 days prior to baseline visit","History of kidney or liver insufficiency"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Detroit. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.998Z"},{"nctId":"NCT04462770","title":"A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome","officialTitle":"A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Epygenix","sponsorClass":"INDUSTRY","summary":"This is a multicenter, Phase 3, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of clemizole hydrochloride (EPX-100) as adjunctive therapy in children and adult participants with Dravet syndrome (DS).","conditions":["Dravet Syndrome"],"keywords":["Clemizole hydrochloride","Convulsive seizure","Pediatric epilepsy","Dravet syndrome"],"interventions":[{"type":"DRUG","name":"Clemizole HCl"},{"type":"DRUG","name":"Placebo"}],"enrollment":150,"startDate":"2020-09-15","completionDate":"2027-04","sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Male and female participants 2 years and older at time of consent.\n2. Participant or parent/legally authorized representative (LAR) willing and able to provide written informed consent and assent (if applicable) prior to initiation of any study related procedures.\n3. Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:\n\n   * Onset of seizures prior to 18 months of age,\n   * Normal development at onset,\n   * History of at least one type of countable motor seizure (CMS),\n   * Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),\n   * Genetic mutation of the SCN1A gene must be documented.\n\nKey Exclusion Criteria:\n\n1. Known sensitivity, allergy, or previous exposure to clemizole HCl.\n2. Exposure to any investigational drug or device \\<90 days prior to Screening or plans to participate in another drug or device trial at any time during the study.\n3. Seizures secondary to illicit drug (this includes concomitant use of tetrahydrocannabinol \\[THC\\] and nonprescription cannabidiol preparations) or alcohol use, infection, neoplasm, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.\n4. Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose.\n5. Concurrent use of fenfluramine.\n6. Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Children's Hospital","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center","city":"San Francisco","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Yale School of Medicine - Yale-New Haven Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Nemours Foundation","city":"Wilmington","state":"Delaware","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Rare Disease Research FL","city":"Kissimmee","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Pediatric Neurology and Epilepsy Specialists","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta (CIRCA)","city":"Atlanta","state":"Georgia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Norton Children's Research Institute","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan- Mott Children's Hospital","city":"Ann Arbor","state":"Michigan","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Children's Nebraska","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Regional Epilepsy Group","city":"Hackensack","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Neurology Center for Epilepsy and Seizures","city":"Marlboro","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medical Center","city":"New 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Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin, Children's Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Conci Carpinella - Santa Rosa N° 748","city":"Córdoba","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Privado Kremer","city":"Córdoba","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Rivarola (GIEN SRL)","city":"San Luis","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitário da Universidade Estadual de Campinas - UNICAMP","city":"Campinas","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS","city":"São José do Rio Preto","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital São Paulo da Universidade Federal de Sao Paulo - Escola Paulista de Medicina UNIFESP-EPM","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Psiquiatria HC FMUSP","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UBC Children's Hospital Research Institute","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Eastern Ontario Research Institute Inc.","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto Western Hospital, University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Children's Hospital, Capital Medical University - PIN","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital - Daxing Campus","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Chongqing Medical University","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guangzhou Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Children's Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Guizhou Medical University","city":"Guiyang","state":"Guizhou","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wuhan Children's Hospital","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Children's Hospital","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xuzhou Children's Hospital","city":"Xuzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Provincial Children's Hospital - Donghu Campus","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xi'an Jiaotong University","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Shanghai - Ludinglu Campus","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Second University Hospital, Sichuan University - Huaxi Campus","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chengdu Women's and Children's Central Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital Zhejiang University School of Medicine - Hubin Campus","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tbilisi State Medical University, Givi Zhvania Academic, Clinic of Pediatry","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medi Club Georgia LLC","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Neurology and Neuropsychology LTD","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis University","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Debrecen","city":"Debrecen","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rainbow Children's Hospital","city":"Hyderabad","state":"Andhra Pradesh","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yashoda Hospitals Hitec City","city":"Hyderabad","state":"Andhra Pradesh","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Saachi Children's Hospital","city":"Surat","state":"Gujarat","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"KLES Dr Prabhakar Kore Hospital and Medical Research Centre","city":"Belagavi","state":"Karnataka","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute of Mental Health and Neurosciences (NIMHANS)","city":"Bengaluru","state":"Karnataka","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amrita Institute of Medical Sciences & Research Center","city":"Kochi","state":"Kerala","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"KEM Hospital Research Centre","city":"Pune","state":"Maharashta","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jaslok Hospital & Research Centre","city":"Mumbai","state":"Maharashtra","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central India Cardiology Hospital and Research Institute","city":"Nagpur","state":"Maharashtra","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"SRCC Children's Hospital","city":"Mahālakshmi","state":"Mumbai","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"All India Institute of Medical Sciences (AIIMS)","city":"New Delhi","state":"National Capital Territory of Delhi","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Christian Medical College","city":"Vellore","state":"Tamil Nadu","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center in Gdansk, Division of Developmental Neurology","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Centre Plejady","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mother and Child","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Infantil Universitario Niño Jesús","city":"Madrid","state":"Madrid Provincia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de la Santa Creu i Sant Pau","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiff and Vale University Health Board","city":"Cardiff","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital For Children","city":"London","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Krystle Rapchak","phone":"+1 (312) 847-1289","email":"clinicaltrials@harmonybiosciences.com"},{"name":"Eric Bauer","phone":"","email":"clinicaltrials@harmonybiosciences.com"}],"primaryOutcomes":["Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline","European Union: Percent Change in CMS-28 in the Maintenance Period Relative to Baseline"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","little-rock-arkansas","los-angeles-california","orange-california","san-francisco-california","new-haven-connecticut","wilmington-delaware","kissimmee-florida","winter-park-florida","atlanta-georgia","chicago-illinois","louisville-kentucky","ann-arbor-michigan","omaha-nebraska","hackensack-new-jersey","marlboro-new-jersey","new-york-new-york","durham-north-carolina","morrisville-north-carolina","winston-salem-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","memphis-tennessee","austin-texas","dallas-texas","salt-lake-city-utah","seattle-washington","milwaukee-wisconsin","buenos-aires-argentina","c-rdoba-argentina","san-luis-argentina","campinas-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","vancouver-canada","ottawa-canada","toronto-canada","beijing-china","chongqing-china","guangzhou-china","shenzhen-china","guiyang-china","wuhan-china","changsha-china","xuzhou-china","nanchang-china","changchun-china","xian-china","jinan-china","shanghai-china","chengdu-china","hangzhou-china","tbilisi-georgia","budapest-hungary","debrecen-hungary","hyderabad-india","surat-india","belagavi-india","bengaluru-india","kochi-india","pune-india","mumbai-india","nagpur-india","mah-lakshmi-india","new-delhi-india","vellore-india","gdansk-poland","krakow-poland","warsaw-poland","madrid-spain","barcelona-spain","cardiff-united-kingdom","london-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Clemizole HCl for Dravet Syndrome","inPlainEnglish":"This is a multicenter, Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study designed to measure the how well it works and safety of clemizole hydrochloride (EPX-100) as added on top of your current treatment therapy in children and adult participants with Dravet syndrome (DS).","whoItsFor":["Ages 2 Years to any","Male and female participants 2 years and older at time of consent","Clinical diagnosis of DS. Participants must have seizures which are not completely controlled by AEDs with the following criteria:","Onset of seizures prior to 18 months of age,","Normal development at onset,","History of at least one type of countable motor seizure (CMS),","Brain MRI without cortical malformation (not including mild atrophy associated with the natural progression of DS),","Genetic mutation of the SCN1A gene must be documented"],"whoShouldSkip":["Known sensitivity, allergy, or previous exposure to clemizole HCl","Exposure to any investigational drug or device \\<90 days prior to Screening or plans to participate in another drug or device trial at any time during the study","Concurrent use of lorcaserin. Note: Prior use of lorcaserin is permitted if at least 30 days have passed since the last dose","Concurrent use of fenfluramine","Epilepsy surgery planned during the study or epilepsy surgery within 6 months prior to Screening"],"whatHappens":"If you join, the listed intervention(s) are Clemizole HCl, or Placebo. The registry lists allocation as randomized. This is a multicenter, Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study designed to measure the how well it works and safety of clemizole hydrochloride (EPX-100) as added on top of your current treatment therapy in children and adult participants with Dravet syndrome (DS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 150 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.911Z"},{"nctId":"NCT04472767","title":"Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma","officialTitle":"Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, Irvine","sponsorClass":"OTHER","summary":"This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.","conditions":["Hepatocellular Carcinoma","HCC"],"keywords":["Hepatocellular Carcinoma","HCC","Cabozantinib","Ipilimumab","Nivolumab","TACE","transarterial chemoembolization"],"interventions":[{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Ipilimumab"},{"type":"DRUG","name":"Cabozantinib"},{"type":"PROCEDURE","name":"Transarterial Chemoembolization"}],"enrollment":35,"startDate":"2020-08-07","completionDate":"2027-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologic or radiographic diagnosis of hepatocellular carcinoma\n* At least one lesion amenable to TACE treatment\n* Child-Pugh A-B7 (B7 based on Albumin allowed)\n* Not a candidate for resection or transplantation\n* Age ≥ 18 years.\n* Performance status: ECOG performance status ≤2\n* Must have at least one measurable lesion (either untreated or progressed after previous locoregional treatment)\n* Adequate organ and marrow function as defined below:\n\n  1. Leukocytes ≥ 2,000/mcL\n  2. absolute neutrophil count ≥ 1000/mcL\n  3. platelets ≥ 60,000/mcl\n  4. total bilirubin within normal institutional limits\n  5. AST(SGOT)/ALT(SPGT) ≤ 3 X institutional upper limit of normal or ≤ 5 X if liver metastases are present\n  6. creatinine \\<1.5ULN\n  7. hemoglobin ≥ 8 g/dL\n  8. Serum albumin ≥ 2.8 g/dL\n  9. Urine protein/creatinine ration (UPCR) ≤ 1 mg/mg\n* The effects of cabozantinib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nBased on its mechanism of action, ipilimumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with ipilimumab and for 3 months following the last dose of ipilimumab.\n\nBased on its mechanism of action, nivolumab can cause fetal harm when administered to a pregnant woman. Females of reproductive potential must use effective contraception during treatment with nivolumab and for 5 months following the last dose of nivolumab.\n\n1\\. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n1. Has not undergone a hysterectomy or bilateral oophorectomy; or\n2. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\n   * Life expectancy of greater than 3 months\n   * Ability to swallow tablets\n   * Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Any type of previous systemic anti-cancer treatment\n* All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline\n* Any locoregional treatment for HCC within 3 months\n* Vp4 or Vp3 portal vein thrombus\n* Extrahepatic disease\n* Patients may not be receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, cabozantinib or other agents used in study.\n* Concomitant anticoagulation with coumarin agents (eg, warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitors (e.g., rivaroxaban), or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following:\n\n  1. Prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose low molecular weight heparins (LMWH).\n  2. Therapeutic doses of LMWH in subjects with a screening platelet count \\> 100,000/μL, without known brain metastases, and who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.\n* The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) test ≥ 1.3 x the laboratory ULN within 28 days before the first dose of study treatment.\n* Uncontrolled intercurrent illness including, but not limited to, the following conditions:\n\n  1. ongoing or active infection\n  2. symptomatic congestive heart failure\n  3. uncontrolled hypertension defined as sustained blood pressure (BP) \\> 150 mm Hg systolic or \\> 100 mm Hg diastolic despite optimal antihypertensive treatment\n  4. Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose\n  5. unstable angina pectoris\n  6. cardiac arrhythmia\n  7. evidence of tumor invading GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction.\n  8. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.\n\n     Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose.\n  9. Clinically significant hematuria, hematemesis, or hemoptysis of \\> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose.\n  10. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation.\n  11. Lesions invading any major blood vessels. Subjects with lesions invading the intrahepatic vasculature, including portal vein, hepatic vein, and hepatic artery, are eligible.\n  12. Other clinically significant disorders that would preclude safe study participation:\n\n      1. Serious non-healing wound/ulcer/bone fracture\n      2. Uncompensated/symptomatic hypothyroidism\n      3. Moderate to severe hepatic impairment (Child-Pugh B or C)\n  13. psychiatric illness/social situations that would limit compliance with study requirements.\n* Major surgery (e.g., laparoscopic nephrectomy, GI surgery, removal or biopsy of brain metastasis) within 2 weeks before first dose of study treatment. Minor surgeries within 10 days before first dose. Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.\n* Prior treatment with cabozantinib\n* Corrected QT interval calculated by the Fridericia formula (QTcF) \\> 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment.\n\nCorrected QT (QTc) = QT / ∛RR\n\nQT: duration of QT interval RR: duration of RR interval\n\nNote: If a single ECG shows a QTcF with an absolute value \\> 500 ms, two additional ECGs at intervals of approximately 3 min must be performed within 30 min after the initial ECG, and the average of these three consecutive results for QTcF will be used to determine eligibility.\n\n* Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before first dose of study treatment.\n* History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ and not treated with systemic therapy.\n* Inability to comply with study and follow-up procedures as judged by the Investigator\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants\n* Has fibrolamellar HCC\n* Has received prior cytotoxic, biologic or other systemic anticancer therapy including investigational agents within 4 weeks prior to randomization.\n* Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.\n* Has received a live vaccine within 30 days prior to the first dose of study intervention. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* Has severe hypersensitivity (Grade ≥ 3) to nivolumab or cabozantinib and/or any of their excipients.\n* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n* Has a history or current evidence of any condition (eg, known deficiency of the enzyme dihydropyrimidine dehydrogenase), therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.","locations":[{"facility":"Chao Family Comprehensive Cancer Center, University of California, Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chao Family Comprehensive Cancer Center University of California, Irvine","phone":"1-877-827-7883","email":"ucstudy@uci.edu"},{"name":"University of California Irvine Medical","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants with Progression-free Survival at 6 Months","Complete Response Rate"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["orange-california"],"enrichment":{"headline":"Phase 2: testing Nivolumab for Hepatocellular Carcinoma","inPlainEnglish":"This is a phase 2 single-arm, open-label clinical trial determining how well it works of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.","whoItsFor":["Ages 18 Years to any","Histologic or radiographic diagnosis of hepatocellular carcinoma","At least one lesion amenable to TACE treatment","Child-Pugh A-B7 (B7 based on Albumin allowed)","Not a candidate for resection or transplantation","Performance status: how well you can do daily activities (ECOG score) ≤2","Must have at least one measurable lesion (either untreated or progressed after previous locoregional treatment)","Adequate organ and marrow function as defined below:"],"whoShouldSkip":["Any type of previous systemic anti-cancer treatment","All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline","Any locoregional treatment for HCC within 3 months","Vp4 or Vp3 portal vein thrombus","Extrahepatic disease","Patients may not be receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, cabozantinib or other agents used in study"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab, Ipilimumab, or Cabozantinib. The registry lists allocation as na. This is a phase 2 single-arm, open-label clinical trial determining how well it works of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at Orange. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.636Z"},{"nctId":"NCT04486833","title":"Quaratusugene Ozeplasmid (Reqorsa) and Osimertinib in Patients With Advanced Lung Cancer Who Progressed on Osimertinib","officialTitle":"A Phase 1/2 Open-Label, Dose-Escalation and Clinical Response Study of Quaratusugene Ozeplasmid in Combination With Osimertinib in Patients With Advanced, Metastatic EGFR-Mutant, Metastatic Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Genprex, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this randomized study is to determine the safety and efficacy of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.\n\nThe study is comprised of a Phase 1 dose escalation portion and two Phase 2 portions evaluating safety and efficacy. Enrollment in the Phase 1 dose escalation portion is complete and the recommended Phase 2 dose (RP2D) was determined. Phase 2a has initiated and enrolled patients are treated with quaratusugene ozeplasmid at the RP2D in combination with osimertinib. In Phase 2b, patients will be randomized to receive either quaratusugene ozeplasmid plus osimertinib or platinum-based chemotherapy.","conditions":["Carcinoma, Non-Small Cell Lung"],"keywords":["Epidermal growth factor receptor mutation (EGFR)","osimertinib","Tumor suppressor gene 2 (TUSC2)","Lipid nanoparticle (LNP)","Gene therapy","Tagrisso","FUS1-nanoparticles","NSCLC","Reqorsa","quaratusugene ozeplasmid"],"interventions":[{"type":"BIOLOGICAL","name":"quaratusugene ozeplasmid"},{"type":"DRUG","name":"osimertinib"},{"type":"DRUG","name":"Platinum-Based Chemotherapy"}],"enrollment":158,"startDate":"2021-09-03","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically or cytologically documented NSCLC.\n3. Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery.\n4. The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluation of circulating tumor DNA.\n5. Achieved clinical response to osimertinib for ≥4 months, which can be a response of stable disease. Must have a minimum of a 10-day osimertinib washout completed at the time of enrollment.\n6. Must have radiological progression on osimertinib treatment and can have either asymptomatic disease or symptomatic disease. In addition:\n\n   1. Must have measurable disease per RECIST 1.1.\n   2. Must have progression on osimertinib treatment as a single agent or in combination with other anti-cancer agents as their most recent treatment.\n\n   Notes:\n   * Patients may have had treatment with other EGFR inhibitors as single agents prior to osimertinib.\n   * Patients may have progression on osimertinib treatment being used for adjuvant therapy after surgery.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) score from 0 to 1.\n8. Must be ≥28 days beyond major surgical procedures such as thoracotomy, laparotomy, or joint replacement and must not have evidence of wound dehiscence, active wound infection, or comparable major residual complications of the surgery per Investigator assessment.\n9. Asymptomatic brain metastases must meet ALL criteria of the following (a-d):\n\n   1. No history of seizures in the preceding six months.\n   2. Definitive treatment must be completed ≥21 days.\n   3. Must be off steroids administered because of brain metastases or related symptoms for ≥7 days.\n   4. Post-treatment imaging must demonstrate stability or regression of the brain metastases.\n10. Must have and be willing to submit a prior tumor biopsy or undergo a biopsy during Screening to obtain tumor tissue for submission to a central laboratory for IHC analysis and FISH or qPCR testing.\n11. Absolute neutrophil count (ANC) \\>1500/mm3, platelet count \\>100,000/mm3 within ≤28 days.\n12. Adequate renal function documented by serum creatinine of ≤1.5 mg/dL or calculated creatinine clearance \\>50 ml/min within ≤28 days.\n13. Adequate hepatic function as documented by serum bilirubin \\<1.5 mg/dL and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 X upper limit of normal (ULN) within ≤28 days.\n14. Stable cardiac condition with a left ventricular ejection fraction ≥40% within ≤28 days.\n15. If female of childbearing potential (FOCBP), must have negative serum pregnancy test (serum beta-human chorionic gonadotropin \\[β-hCG\\]) within ≤7 days.\n16. FOCBP and non-sterile male patients with female partner(s) of childbearing potential must agree to use two forms of contraception including one highly effective and one effective method beginning ≥2 weeks prior to enrollment through four months following the last dose of study treatment.\n17. If male, must agree to no sperm donation during study treatment and for an additional four months following the last dose of study treatment.\n18. Must have voluntarily signed an informed consent in accordance with institutional policies.\n\nExclusion Criteria:\n\n1. Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator.\n2. Received prior gene therapy.\n3. Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies.\n4. Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days.\n5. Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic therapy.\n6. Active systemic viral, bacterial, or fungal infection(s) requiring treatment.\n7. Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol.\n8. History of myocardial infarction or unstable angina within ≤6 months.\n9. Known human immunodeficiency virus (HIV) infection or has active hepatitis infection.\n10. Female who is pregnant or breastfeeding.","locations":[{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Oncology Hematology","city":"Rockville","state":"Maryland","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"The Valley Hospital - Luckow Pavilion","city":"Paramus","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabrail Cancer Center Research","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Millennium Oncology","city":"Houston","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sr Director, Clinical Operations","phone":"1-877-774-GNPX","email":"kcombs@genprex.com"},{"name":"Chief Medical Officer","phone":"1-877-774-GNPX","email":"mberger@genprex.com"}],"primaryOutcomes":["Recommended Phase 2 Dose (RP2D) - Phase 1","Overall Response Rate (ORR) - Phase 2a","Progression-free Survival (PFS) - Phase 2b"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["los-angeles-california","lone-tree-colorado","urbana-illinois","lexington-kentucky","rockville-maryland","paramus-new-jersey","canton-ohio","houston-texas","fairfax-virginia","norfolk-virginia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing quaratusugene ozeplasmid for Carcinoma, Non-Small Cell Lung","inPlainEnglish":"The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically documented NSCLC","Stage III or IV NSCLC or recurrent NSCLC that is not potentially curable by radiotherapy or surgery","The NSCLC must be epidermal growth factor receptor (EGFR) mutation positive-positive based on results from most recent tissue biopsy or most recent evaluation of circulating tumor DNA","Achieved clinical response to osimertinib for ≥4 months, which can be a response of stable disease. Must have a minimum of a 10-day osimertinib washout completed at the time of enrollment","Must have radiological progression on osimertinib treatment and can have either asymptomatic disease or symptomatic disease. In addition:","Must have measurable disease per RECIST 1.1","Must have progression on osimertinib treatment as a single agent or in combination with other anti-cancer agents as their most recent treatment"],"whoShouldSkip":["Unable to tolerate osimertinib treatment, leading to early treatment discontinuation or prolonged/frequent dosage modifications as determined by the Investigator","Received prior gene therapy","Other genetic characteristics (such as ALK, ROS, BRAF V600E mutations) which make them a candidate for treatment with other approved targeted therapies","Received radiotherapy to the skull, spine, thorax, or pelvis within ≤30 days","Active concurrent malignancies, i.e., cancers other than NSCLC that require systemic therapy","Active systemic viral, bacterial, or fungal infection(s) requiring treatment","Serious concurrent illness or psychological, familial, sociological, geographical, or other concomitant conditions that, in the opinion of the Investigator, would not permit adequate follow-up and compliance with the study protocol"],"whatHappens":"If you join, the listed intervention(s) are quaratusugene ozeplasmid, osimertinib, or Platinum-Based Chemotherapy. The registry lists allocation as randomized. The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 158 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.687Z"},{"nctId":"NCT04516057","title":"Nabilone for Agitation Blinded Intervention Trial","officialTitle":"Nabilone for Agitation Blinded Intervention Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sunnybrook Health Sciences Centre","sponsorClass":"OTHER","summary":"This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority.\n\nNabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting.\n\nThe PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice.\n\nParticipants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.","conditions":["Alzheimer Disease","Agitation"],"keywords":["Cannabis","Cannabinoid","THC"],"interventions":[{"type":"DRUG","name":"Nabilone"},{"type":"OTHER","name":"Placebo"}],"enrollment":112,"startDate":"2021-02-01","completionDate":"2027-12","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Males or females ≥55 years of age; females must be post-menopausal\n2. Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included\n3. sMMSE ≤24\n4. Presence of clinically significant agitation based on the IPA definition\n5. If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization\n6. Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement.\n\nExclusion Criteria:\n\n1. Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)\n2. Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions\n3. Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment\n4. Current significant liver disease, as per investigator assessment\n5. Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)\n6. Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)\n7. Previous or current abuse of/dependence on marijuana\n8. Clinically significant delusions and/or hallucinations (NPI-NH delusion/hallucinations subscore ≥4)\n9. Reported recreational use of marijuana or other cannabis products within 3 months prior to study randomization","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Geras Centre for Aging Research, Hamilton Health Sciences","city":"Hamilton","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Ottawa Institute of Mental Health Research at The Royal","city":"Ottawa","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Michael's Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"TERMINATED","lat":null,"lon":null},{"facility":"Ontario Shores Centre for Mental Health Sciences","city":"Whitby","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NAB-IT Coordinating Centre","phone":"416-480-6100","email":"NAB-IT@sunnybrook.ca"}],"primaryOutcomes":["Agitation - Cohen-Mansfield Agitation Inventory (CMAI)"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["calgary-canada","hamilton-canada","london-canada","ottawa-canada","toronto-canada","whitby-canada"],"enrichment":{"headline":"Phase 3: testing Nabilone for Alzheimer Disease","inPlainEnglish":"This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms.","whoItsFor":["Ages 55 Years to any","Males or females ≥55 years of age; females must be post-menopausal","Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to AD. Patients with Major Neurocognitive Disorder due to multiple etiologies (AD and vascular) will be included","Presence of clinically significant agitation based on the IPA definition","If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization","Availability of a primary caregiver to accompany the participant to study visits and to participate in the study. The primary caregiver must be sufficiently proficient in English to complete the required study assessments, as per investigator judgement"],"whoShouldSkip":["Change in psychotropic medications less than 1 week prior to study randomization (e.g., concomitant antidepressants)","Contraindications to cannabinoids, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions","Current uncontrolled cardiovascular disease (e.g. uncontrolled hypertension, ischemic heart disease, arrhythmia and severe heart failure), as per investigator assessment","Current significant liver disease, as per investigator assessment","Presence or history of other psychiatric disorders or neurological conditions (e.g. psychotic disorders, schizophrenia, stroke, epilepsy)","Participants currently meeting DSM 5 criteria for Major Depressive Episode (MDE)","Previous or current abuse of/dependence on marijuana"],"whatHappens":"If you join, the listed intervention(s) are Nabilone, or Placebo. The registry lists allocation as randomized. This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 112 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.326Z"},{"nctId":"NCT04516447","title":"A Study of Azenosertib (ZN-c3) in Patients With Ovarian Cancer","officialTitle":"A Phase 1b Study of ZN-c3 in Combination With Chemotherapy or Bevacizumab in Subjects With Ovarian, Peritoneal, or Fallopian Tube Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc","sponsorClass":"INDUSTRY","summary":"This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.","conditions":["Solid Tumor","Epithelial Ovarian Cancer","Fallopian Tube Cancer","Peritoneal Cancer"],"keywords":["Solid Tumor"],"interventions":[{"type":"DRUG","name":"Azenosertib"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pegylated liposomal doxorubicin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Gemcitabine"},{"type":"BIOLOGICAL","name":"Bevacizumab"}],"enrollment":172,"startDate":"2020-10-26","completionDate":"2028-06-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\nFor Part 1:\n\n* Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma.\n* Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin.\n* The disease must be platinum resistant (ie, the PFI must have been \\< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed.\n\nFor Part 2 Dose Escalation:\n\nPrior therapy:\n\n• Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy\n\nResponse to prior platinum therapy:\n\n1. In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy.\n2. In the 2L setting:\n\n   1. Progressive Disease \\>183 days after receiving the last dose of platinum chemotherapy in the 1L setting,\n   2. Complete Response, Partial Response, or Stable Disease to 2L platinum-based chemotherapy.\n\n      * Adequate hematologic, and organ function\n\nFor Part 2 Dose Expansion:\n\n* Subjects must have at least 4 cycles of platinum-based chemotherapy in 2L and have Complete Response, Partial Response, or Stable Disease\n* Subjects must have progressed while on a PARP inhibitor for 1L maintenance Additional protocol-defined inclusion criteria may apply\n\nEXCLUSION CRITERIA:\n\n* Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor.\n* Subjects with carcinosarcomas (even if there is a serous component)\n* A serious illness or medical condition(s)\n* Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy.\n\nAdditional protocol-defined exclusion criteria may apply","locations":[{"facility":"Site 0264","city":"Aurora","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Site 0104","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 0111","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 0173","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 0259","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 0191","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 0196","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 0103","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 2707","city":"South Brisbane","state":"Queensland","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2708","city":"Sunshine Coast","state":"Queensland","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2718","city":"Sunshine Coast","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 2709","city":"Adelaide","state":"South Australia","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2716","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 2706","city":"Melbourne","state":"Victoria","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2705","city":"Nedlands","state":"Western Australia","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1001","city":"Banja Luka","state":"","country":"Bosnia and Herzegovina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1002","city":"Sarajevo","state":"","country":"Bosnia and Herzegovina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1003","city":"Tuzla","state":"","country":"Bosnia and Herzegovina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1202","city":"Panagyurishte","state":"","country":"Bulgaria","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1201","city":"Sofia","state":"","country":"Bulgaria","status":"COMPLETED","lat":null,"lon":null},{"facility":"3613","city":"Besançon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3624","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"3601","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"3608","city":"Lyon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3614","city":"Nantes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3623","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3604","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3625","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"3611","city":"Strasbourg","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"3603","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 1401","city":"Tbilisi","state":"","country":"Georgia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 1902","city":"Belgrade","state":"","country":"Serbia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2901","city":"Busan","state":"","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2903","city":"Seoul","state":"","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Site 2904","city":"Seoul","state":"","country":"South Korea","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"K-Group, Beta, Inc., a subsidiary of Zentalis Pharmaceuticals","phone":"8582634333","email":"medicalaffairs@zentalis.com"}],"primaryOutcomes":["Part 1: To investigate the safety and tolerability of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine","Part 1: To identify the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of azenosertib in combination with PLD, carboplatin, paclitaxel, or gemcitabine","Part 2: To estimate the safety/tolerability of azenosertib in combination with bevacizumab","Part 2: To identify the recommended dose for Part 2 Dose Expansion"],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":[],"locationSlugs":["aurora-colorado","boston-massachusetts","st-louis-missouri","new-york-new-york","durham-north-carolina","providence-rhode-island","nashville-tennessee","houston-texas","south-brisbane-australia","sunshine-coast-australia","adelaide-australia","melbourne-australia","nedlands-australia","banja-luka-bosnia-and-herzegovina","sarajevo-bosnia-and-herzegovina","tuzla-bosnia-and-herzegovina","panagyurishte-bulgaria","sofia-bulgaria","besan-on-france","bordeaux-france","dijon-france","lyon-france","nantes-france","paris-france","rennes-france","strasbourg-france","toulouse-france","tbilisi-georgia","belgrade-serbia","busan-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing Azenosertib for Solid Tumor","inPlainEnglish":"This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.","whoItsFor":["Ages 18 Years to any","Women only","Histologically or cytologically confirmed FIGO Stage III/IV high-grade serous or endometrioid ovarian, fallopian tube, or peritoneal carcinoma","Subjects must have received 1 or 2 prior therapeutic regimens/lines of therapy in the advanced or metastatic setting. At least one regimen must have contained cisplatin or carboplatin","The disease must be platinum resistant (ie, the PFI must have been \\< 6 months). Platinum refractory disease (ie, PD during first-line platinum-based therapy) is allowed","For Part 2 Dose Escalation:","Subjects must have received 6 cycles of platinum-based doublet chemotherapy in the 1L or 2L setting as their most recent therapy","Response to prior platinum therapy:","In the 1L setting: Complete Response, Partial Response, or Stable Disease to platinum-based chemotherapy"],"whoShouldSkip":["Histology of abdominal adenocarcinoma of unknown origin or diagnosis of a borderline ovarian tumor","Subjects with carcinosarcomas (even if there is a serous component)","A serious illness or medical condition(s)","Subjects with active (uncontrolled, metastatic) second malignancies or requiring therapy","Additional protocol-defined"],"whatHappens":"If you join, the listed intervention(s) are Azenosertib, Carboplatin, or Pegylated liposomal doxorubicin. The registry lists allocation as randomized. This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 172 people at 35 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.159Z"},{"nctId":"NCT04557449","title":"Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors","officialTitle":"A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.\n\nPart 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.\n\nPart 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.\n\nThe Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.\n\nIn Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion.\n\nIn Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).\n\nIn Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from Part 1A will be conducted.\n\nIn Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI).\n\nIn Part 1F, escalating doses of PF-07220060 will be administered in combination with enzalutamide.\n\nIn Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.\n\nPart 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060.\n\nPart 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively.\n\nPart 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy.\n\nPart 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK.\n\nThe China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.","conditions":["Liposarcoma","Prostate Cancer","Advanced Breast Cancer","NSCLC (Non-small Cell Lung Cancer)","Colorectal Cancer"],"keywords":["CDK4 inhibitor","Breast cancer","enzalutamide","fulvestrant","letrozole","endocrine therapy","Colorectal Cancer (CRC)","Solid Tumors","giredestrant","tamoxifen"],"interventions":[{"type":"DRUG","name":"PF-07220060"},{"type":"COMBINATION_PRODUCT","name":"Letrozole"},{"type":"COMBINATION_PRODUCT","name":"Fulvestrant"},{"type":"OTHER","name":"Midazolam"},{"type":"COMBINATION_PRODUCT","name":"Enzalutamide"},{"type":"COMBINATION_PRODUCT","name":"Giredestrant"},{"type":"COMBINATION_PRODUCT","name":"Tamoxifen"}],"enrollment":430,"startDate":"2020-09-23","completionDate":"2029-10-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Part 1: Breast Cancer (BC)\n\n  * Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC\n  * Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC\n* Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests\n* Part 1F: prostate cancer\n* Part 1G: HR-positive/HER2-negative BC\n* Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC\n* Part 1D: metastatic castration resistant prostate cancer\n* Giredestrant Combination Cohort: ER-positive/HER2-negative BC\n* Prior systemic Treatment\n\n  * Part 1: HR-positive/HER2-negative BC\n\n    * At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator\n    * HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy\n    * Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available\n  * Part 2A and 2E: at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed\n  * Part 2B: no prior systemic anti-cancer therapies for advanced/metastatic BC\n  * Part 2C:\n\n    * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or\n    * Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal\n    * One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy\n  * Part 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy\n  * Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy\n\nGeneral Inclusion Criteria\n\n* All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1\n* Adequate renal, liver, and bone marrow function\n\nExclusion Criteria:\n\n* Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor\n* Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway\n* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease\n* Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ\n* Major surgery or radiation within 4 weeks prior to study intervention\n* Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4\n* Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry\n* Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis\n* Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate \\<50 bpm at screening\n* Pregnant or breastfeeding female participant\n* Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease","locations":[{"facility":"Ellison Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Yale New Haven Health","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale-New Haven Hospital-Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Phase 1 Unit","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham & Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute- Chestnut Hill","city":"Newton","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute - Pharmacy","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - West Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Británico de Buenos Aires","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fundación Cenit Para La Investigación En Neurociencias","city":"CABA","state":"Ciudad Autã³noma de Buenos Aires","country":"Argentina","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar","city":"Buenos Aires","state":"","country":"Argentina","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clínica Universitaria Reina Fabiola","city":"Córdoba","state":"","country":"Argentina","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fundación CORI para la Investigación y Prevención del Cáncer","city":"La Rioja","state":"","country":"Argentina","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cancer Hospital Chinese Academy of Medical Science","city":"Beijing","state":"Beijing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital","city":"Zhengzhou","state":"Henan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital","city":"Wuhan","state":"Hubei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi’an","state":"Shanxi","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Vseobecna fakultni nemocnice v Praze","city":"Prague","state":"","country":"Czechia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa","state":"Chiba","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"COI Centro Oncologico Internacional S.A.P.I. de C.V.","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital MAC Periferico Sur","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"INCAN","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario \"Dr. Jose Eleuterio Gonzalez\"","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Reforma","city":"Oaxaca City","state":"Oaxaca","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Oaxaca Site Management Organization","city":"Oaxaca City","state":"","country":"Mexico","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA","city":"Bratislava","state":"","country":"Slovakia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Narodny onkologicky ustav","city":"Bratislava","state":"","country":"Slovakia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fakultna nemocnica s poliklinikou Nove Zamky","city":"Nové Zámky","state":"","country":"Slovakia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cancer Research UK Edinburgh Centre","city":"Edinburgh","state":"Edinburgh, CITY of","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital","city":"London","state":"London, CITY of","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute UK","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of participants with dose limiting toxicities in the Dose Escalation or De-escalation Portion","Incidence of clinically significant AEs","Incidence of clinically significant laboratory assessments","Incidence of clinically significant abnormal vital and ECG parameters","Maximal Plasma Concentration (Cmax) of PF-07220060 given with and without food","Time to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without food","Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without food","Maximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060","Time to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060","Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060","Steady State Maximal Concentration (Cmax,ss) of PF-07220060","Steady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060","Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060","Steady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060","Steady State Maximal Concentration (Cmax,ss) of Giredestrant","Steady State Time to Maximum Plasma Concentration (Tmax,ss) of Giredestrant","Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of Giredestrant","Steady State Minimum Plasma Concentration (Cmin,ss) of Giredestrant"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","colorectal-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","new-haven-connecticut","trumbull-connecticut","boston-massachusetts","newton-massachusetts","grand-rapids-michigan","nashville-tennessee","houston-texas","ciudad-aut-noma-de-buenos-aires-argentina","caba-argentina","buenos-aires-argentina","c-rdoba-argentina","la-rioja-argentina","beijing-china","zhengzhou-china","wuhan-china","xian-china","hangzhou-china","prague-czechia","kashiwa-japan","mexico-city-mexico","monterrey-mexico","oaxaca-city-mexico","bratislava-slovakia","nov-z-mky-slovakia","edinburgh-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 2: testing PF-07220060 for Liposarcoma","inPlainEnglish":"This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort.","whoItsFor":["Ages 18 Years to any","Part 1: Breast Cancer (BC)","Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC","Part 1A/Part 1D/Part 1E also include: Refractory HR-positive/HER2-positive BC","Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests","Part 1F: prostate cancer","Part 1G: HR-positive/HER2-negative BC","Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC"],"whoShouldSkip":["Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor","Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway","Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease","Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ","Major surgery or radiation within 4 weeks prior to study intervention","Last anti-cancer treatment within 2 weeks prior to study intervention; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4","Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry"],"whatHappens":"If you join, the listed intervention(s) are PF-07220060, Letrozole, or Fulvestrant. The registry lists allocation as randomized. This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and in combination with endocrine therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 430 people at 39 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.954Z"},{"nctId":"NCT04557969","title":"Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","officialTitle":"Prospective Study of Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Objective:\n\nTo follow people with GISTs and collect tumor tissue so that it can be studied in the lab.\n\nEligibility:\n\nPeople age 6 and older who have a GIST.\n\nDesign:\n\nParticipants will be screened with a review of their medical records and samples.\n\nParticipants will enroll in 1 other NIH study, and may be asked to enroll in 2 other optional NIH studies.\n\nParticipants will have a medical history and physical exam. Data about how they function in their daily activities will be obtained.\n\nParticipants may speak with a genetic counselor. They may have genetic testing.\n\nParticipants will give blood samples. They may have a cheek swab. For this, small brush will be rubbed against the inside of the cheek.\n\nParticipants may have a computed tomography (CT) scan of the chest, abdomen, and pelvis. Or they may have a CT scan of the chest and magnetic resonance imaging (MRI) of the abdomen and pelvis.\n\nParticipants will be monitored every 6-12 months at the NIH Clinical Center, for up to 10 years before having surgery. If they need surgery, it will be performed at the NIH. Then, they will be monitored every 6-12 months, for up to 5 years after surgery.\n\nIf a participant has surgery, tumor tissue samples and research specimen will be taken.\n\nIf a participant does not need surgery, their participation will end after 10 years. If they have surgery, the 5-year monitoring period will restart after each surgery.","conditions":["Gastric Cancer","Gastric Neoplasm","Gastrointestinal Stromal Sarcoma","Gastrointestinal Stromal Neoplasm","Gastrointestinal Stromal Tumor (GIST)"],"keywords":["Tyrosine Kinase Inhibitor (TKI) Therapy","Wild-Type GISTs (WT GISTs)","PDGFRA Mutation","KIT Mutation","SDH Mutation","Natural History"],"interventions":[],"enrollment":400,"startDate":"2020-12-18","completionDate":"2040-12-30","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample.\n* Age \\>= 6 years\n* ECOG performance status \\<= 2 (Karnofsky or Lansky \\>= 60%)\n* Ability of participant or parent/guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n\\- Non-modifiable medical comorbidities that would preclude cytoreductive surgery.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephanie N Canady, R.N.","phone":"(240) 858-7573","email":"stephanie.canady@nih.gov"},{"name":"Andrew M Blakely, M.D.","phone":"(240) 760-7647","email":"andrew.blakely@nih.gov"}],"primaryOutcomes":["Evaluate and follow patients with GISTs, particularly WT or treatment-refractory non-WT, to support translational research for this rare disease","Assess disease-free intervals (DFIs) between surgical resection of disease for at least 5 years"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Surgery in Gastrointestinal Stromal Tumors (GISTs) for Treatment, Tumor Modeling, and Genomic Analysis","inPlainEnglish":"Objective: To follow people with GISTs and collect tumor tissue so that it can be studied in the lab. Eligibility: People age 6 and older who have a GIST.","whoItsFor":["Ages 6 Years to any","Histological confirmation or clinical presentation suspicious of GIST; histological confirmation will be preferably by review of archival tissue if available, fresh biopsy will not be required if inadequate tissue sample","how well you can do daily activities (ECOG score) \\<= 2 (Karnofsky or Lansky \\>= 60%)"],"whoShouldSkip":["\\- Non-modifiable medical comorbidities that would preclude cytoreductive surgery"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.968Z"},{"nctId":"NCT04567771","title":"Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer","officialTitle":"A Comparison of Acute Toxicities Between Patients Treated With Protons or Intensity-Modulated Radiation Therapy for Post-Operative Treatment of Endometrial or Cervical Cancers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors. Using quality of life questionnaires and adverse event assessments may help doctors learn whether proton radiation therapy is associated with lower acute gastrointestinal toxicities at the end of treatment compared to intensity modulated radiation therapy in patients with endometrial or cervical cancer.","conditions":["Cervical Carcinoma","Endometrial Carcinoma","Endometriosis","Pelvic Inflammatory Disease"],"keywords":[],"interventions":[{"type":"OTHER","name":"Quality-of-Life Assessment"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"RADIATION","name":"Radiation Therapy"}],"enrollment":121,"startDate":"2020-12-04","completionDate":"2029-04-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed diagnosis of cervical or endometrial cancer\n* Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium\n* History and physical prior to registration\n* Documentation of history of:\n\n  * Smoking status\n  * Pelvic infection\n  * Pelvic inflammatory disease\n  * Endometriosis\n* Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site\n* Plan for RT to pelvis with or without para-aortic lymph node irradiation\n* If received high-dose chemotherapy prior to registration, last dose must have been given \\>= 21 days prior to start of RT\n* Complete blood count (CBC) performed within 21 days prior to registration\n* Computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET)/CT, or PET/MRI for staging before registration; may be pre-operative (op) or post-op\n* Eastern Cooperative Oncology Group (ECOG) performance score 0-2\n* Provide written informed consent\n* Willing to complete quality of life (QOL) questionnaires\n\nExclusion Criteria:\n\n* Receiving external beam boost dose during RT\n* Distant metastases\n* Gross disease at time of RT\n* Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas\n* Patients who exceed the weight/size limits of the treatment table\n* Positive or close surgical margins (=\\< 3 mm)\n* Prior RT to the pelvis\n* Planned to receive inguinal node RT\n* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects\n* Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note that human immunodeficiency virus (HIV) testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be immunosuppressive.\n* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months\n  * Transmural myocardial infarction within the last 6 months\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration\n* Other major medical illness which requires hospitalization or precludes study therapy at the time of registration\n* Patients unwilling to have rectal balloon placed on a daily basis during RT","locations":[{"facility":"Mayo Clinic in Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Change in Expanded Prostate Cancer Index Composite (EPIC) Bowel score"],"hasResults":false,"conditionSlugs":["cervical-cancer","endometriosis"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","jacksonville-florida","rochester-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: Quality-of-Life Assessment for Cervical Carcinoma","inPlainEnglish":"This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer. Radiation therapy uses high energy protons or x-rays to kill tumor cells and shrink tumors.","whoItsFor":["Ages 18 Years to any","Women only","Histologically confirmed diagnosis of cervical or endometrial cancer","Must have undergone an open or robotic hysterectomy (total abdominal, vaginal, radical, or total laparoscopic) for carcinoma of the cervix or endometrium","History and physical prior to registration","Documentation of history of:","Pelvic inflammatory disease","Planned to receive either proton or IMRT radiation treatment, with use of rectal balloon, at any Mayo Clinic site","Plan for RT to pelvis with or without para-aortic lymph node irradiation"],"whoShouldSkip":["Receiving external beam boost dose during RT","Gross disease at time of RT","Histology of endometrial stromal sarcoma, leiomyosarcoma, melanoma or small cell carcinomas","Patients who exceed the weight/size limits of the treatment table","Positive or close surgical margins (=\\< 3 mm)","Prior RT to the pelvis","Planned to receive inguinal node RT"],"whatHappens":"If you join, the listed intervention(s) are Quality-of-Life Assessment, Questionnaire Administration, or Radiation Therapy. The registry lists allocation as na. This early phase I trial compares the side effects between patients treated with proton radiation therapy versus intensity modulated radiation therapy after surgery for the treatment of endometrial or cervical cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 121 people at 3 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.117Z"},{"nctId":"NCT04571658","title":"NEPTUNE Match Study","officialTitle":"Implementing Precision Medicine for Glomerular Diseases in the Nephrotic Syndrome Study Network (NEPTUNE)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.","conditions":["Nephrotic Syndrome in Children","Focal Segmental Glomerulosclerosis","Minimal Change Disease","Minimal Change Nephrotic Syndrome","Membranous Nephropathy","FSGS","MCD","MCD - Minimal Change Disease","Alport Syndrome"],"keywords":["Nephrotic Syndrome","NEPTUNE","Match","Clinical Trial Match"],"interventions":[{"type":"OTHER","name":"Communication"}],"enrollment":375,"startDate":"2022-05-02","completionDate":"2029-12-30","sex":"ALL","minAge":"1 Year","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE observational study\n2. Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible).\n\n   Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended.\n3. Regular nephrology healthcare provided at a NEPTUNE study site.\n4. Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match\n\nExclusion Criteria:\n\nCurrently non-NEPTUNE observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments.\n\nExclusion Criteria:\n\n1\\. Non-English or non-Spanish speaking","locations":[{"facility":"Emory University Hospital - Children's Hospital of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John H. Stroger, Jr., Hospital of Cook County","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"ENROLLING_BY_INVITATION","lat":null,"lon":null},{"facility":"Children's Mercy Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell/Cohen's Children's Hospital","city":"New Hyde Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of the University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charlotte","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Sacred Heart Medical Center","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hailey E Desmond, MS","phone":"734-232-4851","email":"heturner@med.umich.edu"},{"name":"Chrysta C Lienczewski, BS","phone":"734-615-5021","email":"boridley@med.umich.edu"}],"primaryOutcomes":["Matched participants with at least one clinical trial receive a MNB assessment","Efficacy of communication methods at time of communication visit, measured by Teach Back 1 summary score","Kidney health endpoints that are specific to each individual trial"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["atlanta-georgia","chicago-illinois","kansas-city-kansas","baltimore-maryland","ann-arbor-michigan","kansas-city-missouri","new-hyde-park-new-york","new-york-new-york","chapel-hill-north-carolina","cleveland-ohio","philadelphia-pennsylvania","charlotte-south-carolina","seattle-washington","spokane-washington"],"enrichment":{"headline":"Not a traditional drug phase: Communication for Nephrotic Syndrome in Children","inPlainEnglish":"NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.","whoItsFor":["Ages 1 Year to 80 Years","Consented and eligible participants in the biopsied or non-biopsied cohorts of the NEPTUNE watch-and-measure (no experimental treatment required) study","Must be potentially eligible for the NEPTUNE Match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible)","Note: NEPTUNE Match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended","Regular nephrology healthcare provided at a NEPTUNE study site","Willing and able to consent, and as appropriate assent, to participate in NEPTUNE Match"],"whoShouldSkip":["Currently non-NEPTUNE watch-and-measure (no experimental treatment required) study participants are not eligible to be matched to a clinical trial using these biomarker assessments"],"whatHappens":"If you join, the listed intervention(s) are Communication. The registry lists allocation as na. NEPTUNE Match is an additional opportunity offered to NEPTUNE study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 375 people at 16 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.768Z"},{"nctId":"NCT04573140","title":"A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)","officialTitle":"A Phase I/II Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM), and Recurrent/Progressive Medulloblastoma (MB)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Florida","sponsorClass":"OTHER","summary":"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG). Funding Source - FDA OOPD","conditions":["Adult Glioblastoma","High Grade Glioma","WHO Grade III or IV Malignant Glioma"],"keywords":["Immunotherapy","Brain Tumor","Adult","newly diagnosed","clinical trial","Pediatric brain tumor"],"interventions":[{"type":"BIOLOGICAL","name":"Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs)"}],"enrollment":28,"startDate":"2021-12-13","completionDate":"2027-07-01","sex":"ALL","minAge":"4 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Stratum 1 (Adult GBM)\n\n* Age ≥ 21 years.\n* Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated.\n* The tumor must have a supratentorial component.\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest perpendicular diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  * ANC (Absolute neutrophil count) ≥ 1,000µl (unsupported)\n  * Platelets ≥ 150/µl (unsupported for at least 7 days)\n  * Hemoglobin \\> 8 g/dL\n* Renal:\n\n  * BUN ≤ 25 mg/dl\n  * Creatinine ≤ 1.7 mg/dl\n* Hepatic\n\n  * Bilirubin ≤ 2.0 mg/dl\n  * ALT ≤ 5 times institutional upper limits of normal for age\n  * AST ≤ 5 times institutional upper limits of normal for age\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations\n* Signed informed consent. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the legally authorized representative.\n* For women of childbearing potential (WOCBP), negative serum/urine pregnancy test at enrollment (test will be repeated within 72 hours prior to starting TMZ in Stratum 1 patients).\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males with female partners of childbearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n\nStratum 2 (Newly-diagnosed Pediatric HGG)\n\n* Age \\> 3 and ≤ 25 years.\n* Histologically confirmed WHO Grade III or IV malignant glioma\n* Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs).\n* Residual post-surgical disease burden ≤ 3 cm as defined by longest diameter of tumor on post-operative MRI.\n* Patients must have recovered from the effects of surgery, postoperative infection, and other complications.\n* A diagnostic contrast-enhanced MRI of the brain must be performed preoperatively and postoperatively. Pre-op MRI must be performed within 28 days prior to study enrollment. Post-op MRI must be completed within 7 days after surgery. Preoperative and postoperative scans must be the same type.\n* Performance Score: Karnofsky ≥ 60 for participants \\> 16 years of age and Lansky ≥ 60 for participants \\< 16 years of age assessed within 2 weeks prior to enrollment. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n* Bone Marrow:\n\n  1. ANC (Absolute neutrophil count) ≥ 1,000/µl (unsupported)\n  2. Platelets ≥ 100/µl (unsupported for at least 7 days)\n  3. Hemoglobin \\> 8 g/dL (may be supported)\n* Renal: Creatinine clearance or radioisotope GFR ≥ 70mL/min/1.73 m2 or acceptable serum creatinine based on age/gender\n* Hepatic:\n\n  1. Bilirubin ≤ 3 times upper limit of institutional normal for age.\n  2. SGPT (ALT) ≤ 5 times upper limit of institutional normal for age.\n  3. SGOT (AST) ≤ 5 times upper limit of institutional normal for age.\n* Participants who are receiving systemically-administered steroids must be on a stable or decreasing dose for \\>1 week prior to enrollment. The patient steroid dose should be no more than a dexamethasone-equivalent of 2.8 mg/m2/day. Corticosteroid physiologic replacement therapy for management of pituitary/adrenal axis insufficiency and/or topical administration (e.g. inhaled or dermatologic) is allowed.\n* Willing to take an antiepileptic medication such as levetiracetam for the duration of RNA-LP vaccinations.\n* A legal parent/guardian or patient must be able to understand and be willing to sign a written informed consent and assent document, as appropriate.\n* For women of childbearing potential (WOCBP), negative serum/urine pregnancy test at enrollment\n* WOCBP must be willing to use acceptable contraceptive methods to avoid pregnancy throughout the study and for at least 24 weeks after the last dose of study drug. Refer to Appendix F for definition of WOCBP and guidance on acceptable contraceptive methods.\n* Males of child-fathering potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 24 weeks following the last dose of study drug.\n* Participants with post-surgical neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must be enrolled on PNOC COMP prior to enrollment on PNOC020 if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\nStratum 1 (Adult GBM)\n\n* Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)\n* MGMT Methylated tumors\n* Gliomatosis Cerebri\n* Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement.\n* Recurrent or multifocal malignant gliomas.\n* Metastatic or leptomeningeal disease\n* Residual post-surgical disease burden \\> 3 cm as defined by longest perpendicular diameter on MRI.\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Known active infection or immunosuppressive disease.\n* Participants who require corticosteroids above physiologic doses or not weaned to physiologic dosing within 1 week of scheduled vaccination.\n* Prior chemotherapy or radiosensitizers (including Gliadel wafers) for cancers of the head and neck region, other than TMZ prescribed during radiation for GBM (prior chemotherapy for a different cancer is allowable).\n* Prior radiotherapy to the head or neck, resulting in overlap of radiation fields. Radiosurgery is not permitted.\n* Severe, active co-morbidity, defined as follows:\n\n  * Unstable angina and/or congestive heart failure requiring hospitalization.\n  * Unstable cardiac arrhythmias, abnormalities, or transmural myocardial infarction within the last 6 months.\n  * Acute bacterial or fungal infection requiring intravenous antibiotics at initiation of XRT/TMZ.\n  * Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at initiation of XRT/TMZ.\n  * Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.\n  * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.\n  * Patients with autoimmune disease requiring medical management with immunosuppressants.\n  * Major medical illnesses or psychiatric impairments that, in the investigator's opinion, will prevent administration or completion of protocol therapy.\n  * Active connective tissue disorders such as lupus or scleroderma that, in the investigator's opinion, place the patient at high risk for radiation toxicity.\n  * Pregnancy or women of childbearing potential and men who are sexually active and who are unwilling or unable to use an acceptable method of contraception for the entire study period; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.\n* Women of childbearing potential must not be pregnant or breast-feeding.\n* Prior history of brachial neuritis or Guillain-Barré syndrome.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations\n\nStratum 2 (Pediatric HGG)\n\n* Diffuse intrinsic pontine glioma, brainstem diffuse midline glioma, or BRAFV600E+\n* Bulky disease, defined as:\n\n  * Tumor with evidence of clinically significant uncal herniation, midline shift, tonsillar herniation, or brainstem infiltration, or that shows significant mass effect in either brain or spine\n  * Tumor with extensive and diffuse multilobular involvement (\\>3 lobes)\n  * Tumor with extracranial disease\n* Known HIV, Hepatitis B, or Hepatitis C seropositive.\n* Uncontrolled seizure disorder\n* History of myocarditis\n* Receipt of any live vaccine within 30 days prior to enrollment\n* Known active infection or immunosuppressive disease.\n* Participants with significant renal, cardiac (congestive cardiac failure, myocardial infarction, myocarditis), pulmonary, hepatic or other organ dysfunction.\n* Severe or unstable concurrent medical conditions.\n* Women must not be pregnant or breast-feeding.\n* Participants who are receiving any other investigational agents or who have been treated on any other therapeutic clinical protocols within 30 days prior to study entry.\n* Participants who are unwilling or unable to receive treatment and undergo follow-up evaluations.","locations":[{"facility":"Children's National Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marcia Hodik","phone":"352-273-5519","email":"wells-BTC@ufl.edu"}],"primaryOutcomes":["Manufacturing feasibility","Safety of RNA-LP vaccine","Determination of Maximum Tolerated Dose"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","gainesville-florida"],"enrichment":{"headline":"Phase 1: testing Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs) for Adult Glioblastoma","inPlainEnglish":"The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG).","whoItsFor":["Ages 4 Years to any","Stratum 1 (Adult GBM)","Histopathologically proven newly-diagnosed de novo GBM (WHO Grade IV glioma, secondary GBM not eligible) that is MGMT low level or unmethylated","The tumor must have a supratentorial component","Patient must have been enrolled on a screening consent and have had sterile collection of tumor material in a manner suitable for RNA extraction, amplification, and loading of lipid particles (LPs)","Residual post-surgical disease burden ≤ 3 cm as defined by longest perpendicular diameter of tumor on post-operative MRI","Patients must have recovered from the effects of surgery, postoperative infection, and other complications","Performance Score: (KPS) ≥ 60. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score"],"whoShouldSkip":["Stratum 1 (Adult GBM)","Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible.)","MGMT Methylated tumors","Gliomatosis Cerebri","Metastases detected below the tentorium or beyond the cranial vault and leptomeningeal involvement","Recurrent or multifocal malignant gliomas","Metastatic or leptomeningeal disease"],"whatHappens":"If you join, the listed intervention(s) are Autologous total tumor mRNA and pp65 full length (fl) lysosomal associated membrane protein (LAMP) mRNA loaded DOTAP liposome vaccine administered intravenously (RNA loaded lipid particles, RNA-LPs). The registry lists allocation as randomized. The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 28 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.485Z"},{"nctId":"NCT04587739","title":"Neoadjuvant Hypofractionated Stereotactic Body Radiation Therapy Prior to Surgery for Hepatocellular Carcinoma: a Feasibility Study.","officialTitle":"A Pilot Study on the Feasibility and Tolerance of Neoadjuvant Hypofractionated, Stereotactic Body Radiation Therapy Prior to Surgical Resection of Uninodular Hepatocellular Carcinoma.","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Lille","sponsorClass":"OTHER","summary":"Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called \"microvascular invasion\".\n\nTo adequately deal with this phenomenon, the surgeon has to perform either an 'anatomical' liver resection, which remove not only the tumor but also the whole corresponding vascular network, or a 'tumorectomy' with resection margins of at least 2 cm. Unfortunately, these principles cannot always be achieved due to underlying liver cirrhosis that is present in more than 80% of patients.\n\nStereotactic body radiation therapy (SBRT) has been proven to efficiently necrotize or stabilize HCC nodules when surgery is not possible. Our hypothesis is that pre-treatment with SBRT prior to surgical resection of HCC might improve the results through the destruction of possible seeding in the peritumoral environment.\n\nGiven the novelty of this therapeutic strategy, it is necessary to verify its feasibility and safety, prior to test its efficacy in patients with HCC. The KARCHeR-1 study aims at making sure that preoperative SBRT would not result in important delays or serious adverse events such as to cancel the planned surgical resection, in patients who otherwise could have benefited from it. This issue is commonly called 'drop-out'. Thirty patients are expected to be included in the KARCHeR-1 study, which would be in favor of continuing to evaluate this therapeutic strategy if less than 3 drop-outs occur, and would be immediately discontinued if 3 drop-outs occur. Other outcomes will also been studied, like intraoperative issues, postoperative morbi-mortality, pathological features on the surgical specimen and its correlation with preoperative imaging, and finally, tumor recurrence and survival.","conditions":["Hepatocellular Carcinoma"],"keywords":["Hepatocellular carcinoma","Stereotactic body radiation therapy","Hepatectomy","Neoadjuvant therapy","Drop-out"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Surgery with Neoadjuvant stereotactic body radiation therapy"}],"enrollment":30,"startDate":"2021-01-31","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria\n* Single nodule, 3 to 8 cm of largest diameter\n* Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization\n\nExclusion Criteria:\n\n* Performance status \\> 2\n* Severe comorbidity with contraindication for either surgery or radiation therapy\n* Decompensated liver cirrhosis (Child-Pugh B or C)\n* Neoplastic portal vein thrombosis or extra-hepatic metastases\n* Previous anticancer therapy within the last 5 years","locations":[{"facility":"Hop Claude Huriez Chu Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emmanuel Boleslawski, MD,PhD","phone":"320444260","email":"emmanuel.boleslawski@chru-lille.fr"}],"primaryOutcomes":["Drop-out rate"],"hasResults":false,"conditionSlugs":["liver-cancer","als"],"drugSlugs":[],"locationSlugs":["lille-france"],"enrichment":{"headline":"Phase 1: Surgery with Neoadjuvant stereotactic body radiation therapy for Hepatocellular Carcinoma","inPlainEnglish":"Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called \"microvascular invasion\".","whoItsFor":["Ages 18 Years to 70 Years","Biopsy-proven hepatocellular carcinoma or EASL/AASLD criteria","Single nodule, 3 to 8 cm of largest diameter","Hepatocellular carcinoma eligible for conventional liver resection with curative intent (R0), without preoperative portal vein embolization"],"whoShouldSkip":["Performance status \\> 2","Severe comorbidity with contraindication for either surgery or radiation therapy","Decompensated liver cirrhosis (Child-Pugh B or C)","Neoplastic portal vein thrombosis or extra-hepatic metastases","Previous anticancer therapy within the last 5 years"],"whatHappens":"If you join, the listed intervention(s) are Surgery with Neoadjuvant stereotactic body radiation therapy. The registry lists allocation as na. Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Lille. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.635Z"},{"nctId":"NCT04589624","title":"An Investigational Scan (hpMRI) for Monitoring Treatment Response in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck Undergoing Radiation Therapy and/or Systemic Therapy","officialTitle":"Pilot Study of Metabolic Guidance for Therapy in Patients With Thyroid Cancer and Other Malignancies of the Head and Neck","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate. Diagnostic procedures, such as hpMRI, may predict a patient's response to treatment and may help plan the best treatment.","conditions":["Thyroid Gland Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Hyperpolarized Carbon C 13 Pyruvate"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"}],"enrollment":42,"startDate":"2020-08-12","completionDate":"2027-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Be willing and able to provide informed consent\n* Be informed of the investigational nature of this study\n* Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment\n\nExclusion Criteria:\n\n* Have a history of severe claustrophobia\n* Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)\n* Have a history of cardiac arrhythmia\n* Have an allergy to Gadavist intravenous contrast\n* Estimated glomerular filtration rate (eGFR) \\< 30\n* If female, be pregnant or breast feeding at time of consent","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephen Y Lai","phone":"713-792-6528","email":"sylai@mdanderson.org"}],"primaryOutcomes":["Metabolic imaging data from hyperpolarized magnetic resonance imaging (hpMRI) methods"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: testing Hyperpolarized Carbon C 13 Pyruvate for Thyroid Gland Carcinoma","inPlainEnglish":"This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate.","whoItsFor":["Ages 18 Years to any","Be informed of the investigational nature of this study","Be diagnosed with thyroid cancer and other malignancies of the head and neck with intent for treatment"],"whoShouldSkip":["Have a history of severe claustrophobia","Have electrically, magnetically or mechanically activated implants that would preclude magnetic resonance imaging (MRI)","Have a history of cardiac arrhythmia","Have an allergy to Gadavist intravenous contrast","Estimated glomerular filtration rate (eGFR) \\< 30","If female, be pregnant or breast feeding at time of consent"],"whatHappens":"If you join, the listed intervention(s) are Hyperpolarized Carbon C 13 Pyruvate, Magnetic Resonance Imaging, or Magnetic Resonance Imaging. The registry lists allocation as randomized. This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 42 people at Houston. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.325Z"},{"nctId":"NCT04606446","title":"Study of PF-07248144 in Advanced or Metastatic Solid Tumors","officialTitle":"A PHASE 1/2A DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETIC, PHARMACODYNAMIC, AND ANTI-TUMOR ACTIVITY OF PF-07248144 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with other agents","conditions":["Locally Advanced or Metastatic ER+ HER2- Breast Cancer","Locally Advanced or Metastatic Castration-resistant Prostate Cancer","Locally Advanced or Metastatic Non-small Cell Lung Cancer"],"keywords":["Solid tumors"],"interventions":[{"type":"DRUG","name":"PF-07248144"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"PF-07220060"},{"type":"DRUG","name":"PF-07850327, ARV-471, vepdegestrant"}],"enrollment":320,"startDate":"2020-11-16","completionDate":"2029-08-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Disease Characteristics - Breast, Prostate, and Lung Cancer\n* Part 1A (Monotherapy Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available.\n* Part 1B, Part 1C, Part 1D and Part 1E (Combination Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting.\n* Part 2A (ER+HER2- breast cancer 2L+, monotherapy) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4/6 inhibitor and 1 line of endocrine therapy.\n* Part 2B (ER+HER2- breast cancer 2-4L, combination with fulvestrant) Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy.. Participants must not have received more than 3 prior lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant.\n* Part 2D (ER+HER2- breast cancer 2-4L, combination with PF-07220060 (CDK4i) and fulvestrant):\n\nHistological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy.\n\n* Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant.\n* Part 2E (ER+HER2- breast cancer 2-4L, combination with vepdegestrant): Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy; Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have received fulvestrant\n* Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards.\n* Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of HER2-negative tumor: HER2-negative tumor is determined as immunohistochemistry score 0/1+ or negative by in situ hybridization (FISH/CISH/SISH/DISH) defined as a HER2/CEP17 ratio \\<2 or for single probe assessment a HER2 copy number \\<4.\n* Female participants with ER+HER2- advanced or metastatic breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause by treatment with the approved LHRH agonist such as goserelin, leuprolide or equivalent agents to induce chemical menopause.\n* Female participants with ER+HER2- advanced or metastatic breast cancer of nonchildbearing potential must meet at least 1 criteria of achieving postmenopausal status.\n* Participants must have at least 1 measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status PS 0 or 1\n* Female or male patients aged ≥ 18 years (Japan ≥ 20 years) (South Korea ≥ 19 years).\n* Adequate renal, liver, and bone marrow function.\n* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade 1 except for adverse events (AEs) not constituting a safety risk by investigator judgment.\n\nExclusion Criteria:\n\n* Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor).\n* Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.\n* Major surgery, radiation therapy, or systemic anti-cancer therapy within 3 weeks prior to study entry.\n* Prior irradiation to \\>25% of the bone marrow.\n* ECG clinically relevant abnormalities (eg, QTc \\>470 msec, complete LBBB, second/third degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia).\n* Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor.\n* Known or suspected hypersensitivity or severe allergy to active ingredient/excipients of PF-07248144.\n* Active inflammatory GI disease, refractory and unresolved chronic diarrhea or previous gastric resection, lap band surgery or other GI conditions and surgeries that may significantly alter the absorption of PF-07248144 tablets. Gastroesophageal reflux disease under treatment is allowed.\n* Pregnant or breastfeeding female participants.","locations":[{"facility":"HonorHealth","city":"Scottsdale","state":"Arizona","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Cedars-Sinai Cancer at Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center at Mission Bay","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital at Yale - New Haven","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale-New Haven Hospital- Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Phase 1 Unit","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"St. Elizabeth Healthcare","city":"Edgewood","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center, lnc.:DBA University of Louisville Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UofL Health Brown Cancer Center","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson The Woodlands","city":"Conroe","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas M. D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"U.T. MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson West Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson League City","city":"League City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chris O'Brien Lifehouse","city":"Camperdown","state":"New South Wales","country":"Australia","status":"TERMINATED","lat":null,"lon":null},{"facility":"Cancer Research South Australia","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Melbourne Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western Health-Sunshine & Footscray Hospitals","city":"St Albans","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. John of God Subiaco Hospital","city":"Subiaco","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUN Yat-Sen University Cancer Center","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jilin Province Tumor Hospital","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kanagawa cancer center","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyungpook National University Chilgok Hospital","city":"Daegu","state":"Taegu-kwangyǒkshi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of participants with dose-limiting toxicities in the Dose Escalation Arms.","Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Escalation Arms.","Safety and Tolerability through monitoring of laboratory assessments for participants enrolled in the Dose Escalation Arms.","Safety and Tolerability as assessed by adverse event monitoring for participants enrolled in the Dose Expansion Arms","Safety and Tolerability through monitoring of laboratory assessments for participants enroled in the Dose Expansion Arms"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["scottsdale-arizona","los-angeles-california","san-francisco-california","new-haven-connecticut","fort-lauderdale-florida","edgewood-kentucky","louisville-kentucky","nashville-tennessee","conroe-texas","houston-texas","league-city-texas","san-antonio-texas","sugar-land-texas","seattle-washington","camperdown-australia","adelaide-australia","melbourne-australia","parkville-australia","st-albans-australia","subiaco-australia","beijing-china","guangzhou-china","changchun-china","xian-china","nagoya-japan","kashiwa-japan","yokohama-japan","chuo-ku-japan","seongnam-si-south-korea","seoul-south-korea","daegu-south-korea"],"enrichment":{"headline":"Phase 2: testing PF-07248144 for Locally Advanced or Metastatic ER+ HER2- Breast Cancer","inPlainEnglish":"This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical how well it works of PF-07248144 as a single agent and in combination with other agents","whoItsFor":["Ages 18 Years to any","Disease Characteristics - Breast, Prostate, and Lung Cancer","Part 1A (this drug alone Dose Escalation) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer, CRPC, or NSCLC that is intolerant or resistant to standard therapy or for which no standard therapy is available","Part 2A (ER+HER2- breast cancer 2L+, this drug alone) Histological or cytological diagnosis of locally advanced or metastatic ER+HER2- breast cancer. Participants must have progressed after at least 1 prior line of CDK4/6 inhibitor and 1 line of endocrine therapy","Part 2D (ER+HER2- breast cancer 2-4L, combination with PF-07220060 (CDK4i) and fulvestrant):","Histological or cytological diagnosis of advanced or metastatic ER+HER2- breast cancer. Participants must have progressive disease after at least 1 prior line of a CDK4/6 inhibitor and at least 1 prior line of endocrine therapy","Participants must have not received more than 3 lines of systemic therapies including up to 1 line of cytotoxic chemotherapy for visceral disease in advanced or metastatic setting; Participants may have but are not required to have prior treatment with fulvestrant","Participants with ER+HER2- advanced or metastatic breast cancer must have documentation of ER-positive tumor (≥1% positive stained cells) based on most recent tumor biopsy utilizing an assay consistent with local standards"],"whoShouldSkip":["Unmanageable ascites (limited medical treatment to control ascites is permitted, but all participants with ascites require review by sponsor's medical monitor)","Participants with any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ","Major surgery, radiation therapy, or systemic anti-cancer therapy within 3 weeks prior to study entry","Prior irradiation to \\>25% of the bone marrow","ECG clinically relevant abnormalities (eg, QTc \\>470 msec, complete LBBB, second/third degree AV block, ST elevation or EKG changes suggesting myocardial infarction or active myocardia ischemia)","Therapeutic anticoagulation. However, low molecular weight heparin is allowed. Vitamin K antagonists or factor Xa inhibitors may be allowed following discussion with the Sponsor","Known or suspected hypersensitivity or severe allergy to active ingredient/excipients of PF-07248144"],"whatHappens":"If you join, the listed intervention(s) are PF-07248144, Fulvestrant, or Letrozole. The registry lists allocation as randomized. This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical how well it works of PF-07248144 as a single agent and in combination with other agents","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 320 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.719Z"},{"nctId":"NCT04616560","title":"Trastuzumab Deruxtecan (DS-8201a) for the Treatment of Recurrent or Refractory Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","officialTitle":"A Phase 1/2 Study of DS-8201a (NSC# 807708) in Children, Adolescents, or Young Adults With Recurrent Osteosarcoma, Wilms Tumor, and Desmoplastic Small Round Cell Tumor","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them.","conditions":["Desmoplastic Small Round Cell Tumor","Osteosarcoma","Recurrent Desmoplastic Small Round Cell Tumor","Recurrent Kidney Wilms Tumor","Recurrent Osteosarcoma","Refractory Desmoplastic Small Round Cell Tumor","Refractory Wilms Tumor","Wilms Tumor"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":55,"startDate":"2021-03-08","completionDate":"2027-12-31","sex":"ALL","minAge":"12 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment\n* Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment\n\n  * Until the completion of the Phase 1 dose confirmation, patients must be at least 12 years of age and less than 18 years of age at the time of study enrollment\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, Wilms tumor patients at least 2 to less than 18 years of age will be allowed on the Phase 2 component\n* Phase 2: DSRCT patients (Part B2): Until the completion of the Phase 1 component, patients enrolling on the Phase 2 component of the study must be from at least 12 to 39 years of age at the time of study enrollment\n\n  * Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, DSRCT patients at least 2 to 39 years of age will be allowed on the Phase 2 component\n* Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse\n* Solid tumors: Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients with clinically inactive brain metastases may be included in the study. Patients with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Lastly, patient must have unresectable lesions or lesions with no intention to surgically remove the lesions in the 6 months following enrollment\n* Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:\n\n  * Relapse after initial treatment with 4 or more chemotherapy agents (e.g. Regimens vincristine, dactinomycin, doxorubicin, cyclophosphamide, etoposide and radiation \\[M\\], vincristine, dactinomycin and doxorubicin, vincristine, and irinotecan \\[MVI\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide and radiation \\[UH-1\\], doxorubicin, vincristine, cyclophosphamide, carboplatin, etoposide, vincristine, and irinotecan \\[UH-2\\], vincristine, irinotecan, cyclophosphamide, carboplatin, etoposide and doxorubicin \\[UH-3\\], and etoposide, carboplatin, cyclophosphamide, and doxorubicin \\[HR-1\\])\n  * Relapse with high risk histology (anaplasia, blastemal predominant)\n  * Multiple relapses\n* Desmoplastic small round cell tumor: DSRCT patients with relapsed or refractory disease are eligible\n* Patient's current disease state must be one for which they have received at least standard initial therapy, defined as systemic therapy combined with either radiation or surgery for local control of the primary tumor at diagnosis. Prior therapy after relapse is not required\n* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0 or 1. Use Karnofsky for patients older than 16 years of age and Lansky for patients 16 years of age and younger\n* Patients must have recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately\n\n  * Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive: For agents not listed, the duration of this interval must be discussed with the study chair and the study-assigned Research Coordinator prior to enrollment\n\n    * \\>= 21 days after the last dose of myelosuppressive chemotherapy (42 days if prior nitrosourea)\n  * Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): \\>= 7 days after the last dose of agent\n  * Antibodies: \\>= 4 weeks (28 days) must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =\\< 1\n  * Corticosteroids\n  * Hematopoietic growth factors: \\>= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur\n  * Interleukins, interferons and cytokines (other than hematopoietic growth factors): \\>= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n  * Stem cell Infusions (with or without total body irradiation \\[TBI\\]):\n\n    * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: \\>= 84 days after infusion and no evidence of graft versus host disease (GVHD)\n    * Autologous stem cell infusion including boost infusion: \\>= 30 days\n  * Cellular therapy: \\>= 30 days after the completion the infusion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells, etc.)\n  * Radiation therapy (XRT)/external beam irradiation including protons: \\>= 4 weeks (28 days) including palliative radiation therapy to the chest. \\>= 14 days after palliative local XRT to areas other than the chest or for whole brain radiotherapy\n  * Radiopharmaceutical therapy (e.g., radiolabeled antibody, samarium): \\>= 42 days after systemically administered radiopharmaceutical therapy\n  * Patients must not have received prior HER2 therapies including antibody drug conjugates (e.g. TDM-1 or DS-8201a), HER2 directed cellular therapies, HER2 receptor therapy (e.g. trastuzumab, pertuzumab, margetuximab, zanidatamab, zenocutuzumab) or small molecule antagonists of HER2 (e.g lapatinib, tucatinib, or neratinib). Prior exposure to antibody drug conjugates which do not target HER2 as well as prior treatment with topoisomerase 1 inhibitors (e.g. irinotecan, topotecan) are permitted\n* Patients must be at least 14 days from the date of last surgery\n* Peripheral absolute neutrophil count (ANC) \\>= 1000/uL, (for patients with solid tumors without known bone marrow involvement)\n* Platelet count \\>= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* Hemoglobin \\>= 8.0 g/dL at baseline (Red Blood Cell transfusion is not allowed within 1 week prior to enrollment) (for patients with solid tumors without known bone marrow involvement)\n* For patients less than or equal to 17 years old, \"Bedside\" Schwartz formula (2009)\n* Estimated glomerular filtration rate (GFR) (eGFR) ≥ 70 mL/min/1.73 m\\^2 (\\> 70mL/min/1.73 m\\^2 for patients \\> 17 years old)\n\n  * For patients older than 17 years of age the Cockroft-Gault equation should be utilized to calculate creatinine clearance ≥ 70 ml/min:\n  * OR for any age group:\n\n    * A 24 hour urine creatinine clearance ≥ 70 mL/min/1.73 m\\^2 (\\> 70mL/min for patients ≥ 17 years old) OR\n    * A directly measured GFR ≥ 70 mL/min/1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n* Bilirubin (sum of conjugated + unconjugated or total) =\\< 1.5 x upper limit of normal (ULN) for age. For patients with documented Gilbert's syndrome (unconjugated hyperbilirubinemia) bilirubin must be \\< 3 x ULN for age (patients with solid tumors)\n* Aspartate aminotransferase (AST) =\\< 3 x ULN\n* Serum albumin \\>= 2.5 g/dL (patients with solid tumors)\n* International normalized ratio (INR)/prothrombin time (PT) =\\< 1.5 x ULN. Exception for patients receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have INR/PT within the therapeutic range as deemed appropriate by the investigator\n* Shortening fraction of \\>= 27% by echocardiogram, or ejection fraction of \\>= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before Step 1 enrollment\n* Corrected QT interval (QTc) prolongation to \\< 480 ms based on average triplicate 12-lead electrocardiogram (ECG)\n* Pulse oximetry \\> 93% on room air\n* Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled as evidenced by no increase in seizure frequency in the prior 7 days\n* Nervous system disorders (Common Terminology Criteria for Adverse Events \\[CTCAE\\] version \\[v\\]5) resulting from prior chemotherapy, surgery, and/or radiation must be =\\< grade 2, with the exception of decreased tendon reflex (DTR). Any grade of DTR is eligible\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of enrollment are eligible\n* All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant, or breast-feeding women will not be entered on this study. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (e.g., male or female condom) for the duration of the study and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug. Abstinence is an acceptable method of birth control\n\n  * Methods considered as highly effective methods of contraception include:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Intravaginal\n      * Transdermal\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Injectable\n      * Implantable\n    * Intrauterine device (IUD)\n    * Intrauterine hormone-releasing system (IUS)\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Complete sexual abstinence defined as refraining from heterosexual intercourse. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not an acceptable method of contraception\n* Non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU/mL and estradiol \\< 40 pg/mL \\[\\< 147 pmol/L\\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at enrollment and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of enrollment and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Patients receiving corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. If used to modify immune adverse events related to prior therapy, \\>= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients who are receiving chloroquine or hydroxychloroquine within 14 days are not eligible for this trial\n* Patients who received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to enrollment are not eligible for this trial\n\n  * Note: Participants, if enrolled, should not receive live vaccines during the study and up to 90 days after the last dose of study intervention. It is recommended that patients receive a yearly influenza killed vaccination and additional killed vaccinations based on local or national recommendations. Consider vaccination against viral pathogens that cause pneumonias according to local or national guidelines\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients with a medical history of myocardial infarction within 180 days before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) or troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment are not eligible\n* Additionally, patients with a history of any of the following congenital heart disease are not eligible:\n\n  * Single ventricle heart defects (hypoplastic left heart syndrome, unbalanced atrioventricular septal defects, double inlet left ventricle, tricuspid atresia, the presence of superior cavopulmonary anastomosis or Fontan palliation);\n  * Unpalliated defects with significant hemodynamic alterations or palliated lesions with residual hemodynamic alterations (ductal-dependent or shunt-dependent physiology, large unrestrictive ventricular septal defect, transposition of the great arteries, greater than moderate atrioventricular valve insufficiency, moderate or greater aortic valve stenosis, moderate or greater aortic valve insufficiency, large atrial septal defects with significant right ventricular volume overload, large patent ductus arteriosus)\n* Patients who have a pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART) are not eligible. (Drainage and concentrated ascites reinfusion therapy are not allowed within 2 weeks prior to enrollment)\n* Patients who have spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms are not eligible\n* Patients with a known history of severe hypersensitivity to DS-8201a, any excipient contained in the DS-8201a drug formulation, or HER2-targeted monoclonal antibodies (trastuzumab, pertuzumab, margetuximab) are not eligible\n* Patients who have an uncontrolled infection or non-healing surgical site are not eligible\n* Patients with a known history of substance abuse or any other clinically significant medical conditions (i.e. psychological conditions) that may, in the opinion of the investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results are not eligible\n* Patients who have pulmonary compromise, ex hypoxia, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), or prior pneumonectomy are not eligible\n* Patients who have a history of (non-infectious) ILD (interstitial lung disease)/pneumonitis that required steroids, has current ILD/pneumonitis, or for whom suspected ILD/pneumonitis cannot be ruled out by imaging at screening are not eligible. Patients who have history of genetic disorders of the lung (i.e. cystic fibrosis are not eligible)\n* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study are not eligible\n* Patients with known hepatitis B or C with detectable viral load are not eligible\n* Patients with any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of enrollment or genetic diseases involving the lung are not eligible\n* Patients with an active primary immunodeficiency are not eligible","locations":[{"facility":"Children's Hospital of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Orange County","city":"Orange","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Lucile Packard Children's Hospital Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center-Mission Bay","city":"San Francisco","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Children's National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins All Children's Hospital","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta - Arthur M Blank Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lurie Children's Hospital-Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of Chicago Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children","city":"Indianapolis","state":"Indiana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Johns Hopkins University/Sidney Kimmel Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"C S Mott Children's Hospital","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota/Masonic Cancer Center","city":"Minneapolis","state":"Minnesota","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Children's Mercy Hospitals and Clinics","city":"Kansas City","state":"Missouri","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Medical College","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Pittsburgh of UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University/Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern/Simmons Cancer Center-Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Primary Children's Hospital","city":"Salt Lake City","state":"Utah","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Maximum tolerated dose and/or recommended phase 2 dose of DS-8201a in children at least 2 to less than 12 years old with recurrent or refractory Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) (Phase 1)","Incidence of adverse events (AEs) in children at least 2 to less than 12 years old with recurrent or refractory WT or DSRCT (Phase 1)","Time to progression"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["birmingham-alabama","los-angeles-california","orange-california","palo-alto-california","san-francisco-california","aurora-colorado","washington-d-c-district-of-columbia","st-petersburg-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","minneapolis-minnesota","kansas-city-missouri","st-louis-missouri","new-york-new-york","valhalla-new-york","durham-north-carolina","cincinnati-ohio","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","memphis-tennessee","nashville-tennessee","dallas-texas","houston-texas","salt-lake-city-utah","seattle-washington"],"enrichment":{"headline":"Phase 2: testing Trastuzumab Deruxtecan for Desmoplastic Small Round Cell Tumor","inPlainEnglish":"This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory). Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates.","whoItsFor":["Ages 12 Years to 39 Years","Phase 1 (Part A): Patients must be at least 2 years and less than 12 years of age at the time of study enrollment","Phase 2: Wilms tumor patients (Part B1): All Wilms tumor patients enrolled must be less than 18 years of age at enrollment","Until the completion of the Phase 1 dose confirmation, patients must be at least 12 years of age and less than 18 years of age at the time of study enrollment","Following dose confirmation of DS-8201a in children at least 2 to less than 12 years old in the Phase 1 component, Wilms tumor patients at least 2 to less than 18 years of age will be allowed on the Phase 2 component","Phase 2: DSRCT patients (Part B2): Until the completion of the Phase 1 component, patients enrolling on the Phase 2 component of the study must be from at least 12 to 39 years of age at the time of study enrollment","Patients must have had histologic verification of Wilms tumor or desmoplastic small round cell tumor at original diagnosis or relapse","Wilms tumor: WT patients must have either refractory disease or a very high risk relapse, defined as ANY of the following:"],"whoShouldSkip":["Methods considered as highly effective methods of contraception include:","Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:","Progestogen-only hormonal contraception associated with inhibition of ovulation:","Intrauterine device (IUD)","Intrauterine hormone-releasing system (IUS)","Bilateral tubal occlusion","Vasectomized partner"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Echocardiography Test. The registry lists allocation as na. This phase I/II trial studies the effects of trastuzumab deruxtecan (DS-8201a) in treating patients with osteosarcoma, Wilms tumor (WT) or desmoplastic small round cell tumor (DSRCT) that is newly diagnosed or has come back after a period of improvement (recurrent) or that has not responded to previous treatment (refractory).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 55 people at 32 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.345Z"},{"nctId":"NCT04628767","title":"Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer","officialTitle":"A Phase II/III Trial of Durvalumab and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as methotrexate, vinblastine, doxorubicin, cisplatin, and gemcitabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab in combination with chemotherapy before surgery may enhance the shrinking of the tumor compared to chemotherapy alone.","conditions":["Renal Pelvis and Ureter Urothelial Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Doxorubicin Hydrochloride"},{"type":"BIOLOGICAL","name":"Durvalumab"},{"type":"DRUG","name":"Gemcitabine Hydrochloride"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Methotrexate"},{"type":"BIOLOGICAL","name":"Pegfilgrastim"},{"type":"PROCEDURE","name":"Therapeutic Conventional Surgery"},{"type":"DRUG","name":"Vinblastine Sulfate"}],"enrollment":131,"startDate":"2021-11-12","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1 REGISTRATION AND RANDOMIZATION\n* Patients must be \\>= 18 years of age\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible\n* Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following:\n\n  * Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy\n  * High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy\n\n    * NOTE: Universal histologic testing of UTUC with additional studies, such as immunohistochemistry and/or microsatellite instability, is strongly recommended to identify patients with high probability of Lynch-related or other germline mutation related cancers whom clinicians should refer for genetic counseling and germline testing (this is not required for eligibility)\n\n      * Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible\n* Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\\>= 50%) subtype is conventional urothelial carcinoma\n* Leukocytes \\>= 3,000/mcL (obtained =\\< 14 days prior to registration/randomization)\n* Platelets \\>= 100,000/mcL (obtained =\\< 14 days prior to registration/randomization)\n* Total bilirubin =\\< 1.2 mg/dL (or ≤ 2 mg/dL for patients with Gilbert's disease)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2 x institutional ULN (obtained =\\< 14 days prior to registration/randomization)\n* Hemoglobin (Hgb) \\>= 9 g/dL (obtained =\\< 14 days prior to registration/randomization)\n\n  * NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator\n* Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients of childbearing potential and sexually active patients must not expect to conceive or father children, either by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment\n* Patients must have no evidence of metastatic disease or clinically enlarged regional lymph nodes (\\>= 1.5 cm short axis) on imaging required within 28 days prior to registration (Non-regional findings \\>=1.5 cm short axis that in the opinion of the investigator are not concerning for involvement based on radiographic characteristics, chronicity, avidity on positron emission tomography (PET) scan or other imaging or other criteria can be eligible based on investigator discretion).\n\n  * NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness can also undergo baseline bone scan to evaluate for bone metastasis at the discretion of local provider.\n* Patient must meet below criteria for prior/current malignancy history:\n\n  * Non-urothelial cancer malignancy history:\n\n    * Patient must not have another active (or within two years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g. =\\< Gleason 3+4) on active surveillance (or watchful waiting) or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat\n\n      * NOTE: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n    * Urothelial cancer malignancy history:\n\n      * Patient may have a history of resectable urothelial cancer as long as patients meet one of the following:\n      * T0, Ta or Tis at any time\n      * T1-4a N0 and no evidence of disease (NED) for more than 2 years from the latest therapy \\[e.g., radical surgery, transurethral resection of bladder tumor (TURBT), radiation, chemotherapy (neoadjuvant or adjuvant, or with radiation)\\]. Prior systemic immune checkpoint inhibitor is not allowed.\n      * Patient with history of \\>= pT4b, N+, and/or M1 UC is not eligible.\n      * NOTE: Patients in whom concomitant or prior bladder/urethra predominant (\\>= 50%) urothelial carcinoma have been surgically resected and demonstrated to be only Ta or carcinoma in situ (CIS) (\\< cT1 N0) are eligible regardless of time elapsed\n* Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, clinically relevant liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations in the three months prior to registration that would limit compliance with study requirements\n* Patient must not have received prior radiation therapy to \\>= 25% of the bone marrow for other diseases\n* Patient must not have received prior systemic anthracycline therapy\n\n  * NOTE: Patients who have received prior intravesical therapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible\n* Patient must not have either history of or active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration/randomization or any history of inflammatory bowel disease (inflammatory bowel disease \\[IBD\\], e.g. ulcerative colitis, or Crohn's disease), neuromuscular autoimmune condition, immune-related pneumonitis or interstitial lung disease. Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition are eligible\n* Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of durvalumab. The following are exceptions to this criterion and are allowed:\n\n  * Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g. intra-articular injection\n  * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment\n  * Steroids as pre-medications for hypersensitivity reactions (e.g. computed tomography \\[CT\\] pre-medication)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration/randomization are eligible for this trial\n\n  * NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count \\< 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months\n  * NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count \\< 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count \\>= 250 cells/mcL within 7 days of registration/randomization\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must not have received live attenuated vaccine within 30 days prior to the first dose of durvalumab, while on protocol treatment and within 30 days after the last dose of durvalumab\n* Patient must not have had a major surgical procedure within 28 days prior to registration/randomization\n\n  * NOTE: Cystoscopy/ureteroscopy/TURBT, stent placement or nephrostomy tube is not considered major surgery\n* Patient must not have history of allogenic organ transplantation\n* Patient must have a body weight of \\> 30 kg\n* Patient must have life expectancy of \\>= 12 weeks\n* Patient must have creatinine clearance \\> 15 ml/min as estimated by Cockcroft-Gault formula or glomerular filtration rate (GFR) \\> 15 ml/min/1.73m\\^2 within 28 days prior to registration/randomization\n\n  * NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and/or hearing loss in keeping with recommended cisplatin contraindications. Patients who are cisplatin-eligible will be randomized to either Arm A or Arm B and patients who are cisplatin-ineligible will be registered to Arm C\n\n    * Patients that meet any of the following four criteria will be registered to the cisplatin-ineligible Arm C if they meet other eligibility criteria:\n\n      * Creatinine clearance \\> 15 ml/min and =\\< 50 ml/min (estimated by Cockcroft-Gault formula) or GFR \\> 15ml/min/1.73m\\^2 and ≤ 50 ml/min/1.73 m\\^2\n      * Hearing loss \\>= 3\n      * Neuropathy \\>= 2\n      * ECOG performance status 2\n    * In addition, the patient must have an absolute neutrophil count (ANC) \\>= 1,000/mcL obtained =\\< 14 days prior to registration\n    * Patients that meet all of the following four criteria will be randomized to the cisplatin-eligible Arm A or Arm B:\n\n      * Creatinine clearance \\> 50ml/min (estimated by Cockcroft-Gault formula) or GFR \\> 50ml/min/1.73m\\^2\n      * ECOG performance status 0-1\n      * Hearing loss grade 0-2\n      * Neuropathy 0-1\n    * In addition, the patient must have an absolute neutrophil count (ANC) \\>= 1,500/mcL obtained =\\< 14 days prior to randomization\n    * Also, the patient must have left ventricular ejection fraction (LVEF) \\>= 50% by (either multigated acquisition scan \\[MUGA\\] or 2-D echocardiogram) obtained within obtained within 28 days prior to randomization","locations":[{"facility":"Kingman Regional Medical Center","city":"Kingman","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sutter Auburn Faith Hospital","city":"Auburn","state":"California","country":"United 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States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Event-free survival (EFS) (Cisplatin eligible cohort: Arms A and B)","Pathologic complete response (pCR) (Cisplatin ineligible cohort: Arm 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2 / Phase 3: testing Cisplatin for Renal Pelvis and Ureter Urothelial Carcinoma","inPlainEnglish":"This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","STEP 1 REGISTRATION AND RANDOMIZATION","Patients must be \\>= 18 years of age","Patient must have a diagnosis of high grade upper tract urothelial carcinoma expected within 14 weeks (98 days) prior to registration/randomization with one of the following:","Biopsy (gold standard, preferred) and either upper urinary tract mass on cross-sectional imaging or tumor directly visualized during upper urinary tract endoscopy","High grade cytology and clinically estimated invasive upper urinary tract mass on cross-sectional imaging (e.g., including presence of tumor-related hydronephrosis) or tumor directly visualized during upper urinary tract endoscopy","Due to the anatomy of upper urinary tract and lack of muscularis propria, pathologic evidence of cT2 on biopsy is usually not possible","Patients must not have any component of small cell/neuroendocrine carcinoma. Other histologic subtypes (variants) are permitted provided the half or predominant (\\>= 50%) subtype is conventional urothelial carcinoma"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Cisplatin. The registry lists allocation as randomized. This phase II/III trial compares the effect of adding durvalumab to chemotherapy versus chemotherapy alone before surgery in treating patients with upper urinary tract cancer.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 131 people at 258 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.076Z"},{"nctId":"NCT04631042","title":"Developing Brain, Impulsivity and Compulsivity","officialTitle":"An Observational Study of the Developing Brain, Impulsivity and Compulsivity","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.","conditions":["Typical Development","Obsessive Compulsive Disorder","Conduct Disorder","Attention Deficit Hyperactivity Disorder","Autism Spectrum Disorder"],"keywords":["Neurodevelopmental disorder","Twin","Natural History","Heritability","Glutamate","developmental trajectory","Brain Connectivity"],"interventions":[],"enrollment":1100,"startDate":"2022-09-30","completionDate":"2030-12-31","sex":"ALL","minAge":"6 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tonya J White, M.D.","phone":"(301) 496-5192","email":"tonya.white@nih.gov"}],"primaryOutcomes":["Glutamate concentration measured using Magnetic Resonance Spectroscopy","Heritability of cortical glutamate (proportion of variance explained by additive genetic factors)."],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Developing Brain, Impulsivity and Compulsivity","inPlainEnglish":"Background: Impulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. 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The registry lists allocation as na. This study wants to assess long term safety in participants who have completed a Novartis trial with secukinumab, have been judged by the investigator to benefit from continued treatment with secukinumab, and are unable to obtain the marketed secukinumab formulation.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,000 people at 139 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.969Z"},{"nctId":"NCT04649242","title":"Randomized Study in Children and Adolescents With Migraine: Acute Treatment","officialTitle":"Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.","conditions":["Pediatric Migraine"],"keywords":["Migraine","Acute treatment","Phonophobia","Photophobia","Nausea","Pediatric","Children","Adolescent","Pediatric Migraine"],"interventions":[{"type":"DRUG","name":"Rimegepant/BHV3000"},{"type":"DRUG","name":"Matching placebo"}],"enrollment":2100,"startDate":"2021-01-15","completionDate":"2029-01-09","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. History of migraine (with or without aura) for \\> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \\> 3 hours without treatment, and attacks occurring at intervals \\> 24 hours.\n3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.\n\n   1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \\[biologic or small molecule\\], during the treatment phases.\n   2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.\n   3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.\n4. Verbally distinguish between migraine and other types of headaches.\n5. Participants must have a weight \\> 40 kg at the Screening Visit.\n6. Adequate venous access for blood sampling.\n7. Male and female participants ≥ 6 to \\< 18 years of age (participants must not reach their 18th birthday during the study).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.\n3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.\n4. History of suicidal behavior or major psychiatric disorder.\n5. Current diagnosis or history of substance abuse; positive drug test at Screening.\n6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.\n7. Recent or planned surgery, requiring general anesthesia, \\<8 weeks prior to the Screening Visit.\n8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).\n9. Current diagnosis of viral hepatitis or a history of liver disease.\n10. 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pain."],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","scottsdale-arizona","tempe-arizona","anaheim-california","costa-mesa-california","culver-city-california","fountain-valley-california","fresno-california","la-jolla-california","long-beach-california","los-angeles-california","north-hollywood-california","orange-california","pomona-california","sacramento-california","san-bernardino-california","upland-california","walnut-creek-california","aurora-colorado","colorado-springs-colorado","cromwell-connecticut","hartford-connecticut","stamford-connecticut","wilmington-delaware","washington-d-c-district-of-columbia","apopka-florida","cutler-bay-florida","deland-florida","gainesville-florida","lake-city-florida","lakeland-florida","miami-florida","naples-florida","orange-park-florida","orlando-florida","pembroke-pines-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","brunswick-georgia","decatur-georgia","chicago-illinois","naperville-illinois","westfield-indiana","sioux-city-iowa","west-des-moines-iowa","kansas-city-kansas","overland-park-kansas","lexington-kentucky","new-orleans-louisiana","shreveport-louisiana","boston-massachusetts","waltham-massachusetts","ann-arbor-michigan","grand-rapids-michigan","kalamazoo-michigan","royal-oak-michigan","rochester-minnesota","flowood-mississippi","ozark-missouri","springfield-missouri","great-falls-montana","kalispell-montana","missoula-montana","lincoln-nebraska","omaha-nebraska","neptune-city-new-jersey","amherst-new-york","commack-new-york","great-neck-new-york","lake-success-new-york","mineola-new-york","new-york-new-york","port-jefferson-station-new-york","rochester-new-york","the-bronx-new-york","charlotte-north-carolina","greensboro-north-carolina","akron-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","north-canton-ohio","oklahoma-city-oklahoma","tulsa-oklahoma","grants-pass-oregon","portland-oregon","philadelphia-pennsylvania","east-greenwich-rhode-island","greenville-south-carolina","kingsport-tennessee","memphis-tennessee","nashville-tennessee","austin-texas","bellaire-texas","dallas-texas","el-paso-texas","frisco-texas","houston-texas","plano-texas","salt-lake-city-utah","burlington-vermont","charlottesville-virginia","norfolk-virginia","richmond-virginia","bellevue-washington","everett-washington","seattle-washington","kenosha-wisconsin","madison-wisconsin","kelowna-bc-canada","sherbrooke-canada","bengbu-china","hefei-china","beijing-china","chongqing-china","lanzhou-china","shenzhen-china","haikou-china","shijiazhuang-china","zhengzhou-china","jingzhou-china","wuhan-china","changsha-china","lianyungang-china","suzhou-china","wuxi-china","xuzhou-china","zhenjiang-china","changchun-china","yinchuan-china","xian-china","xianyang-china","jinan-china","liaocheng-china","chengdu-china","hangzhou-china","ningbo-china","wenzhou-china","luan-china","shanghai-china","shenyang-china","shihezi-china","kasuga-shi-japan","kiryu-shi-japan","higashinada-ku-kobe-shi-japan","nishinomiya-shi-japan","mito-japan","kagoshima-japan","taihaku-ku-sendai-shi-japan","abeno-ku-osaka-shi-japan","naniwa-ku-japan","shibuya-ku-japan","shinjuku-ku-japan","hiroshima-japan","col-roma-norte-mexico","culiac-n-mexico","tlalnepantla-mexico","chihuahua-city-mexico","wroclaw-poland","katowice-poland","krakow-poland","poznan-poland","szczecin-poland","santander-spain","barcelona-spain","madrid-spain","seville-spain","valladolid-spain","lund-sweden","rebro-sweden","stockholm-sweden","leicester-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Rimegepant/BHV3000 for Pediatric Migraine","inPlainEnglish":"This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.","whoItsFor":["Ages 6 Years to 17 Years","History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \\> 3 hours without treatment, and attacks occurring at intervals \\> 24 hours","Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study","Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \\[biologic or small molecule\\], during the treatment phases","Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited","Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit","Verbally distinguish between migraine and other types of headaches","Participants must have a weight \\> 40 kg at the Screening Visit"],"whoShouldSkip":["History of cluster headache or hemiplegic migraine headache","Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study","Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania","History of suicidal behavior or major psychiatric disorder","Current diagnosis or history of substance abuse; positive drug test at Screening","History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning","Recent or planned surgery, requiring general anesthesia, \\<8 weeks prior to the Screening Visit"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant/BHV3000, or Matching placebo. The registry lists allocation as randomized. This study wants to test the safety and how well it works of BHV-3000 versus dummy treatment (placebo) in the acute treatment of moderate or severe migraine in children and adolescents.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,100 people at 245 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.300Z"},{"nctId":"NCT04650321","title":"Home Based Infusions for Ocrelizumab","officialTitle":"Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"The goal is to assess the safety and effectiveness of home ocrelizumab infusion.","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ocrelizumab at home"}],"enrollment":110,"startDate":"2021-03-01","completionDate":"2021-08-31","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Current active patient of Rocky Mountain MS Center at the time of final study consent.\n* Between 18-55 years of age at the time of final study consent.\n* Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19\n* Has at minimum completed their first 600 mg dose of ocrelizumab.\n* Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent.\n* Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20\n* Can complete patient reported outcomes developed and validated as English written scales.\n* Must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and FDA regulatory requirements.\n* Whose treating neurologist at the RMMSC feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent.\n\nExclusion Criteria:\n\n* Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion.\n* Has previously not participated in the SaROD trial at the RMMSC site.\n* Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC.","locations":[{"facility":"Amerita","city":"Centennial","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brooke Valdez, BS","phone":"303-724-2635","email":"brooke.valdez@cuanshutz.edu"}],"primaryOutcomes":["Severe infusion reactions","Infusion reactions"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["centennial-colorado"],"enrichment":{"headline":"Phase 4: testing Ocrelizumab at home for Multiple Sclerosis","inPlainEnglish":"The goal is to assess the safety and effectiveness of home ocrelizumab infusion.","whoItsFor":["Ages 18 Years to 55 Years","Current active patient of Rocky Mountain MS Center at the time of final study consent","Between 18-55 years of age at the time of final study consent","Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19","Has at minimum completed their first 600 mg dose of ocrelizumab","Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent","Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20","Can complete patient reported outcomes developed and validated as English written scales"],"whoShouldSkip":["Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion","Has previously not participated in the SaROD trial at the RMMSC site","Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC"],"whatHappens":"If you join, the listed intervention(s) are Ocrelizumab at home. The registry lists allocation as na. The goal is to assess the safety and effectiveness of home ocrelizumab infusion.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 110 people at Centennial. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.998Z"},{"nctId":"NCT04660435","title":"To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer","officialTitle":"Identification and Monitoring of Resistance to First-line Treatment With CDK 4/6 Inhibitors in Combination With Aromatase Inhibitors in Patients With Metastatic Luminal Breast Cancer Through Non-invasive Biomarkers","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fondazione Sandro Pitigliani","sponsorClass":"OTHER","summary":"This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice.\n\nBlood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.","conditions":["Metastatic Breast Cancer","ER Positive Breast Cancer","HER2-negative Breast Cancer"],"keywords":["CDK 4/6 inhibitors","Thymidine Kinase","Palbociclib","Abemaciclib","Ribociclib","circulating tumour DNA","gene expression signatures","aromatase inhibitors"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Thymidine kinase activity"}],"enrollment":150,"startDate":"2020-12-01","completionDate":"2029-12-01","sex":"FEMALE","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Women aged 18 years or older, with a diagnosis of metastatic breast cancer\n2. ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis\n3. The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)\n4. The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice\n5. The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable).\n\n   Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size.\n6. Hystologic material from one formalin-fixed, paraffin-embedded (FFPE) tumor block from a diagnostic core or excisional biopsy of a metastatic lesion, taken before study entry must be provided (patients with bone-only disease will be accepted into the trial without a biopsy of the metastatic site). Hystologic material from an additional biopsy (core or excisional) taken at time of disease progression on the study treatment must also be provided, if clinically feasible. When available, hystologic material from an FFPE tumor block from the primary breast cancer must also be submitted.\n7. The patient agrees to provide blood samples. at the trial specified time points\n\nExclusion Criteria:\n\n1. Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study.\n2. Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and/or adequately treated basal cell or squamous cell carcinoma of the skin","locations":[{"facility":"Hospital Santo Stefano","city":"Prato","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luca Malorni","phone":"+390574802523","email":"luca.malorni@uslcentro.toscana.it"},{"name":"Chiara Biagioni","phone":"+390574802526","email":"chiara.biagioni@uslcentro.toscana.it"}],"primaryOutcomes":["Progression free survival"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["prato-italy"],"enrichment":{"headline":"Not a traditional drug phase: Thymidine kinase activity for Metastatic Breast Cancer","inPlainEnglish":"This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor and a CDK4/6 inhibitor as per standard clinical practice. Blood and tissue samples will be collected for biomarker analysis, including thymidine kinase1 activity, gene expression signatures and circulating tumor DNA.","whoItsFor":["Women only","Women aged 18 years or older, with a diagnosis of metastatic breast cancer","ER-positive and HER2-negative disease as assessed locally either on primary tumor tissue or on a biopsy of a metastasis","The patient has not received any prior systemic therapy for metastatic breast cancer (may have received prior hormonal therapy or chemotherapy in the neo/adjuvant setting)","The patient is candidate to receive first-line therapy with an aromatase inhibitor (AI) and a CDK4/6 inhibitor per local clinical practice","The patient must have evaluable disease according to RECIST 1.1 (either measurable or non-measurable)","Note: Patients with bone-only disease will be allowed in a specific sub-cohort, which will comprise 10% of the total sample size","The patient agrees to provide blood samples. at the trial specified time points"],"whoShouldSkip":["Patients with metastatic disease isolated to the central nervous system (CNS) without metastatic involvement of any other site, unless surgical excision of CNS metastasis has been performed and the tumor tissue is available for the study","Previous or current non-breast malignancies within the last 5 years, with the exception of in situ carcinoma of the cervix and/or adequately treated basal cell or squamous cell carcinoma of the skin"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Prato. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.725Z"},{"nctId":"NCT04666727","title":"Role of Diet on the Microbiome of the Digestive System","officialTitle":"The Role of Diet and the Microbiome in Inducing Somatic Mutations in Colorectal Epithelial Cells and Its Predisposition to Carcinogenesis - A Pilot Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.","conditions":["Colorectal Carcinoma"],"keywords":[],"interventions":[],"enrollment":30,"startDate":"2020-09-29","completionDate":"2027-01-01","sex":"ALL","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* GROUP I: Patients presenting for a screening colonoscopy\n\n  * GROUP I: Age of 45 and above\n  * GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)\n  * GROUP I: Non smoker\n  * GROUP I: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples\n  * GROUP II: Patients presenting for a screening colonoscopy\n  * GROUP II: Age of 45 and above\n  * GROUP II: Omnivorous diet\n  * GROUP II: Non smoker\n  * GROUP II: Ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample\n\nExclusion Criteria:\n\n* • Current smokers (nicotine abuse only)\n\n  * Positive family history of colon cancer or colon cancer related syndromes\n  * Recent use of antibiotics in 1 month\n  * History of inflammatory bowel disease, and/or radiation enteritis or colitis\n  * Pregnant and breastfeeding women\n  * Women of child-bearing potential who have positive urine or serum pregnancy test\n  * Heavy drinker (defined as more than 14 drinks per week)\n  * Currently using anti-flatulence medications, probiotics and/or fiber supplements\n  * Major dietary restrictions and/or following a special diet\n  * Patient with positive fecal test/symptoms","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anusha Thomas, MD","phone":"713-563-9600","email":"asthomas1@mdanderson.org"}],"primaryOutcomes":["Dietary patterns","Microbiome composition","Somatic mutation burden"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Role of Diet on the Microbiome of the Digestive System","inPlainEnglish":"This study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. Researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.","whoItsFor":["Ages 45 Years to any","GROUP I: Patients presenting for a screening colonoscopy","GROUP I: Age of 45 and above","GROUP I: Strict vegetarian diet, determined by using diet history questionnaire 3.0 National Institutes of Health (NIH)","GROUP I: Non smoker","GROUP II: Patients presenting for a screening colonoscopy","GROUP II: Age of 45 and above","GROUP II: Omnivorous diet"],"whoShouldSkip":["Current smokers (nicotine abuse only)","Positive family history of colon cancer or colon cancer related syndromes","Recent use of antibiotics in 1 month","History of inflammatory bowel disease, and/or radiation enteritis or colitis","Pregnant and breastfeeding women","Women of child-bearing potential who have positive urine or serum pregnancy test","Heavy drinker (defined as more than 14 drinks per week)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Houston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.060Z"},{"nctId":"NCT04690972","title":"\"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases\".","officialTitle":"\"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases\".","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","sponsorClass":"OTHER_GOV","summary":"Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the efficacy of new therapeutic strategies.","conditions":["Chronic Liver Disease and Cirrhosis","Liver Cancer","Non-Alcoholic Fatty Liver Disease","Non-Alcoholic Steatohepatitis","Viral Hepatitis B","Viral Hepatitis C","Viral Hepatitis D"],"keywords":["Liver disease","Ex vivo models","Single cell","Biomarkers","Spheroïds"],"interventions":[{"type":"PROCEDURE","name":"Blood sample during surgery"},{"type":"PROCEDURE","name":"Taking an additional biopsy"},{"type":"DIAGNOSTIC_TEST","name":"Blood sample during diagnostic test"}],"enrollment":800,"startDate":"2021-01-14","completionDate":"2021-01-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients\n\n   * diagnosed with chronic liver disease (viral or not)\n   * diagnosed with at least one liver nodule for which a biopsy is planned as part of the care\n   * for hepatobiliary surgery planned as part of care\n   * for locoregional treatment for HCC is indicated\n2. Patients able to receive and understand information relating to the study and give their written informed consent\n3. Patients affiliated to the French social security system\n\nExclusion Criteria:\n\n1. Minor patients\n2. Patients under legal protection,\n3. Patients subject to legal protection or unable to express their consent,\n4. Patients in a situation of social fragility,\n5. Pregnant or breastfeeding woman,\n6. No signing of informed consent.","locations":[{"facility":"PU-PH, Directeur de l'UMR_S1110 Unité Inserm d'affiliation : UMR_S1110","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas BAUMERT, DR","phone":"03 68 85 37 03","email":"thomas.baumert@unistra.fr"}],"primaryOutcomes":["Surgery for a hepato-bilio-pancreatic issue"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["strasbourg-france"],"enrichment":{"headline":"Not a traditional drug phase: Blood sample during surgery for Chronic Liver Disease and Cirrhosis","inPlainEnglish":"Development of preclinical translational models for chronic liver tumors and diseases study, such as spheroids cultured in autologous medium and murine xenograft models to test the how well it works of new therapeutic strategies.","whoItsFor":["Ages 18 Years to any","diagnosed with chronic liver disease (viral or not)","diagnosed with at least one liver nodule for which a biopsy is planned as part of the care","for hepatobiliary surgery planned as part of care","for locoregional treatment for HCC is indicated","Patients affiliated to the French social security system"],"whoShouldSkip":["Patients under legal protection,","Patients subject to legal protection or unable to express their consent,","Patients in a situation of social fragility,","Pregnant or breastfeeding woman,"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 800 people at Strasbourg. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.157Z"},{"nctId":"NCT04693468","title":"Talazoparib and Palbociclib, Axitinib, or Crizotinib for the Treatment of Advanced or Metastatic Solid Tumors, TalaCom Trial","officialTitle":"Modular Phase 1B Hypothesis-Testing, Biomarker-Driven, Talazoparib Combination Trial (TalaCom)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book. PARP inhibitors, such as talazoparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Palbociclib, axitinib, and crizotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving talazoparib in combination with palbociclib, axitinib, or crizotinib may help control locally advanced or metastatic solid tumors.","conditions":["Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm","Recurrent Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"DRUG","name":"Axitinib"},{"type":"DRUG","name":"Crizotinib"},{"type":"DRUG","name":"Palbociclib Isethionate"},{"type":"DRUG","name":"Talazoparib Tosylate"}],"enrollment":111,"startDate":"2020-12-01","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification in at least one of the following:\n\n   * Defect in DNA Damage Response (DDR) genes specified below for each cohort or other related genes at the discretion of the principal investigator in consultation with the MD Anderson Cancer Center Institute for Personalized Cancer Therapy Precision Oncology Decision Support (PODS) group. See below for additional eligibility guidance for Arms A - C:\n   * Eligibility for Arm A (Talazoparib + Palbociclib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or\n     * MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation)\n   * Eligibility for Arm B (Talazoparib + Axitinib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or\n     * Participants with BRCA1/2 wild-type high-grade serous ovarian cancer, or\n     * Participants with metastatic castration-resistant prostate cancer without a specific and/or selected mutation\n   * Eligibility for Arm C (Talazoparib + Crizotinib):\n\n     * Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2,36 RAD51C/D, or other related genes at the discretion of the principal investigator, or\n     * Solid tumors with defects in MET, ALK or ROS1 (e.g. MET mutations or amplifications, high MET expression, ALK translocations, ROS1 translocations) NOTE: Participants who are eligible for more than one Arm will be assigned according to physician preference.\n2. Histological or cytological diagnosis of a solid tumor that is advanced/metastatic, intolerable to standard therapy, resistant to effective standard therapy, or for which no standard therapy is available.\n3. Availability of a fresh or recent tumor tissue sample from a diagnostic biopsy/surgery or a metastatic tumor biopsy; the sample must have been obtained within 12 months prior to study enrollment. When only bone disease is present, an archival tumor tissue sample obtained within 5 years prior to study enrollment may be accepted for non-prostate cancer patients and a fresh bone biopsy may be accepted for prostate cancer patients only.\n\n   NOTE: A fresh biopsy should be encouraged for all participants at time of enrollment even if a previous biopsy is available. Optional on-treatment and at-progression biopsies will be encouraged for all participants. With agreement of the PI, if the archived tissue is not available and/ or it is unsafe to obtain a fresh biopsy at screening, the participant is eligible.\n4. Have measurable disease at study enrollment as defined by RECIST v1.1 with at least 1 measurable lesion that has not previously been irradiated; or participants may have bone metastatic disease evaluable by Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration-resistant prostate cancer (mCRPC), or according to the tumor evaluation criteria best suited and accepted for the tumor type being evaluated).\n5. Age . 18 years old.\n6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 1.\n7. Adequate bone marrow function (without hematopoietic growth factor or transfusion support within 14 days prior to study enrollment), including:\n\n   * Absolute Neutrophil Count (ANC) ≥ 1,500/mm3 or ≥ 1.5 x 109/L\n   * Platelets ≥ 100,000/mm3 or ≥ 100 x 109/L\n   * Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L).\n8. Adequate renal function defined by an estimated creatinine clearance (CRCL) ≥ 60 mL/min OR normal creatinine as assessed by 24h urine assessment (not both) will be required during the dose-escalation phase.\n\n   * Calculate CRCL according to the Cockcroft-Gault formula as: CRCL = \\[(140-age) × weight)\\]/(72 x SCR)\\] × 0.85 (if female), where CRCL (creatinine clearance) is measured in mL/min, age is expressed in years, weight in kilograms (kg), and SCR (serum creatinine) in mg/dL 24h urine assessment:\n   * 24h urine assessment will be performed to assess whether creatinine is within normal limits\n   * In the event that 24h urine is used, then CRCL does not require to be calculated NOTE: Patients with moderate renal impairment (30 - 59 mL/min) will be considered during the dose expansion phase. A reduced starting dose for talazoparib will be considered in these patients. If the dose for dose expansion is 1 mg once daily, the dose will be reduced to 0.75 mg once daily. If the expanded dose is 0.75 mg once daily, the dose will be reduced to 0.5 mg once daily.\n9. Adequate liver function including:\n\n   * Total serum bilirubin ≤ 1.5 x the upper limit of normal range (ULN)\n   * Aspartate and Alanine aminotransferase (AST and ALT) ≤ 5 x ULN.\n10. Female participants of childbearing potential must have negative serum pregnancy or urine pregnancy test at screening. Female participants of non-childbearing potential must meet at least one of the following criteria:\n\n    * Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause and have a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state\n    * Have undergone a documented hysterectomy and/or bilateral oophorectomy\n    * Have medically confirmed ovarian failure All other female participants are considered to be of childbearing potential.\n11. Evidence of a personally signed and dated informed consent document, within 28 days prior to enrollment, indicating that the participant has been informed of all pertinent aspects of the study.\n12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n13. Able to swallow the study drug, have no known intolerance to study drugs or excipients, and comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior anti-cancer therapy within 2 weeks prior to study enrollment or prior radiation therapy within 2 weeks prior to study enrollment. Prior palliative radiotherapy to metastatic lesion(s) is permitted, provided it has been completed at least 2 days prior to study enrollment and no clinically significant toxicities are expected (e.g. mucositis, esophagitis).\n2. Major surgery within 4 weeks prior to study enrollment.\n3. Participants with known hypersensitivity to either talazoparib or the additional study drug to be received per treatment arm: palbociclib (Arm A), axitinib (Arm B), crizotinib (Arm C).\n4. Diagnosis of myelodysplastic syndrome (MDS).\n5. Known symptomatic brain metastases requiring steroids. Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study enrollment, have discontinued corticosteroid treatment for these metastases for at least 2 weeks, and are neurologically stable. Of note, participants who required a single dose of corticosteroids on days receiving radiation treatment do not require a 2-week washout.\n6. Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade \\> 1). However, alopecia and sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 adverse events not constituting a safety risk, based on the investigators judgement, are acceptable.\n7. Active infection requiring systemic therapy. Minor infections, e.g. periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.\n8. Participants with known uncontrolled HIV virus or Acquired immunodeficiency syndrome. Note: Patients with history of controlled HIV virus will be considered eligible for this trial.\n9. Participants with uncontrolled Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Note: Participants with controlled hepatitis B or hepatitis C will be considered eligible for this trial.\n10. Clinically significant cardiovascular disease, including any of the following:\n\n    * Myocardial infarction or symptomatic cardiac ischemia within 6 months before screening;\n    * Congestive heart failure New York Heart Association class III or IV;\n    * History of clinically significant ventricular arrhythmias (eg, sustained ventricular tachycardia, ventricular fibrillation, torsade de pointes) within 1 year before screening;\n    * History of Mobitz II second degree or third degree heart block unless a permanent pacemaker is in place;\n    * Hypotension as indicated by systolic blood pressure \\<86 mm Hg at screening;\n\n      * Bradycardia as indicated by a heart rate of \\<45 beats per minute on the screening electrocardiogram;\n      * For part B participants only: Uncontrolled hypertension as indicated by systolic blood pressure \\>140 mm Hg or diastolic blood pressure \\>90 mm Hg despite optimal treatment. Participants can only be on one antihypertensive and stable doses of antihypertensives at discretion of PI.\n11. Current use of potent P-gp inhibitors within 7 days prior to enrollment: amiodarone, carvedilol, clarithromycin, cobicistat, dronedarone, erythromycin, glecaprevir/pibrentasvir, indinavir, itraconazole, ketoconazole, lapatinib, lopinavir, propafenone, quinidine, ranolazine, ritonavir, saquinavir, sofosbuvir/velpatasvir/voxilaprevir, telaprevir, tipranavir, valspodar, and verapamil.\n\n    • NOTE: Participants who have recently been on enzalutamide require a 28 day washout period due to longer elimination half-life of this therapy.\n12. Participants treated within the last 7 days prior to enrollment with:\n\n    • Food or drugs that are known to be strong CYP (cytochrome P-450) 3A4 inhibitors (ie, amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, delavirdine, diltiazem, erythromycin, fosamprenavir, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, verapamil, voriconazole, and grapefruit or grapefruit juice).\n\n    Drugs that are known to be strong CYP3A4 inducers (ie, carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentin, and St. John's wort.\n13. Inability to swallow capsules, known malabsorption syndrome, or other conditions that may impair absorption of study drugs.\n14. Bisphosphonate or denosumab dosage that was not stable (i.e. not the same) for at least 2 weeks before study enrollment for patients receiving these therapies.\n15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the participant inappropriate for entry into this study.\n16. Medical, psychological, or social conditions that may interfere with the participant's participation in the study, or with the evaluation of the study results.\n17. Diagnosis of any other malignancy within 2 years prior to study enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast, bladder, or cervix, or low grade (Gleason ≤ 6) prostate cancer on surveillance without any plans for treatment intervention (e.g. surgery, radiation, or castration), or other early-stage low risk cancers.\n18. Pregnant female participants; breastfeeding female participants; fertile male participants; and female participants of childbearing potential who are unwilling or unable to use 2 methods of contraception for the duration of the study and for at least 7 months after the last dose of study drugs for female participants or 4 months after the last dose of study drugs for male participants, whichever is later for the individual patient. Male participants are prohibited from sperm donation while enrolled in this study and for 4 months after the last dose of the study drugs.\n\nHighly effective methods of contraception are those that alone or in combination, result in a failure rate of less than 1% per year when used consistently and correctly. These methods include:\n\n* Established use of oral, inserted, or injected or implanted hormonal methods of contraception are allowed provided the participant remains on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness.\n* Correctly placed copper containing intrauterine device (IUD).\n* Male condom or female condom used with spermicide (i.e. foam, gel, film, cream or suppository).\n* Male sterilization with appropriately confirmed absence of sperm in the post-vasectomy ejaculate.\n* Bilateral tubal ligation or bilateral oophorectomy.","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Timothy A. Yap","phone":"713-563-1784","email":"tyap@mdanderson.org"}],"primaryOutcomes":["Incidence of adverse events","Incidence of dose limiting toxicities"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["palbociclib"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: testing Axitinib for Advanced Malignant Solid Neoplasm","inPlainEnglish":"This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book.","whoItsFor":["Ages 18 Years to any","Pathogenic or likely pathogenic germline or somatic gene defect as determined by local assessment and classification in at least one of the following:","Eligibility for Arm A (Talazoparib + Palbociclib):","Solid tumors with defects in DDR genes such as: BRCA1/2, PALB2, RAD51C/D, or other related genes at the discretion of the principal investigator, or","MYC-aberrant solid tumors (e.g. overexpression, amplification, mutation)","Eligibility for Arm B (Talazoparib + Axitinib):","Participants with BRCA1/2 wild-type high-grade serous ovarian cancer, or","Participants with metastatic castration-resistant prostate cancer without a specific and/or selected mutation"],"whoShouldSkip":["Major surgery within 4 weeks prior to study enrollment","Participants with known hypersensitivity to either talazoparib or the additional study drug to be received per treatment arm: palbociclib (Arm A), axitinib (Arm B), crizotinib (Arm C)","Diagnosis of myelodysplastic syndrome (MDS)","Persisting toxicity related to prior therapy (NCI CTCAE v5.0 Grade \\> 1). However, alopecia and sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 side effects not constituting a safety risk, based on the investigators judgement, are acceptable","Active infection requiring systemic therapy. Minor infections, e.g. periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed","Participants with known uncontrolled HIV virus or Acquired immunodeficiency syndrome. Note: Patients with history of controlled HIV virus will be considered eligible for this trial","Participants with uncontrolled Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening. Note: Participants with controlled hepatitis B or hepatitis C will be considered eligible for this trial"],"whatHappens":"If you join, the listed intervention(s) are Axitinib, Crizotinib, or Palbociclib Isethionate. The registry lists allocation as randomized. This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 111 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.724Z"},{"nctId":"NCT04709900","title":"CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes","officialTitle":"DYnamic CT Stress Myocardial perfusioN, CT Fractional Flow Reserve and Coronary CT Angiography for Optimized treatMent Strategy In Patients With sTable Chest Pain syndromEs","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Copenhagen University Hospital, Rigshospitalet","sponsorClass":"OTHER","summary":"The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.","conditions":["Coronary Artery Disease","Chest Syndrome","Acute Myocardial Infarction","Heart Failure","Stroke","Cardiovascular Diseases"],"keywords":["Cardiac CT","Chest pain","Coronary artery disease"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"CT angiography, FFR-CT and stress CT myocardial perfusion"}],"enrollment":2000,"startDate":"2021-12-03","completionDate":"2026-12","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Chest pain in patients with clinically suspected or confirmed ischemic heart disease\n* Clinical indication for non-acute coronary evaluation\n* Status of coronary revascularization\n\n  1. With previous coronary revascularization - all patients\n  2. Without previous coronary revascularization\n\n     1. Age≥65 years - all patients with chest pain\n     2. Age\\>50 - \\<65 years - typical angina pectoris and at least one cardiovascular risk factor and/or previous myocardial infarction\n\n        * Typical angina requiring all 3 criteria present: a) constrictive discomfort in the front of the chest or in the neck, jaw, shoulder or arm, b) precipitated by physical exertion c) relieved by rest or nitrates within 5 min.\n        * Cardiovascular risk factors: hypertension, diabetes, hypercholesterolemia, current smoking, family history of ischemic heart disease, previous stroke, peripheral artery disease\n\nExclusion Criteria:\n\n* Persistent chest pain and signs of ongoing acute myocardial ischemia requiring acute coronary intervention\n* Hospitalization and discharge with the confirmed diagnosis acute coronary syndrome (STEMI or NSTEMI) within the last 6 months\n* Severe valvular heart disease as primary diagnosis and/or in potential need of percutaneous or surgical valve treatment\n* Known severe heart failure (LVEF less than 35%)\n* Language, cultural or mental factors preventing the patient from understanding the informed consent form\n* Known atrial fibrillation\n* Known renal impairment (estimated Glomerular Filtration Rate below \\<30 ml/min)\n* Known x-ray contrast allergy\n* Known intolerance to adenosine infusion","locations":[{"facility":"Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Klaus F Kofoed, MD","phone":"004535458569","email":"Klaus.kofoed@regionh.dk"}],"primaryOutcomes":["Major Adverse Cardiovascular Events"],"hasResults":false,"conditionSlugs":["stroke","heart-failure"],"drugSlugs":[],"locationSlugs":["copenhagen-denmark"],"enrichment":{"headline":"Not a traditional drug phase: CT angiography, FFR-CT and stress CT myocardial perfusion for Coronary Artery Disease","inPlainEnglish":"The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.","whoItsFor":["Chest pain in patients with clinically suspected or confirmed ischemic heart disease","Clinical indication for non-acute coronary evaluation","Status of coronary revascularization","With previous coronary revascularization - all patients","Without previous coronary revascularization","Age≥65 years - all patients with chest pain","Age\\>50 - \\<65 years - typical angina pectoris and at least one cardiovascular risk factor and/or previous myocardial infarction"],"whoShouldSkip":["Persistent chest pain and signs of ongoing acute myocardial ischemia requiring acute coronary intervention","Hospitalization and discharge with the confirmed diagnosis acute coronary syndrome (STEMI or NSTEMI) within the last 6 months","Severe valvular heart disease as primary diagnosis and/or in potential need of percutaneous or surgical valve treatment","Known severe heart failure (LVEF less than 35%)","Known atrial fibrillation","Known renal impairment (estimated Glomerular Filtration Rate below \\<30 ml/min)","Known x-ray contrast allergy"],"whatHappens":"If you join, the listed intervention(s) are CT angiography, FFR-CT and stress CT myocardial perfusion. The registry lists allocation as randomized. The purpose of the DYNAMITE trial (Dynamic CT stress myocardial perfusion, CT fractional flow reserve (FFR-CT) and coronary CT angiography for optimized treatment strategy in patients with chest pain syndromes) is to determine the ability of combined anatomical and functional cardiac CT imaging to improve morbidity and mortality in patients with suspected or known ischemic heart disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 2,000 people at Copenhagen. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.434Z"},{"nctId":"NCT04743141","title":"Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine","officialTitle":"Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \\< 18 years of age).","conditions":["Acute Treatment of Migraine"],"keywords":["Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent"],"interventions":[{"type":"DRUG","name":"Rimegepant (PF-07899801)"}],"enrollment":600,"startDate":"2021-04-28","completionDate":"2030-07-31","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. History of migraine (with or without aura) for ≥ 6 months before Screening.\n2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.\n3. 1 or more migraine days requiring treatment during the Observation Phase.\n4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.\n5. Ability to distinguish between migraine and other types of headaches.\n6. Weight \\> 15 kg. For EU countries only: Participants 12 to \\< 18 years of age must have a body weight of \\>25kg.\n7. Adequate venous access for blood sampling.\n8. Male and female participants 6 to \\< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).\n\nExclusion Criteria:\n\n1. History of cluster headache or hemiplegic migraine headache.\n2. Confounding and clinically significant pain syndrome.\n3. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).\n4. History of suicidal behavior or at risk of self-harm/harm to others.\n5. History of major psychiatric disorder.\n6. Current diagnosis or history of substance abuse\n7. Reported current use of or tested positive at Screening for drugs of abuse.","locations":[{"facility":"Perseverance Research Center, LLC","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians Research Group","city":"Tempe","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center, Inc.","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProScience Research Group","city":"Culver City","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Pain Research Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altman Clinical and Translational Research Institute, University of California San Diego","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adult & Child Neurology Medical Associates","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorialcare Miller Children's & Women's Hospital Long Beach","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research - North Hollywood","city":"North Hollywood","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Neurology Group","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy","city":"Sacramento","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of California, Davis Clinical and Translational Science Center Clinical Research Center","city":"Sacramento","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of California, Davis Midtown Clinic","city":"Sacramento","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research- Banning","city":"San Bernardino","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Research Management Group LLC","city":"Upland","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research","city":"Walnut Creek","state":"California","country":"United 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Sw. 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For EU countries only: Participants 12 to \\< 18 years of age must have a body weight of \\>25kg","Adequate venous access for blood sampling"],"whoShouldSkip":["History of cluster headache or hemiplegic migraine headache","Confounding and clinically significant pain syndrome","Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded)","History of suicidal behavior or at risk of self-harm/harm to others","History of major psychiatric disorder","Current diagnosis or history of substance abuse","Reported current use of or tested positive at Screening for drugs of abuse"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant (PF-07899801). The registry lists allocation as na. This study wants to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \\< 18 years of age).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 122 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.299Z"},{"nctId":"NCT04743791","title":"Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma","officialTitle":"A Randomized, Placebo-controlled, Parallel Group Study Designed to Assess the Change in Mucociliary Clearance After 12 Weeks of Treatment With Dupilumab in Patients With Moderate to Severe Asthma","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sally E. Wenzel MD","sponsorClass":"OTHER","summary":"Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.","conditions":["Asthma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"OTHER","name":"Placebo"}],"enrollment":30,"startDate":"2022-10-17","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \\<90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller\n* Age \\> 18\n* Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)\n* Reversibility \\>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening\n* FEV1/Forced Vital Capacity (FVC)\\<75%\n* Blood Eosinophils (EOS) \\>300 cells per mm3\n* Exhaled Nitric Oxide (FeNO) \\>25 parts per billion (ppb)\n* Asthma Control Test (ACT) score \\<20\n\nExclusion Criteria:\n\n* Pregnant, nursing, or unwilling to test for pregnancy\n* Current smoker or \\>10 pack year smoking history\n* Body Mass Index (BMI)\\>37\n* Respiratory infection in the last 30 days\n* Use of antibiotics or oral prednisone in the last 30 days\n* Current or previous use of dupilumab\n* Current or recent use of anti-IL-5 therapies\n* Any other criteria that place the subject at unnecessary risk\n* Diagnosis of other lung diseases including Chronic Obstructive Pulmonary Disease (COPD)\n* History of non-skin cell cancer in the last 5 years\n* Drug or alcohol addiction in the last 5 years\n* Any other uncontrolled disease","locations":[{"facility":"The University of Pittsburgh Asthma Institute at UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"John Moore","phone":"412-648-6726","email":"mooreja6@upmc.edu"}],"primaryOutcomes":["Change in mucociliary clearance (MCC) rate"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["dupilumab"],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 4: testing Dupilumab for Asthma","inPlainEnglish":"Single center, randomly assigned, dummy treatment (placebo)- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or dummy treatment (placebo).","whoItsFor":["Ages 18 Years to any","Moderate - Severe Th2 (Type 2) High asthma, as defined by Forced Expiratory Volume in one second (FEV1) \\<90% predicted, on medium to high dose inhaled corticosteroids (ICS) with or without a second controller","Inhaled steroid doses of 500micrograms (mcg) per day or more (Fluticasone equivalent)","Reversibility \\>/= 12% at screening or within the past 2 years, or a positive methacholine challenge test within the past 2 years, or a positive methacholine challenge during screening","FEV1/Forced Vital Capacity (FVC)\\<75%","Blood Eosinophils (EOS) \\>300 cells per mm3","Exhaled Nitric Oxide (FeNO) \\>25 parts per billion (ppb)","Asthma Control Test (ACT) score \\<20"],"whoShouldSkip":["Pregnant, nursing, or unwilling to test for pregnancy","Current smoker or \\>10 pack year smoking history","Body Mass Index (body-mass index (BMI))\\>37","Respiratory infection in the last 30 days","Use of antibiotics or oral prednisone in the last 30 days","Current or previous use of dupilumab","Current or recent use of anti-IL-5 therapies"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. Single center, randomly assigned, dummy treatment (placebo)- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or dummy treatment (placebo).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 30 people at Pittsburgh. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.712Z"},{"nctId":"NCT04748809","title":"Effect of Anti-inflammatory Diet in Rheumatoid Arthritis","officialTitle":"An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Rheumatoid Arthritis.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with rheumatoid arthritis, and the role of microbiome and circulating metabolites.","conditions":["Rheumatoid Arthritis"],"keywords":[],"interventions":[{"type":"OTHER","name":"Diet 1"},{"type":"OTHER","name":"Diet 2"}],"enrollment":124,"startDate":"2020-11-01","completionDate":"2027-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with low or moderate disease activity (defined as Clinical Disease Activity Index ≤ 22) and without changes in disease activity or therapy during the previous 3 months, who are interested in dietary intervention, and are able to provide consent and attend to follow up visits.\n\nExclusion Criteria:\n\n* Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study.\n* Food allergies\n* Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results","locations":[{"facility":"UCSD","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Monica Guma, MD, PhD","phone":"8588226523","email":"mguma@health.ucsd.edu"}],"primaryOutcomes":["Decrease of more than 5 points in Clinical Disease Activity Index"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Not a traditional drug phase: Diet 1 for Rheumatoid Arthritis","inPlainEnglish":"In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites.","whoItsFor":["Ages 18 Years to any"],"whoShouldSkip":["Pregnancy or lactating. Patients that will become pregnant during the study will be remove from the study","Subjects with significant other comorbidities and /or medication use which in physician's clinical judgment might difficult the interpretation of the results"],"whatHappens":"If you join, the listed intervention(s) are Diet 1, or Diet 2. The registry lists allocation as randomized. In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 124 people at La Jolla. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.953Z"},{"nctId":"NCT04765098","title":"Tamoxifen Versus Etoposide After First Recurrence in GBM Patients","officialTitle":"A Randomized Controlled Trial of Tamoxifen Versus Etoposide for Patients With First Recurrence of Glioblastoma Multiforme","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AHS Cancer Control Alberta","sponsorClass":"OTHER","summary":"The investigator propose a single-center randomized phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.","conditions":["Glioblastoma Multiforme"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tamoxifen"},{"type":"DRUG","name":"Etoposide"}],"enrollment":60,"startDate":"2022-01-28","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide.\n2. Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart.\n3. Not received radiotherapy within the three months before the diagnosis of progression.\n4. Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema.\n5. ECOG performance 0-2 (Appendix 2).\n6. Age from 18-65 years.\n7. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 72 hours prior to the first dose of study treatment. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes.\n8. Patients of childbearing / reproductive potential should use adequate birth control methods, as defined by the investigator, during the study treatment period and for a period of 60 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n9. Laboratory evaluation obtained within 7 days prior to randomization, with adequate function as defined below:\n\n   * ANC ≥ 1.5 x 109/L\n   * Platelets ≥ 100 x 109/L\n   * Serum creatinine ≤ 1.5 times ULN\n   * Total serum bilirubin ≤ 1.5 times ULN\n   * ALT \\< 3 times ULN\n   * AST \\< 3 times ULN\n   * Alkaline phosphatase \\< 3 times ULN\n10. Patient must understand and sign an informed consent prior to study registration.\n\nExclusion Criteria:\n\n1. History of another malignancy or a concurrent malignancy (exceptions include patients who have been disease-free for 3 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.\n2. Uncontrolled hypertension (systolic blood pressure \\>150 mm Hg or diastolic blood pressure \\>100 mm Hg).\n3. Any arterial or venous thrombosis up to 6 months before registration.\n4. Evidence of recent hemorrhage on brain MRI.\n5. Substantial cardiovascular disease: cerebral vascular accident/stroke (\\<6 months prior to enrollment), myocardial infarction (\\<6 months prior to enrollment), unstable angina, congestive heart failure (\\> New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.","locations":[{"facility":"Cross Cancer Institute","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jacob Easaw, MD, PhD, FRCPC","phone":"780-432-8290","email":"jay.easaw@ahs.ca"}],"primaryOutcomes":["3 month progression-free survival"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["edmonton-canada"],"enrichment":{"headline":"Phase 2: testing Tamoxifen for Glioblastoma Multiforme","inPlainEnglish":"The investigator propose a single-center randomly assigned phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.","whoItsFor":["Ages 18 Years to 65 Years","Histologically proven GBM with progression after previous first line chemoradiotherapy with temozolomide","Progression documented by MRI with at least one bi-dimensionally measurable target lesion with one diameter of at least 10 mm, visible on two or more axial slices 5 mm apart","Not received radiotherapy within the three months before the diagnosis of progression","Stable or decreasing dose of corticosteroids prior to randomization: corticosteroids (dexamethasone) should be given at the lowest dose needed to control symptoms arising from increased intracerebral edema","ECOG performance 0-2 (Appendix 2)","Age from 18-65 years","Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard"],"whoShouldSkip":["Uncontrolled hypertension (systolic blood pressure \\>150 mm Hg or diastolic blood pressure \\>100 mm Hg)","Any arterial or venous thrombosis up to 6 months before registration","Evidence of recent hemorrhage on brain MRI"],"whatHappens":"If you join, the listed intervention(s) are Tamoxifen, or Etoposide. The registry lists allocation as randomized. The investigator propose a single-center randomly assigned phase II controlled study designed to compare the management of first recurrence of GBM using etoposide versus tamoxifen.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.476Z"},{"nctId":"NCT04772079","title":"A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis","officialTitle":"A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Deucravacitinib (BMS-986165) in Pediatric Subjects With Moderate to Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this pediatric study is to evaluate the drug levels, efficacy and safety of Deucravacitinib in children and adolescent participants aged 4 to \\<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \\<18 years) and Cohort 2 (age 4 to \\<12 years), with two parts; for each cohort. Part A will evaluate the drug levels of BMS-986165 to enable selection of 2 dose levels to be studied in Part B. Part B will assess the efficacy and safety of two dose levels in children and adolescent participants with moderate to severe plaque psoriasis. The 5-year long-term extension (LTE) period will observe the long-term safety and tolerability of deucravacitinib in children and adolescent participants with psoriasis who have completed Parts A or B of the study.","conditions":["Plaque Psoriasis"],"keywords":["Adolescent Psoriasis","BMS-986165","Clinical trial","Deucravacitinib","Children Psoriasis","Pediatric Psoriasis","Plaque Psoriasis","Psoriasis"],"interventions":[{"type":"DRUG","name":"Deucravacitinib"},{"type":"OTHER","name":"Placebo matching deucravacitinib"}],"enrollment":153,"startDate":"2021-03-23","completionDate":"2029-01-01","sex":"ALL","minAge":"4 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Males and females aged 12 to \\<18 years for Cohort 1. Males and females aged 4 to \\<12 years for Cohort 2.\n* Plaque psoriasis for at least 6 months.\n* Moderate to severe disease.\n* Candidate for phototherapy or systemic therapy.\n* Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period.\n\nExclusion Criteria\n\n* Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \\< 18 years), Part A and Part B. Participants weighing \\< 18.0 kg at screening for Cohort 2 (age 4 to \\< 12 years), Part A and Part B.\n* Other forms of psoriasis.\n* History of recent infection.\n* Prior exposure to deucravacitinib (BMS-986165) or another active comparator.\n* Evidence of active TB for LTE period.\n* Other protocol-defined inclusion/exclusion criteria apply.","locations":[{"facility":"Instituto de Neumonologia Y Dermatologia","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psoriahue","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CONEXA Investigacion Clinica S.A.","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Metabólicas (CINME)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consultora Integral de Salud","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0020","city":"Darlinghurst","state":"New South Wales","country":"Australia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0002","city":"Westmead","state":"New South Wales","country":"Australia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Queensland Children's Hospital","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0003","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Monash Health","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0001","city":"Melbourne","state":"Victoria","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centro de Pesquisas da Clínica IBIS","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Moinhos de Vento","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0083","city":"Rio de Janeiro","state":"","country":"Brazil","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0067","city":"São Paulo","state":"","country":"Brazil","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0010","city":"Calgary","state":"Alberta","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Alberta Dermasurgery Centre","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0039","city":"Hamilton","state":"Ontario","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Lynderm Research Inc.","city":"Markham","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Calais","city":"Calais","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-dermatology","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nice - Hôpital l'Archet","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0021","city":"Paris","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Johannes Gutenberg Universität Mainz","city":"Mainz","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Carl Gustav Carus Dresden","city":"Dresden","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kath. Kinderkrankenhaus Wilhelmstift","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya City University Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka University Hospital","city":"Fukuoka, Jonan-Ku","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0040","city":"Isehara","state":"Kanagawa","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mie University Hospital","city":"Tsu","state":"Mie-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Medical University Hospital","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teikyo University Hospital","city":"tabashi City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nippon Life Hospital","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crea de Guadalajara","city":"Guadalajara","state":"Jalisco","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grupo Clínico CATEI S.C.","city":"Guadalajara","state":"Jalisco","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0052","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"COMPLETED","lat":null,"lon":null},{"facility":"Arké SMO S.A de C.V","city":"Veracruz","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0011","city":"Krakow","state":"","country":"Poland","status":"COMPLETED","lat":null,"lon":null},{"facility":"Dermoklinika Centrum Medyczne S.C. M. Kierstan, J. Narbutt, A. Lesiak","city":"Lodz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Państwowy Instytut Medyczny MSWiA-Klinika Dermatologii","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"WroMedica","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0080","city":"Bucharest","state":"Bucharest","country":"Romania","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0081","city":"Bucharest","state":"Bucharest","country":"Romania","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0088","city":"Bucharest","state":"Bucharest","country":"Romania","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"CCBR Clinical Research","city":"Bucharest","state":"Bucharest","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lotus-Med Tunari","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul clinic de urgenta pentru copii Sf. Maria","city":"Iași","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean Mures","city":"Târgu Mureş","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0048","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0047","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Catholic Univ. of Korea Seoul St. Mary's Hospital","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario de Alicante-Dermatology","city":"Alicante","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0026","city":"Barakaldo","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Déu-URC Dermatology","city":"Esplugues de Llobregat","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Gran Canaria Doctor Negrín-Dermatología","city":"Las Palmas de GC","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre-DERMATOLOGY","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz-UCICEC/DERMA","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0029","city":"London","state":"London, City of","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mounts Bay Medical","city":"Connor Downs","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0092","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Observed average concentration at steady state for deucravacitinib at Week 2","Maximum observed plasma concentration at steady state for deucravacitinib at Week 2","Trough observed plasma concentration for deucravacitinib at Week 2","Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16","Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16","Incidence of Adverse Events (AEs)","Incidence of serious adverse events (SAEs)","Monitoring of growth: Body weight","Monitoring of growth: Height","Monitoring of growth: Tanner staging (sexual maturation)"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["ciudad-autonoma-de-buenos-aires-argentina","buenos-aires-argentina","caba-argentina","c-rdoba-argentina","darlinghurst-australia","westmead-australia","brisbane-australia","woolloongabba-australia","clayton-australia","melbourne-australia","salvador-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","calgary-canada","edmonton-canada","hamilton-canada","markham-canada","toronto-canada","calais-france","dijon-france","nice-france","paris-france","m-nster-germany","mainz-germany","dresden-germany","berlin-germany","hamburg-germany","nagoya-japan","fukuoka-jonan-ku-japan","isehara-japan","tsu-japan","shinjuku-ku-japan","tabashi-city-japan","osaka-japan","guadalajara-mexico","mexico-city-mexico","veracruz-mexico","krakow-poland","lodz-poland","warsaw-poland","wroclaw-poland","bucharest-romania","ia-i-romania","t-rgu-mure-romania","seoul-south-korea","alicante-spain","barakaldo-spain","esplugues-de-llobregat-spain","las-palmas-de-gc-spain","madrid-spain","london-united-kingdom","connor-downs-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Deucravacitinib for Plaque Psoriasis","inPlainEnglish":"The purpose of this pediatric study is to measure the drug levels, how well it works and safety of Deucravacitinib in children and adolescent participants aged 4 to \\<18 years with moderate to severe plaque psoriasis. This study includes two cohorts; Cohort 1 (age 12 to \\<18 years) and Cohort 2 (age 4 to \\<12 years), with two parts; for each cohort.","whoItsFor":["Ages 4 Years to 18 Years","Males and females aged 12 to \\<18 years for Cohort 1. Males and females aged 4 to \\<12 years for Cohort 2","Plaque psoriasis for at least 6 months","Moderate to severe disease","Candidate for phototherapy or systemic therapy","Must have completed the Week 52 treatment period in Part A or B for long-term extension (LTE) period"],"whoShouldSkip":["Participants weighing ≤ 30.0 kg at screening for Cohort 1 (age 12 to \\< 18 years), Part A and Part B. Participants weighing \\< 18.0 kg at screening for Cohort 2 (age 4 to \\< 12 years), Part A and Part B","Other forms of psoriasis","History of recent infection","Prior exposure to deucravacitinib (BMS-986165) or another active comparator","Evidence of active TB for LTE period","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Deucravacitinib, or Placebo matching deucravacitinib. The registry lists allocation as randomized. The purpose of this pediatric study is to measure the drug levels, how well it works and safety of Deucravacitinib in children and adolescent participants aged 4 to \\<18 years with moderate to severe plaque psoriasis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 153 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.584Z"},{"nctId":"NCT04774536","title":"Transplantation of Clustered Regularly Interspaced Short Palindromic Repeats Modified Hematopoietic Progenitor Stem Cells (CRISPR_SCD001) in Patients With Severe Sickle Cell Disease","officialTitle":"Transplantation of CRISPRCas9 Corrected Hematopoietic Stem Cells (CRISPR_SCD001) in Patients With Severe Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Mark Walters, MD","sponsorClass":"OTHER","summary":"This is an open label, non-randomized, 2-center, phase 1/2 trial of a single infusion of sickle allele modified cluster of differentiation (CD34+) hematopoietic stem progenitor cells (HSPCs) in subjects with in subjects ≥12 years old to 35 years old severe Sickle Cell Disease (SCD). The study will evaluate the hematopoietic stem cell transplantation (HSCT) using CRISPR/Cas9 edited red blood cells (known as CRISPR\\_SCD001 Drug Product).","conditions":["Sickle Cell Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"CRISPR_SCD001"}],"enrollment":9,"startDate":"2025-08-22","completionDate":"2030-03-01","sex":"ALL","minAge":"12 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female 12.00 - 34.99 years of age (at time of consent) who have one or more of the following:\n\n   1. History of two or more episodes of acute chest syndrome (ACS) in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. asthma therapy and/or hydroxyurea); ACS is defined as a new radiodensity on chest imaging accompanied by fever and/or respiratory symptoms, treated in the hospital with supplemental oxygen at a minimum.\n   2. History of at least 4 severe vaso-occlusive pain events in the 2-year period preceding enrollment despite the institution of supportive care measures (i.e. a pain management plan and/or treatment with hydroxyurea); painful episodes related to or any sickle-related acute event are acceptable; a severe painful vaso-occlusive event is defined as receiving analgesic treatment (opioid or other analgesic via parenteral (PN) route) for longer than 24 -hours in a hospital or emergency room (ER) observation unit visit or at least 2 visits in a day unit or ER over 72 hours with both visits requiring parenteral analgesics.\n   3. 2 or more episodes of splenic sequestration, defined as an acute decrease in hemoglobin by at least 2 g/dL accompanied by splenomegaly in the 2 years before enrollment.\n   4. Recurrent priapism (episodes lasting at least 4 hours at least twice in the last 12 months or 3 times in the last 24 months before enrollment) recalcitrant to medical treatment\n   5. Any episode of hepatic sequestration defined as right upper quadrant pain, hepatomegaly, and rapidly decreasing hemoglobin level with hepatic dysfunction within the 2 years before enrollment.\n   6. Leg ulcer recalcitrant to treatment within 2 years prior to enrollment.\n2. Participants must have adequate physical function as measured by all of the following:\n\n   1. Karnofsky performance score ≥60.\n   2. Cardiac function: Left ventricular ejection fraction (LVEF) \\>40%; or LV shortening fraction \\> 26% by cardiac echocardiogram or by (multiple-gated acquisition) MUGA scan.\n   3. Pulmonary function: Pulse oximetry with a baseline O2 saturation of ≥85% and diffusion capacity of lung for carbon monoxide(DLCO) \\> 40% (corrected for hemoglobin).\n   4. Renal function: Serum creatinine ≤ 1.5 x upper limit of normal for age and estimated or measured creatinine clearance ≥ 70 mL/min/1.73 m2.\n   5. Hepatic function:\n\n   i. Serum conjugated (direct) bilirubin \\< 2x upper limit of normal for age as per local laboratory. Participants with hyperbilirubinemia as the result of hyperhemolysis, or a severe drop in hemoglobin post blood transfusion, are not excluded.\n\n   ii. Alanine aminotransferase (ALT) and aspartate aminotransferase (AS \\< 5 times upper limit of normal as per local laboratory.\n\n   Participants who have liver iron concentration (LIC) on liver MRI of ≥12 mg Fe/g liver dry weight should also have MR elastography (MRE) or Ultrasound elastography obtained. If severe fibrosis is present, no liver biopsy will be performed and participant is excluded. Children with LIC \\>12 and negative elastography imaging are eligible if a clinically indicated liver biopsy shows no significant fibrosis.\n3. Baseline prothrombin time or partial thromboplastin time \\<1.5 ULN except if receiving a prophylactic anticoagulant which causes an elevated prothrombin or partial thromboplastin time.\n4. Written informed consent or assent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. Participants with uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).\n2. Participants with evidence of HIV infection or seropositivity for HIV or active hepatitis B or C.\n3. Participants who have received a Hematopoietic Cell Transplant (HCT)\n4. Participants who have received a solid organ transplant.\n5. Participants who have participated in another clinical trial in which the participant received an investigational or off-label use of a drug or device within 3 months prior to enrollment.\n6. Females who are pregnant or breast feeding.\n7. Females of child bearing potential (to include all female participants \\> 10 years of age, unless postmenopausal for a minimum of 1 year before the time of consent or surgically sterilized) who do not agree to practice two (2) effective methods of contraception at the same time, or who do not agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject, from the time of signing of informed consent through 12 months post-stem cell infusion.\n8. Males (even if surgically sterilized) who do not agree to practice effective barrier contraception, or who do not agree to practice true abstinence from the time of signing informed consent through 12 months post-stem cell infusion.\n9. Participants who have had a stroke OR who are receiving red blood cell (RBC) transfusions to prevent primary stroke or silent cerebral infarction.\n10. Patients who have a suitable human leukocyte antigen identical (HLA-ID) sibling donor willing and able to donate bone marrow.\n11. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n12. Any non-homozygous sickle hemoglobin (HbSS) genotype of SCD\n13. Either or both of the following findings on screening bone marrow aspirate/biopsy:\n\n    1. diagnosis of myelodysplastic syndrome (MDS) based on morphology and/or cytogenetics (based on WHO definitions) OR\n    2. any evidence of a pathogenic clonal variant in any candidate gene detected by a standard, licensed next-generation sequencing clinical assay for gene mutations associated with hematological malignancies.\n14. The participant has an identified pathogenic mutation associated with myeloid malignancy as identified by RHP or a variant of unknown significance (VUS) judged to be pathogenic for myeloid malignancy as determined by one or more members of the adjudication panel.","locations":[{"facility":"University of California, Davis","city":"Davis","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Benioff Children&#39;s Hospital","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mark Walters, MD","phone":"(510) 428-3374","email":"Mark.Walters@ucsf.edu"},{"name":"Marci Moriarty, RN, BSN","phone":"510-428-3885","email":"Marci.Moriarty@ucsf.edu"}],"primaryOutcomes":["Incidence of adverse events and grade 3 or higher serious adverse events, using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE)"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["davis-california","los-angeles-california","oakland-california"],"enrichment":{"headline":"Phase 1 / Phase 2: testing CRISPR_SCD001 for Sickle Cell Disease","inPlainEnglish":"This is an open label, non-randomly assigned, 2-center, phase 1/2 trial of a single infusion of sickle allele modified cluster of differentiation (CD34+) hematopoietic stem progenitor cells (HSPCs) in subjects with in subjects ≥12 years old to 35 years old severe Sickle Cell Disease (SCD). The study will measure the hematopoietic stem cell transplantation (HSCT) using CRISPR/Cas9 edited red blood cells (known as CRISPR\\_SCD001 Drug Product).","whoItsFor":["Ages 12 Years to 35 Years","Male or female 12.00 - 34.99 years of age (at time of consent) who have one or more of the following:","2 or more episodes of splenic sequestration, defined as an acute decrease in hemoglobin by at least 2 g/dL accompanied by splenomegaly in the 2 years before enrollment","Recurrent priapism (episodes lasting at least 4 hours at least twice in the last 12 months or 3 times in the last 24 months before enrollment) recalcitrant to medical treatment","Any episode of hepatic sequestration defined as right upper quadrant pain, hepatomegaly, and rapidly decreasing hemoglobin level with hepatic dysfunction within the 2 years before enrollment","Leg ulcer recalcitrant to treatment within 2 years prior to enrollment","Participants must have adequate physical function as measured by all of the following:","Karnofsky performance score ≥60"],"whoShouldSkip":["Participants with uncontrolled bacterial, viral or fungal infection in the 6 weeks before enrollment (currently taking medication with evidence of progression of clinical symptoms or radiologic findings)","Participants with evidence of HIV infection or seropositivity for HIV or active hepatitis B or C","Participants who have received a Hematopoietic Cell Transplant (HCT)","Participants who have received a solid organ transplant","Participants who have participated in another clinical trial in which the participant received an investigational or off-label use of a drug or device within 3 months prior to enrollment","Females who are pregnant or breast feeding","Participants who have had a stroke OR who are receiving red blood cell (RBC) transfusions to prevent primary stroke or silent cerebral infarction"],"whatHappens":"If you join, the listed intervention(s) are CRISPR_SCD001. The registry lists allocation as na. This is an open label, non-randomly assigned, 2-center, phase 1/2 trial of a single infusion of sickle allele modified cluster of differentiation (CD34+) hematopoietic stem progenitor cells (HSPCs) in subjects with in subjects ≥12 years old to 35 years old severe Sickle Cell Disease (SCD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 9 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.842Z"},{"nctId":"NCT04780568","title":"Osimertinib and Tegavivint as First-Line Therapy for the Treatment of Metastatic EGFR-Mutant Non-small Cell Lung Cancer","officialTitle":"A Phase Ib Study of AZD9291 (Osimertinib) and BC2059 (Tegavivint) as First-Line Therapy in Patients With Metastatic EGFR-Mutant Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Ohio State University Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","conditions":["Metastatic Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8","Stage IVA Lung Cancer AJCC v8","Stage IVB Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"DRUG","name":"Osimertinib"},{"type":"DRUG","name":"Tegavivint"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"FDG-Positron Emission Tomography"},{"type":"PROCEDURE","name":"Biospecimen Collection"}],"enrollment":25,"startDate":"2022-01-18","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>= 18 years. Children are excluded from this study because neither dosing nor safety data are currently available for AZD9291 or BC2059 in patients \\< 18 years of age\n* Pathology-confirmed metastatic NSCLC\n* A common activating mutation must be present in the EGFR gene, i.e., exon 19 deletion or L858R. The presence of uncommon EGFR mutations, e.g., G719X, S768I, or L861Q are also permitted if they co-occur with a common activating mutation. Mutation status must be determined using a tumor biopsy by local Clinical Laboratory Improvement Act (CLIA)-certified assessment. Mutations identified by blood-based testing can be provided, but must be verified by tumor biopsy\n* The presence of a concurrent T790M mutation, while uncommon in patients who are naïve to treatment with EGFR TKIs, is also permitted\n* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)\n* The patient must be able to swallow pills\n* Life expectancy \\> 3 months\n* Leukocytes \\>= 3,000/mcL\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 100,000/mcL\n* Hemoglobin \\>= 90 g/L\n* Total bilirubin =\\< 1.5 x institutional upper limit normal (ULN) and up to 3 mg/dL for patients with Gilbert's\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase ALT (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN and =\\< 5 x institutional ULN for patients with liver metastases\n* Creatinine within 1.5 x ULN OR glomerular filtration rate (GFR) \\>= 50 mL/min/1.73 m\\^2 (measured or calculated by Cockcroft and Gault equation) -confirmation of creatinine clearance is only required for patients with creatinine levels above institutional upper limit of normal\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, it must be treated and have an undetectable viral load\n* Patients with treated brain metastases are asymptomatic and not requiring ongoing treatment\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS)-specific treatment is not required and is unlikely to be required during the first cycle of therapy. Clinical stability on a stable dose of decadron is permitted\n* Patients with a prior or concurrent malignancy whose natural history or treatment will not interfere with the safety or efficacy assessment of the investigational drugs are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients must be class 2B or better\n* Ability to understand and sign a written informed consent document\n\nExclusion Criteria:\n\n* Prior treatment with an EGFR TKI in any setting\n* Patients who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease\n* Patients who are receiving any other investigational agent or immunotherapy within five half-lives of the compound or 3 months, whichever is greater\n* Patients with an uncontrolled intercurrent illness\n* Patients with psychiatric illness/social situations that would limit compliance with study requirements\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as BC2059 or AZD9291. Patients with hypersensitivity to any of the inactive excipients should also be excluded\n* Currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4 (wash-out periods vary. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4\n* Pregnant women are excluded from this study because BC2059 has the potential for teratogenic or abortifacient effects. There is also an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with AZD9291 or BC2059. Breastfeeding patients will be excluded\n* Patients with a significant history of cardiovascular disease (e.g., myocardial infarction \\[MI\\], thrombotic or thromboembolic event in the last 6 months)\n* Any of the following cardiac criteria:\n\n  * Mean resting corrected QT interval (corrected QT \\[QTc\\] using Fredericia's formula \\[QTcF\\]) \\> 470 msec. RR is the time from the interval of 1 QRS complex to the next measured in seconds and is commonly calculated as (60/HR)\n  * Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block)\n  * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as decompensated heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives, or any concomitant medication known to prolong the QT interval\n  * Left ventricular ejection fraction (LVEF) \\< lower limit of normal (LLN) as assessed by either multigated acquisition (MUGA) scan or echocardiogram (ECHO)\n* Patients with active malignancies other than NSCLC or patients with prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers, ductal carcinoma in-situ (DCIS), or indolent cancer currently on observation (i.e. chronic lymphocytic leukemia \\[CLL\\] or low-risk prostate cancer)\n* Any evidence of severe or uncontrolled systemic disease, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol, or active infection with human immunodeficiency virus (HIV). Screening for chronic conditions is not required\n* Patients who are at risk for impaired absorption of oral medication including, but not limited to, refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD9291\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, or requirements\n* Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site)","locations":[{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"The Ohio State University Comprehensive Cancer Center","phone":"800-293-5066","email":"OSUCCCClinicaltrials@osumc.edu"}],"primaryOutcomes":["Maximum tolerated dose"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Phase 1: testing Osimertinib for Metastatic Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Age \\>= 18 years. Children are excluded from this study because neither dosing nor safety data are currently available for AZD9291 or BC2059 in patients \\< 18 years of age","Pathology-confirmed metastatic NSCLC","The presence of a concurrent T790M mutation, while uncommon in patients who are naïve to treatment with EGFR TKIs, is also permitted","Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria","Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (Karnofsky \\>= 60%)","The patient must be able to swallow pills","Life expectancy \\> 3 months"],"whoShouldSkip":["Prior treatment with an EGFR TKI in any setting","Patients who have not recovered from side effects (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), with the exception of alopecia","Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease","Patients who are receiving any other investigational agent or immunotherapy within five half-lives of the compound or 3 months, whichever is greater","Patients with an uncontrolled intercurrent illness","Patients with psychiatric illness/social situations that would limit compliance with study requirements","History of allergic reactions attributed to compounds of similar chemical or biologic composition as BC2059 or AZD9291. Patients with hypersensitivity to any of the inactive excipients should also be excluded"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib, Tegavivint, or Echocardiography Test. The registry lists allocation as na. This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 25 people at Columbus. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.688Z"},{"nctId":"NCT04781140","title":"Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD","officialTitle":"A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Supernus Pharmaceuticals, Inc.","sponsorClass":"INDUSTRY","summary":"This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.","conditions":["Attention-Deficit/Hyperactivity Disorder"],"keywords":["ADHD"],"interventions":[{"type":"DRUG","name":"100mg SPN-812"},{"type":"DRUG","name":"Placebo"}],"enrollment":286,"startDate":"2024-03-19","completionDate":"2028-01","sex":"ALL","minAge":"48 Months","maxAge":"69 Months","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.\n2. Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.\n3. Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).\n4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).\n5. Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).\n6. Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.\n7. Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.\n8. Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \\[Screening\\] and continues with a similar duration/frequency throughout their study).\n9. Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.\n10. Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.\n11. Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).\n12. Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).\n\nExclusion Criteria:\n\n1. Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.\n2. Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.\n3. History of Bipolar Disorder diagnosed in a first degree relative.\n4. Has global development delay or intellectual disability by medical history.\n5. Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.\n6. Has body mass index \\> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).\n7. Has a mean resting systolic and diastolic blood pressure\\* that are both \\>95th percentile for age sex, and height and has a mean resting pulse rate\\* that is \\>95th percentile for age and sex (males: \\>117 bpm; females: \\>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \\* Note: The mean of three measurements while seated.\n8. Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).\n9. Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.\n10. Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.\n11. Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.\n12. Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).\n13. Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).\n14. Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.\n15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.\n16. Has suicidal ideation (\"Yes\" indicated on C-SSRS question 4 or 5) or suicidal behavior (\"Yes\" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide (\"Yes\" indicated on C-SSRS for lifetime).","locations":[{"facility":"The Center for Clinical Trials, Inc.","city":"Saraland","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Preferred Research Partners-NWA, LLC","city":"Fayetteville","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Preferred Research Partners, Inc.","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center (ARC), Inc.","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino]","city":"Encino","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Institute of Clinical Research (PICR)","city":"Garden Grove","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Sun Valley Research Center","city":"Imperial","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach]","city":"Newport Beach","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"IMMUNOe Research Centers","city":"Centennial","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vertex Clinical Research, LLC","city":"Clermont","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Luna Research Center","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarkis Clinical Trials","city":"Gainesville","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - Lakeland CRU","city":"Lakeland","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Avantis Clinical Research LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Research Group of Central Florida","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"APG Research LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"D&H Tamarac Research Center","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Research Network, LLC.","city":"Virginia Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pediatric Neurology and Epilepsy Specialists","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Discovery Research LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExcel iResearch, LLC","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel iResearch, LLC.","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qualmedica Research, LLC.","city":"Evansville","state":"Indiana","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Kentucky Pediatric/Adult Research","city":"Bardstown","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qualmedica Research, LLC.","city":"Owensboro","state":"Kentucky","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"DelRicht Research (Touro Medical Center)","city":"New Orleans","state":"Louisiana","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"DelRicht Research","city":"Prairieville","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kennedy Krieger Institute","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurobehavioral Medicine Group","city":"Bloomfield Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precise Research Centers","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Southern Nevada, LLC.","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hassman Research Institute","city":"Berlin","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Med Clinical Research","city":"Irvington","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jersey Shore University Medical Center","city":"Neptune City","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital and Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CincyScience","city":"West Chester","state":"Ohio","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Cyn3rgy Research","city":"Gresham","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Health Medical Group - Psychiatry and Behavioral Health","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Coastal Carolina Research Center","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Coastal Pediatric Research","city":"Summerville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Clinical Trials, LLC.","city":"Bellaire","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Javara","city":"Dallas","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"AIM Trials, LLC","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Family Psych of The Woodlands","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Partners, LLC","city":"Petersburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University, Virginia Treatment Center for Children","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Olivia Elbaum","phone":"301-838-2500","email":"clinicaltrials@supernus.com"}],"primaryOutcomes":["Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["saraland-alabama","fayetteville-arkansas","little-rock-arkansas","anaheim-california","encino-california","garden-grove-california","imperial-california","long-beach-california","newport-beach-california","centennial-colorado","clermont-florida","coral-gables-florida","gainesville-florida","jacksonville-florida","lakeland-florida","miami-florida","orange-city-florida","orlando-florida","tamarac-florida","virginia-gardens-florida","winter-park-florida","atlanta-georgia","decatur-georgia","savannah-georgia","evansville-indiana","bardstown-kentucky","owensboro-kentucky","new-orleans-louisiana","prairieville-louisiana","baltimore-maryland","boston-massachusetts","bloomfield-hills-michigan","flowood-mississippi","las-vegas-nevada","berlin-new-jersey","irvington-new-jersey","neptune-city-new-jersey","new-york-new-york","durham-north-carolina","cincinnati-ohio","west-chester-ohio","gresham-oregon","hershey-pennsylvania","north-charleston-south-carolina","summerville-south-carolina","memphis-tennessee","bellaire-texas","dallas-texas","plano-texas","the-woodlands-texas","petersburg-virginia","richmond-virginia"],"enrichment":{"headline":"Phase 4: testing 100mg SPN-812 for Attention-Deficit/Hyperactivity Disorder","inPlainEnglish":"This study will measure the how well it works and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.","whoItsFor":["Ages 48 Months to 69 Months","Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy","Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL)","Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline)","Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline)","Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment","Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home","Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/"],"whoShouldSkip":[", and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate","Has no current condition in the opinion of the Investigator that could confound how well it works assessments, safety assessments or increase participant risk","Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening)","Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline)"],"whatHappens":"If you join, the listed intervention(s) are 100mg SPN-812, or Placebo. The registry lists allocation as randomized. This study will measure the how well it works and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 286 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.657Z"},{"nctId":"NCT04802759","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","officialTitle":"A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.\n\nCohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting.\n\nCohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib).\n\nCohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.","conditions":["Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Giredestrant"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Ipatasertib"},{"type":"DRUG","name":"Inavolisib"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Everolimus"},{"type":"DRUG","name":"Samuraciclib"},{"type":"DRUG","name":"PH FDC SC"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Atezolizumab"}],"enrollment":316,"startDate":"2021-06-22","completionDate":"2029-05-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion Criteria for Cohort 1 (Stage 1 \\[and Stage 2, only where indicated\\]):\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Documented estrogen receptor-positive (ER+) tumor\n* Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines\n* Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer\n* Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)\n* Postmenopausal status for women\n* Life expectancy ≥3 months\n* Availability of a representative tumor specimen that is suitable for biomarker evaluation via central testing\n* Prior fulvestrant therapy is allowed\n* Stages 1 and 2: Measurable disease (at least one target lesion) according to RECIST v1.1\n* Stages 1 and 2: Adequate hematologic and end-organ function\n* Stages 1 and 2: Stable anticoagulant regimen for patients receiving therapeutic anticoagulation\n\nInclusion Criteria for Cohort 2 (Stage 1 \\[and Stage 2, only where indicated\\]):\n\n* ECOG Performance Status of 0 or 1\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection\n* ER+, HER2-positive breast cancer\n* Postmenopausal status for women\n* Life expectancy ≥3 months\n* Willingness to have a representative tumor specimen that is suitable for biomarker evaluation via central testing submitted, if available\n* Prior endocrine therapy in the advanced setting allowed, including fulvestrant if given more than 28 days prior to randomization, but excluding other selective estrogen receptor degraders (SERDs)\n* Stages 1 and 2: Measurable disease (at least one target lesion) according to RECIST v1.1\n* Stages 1 and 2: Baseline left ventricular ejection fraction (LVEF) ≥50% as measured by ECHO or MUGA scans\n* Stages 1 and 2: Adequate hematologic and end-organ function\n* Stages 1 and 2: Stable anticoagulant regimen for patients receiving therapeutic anticoagulation\n\nInclusion Criteria for Cohorts 1 and 2 (Stage 2):\n\n* Ability to initiate Stage 2 treatment within 3 months after experiencing unacceptable toxicity, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator, provided that a Stage 2 slot is available and patient meets eligibility criteria for Stage 2\n* Availability of a tumor specimen from a biopsy performed upon discontinuation of Stage 1 because of unacceptable toxicity to drugs, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator\n\nInclusion Criteria for Cohort 3:\n\n* Measurable disease (at least one target lesion) according to RECIST v1.1\n* ECOG Performance Status of 0 or 1\n* Documented ER+ tumor\n* Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines\n* Histologically or cytologically confirmed and documented adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Patients must have progressed during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen. If a CDK4/6i was included as part of neoadjuvant or adjuvant therapy, progression event must be \\>12 months since completion of CDK4/6i portion of neoadjuvant or adjuvant therapy.\n* Postmenopausal status for women (including women on or starting luteinizing hormone-releasing hormone \\[LHRH\\] agonist for ovarian suppression prior to randomization)\n* Life expectancy ≥6 months\n* Adequate hematologic and end-organ function\n* Evidence of an eligible PIK3CA mutation based on pre-existing test results (i.e., previously obtained as part of clinical practice) from blood or tumor tissue. If pre-existing test results are not available, submission of a freshly collected pretreatment blood sample to determine PIK3CA mutation status at a central testing site with the FoundationOne Liquid® CDx assay is required.\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria for all Treatment Arms in Stage 1, Cohorts 1 and 2 (unless only applicable to one cohort, as indicated):\n\n* Prior treatment with any of the protocol-specified study treatments\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Systemic treatment for breast cancer within 2 weeks of Cycle 1, Day 1 or 5 half-lives of the drug prior to Cycle 1, Day 1\n* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 or better, with the exception of alopecia of any grade and Grade ≤2 peripheral neuropathy\n* Eligible only for the control arm\n* Prior allogeneic stem cell or solid organ transplantation\n* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study\n* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* History of leptomeningeal disease\n* Active tuberculosis\n* Severe infection within 4 weeks prior to initiation of study treatment\n* Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan\n* Active cardiac disease or history of cardiac dysfunction\n* Positive HIV test at screening or at any time prior to screening\n* Active Hepatitis B or Hepatitis C virus infection\n* Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery, including gastric resection, potentially affecting enteral absorption\n* Known allergy or hypersensitivity to any of the study drugs or any of their excipients\n* Cohort 1 only: Known HER2-positive breast cancer\n* Cohort 1 only: Concurrent hormone replacement therapy\n* Cohort 1 only: Prior treatment with cytotoxic chemotherapy for metastatic breast cancer (with the exception of single agent capecitabine, which will count as a single line of therapy)\n* Cohort 2 only: Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy\n* Cohort 2 only: Current chronic daily treatment (continuous for \\>3 months) with corticosteroids (dose of 10 mg/day methylprednisolone equivalent), excluding inhaled steroids\n\nAdditional Exclusion Criteria for Giredestrant + Abemaciclib Arm and Giredestrant + Abemaciclib + Atezolizumab Arm (Cohort 1, Stage 1):\n\n* Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy\n* History of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea\n* History of syncope of cardiovascular etiology, ventricular arrhythmia, or sudden cardiac arrest\n\nAdditional Exclusion Criteria for Giredestrant + Ipatasertib Arm (Cohort 1, Stage 1):\n\n* Prior treatment with an Akt inhibitor\n* Inability to swallow medication or malabsorption condition that would alter the absorption of orally administered medications\n* Grade ≥2 uncontrolled or untreated hypercholesterolemia or hypertriglyceremia\n* History of Type 1 or Type 2 diabetes mellitus requiring insulin\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion\n\nAdditional Exclusion Criteria for the Giredestrant + Inavolisib and Giredestrant + Inavolisib (ESR1m enriched) Arms (Cohort 1, Stage 1):\n\n* Prior treatment with any PI3K, Akt, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K/Akt/mTOR pathway\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Fasting glucose ≥126 mg/dL or ≥7.0 mmol/L and HbA1c ≥5.7% (or HbA1c ≥6.4% for the ESR1m enriched Arm only)\n* Any concurrent ocular or intraocular condition, excluding baseline cataracts, that, in the opinion of the investigator, would require medical or surgical intervention during the study period to prevent or treat vision loss\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease, including pneumonitis\n* Inability to confirm biomarker eligibility based on valid results from either central testing of blood or local testing of blood or tumor tissue that documents one of the protocol-defined PIK3CA mutations\n* ESR1m enriched Arm only: Inability to determine ESR1 mutation status based on valid results from either central testing of blood or from pre-existing test results (from blood or tumor tissue) that confirm the presence of an ESR1 mutation. While patients who have tumors without detectable ESR1 mutation may be enrolled in this arm, a pre-existing test with no detectable ESR1m result is not acceptable for enrollment, and the participant in this case must submit a sample for central testing.\n\nAdditional Exclusion Criteria for Giredestrant + Ribociclib Arm (Cohort 1, Stage 1):\n\n* Currently receiving or has received systemic corticosteroids ≤2 weeks prior to starting trial treatment\n* Impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments\n\nAdditional Exclusion Criteria for Giredestrant + Samuraciclib Arm (Cohort 1, Stage 1):\n\n* Prior treatment with mTOR inhibitor\n* Receipt of systemic corticosteroids (at a dose \\>10 mg prednisone/day or equivalent) within 14 days before the first dose of samuraciclib\n* Active bleeding diatheses\n* History of hemolytic anemia or marrow aplasia\n* Receipt of a live-virus vaccination within 28 days or less of planned treatment start\n\nAdditional Exclusion Criteria for Giredestrant + Atezolizumab-Containing Arms (Cohort 1, Stage 1):\n\n* Active or history of autoimmune disease or immune deficiency\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab\n* Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment\n* Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies\n* Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies\n* Pregnant or breastfeeding, or intending to become pregnant during study treatment or within 5 months for atezolizumab\n\nAdditional Exclusion Criteria for Giredestrant + PH FDC SC + Abemaciclib Arm (Cohort 2, Stage 1):\n\n* Interstitial lung disease or severe dyspnea\n* History of major surgical resection involving the stomach or small bowel, preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, or a condition that may significantly alter the absorption of the oral trial treatments\n* History of syncope of cardiovascular etiology, ventricular arrhythmia, or sudden cardiac arrest\n\nAdditional Exclusion Criteria for Giredestrant + PH FDC SC + Palbociclib Arm (Cohort 2, Stage 1):\n\n* History of major surgical resection involving the stomach or small bowel, preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea, or a condition that may significantly alter the absorption of the oral trial treatments\n* Interstitial lung disease or severe dyspnea\n\nExclusion Criteria for Cohort 3:\n\n* Known HER2-positive breast cancer\n* Prior treatment with any SERD (e.g., fulvestrant, novel oral), proteolysis targeting chimera, complete ER antagonist (CERAN), or novel SERM (other than tamoxifen, toremifene)\n* Prior treatment with any PI3Kalpha (PIK3CA gene product), AKT or mTOR inhibitor\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤1 or better, with the exception of alopecia of any grade and Grade ≤2 peripheral neuropathy\n* Major surgical procedure within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study\n* History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases\n* History of leptomeningeal disease\n* Severe infection within 4 weeks prior to initiation of study treatment\n* Treatment for clinically significant infection with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan\n* Active cardiac disease or history of cardiac dysfunction\n* Positive HIV test at screening or at any time prior to screening\n* Active Hepatitis B or Hepatitis C virus infection\n* Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery, including gastric resection, potentially affecting enteral absorption\n* Known allergy or hypersensitivity to any of the study drugs or any of their excipients","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope - Orange County Lennar Foundation Cancer Center","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco (UCSF)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute (SCI)","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regional Cancer Care Associates LLC (RCCA) - Freehold Location","city":"Freehold","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Regional Cancer Care Associates LLC ? Howell Division","city":"Howell Township","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Cancer Institute","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"West Cancer Center","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flinders Medical Centre","city":"Bedford Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula Health-Frankston Hospital","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter Maccallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linear Clinical Research Limited","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Medical Center","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Ein Karem Hospital","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin MC","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assuta Medical Centers","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center","city":"Goyang-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramón y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Integral Oncológico Clara Campal Ensayos Clínicos START","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CO42867 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)","Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["duarte-california","irvine-california","san-francisco-california","santa-monica-california","stanford-california","boston-massachusetts","freehold-new-jersey","howell-township-new-jersey","charlotte-north-carolina","philadelphia-pennsylvania","pittsburgh-pennsylvania","germantown-tennessee","bedford-park-australia","frankston-australia","melbourne-australia","nedlands-australia","jerusalem-israel","haifa-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","goyang-si-south-korea","seoul-south-korea","barcelona-spain","madrid-spain","valencia-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Giredestrant for Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer","inPlainEnglish":"This is a Phase Ib/II, open-label, multicenter, randomly assigned umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.","whoItsFor":["Ages 18 Years to any","Women only","who can join for Cohort 1 (Stage 1 \\[and Stage 2, only where indicated\\]):","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1","Documented estrogen receptor-positive (ER+) tumor","Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines","Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer","Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.)","Postmenopausal status for women"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Giredestrant, Abemaciclib, or Ipatasertib. The registry lists allocation as randomized. This is a Phase Ib/II, open-label, multicenter, randomly assigned umbrella study in participants with breast cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 316 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.712Z"},{"nctId":"NCT04832698","title":"Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training","officialTitle":"Survey of Current Interventional and Diagnostic Imaging Residents After Participation in Endovascular Simulator Training Regimen","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This study looks at the comfort of interventional and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in interventional radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters.","conditions":["Malignant Vascular Neoplasm"],"keywords":[],"interventions":[{"type":"OTHER","name":"Survey Administration"}],"enrollment":9,"startDate":"2020-07-08","completionDate":"2028-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Current interventional and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey","locations":[{"facility":"M D Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joshua D Kuban","phone":"713-792-1846","email":"JDKuban@mdanderson.org"}],"primaryOutcomes":["Trainees' feelings about using simulation to help with procedural training"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Survey Administration for Malignant Vascular Neoplasm","inPlainEnglish":"This study looks at the comfort of treatment and diagnostic imaging residents in performing simulated endovascular procedures after completing training on the Mentice endovascular simulator device. Implementation of a training curriculum with radiology residents interested in treatment radiology will help facilitate hands-on training in a low-risk environment and allow for safer future patient encounters.","whoItsFor":["Ages 18 Years to any","\\- Current treatment and diagnostic radiology residents participating in the training curriculum on the Mentice Endovascular Simulator will be eligible to participate in the survey"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 9 people at Houston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.107Z"},{"nctId":"NCT04839705","title":"Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device","officialTitle":"Post-Approval Study - Post-Market Surveillance Study to Evaluate the Long-Term Safety and Effectiveness of the WEB Device","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Microvention-Terumo, Inc.","sponsorClass":"INDUSTRY","summary":"A prospective, multicenter, single arm, interventional study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation. The primary effectiveness outcome of the study is adequate intracranial aneurysm occlusion on the 1 year angiogram as adjudicated by a core laboratory.","conditions":["Wide Neck Bifurcation Intracranial Aneurysms"],"keywords":["Aneurysm","Intracranial Arterial Disease","Cerebrovascular Disorders"],"interventions":[{"type":"DEVICE","name":"WEB"}],"enrollment":200,"startDate":"2022-08-24","completionDate":"2027-05-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Patient must be ≥ 18 at the time of screening\n* Patient must have a single ruptured or unruptured IA requiring treatment\n* Patient must sign and date an IRB-approved written informed consent prior to initiation of any study procedures\n\nKey Exclusion Criteria:\n\n* Patient has an IA with characteristics unsuitable for endovascular treatment\n* Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days\n* Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days\n* Patient's index IA was previously treated\n* Patient is pregnant","locations":[{"facility":"Memorial Health Systems","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Neuroscience Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Queen's Medical Center Neuroscience Institute","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Health System","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Systems","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky, Department of Neurosurgery","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Healthcare","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU Health Sciences Center at Shreveport","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland, Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Brigham Incorporated","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMass Memorial Health","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Abbott Northwestern Hospital Allina Health","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albany Medical Center","city":"Albany","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northshore University Hospital/Northwell Health","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Stony Brook","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OhioHealth Research Institute","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Toledo Hospital d/b/a ProMedica Toledo Hospital","city":"Toledo","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania Health Systems","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmes Murphey","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Robert Gash","phone":"908-914-1045","email":"robert.gash@terumo.com"}],"primaryOutcomes":["Key Effectiveness Outcome","Key Safety Outcome"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["hollywood-florida","orlando-florida","honolulu-hawaii","iowa-city-iowa","kansas-city-kansas","lexington-kentucky","louisville-kentucky","shreveport-louisiana","baltimore-maryland","boston-massachusetts","worcester-massachusetts","minneapolis-minnesota","st-louis-missouri","albany-new-york","buffalo-new-york","manhasset-new-york","stony-brook-new-york","the-bronx-new-york","durham-north-carolina","columbus-ohio","toledo-ohio","oklahoma-city-oklahoma","philadelphia-pennsylvania","memphis-tennessee","morgantown-west-virginia"],"enrichment":{"headline":"Not a traditional drug phase: WEB for Wide Neck Bifurcation Intracranial Aneurysms","inPlainEnglish":"A prospective, multicenter, single arm, treatment study. The target patient population for this study are adult subjects with WNBAs of the anterior and posterior intracranial circulation.","whoItsFor":["Ages 18 Years to any","Patient must be ≥ 18 at the time of screening","Patient must have a single ruptured or unruptured IA requiring treatment"],"whoShouldSkip":["Patient has an IA with characteristics unsuitable for endovascular treatment","Patient has conditions placing them at high risk for ischemic stroke or has exhibited ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within the prior 30 days","Patient has had an SAH from a non-index IA or any other intracranial hemorrhage within 90 days","Patient's index IA was previously treated","Patient is pregnant"],"whatHappens":"If you join, the listed intervention(s) are WEB. The registry lists allocation as na. A prospective, multicenter, single arm, treatment study.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 29 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.439Z"},{"nctId":"NCT04846959","title":"Study to Evaluate Pregnancy Outcomes in Risankizumab Exposed Pregnancies Relative to Those Non-risankizumab Exposed Pregnancies in Women With FDA Approved Indications","officialTitle":"Risankizumab Pregnancy Exposure Registry: a Prospective Observational Study on the Safety of Risankizumab Exposure in Pregnant Women and Their Offspring","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.\n\nApproximately 818 female participants with pregnancy will be enrolled (409 participants exposed to risankizumab and 409 without exposure) at multiple sites across the United States.\n\nParticipants will not receive risankizumab as part of this study. Maternal and fetal outcomes during pregnancy for female participants who received risankizumab or other treatment will be followed for and up to 1 year after delivery\n\nThere may be a higher burden for participants in this study compared to standard of care. Participants will attend visits determined by HCPs during the study at a hospital or clinic. The pregnancy outcomes including side effects will be collected during routine clinical care.","conditions":["Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment"],"keywords":["Pregnancy","Risankizumab","SKYRIZI™","risankizumab-rzaa"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Comparator"}],"enrollment":818,"startDate":"2021-07-30","completionDate":"2032-06","sex":"FEMALE","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nRisankizumab-Exposed Cohort\n\n* US resident.\n* Current pregnancy.\n* Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.\n* Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).\n\nDiseased Comparison Cohort\n\n* US resident.\n* Current pregnancy.\n* Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting.\n* Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).\n\nExclusion Criteria:\n\nRisankizumab-Exposed Cohort\n\n* Exposure to other medications in the same class or line of therapy as risankizumab (TNF inhibitors, IL-17 inhibitors, IL-12/23 inhibitor, and other IL-23 inhibitors) at any time during pregnancy (at least 1 dose during pregnancy or prior to pregnancy within a specified time period based on the product's half-life).\n* Occurrence of pregnancy outcome prior to enrollment in the registry\n\nDiseased Comparison Cohort\n\n* Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception).\n* Occurrence of pregnancy outcome prior to enrollment in the registry","locations":[{"facility":"Evidera, a PPD Business Unit /ID# 238688","city":"Morrisville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PPD Development, LP /ID# 232134","city":"Wilmington","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"PPD Inc","phone":"1-877-302-2161","email":"glowpregnancyregistry@ppd.com"}],"primaryOutcomes":["Number of Participants with Major Congenital Malformation (MCM)"],"hasResults":false,"conditionSlugs":["psoriasis","crohns-disease"],"drugSlugs":["risankizumab"],"locationSlugs":["morrisville-north-carolina","wilmington-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: testing Risankizumab for Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, or Other Conditions for Which Risankizumab is an FDA-approved Treatment","inPlainEnglish":"The objective of this registry is to compare outcomes of risankizumab-exposed pregnancies with those of pregnancies that were not exposed to risankizumab among women with plaque psoriasis, psoriatic arthritis (PsA), Crohn's disease (CD), or other conditions for which risankizumab is an FDA-approved treatment. The registry is designed to estimate the association between risankizumab and maternal, fetal, and infant outcomes by comparing the prevalence rates of these outcomes in the exposed and unexposed populations.","whoItsFor":["Women only","Risankizumab-Exposed Cohort","Diagnosis of plaque psoriasis, PsA, CD, or other condition(s) for which Risankizumab is an FDA-approved treatment while the study is recruiting","Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception)","Diseased Comparison Cohort"],"whoShouldSkip":["Risankizumab-Exposed Cohort","Occurrence of pregnancy outcome prior to enrollment in the registry","Diseased Comparison Cohort","Exposure to risankizumab at any time during pregnancy (at least 1 dose during pregnancy or within 20 weeks prior to conception)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 818 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.587Z"},{"nctId":"NCT04847063","title":"Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies","officialTitle":"Individualized Response Assessment to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Primaries","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nCytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen. CRS with HIPEC may help people with peritoneal carcinomatosis. These are tumors that have spread to the lining of the abdomen from other cancers. Researchers think they can improve the results of CRS with HIPEC treatment on these tumors by choosing the chemotherapy drugs used in HIPEC.\n\nObjective:\n\nTo see if HIPEC after CRS can be improved, using either a model called the SMART (Sustained Microenvironment for Analysis of Resected Tissue) System or using 3-D cell culture (organoid) models, in order to test different chemotherapy drugs on tumors that were surgically removed prior to HIPEC treatment (these models are not attached to the body) versus tumors that were treated with HIPEC while still inside the body before being immediately surgically removed.\n\nEligibility:\n\nAdults ages 18 and older who have peritoneal carcinomatosis that cannot be fully removed safely with surgery.\n\nDesign:\n\nParticipants will be screened with:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nElectrocardiogram (EKG)\n\nComputed tomography (CT) scan\n\nOther imaging scans, as needed\n\nTumor biopsy, if needed\n\nLaparoscopy (small cuts are made in the abdomen, and a tube with a light and a camera is used to see the organs in the abdomen), if needed\n\nParticipants will enroll in NIH protocol #13C0176. This allows their tumor samples to be used in future research.\n\nSome screening tests may be repeated in the study.\n\nParticipants will have CRS. As many of their visible tumors will be removed as possible during surgery except for a few specific tumors left to receive the HIPEC treatment. Then they will receive HIPEC and the remaining tumors will be immediately removed. Participants will be in the hospital for 7-21 days after this surgery (CRS with HIPEC).\n\nParticipants will give tumor, fluid samples (from the abdomen during surgery), blood, saliva, cheek swab, and stool for research. They will complete surveys about their health and quality of life.\n\nParticipants with peritoneal mesothelioma (mesothelioma primary only) will have genetic (DNA) testing to determine clinical (CLIA level) germline BAP1 status for research use.\n\nParticipants will have follow-up visits for up to 5 years from CRS with HIPEC.\n\nIf there is disease progression, participants may have CRS with HIPEC again. Participants will then have follow-up visits for up to 5 years from the date of last CRS with HIPEC.","conditions":["Peritoneal Mesothelioma","Peritoneal Carcinomatosis","Ovarian Cancer","Gastrointestinal Cancer","Appendiceal Cancer","Atypical Mesothelial Proliferation","Colorectal Cancer"],"keywords":["cytoreduction","organoid model","cell culture model","SMART System","Peritoneal Metastasis","necrosis","Ki-67","cytoreductive surgery (CRS)"],"interventions":[{"type":"DRUG","name":"Sodium Thiosulfate"},{"type":"DRUG","name":"5-Fluorouracil"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Doxorubicin"},{"type":"PROCEDURE","name":"Hyperthermic Intraperitonial Chemotherapy"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Mitomycin C"}],"enrollment":60,"startDate":"2021-10-19","completionDate":"2033-12-30","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI.\n* Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score.\n* Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:\n\n  * Primary Histology: Appendiceal/Colorectal/Ovarian / PCI Cutoff for Eligibility: Total Score \\< 20 (out of 39 possible points)\n  * Primary Histology: Mesothelioma or atypical mesothelial proliferation / PCI Cutoff for Eligibility: Total Score \\<= 30 (out of 39 possible points)\n* Age \\>= 18 years.\n* ECOG performance status \\<= 1 (Karnofsky \\>= 80%).\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count \\>= 1,000/mcL\n  * Platelets \\>= 75,000/mcL\n  * Total bilirubin within \\<=1.5x institutional upper limit of normal (ULN)\n  * AST (SGOT)/ ALT (SGPT) \\<= 3x institutional upper limit of normal (ULN), or \\<= 5.0x ULN in participants with liver metastases (only)\n  * Creatinine within normal institutional limits\n\nOR\n\n--Creatinine clearance \\>= 60 mL/min/1.73 m\\^2 for participants with creatinine levels above institutional normal calculated using eGFR.\n\n* Because therapeutic agents used in this trial are known to be teratogenic, individuals of child-bearing potential (IOCBP) and individuals who are able to father a child must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 180 days after last study treatment.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of the participant to co-enroll on the tissue collection protocol 13C0176, Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors .\n\nEXCLUSION CRITERIA:\n\n* Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary.\n* Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment.\n* Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment.\n* History of allergic reactions attributed to platinum-containing compounds.\n* History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer).\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant individuals are excluded from this study because the protocol involves major abdominal surgery and chemotherapeutic agents with the potential for teratogenic or abortifacient effects. Note: Due to an unknown but potential risk for adverse events in nursing infants secondary to treatment of the participant, nursing (including breastfeeding) should be discontinued if the participant is undergoing treatment (i.e., nursing participants must agree to discontinue nursing activities).\n* HIV-positive participants with detectable viral load despite antiretroviral therapy are ineligible because of participants increased risk of lethal infections when treated with marrow-suppressive therapy. HIV-positive participants who have undetectable viral load on antiretroviral therapy may be considered for this study only after consultation with a NIAID physician.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephanie N Canady, R.N.","phone":"(240) 858-7573","email":"stephanie.canady@nih.gov"},{"name":"Andrew M Blakely, M.D.","phone":"(240) 760-7647","email":"andrew.blakely@nih.gov"}],"primaryOutcomes":["To determine the correlation between ex vivo simulated HIPEC in the SMART System or 3-D cell culture (organoid) models, and in vivo HIPEC with respect to two measures of response to treatment: percent necrosis and Ki-67"],"hasResults":false,"conditionSlugs":["colorectal-cancer","ovarian-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Sodium Thiosulfate for Peritoneal Mesothelioma","inPlainEnglish":"Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen.","whoItsFor":["Ages 18 Years to 120 Years","Confirmation of peritoneal carcinomatosis from peritoneal mesothelioma or atypical mesothelial proliferation, or from appendiceal, colorectal, or ovarian, histologies by the Laboratory of Pathology, NCI","Measurable or evaluable disease as defined by RECIST v1.1. criteria and/or by peritoneal carcinomatosis index (PCI) score","Participants must be assessed to be able to undergo optimal cytoreduction (i.e., completeness of cytoreduction score of 1 or 0) with laparoscopically assessed PCI score threshold as indicated below:","Primary Histology: Appendiceal/Colorectal/Ovarian / PCI Cutoff for Eligibility: Total Score \\< 20 (out of 39 possible points)","Primary Histology: Mesothelioma or atypical mesothelial proliferation / PCI Cutoff for Eligibility: Total Score \\<= 30 (out of 39 possible points)","how well you can do daily activities (ECOG score) \\<= 1 (Karnofsky \\>= 80%)","Participants must have adequate organ and marrow function as defined below:"],"whoShouldSkip":["Participants with known extra-abdominal metastatic disease from the participant s appendiceal, colorectal, ovarian, or peritoneal mesothelioma primary","Participants who have received intraperitoneal chemotherapy or other anti-cancer therapy within the last 4 weeks prior to the start of study treatment","Participants who have undergone major surgery within the last 12 weeks prior to the start of study treatment","History of allergic reactions attributed to platinum-containing compounds","History of dihydropyrimidine dehydrogenase deficiency (only participants with appendiceal or colorectal cancer)","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements"],"whatHappens":"If you join, the listed intervention(s) are Sodium Thiosulfate, 5-Fluorouracil, or Oxaliplatin. The registry lists allocation as randomized. Background: Cytoreductive surgery (CRS) removes tumors in the abdomen.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.069Z"},{"nctId":"NCT04858334","title":"APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation","officialTitle":"APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.","conditions":["Pancreatic Acinar Cell Carcinoma","Pancreatic Adenosquamous Carcinoma","Pancreatic Squamous Cell Carcinoma","Resectable Pancreatic Acinar Cell Carcinoma","Resectable Pancreatic Adenocarcinoma","Resectable Pancreatic Adenosquamous Carcinoma","Resectable Pancreatic Carcinoma"],"keywords":["Adjuvant","Resected Pancreatic cancer","Pancreatic adenocarcinoma","BRCA1","BRCA2","BRCA1 mutation","BRCA2 mutation","PALB2 PALB2 mutation","PARP inhibitor","PARP","Olaparib"],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Olaparib"},{"type":"DRUG","name":"Placebo Administration"}],"enrollment":152,"startDate":"2021-06-22","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA\n* Patient must be \\>= 18 years of age on day of consent\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator\n\n  * NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling\n* Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)\n* Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)\n* Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org\n* STEP 1 (RANDOMIZATION) INCLUSION CRITERIA\n* Patient must have met the eligibility criteria outlined above\n* Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)\n* Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports\n* If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing\n* Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =\\< 4 weeks prior to Step 1 randomization\n* Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy\n* Patient must be \\>= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =\\< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible\n* Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities \\> grade 1 with the exception of alopecia and/or neuropathy)\n* Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment\n* Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib\n* Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML\n* Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib\n* Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment\n* Leukocytes \\>= 3,000/mcL (obtained =\\< 28 days prior to Step 1 randomization)\n* Absolute neutrophil count \\>= 1,500/mcL (obtained =\\< 28 days prior to Step 1 randomization)\n* Platelets \\>= 100,000/mcL (obtained =\\< 28 days prior to Step 1 randomization)\n* Hemoglobin \\>= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =\\< 28 days prior to Step 1 randomization)\n* Total bilirubin =\\< 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert's syndrome. Patients with Gilbert's syndrome may enroll if direct bilirubin =\\< 2.5 x ULN of the direct bilirubin (obtained =\\< 28 days prior to Step 1 randomization)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 2.5 x institutional ULN (obtained =\\< 28 days prior to Step 1 randomization)\n* Creatinine =\\< 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance \\> 50 mL/min/1.73 m\\^2 (obtained =\\< 28 days prior to Step 1 randomization)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT \\[QTc\\] prolongation \\> 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome\n* Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited\n* Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers\n* Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures\n* Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent\n* Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate\n* Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Anchorage Oncology Centre","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Fairbanks Memorial Hospital","city":"Fairbanks","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kingman Regional Medical Center","city":"Kingman","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"CHI Saint Vincent Cancer Center Hot Springs","city":"Hot Springs","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Mission Hope Medical Oncology - Arroyo Grande","city":"Arroyo Grande","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"PCR Oncology","city":"Arroyo Grande","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alta Bates Summit Medical Center-Herrick Campus","city":"Berkeley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Joseph Medical Center/Disney Family Cancer Center","city":"Burbank","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Medical Center","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Gynecologic Oncology","city":"Mountain View","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Joseph Hospital - Orange","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Roseville Medical Center","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Medical Center Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Pacific Medical Center-Pacific Campus","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Central Coast Health Center-San Luis Obispo","city":"San Luis Obispo","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mills Health Center","city":"San Mateo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Santa Cruz","city":"Santa Cruz","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Hope Medical Oncology - Santa Maria","city":"Santa Maria","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation - Santa Rosa","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Pacific Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Santa Rosa Memorial Hospital","city":"Santa Rosa","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Sunnyvale","city":"Sunnyvale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northbay Cancer Center","city":"Vacaville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penrose-Saint Francis Healthcare","city":"Colorado Springs","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers-Penrose","city":"Colorado Springs","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Porter","city":"Denver","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"CommonSpirit Cancer Center Mercy","city":"Durango","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center","city":"Durango","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CommonSpirit Saint Anthony Hospital Cancer Center","city":"Lakewood","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Littleton","city":"Littleton","state":"Colorado","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Longmont United Hospital","city":"Longmont","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers-Longmont","city":"Longmont","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth 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2: testing Olaparib for Pancreatic Acinar Cell Carcinoma","inPlainEnglish":"This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged.","whoItsFor":["Ages 18 Years to any","STEP 0 (PRE-REGISTRATION) who can join","Patient must be \\>= 18 years of age on day of consent","Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2","Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator","NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling","Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)","STEP 1 (RANDOMIZATION) who can join"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Magnetic Resonance Imaging. The registry lists allocation as randomized. This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 152 people at 456 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.467Z"},{"nctId":"NCT04864886","title":"Metabolic Profiling of Immune Responses in Immune-mediated Diseases","officialTitle":"Metabolic Profiling of Immune Responses in Immune-Mediated Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nThe immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response.\n\nObjective:\n\nTo learn about how the immune system and skin healing are related to each other.\n\nEligibility:\n\nPeople ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test.\n\nParticipants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions.\n\nParticipants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil.\n\nParticipants will give at least 1 blood sample.\n\nParticipants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm.\n\nParticipants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed.\n\nParticipants may give leftover samples taken as part of their regular medical care.\n\nParticipation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.","conditions":["Primary Immunodeficiency","Psoriasis","Atopic Dermatitis","Immune-mediated Diseases"],"keywords":["Primary Immunodeficiency","Psoriasis","Atopic Dermatitis","pathways","Natural History"],"interventions":[],"enrollment":300,"startDate":"2021-08-10","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Meets one of the following:\n\n   1. Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or\n   2. Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or\n   3. Has physician-diagnosed psoriasis; or\n   4. Has physician-diagnosed AD; or\n   5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).\n2. Aged 18 to 75 years.\n3. Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.\n4. Able to provide informed consent.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).\n2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.\n3. History of keloid formation.\n4. Pregnancy, lactating, or breastfeeding.\n5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.\n\nCo-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jodi L Blake, R.N.","phone":"(301) 605-2896","email":"jodi.blake@nih.gov"},{"name":"Ian A Myles, M.D.","phone":"(301) 451-8420","email":"mylesi@niaid.nih.gov"}],"primaryOutcomes":["Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune mediated disorders.","Fold difference in metabolic pathways associated with immune pathways.","Fold differences in metabolic pathways related to wound healing."],"hasResults":false,"conditionSlugs":["als","psoriasis","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Metabolic Profiling of Immune Responses in Immune-mediated Diseases","inPlainEnglish":"Background: The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal.","whoItsFor":["Ages 18 Years to 75 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Meets one of the following:","Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or","Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or","Has physician-diagnosed psoriasis; or","Has physician-diagnosed AD; or","Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs)","Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator","History of keloid formation","Pregnancy, lactating, or breastfeeding","Any condition that, in the opinion of the investigator, contraindicates participation in the study","Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.577Z"},{"nctId":"NCT04871542","title":"Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors","officialTitle":"Immune Checkpoint Inhibitor Toxicity (I-CHECKIT): A Prospective Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"SWOG Cancer Research Network","sponsorClass":"NETWORK","summary":"This study examines how certain risk factors (such as age, gender, other medical conditions, and the type of immunotherapy used to treat the cancer) affect whether a patient with a malignant solid tumor will develop mild or serious side effects from the immunotherapy medications. Immunotherapy is the type of treatment that helps the body's immune system fight cancer. In the future, this information may help doctors make better decisions about cancer treatments.","conditions":["Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":2062,"startDate":"2021-09-13","completionDate":"2030-05-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be planning to receive ICI-based therapy for a solid tumor malignancy. This therapy must be given according to Food and Drug Administration (FDA) label or National Comprehensive Cancer Network (NCCN) guidelines at Category 1 or 2A and not in the context of a clinical trial\n* Participants who have received prior ICI-based therapy must have completed ICI based therapy at least 180 days prior to registration\n* Participants must not have discontinued any prior ICI-based therapy (if applicable) because of irAE\n* Participants must not have received chemotherapy, biologic, or targeted-therapy within 21 days prior to registration\n* Participants must have recovered from side effects of prior therapy to the following standards per treating physician's discretion:\n\n  * =\\< Grade 1 for any non-hematologic side effects (excluding neuropathy and alopecia); lab-related parameters of liver and renal function will be considered at the discretion of the treating physician)\n  * =\\< Grade 2 for neuropathy and/or alopecia\n  * Grade 3 or less for any hematologic side effects\n* Participants must be planning to begin standard of care ICI-based therapy within 3 calendar days after registration\n* Participants must not be planning to receive ICI-based therapy in combination with chemotherapy or any other non-ICI therapy for treatment of their cancer\n* Participants must be at least 18 years of age\n* Participants must complete their history and physical examination within 28 days prior to registration\n* Participants who can complete the S2013 Feasibility Questionnaire in English or Spanish must participate at the scheduled assessments\n* Participants must be able to complete Patient-Reported Outcome (PRO) instruments in English, Spanish, or French and must be planning to complete PROs at all scheduled assessments\n* Participants must complete the pre-registration (baseline) PRO forms within 14 days prior to registration\n* Participants must be willing to participate in PRO data collection\n\n  * Note: Prior to registration, participants must decide on their method (paper or electronic) of completing their follow-up questionnaires. Participants who elect electronic (ePRO) completion must have an iPhone, Android phone, or tablet with cellular or WiFi connectivity in order to download the Patient Cloud mobile applications onto the device (personal device or a site provisioned device for multi-users)\n* Participants must be offered the opportunity to participate in the optional specimen banking\n* Note: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation 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Site","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hanoi","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Number of participants with adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan","st-louis-missouri","new-york-new-york","cincinnati-ohio","portland-oregon","dallas-texas","houston-texas","salt-lake-city-utah","milwaukee-wisconsin","caba-argentina","capital-federal-argentina","graz-austria","vienna-austria","rio-de-janeiro-brazil","s-o-paulo-brazil","varna-bulgaria","montreal-canada","chongqing-china","guangzhou-china","zhengzhou-china","wuhan-china","changchun-china","xian-china","chengdu-china","beijing-china","shanghai-china","shenyang-china","tianjin-china","ostrava-czechia","brno-czechia","copenhagen-denmark","bordeaux-france","lyon-france","marseille-france","nantes-france","paris-france","vand-uvre-l-s-nancy-france","frankfurt-am-main-germany","jena-germany","berlin-germany","kiel-germany","milan-italy","roma-italy","naples-italy","kobe-japan","beirut-lebanon","george-town-malaysia","johor-bahru-malaysia","kuala-selangor-malaysia","monterrey-mexico","khoudh-oman","katowice-poland","krakow-poland","warsaw-poland","wroclaw-poland","lisbon-portugal","porto-portugal","timi-oara-romania","moscow-russia","saint-petersburg-russia","riyadh-saudi-arabia","singapore-singapore","uijeongbu-si-south-korea","busan-south-korea","jeollanam-south-korea","seoul-south-korea","santiago-compostela-spain","badalona-spain","lhospitalet-de-llobregat-spain","bilbao-spain","santa-cruz-spain","barcelona-spain","madrid-spain","seville-spain","valencia-spain","taoyuan-taiwan","samsun-turkey-t-rkiye","london-united-kingdom","oxford-united-kingdom","hanoi-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 4: testing Asciminib single agent for Chronic Myelogenous Leukemia","inPlainEnglish":"This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment","whoItsFor":["Ages 7 Years to 100 Years","Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures"],"whoShouldSkip":["Participant has been discontinued from parent study treatment","Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study","Participant's ongoing treatment is currently approved and reimbursed at country level","Pregnant or nursing (lactating) women","Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment","Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information","Applicable for participants on bosutinib treatment at the end of the CABL001A2301 and on other TKIs for CABL001A2202 study that switch to asciminib treatment:"],"whatHappens":"If you join, the listed intervention(s) are Asciminib single agent, Imatinib, or Nilotinib. The registry lists allocation as randomized. This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 347 people at 81 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.822Z"},{"nctId":"NCT04877977","title":"Long-term Observation of Participants With Mood Disorders","officialTitle":"Long-term Observation of Participants With Mood Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nMore than 12,000 people have taken part in research at the Experimental Therapeutics \\& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments.\n\nObjective:\n\nTo learn the long-term impact of depression, bipolar disorder, and suicide risk.\n\nEligibility:\n\nAdults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago.\n\nDesign:\n\nThis study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact.\n\nIn Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview.\n\nIn Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH.\n\nIn both phases, participants can skip any questions they do not want to answer.\n\nThe online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours.\n\nThe information that participants give in this study may be linked to their other NIH research records.","conditions":["Depression","Suicide Risk"],"keywords":["Depression","Suicide","Ketamine","Neuroimaging","Treatment Resistant Depression","Natural History"],"interventions":[],"enrollment":1000,"startDate":"2021-08-17","completionDate":"2028-10-01","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago.\n2. Age 18 years or older\n3. Able to provide informed consent online using study website or over the telephone\n4. Able to read and write English\n\nEXCLUSION CRITERIA:\n\nNone.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elizabeth D Ballard, Ph.D.","phone":"(301) 435-9399","email":"elizabeth.ballard@nih.gov"}],"primaryOutcomes":["Score on Beck Depression Inventory (suicide item removed)"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Long-term Observation of Participants With Mood Disorders","inPlainEnglish":"Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \\& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk.","whoItsFor":["Ages 18 Years to 99 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Participants who signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers over a year ago","Age 18 years or older","Able to read and write English"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.789Z"},{"nctId":"NCT04880356","title":"Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.","officialTitle":"Clinical, Instrumental and Laboratory Data Collection of Subjects With Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","sponsorClass":"OTHER","summary":"General aim of the study is the improvement of the clinical knowledge of ultra-rare inherited metabolic and degenerative neurological diseases (prevalence less than 5:100,000) in adulthood through the systematic longitudinal collection of clinical, laboratory and instrumental data.","conditions":["Inherited Disease","Rare Diseases","Metabolic Disease","Undiagnosed Disease","Neurologic Disorder","Neuro-Degenerative Disease"],"keywords":["Leukodystrophies,","Adrenoleukodystrophy,","Metachromatic leukodystrophy,","Krabbe disease,","Vanishing White Matter Syndrome,","Alexander disease,","Hereditary Leukodystrophy with Spheroids (CSF1R-related HLDS),","Nasu-Hakola disease (TREM2- and TYROBP-related disease)","Leukoencephalopathy, progressive, with ovarian failure (LKENP, AARS2-related),","Pelizaeus-Merzbacher disease,","Pelizaeus-Merzbacher-like disease,","Hypomyelinating leukodystrophies,","Leukodystrophies with calcifications and cysts (LCC),","Leukoencephalopathy with ataxia disease (LKPAT, CLCN2-related),","L-2-Hydroxyglutaric aciduria,","Polyglucosan bodies disease,","Methylmalonic acidemia with homocystinuria,","Niemann-pick type C,","Fahr's disease,","Wilson's disease,","Cerebrotendinous Xanthomatosis,","Sphingolipidoses"],"interventions":[{"type":"OTHER","name":"collection of data"}],"enrollment":100,"startDate":"2021-03-01","completionDate":"2031-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>= 18 years\n* Subjects with ultra-rare inherited degenerative and metabolic neurological diseases\n* Subjects with undiagnosed neurological diseases (when supposed to be inherited)\n\nExclusion Criteria:\n\n* none","locations":[{"facility":"Fondazione IRCCS Istituto Neurologico Carlo Besta","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ettore Salsano, MD","phone":"+39022394","email":"ettore.salsano@istituto-besta.it"},{"name":"Renato Mantegazza, MD","phone":"+39022394","email":"crc@istituto-besta.it"}],"primaryOutcomes":["Verbal (letter) fluency","Stance and gait performances [Time Frame: 10 years] Stance and gait performances","Upper limb motor function","Swallowing function (dysphagia)","Speech function (dysarthria)","Bladder function","Sleep","Quality of life"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: collection of data for Inherited Disease","inPlainEnglish":"General aim of the study is the improvement of the clinical knowledge of ultra-rare inherited metabolic and degenerative neurological diseases (prevalence less than 5:100,000) in adulthood through the systematic longitudinal collection of clinical, laboratory and instrumental data.","whoItsFor":["Ages 18 Years to any","Subjects with ultra-rare inherited degenerative and metabolic neurological diseases","Subjects with undiagnosed neurological diseases (when supposed to be inherited)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Milan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.173Z"},{"nctId":"NCT04916327","title":"Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1","officialTitle":"Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Virginia Commonwealth University","sponsorClass":"OTHER","summary":"The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).","conditions":["Peripheral Vascular Diseases"],"keywords":["cardiovascular disease","vascular function","PTSD","GAD","Oxidant"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Antioxidant"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":720,"startDate":"2021-08-23","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease\n* for PTSD group, a score of ≥ 33 on PCL-5 checklist\n* for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\< 33 on the PCL-5 checklist\n* for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\< 33 on the PCL-5 checklist\n\nExclusion Criteria:\n\n* taking medications that could influence cardiovascular function\n* current smokers who have recently quit smoking\n* illicit drug use or excessive alcohol consumption\n* pregnant women\n* significant calorie restriction or vitamin/mineral deficiencies\n* limited English proficiency","locations":[{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ryan Garten, PhD","phone":"(804) 828-1948","email":"rsgarten@vcu.edu"}],"primaryOutcomes":["Arm Vascular Function at Rest (Flow Mediated Dilation Test)","Leg Vascular Function (Passive Leg Movement Test)","Arm Vascular Function in Response to Exercise (Handgrip Exercise Test)"],"hasResults":false,"conditionSlugs":["als","ptsd","anxiety"],"drugSlugs":[],"locationSlugs":["richmond-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Antioxidant for Peripheral Vascular Diseases","inPlainEnglish":"The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).","whoItsFor":["Ages 18 Years to 35 Years","apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease","for PTSD group, a score of ≥ 33 on PCL-5 checklist","for GAD group, a score of ≥ 10 on the GAD-7 self-report scale and \\< 33 on the PCL-5 checklist","for Healthy Control group, a score of ≤ 10 on the GAD-7 self-report scale and \\< 33 on the PCL-5 checklist"],"whoShouldSkip":["taking medications that could influence cardiovascular function","current smokers who have recently quit smoking","illicit drug use or excessive alcohol consumption","significant calorie restriction or vitamin/mineral deficiencies","limited English proficiency"],"whatHappens":"If you join, the listed intervention(s) are Antioxidant, or Placebo. The registry lists allocation as randomized. The purpose of this research study is to examine the role oxidants, substances produced in the blood that can damage blood vessel function, may play in blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (PTSD) and/or generalized anxiety disorder (GAD)).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 720 people at Richmond. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.353Z"},{"nctId":"NCT04924075","title":"Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)","officialTitle":"A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).","conditions":["Pheochromocytoma/Paraganglioma","Pancreatic Neuroendocrine Tumor","Von Hippel-Lindau Disease","Advanced Gastrointestinal Stromal Tumor","HIF-2α Mutated Cancers"],"keywords":["HIF-2α","Pheochromocytoma/paraganglioma","Pancreatic NET"],"interventions":[{"type":"DRUG","name":"Belzutifan"}],"enrollment":355,"startDate":"2021-08-12","completionDate":"2032-11-18","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The main inclusion criteria include but are not limited to the following:\n\n* Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)\n* Diagnosis of one of the following: Advanced/metastatic pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations\n* Cohort B1: VHL Disease-associated tumors:\n\n  * Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis\n  * Must be ≥18 years of age\n* Has a life expectancy of at least 3 months\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan\n* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* Any of the following: A pulse oximeter reading \\<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure\n* Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention","locations":[{"facility":"Cedars-Sinai Medical Center ( Site 0110)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University - Robert H. Lurie Comprehensive Cancer Center ( Site 0130)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center - Warrenville ( Site 0134)","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa ( Site 0104)","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - Developmental Therapeutics ( Site 0108)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health ( Site 0125)","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital ( Site 0111)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan ( Site 0126)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University-Internal Medicine/Oncology ( Site 0124)","city":"St Louis","state":"Missouri","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai ( Site 0123)","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine: University of Pennsylvania Health System-Heme/Onc ( Site 0127)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 7000)","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center ( Site 0107)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center ( Site 0112)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital-Medical Oncology ( Site 1601)","city":"Randwick","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Melbourne Hospital ( Site 1602)","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur J.E. Child Comprehensive Cancer Centre ( Site 0203)","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0202)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Arturo López Pérez ( Site 2200)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oncología de Precisión ( Site 2203)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital-Urology ( Site 1900)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer Center ( Site 1905)","city":"Guangzhou","state":"Guangdong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1904)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University ( Site 1906)","city":"Chengdu","state":"Sichuan","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rigshospitalet ( Site 0304)","city":"Copenhagen","state":"Capital Region","country":"Denmark","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet-Department of Endocrinology ( Site 0303)","city":"Copenhagen","state":"Capital Region","country":"Denmark","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Odense Universitetshospital ( Site 0302)","city":"Odense C","state":"Region Syddanmark","country":"Denmark","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHU Strasbourg-Hautepierre-Medecine Interne, Endocrinologie et Nutrition ( Site 0402)","city":"Strasbourg","state":"Alsace","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Edouard Herriot-oncologie ( Site 0405)","city":"Lyon","state":"Auvergne-Rhône-Alpes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli-Calmettes-Oncology ( Site 0406)","city":"Marseille","state":"Bouches-du-Rhone","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre ( Site 0407)","city":"Le Kremlin-Bicêtre","state":"Paris","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0404)","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy ( Site 0403)","city":"Villejuif","state":"Île-de-France Region","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Freiburg ( Site 0504)","city":"Freiburg im Breisgau","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Department of Internal Medicine IV, Division ( Site 0501)","city":"München","state":"Bavaria","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Comprehensive Cancer Center Mainfranken-Div. of Endocrinology and Diabetes ( Site 0500)","city":"Würzburg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 0505)","city":"Düsseldorf","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité Universitaetsmedizin Berlin - Campus Mitte-Department of Endocrinology and Metabolism ( Site 0503)","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis University-Belgyógyászati és Onkológiai Klinika Hematológia Osztály ( Site 0600)","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center-Institute of Endocrinology, Diabetes and Metabolism ( Site 1400)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center ( Site 1401)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Naples Federico II-Dipartimento di Medicina Clinica e Chirurgia ( Site 0704)","city":"Naples","state":"Campania","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori-S.C. Oncologia Medica 2- Sarcomi ( Site 0709)","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Senese-U.O.C. Immunoterapia Oncologica ( Site 0706)","city":"Siena","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 0708)","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 0701)","city":"Brescia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele-Oncologia Medica ( Site 0705)","city":"Milan","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroe ( Site 0700)","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Ricerche Cliniche di Verona ( Site 0703)","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital ( Site 1800)","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Yokohama City University Hospital ( Site 1804)","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kochi Medical School Hospital ( Site 1807)","city":"Nankoku","state":"Kochi","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital ( Site 1802)","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kyoto University Hospital ( Site 1806)","city":"Kyoto","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Kyoto Medical Center ( Site 1812)","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Women's Medical University Adachi Medical Center ( Site 1803)","city":"Tokyo","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht ( Site 1530)","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo Universitetssykehus Radiumhospitalet ( Site 2400)","city":"Oslo","state":"","country":"Norway","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"START Lisbon - Hospital de Santa Maria ( Site 2601)","city":"Lisbon","state":"Lisbon District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E. ( Site 2600)","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"GBUZ Republican Clinical Oncological Dispensary ( Site 0804)","city":"Ufa","state":"Baskortostan, Respublika","country":"Russia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Saint Petersburg State University-Clinic of advanced medical technologies n. a. Nicolay I. Pirogov ( Site 0805)","city":"Saint Petersburg","state":"Leningradskaya Oblast'","country":"Russia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 0803)","city":"Saint Petersburg","state":"Leningradskaya Oblast'","country":"Russia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF ( Site 0801)","city":"Moscow","state":"Moscow","country":"Russia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Endocrinology Research Center of Rosmedtechnologies-Surgery ( Site 0809)","city":"Moscow","state":"Moscow","country":"Russia","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore ( Site 1700)","city":"Singapore","state":"Central Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 2001)","city":"Jongno-gu","state":"Seoul","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 2000)","city":"Songpa-gu","state":"Seoul","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center-Oncology ( Site 1102)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1103)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Central de Asturias-Medical Oncology ( Site 1101)","city":"Oviedo","state":"Principality of Asturias","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron ( Site 1100)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skanes University Hospital Lund ( Site 1200)","city":"Lund","state":"Skåne County","country":"Sweden","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Karolinska Universitetssjukhuset Solna ( Site 1202)","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"COMPLETED","lat":null,"lon":null},{"facility":"Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1201)","city":"Uppsala","state":"Uppsala County","country":"Sweden","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sahlgrenska Universitetssjukhuset-Department of Oncology CTU Clinical Trial Unit ( Site 1204)","city":"Gothenburg","state":"Västra Götaland County","country":"Sweden","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Baskent University Adana Training Hospital ( Site 0906)","city":"Yüreğir","state":"Adana","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ege University Medicine of Faculty ( Site 0900)","city":"Bornova","state":"İzmir","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universitesi-oncology hospital ( Site 0901)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent Şehir Hastanesi. ( Site 0904)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Universitesi Cerrahpasa-Medical Oncology ( Site 0902)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"COMPLETED","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital ( Site 1309)","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Free Hospital ( Site 1302)","city":"London","state":"England","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Beatson West of Scotland Cancer Centre ( Site 1308)","city":"Glasgow","state":"Glasgow City","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital-Medical Oncology ( Site 1304)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","chicago-illinois","warrenville-illinois","iowa-city-iowa","baltimore-maryland","bethesda-maryland","boston-massachusetts","ann-arbor-michigan","st-louis-missouri","new-york-new-york","philadelphia-pennsylvania","nashville-tennessee","houston-texas","randwick-australia","parkville-australia","calgary-canada","toronto-canada","santiago-chile","beijing-china","guangzhou-china","shanghai-china","chengdu-china","copenhagen-denmark","odense-c-denmark","strasbourg-france","lyon-france","marseille-france","le-kremlin-bic-tre-france","paris-france","villejuif-france","freiburg-im-breisgau-germany","m-nchen-germany","w-rzburg-germany","d-sseldorf-germany","berlin-germany","budapest-hungary","ramat-gan-israel","tel-aviv-israel","naples-italy","milan-italy","siena-italy","bologna-italy","brescia-italy","verona-italy","sapporo-japan","yokohama-japan","nankoku-japan","chuo-ku-japan","kyoto-japan","tokyo-japan","utrecht-netherlands","oslo-norway","lisbon-portugal","porto-portugal","ufa-russia","saint-petersburg-russia","moscow-russia","singapore-singapore","jongno-gu-south-korea","songpa-gu-south-korea","madrid-spain","oviedo-spain","barcelona-spain","lund-sweden","stockholm-sweden","uppsala-sweden","gothenburg-sweden","y-re-ir-turkey-t-rkiye","bornova-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","cambridge-united-kingdom","london-united-kingdom","glasgow-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Belzutifan for Pheochromocytoma/Paraganglioma","inPlainEnglish":"This is a study to measure the how well it works and safety of belzutifan this drug alone in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to measure the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).","whoItsFor":["Ages 12 Years to any","The main include but are not limited to the following:","Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)","Cohort B1: VHL Disease-associated tumors:","Have a diagnosis of VHL disease as determined by a germline test locally and/or clinical diagnosis","Must be ≥18 years of age","Has a life expectancy of at least 3 months"],"whoShouldSkip":["include but are not limited to the following:","Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan","History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years","Any of the following: A pulse oximeter reading \\<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen","Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure","Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention"],"whatHappens":"If you join, the listed intervention(s) are Belzutifan. The registry lists allocation as na. This is a study to measure the how well it works and safety of belzutifan this drug alone in participants with advanced pheochromocytoma/paraganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 355 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.436Z"},{"nctId":"NCT04927416","title":"The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer","officialTitle":"The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Background:\n\nAbout 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment options are limited and generally not effective. Researchers want to see if they can better detect thyroid tumors by using a compound called 68Gallium-DOTATATE. This compound may bind to a tumor and make it visible during a positron emission tomography/computed tomography (PET/CT) scan. This information might help guide future research and treatment.\n\nObjective:\n\nTo identify the people with thyroid cancer whose tumors have a high uptake of 68Gallium-DOTATATE as analyzed by imaging with PET/CT.\n\nEligibility:\n\nPeople ages 18 years and older with thyroid cancer that has spread outside of the thyroid.\n\nDesign:\n\nParticipants will have a medical exam. They will give blood and urine samples. Some samples will be used for research.\n\nParticipants will have imaging scans that follow standard of care. These scans may include:\n\nCT scan of the neck, chest, abdomen, and pelvis\n\nBone scan\n\nMagnetic resonance imaging of the brain, spine, or liver\n\n18-FDG-PET/CT as needed\n\nParticipants will have a PET/CT scan. They will get an intravenous (IV) line. They will get an IV injection of 68Gallium-DOTATATE. It contains radioactive tracers. The PET/CT scanner is shaped like a large donut. It contains crystals. The crystals pick up small radiation signals that are given off by the tracers. The CT part of the scan uses low-dose x-rays. The pictures made by the scanner show where the tracers are in the body. The session will last 90 minutes.\n\nParticipation will last for about 3 months.","conditions":["Metastic Thyroid Cancer"],"keywords":["Thyroid Cancer","Metastases","Ga68-DOTATATE","Somatostatin Receptors","Positron Emission Tomography"],"interventions":[{"type":"DRUG","name":"68-Gallium-DOTATATE-PET/CT"}],"enrollment":54,"startDate":"2021-10-25","completionDate":"2030-11-30","sex":"ALL","minAge":"18 Years","maxAge":"98 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nData prospectively collected from the 28 subjects enrolled under this protocol, and data from 26 subjects collected under 77-DK-0096 and/or 00-CH-0093 will be analyzed. Among the 26 subjects prospectively evaluated under 77-DK-0096 protocol, 21 out of 26 had research 68Ga-DOTATATE PET/CT performed under the DOTATATE sub-study of 77-DK-0096, and 5 out of 26 had 68Ga-DOTATATE PET/CT done under 00-CH-0093. Again, the inclusion of the above data was per the IRB s request to transition the sub-study into a new standalone protocol. This will give us a total of 54 subjects for the final analyses, with at least 18 subjects from each group (e.g., HTC, DTC, and MTC), which is required to meet the primary objectives of this study with sufficient power of 80% and type 1 error alpha of \\< 0.05.\n\nPatients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Ga-DOTATATE PET/CT imaging informed consent form. The same inclusion/exclusion criteria were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093.\n\nIn order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria:\n\n* Male or female, aged \\>18 years.\n* Patients with established thyroid cancer diagnosis presenting with either:\n\n  * Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS)\n\nOR\n\n--Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI.\n\nIn order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria:\n\n* Male or female, aged \\>18 years.\n* Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level \\> 500 pg/mL.\n\nEXCLUSION CRITERIA:\n\nSubjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study:\n\n* Pregnancy or lactation by self-report.\n* Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;\n* Patients unable to give informed consent.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Padmasree Veeraraghavan, R.N.","phone":"(301) 451-7710","email":"padmasree.veeraraghavan@nih.gov"},{"name":"Joanna Klubo-Gwiezdzinska, M.D.","phone":"(301) 496-5052","email":"joanna.klubo-gwiezdzinska@nih.gov"}],"primaryOutcomes":["Prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing 68-Gallium-DOTATATE-PET/CT for Metastic Thyroid Cancer","inPlainEnglish":"Background: About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment options are limited and generally not effective.","whoItsFor":["Ages 18 Years to 98 Years"],"whoShouldSkip":["were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093","In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria:","Male or female, aged \\>18 years","Patients with established thyroid cancer diagnosis presenting with either:","Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS)","Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 1.1 criteria after therapy with RAI","In order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria:"],"whatHappens":"If you join, the listed intervention(s) are 68-Gallium-DOTATATE-PET/CT. The registry lists allocation as randomized. Background: About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.336Z"},{"nctId":"NCT04929223","title":"A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","officialTitle":"A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.","conditions":["Metastatic Colorectal Cancer"],"keywords":["KRAS G12C"],"interventions":[{"type":"DRUG","name":"Inavolisib"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Cetuximab"},{"type":"DRUG","name":"Atezolizumab"},{"type":"DRUG","name":"Tiragolumab"},{"type":"DRUG","name":"SY-5609"},{"type":"DRUG","name":"Divarasib"},{"type":"DRUG","name":"FOLFOX"},{"type":"DRUG","name":"FOLFIRI"},{"type":"DIAGNOSTIC_TEST","name":"FoundationOne®Liquid CDx"}],"enrollment":542,"startDate":"2021-10-22","completionDate":"2030-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Signed cohort-specific Informed Consent Form\n* Age \\>= 18 years at time of signing Informed Consent Form\n* Biomarker eligibility as determined by:\n\n  * A validated test approved by local health authorities for detection of the specified biomarkers/mutations.\n  * A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.\n  * Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR\n  * Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of \\<= 1\n* Life expectancy \\>= 3 months, as determined by the investigator\n* Histologically confirmed adenocarcinoma originating from the colon or rectum\n* Metastatic disease\n* Prior therapies for metastatic disease\n* Ability to comply with the study protocol, in the investigators judgment\n* Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures\n* For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm\n\nExclusion Criteria\n\n* Current participation or enrollment in another interventional clinical trial. Participants who are participating in the follow-up period of an interventional clinical trial are eligible for the study.\n* Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment\n* Treatment with investigational therapy within 28 days prior to initiation of study treatment\n* Pregnant or breastfeeding, or intending to become pregnant during the study\n* History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study\n* Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety\n* Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or efficacy of study treatment\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)\n* Uncontrolled tumor-related pain\n* Uncontrolled or symptomatic hypercalcemia\n* Clinically significant and active liver disease\n* Negative HIV test at screening, with the following exception: Participants with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count greater than or equal to 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n* Symptomatic, untreated, or actively progressing CNS metastases\n* History of leptomeningeal disease or carcinomatous meningitis\n* History of malignancy other than CRC within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Any other disease, unresolved toxicity from prior therapy, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications\n* Requirement for treatment with any medicinal product that contraindicates the use of any of the study treatments, may interfere with the planned treatment, affects participant compliance, or puts the patient at higher risk for treatment-related complications","locations":[{"facility":"UAB Comprehensive Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"cCare","city":"Encinitas","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"USC Norris Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian","city":"Newport Beach","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Stanford Cancer Center","city":"Stanford","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers, LLP","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Ct Hema/Onco Assoc","city":"Norwich","state":"Connecticut","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Cancer Specialists","city":"Arlington Heights","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Bird Perkins Cancer Ctr","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Cancer & Blood Specialists - New Hyde Park","city":"New Hyde Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Cancer and Blood Specialists-Central Park Hematology & Oncology","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Cancer & Blood Specialists","city":"Port Jefferson Station","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Cancer & Blood Specialists - Bronx","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hematology Oncology Salem","city":"Salem","state":"Oregon","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UPMC - Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute / Tennessee Oncology","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas","city":"Denton","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lumi Research","city":"Kingwood","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Texas Oncology - Gulf Coast","city":"Webster","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Inst.","city":"Seattle","state":"Washington","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Medical Oncology Associates","city":"Spokane","state":"Washington","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Peter Maccallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Center","city":"Toronto","state":"Ontario","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital","city":"Montreal","state":"Quebec","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"McGill University Health Center","city":"Montreal","state":"Quebec","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Herlev Hospital, Afdeling for Kræftbehandling, Center for Kræftforskning, Klinisk Forskningsenhed","city":"Herlev","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet, Onkologisk Klinik","city":"København Ø","state":"","country":"Denmark","status":"COMPLETED","lat":null,"lon":null},{"facility":"Charité Universitätsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital","city":"Bochum","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Düsseldorf","city":"Düsseldorf","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Klinik Altona","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III","city":"Heilbronn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum der Universität München, Campus Großhadern","city":"München","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Universitätsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Università degli Studi della Campania Luigi Vanvitelli","city":"Naples","state":"Campania","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS","city":"Meldola","state":"Emilia-Romagna","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Universitario Agostino Gemelli IRCCS","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irccs Istituto Nazionale Dei Tumori (Int)","city":"Milan","state":"Lombardy","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Oncologico Veneto (IOV)","city":"Padova","state":"Veneto","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii","city":"Krakow","state":"","country":"Poland","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny w Poznaniu","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie","city":"Warsaw","state":"","country":"Poland","status":"SUSPENDED","lat":null,"lon":null},{"facility":"National Cancer Center","city":"Goyang-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chonnam National University Hwasun Hospital","city":"Jeollanam-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Donostia","city":"Donostia / San Sebastian","state":"Guipuzcoa","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Puerta de Hierro - Majadahonda","city":"Majadahonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall d'Hebron Institute of Oncology (VHIO), Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid-FJD, Hospital Fundacion Jimenez Diaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid. Centro Integral Oncologico Clara Campal","city":"Madrid","state":"","country":"Spain","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Hospital Clínico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario Lozano Blesa","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Zhongzheng Dist.","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrookes Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre","city":"Cardiff","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Free Hospital","city":"London","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Royal Marsden Hospital;Dept of Med-Onc","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"Sutton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: WO42758 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Objective Response Rate"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","duarte-california","encinitas-california","los-angeles-california","newport-beach-california","stanford-california","aurora-colorado","lone-tree-colorado","new-haven-connecticut","norwich-connecticut","jacksonville-florida","tampa-florida","arlington-heights-illinois","baton-rouge-louisiana","boston-massachusetts","detroit-michigan","rochester-minnesota","new-hyde-park-new-york","new-york-new-york","port-jefferson-station-new-york","the-bronx-new-york","durham-north-carolina","salem-oregon","pittsburgh-pennsylvania","nashville-tennessee","denton-texas","kingwood-texas","webster-texas","seattle-washington","spokane-washington","melbourne-australia","toronto-canada","montreal-canada","herlev-denmark","k-benhavn-denmark","berlin-germany","bochum-germany","dresden-germany","d-sseldorf-germany","hamburg-germany","heilbronn-germany","m-nchen-germany","ulm-germany","naples-italy","meldola-italy","rome-italy","milan-italy","padova-italy","gdansk-poland","krakow-poland","poznan-poland","warsaw-poland","goyang-si-south-korea","jeollanam-do-south-korea","seongnam-si-south-korea","seoul-south-korea","donostia-san-sebastian-spain","majadahonda-spain","barcelona-spain","madrid-spain","valencia-spain","zaragoza-spain","tainan-taiwan","taipei-taiwan","zhongzheng-dist-taiwan","cambridge-united-kingdom","cardiff-united-kingdom","london-united-kingdom","manchester-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Inavolisib for Metastatic Colorectal Cancer","inPlainEnglish":"This open-label, exploratory study is designed to measure the safety and how well it works of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.","whoItsFor":["Ages 18 Years to any","Biomarker eligibility as determined by:","A validated test approved by local health authorities for detection of the specified biomarkers/mutations","A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers","Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy","Eastern Cooperative Oncology Group (ECOG) Performance Status of \\<= 1","Life expectancy \\>= 3 months, as determined by the investigator","Histologically confirmed adenocarcinoma originating from the colon or rectum"],"whoShouldSkip":["Current participation or enrollment in another treatment clinical trial. Participants who are participating in the follow-up period of an treatment clinical trial are eligible for the study","Any systemic anti-cancer treatment within 2 weeks or 5 half-lives (whichever is shorter) prior to start of study treatment","Treatment with investigational therapy within 28 days prior to initiation of study treatment","Pregnant or breastfeeding, or intending to become pregnant during the study","History of or concurrent serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study or confounds the ability to interpret data from the study","Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety","Incomplete recovery from any surgery prior to the start of study treatment that would interfere with the determination of safety or how well it works of study treatment"],"whatHappens":"If you join, the listed intervention(s) are Inavolisib, Bevacizumab, or Cetuximab. The registry lists allocation as randomized. This open-label, exploratory study is designed to measure the safety and how well it works of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 542 people at 84 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.077Z"},{"nctId":"NCT04951804","title":"EUS-CPN With and Without Bupivacaine","officialTitle":"A Randomized Controlled Trial of Endoscopic Ultrasound Guided Celiac Plexus Neurolysis (EUS-CPN) With and Without Bupivacaine","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","sponsorClass":"OTHER","summary":"Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer.\n\nIt is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure. However, there are no data showing whether bupivacaine injection has any real influence on intra-procedural, immediate post-procedural, or long-term pain control. The injection of bupivacaine before the alcohol may have no effect, a synergistic effect, or an antagonistic effect, by diluting the alcohol, and reducing its neurolytic capacity. Inadvertent intravascular injection of bupivacaine may also cause irreversible cardiac arrhythmias and death.\n\nThe investigators therefore propose a randomized clinical trial to determine whether the exclusion of bupivacaine during EUS-guided CPN improves outcomes, or not.","conditions":["Pancreatic Cancer"],"keywords":["Pancreatic Cancer","Celiac plexus neurolysis","Bupivacaine","Endoscopic ultrasound","With Bupivacaine","Without Bupivacaine"],"interventions":[{"type":"PROCEDURE","name":"EUS-CPN without bupivacaine"},{"type":"PROCEDURE","name":"EUS-CPN with bupivacaine"}],"enrollment":180,"startDate":"2021-10-07","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail\n2. Any level of abdominal or back pain considered to be potentially related to the mass:\n\n   1. New onset pain (\\<3 months)\n   2. Constant\n   3. Centrally located\n   4. With or without irradiation to the back\n   5. No obvious other source of pain based on history and physical examination by the attending endosonographer\n3. No possibility of surgical management\n4. Signed, informed consent\n5. Celiac axis accessible for bilateral neurolysis at EUS.\n\nExclusion Criteria:\n\n1\\. Allergy to bupivacaine","locations":[{"facility":"Centre de recherche du Centre hospitalier de l'Université de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"CHARLES MACKAY, RN","phone":"514-890-8000","email":"charles.mackay.chum@ssss.gouv.qc.ca"}],"primaryOutcomes":["Change in Likert pain scores"],"hasResults":false,"conditionSlugs":["pancreatic-cancer","als"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: EUS-CPN without bupivacaine for Pancreatic Cancer","inPlainEnglish":"Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer. It is standard procedure to inject bupivacaine immediately before injecting absolute alcohol, to theoretically prevent pain that may occur during and after the procedure.","whoItsFor":["Ages 18 Years to any","Malignant-appearing pancreatic mass, or proven pancreatic cancer involving the pancreatic genu, body, or tail","Any level of abdominal or back pain considered to be potentially related to the mass:","New onset pain (\\<3 months)","With or without irradiation to the back","No obvious other source of pain based on history and physical examination by the attending endosonographer","No possibility of surgical management","Celiac axis accessible for bilateral neurolysis at EUS"],"whoShouldSkip":["1\\. Allergy to bupivacaine"],"whatHappens":"If you join, the listed intervention(s) are EUS-CPN without bupivacaine, or EUS-CPN with bupivacaine. The registry lists allocation as randomized. Endoscopic ultrasound (EUS) allows EUS-guided trans gastric injection of absolute alcohol around the base of the celiac plexus (celiac plexus neurolysis (EUS-CPN)), to help alleviate pain associated with pancreatic cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 180 people at Montreal. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.435Z"},{"nctId":"NCT04959175","title":"Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies","officialTitle":"Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nCertain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD). The chemotherapy drug cyclophosphamide helps reduce the risk and severity of GVHD. Researchers want to learn if using a lower dose of cyclophosphamide may reduce the drug's side effects while maintaining its effectiveness. Such an approach is being used in an ongoing clinical study at the NIH with promising results, but this approach has not been tested for transplants using lower doses of chemotherapy/radiation prior to the transplant.\n\nObjective:\n\nTo learn if using a lower dose of cyclophosphamide will help people have a successful transplant and have fewer problems and side effects.\n\nEligibility:\n\nAdults ages 18-85 who have a blood cancer that did not respond well to standard treatments or is at high risk for relapse without transplant, and their donors.\n\nDesign:\n\nParticipants may be screened with the following:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests\n\nHeart and lung tests\n\nBody imaging scans (they may get a contrast agent)\n\nSpinal tap\n\nBone marrow biopsy\n\nParticipants will be hospitalized for 4-6 weeks. They will have a central venous catheter placed in a chest or neck vein. It will be used to give medicines, transfusions, and the donor cells, and to take blood. In the week before transplant, they will get 2 chemotherapy drugs and radiation. After the transplant, they will get the study drug for 2 days. They will take other drugs for up to 2 months.\n\nParticipants must stay near NIH for 3 months after discharge for weekly study visits. Then they will have visits every 3-12 months until 5 years after transplant.\n\nParticipants and donors will give blood, bone marrow, saliva, cheek swab, urine, and stool samples for research.","conditions":["Hematologic Neoplasms"],"keywords":["myeloablative conditioning","Chronic Graft-Versus-Host Disease","hematopoietic cell transplantation","Fludarabine","TOTAL BODY IRRADIATION"],"interventions":[{"type":"DRUG","name":"Mycophenolate Mofetil"},{"type":"PROCEDURE","name":"Allogeneic HSCT"},{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Sirolimus"},{"type":"DRUG","name":"Filgrastim"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Mesna"},{"type":"PROCEDURE","name":"Total Body Irradiation (TBI)"}],"enrollment":320,"startDate":"2021-09-23","completionDate":"2027-04-27","sex":"ALL","minAge":"12 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"-INCLUSION CRITERIA - Recipient\n\n1. Subjects must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:\n\n   * Acute myeloid leukemia in morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n   * B-cell acute lymphoblastic leukemia in first or subsequent complete remission\n   * T-cell acute lymphoblastic leukemia in first or subsequent complete remission\n   * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n   * Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS\n   * Chronic myelomonocytic leukemia\n   * Chronic myelogenous leukemia resistant to or intolerant of \\>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n   * B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy\n   * Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV or refractory or intolerant of both BTK and PI3K inhibitors\n   * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on the Prognostic Index for T-cell lymphoma (PIT) score of low-intermediate risk or higher60 or on recently published clinical practice guidelines\n   * Hematologic malignancy of dendritic cell or histiocytic cell type\n   * Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)\n2. Age 60-85 years, or age 18-60 years and unfit for myeloablative conditioning. Reasons for unfitness for myeloablative conditioning include:\n\n   * Prior myeloablative HCT\n   * Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome.\n   * Significant organ dysfunction (e.g., creatinine or liver enzymes above the upper limit of normal or EGFR \\<=70 ml/min/1.73sq.m; prior sinusoidal obstruction syndrome, hepatic fibrosis, hepatic steatosis, or nodular regenerative hyperplasia; reduced ejection fraction \\<55% or focal hypokinesis, FEV1 or adjusted DLCO \\<75% of predicted)\n   * Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \\>= 3\n   * Subject refusal of MAC (including subjects insistent on trying to maintain fertility)\n   * Pre-frail or frail by Fried s frailty phenotype\n   * Karnofsky performance score \\<80\n   * Significant life-threatening toxicities associated with prior chemotherapy\n   * Co-morbidity considered by the treating physician to be exclusionary of MAC\n3. At least one potentially suitable HLA-matched related, HLA-haploidentical first degree or collateral related, HLA-matched unrelated, or \\>=5/10 HLA-mismatched unrelated donor.\n4. Karnofsky performance score \\>=60\n5. Ability of subject to understand and the willingness to sign a written informed consent document.\n6. Adequate organ function defined as possessing all of the following:\n\n   * Cardiac ejection fraction \\>=35%;\n   * Forced expiratory volume-1, forced vital capacity, and diffusing capacity of the lung for carbon monoxide (corrected for hemoglobin) all of \\>=40% predicted;\n   * Serum creatinine clearance of \\>=45 ml/minute calculated using the Cockcroft-Gault equation;\n   * Total bilirubin \\<=2X the upper limit of normal;\n   * Alanine aminotransferase and aspartate aminotransferase \\<=5X the upper limit of normal.\n7. Nonmyeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:\n\n   * Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal , IUD, surgical, and/or barrier method of birth control; abstinence) prior to study entry and for at least one year post-transplant.\n   * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n   * WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n8. For NIH treated subjects only: subjects requiring standard therapies to prepare for HCT should be referred in remission, if possible. However, these diseases are often aggressive and require swift evaluation for HCT while concurrently attempting to establish disease control through the administration of standard therapies. If ongoing therapy for the underlying disease outside of the NIH is not in the best interest of the subject according to the clinical judgment of the NIH PI, then the subject may receive standard treatment for his/her underlying hematologic malignancy as a bridge to HCT on this protocol, prior to starting the research phase of the study. If it becomes apparent that the subject will not be able to proceed to HCT, then he/she must come off study. Subjects receiving standard therapy will be told about the therapy, associated risks, potential benefits, alternatives to the proposed therapy, and the availability of receiving the same treatment elsewhere, outside of a research protocol.\n\nEXCLUSION CRITERIA - Recipient:\n\n1. Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.\n2. Poorly controlled malignant indication for transplantation such as:\n\n   * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5% or active extramedullary disease)\n   * Lymphoma not having achieved at least a partial response to prior chemotherapy or radiation\n3. Uncontrolled intercurrent illness that in the opinion of the site PI would make it unsafe to proceed with transplantation.\n4. The potential for some of the study medications to be transmissible via breast milk of nursing mothers is unknown. Because there is unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued.\n5. Active malignancy of non-hematopoietic type which is: metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease treated with curative intent treatment within the last 2 years. This excludes nonmelanoma skin cancers.\n\nINCLUSION CRITERIA - Donor:\n\nRelated (age \\>=12) and unrelated (age \\>=18) donors deemed eligible (i.e., evaluated at NIH in accordance with existing institutional Standard Policies and Procedures or evaluated per the standards required by the IRB of the National Marrow Donor Program or applicable registry), and willing to donate research samples will be included.\n\nEXCLUSION CRITERIA - Donor:\n\nNone","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of the University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy H Chai","phone":"(240) 858-3755","email":"amy.chai@nih.gov"},{"name":"Christopher G Kanakry, M.D.","phone":"(240) 760-6171","email":"christopher.kanakry@nih.gov"}],"primaryOutcomes":["determine if optimal dose of PTCy to prevent grade III-IV acute GVHD (aGVHD) at day +60"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["bethesda-maryland","philadelphia-pennsylvania"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Mycophenolate Mofetil for Hematologic Neoplasms","inPlainEnglish":"Background: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD).","whoItsFor":["Ages 12 Years to 85 Years","Subjects must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:","Acute myeloid leukemia in morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)","B-cell acute lymphoblastic leukemia in first or subsequent complete remission","T-cell acute lymphoblastic leukemia in first or subsequent complete remission","Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)","Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS","Chronic myelomonocytic leukemia"],"whoShouldSkip":["Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning","Poorly controlled malignant indication for transplantation such as:","Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5% or active extramedullary disease)","Lymphoma not having achieved at least a partial response to prior chemotherapy or radiation","Uncontrolled intercurrent illness that in the opinion of the site PI would make it unsafe to proceed with transplantation","The potential for some of the study medications to be transmissible via breast milk of nursing mothers is unknown. Because there is unknown but potential risk for side effects in nursing infants secondary to treatment of the mother, breastfeeding must be discontinued","who can join - Donor:"],"whatHappens":"If you join, the listed intervention(s) are Mycophenolate Mofetil, Allogeneic HSCT, or Fludarabine. The registry lists allocation as na. Background: Certain blood cancers can be treated with blood or bone marrow transplants.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 320 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.650Z"},{"nctId":"NCT04959201","title":"Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia","officialTitle":"Combination of NMDA-enhancing and Antioxidant Treatments for Schizophrenia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"China Medical University Hospital","sponsorClass":"OTHER","summary":"Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too. Whether combined treatment of an NMDA-enhancing agent and a drug with antioxidant property can be better than an NMDA-enhancing agent alone deserves study.","conditions":["Schizophrenia"],"keywords":["Schizophrenia","NMDA","Oxidative stress"],"interventions":[{"type":"DRUG","name":"NMDAE plus AO"},{"type":"DRUG","name":"NMDAE plus Placebo Cap"}],"enrollment":90,"startDate":"2020-11-30","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia\n* Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial\n* PANSS total score ≥ 60\n* Agree to participate in the study and provide informed consent\n\nExclusion Criteria:\n\n* DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder\n* History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study\n* Clinically significant laboratory screening tests (including blood routine, biochemical tests)\n* Pregnancy or lactation\n* Inability to follow protocol","locations":[{"facility":"Department of Psychiatry, China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hsien-Yuan Lane, M.D., Ph.D","phone":"886 4 22052121","email":"hylane@gmail.com"}],"primaryOutcomes":["Change of Positive and Negative Syndrome Scale (PANSS)"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["taichung-taiwan"],"enrichment":{"headline":"Phase 2: testing NMDAE plus AO for Schizophrenia","inPlainEnglish":"Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia. In addition, several drugs with antioxidant properties have been tested in clinical trials for the treatment of schizophrenia too.","whoItsFor":["Ages 18 Years to 65 Years","Have a DSM-5 (American Psychiatric Association) diagnosis of schizophrenia","Remain symptomatic but without clinically significant fluctuation, while their antipsychotic doses are unchanged for at least 3 months and will be maintained during the period of the 12-week trial","PANSS total score ≥ 60"],"whoShouldSkip":["DSM-5 diagnosis of intellectual disability or substance (including alcohol) use disorder","History of epilepsy, head trauma, stroke, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study","Clinically significant laboratory screening tests (including blood routine, biochemical tests)","Pregnancy or lactation","Inability to follow protocol"],"whatHappens":"If you join, the listed intervention(s) are NMDAE plus AO, or NMDAE plus Placebo Cap. The registry lists allocation as randomized. Previous studies found that some NMDA-enhancing agents were able to improve clinical symptoms of patients with schizophrenia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at Taichung. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.048Z"},{"nctId":"NCT04965675","title":"A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine","officialTitle":"Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"H. Lundbeck A/S","sponsorClass":"INDUSTRY","summary":"To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.","conditions":["Chronic Migraine in Children"],"keywords":[],"interventions":[{"type":"DRUG","name":"Eptinezumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":285,"startDate":"2021-06-30","completionDate":"2027-03-26","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.\n* During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit.\n* During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.\n\nExclusion Criteria:\n\n* The participant has previously been randomised in this study and exposed to eptinezumab.\n* The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \\<6 months prior to the screening visit.\n* The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \\<6 months prior to the screening visit.\n* The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration; for example \\>60 minutes).","locations":[{"facility":"Yale-New Haven Children's Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"New England Institute for Clinical Research (NEICR) - Stamford","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's National Hospital - Children's National Heart Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sarkis Clinical Trials - Gainsville","city":"Gainesville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"NW FL Clinical Research Group, LLC","city":"Gulf Breeze","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AGA Clinical Trials","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axcess Medical Research - Loxahatchee","city":"Loxahatchee Groves","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of South Florida (USF) - Tampa Campus","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta (CIRCAtl)","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UK HealthCare-Kentucky Clinic","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland-Marlene and Stewart Greenebaum Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Michigan Headache & Neurological Institute (MHNI)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Corewell Health - Butterworth Hospital","city":"Grand Rapids","state":"Michigan","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Dent Neurosciences Research Center","city":"Amherst","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"True North Neurology - 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Lundbeck A/S","phone":"+45 36301311","email":"HQ_Medinfo@Lundbeck.com"}],"primaryOutcomes":["Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","stamford-connecticut","washington-d-c-district-of-columbia","gainesville-florida","gulf-breeze-florida","hialeah-florida","loxahatchee-groves-florida","tampa-florida","atlanta-georgia","lexington-kentucky","baltimore-maryland","ann-arbor-michigan","grand-rapids-michigan","amherst-new-york","commack-new-york","charlotte-north-carolina","cincinnati-ohio","oklahoma-city-oklahoma","san-antonio-texas","norfolk-virginia","tacoma-washington","huntington-west-virginia","mar-del-plata-argentina","buenos-aires-argentina","c-rdoba-argentina","r-o-cuarto-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","edmonton-canada","penticton-canada","victoria-canada","ajax-canada","london-canada","cagliari-italy","genoa-italy","milan-italy","pavia-italy","rome-italy","durango-mexico","guadalajara-mexico","zapopan-mexico","morelia-mexico","monterrey-mexico","culiac-n-mexico","m-xico-mexico","chihuahua-city-mexico","tepetlacolco-mexico","krakow-poland","o-wi-cim-poland","lublin-poland","warsaw-poland","almada-portugal","coimbra-portugal","porto-portugal","belgrade-serbia","novi-sad-serbia","kragujevac-serbia","seville-spain","barcelona-spain","madrid-spain","fatih-turkey-t-rkiye","eski-ehir-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","mersin-turkey-t-rkiye","exeter-united-kingdom","edinburgh-united-kingdom","great-yarmouth-united-kingdom","glasgow-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Eptinezumab for Chronic Migraine in Children","inPlainEnglish":"To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.","whoItsFor":["Ages 12 Years to 17 Years","The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit","During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 23 of the 28 days following the screening visit","During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary"],"whoShouldSkip":["The participant has previously been randomly assigned in this study and exposed to eptinezumab","The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) \\<6 months prior to the screening visit","The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) \\<6 months prior to the screening visit"],"whatHappens":"If you join, the listed intervention(s) are Eptinezumab, or Placebo. The registry lists allocation as randomized. To find out if eptinezumab is better than dummy treatment (placebo) (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 285 people at 76 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.303Z"},{"nctId":"NCT04966481","title":"Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor","officialTitle":"Palbociclib and Cetuximab Versus Cetuximab Monotherapy for Patients With CDKN2A-altered, HPV-unrelated Head and Neck Squamous Cell Carcinoma Who Experienced Disease Progression on a PD-1/L1 Inhibitor: A Multicenter, Open-Label, Randomized Phase 3 Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"This multicenter, open-label, randomized phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab monotherapy (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as monotherapy or in combination with other therapy).","conditions":["HPV-unrelated Head and Neck Squamous Cell Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Cetuximab"}],"enrollment":81,"startDate":"2022-04-06","completionDate":"2029-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed RM-HNSCC that is HPV-unrelated disease; defined as SCC of the oral cavity, larynx, or hypopharynx and p16 negative SCC of the oropharynx or p16 negative non-cutaneous SCC unknown primary of the neck.\n* CDKN2A loss-of-function (LOF) alteration: mutation or homozygous deletion described on genomic sequencing report.\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam, per RECIST 1.1.\n* Disease progression on a PD-1/L1 inhibitor-containing regimen (given as monotherapy or in combination with other therapy).\n* Received no more than three lines of prior therapy for RM-HNSCC.\n* At least 18 years of age.\n* ECOG performance status ≤ 1.\n* Normal bone marrow and organ function as defined below:\n\n  * Hemoglobin ≥ 8 g/L\n  * Absolute neutrophil count ≥ 1,000/mcl\n  * Platelets ≥ 100,000/mcl\n  * Total bilirubin ≤ 3 x institutional upper limit of normal (IULN)\n  * AST(SGOT)/ALT(SGPT) ≤ 5 x IULN (for cases involving liver metastases, AST/ALT ≤ 10 x IULN)\n  * Serum creatinine \\< 3 x IULN or creatinine clearance \\> 30 mL/min by Cockcroft-Gault\n* The effects of palbociclib and cetuximab on the developing human fetus are unknown. For this reason and because CDK 4/6 inhibitors are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 3 months days after completion of the study\n* Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior treatment with cetuximab for recurrent or metastatic disease (however, prior cetuximab given as a component of multimodality therapy for newly diagnosed, locally advanced, non-metastatic HNSCC is allowable).\n* Prior treatment with a CDK4/6 inhibitor for RM-HNSCC.\n* Rb (retinoblastoma) loss: mutation or homozygous deletion described on genomic sequencing report.\n* Currently receiving any other investigational agents.\n* A history of other malignancy with the exception of malignancies for which all treatment was completed at least 1 year before registration and the patient has no evidence of recurrent/persistent disease.\n* Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study (excluding cetuximab).\n* Prior grade 3 or 4 (per CTCAE 5.0) hypersensitivity reaction to cetuximab.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active serious infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n* QTc \\>500 msec (using Bazette formula).\n* Patients with HIV are eligible unless their CD4+ T-cell counts are \\< 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated).","locations":[{"facility":"Sanford Worthington Medical Center","city":"Worthington","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Roger Maris Cancer Center","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Medical Center","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Douglas Adkins, M.D.","phone":"314-747-8475","email":"dadkins@wustl.edu"}],"primaryOutcomes":["Overall survival (OS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["palbociclib"],"locationSlugs":["worthington-minnesota","kansas-city-missouri","st-louis-missouri","fargo-north-dakota","sioux-falls-south-dakota"],"enrichment":{"headline":"Phase 3: testing Palbociclib for HPV-unrelated Head and Neck Squamous Cell Carcinoma","inPlainEnglish":"This multicenter, open-label, randomly assigned phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab this drug alone (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as this drug alone or in combination with other therapy).","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed RM-HNSCC that is HPV-unrelated disease; defined as SCC of the oral cavity, larynx, or hypopharynx and p16 negative SCC of the oropharynx or p16 negative non-cutaneous SCC unknown primary of the neck","CDKN2A loss-of-function (LOF) alteration: mutation or homozygous deletion described on genomic sequencing report","Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by chest x-ray, or ≥ 10 mm with calipers by clinical exam, per RECIST 1.1","Disease progression on a PD-1/L1 inhibitor-containing regimen (given as this drug alone or in combination with other therapy)","Received no more than three lines of prior therapy for RM-HNSCC","At least 18 years of age","how well you can do daily activities (ECOG score) ≤ 1"],"whoShouldSkip":["Prior treatment with cetuximab for recurrent or metastatic disease (however, prior cetuximab given as a component of multimodality therapy for newly diagnosed, locally advanced, non-metastatic HNSCC is allowable)","Prior treatment with a CDK4/6 inhibitor for RM-HNSCC","Rb (retinoblastoma) loss: mutation or homozygous deletion described on genomic sequencing report","Currently receiving any other investigational agents","A history of other malignancy with the exception of malignancies for which all treatment was completed at least 1 year before registration and the patient has no evidence of recurrent/persistent disease","Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to palbociclib or other agents used in the study (excluding cetuximab)"],"whatHappens":"If you join, the listed intervention(s) are Palbociclib, or Cetuximab. The registry lists allocation as randomized. This multicenter, open-label, randomly assigned phase 3 trial will determine if palbociclib and cetuximab (Arm 1) improves overall survival (OS) in comparison to cetuximab this drug alone (Arm 2) in patients with CDKN2A-altered, HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who experienced disease progression on a PD-1/L1 inhibitor (given as this drug alone or in combination with other therapy).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 81 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.724Z"},{"nctId":"NCT04971564","title":"Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia","officialTitle":"Thrombo-inflammation Biomarkers Trial in Acute Cerebral Hypoxia. A Case-control Trial Nested in a Cohort","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fondation Ophtalmologique Adolphe de Rothschild","sponsorClass":"NETWORK","summary":"The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.","conditions":["Cerebral Hypoxia","Ischemic Stroke"],"keywords":[],"interventions":[{"type":"OTHER","name":"Blood sampling"}],"enrollment":200,"startDate":"2024-03-19","completionDate":"2028-06-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- For cases, admitted within the first 36 hours of an acute neurological symptom related to :\n\n* An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,\n* A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,\n* An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \\>4.\n\nOR\n\n* For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score.\n* Express consent to participate in the study.\n* Member or beneficiary of a social security.\n\nExclusion Criteria:\n\n* Pre-existing functional and/or cognitive disability\n* Patient under legal protection.\n* Pregnant or breastfeeding woman.\n* Patient with secondary haemorrhagic transformation.\n\nSecondary exclusion criteria :\n\n* Patients with an ischaemic lesion visible on imaging, unrelated to large vessel occlusion and therefore ineligible for mechanical thrombectomy.\n* Patients diagnosed with an acute non-vascular neurological pathology (migraine, epilepsy, etc.).\n* TIA patients presenting an abnormality on follow-up imaging 24-48 hours after the initial imaging.\n\nExcluded patients will be replaced.","locations":[{"facility":"Hôpital Fondation Adolphe de Rothschild","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"François DELVOYE","phone":"0148036556","email":"fdelvoye@for.paris"},{"name":"Amélie Yavchitz","phone":"0148036556","email":"fyavchitz@for.paris"}],"primaryOutcomes":["Biomarker rates at day 0"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: Blood sampling for Cerebral Hypoxia","inPlainEnglish":"The goal of this trial is to study, in three well-defined clinical situations responsible for cerebral hypoxia, the concentrations of biomarkers of thrombo-inflammation compared to a population of patients without cerebral hypoxia, and to study in patients with cerebral hypoxia the association between these concentrations and the clinical evolution.","whoItsFor":["Ages 18 Years to any","\\- For cases, admitted within the first 36 hours of an acute neurological symptom related to :","An ischaemic cerebrovascular accident (iCVA) eligible for a mechanical thrombectomy procedure,","A subarachnoid haemorrhage (SAH, all aetiologies) : patient presenting with at least a modified Fisher scale 3 or 4,","An intra-parenchymal haematoma (IPH) with greatest axis ≥ 20mm or with NIHSS on admission \\>4","For control patients, admitted within 7 days of the onset of acute neurological symptomatology related to a clinical diagnosis of transient ischaemic attack (TIA) - based on thorough questioning of the patient on admission - and prior to imaging, with an ABCD2≥ 2 score","Express consent to participate in the study","Member or beneficiary of a social security"],"whoShouldSkip":["Pre-existing functional and/or cognitive disability","Patient under legal protection","Pregnant or breastfeeding woman","Patient with secondary haemorrhagic transformation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Paris. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.223Z"},{"nctId":"NCT04978571","title":"Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)","officialTitle":"A Prospective Study on the Effect of Auricular Percutaneous Electrical Nerve Field Stimulation (PENFS) in Patients With Post Concussion Syndrome (PCS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Children's Hospital of Orange County","sponsorClass":"OTHER","summary":"The purpose of this study is to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms.\n\nAn additional purpose of this study is to demonstrate that PENFS improves functioning in children with post Covid-19 symptoms.","conditions":["Post-Concussion Syndrome","COVID Long-Haul","COVID-19"],"keywords":[],"interventions":[{"type":"DEVICE","name":"percutaneous electrical nerve-field stimulation, PENFS"},{"type":"DEVICE","name":"percutaneous electrical nerve-field stimulation, PENFS (sham device)"},{"type":"DEVICE","name":"percutaneous electrical nerve-field stimulation, PENFS (COVID active device)"}],"enrollment":125,"startDate":"2021-02-01","completionDate":"2026-12","sex":"ALL","minAge":"11 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Concussion:\n\nInclusion Criteria:\n\n* Clinical diagnosis of Post-Concussion Syndrome\n* Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms\n* English and Spanish-speaking families\n\nExclusion Criteria:\n\n* Seizure disorders\n* Significant developmental delay\n* Infection or severe dermatological condition of ear\n* Bleeding disorders\n* Implanted electrical device\n\nCOVID:\n\nInclusion Criteria\n\n* Child is in between the ages 11-18\n* Child is present at CHOC Neurology clinic post covid-19 symptoms of more than 3 months duration along with lack of other explanation for their symptoms\n* English-speaking and Spanish-speaking families\n\nYou cannot participate in this study if you meet the following exclusion criteria:\n\n* Children with significant developmental delay, infection or severe dermatological condition of ear, bleeding disorders, or having any implanted electrical device will be excluded.\n* Are not able to attend Friday appointments for the Neurostim placements.","locations":[{"facility":"CHOC Children's","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pari Mokhtari","phone":"714-509-8765","email":"pari.mokhtari@choc.org"},{"name":"Gabriela Velazquez","phone":"714-509-8765","email":"gabriela.velazquez@choc.org"}],"primaryOutcomes":["Immediate Post-Concussion Assessment","Post-Concussion Symptom Scale","Balance Error Scoring Symptom","COGNIGRAM"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["orange-california"],"enrichment":{"headline":"Not a traditional drug phase: percutaneous electrical nerve-field stimulation, PENFS for Post-Concussion Syndrome","inPlainEnglish":"This study wants to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms. An additional purpose of this study is to demonstrate that PENFS improves functioning in children with post Covid-19 symptoms.","whoItsFor":["Ages 11 Years to 18 Years","Clinical diagnosis of Post-Concussion Syndrome","Post-Concussion Symptoms for at least 3 months along with lack of other explanation for their symptoms","English and Spanish-speaking families"],"whoShouldSkip":["Significant developmental delay","Infection or severe dermatological condition of ear","Implanted electrical device","Child is in between the ages 11-18","Child is present at CHOC Neurology clinic post covid-19 symptoms of more than 3 months duration along with lack of other explanation for their symptoms","English-speaking and Spanish-speaking families","You cannot participate in this study if you meet the following"],"whatHappens":"If you join, the listed intervention(s) are percutaneous electrical nerve-field stimulation, PENFS, percutaneous electrical nerve-field stimulation, PENFS (sham device), or percutaneous electrical nerve-field stimulation, PENFS (COVID active device). The registry lists allocation as randomized. This study wants to test the effect of Auricular Percutaneous Electrical Nerve Field Stimulation (a Neurostim device) on children with pain and Post Concussion symptoms.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 125 people at Orange. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.232Z"},{"nctId":"NCT04979728","title":"HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots","officialTitle":"HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots (HOME-1)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"The goal of this observational study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements.\n\nParticipants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year. The investigators will compare drug concentrations of antivirals and relevant metabolites/anabolites in clinic-collected and self-collected blood samples.","conditions":["HIV Treatment","HIV Prevention"],"keywords":["antivirals","ART","PrEP","long-acting","cabotegravir","rilpivirine","tenofovir","lenacapavir","self-collections","self-collected blood samples","drug concentrations"],"interventions":[{"type":"OTHER","name":"At Home Self-Collections"}],"enrollment":150,"startDate":"2021-05-27","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* ≥18 years old\n* Receiving one or more antivirals for HIV treatment or prevention. This may include TFV (as TDF or TAF) and FTC (or 3TC)-based, LA (e.g., LA IM CAB±RPV Q4W or Q8W), or other antivirals (those who are transitioning to LA antivirals \\[e.g., LA IM CAB±RPV Q4W or Q8W\\] will also be eligible)\n* Current patient at the UCH-IDGP clinic\n* Able to comply with study procedures, including directly observed self-collection of DBS by fingerstick, Tasso-M20/Tasso+, Mitra, and/or other self-collection methods/devices, and completion of survey\n\nExclusion criteria:\n\n* Inability to provide informed consent\n* Unable or unwilling to comply with directly observed self-collection of DBS (e.g., unavailable or unable to use live video-streaming or time-stamped video recording technology)\n* Any uncontrolled medical, social, or mental health issue(s) that, in the opinion of the investigators, could interfere with the study participation or study outcomes (e.g., current incarceration)\n* Any medical condition that, in the opinion of the study team, acutely and/or transiently influences the PK of CAB±RPV, including acute kidney injury, hepatic insufficiency, significant drug-drug interactions, active hemolysis or symptomatic hemoglobinopathies, etc. (Note: Given the need for PK data in pregnancy, women who become pregnant while on LA IM CAB±RPV Q4W or Q8W will be allowed to participate in this study, if their clinical provider decides to continue this regimen.)","locations":[{"facility":"University of Colorado Hospital (UCHealth)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ryan Coyle, MPH","phone":"720-695-8020","email":"ryan.coyle@cuanschutz.edu"}],"primaryOutcomes":["Agreement of drug concentrations of antivirals and relevant metabolites/anabolites in blood samples"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["aurora-colorado"],"enrichment":{"headline":"Not a traditional drug phase: At Home Self-Collections for HIV Treatment","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to establish an operational framework for home self-collections of blood samples to be used for antiviral drug concentration measurements. Participants will continue on their prescribed antiviral(s) for HIV treatment or prevention and followed for up to approximately 1 year.","whoItsFor":["Ages 18 Years to any","Current patient at the UCH-IDGP clinic","Able to comply with study procedures, including directly observed self-collection of DBS by fingerstick, Tasso-M20/Tasso+, Mitra, and/or other self-collection methods/devices, and completion of survey"],"whoShouldSkip":["Any uncontrolled medical, social, or mental health issue(s) that, in the opinion of the investigators, could interfere with the study participation or study outcomes (e.g., current incarceration)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Aurora. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.401Z"},{"nctId":"NCT04986657","title":"Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS","officialTitle":"A Prospective Study of Whole Genome Sequencing (ChromoSeq) as an Adjunct to Conventional Genomic Profiling in AML and MDS","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).","conditions":["Whole Genome Sequencing","Acute Myeloid Leukemia","Myelodysplastic Syndromes"],"keywords":[],"interventions":[{"type":"DEVICE","name":"ChromoSeq"}],"enrollment":375,"startDate":"2021-09-17","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria Patient\n\n* Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested.\n* Adult patients 18 years or older.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nInclusion Criteria Physician\n\n* Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies.\n* Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process.\n\nExclusion Criteria Patient\n\n* Younger than 18 years of age\n\nExclusion Criteria Physician\n\n* Does not treat patients at Washington University School of Medicine","locations":[{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meagan Jacoby, M.D., Ph.D.","phone":"314-747-8439","email":"mjacoby@wustl.edu"}],"primaryOutcomes":["Sensitivity of ChromoSeq as measured by total number of recurrent structural variants identified","Sensitivity of ChromoSeq as measured by total number of copy number alterations identified","Sensitivity of ChromoSeq as measured by number of single nucleotide variants identified","Sensitivity of ChromoSeq as measured by number of insertion-deletions identified","Determine if risk-stratification using ChromoSeq correlates with overall-survival","Determine if risk-stratification using ChromoSeq correlates with event-free survival","Proportion of cases in which ChromoSeq provides new genetic information to the clinician","ChromoSeq turnaround time","Proportion of failed ChromoSeq assays"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: ChromoSeq for Whole Genome Sequencing","inPlainEnglish":"This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq. Using prospectively collected patient data, coupled with physician surveys, the investigators seek to determine the feasibility of implementing ChromoSeq in addition to standard genomic testing, for patients with the diagnoses of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).","whoItsFor":["Ages 18 Years to any","Patient with a clinical suspicion for a new diagnosis of AML or MDS for whom the diagnostic molecular testing via the hematologic molecular algorithm (HMA) at BJH is requested or planned to be requested","Adult patients 18 years or older","who can join Physician","Treating physician at Washington University School of Medicine who directs therapy for individuals with hematologic malignancies","Able and willing to complete standardized questionnaires about usability, and stakeholder perceptions of ChromoSeq during the ChromoSeq implementation process"],"whoShouldSkip":["Younger than 18 years of age"],"whatHappens":"If you join, the listed intervention(s) are ChromoSeq. The registry lists allocation as randomized. This is a single institution, prospective study of the whole genome sequencing assay, ChromoSeq.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 375 people at St Louis. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.819Z"},{"nctId":"NCT05000996","title":"Gut Microbiota in Metabolic Surgery","officialTitle":"The Gut Microbiota in Metabolic Surgery: A Multi-Ethnic, Multi-Omic, Longitudinal Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Vanderbilt University Medical Center","sponsorClass":"OTHER","summary":"Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.","conditions":["Bariatric Surgery Candidate","Cardiovascular Diseases","Type 2 Diabetes","Dyslipidemias","Hypertension","Morbid Obesity"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Bariatric Surgery"}],"enrollment":300,"startDate":"2021-08-19","completionDate":"2028-12-31","sex":"ALL","minAge":"21 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center\n* Have a history of type 2 diabetes, hypertension, or dyslipidemia\n* Be able and willing to provide personal information and biological samples needed for the study\n\nExclusion Criteria:\n\n* Prior gastric operations\n* A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis\n* Chemotherapy or radiotherapy for cancer within 2 years\n* Current inflammatory bowel disease or celiac disease\n* Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months","locations":[{"facility":"Vanderbilt_University MC","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Danxia Yu, PhD","phone":"615-936-7389","email":"danxia.yu@vumc.org"},{"name":"Charles R Flynn, PhD","phone":"615-343-8329","email":"robb.flynn@vumc.org"}],"primaryOutcomes":["Estimated 10-year risk of atherosclerotic cardiovascular disease"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity","hypertension"],"drugSlugs":[],"locationSlugs":["nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: Bariatric Surgery for Bariatric Surgery Candidate","inPlainEnglish":"Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes.","whoItsFor":["Ages 21 Years to 65 Years","Be approved and scheduled for metabolic surgery at the Vanderbilt University Medical Center","Have a history of type 2 diabetes, hypertension, or dyslipidemia","Be able and willing to provide personal information and biological samples needed for the study"],"whoShouldSkip":["Prior gastric operations","A history of coronary artery disease, stroke, heart failure, HIV infection, or untreated viral hepatitis","Chemotherapy or radiotherapy for cancer within 2 years","Current inflammatory bowel disease or celiac disease","Vomiting, constipation, or diarrhea within 7 days or use of antibiotics within 2 months"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Nashville. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.523Z"},{"nctId":"NCT05003934","title":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for RA","officialTitle":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion and Intra-Articular Injection for the Treatment of Rheumatoid Arthritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Foundation for Orthopaedics and Regenerative Medicine","sponsorClass":"OTHER","summary":"This trial will study the safety and efficacy of intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis","conditions":["Rheumatoid Arthritis"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells"}],"enrollment":20,"startDate":"2021-11-07","completionDate":"2028-09","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of Rheumatoid Arthritis\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur","locations":[{"facility":"Prodromos Stem Cell Institute","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prodromos Stem Cell Institute","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Safety (adverse events)"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["naples-florida","athens-greece"],"enrichment":{"headline":"Phase 1: testing cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for Rheumatoid Arthritis","inPlainEnglish":"This trial will study the safety and how well it works of intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis","whoItsFor":["Diagnosis of Rheumatoid Arthritis"],"whoShouldSkip":["Chronic multisystem organ failure","Clinically significant Abnormalities on pre-treatment laboratory evaluation","Medical condition that would (based on the opinion of the investigator) compromise patient's safety","Continued drug abuse","Pre-menopausal women not using contraception","Previous organ transplant","Hypersensitivity to sulfur"],"whatHappens":"If you join, the listed intervention(s) are cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells. The registry lists allocation as na. This trial will study the safety and how well it works of intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.966Z"},{"nctId":"NCT05039619","title":"A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","officialTitle":"A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\<12 with LN.","conditions":["Lupus Nephritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Obinutuzumab"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Mycophenolate Mofetil"},{"type":"DRUG","name":"Acetaminophen/paracetamol"},{"type":"DRUG","name":"Diphenhydramine hydrochloride (HCl)"},{"type":"DRUG","name":"Methylprednisolone"},{"type":"DRUG","name":"Prednisone"}],"enrollment":40,"startDate":"2022-05-12","completionDate":"2028-06-15","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who are age 12 to \\<18 years at the time of randomization\n* Participants who are age 5 to \\<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse","locations":[{"facility":"Loma Linda University health","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Benioff Childrens Hospital","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado, Anchutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Children's Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health University Hospital","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louisiana State University","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cohen Children's Medical Center of New York","city":"Queens","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Childrens Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chldren?s Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Texas Arthritis Center","city":"El Paso","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Ser Servicos Especializados Em Reumatologia","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Ensino da Saude e Gestao - IESG","city":"Salvado","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitário Onofre Lopes - UFRN","city":"Petrópolis","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisa São Lucas","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clinicas - FMUSP","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universidade Federal de Sao Paulo - UNIFES","city":"São Paulo","state":"","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sainte-Justine","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH de Bicêtre","city":"Le Kremlin-Bicêtre","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Robert Debré","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hop Necker Enfants Malades","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse - Hôpital des Enfants","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS G. Gaslini","city":"Genoa","state":"Liguria","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Pediatrica II De Marchi","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"CREA Hospital Mexico Americano","city":"Guadalajara","state":"Jalisco","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinstile S.A de C.V.","city":"Mexico City","state":"Mexico CITY (federal District)","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Dr. Jose Eleuterio Gonzalez","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Ginecología y Reproducción","city":"Lima","state":"","country":"Peru","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinica El Golf","city":"San Isidro","state":"","country":"Peru","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital Specjalistyczny dla Dzieci i Doroslych","city":"Torun","state":"","country":"Poland","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Saint-Petersburg State","city":"St-peterburg","state":"Sankt-Peterburg","country":"Russia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Red Cross War Memorial Children?s Hospital","city":"Cape Town","state":"","country":"South Africa","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Groote Schuur Hospital","city":"Cape Town","state":"","country":"South Africa","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Panaroma Medical Center","city":"Panorama","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan De Deu","city":"Esplugas de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica","city":"Valencia","state":"","country":"Spain","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Royal Hospital For Children","city":"Glasgow","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Alder Hey Childrens Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital for Children","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global.rochegenentechtrials@roche.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)","Percentage of Participants with Adverse Events (PP)"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["loma-linda-california","san-francisco-california","aurora-colorado","atlanta-georgia","indianapolis-indiana","shreveport-louisiana","hackensack-new-jersey","queens-new-york","cincinnati-ohio","philadelphia-pennsylvania","el-paso-texas","salvador-brazil","salvado-brazil","petr-polis-brazil","campinas-brazil","s-o-paulo-brazil","toronto-canada","montreal-canada","le-kremlin-bic-tre-france","paris-france","toulouse-france","rome-italy","genoa-italy","milan-italy","guadalajara-mexico","mexico-city-mexico","monterrey-mexico","lima-peru","san-isidro-peru","gdansk-poland","torun-poland","st-peterburg-russia","cape-town-south-africa","panorama-south-africa","esplugas-de-llobregat-spain","madrid-spain","valencia-spain","glasgow-united-kingdom","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Obinutuzumab for Lupus Nephritis","inPlainEnglish":"This phase II, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study is designed to measure the safety, how well it works and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\<12 with LN.","whoItsFor":["Ages 5 Years to 17 Years","Participants who are age 12 to \\<18 years at the time of randomization","Participants who are age 5 to \\<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)","International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening","Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible","Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria","Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening","During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN"],"whoShouldSkip":["Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia","Sclerosis in \\>50% of glomeruli on renal biopsy","Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions","Presence of rapidly progressive glomerulonephritis","Intolerance or contraindication to study therapies","History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders","History of serious recurrent or chronic infection"],"whatHappens":"If you join, the listed intervention(s) are Obinutuzumab, Placebo, or Mycophenolate Mofetil. The registry lists allocation as randomized. This phase II, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study is designed to measure the safety, how well it works and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.278Z"},{"nctId":"NCT05046613","title":"Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant","officialTitle":"A Prospective, Registry-based, Observational Study to Assess Maternal, Fetal and Infant Outcomes Following Exposure to Rimegepant: The Migraine Observational Nurtec Pregnancy Registry (MONITOR)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.","conditions":["Migraine"],"keywords":["Migraine, Migraine Headache, Pregnant, Pregnancy, Infant"],"interventions":[{"type":"OTHER","name":"Rimegepant"},{"type":"OTHER","name":"Not taking Rimegepant"}],"enrollment":780,"startDate":"2021-09-23","completionDate":"2029-11-04","sex":"FEMALE","minAge":"0 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)\n* Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy\n\nExclusion Criteria:\n\n• Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy","locations":[{"facility":"Evidera, a PPD business unit","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Major congenital malformation (birth defect)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["wilmington-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Rimegepant for Migraine","inPlainEnglish":"The purpose of the study is to evaluate fetal, maternal, and infant outcomes through 12 months of age.","whoItsFor":["Ages 0 Years to any","Women only","Pregnant women with migraine exposed to rimegepant: a diagnosis of migraine and at least 1 dose of rimegepant during pregnancy or just prior to pregnancy (up to 3 days prior to conception)","Pregnant women with migraine unexposed to rimegepant: a diagnosis of migraine and no exposure to Rimegepant before or during pregnancy"],"whoShouldSkip":["Women exposed to other calcitonin gene-related peptide (CGRP)antagonists (e.g., ubrogepant), CGRP monoclonal antibodies, or ditans (e.g., lasmiditan) at any time during pregnancy or just prior to pregnancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 780 people at Wilmington. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.297Z"},{"nctId":"NCT05051722","title":"Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer","officialTitle":"Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer: a Phase II Clinical Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma.\n\nThis proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.","conditions":["Endometrial Cancer","Cervical Cancer","Atypical Endometrial Hyperplasia","Cervical Dysplasia","Adnexal Mass","Ovarian Cancer"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Vaginal Fluid Collection"},{"type":"DIAGNOSTIC_TEST","name":"Blood Collection"}],"enrollment":3110,"startDate":"2021-08-03","completionDate":"2027-07-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for Cohort 1:\n\nPatients will be ≥45 years of age and meet one of the following criteria:\n\n* Abnormal uterine bleeding\n* Postmenopausal bleeding\n\nOR\n\nPatients ages 18 - 44 years of age and meet these criteria\n\n* Abnormal uterine bleeding\n* One risk factor for endometrial cancer (BMI ≥30 or PCOS or Tamoxifen use)\n\nExclusion Criteria for Cohort 1:\n\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia\n* Current biopsy-proven endometrial cancer or endometrial hyperplasia\n* Current biopsy-proven benign endometrial polyp\n* Endometrial biopsy/sampling within the preceding 1 month showing benign endometrium\n\nInclusion Criteria for Cohort 2:\n\nPatients will be ≥18 years of age and meet at least one of the following criteria:\n\n* Presence of biopsy-proven EC (any histology, including uterine carcinosarcoma) and surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection\n* Biopsy showing AEH or EIN with surgical intervention planned. Surgical intervention can include any of the following: hysterectomy, D\\&C, hysteroscopic resection, etc)\n\nExclusion Criteria for Cohort 2:\n\n* Undergoing surgical procedure for recurrent or metastatic EC\n* Received preoperative neoadjuvant chemotherapy or radiotherapy for current EC diagnosis\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven cervical cancer\n* Presence of concomitant biopsy-proven cervical dysplasia\n* Any prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Prior intervention or surgery with intent to completely remove the target pathology\n\nInclusion Criteria for Cohort 3:\n\nPatients will be ≥18 years of age, have a cervix and meet at least one of the following criteria:\n\n* History of current abnormal cervical/endocervical Pap test for which the patient is presenting for colposcopy\n* Cervical mass identified on physical exam and patient referred for cervical biopsy, even if colposcopy not recommended or indicated\n* Planned clinically indicated surgical excisional biopsy or removal of the cervix (cold knife cone, LEEP, hysterectomy) for abnormal Pap test, cervical dysplasia, cervical mass, or biopsy-proven invasive cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, or less common primary cervical carcinomas all eligible)\n\nExclusion Criteria for Cohort 3:\n\n* History of pelvic or vaginal radiotherapy\n* Prior total hysterectomy (cervix removed) for any indication\n* Current known pregnancy diagnosis\n* Cervical mass biopsy-proven to be EC or a cancer metastatic from a non-cervical origin\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Patients presenting for colposcopy as part of lower genital tract dysplasia or cancer surveillance after prior curative intent treatment and no current Pap abnormality or cervical mass\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode\n\nInclusion Criteria for Cohort 4:\n\nPatients will be ≥45 years of age and should meet at least one of the following criteria:\n\n* Undergoing hysterectomy with biopsy-proven or clinically presumed (based on imaging and/or clinical symptoms) benign gynecologic or uterine pathology of fibroids, endometriosis, adenomyosis, or benign endometrial polyps.\n* Undergoing any gynecologic surgery in which a benign pathologic tissue diagnosis of fibroids, endometriosis, adenomyosis, or benign endometrial polyp is anticipated to be confirmed.\n\nExclusion Criteria for Cohort 4:\n\n* Endometrial biopsy or office hysteroscopy within 2 weeks preceding the planned gynecologic surgery procedure for fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Undergoing hysterectomy for prolapse without a coexisting known or presumed benign uterine pathologic diagnosis of fibroids, endometriosis, benign endometrial polyps, or adenomyosis\n* Prior intervention or surgery with intent to completely remove the target pathology for the current lesion / diagnosis during the current episode\n\nInclusion Criteria for Cohort 5:\n\nPatients with a uterus will be ≥45 years of age and should meet the following criteria:\n\n* Presenting for GYN wellness exam, ± Pap test\n* No change in medical conditions, new diagnoses, or new medications within the past 6 months\n\nExclusion Criteria for Cohort 5:\n\n* Pap test or cervical biopsy within the past 1 month\n* Endometrial biopsy or office hysteroscopy within the past 1 month\n* Any surgery within the past 3 months\n* Prior hysterectomy\n* Current known pregnancy diagnosis\n* Prior or current biopsy-proven gynecologic cancer\n* Current biopsy-proven AEH/EIN, cervical, vaginal, or vulvar dysplasia\n* Prior pelvic or vaginal radiotherapy\n* Any prior cancer (except basal cell skin cancer) within the past 5 years\n* Chemotherapy within the past 5 years\n* Criteria met for inclusion in any of the other study cohorts\n\nInclusion Criteria for Cohort 6:\n\nPatients ≥50 years of age and:\n\n* Postmenopausal\n* At least 1 intact ovary\n* Diagnosis of an adnexal mass or a clinical suspicion of early-stage ovarian cancer (including fallopian tube cancer)\n* Planned surgery for the adnexal mass\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation/occlusion)\n\nExclusion criteria for Cohort 6:\n\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn)\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* Clinically suspected advanced stage ovarian cancer (Stage III or IV) on presentation, if known prior to specimen collection\n* Surgical candidates for recurrent ovarian cancer\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n\nInclusion criteria for Cohort 7:\n\nWomen will be ≥18 years of age and meet the following criteria:\n\n* Presence of clinically probable ovarian, fallopian tube, or primary peritoneal cancer (all under the umbrella of OC) based on clinical findings of any/all of the following: imaging showing adnexal and/or abdominal masses consistent with probable ovarian cancer, omental caking, elevated CA125, ascites, imaging-guided biopsy consistent with OC pathology\n* Newly diagnosed with ovarian, fallopian tube or primary peritoneal cancer without neoadjuvant therapy\n* At least one intact ovary\n* For vaginal fluid collection, patient must have a uterus, cervix and at least 1 intact fallopian tube\\* (without prior tubal ligation/occlusion)\n\nExclusion criteria for Cohort 7:\n\n* Patients with recurrent OC\n* Any current or prior cancer diagnosis (except basal cell or squamous cell skin cancer, non-gyn) within the past 5 years\n* Chemotherapy for cancer treatment within the past 5 years prior to collection\n* History of pelvic or vaginal radiation therapy\n* Known current synchronous endometrial cancer or hyperplasia\n* Known current cervical, vaginal, or vulvar dysplasia\n* Current known pregnancy diagnosis","locations":[{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"My GYN Care","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Genoma Research, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Signature Women's Healthcare, LLC","city":"Pembroke Pines","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sarasota Memorial Health Care System","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providea Health Partners, LLC","city":"Evergreen Park","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Clinic Foundation","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley OB-GYN Clinic","city":"Saginaw","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Mississippi Medical Center","city":"Jackson","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Woman's Health Pavilion","city":"Howard Beach","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Woman's Health Pavilion","city":"Westbury","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altru Health System","city":"Grand Forks","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Total Women's Care of the Heights","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Colleagues of Texas, LLP","city":"Katy","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University/ Massey Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System - Northwest Wisconsin","city":"Eau Claire","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System - Southwest Wisconsin","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maureen A Lemens, BSN","phone":"507-293-1487","email":"lemens.maureen@mayo.edu"},{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Develop predictive models from a panel of EC-specific MDMs and validate their performance in identifying underlying EC and AEH within vaginal fluid in a larger, more diverse cohort.","Develop predictive models from a panel of OC-specific MDMs and validate their performance in identifying underlying OC within vaginal fluid and plasma in a larger, more diverse cohort."],"hasResults":false,"conditionSlugs":["ovarian-cancer","cervical-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","jacksonville-florida","miami-florida","orlando-florida","pembroke-pines-florida","sarasota-florida","atlanta-georgia","chicago-illinois","evergreen-park-illinois","new-orleans-louisiana","detroit-michigan","saginaw-michigan","rochester-minnesota","jackson-mississippi","howard-beach-new-york","westbury-new-york","grand-forks-north-dakota","cleveland-ohio","houston-texas","katy-texas","richmond-virginia","eau-claire-wisconsin","la-crosse-wisconsin","milwaukee-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Vaginal Fluid Collection for Endometrial Cancer","inPlainEnglish":"The overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid.","whoItsFor":["Ages 18 Years to any","Women only","Patients will be ≥45 years of age and meet one of the following criteria:","Abnormal uterine bleeding","Postmenopausal bleeding","Patients ages 18 - 44 years of age and meet these criteria","One risk factor for endometrial cancer (body-mass index (BMI) ≥30 or PCOS or Tamoxifen use)"],"whoShouldSkip":["Current known pregnancy diagnosis","Any prior pelvic or vaginal radiotherapy","Any prior cancer (except basal cell skin cancer) within the past 5 years","Chemotherapy within the past 5 years","Current biopsy-proven cervical, vaginal, or vulvar cancer or lower genital tract dysplasia","Current biopsy-proven endometrial cancer or endometrial hyperplasia","Current biopsy-proven benign endometrial polyp"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,110 people at 25 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.695Z"},{"nctId":"NCT05052216","title":"Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea","officialTitle":"Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","sponsorClass":"NIH","summary":"Background:\n\nObstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies.\n\nObjective:\n\nTo learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor.\n\nEligibility:\n\nChildren aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group).\n\nDesign:\n\nParticipants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well.\n\nParticipants in the NORM group will have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits.\n\nParticipants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight.\n\nThe OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea. They will repeat the sleep study.","conditions":["Pediatric Obstructive Sleep Apnea"],"keywords":["near-infrared spectroscopy (NIRS)","tissue oxygenation","Polysomnography","Natural History"],"interventions":[],"enrollment":120,"startDate":"2022-08-25","completionDate":"2028-01-31","sex":"ALL","minAge":"3 Years","maxAge":"12 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female, aged \\>=3 and \\<13 years\n2. For NORM group: Children without OSA (AHI\\<2)\n3. For OSA group: Children with OSA (AHI\\>=2)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Children \\<3 years or \\>=13 years\n2. Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition.\n3. Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact.\n4. For NORM group: Children with AHI\\>=2\n5. For OSA group: Children with AHI\\<2","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thien T Nguyen","phone":"(301) 814-7234","email":"thien.nguyen4@nih.gov"},{"name":"Bruce J Tromberg","phone":"(301) 496-8859","email":"bruce.tromberg@nih.gov"}],"primaryOutcomes":["ScO2, StO2"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea","inPlainEnglish":"Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects.","whoItsFor":["Ages 3 Years to 12 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Male or female, aged \\>=3 and \\<13 years","For NORM group: Children without OSA (AHI\\<2)","For OSA group: Children with OSA (AHI\\>=2)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Children \\<3 years or \\>=13 years","Any chronic or acute medical condition that in the opinion of the investigators will interfere with overnight sleep study acquisition","Any head injuries or physical conditions that in the opinion of the investigators would affect probe signal and contact","For NORM group: Children with AHI\\>=2","For OSA group: Children with AHI\\<2"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.940Z"},{"nctId":"NCT05058651","title":"Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung","officialTitle":"Randomized Phase II/III Trial of First Line Platinum/Etoposide With or Without Atezolizumab (NSC#783608) in Patients With Advanced or Metastatic Poorly Differentiated Extrapulmonary Neuroendocrine Carcinomas (NEC)","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cisplatin and carboplatin are in a class of medications known as platinum-containing compounds that work by killing, stopping or slowing the growth of cancer cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. Giving atezolizumab in combination with a platinum drug (cisplatin or carboplatin) and etoposide may work better in treating patients with poorly differentiated extrapulmonary neuroendocrine cancer compared to standard therapy with a platinum drug (cisplatin or carboplatin) and etoposide alone.","conditions":["Advanced Extrapulmonary Neuroendocrine Carcinoma","Metastatic Extrapulmonary Neuroendocrine Carcinoma","Recurrent Extrapulmonary Neuroendocrine Carcinoma","Unresectable Extrapulmonary Neuroendocrine Carcinoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Atezolizumab"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Etoposide"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Patient Observation"}],"enrollment":189,"startDate":"2022-06-28","completionDate":"2028-10-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)\n* Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator\n* Participants must have radiologically evaluable disease, measurable or non-measurable, per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. All measurable and nonmeasurable lesions must be assessed by CT scan with IV contrast of the chest/abdomen/and pelvis (or CT chest without contrast and MRI abdomen/pelvis with gadolinium contrast, if contraindication to CT iodinated contrast) within 28 days prior to registration. While may be used for routine clinical evaluation, PET scans and bone scans alone are not acceptable for disease assessment while participating in this study. All known sites of disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants must have brain MRI (or CT head with contrast if there is contraindication to MRI brain) if clinically indicated within 28 days prior to registration. Note: Brain imaging is not required in participants without known and/or clinical concern for brain metastases. Participants with asymptomatic central nervous system (CNS) metastases are eligible if one or more of the following apply:\n\n  * Participants who have received treatment for brain metastases must have:\n\n    * No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration\n    * Discontinued all corticosteroids at least 14 days prior to registration\n  * Participants with treatment-naive brain lesions must have:\n\n    * No lesion measuring \\> 2.0 cm in size in any axis\n    * MRI brain or CT head with contrast (if there is contraindication to MRI brain) demonstrating no evidence for mass effect, edema, or other impending neurological compromise within 28 days prior to registration\n    * No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration\n    * No need for \\> 2 mg of dexamethasone (or equivalent of \\> 10 mg prednisone) per day at time of registration\n* Participants must not have symptomatic central nervous system (CNS) metastases\n* Participants must not have known or suspected leptomeningeal disease\n* Participants with prior history of non-metastatic (localized/locally advanced disease) extrapulmonary poorly differentiated NEC may have had prior platinum-based therapy +/- radiation +/- surgery provided that all therapy was completed \\>= 6 months prior to registration\n* Participants must discontinue denosumab prior to study registration and plan to replace with a bisphosphonate while on the study\n* Participants must not have had prior treatment for advanced or metastatic NEC EXCEPT one cycle of platinum (carboplatin/cisplatin) + etoposide is allowed prior to registration. Other chemotherapy regimens are not allowed. For participants with prostate or urothelial NEC, prior chemotherapy for the non-NEC component (e.g. adenocarcinoma or urothelial) is allowed as long as such therapy was completed \\>= 24 weeks prior to registration and participants have recovered from all prior toxicities to =\\< grade 1.\n* Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, antiPD-L2, CD137 agonists, anti-CTLA-4 agent, or any other immune checkpoint inhibitors for any neuroendocrine neoplasm. Immune checkpoint inhibitors given for other cancer indications are allowed provided last therapy was given at least 12 months prior to study registration\n* Participants must not have received treatment with systemic immunostimulatory agents including, but not limited to, interferon and interleukin2 \\[IL-2\\] within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to registration\n* Participants must not have had history of known severe allergy, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies, including to Chinese hamster ovary cell products or to any component of the atezolizumab formulation, cisplatin, carboplatin, or etoposide\n* Participants must not be on active systemic therapy for another cancer with the exception of hormonal therapy including androgen deprivation therapy (e.g., gonadotropin-releasing hormone \\[GnRH\\] agonists or antagonists), which can be continued while participants are receiving protocol therapy. Use of enzalutamide or apalutamide is permitted after completion of chemotherapy and must be held during chemotherapy for participants receiving prior to enrollment. Use of darolutamide is permitted during chemotherapy. Glucocorticoid-containing regimens, including abiraterone, are not permitted.\n* Participants must be \\>= 18 years of age\n* Participants must have a Zubrod performance status of =\\< 2 within 28 days prior to registration\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9 /L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Hemoglobin \\>= 9.0 g/dl (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Platelet count \\>= 100 x 10\\^9/L (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\< 2.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Serum total bilirubin =\\< 1.5 x ULN (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Adequate renal function as defined by any 1 of the following: 1) Measured creatinine clearance (CL) \\> 50 mL/min OR 2) Calculated creatinine CL \\> 50 mL/min by the Cockcroft-Gault formula OR by 24-hour urine collection for determination of creatinine clearance (obtained within 14 days prior to registration. For participants who received a cycle of chemotherapy prior to registration, at least 21 days must have elapsed between day 1 of platinum + etoposide and performance of these tests)\n* Participants must not have uncontrolled or symptomatic hypercalcemia (\\> 1.5 mmol/L ionized calcium or calcium \\> 12 mg/dL or corrected serum calcium \\> ULN) within 14 days prior to registration. Participants who have asymptomatic hypercalcemia are eligible provided that medical therapy to treat the hypercalcemia is planned\n* Participants must not have a diagnosis of immunodeficiency nor be receiving systemic steroid therapy (equivalent of \\> 20 mg of hydrocortisone per day) or any other form of immunosuppressive therapy within 14 days prior to registration\n* Participants must not have active or history of autoimmune disease or immune deficiency, including, but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis with the following exceptions:\n\n  * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study\n  * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n  * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\< 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids\n    * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months\n* Participants must not have history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. NOTE: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Participants must not have significant cardiovascular disease, such as New York Heart Association class II or greater cardiac disease, myocardial infarction within 3 months prior to registration, unstable arrythmias, or unstable angina\n* Participants must not have had a major surgical procedure other than for diagnosis within 28 days prior to registration. Participant must not plan to receive a major surgical procedure during the course of protocol treatment. NOTE: Patient port placement is not considered a major surgery\n* Participants must not have severe infections (i.e., Common Terminology Criteria for Adverse Events \\[CTCAE\\] grade \\>= 2) at time of registration, including but not limited to hospitalization for complications for infection, bacteremia, or severe pneumonia\n* Participants must not have known active tuberculosis\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load, with testing performed as clinically indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load, with testing performed as clinically indicated\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months of registration\n* Participants must not have prior allogeneic bone marrow transplantation or solid organ transplant\n* Participants must not have received administration of a live, attenuated vaccine (e.g., FluMist \\[registered trademark\\]) within 28 days prior to initiation of study treatment, during treatment with atezolizumab, and not plan to receive for 5 months after the last dose of atezolizumab\n* Participants must not be pregnant due to the possibility of harm to the fetus. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method (with details provided as a part of the consent process) during the treatment period and for 5 months after the final dose of atezolizumab. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking. 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Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Overall 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2 / Phase 3: testing Atezolizumab for Advanced Extrapulmonary Neuroendocrine Carcinoma","inPlainEnglish":"This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). The other aim of this trial is to compare using atezolizumab just at the beginning of treatment versus continuing it beyond the initial treatment.","whoItsFor":["Ages 18 Years to any","Participants must have histologically-confirmed (local site pathological confirmation sufficient) extrapulmonary poorly differentiated, neuroendocrine carcinoma (NEC)","Participants must have disease that is unresectable or metastatic and not eligible for definitive therapy as deemed per the treating investigator","Participants who have received treatment for brain metastases must have:","No evidence of radiological progression (by MRI brain or CT head with contrast if there is contraindication to MRI brain) within 28 days prior to registration","Discontinued all corticosteroids at least 14 days prior to registration","Participants with treatment-who have not tried this kind of treatment before brain lesions must have:","No lesion measuring \\> 2.0 cm in size in any axis"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Atezolizumab, Biospecimen Collection, or Carboplatin. The registry lists allocation as randomized. This phase II/III trial compares the effect of immunotherapy with atezolizumab in combination with standard chemotherapy with a platinum drug (cisplatin or carboplatin) and etoposide versus standard therapy alone for the treatment of poorly differentiated extrapulmonary (originated outside the lung) neuroendocrine cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 189 people at 266 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.000Z"},{"nctId":"NCT05061368","title":"Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD","officialTitle":"The Effect of Oral Sildenafil on Exercise Capacity, Dyspnea and Cardiopulmonary Function in Chronic Obstructive Pulmonary Disease (COPD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion. The mechanisms responsible for shortness of breath on exertion are well understood in moderate and severe COPD, but, are poorly understood in mild COPD where symptoms appear disproportionate to the degree of airway obstruction.\n\nMild COPD patients show an exaggerated breathing response to exercise, determined by the breathing response to carbon dioxide production (V̇E/V̇CO2). Recent work suggests that the increased V̇E/V̇CO2 during exercise in mild COPD is secondary to increased deadspace (i.e. lung regions with ventilation but no perfusion) and/or ventilation/perfusion (V̇A/Q) inequality (poor matching of ventilation to perfusion). Researchers have proposed that the increased deadspace or V̇A/Q inequality is secondary to pulmonary vascular dysfunction and hypoperfusion of the pulmonary capillaries.\n\nRecently, we have shown that inhaled nitric oxide, a potent dilator of pulmonary vasculature, reduces shortness of breath and V̇E/V̇CO2, and improves exercise capacity in mild COPD. This preliminary finding suggests that pulmonary vascular dysfunction is an important contributor to exercise intolerance in mild COPD. Here, we aim to test whether sildenafil, an oral pulmonary vasodilator, can improve exercise tolerance and shortness of breath in mild COPD.","conditions":["Chronic Obstructive Pulmonary Disease"],"keywords":["COPD","Sildenafil","Pulmonary Vascular Function","Pulmonary Vascular Pressure","DLCO","Pulmonary Capillary Blood Volume","Dyspnea","Exercise Tolerance","Peak Oxygen Uptake","Cardiopulmonary Fitness"],"interventions":[{"type":"DRUG","name":"Sildenafil Citrate"},{"type":"OTHER","name":"Placebo"}],"enrollment":160,"startDate":"2022-03-01","completionDate":"2027-05","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants will have COPD as defined as:\n\n1. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal\n2. FEV1 \\>30% of predicted (lower limit of GOLD severe COPD classification)\n\nCOPD Free Controls will have:\n\n1. No diagnosis of COPD\n2. Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) above the lower limit of normal\n3. FEV1 \\>80% of predicted\n\nExclusion Criteria:\n\n1. Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing.\n2. Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing\n3. A diagnosis of pulmonary hypertension preceding COPD\n4. Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use.\n5. Pregnancy or lactation.\n6. Women of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy throughout the study. Acceptable methods of contraception include tubal ligation, oral contraceptive, barrier methods (intra-uterine device, diaphragm, female condom, male condom). Abstinence is an acceptable form of contraception, only insofar as patients agree to use another acceptable method of birth control, preferably a barrier method, if they become sexually active.\n7. Postmenopausal female participants must be amenorrheic for ≥12 months.","locations":[{"facility":"Clinical Physiology Laboratory","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Desi Fuhr, MSc","phone":"7804921121","email":"fuhr@ualberta.ca"},{"name":"Rhys Beaudry, Ph.D.","phone":"7804928027","email":"rhys.beaudry@ualberta.ca"}],"primaryOutcomes":["Exercise Capacity"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["edmonton-canada"],"enrichment":{"headline":"Phase 2: testing Sildenafil Citrate for Chronic Obstructive Pulmonary Disease","inPlainEnglish":"Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction. Patients with COPD experience significant shortness of breath on exertion.","whoItsFor":["Ages 40 Years to 80 Years","Participants will have COPD as defined as:","Post bronchodilator Forced Expiratory Volume in one second (FEV1) to Forced Vital Capacity (FVC) ratio (FEV1/FVC) below the lower limit of normal","FEV1 \\>30% of predicted (lower limit of GOLD severe COPD classification)","COPD Free Controls will have:","No diagnosis of COPD","FEV1 \\>80% of predicted"],"whoShouldSkip":["Absolute contraindication to exercise testing or an orthopedic condition that may limit exercise testing","Pre-existing cardiac conditions (heart failure, congenital heart defect, valvular disease) that may limit exercise testing","A diagnosis of pulmonary hypertension preceding COPD","Current phosphodiesterase type-5 inhibitor, nitrate, opioid, azole antifungal, macrolide antibiotic, protease inhibitor, alpha blocker, riociguat, mifepristone or rifamycin use","Pregnancy or lactation","Postmenopausal female participants must be amenorrheic for ≥12 months"],"whatHappens":"If you join, the listed intervention(s) are Sildenafil Citrate, or Placebo. The registry lists allocation as randomized. Chronic obstructive pulmonary disease (COPD) is a condition characterized by airway obstruction.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.655Z"},{"nctId":"NCT05061953","title":"Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis","officialTitle":"Development of a Novel Functional Eye-Tracking Software Application for Multiple Sclerosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Innodem Neurosciences","sponsorClass":"INDUSTRY","summary":"This study aims to develop and validate a sensitive and non-invasive eye-tracking software application.\n\nThis study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests. The study data will be used to develop machine learning algorithms and validate a software application intended to track the progressive component of multiple sclerosis and associated cognitive changes.","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Eye-Tracking"}],"enrollment":168,"startDate":"2021-10-18","completionDate":"2027-10-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to provide informed consent.\n* Aged 18 years or older at the time of enrollment.\n* Able to read in either French or English.\n* Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc.\n\nare permitted)\n\nFor patients only:\n\n* Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months.\n* Neurological condition is medically stable during the study visit.\n* Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit.\n\nExclusion Criteria:\n\n* Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control.\n* Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia).\n* Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments.\n* Recent (less than three months from enrollment) start of, change of dose, or irregular use of, new prescription drugs known to influence ocular motor visual function, such as benzodiazepines, antipsychotics and anticonvulsants. Occasional use of benzodiazepines for medical procedures is permitted, at the investigator's discretion, but should not occur within a short time period prior to or during an eye movement assessment.\n\nFor healthy controls only:\n\n* Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia.\n\nFor MS patients only\n\n* Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS).\n* Patients who are currently experiencing a relapse or who have experienced a relapse within the last three months. A relapse is defined as appearance of a new neurological abnormality or worsening of previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding clinical demyelinating event (McDonald et al. 2001). The abnormality must have been present for at least 24 hours and occurred in the absence of fever (\\< 37.5°C) or known infection.\n* Patients who have been undergoing disease-modifying therapy for less than three months","locations":[{"facility":"The Neuro","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genge Partners, Inc.","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change from Baseline in Symbol Digit Modalities Test (SDMT) score at Month 48"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: Eye-Tracking for Multiple Sclerosis","inPlainEnglish":"This study aims to develop and validate a sensitive and non-invasive eye-tracking software application. This study will obtain participant responses to brief cognitive tests designed to evaluate several key functions known to be affected by MS and non-invasive eye movement measurements in response to visually presented stimuli during specifically designed eye-tracking tests.","whoItsFor":["Ages 18 Years to any","Aged 18 years or older at the time of enrollment","Able to read in either French or English","Visual acuity of 20/100 in at least one eye (corrective glasses, contact lenses, surgery etc","Confirmed diagnosis of MS with no signs of progressive increase in physical disability within the past six months","Neurological condition is medically stable during the study visit","Expanded Disability Status Scale (EDSS) score 0 - 8.0 at the initial visit"],"whoShouldSkip":["Evidence or medical history of psychiatric issues that are known to also affect movements and oculomotor control","Presence of co-morbid neurological conditions to avoid eye movement anomaly confounds (Strabismus, cranial nerve palsy, stroke-causing hemianopsia)","Diagnosis of macular edema or other pre-existing ocular conditions that would prevent a participant from performing the eye movement assessments","For healthy controls only:","Evidence or history of significant neurodegenerative disorder affecting brain function, e.g., multiple sclerosis (MS), Parkinson's disease (PD), Amyotrophic lateral sclerosis (ALS), Dementia","For MS patients only","Diagnosis of Clinically Isolated Syndrome (CIS), Radiologically Isolated Syndrome (RIS) or Primary Progressive MS (PPMS)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 168 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.974Z"},{"nctId":"NCT05072483","title":"Natural History Study of CADASIL","officialTitle":"Natural History Study of CADASIL","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nCADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia. Researchers want to monitor people with CADASIL over time.\n\nObjective:\n\nTo learn more about how CADASIL affects a person s blood vessels over time.\n\nEligibility:\n\nAdults ages 18 and older who have CADASIL, and healthy volunteers.\n\nDesign:\n\nParticipants will be screened with a medical record review.\n\nParticipants will have 4 study visits over 9 years. Visits will last 6 8 hours per day, for 2 4 days.\n\nParticipants will give blood and urine samples. They will have an electrocardiogram to record their heart s electrical activity. They will fill out a family tree. They will have tests that measure mental abilities like memory and attention. They may have a skin biopsy. They may have a lumbar puncture.\n\nParticipants will have an eye exam. Their pupils will be dilated. They will receive a dye via intravenous (IV) line. Pictures will be taken of their eyes.\n\nParticipants will have an imaging scan of their brain. They may receive a contrast agent via IV.\n\nParticipants blood flow and blood vessel flexibility will be measured. In one test, a probe will be pressed against the skin of the their wrist, neck, and groin. In another test, they will hold one arm still while a microscope makes videos of the blood flow through a fingernail. In another test, they will perform light exercise or other activities while wearing an elastic band around their head or probes placed on their arm or leg.\n\nHealthy volunteers will complete some of the above tests.","conditions":["Cardiovascular Disease","Arterial Stiffness","Germline Mutation in the NOTCH 3 Gene","Pathogenesis of CADASIL","Clinical Phenotype of CADASIL"],"keywords":["Biospecimen Procurement","Laboratory Research Specimens","progressive chronic hypoperfusion","Stroke","progressive white matter degeneration, and debilitating dementia."],"interventions":[{"type":"DEVICE","name":"MRI"}],"enrollment":155,"startDate":"2022-04-18","completionDate":"2034-06-01","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nEligibility for this study may be determined based on information collected under other NHLBI-approved protocols, outside records and patient report.\n\nIn order to be eligible to participate in this study, an individual must meet criteria 1 \\& 2 and either criteria 3 or 4:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Male or female, aged 18 to 100 years (inclusive).\n3. Established diagnosis of CADASIL or NOTCH3 mutations, as determined by genetic testing.\n4. Healthy controls.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy at time of consent.\n2. Subjects who lack capacity to consent and don't have a legally authorized representative.\n3. Subjects who decline to provide samples for blood and/or tissue studies.\n4. Subjects who do not speak English.\n5. Subjects whose scans or examinations show unexpected brain conditions (outside of CADASIL) which would interfere with interpretation of testing.\n6. Subjects unable to undergo an MRI scan or subjects meeting the following criteria:\n\n   * Subjects who have internal non-MRI compatible metals (i.e., cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye) as these rendering an MRI unsafe\n   * Subjects with ferromagnetic dental bridges or crowns (exclusion only for 7.0T)\n   * Subjects unable to remain supine for the expected length of the MRI (i.e., up to 1 hour)\n   * Subjects with uncontrolled head movements\n   * Subjects who are claustrophobic for the expected length of the MRI (i.e., up to 1 hour) and claustrophobia cannot be controlled with anti-anxiety medication.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ruth C Brower, R.N.","phone":"(301) 443-6036","email":"ruth.brower@nih.gov"},{"name":"Elisa A Ferrante Brenlla, Ph.D.","phone":"(301) 402-3577","email":"elisa.ferrante@nih.gov"}],"primaryOutcomes":["This study will examine the pathogenesis of CADASIL through comprehensive clinical evaluations and molecular studies on biospecimens collected under this protocol from affected individuals."],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: MRI for Cardiovascular Disease","inPlainEnglish":"Background: CADASIL (cerebral autosomal dominant arteriopathy with subcortical infarct and leukoencephalopathy) is a genetic disorder. It causes narrowing of the small blood vessels and can lead to strokes and dementia.","whoItsFor":["Ages 18 Years to 100 Years","Eligibility for this study may be determined based on information collected under other NHLBI-approved protocols, outside records and patient report","In order to be eligible to participate in this study, an individual must meet criteria 1 \\& 2 and either criteria 3 or 4:","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged 18 to 100 years (inclusive)","Established diagnosis of CADASIL or NOTCH3 mutations, as determined by genetic testing"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Pregnancy at time of consent","Subjects who lack capacity to consent and don't have a legally authorized representative","Subjects who decline to provide samples for blood and/or tissue studies","Subjects whose scans or examinations show unexpected brain conditions (outside of CADASIL) which would interfere with interpretation of testing","Subjects unable to undergo an MRI scan or subjects meeting the following criteria:","Subjects who have internal non-MRI compatible metals (i.e., cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye) as these rendering an MRI unsafe"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 155 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.217Z"},{"nctId":"NCT05077137","title":"A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy","officialTitle":"A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"The purpose of this study is to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.","conditions":["Melanoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Tetanus Diptheria Vaccine"},{"type":"BIOLOGICAL","name":"Polio Boost Immunization"}],"enrollment":25,"startDate":"2021-09-07","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Histologically confirmed advanced metastatic melanoma\n2. Male or female participants who are at least 18 years of age on the day of signing informed consent\n3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care\n4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial\n5. Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion\n6. Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility\n\n   1. ANC \\>/= 1500/uL\n   2. platelets \\>/=100,000/uL\n   3. Hemoglobin \\>/= 9.0 g/dL\n\nExclusion Criteria:\n\n1. Uveal or mucosal melanoma\n2. Any women known to be pregnant or breastfeeding\n3. Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)\n4. Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy\n5. Patients with symptomatic CNS metastases and/or carcinomatous meningitis\n\n   a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on \\>10mg prednisone daily\n6. History of or active (non-infectious) pneumonitis that required steroids\n7. Active infection requiring systemic therapy\n8. Known history of Human Immunodeficiency Virus (HIV) infection\n9. Known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection. NOTE: no testing for Hepatitis B or Hepatitis C is required\n10. Known history of active TB (Bacillus Tuberculosis)\n11. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician\n12. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n13. History of allogenic tissue or solid organ transplant\n14. History of allergic reaction to IPOL or Td vaccine\n15. Receipt of Td vaccine within 30 days prior to starting IO therapy","locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol Ann Wiggs, BSN","phone":"919-684-0281","email":"carolann.wiggs@duke.edu"}],"primaryOutcomes":["Number of subjects out of the proposed 25 that successfully receive the vaccine after 4 cycles of IO therapy","Safety, as measured by the change in the number and severity of adverse events deemed related to the vaccine or study procedures (blood draw and biopsies)"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Phase 1: testing Tetanus Diptheria Vaccine for Melanoma","inPlainEnglish":"This study wants to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.","whoItsFor":["Ages 18 Years to any","Histologically confirmed advanced metastatic melanoma","Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti CTLA-4 therapy as standard of care","Participant must have at least 1 lesion that is at least 8 mm in size and is cutaneous, subcutaneous, palpable, or amenable to ultrasound guided core biopsy. The lesion chosen for biopsy can also be a target lesion but does not have to be a target lesion","Adequate organ function as defined below. Standard of care labs drawn within 45 days prior to consent may be used for the purposes of determining eligibility","platelets \\>/=100,000/uL","Hemoglobin \\>/= 9.0 g/dL"],"whoShouldSkip":["Uveal or mucosal melanoma","Any women known to be pregnant or breastfeeding","Any prior systemic therapy for metastatic melanoma (prior surgery is allowed)","Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy","Patients with symptomatic CNS metastases and/or carcinomatous meningitis","a) Patients with asymptomatic, stable CNS metastases are allowed provided that they are not on \\>10mg prednisone daily","History of or active (non-infectious) pneumonitis that required steroids"],"whatHappens":"If you join, the listed intervention(s) are Tetanus Diptheria Vaccine, or Polio Boost Immunization. The registry lists allocation as randomized. This study wants to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 25 people at Durham. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.802Z"},{"nctId":"NCT05099315","title":"Microbiome in Atopic Dermatitis Under Systemic Therapy","officialTitle":"Identification of Skin-associated Microbiota in Atopic Dermatitis Patients Undergoing Systemic Therapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Charite University, Berlin, Germany","sponsorClass":"OTHER","summary":"The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation.\n\nThe influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or Janus kinase inhibitors) on the skin microbiome is largely unknown.\n\nThe main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. This not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.","conditions":["Atopic Dermatitis"],"keywords":["dupilumab","cyclosporine","skin microbiome","baricitinib"],"interventions":[{"type":"OTHER","name":"not applicable, observational study"}],"enrollment":600,"startDate":"2019-10-01","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with moderate to severe atopic dermatitis\n* Indication for systemic therapy\n\nExclusion Criteria:\n\n* Patients under 18 years of age upon introducing systemic therapy\n* Pregnant and lactating women","locations":[{"facility":"Dpt of Dermatology and Allergology, Charité - Universitätsmedizin Berlin","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Margitta Worm, Prof","phone":"+49 30 450 518105","email":"margitta.worm@charite.de"},{"name":"Sabine Dölle-Bierke, PhD","phone":"+49 30 450 518367","email":"sabine.doelle@charite.de"}],"primaryOutcomes":["Comparison of the microbial composition","Comparison of microbial composition of the skin with serological biomarkers"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: not applicable, observational study for Atopic Dermatitis","inPlainEnglish":"The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation.","whoItsFor":["Ages 18 Years to any","Patients with moderate to severe atopic dermatitis","Indication for systemic therapy"],"whoShouldSkip":["Patients under 18 years of age upon introducing systemic therapy","Pregnant and lactating women"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 600 people at Berlin. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.833Z"},{"nctId":"NCT05106296","title":"Chemo-immunotherapy Using Ibrutinib Plus Indoximod for Patients With Pediatric Brain Cancer","officialTitle":"Repurposing Ibrutinib for Chemo-Immunotherapy in a Phase 1b Study of Ibrutinib With Indoximod Plus Metronomic Cyclophosphamide and Etoposide for Pediatric Patients With Brain Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Theodore S. Johnson","sponsorClass":"OTHER","summary":"Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.\n\nThe GCC2020 trial is a prospective open-label phase 1 trial to determine the best safe dose of the BTK-inhibitor ibrutinib to use in combination with previously studied chemo-immunotherapy regimens comprised of the investigational IDO-inhibitor indoximod plus oral palliative chemotherapy for participants, age 6 to 25 years, with relapsed or refractory primary brain cancer. Those previously treated with indoximod-based therapy may be eligible, including prior treatment via the phase 2 indoximod study (GCC1949, NCT04049669), the now closed phase 1 study (NLG2105, NCT02502708), or any expanded access (compassionate use) protocols. Ibrutinib will be combined with either indoximod plus oral cyclophosphamide and etoposide (Regimen A) or indoximod plus oral temozolomide (Regimen B). No cross-over between these two regimens will be allowed. Dose-escalation cohorts will determine the best safe dose of ibrutinib for each of these regimens. This will be followed by expansion cohorts, using ibrutinib at the best safe dose for each regimen, to allow assessment of preliminary evidence of efficacy.","conditions":["Ependymoma","Medulloblastoma","Glioblastoma","Primary Brain Tumor"],"keywords":["IDO","indoleamine 2,3-dioxygenase","indoximod","BTK","Bruton's Tyrosine Kinase","ibrutinib","immunotherapy","pediatric","childhood","brain tumor","brain cancer","glioblastoma","medulloblastoma","ependymoma","PNET","cyclophosphamide","etoposide","immune","central nervous system","CNS","temozolomide"],"interventions":[{"type":"DRUG","name":"Indoximod"},{"type":"DRUG","name":"Ibrutinib"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Etoposide"},{"type":"DRUG","name":"Ibrutinib"},{"type":"DRUG","name":"Temozolomide"}],"enrollment":37,"startDate":"2022-02-08","completionDate":"2028-03-30","sex":"ALL","minAge":"3 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nDiagnosis:\n\n* Patients must have prior documented progressive or refractory disease with histologically proven initial diagnosis of ependymoma, medulloblastoma, glioblastoma, or another type of primary cancer of the central nervous system with no curative conventional therapy options available.\n* Metastatic disease is acceptable.\n* Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease.\n\nPatients must be able to swallow pills.\n\nLansky or Karnofsky performance status score must be ≥ 50%.\n\nAdequate renal function:\n\n* Creatinine clearance (CLcr) \\> 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient.\n\nAdequate liver function:\n\n* Alanine aminotransferase (ALT) ≤ 3-times upper limit of normal.\n* Aspartate aminotransferase (AST) ≤ 3-times upper limit of normal.\n* Total bilirubin ≤ 1.5-times upper limit of normal unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin.\n\nAdequate bone marrow function:\n\n* Absolute neutrophil count (ANC) ≥ 1000/mm3 (independent of growth factor support).\n* Platelets ≥ 100,000/mm3 (independent of transfusion support).\n* Hemoglobin ≥ 8 g/dL (independent of transfusion support).\n\nSeizure disorders must be well controlled on antiepileptic medication.\n\nPrior therapy:\n\n* Patients previously treated with chemotherapy drugs included in this protocol are eligible for enrollment.\n* At the time of Screening, patients must be at least 21 days from the administration of any investigational agent (other than indoximod) or prior cytotoxic therapy (including chemotherapy).\n* At the time of Screening, patients must be at least 28 days from administration of antibody-based therapies (e.g., bevacizumab), tumor-directed vaccines, or cellular immune therapies (e.g., T cells, NK cells, etc.).\n* At the time of Screening, patients must be at least 56 days from administration of tumor-directed therapies using infectious agents (e.g., viruses, bacteria, etc.).\n* At the time of Screening, patients must be at least 90 days from any radiation or proton therapy (all modalities, including radiosurgery) that targeted all sites of known disease.\n* There is no lock-out window for patients who were treated with focal radiation or focal proton therapy (all modalities, including radiosurgery) that did not target all disease sites, if at least one site of active tumor is expected to persist and/or grow.\n\nConcurrent anti-neoplastic therapy:\n\n* No investigational or commercial agents, including intrathecal drugs, other than that described by this clinical study protocol (GCC2020) may be administered with the intent to treat the patient's malignancy while they remain enrolled on this study.\n\nContraception, pregnancy, and breastfeeding:\n\n* Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study. Men must agree to not donate sperm during and for 3 months after the study.\n* Women who are pregnant or breastfeeding are ineligible for this study.\n* Patients who become pregnant while participating in this study will have to stop Study Therapy.\n\nPatients, or their parent for patients less than 18 years of age, must sign an Informed Consent Document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.\n\n.\n\nExclusion Criteria:\n\nPatients who are unable to swallow pills.\n\nPatients with known hypersensitivity to any drugs in the treatment plan.\n\nPatients with active autoimmune disease that requires systemic therapy.\n\n* Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.).\n\nPregnant or breastfeeding women.\n\nMajor surgery or a wound that has not fully healed within 4 weeks of Screening.\n\nKnown central nervous system lymphoma.\n\nPatients with active bleeding or history of thrombotic or hemorrhagic stroke, or intracranial hemorrhage, within 6 months prior to Screening; with the exception of retained blood products from recent prior uncomplicated surgery (e.g., tumor biopsy, debulking, or resection; VP shunt placement, etc.).\n\nRequires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon).\n\nRequires chronic treatment with strong CYP3A inhibitor drugs.\n\nClinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.\n\nPatients with baseline QTc interval of more than 470 msec at the time of Screening, and patients with congenital long QT syndrome.\n\nVaccinated with live, attenuated vaccines within 4 weeks of Screening.\n\nKnown history of human immunodeficiency virus (HIV) or active Hepatitis C Virus or active Hepatitis B Virus infection or any uncontrolled active systemic infection.\n\nAny life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib, indoximod, or chemotherapy, or put the study outcomes at undue risk.","locations":[{"facility":"Augusta University, Georgia Cancer Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Theodore S. Johnson, MD, PhD","phone":"706-721-4962","email":"thjohnson@augusta.edu"},{"name":"Robin Dobbins, RN","phone":"706-721-2154","email":"rdobbins@augusta.edu"}],"primaryOutcomes":["Incidence of regimen-limiting toxicity (RLT) for Regimen A","Objective Response Rate (ORR) for Regimen A","Incidence of regimen-limiting toxicity (RLT) for Regimen B","Objective Response Rate (ORR) for Regimen B"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["augusta-georgia"],"enrichment":{"headline":"Phase 1: testing Indoximod for Ependymoma","inPlainEnglish":"Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.","whoItsFor":["Ages 3 Years to 25 Years","Metastatic disease is acceptable","Patients must have MRI confirmation (with and without gadolinium contrast) of current active disease","Patients must be able to swallow pills","Lansky or Karnofsky performance status score must be ≥ 50%","Adequate renal function:","Creatinine clearance (CLcr) \\> 25 mL/min (by calculated methods) AND Creatinine ≤ 1.5-times upper limit of age-adjusted normal for age of patient","Adequate liver function:"],"whoShouldSkip":["Patients who are unable to swallow pills","Patients with known hypersensitivity to any drugs in the treatment plan","Patients with active autoimmune disease that requires systemic therapy","Allergies, allergic conditions, and reactive inflammatory conditions that are not autoimmune in nature would not exclude patients (e.g., eczema, asthma, etc.)","Pregnant or breastfeeding women","Major surgery or a wound that has not fully healed within 4 weeks of Screening","Known central nervous system lymphoma"],"whatHappens":"If you join, the listed intervention(s) are Indoximod, Ibrutinib, or Cyclophosphamide. The registry lists allocation as randomized. Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 37 people at Augusta. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.481Z"},{"nctId":"NCT05112601","title":"Testing Nivolumab With or Without Ipilimumab in Deficient Mismatch Repair System (dMMR) Recurrent Endometrial Carcinoma","officialTitle":"A Randomized Phase II Trial of Nivolumab and Ipilimumab Compared to Nivolumab Monotherapy in Patients With Deficient Mismatch Repair System Recurrent Endometrial Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.","conditions":["Endometrial Adenocarcinoma","Endometrial Clear Cell Adenocarcinoma","Endometrial Dedifferentiated Carcinoma","Endometrial Endometrioid Adenocarcinoma","Endometrial Mixed Cell Adenocarcinoma","Endometrial Mucinous Adenocarcinoma","Endometrial Undifferentiated Carcinoma","Endometrioid Adenocarcinoma","Recurrent Endometrial Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"BIOLOGICAL","name":"Ipilimumab"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"}],"enrollment":81,"startDate":"2022-06-02","completionDate":"2032-07-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with measurable or non-measurable (detectable) recurrent endometrial cancer\n* Measurable disease will be defined and monitored by RECIST v 1.1. Measurable disease is defined per RECIST 1.1 criteria as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be \\>= 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be \\>= 15 mm in short axis when measured by CT or MRI\n* Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:\n\n  * All other lesions (or sites of disease), including small lesions (longest diameter \\<10 mm or pathological lymph nodes with \\>= 10 to \\< 15 mm short axis), are considered non-measurable disease\n  * Ascites and/or pleural effusion attributed to tumor\n  * Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions\n* Patients must have endometrial cancer with deficient mismatch repair system. All patients must have institutional immunohistochemistry (IHC) and/or microsatellite instability (MSI) testing to determine mismatch repair (MMR) status. MMR deficiency is defined as lack of expression of one or more mismatch repair proteins (MLH1, PMS2, MSH2, MSH6, EPCAM) by immunohistochemistry and/or presence of microsatellite instability high using the National Cancer Institute (NCI)-5plex and Promega v1.2 assays, or institutional standards (e.g. next-generation sequencing \\[NGS\\] panel)\n\n  * Method(s) of detection of MMR deficiency will be recorded for each patient. An institutional pathology report, and additional reports if available, documenting these results must be submitted. Patients with \"equivocal\" results on MMR testing by immunohistochemistry may be eligible if they have documented evidence of microsatellite instability by MSI testing or by next generation sequencing assays. MMR testing by IHC may be used to resolve equivocal/indeterminate MSI results\n* Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, mucinous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients may have received 1-2 prior lines of systemic therapy:\n\n  * Prior anti-PD1/PD-L1 therapy is allowed if given in combination with chemotherapy or radiation therapy in adjuvant or primary metastatic/recurrent settings. Patients must have had a complete response and have disease progression/relapse with treatment-free interval of 12 months or more from last dose of therapy with immune check inhibition\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration\n* Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration\n* Any other prior therapy directed at the malignant tumor including chemotherapy, targeted agents, biologic agents, immunologic agents, and any investigational agents, must be discontinued at least 4 weeks prior to registration (6 weeks for nitrosoureas or mitomycin C)\n* Age \\>= 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* Platelets \\>= 100,000/mcl\n* Absolute neutrophil count (ANC) \\>= 1,500/mcl\n* Creatinine =\\< 1.5 x institutional/laboratory upper limit of normal (ULN)\n* Total serum bilirubin level =\\< 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level =\\<3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\< 3 x ULN\n* Adequate oxygen saturation via pulse oximeter (CTCAE v.5.0 hypoxia \\< grade 2 within 28 days prior to registration)\n* Thyroid-stimulating hormone (TSH) within normal limits (TSH \\< ULN allowed in euthyroid patients on thyroid replacement therapy). TSH testing is only required if clinically indicated\n* Patients must have recovered from effects of recent surgery, radiotherapy or chemotherapy. At least 4 weeks must have elapsed since major surgery\n* As clinically indicated, patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better and have a corrected QT (QTc) interval \\< 450 msec\n* The effects of nivolumab, and ipilimumab on the developing human fetus are unknown. For this reason and because nivolumab and ipilimumab are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for 5 months after the last dose of investigational drug. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) do not require contraception\n\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* Patients with evidence of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and the patient is stable off steroids for at least one month\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n* Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n* Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n\nExclusion Criteria:\n\n* Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma\n* Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities\n* Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents\n* Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent\n* Patients on immunosuppressive therapy, with the exception of:\n\n  * Intra-nasal, inhaled, topical or local steroid injections\n  * Premedication for hypersensitivity reaction\n* Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease\n* Patients with known immune impairment who may be unable to respond to anti-CTLA-4 antibody\n* Patients with uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated urinary tract infection), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Women who are pregnant or unwilling to discontinue nursing\n* Prior therapy with CTLA-4 inhibitors, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab, and/or ipilimumab including severe hypersensitivity reactions to any monoclonal antibody","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Cancer and Blood Center LLC","city":"Athens","state":"Georgia","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Augusta University Medical Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Boise","city":"Boise","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Boise","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Caldwell","city":"Caldwell","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Fruitland","city":"Fruitland","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Meridian","city":"Meridian","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois","city":"Chicago","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IU Health North Hospital","city":"Carmel","state":"Indiana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwest Cancer Center - Crown Point","city":"Crown Point","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology LLC","city":"Dyer","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center - Hobart","city":"Hobart","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Mary Medical Center","city":"Hobart","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University/Melvin and Bren Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Catherine Hospital","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Community Hospital","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Diagnostic Center - Munster","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center - Valparaiso","city":"Valparaiso","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa/Holden Comprehensive Cancer Center","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The James Graham Brown Cancer Center at University of Louisville","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UofL Health Medical Center Northeast","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MaineHealth Maine Medical Center- Scarborough","city":"Scarborough","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bronson Battle Creek","city":"Battle Creek","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health Grand Rapids Hospitals - Butterworth Hospital","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Grand Rapids Hospital","city":"Grand Rapids","state":"Michigan","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Bronson Methodist Hospital","city":"Kalamazoo","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Michigan Cancer Center","city":"Kalamazoo","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beacon Kalamazoo Cancer Center","city":"Kalamazoo","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Muskegon Hospital","city":"Muskegon","state":"Michigan","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Corewell Health Lakeland Hospitals - Niles Hospital","city":"Niles","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer and Hematology Centers of Western Michigan - 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute-Edmonds","city":"Edmonds","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute-Issaquah","city":"Issaquah","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center","city":"Seattle","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center-First Hill","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duluth Clinic Ashland","city":"Ashland","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Wisconsin Cancer Center","city":"Ashland","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":["colorectal-cancer","endometrial-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["birmingham-alabama","athens-georgia","augusta-georgia","boise-idaho","caldwell-idaho","coeur-dalene-idaho","fruitland-idaho","meridian-idaho","nampa-idaho","post-falls-idaho","sandpoint-idaho","chicago-illinois","danville-illinois","effingham-illinois","mattoon-illinois","normal-illinois","urbana-illinois","carmel-indiana","crown-point-indiana","dyer-indiana","hobart-indiana","indianapolis-indiana","munster-indiana","valparaiso-indiana","iowa-city-iowa","louisville-kentucky","scarborough-maine","battle-creek-michigan","grand-rapids-michigan","kalamazoo-michigan","muskegon-michigan","niles-michigan","norton-shores-michigan","reed-city-michigan","saint-joseph-michigan","traverse-city-michigan","wyoming-michigan","coon-rapids-minnesota","deer-river-minnesota","duluth-minnesota","edina-minnesota","hibbing-minnesota","minneapolis-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","sandstone-minnesota","shakopee-minnesota","virginia-minnesota","columbia-missouri","st-louis-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","kalispell-montana","missoula-montana","omaha-nebraska","las-vegas-nevada","albuquerque-new-mexico","buffalo-new-york","rochester-new-york","syracuse-new-york","webster-new-york","durham-north-carolina","raleigh-north-carolina","fargo-north-dakota","beachwood-ohio","centerville-ohio","chardon-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","mayfield-heights-ohio","mentor-ohio","parma-ohio","westlake-ohio","oklahoma-city-oklahoma","tulsa-oklahoma","ontario-oregon","portland-oregon","beaver-pennsylvania","butler-pennsylvania","cranberry-township-pennsylvania","erie-pennsylvania","farrell-pennsylvania","greensburg-pennsylvania","indiana-pennsylvania","johnstown-pennsylvania","mckeesport-pennsylvania","mechanicsburg-pennsylvania","monroeville-pennsylvania","moon-township-pennsylvania","mount-pleasant-pennsylvania","n-huntingdon-pennsylvania","natrona-heights-pennsylvania","new-castle-pennsylvania","pittsburgh-pennsylvania","seneca-pennsylvania","washington-pennsylvania","west-mifflin-pennsylvania","providence-rhode-island","dallas-texas","fort-worth-texas","richardson-texas","charlottesville-virginia","richmond-virginia","edmonds-washington","issaquah-washington","seattle-washington","ashland-wisconsin"],"enrichment":{"headline":"Phase 2: testing Ipilimumab for Endometrial Adenocarcinoma","inPlainEnglish":"This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA.","whoItsFor":["Ages 18 Years to any","Women only","Patients with measurable or non-measurable (detectable) recurrent endometrial cancer","Non-measurable (detectable) disease in a patient is defined in this protocol per RECIST 1.1 criteria as one who does not have measurable disease but has at least one of the following conditions:","All other lesions (or sites of disease), including small lesions (longest diameter \\<10 mm or pathological lymph nodes with \\>= 10 to \\< 15 mm short axis), are considered non-measurable disease","Ascites and/or pleural effusion attributed to tumor","Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST 1.1 definitions for target lesions","Patients may have received 1-2 prior lines of systemic therapy:","Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to registration"],"whoShouldSkip":["Patients with a diagnosis of endometrial serous carcinoma or carcinosarcoma","Patients who received prior anti-PD1/PD-L1 therapy and had grade 3-4 or recurring grade 2 immune-related toxicities that led to dose delay or discontinuation of immunotherapy due to those toxicities","Patients who received anti-CTLA-4 therapy or other immunotherapeutic agents","Patients on chronic steroid therapy except those on replacement therapy at a daily dose of 10mg or less prednisone or equivalent","Patients on immunosuppressive therapy, with the exception of:","Intra-nasal, inhaled, topical or local steroid injections","Premedication for hypersensitivity reaction"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Ipilimumab. The registry lists allocation as randomized. This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 81 people at 138 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.163Z"},{"nctId":"NCT05120635","title":"Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans","officialTitle":"Intracranial Neurophysiological Signatures of Fear and Anxiety in Humans","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"DOUBLE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.\n\nThe purpose of this study is to understand the brain mechanisms that produce fear and anxiety in humans. To accomplish this goal, we will measure the brain activity along with the heart rate and skin perspiration of patients while they are completing tasks on a computer. Some of the tasks will also use a virtual reality headset and transport the patient in a video game-like environment. These tasks will expose the participants to various levels of fear-provoking images. Participants with responsive neurostimulation (RNS) implants will be enrolled under Pro00117931 at Duke, but their results for fear and anxiety tasks will be reported under NCT05120635.","conditions":["Fear","GAD","Emotional Memory","PTSD"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Deep Brain Stimulation"},{"type":"BEHAVIORAL","name":"Virtual and augmented reality tasks"}],"enrollment":80,"startDate":"2021-10-01","completionDate":"2027-05-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 years of age or older\n* Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Willing to provide informed consent and participate in the study\n* Ability to read and write English fluently\n\nExclusion Criteria:\n\n* Unwilling to provide informed consent\n* Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement\n* Pregnant women\n* Participants with active psychosis\n* Participants with suicidal ideation\n* Participants with substance abuse issues","locations":[{"facility":"University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Health System","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aaron Halvorsen, PhD","phone":"9196812577","email":"suthanalab@duke.edu"}],"primaryOutcomes":["Physiological change - eye-blinks","Physiological change - heart rate variability","Physiological change - skin conductance","Neurophysiological activity"],"hasResults":false,"conditionSlugs":["als","ptsd","anxiety"],"drugSlugs":[],"locationSlugs":["los-angeles-california","durham-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Deep Brain Stimulation for Fear","inPlainEnglish":"Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments. this study wants to understand the brain mechanisms that produce fear and anxiety in humans.","whoItsFor":["Ages 18 Years to 70 Years","18 years of age or older","Has undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement","Ability to read and write English fluently"],"whoShouldSkip":["Has not undergone acute depth or chronic responsive neurostimulation (RNS) electrode placement","Participants with active psychosis","Participants with suicidal ideation","Participants with substance abuse issues"],"whatHappens":"If you join, the listed intervention(s) are Deep Brain Stimulation, or Virtual and augmented reality tasks. The registry lists allocation as randomized. Anxiety disorders such as post-traumatic stress disorder (PTSD) and generalized anxiety disorder (GAD) affect a large number of individuals with a significant portion of patients failing to improve with current treatments.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.355Z"},{"nctId":"NCT05127005","title":"Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb","officialTitle":"A Multi-center, Investigator-blinded, Randomized, Parallel Group, Superiority Study to Compare the Efficacy of Trapeziectomy Versus Sham Surgery in the Treatment of Osteoarthritis at the Base of the Thumb","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Tampere University Hospital","sponsorClass":"OTHER","summary":"A multi-center randomized placebo-controlled clinical trial which determines the efficacy of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.","conditions":["Thumb Osteoarthritis"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Trapeziectomy"},{"type":"PROCEDURE","name":"Sham"}],"enrollment":132,"startDate":"2022-01-20","completionDate":"2028-09-30","sex":"ALL","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living\n2. Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months.\n3. Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)\n4. Age \\> 45 years\n5. ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)\n6. Ability to speak, understand and read in the language of the clinical site\n7. Provision of informed consent from the participant\n8. Shared decision to proceed with surgical treatment of CMC-1 OA\n\nExclusion Criteria:\n\n1. Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy\n2. Neurologic condition affecting the function or symptoms of the upper extremity\n3. \\<6 months from other surgical procedure of the upper extremities\n4. Rheumatoid arthritis or other inflammatory joint disease\n5. Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides\n6. Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side\n7. \\>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)\n8. Patient is unable to continue his/her current job due to thumb pain","locations":[{"facility":"Helsinki University Central Hospital","city":"Helsinki","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Finland Hospital Nova","city":"Jyväskylä","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kuopio University Central Hospital","city":"Kuopio","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampere University Hospital","city":"Tampere","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jarkko Jokihaara","phone":"+3583311611","email":"jarkko.jokihaara@pirha.fi"}],"primaryOutcomes":["Patient rated wrist and hand evaluation (PRWHE)"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["helsinki-finland","jyv-skyl-finland","kuopio-finland","tampere-finland"],"enrichment":{"headline":"Not a traditional drug phase: Trapeziectomy for Thumb Osteoarthritis","inPlainEnglish":"A multi-center randomly assigned compared with a dummy treatment clinical trial which determines the how well it works of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb. The primary outcome is patient reported evaluation of pain and function of the wrist and hand at 6 months after the randomization to treatment group.","whoItsFor":["Ages 45 Years to any","Primary thumb basal joint (CMC1) osteoarthritis (Eaton Glickel grade 2 or higher) confirmed by standard x-rays and with symptoms limiting activities of daily living","Indication for surgical treatment of thumb basal joint (CMC1) osteoarthritis after insufficient benefit from non-operative treatment, including use of a thumb orthosis and pain medication (NSAIDs or paracetamol, implemented for at least three months","Thumb pain in use of at least 4 on a 0 to10 numerical rating scale (NRS, 10=worst pain)","ASA-classification I-II (American Society for Anesthesiologist's Physical Status Classification System)","Ability to speak, understand and read in the language of the clinical site","Shared decision to proceed with surgical treatment of CMC-1 OA"],"whoShouldSkip":["Patients' main complaint is due to some other problem than primary thumb basal joint (CMC1) osteoarthritis or patient will undergo any other surgery in conjunction with trapeziectomy","Neurologic condition affecting the function or symptoms of the upper extremity","\\<6 months from other surgical procedure of the upper extremities","Rheumatoid arthritis or other inflammatory joint disease","Bilateral thumb basal joint (CMC1) osteoarthritis in which patient requests treatment for both sides","Previous operation due tothumb basal joint (CMC1) osteoarthritis for either side","\\>45 degrees of hyperextension in the thumb MP joint in resting position (zig zag deformity)"],"whatHappens":"If you join, the listed intervention(s) are Trapeziectomy, or Sham. The registry lists allocation as randomized. A multi-center randomly assigned compared with a dummy treatment clinical trial which determines the how well it works of trapeziectomy in patients with persistent painful osteoarthritis at the base of the thumb.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 132 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.522Z"},{"nctId":"NCT05129605","title":"Prostate Cancer Genetic Risk Evaluation and Screening Study","officialTitle":"Prostate Cancer Genetic Risk Evaluation and Screening Study (PROGRESS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and evaluate the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.","conditions":["Prostatic Neoplasm","Prostate Cancer","BRCA2 Mutation","BRCA1 Mutation","ATM Gene Mutation","MMR Mutation","Lynch Syndrome","Genetic Predisposition to Disease"],"keywords":["BRCA2","BRCA1","Mismatch Repair Deficiency","Lynch Syndrome","HOXB13","Family History of Prostate Cancer"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Prostate cancer screening"}],"enrollment":400,"startDate":"2020-02-12","completionDate":"2030-12","sex":"MALE","minAge":"35 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals with a prostate aged 35 years or older\n* No known diagnosis of prostate cancer\n* Life expectancy \\>10 years\n* Meet cohort A, B, or C criteria\n* Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)\n* Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing\n* Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry\n\nExclusion Criteria:\n\n* Prior diagnosis or treatment of prostate cancer\n* Inability to undergo prostate MRI\n* Inability to receive MRI contrast agent","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Olympia Price","phone":"857-238-3838","email":"oprice@partners.org"}],"primaryOutcomes":["Diagnosis of prostate cancer"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Prostate cancer screening for Prostatic Neoplasm","inPlainEnglish":"This study aims to define the natural history of men at high genetic risk for prostate cancer on the basis of specific germline genetic mutations, family history, or Black/African ancestry and measure the utility of prostate MRI as a screening tool. The hypothesis is that this targeted population of men are at elevated risk of developing prostate cancer compared to the general population, and enhanced screening with MRI will enable early detection and diagnosis of potentially aggressive prostate cancer, characterization of the penetrance of specific mutations, and potentially identify new genetic risk mutations.","whoItsFor":["Ages 35 Years to any","Men only","Individuals with a prostate aged 35 years or older","No known diagnosis of prostate cancer","Life expectancy \\>10 years","Meet cohort A, B, or C criteria","Cohort A: Documented pathogenic or likely pathogenic germline genetic mutation in a prostate cancer risk gene from a CLIA-certified laboratory (ATM, ATR, BRCA1, BRCA2, BRIP1, CHEK2, EPCAM, FANCA, GEN1, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51C, RAD51D, TP53)","Cohort B: A strong family history suggestive of high genetic risk for prostate cancer with negative clinical genetic testing","Cohort C: Individuals who self-identify as Black American or Black Caribbean with both parents and all four grandparents of Black/African ancestry"],"whoShouldSkip":["Prior diagnosis or treatment of prostate cancer","Inability to undergo prostate MRI","Inability to receive MRI contrast agent"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.307Z"},{"nctId":"NCT05135091","title":"Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))","officialTitle":"A Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Neurona Therapeutics","sponsorClass":"INDUSTRY","summary":"This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of adverse events) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).","conditions":["Mesial Temporal Lobe Epilepsy"],"keywords":["Epilepsy","MTLE","seizure","EPIC","focal seizures","hippocampus"],"interventions":[{"type":"BIOLOGICAL","name":"NRTX-1001"},{"type":"BIOLOGICAL","name":"NRTX-1001"},{"type":"PROCEDURE","name":"Sham Comparator"}],"enrollment":88,"startDate":"2022-06-16","completionDate":"2029-02","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Male or Female, age ≥18 to ≤75\n2. Focal seizures, clinically defined as unilateral MTLE\n3. Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses\n4. Currently on stable doses (at least 1 month prior to Screening) of approved ASDs\n5. Single seizure focus confirmed within one hippocampus\n6. Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit. (Phase 1/2 only)\n7. Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior to the Screening visit and over a prospective 10-week baseline period prior to Randomization (Phase 3 Only)\n\nKey Exclusion Criteria:\n\n1. Epilepsy due to other medical conditions and/or progressive neurologic disease\n2. Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin.\n3. Significant other medical conditions which would impair safe participation\n4. History of status epilepticus in the 3 years prior to screening.\n5. Primary or secondary immunodeficiency\n6. Suicide attempts in the past year 3 years\n7. Severe psychiatric disorders\n8. Prior lobectomy or LITT procedure\n9. MRI indicating potential malignant lesion\n10. Pregnancy, or currently breastfeeding.","locations":[{"facility":"University of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Arizona Epilepsy Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner-University of Arizona Medical Center Tucson Comprehensive Epilepsy Program","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California Keck Hospital","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Medical Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"George Washington University","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Health Care","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Clinic Foundation","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wayne State University/Detroit Medical Center Comprehensive Epilepsy Program","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University at St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth Hitchcock Medical Center/ Department of Neurology","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaleida Health","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hofstra Northwell Comprehensive Epilepsy Center","city":"Great Neck","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Comprehensive Epilepsy Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Medical University","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Hospital","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Wake Forest Baptist","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Health","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington Regional Epilepsy Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Neurona MedInfo","phone":"650-580-3825","email":"neuronamedinfo@neuronatx.com"},{"name":"Eduardo Dunayevich, MD","phone":"650-436-3045","email":"edunayevich@neuronatx.com"}],"primaryOutcomes":["Frequency of serious or severe AEs (Phase 1/2)","Change in disabling seizure frequency (Phase 3)"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","tucson-arizona","little-rock-arkansas","los-angeles-california","orange-california","palo-alto-california","sacramento-california","san-diego-california","san-francisco-california","aurora-colorado","washington-d-c-district-of-columbia","miami-florida","chicago-illinois","iowa-city-iowa","new-orleans-louisiana","boston-massachusetts","detroit-michigan","st-louis-missouri","lebanon-new-hampshire","buffalo-new-york","great-neck-new-york","new-york-new-york","syracuse-new-york","charlotte-north-carolina","durham-north-carolina","winston-salem-north-carolina","portland-oregon","philadelphia-pennsylvania","dallas-texas","houston-texas","salt-lake-city-utah","seattle-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 3: testing NRTX-1001 for Mesial Temporal Lobe Epilepsy","inPlainEnglish":"This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of side effects) and effective (seizure frequency). NRTX-1001 comprises human interneurons that secrete a neurotransmitter, gamma-aminobutyric acid (GABA).","whoItsFor":["Ages 18 Years to 75 Years","Male or Female, age ≥18 to ≤75","Focal seizures, clinically defined as unilateral MTLE","Has failed to achieve seizure control despite adequate trials of at least 2 ASDs at appropriate doses","Currently on stable doses (at least 1 month prior to Screening) of approved ASDs","Single seizure focus confirmed within one hippocampus","Seizure frequency averages ≥4 per 28-day period, including at least 2 clinical focal seizures per 28-day period with objective manifestations or more severe types, over the 6 months prior to the Screening Visit. (Phase 1/2 only)","Disabling seizure frequency of ≥2 per 28-day period averaged over 3 months prior to the Screening visit and over a prospective 10-week baseline period prior to Randomization (Phase 3 Only)"],"whoShouldSkip":["Epilepsy due to other medical conditions and/or progressive neurologic disease","Evidence of seizure focus outside of the hippocampus or evidence of seizures of non- focal origin","Significant other medical conditions which would impair safe participation","History of status epilepticus in the 3 years prior to screening","Primary or secondary immunodeficiency","Suicide attempts in the past year 3 years","Severe psychiatric disorders"],"whatHappens":"If you join, the listed intervention(s) are NRTX-1001, NRTX-1001, or Sham Comparator. The registry lists allocation as randomized. This clinical trial is designed to test whether a single image-guided intracerebral administration of inhibitory nerve cells, called interneurons (NRTX-1001), into subjects with drug-resistant unilateral mesial temporal lobe epilepsy (MTLE), with or without mesial temporal sclerosis (MTS), is safe (frequency of side effects) and effective (seizure frequency).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 88 people at 36 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.910Z"},{"nctId":"NCT05136196","title":"BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study","officialTitle":"Biomarker Stratified CaboZantinib (NSC#761968) and NivOlumab (NSC#748726) (BiCaZO) - A Phase II Study of Combining Cabozantinib and Nivolumab in Participants With Advanced Solid Tumors (IO Refractory Melanoma or HNSCC) Stratified by Tumor Biomarkers - an immunoMATCH Pilot Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine how quickly patients can be divided into groups based on biomarkers in their tumors. A biomarker is a biological molecule found in the blood, other body fluids, or in tissues that is a sign of a normal or abnormal process or a sign of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. The two biomarkers that this trial is studying are \"tumor mutational burden\" and \"tumor inflammation signature.\" Another purpose of this trial is to help doctors learn if cabozantinib and nivolumab shrink or stabilize the cancer, and whether patients respond differently to the combination depending on the status of the biomarkers.","conditions":["Clinical Stage III Cutaneous Melanoma AJCC v8","Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Clinical Stage IV Cutaneous Melanoma AJCC v8","Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8","Locally Recurrent Head and Neck Squamous Cell Carcinoma","Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma","Locally Recurrent Laryngeal Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oropharyngeal Squamous Cell Carcinoma","Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Melanoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Melanoma","Stage III Hypopharyngeal Carcinoma AJCC v8","Stage III Laryngeal Cancer AJCC v8","Stage III Lip and Oral Cavity Cancer AJCC v8","Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8","Unresectable Melanoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cabozantinib S-malate"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"}],"enrollment":150,"startDate":"2022-12-06","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1 - SPECIMEN SUBMISSION\n* Participants must have histologically confirmed melanoma that is stage III or IV, unresectable, recurrent, or metastatic non-uveal melanoma OR Participants must have histologically confirmed squamous cell carcinoma of the head and neck (HNSCC) that is either locally recurrent and non-amendable to curative therapy (e.g., radiation, surgery) or metastatic. The primary tumor location must be the oropharynx, oral cavity, hypopharynx, or larynx. Primary tumor site of nasopharynx (any histology) or unknown primary tumor are not eligible\n\n  * Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration\n* Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration\n* Participants must have had documented progression during or within 12 weeks after the last dose of PD-1 checkpoint inhibition-based therapy. Participants must have been receiving checkpoint inhibition for a minimum of 6 weeks. Participants who recur during adjuvant anti-PD1 treatment or within 12 weeks of completion of adjuvant anti-PD1 treatment are eligible if they have measurable disease and are considered unresectable\n* Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration\n* Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration\n* Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)\n* Participants must not have experienced myocardial infarction or thromboembolic event requiring anticoagulation within 90 days prior to step 1 registration, unless clinically stable with ongoing medical management\n* Participants must have recovered to baseline or =\\< grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 toxicities related to any prior treatments, unless adverse events are deemed clinically nonsignificant by the treating investigator or stable on supportive therapy\n* Participants must not have received more than one prior primary radiotherapy regimen, curative or adjuvant, to the mucosal surfaces of the head and neck, with the additional following criteria:\n\n  * If the primary radiation is combined with chemotherapy, a minimum of 16 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration. If the radiation is given alone, a minimum of 8 weeks will be required to have elapsed between the end of radiotherapy and step 1 registration\n  * Additional palliative radiotherapy regimens are permitted but cannot have been administered to previously treated tissue (i.e., overlapping fields are excluded) with the exception of central nervous system (CNS) radiation and must be completed at least 4 weeks prior to step 1 registration\n  * Treatment areas should be healed with no sequelae from radiation therapy (RT) that would predispose to fistula formation\n* Participants must not have received prior treatment with anti-VEGF therapies for any reason\n* Participants must be \\>= 18 years of age\n* Participants must have a Zubrod Performance Status 0 or 1\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must be class 2B or better to be eligible for this trial\n* Participants must not have any known significant organ disfunction that, in the opinion of the treating investigator, may impact suitability for receiving combination nivolumab/cabozantinib treatment\n* Participants must be able to take oral medication without breaking, opening, crushing, dissolving or chewing capsules\n* Participants must not have malabsorption syndrome\n* Participants must not have active autoimmune disease requiring systemic steroids (equivalent of \\> 10mg of prednisone) or other immune suppression. Exceptions:\n\n  * Type 1 diabetes mellitus\n  * Endocrinopathy only requiring hormone replacement\n  * Skin disorders (e.g., vitiligo, psoriasis, or alopecia) not requiring systemic treatment\n  * Conditions not expected to recur in the absence of an external trigger\n* Participants must not have received an organ allograft\n* Participants must not have a history of hemoptysis (defined as \\>= 1/2 tsp of bright red blood per day) or tumor bleeding within 90 days prior to step 1 registration\n* Participants must not have any of the following criteria due to the possibility of increased risk for tumor bleeding with cabozantinib therapy:\n\n  * Prior carotid bleeding\n  * Tumors that invade major vessels (e.g., the carotid) as shown unequivocally by imaging studies\n  * Central (e.g., within 2 cm from the hilum) lung metastases that are cavitary as shown unequivocally by imaging studies\n  * Any prior history of bleeding related to the current head and neck cancer\n  * History of gross hemoptysis (bright red blood of 1/2 teaspoon or more per episode of coughing) within 3 months\n* Participants must not require concomitant anticoagulation with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct factor Xa inhibitor betrixaban, or platelet inhibitors (e.g., clopidogrel)\n\n  * Participants must not require anticoagulants except for the following:\n\n    * Prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH).\n    * Therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors, rivaroxaban, edoxaban, or apixaban in participants without known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to step 1 registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* Participants must not have evidence of preexisting uncontrolled hypertension 28 days prior to step 1 registration as documented by baseline blood pressure reading with systolic blood pressure \\> 150 mmHg and/or diastolic blood pressure \\> 90 mmHg. Participants on antihypertensive therapies with controlled blood pressure are eligible\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing due to the known safety profiles of the drugs in this study. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential\". In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion and vasectomy with testing showing no sperm in the semen\n* Have an adequate archival tissue specimen verified by the local pathologist and documented on the Pathology Review Form from a procedure obtained after the development of resistance to anti-PD-1/L1 therapy. Archival tissue must consist of tumor block or at least 1 hematoxylin and eosin (H\\&E)-stained 4-5 micron slide and 20 freshly cut serially sectioned and numbered 4-5 micron unstained, uncharged slides OR\n\nBe willing to undergo research biopsy AND have tumor accessible for biopsy based on the following criteria:\n\n* Mediastinal, laparoscopic, gastrointestinal, or bronchial endoscopic biopsies can be obtained incidentally to a clinically necessary procedure and NOT for the sole purpose of the clinical trial\n* Acceptable biopsy procedures are:\n\n  * Percutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications \\< 2%\n  * Direct transoral biopsy (with or without local anesthetic and/or sedation) with an expected risk of severe complications \\< 2%\n  * Excisional cutaneous biopsy with local anesthetic and/or sedation with an expected risk of severe complications \\< 2%\n  * Biopsy with removal of additional tumor tissue during a medically necessary mediastinoscopy, laparoscopy, gastrointestinal endoscopy, bronchoscopy or craniotomy. No open surgical, laparoscopic or endoscopic procedure should be performed solely to obtain a biopsy for this protocol\n  * Removal of additional tumor tissue during a medically necessary surgical procedure\n\n    * Participants must submit whole blood for germline genomic analysis\n    * Participants must have been offered the opportunity to participate in specimen banking\n    * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* Participants with impaired decision-making capacity are eligible as long as their neurological or psychological condition does not preclude their safe participation in the study (e.g., tracking pill consumption and reporting adverse events to the investigator)\n\n  * STEP 2 TREATMENT REGISTRATION\n* Note: No tests or exams are required to be repeated for step 2 registration (Treatment). However, participants who are known to have a change in eligibility status after step 1 registration are not eligible for step 2 registration\n\n  * Participants must continue to meet eligibility for step 1 registration prior to step 2 registration\n  * Participants must have had their tumor tissue submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System prior to step 2 registration\n  * Participants registered during stage II of the protocol must have received assignment to an open cohort from the SWOG Statistics and Data Management Center based on their biomarker screening profile (not applicable for patients registered during stage I of the protocol)\n  * Participants must have measurable disease. All measurable disease must be assessed within 28 days prior to step 2 registration. All non-measurable disease must be assessed within 42 days prior to step 2 registration. Note: All disease must be assessed and documented on the Baseline Tumor Assessment Form (Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n  * For melanoma participants, CT chest, abdomen and pelvis must be obtained. For HNSCC participants, CT neck and chest must be obtained. Further imaging (i.e., MR brain, CT abdomen/pelvis or extremities, bone scan) will be performed as deemed appropriate by the treating physician\n  * Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy\n  * Participants must not have experienced any significant health changes that, in the opinion of the treating investigator, may impact continued suitability for receiving combination nivolumab/cabozantinib treatment\n  * Participants with treated brain metastases must have discontinued steroid treatment at least 14 days prior to step 2 registration\n  * Participants must not have received investigational agents or monoclonal antibodies (except Food and Drug Administration \\[FDA\\] approved supportive care antibodies, such as denosumab) within 28 days prior to step 2 registration\n  * Participants must not have received surgery, chemotherapy, radiation therapy, biologic agents, or steroids within 14 days prior to step 2 registration\n  * Participants must not have received administration of a live, attenuated vaccine within 30 days prior to step 2 registration. Note: Participants may have received a messenger ribonucleic acid (mRNA) or viral vector-based coronavirus disease 2019 (COVID-19) vaccine within 30 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inducers, such as but not limited to rifampin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort, within 14 days prior to step 2 registration\n  * Participants must not have received administration of any strong CYP3A4 inhibitors, such as but not limited to clarithromycin, itraconazole, ketoconazole, grapefruit juice, indinavir, nelfinavir, ritonavir, nefazodone, saquinavir, and telithromycin, within 5 times the half-life of the CYP3A inhibitor prior to step 2 registration\n  * Participants must have a history and physical examination performed within 28 days prior to step 2 registration\n  * Leukocytes \\>= 3,000/uL (within 28 days prior to step 2 registration)\n  * Absolute neutrophil count \\>= 1,500/uL (within 28 days prior to step 2 registration)\n  * Platelets \\>= 100,000/uL (within 28 days prior to step 2 registration)\n  * Total bilirubin =\\< 1.5 x institutional upper limit of normal (ULN) or =\\< 3 x ULN for participants with Gilbert's disease (within 28 days prior to step 2 registration)\n  * Aspartate aminotransferase (AST) =\\< 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Alanine aminotransferase (ALT) =\\< 3 x institutional ULN (within 28 days prior to step 2 registration)\n  * Urinalysis: For baseline value (no required value for eligibility)\n  * Measured (OR calculated) creatinine clearance \\>= 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to step 2 registration","locations":[{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute - West Los Angeles Office","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los 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2: testing Cabozantinib S-malate for Clinical Stage III Cutaneous Melanoma AJCC v8","inPlainEnglish":"This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","STEP 1 - SPECIMEN SUBMISSION","Note: For participants with primary oropharyngeal cancer, human papillomavirus (HPV) or p16 status must be known prior to step 1 registration","Participants must have disease presentation consistent with measurable disease. Note: Current disease measurements will not be required until step 2 registration","Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test within 6 months prior to step 1 registration","Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to step 1 registration","Participants with a history of hepatitis C virus (HCV) infection must have no detectable viral load within 28 days prior to step 1 registration","Participants must not have an active infection requiring systemic therapy (except HBV, HCV or HIV as mentioned above)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Cabozantinib S-malate. The registry lists allocation as na. This phase II trial studies the good and bad effects of the combination of drugs called cabozantinib and nivolumab in treating patients with melanoma or squamous cell head and neck cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at 232 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.818Z"},{"nctId":"NCT05137054","title":"A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments","officialTitle":"Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.\n\nIn the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies).\n\nThis study is the first time linvoseltamab will be combined with other cancer therapies.\n\nThe main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination.\n\nThe study is looking at several other research questions, including:\n\n* How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma\n* What side effects may happen from taking linvoseltamab together with another cancer treatment\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)","conditions":["Multiple Myeloma"],"keywords":["Relapsed/Refractory Multiple Myeloma (RRMM)","B-cell maturation antigen (BCMA)","Anti-CD3 monoclonal antibodies (mAbs)"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"},{"type":"DRUG","name":"Daratumumab"},{"type":"DRUG","name":"Carfilzomib"},{"type":"DRUG","name":"Lenalidomide"},{"type":"DRUG","name":"Bortezomib"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Isatuximab"},{"type":"DRUG","name":"Fianlimab"},{"type":"DRUG","name":"Cemiplimab"},{"type":"DRUG","name":"Nirogacestat"},{"type":"DRUG","name":"Cevostamab"}],"enrollment":317,"startDate":"2022-08-17","completionDate":"2028-03-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"General Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n2. Participants must have measurable disease as defined in the protocol according to IMWG consensus criteria\n3. Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol\n4. Life expectancy of at least 6 months\n\nCohort Specific Inclusion Criteria:\n\nFor cohorts 1-6, each participant must have RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 Proteasome Inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD Cohort 1: Prior treatment with daratumumab is allowed if previously tolerated, as described in the protocol Cohort 2: Prior treatment with carfilzomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 3: Prior treatment with lenalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 4: Prior treatment with bortezomib is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 5: Prior treatment with pomalidomide is allowed if previously tolerated at the approved full dose, as described in the protocol Cohort 6: Prior treatment with isatuximab is allowed if previously tolerated, as described in the protocol\n\nCohort 7 and 8:\n\n1. For participants without measurable disease by biochemical parameters \\[serum or urine M-protein, or serum involved Free Light Chain (FLC)\\], presence of at least 1 soft tissue plasmacytoma with a single diameter of ≥2 cm\n2. RRMM with progressive disease and received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI or triple-class refractory disease (anti-CD38 antibody, IMiD, PI) Cohort 9: Progressive RRMM in participants with triple-class refractory disease (anti-CD38 antibody, IMiD, PI) after at least 3 lines of therapy Cohort 10: Progressive RRMM after at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI\n\nGeneral Key Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)\n2. Participants with known MM brain lesions or meningeal involvement\n3. Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter\n4. History of allogeneic and autologous stem cell transplantation, as described in the protocol\n5. Unless stated otherwise in a specific sub-protocol, prior treatment with a T cell-based immunotherapy directed against B-Cell Maturation Antigen (BCMA) bispecific antibodies and Bispecific T-cell Engagers (BiTEs), and BCMA Chimeric Antigen Receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded)\n6. History of progressive multifocal leukoencephalopathy, neurodegenerative condition or Central Nervous System (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded\n7. Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential\n8. Cardiac ejection fraction \\<40% by Echocardiogram (Echo) or Multigated Acquisition (MUGA) scan\n\nCohort Specific Exclusion Criteria:\n\nCohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed Cohort 4: Peripheral neuropathy grade ≥2 Cohort 5: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed\n\nCohort 7:\n\n1. Prior treatment with anti-Lymphocyte Activation Gene 3 (LAG-3) agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Programmed cell Death Protein 1 (PD-1) antibodies is permitted, as described in the protocol\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol\n3. Prior solid organ transplant\n4. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies\n\nCohort 8:\n\n1. Prior treatment with anti-PD-1 or anti-PD-L1 agents. Prior exposure to vaccine therapies or other immune checkpoint modulating therapies such as anti-Cytotoxic T Lymphocyte-Associated Antigen 4 (CTLA-4) antibodies is permitted, as described in the protocol\n2. Encephalitis or meningitis in the year prior to enrollment\n3. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis or organizing pneumonia), of active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management, or of pneumonitis within the last 5 years. A history of radiation pneumonitis in the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to enrollment\n4. Ongoing or recent (within 2 years) evidence of an autoimmune disease that has required systemic treatment with immunosuppressive agents, as described in the protocol.\n5. Prior solid organ transplant\n6. History of grade ≥3 immune-mediated adverse events (with the exclusion of endocrinopathies that are fully controlled by hormone replacement) from prior checkpoint inhibitor therapies\n\nCohort 9:\n\n1. Abnormal QT interval corrected by Fridericia's formula (QTcF), as described in the protocol\n2. Use of concomitant medications that are known to prolong the QT/QTcF interval including Class Ia and Class III antiarrhythmics at the time of informed consent\n3. Ongoing use or anticipated use of food or drugs that are known strong/moderate cytochrome P450 (CYP)3A4 inhibitors, or strong CYP3A inducers within 14 days prior to first dose of nirogacestat\n4. Known malabsorption syndrome or existing gastrointestinal GI condition that may impair absorption of nirogacestat; delivery of nirogacestat via nasogastric tube or gastrostomy tube is not allowed\n\nCohort 10:\n\n1. Known or suspected active Epstein-Barr Virus (EBV) infection\n2. Known history of Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS)\n3. Prior treatment with cevostamab or another agent with the same target \\[Fragment crystallizable Receptor-like 5 (FcRH5)\\]\n\nDose finding portion: Prior treatment with any BCMA-directed immunotherapy will not be exclusionary, as described in the protocol Dose expansion portion: Prior treatment with any T cell-engaging bispecific antibody directed against BCMA will be exclusionary, as described in the protocol\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"Scripps Clinic Torrey Pines","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute of Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber/Harvard Cancer Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine/New York Presbyterian Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Presbyterian Hospital Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Health Sciences","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University James Cancer Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VA Puget Sound Health Care System","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Poitiers","city":"Poitiers","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Lille - Rue Michel Polonovski","city":"Lille","state":"Nord","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nantes University Hospital","city":"Nantes","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire Angers","city":"Angers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Montpellier - Departement D'Hematologie","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Antoine Hospital","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Henri Mondor","city":"Créteil","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Louis Hospital","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Necker","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelismos General Hospital","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Athens Alexandra","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Santiago","city":"Santiago de Compostela","state":"A Coruna","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marques de Valdecilla","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Quiron Salud Madrid","city":"Pozuelo de Alarcón","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Catala d'Oncologia (ICO) - Hospital Duran i Reynals,","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaru Hospital La Princesa","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra - Madrid","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal - Servicio de Psiquiatria","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital and Research Institute","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario HM Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period","Incidence of Treatment-Emergent Adverse Events (TEAEs)","Severity of TEAEs","Incidence of Serious Adverse Events (SAEs)","Severity of SAEs","Incidence of Adverse Events of Special Interest (AESIs)","Severity of AESIs","Incidence of laboratory abnormalities"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["la-jolla-california","atlanta-georgia","indianapolis-indiana","boston-massachusetts","detroit-michigan","rochester-minnesota","new-york-new-york","chapel-hill-north-carolina","winston-salem-north-carolina","columbus-ohio","dallas-texas","seattle-washington","poitiers-france","lille-france","nantes-france","angers-france","montpellier-france","paris-france","villejuif-france","cr-teil-france","athens-greece","ramat-gan-israel","haifa-israel","jerusalem-israel","santiago-de-compostela-spain","badalona-spain","santander-spain","pozuelo-de-alarc-n-spain","pamplona-spain","barcelona-spain","madrid-spain","salamanca-spain"],"enrichment":{"headline":"Phase 1: testing Linvoseltamab for Multiple Myeloma","inPlainEnglish":"This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status ≤1","Participants must have measurable disease as defined in the protocol according to IMWG consensus criteria","Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol","Life expectancy of at least 6 months","Cohort Specific who can join:","For participants without measurable disease by biochemical parameters \\[serum or urine M-protein, or serum involved Free Light Chain (FLC)\\], presence of at least 1 soft tissue plasmacytoma with a single diameter of ≥2 cm"],"whoShouldSkip":["Diagnosis of plasma cell leukemia, primary light-chain amyloidosis (excluding myeloma associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal protein, and Skin changes)","Participants with known MM brain lesions or meningeal involvement","Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter","History of allogeneic and autologous stem cell transplantation, as described in the protocol","History of progressive multifocal leukoencephalopathy, neurodegenerative condition or Central Nervous System (CNS) movement disorder or participants with a history of seizure within 12 months prior to study enrollment are excluded","Live or attenuated vaccination within 28 days prior to first study drug regimen administration with a vector that has replicative potential","Cardiac ejection fraction \\<40% by Echocardiogram (Echo) or Multigated Acquisition (MUGA) scan"],"whatHappens":"If you join, the listed intervention(s) are Linvoseltamab, Daratumumab, or Carfilzomib. The registry lists allocation as randomized. This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 317 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.498Z"},{"nctId":"NCT05139056","title":"Multiple Intracerebral Doses of Neural Stem Cell-Based Virotherapy (NSC-CRAd-S-pk7) for the Treatment of Recurrent High-Grade Gliomas","officialTitle":"A Phase I Study of Multiple Doses of Neural Stem Cell-Based Oncolytic Virotherapy (NSC-CRAd-S-pk7) Administered Intracerebrally to Patients With Recurrent High-Grade Gliomas","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells. Giving multiple doses of NSC-CRAd-S-pk7 may kill more tumor cells.","conditions":["Currently Only Enrolling Glioblastoma Patients at First Recurrence"],"keywords":["Recurrent glioblastoma, oncolytic virus, neural stem cells, first recurrence"],"interventions":[{"type":"BIOLOGICAL","name":"Neural Stem Cells-expressing CRAd-S-pk7"},{"type":"PROCEDURE","name":"Resection"}],"enrollment":36,"startDate":"2023-05-02","completionDate":"2028-02-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must be age \\>= 18 years\n* Patient has a Karnofsky performance status of \\>= 70%\n* Patient has a life expectancy of \\>= 3 months\n\n  * When determining the maximum tolerated number of treatment cycles (MTC): patient has a histologically confirmed diagnosis of a grade 3 or 4 glioma (eg., glioblastoma, grade 4 astrocytoma, grade 3 astrocytoma, grade 3 oligodendroglioma). (This part of the study has been completed).\n  * When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence.\n* Imaging studies show evidence of recurrent, supratentorial tumor(s).\n* Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide\n* The patient must be in need of surgery for tumor resection\n* Based on the neurosurgeon's judgment, there is no anticipated physical connection between the post-resection tumor cavity and the cerebral ventricles\n* Absolute neutrophil count (ANC) of \\>= 1000 cells/mm\\^3\n* Platelet count \\>= 100,000 cells/mm\\^3\n* Total bilirubin =\\< 2.0 mg/dl\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) =\\< 4 times the institutional upper limit of normal\n* Serum creatinine =\\< the institutional upper limit of normal\n* At least 2 weeks from taking the last dose of a targeted agent\n* At least 4 weeks from the last dose of bevacizumab For temozolomide, an interval of 23 days is required from the last dose administered if the patient was recently treated with adjuvant temozolomide, consisting of temozolomide daily for 5 days, repeated every 28 days.\n* At least 2 weeks from taking the last dose of a targeted agent.\n* At least 4 weeks from the last dose of bevacizumab.\n* All significant toxicities from previous anticancer therapy must have stabilized to a new baseline or resolved.\n* All participants must have the ability to understand and the willingness to sign a written informed consent.\n* The effects of this treatment on a developing fetus are unknown. Therefore, female patients of childbearing potential and sexually-active male patients or who are able to impregnate their partner, must agree to use an effective method of contraception while participating in this study. Patients of childbearing potential must have a negative pregnancy test =\\< 2 week prior to registration.\n\nExclusion Criteria:\n\n* Patient has multi-focal disease.\n* Patient is receiving radiation, chemotherapy, or another investigational agent.\n* Patient has had prior therapy with neural stem cells.\n* Patient has not recovered from any toxicity (\\> grade 1) of prior therapies, except alopecia.\n* Patient is unable to undergo a brain MRI.\n* Patient has chronic or active viral infections of the central nervous system (CNS).\n* Patient has a coagulopathy or bleeding disorder.\n* Patient has an uncontrolled illness including ongoing or active infection.\n* Patient has another active malignancy.\n* Patient is pregnant or breastfeeding.\n* A patient has a serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the safety monitoring requirements and completion of treatment according to this protocol.","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Standford University","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Wake Forest University","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of adverse events","Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["duarte-california","stanford-california","chicago-illinois","winston-salem-north-carolina"],"enrichment":{"headline":"Phase 1: testing Neural Stem Cells-expressing CRAd-S-pk7 for Currently Only Enrolling Glioblastoma Patients at First Recurrence","inPlainEnglish":"This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells.","whoItsFor":["Ages 18 Years to any","Patient must be age \\>= 18 years","Patient has a Karnofsky performance status of \\>= 70%","Patient has a life expectancy of \\>= 3 months","When enrolling to Treatment Schedules 4 and 4a: patient has glioblastoma at first recurrence","Imaging studies show evidence of recurrent, supratentorial tumor(s)","Patient's high-grade glioma has recurred or progressed after prior treatment with brain radiation and temozolomide","The patient must be in need of surgery for tumor resection"],"whoShouldSkip":["Patient has multi-focal disease","Patient is receiving radiation, chemotherapy, or another investigational agent","Patient has had prior therapy with neural stem cells","Patient has not recovered from any toxicity (\\> grade 1) of prior therapies, except alopecia","Patient is unable to undergo a brain MRI","Patient has chronic or active viral infections of the central nervous system (CNS)","Patient has a coagulopathy or bleeding disorder"],"whatHappens":"If you join, the listed intervention(s) are Neural Stem Cells-expressing CRAd-S-pk7, or Resection. The registry lists allocation as na. This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 4 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.476Z"},{"nctId":"NCT05142800","title":"Screening For BCRL In Targeted Therapy For Breast Cancer","officialTitle":"Screening for Edema and Breast Cancer-Related Lymphedema in Patients Undergoing Targeted Therapy for Breast Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer.\n\nA Perometer and Sozo devise will be used to measure volume changes","conditions":["Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage","Breast Cancer"],"keywords":["Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Lymphedema of Upper Limb","Lymphedema of the Hands","Edema","Edema Arm","Breast Cancer Lymphedema","Breast Cancer Metastatic","Breast Cancer Stage","Breast Cancer"],"interventions":[{"type":"DEVICE","name":"Perometer"},{"type":"DEVICE","name":"SOZO device"}],"enrollment":261,"startDate":"2018-12-13","completionDate":"2027-09-30","sex":"FEMALE","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects who are receiving treatment in the MGH Breast Cancer Center who are enrolled in a DF/HCC-regulated targeted therapy trial for the treatment of early or metastatic breast cancer or patients being treated with a targeted therapy that may alter their risk of developing edema or BCRL will be eligible.\n* Subjects that will be eligible for the study include:\n* Females between 18 and 80 years of age\n* With a history of breast cancer\n* 4 weeks or more post-surgery\n* With or without edema\n* Undergoing treatment with targeted therapy for early or metastatic disease.\n\nExclusion Criteria:\n\n\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer).","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alphonse G. Taghian, MD","phone":"617-643-1306","email":"ataghian@partners.org"}],"primaryOutcomes":["Proportion of participants with a greater than or equal to 10% arm volume change from the first pre-treatment (targeted therapy) measurement, detected by perometry, occurring at least three months after breast surgery"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Perometer for Lymphedema","inPlainEnglish":"This a prospective, longitudinal study designed to track edema and Breast Cancer Related Lymphedema (BCRL) onset in breast cancer patients taking targeted therapy treatments for early and metastatic breast cancer. A Perometer and Sozo devise will be used to measure volume changes","whoItsFor":["Ages 18 Years to 80 Years","Women only","Subjects that will be eligible for the study include:","Females between 18 and 80 years of age","With a history of breast cancer","4 weeks or more post-surgery","With or without edema","Undergoing treatment with targeted therapy for early or metastatic disease"],"whoShouldSkip":["\\- Patients who cannot attain 90 degrees of shoulder abduction (position of measurement with Perometer)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 261 people at Boston. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.966Z"},{"nctId":"NCT05147701","title":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION","officialTitle":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for the Treatment of Non-arteritic Ischemic Optic Neuropathy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Foundation for Orthopaedics and Regenerative Medicine","sponsorClass":"OTHER","summary":"This trial will study the safety and efficacy of intranasal delivery of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of non-arteritic ischemic optic neuropathy","conditions":["Eye Diseases","Retinitis Pigmentosa","Diabetic Retinopathy","Macular Degeneration","Traumatic Optic Neuropathy","Optic Atrophy"],"keywords":["Eye Diseases","Retinitis Pigmentosa","stem cell treatment","Diabetic Retinopathy","Macular Degeneration","Traumatic Optic Neuropathy","Optic Atrophy"],"interventions":[{"type":"BIOLOGICAL","name":"cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes"}],"enrollment":20,"startDate":"2022-02-01","completionDate":"2028-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of NAION (non-arteritic ischemic optic neuropathy)\n* Understanding and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant Abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.\n* Continued drug abuse\n* Pre-menopausal women not using contraception\n* Previous organ transplant\n* Hypersensitivity to sulfur","locations":[{"facility":"Prodromos Stem Cell Institute","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prodromos Stem Cell Institute","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chadwick Prodromos, MD","phone":"847-699-6810","email":"care@thepsci.com"}],"primaryOutcomes":["Safety (adverse events)"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["naples-florida","athens-greece"],"enrichment":{"headline":"Phase 1: testing cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for Eye Diseases","inPlainEnglish":"This trial will study the safety and how well it works of intranasal delivery of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of non-arteritic ischemic optic neuropathy","whoItsFor":["Diagnosis of NAION (non-arteritic ischemic optic neuropathy)"],"whoShouldSkip":["Chronic multisystem organ failure","Clinically significant Abnormalities on pre-treatment laboratory evaluation","Medical condition that would (based on the opinion of the investigator) compromise patient's safety","Continued drug abuse","Pre-menopausal women not using contraception","Previous organ transplant","Hypersensitivity to sulfur"],"whatHappens":"If you join, the listed intervention(s) are cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes. The registry lists allocation as na. This trial will study the safety and how well it works of intranasal delivery of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of non-arteritic ischemic optic neuropathy","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.153Z"},{"nctId":"NCT05155033","title":"Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma","officialTitle":"Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nAldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma. Researchers want to see if these drugs can be used together to produce better results in people with these types of cancer.\n\nObjective:\n\nTo learn if the combination of pembrolizumab and aldesleukin can be used to treat metastatic or advanced melanoma and renal cell cancer.\n\nEligibility:\n\nAdults aged 18 years or older who have metastatic or advanced melanoma or renal cell carcinoma.\n\nDesign:\n\nParticipants will be screened with:\n\n* Medical history\n* Physical exam\n* Electrocardiogram\n* Blood and urine tests\n* Ability to perform tasks of daily living\n* Imaging scans (CT, MRI, PET, and/or X-rays). They may get a contrast agent to enhance the images.\n* Photographs, if needed\n\nSome of these tests will be repeated during the study.\n\nParticipants will receive the study drugs by IV (a plastic tube that is put into a vein) for 4 days. A second cycle of treatment will be given 21 days later. They will stay in the hospital for each of the cycles in the first course of treatment. After 2 months, their cancer will be evaluated. They may receive a second course of pembrolizumab alone on Days 1 and 21. They will not have to stay in the hospital for this course.\n\nAbout 30 days after treatment ends, participants will have a safety follow-up visit. Then they will have visits every 3 months for up to 1 year, and then every 6 months for up to 4 years. Follow-up can also be done by phone, email, and mail. If their cancer gets worse, they will stop having visits.\n\nParticipation will last for 5 years....","conditions":["Metastatic Melanoma","Advanced Locoregional Melanoma","Metastatic Renal Cell Carcinoma","Clear Cell Histology"],"keywords":["Immunotherapy","Monoclonal Antibody"],"interventions":[{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Aldesleukin"}],"enrollment":78,"startDate":"2022-08-18","completionDate":"2031-09-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants must have histologically or cytologically confirmed cancer that falls into one of three cohorts: (1) metastatic melanoma or advanced locoregional melanoma not amenable to curative surgical resection and refractory to anti-PD-1 therapy; (2) metastatic renal cell carcinoma (clear cell histology) refractory to at least one line of PD1/PDL1 based therapy; (3) metastatic or advanced locoregional melanoma not amenable to curative surgical resection and naive to anti-PD-1 therapy.\n* Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer.\n* Age \\>=18 years of age.\n* Clinical performance status of ECOG 0 or 1.\n* Willing to practice birth control from the time of enrollment on this study and for four months after treatment.\n* Must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus.\n* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who are HIV seropositive may have decreased immune-competence and thus be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* Seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\> 1000/mm\\^3 without the support of filgrastim\n  * WBC \\>= 3000/mm\\^3\n  * Platelet count \\>= 100,000/mm\\^3\n  * Hemoglobin \\> 8.0 g/d (Subject may be transfused to reach this cut-off)\n  * Serum ALT/AST \\<= 5.0 x ULN\n  * Serum creatinine \\<= 1.6 mg/dL\n  * Total bilirubin \\<= 2.0 mg/dL, except in participants with Gilbert s Syndrome, who must have a total bilirubin \\< 3.0 mg/dL.\n* More than four weeks must have elapsed since completion of any prior systemic therapy at the time of enrollment.\n\nNote: Participant may have undergone minor surgical procedures or limited field radiotherapy within the four weeks prior to enrollment, as long as related major organ toxicities have recovered to \\<= grade 1.\n\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n* Willing to sign a Durable Power of Attorney Form.\n* Subject must be co-enrolled on protocol 03-C-0277\n\nEXCLUSION CRITERIA:\n\n* Participant is nursing because of the potentially dangerous effects of the treatment on the fetus or infant.\n* Concurrent systemic steroid therapy.\n* Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses.\n* Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS).\n* History of major organ autoimmune disease.\n* Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1 monotherapy, including but not limited to myocarditis, pneumonitis, colitis, and hepatotoxicity.\n* Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)\n* History of severe immediate hypersensitivity reaction to pembrolizumab or aldesleukin.\n* History of coronary revascularization or ischemic symptoms.\n* For select participants with a clinical history prompting cardiac evaluation: last known LVEF \\<= 45%.\n* For select participants with a clinical history prompting pulmonary evaluation: known FEV1 \\<= 50%.\n* Participant is receiving any other investigational agents.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI SB Immunotherapy Recruitment Center","phone":"(866) 820-4505","email":"irc@nih.gov"},{"name":"Stephanie L Goff, M.D.","phone":"(240) 760-6214","email":"stephanie.goff@nih.gov"}],"primaryOutcomes":["Response rate in treatment refractory disease"],"hasResults":false,"conditionSlugs":["melanoma","kidney-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Pembrolizumab for Metastatic Melanoma","inPlainEnglish":"Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma. Pembrolizumab is used to treat many cancers including melanoma.","whoItsFor":["Ages 18 Years to 120 Years","Participants must have measurable disease (per RECIST v1.1 criteria), metastatic melanoma or renal cell cancer","Age \\>=18 years of age","Clinical performance status of ECOG 0 or 1","Willing to practice birth control from the time of enrollment on this study and for four months after treatment","Must have a negative pregnancy test because of the potentially dangerous effects of the treatment on the fetus","Seronegative for hepatitis B antigen and for hepatitis C antibody. If hepatitis C antibody test is positive, then participant must be tested for the presence of antigen by RT-PCR and be HCV RNA negative","Participants must have adequate organ and marrow function as defined below:"],"whoShouldSkip":["Participant is nursing because of the potentially dangerous effects of the treatment on the fetus or infant","Concurrent systemic steroid therapy","Active systemic infections requiring anti-infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses","Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease and AIDS)","History of major organ autoimmune disease","Grade 3 or 4 major organ irAEs following treatment with anti-PD-1/PD-L1 this drug alone, including but not limited to myocarditis, pneumonitis, colitis, and hepatotoxicity","Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Participants who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities.)"],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, or Aldesleukin. The registry lists allocation as na. Background: Aldesleukin is used to treat metastatic or advanced melanoma and renal cell carcinoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 78 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.802Z"},{"nctId":"NCT05156112","title":"OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit","officialTitle":"Examining Early Intervention Obstructive Sleep Apnea Treatment on Long-Term Outcomes in Veterans With SUD/PTSD in a Residential Treatment Program","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings. Obstructive sleep apnea (OSA) is highly comorbid with both disorders and untreated OSA is associated with worse functional impairment across multiple domains, worse quality of life, worse PTSD, higher suicidal ideation, and higher substance use and relapse rates. Treating OSA with evidence-based positive airway pressure (PAP) in Veterans with SUD/PTSD on a residential unit is a logical way to maximize treatment adherence and treatment outcomes. This study compares OSA treatment while on a SUD/PTSD residential unit to a waitlist control group. The investigators hypothesize that treating OSA on the residential unit, compared to the waitlist control, will have better functional, SUD, and PTSD outcomes.","conditions":["Post Traumatic Stress Disorder","Obstructive Sleep Apnea","Substance Use Disorder","Residential Treatment Program"],"keywords":["Veteran","PTSD","Obstructive Sleep Apnea","Substance Use Disorder","PAP Treatment","Residential Treatment"],"interventions":[{"type":"DEVICE","name":"Positive Airway Pressure Device"}],"enrollment":194,"startDate":"2023-01-02","completionDate":"2027-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* a Veteran of the U.S. military or Reserve/National Guard member\n* have an Apnea Hypopnea Index (AHI) 5 per hour\n* experienced trauma that occurred in childhood or adulthood; at least one month post-trauma\n* have current DSM-5 diagnoses of substance use disorder (SUD) via Structured Clinical Interview for DSM-Substance Use Disorders (SCID-SUD) module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)\n* Full post-traumatic stress disorder (PTSD) diagnosis via clinician administered post-traumatic stress disorder (PTSD) scale\n* are literate in English\n* are on the post-traumatic stress disorder (PTSD) track of the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit\n* are capable of giving informed consent\n\nExclusion Criteria:\n\n* have central sleep apnea (Apnea Hypopnea Index (AHI)\\>=5 and \\> 50% central apneas)\n* arrives on the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit already using a positive airway pressure (PAP) device (Veteran's previously diagnosed with OSA, but not using positive airway pressure (PAP) therapy will be eligible)\n* the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via Montreal Cognitive Assessment (MOCA) \\< 26)\n* history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress","locations":[{"facility":"VA San Diego Healthcare System, San Diego, CA","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Peter Colvonen, PhD","phone":"(858) 552-8585","email":"peter.colvonen@va.gov"}],"primaryOutcomes":["Change in WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)","Change in Timeline Follow-Back (TLFB) % days drinking/using in last 90 days","Change in Clinician Administered PTSD Scale (CAPS-5)","Change in the Columbia-Suicide Severity Rating Scale (C-SSRS)"],"hasResults":false,"conditionSlugs":["ptsd","sleep-apnea"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: Positive Airway Pressure Device for Post Traumatic Stress Disorder","inPlainEnglish":"Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone. This is especially true in residential settings where both disorders are more severe than outpatient settings.","whoItsFor":["Ages 18 Years to any","a Veteran of the U.S. military or Reserve/National Guard member","have an Apnea Hypopnea Index (AHI) 5 per hour","experienced trauma that occurred in childhood or adulthood; at least one month post-trauma","have current DSM-5 diagnoses of substance use disorder (SUD) via Structured Clinical Interview for DSM-Substance Use Disorders (SCID-SUD) module with a minimum 20 days of substance use in the last 90 days (Timeline Follow-back)","Full post-traumatic stress disorder (PTSD) diagnosis via clinician administered post-traumatic stress disorder (PTSD) scale","are literate in English","are on the post-traumatic stress disorder (PTSD) track of the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit"],"whoShouldSkip":["have central sleep apnea (Apnea Hypopnea Index (AHI)\\>=5 and \\> 50% central apneas)","arrives on the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) unit already using a positive airway pressure (PAP) device (Veteran's previously diagnosed with OSA, but not using positive airway pressure (PAP) therapy will be eligible)","the Substance Abuse Residential Rehabilitation Treatment Program (SARRPT) medical staff advises against the study based on medical history and physical examination; d) history of severe cognitive impairment (via Montreal Cognitive Assessment (MOCA) \\< 26)","history of psychosis or mania independent of substance use will be excluded because the presence of these disorders can impede therapy progress"],"whatHappens":"If you join, the listed intervention(s) are Positive Airway Pressure Device. The registry lists allocation as randomized. Substance use disorder (SUD) and posttraumatic stress disorder (PTSD) frequently co-occur and having both disorders is associated with greater psychological and functional impairment than having either disorder alone.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 194 people at San Diego. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.416Z"},{"nctId":"NCT05156398","title":"Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \\<18 years with episodic migraine.","conditions":["Migraine"],"keywords":["Migraine","Migraine prevention","Phonophobia","Photophobia","Nausea","Pediatric migraine","Adolescent migraine"],"interventions":[{"type":"DRUG","name":"Rimegepant"},{"type":"DRUG","name":"Placebo"}],"enrollment":640,"startDate":"2022-02-28","completionDate":"2029-03-27","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:\n\n   1. 14 or less headache days per month during the 3 month period prior to the Screening Visit\n   2. 6 or more migraine days during the Observation Period\n   3. 14 or less headache days during the Observation Period\n   4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \\>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit\n   5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches\n   6. Migraine attacks, on average, lasting 4 - 72 hours if untreated\n   7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \\<18 years; subjects must be less than 18 at the time of signing assent / consent.\n\n      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.\n\nExclusion Criteria:\n\n1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine\n2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.\n3. The subject has a history or diagnosis of complications of migraine\n4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.\n5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.\n6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.\n7. History of major psychiatric disorder.\n8. The subject has a current diagnosis or history of substance abuse\n9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.","locations":[{"facility":"The Belinga Clinic","city":"Fort Smith","state":"Arkansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Advanced Investigative Medicine, Inc.","city":"Hawthorne","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research San Diego","city":"La Mesa","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Colorado Springs Neurological Associates","city":"Colorado Springs","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Advanced Neurosciences Research, LLC","city":"Fort Collins","state":"Colorado","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Washington DC","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites Network - 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Subjects with a lifetime history of psychosis and/or mania are excluded","History of suicidal behavior or the subject is at risk of self-harm or harm to others","History of major psychiatric disorder"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant, or Placebo. The registry lists allocation as randomized. This study wants to compare the how well it works and safety of rimegepant to dummy treatment (placebo) as a preventative treatment for migraine in children and adolescents ≥ 6 to \\<18 years with episodic migraine.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 640 people at 93 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.306Z"},{"nctId":"NCT05164172","title":"A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine","officialTitle":"Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"H. 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Lundbeck A/S","phone":"+45 36301311","email":"HQ_Medinfo@Lundbeck.com"}],"primaryOutcomes":["Number of Participants With Treatment Emergent Adverse Events"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","stamford-connecticut","gainesville-florida","gulf-breeze-florida","hialeah-florida","loxahatchee-groves-florida","tampa-florida","lexington-kentucky","baltimore-maryland","ann-arbor-michigan","grand-rapids-michigan","amherst-new-york","commack-new-york","charlotte-north-carolina","akron-ohio","cincinnati-ohio","san-antonio-texas","norfolk-virginia","huntington-west-virginia","milwaukee-wisconsin","mar-del-plata-argentina","buenos-aires-argentina","c-rdoba-argentina","r-o-cuarto-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","victoria-canada","ajax-canada","london-canada","cagliari-italy","genoa-italy","milan-italy","pavia-italy","pisa-italy","rome-italy","durango-mexico","guadalajara-mexico","tepetlacalco-mexico","chihuahua-city-mexico","krakow-poland","o-wi-cim-poland","lublin-poland","warsaw-poland","almada-portugal","braga-portugal","coimbra-portugal","porto-portugal","belgrade-serbia","novi-sad-serbia","kragujevac-serbia","ni-serbia","seville-spain","barcelona-spain","madrid-spain","eski-ehir-turkey-t-rkiye","izmir-turkey-t-rkiye","mersin-turkey-t-rkiye","edinburgh-united-kingdom","great-yarmouth-united-kingdom","glasgow-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Eptinezumab for Migraine","inPlainEnglish":"The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.","whoItsFor":["Ages 6 Years to 17 Years","\\- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study"],"whoShouldSkip":["The participant has an adverse event or other safety concerns that are deemed related to neither you nor the study doctors know who gets the real treatment treatment received in the lead-in study and is considered a potential safety risk by the investigator","During lead-in Study19356A or Study19357A:","participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator","the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value \\>5 times the upper limit of the reference range that was confirmed by testing \\<2 weeks later","the participant had a serum ALT or AST value \\>3times the upper limit of the reference range and a serum total bilirubin value \\>2times the upper limit of the reference range"],"whatHappens":"If you join, the listed intervention(s) are Eptinezumab. The registry lists allocation as randomized. The main goal of the study is to assess the long-term safety of eptinezumab on children and adolescents ages 6 to 17 with chronic or episodic migraine.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 64 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.305Z"},{"nctId":"NCT05169593","title":"Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy","officialTitle":"Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy: a Randomized, Multicentre, Parallel Group Pragmatic Non-inferiority Trial in Crohn Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Universitaire Ziekenhuizen KU Leuven","sponsorClass":"OTHER","summary":"With this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited.\n\nFinally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.","conditions":["Crohn Disease"],"keywords":["biological therapy","ileocolonoscopy","ileocolonic resection","ileocolonic anastomosis"],"interventions":[{"type":"DRUG","name":"Biological Drug"}],"enrollment":292,"startDate":"2022-09-08","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology\n3. Males and females 18-80 years old.\n4. Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit.\n\n   Patients who underwent an ileocolonic resection with ileocolonic anastomosis with a temporary ileostomy are also eligible if the ileocolonic resection was performed within eight months prior to the Screening visit, and the restoration of the faecal stream was performed within 3 and 40 days prior to the Screening visit.\n5. Patients having an increased risk for postoperative recurrence for any of the following reasons:\n\n   1. Penetrating disease as reason for ileocolonic resection\n   2. Previous ileocolonic resection within ten years of index surgery\n   3. Two or more previous ileocolonic resections\n   4. Active smoking\n   5. Biological therapy for Crohn's disease within 3 months of index ileocolonic resection\n6. Curative ileocolonic resection. All inflamed colon segments should have been removed. Strictureplasties in the small bowel not involving the anastomotic region are allowed.\n7. Patients previously failing at least three months of steroids and/or three months of immunosuppressive therapy, or showing intolerance or a real contraindication for any of these therapies.\n8. Patients able and willing to start and continue biological therapy, and this at the timepoint indicated through study randomization\n\nExclusion Criteria:\n\n1. Participant has a history of primary non response or secondary loss of response to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab..\n2. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n4. Participation in an interventional Trial with an Investigational Medicinal Product (IMP) or device.\n5. Patients initiating biological therapy for CD as part of another clinical trial or a medical need program.\n6. Patients not understanding Dutch, French, German or English.\n7. Patients with ulcerative colitis or inflammatory bowel disease type unclassified.\n8. Patients with an ileorectal anastomosis, or an ileal pouch-anal anastomosis.\n9. Patients with active perianal disease.\n10. Patients with a colorectal stenosis.\n11. Patients with an ostomy.\n12. Patients with sepsis or other postoperative complications necessitating the use of antibiotics for more than ten days after ileocolonic resection or restoration of the faecal stream.\n13. Patients with (an imminent risk) of a short bowel syndrome.\n14. Patients who had qualifying ileocolonic resection for dysplasia or cancer without ongoing inflammation.\n15. Patients with liver test abnormalities (aspartate transaminase, alanine transaminase, alkaline phosphatases, or bilirubin \\> 2 upper limit of normal), leukopenia (\\<3000 white blood cells 109/L, \\<1500 neutrophils 109/L ), thrombocytopenia (platelets \\< 50.000/mm3).\n16. Patients with severe renal, pulmonary or cardiac disease.\n17. Ongoing alcohol or substance abuse.","locations":[{"facility":"ZAS","city":"Antwerp","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZA","city":"Edegem","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus ziekenhuis","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint Luc","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel","city":"Jette","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHwapi","city":"Tournai","state":"Henegouwen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"ZOL Genk","city":"Genk","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHC 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Delta","city":"Roeselare","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitaz","city":"Sint-Niklaas","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Humanitas research hospital","city":"Milan","state":"Rozzano MI","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS De Bellis Castellana Grotte","city":"Castellana Grotte","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Careggi University Hospital","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS San Raffael Hospital","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marc Ferrante, Professor","phone":"016 342845","email":"marc.ferrante@uzleuven.be"},{"name":"Dorien Beeckmans, PhD","phone":"016 348545","email":"dorien.beeckmans@uzleuven.be"}],"primaryOutcomes":["postoperative endoscopic recurrence (Rutgeerts score ≥i2b)","need for unscheduled treatment adaptation prior to week 86"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["antwerp-belgium","edegem-belgium","brussels-belgium","jette-belgium","tournai-belgium","genk-belgium","li-ge-belgium","yvoir-belgium","ghent-belgium","leuven-belgium","bruges-belgium","ostend-belgium","aalst-belgium","bonheiden-belgium","brasschaat-belgium","hasselt-belgium","mechelen-belgium","roeselare-belgium","sint-niklaas-belgium","milan-italy","castellana-grotte-italy","florence-italy"],"enrichment":{"headline":"Phase 4: testing Biological Drug for Crohn Disease","inPlainEnglish":"With this prospective, randomly assigned, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious side effects, direct costs, work productivity, and quality of life.","whoItsFor":["Ages 18 Years to 80 Years","Patients with a diagnosis of Crohn's disease based on radiology, endoscopy and/or histology","Males and females 18-80 years old","Patients undergoing an ileocolonic resection with ileocolonic anastomosis (with or without temporary ileostomy) within 3 and 40 days prior to the Screening visit","Patients having an increased risk for postoperative recurrence for any of the following reasons:","Penetrating disease as reason for ileocolonic resection","Previous ileocolonic resection within ten years of index surgery","Two or more previous ileocolonic resections"],"whoShouldSkip":["Participant has a history of primary non response or secondary loss of response to all five biological therapies of interest, namely adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab.","Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol","Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial","Participation in an treatment Trial with an Investigational Medicinal Product (IMP) or device","Patients initiating biological therapy for CD as part of another clinical trial or a medical need program","Patients not understanding Dutch, French, German or English","Patients with ulcerative colitis or inflammatory bowel disease type unclassified"],"whatHappens":"If you join, the listed intervention(s) are Biological Drug. The registry lists allocation as randomized. With this prospective, randomly assigned, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 292 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.273Z"},{"nctId":"NCT05201781","title":"A Long-term Study for Participants Previously Treated With Ciltacabtagene Autoleucel","officialTitle":"Long-term Follow-up Study for Participants Previously Treated With Ciltacabtagene Autoleucel","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cilta-cel"}],"enrollment":295,"startDate":"2022-03-09","completionDate":"2037-07-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study\n* Participants who have provided informed consent for this study","locations":[{"facility":"Mayo Clinic Cancer 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Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School Of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert Memorial","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital Si Chuan University","city":"Chengdu","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fujian Medical University Union Hospital","city":"Fuzhou","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer Hospital","city":"Guangzhou","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"First Hospital, Zhejiang University Medical College","city":"Hangzhou","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School","city":"Nanjing","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital","city":"Nanjing","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Changzheng Hospital","city":"Shanghai","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital Shanghai Jiao Tong University","city":"Shanghai","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Fourth People s Hospital","city":"Shanghai","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xi'an Jiaotong University","city":"Xi'an","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Lille Hopital Claude Huriez","city":"Nord","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Saint Louis","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya City University Hospital","city":"Nagoya","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Medical Center","city":"Shibuya City","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"VU Medisch Centrum","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Groningen","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Univ. de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Clinico Univ de Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Participants with New Malignancies and Recurrence of Pre-existing Malignancy","Number of Participants with New Incidence or Exacerbation of a Pre-existing Neurologic Disorder","Number of Participants with New Incidence or Exacerbation of a Pre-existing Rheumatologic or Other Autoimmune Disorder","Number of Participants with New Incidence of Grade Greater than or Equal to (>=) 3 Hematologic Disorder Including Hypogammaglobulinemia","Number of Participants with Serious Hematologic Disorder, including Hypogammaglobulinemia","Number of Participants with New Incidence of Grade >= 3 Infection","Number of Participants with Serious Infection","Number of Participants with Serious Adverse Events (SAEs)","Number of Participants with Related Serious Adverse Events Assessed by the Investigator"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","duarte-california","san-francisco-california","stanford-california","tampa-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","westwood-kansas","boston-massachusetts","detroit-michigan","rochester-minnesota","st-louis-missouri","hackensack-new-jersey","new-brunswick-new-jersey","buffalo-new-york","new-york-new-york","the-bronx-new-york","charlotte-north-carolina","philadelphia-pennsylvania","pittsburgh-pennsylvania","nashville-tennessee","houston-texas","milwaukee-wisconsin","ghent-belgium","leuven-belgium","beijing-china","chengdu-china","fuzhou-china","guangzhou-china","hangzhou-china","nanjing-china","shanghai-china","xian-china","nord-france","paris-france","tel-aviv-israel","nagoya-japan","shibuya-city-japan","amsterdam-netherlands","groningen-netherlands","pamplona-spain","salamanca-spain"],"enrichment":{"headline":"Phase 4: testing Cilta-cel for Multiple Myeloma","inPlainEnglish":"This study wants to collect long-term follow-up data on delayed side effects after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.","whoItsFor":["Ages 18 Years to any","Participants who have received at least one dose of cilta-cel in a Company-sponsored clinical study"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Cilta-cel. The registry lists allocation as na. This study wants to collect long-term follow-up data on delayed side effects after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 295 people at 50 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.410Z"},{"nctId":"NCT05205109","title":"A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors","officialTitle":"A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Antengene Therapeutics Limited","sponsorClass":"INDUSTRY","summary":"This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors","conditions":["Locally Advanced or Metastatic Solid Tumors"],"keywords":[],"interventions":[{"type":"DRUG","name":"ATG-037"},{"type":"DRUG","name":"KEYTRUDA ®( Pembrolizumab)"}],"enrollment":98,"startDate":"2022-06-07","completionDate":"2027-08-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.\n2. Aged at least 18 years as of the date of consent.\n3. Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after at least one prior ICI containing treatment. Patients with mucosal and uveal melanoma types are to be excluded.\n4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. Estimated life expectancy of a minimum of 12 weeks.\n6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD\\>6 months).\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.\n8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.\n9. Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.\n10. Subjects should have adequate organ function.\n\nExclusion Criteria:\n\n1. Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.\n2. Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.\n3. Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).\n4. Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.\n5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids.\n6. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.\n7. Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.\n8. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.\n9. Subjects receiving unstable or increasing doses of corticosteroids.\n10. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.","locations":[{"facility":"Calvary Mater Newcastle","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pindara Private Hospital","city":"Benowa","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Oncology Clinical Research Unit","city":"Bedford Park","state":"South Australia","country":"Australia","status":"TERMINATED","lat":null,"lon":null},{"facility":"Peninsula & South Eastern Haematology and Oncology Group","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"One Clinical Research Pty Ltd","city":"Mount Pleasant","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing Cancer Hospital","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"TERMINATED","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"TERMINATED","lat":null,"lon":null},{"facility":"Beijing GoBroad Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sunny He","phone":"187 2152 1865","email":"sunny.he@antengene.com"},{"name":"Ting Liu","phone":"","email":"ting.liu@antengene.com"}],"primaryOutcomes":["Incidence of adverse events and server adverse events","DLT","MTD","RP2D"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["pembrolizumab"],"locationSlugs":["sydney-australia","benowa-australia","bedford-park-australia","frankston-australia","mount-pleasant-australia","chongqing-china","guangzhou-china","beijing-china"],"enrichment":{"headline":"Phase 1: testing ATG-037 for Locally Advanced or Metastatic Solid Tumors","inPlainEnglish":"This is a study of ATG-037 this drug alone and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors","whoItsFor":["Ages 18 Years to any","Aged at least 18 years as of the date of consent","Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after at least one prior ICI containing treatment. Patients with mucosal and uveal melanoma types are to be excluded","There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1","Estimated life expectancy of a minimum of 12 weeks","Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD\\>6 months)","Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature","Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding"],"whoShouldSkip":["Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis","Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor","Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days)","Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids","Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days","Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for side effects (CTCAE 5.0) Grade 1 at the time of ICF signature","Subjects receiving unstable or increasing doses of corticosteroids"],"whatHappens":"If you join, the listed intervention(s) are ATG-037, or KEYTRUDA ®( Pembrolizumab). The registry lists allocation as na. This is a study of ATG-037 this drug alone and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 98 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.625Z"},{"nctId":"NCT05207098","title":"A Study of Neurocognitive Tests and Questionnaires for People With Head and Neck Cancer Who Are Undergoing Radiation Therapy","officialTitle":"Pilot Study of Radiation-Associated Neurocognitive Function Among Head and Neck Cancer Patients","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.","conditions":["Head and Neck Cancer"],"keywords":["Neurocognitive function","Neurocognitive Tests","Questionnaires","21-498"],"interventions":[{"type":"OTHER","name":"Neurocognitive Tests"},{"type":"OTHER","name":"Questionnaires"}],"enrollment":185,"startDate":"2021-12-22","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"89 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically proven diagnosis of a head and neck cancer, specifically these subtypes: nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, or larynx/hypopharynx, oropharynx, cancer of unknown primary, or salivary gland.\n* Ages ≥ 18 and \\<89 at time of diagnosis.\n* Recently diagnosed with their initial head and neck cancer and able to be consented prior to OR within first week of starting standard of care radiation therapy.\n* Baseline simulation whole-brain MRI or CT available as part of standard of care.\n* Patients diagnosed with cancer, no distant metastases.\n* Karnofsky Performance Status of \\>= 70 or comparable ECOG performance at enrollment.\n* As per self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics) on a daily basis, dose must have been stable for at least two months prior to enrollment.\n* English fluent as per self-reported fluency of \"well' or \"very well\", and having a reasonable comprehension of the study conversation in the opinion of the research staff).\\*\\* \\*\\* Language verification: Prior to enrollment, all patients will be asked the following two questions by the CRC to verify English fluency necessary for participation in the study:\n\n  1. How well do you speak English?\n\n     Must respond \"Well\" or \"Very well\" when given the choices of:\n\n     Very well, Well, Not well, Not at all, Don't know, or Refused.\n  2. What is your preferred language for healthcare? Must respond English.\n\nExclusion Criteria:\n\n* Patients with multiple primary head and neck cancers, carcinoma of unknown primary, or recurrence.\n* Patients who previously received radiation therapy to the head and neck region as treatment for any prior cancer for any other non-cancerous condition.\n* Patients who had chemotherapy within two years prior to their recent diagnosis of head and neck cancer, such as patients who received chemotherapy as treatment for any other type of cancer or received neoadjuvant chemotherapy prior to surgery to treat their recent head and neck diagnosis. Patients who receive induction chemotherapy just prior to the start of their radiation therapy or receive concurrent chemotherapy to treat their recent head and neck diagnosis are allowed\n* At the discretion of the clinician, patients who are unable to comfortably speak due to symptoms of their cancer or treatment, such as surgery.\n* Pre-existing diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.).\n* As per medical record or self-report, history of stroke or head injury requiring medical care, confirmed structural lesion on neuroimaging, and persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation.\n* Pre-existing diagnosis of a Schizophrenia Spectrum Disorder, substance use disorder, Bipolar Disorder or Schizotypal personality disorder. Schizophrenia Spectrum Disorders include Schizophrenia, Schizophreniform disorder, Schizoaffective disorder, Delusional disorder, Brief psychotic disorder, and Attenuated Psychotic Disorder.\n* Pre-existing visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)","locations":[{"facility":"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","city":"Rockville Centre","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jonine Bernstein, PhD","phone":"646-888-8241","email":"bernstej@mskcc.org"},{"name":"Lawrence Dauer, PhD","phone":"212-639-5372","email":""}],"primaryOutcomes":["Number of newly diagnosed head and neck cancer patients recruited and retained on study"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","rockville-centre-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Neurocognitive Tests for Head and Neck Cancer","inPlainEnglish":"The researchers are doing this study to collect more information about if, and how, neurocognitive function may be affected in people being treated with radiation therapy for head and neck cancer. Part of this study is to see if patients diagnosed with head and neck cancer who are undergoing radiation therapy are able to complete neurocognitive testing and questionnaires at 3 times over a period of 1 year.","whoItsFor":["Ages 18 Years to 89 Years","Pathologically proven diagnosis of a head and neck cancer, specifically these subtypes: nasopharynx, maxillary sinus, tonsil, base of the tongue, oral cavity, or larynx/hypopharynx, oropharynx, cancer of unknown primary, or salivary gland","Ages ≥ 18 and \\<89 at time of diagnosis","Recently diagnosed with their initial head and neck cancer and able to be consented prior to OR within first week of starting standard of care radiation therapy","Baseline simulation whole-brain MRI or CT available as part of standard of care","Patients diagnosed with cancer, no distant metastases","Karnofsky Performance Status of \\>= 70 or comparable ECOG performance at enrollment","As per self-report, if currently taking psychoactive medications (excluding gabapentin and including but not limited to antidepressants, and anxiolytics) on a daily basis, dose must have been stable for at least two months prior to enrollment"],"whoShouldSkip":["Patients with multiple primary head and neck cancers, carcinoma of unknown primary, or recurrence","Patients who previously received radiation therapy to the head and neck region as treatment for any prior cancer for any other non-cancerous condition","At the discretion of the clinician, patients who are unable to comfortably speak due to symptoms of their cancer or treatment, such as surgery","Pre-existing diagnosis of neurodegenerative disorder that affects cognitive function (e.g. Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, Dementia, Seizure Disorders, etc.)","As per medical record or self-report, history of stroke or head injury requiring medical care, confirmed structural lesion on neuroimaging, and persistent cognitive difficulties impacting work or daily life or required cognitive rehabilitation","Pre-existing visual or auditory impairment that would preclude ability to complete the assessments (e.g. history of significant macular degeneration or being unable to correct hearing with hearing aids)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 185 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.020Z"},{"nctId":"NCT05213572","title":"Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies","officialTitle":"Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nPeople with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant. Researchers want to learn how and why this happens.\n\nObjective:\n\nTo study the benefits of treatments that are intended to cure SCD.\n\nEligibility:\n\nPeople aged 18 and older with SCD who are either receiving curative therapy in the next 3 months or don t have any plans to receive a curative therapy in the next 2 years.\n\nDesign:\n\nAt their first visit, participants will be screened with their medical history and a physical exam.\n\nParticipants will then have a baseline visit. This will take about a week to complete and will include:\n\nBlood and heart tests\n\nMRI of the brain, heart, and lungs. Participants will lie on a bed that will move into the MRI scanner. Special padding may be placed around their head to keep it still.\n\nInteractive games. Participants will complete computer games that test memory, attention, problem solving, language, spatial orientation, processing speed, and emotion.\n\nQuestionnaire rating quality of life\n\nIothalamate test. An IV catheter will be placed into a vein. A contrast agent will be injected through the IV. Blood will then be collected at different time points.\n\nLung function tests and a 6-minute walk test\n\nVibration controlled transient elastography. A probe placed on the abdomen will measure liver scarring.\n\nDOS test. A light attached to the finger or toe will measure blood oxygen.\n\nParticipants will have an end-of-study visit about 2 years after their baseline visit. This will include repeats of the baseline visit tests.","conditions":["Mortality in Sickle Cell","Sickle Cell Cardiopulmonary Complications","Sickle Cell Organ Damage","Sickle Cell Life Expectancy and Risk Factors for Early Death","Sickle Cell Lung Disease and Sudden Death"],"keywords":["Hydroxyurea","Hydroxyurea-Increased Fetal Hemoglobin","sickle cell anemi","Patterns of mortality in sickle cell disease","Mortality rates and age at death from sickle cell","Natural History"],"interventions":[],"enrollment":200,"startDate":"2022-03-24","completionDate":"2035-06-01","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or female, aged \\>=18 years\n3. Patients with current or previous diagnosis of any type of SCD (including HbSS, HbSC, HbSbeta\\^0-thal, HbSbeta\\^+-thal) who:\n\n   1. plan to receive an allogeneic HCT or gene therapy,\n\n      Or\n   2. are receiving non-curative treatment (standard of care or investigational) and who do not plan to receive an allogeneic HCT or gene therapy\n4. Ability to travel to the NIH Clinical Center\n5. Ability of subject to understand a written informed consent document.\n6. At least one of the following eligibility criteria:\n\n   * History of stroke (including silent stroke) or abnormal transcranial doppler examination (\\>= 200 m/s)\n   * Progression of central nervous system vasculopathy on MRA\n   * History of SCD-related renal insufficiency defined as nephrotic syndrome OR creatinine clearance \\< 60mL/min OR a creatinine level \\>=1.3 mg/dL AND kidney biopsy consistent with sickle cell nephropathy\n   * Tricuspid regurgitant velocity \\>= 2.5 m/s\n   * Recurrent tricorporal priapism defined as at least 2 episodes of an erection lasting \\> 4 hours involving the corpora cavernosa and corpus spongiosa\n   * SCD-associated liver disease defined as EITHER ferritin \\> 1000 mcg/L OR direct bilirubin \\> 0.4 mg/dL\n   * \\> 1 hospitalization per year for vaso-occlusive crises while receiving hydroxyurea treatment\n   * A history of 2 or more acute chest syndrome episodes in the participant's lifetime.\n   * Avascular necrosis of 2 or more joints\n   * Red cell alloimmunization (delayed hemolytic transfusion reaction or significant red blood cell alloimmunization that makes transfusion difficult).\n   * Administration of regular red blood cell (RBC) transfusion therapy (\\>=8 red cell transfusions in the previous 12 months) to prevent SCD complications (i.e. pain, stroke, or acute chest syndrome).\n   * Eligible for an allogeneic HCT or gene therapy at an outside transplant center.\n\nEXCLUSION CRITERIA:\n\nAll individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.\n\n1. Prior transplantation (including but not limited to HSCT and kidney transplant)\n2. Pregnant or breastfeeding\n3. Patients with allergy to iodine or iodinated contrast solutions will not undergo Iothalamate or Iohexol GFR clearance testing but can undergo the other deep phenotype testing\n4. Implanted metal object that is not compatible with MRI (e.g.: cerebral aneurysm clip, cochlear implant, or pacemaker)\n5. Patients with a pacemaker or automated implantable cardioverter defibrillator will not undergo VCTE but can enroll and undergo the other deep phenotype testing as long as the device is compatible with MRI and MRI testing can be performed\n6. Patients requiring peritoneal or hemodialysis\n7. Uncontrolled infection or acute illness","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julia M Varga, R.N.","phone":"(301) 402-3595","email":"julia.varga@nih.gov"},{"name":"Courtney F Joseph, M.D.","phone":"(301) 402-6496","email":"courtney.fitzhugh@nih.gov"}],"primaryOutcomes":["Change in LVEDV/BSA in patients with SCD who undergo curative therapies as compared to patients who receive non-curative treatment"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Observational Study to Deeply Phenotype Major Organs in Sickle Cell Disease After Curative Therapies","inPlainEnglish":"Background: People with sickle cell disease (SCD) have problems with their heart, brain, kidneys, liver, and lungs as they age. These problems may improve after transplant.","whoItsFor":["Ages 18 Years to 100 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged \\>=18 years","Patients with current or previous diagnosis of any type of SCD (including HbSS, HbSC, HbSbeta\\^0-thal, HbSbeta\\^+-thal) who:","plan to receive an allogeneic HCT or gene therapy,","are receiving non-curative treatment (standard of care or investigational) and who do not plan to receive an allogeneic HCT or gene therapy","Ability to travel to the NIH Clinical Center"],"whoShouldSkip":["All individuals meeting any of the"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.839Z"},{"nctId":"NCT05219617","title":"Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Carisbamate (YKP509) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults, With Optional Open-Label Extension","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"SK Life Science, Inc.","sponsorClass":"INDUSTRY","summary":"The primary objective is to evaluate the efficacy of carisbamate (YKP509) as adjunctive treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with placebo in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).","conditions":["Seizures","Lennox Gastaut Syndrome"],"keywords":["Seizures","Lennox Gastaut Syndrome","Pediatrics","Adults"],"interventions":[{"type":"DRUG","name":"Carisbamate"}],"enrollment":252,"startDate":"2022-04-28","completionDate":"2027-02","sex":"ALL","minAge":"4 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject must have a documented history of Lennox-Gastaut syndrome by:\n\n   1. Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure\n   2. History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \\<3.0 Hz)\n   3. History of developmental delay\n2. Male or female subjects\n3. Subjects must be age 4-55 years at the time of consent/assent\n4. Must have been \\<11 years old at the onset of LGS\n5. Subjects must have experienced at least 2 drop seizures with potential to fall (tonic, atonic, tonic-clonic) during the 4-week Baseline period preceding randomization (minimum of 4 drop seizures in the first two weeks and 4 in the last two weeks). Drop seizures are defined as a seizure involving the entire body, trunk, or head that led or could have led to a fall, injury, slumping in a chair, or hitting the subject's head on a surface. All drop seizure types must be countable (either as isolated seizures or as countable isolated seizures in a cluster).\n6. Subjects must have been receiving 1 to 4 concomitant anti-seizure medications (ASMs) at a stable dose for at least 4 weeks before Visit 1\n7. If not taking Epidiolex, subjects may take other approved cannabidiol or over the counter cannabidiol products. If taking cannabidiol other than Epidiolex, consult Medical Monitor to determine if it counts as a concomitant ASM.\n8. Dietary therapy and any CNS stimulator settings must be stable for 4 weeks prior to baseline and maintain stable regimen throughout the study. The dietary therapy and CNS stimulators are not counted as an ASM.\n9. Parents or caregivers must be able to keep accurate seizure diaries\n10. Subject is either not of childbearing potential, defined as premenarchal, postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), if of childbearing potential, must comply with an acceptable method of birth control during the study, for at least 4 weeks prior to study entry and for 4 weeks following completion of the study, if able.\n11. Subject and/or caregiver(s)/legal representative must be willing and able to give informed assent/consent for participation in the study\n12. Subject and their caregiver must be willing and able (in the investigator's opinion) to comply with all study requirements\n13. History of COVID-19 vaccination is permitted\n\nExclusion Criteria:\n\n1. Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor\n2. Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct\n3. Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline\n4. Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling\n5. Current use of felbamate with less than 18 months of continuous exposure\n6. Concomitant use of vigabatrin: subjects who took vigabatrin in the past must be discontinued for at least 5 months before Visit 1 and must have documentation showing no evidence of a vigabatrin-associated clinically significant abnormality in an automated visual perimetry test, if able.\n7. Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline\n8. Status epilepticus within 12 weeks prior to Visit 1\n9. Any clinically significant illness (including COVID-19) in the 4 weeks prior to Visit 1, as evaluated by the Investigator\n10. Subject has clinically significant abnormal laboratory values, in the investigator's opinion, at Visit 1 or time of randomization (Visit 2)\n11. Subject has a history of any serious drug-induced hypersensitivity, e.g., toxic epidermal necrolysis, or Drug Reaction with Eosinophilia and Systemic Symptoms \\[DRESS\\]) or any drug-related rash requiring hospitalization\n12. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), Responsive Neurostimulator System (RNS) or other neurostimulation for epilepsy device implanted or activated \\<5 months year prior to enrollment. Stimulation parameters that have been stable for \\<4 weeks, or Battery life of unit not anticipated to extend for duration of trial.\n13. Subject is pregnant, may be pregnant, lactating or planning to be pregnant\n14. Any suicidal ideation with intent, with or without a plan within 6 months before Visit 2 (i.e., answering \"Yes\" to questions 4 or 5 in the Suicidal Ideation section of the age- specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated\n15. Any suicidal behavior within 2 years before Visit 2 (i.e., answering YES to any question in the Suicidal behavior section of the age-specific Columbia-Suicide Severity Rating Scale (C-SSRS) in subjects aged 6 and above who are able to be evaluated.\n16. Evidence of significant active hepatic disease. Stable elevations of liver enzymes (alanine aminotransferase (ALT), and aspartate aminotransferase (AST)) due to concomitant medication(s) will be allowed if they are \\<3 x ULN\n17. Subject with total bilirubin \\[TBL\\] \\>2 x ULN (except for Gilbert's syndrome).\n18. Active viral hepatitis (B or C) as demonstrated by positive serology at the Screening visit (Visit 1)\n19. History of positive antibody/antigen test for human immunodeficiency virus (HIV)\n20. If taking Epidiolex, subject may not use other approved cannabidiol or over the counter cannabidiol products\n21. Scheduled for epilepsy-related surgery, VNS insertion, or any other stimulators/surgery during the projected course of the study\n22. Subject who has taken or used any investigational drug or device in the 4 weeks prior to the screening visit (Visit 1)\n23. Concomitant use of medications known to be strong inducers of cytochrome P450 (CYP3A) including, but not limited to: phenobarbital, phenytoin, carbamazepine, primidone, rifampin, troglitazone, St. John's Wort, efavirenz, nevirapine, glucocorticoids (other than topical usage), modafinil, pioglitazone, and rifabutin\n24. Evidence of cardiac disease, including unstable angina, myocardial infarction, within the past 2 years, uncontrolled heart failure, major arrhythmias, congenital short QT syndrome\n25. Subject with a short QTc interval (\\<340 msec) or long QTc interval (\\>460 msec) as confirmed by a repeated electrocardiogram (ECG)\n26. Benzodiazepine rescue administered on average more than once a week in the month before Visit 1\n27. Previous exposure to carisbamate or sensitivity/allergy to components of the oral suspension.","locations":[{"facility":"Stanford University Hospital","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida Health Science Center","city":"Jacksonville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"AdventHealth","city":"Orlando","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Pediatric Epilepsy and Neurology Specialists","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Axcess Medical Research","city":"Wellington","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Consultants in Epilepsy and Neurology PLLC","city":"Boise","state":"Idaho","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Bluegrass Epilepsy Research, LLC","city":"Lexington","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University Medical Center New Orleans","city":"New Orleans","state":"Louisiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-Atlantic Epilepsy and Sleep Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Missouri School of Medicine","city":"Columbia","state":"Missouri","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northeast Regional Epilepsy Group","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Peters Hospital","city":"New Brunswick","state":"New Jersey","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Montefiore","city":"The Bronx","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Duke University Clinical Research at Pickett Road","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University - School of Medicine","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Epilepsy Care Center - Clinic/Outpatient Facility","city":"Austin","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Neurology Consultants of Dallas, PA - Hospital","city":"Dallas","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Virginia Epilepsy and Neurodevelopmental Clinic at WNC","city":"Winchester","state":"Virginia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital de Ninos de La Santisma Trinidad","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Resolution Psychopharmacology Research Institute","city":"Mendoza","state":"Mendoza Province","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Austin Hosptial","city":"Heidelberg","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alfred Health","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perth's Children Hospital","city":"Nedlands","state":"","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Queensland Children's Hospital","city":"South Brisbane","state":"","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Fundacion Hospital Universidad del Norte","city":"Barranquilla","state":"","country":"Colombia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Fundacion Valle del Lili/Clinic - Outpatient","city":"Cali","state":"","country":"Colombia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"CliniSalud del Sur S.A.S - Centro de Investigación","city":"Envigado","state":"","country":"Colombia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Pabloe Tubon Uribe","city":"Medellín","state":"","country":"Colombia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Institutio Neurologico de Colombia","city":"Medellín","state":"","country":"Colombia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Universitatsklinikum Erangen","city":"Erlangen","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kleinwachau Sächsisches Epilepsiezentrum","city":"Radeberg","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iaso Children's Hospital","city":"Marousi","state":"Attica","country":"Greece","status":"COMPLETED","lat":null,"lon":null},{"facility":"Orszagos Mentalis, Ideggyogyaszati es Idegsebezeti Intezet","city":"Budapest","state":"","country":"Hungary","status":"COMPLETED","lat":null,"lon":null},{"facility":"Semmelweis Egyetem Idegsebeszeti es Neurointervencios Klinika","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tela Viv Sourlasky Medical Center","city":"Tel Aviv","state":"Tel Aviv","country":"Israel","status":"COMPLETED","lat":null,"lon":null},{"facility":"Soroka University Medical Centre","city":"Beersheba","state":"","country":"Israel","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"","country":"Israel","status":"COMPLETED","lat":null,"lon":null},{"facility":"Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN","city":"Genoa","state":"Liguria","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Fatebenefratelli Sacco - Ospedale dei Bambini Vittore Buzzi","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Di Rilievo Nazionale Instituto","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Integrata Di Verona","city":"Verona","state":"Verona","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN","city":"Florence","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"ASST Santi Paolo E Carlo - Azienda Universitaria-Polo Universitaria - San Paolo","city":"Milan","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Civil Fray Antonio Alcalde","city":"Guadalajara","state":"Jalisco","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurociencias Estudios Clinicos S.C.","city":"Culiacán","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinstile, S.A. de C.V.","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital Kliniczny im.H.Swiecickiego Uniwersytetu Medycznego im.K.Marcinkowskiego w Poznaniu-Dluga1/2","city":"Poznan","state":"Greater Poland Voivodeship","country":"Poland","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centrum Medyczne Plejady","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Hospitalar de Lisboa Norte, EPE","city":"Lisbon","state":"Lisbon District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Hospitalar de Lisboa Ocidental, EPE - Hospital Sao Francisco Xavier","city":"Lisbon","state":"Lisbon District","country":"Portugal","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centro Hospitalar de Sao Joao, EPE","city":"Porto","state":"Porto District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Garcia de Orta","city":"Almada","state":"Setúbal District","country":"Portugal","status":"COMPLETED","lat":null,"lon":null},{"facility":"Childrens University Hospital","city":"Belgrade","state":"Belgrade","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of Serbia - PPDS","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Nis","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children and Youth Health Care Institute of Vojvodina","city":"Novi Sad","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyungpook National University Chilgok Hospital","city":"Daegu","state":"","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Deu - PIN","city":"Esplugues de Llobregat","state":"Barcelona","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Infantil Universitario Niño Jesus - PIN","city":"Madrid","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Ruber Internacional (Grupo Quironsalud)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital","city":"Taoyuan","state":"","country":"Taiwan","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Barbara Remes","phone":"201-421-3810","email":"bremes@sklsi.com"}],"primaryOutcomes":["Primary outcome will be the percentage change from baseline in the total frequency (average per 28 days) of countable drop seizures with potential to fall (tonic, atonic, tonic-clonic) seizures during the double-blind treatment period."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["palo-alto-california","jacksonville-florida","orlando-florida","tampa-florida","wellington-florida","boise-idaho","lexington-kentucky","new-orleans-louisiana","baltimore-maryland","bethesda-maryland","rochester-minnesota","columbia-missouri","hackensack-new-jersey","new-brunswick-new-jersey","the-bronx-new-york","durham-north-carolina","winston-salem-north-carolina","philadelphia-pennsylvania","austin-texas","dallas-texas","winchester-virginia","c-rdoba-argentina","mendoza-argentina","heidelberg-australia","melbourne-australia","nedlands-australia","south-brisbane-australia","barranquilla-colombia","cali-colombia","envigado-colombia","medell-n-colombia","erlangen-germany","radeberg-germany","marousi-greece","budapest-hungary","tel-aviv-israel","beersheba-israel","jerusalem-israel","ramat-gan-israel","genoa-italy","milan-italy","verona-italy","florence-italy","guadalajara-mexico","culiac-n-mexico","mexico-city-mexico","poznan-poland","krakow-poland","lisbon-portugal","porto-portugal","almada-portugal","belgrade-serbia","kragujevac-serbia","ni-serbia","novi-sad-serbia","daegu-south-korea","seoul-south-korea","esplugues-de-llobregat-spain","madrid-spain","taipei-taiwan","taoyuan-taiwan"],"enrichment":{"headline":"Phase 3: testing Carisbamate for Seizures","inPlainEnglish":"The primary objective is to measure the how well it works of carisbamate (YKP509) as added on top of your current treatment treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with dummy treatment (placebo) in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).","whoItsFor":["Ages 4 Years to 55 Years","Subject must have a documented history of Lennox-Gastaut syndrome by:","Evidence of more than one type of seizure, of which at least one should be an atonic or tonic seizure","History of an electroencephalogram (EEG) reporting diagnostic criteria for LGS (abnormal background activity accompanied by slow, spike and wave pattern \\<3.0 Hz)","History of developmental delay","Male or female subjects","Subjects must be age 4-55 years at the time of consent/assent","Must have been \\<11 years old at the onset of LGS"],"whoShouldSkip":["Etiology of subject's seizures is a progressive neurologic disease. Subjects with tuberous sclerosis will not be excluded from study participation, unless there is a progressive brain tumor","Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease, hepatic disease) that in the opinion of the investigator(s) could affect the subject's safety or study conduct","Subjects who were on adrenocorticotropic hormone (ACTH) therapy in the 6 months prior to baseline","Subject on dietary therapy for less than 4 weeks prior to screening visit (Visit 1) or suffers from frequent stooling","Current use of felbamate with less than 18 months of continuous exposure","Subject who had a history of hypoxia which needed emergency resuscitation within 12 months prior to baseline","Status epilepticus within 12 weeks prior to Visit 1"],"whatHappens":"If you join, the listed intervention(s) are Carisbamate. The registry lists allocation as randomized. The primary objective is to measure the how well it works of carisbamate (YKP509) as added on top of your current treatment treatment in reducing the number of drop seizures (tonic, atonic, and tonic-clonic) compared with dummy treatment (placebo) in pediatric and adult subjects (age 4-55 years) diagnosed with Lennox Gastaut Syndrome (LGS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 252 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.901Z"},{"nctId":"NCT05222529","title":"Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glycopyrronium (Bromide) in Children (6 to Less Than 12 Years) With Asthma","officialTitle":"A Phase II, Double-blind, Randomized, Multiple Dose, Cross Over, Three-treatment, Three-period, Six Sequence Placebo Controlled Trial to Evaluate Efficacy, Pharmacokinetics (PK), Pharmacodynamics (PD) and Safety and Tolerability of Glycopyrronium (Bromide) in Children From 6 to Less Than 12 Years of Age With Asthma.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to placebo. Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.","conditions":["Asthma"],"keywords":["Glycopyrronium, pediatric, asthma, Breezhaler, PK"],"interventions":[{"type":"DRUG","name":"Glycopyrronium bromide 25ug"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Glycopyrronium bromide 12.5ug"}],"enrollment":42,"startDate":"2022-08-29","completionDate":"2027-07-30","sex":"ALL","minAge":"6 Years","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of asthma for at least 6 months\n* Signed informed consent by parent(s)/legal guardian(s) and assent by the pediatric participant (depending on local requirements)\n* Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in\n* Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the End of Run-in (Visit 30), the visit can be rescheduled once within 5 days from the previous attempt.\n* FEV1 reversibility, done using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in visit (Visit 20): increase \\> and/or = 12% (performed according to American Thoracic Society (ATS)/European Respiratory Society (ERS) 2019 guidelines). All participants must perform a reversibility test at start of Run-in. If reversibility is not demonstrated at Run-in, it may be attempted at up to two ad hoc, unscheduled separate visits within 5 days from previous attempt. If reversibility is still not demonstrated after repeated assessment participants must be screen failed\n* Demonstrated acceptable inhaler use technique for Diskus/Accuhaler (prior to run-in) and Breezhaler (prior to randomization) and able to complete spirometry procedures prior to randomization.\n* A parent/legal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the participant.\n* Parents/legal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic participant diary\n* Female participants of child-bearing potential, who might become sexually active, must be informed of the need to prevent pregnancy during the study using effective contraceptive methods. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.\n\nExclusion Criteria:\n\n* Systemic corticosteroid use for any reason within 3 months of Run-in\n* Participants on low to medium mono ICS alone\n* Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and/or in the four weeks prior to the Run-in visit\n* Participants who have had an asthma attack/exacerbation requiring a) systemic corticosteroids (SCS) or b) hospitalization or c) emergency room visit, within 3 months prior to Screening (Visit 1), or more than 3 separate exacerbations in the 12 months preceding the Screening visit\n* Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)\n* Participants with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in and confirmed at Baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened)\n* Suspected or documented active infections (bacterial, viral, fungal, mycobacterial or other, including active SARS-CoV-2, tuberculosis or atypical mycobacterial disease) of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 6 weeks of Screening (Visit 1)\n* History of Type I diabetes or uncontrolled Type II diabetes\n* Participants who are sexually active at screening\n* Hemoglobin levels outside normal ranges at Run-in (Visit 20)\n* Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if they become sexually active during study participation, do not agree to the use of contraception as defined in the inclusion criteria.\n\nAdditional protocol-defined inclusion / exclusion criteria may apply.","locations":[{"facility":"Novartis Investigative Site","city":"Rousse","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sevlievo","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ibague","state":"Tolima Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guatemala City","state":"GTM","country":"Guatemala","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guatemala City","state":"","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Debrecen","state":"Hajdu Bihar Megye","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Eger","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kaposvár","state":"","country":"Hungary","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nagykanizsa","state":"","country":"Hungary","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Szigetvár","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tarnów","state":"Poland","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"George","state":"Western Cape","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Cape Town","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Esplugues","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sabadell","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Mérida","state":"Extremadura","country":"Spain","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Stoke-on-Trent","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Change from Baseline in trough FEV1"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["rousse-bulgaria","sevlievo-bulgaria","sofia-bulgaria","ibague-colombia","guatemala-city-guatemala","debrecen-hungary","budapest-hungary","eger-hungary","kaposv-r-hungary","nagykanizsa-hungary","szigetv-r-hungary","tarn-w-poland","lodz-poland","george-south-africa","cape-town-south-africa","esplugues-spain","sabadell-spain","m-rida-spain","barcelona-spain","london-united-kingdom","stoke-on-trent-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Glycopyrronium bromide 25ug for Asthma","inPlainEnglish":"This study wants to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to dummy treatment (placebo). Outcome of this study will be used to determine the dose of inhaled glycopyrronium for the development of fixed dose combination indacaterol/mometasone/glycopyrronium (QVM149) for children aged 6 to less than 12 years old with moderate to severe asthma.","whoItsFor":["Ages 6 Years to 11 Years","Confirmed diagnosis of asthma for at least 6 months","Participant on stable dose of inhaled low-to-medium dose ICS with one additional controller for at least 4 weeks prior to run-in","Pre-Bronchodilator FEV1 ≥60% to ≤90% of predicted normal at beginning of Run-in and randomization. If FEV1 eligibility criteria are not met at -45min pre-dose of the End of Run-in (Visit 30), the visit can be rescheduled once within 5 days from the previous attempt","Demonstrated acceptable inhaler use technique for Diskus/Accuhaler (prior to run-in) and Breezhaler (prior to randomization) and able to complete spirometry procedures prior to randomization","A parent/legal guardian must be designated to complete all e-Diary entries and attend all clinic visits with the participant","Parents/legal guardian must be willing and able to assist the child with the procedures outlined in the protocol, e.g. compliance with study medication, completion of electronic participant diary"],"whoShouldSkip":["Systemic corticosteroid use for any reason within 3 months of Run-in","Participants on low to medium mono ICS alone","Participants requiring six or more puffs of rescue medication per day on more than two consecutive days in the four weeks prior to Screening (Visit 1) and/or in the four weeks prior to the Run-in visit","Participants with a known narrow-angle glaucoma, bladder dysfunction, bladder outlet obstruction or any other conditions where anticholinergic treatment is contraindicated prior to Screening (Visit 1)","History of Type I diabetes or uncontrolled Type II diabetes","Participants who are sexually active at screening","Hemoglobin levels outside normal ranges at Run-in (Visit 20)"],"whatHappens":"If you join, the listed intervention(s) are Glycopyrronium bromide 25ug, Placebo, or Glycopyrronium bromide 12.5ug. The registry lists allocation as randomized. This study wants to characterize the bronchodilator effect, systemic exposure and safety/tolerability of two different doses of inhaled glycopyrronium, when compared to dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 42 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.337Z"},{"nctId":"NCT05237986","title":"Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy","officialTitle":"Investigation of the Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic Malignancies Who Receive CAR T-cell Therapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nCAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells. Researchers want to learn more about the effects of potential problems that may be associated with this treatment. We are specifically interested in learning if and how this treatment may affect the brain or your thinking skills.\n\nObjective:\n\nTo learn if CAR T-cell therapy can affect how children and adults think, process, and remember things.\n\nEligibility:\n\nPeople aged 5-35 who have blood cancer that has not responded to treatment, or the blood cancer has come back after treatment, and who will receive CAR T-cell therapy. Caregivers are also needed. All participants must be able to speak and read in English or Spanish.\n\nDesign:\n\nParticipants will be screened with a medical history.\n\nInformation from participants medical records will be collected.\n\nParticipants will take tests at home or at NIH to see how well they think, read, learn, remember, reason, and pay attention. The tests will be both computerized and paper/pencil. They will take less than 1 hour to complete.\n\nParticipants and a parent/adult observer will complete a 5-minute Background Information Form and a checklist of nervous system symptoms.\n\nIf participants are 5 years or older, they will participate in activities to test their ability to do different thinking tasks, like answer questions, complete puzzle patterns, and remember things.\n\nParticipants and their caregivers will complete questions to see if they are having specific symptoms related to receiving CAR T-cells. The questions will assess their well-being and needs. The questions will take less than 1 hour to complete.\n\nSome tests and questions will be repeated at different time points in the study.\n\nParticipation will last for up to 3 years.","conditions":["Lymphoma","Leukemia"],"keywords":["Cogstate","Memory","Leukemia","Lymphoma","Natural History"],"interventions":[],"enrollment":60,"startDate":"2025-06-23","completionDate":"2028-09-01","sex":"ALL","minAge":"5 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants with disease\n\n  * Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites\n  * For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed.\n  * Age \\>= 5 and \\<=35 years old\n  * Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study\n  * Participants (\\<18 years, or \\>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations\n  * Participant must be able to speak and understand English or Spanish\n  * Participants must have access to a computer or tablet with a camera and an internet connection\n  * Participant or parent/guardian must be able to understand and willing to sign a written consent document\n* Caregivers (informants)\n\n  * Participants must be able to speak and read in English or Spanish\n  * Participants who are caregivers for participants with disease addressed above\n  * Age \\>= 18 years old\n  * Participants must have access to a computer or tablet\n  * Participants (of children \\<18 years, or \\>18 years if needed) must be willing to help set up an appropriate test environment for the remote evaluations\n  * Participant is able to understand and willing to sign a written consent document\n\nEXCLUSION CRITERIA:\n\n-Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)","locations":[{"facility":"Children s Hospital of Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children s Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Ped LeukemiaLymph Cell Tx Tm","phone":"(240) 760-6970","email":"ncilltct@mail.nih.gov"},{"name":"Pamela L Wolters, Ph.D.","phone":"(240) 760-6035","email":"woltersp@mail.nih.gov"}],"primaryOutcomes":["To evaluate changes in working memory in children and young adults with relapsed/refractory leukemia or lymphoma at 12 months post CAR T-cell therapy"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","bethesda-maryland","seattle-washington"],"enrichment":{"headline":"Cognitive Aftereffects of Neurotoxicity in Children and Young Adults With Relapsed/Refractory Hematologic M…","inPlainEnglish":"Background: CAR T-cell therapy is a promising new treatment for blood cancers. During treatment, a person s T-cells are genetically changed to kill cancer cells.","whoItsFor":["Ages 5 Years to any","Participants with disease","Participants are diagnosed with relapsed/refractory leukemias or lymphomas, and are scheduled to receive CAR T-cell treatment in one of the enrolling sites","For participants enrolled on a CAR T-cell treatment protocol, data sharing for the purposes of this study must be allowed","Age \\>= 5 and \\<=35 years old","Participant must have an eligible caregiver (informant) who is willing to complete assessments about the participant of this study","Participants (\\<18 years, or \\>=18 years if needed) must have an eligible caregiver to assist with setting up an appropriate test environment for the remote evaluations","Participants must have access to a computer or tablet with a camera and an internet connection"],"whoShouldSkip":["Participants with disease who have a pre-existing global intellectual disability (e.g., Down Syndrome)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.838Z"},{"nctId":"NCT05245695","title":"Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)","officialTitle":"Deep Neural Network Stratification for the Use in Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Aspira Women's Health","sponsorClass":"INDUSTRY","summary":"The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - \"EndoCheck\" - as an \"aid in diagnosis\" for endometriosis and to show validity as a diagnostic test","conditions":["Endometriosis"],"keywords":["Endometriosis","Biomarkers","Deep neural network"],"interventions":[{"type":"OTHER","name":"Observational study, no intervention"}],"enrollment":1200,"startDate":"2022-07-12","completionDate":"2026-11-30","sex":"FEMALE","minAge":"14 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is willing and able to provide written informed consent.\n* Participant is a female aged 14 to 50 years old at time of consent.\n* Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis\n\nExclusion Criteria:\n\n* Participant is a female in a pre-menarchal state.\n* Participant is pregnant.\n* Participant has an active malignancy.\n* Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.\n* Participant has an active pelvic infection or other infections contraindicated for surgery.\n* Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.\n* Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.\n* Participant is under 14 years old or over 50 years old","locations":[{"facility":"New Horizons Clinical Trials","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velvet Clinical Research","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Reproductive Associates of Delaware (RAD)","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midtown OBGYN North","city":"Columbus","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Women's Care Center","city":"Stockbridge","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cindy Basinski, MD","city":"Forest Hill","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins School of Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nezhat Surgery for Gynecology/Oncology","city":"Valley Stream","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seven Hills Clinical Research","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Womens Health Services of Central Virginia","city":"Lynchburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marla Then, CRC","phone":"844-277-4721","email":"mthen@aspirawh.com"},{"name":"Silvana Franco","phone":"","email":"sfranco@aspirawh.com"}],"primaryOutcomes":["Sensitivity and Specificity"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["chandler-arizona","burbank-california","newark-delaware","columbus-georgia","stockbridge-georgia","forest-hill-indiana","baltimore-maryland","valley-stream-new-york","cincinnati-ohio","lynchburg-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Observational study, no intervention for Endometriosis","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - \"EndoCheck\" - as an \"aid in diagnosis\" for endometriosis and to show validity as a diagnostic test","whoItsFor":["Ages 14 Years to 50 Years","Women only","Participant is a female aged 14 to 50 years old at time of consent","Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis"],"whoShouldSkip":["Participant is a female in a pre-menarchal state","Participant is pregnant","Participant has an active malignancy","Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C","Participant has an active pelvic infection or other infections contraindicated for surgery","Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered","Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,200 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.109Z"},{"nctId":"NCT05263206","title":"Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)","officialTitle":"Master Protocol of Two Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Studies to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Chronic Pruritus of Unknown Origin (CPUO)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The main objective of the study is to assess efficacy and safety of dupilumab given up to 24 weeks in adults with CPUO.\n\nThis is a master protocol which includes 2 parallel-treatment, double-blind, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO. Study B design was to be adapted based on the results of Study A.\n\nFor both Study A and B, after an up-to-4-week screening period, participants with severe pruritus (worst-itch numerical rating scale \\[WI-NRS ≥7) will enter a 4-week run-in period and will be treated with a non-sedative antihistamine and an emollient (moisturizer). Participants with severe pruritus (WI-NRS ≥7) at baseline will be randomized (1:1) to be treated for 24 weeks with either dupilumab or matching placebo in addition to their non-sedative antihistamine and emollient regimen. The treatment period for both study A and B will be followed by a 12-week follow-up period.","conditions":["Pruritus"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Fexofenadine (loratadine if not available)"}],"enrollment":284,"startDate":"2022-02-15","completionDate":"2027-06-02","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 90 years of age inclusive, at the time of signing the informed consent.\n* Participants with chronic pruritus for at least 6 months before the screening visit.\n* Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs).\n* Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk.\n* History of insufficient control of the chronic pruritus with prior treatment.\n* Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency).\n* Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored \"severe\" at screening.\n* Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS.\n* Participants scored \"severe\" in the PGIS of pruritus on Day 1.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study.\n* Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent.\n* Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit.\n* HIV infection.\n* Severe renal failure (dialysis).\n* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit.\n* Known or suspected immunodeficiency.\n* Active malignancy or history of malignancy within 5 years before the baseline visit, except completely treated in situ carcinoma of the cervix and completely treated and resolved non metastatic squamous or basal cell carcinoma of the skin.\n* History of hypersensitivity or intolerance to non-sedative antihistamines.\n* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Kern Allergy and Medical Research- Site Number : 8400016","city":"Bakersfield","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Modena Allergy + Asthma- Site Number : 8400038","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FoxHall Dermatology- Site Number : 8400042","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palm Harbor Dermatology- Site Number : 8400024","city":"Belleair","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Hospital- Site Number : 8400011","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Care Physicians of Georgia - Macon- Site Number : 8400030","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aeroallergy Research Laboratory- Site Number : 8400036","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Treasure Valley Medical Research- Site Number : 8400049","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Research- Site Number : 8400007","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Specialists Research (DS Research) - Kentucky- Site Number : 8400031","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tulane University School of Medicine- Site Number : 8400045","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital- Site Number : 8400020","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Asthma and Allergy Center- Site Number : 8400014","city":"Bellevue","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai - Union Square- Site Number : 8400034","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AXIS Clinicals - Fargo- Site Number : 8400037","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optima Research - Boardman- Site Number : 8400039","city":"Boardman","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia Dermatology & Aesthetics- Site Number : 8400047","city":"Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Allergy and Asthma Research- Site Number : 8400032","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complete Dermatology - Site Number : 8400046","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320004","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320008","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320005","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320001","city":"Buenos Aires","state":"","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320006","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320007","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320002","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320003","city":"Buenos 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1240005","city":"Montreal","state":"Quebec","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240004","city":"Verdun","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560003","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560004","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560009","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560006","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560005","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560002","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560001","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560011","city":"Suzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560008","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500001","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500003","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500004","city":"Reims","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760005","city":"Bad Bentheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760002","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760004","city":"Frankfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760003","city":"Mainz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760001","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480001","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480009","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480005","city":"Debrecen","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480010","city":"Gyula","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480003","city":"Szeged","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480011","city":"Székesfehérvár","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3480002","city":"Zalaegerszeg","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria di Ferrara-Site Number : 3800007","city":"Cona","state":"Ferrara","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AUSL Toscana Centro - Presidio Ospedaliero \"Piero Palagi-\"Site Number : 3800005","city":"Florence","state":"Firenze","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico-Site Number : 3800003","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800002","city":"Rozzano","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800006","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Site Number : 3800001","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria delle Marche-Site Number : 3800004","city":"Ancona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920009","city":"Matsudo","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920007","city":"Urayasu","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920006","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920008","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920004","city":"Habikino","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920002","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920005","city":"Izumo","state":"Shimane","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920001","city":"Tachikawa","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6160001","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6160007","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6160003","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6160008","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6160005","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100003","city":"Busan","state":"Busan","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100004","city":"Ansan-si","state":"Gyeonggi-do","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100005","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100002","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100006","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100001","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 4100007","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240003","city":"Barcelona","state":"Catalunya [Cataluña]","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240006","city":"Barcelona","state":"Catalunya [Cataluña]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240001","city":"Pontevedra","state":"Pontevedra [Pontevedra]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240005","city":"Alicante","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240004","city":"Córdoba","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1580003","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1580004","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1580001","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1580002","city":"Taoyuan City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free number for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Study A: Proportion of participants with improvement (reduction) in weekly average of daily worst-itch numerical rating scale (WI-NRS) by ≥4 from baseline to Week 24","Study B: Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["bakersfield-california","la-jolla-california","washington-d-c-district-of-columbia","belleair-florida","miami-florida","macon-georgia","savannah-georgia","boise-idaho","indianapolis-indiana","louisville-kentucky","new-orleans-louisiana","baltimore-maryland","bellevue-nebraska","new-york-new-york","fargo-north-dakota","boardman-ohio","columbia-south-carolina","north-charleston-south-carolina","sugar-land-texas","rosario-argentina","buenos-aires-argentina","calgary-canada","edmonton-canada","london-canada","markham-canada","toronto-canada","montreal-canada","verdun-canada","beijing-china","chengdu-china","chongqing-china","guangzhou-china","hangzhou-china","shanghai-china","suzhou-china","wuhan-china","brest-france","nice-france","reims-france","bad-bentheim-germany","berlin-germany","frankfurt-germany","mainz-germany","m-nster-germany","budapest-hungary","debrecen-hungary","gyula-hungary","szeged-hungary","sz-kesfeh-rv-r-hungary","zalaegerszeg-hungary","cona-italy","florence-italy","milan-italy","rozzano-italy","naples-italy","rome-italy","ancona-italy","matsudo-japan","urayasu-japan","sapporo-japan","yokohama-japan","habikino-japan","sakai-japan","izumo-japan","tachikawa-japan","krakow-poland","wroclaw-poland","warsaw-poland","busan-south-korea","ansan-si-south-korea","seoul-south-korea","barcelona-spain","pontevedra-spain","alicante-spain","c-rdoba-spain","kaohsiung-city-taiwan","new-taipei-city-taiwan","taipei-taiwan","taoyuan-city-taiwan"],"enrichment":{"headline":"Phase 3: testing Dupilumab for Pruritus","inPlainEnglish":"The main objective of the study is to assess how well it works and safety of dupilumab given up to 24 weeks in adults with CPUO. This is a master protocol which includes 2 parallel-treatment, neither you nor the study doctors know who gets the real treatment, 2- arm Phase 3 staggered studies of similar design (Study A and Study B) in male and female participants aged 18 to 90 years with CPUO.","whoItsFor":["Ages 18 Years to 90 Years","Participants with chronic pruritus for at least 6 months before the screening visit","Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (excluding chronic pruritus secondary to dermatological or systemic conditions, of neuropathic or psychogenic origin or secondary to drugs)","Chronic pruritus must affect at least 2 of the following body areas: legs, arms, or trunk","History of insufficient control of the chronic pruritus with prior treatment","Participants should receive optimal treatment for concomitant conditions that could impact pruritus (eg, diabetes, iron deficiency)","Participants must have a history of severe itch and a worst itch score of ≥7 at screening on the WI-NRS (score scale ranges from 0 to 10; higher score indicates worse itch) and Patient Global Impression of Severity (PGIS) of pruritus scored \"severe\" at screening","Participants must have an average worst itch score of ≥7 in the 7 days prior to run-in visit and in the 7 days prior to Day 1 on the WI-NRS"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the patient's participation in the study","Patients with active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis, unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent","Diagnosed with, suspected of, or at high risk of endoparasitic infection, and/or use of antiparasitic drug within 2 weeks before the screening visit","Severe renal failure (dialysis)","Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the run-in visit","Known or suspected immunodeficiency"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, Placebo, or Fexofenadine (loratadine if not available). The registry lists allocation as randomized. The main objective of the study is to assess how well it works and safety of dupilumab given up to 24 weeks in adults with CPUO.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 284 people at 94 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.705Z"},{"nctId":"NCT05266144","title":"Atrial Fibrillation Patients Treated With Catheter Ablation","officialTitle":"A Prospective Cohort Study of Atrial Fibrillation Patients Treated With Catheter Ablation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Peking Union Medical College Hospital","sponsorClass":"OTHER","summary":"This is a single-center prospective observational cohort study of atrial fibrillation patients treated with radiofrequency ablation.","conditions":["Atrial Fibrillation","Atrial Fibrillation Recurrent"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"radiofrequency ablation"}],"enrollment":300,"startDate":"2020-09-04","completionDate":"2027-10-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation\n* 18-80 years old\n* The anteroposterior diameter of the left atrium is less than 50mm via TTE\n* Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists\n* Patient consents to ablation treatment\n\nExclusion Criteria:\n\n* Intra-atrial thrombus detected by TEE\n* Hyperthyroidism\n* Previous radiofrequency ablation for atrial fibrillation","locations":[{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yongtai Liu, M.D.","phone":"+86-1069155068","email":"ataiever@163.com"}],"primaryOutcomes":["Recurrence assessed by ECG, Holter reports and outpatient physicians","All-cause mortality assessed by telephone follow-up or medical records"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: radiofrequency ablation for Atrial Fibrillation","inPlainEnglish":"This is a single-center prospective watch-and-measure (no experimental treatment required) cohort study of atrial fibrillation patients treated with radiofrequency ablation.","whoItsFor":["Ages 18 Years to 80 Years","Non-valvular atrial fibrillation, including paroxysmal atrial fibrillation and persistent atrial fibrillation","The anteroposterior diameter of the left atrium is less than 50mm via TTE","Patient meets the intervention criteria for bilateral pulmonary vein isolation after evaluation by electrophysiological specialists","Patient consents to ablation treatment"],"whoShouldSkip":["Intra-atrial thrombus detected by TEE","Previous radiofrequency ablation for atrial fibrillation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Beijing. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.745Z"},{"nctId":"NCT05270733","title":"Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics","officialTitle":"Development of Predictive Psoriasis Response Endotypes Using Single Cell Transcriptomics in Ustekinumab Responders Versus Non-responders","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospitals Cleveland Medical Center","sponsorClass":"OTHER","summary":"The investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed. The ability to rule out (or in) specific therapeutics based on predictive efficacy would lead to a more personalized approach for psoriasis treatment.\n\nTo do this, the investigators will be asking participants to try two different already on the market FDA-approved psoriasis drugs for 8 weeks at a time. The investigators will be monitoring participants skin for improvements as well as taking blood and skin samples at least three times. Investigators may also ask to take stool samples and/or skin swabs.","conditions":["Psoriasis"],"keywords":["ustekinumab","guselkumab","risankizumab","psoriasis"],"interventions":[{"type":"DRUG","name":"Ustekinumab"}],"enrollment":56,"startDate":"2022-11-10","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"89 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with plaque-type psoriasis defined by either:\n\n  * A board-certified dermatologist, OR\n  * Dermatology Nurse Practitioner, OR\n  * Skin punch biopsy\n* Insurance that includes an anti-p40 biologic (ustekinumab/.Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)\n* Must be naive to ustekinumab, guselkumab, and risankizumab.\n* Involvement of body surface area (BSA) of at least 10% at screening and baseline visit.\n* Able to give informed consent under IRB approval procedures\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study.\n* Inability to provide informed consent\n* Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial\n* Use of tanning booths for at least 4 weeks prior to baseline visit\n* Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit and for duration of trial\n* Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit\n* Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease).","locations":[{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy Johnson, MD","phone":"216-286-7369","email":"Amy.Johnson@UHhospitals.org"},{"name":"Amanda Davies, MBA","phone":"216-844-7834","email":"Amanda.Davies@UHhospitals.org"}],"primaryOutcomes":["Identification of a unique differentially expressed gene set in patients with psoriasis that may predict disease response following antagonism to IL-12 and/or IL-23."],"hasResults":false,"conditionSlugs":["als","psoriasis"],"drugSlugs":["risankizumab"],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Phase 4: testing Ustekinumab for Psoriasis","inPlainEnglish":"The investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed. The ability to rule out (or in) specific therapeutics based on predictive how well it works would lead to a more personalized approach for psoriasis treatment.","whoItsFor":["Ages 18 Years to 89 Years","Diagnosed with plaque-type psoriasis defined by either:","A board-certified dermatologist, OR","Dermatology Nurse Practitioner, OR","Insurance that includes an anti-p40 biologic (ustekinumab/.Stelara) and at least one anti-p19 biologic (guselkumab/Tremfya or risankizumab/Skyrizi)","Must be who have not tried this kind of treatment before to ustekinumab, guselkumab, and risankizumab","Involvement of body surface area (BSA) of at least 10% at screening and baseline visit"],"whoShouldSkip":["Pregnant, breastfeeding, or planning to get pregnant 8 weeks before, during, and 8 weeks after the study","Inability to secure ustekinumab and either gusekumab or risankizumab for use while on trial","Use of tanning booths for at least 4 weeks prior to baseline visit","Current or recent use of topical steroid, tar, phototherapy, Vitamin D, or retinoid therapy to target lesions for at least 2 weeks prior to baseline visit and for duration of trial","Current or recent use of systemic or biologic therapy for at least 8 weeks prior to baseline visit","Patients with psoriatic arthritis or other rheumatologic diseases (e.g., Crohn's disease)"],"whatHappens":"If you join, the listed intervention(s) are Ustekinumab. The registry lists allocation as na. The investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 56 people at Cleveland. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.584Z"},{"nctId":"NCT05299814","title":"Impact of Parental Emotion Regulation on the Treatment of ADHD","officialTitle":"The Impact of Parental Emotion Regulation Capacity on Behavioral Treatment for Pediatric ADHD","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Milton S. Hershey Medical Center","sponsorClass":"OTHER","summary":"Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions.\n\nH1: Reduced parental ER capacity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.\n\nH2: Increased parental emotional reactivity will predict diminished efficacy for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.","conditions":["ADHD"],"keywords":["oppositional behaviors, conduct problems"],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral Parenting Intervention"}],"enrollment":65,"startDate":"2017-04-13","completionDate":"2027-06-30","sex":"ALL","minAge":"5 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Parent of a child ages 5-12 with ADHD\n* Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)\n\nExclusion Criteria:\n\n1. Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD.\n2. Non English Speaking\n3. the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits\n4. Another child in the same family participating in this study already\n5. Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time.","locations":[{"facility":"Penn State Health Dept of Psychiatry","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"James G Waxmonsky, MD","phone":"7175318646","email":"jwaxmonsky@pennstatehealth.psu.edu"}],"primaryOutcomes":["Change in Oppositional Defiant Disorder Symptoms (change from baseline to endpoint)"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["hershey-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Behavioral Parenting Intervention for ADHD","inPlainEnglish":"Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions. H1: Reduced parental ER capacity will predict diminished how well it works for behavioral parent training to improve negative parenting behavior (NPB) and behavior problems in offspring with ADHD.","whoItsFor":["Ages 5 Years to 12 Years","Parent of a child ages 5-12 with ADHD","Parent must report that the child has at least a mild level of symptoms at home of Oppositional Defiant Disorder (ODD) on the Disruptive Behavior Disorder Rating Scale (DBDRS)"],"whoShouldSkip":["Not being the parent of a child ages 5-12 who meets diagnostic criteria for ADHD","Non English Speaking","the child with ADHD has a diagnosis of intellectual delay or has prominent autistic traits","Another child in the same family participating in this study already","Parent does not have a smartphone or tablet device to complete EMA ratings or does not reside with child for the majority of the time"],"whatHappens":"If you join, the listed intervention(s) are Behavioral Parenting Intervention. The registry lists allocation as na. Aim: To examine if parental emotion regulation (ER) moderates the response to parent training interventions.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 65 people at Hershey. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.656Z"},{"nctId":"NCT05303467","title":"A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM","officialTitle":"FRONTIER: A Feasibility Study to Evaluate the Safety of the TheRaSphere GliOblastoma (GBM) Device iN PaTIEnts With Recurrent GBM","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boston Scientific Corporation","sponsorClass":"INDUSTRY","summary":"The FRONTIER Study is a prospective, interventional, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.","conditions":["Glioblastoma Multiforme","Recurrent Glioblastoma"],"keywords":[],"interventions":[{"type":"DEVICE","name":"TheraSphere GBM"}],"enrollment":36,"startDate":"2022-07-30","completionDate":"2027-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject is 18 years or older and has signed and dated the trial informed consent form (ICF)\n2. Life expectancy ≥ 12 weeks\n3. Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule\n4. History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria\n5. Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria\n6. Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)\n7. Prior cranial radiation dose \\< 66 Gy\n8. WHO performance status ≤ 2\n9. The interval since completion of cranial radiotherapy must be \\> 6 months, unless there is tissue confirmation of tumor recurrence/progression outside the previous radiation treatment field, in which case the interval since completion of cranial radiation must be at least 12 weeks\n10. Interval since last systemic therapy until presumed date of intervention ≥ 1 cycle or ≥ 2 biological half-lives, i.e.\n\n    1. ≥ 4 weeks since last dose of temozolomide\n    2. ≥ 6 weeks since last dose of lomustine or other nitrosourea\n    3. ≥ 2 weeks since last dose of a small molecule targeted agent (Tyrosine Kinase Inhibitor or similar)\n    4. ≥ 6 weeks from last dose of last intravenous bevacizumab infusion, or other antibody-based VEGF therapy\n11. If receiving steroids, patient should be on a stable or decreasing dose equivalent to dexamethasone ≤ 6 mg/d, for at least 7 days prior to registration\n12. Have adequate organ and bone marrow function within 14 days prior to registration, as defined below:\n\n    1. INR ≤ 1.2 (in absence of anticoagulation)\n    2. Platelets ≥ 100,000/L\n    3. Creatinine ≤1.5 mg/dL\n    4. Absolute Neutrophil Count ≥1.5 x 10\\^9/L\n    5. Hemoglobin ≥9.0 g/dL\n13. Have a negative pregnancy test within 14 days prior to registration on study (for FOCBP, female of child-bearing potential)\n14. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active must be using, or agree to use, a medically acceptable method of birth control as confirmed by the investigator\n15. Angiographic Mapping Inclusion Criteria:\n\n    1. Accessible neurovascular anatomy that allows for safe microcatheter placement (up to two locations) to infuse TheraSphere GBM to treat all of the T1 enhancing component of target lesion confirmed by neuro-interventional team.\n    2. Total treatment volume is ≤ 150cc as determined by multidisciplinary team.\n16. Additional Inclusion Criteria:\n\n    1. Group A: perfused volume encompasses the non-dominant hemisphere and non-eloquent regions of the brain\n    2. Group B: perfused volume encompasses the non-dominant hemisphere and eloquent regions of the brain\n    3. Group C: perfused volume encompasses the dominant hemisphere and non-eloquent regions of the brain\n    4. Group D: perfused volume encompasses the dominant hemisphere and eloquent regions of the brain\n\nExclusion Criteria:\n\n1. Have bilateral gadolinium enhancing disease, tumor located in the posterior fossa, tumor involving critical subcortical structures (thalamus/hypothalamus, midbrain, brainstem, corticospinal tract, internal capsule, cerebral peduncle), tumor approximating or invading the brainstem and/or optic chiasma, leptomeningeal disease, or extracranial metastatic disease\n2. Have received more than 1 course of prior cranial radiotherapy (EBRT)\n3. Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy\n4. Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide\n5. Have received prior intra-arterial cerebral infusion therapy\n6. Have received more than 2 surgical GBM-related procedures\n7. Have received prior thoracic radiation therapy\n8. Are at increased risk of wound dehiscence by the discretion of the investigators (e.g. brain surgery within the last 3 months, poor skin condition, and/or previously infected surgical field or any other condition that is of increased infectious risk in the opinion of the neurosurgeon)\n9. Have uncontrolled epilepsy\n10. Have severe and/or insufficiently controlled intercurrent illness; patients with the following are not eligible:\n\n    1. Hypertension grade 3 or higher without adequate control on medications\n    2. Symptomatic or unstable cardiac disease, known to have right-to-left shunts, or severe pulmonary hypertension (pulmonary artery pressure \\> 90 mmHg)\n    3. Pulmonary insufficiency (arterial oxygen pressure (Pa,O2) of \\< 60 mmHg, or oxygen saturation (Sa,O2) of \\< 90%) as measured by fingertip pulse oximeter\n    4. Ongoing or active bacterial or viral infection requiring systemic treatment (including HIV)\n    5. Pneumonitis\n    6. Psychiatric illness/social situations that would limit compliance with study requirements\n    7. Peripheral Neuropathy ≥ grade 1\n    8. Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety, study endpoints or longevity\n11. Are currently pregnant or breast feeding (unless patient agrees to stop breastfeeding)\n12. Patients with a history of an active other malignancy within 1 year prior to registration. NOTE: Exceptions to this requirement include adequately treated non-melanoma skin cancer or lentigo maligna or carcinoma in situ without evidence of disease, or recurrent glioblastoma\n13. Patients with a history of ischemic cerebral disease and/or at risk of cerebral herniation\n14. Medical contraindication to undergo contrast-enhanced magnetic resonance imaging (MRI)\n15. Known history of hypersensitivity reactions to iodinated and/or gadolinium-based contrast\n16. Subject has received any other investigational agents within 4 weeks of treatment, or is currently participating, or plans to participate in, another investigational trial that may confound the results of this trial (unless written approval is received from the Boston Scientific study team)\n17. Angiographic Mapping Exclusion Criteria: Patients with significant vascular disease, significant AV shunting, or anatomic tortuosity on MR/CT Angiogram precluding safe or feasible vascular access","locations":[{"facility":"University of Alabama Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Univerity","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Interventional Radiology Center","city":"Baltimore","state":"Maryland","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lenox Hill Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sally Linda","phone":"952-201-3102","email":"Sally.Linda@bsci.com"},{"name":"Lilian Liu Pan","phone":"858-888-5682","email":"Lilian.LiuPan@bsci.com"}],"primaryOutcomes":["The number of grade 3-5 non-hematological toxicities","The number of ≥ grade 3 CNS toxicities related to non-target embolization","Occurrence of symptomatic brain radiation necrosis requiring medical or surgical intervention and confirmed by pathology","The number of Grade 4 neutropenia events persisting for longer than 5 days","The number of grade 4 febrile neutropenia","The number of grade 4 thrombocytopenia or grade 3 thrombocytopenia with hemorrhage"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","san-diego-california","san-francisco-california","jacksonville-florida","chicago-illinois","baltimore-maryland","st-louis-missouri","new-york-new-york","houston-texas"],"enrichment":{"headline":"Phase 1: TheraSphere GBM for Glioblastoma Multiforme","inPlainEnglish":"The FRONTIER Study is a prospective, treatment, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.","whoItsFor":["Ages 18 Years to any","Life expectancy ≥ 12 weeks","Subject is willing and able to comply with the trial testing, procedures, and follow-up schedule","History of a histologically confirmed diagnosis of glioblastoma per 2021 WHO criteria","Have radiographic evidence of tumor progression/recurrence with measurable disease (≥ 1 cm to ≤ 5cm bidirectional diameters) by contrast-enhancement on MRI, according to RANO criteria","Prior surgery and treatment with combination of radiotherapy and chemotherapy ± Tumor Treating Fields (Optune®)","Prior cranial radiation dose \\< 66 Gy","WHO performance status ≤ 2"],"whoShouldSkip":["Have received more than 1 course of prior cranial radiotherapy (EBRT)","Have received radiosurgery, brachytherapy, or hypofractionated radiotherapy","Have received more than 2 systemic treatment protocols (lines of treatment), not including maintenance temozolomide","Have received prior intra-arterial cerebral infusion therapy","Have received more than 2 surgical GBM-related procedures","Have received prior thoracic radiation therapy","Have uncontrolled epilepsy"],"whatHappens":"If you join, the listed intervention(s) are TheraSphere GBM. The registry lists allocation as randomized. The FRONTIER Study is a prospective, treatment, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 9 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.483Z"},{"nctId":"NCT05312255","title":"Non-chemotherapeutic Interventions for the Improvement of Quality of Life and Immune Function in Patients With Multiple Myeloma","officialTitle":"Improving Host Factors in Patients With Monoclonal Gammopathies and Other Hematologic Disorders","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Roswell Park Cancer Institute","sponsorClass":"OTHER","summary":"This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life. Another purpose of this study is for researchers to learn how the addition of a beta-blocker (propranolol) to the standard treatment regimen in patients with newly diagnosed multiple myeloma affects immune response and quality of life. A study from the Mayo Clinic looked at multiple myeloma patients who were on a beta-blocker while undergoing chemotherapy and found that the use of a beta-blocker resulted in improved patient survival outcomes. Non-chemotherapeutic treatment options may help decrease symptoms and improve quality of life for patients with multiple myeloma.","conditions":["Plasma Cell Myeloma","Recurrent Plasma Cell Myeloma","Refractory Plasma Cell Myeloma","Smoldering Plasma Cell Myeloma"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral Intervention"},{"type":"DRUG","name":"Beta-Adrenergic Antagonist"},{"type":"DRUG","name":"Propranolol"},{"type":"OTHER","name":"Quality-of-Life Assessment"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"OTHER","name":"Resistance Training"},{"type":"OTHER","name":"Short-Term Fasting"}],"enrollment":265,"startDate":"2022-06-28","completionDate":"2027-06-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>= 18 years of age\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:\n\n  * Module A: ECOG 0 - 1\n  * Module B: ECOG 0 - 2\n  * Module C: ECOG 0 - 2\n  * Module D: ECOG 0-1\n  * Module E: ECOG 0-1\n* MODULE A -C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or\n* MODULE D: non transfusion dependent low-risk MDS\n* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion\n* Are able to understand and follow assessment and intervention procedures\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n* MODULE A, D and E: (PHYSICAL ACTIVITY): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access\n* MODULE B (NUTRITION): Not applicable\n* MODULE C (BETA BLOCKER): Newly diagnosed patients with multiple myeloma necessitating treatment and before initiation of systemic therapy\n* MODULE C: Female participants of child-bearing potential must have a negative pregnancy test at study entry and then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Male patients with female partners of child-bearing potential should also use adequate contraceptive methods (see above). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately MODULE D (PHYSICAL ACTIVITY): Patients with MDS not necessitating transfusion therapy at time of enrollment (no transfusion within 8 weeks prior to enrollment) i.e. patients on observation, or receiving growth factors or luspatercept only\n\n  * MODULE E (EX-MT): Have a planned autologous stem cell transplant (ASCT) for front line therapy\n  * MODULE E (EX-MT): Be enrolled in the Biorepository and Laboratory Services (BLS) Universal Consent with completed epidemiological questionnaire\n  * MODULE E (EX-MT): Report being inactive or low active during the peri-diagnosis and treatment period leading up to study enrollment\n  * MODULE E (EX-MT): Participant has access to a personal computer or tablet with camera, microphone, speakers and internet access\n  * MODULE E (EX-MT): Receive appropriate medical clearances to exercise\n\nExclusion Criteria:\n\n* Major comorbidities that would cause danger to the patient when participating in the study and that would have a risk of progression if the patient took part in the study (including, but not limited to): cardiac or pulmonary and infectious diseases (e.g., ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia) or, psychiatric illness/social situations that would limit compliance with study requirements\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)\n* MODULE A and E:(PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system that is deemed to making the patient unsafe to participate. This will be assessed by radiologist, a neurosurgeon and/or an orthopedic surgeon, if applicable.\n* MODULE A and E: (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system\n* MODULE A and E: (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon\n* MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index \\[BMI\\] \\< 18)\n* MODULE B (NUTRITION): Special diets (physician prescribed)\n* MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin\n* MODULE B (NUTRITION): Other reasons not to withhold food\n* MODULE B (NUTRITION): Any condition which in the investigator's opinion deems the participant an unsuitable candidate to limit food consumption\n* MODULE C (BETA BLOCKER): Current use of a beta blocker (includes all non-selective and beta-1 selective blockers) or, use of a beta-blocker within 3 months of study enrollment\n* MODULE C (BETA BLOCKER): Contraindications to the use of beta-blockers, e.g.; severe sinus bradycardia; sick sinus syndrome; or heart block greater than first-degree, uncontrolled depression, unstable angina pectoris, uncontrolled heart failure (New York Heart Association \\[NYHA\\] Grade III or IV), hypotension ( systolic blood pressure \\< 100 mmHg), severe asthma or chronic obstructive pulmonary disease (COPD), uncontrolled type I or type II diabetes mellitus (HbA1C \\> 8.5 or 12h fasting plasma glucose \\> 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channel blocker use (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded\n* MODULE C (BETA BLOCKER): Pregnant or nursing female participants, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test\n* MODULE D: Cardiovascular disease which is deemed limiting exercise readiness by a cardiologist","locations":[{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Changes in immune cell subsets"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["buffalo-new-york"],"enrichment":{"headline":"Not a traditional drug phase: testing Beta-Adrenergic Antagonist for Plasma Cell Myeloma","inPlainEnglish":"This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life.","whoItsFor":["Ages 18 Years to any","Age \\>= 18 years of age","Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of:","Module A: ECOG 0 - 1","Module B: ECOG 0 - 2","Module C: ECOG 0 - 2","MODULE A -C: Have a diagnosis of smoldering multiple myeloma, multiple myeloma or plasma cell leukemia (PCL) or","MODULE D: non transfusion dependent low-risk MDS"],"whoShouldSkip":["Unwilling or unable to follow protocol requirements","Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects)","MODULE A and E: (PHYSICAL ACTIVITY): Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system","MODULE A and E: (PHYSICAL ACTIVITY): Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced surgeon","MODULE B (NUTRITION): Clinical signs of malnutrition (body mass index \\[body-mass index (BMI)\\] \\< 18)","MODULE B (NUTRITION): Special diets (physician prescribed)","MODULE B (NUTRITION): Diabetic treated with glucose-lowering medications and/or insulin"],"whatHappens":"If you join, the listed intervention(s) are Behavioral Intervention, Beta-Adrenergic Antagonist, or Propranolol. The registry lists allocation as randomized. This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 265 people at Buffalo. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.485Z"},{"nctId":"NCT05327023","title":"Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies","officialTitle":"Phase I/II Study Using Prophylactic Donor Lymphocyte Infusion Early Post-Transplant After Allogeneic Hematopoietic Cell Transplantation Using Post-Transplantation Cyclophosphamide for High-Risk Hematologic Malignancies","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nPeople with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high. Researchers want to see if giving the transplant recipient an infusion of lymphocytes (a type of white blood cell) from their transplant donor early after the transplant can reduce that risk.\n\nObjective:\n\nTo learn if giving donor lymphocytes early after a transplant will help reduce the risk of relapse for people with certain blood cancers.\n\nEligibility:\n\nAdults aged 18-65 with high-risk leukemia, lymphoma, myelodysplastic syndrome, or multiple myeloma that does not respond well to standard treatments and/or has a high risk of relapse. Healthy potential bone marrow and lymphocyte donor relatives aged 12 and older are also needed.\n\nDesign:\n\nParticipants will be screened with:\n\nPhysical exam\n\nBlood and urine tests\n\nSpinal tap\n\nEye exam\n\nDental exam\n\nHeart and lung tests\n\nImaging scans. A radioactive substance may be injected in their arm if a PET scan is needed.\n\nBone marrow aspiration and biopsy\n\nSome screening tests will be repeated during the study.\n\nParticipants will stay at the NIH hospital for about 4 weeks. They will receive a central venous catheter. They will get chemotherapy and other drugs starting 6 days before transplant. Then they will have their transplant. They will receive donor white blood cells 7 days later. They will give blood, bone marrow, urine, and stool samples for research. They must stay near NIH for at least 100 days after transplant.\n\nParticipants will have periodic follow-up visits for 5 years.\n\nHealthy donors will have 2-3 visits. They will give blood, bone marrow, white blood cells, and stool samples for research.\n\nParticipation will last for 5 years....","conditions":["Hematologic Neoplasms"],"keywords":["Prophylactic Donor Lymphocyte Infusions","Chronic Graft-Versus-Host Disease","Immunotherapeutic Strategies","myeloablative conditioning","Steroid-Refractory Grade"],"interventions":[{"type":"PROCEDURE","name":"donor lymphocyte infusion"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Busulfan"},{"type":"DRUG","name":"Mycophenolate mofetil"},{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Sirolimus"}],"enrollment":430,"startDate":"2022-05-23","completionDate":"2028-07-03","sex":"ALL","minAge":"12 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion Criteria - Recipient:\n\n* Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:\n\n  * Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse\n  * AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission \\[CR\\] with minimal residual disease detectable by any modality also will be eligible)\n  * AML with adverse cytogenetics (complex karyotype with \\>= 4 abnormalities) regardless of remission status\n  * Low risk myelodysplastic syndrome (MDS) (\\<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or \\>= 4 abnormalities) with induction failure or active relapse\n  * High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or \\< 4 abnormalities) with induction failure or active relapse\n  * High risk MDS (RAEB-1 or RAEB-2) with adverse cytogenetics (abnormal chromosome 7 or \\< 4 abnormalities) regardless of remission status\n  * Acute lymphoblastic leukemia (ALL) in CR \\>= 2 or with induction failure or active relapse (ALL in CR1 with minimal residual disease detected also will be eligible)\n  * Chronic myelocytic leukemia (CML) in blast crisis phase\n  * Hodgkin lymphoma with stable or progressive disease\n  * Mantle cell lymphoma with stable or progressive disease\n  * Relapsed Burkitt lymphoma in CR or partial remission (PR)\n  * Aggressive B-cell Non-Hodgkin Lymphoma (NHL) (e.g., diffuse large B-cell lymphoma, transformed indolent B-cell lymphoma) with stable or progressive disease\n  * T-cell NHL with stable or progressive disease\n  * Multiple myeloma (MM) with induction failure as defined by failure to achieve minimal response (CR, Very Good Partial Response \\[VGPR\\], or PR) or the development of progressive disease on primary therapy, or MM with active relapse as defined by previously treated myeloma that achieved a molecular response or better that then progressed\n* Age 18-65 years.\n* At least one potentially suitable HLA-haploidentical or HLA-matched donor\n* Karnofsky performance score \\>60%, see Appendix A\n* Recipient participants must have adequate organ function as defined below:\n\n  * Cardiac ejection fraction \\>=45% by 2D ECHO;\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \\>=50% predicted;\n  * Estimated serum creatinine clearance of \\>=60 ml/minute/1.73m\\^2 calculated using eGFR in the clinical lab;\n  * Total bilirubin \\<=2X the upper limit of normal;\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<=3X the upper limit of normal.\n* Myeloablative conditioning is toxic to the developing human fetus and is teratogenic. For this reason, the following measures apply:\n\n  --Women of child-bearing potential (WOCBP) and men must agree to use effective contraception (hormonal, surgical, IUD or barrier method of birth control; abstinence) from the start of conditioning regimen through at least one-year posttransplant. For the HLA haploidentical cohort the requirements are the same, however while taking sirolimus and for 12 weeks after the last dose, the birth control must be highly effective (hormonal, surgical, IUD, abstinence).\n* WOCBP must have a negative serum or urine pregnancy test within 7 days prior to enrollment.\n\nInclusion Criteria - Donor:\n\n-Related donor (age \\>=12) deemed suitable, eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood, bone marrow, and stool for research. Related donors will be evaluated in accordance with existing Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria - Recipient:\n\n* Subjects who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 3 weeks prior to the date of beginning conditioning.\n* Prior myeloablative conditioning for autologous or allogeneic HCT.\n* Active breastfeeding.\n* Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is metastatic, relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment. This excludes non-melanoma skin cancers.\n* Uncontrolled intercurrent illness (e.g. severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active hepatitis, uncontrolled dental infection) that in the opinion of the PI would make it unsafe to proceed with transplantation.\n\nExclusion Criteria - Donor:\n\nNone.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy H Chai","phone":"(240) 858-3755","email":"amy.chai@nih.gov"},{"name":"Christopher G Kanakry, M.D.","phone":"(240) 760-6171","email":"christopher.kanakry@nih.gov"}],"primaryOutcomes":["determine the maximally tolerated dose of DLI that can be safely administered after HLA-matched-related HCT and after HLA-haploidentical HCT"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","multiple-myeloma","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Cyclophosphamide for Hematologic Neoplasms","inPlainEnglish":"Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high.","whoItsFor":["Ages 12 Years to 120 Years","who can join - Recipient:","Histologically or cytologically confirmed hematologic malignancy classified as high or very high disease risk by the Refined Disease Risk Index for HCT including one of the following:","Acute myeloid leukemia (AML) with favorable cytogenetics (t(8;21), inv(16), t(15,17)) with induction failure (persistent disease without first achieving remission of any type) or active relapse","AML with intermediate cytogenetics (not classified as favorable or adverse) with induction failure or active relapse (AML with intermediate cytogenetics in morphologic complete remission \\[CR\\] with minimal residual disease detectable by any modality also will be eligible)","AML with adverse cytogenetics (complex karyotype with \\>= 4 abnormalities) regardless of remission status","Low risk myelodysplastic syndrome (MDS) (\\<= 5% blasts, including chronic myelomonocytic leukemia) with adverse cytogenetics (abnormal chromosome 7 or \\>= 4 abnormalities) with induction failure or active relapse","High risk MDS (RAEB-1 or RAEB-2) with intermediate-risk cytogenetics (no abnormal chromosome 7 or \\< 4 abnormalities) with induction failure or active relapse"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are donor lymphocyte infusion, Cyclophosphamide, or Busulfan. The registry lists allocation as na. Background: People with blood cancers often receive blood or bone marrow transplants.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 430 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.651Z"},{"nctId":"NCT05327699","title":"Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine","officialTitle":"Glutamatergic Adaptation to Stress as a Mechanism for Anhedonia and Treatment Response With Ketamine","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Emory University","sponsorClass":"OTHER","summary":"The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (MDD).","conditions":["Major Depressive Disorder"],"keywords":["Neuroscience","Stress response"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"OTHER","name":"Placebo"}],"enrollment":140,"startDate":"2022-11-08","completionDate":"2028-03-02","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nMDD Patients:\n\n* willing and able to give written informed consent\n* men or women, 18-65 years of age\n* primary diagnosis of DSM-V MDD, current, as diagnosed by the SCID-I\n* score of ≥20 on the Beck Depression Inventory, which will include patients characterized as having \"moderate/severe\" (20-28) or \"very-severe\" (29-63) depressive symptoms\n* off all antidepressant therapy for at least 8 weeks prior to the baseline visit\n\nHealthy Controls:\n\n* willing and able to give written informed consent\n* men or women, 18-65 years of age\n\nExclusion Criteria:\n\nMDD Patients:\n\n* history of any bipolar disorder or psychotic disorder\n* active psychotic symptoms of any type\n* substance abuse/dependence within 6 months of study entry (as determined by SCID)\n* unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination and laboratory testing), including upper respiratory disease or asthma, glaucoma or porphyria.\n* active suicidal ideation as determined by a score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSR)\n* use of any recreational drugs as confirmed by urine drug screen at the time of scanning\n* pregnancy or lactation\n* use of glucocorticoids at any time during the study\n* Raynaud's disease that may interfere with the cold-pressor\n* contraindications for MRI\n* MMSE score \\<28\n* elevated blood pressure prior to infusion (systolic \\> 160 or diastolic \\>100)\n* history of treatment resistance as determined by ATRQ\n* prior adverse reaction to ketamine\n* use of antipsychotic medications\n* use of greater than 2mg daily of lorazepam or similar benzodiazipine.\n* Regular smoker as self-reported\n\nHealthy Controls:\n\n* evidence of any psychiatric disorder with exception of specific phobia, and no history of any psychiatric disorder except mild past substance use disorder as diagnosed by the SCID-I\n* history of any substance abuse within the last 6 months\n* use of any recreational drugs as confirmed by urine drug screen at the time of scanning\n* pregnancy or lactation\n* use of glucocorticoids at any time during the study\n* Raynaud's disease that may interfere with the cold-pressor\n* contraindications for MRI\n* MMSE score \\<28\n* Regular smoker as self-reported","locations":[{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael Treadway, PhD","phone":"(404) 727-7541","email":"ketaminestudy@emory.edu"}],"primaryOutcomes":["Change in glutamate concentration in the medial prefrontal cortex (mPFC)"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["atlanta-georgia"],"enrichment":{"headline":"Early phase 1: testing Ketamine for Major Depressive Disorder","inPlainEnglish":"The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (major depression).","whoItsFor":["Ages 18 Years to 65 Years","men or women, 18-65 years of age","primary diagnosis of DSM-V major depression, current, as diagnosed by the SCID-I","score of ≥20 on the Beck Depression Inventory, which will include patients characterized as having \"moderate/severe\" (20-28) or \"very-severe\" (29-63) depressive symptoms","off all antidepressant therapy for at least 8 weeks prior to the baseline visit"],"whoShouldSkip":["history of any bipolar disorder or psychotic disorder","active psychotic symptoms of any type","substance abuse/dependence within 6 months of study entry (as determined by SCID)","unstable cardiovascular, endocrinologic, hematologic, hepatic, renal, or neurologic disease (as determined by physical examination and laboratory testing), including upper respiratory disease or asthma, glaucoma or porphyria","active suicidal ideation as determined by a score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSR)","use of any recreational drugs as confirmed by urine drug screen at the time of scanning","pregnancy or lactation"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to investigate the effects of ketamine on decision-making and emotion processing in a sample of individuals diagnosed with Major Depressive Disorder (major depression).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 140 people at Atlanta. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.794Z"},{"nctId":"NCT05334069","title":"Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection","officialTitle":"Blinded Reference Set for Multicancer Early Detection Blood Tests","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Alliance for Clinical Trials in Oncology","sponsorClass":"OTHER","summary":"This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.","conditions":["Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Ann Arbor Stage I Lymphoma","Ann Arbor Stage II Lymphoma","Ann Arbor Stage III Lymphoma","Ann Arbor Stage IV Lymphoma","Chronic Lymphocytic Leukemia","Chronic Myeloid Leukemia","Gastroesophageal Junction Adenocarcinoma","Head and Neck Carcinoma","Hematopoietic and Lymphoid Cell Neoplasm","Invasive Breast Carcinoma","Kidney Carcinoma","Malignant Hepatobiliary Neoplasm","Malignant Solid Neoplasm","Melanoma","Muscle-Invasive Bladder Carcinoma","Stage I Bladder Cancer AJCC v6 and v7","Stage I Breast Cancer AJCC v7","Stage I Colorectal Cancer AJCC v6 and v7","Stage I Esophageal Cancer AJCC V7","Stage I Gastric Cancer AJCC V7","Stage I Lung Cancer AJCC v7","Stage I Ovarian Cancer AJCC v6 and v7","Stage I Pancreatic Cancer AJCC v6 and v7","Stage I Prostate Cancer AJCC v7","Stage I Uterine Corpus Cancer AJCC v7","Stage II Bladder Cancer AJCC v6 and v7","Stage II Breast Cancer AJCC v6 and v7","Stage II Colorectal Cancer AJCC v7","Stage II Esophageal Cancer AJCC v7","Stage II Gastric Cancer AJCC v7","Stage II Lung Cancer AJCC v7","Stage II Ovarian Cancer AJCC v6 and v7","Stage II Pancreatic Cancer AJCC v6 and v7","Stage II Prostate Cancer AJCC v7","Stage II Uterine Corpus Cancer AJCC v7","Stage III Bladder Cancer AJCC v6 and v7","Stage III Breast Cancer AJCC v7","Stage III Colorectal Cancer AJCC v7","Stage III Esophageal Cancer AJCC v7","Stage III Gastric Cancer AJCC v7","Stage III Lung Cancer AJCC v7","Stage III Ovarian Cancer AJCC v6 and v7","Stage III Pancreatic Cancer AJCC v6 and v7","Stage III Prostate Cancer AJCC v7","Stage III Uterine Corpus Cancer AJCC v7","Stage IV Bladder Cancer AJCC v7","Stage IV Breast Cancer AJCC v6 and v7","Stage IV Colorectal Cancer AJCC v7","Stage IV Esophageal Cancer AJCC v7","Stage IV Gastric Cancer AJCC v7","Stage IV Lung Cancer AJCC v7","Stage IV Ovarian Cancer AJCC v6 and v7","Stage IV Pancreatic Cancer AJCC v6 and v7","Stage IV Prostate Cancer AJCC v7","Stage IV Uterine Corpus Cancer AJCC v7","RISS Stage I Multiple Myeloma","RISS Stage II Multiple Myeloma","RISS Stage III Multiple Myeloma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Questionnaire Administration"},{"type":"PROCEDURE","name":"Biospecimen Collection"}],"enrollment":2900,"startDate":"2022-08-18","completionDate":"2027-01-31","sex":"ALL","minAge":"40 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with a cancer diagnosis: Documentation of disease:\n\n  * Histologic documentation: Histologically confirmed diagnosis of invasive cancer\n  * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma\n\n    \\*\\* For leukemia: Type (chronic lymphocytic leukemia \\[CLL\\], chronic myeloid leukemia \\[CML\\], acute lymphoblastic lymphoma \\[ALL\\], acute myeloid leukemia \\[AML\\])\n    * For lymphoma (any type): Stage I-IV based on Ann Arbor staging\n    * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS)\n  * One of the following tumor types (synchronous cancers are not allowed and all neuroendocrine tumors are excluded):\n\n    * Colorectal\n    * Bladder\n    * Head and neck\n    * Hepatobiliary\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Lung\n    * Lymphoma\n    * Leukemia\n    * Ovary \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Pancreas\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Multiple myeloma\n    * Gastric, esophageal or gastroesophageal\n    * Breast\n    * Thyroid\n    * Kidney\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Endometrium\n\n      \\*\\*\\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment\n    * Prostate\n* Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision)\n* Participants with a cancer diagnosis: Age \\>= 40 and =\\< 75\n* Participants with a cancer diagnosis: No known current pregnancy by self-report\n* Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy other than the current cancer diagnosis. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.\n* Participants with a cancer diagnosis: Willingness to provide blood samples for research use\n* Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a cancer diagnosis: No history of organ transplantation\n* Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants without a cancer diagnosis and without suspicion of cancer: Age \\>= 40 and =\\< 75\n* Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report\n* Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers)\n* Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use\n* Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation\n* Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish\n\n  \\* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages\n* Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, hepatobiliary cancer, endometrial cancer or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw\n\n  \\* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma\n* Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs\n* Participants with a high suspicion of cancer: Age \\>= 40 and =\\< 75\n* Participants with a high suspicion of cancer: No known current pregnancy by self-report\n* Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy. Non-melanoma skin cancers (such as basal or squamous cell) are allowed.\n* Participants with a high suspicion of cancer: Willingness to provide blood samples for research use\n* Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL\n* Participants with a high suspicion of cancer: No history or organ transplantation\n* Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \\* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy 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Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.816Z"},{"nctId":"NCT05344469","title":"A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis","officialTitle":"A Non-interventional Study Evaluating Injectable Treatments (Ofatumumab, Glatiramer Acetate and Interferon β1) and Oral Treatments (Teriflunomide, Dimethyl Fumarate and Diroximel Fumarate) in Patients With Relapsing Multiple Sclerosis [AIOLOS]","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This is an observational, non-interventional, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany.\n\nProspective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years. Additionally, medical history of participants will be collected including disease duration, laboratory values, EDSS, MRI parameters and relapses.","conditions":["Relapsing Multiple Sclerosis"],"keywords":["Relapsing Multiple Sclerosis","RMS","NIS","ofatumumab"],"interventions":[{"type":"OTHER","name":"ofatumumab"},{"type":"OTHER","name":"glatiramer acetate"},{"type":"OTHER","name":"interferon β1"},{"type":"OTHER","name":"teriflunomide"},{"type":"OTHER","name":"dimethyl fumarate (DMF)"},{"type":"OTHER","name":"diroximel fumarate (DRF)"}],"enrollment":800,"startDate":"2022-05-10","completionDate":"2029-05-30","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Cohort 1 Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study\n2. Male or female patients aged ≥18 years at enrollment\n3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)\n4. RMS with active disease as defined by Lublin et al. (2014)\n5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment\n6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)\n7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment\n\nCohort 2 Inclusion Criteria:\n\n1. Signed informed consent must be obtained prior to participation,\n2. Male or female patients aged ≥18 years at enrollment,\n3. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),\n4. RMS with active disease as defined by Lublin et al. (2014) ,\n5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,\n6. Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),\n7. Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:\n\n   * Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab\n   * IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients\n\nCohort 1 Exclusion Criteria:\n\n1. Patients being treated outside of the approved label\n2. \\> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment\n3. Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)\n4. Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy\n5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator\n6. EDSS Functional System Score \"Pyramidal Functions\" ≥ 2 at enrollment\n7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab\n\nCohort 2 Exclusion Criteria:\n\n1. Patients being treated outside of the approved label,\n2. \\>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,\n3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,\n4. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2","locations":[{"facility":"Novartis Investigative Site","city":"Albstadt","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hettingen","state":"Baden-Wurttemberg","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Mannheim","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nagold","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Schwäbisch Hall","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Schwetzingen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bamberg","state":"Bavaria","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Dillingen an der Donau","state":"Bavaria","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Munich","state":"Bavaria","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Neuburg A.d. 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of patients who continue to receive their baseline treatment"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["albstadt-germany","hettingen-germany","mannheim-germany","nagold-germany","schw-bisch-hall-germany","schwetzingen-germany","bamberg-germany","dillingen-an-der-donau-germany","munich-germany","neuburg-a-d-donau-germany","regensburg-germany","unterhaching-germany","untermeitingen-germany","wolfratshausen-germany","falkensee-germany","bad-homburg-germany","frankfurt-am-main-germany","marburg-germany","hanover-germany","wildeshausen-germany","cologne-germany","dortmund-germany","d-sseldorf-germany","essen-germany","gelsenkirchen-germany","meerbusch-germany","m-nster-germany","oer-erkenschwick-germany","siegen-germany","ingelheim-germany","saarlouis-germany","chemnitz-germany","dresden-germany","g-rlitz-germany","leipzig-germany","altmark-germany","halle-germany","altenburg-germany","jena-germany","m-hlhausen-germany","aalen-germany","altenholz-germany","alzey-germany","bayreuth-germany","bergneustadt-germany","berlin-germany","bochum-germany","bogen-germany","bonn-germany","b-blingen-germany","braunschweig-germany","bremen-germany","coburg-germany","crailsheim-germany","dessau-germany","dillingen-saar-germany","duisburg-germany","eisleben-lutherstadt-germany","eltville-germany","erbach-im-odenwald-germany","erfurt-germany","erlangen-germany","fulda-germany","giessen-germany","gladenbach-germany","hagen-germany","hamburg-germany","h-xter-germany","itzehoe-germany","kaiserslautern-germany","karlsruhe-germany","l-nen-germany","magdeburg-germany","merzig-germany","mettmann-germany","minden-germany","montabaur-germany","m-lheim-germany","m-nchen-germany","neuruppin-germany","nuremberg-germany","oldenburg-germany","osnabr-ck-germany","pforzheim-germany","potsdam-germany","remscheid-germany","rostock-germany","r-dersdorf-germany","r-lzheim-germany","salzatal-germany","schiltach-germany","schneverdingen-germany","sinsheim-germany","stadtroda-germany","stuttgart-germany","tirschenreuth-germany","trier-germany","t-bingen-germany","velbert-germany","weil-der-stadt-germany"],"enrichment":{"headline":"Not a traditional drug phase: ofatumumab for Relapsing Multiple Sclerosis","inPlainEnglish":"This is an watch-and-measure (no experimental treatment required), non-treatment, multicenter, open-label study in patients being treated with any approved injectable or selected oral DMT for RMS in Germany. Prospective, primary data will be collected via questionnaires and an electronic case report form (eCRF) over a period of up to four years.","whoItsFor":["Ages 18 Years to 100 Years","Male or female patients aged ≥18 years at enrollment","Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)","RMS with active disease as defined by Lublin et al. (2014)","Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment","Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)","Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment","Cohort 2 who can join:"],"whoShouldSkip":["Patients being treated outside of the approved label","\\> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment","Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see who can join #7)","Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy","Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator","EDSS Functional System Score \"Pyramidal Functions\" ≥ 2 at enrollment","Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-treatment study with Ofatumumab"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 800 people at 109 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.271Z"},{"nctId":"NCT05351242","title":"THERMotherapy Against Persistent Bacterial LUNG Infections","officialTitle":"Thermotherapy Against Persistent Bacterial LUNG Infections","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Chronic Obstructive Pulmonary Disease Trial Network, Denmark","sponsorClass":"OTHER","summary":"The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.","conditions":["Lung Diseases, Obstructive","Bronchiectasis","Asthma","Copd","Chronic Obstructive Pulmonary Disease","Chronic Lung Infections"],"keywords":[],"interventions":[{"type":"OTHER","name":"Thermotherapy/sauna bath"}],"enrollment":150,"startDate":"2026-10-14","completionDate":"2032-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Competent and capable\n* FEV1\\>1,0 L\n* Have had a positive culture from sputum or BAL min. 2 times in the last 24 months for bacteria of the species: Pseudomonas aeruginosa, Stenotrophomonas maltophilia, Staphylococcus aureus, Haemophilus influenzae, Achromobacter xylosoxidans, Klebsiella oxytoca or Klebsiella pneumoniae. In addition, min. 1 positive culture after treatment with antibiotics\n* Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months\n\nExclusion Criteria:\n\n* Allergy to lidocaine and/or midazolam\n* Contraindications to bronchoscopy\n* Previous severe laryngospasm (intubation requiring)\n* Pregnancy/breastfeeding\n* Severe linguistic problems or inability to give informed consent\n* Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others","locations":[{"facility":"Herlev and Gentofte University hospital","city":"Hellerup","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Josefin V Eklöf, MD","phone":"38673555","email":"josefin.viktoria.ekloef@regionh.dk"},{"name":"Jens-Ulrik S Jensen, Professor","phone":"38673057","email":"jens.ulrik.jensen@regionh.dk"}],"primaryOutcomes":["Number of days from baseline without antibiotic treatment against pulmonary infection"],"hasResults":false,"conditionSlugs":["asthma","copd"],"drugSlugs":[],"locationSlugs":["hellerup-denmark"],"enrichment":{"headline":"Not a traditional drug phase: Thermotherapy/sauna bath for Lung Diseases, Obstructive","inPlainEnglish":"The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.","whoItsFor":["Ages 18 Years to any","Competent and capable","Willing to go to a sauna (min. temperature of 85℃ for at least 7 minutes) four times weekly for six months or avoid going to a sauna for six months"],"whoShouldSkip":["Allergy to lidocaine and/or midazolam","Contraindications to bronchoscopy","Previous severe laryngospasm (intubation requiring)","Pregnancy/breastfeeding","Severe mental illness that is not controlled with medication. NB: Patients with controlled mental illness can be included and will be asked on an equal footing as others"],"whatHappens":"If you join, the listed intervention(s) are Thermotherapy/sauna bath. The registry lists allocation as randomized. The aim of this study is to determine whether an intervention with frequent thermotherapy will be able to reduce the amount of colonizing bacteria in the bronchoalveolar lavage sample and eradicate the colonizing bacteria.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at Hellerup. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.342Z"},{"nctId":"NCT05361980","title":"Pediatric Orthopaedic Implant Safety & Efficacy","officialTitle":"Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of British Columbia","sponsorClass":"OTHER","summary":"Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity.\n\nGiven the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy.\n\nProspective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).","conditions":["Fracture","Lengthening; Leg","Orthopedic Disorder","Deformity of Limb","Deformity; Bone","Implant Breakage","Implant Complication","Hip Dysplasia","Pediatric ALL","Hip Disease","Hip Dislocation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Pediatric orthopaedic implant"}],"enrollment":4000,"startDate":"2022-01-06","completionDate":"2028-12","sex":"ALL","minAge":"0 Years","maxAge":"25 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly\n* Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product\n* Informed consent/assent is required\n\nExclusion Criteria:\n\n* Patients with a demonstrated sensitivity to metals\n* Patients with an inability to follow a post-operative regimen","locations":[{"facility":"BC Children's Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bryn Zomar, PhD","phone":"604-875-2359","email":"bryn.zomar@cw.bc.ca"},{"name":"Harpreet Chhina, PhD","phone":"604-875-2000","email":"hchhina@cw.bc.ca"}],"primaryOutcomes":["Device related adverse events","Implant survival","Implant efficacy"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["vancouver-canada"],"enrichment":{"headline":"Not a traditional drug phase: Pediatric orthopaedic implant for Fracture","inPlainEnglish":"Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and how well it works.","whoItsFor":["Ages 0 Years to 25 Years","Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product"],"whoShouldSkip":["Patients with a demonstrated sensitivity to metals","Patients with an inability to follow a post-operative regimen"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 4,000 people at Vancouver. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.838Z"},{"nctId":"NCT05366881","title":"cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease","officialTitle":"cfDNA Assay Multicenter Prospective Observational Validation for Early Cancer Detection, Minimal Residual Disease, and Relapse","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Adela, Inc","sponsorClass":"INDUSTRY","summary":"This is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care.\n\nAdditionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.","conditions":["Brain Cancer","Breast Cancer","Bladder Cancer","Cervical Cancer","Colorectal Cancer","Endometrial Cancer","Esophageal Cancer","Stomach Cancer","Head and Neck Cancer","Hepatobiliary Cancer","Leukemia","Lung Cancer","Lymphoma","Multiple Myeloma","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Renal Cancer","Sarcoma","Thyroid Cancer"],"keywords":["Multi-cancer early detection","Liquid Biopsy","Methylome","Cancer screening","cell-free DNA"],"interventions":[],"enrollment":7000,"startDate":"2022-05-03","completionDate":"2026-12-31","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Case Inclusion Criteria:\n\n* Newly diagnosed (within 120 days) with cancer or a recurrence of a cancer diagnosed \\>5 years ago of one of the following subtypes: Invasive Brain, Breast, Bladder, Cervical, Colorectal, Endometrial, Esophageal, Gastric, Head and Neck, Hepatobiliary, Lung, Ovarian, Pancreatic, Prostate, Renal, Sarcoma, Thyroid; Leukemia, Lymphoma, Multiple Myeloma\n* Able and willing to provide informed consent\n* ≥40 years of age\n\nCase Exclusion Criteria:\n\n* Currently receiving any treatment for cancer\n* Currently taking any demethylating agents/DNA hypomethylating agents\n* Simultaneously diagnosed with two or more invasive cancers\n* Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years\n* Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer\n* Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer\n* Women who are known to be pregnant (self-reported)\n\nControl Inclusion Criteria\n\n* Not diagnosed with any cancer in the last 5 years (non-invasive cancer is allowed)\n* Able and willing to provide informed consent\n* ≥40 years of age\n\nControl Exclusion Criteria\n\n* Currently receiving any treatment for cancer\n* Currently taking any demethylating agents/DNA hypomethylating agents\n* Women who are known to be pregnant (self-reported)","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"North Georgia Health System","city":"Gainesville","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist Floyd","city":"New Albany","state":"Indiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist Corbin","city":"Corbin","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist Hardin","city":"Elizabethtown","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist Paducah","city":"Paducah","state":"Kentucky","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Allina Health Cancer Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Oregon Health Sciences University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McLeod Health","city":"Florence","state":"South Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Baptist (BHMCC)","city":"Memphis","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Vanderbilt-Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Elligo Health Research, Inc.","city":"Austin","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Brian Allen, MS","phone":"203-514-4155","email":"brian.allen@adelabio.com"},{"name":"Michelle Anderson","phone":"475-766-8183","email":"michelle.anderson@adelabio.com"}],"primaryOutcomes":["Detection of cancer"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","colorectal-cancer","pancreatic-cancer","ovarian-cancer","leukemia","lymphoma","multiple-myeloma","bladder-cancer","stomach-cancer","cervical-cancer","endometrial-cancer","head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","miami-florida","gainesville-georgia","new-albany-indiana","corbin-kentucky","elizabethtown-kentucky","lexington-kentucky","paducah-kentucky","minneapolis-minnesota","rochester-minnesota","cleveland-ohio","portland-oregon","charleston-south-carolina","florence-south-carolina","memphis-tennessee","nashville-tennessee","austin-texas"],"enrichment":{"headline":"cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease","inPlainEnglish":"This is an watch-and-measure (no experimental treatment required) case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid.","whoItsFor":["Ages 40 Years to any"],"whoShouldSkip":["Currently receiving any treatment for cancer","Currently taking any demethylating agents/DNA hypomethylating agents","Simultaneously diagnosed with two or more invasive cancers","Diagnosed with any invasive or non-invasive cancer in addition to the index cancer in the last 5 years","Currently diagnosed with any chronic hematopoietic cancer (e.g. chronic CLL) in addition to the index cancer","Currently diagnosed with any myelodysplastic syndromes and/or precursor hematologic conditions (e.g. MGUS) in addition to the index cancer","Women who are known to be pregnant (self-reported)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 7,000 people at 17 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.505Z"},{"nctId":"NCT05370430","title":"BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL","officialTitle":"A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"PeproMene Bio, Inc.","sponsorClass":"INDUSTRY","summary":"A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)","conditions":["Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma"],"keywords":["Relapsed or Refractory","Mantle Cell Lymphoma","BAFFR-CAR T cells","B-cell Non-Hodgkin's Lymphoma","B-NHL","BAFFR","MCL","LBCL"],"interventions":[{"type":"BIOLOGICAL","name":"BAFFR-CAR T cells"}],"enrollment":36,"startDate":"2022-06-13","completionDate":"2027-07-13","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Informed Consent: Signed informed consent by the participant or legally authorized representative.\n2. Age \\& Performance Status:\n\n   * Age ≥ 18 years\n   * ECOG performance status ≤ 2\n3. Diagnosis \\& Disease Criteria:\n\n   * Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.\n   * BAFF-R expression on lymphoma cells required.\n4. Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.\n5. Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \\< 5% before leukapheresis.\n6. Organ Function \\& Laboratory Criteria:\n\n   * Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement).\n   * Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT \\< 3x ULN.\n   * Renal Function: CrCl ≥ 50 mL/min.\n   * Cardiac \\& Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation \\> 91% on room air.\n7. Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).\n8. Reproductive Considerations:\n\n   * Negative pregnancy test for females of childbearing potential.\n   * Use of effective contraception or abstinence through 3 months post-treatment.\n\nExclusion Criteria:\n\n1. Prior Therapies \\& Transplants:\n\n   * Prior allogeneic SCT.\n   * Autologous SCT \\< 6 months before leukapheresis.\n   * Concurrent systemic steroids or chronic immunosuppressant use.\n2. Disease-Specific Exclusions:\n\n   * Cardiac lymphoma involvement.\n   * Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).\n3. Medical Conditions:\n\n   * Active autoimmune disease requiring immunosuppressants.\n   * Primary immunodeficiency.\n   * Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months).\n   * Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders.\n   * History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years.\n   * Uncontrolled systemic infections or active CNS lymphoma.\n4. Pregnancy \\& Breastfeeding: Females who are pregnant or nursing.\n5. Other Considerations:\n\n   * Investigator-determined safety concerns.\n   * Potential noncompliance with study procedures.","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Hospital","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Swedish Cancer Institute","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hazel (Ting-Ying) Cheng, PhD","phone":"714-599-8077","email":"hazel.cheng@pepromenebio.com"},{"name":"Lisa Thurman","phone":"949-301-3438","email":"lisa.thurman@pepromenebio.com"}],"primaryOutcomes":["Incidence of adverse events","Maximum Tolerated Dose (MTD)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["duarte-california","stanford-california","kansas-city-kansas","minneapolis-minnesota","seattle-washington"],"enrichment":{"headline":"Phase 1: testing BAFFR-CAR T cells for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma","inPlainEnglish":"A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)","whoItsFor":["Ages 18 Years to any","Age \\& Performance Status:","how well you can do daily activities (ECOG score) ≤ 2","Diagnosis \\& Disease Criteria:","Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions","BAFF-R expression on lymphoma cells required","Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen","Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \\< 5% before leukapheresis"],"whoShouldSkip":["Prior Therapies \\& Transplants:","Prior allogeneic SCT","Autologous SCT \\< 6 months before leukapheresis","Concurrent systemic steroids or chronic immunosuppressant use","Disease-Specific Exclusions:","Cardiac lymphoma involvement","Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction)"],"whatHappens":"If you join, the listed intervention(s) are BAFFR-CAR T cells. The registry lists allocation as na. A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.142Z"},{"nctId":"NCT05372172","title":"Tennessee Alzheimer's Project","officialTitle":"Tennessee Alzheimer's Project","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Vanderbilt University Medical Center","sponsorClass":"OTHER","summary":"The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities.","conditions":["Aging","Alzheimer Disease","Biomarker","Cognitive Dysfunction","Mild Cognitive Impairment","Dementia","Cognition"],"keywords":["Alzheimer's disease","biomarkers","brain MRI","mild cognitive impairment","vascular risk factors","longitudinal studies"],"interventions":[{"type":"OTHER","name":"none, observational study"}],"enrollment":1000,"startDate":"2021-10-27","completionDate":"2030-03-31","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 60 or older\n* Meet standard criteria for (a) cognitively unimpaired, (b) mild cognitive impairment, or (c) Alzheimer's disease\n* English speaking\n* Individuals who lack decisional capacity to provide informed consent at baseline will not be enrolled in the study\n\nExclusion Criteria:\n\n* No available reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person or by phone)\n* History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness.\n* Unable to undergo MRI (e.g., claustrophobia, ferrous metal in body)","locations":[{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle Houston","phone":"615-875-3175","email":"michelle.houston@vumc.org"}],"primaryOutcomes":["Cognitive status","APOE Genotype","White matter hyperintensities Volume","Grey Matter Volume","Cerebral Blood Flow","Lacunar infarcts","Microbleeds","Left ventricular ejection fraction","Cardiac output","Stroke volume","Heart rate","Biological markers for Alzheimer's disease","Blood based biological marker for Alzheimer's disease"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: none, observational study for Aging","inPlainEnglish":"The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease.","whoItsFor":["Ages 60 Years to any","Meet standard criteria for (a) cognitively unimpaired, (b) mild cognitive impairment, or (c) Alzheimer's disease"],"whoShouldSkip":["No available reliable study partner (reliable is defined as someone who interacts significantly with the participant and is available to participate in study visits in person or by phone)","History of major psychiatric illness (e.g., schizophrenia, bipolar), neurological illness (e.g., epilepsy, multiple sclerosis, Parkinson's disease), or head injury with significant loss of consciousness","Unable to undergo MRI (e.g., claustrophobia, ferrous metal in body)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Nashville. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.319Z"},{"nctId":"NCT05373043","title":"Long-term COVID and Rehabilitation","officialTitle":"Evaluating the Long-term Health Consequences of COVID-19 and Rehabilitation Therapies to Speed Convalescence","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"The proposed focuses on improving both morbidity and mortality in older Veterans and those recovering from COVID-19 by developing rehabilitation therapies to augment vascular endothelial function by combating the oxidative stress and inflammation associated with aging and further induced by COVID-19. The investigators expected outcomes will have an important positive impact because they will provide scientifically sound recommendations for rehabilitation to improve vascular endothelial function and minimize the long-term consequences of COVID-19.","conditions":["Long-COVID"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Mitoquinone"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":300,"startDate":"2022-11-01","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Long-COVID and COVID-recovered patients must have SARS-CoV-19 positive test near the time of COVID-19 diagnosis\n* Long-COVID and COVID-recovered patients must be 3-12 months post-initial COVID-19 diagnosis\n* Ability to sign informed consent\n\nExclusion Criteria:\n\n* BMI \\>45 kg/m2\n* Unstable (\\<6 months) or severe coronary artery disease (CAD-RADS score = 4A), peripheral artery disease (Ankle Brachial Index \\<0.40), cerebrovascular disease (identified by previous stroke in last 12 months), severe COPD (=Stage III), uncontrolled hypertension (\\>160/100 mmHg), chronic kidney disease requiring dialysis, severe renal insufficiency (creatinine clearance \\<30 by the Cockcroft-Gault formula), Alzheimer's disease, dementia\n* Orthopedic limitations that would prohibit exercise\n* Current smokers and individuals that stopped smoking in the last 10 years\n* Already taking Mito-Q or unwilling to cease dietary supplements for participation\n* Any other condition or event considered exclusionary by the PIs or a physician","locations":[{"facility":"VA Salt Lake City Health Care System, Salt Lake City, UT","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joel D Trinity, PhD","phone":"(801) 582-1565","email":"Joel.Trinity@va.gov"},{"name":"Russell S Richardson, PhD","phone":"(801) 582-1565","email":"r.richardson@hsc.utah.edu"}],"primaryOutcomes":["Change in Flow Mediated Dilation (FMD)","Change in Microvascular Function with passive leg movement (PLM)","Change in Cerebral Vascular Endothelial Function with Breath Hold Acceleration Index (BHAI)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["salt-lake-city-utah"],"enrichment":{"headline":"Not a traditional drug phase: Mitoquinone for Long-COVID","inPlainEnglish":"The proposed focuses on improving both morbidity and mortality in older Veterans and those recovering from COVID-19 by developing rehabilitation therapies to augment vascular endothelial function by combating the oxidative stress and inflammation associated with aging and further induced by COVID-19. The investigators expected outcomes will have an important positive impact because they will provide scientifically sound recommendations for rehabilitation to improve vascular endothelial function and minimize the long-term consequences of COVID-19.","whoItsFor":["Ages 18 Years to any","Long-COVID and COVID-recovered patients must have SARS-CoV-19 positive test near the time of COVID-19 diagnosis","Long-COVID and COVID-recovered patients must be 3-12 months post-initial COVID-19 diagnosis"],"whoShouldSkip":["Orthopedic limitations that would prohibit exercise","Current smokers and individuals that stopped smoking in the last 10 years","Already taking Mito-Q or unwilling to cease dietary supplements for participation","Any other condition or event considered exclusionary by the PIs or a physician"],"whatHappens":"If you join, the listed intervention(s) are Mitoquinone, or Placebo. The registry lists allocation as randomized. The proposed focuses on improving both morbidity and mortality in older Veterans and those recovering from COVID-19 by developing rehabilitation therapies to augment vascular endothelial function by combating the oxidative stress and inflammation associated with aging and further induced by COVID-19.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Salt Lake City. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.244Z"},{"nctId":"NCT05389787","title":"Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study","officialTitle":"Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"DOUBLE","sponsor":"Northwell Health","sponsorClass":"OTHER","summary":"This is a single-site, sham-controlled, randomized trial in a total of 40 subjects between ages 18 and 60 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:\n\nArm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS\n\nEach participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.","conditions":["Schizophrenia","Cerebellar Function","Condition"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Transcranial Magnetic Stimulation"}],"enrollment":40,"startDate":"2022-08-18","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female subjects 18 to 60 years of age\n2. DSM-V diagnosis of schizophrenia spectrum disorders\n3. Competent to provide informed consent\n\nExclusion Criteria:\n\n1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders\n2. Lifetime diagnosis of ataxia or other cerebellar disorders\n3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders\n4. Any active general medical condition or CNS disease which can affect cognition or response to treatment\n5. Substance dependence or abuse in the past six months\n6. Seizure history\n7. TMS within three months or ECT within six months\n8. Pregnancy as indicated by self-report\n9. MRI contraindications","locations":[{"facility":"Zucker Hillside Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Cerebellar function"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Transcranial Magnetic Stimulation for Schizophrenia","inPlainEnglish":"This is a single-site, sham-controlled, randomly assigned trial in a total of 40 subjects between ages 18 and 60 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients.","whoItsFor":["Ages 18 Years to 60 Years","Male or female subjects 18 to 60 years of age","DSM-V diagnosis of schizophrenia spectrum disorders"],"whoShouldSkip":["Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders","Lifetime diagnosis of ataxia or other cerebellar disorders","Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders","Any active general medical condition or CNS disease which can affect cognition or response to treatment","Substance dependence or abuse in the past six months","TMS within three months or ECT within six months","Pregnancy as indicated by self-report"],"whatHappens":"If you join, the listed intervention(s) are Transcranial Magnetic Stimulation. The registry lists allocation as randomized. This is a single-site, sham-controlled, randomly assigned trial in a total of 40 subjects between ages 18 and 60 years with schizophrenia.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at New York. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.045Z"},{"nctId":"NCT05394103","title":"Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors","officialTitle":"A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901Administered Via Intravenous Infusion as Monotherapy and in Combination With Pembrolizumab in Adult Patients With Selected Advanced Solid Tumors With Cohort Expansions at the Recommended Phase 2 Dose","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Qurient Co., Ltd.","sponsorClass":"INDUSTRY","summary":"Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab","conditions":["Advanced Cancer","Metastatic Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mocaciclib (Q901)"},{"type":"DRUG","name":"KEYTRUDA® (pembrolizumab)"},{"type":"DRUG","name":"Fulvestrant"}],"enrollment":130,"startDate":"2022-08-30","completionDate":"2029-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit\n* Measurable disease per RECIST v 1.1\n* ECOG performance status 0,1 or 2\n* Life expectancy of at least 3 months\n* Age ≥ 18 years\n* Signed, written IRB-approved informed consent form\n\nExclusion Criteria:\n\n* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months\n* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec (females) and \\>450 msec (males)\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy\n* Active, poorly controlled autoimmune or inflammatory diseases","locations":[{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Health System Hospital","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Crowley Cancer Research","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keimyung University","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center","city":"Goyang-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHA University Bundang Medical Center","city":"Seongnam-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ajou University","city":"Suwon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Qurient Clinical Trial Information","phone":"+82-31-8060-1610","email":"clinicaltrial_info@qurient.com"}],"primaryOutcomes":["Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["pembrolizumab"],"locationSlugs":["phoenix-arizona","los-angeles-california","jacksonville-florida","chicago-illinois","rochester-minnesota","morristown-new-jersey","dallas-texas","daegu-south-korea","goyang-si-south-korea","seongnam-si-south-korea","seoul-south-korea","suwon-south-korea"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Mocaciclib (Q901) for Advanced Cancer","inPlainEnglish":"Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a this drug alone and in combination with pembrolizumab","whoItsFor":["Ages 18 Years to any","Measurable disease per RECIST v 1.1","how well you can do daily activities (ECOG score) 0,1 or 2","Life expectancy of at least 3 months"],"whoShouldSkip":["New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months","Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \\>470 msec (females) and \\>450 msec (males)","Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy","Active, poorly controlled autoimmune or inflammatory diseases"],"whatHappens":"If you join, the listed intervention(s) are Mocaciclib (Q901), KEYTRUDA® (pembrolizumab), or Fulvestrant. The registry lists allocation as randomized. Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a this drug alone and in combination with pembrolizumab","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 130 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.643Z"},{"nctId":"NCT05398094","title":"Clinical Trial of AMG510 in Stage III Unresectable NSCLC KRAS p.G12C Patients and Ineligible for Chemo-radiotherapy","officialTitle":"Phase II Clinical Trial of AMG510 (Sotorasib) in Stage III Unresectable NSCLC KRAS p.G12C Patients and Medically Ineligible for Concurrent Chemo-radiotherapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Fundación GECP","sponsorClass":"OTHER","summary":"Open-label, non-randomised, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to evaluate the efficacy of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.","conditions":["Non-small Cell Lung Cancer Stage III","KRAS P.G12C"],"keywords":["Sotorasib","Unresectable","Chemo-radiotherapy","Lung cancer"],"interventions":[{"type":"DRUG","name":"Sotorasib"}],"enrollment":19,"startDate":"2022-03-21","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Male or female, aged ≤ 80 years old\n* 2\\. ECOG performance status of 0-1\n* 3\\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology.\n* 4\\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy.\n* 5\\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC.\n* 6\\. Having a life expectancy ≥ 12 weeks\n* 7\\. Patients must be ineligible for concurrent chemo-radiotherapy because of:\n\n  1. Tumor size ≥ 5 cm and lymph node N2 involvement\n  2. The target lesion has to be bulky disease and/or more than 35% of the total volume of the two lungs should receive more than 20 Gy (V20) or inadequate pulmonary function\n  3. Interstitial Lung diseases\n  4. Prior treatment with thoracic radiotherapy for any reason\n  5. Or under decision of a tumor committee as inappropriate due to local characteristics to perform treatment upfront\n* 8\\. PET-CT at baseline is mandatory to confirm the absence of distant disease and to confirm unresectable disease\n* 9\\. PET-CT positive mediastinic adenopathies must be histologically confirmed. Mediastinic involvement could be considered without histological test when no margin can be distinguished in the lymph node mass.\n* 10\\. Brain CT or MRI is mandatory\n* 11\\. Patients with at least 1 measurable lesion, as defined by RECIST v1.1.\n* 12\\. Adequate hematologic and organ function.\n* 13\\. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention.\n* 14\\. Willingness and ability to comply with scheduled visits and study procedures\n* 15\\. For female patients of childbearing potential, a negative pregnancy test must have been documented prior to enrollment (within 14 days prior to enrollment).\n* 16\\. For female patients of childbearing potential, agreement (by patient and/or partner) to usea highly effective form(s) of contraception that results in a low failure rate (\\< 1% per year)when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib). No hormonal methods and preferably barrier method always containing a spermicide, intrauterine device (IUD): intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.\n* 17\\. For male patients with female partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception that results in a low failure rate \\[\\< 1% per year\\] when used consistently and correctly, and to continue its use for 7 days after the last dose of AMG510 (Sotorasib).\n* 18\\. Women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to enrollment.\n* 19\\. QTc interval must be ≤ 470 msec in females and ≤ 450 msec in males, based on the average obtained from three ECG.\n\nExclusion Criteria:\n\n* 1\\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations\n* 2\\. Weight loss \\>10% within the previous 3 months\n* 3\\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0\n* 4\\. Major surgery within 28 days of study day 1\n* 5\\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication\n* 6\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina\n* 7\\. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \\> 470ms\n* 8\\. Severe infections within 4 weeks prior to randomization including, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia\n* 9\\. Therapeutic oral or intravenous antibiotics within 2 weeks prior to randomization\n* 10\\. Patients with any concomitant and uncontrolled medical disorder\n* 11\\. Patients with vena cava syndrome\n* 12\\. Malignant pleural or pericardial effusion: both will be considered as suggestive of metastaticdisease. Also, are excluded those with negative cytology but being exudates. Patients with non-visible by thoracic X-ray pleural effusion or too small to be safely punctured could be included.\n* 13\\. Prior treatment with anti-neoplasic drugs\n* 14\\. Malignancies other than NSCLC within 3 years prior to enrollment\n* 15\\. Women who are pregnant, lactating, or intending to become pregnant during the study.\n* 16\\. Positive test for HIV. All patients will be tested for HIV prior to inclusion into the study; patients who test positive for HIV will be excluded from the clinical study.\n* 17\\. Patients with active hepatitis B or hepatitis C.\n* 18\\. Active tuberculosis.\n* 19\\. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications.\n* 20\\. Patients with illnesses or conditions that interfere with their capacity to understand follow and/or comply with study procedures.\n* 21\\. Known or suspected hypersensitivity to drugs with similar chemical structures to the study drug\n* 22\\. Evidence of any other disorder or significant laboratory finding that makes the patient undesirable to participate in the study\n* 23\\. Use of strong inducers of CYP3A4 within 14 days of half-lives (whichever is longer) prior to study day 1\n* 24\\. Use of proton pump inhibitors within 14 days to study day","locations":[{"facility":"Hospital General Universitario de Alicante","city":"Alicante","state":"Alicante","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICO Badalona, Hospital Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Quiron Dexeus","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d' Hebron","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Parc Taulí","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital De Basurto","city":"Bilbao","state":"Bilbao","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICO Girona, Hospital Josep Trueta","city":"Girona","state":"Girona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Cecilio De Granada","city":"Granada","state":"Granada","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario De Jaén","city":"Jaén","state":"Jaén","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospitalario Universitario A Coruña","city":"A Coruña","state":"La Coruña","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Lucus Augusti","city":"Lugo","state":"Lugo","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Severo Ochoa","city":"Leganés","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Puerta de Hierro","city":"Majadahonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Son Espases","city":"Palma de Mallorca","state":"Mallorca","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Son Llatzer","city":"Palma de Mallorca","state":"Palma de Mallorca","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio","city":"Seville","state":"Sevilla","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario De Valencia","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Fe","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eva Pereira","phone":"934302006","email":"gecp@gecp.org"}],"primaryOutcomes":["Efficacy of the treatment in terms of the Progression Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["alicante-spain","badalona-spain","barcelona-spain","bilbao-spain","girona-spain","granada-spain","ja-n-spain","a-coru-a-spain","lugo-spain","legan-s-spain","madrid-spain","majadahonda-spain","palma-de-mallorca-spain","seville-spain","valencia-spain"],"enrichment":{"headline":"Phase 2: testing Sotorasib for Non-small Cell Lung Cancer Stage III","inPlainEnglish":"Open-label, non-randomly assigned, exploratory, phase II, multi-centre clinical trial. 43 unresectable stage III (IIIA-N2, IIIB, IIIC) KRAS p.G12C non-small cell lung cancer patients will be enrolled in this trial to measure the how well it works of induction treatment of AMG510 (Sotorasib) plus AMG510 (Sotorasib) treatment post-induction as measured by Progression Free Survival at 12 months.","whoItsFor":["Ages 18 Years to any","1\\. Male or female, aged ≤ 80 years old","2\\. how well you can do daily activities (ECOG score) of 0-1","3\\. Histologically or cytologically confirmed, unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology","4\\. Patients who have documentation of KRAS p.G12C prior to enrollment. This determination can be done either by solid or liquid biopsy","5\\. No prior treatment for unresectable Stage III (IIIA-N2, IIIB and IIIC) NSCLC","6\\. Having a life expectancy ≥ 12 weeks","7\\. Patients must be ineligible for concurrent chemo-radiotherapy because of:"],"whoShouldSkip":["1\\. Patients with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene, ALK translocations or ROS1 mutations","2\\. Weight loss \\>10% within the previous 3 months","3\\. Patients with uncontrolled neuropathy (sensory) grade 2 or greater regardless of cause according to CTCAE v5.0","4\\. Major surgery within 28 days of study day 1","5\\. Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication","6\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (ClassII or greater), myocardial infarction within 6 months prior to study day 1, unstable arrhythmias or unstable angina","7\\. Ongoing cardiac dysrhythmias of CTCAE grade ≥2, uncontrolled atrial fibrillation of any grade or QTcF interval \\> 470ms"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib. The registry lists allocation as na. Open-label, non-randomly assigned, exploratory, phase II, multi-centre clinical trial.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 19 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.972Z"},{"nctId":"NCT05398484","title":"Psilocybin Therapy in Advanced Cancer","officialTitle":"A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Effects of Psilocybin-assisted Psychotherapy on Psychiatric and Existential Distress in Advanced Cancer","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.","conditions":["Advanced Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Psilocybin 25 mgs"},{"type":"DRUG","name":"Niacin 100mg"},{"type":"BEHAVIORAL","name":"Psychotherapy"}],"enrollment":200,"startDate":"2023-05-24","completionDate":"2027-01-01","sex":"ALL","minAge":"21 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥ 21\n* Diagnosis of Advanced Cancer defined as:\n\n  * Solid tumors to include stage 3 or 4, metastatic illness, or recurrent illness\n  * Hematologic malignancies to include, but not limited to, Stage 3 or 4 non-Hodgkins lymphoma, late-stage multiple myeloma or second-line therapy for multiple myeloma, and all forms of acute myeloid leukemia\n* Functional Status defined as: Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60%\n* Clinically significant Anxiety defined as SIGH-A \\>17 at Screening\n* Have an identified support person: agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing\n* Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study. A person of childbearing potential is anyone assigned female or intersex at birth who has experienced menarche and who has not undergone surgical sterilization (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes.\n\nExclusion Criteria:\n\n* Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n  * Congestive heart failure\n  * Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450)\n  * Recent acute myocardial infarction or evidence of ischemia\n  * Malignant hypertension\n  * Congenital long QT syndrome\n  * Acute renal failure\n  * Severe hepatic impairment\n  * Respiratory failure\n* Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \\>140/90 mmHg.\n* Significant central nervous system (CNS) pathology. Some examples include:\n\n  * Primary or secondary cerebral neoplasm\n  * Epilepsy\n  * History of stroke\n  * Cerebral aneurysm\n  * Dementia\n  * Delirium\n* Primary psychotic or affective psychotic disorders. Some examples include current or past DSM-5 criteria for:\n\n  * Schizophrenia spectrum disorders\n  * Schizoaffective disorder\n  * Bipolar I with psychotic features\n  * Major Depressive Disorder with psychotic features\n* Family history of first-degree relative with psychotic or serious bipolar spectrum illness. Examples include first-degree relative with:\n\n  * Schizophrenia spectrum disorders\n  * Schizoaffective disorder\n  * Bipolar I with psychotic features\n* High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include:\n\n  * Agitation\n  * Violent behavior\n* Active substance use disorders (SUDs) defined as: DSM-5 criteria for alcohol or drug use disorder (excluding caffeine and nicotine) within the past year\n* Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as:\n\n  * Any use in the last 12 months\n  * \\>25 lifetime uses\n* Clinically significant suicidality or high risk of completed suicide defined as:\n\n  * Active suicidal behavior (interrupted or aborted attempt; preparatory acts) as assessed by Baseline Version of C-SSRS. If C-SSRS items are 4 or 5, participant is ineligible\n  * History of suicide attempt(s) within the past year\n  * Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior\n* History of hallucinogen persisting perception disorder (HPPD)\n* Cognitive impairment as defined by: Montreal Cognitive Assessment Test (MoCA) \\< 23\n* Concurrent Medications\n\n  * Antidepressants\n  * Centrally-acting serotonergic agents (e.g., MAO inhibitors)\n  * Antipsychotics (e.g., first and second generation)\n  * Mood stabilizers (e.g., lithium, valproic acid)\n  * Aldehyde dehydrogenase inhibitors (e.g., disulfiram)\n  * Significant inhibitors of UGT 1A0 or UGT 1A10\n  * Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study\n* Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n  * Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n  * Note: Prescribed benzodiazepine medications and non-benzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n  * Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n  * Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study.\n* Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin\n* Participants who are pregnant, as indicated by a positive urine pregnancy test at Screening, Baseline, or prior to dosing on medication administration sessions. Participants who intend to become pregnant during the study or who are currently nursing.\n* Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n* Have an allergy or intolerance to any of the materials contained in either drug product\n* Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)","locations":[{"facility":"University of Colorado Anschutz Medical campus (CU AMC)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tallulah Laska","phone":"212-263-6283","email":"Tallulah.laska@nyulangone.org"},{"name":"Stephen Ross, MD","phone":"212-263-6289","email":"stephen.ross@nyulangone.org"}],"primaryOutcomes":["Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["aurora-colorado","new-york-new-york"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Psilocybin 25 mgs for Advanced Cancer","inPlainEnglish":"The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active dummy treatment (placebo) (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.","whoItsFor":["Ages 21 Years to 100 Years","Diagnosis of Advanced Cancer defined as:","Solid tumors to include stage 3 or 4, metastatic illness, or recurrent illness","Hematologic malignancies to include, but not limited to, Stage 3 or 4 non-Hodgkins lymphoma, late-stage multiple myeloma or second-line therapy for multiple myeloma, and all forms of acute myeloid leukemia","Functional Status defined as: Eastern Cooperative Oncology Group (ECOG) ≤2 and Palliative Performance Scale (PPS) ≥60%","Clinically significant Anxiety defined as SIGH-A \\>17 at Screening","Have an identified support person: agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing"],"whoShouldSkip":["Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:","Congestive heart failure","Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450)","Recent acute myocardial infarction or evidence of ischemia","Malignant hypertension","Congenital long QT syndrome","Acute renal failure"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 25 mgs, Niacin 100mg, or Psychotherapy. The registry lists allocation as randomized. The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active dummy treatment (placebo) (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.099Z"},{"nctId":"NCT05408845","title":"Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers","officialTitle":"A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NRG Oncology","sponsorClass":"OTHER","summary":"This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called trastuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.","conditions":["Metastatic Salivary Gland Carcinoma","Recurrent Salivary Gland Carcinoma","Stage III Major Salivary Gland Cancer AJCC v8","Stage IV Major Salivary Gland Cancer AJCC v8","Unresectable Salivary Gland Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Docetaxel"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"BIOLOGICAL","name":"Trastuzumab"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"},{"type":"BIOLOGICAL","name":"Trastuzumab Emtansine"}],"enrollment":146,"startDate":"2023-03-03","completionDate":"2028-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)\n\n  * HER2-positive cohort:\n\n    * Note: The majority of HER2-positive SGCs are salivary duct carcinoma (SDCs), but to a lesser extent, other SGC subtypes can be HER2-positive (e.g., adenocarcinomas, mucoepidermoid carcinomas, etc.) and are eligible to be included on the study. Additionally, pathologists may sign out SDCs under other descriptors (e.g., ex-pleomorphic adenoma, adenocarcinoma), and these would be eligible if they are HER2-positive.\n    * Note: HER2 evaluation based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation sequencing (NGS) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for \"HER2-positive\":\n\n      * Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines\n      * Gene amplification by FISH (HER2/CEP17 ratio \\>= 2.0)\n      * Gene amplification by NGS (fold change \\>= 2)\n  * HER2-low expressing cohort:\n\n    * Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescent in-situ hybridization (FISH) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for \"HER2-low\":\n\n      * IHC 1+ per the College of American Pathologists (CAP) breast cancer guidelines\n      * IHC 2+ without evidence of amplification by FISH\n* Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease that is evident on radiologic imaging\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* HER2-positive cohort: Measurable or non-measurable disease by the RECIST v1.1 criteria. HER2-low expressing cohort: Measurable disease by the RECIST v1.1 criteria\n* History/physical examination within 30 days prior to registration\n* The following imaging within 60 days prior to registration:\n\n  * CT or MRI of the neck (diagnostic quality with contrast, unless contraindicated) AND\n  * CT scan of the chest (diagnostic quality with contrast, unless contraindicated) AND\n  * If clinically indicated, CT or MRI of the abdomen and pelvis (diagnostic quality with contrast, unless contraindicated)\n* Age \\>= 18\n* Left ventricular ejection fraction (LVEF) \\>= 50% assessed by echocardiogram or multigated acquisition (MUGA) scan within 30 days prior to registration\n* Zubrod (Eastern Cooperative Oncology Group \\[ECOG\\]) Performance Status of 0-2 within 14 days prior to registration\n* Absolute neutrophil count (ANC) \\>= 1,500 cells/mm\\^3 (within 14 days prior to registration)\n* Platelets \\>= 100,000 cells/mm\\^3 (within 14 days prior to registration)\n* Hemoglobin \\>= 9.0 g/dL (within 14 days prior to registration)\n\n  * HER2-positive cohort: Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] \\>= 9.0 g/dL is acceptable\n  * HER2-low expressing cohort: Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (granulocyte colony-stimulating factor \\[G-CSF\\]) is not allowed\n* Serum creatinine =\\< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) \\>= 30 mL/min by the Cockcroft-Gault formula (within 14 days prior to registration)\n* HER2-positive cohort: Total bilirubin =\\< 1.5 x ULN (within 14 days prior to registration) (Not applicable to patients with known Gilbert's syndrome) (within 14 days prior to registration)\n* HER2-positive cohort: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\< 1.5 x ULN (within 14 days prior to registration)\n* HER2-low expressing cohort: Total bilirubin ≤ 1.5 x ULN if no liver metastases; or \\< 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases (within 14 days prior to registration) (within 14 days prior to registration)\n* HER2-low expressing cohort: AST and ALT ≤ 3 x ULN if no liver metastases; or \\< 5 x ULN with liver metastases (within 14 days prior to registration)\n* HER2-low expressing cohort: Serum albumin ≥ 2.5 g/dL (within 14 days prior to registration)\n* Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Testing is not required for entry into protocol\n* For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g., patients immunized against hepatitis B)\n* For patients with a known history of hepatitis C virus (HCV) infection, they must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\n  * Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal\n* Willing to use highly effective contraceptives for participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) during therapy and for 7 months following last dose of study drug; this inclusion is necessary because the treatment in this study may be significantly teratogenic. Women must refrain from donating eggs during this same period\n* Men with partners of childbearing potential must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period\n* Prior to registration, patients who have had chemotherapy or palliative-intent radiotherapy must have all toxicities related to prior treatment recovered to ≤ grade 1\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n\nExclusion Criteria:\n\n* HER2-positive cohort: Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting\n\n  * Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and/or concurrently with radiation is allowed\n* HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent or metastatic disease is not allowed\n* Severe, active co-morbidity defined as follows:\n\n  * Unstable angina requiring hospitalization in the last 6 months\n  * Myocardial infarction within the last 6 months\n  * New York Heart Association Functional Classification III/IV (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing\n  * Patient must not have an active infection requiring IV antibiotics, antivirals, or antifungals\n* HER2-positive cohort only: \\>= grade 3 peripheral neuropathy\n* Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on chest CT scan\n* Any hemorrhage or bleeding event grade \\>= 3 within 28 days prior to registration\n* History of allergic reactions to compounds of similar chemical or biologic composition to: HER2-positive cohort: ado-trastuzumab emtansine, trastuzumab, and/or docetaxel (or any of their excipients). HER2-low expressing cohort: DS-8201a (trastuzumab deruxtecan), trastuzumab\n* History of exposure to the following cumulative doses of anthracyclines:\n\n  * Doxorubicin or liposomal doxorubicin \\> 500 mg/m\\^2\n  * Epirubicin \\> 900 mg/m\\^2\n  * Mitoxantrone \\> 120 mg/m\\^2\n  * Note: If another anthracycline, or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of doxorubicin 500 mg/m\\^2\n* HER2-low expressing cohort only: Receipt of live, attenuated vaccine (messenger ribonucleic acid \\[mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of DS-8201a (trastuzumab deruxtecan)\n* Pregnancy and individuals unwilling to discontinue nursing","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fresno","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Modesto","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute Palo Alto","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Roseville","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Downtown Commons","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center-Mission Bay","city":"San Francisco","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Teresa-San Jose","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente San Leandro","city":"San Leandro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser San Rafael-Gallinas","city":"San Rafael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Medical Center - 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Minocqua","city":"Minocqua","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth D N Greenwald Center","city":"Mukwonago","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Oconomowoc Memorial Hospital","city":"Oconomowoc","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Rice Lake","city":"Rice Lake","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-River Region at Stevens Point","city":"Stevens Point","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UW Cancer Center at ProHealth Care","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Progression free survival (PFS) (HER2-Positive Cohort)","Objective response rate (ORR) (HER2-Low Expressing Cohort)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["birmingham-alabama","duarte-california","dublin-california","fremont-california","fresno-california","irvine-california","modesto-california","oakland-california","palo-alto-california","roseville-california","sacramento-california","san-francisco-california","san-jose-california","san-leandro-california","san-rafael-california","santa-clara-california","santa-rosa-california","south-san-francisco-california","vallejo-california","walnut-creek-california","aurora-colorado","highlands-ranch-colorado","miami-florida","atlanta-georgia","honolulu-hawaii","boise-idaho","fruitland-idaho","meridian-idaho","nampa-idaho","twin-falls-idaho","danville-illinois","effingham-illinois","mattoon-illinois","shiloh-illinois","urbana-illinois","ames-iowa","ankeny-iowa","carroll-iowa","clive-iowa","des-moines-iowa","fort-dodge-iowa","waukee-iowa","west-des-moines-iowa","hays-kansas","kansas-city-kansas","lawrence-kansas","olathe-kansas","overland-park-kansas","salina-kansas","topeka-kansas","westwood-kansas","lexington-kentucky","cumberland-maryland","boston-massachusetts","ann-arbor-michigan","detroit-michigan","farmington-hills-michigan","bemidji-minnesota","coon-rapids-minnesota","edina-minnesota","minneapolis-minnesota","rochester-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","city-of-saint-peters-missouri","creve-coeur-missouri","kansas-city-missouri","lees-summit-missouri","st-louis-missouri","lebanon-new-hampshire","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","albuquerque-new-mexico","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","bismarck-north-dakota","fargo-north-dakota","cincinnati-ohio","columbus-ohio","steubenville-ohio","west-chester-ohio","lawton-oklahoma","oklahoma-city-oklahoma","altoona-pennsylvania","beaver-pennsylvania","butler-pennsylvania","camp-hill-pennsylvania","carlisle-pennsylvania","cranberry-township-pennsylvania","erie-pennsylvania","farrell-pennsylvania","greensburg-pennsylvania","harrisburg-pennsylvania","indiana-pennsylvania","johnstown-pennsylvania","mckeesport-pennsylvania","mechanicsburg-pennsylvania","monroeville-pennsylvania","moon-township-pennsylvania","mount-pleasant-pennsylvania","n-huntingdon-pennsylvania","natrona-heights-pennsylvania","new-castle-pennsylvania","pittsburgh-pennsylvania","seneca-pennsylvania","uniontown-pennsylvania","washington-pennsylvania","williamsport-pennsylvania","york-pennsylvania","charleston-south-carolina","sioux-falls-south-dakota","nashville-tennessee","salt-lake-city-utah","saint-johnsbury-vermont","richmond-virginia","issaquah-washington","seattle-washington","eau-claire-wisconsin","marshfield-wisconsin","milwaukee-wisconsin","minocqua-wisconsin","mukwonago-wisconsin","oconomowoc-wisconsin","rice-lake-wisconsin","stevens-point-wisconsin","waukesha-wisconsin","weston-wisconsin"],"enrichment":{"headline":"Phase 2: testing Docetaxel for Metastatic Salivary Gland Carcinoma","inPlainEnglish":"This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer.","whoItsFor":["Ages 18 Years to any","Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)","HER2-positive cohort:","Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines","Gene amplification by FISH (HER2/CEP17 ratio \\>= 2.0)","Gene amplification by NGS (fold change \\>= 2)","HER2-low expressing cohort:","Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescent in-situ hybridization (FISH) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for \"HER2-low\":"],"whoShouldSkip":["HER2-positive cohort: Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting","Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and/or concurrently with radiation is allowed","HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent or metastatic disease is not allowed","Severe, active co-morbidity defined as follows:","Unstable angina requiring hospitalization in the last 6 months","Myocardial infarction within the last 6 months","Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing"],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 146 people at 154 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.350Z"},{"nctId":"NCT05411718","title":"A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome","officialTitle":"A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.","conditions":["T Cells","Colorectal Cancer","Lynch Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Naproxen"},{"type":"DRUG","name":"Aspirin"}],"enrollment":40,"startDate":"2023-03-21","completionDate":"2029-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have Lynch syndrome defined as meeting any of the following:\n\n  1. \"Mutation-Positive Lynch syndrome\": carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR) genes (i.e., MLH1, MSH2/EPCAM, MSH6, or PMS2).\n  2. \"Mutation-Negative Lynch syndrome\": patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e., polyp) or a non-sporadic MMR deficient malignant tumor (where \"non-sporadic MMR deficient\" is defined by: microsatellite-instability high by either immunohistochemistry or MSI testing or both, but no evidence of MLH1 promoter methylation in cases with loss of both MLH1 and PMS2, and/or no evidence of BRAF mutation in cases with loss of both MLH1 and PMS2) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic test-ing.\n* Participants must not have evidence of active/recurrent malignant disease for 6 months.\n* Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation).\n* Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e., partici-pants must have at least part of the descending/sigmoid colon and/or rectum intact).\n* Participants must consent to one standard of care lower GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be 12 months (+14 days) apart.\n* Participants must consent to refrain from using aspirin or NSAIDs or COX-inhibitors for the du-ration of the trial\n* Age ≥18 years. Because no dosing or adverse event data are currently available on the long-term use of naproxen or aspirin in patients \\<18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable.\n* ECOG performance status ≤1 OR Karnofsky ≥70%; see Appendix A.\n* Participants must have normal organ and marrow function as defined below:\n\nHemoglobin \\>10 g/dL or Hematocrit \\> 30 % Leukocyte count ≥3,000/microliter Platelet count ≥100,000/microliter Absolute neutrophil count ≥1,500/microliter Creatinine ≤1.5 x institutional ULN (OR GFR \\>30ml/min/1.73m2) Total bilirubin ≤2 x institutional ULN AST (SGOT) ≤2.5 × institutional ULN ALT (SGPT) ≤2.5 × institutional ULN\n\n* The effects of naproxen on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because NSAIDs are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant at the time of study entry or while participating in this study, she should inform her study physician immediately. Women of childbearing potential must agree to base-line and pre-drug pregnancy tests.\n* Ability to understand and the willingness to sign a written informed consent document.\n* Willing and able to adhere to the prohibitions and restrictions specified in the final approved pro-tocol.\n* Willing to undergo yearly standard of care screening colonoscopy for the duration of the clinical trial.\n\nExclusion Criteria:\n\n* Individuals with presence of two somatic mutations/loss of heterozygosity (LOH) in one of the four MMR genes (MLH1, MSH2, MSH6, and PMS2) in MMR-deficient neoplasm (defined as a tumor with MSI-H by PCR analysis or loss of staining in one of the four MMR proteins).\n* Individuals who received scheduled NSAIDs or COX-inhibitors of any kind for \\>3 days during anytime within the 2 weeks prior to baseline eligibility screening visit. By exception, individuals receiving cardio-protective aspirin (e.g., 81 mg PO daily) will be eligible provided they are will-ing to stop no less than 7 days prior to starting on naproxen or aspirin in this study.\n* Individuals who are status post total proctocolectomy (i.e., removal of all colon and rectum).\n* Individuals with active gastroduodenal ulcer disease in the preceding 5 years.\n* Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction. If any of these events had been due to a malignancy of the GI tract and the malignancy has since been removed, the patient is eligible.\n* Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years.\n* Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than 7 days prior to starting naproxen or aspirin on this study. Consultation with the participant's primary care provider may be obtained but is not required. The use of the following drugs or drug classes is prohibited during naproxen/aspirin treatment:\n\n  * Investigational agents;\n  * NSAIDs: such as ketorolac, sulindac, ibuprofen, and others;\n  * COX-2 inhibitors: such as Celecoxib, Rofecoxib and other COX-2;\n  * Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofi-ban, eptifibatide and prasugrel;\n  * Anticoagulants:\n\n    * Heparin;\n    * Heparinoids: such as fondaparinux, danaparoid and other heparinoids;\n    * Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepidurin, bivalidurin;\n    * Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, aceno-coumarol, dicumarol, phenindione and other anticoagulants;\n  * Lithium;\n  * Selective serotonin and norepinephrine reuptake inhibitors: minalcipran, fluoxetine, paroxe-tine, nefazadine, citalopram, clovoxamine, escitalopram, flesinoxan, femoxitene, duloxetine, venlafaxine, vilazodone, sibutramine, desvenlafaxine;\n  * Anticonvulsants: phenytoin, parakdehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenac-emide, mephobarbital, oxcarbazepine, zonisamide, piracetam, vigabatrin, felbamate, gabapentin, beclamide, phosphenytoin, stripentol, tiagabine, topiramate, pregabalin, lacosa-mide, rufinamide, caramiphen;\n  * Antibiotics and antifungals:\n\n    o Fluorquinolones: such as ofloxacin, norfloxacin, levofloxacin;\n  * Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, fe-verfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrex-ate, pralatrexate.\n* Individuals with uncontrolled renal insufficiency or renal failure.\n* History of allergic reactions attributed to naproxen or aspirin.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncon-trolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac ar-rhythmia, or psychiatric illness/social situations that would limit compliance with study require-ments.\n* Pregnant, breast-feeding, or women of childbearing potential unwilling to use a reliable contra-ceptive method. Pregnant women are excluded from this study because Naproxen/NSAIDs is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with naproxen or aspirin, breastfeeding should be discontinued if the mother is treated with naproxen.\n\nInclusion of Women and Minorities:\n\n-Participants will be adult men and women of all races and ethnic groups, who are at least 18 years old, and who are deemed eligible for this trial. Children will not be recruited to the trial.\n\nOur minority recruitment strategies will include identifying participants through the University of Texas MD Anderson Cancer Center Familial High-Risk Gastrointestinal Cancer Clinic and Weill Cornell Med-ical College. We will advertise the study on minority and other national websites.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eduardo Vilar-Sanchez, MD","phone":"(713) 563-4743","email":"evilar@mdanderson.org"}],"primaryOutcomes":["To establish the effect of naproxen or aspirin on the abundance of T cells and other immune"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Naproxen for T Cells","inPlainEnglish":"To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.","whoItsFor":["Ages 18 Years to any","Participants must have Lynch syndrome defined as meeting any of the following:","\"Mutation-Positive Lynch syndrome\": carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR) genes (i.e., MLH1, MSH2/EPCAM, MSH6, or PMS2)","Participants must not have evidence of active/recurrent malignant disease for 6 months","Participants must be at least 6 months from any prior cancer-directed treatment (such as surgical resection, chemotherapy, immunotherapy, hormonal therapy or radiation)","Participants must have endoscopically accessible distal colon and/or rectal mucosa (i.e., partici-pants must have at least part of the descending/sigmoid colon and/or rectum intact)","Participants must consent to one standard of care lower GI endoscopy (flexible sigmoidoscopy or colonoscopy) with biopsies and one flexible sigmoidoscopy with biopsies that will be 12 months (+14 days) apart","Participants must consent to refrain from using aspirin or NSAIDs or COX-inhibitors for the du-ration of the trial"],"whoShouldSkip":["Individuals with presence of two somatic mutations/loss of heterozygosity (LOH) in one of the four MMR genes (MLH1, MSH2, MSH6, and PMS2) in MMR-deficient neoplasm (defined as a tumor with MSI-H by PCR analysis or loss of staining in one of the four MMR proteins)","Individuals who are status post total proctocolectomy (i.e., removal of all colon and rectum)","Individuals with active gastroduodenal ulcer disease in the preceding 5 years","Individuals with any history of transfusion-dependent gastrointestinal bleeding, gastrointestinal perforation or gastrointestinal obstruction. If any of these events had been due to a malignancy of the GI tract and the malignancy has since been removed, the patient is eligible","Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years","Investigational agents;","NSAIDs: such as ketorolac, sulindac, ibuprofen, and others;"],"whatHappens":"If you join, the listed intervention(s) are Naproxen, or Aspirin. The registry lists allocation as randomized. To learn about the effects of naproxen and aspirin on the normal colon in people with Lynch Syndrome.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.082Z"},{"nctId":"NCT05418868","title":"A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants","officialTitle":"A Phase I, Multi-centre, Open-label, Single Dose Escalation Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Long-acting Cabotegravir Co-administered With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"ViiV Healthcare","sponsorClass":"INDUSTRY","summary":"This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \\>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \\>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.","conditions":["HIV Infections"],"keywords":["Cabotegravir (CAB)","Rilpivirine (RPV)","Long-Acting Injection","Pharmacokinetics","Safety","Tolerability"],"interventions":[{"type":"DRUG","name":"Cabotegravir 200 mg/mL"},{"type":"DRUG","name":"CAB >=400 mg/mL"},{"type":"DRUG","name":"CAB Formulation I"},{"type":"DRUG","name":"CAB Formulation J"},{"type":"DRUG","name":"rHuPH20"},{"type":"DRUG","name":"RPV"}],"enrollment":214,"startDate":"2022-06-14","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* At the time of obtaining informed consent, participants age should be greater than or equal to (\\>=)18 years and less than or equal to (\\<=) 55 years.\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Body weight \\>=40 kilogram (kg) and body mass index (BMI) within the range \\>=18 to \\<=32 kilogram per meter square (kg/m\\^2).\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving written informed consent.\n\nExclusion Criteria:\n\n* Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n* History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period.\n* Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test.\n* History of or on-going high-risk behaviors that, in the opinion of the investigator, may put the participant at increased risk for HIV infection including, but not limited to, participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n* Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.\n* Abnormal blood pressure.\n* Evidence of previous myocardial infarction.\n* Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular \\[AV\\] block \\[2nd degree or higher\\], Wolff- Parkinson-White \\[WPW\\] syndrome).\n* Any significant arrhythmia which, in the opinion of the investigator or the medical monitor, will interfere with the safety for the individual participant.\n* One or more exclusionary values for a screening Electrocardiogram (ECG).\n* Alanine transaminase (ALT) \\>upper limit of normal (ULN). - Bilirubin \\>1.5xULN (isolated bilirubin \\>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \\<35 percent \\[%\\]).\n* Estimated Glomerular Filtration Rate (eGFR) \\<60 milliliter per minute (mL/min) using the Chronic Kidney Disease - Improved Prediction Equations (CKD-EPI) Creatinine Equation (2021).\n* Hemoglobin \\<12.5 gram per deciliter (g/dL) for men and \\<11 g/dL for women.\n* Positive pre-study drug/alcohol screen.\n* Regular use of tobacco- or nicotine-containing products within 3 months prior to screening; or urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products (e.g., nicotine patches or vaporizing devices).\n* Regular alcohol consumption within 6 months prior to the study defined as an average weekly intake of \\>14 units for males or \\>7 units for females.\n* Regular use of known drugs of abuse.\n* Concurrent participation in another clinical trial (except imaging trials); or has participated in a clinical trial and received an investigational product within the following time period prior to the first dosing day in this study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).\n* Participation in the study would result in loss of blood or blood products in excess of 500 mL within 56 days.\n* Exposure to more than four (4) new chemical entities within 12 months prior to the first dosing day.\n* History of sensitivity to any of the study interventions (or components thereof), a history of drug allergy or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation, including a known hypersensitivity to hyaluronidases.\n* Current or anticipated need for chronic anti-coagulation therapy.\n* Hereditary coagulation and platelet disorders (e.g., hemophilia or Von Willebrand disease \\[VWD\\]).\n* Participant has a tattoo overlying the location of injection or an underlying skin disease or condition (e.g., infection, inflammation, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria) that, in the opinion of the investigator, may interfere with interpretation of injection site reactions or administration of study intervention.\n* Any other clinical condition, behavior or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n* Participant who in the investigator's judgment poses a significant suicidality risk. Participant's history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk.\n* Fasting glucose \\>125 mg/dL (6.95 mmol/L; Grade \\>2) or in treatment for elevated blood glucose.\n* Triglycerides \\>500 mg/dL (5.7 mmol/L; Grade \\>3) or in treatment for dyslipidemia.","locations":[{"facility":"GSK Investigational Site","city":"Orlando","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Maximum observed plasma concentration (Cmax) of CAB and RPV","Time of maximum observed plasma concentration (tmax) of CAB and RPV","Area under the concentration - time curve from time zero to infinity (AUC[0-inf]) of CAB and RPV","Area under the concentration - time curve from time zero to time of last quantifiable concentration or 4 weeks following the injection whichever is earlier (AUC[0-t]) of CAB and RPV","Area under the concentration - time curve from time zero to last quantifiable time point or 8 weeks following the injection whichever is earlier [AUC(0-t)]","Plasma Concentration of CAB and RPV at Week 4","Plasma Concentration of CAB and RPV at Week 8","Plasma Concentration of CAB and RPV at Week 12","Plasma Concentration of CAB and RPV at Week 16","Plasma Concentration of CAB and RPV at Week 24","Plasma Concentration of RPV at Week 32","Plasma Concentration of CAB at Week 36","Plasma Concentration of RPV at Week 40","Plasma Concentration of CAB and RPV at Week 48","Plasma Concentration of CAB","Plasma Concentration of RPV at Week 56","Plasma Concentration of RPV at Week 64","Plasma Concentration of RPV at Week 72","Apparent terminal phase half-life (t1/2) of CAB and RPV","Apparent long-acting absorption rate constant (KA-LA) of CAB and RPV","Number of Participants with Non-serious Adverse Events (non-SAEs) and Serious Adverse Events (SAEs)","Number of Participants with AEs by Severity","Absolute value of hematology parameter: Platelet count (cells per microliter)","Absolute values of hematology parameters: Reticulocytes (Percentage of reticulocytes)","Absolute values of hematology parameters: Hematocrit (Proportion of red blood cells in blood)","Absolute values of hematology parameters: Hemoglobin (Hgb) (grams per deciliter)","Absolute value of hematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)","Absolute value of hematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)","Absolute value of hematology parameter: Mean Corpuscle Hemoglobin (MCH) (Picograms)","Absolute values of hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per liter)","Absolute values of Clinical Chemistry parameters: Glucose (fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)","Absolute values of Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)","Absolute values of Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)","Change from Baseline in hematology parameter: Platelet count (cells per microliter)","Change from Baseline in hematology parameters: Reticulocytes (Percentage of reticulocytes)","Change from Baseline in hematology parameters: Hematocrit (Proportion of red blood cells in blood)","Change from Baseline in hematology parameters: Hgb (grams per deciliter)","Change from Baseline in hematology parameter: RBC Count (million cells per microliter)","Change from Baseline in hematology parameter: MCV (Femtoliters)","Change from Baseline in hematology parameter: MCH (picograms)","Change from Baseline in hematology parameters: Differential count of Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (Giga cells per liter)","Change from Baseline in Clinical Chemistry parameters: Glucose (fasting), BUN, Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per deciliter)","Change from Baseline in Clinical Chemistry parameters: AST/SGOT, ALT/ SGPT, ALP and CPK (International Units per liter)","Change from Baseline in Clinical chemistry parameters: Albumin and Total Protein (Grams per deciliter)","Number of participants with maximum toxicity grades increase from Baseline in hematology and clinical chemistry"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["orlando-florida","las-vegas-nevada","austin-texas"],"enrichment":{"headline":"Phase 1: testing Cabotegravir 200 mg/mL for HIV Infections","inPlainEnglish":"This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \\>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.","whoItsFor":["Ages 18 Years to 55 Years","Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring","Body weight \\>=40 kilogram (kg) and body mass index (body-mass index (BMI)) within the range \\>=18 to \\<=32 kilogram per meter square (kg/m\\^2)","Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies"],"whoShouldSkip":["Current presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders","Current or chronic history of liver disease or known hepatic or biliary abnormalities","History of ongoing or clinically relevant seizure disorder within the previous 2 years, including participants who have required treatment for seizures within this time period","Human immunodeficiency virus (HIV-1 or HIV-2) infection as indicated by positive antibody/antigen test","Presence of hepatitis B surface antigen (HBsAg), or positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment","Abnormal blood pressure","Evidence of previous myocardial infarction"],"whatHappens":"If you join, the listed intervention(s) are Cabotegravir 200 mg/mL, CAB >=400 mg/mL, or CAB Formulation I. The registry lists allocation as randomized. This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \\>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 214 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.536Z"},{"nctId":"NCT05419024","title":"Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption","officialTitle":"Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nHuman immunodeficiency virus (HIV) infects CD4 T cells. There is no cure for HIV. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection. ART stops HIV from infecting cells, but HIV does not go away. Some infected cells remain. If ART is stopped, then HIV levels will rise and infect more cells.\n\nObjective:\n\nTo compare changes in the amount of virus in blood and lymph nodes after a short treatment interruption.\n\nEligibility:\n\nAdults aged 18 years or older who are undergoing ART for HIV infection.\n\nDesign:\n\nParticipants will be screened with a physical exam, including blood tests. They will be assigned to 1 of 2 groups:\n\nOne group will stay on ART. They will have 2 study visits: the first 45 days after screening, and the second 12 to 16 weeks later. They will have a PET/CT scan at each visit. A substance called a tracer will be injected into their arm. They will lie still on a table that moves through a doughnut-shaped machine. This process takes up to 2 hours.\n\nThe other group will stop ART for no more than 90 days. This group will have 3 PET/CT scans over 8 months. Once they stop ART, they will visit the clinic weekly for blood tests. After restarting ART, they will continue to visit the clinic weekly until their HIV level is safe.\n\nAll participants will have small samples of tissue taken from lymph nodes. They may also opt to provide semen samples or vaginal fluid. They may have samples taken of bone marrow or the fluid inside their spinal column....","conditions":["HIV"],"keywords":["Human Immunodeficiency Virus","Antiretroviral Therapy","FDG-PET","Reservoir"],"interventions":[{"type":"OTHER","name":"Acute Treatment Interruption"}],"enrollment":50,"startDate":"2023-01-09","completionDate":"2029-08-01","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants must meet all of the following criteria to be eligible for this study:\n\n1. Aged \\>=18 years.\n2. People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies.\n3. Established medical care outside NIH.\n4. Able to provide informed consent.\n5. Willing to allow samples to be stored for future research.\n6. Willing to allow genetic testing.\n7. Undergoing cART using recommended, alternative, or other regimens as defined by \"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.\"\n8. Viral RNA \\<40 copies/mL plasma by conventional assay for at least 3 years (blips \\[transient increases within 6 weeks\\] of \\<200 copies/mL are allowable when succeeding viral levels return to \\<40 copies/mL on subsequent testing).\n9. CD4 cell count \\>=350 cells/microliter.\n10. Willing to interrupt ART for up to 90 days.\n11. Willing to use a barrier method of contraception, such as condoms or dental dams, when engaging in sexual activity, or remain abstinent during ATI and after re-initiating ART until viral re-suppression is achieved, to prevent pregnancy and transmission of HIV.\n\nEXCLUSION CRITERIA:\n\nParticipants who meet any of the following criteria will be excluded from this study:\n\n1. Active intercurrent illness or infection, including fever \\>38 degrees Celsius.\n2. Known history of initiating ART during the first year of infection with HIV. Participants will be considered to have initiated ART within 1 year of infection as defined by documented screening/confirmatory seroconversion (positive testing within one year of non-reactive HIV enzyme-linked immunosorbent assay).\n3. Pregnant.\n4. Breastfeeding.\n5. Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG, including prednisolone, valproate carbamazepine, phenytoin, phenobarbital, and catecholamines.\n6. Undergoing ART that is incompatible with an ATI.\n7. Has undergone PET/CT within the last 6 months.\n8. History of poorly controlled diabetes that, in the judgement of the investigators, would prevent completion of PET/CT scan.\n9. Vaccination within the previous 4 weeks.\n10. History of ATI within the past 1 year.\n11. Has comorbid illness for which, in the judgment of the investigators, an ATI will represent elevated risk.\n12. Active opportunistic infection as defined by the Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV.\n13. Significant active substance abuse or psychiatric illness that may, in the judgment of the investigator, interfere with study visits or procedures.\n14. Allergy to planned anesthetic agents that are expected to be used. For local anesthetics, this is lidocaine. For sedation, this is midazolam and fentanyl.\n15. Currently undergoing chronic systemic steroid therapy (corticosteroid nasal spray or inhaler, topical steroid use, and hormone replacement are acceptable).\n16. Contraindication to use of IV contrast.\n17. History of developing keloids.\n18. Renal impairment: HIV-related kidney disease or estimated glomerular filtration rate (eGFR) CKD-EPI equation \\<60 mL/min/1.73 m\\^2. For individuals undergoing therapy with cobicistat or integrase strand inhibitors, GFR may be estimated using cystatin C or creatinine.\n19. Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both.\n20. Active hepatitis C virus infection, with detectable virus RNA.\n21. History of HIV-associated dementia or progressive multifocal leukoencephalopathy.\n22. Documented ARV drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study.\n23. History of cardiovascular event or at high risk of an event (e.g., atherosclerotic cardiovascular disease score \\>20%) by a currently accepted risk calculator such as the 2023 AHA Predicting Risk of Cardiovascular Disease Events (PREVENT) or the 2018 ASCVD Risk Estimator Plus.\n24. History of AIDS-defining illness according to CDC criteria within the past 3 years.\n25. Hepatic impairment: aminotransferase \\>2.5 x the upper limit of normal or documented history of cirrhosis.\n26. Any condition that, in the judgment of the investigator, contraindicates participation in this study.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chuen-Yen C Lau, M.D.","phone":"(240) 858-7088","email":"lauc@mail.nih.gov"}],"primaryOutcomes":["Fold increase in HIV nucleic acids (RNA and DNA) in blood or lymphoid compartments from baseline to 10 day ATI vs baseline to no ATI."],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: Acute Treatment Interruption for HIV","inPlainEnglish":"Background: Human immunodeficiency virus (HIV) infects CD4 T cells. People with HIV need to take daily medications called antiretroviral therapy (ART) to control their infection.","whoItsFor":["Ages 18 Years to 100 Years","Participants must meet all of the following criteria to be eligible for this study:","People with HIV-1 documented using US Food and Drug Administration-approved screening and confirmatory or supplemental assays in Centers for Disease Control and Prevention (CDC)-recommended testing strategies","Established medical care outside NIH","Willing to allow samples to be stored for future research","Willing to allow genetic testing","Undergoing cART using recommended, alternative, or other regimens as defined by \"Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV.\"","Viral RNA \\<40 copies/mL plasma by conventional assay for at least 3 years (blips \\[transient increases within 6 weeks\\] of \\<200 copies/mL are allowable when succeeding viral levels return to \\<40 copies/mL on subsequent testing)"],"whoShouldSkip":["Participants who meet any of the following criteria will be excluded from this study:","Active intercurrent illness or infection, including fever \\>38 degrees Celsius","Currently undergoing therapy with drugs that, in the judgment of the investigators, may interfere with biodistribution of FDG, including prednisolone, valproate carbamazepine, phenytoin, phenobarbital, and catecholamines","Undergoing ART that is incompatible with an ATI","Has undergone PET/CT within the last 6 months","History of poorly controlled diabetes that, in the judgement of the investigators, would prevent completion of PET/CT scan","Vaccination within the previous 4 weeks"],"whatHappens":"If you join, the listed intervention(s) are Acute Treatment Interruption. The registry lists allocation as randomized. Background: Human immunodeficiency virus (HIV) infects CD4 T cells.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.523Z"},{"nctId":"NCT05432804","title":"Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment","officialTitle":"A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Giving selinexor in combination with usual chemotherapy (temozolomide) may shrink or stabilize the tumor better than the usual chemotherapy with temozolomide alone in patients with recurrent glioblastoma.","conditions":["Recurrent Glioblastoma, IDH-Wildtype","Recurrent MGMT-Methylated Glioblastoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Placebo Administration"},{"type":"DRUG","name":"Selinexor"},{"type":"DRUG","name":"Temozolomide"}],"enrollment":97,"startDate":"2023-03-20","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) that has undergone resection or biopsy upon first recurrence. Recurrence at site of prior involvement is defined by histopathological evidence of viable neoplastic cells associated with any of the following: mitotic activity, increased proliferation rate, micro-endothelial proliferation, or pseudo-palisading necrosis\n* Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \\>= 2 axial slices\n* Patients must have received first-line treatment of temozolomide plus radiotherapy\n* Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \\< 18 years of age, children are excluded from this study\n* Karnofsky performance status \\>= 60% (Eastern Cooperative Oncology Group \\[ECOG\\] =\\< 2)\n* Absolute neutrophil count \\>= 1,500/mcL\n* Platelets \\>= 100,000/mcL\n* Hemoglobin \\>= 10 g/dL\n* Total bilirubin =\\< 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine transaminase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\< 3 x institutional ULN\n* Glomerular filtration rate (GFR) \\>= 30 mL/min/1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* The effects of selinexor (KPT-330) and temozolomide on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as deoxyribonucleic acid (DNA) alkylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, and for 180 days after the last dose of temozolomide. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of study treatment administration\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and/or family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy must have full recovery of organ and marrow function following the nadir of the last chemotherapy cycle\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Patients who have previously received bevacizumab\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or temozolomide\n* History of hypersensitivity to dacarbazine (DTIC), since both dacarbazine and temozolomide are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC)\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because selinexor (KPT-330) is a selective inhibitor of nuclear export with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with selinexor (KPT-330), breastfeeding is not allowed for mothers during treatment with selinexor (KPT-330) and for 7 days after the last dose. These potential risks may also apply to other agents used in this study\n* Hospitalized patients with severe coronavirus disease of 2019 (COVID-19) who are \\>= 75 years old, or with a high-risk COVID-GRAM score, or with lactate dehydrogenase (LDH) \\> 370 (U/L) AND D-Dimer \\> 600 mcg/L FEU should not receive low-dose selinexor (KPT-330) pending additional results","locations":[{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medicine of USC Koreatown","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Coral Gables","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Deerfield Beach","city":"Deerfield Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Miller School of Medicine-Sylvester Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital/Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medicine-Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky/Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cooperman Barnabas Medical Center","city":"Livingston","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers New Jersey Medical School","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Laura and Isaac Perlmutter Cancer Center at NYU Langone","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Health Sciences","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-UC Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-West Chester","city":"West Chester","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute/University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - Eastpark Medical Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - University Hospital","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Recommended phase 2 dose (RP2D) (Phase I)","Progression-free survival (PFS) (Phase II)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","duarte-california","irvine-california","la-jolla-california","los-angeles-california","orange-california","sacramento-california","aurora-colorado","coral-gables-florida","deerfield-beach-florida","jacksonville-florida","miami-florida","tampa-florida","atlanta-georgia","chicago-illinois","orland-park-illinois","lexington-kentucky","rochester-minnesota","livingston-new-jersey","new-brunswick-new-jersey","newark-new-jersey","buffalo-new-york","new-york-new-york","winston-salem-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","west-chester-ohio","oklahoma-city-oklahoma","pittsburgh-pennsylvania","salt-lake-city-utah","charlottesville-virginia","richmond-virginia","madison-wisconsin"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Placebo Administration for Recurrent Glioblastoma, IDH-Wildtype","inPlainEnglish":"This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE).","whoItsFor":["Ages 18 Years to any","Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \\>= 2 axial slices","Patients must have received first-line treatment of temozolomide plus radiotherapy","Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease","Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \\< 18 years of age, children are excluded from this study","Karnofsky performance status \\>= 60% (Eastern Cooperative Oncology Group \\[ECOG\\] =\\< 2)","Absolute neutrophil count \\>= 1,500/mcL","Platelets \\>= 100,000/mcL"],"whoShouldSkip":["Patients who have had chemotherapy must have full recovery of organ and marrow function following the nadir of the last chemotherapy cycle","Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia","Patients who are receiving any other investigational agents","Patients who have previously received bevacizumab","History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or temozolomide","History of hypersensitivity to dacarbazine (DTIC), since both dacarbazine and temozolomide are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC)","Patients with uncontrolled intercurrent illness"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Magnetic Resonance Imaging, or Placebo Administration. The registry lists allocation as randomized. This phase I/II trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 97 people at 39 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.471Z"},{"nctId":"NCT05436418","title":"The Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination With Sirolimus and Mycophenolate Mofetil as Graft-Versus-Host Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation","officialTitle":"Phase I/II Trial to Determine the Lowest Effective Dose of Post-Transplantation Cyclophosphamide in Combination w Sirolimus and Mycophenolate Mofetil as GVHD Disease Prophylaxis After Reduced Intensity Conditioning and Peripheral Blood Stem Cell Transplantation","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nBlood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers. Sometimes these transplants cause serious side effects, including a common immunologic problem called graft-versus-host disease. A drug called cyclophosphamide given early after the transplant (post-transplantation cyclophosphamide, PTCy) can reduce these complications. But sometimes this drug has its own negative effects. Furthermore, studies in mice suggest that an intermediate, rather than very high, dose of this drug may best protect against graft-versus-host disease.\n\nObjective:\n\nTo find out if a lower dose of PTCy is more helpful for people who undergo blood stem cell transplants.\n\nEligibility:\n\nPeople aged 18 and older who have a blood cancer and are eligible for a transplant of blood stem cells from another person. Healthy donors are also needed but must be related to the individual needing the transplant.\n\nDesign:\n\nParticipants will undergo screening. Transplant recipients will have imaging scans and tests of their heart and lung function. They will be assessed for the status of their cancer, including bone marrow taken from their pelvis and possibly also scans and/or fluid drawn from the spine depending on the disease type.\n\nDonors will be screened for general health. They will give several tubes of blood. They will give an oral swab and saliva and stool samples for research.\n\nRecipients will be in the hospital at least 4 to 6 weeks.\n\nThey will have a temporary catheter inserted into a vein in the chest or neck. Medications will be given and blood will be drawn through the catheter.\n\nThe transplanted stem cells will be given through the catheter. Participants will receive medications both before and after the transplant.\n\nParticipants will return to the clinic at least once a week for 3 months after leaving the hospital. Follow-up visits will continue periodically for 5 years.","conditions":["Peripheral Blood Stem Cell Transplantation","Hematopoietic Stem Cell Transplantation"],"keywords":["Reduced Intensity Conditioning","Systemic Immunosuppressive Therapy","Hematologic Malignancy","Acute Myeloid Leukemia","Calcineurin Inhibitor"],"interventions":[{"type":"DRUG","name":"Melphalan"},{"type":"DRUG","name":"Sirolimus"},{"type":"RADIATION","name":"Total Body Irradiation (TBI)"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Mycophenolate Mofeti"},{"type":"DRUG","name":"Fludarabine"},{"type":"PROCEDURE","name":"Allogeneic HSCT"},{"type":"DRUG","name":"Mesna"},{"type":"DRUG","name":"Filgrastim"}],"enrollment":260,"startDate":"2022-11-18","completionDate":"2027-06-25","sex":"ALL","minAge":"12 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nRecipient\n\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following:\n\n  * Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * AML of any risk in second or subsequent morphologic complete remission\n  * Acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>= 3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed within 1 year of completion of primary treatment, relapsed after autologous transplantation, or has progressed through at least 2 lines of therapy\n  * Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHV or refractory to or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on the Prognostic Index for T-cell lymphoma (PIT) score of low-intermediate risk or higher or on recently published clinical practice guidelines\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma, stage III, relapsing after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD)\n* Age \\>= 50 years or age 18-49 years and also meeting one of the following criteria:\n\n  * Prior myeloablative HCT\n  * Prior exposure to inotuzumab, gemtuzumab, or other agent that increases the risk for sinusoidal obstruction syndrome.\n  * Hematopoietic Cell Transplantation- Comorbidity Index (HCT-CI) \\>= 3\n  * Karnofsky performance score \\<80\n  * Co-morbidity considered by the treating physician to be exclusionary of myeloablative conditioning\n* At least one potentially suitable HLA-haploidentical or 10/10 (HLA-A, B, C, DR, DQ) related or unrelated donor for HCT\n* Karnofsky performance score \\>= 70\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction \\>= 45% by 2D ECHO;\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLCO) (corrected for hemoglobin) all of \\>= 50% predicted;\n  * Estimated serum creatinine clearance of \\>= 60 ml/minute/1.73m\\^2 calculated using eGFR in the clinical lab;\n  * Total bilirubin \\<= 2X the upper limit of normal;\n  * Alanine aminotransferase and aspartate aminotransferase \\<= 3X the upper limit of normal.\n* Individuals of child-bearing potential (IOCBP) and participants who can father children must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one year post-transplant.\n* IOCBP must have a negative serum or urine pregnancy test within 7 days prior to initiation of conditioning regimen.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nRecipient\n\n* Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning.\n* Active nursing.\n* Active malignancy of non-hematopoietic type (excluding non-melanoma skin cancers) which is: metastatic, or relapsed/refractory to treatment, or locally advanced and not amenable to curative treatment, or limited disease treated with curative intent treatment within the last 2 years. This excludes non-melanoma skin cancers.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents.\n* Uncontrolled intercurrent illness (e.g., severe endocrinopathy, disseminated intravascular coagulation, profound electrolyte disturbance, active infectious hepatitis, uncontrolled dental infection) that in the opinion of the Site PI would make it unsafe to proceed with transplantation.\n\nINCLUSION CRITERIA:\n\nDonor\n\n* Related (age \\>=12) and unrelated (age \\>=18) donors deemed eligible (i.e., evaluated at NIH, COH, and FHCC in accordance with existing institutional Standard Policies and Procedures or evaluated per the standards required by the IRB of the National Marrow Donor Program or applicable registry), and willing to donate research samples will be included.\n* Ability of participant or parent/legal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nDonor\n\nNone","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy H Chai","phone":"(240) 858-3755","email":"amy.chai@nih.gov"},{"name":"Christopher G Kanakry, M.D.","phone":"(240) 760-6171","email":"christopher.kanakry@nih.gov"}],"primaryOutcomes":["Phase II: Evaluate the efficacy of PTCy, at the lowest dose determined for each HLA-matching arm from phase I, as assessed by 1-year GVHD-free relapse-free survival (GRFS) rate.","Phase I: Determine the lowest effective dose of PTCy in combination with sirolimus and mycophenolate mofetil as GVHD prophylaxis after reduced intensity conditioning and PBSCT, as assessed by primary graft failure AND Grade III-IV acute GVHD as ..."],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als"],"drugSlugs":[],"locationSlugs":["duarte-california","bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Melphalan for Peripheral Blood Stem Cell Transplantation","inPlainEnglish":"Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments. A transplant of blood stem cells from a healthy donor can help people with these cancers.","whoItsFor":["Ages 12 Years to 120 Years","Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation limited to one of the following:","Acute myeloid leukemia (AML) of intermediate or adverse risk disease by the 2017 European LeukemiaNet criteria in first morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)","AML of any risk in second or subsequent morphologic complete remission","Acute lymphoblastic leukemia in first or subsequent complete remission","Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)","Primary myelofibrosis of intermediate-2 or higher risk by the DIPSS","Chronic myelomonocytic leukemia"],"whoShouldSkip":["Participants who are receiving any other investigational agents. Prior experimental therapies must have been completed at least 2 weeks prior to the date of beginning conditioning","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents","who can join:"],"whatHappens":"If you join, the listed intervention(s) are Melphalan, Sirolimus, or Total Body Irradiation (TBI). The registry lists allocation as na. Background: Blood cancers (such as leukemias or lymphomas) often do not respond to standard treatments.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 260 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.808Z"},{"nctId":"NCT05450432","title":"Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression","officialTitle":"Long-Term Maintenance With Ketamine and Esketamine for Reduction of Suicide in High-Risk Patients With Depression","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit. Eligible patients who provided informed consent will be enrolled in the study that will include a eight IV ketamine treatments, 13 esketamine treatment visits, seven long assessment visits, five short assessment visits, and daily surveys. The study will examine the feasibility, tolerability, and efficacy of repeated IV ketamine followed by esketamine, as well as predictors of treatment response.","conditions":["Major Depressive Disorder"],"keywords":["depression","suicidal ideation"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"DRUG","name":"Esketamine"}],"enrollment":100,"startDate":"2022-10-13","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Inpatient at a psychiatric unit (or MGH medical unit, awaiting transfer to psychiatry).\n2. Male and female, 18-70 years of age, inclusive, at screening.\n3. Diagnosis of MDD, single or recurrent, and currently experiencing a major depressive episode (MDE) at least eight weeks in duration, prior to screening, according to the criteria defined in the Diagnosis and Statistical manual of Mental Disorders, Fifth Edition (DSM-5). The diagnosis of MDD will be made by a site psychiatrist and supported by the Mini-International Neuropsychiatric Interview (MINI).\n4. Suicidal ideation determined by a minimum score of 1 on item 12 of the QIDS-C assessment and based on admission to the inpatient unit for suicidal thoughts or behaviors.\n5. In good general health, as ascertained by medical history. If needed to verify health status, the investigator may order/conduct physical examination (PE) (including measurement of supine and standing vital signs), clinical laboratory evaluations, or ECG.\n6. A status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:\n\n1\\. Non-childbearing potential (e.g., physiologically incapable of becoming pregnant, i.e., permanently sterilized (status post hysterectomy, bilateral tubal ligation), or is post-menopausal with her last menses at least one year prior to screening); or 2. Childbearing potential, and meets the following criteria:\n\n1. Childbearing potential, including women using any form of hormonal birth control, on hormone replacement therapy started prior to 12 months of amenorrhea, using an intrauterine device (IUD), having a monogamous relationship with a partner who has had a vasectomy, or is sexually abstinent.\n2. Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test prior to receiving study treatment.\n3. Willing and able to continuously use a method of birth control during the course of the study (implants, injectable or patch hormonal contraception, oral contraceptives, IUD, double-barrier contraception, sexual abstinence). The form of birth control will be documented at screening.\n\n7\\. Access to a mobile phone or computer with internet connection. 8. Ability to read, understand and provide written and dated informed consent prior to screening.\n\n9\\. Must have a provider to manage psychiatric medication, such as a psychiatrist, nurse practitioner, primary care physician, etc., either prior to admission or at discharge from the inpatient unit.\n\nExclusion Criteria:\n\n1. Any history of previous treatment with IV ketamine.\n2. Pregnant or breastfeeding.\n3. Subject of childbearing potential who is not willing to use birth control during the study.\n4. Unstable medical illness, i.e., severe liver or kidney disease, uncontrolled hypertension, uncontrolled hyperthyroidism\n5. Current diagnosis of a moderate to severe substance use disorder (excluding mild or moderate alcohol or cannabis use disorder which will be permitted), within the last six months prior to screening based on DSM-5 criteria.\n6. History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes.\n7. An Axis I or Axis II Disorder, which at screening is clinically predominant to their MDD or has been predominant to their MDD at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD).\n8. Currently receiving ECT treatment.\n9. Currently receiving frequent or high dose benzodiazepines, opiates, barbiturates, or other CNS depressant medications, based on an increased risk of sedation in combination with ketamine.\n10. Has dementia, delirium, amnestic, or any other primary cognitive disorder.\n11. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to a licensed physician on the study staff.\n12. Inability to consent to or comply with the study procedures.\n13. Other medical issues:\n\n    1. Hypertension, (SBP ≥160 mmHg or DBP ≥100 mHg) at Screening - untreated\n    2. Recent myocardial infarction (within one year)\n    3. Lifetime history of surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation, or any other disease/procedure/accident/intervention which, according to the screening done by a licensed physician, is deemed associated with significant injury to or malfunction of the CNS, or history of significant head trauma within the past 2 years\n    4. Thyroid stimulating hormone (TSH) outside of the normal limits and clinically significant as determined by the Investigator.\n    5. Any other clinically significant abnormal laboratory result (determined as such by the Investigator and/or medical monitor) at the time of the screening.\n    6. Patients with diabetes mellitus fulfilling any of the following criteria:\n\n1\\. Unstable diabetes mellitus defined as glycosylated hemoglobin (HbA1c) \\>8.5% at screening.\n\n2\\. Admitted to hospital for treatment of diabetes mellitus or diabetes mellitus- related illness in the past 12 weeks.\n\ng. Patients with a history of narrow angle glaucoma - untreated 14. Inability to comply with ketamine clinic safety procedures, including having reliable escorts to and from visits.","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cristina Cusin, MD","phone":"617-724-5510","email":"mghketamindstudy@partners.org"},{"name":"Catherine Schuessler, BS","phone":"617-643-7690","email":"mghketamindstudy@partners.org"}],"primaryOutcomes":["Feasibility - Retention","Feasibility - Drop-out Rates","Tolerability - Cognitive Function and Side Effects","Tolerability - Dosage of Treatment","Tolerability - Frequency of Treatment"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 4: testing Ketamine for Major Depressive Disorder","inPlainEnglish":"The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls. Patients will be recruited from an inpatient psychiatric unit.","whoItsFor":["Ages 18 Years to 70 Years","Inpatient at a psychiatric unit (or MGH medical unit, awaiting transfer to psychiatry)","Male and female, 18-70 years of age, inclusive, at screening","Suicidal ideation determined by a minimum score of 1 on item 12 of the QIDS-C assessment and based on admission to the inpatient unit for suicidal thoughts or behaviors","In good general health, as ascertained by medical history. If needed to verify health status, the investigator may order/conduct physical examination (PE) (including measurement of supine and standing vital signs), clinical laboratory evaluations, or ECG","A status of non-childbearing potential or use of an acceptable form of birth control per the following specific criteria:","Negative urinary pregnancy test at screening, confirmed by a negative urinary pregnancy test prior to receiving study treatment","9\\. Must have a provider to manage psychiatric medication, such as a psychiatrist, nurse practitioner, primary care physician, etc., either prior to admission or at discharge from the inpatient unit"],"whoShouldSkip":["Any history of previous treatment with IV ketamine","Pregnant or breastfeeding","Subject of childbearing potential who is not willing to use birth control during the study","Unstable medical illness, i.e., severe liver or kidney disease, uncontrolled hypertension, uncontrolled hyperthyroidism","Current diagnosis of a moderate to severe substance use disorder (excluding mild or moderate alcohol or cannabis use disorder which will be permitted), within the last six months prior to screening based on DSM-5 criteria","History of bipolar disorder, or any psychotic symptoms in the current or previous depressive episodes","An Axis I or Axis II Disorder, which at screening is clinically predominant to their major depression or has been predominant to their major depression at any time within six months prior to screening (i.e., eating disorder, OCD, PTSD)"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Esketamine. The registry lists allocation as na. The study will consist of a 24-week-long trial examining outcomes in patients with Major Depressive Disorder and suicidal ideation who will receive intravenous (IV) ketamine and intranasal (IN) esketamine, compared to a large sample of matched historical controls.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.101Z"},{"nctId":"NCT05470491","title":"Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...","officialTitle":"A Phase I/II Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nPeople living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.\n\nObjective:\n\nThis study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.\n\nEligibility:\n\nPeople aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.\n\nDesign:\n\nThe study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.\n\nParticipants will be screened. Their diagnoses, organ function and eligibility will be confirmed.\n\nParticipants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.\n\nParticipants will be in the hospital for 6 weeks or longer.\n\nThey will receive various drugs for 2 weeks to prep their body for the transplant.\n\nThe transplant cells will be administered through the catheter.\n\nParticipants will continue to receive drug treatments after the transplant.\n\nBlood transfusions may also be needed.\n\nParticipants will return 1-2 times per week for follow-up visits for 3 months after discharge.\n\nParticipants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.","conditions":["HIV","Hematologic Malignancies"],"keywords":["Hematopoietic Cell Transplant","HCT","Human Immunodeficiency Virus"],"interventions":[{"type":"DRUG","name":"RIC"},{"type":"DRUG","name":"GVHD prophylaxis"},{"type":"PROCEDURE","name":"allo HCT"},{"type":"DRUG","name":"Plerixafor"},{"type":"DRUG","name":"Maraviroc"}],"enrollment":265,"startDate":"2023-01-26","completionDate":"2027-07-30","sex":"ALL","minAge":"12 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA - RECIPIENT:\n* Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:\n\n  * Acute myeloid leukemia in morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)\n  * Any secondary and/or treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy/radiation\n  * B-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * T-cell acute lymphoblastic leukemia in first or subsequent complete remission\n  * Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)\n  * Primary myelofibrosis of intermediate-2 or higher risk by the Dynamic IPSS-Plus (DIPSS-Plus) or high to very high risk score (5 or higher) calculated with MIPSS70+ Calculator; DIPSS-Plus For Myeloproliferative Neoplasms on the Mutation Enhanced International Prognostic Score System (MIPSS70/MIPSS70+)\n  * Chronic myelomonocytic leukemia\n  * Chronic myelogenous leukemia resistant to or intolerant of \\>=3 tyrosine kinase inhibitors or with history of accelerated phase or blast crisis\n  * B-cell lymphoma including Hodgkin lymphoma that has relapsed/progressed within 1 year of completion of primary treatment, after autologous transplantation or has progressed through at least 2 lines of therapy\n  * Burkitt or lymphoblastic lymphoma: high-risk disease in first remission, progression/relapse after \\>=1 previous regimen\n  * Chronic lymphocytic leukemia with 17p deletion and/or unmutated IgHv or refractory or intolerant of both BTK and PI3K inhibitors\n  * Mature T or NK neoplasms as defined in the WHO guidelines of sufficient type and severity for allogeneic HCT based on published clinical practice guidelines\n  * T-Prolymphocytic leukemia progressing/relapsing after alemtuzumab and at least one other regimen\n  * B-Prolymphocytic leukemia progressing/relapsing after fludarabine and at least one other salvage regimen\n  * Hematologic malignancy of dendritic cell or histiocytic cell type\n  * Multiple myeloma that relapses after therapy with both a proteasome inhibitor and an immunomodulatory drug (IMiD), relapses after autologous transplantation, or manifests as plasma cell leukemia\n\nIn addition to standard indications for HCT: Participant with a hematologic malignancy eligible for consolidation of first remission with autologous transplantation, if autologous transplantation is not accessible to the participant.\n\n* HIV seropositive, with ART regimen that, when stable for \\>4 weeks, is associated with an HIV viral load \\<400 copies/mL at screening evaluations. Subsequent changes to avoid/optimize drug interactions with study drugs or essential supportive care drugs may be made to the ART regimen at any time during the eligibility assessment period, as long as the eligibility criteria were met and the regimen change is expected, by the study team and involved consultants/pharmacy, to be similarly effective for HIV control. These changes to the ART regimen are not part of the study. If changes to the ART regimen are made during the eligibility period, HIV viral load will be rechecked at least 1 week after the change but prior to protocol treatment consent.\n\n  * Dose level 1: ART regimen must include maraviroc\n  * Dose level 2 and 3: ART regimen must not include maraviroc and there must be no history of maraviroc intolerance or resistance\n* Age \\>= 18 years\n* At least one potentially suitable HLA-haploidentical first degree or collateral related donor. Recipients with donor-specific anti-HLA antibodies (DSAs) to all potential donors must have at least one potential donor option where the DSA strength has a mean fluorescence intensity of \\< 5000 and antibodies are not complement-fixing.\n* Karnofsky performance score \\>=50 percent.\n* Adequate organ function defined as possessing all of the following:\n\n  * Cardiac ejection fraction by 2D ECHO of \\>=40 percent\n  * Forced expiratory volume-1 (FEV-1), forced vital capacity (FVC), and diffusing capacity of the lung for carbon monoxide (DLco, adjusted for hemoglobin) all of \\>=40 percent predicted. If unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation \\>92 percent on room air.\n  * Total bilirubin \\<=3.0 mg/dL (unless due to Gilbert's or hemolysis), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \\<= 5x the upper limit of normal, gamma glutamyl transferase (GGT) \\<= 5x the upper limit of normal\n* Estimated serum creatinine clearance of \\>=50 mL/min/1.73m2 calculated using eGFR in the clinical lab\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n* Individuals of childbearing potential and those that can father children must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for at least one-year post-allo HCT.\n\nEXCLUSION CRITERIA - RECIPIENT:\n\n* Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning conditioning.\n* Poorly controlled malignant indication for transplantation, defined as:\n\n  * Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5 percent or active extramedullary disease)\n  * Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and/or radiologic assessment\n  * Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \\<= 5 percent plasma cells in the bone marrow.\n* Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation.\n* Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \\<400 copies/mL that is compatible with study drugs\n* Pregnancy\n* For lactating potential participants: unwilling to discontinue lactation prior to the start of study treatment on day -14.\n* Prohibitive allergy to a study drug or to compounds of similar chemical or biologic composition of the agents (eATG, steroids, cyclophosphamide, busulfan, pentostatin, maraviroc, bortezomib, plerixafor (dose level 3 only)) used in the study.\n* Lack of central access potential sufficient for transplant\n* Active psychiatric disorder which is deemed by the PI to have significant risk of compromising compliance with the transplant protocol and/or antiretroviral therapy\n* Grade 3-4 motor or sensory neuropathy per CTCAE version 5.0\n\nINCLUSION CRITERIA - RELATED DONOR:\n\n* Related donor (age \\>=12) deemed suitable and eligible, and willing to donate, per clinical evaluations, who are additionally willing to donate blood and/or PBSC graft aliquotfor research. Related donors will be evaluated in accordance with existing institutional Standard Policies and Procedures for determination of eligibility and suitability for clinical donation.\n* Ability of participant or parent/legal guardian to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA - RELATED DONOR:\n\n-Failure to qualify per institutional Standard Policies","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessenia C Campos, R.N.","phone":"(301) 402-0300","email":"jessenia.campos@nih.gov"},{"name":"Mustafa A Hyder, M.D.","phone":"(240) 858-3182","email":"mustafa.hyder@nih.gov"}],"primaryOutcomes":["In phase II, avoidance rate of grade III-IV acute GVHD at day +100","Determine a safe and recommended phase II dose level regimen"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing RIC for HIV","inPlainEnglish":"Background: People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.","whoItsFor":["Ages 12 Years to 120 Years","Participants must have a histologically or cytologically confirmed hematologic malignancy with standard indication for allogeneic hematopoietic cell transplantation including, but not limited to, one of the following:","Acute myeloid leukemia in morphologic complete remission (\\<5% blasts in the bone marrow, no detectable abnormal peripheral blasts, and no extramedullary disease)","Any secondary and/or treatment related myeloid neoplasm with antecedent history of myeloid neoplasm or previous chemotherapy/radiation","B-cell acute lymphoblastic leukemia in first or subsequent complete remission","T-cell acute lymphoblastic leukemia in first or subsequent complete remission","Myelodysplastic syndrome of intermediate or higher score by the Revised International Prognostic Scoring System (IPSS-R)","Chronic myelomonocytic leukemia"],"whoShouldSkip":["Participants who are receiving any other investigational agents that cannot be discontinued/completed at least 2 weeks prior to the date of beginning conditioning","Poorly controlled malignant indication for transplantation, defined as:","Leukemia not having achieved morphologic remission (i.e. bone marrow blasts \\>5 percent or active extramedullary disease)","Lymphoma not having demonstrated some degree of treatment sensitivity (chemosensitivity, radiosensitivity) by clinical and/or radiologic assessment","Multiple myeloma not in complete remission, as determined by negative immunofixation in serum and urine and disappearance of any soft tissue plasmacytomas and \\<= 5 percent plasma cells in the bone marrow","Uncontrolled intercurrent illness that in the opinion of the PI would make it unsafe to proceed with transplantation","Study team is unable to identify an adequate antiretroviral regimen to adequately suppress the HIV viral load \\<400 copies/mL that is compatible with study drugs"],"whatHappens":"If you join, the listed intervention(s) are RIC, GVHD prophylaxis, or allo HCT. The registry lists allocation as randomized. Background: People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 265 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.527Z"},{"nctId":"NCT05472441","title":"Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)","officialTitle":"Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"SINGLE","sponsor":"Ohio State University","sponsorClass":"OTHER","summary":"This is a pragmatic randomized controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.","conditions":["Diabetes Mellitus, Type 2","Nutrition Poor","Food Deprivation"],"keywords":["Food Insecurity","Social Determinants of Health","Non-medical, health related social needs","Diabetes Self-Management Education and Support"],"interventions":[{"type":"BEHAVIORAL","name":"Mid-Ohio Food Farmacy"},{"type":"BEHAVIORAL","name":"Mid-Ohio Food Farmacy + Cooking for Diabetes"},{"type":"BEHAVIORAL","name":"Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub"},{"type":"BEHAVIORAL","name":"Mid-Ohio Food Farmacy + Cooking for Diabetes + Health Impact Ohio Pathways Hub"}],"enrollment":568,"startDate":"2023-02-06","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Type 2 Diabetes based on American Diabetes Association Criteria\n* Hemoglobin A1c ≥ 7.5%\n* Screen Positive on 2-item Food Security Screener\n\nExclusion Criteria:\n\n* Unwilling to Attest to Release of Information to Mid-Ohio Food Collective","locations":[{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luiza Reopell, BS","phone":"614-653-8213","email":"luiza.reopell@osumc.edu"},{"name":"Daniel Walker, PhD","phone":"614-293-2428","email":"Daniel.Walker@osumc.edu"}],"primaryOutcomes":["Change in Hemoglobin A1c"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Mid-Ohio Food Farmacy for Diabetes Mellitus, Type 2","inPlainEnglish":"This is a pragmatic randomly assigned controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.","whoItsFor":["Ages 18 Years to any","Type 2 Diabetes based on American Diabetes Association Criteria","Hemoglobin A1c ≥ 7.5%","Screen Positive on 2-item Food Security Screener"],"whoShouldSkip":["Unwilling to Attest to Release of Information to Mid-Ohio Food Collective"],"whatHappens":"If you join, the listed intervention(s) are Mid-Ohio Food Farmacy, Mid-Ohio Food Farmacy + Cooking for Diabetes, or Mid-Ohio Food Farmacy + Health Impact Ohio Pathways Hub. The registry lists allocation as randomized. This is a pragmatic randomly assigned controlled trial (pRCT) that aims to test the effect of produce provision, diabetes education, and community referrals on hemoglobin A1c levels in individuals with type 2 diabetes experiencing food insecurity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 568 people at Columbus. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.526Z"},{"nctId":"NCT05492682","title":"START: Safety and Anti-Tumor Activity of PeptiCRAd-1 in Treatment of Cancer","officialTitle":"A Study to Evaluate the Safety and Immune Activity of PeptiCRAd-1 in Combination With Pembrolizumab in Patients With Injectable Solid Tumors in Indications Known to Express NY-ESO-1 and MAGE-A3","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Valo Therapeutics Oy","sponsorClass":"INDUSTRY","summary":"This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.","conditions":["Melanoma (Skin)","Triple-Negative Breast Cancer","Non-Small Cell Lung Cancer","Synovial Sarcoma","Myxoid Liposarcoma","Colorectal Cancer","Osteosarcoma","Sarcoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"PeptiCRAd-1"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":15,"startDate":"2023-02-02","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written informed consent.\n2. Male or female, ≥18 years of age.\n3. Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy:\n\n   * Inoperable/metastatic cutaneous malignant melanoma\n   * Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC\n   * Inoperable advanced/metastatic non-squamous NSCLC\n   * Inoperable and/or advanced Synovial or myxoid round cell sarcoma\n   * Inoperable and/or advanced osteosarcoma\n   * Inoperable and/or advanced colorectal cancer, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n   * Inoperable and/or advanced/metastatic sarcoma, patients assessed as positive for NY-ESO-1 or MAGE-A3 expression at baseline\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n5. Tumor lesion which is deemed feasible for biopsy and injection\n6. ECOG/WHO performance status 0 to 1.\n7. Acceptable liver and renal function, defined as:\n\n   * Total bilirubin ≤1.5 x upper limit of normal (ULN; does not include patients with Gilbert's Disease), and\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x ULN, and\n   * Serum creatinine ≤1.5 x ULN\n8. Acceptable hematological function, defined as:\n\n   * Hemoglobin ≥9 g/dL, and\n   * Neutrophils ≥1.5 x 109/L, and\n   * Platelet count ≥100 x 109/L Patients may be transfused to meet the hemoglobin entry criteria.\n9. Acceptable coagulation status defined by international normalized ratio (INR) of blood clotting, prothrombin time and activated partial thromboplastin time within ≤1.5 x upper limit of normal.\n10. Negative pregnancy test at screening in all women of childbearing potential (WOCBP). Such patients must agree to use a highly effective method of contraception (Appendix 1) during study intervention and for 3 months after the last virus treatment, 4 months after the last dose of pembrolizumab, and 12 months after CPO dosing. Male patients and male partners of female patients must also use barrier contraception, i.e., condom, for the time periods specified for WOCBP, plus a further 3 month period.\n\n    Urine pregnancy tests should have a sensitivity of at least 25 mIU/mL for human chorionic gonadotropin (hCG). If the urine test is positive, it must be followed by a quantitative analysis of hCG concentration in blood.\n11. Prior therapy with an immune CPI is allowed provided a 6-week washout period is observed for patients with prior programmed cell death (PD)1 or PDL1 treatment\n\nExclusion Criteria:\n\n1. Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1.\n2. Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \\>10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed.\n3. Prior or concomitant radiotherapy within 4 weeks before Day 1.\n4. Participation in a study with an investigational drug or device within 4 weeks prior to Day 1.\n5. Active bacterial, viral, or fungal infection that requires systemic therapy.\n6. Active autoimmune disease that has required systemic treatment in the past two years.\n7. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study.\n8. Any concomitant medical condition requiring receipt of a therapeutic anticoagulant that, in the opinion of the treating physician, cannot safely be withheld to allow for repeated injection of PeptiCRAd 1 and tumor biopsies.\n9. Known infection with human immunodeficiency virus, hepatitis B, or hepatitis C or active tuberculosis.\n10. Known active central nervous system metastases. Patients with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage are excluded.\n\n    Note: Participants with asymptomatic brain metastases (i.e. off corticosteroids and anticonvulsants for at least 7 days) are permitted.\n11. Any prior severe AE according to Common Terminology Criteria for Adverse Events (CTCAE), severe hypersensitivity reaction attributed to prior anti-PD1 or PDL1 therapy or components of the study intervention or has a history of any contraindication that, in the investigator's opinion, would contraindicate pembrolizumab administration such as:\n\n    * Resolution of side effect of prior anti-PD1 or PDL1 therapy to Grade 1\n    * Grade 2 or higher pneumonitis\n    * Grade 4 AST or ALT elevation\n    * Grade 3 or higher colitis attributable to immunotherapy Note: in the absence of clinical symptoms of pancreatitis, elevations of amylase or lipase are not contraindications to therapy on this trial.\n12. History of or planned tissue / organ transplant.\n13. Females who are pregnant or breast feeding or expecting to conceive within the projected duration of the study starting with the screening visit or males expecting to father children within the projected duration of the study starting with the screening visit.\n14. Unwillingness or inability to comply with the study protocol for any reason.\n15. Admission to an institution by virtue of an order issued by the judicial or administrative authorities.\n16. Sponsor or Contract Research Organization employees, or employees under the direct supervision of the investigator or the investigational sites and/or involved directly in the study.\n17. Prior or concurrent malignancy, unless the natural history or treatment of the disease does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.","locations":[{"facility":"Krankenhaus Nordwest","city":"Frankfurt","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Center for Tumor Diseases","city":"Heidelberg","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS","city":"Candiolo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Clinico Humanitas","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Università di Napoli Federico II","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kuryk, PhD","phone":"0505876088","email":"info@valotx.com"}],"primaryOutcomes":["Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 monotherapy.","Measurement of Safety and tolerability indexes (Incidence of TEAEs, SAEs and DLTs as assessed by CTCAE version 5.0 and changes in assessed safety parameters) for PeptiCRAd-1 and CPI combination."],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","melanoma"],"drugSlugs":["pembrolizumab"],"locationSlugs":["frankfurt-germany","heidelberg-germany","t-bingen-germany","candiolo-italy","milan-italy","naples-italy"],"enrichment":{"headline":"Phase 1: testing PeptiCRAd-1 for Melanoma (Skin)","inPlainEnglish":"This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.","whoItsFor":["Ages 18 Years to any","Male or female, ≥18 years of age","Patients with any 1 of the following histologically confirmed tumors and who qualifies for new or continued CPI therapy and relapsing to/after standard therapy or the patient has refused or does not tolerate standard therapy:","Inoperable/metastatic cutaneous malignant melanoma","Relapsed or newly diagnosed locally advanced inoperable/metastatic TNBC","Inoperable advanced/metastatic non-squamous NSCLC","Inoperable and/or advanced Synovial or myxoid round cell sarcoma","Inoperable and/or advanced osteosarcoma"],"whoShouldSkip":["Receipt of any oncolytic virus treatment, or administration of a vaccine containing live virus within 4 weeks before Day 1","Use of significant immunosuppressive medication, including high dose corticosteroid (defined as the equivalent of \\>10 mg/day prednisone) within 4 weeks before Day 1. Inhaled or topical corticosteroid use is allowed","Prior or concomitant radiotherapy within 4 weeks before Day 1","Participation in a study with an investigational drug or device within 4 weeks prior to Day 1","Active bacterial, viral, or fungal infection that requires systemic therapy","Active autoimmune disease that has required systemic treatment in the past two years","Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient, if included in this study"],"whatHappens":"If you join, the listed intervention(s) are PeptiCRAd-1, Cyclophosphamide, or Pembrolizumab. The registry lists allocation as randomized. This study is being conducted to explore the immunological mechanism of action of Peptide-coated Conditionally Replicating Adenovirus-1 (PeptiCRAd-1) plus Checkpoint inhibitor (CPI) therapy in multiple cancer types, as well as to obtain early information on the safety of this combination therapy.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.966Z"},{"nctId":"NCT05498428","title":"A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer","officialTitle":"A Phase 2, Open-Label, Parallel Cohort Study of Subcutaneous Amivantamab in Multiple Regimens in Patients With Advanced or Metastatic Solid Tumors Including EGFR-mutated Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \\[SC-CF\\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).","conditions":["Carcinoma, Non-small-Cell Lung"],"keywords":[],"interventions":[{"type":"DRUG","name":"Amivantamab"},{"type":"DRUG","name":"Lazertinib"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Direct Oral Anticoagulant (DOAC)"},{"type":"DRUG","name":"Low Molecular Weight Heparin (LMWH)"}],"enrollment":520,"startDate":"2022-11-11","completionDate":"2027-08-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-small cell lung cancer (NSCLC) that is not amenable to curative therapy including surgical resection or chemoradiation. Additional Cohort specific disease requirements include: Cohorts 1, 3, 3b, 5, 6 and 7: epidermal growth factor receptor (EGFR) exon 19 deletion (Exon19del) or Exon 21 L858R mutation; Cohort 2: EGFR Exon 20ins mutation. Cohorts 1,5,and6: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohort 2: Participant should not have received any prior systemic therapy for locally advanced or metastatic NSCLC. Cohorts 3and3b: Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Cohort 4: Participants need to currently be on an amivantamab IV Q2W regimen (1,050 mg or 1,400 mg depending on weight) for at least 8 weeks, as part of standard of care, an expanded access program, or as a rollover from a long-term extension, without any amivantamab dose reduction. Cohort 7: Participants must have progressed on or after the combination of amivantamab and lazertinib as the most recent line of treatment. The combination of amivantamab and lazertinib must have been administered as the first-line treatment for locally advanced or metastatic disease. Cohort 2, 3, 3b, and 7 only: Squamous NSCLC are excluded. EGFR mutation must have been identified as determined by Food and Drug Administration (FDA) approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United states \\[US\\]) or an accredited local laboratory (sites outside of the US). A copy of the initial test report documenting the EGFR mutation must be included in the participant records and a deidentified copy must also be submitted to the sponsor\n* All cohorts except Cohort 4: Participants must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If the only target lesion has been previously irradiated, it must show signs of disease progression since radiation was completed If only 1 non-irradiated measurable lesion exists, which undergoes a biopsy and is acceptable as a target lesion, the baseline tumor assessment scans should be performed at least 14 days after the biopsy\n* May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s)\n* Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions\n* Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1\n* Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment\n* A participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for a period of 6 months after receiving the last dose of study treatment. Participants with child bearing potential should consider preservation of eggs prior to study treatment as anti-cancer treatments may impair fertility\n\nExclusion Criteria:\n\n* Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis\n* Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort\n* Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary\n* For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1\n* Other clinically active liver disease of infectious origin\n* Participant has a history of clinically significant cardiovascular disease including, but not limited to: a) All cohorts: diagnosis of deep vein thrombosis or pulmonary embolism within 1 month prior to the first dose of study treatment(s), or any of the following within 6 months prior to the first dose of study treatment(s): myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary/peripheral artery bypass graft, or any acute coronary syndrome. Clinically non-significant thrombosis, such as non-obstructive catheter-associated clots, are not exclusionary; b) All cohorts (with regimens potentially including lazertinib): Participant has a significant genetic predisposition to venous thromboembolic events (VTE; such as Factor V Leiden); c) All cohorts (with regimens potentially including lazertinib): Participant has a prior history of VTE and is not on appropriate therapeutic anticoagulation as per NCCN or local guidelines; d) prolonged corrected QT interval by Fridericia (QTcF) interval greater than (\\>) 480 milliseconds (msec) or clinically significant cardiac arrhythmia or electrophysiologic disease (example, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate); e) uncontrolled (persistent) hypertension: systolic blood pressure \\>160 millimeter(s) of mercury (mmHg); diastolic blood pressure \\>100 mmHg; f) Congestive heart failure defined as NYHA class III-IV or hospitalization for congestive heart failure (CHF) (any New York Heart Association \\[NYHA\\] class) within 6 months of treatment initiation at Cycle 1/day 1 (C1D1); g) pericarditis/clinically significant pericardial effusion; h) myocarditis; i) baseline left ventricular ejection fraction (LVEF) below the institution's lower limit of normal at screening, as assessed by echocardiogram or multigated acquisition (MUGA) scan\n* Participant has symptomatic brain metastases. A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants who have received definitive radiation or surgical treatment for symptomatic or unstable brain metastases and have been clinically stable and asymptomatic for at least 2 weeks before Screening are eligible, provided they have been either off corticosteroid treatment or are receiving low-dose corticosteroid treatment (less than or equal to \\[\\<=\\] 10 milligrams per day \\[mg/day\\] prednisone or equivalent) for at least 2 weeks prior to treatment allocation","locations":[{"facility":"University of California at San Diego","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Lynn Cancer Institute","city":"Boca Raton","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. 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Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cheltenham General Hospital","city":"Cheltenham","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Torbay Hospital-Devon","city":"Devon","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edinburgh Cancer Centre Western General","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nottingham City Hospital","city":"Nottingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Alexandra Hospital","city":"Portsmouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["All Cohorts Except Cohort 4: Objective Response Rate (ORR) Based on Investigator Assessment (INV)","Cohort 4: Number of Participants with Adverse Events (AEs)","Cohort 4: Number of Participants with AEs by Severity","Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values","Cohort 4: Number of Participants with Abnormalities in Clinical Laboratory Values by Severity"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["la-jolla-california","orange-california","stanford-california","washington-d-c-district-of-columbia","boca-raton-florida","miami-beach-florida","orlando-florida","tampa-florida","westwood-kansas","baltimore-maryland","boston-massachusetts","st-louis-missouri","hackensack-new-jersey","new-brunswick-new-jersey","east-syracuse-new-york","charlotte-north-carolina","winston-salem-north-carolina","cleveland-ohio","mayfield-heights-ohio","warrensville-heights-ohio","salt-lake-city-utah","fairfax-virginia","everett-washington","seattle-washington","barretos-brazil","belo-horizonte-brazil","londrina-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","salvador-brazil","s-o-paulo-brazil","baoding-china","changchun-china","chengdu-china","chongqing-china","guangzhou-china","hangzhou-china","harbin-china","huizhou-china","liuzhou-china","shanghai-china","tianjin-china","wenzhou-china","wuhan-china","wuxi-china","xian-china","yantai-china","caen-france","dijon-france","n-mes-france","paris-france","saint-herblain-france","villejuif-france","berlin-germany","cologne-germany","grosshandorf-germany","immenhausen-germany","w-rzburg-germany","haifa-israel","jerusalem-israel","kfar-saba-israel","petah-tikva-israel","ramat-gan-israel","genova-italy","milan-italy","monza-italy","naples-italy","himeji-japan","matsusaka-japan","niigata-japan","shizuoka-japan","tokyo-japan","wakayama-japan","kuala-lumpur-malaysia","kuantan-malaysia","kuching-malaysia","petaling-jaya-malaysia","goyang-si-south-korea","seongnam-si-south-korea","seoul-south-korea","a-coru-a-spain","alicante-spain","barcelona-spain","madrid-spain","m-laga-spain","seville-spain","valencia-spain","cheltenham-united-kingdom","devon-united-kingdom","edinburgh-united-kingdom","leicester-united-kingdom","london-united-kingdom","nottingham-united-kingdom","portsmouth-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Amivantamab for Carcinoma, Non-small-Cell Lung","inPlainEnglish":"This study wants to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \\[SC-CF\\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).","whoItsFor":["Ages 18 Years to any","May have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the how well it works of the study treatment(s)","Have adequate organ (renal, hepatic, hematological, coagulation and cardiac) functions","Participant must have eastern cooperative oncology group (ECOG) status of 0 or 1","Cohort 6: Must be eligible for, and agree to comply with, the use of prophylactic anticoagulation with a direct oral anticoagulant or a low molecular weight heparin during the first 4 months of study treatment"],"whoShouldSkip":["Participant has a medical history of interstitial lung disease (ILD), including drug induced ILD or radiation pneumonitis","Participant has a history of hypersensitivity to any excipients of the investigational products to be used in their enrollment cohort","Participant has received a live or live attenuated vaccine within 3 months before Cycle 1 Day 1. The seasonal influenza vaccine and non-live vaccines against Coronavirus disease 19 (COVID-19) are not exclusionary","For all cohorts (with regimens potentially including lazertinib): Participant is currently receiving medications or herbal supplements known to be potent Cytochrome (CYP3A4/5) inducers and is unable to stop use for an appropriate washout period prior to Cycle 1 Day 1","Other clinically active liver disease of infectious origin"],"whatHappens":"If you join, the listed intervention(s) are Amivantamab, Lazertinib, or Carboplatin. The registry lists allocation as randomized. This study wants to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \\[SC-CF\\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 520 people at 110 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.675Z"},{"nctId":"NCT05500001","title":"Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study","officialTitle":"Supporting Patients by Family Education in Psychotic Illness: A Prospective Cohort Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level. By equipping families with skills and knowledge, public healthcare harnesses a powerful ally to maintain community stabilization.\n\nAims: The primary study goal is to implement a psychoeducation intervention for family carers supporting young adults with psychosis to reduce family burden and foster community stabilization of service users.\n\nMethods: A longitudinal pre-post design will be used to assess the long-term effectiveness of the psychoeducation intervention for family carers supporting a young adult with psychosis on service utilization and functional indexes. Nine expert-reviewed, and family peer-informed psychoeducation modules are administered in 2-hour sessions over 9 weeks to family carers.\n\nConclusion: Presenting the novel approach of an expert-reviewed, peer-informed psychoeducation intervention for family carers, with a focus on knowledge and skill development, the researchers contribute to literature and best practice in patient and family-centered care.","conditions":["Psychotic Disorders","Family Members","Anosognosia","Paranoia"],"keywords":["Young Adult","Psychosis","Family Psychoeducation","Family Burden","Acceptance and Commitment Therapy","LEAP"],"interventions":[{"type":"BEHAVIORAL","name":"Supporting Patients by Family Education in Psychotic Illness Group"}],"enrollment":113,"startDate":"2022-09-01","completionDate":"2028-12-01","sex":"ALL","minAge":"17 Years","maxAge":"27 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Young adult service user is aged 17-27 at time of recruitment\n* Young adult service user has had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months\n\nExclusion Criteria:\n\n* Not proficient in English\n* Young adult service user has NOT had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months","locations":[{"facility":"Royal Alexandra Hospital","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Hospital Edmonton","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta Hospital","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grey Nuns Community Hospital","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melanie Robles, MD","phone":"(780) 983-9773","email":"maduples@ualberta.ca"}],"primaryOutcomes":["Family Burden Interview Schedule","Family Burden Interview Schedule","Family Burden Interview Schedule","Family Burden Interview Schedule","Positive and Negative Symptom Schedule","Positive and Negative Symptom Schedule","Positive and Negative Symptom Schedule","Positive and Negative Symptom Schedule","Manchester Short Assessment of Quality of Life","Manchester Short Assessment of Quality of Life","Manchester Short Assessment of Quality of Life","Manchester Short Assessment of Quality of Life"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["edmonton-canada"],"enrichment":{"headline":"Not a traditional drug phase: Supporting Patients by Family Education in Psychotic Illness Group for Psychotic Disorders","inPlainEnglish":"Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one. Although family support groups exist, few groups offer evidence-based, skills-focused, psychoeducation taught by certified professionals and provided on a public-health level.","whoItsFor":["Ages 17 Years to 27 Years","Young adult service user is aged 17-27 at time of recruitment","Young adult service user has had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months"],"whoShouldSkip":["Not proficient in English","Young adult service user has NOT had an admission or discharge from an Alberta Health Services or Covenant Health psychiatric unit for psychosis in the Edmonton Zone within previous 12-months"],"whatHappens":"If you join, the listed intervention(s) are Supporting Patients by Family Education in Psychotic Illness Group. The registry lists allocation as na. Background: A lack of education, resources, and support for family carers of young adults with psychotic illnesses leaves them ill-equipped to support their loved one.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 113 people at 4 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.048Z"},{"nctId":"NCT05504694","title":"Ofatumumab in AQP4-IgG Seropositive NMOSD","officialTitle":"Efficacy and Safety of Ofatumumab in AQP4-IgG Seropositive NMOSD: an Open-label, Single-arm, Multicentre Prospective Pilot Study","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Tang-Du Hospital","sponsorClass":"OTHER","summary":"This is an open-label, single-arm, multicentre prospective pilot study to assess the efficacy and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.","conditions":["Neuromyelitis Optica Spectrum Disorder"],"keywords":["Neuromyelitis Optica Spectrum Disorder","Aquaporin 4","Ofatumumab"],"interventions":[{"type":"DRUG","name":"Ofatumumab"}],"enrollment":5,"startDate":"2022-06-28","completionDate":"2026-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG.\n* Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months.\n* Adults aged ≥18 years old.\n* Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive).\n* Provision of written informed consent to participate in this study.\n* Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month.\n* Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication.\n\nExclusion Criteria:\n\n* Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML.\n* Pregnant or breastfeeding patients and those with family planning during the study period.\n* Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening.\n* Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period.\n* Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression.\n* Active infection at within 4 weeks before baseline.\n* Positive for HBV or HCV.\n* Evidence of latent or active tuberculosis (TB).\n* Have received any live or live-attenuated vaccine within 6 weeks before baseline.\n* History of malignancy in past 5 years, including solid tumor, malignant hematopathy and carcinoma in situ.\n* History of severe allergic reactions to biological agents.\n* Inability to provide written informed consent.","locations":[{"facility":"Tangdu Hospital","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jun Guo, M.D.","phone":"86-29-8477 8844","email":"guojun_81@163.com"},{"name":"Yan Jia, M.S.","phone":"86-29-8471 7483","email":"neurologist_jiayan@163.com"}],"primaryOutcomes":["Change from baseline in annual relapse rate (ARR) at last follow-up visit"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["ofatumumab"],"locationSlugs":["xian-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Ofatumumab for Neuromyelitis Optica Spectrum Disorder","inPlainEnglish":"This is an open-label, single-arm, multicentre prospective pilot study to assess the how well it works and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.","whoItsFor":["Ages 18 Years to any","Diagnosis of NMOSD according to the 2015 International Panel Diagnostic Criteria for NMOSD with AQP4-IgG","Clinical evidence of at least 2 relapses (including first attack) in past 24 months with at least 1 relapse occurring in the preceding 12 months","Adults aged ≥18 years old","Expanded disability status scale (EDSS) score between 0 and 7.5 (inclusive)","Only oral corticosteroids were permitted at screening (≤10mg equivalent per day), which should be terminated within one month","Effective contraception was used for female patients with fertility during the treatment or at least 3 months after stopping medication"],"whoShouldSkip":["Progressive neurological deterioration unrelated to relapses of NMOSD, or presence of neurological findings suspected with PML","Pregnant or breastfeeding patients and those with family planning during the study period","Patients participating in any other clinical therapeutic study at the screening or within 30 days of screening","Patients with splenectomy or history of no spleen, and those with planned surgery (excluding minor surgery) during the study period","Presence of uncontrolled severe concurrent diseases; long-term glucocorticoids or immunosuppressants use due to other autoimmune diseases, or presence of other chronic diseases that cannot receiving immunosuppression","Active infection at within 4 weeks before baseline","Positive for HBV or HCV"],"whatHappens":"If you join, the listed intervention(s) are Ofatumumab. The registry lists allocation as na. This is an open-label, single-arm, multicentre prospective pilot study to assess the how well it works and safety of ofatumumab in patients with AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) in China.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 5 people at Xi'an. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.276Z"},{"nctId":"NCT05519475","title":"A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of siRNA Gene Silencing for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Participants With Genetic Risk Factors","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an investigational drug, ALN-HSD called \"study drug\". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH). MASH is a form of Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD). MASH occurs when fat builds up in liver cells, damaging them, and making the liver inflamed and stiff from fibrosis (scar tissue). MASH can progress to cirrhosis (long term scarring) and liver failure (when the liver cannot perform its job). The aim of the study is to see the effect of the study drug on lessening liver scarring related to MASH.\n\nThe study is looking at several other research questions, including:\n\n* How ALN-HSD works to improve liver function and lessen MASH-related inflammation in the liver\n* What side effects may happen from receiving the study drug\n* How much study drug and study drug metabolites (byproduct of the body breaking down the study drug) are in the blood at different times\n* Better understanding of the study drug and MASH","conditions":["Metabolic Dysfunction-Associated SteatoHepatitis (MASH)"],"keywords":["Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)","Histologically confirmed MASH","Genetic risk alleles for MASH at the HSD17B13 locus","Non-Alcoholic SteatoHepatitis (NASH)"],"interventions":[{"type":"DRUG","name":"ALN-HSD"},{"type":"DRUG","name":"Placebo"}],"enrollment":120,"startDate":"2023-02-09","completionDate":"2028-04-27","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Adult male or female ≥18 years (or country's legal age of adulthood)\n2. A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN\n3. NAS score ≥3, as defined in the protocol\n4. Meets genotype criteria for study enrollment, as defined in the protocol\n5. Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening\n\nKey Exclusion Criteria:\n\n1. Evidence of other forms of known chronic liver disease, as defined in the protocol\n2. Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol\n3. History of Type 1 diabetes\n4. Bariatric surgery within approximately 5 years prior to or planned during the study period\n5. Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)\n\nNote: Other protocol-defined Inclusion/Exclusion Criteria apply","locations":[{"facility":"The Institute for Liver Health II LLC DBA Arizona Clinical Trials - Flagstaff","city":"Flagstaff","state":"Arizona","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"The Institute for Liver Health II LLC DBA Arizona Liver Health - Peoria","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adobe Clinical Research","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II LLC dba Arizona Liver Health","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Fernando Valley Health Institute","city":"Canoga Park","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research","city":"Chula Vista","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research","city":"Gardena","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Huntington Park","city":"Huntington Park","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Om Research Llc","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research - Long Beach","city":"Long Beach","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Ark Clinical Research, LLC","city":"Long Beach","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Westlake","city":"Los Angeles","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Clinnova Research Solutions","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knowledge Research Center, St. Joseph's Medical Tower","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Research Institute","city":"Panorama City","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"California Liver Research Institute","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cadena Care Inst.","city":"Poway","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Inland Empire Clinical Trials","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precision Research Institute - San Diego","city":"San Diego","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare LLC","city":"Bradenton","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Evolution Clinical Trials","city":"Hialeah Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Awareness, inc.","city":"Jupiter","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Clinical Research","city":"Miami","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"International Medical Investigational Centers (IMIC) Incorporated","city":"Miami","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Genoma Research Group, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"US Associates in Research, LLC","city":"Miami","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Med Research of Florida, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research LLC - Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deaconess Clinic - GI Specialty Center","city":"Newburgh","state":"Indiana","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"GI Associates","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Geisinger Medical Center","city":"Danville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Health Milton S. Hershey Medical Center","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania - Perelman Center for Advanced Medicine","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Research, LLC","city":"Austin","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"American Research Corporation","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pinnacle Clinical Research - Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Research Institute (STRI) - Brownsville","city":"Brownsville","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Austin","city":"Cedar Park","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Methodist Dallas Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Research Institute (STRI) - Edinburg","city":"Edinburg","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"GI Alliance Research","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allure Health at Mt. Olympus Medical Research","city":"Friendswood","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Advanced Medical Trials","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pioneer Research Solutions, Inc.","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"R & H Clinical Research, Inc.","city":"Katy","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Great Lakes Research Institute","city":"Pharr","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"American Research Corporation at The Texas Liver Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pinnacle Clinical Research - San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"R & H Clinical Research","city":"Stafford","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Intermountain Health","city":"Murray","state":"Utah","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Virginia Medical Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond Veterans Administration Medical Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JCHO Hokkaido Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"TERMINATED","lat":null,"lon":null},{"facility":"Isis Clinical Research Center","city":"Guaynabo","state":"San Juan","country":"Puerto Rico","status":"TERMINATED","lat":null,"lon":null},{"facility":"Klinical Investigations","city":"San Juan","state":"","country":"Puerto Rico","status":"TERMINATED","lat":null,"lon":null},{"facility":"Latin Clinical Trial Center","city":"San Juan","state":"","country":"Puerto Rico","status":"TERMINATED","lat":null,"lon":null},{"facility":"Fundacion de Investigacion (FDI) Clinical Research","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Pusan National University Hospital","city":"Busan","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Kyungpook National University Hospital","city":"Daegu","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Hanyang University Seoul Hospital","city":"Seoul","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Change in quantitative liver Fibrosis (qFibrosis)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["flagstaff-arizona","peoria-arizona","tucson-arizona","canoga-park-california","chula-vista-california","coronado-california","gardena-california","huntington-park-california","lancaster-california","long-beach-california","los-angeles-california","orange-california","panorama-city-california","pasadena-california","poway-california","rialto-california","san-diego-california","aurora-colorado","bradenton-florida","hialeah-gardens-florida","jupiter-florida","miami-florida","orlando-florida","indianapolis-indiana","newburgh-indiana","metairie-louisiana","baltimore-maryland","flowood-mississippi","st-louis-missouri","new-york-new-york","danville-pennsylvania","hershey-pennsylvania","philadelphia-pennsylvania","austin-texas","brownsville-texas","cedar-park-texas","dallas-texas","edinburg-texas","fort-worth-texas","friendswood-texas","georgetown-texas","houston-texas","katy-texas","pharr-texas","san-antonio-texas","stafford-texas","murray-utah","charlottesville-virginia","richmond-virginia","sapporo-japan","guaynabo-puerto-rico","san-juan-puerto-rico","seongnam-si-south-korea","busan-south-korea","daegu-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 2: testing ALN-HSD for Metabolic Dysfunction-Associated SteatoHepatitis (MASH)","inPlainEnglish":"This study is researching an investigational drug, ALN-HSD called \"study drug\". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH).","whoItsFor":["Ages 18 Years to 75 Years","Adult male or female ≥18 years (or country's legal age of adulthood)","A diagnosis of MASH with Fibrosis (F) stage 2 or 3, according to the NASH-CRN","NAS score ≥3, as defined in the protocol","Meets genotype criteria for study enrollment, as defined in the protocol","Has a protocol defined FibroScan®-AST (FAST) score at screening or within approximately 12 weeks of screening"],"whoShouldSkip":["Evidence of other forms of known chronic liver disease, as defined in the protocol","Known history of alcohol or other substance abuse within the last year or at any time during screening, as defined in the protocol","History of Type 1 diabetes","Bariatric surgery within approximately 5 years prior to or planned during the study period","Prior exposure to any investigational drug targeting HSD17B13 or patatin-like phospholipase domain containing 3 (PNPLA3) (eg, ALN-HSD, ARO-HSD, ALN-PNP, AZD2693)","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ALN-HSD, or Placebo. The registry lists allocation as randomized. This study is researching an investigational drug, ALN-HSD called \"study drug\".","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.163Z"},{"nctId":"NCT05519683","title":"Home Transcutaneous Electrical Acustimulation (TEA)","officialTitle":"Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS)","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"This study will assess the efficacy of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.","conditions":["Irritable Bowel Syndrome With Constipation"],"keywords":["Irritable Bowel Syndrome with Constipation","Constipation","Irritable Bowel Syndrome","Colon, Irritable","Irritable Colon"],"interventions":[{"type":"DEVICE","name":"TEA"},{"type":"DRUG","name":"Lexapro"}],"enrollment":160,"startDate":"2022-11-02","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)\n* Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period\n* Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis.\n* Abdominal pain is not adequately relieved at the time of screening and the time of randomization.\n\nExclusion Criteria:\n\n* Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease.\n* Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation.\n* Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study\n* A history of abdominal surgery (other than cholecystectomy or appendectomy)\n* Active use of prucalopride, domperidone, alosetron, tegaserod, warfarin, antipsychotic (e.g., Seroquel, Risperdal), antidiarrheal, or frequent (\\>2 days/week) use of opioid or antispasmodic medication. Those who frequently use Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) will also be excluded.\n* Ongoing use of Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), or any other serotonin-active medications, including tricyclic antidepressants (TCAs). Individuals on chronic SSRI therapy, including escitalopram, at the initial evaluation will not be enrolled in the study.\n* Inability to avoid the following medications: tricyclic antidepressants, Monoamine Oxidase (MAO) inhibitors including, intravenous methylene blue, linezolid, and pimozide, as well as triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John's Wort. - - Participants will be informed that MAO inhibitors cannot be used within 14 days of starting or stopping escitalopram.\n* Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations.\n* Known allergy to adhesive Electrocardiogram (ECG) electrodes.\n* Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts.\n* Known QTc prolongation or receiving scheduled therapy with a medication associated with prolongation of QTc (screening to be completed at recruitment as detailed above).","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Colin Burnett","phone":"734-647-2806","email":"bucolin@med.umich.edu"}],"primaryOutcomes":["Change in abdominal pain/discomfort via daily Visual Analog Scale (VAS) survey","Change in global abdominal pain"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Lexapro for Irritable Bowel Syndrome With Constipation","inPlainEnglish":"This study will assess the how well it works of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.","whoItsFor":["Ages 18 Years to any","Those with ongoing and symptomatic Irritable Bowel Syndrome with Constipation (IBS-C)","Significant mean worst abdominal pain severity (as defined by the study protocol, which will be shared with results reporting) on a Visual Analog Scale (VAS) pain score during the Phase-in period","Symptoms present at least 1 day/week in the last 3 months with symptom onset at least 6 months prior to the diagnosis","Abdominal pain is not adequately relieved at the time of screening and the time of randomization"],"whoShouldSkip":["Unrelated active disorder which may involve abdominal pain, such as inflammatory bowel disease, diabetes or unstable thyroid disease","Pregnancy, plans to become pregnant, or lactation. Any potential patient of child-bearing potential will complete a pregnancy test at Visit 1 and if the test is positive that individual will be excluded from future participation","Any other condition, which in the opinion of the investigator would impede compliance or hinder the completion of the study","A history of abdominal surgery (other than cholecystectomy or appendectomy)","Known hypersensitivity to escitalopram or citalopram including any of the inactive ingredients of these formulations","Known allergy to adhesive Electrocardiogram (ECG) electrodes","Known angle-closure glaucoma, bipolar disorder, history of seizures or prior suicide attempt or known suicidal thoughts"],"whatHappens":"If you join, the listed intervention(s) are TEA, or Lexapro. The registry lists allocation as randomized. This study will assess the how well it works of two active treatments with TEA and a chemical neuromodulator (escitalopram aka Lexapro) versus a sham comparator or control group on abdominal pain.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 160 people at Ann Arbor. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.439Z"},{"nctId":"NCT05536141","title":"A Phase 1 Study of AB521 Monotherapy and Combination Therapies in Renal Cell Carcinoma and Other Solid Tumors","officialTitle":"A Phase 1, Open-label, Dose Escalation and Dose Expansion Study, to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of AB521 Monotherapy and Combination Therapies in Participants With Clear Cell Renal Cell Carcinoma and Other Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Arcus Biosciences, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and tolerability of:\n\n* casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and\n* casdatifan monotherapy and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.","conditions":["Clear Cell Renal Cell Carcinoma","Solid Tumors"],"keywords":["Clear Cell Renal Cell Carcinoma","AB521","Casdatifan","Kidney Cancer","Zimberelimab","AB122","Hif2a"],"interventions":[{"type":"DRUG","name":"casdatifan"},{"type":"DRUG","name":"Cabozantinib"},{"type":"DRUG","name":"Zimberelimab"},{"type":"DRUG","name":"Ipilimumab"}],"enrollment":362,"startDate":"2022-10-26","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Must have at least one measurable lesion per RECIST guidance\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1\n* Disease-specific criteria for dose escalation:\n\n  * Participants may have any pathologically confirmed solid tumor type where no other treatment options are available\n  * Creatinine clearance ≥ 40 mL/min\n\nDisease-specific criteria for dose-expansion:\n\n* Histologically confirmed ccRCC\n* Creatinine clearance ≥ 40 mL/min\n\nKey Exclusion Criteria:\n\n* Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product\n* Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous\n* History of trauma or major surgery within 28 days prior to the first dose of investigational product\n* For all expansion cohorts: prior treatment with an hypoxia inducible factor (HIF)-2α inhibitor. For the casdatifan + cabozantinib combination cohort, any prior treatment with cabozantinib. For casdatifan + zimberelimab and casdatifan + zimberelimab + ipilimumab cohorts, any prior systemic treatment when cancer is present.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Camperdown","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sydney","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical Director","phone":"+1-510-462-3330","email":"ClinicalTrialInquiry@arcusbio.com"}],"primaryOutcomes":["Number of participants with dose limiting toxicities (DLTs)","Number of participants with adverse events (AEs)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","san-diego-california","santa-monica-california","miami-florida","atlanta-georgia","louisville-kentucky","new-orleans-louisiana","baltimore-maryland","boston-massachusetts","detroit-michigan","omaha-nebraska","new-york-new-york","cleveland-ohio","pittsburgh-pennsylvania","nashville-tennessee","san-antonio-texas","camperdown-australia","melbourne-australia","sydney-australia","seoul-south-korea","barcelona-spain"],"enrichment":{"headline":"Phase 1: testing casdatifan for Clear Cell Renal Cell Carcinoma","inPlainEnglish":"This study wants to measure the whether it is safe and how hard side effects are to live with of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan this drug alone and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.","whoItsFor":["Ages 18 Years to any","Must have at least one measurable lesion per RECIST guidance","Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1","Disease-specific criteria for dose escalation:","Participants may have any pathologically confirmed solid tumor type where no other treatment options are available","Creatinine clearance ≥ 40 mL/min","Disease-specific criteria for dose-expansion:","Histologically confirmed ccRCC"],"whoShouldSkip":["Use of any live vaccines against infectious diseases (eg, influenza, varicella) within 4 weeks (28 days) of initiation of investigational product","Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with a participant's participation in the clinical study or make the administration of investigational product hazardous","History of trauma or major surgery within 28 days prior to the first dose of investigational product","Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are casdatifan, Cabozantinib, or Zimberelimab. The registry lists allocation as randomized. This study wants to measure the whether it is safe and how hard side effects are to live with of: * casdatifan when taken alone in participants with advanced solid tumor malignancies and clear cell renal cell carcinoma (ccRCC) during the dose escalation stage; and * casdatifan this drug alone and casdatifan in combination with cabozantinib or zimberelimab or zimberelimab and ipilimumab in participants with ccRCC in the dose expansion stage.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 362 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.934Z"},{"nctId":"NCT05538910","title":"Defining Neurobiological Links Between Substance Use and Mental Illness","officialTitle":"Defining Neurobiological Links Between Substance Use and Mental Illness","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"National Institute on Drug Abuse (NIDA)","sponsorClass":"NIH","summary":"Background:\n\nNicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (MDD) are twice as likely to use nicotine compared to the general population. They have greater withdrawal symptoms and are more likely to relapse after quitting compared with smokers without MDD. More research is needed on how nicotine affects brain function in those with MDD.\n\nObjective:\n\nTo understand how nicotine affects symptoms of depression and related brain function.\n\nEligibility:\n\nPeople aged 18 to 60 years, at the time of consent, with and without MDD who do not smoke cigarettes or use other nicotine products.\n\nDesign:\n\nParticipants will have 2 or 3 study visits over 1 year.\n\nParticipants will have 2 MRI scans no less than 4 days apart. Each scan visit will last 5 to 7 hours. At each scan, they will have urine and breath tests to screen for recent use of alcohol, nicotine, and illegal drugs.\n\nBefore each scan, they will take 1 of 2 medications: nicotine or placebo. Participants will receive each medication once. They will not know which medication they are receiving at each scan.\n\nFor each MRI scan, they will lie on a table that slides into a cylinder. Sometimes they will be asked to lie still. Sometimes they will complete tasks on a computer. Tasks may include identifying colors or playing games to win money. Each scan will take about 2 hours.\n\nParticipants will answer questions about their thoughts, feelings, and behaviors before and after each scan.\n\nThey will have a blood test after each scan.","conditions":["Major Depressive Disorder","Substance Use Disorder","Normal Physiology"],"keywords":["fMRI","Reward Function","Affective Processing","Interoceptive Awareness"],"interventions":[{"type":"OTHER","name":"Placebo Nicotine Patch"},{"type":"DRUG","name":"Nicotine Patch"}],"enrollment":620,"startDate":"2023-02-02","completionDate":"2027-12-30","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible for this study, an individual must meet all the following criteria assessed under the currently approved NIDA IRP screening protocol for the evaluation of potential research subjects (here referred to as the NIDA screening protocol). This is a protocol led by the Office of the Clinical Director (OCD) at the National Institute on Drug Abuse Intramural Research Program (NIDA IRP) to assess potential research participants eligibility for entering clinical protocols at the NIDA/IRP. Additional details can be found in the NIDA screening protocol documents. As routinely done at the NIDA IRP, the screening procedures and data collected under the NIDA\n\nscreening protocol will capture information above and beyond what is necessary to determine eligibility for this protocol but allows the Investigators to assess the eligibility criteria for this protocol.\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAll Participants:\n\n1. Able and willing to provide written informed consent.\n2. Both sexes and all ethnic origins, age between 18 and 60 at the time of consent.\n3. Absence of pregnancy and breastfeeding.\n4. Have a Breath Alcohol Value of 0 on all study visit days involving scanning. Participant may be rescheduled if this value is greater than 0.\n\nMDD Subjects:\n\n1. Meet DSM-5 diagnostic criteria for current MDD at screening Clinical judgement will be used to interpret criteria.\n2. Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff.\n3. Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI\n\nRemitted MDD Subjects:\n\n1. Meet DSM-5 diagnostic criteria for remitted MDD (full remission or partial remission or past depression) Clinical judgement will be used to interpret criteria.\n2. HAM-D score indicating no clinically relevant depression as evaluated by clinical staff.\n3. Current stable serotonin modulating drug (e.g. SSRI/SNRI/serotonin modulator) treatment is allowed (no changes in the last 2 months). Specific medications will be evaluated by the MAI.\n\nControl Subjects (without MDD):\n\n1. Control participants must not have current/lifetime MDD. Clinical judgement will be used to interpret criteria.\n2. HAM-D score indicating no clinically-relevant depression as evaluated by clinical staff.\n\nDaily Nicotine Users (Study Arm 2):\n\n1. Uses nicotine daily for at least six months\n2. Positive urine screen for cotinine\n\nEXCLUSION CRITERIA (STUDY ARM 1):\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Subjects with suicidal ideation where outpatient treatment is determined unsafe.\n2. Lifetime history or current diagnosis of any of the following psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features. The MAI and/or PI/LI will reserve the right to exclude based psychiatric history not explicitly described in this criterion\n\n   a. Within the control group, current use of antidepressants for psychiatric reasons will be exclusionary. The MAI reserves the right to evaluate use of antidepressants for non-psychiatric uses as appropriate for participation in the study.\n3. Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability. Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited during laboratory task performance.\n4. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.\n5. May not have used any nicotine product weekly or more frequently than weekly in the past year; must never have been daily nicotine users for more than 1 month.\n6. Must have an expired carbon monoxide level of less than or equal to 5 ppm and cotinine levels consistent with a non-smoker. Depending on the commercially available test used, a level equivalent to a non-smoker status will be used, ideally indicative of a urine cotinine level of around 10 ng/ml. However, given the known limitations of rapid tests to return specific quantifications of cotinine levels, if the present test is unable to quantify cotinine at this level, the lowest level of detection will be used as a cut off and MAI/PI discretion may be used to determine whether this cut off coupled with participant history and environmental factors indicates personal nicotine use versus secondhand smoke environment. If expired carbon monoxide level is greater than 5 ppm and cotinine levels consistent with a non-smoker, the MAI/PI will reserve the right to assess the participant's full clinical picture to determine the source of CO readings over 5 ppm. If the source is unlikely to be from personal nicotine use (e.g., negative cotinine test and participant states exposure to secondhand smoke environment, etc.), the CO test may be re-run until a lower reading is obtained, or the participant can be rescheduled.\n7. History of moderate or severe substance use disorder in the past 6 months (other than caffeine)\n8. Current pharmacological treatment for opioid use disorder (i.e., use of methadone)\n9. Current use of illegal drugs other than marijuana as measured by urine drug screen Marijuana will not be allowed in the 24 hours prior to scanning based on self-report. Study day can be rescheduled to accommodate.\n10. Participants may not use anticholinergic drugs (i.e., scopolamine), dopamine enhancing drugs (i.e. methylphenidate), or other medications that may impact MRI measures (i.e. benzodiazepines) prior to any scanning visit within a timeframe that is likely to directly\n\n    impact the study questions. MAI discretion regarding timeframe of allowed use will be based on half-life, pharmacology of the drug in question, and pattern of use by the participant. Scanning visit timing can be adjusted to accommodate.\n11. May not use drugs that directly enhance dopamine (i.e., methylphenidate) in the week prior to any scanning visit. Scanning visit timing can be adjusted to accommodate.\n12. Any past or present significant cardiovascular, cerebrovascular, or respiratory conditions, including arrhythmias, acute coronary syndrome, ischemic heart disease, or, uncontrolled hypertension. The MAI may use their clinical judgement to interpret this criterion.\n13. Body mass index (BMI) lower than 18.5 kg/m\\^2\n14. Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).\n15. Abnormal structural MRI or significant head trauma. The MAI may use their clinical judgement to interpret this criterion.\n16. Current neurological illness including but not limited to frequent migraines, multiple sclerosis, movement disorder. The MAI may use their clinical judgement to interpret this criterion.\n17. Lifetime history of significant seizure disorder\n18. Any other serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators would compromise the safety of an individual during participation\n\n    All data collected will be evaluated by members of the study team to decide if there is an existing medical illness that would compromise participation in this research\n19. Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the\n\nsmall sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants\n\nExclusion Criteria (Study Arm 2)\n\n1. Subjects with active suicidal ideation where outpatient treatment is determined unsafe.\n2. Current psychiatric symptoms in which the ability to adhere to study protocol is determined to be impaired by clinical staff/MAI (e.g., difficulty understanding or answering questions, difficulty remaining still in the fMRI scanner)\n3. Are cognitively impaired or have a learning disability severe enough to have required intervention throughout most or all of K-12 education. The MAI will reserve the right to evaluate if a participant s history of educational placement is likely to represent a learning disability that could significantly impact the data gathered in this study based on the severity and type of learning disability.\n\n   Justification: Cognitive impairment and learning disabilities may be associated with altered brain functioning in regions recruited\n\n   during laboratory task performance.\n4. Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). Participants will be asked to not deviate from their typical caffeine use on all scanning days.\n5. Active severe substance use disorder in the past 6 months (other than caffeine and nicotine)\n6. Contraindications to MRI as determined by MRI Safety Screening form and mock scanner trial (when available).\n7. Abnormal structural MRI, significant head trauma, current neurological illness likely to impact fMRI signal or ability to comply with study requirements (e.g., staying still in scanner). The MAI may use their clinical judgement to evaluate this criterion.\n8. Any serious or unstable medical illness as defined by self-report, the evaluation of vital signs or other observation that in the view of the investigators, would compromise the safety of an individual during participation. All data collected will be evaluated by members of the study team to decide if there is an existing medical illness that would compromise participation in this research\n9. Subjects that cannot speak English. Justification: To include non-English speakers, we would have to translate the consent and other study documents and hire and train bilingual staff, which would require resources that we do not have and could not justify, given the small sample size for each experiment. Additionally, the data integrity of some of the cognitive tasks and standardized questionnaires used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing MRI procedures. The inability to effectively communicate MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants","locations":[{"facility":"National Institute on Drug Abuse","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NIDA IRP Screening Team","phone":"(800) 535-8254","email":"researchstudies@nida.nih.gov"},{"name":"Amy C Janes, Ph.D.","phone":"(667) 312-5164","email":"amy.janes@nih.gov"}],"primaryOutcomes":["4.Nicotine effects and symptoms of MDD","3. Task and Resting State Brain","2.Task-fMRI","1.Resting-fMRI"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: testing Nicotine Patch for Major Depressive Disorder","inPlainEnglish":"Background: Nicotine dependence leads to about 480,000 deaths every year in the United States. People with major depressive disorder (major depression) are twice as likely to use nicotine compared to the general population.","whoItsFor":["Ages 18 Years to 60 Years","screening protocol will capture information above and beyond what is necessary to determine eligibility for this protocol but allows the Investigators to assess the eligibility criteria for this protocol","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Both sexes and all ethnic origins, age between 18 and 60 at the time of consent","Absence of pregnancy and breastfeeding","Have a Breath Alcohol Value of 0 on all study visit days involving scanning. Participant may be rescheduled if this value is greater than 0","Meet DSM-5 diagnostic criteria for current major depression at screening Clinical judgement will be used to interpret criteria","Have a baseline (Hamilton Depression) HAM-D score indicative of current depression as evaluated by clinical staff"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Subjects with suicidal ideation where outpatient treatment is determined unsafe","a. Within the control group, current use of antidepressants for psychiatric reasons will be exclusionary. The MAI reserves the right to evaluate use of antidepressants for non-psychiatric uses as appropriate for participation in the study","Heavy caffeine users (consume greater than 500 mg on a regular or daily basis. This is approximately five 8 fl oz cups of coffee). you would be asked to not deviate from their typical caffeine use on all scanning days","May not have used any nicotine product weekly or more frequently than weekly in the past year; must never have been daily nicotine users for more than 1 month","History of moderate or severe substance use disorder in the past 6 months (other than caffeine)","Current pharmacological treatment for opioid use disorder (i.e., use of methadone)"],"whatHappens":"If you join, the listed intervention(s) are Placebo Nicotine Patch, or Nicotine Patch. The registry lists allocation as randomized. Background: Nicotine dependence leads to about 480,000 deaths every year in the United States.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 620 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.122Z"},{"nctId":"NCT05541341","title":"Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies","officialTitle":"Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies: a 15-year Prospective Registry Study on Three Cohorts.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This will be a multicenter, national, non-interventional, prospective cohort study","conditions":["Diffuse Large B-cell Lymphoma","Acute Lymphoblastic Leukemia","Follicular Lymphoma"],"keywords":["Diffuse Large B-cell Lymphoma","DLBCL","Acute Lymphoblastic Leukemia","ALL","Tisagenlecleucel","Brazil","NIS","Follicular Lymphoma"],"interventions":[{"type":"OTHER","name":"tisagenlecleucel"}],"enrollment":200,"startDate":"2023-11-24","completionDate":"2037-11-23","sex":"ALL","minAge":"0 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatients eligible for inclusion in this study must meet the following criteria:\n\n1. Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND\n2. Signed informed consent must be obtained prior to participation in study, AND\n\n   For ALL participants:\n3. Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR\n4. Patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR\n\n   For DBLCL and FL participants:\n5. Patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel infusion.\n\nExclusion Criteria:\n\n1. Patients who did not consent to data collection.\n2. Patients who received tisagenlecleucel infusion as part of any interventional clinical trial.","locations":[{"facility":"Novartis Investigative Site","city":"Minas Gerais","state":"Belo Horizonte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Overall response rate (ORR)","MRD negative overall response rate","Duration of overall response (DOR)","Relapse-free survival (RFS)","Event-free survival (EFS) for ALL patients","Progression free survival (PFS) for DLBCL patients","Overall survival (OS)","Number of ALL patients with hematologic recovery"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["minas-gerais-brazil","salvador-brazil","curitiba-brazil","s-o-paulo-brazil"],"enrichment":{"headline":"Not a traditional drug phase: tisagenlecleucel for Diffuse Large B-cell Lymphoma","inPlainEnglish":"This will be a multicenter, national, non-treatment, prospective cohort study","whoItsFor":["Ages 0 Years to 100 Years","Patients eligible for inclusion in this study must meet the following criteria:","Patients who receive tisagenlecleucel infusion in the commercial setting or out-of-specification (OOS) use, AND","For ALL participants:","Patients of any gender aged 0-17 years (named as pediatric) with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR","Patients of any gender, aged 18-25 years (named as adults) - with relapsed/ refractory B-cell ALL diagnosis that received tisagenlecleucel infusion, OR","For DBLCL and FL participants:","Patients of any gender aged 18 years or older, who have been diagnosed with relapsed/ refractory Diffuse Large B-cell Lymphoma and received tisagenlecleucel infusion"],"whoShouldSkip":["Patients who did not consent to data collection","Patients who received tisagenlecleucel infusion as part of any treatment clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.809Z"},{"nctId":"NCT05551793","title":"Regeneron AA Multicenter (Dupilumab)","officialTitle":"Dupilumab in the Treatment of Alopecia Areata Patients With an Atopic Background and/or High IgE","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Emma Guttman","sponsorClass":"OTHER","summary":"This is a prospective, randomized, double blind, placebo-controlled clinical trial. The study will take place at 4 sites. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48. AA subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥ 200 and/or have personal and/or familial history of atopy.\n\nSubjects will be randomized (2:1) to either receive weekly dupilumab or placebo for 48 weeks, with all subjects completing participation through Week 48 receiving an additional 48 weeks of dupilumab (through Week 96).","conditions":["Alopecia Areata"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":76,"startDate":"2023-04-10","completionDate":"2027-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\n* Male or female subjects who are at least 18 years old at the time of informed consent.\n* Subject is able to understand and voluntarily sign an informed consent document prior to participation in any study assessments or procedures.\n* Subject is able to adhere to the study visit schedule and other protocol requirements.\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:\n\n  * Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR;\n  * Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]); PLUS one additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.\n* If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy.\n* Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score; OR subject has ≥ 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes.\n* Subject has a screening IgE \\> 200 and/or personal and/or familial history of atopy.\n* Subjects must meet the following laboratory criteria:\n\n  * White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and \\< 14,000/mm3 (≤ 14 x 109/L).\n  * Platelet count ≥ 100,000/μL (≥ 100 x 109/L).\n  * Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L).\n  * AST (SGOT) and ALT (SGPT) ≤ 2 x upper limit of normal (ULN). If the initial test shows ALT or AST \\> 2 times the ULN, one repeat test is allowed during the Screening Phase.\n  * Total bilirubin ≤ 2 mg/dL (34 μmol/L). If the initial test shows total bilirubin \\> 2 mg/dL (34 μmol/L), one repeat test is allowed during the Screening Phase.\n  * Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L).\n* Subject is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.\n\nEXCLUSION CRITERIA:\n\nThe presence of any of the following will exclude a subject from enrollment:\n\n* Subject is pregnant or breastfeeding.\n* Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).\n* Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.\n* Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.\n* Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics\n* Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.\n* Subject has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.\n* Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology or active or untreated latent tuberculosis at the time of screening for subjects determined by the investigators to be at high-risk for this disease.\n* Subject has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.\n* Subject has received a live attenuated vaccine ≤ 30 days prior to study randomization.\n* Subject has any uncertain or clinically significant laboratory abnormalities that may affect interpretation of study data or endpoints.\n* Subject has any other medical or psychological condition that, in the opinion of the investigator, may present additional unreasonable risks as a result of their participation in the study and/or interfere with clinic visits and necessary study assessments.\n* History of adverse systemic or allergic reactions to any component of the study drug.\n* Severe, untreated asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations.\n* Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy within 4 weeks prior to randomization.\n* Use of an oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, or investigational oral JAK Inhibitors) within 12 weeks prior to the Baseline visit.\n* Subject has been previously treated with dupiliumab.\n* Subject has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.\n* Subject currently uses or plans to use anti-retroviral therapy at any time during the study.","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UR Dermatology at College Town","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Giselle Singer","phone":"212-241-3288","email":"giselle.singer@mssm.edu"},{"name":"Sharlene Martin","phone":"212-241-3288","email":"sharlene.martin@mssm.edu"}],"primaryOutcomes":["Change in the SALT score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["irvine-california","new-york-new-york","rochester-new-york"],"enrichment":{"headline":"Phase 2: testing Dupilumab for Alopecia Areata","inPlainEnglish":"This is a prospective, randomly assigned, double blind, compared with a dummy treatment clinical trial. This trial will enroll a total of 68 patients with moderate to severe AA (affecting more than 50% of the scalp) at the time of screening with a targeted 54 subjects completers through Week 48.","whoItsFor":["Ages 18 Years to any","Subject is able to adhere to the study visit schedule and other protocol requirements","Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy, OR;","If subject is a female of non-childbearing potential, she must have documented history of infertility, be in a menopausal state for one year, or had a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy","Subject has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score; OR subject has ≥ 95% loss of scalp hair for enrollment as AA totalis (AT) or universalis (AU) subtypes","Subject has a screening IgE \\> 200 and/or personal and/or familial history of atopy","Subjects must meet the following laboratory criteria:","White blood cell count ≥ 3000/mm3 (≥ 3.0 x 109/L) and \\< 14,000/mm3 (≤ 14 x 109/L)"],"whoShouldSkip":["The presence of any of the following will exclude a subject from enrollment:","Subject is pregnant or breastfeeding","Subject's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V)","Subject has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss","Severe, uncontrolled asthma or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic mediations","Subject has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics","Subject with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. This is a prospective, randomly assigned, double blind, compared with a dummy treatment clinical trial.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 76 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.714Z"},{"nctId":"NCT05554406","title":"Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)","officialTitle":"A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. \"High-risk\" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.","conditions":["Acute Myeloid Leukemia","Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemia, Myelodysplasia-Related"],"keywords":[],"interventions":[{"type":"DRUG","name":"Azacitidine"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"DRUG","name":"Cytarabine"},{"type":"DRUG","name":"Daunorubicin Hydrochloride"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Liposome-encapsulated Daunorubicin-Cytarabine"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Venetoclax"}],"enrollment":335,"startDate":"2024-09-25","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":"59 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1 REGISTRATION:\n* Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.\n\n  * Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH\n* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria\n* Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria\n* Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible-unless they were previously treated\n* Acute promyelocytic leukemia is excluded\n* Participants with favorable or intermediate risk disease per ELN 2017 criteria are excluded\n* Participants with FLT3 mutations (ITD or TKD) are excluded\n* Participants with t(9;22) translocation are excluded\n* A single dose of intrathecal chemotherapy for AML is allowed prior to study entry\n* Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\\^2 daunorubicin or equivalent\n* Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. For urgent cytoreduction, cytarabine may be given either as a single dose or in multiple doses not to exceed 2500 mg\n* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy\n* Participants must be between 18 and 59 years of age\n* Participants must have Zubrod performance status =\\< 3 as determined by a complete medical history and physical exam (H\\&P) completed within 7 days prior to registration\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration\n* The following tests must be performed within 14 days prior to registration to establish baseline values:\n\n  * Complete blood count (CBC)/differential/platelets\n  * Total bilirubin\n  * Lactate dehydrogenase (LDH)\n  * Albumin\n  * Glucose\n  * Fibrinogen\n* Participants must have adequate kidney function as evidenced by creatinine clearance \\>= 30mL/min (by Cockcroft Gault) within 7 days prior to registration\n* Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) within 7 days prior to registration- unless elevations are considered due to leukemia in the opinion of the treating investigator\n* Total bilirubin =\\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration\n* Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \\>= 50% within 28 days prior to registration\n* Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy\n* Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease.\n* Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded\n* Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \\[examples include birth control pills, vaginal rings, or patches\\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown\n* Participants must have agreed to have specimens submitted for translational medicine (MRD) under MYELOMATCH and specimens must be submitted\n* Participants must be offered the opportunity to participate in specimen banking\n\n  * Note: Specimens must be collected and submitted using the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alta Bates Summit Medical Center-Herrick Campus","city":"Berkeley","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Roseville","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical 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Momi Medical Center","city":"‘Aiea","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Boise","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Boise","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Caldwell","city":"Caldwell","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Fruitland","city":"Fruitland","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Meridian","city":"Meridian","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Joseph Medical Center","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Bloomington","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Canton","city":"Canton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Carthage","city":"Carthage","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois - Decatur","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Decatur Memorial Hospital","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Dixon","city":"Dixon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crossroads Cancer Center","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Eureka","city":"Eureka","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University HealthSystem-Evanston Hospital","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Galesburg","city":"Galesburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University HealthSystem-Glenbrook Hospital","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University HealthSystem-Highland Park Hospital","city":"Highland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Kewanee Clinic","city":"Kewanee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Macomb","city":"Macomb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loyola University Medical Center","city":"Maywood","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Comprehensive Cancer Center at Silver Cross","city":"New Lenox","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medicine-Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Ottawa Clinic","city":"Ottawa","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Pekin","city":"Pekin","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peoria","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Methodist Medical Center of Illinois","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Francis Medical Center","city":"Peoria","state":"Illinois","country":"United 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Medicine Northwest Indiana","city":"Crown Point","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University/Melvin and Bren Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa/Holden Comprehensive Cancer Center","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Clinical Research Center","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Cancer Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Hospital-Indian Creek Campus","city":"Overland Park","state":"Kansas","country":"United 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2: testing Azacitidine for Acute Myeloid Leukemia","inPlainEnglish":"This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. \"High-risk\" refers to traits that have been known to make the AML harder to treat.","whoItsFor":["Ages 18 Years to 59 Years","STEP 1 REGISTRATION:","Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study","Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH","Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria","Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria","Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible-unless they were previously treated","Acute promyelocytic leukemia is excluded"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Azacitidine, Biospecimen Collection, or Bone Marrow Aspiration. The registry lists allocation as randomized. This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 335 people at 227 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.818Z"},{"nctId":"NCT05558059","title":"Imaging Retinal Vasculature in Infant Eyes","officialTitle":"Elucidating Perifoveal Vasculature Development in Infants","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Duke University","sponsorClass":"OTHER","summary":"Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity. However, how these blood vessels form during development of the human fovea remains unclear. This research will advance our understanding of the fundamental knowledge of how the blood vessels around the fovea form in infants, and how they change in diseased states such as preterm birth or retinopathy of prematurity.","conditions":["Retinopathy of Prematurity"],"keywords":["Retinopathy of Prematurity","Optical Coherence Tomography","Perifoveal vasculature","Vascular development","Macular edema","ROP","OCT","Prematurity","Optical Coherence Tomography Angiography","OCTA"],"interventions":[{"type":"DEVICE","name":"Handheld Optical Coherence Tomography with OCT Angiography"}],"enrollment":16,"startDate":"2024-10-03","completionDate":"2027-08-31","sex":"ALL","minAge":null,"maxAge":"2 Months","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian\n* Parent/Legal Guardian is able and willing to consent to study participation for the infant\n* Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit\n\nExclusion Criteria:\n\n* Participant or Parent/Legal Guardian unwilling or unable to provide consent\n* Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)\n* Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)","locations":[{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphi","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xi Chen, MD","phone":"(919) 684-8434","email":"xi2.chen@duke.edu"},{"name":"Michelle N McCall","phone":"(919) 684-0544","email":"michelle.mccall@duke.edu"}],"primaryOutcomes":["Change in vascular density of intermediate and deep vascular plexus at the fovea and perifovea"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["durham-north-carolina","philadelphi-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Handheld Optical Coherence Tomography with OCT Angiography for Retinopathy of Prematurity","inPlainEnglish":"Retinopathy of prematurity is a leading cause of childhood blindness worldwide. The fovea, a critical location in the retina determining visual acuity and visual function, and the blood vessels around it, are abnormally developed in infants with retinopathy of prematurity.","whoItsFor":["Ages any to 2 Months","Health care provider, knowledgeable of protocol, agrees that study personnel could contact the Parent/Legal guardian","Parent/Legal Guardian is able and willing to consent to study participation for the infant","Infant meets the American Association of Pediatrics eligibility of ROP screening, and is age less than 34 6/7 weeks postmenstrual age at first visit"],"whoShouldSkip":["Infant has a health or eye condition that preclude eye examination or retinal imaging (e.g. corneal opacity such as with Peter's anomaly or cataract)","Infant has a health condition, other than prematurity, that has a profound impact on brain development (e.g. anencephaly)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 16 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.153Z"},{"nctId":"NCT05559463","title":"Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis","officialTitle":"Effect of Anti-inflammatory (ITIS) Diet in Knee Osteoarthritis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis","conditions":["Osteoarthritis, Knee"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"ITIS diet"}],"enrollment":30,"startDate":"2021-10-01","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients diagnosed of Knee Ostoeaarthritis\n* without changes in treatment in the last 3 months\n\nExclusion Criteria:\n\n* food allergies\n* pregnancy","locations":[{"facility":"UCSD","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Monica Guma, MD, PhD","phone":"8588226523","email":"mguma@ucsd.edu"}],"primaryOutcomes":["Change of baseline pain measured by visual analogue scale (0-10) after 28 days"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Not a traditional drug phase: ITIS diet for Osteoarthritis, Knee","inPlainEnglish":"To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis","whoItsFor":["Ages 18 Years to any","patients diagnosed of Knee Ostoeaarthritis","without changes in treatment in the last 3 months"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are ITIS diet. The registry lists allocation as na. To study the effect of anti-inflammatory diet on clinical and biological outcomes in patients with knee osteoarthritis","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at La Jolla. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.506Z"},{"nctId":"NCT05559671","title":"Safety of the Herpes Zoster Subunit Vaccine in Lupus","officialTitle":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Non-inferiority Crossover Study Evaluating the Safety and Immunogenicity of the Herpes Zoster Subunit Vaccine in Patients With Systemic Lupus Erythematosus","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"This randomized, double-blind, placebo-controlled, non-inferiority crossover study will evaluate the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to placebo with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment. In addition, the investigators hypothesize that immunogenicity of the vaccine in SLE patients will be at least 50% of levels observed in healthy subjects from prior large clinical trials.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Herpes Zoster Subunit Vaccine"],"interventions":[{"type":"BIOLOGICAL","name":"Herpes Zoster Subunit (HZ/su) Vaccine"},{"type":"BIOLOGICAL","name":"Placebo"}],"enrollment":224,"startDate":"2023-12-21","completionDate":"2028-02-01","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female or male ≥18 years of age at the time of signing the informed consent\n3. Meet the 2019 EULAR/ACR Classification Criteria for SLE\n4. Female subjects must use 1 effective method of avoiding pregnancy, from the time they sign consent until end of the study period unless the subject is surgically sterile (e.g., bilateral oophorectomy or complete hysterectomy), has a sterile male partner, is at least 1 year postmenopausal, or practices sustained abstinence consistent with the subject's customary lifestyle. Postmenopausal is defined as at least 1 year since last menses and the subject has an elevated follicle-stimulating hormone (FSH) level greater than the threshold laboratory value of post-menopausal women at screening.\n\nExclusion Criteria:\n\n1. Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)\n2. Clinical HZ infection within 12 months prior to screening or during screening\n3. Hybrid SLEDAI \\>12 at screening visit\n4. Presence of a mild, moderate, or severe flare per the rSFI at time of screenin\n5. Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit\n6. Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment\n7. Receipt of rituximab or cyclophosphamide within nine months of enrollment\n8. Participation in an interventional clinical trial of SLE or other therapeutics within six months of enrollment\n9. Moderate to severe infectious febrile illness or use of systemic antibiotics (antibacterial, antiviral, antifungal, or antiparasitic agent) within 4 weeks of enrollment\n10. Are pregnant, nursing, or planning a pregnancy while enrolled in the study\n11. Known primary or secondary immunodeficiency (malignancy, HIV, common variable immune deficiency) or medications used during cancer chemotherapy","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Medical Research Foundation","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas Chalothron","phone":"646-501-7384","email":"Thomas.Chalothron@nyulangone.org"},{"name":"Janine Sullivan","phone":"646-501-7390","email":"Janine.Sullivan@nyulangone.org"}],"primaryOutcomes":["Occurrence of either Moderate or Severe Lupus Flares within 24 Weeks of First Dosing with HZ/su Vaccine"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["new-york-new-york","oklahoma-city-oklahoma"],"enrichment":{"headline":"Phase 4: testing Herpes Zoster Subunit (HZ/su) Vaccine for Systemic Lupus Erythematosus","inPlainEnglish":"This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, non-inferiority crossover study will measure the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures. The investigators hypothesize that HZ/su administration will be non-inferior to dummy treatment (placebo) with respect to the risk of moderate or severe SLE flare(s) occurring within 24 weeks of receiving the first dose of the assigned treatment.","whoItsFor":["Ages 18 Years to 90 Years","Meet the 2019 EULAR/ACR Classification Criteria for SLE"],"whoShouldSkip":["Prior administration of the Herpes Zoster subunit vaccine (Shingrix) or the Varicella-Zoster virus vaccine live (Zostavax)","Clinical HZ infection within 12 months prior to screening or during screening","Hybrid SLEDAI \\>12 at screening visit","Presence of a mild, moderate, or severe flare per the rSFI at time of screenin","Increase in clinical SLEDAI parameters at time of enrollment relative to screening visit","Any vaccine, including the final/booster dose of any SARS-CoV-2 vaccine, within six weeks enrollment","Receipt of rituximab or cyclophosphamide within nine months of enrollment"],"whatHappens":"If you join, the listed intervention(s) are Herpes Zoster Subunit (HZ/su) Vaccine, or Placebo. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, non-inferiority crossover study will measure the Herpes Zoster Sunbit (HZ/su) vaccine in SLE patients in order to evaluate safety and immunogenicity in patients with variable baseline clinical activities, ages and immunosuppressant exposures.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 224 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.284Z"},{"nctId":"NCT05560659","title":"Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy","officialTitle":"Lu-PSMA for Oligometastatic Prostate Cancer Treated With STereotactic Ablative Radiotherapy, a Randomised Phase II Parallel Cohort Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Peter MacCallum Cancer Centre, Australia","sponsorClass":"OTHER","summary":"The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.","conditions":["Oligometastatic Prostate Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"177Lu-PSMA"}],"enrollment":92,"startDate":"2023-12-14","completionDate":"2026-11","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male aged 18 years or older at screening\n2. Patient has provided written informed consent\n3. Histologically confirmed prostate adenocarcinoma w\n4. Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery\n5. Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT\n6. Adequate haematological function as defined by:\n\n   * Absolute neutrophil count (ANC) ≥1.5 x 109/L\n   * Platelet count \\>150x 109/L\n   * Haemoglobin ≥100 g/L\n   * Creatinine Clearance ≥ 40mL/min (Cockcroft-Gault formula)\n7. Assessed as suitable for SABR by a radiation oncologist\n8. Patients must agree to use an adequate method of contraception\n9. Have a performance status of 0-1 on the ECOG Performance Scale\n\nExclusion Criteria:\n\n1. Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal\n2. Any visceral (AJCCC M1c) metastases\n3. Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression\n4. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator\n5. Has a known additional malignancy that is progressing or required active treatment in the last 2 years Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or carcinoma in situ such as breast cancer in situ that has undergone potentially curative therapy are not excluded.","locations":[{"facility":"Royal North Shore","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icon Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Centre","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Haris Ahmad","phone":"+61 3 8559 8566","email":"haris.ahmad@petermac.org"},{"name":"Annette VanDerHeyden","phone":"+61488048792","email":"Annette.VanDerHeyden@petermac.org"}],"primaryOutcomes":["Evaluate the (bPFS) of SABR alone and SABR + 177Lu-PSMA"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["st-leonards-australia","melbourne-australia","tel-aviv-israel"],"enrichment":{"headline":"Phase 2: testing 177Lu-PSMA for Oligometastatic Prostate Cancer","inPlainEnglish":"The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.","whoItsFor":["Ages 18 Years to any","Men only","Male aged 18 years or older at screening","Histologically confirmed prostate adenocarcinoma w","Prior definitive treatment of the primary with either curative intent radiotherapy and/or surgery","Patient has 1-5 sites of nodal or bony metastases on 68Ga-PSMA or 18F-DCFPyL PET/CT","Adequate haematological function as defined by:","Absolute neutrophil count (ANC) ≥1.5 x 109/L","Platelet count \\>150x 109/L"],"whoShouldSkip":["Prior systemic therapy for metastatic prostate cancer. Prior ADT is allowed but ADT within 6 months of screening for the study is not allowed. If patients have received prior ADT, serum testosterone levels must be above the lower limit of normal","Any visceral (AJCCC M1c) metastases","Symptomatic cord compression, or clinical or imaging findings concerning for impending cord compression"],"whatHappens":"If you join, the listed intervention(s) are 177Lu-PSMA. The registry lists allocation as randomized. The aim of this study is to assess the progression free survival (PFS) of SABR alone and SABR + 177Lu-prostate-specific membrane antigen (PSMA) in patients with oligometastatic prostate cancer undergoing PSMA positron emission tomography (PET) staging.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 92 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.312Z"},{"nctId":"NCT05562466","title":"A Study to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate/Mometasone Furoate) Versus Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","officialTitle":"Double-blind, Randomized, Active-controlled, Two-way Cross-over Study, With 12-week Treatment Duration Per Period, to Evaluate the Efficacy and Safety of QMF149 (Indacaterol Acetate / Mometasone Furoate) Compared to Budesonide in Children From 6 to Less Than 12 Years of Age With Asthma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the superiority in terms of efficacy and evaluate the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.\n\n* The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.\n* The visit frequency will be 3 weeks for screening, run-in and wash-out period, 6 weeks interval for visits during each treatment period, 30 days for safety follow-up.","conditions":["Asthma"],"keywords":["Asthma","Pediatric","Breezhaler","QMF149","Budesonide"],"interventions":[{"type":"DRUG","name":"QMF149"},{"type":"DRUG","name":"Budesonide"}],"enrollment":200,"startDate":"2023-05-11","completionDate":"2028-02-01","sex":"ALL","minAge":"6 Years","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Male or female children ≥ 6 years and \\<12 years in age at randomization.\n2. Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period)).\n3. Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment.\n4. Written and signed informed consent by parent(s)/legal guardian(s) for the pediatric patient and assent by the pediatric patient (depending on local requirements) must be obtained before any study-specific assessment is performed.\n5. Patient receiving daily treatment of stable low dose ICS alone (i.e. up to 100ug daily dose of fluticasone propionate DPI or equivalent) without additional controller OR low dose ICS (up to 100ug daily dose of fluticasone propionate DPI or equivalent) with one additional controller prior to starting run-in and eligible after run-in on mono ICS alone (fluticasone 100ug/day) for at least 3 weeks (run-in period) prior to randomization.\n6. All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n\n   Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\<1.5 at Visit 20 and will be randomized if ACQ-IA score ≥1.5 at Visit 30.\n7. Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30).\n\n   Withholding period of bronchodilators prior to spirometry at all time:\n\n   SABA for ≥ 6 hours. For loose combinations of ICS/LABA\\* a wash-out of ≥ 48 hours before Visit 20 is required (14 days for once daily combinations, i.e. indacaterol), short acting anticholinergic (SAMA) for ≥ 8 hours and xanthines ≥7 days.\n\n   \\* In case of combination ICS/LABA at screening, ICS alone should be continued. Wash-out period of each drug should be adhered to as above and should not be longer. If wash-out period is considered to be longer, please contact the Novartis Medical Monitor.\n\n   A one-time repeat of percent predicted FEV1 (pre-bronchodilator FEV1) within 5 days of the Visit is allowed at Visit 20 as well as Visit 30. That would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment. At Visit 20, the Run-in medication should be dispensed only once the repeat spirometry was qualified, and if all inclusion criteria at Visit 20 are successfully met.\n\n   If patient fails to meet the pre FEV1 criteria for technical reasons, a rescreen is allowed once and in this circumstance, patients are not required to go back on prior medication (low dose ICS with or without controller) for the full 4 weeks duration and the rescreen can be scheduled at site's convenience. In this case all assessments must be done according to protocol's requirements.\n8. FEV1 bronchodilator responsiveness testing using up to 4 puffs of SABA (up to 400μg salbutamol or 360μg albuterol) at Run-in Visit (Visit 20): increase \\> and/or = 12% (performed according to ATS/ERS 2019 guidelines). All patients must perform a bronchodilator responsiveness test at start of Run-in. If responsiveness is not demonstrated at Run-in, it may be repeated once on the same day. If responsiveness is still not demonstrated after repeat, documentation of historical reversibility is accepted. If not available patients must be screen failed. Spacers may be used for bronchodilator responsiveness testing.\n9. Demonstrate acceptable inhaler use technique with Breezhaler® at randomization, as well as acceptable use of other study devices and be able to complete spirometry procedures.\n10. A parent/legal guardian is to complete all e-Diary entries and attend all clinic visits with the patient. It is recommended, if possible, to have the same parent/legal guardian to complete the e-diary entries and attend clinic visits with the patient.\n11. Have a documented negative COVID-19 test (validated PCR or antigenic test)) within 3 days prior to randomization visit.\n12. For optional Pharmacokinetics (PK) analysis: Participants willing to participate in the optional PK analysis will need to weigh at least 25 kg at screening.\n\nExclusion Criteria Participants meeting any of the following criteria are not eligible for inclusion in this study.\n\n1. Prior intubation for asthma.\n2. Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours).\n3. Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period.\n4. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.\n5. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.\n6. History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and/or urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement.\n\n   * Evidence of urinary obstruction, or difficulty in voiding\n   * Evidence of congenital renal abnormalities with an established effect on renal function\n   * Calculated eGFR \\<60 mL/min/1.73m2 using the Bedside Schwartz formula.\n7. Patients who have had a respiratory tract infection as determined by the investigator within 4 weeks prior to Visit 1, or between Visit 1 and Visit 30.\n\n   Patients may be re-screened once, 4 weeks after recovery from their respiratory tract infection.\n8. Any chronic condition of the respiratory tract which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.\n9. Patient with evidence upon visual inspection (laboratory culture not required) of clinically significant (upon the opinion of the investigator) oropharyngeal candidiasis at Visit 30 or earlier, with or without treatment, Patients may be rescreened once their candidiasis has been treated and has resolved.\n10. History of chronic lung disease other than asthma such as and not limited to, sarcoidosis interstitial lung disease, cystic fibrosis, mycobacterial or other infection (including active tuberculosis or atypical mycobacterial disease), chronic obstructive pulmonary disease (COPD) and asthma/COPD overlap syndrome (ACOS).\n11. Patients with a history of long QT syndrome or whose corrected QT interval (QTc) measured at start of Run-in or Baseline (Fridericia method) is prolonged (≥ 450 msec for boys and girls) and confirmed by a central assessor (these patients should not be rescreened).\n12. Subjects who have a clinically significant ECG abnormality reported before Visit 30 (End of Run-in).\n13. Subjects who have a clinically significant abnormal laboratory values as per investigator judgement or abnormal liver chemistry results (i.e. ALT, AST, total bilirubin, alkaline phosphatase, GGT and albumin above the upper limit of normal) reported before Visit 30 (End of Run-in).\n14. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the subject in case of participation in the study.\n15. Subjects who, in the opinion of the investigator, are not able to be compliant with study treatment or who have any medical or mental disorder, situation, or diagnosis which could interfere with the proper completion of the protocol requirements or risk the subject's safety while participating in the study.\n16. Subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.\n17. Patients who have been treated with long-acting theophylline preparations within four weeks prior to Screening and/or during the screening period or who have been treated with short-acting theophylline preparations within two weeks prior to Screening.\n18. Patients who have been treated with non-approved and according to international guidelines not recommended experimental drugs for routine asthma therapy within four weeks prior to Visit 1 and/or during the screening period.\n19. Use of Long-Acting Muscarinic Antagonist (LAMA) as maintenance treatment within 3 months prior to Screening.\n20. Evidence of unstable disease within 4 weeks prior to Screening (Visit 1) that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.\n21. History of hypersensitivity to any ingredients of the study drugs including fluticasone propionate, indacaterol acetate, mometasone furoate, budesonide and salmeterol/albuterol or drug of similar chemical classes. This includes any known hypersensitivity or intolerance to the excipients, including lactose.\n22. Patients with Type I diabetes or uncontrolled Type II diabetes either by HBA1c\\>8 or as per judgement of investigator prior to End of Run-In (Visit 30)\n23. Patients receiving any asthma-related or non asthma-related prohibited medications as specified in the protocol.\n24. Immunotherapy or desensitization for allergies started within 3 months prior to Visit 20, or where the maintenance dose is expected to change during the study.\n25. Female patients of childbearing potential defined as all females physiologically capable of becoming pregnant (including female pediatric patients who are menarchal or who become menarchal during the study)) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria.\n\nEffective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps). For UK: with spermicidal foam/gel/film/cream/ vaginal suppository\n* Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \\<1%), for example hormone vaginal ring or transdermal hormone contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) If using oral contraception females should have been stable on the same pill for a minimum of 3 months before taking investigational drug. The decision on the contraceptive method should be reviewed at least every 3 months to evaluate the individual need and compatibility of the method chosen.","locations":[{"facility":"Novartis Investigative Site","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Mendoza","state":"Mendoza Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Graz","state":"","country":"Austria","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Salzburg","state":"","country":"Austria","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sankt 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FEV1"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["caba-argentina","mendoza-argentina","rosario-argentina","graz-austria","salzburg-austria","sankt-p-lten-austria","bras-lia-brazil","porto-alegre-brazil","sorocaba-brazil","rousse-bulgaria","sevlievo-bulgaria","bucaramanga-colombia","ibague-colombia","cali-colombia","plzen-bory-czechia","prague-czechia","athens-greece","cha-d-ri-greece","heraklion-crete-greece","p-trai-greece","thessaloniki-greece","guatemala-city-guatemala","budapest-hungary","g-d-ll-hungary","szeged-hungary","szigetv-r-hungary","brescia-italy","catania-italy","florence-italy","pavia-italy","roma-italy","naples-italy","guadalajara-mexico","san-juan-del-r-o-mexico","villahermosa-mexico","quer-taro-mexico","panama-city-panama","lisbon-portugal","porto-portugal","timi-oara-romania","bucharest-romania","bloemfontein-south-africa","pretoria-south-africa","raslouw-centurion-south-africa","cape-town-south-africa","george-south-africa","centurion-south-africa","esplugues-spain","sabadell-spain","barcelona-spain","c-rdoba-spain","madrid-spain","m-laga-spain","haiphong-vietnam","hanoi-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 3: testing QMF149 for Asthma","inPlainEnglish":"This study wants to measure the superiority in terms of how well it works and measure the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma. * The study duration will be up to 37 weeks including an investigational treatment duration of 12 weeks and a comparator treatment duration of 12 weeks.","whoItsFor":["Ages 6 Years to 11 Years","Male or female children ≥ 6 years and \\<12 years in age at randomization","Parents/legal guardian must be willing and able to attend study visits and assist the child with the procedures outlined in the protocol (e.g. compliance with taking study medication and completing the diary) ((≥ 70% during the last 14 days of the Run-in period))","Confirmed/documented diagnosis of asthma, as defined by national or international asthma guidelines for at least 12 months prior to study enrollment","All patients must be symptomatic at randomization (Visit 30), as defined by ACQ-IA≥1.5. Patients previously on low dose ICS may be included for run-in only if ACQ-IA score ≥1.5 at Visit 20 and will be randomly assigned if ACQ-IA score ≥1.5 at Visit 30","Patients previously on low dose ICS with one controller may do the wash out of the controller before the start of run-in and be included for run-in only if ACQ-IA score ≥ 1 and \\<1.5 at Visit 20 and will be randomly assigned if ACQ-IA score ≥1.5 at Visit 30","Pre-Bronchodilator FEV1 ≥50% of predicted normal at start of Run-in (Visit 20) and end of Run-in (Visit 30)","Withholding period of bronchodilators prior to spirometry at all time:"],"whoShouldSkip":["Participants meeting any of the following criteria are not eligible for inclusion in this study","Prior intubation for asthma","Patients who have had a severe asthma exacerbation requiring in the previous month either systemic steroids or hospitalization due to asthma (\\>24h) or emergency room visit (≤24 hours)","Subjects receiving any medications in the classes specified in Table 6 6 unless they undergo the required washout period prior to Treatment Visit (Day 1) and follow the adjustment through the treatment period","Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer","History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases","History or presence of impaired renal function as indicated by clinically significant abnormal creatinine or blood urea nitrogen (BUN) and/or urea values, or abnormal urinary constituents (e.g. albuminuria) according to investigator's judgement"],"whatHappens":"If you join, the listed intervention(s) are QMF149, or Budesonide. The registry lists allocation as randomized. This study wants to measure the superiority in terms of how well it works and measure the safety of QMF149 (indacaterol (acetate) / mometasone (furoate)) compared to budesonide in children from 6 to less than 12 years of age with asthma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 200 people at 59 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.338Z"},{"nctId":"NCT05564377","title":"Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial","officialTitle":"Molecular Analysis for Combination Therapy Choice (ComboMATCH)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.","conditions":["Advanced Malignant Solid Neoplasm","Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Malignant Solid Neoplasm","Malignant Female Reproductive System Neoplasm","Metastatic HER2-Negative Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Recurrent Endometrial Carcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Unresectable HER2-Negative Breast Carcinoma","Unresectable Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"DRUG","name":"Alpelisib"},{"type":"DRUG","name":"Binimetinib"},{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"PROCEDURE","name":"Bone Scan"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Fluorouracil"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Ipatasertib"},{"type":"DRUG","name":"Leucovorin"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"PROCEDURE","name":"Mutation Carrier Screening"},{"type":"DRUG","name":"Neratinib Maleate"},{"type":"DRUG","name":"Nilotinib Hydrochloride Monohydrate"},{"type":"DRUG","name":"Olaparib"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Palbociclib"},{"type":"BIOLOGICAL","name":"Panitumumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"DRUG","name":"Selumetinib Sulfate"},{"type":"DRUG","name":"Sotorasib"}],"enrollment":2900,"startDate":"2023-04-07","completionDate":"2030-07-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \\>= 50% or Karnofsky performance status of \\>= 50%\n* Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider\n* All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL)\n* Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria:\n\n  * Patients must have progressed on at least one line of standard systemic therapy OR\n  * Patients whose disease has no standard treatment that has been shown to prolong overall survival\n* Patient must meet one of the following requirements:\n\n  * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR\n  * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial\n    * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \\[CR\\] or partial response \\[PR\\]) to any intervening therapy after collection of the tissue\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR\n  * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria:\n\n    * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available\n  * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only\n* NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Alabama Mitchell Cancer Institute","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTCA at Western Regional Medical Center","city":"Goodyear","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kingman Regional Medical Center","city":"Kingman","state":"Arizona","country":"United 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The registry lists allocation as randomized. This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 2,900 people at 484 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.704Z"},{"nctId":"NCT05567198","title":"Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","officialTitle":"Efficacy of Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosphamide as Determined by Questionnaires","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","sponsorClass":"NIH","summary":"Background:\n\nSystemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC). But CYC can damage a woman s ovaries; it may cause infertility. A drug called GnRHa is sometimes given to protect the ovaries during CYC therapy. But no one really knows how effective GnRHa treatment is. This natural history survey will compare women who received GnRHa during CYC therapy with those who did not.\n\nObjective:\n\nTo find out whether GnRHa can help protect women s ovaries during CYC.\n\nEligibility:\n\nWomen under age 40 years starting CYC treatment with or without GnRHa.\n\nDesign:\n\nThis study will do 2 things: It will conduct patient surveys. It will collect data from medical records.\n\nParticipants will complete a one-time survey. They will answer questions about their menstrual cycle. They will be asked about their history of pregnancy or infertility.\n\nParticipants can take the survey in 4 ways:\n\nOn paper, sent through the mail.\n\nOnline, in a secure web page managed by the NIH.\n\nBy phone.\n\nIn person, during a routine visit to the NIH clinic.\n\nThe survey will take about 30 minutes.\n\nParticipants medical records will be reviewed. Researchers will look for data about the participants SLE disease. This may include their symptoms and the results of their blood tests. It may also include the details of prior treatments.\n\nResearchers will also collect data about participants reproductive history. This may include their personal or family history of infertility. It may include any fertility treatments and any sexually transmitted infections.","conditions":["Systemic Lupus Erythematosus (Sle)","Primary Ovarian Insufficiency (Poi)"],"keywords":["Primary Ovarian Insufficiency (Poi)","Nephritis","Neuro-Psychiatric Lupus","Anti-Mullerian Hormone (Amh)","Natural History"],"interventions":[],"enrollment":100,"startDate":"2023-03-03","completionDate":"2027-05-31","sex":"FEMALE","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* ELIGIBILITY CRITERIA:\n* INCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nSLE females \\<40 years at the beginning of CYC treatment without GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 1: SLE patients receiving CYC alone\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs).\n\n-INCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.\n\nSLE females \\<40 years at the beginning of CYC treatment with GnRH-a cotreatment.\n\n-EXCLUSION CRITERIA: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months.\n\nFemales \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated STIs.\n\n-Group: Control subjects.\n\nAge-matched female SLE patients without a history of reproductive disorders, infertility, or untreated STIs, who have not received CYC either with or without GnRH-a.","locations":[{"facility":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarfaraz A Hasni, M.D.","phone":"(301) 451-1599","email":"hasnisa@mail.nih.gov"}],"primaryOutcomes":["POI"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Gonadotropin-releasing Hormone Agonist (GnRHa) in Ovarian Preservation in SLE Subjects Receiving Cyclophosp…","inPlainEnglish":"Background: Systemic lupus erythematosus (SLE) is a disease that affects females nine times more often than males. People with SLE are often treated with cyclophosphamide (CYC).","whoItsFor":["Ages 18 Years to 120 Years","Women only","ELIGIBILITY CRITERIA:","Group 1: SLE patients receiving CYC alone","SLE females \\<40 years at the beginning of CYC treatment without GnRH-a cotreatment"],"whoShouldSkip":["Group 1: SLE patients receiving CYC alone","Females \\>40 years at the beginning of CYC treatment; any females with a prior history of reproductive disorders, infertility, or untreated sexually transmitted infections (STIs)","who can join: Group 2: SLE patients receiving both CYC and leuprolide acetate (GnRH-a). Leuprolide acetate was injected at a dose of either 3.75 mg/month or 11.25mg/every 3 months","SLE females \\<40 years at the beginning of CYC treatment with GnRH-a cotreatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.266Z"},{"nctId":"NCT05579366","title":"Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)","officialTitle":"Phase 1/2 Study of Rina-S in Patients With Locally Advanced and/or Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Genmab","sponsorClass":"INDUSTRY","summary":"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.\n\nParticipants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).","conditions":["High Grade Epithelial Ovarian Cancer","High Grade Serous Ovarian Cancer","Primary Peritoneal Carcinoma","Fallopian Tube Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer (NSCLC)","Mesothelioma","Breast Adenocarcinoma","Triple Negative Breast Cancer","Hormone Receptor-positive/Her2 Negative Breast Cancer","Platinum-resistant Ovarian Cancer (PROC)","Platinum Sensitive Ovarian Cancer (PSOC)","Primary Refractory Ovarian Cancer","Uterine Cancer","Cervical Cancer"],"keywords":["antibody-drug conjugate","folate receptor alpha","folate receptor","solid tumor","ovarian cancer","primary peritoneal carcinoma","fallopian tube cancer","endometrial cancer","non-small cell lung cancer","mesothelioma","breast cancer","triple negative breast cancer","hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer","topoisomerase I inhibitor","PROC","epidermal growth factor receptor (EGFR)-mutated NSCLC","pMMR"],"interventions":[{"type":"DRUG","name":"Rina-S"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Erythromycin"},{"type":"DRUG","name":"Itraconazole"}],"enrollment":952,"startDate":"2022-12-07","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPart A and B:\n\n* Histologically or cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer (Part A), EGFR-mutated NSCLC (Part B), breast cancer (hormone receptor positive, HER2-negative and triple-negative) (Part A), mesothelioma or cervical cancer (Part B).\n* Previously received therapies known to confer clinical benefit.\n* Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline.\n\nPart C, E, and H:\n\nParticipants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below.\n\n* High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)\n* Participants must have received up to 3 prior lines of therapy. Participants may have had up to to 4 prior lines of therapy are allowed if MIRV is locally approved and was used as the last line of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.\n* Participants must have platinum-resistant ovarian cancer.\n* Participants must have received prior bevacizumab or approved biosimilar.\n* Participants with known or suspected deleterious germline or somatic BRCA mutations (as determined by Food and Drug Administration \\[FDA\\]-approved test in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified laboratory; or locally approved equivalent) and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment.\n* Measurable disease per the RECIST v1.1 at baseline.\n\nPart D:\n\nCohort D1:\n\n* Participants must have platinum-sensitive ovarian cancer.\n* Participants must have received 1 to 3 prior lines of therapy.\n\nCohort D2:\n\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Participants with primary platinum-refractory ovarian cancer must have received ≤2 prior lines of therapy. Primary platinum-refractory ovarian cancer is defined as a lack of response or by progression within 91 days after completing front-line platinum containing therapy.\n* Participants must have received 1 to 3 prior lines of therapy for platinum-resistant ovarian cancer (PROC), and up to 4 prior lines of therapy for platinum-sensitive ovarian cancer (PSOC). Prior treatments may have included bevacizumab, PARP inhibitor, and MIRV.\n\n  * Participants with PSOC must have disease progression on or after maintenance treatment, or at least 6 months (\\>183 days) or more from the last dose of platinum-based therapy.\n\nCohort D3:\n\n• Endometrial cancer (any subtype excluding sarcoma).\n\nCohort D4:\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nCohort D5\n\n• Primary advanced or recurrent endometrial cancer (any subtype excluding sarcoma and neuroendocrine tumors).\n\nPart F and G:\n\n* Participants must have histologically or cytologically confirmed EC.\n* Recurrent progressive EC (any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received 1 to 3 prior lines of therapy, and must have progressed radiographically on or after their most recent line of therapy:\n* Participants must have received prior platinum-based chemotherapy and a programmed death-ligand 1 (PD-\\[L\\])1 inhibitor.\n* Participants who progress \\>12 months after completion of prior adjuvant or neoadjuvant platinum-based chemotherapy must receive 1 additional cytotoxic systemic treatment prior to enrollment in this study.\n* Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart I:\n\n* Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer (excluding clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies or low grade/borderline ovarian tumors).\n* Participants must have platinum sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart J:\n\n* Participants must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart K:\n\n* Participants must have histologically or cytologically confirmed metastatic or unresectable ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element).\n* Participants must have primary platinum-refractory, platinum-resistant, or platinum-sensitive ovarian cancer.\n* Measurable disease per the RECIST Version 1.1 at baseline.\n\nPart L:\n\n* Participants must have a histologically or cytologically confirmed metastatic or unresectable solid malignancy. Participants must have previously received all therapies known to confer clinical benefit (unless ineligible to receive or refused to receive or therapy is unavailable in the region). If a standard-of-care therapy is available that has not been administered, the reason that the therapy is not appropriate must be documented.\n* Participants must either have ovarian cancer (must have high grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer including serous, endometrioid, and clear cell carcinomas, and excluding mucinous, low grade, and those with a sarcomatous or neuroendocrine element), or\n* NSCLC.\n* Age 18 to 65 years (inclusive).\n* An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.\n* Measurable disease per the RECIST version 1.1 at baseline.\n\nExclusion Criteria:\n\n* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n* Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate.\n\nNote: Other protocol-defined inclusion/exclusion may apply.","locations":[{"facility":"USOR HonorHealth","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Arizona Oncology Associates","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego; Moores Cancer Center","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Sansum Clinic","city":"Santa Barbara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Florida Cancer Specialists South","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Florida Cancer Specialists North","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Florida Cancer Specialists East","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University Georgia Cancer Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center (KUMC)","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Maryland Oncology Hematology","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Minnesota Oncology Hematology","city":"Maplewood","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center at Cooper- Two Cooper Plaza","city":"Camden","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center (OSUCCC)- The James Cancer Hospital and Solove Research Institute","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma - Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Oncology Associates of Oregon, P.C.","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Compass Oncology - Rose Quarter","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Alliance Cancer Specialist","city":"Doylestown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny Health Network","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women and Infants Hospital of Rhode Island","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at Tennessee Oncology","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Texas Oncology","city":"Abilene","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Central / South Texas","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Crowley Cancer Research","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Texas Oncology","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast TX","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Texas Oncology Gulf Coast","city":"Woodland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USOR Virginia Oncology Associates","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute","city":"Everett","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer hospital, Chinese Academy of Medical Sciences","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Cancer Hospital","city":"Fujian","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen Memorial Hospital, Sun Yat-sen University","city":"Guangdong","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Second Affiliated Hospital of Zhengzhou University","city":"Henan","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","city":"Hubei","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Second Hospital of Shanxi Medical University","city":"Shanxi","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Cancer Hospital","city":"Shanxi","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liaoning Cancer Hospital & Institute","city":"Shengyang","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Cancer Hospital","city":"Tianjin","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Cancer Hospital","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital - Phase 1","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital - Thoracic Medicine Dept II","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Maternal and Child Health Hospital","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jilin Cancer Hospital","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Obstetrics & Gynecology Hospital of Fudan University","city":"Chengdu","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center - Gynecologic Oncology","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center- Phase 1","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital","city":"Shanghai","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukushima Medical University Hospital","city":"Fukushima","state":"Fukushima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gunma Prefectural Cancer Center","city":"Ōta","state":"Gunma","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo Medical University Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hyogo Cancer Center","city":"Akashi","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Medical University-International Medical Center","city":"Hidaka","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Nagaizumi-chō","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Institute Hospital of JFCR","city":"Koto","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keio University Hospital","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yamagata University Hospital","city":"Yamagata","state":"Yamagata","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea Institute of Radiological and Medical Sciences","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Genmab Trial Information","phone":"+4570202728","email":"clinicaltrials@genmab.com"}],"primaryOutcomes":["Parts A, B, and D - Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability]","Parts A, and D - Number of Participants with Dose Limiting Toxicity (DLT)","Parts C, E, F, G, H, I, and J- Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR, Parts C and F) or Investigator (Part E, G, I, and J) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","Part K (US Participants Only) - Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Findings by Holter","Part L - Peak Plasma Concentration (Cmax) of Rina-S","Part L - Area Under the Plasma Concentration Versus Time Curve (AUC) of Rina-S"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","ovarian-cancer","cervical-cancer","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["phoenix-arizona","tucson-arizona","los-angeles-california","san-diego-california","santa-barbara-california","santa-rosa-california","fort-myers-florida","st-petersburg-florida","west-palm-beach-florida","augusta-georgia","westwood-kansas","rockville-maryland","boston-massachusetts","detroit-michigan","grand-rapids-michigan","maplewood-minnesota","camden-new-jersey","columbus-ohio","oklahoma-city-oklahoma","eugene-oregon","portland-oregon","doylestown-pennsylvania","pittsburgh-pennsylvania","providence-rhode-island","nashville-tennessee","abilene-texas","austin-texas","dallas-texas","fort-worth-texas","tyler-texas","woodland-texas","west-valley-city-utah","fairfax-virginia","norfolk-virginia","everett-washington","beijing-china","fujian-china","guangdong-china","henan-china","hubei-china","shanxi-china","shengyang-china","tianjin-china","chongqing-china","changsha-china","nanchang-china","changchun-china","chengdu-china","shanghai-china","hangzhou-china","fukushima-japan","ta-japan","sapporo-japan","akashi-japan","hidaka-japan","nagaizumi-ch-japan","koto-japan","shinjuku-ku-japan","yamagata-japan","seoul-south-korea"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Rina-S for High Grade Epithelial Ovarian Cancer","inPlainEnglish":"This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).","whoItsFor":["Ages 18 Years to any","Previously received therapies known to confer clinical benefit","Measurable disease per RECIST v1.1 for all tumor types other than pleural mesothelioma which will use mRECIST v1.1 at baseline","Participants must have histologically or cytologically confirmed metastatic or unresectable epithelial ovarian cancer as specified below","High grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (excluding endometrioid, clear cell carcinomas, mucinous, low grade, and those with a sarcomatous or neuroendocrine element)","Participants must have platinum-resistant ovarian cancer","Participants must have received prior bevacizumab or approved biosimilar","Measurable disease per the RECIST v1.1 at baseline"],"whoShouldSkip":["History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids within the past 2 years, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening","Prior therapy with a topoisomerase 1 inhibitor-based antibody drug conjugate","Note: Other protocol-defined inclusion/exclusion may apply"],"whatHappens":"If you join, the listed intervention(s) are Rina-S, Carboplatin, or Bevacizumab. The registry lists allocation as randomized. This study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 952 people at 67 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.696Z"},{"nctId":"NCT05580458","title":"Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population","officialTitle":"Phase 1/2 Open-label Trial of Safety and Zoster Immunogenicity Evaluation for People With HIV With CD4 Counts Under and Above 300 and Healthy Volunteers Following Shingrix Vaccination (ZEUS)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nShingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18. Researchers want to learn more about how people with HIV respond to Shingrix.\n\nObjective:\n\nTo learn how Shingrix affects the immune response in people with HIV.\n\nEligibility:\n\nPeople aged 18 years and older with HIV. Healthy people aged 50 years or older are also needed.\n\nDesign:\n\nParticipants will have at least 4 clinic visits in 1 year.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests.\n\nAt their first visit, participants will receive Shingrix as a shot in the upper arm. They will have a rectal swab; a cotton swab will be inserted into the rectum and rotated gently to collect bacteria.\n\nParticipants will receive a second shot of Shingrix 2 months after the first one. They will visit the clinic again 3 and 12 months after the first shot.\n\nParticipants will receive a 28-day memory tool. They will write down their symptoms between clinic visits. They will have up to 4 phone calls to talk about side effects of the shot.\n\nParticipants may undergo apheresis: They will lie still while blood is drawn from a needle in one arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be given back through a second needle in their other arm.","conditions":["Herpes Zoster"],"keywords":["HERPES ZOSTER","Shingrix Vaccine"],"interventions":[{"type":"BIOLOGICAL","name":"Shingrix"}],"enrollment":225,"startDate":"2023-03-13","completionDate":"2027-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nGeneral Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be eligible for study participation:\n\n* Able to provide informed consent.\n* Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 3. Acceptable methods of contraception include the following:\n\n  * Hormonal contraception.\n  * Male or female condom.\n  * Diaphragm or cervical cap with a spermicide.\n  * Intrauterine device.\n* Has a primary care provider.\n\nAdditional Inclusion Criteria for People with HIV:\n\n* PWH must also meet all the following criteria to be eligible for study participation:\n* \\>= 18 years of age.\n* Seropositive for HIV-1 (documented or confirmed at screening).\n* Documented viral load \\< 100 copies/mL within 90 days of screening and documented viral suppression defined as viral load consistently \\<100 copies/mL with at least one documented viral load \\< 40 copies/mL within 12 months prior to screening.\n* Currently on a stable antiretroviral regimen (minimum of 6 months of a stable ART regimen; changes for side effects, drug interaction, or convenience allowed), or is an elite controller (maintains undetectable viral loads in the absence of any treatment for a period of 12 months prior to screening visit).\n* No active/uncontrolled opportunistic infections (patients on chronic maintenance therapy would be considered as controlled).\n\nAdditional Inclusion Criteria for Healthy Volunteers:\n\nHealthy volunteers must also meet all of the following criteria to be eligible for study participation:\n\n* \\>= 50 years of age.\n* No uncontrolled chronic medical issues that per the discretion of the PI or designee would compromise the safety of the research participant.\n* No underlying immunodeficiencies (including negative HIV test at screening).\n\nEXCLUSION CRITERIA:\n\nIndividuals meeting any of the following criteria will be excluded from study participation:\n\n* Previous receipt of Shingrix vaccine at any time.\n* Receipt of Zostavax within the past 12 months.\n* History of severe allergic reaction to any component of Shingrix.\n* Diagnosed varicella or herpes zoster episode within the past 1 month. Subject will be eligible for SHINGRIX vaccine once symptoms of herpes zoster episode have resolved.\n* Immunocompromised (other than HIV for the PWH cohort) within the past 6 months (eg, due to a malignancy other than skin cancer).\n* Current moderate or severe acute illness (ie, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the principal investigator, would make the subject unsuitable for the study.\n* Pregnancy or breastfeeding.\n* Receipt of an investigational agent, investigational vaccine, or licensed live virus vaccine within 30 days prior to screening.\n* Planned receipt of any vaccine (investigational or ACIP-recommended) between months 0 and 2 except for the tetanus, diphtheria, and pertussis vaccine \\[TDaP\\], Pneumovax, inactivated influenza vaccines, and COVID-19 vaccine which may be given at least 8 days before and/or at least 14 days after each study agent injection (at month 0/month 2).\n* Administration of immunoglobulins or any blood products within 90 days preceding the first dose of vaccine or planned administration during the study period.\n* Chronic administration (\\>= 15 consecutive days) of immunosuppressive or other immune-modifying drugs within 6 months before screening. (Prednisone \\< 20 mg/day or equivalent, corticosteroid nasal spray or inhaler, and topical steroids are not exclusionary).\n* Uncontrolled psychiatric disease per physician evaluation, current substance use, or inappropriate conduct unsuitable for a research study.\n* Any condition that could compromise, in the investigator's opinion, the participant's safety or the study outcomes.\n\nParticipants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, race, ethnicity, socioeconomic status, etc, except for age.\n\nMedical record review may be used for determining eligibility. If a clinical laboratory evaluation is available for review at the screening timepoint, but was obtained prior to protocol consent, the laboratory test does not have to be repeated for the purposes of confirming eligibility under the protocol.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maura M Manion, M.D.","phone":"(301) 312-2103","email":"maura.manion@nih.gov"}],"primaryOutcomes":["Fold change of anti-gE antibody concentrations evaluated regularly through the end of study (months 3 and 12) by CD4 count (< 300 and >= 300)"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Shingrix for Herpes Zoster","inPlainEnglish":"Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox. Shingrix is a vaccine approved to prevent shingles in healthy adults over age 50 and in immunocompromised adults over age 18.","whoItsFor":["Ages 18 Years to any","General who can join:","Individuals must meet all of the following criteria to be eligible for study participation:","Participants of childbearing potential must agree to use at least 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy, beginning at screening through month 3. Acceptable methods of contraception include the following:","Hormonal contraception","Male or female condom","Diaphragm or cervical cap with a spermicide","Intrauterine device"],"whoShouldSkip":["Individuals meeting any of the following criteria will be excluded from study participation:","Previous receipt of Shingrix vaccine at any time","Receipt of Zostavax within the past 12 months","History of severe allergic reaction to any component of Shingrix","Diagnosed varicella or herpes zoster episode within the past 1 month. Subject will be eligible for SHINGRIX vaccine once symptoms of herpes zoster episode have resolved","Immunocompromised (other than HIV for the PWH cohort) within the past 6 months (eg, due to a malignancy other than skin cancer)","Current moderate or severe acute illness (ie, febrile illness, seizure, myocardial infarction, cerebrovascular accident, pulmonary embolism) that in the opinion of the principal investigator, would make the subject unsuitable for the study"],"whatHappens":"If you join, the listed intervention(s) are Shingrix. The registry lists allocation as na. Background: Shingles is a painful, blistering rash caused by the same virus that causes chickenpox.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 225 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.529Z"},{"nctId":"NCT05583617","title":"A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma","officialTitle":"A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cevostamab"},{"type":"DRUG","name":"Lenalidomide"},{"type":"DRUG","name":"Tocilizumab"},{"type":"DRUG","name":"Iberdomide"},{"type":"DRUG","name":"Dexamethasone"}],"enrollment":200,"startDate":"2023-11-14","completionDate":"2028-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with MM per International Myeloma Working Group (IMWG) criteria\n* Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2\n* Resolution of AEs from prior anti-cancer therapy to Grade \\<=1\n* Agreement to undergo scheduled assessments and procedures\n\nAdditional Inclusion Criteria for SS2:\n\n* Completion of planned induction therapy and achievement of at least a partial response (PR)\n* Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease\n* Cytogenetic high-risk features at diagnosis\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest\n* Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception\n* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm\n\nAdditional Inclusion Criteria for SS4:\n\n* Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R/R MM for whom no suitable SOC therapy options are available\n\nExclusion Criteria:\n\n* Inability to comply with protocol-mandated hospitalization and procedures\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of other malignancy within 2 years prior to screening\n* Current or past history of central nervous system (CNS) disease\n* Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event\n* Symptomatic active pulmonary disease or requiring supplemental oxygen\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection\n* Acute or chronic hepatitis C virus (HCV) infection\n* Known history of HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study\n* Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results\n\nAdditional Exclusion Criteria for SS2:\n\n* Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs\n* Harbor lesions at proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare\n* Prior treatment with any investigational medicinal product, systemic cancer therapy, or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks, whichever is shorter\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment\n* History of erythema multiforme, Grade \\>=3 rash, or blistering following prior treatment with immunomodulatory derivatives\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment Exlcusion Criteria Applicable to SS2 and SS4\n* History of autoimmune disease\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* Received a cumulative dose of corticosteroids equivalent to \\>=140 mg of prednisone within the 14-day period before the first dose of the study drug (does not include pretreatment medication)\n* Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment.\n* Positive and quantifiable EBV PCR or CMV PCR prior to first study treatment\n\nAdditional Exclusion Criteria for SS4:\n\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies within 5 half-lives or 12 weeks before starting pre-phase\n* History of anaphylaxis or hypersensitivity, including \\>=Grade 3 rash, during prior treatment with IMiDs, dexamethasone, any CELMoDs, or the excipients contained in the formulations\n* Known anaphylaxis, allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies (or recombinant antibody-related fusion proteins), or human proteins, CRBN modulating agents or their excipients, or known sensitivity to mammalian-derived products\n* Administration of strong CYP3A modulators; administration of proton-pump inhibitors within 2 weeks of starting study treatment\n* Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment\n* Concurrent administration of a strong inhibitor, modulator or inducer of cytochrome P450 (CYP3A4/5) (including within 14 days of initiating study treatment)\n* History of malignancies, other than MM, unless the subject has been free of the disease for \\>=5 years\n* Peripheral neuropathy \\>Grade 2\n* Prior treatment with cevostamab or another agent targeting FcRH5 or iberdomide\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment\n* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms\n* Treatment with systemic immunosuppressive medications\n* Prior treatment with CAR T-cell therapy (autologous or allogeneic) within 12 weeks before starting pre-phase\n* Autologous SCT within 100 days prior to starting pre-phase\n* Prior allogeneic SCT\n* Plasmacytoma in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare","locations":[{"facility":"Prince of Wales Hospital","city":"Randwick","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Vincent's Hospital Melbourne","city":"Fitzroy","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Lyon Sud - Service Hématologie","city":"Pierre-Bénite","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"IUCT Oncopole","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Bretonneau","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"IGR","city":"Villejuif","state":"","country":"France","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Leipzig - Klinik und Poliklinik für Hämatologie","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne","city":"Gda?sk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji z Warminsko-Mazurskim Centrum Onkologii w Olsztynie","city":"Olsztyn","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny w Poznaniu","city":"Późna","state":"","country":"Poland","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Jimenez Diaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CO43923 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Stage 1: Percentage of Participants with Adverse Events (AEs)","Stage 2: Objective Response Rate (ORR)","Stage 2: Complete Response (CR) or Stringent Complete Response (sCR) Rate","Stage 2: Rate of Very Good Partial Response (VGPR) or Better","Stage 2: Progression-free Survival (PFS)","Stage 2: Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["randwick-australia","fitzroy-australia","pierre-b-nite-france","toulouse-france","tours-france","villejuif-france","hamburg-germany","leipzig-germany","gda-sk-poland","olsztyn-poland","p-na-poland","seoul-south-korea","badalona-spain","madrid-spain","valencia-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Cevostamab for Multiple Myeloma","inPlainEnglish":"CO43923 is a platform study that will measure the safety, how well it works, and pharmacokinetics (PK) of multiple treatment combinations, as this drug alone or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available.","whoItsFor":["Ages 18 Years to any","Diagnosed with MM per International Myeloma Working Group (IMWG) criteria","Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2","Resolution of AEs from prior anti-cancer therapy to Grade \\<=1","Agreement to undergo scheduled assessments and procedures","Additional who can join for SS2:","Completion of planned induction therapy and achievement of at least a partial response (PR)","Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease"],"whoShouldSkip":["Inability to comply with protocol-mandated hospitalization and procedures","History of confirmed progressive multifocal leukoencephalopathy","History of other malignancy within 2 years prior to screening","Current or past history of central nervous system (CNS) disease","Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event","Symptomatic active pulmonary disease or requiring supplemental oxygen","Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment"],"whatHappens":"If you join, the listed intervention(s) are Cevostamab, Lenalidomide, or Tocilizumab. The registry lists allocation as randomized. CO43923 is a platform study that will measure the safety, how well it works, and pharmacokinetics (PK) of multiple treatment combinations, as this drug alone or in combination, in participants with multiple myeloma (MM).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.499Z"},{"nctId":"NCT05583773","title":"SHengXIaN-QuYu DEcoction in Heart Failure With Reduced and Mildly Reduced Ejection Fraction","officialTitle":"Effects of \"ShengXian-QuYu Decoction\" on Quality of Life, Symptoms, and Biomarkers in Heart Failure Patients With Reduced and Mildly Reduced Ejection Fraction: a Pragmatic, Nationwide, Multicenter, Parallel Group, Randomized, Double-Blind, Placebo-Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"China-Japan Friendship Hospital","sponsorClass":"OTHER","summary":"The purpose of this study is to conduct a multicenter, randomized clinical trial to evaluate the effect of \"ShengXian-QuYu Decoction\" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.","conditions":["Heart Failure"],"keywords":["ShengXian-QuYu Decoction","Heart failure with reduced ejection fraction","Heart failure with mildly reduced ejection fraction","Quality of life"],"interventions":[{"type":"DRUG","name":"ShengXian-QuYu Decoction"},{"type":"OTHER","name":"Placebo"}],"enrollment":336,"startDate":"2023-03-29","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female, aged ≥18 years at the time of consent.\n2. Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV).\n3. LVEF \\<50%.\n4. NT-proBNP \\>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment.\n5. Provision of signed informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n1. Current acute decompensated HF or hospitalization due to decompensated HF, ACS, stroke or transient ischemic attack (TIA), coronary revascularization (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]) or valvular repair/replacement, or other major cardiovascular surgery within 4 weeks prior to enrolment.\n2. Uncontrolled severe arrhythmia.\n3. Planned to undergo heart transplantation or device implantation.\n4. Hepatic impairment aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\] \\>3x the upper limit of normal \\[ULN\\]; or total bilirubin \\>2x ULN at time of enrolment).\n5. Severe infection.\n6. eGFR \\<30 mL/min/1.73 m\\^2 by CKD-EPI.\n7. Active malignancy requiring treatment at the time of visit 1.\n8. Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding.\n9. Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement.\n10. Systolic blood pressure \\< 90 mmHg, or systolic blood pressure ≥ 180 mmHg, or diastolic blood pressure ≥ 110 mmHg on 2 consecutive measurements.\n11. Heart failure due to infiltrative cardiomyopathies(cardiac amyloidosis, etc.), fulminant myocarditis, constrictive pericarditis.\n12. Participation in another clinical study.\n13. Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.","locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Fengtai Hospital of Integrated Traditional Chinese and Western Medicine","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dongcheng District First People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dongfang Hospital Affiliated to Beijing University of Chinese Medicine","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huairou District Traditional Chinese Medicine Hospital of Beijing","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Changping Nankou Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changping District Traditional Chinese Medicine Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tang County Hospital of Traditional Chinese Medicine","city":"Baoding","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Funing Hospital of Traditional Chinese Medicine","city":"Qinhuangdao","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gongyi City Public Hospital of TCM","city":"Gongyi","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yangzhou Hospital of Traditional Chinese Medicine","city":"Yangzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jining Hospital of Traditional Chinese Medicine","city":"Jining","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Qingdao University","city":"Qingdao","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Changzhi Institute of Traditional Chinese Medicine","city":"Changzhi","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhi Medical College Affiliated Heji Hospital","city":"Changzhi","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhi Hospital of Traditional Chinese Medicine","city":"Changzhi","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chengdu Integrated TCM and Western Medicine Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jixian Chinese Traditional Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urumqi Hospital of Traditional Chinese Medicine","city":"Ürümqi","state":"Xinjiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changji Hospital of Traditional Chinese Medicine","city":"Changji","state":"Xinjiang Uygur Autonomous Region","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korla Hospital of Traditional Chinese Medicine","city":"Korla","state":"Xinjiang Uygur Autonomous Region","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xinyuan Traditional Chinese Medicine Hospital","city":"Xinyuan","state":"Xinjiang Uygur Autonomous Region","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gulja Hospital of Traditional Chinese Medicine","city":"Yining","state":"Xinjiang Uygur Autonomous Region","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhaosu Hospital of Traditional Chinese Medicine","city":"Zhaosu","state":"Xinjiang Uygur Autonomous Region","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linhai Hospital of Traditional Chinese Medicine","city":"Linhai","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mengxi Yang, Dr.","phone":"+86 15120049452","email":"mxtezuka@163.com"},{"name":"Jiang Liu, Dr.","phone":"+86 19800361320","email":"yzliujiang@163.com"}],"primaryOutcomes":["Change From Baseline in the KCCQ Clinical Summary Score"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["beijing-china","baoding-china","qinhuangdao-china","gongyi-china","yangzhou-china","jining-china","qingdao-china","changzhi-china","chengdu-china","tianjin-china","r-mqi-china","changji-china","korla-china","xinyuan-china","yining-china","zhaosu-china","linhai-china"],"enrichment":{"headline":"Phase 4: testing ShengXian-QuYu Decoction for Heart Failure","inPlainEnglish":"This study wants to conduct a multicenter, randomly assigned clinical trial to measure the effect of \"ShengXian-QuYu Decoction\" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.","whoItsFor":["Ages 18 Years to any","Male or female, aged ≥18 years at the time of consent","Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV)","NT-proBNP \\>600 pg/ml or BNP ≥150 pg/ml (or if hospitalized for heart failure within the previous 12 months, NT-proBNP ≥400 pg/ml or BNP ≥100 pg/ml) at enrolment"],"whoShouldSkip":["Uncontrolled severe arrhythmia","Planned to undergo heart transplantation or device implantation","Hepatic impairment aspartate transaminase \\[AST\\] or alanine transaminase \\[ALT\\] \\>3x the upper limit of normal \\[ULN\\]; or total bilirubin \\>2x ULN at time of enrolment)","eGFR \\<30 mL/min/1.73 m\\^2 by CKD-EPI","Active malignancy requiring treatment at the time of visit 1","Women of child-bearing potential who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding","Any condition outside the CV and renal disease area, such as but not limited to malignancy, with a life expectancy of less than 1 years based on investigator's clinical judgement"],"whatHappens":"If you join, the listed intervention(s) are ShengXian-QuYu Decoction, or Placebo. The registry lists allocation as randomized. This study wants to conduct a multicenter, randomly assigned clinical trial to measure the effect of \"ShengXian-QuYu Decoction\" on quality of life , symptoms, and biomarkers in heart failure patients with reduced and mildly reduced ejection fraction.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 336 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.442Z"},{"nctId":"NCT05588128","title":"Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18FDCFPyL","officialTitle":"A Study of Prospective Monitoring of Subjects With Biochemically Recurrent Prostate Cancer Using 18F-DCFPyL","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nProstate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body. In this natural history study, researchers want to find out if a new radiotracer (18F-DCFPyL) injected before positron emission tomography (PET) imaging can help identify sites in the body with cancer.\n\nObjective:\n\nTo learn more about how 18F-DCFPyL PET/CT scans detect change over time in men with recurrent prostate cancer.\n\nEligibility:\n\nMen aged 18 and older with prostate cancer that returned after treatment.\n\nDesign:\n\nParticipants will be screened with blood tests. They will also have a bone scan and a computed tomography (CT) scans of the chest, abdomen, and pelvis.\n\nParticipants will have an initial study visit. They will have a physical exam and blood tests. They will have a PET/CT scan with 18F-DCFPyL. The radiotracer will be injected into a vein; this will take about 20 seconds. The PET/CT scan will be done 1 to 2 hours later. Participants will lie still on a scanner table while a machine captures images of their body. The scan will take 45 minutes.\n\nParticipants will return for blood tests every 3 months.\n\nParticipants will return for additional scans with 18F-DCFPyL on this schedule:\n\nOnce a year if their previous scan was negative for prostate cancer.\n\nEvery 6 months if their previous scan was positive for prostate cancer.\n\nParticipants may be in the study up to 5 years.\n\n...","conditions":["Prostate Cancer","Biochemically Recurrent"],"keywords":["Cancer Of Prostate","Natural History","Imaging"],"interventions":[{"type":"DRUG","name":"18F-DCFpyL"}],"enrollment":350,"startDate":"2023-03-21","completionDate":"2026-12-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* History of primary treatment for prostate cancer (either surgery or radiation)\n* Serum PSA \\>= 0.50\n* Serum testosterone \\>100\n* Age \\>=18 years\n* Men must agree to use highly effective contraception (surgical sterilization) for 7 days after every study agent administration. Note: abstinence, defined as no heterosexual sexual intercourse when this is in line with the preferred and usual lifestyle of the subject is also acceptable\n* The ability of a participant to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n-Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \\[MRI\\] as clinically indicated).\n\nNOTE: Lymph nodes \\<= 1.5 cm in the shortest dimension are allowed.\n\n* Evidence of bone lesions on Tc99 bone scan\n* Prostatectomy within 1 year before the study intervention\n* Androgen deprivation therapy (ADT) within the 6 months before the study intervention\n* Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy R Hankin, P.A.-C","phone":"(240) 858-3149","email":"amy.hankin@nih.gov"},{"name":"Melissa L Abel, M.D.","phone":"(240) 447-5353","email":"melissa.abel@nih.gov"}],"primaryOutcomes":["Observation of 18F-DCFPyL lesions in BRPC"],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: testing 18F-DCFpyL for Prostate Cancer","inPlainEnglish":"Background: Prostate cancer is the second leading cause of cancer-related death in American men. The disease recurs in up to 50,000 men each year after their early-stage disease was treated; however, at this stage, imaging scans are often unable to find the disease in the body.","whoItsFor":["Ages 18 Years to any","Men only","History of primary treatment for prostate cancer (either surgery or radiation)","Serum testosterone \\>100"],"whoShouldSkip":["Evidence of soft tissue disease on CT scan (or magnetic resonance imaging \\[MRI\\] as clinically indicated)","NOTE: Lymph nodes \\<= 1.5 cm in the shortest dimension are allowed","Evidence of bone lesions on Tc99 bone scan","Prostatectomy within 1 year before the study intervention","Androgen deprivation therapy (ADT) within the 6 months before the study intervention","Systemic therapy for prostate cancer within the 6 months before the study intervention. Other investigational agents, excluding those involving standard of care chemotherapy, received within 6 months prior to the study intervention are allowed"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 350 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.304Z"},{"nctId":"NCT05595200","title":"Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension","officialTitle":"Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Chinese Pulmonary Vascular Disease Research Group","sponsorClass":"OTHER","summary":"The investigators propose a prospective, observational study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated. Adult patients diagnosed with pulmonary hypertension by right heart catheterization are eligible. Recruited patients will undergo an overnight cardiorespiratory study using a Level III portable device before hospital discharge. The cardiorespiratory tracings during sleep will be analyzed and audited by a certified sleep physician. The patients will be divided into two groups based on the apnea-hypopnea index (AHI): OSA (AHI ≥ 5) and non-OSA (AHI\\<5) groups. Hypoxemic parameters such as time percentage spent with oxygen saturation below 90% and nadir oxygen saturation were all collected. Baseline clinical characteristics, such as the Epworth sleepiness scales, were also obtained. The primary endpoint of this study was clinical worsening (CW), defined as the composite event of a reduction in exercise capacity, worsening in World Health Organization functional class, non-elective hospitalization for pulmonary hypertension, or all-cause mortality. Secondary endpoints include individual outcomes of clinical worsening and all-cause mortality.","conditions":["Sleep Apnea","Obstructive Sleep Apnea","Pulmonary Hypertension","Epidemiology","Predictor","Prognosis","Outcomes","Mortality"],"keywords":["Sleep Apnea","Pulmonary Hypertension","Obstructive Sleep Apnea","Hypoxemia","Prognosis","Prevalence","Predictor","Phenotype","Outcome"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Level III portable sleep study"}],"enrollment":480,"startDate":"2020-05-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥18 years old\n* Diagnosed with pulmonary hypertension by right heart catheterization\n\nExclusion Criteria:\n\n* Pregnancy\n* Central sleep apnea\n* Previous treatment for sleep-disordered breathing\n* Unavailable or incomplete sleep data\n* Requiring nocturnal oxygen supplementation","locations":[{"facility":"Center for Respiratory and Pulmonary Vascular Diseases, Fuwai hospital, CAMS & PUMC","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zhihong Liu, M.D., Ph.D","phone":"+861088396590","email":"zhihongliufuwai@163.com"}],"primaryOutcomes":["Clinical worsening"],"hasResults":false,"conditionSlugs":["als","hypertension","sleep-apnea"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Level III portable sleep study for Sleep Apnea","inPlainEnglish":"The investigators propose a prospective, watch-and-measure (no experimental treatment required) study to determine the impact of OSA and associated physiological parameters on clinical outcomes in patients with pulmonary hypertension. The prevalence, phenotypes, and predictors of OSA in the setting of pulmonary hypertension will also be investigated.","whoItsFor":["Ages 18 Years to any","Diagnosed with pulmonary hypertension by right heart catheterization"],"whoShouldSkip":["Central sleep apnea","Previous treatment for sleep-disordered breathing","Unavailable or incomplete sleep data","Requiring nocturnal oxygen supplementation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 480 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.945Z"},{"nctId":"NCT05599347","title":"Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease","officialTitle":"Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Rambam Health Care Campus","sponsorClass":"OTHER","summary":"This is a randomized placebo-controlled trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity","conditions":["Crohn's Disease Relapse","Biological Substance; Adverse Effect"],"keywords":["Crohn's disease","infliximab","adalimumab","azithromycin","immunogenicity"],"interventions":[{"type":"DRUG","name":"Azithromycin Pill"},{"type":"OTHER","name":"Placebo"}],"enrollment":180,"startDate":"2023-04-24","completionDate":"2026-09-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.\n* Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent.\n* Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.\n* Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).\n* Thiopurine and corticosteroid co-therapy will be permitted.\n\nExclusion Criteria:\n\n* Inclusion in another interventional study\n* Patients who cannot provide informed consent and do not have a legal guardian\n* Patients with perianal involvement who are expected to require antibiotic therapy for their disease\n* Patients on chronic antibiotic therapy due to any cause\n* Patients with ongoing fluid collection/abscess either internal or perianal\n* Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device\n* Prolonged QTc interval or conditions leading to additional risk for QT prolongation\n* Chronic kidney disease stage 5 (GFR \\< 10)\n* Crohn's Disease complication requiring surgical treatment\n* Planned/ongoing methotrexate co-therapy\n* Fecal microbiota transplantation within 8 weeks prior to randomization\n* Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study\n* Pregnancy\n* Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy)\n* Patients who received any antibiotic treatment within 4 weeks prior to randomization\n* Re-induction of the same anti-TNF medication\n* Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin","locations":[{"facility":"Rambam Health Care Campus","city":"Haifa","state":"Haifa District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Soroka University Medical Center","city":"Beersheba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bnei Zion","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carmel Medical Center","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolfson Medical Center","city":"Holon","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zvulun","city":"Kiryat Bialik","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Haggai Bar-Yosef, MD","phone":"050-2064878","email":"h_bar-yoseph@rmc.gov.il"},{"name":"Anastasia Weis, MD","phone":"","email":"A_WEIS@rambam.health.gov.il"}],"primaryOutcomes":["Anti-drug antibody development"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["haifa-israel","beersheba-israel","holon-israel","jerusalem-israel","kiryat-bialik-israel","petah-tikva-israel"],"enrichment":{"headline":"Phase 2: testing Azithromycin Pill for Crohn's Disease Relapse","inPlainEnglish":"This is a randomly assigned compared with a dummy treatment trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity","whoItsFor":["Ages 18 Years to any","Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings","Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs)","Thiopurine and corticosteroid co-therapy will be permitted"],"whoShouldSkip":["Inclusion in another treatment study","Patients with perianal involvement who are expected to require antibiotic therapy for their disease","Patients on chronic antibiotic therapy due to any cause","Patients with ongoing fluid collection/abscess either internal or perianal","Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device","Prolonged QTc interval or conditions leading to additional risk for QT prolongation","Chronic kidney disease stage 5 (GFR \\< 10)"],"whatHappens":"If you join, the listed intervention(s) are Azithromycin Pill, or Placebo. The registry lists allocation as randomized. This is a randomly assigned compared with a dummy treatment trial in Crohn's disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.268Z"},{"nctId":"NCT05600764","title":"The Natural History of TRPV4 Neuropathy","officialTitle":"The Natural History of TRPV4 Neuropathy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The goal of this research is to document the natural history of neuropathy in patients with a confirmed genetic mutation in the TRPV4 gene. The investigators are searching for patients willing to participate in a 6-year long study to document the symptoms of TRPV4-associated disease and their progression over time. Participation requires annual study visits at Johns Hopkins for adult and juvenile participants.","conditions":["TRPV4 Gene Mutation"],"keywords":[],"interventions":[],"enrollment":70,"startDate":"2023-12-15","completionDate":"2033-12","sex":"ALL","minAge":"3 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient is aged 3-80 years with a documented mutation in the TRPV4 gene and a clinical phenotype consistent with TRPV4-associated disease (as determined by the investigator) OR\n* The patient has a first-degree relative (parent, child, sibling, half-sibling, aunt, uncle, grandparent, or grandchild) with a documented disease-causing mutation AND a clear link between that family member and the affected patient AND a clinical phenotype consistent with TRPV4-associated disease.\n* Patients with a variant of unknown significance in TRPV4 and a clinical phenotype possibly consistent with TRPV4-associated disease will be eligible for initial enrolment, but continued eligibility will be determined based on whether the observed clinical phenotype is consistent with TRPV4-associated disease (as determined by the investigator).\n* Participant or legal guardian for patients under 18 years of age is capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Medical history of other concomitant neurological disease or clinically significant physical exam/laboratory result that, in the opinion of the investigator, would render the patient being unsuitable for the study.\n* Patients with a TRPV4 variant of unknown significance who are initially enrolled but then deemed to be unlikely to have a phenotype consistent with TRPV4-associated disease will no longer be eligible and their clinical data will be deleted.","locations":[{"facility":"Johns Hopkins","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Betty Hu","phone":"443-250-4699","email":"xhu38@jhu.edu"},{"name":"Simone Thomas","phone":"(410) 614-4188","email":"sthom125@jhmi.edu"}],"primaryOutcomes":["Tracking the severity of overall neuropathy symptoms","Tracking the progression of the disease using functional measures","Tracking the severity of limitations caused by neuropathy","Tracking the severity of disease in pediatric patients"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"The Natural History of TRPV4 Neuropathy","inPlainEnglish":"The goal of this research is to document the natural history of neuropathy in patients with a confirmed genetic mutation in the TRPV4 gene. The investigators are searching for patients willing to participate in a 6-year long study to document the symptoms of TRPV4-associated disease and their progression over time.","whoItsFor":["Ages 3 Years to 80 Years","Patient is aged 3-80 years with a documented mutation in the TRPV4 gene and a clinical phenotype consistent with TRPV4-associated disease (as determined by the investigator) OR"],"whoShouldSkip":["Medical history of other concomitant neurological disease or clinically significant physical exam/laboratory result that, in the opinion of the investigator, would render the patient being unsuitable for the study","Patients with a TRPV4 variant of unknown significance who are initially enrolled but then deemed to be unlikely to have a phenotype consistent with TRPV4-associated disease will no longer be eligible and their clinical data will be deleted"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 70 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.257Z"},{"nctId":"NCT05608434","title":"Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial","officialTitle":"Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nChildren with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.\n\nObjective:\n\nTo see if virtual reality-based games help improve thinking skills and brain function in children with ADHD.\n\nEligibility:\n\nChildren aged 8 to 16 years with ADHD.\n\nDesign:\n\nWe will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Participants may have an MRI scan of the brain. They may also have magnetoencephalography (MEG) and electroencephalography (EEG) scans, which record brain activity using sensors placed near or on the head. These scans are optional.\n\nParticipants will receive a set of virtual reality games. The set includes 3 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks.\n\nThe parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, and working memory.\n\nParticipants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played.\n\nThe brain scans may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.","conditions":["Attention Deficit Hyperactivity Disorder"],"keywords":["Virtual Reality","Smart Games","Neurodevelopmental","fMRI","Cognitive Training","EEG","MEG"],"interventions":[{"type":"BEHAVIORAL","name":"Non-adaptive Floreo VR control"},{"type":"BEHAVIORAL","name":"Floreo Virtual Reality application"}],"enrollment":219,"startDate":"2024-03-15","completionDate":"2028-09-01","sex":"ALL","minAge":"8 Years","maxAge":"16 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate, an individual must meet all of the following criteria:\n\n1. Children must provide informed assent and parents must provide informed consent to participate in the study.\n2. Any sex assigned at birth, or race/ethnicity.\n3. Aged between 8 and 16 years of age, including all months leading up to age 17. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age 17).\n4. Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation).\n5. A score of \\>12 on the ADHD-RS-5 inattention subscale at the screening/baseline assessment. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication) symptom levels.\n6. Stated willingness to comply with all study procedures and lifestyle considerations, availability for the duration of the study, and ability to travel to the NIH Clinical Center for the scheduled in-person study visits.\n7. For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.\n3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.\n4. Known to be pregnant.\n5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is considered to be one of the dominant sources of impairment for the child.\n6. Considered a suicide risk as determined during the clinical interview at baseline.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable).\n8. Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD.\n9. The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or children showing signs of undue neck and upper body strain or fatigue while trying the headset).\n10. For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). In addition, regular use of any other psychoactive (non-stimulant) medication that, in the opinion of the Investigator, may confound study data or interfere with completion of the intervention is exclusionary. Medications for ADHD will not be considered as exclusionary. This includes psychostimulants, atomoxetine, alpha 2 adrenergic agonists. Antidepressant and anxiolytic medication will also not be exclusionary if they are deemed not to interfere with study procedures\n11. For the main trial only: Prior use of Floreo's products including but not limited to their ADHD cognitive training application.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Saadia A Choudhury","phone":"(301) 437-0489","email":"saadia.choudhury@nih.gov"},{"name":"Daniel S Pine, M.D.","phone":"(301) 594-1318","email":"daniel.pine@nih.gov"}],"primaryOutcomes":["ADHD-RS-5 inattention sub-scale."],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: Non-adaptive Floreo VR control for Attention Deficit Hyperactivity Disorder","inPlainEnglish":"Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions.","whoItsFor":["Ages 8 Years to 16 Years","In order to be eligible to participate, an individual must meet all of the following criteria:","Any sex assigned at birth, or race/ethnicity","Aged between 8 and 16 years of age, including all months leading up to age 17. For the pilot only, the minimum age was 10 years (i.e., pilot participants were aged 10 to 16 years, including all months leading up to age 17)","A score of \\>12 on the ADHD-RS-5 inattention subscale at the screening/baseline assessment. For participants receiving ADHD medication at the time of assessment, the rating will reflect current (i.e., on-medication) symptom levels","Stated willingness to comply with all study procedures and lifestyle considerations, availability for the duration of the study, and ability to travel to the NIH Clinical Center for the scheduled in-person study visits"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders","Impairments in uncorrected visual acuity that would interfere with engagement with the VR training","Known to be pregnant","Considered a suicide risk as determined during the clinical interview at baseline","Any other medical or psychiatric condition that in the opinion of the PI may confound study data/assessments (e.g., limitations in mobility that would render the VR headset unusable)","Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD"],"whatHappens":"If you join, the listed intervention(s) are Non-adaptive Floreo VR control, or Floreo Virtual Reality application. The registry lists allocation as randomized. Background: Children with attention deficit hyperactivity disorder (ADHD) often have cognitive problems.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 219 people at Bethesda. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.654Z"},{"nctId":"NCT05614739","title":"FORAGER-1: A Study of Vepugratinib (LY3866288; LOXO-435) in Participants With Cancer With a Change in a Gene Called FGFR3","officialTitle":"FORAGER-1: A Phase 1, Open-Label, Multicenter Study of Vepugratinib (LY3866288; LOXO-435) in Locally Advanced or Metastatic Solid Tumors Including Urothelial Cancer and Muscle Invasive Bladder Cancer With FGFR3 Alterations","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene). Study participation could last up to approximately 6 years, depending on which part of the study you join.","conditions":["Urinary Bladder Neoplasms","Neoplasm Metastasis","Ureteral Neoplasms"],"keywords":["Bladder Cancer","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Renal Pelvis Cancer","Ureter Cancer","Non-Muscle Invasive Bladder Cancer","Muscle Invasive Bladder Cancer"],"interventions":[{"type":"DRUG","name":"Vepugratinib"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"enfortumab vedotin"},{"type":"DRUG","name":"Trastuzumab Deruxtecan"},{"type":"DRUG","name":"Midazolam"},{"type":"DRUG","name":"Digoxin"},{"type":"DRUG","name":"Rosuvastatin"}],"enrollment":677,"startDate":"2023-01-12","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration.\n* Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration.\n* Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib.\n* Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration.\n* Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2).\n* Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration.\n* Measurability of disease:\n\n  * Cohort A1, D1, and D2: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST v1.1).\n  * Cohorts A2, B1, B2, B4, B5, B7, and C1: Measurable disease required as defined by RECIST v1.1.\n  * Cohort B8: Baseline disease which includes at least 1 lesion.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of:\n\n  * 0 or 1 for Cohorts A1, A2, B5, B6, B7, and B8.\n  * Less than or equal to 2 for Cohorts B1, B2, B4, C1, DI and D2.\n* Cohort B6: Must be eligible for radical cystectomy plus pelvic lymph node dissection and agree to undergo curative intent standard radical cystectomy plus pelvic lymph node dissection.\n\nExclusion Criteria:\n\n* Participants with primary central nervous system (CNS) malignancy.\n* Untreated or uncontrolled CNS metastases.\n* Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible.\n* Any serious unresolved toxicities from prior therapy.\n* Significant cardiovascular disease.\n* Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF).\n* Active uncontrolled systemic infection or other clinically significant medical conditions.\n* Participants who are pregnant, lactating, or plan to breastfeed during the study or within 6 months of the last dose of study treatment. Participants who have stopped breastfeeding may be enrolled.\n* Cohort D1 only:\n\n  * Have had renal transplantation.\n  * Have a known history of nephrotic syndrome.\n  * Have uncontrolled fluid overload, including clinically significant ascites, pleural effusion, or peripheral edema.\n  * Have uncontrolled hypertension.\n  * Are on hemodialysis or similar.\n* Cohort D2 only:\n\n  * Have a history of:\n  * Ventricular tachycardia or ventricular fibrillation.\n  * Hypertrophic obstructive cardiomyopathy unless managed concurrently with atrial fibrillation.\n  * Wolff-Parkinson-White syndrome.\n  * Second- or third-degree atrioventricular block unless a functioning pacemaker is in place.\n  * Heart rate less than (\\<) 50 bpm.\n  * Have any of these medical conditions:\n  * Severe respiratory insufficiency.\n  * Sleep apnea syndrome.\n  * Myasthenia gravis.\n  * Acute narrow-angle glaucoma.\n  * Active liver disease or clinically significant hepatic impairment.\n  * History of myopathy or rhabdomyolysis with any HMG-CoA reductase inhibitor.","locations":[{"facility":"University of Arizona - Cancer Center","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles (UCLA) - Division of Hematology-Oncology","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California - Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California (UC) Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Medicine Cancer Center","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advent Health","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago Medical Center (UCMC)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University (IU) Melvin and Bren Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Bird Perkins Cancer Center","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Clinic Foundation","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Kimmel Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University (NYU)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester - Wilmot Cancer Institute","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina (UNC) - Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center (UCMC)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University (OSU)","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma - Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine Lancaster General Hospital - Ann B. Barshinger Cancer Institute","city":"Lancaster","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny General Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Urologic Research Center","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon and HCA Research 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Muenchen (TUM Klinikum)","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Tuebingen","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center, Beilinson Hospital","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Tel HaShomer","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"UOC Fase I - Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Chiba","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center Hospital","city":"Nagoya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Institute Hospital of JFCR","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus MC","city":"GE Rotterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haukeland University Hospital","city":"Bergen","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo University Hospital","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Catala d'Oncologia - L'Hospitalet","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion MD Anderson International Espana","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START) Madrid - CIOCC","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marques De Valdecilla","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Teaching Hospitals NHS Foundation Trust","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Overall Response Rate (ORR)","Pharmacokinetics (PK) of Vepugratinib: Area Under the Concentration versus Time Curve (AUC)","PK of Midazolam, Rosuvastatin, and Digoxin Administered Alone and in the Presence of Vepugratinib: Area Under the Concentration versus Time Curve (AUC[0-inf])","Complete Response Rate (CRR) in Participants with Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer (LG IR NMIBC)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":["pembrolizumab","trastuzumab-deruxtecan"],"locationSlugs":["tucson-arizona","duarte-california","los-angeles-california","orange-california","sacramento-california","stanford-california","orlando-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","baton-rouge-louisiana","new-orleans-louisiana","baltimore-maryland","boston-massachusetts","detroit-michigan","st-louis-missouri","new-york-new-york","rochester-new-york","the-bronx-new-york","chapel-hill-north-carolina","cincinnati-ohio","columbus-ohio","oklahoma-city-oklahoma","lancaster-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","myrtle-beach-south-carolina","nashville-tennessee","dallas-texas","houston-texas","salt-lake-city-utah","burlington-vermont","darlinghurst-australia","hunter-region-nsw-australia","st-leonards-australia","sydney-australia","toronto-canada","vancouver-canada","beijing-china","guangdong-china","hangzhou-china","shanghai-china","tianjin-china","xian-china","bordeaux-france","lyon-france","villejuif-france","bonn-germany","m-nchen-germany","t-bingen-germany","petah-tikva-israel","tel-hashomer-israel","milan-italy","roma-italy","chiba-japan","nagoya-japan","tokyo-japan","ge-rotterdam-netherlands","bergen-norway","oslo-norway","seoul-south-korea","barcelona-spain","madrid-spain","santander-spain","manchester-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Vepugratinib for Urinary Bladder Neoplasms","inPlainEnglish":"The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer. Vepugratinib may be used to treat cancer of the cells that line the urinary system and other solid tumor cancers that have a change in a particular gene (known as the FGFR3 gene).","whoItsFor":["Ages 18 Years to any","Cohort A1, C1, D1, and D2: Locally advanced or metastatic solid tumor malignancy with a qualifying FGFR3 alteration","Cohort A2, B2, B5 and B7: Urothelial cancer (UC) that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration","Cohorts B1 and B4: Urothelial cancer that is locally advanced or metastatic and have received prior erdafitinib","Cohort B6: Muscle Invasive Bladder Cancer with a qualifying FGFR3 alteration","Cohort B7: Urothelial cancer that is locally advanced or metastatic with a qualifying FGFR3 genetic alteration and expression of human epidermal growth factor receptor 2 (HER2)","Cohort B8: Low Grade Intermediate Risk Non-Muscle Invasive Bladder cancer and a qualifying FGFR3 genetic alteration","Measurability of disease:"],"whoShouldSkip":["Participants with primary central nervous system (CNS) malignancy","Untreated or uncontrolled CNS metastases","Current evidence of corneal keratopathy or retinal disorder. Individuals with asymptomatic ophthalmic conditions may be eligible","Any serious unresolved toxicities from prior therapy","Significant cardiovascular disease","Prolongation of the QT interval corrected for heart rate using Fridericia's formula (QTcF)","Active uncontrolled systemic infection or other clinically significant medical conditions"],"whatHappens":"If you join, the listed intervention(s) are Vepugratinib, Pembrolizumab, or enfortumab vedotin. The registry lists allocation as randomized. The main purpose of this study is to learn more about the safety, side effects, and effectiveness of Vepugratinib by itself or when it is combined with other medicines that treat cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 677 people at 83 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.308Z"},{"nctId":"NCT05621291","title":"A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...","officialTitle":"A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leukemia","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nChimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT.\n\nObjective:\n\nTo see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy.\n\nEligibility:\n\nPeople aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells.\n\nDesign:\n\nParticipants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours.\n\nParticipants will have blood drawn for testing on each visit.\n\nBone marrow biopsy/aspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip.\n\nA small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests.\n\nThe combined testing may help determine whether participants are eligible for HCT and/or at risk of relapse after CART.\n\nParticipants will be in the study for 2 years.","conditions":["B-All","Acute Lymphoblastic Leukemia"],"keywords":["B-All","Car-Cure","Result Monitoring"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"NGS testing"}],"enrollment":60,"startDate":"2026-11-15","completionDate":"2026-12-31","sex":"ALL","minAge":"1 Year","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Age \\>=1 year and \\<= 25 years old at the time of CD19 CART infusion\n* Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample\n\n  --Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.\n* Post-CD19 CART infusion disease status:\n\n  * Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.\n  * Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing.\n* Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs.\n\nStudy chairs will determine whether other 4-1BB CART are considered comparable.\n\n* All participants must have an allogeneic HCT donor identified for potential HCT. Note: Donor identification and selection will be according to institutional practice.\n* Have B-cell aplasia (BCA) post CD19 CART persisting within 42 days post CD19 CART infusion. Note: BCA persisting is defined as \\<1% B cells lymphocytes or \\<50 B cells/microliter in the peripheral blood\n* Performance of all screening tests prior to day 42 post CD19 CART.\n* The ability of participant or parent/guardian to understand and the willingness to sign a written consent document or participants unable to consent if they are represented by a Legally Authorized Representative (LAR).\n\nEXCLUSION CRITERIA:\n\n* Prior hematopoietic stem cell transplantation (HCT)\n* Recent history of the extramedullary disease (EMD) that requires ongoing radiographic surveillance (e.g., participants with active EMD at CD19 CART infusion that requires monitoring by imaging without the ability to more precisely assess disease status will be ineligible). A remote history of EMD does not exclude the participant.\n* Active and/or residual central nervous system (CNS) disease that requires ongoing therapy or monitoring.\n* Co-morbidities precluding myeloablative HCT. Note: Determination of co-morbidities precluding myeloablative HCT will be made by the treating transplant (HCT) physician and documented in the research record. This does not require that the participant is immediately fully eligible for HCT, only that there are no long-term comorbidities that would preclude a myeloablative approach (e.g., renal failure, severe cardiac failure, long-term oxygen requirement).\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements. Note: Determination of uncontrolled, symptomatic illness or social situation that would limit compliance with the study requirements will be made by the site-PI and documented in the research record.","locations":[{"facility":"Children's Hospital of Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber/Boston Children s Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute, University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's, University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Research Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Ped LeukemiaLymph Cell Tx Tm","phone":"(240) 760-6970","email":"ncilltct@mail.nih.gov"},{"name":"Alexandra Dreyzin, M.D.","phone":"(301) 451-4801","email":"alexandra.dreyzin@nih.gov"}],"primaryOutcomes":["Efficacy of novel biomarker-guided risk based strategy to monitor remission"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":["car-t"],"locationSlugs":["los-angeles-california","washington-d-c-district-of-columbia","atlanta-georgia","bethesda-maryland","boston-massachusetts","salt-lake-city-utah","seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: NGS testing for B-All","inPlainEnglish":"Background: Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy.","whoItsFor":["Ages 1 Year to 25 Years","Age \\>=1 year and \\<= 25 years old at the time of CD19 CART infusion","Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample","Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing","Post-CD19 CART infusion disease status:","Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion","Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing","Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs"],"whoShouldSkip":["Prior hematopoietic stem cell transplantation (HCT)","Active and/or residual central nervous system (CNS) disease that requires ongoing therapy or monitoring"],"whatHappens":"If you join, the listed intervention(s) are NGS testing. The registry lists allocation as na. Background: Chimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.814Z"},{"nctId":"NCT05631249","title":"Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C","officialTitle":"An Interventional and Translational Study Investigating Sotorasib in Previously Treated Locally Advanced or Metastatic NSCLC Subjects With Mutated KRAS p.G12C","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","sponsorClass":"OTHER","summary":"This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.","conditions":["KRAS P.G12C","Non Small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sotorasib 120Mg Tab"}],"enrollment":40,"startDate":"2022-12-13","completionDate":"2027-12-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age higher than 18 years;\n* ECOG less or equal to 1 at the time of screening;\n* Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);\n* Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease.\n* Life expectancy of longer than 3 months from the time of screening, in the opinion of the investigator;\n* Patients must have lesions easily accessible to biopsy and must have accepted to perform pre-treatment, on-treatment and end-of-treatment biopsies;\n* Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration\n* Patients must understand, sign and date the written informed consent from prior to any protocol-specific procedures performed.\n* Patients should be able and willing to comply with study visits and procedures as per protocol.\n* Patients must be affiliated to a Social Security System or beneficiary of the same.\n\nExclusion Criteria:\n\n* Patient unwilling to participate to the biological investigations and to perform biopsies and blood sample collection as required in the protocol;\n* Use of known cytochrome P450 (CYP) 3A4 or P-gp sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to registration, that was not reviewed and approved by the principal investigator.\n* Use of strong inducers of CYP3A4 (including herbal supplements such as St. John's wort) within 14 days or 5 half-lives (whichever is longer) prior to registration, that was not reviewed and approved by the principal investigator.\n* Inadequate washout period prior to registration, defined as: Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study shorter than 14 days or 5 half-lives;\n* Prior treatment with a KRAS inhibitor.\n* Major surgery within 28 days of registration.\n* Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication.\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias or unstable angina.\n* Severe infections within 2 weeks prior to registration, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia. Prophylactic antibiotics are allowed.\n* Baseline or unresolved pneumonitis from prior treatment;\n* Current CTCAE version 5.0 grade higher or equal to 2 peripheral neuropathy.\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Subjects with PleurX catheters in place may be considered for the study with Principal Investigator approval.\n* Known history of Human Immunodeficiency Virus (HIV) infection\n* Exclusion of hepatitis infection based on the following results and/or criteria:\n\n  1. Positive hepatitis B surface antigen (HepBsAg) (indicative of chronic Hepatitis B or recent acute hepatitis B)\n  2. Negative HepBsAg with a positive for hepatitis B core antibody (Hepatitis B core antibody testing is not required for screening, however if this is done and is positive, then hepatitis B surface antibody \\[Anti-HBs\\] testing is necessary.\n\n     Undetectable anti-HBs in this setting would suggest unclear and possible infection, and needs exclusion).\n  3. Positive Hepatitis C virus antibody: Hepatitis C virus RNA by polymerase chain reaction is necessary. Detectable Hepatitis C virus RNA renders the subject ineligible.\n* Leptomeningeal disease and active brain metastases. Subjects who have had brain metastases resected or have received whole brain radiation therapy or stereotactic radiosurgery ending at least 2 weeks prior to registration are eligible if they meet all of the following criteria:\n\n  1. residual neurological symptoms grade less or equal to 2;\n  2. on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and\n  3. follow-up brain imaging performed within 30 days of enrollment shows no progression or new lesions appearing.\n* Female subject is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 7 days after the last dose of sotorasib or during treatment if planning to become pregnant.\n* Female subjects of childbearing potential unwilling to use 1 highly effective method of contraception during treatment and for an additional 7 days after the last dose of sotorasib\n* Female subjects of childbearing potential with a positive pregnancy test assessed at Screening or day 1 by a serum pregnancy test and/or urine pregnancy test.\n* Male subjects with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib\n* Male subjects with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib\n* Male subjects unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of investigational product.\n* Any evidence of primary malignancy other than locally advanced or metastatic lung cancer at within 3 years of registration, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated;\n* Participation in another clinical trial evaluating an experimental drug (except non-interventional research).\n* Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.\n* Hypersensitivity to the active substance or to any excipient\n* Patients with hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption","locations":[{"facility":"Centre Léon Bérard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HM Hôpital Nord","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Paris Saint Joseph","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HP Hôpital Tenon","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lynda MATI","phone":"+33 1 42 11 42 11","email":"Lynda.mati@gustaveroussy.fr"}],"primaryOutcomes":["Tumor response assessment"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["lyon-france","marseille-france","paris-france","villejuif-france"],"enrichment":{"headline":"Phase 2: testing Sotorasib 120Mg Tab for KRAS P.G12C","inPlainEnglish":"This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.","whoItsFor":["Ages 18 Years to any","Age higher than 18 years;","ECOG less or equal to 1 at the time of screening;","Pathologically documented, previously treated, locally-advanced and unresectable or metastatic NSCLC with KRAS p.G12C mutation confirmed through molecular testing (results of both tissue and liquid biopsy are accepted);","Subjects will have progressed or experienced disease recurrence on or after receiving at least 1 prior systemic therapy for locally advanced and unresectable or metastatic disease","Life expectancy of longer than 3 months from the time of screening, in the opinion of the investigator;","Patients must have lesions easily accessible to biopsy and must have accepted to perform pre-treatment, on-treatment and end-of-treatment biopsies;","Have adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to registration"],"whoShouldSkip":["Use of strong inducers of CYP3A4 (including herbal supplements such as St. John's wort) within 14 days or 5 half-lives (whichever is longer) prior to registration, that was not reviewed and approved by the principal investigator","Inadequate washout period prior to registration, defined as: Any cytotoxic chemotherapy, investigational agents or other anticancer drug(s) from a previous cancer treatment regimen or clinical study shorter than 14 days or 5 half-lives;","Prior treatment with a KRAS inhibitor","Major surgery within 28 days of registration","Significant gastrointestinal disorder that results in significant malabsorption, requirement for intravenous alimentation, or inability to take oral medication","Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to registration, unstable arrhythmias or unstable angina","Severe infections within 2 weeks prior to registration, but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia. Prophylactic antibiotics are allowed"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib 120Mg Tab. The registry lists allocation as na. This study aims to provide a comprehensive understanding of sotorasib's mechanisms of action and resistance in NSCLC patients.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.974Z"},{"nctId":"NCT05632757","title":"Anticipated Patient and Caregiver Burden","officialTitle":"Anticipated Patient and Caregiver Burden: Impact in People With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Assistance Publique Hopitaux De Marseille","sponsorClass":"OTHER","summary":"Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years. The severity of the disease, the progressive loss of autonomy that leads to dependence on family and caregivers, and the lack of effective treatment sometimes leads patients to a loss of hope and to dark thoughts. The prevalence of suicidal ideation is high, with more than one third of people with ALS experiencing it. The psychological suffering of patients is often associated with that of their caregivers. The evaluation of the patients' feeling of being a burden has rarely been addressed in previous studies in ALS on the notion of burden. In this work, the investigators wish to evaluate the patient's ideas of death by also taking into account the caregiver's burden and the patient's feeling of being a burden. They wish to better understand this difficult experience by refocusing the study on the patient himself, which has rarely been addressed in studies on ALS and the notion of burden. By working on the caregiver's burden, both from the caregiver's point of view and as perceived by the patient, the investigators hope to find avenues of intervention and define actions that could help patients and their families and improve the quality of life of the patient-caregiver couple.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["amyotrophic lateral sclerosis","caregiver","burden","depression"],"interventions":[{"type":"BEHAVIORAL","name":"Psychological assessments"}],"enrollment":126,"startDate":"2023-06-22","completionDate":"2026-12-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria (patient) :\n\n* Patient is at least 18 years of age.\n* Patient having given informed consent\n* Patient with ALS who has already had at least two multidisciplinary assessments in the ALS center in Marseille with an evaluation by the clinical psychologist.\n* Patient with a motor handicap of grade 3 to 5 on the Rankin score\n* Patient with a primary family caregiver at home (spouse, child) willing to participate in the study\n* Patient who is a beneficiary of or affiliated with a social security plan\n\nInclusion Criteria (caregiver) :\n\n* Adult subject at least 18 years of age.\n* Subject who has given informed consent.\n* Primary family caregiver of a patient with ALS who agrees to participate in the study\n* Caregiver present during hospital visits.\n\nExclusion Criteria (patient):\n\n* Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)\n* Autonomous patient, who does not need the help of a third party for the basic gestures of daily life (Rankin 0 to 2)\n* Patient living in an institution or alone at home\n* Patient with cognitive impairment that interferes with activities of daily living\n* Patients with marked emotional lability (spasmodic crying) due to ALS\n* Patients who have had a recent diagnosis of their disease (less than 6 months)\n* Patients who are unaware of the severity of their condition\n* Any condition that in the opinion of the investigator or psychologist would not be compatible with the study.\n\nExclusion Criteria (caregiver):\n\n* Subjects with severe and unstable cardiac, oncological, hepatic, renal or other illnesses.\n* Subject with a history of psychiatric illness","locations":[{"facility":"Service Maladies neuromusculaires et SLA","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Annie Verschueren","phone":"0491386578","email":"annie.verschueren@ap-hm.fr"},{"name":"Annie Verschueren","phone":"","email":""}],"primaryOutcomes":["Impact of the patient's sense of being a burden on the patient's suicidal ideation"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["marseille-france"],"enrichment":{"headline":"Not a traditional drug phase: Psychological assessments for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years. The severity of the disease, the progressive loss of autonomy that leads to dependence on family and caregivers, and the lack of effective treatment sometimes leads patients to a loss of hope and to dark thoughts.","whoItsFor":["Ages 18 Years to any","Patient is at least 18 years of age","Patient with ALS who has already had at least two multidisciplinary assessments in the ALS center in Marseille with an evaluation by the clinical psychologist","Patient with a motor handicap of grade 3 to 5 on the Rankin score","Patient who is a beneficiary of or affiliated with a social security plan","who can join (caregiver) :","Adult subject at least 18 years of age","Primary family caregiver of a patient with ALS who agrees to participate in the study"],"whoShouldSkip":["Patients with a serious and unstable associated disease, cardiac, oncological, hepatic or renal, psychiatric (schizophrenia, bipolar)","Autonomous patient, who does not need the help of a third party for the basic gestures of daily life (Rankin 0 to 2)","Patient living in an institution or alone at home","Patient with cognitive impairment that interferes with activities of daily living","Patients with marked emotional lability (spasmodic crying) due to ALS","Patients who have had a recent diagnosis of their disease (less than 6 months)","Patients who are unaware of the severity of their condition"],"whatHappens":"If you join, the listed intervention(s) are Psychological assessments. The registry lists allocation as na. Amyotrophic lateral sclerosis (ALS) is a degenerative neurological disease that causes progressive motor disability and is life threatening within a few years.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 126 people at Marseille. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.603Z"},{"nctId":"NCT05634967","title":"Kesimpta (Ofatumumab) Pregnancy Registry","officialTitle":"Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.","conditions":["Multiple Sclerosis","Pregnancy"],"keywords":["PASS","Kesimpta","ofatumumab","Pregnancy","Multiple Sclerosis"],"interventions":[{"type":"OTHER","name":"Kesimpta"}],"enrollment":725,"startDate":"2023-01-05","completionDate":"2033-02-28","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:\n\nCohort 1: Kesimpta-Exposed Cohort\n\n1. Pregnant women\n2. Diagnosed with MS, with the indication validated by medical records when possible\n3. Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy\n4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children\n\nCohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)\n\n1. Pregnant women\n2. Diagnosed with MS, with the indication validated by medical records when possible\n3. May or may not have taken another medication for MS in the current pregnancy\n4. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children\n\nCohort 3: Healthy Comparison Cohort (Comparison Group 2):Kesimpta-OTIS sub-study specific\n\n1. Pregnant women\n2. Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants, and validated developmental performance questionnaire in live born children\n\nExclusion Criteria:\n\nWomen meeting any of the following criteria will be excluded from the cohort study:\n\nCohort 1: Kesimpta-Exposed Cohort\n\n1. Women who have enrolled in the Kesimpta cohort study with a previous pregnancy\n2. Women who have used Kesimpta for an indication other than a currently approved indication\n3. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:\n\n   * Other anti-CD20 monoclonal antibody: same class as Kesimpta\n   * S1P modulators: same class as Mayzent\n   * Cladribine (Mavenclad): Based on the US label, animal studies indicate that there is positive evidence of teratogenicity for Cladribine\n   * Teriflunomide (Aubagio): The teratogenecity of teriflunomide is unknown and currently under investigation.\n   * New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.\n4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)\n5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.\n\nCohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)\n\n1. Administered Kesimpta 166 days before the first day of LMP or anytime during pregnancy\n2. Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) of conception:\n\n   * Anti CD-20 monoclonal antibody\n   * Cladribine (Mavenclad)\n   * S1P modulators\n   * Teriflunomide (Aubagio) New medications (marketed after 2021) indicated for the treatment of MS will be evaluated for inclusion/exclusion criteria as the study progresses.\n3. Women who have enrolled in the Kesimpta cohort or BAF312A2403 Mayzent cohort with a previous pregnancy\n4. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)\n5. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.\n\nCohort 3: Healthy Comparison Cohort (Comparison Group 2): Only applicable to Kesimpta-OTIS sub-study\n\n1. Administered Kesimpta 166 days before or Mayzent 4 days after the first day of LMP or anytime during pregnancy\n2. Women who have a diagnosis of a MS\n3. Women who have a current diagnosis of any autoimmune disease\n4. Women who have first contact with the project after prenatal diagnosis of any major structural defect\n5. Women treated with Mayzent or Kesimpta for non-MS indication\n6. Retrospective enrollment after the outcome of pregnancy is known (i.e. the pregnancy has ended prior to enrollment)\n7. Results of diagnostic test(s) that are positive for a major structural defect prior to enrollment. However, women who have had any normal or abnormal prenatal screening or diagnostic test prior to enrollment are eligible as long as the test result does not indicate a major structural defect.\n8. Women exposed to a known human teratogenic drugs during pregnancy","locations":[{"facility":"University of California San Diego OTIS","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"mothertobaby@health.ucsd.edu"}],"primaryOutcomes":["Number of participants with major structural defects"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Not a traditional drug phase: Kesimpta for Multiple Sclerosis","inPlainEnglish":"The Kesimpta Pregnancy Registry is an watch-and-measure (no experimental treatment required), exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.","whoItsFor":["Ages 18 Years to 100 Years","Participants must meet all the criteria listed under the respective cohorts to enroll in that particular cohort of the registry:","Cohort 1: Kesimpta-Exposed Cohort","Diagnosed with MS, with the indication validated by medical records when possible","Administered Kesimpta for the treatment of MS at any time from 166 days prior to the first day of the LMP, or up to and including the end of pregnancy","Agree to the conditions and requirements of the study including the interview schedule, release of medical records, the dysmorphology examination of live born infants (OTIS specific), and validated developmental performance questionnaire in live born children","Cohort 2: Disease-Matched Comparison Cohort (Comparison Group 1)","May or may not have taken another medication for MS in the current pregnancy"],"whoShouldSkip":["Women meeting any of the following criteria will be excluded from the cohort study:","Cohort 1: Kesimpta-Exposed Cohort","Women who have enrolled in the Kesimpta cohort study with a previous pregnancy","Women who have used Kesimpta for an indication other than a currently approved indication","Women with exposure to any of the following medications within 5 half-lives (or pharmacodynamic effect when relevant) prior to conception:","Other anti-CD20 monoclonal antibody: same class as Kesimpta","S1P modulators: same class as Mayzent"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 725 people at La Jolla. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.968Z"},{"nctId":"NCT05646316","title":"Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer","officialTitle":"A Phase III Trial Of The Impact Of Sentinel Lymph Node Mapping On Patient Reported Lower Extremity Limb Dysfunction In Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NRG Oncology","sponsorClass":"OTHER","summary":"This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes. Sentinel lymph node mapping uses a special dye and camera to look for cancer that may have spread to nearby lymph nodes. Comparing the results of the procedures may help doctors predict the risk of long-term swelling in the legs.","conditions":["Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Diagnostic Imaging Testing"},{"type":"PROCEDURE","name":"Excisional Biopsy"},{"type":"DRUG","name":"Indocyanine Green Solution"},{"type":"PROCEDURE","name":"Minimally Invasive Surgery"},{"type":"PROCEDURE","name":"Pelvic Lymphadenectomy"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"PROCEDURE","name":"Sentinel Lymph Node Mapping"}],"enrollment":428,"startDate":"2022-12-07","completionDate":"2029-03-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration\n* Clinical stage I endometrial cancer based on the following diagnostic workup:\n\n  * History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information\n* Patients must speak English, Spanish, or Korean\n\nExclusion Criteria:\n\n* Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)\n* History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable\n* History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes\n* Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)\n* Patients with severe, active co-morbidity defined as follows:\n\n  * History of patient or provider identified lower extremity lymphedema\n  * History of patient or provider identified chronic lower extremity swelling\n  * History of lower extremity or pelvic deep venous thromboembolism within 90 days of registration\n  * History of lower extremity cellulitis within 90 days of registration","locations":[{"facility":"George Washington University Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Coral Gables","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Deerfield Beach","city":"Deerfield Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Doral","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Miller School of Medicine-Sylvester Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Kendall","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Sylvester Comprehensive Cancer Center at Sole Mia","city":"North Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Plantation","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University Medical Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Warrenville","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IU Health North Hospital","city":"Carmel","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University/Melvin and Bren Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Jefferson Medical Center","city":"Marrero","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Jefferson General Hospital","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU Healthcare Network / Metairie Multi-Specialty Clinic","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louisiana State University Health Science Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center New Orleans","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland/Greenebaum Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Upper Chesapeake Medical Center","city":"Bel Air","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wayne State University/Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weisberg Cancer Treatment Center","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McLaren Cancer Institute-Flint","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairview Southdale Hospital","city":"Edina","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairview Clinics and Surgery Center Maple Grove","city":"Maple Grove","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint John's Hospital - Healtheast","city":"Maplewood","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairview Northland Medical Center","city":"Princeton","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regions Hospital","city":"Saint Paul","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairview Lakes Medical Center","city":"Wyoming","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Springfield","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Healthcare","city":"Billings","state":"Montana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Frontier Cancer Center","city":"Billings","state":"Montana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health West End Clinic","city":"Billings","state":"Montana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Saint James Community Hospital and Cancer Treatment Center","city":"Butte","state":"Montana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fred and Pamela Buffett Cancer Center - Kearney","city":"Kearney","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Medicine-Village Pointe","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alegent Health Bergan Mercy Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Cancer Center of Nevada","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bryn Mawr Hospital","city":"Bryn Mawr","state":"Pennsylvania","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Paoli Memorial Hospital","city":"Paoli","state":"Pennsylvania","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Lankenau Medical Center","city":"Wynnewood","state":"Pennsylvania","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Women and Infants Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkland Memorial Hospital","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern/Simmons Cancer Center-Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern/Simmons Cancer Center-Fort Worth","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hermann Texas Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Methodist Willowbrook Hospital","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist West Hospital","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Clinical Center at Richardson/Plano","city":"Richardson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Sugar Land Hospital","city":"Sugar Land","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist The Woodlands Hospital","city":"The Woodlands","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Changwon Hospital","city":"Seoul","state":"Gyeongsangnam-do","country":"South Korea","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Gachon University Gil Hospital","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gangnam Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ewha Woman's University Mokdong Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of patient-reported lower extremity limb dysfunction"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","coral-gables-florida","deerfield-beach-florida","doral-florida","miami-florida","north-miami-florida","plantation-florida","augusta-georgia","chicago-illinois","warrenville-illinois","carmel-indiana","indianapolis-indiana","marrero-louisiana","metairie-louisiana","new-orleans-louisiana","baltimore-maryland","bel-air-maryland","detroit-michigan","farmington-hills-michigan","flint-michigan","edina-minnesota","maple-grove-minnesota","maplewood-minnesota","princeton-minnesota","saint-paul-minnesota","wyoming-minnesota","springfield-missouri","billings-montana","butte-montana","kearney-nebraska","omaha-nebraska","las-vegas-nevada","oklahoma-city-oklahoma","bryn-mawr-pennsylvania","paoli-pennsylvania","wynnewood-pennsylvania","providence-rhode-island","dallas-texas","fort-worth-texas","houston-texas","richardson-texas","sugar-land-texas","the-woodlands-texas","charlottesville-virginia","seoul-south-korea","incheon-south-korea"],"enrichment":{"headline":"Phase 3: testing Indocyanine Green Solution for Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8","inPlainEnglish":"This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer. Standard lymph node dissection removes lymph nodes around the uterus during a hysterectomy to look for spread of cancer from the uterus to nearby lymph nodes.","whoItsFor":["Ages 18 Years to any","Women only","Histologically proven diagnosis of endometrial cancer based on endometrial sampling with a plan to undergo laparoscopic or robotic hysterectomy and lymphatic assessment as part of primary management. Biopsy must be performed within 90 days prior to registration","Clinical stage I endometrial cancer based on the following diagnostic workup:","History/physical examination within 30 days prior to registration is reassuring for the absence of metastatic disease","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2","Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial"],"whoShouldSkip":["Patients whom the surgeon believes is not a candidate for pelvic lymphadenectomy due to medical comorbidities or other technical challenges (i.e. morbid obesity or prior surgery)","History of chemotherapy or immunotherapy for the treatment of endometrial cancer. Progestin-containing therapies such as megestrol, medroxyprogesterone, or levonorgestrel-containing intrauterine device (IUD) are acceptable","History of radiation to the pelvis, groin or lower extremities, or surgery to the pelvic lymph nodes or inguinal lymph nodes","Patients who are going to undergo another elective surgery during the same operative event as their hysterectomy (i.e., sacrocolpopexy, cholecystectomy)","Patients with severe, active co-morbidity defined as follows:","History of patient or provider identified lower extremity lymphedema","History of patient or provider identified chronic lower extremity swelling"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Diagnostic Imaging Testing, or Excisional Biopsy. The registry lists allocation as randomized. This phase III trial compares the effect of sentinel lymph node mapping to standard lymph node dissection in reducing the risk of swelling in the legs (lymphedema) in patients undergoing a hysterectomy for stage I endometrial cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 428 people at 60 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.693Z"},{"nctId":"NCT05650632","title":"A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma","officialTitle":"A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed/refractory (R/R) MM.\n\nEtentamig (ABBV-383) is an investigational drug being developed for the treatment of R/R Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \\& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \\& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). In Arm E, etentamig (ABBV-383) will be investigated for outpatient administration. Around 250 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 50 sites across the world.\n\nParticipants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.","conditions":["Multiple Myeloma"],"keywords":["Multiple Myeloma","Cancer","ABBV-383","B-Cell Maturation Antigen"],"interventions":[{"type":"DRUG","name":"Etentamig (ABBV-383)"}],"enrollment":250,"startDate":"2023-03-21","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have measurable disease as outlined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance of \\<= 2. Arm C and Arm D: ECOG performance of \\<= 1.\n* Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.\n* Must be naïve to treatment with etentamig (ABBV-383).\n* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.\n* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \\[ADC\\] or chimeric antigen receptor T-cell \\[CAR-T\\] directed against BCMA).\n* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n* Arm E: Must have received 1 line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must have never received BCMA-targeted therapy.\n\nExclusion Criteria:\n\n* Arm A: Received BCMA-targeted therapy.\n* Arm C and Arm D: Rapidly progressing disease per investigator.","locations":[{"facility":"Mayo Clinic Arizona /ID# 251405","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Springdale /ID# 267742","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers - Aurora /ID# 268574","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Hematology Consultants /ID# 268560","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope And Healing Cancer Services /ID# 268536","city":"Hinsdale","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Wayne Medical Oncology And Hematology /ID# 268179","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscan St. Francis Health /ID# 280928","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Jefferson General Hospital /ID# 251204","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester /ID# 251164","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Revive Research Institute, LLC /ID# 267869","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists - Omaha - Wright Street /ID# 282497","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai /ID# 251166","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center-Koch Center /ID# 251167","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina /ID# 251203","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Wake Forest Baptist Medical Center /ID# 251165","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of Cincinnati Medical Center /ID# 251746","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Willamette Valley Cancer Institute and Research Center /ID# 267088","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt Ingram Cancer Center /ID# 252470","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Central/South Texas /ID# 268563","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Dallas - Worth Street /ID# 280064","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants /ID# 268323","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas /ID# 268877","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists - Fairfax /ID# 268559","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center - Seattle - Eastlake Avenue East /ID# 267940","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties Tacoma /ID# 267117","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juravinski Cancer Centre /ID# 252053","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ottawa Hospital Research Institute /ID# 252151","city":"Ottawa","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Odense University Hospital /ID# 251261","city":"Odense","state":"Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vejle Sygehus /ID# 251260","city":"Vejle","state":"Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli-Calmettes /ID# 252100","city":"Marseille","state":"Bouches-du-Rhone","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 252101","city":"Créteil","state":"Paris","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 251196","city":"Nantes","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCL - Hopital Lyon Sud /ID# 251223","city":"Pierre-Bénite","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Poitiers - La miletrie /ID# 251219","city":"Poitiers","state":"Vienne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HP - Hopital Saint-Antoine /ID# 252326","city":"Paris","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rabin Medical Center. /ID# 251330","city":"Petah Tikva","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center-Hebrew University /ID# 252079","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center /ID# 251329","city":"Ramat Gan","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center /ID# 251573","city":"Tel Aviv","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marques de Valdecilla /ID# 251528","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Puerta de Hierro - Majadahonda /ID# 251545","city":"Majadahonda","state":"Madrid","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Universitario de Salamanca /ID# 251529","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLH NHS FT - NIHR UCLH Clinical Research Facility /ID# 251357","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital /ID# 251774","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Arm A (Part 1 and Part 2) Arm C, Arm D, and Arm E: Number of Grade >= 2 Cytokine Release Syndrome (CRS) Events","Arm B: Number of Adverse Events (AEs) of Special Interest (CRS and Immune Effector Cell-associated Neurotoxicity Syndrome [ICANS])"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","springdale-arkansas","aurora-colorado","newark-delaware","hinsdale-illinois","fort-wayne-indiana","indianapolis-indiana","metairie-louisiana","rochester-minnesota","lincoln-nebraska","omaha-nebraska","new-york-new-york","chapel-hill-north-carolina","winston-salem-north-carolina","cincinnati-ohio","eugene-oregon","nashville-tennessee","austin-texas","dallas-texas","houston-texas","tyler-texas","fairfax-virginia","seattle-washington","tacoma-washington","hamilton-canada","ottawa-canada","odense-denmark","vejle-denmark","marseille-france","cr-teil-france","nantes-france","pierre-b-nite-france","poitiers-france","paris-france","petah-tikva-israel","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","santander-spain","majadahonda-spain","salamanca-spain","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Etentamig (ABBV-383) for Multiple Myeloma","inPlainEnglish":"Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure.","whoItsFor":["Ages 18 Years to any","Must have measurable disease as outlined in the protocol","Eastern Cooperative Oncology Group (ECOG) performance of \\<= 2. Arm C and Arm D: ECOG performance of \\<= 1","Relapsed/refractory (R/R) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria","Must be naïve to treatment with etentamig (ABBV-383)","Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody","Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383)","Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383)"],"whoShouldSkip":["Arm A: Received BCMA-targeted therapy","Arm C and Arm D: Rapidly progressing disease per investigator"],"whatHappens":"If you join, the listed intervention(s) are Etentamig (ABBV-383). The registry lists allocation as randomized. Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 250 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.482Z"},{"nctId":"NCT05652335","title":"A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated Amyloid Light-chain (AL) Amyloidosis","officialTitle":"Phase 1, First-in-Human, Dose Escalation Study of JNJ-79635322, a Trispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma or Previously Treated AL Amyloidosis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\\[s\\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the safety and tolerability of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).","conditions":["Relapsed or Refractory Multiple Myeloma","Previously Treated Amyloid Light-chain (AL) Amyloidosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"JNJ-79635322"}],"enrollment":180,"startDate":"2022-11-22","completionDate":"2027-04-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria\n* Part 1: Have relapsed or refractory disease, have been treated with a proteasome inhibitor, immunomodulatory drug (IMiD) agent, and an anti-CD38-based therapy for the treatment of multiple myeloma (MM),and should have been treated with at least 3 prior lines of therapy, or are refractory to proteosome inhibitor, IMiD agent, and an anti-CD38-based therapy regardless of prior lines of therapy, Part 2: Have relapsed or refractory disease, have been treated with a PI, IMiD and an anti-CD38 based therapy\n* Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Have measurable disease at screening as defined by at least 1 of the following: a) Serum M-protein level greater than or equal to (\\>=) 0.5 grams per deciliter (g/dL); or b) Urine M-protein level \\>=200 milligrams (mg)/24 hours; or c) Light chain multiple myeloma: Serum immunoglobulin (Ig) free light chain (FLC) \\>=10 milligrams per deciliter (mg/dL) and abnormal serum Ig kappa lambda FLC ratio; d) For participants without measurable disease in the serum, urine, or involved FLC, presence of 1 or more focus of extramedullary disease (EMD) which meets the following criteria: extramedullary plasmacytoma not contiguous with a bone lesion, at least 1 lesion \\>=2 centimeter \\[cm\\] (at its greatest dimension) diameter on whole body Positron Emission Tomography and Computed Tomography (PET-CT) Scans (or whole body magnetic resonance imaging \\[MRI\\] approved by sponsor), and not previously radiated (Part 2C participants are not required to have measurable disease)\n\nFor participants with previously treated AL amyloidosis:\n\n* Initial histopathological diagnosis of amyloidosis\n* Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis\n* Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \\>=50 mg/L or difference between involved and uninvolved free light chains (dFLC) \\>=50 mg/L, or serum m-protein \\>= 0.5 g/dL\n* One or more organs impacted by systemic AL amyloidosis\n* Left ventricular ejection fraction (LVEF) \\>=45%\n\nExclusion Criteria:\n\nFor participants with relapsed or refractory multiple myeloma:\n\n* Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis\n* Received a cumulative dose of corticosteroids equivalent to greater than (\\>) 140 mg of prednisone within the 14-day period before the start of study treatment administration\n* Prior antitumor therapy as follows, in the specified time frame prior to the first dose of study treatment: (proteasome inhibitor \\[PI\\] therapy or radiotherapy within 14 days, immunomodulatory drug (IMiD) agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days \\[not applicable for Part 2C participants\\], or CD3-redirecting therapy within 21 days\\[not applicable for Part 2B or 2C participants\\])\n* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\\<=) 1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\<=3)\n* The following medical conditions: pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency (HIV) infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, autoimmune disease, serious active viral or bacterial infection, uncontrolled systemic fungal infection, cardiac conditions (myocardial infarction \\<=6 months prior to enrollment, New York Heart Association stage III or IV congestive heart failure, et cetera)\n* Part 2C: have progressive disease or refractory disease per IMWG after CAR-T administration\n\nFor participants with previously treated AL amyloidosis:\n\n* CNS involvement or clinical signs of meningeal involvement of AL amyloidosis. If either is suspected, whole brain MRI and lumbar cytology are required\n* Any form of non-AL amyloidosis, including but not limited to transthyretin (ATTR) amyloidosis\n* Active plasma cell leukemia, Waldenstrom's macroglobulinemia, or POEMS syndrome\n* Pulmonary compromise requiring supplemental oxygen use\n* Any serious medical conditions such as: active viral, bacterial, fungal infection; active autoimmune disease; HIV infection, active hepatitis B or C infection, stroke or seizure within 6 months prior to first dose of study treatment, significant cardiovascular conditions\n* Previous or current diagnosis of symptomatic multiple myeloma\n* Macroglossia that impairs swallowing difficulty\n* Received a cumulative dose of corticosteroids equivalent to \\> 140 mg of prednisone within the 14-day period before the start of study treatment administration\n* Prior antitumor therapy within 21 days prior to the first dose of study treatment (PI therapy or radiotherapy within 14 days, IMiD agent therapy within 7 days, gene-modified adoptive cell therapy within 90 days, or CD3-redirecting therapy within 21 days)\n* Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration\n* Live, attenuated vaccine within 4 weeks before the first dose of study treatment\n* Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to \\<=1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\<=3)","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Orange County Lennar Foundation Cancer Center","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Blood Cancer Institute","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mt. Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania Division of Hematology Oncology Perelman Center for Advanced Medicine","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Antwerpen","city":"Edegem","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Liege","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Nantes","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Lyon Sud","city":"Pierre-Bénite","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu Rennes Hopital Pontchaillou","city":"Rennes","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Institut Claudius Regaud","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Medical Center","city":"Shibuya City","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Osaka University Hospital","city":"Suita-shi","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Tokyo","state":"","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"VUMC Amsterdam","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Groningen","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMC Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. Germans Trias I Pujol","city":"Badalona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Univ Fund Jimenez Diaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Univ. de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Clinico Univ de Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"Sutton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Part 1: Number of Participants with Dose-limiting Toxicity (DLT)","Parts 1 and 2: Number of Participants with Adverse Events (AEs) by Severity","Part 2: Number of Participants with Abnormalities in Laboratory Values"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["duarte-california","irvine-california","san-francisco-california","denver-colorado","new-york-new-york","charlotte-north-carolina","philadelphia-pennsylvania","houston-texas","edegem-belgium","ghent-belgium","li-ge-belgium","nantes-france","pierre-b-nite-france","rennes-france","toulouse-france","shibuya-city-japan","suita-shi-japan","tokyo-japan","amsterdam-netherlands","groningen-netherlands","utrecht-netherlands","badalona-spain","barcelona-spain","madrid-spain","pamplona-spain","salamanca-spain","london-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing JNJ-79635322 for Relapsed or Refractory Multiple Myeloma","inPlainEnglish":"The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\\[s\\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the whether it is safe and how hard side effects are to live with of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).","whoItsFor":["Ages 18 Years to any","For participants with relapsed or refractory multiple myeloma:","Have a documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria","Must have an Eastern Cooperative Oncology Group (ECOG) status of 0 or 1","For participants with previously treated AL amyloidosis:","Initial histopathological diagnosis of amyloidosis","Participant who is not a candidate for available AL amyloidosis therapy with established clinical benefit and should have received at least 3 cycles of 1 prior line of therapy or a total of at least 2 cycles of 2 or more prior lines of therapy for AL amyloidosis","Measurable disease at screening defined by at least 1 of the following: serum involved free light chain (iFLC) \\>=50 mg/L or difference between involved and uninvolved free light chains (dFLC) \\>=50 mg/L, or serum m-protein \\>= 0.5 g/dL"],"whoShouldSkip":["For participants with relapsed or refractory multiple myeloma:","Central Nervous System (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma. If either is suspected, brain magnetic resonance imaging (MRI) and lumbar cytology are required","Active plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis","Received a cumulative dose of corticosteroids equivalent to greater than (\\>) 140 mg of prednisone within the 14-day period before the start of study treatment administration","Prior allogeneic transplant within 6 months before the start of study treatment administration or autologous transplant within 12 weeks before the start of study treatment administration","Live, attenuated vaccine within 4 weeks before the first dose of study treatment","Non-hematologic toxicity from prior anticancer therapy that has not resolved to baseline levels or to Grade less than or equal to (\\<=) 1 (except alopecia, tissue post-RT fibrosis \\[any grade\\] or peripheral neuropathy to Grade \\<=3)"],"whatHappens":"If you join, the listed intervention(s) are JNJ-79635322. The registry lists allocation as randomized. The primary purpose of this study is to identify the recommended phase 2 dose (RP2D\\[s\\]) and schedule(s) to be safe for JNJ-79635322 in Part 1 (dose escalation), and to characterize the whether it is safe and how hard side effects are to live with of JNJ-79635322 at the RP2D(s) selected and in disease subgroups in Part 2 (dose expansion).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 180 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.518Z"},{"nctId":"NCT05663710","title":"Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC","officialTitle":"Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).","conditions":["Advanced Cancer","Clear Cell Renal Cell Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"177Lu girentuximab"},{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Cabozantinib"},{"type":"DRUG","name":"ArabinoFuranosylGuanine [18F]F-AraG"}],"enrollment":100,"startDate":"2023-06-30","completionDate":"2027-10-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515\n2. Age ≥ 18 years\n3. Has locally advanced or metastatic RCC with predominantly clear cell subtype\n4. Has at least one measurable lesion as defined by RECIST version 1.1\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n6. Has adequate organ function defined as follows:\n\n   a. Absolute neutrophil count ≥ 1,500/µL, Hgb level ≥ 9 g/dL and platelet count (Plt) i. ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL/min/1.73m2 c. Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease\n7. Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration\n8. Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration. Highly effective contraception methods include the following:\n\n   1. Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),\n   2. Male or female sterilization, or\n\n   Use of at least one of the following:\n\n   Use of oral, injectable, transdermal, intravaginal, or implantable hormonal methods of contraception i. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation ii. Progestogen-only hormonal contraception associated with inhibition of ovulation c. Placement of an intrauterine device or intrauterine system\n9. Able to swallow oral medications\n10. Able to provide tumor tissue sample (archival or recent acquisition)\n11. Patients with brain metastases are eligible providing other measurable disease exists and brain lesions are controlled for one month (requiring no therapy) and are not life threatening.\n\nExclusion Criteria:\n\n1. Has received treatment with any frontline systemic therapy for metastatic RCC\n2. Has a history of leptomeningeal disease or spinal cord compression\n3. Has a history of autoimmune disease requiring active therapy\n4. Has a history of brain metastases except:\n\n   1. Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND\n   2. Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs\n5. Has had radiation therapy for bone metastases within 2 weeks, or any other external radiation therapy (5 days or longer) to sites other than bone, within 4 weeks before administration of the first dose of study treatment. Patients with clinically relevant ongoing major complications from prior radiation therapy are not eligible.\n6. Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \\> 140/90 with or without antihypertensive treatment\n7. Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, pulmonary embolism, clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure\n8. Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the opinion of the investigator or medical monitor\n9. Has an active infection requiring systemic treatment\n10. Is participating in another therapeutic clinical trial\n11. Is receiving chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors\n12. Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease\n13. Has GI disorders including those associated with a high risk of perforation or fistula formation:\n\n    1. Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or biliary duct, or gastric outlet obstruction\n    2. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before administration of the first dose of study treatment. Note: complete healing of an intra-abdominal abscess must be confirmed before administration of the first dose of study treatment\n14. Has tumor invading or encasing any major blood vessels\n15. Has other clinically significant disorders such as:\n\n    1. Serious non-healing wound/ulcer/bone fracture\n    2. Moderate to severe hepatic impairment (Child-Pugh B or C).\n    3. Requirement for hemodialysis or peritoneal dialysis\n    4. History of solid organ transplantation\n16. Has had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 2 months before the first study drug administration. Complete wound healing from major surgery must have occurred 1 month before the first study drug administration and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the first study drug administration. Patients with clinically relevant ongoing complications from prior surgery are not eligible\n17. Has a prior or concomitant invasive malignancy other than RCC with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the patient has remained disease free for more than 2 years.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric Jonasch, MD","phone":"(713) 563-7232","email":"ejonasch@mdanderson.org"}],"primaryOutcomes":["Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing 177Lu girentuximab for Advanced Cancer","inPlainEnglish":"To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).","whoItsFor":["Ages 18 Years to any","Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515","Has locally advanced or metastatic RCC with predominantly clear cell subtype","Has at least one measurable lesion as defined by RECIST version 1.1","Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1","Has adequate organ function defined as follows:","Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration","Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),"],"whoShouldSkip":["Has received treatment with any frontline systemic therapy for metastatic RCC","Has a history of leptomeningeal disease or spinal cord compression","Has a history of autoimmune disease requiring active therapy","Has a history of brain metastases except:","Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND","Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs","Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \\> 140/90 with or without antihypertensive treatment"],"whatHappens":"If you join, the listed intervention(s) are 177Lu girentuximab, Nivolumab, or Cabozantinib. The registry lists allocation as randomized. To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.933Z"},{"nctId":"NCT05663775","title":"Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)","officialTitle":"Prophylactic Oral Mesalamine for the Prevention of Immune-Related Colitis in Patients Treated With Ipilimumab/Nivolumab","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AHS Cancer Control Alberta","sponsorClass":"OTHER","summary":"The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?\"","conditions":["Immune-related Adverse Event","Diarrhea","Advanced Melanoma","Advanced Rectal Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mesalamine"}],"enrollment":20,"startDate":"2024-08-20","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients must be 18 years of age or older.\n2. Patients with histologically confirmed, unresectable stage III or IV malignant melanoma.\n3. Patients must be capable of providing consent to enrolment and treatment.\n4. Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1).\n5. Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy or bilateral salpingectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \\> 40 mIU/mL to confirm menopause.\n6. Patients of childbearing / reproductive potential should use highly effective birth control methods, as defined by the investigator, during the study treatment period and for a period of 30 days after the last dose of study drug. A highly effective method of birth control is defined as those that result in low failure rate (i.e. less than 1% per year) when used consistently and correctly.\n\n   -Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard.\n7. Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug.\n8. Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug\n9. Absence of any condition hampering compliance with the study protocol and follow- up schedule; those conditions should be discussed with the patient before registration in the trial.\n\n   * The following adequate organ function laboratory values must be met:\n\nHematological:\n\n* Absolute neutrophil count (ANC) \\>1.5 x109/L\n* Platelet count \\>100 x109/L\n* Hemoglobin \\>9 g/dL (may have been transfused)\n\nRenal:\n\no Estimated creatinine clearance ≥ 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method)\n\nHepatic:\n\n* Total serum bilirubin \\<2x ULN\n* AST and ALT \\<2.5x ULN (or ≤ 5 x ULN for subjects with documented metastatic disease to the liver)\n\nExclusion Criteria:\n\n1. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\\< 6 months prior to enrollment), myocardial infarction (\\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n2. Current use of immunosuppressive medication, EXCEPT for the following: a. intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection); b. Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; c. Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).\n3. Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3).\n4. Other severe acute or chronic medical conditions or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.","locations":[{"facility":"Cross Cancer Institute","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of Treatment Related Diarrhea","Severity of Treatment Related Diarrhea","Causality of Treatment Related Diarrhea"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["nivolumab"],"locationSlugs":["edmonton-canada"],"enrichment":{"headline":"Phase 2: testing Mesalamine for Immune-related Adverse Event","inPlainEnglish":"The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?\"","whoItsFor":["Ages 18 Years to any","Patients must be 18 years of age or older","Patients with histologically confirmed, unresectable stage III or IV malignant melanoma","Patients must be capable of providing consent to enrolment and treatment","Patients with a performance status of ECOG 0-224 will be eligible for enrolment (see appendix16.1)","Note: abstinence is acceptable if this is established and preferred contraception for the patient and is accepted as a local standard","Female patients who are breast-feeding should discontinue nursing prior to the first dose of study treatment and until 30 days after the last dose of study drug","Male patients should agree to not donate sperm during the study and for a period of at least 30 days after last dose of study drug"],"whoShouldSkip":["Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE v5 Grade ≥ 3)"],"whatHappens":"If you join, the listed intervention(s) are Mesalamine. The registry lists allocation as na. The study team's principal interest is to address the question, \"Will prophylactic treatment with mesalamine reduce the incidence and severity of immune-related diarrhea occurring secondarily to treatment with ipi/nivo?\"","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.807Z"},{"nctId":"NCT05665361","title":"Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)","officialTitle":"A Phase I/II Study of Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nKidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments. Better treatments are needed.\n\nObjective:\n\nTo test a pair of drugs (sasanlimab and palbociclib) in people with kidney cancers.\n\nEligibility:\n\nPeople aged 18 years and older with kidney cancer; specifically, clear cell renal cell carcinoma (ccRCC) or papillary renal cell carcinoma (pRCC).\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have an imaging scan and a test of their heart function. They may have a biopsy; that is, a sample of tissue will be cut from the tumor.\n\nParticipants will be treated in 28-day cycles for up to 2 years.\n\nPalbociclib is a pill taken by mouth. Participants will take this drug once a day for 21 days during each 28-day treatment cycle. They will write down the dates and times they take these pills in a diary.\n\nSasanlimab is an injection under the skin. Participants will receive this injection on the first day of each treatment cycle.\n\nImaging scans and blood tests will be repeated throughout the treatment. Tumor biopsies may be repeated up to 3 times; these biopsies are optional.\n\nParticipants will have follow-up visits every month for 3 months after treatment ends. They will continue to have imaging scans every 3 months; these scans may be done close to home. The results can be sent to researchers.\n\nParticipants will remain in the study up to 6 years.","conditions":["Advanced Clear Cell Renal Carcinoma (Ccrcc)","Papillary Renal Cell Carcinoma (Prcc)"],"keywords":["Papillary Renal Cell Carcinoma","Kidney Neoplasms","Kidney Cancer","Clear Cell Renal Cell Carcinoma","Translocation Renal Cell Carcinoma","TFE3-rearranged renal cell cancer"],"interventions":[{"type":"DRUG","name":"Sasanlimab"},{"type":"DRUG","name":"Palbocicilib"}],"enrollment":100,"startDate":"2024-04-24","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)\n* Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.\n* Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)\n* Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC\n* Age \\>= 18 years\n* ECOG performance status \\<= 1\n* Adequate hematologic function at screening, as follows:\n\n  * Absolute neutrophil count (ANC) \\>= 1,000/microliter\n  * Hemoglobin (Hb) \\>= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation\n  * Platelets \\>= 100,000/microliter\n* Adequate renal and hepatic function at screening, as follows:\n\n  * Serum creatinine \\<= 1.5 x upper limit of normal (ULN) OR, if \\>1.5x ULN, creatinine clearance (CrCl) \\>= 30 mL/min/1.73 m\\^2 (calculated CrCl (CKD-EPI or calculated eGFR provided by laboratory))\n  * Total bilirubin \\<= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \\<= 3.0 x ULN\n  * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<= 2.5 x ULN, (unless liver metastases are present, then values must be \\<= 5 x ULN)\n* Participants serologically positive for hepatitis C virus (HCV) are eligible if HCV viral load is undetectable\n* Participants serologically positive for human immunodeficiency virus (HIV) are eligible if they are on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic infections or Castleman s disease within 12 months prior to treatment initiation, have a viral load that is undetectable by quantitative polymerase chain reaction (PCR) and CD4 count \\>= 200 cells per cubic millimeter\n* Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms\n* Women of child-bearing potential (WOCBP) must agree to use one (1) highly effective method of contraception (e.g.,hormonal, intrauterine device (IUD), surgical sterilization) prior to study entry, for the duration of study therapy, and for up to 6 months following the last dose of any study agent(s). Women must refrain from donating eggs during this same period. NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n* Men with female partners of reproductive potential and pregnant partners are required to use a condom (even after vasectomy), during treatment and for at least 6 months after the final dose and must refrain from donating sperm during this same period.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study enrollment through 6 months after study treatment discontinuation\n* Participants must be able to understand and be willing to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation\n* More than four prior lines of systemic therapy in the metastatic setting\n* Participants who have wound dehiscence from prior surgeries\n* Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents\n* Prior history of grade \\>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible\n* An active autoimmune disease. Note: participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\\<= the equivalent of prednisone 10 mg/day) or other mild autoimmune disorders not requiring immunosuppressive treatment are eligible.\n* Participants receiving systemic corticosteroids at doses equivalent \\> 10 mg/daily of prednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, sirolimus, thalidomide, or anti-tumor necrosis factor \\[anti-TNF\\] agents. Note: participants on steroids through a route known to result in minimal systemic exposure (topical, intranasal, intro-ocular, or inhalation) are eligible\n* Prior allogeneic/autologous bone marrow or solid organ transplant\n* Participants with current or past hepatitis B (HBV) infection\n* Participants with a history of interstitial lung disease, non-infectious pneumonitis, or untreated active/latent pulmonary tuberculosis (TB)\n* Participants taking medications that are strong inhibitors or inducers of CYP3A (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions-table-substrates-inhibitors-and-inducers#table3-2) within 21 days or 5 half-lives of the agent (whichever is shorter) prior to initiation of study therapy\n* Participants taking any herbal supplements within 14 days prior to initiation of study therapy\n* History of a non RCC malignancy within 2 years of treatment initiation except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder cancer, or other malignancy which does not require treatment at the current time per Standard of Care\n* Pregnant women (confirmed by beta-HCG serum pregnancy test performed at screening)\n* Uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wanda A Bell-Farrell","phone":"(240) 858-7768","email":"wanda.bell-farrell@nih.gov"},{"name":"Ramaprasad Srinivasan, M.D.","phone":"(240) 760-6251","email":"ramasrin@mail.nih.gov"}],"primaryOutcomes":["Phase I: To determine RP2D of palbociclib in combination with sasanlimab","Phase II: Objective response rate (ORR)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Sasanlimab for Advanced Clear Cell Renal Carcinoma (Ccrcc)","inPlainEnglish":"Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments.","whoItsFor":["Ages 18 Years to 100 Years","Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)","Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1","Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)","Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC","how well you can do daily activities (ECOG score) \\<= 1","Adequate hematologic function at screening, as follows:","Absolute neutrophil count (ANC) \\>= 1,000/microliter"],"whoShouldSkip":["Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment initiation","More than four prior lines of systemic therapy in the metastatic setting","Participants who have wound dehiscence from prior surgeries","Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib","History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents","Prior history of grade \\>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible","Prior allogeneic/autologous bone marrow or solid organ transplant"],"whatHappens":"If you join, the listed intervention(s) are Sasanlimab, or Palbocicilib. The registry lists allocation as randomized. Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.721Z"},{"nctId":"NCT05667142","title":"A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Xenon Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).","conditions":["Primary Generalized Tonic-Clonic Seizures"],"keywords":["Epilepsy"],"interventions":[{"type":"DRUG","name":"XEN1101"},{"type":"DRUG","name":"Placebo"}],"enrollment":160,"startDate":"2023-02-14","completionDate":"2027-04","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.\n2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.\n3. Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom.\n4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).\n5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned randomization (Visit 2), during screening/baseline, and throughout the DBP.\n6. Subject is able to keep accurate seizure diaries.\n\nKey Exclusion Criteria:\n\n1. Subject has had status epilepticus within the 12 months prior to Visit 1.\n2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.\n3. Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.\n4. Subject has a concomitant diagnosis of focal-onset seizures (FOS).\n5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.\n6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease.\n7. Subject has history of neurosurgery for seizures \\<1 year prior to Visit 1, or radiosurgery \\<2 years prior to Visit 1.\n8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.\n9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:\n\n   a. History or presence of long QT syndrome; QTcF \\>450 msec at baseline; family history of sudden death of unknown cause.\n10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.\n\nThe criteria to be eligible for randomization are:\n\n1. During the last 56 days that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization. Retrospective seizure data documented up to 4 weeks prior to Visit 1 may be used in combination with a minimum of 4 weeks of prospective seizure data recorded in the study eDiary.\n2. Study eDiary was completed a minimum of 80% of all applicable days during the last 28-56 days of the baseline period that preceded randomization as evidence of adequate compliance (eg, \\>45 of 56 days, if no retrospective data prior to Visit 1 are used).\n3. Subject did not change dose of, stop, or initiate any new ASM(s) during the 3 months that preceded randomization and plans on maintaining a stable dose of ASM(s) during the DBP.","locations":[{"facility":"University of Alabama - Strada Patient Care Center, Neurology","city":"Mobile","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Xenoscience","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona - Health Science Center","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brain Science Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine - Health Neurology Services","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)","city":"Sacramento","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Serenity Research Center, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Neuroscience Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute of Orlando, LLC","city":"Orlando","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Panhandle Research and Medical Clinic","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medsol Clinical Research Center Harbor Professional Centre","city":"Port Charlotte","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research of Weston, LLC","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Brain Health Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georgia Neurology & Sleep Medicine Associates","city":"Suwanee","state":"Georgia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Consultants in Epilepsy and Neurology, PLLC","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois University School of Medicine","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bluegrass Epilepsy Research, LLC","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky Albert B. Chandler Hospital (UK Healthcare)","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Franklin Square Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-Atlantic Epilepsy and Sleep Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medstar Georgetown University Hospital","city":"Clinton","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Chestnut Hill","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMass Memorial Medical Center","city":"Worcester","state":"Massachusetts","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Michigan Hospitals","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wayne State University","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan State University Department of Neurology","city":"East Lansing","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Health","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Louis University Medical School","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boys Town National Research Hospital","city":"Boys Town","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Regional Epilepsy Group","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dent Neurosciences Research Facility","city":"Amherst","state":"New York","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"SUNY Upstate Medical University","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Five Towns Neurology","city":"Woodmere","state":"New York","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Atrium Health","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions, LLC","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Clinical Research","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest Baptist Health","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summa Health Clinical Research Center","city":"Akron","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OhioHealth Riverside Methodist Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"UPMC Comprehensive Epilepsy Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina (MUSC)","city":"Charleston","state":"South Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Child Neurology & Consultants of Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ANESC Research","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Clinical Neurosciences Center","city":"Salt Lake City","state":"Utah","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sentara Neurology Specialists","city":"Virginia Beach","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington, Regional Epilepsy Center at Harborview Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advocate Aurora Research institute, St. Luke's Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Hospital General de Agudos J.M. 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Greater Manchester Neuroscience Centre (GMNC)","city":"Salford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xenon Medical Affairs","phone":"1-604-484-3300","email":"XenonCares@xenon-pharma.com"}],"primaryOutcomes":["Median percent change (MPC) in monthly (28 days) PGTCS frequency"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["mobile-alabama","phoenix-arizona","tucson-arizona","little-rock-arkansas","los-angeles-california","orange-california","sacramento-california","aurora-colorado","jacksonville-florida","miami-florida","orlando-florida","pensacola-florida","port-charlotte-florida","tampa-florida","weston-florida","atlanta-georgia","suwanee-georgia","honolulu-hawaii","boise-idaho","springfield-illinois","indianapolis-indiana","kansas-city-kansas","lexington-kentucky","baltimore-maryland","bethesda-maryland","clinton-maryland","chestnut-hill-massachusetts","worcester-massachusetts","ann-arbor-michigan","detroit-michigan","east-lansing-michigan","grand-rapids-michigan","st-louis-missouri","boys-town-nebraska","hackensack-new-jersey","amherst-new-york","syracuse-new-york","woodmere-new-york","charlotte-north-carolina","durham-north-carolina","winston-salem-north-carolina","akron-ohio","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","charleston-south-carolina","austin-texas","el-paso-texas","houston-texas","san-antonio-texas","salt-lake-city-utah","virginia-beach-virginia","seattle-washington","milwaukee-wisconsin","buenos-aires-argentina","san-miguel-de-tucum-n-argentina","kogarah-australia","south-brisbane-australia","melbourne-australia","heidelberg-australia","parkville-australia","innsbruck-austria","linz-austria","salzburg-austria","vienna-austria","brussels-belgium","ghent-belgium","blagoevgrad-bulgaria","sofia-bulgaria","lethbridge-canada","vancouver-canada","london-canada","montreal-canada","santiago-chile","osijek-croatia","rijeka-croatia","zagreb-croatia","prague-czechia","lille-france","lyon-france","paris-france","rennes-france","strasbourg-france","aachen-germany","berlin-germany","bielefeld-germany","frankfurt-germany","freiburg-im-breisgau-germany","marburg-germany","m-nchen-germany","radeberg-germany","t-bingen-germany","ulm-germany","jerusalem-israel","ramat-gan-israel","rehovot-israel","tel-aviv-israel","ancona-italy","chieti-italy","pisa-italy","roma-italy","mexico-city-mexico","sinaloa-mexico","heeze-netherlands","bydgoszcz-poland","gdansk-poland","katowice-poland","lublin-poland","nowa-s-l-poland","coimbra-portugal","guimar-es-portugal","lisbon-portugal","matosinhos-municipality-portugal","porto-portugal","santa-maria-da-feira-portugal","madrid-spain","m-laga-spain","valladolid-spain","valpara-so-spain","cardiff-united-kingdom","wakefield-united-kingdom","london-united-kingdom","oxford-united-kingdom","salford-united-kingdom"],"enrichment":{"headline":"Phase 3: testing XEN1101 for Primary Generalized Tonic-Clonic Seizures","inPlainEnglish":"This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).","whoItsFor":["Ages 12 Years to any","Subject is ≥12 years of age with a body-mass index (BMI) ≤40 kg/m2 at Visit 1","Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom","Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned randomization (Visit 2), during screening/baseline, and throughout the DBP","Subject is able to keep accurate seizure diaries"],"whoShouldSkip":["Subject has had status epilepticus within the 12 months prior to Visit 1","Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted","Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1","Subject has a concomitant diagnosis of focal-onset seizures (FOS)","Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome","Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease","Subject has history of neurosurgery for seizures \\<1 year prior to Visit 1, or radiosurgery \\<2 years prior to Visit 1"],"whatHappens":"If you join, the listed intervention(s) are XEN1101, or Placebo. The registry lists allocation as randomized. This is a Phase 3, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the clinical how well it works, safety, and tolerability of XEN1101 administered as added on top of your current treatment treatment in primary generalized tonic-clonic seizures (PGTCS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 160 people at 141 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.906Z"},{"nctId":"NCT05669703","title":"NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder","officialTitle":"NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipolar Disorder","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nMood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances. In this natural history study, researchers would like to learn more about the connection between exercise and mental health in people with and without mood disorders.\n\nObjective:\n\nTo better understand relationships among physical activity, sleep, and mental health.\n\nEligibility:\n\nPeople aged 8 to 60 years with a history of a mood disorder. Healthy spouses and relatives with no mood disorders are also needed.\n\nDesign:\n\nParticipants will be in the study up to 2 years.\n\nFor up to 20 days in a row, at 4 times during the study, participants will:\n\nComplete an electronic diary on their smartphone. Participants will answer questions about their mood, health, sleep, and daily activities.\n\nWear an activity monitor, like a wristwatch, that records how much they move.\n\nWear a light sensor, as a necklace, to record the amount of light in their environment.\n\nSome participants will do additional tests. Twice during the study, for 3 days in a row, they will:\n\nWear monitors to record their temperature, heart rate, and sleep.\n\nProvide saliva samples.\n\nComplete cognitive tasks on their smartphone.\n\nParticipants will visit the NIH clinic 2 times. They will have a physical exam, with blood and urine tests. They will wear a heart monitor. They will ride a stationary bike for 30 minutes. They may have an imaging scan.\n\nSome participants will stay overnight. They will go to sleep wearing a cap to measure their brain activity.","conditions":["Bipolar Disorder","Major Depression","Migraine"],"keywords":["Mood Disorders","Actigraphy","CIRCADIAN RHYTHMS","Sleep","Ecological Momentary Assessments","Natural History"],"interventions":[],"enrollment":1260,"startDate":"2023-11-03","completionDate":"2027-07-31","sex":"ALL","minAge":"8 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 8 and older\n3. Probands must have at least one first-degree relative agree to participate\n4. Affected probands must have a lifetime history of a mood disorder\n5. Unaffected probands must have no lifetime history of a mood disorder\n6. In good general health as evidenced by medical history\n7. Agreement to adhere to Lifestyle Considerations throughout study duration\n8. Ability of subject (or Legally Authorized Representative (LAR)) to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nThe presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy\n2. People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathleen R Merikangas, Ph.D.","phone":"(301) 496-7773","email":"familystudy@nih.gov"}],"primaryOutcomes":["Scores on standardized questionnaires","Subjective mood and energy ratings","Clinical rating scales"],"hasResults":false,"conditionSlugs":["migraine","als","depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"NIMH Rhythms and Blues Study: A Prospective Natural History Study of Motor Activity, Mood States, and Bipol…","inPlainEnglish":"Background: Mood disorders, such as bipolar disorder, can have serious effects on a person s life. People with bipolar disorder are more likely to have heart disease and abuse substances.","whoItsFor":["Ages 8 Years to 70 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availability for the duration of the study","Probands must have at least one first-degree relative agree to participate","Affected probands must have a lifetime history of a mood disorder","Unaffected probands must have no lifetime history of a mood disorder","In good general health as evidenced by medical history","Agreement to adhere to Lifestyle Considerations throughout study duration"],"whoShouldSkip":["The presence of certain medical conditions may interfere with the interpretation or increase risk of medical complications of the assessments including exercise. Therefore, an individual who meets any of the following criteria will be excluded from participation in this study:","People in acute episodes of mania or depression (not excluded, but will delay study entry until sufficiently managed to allow participation in study procedures)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,260 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.744Z"},{"nctId":"NCT05672147","title":"CD33-CAR T Cell Therapy for the Treatment of Recurrent or Refractory Acute Myeloid Leukemia","officialTitle":"Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a Cd33-Specific Chimeric Antigen Receptor for Patients With Cd33+ Relapsed/Refractory Acute Myeloid Leukemia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's or donor's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.","conditions":["Acute Myeloid Leukemia","Recurrent Adult Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia","Secondary Acute Myeloid Leukemia"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Anti-CD33 CAR T-cells"},{"type":"PROCEDURE","name":"Lymphodepletion Therapy"}],"enrollment":27,"startDate":"2023-12-07","completionDate":"2031-09-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n  * For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening, while the request for a translated full consent is processed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with Study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Karnofsky Performance Scale (KPS) \\>= 70\n* Life expectancy \\>= 16 weeks at the time of enrollment\n* Prior allogeneic transplant allowed if \\> 6 months prior to study enrollment\n* Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence\n\n  * Relapsed AML is defined as patients that had a first complete response (CR) before developing recurrent disease (increased bone marrow blasts)\n  * Refractory AML is defined as patients that have not achieved a first CR after induction chemotherapy. For patients with AML evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy\n* Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML\n\n  * CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry. Cytogenetics, flow cytometry, and molecular studies (such as FLT-3 status) will be obtained as per standard practice\n  * Research participants who are at a high risk of disease recurrence, they must have historical bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML\n* No known contraindications to lymphodepleting agents, steroids, tocilizumab and/or cetuximab, or the investigational agent\n* Total serum bilirubin =\\< 2.0 mg/dL\n* Participants with Gilbert syndrome may be included if their total bilirubin is =\\< 3.0\n* Aspartate aminotransferase (AST) =\\< 3 x the upper limit of normal (ULN)\n* Alanine aminotransferase (ALT) =\\< 3 x ULN\n* Estimated creatinine clearance of \\>= 60 mL/min per the Cockcroft-Gault formula, and the participant is not on hemodialysis\n* Left ventricular ejection fraction \\>= 50% within 8 weeks before enrollment\n* Oxygen (O2) saturation \\> 92% not requiring oxygen supplementation\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Research participants must have a potential donor or stem cell source identified for allogeneic transplantation, either related (7/8 or 8/8 allele matched or haploidentical)\n* DONOR: The identified donor must be the original donor whose stem cells were used for the research participant's allogeneic hematopoietic stem cell transplantation (alloSCT)\n* DONOR: The donor must be HIV negative\n* DONOR: KPS \\>= 70\n* DONOR: Documented body weight\n\nExclusion Criteria:\n\n* Prior allogeneic transplant if \\< 6 months prior to enrollment\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications should be stopped 28-days prior to enrollment. Recent or current use of inhaled or topical steroids in standard doses is not exclusionary. Physiologic replacement of steroids (prednisone =\\< 7.5 mg/day, or equivalent doses of other corticosteroids) is allowed\n* Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment\n* Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy\n\n  * With exception to Hydrea which must be stopped prior to initiation of lymphodepletion\n* Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible\n\n  * Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis\n* Subjects with \\>= Grade 2 myelofibrosis on bone marrow biopsy\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening if the patient is undergoing leukapheresis. Patients with controlled atrial arrythmia is allowed\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* Subjects with presence of other active malignancy, however, research participants with history of prior malignancy treated with curative intent and in complete remission are eligible\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection based on testing performed within 4 weeks of enrollment\n* Active viral hepatitis\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Participants who achieve measurable residual disease (MRD)","Incidence of dose-limiting toxicities and full toxicity profile"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":["car-t"],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Anti-CD33 CAR T-cells for Acute Myeloid Leukemia","inPlainEnglish":"This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory). CAR T-cell therapy is a type of treatment in which a patient or donor's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells.","whoItsFor":["Ages 18 Years to any","Assent, when appropriate, will be obtained per institutional guidelines","Agreement to allow the use of archival tissue from diagnostic tumor biopsies","If unavailable, exceptions may be granted with Study principal investigator (PI) approval","Karnofsky Performance Scale (KPS) \\>= 70","Life expectancy \\>= 16 weeks at the time of enrollment","Prior allogeneic transplant allowed if \\> 6 months prior to study enrollment","Participant must have a confirmed diagnosis of active CD33+ AML de novo, or secondary OR participants who are at a high risk for disease recurrence"],"whoShouldSkip":["Prior allogeneic transplant if \\< 6 months prior to enrollment","Participants with active autoimmune disease, including graft versus host disease (GvHD), requiring systemic immune suppressive should be stopped 28-days prior to enrollment","Participants may not be receiving any other investigational agents and are not dependent on concurrent biological therapy, chemotherapy, or radiation therapy","With exception to Hydrea which must be stopped prior to initiation of lymphodepletion","Research participants on active systemic antifungal treatment within 8 weeks of enrollment are not eligible. However, participants on antifungal prophylaxis are eligible","Not applicable at the time of enrollment if the research participant's donor is undergoing leukapheresis","Subjects with \\>= Grade 2 myelofibrosis on bone marrow biopsy"],"whatHappens":"If you join, the listed intervention(s) are Anti-CD33 CAR T-cells, or Lymphodepletion Therapy. The registry lists allocation as na. This phase I trial tests the safety, side effects, and the best dose of anti-CD33 chimeric antigen receptor (CAR) T-Cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or does not respond to treatment (refractory).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 27 people at Duarte. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.835Z"},{"nctId":"NCT05672615","title":"Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With BCG","officialTitle":"Mood Alterations in the Patients With Non-Muscle Invasive Bladder Cancer Treated With Bacillus Calmete-Guerin","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study. Participation involves providing research blood and urine samples prior to the start of treatment and throughout the treatment course. The study team will also collect participant's medical history and clinical information. Participants will be asked to complete questionnaires and daily mood diaries.","conditions":["Non-Muscle Invasive Bladder Cancer"],"keywords":["Bacillus Calmette-Guerin","Mood Alterations"],"interventions":[{"type":"OTHER","name":"Questionnaires"},{"type":"OTHER","name":"Daily Mood Diaries"},{"type":"OTHER","name":"Urine Specimen Collection"},{"type":"OTHER","name":"Research Blood Draw"},{"type":"OTHER","name":"Utilize excess tissue from a standard of care procedure"}],"enrollment":42,"startDate":"2023-03-21","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects with a pathologically confirmed non-muscle invasive bladder cancer\n* Age ≥ 18 years old\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment.\n* Patients who are pregnant","locations":[{"facility":"Sibley Memorial Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Domani Rodriguez","phone":"2026605561","email":"drodri59@jh.edu"},{"name":"Armine Smith, MD","phone":"202-660-5561","email":"asmit165@jhmi.edu"}],"primaryOutcomes":["Change in cytokine response as assessed by urine samples","Change in cytokine response as assessed by blood samples","Screening for Mood Disorders utilizing the Zung Self Rating Depression Scale"],"hasResults":false,"conditionSlugs":["bladder-cancer","als"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia"],"enrichment":{"headline":"Not a traditional drug phase: Questionnaires for Non-Muscle Invasive Bladder Cancer","inPlainEnglish":"This study wants to evaluate mood changes in patients with Non-Muscle Invasive Bladder Cancer who are receiving intravesical Bacillus Calmete-Guerin (BCG). Patients with Non-Muscle Invasive Bladder Cancer receiving intravesical treatments are eligible to participate in this study.","whoItsFor":["Ages 18 Years to any","Subjects with a pathologically confirmed non-muscle invasive bladder cancer"],"whoShouldSkip":["Patients that are not candidates for intravesical treatment due to the nature of their disease, such as variant histology or progressive disease after a prior course of intravesical treatment","Patients who are pregnant"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 42 people at Washington D.C.. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.303Z"},{"nctId":"NCT05675410","title":"A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab","officialTitle":"A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.","conditions":["Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"BIOLOGICAL","name":"Bleomycin Sulfate"},{"type":"DRUG","name":"Brentuximab Vedotin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Dacarbazine"},{"type":"DRUG","name":"Doxorubicin Hydrochloride"},{"type":"DRUG","name":"Etoposide"},{"type":"DRUG","name":"Etoposide Phosphate"},{"type":"OTHER","name":"Fludeoxyglucose F-18"},{"type":"RADIATION","name":"Involved-site Radiation Therapy"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"DRUG","name":"Prednisolone"},{"type":"DRUG","name":"Prednisone"},{"type":"DRUG","name":"Procarbazine Hydrochloride"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"DRUG","name":"Vinblastine Sulfate"},{"type":"DRUG","name":"Vincristine Sulfate"}],"enrollment":1875,"startDate":"2023-05-11","completionDate":"2031-04-28","sex":"ALL","minAge":"5 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must be 5 to 60 years of age at the time of enrollment\n* Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \\[NOS\\]) with stage I or II disease\n* Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \\>= 1.5 cm)\n* Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained\n* Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.\n\n  * Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.\n* Patients \\>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2\n* Patients =\\< 17 years of age must have a Lansky performance score of \\>= 50\n* Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):\n\n  * 2 to \\< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)\n  * 6 to \\< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)\n  * 10 to \\< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)\n  * 13 to \\< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)\n  * \\>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \\>= 50 mL/min/1.73 m\\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \\>= 50 mL/min/1.73 m\\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility\n* For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \\>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight\n* Total bilirubin =\\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Aspartate aminotransferase (AST) =\\< 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Alanine aminotransferase (ALT) =\\< 3 x ULN (within 28 days prior to enrollment)\n\n  * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome\n* Shortening fraction of \\>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \\>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)\n* Diffusion capacity of the lung for carbon monoxide (DLCO) \\>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \\> 92% on room air\n* Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\nExclusion Criteria:\n\n* Patients with nodular lymphocyte predominant Hodgkin lymphoma\n* Patients with a history of active interstitial pneumonitis or interstitial lung disease\n* Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients\n* Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills\n* Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \\> 10 mg daily predniSONE for patients \\>= 18 years or \\> 0.5 mg/kg \\[up to 10 mg/day\\] for patients \\< 18 years) or other immunosuppressive medications within 14 days prior to enrollment\n\n  * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\\< 10 mg daily for patients \\>= 18 years or =\\< 0.5 mg/kg \\[up to 10 mg/day\\] predniSONE equivalents) are permitted in the absence of active autoimmune disease\n  * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1\n  * Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.\n* Patients with peripheral neuropathy \\> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome\n* Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL\n* Prior solid organ transplant\n* Prior allogeneic stem cell transplantation\n* Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \\[BCG\\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted\n* Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential\n* Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment\n* Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer\n\n  * Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin\n  * WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab\n* All patients and/or their parents or legal guardians must sign a written informed consent\n* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met","locations":[{"facility":"Children's Hospital of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA Health Strada Patient Care Center","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTCA at Western Regional Medical Center","city":"Goodyear","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner Children's at Desert","city":"Mesa","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoenix Childrens Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Children's Hospital","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Carmichael","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy San Juan Medical Center","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Corona","city":"Corona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health Cancer Center-Newport","city":"Costa Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Downey Medical Center","city":"Downey","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Elk Grove","city":"Elk Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fresno","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Seacliff","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Antelope Valley","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University Medical Center","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miller Children's and Women's Hospital Long Beach","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Long Beach Elm","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Children's Hospital","city":"Madera","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kaiser Permanente-Modesto","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Newport Beach","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United 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3: testing Bleomycin Sulfate for Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8","inPlainEnglish":"This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates.","whoItsFor":["Ages 5 Years to 60 Years","Patients must be 5 to 60 years of age at the time of enrollment","Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \\[NOS\\]) with stage I or II disease","Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \\>= 1.5 cm)","Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained","Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease","Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality","Patients \\>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2"],"whoShouldSkip":["Patients with nodular lymphocyte predominant Hodgkin lymphoma","Patients with a history of active interstitial pneumonitis or interstitial lung disease","Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients","Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills","Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1","Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids","Patients with peripheral neuropathy \\> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bleomycin Sulfate, or Brentuximab Vedotin. The registry lists allocation as randomized. This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,875 people at 419 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.004Z"},{"nctId":"NCT05677490","title":"mFOLFIRINOX Versus mFOLFOX With or Without Nivolumab for the Treatment of Advanced, Unresectable, or Metastatic HER2 Negative Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinoma","officialTitle":"Randomized Phase III Trial of mFOLFIRINOX vs. FOLFOX With Nivolumab for First-Line Treatment of Metastatic HER2- Gastroesophageal Adenocarcinoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alliance for Clinical Trials in Oncology","sponsorClass":"OTHER","summary":"This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy. The usual approach is defined as care most people get for cancer in the stomach, esophagus, or gastroesophageal junction. Fluorouracil is in a class of medications called antimetabolites. It stops cells from making DNA and may kill tumor cells. Leucovorin in a class of medications called folic acid analogs. When used with fluorouracil it enhances the effects of this chemotherapy drug. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and DNA repair, and may kill cancer cells. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill cancer cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Some patients on this trial will receive nivolumab, in addition to mFOLFOX or mFOLFIRINOX chemotherapy. mFOLFIRINOX with or without nivolumab may be more effective than mFOLFOX with or without nivolumab by shrinking the tumor in patients with advanced, unresectable, or metastatic HER2-negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.","conditions":["Advanced Esophageal Adenocarcinoma","Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Esophageal Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Esophageal Adenocarcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Unresectable Esophageal Adenocarcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Fluorouracil"},{"type":"DRUG","name":"Leucovorin Calcium"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Irinotecan"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":382,"startDate":"2023-01-31","completionDate":"2028-11-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologic documentation: HER2 negative adenocarcinoma as defined by American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Bartley et al., Journal of Clinical Oncology \\[JCO\\] 2017) with known PD-L1 combined positive score (CPS) (any CPS is allowed, but should be known prior to registration)\n* Stage: unresectable or metastatic\n* Tumor site: esophagus, gastroesophageal junction, or stomach\n* Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* No prior systemic treatment for unresectable or metastatic disease\n* Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n\n  \\* Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\< 7 days prior to registration is required\n* Age \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1\n* Absolute neutrophil count (ANC) \\>= 1,500/mm\\^3\n* Platelet count \\>= 100,000/mm\\^3\n* Creatinine =\\< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \\>= 30 mL/min\n* Total bilirubin =\\< 1.5 x ULN\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\< 3 x ULN (in patients with liver metastasis: =\\< 5 x ULN if clearly attributable to liver metastases)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients positive for human immunodeficiency virus (HIV) are eligible only if they meet all of the following:\n\n  * On effective anti-retroviral therapy\n  * Undetectable HIV viral load by standard clinical assay =\\< 6 months of registration\n* No known Gilbert's syndrome or known homozygosity for UGAT1A1\\*28 polymorphism\n* No baseline grade \\>= 2 peripheral neuropathy, neurosensory toxicity, or neuromotor toxicity per CTCAE version (v) 5.0 regardless of causality\n* No medical condition such as uncontrolled infection or uncontrolled diabetes mellitus which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No untreated, symptomatic brain metastasis. Patients with treated brain metastases are eligible if the following criteria are met: 1) follow-up brain imaging done at least in 4 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression and 2) the patient no longer requires steroids, or is on a stable steroid dose for more than four weeks\n* No allogeneic tissue/organ transplant\n* Patients who will receive nivolumab in addition to chemotherapy must not have any contraindications to immune checkpoint inhibitors\n\n  * Patients must not have active autoimmune disease that has required systemic treatment within 6 months prior to registration. Patients are permitted to receive immunotherapy if they have vitiligo, type I diabetes, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger (precipitating event)\n  * Patients must not have a condition requiring systemic treatment with either corticosteroids (\\>10mg/day prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids and adrenal replacement doses (=\\< 10mg/day prednisone equivalent) are permitted\n  * Patients must not have a history of noninfectious pneumonitis requiring steroids\n  * Patients with prior immune mediated adverse events related to immunotherapy that resulted in permanent treatment discontinuation with these agents are ineligible","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Radiation Therapy Center","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Oncology Centre","city":"Anchorage","state":"Alaska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairbanks Memorial Hospital","city":"Fairbanks","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kingman Regional Medical 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","charleston-west-virginia","antigo-wisconsin","ashland-wisconsin","burlington-wisconsin","chippewa-falls-wisconsin","cudahy-wisconsin","eau-claire-wisconsin","germantown-wisconsin","grafton-wisconsin","green-bay-wisconsin","hayward-wisconsin","kenosha-wisconsin","la-crosse-wisconsin","ladysmith-wisconsin","marinette-wisconsin","marshfield-wisconsin","medford-wisconsin","milwaukee-wisconsin","minocqua-wisconsin","mukwonago-wisconsin","neillsville-wisconsin","new-richmond-wisconsin","oconomowoc-wisconsin","oconto-falls-wisconsin","oshkosh-wisconsin","racine-wisconsin","rhinelander-wisconsin","rice-lake-wisconsin","sheboygan-wisconsin","spooner-wisconsin","stevens-point-wisconsin","sturgeon-bay-wisconsin","summit-wisconsin","superior-wisconsin","two-rivers-wisconsin","waukesha-wisconsin","wausau-wisconsin","wauwatosa-wisconsin","west-allis-wisconsin","weston-wisconsin","wisconsin-rapids-wisconsin","cheyenne-wyoming","cody-wyoming","sheridan-wyoming","bayam-n-puerto-rico","manati-puerto-rico","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 3: testing Fluorouracil for Advanced Esophageal Adenocarcinoma","inPlainEnglish":"This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma. The usual approach for patients who are not in a study is treatment with FOLFOX with some receiving an immunotherapy drug, either nivolumab or pembrolizumab, in addition to FOLFOX chemotherapy.","whoItsFor":["Ages 18 Years to any","Stage: unresectable or metastatic","Tumor site: esophagus, gastroesophageal junction, or stomach","Measurable disease or non-measurable but evaluable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1","No prior systemic treatment for unresectable or metastatic disease","Prior neoadjuvant or adjuvant cytotoxic chemotherapy or adjuvant immunotherapy is allowed as long as it was completed at least 1 year prior to registration","Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects","\\* Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done =\\< 7 days prior to registration is required"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Fluorouracil, Leucovorin Calcium, or Oxaliplatin. The registry lists allocation as randomized. This phase III trial compares the effect of modified fluorouracil, leucovorin calcium, oxaliplatin, and irinotecan (mFOLFIRINOX) with or without nivolumab to the effect of modified fluorouracil, leucovorin calcium, and oxaliplatin (mFOLFOX) with or without nivolumab for the treatment of patients with advanced, unresectable, or metastatic HER2 negative esophageal, gastroesophageal junction, or gastric adenocarcinoma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 382 people at 802 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.012Z"},{"nctId":"NCT05685628","title":"Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds","officialTitle":"Evaluation of the Quality of Life Induced by the Cinnamon Anti-odor Dressing in Patients With Malodorous Wounds: a Multicenter Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"Refer to \"Detailed description\".","conditions":["Malodorous Wounds (Chronic, Malignant or Infected Wounds)"],"keywords":["Malodorous wounds","Malignant wound","Symptom management"],"interventions":[{"type":"OTHER","name":"Cinnamon dressing"},{"type":"OTHER","name":"Charcoal dressing"}],"enrollment":98,"startDate":"2023-10-04","completionDate":"2027-04-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient \\>18 years of age with a smelly wound (discomfort \\> 4/10 expressed by the patient);\n* Predictive wound healing \\>14 days (clinical judgement);\n* Patient benefiting from a social security scheme (AME excluded)\n* Patient, and curator if applicable, informed and having signed the consent form for participation in the study\n\nExclusion Criteria:\n\n* Patient who has received a secondary charcoal or cinnamon dressing within the last 48 hours\n* Patient with pressure ulcer stage 1 or 2\n* Patient treated by metronidazole or antimicrobial for \\< 3 days;\n* Patient who cannot communicate his feelings;\n* Anosmic patient;\n* Patient with cinnamon allergy;\n* Persons deprived of their liberty or under guardianship;\n* Inability to submit to the medical follow-up of the trial for geographical, social, psychological or cognitive reasons.","locations":[{"facility":"Hôpital Henri Mondor","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospitalisation à domicile Fondation Santé Service","city":"Levallois-Perret","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospitalisation à Domicile AP-HP","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Sainte Périne","city":"Paris","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospitalisation à domicile de la région de Melun","city":"Vaux-le-Pénil","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maxime CHERON, IDE","phone":"01 44 32 42 34","email":"maxime.cheron@curie.fr"}],"primaryOutcomes":["Wound-Qol"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["cr-teil-france","levallois-perret-france","paris-france","vaux-le-p-nil-france"],"enrichment":{"headline":"Not a traditional drug phase: Cinnamon dressing for Malodorous Wounds (Chronic, Malignant or Infected Wounds)","inPlainEnglish":"This listing is written in technical language. The bullets below are the parts that matter if you are deciding whether to call the study team.","whoItsFor":["Ages 18 Years to any","Patient \\>18 years of age with a smelly wound (discomfort \\> 4/10 expressed by the patient);","Predictive wound healing \\>14 days (clinical judgement);","Patient benefiting from a social security scheme (AME excluded)","Patient, and curator if applicable, informed and having signed the consent form for participation in the study"],"whoShouldSkip":["Patient who has received a secondary charcoal or cinnamon dressing within the last 48 hours","Patient with pressure ulcer stage 1 or 2","Patient treated by metronidazole or antimicrobial for \\< 3 days;","Patient who cannot communicate his feelings;","Patient with cinnamon allergy;","Persons deprived of their liberty or under guardianship;","Inability to submit to the medical follow-up of the trial for geographical, social, psychological or cognitive reasons"],"whatHappens":"If you join, the listed intervention(s) are Cinnamon dressing, or Charcoal dressing. The registry lists allocation as randomized. ","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 98 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.648Z"},{"nctId":"NCT05696626","title":"Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","officialTitle":"An Open Label, Randomized, Multicenter Study Comparing the Efficacy and Safety of the Combination of Lasofoxifene and Abemaciclib to the Combination of Fulvestrant and Abemaciclib for the Treatment of Pre- and Postmenopausal Women and Men With Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"LeonaBio","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.\n\nThe main question the study aims to answer is:\n\n• To compare the efficacy of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.","conditions":["Metastatic Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lasofoxifene in combination with abemaciclib"},{"type":"DRUG","name":"Fulvestrant in combination with abemaciclib"}],"enrollment":600,"startDate":"2023-10-31","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Pre- or postmenopausal women or men.\n2. Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease.\n3. Histological or cytological confirmation of ER+/HER2 - disease\n4. No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer.\n5. At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue.\n6. Locally advanced or metastatic breast cancer with at least 1 measurable (according to RECIST 1.1) lesion with or without non-measurable lesions.\n7. Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy.\n8. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\n9. Adequate organ function\n10. Able to swallow tablets\n11. Brain metastases are allowed only if the following 4 parameters hold:\n\n    1. Asymptomatic,\n    2. Definitively treated (e.g., radiotherapy, surgery),\n    3. Not requiring steroids up to 4 weeks before study treatment initiation, AND\n    4. Central nervous system disease stable for \\>3 months prior to registration as documented by magnetic resonance imagining (MRI).\n12. Able to understand and voluntarily sign a written informed consent before any screening procedures.\n13. Every attempt should be made to obtain a biopsy of metastatic breast cancer tissue, when safe and feasible, to provide histological or cytological confirmation of ER+/HER2- disease as assessed by a local laboratory, according to American Society of Clinical Oncology/College of American Pathologists guidelines, using slides, paraffin blocks, or paraffin samples. If a biopsy is done, it may undergo genomic testing at some point to assess for ESR1 mutations and correlation with ctDNA results. If a biopsy is not possible or inappropriate from a clinical standpoint, the ER and HER2 status from the subject's most recent biopsy must confirm that the subject is ER+ and HER2\n\nExclusion Criteria:\n\n1. Lymphangitic carcinomatosis involving the lung.\n2. History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy.\n3. Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator.\n4. Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy.\n5. Subjects with a known hypersensitivity to fulvestrant or to any of the excipients\n6. Radiotherapy within 30 days prior to Visit 0 (Day 1) except in case of localized radiotherapy for analgesic purposes or for lytic lesions at risk of fracture, which can then be completed within 7 days prior to Visit 0 (Day 1). Subjects must have recovered from radiotherapy toxicities prior to Visit 0 (Day 1).\n7. Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)\n8. History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of \\>480 msec.\n9. History of a pulmonary embolus (PE), deep vein thrombosis (DVT), or any known thrombophilia, unless the event occurred greater than 6 months prior to screening and the subject is treated with chronic anticoagulant therapy such as apixaban (Eliquis) or rivaroxaban (Xarelto).\n10. Lasofoxifene is not recommended for use in subjects with conditions that place them at increased risk for VTEs (such as severe congestive heart failure \\[CHF\\] or prolonged immobilization).\n11. On concomitant strong CYP3A4 inhibitors.\n12. On strong and moderate CYP3A4 inducers.\n13. Any significant co-morbidity that would impact the study or the subject's safety, including subjects with significant malabsorption.\n14. Active systemic bacterial or fungal infection (requiring intravenous \\[IV\\] antibiotics or antifungals at the time of initiating study treatment).\n15. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).\n16. History of malignancy within the past 5 years (excluding breast cancer), except basal cell or squamous cell carcinoma of the skin curatively treated by surgery.\n17. Positive serum pregnancy test (only if premenopausal).\n18. Sexually active premenopausal women and men unwilling to use double-barrier contraception.\n19. Women who are breast feeding\n20. History of non-compliance to medical regimens.\n21. Unwilling or unable to comply with the protocol.\n22. Current participation in any clinical research trial involving an investigational drug or device within the last 30 days.\n23. Subjects with a history of familial hypertriglyceridemia or fasting triglyceride levels \\>880 mg/dL at screening.\n24. Fasting triglyceride level \\>300 mg/dL and ≤880 mg/dL at screening. Subjects may be retested and enrolled if they have a repeat fasting triglyceride level less than or equal to 300 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).\n25. Fasting cholesterol level \\>400 mg/dL at screening. Subjects may be retested and enrolled if they have a repeat fasting cholesterol level less than or equal to 400 mg/dL prior to enrollment (e.g., after adjustment with diet and/or treatment).","locations":[{"facility":"Mayo Clinic - Scottsdale","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona - Cancer Center","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation - Santa Rosa, CA","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute Plantation","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University School of Medicine","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Kimmel Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer and Hematology Centers of Western Michigan","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allina Health System DBA Virginia Piper Cancer Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Centre","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Jersey Cancer Care, PA","city":"Belleville","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Kaseman Hospital","city":"Albuquerque","state":"New Mexico","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Rust Cancer Center","city":"Rio Rancho","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Blavatnik Family - Chelsea Medical Center at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David H. 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Senior Vice President, Clinical Operations","phone":"(909) 374-3793","email":"clinicaltrials@leonabio.com"}],"primaryOutcomes":["Progression free survival (PFS)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["scottsdale-arizona","tucson-arizona","santa-rosa-california","jacksonville-florida","miami-florida","plantation-florida","atlanta-georgia","louisville-kentucky","baltimore-maryland","boston-massachusetts","grand-rapids-michigan","minneapolis-minnesota","rochester-minnesota","kansas-city-missouri","st-louis-missouri","reno-nevada","belleville-new-jersey","new-brunswick-new-jersey","albuquerque-new-mexico","rio-rancho-new-mexico","new-york-new-york","durham-north-carolina","grand-forks-north-dakota","cleveland-ohio","columbus-ohio","pittsburgh-pennsylvania","houston-texas","seattle-washington","blacktown-australia","concord-australia","south-brisbane-australia","brussels-belgium","edegem-belgium","leuven-belgium","namur-belgium","ottawa-canada","toronto-canada","montreal-canada","saguenay-canada","anhui-china","anyang-china","beijing-china","bengbu-china","changchun-china","changsha-china","chengdu-china","chongqicun-china","dalian-china","deyang-china","fuyang-china","fuzhou-china","guandong-china","guangdong-china","guangzhou-china","haikou-china","hangzhou-china","hebei-china","hubei-china","hunan-china","jieyang-china","jinan-china","kunming-china","lanzhou-china","linyi-china","luoyang-china","luzhou-china","nanchang-china","nanjing-china","nanning-china","nanyang-china","neijiang-china","ningbo-china","pingdingshan-china","qingdao-china","quanzhou-china","shanghai-china","shangai-china","shanxi-china","shaoyang-china","shenyang-china","shouguang-china","sichuan-china","tianjin-china","r-mqi-china","wenzhou-china","wuhan-china","wuhu-china","xi-ail-china","xiamen-china","xinzheng-china","xuzhou-china","yuncheng-china","zhejiang-china","zhengzhou-china","zhongshan-china","zhumadian-china","avignon-france","besan-on-france","bordeaux-france","caen-france","le-mans-france","lille-france","lyon-france","marseille-france","pierre-b-nite-france","poitiers-france","rouen-france","toulouse-france","villejuif-france","dresden-germany","m-nchen-germany","afula-israel","beersheba-israel","haifa-israel","jerusalem-israel","kfar-saba-israel","petah-tikva-israel","rehovot-israel","tel-aviv-israel","tel-hashomer-israel","ancona-italy","aviano-italy","candiolo-italy","meldola-italy","milan-italy","misterbianco-italy","modena-italy","naples-italy","novara-italy","padova-italy","parma-italy","pavia-italy","roma-italy","verona-italy","bia-a-podlaska-poland","gliwice-poland","krakow-poland","lodz-poland","poznan-poland","wieliszew-poland","bucharest-romania","cluj-napoca-romania","craiova-romania","pite-ti-romania","timi-oara-romania","singapore-singapore","gyeonggi-do-south-korea","jeollanam-do-south-korea","seoul-south-korea","barcelona-spain","c-rdoba-spain","madrid-spain","m-laga-spain","pamplona-spain","valencia-spain","changhua-taiwan","kaohsiung-city-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","ankaya-turkey-t-rkiye","apa-turkey-t-rkiye","kadik-y-turkey-t-rkiye","bornova-turkey-t-rkiye","konak-turkey-t-rkiye","i-zmit-turkey-t-rkiye","ankara-turkey-t-rkiye","bursa-turkey-t-rkiye","edirne-turkey-t-rkiye","izmir-turkey-t-rkiye","cardiff-united-kingdom","harlow-united-kingdom","leeds-united-kingdom","london-united-kingdom","manchester-united-kingdom","milton-keynes-united-kingdom","nottingham-united-kingdom","stockton-on-tees-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Lasofoxifene in combination with abemaciclib for Metastatic Breast Cancer","inPlainEnglish":"The goal of this clinical trial is to assess the how well it works, whether it is safe and how hard side effects are to live with of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation. The main question the study aims to answer is: • To compare the how well it works of the combination of lasofoxifene and abemaciclib with that of fulvestrant and abemaciclib Participants will receive either receive 5 mg/d of oral lasofoxifene plus oral abemaciclib 150 mg twice a day or the combination of fulvestrant 500 mg intramuscular (IM) on Days 1, 15, and 29 and then once monthly thereafter plus oral abemaciclib 150 mg twice a day.","whoItsFor":["Ages 18 Years to any","Pre- or postmenopausal women or men","Locally advanced and/or metastatic ER+ breast cancer with radiological or clinical evidence of progression on an AI in combination with either palbociclib or ribociclib as their first hormonal treatment for metastatic disease","Histological or cytological confirmation of ER+/HER2 - disease","No evidence of progression for at least 6 months on an AI/CDKi combination for advanced breast cancer","At least 1 or more ESR1 point mutations in the ESR1 ligand binding domain as assessed in cell- free ctDNA obtained from a blood or breast cancer tissue","Locally advanced or metastatic breast cancer with at least 1 measurable (according to RECIST 1.1) lesion with or without non-measurable lesions","Subjects may have received 1 cytotoxic chemotherapy regimen in the metastatic disease setting prior to study entry, but must have recovered from chemotherapy acute toxicity excluding alopecia and Grade 2 peripheral neuropathy"],"whoShouldSkip":["Lymphangitic carcinomatosis involving the lung","History of Grade 3 or Grade 4 interstitial lung disease (ILD) on previous therapy","Visceral crisis in need of cytotoxic chemotherapy as assessed by the investigator","Prior progression of disease on abemaciclib, fulvestrant, or other selective estrogen receptor degrader (SERD) therapy","Subjects with a known hypersensitivity to fulvestrant or to any of the excipients","Known RB1 mutations or deletions that in the opinion of the investigator confer resistance to CDK4/6i. (Screening for RB1 mutation is not required for entry.)","History of long QTc (Q-T interval corrected for heart rate) syndrome or a QTc of \\>480 msec"],"whatHappens":"If you join, the listed intervention(s) are Lasofoxifene in combination with abemaciclib, or Fulvestrant in combination with abemaciclib. The registry lists allocation as randomized. The goal of this clinical trial is to assess the how well it works, whether it is safe and how hard side effects are to live with of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treatment and have locally advanced or metastatic estrogen receptor positive (ER+)/human epidermal growth factor 2 negative (HER2-) breast cancer with an estrogen receptor 1 (ESR1) mutation.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 224 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.718Z"},{"nctId":"NCT05706831","title":"Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases","officialTitle":"Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are:\n\n* to evaluate the residual neuroplastic processes in DOC state related to music exposure\n* to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation\n* to evaluate the impact of this intervention on caregiver's burden and psychological distress.\n\nParticipants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.","conditions":["Disorder of Consciousness","Stroke"],"keywords":["music stimulation","tDCS","Aphasia","Neglect","DOC","Stroke"],"interventions":[{"type":"OTHER","name":"Combinatory effect of music stimulation and neurostimulation"}],"enrollment":90,"startDate":"2022-09-01","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> 18 years\n* Post-stroke aphasia\n* Post-stroke neglect\n* Patients with disorders of consciusness (DOC)\n\nExclusion Criteria:\n\n* No auditory injury\n* no hystory of neurological disease\n* No hystory of psychiatric disease\n* Previous stroke\n* use of alcohol and drugs\n* premorbid dementia","locations":[{"facility":"Istituti Clinici Scientifici Maugeri","city":"Bari","state":"Ba","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Simona Spaccavento","phone":"+393332783524","email":"simona.spaccavento@icsmaugeri.it"}],"primaryOutcomes":["Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neuropsychological outcomes","Neurophysiological outcome"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["bari-italy"],"enrichment":{"headline":"Not a traditional drug phase: Combinatory effect of music stimulation and neurostimulation for Disorder of Consciousness","inPlainEnglish":"The goal of this clinical trial is to measure the how well it works of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are: * to measure the residual neuroplastic processes in DOC state related to music exposure * to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation * to measure the impact of this intervention on caregiver's burden and psychological distress.","whoItsFor":["Ages 18 Years to any","Post-stroke aphasia","Post-stroke neglect","Patients with disorders of consciusness (DOC)"],"whoShouldSkip":["no hystory of neurological disease","No hystory of psychiatric disease","use of alcohol and drugs"],"whatHappens":"If you join, the listed intervention(s) are Combinatory effect of music stimulation and neurostimulation. The registry lists allocation as randomized. The goal of this clinical trial is to measure the how well it works of a musical interventionand non-invasive brain stimulation in neurological patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Bari. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.209Z"},{"nctId":"NCT05714085","title":"Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","officialTitle":"A Phase 2/3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.","conditions":["Heart Failure","Left Ventricular Systolic Dysfunction"],"keywords":[],"interventions":[{"type":"DRUG","name":"Vericiguat tablet"},{"type":"DRUG","name":"Vericiguat suspension"},{"type":"DRUG","name":"Placebo tablet"},{"type":"DRUG","name":"Placebo suspension"}],"enrollment":342,"startDate":"2023-05-31","completionDate":"2029-08-20","sex":"ALL","minAge":"29 Days","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\<45% assessed within 3 months before randomization.\n* Is of any sex/gender, from \\>28 days to \\<18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and/or IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and/or has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","locations":[{"facility":"The Regents of the University of California - Los Angeles (UCLA Pediatrics) ( Site 0002)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucile Packard Children's Hospital ( Site 0040)","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University Health System ( Site 0008)","city":"San Bernardino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado ( Site 0012)","city":"Aurora","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Children's National Medical Center ( Site 0020)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins All Children's Hospital ( Site 0029)","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta - Arthur M. 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The primary hypothesis is that vericiguat is superior to dummy treatment (placebo) in reducing NT-proBNP at Week 16 of the Base Period.","whoItsFor":["Ages 29 Days to 17 Years","Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction","Has biventricular physiology with a morphologic systemic left ventricle","Is currently receiving stable medical therapy for HF","Has left ventricular ejection fraction (LVEF) \\<45% assessed within 3 months before randomization","Is of any sex/gender, from \\>28 days to \\<18 years of age inclusive. 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The registry lists allocation as randomized. This study aims to compare the how well it works of vericiguat versus dummy treatment (placebo) on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 342 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.426Z"},{"nctId":"NCT05716100","title":"A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)","officialTitle":"A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Xenon Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.","conditions":["Focal Onset Seizures"],"keywords":["Epilepsy"],"interventions":[{"type":"DRUG","name":"XEN1101"},{"type":"DRUG","name":"Placebo"}],"enrollment":360,"startDate":"2023-05-09","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study\n* Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). 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Ocidental","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Hospitalar Universitário de Santo António","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Pedro Hispano","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Hospitalar de Entre o Douro e Vouga","city":"Santa Maria da Feira","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"ULS de Trás-os-Montes e Alto Douro","city":"Vila Real","state":"","country":"Portugal","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Hospital Universitario Cruces","city":"Barakaldo","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Unversitario Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital universitario Fundación Jiménez Díaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xenon Medical Affairs","phone":"1-604-484-3300","email":"XenonCares@xenon-pharma.com"}],"primaryOutcomes":["Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo."],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","downey-california","los-angeles-california","orange-california","gulf-breeze-florida","jacksonville-florida","boise-idaho","springfield-illinois","bethesda-maryland","detroit-michigan","hackensack-new-jersey","woodmere-new-york","durham-north-carolina","cleveland-ohio","columbus-ohio","portland-oregon","nashville-tennessee","austin-texas","salt-lake-city-utah","buenos-aires-argentina","c-a-b-a-argentina","c-rdoba-argentina","san-luis-argentina","san-miguel-de-tucum-n-argentina","camperdown-australia","randwick-australia","westmead-australia","melbourne-australia","innsbruck-austria","salzburg-austria","vienna-austria","brussels-belgium","ghent-belgium","sofia-bulgaria","santiago-chile","vi-a-del-mar-chile","osijek-croatia","rijeka-croatia","zagreb-croatia","hradec-kr-lov-czechia","prague-czechia","kuopio-finland","bron-france","lille-france","paris-france","rennes-france","strasbourg-france","aachen-germany","bielefeld-germany","frankfurt-germany","budapest-hungary","jerusalem-israel","ramat-gan-israel","rehovot-israel","tel-aviv-israel","ancona-italy","bari-italy","itami-japan","hamamatsu-japan","hiroshima-japan","kagoshima-japan","kyoto-japan","niigata-japan","tokushima-japan","tokyo-japan","benito-ju-rez-mexico","mexico-city-mexico","monterrey-mexico","sinaloa-mexico","heeze-netherlands","gdansk-poland","lublin-poland","nowa-s-l-poland","warsaw-poland","coimbra-portugal","guimar-es-portugal","lisbon-portugal","porto-portugal","santa-maria-da-feira-portugal","vila-real-portugal","barakaldo-spain","madrid-spain"],"enrichment":{"headline":"Phase 3: testing XEN1101 for Focal Onset Seizures","inPlainEnglish":"The X-TOLE3 Phase 3 clinical trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study that will measure the clinical how well it works, whether it is safe and how hard side effects are to live with of XEN1101 administered as added on top of your current treatment therapy in focal-onset seizures.","whoItsFor":["Ages 18 Years to any","Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP","Able to keep accurate seizure diaries"],"whoShouldSkip":["Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures","History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome","Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease","History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted","History of neurosurgery for seizures \\<1 year prior to Visit 1, or radiosurgery \\<2 years prior to enrollment","Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol"],"whatHappens":"If you join, the listed intervention(s) are XEN1101, or Placebo. The registry lists allocation as randomized. The X-TOLE3 Phase 3 clinical trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study that will measure the clinical how well it works, whether it is safe and how hard side effects are to live with of XEN1101 administered as added on top of your current treatment therapy in focal-onset seizures.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 360 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.909Z"},{"nctId":"NCT05717179","title":"Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach","officialTitle":"Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Italian Society for Rheumatology","sponsorClass":"OTHER","summary":"Population\n\nPatients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints)\n\nStudy design\n\nRandomised multicentre, parallel-arm clinical study\n\nPrimary objective\n\nNon-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.\n\nIntervention\n\nThis is a randomised multicentre, national, parallel-arm clinical study. Patients with a diagnosis of RA, moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or b-tsDMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) will be included and randomized to one of the following two strategic arms:\n\n1. Clinical decision strategy: All patients receive a new course of b-ts-DMARDs, with or without concomitant cDMARD. If a CDAI ≤10 is not achieved after 12 weeks, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use at week 12 is at the discretion of the investigator.\n2. Clinical plus ultrasound-based decision strategy. All patients in this group will be evaluated by ultrasound at 44 joints. In case of clinically-verified plus ultrasound verified inflammation, patients will receive a new b-ts-DMARD while continuing or not background csDMARD(s) therapy. If a CDAI ≤10 is not achieved after 12 weeks, patients are again evaluated by ultrasound at 44 joints. In case clinically-verified plus ultrasound-verified inflammation is present, patients are switched to a bDMARD or tsDMARD. The decision on which b/tsDMARD to use is at the discretion of the investigator. In case clinically-verified plus ultrasound-verified inflammation is absent, patients receive step-up pain therapy while background treatment will be continued.\n\nSample size\n\n158 patients\n\nTime plan\n\n* Total duration of the study: 72 months\n* Active phase for each patient: 48 weeks (24 weeks for the interventional treatment strategy and 24 weeks for follow-up visit)\n* Recruitment: 60 months","conditions":["Arthritis, Rheumatoid","Ultrasound","Treat to Target"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Ultrasound"}],"enrollment":158,"startDate":"2023-02-22","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":"84 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Classification of RA according to the ACR-EULAR 2010 criteria\n2. Age of the patients: 18 to 84 years\n3. Patients with moderate or high disease activity according to CDAI (\\>10)\n4. Maximum of 2 clinically swollen joints out of a 44-joint count\n5. Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months\n6. No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg/day prednisone equivalent.\n7. No corticosteroid intraarticular injection within 4 weeks\n8. Stable or absent dose of NSAIDs for at least 1 week\n9. Patients able and willing to give written informed consent and compliant with the requirements of the study protocol\n\nExclusion Criteria:\n\n1. Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician\n2. Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality\n3. Initial arthritis manifestations before the age of 18 years\n4. Planned surgery within the study period for any of the joints investigated either clinically or by sonography\n5. Current severe medical illness requiring hospitalization\n6. Active infection or active malignancy at screening \\<5 years\n7. Any contraindication to b/ts DMARDs according to the \"Summary of Product Characteristics\"\n8. Pregnancy or lactation","locations":[{"facility":"Azienda Sanitaria dell'Alto Adige","city":"Bruneck","state":"Bolzano","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christian Dejaco, MD, PhD","phone":"+390474581862","email":"Christian.Dejaco@sabes.it"}],"primaryOutcomes":["Non-inferiority of ultrasound-based decision strategy compared to clinically-based strategy."],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["bruneck-italy"],"enrichment":{"headline":"Not a traditional drug phase: Ultrasound for Arthritis, Rheumatoid","inPlainEnglish":"Population Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) Study design randomly assigned multicentre, parallel-arm clinical study Primary objective Non-inferiority of the experimental arm (i.e. clinical therapy together with ultrasound guided treatment decision) in comparison to the control arm (clinically guided decision) concerning the proportion of patients reaching low disease activity (CDAI ≤10) and a minimal clinical important improvement (MCII: improvement of ≥6 points if starting from moderate disease activity, any case starting from high disease activity and achieving low disease activity) or remission according to ACR/EULAR index-based remission criteria (CDAI ≤2.8/Boolean remission) at week 24.","whoItsFor":["Ages 18 Years to 84 Years","Classification of RA according to the ACR-EULAR 2010 criteria","Age of the patients: 18 to 84 years","Patients with moderate or high disease activity according to CDAI (\\>10)","Maximum of 2 clinically swollen joints out of a 44-joint count","Current stable treatment with a single csDMARD or bDMARD or tsDMARD for at least 3 months","No glucocorticoid therapy or stable glucocorticoid dose for at least 4 weeks and at a maximum dose of 5 mg/day prednisone equivalent","No corticosteroid intraarticular injection within 4 weeks"],"whoShouldSkip":["Complete (clinically evident) destruction of any joint to be investigated by ultrasound as judged by the physician","Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-manifestation except for rheumatoid nodules, which in the opinion of the investigator would expose the study subject to a high risk of morbidity or mortality","Initial arthritis manifestations before the age of 18 years","Planned surgery within the study period for any of the joints investigated either clinically or by sonography","Current severe medical illness requiring hospitalization","Active infection or active malignancy at screening \\<5 years","Any contraindication to b/ts DMARDs according to the \"Summary of Product Characteristics\""],"whatHappens":"If you join, the listed intervention(s) are Ultrasound. The registry lists allocation as randomized. Population Patients with a diagnosis of Rheumatoid Arthritis (RA), moderate or high clinical disease activity (CDAI\\>10) despite conventional synthetic (cs)DMARD(s) or bs-ts-DMARDs therapy for ≥3 months, and a maximum of 2 swollen joints (out of 44 joints) Study design randomly assigned multicentre, parallel-arm clinical study Primary objective Non-inferiority of the experimental arm (i.e.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 158 people at Bruneck. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.956Z"},{"nctId":"NCT05724121","title":"Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","officialTitle":"Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nBruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm. This can cause sudden death. In this natural history study, researchers want to learn how BTKi affects the heart.\n\nObjective:\n\nTo identify and monitor the effects of BTKi on the heart.\n\nEligibility:\n\nPeople aged 18 and older currently receiving or planning to receive BTKi or venetoclax.\n\nDesign:\n\nParticipants who have not yet started BTKi will have 2 required clinic visits: 1 before they start taking BTKi, and 1 about 6 months later. Participants who are already taking BTKi will have 1 required visit.\n\nParticipants will undergo multiple tests:\n\nA physical exam, including collection of blood and saliva.\n\nA test that measures heart activity via stickers placed on the chest.\n\nA test that uses sound waves to capture images of the heart.\n\nAn exercise stress test that monitors heart activity and blood pressure while the participant works on a treadmill or stationary bike. Sound wave images of the heart may also be taken while the participant exercises.\n\nStress magnetic resonance imaging (MRI) may be done in place of an exercise test. Participants will lie on a table that slides into a tube. They will be given drugs to stress the heart while images are taken.\n\nParticipants may wear a device to monitor their heart at home.\n\nParticipants may have repeat visits if they develop heart symptoms or if they need to stop taking BTKi. They will have follow-up phone calls each year for up to 3 years.","conditions":["Chronic Lymphocytic Leukemia (CLL)","Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia","Mantle Cell Lymphoma","Sudden Cardiac Death","Cardiac Arrhythmias","Hematologic Malignancies"],"keywords":["SUDDEN CARDIAC DEATH","Chronic Lymphocytic Leukemia (CLL)","Ibrutinib Treatment","Atrial Fibrillation/Flutter","Ventricular Arrhythmias","Natural History"],"interventions":[],"enrollment":135,"startDate":"2023-03-01","completionDate":"2027-04-08","sex":"ALL","minAge":"18 Years","maxAge":"110 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Currently receiving or planning to receive a BTKi or venetoclax.\n2. Male or female, aged 18 or older\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Ability of subject to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months\n2. Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ingrid C Frey","phone":"(301) 402-0797","email":"ingrid.frey@nih.gov"},{"name":"Christine E Gruessner, M.D.","phone":"(240) 550-6022","email":"christine.gruessner@nih.gov"}],"primaryOutcomes":["arrhythmogenic cardiac effects of BTKi and sudden death within the first 12 months of BTKi therapy"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax","inPlainEnglish":"Background: Bruton s tyrosine kinase inhibitors (BTKi) are used to treat a form of leukemia. But taking BTKi can also increase a person s risk of developing an abnormal heart rhythm.","whoItsFor":["Ages 18 Years to 110 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Currently receiving or planning to receive a BTKi or venetoclax","Male or female, aged 18 or older","Stated willingness to comply with all study procedures and availability for the duration of the study"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Any acute cardiac condition including myocardial infarction or decompensated heart failure within the past 3 months","Pregnancy or lactation- use of BTK inhibitors is contraindicated in pregnant or nursing individuals"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 135 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.747Z"},{"nctId":"NCT05726032","title":"Empagliflozin in Patients With Cirrhosis and Ascites","officialTitle":"Effects of Empagliflozin on Natriuresis and Volume Overload in Patients With Cirrhosis and Ascites","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"A proof-of-concept placebo-controlled trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.","conditions":["Cirrhosis","Liver Failure"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"},{"type":"DRUG","name":"Matching Placebo"}],"enrollment":20,"startDate":"2023-09-11","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses\n2. eGFR \\>= 30mL/min/1.73 m2\n3. \\>=18 years old\n\nExclusion Criteria:\n\n1. Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)\n2. Direct bilirubin \\>=3 mg/dL\n3. Systolic blood pressure \\< 100 mmHg\n4. Active malignancy including hepatocellular carcinoma undergoing treatment\n5. History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections\n6. Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance\n7. Type 1 diabetes\n8. History of frequent hypoglycemic episodes\n9. Use of a non-loop diuretic aside from aldosterone antagonists or amiloride as they are not standard of care in patients with cirrhosis and could potentially increase the risk of hypovolemia when combined with the standard treatment for ascites along with SGLT2 inhibitor.\n10. Hepatic hydrothorax requiring thoracentesis in the prior 8 weeks\n11. Hepatic encephalopathy grade II or greater at the time of enrollment\n12. Patients who have had TIPS placed\n13. Previous liver transplant\n14. Participation in another trial with an investigational drug within the 30 days prior to informed consent\n15. Pregnancy or breastfeeding\n16. Inability to give written informed consent or follow study protocol (e.g. clinically-significant psychiatric, addictive, or neurological disease)\n17. Change in diuretic dose in the prior 2 weeks\n18. Patients with hospitalization for alcoholic hepatitis in the past 6 months\n19. Significant worsening of creatinine (more than 50% increase) in the past 4 weeks\n20. MELD-Na \\> or equal to 20\n21. Hemoglobin \\<8","locations":[{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Veena Rao, PHD","phone":"2037373571","email":"veena.s.rao@yale.edu"},{"name":"Kara Otis","phone":"2037373571","email":"kara.otis@yale.edu"}],"primaryOutcomes":["Change in FENa with administration of study drug (10 mg empagliflozin vs. identical placebo)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["empagliflozin"],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Phase 2: testing Empagliflozin 10 MG for Cirrhosis","inPlainEnglish":"A proof-of-concept compared with a dummy treatment trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites. We will additionally investigate its effect on neurohumoral activation, and renal hemodynamics.","whoItsFor":["Ages 18 Years to any","Patients with cirrhosis and ascites on a stable dose of diuretics (spironolactone +/- loop-diuretics based on AASLD guidelines)10 and who do not require large volume paracenteses","eGFR \\>= 30mL/min/1.73 m2"],"whoShouldSkip":["Hospitalization due to a complication of cirrhosis in the previous 8 weeks (e.g. variceal hemorrhage, encephalopathy, acute kidney injury, spontaneous bacterial peritonitis)","Direct bilirubin \\>=3 mg/dL","Systolic blood pressure \\< 100 mmHg","Active malignancy including hepatocellular carcinoma undergoing treatment","History of bladder dysfunction, incontinence, pyelonephritis, urosepsis, or frequent urinary tract infections","Use of SGLT-2 inhibitors in the last 10 days, or previous use with intolerance","History of frequent hypoglycemic episodes"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG, or Matching Placebo. The registry lists allocation as randomized. A proof-of-concept compared with a dummy treatment trial to explore the acute and 14-day effects of empagliflozin on natriuresis and total body water in patients with cirrhosis and ascites.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.617Z"},{"nctId":"NCT05730036","title":"A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma","officialTitle":"An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called linvoseltamab, also called REGN5458.\n\nLinvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).\n\nThis study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.\n\nThis study is looking at several other research questions, including:\n\n* How long participants benefit from receiving linvoseltamab compared with EPd\n* How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much\n* What side effects happen from taking linvoseltamab compared to EPd\n* How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd\n* If there is any improvement in pain after treatment with linvoseltamab compared to EPd","conditions":["Relapsed Refractory Multiple Myeloma (RRMM)"],"keywords":["BCMA X CD3 Bispecific Monoclonal Antibody","CD38 antibody","Proteasome inhibitor","Lenalidomide"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"},{"type":"DRUG","name":"Elotuzumab"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Dexamethasone"}],"enrollment":410,"startDate":"2023-09-18","completionDate":"2033-04-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.\n3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.\n\n   Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.\n4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol\n5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium\n6. Life expectancy of at least 6 months\n\nKey Exclusion Criteria:\n\n1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).\n2. Prior treatment with elotuzumab and/or pomalidomide\n3. Participants with known MM brain lesions or meningeal involvement\n4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter\n5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.\n6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.\n7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).\n8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug\n9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \\<40%.\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"University of California Los Angeles (UCLA)","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Florida Division of Sponsored Programs","city":"Gainesville","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Kentucky, Markey Cancer Center Clinical Research Organization","city":"Lexington","state":"Kentucky","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute","city":"Louisville","state":"Kentucky","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Stony Brook University","city":"Stony Brook","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Center","city":"Charlotte","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Kaiser Permanente Northwest","city":"Portland","state":"Oregon","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Royal Prince Alfred Hospital","city":"Camperdown","state":"New South Wales","country":"Australia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Royal North Shore Hospital","city":"St Leonards","state":"New South Wales","country":"Australia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Icon Cancer Centre - 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City","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Chang Gung Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Wanfang Hospital","city":"Taipei","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Tri-Service General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"Cambrigeshire","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Western General Hospital","city":"Edinburgh","state":"Scotland","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham","city":"Birmingham","state":"West Midlands","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Guy's & St Thomas' NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants"],"hasResults":false,"conditionSlugs":["multiple-myeloma","als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","gainesville-florida","lexington-kentucky","louisville-kentucky","stony-brook-new-york","charlotte-north-carolina","durham-north-carolina","portland-oregon","houston-texas","seattle-washington","camperdown-australia","st-leonards-australia","auchenflower-australia","herston-australia","adelaide-australia","hobart-australia","launceston-australia","fitzroy-australia","geelong-australia","heidelberg-australia","nedlands-australia","yvoir-belgium","roeselare-belgium","antwerp-belgium","brussels-belgium","salvador-brazil","curitiba-brazil","bento-gon-alves-brazil","porto-alegre-brazil","lages-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","ottawa-canada","toronto-canada","santiago-chile","vi-a-del-mar-chile","lyon-france","pessac-france","lille-france","paris-france","saint-cloud-france","villejuif-france","t-bingen-germany","l-beck-germany","hamburg-germany","leipzig-germany","haifa-israel","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","san-giovanni-rotondo-italy","meldola-italy","genoa-italy","alessandria-italy","turin-italy","candiolo-italy","ancona-italy","bologna-italy","catania-italy","pavia-italy","ravenna-italy","reggio-emilia-italy","varese-italy","nagakute-japan","chiba-japan","kamogawa-japan","kashiwa-shi-japan","kurume-japan","gaki-japan","maebashi-japan","shibukawa-japan","sapporo-japan","shiwa-gun-japan","kumamoto-japan","kita-ku-japan","suita-shi-japan","iruma-gun-japan","tokushima-japan","shibuya-ku-japan","kofu-japan","fukushima-japan","sendai-japan","nijmegen-netherlands","dordrecht-netherlands","gdansk-poland","bydgoszcz-poland","katowice-poland","lublin-poland","lodz-poland","singapore-singapore","incheon-south-korea","jeonju-south-korea","hwasun-south-korea","busan-south-korea","seoul-south-korea","santiago-de-compostela-spain","vitoria-gasteiz-spain","palma-spain","palma-mallorca-spain","badalona-spain","terrassa-spain","santander-spain","le-n-spain","majadahonda-spain","pozuelo-de-alarc-n-spain","pamplona-spain","gij-n-spain","oviedo-spain","madrid-spain","alicante-spain","barcelona-spain","girona-spain","m-laga-spain","seville-spain","valencia-spain","zaragoza-spain","taoyuan-taiwan","changhua-taiwan","hualien-city-taiwan","kaohsiung-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","cambridge-united-kingdom","edinburgh-united-kingdom","birmingham-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Linvoseltamab for Relapsed Refractory Multiple Myeloma (RRMM)","inPlainEnglish":"This study is researching an experimental drug called linvoseltamab, also called REGN5458. Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed.","whoItsFor":["Ages 18 Years to any","Age 18 years or older (or legal adult age in the country) at the time of the screening visit","Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor","Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody","Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol","Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium","Life expectancy of at least 6 months"],"whoShouldSkip":["Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)","Prior treatment with elotuzumab and/or pomalidomide","Participants with known MM brain lesions or meningeal involvement","Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter","Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed","History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism)","Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug"],"whatHappens":"If you join, the listed intervention(s) are Linvoseltamab, Elotuzumab, or Pomalidomide. The registry lists allocation as randomized. This study is researching an experimental drug called linvoseltamab, also called REGN5458.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 410 people at 159 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.493Z"},{"nctId":"NCT05732155","title":"Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD","officialTitle":"Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Guy Schusheim","sponsorClass":"OTHER","summary":"The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol.\n\nThe overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .","conditions":["Post Traumatic Stress Disorder","MDMA ('Ecstasy')"],"keywords":["post traumatic stress disorder","PTSD","MDMA","Psychedelics","Group"],"interventions":[{"type":"DRUG","name":"methylenedioxymethamphetamine"}],"enrollment":60,"startDate":"2023-06-01","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Experienced war-related trauma.\n* Fluent in speaking and reading Hebrew.\n* Able to swallow capsules.\n* Willing to have study visits, including MDMA experimental sessions and non-drug psychotherapy sessions, audio- and/or video-recorded as specified by the protocol.\n* Able to identify a relative, spouse, close friend, or other support person who can be contacted by the investigators if the participant becomes suicidal or cannot be reached.\n* Agrees to inform the investigators within 48 hours of relevant medical conditions or procedures.\n* Agrees to comply with study requirements, including fasting and medication restrictions before experimental sessions, refraining from participation in other interventional clinical trials during the study, remaining overnight at the study site after each experimental session, arranging accompanied transportation after discharge, and complying with study medication, psychotherapy, and assessment procedures.\n* At screening, meets DSM-5 criteria for current PTSD of the protocol-specified minimum duration.\n* At screening, has at least moderate PTSD symptom severity, defined as a CAPS-5 total score of 28 or greater.\n\nExclusion Criteria\n\n* Unable to provide adequate informed consent.\n* Use of Ecstasy or material represented as containing MDMA more than 10 times during the previous 10 years, or any such use within 6 months before the first experimental session.\n* Previous participation in a MAPS-sponsored MDMA clinical trial.\n* Any current medical, psychiatric, psychosocial, or other condition that, in the judgment of the investigator or study physician, could interfere with safe or effective participation.\n* Known sensitivity or allergy to MDMA or another study intervention that, in the judgment of the sponsor-investigator or study clinician, contraindicates participation.\n* Electroconvulsive therapy within 12 weeks before enrollment.\n* Current or lifetime primary psychotic disorder.\n* Current eating disorder involving active purging, as assessed by the MINI and clinical interview.\n* Current major depressive disorder with psychotic features, as assessed by the MINI.\n* Current alcohol or substance use disorder judged by the investigators, therapy team, or study physician to represent a safety concern.\n* Active illicit-drug or prescription-drug substance use disorder, other than caffeine or nicotine use disorder, within 12 months before enrollment, as defined by the protocol.\n* Current personality disorder meeting the protocol-specified exclusion criteria.\n* Current serious suicide risk.\n* Requirement for ongoing treatment with a psychiatric medication that cannot be discontinued or is not permitted under the protocol, except as specified in the concomitant-medication provisions.\n* Medical condition for which exposure to a sympathomimetic drug or associated increases in blood pressure or heart rate would pose an unacceptable risk.\n* Uncontrolled hypertension, defined according to the protocol as blood pressure of 140/90 mmHg or higher on three separate occasions.\n* History of ventricular arrhythmia other than premature ventricular contractions in the absence of ischemic heart disease.\n* Wolff-Parkinson-White syndrome or another accessory conduction pathway that has not been successfully treated by ablation.\n* History of clinically significant arrhythmia within 12 months before screening, other than premature atrial contractions or occasional premature ventricular contractions in the absence of ischemic heart disease.\n* Baseline QTc prolongation greater than 450 ms in males or greater than 460 ms in females, corrected using Fridericia's formula.\n* Additional risk factors for torsade de pointes, including heart failure, hypokalemia, or a family history of long-QT syndrome.\n* Requirement for concomitant medications that prolong the QT/QTc interval during experimental sessions.\n* Symptomatic liver disease or clinically significant liver-enzyme elevations.\n* History of hyponatremia or hyperthermia.\n* Body weight below 48 kg.\n* Ketamine-assisted therapy or ketamine use within 12 weeks before enrollment.","locations":[{"facility":"Emek medical center","city":"Afula","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Guy Schusheim, Dr","phone":"972-4-6494138","email":"guy_sc@clalit.org.il"},{"name":"Gilat ron avraham, Mph","phone":"972-4-6495590","email":"gilat_av@clalit.org.il"}],"primaryOutcomes":["Change from pre-treatment baseline to post-treatment in CAPS-5 total score"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["afula-israel"],"enrichment":{"headline":"Phase 2: testing methylenedioxymethamphetamine for Post Traumatic Stress Disorder","inPlainEnglish":"The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol. The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious side effects (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .","whoItsFor":["Ages 18 Years to any","Experienced war-related trauma","Fluent in speaking and reading Hebrew","Able to swallow capsules","Willing to have study visits, including MDMA experimental sessions and non-drug psychotherapy sessions, audio- and/or video-recorded as specified by the protocol","Able to identify a relative, spouse, close friend, or other support person who can be contacted by the investigators if the participant becomes suicidal or cannot be reached","Agrees to inform the investigators within 48 hours of relevant medical conditions or procedures","At screening, meets DSM-5 criteria for current PTSD of the protocol-specified minimum duration"],"whoShouldSkip":["Use of Ecstasy or material represented as containing MDMA more than 10 times during the previous 10 years, or any such use within 6 months before the first experimental session","Previous participation in a MAPS-sponsored MDMA clinical trial","Any current medical, psychiatric, psychosocial, or other condition that, in the judgment of the investigator or study physician, could interfere with safe or effective participation","Known sensitivity or allergy to MDMA or another study intervention that, in the judgment of the sponsor-investigator or study clinician, contraindicates participation","Electroconvulsive therapy within 12 weeks before enrollment","Current or lifetime primary psychotic disorder","Current eating disorder involving active purging, as assessed by the MINI and clinical interview"],"whatHappens":"If you join, the listed intervention(s) are methylenedioxymethamphetamine. The registry lists allocation as randomized. The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Afula. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.417Z"},{"nctId":"NCT05752396","title":"Overlapping Pain Trajectory Study","officialTitle":"Disrupted Spatial and Temporal Nociceptive Filtering in Adolescents With and Risk for Overlapping Pain Conditions","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Children's Hospital Medical Center, Cincinnati","sponsorClass":"OTHER","summary":"The goal of this observational study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are:\n\n1. If spatial and temporal filtering of nociceptive information is disrupted in youth with COPCs compared with youth with localized pain conditions and healthy controls.\n2. If disrupted nociceptive processing at baseline is associated with the transition from a single localized pain condition to COPCs in youth.\n\nParticipation includes:\n\n* quantitative sensory testing\n* blood draw\n* sleep assessment\n* questionnaires","conditions":["Migraine","Musculoskeletal Pain","Functional Abdominal Pain Disorders","Chronic Pain","Widespread Chronic Pain","Low Back Pain","Healthy Volunteers"],"keywords":[],"interventions":[{"type":"OTHER","name":"Conditioned Pain Modulation"},{"type":"OTHER","name":"Offset Analgesia"},{"type":"OTHER","name":"Spatial Summation"},{"type":"OTHER","name":"Temporal Summation"}],"enrollment":420,"startDate":"2023-03-01","completionDate":"2028-07-01","sex":"ALL","minAge":"10 Years","maxAge":"19 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. General Criteria\n\n   * Access to the internet either by laptop, tablet, or phone (for REDCap Surveys)\n   * English-speaking\n   * Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent\n2. Control Specific Criteria\n\n   * No history/active chronic pain\n3. Patient Specific Criteria\n\n   * Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain)\n   * If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.\n\nExclusion Criteria:\n\n1. General Criteria\n\n   * Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing\n   * Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)\n2. Control Specific Criteria\n\n   * Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)\n3. Patient Specific Criteria\n\n   * Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study","locations":[{"facility":"Cincinnati Children's Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kacie Peters","phone":"513-517-0594","email":"Kacie.Peters@cchmc.org"},{"name":"Catherine Jackson","phone":"513-636-0669","email":"Catherine.Jackson@cchmc.org"}],"primaryOutcomes":["Conditioned Pain Modulation (CPM) Profile (Pressure)","Conditioned Pain Modulation (CPM) Profile (Heat)","Offset Analgesia (OA) Profile","Temporal Summation (TS) Profile","Spatial Summation (SS) Profile"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["cincinnati-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Conditioned Pain Modulation for Migraine","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to learn about spatial and temporal nociceptive filtering in adolescents with chronic overlapping pain conditions (COPCs). The main questions it aims to answer are: 1.","whoItsFor":["Ages 10 Years to 19 Years","Access to the internet either by laptop, tablet, or phone (for REDCap Surveys)","Control Specific Criteria","No history/active chronic pain","Patient Specific Criteria","Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain)","If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit"],"whoShouldSkip":["Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing","Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)","Control Specific Criteria","Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)","Patient Specific Criteria"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 420 people at Cincinnati. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.302Z"},{"nctId":"NCT05753930","title":"Imlifidase Prior to Kidney Transplant in Highly Sensitised Children","officialTitle":"A Single-arm, Multi-centre Trial to Evaluate Efficacy and Safety of Imlifidase in Highly Sensitised Children (1-17 Years) Receiving a Kidney Transplant With Positive Crossmatch Against a Living or Deceased Donor Converted to Negative After Imlifidase Treatment","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hansa Biopharma AB","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn about the efficacy and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).\n\nThe main questions it aims to answer are:\n\n* Does imlifidase treatment result in crossmatch conversion that enables transplantation?\n* How is the function of the transplanted kidney?\n\nThe participants will be hospitalised in accordance with the normal routines for transplanted patients. The patients will receive medication to prevent rejection of the donor kidney, and because such treatment make the body more vulnerable medications to prevent infections.","conditions":["Kidney Transplantation in Highly Sensitized Patients"],"keywords":["Desensitization","Highly sensitized","Positive crossmatch","Unlikely to be transplanted","Kidney transplantation","Deceased donor","Living donor","End-Stage Renal Disease","Paediatric patients","Children","Incompatible transplant"],"interventions":[{"type":"DRUG","name":"Imlifidase"}],"enrollment":10,"startDate":"2023-06-02","completionDate":"2027-02-28","sex":"ALL","minAge":"1 Year","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed Informed Consent obtained from patient/parent/legal guardian/independent witness (depending on patient's age) before any trial-related procedures\n2. Highly sensitised patient with panel reactive antibodies (PRA) ≥80%\n3. Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening\n4. Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor\n5. Patient must be transplantable (including size mismatch) at the time of obtaining informed consent for trial participation\n6. Patients who have previously undergone desensitisation unsuccessfully with plasmapheresis/IVIg/anti-CD20 or have an anti-HLA antibody status deemed too difficult to make a successful desensitisation (judgement based on physicians' previous experience with similar patients)\n7. Positive crossmatch (XM) test determined by flow cytometry crossmatch (FCXM) and/or complement-dependent cytotoxicity crossmatch (CDCXM) tests against the donor. For the DD patients, if physical XM tests are not practically possible due to lack of time, patients may be included on a virtual crossmatch (vXM) predictive of a positive XM test.\n8. Willingness and ability to comply with the protocol as judged by the investigator\n\nExclusion Criteria:\n\n1. Previous treatment with imlifidase\n2. IVIg treatment within 28 days prior to imlifidase treatment\n3. Desensitisation treatment(s) within 1 month prior to the current transplantation\n4. Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol\n5. Ongoing serious infections\n6. Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP\n7. At the time of transplantation: severe other condition requiring treatment and close monitoring e.g. cardiac failure ≥ grade 4 (New York Heart Association), unstable coronary disease, active peripheral vascular disease, proven hypercoagulable conditions/events or oxygen dependent respiratory disease\n8. Malignancy within 3 years prior to transplantation\n9. ABO blood group incompatible transplantations (A2 and A2B kidneys will not be accepted for B recipients)\n10. Any other reason that, in the view of the investigator, precludes transplantation\n11. Breast feeding or pregnancy, if applicable\n12. Woman of fertile age and sexually active without adequate contraceptive measures to avoid pregnancy during the interventional trial period (i.e. up to 6 months after transplantation)\n13. Suspicion of Covid-19 infection or positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test\n14. Positive serology for human immunodeficiency virus (HIV)\n15. Clinical signs of hepatitis B virus (HBV), hepatitis C virus (HCV), cytomegalovirus (CMV), or Epstein Barr virus (EBV) infection\n16. Donor with positive serology for HIV, HBV, HCV or CMV to a patient with negative serology (mismatch serology). Mismatch serology for EBV in accordance with center specific standard procedures for transplantation of EBV negative recipients and at investigator's discretion.\n17. Clinically relevant active infection(s) as judged by the investigator\n18. Tuberculosis or history of tuberculosis\n19. Use of other investigational agents within 5 terminal elimination half-lives prior to the transplantation\n20. Contemporaneous participation in medical device studies\n21. Known mental incapacity or language barriers precluding patients'/parents'/legal guardians' adequate understanding of the informed consent information and the trial activities\n22. Inability by the judgement of the investigator to participate in the trial for any other reason","locations":[{"facility":"HUS, Helsinki University Hospital","city":"Helsinki","state":"","country":"Finland","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Robert Debre University Hospital","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Unviersitari Vall d'Hebron, Nefrología Pediátrica","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan De Deu Barcelona","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Karolinska University Hospital","city":"Huddinge","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital for Children NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Central Contact","phone":"+46 46 16 56 70","email":"clinicalstudyinfo@hansabiopharma.com"}],"primaryOutcomes":["Proportion of patients with conversion of a positive crossmatch test to negative within 24 hours after start of imlifidase treatment"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["helsinki-finland","paris-france","rome-italy","barcelona-spain","huddinge-sweden","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Imlifidase for Kidney Transplantation in Highly Sensitized Patients","inPlainEnglish":"The goal of this clinical trial is to learn about the how well it works and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD). The main questions it aims to answer are: * Does imlifidase treatment result in crossmatch conversion that enables transplantation?","whoItsFor":["Ages 1 Year to 17 Years","Highly sensitised patient with panel reactive antibodies (PRA) ≥80%","Male or female patient between the age of 1 to 17 years (up to the day before the 18th birthday) at the time of screening","Patient with end-stage renal disease (ESRD) and waiting for a renal transplant from a living or deceased donor","Patients who have previously undergone desensitisation unsuccessfully with plasmapheresis/IVIg/anti-CD20 or have an anti-HLA antibody status deemed too difficult to make a successful desensitisation (judgement based on physicians' previous experience with similar patients)","Willingness and ability to comply with the protocol as judged by the investigator"],"whoShouldSkip":["Previous treatment with imlifidase","IVIg treatment within 28 days prior to imlifidase treatment","Desensitisation treatment(s) within 1 month prior to the current transplantation","Hypersensitivity to the active substance (imlifidase) or to any of the excipients and to other immunosuppressive drugs specified in the protocol","Ongoing serious infections","Present, or history of, thrombotic thrombocytopenic purpura (TTP), or known familial history of TTP","Malignancy within 3 years prior to transplantation"],"whatHappens":"If you join, the listed intervention(s) are Imlifidase. The registry lists allocation as na. The goal of this clinical trial is to learn about the how well it works and safety of imlifidase in highly sensitized paediatric patients, 1-17 years old, with end stage renal disease (ESRD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 10 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.486Z"},{"nctId":"NCT05758831","title":"RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis.","officialTitle":"A Prospective Randomized Trial of Non-inferiority Comparing RItuximab Versus Ocrelizumab in Relapsing-remitting Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Rennes University Hospital","sponsorClass":"OTHER","summary":"The goal of this randomized clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.\n\nDuring the 2 years, the study includes 6 follow-up visits and the completion of various health and quality of life questionnaires. The protocol visits follow the usual schedule of treatment infusions for the disease (at initiation of treatment, 15 days after, and then every 6 months).\n\nTwo comparison groups: Researchers will compare rituximab treated patients versus ocrelizumab treated patients to see the % of patients without disease activity at 2 years.","conditions":["Multiple Sclerosis","Relapsing-remitting Multiple Sclerosis"],"keywords":["Multiple Sclerosis","Relapsing-remitting"],"interventions":[{"type":"DRUG","name":"Perfusion of treatment Rituximab"},{"type":"DRUG","name":"Perfusion of treatment Ocrelizumab"}],"enrollment":386,"startDate":"2023-06-01","completionDate":"2030-03-31","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);\n* Age between 18 and 55 years\n* EDSS ≤ 5\n* Brain MRI within 6 months before inclusion\n* For women of childbearing potential\\*: effective contraception (effective contraception include oral contraception, intrauterine devices and other forms of contraception with failure rate \\<1%, for the duration of the study and until 12 months after last dose administered) \\* A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\nA postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n\n* Having signed an informed consent form\n* Patients covered with social insurance\n\nNon-Inclusion Criteria:\n\n* Secondary or primary progressive MS;\n* Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;\n* Previous treatment by fingolimod or natalizumab in the last 4 weeks;\n* Treatment with high dose corticosteroids during the 30 days preceding the inclusion;\n* Occurrence of a relapse less than 30 days before inclusion;\n* Pregnancy or breastfeeding;\n* Other neurologic or systemic disease;\n* Concomitant participation or Participation in another therapeutic trial in the last 6 months;\n* Incapacity to understand or sign the consent form;\n* Contraindication to MRI;\n* Contraindication to anti-CD20 therapies:\n\n  * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization\n  * Active malignancy.\n  * Any ongoing infection\n  * Severe heart failure (New York Heart Association Class IV) or severe uncontrolled cardiac disease\n  * Positive test for HIV, hepatitis B or C, or tuberculosis\n  * Severe immune deficiency:\n* Lymphopenia grade 3 (0.2 to 0.5 × 10\\^9/L) or higher grades\n* Neutropenia grade 3 (0.5 to 1.0 × 10\\^9/L) or higher grades\n\n  * Known hypersensitivity or other known side effects for any of the study medications, including co-medications such as high glucocorticosteroids\n  * AST or ALT \\>=3ULN\n  * Platelet (thrombocyte) count \\< 100 x 10\\^9/L\n* Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty.","locations":[{"facility":"Hospices Civils de Lyon Hôpital Neurologique Pierre Wertheimer","city":"Lyon","state":"Bron","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Brest - Hôpital la Cavale Blanche","city":"Brest","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Caen","city":"Caen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Pontoise - GHT NOVO","city":"Cergy-Pontoise","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Gabriel Montpieds","city":"Clermont-Ferrand","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier de Gonnesse","city":"Gonesse","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Groupe Hospitalier de l'Institut Catholique de Lille","city":"Lille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Limoges","city":"Limoges","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AP-HM - Hôpital la Timone","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Montpellier - Hôpital Gui de Chauliac","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Régional de Nancy","city":"Nancy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nantes -Hôpital Nord Laennec","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nice - Hôpital Pasteur 2","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nîmes - Hôpital Caremeau","city":"Nîmes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AP-HP Höpital la Pitié-Salpétrière","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Groupe Hospitalier Universitaire Henri Mondor","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Saint-Germain","city":"Poissy","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Cornouaille","city":"Quimper","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Rouen - Hôpital Charles Nicolle","city":"Rouen","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Strasbourg - Hôpital Hautpierre","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Foch","city":"Suresnes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse - Bâtiment Pierre Paul Riquet","city":"Toulouse","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laure MICHEL, MD","phone":"0299286774","email":"laure.michel@chu-rennes.fr"},{"name":"Agnès Gazzola","phone":"0299289194","email":"agnes.gazzola@chu-rennes.fr"}],"primaryOutcomes":["To demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the percentage of patients without disease activity at 2 years."],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["lyon-france","brest-france","caen-france","cergy-pontoise-france","clermont-ferrand-france","gonesse-france","lille-france","limoges-france","marseille-france","montpellier-france","nancy-france","nantes-france","nice-france","n-mes-france","paris-france","poissy-france","quimper-france","rennes-france","rouen-france","strasbourg-france","suresnes-france","toulouse-france"],"enrichment":{"headline":"Phase 3: testing Perfusion of treatment Rituximab for Multiple Sclerosis","inPlainEnglish":"The goal of this randomly assigned clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years. The main question it aims to answer is : • to demonstrate the non-inferiority of rituximab versus ocrelizumab in active relapsing MS patients on the % of patients without disease activity at 2 years.","whoItsFor":["Ages 18 Years to 55 Years","Patients presenting a relapsing remitting MS according to Mac Donald 2017 criteria, with clinical or radiological criteria of activity (ie at least one relapse AND/OR one new T2 lesion in the last 12 months before inclusion);","Age between 18 and 55 years","Brain MRI within 6 months before inclusion","Patients covered with social insurance","Non-who can join:","Secondary or primary progressive MS;","Previous treatment by mitoxantrone, cladribine, alemtuzumab and anti CD20 therapies in the last two years;"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Perfusion of treatment Rituximab, or Perfusion of treatment Ocrelizumab. The registry lists allocation as randomized. The goal of this randomly assigned clinical trial is to compare relapse remitting multiple sclerosis (RRMS) patients treated by ocrelizumab or by rituximab followed for 2 years.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 386 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.995Z"},{"nctId":"NCT05759637","title":"Type 2 Diabetes, Obesity and Cortisol Excess","officialTitle":"Type 2 Diabetes, Obesity and Cortisol Excess","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istituto Auxologico Italiano","sponsorClass":"OTHER","summary":"The present observational cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.","conditions":["Diabetes Mellitus, Type 2","Obesity","Cortisol; Hypersecretion"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"1mg DST"}],"enrollment":3200,"startDate":"2022-05-06","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\npatients with T2D and Obesity\n\nExclusion Criteria:\n\n* pregnancy/breast feeding,\n* sleep apnea,\n* prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,\n* symptoms of hypercortisolism;\n* already known secondary hypertension;\n* conditions associated with increased hypothalamic-pituitary-adrenal (HPA) axis activity, -severe autoimmune/rheumatologic and hematologic diseases, alcoholism, kidney disease (glomerular filtration rate \\<60)\n* drugs influencing the HPA axis activity. For inclusion in Group 2 the presence of T2D will be an exclusion criteria","locations":[{"facility":"Istituto Auxologico Italiano","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niguarda Hospital","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Campus Bio-Medico University","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Siena","city":"Siena","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine","city":"Udine","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Valentina Morelli, PhD","phone":"02619112547","email":"v.morelli@auxologico.it"}],"primaryOutcomes":["Hidden Hypercortisolism prevalence in a sample of T2D patients","Hidden Hypercortisolism prevalence in a sample of Obese patients"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["milan-italy","roma-italy","siena-italy","udine-italy"],"enrichment":{"headline":"Not a traditional drug phase: 1mg DST for Diabetes Mellitus, Type 2","inPlainEnglish":"The present watch-and-measure (no experimental treatment required) cross-sectional study is aimed to assess: the hidden hypercortisolism (HidHyCo) prevalence in a sample of Type 2 diabetes (T2D) patients and the clinical characteristics more frequently associated with the HidHyCo presence and the HidHyCo prevalence in an adequate sample of obese patients without T2D and the clinical characteristics more frequently associated with the HidHyCo presence.","whoItsFor":["Ages 18 Years to 75 Years","patients with T2D and Obesity"],"whoShouldSkip":["pregnancy/breast feeding,","prepuberal onset of hypertension, hormonal hypersecreting adrenal mass,","symptoms of hypercortisolism;","already known secondary hypertension;","conditions associated with increased hypothalamic-pituitary-adrenal (HPA) axis activity, -severe autoimmune/rheumatologic and hematologic diseases, alcoholism, kidney disease (glomerular filtration rate \\<60)","drugs influencing the HPA axis activity. For inclusion in Group 2 the presence of T2D will be an"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,200 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.514Z"},{"nctId":"NCT05764538","title":"DAOIB for the Treatment of Brain Fog","officialTitle":"DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chang Gung Memorial Hospital","sponsorClass":"OTHER","summary":"This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.","conditions":["Long COVID"],"keywords":[],"interventions":[{"type":"DRUG","name":"DAOIB"}],"enrollment":40,"startDate":"2023-02-27","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \"post-COVID-19 condition\" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments\n* physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits\n* have sufficient education to communicate effectively and are capable of completing the assessments of the study\n\nExclusion Criteria:\n\n* history of significant cerebrovascular disease\n* Hachinski Ischemic Score \\> 4\n* major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments\n* memantine use (memantine is an NMDAR partial antagonist)\n* substance (including alcohol) abuse or dependence\n* delusion, hallucination or delirium symptoms\n* severe visual or hearing loss\n* inability to follow the protocol","locations":[{"facility":"Kaohsiung Chang Gung Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["kaohsiung-city-taiwan"],"enrichment":{"headline":"Phase 2: testing DAOIB for Long COVID","inPlainEnglish":"We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks.","whoItsFor":["Ages 18 Years to 100 Years","\"post-COVID-19 condition\" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments","physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits","have sufficient education to communicate effectively and are capable of completing the assessments of the study"],"whoShouldSkip":["history of significant cerebrovascular disease","Hachinski Ischemic Score \\> 4","major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments","memantine use (memantine is an NMDAR partial antagonist)","substance (including alcohol) abuse or dependence","delusion, hallucination or delirium symptoms","severe visual or hearing loss"],"whatHappens":"If you join, the listed intervention(s) are DAOIB. The registry lists allocation as na. We will enroll long-COVID patients with cognitive impairments.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Kaohsiung City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.232Z"},{"nctId":"NCT05765812","title":"A Study of Zedoresertib (Debio 0123) in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Zedoresertib (Debio 0123) in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","officialTitle":"A Phase 1/2 Open-label Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Debiopharm International SA","sponsorClass":"INDUSTRY","summary":"The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.\n\nThe primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development.\n\nThe Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of zedoresertib at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.","conditions":["Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","Astrocytoma, Grade III"],"keywords":["WEE1 inhibitor","Glioblastoma, IDH-wildtype, Grade 4, World Health Organization (WHO) 2021","Astrocytoma, IDH-mutant, Grade 3, WHO 2021"],"interventions":[{"type":"DRUG","name":"Zedoresertib"},{"type":"DRUG","name":"Temozolomide"},{"type":"RADIATION","name":"Radiotherapy"}],"enrollment":116,"startDate":"2023-05-15","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Screening Inclusion Criteria for Phase 1 and Phase 2:\n\n* Signed written informed consent approved before undertaking any study-specific procedures.\n* Age ≥18 years of age.\n* Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment.\n* Adequate bone marrow, hepatic, and renal function.\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Willing to practice highly effective methods of contraception.\n* Life expectancy of at least 3 months in the best judgment of the Investigator.\n* Measurable or non-measurable disease as per RANO criteria by gadolinium (Gd)-based contrast-enhanced brain magnetic resonance imaging (MRI).\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤4 mg daily dexamethasone (or ≤25 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n\nAdditional specific inclusion criteria for Phase 1 and Phase 2:\n\n• A maximum of 1 \\[for Phase 1 (Dose Expansion) and phase 2\\] or 2 (Phase 1 Arm A) prior treatment lines of which first-line must be treatment with TMZ-based chemoradiotherapy (TMZ concomitantly with RT).\n\nNote: Only 1 prior line of systemic therapy is allowed; combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line. Prior surgery, radiation, or localized delivery of therapeutic agents (i.e., carmustine-containing wafers \\[GLIADEL®\\]) for first recurrence is allowed.\n\n* Documented disease recurrence or progression by diagnostic biopsy or Gd-based contrast-enhanced brain MRI as per RANO criteria.\n* KPS ≥60.\n\nAdditional specific inclusion criteria for Phase 1 Arm A:\n\n* Participants must have one of the following histopathologically proven diagnoses (WHO 2021):\n* GBM Isocitrate dehydrogenase (IDH)-wildtype Grade 4 which may include secondary GBMs (i.e., those that progress from low-grade gliomas).\n* Astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific inclusion criteria for Phase 1 Arm B and C:\n\n* Participants must have a new, histopathologically proven diagnosis of GBM, IDH-wildtype, Grade 4 (based on WHO 2021), which may include secondary GBMs (i.e., those that progress from low-grade gliomas) if the prior treatment included surgery only.\n* KPS ≥70.\n\nAdditional specific inclusion criteria for Phase 1 dose expansion and Phase 2:\n\n• Participants must have a histopathologically proven diagnosis of GBM, IDH-wildtype Grade 4 WHO 2021\n\nAdditional specific exclusion criteria for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3\n\nAdditional specific exclusion criteria for Phase 1 and Phase 2\n\n* Known contraindication to undergoing for Gd-based, contrast-enhanced MRI.\n* Any anticancer treatment, monoclonal antibodies/biologics, investigational treatment, or RT with curative intent within 28 days prior to starting study treatment.\n* Hypersensitivity to zedoresertib, TMZ, dacarbazine, or any of the excipients found in the formulation for zedoresertib or TMZ.\n* Prior exposure to any WEE1 inhibitor.\n* History of other malignancies requiring active treatment in the last 2 years prior to the first dose of study treatment except for superficial bladder cancers, adequately treated low-risk prostate cancer under active surveillance, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.\n* Left ventricular ejection fraction (LVEF) below 55%.\n\nAdditional specific exclusion criteria for Phase 1 Arm B and C:\n\n* Prior radiation, chemotherapy, biological therapy, interstitial brachytherapy, implanted chemotherapy, therapeutics delivered by local injection or convection-enhanced delivery for GBM.\n* Prior therapy that would result in an overlap of the radiation fields.\n\nAdditional specific exclusion criteria for Phase 1 dose expansion and Phase 2\n\n• Prior treatment with more than 1 line of systemic therapy for GBM, IDH-wildtype, Grade 4 (based on WHO 2021). Combination therapy with TMZ and RT with or without subsequent TMZ maintenance treatment is considered as 1 systemic line.\n\n\\[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.\\]","locations":[{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Langone Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Scott & White Research Institute","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Research Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Donostia","city":"Donostia / San Sebastian","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra (CUN)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra (CUN)","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsspital Zuerich","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Debiopharm International S.A","phone":"+41 21 321 01 11","email":"clinicaltrials@debiopharm.com"}],"primaryOutcomes":["Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs)","Phase 1 (Dose Escalation): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)","Phase 1 (Dose Escalation): Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram (ECHO) Parameters","Phase 1 (Dose Escalation): Change From Baseline in Karnofsky Performance Status (KPS) Score","Phase 1 (Dose Expansion): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE)","Phase 1 (Dose Expansion): Change from Baseline in Tumor Size Assessed by Objective Response (OR) as per Response Assessment in Neuro-oncology (RANO) Criteria","Phase 1 (Dose Expansion): Plasma Concentration of Zedoresertib and its Metabolite","Phase 1 (Dose Expansion): Pharmacodynamic(s) PDy, Change from baseline in Phosphorylated Cell Division Cycle (pCDC2)","Phase 2: Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["chicago-illinois","new-york-new-york","dallas-texas","houston-texas","san-antonio-texas","salt-lake-city-utah","seattle-washington","barcelona-spain","donostia-san-sebastian-spain","madrid-spain","pamplona-spain","valencia-spain","zurich-switzerland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Zedoresertib for Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype","inPlainEnglish":"The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the whether it is safe and how hard side effects are to live with of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm.","whoItsFor":["Ages 18 Years to any","Screening for Phase 1 and Phase 2:","Age ≥18 years of age","Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment","Adequate bone marrow, hepatic, and renal function","Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures","Willing to practice highly effective methods of contraception","Life expectancy of at least 3 months in the best judgment of the Investigator"],"whoShouldSkip":["for Phase 1 Arm A • Prior treatment with more than 2 lines of therapy for GBM, IDH-wildtype, Grade 4, or for astrocytoma, IDH-mutant, Grade 3","Additional specific"],"whatHappens":"If you join, the listed intervention(s) are Zedoresertib, Temozolomide, or Radiotherapy. The registry lists allocation as randomized. The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the whether it is safe and how hard side effects are to live with of these combinations in adult participants with glioblastoma (GBM).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 116 people at 16 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.487Z"},{"nctId":"NCT05765851","title":"A Study of DS-1103a Combination Therapy in Participants With Advanced Solid Tumors","officialTitle":"A Phase 1, 2-Part, Multicenter, First-In-Human Dose-Escalation and Dose-Expansion Study of DS-1103a Combination Therapy in Subjects With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This study will evaluate the safety and efficacy of DS-1103a combination therapy in participants with advanced solid tumors.","conditions":["Advanced Solid Tumor"],"keywords":["Advanced Solid Tumor","DS-1103a","CD47","SIRPa"],"interventions":[{"type":"DRUG","name":"DS-1103a"},{"type":"DRUG","name":"T-DXd"}],"enrollment":128,"startDate":"2023-05-30","completionDate":"2029-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Sign and date the informed consent form (ICF), prior to the start of any study-specific qualification procedures\n* Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old)\n* Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic\n* Is willing and able to provide tumor tissue\n* Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Has adequate organ and bone marrow function within 14 days before the start of study treatment. Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to Cycle 1 Day 1.\n* A woman of childbearing potential (WOCBP) is eligible to participate if she is not pregnant as confirmed by highly sensitive pregnancy test and agrees to adhere to a contraceptive method that is highly effective during the Treatment Period and for at least the time needed to eliminate each study drug after the last dose.\n* A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug.\n* Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions\n\nDose-escalation Phase:\n\n* Has progressed or was non-responsive to available therapies and for which no standard or available anticancer therapy exists\n* Has a pathologically documented HER2-expressing or HER2-mutated solid tumor\n\nDose-expansion Phase:\n\n* Has pathologically documented specific HER2 altered advanced solid tumor type\n* Has received prior therapy as specified in the protocol\n\nExclusion Criteria:\n\n* Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy.\n* Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol\n* Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV\n* Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening\n* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol.\n* Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products or other monoclonal antibodies\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals\n* Is requiring concomitant use of chronic systemic (IV or oral) corticosteroids or other immunosuppressive medications during the study\n* Has received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s)\n* Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results.\n* Has active or uncontrolled human immunodeficiency virus (HIV) infection. Subjects with a positive/reactive HIV antibody and/or known HIV infection at Screening must be tested for HIV RNA viral load and CD4+ T-cell count during the Screening Period (if acceptable by local regulations or IRBs/IECs) and are eligible if certain criteria are met as specified in the protocol.\n* Has active or uncontrolled HBV or HCV. Hepatitis B and C screening testing is required. Participants are eligible only if they meet criteria as specified in the protocol.\n* Has unresolved toxicities from previous anticancer therapy\n* Female who is pregnant, breastfeeding, or planning to become pregnant\n* Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder\n* Any autoimmune, connective tissue or inflammatory disorders\n* Prior complete pneumonectomy\n* Any of the following within 6 months of enrollment: Cerebrovascular accident, transient ischemic attack, or other arterial thromboembolism event\n* Psychological, social, familial, or geographical factors that would prevent regular follow-up\n* Any active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy\n* Uncontrolled hypertension (resting systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg) and/or severe arrhythmia within 28 days before enrollment\n\nDose Expansion (Phase 2)\n\n* Has had prior treatment with antibody-drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor including prior participation in a study involving an antibody-drug conjugate produced by Daiichi Sankyo and/or AstraZeneca.","locations":[{"facility":"Florida Cancer Specialists","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lifespan Cancer Institute","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre, University Health Network","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Léon Bérard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncopole - Institut Claudius Regaud","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gifu University Hospital","city":"Gifu","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Nakatogari","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital Of JFCR","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Contact for Clinical Trial Information","phone":"908-992-6400","email":"CTRinfo@dsi.com"}],"primaryOutcomes":["Number of Participants with Dose-limiting Toxicities (Dose Escalation)","Objective Response Rate Assessed by Blinded Independent Central Review Following DS-1103a Combination Therapy (Dose Expansion)","Number of Participants with Dose-limiting Toxicities Following DS-1103a Combination Therapy (Dose Expansion; Cohort 2 Safety Run In and Japanese Population Tolerability Assessments)","Overall Number of Participants With Treatment-emergent Adverse Events and Serious Adverse Events (Dose Escalation and Expansion; Cohort 2 Safety Run In and Japanese Population Tolerability Assessments)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["sarasota-florida","new-york-new-york","providence-rhode-island","salt-lake-city-utah","fairfax-virginia","toronto-canada","lyon-france","toulouse-france","gifu-japan","nakatogari-japan","osaka-japan","tokyo-japan","barcelona-spain","tainan-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 1: testing DS-1103a for Advanced Solid Tumor","inPlainEnglish":"This study will measure the safety and how well it works of DS-1103a combination therapy in participants with advanced solid tumors.","whoItsFor":["Ages 18 Years to any","Adults ≥18 years of age at the time the ICF is signed (please follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old)","Pathologically documented HER2-expressing or HER2-mutated (activating mutation) solid tumor that is unresectable or metastatic","Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment","Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1","Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment","A male participant capable of producing sperm is eligible to participate if he agrees to adhere to the contraception methods as specified in the protocol and avoids donating sperm during the Treatment Period and for at least the time needed to eliminate each study drug","Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions"],"whoShouldSkip":["Has had prior treatment with an anti-CD47 or anti-signal regulatory protein α (SIRPα) therapy","Has an inadequate treatment washout period prior to start of study treatment as specified in the protocol","Medical history of myocardial infarction (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV","Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)","Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening","Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms","Has multiple primary malignancies within 3 years. Exceptions are specified in the protocol"],"whatHappens":"If you join, the listed intervention(s) are DS-1103a, or T-DXd. The registry lists allocation as randomized. This study will measure the safety and how well it works of DS-1103a combination therapy in participants with advanced solid tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 128 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.348Z"},{"nctId":"NCT05768139","title":"First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","officialTitle":"First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations.\n\nPart 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer.\n\nEach study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.","conditions":["Breast Cancer","Solid Tumors, Adult"],"keywords":["Breast Neoplasms","Neoplasms by Site","Neoplasms","Breast Diseases","HER2-negative breast cancer","HR-positive breast cancer","Gynecologic cancer","Endometrial cancer","Ovarian cancer","Cervical cancer","Head and neck cancer","Head and neck squamous cell carcinoma","Fulvestrant","Antineoplastic Agents","PI3Kα","PI3K alpha","PI3Kα mutation","Alpelisib","STX-478","PI3Kα inhibitor","Estrogen Receptor Antagonists","Estrogen Antagonists","Hormone Receptor Antagonists","Hormone Antagonists","Hormones, Hormone Substitutes, and Hormone Antagonists","Physiological Effects of Drugs","Palbociclib","Ribociclib","PIK3CA","PIK3CA mutation","Aromatase inhibitor","Letrozole","Anastrozole","Exemestane","Imlunestrant","Inavolisib","Capivasertib","Abemaciclib"],"interventions":[{"type":"DRUG","name":"STX-478"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Anastrozole"},{"type":"DRUG","name":"Exemestane"},{"type":"DRUG","name":"Tamoxifen"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Imlunestrant"},{"type":"DRUG","name":"Metformin"}],"enrollment":880,"startDate":"2023-04-17","completionDate":"2030-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)\n* Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening\n* Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types)\n* Is ≥18 years of age at the time of signing the ICF\n* Has an ECOG performance status score of 0 or 1 at screening\n* Has adequate organ function as defined per protocol\n\nKey Exclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied\n* Has symptomatic brain or spinal metastases\n* Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or FBG ≥140 mg/dL \\[7.7 mmol/L\\] and/or requiring or required insulin).\n* Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances\n* Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days. Endocrine therapy does not require a washout period if the patient is enrolling in a cohort with the same combination endocrine therapy.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy within 14 days before the initiation of study treatment","locations":[{"facility":"Ellison Clinic at Saint John's","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center at Mission Bay","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale-New Haven Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Florida Cancer Specialists ORLANDO/DDU","city":"Lake Mary","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute, Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louisiana State University Health Sciences Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UH Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stefanie Spielman Comprehensive Breast Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Cancer Institute Franz Clinic","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The West Clinic, PLLC dba West Cancer Center","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Crowley Cancer Research Center","city":"Dallas","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Texas Oncology-Baylor Charles A. 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Center","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Hirakata","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Kōtō City","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyoto University Hospital","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Netherlands Cancer Institute","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus MC","city":"Rotterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Quiron Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou 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Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Quironsalud Madrid","city":"Pozuelo de Alarcón","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Sant Joan de Reus","city":"Reus","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of participants who experience at least 1 Dose Limiting Toxicity (DLT)","Proportion of participants who experience at least 1 DLT during the first 28 days of treatment","Objective response rate (ORR) defined as the percentage of participants with partial response or complete response based on RECIST 1.1","Incidence of TEAEs/SAEs ≥ grade 2","Frequency of TEAEs according to CTCAE v5.0 criteria"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer","cervical-cancer","endometrial-cancer","head-and-neck-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["los-angeles-california","san-francisco-california","aurora-colorado","new-haven-connecticut","lake-mary-florida","tampa-florida","atlanta-georgia","iowa-city-iowa","new-orleans-louisiana","boston-massachusetts","detroit-michigan","grand-rapids-michigan","kansas-city-missouri","st-louis-missouri","new-york-new-york","cleveland-ohio","columbus-ohio","portland-oregon","germantown-tennessee","nashville-tennessee","dallas-texas","houston-texas","san-antonio-texas","west-valley-city-utah","fairfax-virginia","anderlecht-belgium","leuven-belgium","bordeaux-france","lyon-france","marseille-france","nice-france","toulouse-france","villejuif-france","erlangen-germany","dublin-ireland","alessandria-italy","brescia-italy","milan-italy","monza-italy","pisa-italy","ravenna-italy","roma-italy","verona-italy","fukuoka-japan","hirakata-japan","k-t-city-japan","kyoto-japan","amsterdam-netherlands","rotterdam-netherlands","barcelona-spain","logro-o-spain","madrid-spain","pozuelo-de-alarc-n-spain","reus-spain","seville-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing STX-478 for Breast Cancer","inPlainEnglish":"Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as this drug alone in participants with advanced solid tumors.","whoItsFor":["Ages 18 Years to any","Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)","Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening","Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types)","Is ≥18 years of age at the time of signing the ICF","Has an how well you can do daily activities (ECOG score) score of 0 or 1 at screening","Has adequate organ function as defined per protocol"],"whoShouldSkip":["Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied","Has symptomatic brain or spinal metastases","Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or FBG ≥140 mg/dL \\[7.7 mmol/L\\] and/or requiring or required insulin)","Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances","Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy","Has had radiotherapy within 14 days before the initiation of study treatment"],"whatHappens":"If you join, the listed intervention(s) are STX-478, Fulvestrant, or Ribociclib. The registry lists allocation as randomized. Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 880 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.732Z"},{"nctId":"NCT05776927","title":"A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","officialTitle":"A Double-dummy, Double-blind, Randomized, Active Controlled, Two-way Cross-over Study With 12 Week Treatment Duration Period, to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Compared to Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.","conditions":["Asthma"],"keywords":["Asthma","Adolescent","QVM149","Pediatric","LABA","LAMA","ICS","Triple Combination"],"interventions":[{"type":"DRUG","name":"QVM149"},{"type":"DRUG","name":"Salmeterol Xinafoate / Fluticasone Propionate"},{"type":"DRUG","name":"Placebo to QVM149"},{"type":"DRUG","name":"Placebo to salmeterol xinafoate / fluticasone propionate"}],"enrollment":188,"startDate":"2026-08-04","completionDate":"2028-12-30","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion criteria:\n\n* Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit\n* Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening.\n* Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening\n* Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening\n* Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit\n* Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization\n\nKey Exclusion criteria:\n\n* Participants who have had a severe asthma attack/exacerbation requiring systemic steroids OR hospitalization (\\> 24 hours) OR emergency room (ER) visit (≤ 24 hours) within 6 weeks of screening. If participants experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between screening and end of run-in they may be re-screened 6 weeks after recovery from the exacerbation\n* Participants who have ever required intubation for a severe asthma attack/exacerbation\n* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis\n* Participants with Type I diabetes or uncontrolled Type II diabetes\n* Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in\n* Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months\n* Participants with a history of long QT syndrome or a family history of a first degree relative with sudden cardiac death under the age of 50 years, or participants whose QTc measured at run-in or at baseline (prior to randomization) (Fridericia method) is prolonged (\\> 450 msec for males and \\> 460 msec for females) and confirmed by a central assessor or the inability to determine the QT interval corrected by Fridericia's formula (QTcF) interval (these participants should not be re-screened)\n* Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the exclusion criteria\n* Use of long-acting muscarinic antagonist (LAMA) within 3 months prior to screening\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Novartis Investigative Site","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Wesel","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bielefeld","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Szeged","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tarnów","state":"Poland","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative 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FEV1"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["rosario-argentina","strasbourg-france","wesel-germany","bielefeld-germany","szeged-hungary","tarn-w-poland","bialystok-poland","krakow-poland","lublin-poland","piaseczno-poland","torun-poland","bucharest-romania","bratislava-slovakia","bansk-bystrica-slovakia","ko-ice-slovakia","east-london-south-africa","germiston-south-africa","krugersdorp-south-africa","lenasia-south-africa","paarl-south-africa","cape-town-south-africa","pretoria-south-africa","santiago-compostela-spain","sabadell-spain","seville-spain","kaohsiung-city-taiwan"],"enrichment":{"headline":"Phase 3: testing QVM149 for Asthma","inPlainEnglish":"This study wants to measure the how well it works and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.","whoItsFor":["Ages 12 Years to 17 Years","Male and female adolescent participants aged from ≥ 12 years old to less than 18 years old at screening visit","Participants with a documented diagnosis of persistent asthma (according to Global Initiative for Asthma GINA 2024) for a period of at least 1 year prior to screening","Participants who have used medium or high dose ICS with LABA in combination (GINA 2024) for asthma for at least 3 months and at stable doses for at least 1 month prior to screening","Participants must be symptomatic / inadequately controlled according to the Investigator's opinion despite treatment with medium or high stable doses of ICS with LABA in combination (GINA 2024) before screening","Participants who demonstrate an increase in FEV1 of ≥ 12% within 15 to 30 minutes after administration of 200-400 μg salbutamol/180-360 μg albuterol at run-in visit","Pre-bronchodilator FEV1 ≥ 50% of the predicted normal value for the participant according to American Thoracic Society/European Respiratory Society (ATS/ERS) 2019 criteria at both run-in and before randomization"],"whoShouldSkip":["Participants who have ever required intubation for a severe asthma attack/exacerbation","Participants with a history of chronic lung diseases other than asthma, including (but not limited to) sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis","Participants with Type I diabetes or uncontrolled Type II diabetes","Participants who have a clinically significant laboratory abnormality as per investigator judgement before the end of run-in","Participants with a history of myocardial infarction (this should be confirmed clinically by the Investigator) within the previous 12 months","Female participants of childbearing potential defined as all females physiologically capable of becoming pregnant (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of contraception as defined in the"],"whatHappens":"If you join, the listed intervention(s) are QVM149, Salmeterol Xinafoate / Fluticasone Propionate, or Placebo to QVM149. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of indacaterol acetate / glycopyrronium bromide / mometasone furoate (QVM149) compared to salmeterol xinafoate / fluticasone propionate in children from 12 to less than 18 years of age with asthma with pre-bronchodilator FEV1 ≥ 50 % of the predicted normal value for the participant.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 188 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.339Z"},{"nctId":"NCT05780450","title":"Effectiveness of Transcranial Direct Current in Patients With Persistent COVID-19 With Headaches and Chronic Pain.","officialTitle":"Effectiveness of Transcranial Direct Current (tDCS) Treatment in Patients With Persistent Covid Who Present Headaches and Chronic Body Pain.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Fundación Universidad Católica de Valencia San Vicente Mártir","sponsorClass":"OTHER","summary":"This study aims to verify the efficacy/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia. As you can see, in the case of patients with Long Covid, we find several of these symptoms, so it is suggested that if transcranial direct current therapy (TDCS) gives such good results in relieving these symptoms, why couldn't it give such good results and help just as much in patients with Long Covid, since many of the symptoms are the same, even if the origin or cause is different.","conditions":["COVID-19","Long COVID","Long Covid19","SARS CoV 2 Infection","Persistent COVID-19","Migraine Disorders","Headaches Chronic","Cluster Headache","Arthralgia","Myalgia","Chronic Pain","Post-COVID-19 Syndrome","Post COVID-19 Condition","Sleep Quality","Insomnia"],"keywords":["Transcranial Direct Current Stimulation","tDCS","Covid Persistente"],"interventions":[{"type":"DEVICE","name":"Transcranial Direct Current Therapy (tDCS)"},{"type":"DEVICE","name":"Sham (No Treatment)"}],"enrollment":87,"startDate":"2023-04-01","completionDate":"2026-11-05","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with Persistent Covid\n* Men and women\n* All ages from 16 years old\n* Patients who passed the Covid in its acute phase in an asymptomatic, mild and severe way.\n\nExclusion Criteria:\n\n* Patients without confirmation with positive PCR in the acute phase of Covid-19\n* Patients with Persistent Covid who do not have at least one of these symptoms: migraines, headaches, chronic pain, neuropathic pain, arthralgia, myalgias\n* Patients with pacemaker / defibrillator\n* Patients with brain implants\n* Patients with cranial fractures\n* Pregnant","locations":[{"facility":"Clínica Paiporta","city":"Paiporta","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Escuela de Doctorado. Universidad Católica de Valencia San Vicente Mártir. (Doctoral School. Catholic University of Valencia San Vicente Mártir)","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"LAURA GARCÍA MARTÍNEZ","phone":"+34691635330","email":"lauragarciamartinez@mail.ucv.es"}],"primaryOutcomes":["CHANGE FROM PRE-TREATMENT DEGREE CHRONIC BODY PAIN AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS","CHANGE FROM PRE-TREATMENT INTENSE MIGRAINES OR HEADACHES AT INMEDIATE POST-TREATMENT, 1 MONTH, 3 MONTHS AND 6 MONTHS"],"hasResults":false,"conditionSlugs":["migraine","long-covid"],"drugSlugs":[],"locationSlugs":["paiporta-spain","valencia-spain"],"enrichment":{"headline":"Not a traditional drug phase: Transcranial Direct Current Therapy (tDCS) for COVID-19","inPlainEnglish":"This study aims to verify the how well it works/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems. Transcranial direct current stimulation is used in the field of Physiotherapy and Rehabilitation, with results that have proven to be effective for treating patients suffering from symptoms like migraines, headaches, chronic pain, fibromyalgia, or chronic neuropathic pain and insomnia.","whoItsFor":["Ages 16 Years to any","Patients with Persistent Covid","All ages from 16 years old","Patients who passed the Covid in its acute phase in an asymptomatic, mild and severe way"],"whoShouldSkip":["Patients without confirmation with positive PCR in the acute phase of Covid-19","Patients with Persistent Covid who do not have at least one of these symptoms: migraines, headaches, chronic pain, neuropathic pain, arthralgia, myalgias","Patients with pacemaker / defibrillator","Patients with brain implants","Patients with cranial fractures"],"whatHappens":"If you join, the listed intervention(s) are Transcranial Direct Current Therapy (tDCS), or Sham (No Treatment). The registry lists allocation as randomized. This study aims to verify the how well it works/effectiveness of treatment with transcranial direct current stimulation (TDCS) in patients with Long Covid who experience headaches, migraines, and chronic pain, such as arthralgia and myalgia, as well as sleep problems.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 87 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.303Z"},{"nctId":"NCT05784753","title":"HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction","officialTitle":"HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Nebraska","sponsorClass":"OTHER","summary":"The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.","conditions":["HFpEF - Heart Failure With Preserved Ejection Fraction"],"keywords":["exercise training","patient adherence","coaching"],"interventions":[{"type":"BEHAVIORAL","name":"HEART Camp"},{"type":"BEHAVIORAL","name":"HEART Camp Connect"}],"enrollment":300,"startDate":"2023-11-20","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of heart failure with an ejection fraction greater than or equal to 50\n* Echocardiogram in prior 24 months\n* Stable pharmacologic therapy in the past 30 days\n* Any of the following evidence to confirm HFpEF - Score\\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF\n\nExclusion Criteria:\n\n* Life-limiting illness precluding study completion\n* Clinical evidence of decompensated heart failure\n* Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents\n* Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks\n* Orthopedic or neuromuscular disorders preventing aerobic exercise\n* Cardiopulmonary exercise test results that preclude safe exercise\n* Unwilling/unable to complete pre-randomization procedures\n* Pregnancy\n* Implantable cardioverter defibrillator","locations":[{"facility":"Henry Ford Health System","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Windy W Alonso, PhD","phone":"402-559-8342","email":"windy.alonso@unmc.edu"}],"primaryOutcomes":["Exercise Adherence","Exercise Adherence","Exercise Adherence"],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["detroit-michigan","omaha-nebraska","charlottesville-virginia"],"enrichment":{"headline":"Not a traditional drug phase: HEART Camp for HFpEF - Heart Failure With Preserved Ejection Fraction","inPlainEnglish":"The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood.","whoItsFor":["Ages 18 Years to any","Diagnosis of heart failure with an ejection fraction greater than or equal to 50","Echocardiogram in prior 24 months","Stable pharmacologic therapy in the past 30 days"],"whoShouldSkip":["Life-limiting illness precluding study completion","Clinical evidence of decompensated heart failure","Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents","Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks","Orthopedic or neuromuscular disorders preventing aerobic exercise","Cardiopulmonary exercise test results that preclude safe exercise","Unwilling/unable to complete pre-randomization procedures"],"whatHappens":"If you join, the listed intervention(s) are HEART Camp, or HEART Camp Connect. The registry lists allocation as randomized. The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.424Z"},{"nctId":"NCT05785169","title":"Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being","officialTitle":"Ending the HIV Epidemic: An All-facility Intervention for Patient and Healthcare Staff Well-being","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Columbia University","sponsorClass":"OTHER","summary":"The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial. Clinic members will participate in interactive trainings to raise awareness of and reduce stigma, from the clinic policy level to individual attitudes. Clinic members and select patients will complete self-administered surveys every 6 months over 24 months.","conditions":["Stigma","HIV","Well-Being, Psychological"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"All-facility Training"}],"enrollment":1000,"startDate":"2025-01-27","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Selected Ryan White Clinics. Selection based on the following:\n\nFirst, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey.\n\nWithin each clinic, both clinic staff and patients will be invited to participate.\n\nExclusion Criteria:\n\n* Non-Ryan White Clinics\n* Clinics not located in the geographical area of interest\n* Clinics that are not interested in participating","locations":[{"facility":"Columbia University School of Nursing","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Corina T Lelutiu-Weinberger, PhD","phone":"212-305-5756","email":"cl4265@cumc.columbia.edu"},{"name":"Felicia A Browne, ScD","phone":"919-541-6596","email":"fbrowne@rti.org"}],"primaryOutcomes":["Change in Stigma Index (SI)"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: All-facility Training for Stigma","inPlainEnglish":"The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment. Five RWHAP clinics will be selected for this trial.","whoItsFor":["Ages 18 Years to any","Selected Ryan White Clinics. Selection based on the following:","First, clinic leaders will complete a 15-min Site Characteristics Survey, assessing suitability for participation and clinic comparability. Staff and leadership at Ryan White clinics will next complete an anonymous 15-minute Eligibility Survey","Within each clinic, both clinic staff and patients will be invited to participate"],"whoShouldSkip":["Non-Ryan White Clinics","Clinics not located in the geographical area of interest","Clinics that are not interested in participating"],"whatHappens":"If you join, the listed intervention(s) are All-facility Training. The registry lists allocation as na. The scope of this study is to engage Ryan White HIV/AIDS Program (RWHAP) funded organizations in the South/East US to co-develop context-responsive programs utilizing evidence-informed interventions to reduce stigma against living with HIV (PLH) who have difficulties accessing and remaining engaged in life-saving treatment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,000 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.542Z"},{"nctId":"NCT05792722","title":"Evaluating Safety and Efficacy of Prostate-sparing Radical Cystectomy","officialTitle":"A Prospective, Randomized Trial Comparing Prostate Capsule-sparing and Nerve-sparing Radical Cystectomy in Patients With Bladder Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomized to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy. Patients will be monitored following standard of care guidelines and clinical data will be collected. Patients in both groups will be asked to complete an erectile function questionnaire at multiple timepoints. Patients who receive an orthotopic neobladder will be asked to complete a questionnaire to monitor urinary function at multiple timepoints. Patient adverse events will be monitored to ensure patients safety.","conditions":["Bladder Cancer"],"keywords":["Radical Cystectomy","Prostate Capsule-Sparing Cystectomy","Nerve-Sparing Cystectomy","Male"],"interventions":[{"type":"PROCEDURE","name":"Prostate capsule-sparing radical cystectomy"},{"type":"PROCEDURE","name":"Nerve sparing radical cystectomy"}],"enrollment":70,"startDate":"2023-10-25","completionDate":"2028-07","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy\n* Variant histologies of bladder cancer permitted\n* Neoadjuvant therapy permitted\n* Age \\> 18 years old\n* Ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients that are not candidates for cystectomy\n* Moderate to severe erectile dysfunction with SHIM score \\<17\n* Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra\n* Prior pelvic radiation\n* Confirmed prostate cancer:\n* Patients with abnormal Digital rectal exam (DRE), PSA \\>3 or Prostate Imaging Reporting \\& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer\n* Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:\n* ≥1 first-, second-, or third-degree relative with: breast cancer at age ≤50 y, colorectal or endometrial cancer at age ≤50 y, male breast cancer at any age, ovarian cancer at any age, exocrine pancreatic cancer at any age, metastatic, regional, very-high-risk, high-risk prostate cancer at any age\n* ≥1 first-degree relative (father or brother) with: prostate cancer at age ≤60 y\n* ≥2 first-, second-, or third-degree relatives with: breast cancer at any age, prostate cancer at any age\n* ≥3 first- or second-degree relatives with: Lynch syndrome-related cancers, especially if diagnosed\n* Patients with Lynch syndrome","locations":[{"facility":"Sibley Memorial Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Armine Smith, MD","phone":"202-660-5561","email":"asmit165@jhmi.edu"},{"name":"Domani Rodriguez","phone":"","email":"drodri59@jh.edu"}],"primaryOutcomes":["Change in Functional Outcomes as assessed by the Sexual Health Inventory for Men (SHIM)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Prostate capsule-sparing radical cystectomy for Bladder Cancer","inPlainEnglish":"The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy. Patients will be randomly assigned to one of two groups: prostate capsule-sparing radical cystectomy or nerve-sparing radical cystectomy.","whoItsFor":["Ages 18 Years to any","Men only","Subjects with pathologically confirmed bladder cancer scheduled for radical cystectomy","Variant histologies of bladder cancer permitted","Neoadjuvant therapy permitted","Age \\> 18 years old"],"whoShouldSkip":["Patients that are not candidates for cystectomy","Moderate to severe erectile dysfunction with SHIM score \\<17","Bladder cancer with bladder neck or prostatic involvement, including cancer in the prostatic urethra","Prior pelvic radiation","Confirmed prostate cancer:","Patients with abnormal Digital rectal exam (DRE), PSA \\>3 or Prostate Imaging Reporting \\& Data System (PIRADS) 4 lesions on prostate Multiparametric MRI (mpMRI) will undergo prostate biopsy to rule out prostate cancer","Increased genetic risk of prostate cancer per National Comprehensive Cancer Network (NCCN) guidelines:"],"whatHappens":"If you join, the listed intervention(s) are Prostate capsule-sparing radical cystectomy, or Nerve sparing radical cystectomy. The registry lists allocation as randomized. The purpose of this clinical trial is to determine if prostate-capsule-sparing cystectomy improves functional outcomes without comprising oncologic outcomes in male patients receiving a radical cystectomy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 70 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.310Z"},{"nctId":"NCT05795101","title":"TRUDI: TDXD+Durva in HER2+/Low IBC","officialTitle":"TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Filipa Lynce, MD","sponsorClass":"OTHER","summary":"The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.\n\nThe names of the study drugs involved in this study are:\n\n* Trastuzumab deruxtecan\n* Durvalumab","conditions":["Invasive Breast Cancer","Inflammatory Breast Cancer Stage III","HER2-positive Breast Cancer","HER2 Low Breast Adenocarcinoma","Breast Cancer"],"keywords":["Invasive Breast Cancer","Inflammatory Breast Cancer Stage III","HER2-positive Breast Cancer","HER2 Low Breast Adenocarcinoma","Breast Cancer"],"interventions":[{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Durvalumab"}],"enrollment":63,"startDate":"2023-05-04","completionDate":"2027-12-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have a histological or cytological diagnosis of invasive breast cancer.\n* All histologic subtypes are eligible.\n* Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months\n* HER2-positive status as determined locally by the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be determined by either fluorescence in situ hybridization \\[FISH\\] or dual in situ hybridization \\[DISH\\])\n* Any ER and PR expressions are permitted but must be known\n* Participants must be treatment-naïve\n* Participants must agree to undergo two research biopsies of the tumor (if safely accessible, as determined by the treating investigator): at baseline (prior to the first treatment) and after the first week of treatment on C1D8. Previously collected archival tissue will also be obtained on all participants. For participants for whom the tumor is not safely accessible, this archival tissue needs to be located and availability confirmed at time of registration.\n* Pre- and postmenopausal women or male patients ≥ 18 years of age\n* ECOG performance status 0-1 (Karnofsky \\> 60%, see Appendix A).\n* LVEF ≥ 50% within 28 days prior to enrollment\n* Participants must have normal organ and marrow function prior to enrollment as defined below:\n\n  * Absolute neutrophil count ≥2,000/mcL\n  * Platelets ≥100,000/mcL\n  * Hemoglobin ≥ 9.0 g/dl\n  * INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant\n  * Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)\n  * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN\n  * Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.\n  * Serum albumin ≥2.5 g/dL\n  * International normalized ratio (INR)/prothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤1.5 × ULN\n* Women of childbearing potential (WOCBP) and WOCBP who are partners of male participants must agree to use one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception for the duration of study treatment with durvalumab and 7 months after the last dose of study treatment\n* Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with durvalumab and 4 months after the last dose of study treatment\n* Must have a life expectancy of at least 12 weeks\n* Body weight \\>30 kg\n* The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document\n\nExclusion Criteria:\n\n* Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy\n* Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment.\n* Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies.\n* Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.\n* Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.\n* Participant has a medical condition that requires chronic systemic steroid therapy (\\> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and has required such therapy in the last 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic therapy.\n* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], diverticulitis \\[with the exception of diverticulosis\\], systemic lupus erythematosus, sarcoidosis syndrome, Wegener syndrome \\[granulomatosis with polyangiitis\\], Graves' disease, and rheumatoid arthritis, hypophysitis, uveitis, etc). The following are exceptions to this criterion:\n\n  \\-- Patients with vitiligo or alopecia, Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, Patients with any chronic skin condition that does not require systemic therapy, Patients with celiac disease controlled by diet alone, who may also be included, but only after consultation with the Principal Investigator, Patients without active disease in the last 5 years, who may also be included but only after consultation with the Principal Investigator\n* History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and prior pneumonectomy\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec on screening EKG\n* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval\n* Any of the following procedures or conditions in the 6 months prior to enrollment: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure (New York Heart Association Functional Classification Grade ≥2), and stroke. Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial infarction related symptoms, should have a cardiology consultation before enrollment to rule out myocardial infarction.\n* Cardiac ejection fraction outside institutional range of normal or \\<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive).\n* History of another primary malignancy, except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, Adequately treated carcinoma in situ without evidence of disease\n* History of venous thromboembolism in the past 3 months.\n* History of active primary immunodeficiency.\n* Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] result) or hepatitis C virus (HCV). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible. Patients positive for hepatitis C antibody are eligible only if the polymerase chain reaction is negative for HCV RNA. Some medications used for these conditions have drug-drug interactions with the study treatment.\n* Known to have previously tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)(HIV testing is not required for participation on this study)\n* Receipt of a live vaccine within 30 days prior to study treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine is allowed.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n* Use of potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)\n* Use of hydroxychloroquine in \\<14 days prior to Day 1 of trastuzumab deruxtecan treatment\n* History of leptomeningeal carcinomatosis\n* Female patients who are pregnant, breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last dose of durvalumab and at least 7 months after the final administration of trastuzumab deruxtecan due to the potential for teratogenic effects. And unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Filipa Lynce, MD","phone":"(617) 632-3800","email":"filipa_lynce@dfci.harvard.edu"}],"primaryOutcomes":["Pathological complete response (pCR) Rate"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["boston-massachusetts","houston-texas"],"enrichment":{"headline":"Phase 2: testing Trastuzumab deruxtecan for Invasive Breast Cancer","inPlainEnglish":"This study wants to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of the study drugs involved in this study are: * Trastuzumab deruxtecan * Durvalumab","whoItsFor":["Ages 18 Years to any","Women only","Participants must have a histological or cytological diagnosis of invasive breast cancer","All histologic subtypes are eligible","Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months","Any ER and PR expressions are permitted but must be known","Participants must be treatment-naïve","Pre- and postmenopausal women or male patients ≥ 18 years of age","how well you can do daily activities (ECOG score) 0-1 (Karnofsky \\> 60%, see Appendix A)"],"whoShouldSkip":["Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy","Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment","Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies","Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery","History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening","Corrected QT interval (QTcF) prolongation to \\> 470 msec on screening EKG","Cardiac ejection fraction outside institutional range of normal or \\<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition \\[MUGA\\] scan if an echocardiogram cannot be performed or is inconclusive)"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab deruxtecan, or Durvalumab. The registry lists allocation as randomized. This study wants to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 63 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.367Z"},{"nctId":"NCT05796388","title":"A Study of Virtual Reality and Linaclotide for IBS-C","officialTitle":"A Pilot Study to Evaluate the Efficacy and Safety of Virtual Reality in Combination With Linaclotide for the Treatment of Adults With IBS and Constipation Predominance","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"The purpose of this study is to determine if adult patients with IBS-C will report an overall greater improvement in IBS symptoms and quality of life when treated with a combination of linaclotide (standard of care medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (placebo) VR therapy.","conditions":["Irritable Bowel Syndrome With Constipation"],"keywords":["Virtual reality","IBS-C"],"interventions":[{"type":"DEVICE","name":"Virtual Reality"}],"enrollment":65,"startDate":"2024-05-31","completionDate":"2026-10","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult men and women (18-70) who meet Rome IV criteria for IBS-C.\n* Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment.\n\nExclusion Criteria:\n\n* Patients will be excluded from the study if they have a comorbid disorder that may confound the diagnosis of IBS, including celiac disease, inflammatory bowel disease, autoimmune disorders that affect the GI system, history of bowel resection, HIV/AIDS, diabetes with HgA1c \\>7.0, neuroendocrine tumors, microscopic colitis, lactase deficiency, eosinophilic bowel disease, acute intermittent porphyria, or any other condition that a licensed physician believes can mimic IBS symptoms and undermine diagnostic certitude.\n* Patients with severe depression, defined as a score equal to or greater than two standard deviations (SDs) on the NIH PROMIS depression scale, or those with suicidal ideations, will also be excluded and provided with standard resources to support their mental health and referred back to their primary care provider, a member of the study team will follow up with the PCP to ensure the communication was received.\n* Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia.\n* Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,\n* have a known seizure disorder,\n* if symptoms are thought to represent an organic disorder,\n* if they have had prior surgery to the colon,\n* if symptoms represent a known pelvic floor disorder,\n* if the patient is abusing alcohol,\n* or if the patient cannot actively participate in the study for any other reason (e.g., inability to understand English as the VR program is in English only).\n* Patients previously treated with linaclotide who reported side effects,\n* those currently on linaclotide (any dose),\n* and those who did not note an improvement in IBS-C symptoms in the past while on linaclotide will also be excluded.","locations":[{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brian Lacy, MD, PhD","phone":"904-953-6970","email":"lacy.brian@mayo.edu"},{"name":"Kristen Lozano","phone":"904-953-4725","email":"Lozano.Kristen@mayo.edu"}],"primaryOutcomes":["Changes in IBS symptoms"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["jacksonville-florida"],"enrichment":{"headline":"Not a traditional drug phase: Virtual Reality for Irritable Bowel Syndrome With Constipation","inPlainEnglish":"This study wants to determine if adult patients with IBS-C will report an overall greater improvement in IBS symptoms and quality of life when treated with a combination of linaclotide (standard of care medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (dummy treatment (placebo)) VR therapy.","whoItsFor":["Ages 18 Years to 70 Years","Adult men and women (18-70) who meet Rome IV criteria for IBS-C","Patients will be required to score below 65 points on the IBS Quality of Life (IBS-QOL) instrument, indicating a score consistent with at least moderate HRQOL (Health-related quality of life) impairment"],"whoShouldSkip":["Patients using regular doses of opioid medications will also be excluded given the often-severe impact of opioids on GI motility and potential for pharmacological visceral hyperalgesia","Patients will also be excluded from the study if they do not meet Rome IV criteria for IBS-C,","have a known seizure disorder,","if symptoms are thought to represent an organic disorder,","if they have had prior surgery to the colon,","if symptoms represent a known pelvic floor disorder,","if the patient is abusing alcohol,"],"whatHappens":"If you join, the listed intervention(s) are Virtual Reality. The registry lists allocation as randomized. This study wants to determine if adult patients with IBS-C will report an overall greater improvement in IBS symptoms and quality of life when treated with a combination of linaclotide (standard of care medication) and immersive virtual reality (VR) therapy compared to those treated with linaclotide and sham (dummy treatment (placebo)) VR therapy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 65 people at Jacksonville. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.442Z"},{"nctId":"NCT05805371","title":"PSCA-Targeting CAR-T Cells Plus or Minus Radiation for the Treatment of Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer","officialTitle":"A Phase 1b Study Evaluating Combinations With PSCA-Targeting Chimeric Antigen Receptor (CAR)-T Cells for Patients With PSCA+ Metastatic Castration-Resistant Prostate Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. Giving PSCA-targeting CAR T-cells, with or without radiation, may kill more tumor cells in men with castration-resistant prostate cancer.","conditions":["Castration-Resistant Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage IVB Prostate Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes"},{"type":"PROCEDURE","name":"Biopsy"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Scan"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"RADIATION","name":"External Beam Radiation Therapy"},{"type":"PROCEDURE","name":"Leukapheresis"},{"type":"PROCEDURE","name":"Lymphodepletion Therapy"}],"enrollment":21,"startDate":"2024-10-09","completionDate":"2029-11-11","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative (brown)\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n\n    * Note: For research participants who do not speak English, a short form consent may be used with a City of Hope (COH) certified interpreter/translator to proceed with screening and leukapheresis, while the request for a translated main consent is processed. However, the research participant is allowed to proceed with lymphodepletion and CAR T cell infusion only after the translated main consent form is signed\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (KPS) \\>= 70%\n* Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \\< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \\[LHRH\\] agonist/antagonist therapy)\n\n  * Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)\n\n    * Fresh or archival biopsy samples may be tested for PSCA expression during screening for eligibility purposes. The results from soft tissue biopsies will be used to confirm eligibility for participants who have a soft-tissue lesion biopsy obtained, but bone biopsy staining results will not impact eligibility since immunohistochemistry (IHC) staining for PSCA has not been optimized in bone specimens. Subjects who undergo bone biopsy on study will be qualified based on the archival tissue result\n  * Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide):\n\n    * Rising prostate specific antigen (PSA) documented on 2 occasions at least 7 days apart, with absolute increase \\> 2 ng/dL despite testosterone \\< 50 OR\n    * Radiographic evidence of new metastatic foci on CT or bone scan, or soft tissue progression by Response Evaluation Criteria in Solid Tumors (RECIST)\n  * For treatment plan 2, subjects must have at least one and up to 3 metastatic lesions which have not previously been radiated and which is safe for treatment with radiation 16 gray (Gy) in 2 fractions\n* Fully recovered from the acute toxic effects (except alopecia) to =\\< grade 1 to prior anti-cancer therapy\n* If there has been prior chemotherapy, at least 2 weeks must have elapsed prior to leukapheresis\n* Prior radiotherapy is allowed provided it was not administered to the only evaluable site of disease and was completed \\> 14 days prior to leukapheresis\n* No known contraindications to leukapheresis, steroids or tocilizumab\n* Absolute neutrophil count (ANC) \\>= 1,000/mm\\^3 (within 42 days prior to enrollment)\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment\n* Platelets \\>= 100,000/mm\\^3 (within 42 days prior to enrollment) NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment\n* Total serum bilirubin =\\< 2.0 mg/dL (within 42 days prior to enrollment)\n\n  * Patients with Gilbert syndrome may be included if their total bilirubin is =\\< 3.0 x upper limit of normal (ULN) and direct bilirubin =\\< 1.5 x ULN\n* Aspartate aminotransferase (AST) =\\< 2.5 x ULN (within 42 days prior to enrollment)\n* Alanine aminotransferase (ALT) =\\< 2.5 x ULN (within 42 days prior to enrollment)\n* Creatinine clearance of \\>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 42 days prior to enrollment)\n* Corrected QT interval (QTc) =\\< 480 ms\n\n  * Note: to be performed within 28 days prior to day 1 of protocol therapy\n* Cardiac function (12 lead- electrocardiogram \\[ECG\\]) without acute abnormalities requiring investigation or intervention (within 42 days prior to enrollment)\n* Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (rapid plasma reagin \\[RPR\\])\n\n  * If positive, hepatitis C ribonucleic acid (RNA) quantitation must be performed OR\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * Note infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Agreement by males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized\n\nExclusion Criteria:\n\n* Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\\< 7.5 mg /day, or hydrocortisone =\\< 20 mg /day) is allowed\n* Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening\n* Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia\n* History of stroke or intracranial hemorrhage within 6 months prior to screening\n* History of other malignancies, except for malignancy surgically resected (or treated with other modalities) with curative intent, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; non-muscle invasive bladder cancer; malignancy treated with curative intent with no known active disease present for \\>= 3 years\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of adverse events","50% prostate specific antigen (PSA) level reduction"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":["car-t"],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes for Castration-Resistant Prostate Carcinoma","inPlainEnglish":"This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Castration-resistant prostate cancer continues to grow and spread despite the surgical removal of the testes or medical intervention to block androgen production.","whoItsFor":["Ages 18 Years to any","Men only","Assent, when appropriate, will be obtained per institutional guidelines","Agreement to allow the use of archival tissue from diagnostic tumor biopsies","If unavailable, exceptions may be granted with study principal investigator (PI) approval","Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Status (KPS) \\>= 70%","Documented castration resistant prostate cancer (mCRPC) (Note: castration will be defined by a testosterone \\< 50 ng/dL achieved by orchiectomy or luteinizing hormone-releasing hormone \\[LHRH\\] agonist/antagonist therapy)","Documented PSCA+ tumor expression as evaluated by the COH Pathology Clinical Trials Specimen Qualification Laboratory (CTSQL)","Progression of disease manifest by one of the following means during treatment with at least one advanced androgen targeted therapy (e.g., abiraterone or enzalutamide):"],"whoShouldSkip":["Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone =\\< 7.5 mg /day, or hydrocortisone =\\< 20 mg /day) is allowed","Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of screening","Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent","Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia","History of stroke or intracranial hemorrhage within 6 months prior to screening","Clinically significant uncontrolled illness"],"whatHappens":"If you join, the listed intervention(s) are Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes, Biopsy, or Biospecimen Collection. The registry lists allocation as randomized. This phase Ib trial tests the safety, side effects, and best dose of autologous anti-prostate stem cell antigen (PSCA)-chimeric antigen receptor (CAR)-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes (PSCA-CAR T cells), plus or minus radiation, in treating patients with castration-resistant prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 21 people at Duarte. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.312Z"},{"nctId":"NCT05809986","title":"Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study","officialTitle":"Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.","conditions":["Relapsing Multiple Sclerosis"],"keywords":["Relapsing Multiple Sclerosis","RMS","Ofatumumab","NIS","Portugal"],"interventions":[{"type":"OTHER","name":"Ofatumumab"}],"enrollment":174,"startDate":"2023-11-27","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nTo participate in the study, all the following inclusion criteria must be met:\n\n* Patients aged 18 years or older\n* Written informed consent obtained before participating in the study.\n* Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.\n* Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.\n* Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).\n* Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.\n\nExclusion Criteria:\n\nTo participate in the study, none of the following exclusion criteria must be met:\n\n* Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.","locations":[{"facility":"Novartis Investigative Site","city":"Amadora","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guimarães","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Leiria","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Matosinhos Municipality","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ponte de Lima","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Setúbal","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Proportion of patients demonstrating NEDA-3"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["amadora-portugal","guimar-es-portugal","leiria-portugal","lisbon-portugal","matosinhos-municipality-portugal","ponte-de-lima-portugal","porto-portugal","set-bal-portugal"],"enrichment":{"headline":"Not a traditional drug phase: Ofatumumab for Relapsing Multiple Sclerosis","inPlainEnglish":"This non-treatment study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.","whoItsFor":["Ages 18 Years to 99 Years","To participate in the study, all the following who can join must be met:","Patients aged 18 years or older","Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study","Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab","Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features)","Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion"],"whoShouldSkip":["To participate in the study, none of the following"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 174 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.271Z"},{"nctId":"NCT05815173","title":"Ladarixin With Sotorasib in Advanced NSCLC","officialTitle":"Phase I/II Study of Ladarixin and Sotorasib in Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).","conditions":["Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Ladarixin"}],"enrollment":40,"startDate":"2023-08-01","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.\n* Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous).\n* Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation.\n* Do not have an epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, rearranged during transfection (RET), ROS1 or other actionable molecular alterations that can be treated with FDA approved targeted agents.\n* Patients must have documentation of presence of KRASG12C mutation in tumor tissue.\n* Patients must have demonstrated progression of disease following treatment with anti-PD (L)-1 with or without platinum-based chemotherapy.\n* Participants must have at least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and have subsequently had documented progression, may be chosen as target lesions in the absence of measurable lesions that have not been irradiated.\n* Participants whose laboratory data at Screening meet the following criteria:\n\n  * Absolute neutrophil count ≥1.5 × 109/L\n  * Platelets ≥100 × 109/L\n  * Hemoglobin ≥8 g/dL without transfusion within 7 days\n  * Albumin ≥3 g/dL\n  * Lymphocyte count ≥0.5 × 109/L\n  * Serum bilirubin ≤1.5 × upper limit of normal (ULN), or ≤ 3.0 × ULN for subjects with Gilbert's Syndrome\n  * AST and ALT ≤ 2x upper limit of normal (ULN)\n  * International normalization ratio (INR) \\<1.5 if the patient is not on anticoagulants, or INR \\<3 after dose titration has been completed if the patient is on anticoagulants.\n  * Renal clearance as estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) Study equation ≥50 mL/min/1.73m2.\n* Persons of childbearing potential (POCBP, defined as a sexually mature person assigned female at birth) must have a negative serum pregnancy test prior to study entry. Women of non-childbearing potential will have had at least 12 continuous months of natural (spontaneous) amenorrhea, and an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms), or have had surgical bilateral oophorectomy, hysterectomy, or bilateral tubal ligation \\>6 weeks prior to Screening.\n* Persons assigned male at birth or persons assigned female at birth participants: Persons assigned male at birth participants with partners of childbearing potential and participants of childbearing potential are required to use 2 forms of acceptable contraception, including 1 barrier method, during their participation in the study and for 3 months following last dose. Persons assigned male at birth participants must also refrain from donating sperm during their participation in the study and for 12 months after the last dose of study medication.\n* Participants must be able to swallow and retain orally administered medication.\n\nExclusion Criteria:\n\n* History (≤1 years) or presence of hematological malignancies except stable CLL.\n* History (≤1 years) of other cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, ductal carcinoma in situ, prostatic intraepithelial neoplasia, superficial non-invasive bladder tumors, or curatively treated stage I non-melanoma skin cancer.\n* Known serious allergy to ladarixin, sotorasib, or excipients (e.g., microcrystalline cellulose).\n* History (≤6 months before the start of treatment with the study drugs) of severe autoimmune disease (including ≥ Grade 3 or recurrent Grade 2 immune-related AEs of prior immuno-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \\>10 mg/day or equivalent).\n* Brain or spinal metastases, except if treated by surgery or surgery plus radiotherapy or radiotherapy alone, with no clinical evidence of progression or hemorrhage for ≤7 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥7 days before the start of treatment with the study drugs.\n* History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2).\n* History of interstitial lung disease, radiation pneumonitis which required steroid treatment, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or organizing pneumonia.\n* Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics prior to first dose of study drug is required.\n* History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies.\n\n  \\-- Note: Testing for seropositive status during Screening will be at the discretion of the investigator in participants without previously reported results.\n* Has active hepatitis B, or hepatitis C infection.\n\n  * Note: Participants with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA polymerase chain reaction (PCR) that is below the limit of detection) are permitted. Participants with controlled infections must undergo periodic monitoring of hepatitis B virus DNA.\n  * Note: Participants who are hepatitis C virus antibody positive (HCV Ab+), who have controlled infection (undetectable HCV RNA by PCR either spontaneously or in response to a successful prior course of anti-HCV therapy) may be enrolled into the study. Participants with controlled infections must undergo periodic monitoring of HCV RNA per treating physician.\n* History (≤6 months before the start of treatment) of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator and sponsor, could affect the patient's participation in the study such as:\n\n  * Nonmalignant illnesses that are uncontrolled or whose control may be jeopardized by this study treatment.\n  * Nonmalignant decompensated liver disease.\n  * Significant gastrointestinal abnormalities or a chronic condition, including inability to swallow the formulated product, delayed gastric emptying, chronic active Crohn's disease that requires steroid therapy at any dose, refractory nausea and vomiting, and/or prior surgical procedures affecting absorption or requirement for intravenous alimentation.\n* History (≤6 months before the start of treatment with the study drugs) of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident.\n* Participants who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:\n\n  * Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible).\n  * Left ventricular ejection fraction (LVEF) \\<50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 6 months before the start of treatment with the study drugs and at screening.\n  * Resting bradycardia (\\<50 beats per minute) determined as the mean of 3 heart rate values from the screening triplicate 12-lead electrocardiograms (ECGs) obtained.\n  * Other clinically significant heart disease such as congestive heart failure New York Heart Association Class II-IV.\n* Participants with QT interval \\>470 msec at screening using Fridericia's formula (QTcF), determined as the mean of 3 QTcF values from the screening triplicate ECG.\n* Known history (≤6 months before the start of treatment with the study drugs) of significant inflammatory eye disease, central serous retinopathy, uveitis, or evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome).\n* Participants experiencing unresolved Grade \\>1 toxicity before the start of treatment with the study drug except for hair loss (alopecia), Grade 2 neuropathy is permitted if the investigator permits and written approval is granted by the medical monitor.\n* Participants who have neuromuscular disorders that are associated with elevated creatine kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis spinal muscular atrophy).\n* History (≤6 months before the start of treatment with the study drugs) of malignant biliary obstruction, except for patients with a functioning biliary stent.\n* Persons who are pregnant or breast-feeding.\n* Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain live vaccine are permitted.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Is at the time of signing informed consent, a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n* Known or suspected hypersensitivity to the active pharmaceutical ingredient, non-steroidal anti-inflammatory drugs or any excipient of the investigational medicinal products (e.g. lactose and croscarmellose) as well as patients with congenital lactase deficiency, galactosaemia or glucose-galactose intolerance.\n* History of treatment with KRAS inhibitors.\n* History of an allogeneic bone marrow or solid organ transplant.\n* Use of systemic anticancer agent (except for antiandrogen therapy for prostate cancer, therapy for bone metastases or cancer-related hypercalcemia) or investigational drug is prohibited ≤28 days for biologics and intravenous chemotherapy, or ≤14 days or 2 half-lives for small molecules, whichever is longer, prior to the first dose of ladarixin.\n* History of radiation therapy ≤7 days prior to the first dose of ladarixin.\n* Use of drugs known to be moderate or strong CYP3A4 inhibitors or inducers or sensitive CYP3A4 substrates with a narrow therapeutic index is prohibited ≤14 days before the start of treatment with the study drug until the end-of-treatment visit. Some of these medications may be allowed at the investigator's discretion after written approval by the medical monitor.\n* Treatment with drugs metabolized by CYP2C9 with a narrow therapeutic index \\[i.e., phenytoin, warfarin, and high dose of amitriptyline (\\>50 mg/day)\\].\n* Use of herbal drugs and supplements known to be moderate or strong CYP3A4 inhibitors or inducers or sensitive CYP3A4 substrates with a narrow therapeutic index is prohibited ≤14 days before the start of treatment with the study drug until the end- of-treatment visit. These herbal medications include but are not limited to: St. John's wort, cannabis (including \"medical marijuana\"), kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.\n* History (≤28 days before the start of treatment with the study drugs) of major surgery or trauma or likelihood to require surgery at any time until the permanent discontinuation of treatment (the significance will be determined by the investigator after consultation with the medical monitor).\n* Participants who start erythropoietin or G-CSF, pegfilgrastim, or filgrastim ≤2 weeks before start of treatment with the study drug.\n* History (≤1 weeks before the first dose of ladarixin) of transfusion of whole blood, red blood cells or platelet packets.\n* History (≤2 weeks before the start of treatment with the study drugs) of medications with known risk of Torsades de Pointes (cardiac arrhythmia due to drug-induced QTc prolongation).\n* Use of H2-receptor antagonists, proton pump inhibitors, and/or intraluminal antacids within 3 days or 5 half-lives (whichever is longer) prior to starting ladarixin.","locations":[{"facility":"NYU Langone Health","city":"Garden City","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New Hyde Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Salman Punekar, MD","phone":"212 731 6228","email":"Salman.punekar@nyulangone.org"}],"primaryOutcomes":["Incidence of Dose-Limiting Toxicities (DLTs) during 1st Treatment Cycle among Phase I Participants","Progression Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["garden-city-new-york","mineola-new-york","new-hyde-park-new-york","new-york-new-york"],"enrichment":{"headline":"Phase 1: testing Sotorasib for Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation","inPlainEnglish":"This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).","whoItsFor":["Ages 18 Years to 100 Years","Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1","Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous)","Patients with metastatic or locally advanced NSCLC who are not candidates for curative surgery or curative radiation","Do not have an epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) translocation, rearranged during transfection (RET), ROS1 or other actionable molecular alterations that can be treated with FDA approved targeted agents","Patients must have documentation of presence of KRASG12C mutation in tumor tissue","Patients must have demonstrated progression of disease following treatment with anti-PD (L)-1 with or without platinum-based chemotherapy","Participants whose laboratory data at Screening meet the following criteria:"],"whoShouldSkip":["History (≤1 years) or presence of hematological malignancies except stable CLL","Known serious allergy to ladarixin, sotorasib, or excipients (e.g., microcrystalline cellulose)","History (≤6 months before the start of treatment with the study drugs) of pericarditis (any grade) or pericardial effusion (Grade ≥2)","History of interstitial lung disease, radiation pneumonitis which required steroid treatment, idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic pneumonitis, or organizing pneumonia","Active infection requiring systemic treatment at the start of treatment in this trial. A washout period of 7 days after the last dose of antibiotics prior to first dose of study drug is required","History of seropositive status for human immunodeficiency virus (HIV) at any time before the start of treatment as determined by presence of anti-HIV-1 or anti-HIV-2 antibodies","\\-- Note: Testing for seropositive status during Screening will be at the discretion of the investigator in participants without previously reported results"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib, or Ladarixin. The registry lists allocation as na. This is a phase I/II, open-label, study of twice-daily oral ladarixin with sotorasib in participants with advanced KRASG12C mutant non-small cell lung cancer (NSCLC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 40 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.973Z"},{"nctId":"NCT05819853","title":"Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome","officialTitle":"Role of Semaglutide in Restoring Ovulation in Youth and Adults With Polycystic Ovary Syndrome","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.","conditions":["PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries","Obese"],"keywords":["PCOS","semaglutide"],"interventions":[{"type":"DRUG","name":"Semaglutide Injectable Product (Wegovy and/or Ozempic)"}],"enrollment":80,"startDate":"2023-11-03","completionDate":"2028-02-01","sex":"FEMALE","minAge":"12 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Female\n2. Ages 12-35 years\n3. Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week.\n4. Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines\n5. Initial BMI based on age and weight:\n\n   1. If \\<18 years, initial BMI percentile ≥95\n   2. If 18-35 years, initial BMI ≥30 kg/m2 OR initial BMI ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia\n   3. Must be weight stable within ±5kg in the 3 months prior to enrollment\n6. Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \\>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia\n7. Participants cannot be on hormonal contraception, so participants should remain abstinent or use reliable non-hormonal contraception (e.g., copper IUD) for the entire study period. For participants who receive semaglutide, they should avoid pregnancy for at least 2 months after stopping medication to avoid fetal exposure to the medication.\n8. For participants in the metformin + semaglutide group, participants must have been stable on ≥ 1500 mg of metformin a day for at least 3 months by time of screening\n\nExclusion Criteria:\n\n1. Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label\n2. Use of medications known to affect insulin sensitivity: metformin (cannot have been used in the 3 months prior to screening for the untreated arm of the study), chronic oral steroids, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications, estrogen-containing hormonal contraception (cannot have been used in the 6 months prior to screening), progesterone-containing hormonal contraception (cannot have been used in the 3 months prior to screening). Dermal patch or vaginal ring contraception methods. Weight loss medications or stimulants. Use of other products containing other GLP-1 agonists.\n3. Weight loss medications in the last 6 months\n4. Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study.\n5. Severe illness requiring hospitalization within 60 days.\n6. Diabetes, defined as Hemoglobin A1C ≥6.5%\n7. Anemia, defined as Hemoglobin \\< 12 mg/dL\n8. Diagnosed major psychiatric or developmental disorder limiting informed consent.\n\n10\\) Known liver disease other than NAFLD, or AST or ALT \\>125 IU/L. 11) Personal history of pancreatitis 12) Known renal disease of any severity or an eGFR at screening of \\<45ml/min/1.73m2 13) History of severe GI disease (e.g., gastroparesis) 14) History of gallstones 15) Untreated thyroid disease 16) History of hypersensitivity to semaglutide 17) Other causes of hyperandrogenism (example: tumor, CAH) or amenorrhea (untreated thyroid disease, tumor, primary ovarian failure, prolactinoma).\n\n18\\) Active symptoms or undergoing treatment for anorexia nervosa or binging/purging disorder 19) Desiring pregnancy in the next 12-18 months. 20) Bariatric surgery 21) Use of THC (smoking or edible) more than 3 days a week 22) Alcohol use-drinking more than 2 drinks, more than 3 days a week 23) Any potential participants who cannot/will not commit to abstinence, use of a copper intrauterine device (IUD), or use of double barrier forms of contraception.","locations":[{"facility":"University of Colorado Anschutz/Children's Hospital Colorado Aurora","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yesenia Garcia-Reyes, MS","phone":"720-777-6984","email":"PCOSresearch@cuanschutz.edu"}],"primaryOutcomes":["Change in ovulation frequency before and after semaglutide in females with PCOS"],"hasResults":false,"conditionSlugs":["obesity","pcos"],"drugSlugs":["semaglutide"],"locationSlugs":["aurora-colorado"],"enrichment":{"headline":"Phase 3: testing Semaglutide Injectable Product (Wegovy and/or Ozempic) for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries","inPlainEnglish":"Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.","whoItsFor":["Ages 12 Years to 35 Years","Women only","Sedentary- less than 2 hours of moderate (jogging, swimming etc.) exercise a week","Oligomenorrhea, on or off metformin, as defined per age category in the most recent 2018 PCOS international guidelines","Initial body-mass index (BMI) based on age and weight:","If \\<18 years, initial body-mass index (BMI) percentile ≥95","If 18-35 years, initial body-mass index (BMI) ≥30 kg/m2 OR initial body-mass index (BMI) ≥27 kg/m2 with at least one weight-related comorbid condition, e.g., hypertension or dyslipidemia","Must be weight stable within ±5kg in the 3 months prior to enrollment","Diagnosed with PCOS per the most stringent NIH criteria with adaptation for adolescents (oligomenorrhea \\>24 months post-menarche or primary amenorrhea after age 15 years and clinical/ biochemical hypertestosteronemia"],"whoShouldSkip":["Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2). Family history of medullary thyroid cancer or thyroid nodule palpated by endocrinologist at screening. - Per approved drug label","Weight loss medications in the last 6 months","Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study","Severe illness requiring hospitalization within 60 days","Diabetes, defined as Hemoglobin A1C ≥6.5%","Anemia, defined as Hemoglobin \\< 12 mg/dL"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide Injectable Product (Wegovy and/or Ozempic). The registry lists allocation as randomized. Girls and women 12-35 years old with obesity and polycystic ovarian syndrome who are on or off metformin, will receive a glucagon like peptide-1 receptor agonist intervention for 10 months to induce metabolic changes, weight loss and improve reproductive abnormalities.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 80 people at Aurora. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.791Z"},{"nctId":"NCT05828446","title":"Improving Hepatocellular Carcinoma Screening","officialTitle":"Prospective Comparison of Diagnostic Performance and Cost-effectiveness of US and Abbreviated MRI for Hepatocellular Carcinoma Screening","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Naik Vietti Violi","sponsorClass":"OTHER","summary":"This is a monocentric, single blind, interventional, single arm study. It is designed to compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used in clinical routine vs. abbreviated magnetic resonance imaging (AMRI). The hypothesis is that dynamic AMRI with extracellular contrast agent injection has a higher patient-level detection rate of HCC than screening US and non-contrast AMRI.\n\nInterested and eligible patients will be enrolled and undergo HCC screening rounds including US +/- contrast-enhanced US (clinical routine) and screening MRI within the same week bi-annually.","conditions":["Magnetic Resonance Imaging","Hepatocellular Carcinoma","Screening","Contrast-enhanced US"],"keywords":[],"interventions":[{"type":"DEVICE","name":"MRI"}],"enrollment":330,"startDate":"2023-04-01","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* All adult patients with chronic liver disease and indication for HCC screening according to the European Association for the Study of the Liver recommendations.\n* Informed Consent signed by the subject\n\nExclusion Criteria:\n\n* History of HCC\n* History of other malignancy\n* Prior liver nodule categorized as LI-RAD 4, 5 or M\n* History of liver transplantation\n* Pregnancy\n* MRI or MRI contrast agent precaution\n* Any other condition making the patient unsuitable for the study\n* Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study","locations":[{"facility":"Lausanne University Hospital","city":"Lausanne","state":"Canton of Vaud","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naik Vietti Violi, MD","phone":"+41213144556","email":"naik.vietti-violi@chuv.ch"},{"name":"Clarisse Dromain, MD","phone":"+41213144556","email":"Clarisse.dromain@chuv.ch"}],"primaryOutcomes":["To compare the diagnostic performance of US+/- CEUS and AMRI for HCC detection in an at-risk population"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["lausanne-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: MRI for Magnetic Resonance Imaging","inPlainEnglish":"This is a monocentric, single blind, treatment, single arm study. It is designed to compare the rates of detection of hepatocellular carcinoma (HCC) by ultrasound (US) used in clinical routine vs.","whoItsFor":["Ages 18 Years to any","All adult patients with chronic liver disease and indication for HCC screening according to the European Association for the Study of the Liver recommendations"],"whoShouldSkip":["History of other malignancy","Prior liver nodule categorized as LI-RAD 4, 5 or M","History of liver transplantation","MRI or MRI contrast agent precaution","Any other condition making the patient unsuitable for the study","Patient's refusal of transmission of relevant medical conditions found on the medical examinations performed during the study"],"whatHappens":"If you join, the listed intervention(s) are MRI. The registry lists allocation as na. This is a monocentric, single blind, treatment, single arm study.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 330 people at Lausanne. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.626Z"},{"nctId":"NCT05830058","title":"Positron Emission Tomography (PET) Guided Stereotactic Body Radiation Therapy for the Treatment of Oligoprogressive Non-small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma","officialTitle":"Phase II Randomized Controlled Trial of Biologically Guided Stereotactic Body Radiation Therapy in Oligoprogressive Non-Small Cell Lung Cancer, Melanoma, and Renal Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.","conditions":["Lung Non-Small Cell Carcinoma","Malignant Solid Neoplasm","Melanoma","Renal Cell Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy"}],"enrollment":32,"startDate":"2023-11-29","completionDate":"2028-02-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) =\\< 2\n* Histologically or cytologically confirmed NSCLC with 1-5 sites of disease progression while on or following systemic therapy with a checkpoint inhibitor with or without chemotherapy for at least 3 months with radiographic evidence of progression based on Response Evaluation Criteria in Solid Tumors (RECIST) or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST)\n* Lesion(s) must all be amenable to SBRT which will be determined by the radiation oncologists. Active lesions should be a minimum size of \\>= 1 cm\n* Primary tumor should be controlled for \\> 3 months in the metachronous setting; for synchronouos progression of the primary and oligoprogressive site(s), the primary should be treated with curative/local control intent\n* Patients eligible for the study must have at least one lesion for which the planned radiation dose achieves a biologic effective dose (BED) \\< 100 (alpha/beta = 10) due to organs at risk and dose constraints\n* If the clinical scenario deem that other forms of local therapy may be more suitable for the metastatic disease, such as surgical resection and interventional radiology-guided ablation, patients would be able to undergo other forms of local therapy after discussion with the study PI but at least one lesion must be treated with SBRT in this scenario\n* Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and are not considered as a site of oligoprogression\n* Life expectancy \\>= 3 months in the opinion of the treating investigators\n\nExclusion Criteria:\n\n* Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements\n* Those not eligible for SBRT after review by a radiation oncologist\n* Unable to undergo a Pet/CT or do not have Pet active disease\n* Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Feasibility and safety of positron emission tomography (PET) adaptive stereotactic body radiation therapy (SBRT)"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","kidney-cancer","als"],"drugSlugs":[],"locationSlugs":["duarte-california","irvine-california"],"enrichment":{"headline":"Phase 2: Biospecimen Collection for Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision.","whoItsFor":["Ages 18 Years to any","Assent, when appropriate, will be obtained per institutional guidelines","Agreement to allow the use of archival tissue from diagnostic tumor biopsies","If unavailable, exceptions may be granted with study principal investigator (PI) approval","Eastern Cooperative Oncology Group (ECOG) =\\< 2","Lesion(s) must all be amenable to SBRT which will be determined by the radiation oncologists. Active lesions should be a minimum size of \\>= 1 cm","Primary tumor should be controlled for \\> 3 months in the metachronous setting; for synchronouos progression of the primary and oligoprogressive site(s), the primary should be treated with curative/local control intent","Patients eligible for the study must have at least one lesion for which the planned radiation dose achieves a biologic effective dose (BED) \\< 100 (alpha/beta = 10) due to organs at risk and dose constraints"],"whoShouldSkip":["Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements","Those not eligible for SBRT after review by a radiation oncologist","Unable to undergo a Pet/CT or do not have Pet active disease","Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Positron Emission Tomography. The registry lists allocation as randomized. This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.809Z"},{"nctId":"NCT05832229","title":"Liver Cirrhosis Network Rosuvastatin Efficacy and Safety for Cirrhosis in the United States","officialTitle":"Liver Cirrhosis Network (LCN) Rosuvastatin Efficacy and Safety for Cirrhosis in the United States (RESCU): A Double-Blind Randomized, Placebo-Controlled Phase 2 Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"This is a double-blind, phase 2 study to evaluate safety and efficacy of rosuvastatin in comparison to placebo after 2 years in patients with compensated cirrhosis.","conditions":["Cirrhosis","Cirrhosis, Liver","Cirrhosis Early","Cirrhosis Due to Hepatitis B","Cirrhosis Advanced","Cirrhosis Infectious","Cirrhosis Alcoholic","Cirrhosis Due to Hepatitis C"],"keywords":["Cirrhosis","Liver","Nonalcoholic Fatty Liver Disease"],"interventions":[{"type":"DRUG","name":"Rosuvastatin"}],"enrollment":260,"startDate":"2023-12-07","completionDate":"2029-08-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Age 18-75 years\n2. Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)\n3. Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following:\n\n   a. At least one liver biopsy within 5 years prior to consent showing either: Metavir stage 4 fibrosis; Ishak Stage 5-6 fibrosis, OR b. At least 2 of the following: i. Evidence on imaging: Nodular liver with either splenomegaly or recanalized umbilical vein within the past 48 weeks ii. Liver stiffness: VCTE within 48 weeks prior to consent or during Screening ≥15.0 kPa or MRE within 48 weeks prior to consent or during Screening ≥5 kPa iii. Evidence of varices demonstrated on imaging or endoscopy within 3 years prior to consent or during Screening iv. Either: FIB-4\\>2.67 or platelets \\<150/mL within 6 months prior to consent or during Screening\n4. Two measures of VCTE: one at screening and one at the open-label dispense study visit, meeting the following criteria:\n\n   1. The first measure must be ≥ 15.0 kPa.\n   2. The two measures must be at least 2 hours apart and no more than 60 days apart from one another.\n   3. The mean of two measurements must be ≥ 15.0 kPa.\n   4. Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa\n5. Compensated defined by:\n\n   1. Absence of ascites/hydrothorax, hepatic encephalopathy or variceal bleeding currently or in the last 48 weeks, as determined clinically by investigator.\n   2. If prior history of decompensation, must be without current symptoms of decompensation and no longer requiring treatment of complications for the last 48 weeks, including the use of diuretics for the treatment of ascites, and/or rifaximin or lactulose for the treatment of hepatic encephalopathy. Use of non-selective beta blockers will be allowed.\n   3. Child-Pugh score \\<8\n6. Provision of written informed consent. Exclusion Criteria\n\n<!-- -->\n\n1. Currently on a statin or any statin exposure within 24 weeks prior to consent.\n2. Known indication for statin therapy, defined as:\n\n   1. Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR\n   2. Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR\n   3. Fasting LDL-C ≥ 190 mg/dL\n3. Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening.\n4. Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening.\n5. Patients with limitations in attending study visits.\n6. Prisoners.\n7. Known prior or current hepatocellular carcinoma (HCC) or cholangiocarcinoma.\n8. Known transjugular intrahepatic portosystemic shunt (TIPS), balloon retrograde transvenous obliteration (BRTO) or porto-systemic shunt surgery regardless of time of occurrence.\n9. Current (in past 24 weeks prior to consenting) use of medications known to cause hepatic fibrogenesis or confound endpoint assessment, defined as:\n\n   1. amiodarone\n   2. methotrexate\n   3. warfarin\n10. Current (in past 24 weeks prior to consenting) use of medications which may increase risk for rosuvastatin-related myositis or DILI, defined as:\n\n    1. fenofibrate\n    2. erythromycin\n    3. gemfibrozil\n    4. niacin (500 mg or more)\n    5. HIV protease inhibitors (darunivar, indinavir, nelfinavir, amprenavir)\n    6. colchicine\n    7. cyclosporin\n    8. Additional medications that will be excluded:\n\n       atazanavir/ritonavir capmatinib darolutamide dasabuvir/ombitasvir/paritaprevir/ritonavir ledipasvir/sofosbuvir elbasvir/grazoprevir erythromycin lopinavir/ritonavir regorafenib ritonavir, in any combination simeprevir sofbuvir/velpatasvir/voxilaprevir sofosbuvir/velpatasvir tafamidis tamoxifen teriflunomide\n\n       \\*If exposure was for 7 or less days for one of these medications can consider enrollment after 28 days from final dose.\n11. Presence of portal or hepatic vein thrombosis\n12. Diagnosis of untreated hypothyroidism or on unstable treatment regimen for hypothyroidism\n13. Receiving an elemental diet or parenteral nutrition\n14. Chronic pancreatitis or pancreatic insufficiency\n15. Etiology of cirrhosis other than ALD, NAFLD, or viral hepatitis (excluded diagnoses include cryptogenic immune-mediated such as AIH, PSC and PBC, cardiac cirrhosis or Fontan-associated liver disease, A1AT, Wilson's disease, etc.)\n16. Conditions which may confound study outcome:\n\n    a. Unstable or active inflammatory bowel disease b. Active infection c. Any malignant disease (other than squamous or basal cell carcinoma of the skin) within previous 3 years d. Prior solid organ or hematopoietic cell transplant e. Bariatric surgery in the last 24 weeks prior to consent or planned bariatric surgery within the next 96 weeks f. Current liver-unrelated end-stage organ failures such as end-stage renal disease on dialysis, stage 3-4 congestive heart failure (CHF), current chronic obstructive pulmonary disease (COPD) on home oxygen.\n17. Known current medical or psychiatric conditions which, in the opinion of the investigator, would make the participant unsuitable for the study for safety reasons or interfere with or prevent adherence to the protocol.\n18. The following laboratory abnormalities within 90 days of screening:\n\n    a. Hemoglobin \\<10 g/dL b. Albumin \\<3.0 g/dL c. Prolonged international normalized ratio (INR) \\>1.5 d. Total bilirubin ≥ 2.0 mg/dl (unless due to Gilbert's syndrome or hemolysis as denoted by normal direct bilirubin fraction) e. Direct bilirubin ≥ 0.9 f. Uncontrolled diabetes (HbA1c ≥ 9.5%) within past 90 days.\n19. Kidney function abnormalities including:\n\n    1. Dialysis\n    2. Baseline eGFR \\< 30 cc/min with CKD-Epi equation\n    3. Known nephrotic proteinuria, defined as 3g or greater of protein in 24-hour urine collection\n20. Recent (within 48 weeks) or present hepatic decompensation with ascites/hydrothorax, hepatic encephalopathy or variceal bleeding\n21. Untreated chronic hepatitis B or C infection\n\n    1. HCV eligible for enrollment if HCV RNA negative at baseline or documentation of prior SVR12\n    2. HBV eligible if an HBV DNA \\<100 IU/mL within the last 48 weeks and on treatment\n22. Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 200 U/L within the past 24 weeks or alkaline phosphatase (ALP) ≥ 300.\n23. Documented history of intolerance to statins\n24. Serious comorbid medical disease which in the investigator's opinion renders a life-expectancy less than 96 weeks\n25. Active illicit substance use (other than THC), including inhaled or injected drugs, in the 24 weeks prior to screening\n26. Pregnancy, planned pregnancy or breastfeeding\n27. Current participation in active medication treatment trials (within 24 weeks prior to randomization) or planned participation in active medication treatment trials simultaneous to participation in present trial.\n28. Significant existing muscle pain or tenderness or prior history of myasthenia gravis as determined by a site physician.\n29. Failure or inability to provide informed consent.\n30. East Asian Descent within one degree of relatedness (e.g., if the participant's parents are of East Asian descent)","locations":[{"facility":"University of California San Diego NAFLD Research Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medical Center of USC","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LAC + USC Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF/Zuckerberg San Francisco General Hospital and Trauma Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Health System","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Presbyterian/Weill Cornell","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Iriving School of Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Liver Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Crystal Santillanes, MS","phone":"312-503-5536","email":"lcn@northwestern.edu"},{"name":"Mary Beth Tull, MBA, CCRP","phone":"312-503-4746","email":"mary.tull@northwestern.edu"}],"primaryOutcomes":["Mean change in liver stiffness"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["la-jolla-california","los-angeles-california","san-francisco-california","miami-florida","ann-arbor-michigan","rochester-minnesota","new-york-new-york","durham-north-carolina","cleveland-ohio","richmond-virginia"],"enrichment":{"headline":"Phase 2: testing Rosuvastatin for Cirrhosis","inPlainEnglish":"This is a neither you nor the study doctors know who gets the real treatment, phase 2 study to evaluate safety and how well it works of rosuvastatin in comparison to dummy treatment (placebo) after 2 years in patients with compensated cirrhosis.","whoItsFor":["Ages 18 Years to 75 Years","Cirrhosis due to NAFLD, ALD, or chronic viral hepatitis (treated HBV or HCV)","Clinical diagnosis of cirrhosis as defined by investigator confirmation and the following:","Two measures of VCTE: one at screening and one at the open-label dispense study visit, meeting the following criteria:","The first measure must be ≥ 15.0 kPa","The two measures must be at least 2 hours apart and no more than 60 days apart from one another","The mean of two measurements must be ≥ 15.0 kPa","Additionally, both screening and open-label dispense liver stiffness measures must be ≤50 kPa"],"whoShouldSkip":["Currently on a statin or any statin exposure within 24 weeks prior to consent","Known indication for statin therapy, defined as:","Prior peripheral vascular, cardiovascular or cerebrovascular event for which statins are indicated for secondary prevention, OR","Documented familial hypercholesterolemia, heterozygous familial hypercholesterolemia, OR","Fasting LDL-C ≥ 190 mg/dL","Myocardial infarction, Unstable angina, transient ischemic events, or stroke within 24 weeks of screening","Alcohol Use Disorder Identification Test (AUDIT) total score of ≥8 at screening"],"whatHappens":"If you join, the listed intervention(s) are Rosuvastatin. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, phase 2 study to evaluate safety and how well it works of rosuvastatin in comparison to dummy treatment (placebo) after 2 years in patients with compensated cirrhosis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 260 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.165Z"},{"nctId":"NCT05834855","title":"Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS","officialTitle":"Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Amsterdam UMC, location VUmc","sponsorClass":"OTHER","summary":"Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS. An advantage of rituximab is a considerably lower price. Therefore we will start a study aimed at demonstrating non-inferiority of rituximab compared to ocrelizumab in RMS. If non-inferiority of rituximab can be shown, important reductions in the cost of treatment of RMS will be possible, without loss of efficacy.\n\nObjective: Evaluating the efficacy and safety of ritixumab compared to ocrelizumab in the treatmens of RMS.\n\nStudy design: Randomized double blind multi-centre non-inferiority study of rituximab compared to ocrelizumab in 200 patients with RMS. The trial duration will be 30 months\n\nStudy population: The study population consists of 200 adult RMS patiens with an indication to start anti-CD20 monoclonal antibody treatment.\n\nIntervention: Patients will be randomized 1:1 into the standard group (ocrelizumab treatment) or the experimental group (rituximab treatment).\n\nMain study parameters: To conclude non-inferiority of rituximab there will be one primary endpoint: the proportion of patients free of inflammatory disease activity (defined as: new or enlarged T2 lesions) between week 24 (M6) and week 96 (M24) of treatment in each arm. Secondary trial endpoints are presence and number of clinical relapses,T2 and contrast enhancing lesion volumes, brain volume and brain volume changes, disease progression (defined as clinically relevant change on any of the measures: EDSS, T25FW, 9HPT, SDMT), biochemical parameters such as lipidomics and neurofilament light (NfL), immunological parameters, safety as measured by the number of (serious) adverse events ((S)AE), quality of life (EQ-5D-L) and treatment satisfaction (TSQM) and patient reported measures of MS impact (MSIS-29) and well-being (questionnaire on physical complaints)\n\nNature and extent of the burden and risk: Patients included in this study will be treated and monitored by MRI, clinical tests and laboratory tests according to existing protocols and will not be exposed to extra or unknown risks. They will have extra annual questionnaires and larger blood samples at some time points. There is extensive experience with both rituximab and ocrelizumab as efficacious and safe treatments of RMS.","conditions":["Multiple Sclerosis","Multiple Sclerosis, Relapsing-Remitting","Demyelinating Autoimmune Diseases, CNS","Autoimmune Diseases of the Nervous System","Nervous System Diseases","Demyelinating Diseases"],"keywords":["ocrelizumab","rituximab","non-inferiority"],"interventions":[{"type":"DRUG","name":"Rituximab"}],"enrollment":200,"startDate":"2023-04","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Men and women aged 18 years and older\n2. A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria\n3. Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS\n4. Able to understand written and spoken Dutch or English\n5. Capable of giving signed informed consent including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n6. Screening EDSS score ≤ 6.5 .\n\nExclusion Criteria:\n\nMedical Conditions\n\n1. A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids.\n2. A diagnosis of primary progressive MS according to the diagnostic criteria.\n3. A diagnosis of not-active secondary progressive MS.\n4. Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening visit.\n5. A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis\n6. Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.\n7. Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC\n8. Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC.\n9. WBC \\< 1.5 x 109/L if not caused by a reversible effect of documented ongoing medication. If caused by a reversible effect of documented ongoing medication the WBC count must be \\> 1,5 x 109/L before start of study treatment.\n10. Platelet (thrombocyte) count \\< 100 x 109/L\n11. ALAT and/or ASAT more than 2 times the upper normal reference limit (ULN)\n12. Serum creatinine \\> 200 μmol/L\n13. Serum bilirubin \\> ULN\n14. Serum IgG \\< LLN\n15. Pregnant or breast-feeding women\n16. Women of childbearing potential (WOCBP) not able or willing to use highly effective methods of birth control per ICH M3 (R2) that result in failure rate of ≤ 1% per year when used consistently and correctly for the duration of the study OR until 3 months after last dose administered.\n17. History of serious or life-threatening infusion reaction to OCR or RTX\n18. Treatment with glucocorticoids or ACTH within one month prior to start of study treatment\n\n    Prior/Concomitant Therapy\n19. Previous use of second line MS-therapies cladribine, RTX, alemtuzumab, OCR, ofatumumab, hematopoietic stem cell therapy (HSCT) or other immunosuppression therapies with long lasting effects. Mitoxantrone is allowed if used \\> 1 year before enrolment. If any of these medications have been used for indications other than MS, patients can be included if the medications have not been used the year before enrolment. Previous treatment with natalizumab is allowed if the reason to switch was disease activity (so not allowed in for example cases that switch from natalizumab to anti-CD20 therapy because of JCV positivity).\n20. Concomitant use of systemic immunosuppressive medication (except corticosteroids for symptomatic treatment of relapses).\n\n    Prior/Concurrent Clinical Study Experience\n21. Currently enrolled in another investigational device or drug study, or less than 30 days since ending of another investigational device or drug study (s), or receiving other investigational treatment(s). Patients participating in a purely observational studies will be allowed to participate.\n\n    Lifestyle\n22. Current alcohol or drug dependencies.\n\n    Diagnostic assessments\n23. Presence of metallic objects implanted in the body, that would preclude the ability of the patient to safely have MRI exams.\n24. Not willing to undergo MRI scans with i.v. gadolinium injections","locations":[{"facility":"Amsterdam UMC, location VUmc","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Schoof, Msc","phone":"650087853","email":"l.g.schoof@amsterdamumc.nl"},{"name":"Eva Strijbis, Dr.","phone":"204442182","email":"e.strijbis@amsterdamumc.nl"}],"primaryOutcomes":["Proportion of patients free of inflammatory disease activity"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["amsterdam-netherlands"],"enrichment":{"headline":"Phase 3: testing Rituximab for Multiple Sclerosis","inPlainEnglish":"Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS). Phase II studies and data from large patient cohorts indicate that rituximab, another anti-CD20 monoclonal antibody, is probably equally effective and safe as ocrelizumab in the treatment of RMS.","whoItsFor":["Ages 18 Years to any","Men and women aged 18 years and older","A diagnosis of relapsing MS according to the 2017 revised diagnostic criteria","Indication to start treatment with anti-CD20 therapy according to the treating neurologist and the relevant label in the Netherlands for treatment of relapsing MS","Screening EDSS score ≤ 6.5"],"whoShouldSkip":["A known allergy or other intolerability to RTX, OCR, gadolinium-based MRI contrast agents, or corticosteroids","A diagnosis of primary progressive MS according to the diagnostic criteria","A diagnosis of not-active secondary progressive MS","Chronic infectious diseases such as tuberculosis, VZV, hepatitis virus or HIV, as well as hepatitis B surface antigen positivity and/or hepatitis C PCR positivity verified at screening visit","A history of proven inflammatory bowel disease such as M. Crohn or ulcerative colitis","Cardiac disease that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC","Active malignancy or prior history of malignancy that makes treatment with OCR or RTX contra-indicated as stated by the most recent SmPC"],"whatHappens":"If you join, the listed intervention(s) are Rituximab. The registry lists allocation as randomized. Rationale: Ocrelizumab is widely and effectively used to treat relapsing multiple sclerosis (RMS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 200 people at Amsterdam. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.997Z"},{"nctId":"NCT05836987","title":"The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","officialTitle":"REACT-AF: Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"REACT-AF is a multicenter prospective, randomized, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.","conditions":["Atrial Fibrillation"],"keywords":["Atrial Fibrillation","Anticoagulation","AF-sensing Smart Watch","Ischemic Stroke","Systemic Embolism"],"interventions":[{"type":"DEVICE","name":"AFSW Guided DOAC"},{"type":"DRUG","name":"Continuous DOAC therapy"}],"enrollment":5350,"startDate":"2023-07-13","completionDate":"2029-07-31","sex":"ALL","minAge":"22 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 22-85 years of age.\n2. English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.\n3. History of non-permanent atrial fibrillation.\n4. CHA2DS2-VASC score of 1-5 for men and 2-5 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF) patients. The acronym CHA2DS2-VASc stands for congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female). Congestive heart failure defined as: The presence of signs and symptoms of either right (elevated central venous pressure, hepatomegaly, dependent edema) or left ventricular failure (exertional dyspnea, cough, fatigue, orthopnea, paroxysmal nocturnal dyspnea, cardiac enlargement, rales, gallop rhythm, pulmonary venous congestion) or both, confirmed by non-invasive or invasive measurements demonstrating objective evidence of cardiac dysfunction and/or ejection fraction \\< 40%.\n5. The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.\n6. Willing and able to comply with the protocol, including:\n\n   * Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan\n   * Be willing to wear the smart watch for the suggested minimum of 14 hours a day\n   * Expected to be within cellular service range at least 80% of the time\n7. Willing and able to discontinue DOAC\n8. The participant is willing and able to provide informed consent.\n\nExclusion Criteria:\n\n1. Valvular or permanent atrial fibrillation.\n2. Current treatment with warfarin and unwilling or unable to take a DOAC.\n3. The participant is a woman who is pregnant or nursing.\n4. The participant is being treated with chronic daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration. Use of low-dose aspirin is permitted.\n5. Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor. Insertable cardiac monitors are permitted unless they are being used to guide anticoagulation treatment.\n6. Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.\n7. Any documented single AF episode lasting ≥ 1 hour on a cardiac monitor performed within 90 days prior to randomization.\n8. Ablation for AF within the last 2 months.\n9. Prior or anticipated left atrial appendage occlusion or ligation.\n10. Mechanical prosthetic valve(s) or severe valve disease.\n11. Hypertrophic cardiomyopathy.\n12. Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects, prosthetic heart valve).\n13. Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \\> 75%) based on the investigator's discretion.\n14. The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial. Co-enrollment in concurrent trials is only allowed with documented pre-approval from the study manager; there is no concern that co-enrollment could confound the results of this trial.\n15. The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.\n16. The participant has a tremor on their ipsilateral side that the AFSW may be worn.\n17. Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).\n18. Known hypersensitivity or contraindication to direct oral anticoagulants.\n19. Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.\n20. Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.\n21. \\> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.\n22. History of ECG-documented, sustained atrial flutter that has not been treated with ablation (participants with atrial flutter who have been ablated are eligible for enrollment)\n23. Stage 4 or 5 chronic kidney disease.\n24. Conditions associated with an increased risk of bleeding:\n\n    * Major surgery in the previous month\n    * Planned surgery or intervention in the next three months that would require cessation of anticoagulation \\> 2 weeks.\n    * History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding\n    * Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)\n    * Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days\n    * Hemorrhagic disorder or bleeding diathesis\n    * Need for anticoagulant treatment for disorders other than AF\n    * Uncontrolled hypertension (Systolic Blood Pressure \\>180 mmHg and/or Diastolic Blood Pressure \\>100 mmHg)","locations":[{"facility":"Banner University","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California - Keck School of Medicine","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles (UCLA Health)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Davis Health","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scripps Health","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Denver Cardiology Associates, P.C.","city":"Littleton","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Faculty Associates George Washington University","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"BayCare Health Systems","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami - Leonard S. Miller SOM","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarasota Memorial Health Care System","city":"Sarasota","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Florida","city":"Stuart","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Baycare Health Systems Clearwater","city":"Winter Haven","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georgia Arrhythmia Consultants and Research Institute","city":"Warner Robins","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loyola University Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alexian Brothers Health System","city":"Elk Grove Village","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University HealthSystem","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Cardiovascular Institute","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension St. Vincent","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maine Medical Partners MaineHealth Cardiology","city":"Scarborough","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMass Chan Medical School","city":"Worcester","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health (Former Spectrum Health)","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Grand Rapids/Mercy Health","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"William Beaumont Hospital","city":"Royal Oak","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Michigan Heart - Ann Arbor","city":"Ypsilanti","state":"Michigan","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Heart and Vascular Institute of Hunterdon","city":"Flemington","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Meridian Health","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers, the State University of New Jersey","city":"Piscataway","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Valley Hospital, Inc.","city":"Ridgewood","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico Health Sciences Center","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Healthcare Services","city":"Albuquerque","state":"New Mexico","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University at Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Medical College of Cornell University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewYork Presbyterian - Queens","city":"Queens","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Staten Island University Hospital-Northwell Health","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stony Brook University","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westchester Medical Center","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"White Plains Hospital","city":"White Plains","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest Baptist Health","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Lindner Center for Research and Education at The Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati College of Medicine","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OhioHealth Research Institute","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wooster Community Hospital","city":"Wooster","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiology Consultants of Philadelphia","city":"Paoli","state":"Pennsylvania","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James River Cardiology","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Medical Center Tacoma","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin Froedtert Hospital","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shea Smith","phone":"","email":"sgluhm@stanford.edu"}],"primaryOutcomes":["To assess whether AFSW-guided, time-delimited DOAC therapy is non-inferior to continuous DOAC therapy for a composite endpoint that includes: (1) Ischemic stroke; (2) Systemic embolism; (3) All-cause mortality."],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","los-angeles-california","sacramento-california","san-diego-california","san-francisco-california","stanford-california","aurora-colorado","littleton-colorado","washington-d-c-district-of-columbia","clearwater-florida","gainesville-florida","jacksonville-florida","miami-florida","sarasota-florida","stuart-florida","winter-haven-florida","atlanta-georgia","warner-robins-georgia","chicago-illinois","elk-grove-village-illinois","evanston-illinois","naperville-illinois","indianapolis-indiana","iowa-city-iowa","scarborough-maine","baltimore-maryland","boston-massachusetts","burlington-massachusetts","worcester-massachusetts","detroit-michigan","grand-rapids-michigan","royal-oak-michigan","ypsilanti-michigan","duluth-minnesota","minneapolis-minnesota","kansas-city-missouri","st-louis-missouri","flemington-new-jersey","hackensack-new-jersey","piscataway-new-jersey","ridgewood-new-jersey","albuquerque-new-mexico","buffalo-new-york","new-york-new-york","queens-new-york","staten-island-new-york","stony-brook-new-york","valhalla-new-york","white-plains-new-york","chapel-hill-north-carolina","winston-salem-north-carolina","cincinnati-ohio","columbus-ohio","wooster-ohio","oklahoma-city-oklahoma","paoli-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","wyomissing-pennsylvania","providence-rhode-island","charleston-south-carolina","columbia-south-carolina","austin-texas","dallas-texas","houston-texas","salt-lake-city-utah","charlottesville-virginia","richmond-virginia","tacoma-washington","madison-wisconsin","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 3: testing Continuous DOAC therapy for Atrial Fibrillation","inPlainEnglish":"REACT-AF is a multicenter prospective, randomly assigned, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.","whoItsFor":["Ages 22 Years to 85 Years","22-85 years of age","English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated","History of non-permanent atrial fibrillation","The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study","Willing and able to comply with the protocol, including:","Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan","Be willing to wear the smart watch for the suggested minimum of 14 hours a day"],"whoShouldSkip":["Valvular or permanent atrial fibrillation","Current treatment with warfarin and unwilling or unable to take a DOAC","The participant is a woman who is pregnant or nursing","The participant is being treated with chronic daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration. Use of low-dose aspirin is permitted","Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months","Any documented single AF episode lasting ≥ 1 hour on a cardiac monitor performed within 90 days prior to randomization","Ablation for AF within the last 2 months"],"whatHappens":"If you join, the listed intervention(s) are AFSW Guided DOAC, or Continuous DOAC therapy. The registry lists allocation as randomized. REACT-AF is a multicenter prospective, randomly assigned, open-label, blinded endpoint (PROBE design), controlled trial comparing the current Standard Of Care (SOC) of continuous Direct Oral Anticoagulation (DOAC) use versus time-delimited (1 month) DOAC guided by an AF-sensing Smart Watch (AFSW) in participants with a history of paroxysmal or persistent Atrial Fibrillation (AF) and low-to-moderate stroke risk.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 5,350 people at 93 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.744Z"},{"nctId":"NCT05837624","title":"Estetrol/Drospirenone to Reduce the Average Size of Endometriomas","officialTitle":"Estetrol/Drospirenone to Reduce the Average Size of Endometriomas","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Andrew Zakhari","sponsorClass":"OTHER","summary":"Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or \"chocolate cysts\"). These cysts directly impact fertility and ovarian reserve (ie. ability to have children) and can cause additional symptoms in women such as added pain, discomfort, and surgical emergencies (cyst rupture, or more rarely twisting). While endometriomas tend to require surgical excision as a solution, medical management with a variety of medications has been shown to be effective in reducing their size.\n\nMedical management (ie. medications and treatments that don't involve surgery) to reduce cyst size can help relieve symptoms either as a long term solution, before fertility treatments, or temporarily until surgery can be offered. Because the COVID-19 pandemic caused significantly reduced access to surgery and resources, medical management has become important for relief of the overburdened healthcare network.\n\nThe purpose of this study is to see how effective Estetrol/drospirenone, a combined oral contraceptive (COC), is in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment.\n\nThis single arm interventional study will recruit women 18 years or older with an ovarian endometrioma of at least 3cm, who are seeking a hormonal treatment for their endometrioma(s). Consenting participants of the study will take Estetrol/drospirenone once daily, orally, for a 6 month duration. An ultrasound assessment of ovarian endometrioma(s) will be performed before starting the drug (0 months), and will be repeated at 3-months and 6-months time. At each of these hospital visits (0, 3 \\& 6 months), participants will have their weight and blood pressure measured, and they will complete questionnaires regarding their endometriosis symptoms, incidence of amenorrhea, compliance and incidence of any adverse effects.","conditions":["Ovarian Endometrioma","Endometrioma"],"keywords":["Estetrol/drospirenone","Nextstellis","Endometriosis","volume reduction","ultrasound","Estetrol-drospirenone"],"interventions":[{"type":"DRUG","name":"Estetrol/Drospirenone"}],"enrollment":21,"startDate":"2024-12-03","completionDate":"2027-07","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Equal to or greater than 18 years old\n* Has at least one ovarian endometrioma, of at least 3 cm\n* Seeking a hormonal treatment for their endometrioma(s)\n\nExclusion criteria:\n\n* Any allergy or contraindication to the study drug\n* Inability to provide informed consent\n* Any hormone use, from the following list, within last 3 months (excluding hormones used for ovarian stimulation for fertility treatments): Estrogen (agonist or antagonist), Progestogen (agonist or antagonist), Androgen (agonist or antagonist), GnRH (agonist or antagonist), Cabergoline","locations":[{"facility":"McGill University Health Center","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrew Zakhari, M.D.","phone":"5142288889","email":"andrew.zakhari@mcgill.ca"},{"name":"Cassandra Della Rocca, BSc.","phone":"","email":"cassandra.dellarocca@rimuhc.ca"}],"primaryOutcomes":["Change in ovarian endometrioma volume at 6-months (from baseline)"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Phase 4: testing Estetrol/Drospirenone for Ovarian Endometrioma","inPlainEnglish":"Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or \"chocolate cysts\").","whoItsFor":["Ages 18 Years to any","Women only","Equal to or greater than 18 years old","Has at least one ovarian endometrioma, of at least 3 cm","Seeking a hormonal treatment for their endometrioma(s)"],"whoShouldSkip":["Any allergy or contraindication to the study drug"],"whatHappens":"If you join, the listed intervention(s) are Estetrol/Drospirenone. The registry lists allocation as na. Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 21 people at Montreal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.108Z"},{"nctId":"NCT05837897","title":"A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease","officialTitle":"A Phase 3, Multicenter, Randomized, Parallel-Group, Double-blind, Placebo-Controlled Induction Study Followed by an Open-label Extension Period to Evaluate the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Subjects in China With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks. There will be up to 20 study visits over 58 weeks to complete assessments.","conditions":["Crohn's Disease"],"keywords":["Drug therapy"],"interventions":[{"type":"DRUG","name":"Vedolizumab IV"},{"type":"DRUG","name":"Placebo"}],"enrollment":408,"startDate":"2023-06-16","completionDate":"2030-03-08","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence corroborated by a histopathology report. Cases of CD established at least 6 months before randomization for which a histopathology report is not available will be considered based on the weight of evidence supporting the diagnosis and excluding other potential diagnoses, and must be discussed with the sponsor on a case-by-case basis before randomization.\n2. The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy.\n3. The participant has CD involvement of the ileum and/or colon, at a minimum.\n4. A participant with extensive colitis or pancolitis of \\>8 years duration or limited colitis of \\>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months before initial screening (may be performed during screening if not performed in previous 12 months).\n5. A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \\>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening).\n6. The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:\n\n   * Corticosteroids.\n   * Immunomodulators.\n   * TNF-α antagonists.\n\nExclusion Criteria:\n\nI. Gastrointestinal (GI) Exclusion Criteria:\n\n1. The participant has evidence of abdominal abscess at the initial screening visit.\n2. The participant has had extensive colonic resection, subtotal or total colectomy.\n3. The participant has a history of \\>3 small bowel resections or diagnosis of short bowel syndrome.\n4. The participant has received tube feeding, defined formula diets, or parenteral alimentation within 21 days before administration of the first dose of study drug.\n5. The participant has had ileostomy, colostomy, known fixed symptomatic stenosis of the intestine, or evidence of fixed stenosis, or small bowel stenosis with prestenotic dilation.\n6. Within 30 days before randomization, the participant has received any of the following for the treatment of underlying disease:\n\n   * Nonbiologic therapies (eg, cyclosporine, thalidomide) other than those specifically listed in the Permitted Medications and Treatments section.\n   * An approved or investigational nonbiologic therapy in an investigational protocol.\n7. The participant has received traditional Chinese medication (TCMs) within 30 days before randomization.\n8. The participant has had previous exposure to approved or investigational anti-integrins including, but not limited to natalizumab, efalizumab, etrolizumab, or abrilumab (AMG-181), or mucosal vascular addressin cell adhesion molecule 1 (MAdCAM-1) antagonists, or rituximab.\n9. The participant has had previous exposure to vedolizumab.\n10. The participant has used topical (rectal) treatment with 5-aminosalicylic acid (5-ASA), corticosteroid enemas/suppositories or traditional Chinese medications for CD treatment within 2 weeks of the administration of the first dose of study drug.\n11. The participant requires currently or is anticipated to require surgical intervention for CD during the study.\n12. The participant has a history or evidence of adenomatous colonic polyps that have not been removed.\n13. The participant has a history or evidence of colonic mucosal dysplasia including low or high-grade dysplasia, as well as indeterminate for dysplasia.\n\n    II. Infectious Disease Exclusion Criteria\n14. The participant has evidence of active infection during the screening period.\n15. The participant has evidence of treatment for Clostridioides difficile (C difficile) infection or other intestinal pathogen within, 28 days before first dose of study drug.\n16. The participant has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection.\n17. The participant has active or latent tuberculosis (TB).\n18. The participant has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus \\[HIV\\] infection, organ transplantation).\n19. The participants has received any live vaccinations within 30 days before screening.\n20. The participant has a clinically significant active infection (eg, pneumonia, pyelonephritis, or coronavirus disease 2019 \\[COVID-19\\]) within 30 days before screening or during screening, or has an ongoing chronic infection or any ongoing COVID-19-related symptom(s), if previously diagnosed as having COVID-19.\n\n    III. General Exclusion Criteria\n21. The participant has had any surgical procedure requiring general anesthesia within 30 days before enrollment or is planning to undergo major surgery during the study period.\n22. The participant has any history of malignancy, except for the following: (a) adequately-treated nonmetastatic basal cell skin cancer; (b) squamous cell skin cancer that has been adequately treated and has not recurred for at least 1 year before randomization; and (c) history of cervical carcinoma in situ that has been adequately treated and has not recurred for at least 3 years before randomization. Participants with remote history of malignancy (eg, \\>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and the therapy received and must be discussed with the sponsor on a case-by-case basis before randomization.\n23. The participant has a history of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.","locations":[{"facility":"The Second Hospital of Anhui Medical University","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yijishan Hospital of Wannan Medical College","city":"Wuhu","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital - Changqiao Campus","city":"Beijing","state":"Beijing Municipality","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Fujian Medical University","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lanzhou University Second Hospital","city":"Lanzhou","state":"Gansu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Foshan","city":"Foshan","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Sun Yat-sen University - Main","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangzhou First People's Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guangzhou Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Third Affiliated Hospital, Sun Yat-Sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Sixth Affiliated Hospital, Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huizhou Central People's Hospital","city":"Huizhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qingyuan People's Hospital","city":"Qingyuan","state":"Guangdong","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The University of Hong Kong - Shenzhen Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fifth Affiliated Hospital Sun Yat-Sen University","city":"Zhuhai","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Hebei Medical University - Main","city":"Shijiazhuang","state":"Hebei","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The 2nd Affliated Hospital of Harbin Medical University","city":"Haerbin","state":"Heilongjiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanyang First People's Hospital","city":"Nanyang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Tongji Medical College Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renmin Hospital of Wuhan University - Main Campus","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhou No.2 People's Hospital - Yanling Campus","city":"Changzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongda Hospital, Affiliated to Southeast University","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changshu No.2 People's Hospital","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xuzhou Central Hospital","city":"Xuzhou","state":"Jiangsu","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Yancheng No.1 People's Hospital","city":"Yancheng","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Jiangsu University","city":"Zhenjiang","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanchang University - Donghu Campus","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengjing Hospital of China Medical University - Nanhu Campus","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"People's Hospital of Ningxia Hui Aotonomous Region","city":"Yinchuan","state":"Ningxia","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Yantai Yuhuangding Hospital","city":"Yantai","state":"Shandong","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Zhongshan Hospital Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Shanghai East Hospital - Main","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Changhai Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Yunnan Province","city":"Kunming","state":"Yunnan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Ningbo University - Fangqiao Campus","city":"Ningbo","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"People's Hospital of Quzhou","city":"Quzhou","state":"Zhejiang","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province - Main","city":"Taizhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Wenling","city":"Taizhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The 1st Affiliated Hospital of Wenzhou Medical University - Nanbaixiang Campus","city":"Wenzhou","state":"Zhejiang","country":"China","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Takeda Contact","phone":"+1-877-825-3327","email":"medinfoUS@takeda.com"}],"primaryOutcomes":["Percentage of Participants Achieving Clinical Response at Week 14"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["hefei-china","wuhu-china","beijing-china","fuzhou-china","lanzhou-china","foshan-china","guangzhou-china","huizhou-china","qingyuan-china","shenzhen-china","zhuhai-china","shijiazhuang-china","haerbin-china","nanyang-china","wuhan-china","changsha-china","changzhou-china","nanjing-china","suzhou-china","xuzhou-china","yancheng-china","zhenjiang-china","nanchang-china","shenyang-china","yinchuan-china","yantai-china","shanghai-china","tianjin-china","kunming-china","hangzhou-china","ningbo-china","quzhou-china","taizhou-china","wenzhou-china"],"enrichment":{"headline":"Phase 3: testing Vedolizumab IV for Crohn's Disease","inPlainEnglish":"This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China. Participants will receive an injection of Vedolizumab 300 mg at scheduled weeks 0, 2, and 6, and starting at week 14, every 8 weeks over 58 weeks or starting at week 18, every 4 weeks over 54 weeks.","whoItsFor":["Ages 18 Years to 80 Years","The participant has moderately to severely active CD as determined by a 2-component patient-reported outcome (PRO2) score of 14 to 34 points and a Simple Endoscopic Score for Crohn's Disease (SES-CD) score of ≥6 (or ≥4 in cases of isolated ileitis) on screening ileocolonoscopy","The participant has CD involvement of the ileum and/or colon, at a minimum","A participant with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \\>50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening)","The participant has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:"],"whoShouldSkip":["I. Gastrointestinal (GI)"],"whatHappens":"If you join, the listed intervention(s) are Vedolizumab IV, or Placebo. The registry lists allocation as randomized. This is a study to evaluate vedolizumab for injection (300 mg) as a safe and active treatment for Crohn's Disease in adults in China.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 408 people at 43 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.901Z"},{"nctId":"NCT05844982","title":"Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy","officialTitle":"A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Jaeb Center for Health Research","sponsorClass":"OTHER","summary":"This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.","conditions":["Radiation Retinopathy","Visual Impairment"],"keywords":["Visual Acuity","Radiation retinopathy","Faricima","Fluocinolone Acetonide"],"interventions":[{"type":"DRUG","name":"Faricimab"},{"type":"DRUG","name":"fluocinolone acetonide"}],"enrollment":600,"startDate":"2023-11-21","completionDate":"2029-12-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n* Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy\n* Absence of unrelated cause of visual loss\n* Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better)\n* Posterior tumor margin \\>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)\n* Posterior tumor margin \\>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)\n* Calculated total dose to center of the macula ≥30 Gy\n\nKey Exclusion Criteria\n\n* Opaque media\n* Inability to undergo fluorescein angiography\n* Less than 18 years of age\n* Prior vitrectomy\n* Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline\n* IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge","locations":[{"facility":"Byers Eye Institute at Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants","city":"Manchester","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Florida, LLC","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Eye Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Memorial Group","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IL Eye and Ear Infirmary-University of Illinois at Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Eye Institute","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Department of Ophthalmology and Visual Sciences","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky Advanced Eye Care","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts Eye and Ear","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Foundation for Vision Research and Retina Specialists of Michigan, P.C.","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associated Retinal Consultants, P.C.","city":"Royal Oak","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University Ophthalmology","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Research Institute, LLC","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Eye Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine","city":"Celveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina-Vitreous Consultants, Inc.","city":"Monroeville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wills Eye Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pittsburgh Clinical Trial Consortium","city":"Sewickley","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Carolina, PA","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeastern Retina Associates","city":"Hixson","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Retina, PC","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas, PA","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eye Cancer Associates of Texas","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Board of Regents of the University of Wisconsin System","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cynthia Stockdale, MPH","phone":"8139758690","email":"DRCRNET@JAEB.ORG"}],"primaryOutcomes":["Change in visual acuity from baseline","Loss of 15 or more letters of visual acuity from baseline"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["faricimab"],"locationSlugs":["palo-alto-california","manchester-connecticut","tampa-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","iowa-city-iowa","lexington-kentucky","boston-massachusetts","grand-rapids-michigan","royal-oak-michigan","rochester-minnesota","st-louis-missouri","durham-north-carolina","celveland-ohio","portland-oregon","monroeville-pennsylvania","philadelphia-pennsylvania","sewickley-pennsylvania","greenville-south-carolina","hixson-tennessee","nashville-tennessee","bellaire-texas","dallas-texas","houston-texas","lubbock-texas","madison-wisconsin"],"enrichment":{"headline":"Phase 3: testing Faricimab for Radiation Retinopathy","inPlainEnglish":"This randomly assigned controlled trial will measure the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.","whoItsFor":["Ages 18 Years to any","Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy","Absence of unrelated cause of visual loss","Baseline visual acuity ≥ 34 letters (20/200 Snellen equivalent or better)","Posterior tumor margin \\>0 mm from the center of the macula (i.e., tumor is NOT under the geometric center of the fovea)","Posterior tumor margin \\>0 mm from the closest disc margin (i.e., tumor is not touching the edge of the optic disc)","Calculated total dose to center of the macula ≥30 Gy"],"whoShouldSkip":["Inability to undergo fluorescein angiography","Less than 18 years of age","Intraocular pressure (IOP) ≥ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline","IOP ≥ 25 mmHg at randomization or increase in IOP ≥ 8 mmHg from baseline to randomization (following steroid challenge"],"whatHappens":"If you join, the listed intervention(s) are Faricimab, or fluocinolone acetonide. The registry lists allocation as randomized. This randomly assigned controlled trial will measure the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.128Z"},{"nctId":"NCT05845450","title":"Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)","officialTitle":"Window-of-opportunity Umbrella Platform Trial of Short-course Pre-operative Targeted Treatments in Patients With Molecularly Selected and Resectable Primary Colorectal Cancer: the UNICORN Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gruppo Oncologico del Nord-Ovest","sponsorClass":"OTHER","summary":"This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.","conditions":["Colorectal Cancer","Resectable Colorectal Carcinoma"],"keywords":["targeted treatment","molecular alterations","platform trial"],"interventions":[{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Durvalumab"},{"type":"DRUG","name":"Panitumumab"},{"type":"DRUG","name":"Botensilimab"},{"type":"DRUG","name":"Balstilimab"},{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Vorbipiprant"},{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Amivantamab"},{"type":"DRUG","name":"Botensilimab"},{"type":"DRUG","name":"Balstilimab"}],"enrollment":197,"startDate":"2023-05-11","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nGeneral inclusion criteria\n\n* Provide a signed and dated informed consent document.\n* Age ≥ 18 years at time of informed consent.\n* ECOG PS of 0 and 1.\n* Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment.\n* Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study.\n* Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):\n\n  * ≤ T3a defined at the MRI (perivisceral fat infiltration \\<2 mm) and clinical N0\n  * Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge.\n  * Absence of mesorectal fascia invasion, as defined as a distance ≥ 1 mm between tumor and the mesorectal fascia.\n* Able to provide enough archival FFPE tumor specimen that is already available from initial diagnostic procedures for the purpose of molecular pre-screening.\n* Presence of one of the selected molecular profile/alteration after central pre-screening and necessary for the assignment to a matching treatment cohort.\n* No prior systemic treatment for colorectal cancer or neoadjuvant radiation therapy for rectal cancer.\n* Adequate bone marrow function (absolute neutrophil count ≥ 1.5 × 109/L; platelet count ≥ 100 × 109/L; hemoglobin ≥ 9.0 g/dL)\n* Adequate renal function characterized by serum creatinine ≤ 1.5 × upper limit of normal (ULN) or calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min at screening.\n* Adequate hepatic function (serum total bilirubin ≤ 1.5 × ULN and \\< 2 mg/dL. Note: Patients who have a total bilirubin level 1.5 × ULN will be allowed if their indirect bilirubin level is ≤ 1.5 × ULN; Alanine aminotransferase and/or aspartate aminotransferase ≤ 2.5 × ULN).\n* Women of childbearing potential must have a negative blood pregnancy test at the baseline visit. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n* Subjects and their partners must be willing to avoid pregnancy during the trial and until a specific time interval after the last trial treatment: 7 months for female and 4 for male patients after last dose of trastuzumab-deruxtecan, 3 months for durvalumab, botensilimab and balstilimab and 2 months for panitumumab. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the Investigator (barrier contraceptive measure or oral contraception).\n* Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nSpecific inclusion criteria for each Cohort\n\nCOHORT 1: pMMR/MSS status and HER2-positive status and LVEF ≥ 50% within 28 days before enrolment, international normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN\n\nCOHORT 2: Proofread domain mutations in POLE or POLD1 associated with ultra-mutated status, i.e. tumor mutational burden \\>100 Mut/Mb.\n\nCOHORT 3: pMMR/MSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative), Left-sided and rectal primary tumor location, according to the specific inclusion criterion regarding rectal tumors.\n\nCOHORT 4: pMMR/MSS status and absence of HER2 overexpression/amplification, absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status and absence of KRAS G12C mutation.\n\nCOHORT 5: pMMR/MSS status and absence of of HER2 overexpression/amplification, absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 6: dMMR/MSI-H status and absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 7: dMMR/MSI-H status and absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status.\n\nCOHORT 8: pMMR/MSS status and KRAS G12C mutation, absence of HER2 overexpression/amplification and wild-type status for BRAF.\n\nCOHORT 9: pMMR/MSS status and absence of of HER2 overexpression/amplification, absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation.\n\nCOHORT 10: pMMR/MSS status and absence of of HER2 overexpression/amplification, absence of POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation.\n\nCOHORT 11: pMMR/MSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative except for MET alterations - MET amplifications and mutations are allowed), Left-sided and rectal primary tumor location, according to the specific inclusion criterion regarding rectal tumors.\n\nCOHORT 12: pMMR/MSS status and wild-type status for RAS and BRAF, absence of molecular predictors of resistance (PRESSING panel negative except for MET alterations - MET amplifications and mutations are allowed), Right-sided primary tumor location.\n\nCOHORT 1 of UNICORN part 2 (to enroll sequentially after completion of cohort 10): pMMR/MSS status and absence of molecular characteristics allowing enrollment in cohorts 1,2 and 8 (i.e HER2 overexpression/amplification, POLE/D1 proof-read domain pathogenic mutation associated with ultra-mutated status, absence of KRAS G12C mutation. Patients with tumor characteristics of EGFR dependency (regardless of MET) will be eligible for cohort 1 of UNICORN part 2 only after completion of cohort 11 or 12 (depending on primary tumor sidedness) and upon discussion with the Sponsor\n\nExclusion Criteria:\n\nGeneral exclusion criteria\n\n* Distant metastases at any site, as defined by negativity of chest/abdomen/pelvis contrast-enhanced computed tomography (CT).\n* Risk criteria for obstructing disease at radiology or endoscopy as defined in the pivotal FOxTROT study.\n* Need to receive neoadjuvant radiation or chemoradiation in patients with rectal cancer.\n* Patients with known hypersensitivity to the study drug of the assigned cohort or to its excipients or to drugs belonging to the same drug class.\n* Previous or concurrent malignancy within 2 years of study entry.\n* Impaired cardiovascular function or clinically significant cardiovascular diseases, including any of the following: history of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤ 6 months prior to start of study treatment; symptomatic congestive heart failure (i.e., Grade 2 or higher), history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality ≤ 6 months prior to start of study treatment, except atrial fibrillation and paroxysmal supraventricular tachycardia.\n* Known history of HIV infection.\n* Active infection including tuberculosis, hepatitis B, hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible only in case of negativity of HBV DNA. Patients positive for hepatitis C (HCV) antibody are eligible only if PCR is negative for HCV RNA.\n* Other severe acute or chronic diseases that may increase the risk associated with study participation or study drug administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.\n* Any psychiatric condition that would prohibit the understanding or rendering of informed consent and that would limit compliance with trial requirements.\n* Women in pregnancy or lactation condition. Women with child-bearing potential or sexually-active men not willing to use adequate contraception during whole study period.\n* Use of any disallowed drugs.\n\nSpecific exclusion criteria for each Cohort:\n\nCOHORT 1:\n\n* Previous treatment with a DXd-containing ADC or any anti-HER2 agent.\n* Has LVEF\\< 50% within 28 days before enrolment.\n* Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. (eg, pulmonary emboli within 3 months of the enrolment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the enrolment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.).\n* Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of, pulmonary involvement at the time of Screening.\n* Prior pneumonectomy.\n* Has substance abuse or any other medical conditions that may interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n* Patients with a medical history of myocardial infarction within 6 months before randomization/enrolment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out myocardial infarction.\n* Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\>450 msec (males) based on average of the screening triplicate12-lead ECG.\n* A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).\n\nCOHORT 2, 4, 5, 6, 7, 10 and Cohort 1 of UNICORN part 2:\n\n* History of autoimmune diseases or history of bone marrow or organ transplantation that requires immunosuppressive therapy.\n* History of active primary immunodeficiency.\n* Any condition requiring systemic treatment with corticosteroids at doses equal or superior to 10 mg daily of prednisone or equivalents, or other immunosuppressive drugs within 14 days from the inclusion in the study.\n* Administration of live vaccines within 4 weeks from the inclusion in the study. Note: patients, if enrolled, should not receive live vaccine while receiving study drug(s) and up to 30 days after the last dose of study drug(s).\n* Prior treatment with anti-CTLA4, anti-PD-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents.\n\nCOHORT 3 and 8\n\n* History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan.\n* Magnesium below the LNL.\n* Prior treatment with an EGFR inhibitor.\n\nCOHORT 8:\n\n* Patients who are unable to take a drug by mouth or previous clinical conditions or surgical resection that may affect the absorption of the study drug.\n* Use of CYP3A4 or P-gp substrates with a narrow therapeutic window within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer.\n* Use of any herbal medications/supplements.\n* Tumors with KRAS, NRAS, HRAS, BRAF or PTPN11 (SHP2) mutations, except KRAS G12C.\n* Prior treatment with a KRAS G12C inhibitor.\n\nCOHORT 9 and 10:\n\n* Prior treatment with EP4 receptor antagonists.\n* Inability to swallow medications.\n* Presence of portal hypertension and/or oesophageal varices.\n* Known severe gastritis, duodenal or gastric ulcer, or any other condition that may lead to bleeding or perforation.\n\nCOHORTS 11 and 12:\n\n* Prior treatment with an anti-EGFR and/or MET inhibitor.\n* History of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest CT scan\n* Clinically active infectious liver disease\n* Any ophthalmologic condition that is clinically unstable","locations":[{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori di Milano","city":"Milan","state":"Lombardia/MI","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Filippo Pietrantonio, MD","phone":"+39 0223903807","email":"filippo.pietrantonio@istitutotumori.mi.it"},{"name":"Federica Palermo","phone":"+39 0223903835","email":"unicornstudy@istitutotumori.mi.it"}],"primaryOutcomes":["major pathological response rate"],"hasResults":false,"conditionSlugs":["colorectal-cancer","als"],"drugSlugs":["nivolumab","trastuzumab-deruxtecan","sotorasib"],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Phase 2: testing Trastuzumab deruxtecan for Colorectal Cancer","inPlainEnglish":"This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration. The study aims to test the activity of specific targeted agents/combinations given as a short-course pre-operative strategy, matched with the specific alteration detected, followed by standard of care surgery.","whoItsFor":["Ages 18 Years to any","General who can join","ECOG PS of 0 and 1","Histologically confirmed colorectal cancer adenocarcinoma that is judged as initially resectable with elective surgery aimed at radical intent with R0 margins as per multidisciplinary team assessment","Radiological stage cT3-4, N0-2, M0 using computed tomography (CT) as in the pivotal FOxTROT study","Patients with rectal cancer candidate for R0 resection, not requiring pre-operative radiotherapy based on multidisciplinary team assessment, with the following characteristics on high-resolution thin slice (3 mm) contrast-enhanced magnetic resonance imaging (MRI):","≤ T3a defined at the MRI (perivisceral fat infiltration \\<2 mm) and clinical N0","Upper-medium, defined as tumors with distal margin ≥ 5 cm from the anal verge"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab deruxtecan, Durvalumab, or Panitumumab. The registry lists allocation as randomized. This is a window-of-opportunity umbrella platform trial enrolling non-metastatic resectable colorectal patients selected for the presence of a specific targetable molecular alteration.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 197 people at Milan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.969Z"},{"nctId":"NCT05851859","title":"Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital","officialTitle":"Randomized Controlled Trial Evaluating the Effectiveness of a Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Centre Hospitalier Universitaire de la Réunion","sponsorClass":"OTHER","summary":"Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: \" symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition \". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time.\n\nThe Reunion Island is a French overseas department located in the Indian Ocean accounting more than 860,000 inhabitants. It has recorded since March 11, 2020, nearly 491,825 cases of COVID-19 and 961 deaths of hospitalized patients. Reunion's population is multi-ethnic and younger than the metropolitan France's one. It also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of COVID-19. This specific context makes this island a particular study site for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Long COVID.\n\nIn addition, some studies have confirmed the involvement of the autonomic nervous system (ANS) in the symptomatology of Long COVID and demonstrated that patients with a Long COVID present a dysfunction of their ANS which is objectified by a reduced Heart Rate Variability (HRV). The regulation of heart rate by the ANS is strongly favored by respiration. A regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. The result of this training is an induced state called \"cardiac coherence\" (CC).\n\nThe investigator therefore hypothesize that respiratory training to CC could \"re-educate\" the ANS and durably improve the symptomatology of patients with Long COVID.","conditions":["Long COVID"],"keywords":[],"interventions":[{"type":"OTHER","name":"Cardiac coherence"}],"enrollment":200,"startDate":"2025-05-05","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients over the age of 18,\n* living in Reunion and\n* having a diagnosis of Long COVID according to the World Health Organization (WHO) definition will be included in this study.\n* These patients must attest to their primary infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and present a negative antigen test at the time of inclusion.\n\nExclusion Criteria:\n\nPatients:\n\n* with a chronic or disabling respiratory pathology preventing respiratory training (asthma, Chronic Obstructive Pulmonary Disease (COPD), active tuberculosis, pulmonary sequelae of COVID-19, etc.) practicing or having practiced a regular respiratory control technique (yoga, Cardiac coherence training, etc.) in the last 6 months\n* taking a beta-blocker, betamimetic, anti-arrhythmic, morphine, antidepressant treatment (Escitalopram)\n* having a pacemaker or severe heart disease\n* Current and known pregnancy or breastfeeding woman\n* with a cognitive deficit\n* under guardianship/curators or under judicial protection","locations":[{"facility":"CHU de la Réunion","city":"Saint-Denis","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de la Réunion","city":"Saint-Pierre","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Léa BRUNEAU","phone":"02 62 90 68 83","email":"lea.bruneau@chu-reunion.fr"}],"primaryOutcomes":["Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID."],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity","long-covid"],"drugSlugs":[],"locationSlugs":["saint-denis-france","saint-pierre-france"],"enrichment":{"headline":"Not a traditional drug phase: Cardiac coherence for Long COVID","inPlainEnglish":"Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: \" symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition \". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time.","whoItsFor":["Ages 18 Years to any","Patients over the age of 18,","living in Reunion and","having a diagnosis of Long COVID according to the World Health Organization (WHO) definition will be included in this study","These patients must attest to their primary infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and present a negative antigen test at the time of inclusion"],"whoShouldSkip":["taking a beta-blocker, betamimetic, anti-arrhythmic, morphine, antidepressant treatment (Escitalopram)","having a pacemaker or severe heart disease","Current and known pregnancy or breastfeeding woman","with a cognitive deficit","under guardianship/curators or under judicial protection"],"whatHappens":"If you join, the listed intervention(s) are Cardiac coherence. The registry lists allocation as randomized. Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: \" symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition \".","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.241Z"},{"nctId":"NCT05852717","title":"Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","officialTitle":"A Phase II Trial Evaluating Safety and Efficacy of Epcoritamab With Gemcitabine, Dexamethasone, and Cisplatin (GDP) Salvage Chemotherapy in Relapsed Refractory Large B-cell Lymphoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Vijendra Singh","sponsorClass":"OTHER","summary":"Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. Each cycle will last 21 days. GDP consists of gemcitabine 1000 mg/m2 IV on Days 1 and 8, cisplatin 75 mg/m2 IV on Day 1, and dexamethasone 40 mg orally on Days 1 through 4. Epcoritamab will be administered subcutaneously (SC) on Days 1, 8, and 15. Patients will receive granulocyte colony stimulating factor (G-CSF) between Day 8 through Day 10 of each cycle of combination therapy.\n\nPatients will then undergo radiology imaging for disease assessment. Patients may proceed to SCT(autologous or allogeneic) or CAR T-cell therapy or epcoritamab monotherapy upon completion of Cycle 3 per investigator discretion. The rationale for subjects not proceeding to autoSCT or CAR T-cell therapy will be captured in the eCRFs.\n\nPatients who do not undergo SCT or CAR T-cell therapy may have the option to receive study treatment with epcoritamab monotherapy following completion of Cycle 3. Epcoritamab monotherapy will be offered to selected subjects who become ineligible to undergo SCT or CAR T-cell therapy (such as social situation, change in subject decision). The decision to offer epcoritamab monotherapy will be per investigator's discretion. However, subjects must have demonstrated a response to the combination therapy (partial remission or complete remission) per disease assessment scans prior to offering epcoritamab monotherapy. Epcoritamab monotherapy should begin 2 weeks following Cycle 3 Day 15. Monotherapy will consist of epcoritamab 48 mg administered subcutaneously on Days 1 and 15 of each 28 day cycle for Cycle 4 to Cycle 9 or until unacceptable toxicity, or disease progression per the Lugano Criteria.","conditions":["Large Cell Lymphoma, Diffuse","Relapsed Cancer","Refractory Cancer"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"AutoSCT OR CAR T-cell Therapy"},{"type":"DRUG","name":"GDP"},{"type":"DRUG","name":"Epcoritamab"}],"enrollment":35,"startDate":"2023-10-31","completionDate":"2027-11-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0-2 within 28 days prior to registration.\n4. Histologically confirmed CD20+ relapsed large cell lymphoma according to the 5th edition of the WHO classification of the hematolymphoid tumors and the 2022 international consensus classification of mature lymphoid neoplasms. This includes de-novo and transformed from prior indolent B-cell NHL such as follicular lymphoma, or marginal zone lymphoma (33, 34). Subjects with high-grade B-cell lymphoma (HGBCL), NOS subtype, and high-grade B-cell lymphoma with c-MYC, Bcl2 and/or Bcl6 rearrangements (double or triple hit lymphoma) are eligible. Patients with primary mediastinal B-cell lymphoma, and T-cell histiocyte-rich B-cell lymphoma, primary cutaneous diffuse large B-cell lymphoma, leg type, Intravascular large B-cell lymphoma, Epstein-Barr virus-positive diffuse large B-cell lymphoma, NOS, Diffuse large B-cell lymphoma associated with chronic inflammation, and ALK-positive large B-cell lymphoma are eligible. Patients with Burkitt lymphoma or lymphoplasmacytic lymphoma are not eligible.\n5. Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014).\n6. Have received at least 1 prior line of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy.\n7. Patients must be deemed eligible to proceed with stem cell transplantation (autologous or allogeneic) or CAR T-cell therapy per treating physician discretion. Prior autologous stem cell transplantation or CAR T-cell therapy is permitted if \\> 90 days have elapsed and the patient is deemed eligible for allogeneic stem cell transplantation or CAR T-cell therapy by the investigator. Prior allogeneic stem cell transplant recipients may be eligible if they do not have active or chronic GVHD and are not receiving immunosuppression for the prophylaxis or treatment of GVHD.\n8. Must have had relapsed or refractory disease following standard frontline chemotherapy. Refractory disease is defined as large cell lymphoma not achieving complete remission, progressing, or relapsing within 6 months after first-line chemotherapy based on PET/CT per the Lugano criteria. Relapsed disease is defined as disease that recurs beyond 6 months after completion of initial chemotherapy based on PET/CT per the Lugano criteria.\n9. Archival tissue obtained within 2 years of signing consent is required if available and will be identified at screening and shipped prior to Cycle 2 Day 1. If archival tissue is not available, but the subject is undergoing a standard of care biopsy, fresh tissue from that standard of care biopsy may be used for eligibility. If a subject does not have archival tissue obtained within 2 years of signing consent or is not undergoing a standard of care biopsy, they are not eligible for the trial. Cytological or fine-needle aspiration samples are not acceptable. Tumor tissue from bone metastases that has been decalcified is not acceptable.\n10. Demonstrate adequate organ function. All screening labs to be obtained within 21 days prior to registration. \\*Patients with bone marrow involvement will be eligible to participate in the study but must meet hematologic parameters.\n11. Life expectancy of ≥ 6 months, as determined by the enrolling physician or protocol designee.\n12. Females subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study treatment. If a urine test is done and it is positice ir cannot be confirmed as negative, a serum pregnancy test will be required.\n13. Female subjects of childbearing potential and male subjects must be willing to abstain from penile-vaginal intercourse or to use an effective method(s) of contraception.\n14. As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab, or odronextamab.\n2. Known active central nervous system or meningeal involvement by large cell lymphoma at time of screening. Patients diagnosed with CNS disease who achieved and maintained CNS CR at the time of relapse are eligible. Lumbar puncture must be done in this case prior to study entry to demonstrate CNS CR status. Tests to investigate CNS involvement are required otherwise only if clinically indicated (i.e. disease suspected on basis of symptoms or other findings).\n3. Contraindication to any drug contained in the combination therapy regimen (GDP).\n4. Known hypersensitivity or allergic reaction to epcoritamab or its' excipients.\n5. Use of any standard or experimental anti-large cell lymphoma therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) \\< 14 days prior to C1D1. NOTE: Prednisone up to 50 mg or equivalent for 5 days is permitted; palliative radiation is permitted only if on non-target lesions).\n6. Major surgery \\< 14 days of Cycle 1 Day 1.\n7. Neuropathy Grade ≥ 2 (CTCAE v.5.0).\n8. Patients with a history of other malignancies, except adequately treated non-melanoma skin cancer, non-invasive superficial bladder cancer, curatively treated in-situ cancer of the cervix, DCIS of the breast, localized low grade prostate cancer (up to Gleason score 6), or other solid tumours curatively treated with no evidence of disease for at least 3 years.\n9. Active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) requiring systemic treatment within 7 days prior to the first dose of study treatment. Prophylactic antibacterial, antiviral, and antifungal agents are allowed.\n10. Active HIV infection. NOTE: Testing for HIV antibody is required at the time of screening. Those with positive HIV antibody will require HIV viral load by PCR testing. Patients with detectable viral load will not be eligible for the study. Those with positive antibody but undetectable viral load and CD4 \\>200 will be eligible.\n11. Testing for hepatitis B (HBV) and hepatitis C virus (HCV) is required at screening. Hepatitis B testing will consist of Hepatitis B surface Antigen (HBsAg), Hepatitis B Core Antibody (HBcAb) and Hepatitis Surface Antibody (HBsAb). Hepatitis C testing will consist of Hepatitis C Antibody (HCAb). Subjects with a history of chronic hepatitis B virus (HBV) infection must have an undetectable HBV viral load on suppressive therapy, if indicated. Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects with a history of hepatitis C virus (HCV) infection must have been treated. For patients with HCV infection who are currently on treatment, the HCV viral load must be undetectable to be eligible for this trial. Subjects who received treatment for HCV that was intended to eradicate the virus may participate if hepatitis C RNA levels are undetectable.\n12. Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).\n13. Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, or being compliant with the study procedures.","locations":[{"facility":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Center (Wayne State University)","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Health System","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vijendra Singh, MD","phone":"313-576-8694","email":"singhv@karmanos.org"},{"name":"Allison Lipps","phone":"317-634-5842","email":"alipps@hoosiercancer.org"}],"primaryOutcomes":["Complete Response (CR)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["indianapolis-indiana","detroit-michigan","dallas-texas","charlottesville-virginia"],"enrichment":{"headline":"Phase 2: testing GDP for Large Cell Lymphoma, Diffuse","inPlainEnglish":"Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab. GDP consists of gemcitabine 1000 mg/m2 IV on Days 1 and 8, cisplatin 75 mg/m2 IV on Day 1, and dexamethasone 40 mg orally on Days 1 through 4.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years at the time of consent","how well you can do daily activities (ECOG score) of 0-2 within 28 days prior to registration","Positron emission tomography (PET) positive measurable disease with at least 1 node having the longest diameter (LDi) greater than (\\>) 1.5 centimeter (cm) or 1 extranodal lesion with LDi \\>1 cm (per the Lugano Criteria 2014)","Have received at least 1 prior line of systemic therapy for the treatment of large cell lymphoma. NOTE: Prior radiation therapy or systemic corticosteroids will not be considered a line of therapy","Demonstrate adequate organ function. All screening labs to be obtained within 21 days prior to registration. \\*Patients with bone marrow involvement will be eligible to participate in the study but must meet hematologic parameters","Life expectancy of ≥ 6 months, as determined by the enrolling physician or protocol designee","Females subjects of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to study treatment. If a urine test is done and it is positice ir cannot be confirmed as negative, a serum pregnancy test will be required"],"whoShouldSkip":["Previous treatment with gemcitabine, cisplatin, and epcoritamab or other bispecific T-cell engager antibody (BsAB) such as glofitamab, mosunetuzumab, or odronextamab","Contraindication to any drug contained in the combination therapy regimen (GDP)","Known hypersensitivity or allergic reaction to epcoritamab or its' excipients","Major surgery \\< 14 days of Cycle 1 Day 1","Neuropathy Grade ≥ 2 (CTCAE v.5.0)","Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study)","Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety, or being compliant with the study procedures"],"whatHappens":"If you join, the listed intervention(s) are AutoSCT OR CAR T-cell Therapy, GDP, or Epcoritamab. The registry lists allocation as randomized. Subjects with relapsed large cell lymphoma will receive 3 cycles of combination therapy consisting of GDP and epcoritamab.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.406Z"},{"nctId":"NCT05856981","title":"Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors","officialTitle":"An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Sairopa B.V.","sponsorClass":"INDUSTRY","summary":"This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).","conditions":["Solid Tumor, Adult","Metastatic Solid Tumor","Refractory Cancer","CRC, Colorectal Cancer","RCC, Clear Cell Adenocarcinoma","NSCLC (Advanced Non-small Cell Lung Cancer)","Endometrial Cancer"],"keywords":["Immunotherapy"],"interventions":[{"type":"DRUG","name":"ADU-1805"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":130,"startDate":"2023-04-03","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female aged ≥18 years\n* Signed and dated informed consent form\n* Measurable disease according to RECIST (Safety Expansion only)\n* ECOG Performance status of 0 or 1\n* Adequate organ and marrow function\n* Escalation Phase: Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists\n* Expansion Phase: histologically and/or cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST\n\nExclusion Criteria:\n\n* Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)\n* Expansion Phase:\n\n  * \\> 3 lines of prior systemic treatments\n  * MSS colorectal cancer (CRC): liver metastasis present\n* Pregnancy or breast-feeding\n* Prior treatment with or receipt of:\n\n  * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805\n  * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.\n  * anti-SIRPα or anti-CD47-directed therapy\n  * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805\n  * other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805\n  * vaccine containing live virus within 28 prior to the first dose of ADU-1805\n* Active untreated brain metastases\n* Active infection requiring systemic therapy\n* Impaired cardiac function or clinically significant cardiac disease\n* Current Grade \\>2 toxicity related to prior anti-cancer therapy\n* History of drug-induced severe immune-related adverse reaction\n* Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients\n* Major surgery within defined period\n* Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis\n* Allogenic tissue/solid organ transplant\n* Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study","locations":[{"facility":"Henry Ford Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University Medical Campus","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Carolinas Medical Center","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Health - Duke University Hospital","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabrail Cancer & Research Center","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Start Center for Cancer Research - Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Hopital de Charleroi (GHdC) - Hopital Notre Dame","city":"Charleroi","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gergorio Maranon","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sairopa Clinical Team","phone":"0031 85 90 26 939","email":"clinical@sairopa.com"}],"primaryOutcomes":["Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters","Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion."],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["detroit-michigan","st-louis-missouri","charlotte-north-carolina","durham-north-carolina","canton-ohio","dallas-texas","west-valley-city-utah","fairfax-virginia","charleroi-belgium","madrid-spain"],"enrichment":{"headline":"Phase 1: testing ADU-1805 for Solid Tumor, Adult","inPlainEnglish":"This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to measure the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as this drug alone and in combination with pembrolizumab (anti-PD-1 antibody).","whoItsFor":["Ages 18 Years to any","Male or female aged ≥18 years","Measurable disease according to RECIST (Safety Expansion only)","how well you can do daily activities (ECOG score) of 0 or 1","Adequate organ and marrow function","Escalation Phase: Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists"],"whoShouldSkip":["Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)","\\> 3 lines of prior systemic treatments","MSS colorectal cancer (CRC): liver metastasis present","Pregnancy or breast-feeding","Prior treatment with or receipt of:","biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805","chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C"],"whatHappens":"If you join, the listed intervention(s) are ADU-1805, or Pembrolizumab. The registry lists allocation as randomized. This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to measure the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as this drug alone and in combination with pembrolizumab (anti-PD-1 antibody).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 130 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.927Z"},{"nctId":"NCT05858437","title":"Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD","officialTitle":"Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Charite University, Berlin, Germany","sponsorClass":"OTHER","summary":"Pro-Kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.","conditions":["CKD (Chronic Kidney Disease) Stage 5D"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Sodium propionate"},{"type":"OTHER","name":"Placebo"}],"enrollment":16,"startDate":"2024-01-15","completionDate":"2026-07-08","sex":"ALL","minAge":"12 Years","maxAge":"20 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Body weight: \\> 30kg\n* CKD G5 treated with hemodialysis\n* Continuous hemodialysis treatment for \\> 3 months\n* Clinical stable condition\n* Manifestation of CKD within childhood (\\<18 years)\n\nExclusion Criteria:\n\n* Disease or dysfunctions, which disqualifies the patient\n* Incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study\n* Acute infections\n* Immunosuppressive therapy within the last 12 weeks before the start of the study\n* Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study\n* Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study\n* Malignant diseases\n* Pregnancy\n* chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease\n* alcohol- or drug abuse\n* parallel participation on other interventional trials","locations":[{"facility":"Department of Pediatric Gastroenterology, Nephrology and Metabolic Diseases, Charité-Universitätsmedizin Berlin","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Johannes Holle, Dr. med.","phone":"004930450516012","email":"johannes-benjamin.holle@charite.de"},{"name":"Nicola Wilck, Dr. med.","phone":"004930450516012","email":"nicola.wilck@charite.de"}],"primaryOutcomes":["Change in count of regulatory T-cells from baseline to week 4"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: Sodium propionate for CKD (Chronic Kidney Disease) Stage 5D","inPlainEnglish":"Pro-Kids is a multi-center, neither you nor the study doctors know who gets the real treatment, randomly assigned and compared with a dummy treatment intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.","whoItsFor":["Ages 12 Years to 20 Years","Body weight: \\> 30kg","CKD G5 treated with hemodialysis","Continuous hemodialysis treatment for \\> 3 months","Clinical stable condition","Manifestation of CKD within childhood (\\<18 years)"],"whoShouldSkip":["Disease or dysfunctions, which disqualifies the patient","Incapacity of contract or any other circumstances, which prohibit the patient or his legal guardians from understanding setup, meaning and entity of the study","Immunosuppressive therapy within the last 12 weeks before the start of the study","Pre-/pro- or postbiotic or antibiotic therapy within the last 4 weeks before the start of the study","Planned or unplanned hospitalization within in last 4 weeks before the start of the study or during study","chronic gastrointestinal or hepatic diseases (for example chronic inflammatory bowel disease","alcohol- or drug abuse"],"whatHappens":"If you join, the listed intervention(s) are Sodium propionate, or Placebo. The registry lists allocation as randomized. Pro-Kids is a multi-center, neither you nor the study doctors know who gets the real treatment, randomly assigned and compared with a dummy treatment intervention study in children with chronic kidney disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 16 people at Berlin. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.503Z"},{"nctId":"NCT05858619","title":"Molecular Signatures of Cutaneous Dupilumab Response","officialTitle":"Molecular Signatures of Cutaneous Dupilumab Response","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"}],"enrollment":15,"startDate":"2023-02-01","completionDate":"2028-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 18 years of age or older\n2. atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7\n\nExclusion Criteria:\n\n1. Known pregnancy\n2. Known immunodeficiencies\n3. Known parasitic infection -","locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeffrey Cheng, MD, PhD","phone":"415 575 0524","email":"rashes@ucsf.edu"}],"primaryOutcomes":["Change in Eczema Area and Severity Index (EASI) score from baseline to 8-12 weeks"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Phase 4: testing Dupilumab for Atopic Dermatitis","inPlainEnglish":"This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.","whoItsFor":["Ages 18 Years to any","18 years of age or older","atopic dermatitis with a EASI (Eczema Area and Severity Index (EASI)) score of ≥7"],"whoShouldSkip":["Known immunodeficiencies","Known parasitic infection -"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab. The registry lists allocation as na. This study examines the effect of IL4RA blockade with dupilumab on the immune cells of atopic dermatitis skin lesions.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 15 people at San Francisco. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.715Z"},{"nctId":"NCT05859048","title":"Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians in Heart Failure","officialTitle":"Multidisciplinary Approach for High Risk Patients Leading to Early Diagnosis of Canadians","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Cardiology Research UBC","sponsorClass":"OTHER","summary":"The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure.\n\nThe main question\\[s\\] it aims to answer are:\n\n• will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiogram compared to usual care identify patients at risk for heart failure earlier than standard of care?\n\nParticipants will be enrolled and randomized to either standard of care (SOC) or intervention arm:\n\nSOC arm: electronic health records will be reviewed over six months for assessments performed to identify heart failure.\n\nIntervention arm: blood sample for N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) at local laboratory . For elevated NT-proBNP results (\\>125pg/ml) an artificial intelligence (AI) echocardiogram and 12 lead electrocardiogram (ECG) will be performed at study site (within 28 days of NT-proBNP result). EHR will be reviewed at six months","conditions":["Heart Failure"],"keywords":["Heart failure screening","natriuretic peptides","artificial intelligence echocardiography"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"NT-proBNP"},{"type":"DIAGNOSTIC_TEST","name":"AI echocardiogram"},{"type":"DIAGNOSTIC_TEST","name":"electrocardiogram"},{"type":"OTHER","name":"Cardiovascular physical examination"}],"enrollment":1360,"startDate":"2024-03-01","completionDate":"2027-07-01","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female \\> 40 years of age\n* Informed consent\n* At least two additional risk factors for Heart Failure (HF):\n\n  * Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis or an epicardial coronary artery (50% left main stem or \\>70% left anterior descending, circumflex or right coronary artery)).\n  * Diabetes type 1 or 2.\n  * Persistent or permanent atrial fibrillation.\n  * Previous ischemic or embolic stroke.\n  * Peripheral artery disease (previous surgical or percutaneous revascularization or documented stenosis \\>50% of major peripheral arterial vessel.\n  * Chronic kidney disease (defined as an estimated glomerular filtration rate (eGFR)\\<60 milliliters per minute (mL/min)/1.73m2 or eGFR 60-90 mL/min/1.73m2 and urine albumin-creatinine ration (UACR) \\>300mg/g).\n  * Regular loop diuretic use for \\>30 days within 12 months prior to consent.\n  * Chronic obstructive pulmonary disease (COPD) evidenced by one of the following: Pulmonary Function Test (PFT) showing airway obstruction, diagnosis of respiratory physician, CT scan reporting presence of emphysema, or treatment with national guidance advocated COPD therapy.\n\nExclusion Criteria:\n\n* Inability to give informed consent (e.g. due to significant cognitive impairment).\n* Previous diagnosis of heart failure. This is any diagnosis of heart failure with any ejection fraction of any cause.\n* Renal replacement therapy.\n* Anyone who, in the investigator's opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period.","locations":[{"facility":"Vancouver General Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Heart Institute","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Sherbrooke","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naomi Uchida, BSN","phone":"16048754521","email":"naomi.uchida@ubc.ca"},{"name":"Jennifer Petterson","phone":"604-875-5104","email":"jenny.petterson@vch.ca"}],"primaryOutcomes":["Number of participants diagnosed with heart failure (HF) according to the European Society of Cardiology 2021 HF guidelines","Number of outpatient HF visits","Number of urgent HF visit","Number of HF hospitalizations"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["vancouver-canada","montreal-canada","sherbrooke-canada"],"enrichment":{"headline":"Not a traditional drug phase: NT-proBNP for Heart Failure","inPlainEnglish":"The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure. The main question\\[s\\] it aims to answer are: • will an electronic health records (EHR) case finding algorithm for heart failure, followed by N-Terminal pro-brain natriuretic peptide (NT-proBNP) screening and artificial intelligence (AI) echocardiogram compared to usual care identify patients at risk for heart failure earlier than standard of care?","whoItsFor":["Ages 40 Years to any","Male or female \\> 40 years of age","At least two additional risk factors for Heart Failure (HF):","Diabetes type 1 or 2","Persistent or permanent atrial fibrillation","Previous ischemic or embolic stroke","Peripheral artery disease (previous surgical or percutaneous revascularization or documented stenosis \\>50% of major peripheral arterial vessel","Chronic kidney disease (defined as an estimated glomerular filtration rate (eGFR)\\<60 milliliters per minute (mL/min)/1.73m2 or eGFR 60-90 mL/min/1.73m2 and urine albumin-creatinine ration (UACR) \\>300mg/g)"],"whoShouldSkip":["Previous diagnosis of heart failure. This is any diagnosis of heart failure with any ejection fraction of any cause","Renal replacement therapy","Anyone who, in the investigator's opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period"],"whatHappens":"If you join, the listed intervention(s) are NT-proBNP, AI echocardiogram, or electrocardiogram. The registry lists allocation as randomized. The goal of this study is improve the screening of heart failure and identify patients early who are at risk of heart failure.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,360 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.433Z"},{"nctId":"NCT05866471","title":"The ENHANCE Study: taVNS and Psilocybin","officialTitle":"Activating Neuroplasticity to ENHANCE the Perception Box Expanding Effects of Psilocybin","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"TRIPLE","sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.","conditions":["Healthy","Psychedelic Experiences","Vagus Nerve Stimulation"],"keywords":["Psilocybin","Psychedelics","Vagus Nerve Stimulation","Healthy Volunteer"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DEVICE","name":"Transcutaneous auricular Vagus Nerve Stimulation (taVNS)"},{"type":"BEHAVIORAL","name":"Psychosocial Support Alone"},{"type":"OTHER","name":"Sham taVNS"}],"enrollment":115,"startDate":"2025-01-27","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* English speaking\n* Ability/willingness to complete all study activities\n* Modest reduction in emotional well-being\n* Medically healthy (does not meet criteria for an exclusionary medical condition)\n* Blood pressure and heart rate within established ranges at screening\n* Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)\n\nExclusion Criteria:\n\n* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)\n* Current or clinically significant psychiatric disorder that, in the investigator's judgment, would interfere with participation or increase risk\n* Current use of drugs or medications, prescribed or otherwise, that may interact with psilocybin\n* Use of investigational drugs, biologics, or devices within 30 days of enrollment\n* Use of psychedelic or related agents within three months of Dosing Day\n* Clinically significant electrocardiogram (ECG)\n* Vitals outside acceptable range\n* Pregnancy and currently breastfeeding\n* Unwillingness to go without tobacco products for 12 hours or more\n* Inability to undergo fMRI scanning\n* Recent ear trauma, hearing loss (if clinically significant), or deafness\n* Family history of a psychotic disorder in a first degree relative","locations":[{"facility":"University of Wisconsin - Madison","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Program Manager","phone":"608-265-4987","email":"enhance@psychiatry.wisc.edu"}],"primaryOutcomes":["Memory Experiences Questionnaire (MEM-Q-PSIL): Comparison of taVNS Administration vs. Treatment as Usual","Functional Magnetic Resonance Imaging (fMRI): Comparison of taVNS Administration vs. Treatment as Usual","Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Comparison of taVNS Administration vs. Treatment as Usual","Summary of Adverse Events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["madison-wisconsin"],"enrichment":{"headline":"Phase 1: testing Psilocybin for Healthy","inPlainEnglish":"This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.","whoItsFor":["Ages 18 Years to 70 Years","Ability/willingness to complete all study activities","Modest reduction in emotional well-being","Medically healthy (does not meet criteria for an exclusionary medical condition)","Blood pressure and heart rate within established ranges at screening","Use of acceptable contraceptive methods (sexually active males and women of childbearing potential)"],"whoShouldSkip":["Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)","Current or clinically significant psychiatric disorder that, in the investigator's judgment, would interfere with participation or increase risk","Current use of drugs or medications, prescribed or otherwise, that may interact with psilocybin","Use of investigational drugs, biologics, or devices within 30 days of enrollment","Use of psychedelic or related agents within three months of Dosing Day","Clinically significant electrocardiogram (ECG)","Vitals outside acceptable range"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, Transcutaneous auricular Vagus Nerve Stimulation (taVNS), or Psychosocial Support Alone. The registry lists allocation as randomized. This study will examine whether combining a single dose of psilocybin with non-invasive transcutaneous auricular vagus nerve stimulation (taVNS), a potential inducer of neuroplasticity and enhanced memory formation, will enhance the long-term beneficial behavioral effects of psilocybin when compared to sham taVNS or no VNS by allowing memory for insights gained during the psychedelic experience to remain vivid after they will have faded in subjects who receive psilocybin followed by sham taVNS or no VNS.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 115 people at Madison. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.098Z"},{"nctId":"NCT05866562","title":"Dupilumab in the Treatment of Pediatric Alopecia Areata","officialTitle":"Dupilumab in the Treatment of Pediatric Alopecia Areata","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"This is a prospective, randomized, double-blind, placebo-controlled clinical trial. The study will take place at four sites. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48. All subjects must have evidence of hair regrowth within the last 7 years of their last episode of hair loss; and have screening IgE ≥200 and/or have personal and/or familial history of atopy.\n\nStudy participation will be up to 124 weeks, consisting of: a screening period of up to 4 weeks; a 48-week placebo-controlled period; a 48-week open-label extension period; followed by a 24-week follow-up period.","conditions":["Alopecia Areata"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":76,"startDate":"2024-07-11","completionDate":"2029-03-31","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female participants who are at least 6 years old and under 18 years old, who can provide assent (if appropriate), and for whom signed informed consent can be provided by parent or legal guardian prior to participation in any study assessments or procedures\n\n  \\-- Participant is able to adhere to the study visit schedule and other protocol requirements.\n* Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While on investigational product and for at least 28 days after taking the last dose of investigational product (IP), FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below:\n\n  * Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR\n  * Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]);\n* Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score.\n* Participant has a screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)\n* Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* Participant is pregnant or breastfeeding.\n* Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V).\n* Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss.\n* Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic medications.\n* Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics\n* Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator.\n* Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.\n* Known active hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or positive HIV serology at the time of screening for subjects determined by the investigators to be at high-risk for this disease.\n* Participant has a suspected or active lymphoproliferative disorder or malignancy; OR a history of malignancy within 5 years before the Baseline assessment, except for completely treated in situ non-melanoma skin and cervical cancers without evidence of metastasis.\n* Participant has received a live attenuated vaccine ≤ 28 days prior to study randomization.\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n* History of adverse systemic or allergic reactions to any component of the study drug.\n* Use of systemic immunosuppressive medications, including, but not limited to, cyclosporine, systemic or intralesional corticosteroids, mycophenolate mofetil, azathioprine, methotrexate, tacrolimus, oral JAK inhibitor (tofacitinib, ruxolitinib, baricitinib, ritlecitinib, or investigational oral JAK Inhibitors) or ultraviolet (UV) phototherapy with/without Psoralen Ultraviolet A (PUVA) therapy, within 4 weeks prior to the Week 0/Baseline visit\n* Participant has been previously treated with dupilumab\n* Participant has used topical corticosteroids, and/or tacrolimus, and/or pimecrolimus within 1 week before the Baseline visit.","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University Feinberg School of Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Benjamin Ungar, MD","phone":"212-241-3288","email":"benjamin.ungar@mountsinai.org"}],"primaryOutcomes":["Change in the Severity of Alopecia Tool (SALT) score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["irvine-california","san-diego-california","chicago-illinois","new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Dupilumab for Alopecia Areata","inPlainEnglish":"This is a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial. This trial will enroll a total of 76 children and adolescents with moderate to severe AA (affecting at least 30% of the scalp) at the time of screening with a targeted 61 participants completing through Week 48.","whoItsFor":["Ages 6 Years to 17 Years","\\-- Participant is able to adhere to the study visit schedule and other protocol requirements","Option 1: Any one of the following highly effective methods: hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device (IUD); tubal ligation; or partner's vasectomy; OR","Option 2: Male or female condom (latex condom or non-latex condom NOT made out of natural \\[animal\\] membrane \\[for example, polyurethane\\]);","Participant has a history of at least 6 months of moderate to severe AA (≥ 50% scalp involvement) as measured using the SALT score","Participant has a screening IgE ≥ 200 and/or personal and/or familial history of atopy (including asthma, atopic dermatitis, allergic rhinitis, food allergy, or eosinophilic esophagitis)","Participant is judged to be in otherwise good overall health following a detailed medical and medication history, physical examination, and laboratory testing"],"whoShouldSkip":["Participant is pregnant or breastfeeding","Participant's cause of hair loss is indeterminable and/or they have concomitant causes of alopecia, such traction, cicatricial, pregnancy-related, drug-induced, telogen effluvium, or advanced androgenetic alopecia (i.e. Ludwig Type III or Norwood-Hamilton Stage ≥ V)","Participant has a history of AA with no evidence of hair regrowth for ≥ 7 years since their last episode of hair loss","Severe, uncontrolled asthma (having 2 or exacerbations in the last 12 months that require systemic steroids and/or hospitalization) or a history of life-threatening asthma exacerbations while on appropriate anti-asthmatic medications","Participant has an active bacterial, viral, or helminth parasitic infections; OR a history of ongoing, recurrent severe infections requiring systemic antibiotics","Participant with a known or suspected underlying immunodeficiency or immune-compromised state as determined by the investigator","Participant has a concurrent or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, intestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. This is a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 76 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.710Z"},{"nctId":"NCT05867004","title":"Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma","officialTitle":"Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Institut Claudius Regaud","sponsorClass":"OTHER","summary":"Cutaneous melanoma is a bad prognosis skin cancer, which can be treated with immune checkpoint inhibitors (ICI), such as anti-PD-1 (nivolumab, nivo) and anti-CTLA-4 (ipilimumab, ipi). However, about 50% of patients do not respond or relapse within 3 years post therapy induction, and immune-related adverse events (irAEs), such as colitis, are triggered and can be treated with TNF inhibitor (TNFi; ie, infliximab, inflix). The pharmacodynamic impact of TNFi on the immune and clinical responses remain to be clarified. The investigators previously demonstrated that TNFi enhance the efficacy of ICI in mouse melanoma models. Based on preclinical findings, the investigators implemented two clinical trials in advanced melanoma patients, TICIMEL and MELANFalpha. In TICIMEL, patients are concomitantly treated with TNFi \\[certolizumab (certo) or inflix\\] and ICI (ipi+nivo). In MELANFalpha, patients are treated with ICI alone. Preliminary results show both tritherapies promote systemic MART-1 specific CD8 T cell responses and that certo but not inflix may improve ICI efficacy and Th1 responses. In mouse melanoma models, TNFi enhance the response to ICI. Investigators' primary objective is to decipher how certolizumab and infliximab influence ICI-dependent anti-tumor immune responses in advanced melanoma patients. The secondary objectives are to analyse the cellular and molecular impact anti-TNF have on ICI-dependent anti-melanoma immune responses and clinical activities (irAEs and efficacy). By combining mouse and human data as well ex vivo functional assays, the investigators will dissect the impact treatments have on anti-melanoma immune responses by flow cytometry and transcriptomic analyses. The investigators expect to clarify (i) the mechanisms by which TNFi enhance ICI efficacy, (ii) identify the best TNFi to be combined with ICI in advanced melanoma patients and (iii) discover TNF-dependent biomarkers of resistance.","conditions":["Melanoma","Immune Defect","Tumor Skin"],"keywords":["Melanoma","Immune checkpoint inhibitors","TNF","Resistance"],"interventions":[],"enrollment":100,"startDate":"2023-01-01","completionDate":"2027-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion in TICIMEL clinical trial (NCT03293784),\n* Inclusion in MELANFα trial (NCT03348891)\n\nExclusion Criteria:\n\n* NA","locations":[{"facility":"Institut Claudius Regaud","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bruno SEGUI, Pr","phone":"+33 (0)5 82 74 16 21","email":"bruno.segui@inserm.fr"}],"primaryOutcomes":["To decipher how certolizumab and infliximab influence the ICI-dependent systemic immune responses in advanced melanoma patients"],"hasResults":false,"conditionSlugs":["melanoma","als"],"drugSlugs":["nivolumab"],"locationSlugs":["toulouse-france"],"enrichment":{"headline":"Blocking TNF to Potentiate the ICI-dependent Immune Awakening in Melanoma","inPlainEnglish":"Cutaneous melanoma is a bad prognosis skin cancer, which can be treated with immune checkpoint inhibitors (ICI), such as anti-PD-1 (nivolumab, nivo) and anti-CTLA-4 (ipilimumab, ipi). However, about 50% of patients do not respond or relapse within 3 years post therapy induction, and immune-related side effects (irAEs), such as colitis, are triggered and can be treated with TNF inhibitor (TNFi; ie, infliximab, inflix).","whoItsFor":["Ages 18 Years to any","Inclusion in TICIMEL clinical trial (NCT03293784),","Inclusion in MELANFα trial (NCT03348891)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Toulouse. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.801Z"},{"nctId":"NCT05867251","title":"Study of AVZO-021 in Patients With Advanced Solid Tumors","officialTitle":"A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-021 as a Single Agent and in Combination Therapy in Patients With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Avenzo Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).","conditions":["Advanced Solid Tumor","HR+/HER2- Breast Cancer","HR+, HER2-, Advanced Breast Cancer","CCNE1 Amplification","Epithelial Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer","TNBC - Triple-Negative Breast Cancer"],"keywords":["Advanced solid tumor","HR+/HER2- Breast Cancer","Breast Cancer","Advanced Breast Cancer","CCNE1 Amplification","Epithelial Ovarian Cancer","Primary Peritoneal Cancer","Fallopian Tube Cancer","Endometrial Cancer","Triple Negative Breast Cancer"],"interventions":[{"type":"DRUG","name":"AVZO-021"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Sacituzumab Govitecan-hziy"}],"enrollment":430,"startDate":"2023-08-30","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1.\n2. Disease-related inclusion criteria by study phase and part:\n\n   i) Phase 1a Monotherapy Dose Escalation: Patients with locally advanced or metastatic HR+/HER2- breast cancer, CCNE1-amplified tumors that are either epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor. Patients with any additional tumor type with CCNE1 amplification can be enrolled only if clinical data is supportive and approved by medical monitor (Cohort 1A).\n\n   ii) Phase 1b Combination Dose Escalation: histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+ HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer, who have been previously treated with inhibitor of CDK4/6 and endocrine therapy(Cohorts 1B1, 1B2, 1B3, 1B4, and 1B5); or histologically or cytologically confirmed diagnosis of CCNE1- amplified, locally advanced or metastatic, platinum-refractory or platinum-resistant EOC, primary peritoneal, or fallopian tube cancer (Cohort 1C).\n\n   iii) Phase 2a Monotherapy dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic CCNE1 amplified epithelial ovarian cancer, primary peritoneal cancer, fallopian tube cancer, endometrial cancer or TNBC, with no other oncogenic driver mutations that are treatable and standard therapies are no longer effective, appropriate, or safe in the opinion of the investigator and medical monitor (Cohort 2A).\n\n   iv) Phase 2b Combination dose expansion: Histologically or cytologically confirmed diagnosis of locally advanced or metastatic HR+/HER2- (HER2-low may be allowed if failed standard of care therapy) breast cancer who have been previously treated with no more than 1 prior CDK4/6 inhibitor and endocrine therapy (Cohorts 2B1, 2B2, 2B3, 2B4, and 2B5); or Histologically or cytologically confirmed diagnosis of locally advanced or metastatic, CCNE1-amplified, platinum-refractory or platinum-resistant EOC, primary peritoneal cancer, or fallopian tube cancer (Cohort 2C).\n3. No more than 2 prior cytotoxic chemotherapy regimens for locally advanced/metastatic disease (excepting patients treated with an antibody-drug conjugate, with ovarian cancer if there disease is platinum resistant or refractory, having progressed beyond all SOC care; and patients who have received prior chemotherapy in the adjuvant or neoadjuvant setting \\>12 months prior to starting AVZO-021 treatment).\n4. Measurable disease as determined by RECIST version 1.1.\n5. Adequate bone marrow and organ function.\n6. Ability to swallow capsules or tablets.\n\nKey Exclusion Criteria:\n\n1. Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021.\n2. Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted.\n3. Undergone major surgery within 4 weeks prior to planned start of AVZO-021.\n4. Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol.\n5. Active CNS metastases or confirmed leptomeningeal disease are not eligible.\n6. Unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment.\n7. Clinically unstable cardiac function as described in the protocol.\n8. Any active or chronic infection/disease that compromises the immune system.\n9. Current treatment with strong or moderate cytochrome P450 (CYP)3A4 inhibitors or inducers.\n10. Active second malignancy unless in remission with life expectancy \\> 2 years and with documented sponsor approval.\n11. Pregnancy, lactation, or plans to breastfeed during the study or within 6 months of the last dose of study intervention.","locations":[{"facility":"Avenzo Therapeutics Recruiting Site","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Macquarie University","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenzo Therapeutics Recruiting Site","city":"Wollongong","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical Information","phone":"(858) 239-2944","email":"ClinicalTrials@avenzotx.com"}],"primaryOutcomes":["Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)","Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)","Determination of Recommended Phase 2 Dose (RP2D) (Phase 1)","Objective Response Rate (ORR) (Phase 2)","Progression Free Survival (PFS) (Phase 2)","Overall Survival (OS) (Phase 2)","Duration of response (DOR) (Phase 2)"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer","endometrial-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["new-haven-connecticut","sarasota-florida","tampa-florida","mineola-new-york","new-york-new-york","cleveland-ohio","oklahoma-city-oklahoma","portland-oregon","philadelphia-pennsylvania","dallas-texas","fairfax-virginia","macquarie-university-australia","wollongong-australia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing AVZO-021 for Advanced Solid Tumor","inPlainEnglish":"This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors. AVZO-021 is an oral medication that inhibits cyclin-dependent kinase 2 (CDK 2).","whoItsFor":["Ages 18 Years to any","Male or female aged ≥18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1","Disease-related who can join by study phase and part:","Measurable disease as determined by RECIST version 1.1","Adequate bone marrow and organ function","Ability to swallow capsules or tablets"],"whoShouldSkip":["Received an investigational agent or anticancer therapy within 2 weeks, or 5 half-lives of the drug, whichever is shorter, prior to planned start of AVZO-021","Received any CDK2 inhibitor, protein kinase membrane associated tyrosine/threonine 1 (PKMYT1) inhibitor, or WEE1 inhibitor anticancer therapy. For cohort B5, prior therapy with topoisomerase inhibitors is not permitted","Undergone major surgery within 4 weeks prior to planned start of AVZO-021","Received radiotherapy for palliation within 7 days of the first dose of study treatment, unless specified otherwise in the protocol","Active CNS metastases or confirmed leptomeningeal disease are not eligible","Unresolved toxicities from prior therapy greater than Common Terminology Criteria for side effects (CTCAE) version 5.0 Grade \\>1 at the time of starting study treatment","Clinically unstable cardiac function as described in the protocol"],"whatHappens":"If you join, the listed intervention(s) are AVZO-021, Palbociclib, or Fulvestrant. The registry lists allocation as randomized. This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 430 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.723Z"},{"nctId":"NCT05877885","title":"Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics","officialTitle":"Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"AdventHealth","sponsorClass":"OTHER","summary":"The goal of this randomized controlled trial is to evaluate the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.","conditions":["Major Depressive Disorder","Apathy"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Targeted Cognitive Training Intervention"},{"type":"BEHAVIORAL","name":"General Cognitive Training Intervention"}],"enrollment":84,"startDate":"2025-09-19","completionDate":"2028-11-01","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 60+ years\n2. Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview\n3. Montgomery-Åsberg Depression Rating Scale (MADRS) score \\> or = 16.\n4. Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES \\> or = to 37)\n5. Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks.\n6. On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks.\n7. Capacity to provide written consent for research assessment and treatment\n8. Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff.\n9. Total score of \\> 29 on the Telephone Interview for Cognitive Status (TICS)\n10. Eligible to undergo MRI\n11. Access to a computer or tablet with Wifi capabilities\n12. Able to comply with all testing and study requirements and willingness to participate in the full study duration.\n\nExclusion Criteria:\n\n1. History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia\n2. Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments.\n3. Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy).\n4. Any other acute medical condition (e.g., cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease; metastatic cancer; or debilitated states or less common medical illnesses) that may influence brain systems of interest or interfere with participation or interpretation of the study results.\n5. Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior.\n6. Electroconvulsive therapy within the past 12 months\n7. Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder.\n8. Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)\n9. Claustrophobia\n10. Color Blindness\n11. Sensory or physical impairment that would preclude cognitive testing or participation in the intervention (e.g., upper limb paralysis) as reported by the participant or observed by the Investigator.\n12. Travelling consecutively for 2+ weeks during the study period to a location that will preclude timely collection of post-treatment MRI data.\n13. Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, cochlear implant, any other metallic biomedical implant contraindicating to MRI.","locations":[{"facility":"AdventHealth Neuroscience Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lauren Oberlin, PhD","phone":"(860) 690-8441","email":"lauren.oberlin@adventhealth.com"}],"primaryOutcomes":["Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["orlando-florida"],"enrichment":{"headline":"Not a traditional drug phase: Targeted Cognitive Training Intervention for Major Depressive Disorder","inPlainEnglish":"The goal of this randomly assigned controlled trial is to measure the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits. The investigators hypothesize that 4 weeks of a customized digital cognitive training program will lead to changes in brain connectivity, apathy severity, and cognitive control performance.","whoItsFor":["Ages 60 Years to any","Diagnosis of unipolar major depressive disorder without psychotic features, as assessed by the Mini International Neuropsychiatric Interview","Montgomery-Åsberg Depression Rating Scale (MADRS) score \\> or = 16","Clinically significant apathy, determined by the Clinician-rated Apathy Evaluation Scale (C-AES \\> or = to 37)","Off antidepressants or on a stable dose of an antidepressant for 8 weeks and do not intend to change the dose in the next 5 weeks","On a stable dose of other psychotropic medications, deemed by the investigator to be associated with brain networks of interest, for at least 8 weeks","Capacity to provide written consent for research assessment and treatment","Ability to follow written and verbal instructions (English) as assessed by the PI and/or study staff"],"whoShouldSkip":["History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, persistent depressive disorder, generalized anxiety disorder, social anxiety disorder, or specific phobia","Use of cholinesterase inhibitors or psychoactive drugs other than antidepressants or benzodiazepines, including antipsychotics, that in the opinion of the Investigator may confound study data/assessments","Presence or history of significant neurologic or neurodegenerative disorder (e.g., Alzheimer's disease and other dementias, amnestic Mild Cognitive Impairment, history of stroke, Multiple Sclerosis, Parkinson's disease, epilepsy)","Participant is currently considered at risk for attempting suicide by the Investigator, has made a suicide attempt within the past year, or is currently demonstrating active suicidal ideation or self-injurious behavior","Electroconvulsive therapy within the past 12 months","Recent history (within 6 months prior to screening/baseline) of Substance Use Disorder","Participant is currently enrolled in ongoing concurrent cognitive rehabilitation (note that if a subject is enrolled in psychotherapy, this will not be grounds for exclusion)"],"whatHappens":"If you join, the listed intervention(s) are Targeted Cognitive Training Intervention, or General Cognitive Training Intervention. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to measure the potential of a customized digital cognitive training intervention to target aspects of brain function in apathy of late-life depression and reduce symptoms of apathy and related cognitive and behavioral deficits.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 84 people at Orlando. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.109Z"},{"nctId":"NCT05884190","title":"Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension","officialTitle":"Community-based, Family-centered, Trauma-informed Approach to Timely Detection and Management of Early Postpartum Hypertension","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications. The investigators will accomplish this by comparing the effectiveness of two multi-component multi-level healthcare delivery models focused on early detection and control of postpartum hypertension and the social and mental health factors known to impact maternal outcomes, with the current standard of care and with each other.","conditions":["Postpartum Hypertension"],"keywords":[],"interventions":[{"type":"OTHER","name":"Remote Medical Model (RMM)"},{"type":"OTHER","name":"Community Health Model (CHM)"},{"type":"OTHER","name":"SoC"}],"enrollment":6030,"startDate":"2023-06-12","completionDate":"2027-10-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify)\n* Postpartum\n* English or Spanish speaking\n* Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate)\n* Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured\n* Must living in one of the three states involved in this study (Connecticut, Massachusetts, New York) and preferably within the geographical area of each of the hospitals\n\nExclusion Criteria:\n\n* Multifetal pregnancy (since are they at increased risk for key outcomes)\n* Gestational age \\<24 weeks;\n* Known major fetal anomaly in current pregnancy or stillbirth\n* Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes\n* Active suicidal ideation with intent and plan\n* Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)\n* Plans to move out of the state within 6 months\n* Incapable of consent\n* Severe medical complications that don't allow a mother to do the study effectively (for example, active treatment for cancer, dialysis etc. )\n* Physician or provider refusal\n* Patient refusal\n* Incarcerated or institutionalized\n* Stillbirth\n\nBirths that result in the newborn being under the care of another person or institution other than the birthing individual (e.g. adoption, state involvement) will be evaluated on an individual basis to determine if that person should be included.\n\nFor participants without access to a phone, we will explore if there are options that will allow them to have access to a devise for the times when they need to communicate with the study team. If not, they will not be able to participate in the study since this study requires phone or telehealth communication with research staff and/or APPs, and CHWs depending on study phase.","locations":[{"facility":"Yale New Haven Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Massachusetts Memorial Health","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oishei Children's Hospital University at Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rafael Pérez-Escamilla, PhD","phone":"8608052502","email":"rafael.perez-escamilla@yale.edu"}],"primaryOutcomes":["Change in mean postpartum systolic blood pressure (SBP) at 6 weeks","Depression severity at 3 months postpartum assessed using the Edinburgh Postnatal Depression Scale (EPDS)."],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","worcester-massachusetts","buffalo-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Remote Medical Model (RMM) for Postpartum Hypertension","inPlainEnglish":"The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications. The investigators will accomplish this by comparing the effectiveness of two multi-component multi-level healthcare delivery models focused on early detection and control of postpartum hypertension and the social and mental health factors known to impact maternal outcomes, with the current standard of care and with each other.","whoItsFor":["Ages 18 Years to any","Women only","Delivery of singleton live birth (twins reduced to singleton or with vanishing twin syndrome prior to 14 weeks qualify)","English or Spanish speaking","Viable pregnancy 24 weeks of gestation or above (Child can be in NICU to participate)","Medicaid or the equivalent within each state (for example, Connecticut has Husky insurance) or uninsured","Must living in one of the three states involved in this study (Connecticut, Massachusetts, New York) and preferably within the geographical area of each of the hospitals"],"whoShouldSkip":["Multifetal pregnancy (since are they at increased risk for key outcomes)","Gestational age \\<24 weeks;","Known major fetal anomaly in current pregnancy or stillbirth","Actively using illicit/illegal substances (such as cocaine, heroin and other types of illicit opiates such as fentanyl) as noted in delivery hospitalization notes","Active suicidal ideation with intent and plan","Known primary psychotic disorder (i.e. schizophrenia, or schizoaffective disorder)","Plans to move out of the state within 6 months"],"whatHappens":"If you join, the listed intervention(s) are Remote Medical Model (RMM), Community Health Model (CHM), or SoC. The registry lists allocation as randomized. The investigators primary project goal is to improve clinical outcomes, including mental health outcomes, among postpartum at-risk women experiencing health disparities by increasing awareness, detection, and timely care of postpartum hypertension, mental health and cardiovascular complications.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 6,030 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.043Z"},{"nctId":"NCT05897320","title":"A Study of Eptinezumab in Pediatric Participants With Episodic Migraine","officialTitle":"Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"H. Lundbeck A/S","sponsorClass":"INDUSTRY","summary":"The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.","conditions":["Episodic Migraine"],"keywords":[],"interventions":[{"type":"DRUG","name":"Eptinezumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":315,"startDate":"2023-06-08","completionDate":"2027-07-06","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit.\n* During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit.\n* During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary.\n\nExclusion Criteria:\n\n* History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., \\>60 min).\n* History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system.\n* Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded.\n* Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance.\n\nOther inclusion and exclusion criteria may apply.","locations":[{"facility":"New England Institute for Clinical Research (NEICR) - Stamford","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Child Neurology Center (CNC) of Northwest Florida","city":"Gulf Breeze","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AGA Clinical Trials","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida (USF) - Tampa Campus","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta (CIRCAtl)","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UK HealthCare-Kentucky Clinic","city":"Lexington","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Maryland School of Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Michigan Headache & Neurological Institute (MHNI)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"True North Neurology - Commack (North Suffolk Neurology)","city":"Commack","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"OnSite Clinical Solutions, LLC - Charlotte","city":"Charlotte","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Akron Children's Hospital","city":"Akron","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center-Burnet Campus","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Road Runner Research (RRR)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Specialty Group (CSG)","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Wisconsin (Children's Hospital of Wisconsin)-Main Campus","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mautalén Salud e Investigación","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital de Niños de la Santísima Trinidad","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Río Cuarto","city":"Río Cuarto","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"INECO Neurociencias Oroño","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Medicas Tucuman","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Independencia","city":"Buenos Aires","state":"","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Britanico de Buenos Aires (HOB)","city":"Buenos Aires","state":"","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Medical Arts Health Research Group - Penticton","city":"Penticton","state":"British Columbia","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Vancouver Island Health Authority (VIHA) - Multiple Sclerosis (MS) Clinic","city":"Victoria","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kids Clinic","city":"Ajax","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre (LHSC)","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"L'Azienda Ospedaliera Brotzu - Clinica di Neuropsichiatria dell'Infanzia e dell'Adolescenza - Ret...","city":"Cagliari","state":"South Sardinia","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Istituto Giannina Gaslini (Ospedale Pediatrico IRCCS) - Centro Malattie Rare","city":"Genoa","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","city":"Milan","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Fondazione Mondino, IRCCS Istituto Neurologico Nazionale a Carattere Scientifico","city":"Pavia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara - Istituto To...","city":"Pisa","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu - Gianicolo","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigacion Clinica de Morelia, S.C.","city":"Morelia","state":"Michoacán","country":"Mexico","status":"COMPLETED","lat":null,"lon":null},{"facility":"Clinical Research Institute SC-Mexico","city":"Tepetlacolco","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Plejady","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instytut Zdrowia dr Boczarska-Jedynak Sp. z o.o. Sp. k","city":"Oświęcim","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Lublin","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MTZ Clinical Research Powered by PRATIA","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"European Trial group network Sp. z o.o - Neuroscience","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Braga","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Pediátrico de Coimbra","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital CUF Descobertas, S.A.","city":"Lisbon","state":"","country":"Portugal","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centro Hospitalar Universitario de Santo Antonio - Centro Materno Infantil do Norte (CMIN)","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Hospitalar Universitario de Sao Joao (CHUSJ)","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univerzitetska Decija Klinika (UDK) (University Children's Hospital)","city":"Belgrade","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Novi Sad - Faculty of Medicine - Clinical Center of Vojvodina - Hematology Clinic","city":"Novi Sad","state":"Juznobacki Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Child and Youth Health Care of Vojvodina","city":"Novi Sad","state":"Juznobacki Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Center Kragujevac","city":"Kragujevac","state":"Sumadijski Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Nis","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complexo Hospitalario Universitario de Vigo-Hospital Alvaro Cunqueiro (HAC)","city":"Vigo","state":"Pontevedra","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi (Eskisehir Osmangazi University Hospital)","city":"Eskişehir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Universitesi - Istanbul Tip Fakultesi (ITF) Hastanesi","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"İzmir Şehir Hastanesi","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mersin Universitesi-Tip Fakultesi","city":"Mersin","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHS Lothian - Royal Hospital for Children & Young People (RHCYP)","city":"Edinburgh","state":"Eastern Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Paget University Hospitals NHS Foundation Trust","city":"Great Yarmouth","state":"Norfolk","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHS Greater Glasgow and Clyde (NHSGGC) - Royal Hospital for Children - Glasgow (Royal Hospital fo...","city":"Glasgow","state":"South Western Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital for Children NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Email contact via H. Lundbeck A/S","phone":"+45 36301311","email":"HQ_Medinfo@Lundbeck.com"}],"primaryOutcomes":["Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["stamford-connecticut","gulf-breeze-florida","hialeah-florida","tampa-florida","atlanta-georgia","lexington-kentucky","baltimore-maryland","ann-arbor-michigan","commack-new-york","charlotte-north-carolina","akron-ohio","cincinnati-ohio","san-antonio-texas","norfolk-virginia","milwaukee-wisconsin","buenos-aires-argentina","c-rdoba-argentina","r-o-cuarto-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","penticton-canada","victoria-canada","ajax-canada","london-canada","cagliari-italy","genoa-italy","milan-italy","pavia-italy","pisa-italy","rome-italy","morelia-mexico","tepetlacolco-mexico","krakow-poland","o-wi-cim-poland","lublin-poland","warsaw-poland","braga-portugal","coimbra-portugal","lisbon-portugal","porto-portugal","belgrade-serbia","novi-sad-serbia","kragujevac-serbia","ni-serbia","vigo-spain","barcelona-spain","madrid-spain","eski-ehir-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","mersin-turkey-t-rkiye","edinburgh-united-kingdom","great-yarmouth-united-kingdom","glasgow-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Eptinezumab for Episodic Migraine","inPlainEnglish":"The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.","whoItsFor":["Ages 6 Years to 17 Years","Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit","During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (≥23 of the 28 days) following the day of the Screening Visit","During the 28-day screening period, the participant must have ≤14 headache days, of which at least 4 are migraine days as documented in the eDiary"],"whoShouldSkip":["History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system","Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded","Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance","Other inclusion and"],"whatHappens":"If you join, the listed intervention(s) are Eptinezumab, or Placebo. The registry lists allocation as randomized. The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 315 people at 60 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.305Z"},{"nctId":"NCT05904093","title":"Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease","officialTitle":"A Phase I Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nSickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal (\"sickled\") red blood cells. SCD can cause anemia and life-threatening complications in the lungs, heart, kidney, and nerves. People with SCD are also at increased risk of forming blood clots in the veins and lungs, but the standard treatments for these clots can cause increased bleeding in people with SCD. Better treatments are needed.\n\nObjective:\n\nTo test a drug (fostamatinib) in people with SCD.\n\nEligibility:\n\nPeople aged 18 to 65 with SCD.\n\nDesign:\n\nParticipants will have 6 clinic visits over 12 weeks. Each visit will be 2 to 3 hours.\n\nParticipants will be screened. They will have a physical exam with blood tests. They will tell the researchers about the medications they take.\n\nFostamatinib is a tablet taken by mouth. Participants will take the drug at home, twice a day, for up to 6 weeks.\n\nParticipants will have a clinic visit every 2 weeks while they are taking the drug. At each visit they will have a physical exam with blood tests. They will talk about any side effects the drug may be causing. If they are tolerating the drug well after the first 2 weeks, they may begin taking a higher dose.\n\nParticipants will have a final visit 4 weeks after they stop taking the drug. They will have a physical exam and blood tests; they will be checked for any side effects of the drug.","conditions":["Sickle Cell Disorders","Sickle Cell Disease","Hemoglobin S","Hb-SS Disease","Disease Sickle Cell Anemia"],"keywords":["Sickle Cell","Tyrosine Kinase Inhibitor","Fostamatinib"],"interventions":[{"type":"DRUG","name":"Fostamatinib"}],"enrollment":35,"startDate":"2024-12-18","completionDate":"2027-05-14","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nSubjects will enroll onto the study and undergo screening. Subjects who do not meet any of the following criteria during screening will not receive the study intervention but will be counted toward study accrual. Screen failures may be rescreened at a later time. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Have provided signed written informed consent prior to performing any study procedure, including screening procedures.\n2. Age between 18-65 years\n3. Unequivocal diagnosis of SCA (HbSS or HbSBeta\\^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused.\n4. No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)\n5. Have adequate organ function, as defined by:\n\n   1. Serum aspartate aminotransferase (AST) \\<=1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\<=1.5 x ULN.\n   2. Absolute neutrophil count \\>=1.5 x 10\\^9/L.\n   3. Hemoglobin \\>= 7 g/dL\n   4. Platelet count \\>=100 x 10\\^9/L.\n6. If on hydroxyurea, participant must have been on stable dose of hydroxyurea (defined as a stable dose for at least 3 months and inclusive of dose modifications for hematological toxicity per PI discretion) prior to signing consent.\n7. For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).\n8. For women of reproductive potential as well as men and their partners who are women of reproductive potential, be abstinent as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 28 days (both men and women) following the last dose of study treatment. An effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine or subdermal contraceptive implants, and barrier methods.\n9. Be willing to comply with all study procedures for the duration of the study.\n10. Must be able to provide consent\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pain crisis requiring parenteral treatment within 14 days of signing consent.\n2. Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:\n\n   1. History of neutropenia (benign ethnic neutropenia and/or acquired neutropenia related to drug suppression by hydroxyurea and/or cyclic hematopoiesis are permitted).\n   2. History of posterior reversible encephalopathy syndrome (PRES)\n   3. History of poorly controlled hypertension (defined as systolic blood pressure \\>=130 mmHg or average diastolic blood pressure \\>=90 mmHg based on an average of 3 blood pressure readings despite adequate antihypertensive therapy) unless controlled for \\>90 days prior to enrollment.\n   4. Active viral infection as evidenced by testing positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (ab) with signs of active hepatitis B or C virus infection. If the subject is positive for HCV Ab, a reverse transcriptase-polymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.\n   5. History of drug-induced cholestatic hepatitis.\n   6. History of any primary malignancy.\n   7. Testing positive for human immunodeficiency virus 1 or 2 Ab with evidence for ongoing active infection (i.e., CD 4 count \\<400/microliter and viral load \\>100,000 copies/ml) on antiretroviral therapy.\n   8. Current or recent history of psychiatric disorder that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.\n   9. Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.\n   10. Use of newly approved SCD therapy (L-glutamine or crizanlizumab) is NOT permitted on this study. Subjects who have received newly approved SCD therapy in the 7 days prior to signing consent will be excluded.\n   11. Having had a prior bone marrow or stem cell transplant.\n   12. Currently pregnant or lactating.\n   13. Currently receiving strong inhibitors of CYP3A4/5 that have not been stopped for \\>=5 days or a time frame equivalent to 5 half-lives (whichever is longer), or strong inducers of CYP3A4 that have not been stopped for \\>=28 days or a time frame equivalent to 5 half-lives (whichever is longer), prior to signing consent. SCD patients that are receiving treatment with CYP3A4 substrate drugs, some BCRP substrate drugs (eg. rosuvastatin), and some P-glycoprotein substrate drugs (eg. Digoxin) are excluded from the study.\n   14. Currently receiving erythropoiesis stimulating agents.\n3. Has received fostamatinib in 3 months prior to signing consent","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jordan B Branch","phone":"(301) 221-3820","email":"jordan.branch@nih.gov"},{"name":"Swee Lay Thein, M.D.","phone":"(301) 435-2345","email":"sweelay.thein@nih.gov"}],"primaryOutcomes":["Safety and tolerability of fostamatinib"],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Fostamatinib for Sickle Cell Disorders","inPlainEnglish":"Background: Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal (\"sickled\") red blood cells. SCD can cause anemia and life-threatening complications in the lungs, heart, kidney, and nerves.","whoItsFor":["Ages 18 Years to 65 Years","Age between 18-65 years","Unequivocal diagnosis of SCA (HbSS or HbSBeta\\^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused","No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)","Have adequate organ function, as defined by:","Serum aspartate aminotransferase (AST) \\<=1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\<=1.5 x ULN","Absolute neutrophil count \\>=1.5 x 10\\^9/L","Hemoglobin \\>= 7 g/dL"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Pain crisis requiring parenteral treatment within 14 days of signing consent","Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:","History of neutropenia (benign ethnic neutropenia and/or acquired neutropenia related to drug suppression by hydroxyurea and/or cyclic hematopoiesis are permitted)","History of posterior reversible encephalopathy syndrome (PRES)","History of drug-induced cholestatic hepatitis","History of any primary malignancy"],"whatHappens":"If you join, the listed intervention(s) are Fostamatinib. The registry lists allocation as na. Background: Sickle cell disease (SCD) is a genetic disease that causes the body to produce abnormal (\"sickled\") red blood cells.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 35 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.834Z"},{"nctId":"NCT05906992","title":"A Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis","officialTitle":"A Double-blind, Randomized, Active-controlled, Parallel Group, Phase 1/3 Study to Compare Efficacy, Pharmacokinetics, Pharmacodynamics and Safety of CT-P53 and Ocrevus in Patients With Relapsing-remitting Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Celltrion","sponsorClass":"INDUSTRY","summary":"This is a double-blind, randomized, active-controlled, parallel group, Phase 1/3 study to compare efficacy, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.","conditions":["Relapsing-remitting Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"CT-P53"},{"type":"BIOLOGICAL","name":"US-Ocrevus"},{"type":"BIOLOGICAL","name":"EU-Ocrevus"}],"enrollment":512,"startDate":"2024-01-11","completionDate":"2027-02","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria.\n* Patient has evidence of recent MS activity as defined in the study protocol\n* Patient has neurological stability for ≥30 days.\n* Patient with 0 to 6.0 (both inclusive) on the EDSS score.\n\nExclusion Criteria:\n\n* Patient diagnosed with primary or secondary progressive MS.\n* Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening.\n* Patient unable to complete or has a contraindication to an MRI\n* Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol.\n* Patient who has currently or history of any of medical conditions described in the study protocol.\n* Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol.","locations":[{"facility":"CT-P53 3.1 investigational site","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"SoYoung Yoo","phone":"+82 32 850 5791","email":"soyoung.yoo@celltrion.com"},{"name":"JinHo Lee","phone":"+82 32 850 5787","email":"jinho.lee2@celltrion.com"}],"primaryOutcomes":["Area under the concentration-time curve in PK group","Total number of new GdE lesions on T1-weighted brain MRI in Main study group"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Phase 3: testing CT-P53 for Relapsing-remitting Multiple Sclerosis","inPlainEnglish":"This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, active-controlled, parallel group, Phase 1/3 study to compare how well it works, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.","whoItsFor":["Ages 18 Years to 55 Years","Patient diagnosed as multiple sclerosis (MS) in accordance with the revised McDonald criteria","Patient has evidence of recent MS activity as defined in the study protocol","Patient has neurological stability for ≥30 days","Patient with 0 to 6.0 (both inclusive) on the EDSS score"],"whoShouldSkip":["Patient diagnosed with primary or secondary progressive MS","Patient diagnosed with MS for more than 15 years duration with an EDSS score ≤2.0 at Screening","Patient unable to complete or has a contraindication to an MRI","Patient with contraindications and/or severe hypersensitivity to corticosteroids including methylprednisolone or any of the excipients of study drug or etcs defined in the study protocol","Patient who has currently or history of any of medical conditions described in the study protocol","Patients who have received or going to receive any of prohibited medications or treatments defined in the study protocol"],"whatHappens":"If you join, the listed intervention(s) are CT-P53, US-Ocrevus, or EU-Ocrevus. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, active-controlled, parallel group, Phase 1/3 study to compare how well it works, PK, PD and overall safety of CT-P53 with Ocrevus in patients with Relapsing-remitting Multiple Sclerosis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 512 people at Poznan. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.997Z"},{"nctId":"NCT05907655","title":"Study of the Glymphatic System in Migraine","officialTitle":"Discovering the Functional Role of the Glymphatic System in the Genesis of the Migraine Attack","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS San Raffaele","sponsorClass":"OTHER","summary":"This study aimed to investigate the role of the glymphatic system in the initiation of migraine attacks, using non-invasive magnetic resonance imaging techniques and a validated model of migraine induction by nitroglycerin administration. Secondarily, the relationship between the function of the glymphatic system during nitroglycerin-induced migraine attacks and sleep architecture and plasma levels of migraine-involved neuropeptides will be investigated.","conditions":["Migraine"],"keywords":["migraine","MRI","glymphatic system","sleep","neuropeptides"],"interventions":[{"type":"DRUG","name":"Nitroglycerin 0.3 MG"},{"type":"DIAGNOSTIC_TEST","name":"MRI"},{"type":"DIAGNOSTIC_TEST","name":"Blood sampling"},{"type":"DEVICE","name":"Sleep profiler"}],"enrollment":50,"startDate":"2023-04-30","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nFor patients:\n\n• Diagnosis of migraine, by the ICHD-3 criteria;\n\nFor both patients and healthy controls:\n\n* Age between 18 and 60 years;\n* Willing and able to comply with scheduled visits.\n\nExclusion criteria\n\nFor patients:\n\n* Overuse of acute medications for headache;\n* Continuous or daily headache;\n* Other primary headache disorders, with the exception of infrequent tension-type headache.\n\nFor healthy controls:\n\n• Any subject with frequent tension type headache, migraine, cluster headache, other pain syndromes or neurological conditions.\n\nFor both patients and healthy controls:\n\n* Allergy to nitroglycerin;\n* Major psychiatric disorders such as bipolar affective disorder and schizophrenia;\n* Cardiovascular diseases that contraindicated the use of nitroglycerin;\n* Intracranial hypertension;\n* Cerebral haemorrhage;\n* Cerebral trauma;\n* Pulmonary toxic oedema;\n* Closed angle glaucoma;\n* Anaemia;\n* Pregnancy and breastfeeding;\n* Aortic stenosis or significant hypotension (SBP\\<90mmHg or \\<100mmHg and symptomatic) precluding nitroglycerin administration;\n* Use of sildenafil;\n* Any person unable to lie still within the environment of the MRI scanner for the required period to perform the study;\n* Any person where MRI scanning is contraindicated (metal implants, pacemaker, claustrophobia, etc.);\n* Use of illicit drugs;\n* MRI head showing any brain pathology, such as space-occupying lesions;\n* Any person unable to understand and follow the instructions of the investigators.","locations":[{"facility":"IRCCS San Raffaele Hospital","city":"Milan","state":"Milan","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Roberta Messina, MD, PhD","phone":"00390226433944","email":"messina.roberta@hsr.it"}],"primaryOutcomes":["Change from baseline glymphatic function after nitroglycerin administration"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: testing Nitroglycerin 0.3 MG for Migraine","inPlainEnglish":"This study aimed to investigate the role of the glymphatic system in the initiation of migraine attacks, using non-invasive magnetic resonance imaging techniques and a validated model of migraine induction by nitroglycerin administration. Secondarily, the relationship between the function of the glymphatic system during nitroglycerin-induced migraine attacks and sleep architecture and plasma levels of migraine-involved neuropeptides will be investigated.","whoItsFor":["Ages 18 Years to 60 Years","Diagnosis of migraine, by the ICHD-3 criteria;","For both patients and healthy controls:","Age between 18 and 60 years;","Willing and able to comply with scheduled visits"],"whoShouldSkip":["Overuse of acute medications for headache;","Continuous or daily headache;","Other primary headache disorders, with the exception of infrequent tension-type headache","For healthy controls:","Any subject with frequent tension type headache, migraine, cluster headache, other pain syndromes or neurological conditions","For both patients and healthy controls:","Allergy to nitroglycerin;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at Milan. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.290Z"},{"nctId":"NCT05911529","title":"Tracking the Linguistic Signatures of Motivational Interviewing in Acute Psychosis","officialTitle":"Tracking the Linguistic Signatures of Motivational Interviewing in Acute Psychosis (Former: Motivational Interviewing for Patients With Acute Psychosis)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Psychiatric University Hospital, Zurich","sponsorClass":"OTHER","summary":"Psychotic disorders are associated with high levels of distress, limitations in quality of life, and a high risk of chronification for those affected. The treatment guidelines recommend combining the pharmacological treatment with psychotherapeutic methods, starting already in the acute phase. At the same time, there is little research evidence on which mechanisms of psychotherapy are most effective and best feasible for the acute setting. Therefore, the aim is to run a pilot study to test specific psychotherapeutic interventions for patients with psychosis on acute psychiatric wards.\n\nThe method of \"Motivational Interviewing\" is a well-known and established interviewing technique, which originally comes from the treatment of addictive disorders. In this study, it is used to strengthen the therapeutic alliance between patient and practitioner already in the acute phase of the disease, to increase adherence, and thus to achieve the overall goal of better integrating patients with pronounced positive symptoms into treatment. This appears to be extremely important, as non-adherence represents one of the greatest risks for chronification of the disease. The intervention will subsequently be evaluated in comparison to \"treatment as usual\".","conditions":["Psychosis","Schizophrenia"],"keywords":["Psychosis","Motivational Interviewing","Psychotherapy for psychosis","Adherence to treatment","Therapeutic alliance","Acute phase"],"interventions":[{"type":"BEHAVIORAL","name":"Motivational Interviewing"},{"type":"BEHAVIORAL","name":"Psychoeducation"}],"enrollment":128,"startDate":"2023-03-15","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Informed consent as documented by signature\n* Male and female patients from inpatient units of the Psychiatric University Hospital of Zurich\n* ICD-10 diagnosis of a mental disorder with psychotic symptoms, including schizophrenia, schizotypal and delusional disorders (F20-F29), affective disorders with psychotic features (F30.2, F31.2, F31.5, F32.3, F33.3) and substance-induced psychotic disorders (F1x.5)\n* Fluent in German and able to understand the instructions\n\nExclusion Criteria:\n\n* Organic schizophrenia-like disorder (ICD: F0.6)\n* Drug or alcohol abuse during treatment\n* Previous enrolment in the current study\n* Enrolment of the investigator, his/her family members, employees and other dependent persons\n* During study: Complete stop of taking antipsychotic medications","locations":[{"facility":"Psychiatric University Hospital Zurich","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rahel Horisberger, Dr.phil.","phone":"+41 58 384 26 52","email":"rahel.horisberger@pukzh.ch"},{"name":"Janani Panchalingam, M.Sc.","phone":"+41 58 384 24 23","email":"janani.panchalingam@pukzh.ch"}],"primaryOutcomes":["Change from first session in Therapeutic Alliance on the Scale to Assess Therapeutic Relationship","Change from Baseline in Treatment Adherence on the electronic patient records"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["zurich-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: Motivational Interviewing for Psychosis","inPlainEnglish":"Psychotic disorders are associated with high levels of distress, limitations in quality of life, and a high risk of chronification for those affected. The treatment guidelines recommend combining the pharmacological treatment with psychotherapeutic methods, starting already in the acute phase.","whoItsFor":["Ages 18 Years to 65 Years","Male and female patients from inpatient units of the Psychiatric University Hospital of Zurich","ICD-10 diagnosis of a mental disorder with psychotic symptoms, including schizophrenia, schizotypal and delusional disorders (F20-F29), affective disorders with psychotic features (F30.2, F31.2, F31.5, F32.3, F33.3) and substance-induced psychotic disorders (F1x.5)"],"whoShouldSkip":["Organic schizophrenia-like disorder (ICD: F0.6)","Drug or alcohol abuse during treatment","Previous enrolment in the current study","Enrolment of the investigator, his/her family members, employees and other dependent persons","During study: Complete stop of taking antipsychotic medications"],"whatHappens":"If you join, the listed intervention(s) are Motivational Interviewing, or Psychoeducation. The registry lists allocation as randomized. Psychotic disorders are associated with high levels of distress, limitations in quality of life, and a high risk of chronification for those affected.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 128 people at Zurich. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.035Z"},{"nctId":"NCT05913947","title":"Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression (DUAG9)","officialTitle":"Lithium Versus Cariprazine in the Acute Phase Treatment of Bipolar Depression: a Pragmatic Head-to-head Open, Randomized Multicenter Study: The 9th Study of the Danish University Antidepressant Group (DUAG 9)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Aalborg University Hospital","sponsorClass":"OTHER","summary":"The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.\n\nThe main question it aims to answer is:\n\nDifference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6)\n\nParticipants will be randomized to treatment with either lithium or cariprazin.\n\n* Will meet for interview and ratings 4 times during study period.\n* In two meetings, there will be made blood samples and ECG. At one meeting also a Urine sample.\n* Will be contacted for telephone interviews at 6 occasions.","conditions":["Depression, Bipolar"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lithium"},{"type":"DRUG","name":"Cariprazine"}],"enrollment":122,"startDate":"2022-12-13","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5\n* Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI).\n* No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion.\n* No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion.\n* Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization.\n* The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization.\n* Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case.\n* Female participants should be sterile or non-fertile or, in case of being fertile, they must have a negative pregnancy test AND use safe anticonception.\n* Signed document of informed consent.\n\nExclusion Criteria:\n\n* Prior or ongoing acute treatment of a depressive episode lasting \\> 14 days with either lithium or cariprazine as judged by the investigator.\n* ECT within the current depressive episode.\n* A score of MAS \\> 6.\n* A diagnosis of dementia.\n* High risk of non-adherence at the investigator's discretion.\n* Not understanding the Danish language as judged by the investigator\n* Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care.\n* Presence of clinically relevant delusions, hallucinations or other psychotic symptoms as judged by the investigator.\n* Suicidality according to C-SSRS with a positive response to question 4 or 5 or upon investigator's discretion.\n* Medical conditions like cancer, kidney failure, epilepsy, deep brain stimulation device, or other medical conditions interfering with study the outcome and safety as judged by investigator's discretion.\n* Current harmful use or dependency of alcohol or drugs according to DSM-5.\n* Known allergy to any of the substances in the study medication.","locations":[{"facility":"Aalborg University Hospital","city":"Aalborg","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sanne V. Hovgesen, MD","phone":"+45 25487706","email":"sanne.hovgesen@rn.dk"},{"name":"Simon Johnsen, MsN","phone":"+45 50589034","email":"simonjohnsen@rn.dk"}],"primaryOutcomes":["Change in Hamilton Depressions scale, version 6 (HDS-6)"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["aalborg-denmark"],"enrichment":{"headline":"Phase 4: testing Lithium for Depression, Bipolar","inPlainEnglish":"The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease. The main question it aims to answer is: Difference in change between the two groups from baseline to after 8 weeks treatment on Hamilton Ratings Scale for Depression, 6-item version (HDS-6) you would be randomly assigned to treatment with either lithium or cariprazin.","whoItsFor":["Ages 18 Years to 65 Years","A diagnosis of bipolar disorder, type 1 or type 2, and a current episode of depression according to DSM-5","Severity of depression: A score of at least 21 on the self-reported Major Depression Inventory (MDI)","No start or dose increase of psychotropic medication (except for benzodiazepines and benzodiazepine-like drugs (zopiclone, zolpidem, and melatonin)) in the two weeks prior to inclusion","No new start of formalized psychotherapy sessions, excluding psychoeducation, during the 4 weeks prior to inclusion","Age criteria: Subjects must be at least 18 years old and below 65 at the time of randomization","The duration of the current depressive episode must be between 4 and 52 weeks as judged by the investigator at the time of randomization","Clinical uncertainty regarding which of the alternatives, cariprazine and lithium, would be the better choice in the specific case"],"whoShouldSkip":["Prior or ongoing acute treatment of a depressive episode lasting \\> 14 days with either lithium or cariprazine as judged by the investigator","ECT within the current depressive episode","A score of MAS \\> 6","A diagnosis of dementia","High risk of non-adherence at the investigator's discretion","Not understanding the Danish language as judged by the investigator","Psychiatric coercion in the form of forced admission or detainment OR sentence to forensic psychiatric care"],"whatHappens":"If you join, the listed intervention(s) are Lithium, or Cariprazine. The registry lists allocation as randomized. The goal is to study the effect of lithium compared to cariprazine in patients with depression in a bipolar disease.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 122 people at Aalborg. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.733Z"},{"nctId":"NCT05915013","title":"Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response","officialTitle":"Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. The purpose of this study is to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.","conditions":["Depressive Disorder, Major","Post Traumatic Stress Disorder"],"keywords":["Ketamine","Major Depression","Post Traumatic Stress Disorder","AMPA Receptor","Magnetic Resonance Imaging"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"DRUG","name":"Perampanel"},{"type":"DRUG","name":"Placebo"}],"enrollment":50,"startDate":"2023-09-07","completionDate":"2032-12","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria Substudy #2:\n\n* Right-handed as determined by the Edinburgh Handedness Inventory\n* Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale\n* Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials\n* Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label trial.\n* Participants will meet DSM-5 Criteria for MDD as determined by the SCID-5\n* All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment.\n* Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime of pharmacotherapy for the duration of the trial.\n* Individuals who are receiving psychotherapy must have been in treatment for four weeks and should have a plan to continue the current regime of psychotherapy for the duration of the trial.\n* Willing to refrain from caffeine, drug and alcohol use for one week prior to each MRI session\n* Females will be included if they are not pregnant or breastfeeding and agree to utilize a medically accepted birth control method (to include oral, injectable, or implant birth control, condom, diaphragm with spermicide, intrauterine device, tubal ligation, abstinence, or partner with vasectomy). Women who are surgically sterile or post-menopausal with cessation of menses for at least one year are not required to use birth control. If a woman should become pregnant during the study, she will be excluded from the trial.\n* Females will receive ketamine during the follicular phase, i.e., in the first week after the start of the menstrual period, if at all possible. If a prospective participant typically has significant menstrual cramps during this entire follicular phase, she will be studied during another part of her cycle. She will be studied during the same part of her cycle for each scan, if possible.\n* Able to read and write English\n* Have at least a 12th grade education level or equivalent\n\nExclusion Criteria Substudy #2:\n\n* A score on the Columbia Suicide Severity Rating Scale in the \"intent\" or \"intent with plan\" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide.\n* Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is indicated by the presence of any of the following:\n\n  * More than half hour unconsciousness after trauma\n  * More than one hour post-traumatic amnesia\n  * Concussive symptoms such as headache, memory problems, nausea/vomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury.\n  * Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties.\n  * Four or more concussive events of less severity than the above will also be grounds for exclusion. These events would include post-trauma symptoms such as the individual being dazed, seeing stars, unconscious for less than one half hour, or post-traumatic amnesia of less than an hour.\n* Current therapeutic treatment with ketamine\n* Current treatment with topiramate, memantine, or barbiturates within two weeks of randomization\n* Daytime use of benzodiazepines\n* Current treatment with monoamine oxidase inhibitors within 4 weeks of randomization\n* Treatment with a vagal nerve stimulator, ECT or deep brain stimulation within two weeks of randomization\n* Psychosis other than psychotic experiences congruent with depressed mood during a period of depression\n* Insulin-dependent diabetes or non-insulin dependent diabetes that is poorly controlled\n* Other major medical disorder unless cleared by a study physician\n* History of violence unless cleared by Dr. Driesen or Dr. Krystal because of extenuating circumstances. For example, an individual whose violent behavior was always coupled with substance abuse and had obtained stable sobriety with no violent incidents or an individual who had received successful pharmacotherapy for impulse control difficulties may be included.\n* Individual meets criteria for a diagnosis of substance or alcohol use disorder within the three months prior to screening date. Individuals who meet criteria for mild alcohol use disorder within three months prior to screening date may be included in the study at investigator discretion. The diagnosis of mild alcohol use disorder shall be per DSM-5 and involve 2-3 symptoms. The PI's discretion will be based on the symptoms that are reported. The purpose of including individuals with mild alcohol use disorder is to extend recruitment to more individuals who can participate safely in the trial.\n* A positive on screening urine drug test or, at the study physicians' discretion, on any drug screens given before the scans.\n* A positive screening breathalyzer test or, at the study physicians' discretion, on any breathalyzer test given before the scans. This applies to all subjects, including those who make criteria for current mild alcohol use disorder.\n* A 12-lead ECG at screening has clinically significant abnormalities as determined by the physician reading the ECG.\n* Abnormality on clinical chemistry or hematology examination at the pre-study medical screening. Subjects with laboratory parameters outside the reference range for this age group will only be included if the study physician considers that such findings will not introduce additional risk factors.\n* History of positive HIV or Hepatitis B\n* Has received either prescribed or over-the-counter (OTC) centrally active medicine or herbal supplements within the week prior to the MRI scan. Subjects who have taken OTC medication or herbal supplements may still be entered into the study, if, in the opinions of the Principal/Co-Investigator, the medication received will not interfere with the study procedures or compromise safety.\n* Known sensitivity to ketamine or heparin\n* Resting blood pressure lower than 85/55 or higher than 140/90, or resting heart rate lower than 45/min or higher than 100/min, unless cleared by study physician. If a subject meets these blood pressure entrance criteria, but is being treated for high blood pressure, the study team will check with the subject's primary care physician or treatment provider to confirm that the subject is stable and normotensive on their current treatment plan.\n* History of general intellectual disability\n* History of claustrophobia\n* Any clinically significant impairment of color vision or visual acuity after correction available in the scanner\n* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a Yale Magnetic Resonance Research Center standard pre-MRI screening questionnaire\n* Subjects will be advised not to drive or operate heavy machinery for at least 24 hours after completing the infusion.\n* Donation of blood in excess of 500 mL within 56 days prior to dosing or similar loss of blood due to other causes.\n* Potential participants may be eliminated at the discretion of Dr. Krystal, Dr. Driesen, or the study physician.","locations":[{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naomi Driesen, Ph.D.","phone":"203-508-7765","email":"naomi.driesen@yale.edu"},{"name":"Elizabeth Traester, B.A.","phone":"","email":"elizabeth.traester@yale.edu"}],"primaryOutcomes":["Prefrontal functional connectivity","Cerebral metabolic rate of oxygen (CMRO2)"],"hasResults":false,"conditionSlugs":["als","depression","ptsd"],"drugSlugs":["ketamine"],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Phase 1: testing Ketamine for Depressive Disorder, Major","inPlainEnglish":"The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression. this study wants to test the hypothesis that stimulation of Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid receptors (AMPAR) is critical to the anti-depressant response of ketamine.","whoItsFor":["Ages 18 Years to 60 Years","Right-handed as determined by the Edinburgh Handedness Inventory","Current depression as indicated by a score greater than 17 on the full Hamilton Depression Rating Scale","Anti-depressant resistant depressive symptoms, defined by a history of failure of one or more adequate anti-depressant trials","Individuals who have previously received ketamine must have had a positive response. Individuals who report reduced depressive symptoms will be treated as ketamine responders and entered directly into the closed label trial","Participants will meet DSM-5 Criteria for major depression as determined by the SCID-5","All participants given ketamine must be engaged in treatment outside of the research protocol. Those who are not currently in treatment may be referred for treatment","Individuals who are receiving pharmacotherapy for depression must have been receiving the current medication and dose for 4 weeks before randomization. In addition, they should have a plan to continue the current regime of pharmacotherapy for the duration of the trial"],"whoShouldSkip":["A score on the Columbia Suicide Severity Rating Scale in the \"intent\" or \"intent with plan\" categories or judged by Dr. Krystal or Dr. Driesen to be at serious risk for suicide","Neurological disorder excluding migraine headaches or more than mild head injury. Individuals with migraines will not complete any ketamine infusion visits within 24 hours of a migraine. More than mild head injury is indicated by the presence of any of the following:","More than half hour unconsciousness after trauma","More than one hour post-traumatic amnesia","Concussive symptoms such as headache, memory problems, nausea/vomiting, irritability, ringing in the ears, dizziness, balance problems, difficulty concentrating or visual disturbances lasting more than one week after injury","Concussive symptoms as defined above in the first week after injury causing more than one day impairment in typical duties","Current therapeutic treatment with ketamine"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, Perampanel, or Placebo. The registry lists allocation as randomized. The proposed study will assess the combined effect of perampanel and ketamine on the anti-depressant response in individuals with treatment resistant depression.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.794Z"},{"nctId":"NCT05916339","title":"AWARE: Management of ADHD in Autism Spectrum Disorder","officialTitle":"Comparative Effectiveness of Pharmacologic Management of ADHD in Children and Youth With Autism Spectrum Disorder","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daniel Coury","sponsorClass":"OTHER","summary":"This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.","conditions":["ADHD","Autism Spectrum Disorder"],"keywords":["ADHD","Autism","ASD"],"interventions":[{"type":"DRUG","name":"Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication"},{"type":"DRUG","name":"Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant."}],"enrollment":500,"startDate":"2023-10-01","completionDate":"2027-01-01","sex":"ALL","minAge":"4 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant and/or legal caregiver must be willing and able to give informed consent/assent for participation in this study.\n2. Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements.\n3. Participant must be between 4 and 17 years of age (inclusive) at time of enrollment.\n4. Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.).\n5. Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid).\n6. Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence).\n7. Participant must have a consistent reporter (e.g., parent) who spends regular time with the child.\n8. Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \\> 4 weeks prior to consent with no plans for a dose change during the study.\n9. It has been at least 7 days since the participant last took an ADHD medication and the presiding clinician believes this to be a sufficient amount of time.\n10. Caregiver must be sufficiently fluent in English or Spanish to be able to complete questionnaires relevant to this study.\n\nExclusion Criteria:\n\n1. Participant has taken ADHD medication within the past 7 days.\n2. Participant is not stable on other medications (\\< 4 weeks).\n3. Any other risk factor that might prevent patient from safely taking the study medications.\n\n   * There are no inclusion/exclusion criteria based upon participant IQ. We will include individuals across the entire range of cognition, just as practitioners are asked to treat ADHD in children with ASD across the entire IQ range.","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maine Medical Center","city":"Portland","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital Lurie Center for Autism","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health Upstate","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta, Glenrose Rehabilitation Hospital","city":"Edmonton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holland Bloorview Kids Rehabilitation Hospital","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amanda James, BS","phone":"(614) 722-4006","email":"Amanda.James@nationwidechildrens.org"},{"name":"Samantha Sharpe","phone":"(614) 722-8509","email":"Samantha.Sharpe@nationwidechildrens.org"}],"primaryOutcomes":["The Vanderbilt Parent Rating Scale"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["irvine-california","los-angeles-california","portland-maine","boston-massachusetts","rochester-new-york","cincinnati-ohio","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","greenville-south-carolina","charlottesville-virginia","edmonton-canada","toronto-canada"],"enrichment":{"headline":"Phase 4: testing Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication for ADHD","inPlainEnglish":"This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists.","whoItsFor":["Ages 4 Years to 17 Years","Participant and/or legal caregiver must be willing and able (in the Investigator's opinion) to comply with all study requirements","Participant must be between 4 and 17 years of age (inclusive) at time of enrollment","Participant must have a confirmed diagnosis of ASD based on supportive evidence (e.g. referring physician's report, medical records, such as ADOS or CARS, etc.)","Participant must have the ability to consistently take medication (via pill, liquid or mixed with food/liquid)","Participant must have a confirmed diagnosis of ADHD (based upon DSM-5 criteria and supportive evidence)","Participant must have a consistent reporter (e.g., parent) who spends regular time with the child","Participant can be on other psychotropic medications (selective serotonin reuptake inhibitor (SSRI), atypical antipsychotic, anticonvulsant) if dose has been stable for \\> 4 weeks prior to consent with no plans for a dose change during the study"],"whoShouldSkip":["Participant has taken ADHD medication within the past 7 days","Participant is not stable on other medications (\\< 4 weeks)","Any other risk factor that might prevent patient from safely taking the study medications","There are no inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Randomization to either Amphetamine (AMP) class of stimulant medication or Methylphenidate (MPH) class of stimulant medication, or Randomization to either Alpha 2 agonist class of medication or alternate class of stimulant.. The registry lists allocation as randomized. This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 500 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.651Z"},{"nctId":"NCT05920356","title":"A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)","officialTitle":"A Phase 3, Multicenter, Randomized, Open-label Study Evaluating Efficacy of Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Subjects With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers, Negative for PD-L1, and Positive for KRAS p.G12C (CodeBreaK 202)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Amgen","sponsorClass":"INDUSTRY","summary":"The primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.","conditions":["Non-Small Cell Lung Cancer (NSCLC)"],"keywords":["Oncology","Lung Cancer","PD-L1","KRAS p.G12C","Sotorasib","Pembrolizumab","Carboplatin","Pemetrexed","CodeBreaK 202","NSCLC","PD-L1 Negative","AMG 510","LUMAKRAS ®","LUMYKRAS ®"],"interventions":[{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":750,"startDate":"2023-11-16","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of nonsquamous stage IV or advanced Stage IIIB or IIIC NSCLC with KRAS p. G12C mutation and negative for PD-L1 expression by central testing or local laboratory testing confirmed through central testing\n* No history of systemic anticancer therapy in metastatic/non-curable settings\n* Eastern Cooperative Oncology Group (ECOG) ≤ 1\n\nExclusion Criteria:\n\n* Mixed histology NSCLC with either small-cell or large-cell neuroendocrine cell component or predominant squamous cell histology\n* Participants with tumors known to harbor molecular alterations for which targeted therapy is locally approved as a front-line therapy\n* Symptomatic (treated or untreated) brain metastases\n* Gastrointestinal (GI) tract disease causing the inability to take oral medication\n* Myocardial infarction within 6 months of randomization, unstable arrhythmias, or unstable angina\n* Prior therapy with a KRAS G12C inhibitor","locations":[{"facility":"Sansum Clinic","city":"Santa Barbara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Hematology Consultants Helen F Graham Cancer Center","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boca Raton Clinical Research Coral Springs","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regis Clinical Research LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Clinical Trials Group Tamarac","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Cancer Specialists","city":"Niles","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Waterloo","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute - Brownsboro","city":"Louisville","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Reliant Medical Group Inc","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico Cancer Center","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Messino Cancer Centers Asheville","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center Duke Cancer Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FirstHealth Cancer Center","city":"Pinehurst","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dayton Physician's Network","city":"Dayton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Cancer Specialists - Media","city":"Media","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Guthrie Medical Group","city":"Sayre","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina Health Lancaster Medical Center","city":"Lancaster","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Medical Center Knoxville","city":"Knoxville","state":"Tennessee","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Regional One Health","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants PA","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vista Oncology Inc PS","city":"Olympia","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercyhealth","city":"Janesville","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Argentino de Diagnostico y Tratamiento IADT","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"TERMINATED","lat":null,"lon":null},{"facility":"Hospital Britanico de Buenos Aires","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"TERMINATED","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming","city":"Capital Federal","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de La Plata","city":"La Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Ars 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I Politecni La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Hospital for Sick Children","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nowgen Centre, Research and Innovation","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Manchester Children's Hospital","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Radcliffe Hospital","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants with Clinical Remission at Week 52","Percentage of Participants Who Achieve Endoscopic Response at Week 52"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["los-angeles-california","hartford-connecticut","atlanta-georgia","indianapolis-indiana","boston-massachusetts","morristown-new-jersey","new-york-new-york","dayton-ohio","philadelphia-pennsylvania","fort-worth-texas","colchester-vermont","nedlands-australia","south-brisbane-australia","westmead-australia","vienna-austria","brussels-belgium","ghent-belgium","leuven-belgium","campinas-brazil","curitiba-brazil","goi-nia-brazil","porto-alegre-brazil","vit-ria-brazil","votuporanga-brazil","halifax-canada","london-canada","toronto-canada","amiens-france","lille-france","paris-france","beersheba-israel","beer-ya-aqov-israel","jerusalem-israel","petah-tikva-israel","rehovot-israel","alessandria-italy","bergamo-italy","bologna-italy","florence-italy","milan-italy","roma-italy","hirosaki-japan","kagoshima-japan","kashiwa-shi-japan","kobe-japan","saga-japan","sendai-japan","setagaya-ku-japan","tokyo-japan","tsu-japan","ube-japan","yokohama-japan","rotterdam-netherlands","nordbyhagen-norway","oslo-norway","troms-norway","trondheim-norway","rzesz-w-poland","warsaw-poland","braga-portugal","lisbon-portugal","porto-portugal","busan-south-korea","daegu-south-korea","seoul-south-korea","c-rdoba-spain","sabadell-spain","valencia-spain","glasgow-united-kingdom","london-united-kingdom","manchester-united-kingdom","oxford-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Guselkumab for Crohn's Disease","inPlainEnglish":"This study wants to measure the clinical and endoscopic how well it works of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.","whoItsFor":["Ages 2 Years to 17 Years","Participants must have a diagnosis of Crohn's Disease (CD) or fistulizing CD, with active colitis, ileitis, or ileocolitis, confirmed at any time in the past by clinical, endoscopic, and histologic criteria","Participants must have moderately to severely active CD (as defined by a baseline Pediatric Crohn's Disease Activity Index \\[PCDAI\\] score greater than or equal to \\[\\>=\\] 30)","Participants must have endoscopy with evidence of active CD defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score greater than or equal to (\\>=) 6 (or \\>=4 for participants with isolated ileal disease) within 1 month of receiving study intervention at Week 0"],"whoShouldSkip":["Participants has complications of CD such as symptomatic strictures or stenosis, short gut syndrome, or any other manifestation that might be anticipated to require surgery","Participants must not have an abscess","Participants must not have any kind of bowel resection within 26 weeks or any other intra-abdominal surgery within 12 weeks of baseline"],"whatHappens":"If you join, the listed intervention(s) are Guselkumab, or Guselkumab. The registry lists allocation as randomized. This study wants to measure the clinical and endoscopic how well it works of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 120 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.895Z"},{"nctId":"NCT05925621","title":"Cognitive Neurology Unit Clinical Registry","officialTitle":"Cognitive Neurology Unit's Anti-amyloid Monoclonal Antibodies for the Treatment of Alzheimer's Disease Clinical Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Beth Israel Deaconess Medical Center","sponsorClass":"OTHER","summary":"A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lecanemab"}],"enrollment":500,"startDate":"2023-07-16","completionDate":"2028-06","sex":"ALL","minAge":"50 Years","maxAge":"95 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease\n\n  * Patient has evidence of cognitive impairment on neuropsychological testing\n  * Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement\n  * Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease\n  * Amyloid PET imaging positive\n  * CSF p-Tau/Abeta42 ration \\>0.023 and ABeta42 \\< 1027\\*\\*\n  * 3T MRI in past 6 months\n  * Patient has a care partner\n  * Patient under the care of an appropriate BI-Lahey amyloid clinic\n  * Patient is on a stable medication regimen\n\nExclusion Criteria:\n\n* o Recent stroke or suspected TIA in the past year\n\n  * Pregnancy\n  * Active autoimmune or immunological disease\n  * Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives\n  * Bleeding disorder with Plts \\< 50,000 or INR \\> 1.5\n  * On warfarin, heparin, or DOAC\n  * On dual antiplatelet therapy\n  * Non Alzheimer disease cause of dementia/MCI\n  * ApoE e4 homozygote","locations":[{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dan Z Press, MD","phone":"(617) 667-4074","email":"dpress@bidmc.harvard.edu"},{"name":"Chun Lim, MD","phone":"(617) 667-4074","email":"clim@bidmc.harvard.edu"}],"primaryOutcomes":["To Determine Whether Anti-Amyloid Mabs Slow Cognitive And Functional Decline","To Identify Any Associations Between Side Effects And Patient Characteristics","To Establish The Time Course Of Clinical Benefits"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: testing Lecanemab for Alzheimer Disease","inPlainEnglish":"A Prospective Comparative Study Of Monoclonal Antibodies For The Treatment Of Alzheimer's Disease","whoItsFor":["Ages 50 Years to 95 Years","o Patient meets clinical criteria for mild cognitive impairment or early dementia from Alzheimer's disease","Patient has evidence of cognitive impairment on neuropsychological testing","Patient has not progressed to the moderate stage of dementia based on neuropsychological testing or clinical judgement","Amyloid PET imaging and/or CSF analysis consistent with Alzheimer's disease","Amyloid PET imaging positive","CSF p-Tau/Abeta42 ration \\>0.023 and ABeta42 \\< 1027\\*\\*","3T MRI in past 6 months"],"whoShouldSkip":["o Recent stroke or suspected TIA in the past year","Active autoimmune or immunological disease","Systemic treatment with immunosuppressants, immunoglobulins, or monoclonal antibodies or their derivatives","Bleeding disorder with Plts \\< 50,000 or INR \\> 1.5","On warfarin, heparin, or DOAC","On dual antiplatelet therapy","Non Alzheimer disease cause of dementia/MCI"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.232Z"},{"nctId":"NCT05925959","title":"Preoperative Weight Loss for Open Abdominal Wall Reconstruction","officialTitle":"Preoperative Weight Loss for Open Abdominal Wall Reconstruction","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Benjamin T. Miller","sponsorClass":"OTHER","summary":"The goal of this randomized controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.","conditions":["Abdominal Wall Hernia"],"keywords":[],"interventions":[{"type":"OTHER","name":"Preoperative Weight Management Program"}],"enrollment":258,"startDate":"2023-06-19","completionDate":"2028-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria\n\n* Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh\n* BMI 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery.\n\nExclusion criteria\n\n* Lack of English language fluency\n* Urgent need for repair as determined by surgeon judgement\n* Pregnant patients\n* Permanent stoma in place\n* Isolated flank hernia\n* Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction.\n* BMI \\<40 or \\>55 kg/m2\n* Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.).\n* Obstructive symptoms","locations":[{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Main Campus","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Benjamin T Miller, MD","phone":"216 406-8573","email":"millerb35@ccf.org"},{"name":"Erika Schmidt, MD","phone":"2163723107","email":"schmide7@ccf.org"}],"primaryOutcomes":["Abdominal core health-specific quality of life at 1 year"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["chicago-illinois","cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Preoperative Weight Management Program for Abdominal Wall Hernia","inPlainEnglish":"The goal of this randomly assigned controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction. The main question is will abdominal wall specific quality of life (using the HerQLes survey) for the group undergoing upfront surgery be non-inferior compared to the group in the weight management program.","whoItsFor":["Ages 18 Years to any","Adults having open retromuscular ventral hernia repair with an anticipated posterior component separation with transversus abdominis release and synthetic mesh","body-mass index (BMI) 40-55 kg/m2 and who are not planning to pursue weight loss surgery for any of the following reasons: they are not a candidate for weight loss surgery, cannot pursue weight loss surgery for insurance reasons, or are not interested in pursuing weight loss surgery"],"whoShouldSkip":["Lack of English language fluency","Urgent need for repair as determined by surgeon judgement","Permanent stoma in place","Isolated flank hernia","Anticipated need for staged operation; for example, patients who will undergo a mesh excision separate from definitive reconstruction","body-mass index (BMI) \\<40 or \\>55 kg/m2","Inability to participate in the Obesity Management Program due to lack of insurance coverage or history of mental illness (including eating disorders, schizophrenia, etc.)"],"whatHappens":"If you join, the listed intervention(s) are Preoperative Weight Management Program. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to compare preoperative intensive weight management to upfront surgery in obese patients undergoing complex abdominal wall reconstruction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 258 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.719Z"},{"nctId":"NCT05927571","title":"A Study Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)","officialTitle":"An Open-Label, Multicenter, Phase Ib Trial Evaluating the Safety, Pharmacokinetics, and Activity of the Combination of Cevostamab and Elranatamab in Patients With Relapsed or Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to evaluate safety and tolerability of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.","conditions":["Relapsed or Refractory Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cevostamab"},{"type":"DRUG","name":"Elranatamab"},{"type":"DRUG","name":"Tocilizumab"}],"enrollment":120,"startDate":"2023-08-10","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Diagnosis of R/R MM per IMWG criteria\n* For female participants of childbearing potential: agreement to remain abstinent or use contraception\n* For male participants: agreement to remain abstinent or use a condom\n\nExclusion Criteria:\n\n* Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)\n* Prior treatment with elranatamab\n* Prior allogeneic stem cell transplantation (SCT)\n* Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells\n* Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome\n* Participants with known history of amyloidosis\n* History of autoimmune disease\n* History of confirmed progressive multifocal leukoencephalopathy\n* Peripheral motor polyneuropathy of prespecified grade\n* Known or suspected chronic cytomegalovirus (CMV) and/or Epstein-Barr virus (EBV) infection\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* Acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection\n* Human immunodeficiency virus (HIV) seropositivity\n* History of central nervous system (CNS) myeloma disease\n* Significant cardiovascular disease","locations":[{"facility":"Royal Prince Alfred Hospital","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Calvary Mater Newcastle","city":"Waratah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital;Haematology Clinical Trials Unit","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Vincent's Hospital Melbourne","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred Hospital","city":"Prahan","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center - PPDS","city":"Ramat Gan","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah University Hospital - Ein Kerem","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center PPDS","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital)","city":"Seocho","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center.","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center - PPDS","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"GO43979 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Number of Participants With Adverse Events (AEs)","Recommended Phase II Regimen (RP2R)"],"hasResults":false,"conditionSlugs":["multiple-myeloma","als"],"drugSlugs":[],"locationSlugs":["camperdown-australia","waratah-australia","adelaide-australia","melbourne-australia","prahan-australia","ramat-gan-israel","haifa-israel","jerusalem-israel","tel-aviv-israel","seocho-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing Cevostamab for Relapsed or Refractory Multiple Myeloma","inPlainEnglish":"The purpose of the study is to evaluate whether it is safe and how hard side effects are to live with of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment. The study consists of a safety lead-in stage, and an expansion stage.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1","Diagnosis of R/R MM per IMWG criteria","For female participants of childbearing potential: agreement to remain abstinent or use contraception","For male participants: agreement to remain abstinent or use a condom"],"whoShouldSkip":["Prior treatment with cevostamab or another agent targeting fragment crystallizable receptor-like 5 (FcRH5)","Prior treatment with elranatamab","Prior allogeneic stem cell transplantation (SCT)","Absolute plasma cell count exceeding 500 per milliliter (mL) or 5% of the peripheral blood white cells","Diagnosis of Waldenström macroglobulinemia or polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, skin changes (POEMS) syndrome","Participants with known history of amyloidosis","History of autoimmune disease"],"whatHappens":"If you join, the listed intervention(s) are Cevostamab, Elranatamab, or Tocilizumab. The registry lists allocation as randomized. The purpose of the study is to evaluate whether it is safe and how hard side effects are to live with of the combination of cevostamab plus elranatamab and also determine the recommended Phase II regimen (RP2R) for the study treatment.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 120 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.495Z"},{"nctId":"NCT05928039","title":"PATHFINDER: Evaluating the Optimal First-Line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease","officialTitle":"PATHFINDER: A Pragmatic, Active-comparator, Parallel-group, Randomized Trial to Evaluate the Optimal First-line Treatment Strategy for Moderate-to-Severely Active Ileal-dominant Crohn's Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Calgary","sponsorClass":"OTHER","summary":"There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \\[TNF\\] alpha, anti-integrin, and anti-interleukin \\[IL\\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year. Endoscopic remission means that the ulcers in the small bowel from Crohn's disease have healed. All treatments in this trial are approved by Health Canada. No experimental drugs will be included.","conditions":["Crohn Disease"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"TNFa Antagonist - Infliximab"},{"type":"BIOLOGICAL","name":"TNFa Antagonist - Adalimumab"},{"type":"BIOLOGICAL","name":"Anti-IL12/23 or anti-IL23 - Ustekinumab"},{"type":"BIOLOGICAL","name":"Anti-IL12/23 or anti-IL23 - Risankizumab"},{"type":"BIOLOGICAL","name":"Anti-integrin - Vedolizumab IV"},{"type":"BIOLOGICAL","name":"Anti-integrin - Vedolizumab IV and SC"}],"enrollment":210,"startDate":"2023-10-25","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or nonpregnant, nonlactating females, 18 years of age or older. Females of childbearing potential must have a negative serum or urine pregnancy test prior to randomization\n2. Established CD diagnosis by conventional criteria\n3. Baseline colonoscopy within 3 months of the first day of the screening period, with photo or video documentation of at least one large ileal ulcer \\>5 mm and ileal segment SES-CD ≥4 (eligibility will be determined by local endoscopist, with subsequent confirmation by a CR at a later time, post enrolment)\n4. Biologic-treatment naïve for CD-related therapies\n5. Would otherwise have been eligible to start a biologic for moderate-to-severely active CD as part of their routine clinical care and for whom there is equipoise around which biologic class to start\n6. Willing and able to participate fully in all aspects of this clinical trial, including adherence to study protocol and treatment algorithm\n\n8\\. Written informed consent must be obtained and documented\n\nExclusion Criteria:\n\n1. Condition(s) for which the biologics included in this study is contraindicated\n2. CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)\n3. Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis\n4. Recent bowel resection \\<3 months before screening\n5. Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections\n6. Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection\n7. Active COVID-19 infection during the screening period\n8. Tested positive as part of SOC for tuberculosis (TB) at screening by QuantiFERON® TB Gold Test, tuberculin skin test, or history of untreated latent or active TB\n9. History of malignancy within 5 years of screening, except fully treated carcinoma in-situ of the cervix, fully treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin\n10. Active chronic or acute infections requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics, or antiprotozoals during the screening period\n11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study\n12. Pregnancy or breastfeeding\n13. Not willing to withhold protocol-prohibited medications during the trial, or planned or anticipated use of any prohibited medications during screening\n14. Received previously or currently receiving a TNF antagonist, anti-integrin, monoclonal antibody targeting IL-12/23 or IL-23, Janus kinase (JAK) inhibitors, or sphingosine 1 phosphate (S1P) receptor modulators (irrespective of indication)\n15. History of alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta IBD Clinic","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Research Institute (G.I.R.I)","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Coast Gastroenterology","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nova Scotia Health Victoria","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GNRR Digestive Clinics and Research Center Inc.","city":"Brampton","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"GNRR Digestive Clinics and Research Center Inc","city":"Brampton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rajbir Rai Medical Corporation","city":"Brantford","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McMaster University","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Digestive Disease Institute","city":"London","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"West GTA Research Inc.","city":"Mississauga","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"West GTA Research Inc","city":"Mississauga","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"ABP Research Services Corp.","city":"Oakville","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taunton Surgical Center","city":"Oshawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital Research Institute","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thunder Bay Regional Health Research Institute","city":"Thunder Bay","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sinai Health System","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"TIDHI Clinic","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital du Sacré-Cœur-de-Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute of the McGill University Health Centre (MUHC)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Université de Sherbrooke","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Harsha Ashton","phone":"226-919-6959","email":"harsha.ashton@alimentiv.com"},{"name":"Christopher Ma, MD MPH","phone":"4035925013","email":"christopher.ma@ucalgary.ca"}],"primaryOutcomes":["Corticosteroid-free endoscopic remission"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab","risankizumab"],"locationSlugs":["calgary-canada","edmonton-canada","vancouver-canada","halifax-canada","brampton-canada","brantford-canada","hamilton-canada","london-canada","mississauga-canada","oakville-canada","oshawa-canada","ottawa-canada","thunder-bay-canada","toronto-canada","montreal-canada","sherbrooke-canada"],"enrichment":{"headline":"Phase 4: testing TNFa Antagonist - Infliximab for Crohn Disease","inPlainEnglish":"There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \\[TNF\\] alpha, anti-integrin, and anti-interleukin \\[IL\\]-23 targeted agents. The purpose of this trial is to determine which of these three classes of biologics results in the highest percentage of patients with small bowel (ileal) Crohn's disease entering into endoscopic remission without needing corticosteroids at 1 year.","whoItsFor":["Ages 18 Years to any","Male or nonpregnant, nonlactating females, 18 years of age or older. Females of childbearing potential must have a negative serum or urine pregnancy test prior to randomization","Established CD diagnosis by conventional criteria","Biologic-treatment naïve for CD-related therapies","Would otherwise have been eligible to start a biologic for moderate-to-severely active CD as part of their routine clinical care and for whom there is equipoise around which biologic class to start","Willing and able to participate fully in all aspects of this clinical trial, including adherence to study protocol and treatment algorithm"],"whoShouldSkip":["Condition(s) for which the biologics included in this study is contraindicated","CD-related complications such as symptomatic, endoscopically impassable strictures or abscesses that require imminent surgery (at investigator's discretion)","Participants with current or history of colonic dysplasia or neoplasia, toxic megacolon, or fulminant colitis","Recent bowel resection \\<3 months before screening","Active enteric infection (positive stool culture), including but not limited to bacterial (including C. difficile), viral, or parasitic enteric infections","Known active hepatitis B, hepatitis C, or human immunodeficiency virus infection","Active COVID-19 infection during the screening period"],"whatHappens":"If you join, the listed intervention(s) are TNFa Antagonist - Infliximab, TNFa Antagonist - Adalimumab, or Anti-IL12/23 or anti-IL23 - Ustekinumab. The registry lists allocation as randomized. There are currently three classes of biologic treatments approved in Canada for the management of moderate-to-severe Crohn's disease: anti-tumor necrosis factor \\[TNF\\] alpha, anti-integrin, and anti-interleukin \\[IL\\]-23 targeted agents.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 210 people at 23 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.264Z"},{"nctId":"NCT05936619","title":"MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System","officialTitle":"MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Nader Pouratian","sponsorClass":"OTHER","summary":"This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender). It utilizes four implanted \"chips\" in the human brain from which investigators can record brain activity during subjects' thoughts and decode meaningful information from this activity to be used as control signals for a computer, a laptop, or a tablet. The use of four brain regions is a significant differentiating feature and scientific innovation of this study over much prior work in this space, that typically derived control signals from one, or sometimes two brain regions. The brain regions to be used here can allow the decode of multiple variables simultaneously, including not just moment-to-moment position, but also high-level goals, intentions, decisions, scene comprehension, and error-related signals involved in natural human behavior. The research is being done through a prospective, longitudinal, single-arm early feasibility study to examine the safety and effectiveness of using MindEx to provide the user an intuitive, efficient, and accurate ability to control multiple applications on a computer interface such as a word processor, a paint application, or to play simple video games. Such versatility could greatly improve the autonomy and quality of life of severely paralyzed individuals. Two subjects will be enrolled, each implanted with MindEx for a period of at least 53 weeks and up to 313 weeks. The study is expected to take at least one year and up to six years in total.","conditions":["Paralysis; Quadriplegic","Quadraplegia","Tetraplegia","Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis (ALS)","Brainstem Stroke","Paralysis","Brain-computer Interface","BCI"],"keywords":["spinal cord injury","brain-computer interface","brain-machine interface","paralysis","Quadriplegic","Quadraplegia","Tetraplegia","Cervical Spinal Cord Injury","Brainstem Stroke","ALS","BCI","BMI","Amyotrophic lateral sclerosis"],"interventions":[{"type":"DEVICE","name":"Mind Extender (MindEx)"}],"enrollment":2,"startDate":"2026-02-20","completionDate":"2030-05-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)\n* Provide informed consent\n* Understand and comply with instructions, if necessary, with the aid of a translator\n* Communicate via speech or other means\n* Surgical clearance\n* Life expectancy greater than 12 months\n* Travel to study locations up to five days per week for the duration of the study\n* Caregiver monitor for surgical site complications and behavioral changes on a daily basis\n* Psychosocial support system\n* Stable ventilator status\n\nExclusion Criteria:\n\n* Presence of memory problems\n* Intellectual impairment\n* Psychotic illness or chronic psychiatric disorder, including major depression if untreated\n* Poor visual acuity\n* Pregnancy\n* Active infection or unexplained fever\n* Scalp lesions or skin breakdown\n* HIV or AIDS infection\n* Active cancer or chemotherapy\n* Diabetes\n* Autonomic dysreflexia\n* History of seizure\n* Implanted hydrocephalus shunt\n* Prior cranioplasty\n* Other implanted devices\n* Medical conditions contraindicating surgery and chronic implantation of a medical device\n* Unable to undergo MRI or anticipated need for MRI during the study\n* Breastfeeding an infant (direct nursing or via a bottle of expressed milk)\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Suicidal ideation\n* Drug or alcohol dependence\n* Planning to become pregnant, or unwilling to use adequate birth control","locations":[{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Olivia Gibble, MS","phone":"214-648-8880","email":"Olivia.gibble@utsouthwestern.edu"},{"name":"Nader Pouratian, MD, PhD","phone":"214-645-5465","email":"nader.pouratian@utsouthwestern.edu"}],"primaryOutcomes":["Continuous trajectory decoding","Incidence of intervention-related adverse events","Competency in computer/tablet control","Efficacy of multiple brain regions for neural control over subsets of brain regions"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["dallas-texas"],"enrichment":{"headline":"Not a traditional drug phase: Mind Extender (MindEx) for Paralysis; Quadriplegic","inPlainEnglish":"This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer. This technology is named MindEx (for Mind Extender).","whoItsFor":["Ages 18 Years to 65 Years","Paralysis resulting from cervical spinal cord injury (SCI), brainstem stroke (ischemic or hemorrhagic), or amyotrophic lateral sclerosis (ALS)","Understand and comply with instructions, if necessary, with the aid of a translator","Communicate via speech or other means","Life expectancy greater than 12 months","Travel to study locations up to five days per week for the duration of the study","Caregiver monitor for surgical site complications and behavioral changes on a daily basis","Psychosocial support system"],"whoShouldSkip":["Presence of memory problems","Intellectual impairment","Psychotic illness or chronic psychiatric disorder, including major depression if untreated","Active infection or unexplained fever","Scalp lesions or skin breakdown","HIV or AIDS infection","Active cancer or chemotherapy"],"whatHappens":"If you join, the listed intervention(s) are Mind Extender (MindEx). The registry lists allocation as na. This research study is being done to develop a novel brain-computer interface (BCI) technology that can enable severely paralyzed individuals to interact with the world through direct brain-control of a computer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 2 people at Dallas. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.603Z"},{"nctId":"NCT05944016","title":"Phase 3 Clinical Trial With Dapagliflozin in Chronic Kidney Disease in Adolescents and Young Adult Patients","officialTitle":"DOUBLE PRO-TECT Alport: A Confirmatory, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess the Effect of Dapagliflozin on the Progression of Chronic Kidney Disease in Adolescents and Young Adult Patients With Alport Syndrome","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University Hospital Goettingen","sponsorClass":"OTHER","summary":"Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). These trials included no children. The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease. Preventing the rise of albuminuria by dapagliflozin would result in a very significant delay of end-stage kidney failure (ESKF) and improved quality of life. If successful, DOUBLE PRO-TECT Alport will change the treatment recommendations for children with CKD, who have a very high unmet medical need.","conditions":["Chronic Kidney Failure in Children and Young Adults"],"keywords":["chronic kidney disease in children","pediatric population","nephroprotective therapy in children","Alport syndrome","type IV collagen disease"],"interventions":[{"type":"DRUG","name":"Dapagliflozin"},{"type":"DRUG","name":"Placebo"}],"enrollment":102,"startDate":"2024-03-25","completionDate":"2027-09","sex":"ALL","minAge":"10 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Key inclusion criteria:\n\nEarly stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)\n\n* adolescents ≥ 10 to \\< 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND\n* eGFR ≥ 30 ml/min/1.73 m2 OR\n* adults ≥ 18 to \\< 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND\n* eGFR ≥ 60 ml/min/1.73 m2\n\n  1. Molecular-genetic diagnosis or diagnosis established by kidney biopsy\n  2. Stable RAS blockade as background therapy.\n  3. Signed and dated written informed consent.\n\nKey exclusion criteria:\n\n1. Medical history that might limit the individual's ability to take trial treatments.\n2. Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1.\n3. eGFR\\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation\n4. Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg).\n5. Known hypersensitivity or allergy to the investigational products.\n6. Any previous or current alcohol or drug abuse.\n7. Participation in another trial with an investigational drug ongoing.\n8. Women, who are nursing or pregnant, or who are not practicing an acceptable method of birth control.","locations":[{"facility":"Universitätsklinikum Heidelberg - Children","city":"Heidelberg","state":"Baden-Württenberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"LMU Klinikum","city":"München","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"v. Haunersches Kinderhospital","city":"München","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf - Adults","city":"Hamburg","state":"Free and Hanseatic City of Hamburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf - Children","city":"Hamburg","state":"Free and Hanseatic City of Hamburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clementine Kinderhospital","city":"Frankfurt am Main","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medicine Goettingen - Adults","city":"Göttingen","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medicine Goettingen - Childrens Hospital","city":"Göttingen","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Köln - Adults","city":"Cologne","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Köln - Children","city":"Cologne","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Münster - Adults","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster - Children","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Leipzig - Children","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Leipzig - Adults","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite Berlin - Adults","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite Berlin - Children","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Oliver Gross, MD","phone":"+4955139","email":"gross.oliver@med.uni-goettingen.de"}],"primaryOutcomes":["Primary endpoint"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":["dapagliflozin"],"locationSlugs":["heidelberg-germany","m-nchen-germany","hamburg-germany","frankfurt-am-main-germany","g-ttingen-germany","cologne-germany","m-nster-germany","leipzig-germany","berlin-germany"],"enrichment":{"headline":"Phase 3: testing Dapagliflozin for Chronic Kidney Failure in Children and Young Adults","inPlainEnglish":"Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD). The hypothesis of DOUBLE PRO-TECT Alport is to demonstrate superiority of the SGLT2i dapagliflozin in preventing progression of the chronic kidney disease Alport syndrome in children and young adults at early stages of disease.","whoItsFor":["Ages 10 Years to 39 Years","Early stages of CKD with established diagnosis of Alport syndrome at visit 1 (screening)","adolescents ≥ 10 to \\< 18 years with albuminuria (UACR ≥ 300mg/g creatinine) AND","eGFR ≥ 30 ml/min/1.73 m2 OR","adults ≥ 18 to \\< 40 years with albuminuria (UACR ≥ 500mg/g creatinine) AND","eGFR ≥ 60 ml/min/1.73 m2","Molecular-genetic diagnosis or diagnosis established by kidney biopsy","Stable RAS blockade as background therapy"],"whoShouldSkip":["Medical history that might limit the individual's ability to take trial treatments","Treatment with any SGLT2 inhibitor or within 4 weeks prior to Visit 1","eGFR\\<60 mL/min/1.73 m2 (CKD-EPI) or requiring dialysis or after kidney-transplantation","Uncontrolled arterial hypertension (blood pressure above 145/95 mmHg)","Known hypersensitivity or allergy to the investigational products","Any previous or current alcohol or drug abuse","Participation in another trial with an investigational drug ongoing"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin, or Placebo. The registry lists allocation as randomized. Recent trials have demonstrated positive renal outcomes of sodium-glucose co-transporter-2 inhibitors (SGLT2i) additive to angiotensin-converting-enzyme inhibitors (ACEis) in adult patients with diabetic and non-diabetic chronic kidney disease (CKD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 102 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.961Z"},{"nctId":"NCT05944692","title":"Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)","officialTitle":"Epilepsy Seizure Detection With Innovative Tripolar EEG (tEEG)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"CREmedical","sponsorClass":"INDUSTRY","summary":"Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.","conditions":["Epilepsy"],"keywords":["electroencephalography","tripolar electroencephalography (tEEG)","diagnostic accuracy"],"interventions":[{"type":"DEVICE","name":"Tripolar electroencephalography"}],"enrollment":90,"startDate":"2025-09-01","completionDate":"2027-12-31","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pediatric (BCH): Age ≥ 6 years and \\< 18 years\n* Adult (BNI): Age ≥ 18 years\n* Able to provide written informed consent or have a legally authorized representative able to provide consent; pediatric patients to provide assent when appropriate\n* Scheduled for routine outpatient EEG for clinical diagnosis\n* Able to participate in a post-EEG telemedicine video visit\n* Clinical diagnosis of epilepsy with epileptiform discharges on prior routine EEG\n* Scheduled for inpatient video-EEG monitoring for clinical diagnosis\n* MRI of brain available for co-registration\n* Confirmed diagnosis of focal epilepsy by prior video-EEG monitoring interpreted by board-certified epileptologist or clinical neurophysiologist\n* Scheduled for inpatient video-EEG monitoring with intracranial stereo-EEG electrodes for epilepsy presurgical evaluation\n* MRI of brain available for co-registration\n\nExclusion criteria\n\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data\n* Any clinical suspicion of prion disease\n* History of allergy or adverse reaction to EEG electrode paste or gel\n* Scalp lesions or infections\n* Severe intellectual disability or behavioral disorders with inability to cooperate with EEG application or recording","locations":[{"facility":"Barrow Neurological Institute Dignity Health dba St. Joseph's Hospital and Medical Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Walter Besio, PhD","phone":"4019326148","email":"walt@cremedical.com"}],"primaryOutcomes":["Technical and diagnostic accuracy"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Tripolar electroencephalography for Epilepsy","inPlainEnglish":"Concurrent electroencephalography (EEG) and new tripolar EEG (tEEG) will be recorded from adult and pediatric patients. In some patients stereo EEG (sEEG) will also be recorded concurrently.","whoItsFor":["Ages 6 Years to any","Pediatric (BCH): Age ≥ 6 years and \\< 18 years","Adult (BNI): Age ≥ 18 years","Scheduled for routine outpatient EEG for clinical diagnosis","Able to participate in a post-EEG telemedicine video visit","Clinical diagnosis of epilepsy with epileptiform discharges on prior routine EEG","Scheduled for inpatient video-EEG monitoring for clinical diagnosis","MRI of brain available for co-registration"],"whoShouldSkip":["Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the integrity of the data","Any clinical suspicion of prion disease","History of allergy or adverse reaction to EEG electrode paste or gel","Scalp lesions or infections","Severe intellectual disability or behavioral disorders with inability to cooperate with EEG application or recording"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 90 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.916Z"},{"nctId":"NCT05950282","title":"Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis","officialTitle":"Measuring Fasting Insulin and HOMA-IR by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ali Chappell","sponsorClass":"OTHER","summary":"The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, BMI, and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.","conditions":["Insulin Resistance","Polycystic Ovary Syndrome","Hyperinsulinism","Obesity","Metabolic Syndrome"],"keywords":["PCOS","Hyperinsulinemia","Insulin Resistance","Metabolic Syndrome","Obesity","Type 2 Diabetes"],"interventions":[],"enrollment":150,"startDate":"2024-02-01","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria Age: Participants aged 18+ years Sex: Both males and females Race/Ethnicity: Participants from diverse racial and ethnic backgrounds BMI: Participants across a range of body mass index (BMI) values PCOS Diagnosis: Participants with and without a confirmed diagnosis of PCOS based on established diagnostic criteria\n\nParticipants must have completed metabolic testing within one month prior to enrollment, including:\n\n* Fasting insulin\n* Hemoglobin A1c (A1c)\n* Complete lipid panel\n* Triglycerides Laboratory testing must be completed through a healthcare provider, an independent laboratory, or by using an Insara Insulin Testing Kit Laboratory values must be obtained following a minimum 8-hour fast Participants must have complete laboratory data for all required measures\n\nExclusion Criteria Age: Participants below 18 years Sex: None. Both males and females are included Race/Ethnicity: None. Participants from all racial and ethnic backgrounds are included Endocrine Disorders: Participants with other endocrine disorders affecting insulin levels (e.g., insulin-secreting tumors) Significant recent weight change: Loss of more than 5% of body weight within the previous month Pregnancy or breastfeeding Acute illness or infection within the past 2 weeks Use of medications known to significantly affect insulin or glucose metabolism will be recorded and accounted for in analysis","locations":[{"facility":"Lilli Health","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ali M Chappell, PhD, MS, RD","phone":"4092070443","email":"research@insara.com"}],"primaryOutcomes":["Assessment of Fasting Insulin levels and HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) scores among different groups stratified by age, sex, race/ethnicity, BMI, and PCOS (Polycystic Ovary Syndrome) diagnosis."],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity","pcos"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Determinants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis","inPlainEnglish":"The study aims to investigate the relationship between fasting insulin and Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) across various demographic factors, including age, sex, race/ethnicity, body-mass index (BMI), and polycystic ovary syndrome (PCOS) diagnosis. By analyzing these variables, the study seeks to identify potential variations in insulin levels, which could provide valuable insights into the impact of different factors on metabolic health and the development of insulin-related conditions.","whoItsFor":["Ages 18 Years to any","Participants must have completed metabolic testing within one month prior to enrollment, including:","Hemoglobin A1c (A1c)","Complete lipid panel"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Houston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.799Z"},{"nctId":"NCT05962177","title":"Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic","officialTitle":"Montpellier PROspective Cohort in Relapsing Remitting Multiple Sclerosis Using Imaging and Serologic","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Montpellier","sponsorClass":"OTHER","summary":"Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments. Indeed, the introduction, about 10 years ago, of high efficacy treatments (HET) has changed the management of the disease and a significant proportion of patients not controlled by medium efficacy treatments (MET) of the disease are now stable on HET. Nevertheless, if their short-term efficacy has been clearly demonstrated, it remains important to be able to confirm the superiority of HET over MET with the help of prospective cohorts (thus ensuring a retention of patients \\> 90% over the long term) analyzing all clinical and imaging biomarkers, imaging and biological data.\n\nThe measurement of cerebral atrophy and its progression is probably one of the most interesting and most easily used biomarkers that can be used clinically to assess this silent progression in these groups of patients.\n\nThe progression of brain atrophy is also dependent on many other non-modifiable but also modifiable factors outside of MS that need to be better evaluated and eventually managed.\n\nNevertheless, the existence of various neurological comorbidities (sleep disorders, headaches) on this atrophy has not been specifically analyzed to date. The functional assessments used in routine follow-up are most often performed in a care facility and have many limitations: lack of reproducibility, inter/intra operator variability, poor correlation with functional and quality of life scales, etc.\n\nIt is therefore extremely important to be able to identify new clinical biomarkers of disease progression of the disease by evaluating the physical capacities of the patients as precisely as possible.\n\nThis study is a single-center, prospective cohort study of a population of 400 patients with relapsing remitting MS (RRMS).\n\nThe main objective of this study is to compare, on morphological imaging criteria (T1 volumetry), the progression of brain atrophy (biomarker of disease progression) at 3 years in RRMS patients according to treatment line (MET vs HET).","conditions":["Multiple Sclerosis"],"keywords":["Multiple sclerosis","MRI","Longitudinal cohort","Real life","Biomarkers"],"interventions":[{"type":"OTHER","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Blood withdrawal"},{"type":"OTHER","name":"Neuropsychological tests"}],"enrollment":400,"startDate":"2023-09-11","completionDate":"2030-06","sex":"ALL","minAge":"18 Years","maxAge":"59 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients over 18 and under 60 years of age\n* Patients with Relapsing-remitting MS without relapse for at least 6 months\n* EDSS\\<6 at time of inclusion\n\nExclusion Criteria:\n\n* Secondary progressive MS or Primary progressive MS at time of inclusion\n* Evidence of disease progression (clinical or radiological)\n* Change in treatment within 6 months prior to inclusion\n* Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.)\n* Inability to follow the follow-up planned by the study\n* Pregnant or breastfeeding women\n* Patient not affiliated to the social security system or not benefiting from such a system\n* Adult protected by law or patient under guardianship or curatorship\n* Failure to obtain written informed consent after a reflection period","locations":[{"facility":"Neurology Department, Hopital Gui de Chauliac","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xavier AYRIGNAC, Medical Doctor","phone":"0467337202","email":"x-ayrignac@chu-montpellier.fr"}],"primaryOutcomes":["Total brain atrophy"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["montpellier-france"],"enrichment":{"headline":"Not a traditional drug phase: Magnetic Resonance Imaging for Multiple Sclerosis","inPlainEnglish":"Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease. Nevertheless, due to an initial recruitment carried out in the years 2000-2010, they do not constitute a faithful representation of the patients followed in clinical routine, in particular in terms of distribution of treatments.","whoItsFor":["Ages 18 Years to 59 Years","Patients over 18 and under 60 years of age","Patients with Relapsing-remitting MS without relapse for at least 6 months","EDSS\\<6 at time of inclusion"],"whoShouldSkip":["Secondary progressive MS or Primary progressive MS at time of inclusion","Evidence of disease progression (clinical or radiological)","Change in treatment within 6 months prior to inclusion","Subject with a contraindication to MRI (claustrophobia, pacemaker, etc.)","Inability to follow the follow-up planned by the study","Pregnant or breastfeeding women","Patient not affiliated to the social security system or not benefiting from such a system"],"whatHappens":"If you join, the listed intervention(s) are Magnetic Resonance Imaging, Blood withdrawal, or Neuropsychological tests. The registry lists allocation as randomized. Several prospective monocentric cohorts of between 250 and 1000 patients have been set up in order to characterize more precisely the evolution of the disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at Montpellier. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.996Z"},{"nctId":"NCT05964101","title":"Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma","officialTitle":"Neoadjuvant Anti-PD-1 Drug Nivolumab Combined With Chemotherapy in the Treatment of Primary Tracheal Squamous Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","sponsorClass":"OTHER","summary":"This is a single-arm, open, II phase study to evaluate the safety and efficacy of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.","conditions":["Neoplasms","Carcinoma, Squamous","Antineoplastic Agents"],"keywords":["tracheal tumor","neoadjuvant immunochemotherapy","surgery"],"interventions":[{"type":"DRUG","name":"Nivolumab Injection [Opdivo]"}],"enrollment":25,"startDate":"2023-08-15","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination\n2. PET-CT confirmed no metastasis;\n3. ECOG physical status score 0-1;\n4. Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy.\n5. Age ≥ 18 years;\n6. Have one measurable lesion at least;\n7. Good function of other major organs (liver, kidney, blood system, etc.):-absolute neutrophil count ((ANC) ≥ 1.5 × 109), platelet (≥ 100 × 109), hemoglobin (≥ 90g/L). Note: patients shall not receive blood transfusion or growth factor support within 14 days before blood collection during the screening period;-International standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 × normal upper limit (ULN);-activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;- serum total bilirubin ≤ 1.5 × ULN (Gilbert syndrome patients with total bilirubin must be \\< 3×ULN). Fertile female patients with aspartate and alanine aminotransferase (AST and ALT) ≤ 2.5 × ULN, or liver metastasis with AST and ALT ≤ 5 × ULN\n8. Fertile female patients must voluntarily take effective contraceptive measures more than 120 days after chemotherapy or the last administration of Nivolumab, whichever is later, and the urine or serum pregnancy test results less than 7 days before entering the group were negative. Unsterilized male patients must voluntarily take effective contraceptive measures ≥ 120 days after chemotherapy or the last administration of Nivolumab, whichever is the latter.\n9. Sign informed consent;\n\nExclusion Criteria:\n\n1. Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;\n2. Patients with other malignant tumors in the five years before the start of this trial.\n3. Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure \\[higher than II (New York College of Cardiology)\\], severe arrhythmias, liver, kidney or metabolic diseases;\n4. Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;\n5. A history of active bleeding or embolism within 6 months, or received thrombolysis or anticoagulation therapy, or the researchers believe that there is an obvious tendency of gastrointestinal bleeding (such as esophageal varices have the risk of bleeding, local active ulcer lesions, etc.);\n6. Had is suffering from nephrotic syndrome\n7. Allergic to experimental drugs;\n8. Complicated with HIV infection or active hepatitis.\n9. Vaccination within 4 weeks before the start of this trial;\n10. Those who had undergone other major operations or severe injuries within the previous 2 months;\n11. Clinically uncontrolled pleural effusion or ascites requiring pleural or abdominal puncture drainage within 2 weeks before admission;\n12. Pregnant or lactating women;\n13. Those with neurological diseases or mental disorders.\n14. Participated in another therapeutic clinical study at the same time;\n15. Other researchers did not consider it appropriate to enroll in the group.","locations":[{"facility":"The First Affiliated Hospital of Guangzhou Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shuben Li, PhD","phone":"+8613500030280","email":"13500030280@163.com"}],"primaryOutcomes":["Safety: frequency of severe adverse events","R0 rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["nivolumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: testing Nivolumab Injection [Opdivo] for Neoplasms","inPlainEnglish":"This is a single-arm, open, II phase study to measure the safety and how well it works of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.","whoItsFor":["Ages 18 Years to 75 Years","Bronchoscopic biopsy confirmed as tracheal squamous cell carcinoma by pathological examination","PET-CT confirmed no metastasis;","ECOG physical status score 0-1;","Bronchoscopy, and chest CT is evaluated as early or locally advanced tracheal malignant tumor, and radical surgery is expected to be feasible or after neoadjuvant therapy","Have one measurable lesion at least;"],"whoShouldSkip":["Any Chinese herbal medicine used to control cancer was used within 14 days before the first administration of the study drug;","Patients with other malignant tumors in the five years before the start of this trial","Complicated with unstable systemic diseases, including active infections, uncontrolled hypertension, unstable angina pectoris, congestive heart failure \\[higher than II (New York College of Cardiology)\\], severe arrhythmias, liver, kidney or metabolic diseases;","Active, known or suspected autoimmune diseases, or autoimmune paraneoplastic syndrome requiring systemic treatment;","Had is suffering from nephrotic syndrome","Allergic to experimental drugs;","Complicated with HIV infection or active hepatitis"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab Injection [Opdivo]. The registry lists allocation as na. This is a single-arm, open, II phase study to measure the safety and how well it works of Nivolumab + carboplatin + paclitaxel in 25 newly diagnosed patients with primary tracheal squamous cell carcinoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 25 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.331Z"},{"nctId":"NCT05965180","title":"Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe","officialTitle":"Interstitial Assessment of Architectural Heterogeneity in Prostate Cancer Using a Fine Needle Photoacoustic Probe","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Michigan Rogel Cancer Center","sponsorClass":"OTHER","summary":"In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe. When inserted into the prostate, the fine needle PA probe will assess the histological information in its surrounding tissue without any tissue extraction. The needle probe has been tested in prostate tissue samples and whole human prostates ex vivo.","conditions":["Prostate Cancer"],"keywords":["Biopsy"],"interventions":[{"type":"DEVICE","name":"Fine Needle Photoacoustic Probe"}],"enrollment":50,"startDate":"2023-10-16","completionDate":"2027-10","sex":"MALE","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\) Planned prostate biopsy as part of routine clinical care\n* 2\\) \\> 40 and \\<80 years old\n\nExclusion Criteria:\n\n* 1\\) Known history of bleeding disorders or\n* 2\\) Patients taking anticoagulants, no matter doses or washout time\n* 3\\) Known allergy to silicone material\n* 4\\) Unable to provide informed consent\n* 5\\) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded\n* 6\\) Involved in other investigational studies.","locations":[{"facility":"University of Michigan Rogel Cancer Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cancer AnswerLine","phone":"1-800-865-1125","email":"CancerAnswerLine@med.umich.edu"}],"primaryOutcomes":["Demonstration of reliable measurements"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Fine Needle Photoacoustic Probe for Prostate Cancer","inPlainEnglish":"In this project, we will integrate the Photoacoustic (PA) technology into a prostate biopsy procedure through a fine needle probe. The needle probe will be in the shape of a biopsy needle and compatible with the needle insertion mechanism in the transrectal ultrasound (TRUS) probe.","whoItsFor":["Ages 40 Years to 80 Years","Men only","1\\) Planned prostate biopsy as part of routine clinical care","2\\) \\> 40 and \\<80 years old"],"whoShouldSkip":["1\\) Known history of bleeding disorders or","2\\) Patients taking anticoagulants, no matter doses or washout time","3\\) Known allergy to silicone material","5\\) Either the surgeon or the patient do not think the patient will not be able to complete all parts of the study, the patient will be excluded","6\\) Involved in other investigational studies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at Ann Arbor. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.314Z"},{"nctId":"NCT05969860","title":"At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer","officialTitle":"Cancer CARE Beyond Walls - A Pilot of a Randomized, Pragmatic Trial of Cancer Directed Therapy Administration in the Patients' Homes Versus in Clinic","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings. This separation adds to the physical, emotional, social, and financial burden for patients and their families. The logistics and costs of navigating cancer treatments have become a principal contributor to patients' reduced quality of life. It is therefore important to reduce the burden of cancer in the lives of patients and their caregivers, and a vital aspect of this involves moving beyond traditional hospital and clinic-based care and evaluate innovative care delivery models with virtual capabilities. Providing cancer treatment at-home, versus in the clinic, may help reduce psychological and financial distress and increase treatment compliance, especially for marginalized patients and communities.","conditions":["Advanced Anal Carcinoma","Advanced Biliary Tract Carcinoma","Advanced Bladder Carcinoma","Advanced Breast Carcinoma","Advanced Carcinoid Tumor","Advanced Cervical Carcinoma","Advanced Colorectal Carcinoma","Advanced Gastric Carcinoma","Advanced Glioblastoma","Advanced Head and Neck Carcinoma","Advanced HER2 Positive Breast Carcinoma","Advanced Lung Carcinoma","Advanced Lung Small Cell Carcinoma","Advanced Malignant Germ Cell Tumor","Advanced Malignant Solid Neoplasm","Advanced Neuroendocrine Carcinoma","Advanced Ovarian Carcinoma","Advanced Pancreatic Carcinoma","Advanced Prostate Small Cell Neuroendocrine Carcinoma","Advanced Prostate Carcinoma","Hematopoietic and Lymphoid System Neoplasm","Multiple Myeloma","Myelodysplastic Syndrome","Advanced Basal Cell Carcinoma","Advanced Cholangiocarcinoma","Advanced Endometrial Carcinoma","Advanced Esophageal Carcinoma","Advanced Fallopian Tube Carcinoma","Advanced Hepatocellular Carcinoma","Advanced Liver Carcinoma","Advanced Lymphoma","Advanced Malignant Testicular Neoplasm","Advanced Melanoma","Advanced Merkel Cell Carcinoma","Advanced Penile Carcinoma","Advanced Primary Malignant Central Nervous System Neoplasm","Advanced Renal Cell Carcinoma","Advanced Sarcoma","Advanced Skin Squamous Cell Carcinoma","Advanced Urethral Carcinoma","Advanced Vaginal Carcinoma","Advanced Vulvar Carcinoma","Advanced Appendix Carcinoma","Advanced Gastroesophageal Junction Adenocarcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Clinical Encounter"},{"type":"OTHER","name":"Home Health Encounter"},{"type":"OTHER","name":"Quality-of-Life Assessment"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":220,"startDate":"2023-09-21","completionDate":"2027-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required.\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines.\n\n  * Note, patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Patients may receive any combination of any above listed medications or regimens:\n  * Eligible disease cancer types:\n\n    * Anal cancer\n    * Appendiceal carcinoma\n    * Basal cell carcinoma\n    * Bladder cancer\n    * Biliary cancer\n    * Breast cancer\n    * Central Nervous System malignancy including glioblastoma\n    * Cervical cancer\n    * Cholangiocarcinoma\n    * Colorectal carcinoma\n    * Endometrial cancer\n    * Fallopian tube cancer\n    * Gastroesophageal cancer \\[including gastric, esophageal, and gastroesophageal junction (GEJ) cancers\\]\n    * Germ cell carcinoma\n    * Head and Neck cancer\n    * Hepatocellular Carcinoma\n    * Liver\n    * Lung\n    * Lymphoma\n    * Melanoma\n    * Merkel Cell\n    * Multiple Myeloma\n    * Myelodysplastic syndrome\n    * Myeloid Disorders\n    * Neuroendocrine carcinoma\n    * Ovarian cancer\n    * Pancreatic adenocarcinoma\n    * Penile carcinoma\n    * Peritoneal carcinoma\n    * Prostate cancer\n    * Renal cell cancer\n    * Sarcoma\n    * Squamous cell Carcinoma of the Skin\n    * Testicular cancer\n    * Urethral carcinoma\n    * Vaginal carcinoma\n    * Vulvar carcinoma\n  * Eligible Regimens\n\n    * Fluorouracil (5-FU) +/- leucovorin +/- bevacizumab +/- trastuzumab\n    * 5FU +/- leucovorin +/- bevacizumab +/- nivolumab\n    * Atezolizumab +/- bevacizumab\n    * Atezolizumab +/- bevacizumab + cobimetinib, atezolizumab +/- bevacizumab + vemurafenib, atezolizumab +/- bevacizumab + cobimetinib + vemurafenib\n    * Avelumab\n    * Avelumab + axitinib\n    * Bevacizumab\n    * Bevacizumab + capecitabine\n    * Bevacizumab + irinotecan (+/- capecitabine)\n    * Bevacizumab + olaparib, bevacizumab + lenvatinib, bevacizumab + niraparib, bevacizumab + rucaparib\n    * Bevacizumab + Temozolomide, Bevacizumab + Lomustine, or Bevacizumab + everolimus\n    * Bevacizumab + trifluridine/tipiracil\n    * Bortezomib\n    * Bortezomib + cyclophosphamide, bortezomib + lenalidomide, bortezomib + pomalidomide, bortezomib + selinexor\n    * Bortezomib + venetoclax\n    * Carfilzomib\n    * Carfilzomib + cyclophosphamide, carfilzomib + lenalidomide, carfilzomib + pomalidomide, carfilzomib + selinexor\n    * Carfilzomib + venetoclax\n    * Cemiplimab\n    * Cisplatin\n    * Cisplatin/5-FU\n    * Cisplatin/etoposide\n    * Cisplatin + durvalumab\n    * Cisplatin + gemcitabine\n    * Cisplatin + gemcitabine + durvalumab\n    * Daratumumab (+ oral \\[PO\\] cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + bortezomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Daratumumab + carfilzomib (+ PO cyclophosphamide, lenalidomide, pomalidomide, or selinexor)\n    * Degarelix\n    * Durvalumab\n    * Durvalumab + tremelimumab\n    * Eribulin\n    * FOLFIRI +/- bevacizumab (5FU +/- leucovorin + irinotecan)\n    * Fam-trastuzumab deruxtecan\n    * Fulvestrant\n    * Fulvestrant + ribociclib, fulvestrant + abemaciclib, fulvestrant + palbociclib, fulvestrant + alpelisib, or fulvestrant + capivasertib\n    * Gemcitabine\n    * Gemcitabine + durvalumab\n    * Gemcitabine + paclitaxel protein-bound\n    * Goserelin acetate\n    * Irinotecan\n    * Irinotecan + capecitabine\n    * Lanreotide\n    * Leuprolide\n    * Nivolumab\n    * Nivolumab + cabozantinib\n    * Nivolumab-relatlimab\n    * Octreotide\n    * Paclitaxel\n    * Pembrolizumab\n    * Pembrolizumab + axitinib, pembrolizumab + lenvatinib, pembrolizumab + capecitabine, pembrolizumab + dabrafenib +/- trametinib, pembrolizumab + trametinib)\n    * Pemetrexed\n    * Pertuzumab\n    * Pemetrexed + pembrolizumab\n    * Rituximab\n    * Trastuzumab + paclitaxel\n    * Trastuzumab with or without pertuzumab maintenance (SQ or IV) (+/- tucatinib +/- capecitabine)\n    * Decitabine\n    * These regimens can be used only if patients are receiving one of the regimens above:\n\n      * Darbepoetin-alfa\n      * Epoetin\n      * Filgrastim\n* Note: Female or male patients with histologically confirmed malignancy who are currently receiving treatment with one of the above eligible regimens may receive supportive care medications for treatment or prevention of bone metastases, including agents such as:\n\n  * Zoledronic acid\n  * Denosumab\n* Patient has had adequate tolerability of their clinical standard of care cancer treatment in the opinion of their treating physician and no drug-related infusion reactions prior to consent\n* Patients who according to documentation from their treating provider plan to continue the treatment regimen they are currently prescribed for at least 24 weeks from the start of cycle following randomization.\n* Residing within the area serviced by supplier and paramedic network\n* Residence has wireless fidelity (wifi) to enable a reliable connection with the remote Command Center or it is suitable for connection through a wireless network solution\n* Age \\>= 18 years at time of registration\n* Signed informed consent form by patient\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2\n* Ability to complete questionnaire(s) by themselves or with assistance\n* RANDOMIZATION ELIGIBILITY CRITERIA: In addition to the criteria above, confirmation by the CCBW Command Center that the patient has adequate tolerability to the standard of care cancer therapy and no drug-related infusion reactions since pre-registration and prior to registration\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm. Note: Patients are permitted concomitant standard of care oral drugs such as ribociclib, abemaciclib, or palbociclib in combination with endocrine therapy (e.g., Leuprolide, fulvestrant intramuscular \\[IM\\], etc.); tucatinib and capecitabine in combination with trastuzumab and pertuzumab for HER2 positive breast cancer; dexamethasone, cyclophosphamide, lenalidomide or pomalidomide for multiple myeloma; temozolomide, lomustine, or afinitor in combination with avastin for glioblastoma. In addition, all oral anti-hormonal agents for breast and prostate cancer are permitted (e.g., tamoxifen, arimidex, abiraterone, etc.) if used in combination with any of the drugs\n* Requiring 24/7 assistance with activities of daily living (ADLs)\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction =\\< 6 months\n  * Wound healing disorder\n  * Or psychiatric illness/social situations that would limit compliance with study requirements","locations":[{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altru Cancer Center","city":"Grand Forks","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Mean patient-reported rating of Cancer Connected Access and Remote Expertise"],"hasResults":false,"conditionSlugs":["melanoma","glioblastoma","lymphoma","multiple-myeloma","kidney-cancer","liver-cancer","als"],"drugSlugs":[],"locationSlugs":["jacksonville-florida","grand-forks-north-dakota"],"enrichment":{"headline":"Phase 2: Clinical Encounter for Advanced Anal Carcinoma","inPlainEnglish":"This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Currently most drug-related cancer care is conducted in infusion centers or specialty hospitals, where patients spend many hours a day isolated from family, friends, and familiar surroundings.","whoItsFor":["Ages 18 Years to any","Female or male patients with histologically confirmed malignancy. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis along; histologic confirmation is not required","Eligible disease cancer types:","Appendiceal carcinoma","Basal cell carcinoma","Central Nervous System malignancy including glioblastoma","Colorectal carcinoma","Fallopian tube cancer"],"whoShouldSkip":["Requiring 24/7 assistance with activities of daily living (ADLs)","Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)","Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens","Uncontrolled intercurrent illness including, but not limited to:","Ongoing or active infection","Symptomatic congestive heart failure","Unstable angina pectoris"],"whatHappens":"If you join, the listed intervention(s) are Clinical Encounter, Home Health Encounter, or Quality-of-Life Assessment. The registry lists allocation as randomized. This clinical trial studies the effect of cancer directed therapy given at-home versus in the clinic for patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 220 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.080Z"},{"nctId":"NCT05971732","title":"The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)","officialTitle":"The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"China-Japan Friendship Hospital","sponsorClass":"OTHER","summary":"This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.","conditions":["Heart Failure With Reduced Ejection Fraction","Iron Deficiency","Acute Heart Failure"],"keywords":["Exercise capacity","Quality of life","Acute Heart Failure"],"interventions":[{"type":"DRUG","name":"Ferric derisomaltose"},{"type":"DRUG","name":"Placebo"}],"enrollment":146,"startDate":"2023-08-01","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \\<50% before randomization.\n3. Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.\n4. Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:\n\n   1. Systolic blood pressure≥100mmHg, without symptoms of hypotension;\n   2. Stop using intravenous diuretics;\n   3. Neither intravenous inotropic drugs or vasodilators were used (including nitrates).\n5. Subject is iron deficient defined as serum ferritin \\<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \\<20%.\n6. Able and willing to provide informed consent and accomplish 6 minutes-walking test.\n\nExclusion Criteria:\n\n1. Hematological criteria: ferritin \\>400 ug/L; hemoglobin \\<9.0, hemoglobin \\>13.5 g/dL in women or \\>14.5 g/dL in men.\n2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15ml/min/1.73m2\n3. Body weight \\<35kg at randomization.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)\n6. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).\n7. Non-iron deficiency anaemia.\n8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.\n9. Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.\n10. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate\\> 100 beats / min at rest).\n11. Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST \\> 3x upper limit of normal.\n12. Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.\n13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.\n14. Baseline 6 minutes-walking distance\\>500m.\n15. Treated with long-term oral high-dose or steroid-immunosuppression therapy.\n16. Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).\n17. Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.\n18. Untreated hypothyroidism.\n19. Currently enrolled in any other investigational device or drug study \\<30 days prior to screening, or received other investigational agent(s).","locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ying Zhou, Dr","phone":"+86-13699164283","email":"929352903@qq.com"},{"name":"Peizhao Li, Dr","phone":"+86-18443151740","email":"lipz7014@163.com"}],"primaryOutcomes":["Change in 6-minute walking distance"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 4: testing Ferric derisomaltose for Heart Failure With Reduced Ejection Fraction","inPlainEnglish":"This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as dummy treatment (placebo).","whoItsFor":["Ages 18 Years to any","Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \\<50% before randomization","Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV","Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:","Systolic blood pressure≥100mmHg, without symptoms of hypotension;","Stop using intravenous diuretics;","Neither intravenous inotropic drugs or vasodilators were used (including nitrates)","Subject is iron deficient defined as serum ferritin \\<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \\<20%"],"whoShouldSkip":["Hematological criteria: ferritin \\>400 ug/L; hemoglobin \\<9.0, hemoglobin \\>13.5 g/dL in women or \\>14.5 g/dL in men","Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15ml/min/1.73m2","Body weight \\<35kg at randomization","Heart failure was secondary to valvular diseases or congenital heart diseases","History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)","Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment))","Non-iron deficiency anaemia"],"whatHappens":"If you join, the listed intervention(s) are Ferric derisomaltose, or Placebo. The registry lists allocation as randomized. This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 146 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.432Z"},{"nctId":"NCT05972291","title":"Mechanisms of Gulf War Illness","officialTitle":"Mechanisms of Gulf War Illness","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans. Our proposed studies will provide an innovative and novel treatment trial for chronic gastrointestinal symptoms in veterans with Gulf War Illness that were deployed into war zones. Given that there are currently no specific treatments for these disorders, and that current symptomatic approaches are far from ideal, proof of principle of our trial would be an extremely important advance as it would not only have a beneficial impact on the health of many thousands of our veterans, but also it would substantially reduce the many negative economic effects of this ailment on the VA Health Care System.","conditions":["Gulf War Illness","Irritable Bowel Syndrome","Gastrointestinal Symptoms"],"keywords":["gastrointestinal","irritable bowel syndrome","glutamine"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Oral Glutamine"},{"type":"OTHER","name":"Control Arm"}],"enrollment":80,"startDate":"2023-10-16","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf\n2. Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating)\n3. increased intestinal permeability on the lactulose/mannitol permeability test (ratio \\>0.07)\n4. able and willing to cooperate with the study\n\nExclusion Criteria:\n\n1. current participation in another research protocol or unable to give informed consent\n2. women with a positive urine pregnancy test or breastfeeding\n3. history of inflammatory bowel disease, lactose intolerance and/or celiac sprue\n4. \\+ hydrogen breath test for bacterial overgrowth\n5. \\+ anti-endomysial antibody titer\n6. use of NSAIDs 2 weeks before or during the study\n7. known allergy to glutamine or whey protein\n8. abdominal surgery except for removal of gallbladder, uterus, or appendix \\>6 months prior to entry into the study\n9. Abnormal serum BUN and/or creatinine\n10. Mannitol recovery out of the normal range of 5-25 U/g\n11. history of kidney disease\n12. allergies to monosodium glutamate\n13. current use of anti-seizure medications","locations":[{"facility":"Memphis VA Medical Center, Memphis, TN","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"George N Verne","phone":"(901) 523-8990","email":"George.Verne@va.gov"},{"name":"QiQi Zhou, MD PhD","phone":"(901) 523-8990","email":"qiqi.zhou@va.gov"}],"primaryOutcomes":["To determine if oral glutamine supplementation will improve the Symptom Severity Scale in Veterans with GWI and chronic GI Symptoms.","To determine if oral glutamine supplementation will restore intestinal permeability in Veterans with GWI."],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["memphis-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: Oral Glutamine for Gulf War Illness","inPlainEnglish":"Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf. The pathophysiologic mechanisms of these chronic gastrointestinal symptoms are not well understood but cause significant morbidity in veterans.","whoItsFor":["Ages 18 Years to 65 Years","Veterans 18-65 years old with GWI and chronic GI symptoms (abdominal pain, diarrhea, bloating) that started during their deployment in the Persian Gulf","increased intestinal permeability on the lactulose/mannitol permeability test (ratio \\>0.07)","able and willing to cooperate with the study"],"whoShouldSkip":["women with a positive urine pregnancy test or breastfeeding","history of inflammatory bowel disease, lactose intolerance and/or celiac sprue","\\+ hydrogen breath test for bacterial overgrowth","\\+ anti-endomysial antibody titer","use of NSAIDs 2 weeks before or during the study","known allergy to glutamine or whey protein","abdominal surgery except for removal of gallbladder, uterus, or appendix \\>6 months prior to entry into the study"],"whatHappens":"If you join, the listed intervention(s) are Oral Glutamine, or Control Arm. The registry lists allocation as randomized. Many veterans with Gulf War Illness developed chronic gastrointestinal symptoms during their deployment to the Persian Gulf.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Memphis. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.440Z"},{"nctId":"NCT05972317","title":"IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial","officialTitle":"IBS Personalized Diet vs. Low FODMAP Diet Randomized Control Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Weizmann Institute of Science","sponsorClass":"OTHER","summary":"Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease. However, the characteristics and functions of these metabolites remain unknown to date. This placebo-controlled interventional study examines person-specific small molecules and bacteria driving IBS and their downstream effects on the human gut epithelium.","conditions":["Irritable Bowel Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Standard Low FODMAP dietary regimen"},{"type":"OTHER","name":"personalized low FODMAP dietary regimen"}],"enrollment":30,"startDate":"2026-05-11","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male and Female\n* Age - 18-70\n\nExclusion Criteria:\n\n* Consumption of antibiotics 2 months prior to enrolment.\n* Consumption of probiotic supplements 2 weeks prior to enrolment.\n* Type 1 or type 2 diabetes diagnosis.\n* Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the study.\n* Chronic disease - to the discretion of the study medical team.\n* Cancer and recent anticancer treatment.\n* Immunosuppression.\n* Psychiatric disorders - to the discretion of the medical team\n* History of gastrointestinal surgeries - to the discretion of the medical team\n* Inflammatory bowel diseases or gastrointestinal disorders - to the discretion of the medical team\n* Unstable doses of medications in the past 2 months\n* Alcohol or substance abuse.","locations":[{"facility":"Weizmann institute of science","city":"Rehovot","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yotam Cohen","phone":"+97289529173","email":"Yotam.cohen@weizmann.ac.il"},{"name":"Shimrit Eliyahu Miller","phone":"","email":"shimrit.miller@weizmann.ac.il"}],"primaryOutcomes":["Stool microbiome composition"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["rehovot-israel"],"enrichment":{"headline":"Not a traditional drug phase: Standard Low FODMAP dietary regimen for Irritable Bowel Syndrome","inPlainEnglish":"Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans. Alterations in the gut microbiome are at the center of IBS, and microbiome-induced volatile metabolites in response to dietary exposures is believed to drive a downstream impact on susceptible hosts, thereby driving the disease.","whoItsFor":["Ages 18 Years to 70 Years"],"whoShouldSkip":["Consumption of antibiotics 2 months prior to enrolment","Consumption of probiotic supplements 2 weeks prior to enrolment","Type 1 or type 2 diabetes diagnosis","Pregnancy, fertility treatments, breastfeeding 3 months prior to the first day of the study","Chronic disease - to the discretion of the study medical team","Cancer and recent anticancer treatment","Psychiatric disorders - to the discretion of the medical team"],"whatHappens":"If you join, the listed intervention(s) are Standard Low FODMAP dietary regimen, or personalized low FODMAP dietary regimen. The registry lists allocation as randomized. Irritable bowel syndrome (IBS) is considered the most common gastrointestinal disorder in humans, with an estimated global prevalence of 11%-20% of all humans.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Rehovot. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.433Z"},{"nctId":"NCT05972564","title":"The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function","officialTitle":"The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Vanderbilt University Medical Center","sponsorClass":"OTHER","summary":"Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions. This trial will determine both the anti-inflammatory potential of the SGLT2 inhibitor empagliflozin, and the contribution of adipose inflammation to surrogate measures of cardiovascular disease in a randomized controlled trial of obese patients.","conditions":["Obesity","Metabolic Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 25 MG"},{"type":"DRUG","name":"Placebo"}],"enrollment":74,"startDate":"2023-09-06","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\. Age 18+ years old 2. Metabolic syndrome as defined by 3 or more of 5 criteria:\n\n1. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month\n2. Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)\n3. High-density lipoprotein (HDL) \\< 40 mg/dL in males or \\< 50 mg/dL in females\n4. Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications\n5. Waist circumference ≥ 102 cm in males or ≥ 88cm in females 3. BMI ≥ 35 kg/M2 4. The ability to provide informed consent\n\n   Exclusion Criteria:\n\n   6\\. Type 1 diabetes. 7. Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%. 8. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month.\n\n   9\\. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months.\n\n   10\\. Treatment with an SGLT2 inhibitor in the last 3 months. 11. Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone surgical sterilization or to be using an intra-uterine device, hormonal contraceptive, or barrier methods of birth control.\n\n   12\\. Cardiovascular disease such as myocardial infarction within six months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (left ventricular hypertrophy acceptable), deep vein thrombosis, pulmonary embolism, -second- or third-degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy 13. Presence of implanted cardiac defibrillator or pacemaker 14. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack 15. History of pancreatitis or pancreatic surgery 16. History or presence of immunological or hematological disorders 17. Clinically significant gastrointestinal impairment that could interfere with drug absorption 18. History of advanced liver disease with cirrhosis 19. Individuals with an eGFR\\<45 mL/min/1.73 m2, where eGFR is determined by the four-variable Modification of Diet in Renal Disease (MDRD) equation, where serum creatinine is expressed in mg/dL and age in years: eGFR (mL/min/1.73m2)=186 • Scr-1.154 • age-0.203 • (0.742 if female) 20. Treatment with chronic systemic glucocorticoid therapy (more than 7 consecutive days in 1 month) 21. Treatment with anticoagulants 22. Any underlying or acute disease requiring regular medication which could possibly pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult 23. History of alcohol abuse (\\>14 per week for men and \\>7 per week for women) or illicit drug use 24. Treatment with any investigational drug in the one month preceding the study 25. Previous randomization in this trial 26. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study 27. Inability to comply with the protocol in the opinion of the principal investigator, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study\n\n   Criteria Related to Known Adverse Effects of Drug:\n\n   28\\. Uncircumcised men or men with history of balanitis 29. History of urinary incontinence 30. History of recurrent (\\>3) episodes of vulvovaginitis per year, or severe symptoms 31. History of Fournier's gangrene 32. History of recurrent (≥3) UTIs per year or pyelonephritis 33. History of symptomatic hypotension or conditions predisposing to volume depletion 34. Known peripheral vascular disease, neuropathy, history of foot ulcers or lower limb amputations 35. Treatment with loop diuretics furosemide, torsemide, bumetanide, ethacrynic acid 36. Known or suspected allergy to trial medications, excipients, or related products 37. Contraindications to study medications, worded specifically as stated in the product's prescribing information","locations":[{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mona Mashayekhi, MD, PhD","phone":"615-208-5037","email":"mona.mashayekhi@vumc.org"}],"primaryOutcomes":["Adipose tissue macrophages","Flow mediated dilation","Monocyte chemoattractant protein-1"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["empagliflozin"],"locationSlugs":["nashville-tennessee"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Empagliflozin 25 MG for Obesity","inPlainEnglish":"Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue. There are no current targeted therapies to prevent or reverse the chronic inflammation of obesity, and a better understanding of these inflammatory pathways in humans is key to future therapeutic interventions.","whoItsFor":["Ages 18 Years to any","1\\. Age 18+ years old 2. Metabolic syndrome as defined by 3 or more of 5 criteria:","Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmg Hg or treatment with anti-hypertensive medications for minimum of 1 month","Triglycerides ≥ 150 mg/dL or treatment with a triglyceride-targeted medication (fenofibrate, gemfibrozil, niacin, high dose omega-3 fatty acids)","High-density lipoprotein (HDL) \\< 40 mg/dL in males or \\< 50 mg/dL in females","Fasting blood glucose ≥ 100mg/dL or treatment with glucose-lowering medications"],"whoShouldSkip":["6\\. Type 1 diabetes. 7. Poorly controlled type 2 diabetes as defined by HbA1c ≥ 9%. 8. Use of anti-diabetic medications other than stable dose of metformin or a sulfonylurea in the last 1 month","9\\. Treatment with a glucagon-like peptide-1 receptor agonist or co-agonist in the last 3 months","Criteria Related to Known Adverse Effects of Drug:"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 25 MG, or Placebo. The registry lists allocation as randomized. Obesity is associated with increased cardiometabolic disease risk due, in part, to heightened chronic inflammation arising from adipose tissue.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 74 people at Nashville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.605Z"},{"nctId":"NCT05976685","title":"Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy","officialTitle":"Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic StrokE Despite Anticoagulation Therapy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Insel Gruppe AG, University Hospital Bern","sponsorClass":"OTHER","summary":"Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF. Despite DOAC therapy, there is a significant residual stroke risk of 1-2%/year. Recent data from the Swiss Stroke Registry found 38% of patients with AF and ischemic stroke were on prior anticoagulant therapy (approximately 400 patients per year in Switzerland). The investigators found in a prior observational study, that patients with AF who have ischemic stroke despite anticoagulation are at increased risk of having another ischemic stroke (HR 1.6; 95% confidence interval, CI 1.1-2.1). Combining observational data from 11 international stroke centres, the investigators found that the majority of ischemic strokes despite anticoagulation in patients with AF is \"breakthrough\" cardioembolism (76% of patients) and only a minority of 24% is related to other causes unrelated to AF. Optimal secondary prevention strategy is unknown. The investigators have conducted two independent observational studies including together \\>4000 patients but did not identify any strategy (e.g. switch to different DOAC, additional antiplatelet therapy) that seems superior. A recent randomized controlled trial on surgical occlusion of the left atrial appendage (LAAO) found that LAAO may provide additional protection from ischaemic stroke in addition to oral anticoagulation. Triggered by this finding, the investigators performed a matched retrospective observational study and found that patients with AF and stroke despite anticoagulation who received a combined mechanical-pharmacological therapy (DOAC therapy + LAAO) had lower rates of adverse outcomes compared to those with DOAC therapy alone. Therefore, the investigators hypothesize that in patients with AF and ischemic stroke despite anticoagulant therapy, LAAO in addition to anticoagulation with a DOAC is superior to DOAC therapy alone. The investigators propose an international, multi-center randomized controlled two-arm trial to assess the effect of LAAO in patients with AF suffering from strokes despite anticoagulation therapy and without competing stroke etiology. The investigators will use the PROBE design with blinded endpoint assessment. The investigators will enrol patients with non-valvular AF and a recent ischemic stroke despite anticoagulation therapy at stroke onset. Patients will be randomized 1:1 to receive LAAO + DOAC therapy (experimental arm) or DOAC therapy alone (standard treatment arm). The primary endpoint is the first occurrence of a composite outcome of recurrent ischemic stroke, systemic embolism and cardiovascular death during follow-up. Secondary outcomes include individual components of the primary composite outcome, safety outcomes (i.e. symptomatic intracranial haemorrhage, major extracranial bleeding, serious device- or procedure-related complication), functional outcome (modified Rankin Scale) and patient-oriented outcomes. The minimum follow-up is 6 months and all patients will receive follow-ups every 6 months until end of study, the maximal follow-up will be 48 months. Based on prior observational data from the investigators' group and others (5 observational studies, \\>5000 patients), the investigators estimate the proportion of patients with the primary outcome in the standard treatment arm to be 18% in the first year and 9% in the second year (=cumulative 27% after 2 years). A relative risk reduction of 40% at 2 years would be clinically relevant. Based on these assumptions and a log-rank test, the investigators would need 98 events for a power of 80% at an alpha-level of 5%. Assuming a recruitment rate of 52, 118, 156 and 156 patients in years 1 to 4, an additional 6 months of follow-up (mean follow-up time of 2.1 years) and a uniform drop-out rate of 7.5% per year, 482 patients would need to be enrolled. How to treat patients with an ischemic stroke despite anticoagulation is a major yet unresolved clinical dilemma. This trial has the potential to answer the question whether LAAO plus DOAC therapy is superior to current standard of care for patients with AF who have ischemic stroke despite anticoagulation.","conditions":["Ischemic Stroke","Atrial Fibrillation"],"keywords":["Stroke","Direct oral anticoagulation","Left atrial appendage occlusion"],"interventions":[{"type":"PROCEDURE","name":"Left atrial appendage Occlusion"},{"type":"DRUG","name":"DOAC"}],"enrollment":482,"startDate":"2024-05-01","completionDate":"2028-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Written informed consent\n* Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization.\n* Recent (≤3 months) symptomatic ischemic stroke.\n* Active and ongoing anticoagulation therapy at stroke onset assessed based on medical history (i.e. any therapeutic oral anticoagulation therapy \\[Vitamin K antagonist/DOAC according to prescription recommendations for AF; inadequate low-dose DOAC therapy allowed for inclusion\\] not stopped/paused for \\>48 hours due to any reason, i.e. medical intervention or non-adherence).\n* Active or planned long-term therapy with DOAC\n\nExclusion Criteria:\n\n* Contraindications to DOAC therapy\n* Life expectancy \\<1 year according to the opinion of the investigator\n* Stroke due to: Ipsilateral intra/extracranial high-grade stenosis, Isolated lacunar stroke, Other well-defined stroke aetiologies (i.e., endocarditis, vasculitis, Reversible Cerebral Vasoconstriction Syndrome \\[RCVS\\], Posterior Reversible Encephalopathy Syndrome \\[PRES\\], cerebral sinus venous thrombosis)\n* Previous persistent foramen ovale or atrial septum defect closure.\n* Rheumatic heart disease\n* Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation).\n* Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer).\n* Cardiac or non-cardiac surgical procedure within 30 days of randomization\n* Enrolled in another investigation of a cardiovascular device or investigating secondary prevention therapy.\n* Severely reduced Left Ventricular Ejection Fraction (LVEF) \\<30%.\n* Severe renal impairment as described in the summary of medicinal product characteristics for the chosen DOAC (e.g. rivaroxaban, apixaban and edoxaban creatinine clearance \\<15 ml/min; dabigatran creatinine clearance \\<30 ml/min).\n* Hypertrophic cardiomyopathy\n* Intracardiac tumor\n* Ventricular thrombus\n* Acute cardiac decompensation\n* LAA is obliterated or surgically ligated\n* Persistent proximal LAA thrombus despite 4 weeks of anticoagulation (if a proximal thrombus in the LAA is found, anticoagulation with vitamin K antagonist (INR 2.5-3.5) may be started, and if the thrombus disappears, the patient may be eligible for LAAO)\n* Pregnancy or breastfeeding (pregnancy test in urine or blood to be performed at screening for women of childbearing potential)","locations":[{"facility":"AZ Sint Jan Brugge","city":"Bruges","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brussels University Hospital","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLouvain - Cliniques universitaires Saint-Luc","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"HUmani CHU Charleroi-Chimay","city":"Charleroi","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis (UZ) Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Liège Sart-Tilman","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UKSH, Campus Lübeck","city":"Lübeck","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité-Universitätsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Bonn","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Göttingen","city":"Göttingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Klinik Altona","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Heidelberg","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Leipzig","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Mannheim","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Christchurch Hospital","city":"Christchurch","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. General Universario Dr. Balmis de Alicante","city":"Alicante","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Barcelona Santa Creu y Sant Pau","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall d'Hebron University Hospital","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Clínic of Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos (HCSC)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ente Ospedaliero Cantonale","city":"Lugano","state":"Canton Ticino","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire Vaudois","city":"Lausanne","state":"Vaude","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inselspital, University Hospital Bern","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux universitaires de Genève","city":"Geneva","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Luzerner Kantonsspital","city":"Lucerne","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital St. Gallen","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stadtspital Zürich Triemli","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charing Cross Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Thomas' Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Sessex NHS Trust","city":"Worthing","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lorenz Räber, Prof., MD, PhD","phone":"+41316320929","email":"Lorenz.Raeber@insel.ch"},{"name":"David Seiffge, Prof., MD","phone":"+41316640509","email":"david.seiffge@insel.ch"}],"primaryOutcomes":["Composite of recurrent ischemic stroke, systemic embolism, or cardiovascular death (whatever comes first)."],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["bruges-belgium","brussels-belgium","charleroi-belgium","leuven-belgium","li-ge-belgium","l-beck-germany","berlin-germany","bonn-germany","g-ttingen-germany","hamburg-germany","heidelberg-germany","leipzig-germany","mannheim-germany","t-bingen-germany","christchurch-new-zealand","alicante-spain","barcelona-spain","madrid-spain","lugano-switzerland","lausanne-switzerland","basel-switzerland","bern-switzerland","geneva-switzerland","lucerne-switzerland","sankt-gallen-switzerland","zurich-switzerland","cambridge-united-kingdom","london-united-kingdom","worthing-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing DOAC for Ischemic Stroke","inPlainEnglish":"Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication. Direct oral anticoagulants (DOAC) reduce the risk of cardioembolism in patients with AF.","whoItsFor":["Ages 18 Years to any","Permanent, persistent, or paroxysmal spontaneous AF previously known or diagnosed during the index hospitalization","Recent (≤3 months) symptomatic ischemic stroke","Active or planned long-term therapy with DOAC"],"whoShouldSkip":["Contraindications to DOAC therapy","Life expectancy \\<1 year according to the opinion of the investigator","Previous persistent foramen ovale or atrial septum defect closure","Rheumatic heart disease","Severe heart valve disease that requires treatment (severe aortic stenosis or regurgitation, severe mitral stenosis or regurgitation)","Contraindications for TEE (relevant esophageal varices, esophageal stricture, history of esophageal cancer)","Cardiac or non-cardiac surgical procedure within 30 days of randomization"],"whatHappens":"If you join, the listed intervention(s) are Left atrial appendage Occlusion, or DOAC. The registry lists allocation as randomized. Atrial fibrillation (AF) is one of the most common cardiac arrhythmias and cardioembolic stroke due to AF is its major complication.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 482 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.225Z"},{"nctId":"NCT05977023","title":"NMDA Receptor Modulation for the Treatment of Bipolar I Disorder","officialTitle":"NMDA Receptor Modulation for the Treatment of Cognitive Impairment and Perceived Stress in Bipolar I Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"China Medical University Hospital","sponsorClass":"OTHER","summary":"At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress. This study aims to examine the efficacy and safety of an NMDA enhancer (NMDAE) in the treatment of cognitive impairment and perceived stress in the patients with bipolar depression.","conditions":["Bipolar I Disorder"],"keywords":["Bipolar I disorder","Bipolar depression","NMDA"],"interventions":[{"type":"DRUG","name":"NMDAE"},{"type":"DRUG","name":"Placebo Cap"}],"enrollment":90,"startDate":"2023-10-04","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Are 18 to 65 years of age;\n* Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;\n* Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;\n* Agree to participate in the study and provide informed consent\n\nExclusion Criteria:\n\n* Current substance abuse or history of substance dependence in the past 6 months\n* History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study\n* Schizophrenia or other psychotic disorder\n* Moderate-severe suicidal risks\n* Severe cognitive impairment\n* Clinically significant laboratory screening tests (including blood routine, biochemical tests)\n* Pregnancy or lactation;\n* Inability to follow protocol","locations":[{"facility":"Department of Psychiatry, China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hsien-Yuan Lane Lane, M.D., Ph.D","phone":"886 4 22052121","email":"hylane@gmail.com"}],"primaryOutcomes":["Change in Visual Continuous Performance Test","Change in Wisconsin Card Sorting Test","Change in Logical Memory Test of the Wechsler Memory Scale","Digit Span","Spatial Span","Category Fluency","Trail Marking A","WAIS-III Digit Symbol-Coding","Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) V2.0","Change in Perceived Stress Scale in Perceived Stress Scale"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["taichung-taiwan"],"enrichment":{"headline":"Phase 2: testing NMDAE for Bipolar I Disorder","inPlainEnglish":"At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress. NMDA receptor (NMDAR) dysfunction is associated with BD-I, particularly its cognitive impairment and perceived stress.","whoItsFor":["Ages 18 Years to 65 Years","Are 18 to 65 years of age;","Satisfy a DSM-5-TR (American Psychiatric Association) diagnosis of BD-I, current episode depressed, after treatment of stable (i.e., at least 4 weeks) and adequate treatment of antipsychotic (quetiapine or lurasidone) and/or mood stabilizer;","Have a 17-item Hamilton Depression Rating Scale (HAMD) score ≥18 and a Young Mania Rating Scale (YMRS) score ≤7 at baseline;"],"whoShouldSkip":["Current substance abuse or history of substance dependence in the past 6 months","History of epilepsy, head trauma, stroke or other serious medical or neurological illness which may interfere with the study","Schizophrenia or other psychotic disorder","Moderate-severe suicidal risks","Severe cognitive impairment","Clinically significant laboratory screening tests (including blood routine, biochemical tests)","Pregnancy or lactation;"],"whatHappens":"If you join, the listed intervention(s) are NMDAE, or Placebo Cap. The registry lists allocation as randomized. At present, the treatment of Bipolar I disorder (BD-I), especially its depressive episode (bipolar depression), is still limited, because there is no effective treatment for the associated cognitive impairment and perceived stress.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at Taichung. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.735Z"},{"nctId":"NCT05978414","title":"Functional Links Between the Temporomandibular Joint and the Pelvis in Gynecology","officialTitle":"Functional Relationships Between the Temporomandibular Joint and the Pelvis in Women With Gynecological Diseases of Genital Prolapse and Endometriosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Poznan University of Physical Education","sponsorClass":"OTHER","summary":"1 Recruitment. 2. Collection of written consents for the study. 3. Random assignment to groups with and without intervention. 4. Completion of questionnaires by study participants, postural pattern assessment, temporomandibular joint assessment, and platform assessment.\n\n5\\. Performance of visceral therapy in the group with intervention, in the group without intervention placebo. Duration 5 weeks, treatment 1x per week at the same time of day and given day e.g. Mondays only.\n\n6\\. Reassessment as in step 4. 7. Data collection, statistical analyses. 8. Interpretation of results for female participants. 9. Preparation of results for scientific publications.","conditions":["Prolapse; Female","Endometriosis-related Pain"],"keywords":["quaity of life","women","prolapse; female","endometriosis-related pain","visceral therapy","temporomandibular joint"],"interventions":[{"type":"OTHER","name":"Visceral therapy"},{"type":"OTHER","name":"Placebo"}],"enrollment":200,"startDate":"2023-11-14","completionDate":"2026-09-30","sex":"FEMALE","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written consent to participate in the study.\n2. Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis.\n\nExclusion Criteria:\n\n1. No written consent to participate in the study.\n2. Cancer.\n3. Injury to the temporomandibular joint and pelvis.\n4. Fibromyalgia.\n5. Rheumatic diseases.\n6. At each stage of the experiment if the patient decides that she does not want to participate she is excluded.","locations":[{"facility":"Poznan University of Physical Education","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Małgorzata E Wójcik, Dr","phone":"+4895 727 91 00","email":"m.wojcik@awf-gorzow.edu.pl"},{"name":"Anna M Paczkowska, Dr","phone":"+4861 285 40 31","email":""}],"primaryOutcomes":["NRS","platforms","postural pattern by Halla-Wernhama-Littlejohna","pelvic type assessment","CromWell (measurement of oral dilation)","standarised questonarie by Kulesa-Morawiecka et al.","According to the Polish version of the questionnaire, the highest point value, i.e. 171, indicates the lowest rank in the quality of life assessment, while the lowest point value indicates the highest level of quality of life.","Female Sexual Function Index. Score: a value of 26 points or less indicates the presence of significantly clinical sexual dysfunction.","visceral techniques and placebo","Masseter Muscles Tension"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: Visceral therapy for Prolapse; Female","inPlainEnglish":"Collection of written consents for the study. Random assignment to groups with and without intervention.","whoItsFor":["Ages 18 Years to 60 Years","Women only","Written consent to participate in the study","Female patients after surgical treatment with prolapse of reproductive organs and diagnosed endometriosis"],"whoShouldSkip":["No written consent to participate in the study","Injury to the temporomandibular joint and pelvis","Rheumatic diseases","At each stage of the experiment if the patient decides that she does not want to participate she is excluded"],"whatHappens":"If you join, the listed intervention(s) are Visceral therapy, or Placebo. The registry lists allocation as randomized. Collection of written consents for the study.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Poznan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.113Z"},{"nctId":"NCT05979363","title":"A Study of Bortezomib, Lenalidomide and Dexamethasone (VRd)-Based Regimen Followed by BCMA CAR-T Therapy in Transplant-Ineligible Patients With Primary Plasma Cell Leukemia","officialTitle":"Safety and Efficiency of VRd-based Regimen Combining BCMA CAR-T for Transplant-ineligible Patients With Primary Plasma Cell Leukemia: a Prospective, Single-arm, Single-center, Phase II Study.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","sponsorClass":"OTHER","summary":"This is a single-arm, open-label study to evaluate the efficacy and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia","conditions":["Plasma Cell Leukemia"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"anti-BCMA CAR-T"},{"type":"DRUG","name":"VRD-based regimen"}],"enrollment":20,"startDate":"2023-08-14","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 75 years.\n2. Participants with documented primary plasma cell leukemia according to IMWG diagnostic criteria (circulating plasma cells ≥5%, determined by morphology on peripheral blood smear; or absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10\\^9/L).\n3. Measurable disease, at screening as defined by any of the following: Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.\n4. Not considered for high-dose chemotherapy with Autologous Stem Cell Transplant (ASCT) due to: Ineligible due to advanced age (≥65); or Ineligible evaluated by researchers; or Eastern Cooperative Oncology Group Performance Status grade of 3 or 4; or Repeated hematopoietic stem cell mobilization failure； or Deferral of high-dose chemotherapy with ASCT as initial treatment.\n5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.\n6. All screening blood biochemistry: tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria: a.TBIL\\<2 x upper limit of normal (ULN) (\\<3 x ULN in patients with Gilbert's syndrome); b.AST and ALT \\<3 x ULN.; c. Creatinine clearance ≥ 30mL/min (calculated using Cockroft-Gault formula).\n7. Routine blood tests (performed within 7 days, no RBC transfusion, no G-CSF/GM-CSF/platelet agonists, no drug correction within 14 days before screening, no PLT transfusion within 7 days) : WBC ≥ 1.5 x 109/L, ANC ≥ 1.0 x 109/L, Hb ≥ 70 g/L PLT ≥ 75 x 109/L (if BMPC \\< 50%) or PLT ≥ 50 x 109/L (if BMPC ≥ 50%).\n8. Patients must be able to take prophylactic anticoagulant therapy as recommended by the study.\n9. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter.\n\nExclusion Criteria:\n\n1. Documented active amyloidosis.\n2. Documented with central nervous system (CNS) invasion.\n3. Prior exposure to any BCMA-targeted therapy or CAR-T therapy.\n4. Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy.\n5. Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide, and BCMA-CART cellular products.\n6. Seropositive for human immunodeficiency virus (HIV)\n7. Hepatitis B infection\n8. Hepatitis C infection\n9. Life expectancy of \\<6 months\n10. Women who are pregnant or breastfeeding\n11. Any active gastrointestinal dysfunction that affects the patient's ability to swallow tablets, or any active gastrointestinal dysfunction that may affect the absorption of the studied treatment medication\n12. Subjects had major surgery within 2 weeks before randomization (for example, general anesthesia), or is not fully recovered from the surgery, or surgery is arranged during study period.\n13. Received live attenuated vaccine within 4 weeks prior to study treatment.\n14. According to the researcher's judgment, any condition including but not limited to serious mental illness, medical illness, or other symptoms/conditions that may affect study treatment, compliance, or the capability of providing informed consent.\n15. Necessary medication or supportive therapy is contraindicated with study treatment.\n16. Any diseases or complications that may interfere with the study.\n17. Patients are not willing to or cannot comply with study scheme.","locations":[{"facility":"Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gang An, PhD&MD","phone":"86-022-23909171","email":"angang@ihcams.ac.cn"}],"primaryOutcomes":["Safety and Tolerability","MRD-negative rate"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":["car-t"],"locationSlugs":["tianjin-china"],"enrichment":{"headline":"Phase 2: testing anti-BCMA CAR-T for Plasma Cell Leukemia","inPlainEnglish":"This is a single-arm, open-label study to measure the how well it works and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia","whoItsFor":["Ages 18 Years to 75 Years","Age ≥ 18 years and ≤ 75 years","Participants with documented primary plasma cell leukemia according to IMWG diagnostic criteria (circulating plasma cells ≥5%, determined by morphology on peripheral blood smear; or absolute value of peripheral blood tumorigenic plasma cells exceeds 2×10\\^9/L)","Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination","Patients must be able to take prophylactic anticoagulant therapy as recommended by the study","The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter"],"whoShouldSkip":["Documented active amyloidosis","Documented with central nervous system (CNS) invasion","Prior exposure to any BCMA-targeted therapy or CAR-T therapy","Patients with peripheral neuropathy greater than grade 2 or peripheral neuropathy greater than grade 2 with pain at baseline, regardless of whether they were currently receiving medical therapy","Known intolerance, hypersensitivity, or contraindication to glucocorticoids, bortezomib, lenalidomide, and BCMA-CART cellular products","Seropositive for human immunodeficiency virus (HIV)","Hepatitis B infection"],"whatHappens":"If you join, the listed intervention(s) are anti-BCMA CAR-T, or VRD-based regimen. The registry lists allocation as na. This is a single-arm, open-label study to measure the how well it works and safety of VRD-based regimen combined with BCMA CAR-T in transplant-ineligible patients with primary plasma cell leukemia","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Tianjin. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.500Z"},{"nctId":"NCT05979389","title":"Bicalutamide Therapy in Young Women With NAFLD and PCOS","officialTitle":"Pilot Trial of Bicalutamide Versus Placebo in Reproductive-Aged Women With Nonalcoholic Fatty Liver Disease (NAFLD) and Polycystic Ovary Syndrome (PCOS)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. This study will study the contribution of androgens to liver injury and progression in PCOS and mechanistic role of dysregulated lipid metabolism and visceral adiposity in this process. Such findings will provide the rationale for future efficacy studies evaluating selective androgen receptor (AR) antagonism for NASH in PCOS, or alternatively, the need to directly target visceral adiposity or lipid-specific pathways as part of a precision medicine approach to halt fibrosis progression in the nearly 5 million young women with PCOS and NAFLD in the U.S., who remain at increased risk for early onset and progressive liver disease.","conditions":["NAFLD","PCOS"],"keywords":[],"interventions":[{"type":"DRUG","name":"Bicalutamide 50 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":50,"startDate":"2024-02-14","completionDate":"2028-08","sex":"FEMALE","minAge":"18 Years","maxAge":"42 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged 18-42 years with hyperandrogenic PCOS\n* NASH identified on liver biopsy or probable NASH on transient elastography- controlled attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel/m and TE score \\> 7.0 kPA or alanine aminotransferase ≥40 U/L).\n\nExclusion Criteria:\n\n* Uncontrolled diabetes\n* Alcohol consumption \\>2 drinks per day for at least 3 consecutive months over the previous 5 years\n* Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause\n* Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH\n* HIV infection\n* Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or during study\n* Recent, current, or planned upcoming pregnancy or current perimenopausal status\n* Renal impairment (glomerular filtration rate \\<45 ml/min/1.73m or potassium levels \\> 5.0 mmol/L)\n* Androgen receptor antagonist use (i.e. spironolactone or flutamide) for more than 3 months within one year prior to baseline","locations":[{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lily Carbullido","phone":"(415)-502-3725","email":"myliverhealth@ucsf.edu"}],"primaryOutcomes":["Change in liver stiffness on Magnetic Resonance Elastography (MRE)"],"hasResults":false,"conditionSlugs":["fatty-liver","pcos"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Phase 1: testing Bicalutamide 50 mg for NAFLD","inPlainEnglish":"Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S.","whoItsFor":["Ages 18 Years to 42 Years","Women only","Women aged 18-42 years with hyperandrogenic PCOS","NASH identified on liver biopsy or probable NASH on transient elastography- controlled attenuation parameter (TE-CAP) with cutoffs defined as CAP score ≥270 decibel/m and TE score \\> 7.0 kPA or alanine aminotransferase ≥40 U/L)"],"whoShouldSkip":["Uncontrolled diabetes","Alcohol consumption \\>2 drinks per day for at least 3 consecutive months over the previous 5 years","Other chronic liver disease (i.e. hepatitis B virus, hepatitis C virus, autoimmune hepatitis) or cirrhosis from any cause","Recent or planned upcoming weight reduction surgery within five years of diagnosis of biopsy-confirmed NASH","Drugs associated with fatty liver (i.e. amiodarone, methotrexate, systemic glucocorticoids, tamoxifen, anabolic steroids, valproic acid) for more than 4 weeks prior to baseline or during study","Recent, current, or planned upcoming pregnancy or current perimenopausal status","Renal impairment (glomerular filtration rate \\<45 ml/min/1.73m or potassium levels \\> 5.0 mmol/L)"],"whatHappens":"If you join, the listed intervention(s) are Bicalutamide 50 mg, or Placebo. The registry lists allocation as randomized. Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at San Francisco. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.797Z"},{"nctId":"NCT05981183","title":"Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population","officialTitle":"A Single Center Pilot Study on the Use of a Transcutaneous Auricular Vagus Nerve Stimulation Device in CKD Population","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"The purpose of this pilot interventional study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD. The primary aims are to investigate the feasibility of the protocol and generate preliminary signals of efficacy and tolerability for two different doses of vagal nerve stimulation. The pilot estimates will be used to design a larger scale study that may lead to potentially targeted interventions to reduce cardiovascular (CV) mortality in the CKD population.","conditions":["Chronic Kidney Disease"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Transcutaneous electrical nerve stimulation unit (TENS)"}],"enrollment":20,"startDate":"2023-08-09","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n• Individual 18-80 years of age with CKD stage 3-5 (eGFR \\<60 mL/min/1.73m2) on most recent outpatient labs.\n\nExclusion Criteria:\n\n* Pacemaker dependent\n* Prisoners\n* Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant.\n* Not capable of informed consent\n* Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)\n* ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)\n* Recent myocardial infarction (4 weeks or less)\n* Maintenance dialysis\n* Epilepsy\n* Patients on labetalol (labetalol will interfere with catecholamine measurements)\n* Patients with diabetes\n* At least 50% of cohort must not be on beta blockers. This will help to distinguish the confounding effects of beta blockers.","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David Charytan, MD","phone":"(646) 501-9086","email":"David.charytan@nyulangone.org"},{"name":"Qandeel Soomro, MD","phone":"(212) 263-7300","email":"Qandeel.soomro@nyulangone.org"}],"primaryOutcomes":["Heart Rate Variability (HRV) at Baseline","HRV at Post-Intervention"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Transcutaneous electrical nerve stimulation unit (TENS) for Chronic Kidney Disease","inPlainEnglish":"The purpose of this pilot treatment study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD). This data will enhance understanding of the short-term safety, tolerability and effects of this novel therapeutic approach in the setting of CKD.","whoItsFor":["Ages 18 Years to 80 Years","Individual 18-80 years of age with CKD stage 3-5 (eGFR \\<60 mL/min/1.73m2) on most recent outpatient labs"],"whoShouldSkip":["Pacemaker dependent","Pregnant women. A pregnancy test will be offered if a subject is concerned about being pregnant","Know autonomic function disorder (e.g. Parkinson's disease with autonomic dysfunction)","ICD or PPM precluding assessment of heart rate variability (e.g. chronic atrial fibrillation)","Recent myocardial infarction (4 weeks or less)","Maintenance dialysis","Patients on labetalol (labetalol will interfere with catecholamine measurements)"],"whatHappens":"If you join, the listed intervention(s) are Transcutaneous electrical nerve stimulation unit (TENS). The registry lists allocation as randomized. The purpose of this pilot treatment study is to collect preliminary data on the application of a transcutaneous auricular vagal nerve stimulation (taVNS) device in patients with chronic kidney disease (CKD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at New York. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.499Z"},{"nctId":"NCT05986292","title":"A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain","officialTitle":"A Master Protocol for Randomized, Placebo-Controlled, Phase 2 Clinical Trials of Multiple Interventions for the Treatment of Chronic Pain","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.","conditions":["Osteoarthritis, Knee","Diabetic Neuropathic Pain","Chronic Low-back Pain"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY3016859 ISA"},{"type":"DRUG","name":"LY3556050 ISA"},{"type":"DRUG","name":"LY3526318 ISA"},{"type":"DRUG","name":"LY3857210 ISA"},{"type":"DRUG","name":"Placebo Oral"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"LY4065967 ISA"}],"enrollment":10000,"startDate":"2020-01-30","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* have a visual analog scale (VAS) pain value ≥40 and \\<95 at screening and prerandomization screening.\n* have a history of daily pain for at least 12 weeks based on participant report or medical history\n* have a value of ≤30 on the pain catastrophizing scale\n* are willing to maintain a consistent regimen of any ongoing nonpharmacologic pain-relieving therapies (for example, physical therapy) and/or nutritional supplements and will not start any new nonpharmacologic pain-relieving therapies and/or nutritional supplements during study participation\n* are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study\n\nExclusion Criteria:\n\n* have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia\n* have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)\n* have surgery planned during the study for any reason, related or not to the disease state under evaluation.\n* have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation.\n* have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision.\n* have fibromyalgia\n* have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study.\n* have a positive human immunodeficiency virus (HIV) test result at screening\n* have a history of alcohol, illicit drug, analgesic or narcotic use disorder within 2 years prior to screening.","locations":[{"facility":"Central Research Associates","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Simon Williamson Clinic","city":"Birmingham","state":"Alabama","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Synexus Clinical Research - Glendale","city":"Glendale","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Research Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance for Multispecialty Research, LLC","city":"Tempe","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Irvine Clinical Research","city":"Irvine","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Desert Oasis Healthcare Medical Group","city":"Palm Springs","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CMR of Greater New Haven, LLC","city":"Hamden","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VIN-Julie Schwartzbard","city":"Aventura","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Bradenton Research Center, Inc.","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of South Florida","city":"Coral Gables","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - DeLand Clinical Research Unit","city":"DeLand","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 MEDICAL Research THE VILLAGES","city":"Lady Lake","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research ORLANDO","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Merritt Island Medical Research, LLC","city":"Merritt Island","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research - Miami, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Don Suffer Clinical Research Building","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"New Horizon Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research - St. Petersburg","city":"Pinellas Park","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Martin E. Hale M.D., P.A.","city":"Plantation","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Precision Clinical Research","city":"Sunrise","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Lady Lake","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"The Villages","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Conquest Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Clinical Research","city":"Idaho Falls","state":"Idaho","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research","city":"Chicago","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Clinical Research Center - Central Office","city":"Topeka","state":"Kansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"DelRicht Research","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Clinical Trials","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ActivMed Practices and Research","city":"Methuen","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lucida Clinical Trials","city":"New Bedford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedVadis Research Corporation","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Research Group, Inc.","city":"Bay City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinvest Research LLC","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"Omaha","state":"Nebraska","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rochester Clinical Research, LLC","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PharmQuest","city":"Greensboro","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lillestol Research","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus - 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Fort Worth","city":"Fort Worth","state":"Texas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"San Antonio","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"SYNEXUS","city":"Murray","state":"Utah","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rainier Clinical Research Center","city":"Renton","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ponce Medical School Foundation Inc.","city":"Ponce","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Latin Clinical Trial Center","city":"San Juan","state":"","country":"Puerto Rico","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants Who Were Allocated to Each ISA"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","glendale-arizona","phoenix-arizona","tempe-arizona","irvine-california","palm-springs-california","riverside-california","san-diego-california","hamden-connecticut","aventura-florida","bradenton-florida","coral-gables-florida","deland-florida","lady-lake-florida","maitland-florida","merritt-island-florida","miami-florida","new-port-richey-florida","ocala-florida","orlando-florida","pinellas-park-florida","plantation-florida","sunrise-florida","the-villages-florida","winter-park-florida","woodstock-georgia","idaho-falls-idaho","chicago-illinois","topeka-kansas","new-orleans-louisiana","boston-massachusetts","methuen-massachusetts","new-bedford-massachusetts","waltham-massachusetts","bay-city-michigan","city-of-saint-peters-missouri","springfield-missouri","omaha-nebraska","rochester-new-york","greensboro-north-carolina","fargo-north-dakota","cincinnati-ohio","columbus-ohio","dayton-ohio","tulsa-oklahoma","duncansville-pennsylvania","wyomissing-pennsylvania","north-charleston-south-carolina","austin-texas","dallas-texas","fort-worth-texas","san-antonio-texas","murray-utah","bellevue-washington","renton-washington","ponce-puerto-rico","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 2: testing LY3016859 ISA for Osteoarthritis, Knee","inPlainEnglish":"The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.","whoItsFor":["Ages 18 Years to any","have a visual analog scale (VAS) pain value ≥40 and \\<95 at screening and prerandomization screening","have a history of daily pain for at least 12 weeks based on participant report or medical history","have a value of ≤30 on the pain catastrophizing scale","are willing to discontinue all medications taken for chronic pain conditions, except rescue medication for the duration of the study"],"whoShouldSkip":["have second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia","have had a procedure within the past 6 months intended to produce permanent sensory loss in the target area of interest (for example, ablation techniques)","have surgery planned during the study for any reason, related or not to the disease state under evaluation","have, in the judgment of the investigator, an acute, serious, or unstable medical condition or a history or presence of any other medical illness that would preclude study participation","have had cancer within 2 years of baseline, except for cutaneous basal cell or squamous cell carcinoma resolved by excision","have any clinically important abnormality at screening, as determined by investigator, in physical or neurological examination, vital signs, electrocardiogram (ECG), or clinical laboratory test results that could be detrimental to the participant or could compromise the study","have a positive human immunodeficiency virus (HIV) test result at screening"],"whatHappens":"If you join, the listed intervention(s) are LY3016859 ISA, LY3556050 ISA, or LY3526318 ISA. The registry lists allocation as randomized. The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 10,000 people at 64 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.510Z"},{"nctId":"NCT05987241","title":"Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study","officialTitle":"MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of ADjuvant ThErapy in URothelial CaNcer","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids to determine which patients are at higher risk for disease progression or relapse. In this study, a blood test is used to measure ctDNA and see if there is still cancer somewhere in the body after surgery and if giving a treatment will help eliminate the cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and relatlimab, can help the body's immune system to attack the cancer, and can interfere with the ability of tumor cells to grow and spread. This trial may help doctors determine if ctDNA measurement in blood can better identify patients that need additional treatment, if treatment with nivolumab prolongs patients' life and whether the additional immunotherapy treatment with relatlimab extends time without disease progression or prolongs life of urothelial cancer patients who have undergone surgical removal of their bladder, kidney, ureter or urethra.","conditions":["Muscle Invasive Bladder Urothelial Carcinoma","Muscle Invasive Renal Pelvis Urothelial Carcinoma","Muscle Invasive Ureter Urothelial Carcinoma","Muscle Invasive Urethral Urothelial Carcinoma","Stage II Bladder Urothelial Carcinoma AJCC v6 and v7","Stage III Bladder Urothelial Carcinoma AJCC v6 and v7","Stage IV Bladder Urothelial Carcinoma AJCC v7"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"OTHER","name":"cfDNA or ctDNA Measurement"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Cystoscopy"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"BIOLOGICAL","name":"Relatlimab"}],"enrollment":992,"startDate":"2024-02-02","completionDate":"2030-09-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis\n* PRE-REGISTRATION (STEP 0): Variant histology, including neuroendocrine differentiation, sarcomatoid, micropapillary, glandular, trophoblastic, Mullerian, is allowed if urothelial cancer is predominant histology (any amount of squamous differentiation is allowed provided the tumor is not a pure squamous cell cancer)\n* PRE-REGISTRATION (STEP 0): Radical surgery (cystectomy with lymph node dissection or nephroureterectomy or ureterectomy) must be ≥ 3 weeks and ≤ 12 weeks (central Signatera pathway) or ≤ 16 weeks (commercial Signatera pathwary) prior to pre-registration. Patients who have had a partial cystectomy as definitive therapy are not eligible\n* PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible\n* PRE-REGISTRATION (STEP 0): No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., \"positive margins\") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins\n* PRE-REGISTRATION (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)\n* PRE-REGISTRATION (STEP 0): Have undergone a radical cystectomy nephroureterectomy, or ureterectomy with pathological evidence of urothelial carcinoma at high risk of recurrence as described in one of the two scenarios below (i or ii). The 7th edition of American Joint Committee on Cancer (AJCC) staging will be utilized.:\n\n  * (i) Patients who have not received neoadjuvant systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy\n\n    * (i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:\n\n      * (i) Creatinine Clearance (using Cockcroft-Gault): \\< 60 mL/min\n      * (i) Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade \\>= 2 audiometric hearing loss\n      * (i) CTCAE version 5, grade \\>= 2 or above peripheral neuropathy\n      * New York Heart Association Class III heart failure\n      * (i) Eastern Cooperative Oncology Group (ECOG) performance status = 2\n    * (i) Patients who are eligible for adjuvant cisplatin may be candidates if they refuse adjuvant cisplatin-based chemotherapy, despite being informed by the investigator about the treatment options. The patient's refusal must be documented.\n\n      * (i) Patients with pT2N0 urothelial cancer on radical surgery specimen (without prior neoadjuvant systemic therapy) with ctDNA(+) Signatera results are eligible only if the result was obtained via commercial testing (central testing is not permitted for this population) (Note: this is distinct from patients with ypT2N0 who are eligible based on ii).\n  * (ii) Patients who received neoadjuvant systemic therapy: ypT2-T4N0 or Nx or ypTanyN+ on radical surgery (i.e., cystectomy. , nephroureterectomy, or ureterectomy) pathology specimen. Neoadjuvant systemic therapy may have included cisplatin-based chemotherapy, cisplatin-based chemotherapy plus PD-1/PD-L1 blockade, or enfortumab vedotin plus PD-1/PD-L1 blockade\n* PRE-REGISTRATION (STEP 0): Patients are required to meet criteria for one of two criteria:\n\n  * 1\\) Commercial Signatera pathway:\n\n    * Available commercial Signatera testing result (i.e., ctDNA+ or ctDNA-) from blood sample obtained ≥ 3 weeks and ≤ 16 weeks from time of radical surgery performed as part of standard care\n\n      * Sites are required to verify that the commercial Signatera report demonstrates a complete 16 target assay design and that the test was designed on exome. This verification is conducted at the site level during the eligibility review. OR\n  * Central Signatera pathway:\n\n    * Pre-registration samples are to be submitted after pre-registration, at ≥ 3 weeks but ≤ 12 weeks from the time of radical surgery\n\n      * Ineligible patients for the commercial pathway must use the central Signatera pathway and provide tumor tissue as part of the A032103 study\n      * For patients who have not had neoadjuvant chemotherapy, tumor tissue is preferred from the radical surgery specimen\n      * For patients who have had neoadjuvant therapy, tissue is preferred from the pre-chemotherapy specimen diagnosing muscle-invasive disease (e.g., transurethral resection of bladder tumor specimen)\n* PRE-REGISTRATION (STEP 0): Age \\>= 18 years\n* PRE-REGISTRATION (STEP 0): ECOG performance status 0-2\n* PRE-REGISTRATION (STEP 0): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects\n* PRE-REGISTRATION (STEP 0): No postoperative adjuvant systemic therapy after radical surgery\n* PRE-REGISTRATION (STEP 0): No adjuvant radiation after radical surgery\n* PRE-REGISTRATION (STEP 0): No treatment with any other type of investigational agent =\\< 4 weeks before pre-registration\n* PRE-REGISTRATION (STEP 0): No previous treatment with LAG-3 blockade therapy\n* PRE-REGISTRATION (STEP 0): Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* PRE-REGISTRATION (STEP 0): Absolute neutrophil count (ANC) \\>= 1,200/mm\\^3\n* PRE-REGISTRATION (STEP 0): Platelet count \\>= 100,000/mm\\^3\n* PRE-REGISTRATION (STEP 0): Hemoglobin \\>= 8 g/dL\n* PRE-REGISTRATION (STEP 0): Creatinine =\\< 1.5 x upper limit of normal (ULN) or calculated (calc.) creatinine clearance \\> 30 mL/min (using either Cockcroft-Gault formula or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation\n* PRE-REGISTRATION (STEP 0): Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\\< 3 x ULN\n* PRE-REGISTRATION (STEP 0): Total bilirubin =\\< 1.5 x upper limit of normal (ULN) (except in patients with Gilbert Syndrome, who can have total bilirubin \\< 3.0 mg/dL)\n* PRE-REGISTRATION (STEP 0): For women of childbearing potential only: A negative urine or serum pregnancy test done =\\< 14 days prior to pre-registration is required\n* PRE-REGISTRATION (STEP 0): Not currently requiring hemodialysis\n* PRE-REGISTRATION (STEP 0): No current or prior history of myocarditis\n* PRE-REGISTRATION (STEP 0): No history of a grade ≥ 3 immune related adverse event with prior PD-1/PD-L1 blockade in the neoadjuvant setting\n* PRE-REGISTRATION (STEP 0): No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens- Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.\n* PRE-REGISTRATION (STEP 0): Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n* PRE-REGISTRATION (STEP 0): Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.\n* PRE-REGISTRATION (STEP 0): No current pneumonitis or prior history of non-infectious pneumonitis that required steroids within the previous 5 years.\n* PRE-REGISTRATION (STEP 0): No known active hepatitis B (e.g., hepatitis B surface antigen \\[HBsAg\\] reactive) or hepatitis C (e.g., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] is detected).\n* PRE-REGISTRATION (STEP 0): For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* PRE-REGISTRATION (STEP 0): Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible.\n* PRE-REGISTRATION (STEP 0): No concurrent antineoplastic therapy including anti-hormonal treatments used for cancer therapy (e.g., leuprolide, antiandrogens)\n* PRE-REGISTRATION (STEP 0): No current immunosuppressive agents (except for corticosteroids as described below).\n* PRE-REGISTRATION (STEP 0): No condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of pre-registration (with the exception of steroid pre-medications for contrast allergies). Inhaled or topical steroids and adrenal replacement doses \\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* REGISTRATION (STEP 1): Patient must have had radical cystectomy and lymph node dissection or nephroureterectomy or ureterectomy =\\< 18 weeks prior to registration.\n* REGISTRATION (STEP 1): Must have evaluable ctDNA Signatera assay result (i.e., ctDNA+ or ctDNA-) based on either:\n\n  * Commercial Signatera result OR\n  * Central Signatera testing result (i.e. testing that was performed as part of A032103.)\n* REGISTRATION (STEP 1): All patients must have confirmed disease-free status defined as no measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or definitive non-measurable radiographic metastatic disease, within 60 days prior to registration. Patients with equivocal lymph nodes less than 15 mm in short axis, or \\< 10 mm in long axis for non-lymph node lesions, not considered by the investigator to represent malignant disease will be eligible. Attempts should be made to resolve the etiology of equivocal lesions with complementary imaging (e.g., PET scan) or biopsy.\n* REGISTRATION (STEP 1): No major surgery =\\< 3 weeks before registration.\n* REGISTRATION (STEP 1): No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette- Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines are not live vaccines and are allowed\n* REGISTRATION (STEP 1): No change since Step 0 pre-registration in clinical condition and/or laboratory tests that would impact the safety of nivolumab +/- relatlimab administration in the opinion of the treating investigator\n* REGISTRATION (STEP 1): No evidence of high grade urothelial cancer in the bladder for patients with primary urothelial cancers of the upper urinary tract\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * Patient must have converted to ctDNA(+) during serial monitoring performed centrally as part of A032103\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * No evidence of metastatic disease on the most recent scheduled imaging assessment as outlined in the study calendar (no repeat imaging is necessary specifically at the time of the conversion from ctDNA\\[-\\] to ctDNA\\[+\\]).\n* RE-REGISTRATION (STEP 2) COHORT B, ARM 4 PATIENTS INITIATING NIVOLUMAB AFTER CONVERSION OF ctDNA ASSAY FROM ctDNA(-) to ctDNA (+):\n\n  * In the opinion of the treating investigator, patient clinical condition and laboratory tests would not impact the safety of nivolumab administration in the opinion of the treating investigator","locations":[{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-Orange Grove Campus","city":"Tucson","state":"Arizona","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Banner University Medical Center - 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2 / Phase 3: testing Nivolumab for Muscle Invasive Bladder Urothelial Carcinoma","inPlainEnglish":"This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test. Many types of tumors tend to lose cells or release different types of cellular products including their DNA which is referred to as circulating tumor DNA (ctDNA) into the bloodstream before changes can be seen on scans.","whoItsFor":["Ages 18 Years to any","PRE-REGISTRATION (STEP 0): Histologically confirmed muscle-invasive urothelial carcinoma of the urethra, bladder, ureter or renal pelvis","PRE-REGISTRATION (STEP 0): Patients who have had a partial cystectomy as definitive therapy are not eligible","PRE-REGISTRATION (STEP 0): No gross cancer at the surgical margins. Microscopic invasive urothelial carcinoma at the surgical margins (i.e., \"positive margins\") are allowed. Carcinoma in situ (CIS) at margins is considered negative margins","PRE-REGISTRATION (STEP 0): No evidence of residual cancer or metastasis after radical cystectomy or nephroureterectomy or ureterectomy (imaging is not required prior to pre-registration but is required prior to registration)","(i) Patients who have not received neoadjuvant systemic therapy: pT4N0 or pTanyN+ on radical surgery pathology specimen (i.e., cystectomy, nephroureterectomy, or ureterectomy) and are not eligible for adjuvant cisplatin chemotherapy","(i) Patients ineligible for cisplatin due to at least one of the following criteria and reason for ineligibility should be documented:","(i) Creatinine Clearance (using Cockcroft-Gault): \\< 60 mL/min"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, cfDNA or ctDNA Measurement, or Computed Tomography. The registry lists allocation as randomized. This phase II/III trial examines whether patients who have undergone surgical removal of bladder, kidney, ureter or urethra, but require an additional treatment called immunotherapy to help prevent their urinary tract (urothelial) cancer from coming back, can be identified by a blood test.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 992 people at 505 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.904Z"},{"nctId":"NCT05988385","title":"The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study","officialTitle":"The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults (ESSENTIAL) Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"California Pacific Medical Center Research Institute","sponsorClass":"OTHER","summary":"The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an \"effective\" AHI4%\\< 10/hour and AHI3A\\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.","conditions":["Obstructive Sleep Apnea","Cognitive Decline"],"keywords":["Obstructive Sleep Apnea","OSA","Cognitive decline","Alzheimer Disease","AD","AD biomarkers","Positive Airway Pressure","PAP","CPAP","Oral appliance therapy","OAT","Positional therapy","Sleep-dependent memory"],"interventions":[{"type":"DEVICE","name":"Positive airway pressure"},{"type":"DEVICE","name":"Oral appliance therapy"},{"type":"DEVICE","name":"Positional therapy"}],"enrollment":200,"startDate":"2024-08-29","completionDate":"2027-08-31","sex":"ALL","minAge":"55 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Cognitively normal (TiCS ≥29)\n* Age 55-85 years\n* Moderate - severe OSA defined as AHI4 ≥20 events/hour or AHI3A\\>40/hr using a hypopnea criterion of a 4% oxygen desaturation (AHI4) or 3% oxygen desaturation and/or EEG arousal (AHI3A), or equivalent based on in-home testing - Testing must have been completed in past 12 months or confirmed by repeat test\n* Not currently on therapy for OSA and has not received treatment for OSA for at least 6months\n* Able and willing to be treated for OSA (Treatment group)\n* Fluency in English or Spanish\n\nExclusion Criteria:\n\n* Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form\n* Documented diagnosis of circadian rhythm disorder\n* Any current use of supplemental oxygen\n* Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria\n* Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo\n* Anticipated scheduled bariatric surgery within the next 3 months\n* Chronic regular (\\> 2 nights per week) of cannabis for sleep\n* Chronic regular use (\\> 2 nights per week) of sedatives/hypnotics for sleep\n* Diagnosis of uncontrolled psychiatric disease in the last six months , and/or history of schizophrenia or bipolar disorder. Controlled conditions will include major depressive disorder, panic disorder, generalized anxiety disorder, OCD, substance use disorders, and alcohol abuse/dependence. Personality disorders and neurodevelopmental disorders (e.g. autism, ADHD) are allowed if cognition is within normal limits.\n* Taking methylphenidate for ADHD. Unless on stable dose which will be reviewed by the PI to determine.\n* Taking GLP-1 agonist semaglutide (Ozempic, Wegovy, Rybelsus), or tirzepatide (Mounjaro, Zepbound), or similar for weightloss, and planning to lose an additional 20lbs or more at the time of enrollment. PI Discretion for determination of why they are taking the drug based on conversation with subject and medical chart, will be documented in form of Note-to-file in the subject's records\n* Presence of other comorbid condition that would lead to inability to complete the study protocol (including follow-up for 2 years), or that would affect cognition (e.g. clinically relevant endocrine or hematological conditions).\n* Does not have a regular sleeping environment (i.e., sleeps in a different setting \\> 2 nights per week).\n* Currently pregnant or planning to become pregnant.\n* Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, epilepsy, a loss of consciousness \\> 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with MCI or Alzheimer's disease based on neuropsychological testing will be excluded. Delirium in the last 12 months.\n* Near-miss or prior automobile accident \"due to sleepiness\" within the past 12 months.\n* Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots).\n* Any use of neuroleptics, benzodiazepines, barbiturates, opiates or anti-amyloid therapies.\n* Use of other cognitive enhancing drugs will also be excluded if initiated in the last 3 months, or not on stable dose.\n* Consumption of \\>14 alcohol drinks per week, unless alcohol consumption can be reduced if initiated in the last 3 months.","locations":[{"facility":"University of Arizona","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Takemori","phone":"415-633-6229","email":"lisa.takemori@ucsf.edu"},{"name":"Katie L Stone, PhD","phone":"415-476-6128","email":"katie.stone@ucsf.edu"}],"primaryOutcomes":["Change in overnight memory retention on the A-B verbal paired associates task","Change in overnight memory retention on the A-B verbal paired associates task","Change in overnight memory retention on the A-B verbal paired associates task","Change in Aβ42/ Aβ40 ratio","Change in Aβ42/ Aβ40 ratio","Change in Plasma P-tau181","Change in Plasma P-tau181","Change in P-tau217","Change in P-tau217","Change in Neurofibrilary light (NfL)","Change in Neurofibrilary light (NfL)","Preclinical Cognitive Composite Score","Preclinical Cognitive Composite Score","Preclinical Cognitive Composite Score"],"hasResults":false,"conditionSlugs":["alzheimer","sleep-apnea"],"drugSlugs":[],"locationSlugs":["tucson-arizona","new-york-new-york","pittsburgh-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Positive airway pressure for Obstructive Sleep Apnea","inPlainEnglish":"The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomly assigned open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomly assigned to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an \"effective\" AHI4%\\< 10/hour and AHI3A\\<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period.","whoItsFor":["Ages 55 Years to 85 Years","Cognitively normal (TiCS ≥29)","Not currently on therapy for OSA and has not received treatment for OSA for at least 6months","Able and willing to be treated for OSA (Treatment group)","Fluency in English or Spanish"],"whoShouldSkip":["Documented diagnosis of chronic insomnia, or sleep onset insomnia based on Insomnia Severity Index - an answer of severe or very severe in the screening form","Documented diagnosis of circadian rhythm disorder","Any current use of supplemental oxygen","Other sleep-related breathing disorders (central sleep apnea, etc) based on AASM criteria","Current shift work involving night shift (regular work between 12am and 6am or night shift) within the past 6 mo","Anticipated scheduled bariatric surgery within the next 3 months","Chronic regular (\\> 2 nights per week) of cannabis for sleep"],"whatHappens":"If you join, the listed intervention(s) are Positive airway pressure, Oral appliance therapy, or Positional therapy. The registry lists allocation as randomized. The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomly assigned open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.945Z"},{"nctId":"NCT05989893","title":"Mapping of Human Cognition","officialTitle":"Mapping of Human Cognition","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The University of Texas Health Science Center, Houston","sponsorClass":"OTHER","summary":"The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions \"essential\" for these processes, to compare the loci of \"crucial\" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.","conditions":["Epilepsy","Brain Tumor"],"keywords":["seizure"],"interventions":[{"type":"BEHAVIORAL","name":"Language-based tasks"}],"enrollment":75,"startDate":"2022-08-01","completionDate":"2028-07-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes (including depth electrodes) to localize the site of seizure onset and to map the locations of critical language and motor regions\n* patients with epilepsy, brain tumors or cortically based vascular malformations (cavernous malformations or arterio-venous malformations) with lesions that are/were proximate to crucial brain regions, and who are scheduled to undergo or have previously undergone intra-op mapping of motor, visual or language function, or a Wada test, or maybe part of an awake craniotomy.\n* proficiency in English\n\nExclusion Criteria:\n\n* Gross structural abnormalities (large hamartomata, tumors, large vascular malformations, very large diffuse malformations of cortical development) that may have impacted upon the location of critical brain areas.\n* Unable to participate in testing due to impaired cognition or mental retardation.\n* Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices\n* Patients with claustrophobia who cannot undergo an MRI scan without sedation","locations":[{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nitin Tandon, MD","phone":"713-500-5456","email":"Nitin.Tandon@uth.tmc.edu"},{"name":"Eliana M Klier","phone":"713-500-5442","email":"Eliana.Klier@uth.tmc.edu"}],"primaryOutcomes":["Change in reading errors as assessed by the number of words read incorrectly","Change in reaction times in milliseconds"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Language-based tasks for Epilepsy","inPlainEnglish":"This study wants to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions \"essential\" for these processes, to compare the loci of \"crucial\" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.","whoItsFor":["Ages 18 Years to 75 Years","patients with medically refractory epilepsy who are scheduled to undergo or have previously undergone placement of sub-dural electrodes (including depth electrodes) to localize the site of seizure onset and to map the locations of critical language and motor regions","proficiency in English"],"whoShouldSkip":["Gross structural abnormalities (large hamartomata, tumors, large vascular malformations, very large diffuse malformations of cortical development) that may have impacted upon the location of critical brain areas","Unable to participate in testing due to impaired cognition or mental retardation","Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted metallic devices","Patients with claustrophobia who cannot undergo an MRI scan without sedation"],"whatHappens":"If you join, the listed intervention(s) are Language-based tasks. The registry lists allocation as na. This study wants to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions \"essential\" for these processes, to compare the loci of \"crucial\" language, visual, motor and cognitive sit","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 75 people at Houston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.907Z"},{"nctId":"NCT05991128","title":"The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life","officialTitle":"The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFpEF)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"China-Japan Friendship Hospital","sponsorClass":"OTHER","summary":"This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.","conditions":["Heart Failure With Preserved Ejection Fraction","Iron Deficiencies","Acute Heart Failure"],"keywords":["Exercise capacity","Quality of life","Acute Heart Failure"],"interventions":[{"type":"DRUG","name":"Ferric derisomaltose"},{"type":"DRUG","name":"Placebo"}],"enrollment":170,"startDate":"2023-08-01","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) ≥50% before randomization.\n3. Currently hospitalized for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalization, New York Heart Association (NYHA) class II - IV.N-terminal pro brain natriuretic peptide (NT-proBNP) ≥300 or brain natriuretic peptide (BNP) ≥100 pg/mL in sinus rhythm, or NT-proBNP≥600 or BNP ≥200 pg/mL in atrial fibrillation prior to randomization\n4. Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:\n\n   1. Systolic blood pressure≥100mmHg, without symptoms of hypotension;\n   2. Stop using intravenous diuretics;\n   3. Neither intravenous inotropic drugs or vasodilators were used (including nitrates).\n5. Subject is iron deficient defined as serum ferritin \\<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \\<20%.\n6. Able and willing to provide informed consent and accomplish 6 minutes-walking test.\n\nExclusion Criteria:\n\n1. Haematological criteria: ferritin \\>400ug/L; haemoglobin \\<9.0 g/dL, or \\>13.5 g/dL (for female), 14.5g/dL (for male).\n2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15ml/min/1.73m2\n3. Body weight\\<35kg at randomization.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload or hemochromatosis (or first-degree relative of haemochromatosis)\n6. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).\n7. Non-iron deficiency anaemia.\n8. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.\n9. Active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal haemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease) and history of malignant tumor.\n10. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean heart rate\\> 100 beats / min at rest).\n11. Known positive HBsAg and/or HCV RNA; known HIV positivity; chronic liver disease (including active hepatitis), hepatic sclerosis, ALT or AST \\> 3x upper limit of normal.\n12. Within 3 months of any of the following: acute myocardial infarction (AMI) or acute coronary syndrome (ACS), transient ischemic attack (TIA) or stroke, uncontrolled hypertension.\n13. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) in the past 3 months; or planning cardiac surgery or revascularization.\n\n14.6 minutes-walking distance\\>500m at baseline. 15.Treated with long-term oral high-dose or steroid-immunosuppression therapy. 16.Investigator considers a possible alternative diagnosis to explain the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease (COPD).\n\n17.Subject is pregnant (e.g., positive human chorionic gonadotropin test) or breast feeding.\n\n18.Untreated hypothyroidism. 19.Currently enrolled in any other investigational device or drug study \\<30 days prior to screening or received other investigational agent(s).","locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Chaoyang District","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ying Zhou, Dr","phone":"+86-13699164283","email":"929352903@qq.com"},{"name":"Peizhao Li, Dr","phone":"+86-18443151740","email":"lipz7014@163.com"}],"primaryOutcomes":["Change in 6-minute walking distance"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 4: testing Ferric derisomaltose for Heart Failure With Preserved Ejection Fraction","inPlainEnglish":"This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as dummy treatment (placebo).","whoItsFor":["Ages 18 Years to any","Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) ≥50% before randomization","Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:","Systolic blood pressure≥100mmHg, without symptoms of hypotension;","Stop using intravenous diuretics;","Neither intravenous inotropic drugs or vasodilators were used (including nitrates)","Subject is iron deficient defined as serum ferritin \\<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \\<20%"],"whoShouldSkip":["Haematological criteria: ferritin \\>400ug/L; haemoglobin \\<9.0 g/dL, or \\>13.5 g/dL (for female), 14.5g/dL (for male)","Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15ml/min/1.73m2","Body weight\\<35kg at randomization","Heart failure was secondary to valvular diseases or congenital heart diseases","History of acquired iron overload or hemochromatosis (or first-degree relative of haemochromatosis)","Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment))","Non-iron deficiency anaemia"],"whatHappens":"If you join, the listed intervention(s) are Ferric derisomaltose, or Placebo. The registry lists allocation as randomized. This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 170 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.432Z"},{"nctId":"NCT05994976","title":"Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers","officialTitle":"Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers for Molecular Characterization of Inflammatory Skin Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Innovaderm Research Inc.","sponsorClass":"OTHER","summary":"The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.","conditions":["Acne","Atopic Dermatitis","Chronic Hand Eczema","Hidradenitis Suppurativa","Plaque Psoriasis","Palmoplantar Pustulosis"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Blood samples collection"},{"type":"PROCEDURE","name":"Oral samples collection"},{"type":"PROCEDURE","name":"Hair samples collection"},{"type":"PROCEDURE","name":"Skin samples collection (skin tape strip and/or skin biopsy, and/or skin scraping)"},{"type":"PROCEDURE","name":"Skin surface material samples"},{"type":"PROCEDURE","name":"Drainage fluid samples collection"},{"type":"PROCEDURE","name":"Stool samples collection"}],"enrollment":500,"startDate":"2023-10-17","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAll subjects:\n\n1. Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.\n2. Subject must be willing to comply with all study procedures and must be available for the duration of the study.\n\n   Healthy volunteers:\n3. Male or female subject aged 18 years or older, at the time of consent.\n4. Subject is in good general health, according to the investigator's judgment.\n\n   Subjects with Acne:\n5. Male or female subject aged 18 to 45 years old, inclusive, at the time of consent.\n\n   Subjects with AD:\n6. Male or female subject aged 18 years or older, at the time of consent.\n7. Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria.\n\n   Subjects with CHE:\n8. Male or female subject aged 18 years or older, at the time of consent.\n9. Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject).\n\n   Subjects with HS:\n10. Male or female subject aged 18 years or older, at the time of consent.\n11. Subject has a clinically confirmed diagnosis of active HS with a disease duration of ≥ 6 months before screening as determined by the investigator through subject interview and/or review of the medical history.\n\n    Subjects with PPP:\n12. Male or female subject aged 18 years or older at the time of consent.\n13. Subject has at least a 6-month history of PPP as defined by the presence of pustules on palms and/or soles, but without evidence of infection on palms and soles (information obtained from medical chart or subject's physician, or directly from the subject).\n\n    Subjects with psoriasis:\n14. Male or female subject aged 18 years or older, at the time of consent.\n\nExclusion Criteria:\n\nAll subjects:\n\n1. Subject is a female who is pregnant or who is planning to become pregnant during the study.\n2. Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments.","locations":[{"facility":"Innovaderm Research Inc.","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie Bedoucha, MSc","phone":"514-521-4285","email":"jbedoucha@innovaderm.com"}],"primaryOutcomes":["Untargeted biomarker approach with gene expression profile of skin samples","Exploratory biomarker and gene expression analyses."],"hasResults":false,"conditionSlugs":["psoriasis","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: Blood samples collection for Acne","inPlainEnglish":"The purpose of the study is to collect different samples for molecular characterization of inflammatory skin diseases.","whoItsFor":["Ages 18 Years to any","Healthy volunteers:","Male or female subject aged 18 years or older, at the time of consent","Subject is in good general health, according to the investigator's judgment","Subjects with Acne:","Male or female subject aged 18 to 45 years old, inclusive, at the time of consent","Subject has clinically confirmed diagnosis of active AD, according to Hanifin and Rajka criteria","Subject has at least a 6-month history of CHE before Screening (information obtained from medical chart or subject's physician, or directly from the subject)"],"whoShouldSkip":["Subject is a female who is pregnant or who is planning to become pregnant during the study","Subject has a history of skin disease or presence of skin condition that, in the opinion of the investigator, would interfere with the study assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Montreal. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.582Z"},{"nctId":"NCT05995353","title":"A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \\< 18 years old who have had intolerance or inadequate response to other therapies.\n\nRisankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 sites worldwide.\n\nParticipants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","conditions":["Crohn's Disease"],"keywords":["Crohn's Disease","Risankizumab","Skyrizi","Pediatrics"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Risankizumab"}],"enrollment":110,"startDate":"2023-12-11","completionDate":"2029-04","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pediatric individuals, 2 to \\< 18 years old\n* Must have moderately to severely active CD, as defined by the PCDAI score \\> 30 assessed at Baseline\n* Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)\n* Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies\n\nExclusion Criteria:\n\n* History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class\n* Any of the following medical disorders:\n\n  1. Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.\n  2. A diagnosis of CD prior to 2 years of age.\n  3. A diagnosis or suspected diagnosis of a primary immunodeficiency.\n  4. Currently known complications of CD such as:\n\n     * Active abscess (abdominal or perianal);\n     * Symptomatic bowel strictures;\n     * \\> 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;\n     * Fulminant colitis;\n     * Toxic megacolon;\n     * Or any other manifestation that might require surgery while enrolled in the study.\n  5. Ostomy or ileoanal pouch.\n  6. Diagnosis of short gut or short bowel syndrome.\n  7. Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of \\>3 bowel resections.","locations":[{"facility":"Phoenix Children's Hospital /ID# 255766","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Children's Hospital /ID# 255762","city":"Little Rock","state":"Arkansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UCSF Benioff Children's Hospital - Oakland /ID# 258327","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado - Aurora /ID# 255764","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Riley Hospital for Children /ID# 256454","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital - Mass General Waltham /ID# 255767","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MNGI Digestive Health, P. A. /ID# 255366","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Goryeb Childrens Hospital /ID# 256452","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai /ID# 254880","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic - Cleveland /ID# 256453","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uza /Id# 255114","city":"Edegem","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires UCL Saint-Luc /ID# 255108","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Brussel /ID# 255109","city":"Jette","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Leuven /ID# 255098","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universite Enfants Reine Fabiola /ID# 255112","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Groupe Sante CHC - Clinique du MontLegia /ID# 255620","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMHAT Sveti Georgi EAD /ID# 255386","city":"Plovdiv","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384","city":"Sofia","state":"","country":"Bulgaria","status":"COMPLETED","lat":null,"lon":null},{"facility":"UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358","city":"Varna","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Children's Hospital /ID# 255357","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edmonton Clinic Health Academy /ID# 255361","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Children's Hospital /ID# 255359","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Children's Hospital /ID# 256081","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital /ID# 255876","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Children's Hospital /ID# 255610","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Provincial Children's Hospital /ID# 255564","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengjing Hospital of China Medical University /ID# 255563","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Shanghai /ID# 255531","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vseobecna Fakultni nemocnice v Praze /ID# 256096","city":"Prague","state":"Praha 17","country":"Czechia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Fakultni nemocnice Motol a Homolka /ID# 256547","city":"Prague","state":"Praha 5","country":"Czechia","status":"COMPLETED","lat":null,"lon":null},{"facility":"CHRU Tours - Hopital Gatien de Clocheville /ID# 255052","city":"Tours","state":"Centre-Val de Loire","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu Bordeaux - Hopital Pellegrin /ID# 257060","city":"Bordeaux","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Toulouse - Hopital Paule de Viguier /ID# 255609","city":"Toulouse","state":"Occitanie","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 255443","city":"Bron","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HP - Hopital Necker /ID# 255608","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr. von Haunerschen Kinderspital /ID# 255577","city":"Munich","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Muenster /ID# 256762","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Schneider Children's Medical Center /ID# 254950","city":"Petah Tikva","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center /ID# 254951","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Giannina Gaslini /ID# 255262","city":"Genoa","state":"Genova","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu /ID# 255043","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044","city":"Messina","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Children's Health And Medical Center /ID# 272085","city":"Ōbu","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tsujinaka Hospital - Kashiwanoha /ID# 268409","city":"Kashiwa-shi","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kurume University Hospital /ID# 268418","city":"Kurume-shi","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gunma University Hospital /ID# 270560","city":"Maebashi","state":"Gunma","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Kumamoto Hospital /ID# 268586","city":"Kumamoto","state":"Kumamoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Women's and Children's Hospital /ID# 268419","city":"Izumi-Shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Children's Medical Center /ID# 268410","city":"Saitama-shi","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital /ID# 269175","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Children's Medical Center /ID# 268415","city":"Fuchu-shi","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Center For Child Health And Development /ID# 268420","city":"Setagaya City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam University Medical Center /ID# 254827","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastromed Sp. z o.o /ID# 255939","city":"Torun","state":"Kuyavian-Pomeranian Voivodeship","country":"Poland","status":"COMPLETED","lat":null,"lon":null},{"facility":"Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Puerto Rico Health Institute /ID# 255071","city":"Dorado","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Puerto Rico /ID# 266479","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital /ID# 255318","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Health System - Severance Hospital /ID# 256976","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center /ID# 255284","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyungpook National University Chilgok Hospital /ID# 255817","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614","city":"Ferrol","state":"A Coruna","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Infantil Universitario Nino Jesus /ID# 255012","city":"Madrid","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Malaga /ID# 257553","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sodersjukhuset /ID# 255239","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Astrid Lindgrens Barnsjukhus /ID# 255240","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sahlgrenska Universitetssjukhuset /ID# 255236","city":"Gothenburg","state":"Västra Götaland County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kinderspital Zurich - Eleonorenstiftung /ID# 255337","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inselspital, Universitaetsspital Bern /ID# 255321","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital /ID# 256082","city":"Changhua City, Changhua County","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital /ID# 255679","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gazi University Medical Faculty /ID# 255086","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sariyer Hamidiye Etfal Egitim Ve Araştirma Hastanesi /ID# 257143","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kocaeli University Med Faculty /ID# 256922","city":"Kocaeli","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital NHS Foundation Trust /ID# 255758","city":"Sheffield","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Women's and Children's NHS Foundation Trust /ID# 255759","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission","Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)","Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab","Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab","Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab"],"hasResults":false,"conditionSlugs":["psoriasis","crohns-disease"],"drugSlugs":["risankizumab"],"locationSlugs":["phoenix-arizona","little-rock-arkansas","oakland-california","aurora-colorado","orlando-florida","indianapolis-indiana","waltham-massachusetts","minneapolis-minnesota","morristown-new-jersey","new-york-new-york","cleveland-ohio","edegem-belgium","brussels-belgium","jette-belgium","leuven-belgium","li-ge-belgium","plovdiv-bulgaria","sofia-bulgaria","varna-bulgaria","calgary-canada","edmonton-canada","vancouver-canada","london-canada","beijing-china","guangzhou-china","zhengzhou-china","changsha-china","nanchang-china","shenyang-china","shanghai-china","prague-czechia","tours-france","bordeaux-france","toulouse-france","bron-france","paris-france","munich-germany","m-nster-germany","petah-tikva-israel","jerusalem-israel","genoa-italy","naples-italy","rome-italy","messina-italy","bu-japan","kashiwa-shi-japan","kurume-shi-japan","maebashi-japan","kumamoto-japan","izumi-shi-japan","saitama-shi-japan","bunkyo-ku-japan","fuchu-shi-japan","setagaya-city-japan","amsterdam-netherlands","torun-poland","warsaw-poland","dorado-puerto-rico","san-juan-puerto-rico","seoul-south-korea","daegu-south-korea","ferrol-spain","madrid-spain","m-laga-spain","stockholm-sweden","gothenburg-sweden","zurich-switzerland","bern-switzerland","changhua-city-changhua-county-taiwan","taipei-taiwan","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","kocaeli-turkey-t-rkiye","sheffield-united-kingdom","london-united-kingdom","birmingham-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Risankizumab for Crohn's Disease","inPlainEnglish":"Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, how well it works, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to \\< 18 years old who have had intolerance or inadequate response to other therapies.","whoItsFor":["Ages 2 Years to 17 Years","Pediatric individuals, 2 to \\< 18 years old","Must have moderately to severely active CD, as defined by the PCDAI score \\> 30 assessed at Baseline","Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)"],"whoShouldSkip":["History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class","Any of the following medical disorders:","Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD","A diagnosis of CD prior to 2 years of age","A diagnosis or suspected diagnosis of a primary immunodeficiency","Currently known complications of CD such as:","Active abscess (abdominal or perianal);"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 110 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.574Z"},{"nctId":"NCT06001814","title":"Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV","officialTitle":"Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called \"One Mind One Heart\" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.","conditions":["Hiv","Cardiovascular Diseases"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"One-Mind One-Heart"},{"type":"OTHER","name":"Education"}],"enrollment":50,"startDate":"2025-07-21","completionDate":"2028-06-30","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. age ≥50 years\n2. clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription\n3. viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months\n4. current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \\[K10\\]) screener)\n5. ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol\n6. access to cell phone with text messaging capabilities\n\nExclusion Criteria:\n\n1. non-English-speaking\n2. cognitive impairments preventing informed consent\n3. untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jacklyn Foley, PhD","phone":"857-347-5312","email":"jdfoley@mgh.harvard.edu"}],"primaryOutcomes":["Feasibility of recruitment","Feasibility of eligibility criteria","Feasibility of randomization","Feasibility of the OM-OM intervention","Feasibility of research assessments","Feasibility of blood draws","Acceptability of OM-OH intervention","Acceptability of text-enhanced delivery","Acceptability of blood draws"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: One-Mind One-Heart for Hiv","inPlainEnglish":"Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors.","whoItsFor":["Ages 50 Years to any","clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription","viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months","current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \\[K10\\]) screener)","≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol","access to cell phone with text messaging capabilities"],"whoShouldSkip":["non-English-speaking","untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview"],"whatHappens":"If you join, the listed intervention(s) are One-Mind One-Heart, or Education. The registry lists allocation as randomized. Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.526Z"},{"nctId":"NCT06002659","title":"CAR20(NAP)-T Therapy for B Cell Lymphoma (CARMA-01 Study)","officialTitle":"A Phase I/IIa Multicenter Study Evaluating the Safety and Efficacy of CAR20(NAP)-T in Patients With Relapsed/Refractory B Cell Lymphoma (CARMA-01 Study)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Uppsala University","sponsorClass":"OTHER","summary":"The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CAR20(NAP)-T for patients with B-cell malignancies.","conditions":["B-cell Lymphoma"],"keywords":["CAR T cell","B cell lymphoma","CD20","HP-NAP"],"interventions":[{"type":"BIOLOGICAL","name":"CAR20(NAP)-T"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"}],"enrollment":18,"startDate":"2024-05-01","completionDate":"2028-12-30","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Signed informed consent.\n* Relapsed or refractory CD20+ large B-cell lymphoma (DLBCL, NOS or high-grade malignant B-cell lymphoma), mantle cell lymphoma or indolent lymphoma.\n* The patient should have been treated with at least one line of therapy and have no curative treatment option, assessed by the Investigator and documented in the source data prior to enrolment, specifically:\n\n  1. Relapsed or refractory CD20+ B-cell lymphoma that are not suitable to receive clinically approved CD19-directed CAR T cell treatment\n  2. Relapsed or refractory CD20+ B-cell lymphoma who are considered CD19 neg-ative\n  3. Relapsed or refractory B-cell lymphoma who relapse after CD19-directed CAR T cell treatment\n  4. Not suitable for autologous stem cell transplant\n  5. Relapsed after allogeneic transplantation\n* In phase I age \\>18 years, in phase II all ages.\n* Measurable disease per Lugano classification.\n* Performance status ECOG 0-2.\n* Bone marrow function, if impairment is not caused by lymphoma infiltration, as evidenced by:\n\n  1. Absolute neutrophil count (ANC) ≥ 1x109/L\n  2. Platelet ≥ 50x 109/L\n  3. Absolute lymphocyte count ≥ 0.1x109/L\n* Adequate renal, hepatic, cardiac, and pulmonary function as evidenced by:\n\n  1. Creatinine clearance (Cockcroft Gault) ≥ 30 mL/min\n  2. Serum Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) ≤ 2.5 Upper limit of normal (ULN) and S-Bilirubin \\<1.5x UNL\n  3. Cardiac ejection fraction ≥ 40%\n* Functional venous access for administration of IMP.\n* Fertile individuals must consent to use contraceptives during participation in the trial.\n\nExclusion Criteria:\n\n* Other CD20-positive lymphomas e.g Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation)\n* Any significant medical or psychiatric illness that would prevent the subject from giving informed consent or from following the study procedures.\n* Known human immunodeficiency virus (HIV) infection.\n* Impending organ-compromising disease.\n* Rapidly progressing disease\n* Active and/or severe infection (e.g., tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the subject to tolerate the treatment.\n* Treatment with an investigational product within 30 days prior to enrolment\n* Potential sign of hypersensitivity reaction to tocilizumab or any of the agents used in this study\n* Systemic corticosteroid treatment (\\>10mg/day) \\<5 days prior to IMP treatment or \\<7 days prior leukapheresis.\n* Pregnancy","locations":[{"facility":"Karolinska University Hospital","city":"Stockholm","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uppsala University Hospital","city":"Uppsala","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gunilla Enblad, MD/PhD","phone":"+46186110000","email":"gunilla.enblad@igp.uu.se"},{"name":"Di Yu, PhD","phone":"+46707204196","email":"di.yu@igp.uu.se"}],"primaryOutcomes":["Incidence of dose limiting toxicity","Adverse events","Pharmacodynamic (PD) and pharmacokinetic (PK)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["stockholm-sweden","uppsala-sweden"],"enrichment":{"headline":"Phase 1 / Phase 2: testing CAR20(NAP)-T for B-cell Lymphoma","inPlainEnglish":"The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and how well it works of CAR20(NAP)-T for patients with B-cell malignancies.","whoItsFor":["Relapsed or refractory CD20+ large B-cell lymphoma (DLBCL, NOS or high-grade malignant B-cell lymphoma), mantle cell lymphoma or indolent lymphoma","The patient should have been treated with at least one line of therapy and have no curative treatment option, assessed by the Investigator and documented in the source data prior to enrolment, specifically:","Relapsed or refractory CD20+ B-cell lymphoma that are not suitable to receive clinically approved CD19-directed CAR T cell treatment","Relapsed or refractory CD20+ B-cell lymphoma who are considered CD19 neg-ative","Relapsed or refractory B-cell lymphoma who relapse after CD19-directed CAR T cell treatment","Not suitable for autologous stem cell transplant","Relapsed after allogeneic transplantation"],"whoShouldSkip":["Other CD20-positive lymphomas e.g Burkitt lymphoma, primary CNS lymphoma, plasmablastic lymphoma or CLL transformed to DLBCL/HGBL (Richter transformation)","Known human immunodeficiency virus (HIV) infection","Impending organ-compromising disease","Rapidly progressing disease","Active and/or severe infection (e.g., tuberculosis, sepsis and opportunistic infections, active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection","Other serious underlying medical conditions, which, in the Investigator's judgment, could impair the ability of the subject to tolerate the treatment","Treatment with an investigational product within 30 days prior to enrolment"],"whatHappens":"If you join, the listed intervention(s) are CAR20(NAP)-T, Cyclophosphamide, or Fludarabine. The registry lists allocation as na. The purpose is to study the safety, tolerability, pharmacokinetics, pharmacodynamics and how well it works of CAR20(NAP)-T for patients with B-cell malignancies.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 18 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.145Z"},{"nctId":"NCT06004011","title":"AYAHIV Role-based Responsibilities for Oncology-focused Workforce (ARROW)","officialTitle":"Integrated Delivery of Cancer Control Interventions for Adolescents and Young Adults Living With HIV in Zambia","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Implenomics","sponsorClass":"OTHER","summary":"Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort. In this study, the investigators will test peer-to-peer education and support strategies to increase use of early diagnosis services in HIV treatment facilities and improve compliance with cancer treatment in the cancer center.","conditions":["Cervical Cancer","Kaposi Sarcoma","Non Hodgkin Lymphoma"],"keywords":["cancer screening","Implementation trial"],"interventions":[{"type":"OTHER","name":"ARROW strategies"},{"type":"OTHER","name":"One-time education"}],"enrollment":4100,"startDate":"2024-05-01","completionDate":"2026-12-31","sex":"ALL","minAge":"15 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration\n\nExclusion Criteria:\n\n* pregnant at study enrolment","locations":[{"facility":"Public Health Facilities","city":"Lusaka","state":"","country":"Zambia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sujha Subramanian","phone":"3022225034","email":"sujha.subramanian@implenomics.com"}],"primaryOutcomes":["Proportion who complete screening/physical examination","Proportion who complete recommended cancer treatment modalities"],"hasResults":false,"conditionSlugs":["lymphoma","cervical-cancer","hiv"],"drugSlugs":[],"locationSlugs":["lusaka-zambia"],"enrichment":{"headline":"Not a traditional drug phase: ARROW strategies for Cervical Cancer","inPlainEnglish":"Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers. In Zambia, because of multilevel barriers, interventions for early diagnosis and optimized treatment to reduce this cancer mortality are underutilized for this disproportionally impacted cohort.","whoItsFor":["Ages 15 Years to 39 Years","15 to 39 years of age at the time of study enrolment, on antiretroviral medication (ART) for at least 6 months and with no pending plans to move from current residence during the 3-year study duration"],"whoShouldSkip":["pregnant at study enrolment"],"whatHappens":"If you join, the listed intervention(s) are ARROW strategies, or One-time education. The registry lists allocation as randomized. Adolescents and young adults living with HIV experience higher premature mortality from cancer than their uninfected peers.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 4,100 people at Lusaka. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.535Z"},{"nctId":"NCT06006039","title":"The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.","officialTitle":"An Explorative Study to Examine the Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Disease.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","sponsorClass":"OTHER","summary":"Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies. Discovery and development of effective therapies to treat IBDs depend first on a better understanding of the underlying mechanisms, including how proinflammatory cells proliferate unchecked.\n\nIt has been established that the cytokine interleukin (IL)-23 plays a pivotal role in IBD pathophysiology and antibodies targeting IL-23 are currently in late stage development for the treatment of both CD and ulcerative colitis (UC). IL-23 is part of the IL-12 family of cytokines (which includes IL-12, IL-27 and IL-35). The p40 subunit is shared among IL-23 and IL-12; the p19 subunit is unique to IL-23. Thus far, the efficacy of selective anti-IL-23 blockade (via anti-p19 antibodies) appears 5-10% better with respect to clinical and endoscopic outcomes than targeting both IL-23 and IL-12 using anti-p40 antibodies. Understanding the effects of IL-23 (and IL-12) in IBDs requires identification of the most relevant immune cells that respond to these cytokines. One likely cell type controlled by the IL-23 pathway are innate lymphoid cells (ILCs). ILC3s (a subset of ILCs) are dominant in healthy intestinal tissue and capable of producing IL-22 which maintain intestinal epithelial homeostasis. Disturbances in the amounts of IL-22 caused by changes in the stimulatory cytokine IL-23 in tissues, may therefore cause inflammatory responses. IL-23 may facilitate the IL-12-induced shift of ILC3s to ILC1s which are contributing to the disease-causing chronic inflammation.\n\nThe DIVE 23 project is designed to understand the role of IL-23 in human IBD, in particular CD. It is hypothesized that IL-23R+ cells in the gut, are drivers of chronic inflammation in CD and determine the impact of IL-23 inhibition. To this end the investigators plan to extensively characterize the IL-23-responsive cell populations in inflamed and non-inflamed intestinal tissues of CD patients with postoperative recurrence in order to identify IL-23-responsive immune cell populations that are associated with disease activity. Patients will be treated in routine medical practice with biological agents and will undergo a second ileocolonoscopy 12-16 weeks later to investigate the impact of the different interventions on the mucosal immunology driving CD.","conditions":["Crohn´s Disease"],"keywords":["Crohn's Disease","Interleukin-23","Postoperative recurrence"],"interventions":[],"enrollment":40,"startDate":"2023-06-05","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>/= 18 years;\n* Male or non-pregnant, non-lactating females;\n* Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score \\>i2a) in the neoterminal ileum;\n* In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements;\n* The subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures.\n\nExclusion Criteria:\n\n* Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures;\n* Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association \\[NYHA\\], multiple sclerosis, active infections).\n* Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.\n* Currently participating or planning to participate in a study involving an investigational product.\n* Active or planned pregnancy during the study.\n* Prior diagnosis of dysplasia in the colon (excluding in resected adenomas).\n* History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer.\n* Received a biologic treatment between surgery and first endoscopy.\n* Positive Clostridium difficile toxin B in faeces. Patients who test positive can be treated per local practice and still enter the study if no longer than 4 weeks after the screening visit, they test negative for Clostridium difficile toxin B.\n* Presence of a stoma without ileocolonic anastomosis or pouch.\n* Active perianal abscess or draining fistula\n* ALT or AST \\> 3x the upper limit of normal measured at screening\n* Increased risk of bleeding: coagulation disorder, use of anticoagulants and DOACs","locations":[{"facility":"Mount Sinai","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lotte Oldenburg","phone":"020 444 1125","email":"l.oldenburg@amsterdamumc.nl"}],"primaryOutcomes":["Changes in concentration and amounts of IL-23 responsive cells in postoperative CD at baseline endoscopy and after 12-16 weeks of routine care treatment with a biological agent."],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["toronto-canada","amsterdam-netherlands"],"enrichment":{"headline":"The Role of IL-23-Responsive Immune Cell Subsets in Post-Operative Recurrence in Patients With Crohn's Dise…","inPlainEnglish":"Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.","whoItsFor":["Ages 18 Years to any","Male or non-pregnant, non-lactating females;","Patients with postoperative recurrence at routine endoscopy 6-24 months following resection, defined by presence of ulcerations (endoscopic Rutgeerts' score \\>i2a) in the neoterminal ileum;","In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements;"],"whoShouldSkip":["Any conditions (eg, history of alcohol or substance abuse, or lack of compliance) which, in the opinion of the investigator, may interfere with the patient's ability to comply with study procedures;","Any condition in which one of the potential treatments are contraindicated in the opinion of the investigator (eg, cardiac failure class 3-4 according to the New York Heart Association \\[NYHA\\], multiple sclerosis, active infections)","Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer","Currently participating or planning to participate in a study involving an investigational product","Active or planned pregnancy during the study","Prior diagnosis of dysplasia in the colon (excluding in resected adenomas)","History of malignancy in the 3 years prior to randomization except for non-melanoma skin cancer"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.889Z"},{"nctId":"NCT06007872","title":"Intracardiac Echocardiography Guided Watchman Device Implant","officialTitle":"Feasibility: Intracardiac Echocardiography Guided Watchman Device Implant","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Cleveland Clinic","sponsorClass":"OTHER","summary":"This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients. This study is aiming to show how the ICE is just as effective in placing the device correctly and effectively.","conditions":["Atrial Fibrillation","Left Atrial Appendage Thrombosis"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Intracardiac Echocardiography (ICE)"}],"enrollment":100,"startDate":"2022-12-02","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial\n\nExclusion Criteria:\n\n* Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed.\n* Patients receiving a concomitant ablation procedure\n* Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures\n* Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place).","locations":[{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Oussama Wazni, MD","phone":"216-444-2131","email":"waznio@ccf.org"}],"primaryOutcomes":["Successful Watchman implantation using intracardiac echocardiography (ICE) guidance"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Intracardiac Echocardiography (ICE) for Atrial Fibrillation","inPlainEnglish":"This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure. Currently the process is to use a Transesophageal Echocardiography (TEE) to place the Watchman in patients.","whoItsFor":["Ages 18 Years to any","All patients who meet guideline established criteria for commercially available Watchman device implant and not enrolled in an active clinical trial"],"whoShouldSkip":["Patients in whom a procedural TEE cannot be performed and an ICE only implant is needed","Patients receiving a concomitant ablation procedure","Patients with prior incomplete surgical or percutaneous left atrial appendage ligation/exclusion procedures","Patients in whom the delivery of trans-septal equipment is anticipated to be difficult (e.g. patent foramen ovale (PFO) or atrial septal defect (ASD) closure devices in place)"],"whatHappens":"If you join, the listed intervention(s) are Intracardiac Echocardiography (ICE). The registry lists allocation as na. This study is to look at the success of Intracardiac Echocardiography (ICE) in the Watchman procedure.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Cleveland. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.734Z"},{"nctId":"NCT06009874","title":"Clinical Investigation of the Cardioprotective Effect of Early Administration of SGLT2 in Patients Presented With AMI","officialTitle":"Clinical Investigation of Cardioprotective Effect of Early Administration of Sodium-glucose Cotransport-2 Inhibitors in Patients With Acute Myocardial Infarction","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Mohammad Hussien Tantawy Soliman","sponsorClass":"OTHER","summary":"This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.","conditions":["Myocardial Infarction"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dapagliflozin 10mg Tab"},{"type":"DRUG","name":"Placebo"}],"enrollment":80,"startDate":"2023-12-20","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with ST-elevation myocardial infarction (STEMI).\n2. STEMI was defined according to the Fourth Universal Definition of AMI.\n3. 18 - 80 years of age.\n4. Diabetics or non-diabetics.\n5. eGFR \\> 45 ml/min/1.73m2.\n6. Blood pressure before first drug dosing \\>110/70 mmHg.\n\nExclusion Criteria:\n\n1. Cardiogenic shock.\n2. Hypoglycemia.\n3. History of diabetic ketoacidosis.\n4. Genital and urinary infections.\n5. History of AMI.\n6. Stent thrombosis.\n7. Previous coronary artery bypass surgery.\n8. Severe hepatic insufficiency.\n9. Advanced cancer patients.\n10. Blood pH \\< 7.32.\n11. Known allergy to SGLT-2 inhibitors.\n12. Hemodynamic instability.\n13. Females of childbearing potential without adequate contraceptive methods.\n14. Patients currently on or have received any SGLT-2 inhibitors.","locations":[{"facility":"Mohammad Soliman","city":"Shibīn al Kawm","state":"Menofia","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mohammad Soliman","phone":"+201003474565","email":"dr.mhtantawy@gmail.com"}],"primaryOutcomes":["difference in infarct size","difference in NT-proBNP level"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dapagliflozin"],"locationSlugs":["shib-n-al-kawm-egypt"],"enrichment":{"headline":"Not a traditional drug phase: testing Dapagliflozin 10mg Tab for Myocardial Infarction","inPlainEnglish":"This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.","whoItsFor":["Ages 18 Years to 80 Years","Patients with ST-elevation myocardial infarction (STEMI)","STEMI was defined according to the Fourth Universal Definition of AMI","18 - 80 years of age","Diabetics or non-diabetics","eGFR \\> 45 ml/min/1.73m2","Blood pressure before first drug dosing \\>110/70 mmHg"],"whoShouldSkip":["History of diabetic ketoacidosis","Genital and urinary infections","Previous coronary artery bypass surgery","Severe hepatic insufficiency","Advanced cancer patients","Known allergy to SGLT-2 inhibitors","Hemodynamic instability"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin 10mg Tab, or Placebo. The registry lists allocation as randomized. This study aims to investigate the effect of early administration of DAPA during ischemia and before pPCI on infarct size, reperfusion injury-related myocardial damage, cardioprotection from HF, and renoprotection from AKI in patients with AMI.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Shibīn al Kawm. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.962Z"},{"nctId":"NCT06014827","title":"Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma","officialTitle":"Phase II Trial of the Addition of Biologically Guided Radiation Therapy (BgRT) and Stereotactic Body Radiation Therapy (SBRT) to Tyrosine Kinase Inhibitor in Oligoprogressive Oncogenic Positive Non-Small Cell Lung Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Osimertinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving BgRT with SBRT and osimertinib may kill more tumor cells in patients with oligoprogressive EGFR positive non-small cell lung carcinoma.","conditions":["Lung Non-Small Cell Carcinoma","Stage IV Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Osimertinib"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy"},{"type":"OTHER","name":"Survey Administration"}],"enrollment":32,"startDate":"2024-10-21","completionDate":"2027-03-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: \\>= 18 years\n* Eastern Cooperative Oncology Group (ECOG) =\\< 2\n* Histologically confirmed advanced non-small cell lung cancer (NSCLC)\n* The tumor harbors 1 of the 2 common epidermal growth factor receptor (EGFR) mutations known to be associated with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) sensitivity (Ex19del or L858R), either alone or in combination with other epidermal growth factor receptor (EGFR) mutations, which may include T790M.\n* Disease progression in the metastatic setting on PET or CT imaging when receiving first line standard/approved single agent osimertinib after having had stable disease (per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] version \\[v\\] 1.1 or PET Response Criteria in Solid Tumors \\[PERCIST\\] v 1.0) for more than 6 months\n* Disease progression must be in the form of 1-5 extracranial sites (any number of metastatic sites at initial diagnosis will qualify). For progression of the primary and oligoprogressive site(s), the primary should be treated with curative/local control intent. The primary, if progressing is considered as 1 site. Maximum of 3 lesions per organ (i.e. patient with 4 oligoprogressive sites in the lung would be excluded). Each lesion will be considered as 1 \"site\" so 3 lesions in the lung for example will be considered 3 sites. Patients with prior metastases that have been treated with ablative therapies before their current line of systemic therapy are eligible. Patients with brain metastases can be included but brain metastases must be treated (asymptomatic and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug) prior to enrollment (brain metastases \\[mets\\] will not be counted as a site of progression)\n* Lesion(s) must be amenable to SBRT as determined by the radiation oncologist. If a patient is unable to receive a minimum of 30 Gy in 5 fractions they will not qualify\n* At least one lesion must be amenable to BgRT which includes either a lung or bone metastasis, greater than or equal to 2 cm, which can also receive a minimum of 30 Gy in 5 fractions\n* No prior systemic therapy for advanced disease other than osimertinib\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n* Patients must be able to swallow and retain oral medications\n* Life expectancy of at least 6 months\n\nExclusion Criteria:\n\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy (6 weeks for nitrosoureas or mitomycin C). Exceptions to this exclusion are brain radiation (2 weeks) and osimertinib\n* Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy\n* Patients receiving class 1A or class III antiarrhythmic agents within 14 days prior to day 1 of protocol therapy\n* Drugs known to prolong the corrected QT (QTc) interval\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection requiring antibiotics bacterial, viral, or fungal infections, requiring systemic therapy\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection\n* Prior malignancy other than carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated 5 or more years prior to study entry with no subsequent evidence of recurrence. Patients with a history of low grade (Gleason score =\\< 6 =Gleason group 1) localized prostate cancer will be eligible even if diagnosed less than 5 years prior to study entry. Other malignancies with low probability of recurrence may be allowed with primary investigator (PI) approval\n* Females only: Pregnant or breastfeeding\n* Any malabsorption condition\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Diagnosis of congenital long QT syndrome\n* New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months, unstable arrhythmia, or evidence of ischemia on electrocardiogram (ECG)\n* Clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroid medication for 1 week prior to the first dose of study drug and have completed radiation 2 weeks prior to the first dose of study drug\n* Patients with active interstitial lung disease (ILD) / pneumonitis or with a history of ILD/ pneumonitis requiring steroids\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Percent of patients on planned protocol treatment"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["osimertinib"],"locationSlugs":["duarte-california","new-haven-connecticut"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive). BgRT is radiation that uses specialized imaging to during treatment to target the active tumor and direct radiation to tumors in order to kill and shrink tumor cells.","whoItsFor":["Ages 18 Years to any","Assent, when appropriate, will be obtained per institutional guidelines","Eastern Cooperative Oncology Group (ECOG) =\\< 2","Histologically confirmed advanced non-small cell lung cancer (NSCLC)","Lesion(s) must be amenable to SBRT as determined by the radiation oncologist. If a patient is unable to receive a minimum of 30 Gy in 5 fractions they will not qualify","At least one lesion must be amenable to BgRT which includes either a lung or bone metastasis, greater than or equal to 2 cm, which can also receive a minimum of 30 Gy in 5 fractions","No prior systemic therapy for advanced disease other than osimertinib","Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required"],"whoShouldSkip":["Chemotherapy, radiation therapy, biological therapy, immunotherapy within 21 days prior to day 1 of protocol therapy (6 weeks for nitrosoureas or mitomycin C). Exceptions to this exclusion are brain radiation (2 weeks) and osimertinib","Strong CYP3A4 inducers/ inhibitors within 14 days prior to day 1 of protocol therapy","Patients receiving class 1A or class III antiarrhythmic agents within 14 days prior to day 1 of protocol therapy","Drugs known to prolong the corrected QT (QTc) interval","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent","Clinically significant uncontrolled illness","Active infection requiring antibiotics bacterial, viral, or fungal infections, requiring systemic therapy"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Osimertinib. The registry lists allocation as na. This phase II trial tests how well biologically guided radiation therapy (BgRT) and stereotactic body radiation therapy (SBRT) with osimertinib works for the treatment of EGFR positive non-small cell lung carcinoma that has spread from where it first started (primary site) to a limited number of anatomic sites (oligoprogressive).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.678Z"},{"nctId":"NCT06021197","title":"NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia","officialTitle":"NMDA-enhancing Treatment for Cognitive Dysfunction of Schizophrenia Patients During Symptomatic Remission","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"China Medical University Hospital","sponsorClass":"OTHER","summary":"Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia (CIAS) is an important therapeutic target, hypofunction of N-methyl-D-aspartate receptor (NMDAR) is a key factor of CIAS. This study aims to examine the efficacy and safety of an NMDA-enhancer (NMDAE) for the treatment of CIAS in schizophrenia patients during symptomatic remission.","conditions":["Schizophrenia"],"keywords":["Schizophrenia","NMDA","Symptomatic remission"],"interventions":[{"type":"DRUG","name":"NMDAE"},{"type":"DRUG","name":"Placebo Cap"}],"enrollment":90,"startDate":"2023-10-12","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia\n* Fulfill the Remission in Schizophrenia Working Group (RSWG) criteria for remission (Andreasen et al., 2005): each of eight items (delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, passive/apathetic social withdrawal, and lack of spontaneity and flow of conversation) in the Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987) scoring 3 or lower for 6 months or longer; in addition, have a baseline total score of 59 or lower in the PANSS\n* Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;\n* Have been keeping a fixed dose of antipsychotics (excluding clozapine) for at least 6 months, and that is not allowed to change during the 12-week study period\n* Have sufficient education to communicate effectively and are capable of completing the assessments of the study\n* Agree to participate in the study and provide written informed consent\n\nExclusion Criteria:\n\n* DSM-5-TR diagnosis of intellectual disability or substance (including alcohol) use disorder\n* History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study\n* Pregnancy or lactation\n* Inability to follow protocol","locations":[{"facility":"Department of Psychiatry, China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hsien-Yuan Lane, M.D., Ph.D","phone":"886 4 22052121","email":"hylane@gmail.com"}],"primaryOutcomes":["Change of cognitive function composite"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["taichung-taiwan"],"enrichment":{"headline":"Phase 2: testing NMDAE for Schizophrenia","inPlainEnglish":"Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission. While cognitive impairment associated with schizophrenia (CIAS) is an important therapeutic target, hypofunction of N-methyl-D-aspartate receptor (NMDAR) is a key factor of CIAS.","whoItsFor":["Ages 18 Years to 65 Years","Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5 -TR) diagnosis of schizophrenia","Are physically healthy and laboratory assessments (including blood routine, biochemical tests) are clinically insignificant;","Have been keeping a fixed dose of antipsychotics (excluding clozapine) for at least 6 months, and that is not allowed to change during the 12-week study period","Have sufficient education to communicate effectively and are capable of completing the assessments of the study"],"whoShouldSkip":["DSM-5-TR diagnosis of intellectual disability or substance (including alcohol) use disorder","History of epilepsy, head trauma, or serious medical or central nervous system diseases (other than schizophrenia) which may interfere with the study","Pregnancy or lactation","Inability to follow protocol"],"whatHappens":"If you join, the listed intervention(s) are NMDAE, or Placebo Cap. The registry lists allocation as randomized. Cognitive impairment, the core psychopathology of schizophrenia, usually persists in schizophrenia patients even during symptomatic remission.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at Taichung. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.048Z"},{"nctId":"NCT06023589","title":"A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma","officialTitle":"A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.","conditions":["Asthma"],"keywords":["Asthma","Uncontrolled Asthma","Severe Uncontrolled Asthma","Human monoclonal antibody (IgG2λ) cytokine"],"interventions":[{"type":"BIOLOGICAL","name":"Tezepelumab"},{"type":"OTHER","name":"Placebo"}],"enrollment":231,"startDate":"2023-08-24","completionDate":"2028-05-31","sex":"ALL","minAge":"5 Years","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.\n2. Participants must be 5 to \\< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.\n3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.\n4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.\n6. Supportive evidence of asthma as documented by one of the following:\n\n   1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.\n\n      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:\n   2. Post-BD responsiveness of FEV1 ≥ 10%.\n   3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.\n   4. PEF average daily diurnal variability \\> 13% over a 2-week period.\n   5. Variability of FEV1 ≥ 12% between any two clinical visits.\n   6. Positive exercise challenge test (defined as a fall in FEV1 of \\> 12%).\n   7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.\n7. History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1.\n8. Pre-BD FEV1 \\>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.\n9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:\n\n   1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.\n   2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.\n   3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.\n   4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.\n10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).\n\nExclusion Criteria:\n\n1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.\n2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.\n4. Change in ICS dose within 1 month prior to Visit 1.\n5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.","locations":[{"facility":"Research Site","city":"Montgomery","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"La Jolla","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Orange","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"San 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3: testing Tezepelumab for Asthma","inPlainEnglish":"To assess the how well it works and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.","whoItsFor":["Ages 5 Years to 11 Years","Participants must be 5 to \\< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3","Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1","Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1","Supportive evidence of asthma as documented by one of the following:","Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2","If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:","Post-BD responsiveness of FEV1 ≥ 10%"],"whoShouldSkip":["History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis","History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study","History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1","Change in ICS dose within 1 month prior to Visit 1","History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab, or Placebo. The registry lists allocation as randomized. To assess the how well it works and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 231 people at 131 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.337Z"},{"nctId":"NCT06024746","title":"A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients With Heart Failure (CONFIRMATION-HF)","officialTitle":"Combined Efficacy and Safety of an Early, Intensive, Management Strategy With Finerenone and SGLT2 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age of majority if \\>18 years in the participant's country of residence\n* Current hospitalization or recently discharged with the primary diagnosis of heart failure\n* Heart failure signs and symptoms at the time of hospital admission\n* Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission\n* Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)\n* Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).\n* Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis\n* Documented prior history of severe hyperkalemia in the setting of MRA use\n* Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i\n* Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m² and/or potassium \\>5.0 mmol/L\n* Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days\n* Prior or planned heart transplant\n* Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure\n* Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction\n* Probable alternative cause of participant's heart failure symptoms\n* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers\n* Known hypersensitivity to the IP (active substance or excipients)\n* Any other condition or therapy which would make the patient unsuitable for this study","locations":[{"facility":"CON-10004 Fairhope, AL Investigational Site","city":"Fairhope","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoenix, AZ Investigative Site CON-10115","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chula Vista, CA Investigative Site CON-10111","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-10075 El Centro, CA Investigational Site","city":"El Centro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-10024 Sacramento, CA 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Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21008, Caxias do Sul, Rio Grande do Sul","city":"Caxias do Sul","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21042, Passo Fundo, Rio Grande do Sul","city":"Passo Fundo","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Porto Alegre, RS Investigative Site CON-21025","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Porto Velho, Rondonia Investigative Site CON-21087","city":"Porto Velho","state":"Rondônia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21007 Joinville, Santa Catarina Investigational Site","city":"Joinville","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21058, Aracaju, Sergipe","city":"Aracaju","state":"Sergipe","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21057, Atibaia, São Paulo","city":"Atibaia","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21004 Braganca Paulista, Sao Paulo Investigational Site","city":"Bragança Paulista","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Campinas, São Paulo Investigative Site CON-21083","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21005, Itaquera, São Paulo","city":"Itaquera","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21010, Osasco, São Paulo","city":"Osasco","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21011, Presidente Prudente, São Paulo","city":"Presidente Prudente","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON021043, Santo André, São Paulo","city":"Santo André","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"São Carlos, São Paulo Investigative Site CON-21075","city":"São Carlos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"São José dos Campos, São Paulo Investigative Site CON-21081","city":"São José dos Campos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21074, São Paulo, São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21062, São Paulo, São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21037, São Paulo, São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21048, São Paulo, São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21049 Sao Paulo, Sao Paulo Investigational Site","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-21031, Votuporanga, São Paulo","city":"Votuporanga","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Porto Alegre, RS Investigative Site CON-21019","city":"Porto Alegre","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"São Paulo Investigative Site CON-21066","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11011, Edmonton, AB","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11012 Surry, BC Investigational Site","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11016, Sudbury, ON","city":"Greater Sudbury","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11010, London, ON","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11007 North York, ON Investigational Site","city":"North York","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11008, Toronto, ON","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11019, Toronto, ON","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11001, Toronto, ON","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11026, Montreal, Quebec","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-11005 Sherbrooke, QC Investigational Site","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56002, Guangzhou, Guangdong province","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56008, Changsha, Hunan","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56004, Jinan, Shandong Province","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56001, Shanghai, Shanghai","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56009, Shanghai, Shanghai","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56005, Taiyuan, Shanxi province","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56006, Xi'an city, Shanxi Province","city":"Xian City","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56007, Chengdu City, Sichuan Province","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56003, Tianjin, Tianjin","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-56010, Hangzhou, Zhejiang Province","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai, China Investigative Site CON-56011","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-51006, Ahmedabad, Gujarat","city":"Ahmedabad","state":"Gujarat","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-51013, Bangalore, Karnataka","city":"Bangalore","state":"Karnataka","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-51009, Nagpur, Maharashtra","city":"Nagpur","state":"Maharashtra","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Delhi, Delhi Investigative Site CON-51011","city":"New Delhi","state":"National Capital Territory of Delhi","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Delhi, Delhi Investigative Site CON-51004","city":"New Delhi","state":"","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"A Coruña, Galicia Investigative Site CON-38004","city":"A Coruña","state":"Galicia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38008, Santiago de Compostela, Galicia","city":"Santiago de Compostela","state":"Galicia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38002, Madrid, Madrid","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38011, Madrid, Madrid","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38012, Malaga, Malaga","city":"Málaga","state":"Malaga","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38009, Manises, Valencia","city":"Manises","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-38001, Valencia, Valencia","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barcelona Investigative Site CON-38010","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valencia Investigative Site CON-38007","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-54001, Kandy, Central Province","city":"Kandy","state":"Central Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colombo, Western Province, Investigative Site CON-54006","city":"Colombo","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-54005, Colombo, Western Province","city":"Colombo","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-54007, Colombo, Western Province","city":"Colombo","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-54008, Ragama, Western Province","city":"Ragama","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-39010, Bournemouth, Dorset","city":"Bournemouth","state":"Dorset","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-39002, London, UK","city":"London","state":"UK","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-39007, Bristol, UK","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"CON-39001, Glasgow, UK","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marc Bonaca","phone":"(303) 860-9900","email":"info@cpcmed.org"}],"primaryOutcomes":["Clinical benefit","Number of serious adverse events (AEs).","Number of adverse events leading to discontinuation of study drug."],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":["empagliflozin"],"locationSlugs":["fairhope-alabama","phoenix-arizona","chula-vista-california","el-centro-california","sacramento-california","san-francisco-california","van-nuys-california","aurora-colorado","denver-colorado","bradenton-florida","fort-lauderdale-florida","hialeah-florida","miami-florida","miramar-florida","atlanta-georgia","glenview-illinois","island-lake-illinois","naperville-illinois","peoria-illinois","merrillville-indiana","lexington-kentucky","louisville-kentucky","paducah-kentucky","baton-rouge-louisiana","west-monroe-louisiana","minneapolis-minnesota","kansas-city-missouri","omaha-nebraska","charlotte-north-carolina","greenville-north-carolina","morrisville-north-carolina","centerville-ohio","philadelphia-pennsylvania","chattanooga-tennessee","amarillo-texas","austin-texas","denison-texas","fort-worth-texas","houston-texas","texarkana-texas","layton-utah","norfolk-virginia","salem-virginia","rio-branco-brazil","arapiraca-brazil","fortaleza-brazil","linhares-brazil","vila-velha-brazil","salvador-brazil","bras-lia-brazil","aparecida-de-goi-nia-brazil","goi-nia-brazil","belo-horizonte-brazil","po-os-de-caldas-brazil","curitiba-brazil","londrina-brazil","recife-brazil","teresina-brazil","rio-de-janeiro-brazil","natal-brazil","caxias-do-sul-brazil","passo-fundo-brazil","porto-alegre-brazil","porto-velho-brazil","joinville-brazil","aracaju-brazil","atibaia-brazil","bragan-a-paulista-brazil","campinas-brazil","itaquera-brazil","osasco-brazil","presidente-prudente-brazil","santo-andr-brazil","s-o-carlos-brazil","s-o-jos-dos-campos-brazil","s-o-paulo-brazil","votuporanga-brazil","edmonton-canada","surrey-canada","greater-sudbury-canada","london-canada","north-york-canada","toronto-canada","montreal-canada","sherbrooke-canada","guangzhou-china","changsha-china","jinan-china","shanghai-china","taiyuan-china","xian-city-china","chengdu-china","tianjin-china","hangzhou-china","ahmedabad-india","bangalore-india","nagpur-india","new-delhi-india","a-coru-a-spain","santiago-de-compostela-spain","madrid-spain","m-laga-spain","manises-spain","valencia-spain","barcelona-spain","kandy-sri-lanka","colombo-sri-lanka","ragama-sri-lanka","bournemouth-united-kingdom","london-united-kingdom","bristol-united-kingdom","glasgow-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Finerenone for Heart Failure","inPlainEnglish":"Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the how well it works and safety of treatment in patients hospitalized with heart failure.","whoItsFor":["Ages 18 Years to any","Age ≥18 years or legal age of majority if \\>18 years in the participant's country of residence","Current hospitalization or recently discharged with the primary diagnosis of heart failure","Heart failure signs and symptoms at the time of hospital admission","Fulfillment of protocol defined stabilization criteria (if randomly assigned during hospitalization)","Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide)","Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)"],"whoShouldSkip":["Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis","Documented prior history of severe hyperkalemia in the setting of MRA use","Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i","Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m² and/or potassium \\>5.0 mmol/L","Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days","Prior or planned heart transplant","Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure"],"whatHappens":"If you join, the listed intervention(s) are Finerenone, or Empagliflozin. The registry lists allocation as randomized. Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the how well it works and safety of treatment in patients hospitalized with heart failure.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,500 people at 140 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.618Z"},{"nctId":"NCT06029270","title":"Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer","officialTitle":"A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.","conditions":["Metastatic Nasopharyngeal Carcinoma","Recurrent Nasopharyngeal Carcinoma","Stage IV Nasopharyngeal Carcinoma AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Scan"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Gemcitabine"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"BIOLOGICAL","name":"Relatlimab"}],"enrollment":156,"startDate":"2024-07-15","completionDate":"2029-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PRIOR TO STEP 1 REGISTRATION:\n* Pathologically (histologically or cytologically) proven diagnosis of nasopharyngeal carcinoma (NPC) that has recurred locoregionally and/or is present at distant sites. Patients who present with metastatic disease (de novo) at diagnosis are also eligible. For locoregional recurrence, the disease must not be amenable to potentially curative surgery or re-irradiation. Eligible patient must have the following characteristics:\n\n  * Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or\n  * A known history of detectable plasma EBV DNA (via a polymerase chain reaction \\[PCR\\]-based assay) at any time point since the initial diagnosis of NPC.\n* Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated.\n\n  * Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable.\n  * CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated).\n  * Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional.\n  * Symptomatic and active brain metastases and/or leptomeningeal metastasis on CT and/or MRI imaging: Patients who have prior therapies for brain and leptomeningeal metastasis or cord/cauda compression who are clinically stable for \\>= 2 months prior to registration and have discontinued systemic steroids therapy (\\> 10 mg/day prednisone or equivalent) \\> 4 weeks prior to registration are eligible.\n  * Patients with base of skull involvement by NPC are allowed unless their disease is directly invading the brain parenchyma, associated with clinical symptoms and/or significant vasogenic edema on radiological imaging.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status of 0-2.\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal.\n* Absolute neutrophil count (ANC) \\>= 1500 cells/mm\\^3.\n* Platelets \\>= 100,000 cells/mm\\^3.\n* Hemoglobin (Hgb) \\>= 8.0 g/dL (Transfusion is accepted. Erythropoietin dependency not accepted.).\n* Total bilirubin =\\< 1.5 × institutional upper limit of normal (ULN) or direct bilirubin =\\< ULN for patients with total bilirubin levels \\> 1.5 × ULN. Patients with known Gilbert's disease who have serum bilirubin level =\\< 3 × ULN may be enrolled.\n* Alanine transaminase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\< 3 × ULN (=\\< 5 × ULN for patients with liver metastases).\n* Serum creatinine =\\< 1.5 × ULN or calculated creatinine clearance (CrCl) based on Cockcroft-Gault equation \\>= 30 mL/min for patients with serum creatinine levels \\> 1.5 × ULN. Cisplatin or carboplatin may be used at the discretion of the investigator - except for patients with CrCl between 30-50 mL/min, for whom carboplatin should be used instead of cisplatin. CrCl must be \\> 50 mL/min for cisplatin to be used.\n* Albumin-adjusted calcium level based on corrected calcium equation =\\< 1.5 × ULN (patients are allowed to have treatment for hypercalcemia prior to starting treatment).\n* No prior systemic treatment of palliative intent for recurrent/metastatic (R/M) NPC including cytotoxic chemotherapy. Prior treatment for non-recurrent and non-metastatic NPC is allowed. Systemic therapy given prior to curative intent re-irradiation or surgery is allowed for potentially curable locoregional recurrence.\n* No prior treatment with a PD-1 inhibitor (except if given as adjuvant or neoadjuvant therapy for NPC), PD-L1 inhibitor, anti-PD-L2 inhibitor, LAG-3 inhibitor, CTLA-4 inhibitor (except if given as adjuvant or neoadjuvant therapy for non-recurrent and non-metastatic NPC), or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.\n* The interval between the last dose of curative-intent treatment for non-recurrent, non-metastatic NPC, including definitive radiotherapy (RT) and/or induction, concurrent, or adjuvant chemotherapy and recurrence must be ˃ 6 months.\n* Clinically significant toxicities from any prior systemic therapy or radiotherapy must have resolved to grade 0 or 1 as per National Cancer Institute (NCI) CTCAE v 5.0 - except alopecia, dry mouth, dysgeusia, dysphagia, and fatigue. Patients with a history of grade 3-4 cisplatin related neuropathy must have recovered to grade 0-2 prior to registration. Patients with a history of hearing impairment, or ototoxicity from prior cisplatin, of any grade are allowed.\n* No prior palliative RT within 30 days prior to registration unless the irradiated site(s) are not the target lesions. The irradiated site(s) also must not be the only sites of measurable recurrent disease.\n* No major surgical procedures within 30 days prior to registration.\n* No history of unstable angina requiring hospitalization within the last 6 months.\n* No history of myocardial infarction within the last 6 months.\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III/IV are not eligible). Patients with symptomatic coronary artery disease, congestive heart failure or a known history of having a left ventricular ejection fraction \\< 50% must be stably controlled with medication in the opinion of the treating physician, in consultation with a cardiologist if appropriate.\n* No prior history of myocarditis.\n* No active infection requiring IV antibiotics, IV antiviral, or IV antifungal treatments at the time of study registration.\n* No history of (non-infectious) pneumonitis that required steroids or current pneumonitis requiring steroids and/or immunosuppressive therapy, idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans), or idiopathic pneumonitis.\n* No history of multi-drug resistant mycobacterium tuberculosis (TB) or active TB, as defined by systemic treatment received =\\< 2 years prior to registration. Note: Patients who had a history of treated TB ˃ 2 years prior to registration are allowed.\n* No prior solid organ transplant or bone marrow transplant.\n* No conditions requiring systemic treatment with either immunosuppressive doses of corticosteroids (\\> 10 mg daily prednisone or equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid premedication for the prophylaxis of CT contrast-related allergies is allowed. The use of dexamethasone as an anti-emetic premedication prior to chemotherapy is also allowed.\n* No active autoimmune disease requiring systemic treatment (i.e., disease modifying agents, corticosteroids, or immunosuppressive drugs) within the past 2 years. These may include (but not limited to) patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's disease, ulcerative colitis, autoimmune hepatitis, glomerulonephritis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome.\n\n  * Note: Patients are permitted to enroll if they have vitiligo; type I diabetes mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only hormone replacement; alopecia; and/or psoriasis not requiring systemic treatment. Conditions not expected to recur in the absence of an external trigger are permitted to enroll.\n* No prior live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist \\[registered trademark\\]) are live attenuated vaccines and are not allowed. Coronavirus disease 2019 (COVID-19) vaccines that are approved by the local drug regulatory authority of the participating region are allowed.\n* No known history of grade 3-4 allergic reaction or hypersensitivity reaction to cisplatin, carboplatin, or gemcitabine.\n* No known history of grade 4 hypersensitivity (or infusion) reaction to any monoclonal antibody. Patients who had prior grade 3 hypersensitivity (or infusion) reaction but could tolerate resumption of the antibody treatment after appropriate pre-medication are eligible.\n* PRIOR TO STEP 2 REGISTRATION:\n* Collection of plasma EBV DNA at baseline is mandatory for all patients prior to Step 2 registration and induction treatment.\n\n  * Note: Submission of the baseline sample will be batch shipped.\n* PRIOR TO STEP 3 REGISTRATION/RANDOMIZATION: PATIENTS WITHOUT PROGRESSIVE DISEASE (PD) ONLY:\n* All patients must have received minimum of 3 cycles, and up to a maximum of 6 cycles of induction treatment within 20 weeks from cycle 1, day 1 of induction treatment (i.e., patients must have completed all induction treatment within 20 weeks from cycle 1 day 1, including the treatment breaks). Patients must have completed 6 cycles of induction treatment, except in the following circumstances:\n\n  * Significant dose delays as a result of treatment-related toxicities.\n  * Intercurrent illness(s), that rendered the patient unable to continue induction treatment.\n  * Note: If a patient received \\< 6 cycles of induction treatment for reasons other than the above circumstances, they will not be eligible for randomization.\n* A CT scan within 30 days prior to Step 3 registration/randomization is required. If the most recent scan performed is not within this time frame, a repeat scan is required to assess response.\n* Did not meet any criteria that result in permanent discontinuation of study treatment during induction treatment phase.\n* Must meet the criteria for starting/resuming a new cycle of maintenance treatment.\n* Did not experience any nivolumab-related autoimmune toxicities that would result in permanent discontinuation of nivolumab during the induction treatment phase.\n* Collection of the plasma EBV DNA post-induction treatment is mandatory.\n\n  * Note: Submission of the post-induction sample will be batch shipped.","locations":[{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fresno","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medicine of USC Koreatown","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Modesto","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Oncology/Hematology-Newport Beach","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute Palo Alto","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Roseville","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Downtown Commons","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Teresa-San Jose","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente San Leandro","city":"San Leandro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser San Rafael-Gallinas","city":"San Rafael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Medical Center - Santa Clara","city":"Santa Clara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Rosa","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South San Francisco","city":"South San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Vallejo","city":"Vallejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Walnut Creek","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Moanalua Medical Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Boise","city":"Boise","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Caldwell","city":"Caldwell","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Kishwaukee","city":"DeKalb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Delnor","city":"Geneva","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Glenview Outpatient Center","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Grayslake Outpatient Center","city":"Grayslake","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Lake Forest Hospital","city":"Lake Forest","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Warrenville","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Ankeny Clinic","city":"Ankeny","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Anthony Regional Hospital","city":"Carroll","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - West Des Moines Clinic","city":"Clive","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heartland Oncology and Hematology LLP","city":"Council Bluffs","state":"Iowa","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Methodist Jennie Edmundson Hospital","city":"Council Bluffs","state":"Iowa","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists/Oncology Hematology West PC - MEJ","city":"Council Bluffs","state":"Iowa","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Iowa Methodist Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Des Moines Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broadlawns Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center - Des Moines","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Laurel Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Healthcare Mission Cancer and Blood - Fort Dodge","city":"Fort Dodge","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Waukee Clinic","city":"Waukee","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital South","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Saint Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Hospital of Anaconda","city":"Anaconda","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic Cancer Center","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bozeman Health Deaconess Hospital","city":"Bozeman","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Benefis Sletten Cancer Institute","city":"Great Falls","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Logan Health Medical Center","city":"Kalispell","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Medical Center","city":"Missoula","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists/Oncology Hematology West PC - MECC","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Methodist Hospital","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates PC","city":"Omaha","state":"Nebraska","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Basking Ridge","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Commack","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-UC Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-West Chester","city":"West Chester","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Cancer Specialists and Research Institute-Tulsa","city":"Tulsa","state":"Oklahoma","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Ontario","city":"Ontario","state":"Oregon","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Providence Portland Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Vincent Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center-First Hill","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth D N Greenwald Center","city":"Mukwonago","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Oconomowoc Memorial Hospital","city":"Oconomowoc","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Waukesha Memorial Hospital","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UW Cancer Center at ProHealth Care","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network-Princess Margaret Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chinese University of Hong Kong-Prince of Wales Hospital","city":"Shatin","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"National University Hospital Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["nivolumab"],"locationSlugs":["dublin-california","fremont-california","fresno-california","los-angeles-california","modesto-california","newport-beach-california","oakland-california","palo-alto-california","roseville-california","sacramento-california","san-francisco-california","san-jose-california","san-leandro-california","san-rafael-california","santa-clara-california","santa-rosa-california","south-san-francisco-california","vallejo-california","walnut-creek-california","atlanta-georgia","honolulu-hawaii","boise-idaho","caldwell-idaho","coeur-dalene-idaho","nampa-idaho","post-falls-idaho","sandpoint-idaho","chicago-illinois","danville-illinois","dekalb-illinois","effingham-illinois","geneva-illinois","glenview-illinois","grayslake-illinois","lake-forest-illinois","mattoon-illinois","orland-park-illinois","urbana-illinois","warrenville-illinois","ankeny-iowa","carroll-iowa","clive-iowa","council-bluffs-iowa","des-moines-iowa","fort-dodge-iowa","waukee-iowa","st-louis-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","kalispell-montana","missoula-montana","omaha-nebraska","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","cincinnati-ohio","west-chester-ohio","oklahoma-city-oklahoma","tulsa-oklahoma","ontario-oregon","portland-oregon","charleston-south-carolina","seattle-washington","mukwonago-wisconsin","oconomowoc-wisconsin","waukesha-wisconsin","melbourne-australia","toronto-canada","shatin-hong-kong","singapore-singapore"],"enrichment":{"headline":"Phase 2: testing Carboplatin for Metastatic Nasopharyngeal Carcinoma","inPlainEnglish":"This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","PRIOR TO STEP 1 REGISTRATION:","Tumor showing (histological/cytological) Epstein-Barr encoded ribonucleic acid (EBER)-positivity (e.g., In situ hybridization, immunohistochemistry) or","A known history of detectable plasma EBV DNA (via a polymerase chain reaction \\[PCR\\]-based assay) at any time point since the initial diagnosis of NPC","Measurable disease as defined by RECIST 1.1 criteria. Lesion(s) that have been irradiated previously can be counted as measurable as long as radiological progression after the prior radiation therapy has been demonstrated","Contrast enhanced CT scan of the chest. The contrast enhanced CT component of a whole-body PET-CT is also acceptable. The plain (non-contrast) CT component of a PET-CT is not acceptable","CT the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated)","Patients with known locoregional disease must have contrast enhanced MRI or CT of the nasopharynx and neck as this disease site(s) may be assessed as target lesions. For patients without known locoregional disease, imaging of the nasopharynx and neck is optional"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Scan, or Carboplatin. The registry lists allocation as randomized. This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 156 people at 95 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.020Z"},{"nctId":"NCT06031233","title":"Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapie","officialTitle":"Evaluating the Safety of Shortened Infusion Times for dIfferent Oncological Immunotherapies; An Observational Prospective Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Isala","sponsorClass":"OTHER","summary":"This study is an interventional, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.\n\nInfusion times will be gradually shortened if tolerability allowes.","conditions":["Oncology","Infusion Reaction"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Ipilimumab"},{"type":"DRUG","name":"Durvalumab"},{"type":"DRUG","name":"Atezolizumab"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Trastuzumab"},{"type":"DRUG","name":"Rituximab"},{"type":"DRUG","name":"Infliximab"},{"type":"DRUG","name":"Vedolizumab"},{"type":"DRUG","name":"Tociliuzumab"}],"enrollment":1082,"startDate":"2023-09-01","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab.\n* 18 years and older.\n* No known history of increased susceptibility to immunological reactions.\n* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.\n\nExclusion Criteria:\n\n* Other research medication within 4 weeks of the start of the study.\n* Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions\n* Dosage deviates from standard protocol\n* Patients whom receive drugs through a central venous catheter (and for example porth-a-cath).","locations":[{"facility":"Isala Hospital","city":"Zwolle","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elianne CS de Boer","phone":"+31886245000","email":"polioncologie@isala.nl"}],"primaryOutcomes":["Incidence of infusion related reactions"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["pembrolizumab","nivolumab"],"locationSlugs":["zwolle-netherlands"],"enrichment":{"headline":"Phase 4: testing Nivolumab for Oncology","inPlainEnglish":"This study is an treatment, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile. Infusion times will be gradually shortened if tolerability allowes.","whoItsFor":["Ages 18 Years to any","Starting treatment with monoclonal antibodies: nivolumab, pembrolizumab ipilimumab, bevacizumab, trastuzumab, durvalumab or atezolizumab","18 years and older","No known history of increased susceptibility to immunological reactions"],"whoShouldSkip":["Other research medication within 4 weeks of the start of the study","Inclusion in medical research in which the administration of medication should follow its stated times and dosages of infusions","Dosage deviates from standard protocol","Patients whom receive drugs through a central venous catheter (and for example porth-a-cath)"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab, Pembrolizumab, or Ipilimumab. The registry lists allocation as randomized. This study is an treatment, explorative, prospective study to show whether shortening of infusion times for patients using nivolumab, pembrolizumab, ipilimumab, trastuzumab, bevacizumab, durvalumab or atezolizumab continues to be associated with an acceptable safety profile.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,082 people at Zwolle. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.017Z"},{"nctId":"NCT06045351","title":"Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome","officialTitle":"Efficacy of Vitamin D Supplementation in Females With Polycystic Ovary Syndrome: a Randomized Open Label Delayed-start Design","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"Aga Khan University","sponsorClass":"OTHER","summary":"Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by \"the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound\". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan. Researchers hypothesized that its correction would improve response to standard PCOS treatment. The objective is to compare PCOS parameters in intervention group (Group A) receiving VD supplementation and then PCOS care with control group (Group B) receiving standard PCOS care and then VD supplementation. A randomized open label trial: delayed-start design will be conducted on VD deficient PCOS females VD \\< 20ng/ml ; Group A will receive VD injections 600,000 I.U I/M once with 1 gram calcium supplement daily in the initial 12 weeks. After that standard PCOS care; i) Glucophage XR 750 mg (once for 15 days then twice daily) ii) progesterone supplementation (1 capsule Progeffik 100 mg every 3 weeks, then 1 week off) and iii) calcium supplements will be given for next 12 weeks. PCOS females in Group B will receive standard PCOS care (same) with addition of VD and calcium supplementation after 12 weeks till study end point. Study outcomes will be comparison of i) hyperandrogenism by Free Androgen Index \\[Total Testosterone, Steroid Hormone Binding Globulin ii) insulin Resistance by HOMA-IR (serum Insulin, Fasting Blood Glucose) and iii) oxidative stress by Total Antioxidant Capacity after 24-weeks in these Groups'd levels after supplementation will be assessed for confirmation of correction and calcium and albumin levels for detection of hypercalcemia. Results of this study will inform the clinicians to add VD before or after the standard PCOS care for rectification of endocrine and metabolic derangements as a cost-effective treatment and prevention strategy in these females.","conditions":["Anovulatory Infertility"],"keywords":["Poly cystic Ovarian Syndrome","randomized open label trial; delayed-start design","vitamin D","Pakistan"],"interventions":[{"type":"DRUG","name":"Vitamin D"},{"type":"OTHER","name":"Active Comparator"}],"enrollment":142,"startDate":"2024-01-01","completionDate":"2026-12-30","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Recently diagnosed PCOS with presence of at least 2 of these 3 elements: clinical or biochemical signs of hyperandrogenism, chronic anovulation and polycystic ovaries (1) (from reports of available routine TVS), with VDD serum levels VD \\<20 ng/ml(10), age range 18- 45 years, from all ethnic background will be included.\n\nExclusion Criteria:\n\n* : Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female subjects meeting any of the following criteria will be excluded from the study\n\n  * Pregnancy\n  * Hypercalcemia (plasma calcium concentrations\\> 2.65 mmol/L)\n  * Tuberculosis or other granulomatous disorders\n  * Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic\n  * Kidney disease or serum creatinine \\>2.0 mg/dL,\n  * Drug Therapies: VD replacement ; participants who had received VD injection in the last 3 months prior to recruitment in the study, oral contraceptives, hormonal replacement therapy, glucocorticoids, calcium supplementation, insulin-sensitizing drugs (incretin mimetic drugs, thiazolidinedione, sulfonylurea), lipid-lowering drugs or other drugs affecting insulin sensitivity or serum androgens (e.g., niacin, corticosteroids, beta-blockers, calcium channel blockers, thiazide diuretics), anti-epileptics, anti-retroviral, cholestyramine, anti-fungal, statins, H2 blockers, immunosuppressant, chemotherapeutic agents, antimicrobials (Rifampicin, Isoniazid, Hydroxychloroquine) or any other drug modifying lipid metabolism in the previous 3 months prior to study\n  * Suffering from congenital adrenal hyperplasia, Cushing's syndrome, androgen-secreting tumors, type 2 Diabetes Mellitus, renal, hepatic or thyroid disorders, hyperparathyroidism, malabsorption syndromes, Chronic Kidney Disease, Hepatic failure, cystic fibrosis, vaginal bleeding of unknown etiology or /and suffering from COVID-19 (within 3 months).","locations":[{"facility":"Aga Khan University Hospital","city":"Karachi","state":"Sindh","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rehana Rehman, PhD","phone":"00922134864460","email":"drrehana7@gmail.com"}],"primaryOutcomes":["hyperandrogenism","insulin Resistance","oxidative stress"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["karachi-pakistan"],"enrichment":{"headline":"Phase 1: testing Vitamin D for Anovulatory Infertility","inPlainEnglish":"Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by \"the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound\". Considering role of vitamin D (VD) (3, 4) and high prevalence (58%) of deficiency in PCOS of Pakistan.","whoItsFor":["Ages 18 Years to 45 Years","Women only"],"whoShouldSkip":[": Exclusion of subjects will be done by the Co-Principal Investigators (Co-PI) after history, examination and complete evaluation in the respective clinics. All female subjects meeting any of the following criteria will be excluded from the study","Hypercalcemia (plasma calcium concentrations\\> 2.65 mmol/L)","Tuberculosis or other granulomatous disorders","Chronic liver disease or alanine transaminase (ALT) level 3 times higher than the normal limit, chronic","Kidney disease or serum creatinine \\>2.0 mg/dL,"],"whatHappens":"If you join, the listed intervention(s) are Vitamin D, or Active Comparator. The registry lists allocation as randomized. Poly cystic Ovarian Syndrome (PCOS) is an endocrine disorder of reproductive age defined by \"the presence of any two out of three criteria: oligo and/or anovulation, excess androgen activity and/or polycystic ovarian morphology on ultrasound\".","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 142 people at Karachi. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.785Z"},{"nctId":"NCT06047626","title":"Living Well With Lymphoma","officialTitle":"Living Well With Lymphoma: Improving Diet Quality to Improve Energy, Sleep and Quality of Life","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Michigan Rogel Cancer Center","sponsorClass":"OTHER","summary":"In this study the investigators are proposing to evaluate the efficacy, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \\~10% drop out rate to achieve a target of 60 patients that will complete the study. The investigators hypothesize that persistently fatigued lymphoma cancer survivors will experience improvements in fatigue, quality of life, and symptoms commonly associated with fatigue, which are then maintained at 15-months post-enrollment; and decreased CRP and alterations in inflammation-associated DNA methylation consistent with reduced inflammation from following the FRD as compared to the GHC.","conditions":["Lymphoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Fatigue Reduction Diet"},{"type":"OTHER","name":"General Health Curriculum"}],"enrollment":100,"startDate":"2024-03-07","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women and men aged 18 years and older\n* Diagnosis of lymphoma (Hodgkin and non-Hodgkin)\n* Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory\n* Fatigue must be attributed to lymphoma diagnosis\n* Fatigue onset must be between 12months before diagnosis and any time after diagnosis\n* Fatigue must not be attributed to other disease diagnoses\n* Fruit and vegetable intake ≤5.5 servings/day\n* Have, or be willing to create, an email address to receive study questionnaires electronically.\n\nExclusion Criteria:\n\n* Medically unstable\n* BMI\\<18.5 kg/m2\n* Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder\n* Have a current untreated diagnosis of anemia\n* Have a current untreated diagnosis of hypothyroidism\n* Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study\n* Have a current diagnoses of cachexia\n* Planning on becoming pregnant, currently pregnant or lactating","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sara Snyder","phone":"734-998-7124","email":"fammed-szickstudy@med.umich.edu"}],"primaryOutcomes":["Brief Fatigue Inventory"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Fatigue Reduction Diet for Lymphoma","inPlainEnglish":"In this study the investigators are proposing to measure the how well it works, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC). The investigators will randomize and follow 68 lymphoma cancer survivors; accounting for a \\~10% drop out rate to achieve a target of 60 patients that will complete the study.","whoItsFor":["Ages 18 Years to any","Women and men aged 18 years and older","Diagnosis of lymphoma (Hodgkin and non-Hodgkin)","Have an average persistent fatigue defined as ≥ 4 on the Brief Fatigue Inventory","Fatigue must be attributed to lymphoma diagnosis","Fatigue onset must be between 12months before diagnosis and any time after diagnosis","Fatigue must not be attributed to other disease diagnoses","Fruit and vegetable intake ≤5.5 servings/day"],"whoShouldSkip":["Have a current untreated diagnosis of mood disorder, e.g., bipolar or major depressive disorder","Have a current untreated diagnosis of anemia","Have a current untreated diagnosis of hypothyroidism","Have an initiation, a cessation or change of treatment of any chronic medications, dietary supplements, behavioral therapy, physical therapy etc., or any planned change of medications, supplements, or therapies during the study","Have a current diagnoses of cachexia","Planning on becoming pregnant, currently pregnant or lactating"],"whatHappens":"If you join, the listed intervention(s) are Fatigue Reduction Diet, or General Health Curriculum. The registry lists allocation as randomized. In this study the investigators are proposing to measure the how well it works, sustainability, and mechanisms of 3 months of individualized counseling of the FRD delivered by registered dietitians, over 8 sessions by phone/video conferencing on fatigue, quality of life, and associated symptoms in persistently fatigued lymphoma cancer survivors compared to 3 months of individualized counseling of the attention control (matched for time and frequency of interactions with the FRD) the General Health Curriculum (GHC).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Ann Arbor. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.160Z"},{"nctId":"NCT06047782","title":"Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.","officialTitle":"Impact of Atrial Fibrosis Surface Area on the Occurrence of Atrial Fibrillation in Patients With Ischemic Stroke of Undetermined Origin: a Prospective Cardiac MRI Pilot Study.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Centre Hospitalier Universitaire Dijon","sponsorClass":"OTHER","summary":"Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure. Atrial fibrillation is a major cause of stroke, accounting for more than 25% of all strokes. In addition, a quarter of ischemic strokes remain without an obvious cause at the end of hospitalization, and it is recommended that atrial fibrillation be detected intensively with long-term heart rhythm recording. Implantable loop recorders can detect 30% of atrial fibrillation cases over the 3-year battery life of these devices, after a stroke of undetermined origin. However, these devices require a small operation to implant them under the skin, and they are expensive.\n\nThe hypothesis of this study is that MRI imaging of the left atrium would enable better selection of patients to receive an implantable loop recorder. MRI can quantify the proportion of the left atrium with scar tissue, which is likely to favour the onset of atrial fibrillation. If the results confirm this hypothesis, the number of patients requiring an implantable loop recorder could be reduced, and perhaps an anticoagulation strategy based on MRI data could be introduced.\n\nIn addition to the usual follow-up by cardiologists and neurologists, participation in this study involves a cardiac MRI (with contrast agent) within 3 months of the stroke.","conditions":["Stroke","Implantation of an Implantable Cardiac Monitor"],"keywords":[],"interventions":[{"type":"OTHER","name":"Cardiac MRI (with contrast agent)"}],"enrollment":157,"startDate":"2024-01-31","completionDate":"2031-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient who has provided free, written and informed consent\n* Patient of legal age\n* Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)\n* Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:\n\n  * cryptogenic ischemic stroke or stroke with probable cardioembolic cause\n  * no history of atrial fibrillation\n  * no long-term anticoagulant therapy\n  * with life expectancy \\>12 months\n\nExclusion Criteria:\n\n* Person not affiliated to national health insurance\n* Person under legal protection (curatorship, guardianship)\n* Person under court order\n* Pregnant, parturient or breast-feeding\n* Adult unable to give consent\n* Patient diagnosed with AF during stroke assessment\n* Patient with a contraindication to MRI or gadolinium injection:\n\n  * Severe renal impairment (\\<30ml/min Cockroft clearance due to gadolinium injection)\n  * Claustrophobia / contraindication to MRI (metal implant not MRI compatible)\n  * History of hypersensitivity to gadoteric acid or gadolinium-based contrast agents, and to meglumine\n  * Uncontrolled asthma","locations":[{"facility":"Chu Dijon Bourgogne","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Charles GUENANCIA","phone":"0380295623","email":"charles.guenancia@chu-dijon.fr"}],"primaryOutcomes":["Episode of atrial fibrillation (AF) lasting more than 30 seconds on the implantable loop recorder"],"hasResults":false,"conditionSlugs":["als","stroke","heart-failure","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["dijon-france"],"enrichment":{"headline":"Not a traditional drug phase: Cardiac MRI (with contrast agent) for Stroke","inPlainEnglish":"Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction. This increases the risk of stroke through clot formation in the atrium, but also of heart failure.","whoItsFor":["Ages 18 Years to any","Patient of legal age","Patient with cryptogenic ischemic stroke within 30 days of inclusion, documented by brain imaging (cerebral angioscan or cerebral MRI)","Patients scheduled for implantable loop recorder implantation within 3 months of ischemic stroke in search of silent AF:","cryptogenic ischemic stroke or stroke with probable cardioembolic cause","no history of atrial fibrillation","no long-term anticoagulant therapy","with life expectancy \\>12 months"],"whoShouldSkip":["Person not affiliated to national health insurance","Person under legal protection (curatorship, guardianship)","Person under court order","Pregnant, parturient or breast-feeding","Patient diagnosed with AF during stroke assessment","Patient with a contraindication to MRI or gadolinium injection:","Severe renal impairment (\\<30ml/min Cockroft clearance due to gadolinium injection)"],"whatHappens":"If you join, the listed intervention(s) are Cardiac MRI (with contrast agent). The registry lists allocation as na. Atrial fibrillation is a cardiac arrhythmia most often originating in the left atrium, causing anarchic electrical activity and thus a loss of atrial contraction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 157 people at Dijon. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.750Z"},{"nctId":"NCT06054035","title":"SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes","officialTitle":"SGLT2 Inhibition in Addition to Lifestyle Intervention and Risk for Complications in Subtypes of Patients With Prediabetes - a Randomized, Placebo Controlled, Multi-center Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University Hospital Tuebingen","sponsorClass":"OTHER","summary":"More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease. Thus, it is of utmost importance to improve prevention of T2D and with this complications. Remission of prediabetes, i.e. normalization of hyperglycemia by means of lifestyle intervention is one of the most effective ways to prevent the development of T2D and complications. Novel sub-phenotyping analysis identified clusters of risk for diabetes associated with different complications, opening opportunities to new therapeutic approaches, despite and in addition to lifestyle changes. So far, pharmacological therapy is not indicated for patients with prediabetes. Remission of hyperglycemia associated with prediabetes during lifestyle interventions not only prevents T2D but is also linked with reduced albuminuria and lower microvascular and kidney complications. Thus, reaching normoglycemia (i.e. prediabetes remission) is important for reducing the risk of (pre-)diabetes-associated complications including micro- and even macrovascular disease. In patients with T2D, recent data show that dapagliflozin can improve diabetes remission, and thus, likely complications. However, to date no data have assessed whether or not this is also true in patients with hyperglycemia related to prediabetes which, as outlined above, already causes different complications.\n\nSubphenotyping of patients with newly onset diabetes suggests that for some individuals, it would be too late to start interventions against dagainst complications at the time of diagnosis of type 2 diabetes. Therefore, individuals at elevated risk to develop T2D and complications should receive preventive measures well before the diagnosis of T2D. This study will provide evidence whether such an early intervention contributes to the remission of hyperglycemia related to prediabetes to protect from associated complications such as renal disease. The studied population will comprise individuals who have hyperglycemia in the range of prediabetes and are thus prone to not only develop T2D, but also early nephropathy but in clinical practice do not receive medical treatment due to the early stage of the disease. These subjects will receive Dapagliflozin 10 mg or Placebo for 6 months. The placebo treatment arm reflects current practice. In order guarantee a benefit the patients in the placebo arm will receive a lifestyle intervention.","conditions":["Type2diabetes","PreDiabetes","Renal Failure"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dapagliflozin (Forxiga®)"},{"type":"DRUG","name":"Placebo matching Dapaglifolzin"},{"type":"BEHAVIORAL","name":"Lifestyle Intervention"}],"enrollment":170,"startDate":"2023-10-26","completionDate":"2027-06-30","sex":"ALL","minAge":"35 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Male, female or intersexualpatients aged between 35 and 75 years (including)\n2. Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140 mg/dL)\n3. BMI ≥20 kg/m2\n4. TSH within normal range\n5. Ability to understand and follow study-related instructions\n6. Negative pregnancy test for premenopausal women (blood)\n7. Patients who are receiving thyroid replacement therapy must be on a stable treatment regimen for at least 3 months prior to the screening visit (V-1)\n8. Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen for at least 6 weeks prior to the screening visit (V-1)\n9. Patients who are treated antihypertensive medication such as ACE inhibitors and AT1receptor antagonists, thiazides as well as loop diuretics must be on stable treatment for at least 2 weeks\n10. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.\n11. Patients will not be included in the study if, in the opinion of the investigator participation will lead to an unacceptable risk to the subjects' safety or well-being\n\nExclusion Criteria\n\n1. Manifest diabetes mellitus\n2. eGFR (as calculated by the CKD-EPI equation) \\< 60 ml/min/1.73 m2\n3. all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)\n4. Symptomatic chronic congestive heart disease\n5. New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks\n6. known or suspected orthostatic proteinuria\n7. any acute severe or chronic severe illness, including the following: malignant disease ongoing or \\< 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure\n8. history of or current therapy for congestive heart failure (NYHA III and IV), pacemaker or aortic stenosis \\> II°\n9. acute pancreatic disease (i.e. elevated lipase 3x ULN)\n10. rapidly progressing renal disease or anuria\n11. known HIV infection or positive HIV test at screening\n12. history of or planned organ transplantation\n13. history or presence of inflammatory bowel disease or other severe gastrointestinal diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis\n14. relevant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase and/or aspartate aminotransferase \\> 3 x upper limit of normal and/or total bilirubin (TB) \\> 2 mg/dL (\\> 34.2 μmol/L) (patients with TB \\> 2 mg/dL \\[\\> 34.2 μmol/L\\] and documented Gilbert's syndrome will be allowed to participate).\n15. treatment with glucocorticoids\n16. antibiotic treatment within the last 4 weeks\n17. History of ketoacidosis\n18. history of repeated urogenital infection\n19. hemoglobinopathies, haemolytic anaemia, or chronic anaemia (haemoglobin concentration \\<12.0 g/dL)\n20. presence of psychiatric disorder or new intake of antidepressant or antipsychotic agents(start within last 3 months)\n21. Positive Screening for a severe depression (BDI ≥29)\n22. history of hypersensitivity to the study drug or its ingredients\n23. more than 5% weight loss in the last 3 months\n24. Pregnant or breastfeeding women\n25. Subject (male, female or intersexual) is not willing to use highly effective contraceptive methods during treatment and for 14 days (male or female) after the end of treatment (highly effective methods are defined as: combined hormonal contraception associated with inhibition of ovulation, progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence).\n\n    Vasectomized partner is a highly effective birth control method provided that partner is the sole sexual partner of the trial participant and that the vasectomized partner has received medical assessment of the surgical success.\n26. Current participation in other interventional clinical trials or treatment with other IMPs within five times the half-life of the drug\n27. Previous therapy with dapagliflozin or other drugs that can potentially lead to overlapping toxicities within five times the half-life of the drug\n28. Patients who do not want to be informed about accidental findings\n29. Any other clinical condition that would jeopardize subjects' safety or well-being while participating in this clinical trial\n30. Patients will not be included in the study if, in the opinion of the investigator, participation leads to an unacceptable risk to their safety and well-being","locations":[{"facility":"Charité Universitätsmedizin Berlin, Klinik für Endokrinologie und Stoffwechselmedizin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsstudienzentrum für Stoffwechselerkrankungen , Medizinische Klinik und Poliklinik III","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf","city":"Düsseldorf","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heidelberg University Hospital - Department of Endocrinology and Metabolism","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Klinik und Poliklinik III - Bereich Endokrinologie","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Klinik I, UKSH Campus LübeckAG Meyhöfer - Endocrinology, Diabetes & Metabolism","city":"Lübeck","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diabetes Center Med. Klinik und Poliklinik IV, Klinikum der Universität München, LMU","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut für Ernährungsmedizin, Technische Universität München","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Tuebingen, Otfried-Mueller Str. 10","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andreas Birkenfeld, Prof. Dr.","phone":"0049707129","email":"andreas.birkenfeld@med.uni-tuebingen.de"},{"name":"Andreas Fritsche, Prof. Dr.","phone":"0049707129","email":"andreas.fritsche@med.uni-tuebingen.de"}],"primaryOutcomes":["Frequency of remission of hyperglycemia"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":["dapagliflozin"],"locationSlugs":["berlin-germany","dresden-germany","d-sseldorf-germany","heidelberg-germany","leipzig-germany","l-beck-germany","m-nchen-germany","t-bingen-germany"],"enrichment":{"headline":"Phase 4: testing Dapagliflozin (Forxiga®) for Type2diabetes","inPlainEnglish":"More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease. Additionally, many patients at risk for diabetes develop metabolically driven complications including kidney and heart disease.","whoItsFor":["Ages 35 Years to 75 Years","Male, female or intersexualpatients aged between 35 and 75 years (including)","Prediabetes (defined by one of the following: FG ≥ 100 mg/dL or 2h OGTT glucose ≥ 140 mg/dL)","TSH within normal range","Ability to understand and follow study-related instructions","Negative pregnancy test for premenopausal women (blood)","Patients who are receiving thyroid replacement therapy must be on a stable treatment regimen for at least 3 months prior to the screening visit (V-1)","Patients who are receiving antihypertensive medication such as mineralocorticoid receptor antagonists must be on a stable treatment regimen for at least 6 weeks prior to the screening visit (V-1)"],"whoShouldSkip":["Manifest diabetes mellitus","eGFR (as calculated by the CKD-EPI equation) \\< 60 ml/min/1.73 m2","all glucose altering medications (including current therapy with dapagliflozin or empagliflozin or any other SGLT2-Inhibitor)","Symptomatic chronic congestive heart disease","New diuretic or antihypertensive medication or dosing changes within the last 2 weeks, for aldosterone antagonists within the last 6 weeks","known or suspected orthostatic proteinuria","any acute severe or chronic severe illness, including the following: malignant disease ongoing or \\< 5 years ago, unstable cardiovascular disease or procedure within 3 months prior to enrolment or expected to require coronary revascularisation procedure"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin (Forxiga®), Placebo matching Dapaglifolzin, or Lifestyle Intervention. The registry lists allocation as randomized. More than 50% of patients with type 2 diabetes develop micro- and/or macrovascular complications during the course of the disease.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 170 people at 9 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.975Z"},{"nctId":"NCT06054906","title":"Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) for Resectable Locally Advanced Gastric Cancer","officialTitle":"Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) for Resectable Locally Advanced Gastric Cancer : A Phase Il Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Huashan Hospital","sponsorClass":"OTHER","summary":"To evaluate efficacy and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) in resectable locally advanced gastric cancer.","conditions":["Gastric Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"sintilimab+metronomic POLF"}],"enrollment":50,"startDate":"2023-10-18","completionDate":"2026-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed written Informed Consent Form\n2. Male or female, age ≥ 18 years old\n3. Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator\n4. No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand\n5. Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon\n6. ECOG PS: 0-1 score\n7. Expected survival \\> 6 months\n8. Adequate organ function, must meet the following laboratory specifications:\n\n   8.1 Absolute neutrophil count (ANC) ≥ 1.0x10\\^9/L; 8.2 Platelets ≥ 80x10\\^9/L; 8.3 Hemoglobin \\> 7g/dL; 8.4 Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (Total bilirubin \\> 1.5 x ULN but direct bilirubin ≤ ULN are allowed to be enrolled); 8.5 AST, ALT ≤ 2.5×ULN; 8.6 Blood creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 ml/min; 8.7 INR or PT ≤ 1.5 times ULN; 8.8 TSH within normal range (Enrollment allowed if baseline TSH is outside normal range but FT4 is within normal range); 8.9 Myocardial enzyme profile within normal range;\n9. Negative pregnancy test in women of childbearing age\n10. Need to use contraception with an annual failure rate of less than 1% if there is a risk of conception\n\nExclusion Criteria:\n\n1. Endoscopically show signs of active bleeding from the lesion\n2. Current participation in an interventional clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug\n3. Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc.\n4. Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy\n5. Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug\n6. Live vaccination within 30 days prior to the first administration of the drug\n7. Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug\n8. Have received systemic glucocorticoid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment\n9. Has not fully recovered from any intervention-induced toxicity and/or complications (excluding malaise or alopecia) prior to initiation of therapy\n10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation\n11. Known hypersensitivity to drugs used in this study\n12. Known history of HIV infection\n13. Untreated active hepatitis B\n14. Active HCV infection\n15. Pregnant or lactating women\n16. The presence of any serious or uncontrolled systemic disease\n17. Other factors that, in the judgment of the investigator, may affect the outcome of the study","locations":[{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Percentage of participants with no residual surviving tumor cells in resection specimens and lymph nodes","Percentage of participants with ≤10% tumor cell survival in resection specimens"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing sintilimab+metronomic POLF for Gastric Cancer","inPlainEnglish":"To evaluate how well it works and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) in resectable locally advanced gastric cancer.","whoItsFor":["Ages 18 Years to any","Male or female, age ≥ 18 years old","Histologically confirmed gastric adenocarcinoma, diagnosed as locally progressive according to the AJCC 8th ed, cTNM diagnosis of cT3-4aN1-3M0 and resectable lesion as assessed by the investigator","No prior systemic therapy such as surgery, radiotherapy, or immunotherapy for the disease at hand","Consent to radical surgical treatment and no contraindications to surgery as determined by the surgeon","Expected survival \\> 6 months","Adequate organ function, must meet the following laboratory specifications:","Negative pregnancy test in women of childbearing age"],"whoShouldSkip":["Endoscopically show signs of active bleeding from the lesion","Current participation in an treatment clinical study or treatment with another investigational drug or use of an investigational device within 4 weeks prior to the first dose of study drug","Prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or agents targeting CTLA-4, OX-40, CD137, etc","Diagnosis of a malignant disease other than gastric cancer within 5 years prior to the first dose of therapy","Active autoimmune disease requiring systemic therapy within 2 years prior to the first dose of the drug","Live vaccination within 30 days prior to the first administration of the drug","Have received systemic systemic therapy with proprietary Chinese medicines with antitumor indications or immunomodulatory drugs within 2 weeks prior to the first administration of the drug"],"whatHappens":"If you join, the listed intervention(s) are sintilimab+metronomic POLF. The registry lists allocation as na. To evaluate how well it works and safety of Neoadjuvant of Sintilimab Combined Weekly Metronomic Chemotherapy (POLF) in resectable locally advanced gastric cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.965Z"},{"nctId":"NCT06058377","title":"Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer","officialTitle":"Phase III Trial of Neoadjuvant Durvalumab (NSC 778709) Plus Chemotherapy Versus Chemotherapy Alone for Adults With MammaPrint High 2 Risk (MP2) Hormone Receptor (HR) Positive / Human Epidermal Growth Factor Receptor (HER2) Negative Stage II-III Breast Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as paclitaxel, doxorubicin, and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. There is some evidence from previous clinical trials that people who have a MammaPrint High 2 Risk result may be more likely to respond to chemotherapy and immunotherapy. Adding durvalumab to usual chemotherapy may be able to prevent the cancer from returning for patients with MP2 stage II-III hormone receptor positive, HER2 negative breast cancer.","conditions":["Anatomic Stage II Breast Cancer AJCC v8","Anatomic Stage III Breast Cancer AJCC v8","HER2-Negative Breast Carcinoma","Hormone Receptor-Positive Breast Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Doxorubicin"},{"type":"BIOLOGICAL","name":"Durvalumab"},{"type":"OTHER","name":"Genetic Testing"},{"type":"PROCEDURE","name":"Mammography"},{"type":"DRUG","name":"Paclitaxel"},{"type":"OTHER","name":"Quality-of-Life Assessment"}],"enrollment":3680,"startDate":"2023-11-27","completionDate":"2032-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1: REGISTRATION (SCREENING): Participants must have histologically confirmed estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (hormone receptor positive) and HER2 negative breast cancer, as per American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines\n\n  * NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible\n* STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer\n\n  * NOTE: Participants with inflammatory breast cancer are eligible\n  * NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node\n* STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines\n* STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer\n* STEP 1: REGISTRATION (SCREENING): Participants with multifocal disease in the same breast or synchronous bilateral primary tumors are eligible, however, all tumors that are biopsied must be hormone receptor positive and HER2 negative per ASCO CAP guidelines and at least one of the tumors must be MammaPrint High-2. MammaPrint can be performed sequentially on biopsies as it is sufficient to have MammaPrint High 2 status on at least one of the lesions\n\n  * NOTE: Biopsy of multiple lesions in the same breast is not required if the clinical presentation is consistent with a single disease process that is multifocal in nature. However, if there is clinical suspicion of two distinct primary breast malignancies, additional biopsies should be pursued\n* STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status\n\n  * Submitting tissue for on-study MammaPrint testing:\n\n    * Participants must have a minimum of ten, unstained formalin-fixed paraffin-embedded (FFPE) slides (4-5 micron thickness) available from initial tumor biopsy for MammaPrint assessment\n\n      * NOTE: Participants must agree to have this tissue submitted to Agendia for MammaPrint Index Scoring and to have subsequent results disclosed to Southwest Oncology Group (SWOG) Cancer Research Network OR\n  * Submitting prior known MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants must agree to have their commercial MammaPrint Index Score disclosed to SWOG Cancer Research Network\n      * NOTE: Participants with prior known MammaPrint result that is not MP2 status should not be enrolled to either step of this study\n      * NOTE: Participants enrolling with known MP2 status (i.e. MP already obtained as routine care) must only sign the treatment informed consent form. Screening consent is not required when MP2 status is known prior to study enrollment\n* STEP 1: REGISTRATION (SCREENING): Participants must not have received any prior treatment for their current breast cancer, including chemotherapy, immunotherapy, biologic or hormonal therapy, and must be candidates for doxorubicin, paclitaxel, and durvalumab therapy\n* STEP 1: REGISTRATION (SCREENING): Participants must be \\>= 18 years old at the time of registration\n* STEP 1: REGISTRATION (SCREENING): Participants must have body weight \\> 30 kg\n* STEP 1: REGISTRATION (SCREENING): Participants must have Zubrod Performance Status of 0-2\n* STEP 1: REGISTRATION (SCREENING): Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 1: REGISTRATION (SCREENING): Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 1: REGISTRATION (SCREENING): NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* STEP 2: RANDOMIZATION: Participants must have met all eligibility criteria for Step 1 Registration\n* STEP 2: RANDOMIZATION: Participants must have MammaPrint High Risk 2 result\n\n  * For participants submitting tissue for on-study MammaPrint testing:\n\n    * Participants must be registered to Step 2: Randomization within 84 calendar days (12 weeks) after receiving an MP2 status from the MammaPrint Index score. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) from initial tumor biopsy OR\n  * Submitting commercial MammaPrint Index Score:\n\n    * If a MammaPrint Index Score report from within the last 12 weeks is already known and is MP2 status, the participant must be registered to Step 2 immediately following Step 1 registration provided they meet all other criteria. MP2 status is defined as a MammaPrint Index score between negative 1.0 and negative 0.57 (-1.0 to -0.57, including negative 1.0 and negative 0.57) tested from initial tumor biopsy\n\n      * NOTE: Participants without a MammaPrint High-Risk 2 score must not be registered to Step 2 Randomization\n* STEP 2: RANDOMIZATION: Participants must not have received live vaccines within 28 days prior to study Step 2: Randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines and coronavirus disease 2019 (COVID-19) vaccines are allowed; however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated vaccines, and are not allowed\n* STEP 2: RANDOMIZATION: Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* STEP 2: RANDOMIZATION: Participant must have Zubrod Performance Status of 0-2\n* STEP 2: RANDOMIZATION: Participants must not have a history of (non-infectious) pneumonitis that required steroids or evidence of active pneumonitis within two years prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must not have active autoimmune disease that has required systemic treatment in the past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs) prior to Step 2: Randomization. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* STEP 2: RANDOMIZATION: Participant must have a complete medical history and physical exam within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Leukocytes \\>= 3 x 10\\^3/uL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Absolute neutrophil count \\>= 1.5 x 10\\^3/uL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Platelets \\>= 100 x 10\\^3/uL (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Total bilirubin =\\< institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\\< 5 x institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\\< 3 × institutional ULN (within 28 days prior to Step 2: Randomization)\n* STEP 2: RANDOMIZATION: Participants must have a calculated creatinine clearance \\>= 50 mL/min using the Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better\n* STEP 2: RANDOMIZATION: Participants must not have uncontrolled diabetes defined as hemoglobin A1c of 9.0% or greater, within 28 days prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have an undetectable viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization\n* STEP 2: RANDOMIZATION: Participants with history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained while on suppressive therapy within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to Step 2: Randomization, if indicated\n* STEP 2: RANDOMIZATION: Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process and must have a negative pregnancy test at screening. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* STEP 2: RANDOMIZATION: Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the SWOG Specimen Tracking System\n* STEP 2: RANDOMIZATION: Participants who can complete questionnaires in English, or Spanish must be offered the opportunity to participate in the Quality of Life study\n* STEP 2: RANDOMIZATION: NOTE: As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* STEP 2: RANDOMIZATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-Orange Grove Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Auburn Faith Hospital","city":"Auburn","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIS Cancer Center at San Joaquin Community Hospital","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alta Bates Summit Medical Center-Herrick Campus","city":"Berkeley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Antelope Valley","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University Medical Center","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Long Beach Elm","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute - West Los Angeles Office","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Medical Center","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Newport Beach","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Desert Regional Medical Center","city":"Palm Springs","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation Health 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3: testing Cyclophosphamide for Anatomic Stage II Breast Cancer AJCC v8","inPlainEnglish":"This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","NOTE: Participants with HER2 positive disease by ASCO CAP guidelines are ineligible. HER2 negative and HER2 low or equivocal cases as per ASCO CAP guidelines that do not receive HER2 targeted therapy are eligible","STEP 1: REGISTRATION (SCREENING): Participants must have clinical stage II or III breast cancer","NOTE: Participants with inflammatory breast cancer are eligible","NOTE: Participants with occult (i.e. undetectable) primary breast cancer with axillary nodal involvement are not eligible, as MammaPrint testing has not been validated on tissue obtained from an axillary lymph node","STEP 1: REGISTRATION (SCREENING): Participants must not have metastatic disease (i.e., must be clinically M0 or Mx) Systemic staging studies with imaging should follow routine practice as per National Comprehensive Cancer Network (NCCN) and ASCO guidelines","STEP 1: REGISTRATION (SCREENING): Participants must not have locally recurrent breast cancer","STEP 1: REGISTRATION (SCREENING): Participants must have either adequate tissue available to submit on-study or a prior known MammaPrint Index Score that is MP2 status"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cyclophosphamide, or Doxorubicin. The registry lists allocation as randomized. This phase III trial compares the addition of an immunotherapy drug (durvalumab) to usual chemotherapy versus usual chemotherapy alone in treating patients with MammaPrint High 2 Risk (MP2) stage II-III hormone receptor positive, HER2 negative breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 3,680 people at 565 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.446Z"},{"nctId":"NCT06060613","title":"Safety and Efficacy of OBX-115 in Advanced Solid Tumors","officialTitle":"A Phase 1/2, Open-Label Study to Investigate the Safety and Efficacy of Membrane Bound IL15 Expressing Tumor-Infiltrating Lymphocytes (OBX-115) In Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Obsidian Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This is a study to investigate the safety and efficacy of an investigational OBX-115 regimen in adult participants with advanced solid tumors.","conditions":["Tumor Skin","Metastatic Melanoma","Melanoma","Lung Cancer","Metastatic Lung Cancer","Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer"],"keywords":["Adoptive cell therapy","Tumor Infiltrating Lymphocytes","TIL","Melanoma","Lung Cancer"],"interventions":[{"type":"BIOLOGICAL","name":"OBX-115"}],"enrollment":254,"startDate":"2023-10-25","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant must be 18 years of age or older at the time of signing the informed consent.\n2. Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC).\n3. Cohort and indication specific criteria as follows:\n\n   1. Phase 1 and Phase 2 Cohort 1 (enrollment complete):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the adjuvant PD-1/PD-L1 blocking antibody.\n   2. Phase 1 and Phase 2 Cohort 2 (recruiting):\n\n      * Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease).\n      * Participants who received PD-1/PD-L1 inhibitor-based therapy in the adjuvant or neoadjuvant setting and whose disease relapsed or progressed to metastatic disease within 6 months of their last systemic PD-1/PD-L1 treatment are eligible without requiring additional treatment in the metastatic setting.\n      * Participants who experienced disease progression following a prior cytotoxic chemotherapy-based regimen may have received no more than one additional chemotherapy-containing regimen. However, participants must not have had disease progression while receiving this second-chemotherapy containing regimen.\n   3. Phase 2 Cohort 3 (recruiting):\n\n      * Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody.\n      * Participants with melanoma must not exceed 2 prior lines of systemic therapy. Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy unless the participant progressed during or within the 12 weeks after the last dose of the (neo)adjuvant PD-1/PD-L1 blocking antibody.\n      * Participants with targetable BRAF mutations are not required to have received prior BRAF inhibitors. Participants must not have disease progression on a BRAF/MEK inhibitor that was given as the most recent line of therapy.\n   4. Phase 2 Cohort 4 (recruiting):\n\n      * Participants with frontline unresectable or metastatic melanoma.\n      * Participants may have received up to 2 doses of system therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody-based treatment of unresectable metastatic melanoma (but must not have known clinical progression prior to tumor procurement.) Neoadjuvant/Adjuvant treatment will not be considered a prior line of systemic therapy; however, participants whose disease progressed within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody given as (neo)adjuvant treatment (primary ICI resistant) are not eligible.\n4. Participant is assessed as having at least one lesion (or aggregate lesions) suitable for OBX-115 generation.\n5. After tumor tissue procurement, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.\n6. Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of greater than 6 months.\n7. Participant has recovered from all prior anticancer treatment-related AEs to at least Grade 1 (per Common Terminology Criteria for Adverse Events \\[CTCAE\\]).\n8. Participants must have completed post-operative recovery from any prior surgical procedures with wound healing and resolution of all surgical complications prior to planned tumor procurement surgery.\n9. Both male and female (women of childbearing potential) participants agree to the follow protocol specified contraceptive and/or abstinence requirements.\n10. Participant has protocol specified hematologic parameters for absolute neutrophil count (ANC) and platelet count.\n11. Participant has adequate cardiac, liver, lung, and kidney organ function as specified in the protocol.\n\nExclusion Criteria:\n\n1. Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ).\n2. Participant has a history of brain metastases or leptomeningeal disease. Participants may be considered for enrollment if they have 4 or fewer brain metastatic lesions that are that have been treated, if clinically indicated. Asymptomatic brain metastases that are equivocal or too small to warrant treatment may not be counted towards the above set limits upon discussion and agreement from the Medical Monitor.\n3. Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation.\n4. Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions.\n5. Participant has any form of primary or acquired immunodeficiency.\n6. Participant has a history of hypersensitivity to any component of the study intervention.\n7. Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions).\n8. Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed.\n9. Participant requires systemic steroid therapy of greater than10 mg/day of prednisone or equivalent.\n10. Participant received a live or attenuated vaccination within 28 days prior to the start of lymphodepletion (LD).\n11. Participant has evidence of positive infectious disease screening and/or any active uncontrolled viral, bacterial, or fungal disease requiring ongoing systemic treatment or identified during screening.","locations":[{"facility":"Banner Health","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute (Melanoma)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Comprehensive Cancer Center (Melanoma/NSCLC)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute (Melanoma/NSCLC)","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advent Health Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute (Melanoma/NSCLC)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Graham Brown Cancer Center (Melanoma/NSCLC)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering (Melanoma/NSCLC)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Allegheny Research Institute (Melanoma/NSCLC)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M.D. Anderson Cancer Center (Melanoma/NSCLC)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Melanoma Institute of Australia","city":"Wollstonecraft","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Obsidian Therapeutics","phone":"781-202-5423","email":"OBX115-2301TRIAL@OBSIDIANTX.COM"}],"primaryOutcomes":["Incidence and nature of dose-limiting toxicities (DLTs)","The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1","The proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["tucson-arizona","los-angeles-california","stanford-california","miami-florida","orlando-florida","tampa-florida","louisville-kentucky","new-york-new-york","columbus-ohio","pittsburgh-pennsylvania","houston-texas","wollstonecraft-australia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing OBX-115 for Tumor Skin","inPlainEnglish":"This is a study to investigate the safety and how well it works of an investigational OBX-115 regimen in adult participants with advanced solid tumors.","whoItsFor":["Ages 18 Years to any","Participant has a histologically confirmed diagnosis of advanced/metastatic melanoma or relapsed refractory metastatic non-small cell lung cancer (NSCLC)","Cohort and indication specific criteria as follows:","Phase 1 and Phase 2 Cohort 1 (enrollment complete):","Participants with unresectable or metastatic melanoma must have experienced documented radiographic disease progression after systemic therapy containing a programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) blocking antibody","Phase 1 and Phase 2 Cohort 2 (recruiting):","Participants with non-small cell lung cancer should have relapsed or are refractory to approved systemic therapies (approved ICI-based regimen for all appropriate participants and/or an approved targeted therapy for known molecular abnormalities if applicable to their disease)","Phase 2 Cohort 3 (recruiting):"],"whoShouldSkip":["Participant has melanoma of uveal origin or its other genetic equivalents (e.g. GNA11 and GNAQ)","Participant has an active medical illness(es) that, in the opinion of the Investigator, would pose increased risks for study participation","Participants with non-small cell lung cancer with refractory and clinically significant pleural effusions","Participant has any form of primary or acquired immunodeficiency","Participant has a history of hypersensitivity to any component of the study intervention","Participant had another primary malignancy within the previous 3 years (with protocol specified exceptions)","Participant has a history of allogeneic organ transplant, allogeneic cell therapy, or genetically engineered cell therapy. Prior engineered TIL cell therapy is allowed"],"whatHappens":"If you join, the listed intervention(s) are OBX-115. The registry lists allocation as na. This is a study to investigate the safety and how well it works of an investigational OBX-115 regimen in adult participants with advanced solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 254 people at 14 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.819Z"},{"nctId":"NCT06062498","title":"Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer","officialTitle":"Randomized Phase II Study of Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor (Palbociclib, Abemaciclib, or Ribociclib) in Patients With ER+/HER2- Advanced or Metastatic Breast Cancer With Prior Exposure to a CKD4/6 Inhibitor","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype. Endocrine therapy is the mainstay of treatment; however, due to the varied nature of the disease, development of resistance to this therapeutic approach is very common in the metastatic setting.\n\nThe purpose of this study is to see whether the effectiveness of elacestrant can be enhanced by combining it with a targeted agent such as a CDK4/6 inhibitor to treat patients with ER+/HER2- or metastatic breast cancer with prior exposure to a CDK4/6 inhibitor.","conditions":["Estrogen-receptor-positive Breast Cancer","HER2/Neu-Negative Breast Cancer","Advanced Breast Cancerv","Metastatic Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"elacestrant, palbociclib, abemaciclib, ribociclib"}],"enrollment":174,"startDate":"2023-09-29","completionDate":"2028-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria All Arms:\n\n* Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020, Wolff et al, 2018).\n\nNote: In the context of this trial, ER status will be considered positive if \\>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Note: Fresh biopsy is not a requirement.\n\n* Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done as standard of care; there is no research-related mutational testing for this study. ctDNA may be used for mutational testing.\n* Patients must have at least one measurable lesion (as per RECIST v1.1) lesion anywhere in the body or a mainly lytic metastatic bone lesion. Note: Lytic bone lesions with identifiable soft tissue components that can be evaluated by cross-sectional imaging techniques such as CT or MRI can be considered as measurable lesions if the soft tissue component meets the definition of measurability per RECIST v1.1.\n* Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting.\n* Patients must be age ≥ 18 years. Patients of childbearing potential (POCBP) may be premenopausal, postmenopausal, or perimenopausal.\n* Potential POCBP who may be menopausal and are \\< 55 years of age must have a serum follicle-stimulating hormone (FSH) level \\> 40 mIU/mL to confirm menopause.\n* Patients must exhibit an ECOG performance status of 0 or 1.\n* Patients must have adequate organ and bone marrow function as defined below:\n\nLeukocytes (WBC) ≥ 3,000/mcL Absolute neutrophil count (ANC) ≥ 1,500/mcL Hemoglobin (Hgb) ≥ 80-100 g/dL Platelets (PLT) ≥ 50,000/mcL Total serum bilirubin \\< 1.5 x Institutional upper limit of normal (ULN) AST (SGOT) ≤ 3 x institutional ULN (no liver metastases)\n\n* 5 x institutional ULN (liver metastases present) ALT (SGPT) ≤ 3 x institutional ULN\n* 5 x institutional ULN (liver metastases present) Cockcroft-Gault based creatinine clearance\n\n  * 50 mL/min\n\nNote:\n\n* Creatinine clearance (DMAB)\n\n  = (\\[140-age in years\\] × weight in kg)/ (\\[serum creatinine in mg/dL\\] × 72)\n* Creatinine clearance (DFAB) = (0.85 × \\[140-age in years\\] × weight in kg)/ (\\[serum creatinine in mg/dL\\] × 72) Note: Growth factor/transfusion support to attain these levels is not permitted.\n\n  * For patients with a known history of human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.\n  * For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n  * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are eligible.\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. Elacestrant is a known teratogen. For this reason, patients of child-bearing potential (POCBP) and their partners with sperm-producing reproductive capacity must agree to use adequate contraception (see Appendix B) from time of informed consent, for the duration of study participation, and for 7 days following completion of elacestrant therapy.\n\nShould a POCBP become pregnant or suspect they are pregnant while they or their partner are participating in this study, they should inform their treating physician immediately. Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must also agree to use adequate contraception with partners of childbearing potential from time of informed consent, for the duration of study participation, and 7 days after completion of administration. Note: A POCBP is any patient (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) with an egg-producing reproductive tract who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy\n* Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months) Note: POCBP who are on combination therapy with any study CKD4/6 inhibitor (palbociclib, abemaciclib, or ribociclib) must agree to use adequate contraception from time of informed consent, for the duration of study participation, and for 21 days following completion of CKD4/6 inhibitor therapy. POCBP must have a negative pregnancy test prior to registration on study. If initial urine pregnancy test is positive or cannot be confirmed negative, serum pregnancy test will be required. -Patients must have the ability to understand and the willingness to sign a written informed consent document.\n\nInclusion Criteria - Combination Therapy Arm 2 with Palbociclib, Abemaciclib, or Ribociclib\n\n-Patients who have been treated with one or two prior hormonal therapies in the metastatic setting if at least one hormonal therapy was in combination with a CDK4/6 inhibitor.\n\nNotes:\n\n* Patients who are already on or have already been exposed to one or two of the study CDK4/6 inhibitors at registration will be assigned a different study CDK4/6 inhibitor (e.g., if a patient has already been exposed to abemaciclib, they will be given ribociclib or palbociclib; similarly, if a patient has already been exposed to palbociclib and abemaciclib, they will be given ribociclib.)\n* One-to-one randomization will be done by the QA team once patients have been registered.\n\nExclusion Criteria All Arms:\n\n* Patients who have received prior elacestrant.\n* Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration.\n* Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment.\n* Patients with brain metastases. Note: Patients with stable brain or subdural metastases are allowed if the patient has completed local therapy and was on a stable or decreasing dose of corticosteroids at baseline for brain management for at least 4 weeks before starting treatment in this study. The dose must be \\<2.0 mg/day of dexamethasone or equivalent. Any signs (e.g., radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment. RANO criteria are used to evaluate brain metastases\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 3) with the exception of alopecia.\n* Patients who are receiving any other investigational agents. For patients who were previously on palbociclib, abemaciclib, or ribociclib, the washout period between stopping that CDK4/6 inhibitor and starting a different one is 14 days.\n* Patients with advanced, symptomatic visceral spread who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%.\n* Patients with documented pneumonitis/interstitial lung disease prior to registration.\n* Patients who have received major surgery within 28 days before starting trial therapy.\n* Patients who are taking strong or moderate CYP3A4 inducers or strong or moderate CYP3A4 inhibitors. See Section 4.4 for additional incompatibilities.\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to elacestrant. Note: Refer to exclusion criteria below for eligibility criteria related to study CDK4/6 inhibitors.\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Hypertension that is not controlled on medication\n  * Psychiatric illness/social situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients with refractory or chronic nausea, gastrointestinal conditions (including significant gastric or bowel resection or gastric bypass surgery), history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug. Similarly, patients who are unable to take/retain oral medications.","locations":[{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Coordinator","phone":"3126951301","email":"cancer@northwestern.edu"}],"primaryOutcomes":["Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":["palbociclib"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Phase 2: testing elacestrant, palbociclib, abemaciclib, ribociclib for Estrogen-receptor-positive Breast Cancer","inPlainEnglish":"Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.","whoItsFor":["Ages 18 Years to any","Patients must have histologically or cytologically confirmed ER-positive and HER2- negative breast cancer as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020, Wolff et al, 2018)","Note: In the context of this trial, ER status will be considered positive if \\>10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Note: Fresh biopsy is not a requirement","Patients must have a confirmed ESR1 mutation. Note: This information will be drawn from patients' treatment charts. Mutational analysis will be done as standard of care; there is no research-related mutational testing for this study. ctDNA may be used for mutational testing","Patients must have received at least 2 prior endocrine therapies, including a CDK4/6 inhibitor in the metastatic disease setting","Patients must be age ≥ 18 years. Patients of childbearing potential (POCBP) may be premenopausal, postmenopausal, or perimenopausal","Potential POCBP who may be menopausal and are \\< 55 years of age must have a serum follicle-stimulating hormone (FSH) level \\> 40 mIU/mL to confirm menopause","Patients must exhibit an how well you can do daily activities (ECOG score) of 0 or 1"],"whoShouldSkip":["Patients who have received prior elacestrant","Patients who have had chemotherapy or radiotherapy ≤ 28 days (6 weeks for nitrosureas or mitomycin C) prior to registration","Patients who have taken steroid therapy or any other immunosuppressive therapy within 7 days of first dose prior to trial treatment","Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 3) with the exception of alopecia","Patients who are receiving any other investigational agents. For patients who were previously on palbociclib, abemaciclib, or ribociclib, the washout period between stopping that CDK4/6 inhibitor and starting a different one is 14 days","Patients with advanced, symptomatic visceral spread who are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or liver involvement \\>50%","Patients with documented pneumonitis/interstitial lung disease prior to registration"],"whatHappens":"If you join, the listed intervention(s) are elacestrant, palbociclib, abemaciclib, ribociclib. The registry lists allocation as randomized. Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 174 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.729Z"},{"nctId":"NCT06066138","title":"A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","officialTitle":"A Feasibility Phase I Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nA type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow. One of these drugs (atezolizumab) is approved to treat certain cancers. Researchers want to find out if lower doses of this drug might provide the same benefit with fewer adverse effects.\n\nObjective:\n\nTo test different doses and timing of atezolizumab for people with cancer.\n\nEligibility:\n\nPeople aged 18 years and older with cancer that has spread locally or to other organs. They must be eligible for treatment with the study drug.\n\nDesign:\n\nParticipants will be screened. They will have blood tests and imaging scans. They will provide a sample of tissue from their tumor.\n\nAtezolizumab is administered through a tube attached to a needle inserted into a vein in the arm. Participants will take this drug alone or combined with other drugs prescribed for their care.\n\nThe first 2 treatments will be done per the FDA recommended dose and schedule. Before administering the second dose of the study drug, researchers will check the level of the drug in the participant s blood. Depending on those results, their 3rd dose will be scheduled 2 to 6 weeks later.\n\nFor the 3rd dose of the study drug, participants will switch to the FDA minimum dosage. Dosages of any other drugs will not change.\n\nResearchers will continue to test the levels of the drug in participants blood before each treatment for 16 weeks. After that, these levels will be tested every 3 months.\n\nStudy treatment may last up to 2 years....","conditions":["Locally Advanced Alveolar Soft Part Sarcoma","Metastatic Alveolar Soft Part Sarcoma","Locally Advanced Non Small Cell Lung Cancer","Metastatic Non Small Cell Lung Cancer","Locally Advanced Small Cell Lung Cancer","Metastatic Small Cell Lung Cancer","Locally Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma","Locally Advanced Melanoma","Metastatic Melanoma"],"keywords":["PD-L1","PD-1","Tecentriq","Immunotherapy"],"interventions":[{"type":"DRUG","name":"Atezolizumab"}],"enrollment":30,"startDate":"2025-11-04","completionDate":"2027-01-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants with a locally advanced or metastatic pathologically confirmed cancer whose NCI Licensed Independent Practitioner (LIP) determined they are candidates for treatment with atezolizumab, either alone or in combination with other FDA-approved drug(s), for example, TMB-high, PDL-1 positive, or other disease states that respond to PD(L)-1 inhibitors. Regimens with atezolizumab alone or in combination with agents that have previously demonstrated safety in published clinical trials may be used. An LIP may be either an MD, DO, PA, or NP and must be qualified for oncologic management per institutional practice.\n* Age \\>=18 years old.\n* Measurable disease per RECIST 1.1 criteria.\n* ECOG performance status of 0-2.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1,200/microliter\n  * Hemoglobin \\>9.0 g/dL\n  * Platelets \\>=75,000/microliter\n  * Total bilirubin \\<= 1.5 mg/dL, except in participants with Gilbert s Syndrome who must have a total bilirubin less than 3.0 mg/dL\n  * Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \\<=2.5 X institutional upper limit of normal (ULN)\n  * Creatinine Clearance (CrCl) \\>=30 mL/min/1.73 m\\^2 (calculated using the Cockcroft-Gault formula).\n  * Serum albumin \\> 3 g/dL\n* Individuals of child-bearing potential (IOCBP) must agree to use a highly effective method of contraception (hormonal, intrauterine device (IUD), surgical sterilization) for the duration of the study treatment and up to 5 months after the last dose of the atezolizumab (restriction period). NOTE: abstinence, defined as no vaginal heterosexual intercourse within 6 months prior to the treatment initiation and willingness to continue abstinence for restriction period is also acceptable.\n\nIndividuals who can father children must agree to use an effective method of contraception (barrier, surgical sterilization) at study entry and up to 5 months after the last dose of the atezolizumab.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 5 months after atezolizumab treatment discontinuation.\n* Participants with history of human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and have undetectable viral load.\n* Participants with history of chronic hepatitis B virus (HBV) infection must be on suppressive therapy, if indicated, and have undetectable HBV viral load.\n* Participants with history of hepatitis C virus (HCV) infection must have an undetectable HCV viral load.\n* Participants with history of treated brain metastases must have follow-up brain imaging after central nervous system (CNS)-directed therapy with no evidence of progression.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible.\n* All participants must have the ability to understand and willingness to sign a written informed consent.\n\nEXCLUSION CRITERIA:\n\nParticipants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation.\n\n* Participants who have received immunostimulatory agents, including, but not limited to, IFN-alpha, IFN-gamma, or IL-2, immunosuppressive medications, and any herbal medicines within 1 month prior to study treatment initiation. NOTE: Physiologic doses of systemic steroids (\\<= 10 mg prednisone or equivalent) or local (e.g., topical, nasal, intraarticular, inhaled) steroid use is permitted.\n* Prior treatment with CD137 agonists\n* Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation.\n* History or risk of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone.\n  * Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen.\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:\n\n    * Rash must cover less than 10% of body surface area (BSA)\n    * Disease is well controlled at screening and only requiring low potency topical steroids\n    * No acute exacerbations of underlying condition within 12 months prior to study treatment initiation (not requiring psoralen plus ultraviolet A radiation \\[PUVA\\], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids) within 12 months prior to study treatment initiation.\n* Persisting toxicity related to prior therapy of Grade \\>1 per Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 unless deemed not clinically significant or irreversible. NOTE: alopecia and sensory neuropathy Grade \\<= 2 are acceptable.\n* Participants with prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n* History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation\n* Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment\n* Active tuberculosis at screening\n* History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. Note: History of radiation pneumonitis in the radiation field (fibrosis) is permitted\n* Participants with significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident (https://www.heart.org/en/health-topics/heart-failure/what-isheart-failure/classes-of-heart-failure), unstable arrhythmia, or unstable angina within 3 months prior to study treatment initiation.\n* Pregnancy (confirmed with Beta-Human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test in IOCBP performed at screening).\n* Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Medical Oncology Referral Office","phone":"(240) 760-6050","email":"ncimo_referrals@nih.gov"},{"name":"James L Gulley, M.D.","phone":"(301) 480-7164","email":"gulleyj@mail.nih.gov"}],"primaryOutcomes":["Feasibility of reducing drug exposure while maintaining plasma drug concentration"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","liver-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Atezolizumab for Locally Advanced Alveolar Soft Part Sarcoma","inPlainEnglish":"Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment. These drugs help the body s immune system fight cancer by blocking proteins that cause cancer cells to grow.","whoItsFor":["Ages 18 Years to 120 Years","Age \\>=18 years old","Measurable disease per RECIST 1.1 criteria","how well you can do daily activities (ECOG score) of 0-2","Participants must have adequate organ and marrow function as defined below:","Absolute neutrophil count (ANC) \\>=1,200/microliter","Hemoglobin \\>9.0 g/dL","Platelets \\>=75,000/microliter"],"whoShouldSkip":["Participants who have received an investigational agent for treating participants' disease not approved by FDA within 28 days prior to study treatment initiation","Prior treatment with CD137 agonists","Prior treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies; (including atezolizumab) within 28 days prior to study treatment initiation","Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone","Participants with controlled Type 1 diabetes mellitus on a stable insulin regimen","Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis would be excluded) are permitted provided all of the following conditions are met:","Rash must cover less than 10% of body surface area (BSA)"],"whatHappens":"If you join, the listed intervention(s) are Atezolizumab. The registry lists allocation as na. Background: A type of drug called monoclonal antibody immune checkpoint inhibitors are often used in cancer treatment.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.739Z"},{"nctId":"NCT06068049","title":"OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain","officialTitle":"An Ambispective, Non-interventional, Multiple Cohort Study to Assess the Management of Osimertinib Treatment in Patients With EGFRm Non-small Cell Lung Cancer Under Real-world Conditions in Spain","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers.\n\nOsimertinib is indicated as monotherapy for the first-line (1L) treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations in the EGFR, for the treatment of adult patients with EGFR T790M mutation-positive locally advanced or metastatic NSCLC, for the adjuvant treatment of adult patients with NSCLC stages IB-IIIA after complete resection of the tumor that has activating mutations of the EGFR, for the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutation and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of adult patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations.\n\nThe FLAURA trial showed that treatment with osimertinib significantly prolongs PFS and improves overall survival (OS) compared to standard EGFR tyrosine kinase inhibitors.\n\nThe results of the ADAURA study showed a reduction in the risk of recurrence or death by 83% in stages II to IIIA, and in 80% in stages IB-IIIA. Additionally, osimertinib demonstrated a highly statistically significant improvement in DFS and HRQoL was maintained.\n\nThe FLAURA2 trial showed that 1L treatment with osimertinib-chemotherapy led to significantly longer progression-free survival than osimertinib monotherapy among patients with EGFR mutated (EGFRm) advanced NSCLC.\n\nThe LAURA trial showed that treatment with osimertinib after chemoradiotherapy resulted in significantly longer PFS than placebo among patients with unresectable stage III EGFRm NSCLC.\n\nTo date, there are no real-world data on osimertinib either in 1L treatment in locally advanced or metastatic EGFRm NSCLC nor as adjuvant treatment, in early stages of cancer, regarding effectiveness, adherence, treatment exposure and quality of life (QoL), among others, and in particular for the use of osimertinib in subpopulations less represented in pivotal trials such as elderly or patients with uncommon EGFR mutations. Furthermore, the duration of treatment in real life in Spain is also a gap, as it appears to be longer than in clinical trials, which means that there are patients who are treated beyond progression.\n\nTherefore, this observational ambispective study based on real-world data aims to provide data on osimertinib use as adjuvant treatment in adult patients diagnosed with stages IB-IIIA EGFRm NSCLC, in 1L treatment in patients with locally advanced or metastatic EGFRm NSCLC, as consolidation treatment in patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy, and in combination with pemetrexed and platinum-based chemotherapy in patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution. Specifically, the study will focus on patient characteristics, adherence, treatment exposure, administration, survival, quality of life, effectiveness and safety providing insights into osimertinib use in daily practice for patients with EGFRm NSCLC, where there are current evidence gaps.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[],"enrollment":500,"startDate":"2023-07-28","completionDate":"2029-06-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female or male patients, treated with osimertinib\n* Age ≥ 18 years at starts of osimertinib treatment (i.e., index date).\n* Patients histologically diagnosed with EGFRm NSCLC (before index date):\n\n  * Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1).\n  * Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2).\n  * Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3).\n  * Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4).\n* Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study.\n\nExclusion Criteria:\n\n* Osimertinib treatment administration in a clinical trial setting.","locations":[{"facility":"Research Site","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Alicante","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"C Rdoba","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"El Palmar","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Girona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Granada","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jaén","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Las Palmas de Gran Canaria","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"León","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lleida","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ourense","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Palma","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sabadell","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santa Cruz de Tenerife","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santander","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santiago de Compostela","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Valladolid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Vigo","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["To evaluate the effectiveness of osimertinib in terms of median OS in patients with locally advanced or metastatic EGFRm NSCLC (Cohort 1).","To evaluate the effectiveness of osimertinib in terms of 4-year rwDFS rate in patients with stages IB-IIIA EGFRm NSCLC (Cohort 2).","To evaluate the effectiveness of osimertinib in combination with pemetrexed and platinum-based chemotherapy in terms of 3-year OS in adult patients with advanced NSCLC whose tumours have EGFRm exon 19 deletions or exon 21 (L858R) substitution (Cohort 3).","To evaluate the effectiveness of osimertinib (median rwPFS) in patients with locally advanced, unresectable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations whose disease is stable during or after platinum-based CRT (Cohort 4)."],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["osimertinib"],"locationSlugs":["a-coru-a-spain","alicante-spain","barcelona-spain","c-rdoba-spain","el-palmar-spain","girona-spain","granada-spain","ja-n-spain","las-palmas-de-gran-canaria-spain","le-n-spain","lleida-spain","madrid-spain","m-laga-spain","ourense-spain","palma-spain","sabadell-spain","salamanca-spain","santa-cruz-de-tenerife-spain","santander-spain","santiago-de-compostela-spain","seville-spain","valencia-spain","valladolid-spain","vigo-spain","zaragoza-spain"],"enrichment":{"headline":"OSIREAL - Osimertinib RWE on EGFRm NSCLC in Spain","inPlainEnglish":"Lung cancer (LC) is the tumor responsible for the highest mortality worldwide. Lung adenocarcinoma is the major subtype of lung cancer and represents the deadliest human cancer, affecting current-, ex-, and even non-smokers.","whoItsFor":["Ages 18 Years to any","Female or male patients, treated with osimertinib","Age ≥ 18 years at starts of osimertinib treatment (i.e., index date)","Patients histologically diagnosed with EGFRm NSCLC (before index date):","Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1)","Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2)","Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3)","Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4)"],"whoShouldSkip":["Osimertinib treatment administration in a clinical trial setting"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 25 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.685Z"},{"nctId":"NCT06071377","title":"Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)","officialTitle":"Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Alliance for Sickle Cell Centers","sponsorClass":"OTHER","summary":"The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.","conditions":["Sickle Cell Trait"],"keywords":[],"interventions":[{"type":"OTHER","name":"Biologic Specimen Collection"}],"enrollment":1000,"startDate":"2023-04-01","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Are willing to voluntarily participate and sign the study consent\n2. Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status\n3. Adults ages 18 and older\n\nExclusion Criteria:\n\n1. Unwilling to sign consent\n2. Known end-stage renal disease or dialysis\n3. Known SCD (including sickle cell-beta thalassemia)\n4. People who do not have SCT","locations":[{"facility":"University of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nemours Children's Hospital","city":"Wilmington","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Functional Fluidics","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Health Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie Kanter, MD","phone":"(202) 596-1548","email":"jkanter@sicklecellcenters.org"}],"primaryOutcomes":["Hemoglobin variant quantification"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","wilmington-delaware","indianapolis-indiana","detroit-michigan","chapel-hill-north-carolina","durham-north-carolina","greenville-north-carolina","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Biologic Specimen Collection for Sickle Cell Trait","inPlainEnglish":"The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.","whoItsFor":["Ages 18 Years to any","Are willing to voluntarily participate and sign the study consent","Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status","Adults ages 18 and older"],"whoShouldSkip":["Unwilling to sign consent","Known end-stage renal disease or dialysis","Known SCD (including sickle cell-beta thalassemia)","People who do not have SCT"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.845Z"},{"nctId":"NCT06079671","title":"Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer (eVOLVE-Cervical)","officialTitle":"A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a phase III, randomized, double-blind, placebo-controlled, multi-center, global study to explore the efficacy and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.","conditions":["Locally Advanced Cervical Cancer"],"keywords":["Locally Advanced Cervical Cancer;","Adolescent and Young Adult;","Volrustomig"],"interventions":[{"type":"BIOLOGICAL","name":"Volrustomig"},{"type":"OTHER","name":"Placebo"}],"enrollment":800,"startDate":"2023-09-22","completionDate":"2027-11-26","sex":"FEMALE","minAge":"15 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nFor inclusion in the study, patients should fulfill the following criteria:\n\n1. Female.\n2. Aged at least 15 years at the time of screening. Note: Participants \\< 18 years of age: physical changes should be aligned with Tanner Stage III.\n3. Body weight \\> 35 kg.\n4. Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease.\n5. Initial staging procedures performed no more than 56 days prior to the first dose of CCRT.\n6. Provision of FFPE tumor sample to assess the PD-L1 expression.\n7. Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent.\n8. WHO/ECOG performance status of 0 or 1; duration of life expectancy of ≥ 12 weeks.\n9. Adequate organ and bone marrow function.\n10. Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nPatients should not enter the study if any of the following exclusion criteria are fulfilled:\n\n1. Diagnosis of small cell (neuroendocrine) or mucinous adenocarcinoma of cervical cancer.\n2. Evidence of metastatic disease.\n3. Intent to administer a fertility-sparing treatment regimen.\n4. History of organ transplant or allogenic stem cell transplant.\n5. History of active primary immunodeficiency or active or prior documented autoimmune or inflammatory disorders.\n6. Uncontrolled intercurrent illness.\n7. History of another primary malignancy except for a) Malignancy treated with curative intent with no known active disease ≥2 years before the first dose of study intervention; b) Adequately treated nonmelanoma skin cancer or lentigo maligna, or carcinoma in situ without evidence of disease.\n8. Unresolved toxicities from previous CCRT except for irreversible toxicity that is not reasonably expected to be exacerbated.\n9. Prior history or presence of vesicovaginal, colovaginal, or rectovaginal fistula.\n10. History of anaphylaxis to any biologic therapy or vaccine.\n11. Current or prior use of immunosuppressive medication within 14 days before the first dose of the study intervention is excluded. The following are exceptions to this criterion: a) Intranasal, inhaled, topical steroids, or local steroid injections (eg, intraarticular injection); b) Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication or chemotherapy premedication) or a single dose for palliative purpose (eg, pain control); c) Physiologic doses of oral corticosteroids, ie, not exceeding 10 mg/day of prednisone (or equivalent) in the preceding 14 days.\n12. Patients who have undergone a previous hysterectomy, including a supracervical hysterectomy, or will have a hysterectomy as part of their initial cervical cancer therapy.\n13. Any prior (besides prior CCRT) or concurrent treatment for cervical cancer.\n14. Major surgical procedures within 4 weeks prior to the first dose of the study intervention or still recovering from prior surgery.\n15. Exposure to immune mediated therapy prior to the study for any indication.\n16. Receipt of live attenuated vaccine within 30 days prior to the first dose of the study intervention.\n17. Participants with a known allergy or hypersensitivity to the study intervention, or any excipients of the study intervention.","locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Tucson","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"La Jolla","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"West Hollywood","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research 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3: testing Volrustomig for Locally Advanced Cervical Cancer","inPlainEnglish":"This is a phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multi-center, global study to explore the how well it works and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.","whoItsFor":["Ages 15 Years to any","Women only","For inclusion in the study, patients should fulfill the following criteria:","Aged at least 15 years at the time of screening. Note: Participants \\< 18 years of age: physical changes should be aligned with Tanner Stage III","Body weight \\> 35 kg","Histologically documented FIGO 2018 Stage IIIA to IVA cervical adenocarcinoma, cervical squamous carcinoma, or cervical adenosquamous carcinoma, with no evidence of metastatic disease","Initial staging procedures performed no more than 56 days prior to the first dose of CCRT","Provision of FFPE tumor sample to assess the PD-L1 expression","Must not have progressed following CCRT, participants with persistent disease after definitive CCRT must not be amenable to other available therapies with curative intent"],"whoShouldSkip":["Patients should not enter the study if any of the following"],"whatHappens":"If you join, the listed intervention(s) are Volrustomig, or Placebo. The registry lists allocation as randomized. This is a phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multi-center, global study to explore the how well it works and safety of volrustomig in women with high-risk LACC (FIGO 2018 stage IIIA to IVA cervical cancer) who have not progressed following platinum-based CCRT.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 800 people at 161 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.329Z"},{"nctId":"NCT06080347","title":"Effect of Anti-inflammatory Diet in Osteoarthritis","officialTitle":"An Evaluator-blinded Randomized Controlled Trial Study of the Effect of Anti-inflammatory Diet in Subjects With Osteoarthritis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites. The current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with Osteoarthritis, and the role of microbiome and circulating metabolites.","conditions":["Osteoarthritis, Knee"],"keywords":[],"interventions":[{"type":"OTHER","name":"Anti-inflammatory Diet"},{"type":"OTHER","name":"Healthy Diet"}],"enrollment":72,"startDate":"2023-10-01","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Unilateral radiographic symptomatic KOA\n* No changes in therapy during the previous 3 months\n* Interested in dietary intervention and able to provide consent and attend follow-up visits\n\nExclusion Criteria:\n\n* Previous knee surgery\n* Severe radiographic disease (KL grade 4)\n* Rheumatoid Arthritis\n* Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)\n* Use of corticosteroids and/or intra-articular injections during the preceding 3 months\n* Use of fish oils and glucosamine\n* Participation in a weight loss program in the preceding 6 months\n* Recent changes in physical activity levels\n* Regular smoking\n* Patients with food allergies\n* Patient with other medical conditions that will impair the ability to participate in a nutritional study\n* Plan to change systemic therapy\n* Patients unwilling to change dietary habits","locations":[{"facility":"University of California","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Monica Guma, M.D., PhD","phone":"8588226523","email":"mguma@health.ucsd.edu"}],"primaryOutcomes":["Change in Knee Osteoarthritis Pain"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: Anti-inflammatory Diet for Osteoarthritis, Knee","inPlainEnglish":"In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. The investigators also observed change in microbiome and circulating metabolites.","whoItsFor":["Ages 18 Years to any","Unilateral radiographic symptomatic KOA","No changes in therapy during the previous 3 months"],"whoShouldSkip":["Previous knee surgery","Severe radiographic disease (KL grade 4)","Rheumatoid Arthritis","Any Abnormal blood values in the comprehensive metabolic panel test at screen (Abnormality will be defined based on standard reference ranges)","Use of corticosteroids and/or intra-articular injections during the preceding 3 months","Use of fish oils and glucosamine","Participation in a weight loss program in the preceding 6 months"],"whatHappens":"If you join, the listed intervention(s) are Anti-inflammatory Diet, or Healthy Diet. The registry lists allocation as randomized. In a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at San Diego. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.506Z"},{"nctId":"NCT06083584","title":"Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis","officialTitle":"Development of Targeted RNA-Seq for Amyotrophic Lateral Sclerosis Diagnosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre Hospitalier Universitaire de Nīmes","sponsorClass":"OTHER","summary":"Genetic diagnosis of Amyotrophic Lateral Sclerosis (ALS) could identify the origin of the disease, potentially allowing the patient to pursue targeted/gene therapy. However, many familial forms of ALS are genetically undiagnosed, either because no variant has been detected in the genes of interest, or because the detected variant(s) have uncertain significance. Currently, molecular diagnosis takes place in two stages: 1) Search for the GGGGCC expansion in the C9ORF72 gene by RP-PCR; 2) Analysis of the coding regions by high-throughput sequencing of a panel of 30 genes involved in ALS.\n\nMany of these variants of uncertain significance affect splicing. Their impact can be predicted using in silico tools, but only an analysis of the patient's RNA can confirm their pathogenic nature. Currently, the analysis of transcripts is only done a posteriori, when a variant predicted to impact splicing is detected on the patient's DNA. RT-PCR followed by Sanger sequencing then verifies the impact of the splice variants. This method confirmed the impact of certain splice variants in patients. However, this method is time-consuming and requires custom development, and is mutation/gene/patient-dependent. In contrast, high-throughput RNA sequencing (RNA-Seq) simultaneously analyzes the splicing of numerous genes, with a global approach, applicable to all patients. This approach avoids the custom design of primers, which can be biased by the interpretation of splicing predictions, while RNA-Seq systematically captures and sequences all the transcripts. Finally, RNA-Seq provides additional information compared to DNA sequencing such as the detection of exon skipping, intron inclusion, and the creation of fusion transcripts.\n\nIn the GTEx project (GTEx Consortium, 2013), expression levels of human genome transcripts were quantified by RNA-Seq. Using these results, the study investigators measured expression of transcripts of known ALS genes in whole blood. Applying a threshold value of 0.5 transcripts per million reads (TPM), 25 of the 30 ALS genes currently analyzed by NGS in routine diagnostics at Nîmes University Hospital could be eligible for a complete analysis by RNA-Seq. None of the French laboratories carrying out genetic analyzes of ALS has yet developed RNA-Seq as a routine diagnostic tool. The study laboratory receives more than 600 requests for genetic diagnosis of ALS patients per year. The aim of this study is therefore to develop a global method for analyzing RNA transcripts of ALS genes to categorize the mutations to improve the diagnostic management of patients.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"OTHER","name":"RNA sequencing"}],"enrollment":192,"startDate":"2023-11-22","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a prescription for a genetic diagnosis of ALS (or familial hypercholesterolemia for the control cohort)\n* Have given their informed consent for the genetic study and the biobank\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The patient is under safeguard of justice or state guardianship","locations":[{"facility":"CHU de Bordeaux","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Lyon","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"La Timone","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Montpellier","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nîmes","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Claire Guissart","phone":"04 66 68 32 07","email":"claire.guissart@chu-nimes.fr"}],"primaryOutcomes":["Concordance between the RNA-Seq results (index text) versus RT-PCR followed by Sanger sequencing (reference technique) on positive plus negative controls"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bordeaux-france","clermont-ferrand-france","lyon-france","marseille-france","montpellier-france","n-mes-france","toulouse-france"],"enrichment":{"headline":"Not a traditional drug phase: RNA sequencing for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Genetic diagnosis of Amyotrophic Lateral Sclerosis (ALS) could identify the origin of the disease, potentially allowing the patient to pursue targeted/gene therapy. However, many familial forms of ALS are genetically undiagnosed, either because no variant has been detected in the genes of interest, or because the detected variant(s) have uncertain significance.","whoItsFor":["Ages 18 Years to any","Have a prescription for a genetic diagnosis of ALS (or familial hypercholesterolemia for the control cohort)","The patient must be a member or beneficiary of a health insurance plan"],"whoShouldSkip":["The patient is under safeguard of justice or state guardianship"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 192 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.607Z"},{"nctId":"NCT06084195","title":"Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging","officialTitle":"Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","sponsorClass":"OTHER","summary":"The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance","conditions":["High Grade Serous Ovarian Cancer"],"keywords":["Radiomics","Ovarian cancer","Genomics","Proteomics","Immune Tumor Microenvironment"],"interventions":[{"type":"BIOLOGICAL","name":"Blood sample and tissue sample"}],"enrollment":120,"startDate":"2023-12-19","completionDate":"2027-10","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged \\>18\n* Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment\n* Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,\n* Patient who has given informed, written and express consent,\n* Patient affiliated with a French health insurance scheme.\n\nExclusion Criteria:\n\n* Early-stage disease (FIGO \\<IIIB) or presence of extraperitoneal metastases,\n* Patient who will not have surgery\n* Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,\n* Patient under guardianship, curatorship or safeguarding of justice,\n* Pregnant and/or nursing patient,\n* Patient with a history of other cancers within 5 years/10 years prior to inclusion","locations":[{"facility":"NOUGARET Stephanie","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"MOUSSION Aurore","phone":"0467613102","email":"aurore.moussion@icm.unicancer.fr"},{"name":"Texier Emmanuelle","phone":"0467613102","email":"emmanuelle.texier@icm.unicancer.fr"}],"primaryOutcomes":["the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cancer."],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":[],"locationSlugs":["montpellier-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Blood sample and tissue sample for High Grade Serous Ovarian Cancer","inPlainEnglish":"The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance","whoItsFor":["Ages 18 Years to any","Women only","Pathologically proven HGSOC at an advanced stage (FIGO IIIB or IIIC) which can benefit from surgery with or without prior neoadjuvant treatment","Willingness and ability to comply with planned visits, treatment plan, laboratory tests and other study procedures,","Patient who has given informed, written and express consent,","Patient affiliated with a French health insurance scheme"],"whoShouldSkip":["Early-stage disease (FIGO \\<IIIB) or presence of extraperitoneal metastases,","Patient who will not have surgery","Patient whose regular follow-up is impossible for psychological, family, social or geographical reasons,","Patient under guardianship, curatorship or safeguarding of justice,","Pregnant and/or nursing patient,","Patient with a history of other cancers within 5 years/10 years prior to inclusion"],"whatHappens":"If you join, the listed intervention(s) are Blood sample and tissue sample. The registry lists allocation as na. The objective of this study is to explore the integration of in vivo and ex vivo of MRI with histology and molecular assessments to advance non-invasive characterization of tumor heterogeneity in high-grade serous ovarian cance","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Montpellier. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.173Z"},{"nctId":"NCT06088771","title":"Neoadjuvant Dupilumab and Cemiplimab in Patients With Early-stage Resectable NSCLC","officialTitle":"A Phase 1/2 Study of Combined Treatment With Dupilumab (Anti-IL-4Ra) and Cemiplimab (Anti-PD-1) in Patients With Early-stage, Resectable NSCLC","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy. On Day 1, participants will receive neoadjuvant therapy consisting of 600 mg of dupilumab (2 SC injections of 300 mg) and 350 mg of IV cemiplimab. Participants will undergo standard of care surgery, which will be scheduled within 7 days of Day 15. Participants will be followed up 30 days following administration of dupilumab and cemiplimab for adverse event (AE) and dose limiting toxicity (DLT) monitoring. Participants will be offered adjuvant therapy as per standard of care, outside the context of this clinical treatment, and undergo subsequent standard of care monitoring for recurrence. The study team will monitor the status of the participant through chart review, or by telephone should the patient not continue to follow with a physician at Mount Sinai, for up to 5 years.","conditions":["Non-Small Cell Lung Cancer"],"keywords":["Neoadjuvant","Dupilumab","Cemiplimab","Resectable","anti-PD1","Anti-IL-4Ra"],"interventions":[{"type":"BIOLOGICAL","name":"Dupilumab"},{"type":"BIOLOGICAL","name":"Cemiplimab"}],"enrollment":21,"startDate":"2024-10-09","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Histological diagnosis of NSCLC is required before initiation of treatment, however, patients who have a smoking history and radiographic findings highly suggestive of a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy may be consented so as they can undergo the biopsy mandated for research at the same time to avoid second procedure. Pre-treatment biopsies are mandatory before treatment initiation. Patients with NSCLC must have T1b or more advanced (\\>1cm primary tumor). Only patients whose tumor is deemed amenable to surgical or needle biopsy by a multidisciplinary team including a medical oncologist and an interventionalist (radiologist, surgeon, pulmonologist) may be enrolled.\n* Patient must be willing and able to provide blood samples (6 heparinized tubes, 2 streck tubes, roughly 60mL) at the time points indicated in the Study Calendar.\n* Patient must be willing and able to have core needle biopsies (Goal 3-6 biopsies, final number to be determined by the surgeon and radiologist performing the procedure as safe) of tumor prior to initiation of therapy.\n* Age ≥ 18 years.\n* ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy.\n* Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist.\n* Women of child-bearing potential and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy\n\nShould a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\n  * Ability to understand and the willingness to sign a written informed consent.\n  * Adequate organ and marrow function as defined below:\n* System/Laboratory Value\n\n  * Hematologic:\n\nAbsolute neutrophil count (ANC) ≥1,000 /mcL Platelets ≥75,000 /mcL Hemoglobin ≥9 g/dL\n\n* Renal\\* Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥60 mL/min for patient with creatinine levels \\> 1.5 X institutional ULN Creatinine clearance should be calculated per institutional standard.\n* Hepatic\\* Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN AST and ALT ≤ 2.5 X ULN Albumin \\>2.5 mg/dL\n* Coagulation\\* International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants\n* Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless patient is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants\n\n  * If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the lab values will not be used to exclude patient from this trial. Similarly, for patients with elevated bilirubin due to biliary obstruction from tumor, this will not serve as an exclusion criterion. This determination will be made by the PI.\n\nExclusion Criteria:\n\n* Patients with history of autoimmune disorder or any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting treatment.\n* Patients without any smoking history, or any patient for whom we already have tissue or ctDNA evidence of an activating EGFR mutation or an ALK or ROS1 rearrangement.\n* Patients who have had chemotherapy or radiotherapy within 4 months prior to entering the study for a different primary tumor, nor can they have received locoregional therapy (e.g. radiation) for the target lesion that will be biopsied and subsequently resected. Previous therapy for a different cancer (a different primary) is acceptable.\n* Patients may not be receiving any other investigational agents.\n* Patients with metastatic disease, for whom the intent of surgery would not be curative.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements, as determined the treating investigator.\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n* Use of another immunomodulatory drug, including dupilumab, that may confound interpretation of clinical and biospecimen analysis, within 8 weeks of enrollment.\n* Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the administration of trial treatment. Patients on chronic steroids equivalent to ≤ 10mg prednisone will not be excluded.\n* Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.\n* Has a known additional malignancy that is progressing and requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or anal cancer, prostate cancer on stable dose of hormonal therapy without rising PSA, and breast cancer whom have been treated with curative intent, who may be on hormonal therapy.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen.\n* Has known active Hepatitis B (e.g., HBV detected by PCR (\\>200 IU/ml) or active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* Patients whom have recently started (\\>14d from C1D1) antiviral therapy may go on to the trial.\n* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n* Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)\n* Principle investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.\n* Any evidence of current ILD or pneumonitis or a prior history of ILD or pneumonitis requiring oral or IV glucocorticoids.","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas Marron, MD, PhD","phone":"(212) 824-9472","email":"thomas.marron@mssm.edu"},{"name":"Katherine Vandris","phone":"","email":"Katherine.Vandris@mssm.edu"}],"primaryOutcomes":["Frequency of dose limiting toxicities (DLTs)","Percentage of dose limiting toxicities (DLT)","Major pathological response (MPR)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["dupilumab"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Dupilumab for Non-Small Cell Lung Cancer","inPlainEnglish":"This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC). The study will include participants with a confirmed diagnosis of NSCLC who are deemed to be surgical candidates, or patients who have a smoking history and radiographic findings highly suggestive if a diagnosis of NSCLC who are scheduled to undergo diagnostic biopsy.","whoItsFor":["Ages 18 Years to any","Patient must be willing and able to have core needle biopsies (Goal 3-6 biopsies, final number to be determined by the surgeon and radiologist performing the procedure as safe) of tumor prior to initiation of therapy","ECOG 0-1. The exception will be patients carrying long term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy","Patient is determined to be a surgical candidate for resection of their tumor by a multidisciplinary team including a surgeon and a medical oncologist","Women of child-bearing potential and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy","Has not undergone a hysterectomy or bilateral oophorectomy; or","Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)","Adequate organ and marrow function as defined below:"],"whoShouldSkip":["Patients with history of autoimmune disorder or any patient who has used an immunomodulatory drug, such as dupilumab, within 8 weeks of starting treatment","Patients without any smoking history, or any patient for whom we already have tissue or ctDNA evidence of an activating EGFR mutation or an ALK or ROS1 rearrangement","Patients may not be receiving any other investigational agents","Patients with metastatic disease, for whom the intent of surgery would not be curative","Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants","Use of another immunomodulatory drug, including dupilumab, that may confound interpretation of clinical and biospecimen analysis, within 8 weeks of enrollment","Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the administration of trial treatment. Patients on chronic steroids equivalent to ≤ 10mg prednisone will not be excluded"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Cemiplimab. The registry lists allocation as na. This is a phase 1/2 study of combined treatment with dupilumab (anti-IL-4Ra) and cemiplimab (anti-PD-1) in patients with early-stage, resectable non-small cell lung cancer (NSCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 21 people at New York. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.714Z"},{"nctId":"NCT06089161","title":"Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks","officialTitle":"Personalized Obstructive Sleep Apnea Treatment and Effects on Alzheimer's Disease Biomarkers and Cognition Among Blacks","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Miami","sponsorClass":"OTHER","summary":"The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).","conditions":["Sleep Apnea"],"keywords":[],"interventions":[{"type":"OTHER","name":"Standard of Care"},{"type":"BEHAVIORAL","name":"Personalized OSA Treatment"}],"enrollment":330,"startDate":"2024-03-19","completionDate":"2027-11-30","sex":"ALL","minAge":"55 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Self-reported race/ethnicity as African American, African, Afro-latino, Caribbean or black\n* Ages 55-85 years\n* accessible by phone\n* OSA diagnosis\n* consent, including permission to release medical data\n\nExclusion Criteria:\n\n* progressive illnesses in which disability or death is expected within 1 year\n* impaired cognitive/ functional ability precluding participation\n* intention to move within the year\n* and a family member currently enrolled.","locations":[{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Girardin Jean-Louis, PhD","phone":"3052430776","email":"girardin.jean-louis@miami.edu"}],"primaryOutcomes":["Proportion of participants adherence to OSA treatment"],"hasResults":false,"conditionSlugs":["alzheimer","sleep-apnea"],"drugSlugs":[],"locationSlugs":["miami-florida"],"enrichment":{"headline":"Not a traditional drug phase: Standard of Care for Sleep Apnea","inPlainEnglish":"The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).","whoItsFor":["Ages 55 Years to 85 Years","Self-reported race/ethnicity as African American, African, Afro-latino, Caribbean or black","accessible by phone","consent, including permission to release medical data"],"whoShouldSkip":["progressive illnesses in which disability or death is expected within 1 year","impaired cognitive/ functional ability precluding participation","intention to move within the year","and a family member currently enrolled"],"whatHappens":"If you join, the listed intervention(s) are Standard of Care, or Personalized OSA Treatment. The registry lists allocation as randomized. The purpose of this research is to see how effective the Personalized obstructive sleep apnea (OSA) Treatment Adherence Model called PRAISE is in helping the patient stick to the physician recommended OSA treatment plan Positive Airway Pressure (PAP).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 330 people at Miami. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.948Z"},{"nctId":"NCT06089590","title":"Ibd CAncer and seRious Infections in France (I-CARE 2)","officialTitle":"Ibd CAncer and seRious Infections in France (I-CARE 2)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","sponsorClass":"OTHER","summary":"This is a French prospective longitudinal observational multicentre cohort study.\n\nPrimary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.","conditions":["IBD","Ulcerative Colitis","Crohn Disease"],"keywords":["UC","CD"],"interventions":[{"type":"OTHER","name":"Non-interventional"}],"enrollment":6000,"startDate":"2024-01-25","completionDate":"2031-03-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.\n* Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.\n\nExclusion Criteria:\n\n* Patient unable to sign the informed consent form\n* Patient with no regular access to internet\n* Patient refusing to sign the informed consent form\n* Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)","locations":[{"facility":"CHU Amiens Picardie","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"APHP Hôpital Saint Antoine","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marie Coisnon","phone":"09 72 57 61 60","email":"mcoisnon@getaid.org"},{"name":"Charlotte Mailhat","phone":"09 72 57 61 60","email":"cmailhat@getaid.org"}],"primaryOutcomes":["Number of SAE declared by patients (cancer, serious infections, arterial and venous thrombotic events)"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["amiens-france","paris-france"],"enrichment":{"headline":"Not a traditional drug phase: Non-interventional for IBD","inPlainEnglish":"This is a French prospective longitudinal watch-and-measure (no experimental treatment required) multicentre cohort study. Primary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.","whoItsFor":["Ages 18 Years to 75 Years","Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria"],"whoShouldSkip":["Patient with no regular access to internet","Patient enrolled in a randomly assigned Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 6,000 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.888Z"},{"nctId":"NCT06090422","title":"Ketamine for Combined Depression and Alcohol Use Disorder","officialTitle":"Ketamine for Combined Depression and Alcohol Use Disorder: A Blinded Randomized Active Placebo-controlled Trial (the KeDA Trial)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University Hospital of North Norway","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function. Participants will then be randomized to either ketamine (intervention) or midazolam (control). All participants will be admitted for standard inpatient addiction therapy while receiving ketamine or midazolam. Measures on safety, depression and alcohol use disorder will be repeatedly assessed during and after treatment. Final follow-up assessment is scheduled 6 months after baseline assessment.","conditions":["Depression","Alcohol Use Disorder"],"keywords":["Depression","Alcohol use disorder","Ketamine","Addiction"],"interventions":[{"type":"DRUG","name":"Ketamine Hydrochloride"},{"type":"DRUG","name":"Midazolam Hydrochloride"}],"enrollment":34,"startDate":"2025-01-20","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Please contact the project team for a full and detailed list of inclusion/exclusion criteria\n\nInclusion Criteria:\n\n* Currently abstinent from alcohol\n* At least moderate depression without psychotic features\n* Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20\n* Alcohol dependence\n* Admitted for inpatient addiction therapy at University Hospital of North Norway\n\nExclusion Criteria:\n\n* Intoxicated or in significant withdrawal from alcohol or drug use\n* Not able to give adequate informed consent\n* Current or past history of schizophrenia, schizophreniform disorder, paranoid delusional disorder, schizoaffective disorder\n* Current or historical diagnosis of schizophrenia in a first degree relative\n* Cardiovascular conditions: recent stroke (\\< 1 year from informed consent), recent myocardial infarction (\\< 1 year from informed consent), uncontrolled hypertension (\\>150/100 mm Hg) or recent arrhythmia (\\< 1 year from informed consent; clinically significant arrhythmia requiring treatment at hospital)\n* Liver (Child-Pughs Class C) or kidney (Creatinin clearance \\< 30 mL/min) failure\n* Heart failure (the New York Heart Association Functional Classification (NYHA) class III or IV)\n* Chronic respiratory failure (requiring long-term oxygen therapy (LTOT) and/or Global Initiative for Chronic Obstructive Lung Disease system (GOLD) stage 3 or higher)\n* Previous anaphylactic reaction to ketamine or midazolam\n* Illegal use of ketamine the last 6 months\n* Pregnancy or breastfeeding\n* Current or suspected increased intracranial pressure","locations":[{"facility":"Department of Addiction, University Hospital of North Norway","city":"Tromsø","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andreas W Blomkvist, M.D.","phone":"41694637","email":"andreas.wahl.blomkvist@unn.no"},{"name":"Ole K Grønli, Assoc Prof","phone":"91713535","email":"ole.k.gronli@unn.no"}],"primaryOutcomes":["Depression"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["troms-norway"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Ketamine Hydrochloride for Depression","inPlainEnglish":"The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder. After screening and enrollment, participants will undergo baseline assessments of depression, measures of alcohol use and craving, as well as neurocognitive function.","whoItsFor":["Ages 18 Years to 65 Years","Please contact the project team for a full and detailed list of inclusion/"],"whoShouldSkip":["who can join:","Currently abstinent from alcohol","At least moderate depression without psychotic features","Minimum Montgomery-Åsberg Depression Rating Scale (MADRS) of 20","Admitted for inpatient addiction therapy at University Hospital of North Norway"],"whatHappens":"If you join, the listed intervention(s) are Ketamine Hydrochloride, or Midazolam Hydrochloride. The registry lists allocation as randomized. The goal of this clinical trial is to investigate the effects of ketamine, in combination with standard inpatient addiction therapy, for adults with depression and alcohol use disorder.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 34 people at Tromsø. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.793Z"},{"nctId":"NCT06096038","title":"Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC","officialTitle":"Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"UNC Lineberger Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.\n\nHow many (dose) of the iC9.CAR. CSPG4 T cells are safe to use in patients without causing too many side effects, and what is the maximum dose that could be tolerated will be investigated. The information collected from the study would help cancer patients in the future.\n\nThere are two parts to this study. In part 1, blood will be collected to prepare the iC9.CAR-CSPG4 T cells. Disease fighting T cells will be isolated and modified to prepare the iC9.CAR-CSPG4 T cells. In part 2, the iC9.CAR-CSPG4 T cells are given by infusion after completion of lymphodepletion chemotherapy.\n\nThe data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD). Additionally, recommended phase 2 dose will be tested.\n\nEligible subjects will receive lymphodepletion chemotherapy standard followed by infusion of iC9-CAR.CSPG4 T cells. After treatment completion or discontinuation, subjects will be followed since involving gene transfer experiments.","conditions":["Head and Neck Cancer","Relapse","Recurrent","Refractory Cancer"],"keywords":["cellular therapy"],"interventions":[{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"},{"type":"BIOLOGICAL","name":"Cell Therapy"}],"enrollment":33,"startDate":"2024-04-05","completionDate":"2028-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nUnless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:\n\n1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.\n2. Age ≥ 18 years at the time of consent.\n3. Karnofsky score of \\> 60%\n4. Histologically or cytologically confirmed stage recurrent/metastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.\n\nExclusion Criteria:\n\n1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.\n2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.\n3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.","locations":[{"facility":"Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Catherine Cheng","phone":"+1 919-445-4208","email":"UNCImmunotherapy@med.unc.edu"},{"name":"Spencer SB Laing","phone":"+1 919-445-4175","email":"UNCImmunotherapy@med.unc.edu"}],"primaryOutcomes":["Toxicity: NCI-CTCAE","Toxicity: Cytokine Release Syndrome (CRS)","Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)","Dose Limiting Toxicity","Tumor inflammation-associated neurotoxicity (TIAN)"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":["car-t"],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Phase 1: testing Cyclophosphamide for Head and Neck Cancer","inPlainEnglish":"This study wants to test the whether it is safe and how hard side effects are to live with of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer. The iC9.CAR-CSPG4 treatment is experimental and has not been approved by the Food and Drug Administration.","whoItsFor":["Ages 18 Years to any","Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:","Age ≥ 18 years at the time of consent","Karnofsky score of \\> 60%","Histologically or cytologically confirmed stage recurrent/metastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx"],"whoShouldSkip":["Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months","Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement","Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine"],"whatHappens":"If you join, the listed intervention(s) are Cyclophosphamide, Fludarabine, or Cell Therapy. The registry lists allocation as na. This study wants to test the whether it is safe and how hard side effects are to live with of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the CSPG4 antigen (iC9.CAR-CSPG4 T cells) in patients with head and neck cancer that came back after receiving standard therapy for this cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 33 people at Chapel Hill. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.403Z"},{"nctId":"NCT06096857","title":"Cardamom and Topical Roseomonas in Atopic Dermatitis","officialTitle":"A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nAtopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD.\n\nObjective:\n\nTo test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD.\n\nEligibility:\n\nPeople aged 2 years and older with AD.\n\nDesign:\n\nAll study visits will be remote. Participants will have 5 visits over about 7 months.\n\nParticipants will be screened. Researchers will review their AD and medical history.\n\nParticipants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks.\n\nHalf of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have.\n\nDuring 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers.\n\nParticipants may opt to have pictures taken of their AD.\n\nParticipants will fill out 4 online questionnaires.","conditions":["Atopic Dermatitis","Eczema"],"keywords":["Eczema","Atopic Dermatitis","Roseomonas","Cardamom","Itch","Rash"],"interventions":[{"type":"DRUG","name":"Roseomonas mucosa (RSM2015) and Cardamom seeds"},{"type":"DRUG","name":"Placebo (sucrose)"}],"enrollment":120,"startDate":"2024-10-09","completionDate":"2027-01-01","sex":"ALL","minAge":"2 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Aged \\>=2 years\n2. Have a documented primary care provider near residence\n3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires)\n4. Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \\>=3 months before the screening visit\n\n   * Major Criteria: Must have \\>=3 basic features:\n\n     * Pruritus\n     * Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)\n     * Chronic or chronically relapsing dermatitis\n     * Personal or family history of atopy (asthma, allergic rhinitis, AD)\n   * Minor Criteria: Must have \\>=3 minor features:\n\n     * Xerosis\n     * Ichthyosis/palmar hyperlinearity, keratosis pilaris\n     * Immediate (type 1) skin-test reactivity\n     * Raised serum IgE\n     * Early age of onset\n     * Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity\n     * Tendency toward non-specific hand or foot dermatitis\n     * Nipple eczema\n     * Cheilitis\n     * Recurrent conjunctivitis\n     * Dennie-Morgan infraorbital fold\n     * Keratoconus\n     * Anterior subcapsular cataracts\n     * Orbital darkening\n     * Facial pallor, facial erythema\n     * Pityriasis alba\n     * Anterior neck folds\n     * Itch when sweating\n     * Intolerance to wool and lipid solvents\n     * Perifollicular accentuation\n     * Food intolerance\n     * Course influenced by environmental or emotional factors\n     * White dermographism, delayed blanch\n5. EASI \\>5 and/or an IGA \\>=1 at time of enrollment.\n6. Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and/or tubal ligation) or menopausal (age \\>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device.\n7. Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures.\n8. Participants/parents/guardians must have the ability to provide informed consent/assent as applicable.\n9. Willingness to perform visits virtually.\n\nEXCLUSION CRITERIA:\n\n1. Previous treatment of AD:\n\n   * Within 4 weeks prior to the baseline visit with any of the following:\n\n     * Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine\n     * Phototherapy or photochemotherapy for AD\n   * Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:\n\n     * Topical steroids or topical calcineurin inhibitors\n     * Janus kinase (JAK) inhibitors (oral or topical)\n     * Dupilumab or any other biologic agent\n     * Topical PDE4 inhibitor\n     * Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.\n     * Bleach baths\n2. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.\n3. Superficial skin infection requiring topical treatment within 1 week of baseline visit.\n4. Known or suspected history of immunosuppression or immunodeficiency.\n5. Existence of indwelling central line.\n6. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.\n7. Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.\n8. Self-reported pregnancy or breastfeeding.\n9. Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly will not be excluded.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jodi L Blake, R.N.","phone":"(301) 605-2896","email":"jodi.blake@nih.gov"},{"name":"Ian A Myles, M.D.","phone":"(301) 451-8420","email":"mylesi@niaid.nih.gov"}],"primaryOutcomes":["To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation."],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis","asthma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Roseomonas mucosa (RSM2015) and Cardamom seeds for Atopic Dermatitis","inPlainEnglish":"Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems.","whoItsFor":["Ages 2 Years to 100 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Have a documented primary care provider near residence","Fluency in English (applicable to participant or caregiver who will be answering questionnaires)","Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \\>=3 months before the screening visit","Major Criteria: Must have \\>=3 basic features:","Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)","Chronic or chronically relapsing dermatitis"],"whoShouldSkip":["Previous treatment of AD:","Within 4 weeks prior to the baseline visit with any of the following:","Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine","Phototherapy or photochemotherapy for AD","Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:","Topical steroids or topical calcineurin inhibitors","Janus kinase (JAK) inhibitors (oral or topical)"],"whatHappens":"If you join, the listed intervention(s) are Roseomonas mucosa (RSM2015) and Cardamom seeds, or Placebo (sucrose). The registry lists allocation as randomized. Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.829Z"},{"nctId":"NCT06098430","title":"Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)","officialTitle":"A Pilot Study of Prospective Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma (NLPHL)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"St. Jude Children's Research Hospital","sponsorClass":"OTHER","summary":"There is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). This study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (PROs) instruments.\n\nPrimary Objective:\n\n* To develop the data collection infrastructure required to prospectively collect longitudinal electronic patient-reported outcomes (PROs) survey instruments in adult and pediatric patients diagnosed with NLPHL.\n\nSecondary Objective:\n\n* To examine differences in baseline and longitudinal changes in PROs based on disease characteristics, disease status, and treatment strategies among adult and pediatric patients diagnosed with NLPHL.","conditions":["Nodular Lymphocyte-Predominant Hodgkin Lymphoma"],"keywords":[],"interventions":[],"enrollment":100,"startDate":"2024-04-04","completionDate":"2029-02","sex":"ALL","minAge":"8 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Age ≥ 8 years\n* Patient or their adult proxy must have verbal and written English language proficiency.\n* Pathologically confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible.\n* Patients or their adult proxy must be able to provide consent.\n* Patients and/or adult proxy must be able to complete electronic quality of life surveys\n\nExclusion Criteria\n\n* Age 7 years or less.\n* Patient or adult proxy does not have verbal and written English language proficiency.\n* Patients with histologic evidence of a composite lymphoma (NLPHL with a concurrent diagnosis of Hodgkin lymphoma, indolent non-Hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible.\n* Inability or unwillingness of research participant or legal guardian/representative to give consent.","locations":[{"facility":"Stanford University Medical Center","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Valerie Crabtree, PhD","phone":"888-226-4343","email":"referralinfo@stjude.org"},{"name":"Jessi Rogers Blake, BSN,RN,CCRP","phone":"901-595-4108","email":"jessi.rogers-blake@stjude.org"}],"primaryOutcomes":["Estimates of response rates","Patterns of individual per-patient survey completion"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["palo-alto-california","aurora-colorado","boston-massachusetts","hackensack-new-jersey","new-york-new-york","rochester-new-york","memphis-tennessee"],"enrichment":{"headline":"Patient-Reported Outcomes and Quality of Life in Adult and Pediatric Patients With Nodular Lymphocyte-Predo…","inPlainEnglish":"There is a pressing need to measure patient-reported symptoms in patients of all ages diagnosed with nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL). This study aims to measure longitudinal symptom burden and treatment tolerability utilizing validated patient-reported outcomes (PROs) instruments.","whoItsFor":["Ages 8 Years to any","Patient or their adult proxy must have verbal and written English language proficiency","Pathologically confirmed diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL); patients with evidence of transformed lymphoma at diagnosis or subsequent development of transformed lymphoma after diagnosis are eligible","Patients and/or adult proxy must be able to complete electronic quality of life surveys"],"whoShouldSkip":["Age 7 years or less","Patient or adult proxy does not have verbal and written English language proficiency","Patients with histologic evidence of a composite lymphoma (NLPHL with a concurrent diagnosis of Hodgkin lymphoma, indolent non-Hodgkin lymphoma, or gray zone lymphoma) at diagnosis are not eligible","Inability or unwillingness of research participant or legal guardian/representative to give consent"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.147Z"},{"nctId":"NCT06100744","title":"A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab","officialTitle":"Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.\n\nRisankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.\n\nParticipants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","conditions":["Juvenile Psoriatic Arthritis"],"keywords":["Juvenile Psoriatic Arthritis","Psoriatic Arthritis","Risankizumab","ABBV-066","Adalimumab"],"interventions":[{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Risankizumab"}],"enrollment":40,"startDate":"2024-07-08","completionDate":"2026-09","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening.\n* Active Disease in \\>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.\n* Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine.\n\nExclusion Criteria:\n\n* Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis \\[JIA\\], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.\n* Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.","locations":[{"facility":"Arkansas Children's Hospital /ID# 258776","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens National Medical Center /ID# 259284","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Joe Dimaggio Children's Hospital Hollywood /ID# 260634","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"All X Ray Diagnostic Services Corp /ID# 278523","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Riley Hospital for Children /ID# 259067","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M Health Fairview University of Minnesota Medical Center - West Bank /ID# 260111","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center /ID# 262587","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Childrens Health Physicians /ID# 258061","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina - Children's Hospital /ID# 259286","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MetroHealth Medical Center /ID# 262377","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic - Cleveland /ID# 276655","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Child Neurology Consultants of Austin /ID# 260562","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Health - Monash Medical Centre - Clayton /ID# 260255","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Children's Hospital /ID# 257880","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"British Columbia Children and Women's Hospital and Health Centre /ID# 257884","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital for Sick Children /ID# 257879","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu Bordeaux - Hopital Pellegrin /ID# 258729","city":"Bordeaux","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HP - Hopital Bicetre /ID# 258728","city":"Le Kremlin-Bicêtre","state":"Paris","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Klinik Sankt Augustin /ID# 259106","city":"Sankt Augustin","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helios Klinikum Berlin - Buch /ID# 268803","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 259104","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Meyer /ID# 258587","city":"Florence","state":"Firenze","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO /ID# 276753","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu /ID# 258869","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Malopolskie Badania Kliniczne /ID# 258777","city":"Cracow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Dzieciecy w Lublinie /ID# 258781","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. /ID# 277050","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu /ID# 277058","city":"Sosnowiec","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi /ID# 258785","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Deu /ID# 257568","city":"Esplugues de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario y Politecnico La Fe /ID# 257567","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital NHS Foundation Trust /ID# 258848","city":"Sheffield","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Bristol and Weston NHS Foundation Trust /ID# 258847","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alder Hey Children's NHS Foundation Trust /ID# 262770","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Percentage of Participants who Achieve >= 30% Improvement in Juvenile Idiopathic Arthritis American College of Rheumatology Response Criteria (JIA-ACR 30)","Number of Participants with Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab","risankizumab"],"locationSlugs":["little-rock-arkansas","washington-d-c-district-of-columbia","hollywood-florida","miami-florida","indianapolis-indiana","minneapolis-minnesota","new-york-new-york","valhalla-new-york","chapel-hill-north-carolina","cleveland-ohio","austin-texas","clayton-australia","calgary-canada","vancouver-canada","toronto-canada","bordeaux-france","le-kremlin-bic-tre-france","sankt-augustin-germany","berlin-germany","hamburg-germany","florence-italy","milan-italy","rome-italy","cracow-poland","lublin-poland","warsaw-poland","sosnowiec-poland","lodz-poland","esplugues-de-llobregat-spain","valencia-spain","sheffield-united-kingdom","bristol-united-kingdom","liverpool-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Adalimumab for Juvenile Psoriatic Arthritis","inPlainEnglish":"Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.","whoItsFor":["Ages 5 Years to 17 Years","Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening","Active Disease in \\>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study"],"whoShouldSkip":["Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab, or Risankizumab. The registry lists allocation as randomized. Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 40 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.268Z"},{"nctId":"NCT06102902","title":"Testing the Addition of Anti-cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment, Cetuximab Plus Encorafenib, for Colorectal Cancer","officialTitle":"A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E Metastatic Colorectal Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins. When ZEN003694 binds to BET proteins, it disrupts gene expression. Preventing the expression of certain growth-promoting genes may inhibit proliferation of tumor cells that over-express BET proteins. Immunotherapy with monoclonal antibodies, such as cetuximab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Encorafenib is an enzyme inhibitor. It inhibits pathways that are responsible for controlling cell proliferation and survival, which may lead to a decrease in tumor cell proliferation. Both cetuximab and encorafenib have been approved to treat cancer. Adding ZEN003694 to cetuximab and encorafenib may be more effective at treating patients with refractory metastatic colorectal cancer than giving the usual treatment (cetuximab and encorafenib) alone.","conditions":["Metastatic Colorectal Adenocarcinoma","Recurrent Colorectal Adenocarcinoma","Refractory Colorectal Adenocarcinoma","Stage IV Colorectal Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"DRUG","name":"BET Bromodomain Inhibitor ZEN-3694"},{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"BIOLOGICAL","name":"Cetuximab"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Encorafenib"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"}],"enrollment":30,"startDate":"2024-06-05","completionDate":"2027-01-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologically confirmed and radiographically measurable metastatic colorectal adenocarcinoma with known BRAF V600E mutation, confirmed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory with at least one tumor measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, and for which standard curative or palliative measures do not exist or are no longer effective\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with cetuximab and encorafenib in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,500/mcL\n* Platelets ≥ 100,000/mcL\n* Hemoglobin (Hb) ≥ 9 mg/dl\n* Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN)\n* Creatinine clearance (CrCL) glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Patients should be New York Heart Association Functional Classification of class II or better\n* Patients must have progressed after at least 1 prior systemic treatment for incurable advanced or metastatic disease\n* Patients must have received prior treatment with the combination of encorafenib and cetuximab. They must have tolerated the combination at doses planned for the study\n* For the dose expansion phase, patients must have discontinued encorafenib at least 2 weeks prior to starting study treatment\n* The effects of ZEN003694 on the developing human fetus are unknown. For this reason and because BRD and BET inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 4 months following the last dose of study drug. Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 72 hours prior to the start of investigational product. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents used in study\n* Patients with uncontrolled intercurrent illness including, but not limited to, active bleeding diatheses, poorly controlled infection/disorders, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy\n* Patients receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 or substrates of CYP1A2 with narrow therapeutic windows are ineligible. Strong inhibitors or inducers of CYP3A4 must be discontinued at least 7 days prior to the first dose of ZEN003694. As proton pump inhibitors (PPIs), H2 receptor antagonists, and antacids may alter the pharmacokinetics of ZEN003694 by reducing ZEN003694 exposure, patients receiving proton pump inhibitors are ineligible. If H2 blockers or other acid reducing agents are used concomitantly with ZEN003694, a staggered dosing schedule should be used, either dose ZEN003694 2 hours before the H2 blocker or 10-12 hours after an H2 blocker. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Pregnant women are excluded from this study because ZEN003694 is BRD and BET inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with ZEN003694, breastfeeding should be discontinued if the mother is treated with ZEN003694. These potential risks may also apply to other agents used in this study","locations":[{"facility":"UC Irvine Health Cancer Center-Newport","city":"Costa Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Clinical Research Center","city":"Fairway","state":"Kansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Cancer Center","city":"Kansas City","state":"Kansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Hospital-Indian Creek Campus","city":"Overland Park","state":"Kansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Hospital-Westwood Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Medical Center Jefferson","city":"New Orleans","state":"Louisiana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Maximum tolerated dose (dose escalation cohort)","Recommended phase 2 dose (dose escalation cohort)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["costa-mesa-california","irvine-california","los-angeles-california","orange-california","aurora-colorado","fairway-kansas","kansas-city-kansas","overland-park-kansas","westwood-kansas","new-orleans-louisiana","columbus-ohio","oklahoma-city-oklahoma","houston-texas","charlottesville-virginia","richmond-virginia"],"enrichment":{"headline":"Phase 1: testing BET Bromodomain Inhibitor ZEN-3694 for Metastatic Colorectal Adenocarcinoma","inPlainEnglish":"This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic). ZEN003694 is a protein inhibitor that binds to BET proteins.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of ZEN003694 in combination with cetuximab and encorafenib in patients \\< 18 years of age, children are excluded from this study","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)","Absolute neutrophil count ≥ 1,500/mcL","Platelets ≥ 100,000/mcL","Hemoglobin (Hb) ≥ 9 mg/dl","Total bilirubin ≤ 1.5 mg/dl (excluding Gilbert's disease)","Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional upper limit of normal (ULN)"],"whoShouldSkip":["Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia","Patients who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to ZEN003694 or other agents used in study","Patients with uncontrolled intercurrent illness including, but not limited to, active bleeding diatheses, poorly controlled infection/disorders, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy"],"whatHappens":"If you join, the listed intervention(s) are BET Bromodomain Inhibitor ZEN-3694, Biopsy Procedure, or Biospecimen Collection. The registry lists allocation as na. This phase I trial tests the safety, best dose, and effectiveness of ZEN003694 in combination with cetuximab and encorafenib in treating patients with colorectal cancer that has not responded to previous treatment (refractory), that has come back after a period of improvement (relapsed), and that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 16 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.070Z"},{"nctId":"NCT06103760","title":"Positioning of Esketamine Treatment in the Real-world Management of Depression","officialTitle":"Positioning of Esketamine Treatment in the Real-world Management of Depression","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Royal North Shore Hospital","sponsorClass":"OTHER","summary":"The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are:\n\n* to investigate whether Esketamine is effective when added to ongoing antidepressant treatment\n* to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice\n\nParticipants will:\n\n* attend the clinic for supervised self-administration of intranasal Esketamine treatment\n* be observed for 2 hours following Esketamine administration including blood pressure monitoring\n* be asked to complete a battery of questionnaires\n* be reimbursed for travel expenses","conditions":["Major Depressive Disorder"],"keywords":["Depression"],"interventions":[{"type":"DRUG","name":"Esketamine Nasal Spray [Spravato]"}],"enrollment":162,"startDate":"2023-10-31","completionDate":"2027-12-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 18-65 years old\n2. Diagnosis of Major Depressive Disorder (MDD)\n3. Currently depressed\n4. Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)\n5. Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment\n6. Able to understand and provide informed consent\n\nExclusion Criteria:\n\n1. Concurrent diagnoses:\n\n   * Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia\n   * Participants who are unable to understand the study and therefore unable to provide informed consent\n2. Pregnancy:\n\n   * Participants who are pregnant and/or breastfeeding\n   * Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods\n3. Current medications:\n\n   * Participants taking a total daily dose of benzodiazepines greater than the equivalent of 6mg/day of lorazepam\n   * Participants on complementary and alternative medicine therapies i.e., St John's wort, Chinese medicines, and various herbal and homeopathic treatments\n4. Stimulants\n\n   * Participants taking stimulants such as methylphenidate, amphetamine, and dextroamphetamine for a diagnosis such as ADHD can still have Esketamine provided they do not continue taking stimulants concurrently for the duration of the study.\n   * Concurrent use is excluded due to the synergistic effect with Esketamine that can cause increased blood pressure.\n5. Medical history:\n\n   * Participants with current or past history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)\n   * Participants with a history of uncontrolled hypertension\n   * Participants with uncontrolled diabetes mellitus\n   * Participants with aneurysmal vascular disease including thoracic and abdominal aorta, intracranial and peripheral arterial vessels, or arteriovenous malformation, intracerebral haemorrhage\n   * Participants with untreated glaucoma, current penetrating or perforating eye injury, brain injury, hypertensive encephalopathy, intrathecal therapy with ventricular shunts, or any other condition associated with increased intracranial pressure or increased intraocular pressure or planned eye surgery\n   * Participants who are currently receiving electroconvulsive therapy (ECT) or have received ECT in the past month.\n6. Substance Misuse History:\n\n   * Participants who have ever had a substance misuse disorder involving any of the following over their lifetime: ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3,4-methylenedioxy-methamphetamine (MDMA), or other hallucinogen use history\n   * Participants with hypersensitivity to Esketamine, Ketamine, or any of the excipients","locations":[{"facility":"Royal North Shore Hospital","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erica Bell","phone":"02 9462 9905","email":"NSLHD-researchpoet@health.nsw.gov.au"},{"name":"Yan Yau Wong","phone":"","email":"NSLHD-researchpoet@health.nsw.gov.au"}],"primaryOutcomes":["Percentage of treatment responders determined by a 50% reduction on the Hamilton Depression Rating Scale (HAM-D) 17-Item scoring.","Mean depression score on the Quick Inventory of Depressive Symptomatology Self-report (QIDS-SR) 16-Item.","Global functioning determined by Clinical Global Impression (CGI) score."],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["st-leonards-australia"],"enrichment":{"headline":"Phase 4: testing Esketamine Nasal Spray [Spravato] for Major Depressive Disorder","inPlainEnglish":"The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to see if Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses","whoItsFor":["Ages 18 Years to 65 Years","Adults aged 18-65 years old","Diagnosis of Major Depressive Disorder (major depression)","Currently depressed","Had an inadequate response to 2 or more courses of antidepressants (of adequate dose and duration)","Be maintained on their current antidepressant medication or psychological therapy at the time of enmrolment"],"whoShouldSkip":["Concurrent diagnoses:","Participants with other 'Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) e.g., current substance misuse disorder, bipolar disorder, schizophrenia","Participants who are pregnant and/or breastfeeding","Participants who are not willing to avoid pregnancy for themselves or their partners during the study by using effective birth control methods","Current medications:","Participants taking a total daily dose of benzodiazepines greater than the equivalent of 6mg/day of lorazepam","Participants on complementary and alternative medicine therapies i.e., St John's wort, Chinese medicines, and various herbal and homeopathic treatments"],"whatHappens":"If you join, the listed intervention(s) are Esketamine Nasal Spray [Spravato]. The registry lists allocation as na. The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: * to see if Esketamine is effective when added to ongoing antidepressant treatment * to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: * attend the clinic for supervised self-administration of intranasal Esketamine treatment * be observed for 2 hours following Esketamine administration including blood pressure monitoring * be asked to complete a battery of questionnaires * be reimbursed for travel expenses","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 162 people at St Leonards. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.792Z"},{"nctId":"NCT06103838","title":"18F-Fluciclovine PET/CT in Multiple Myeloma","officialTitle":"A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nMultiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier.\n\nObjective:\n\nTo find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose.\n\nEligibility:\n\nAdults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM).\n\nDesign:\n\nParticipants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body.\n\nAll participants will have 3 study visits. During each visit they will have:\n\nTwo PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine.\n\nAn optional magnetic resonance imaging scan.\n\nA bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone.\n\nThese tests may be spread over 30 days for each visit.\n\nNDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first.\n\nAll participants will have a third study visit after 5 years or when their disease progresses....","conditions":["Multiple Myeloma","Newly Diagnosed Multiple Myeloma (NDMM)","Relapsed and/or Refractory Multiple Myeloma (RRMM)"],"keywords":["RRMM","NDMM","18F-FDG PET/CT","PET/CT","18F-fluciclovine","Imaging","Multiple Myeloma"],"interventions":[{"type":"DRUG","name":"18F-fluciclovine injection"},{"type":"PROCEDURE","name":"18F-FDG PET/CT"}],"enrollment":60,"startDate":"2024-03-25","completionDate":"2027-12-06","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g/dL and/or bone marrow plasma cells \\>= 10% and at least one of the following:\n\n  * Anemia: Hemoglobin \\<=10 g/dL, or\n  * Renal Failure: serum creatinine \\>= 2.0 mg/dL, or\n  * Hypercalcemia: Ca \\>= 10.5 mg/dL, or\n  * Lytic bone lesions on X-ray, CT, or PET/CT, or\n  * \\>= 2 focal lesions on spinal MRI, or\n  * \\>= 60% bone marrow plasma cells, or\n  * Involved/un-involved serum free light chain ration \\>= 100\n* Participants must have measurable disease defined by any one of the following:\n\n  * Monoclonal bone marrow plasma cells \\> 5%\n  * Serum monoclonal protein \\>= 0.2 g/dl\n  * Urine monoclonal protein \\> 200 mg/24 hr\n  * Serum immunoglobulin free light chain \\> 10 mg/dL AND abnormal kappa/lambda ratio\n  * A measurable lesion on PET/CT or MRI\n* Participants fit criteria for one of the following categories:\n\n  * Newly diagnosed multiple myeloma (NDMM)\n  * Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy\n* Age \\>=18 years.\n* ECOG performance status \\<= 2\n* Negative serum or urine pregnancy test at screening for WOCBP.\n* Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.\n* Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.\n* Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.\n* Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Medical Oncology Referral Office","phone":"(240) 760-6050","email":"ncimo_referrals@nih.gov"},{"name":"Elizabeth M Hill, M.D.","phone":"(240) 889-5377","email":"elizabeth.hill@nih.gov"}],"primaryOutcomes":["To determine the concordance between 18F-fluciclovine PET/CT and 18F-FDG PET/CT in participants with multiple myeloma."],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing 18F-fluciclovine injection for Multiple Myeloma","inPlainEnglish":"Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis.","whoItsFor":["Ages 18 Years to 120 Years","Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein \\>= 3 g/dL and/or bone marrow plasma cells \\>= 10% and at least one of the following:","Anemia: Hemoglobin \\<=10 g/dL, or","Renal Failure: serum creatinine \\>= 2.0 mg/dL, or","Hypercalcemia: Ca \\>= 10.5 mg/dL, or","Lytic bone lesions on X-ray, CT, or PET/CT, or","\\>= 2 focal lesions on spinal MRI, or","\\>= 60% bone marrow plasma cells, or"],"whoShouldSkip":["History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG","Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them","Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements","Because there is an unknown but potential risk for side effects in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine"],"whatHappens":"If you join, the listed intervention(s) are 18F-fluciclovine injection, or 18F-FDG PET/CT. The registry lists allocation as na. Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.478Z"},{"nctId":"NCT06108336","title":"Cerebellar Involvement in Cognitive Sequencing","officialTitle":"Investigation of Cerebellar Involvement in Cognitive Sequencing","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"Although there is increasing recognition that the cerebellum is involved in cognition as well as motor function, the manner in which the cerebellum contributes to cognition is uncertain. One theory that might account for both motor and cognitive contributions of the cerebellum is that the cerebellum is involved in sequencing of relevant events or stimuli. Previous experiments have suggested that disruption of the cerebellum impairs the prediction of the next event in a sequence. The present experiment will examine the impact of cerebellar stimulation on brain activation during the performance of both sequence-demanding and non-sequence-demanding tasks.","conditions":["Effects of Cerebellar Stimulation on Brain Activation"],"keywords":["sequencing","cerebellum","transcranial magnetic stimulation","TMS","functional MRI","fMRI","verbal working memory"],"interventions":[{"type":"PROCEDURE","name":"TMS during sequence-demanding task"},{"type":"PROCEDURE","name":"No TMS during sequence-demanding task"},{"type":"PROCEDURE","name":"TMS during non-sequence-demanding task"},{"type":"PROCEDURE","name":"No TMS during non-sequence-demanding task"}],"enrollment":50,"startDate":"2024-03-01","completionDate":"2026-12-30","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\) Age 18-50;\n* 2\\) educational attainment of at least 8 years;\n* 3\\) capable of giving informed consent;\n* 4\\) fluent speaker of English by self-report;\n* 5\\) right handed.\n\nExclusion Criteria:\n\n* 1\\) illicit drug use within 30 days of MRI scanning;\n* 2\\) neurological or systemic disorder which can cause dementia or cognitive dysfunction;\n* 3\\) history of an Axis I psychiatric disorder including substance use disorder;\n* 4\\) history of definite stroke;\n* 5\\) focal lesion on MRI exam;\n* 6\\) uncorrected visual deficits by self-report\n* 7\\) contraindications for MRI scanning\n* 8\\) use of anxiolytic, antidepressant, neuroleptic, or sedative medication\n* 9\\) Additional exclusion criteria recommended by Wassermann for TMS neuromodulation, including: History of seizure or a family history of epilepsy, heart disease, intracardiac lines, increased intracranial pressure, history of head trauma, and history of respiratory disease","locations":[{"facility":"Johns Hopkins University School of Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"John E Desmond, Ph.D.","phone":"410-502-3583","email":"jdesmon2@jhmi.edu"},{"name":"JoAnna Mathena, MS","phone":"443-571-0947","email":"labnim@jh.edu"}],"primaryOutcomes":["functional magnetic resonance imaging brain activation"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: TMS during sequence-demanding task for Effects of Cerebellar Stimulation on Brain Activation","inPlainEnglish":"Although there is increasing recognition that the cerebellum is involved in cognition as well as motor function, the manner in which the cerebellum contributes to cognition is uncertain. One theory that might account for both motor and cognitive contributions of the cerebellum is that the cerebellum is involved in sequencing of relevant events or stimuli.","whoItsFor":["Ages 18 Years to 50 Years","2\\) educational attainment of at least 8 years;","4\\) fluent speaker of English by self-report;"],"whoShouldSkip":["1\\) illicit drug use within 30 days of MRI scanning;","2\\) neurological or systemic disorder which can cause dementia or cognitive dysfunction;","3\\) history of an Axis I psychiatric disorder including substance use disorder;","4\\) history of definite stroke;","5\\) focal lesion on MRI exam;","6\\) uncorrected visual deficits by self-report","7\\) contraindications for MRI scanning"],"whatHappens":"If you join, the listed intervention(s) are TMS during sequence-demanding task, No TMS during sequence-demanding task, or TMS during non-sequence-demanding task. The registry lists allocation as randomized. Although there is increasing recognition that the cerebellum is involved in cognition as well as motor function, the manner in which the cerebellum contributes to cognition is uncertain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Baltimore. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.248Z"},{"nctId":"NCT06110130","title":"Effect of Empagliflozin on Podocyte Specific Proteins in African American Veterans With NDKD","officialTitle":"Effect of Empagliflozin on Podocyte Specific Proteins (Injury Markers) in African American Veterans With Non-Diabetic Chronic Kidney Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Washington D.C. Veterans Affairs Medical Center","sponsorClass":"FED","summary":"Primary Objective:\n\nTo study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease (NDKD), on empagliflozin therapy.\n\nPrimary Endpoint: We will assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein.\n\nSecondary Objectives:\n\n1. Correlate changes in exosome-based podocyte specific proteins with standardized biomarkers of kidney injury including urine albumin/creatinine ratio (ACR) and estimated GFR.\n2. Correlate systemic inflammatory markers (focusing on vascular and endothelial function) that are already established such as interleukins (IL1, IL6, IL-12) , hs-CRP and arterial stiffness measures with urine exosome-based podocyte protein estimation \\[11, 27-29\\].\n3. Correlate urine podocyte-specific protein markers with APOL1 mRNA expression levels in blood mononuclear cells (MNC)","conditions":["Chronic Kidney Diseases"],"keywords":["Non-diabetic"],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2024-02-02","completionDate":"2027-12-01","sex":"ALL","minAge":"19 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. African American veterans\n2. Age \\> 18 years\n3. eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR\n4. eGFR 60-89, with UACR of ≥30mg/g\n5. BMI = 18-39.9\n6. Blood pressure controlled to ≤140/90\n7. Subjects without diabetes: will be screened using routine glucose level test: of less than 126 fasting glucose or less than 200mg/dl of random or post glucose blood glucose level in standard of care laboratory workup.\n8. Ability to provide informed consent before any trial related activities are conducted.\n\nExclusion Criteria:\n\n1. Diagnosed with Type 1 or Type 2 Diabetes Mellitus\n2. Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas\n3. If a patient is on statin, need to be on a stable dose for a month.\n4. Biopsy proven diagnosis of glomerular disease/glomerulonephritis\n5. Active smokers,\n6. Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)\n7. Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure\n8. Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema\n9. Patients on dialysis\n10. eGFR less than 20 mL/min/1.73 m2 by the CKD-EPI equation\n11. Planned surgery or planned hospital admission within 5 months of participation in the study\n12. At the discretion of PI to ensure health, safety, and well-being of the veteran, participation in this study may be stopped (please see withdrawal criteria)\n13. Patients with prior history of diagnosis of heart failure with documented EF of less than 50.\n14. Proven diagnosis of Polycystic Kidney Disease.","locations":[{"facility":"Washington DC Veterans Affairs Medical Center (688)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sabyasachi Sen, MD","phone":"202-745-8000","email":"sabyasachi.sen@va.gov"},{"name":"Shannen Ubalde, BS","phone":"202-745-8000","email":"shannen.ubalde@va.gov"}],"primaryOutcomes":["To study kidney dysfunction and podocyte specific injury"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":["empagliflozin"],"locationSlugs":["washington-d-c-district-of-columbia"],"enrichment":{"headline":"Phase 4: testing Empagliflozin 10 MG for Chronic Kidney Diseases","inPlainEnglish":"Primary Objective: To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease (NDKD), on empagliflozin therapy. Primary Endpoint: We will assess the effect of Empagliflozin on podocyte-specific proteins in exosomes isolated from subjects' urine, such as nephrin, podocalyxin and Wilms'Tumor (WT-1) protein.","whoItsFor":["Ages 19 Years to 90 Years","African American veterans","eGFR ≥20-59 mL/min/1.73 m2 by the CKD-EPI equation, with or without any degree of albuminuria OR","eGFR 60-89, with UACR of ≥30mg/g","Blood pressure controlled to ≤140/90","Subjects without diabetes: will be screened using routine glucose level test: of less than 126 fasting glucose or less than 200mg/dl of random or post glucose blood glucose level in standard of care laboratory workup"],"whoShouldSkip":["Diagnosed with Type 1 or Type 2 Diabetes Mellitus","Any prescribed diabetes medication for patients, such as GLP1RA, SGLT2is, and sulphonylureas","If a patient is on statin, need to be on a stable dose for a month","Biopsy proven diagnosis of glomerular disease/glomerulonephritis","Active skin wounds undergoing treatment or recent surgery within 1 month (due to possible aberrations in glycemic control)","Women who are pregnant, planning to become pregnant, nursing mothers, women of childbearing potential not using birth control measure","Hypersensitivity to empagliflozin or any of the excipients in Jardiance, reactions such as angioedema"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG, or Placebo. The registry lists allocation as randomized. Primary Objective: To study podocyte specific injury markers in African American Veterans with non-diabetic kidney disease (NDKD), on empagliflozin therapy.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 60 people at Washington D.C.. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.620Z"},{"nctId":"NCT06123741","title":"Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.","officialTitle":"Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merja Nikula","sponsorClass":"OTHER","summary":"Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.\n\nThe major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.\n\nResearchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.","conditions":["Attention Deficit Hyperactivity Disorder"],"keywords":["Attention Deficit Hyperactivity Disorder","Attention","Executive Function","Virtual Reality","Child"],"interventions":[{"type":"BEHAVIORAL","name":"Parental Guidance"},{"type":"BEHAVIORAL","name":"Virtual Reality Game"}],"enrollment":88,"startDate":"2024-01-10","completionDate":"2027-12-31","sex":"ALL","minAge":"8 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of ADHD (ICD-10 F90.0) and\n* Methylphenidate medication and\n* Age 8-12 years and\n* Finnish as a native language\n\nExclusion Criteria:\n\n* Sensitivity to flashing light,\n* Epilepsy (ICD-10 G40),\n* Mental retardation (ICD-10 F70-F79),\n* Pervasive developmental disorders (ICD-10 F84),\n* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),\n* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),\n* Traumatic brain injury ((ICD-10 S06),\n* Brain tumour, and\n* Multiple pregnancy","locations":[{"facility":"Oulu University Hospital","city":"Oulu","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Merja Nikula, M.Psych.","phone":"+3588315 5218","email":"merja.nikula@pohde.fi"},{"name":"Johanna Uusimaa, MD, PhD","phone":"","email":"johanna.uusimaa@pohde.fi"}],"primaryOutcomes":["Epeli (Executive Performance in Everyday LIving) task","ADHD-rating scale IV (ADHD-RS) (parent report)","Epeli Questionnaire (parent report)","Epeli Questionnaire (child report)"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["oulu-finland"],"enrichment":{"headline":"Not a traditional drug phase: Parental Guidance for Attention Deficit Hyperactivity Disorder","inPlainEnglish":"Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity.","whoItsFor":["Ages 8 Years to 12 Years","Diagnosis of ADHD (ICD-10 F90.0) and","Methylphenidate medication and","Finnish as a native language"],"whoShouldSkip":["Sensitivity to flashing light,","Epilepsy (ICD-10 G40),","Mental retardation (ICD-10 F70-F79),","Pervasive developmental disorders (ICD-10 F84),","Inflammatory diseases of the central nervous system (ICD-10 G00-G09),","Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),","Traumatic brain injury ((ICD-10 S06),"],"whatHappens":"If you join, the listed intervention(s) are Parental Guidance, or Virtual Reality Game. The registry lists allocation as randomized. Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 88 people at Oulu. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.646Z"},{"nctId":"NCT06125743","title":"Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]","officialTitle":"Promoting Self-Management in Head and Neck Cancer Survivors With Lymphedema and Fibrosis [PROMISE Trial]","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Abramson Cancer Center at Penn Medicine","sponsorClass":"OTHER","summary":"The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.","conditions":["Lymphedema of the Head and Neck"],"keywords":["Lymphedema","Fibrosis","Head and Neck Cancer","Survivorship","Self-Management"],"interventions":[{"type":"BEHAVIORAL","name":"Usual Care"},{"type":"BEHAVIORAL","name":"In-Person LEF-SMP"},{"type":"BEHAVIORAL","name":"Telehealth LEF-SMP"}],"enrollment":204,"startDate":"2024-03-29","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \\>18 years of age\n* Post HNC primary treatment\n* No evidence of cancer (NED)\n* Completion of initial lymphedema therapy for head and neck lymphedema\n* Unable to obtain lymphedema therapy due to barriers noted above\n* History of lymphedema on the face and neck, with or without fibrosis\n* Ability to understand English in order to complete questionnaires\n* Ability to perform self-care activities for LEF management\n* Ability to provide informed consent\n* Having an electronic device (a computer, tablet, iPad, or smartphone) and internet access at home\n* A valid email address\n\nExclusion Criteria:\n\n* Recurrent or metastatic cancer\n* Any other active cancer\n* Acute infection\n* Acute congestive heart failure\n* Acute renal failure\n* Cardiac or pulmonary edema\n* Sensitive carotid sinus\n* Severe carotid blockage\n* Uncontrolled hypertension\n* Venous thrombosis\n* Pregnant people\n* Incarcerated patients","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jie Deng, PhD","phone":"2155732393","email":"jiedeng@nursing.upenn.edu"}],"primaryOutcomes":["Changes in severity of lymphedema and fibrosis"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania","nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: Usual Care for Lymphedema of the Head and Neck","inPlainEnglish":"The goal of this study is to measure the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.","whoItsFor":["Ages 18 Years to any","Post HNC primary treatment","No evidence of cancer (NED)","Completion of initial lymphedema therapy for head and neck lymphedema","Unable to obtain lymphedema therapy due to barriers noted above","History of lymphedema on the face and neck, with or without fibrosis","Ability to understand English in order to complete questionnaires","Ability to perform self-care activities for LEF management"],"whoShouldSkip":["Recurrent or metastatic cancer","Any other active cancer","Acute congestive heart failure","Acute renal failure","Cardiac or pulmonary edema","Sensitive carotid sinus","Severe carotid blockage"],"whatHappens":"If you join, the listed intervention(s) are Usual Care, In-Person LEF-SMP, or Telehealth LEF-SMP. The registry lists allocation as randomized. The goal of this study is to measure the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 204 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.328Z"},{"nctId":"NCT06126276","title":"Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)","officialTitle":"A Randomized Trial of Neratinib, A Pan-ERBB Inhibitor, Alone or in Combination With Palbociclib, a CDK4/6 Inhibitor, in Patients With HER2+ Gynecologic Cancers and Other Solid Tumors: A ComboMATCH Treatment Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.","conditions":["Malignant Female Reproductive System Neoplasm","Malignant Solid Neoplasm","Recurrent Malignant Female Reproductive System Neoplasm","Recurrent Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Neratinib Maleate"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":70,"startDate":"2024-05-07","completionDate":"2027-02-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191\n* Patients must have a HER2 amplified solid tumor except breast cancer.\n\n  * If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status\n  * If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status\n  * If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE\n  * If IHC is unknown and…\n\n    * ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE\n    * ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE\n* Patients must have recurrent or persistent disease\n* No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation\n* Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)\n* Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic\n* No known leptomeningeal disease\n* Patients may have received up to 5 prior lines of systemic therapy\n* Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed\n* No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib\n* No prior therapy with CDK4/6 inhibition\n* No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n* Platelets ≥ 100,000 cells/mm\\^3\n* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula\n* Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube\n* No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy\n* No lung disease causing dyspnea at rest\n* No interstitial lung disease with ongoing signs and symptoms at the time of registration\n* No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Alabama Mitchell Cancer Institute","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health System - Encinitas","city":"Encinitas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute - West Los Angeles Office","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Miller School of Medicine-Sylvester Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Kendall","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Sylvester Comprehensive Cancer Center at Sole Mia","city":"North Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UM Sylvester Comprehensive Cancer Center at Plantation","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Cancer Care Center-Boise","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute - 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Nampa","city":"Nampa","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SIH Cancer Institute","city":"Carterville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John H Stroger Jr Hospital of Cook County","city":"Chicago","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"University of Illinois","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University HealthSystem-Highland Park Hospital","city":"Highland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercyhealth Cancer Institute - Rockford","city":"Rockford","state":"Illinois","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Des Moines Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Laurel Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Waukee Clinic","city":"Waukee","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CommonSpirit Saint Joseph Medical Center - East Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky/Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harold Alfond Center for Cancer Care","city":"Augusta","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lafayette Family Cancer Center-EMMC","city":"Brewer","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MaineHealth Maine Medical Center- Scarborough","city":"Scarborough","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland/Greenebaum Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Walter Reed National Military Medical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Western 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States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"OSF Saint Francis Hospital and Medical Group","city":"Escanaba","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health Farmington Hills Hospital","city":"Farmington Hills","state":"Michigan","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Cancer Hematology Centers - Flint","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genesee Hematology Oncology PC","city":"Flint","state":"Michigan","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Genesys Hurley Cancer Institute","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hurley Medical Center","city":"Flint","state":"Michigan","country":"United 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2: testing Neratinib Maleate for Malignant Female Reproductive System Neoplasm","inPlainEnglish":"This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors.","whoItsFor":["Ages 18 Years to any","Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191","Patients must have a HER2 amplified solid tumor except breast cancer","If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status","If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status","If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE","If IHC is unknown and…","ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at 194 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.710Z"},{"nctId":"NCT06126315","title":"Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS","officialTitle":"A Randomized, Phase II/III Trial on the Biological and Clinical Effects of Acetyl-L-carnitine in ALS","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Mario Negri Institute for Pharmacological Research","sponsorClass":"OTHER","summary":"Phase II/III multicenter, randomized, double-blind, placebo-controlled trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the efficacy of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale. Secondary study aims: 1. The effect of ALCAR treatment on different clinical aspects: functional decline as measured by ALSFRS-R total score; the decline of forced vital capacity (FVC); quality of life as measured by ALSAQ-40 scale; cognitive function as measured by Edinburgh Cognitive and Behavioural ALS Screen (ECAS) scale; survival (being alive and without tracheostomy). 2. To measure the effects of ALCAR treatment on disease biomarkers potentially involved in the drug's mechanisms of action. These include PGC-1 alpha, 3-nitrotyrosine (3-NT), acetyl cyclophilin A (acetyl-PPIA), neurofilament light chain (NFL), creatine kinase (CK), Musclin/osteocrin, MyomiRNA (MiR-206), Uric acid, Matrix metalloproteinase-9 (MMP-9), Monocyte Chemoattractant Protein-1 (MCP-1), 4-Hydroxynonenal (HNE). 3. The tolerability and safety of ALCAR treatment by identifying unexpected adverse events.\n\nStudy population: 246 subjects will be enrolled on one Australian and ten Italian ALS sites.\n\nInclusion criteria: subjects aged 18+ years with a diagnosis of ALS according to Gold Coast Criteria; disease duration \\<24 months; satisfactory bulbar and spinal function (self-sufficiency evaluated by a score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking); satisfactory respiratory function (FVC ≥80% of predicted); documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\\>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening, treatment with Riluzole in the last four weeks. Exclusion criteria: antecedent polio infection; other motor neuron disease; involvement of other systems possibly determining a functional impairment; other severe clinical conditions; unwillingness or inability to take riluzole; previous use of ALCAR for any reason; inability to understand and comply with the study requirements, and to give written informed consent personally or via their legally authorized representative.\n\nAll eligible participants will be randomized to receive ALCAR (1,5 or 3 g/day) or placebo in addition to riluzole 50 mg b.i.d. Permuted block (with a block size of 6), 1:1:1 centralized randomization scheme will be used. The overall treatment duration will be 48 weeks. After enrolment, each participant will be followed up until death. Eligible subjects will be seen after 4, 12, 24, 36 and 48 weeks. At each visit, a general assessment will be made, including vital signs, body mass index (BMI), neurological examination (including quantitative and qualitative evaluation of the motor system), comorbidity, concomitant treatments and adverse events. Blood samples will be collected at baseline -Day 1 (randomization)-, 4, 12, 24, 36 and 48 weeks to test biomarkers. Functional disability will be assessed at each visit using the ALS-FRS-R scale. The respiratory function will be assessed using a spirometer to measure FVC before starting treatment (baseline visit) and at 4, 12, 24, 36 and 48 weeks. Cognitive function will be evaluated at baseline, weeks 24 and 48, using ECAS scale. Health-related quality of life, measured by the ALSAQ-40, will be tested at baseline, 24 and 48 weeks. Compliance will be tested by the local investigators, counting unused packages at each follow-up visit. Pre-planned statistical analyses will be done on Intention-to-treat and Per-protocol (PP) populations. The statistical plan will include descriptive statistics and a comparison of the proportions of self-sufficient participants at week 48 using the chi-square or Fisher's exact test for the primary endpoint. Secondary endpoints measured by numerical scores obtained from clinical scales will be analyzed using repeated measures mixed models, while biomarkers using repeated measures ANOVA. Time-to-event endpoints, such as survival and the probability of remaining self-sufficient over 48 weeks, will be analyzed with Kaplan-Meier curves. The number of adverse events and serious adverse events after 48 weeks will be compared between treatment arms.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Acetyl-l-carnitine"},{"type":"DRUG","name":"Placebo"}],"enrollment":246,"startDate":"2025-03-26","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18+;\n2. ALS diagnosis according to the Gold Coast Criteria;\n3. Disease duration \\< 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit\\*;\n4. Self-sufficiency \\[Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)\\];\n5. Satisfactory respiratory function (FVC ≥80% of predicted);\n6. Documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\\>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening.\n7. Ability to understand and comply with the study requirements;\n8. Ability to give written informed consent personally or, as an alternative, via a legally authorized representative;\n9. Treatment with riluzole 50 mg twice/day for at least 4 weeks prior to randomization visit;\n10. Intact cognitive function, again determined by the Principal Investigator.\n\n    * The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles. Cramps, fasciculations, or fatigue should not be taken in isolation as a first symptom of ALS.\n\nExclusion Criteria:\n\n1. Antecedent polio infection or other active infection;\n2. Motor neuron disease (MND) other than ALS;\n3. Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study;\n4. Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months;\n5. Previous use of ALCAR for any reason;\n6. Poor compliance with previous treatments;\n7. Other experimental treatments in the three months prior to the screening visit (if a subject is receiving another experimental drug, a 3-month wash-out period before participating in the present clinical trial will be required);\n8. Women who are lactating or able to become pregnant (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control) and men unable to practice contraception for the duration of the treatment and three months after its completion;\n9. Inability to understand and comply with the study requirements;\n10. Unwillingness or inability to take riluzole.","locations":[{"facility":"Concord Hospital","city":"Sydney","state":"Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Serena ONLUS Centro Clinico NEMO Brescia","city":"Brescia","state":"Brescia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Dipartimento di Neurologia","city":"Bergamo","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Auxologico Italiano, IRCCS Dipartimento di Neurologia","city":"Milan","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II Di Napoli","city":"Naples","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria \"Luigi Vanvitelli\", Dipartimento di Scienze mediche e chirurgiche avanzate","city":"Naples","state":"Italy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria Maggiore della Carità","city":"Novara","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedale-Università di Padova, Unità di Neurologia Clinica","city":"Padova","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.S.P. Palermo, Villa delle Ginestre Hospital","city":"Palermo","state":"Italy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Serena ONLUS-Centro Clinico NEMO Trento","city":"Pergine Valsugana","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera di Perugia","city":"Perugia","state":"Italy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Pisana, Dipartimento di Medicina Clinica e Sperimentale","city":"Pisa","state":"Italy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"San Camillo Forlanini Hospital, Center for Neuromuscolar and Neurological Rare Diseases, Unit of Neurology and Neurophysiopathology","city":"Roma","state":"Italy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Serena ONLUS - Centro Clinico NeMO Ancona","city":"Torrette","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Serena ONLUS centro clinico NEMO","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU di Modena Nuovo Ospedale Civile S. Agostino Estense di Modena - Ospedale di Baggiovara","city":"Modena","state":"Modena","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico IRCCS","city":"Pavia","state":"Pavia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Pisana","city":"Pisa","state":"Pisa","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria Policlinico Umberto I - Università di Roma \"La Sapienza\"","city":"Roma","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elisabetta Pupillo, PharmD","phone":"00390239014605","email":"elisabetta.pupillo@marionegri.it"}],"primaryOutcomes":["self-sufficient"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["sydney-australia","brescia-italy","bergamo-italy","milan-italy","naples-italy","novara-italy","padova-italy","palermo-italy","pergine-valsugana-italy","perugia-italy","pisa-italy","roma-italy","torrette-italy","modena-italy","pavia-italy"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Acetyl-l-carnitine for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Phase II/III multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS). Primary study aim: The clinical objective consists of assessing the how well it works of ALCAR (two different dosages will be tested: 1.5g/day and 3g/day) on the progression of functional disability (loss of self-sufficiency), as measured by the ALSFRS-R scale.","whoItsFor":["Ages 18 Years to any","ALS diagnosis according to the Gold Coast Criteria;","Disease duration \\< 24 months from symptom onset, as indicated by limb weakness or bulbar symptoms, at the randomization/baseline visit\\*;","Self-sufficiency \\[Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for swallowing, cutting food and handling utensils, and walking)\\];","Satisfactory respiratory function (FVC ≥80% of predicted);","Documented progression of symptoms as measured by the ALSFRS-R scale. Disease progression rate (DFS) must be\\>= 0.33. DFS =(48- ALSFRS-R at screening)/months from onset to screening","Ability to understand and comply with the study requirements;","Treatment with riluzole 50 mg twice/day for at least 4 weeks prior to randomization visit;"],"whoShouldSkip":["Antecedent polio infection or other active infection;","Motor neuron disease (MND) other than ALS;","Involvement of other systems possibly determining a functional impairment (as measured by the endpoints) for the entire duration of the study;","Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with an impact on survival or functional disability in the next 12 months;","Previous use of ALCAR for any reason;","Poor compliance with previous treatments;","Other experimental treatments in the three months prior to the screening visit (if a subject is receiving another experimental drug, a 3-month wash-out period before participating in the present clinical trial will be required);"],"whatHappens":"If you join, the listed intervention(s) are Acetyl-l-carnitine, or Placebo. The registry lists allocation as randomized. Phase II/III multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial on acetyl-L-carnitine (ALCAR) in subjects living with amyotrophic lateral sclerosis (ALS).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 246 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.617Z"},{"nctId":"NCT06127342","title":"Exercise and Emotional Learning in Posttraumatic Stress Disorder","officialTitle":"Exercise and Emotional Learning in Posttraumatic Stress Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Christal L Badour","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions. During the first experimental session, participants will undergo an MRI session of imaginal exposure to traumatic memory cues followed by 30-minutes of moderate intensity exercise or low intensity exercise. Participants will complete a second session of imaginal exposure with MRI 24 hours later.","conditions":["PTSD"],"keywords":["Interpersonal Violence","Exercise"],"interventions":[{"type":"BEHAVIORAL","name":"Moderate Intensity Exercise"},{"type":"BEHAVIORAL","name":"Low Intensity Exercise"}],"enrollment":100,"startDate":"2024-05-13","completionDate":"2026-10-30","sex":"ALL","minAge":"18 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults with PTSD related to interpersonal violence\n\nExclusion Criteria:\n\n* Active or recent (within the last 3 months) severe substance use disorder(s)\n* Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes\n* Significant developmental disabilities\n* Current daily benzodiazepine or stimulant use with inability to abstain for study sessions\n* Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)\n* Medical condition(s) that prohibit exercise\n* History of traumatic brain injury (TBI) with loss of consciousness \\> 30 mins\n* Magnetic resonance imaging (MRI) contraindication(s)\n* Positive pregnancy test\n* History of seizure disorder\n* Spontaneous seizure(s) within the last 3 months","locations":[{"facility":"University of Kentucky","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christal G Badour, PhD","phone":"859-323-3817","email":"christal.badour@uky.edu"}],"primaryOutcomes":["Change in participant subjective emotional ratings","Change in Heart Rate","Change in Fear Circuit Blood Oxygen Level-Dependent (BOLD) Response"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["lexington-kentucky","austin-texas"],"enrichment":{"headline":"Not a traditional drug phase: Moderate Intensity Exercise for PTSD","inPlainEnglish":"The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD. Participants will complete a baseline intake followed by two experimental sessions.","whoItsFor":["Ages 18 Years to 64 Years","Adults with PTSD related to interpersonal violence"],"whoShouldSkip":["Active or recent (within the last 3 months) severe substance use disorder(s)","Active or recent (within the last 3 months) suicidal, psychotic, or manic symptoms/ episodes","Significant developmental disabilities","Current daily benzodiazepine or stimulant use with inability to abstain for study sessions","Recent changes in psychiatric medication or trauma focused cognitive-behavioral therapy (CBT) (past 4-weeks)","Medical condition(s) that prohibit exercise","History of traumatic brain injury (TBI) with loss of consciousness \\> 30 mins"],"whatHappens":"If you join, the listed intervention(s) are Moderate Intensity Exercise, or Low Intensity Exercise. The registry lists allocation as randomized. The goal of this clinical trial is to test how exercise affects learning and memory processes relevant to the treatment of PTSD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.414Z"},{"nctId":"NCT06132477","title":"Impact GLP-1 Agonists Following Bariatric","officialTitle":"Biometabolic Impact of Continuation of GLP-1 Agonists Following Bariatric","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Missouri-Columbia","sponsorClass":"OTHER","summary":"Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control. Bariatric surgical procedures have been shown to be effective in treating obesity as well as superior to best medical therapy for treatment of diabetes not just through restriction of calories but also through a positive impact in modifications of gut hormones, changes in circulating bile acids, modifications in the gut microflora as well as other undefined mechanisms. The combined benefits of GLP1-RAs with bariatric surgery have only been studied to a limited effect. In this randomized trial, the effects of continuation or discontinuation of GLP1-RA therapy in patients undergoing bariatric surgery will be determined. We will compare changes in weight, metabolic determinants including circulating bile acids and gut microbiome, psychological determinants of eating behavior, and adverse side effects in patients who continue vs discontinue therapy. Given differences in metabolic and clinical outcomes in patients undergoing vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB), both surgical groups will be examined. The study will be conducted at a high volume bariatric surgical program where patients will undergo randomization at the time of final clinic visit prior to surgery to continue or discontinue GLP1-RA. It is hypothesized that participants who continue GLP1-RA therapy after bariatric surgery will lose more weight with improved blood glucose control than those who discontinue therapy. Furthermore, changes in gut microbiome and circulating bile acids, known determinants of metabolic health, will be modified to a differential extent in those who are on GLP1-RAs vs those where GLP1-RAs are discontinued. Understanding the role these medications play in not only clinical outcomes after metabolic surgery but potential metabolic mechanisms by which surgery improves patient's metabolic health could help people with obesity and type 2 diabetes make informed decisions about their treatment options as well as advise providers on the continuation of these medications in the perioperative and postoperative period.","conditions":["Morbid Obesity","Metabolic Syndrome","Diabetes Mellitus","Hypertension","Obstructive Sleep Apnea of Adult"],"keywords":["glp-1 agonist","Morbid Obesity","Bariatric Surgery","Metabolic syndrome","Diabetes Mellitus","Hypertension","Obstructive Sleep Apnea"],"interventions":[{"type":"DRUG","name":"GLP-1 receptor agonist"}],"enrollment":150,"startDate":"2024-02-01","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Greater than 18 years of age\n2. Participation in care by one of the surgeons at MU Health Care\n3. Undergoing surgical weight loss through the Weight Management and Metabolic Center\n4. Body mass index of 30-80 kg/m2\n5. Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure\n6. Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomized they will not be enrolled as randomized but can still participate having samples collected.\n7. Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected.\n8. Willingness to have clinical data entered into a prospective database\n9. Additional specimens collected as stated in the protocol will be offered but collection not mandated.\n\n5\\. Taking a GLP-1 agonist as part of their routine medical care apart from any planned surgical procedure. The current standard of care regarding continuation or discontinuation of GLP-1 agonists has not been established and is at the discretion of members of the patient's medical team but to be included the patient and medical care team must be willing to continue or discontinue the GLP-1 agonist after surgery depending on the randomized group.\n\nExclusion Criteria:\n\n1. Pregnant patient\n2. Desire to not participate\n3. Age less than 18\n4. Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure\n5. Not taking a GLP-1 agonist as part of standard medical care\n6. Unwilling to follow-up at required postoperative visits\n7. Unwilling to stop GLP-1 agonist if randomized into group to stop GLP-1 agonist or unwilling to continue the GLP-1 agonist if randomized into that respective group. If chooses to continue or discontinue the medication apart from randomization the patient can still participate as a non-randomized participant","locations":[{"facility":"University of Missouri Hospital","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Randolph, RN","phone":"573-882-4387","email":"randolphjl@health.missouri.edu"}],"primaryOutcomes":["Effect of GLP1-RA on weight loss","Effect of GLP1-RA on circulating bile acids and metabolites","Effector of GLP1-RA on gut microbiome diversity","Effect of GLP1-RA on satiety and hunger","Effect of GLP1-RA on Glycemic control"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity","hypertension","sleep-apnea"],"drugSlugs":[],"locationSlugs":["columbia-missouri"],"enrichment":{"headline":"Phase 4: testing GLP-1 receptor agonist for Morbid Obesity","inPlainEnglish":"Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person. GLP-1 receptor agonists (GLP1-RAs) have been shown to be effective in achieving weight loss in patients with type 2 diabetes while improving blood glucose control.","whoItsFor":["Ages 18 Years to any","Greater than 18 years of age","Participation in care by one of the surgeons at MU Health Care","Undergoing surgical weight loss through the Weight Management and Metabolic Center","Body mass index of 30-80 kg/m2","Meet insurance criteria, as set forth by the patient's insurance policy, to qualify for coverage for weight loss surgery or as a self-pay patient for the weight loss procedure","Planned laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, revisional weight loss surgery, or duodenal switch or modification of. If patients are not willing to be randomly assigned they will not be enrolled as randomly assigned but can still participate having samples collected","Willingness to have blood collected before and after surgical procedure at defined points or at minimum have clinical data collected"],"whoShouldSkip":["Desire to not participate","Patient fails to fulfill insurance mandated criteria and is not interested in paying cash for their procedure","Not taking a GLP-1 agonist as part of standard medical care","Unwilling to follow-up at required postoperative visits"],"whatHappens":"If you join, the listed intervention(s) are GLP-1 receptor agonist. The registry lists allocation as randomized. Glucagon-like peptide 1 (GLP-1) is a hormone that helps regulate blood glucose levels through improved insulin sensitivity and release of insulin from the pancreas, control hunger, induce satiety and plays a role in the metabolic health of a person.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 150 people at Columbia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.948Z"},{"nctId":"NCT06133101","title":"Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)","officialTitle":"Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Marialena Mouzaki","sponsorClass":"OTHER","summary":"A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.","conditions":["Non-Alcoholic Fatty Liver Disease"],"keywords":["NAFLD"],"interventions":[{"type":"DRUG","name":"Standard Soy Milk"},{"type":"DRUG","name":"2% Fat Cow's Milk"}],"enrollment":44,"startDate":"2024-01-15","completionDate":"2028-03","sex":"ALL","minAge":"5 Years","maxAge":"16 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children with overweight/obesity\n* Known NAFLD or elevated ALT (\\>30)\n\nExclusion Criteria:\n\n* Baseline habitual (\\>3 days per week) consumption of soy foods\n* Allergy to soy or cow's milk protein\n* Inability to undergo MRI\n* Recent (past 8 weeks) antibiotic exposure\n* Treatment for existing endocrine disorders\n* MRI PDFF \\<10%","locations":[{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ann Popelar","phone":"(513) 636-8867","email":"Ann.Popelar@cchmc.org"}],"primaryOutcomes":["Change in liver disease severity"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["cincinnati-ohio"],"enrichment":{"headline":"Phase 2: testing Standard Soy Milk for Non-Alcoholic Fatty Liver Disease","inPlainEnglish":"A randomly assigned, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities.","whoItsFor":["Ages 5 Years to 16 Years","Children with overweight/obesity","Known NAFLD or elevated ALT (\\>30)"],"whoShouldSkip":["Baseline habitual (\\>3 days per week) consumption of soy foods","Allergy to soy or cow's milk protein","Inability to undergo MRI","Recent (past 8 weeks) antibiotic exposure","Treatment for existing endocrine disorders"],"whatHappens":"If you join, the listed intervention(s) are Standard Soy Milk, or 2% Fat Cow's Milk. The registry lists allocation as randomized. A randomly assigned, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 44 people at Cincinnati. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.166Z"},{"nctId":"NCT06133972","title":"Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension).","officialTitle":"A Randomized, Double-blind, Placebo-controlled Extension Study, Followed by a Study Treatment Withdrawal or Open-label Period, to Assess the Long-term Safety and Tolerability of Ianalumab in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE Extension)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate long-term safety and tolerability of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).","conditions":["Systemic Lupus Erythematosus"],"keywords":["Systemic Lupus Erythematosus","SLE","B cell depletion","SLEDAI-2K","BILAG-2004","SRI-4, ANA","ianalumab","VAY736"],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Ianalumab"}],"enrollment":550,"startDate":"2024-05-21","completionDate":"2034-04-03","sex":"ALL","minAge":"12 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Signed informed consent prior to participation in the extension study. Parent or legal guardian's signed informed consent and child's assent, if appropriate, are required before any assessment is performed for participants \\<18 years of age. Of note, if the participant reaches age of consent (age as per local law) during the study, they will also need to sign the corresponding study Informed Consent Form (ICF) at the next study visit.\n* Participants must have participated in either one of the two SIRIUS-SLE core studies, CVAY736F12301 or CVAY736F12302, and have completed the treatment period through Week 60 without treatment discontinuation.\n* In the judgement of the investigator, participants must be expected to clinically benefit from continued study treatment.\n\nKey Exclusion Criteria:\n\n* Use of prohibited therapies.\n* Active viral, bacterial or other infections requiring intravenous or intramuscular treatment for clinically significant infection which in the opinion of the investigator will place the participant at risk for participation.\n* Plans for administration of live vaccines during the study period.\n* Pregnant or nursing (lactating) women.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Pinnacle Research Group Llc","city":"Anniston","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Center","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Medical Research","city":"La Palma","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Millennium Clinical Trials","city":"Westlake Village","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Denver","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Res Of W Florida","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GNP Research","city":"Cooper 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participation","Plans for administration of live vaccines during the study period","Pregnant or nursing (lactating) women","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Placebo, or Ianalumab. The registry lists allocation as randomized. This study wants to evaluate long-term whether it is safe and how hard side effects are to live with of ianalumab in participants with systemic lupus erythematosus who have previously completed the treatment period in one of the two SIRIUS-SLE core studies (CVAY736F12301 or CVAY736F12302).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 550 people at 151 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.269Z"},{"nctId":"NCT06136728","title":"Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis","officialTitle":"Dalfampridine Combined With Physical Therapy for Mobility Impairment in People With Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"MGH Institute of Health Professions","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are:\n\n* Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine?\n* Is the combined treatment associated with better outcomes than the medication (dalfampridine) on its own?\n* How do the individual treatments (dalfampridine, physical therapy) alone compare to each other?\n\nParticipants with MS-related mobility deficits will:\n\n* Receive 6 weeks of dalfampridine treatment to assess the effects of this treatment.\n* After stopping the medication for 2 weeks, the investigators will re-evaluate walking, then randomly assign individuals to a 6-week physical therapy program.\n* Half of the participants will receive physical therapy while resuming dalfampridine treatment. The other half of the participants will receive physical therapy without resuming the medication.\n\nResearchers will compare the combination treatment group (medication plus physical therapy) to the physical therapy only group to see if the combined treatment improves walking-related function. Approximately 3 months after finishing the physical therapy program, participants will undergo a final evaluation to see if the treatment effects have been maintained.","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dalfampridine 10 MG [Ampyra]"},{"type":"BEHAVIORAL","name":"Physical therapy"},{"type":"OTHER","name":"Dalfampridine plus physical therapy"}],"enrollment":48,"startDate":"2024-09-20","completionDate":"2027-05","sex":"ALL","minAge":"25 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of MS\n* Expanded Disability Status Scale (EDSS) 6.5 or less\n* Timed 25-Foot Walk 6-45 seconds (average of 2 trials)\n* Able to stand unsupported for at least 10 seconds\n* Montreal Cognitive Assessment 23 or higher\n* Relapse free for at least 3 months\n* Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions\n* Not currently receiving physical therapy\n\nExclusion Criteria:\n\n* Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity\n* Unable to follow a 3-step verbal command in English\n* Hospitalization for any reason in the last 3 months\n* Uncontrolled hypertension or diabetes\n* History of seizures\n* Renal impairment\n* Women who are breastfeeding, pregnant, or trying to become pregnant\n* Contraindications to magnetic resonance imaging (MRI; to be excluded from MRI procedures but may participate if all other criteria are met)","locations":[{"facility":"MGH Institute of Health Professions","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Prudence Plummer, PhD","phone":"617-724-3103","email":"pplummer@mghihp.edu"}],"primaryOutcomes":["Change in Timed 25-Foot Walk (T25FW)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 3: testing Dalfampridine 10 MG [Ampyra] for Multiple Sclerosis","inPlainEnglish":"The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone. The main questions this study will answer are: * Does combining dalfampridine with physical therapy improve mobility more than physical therapy without concurrent dalfampridine?","whoItsFor":["Ages 25 Years to 75 Years","Confirmed diagnosis of MS","Expanded Disability Status Scale (EDSS) 6.5 or less","Timed 25-Foot Walk 6-45 seconds (average of 2 trials)","Able to stand unsupported for at least 10 seconds","Montreal Cognitive Assessment 23 or higher","Relapse free for at least 3 months","Not currently taking dalfampridine or not previously taken and discontinued due to adverse reactions"],"whoShouldSkip":["Co-existing neurological disorders or orthopedic conditions affecting mobility and physical activity","Unable to follow a 3-step verbal command in English","Hospitalization for any reason in the last 3 months","Uncontrolled hypertension or diabetes","History of seizures","Women who are breastfeeding, pregnant, or trying to become pregnant","Contraindications to magnetic resonance imaging (MRI; to be excluded from MRI procedures but may participate if all other criteria are met)"],"whatHappens":"If you join, the listed intervention(s) are Dalfampridine 10 MG [Ampyra], Physical therapy, or Dalfampridine plus physical therapy. The registry lists allocation as randomized. The goal of this clinical trial is to evaluate if combining a medication that can help improve walking in people with multiple sclerosis (MS) with a physical therapy program is better for improving walking than either treatment alone.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 48 people at Boston. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.972Z"},{"nctId":"NCT06138054","title":"MI-CBTech: A Mobile Intervention for Community Integration in Homeless-Experienced Veterans With SMI","officialTitle":"Improving Community Integration in Homeless Veterans With Serious Mental Illness: A Pilot Study of MI-CBT Enhanced With Mobile Technology","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech). The goal of the intervention is to improve community integration in Veterans with serious mental illness (SMI) who have experienced homelessness. A time- and format-matched control arm will include remote mindfulness training. 50 Veterans with SMI experiencing homelessness will be randomized to one of the two arms (25 per arm).","conditions":["Schizophrenia Spectrum Disorders","Psychotic Affective Disorders","Psychotic Mood Disorders","Homelessness","Ill-Housed Persons"],"keywords":["Community Integration","Telerehabilitation","Telemedicine","Cognitive Behavioral Therapy","Motivational Interviewing","Mobile Applications","Smartphone","Smartphone Apps"],"interventions":[{"type":"BEHAVIORAL","name":"MI-CBTech"},{"type":"BEHAVIORAL","name":"Mindfulness control"}],"enrollment":50,"startDate":"2024-04-01","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Veterans currently residing at the VA Greater Los Angeles Mental Health Residential Rehabilitation Treatment Program (Domiciliary)\n* diagnosis of non-affective or affective psychotic illness as confirmed by chart review\n* history of homelessness\n* sufficiently fluent in English to consent, understand procedures, and complete assessments and intervention\n* medically and clinically stable (i.e. able to participate in and complete assessments and intervention).\n\nExclusion Criteria:\n\n* history of clinically significant neurological disorder determined by medical history (e.g., epilepsy)\n* history of serious head injury (i.e., loss of consciousness \\> 1 hour, neuropsychological sequelae, cognitive rehabilitation post head injury)\n* evidence of IQ \\< 70 or developmental disability\n* moderate or severe substance use disorder in the past month based on chart review","locations":[{"facility":"VA Greater Los Angeles Healthcare System, West Los Angeles, CA","city":"West Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy M Jimenez, PhD","phone":"(310) 478-3711","email":"Amy.Jimenez@va.gov"},{"name":"Michael F Green, PhD","phone":"(310) 268-3376","email":"Michael.Green6@va.gov"}],"primaryOutcomes":["Baseline assessment completion rate","End of treatment assessment completion rate","Remote treatment adherence rate","Satisfaction rating index"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["west-los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: MI-CBTech for Schizophrenia Spectrum Disorders","inPlainEnglish":"This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies. The format of the intervention will be a combination of in-person sessions and remote elements delivered via mobile phone (together called MI-CBTech).","whoItsFor":["Ages 18 Years to 65 Years","Veterans currently residing at the VA Greater Los Angeles Mental Health Residential Rehabilitation Treatment Program (Domiciliary)","diagnosis of non-affective or affective psychotic illness as confirmed by chart review","history of homelessness","sufficiently fluent in English to consent, understand procedures, and complete assessments and intervention","medically and clinically stable (i.e. able to participate in and complete assessments and intervention)"],"whoShouldSkip":["history of clinically significant neurological disorder determined by medical history (e.g., epilepsy)","history of serious head injury (i.e., loss of consciousness \\> 1 hour, neuropsychological sequelae, cognitive rehabilitation post head injury)","evidence of IQ \\< 70 or developmental disability","moderate or severe substance use disorder in the past month based on chart review"],"whatHappens":"If you join, the listed intervention(s) are MI-CBTech, or Mindfulness control. The registry lists allocation as randomized. This study aims to test the feasibility and acceptability of a brief behavioral intervention that combines two treatments, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT), that have been shown to work in prior research studies.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at West Los Angeles. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.039Z"},{"nctId":"NCT06141031","title":"Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma","officialTitle":"Phase I/IB Trial of Radiotherapy in Combination With TTI-101 in Borderline Resectable and Locally Advanced Pancreatic Ductal Adenocarcinoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression). This study exploits the window of opportunity post-chemotherapy to advance the hypothesis that the addition of STAT3 inhibition in combination with SBRT will be safe and will enhance 2-year progression-free survival.","conditions":["Pancreatic Cancer"],"keywords":["borderline resectable","locally advanced"],"interventions":[{"type":"DRUG","name":"TTI-101"},{"type":"RADIATION","name":"Stereotactic body radiation therapy"}],"enrollment":24,"startDate":"2024-01-16","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically confirmed pancreatic adenocarcinoma that is borderline resectable or locally advanced as defined by NCCN guidelines, with no expected arterial resection/reconstruction.\n* Patients who are borderline resectable must have completed standard of care induction chemotherapy between 1 and 3 weeks prior to planned start of TTI-101 + SBRT. Patients who exceed this window may be considered for enrollment if they complete an additional cycle of induction chemotherapy prior to initiation of study treatment (per provider discretion). The receipt and/or amount of induction chemotherapy cycles allowed will be left to the discretion of the treating medical oncologist. There is no timing restriction or chemotherapy receipt for patients with locally advanced disease.\n* At least 18 years of age.\n* ECOG performance status ≤ 2\n* Adequate bone marrow and organ function as defined below:\n\n  * Absolute neutrophil count ≥ 1.0 K/cumm\n  * Platelets ≥ 70 K/cumm\n  * Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion)\n  * Total bilirubin ≤ 2 mg/dL\n  * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN\n  * Serum albumin ≥ 2.8 g/dL\n  * Ionized calcium ≤ 1.5 mmol/L, calcium ≤ 12 mg/dL, or corrected serum calcium ≤ IULN)\n  * Measured creatinine clearance \\> 40 mL/min or calculated creatinine clearance \\> 40 mL/min by Cockcroft-Gault or by 24-hour urine collection for determination of creatinine clearance (calculations in protocol).\n* Able to swallow pills and has been deemed an appropriate candidate for investigational TTI-101 treatment based on the opinion of both the treating radiation oncologist and the treating medical oncologist.\n* INR and aPTT ≤ 1.5 x IULN unless patient is receiving anticoagulant therapy (in which case INR and PTT must be within therapeutic range of intended use of anticoagulants)\n* The effects of TTI-101 on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use at least 1 highly effective method of contraception from screening through the duration of study participation, and for 30 days after last dose of TTI-101. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform the treating physician immediately.\n* Agreement to adhere to Lifestyle Considerations throughout study duration.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Prior irradiation of pancreatic cancer in the past 2 years.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device overlapping with study treatments within 3 months preceding study entry at the discretion of the PI.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101 or other agents used in the study.\n* Uncontrolled intercurrent illness including but not limited to: ongoing or active infection (fungal, bacterial, or viral (including COVID-19)), sepsis, acute and chronic active infectious disorders (including viral and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy), and chronic pancreatitis. Patients with a recent COVID-19 diagnosis must have fully recovered from all COVID-19 symptoms for 2 weeks prior to the start of study treatment.\n* Significantly impaired cardiac function such as symptomatic congestive heart failure with NYHA Class III or IV, unstable angina pectoris, myocardial infarction within the last 12 months prior to study entry, serious cardiac arrhythmia (including QTc prolongation of \\> 470 ms and/or pacemaker), or prior diagnosis of congenital long QT syndrome.\n* Ongoing toxicity due to induction chemotherapy, unless returned to baseline or grade 1 or less (except alopecia and labs noted in inclusion criterion #5).\n* Has had major surgery within 3 weeks prior to starting TTI-101 or has not recovered from major side effects due to surgery.\n* Presence of pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequent). Participants with indwelling catheters for control of effusions or ascites are allowed.\n* History of cerebrovascular accident or stroke within the previous 2 years.\n* History of hepatic encephalopathy.\n* Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).\n* History of malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance or absorption of TTI-101.\n* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 5 days of study entry.\n* HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.\n* Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.\n* History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.","locations":[{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sana Karam, M.D., Ph.D.","phone":"314-273-3240","email":"sanadkaram@wustl.edu"}],"primaryOutcomes":["Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of TTI-101 and SBRT"],"hasResults":false,"conditionSlugs":["pancreatic-cancer","als"],"drugSlugs":[],"locationSlugs":["aurora-colorado","st-louis-missouri"],"enrichment":{"headline":"Phase 1: testing TTI-101 for Pancreatic Cancer","inPlainEnglish":"The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival. Preclinical research has established that STAT3 inhibition given concurrently with SBRT and in the maintenance phase acts as a synergistic agent that enhances the pro-inflammatory effects of SBRT while reducing its undesired effects (including fibrosis and immunosuppression).","whoItsFor":["Ages 18 Years to any","Pathologically confirmed pancreatic adenocarcinoma that is borderline resectable or locally advanced as defined by NCCN guidelines, with no expected arterial resection/reconstruction","At least 18 years of age","how well you can do daily activities (ECOG score) ≤ 2","Adequate bone marrow and organ function as defined below:","Absolute neutrophil count ≥ 1.0 K/cumm","Platelets ≥ 70 K/cumm","Hemoglobin ≥ 9.0 g/dL (patients may be transfused to meet this criterion)"],"whoShouldSkip":["Prior irradiation of pancreatic cancer in the past 2 years","Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or how well it works assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial","Currently receiving any other investigational agents or has participated in a study of an investigational agent or using an investigational device overlapping with study treatments within 3 months preceding study entry at the discretion of the PI","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to TTI-101 or other agents used in the study","Ongoing toxicity due to induction chemotherapy, unless returned to baseline or grade 1 or less (except alopecia and labs noted in inclusion criterion #5)","Has had major surgery within 3 weeks prior to starting TTI-101 or has not recovered from major side effects due to surgery","Presence of pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequent). Participants with indwelling catheters for control of effusions or ascites are allowed"],"whatHappens":"If you join, the listed intervention(s) are TTI-101, or Stereotactic body radiation therapy. The registry lists allocation as randomized. The survival rate for patients with pancreatic cancer remains at a dismal 10% or less at 5 years, and although trials integrating stereotactic body radiation therapy (SBRT) alone have shown improvement in local control, initial invigoration of immune response, and relief of symptom burden, SBRT has not demonstrated any improvement in survival.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.453Z"},{"nctId":"NCT06143527","title":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS","officialTitle":"Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for the Treatment of Polycystic Ovary Syndrome","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Foundation for Orthopaedics and Regenerative Medicine","sponsorClass":"OTHER","summary":"This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.","conditions":["Polycystic Ovary Syndrome (PCOS)","Polycystic Ovary Syndrome","PCOS"],"keywords":["Polycystic Ovary Syndrome (PCOS)","Polycystic Ovary Syndrome","PCOS","Stem Cell","Stem Cells","Mesenchymal Stem Cells","Umbilical Cord Derived Mesenchymal Stem Cells"],"interventions":[{"type":"BIOLOGICAL","name":"Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells"}],"enrollment":20,"startDate":"2023-11-16","completionDate":"2027-11-16","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n• Ultrasound documented poly cystic ovary syndrome\n\nExclusion Criteria:\n\n* Active infection\n* Active cancer\n* Chronic multisystem organ failure\n* Pregnancy\n* Clinically significant abnormalities on pre-treatment laboratory evaluation\n* Medical condition that would (based on the opinion of the investigator) compromise patient's safety\n* Continued drug abuse\n* Previous organ transplant\n* Hypersensitivity to sulfur\n* Inability to supply proper informed consent","locations":[{"facility":"Prodromos Stem Cell Institute","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prodromos Stem Cell Institute","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chadwick Prodromos, MD","phone":"847-699-6810","email":"care@thepsci.com"}],"primaryOutcomes":["Safety: Adverse Events"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["naples-florida","athens-greece"],"enrichment":{"headline":"Phase 1: testing Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for Polycystic Ovary Syndrome (PCOS)","inPlainEnglish":"This trial will study the safety and how well it works of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.","whoItsFor":["Ages 18 Years to any","Women only","Ultrasound documented poly cystic ovary syndrome"],"whoShouldSkip":["Chronic multisystem organ failure","Clinically significant abnormalities on pre-treatment laboratory evaluation","Medical condition that would (based on the opinion of the investigator) compromise patient's safety","Continued drug abuse","Previous organ transplant","Hypersensitivity to sulfur"],"whatHappens":"If you join, the listed intervention(s) are Cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells. The registry lists allocation as na. This trial will study the safety and how well it works of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells delivered intravenously for the treatment of Polycystic Ovary Syndrome.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.787Z"},{"nctId":"NCT06143956","title":"A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight","officialTitle":"A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.","conditions":["Obesity","Overweight"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY3305677"},{"type":"DRUG","name":"LY3841136"},{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"LY3549492"},{"type":"DRUG","name":"LY3532226"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Placebo"}],"enrollment":1481,"startDate":"2023-11-17","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a body mass index (BMI)\n\n  * ≥30 kilogram/square meter (kg/m²), or\n  * ≥27 kg/m² and \\<30 kg/m², or with at least 1 weight-related comorbidity\n* Have had a stable body weight for the 3 months prior to randomization (\\<5%) body weight gain and/or loss.\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening.\n* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.\n* Have poorly controlled hypertension.\n* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.\n* Have any of the following cardiovascular conditions within 3 months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure.\n* Have a history of symptomatic gallbladder disease within the past 2 years.\n* Have a lifetime history of suicide attempts.","locations":[{"facility":"The Institute for Liver Health II dba Arizona Clinical Trials - Mesa","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOPE Research Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Headlands Research - Scottsdale","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II dba Arizona Liver Health-Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NorCal Medical Research, Inc","city":"Greenbrae","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Huntington Park","city":"Huntington Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula Research Associates","city":"Rolling Hills Estates","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stamford Therapeutics Consortium","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Research Institute (NERI)","city":"Fleming Island","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"New Horizon Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indago Research & Health Center, Inc","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Winter Park","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Lady Lake","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Diabetes & Endocrine Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Medical Research Partners","city":"Ammon","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Clinical Trials - Ravenswood","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"NorthShore University Health System","city":"Skokie","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Iowa Diabetes and Endocrinology Research Center","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Diabetes & Endocrinology","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research - Louisville","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knownwell","city":"Needham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucida Clinical Trials","city":"New Bedford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research - Detroit","city":"Southfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcturus Healthcare , PLC, Troy Internal Medicine Research Division","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinvest Headlands Llc","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Las Vegas Medical Research","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dent Neurologic Institute","city":"Amherst","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Syracuse","city":"East Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Suffolk Neurology","city":"Port Jefferson Station","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rochester Clinical Research, LLC","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medication Management","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucas Research, Inc","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucas Research, Inc.","city":"New Bern","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTI Clinical Research Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tribe Clinical Research, LLC","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quality Medical Research","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PlanIt Research, PLLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Clinical Trials","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research - Fredericksburg Road","city":"San Antonio","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Texas Valley Clinical Research","city":"Weslaco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sovah Clinical Research-River District","city":"Danville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Washington Health Services Association d/b/a Confluence Health","city":"Wenatchee","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cicemo Srl","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CARDIAMET Investigaciones Médicas","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Metabólicas (CINME)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Médico Viamonte","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mautalen Salud e Investigación","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Catamarca IMEC","city":"Rosario","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants Allocated to Each ISA"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["chandler-arizona","phoenix-arizona","scottsdale-arizona","tucson-arizona","greenbrae-california","huntington-park-california","rolling-hills-estates-california","walnut-creek-california","stamford-connecticut","fleming-island-florida","miami-florida","miami-lakes-florida","new-port-richey-florida","orlando-florida","the-villages-florida","honolulu-hawaii","ammon-idaho","chicago-illinois","skokie-illinois","west-des-moines-iowa","topeka-kansas","louisville-kentucky","needham-massachusetts","new-bedford-massachusetts","southfield-michigan","troy-michigan","city-of-saint-peters-missouri","springfield-missouri","las-vegas-nevada","amherst-new-york","east-syracuse-new-york","port-jefferson-station-new-york","rochester-new-york","greensboro-north-carolina","monroe-north-carolina","morehead-city-north-carolina","new-bern-north-carolina","cincinnati-ohio","greenville-south-carolina","nashville-tennessee","austin-texas","dallas-texas","houston-texas","san-antonio-texas","weslaco-texas","danville-virginia","wenatchee-washington","buenos-aires-argentina","rosario-argentina"],"enrichment":{"headline":"Phase 2: testing LY3305677 for Obesity","inPlainEnglish":"The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to measure the safety and how well it works of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs.","whoItsFor":["Ages 18 Years to 75 Years","Have a body mass index (body-mass index (BMI))","≥30 kilogram/square meter (kg/m²), or","≥27 kg/m² and \\<30 kg/m², or with at least 1 weight-related comorbidity","Have had a stable body weight for the 3 months prior to randomization (\\<5%) body weight gain and/or loss"],"whoShouldSkip":["Have a prior or planned surgical treatment for obesity, except prior liposuction or abdominoplasty, if performed \\>1 year prior to screening","Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma","Have poorly controlled hypertension","Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease","Have any of the following cardiovascular conditions within 3 months prior to screening:","acute myocardial infarction","cerebrovascular accident (stroke)"],"whatHappens":"If you join, the listed intervention(s) are LY3305677, LY3841136, or Tirzepatide. The registry lists allocation as randomized. The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to measure the safety and how well it works of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 1,481 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.034Z"},{"nctId":"NCT06144164","title":"A Study of a Comprehensive Prevention Program to Reduce Lymphedema After Axillary Lymph Node Dissection in People With Breast Cancer","officialTitle":"A Prospective Cohort Study of Patients Undergoing ALND for Treatment of Breast Cancer: The Efficacy of a Comprehensive Prevention Program in Decreasing the Incidence of Lymphedema and Improving Quality of Life","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.","conditions":["Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Breast Cancer","Breast Carcinoma","Female Breast Cancer"],"keywords":["immediate lymphatic reconstruction","axillary lymph node dissection","Lymphedema","Lymphedema Arm","Lymphedema of Upper Arm","Breast cancer","breast carcinoma","female breast cancer","Memorial Sloan Kettering Cancer Center","23-303"],"interventions":[{"type":"PROCEDURE","name":"Immediate Lymphatic Reconstruction"},{"type":"DIAGNOSTIC_TEST","name":"Volumetric arm measurements"},{"type":"OTHER","name":"Lymphatic massage"},{"type":"OTHER","name":"Range of motion exercises"},{"type":"OTHER","name":"Compression garment use"}],"enrollment":285,"startDate":"2023-11-16","completionDate":"2030-03-16","sex":"FEMALE","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female sex\n* Diagnosis of breast cancer\n* Ages 18 to 75 years\n* Consented for unilateral ALND or for unilateral SLNB with possible ALND\n\nExclusion Criteria:\n\n* Male sex\n* Does not speak English\n* Does not fit into study garment\n* Axillary recurrence\n* History of ALND\n* Requirement of bilateral ALND for the treatment of breast cancer\n* Treatment with SLNB only\n* Known anaphylactic allergy to ICG dye used in ILR\n* Impaired decision-making capacity","locations":[{"facility":"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle Coriddi, MD","phone":"646-608-8042","email":"coriddim@mskcc.org"},{"name":"Babak Mahrara, MD","phone":"646-608-8085","email":"mehrarab@MSKCC.ORG"}],"primaryOutcomes":["The difference between the baseline and postoperative arm volume measurement"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york"],"enrichment":{"headline":"Phase 3: Immediate Lymphatic Reconstruction for Lymphedema","inPlainEnglish":"The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.","whoItsFor":["Ages 18 Years to 75 Years","Women only","Diagnosis of breast cancer","Ages 18 to 75 years","Consented for unilateral ALND or for unilateral SLNB with possible ALND"],"whoShouldSkip":["Does not fit into study garment","Axillary recurrence","Requirement of bilateral ALND for the treatment of breast cancer","Treatment with SLNB only","Known anaphylactic allergy to ICG dye used in ILR","Impaired decision-making capacity"],"whatHappens":"If you join, the listed intervention(s) are Immediate Lymphatic Reconstruction, Volumetric arm measurements, or Lymphatic massage. The registry lists allocation as na. The purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 285 people at 7 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.950Z"},{"nctId":"NCT06145022","title":"Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients","officialTitle":"Effect of a Stress Reduction and Lifestyle Modification Programme on the Quality of Life of Irritable Bowel Syndrome Patients (MBM IBS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Universität Duisburg-Essen","sponsorClass":"OTHER","summary":"In the planned efficacy study, a prospective randomized controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study. The intervention group will participate in a partial outpatient multimodal stress reduction and lifestyle modification program over 10 weeks, while the waitlist control group will only receive an educational session and written information on treatment and self-help options. The primary research question encompasses the examination of the program's impact on the severity of symptoms associated with irritable bowel syndrome (measured with the IBS-Symptom Severity Scale \\[IBS-SSS\\]) and additionally its influence on quality of life, stress, and mental well-being. Another aspect of the study is the utilization of medical services (e.g., comparing the number of doctor visits; intake of prescribed and over-the-counter medications). Additionally, a comparison of days of work disability will be conducted.","conditions":["Irritable Bowel Syndrome"],"keywords":["lifestyle modification","Mind-Body medicine","integrative medicine"],"interventions":[{"type":"BEHAVIORAL","name":"lifestyle modification"},{"type":"BEHAVIORAL","name":"waitlist control group"}],"enrollment":118,"startDate":"2024-03-06","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score \\> 75\n\nExclusion Criteria:\n\n* Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)\n* Severe comorbid somatic illness (e.g., oncological disease)\n* Pregnancy\n* Participation in other stress reduction programs or clinical studies on psychological interventions\n* Known intolerances (fructose, lactose), celiac disease, etc.","locations":[{"facility":"Sozialstiftung Bamberg","city":"Bamberg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sandra Utz, PhD","phone":"+49 951 503","email":"sandra.utz@sozialstiftung-bamberg.de"},{"name":"Christine Uecker","phone":"+49 951 503","email":"christine.uecker@sozialstiftung-bamberg.de"}],"primaryOutcomes":["Severity of IBS symptoms by IBS-SSS","Severity of IBS symptoms by IBS-SSS","Severity of IBS symptoms by IBS-SSS","overall change in health status","overall change in health status"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["bamberg-germany"],"enrichment":{"headline":"Not a traditional drug phase: lifestyle modification for Irritable Bowel Syndrome","inPlainEnglish":"In the planned how well it works study, a prospective randomly assigned controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study. For this purpose, 118 patients with IBS will be enrolled in a clinical study.","whoItsFor":["Ages 18 Years to 75 Years","confirmed diagnosis of irritable bowel syndrome (IBS with diarrhea, IBS with constipation, mixed-type IBS, or unspecified IBS); IBS-SSS Score \\> 75"],"whoShouldSkip":["Severe mental illness (e.g., clinically significant depression, substance use disorder, schizophrenia)","Severe comorbid somatic illness (e.g., oncological disease)","Participation in other stress reduction programs or clinical studies on psychological interventions","Known intolerances (fructose, lactose), celiac disease, etc"],"whatHappens":"If you join, the listed intervention(s) are lifestyle modification, or waitlist control group. The registry lists allocation as randomized. In the planned how well it works study, a prospective randomly assigned controlled trial will be conducted to investigate the extent to which a multimodal stress reduction and lifestyle modification program can be reflected in patients with irritable bowel syndrome (IBS) within the framework of a clinical study.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 118 people at Bamberg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.428Z"},{"nctId":"NCT06147414","title":"Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders","officialTitle":"Evaluation of the Diagnostic Performance of Non-Invasive Prenatal Diagnosis for Single Gene Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD). This can be performed from 9 weeks of amenorrhea and offers an early, safe and accurate definitive diagnosis without the miscarriage risk associated with invasive procedures. One of the major difficulties is distinguishing fetal genotype in the high background of maternal cfDNA, which leads to several technical and analytical challenges. Besides, unlike noninvasive prenatal testing for aneuploidy, NIPD for monogenic diseases represent a smaller market opportunity, and many cases must be provided on a bespoke, patient- or disease-specific basis. As a result, implementation of SGD-NIPD remained sparse, with most testing being delivered in a research setting.\n\nThe present project aims to take advantage of the unique French collaborative network to make SGD-NIPD possible for theoretically any monogenic disorder and any family.","conditions":["Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including","Sickle Cell Disease","Cystic Fibrosis","Fragile X Syndrome","Proximal Spinal Muscular Atrophy","Myotonic Dystrophy","Muscular Dystrophy, Duchenne","Muscular Dystrophy, Becker","Neurofibromatosis-Noonan Syndrome","Huntington Disease","Hemophilia A","Hemophilia B","MODY2 Diabetes","X-Linked Hydrocephalus","Autosomal Recessive Polycystic Kidney Disease"],"keywords":["Gene HBB","Gene CFTR","Gene FMR1","Gene SMN1","Gene DMPK","Gene DMD","Gene NF1","Gene HTT","Gene F8","Gene F9","Gene GCK","Gene L1CAM","Gene PKHD1"],"interventions":[{"type":"BIOLOGICAL","name":"Blood sample"}],"enrollment":550,"startDate":"2024-10-23","completionDate":"2027-05","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* pregnant woman with 9 weeks of amenorrhea or more\n* singleton pregnancy\n* undergoing invasive PND in a context of family history of SGD involving the following genes : HBB, CFTR, FMR1, SMN1, DMPK, DMD, NF1, HTT, F8, F9, GCK, L1CAM, PKHD1, or undergoing prenatal counselling in a context of maternal history of diabetes MODY-GCK\n* germinal pathogenic paternal and/or maternal mutations previously identified\n* age 18 years old or over\n* signing an informed consent\n\nExclusion Criteria:\n\n* at risk of SGD involving a de novo pathogenic mutation in a previous child\n* woman under legal protection","locations":[{"facility":"Hôpital Cochin, Maternité Port-Royal, service de Gynécologie obstétrique","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juliette NECTOUX, MD,PhD","phone":"01 58 41 11 86","email":"juliette.nectoux@aphp.fr"},{"name":"Christelle AUGER","phone":"01 71 76 07 53","email":"christelle.auger@aphp.fr"}],"primaryOutcomes":["% of affected/unaffected fetuses that were correctly classified as affected/unaffected","% of inconclusive results"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Blood sample for Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including","inPlainEnglish":"Cell-free fetal DNA (cffDNA) is present in the maternal blood from the early first trimester of gestation and makes up 5%-20% of the total circulating cell-free DNA (cfDNA) in maternal plasma. Its presence in maternal plasma has allowed development of noninvasive prenatal diagnosis for single-gene disorders (SGD-NIPD).","whoItsFor":["Ages 18 Years to any","Women only","pregnant woman with 9 weeks of amenorrhea or more","singleton pregnancy","undergoing invasive PND in a context of family history of SGD involving the following genes : HBB, CFTR, FMR1, SMN1, DMPK, DMD, NF1, HTT, F8, F9, GCK, L1CAM, PKHD1, or undergoing prenatal counselling in a context of maternal history of diabetes MODY-GCK","germinal pathogenic paternal and/or maternal mutations previously identified","age 18 years old or over"],"whoShouldSkip":["at risk of SGD involving a de novo pathogenic mutation in a previous child","woman under legal protection"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 550 people at Paris. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.840Z"},{"nctId":"NCT06149481","title":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","officialTitle":"Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nEach year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC). Most people with mCRC survive only about 2 years.\n\nObjective:\n\nTo test the ability of a combination of up to 4 experimental anti-cancer drugs treat mCRC. The names of these drugs are retifanlimab, TriAdeno vaccine, N-803, and SX-682. They are described below.\n\nEligibility:\n\nAdults aged 18 years or older with mCRC. Participants must have\n\nDesign:\n\nParticipants will be screened. This includes having a physical exam, blood tests, urine tests, and imaging tests. If signed on to the study, participants will have 2 tumor biopsies. One when starting the study and once about 8 weeks after bring on the study. Participants will receive $500 for each biopsy.\n\nParticipants will be treated with either 3 or 4 drugs and will receive a detailed calendar explaining when each drug is given.\n\nRetifanlimab is given every 4 weeks through an IV (an IV is tube attached to a needle inserted into a vein in the arm). N-803 is injected under the skin on the abdomen every 4 weeks.\n\nTriAdeno vaccine is injected under the skin of the upper arm or thigh once a month for 3 doses and then once every 3 months.\n\nSome participants will also receive a 4th drug. SX-682 is a pill taken by mouth. Participants will take this drug 2 times a day at home for about 3 weeks of each month.\n\nStudy treatment will continue up to 2 years. Follow-up phone calls/emails may continue for 3 more years.","conditions":["Metastatic Colorectal Cancer"],"keywords":["Monoclonal Antibody","Brachyury","MUC-1","Immunoglobulin G cytokine fusion protein","chemokine antagonist","Small Molecule"],"interventions":[{"type":"DRUG","name":"Retifanlimab"},{"type":"BIOLOGICAL","name":"Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform"},{"type":"DRUG","name":"N-803"},{"type":"DRUG","name":"SX-682"}],"enrollment":60,"startDate":"2024-03-26","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants with histologically confirmed colorectal cancer and evidence of metastatic disease.\n* Participants must have received, been ineligible to receive, or refused to receive two lines of standard systemic therapy i.e., a fluoropyrimidine with oxaliplatin or irinotecan with bevacizumab, regorafenib, trifluridine, and (if history of RAS wild-type) EGFR-targeted therapy. Participants must have received one line of systemic checkpoint inhibitor if history of advanced microsatellite instability-high \\[MSI-H/dMMR\\]) metastatic colon cancer.\n* Participants who had progressive disease within 6 months before study treatment following standard adjuvant therapy are eligible if they have not received systemic therapy for metastatic disease. Participants with a history of MSI-H/dMMR must have also received one line of checkpoint inhibitor therapy.\n* Age \\>= 18 years.\n* Measurable disease per RECIST 1.1.\n* ECOG performance status \\<= 2.\n* Adequate organ and marrow as a function defined below:\n\n  * absolute neutrophil count (ANC) \\>= 1,500 cells/mm\\^3\n  * platelet count \\>= 100,000 cells/mm\\^3\n  * hemoglobin (Hgb) \\>= 9 g/dL\n  * total bilirubin level \\< 1.5 x upper limit of normal (ULN)\n  * alanine aminotransferase (ALT) \\<= 2.5 x ULN OR \\<= 5 x ULN for participants with liver metastases\n  * aspartate aminotransferase (AST) level \\<= 2.5 x ULN OR \\<= 5 x ULN for participants with liver metastases\n  * creatinine clearance (CrCl) calculated by Cockroft-Gault formula \\>= 50 mL/min\n* Resolution of toxic effect(s) of prior anti-cancer therapy (except alopecia and neuropathy) to Grade \\<=1 or to \\<=2 if effective medical management of those toxicities is in place such that they are controlled per standard of care (e.g., grade 2 hypothyroidism requiring oral thyroid replacement).\n* Participants with treated brain metastases are eligible if clinically appropriate follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n* Participants positive for human immunodeficiency virus (HIV) are eligible if they are compliant with appropriate anti-retroviral therapy for at least 6 months, have HIV viral load \\<400 copies/mL, and a CD4 count \\> 350 cells/microliter at screening.\n* Participants positive for Hepatitis C virus (HCV) are eligible if they have completed definitive anti-viral therapy and have an undetectable viral load.\n* Individuals of child-bearing potential (IOCBP) and individuals who can father children must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization) at study entry and up to 6 months after the last dose of the study drug(s).\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after study treatment discontinuation.\n* Participants must have lesion(s) accessible for biopsy (other than used for measurement of disease) and be willing to undergo mandatory study biopsies in the phase 1 portion of the study. Lesions to be biopsied will be determined safely accessible by the provider performing the biopsy (e.g. interventional radiology if a liver or lung biopsy) prior to performing the biopsy. Note: If Phase 2 opens, per the investigator s discretion, if biopsy is strenuous to obtain, e.g., no easily accessible lesions are available or the subject\n\ncondition is not amenable for biopsy, then the subject will be eligible for enrollment without biopsy at screening and for continuation of treatment without on-treatment study biopsy.\n\n-Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation.\n* Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation.\n* Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg/day of prednisone or equivalent) with the exception of:\n\n  * intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma\n  * using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption\n  * brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy).\n* Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Participants with chronic post-radiation pulmonary changes/scarring that is asymptomatic are eligible.\n* Active infections requiring systemic antibiotics or antifungal or antiviral treatment within 8 days prior to treatment initiation. Participants who have had appropriate antibiotics initiated but are still completing the treatment course are eligible if clinically improved or had minimal symptoms at presentation (e.g., urinary tract infection or pharyngeal streptococcal infection without evidence of systemic inflammatory response).\n\n  * History of organ transplant, including allogeneic stem cell transplantation.\n  * Participants who experienced immune-related toxicity during prior checkpoint inhibitor therapy for which permanent discontinuation of therapy was recommended (per product label or consensus guidelines) or any immune-related toxicity requiring systemic corticosteroids (with the exception of endocrinopathy that is well controlled on replacement hormones).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs.\n* Receipt of a live vaccine within 28 days prior to treatment initiation. Note: Examples of live vaccines include but are not limited to measles, mumps, rubella, varicella-zoster (chickenpox), yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are generally killed-virus vaccines and are allowed; however, intranasal influenza vaccines are live, attenuated vaccines and are not allowed.\n* History of infection with Hepatitis B virus (HBV) unless on suppressive therapy. Individuals with serologic evidence of a resolved prior HBV infection (i.e., HBsAgnegative and anti-HBc positive) are eligible.\n* Pregnancy confirmed with Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Referral Office","phone":"(888) 624-1937","email":"ncimo_referrals@nih.gov"}],"primaryOutcomes":["Phase I: Safety profiles of the IO regimens consisting of retifanlimab, TriAdeno vaccine, N-803 (A1), and retifanlimab, TriAdeno vaccine, N-803, SX-682 (A2) in participants with metastatic colorectal cancer","Phase II: Overall response rate (ORR) defined as the CR+PR of the IO regimen in mCRC"],"hasResults":false,"conditionSlugs":["colorectal-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Retifanlimab for Metastatic Colorectal Cancer","inPlainEnglish":"Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs. This is called metastatic colorectal cancer (mCRC).","whoItsFor":["Ages 18 Years to 120 Years","Participants with histologically confirmed colorectal cancer and evidence of metastatic disease","Measurable disease per RECIST 1.1","how well you can do daily activities (ECOG score) \\<= 2","Adequate organ and marrow as a function defined below:","absolute neutrophil count (ANC) \\>= 1,500 cells/mm\\^3","platelet count \\>= 100,000 cells/mm\\^3","hemoglobin (Hgb) \\>= 9 g/dL"],"whoShouldSkip":["Participants with prior investigational drug, chemotherapy, immunotherapy, or any prior therapeutic radiotherapy within 14 days prior to study treatment initiation","Participants with palliative radiotherapy performed within 7 days prior to study treatment initiation","Active autoimmune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\> 10 mg/day of prednisone or equivalent) with the exception of:","intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections in participants with asthma","using topical, ocular, intra-articular, or intranasal corticosteroids (with minimal systemic absorption","brief courses of corticosteroids for prophylaxis (e.g., contrast dye allergy)","Evidence of interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis. Participants with chronic post-radiation pulmonary changes/scarring that is asymptomatic are eligible"],"whatHappens":"If you join, the listed intervention(s) are Retifanlimab, Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform, or N-803. The registry lists allocation as randomized. Background: Each year, more than 32,000 people in the United States are diagnosed with colorectal cancer that has returned or progressed after treatment and spread to other organs.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.066Z"},{"nctId":"NCT06150664","title":"A Phase 1 of CTX-8371 in Patients With Advanced Malignancies","officialTitle":"A Phase 1, Open-Label, Multiple-Ascending Dose Study of the Safety and Tolerability of CTX-8371 in Patients With Advanced Malignancies","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Compass Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.","conditions":["Non Small Cell Lung Cancer","Triple Negative Breast Cancer","Hodgkin Lymphoma","Head and Neck Squamous Cell Carcinoma","Malignant Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"CTX-8371"}],"enrollment":85,"startDate":"2024-03-19","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years or older\n2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including\n\n   1. Malignant Melanoma (MM)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody\n      * Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor\n      * Uveal and mucosal melanoma are excluded\n   2. Head and Neck squamous cell carcinoma (HNSCC)\n\n      * HNSCC of oral cavity, oropharynx, hypopharynx, or larynx\n      * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   3. Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   4. Triple Negative Breast Cancer (TNBC)\n\n      * ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)\n      * Patients with HER2-low cancers (HER2 IHC 1+ or 2+/ISH negative) are excluded\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n   5. Classical Hodgkin Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor\n      * Patients must have experienced less than a CR (according to Lugano criteria) to anti- PD-1 treatment\n   6. (Cohort 2 Dose Expansion): Non-Small Cell Lung Cancer (NSCLC)\n\n      * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment\n      * Patients must have received prior treatment with platinum-based chemotherapy\n   7. (Cohort 2 Dose Expansion) Triple Negative Breast Cancer (TNBC)\n\n      * ER/PR and HER2 status should be defined by ASCO/CAP guidelines (JCO Allison et al 2020)\n      * Patients must have received prior sacituzumab govitecan and if PD-L1 ≥10% by CPS pembrolizumab with chemotherapy\n      * Patients with HER2-low tumors (HER2 IHC 1+ or 2+/ISH negative) need to have received fam-trastuzumab deruxtecan (Enhertu)\n   8. (Cohort 2 Dose Expansion) Classical Hodgkin's Lymphoma (HL)\n\n      * Patients must have received at least two prior systemic therapies including brentuximab vedotin (if eligible) and a prior PD-1 inhibitor.\n      * Patients must have received at least 12 weeks of treatment with a PD-1/PD-L1 inhibitor as a monotherapy or in combination and had at least stable disease or progressive disease (PD) with overall clinical benefit.\n3. Patients with NSCLC, MM, TNBC, and HNSCC must have measurable disease per RECIST 1.1. Patients with HL must have at least one measurable lesion \\> 1.5 cm for nodal, \\> 1.0 cm for extranodal FDG-avid disease by the Lugano (2014) response criteria. Tumor sites that are considered measurable must not have received prior radiation\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n5. Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion)\n\n   a. (Cohort 2 Dose Expansion) Adequate bone marrow function defined by absolute neutrophil (ANC) of ≥ 1.5×109/L, platelet count of ≥ 100.0×109/L, and hemoglobin of ≥ 9.0 g/dL (with or without transfusion) within 2 weeks from the first dose of CTX-8371.\n\n   \\- Blood transfusion is not allowed within 2 weeks from the first dose of CTX-8371\n6. Adequate hepatic function defined as serum total bilirubin ≤ 1.5 × ULN, AST/ALT ≤ 2.5 × ULN (or ≤ 5 × ULN in patients with liver metastases)\n7. Adequate renal function defined as creatinine clearance ≥ 30mL/min by Cockcroft-Gault equation\n8. Female patients must be surgically sterile (or have a monogamous partner who is surgically sterile) or be at least 2 years postmenopausal or commits to use 2 acceptable forms of birth control (defined as the use of an intrauterine device (IUD), a barrier method with spermicide, condoms, any form of hormonal contraceptives) or abstinence for the duration of the study and for 4 months following the last dose of study treatment. Male patients must be sterile (biologically or surgically) or commit to the use of a reliable method of birth control (condoms with spermicide) for the duration of the study and for 4 months following the last dose of study treatment\n9. Female patients who are women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening within 7 days of dosing with CTX-8371\n10. Last dose of previous PD-1 or PD-L1 therapy ≥ 28 days, other anticancer therapy \\> 21 days (or 2 half-lives for proteins, whichever is longer), radiotherapy \\>21 days (concurrent localized palliative radiotherapy is allowed during CTX-8371 treatment), or surgical intervention \\>21 days prior to the first dose of CTX-8371\n11. Resolution of all prior anti-cancer therapy toxicities ≤ Grade 2\n12. Life expectancy ≥ 12 weeks\n13. Capable of understanding and complying with protocol requirements\n14. Signed and dated institutional review board (IRB)/independent ethics committee (IEC)-approved informed consent form (ICF) before any protocol-directed screening procedures are performed\n\nExclusion Criteria:\n\n1. Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment\n2. Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed\n3. Patient is a pregnant or lactating WOCBP\n4. Prior organ transplantation\n5. Patients with evidence of active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection. Patients with positive HBsAg and/or detectable HBV DNA are eligible only if adequately controlled on antiviral therapy according to institutional standards and liver function eligibility criteria are also met. HCV patients showing sustained viral response or patients with immunity to HBV infection may enroll.\n6. Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor\n7. History of primary malignancy other than the malignancy under study will be excluded, except for malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \\>90%). Prior malignancy history will be evaluated on a case-by-case basis by the Sponsor Medical Monitor.\n8. Symptomatic or uncontrolled central nervous system and brain metastasis or active leptomeningeal disease. Patients with equivocal findings or with confirmed brain metastases are eligible for the study provided that they are asymptomatic and radiologically and neurologically stable without the need for corticosteroid treatment or seizure prophylaxis for ≥4 weeks before the first dose of study drug. Prior treatment with either surgery or radiation is permitted and all patients with a history of CNS or brain lesions require imaging during screening to confirm stability.\n9. Other medical condition that in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:\n\n   * Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias\n   * QTc interval (using Fridericia correction calculation) \\> 480 msec","locations":[{"facility":"University of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"D&H Cancer Research Center","city":"Margate","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - Lake Nona","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - Sarasota","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Cancer & Blood Center","city":"Athens","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Wayne Medical Oncology and Hematology","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summit Cancer Center","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Natalie Warholic","phone":"617-500-8099","email":"CTX-8371-001@compasstherapeutics.com"}],"primaryOutcomes":["Cohort 1: Evaluate the safety and tolerability of escalating doses of CTX-8371","Cohort 1: Determine the dose(s) of CTX-8371 to be further examined in Cohort 2 and Phase 2 studies","Cohort 2: Evaluate the safety and tolerability of CTX-8371 at 3.0 mg/kg and 10.0 mg/kg"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","melanoma","lymphoma"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","palo-alto-california","margate-florida","orlando-florida","sarasota-florida","athens-georgia","fort-wayne-indiana","boston-massachusetts","buffalo-new-york","nashville-tennessee","spokane-washington"],"enrichment":{"headline":"Phase 1: testing CTX-8371 for Non Small Cell Lung Cancer","inPlainEnglish":"This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a this drug alone in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and Dose Expansion.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including","Malignant Melanoma (MM)","Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody","Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor","Uveal and mucosal melanoma are excluded","Head and Neck squamous cell carcinoma (HNSCC)"],"whoShouldSkip":["Developed clinically significant adverse reaction to PD-1 or PD-L1 therapy, including immune related adverse reactions, which led to discontinuation of treatment","Systemic therapy with immunosuppressive agents within 7 days before the start of CTX-8371 treatment. Topical, intranasal, intraocular, or inhaled corticosteroids and physiologic replacement for patients with adrenal insufficiency are allowed","Patient is a pregnant or lactating WOCBP","Prior organ transplantation","Active autoimmune disease or medical conditions requiring chronic steroid (i.e., \\> 10 mg/day prednisone or equivalent) or immunosuppressive therapy. Patients with a prior history of autoimmune disease may be eligible following discussion with the Medical Monitor","Other medical condition that in the opinion of the Investigator and/or Sponsor Medical Monitor may interfere with the conduct and/or interpretation of the current study, including:","Congestive heart failure (\\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest) or clinically significant cardiac arrhythmias"],"whatHappens":"If you join, the listed intervention(s) are CTX-8371. The registry lists allocation as randomized. This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a this drug alone in patients with metastatic or locally advanced malignancies.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 85 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.810Z"},{"nctId":"NCT06156683","title":"Kesimpta Pregnancy and Infant Safety Study Using Real World Data","officialTitle":"Kesimpta (Ofatumumab) Pregnancy and Infant Safety Study Using Real World Data","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The study is an observational retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.","conditions":["Multiple Sclerosis"],"keywords":["Kesimpta","ofatumumab","real world data"],"interventions":[{"type":"OTHER","name":"Multiple sclerosis disease modifying drug"}],"enrollment":1500,"startDate":"2024-06-30","completionDate":"2028-02-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe following overall criteria for study inclusion are applied:\n\n* Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period\n* Age 18-49 years at index date\n* A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources\n* Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date\n\nIn addition, the following outcome and objective specific inclusion criteria are applied:\n\n* For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth\n* For analyses of spontaneous abortion, elective termination of pregnancy, stillbirth, preeclampsia, eclampsia (secondary objectives): pregnancy ending in at least one live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy\n* For analyses of preterm birth, SGA (secondary objectives): pregnancy ending in at least one live birth\n* For analyses of MCMs among live births, spontaneous abortions, stillbirths, and elective terminations (exploratory objective): pregnancy ending in at least one live birth, spontaneous abortion, still birth, or elective termination\n* For analyses of neonatal infection: live newborn\n* For analyses of SII: newborn alive at 29 days after birth\n\nExclusion Criteria:\n\nThe following overall criteria for exclusion are applied:\n\n* Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance\n* Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance\n\nThe following outcome specific exclusion criteria are applied:\n\n* For analyses of MCMs and exploratory analyses of MCMs: pregnancies with a record of a chromosomal abnormality or a genetic syndrome\n* For analyses of preterm birth, pre-eclampsia, eclampsia and SGA, pregnancies involving multiples\n* For Kesimpta and MSDMD-exposed cohorts: pregnancies not exposed during the outcome specific risk period","locations":[{"facility":"Novartis Investigative Site","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Number of major congenital malformations (MCM) among live births"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["basel-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: Multiple sclerosis disease modifying drug for Multiple Sclerosis","inPlainEnglish":"The study is an watch-and-measure (no experimental treatment required) retrospective cohort study using longitudinal secondary data. Pregnant women with MS are assessed for exposure to Kesimpta and other MS disease modifying drugs (MSDMD) and followed up for adverse pregnancy and infant outcomes.","whoItsFor":["Ages 18 Years to any","Women only","The following overall criteria for study inclusion are applied:","Pregnancy with a recorded start and end of pregnancy outcome (live birth, spontaneous abortion, elective termination, stillbirth, or ectopic pregnancy) during the inclusion period","Age 18-49 years at index date","A diagnosis of MS before the index date. This inclusion criterion is based on diagnosis codes, as recorded in the different data sources","Availability of information on exposure to MSDMDs and maternal baseline characteristics for a minimum of 12 months before the index date","In addition, the following outcome and objective specific who can join are applied:","For analyses of MCMs in live births (primary objective): pregnancy ending in at least one live birth"],"whoShouldSkip":["The following overall criteria for exclusion are applied:","Pregnancy exposed to a MSDMD that have a known teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance","Pregnancy exposed to a non-MSDMD that have a known moderate to high teratogenic effect, determined based on the date of prescription, estimated supply duration, and the drug-specific window of clearance","The following outcome specific"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,500 people at Basel. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.279Z"},{"nctId":"NCT06159673","title":"ACP-204 in Adults With Alzheimer's Disease Psychosis","officialTitle":"A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"ACADIA Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with ADP\n\n* Substudy 1 (Phase 2) will evaluate efficacy and dose response of ACP-204 30 and 60 mg vs placebo. This substudy will be initiated first.\n* Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs placebo. Substudies 2A and 2B will be performed independently of each other and will commence after enrollment of Part 1.\n\nAll 3 substudies will be analyzed independently of each other.\n\nEach substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).","conditions":["Alzheimer's Disease Psychosis"],"keywords":["Alzheimer's disease psychosis","Hallucinations","Delusions"],"interventions":[{"type":"DRUG","name":"ACP-204"},{"type":"DRUG","name":"Placebo"}],"enrollment":1074,"startDate":"2023-11-14","completionDate":"2028-01","sex":"ALL","minAge":"55 Years","maxAge":"95 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting\n* Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria\n* Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)\n* Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD\n* Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD\n* Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association\n* MMSE score ≥6 and ≤24\n* Psychotic symptoms for at least 2 months\n* Lives in a stable place of residence and there are no plans to change living arrangements\n* Has a designated study partner/caregiver\n* Able to complete all study visits with a study partner/caregiver\n* Must be on a stable dose of cholinesterase inhibitor or memantine, if applicable\n\nExclusion Criteria:\n\n* Requires treatment with a medication prohibited by the protocol\n* Is in hospice and receiving end-of-life palliative care, or has become bedridden\n* Requires skilled nursing care\n* Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia\n* Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope\n* Atrial fibrillation\n* Symptomatic orthostatic hypotension\n* Protocol-defined exclusionary clinical laboratory findings\n* Treatment with anti-tau therapy or donanemab within 2 months prior to Screening\n\nAdditional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.","locations":[{"facility":"Chandler Clinical Trials","city":"Chandler","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Clinical Endpoint LLC","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center, Inc.","city":"Anaheim","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"ATP Clinical Research","city":"Costa Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Pain Medical Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute of Clinical Research","city":"Garden Grove","state":"California","country":"United 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Giglio","city":"Cefalù","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Neuromed Istituto Neurologico Mediterraneo","city":"Isernia","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Fondazione Policlinico Uni Campus Bio-Medico di Roma","city":"Roma","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Universitario Agostino Gemelli","city":"Roma","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"AOU Policlinico Umberto I","city":"Roma","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria OO. RR. S.","city":"Salerno","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Dipartimento di Neuroscienze Rita Levi Montalcini","city":"Torino","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Card. G. Panico","city":"Tricase","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Iecsi S.C.","city":"Monterrey","state":"N.L","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Dr. Jose Eleuterio Gonzalez","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Dr. Gonzalo Valdes Valdes","city":"Coahuila","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute S.C","city":"Estado de México","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"B&B Investigaciones Medicas SC","city":"Mazatlán","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Pharma Professional Research S.A. de C.V.","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mexico Centre for Clinical Research S.A de C.V","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Estudios Clínicos y Esp. Médicas SC CECEM","city":"Nuevo León","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"BIND Investigaciones S.C.","city":"San Luis Potosí City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurociencias Estudios Clinicos","city":"Sinaloa","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro para el Des de la Med y de Asist Med Esp SC","city":"Sinaloa","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Hosp Center Dr Dragisa Misovic Dedinje","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinical. Hospital Center Zvezdara","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mental Health","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Special Hospital for Cerebrovascular Disease Sveti Sava","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Clinic Centre of Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Special Hospital for Psychiatric Diseases","city":"Gornja Toponica","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Spl. Hosp. for Psychiatric Diseases Kovin","city":"Kovin","state":"","country":"Serbia","status":"TERMINATED","lat":null,"lon":null},{"facility":"Janjic University Clinical Center Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jovanovic University Clinical Centre of Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Nis","city":"Niš","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Spl. Hosp. for Psychiatric Diseases Sveti Vracevi","city":"Novi Kneževac","state":"","country":"Serbia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Gen. Hosp. Dr Radivoj Simonovic","city":"Sombor","state":"","country":"Serbia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"General Hospital Valjevo","city":"Valjevo","state":"","country":"Serbia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inha University Hospital","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eunpyeong St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Hanyang University Seoul Hospital","city":"Seoul","state":"","country":"South Korea","status":"TERMINATED","lat":null,"lon":null},{"facility":"Konkuk University Medical Center","city":"Seoul","state":"","country":"South Korea","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"SMG-SNU Boramae Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Provincial de Zamora","city":"Zamora","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"E-DA Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Medical University-Shuang Ho Hospital","city":"New Taipei City","state":"","country":"Taiwan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christine Murphy","phone":"858-465-7480","email":"cmurphy@acadia-pharm.com"},{"name":"Kristen White","phone":"813-838-6468","email":"kristen.white@acadia-pharm.com"}],"primaryOutcomes":["Scale for the Assessment of Positive Symptoms-Hallucinations and Delusions subscales (SAPS-H+D) total score change from baseline (Substudies 1, 2A, 2B)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["chandler-arizona","scottsdale-arizona","anaheim-california","costa-mesa-california","fresno-california","garden-grove-california","pasadena-california","aventura-florida","daytona-beach-florida","doral-florida","hialeah-florida","miami-florida","miami-beach-florida","miami-gardens-florida","miami-lakes-florida","orlando-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","elgin-illinois","shreveport-louisiana","gaithersburg-maryland","rochester-hills-michigan","st-louis-missouri","lincoln-nebraska","marlton-new-jersey","amherst-new-york","rochester-new-york","syracuse-new-york","the-bronx-new-york","beachwood-ohio","centerville-ohio","dayton-ohio","abington-pennsylvania","cypress-texas","houston-texas","pasadena-texas","stafford-texas","webster-texas","joinville-brazil","bras-lia-brazil","curitiba-brazil","passo-fundo-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","s-o-bernardo-do-campo-brazil","s-o-paulo-brazil","cherven-bryag-bulgaria","kardzhali-bulgaria","pazardzhik-bulgaria","pleven-bulgaria","plovdiv-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","antofagasta-chile","santiago-chile","kladno-czechia","prague-czechia","brno-czechia","choce-czechia","rychnov-nad-kn-nou-czechia","bron-france","colmar-france","dijon-france","limoges-france","lyon-france","paris-france","rouen-france","toulouse-france","tours-france","vand-uvre-l-s-nancy-france","brescia-italy","cefal-italy","isernia-italy","milan-italy","roma-italy","salerno-italy","torino-italy","tricase-italy","monterrey-mexico","coahuila-mexico","estado-de-m-xico-mexico","mazatl-n-mexico","mexico-city-mexico","nuevo-le-n-mexico","san-luis-potos-city-mexico","sinaloa-mexico","belgrade-serbia","gornja-toponica-serbia","kovin-serbia","kragujevac-serbia","ni-serbia","novi-kne-evac-serbia","sombor-serbia","valjevo-serbia","incheon-south-korea","seoul-south-korea","seville-spain","zamora-spain","kaohsiung-city-taiwan","new-taipei-city-taiwan","tainan-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 2 / Phase 3: testing ACP-204 for Alzheimer's Disease Psychosis","inPlainEnglish":"This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo). * Substudies 2A and 2B (both: Phase 3) will be confirmatory studies of either both doses (ACP-204 30 and 60 mg, respectively) or a single dose from Part 1 vs dummy treatment (placebo).","whoItsFor":["Ages 55 Years to 95 Years","Is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting","Meets clinical criteria for possible or probable AD based on the 2011 National Institute on Aging-Alzheimer Association (NIA-AA) criteria","Meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the International Psychogeriatrics Association (IPA)","Has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with AD","Has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of AD","Meets revised criteria for psychosis in major or mild neurocognitive disorder as per International Psychogeriatrics Association","MMSE score ≥6 and ≤24"],"whoShouldSkip":["Requires treatment with a medication prohibited by the protocol","Is in hospice and receiving end-of-life palliative care, or has become bedridden","Requires skilled nursing care","Psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia","Known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope","Atrial fibrillation","Symptomatic orthostatic hypotension"],"whatHappens":"If you join, the listed intervention(s) are ACP-204, or Placebo. The registry lists allocation as randomized. This is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group studies in patients with ADP * Substudy 1 (Phase 2) will evaluate how well it works and dose response of ACP-204 30 and 60 mg vs dummy treatment (placebo).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 1,074 people at 155 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.330Z"},{"nctId":"NCT06161506","title":"Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer","officialTitle":"A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nMen who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help.\n\nObjective:\n\nTo see if the Elidah device can reduce urinary incontinence after prostate treatment.\n\nEligibility:\n\nMen aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer.\n\nDesign:\n\nParticipants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests.\n\nThe Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis.\n\nParticipants will be given an Elidah device and taught how to use it at home.\n\nThey will use the device once a day for 20 minutes at a time; they will do this 5 days a week for 6 weeks.\n\nParticipants will complete a daily log. They will record the strength of electrical impulses (0-35); the number of incontinence episodes; the type of incontinence episode; and the number of used pads.\n\nParticipants will do a pad weight test. For 3 days before and 3 days after using the Elidah device, they will collect all of their used pads for each 24-hour period into a sealed plastic bag. They will also collect a second set of bags that contain dry versions of each product used.\n\nParticipants will have clinic visits after using the device for 3 weeks and after finishing the 6 weeks of treatment.\n\nParticipants will complete 15-minute questionnaires.","conditions":["Urinary Urge Incontinence","Stress Urinary Incontinence","Prostatic Hyperplasia"],"keywords":["Elidah Device","Urinary Incontinence","Prostate Cancer"],"interventions":[{"type":"DEVICE","name":"Elidah Device"}],"enrollment":41,"startDate":"2024-02-15","completionDate":"2027-12-01","sex":"MALE","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants must be male.\n* Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment.\n* Participants must have at least one of the following types of urinary incontinence:\n\n  * stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing\n  * urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer.\n* Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening.\n* Participants must be able to read and write in English.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<= 2.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Change of therapy for prostate cancer planned during the study intervention.\n* History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence.\n* Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (\\>= 4 UTIs within the 12 months prior to the study treatment initiation).\n* History of complete denervation of the pelvic floor.\n* Severe obesity (body mass index \\[BMI\\] \\>35).\n* Pelvic pain/painful bladder syndrome.\n* Metal implant in the abdominal or pelvic area.\n* History of chronic cough with ongoing symptoms\n* An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems.\n* History of epilepsy.\n* History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence.\n* Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation.\n* Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Debbie-Ann N Nathan, R.N.","phone":"(240) 858-3103","email":"dnathan@mail.nih.gov"},{"name":"Deborah E Citrin, M.D.","phone":"(240) 760-6206","email":"citrind@mail.nih.gov"}],"primaryOutcomes":["To describe the efficacy of the Elidah device treatment on male urinary incontinence"],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: Elidah Device for Urinary Urge Incontinence","inPlainEnglish":"Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surrounding tissues may help.","whoItsFor":["Ages 18 Years to 120 Years","Men only","Participants must be male","Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment","Participants must have at least one of the following types of urinary incontinence:","stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing","urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer","Participants must have moderate urinary incontinence defined as use of 1-4 pads per day by self-report at screening","Participants must be able to read and write in English"],"whoShouldSkip":["Change of therapy for prostate cancer planned during the study intervention","History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence","Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (\\>= 4 UTIs within the 12 months prior to the study treatment initiation)","History of complete denervation of the pelvic floor","Severe obesity (body mass index \\[body-mass index (BMI)\\] \\>35)","Pelvic pain/painful bladder syndrome","Metal implant in the abdominal or pelvic area"],"whatHappens":"If you join, the listed intervention(s) are Elidah Device. The registry lists allocation as na. Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 41 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.309Z"},{"nctId":"NCT06161519","title":"PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications","officialTitle":"Phase I/II Trial of PLX038 in Primary Central Nervous System Tumors With and Without MYC or MYCN Amplifications","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nAbout 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years. Many of these people have changes in certain genes (MYC or MYCN) that drive the development of their cancers.\n\nObjective:\n\nTo test a study drug (PLX038) in people with tumors of the brain or spinal cord.\n\nEligibility:\n\nPeople aged 18 years or older with a tumor of the brain or spinal cord. Some participants must also have tumors with changes in the MYC or MYCN genes.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam and blood tests. They will have imaging scans and a test of their heart function. They may need to have a biopsy: A sample of tissue will be removed from their tumor.\n\nPLX038 is given through a tube attached to a needle inserted into a vein in the arm. All participants will receive PLX038 on the first day of each 21-day treatment cycle. They will take a second drug 3 days later to help reduce the risk of infection; for this drug, participants will be shown how to inject themselves under the skin at home.\n\nBlood tests, imaging scans, and other tests will be repeated during study visits. Hair samples will also be collected during these visits. Some participants may have an additional biopsy.\n\nStudy treatment will continue up to 7 months.\n\nFollow-up visits will continue every few months for up to 5 years.","conditions":["Glioma","Medulloblastoma","Ependymoma","Glioblastoma"],"keywords":["Brain Tumors","Recurrent or progressive primary CNS tumors","Patient-Reported Outcomes","Spine Tumors","MYC or MYCN genes"],"interventions":[{"type":"DRUG","name":"PLX038"}],"enrollment":146,"startDate":"2024-01-31","completionDate":"2028-11-14","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:\n\n  * Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features.\n  * Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation.\n  * Cohort Phase IIB:\n\n    * Recurrent or progressive MYCN amplified ependymoma, OR\n    * Recurrent or progressive medulloblastoma with MYC or MYCN amplifications\n  * Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications.\n  * Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications.\n\nNOTE 1: Recurrence or progression may involve CNS, extra CNS, or both.\n\nNOTE 2: The presence of MYCN or MYC amplification must be confirmed by documented history. Participants who do not have documented history will be tested by NSR device (via next-generation sequencing panel TruSight(TM) Oncology 500) and the threshold of MYCN or MYC amplification for eligibility purposes is a fold change (FC) of \\>=2.5X (5 copies) with a minimum tumor content of 20%.\n\n* Participants must have archival tumor tissue (either a block or 15 formalin-fixed paraffin-embedded (FFPE) unstained slides) available for NCI LP review of MYC or MYCN amplification status (if necessary) and for correlative studies:\n\n  * Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID: tumor tissue obtained at any point before trial treatment initiation, but preferably from most recent surgical resection before study treatment initiation.\n  * Cohort Phase IIA: tumor tissue obtained at original diagnosis.\n* Participants in Cohort Phase IIA must have completed surgery followed by radiation at least 4 weeks and no more than 10 weeks from the last dose of radiation prior to study treatment initiation.\n* Participants in Cohorts Phase I, Phase IIB, Phase IIC, and Phase IID must have completed prior cytotoxic chemotherapy or radiation at least 4 weeks prior to study treatment initiation (at least 6 weeks if the last regimen included lomustine (CCNU) or carmustine (BCNU); at least 3 weeks if the last regimen included bevacizumab; at least 4 weeks if the last regimen included a checkpoint inhibitor or any other type of immunotherapy or cellular therapy; at least 5 half-lives if the last regimen included any investigational agent(s).\n* Age \\>= 18 years.\n* Karnofsky \\>= 70%. NOTE: Participants with severe paraparesis/paraplegia who need minimal assistance for self-care due to their motor deficit but are otherwise functionally independent will be eligible.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>=3,000/microliter\n  * absolute neutrophil count \\>1,500/microliter\n  * platelets \\>100,000/microliter\n  * hemoglobin \\>= 9 g/ dL (may be transfused within 2 weeks prior to treatment to achieve this level)\n  * total bilirubin within normal institutional limits\n  * aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \\<2.5 X institutional upper limit of normal (ULN)\n  * creatinine within normal institutional limits OR\n  * estimated glomerular filtrate rate (eGFR) using chronic kidney disease epidemiology collaboration) (CKD-EPI) equation:\\>= 60 mL/min/1.73 m\\^2 for participants with creatinine levels above institutional normal\n* Women of child-bearing potential (WOCBP) and those who can father children must agree to use effective contraception (barrier, hormonal contraception, intrauterine device (IUD), surgical sterilization, barrier at the study entry, for the duration of study treatment and up to 6 months (WOCBP) and 3 months (those who can father children) after the last dose of study treatment.\n* Breastfeeding participants must be willing to discontinue breastfeeding from study treatment initiation through 6 months after the last dose of the study drug.\n* Ability to self-report symptoms and physical function as determined by assessment of the clinical team performed at screening.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions to compounds of similar chemical composition to PLX038.\n* Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges).\n* Participants who require treatment with strong inhibitors or inducers of CYP3A or with UGT1A1 inhibitors during the planned period of investigational treatment with PLX038. Lists including medications and substances known or with the potential to interact with CYP3A or UGT1A1 are provided in https://drug-interactions.medicine.iu.edu/maintable.\n* History of treatment with pegylated topoisomerase inhibitors.\n* Has unresolved or persistent grade 2 or higher GI toxicity from any type of RT at screening\n* Participants with history of homozygous for the UGT1A1\\*28 variant allele with severely reduced UGT1A1 activity.\n* Participants positive for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV).\n* Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening).\n* Participants unable to have MRIs.\n* Prior or concurrent malignancy unless its natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen (https://deainfo.nci.nih.gov/advisory/ctac/1117/4-JournalClinicalOncology.pdf, https://ctep.cancer.gov/protocolDevelopment/docs/CTEP\\_Broadened\\_Eligibility\\_Criteria\\_Guidance.pdf)\n* Uncontrolled intercurrent illness evaluated by history, weight, and physical exam that would limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI NOB Referral Group","phone":"(866) 251-9686","email":"ncinobreferrals@mail.nih.gov"},{"name":"Kevin A Camphausen, M.D.","phone":"(240) 760-6205","email":"camphauk@mail.nih.gov"}],"primaryOutcomes":["Phase I: To confirm the RP2D of PLX038 in participants with progressive or recurrent primary CNS tumors","Phase II: To assess the efficacy of PLX038 at RP2D in primary CNS tumors containing MYC or MYCN amplifications"],"hasResults":false,"conditionSlugs":["glioblastoma","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing PLX038 for Glioma","inPlainEnglish":"Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States. Most of these tumors are benign; however, about 30% are malignant, and 35% of people with malignant tumors in the brain and spinal cord will die within 5 years.","whoItsFor":["Ages 18 Years to 120 Years","Participants must have documented pathologic diagnosis of confirmed primary central nervous system (CNS) tumor with one of the below diagnoses:","Cohort Phase I: Any recurrent or progressive primary CNS tumor, regardless of molecular features","Cohort Phase IIA: Newly diagnosed MYCN amplified ependymoma after surgery and radiation","Recurrent or progressive MYCN amplified ependymoma, OR","Recurrent or progressive medulloblastoma with MYC or MYCN amplifications","Cohort Phase IIC: Any other recurrent or progressive primary CNS tumor with MYC or MYCN amplifications","Cohort Phase IID: Any recurrent glioblastoma without MYC or MYCN amplifications"],"whoShouldSkip":["History of allergic reactions to compounds of similar chemical composition to PLX038","Major surgery within 2 weeks prior to study treatment initiation. NOTE: The surgery is considered major if a mesenchymal barrier is opened (pleural cavity, peritoneum, meninges)","History of treatment with pegylated topoisomerase inhibitors","Has unresolved or persistent grade 2 or higher GI toxicity from any type of RT at screening","Participants with history of homozygous for the UGT1A1\\*28 variant allele with severely reduced UGT1A1 activity","Participants positive for Human immunodeficiency virus (HIV), Hepatitis C virus (HCV), and Hepatitis B virus (HBV)","Pregnancy (confirmed with beta human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening)"],"whatHappens":"If you join, the listed intervention(s) are PLX038. The registry lists allocation as randomized. Background: About 90,000 new cases of brain and spinal cord tumors are diagnosed annually in the United States.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 146 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.474Z"},{"nctId":"NCT06170788","title":"Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)","officialTitle":"A Randomized, Open-label, Phase 3 Study of MK-2870 in Combination With Pembrolizumab Compared to Pembrolizumab Monotherapy in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS Greater Than or Equal to 50% (TroFuse-007)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.","conditions":["Non-small Cell Lung Cancer (NSCLC)"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)"],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Supportive care measures"}],"enrollment":614,"startDate":"2023-12-15","completionDate":"2028-01-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC\n\n  * Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy\n  * Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory\n  * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.\n  * A life expectancy of at least 3 months.\n  * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.\n* Has Grade ≥2 peripheral neuropathy.\n* History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.\n* Received prior systemic anticancer therapy for their metastatic NSCLC.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.\n* Received radiation therapy to the lung that is \\>30 Gy within 6 months of start of study intervention.\n* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.\n* Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.\n* Active autoimmune disease that has required systemic treatment in the past 2 years.\n* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.\n* Active infection requiring systemic therapy\n* Concurrent active Hepatitis B and Hepatitis C virus infection.\n* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* History of allogeneic tissue/solid organ transplant.\n* Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.","locations":[{"facility":"Mayo Clinic in Arizona - Phoenix ( Site 0147)","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)","city":"Grand Junction","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106)","city":"Marietta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The University of Louisville, James Graham Brown Cancer Center ( Site 0121)","city":"Louisville","state":"Kentucky","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"New England Cancer Specialists ( Site 0143)","city":"Westbrook","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Massachusetts Chan Medical School-Division of Hematology/Oncology ( Site 0144)","city":"Worcester","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester ( Site 0148)","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hattiesburg Clinic Hematology/Oncology ( Site 0104)","city":"Hattiesburg","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center ( Site 0119)","city":"Cleveland","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)","city":"Corvallis","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants P.A. ( Site 0129)","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0306)","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Británico de Buenos Aires-Oncology ( Site 0304)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Privado de RMI Río Cuarto S.A. II ( Site 0310)","city":"Río Cuarto","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncología de Rosario ( Site 0301)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Aleman-Oncology ( Site 0300)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Port Macquarie - Mid North Coast Cancer Institute-Medical Oncology ( Site 3002)","city":"Port Macquarie","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westmead Hospital ( Site 3000)","city":"Westmead","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grampians Health-Medical Oncology ( Site 3001)","city":"Ballarat Central","state":"Victoria","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northern Hospital ( Site 3003)","city":"Epping","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula University Hospital ( Site 3004)","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0409)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Viver ( Site 0400)","city":"Santa Maria","state":"Rio Grande do Sul","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0402)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0406)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Câncer - INCA ( Site 0405)","city":"Rio de Janeiro","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0401)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"William Osler Health System ( Site 0203)","city":"Brampton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trillium Health Partners - Credit Valley Hospital ( Site 0202)","city":"Mississauga","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre ( Site 0200)","city":"Montreal","state":"Quebec","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Clinica Universidad Catolica del Maule-Oncology ( Site 0501)","city":"Talca","state":"Maule Region","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlandi Oncologia-Oncology ( Site 0504)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"FALP-UIDO ( Site 0509)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill-Clinical Area ( Site 0507)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradford Hill Norte ( Site 0516)","city":"Antofagasta","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Second Affiliated hospital of Anhui Medical University ( Site 3133)","city":"Hefei","state":"Anhui","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Beijing Cancer hospital-intrathoratic deparmtment II ( Site 3101)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Peking Union Medical College Hospital-pneumology department ( Site 3100)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fujian Provincial Cancer Hospital ( Site 3131)","city":"Fuzhou","state":"Fujian","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated hospital of Xiamen University-Breast Surgery ( Site 3107)","city":"Xiamen","state":"Fujian","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Guangzhou Medical University ( Site 3134)","city":"Guangzhou","state":"Guangdong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3108)","city":"Guangzhou","state":"Guangdong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Guangdong Medical University ( Site 3123)","city":"Zhanjiang","state":"Guangdong","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Second Hospital of Hebei Medical University ( Site 3135)","city":"Shijiazhuang","state":"Hebei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Harbin Medical University Cancer Hospital-oncology of department ( Site 3132)","city":"Harbin","state":"Heilongjiang","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital ( Site 3116)","city":"Zhengzhou","state":"Henan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Tongji Hospital Tongji Medical,Science & Technology ( Site 3117)","city":"Wuhan","state":"Hubei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Wuhan Union Hospital ( Site 3130)","city":"Wuhan","state":"Hubei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital ( Site 3106)","city":"Wuhan","state":"Hubei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Xiangyang Central Hospital-oncology department ( Site 3136)","city":"Xiangyang","state":"Hubei","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University ( Site 3138)","city":"Changsha","state":"Hunan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital ) ( Site 3113)","city":"Wuxi","state":"Jiangsu","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Xuzhou Medical College ( Site 3112)","city":"Xuzhou","state":"Jiangsu","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 3127)","city":"Nanchang","state":"Jiangxi","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 3121)","city":"Nanchang","state":"Jiangxi","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Provincial Cancer Hospital ( Site 3143)","city":"Nanchang","state":"Jiangxi","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jilin Province Tumor Hospital-oncology department ( Site 3126)","city":"Changchun","state":"Jilin","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital-oncology department ( Site 3122)","city":"Jinan","state":"Shandong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Shandong Cancer Hospital ( Site 3119)","city":"Jinan","state":"Shandong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Changhai Hospital ( Site 3125)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University ( Site 3124)","city":"Chengdu","state":"Sichuan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer hospital. 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(OS)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["phoenix-arizona","burbank-california","grand-junction-colorado","jacksonville-florida","marietta-georgia","louisville-kentucky","westbrook-maine","worcester-massachusetts","minneapolis-minnesota","rochester-minnesota","hattiesburg-mississippi","reno-nevada","cleveland-ohio","corvallis-oregon","houston-texas","ciudad-aut-noma-de-buenos-aires-argentina","buenos-aires-argentina","r-o-cuarto-argentina","rosario-argentina","port-macquarie-australia","westmead-australia","ballarat-central-australia","epping-australia","frankston-australia","porto-alegre-brazil","santa-maria-brazil","barretos-brazil","s-o-jos-do-rio-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","brampton-canada","mississauga-canada","montreal-canada","talca-chile","santiago-chile","antofagasta-chile","hefei-china","beijing-china","fuzhou-china","xiamen-china","guangzhou-china","zhanjiang-china","shijiazhuang-china","harbin-china","zhengzhou-china","wuhan-china","xiangyang-china","changsha-china","wuxi-china","xuzhou-china","nanchang-china","changchun-china","jinan-china","shanghai-china","chengdu-china","neijiang-china","kunming-china","hangzhou-china","taizhou-china","bogot-colombia","monter-a-colombia","pereira-colombia","ostrava-czechia","pardubice-czechia","prague-czechia","olomouc-czechia","herning-denmark","aalborg-denmark","odense-c-denmark","marseille-france","montpellier-france","limoges-france","nancy-france","bayonne-france","villefranche-sur-sa-ne-france","amiens-france","poitiers-france","m-nchen-germany","nuremberg-germany","marburg-germany","hanover-germany","moers-germany","m-nster-germany","mainz-germany","gro-hansdorf-germany","gera-germany","berlin-germany","bari-italy","meldola-italy","udine-italy","milan-italy","bergamo-italy","catanzaro-italy","florence-italy","roma-italy","toyoake-japan","hirosaki-japan","kashiwa-japan","matsuyama-japan","fukuoka-japan","kurume-japan","ta-japan","himeji-japan","shiwa-gun-japan","kawasaki-japan","yokohama-japan","matsusaka-japan","sendai-japan","hirakata-japan","takatsuki-japan","ureshino-japan","niigata-japan","suntogun-japan","shimotsugagun-japan","bunkyo-japan","koto-japan","ta-ku-japan","shinjuku-japan","ube-japan","kumamoto-japan","osaka-japan","guadalajara-mexico","mexico-city-mexico","monterrey-mexico","san-luis-potos-city-mexico","oaxaca-city-mexico","puebla-city-mexico","breda-netherlands","tilburg-netherlands","zwolle-netherlands","arequipa-peru","surquillo-peru","lima-peru","bydgoszcz-poland","grudzi-dz-poland","torun-poland","krakow-poland","warsaw-poland","przemy-l-poland","olsztyn-poland","lodz-poland","lisbon-portugal","funchal-portugal","vila-nova-de-gaia-portugal","w-nju-south-korea","goyang-si-south-korea","suwon-south-korea","cheongju-si-south-korea","daegu-south-korea","seoul-south-korea","jerez-de-la-frontera-spain","a-coru-a-spain","pozuelo-de-alarc-n-spain","m-laga-spain","valencia-spain","barcelona-spain","madrid-spain","santa-cruz-de-tenerife-spain","seville-spain","tainan-taiwan","taipei-city-taiwan","hsinchu-taiwan","kaohsiung-city-taiwan","new-taipei-city-taiwan","taichung-taiwan","taipei-taiwan","bangkok-thailand","pathumwan-thailand","muang-thailand","stanbul-turkey-t-rkiye","bornova-turkey-t-rkiye","talas-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","denizli-turkey-t-rkiye","istanbul-turkey-t-rkiye","samsun-turkey-t-rkiye","london-united-kingdom","portsmouth-united-kingdom","canterbury-united-kingdom","central-middlesbrough-united-kingdom","hanoi-vietnam","ho-chi-minh-vietnam","h-n-i-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 3: testing Sacituzumab tirumotecan for Non-small Cell Lung Cancer (NSCLC)","inPlainEnglish":"The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC","Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy","Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory","An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization","A life expectancy of at least 3 months","Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"],"whoShouldSkip":["Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements","Has Grade ≥2 peripheral neuropathy","History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention","Received prior systemic anticancer therapy for their metastatic NSCLC","Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization"],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Pembrolizumab, or Supportive care measures. The registry lists allocation as randomized. The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 614 people at 220 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.672Z"},{"nctId":"NCT06174987","title":"A Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)","officialTitle":"A Master Rollover Study to Provide Continued Access to and Assess Long-Term Safety of the Study Drug(s)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study.","conditions":["Advanced Cancer","Metastatic Cancer"],"keywords":["Advanced cancer","Metastatic cancer","T-DXd","DS8201a"],"interventions":[{"type":"DRUG","name":"T-DXd"}],"enrollment":75,"startDate":"2024-01-05","completionDate":"2028-02-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment into the study:\n\n1. Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition.\n2. No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s).\n3. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug.\n\n   a. If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug.\n4. Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration.\n5. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening, and throughout the Treatment Period in the compound-specific sub-protocol and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Participants who permanently discontinued from the study drug in the parent study.\n2. Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject.\n3. Local access to commercially available drug at no cost to the subject as permitted by local/country regulation.","locations":[{"facility":"Research Facility","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Durham","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Bedford Park","state":"","country":"Australia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Itajaí","state":"","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Rio de Janeiro","state":"","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"São Paulo","state":"","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Changchun","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Harbin","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Lille","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Marseille","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Toulouse","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Villejuif","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Hong Kong","state":"","country":"Hong Kong","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Petah Tikva","state":"","country":"Israel","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Aviano","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Milan","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Rozzano","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Chūōku","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Kashiwa-shi","state":"","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Daegu","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Goyang-si","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Seoul","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"A Coruña","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Barcelona","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Madrid","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Tainan","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Taipei","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Antalya","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Diyarbakır","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Research Facility","city":"Tekirdağ","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daiichi Sankyo Contact for Clinical Trial Information","phone":"908-992-6400","email":"CTRinfo_us@daiichisankyo.com"}],"primaryOutcomes":["Number of Participants Reporting Treatment-emergent Adverse Events Leading to Study Drug discontinuation and/or Dose Reduction, Treatment-emergent Serious Adverse Events (TESAEs), and Treatment-emergent Adverse Events of Special Interest (AESIs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["miami-florida","durham-north-carolina","bedford-park-australia","itaja-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","changchun-china","harbin-china","hefei-china","lille-france","marseille-france","toulouse-france","villejuif-france","hong-kong-hong-kong","petah-tikva-israel","aviano-italy","milan-italy","rozzano-italy","ch-ku-japan","kashiwa-shi-japan","daegu-south-korea","goyang-si-south-korea","seoul-south-korea","a-coru-a-spain","barcelona-spain","madrid-spain","tainan-taiwan","taipei-taiwan","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","diyarbak-r-turkey-t-rkiye","istanbul-turkey-t-rkiye","tekirda-turkey-t-rkiye"],"enrichment":{"headline":"Phase 3: testing T-DXd for Advanced Cancer","inPlainEnglish":"This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc. (DS) or DS/Astra Zeneca (AZ)-sponsored study.","whoItsFor":["Ages 18 Years to any","Participants must meet all of the following criteria to be eligible for enrollment into the study:","Currently enrolled in a DS or DS/AZ-sponsored parent study that has met EOS definition","No evidence of progressive disease at screening and determined to have investigator-assessed clinical benefit from continued treatment with a DS or DS/AZ alliance study drug(s)","Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug","a. If the participant is a female of childbearing potential, she must have a negative urine pregnancy test at Screening, during the Treatment Period, and for 7 months, following the last dose of study drug","Male subjects must not freeze or donate sperm starting at Screening, throughout the study period, and at least 4 months after the final study drug administration"],"whoShouldSkip":["Participants who meet any of the following criteria will be disqualified from entering the study:","Participants who permanently discontinued from the study drug in the parent study","Any AE, laboratory abnormality, or intercurrent illness that, in the opinion of the investigator, indicates study participation is not in the best interest of the subject","Local access to commercially available drug at no cost to the subject as permitted by local/country regulation"],"whatHappens":"If you join, the listed intervention(s) are T-DXd. The registry lists allocation as na. This open-label, multicenter, rollover study will provide continued treatment for participants deriving benefit from different therapies received in studies sponsored by Daiichi Sankyo, Inc.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 75 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.347Z"},{"nctId":"NCT06180382","title":"Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.","officialTitle":"Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration: A Randomized, Multicentre, Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Centre Hospitalier Universitaire de Saint Etienne","sponsorClass":"OTHER","summary":"A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class. Moreover, according to STRIDE 2 recommendations and CALM study, optimize patients based solely on lack of biological remission (CRP, calprotectin) can be discuss. If CALM study has showed that the intervention arm based on regular monitoring fecal calprotectin, CRP and/or CDAI to optimize patients under adalimumab was significantly associated to an increase rate of mucosal healing that the standard of care strategy based on only clinical activity, TDM was not available to guide drug optimization strategy.","conditions":["Crohn's Disease"],"keywords":["Crohn's disease","Adalimumab","Vedolizumab","therapeutic strategy","Efficacy","biomarker"],"interventions":[{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Vedolizumab"}],"enrollment":220,"startDate":"2024-10-31","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Major patient and having given consent to participate in the study\n* Patients with Crohn's disease who have responded primary to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks).\n* Patient affiliated to or entitled under a social security scheme\n\nExclusion Criteria:\n\n* Pregnant woman\n* Patient unable to perform MRI or VCE or ileocolonoscopy or ultrasound less than one month before inclusion\n* Previous or current use of vedolizumab or ustekinumab for Crohn's disease or participation in a biological study\n* Concomitant use of immunomodulators\n* Patients on corticosteroid therapy\n* History of cancer\n* History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections\n* Patient with ileoanal pouchitis or ileorectal anastomosis\n* Patient with short small bowel syndrome as determined by investigator\n* Patients receiving total parenteral nutrition (TPN)\n* Patients receiving enteral nutrition\n* Patient under legal protection or unable to give consent\n* Hemorrhagic rectocolitis or indeterminate colitis\n* Patients treated with concomitant immunosuppressive agents\n* Patient treated with an optimized dose of adalimumab\n* Primary non-responder to Adalimumab\n* Patient previously treated with infliximab or ustekinumab before adalimumab\n* Severe relapse defined by CDAI \\> 330\n* Patient with anoperineal Crohn's disease\n* Crohn's disease patient with transient or permanent stoma.","locations":[{"facility":"APHP - Hôpital Bicêtre","city":"Le Kremlin-Bicêtre","state":"PARIS","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Amiens","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu Limoges","city":"Limoges","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"APHM","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Montpellier","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital de l'Archet II","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assistance Publique - Hôpitaux de Paris","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Bordeaux","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ch Lyon Sud","city":"Pierre-Bénite","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Rennes","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Saint-Etienne","city":"Saint-Etienne","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mathilde BARRAU, MD","phone":"(0)477829626","email":"mathilde.barrau@chu-st-etienne.fr"},{"name":"Sandra COURNIER, project manager","phone":"(0)477127652","email":"sandra.cournier@chu-st-etienne.fr"}],"primaryOutcomes":["ADA optimized versus Vedolizumab as second line"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["le-kremlin-bic-tre-france","amiens-france","lille-france","limoges-france","marseille-france","montpellier-france","nice-france","paris-france","pessac-france","pierre-b-nite-france","rennes-france","saint-etienne-france"],"enrichment":{"headline":"Phase 4: testing Adalimumab for Crohn's Disease","inPlainEnglish":"A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy. The optimal intervention in patients with secondary loss-of-response (LOR) is still poorly defined, as there are still scant data on how best to choose the next intervention from among dose-intensification, switch to another anti-TNF or switch out of the anti-TNF class.","whoItsFor":["Ages 18 Years to any","Major patient and having given consent to participate in the study","Patients with Crohn's disease who have responded primary to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks)","Patient affiliated to or entitled under a social security scheme"],"whoShouldSkip":["Patient unable to perform MRI or VCE or ileocolonoscopy or ultrasound less than one month before inclusion","Previous or current use of vedolizumab or ustekinumab for Crohn's disease or participation in a biological study","Concomitant use of immunomodulators","Patients on corticosteroid therapy","Patient with ileoanal pouchitis or ileorectal anastomosis","Patient with short small bowel syndrome as determined by investigator","Patients receiving total parenteral nutrition (TPN)"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab, or Vedolizumab. The registry lists allocation as randomized. A substantial fraction of IBD patients with an initial response to infliximab or adalimumab later experience re-emerging active disease despite ongoing anti-Tumour Necrosis Factor (TNF) agents maintenance therapy.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 220 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.272Z"},{"nctId":"NCT06188689","title":"Evaluation of A Clinical Diagnostic Test for CRDS","officialTitle":"Evaluation of a Clinical Diagnostic Test for Calcium Release Deficiency Syndrome: The DIAGNOSE CRDS Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Population Health Research Institute","sponsorClass":"OTHER","summary":"Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function. We hypothesize that CRDS can be diagnosed clinically through evaluation of the repolarization response to brief tachycardia, mediated by cardiac pacing, and a subsequent pause.","conditions":["Calcium Release Deficiency Syndrome (CRDS)"],"keywords":["cardiac arrhythmia, sudden cardiac death, cardiac ryanodine receptor, unexplained cardiac arrest"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Pacing"}],"enrollment":400,"startDate":"2023-02-02","completionDate":"2027-12","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Cohort 1: Calcium Release Deficiency Syndrome (CRDS) Cases\n\nInclusion criteria:\n\n• Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing\n\nExclusion criteria:\n\n• Unable to provide informed consent\n\nCohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases\n\nInclusion criteria:\n\n* Satisfy a clinical phenotype consistent with the Expert Consensus Statement\n* Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic/pathogenic CASQ2 variants\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Use of a QT prolonging medication, aside from flecainide, at the time of the burst pacing maneuvers\n\nCohort 3: Survivors of Unexplained Cardiac Arrest (UCA)\n\nInclusion criteria:\n\n* Cardiac arrest requiring cardioversion or defibrillation that remains unexplained following an ECG, echocardiogram, coronary assessment, cardiac MRI, and exercise treadmill test\n* Undergone genetic testing that includes screening of RyR2\\*\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Use of a QT prolonging medication at the time of the burst pacing maneuvers\n\n  * Among survivors of UCA that possess a rare RyR2 variant in the absence of a CPVT phenotype, in vitro functional testing will be performed in order to confirm it is not loss- or gain-of-function (and will be arranged through the laboratory of Dr. Wayne Chen at the University of Calgary).\n\nCohort 4: SVT controls\n\nInclusion criteria:\n\n• Undergoing an invasive electrophysiology study\n\nExclusion criteria:\n\n* Ventricular cardiomyopathy\n* Ventricular pre-excitation\n* Long QT syndrome\n* Use of a QT prolonging medication at the time of the EP study\n* Use of a Class I or Class III anti-arrhythmic drug at the time of the EP study\n* Known obstructive coronary artery disease (existing coronary stenosis \\>50%)\n* Unable to provide informed consent","locations":[{"facility":"University of California","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antwerp University Hospital","city":"Edegem","state":"Antwerp","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Brussel","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Health Services","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's & Women's Health Centre of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamilton General Hospital","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - University Hospital","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ottawa Heart Institute","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto General Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montréal Heart Institute","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aarhus University Hospital","city":"Aarhus","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Bordeaux","city":"Bordeaux","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital","city":"London","state":"London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals","city":"Oxford","state":"Oxfordshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jason Roberts, MD MAS","phone":"905-297-3479","email":"jason.roberts@phri.ca"}],"primaryOutcomes":["ΔT-wave amplitude value","ΔQT value"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["san-francisco-california","boston-massachusetts","rochester-minnesota","seattle-washington","edegem-belgium","brussels-belgium","calgary-canada","edmonton-canada","vancouver-canada","hamilton-canada","london-canada","ottawa-canada","toronto-canada","montreal-canada","qu-bec-canada","aarhus-denmark","bordeaux-france","jerusalem-israel","london-united-kingdom","oxford-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Pacing for Calcium Release Deficiency Syndrome (CRDS)","inPlainEnglish":"Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death. Diagnosis of CRDS presently requires cellular-based in vitro confirmation that an RyR2 variant causes loss-of-function.","whoItsFor":["Cohort 1: Calcium Release Deficiency Syndrome (CRDS) Cases","Presence of an RyR2 variant confirmed to be loss-of-function on in vitro testing"],"whoShouldSkip":["Cohort 2: Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) Cases","who can join:","Satisfy a clinical phenotype consistent with the Expert Consensus Statement","Presence of a confirmed or presumed pathogenic gain-of-function RyR2 variant OR homozygous or compound heterozygous for likely pathogenic/pathogenic CASQ2 variants"],"whatHappens":"If you join, the listed intervention(s) are Pacing. The registry lists allocation as na. Calcium Release Deficiency Syndrome (CRDS) is a novel inherited arrhythmia syndrome secondary to RyR2 loss-of-function that confers a risk of sudden cardiac death.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at 21 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.017Z"},{"nctId":"NCT06192563","title":"A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment","officialTitle":"A Prospective Observational Study of Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions (Eczema Area and Severity Index Score < 16 for Adolescents and < 21 for Children) Receiving Dupilumab","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated. Further data about the effectiveness of dupilumab in adolescent and children participants with moderate to mild EASI score and severe itching and/or localized AD to better understand the potential clinical benefits of dupilumab in these populations.\n\nThe main objective of the study us to assess the real-word effectiveness and safety of dupilumab in pediatric patients (age 6 months-17 years) who suffer from severe AD with EASI score \\< 16 for adolescents (age 12-17 years) and \\< 21 for children (age 6 months-11 years), and who are eligible for systemic therapy according to Italian reimbursement criteria.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"}],"enrollment":230,"startDate":"2023-11-30","completionDate":"2028-03-31","sex":"ALL","minAge":"6 Months","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female, aged between 6 months and 17 years at the baseline visit.\n* Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:\n\n  \\-- Adolescents (12 to 17 years old) with EASI \\< 16 and children (6 months to 11 years of age) with EASI \\< 21 and.\n  1. Children's Dermatology Life Quality Index (cDLQI)\\* ≥ 10 and / or\n  2. Itch NRS ≥ 7 and / or\n  3. Localization in visible or sensitive areas (head/neck/hands or genitals)\n* Participants/ caregivers able to understand and complete study-related questionnaires.\n* Provided signed informed consent or parental/legally acceptable representative consent and participant assent where applicable.\n\n  * Only for adolescents and children 6-11 years of age.\n\nExclusion Criteria:\n\n* Use of dupilumab within 6 months prior to study entry.\n* Participants currently participating in any interventional clinical trial that modifies patient care.\n* Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse).\n\nThe above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number: 002","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 006","city":"Brescia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 004","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 001","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 010","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 011","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 005","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 009","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 014","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Children and Adolescents: Percentage (%) change from baseline in Eczema Area and Severity Index (EASI) score","Children and Adolescents: Percentage (%) of participants with EASI-50","Children and Adolescents: Percentage (%) of participants with EASI-75","Children and Adolescents: Percentage (%) of participants with EASI-90","Children and Adolescents: Change from baseline in Patient Oriented Eczema Measure (POEM) score","Children and Adolescents: Percentage (%) of children (6-11 years) and adolescents with a ≥ 6-point improvement from baseline in POEM score","Children and Adolescents: Percentage of Infants (6 months-5 years) with a ≥ 3-point Improvement From Baseline in POEM score","Children and Adolescents: Percentage (%) of participants with adverse events","Children only: Mean Absolute Change from Baseline in Scoring Atopic Dermatitis (SCORAD) Total Score","Children only: Percentage Change from Baseline in SCORAD","Adolescents: Percentage (%) change from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) at 4, 16, 52 weeks","Adolescents: Participant assessment: Percentage (%) of participants with a ≥4-point improvement from baseline in PP-NRS at 4, 16, 52 weeks","Adolescents: Percentage (%) of participants with a PP-NRS score of 0, 1 to 3, and 4 to 6 at 4, 16, 52 weeks (only patients with baseline PP-NRS ≥ 7","Children: Absolute Change from Baseline in SCORAD itch VAS","Children: Percentage of Patients with Mild or no Itch (SCORAD itch VAS < 4)","Adolescents: Percentage (%) change from baseline in Sleep Disturbance Numerical Rating Scale (SD-NRS) at 4, 16, 52 weeks","Children: Mean Absolute Change from Baseline in SCORAD sleep VAS","Children: Percentage Change from Baseline in SCORAD Sleep VAS","Adolescents: Percentage (%) change from baseline in Children's Dermatology Life Quality Index (CDLQI) at 4, 16, 52 weeks","Adolescents: Percentage (%) of participants who achieve a ≥6-point reduction from baseline in CDLQI score at 4, 16, 52 weeks","Adolescents: Percentage of Participants with cDLQI Score of 0-1","Adolescents: Percentage (%) of Participants with CDLQI Score of < 6 at 4, 16, 52 weeks (only patients with CDLQI ≥ 10 at baseline)","Children: Mean Absolute Change from Baseline cDLQI / Infants' Dermatitis Quality of Life Index (iDQoL) (for patients ˂ 4 years of age)","Children: Percentage of Participants who Achieve a ≥ 6-point Reduction from Baseline in cDLQI / iDQoL (for patients ˂ 4 years of age)","Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) Score of 0-1","Children: Percentage of Participants with cDLQI / iDQoL (for patients ˂ 4 years of age) score < 6","Adolescents: Percentage (%) change from baseline in Hospital Anxiety and Depression Scale (HADS) at 4, 16, 52 weeks","Children: Percentage (%) Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score","Adolescents: Percentage (%) change from baseline Atopic Dermatitis Control Tool (ADCT) score at 4, 16, 52 weeks","Adolescents: Participant assessment: Percentage (%) of participants with ADCT < 7 at 4, 16, 52 weeks","Children and Adolescents: Percentage (%) change from baseline the Dermatitis Family Impact (DFI) questionnaire at 4, 16, 52 weeks","Children and Adolescents: Percentage (%) of Participants with Physician's Global Assessment (PGA) Face 0 or (/) 1, PGA Feet 0/1, PGA Hands 0/1, PGA Genitals 0/1 and at least a 2-point Improvement from Baseline","Adolescents: Percentage (%) of Participants with PGA Genitals 0/1 and at least a 2-point Improvement from Baseline","Children and Adolescents: Time to Discontinuation and Reasons for Discontinuation","Mean Time to First TCS/TCI Discontinuation.","Children: Percentage of Patients that Discontinue Topical Corticosteroids (TCS) and Topical Calcineurin Inhibitors (TCI)","Adolescents: Participant assessment: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM-9) score at 4, 16, 52 weeks","Adolescents: Percentage (%) change from baseline in Asthma Control Questionnaire (ACQ-6) at 4, 16, 52 weeks in participants with concomitant asthma","Children: Mean Absolute Change from Baseline in Pediatric Asthma Questionnaire (PAQ)","Children: Percentage Change from Baseline in Pediatric Asthma Questionnaire (PAQ)","Children and Adolescents: Percentage (%) change from baseline in Total Nasal Symptoms Score (TNSS) at 4, 16, 52 weeks in participants with concomitant chronic rhinitis"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["bologna-italy","brescia-italy","florence-italy","milan-italy","naples-italy","roma-italy","verona-italy"],"enrichment":{"headline":"Not a traditional drug phase: testing Dupilumab for Atopic Dermatitis","inPlainEnglish":"In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile. In these clinical trials, only patients with Eczema Area and Severity Index (EASI) score greater than or equal to (≥) 16 were enrolled, and effectiveness on sensitive/visible areas was not specifically evaluated.","whoItsFor":["Ages 6 Months to 17 Years","Male or female, aged between 6 months and 17 years at the baseline visit","Patients with AD who have been prescribed dupilumab as per clinical practice (according to AIFA reimbursement policy) and who fulfill the following criteria:","\\-- Adolescents (12 to 17 years old) with EASI \\< 16 and children (6 months to 11 years of age) with EASI \\< 21 and","Children's Dermatology Life Quality Index (cDLQI)\\* ≥ 10 and / or","Itch NRS ≥ 7 and / or","Localization in visible or sensitive areas (head/neck/hands or genitals)","Only for adolescents and children 6-11 years of age"],"whoShouldSkip":["Use of dupilumab within 6 months prior to study entry","Participants currently participating in any treatment clinical trial that modifies patient care","Any condition that, in the opinion of the Investigator, may interfere with participant's ability to participate in the study (e.g., substance abuse)","The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 230 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.711Z"},{"nctId":"NCT06200155","title":"Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","officialTitle":"TRIP - TReatment to Improve Depression and/or Anxiety Using Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.","conditions":["Depression, Anxiety","Psilocybin-Assisted Psychotherapy","Advanced Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"OTHER","name":"Niacin"}],"enrollment":48,"startDate":"2024-04-16","completionDate":"2026-12-31","sex":"ALL","minAge":"25 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants must have one of the following histology documented tumor types: non-small cell lung carcinoma, renal cell carcinoma, urothelial carcinoma, prostate cancer, head and neck squamous cell carcinoma, ovarian cancer, breast cancer, gastric/GEJ cancer, cervical, anal, or MSI-high\n2. Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)\n3. No prior grade 3 AEs on current standard of care cancer treatment regimen;\n4. Age ≥ 25 years; as by the age of 25 brain is fully developed.\n5. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM, by a board certified psychiatrist), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder; Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnosis are determined by a MD Anderson board certified psychiatrist.\n6. At least 6 months life expectancy as per primary medical oncologist.\n7. Have an ECOG performance status of 0, 1, or 2.\n8. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n9. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n10. Agree to abstain from any nicotine products for at least 12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed) as well as on days of salivary sample collection.\n11. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions (except as described above for nicotine and caffeine) and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Participant tested positive for a prescribed substance are eligible. Participant failing on the 2nd test (UDS) will be excluded.\n12. Must be free from any regularly scheduled psychotropic (antidepressant/anxiolytic class) medications and those with primary MOA on serotonergic neurons (e.g., ondansetron) for a minimum of 2 weeks prior to study or 4 weeks for SSRI. Intermittent or PRN use of short-acting anxiolytics may be permitted as defined below in exclusionary criteria).\n13. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n14. Eligible participants will have a responsible individual that will provide transportation home after the psilocybin session is complete.\n15. Fluent in English\n\nExclusion Criteria:\n\n1. History of depression prior to cancer diagnosis.\n2. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self-injurious behavior\n3. History of bipolar disorder, psychosis (of any nature), and seizures.\n4. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy.\n5. ECG with QTc \\> 450.\n6. Patients with metal implants.\n7. Asymptomatic ALT or AST elevations \\>/= 5X upper limit of normal, symptomatic ALT or AST elevations \\>/= 2X upper limit of normal, or total bilirubin \\>/= 2X upper limit of normal.\n8. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n   Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n   History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n9. persons with first- or second-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder.\n10. Actively progressing disease as defined by the primary oncologist.\n11. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n12. Participants with brain metastases.\n13. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (prior to dosing) Blood Pressure \\>140/90 mmHg and HR\\> 90 bpm.\n14. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n15. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm ii. Epilepsy iii. History of stroke iv. Cerebral aneurysm v. Dementia vi. Delirium\n16. a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>25 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. Niacin. Note: If taking any supplement containing niacin, agrees to suspend use for at least five days prior to dosing and for the duration of the study f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n    i. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\n    ii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\n    iii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    iv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use two weeks prior to baseline visit, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\n    g. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin h. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\n    i. Have an allergy or intolerance to any of the materials contained in either drug product j. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions)\n17. Participants who have any of the below niacin contraindications:\n\n    1. Active liver disease or unexplained persistent elevations in hepatic transaminases\n    2. active peptic ulcer disease\n    3. arterial bleeding\n    4. Hypersensitivity to niacin or any component of this medication\n18. BP\\> 200/110 (or malignant hypertension defined as 200/120) would prevent a patient from receiving psilocybin dosing and would prompt calling a physician during blood pressure monitoring for cardiac risk evaluation.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Moran Amit, MD","phone":"(713) 794-5304","email":"mamit@mdanderson.org"}],"primaryOutcomes":["Safety and adverse events (AEs)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Psilocybin for Depression, Anxiety","inPlainEnglish":"To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.","whoItsFor":["Ages 25 Years to any","Documentation of locally advanced, recurrent, or metastatic incurable malignancy that has partially responded or progressed after at least 1 available standard therapy and disease is stable (no progression of disease for 3 months or more on current treatment regimen)","No prior grade 3 AEs on current standard of care cancer treatment regimen;","Age ≥ 25 years; as by the age of 25 brain is fully developed","At least 6 months life expectancy as per primary medical oncologist","Have an how well you can do daily activities (ECOG score) of 0, 1, or 2","Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam)","Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments"],"whoShouldSkip":["History of depression prior to cancer diagnosis","Clinically significant suicidality or high risk of completed suicide defined as:","History of bipolar disorder, psychosis (of any nature), and seizures","Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total .glossectomy","ECG with QTc \\> 450","Patients with metal implants","Asymptomatic ALT or AST elevations \\>/= 5X upper limit of normal, symptomatic ALT or AST elevations \\>/= 2X upper limit of normal, or total bilirubin \\>/= 2X upper limit of normal"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, or Niacin. The registry lists allocation as randomized. To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 48 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.093Z"},{"nctId":"NCT06203600","title":"Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial","officialTitle":"Randomized Phase II/III Trial of 2nd Line Nivolumab + Paclitaxel + Ramucirumab Versus Paclitaxel + Ramucirumab in Patients With PD-L1 CPS &gt;/= 1 Advanced Gastric and Esophageal Adenocarcinoma (PARAMUNE)","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Adding nivolumab to ramucirumab and paclitaxel may work better to treat patients with advanced stomach or esophageal cancer.","conditions":["Advanced Esophageal Adenocarcinoma","Advanced Gastric Adenocarcinoma","Advanced Gastroesophageal Junction Adenocarcinoma","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Esophageal Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Metastatic Esophageal Adenocarcinoma","Metastatic Gastric Adenocarcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Unresectable Esophageal Adenocarcinoma","Unresectable Gastric Adenocarcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"DRUG","name":"Paclitaxel"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"BIOLOGICAL","name":"Ramucirumab"}],"enrollment":224,"startDate":"2024-06-24","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma\n* Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen\n* Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma\n* Participants must have documented unresectable and/or metastatic disease on CT or MRI imaging completed prior to registration. Imaging must have been completed within 28 days prior to registration for participants with measurable disease. CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form\n* Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration\n* Participants must have disease progression or intolerance to frontline standard of care (SOC) chemotherapy plus either nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor. Peri-operative chemotherapy plus nivolumab, pembrolizumab or any other PD-1 or PD-L1 inhibitor will count as one line if disease progression occurs while on the therapy or within 6 months of completing the chemotherapy plus nivolumab or pembrolizumab or other PD-1/PD-L1 inhibitor cycle\n* Participants must not have received more than one prior line of systemic therapy defined as chemotherapy plus either nivolumab, pembrolizumab, or any other PD-1 or PD-L1 inhibitor, in the stage IV or unresectable setting. Peri-operative or adjuvant nivoluamb or other PD-1/PD-L1 inhibitors would count as one prior line of systemic therapy if patients progressed while on nivolumab (or other PD-1/PD-L1 inhibitors) or within 6 months of stopping it\n\n  * Note: Radiation or any other regional therapy options done to address local residual disease or metastatic disease would not count as a line of therapy. Maintenance therapy with a different form of fluoropyrimidine (i.e. switching from capecitabine to fluorouracil \\[5FU\\]) would not count as another line of therapy\n* Participants must not have a condition requiring systemic treatment with either corticosteroids (\\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration. Inhaled or topical steroids and adrenal replacement doses \\< 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Participants are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted, even if \\< 10 mg/day prednisone equivalents. A brief course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as long as there has been a washout period for corticosteroids of ≥ 7 days prior to registration\n* Participants must not have prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agent including events like pneumonitis, myocarditis, renal failure, Guillain barre syndrome, or myasthenia gravis. Participants with endocrinopathy events leading or not to replacement steroids, thyroid hormone, insulin, or cortisol are eligible\n* Participants must not have received a live attenuated vaccination within 28 days prior to registration\n* Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded\n* Participants must not have plans to undergo elective or planned major surgery during the clinical trial\n* Participants must not have active bleeding or prior history of gastrointestinal (GI) perforation, fistula or significant GI bleeding (requiring transfusion, endoscopic or surgical intervention) within 84 days prior to registration\n* Participants must not be planning to receive any concurrent chemotherapy, immunotherapy, investigational agents, biologic or hormonal therapy for cancer treatment while receiving treatment on this study\n* Participants must not have a history of a grade 3 or 4 allergic reaction attributed to humanized or human monoclonal antibody therapy\n* Participants must not have a history of grade 3 or 4 immunotherapy related toxicities with the exception of hormonal abnormalities like thyroiditis or thyroid derangements\n* Participants must be ≥ 18 years old\n* Participants must have Zubrod Performance Status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 2 x 10\\^3/uL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.2 x 10\\^3/uL (within 28 days prior to registration)\n* Hemoglobin ≥ 9.0 g/dL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3/uL (within 28 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 28 days prior to registration) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration) (unless liver metastases are present, in which case they must be ≤ 5 x ULN)\n* Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants' urinary protein must be ≤ 1+ on dipstick or routine urinalysis (UA) within 28 days of registration. Random analysis of urine protein with a normal value is sufficient. If urine dipstick or routine analysis indicated proteinuria ≥ 2+, then a 24-hour urine is to be collected and demonstrate \\< 1000 mg of protein in 24 hours to allow participation in the study\n* Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* Participants must have recovered to baseline or \\< grade 2 CTCAE version (v) 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically stable on supportive therapy\n* Participants must not have experienced arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, within 6 months prior to registration\n* Participants must not have uncontrolled blood pressure within 28 days prior to registration as determined by the treating investigator\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants must not have a history of inflammatory bowel disease, (including ulcerative colitis and Crohn's disease), symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \\[scleroderma\\], systemic lupus erythematosus, autoimmune vasculitis \\[e.g., Wegener's Granulomatosis\\]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and myasthenia gravis, multiple sclerosis). Note: Participants with Graves' disease will be allowed\n* Participants must not have a history of pneumonitis that has required oral or IV steroids within the last 12 months prior to registration\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants who can complete patient reported outcomes (FACT-Ga and PRO-CTCAE) questionnaires in English or Spanish must participate in the quality of life studies\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","locations":[{"facility":"Baptist Health Medical Center - Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Anaheim","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Baldwin Park","city":"Baldwin Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Bellflower","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fontana","city":"Fontana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fresno","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente South Bay","city":"Harbor City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medicine of USC Koreatown","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United 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A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens).","whoItsFor":["Ages 18 Years to any","Participants must have advanced or locally unresectable gastric, gastroesophageal junction or esophageal adenocarcinoma","Participants must have PD-L1 CPS (Combined Positive Score) ≥ 1. This test would have been performed as part of standard of care (SOC) pathology testing, using tissue obtained within two years prior to registration and collected prior to or after a frontline regimen","Participants must have a histologically confirmed diagnosis of microsatellite stable (MSS) and HER2 negative gastric, gastroesophageal junction, or esophageal adenocarcinoma","Participants with treated brain metastases must have no evidence of progression on the follow-up brain imaging after central nervous system (CNS)-directed therapy. All treatment for brain metastases must have been completed at least 28 days prior to registration","Participants must not have received a live attenuated vaccination within 28 days prior to registration","Participants must not have had a major surgery within 28 days or subcutaneous venous access device placement within 7 days prior registration","Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator. Any participants with postoperative bleeding complications or wound complications from a surgical procedure performed in the last eight weeks should be excluded"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Magnetic Resonance Imaging. The registry lists allocation as randomized. This phase II/III trial compares the addition of nivolumab to the usual treatment of paclitaxel and ramucirumab to paclitaxel and ramucirumab alone in treating patients with gastric or esophageal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 224 people at 378 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.015Z"},{"nctId":"NCT06210711","title":"Trauma BPE Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","officialTitle":"Prevention of Posttraumatic Stress: A Randomized Controlled Trial of Brief Prolonged Exposure Therapy for Injured Individuals Admitted to a Level I Trauma Center","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Baylor Research Institute","sponsorClass":"OTHER","summary":"The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.","conditions":["Traumatic Injury","PTSD","Posttraumatic Stress Disorder"],"keywords":["PTSD","Traumatic injury","Posttraumatic stress disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Treatment as Usual"},{"type":"BEHAVIORAL","name":"Brief Prolonged Exposure Therapy"}],"enrollment":300,"startDate":"2024-02-28","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Between the ages of 18 and 75 years old.\n* Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \\& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH/MCW) Level 1 Trauma Center\n\nExclusion Criteria:\n\n* Patients in police custody\n* Patients not fluent in English\n* Patients with severe cognitive impairment\n* Patients who are acutely suicidal\n* Patients with active psychosis","locations":[{"facility":"Baylor University Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Scott & White Medical Center - Temple","city":"Temple","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert & Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alexis Evans, M.S","phone":"(214) 820-9918","email":"Alexis.Evans@BSWHealth.org"},{"name":"Kamiah Moss, PhD","phone":"","email":"Kamiah.Moss@BSWHealth.org"}],"primaryOutcomes":["Clinician Administered PTSD Scale for DSM-5 (CAPS-5)","PTSD Checklist for DSM-5 (PCL-5)"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["dallas-texas","temple-texas","milwaukee-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Treatment as Usual for Traumatic Injury","inPlainEnglish":"The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.","whoItsFor":["Ages 18 Years to 75 Years","Between the ages of 18 and 75 years old","Admitted to Baylor University Medical Center at Dallas (BUMC), Baylor Scott \\& White Medical Center at Temple (BSWMC), or Froedtert Hospital and the Medical College of Wisconsin (FH/MCW) Level 1 Trauma Center"],"whoShouldSkip":["Patients in police custody","Patients not fluent in English","Patients with severe cognitive impairment","Patients who are acutely suicidal","Patients with active psychosis"],"whatHappens":"If you join, the listed intervention(s) are Treatment as Usual, or Brief Prolonged Exposure Therapy. The registry lists allocation as randomized. The purpose of this research is to determine if a brief treatment method is effective for preventing posttraumatic stress disorder (PTSD) and a number of other concerns following injury.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.418Z"},{"nctId":"NCT06215105","title":"Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices","officialTitle":"Complex Aneurysm Registry - Real-World Evidence Data Collection for Intracranial Aneurysm Treatment Devices","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Microvention-Terumo, Inc.","sponsorClass":"INDUSTRY","summary":"To collect real-world evidence allowing assessment of functional, imaging, and safety outcomes of commercially available MicroVention devices used for the endovascular treatment of intracranial aneurysms (IA) at the direction of the treating physician.","conditions":["Cerebral Aneurysm","Intracranial Aneurysms"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Commercially available MicroVention Intracranial Aneurysm Treatment Devices"}],"enrollment":750,"startDate":"2024-02-19","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Patient must have a single ruptured or unruptured IA for which endovascular treatment has been determined appropriate.\n2. Patient will be treated using a commercially available MicroVention implant device as the primary treatment device and the decision to use this device has been made by the treating physician outside the context of the CAR study and prior to enrollment. Note: For the purposes of this protocol, ancillary/accessory devices such as balloon catheters and other access devices are not considered primary treatment devices.\n3. Patient or patient 's legally authorized representative (LAR) has provided written informed consent prior to treatment and no later than 48 hours post procedure for emergent treatment of ruptured aneurysms.\n4. Patient must be considered by the treating physician to be available for and able to complete study follow-up visits.\n\nExclusion Criteria\n\n1. Target aneurysm has been previously treated via surgical or endovascular means.\n2. Patient is enrolled in another device or drug study in which participation could confound study results.\n3. Patient has a life expectancy of less than 1 year due to other illness or condition (in addition to an intracranial aneurysm).\n4. Patient has been previously enrolled into this study.","locations":[{"facility":"Walnut Creek Medical Center","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hartford Hospital","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broward Health Medical Center","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Regional Hospital","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Medical Center, Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center - 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The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 750 people at 27 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.059Z"},{"nctId":"NCT06215716","title":"A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Akero Therapeutics, Inc","sponsorClass":"INDUSTRY","summary":"This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).\n\nThe study will enroll subjects in two cohorts for a total samples size of 1650 subjects.","conditions":["NASH With Fibrosis","MASH With Fibrosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Efruxifermin"},{"type":"DRUG","name":"Placebo"}],"enrollment":1650,"startDate":"2023-12-01","completionDate":"2033-02","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit.\n* Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes.\n* Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:\n\n  * Steatosis (scored 0 to 3),\n  * Ballooning degeneration (scored 0 to 2), and\n  * Lobular inflammation (scored 0 to 3).\n* Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. 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The study will enroll subjects in two cohorts for a total samples size of 1650 subjects.","whoItsFor":["Ages 18 Years to 80 Years","Males and non-pregnant, non-lactating females between 18 - 80 years of age inclusive, based on the date of the screening visit","Previous history or presence of 2 out of 4 components of metabolic syndrome (obesity, dyslipidemia, elevated blood pressure, elevated fasting glucose) or type 2 diabetes","Cohort 1: Biopsy-proven NASH/MASH. Must have had a liver biopsy obtained ≤ 180 days prior to screening with fibrosis stage 2 or 3 and a non-alcoholic fatty liver disease (NAFLD) activity score (NAS) of ≥ 4 with at least a score of 1 in each of the following NAS components:","Steatosis (scored 0 to 3),","Ballooning degeneration (scored 0 to 2), and","Lobular inflammation (scored 0 to 3)","Cohort 2: Biopsy-proven fibrosis stage 3. Must have had a liver biopsy obtained ≤ 180 days prior to screening. Subjects with NAS \\<4 may be enrolled and are not required to meet 1 point in each of the components of NAS"],"whoShouldSkip":["Other causes of liver disease based on medical history and/or liver histology and/or central laboratory results","Presence of cirrhosis on liver biopsy (fibrosis stage 4)","Type 1 or uncontrolled Type 2 diabetes","Other inclusion and"],"whatHappens":"If you join, the listed intervention(s) are Efruxifermin, or Placebo. The registry lists allocation as randomized. This is a multi-center evaluation of efruxifermin (EFX) in a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,650 people at 293 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.146Z"},{"nctId":"NCT06216301","title":"LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC","officialTitle":"LUNAR-2: Pivotal, Randomized, Open-Label Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab and Platinum-based Chemotherapy for the Treatment of Metastatic Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NovoCure GmbH","sponsorClass":"INDUSTRY","summary":"This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body. The primary goals of the study are to assess overall survival and progression-free survival. Secondary objectives include analyzing outcomes based on the specific histology (subtype) of the lung cancer.","conditions":["Metastatic Non-small Cell Lung Cancer"],"keywords":["NSCLC","Metastatic"],"interventions":[{"type":"DEVICE","name":"NovoTTF-200T"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Platinum based chemotherapy"}],"enrollment":734,"startDate":"2024-07-31","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* ≥22 years of age in the USA\n\n  ≥18 years of age outside of the USA.\n* Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \\[AJCC\\] criteria) non-squamous or squamous NSCLC.\n* Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1.\n* Have not received prior systemic treatment for their metastatic NSCLC. Subjects who received adjuvant, neoadjuvant chemotherapy or chemoradiotherapy with curative intent for non-metastatic disease are eligible if the therapy was completed at least 12 months prior to the development of metastatic disease.\n* ECOG Performance Status (PS) of 0-1.\n* Adequate hematologic and end-organ function\n\n  o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants).\n* A female participant is eligible to participate if she is not pregnant, not breastfeeding\n* If male subject with a female partner(s) of child-bearing potential, must agree to use an effective contraception\n* All subjects must sign written informed consent.\n\nExclusion Criteria:\n\nAll individuals meeting any of the following exclusion criteria will be excluded from study participation:\n\n* Mixed small cell and NSCLC histology.\n* EGFR sensitizing mutation and/or ALK translocation, and/or ROS1 and/or RET targetable gene rearrangement, and/or METex14 skipping mutation, and/or NTRK1/2 gene fusion and/or BRAF V600 mutations directed therapy is indicated or planned for other targeted therapy, where such testing and therapy is locally approved and available.\n* Has received systemic therapy for metastatic disease.\n* Had major surgery \\<3 weeks prior to randomization\n* Received radiation therapy to the lung that is \\> 30 Gy within 6 months of randomization.\n* Has received prior radiotherapy within 2 weeks of randomization. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Is expected to require any other form of antineoplastic therapy while on study.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  * Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded\n* Has symptomatic Central Nervous System (CNS) metastases and/or carcinomatous meningitis. Subjects with asymptomatic CNS metastases or with previously treated brain metastases may participate provided they were treated before randomization (if applicable) and are neurologically stable and without requirement of steroid treatment for at least 7 days prior to randomization.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior randomization. Subjects with asthma that require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.\n* Had prior treatment with any other anti-PD-1, or PD-L1 or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms in the 12 months prior to randomization.\n* Participation in another clinical study with an investigational agent or device during the 4 weeks prior to randomization.\n* Concurrent treatment with other experimental treatments for NSCLC while in the study.\n* Has a known sensitivity to any component of the planned systemic therapies (pembrolizumab, cisplatin/carboplatin, pemetrexed/paclitaxel/nab-paclitaxel) .\n* Pregnant or breastfeeding\n* Admitted to an institution by administrative or court order.","locations":[{"facility":"Central Alabama Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western Regional Medical Center, LLC","city":"Goodyear","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Herritage Medical Group","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Family Cancer Institute - 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The primary goals of the study are to assess overall survival and progression-free survival.","whoItsFor":["Ages 18 Years to any","≥22 years of age in the USA","≥18 years of age outside of the USA","Histologically or cytologically diagnosis of stage 4 (according to Version 8 of the American Joint Committee on Cancer \\[AJCC\\] criteria) non-squamous or squamous NSCLC","Evaluable (measurable or non-measurable) disease in the thorax per RECIST v1.1","how well you can do daily activities (ECOG score) (PS) of 0-1","Adequate hematologic and end-organ function","o For subjects not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 x ULN (unless participant is receiving anticoagulant therapy as long as INR or aPTT is within therapeutic range of intended use of anticoagulants)"],"whoShouldSkip":["All individuals meeting any of the following"],"whatHappens":"If you join, the listed intervention(s) are NovoTTF-200T, Pembrolizumab, or Platinum based chemotherapy. The registry lists allocation as randomized. This study, known as LUNAR-2, aims to investigate the effectiveness and safety of using TTFields, delivered by the NovoTTF-200T device, concomitantly administered with pembrolizumab and platinum-based chemotherapy for patients with advanced non-small cell lung cancer that has spread to other parts of the body.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 734 people at 107 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.715Z"},{"nctId":"NCT06217120","title":"Reversing Microvascular Dysfunction in Heart Failure With Preserved Ejection Fraction","officialTitle":"Reversing Microvascular Dysfunction in Heart Failure With Ejection Fraction > 40% Using Colchicine (The COL-Micro-HF Study)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Montreal Heart Institute","sponsorClass":"OTHER","summary":"This study will evaluate the impact of colchicine on the change in myocardial flow reserve (MFR), a marker for coronary microvascular dysfunction (CMD), compared to a matched placebo in patients with heart failure and ejection fraction above 40% (including patients with improved EF).","conditions":["Heart Failure With Preserved Ejection Fraction","Microvascular Coronary Artery Disease"],"keywords":["Heart Failure with Preserved Ejection Fraction","Microvascular Coronary Artery Disease","Inflammation","Colchicine"],"interventions":[{"type":"DRUG","name":"Colchicine"},{"type":"DRUG","name":"Placebo"}],"enrollment":64,"startDate":"2026-11-06","completionDate":"2027-04","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subjects ≥ 40 years of age,\n2. Chronic symptomatic HF and left ventricular ejection fraction (LVEF) \\> 40% within 12 months prior to screening visit (regardless of the imaging modality) and one of the following abnormalities:\n\n2a. HF requiring hospitalization and IV diuretics within 12 months of study entry, or 2b. NTproBNP \\> 150pg/ml in sinus rhythm or NTproBNP \\> 450pg/ml in chronic atrial fibrillation, 3. The presence of coronary microvascular dysfunction (CMD) at baseline assessed using dipyridamole-based PET imaging and defined as myocardial functional reserve (MFR) \\< 2.0, 4. Symptoms of HF requiring current treatment with loop diuretics for ≥ 30 days, 5. NYHA functional class II to (ambulatory) IV, 6. High-sensitivity C-reactive protein (hs-CRP) \\> 5mg/L at baseline, 7. Subjects with the capacity to provide informed consent.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of infiltrative cardiomyopathy,\n2. Presence of primary severe valvular heart disease (functional MR/TR are not excluded),\n3. Presence of active infection within the 3 months prior to enrollment needing antibiotics,\n4. Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent PCI within the 3 months prior to enrollment,\n5. Known or clinically judged significant (i.e., angina with CCS class \\> 2/4) epicardial coronary artery disease (CAD) that has not been revascularized (revascularized CAD is defined by a history of myocardial infarction, percutaneous intervention, or coronary artery bypass grafting),\n6. History of hypersensitivity to colchicine,\n7. Evidence of hepatic disease as determined by any 1 of the following: SGOT (AST) or SGPT (ALT) values exceeding 3× the upper limit of normal at enrollment; or patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease,\n8. Patients with at most moderate renal impairment defined as an eGFR \\< 59 ml/min/1.73 m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at enrollment,\n9. Subject with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or patient with chronic diarrhea,\n10. Patient with pre-existent progressive neuromuscular disease,\n11. Patient currently taking colchicine for other indications (Familial Mediterranean Fever, gout or post MI). There is no wash-out period required for patients who have been treated with colchicine and stopped treatment prior to enrolment,\n12. Patients under long-term systemic steroid medication or any chronic use of anti- inflammatory medication (including Non-steroidal Anti-inflammatory Drugs, NSAIDS),\n13. Contra-indications to dipyridamole use (PET-imaging): Patients with bronchospastic lung disease with ongoing wheezing; Acute myocardial infarction or unstable angina in the past 48h; Uncontrolled hypertension (systolic pressure of over 200 mmHg or a diastolic pressure of over 110 mmHg); Symptomatic hypotension; Untreated second- or third-degree atrioventricular block; Known hypersensitivity to dipyridamole; Caffeine intake in the previous 12 hours\n14. Contra-indications to aminophylline use (PET-imaging): epilepsy, peptic ulcer (active) and hypersensitivity to aminophylline, theophylline, ethylenediamine, or any component of the formulation\n15. Positive pregnancy test result at the screening visit, and females of childbearing potential who do not agree to use adequate method of contraception for the duration of the study; acceptable means of birth control include: implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, intrauterine devices, male or female condoms with spermicide, abstinence, or a sterile sexual partner,\n16. History or presence of any other disease with a life expectancy of \\<1 year,\n17. Patient considered by the investigator, for any reason, to be an unsuitable candidate for the study,\n18. Drug-drug interaction (competitive inhibition of CYP3A4 and P-gp): Patients treated with amiodarone, dronedarone, quinidine, propafenone, diltiazem, azithromycin or high-intensity statin therapy.","locations":[{"facility":"Centre de recherche du Centre hospitalier de l'Université de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in myocardial flow reserve (MFR) between baseline and six months"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Phase 2: testing Colchicine for Heart Failure With Preserved Ejection Fraction","inPlainEnglish":"This study will measure the impact of colchicine on the change in myocardial flow reserve (MFR), a marker for coronary microvascular dysfunction (CMD), compared to a matched dummy treatment (placebo) in patients with heart failure and ejection fraction above 40% (including patients with improved EF).","whoItsFor":["Ages 40 Years to any","Subjects ≥ 40 years of age,","Chronic symptomatic HF and left ventricular ejection fraction (LVEF) \\> 40% within 12 months prior to screening visit (regardless of the imaging modality) and one of the following abnormalities:"],"whoShouldSkip":["Patients with a diagnosis of infiltrative cardiomyopathy,","Presence of primary severe valvular heart disease (functional MR/TR are not excluded),","Presence of active infection within the 3 months prior to enrollment needing antibiotics,","Acute decompensated HF, acute coronary syndrome (including MI), cardiac surgery, other major cardiovascular surgery, or urgent PCI within the 3 months prior to enrollment,","History of hypersensitivity to colchicine,","Evidence of hepatic disease as determined by any 1 of the following: SGOT (AST) or SGPT (ALT) values exceeding 3× the upper limit of normal at enrollment; or patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease,","Patients with at most moderate renal impairment defined as an eGFR \\< 59 ml/min/1.73 m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at enrollment,"],"whatHappens":"If you join, the listed intervention(s) are Colchicine, or Placebo. The registry lists allocation as randomized. This study will measure the impact of colchicine on the change in myocardial flow reserve (MFR), a marker for coronary microvascular dysfunction (CMD), compared to a matched dummy treatment (placebo) in patients with heart failure and ejection fraction above 40% (including patients with improved EF).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 64 people at Montreal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.423Z"},{"nctId":"NCT06219863","title":"Harness-based Mobility Intervention for Infants With Down Syndrome","officialTitle":"Feasibility and Outcome Measures for Infants With Down Syndrome: Advancing Clinical Trial Readiness for a Harness-based Mobility Intervention","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Boston University Charles River Campus","sponsorClass":"OTHER","summary":"The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction. This project will set the stage for the first clinical trial of a mobility-related intervention specifically tailored for infants with DS by testing the feasibility of harness systems with infants and families and identifying measures that will serve as primary outcome variables. Upon completion of this pilot project, necessary preliminary data and experience required for an in-home, high-impact clinical trial for infants with DS will have been obtained.","conditions":["Down Syndrome"],"keywords":["infant"],"interventions":[{"type":"BEHAVIORAL","name":"Body weight supported harness"}],"enrollment":6,"startDate":"2024-07-31","completionDate":"2027-12","sex":"ALL","minAge":null,"maxAge":"2 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* confirmed diagnosis of Trisomy 21\n* younger than 24 months\n* English is the primary language of the home (due to use of standardized language assessments normed on English-speaking children)\n* able to sit without support\n* not yet taking any independent steps.\n\nExclusion Criteria:\n\n* Mosaic or Translocation Down syndrome\n* severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)\n* severe uncorrected hearing or vision impairments","locations":[{"facility":"Boston University","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Donato","phone":"(774) 275-3321","email":"buicl.studies@gmail.com"}],"primaryOutcomes":["Mean posture duration in seconds","Mean number of locomotion bouts","Mean time spent in contact with objects","Mean number of different objects contacted","Mean number of vocalizations","Mean number of gestures","Proportion of directed vocalizations","Proportion of directed gestures","Bayley Scales of Infant Development-4","Early Social Communication Scales","MacArthur-Bates Communication Development Inventory: Words & Gestures"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Body weight supported harness for Down Syndrome","inPlainEnglish":"The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning. Increasing infant mobility early in development with body weight supported harness systems may support infant exploration, communication, and social interaction.","whoItsFor":["Ages any to 2 Years","confirmed diagnosis of Trisomy 21","younger than 24 months","English is the primary language of the home (due to use of standardized language assessments normed on English-speaking children)","able to sit without support","not yet taking any independent steps"],"whoShouldSkip":["Mosaic or Translocation Down syndrome","severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)","severe uncorrected hearing or vision impairments"],"whatHappens":"If you join, the listed intervention(s) are Body weight supported harness. The registry lists allocation as na. The emergence of crawling and walking is significantly delayed in infants with Down syndrome (DS), but the development of independent mobility provides infants with new opportunities for exploring the environment and interacting with objects and people that are important foundations for early learning.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 6 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.447Z"},{"nctId":"NCT06221358","title":"Pharmacogenomics of Stimulant Treatment Response","officialTitle":"Pharmacogenomics of Stimulant Treatment Response in Children and Adolescents With Attention-Deficit/ Hyperactivity Disorder","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Calgary","sponsorClass":"OTHER","summary":"The \"Pharmacogenomics of Stimulant Treatment Response\" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with Attention deficit/hyperactivity disorder (ADHD).","conditions":["Attention-Deficit/ Hyperactivity Disorder (ADHD)"],"keywords":["Children","Adolescents","ADHD","Pharmacogenetics","Neurology","Psychostimulants","Methylphenidate"],"interventions":[],"enrollment":400,"startDate":"2024-04-01","completionDate":"2028-08-31","sex":"ALL","minAge":"6 Years","maxAge":"24 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatients will be eligible for participation if all the following are true.\n\n* Aged 6 - 24 years.\n* Located in Canada.\n* Primary diagnosis of ADHD (all types).\n* Starting Methylphenidate (excluding immediate release forms) treatment.\n\nExclusion Criteria:\n\nPatients will be excluded from participation if any of the following are true.\n\n* Co-occurring psychotic, bipolar or eating disorders.\n* Significant risk of suicide.\n* An intellectual disability, or diagnosis of autism spectrum disorder (ASD) or tics/Tourette disorders.\n* Past 12-month high-risk alcohol or substance use defined as monthly or more frequent use.\n* Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study\n* History of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results.","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Weng-Sam Siu, MSPT, MSc","phone":"5875739747","email":"sam.siu@ucalgary.ca"},{"name":"Madison Heintz, MSW","phone":"5875739747","email":"psychpgxlab@ucalgary.ca"}],"primaryOutcomes":["Change in ADHD symptom severity","Side effect frequency and severity"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["calgary-canada"],"enrichment":{"headline":"Pharmacogenomics of Stimulant Treatment Response","inPlainEnglish":"The \"Pharmacogenomics of Stimulant Treatment Response\" (PGx-STaR) study aims to identify genetic profiles related to methylphenidate treatment outcomes in children and adolescents aged 6-24 with Attention deficit/hyperactivity disorder (ADHD).","whoItsFor":["Ages 6 Years to 24 Years","Patients will be eligible for participation if all the following are true","Primary diagnosis of ADHD (all types)","Starting Methylphenidate (excluding immediate release forms) treatment"],"whoShouldSkip":["Patients will be excluded from participation if any of the following are true","Co-occurring psychotic, bipolar or eating disorders","Significant risk of suicide","An intellectual disability, or diagnosis of autism spectrum disorder (ASD) or tics/Tourette disorders","Past 12-month high-risk alcohol or substance use defined as monthly or more frequent use","Psychotherapy or brain stimulation-based therapy initiated within 8 weeks of referral or plans to initiate/change these types of therapies during the study","History of liver or bone marrow (hematopoietic cell) transplant as these events can result in ambiguous genomic results"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Calgary. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.647Z"},{"nctId":"NCT06226610","title":"Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic","officialTitle":"A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy of Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Akron Children's Hospital","sponsorClass":"OTHER","summary":"The goal of this study is to test the efficacy of Dupixent in improving post-burn itching symptoms versus the current standard of care.","conditions":["Pruritis"],"keywords":["Itching, itch"],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"OTHER","name":"Placebo"}],"enrollment":46,"startDate":"2024-11-21","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n• Persons 18-60 year old with post-burn hypertrophic scars of any size which required grafting or epidermal autografting for an acute burn injury, with continued complaint of pruritus due to inadequate relief from standard of care (medical management by antihistamine and neuroleptic medications) after at least four weeks and are a minimum of four weeks after their last grafting surgery, and who speak English sufficient to participate in the study.\n\nExclusion Criteria:\n\n* Currently taking Dupixent for any other diagnosis\n* known allergy to Dupixent\n* pregnant and or lactating mothers\n* anyone treated for pruritus using laser therapy\n* currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications\n* Currently taking steroids\n* persons with developmental delays or otherwise unable to complete measures\n* prisoners or anyone otherwise unable to give their own consent or who is not their own guardian\n* one or more of the following existing disorders: conjunctivitis; any co-existing dermatological condition except burns; any type of cancer; requiring dialysis; chronic Stage 3 or higher kidney disease; biliary disorder; gall bladder disorder; or another renal or hepatic disorder which, in the opinion of study physician, deems this study inappropriate for an eligible individual.\n* Persons unable to provide their own consent, including prisoners when their incarcerated status is not itself the focus of study, are routinely excluded from clinical trials at this site\n* We further exclude persons with other dermatological conditions (other than burn) , which may have pruritis or pain associated with them and who may be treated with medications other than Dupixent, and whose perceived benefit could confound our results.\n* We similarly exclude anyone treated for pruritis by laser therapy as their perceived benefit could confound our results.","locations":[{"facility":"Akron Children's Hospital","city":"Akron","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ANJAY KHANDELWAL, MD","phone":"330-543-4649","email":"akhandelwal@akronchildrens.org"},{"name":"Jessica Kracker, BSN","phone":"330-543-0846","email":"jkracker@akronchildrens.org"}],"primaryOutcomes":["Itch Severity Scale (ISS) Scores"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["akron-ohio"],"enrichment":{"headline":"Phase 2: testing Dupilumab for Pruritis","inPlainEnglish":"The goal of this study is to test the how well it works of Dupixent in improving post-burn itching symptoms versus the current standard of care.","whoItsFor":["Ages 18 Years to 60 Years"],"whoShouldSkip":["Currently taking Dupixent for any other diagnosis","known allergy to Dupixent","pregnant and or lactating mothers","anyone treated for pruritus using laser therapy","currently receiving adequate relief for pruritis under standard of care medical management by antihistamine or neuroleptic medications","Currently taking steroids","persons with developmental delays or otherwise unable to complete measures"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. The goal of this study is to test the how well it works of Dupixent in improving post-burn itching symptoms versus the current standard of care.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 46 people at Akron. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.703Z"},{"nctId":"NCT06226883","title":"A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of 3 Active Dose Regimens of MORF-057 in Adults With Moderately to Severely Active Crohn's Disease (GARNET)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)","sponsorClass":"INDUSTRY","summary":"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).","conditions":["Inflammatory Bowel Diseases","Crohn's Disease"],"keywords":["Crohn's disease (CD)","Inflammatory bowel disease (IBD)","a4b7","Moderate-to-severe","Integrin","GARNET"],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"MORF-057"}],"enrollment":385,"startDate":"2024-07-18","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Has signs/symptoms of CD for at least 90 days prior to screening\n* Has a CDAI score of 220 to 450, with an average daily stool subscore ≥4 points and/or an average daily abdominal pain subscore of ≥2 points\n* Has an SES-CD score of ≥6 (or an SES-CD score of ≥4 if CD is isolated to the ileum)\n* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following treatments: Corticosteroids, Immunosuppressants (eg, azathioprine, 6-mercaptopurine, methotrexate) and/or advanced therapies for CD (eg, biologic agents, Janus kinase \\[JAK\\] inhibitors, applicable investigational products)\n\nKey Exclusion Criteria:\n\n* Diagnosed with indeterminate colitis, microscopic colitis, ischemic colitis, radiation colitis, or UC, or has clinical findings suggestive of UC\n* Has CD that is isolated to the oral cavity, stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Has had extensive bowel resection (\\>100 cm), and/or more than 3 resections, and/or has a known diagnosis of short bowel syndrome\n* Is currently receiving total parenteral nutrition, tube feeding, or a formula diet\n* Has positive findings on a subjective neurological screening questionnaire\n* Has a concurrent, clinically significant, serious, unstable comorbidity\n* Previous treatment with vedolizumab or other licensed or investigational integrin inhibitors\n* Is currently participating in any other interventional study or has received any investigational therapy within 30 days\n* Previous exposure to MORF-057 and/or a known hypersensitivity to drugs with a similar mechanism to MORF-057\n* Unable to attend study visits or comply with study procedures\n* Has a history of any major neurological disorders, including: stroke, multiple sclerosis, brain tumor, demyelinating, or neurodegenerative disease","locations":[{"facility":"Gastro Care Institute","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Infinity Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peak Gastroenterology Associates - Colorado Springs","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Osceola","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partner-Kendale Lakes","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endoscopic Research Inc","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tropical Clinical Trials","city":"Palmetto Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Gastroenterology Specialists, PC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Gastroenterology Associates (Part of United Digestive)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Houma","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SSM Health DePaul Hospital- St. Louis","city":"Bridgeton","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Las Vegas Clinical Trials","city":"North Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cross Creek Medical Clinic","city":"Fayetteville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peters Medical Research","city":"High Point","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Research Associates","city":"Raleigh","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Palmetto Gastroenterology Clinical Research","city":"Summerville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastrointestinal Associates of Northeast Tennessee","city":"Johnson City","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - 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The registry lists allocation as randomized. This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study to measure the how well it works and safety of 3 active dose regimens of MORF-057 in adult study participants with moderately to severely active Crohn's disease (CD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 385 people at 224 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.891Z"},{"nctId":"NCT06227377","title":"QTX3034 in Patients With KRAS G12D Mutation","officialTitle":"A Phase 1 Trial Evaluating the Safety, Tolerability, PK, and Efficacy of QTX3034 in Patients With Solid Tumors With KRASG12D Mutation","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Quanta Therapeutics","sponsorClass":"INDUSTRY","summary":"Phase 1 study to determine the safety and tolerability of QTX3034 as a single agent or in combination with cetuximab.","conditions":["Solid Tumors"],"keywords":[],"interventions":[{"type":"DRUG","name":"QTX3034"},{"type":"COMBINATION_PRODUCT","name":"Cetuximab"}],"enrollment":250,"startDate":"2024-02-05","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically documented, locally advanced or metastatic malignancy with KRAS G12D mutation identified through molecular testing (NGS- or PCR-based) with a Clinical Laboratory Improvement Amendments-certified (or equivalent) diagnostic\n* Part 1: - 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The registry lists allocation as randomized. Phase 1 study to determine the whether it is safe and how hard side effects are to live with of QTX3034 as a single agent or in combination with cetuximab.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 250 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.628Z"},{"nctId":"NCT06229210","title":"Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder","officialTitle":"An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia, Bipolar Disorder, or Autism Spectrum Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, global, 26-week, open-label study to assess the safety and tolerability of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.","conditions":["Schizophrenia","Bipolar Disorder","Autism Spectrum Disorder"],"keywords":["Pediatric"],"interventions":[{"type":"DRUG","name":"Lumateperone"}],"enrollment":300,"startDate":"2024-01-25","completionDate":"2032-04-28","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to provide consent as follows:\n\n  * The patient's legally authorized representative (LAR) (eg, parent or guardian) must provide written, informed consent;\n  * The patient must provide written assent to study enrollment;\n* Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of schizophrenia, bipolar I or II disorder, or autism spectrum disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study.\n\nRollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator.\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:\n\n  * ADHD: If a subject is taking psychostimulant(s) for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to Screening. The treatment regimen should remain stable throughout the study. This must be confirmed by the Investigator and noted in the source records.\n  * For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary.\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n  * At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or\n  * The patient is considered to be an imminent danger to him/herself or others.","locations":[{"facility":"Southwest Autism Research and Resource Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research, LLC","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center, Inc","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute Of Clinical Research","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research Inc","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group Inc","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of California - Davis","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of California San Diego","city":"San Diego","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Next Level Clinical Trials, LLC","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCB Clinical Research Centers LLC","city":"Colorado Springs","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Royal Palm Clinical Research","city":"Fort Myers","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Sarkis Clinical Trials","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"United Research Institute","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute of Miami","city":"Homestead","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Green Leaf Clinical Trials","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vital Care Research","city":"Miami","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Columbus Clinical Services LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Research Center Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blue Medical Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP Medical Research","city":"Miami","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Envision Trials LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GTL Medical and Research Group","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Diverse Clinical Research LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Links Clinical Trials","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Med Research Inc","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angel Medical Research Corporation","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riveldi Biomedical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"APG Research LLC","city":"Orlando","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Clinical Research Center of Florida","city":"Pompano Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida Rothman Center of Neuropsychiatry","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Synergy Clinical Research","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExeli Research LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Behavioral Research, LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Salveo Integrative Health Inc","city":"Lawrenceville","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"CenExeli Research LLC 1","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baber Research Group","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children at Indiana University Health","city":"Indianapolis","state":"Indiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Neurobehavioral Medicine Group","city":"Bloomfield Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Research Group 1","city":"Saint Charles","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alivation Research LLC","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Southern Nevada, LLC","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Child Study Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond Behavioral Associates","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quest Therapeutics of Avon Lake","city":"Avon Lake","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charak Center for Health and Wellness","city":"Garfield Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sooner Clinical Research","city":"Norman","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cutting Edge Research Group","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Access Clinical Trials","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Research Group","city":"Coppell","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PsyMed Solutions","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaleidoscope Clinical Research","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red Oak Psychiatry Associates","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIM Trials","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perceptive Pharma Research","city":"Richmond","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Core Clinical Research","city":"Everett","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones y Proyectos en Neurociencias CIPNA","city":"Barranquilla","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOMO - ESE Hospital Mental de Antioquia","city":"Bello","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinic of Neurology and Psychiatry for Children and Youth","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mental Health Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center NIS","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Center of Vojvodina","city":"Novi Sad","state":"","country":"Serbia","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Incidence of Common Adverse Events"],"hasResults":false,"conditionSlugs":["bipolar-disorder","schizophrenia"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","little-rock-arkansas","anaheim-california","garden-grove-california","oceanside-california","redlands-california","sacramento-california","san-diego-california","west-covina-california","colorado-springs-colorado","fort-myers-florida","gainesville-florida","hialeah-florida","homestead-florida","jacksonville-florida","miami-florida","miami-gardens-florida","miami-lakes-florida","orlando-florida","pompano-beach-florida","st-petersburg-florida","west-palm-beach-florida","atlanta-georgia","lawrenceville-georgia","savannah-georgia","naperville-illinois","indianapolis-indiana","bloomfield-hills-michigan","saint-charles-missouri","lincoln-nebraska","las-vegas-nevada","new-york-new-york","staten-island-new-york","avon-lake-ohio","cincinnati-ohio","garfield-heights-ohio","norman-oklahoma","oklahoma-city-oklahoma","nashville-tennessee","coppell-texas","fort-worth-texas","houston-texas","plano-texas","richmond-texas","richmond-virginia","bellevue-washington","everett-washington","barranquilla-colombia","bello-colombia","belgrade-serbia","ni-serbia","novi-sad-serbia"],"enrichment":{"headline":"Phase 3: testing Lumateperone for Schizophrenia","inPlainEnglish":"This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.","whoItsFor":["Ages 5 Years to 17 Years","The patient must provide written assent to study enrollment;","Male or female patients aged 13 to 17 years (inclusive) with schizophrenia; male or female patients aged 10 to 17 years (inclusive) with bipolar I or II disorder; or male or female patients aged 5 to 17 years (inclusive) with autism spectrum disorder;","Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the study","Rollover Patients entering from the lead-in study must have safely completed the lead-in study, in the opinion of the Investigator"],"whoShouldSkip":["Has a primary psychiatric diagnosis other than schizophrenia, bipolar I or bipolar II disorder or autism spectrum disorder. Schizophrenia with catatonia, or bipolar disorder with psychotic features are not allowed. Exceptions include:","For ASD patients only, based on Investigator opinion and DSM-5 criteria, mild or moderate intellectual disability is allowed. Severe or profound intellectual disability is exclusionary","In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during their participation in the study or","At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;","At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or","At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) of the CDRS-R (for bipolar disorder patients only); or","The patient is considered to be an imminent danger to him/herself or others"],"whatHappens":"If you join, the listed intervention(s) are Lumateperone. The registry lists allocation as na. This is a multicenter, global, 26-week, open-label study to assess the whether it is safe and how hard side effects are to live with of lumateperone in pediatric patients with schizophrenia, bipolar disorder or autism spectrum disorder.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.730Z"},{"nctId":"NCT06232668","title":"Molecular Study of the Maternal-fetal Interface in Preeclampsia.","officialTitle":"Molecular Study of the Maternal-fetal Interface Prospectively to the Onset of Preeclampsia Using Single Cell Technology.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Carlos Simon Foundation","sponsorClass":"OTHER","summary":"Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed. Thus, the detection of women at risk of suffering PE is key to apply preventive and treatment strategies. Recently, the maternal contribution to PE based on defective decidualization that prevents the establishment of a functional maternal-fetal interface has been evidenced. The main objective of this study is to identify molecular markers or aberrant maternal-fetal cell types that can be detected early in the development of the disease in maternal-fetal interface tissue (chorionic villi + decidua) collected during gestational weeks 9 to 15. Maternal-fetal interface biopsy will be collected from women who have a recommendation for aneuploidy testing. The remaining fragment will be used for this study.","conditions":["Preeclampsia"],"keywords":["Preeclampsia","Early onset Preeclampsia (EOPE)","First trimester","Chorionic villi","Pregnancy","Molecular study","Decidua","Maternal-fetal interface","Other pregnancy complications","Omic techniques"],"interventions":[{"type":"PROCEDURE","name":"Maternal-fetal interface biopsy and peripheral blood collection in cases group"},{"type":"PROCEDURE","name":"Maternal-fetal interface biopsy and peripheral blood collection in control group"},{"type":"PROCEDURE","name":"Maternal-fetal interface biopsy and peripheral blood collection in cases group"},{"type":"PROCEDURE","name":"Maternal-fetal interface biopsy and peripheral blood collection in control group"}],"enrollment":2084,"startDate":"2023-11-20","completionDate":"2027-12","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients whose written informed consent approved by the Ethics Committee (EC) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.\n* Women over the age of 18 at the time of signing the informed consent form.\n* Women who meet at least one of the following criteria at the time of inclusion:\n\nPhase 1 (first trimester): Pregnant women between 9 and 15 weeks of gestation who are scheduled to undergo chorionic villus sampling (CVS) as part of the center's routine clinical practice.\n\nPhase 2 (delivery): Women with an ongoing pregnancy, regardless of gestational age and without the requirement of having participated in Phase 1, who are willing to donate placental and maternal blood samples following delivery.\n\nExclusion Criteria:\n\n* Women with multiple pregnancy.\n* Non-evolving pregnancies (including delayed abortion/foetal orbit).","locations":[{"facility":"Hospital General Universitario Dr. Balmis","city":"Alicante","state":"Alicante","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario Virgen de la Arrixaca","city":"Murcia","state":"Murcia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Canarias","city":"Santa Cruz de Tenerife","state":"Santa Cruz de Tenerife","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario y Politécnico La Fe","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Érika Ortiz, BSc, MSc","phone":"+34962938210","email":"clinicalstudies@fundacioncarlossimon.com"},{"name":"Carlos Simón, MD, PhD","phone":"","email":""}],"primaryOutcomes":["To charactize the molecular profile of the maternal-fetal interface (chorionic billi and decidua) between 9 and 15 weeks of gestation in healthy and preeclamptic pregnancies"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["alicante-spain","murcia-spain","santa-cruz-de-tenerife-spain","valencia-spain"],"enrichment":{"headline":"Not a traditional drug phase: Maternal-fetal interface biopsy and peripheral blood collection in cases group for Preeclampsia","inPlainEnglish":"Preeclampsia (PE) is a major obstetric complication with short- and long-term consequences for the mother and the fetus. Early screening tools to reduce its mortality and morbidity, as well as to prevent the life-threatening consequences are needed.","whoItsFor":["Ages 18 Years to any","Women only","Women who meet at least one of the following criteria at the time of inclusion:","Phase 1 (first trimester): Pregnant women between 9 and 15 weeks of gestation who are scheduled to undergo chorionic villus sampling (CVS) as part of the center's routine clinical practice","Phase 2 (delivery): Women with an ongoing pregnancy, regardless of gestational age and without the requirement of having participated in Phase 1, who are willing to donate placental and maternal blood samples following delivery"],"whoShouldSkip":["Women with multiple pregnancy","Non-evolving pregnancies (including delayed abortion/foetal orbit)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,084 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.039Z"},{"nctId":"NCT06233461","title":"A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase 2b, Multicenter, Randomized, Double-Blind Induction, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Oral TAK-279 in Subjects With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. The purpose of this study is to evaluate the efficacy and safety of TAK-279 versus placebo in participants with moderately to severely active Crohn's disease (CD). The main aim of this study is to learn if the 3 different doses of TAK-279 reduce bowel inflammation and ulcers in the bowel compared to the placebo after 12 weeks of treatment. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate medical problems. An endoscopy will be used to check the bowel for inflammation.\n\nThe participants will be treated with TAK-279 for 52 weeks (1 year).\n\nDuring the study, participants will visit their study clinic 15 times.","conditions":["Crohn's Disease"],"keywords":["Drug Therapy","Latitude CD, Latitude Research Program"],"interventions":[{"type":"DRUG","name":"TAK-279"},{"type":"DRUG","name":"Placebo"}],"enrollment":268,"startDate":"2024-03-05","completionDate":"2027-02-17","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \\>=19 years of age.\n2. Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI.\n3. Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD.\n\nExclusion Criteria:\n\n1. Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis.\n2. Have complications of CD that might require surgery during the study.\n3. Participants with a current ostomy.\n4. Participants who have failed 3 or more classes of advanced therapies.","locations":[{"facility":"United Medical Doctors","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Central Gastroenterology, LLP, d/b/a/ Gastro Florida","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Auzmer Research","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wellness Clinical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI PROS, Inc.","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth (Florida Hospital) Medical Group","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"USF Health Morsani Center for Advanced Healthcare","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital, The Emory Clinic","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center For Gastroenterology, P.C.","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Iowa Hospitals & Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of Louisville","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woodholme Gastroenterology Associates","city":"Glen Burnie","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BVL Clinical Research","city":"Liberty","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Las Vegas Medical Research","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai (ISMMS) - 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Roosevelta","city":"Banská Bystrica","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniq s. r. o.","city":"Bratislava","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endomed","city":"Košice","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultna Nemocnica s poliklinikou Nove Zamky","city":"Nové Zámky","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Wonju Severance Christian Hospital","city":"Wŏnju","state":"Gangwon-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inje University Haeundae Paik Hospital","city":"Busan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kosin University Gospel Hospital","city":"Busan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center (AMC)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intesto - Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital","city":"Changhua","state":"Changhua County","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital (NTUH)","city":"Taipei","state":"Zhongzheng District","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital - Cambridge University Hospitals NHS Foundation Trust","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wingate Institute for Neurogastroenterology, Wingate Clinical Trials Facility, Barts Health NHS Trust","city":"London","state":"E1 2at","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Eastern Health and Social Care Trust - The Ulster Hospital","city":"Belfast","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"NIHR UCLH Clinical Research Facility - University College London Hospitals NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Takeda Contact","phone":"+1-877-825-3327","email":"medinfoUS@takeda.com"}],"primaryOutcomes":["Percentage of Participants With Endoscopic Response Based on Simple Endoscopic Score for Crohn's Disease (SES-CD) at Week 12"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["murrieta-california","orange-california","clearwater-florida","lakeland-florida","miami-lakes-florida","naples-florida","orlando-florida","tampa-florida","atlanta-georgia","decatur-georgia","iowa-city-iowa","kansas-city-kansas","louisville-kentucky","glen-burnie-maryland","liberty-missouri","las-vegas-nevada","new-york-new-york","rochester-new-york","mentor-ohio","oklahoma-city-oklahoma","providence-rhode-island","greenville-south-carolina","bellaire-texas","dallas-texas","fort-worth-texas","kingwood-texas","mansfield-texas","san-antonio-texas","tyler-texas","seattle-washington","concord-australia","south-brisbane-australia","bedford-park-australia","woodville-australia","footscray-australia","murdoch-australia","perth-australia","epping-australia","nedlands-australia","brussels-belgium","leuven-belgium","li-ge-belgium","bras-lia-brazil","juiz-de-fora-brazil","porto-alegre-brazil","botucatu-brazil","campinas-brazil","ja-brazil","ribeir-o-preto-brazil","santos-brazil","s-o-paulo-brazil","plovdiv-bulgaria","sliven-bulgaria","sofia-bulgaria","calgary-canada","new-westminster-canada","halifax-canada","london-canada","toronto-canada","montreal-canada","chongqing-china","xiamen-china","guangzhou-china","huizhou-china","wuhan-china","changsha-china","changzhou-china","suzhou-china","shenyang-china","shanghai-china","hangzhou-china","zhejiang-china","ho-ovice-czechia","brno-czechia","esk-bud-jovice-czechia","hradec-kr-lov-czechia","ostrava-czechia","ostrava-poruba-czechia","pardubice-czechia","prague-czechia","st-nad-labem-czechia","odense-denmark","esbjerg-denmark","gistrup-denmark","hiller-d-denmark","hvidovre-denmark","k-ge-denmark","chambray-l-s-tours-france","clermont-ferrand-france","neuilly-sur-seine-france","nice-france","saint-etienne-france","vand-uvre-l-s-nancy-france","frankfurt-germany","frankfurt-am-main-germany","kiel-germany","ludwigshafen-germany","mannheim-germany","t-bingen-germany","ulm-germany","p-trai-greece","athens-greece","heraklion-greece","budapest-hungary","moh-cs-hungary","ashdod-israel","beersheba-israel","jerusalem-israel","kfar-saba-israel","ramat-gan-israel","bologna-italy","milan-italy","palermo-italy","roma-italy","rome-italy","rozzano-italy","sapporo-japan","nishinomiya-japan","morioka-japan","sendai-japan","hirakata-japan","takatsuki-shi-japan","hamamatsu-japan","minato-japan","mitaka-japan","chiba-japan","fukuoka-japan","tokyo-japan","toyama-japan","geleen-netherlands","amsterdam-netherlands","tilburg-netherlands","lorenskog-norway","oslo-norway","torun-poland","wroclaw-poland","warsaw-poland","szczecin-poland","bydgoszcz-poland","lodz-poland","lublin-poland","poznan-poland","rzesz-w-poland","sopot-poland","tychy-poland","zamo-poland","timi-oara-romania","ploie-ti-romania","bucharest-romania","ahy-slovakia","bansk-bystrica-slovakia","bratislava-slovakia","ko-ice-slovakia","nov-z-mky-slovakia","w-nju-south-korea","busan-south-korea","daegu-south-korea","seoul-south-korea","basel-switzerland","bern-switzerland","changhua-taiwan","taipei-taiwan","taichung-taiwan","cambridge-united-kingdom","london-united-kingdom","belfast-united-kingdom"],"enrichment":{"headline":"Phase 2: testing TAK-279 for Crohn's Disease","inPlainEnglish":"Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut. this study wants to measure the how well it works and safety of TAK-279 versus dummy treatment (placebo) in participants with moderately to severely active Crohn's disease (CD).","whoItsFor":["Ages 18 Years to 75 Years","Male or female aged 18-75 years old with diagnosis of CD for at least 30 days. In South Korea, the age requirement for adult participants is \\>=19 years of age","Confirmed diagnosis of moderately to severely active CD assessed by SES-CD and CDAI","Participants must have had an inadequate response to, loss of response to, or intolerance to at least one or more conventional, biologic, or advanced therapy for CD"],"whoShouldSkip":["Participants with indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, and diverticular disease associated with colitis, and/or ulcerative colitis","Have complications of CD that might require surgery during the study","Participants with a current ostomy","Participants who have failed 3 or more classes of advanced therapies"],"whatHappens":"If you join, the listed intervention(s) are TAK-279, or Placebo. The registry lists allocation as randomized. Crohn's disease (CD) is a long-lasting condition causing inflammation that can affect any part of the gut.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 268 people at 201 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.900Z"},{"nctId":"NCT06234410","title":"Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation","officialTitle":"Cardiovascular Risk Assessment For Kidney Transplantation - Utility of Computed Tomography Coronary Angiography in the Assessment of Patients Awaiting Kidney Transplantation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Edinburgh","sponsorClass":"OTHER","summary":"Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.\n\nCurrent strategies to assess patient's cardiovascular risk prior to kidney transplantation do not identify those at highest risk and do not improve outcomes.\n\nThis study will use a heart scan known as computed tomography coronary angiography (CTCA) to see whether this scan can identify patients at highest risk of future cardiovascular disease prior to transplantation. Studies have shown it is able to do this in patients with normal kidney function.\n\nThe aim of this study is to develop CTCA as an effective tool to risk stratify patients prior to kidney transplantation.","conditions":["Cardiovascular Diseases","Kidney Transplant; Complications"],"keywords":["Coronary artery disease","Kidney transplantation","Cardiovascular risk assessment","Heart disease","Chronic kidney disease"],"interventions":[{"type":"RADIATION","name":"Computed tomography coronary angiography (CTCA)"}],"enrollment":332,"startDate":"2024-01-24","completionDate":"2032-01","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has kidney failure and is on the waitlist for a kidney transplant\n* Age 16 years and over\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Contraindication to CT scanning, including contrast allergy\n* Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation\n* Inability to give informed consent","locations":[{"facility":"Royal Infirmary of Edinburgh","city":"Edinburgh","state":"Lothian","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Plymouth NHS Trust","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Teaching Hospitals NHS Trust","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gavin B Chapman, MBChB","phone":"00447713349318","email":"gchapma2@ed.ac.uk"},{"name":"Neeraj Dhaun, MBChB","phone":"","email":"bean.dhaun@ed.ac.uk"}],"primaryOutcomes":["Number of participants who have either a myocardial infarction or cardiovascular death"],"hasResults":false,"conditionSlugs":["stroke","chronic-kidney-disease","heart-failure"],"drugSlugs":[],"locationSlugs":["edinburgh-united-kingdom","glasgow-united-kingdom","london-united-kingdom","plymouth-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Computed tomography coronary angiography (CTCA) for Cardiovascular Diseases","inPlainEnglish":"Cardiovascular disease (for example, heart attack, stroke, heart failure) is the commonest complication of kidney failure. Kidney transplantation reduces cardiovascular risk but cardiovascular disease remains the commonest cause of death in patients following transplantation.","whoItsFor":["Ages 16 Years to any","Has kidney failure and is on the waitlist for a kidney transplant","Age 16 years and over"],"whoShouldSkip":["Contraindication to CT scanning, including contrast allergy","Patients being considered for a simultaneous kidney-pancreas, kidney-liver and/or kidney-islet transplantation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 332 people at 5 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.497Z"},{"nctId":"NCT06237452","title":"VE303 for Prevention of Recurrent Clostridioides Difficile Infection","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of VE303 for Prevention of Recurrent Clostridioides Difficile Infection","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Vedanta Biosciences, Inc.","sponsorClass":"INDUSTRY","summary":"The overall objective of the RESTORATiVE303 study is to evaluate the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching placebo. The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).","conditions":["Clostridium Difficile","Clostridium Difficile Infections","Clostridium Difficile Infection Recurrence","Clostridioides Difficile Infection","Clostridioides Difficile Infection Recurrence","CDI","C. Diff Infection","Recurrent Clostridium Difficile Infection","C.Difficile Diarrhea","Diarrhea Infectious"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"VE303"},{"type":"BIOLOGICAL","name":"Placebo"}],"enrollment":852,"startDate":"2024-05-20","completionDate":"2027-06","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria (For enrollment in Stage 1: recurrent CDI population):\n\n* Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months\n\nKey Inclusion Criteria (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):\n\n* Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI\n* OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:\n\n  1. Age ≥ 65 years\n  2. Kidney dysfunction, defined as estimated creatinine clearance \\< 60 mL/min/1.73 m\\^2 at the time of the qualifying CDI episode\n  3. History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study\n  4. History of a prior CDI episode between 6 and 12 months prior to enrollment\n  5. Immunosuppression due to an underlying disease or its treatment\n  6. Has undergone solid organ or hematopoietic stem cell transplantation\n\nKey Inclusion Criteria (For enrollment in Stage 1 or 2):\n\n* The qualifying episode of CDI must meet all the following criteria:\n\n  1. New onset of ≥ 3 unformed bowel movements (ie, Types 5 to 7 on the Bristol stool scale) within 24 hours for 2 consecutive days\n  2. CDI symptoms started within 4 weeks prior to initiation of standard of care (SoC) antibiotic therapy for CDI\n  3. Stool sample collected before (or no later than 72 hours after) initiation of SoC antibiotic therapy that was positive in a CDI laboratory test, defined as enzyme immunoassay (EIA) for toxin A/B and glutamate dehydrogenase (GDH) with polymerase chain reaction (PCR) reflex testing for discordant EIA/GDH results, performed at either a local laboratory or the central laboratory\n  4. Diarrhea considered unlikely to have another etiology\n* Prior to receiving any study medication, the participant should:\n\n  1. Receive and complete a course of SoC antibiotic therapy for at least 10 days, up to a maximum of 28 days (Note: choice of agent is at the physician's discretion and antibiotic tapering is not allowed). It is permissible for decentralized participants to be randomized during SoC antibiotic administration.\n  2. Meet the criterion of a successful clinical response, defined attaining symptomatic control of the qualifying CDI episode, ie, \\< 3 loose/unformed bowel movements per 24 hours for at least 2 consecutive days\n* Able to receive the first dose of study drug on the last planned day of SoC antibiotic administration for a qualifying CDI episode, or no later than 2 days after completion of antibiotic dosing\n* Recovered from any complications of severe or fulminant CDI and be clinically stable by the time of randomization\n\nKey Exclusion Criteria (For both Stage 1 and Stage 2):\n\n* History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI\n* Known or suspected toxic megacolon or small bowel ileus at the time of randomization\n* History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis\n* Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode\n* Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug\n* Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)\n* Probiotics, whether characterized as a dietary/food supplement, or a drug, are prohibited within 2 days before starting study drug and through the dosing period. 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3: testing VE303 for Clostridium Difficile","inPlainEnglish":"The overall objective of the RESTORATiVE303 study is to measure the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching dummy treatment (placebo). The objectives and endpoints are identical for Stage 1 (recurrent CDI) and Stage 2 (high-risk primary CDI).","whoItsFor":["Ages 12 Years to any","Key (For enrollment in Stage 1: recurrent CDI population):","Age ≥ 12 years where permitted, and ≥ 18 years in other locations, with a laboratory-confirmed qualifying episode of CDI and at least 1 prior occurrence within the last 6 months","Key who can join (For enrollment in Stage 2: primary CDI with high-risk for recurrence population):","Age ≥ 75 years with a laboratory-confirmed qualifying episode of CDI","OR age ≥ 12 years where permitted, and ≥ 18 years in other locations, with least two of the following risk factors:","Kidney dysfunction, defined as estimated creatinine clearance \\< 60 mL/min/1.73 m\\^2 at the time of the qualifying CDI episode","History of regular use of a proton pump inhibitor (PPI) within the past 2 months and expectation of continued use of PPIs throughout the study"],"whoShouldSkip":["(For both Stage 1 and Stage 2):","History of chronic diarrhea (defined as ≥ 3 loose stools per day lasting for at least 4 weeks) within 3 months prior to randomization that is not related to CDI","Known or suspected toxic megacolon or small bowel ileus at the time of randomization","History of confirmed celiac disease, inflammatory bowel disease, microscopic colitis, short gut, GI tract fistulas, or a recent episode (within 6 months of screening) of intestinal ischemia or ischemic colitis","Receipt of bezlotoxumab during the course of SoC antibiotic treatment for the qualifying CDI episode","Use of antidiarrheal drugs (eg, loperamide, diphenoxylate) within 3 days prior to the planned first dose of study drug","Anticipated administration of oral or parenteral antibacterial therapy for a non-CDI indication after randomization through Week 24 (end of study)"],"whatHappens":"If you join, the listed intervention(s) are VE303, or Placebo. The registry lists allocation as randomized. The overall objective of the RESTORATiVE303 study is to measure the safety and the Clostridioides difficile infection (CDI) recurrence rate at Week 8 in participants who receive a 14-day course of VE303 or matching dummy treatment (placebo).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 852 people at 215 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.429Z"},{"nctId":"NCT06241781","title":"Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","officialTitle":"A Phase 2, Multicenter Randomized Controlled Open-label Study of Autologous Tumor Infiltrating Lymphocytes (GT101 Injection) in Patients With Recurrent or Metastatic Cervical Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Grit Biotechnology","sponsorClass":"INDUSTRY","summary":"This is a Phase II, multicenter, open-label, randomized, parallel group, treatment study to assess the efficacy and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.","conditions":["Recurrent or Metastatic Cervical Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"GT101"},{"type":"DRUG","name":"Gemcitabine injection"},{"type":"BIOLOGICAL","name":"IL-2"}],"enrollment":100,"startDate":"2024-04-02","completionDate":"2027-01-31","sex":"FEMALE","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Voluntarily enroll in the study, sign the informed consent form, and be willing and able to comply with the study protocol.\n* 2\\. Aged ≥18 years and ≤70 years.\n* 3\\. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment.\n* 4\\. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs).\n* 5\\. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1.\n* 6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* 7\\. Expected survival ≥12 weeks.\n* 8\\. Adequate normal organ and bone marrow function.\n* 9\\. Serum human chorionic gonadotropin (HCG) test must be negative within 7 days prior to TIL infusion for women of childbearing potential without surgical sterilization.\n* 10\\. Adverse events from prior therapies must have recovered to Grade ≤1 (per CTCAE 5.0) before tumor sampling.\n* 11\\. Participants entering this study due to disease progression must have radiological documentation of disease progression following the last prior treatment before tumor resection.\n\nExclusion Criteria:\n\n* 1\\. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary.\n* 2\\. Uncontrolled tumor-related pain as judged by the investigator.\n* 3\\. Bleeding events occurring within 3 months prior to screening.\n* 4\\. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc.\n* 5\\. Respiratory diseases that substantially impair pulmonary function.\n* 6\\. History of clinically significant cardiovascular disease.\n* 7\\. Participants with untreated central nervous system (CNS) metastatic lesions at screening.\n* 8\\. Active autoimmune disease requiring systemic corticosteroids or immunosuppressive therapy.\n* 9\\. Malignancies other than the target indication diagnosed within 5 years before screening.\n* 10\\. Refractory/intractable epilepsy, medically uncontrolled pleural effusion, etc.\n* 11\\. Infectious diseases within 1 year prior to screening.\n* 12\\. Use of anti-angiogenic agents within 4 weeks before sampling.\n* 13\\. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.\n* 14\\. Systemic anti-tumor therapy administered within 4 weeks prior to lymphodepleting chemotherapy.\n* 15\\. Prior receipt of genetically modified or edited cellular therapy products.\n* 16\\. History of allergic reaction to any component of the investigational agents to be used in this study.\n* 17\\. Known psychiatric disorders, alcohol abuse, illicit drug use, or substance abuse.\n* 18\\. Prior immunotherapy associated with Grade ≥3 immune-related adverse events (irAEs) that failed to recover to CTCAE Grade 1 or lower within 28 days.\n* 19\\. Pregnant or lactating women, or women planning pregnancy, gestation or lactation within 1 year after cell infusion.\n* 20\\. Receipt of other investigational medicinal products within 4 weeks prior to randomization, or plan to receive other investigational medicinal products during the study.\n* 21\\. Other conditions judged unsuitable for enrollment by the investigator.","locations":[{"facility":"Beijing Obstetrics and Gynecology Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fifth Medical Center of the General Hospital of the People's Liberation Army of China","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Army Medical Center of PLA","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Cancer Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gansu Provincial Cancer 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University","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liaoning Cancer Hospital","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong First Medical University Affiliated Cancer Hospital","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jining First People's Hospital","city":"Jining","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Affiliated Obstetrics and Gynecology Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Cancer Hospital","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi’an","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan University West China Second Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yibin Second People's Hospital","city":"Yibin","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Cancer Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yunnan Cancer Hospital","city":"Kunming","state":"Yunnan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"XiaoHua Wu, PHD","phone":"+86-21-64175590","email":"wu.xh@fudan.edu.cn"},{"name":"Jing Wang, PHD","phone":"","email":"wangjing0081@126.com"}],"primaryOutcomes":["Progression Free Survival (PFS) (per RECIST V.1.1) by IRC assessment"],"hasResults":false,"conditionSlugs":["cervical-cancer"],"drugSlugs":[],"locationSlugs":["beijing-china","chongqing-china","fuzhou-china","lanzhou-china","guangzhou-china","shenzhen-china","guilin-china","haerbin-china","luoyang-china","zhengzhou-china","wuhan-china","changsha-china","nanjing-china","nanchang-china","dalian-china","shenyang-china","jinan-china","jining-china","shanghai-china","taiyuan-china","xian-china","chengdu-china","yibin-china","tianjin-china","kunming-china","hangzhou-china"],"enrichment":{"headline":"Phase 2: testing GT101 for Recurrent or Metastatic Cervical Cancer","inPlainEnglish":"This is a Phase II, multicenter, open-label, randomly assigned, parallel group, treatment study to assess the how well it works and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.","whoItsFor":["Ages 18 Years to 70 Years","Women only","2\\. Aged ≥18 years and ≤70 years","3\\. Recurrent or metastatic cervical cancer: have received prior adequate first-line systemic therapy with radiologically confirmed disease progression during or after treatment","4\\. Have at least one resectable tumor lesion for the manufacture of autologous tumor-infiltrating lymphocytes (TILs)","5\\. Apart from the sampling lesion(s), have at least one measurable lesion per RECIST 1.1","6\\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","7\\. Expected survival ≥12 weeks","8\\. Adequate normal organ and bone marrow function"],"whoShouldSkip":["1\\. Spinal cord compression not relieved by surgery and/or radiotherapy is exclusionary","2\\. Uncontrolled tumor-related pain as judged by the investigator","3\\. Bleeding events occurring within 3 months prior to screening","4\\. Arterial or venous thromboembolic events within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (DVT), pulmonary embolism (PE), etc","5\\. Respiratory diseases that substantially impair pulmonary function","6\\. History of clinically significant cardiovascular disease","7\\. Participants with untreated central nervous system (CNS) metastatic lesions at screening"],"whatHappens":"If you join, the listed intervention(s) are GT101, Gemcitabine injection, or IL-2. The registry lists allocation as randomized. This is a Phase II, multicenter, open-label, randomly assigned, parallel group, treatment study to assess the how well it works and safety of Autologous Tumor Infiltrating Lymphocytes (GT101 injection) compared with Gemcitabine in participants with recurrent or metastatic cervical cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at 38 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.331Z"},{"nctId":"NCT06242470","title":"A Study of MGC026 in Participants With Advanced Solid Tumors","officialTitle":"A Phase 1/1b First-in-Human, Open Label, Dose Escalation and Cohort Expansion Study of MGC026 in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"MacroGenics","sponsorClass":"INDUSTRY","summary":"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion. The dose of vobramitamab tavatecan will be assigned at the time of enrollment. Pembrolizumab will be administered at 200 mg every 3 weeks. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood and tumor samples collected for research purposes.","conditions":["Advanced Solid Tumor","Advanced Cancer","Metastatic Cancer","Squamous Cell Carcinoma of Head and Neck","Non Small Cell Lung Cancer","Small-cell Lung Cancer","Bladder Cancer","Sarcoma","Endometrial Cancer","Melanoma","Castration Resistant Prostatic Cancer","Cervical Cancer","Colorectal Cancer","Gastric Cancer","Gastro-esophageal Cancer","Pancreas Cancer","Clear Cell Renal Cell Carcinoma","Hepatocellular Carcinoma","Platinum-resistant Ovarian Cancer","Breast Cancer","Ovarian Cancer","Esophageal Squamous Cell Cancer (SCC)"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MGC026 Dose Escalation"},{"type":"BIOLOGICAL","name":"MGC026 Dose for Expansion"},{"type":"BIOLOGICAL","name":"Pembrollizumab"},{"type":"BIOLOGICAL","name":"vobramitamab tavatecan"}],"enrollment":394,"startDate":"2024-03-06","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥ 18 years old, able to provide informed consent\n* Adequate performance and laboratory parameters\n* Availability of archival or formalin-fixed paraffin-embedded tumor tissue sample. Participants may undergo a fresh tumor biopsy to obtain a specimen for testing if an archival tumor sample is not available. Participants with no available archival tissue sample who cannot safely undergo a fresh biopsy as determined by consultation between the sponsor and investigator are eligible\n* Unresectable, locally advanced or metastatic solid tumors including: squamous cell cancer (SCC) of the head and neck, esophageal SCC, squamous and non-squamous non-small cell lung cancer, small cell lung cancer, bladder cancer, sarcoma, endometrial cancer, melanoma, castration resistant prostate cancer, breast cancer, ovarian cancer, cervical cancer, colorectal cancer gastric or gastroesophageal cancer, pancreatic carcinoma, clear cell renal cell cancer or hepatocellular cancer.\n* Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible.\n* Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026.\n* Not pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.\n* Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\< 6), or carcinoma in situ.\n* Patients with history of prior central nervous system (CNS) metastasis must have been treated, be asymptomatic, and not have concurrent treatment for CNS disease, progression of CNS metastases on magnetic resonance imaging, computed tomography or positron emission tomography, or history of leptomeningeal disease or cord compression at the time of enrollment.\n* Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals.\n* Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload.\n* Prior autologous or allogeneic stem cell or solid organ transplant.\n* Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders.\n* Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration.\n* Known history of hepatitis B or C infection or known positive test for hepatitis B surface antigen or core antigen, or hepatitis C polymerase chain reaction.\n* Known positive testing for human immunodeficiency virus or history of acquired immune deficiency syndrome.\n* History of primary immunodeficiency.\n* Major trauma or major surgery within 4 weeks of first study drug administration.\n* Known hypersensitivity to recombinant proteins.","locations":[{"facility":"The Angeles Clinic and Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START-New York Long Island","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Cancer Institute","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre Wesley","city":"Auchenflower","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre Kurralta Park","city":"Kurralta Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Health- Olivia Newton John Cancer Center","city":"Heidelberg","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals NHS Foundation Trust","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden NHS Foundation Trust","city":"Sutton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Global Trial Manager","phone":"301-251-5172","email":"info@macrogenics.com"}],"primaryOutcomes":["Number of participants with adverse events (AEs) and serious AEs (SAEs), AEs leading to dose delay, AEs leading to dose reduction, AEs leading to treatment discontinuations, AEs meeting criteria for dose limiting toxicity, and AEs of special interest."],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","melanoma","ovarian-cancer","kidney-cancer","bladder-cancer","liver-cancer","stomach-cancer","cervical-cancer","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["los-angeles-california","grand-rapids-michigan","lake-success-new-york","portland-oregon","houston-texas","west-valley-city-utah","auchenflower-australia","kurralta-park-australia","heidelberg-australia","oxford-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing MGC026 Dose Escalation for Advanced Solid Tumor","inPlainEnglish":"The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study. Combination therapy with pembrolizumab will occur in Module B of the study Participants will receive vobramitamab tavatecan by intravenous (IV) infusion.","whoItsFor":["Ages 18 Years to any","Adequate performance and laboratory parameters","Measurable disease per RECIST v1.1. Participants with metastatic CRPC without measurable disease are eligible","Must be willing to use highly effective methods of birth control from the time of consent through 7 months after discontinuation of MGC026","Not pregnant or breastfeeding"],"whoShouldSkip":["Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures","Another cancer that required treatment within the past 2 years, with the exception of those with low risk of cancer spreading or death such as adequately treated non melanomatous skin cancer, localized prostate cancer (Gleason Score \\< 6), or carcinoma in situ","Treatment with surgery, systemic cancer therapy, immunotherapy, chimeric antigen receptor-T therapy, or anti-hormonal within protocol specified intervals","Prior treatment with any B7-H3 targeted agent for cancer or any ADC with a topoisomerase payload","Prior autologous or allogeneic stem cell or solid organ transplant","Clinically significant cardiovascular, pulmonary, or gastrointestinal disorders","Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 1 week of first study drug administration"],"whatHappens":"If you join, the listed intervention(s) are MGC026 Dose Escalation, MGC026 Dose for Expansion, or Pembrollizumab. The registry lists allocation as randomized. The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of vobramitamab tavatecan (MGC026) in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion in Module A of the study.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 394 people at 12 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.630Z"},{"nctId":"NCT06246916","title":"A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)","officialTitle":"A Phase 3 Study of Fixed Dose Combinations of Fianlimab and Cemiplimab Versus Relatlimab and Nivolumab in Participants With Unresectable or Metastatic Melanoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called \"study drugs\". The study is focused on patients with a type of skin cancer known as melanoma. The aim of the study is to see how safe and effective the combination of fianlimab and cemiplimab is in treating melanoma, in comparison with the combination of two medications, relatlimab and nivolumab, commercialized under the brand name Opdualag™ and approved for the treatment of melanoma in adults and children.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs.\n* How much study drug is in the blood at different times.\n* Whether the body makes antibodies against the study drugs (which could make the drug less effective or could lead to side effects)","conditions":["Melanoma"],"keywords":["Unresectable Melanoma","Metastatic Melanoma","Advanced Melanoma","Stage III","Stage IV"],"interventions":[{"type":"DRUG","name":"fianlimab"},{"type":"DRUG","name":"cemiplimab"},{"type":"DRUG","name":"relatlimab+nivolumab"}],"enrollment":560,"startDate":"2024-09-09","completionDate":"2027-03-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition.\n2. Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol.\n3. Measurable disease per RECIST version 1.1.\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n5. Adequate bone marrow, hepatic, and kidney function\n6. Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol\n\nKey Exclusion Criteria:\n\nMedical Conditions:\n\n1. Uveal, acral or mucosal melanoma.\n2. Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol.\n3. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C virus (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection. Mild cancer-related immunodeficiency (such as immunodeficiency treated with gamma globulin and without chronic or recurrent infection) is allowed.\n\n   Prior/Concomitant Therapy:\n4. Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol\n5. Systemic immune suppression as described in the protocol.\n\n   Other Comorbidities:\n6. Participants with a history of myocarditis.\n7. Troponin T (TnT) or troponin I (TnI) \\>2x institutional upper limit of normal (ULN).\n8. Active or untreated brain metastases or spinal cord compression as described in the protocol.\n\nNote: Other protocol-defined Inclusion/ Exclusion Criteria apply.","locations":[{"facility":"Ironwood Cancer & Research Centers","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Oncology Associates","city":"Tucson","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer and Blood Specialty Clinic","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Hospital Orange","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine, UCI Medical Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eisenhower Medical Center","city":"Rancho Mirage","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Emad Ibrahim, MD, Inc.","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco (UCSF)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sansum Clinic","city":"Santa Barbara","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"St John's Cancer Institute","city":"Santa Monica","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rocky Mountain Regional VA Medical Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Melanoma And Skin Cancer Institute","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth","city":"Fort Collins","state":"Colorado","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clermont Oncology Center","city":"Clermont","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Specialist of North Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Boca Raton Clinical Research (BRCR) Global","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. 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The study is focused on patients with a type of skin cancer known as melanoma.","whoItsFor":["Ages 18 Years to any","Participants with histologically confirmed unresectable stage III and stage IV (metastatic) melanoma per American Joint Committee on Cancer (AJCC), eighth revised edition","Participants must not have received prior systemic therapy for unresectable or metastatic melanoma as described in the protocol","Measurable disease per RECIST version 1.1","Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1","Adequate bone marrow, hepatic, and kidney function","Known B-Rapidly Accelerated Fibrosarcoma protein (BRAF) V600 mutation status or submitted sample for BRAF V600 mutation assessment as described in the protocol"],"whoShouldSkip":["Medical Conditions:","Uveal, acral or mucosal melanoma","Ongoing or recent (within 2 years) evidence of an autoimmune disease that required systemic treatment with immunosuppressive agents as described in the protocol","Prior/Concomitant Therapy:","Prior immune checkpoint inhibitor therapy other than anti-PD1/PD-L1 as described in the protocol","Systemic immune suppression as described in the protocol","Other Comorbidities:"],"whatHappens":"If you join, the listed intervention(s) are fianlimab, cemiplimab, or relatlimab+nivolumab. The registry lists allocation as randomized. This study is researching an experimental drug called fianlimab (also known as REGN3767), combined with another medication called cemiplimab (also known as REGN2810), called \"study drugs\".","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 560 people at 113 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.803Z"},{"nctId":"NCT06247085","title":"Pegtibatinase as a Treatment for Participants With Classical Homocystinuria (HCU) Receiving Standard of Care Treatment","officialTitle":"A Phase 3, Parallel-Group Treatment, Blinded, Randomized, Placebo-Controlled Study To Assess The Efficacy And Safety Of Pegtibatinase Administered Subcutaneously In Addition To Standard Of Care In Participants With Classical Homocystinuria Due To Cystathionine Beta Synthase Deficiency (HARMONY)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Travere Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"Researchers are looking for a better way to treat people living with classical homocystinuria (HCU), a rare inherited condition. It is caused by changes in the cystathionine beta-synthase (or \"CBS\") gene and prevents an enzyme from working correctly in the body. This enzyme helps break down homocysteine, which is produced when the body processes methionine from protein-containing foods. This helps keep homocysteine and methionine at healthy levels. When this enzyme is not working, homocysteine and methionine build up in the blood and then spread into different tissues of the body and stop these body tissues from working normally.\n\nPeople living with HCU can experience problems with their vision, bones, blood vessels, thinking, learning, and memory. Available treatments for HCU include a low-methionine diet (typically achieved by limiting protein-containing foods), a methionine-free protein supplement to help meet daily protein needs, and betaine (Cystadane®). These treatments are either not sufficient or are hard to take for many patients.\n\nPegtibatinase was designed by researchers to act like the CBS enzyme, which is missing or not working properly in people living with HCU. Researchers are studying whether adding pegtibatinase to standard treatment can lower homocysteine levels.\n\nResearchers want to learn how safe and effective pegtibatinase is, how it moves through and affects the body, and how it may affect the daily lives of people with HCU.\n\nThe study plans to enroll participants from the US, Australia, Belgium, France, Germany, Ireland, Italy, Poland, Portugal, Qatar, Saudi Arabia, Spain, Turkey, and the United Kingdom. Many study visits may happen at home, depending on where you live and local regulations. Some visits may include a home nurse and telemedicine appointments with the study doctor.","conditions":["Homocystinuria"],"keywords":["HCU","cystathionine beta synthase deficiency","Classical Homocystinuria"],"interventions":[{"type":"DRUG","name":"Pegtibatinase"},{"type":"OTHER","name":"Placebo"}],"enrollment":70,"startDate":"2023-12-28","completionDate":"2027-08","sex":"ALL","minAge":"12 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be ≥12 to ≤65 years of age, at the time of signing the informed consent\n* Must have a diagnosis of classical HCU based on clinical, biochemical, and/or molecular genetic testing\n* Plasma tHcy ≥80 µM at Screening visit, with allowance for up to 18 participants who may be enrolled with a Screening plasma tHcy ≥50 to \\<80 µM\n* Participants who can become pregnant must have a negative pregnancy test before starting the study and must use a highly effective form of birth control (less than 1% risk of pregnancy per year) during the study and for at least 4 weeks after the last dose.\n* Willing to maintain a generally stable diet for the duration of the study (unless changes are required based on medical/safety reasons)\n* Willing to maintain generally stable intake and doses of betaine, pyridoxine, and medical food for the duration of the study (unless changes are required based on medical/safety reasons)\n\nExclusion Criteria:\n\n* Diagnosis of Marfan syndrome, methylenetetrahydrofolate reductase (MTHFR) deficiency, or disorder of cobalamin metabolism\n* Concurrent disease or condition (eg, history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurological, oncologic, or psychiatric disease) that would interfere with study participation or safety (excluding complications of HCU).\n* History of major thrombotic event (eg, cerebrovascular accident, myocardial infarction, pulmonary embolism) in the previous 6 months.\n* Body weight ≥160 kg.\n* Use or planned use of any injectable drugs containing PEG (excluding PEG-containing vaccines)\n* Any previous exposure to pegtibatinase and/or previous participation in a clinical study that included administration of pegtibatinase or pegtarviliase\n* Prior severe immune reaction to a PEG-containing product","locations":[{"facility":"Phoenix Children's Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann & Robert H. 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Hôpitaux de Paris (AP-HP) - Hôpital Necker-Enfants Malades","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU Hôpitaux de Tours - Hôpital Bretonneau","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Régional Universitaire de Nancy (CHRU) - Hopitaux de Brabois - Hôpital d'enfants","city":"Vandœuvre-lès-Nancy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Leipzig","city":"Leipzig","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Health Ireland (CHI) at Temple Street","city":"Dublin","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Giovanni XXIII","city":"Bari","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Giannina Gaslini","city":"Genova","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Policlinico di Milano)","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo Dei Tintori - Ospedale San Gerardo","city":"Monza","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera di Padova","city":"Padova","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"SP ZOZ Szpital Uniwersytecki w Krakowie","city":"Krakow","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instytut Matki i Dziecka","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instytut Pomnik-Centrum Zdrowia Dziecka","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saúde de Coimbra, EPE - Hospitais da Universidade de Coimbra","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saúde de Santa Maria, EPE - Hospital de Santa Maria","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saúde de São João, EPE - Hospital São João","city":"Porto","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hamad General Hospital","city":"Doha","state":"","country":"Qatar","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sidra Hospital","city":"Doha","state":"","country":"Qatar","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Abdullah International Medical Research Center","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Faisal Specialist Hospital and Research Centre (KFSHRC) - Riyadh","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Déu","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramón y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Santiago (CHUS) - Hospital Clínico Universitario","city":"Santiago de Compostela","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocío","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gazi University Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ege Üniversitesi Hastanesi Bornova","city":"Bornova","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istanbul University Cerrahpasa Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Women's and Children's NHS Foundation Trust","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals NHS Foundation Trust - National Hospital for Neurology and Neurosurgery","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Salford Royal NHS Foundation Trust - Salford Royal Hospital","city":"Salford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Travere Call Center","phone":"1-877-659-5518","email":"medinfo@travere.com"}],"primaryOutcomes":["Change from baseline in plasma tHcy levels - Weeks 6 to 12"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","new-haven-connecticut","atlanta-georgia","chicago-illinois","portland-maine","chevy-chase-maryland","new-york-new-york","morrisville-north-carolina","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","dallas-texas","salt-lake-city-utah","adelaide-australia","parkville-australia","westmead-australia","brussels-belgium","edegem-belgium","paris-france","tours-france","vand-uvre-l-s-nancy-france","hamburg-germany","leipzig-germany","m-nster-germany","dublin-ireland","bari-italy","genova-italy","milan-italy","monza-italy","padova-italy","krakow-poland","warsaw-poland","coimbra-portugal","lisbon-portugal","porto-portugal","doha-qatar","riyadh-saudi-arabia","barcelona-spain","madrid-spain","santiago-de-compostela-spain","seville-spain","ankara-turkey-t-rkiye","bornova-turkey-t-rkiye","istanbul-turkey-t-rkiye","birmingham-united-kingdom","london-united-kingdom","salford-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Pegtibatinase for Homocystinuria","inPlainEnglish":"Researchers are looking for a better way to treat people living with classical homocystinuria (HCU), a rare inherited condition. It is caused by changes in the cystathionine beta-synthase (or \"CBS\") gene and prevents an enzyme from working correctly in the body.","whoItsFor":["Ages 12 Years to 65 Years","Must have a diagnosis of classical HCU based on clinical, biochemical, and/or molecular genetic testing","Plasma tHcy ≥80 µM at Screening visit, with allowance for up to 18 participants who may be enrolled with a Screening plasma tHcy ≥50 to \\<80 µM","Participants who can become pregnant must have a negative pregnancy test before starting the study and must use a highly effective form of birth control (less than 1% risk of pregnancy per year) during the study and for at least 4 weeks after the last dose","Willing to maintain a generally stable diet for the duration of the study (unless changes are required based on medical/safety reasons)","Willing to maintain generally stable intake and doses of betaine, pyridoxine, and medical food for the duration of the study (unless changes are required based on medical/safety reasons)"],"whoShouldSkip":["Diagnosis of Marfan syndrome, methylenetetrahydrofolate reductase (MTHFR) deficiency, or disorder of cobalamin metabolism","History of major thrombotic event (eg, cerebrovascular accident, myocardial infarction, pulmonary embolism) in the previous 6 months","Body weight ≥160 kg","Use or planned use of any injectable drugs containing PEG (excluding PEG-containing vaccines)","Any previous exposure to pegtibatinase and/or previous participation in a clinical study that included administration of pegtibatinase or pegtarviliase","Prior severe immune reaction to a PEG-containing product"],"whatHappens":"If you join, the listed intervention(s) are Pegtibatinase, or Placebo. The registry lists allocation as randomized. Researchers are looking for a better way to treat people living with classical homocystinuria (HCU), a rare inherited condition.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 70 people at 52 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.368Z"},{"nctId":"NCT06249282","title":"Carfilzomib in Combination With Sotorasib for the Treatment of Patients With KRAS G12C Mutated Advanced or Metastatic Non-small Cell Lung Cancer","officialTitle":"A Phase I Clinical Trial of Carfilzomib in Combination With Sotorasib in Patients With KRASG12C Mutated Advanced Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Carfilzomib is a drug that binds to and inhibits the activity of the protein complex that is responsible for degrading other damaged or unneeded proteins. The inhibition of this protein by carfilzomib can then cause tumor growth inhibition and cell death. Sotorasib is a drug that binds to and inhibits the activity of the KRAS G12C mutant. This may inhibit growth in KRAS G12C-expressing tumor cells. Combining carfilzomib and sotorasib may be a safe and effective treatment option for patients with KRAS G12C-mutated advanced or metastatic NSCLC.","conditions":["Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Carfilzomib"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Sotorasib"}],"enrollment":15,"startDate":"2024-04-24","completionDate":"2026-11-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Histologically confirmed NSCLC that is metastatic or advanced. The tumor must exhibit evidence of KRASG12C mutation which is determined by either a Clinical Laboratory Improvement Act (CLIA) certified ctDNA assay or by a CLIA certified tumor tissue assay\n* Measurable disease by RECIST v1.1\n* Failed prior KRAS inhibitor\n* Fully recovered from the acute toxic effects (except alopecia) from prior anti-cancer therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Absolute neutrophil count (ANC) ≥ 1,500/mm\\^3 (performed within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement\n* Hemoglobin (Hb) ≥ 9 g/dL (performed within 14 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000/mm\\^3 (performed within 14 days prior to day 1 of protocol therapy)\n\n  * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 3 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (or ≤ 5 x ULN in the setting of liver metastatic disease) (performed within 14 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≤ 1.5 x ULN or glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\\^2 (performed within 14 days prior to day 1 of protocol therapy)\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (performed within 14 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy\n* Radiation therapy within 14 days prior to day 1 of protocol therapy\n* KRAS inhibitor within 14 days prior to day 1 of protocol therapy\n* Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)\n* Inability to previously tolerate (240 mg, QD) sotorasib\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Evidence of chronic hepatitis B virus (HBV) infection and HBV viral load detectable\n* Evidence of untreated chronic hepatitis C virus (HCV) infection. Patients with HCV infection currently on treatment are eligible if they have an undetectable HCV viral load\n* Active infection requiring antibiotics (not to be completed by day 1 of protocol therapy)\n* Known history of immunodeficiency virus (HIV) with detectable viral load\n* Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* New York Heart Association (NYHA) class III or IV heart failure, myocardial infarction in the preceding 6 months, conduction abnormalities uncontrolled by medications\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of dose limiting toxicities","Incidence of grade 3 and 4 treatment-related toxicities"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["duarte-california","irvine-california"],"enrichment":{"headline":"Phase 1: testing Carfilzomib for Advanced Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Carfilzomib is a drug that binds to and inhibits the activity of the protein complex that is responsible for degrading other damaged or unneeded proteins.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) ≤ 2","Histologically confirmed NSCLC that is metastatic or advanced. The tumor must exhibit evidence of KRASG12C mutation which is determined by either a Clinical Laboratory Improvement Act (CLIA) certified ctDNA assay or by a CLIA certified tumor tissue assay","Measurable disease by RECIST v1.1","Failed prior KRAS inhibitor","Fully recovered from the acute toxic effects (except alopecia) from prior anti-cancer therapy","Absolute neutrophil count (ANC) ≥ 1,500/mm\\^3 (performed within 14 days prior to day 1 of protocol therapy)","NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement"],"whoShouldSkip":["Chemotherapy or immunotherapy within 21 days prior to day 1 of protocol therapy","Radiation therapy within 14 days prior to day 1 of protocol therapy","KRAS inhibitor within 14 days prior to day 1 of protocol therapy","Investigational therapy within 28 days prior to day 1 of protocol therapy (or 5 half-lives, use whichever is shorter)","Inability to previously tolerate (240 mg, QD) sotorasib","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent","Clinically significant uncontrolled illness"],"whatHappens":"If you join, the listed intervention(s) are Biopsy, Biospecimen Collection, or Carfilzomib. The registry lists allocation as na. This phase I trial tests the safety, side effects, and best dose of carfilzomib in combination with sotorasib in treating patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC) that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.973Z"},{"nctId":"NCT06249867","title":"A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS","officialTitle":"A Randomized, Double-blind, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 15 mg of Darifenacin Daily in Patients With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Oliver Blanchard","sponsorClass":"OTHER","summary":"Amyotrophic lateral sclerosis (ALS) is a progressive neurological disorder characterized by selective death of upper and lower motor neurons, which leads to severe disability and fatal outcomes. One of the major hallmarks of ALS is the denervation of neuromuscular junctions (NMJs), which is one of the earliest events seen in ALS patients and mouse models of ALS. Under healthy conditions, glial cells called Perisynaptic Schwann Cells (PSCs) have a key role in regulating the stability and maintenance of NMJs, but they only participate in NMJ repair once denervation occurs. Denervation and the subsequent decline in synaptic activity triggers a loss of muscarinic acetylcholine receptors (mAChRs) in the PSC, and the resulting decrease in mAChR-mediated gene expression drives the \"repair mode\" of the PSC. In assessing the NMJ under conditions of ALS, a scarcity of process extensions in PSCs was observed for months prior to disease onset in the superoxide dismutase 1 (SOD1) mouse model of ALS, indicating inadequate glial repair. Collectively, these preclinical findings support the hypothesis that dampening glial mAChRs will restore the anticipated \"repair\" response of PSCs in the NMJ. Hence, the use of a selective M3 muscarinic receptor antagonist, Darifenacin, as a disease-modifying therapeutic in familial and sporadic ALS could improve NMJ function, resulting in a beneficial impact on the autonomy and quality of life of ALS patients.\n\nThe purpose of the current Phase 2 trial is therefore to test the safety, tolerability, and pharmacology of Darifenacin in patients with ALS. Specifically, 60 eligible subjects between 18 and 85 years of age will take 7.5 mg of darifenacin or placebo daily (by mouth) for two weeks followed by an increased dose of 15 mg for the next 22 weeks. The trial will evaluate the effects of this medication on several outcome measures including patient safety, physical and neurological function, muscle strength, depression levels, and NMJ innervation of patients with ALS. Detailed clinical assessments will be conducted at regular intervals throughout the study in order to achieve these objectives.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["Amyotrophic lateral sclerosis","Darifenacin","Neuromuscular junction"],"interventions":[{"type":"DRUG","name":"Darifenacin 7.5 MG Extended Release Oral Tablet"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2024-11-08","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Able to comprehend and willing to sign an Informed Consent Form (ICF).\n2. Male or female, ≥ 18 years old and ≤85 years old, at the time of signing the ICF.\n3. Confirmed diagnosis of familial or sporadic ALS, defined as meeting the probable, laboratory-supported probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology Modified El Escorial criteria (1).\n4. ALS duration of less than 36 months from the symptom onset.\n5. FVC of ≥ 50 %.\n6. Able to swallow tablets without crushing.\n7. A female patient is eligible to participate if she is not breastfeeding, has negative pregnancy test at screening, has no intention of becoming pregnant during the course of the study, and agrees to use appropriate contraceptive drugs or devices (as defined in section 3.4 of the study protocol) for the duration of the study.\n8. If male and has a partner who may become pregnant, agrees to ensure that he and/or his partner use a reliable form of birth control (as defined in section 3.4 of the study protocol) for the duration of the study and refrain from donating sperm during this period.\n9. Participants receiving standard care for ALS prior to entering the trial (i.e. Riluzole, Edaravone, and Albrioza), must be on a stable dosing regimen prior to the randomization and agree to remain on this dosage during the study period:\n\n   * In the case of taking Riluzole, the patient must have been on a stable dose at least 30 days prior to start date.\n   * In the case of taking Edaravone, the patient must have been on a stable dose at least 30 days prior to start date.\n   * In the case of receiving Albrioza, the patient must have been on a stable dose at least 30 days prior to start date.\n10. For participants who consent to the optional biopsy:\n\n    * Participants with normal platelet or coagulation test values.\n    * Participants who are receiving anticoagulant medications will need to abstain from using anticoagulants for a specific number of days before and after the biopsy, as decided by the study doctor on a case-by-case basis.\n\nExclusion Criteria:\n\n1. Patients with, or at risk for, the following conditions:\n\n   * Untreated or uncontrolled narrow-angle glaucoma;\n   * Gastric retention\n   * Urinary retention\n   * Liver disease\n2. Patients with a known history of severe allergic or anaphylactic reactions to antimuscarinic medications\n3. If diagnosed with another neurodegenerative disease (e.g. Multiple Sclerosis, Parkinson, Myasthenia Gravis, and Alzheimer's disease).\n4. Subjects with severe hepatic impairment or abnormal liver enzymes, as defined as Child-Pugh B and C scores.\n5. Subject has a history of, or positive test result at Screening, for hepatitis C virus antibody.\n6. Subjects with acute or prolonged hepatitis B \\& C.\n7. Any medical condition that might interfere with the patient's participation in the trial, poses any added risk for the patient, or confounds the assessment of the patient according to the Investigator's judgement.\n8. Subjects with any uncontrolled (unresolved) medical condition other than ALS, as determined by the Investigator.\n9. Subjects who are currently enrolled in another clinical trial and receiving an Investigational Product (IP) (including but not limited to stem cell therapy or gene therapy).\n10. Treatment with an investigational drug within 1 month or within a time period equal to 5 half-lives (if known) whichever is longer, of starting study treatment.\n11. Patients with prior darifenacin treatment.\n12. History of drug and/or alcohol abuse (according to Diagnostic and Statistical Manual of Mental Disorders) prior to the screening as determined by the Investigator.\n13. If female, subjects who are pregnant, breastfeeding, or intending to conceive during the course of the study.\n14. Subjects with an abnormal electrocardiogram (ECG) at screening (any abnormality that the PI believes that entering the study place the participant at risk).\n15. Subjects who are receiving strong CYP3A4 inducers such as carbamazepine (anticonvulsant), phenytoin (anticonvulsant), rifampin (antibiotic), and modafinil (wakefulness-promoting agent).\n16. Subjects who are receiving potent CYP3A4 inhibitors such as clarithromycin (macrolide antibiotic), ketoconazole and itraconazole (antifungal medications), nefazadone (antidepressant), nelfinavir and ritonavir (protease inhibitors).\n17. Subjects who are receiving or received within 30 days prior to the starting of the trial CYP2D6 substrates with a narrow therapeutic window such as include flecainide (Class IC anti-arrhythmic), thioridazine (antipsychotic) and tricyclic antidepressants.\n18. Subjects who are receiving or received intramuscular botulinum injections in the arms, legs, or face in the past 6 months.\n19. Subjects who are receiving or received within 30 days prior to the starting of the trial antimuscarinic medications for the treatment of overactive bladder such as fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium.\n20. Only for patients that consented to the Optional Needle Muscle Biopsy procedures.\n21. Subject is taking an anticoagulant (with the exception of aspirin at the investigator's discretion) or is at risk of increased or uncontrolled muscle biopsy-related bleeding.\n22. Subjects with bleeding risk factors which include, but are not limited to, anatomical factors at or near the muscle biopsy site (e.g., vascular abnormalities, neoplasms, or other abnormalities) or abnormal platelet or coagulation test values at visit 1.","locations":[{"facility":"Ottawa Hospital Research Institute","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Neurological Institute","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nisha Pulimood, PhD","phone":"514-396-2401","email":"nisha.pulimood@mcgill.ca"},{"name":"Gabriele Riva, PhD","phone":"","email":"gabriele.riva@mcgill.ca"}],"primaryOutcomes":["Safety and tolerability of oral doses of 15 mg darifenacin"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["ottawa-canada","montreal-canada"],"enrichment":{"headline":"Phase 2: testing Darifenacin 7.5 MG Extended Release Oral Tablet for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Amyotrophic lateral sclerosis (ALS) is a progressive neurological disorder characterized by selective death of upper and lower motor neurons, which leads to severe disability and fatal outcomes. One of the major hallmarks of ALS is the denervation of neuromuscular junctions (NMJs), which is one of the earliest events seen in ALS patients and mouse models of ALS.","whoItsFor":["Ages 18 Years to 85 Years","Male or female, ≥ 18 years old and ≤85 years old, at the time of signing the ICF","Confirmed diagnosis of familial or sporadic ALS, defined as meeting the probable, laboratory-supported probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology Modified El Escorial criteria (1)","ALS duration of less than 36 months from the symptom onset","Able to swallow tablets without crushing","If male and has a partner who may become pregnant, agrees to ensure that he and/or his partner use a reliable form of birth control (as defined in section 3.4 of the study protocol) for the duration of the study and refrain from donating sperm during this period","Participants receiving standard care for ALS prior to entering the trial (i.e. Riluzole, Edaravone, and Albrioza), must be on a stable dosing regimen prior to the randomization and agree to remain on this dosage during the study period:","In the case of taking Riluzole, the patient must have been on a stable dose at least 30 days prior to start date"],"whoShouldSkip":["Patients with, or at risk for, the following conditions:","Untreated or uncontrolled narrow-angle glaucoma;","Patients with a known history of severe allergic or anaphylactic reactions to antimuscarinic medications","If diagnosed with another neurodegenerative disease (e.g. Multiple Sclerosis, Parkinson, Myasthenia Gravis, and Alzheimer's disease)","Subjects with severe hepatic impairment or abnormal liver enzymes, as defined as Child-Pugh B and C scores","Subject has a history of, or positive test result at Screening, for hepatitis C virus antibody","Subjects with acute or prolonged hepatitis B \\& C"],"whatHappens":"If you join, the listed intervention(s) are Darifenacin 7.5 MG Extended Release Oral Tablet, or Placebo. The registry lists allocation as randomized. Amyotrophic lateral sclerosis (ALS) is a progressive neurological disorder characterized by selective death of upper and lower motor neurons, which leads to severe disability and fatal outcomes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.609Z"},{"nctId":"NCT06249932","title":"Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease","officialTitle":"The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Reduced Ejection Fraction - a Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Taiwan University Hospital","sponsorClass":"OTHER","summary":"In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.","conditions":["Heart Failure With Reduced Ejection Fraction","End Stage Renal Disease on Dialysis"],"keywords":["end stage renal disease","sodium-glucose co-transporter 2 inhibitors,","heart failure with reduced ejection fraction","empagliflozin","left ventricular mass"],"interventions":[{"type":"DRUG","name":"Empagliflozin 25 MG"},{"type":"DRUG","name":"Placebo"}],"enrollment":95,"startDate":"2024-03-13","completionDate":"2027-12-31","sex":"ALL","minAge":"20 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥20 years old\n* ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months\n* Documented left ventricular ejection fraction \\<50% by any imaging modality within 1 month of screening\n\nExclusion Criteria:\n\n* Age \\<20 years old\n* Ongoing pregnancy\n* NYHA class IV heart failure\n* Any hospitalization for heart failure within the past month\n* Ongoing acute urinary tract infection at the time of screening\n* Known acute genital infection\n* Severe peripheral artery disease (Rutherford category 4-6)\n* Acute coronary syndrome, stroke or transient ischemic attack within the past month\n* Recent initiation of chronic maintenance hemodialysis within 6 months\n* Adjustment of dry weight with changes greater than 5% of body weight within the past month\n* Documented left ventricular ejection fraction ≥50% by any imaging modality within 1 month of screening\n* Refused informed consent","locations":[{"facility":"National Taiwan University Hospital Hsinchu Branch","city":"Hsinchu","state":"Taiwan","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shin Kong Wu Ho-Su Memorial Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Donna Shu-Han Lin, MD","phone":"+886912902379","email":"Donna.lin24@gmail.com"},{"name":"Hao-Yun Lo, MD","phone":"+886972234640","email":"limoonby@gmail.com"}],"primaryOutcomes":["Left ventricular mass"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":["empagliflozin"],"locationSlugs":["hsinchu-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 4: testing Empagliflozin 25 MG for Heart Failure With Reduced Ejection Fraction","inPlainEnglish":"In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their how well it works and safety in patients under chronic hemodialysis.","whoItsFor":["Ages 20 Years to any","ESRD under chronic, maintenance hemodialysis with stable dry weight for the past 6 months","Documented left ventricular ejection fraction \\<50% by any imaging modality within 1 month of screening"],"whoShouldSkip":["NYHA class IV heart failure","Any hospitalization for heart failure within the past month","Ongoing acute urinary tract infection at the time of screening","Known acute genital infection","Severe peripheral artery disease (Rutherford category 4-6)","Acute coronary syndrome, stroke or transient ischemic attack within the past month","Recent initiation of chronic maintenance hemodialysis within 6 months"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 25 MG, or Placebo. The registry lists allocation as randomized. In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 95 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.614Z"},{"nctId":"NCT06252584","title":"Multi-peptide Vaccination Adjuvanted With XS15 in Acute Myeloid Leukemia Patients","officialTitle":"Multi-peptide Vaccination Adjuvanted With the TLR1/2 Ligand XS15 in Acute Myeloid Leukemia (AML) Patients Who Have Achieved Complete Remission With First Line Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital Tuebingen","sponsorClass":"OTHER","summary":"The aim of this Phase I study is to evaluate the immunogenicity along with safety and toxicity as well as first efficacy of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.","conditions":["Acute Myeloid Leukemia, Adult"],"keywords":["acute myeloid leukemia"],"interventions":[{"type":"DRUG","name":"Vaccines, Peptide"}],"enrollment":20,"startDate":"2024-06-10","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Males or females aged ≥18 years of age\n* Existence of a written informed consent\n* Documented diagnosis of AML according to WHO guidelines\n\n  * morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)\n  * positive MRD is permitted\n  * completion of previous intensive therapy (first vaccination 4-28 weeks after last application of chemotherapy) or\n  * ongoing low intensity treatment with e.g. hypomethylating agents (HMA), venetoclax, etc.\n  * ongoing maintenance treatment with e.g. oral azacytidine or midostaurin is permitted.\n  * not eligible for allogeneic stem cell transplantation\n* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2\n* Adequate organ function laboratory values.\n\n  * bilirubin ≤ 3 times upper limit range (exception isolated indirect hyperbilirubinemia (Morbus Gilbert-Meulengracht)).\n  * alanine aminotransferase (ALT) and aminotransferase (AST), ≤ 5 times upper limit range\n  * creatinine clearance GFR \\> 30 ml/min (CKD-EPI)\n  * platelets \\> 50.000/μl\n  * absolute CD3+ T cell count ≥ 200/μl\n* negative serological hepatitis B test or negative PCR in case of positive serological test without evidence of an active infection, negative testing of hepatitis C RNA, negative HIV test within 6 weeks prior to study inclusion\n* Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception (for more detailed information see chapter 5.7 Contraception, pregnancy, sperm donation and nursing). This should be started from the signing of the informed consent and be continued until 3 months (both female and male patients) after last vaccination).\n* For FCBP two negative pregnancy tests (sensitivity of at least 25 mlU/mL) prior to first application of first vaccination, one at screening and the other prior (\\< 24 h) to first vaccination\n* Postmenopausal or evidence of non-child-bearing status\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Unwilling or unable to follow the study schedule for any reason.\n* Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted).\n* Concurrent or previous treatment within 28 days in another interventional clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints.\n* Major surgery within 28 days of dosing of study drug.\n* Treatment with immunotherapy agents within 28 days of dosing of study drug.\n* Diagnosis of acute promyelocytic leukemia (APL)\n* Autoimmune disease that requires or has required treatment with systemic immunosuppressive treatments, except low dose corticosteroids (\\< 10 mg/ day), in the past 1 year.\n* Prior history of malignancies, other than AML/myelodysplastic syndrome (MDS), unless the subject has been free of the disease for\n\n  ≥ 2 years. Exceptions include the following: basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, histological finding of prostate cancer of TNM stage T1\n* Prior stem cell allograft or organ transplantation\n* Ongoing or active infection (including SARS-CoV-2)\n* Have received any live vaccination within 28 days prior to the first dose of AML-VAC-XS15.","locations":[{"facility":"University Hospital Tuebingen","city":"Tübingen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juliane Walz, Prof. Dr.","phone":"+49 7071 29","email":"kketi@med.uni-tuebingen.de"},{"name":"Helmut Salih, Prof.Dr.","phone":"+49 7071 29","email":"kketi@med.uni-tuebingen.de"}],"primaryOutcomes":["immunogenicity"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["t-bingen-germany"],"enrichment":{"headline":"Phase 1: testing Vaccines, Peptide for Acute Myeloid Leukemia, Adult","inPlainEnglish":"The aim of this Phase I study is to measure the immunogenicity along with safety and toxicity as well as first how well it works of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.","whoItsFor":["Ages 18 Years to any","Males or females aged ≥18 years of age","Documented diagnosis of AML according to WHO guidelines","morphological complete remission (CR) or complete remission with incomplete blood count recovery (CRi)","positive MRD is permitted","completion of previous intensive therapy (first vaccination 4-28 weeks after last application of chemotherapy) or","ongoing low intensity treatment with e.g. hypomethylating agents (HMA), venetoclax, etc","ongoing maintenance treatment with e.g. oral azacytidine or midostaurin is permitted"],"whoShouldSkip":["Pregnant or breastfeeding","Unwilling or unable to follow the study schedule for any reason","Chemotherapy or other systemic therapy or radiotherapy, up to 14 days prior to the first dose of study drug (ongoing maintenance treatment or low intensity treatment is permitted)","Concurrent or previous treatment within 28 days in another treatment clinical trial with an investigational anticancer therapy or any other investigational therapy, which would interfere with the study's primary and secondary endpoints","Major surgery within 28 days of dosing of study drug","Treatment with immunotherapy agents within 28 days of dosing of study drug","Diagnosis of acute promyelocytic leukemia (APL)"],"whatHappens":"If you join, the listed intervention(s) are Vaccines, Peptide. The registry lists allocation as na. The aim of this Phase I study is to measure the immunogenicity along with safety and toxicity as well as first how well it works of a multi-peptide vaccine adjuvanted with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG (AML-VAC-XS15) in AML patients who have achieved CR or CRi with first line treatment.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Tübingen. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.834Z"},{"nctId":"NCT06252649","title":"Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","officialTitle":"Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Amgen","sponsorClass":"INDUSTRY","summary":"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.","conditions":["Metastatic Colorectal Cancer"],"keywords":["Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology"],"interventions":[{"type":"DRUG","name":"FOLFIRI Regimen"},{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Panitumumab"},{"type":"DRUG","name":"Bevacizumab-awwb"}],"enrollment":450,"startDate":"2024-07-17","completionDate":"2028-09-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan","locations":[{"facility":"Ironwood Cancer and Research Centers Scottsdale","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Jude Medical Center","city":"Fullerton","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"City of Hope National Medical Center","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer and Blood Research Center, LLC","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Norwalk Hospital","city":"Norwalk","state":"Connecticut","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Cancer Specialists of North Florida - Southpoint","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"D and H Cancer Research Center","city":"Margate","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Mid Florida Hematology and Oncology Centers PA","city":"Orange City","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Boca Raton Clinical Research Medical Center Inc","city":"Plantation","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Georgia Cancer Specialists","city":"Atlanta","state":"Georgia","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Insight Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope and Healing Cancer Services","city":"Hinsdale","state":"Illinois","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Orchard Healthcare Research Inc","city":"Skokie","state":"Illinois","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Pikeville Medical Center","city":"Pikeville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health System","city":"Detroit","state":"Michigan","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Cancer and Hematology Centers of Western Michigan","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Louis Cancer Care West County","city":"Bridgeton","state":"Missouri","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Minniti Center for Medical Oncology and Hematology","city":"Mickleton","state":"New Jersey","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Duke Cancer Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FirstHealth Cancer Center","city":"Pinehurst","state":"North Carolina","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Carolina Blood and Cancer Care","city":"Rock Hill","state":"South Carolina","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Tennessee Oncology PLLC - Chattanooga","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology, PLLC","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundacion Favaloro","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Argentino de Diagnóstico y Tratamiento","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigaciones Clinicas Moleculares - Centro de Endocrinologia y Diabetes Dr Raul Gutman SRL","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cemic","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"TERMINATED","lat":null,"lon":null},{"facility":"Sanatorio Británico de Rosario","city":"La Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones clinicas de Mar del Plata","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Córdoba","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Allende","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"TERMINATED","lat":null,"lon":null},{"facility":"Clinica Universitaria Privada Reina Fabiola","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Viedma","city":"Viedma","state":"Río Negro Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Exelsus Oncologia Clinica","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Britanico de Buenos Aires","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Oncologico Riojano Integral","city":"La Rioja","state":"","country":"Argentina","status":"TERMINATED","lat":null,"lon":null},{"facility":"Chris OBrien Lifehouse","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toowoomba Hospital","city":"Toowoomba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flinders Medical Centre","city":"Bedford Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Queen Elizabeth Hospital","city":"Woodville South","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Health, Austin Hospital","city":"Heidelberg","state":"Victoria","country":"Australia","status":"TERMINATED","lat":null,"lon":null},{"facility":"Medizinische Universitaet Graz","city":"Graz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ordensklinikum Linz Barmherzige Schwestern","city":"Linz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Landeskrankenhaus Feldkirch","city":"Rankweil","state":"","country":"Austria","status":"TERMINATED","lat":null,"lon":null},{"facility":"Universitaetsklinikum Allgemeines Krankenhaus Wien","city":"Vienna","state":"","country":"Austria","status":"TERMINATED","lat":null,"lon":null},{"facility":"Krankenhaus Wiener Neustadt","city":"Wiener 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listed intervention(s) are FOLFIRI Regimen, Sotorasib, or Panitumumab. The registry lists allocation as randomized. The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 450 people at 291 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.970Z"},{"nctId":"NCT06252753","title":"Observational Study Protocol: LIVER-R","officialTitle":"An Observational Multi-Center Study to Evaluate Real-World Treatment Outcomes With or Without Durvalumab-Based Regimens in Hepatobiliary Cancers","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"Given the number of anticipated durvalumab-based treatment launches in the hepatobiliary cancer space over the next 3 years, there is a need to capture contemporary real-world data across these indications. LIVER-R is a multi-country, multi-center, observational study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP). The study design will include primary and secondary data collection. The primary objective of this study is to evaluate the effectiveness of regimens (durvalumab-based or otherwise) in real-world settings as measured by real-world overall survival. Other endpoints include demographics, clinical characteristics, clinically significant events of interest, treatment patterns, concomitant medications, treatment provider characteristics, and other real-world clinical endpoints (such as duration of treatment, progression-free survival, time to treatment progression, time to next treatment, time to treatment discontinuation, recurrence-free survival, and time to treatment recurrence ).","conditions":["Hepatobiliary Cancers"],"keywords":["Hepatobiliary cancer","Unresectable hepatocellular carcinoma (uHCC)","embolization eligible uHCC (eeHCC)","Advanced biliary tract cancer (aBTC)","Durvalumab","Observatory","Real-world"],"interventions":[{"type":"OTHER","name":"Durvalumab-based combination therapies in observational study setting"},{"type":"OTHER","name":"Durvalumab-based combination therapies in observational study setting"},{"type":"OTHER","name":"Non Durvalumab-based therapies in observational study setting"},{"type":"OTHER","name":"Durvalumab-based combination therapies in observational study settings"}],"enrollment":4000,"startDate":"2023-12-20","completionDate":"2030-12-30","sex":"ALL","minAge":"18 Years","maxAge":"130 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria General Inclusion Criteria\n\nAll patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:\n\n1. Age ≥18 years and a lawful adult in the country at the index date\n2. Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)\n3. Decision to treat was made independently and prior to obtaining informed consent\n4. Informed consent was obtained as per country level regulations (includes waiver of consent for retrospective data collection if approved)\n\naBTC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the aBTC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. Patient has unresectable aBTC\n2. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)\n\nuHCC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the uHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. Patient has unresectable uHCC\n2. Not eligible for LRT, as well as for those who progressed following LRT\n3. Has received or is intending to receive a durvalumab-based regimen (may have been treated in an EAP)\n\neeHCC Specific Inclusion Criteria\n\nA patient will be eligible to be included in the eeHCC cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. HCC confirmed by radiological or histological diagnosis\n2. Child-Pugh A-B7\n3. Disease not amenable to curative treatment but amenable to LRT at index\n4. Patients with liver-confined HCC who initiated first non-curative intent LRT on or after 01 January 2024\n5. Patients eligible for LRT with palliative intent such as TACE/ TARE/transarterial infusion chemotherapy (TAIC)/ hepatic arterial infusion chemotherapy (HAIC)/transarterial embolization (TAE) given by itself or in combination with other systemic therapy (can include durvalumab) within 60 days of the LRT\n\nEMERALD Specific Inclusion Criteria\n\nA patient will be eligible to be included in the EMERALD cohort if they meet all general inclusion criteria 1-4 in addition to the following criteria:\n\n1. HCC confirmed by radiological or histological diagnosis\n2. Child-Pugh score of A-B7\n3. Liver-confined disease not amenable to curative treatment but amenable to LRT at index\n4. Receipt of a durvalumab-based regimen in combination with LRT administered within 28 days of each other (index is the first of the two treatments administered)\n\nExclusion Criteria\n\nGeneral Exclusion Criteria\n\nA patient will be excluded from participating in this study if they meet any of the following general criteria 1-2 or any cohort specific exclusion criteria:\n\n1. Currently/was participating or plans to participate in any clinical trial for investigational treatment for hepatobiliary cancers on or after the diagnosis date until the index date\n2. Second primary malignancy prior to HCC or BTC diagnosis\n\naBTC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the aBTC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Received a liver transplant during the baseline period\n2. Received more than 1 cycle of Gemcitabine + Cisplatin for biliary tract cancer on or after diagnosis of unresectable, locally advanced or metastatic disease through the index date. Patients who received any systemic therapy while having early stage, resectable disease are eligible\n\nuHCC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the uHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Received a liver transplant during the baseline period\n2. Received other systemic therapies for hepatobiliary cancer indication on or after diagnosis date through the index date\n\neeHCC Specific Exclusion Criteria\n\nA patient will be excluded from participating in the eeHCC cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Eligible for curative therapy at the time of receiving LRT (ablation)\n2. Extrahepatic spread\n3. Portal vein tumor thrombosis (PVTT) of VP3/4\n4. Receipt of systemic therapy prior to index LRT in the baseline period\n5. Liver transplant any time prior to index\n\nEMERALD Specific Exclusion Criteria\n\nA patient will be excluded from participating in the EMERALD cohort if they meet any of the general exclusion criteria 1-2 or any of the following criteria:\n\n1. Eligible for curative therapy at the time of receiving LRT (ablation)\n2. Extrahepatic spread\n3. Portal vein tumor thrombosis (PVTT) of VP3/4\n4. Receipt of systemic therapy prior to index LRT in the baseline period\n5. 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LIVER-R is a multi-country, multi-center, watch-and-measure (no experimental treatment required) study of patients with a confirmed diagnosis of hepatobiliary cancer treated with or without a durvalumab-based regimen as part of routine clinical practice or early access program (EAP).","whoItsFor":["Ages 18 Years to 130 Years","General who can join","All patients must meet all of the following general criteria 1-4 along with all respective cohort specific criteria noted below:","Age ≥18 years and a lawful adult in the country at the index date","Confirmed presence of malignancy of primary hepatobiliary cancer by any method (e.g., radiological, histological, etc.)","aBTC Specific who can join","A patient will be eligible to be included in the aBTC cohort if they meet all general who can join 1-4 in addition to the following criteria:","Patient has unresectable aBTC"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 4,000 people at 146 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.631Z"},{"nctId":"NCT06253494","title":"Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer","officialTitle":"Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nEndometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC often has increased levels of a protein called HER2. Cancers with HER2 tend to be more aggressive and have poorer outcomes.\n\nObjective:\n\nTo test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plus a drug that supercharges immune cells that kill tumor cells (N-803)-combined with 2 FDA-approved cancer treatment drugs in people with EC.\n\nEligibility:\n\nAdults aged 18 and older with HER2-positive EC that returned or got worse after treatment.\n\nDesign:\n\nAdHER2DC vaccine is made from each participant s own blood. Participants will undergo apheresis: Blood is removed from the body through a tube attached to a needle. The blood passes through a machine that separates out the target cells. The remaining blood is returned to the body through a second needle. A special catheter may be needed.\n\nThe first treatment cycle is 28 days; each cycle after that will be 21 days.\n\nAll participants will get the 2 approved drugs and the vaccine. One drug is a tablet taken by mouth once a day, every day. The other drug is given through a tube attached to a needle inserted into a vein.\n\nThe vaccine is injected under the skin. Participants will receive the vaccine on day 1 of cycles 1, 2, and 3. Additional doses up to 3 doses will be give if possible.\n\nSome participants will receive N-803. This drug is injected under the skin of the abdomen on day 1 of each cycle.\n\nTreatment may last up to 1 year. Follow-up visits will continue up to 2 more years.","conditions":["Endometrial Cancer","Cancer of Endometrium","Carcinoma of Endometrium","Endometrial Carcinoma"],"keywords":["Cancer Vaccine","Combination of anti-cancer drugs","Immunotherapy","HER2 Positive Cancer"],"interventions":[{"type":"BIOLOGICAL","name":"AdHER2DC vaccine"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"BIOLOGICAL","name":"N-803"},{"type":"DRUG","name":"Lenvatinib"},{"type":"DEVICE","name":"PATHWAY HER2 (4B5) assay"}],"enrollment":60,"startDate":"2024-05-14","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Histologically confirmed endometrial cancer.\n* Radiographically confirmed metastatic or locally advanced disease.\n* Evaluable (measurable or non-measurable) disease, per RECIST 1.1.\n* HER2 IHC 1+, 2+ or 3+ tumor confirmed by PATHWAY HER2 (4B5) test. NOTE: The HER2 status in participants who had prior anti-HER2 therapy should be confirmed in the tumor tissue obtained after completing the anti-HER2 therapy.\n* Participants must have received and progressed after at least one (1) line of systemic therapy for endometrial cancer.\n* Age \\>=18 years.\n* ECOG performance status \\<=2.\n* Participants must have available tumor tissue or be willing to undergo a mandatory research biopsy. NOTE: Samples must be collected after HER2 directed therapy if the participant had anti-HER2 therapy.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\> 1,000/microliter\n  * Platelets \\> 100,000/microliter\n  * Hemoglobin (Hgb) \\> 9 g/dL (any number of transfusions within 60 days before apheresis is allowed)\n  * Total bilirubin \\<=1.5 X upper limit of normal (ULN). NOTE: In participants with Gilbert s Syndrome or known liver metastasis, total bilirubin \\<=3.0 X ULN is allowed\n  * Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT) \\<=3.0 X ULN. NOTE: AST/ALT \\<=5.0 X ULN is allowed in participants with known liver metastasis\n  * An estimated creatinine clearance (CrCl) \\<=1.5 X ULN OR \\>30 mL/min/1.73 m2 for participants with creatinine levels \\>1.5 X ULN (calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n  * Dip stick urine protein \\< 3 or urine protein \\< 1 gram (g)/24 hour if dip stick urine is \\>= 3+\n* Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable. Hepatitis C virus (HCV)-infected participants can be enrolled if HCV RNA level is undetectable.\n* Participants with previously treated non-active brain metastases or central nervous system metastases more than 28 days from definitive radiotherapy or surgery are eligible.\n* Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device (IUD), tube ligation, a partner has had the previous vasectomy, abstinence) at the time of study entry, for the duration of study treatment, and up to 6 months after the last dose of the study drug(s).\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Participants must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n* Administration of any standard of care or investigational checkpoint inhibitors (e.g., anti-CTLA, anti-PD-1, anti-PD-L1, anti-TIGIT, anti-TIM3, or anti-LAG3 antibodies or small molecules) within 6 months prior to apheresis.\n* History of grade 3 or 4 immune related adverse events from the use of immune checkpoint inhibitors.\n* History of Lenvatinib use\n* History of severe immediate hypersensitivity reaction to compounds similar to study drugs or their components (e.g., monoclonal antibody preparations).\n* Surgery to abdomen/pelvis/chest within 3 months prior to apheresis.\n* Other malignancies diagnosed within 24 months prior to apheresis. NOTE: Participants who completed treatment for in-situ carcinomas (e.g., breast, cervix, bladder), or basal or squamous cell carcinoma of the skin are eligible if no ongoing treatment is needed per Standard of Care.\n* Arterial or venous thromboembolism within 6 months prior to apheresis.\n* History of cerebrovascular accident or stroke (transient ischemic attack, hemorrhagic or ischemic) within 6 months prior to apheresis.\n* Functional or objective cardiac dysfunction: New York Heart Association (NYHA) Functional Capacity III or IV or Objective Assessment C or D.\n* Fridericia's corrected QT interval (QTcF) \\>= 480 msec or evidence of third-degree AV block on screening electrocardiogram (ECG).\n* Ejection fraction by screening echocardiogram \\< 50 percent.\n* Participants requiring therapeutic anticoagulation regimen(s) (e.g., warfarin, rivaroxaban, apixaban, dabigatran, edoxaban, low molecular weight heparin \\[e.g., enoxaparin, dalteparin, tinzaparin\\], heparin, fondaparinux).\n* History of gastrointestinal or non-gastrointestinal fistula \\>= Grade 3 (CTCAE v.5.0).\n* Radiographic evidence of major blood vessel invasion/infiltration.\n* History of hemoptysis or tumor bleeding within 1 month prior to apheresis.\n* Current gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n* Any form of primary immunodeficiency.\n* Participants with active autoimmune disease or a history of autoimmune disease, which require immune suppressive treatment such as systemic corticosteroids or other systemic immune suppressants (e.g., methotrexate, cyclosporine, and biologics). NOTE: Participants with vitiligo, endocrine deficiencies on replacement dose are eligible.\n* Systemic corticosteroid therapy of higher than a physiologic dose (the equivalent of prednisone 10 mg/day) within 14 days prior to apheresis. NOTE: Any topical steroid medications (e.g., corticosteroid creams, ointments, and eye drops) are allowed.\n* Solid organ or allogeneic hematopoietic stem cell transplant recipients.\n* Human immunodeficiency virus (HIV)-positive participants.\n* Pregnancy (confirmed with beta-Human chorionic gonadotropin (HCG) serum or urine pregnancy test performed in IOCBP at screening).\n* Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Megan P Hausler, R.N.","phone":"(240) 858-3544","email":"megan.hausler@nih.gov"},{"name":"Hoyoung M Maeng, M.D.","phone":"(240) 781-3253","email":"hoyoung.maeng@nih.gov"}],"primaryOutcomes":["Phase I: Estimate recommended RP2D of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer","Phase II: Preliminarily assess the efficacy of a combination of pembrolizumab, lenvatinib, N-803, and AdHER2DC vaccine in participants with HER2 positive endometrial cancer"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing AdHER2DC vaccine for Endometrial Cancer","inPlainEnglish":"Background: Endometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC often has increased levels of a protein called HER2.","whoItsFor":["Ages 18 Years to 120 Years","Histologically confirmed endometrial cancer","Radiographically confirmed metastatic or locally advanced disease","Evaluable (measurable or non-measurable) disease, per RECIST 1.1","HER2 IHC 1+, 2+ or 3+ tumor confirmed by PATHWAY HER2 (4B5) test. NOTE: The HER2 status in participants who had prior anti-HER2 therapy should be confirmed in the tumor tissue obtained after completing the anti-HER2 therapy","Participants must have received and progressed after at least one (1) line of systemic therapy for endometrial cancer","how well you can do daily activities (ECOG score) \\<=2","Participants must have available tumor tissue or be willing to undergo a mandatory research biopsy. NOTE: Samples must be collected after HER2 directed therapy if the participant had anti-HER2 therapy"],"whoShouldSkip":["Administration of any standard of care or investigational checkpoint inhibitors (e.g., anti-CTLA, anti-PD-1, anti-PD-L1, anti-TIGIT, anti-TIM3, or anti-LAG3 antibodies or small molecules) within 6 months prior to apheresis","History of grade 3 or 4 immune related side effects from the use of immune checkpoint inhibitors","History of Lenvatinib use","History of severe immediate hypersensitivity reaction to compounds similar to study drugs or their components (e.g., monoclonal antibody preparations)","Surgery to abdomen/pelvis/chest within 3 months prior to apheresis","Arterial or venous thromboembolism within 6 months prior to apheresis","History of cerebrovascular accident or stroke (transient ischemic attack, hemorrhagic or ischemic) within 6 months prior to apheresis"],"whatHappens":"If you join, the listed intervention(s) are AdHER2DC vaccine, Pembrolizumab, or N-803. The registry lists allocation as randomized. Background: Endometrial cancer (EC) of the uterus is becoming more common in the US.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.695Z"},{"nctId":"NCT06256575","title":"Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis","officialTitle":"Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Primus Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.","conditions":["Scleroderma, Systemic","Digital Ulcer"],"keywords":["SSc","Digital Ulcers","Sclerosis","Scleroderma"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Diosmin"},{"type":"OTHER","name":"Placebo"}],"enrollment":45,"startDate":"2025-05-02","completionDate":"2027-07-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (scleroderma)\n* At least one \"active\" digital ulcer\n* Medication for systemic sclerosis unchanged for 30 days\n\nExclusion Criteria:\n\n* Infection or gangrene in ulcer\n* Citrus allergy\n* Unstable heart, kidney, or liver disease\n* Active infection of any type\n* Current cancer treatment or uncured cancer\n* Pregnancy or breast feeding","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dalhousie University","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Joseph Health Care Centre","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Health System","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lukban","phone":"(480) 483-1410","email":"jlukban@primusrx.com"},{"name":"Mary L Sanstead","phone":"480-250-6689","email":"msanstead@primusrx.com"}],"primaryOutcomes":["Efficacy - Number (%) of healed baseline ulcers"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["calgary-canada","halifax-canada","london-canada","ottawa-canada","toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: Diosmin for Scleroderma, Systemic","inPlainEnglish":"This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product.","whoItsFor":["Ages 18 Years to any","Diagnosis of systemic sclerosis (scleroderma)","At least one \"active\" digital ulcer","Medication for systemic sclerosis unchanged for 30 days"],"whoShouldSkip":["Infection or gangrene in ulcer","Unstable heart, kidney, or liver disease","Active infection of any type","Current cancer treatment or uncured cancer","Pregnancy or breast feeding"],"whatHappens":"If you join, the listed intervention(s) are Diosmin, or Placebo. The registry lists allocation as randomized. This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.967Z"},{"nctId":"NCT06260033","title":"Stereotactic Body Radiation Therapy and FES PET/CT Imaging for the Treatment of Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer","officialTitle":"A Phase II Trial of Stereotactic Body Radiation Therapy and Fluoroestradiol Positron Emission Tomography in Patients With Oligoprogressive Estrogen Receptor Positive Metastatic Breast Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses (fractions) given over several days. This type of radiation therapy helps spare normal tissue and has been shown to improve survival. SBRT may kill more tumor cells and allow patients with oligoprogressive ER + metastatic breast cancer to continue taking current systemic treatment.\n\nThis trial also tests how well ER targeted positron emission tomography (PET)/ computed tomography (CT) imaging, using FES, works in identifying progressive disease in patients with ER + metastatic breast cancer. FES, a radiolabeled substance, binds to estrogen receptors and gives off radiation that can be detected by a PET scan. The PET scan, an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, FES, forms an image that shows where tumor cells with estrogen receptors can be found in the body. CT images use x-rays to provide an exact outline of organs. FES PET/CT may improve identification of progressive disease in patients with ER + metastatic breast cancer.","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Estrogen Receptor-Positive Breast Carcinoma","Metastatic Breast Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Scan"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"F-18 16 Alpha-Fluoroestradiol"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy"}],"enrollment":18,"startDate":"2024-07-23","completionDate":"2027-10-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n* Age: ≥ 18 years\n* Female or male\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Ability to read and understand English or Spanish for questionnaires\n* Histologically confirmed ER+ (any progesterone receptor \\[PR\\] and human epidermal growth factor receptor 2 \\[HER2\\] status is allowed) metastatic breast cancer\n* The presence of metastatic breast cancer at the time of study entry with progression in 1-4 lesions (including new lesions). Patients that have disease progression in the breast and/or ipsilateral axilla will be considered to have only 1 site of progression even if multiple nodules/lymph nodes are present. Patients with progression in \\> 4 lesions are not allowed. Patients with current progression of malignant pleural effusions, malignant ascites, abdominal carcinomatosis, and/or lymphangitic pulmonary involvement are considered to have \\> 4 metastases (Note that patients with a history of these conditions earlier in the disease course with no evidence of progression of these conditions are eligible.)\n* Evidence of extracranial disease progression in 1-4 discrete lesions will be defined by either of the following:\n\n  * Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0 criteria OR\n  * Progression of disease in at least 1 but up to 4 lesions as determined by the patient's treating oncologists such that the treating oncologist recommends changing to the next line systemic therapy. Note that a patient may not technically meet RECIST v 1.1 criteria for disease progression in this setting\n* SBRT must be feasible for all progressing lesions. Feasibility includes but is not limited to:\n\n  * All progressing lesions must have distinct borders AND\n  * Progressing lesions may not be located within 3 cm of previously irradiated critical structures such as the spinal cord, brachial plexus, brainstem, stomach, and/or small/large bowel that would render the metastasis unsafe to target with SBRT per the treating radiation oncologist\n* Patients with prior treated brain metastases that are stable are allowed. Patients must not have intracranial disease progression. Patients with prior or current leptomeningeal disease are not allowed\n* All progressing lesions must be amenable to stereotactic body radiation therapy to a dose of 30 Gy to 40 Gy in 3 to 5 fractions per the treating radiation oncologist\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease\n* Patients may not have received chemotherapy, radiation therapy, biological therapy, immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held during study therapy and can resume 7-14 days after completion of all study therapy (SBRT) at the discretion of treating physician. (Patients may continue anti-endocrine/hormone therapy before, during and after study therapy at the discretion of the treating medical oncologist.)\n* Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy\n* Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer. Prior malignancies not listed require principal investigator (PI) approval\n* Patients that have only liver metastases will not be allowed\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Proportion of patients that remain on their original systemic therapy for at least ≥ 24 weeks post stereotactic body radiation therapy (SBRT) treatment"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["duarte-california","irvine-california"],"enrichment":{"headline":"Phase 2: testing F-18 16 Alpha-Fluoroestradiol for Anatomic Stage IV Breast Cancer AJCC v8","inPlainEnglish":"This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression). Currently, the standard of care for breast cancer patients with oligoprogressive disease is to change systemic therapy when progression occurs.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) ≤ 2","Ability to read and understand English or Spanish for questionnaires","Histologically confirmed ER+ (any progesterone receptor \\[PR\\] and human epidermal growth factor receptor 2 \\[HER2\\] status is allowed) metastatic breast cancer","Evidence of extracranial disease progression in 1-4 discrete lesions will be defined by either of the following:","Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0 criteria OR","SBRT must be feasible for all progressing lesions. Feasibility includes but is not limited to:","All progressing lesions must have distinct borders AND"],"whoShouldSkip":["Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease","Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy","Patients that have only liver metastases will not be allowed","Females only: Pregnant or breastfeeding","Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures","Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Scan, or Computed Tomography. The registry lists allocation as na. This phase II trial tests how well stereotactic body radiation therapy (SBRT) works in treating patients with estrogen receptor positive (ER +) breast cancer that has spread from where it first started to other places in the body (metastatic) and has limited disease progression (oligoprogression).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 18 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.971Z"},{"nctId":"NCT06260943","title":"Targeted Navigation in Hepatocellular Carcinoma (HCC)","officialTitle":"Targeted Navigation to Achieve Health Equity: Increasing Access to Care, Patient Engagement and Research Participation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Miami","sponsorClass":"OTHER","summary":"The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.","conditions":["Hepatocellular Carcinoma","Cholangiocarcinoma","Hepatobiliary Cancer"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Target Navigation Pilot Program"}],"enrollment":210,"startDate":"2024-04-15","completionDate":"2026-10-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* HCC Patients:\n\n  * Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma.\n  * Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0.\n  * Adults, age 18 or older\n  * Able to provide informed consent\n* All other interviewees:\n\n  * Advocates who will self-identify as having had HCC.\n  * Others who self-identify as either a caregiver or support person of an HCC patient.\n\nPhysicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients.\n\nExclusion Criteria:\n\n* Unable to speak Spanish or English\n* West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment.\n* Adults unable or unwilling to consent\n* Individuals who are not yet adults (infants, children, teenagers)\n* Prisoners\n* Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected","locations":[{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gloria Figueroa","phone":"(305) 243-0779","email":"gef44@med.miami.edu"},{"name":"Patricia Jones, MD","phone":"(305) 243-0779","email":"pdjones@med.miami.edu"}],"primaryOutcomes":["Number of Hours for Each Contact","Number of Months of Total Navigation","Acceptability"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["miami-florida"],"enrichment":{"headline":"Not a traditional drug phase: Target Navigation Pilot Program for Hepatocellular Carcinoma","inPlainEnglish":"The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address.","whoItsFor":["Ages 18 Years to any","Enrolled or eligible for enrollment in Unified Prospective Registry and Biorepository of Patients with Chronic Liver Disease or Hepatobiliary Cancers Including Hepatocellular Carcinoma (HCC) and Cholangiocarcinoma","Diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and International Classification of Diseases, Tenth Revision (ICD-10) C22.0","Adults, age 18 or older","All other interviewees:","Advocates who will self-identify as having had HCC","Others who self-identify as either a caregiver or support person of an HCC patient","Physicians/Licensed Independent Practitioners, Social Workers, Nurse Navigators, and Research Coordinators will all self-identify as being involved in the care of HCC patients"],"whoShouldSkip":["West Haven Grade 2 or higher hepatic encephalopathy19 or other cognitive impairment","Adults unable or unwilling to consent","Individuals who are not yet adults (infants, children, teenagers)","Given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected"],"whatHappens":"If you join, the listed intervention(s) are Target Navigation Pilot Program. The registry lists allocation as na. The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 210 people at Miami. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.626Z"},{"nctId":"NCT06262178","title":"Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children","officialTitle":"Parenting STAIR: Adapting a Trauma-Focused Parenting Intervention for Military-Connected Mothers and Their Children","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"New York University","sponsorClass":"OTHER","summary":"The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.\n\nThe main questions the study aims to answer are: from pre-treatment to post-treatment 1) Does PSTAIR-M reduce maternal PTSD and/or depression symptoms?, and 2) Does PSTAIR-M improve parental functioning?\n\nParticipants will: 1) attend 12-16 weekly, 1-hour online treatment sessions with their assigned clinicians, 2) complete three 1-hour online assessments administered by research staff, 3) engage with their child in three 15-30-minute online, observed play sessions, 4) have assessments and observed play sessions audio and video recorded.\n\nParticipants may also be invited to participate in an optional, 30-minute online one-on-one qualitative interview, which would be audio and video recorded and would cover participants' experiences with the intervention, the clinic sites, and their providers.","conditions":["PTSD","Depression","Parent-Child Relations"],"keywords":["PTSD","Depression","STAIR","PC-CARE","Parenting","Parent-Child Relations","Military Family"],"interventions":[{"type":"BEHAVIORAL","name":"Parenting-STAIR Modular (PSTAIR-M)"}],"enrollment":120,"startDate":"2025-07-21","completionDate":"2027-05-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran;\n2. Has a child aged 2-10;\n3. Legal guardian of index child with legal and physical custody;\n4. Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));\n5. Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria \\[B, C, D, E\\] on the PCL-5), and/or depression (PHQ-9 score ≥8), and/or low parenting self-efficacy (PSOC score \\<59);\n6. Able to speak and understand English or Spanish;\n7. Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors.\n\nExclusion Criteria:\n\n1. High risk for suicide (Ask Suicide-Screening Questions (ASQ));\n2. Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);\n3. Disability affecting communication, such as deafness;\n4. Index child with severe developmental disability;\n5. Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF));\n6. Currently receiving another trauma-focused individual mental health treatment.","locations":[{"facility":"Steven A. Cohen Military Family Clinic at Endeavors, El Paso","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Steven A. Cohen Military Family Clinic at Endeavors, Killeen","city":"Killeen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Steven A. Cohen Military Family Clinic at Endeavors, San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathrine S Sullivan, PhD","phone":"3235526056","email":"ks5313@nyu.edu"},{"name":"Gina M Angelotti, MPH","phone":"6462671807","email":"ga2208@nyu.edu"}],"primaryOutcomes":["Post-traumatic stress disorder (PTSD) Checklist 5","Patient Health Questionnaire-9 (PHQ-9)","Parenting Sense of Competence Scale (PSOC)"],"hasResults":false,"conditionSlugs":["als","depression","ptsd"],"drugSlugs":[],"locationSlugs":["el-paso-texas","killeen-texas","san-antonio-texas"],"enrichment":{"headline":"Not a traditional drug phase: Parenting-STAIR Modular (PSTAIR-M) for PTSD","inPlainEnglish":"The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10). PSTAIR-M aims to help mothers manage the strong feelings that sometimes happen after experiencing something scary or stressful, as well as to better connect with their children and manage their behavior effectively.","whoItsFor":["Ages 18 Years to any","Women only","Military-connected mother, defined as a mother who is either a female service member or veteran or female spouse of a service member or veteran;","Has a child aged 2-10;","Legal guardian of index child with legal and physical custody;","Lifetime trauma exposure (Life Events Checklist (LEC-5); Adverse Childhood Experiences Questionnaire (ACE-Q));","Screen positive for PTSD (defined as a PCL-5 score ≥32 or meeting ≥3 out of 4 DSM-5 symptom criteria \\[B, C, D, E\\] on the PCL-5), and/or depression (PHQ-9 score ≥8), and/or low parenting self-how well it works (PSOC score \\<59);","Eligible to receive services at a Steven A. Cohen Military Family Clinic at Endeavors"],"whoShouldSkip":["High risk for suicide (Ask Suicide-Screening Questions (ASQ));","Current psychotic symptoms (DSM-5-TR Self-Rated Level 1 Cross-Cutting Symptom Measure Domain VII);","Disability affecting communication, such as deafness;","Index child with severe developmental disability;","Severe substance or alcohol use (The Alcohol, Smoking and Substance Involvement Screening Test - Lite (ASSIST-Lite); Cannabis Use Disorder Identification Test-Short Form (CUDIT-SF));","Currently receiving another trauma-focused individual mental health treatment"],"whatHappens":"If you join, the listed intervention(s) are Parenting-STAIR Modular (PSTAIR-M). The registry lists allocation as na. The goal of this study is to assess Parenting STAIR Modular (PSTAIR-M), a promising and innovative intervention for military-connected mothers (MCM) who have experienced trauma and their young children (ages 2-10).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.404Z"},{"nctId":"NCT06262633","title":"A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer: The VIOLETTA Trial","officialTitle":"A Multi-centre Trial on Targeted Microwave Ablation (TMA) for Localized Prostate Cancer Using Organ Based Tracking (OBT) Navigation: The VIOLETTA Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"This study is to investigate the efficacy of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.","conditions":["Prostate Cancer"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation"}],"enrollment":110,"startDate":"2024-03-15","completionDate":"2029-08-31","sex":"MALE","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n(i) Men aged ≥50 years old (ii) Life expectancy \\> 10 years upon recruitment (iii) Able to understand the trial and can provide informed and written consent, dated and signed before the enrollment and before any exam required by the trial (iv) Localized intermediate risk prostate cancer diagnosed on MRI-Ultrasound fusion targeted biopsy (v) Organ-confined prostate cancer on MRI (vi) PSA \\< 20 ng/mL (vii) 1-2 MRI visible lesion present with maximal tumor dimension ≤15mm, with targeted biopsy showing:\n\n* ISUP grade group 2 or 3 PCa\n* Systematic biopsies showing grade group 1-3 PCa just next to the MRI lesion is allowed\n* Systematic biopsies showing grade group 1 PCa far away from the lesion is allowed\n\nExclusion criteria:\n\n(i) Patients not fit for general or spinal anaesthesia (ii) Patients unfit for MRI exam or MR gadolinium contrast (e.g. estimated glomerular filtration rate (eGFR) of \\<50 ml/min) (iii) Patients with coagulopathy that cannot be corrected (iv) Patients on anticoagulants or antiplatelets that cannot be stopped (Low dose Aspirin, e.g. 80-100mg, is acceptable and no need to stop before or during TMA treatment) (v) Patients with previous treatment of prostate cancer (vi) Patients with prior pelvic radiotherapy for prostate cancer or other cancer (vii) Patients with maximal length of target lesion \\>15mm (viii) Patients with MRI lesion within 10mm from rectum or 10mm from sphincter on MRI (ix) Patients with \\>2 areas (MRI-visible or invisible) of prostate cancer (x) Patients with Gleason score 4+4 or any Gleason pattern 5 cancer (xi) Patients with systematic cores showing any Gleason 4 pattern PCa which are not adjacent to the target lesions (1 core of Gleason 3 pattern PCa on systematic cores in contralateral lobe is acceptable) (xii) Patients with definite extracapsular disease on imaging (prostate capsular contact without definite extra-capsular extension is acceptable) (xiii) Patients with bladder pathology including bladder stone or bladder cancer (xiv) Patients with known urethral stricture","locations":[{"facility":"Peter Ka-Fung CHIU","city":"Shatin","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Peter Ka-Fung CHIU, PhD,MBChB","phone":"35052625","email":"peterchiu@surgery.cuhk.edu.hk"}],"primaryOutcomes":["The oncological control of prostate cancer"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["shatin-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation for Prostate Cancer","inPlainEnglish":"This study is to investigate the how well it works of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.","whoItsFor":["Ages 50 Years to any","Men only","ISUP grade group 2 or 3 PCa","Systematic biopsies showing grade group 1-3 PCa just next to the MRI lesion is allowed","Systematic biopsies showing grade group 1 PCa far away from the lesion is allowed"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Targeted Microwave Ablation (TMA) for localized prostate cancer using organ based tracking (OBT) navigation. The registry lists allocation as na. This study is to investigate the how well it works of Targeted Microwave Ablation (TMA) under MRI-Ultrasound fusion and organ-based tracking (OBT) navigation in localized prostate cancer (PCa) in a multi-centre trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 110 people at Shatin. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.316Z"},{"nctId":"NCT06263491","title":"Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients","officialTitle":"Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.","conditions":["Mantle Cell Lymphoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rituximab"},{"type":"DRUG","name":"Pirtobrutinib"}],"enrollment":50,"startDate":"2024-05-29","completionDate":"2028-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nThe study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment.\n\n1. Age ≥ 18 years old\n2. Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC.\n3. Newly diagnosed MCL with no prior therapy for MCL (age \\>= 18 years)\n\n   • Low risk - Ki-67% (\\<= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \\<= 3 cm.\n   * Medium risk - Ki-67% (\\<=50%), largest tumor size \\<=5 cm, no features of high-risk disease (see below in exclusion)\n4. Participants with preexisting well-controlled cardio-vascular comorbidities - participants on anticoagulants (excluding warfarin and vitamin K antagonists), antiplatelet, anti-hypertensive, prior ablation, anti-arrhythmia, prior arrhythmias, baseline EKG abnormalities and cardiology clearance are allowed. Ejection fraction \\>=50% and cardiology evaluation may be needed. (Echo and EKG and cardiology consultation within 2 months prior to C1D1 are allowed).\n5. Understand and voluntarily sign an IRB-approved informed consent form.\n6. Participants may have at least 1 site of radiographically assessable disease (i.e., lymph node longest diameter \\[LDi\\] \\>= 1.5 cm, not necessary for disease assessable by positron emission tomography \\[PET\\]/computerized tomography \\[CT\\], extra nodal site \\>= 1.0 cm in LDi. But participants with isolated gastrointestinal, bone marrow or spleen only disease patients are allowed.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (See Appendix III).\n8. Prothrombin time (or international normalized ratio) and partial thromboplastin time not to exceed 1.2 times the institutional upper limit of normal range (participants with an elevated prothrombin time and known lupus anticoagulant may be eligible for participation after consulting the study PI).\n\n9A. Adequate BM function independent of growth factor or PRBC or platelet transfusion support (within 14 days of Screening assessment and criteria must be met on C1D1 without transfusion/G-CSF within 7 days of assessment, per local laboratory reference range at screening as follows:\n\na. platelet count \\>=75,000/mm3; b. absolute neutrophil count (ANC) \\>= 1000/mm3 unless cytopenia is clearly due to marrow involvement from MCL c. total hemoglobin \\>= 8 g/dL (without transfusion support within 2 weeks of screening); If any of the above-mentioned cytopenias (a-c) are present due to significant BM involvement, at least 30% BM involvement by MCL (requiring transfusion or granulocyte colony-stimulating factor \\[G-CSF\\] support) MCL patients may proceed with enrollment after discussion with the PI or Co-PI. Cytopenias may not be due to evidence of myelodysplastic syndrome (MDS) or hypoplastic BM.\n\n9B. Adequate organ function as defined by the following laboratory values:\n\na. Creatinine clearance. \\>=30 mL/min (by Cockcroft-Gault method, APPENDIX I), b. Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement and/or Gilbert's Disease or controlled immune hemolysis or considered an effect of regular blood transfusions.\n\nc. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\<3 x ULN, or \\< 5 x upper limit of normal if hepatic metastases are present.\n\n10\\. Projected life expectancy of \\>12 weeks pertaining to lymphoma. 11. Female participants must be surgically sterile, postmenopausal (for at least 1 year), or have confirmed negative results for a pregnancy test at screening, on a serum sample obtained within 7 days prior to initiation of study treatment.\n\n12\\. Women of childbearing potential and men with female partners of childbearing potential must be willing to use a highly effective form of contraception for at least 1 month after the last dose of study treatment. Participant enrolled into the Pirtobrutinib+ rituximab study should use a highly effective form of contraception for 1 month after the last dose of Pirtobrutinib and 12 months after the last dose of rituximab, whichever time period is longer. Recommended methods of highly effective birth control are:\n\n1. Combined estrogen and progestin containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally\n2. Progestin-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant\n3. Intrauterine device (IUD)\n4. Intrauterine hormone-releasing system (IUS)\n5. Vasectomized partner\n6. Sexual abstinence: considered a highly effective method only if defined as refraining from heterosexual intercourse during an entire period of risk associated with the study treatment. The reliability of sexual abstinence will be evaluated in relation to the duration of the study and to the usual lifestyles of the participant.\n7. Female sterilization\n8. Fallopian tube implants (if confirmed by hysterosalpingogram) 13. Oocyte donation is prohibited during the duration of participation on this protocol and for 1 month after the last dose of Pirtobrutinib.\n\nExclusion Criteria:\n\n1. Participants with central nervous system involvement with mantle cell lymphoma or with suspected or confirmed progressive multifocal leukoencephalopathy (PML) are excluded since those participants have very poor prognosis, need aggressive intensive chemoimmunotherapy and intrathecal chemotherapy along with BTK inhibitors and these participants would not be eligible for this study.\n2. High risk MCL - any or all of the following (Blastoid/pleomorphic histology), High Ki-67 (\\>50%), Bulky disease (nodes \\>5 cm, spleen \\>20 cm), lymphocytosis \\>=50,000 cells/uL, TP53 mutated or del17p by FISH. Presence of MYC rearrangement positive by FISH or MYC, Bcl2 amplification, complex karyotype or high-risk biologic MIPI (with Ki-67%)\n3. Major surgery within 4 weeks prior to registration\n4. History of bleeding diathesis\n5. Known active CMV. Unknown or negative status are eligible\n6. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and medical monitor may pose a risk for participant participation. Screening for chronic conditions is not required\n7. Clinically significant cardiovascular diseases as determined after cardiology consultation, including uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months of screening or any Class 3 (moderate) or 4 (severe) cardiac disease following the New York Heart Association Classification. Otherwise, significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree AV block type II, 3rd degree block, bradycardia, or QTc \\>470 msec.\n8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n9. Pregnancy or plan to become pregnant during the study or within 1-month post pirtobrutinib or 12 months post Rituxan. (Note: post rituxan, WOCBP should not become pregnant for 12 months post last dose of rituxan).\n10. Lactation during the study or for 1 week after last dose of pirtobrutinib (Note that the USPI for rituxan recommends no lactation during treatment and for 6 months after last dose)\n11. Current treatment with certain strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers and/or strong P-gp inhibitors. Because of their effect on CYP3A4, use of any of the following within 3 days of study therapy start or planned use during study participation is prohibited - grapefruit or grapefruit products, Seville oranges or products from Seville oranges, star fruit\n12. Participants taking warfarin and/or equivalent vitamin K antagonists\n13. Has difficulty with or is unable to swallow oral medication or has significant gastrointestinal disease that would limit absorption of oral medication.\n14. History of stroke or intracranial hemorrhage within 6 months of C1D1\n15. Vaccination with live vaccine within 28 days prior to enrollment.\n16. Have a known hypersensitivity to any of the excipients of Pirtobrutinib or rituximab\n17. Participants who experienced a major bleeding event or grade ≥ 3 arrhythmia on prior treatment with a BTK inhibitor. NOTE: Major bleeding is defined as bleeding having one or more of the following features: potentially life-threatening bleeding with signs or symptoms of hemodynamic compromise; bleeding associated with a decrease in the hemoglobin level of at least 2g per deciliter; or bleeding in a critical area or organ (e.g., retroperitoneal, intraarticular, pericardial, epidural, or intracranial bleeding or intramuscular bleeding with compartment syndrome).\n18. Participants who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK-inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrollment\n19. Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below: Hepatitis B virus (HBV): Participants with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before enrollment. Participants who are hepatitis B PCR positive will be excluded unless cleared by infectious disease. If a participant is Hep B core antibody positive, they must be on an approved nucleos(T)ide analogue to help prevent reactivation. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, participant will need to have a negative result for hepatitis C ribonucleic acid (RNA) before enrollment, unless cleared by infectious disease. Participants who are hepatitis C RNA positive will be excluded.\n20. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral including CMV, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator and IND sponsor may pose a risk for patient participation. Screening for chronic conditions is not required.\n21. Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec on one electrocardiograms (ECGs), during Screening. EKG might be repeated same day to check for any physiologic variation. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT/(RR0.33).\n22. Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation.\n23. Correction for underlying bundle branch block (BBB) allowed. Note: Participants with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker.\n24. Concomitant malignancies or previous malignancies with less than a 1-year disease-free interval at the time of signing consent. Subjects with adequately treated basal or squamous cell carcinoma of the skin, or adequately treated carcinoma in situ (e.g. cervix) may enroll irrespective of the time of diagnosis. Patients with controlled, advanced prostate cancer (not on active chemotherapy) are permitted. Active second malignancy unless in remission with life expectancy \\> 1 years. Examples include:\n\n    1. Adequately treated no melanomatous skin cancer or lentigo maligna melanoma without current evidence of disease.\n    2. Adequately treated cervical carcinoma in situ without current evidence of disease.\n    3. Localized (e.g., lymph node negative) breast cancer treated with curative intent with no evidence of active disease present for more than 3 years and receiving adjuvant hormonal therapy.\n    4. Localized prostate cancer undergoing hormonal therapy.\n25. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.\n26. With known allergies to xanthine oxidase inhibitors and/or rasburicase.\n27. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and/or would make the participant inappropriate for enrollment into this study.\n28. No concomitant anticancer therapies, immunotherapies, cellular, or radiotherapy. No major surgery within 4 weeks prior to first dose of study treatment.\n29. Uncontrolled autoimmune hemolytic anemia (AIHA) or immune thrombocytopenia. Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) is for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts.\n30. Concomitant steroids for disease related pain control are allowed at any dose but must be discontinued prior to any study treatment initiation. Chronic use of corticosteroids is allowed up to 20 mg prednisone or equivalent daily for non-cancer related conditions at the time of study start.\n31. History of GVHD, allogeneic HSCT transplant, allogeneic organ transplant\n32. Any serious medical condition including but not limited to, uncontrolled hypertension, diabetes mellitus, active/symptomatic coronary artery disease, COPD, renal failure, active infection, active hemorrhage, laboratory abnormality, or psychiatric illness that places the participant at unacceptable risk and would prevent the subject from signing the informed consent form.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ranjit Nair, MD","phone":"713-745-8041","email":"rnair@mdanderson.org"}],"primaryOutcomes":["Safety and adverse events (AEs)"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Rituximab for Mantle Cell Lymphoma","inPlainEnglish":"To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.","whoItsFor":["Ages 18 Years to any","The study will enroll 50 previously untreated low and medium risk MCL patients. Estimated 3 patients per month at minimum for enrollment","Pathology confirmed diagnosis of mantle cell lymphoma. CD20 positivity is needed. Cyclin D1 negative MCL are allowed after confirming the diagnosis of MCL from hem-path at MDACC","Newly diagnosed MCL with no prior therapy for MCL (age \\>= 18 years)","Low risk - Ki-67% (\\<= 30%), no features of high-risk disease (see below in exclusion), largest tumor size \\<= 3 cm","Medium risk - Ki-67% (\\<=50%), largest tumor size \\<=5 cm, no features of high-risk disease (see below in exclusion)","Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less (See Appendix III)","9B. Adequate organ function as defined by the following laboratory values:"],"whoShouldSkip":["Major surgery within 4 weeks prior to registration","History of bleeding diathesis","Known active CMV. Unknown or negative status are eligible","Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction","Pregnancy or plan to become pregnant during the study or within 1-month post pirtobrutinib or 12 months post Rituxan. (Note: post rituxan, WOCBP should not become pregnant for 12 months post last dose of rituxan)","Lactation during the study or for 1 week after last dose of pirtobrutinib (Note that the USPI for rituxan recommends no lactation during treatment and for 6 months after last dose)","Participants taking warfarin and/or equivalent vitamin K antagonists"],"whatHappens":"If you join, the listed intervention(s) are Rituximab, or Pirtobrutinib. The registry lists allocation as randomized. To learn if the chemotherapy-free combination of pirtobrutinib (also called LOXO-305) and rituximab can help provide long term remission in low and intermediate risk MCL.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.150Z"},{"nctId":"NCT06267781","title":"RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies","officialTitle":"Biomarkers of Disease PROgression and Myeloid Profiling in Patients With Relapsing Remitting Multiple Sclerosis Treated With Autologous Hematopoietic Stem Cell TRANSPLANTation and Second Line Therapies.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS San Raffaele","sponsorClass":"OTHER","summary":"To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[],"enrollment":30,"startDate":"2022-09-02","completionDate":"2027-09-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years;\n* Signed written informed consent;\n* A diagnosis of RRMS according to the 2017 Revisions of the McDonald Criteria;\n* High clinical and magnetic resonance imaging (MRI) inflammatory disease activity (at least 2 clinical relapses, or one clinical relapse with gadolinium (Gd)- enhancing or new T2 MRI lesions at a separate time point, in the previous 12 months)\n* Patients referred for pharmacological treatment with aHSCT, alemtuzumab or ocrelizumab /ofatumumab, according to clinical practice following the Italian pharmacological regulatory agency (AIFA) criteria and guidelines and recommendations from the European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE);\n\nExclusion Criteria:\n\n* Diagnosis of PPMS or SPMS according to the 2017 McDonald criteria\n* Known intolerances/allergies to the active substance or the excipients contained in the DMT and/or contraindications according to product information","locations":[{"facility":"IRCCS San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Angela Genchi","phone":"+390226452846","email":"genchi.angela@hst.it"},{"name":"Lucia Moiola","phone":"+390226452931","email":"moiola.lucia@hsr.it"}],"primaryOutcomes":["Number of fading/disappearing paramagnetic rim lesions (PRLs)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"RRMS: Disease PROgression and Myeloid Profiling After Bone Marrow TRANSPLANTation and Second Line Therapies","inPlainEnglish":"To study whether highly effective therapies can halt disease progression in people with multiple sclerosis by modulating the peripheral myeloid landscape.","whoItsFor":["Ages 18 Years to any","A diagnosis of RRMS according to the 2017 Revisions of the McDonald Criteria;","High clinical and magnetic resonance imaging (MRI) inflammatory disease activity (at least 2 clinical relapses, or one clinical relapse with gadolinium (Gd)- enhancing or new T2 MRI lesions at a separate time point, in the previous 12 months)"],"whoShouldSkip":["Diagnosis of PPMS or SPMS according to the 2017 McDonald criteria","Known intolerances/allergies to the active substance or the excipients contained in the DMT and/or contraindications according to product information"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Milan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.997Z"},{"nctId":"NCT06271330","title":"Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.","officialTitle":"A Multicenter Real-life Observational Retrospective Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With Refractory or Dependent Exudative AMD","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Nantes University Hospital","sponsorClass":"OTHER","summary":"Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \\[1\\] and aflibercept \\[2\\] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound \\[3\\] is that it extends the injection interval in the Treat and Extend (T\\&E) protocol, which is more extensive than with previous anti-VEGF agents.\n\nThe patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections.\n\nAs the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.","conditions":["Age-related Macular Degeneration"],"keywords":[],"interventions":[{"type":"DRUG","name":"Faricimab"}],"enrollment":100,"startDate":"2024-04-01","completionDate":"2025-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept \\> 1 year.\n* Patient whose IVT injection interval is strictly less than 12 weeks.\n\nExclusion Criteria:\n\n* Severe myopia (axial length \\> 26 mm or sphere \\< - 6 dioptres).\n\n  * Presence of angioid striae.\n  * Presence of moderate or more severe diabetic retinopathy.\n  * History of diabetic macular edema.\n  * History of uveitis.\n  * Previous retinal vein occlusion (branch or central vein).\n  * History of pseudovitelliform macular dystrophy.\n  * Patient under guardianship or trusteeship\n  * Pregnant or breast-feeding woman","locations":[{"facility":"Ducloyer","city":"Nantes","state":"Nantes","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jean-Baptiste Ducloyer, M.D","phone":"02 40 08 34 01","email":"jeanbaptiste.ducloyer@chu-nantes.fr"},{"name":"Alexandra Poinas, PhD","phone":"0253482857","email":"alexandra.poinas@chu-nantes.fr"}],"primaryOutcomes":["Difference in number of weeks between previous treatment (ranibizumab or aflibercept) and after 6 months of Faricimab treatment."],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["nantes-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Faricimab for Age-related Macular Degeneration","inPlainEnglish":"Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab \\[1\\] and aflibercept \\[2\\] in the 2010s.","whoItsFor":["Ages 18 Years to any","Male or female patient of legal age (≥18 years) with exudative AMD treated with IVT ranibizumab or aflibercept \\> 1 year","Patient whose IVT injection interval is strictly less than 12 weeks"],"whoShouldSkip":["Severe myopia (axial length \\> 26 mm or sphere \\< - 6 dioptres)","Presence of angioid striae","Presence of moderate or more severe diabetic retinopathy","History of diabetic macular edema","History of uveitis","Previous retinal vein occlusion (branch or central vein)","History of pseudovitelliform macular dystrophy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Nantes. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.132Z"},{"nctId":"NCT06274554","title":"Testing the Role of Anti-fungal Therapy in Improving the Response to Therapies for Crohn's Disease","officialTitle":"A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Weill Medical College of Cornell University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease.\n\nThe main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.","conditions":["Crohn's Disease","Inflammatory Bowel Diseases"],"keywords":["Fluconazole","IL-23"],"interventions":[{"type":"DRUG","name":"Fluconazole"},{"type":"DRUG","name":"Placebo"},{"type":"BIOLOGICAL","name":"IL-23 Therapy"}],"enrollment":120,"startDate":"2024-10-04","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients at least 18 years old\n2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450\n\nExclusion Criteria:\n\n1. Antifungal usage within one month prior to initiation of blinded fluconazole usage\n2. Known allergy to fluconazole\n3. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \\>3X upper limit of normal (ULN), and/or bilirubin levels \\>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline\n4. Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc\n5. Pregnant or lactating women\n6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician\n7. Patient with symptomatic stricturing\n8. Patient with pouchitis or an ostomy\n9. Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies.\n10. Patients with hypokalemia, or advanced cardiac failure\n11. Patients with renal insufficiency","locations":[{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emely Fernandez, BS","phone":"646-697-0985","email":"emf4006@med.cornell.edu"},{"name":"Emilia Vignogna, BS","phone":"646-697-0985","email":"etv4001@med.cornell.edu"}],"primaryOutcomes":["Proportion of subjects achieving clinical response"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 3: testing Fluconazole for Crohn's Disease","inPlainEnglish":"The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease. The main question it aims to assess is whether or not patient response to IL-23 therapies improve when simultaneously treated with fluconazole.","whoItsFor":["Ages 18 Years to any","Patients at least 18 years old","Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450"],"whoShouldSkip":["Antifungal usage within one month prior to initiation of blinded fluconazole usage","Known allergy to fluconazole","Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \\>3X upper limit of normal (ULN), and/or bilirubin levels \\>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline","Pregnant or lactating women","Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician","Patient with symptomatic stricturing","Patient with pouchitis or an ostomy"],"whatHappens":"If you join, the listed intervention(s) are Fluconazole, Placebo, or IL-23 Therapy. The registry lists allocation as randomized. The goal of this clinical trial is to learn about the effects of fluconazole in patients who plan to start or are currently undergoing standard of care treatment and plan to dose-escalate an IL-23 therapy for their Crohn's disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 120 people at New York. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.579Z"},{"nctId":"NCT06274749","title":"Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial","officialTitle":"The Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults >= 55 Years Old. A Randomized Triple-Masked Controlled Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"National Institute on Aging (NIA)","sponsorClass":"NIH","summary":"Background:\n\nAs people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes. Urolithin A (UA) is a natural nutritional supplement that may improve how the body controls blood glucose.\n\nObjective:\n\nTo learn if UA improves levels of insulin and other hormones that help control blood glucose.\n\nEligibility:\n\nPeople aged 55 years and older with a body mass index of 27 or higher.\n\nDesign:\n\nParticipants will have 6 clinic visits over 8 weeks.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests and a test of their heart function.\n\nUA gelcaps are taken by mouth every morning at home. Half of participants will take UA. The other half will take a placebo. The placebo looks like the study drug but does not contain any medicine. Participants will not know which they are taking.\n\nParticipants will have tests during the study including:\n\nOral glucose tolerance: Participants will drink a sweet liquid. Blood will be drawn at intervals over the next 3 hours.\n\nContinuous glucose monitor: A sensor with a needle that goes just under the skin will be placed on the upper arm. Participants will wear this sensor throughout the study.\n\nExercise. Participants will walk on a treadmill while their heart rate, hearth rhythm, and blood pressure are monitored. They will walk in a hallway at normal and fast paces.\n\nImaging scans of the thigh; scans of the brain are optional....","conditions":["Healthy Volunteer"],"keywords":["Urolithin A","GLUCOSE METABOLISM","Insulin","Muscle Strength","Microbiomes"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Urolithin A"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":180,"startDate":"2026-11-15","completionDate":"2027-03-31","sex":"ALL","minAge":"55 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availably for the duration of the study.\n* Male or female, age \\>= 55 years.\n* Able to speak and read English. (We do not have ready access to interpreters of different languages at the NIA Clinical Unit).\n* BMI \\>= 27.\n* Ability to take oral medication and be willing to adhere to the daily regimen.\n* Ability to perform walking and treadmill tests without physical limitations.\n* In good general health, as evidenced by medical history/physical exam/laboratory results.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* History of diabetes requiring treatment with any glucose lowering drug(s).\n* Fasting glucose \\>= 126 on screening visit.\n* Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment.\n* Hospitalization within 12 months for myocardial infarction, coronary revascularization or bypass surgery or stroke.\n* History of autoimmune disease, e.g., Hashimoto s thyroiditis, Myasthenia Gravis or Rheumatoid Arthritis.\n* Uncontrolled thyroid disease.\n* Chronic liver disease indicated by medical history or one of the liver enzymes greater than 2 times the normal range.\n* History of chronic kidney disease or GFR \\<60 mL/min/1.73 m\\^2.\n* Anemia (defined as hemoglobin level \\<12 g/dl for men or \\< 11 g/dl for women).\n* Poor venous access.\n* Uncontrolled hypertension as judged by the Investigator.\n* History of significant GI disease, e.g., IBS, Crohn s disease.\n* Active cancer or has had treatment for cancer in the last 1 year.\n* Medical condition requiring absolute and continuous need for long-term treatment with antibiotics, corticosteroids, immunosuppressors.\n* Currently pregnant or a nursing mother due to possible changes in hormones and metabolism.\n* History of, or laboratory evidence of HIV virus infection at Screening Visit.\n* History of, or laboratory evidence of Hepatitis B or C at Screening Visit.\n* Positive urine drug screen at Screening Visit (unless taking prescribed medication and at the discretion of the PI).\n* Reports claustrophobia and/or is not eligible to have an MRI as per the MRI eligibility form.\n* Weight \\>= 300 lbs (MRI scanner weight limit).\n* Hip or knee replacement or other medical condition that prevents MRI research scans from being performed.\n* Diagnosed with cognitive impairment that clearly prevents the participant from providing informed consent.\n* Current smoker or tobacco use in the past year.\n* History of substance abuse, including marijuana use in the past year.\n* On average, consumes more than 1 alcoholic drink per day.\n* Any other condition which in the investigator s opinion may adversely affect the subject s ability to complete the study or its measures or which may pose significant risk to the subject.","locations":[{"facility":"National Institute of Aging, Clinical Research Unit","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Denise L Melvin, R.N.","phone":"(410) 350-3924","email":"melvinde@mail.nih.gov"},{"name":"Josephine M Egan, M.D.","phone":"(410) 558-8414","email":"eganj@mail.nih.gov"}],"primaryOutcomes":["To determine if urolithin A supplementation will influence insulin secretion in response to oral glucose at 4 and 8 weeks after supplementation."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Urolithin A for Healthy Volunteer","inPlainEnglish":"Background: As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise. This can lead to illnesses such as diabetes.","whoItsFor":["Ages 55 Years to 100 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availably for the duration of the study","Male or female, age \\>= 55 years","Able to speak and read English. (We do not have ready access to interpreters of different languages at the NIA Clinical Unit)","Ability to take oral medication and be willing to adhere to the daily regimen","Ability to perform walking and treadmill tests without physical limitations","In good general health, as evidenced by medical history/physical exam/laboratory results"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","History of diabetes requiring treatment with any glucose lowering drug(s)","Fasting glucose \\>= 126 on screening visit","Is on treatment with an investigational drug or other intervention within 8 weeks of enrollment","Hospitalization within 12 months for myocardial infarction, coronary revascularization or bypass surgery or stroke","History of autoimmune disease, e.g., Hashimoto s thyroiditis, Myasthenia Gravis or Rheumatoid Arthritis","Uncontrolled thyroid disease"],"whatHappens":"If you join, the listed intervention(s) are Urolithin A, or Placebo. The registry lists allocation as randomized. Background: As people age, the cells in the pancreas that produce insulin begin to release less of this hormone, and levels of blood glucose (sugar) rise.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 180 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.256Z"},{"nctId":"NCT06278207","title":"An Observational Study Called FINEROD to Learn More About the Use of the Treatment Finerenone Including How Safe it is and How Well it Works Under Real-world Conditions","officialTitle":"Finerenone Research of Outcomes and Drug Utilization","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Bayer","sponsorClass":"INDUSTRY","summary":"This is an observational study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors. In observational studies, only observations are made without specified advice or interventions. CKD is a long-term progressive decrease in the kidneys' ability to work properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough. The resulting high blood sugar levels can cause damage to the kidneys. CKD often occurs together with T2D or as a consequence of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. By doing this, it may reduce damage to kidneys, heart and blood vessels. Finerenone was recently approved in the US and is now available for doctors to prescribe to people with CKD together with T2D. Consequently, there is a need to collect more information about how finerenone is used, its safety and how well it works under real-world conditions. The main purpose of this study is to collect and describe the characteristics of people with CKD and T2D who are receiving initiate finerenone treatment as prescribed by their doctors. To do this, the researchers will collect general information of the participants such as age or gender and data on kidney function and possible heart problems.\n\nThe researchers will also collect data on any other disease or medical condition in the participants and on other medications used while taking finerenone.\n\nThe data will come from a network of commercial electronic health records (EHRs) and national claims data in the United States and in Asia. They cover the period from July 1st, 2021 until the latest data cut available for each dataset. Only already available data is collected and studied. There are no required visits or tests in this study.","conditions":["Chronic Kidney Disease","Type 2 Diabetes Mellitus"],"keywords":[],"interventions":[{"type":"DRUG","name":"Finerenone (BAY 94-8862)"}],"enrollment":50000,"startDate":"2024-05-15","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used\n* No recorded prescription for finerenone in the 12 months prior to the index date\n* Age of 18 years or older as of the index date\n* Evidence of T2D at any point before (and including) the index date.\n* CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:\n\n  * A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified\n  * two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days\n  * two different eGFR test results ≥ 15 mL/min/1.73 m2 AND \\< 60 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days\n\nExclusion Criteria:\n\n\\- Kidney failure defined as follows:\n\n* Two different eGFR test results \\< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;\n* Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);\n* A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant","locations":[{"facility":"Many Locations","city":"Many Locations","state":"New Jersey","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Bayer","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Many Locations","city":"Many Locations","state":"","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"Many Locations","city":"Many Locations","state":"","country":"Taiwan","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Bayer Clinical Trials Contact","phone":"(+)1-888-84 22937","email":"clinical-trials-contact@bayer.com"}],"primaryOutcomes":["Participants' characteristics at baseline in a cohort of participants with CKD and T2D who initiate finerenone.","Participants' comorbidities at baseline in a cohort of participants with CKD and T2D who initiate finerenone.","Participants' comedications at baseline in a cohort of participants with CKD and T2D who initiate finerenone."],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["many-locations-new-jersey","berlin-germany","many-locations-japan","many-locations-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: testing Finerenone (BAY 94-8862) for Chronic Kidney Disease","inPlainEnglish":"This is an watch-and-measure (no experimental treatment required) study, in which data from people in Asia and in the United States with chronic kidney disease (CKD) together with type 2 diabetes (T2D) are studied. The participants in this study are already receiving the study treatment finerenone as part of their regular care from their doctors.","whoItsFor":["Ages 18 Years to any","A minimum of 12 months of continuous enrolment in the databases with medical and pharmacy coverage measured as continuously receiving medical care from health providers contributing to the EHR or claims system, depending on the database used","No recorded prescription for finerenone in the 12 months prior to the index date","Age of 18 years or older as of the index date","Evidence of T2D at any point before (and including) the index date","CKD stages 2-4 related to eligibility will be defined according to the presence of the following criteria at any point before (and including) the index date:","A diagnosis code indicating CKD stage 2, 3, 4 or stage unspecified","two UACR tests results ≥ 30 mg/g separated by at least 90 days and by not more than 540 days"],"whoShouldSkip":["\\- Kidney failure defined as follows:","Two different eGFR test results \\< 15 mL/min/1.73 m2 separated by at least 90 days and by not more than 540 days;","Dependence on dialysis (at least 3 sessions over at least 90 days during the baseline period);","A diagnosis code indicating kidney failure or CKD stage 5; Kidney transplant"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50,000 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.524Z"},{"nctId":"NCT06278779","title":"Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-resistant Depression","officialTitle":"Comparative Effectiveness Study of Two Forms of Ketamine for Treatment-Resistant Depression: a Randomised, Rater-blinded Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"The George Institute","sponsorClass":"OTHER","summary":"The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are:\n\n* How the two formulations compare in terms of their effectiveness in treating TRD.\n* How the two formulations compare in their acceptability to patients, safety, effects on patient quality of life and function, and cost effectiveness.\n\nParticipants will be randomised to receive either Spravato® or racemic ketamine treatment and asked to complete some questionnaires to assess the effects on mood, treatment acceptability, side effects, quality of life and function, and health economic outcomes.","conditions":["Treatment Resistant Depression"],"keywords":[],"interventions":[{"type":"DRUG","name":"Esketamine group"},{"type":"DRUG","name":"Racemic ketamine"}],"enrollment":162,"startDate":"2024-06-03","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)\n* Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD\n* MADRS score of ≥20 at study baseline, assessed by certified study rater\n* Aged ≥18 years\n* Written informed consent for research study obtained\n\nExclusion Criteria:\n\n* Not able to give informed consent\n* Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments\n* Any treatment with ketamine or Spravato® within 4 weeks prior to written informed consent for the research study\n* Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales","locations":[{"facility":"Royal Prince Alfred Hospital","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Black Dog Institute","city":"Randwick","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Clinic Northside","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Clinic Lakeside","city":"Warners Bay","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gold Coast University Hospital","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Clinic Albert Road","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Melbourne Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Abigail Hansen","phone":"80524300","email":"Trek@georgeinstitute.org.au"},{"name":"Fay Wang","phone":"80524300","email":"Trek@georgeinstitute.org.au"}],"primaryOutcomes":["Montgomery-Asberg Depression Rating Scale (MADRS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["camperdown-australia","randwick-australia","st-leonards-australia","warners-bay-australia","southport-australia","melbourne-australia","parkville-australia"],"enrichment":{"headline":"Phase 4: testing Esketamine group for Treatment Resistant Depression","inPlainEnglish":"The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD). The main questions it aims to answer are: * How the two formulations compare in terms of their effectiveness in treating TRD.","whoItsFor":["Ages 18 Years to any","Adult with treatment-resistant depression (TRD: not responded adequately to at least two different antidepressants of adequate dose and duration) who has a current depressive episode (DSM 5)","Assessed and attested by clinic psychiatrist as appropriate to receive either racemic ketamine or Spravato® ketamine treatment for TRD","MADRS score of ≥20 at study baseline, assessed by certified study rater"],"whoShouldSkip":["Any physical or mental condition which, in the opinion of the investigator, could interfere with study participation including outcome assessments","Patients who require an interpreter/translator for the clinic consent process, due to the infeasibility of obtaining an interpreter for research assessments, including self-rated scales"],"whatHappens":"If you join, the listed intervention(s) are Esketamine group, or Racemic ketamine. The registry lists allocation as randomized. The goal of this study is to compare the effectiveness of two formulations of ketamine - Spravato® and racemic ketamine - in people with treatment-resistant depression (TRD).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 162 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.793Z"},{"nctId":"NCT06281080","title":"Performance, Feasibility, and Safety Study for a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours: First-In-Human Trial","officialTitle":"First-in-Human Trial of a Novel Endoluminal Robotic System for En-Bloc Resection of Bladder Tumours","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"This is a prospective, single-arm study to evaluate the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.","conditions":["Bladder Cancer"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"En-Bloc Resection of Bladder Tumours"}],"enrollment":10,"startDate":"2024-11-20","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age between 18 and 75 years\n2. Body mass index \\<35 kg/m2\n3. Bladder tumour located \\<3 cm in size; clinically non-muscle invasive bladder tumour\n4. Clinically indicated for en-bloc resection.\n5. Willingness to participate as demonstrated by giving informed consent\n\nExclusion Criteria:\n\n1. Presence of endoscopic or imaging signs of detrusor muscle invasion\n2. Contraindication to general anaesthesia / spinal anaesthesia\n3. ASA \\> 2 patients\n4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention\n5. Untreated active infection\n6. Un-corrected coagulopathy\n7. Presence of another malignancy or distant metastasis\n8. Emergency surgery\n9. Vulnerable population (e.g. mentally disabled, pregnant)","locations":[{"facility":"Prince of Wales Hospital","city":"Shatin","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chi Fai NG, MD","phone":"35052625","email":"ngcf@surgery.cuhk.edu.hk"}],"primaryOutcomes":["Successful en-bloc tumour resection by the robotic system"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["shatin-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: En-Bloc Resection of Bladder Tumours for Bladder Cancer","inPlainEnglish":"This is a prospective, single-arm study to measure the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.","whoItsFor":["Ages 18 Years to 75 Years","Age between 18 and 75 years","Body mass index \\<35 kg/m2","Bladder tumour located \\<3 cm in size; clinically non-muscle invasive bladder tumour","Clinically indicated for en-bloc resection"],"whoShouldSkip":["Presence of endoscopic or imaging signs of detrusor muscle invasion","Contraindication to general anaesthesia / spinal anaesthesia","Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention","Untreated active infection","Un-corrected coagulopathy","Presence of another malignancy or distant metastasis","Vulnerable population (e.g. mentally disabled, pregnant)"],"whatHappens":"If you join, the listed intervention(s) are En-Bloc Resection of Bladder Tumours. The registry lists allocation as na. This is a prospective, single-arm study to measure the feasibility and safety of performing transurethral en-bloc resection of bladder tumours using the Zenith robotic system.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Shatin. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.317Z"},{"nctId":"NCT06281899","title":"Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus","officialTitle":"Effect of the Low PROtein Diet on Top of DAPAgliflozin and RAASi on the Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Anemia Working Group Romania","sponsorClass":"OTHER","summary":"This is a prospective multicenter randomized controlled trial with a total duration of 36 months aiming to evaluate the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus","conditions":["Chronic Kidney Diseases","Type 2 Diabetes Mellitus"],"keywords":["chronic kidney disease","low protein diet","nutrition therapy"],"interventions":[{"type":"DRUG","name":"Dapagliflozin 10 mg Tab"},{"type":"BEHAVIORAL","name":"Low protein diet"}],"enrollment":200,"startDate":"2022-01-01","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* age\\>18 years old\n* confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria \\>500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus\n* stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR \\< 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline)\n* treatment with ACE/ARBs and/or MRAs for at least 3 months\n* no previous treatment with SGLT2i\n* good nutritional status\n* declared and anticipated good compliance with the prescribed diet\n* signed informed consent\n\nExclusion Criteria:\n\n* eGFR \\< 25 ml/min/1.73 m2\n* poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)\n* class IV NYHA heart failure, recent MACE (less than 6 months)\n* relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy)\n* ADPKD\n* kidney transplantation with functional graft\n* malnutrition: BMI\\<18 kg/me, eight loss \\>10% during the last 6 months, serum albumin \\<3 g/dL\n* feeding inability (anorexia, nausea)","locations":[{"facility":"Carol Davila University of Medicine and Pharmacy Bucharest","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liliana Garneata, Professor","phone":"+40722619358","email":"lilianagarna@yahoo.com"},{"name":"Elena Cuiban, PhD student","phone":"+40748975315","email":"elena.cuiban@drd.umfcd.ro"}],"primaryOutcomes":["Time to the First Occurrence of Any of the Components of the Composite: ≥30% Sustained Decline in eGFR or Reaching ESRD or CV Death or Renal Death"],"hasResults":false,"conditionSlugs":["type-2-diabetes","chronic-kidney-disease"],"drugSlugs":["dapagliflozin"],"locationSlugs":["bucharest-romania"],"enrichment":{"headline":"Phase 4: testing Dapagliflozin 10 mg Tab for Chronic Kidney Diseases","inPlainEnglish":"This is a prospective multicenter randomly assigned controlled trial with a total duration of 36 months aiming to measure the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus","whoItsFor":["Ages 18 Years to any","confirmed chronic kidney disease (with eGFR between 60 and 20 ml/min/1.73 m2 and/or proteinuria \\>500 mg/g urinary creatinine) and confirmed type 2 Diabetes Mellitus","stable kidney function for at least 12 weeks before enrollment (defined as decrease in eGFR \\< 5 ml/min/1.73 m2/year according to KDIGO 2012 guideline)","treatment with ACE/ARBs and/or MRAs for at least 3 months","no previous treatment with SGLT2i","good nutritional status","declared and anticipated good compliance with the prescribed diet"],"whoShouldSkip":["eGFR \\< 25 ml/min/1.73 m2","poorly controlled arterial blood pressure (mean BP≥145/85 mm Hg)","class IV NYHA heart failure, recent MACE (less than 6 months)","relevant comorbid conditions (active infections (HBV, HCV, HIV), active neoplasia, digestive diseases with malabsorption, active autoimmune diseases/ immunosuppressive therapy)","kidney transplantation with functional graft","malnutrition: body-mass index (BMI)\\<18 kg/me, eight loss \\>10% during the last 6 months, serum albumin \\<3 g/dL","feeding inability (anorexia, nausea)"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin 10 mg Tab, or Low protein diet. The registry lists allocation as randomized. This is a prospective multicenter randomly assigned controlled trial with a total duration of 36 months aiming to measure the effectiveness and the safety of low protein diet on top of sodium-glucose cotransporter 2 inhibitors (SGLT2i) and renin-angiotensin-aldosterone inhibitors (RAASi) in reducing the progression of chronic kidney disease in patients with type 2 Diabetes Mellitus","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 200 people at Bucharest. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.950Z"},{"nctId":"NCT06283979","title":"A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","officialTitle":"A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Biocomposites Ltd","sponsorClass":"INDUSTRY","summary":"The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.","conditions":["Pressure Ulcer, Stage IV","Osteomyelitis"],"keywords":["between-group effect size","surgical debridement","ulcer bursectomy","systemic antibiotics"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"STIMULAN VG"},{"type":"PROCEDURE","name":"Standard of Care"}],"enrollment":60,"startDate":"2025-06-15","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"In order to be eligible to participate in this study, subjects must meet all of the following criteria:\n\n1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure.\n2. Operative candidate for flap surgery or primary closure.\n3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.\n4. Adults ≥ 18 years in age at the time of treatment.\n5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.\n6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.\n\nSubjects who meet any of the following criteria will be excluded from participating in this study:\n\n1. Reasons contributing to pressure ulcer cannot be addressed.\n2. Severe immunological compromised patients as determined by the clinician.\n3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.\n4. Patients presenting with head pressure ulcers.\n5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety/recovery or ability to follow the trial procedures.\n6. Current smoker.\n7. Diabetic patient with Hba1C level above 9.\n8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).\n9. Concurrent involvement in a study of another investigational product.\n10. Pregnant or planning to become pregnant during study period.\n11. Flexion contractures where patient cannot passively get full extension.\n12. Uncontrolled muscle spasms.\n13. Unable to comply with bedrest restriction or offloading requirements\n14. Unable to provide consent.\n15. Fecal or urinary incontinence with contamination of the wound.\n16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \\*\n17. Investigator considers the participant to be clinically malnourished.\n18. Any conditions with known hypercalcemia (\\> 10.3 mg/dl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).\n19. Investigator believes trial participation may compromise safety of the participant or trial results.\n\n    * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization","locations":[{"facility":"Advanced Foot Care, LLC","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University Feinberg School of Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Mississippi Medical Center","city":"Jackson","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Missouri Orthopaedic Institute","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers New Jersey Medical School","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Hospital - Long Island Clinical Research Center","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh, McGowan Institute for Regenerative Medicine","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Keira Watts, Clinical Research Director","phone":"+44 (0) 1782 338 580","email":"clinicaltrials@biocomposites.com"},{"name":"Daniel Roberts","phone":"","email":"droberts@mcra.com"}],"primaryOutcomes":["Individual patient success and findings at the 8 week follow-up visit"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","chicago-illinois","detroit-michigan","jackson-mississippi","columbia-missouri","omaha-nebraska","newark-new-jersey","mineola-new-york","pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 2: STIMULAN VG for Pressure Ulcer, Stage IV","inPlainEnglish":"The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.","whoItsFor":["Ages 18 Years to any","In order to be eligible to participate in this study, subjects must meet all of the following criteria:","Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage/primary closure","Operative candidate for flap surgery or primary closure","Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan","Adults ≥ 18 years in age at the time of treatment","Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures","Subjects who meet any of the following criteria will be excluded from participating in this study:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are STIMULAN VG, or Standard of Care. The registry lists allocation as randomized. The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 9 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.786Z"},{"nctId":"NCT06288672","title":"IBS Skin Patch Test Food Allergy Study","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Patch Test-Guided Type 4 Food Allergen Dietary Avoidance for Irritable Bowel Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"IBS-80, LLC","sponsorClass":"INDUSTRY","summary":"Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period. The patches are taped to the back at Visit #. At Visit #2 48 hours later, the patches are removed from the skin and the outside border of each patch is marked with a felt tip marker. At Visit #3 (final visit) 1 or 2 days later, the patch test reading is performed by the doctor-investigator. An allergy is identified as a small red mark where the food was in contact with the skin for 48 hours. Those participants found to have food allergies are then placed on an avoidance diet (no calorie restriction) for 16 weeks where they either avoid eating the food(s) to which they are allergic (the \\&#34;true\\&#34; avoidance diet) or food(s) to which the testing did not show an allergy (this is called the \\&#34;sham\\&#34; avoidance diet). There is a 50/50 chance of going on either avoidance diet. The avoidance diet is assigned in such a way that neither the participant or the doctor-investigator knows which diet is being followed. After the 16 weeks, the participants answers a brief online questionnaire that asks about the IBS symptoms while following the avoidance diet. After the 16 week avoidance diet and final questionnaire are completed, those participants who were on the sham diet will be told of their true food allergies which they may try avoiding on their own.","conditions":["Irritable Bowel Syndrome"],"keywords":["irritable bowel syndrome","IBS","FODMAP","low FODMAP","IBS diet","IBS food allergy","IBS solution","IBS treatment","IBS foods","low FODMAP diet","IBS evaluation","irritable bowel syndrome treatment","irritable bowel syndrome management","IBS cause","irritable bowel syndrome pathogenesis","irritable bowel syndrome evaluation","IBS pathogenesis"],"interventions":[{"type":"OTHER","name":"True avoidance diet"},{"type":"OTHER","name":"Sham avoidance diet"}],"enrollment":250,"startDate":"2023-08-15","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or\n2. meeting the Rome IV IBS diagnostic criteria by history and having suboptimally or poorly controlled IBS symptoms.\n\nExclusion Criteria:\n\n1. Under age 18 years\n2. Pregnant\n3. Severe rash\n4. Receiving any cortisone-containing or any of the following immunosuppressive medications within two weeks prior to patch testing or plan to do so any time during the study: cyclosporine, mycophenylate mofetil, azathioprine, tacrolimus or others within these classes of medications)\n5. Incapable of completing all parts of the 18-week screening period and study, including following the dietary instructions and completing all text or email questionnaires\n6. Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwilling to discontinue the low FODMAP diet, if relevant, starting 1 week prior to the study and for the study duration\n\n8\\) Refusal to shave back hair, if relevant 9) Receiving pharmacologic therapy for IBS that has been started or changed within 30 days of study enrollment 10) Non-English speaking 11) Unable to provide written informed consent 12) Have a history of gastrointestinal disease including celiac disease, cirrhosis, gastrointestinal malignancy, inflammatory bowel disease, or diverticulitis, active within the prior 2 years. 13) Have a history of gastrointestinal surgery (except appendectomy and cholecystectomy or gallbladder removal \\&amp;gt;6 months ago) 14) Have poorly controlled psychiatric disease such as severe depression (with or without suicidal ideation), severe anxiety, schizophrenia, dementia 15) Have excessive alcohol intake (more than 1 drink per day for females and 2 drinks per day for males) 16) Use illicit substances 17) Use high-dose opiates 18) Severe allergy to adhesive tape","locations":[{"facility":"North Wales Dermatology, PLLC","city":"North Wales","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania Dermatology","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael B Stierstorfer, MD","phone":"215-699-1929","email":"mbstierstorfer@gmail.com"},{"name":"Sally Iles, BSN, MBA","phone":"617-922-1130","email":"sallyiles3@gmail.com"}],"primaryOutcomes":["Post-Avoidance Diet Relative IBS Symptom Global Assessment"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["north-wales-pennsylvania","philadelphia-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: True avoidance diet for Irritable Bowel Syndrome","inPlainEnglish":"Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies. The testing requires 3 office visits within a 4 or 5 day period.","whoItsFor":["Ages 18 Years to any","Irritable bowel syndrome diagnosed by a primary care provider, gastroenterologist or allergist; or","meeting the Rome IV IBS diagnostic criteria by history and having suboptimally or poorly controlled IBS symptoms"],"whoShouldSkip":["Incapable of completing all parts of the 18-week screening period and study, including following the dietary instructions and completing all text or email questionnaires","Exposure of back to the sun in the 2 weeks prior to patch testing Unable or unwilling to discontinue the low FODMAP diet, if relevant, starting 1 week prior to the study and for the study duration"],"whatHappens":"If you join, the listed intervention(s) are True avoidance diet, or Sham avoidance diet. The registry lists allocation as randomized. Participants with IBS are skin patch tested (no needles) to 80 different foods and food additives, compounded for patch testing, in search of food allergies.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 250 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.432Z"},{"nctId":"NCT06293053","title":"A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis","officialTitle":"A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.\n\nThe study consists of 3 periods:\n\n* Screening period: 2 to 4 weeks.\n* Treatment period: 24 weeks.\n* Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods).\n\nThe total number of planned study visits for each participant will be 6.","conditions":["Prurigo Nodularis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"}],"enrollment":18,"startDate":"2024-05-15","completionDate":"2027-10-28","sex":"ALL","minAge":"6 Months","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be ≥6 months to \\<18 years of age, at the time of signing the informed consent.\n* A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline.\n* On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to \\<18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged ≥6 months to \\<6 years at the screening visit) ranging from 0 to 10, participants must have an average worst itch score of ≥7 in the 7 days prior to Day 1.\n\nNOTE: Baseline pruritus NRS average score for maximum itch intensity will be determined based on the average of daily NRS scores for maximum intensity (the daily score ranges from 0 to 10) during the 7 days immediately preceding the Day 1/Baseline visit. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.\n\n* Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study.\n* Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Presence of active moderate to severe lesions of atopic dermatitis (AD), and/or other skin conditions that may interfere with the PN diagnosis including but not limited to the following: scabies, psoriasis, lymphomatoid papulosis, habitual picking, dermatitis herpetiformis, sporotrichosis, and bullous disease.\n* Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.\n\nNOTE: Participants may be rescreened after infection resolves.\n\n* Known or suspected immunodeficiency, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution, or otherwise recurrent infections of abnormal frequency or prolonged duration suggesting an immune compromised status, as judged by the Investigator.\n* Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.\n* Planned or anticipated major surgical procedure during the participant's participation in this clinical trial.\n* Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer.\n* Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer.\n* Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Stanford University Medical Center (CTRU)- Site Number : 8400021","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Dermatology Center- Site Number : 8400011","city":"Rancho Santa Margarita","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Golden State Dermatology - Walnut Creek - Ygnacio Valley Road- Site Number : 8400023","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Life Clinical Trials - Coral Springs- Site Number : 8400018","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Direct Helpers Research Center- Site Number : 8400015","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SunCoast Skin Solutions - Lutz- Site Number : 8400008","city":"Lutz","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USF Health- Site Number : 8400003","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tareen Dermatology - Eagan- Site Number : 8400022","city":"Eagan","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MediSearch Clinical Trials- Site Number : 8400004","city":"Saint Joseph","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AXIS Clinicals - Fargo- Site Number : 8400013","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dell Children's Medical Center- Site Number : 8400007","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Driscoll Children's Hospital- Site Number : 8400017","city":"Corpus Christi","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oakwell Clinical Research- Site Number : 8400020","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Concentration of dupilumab in serum"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["palo-alto-california","rancho-santa-margarita-california","walnut-creek-california","coral-gables-florida","coral-springs-florida","hialeah-florida","lutz-florida","tampa-florida","eagan-minnesota","saint-joseph-missouri","fargo-north-dakota","tulsa-oklahoma","austin-texas","corpus-christi-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 3: testing Dupilumab for Prurigo Nodularis","inPlainEnglish":"This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks.","whoItsFor":["Ages 6 Months to 17 Years","Participants/Caregivers must be willing and able to complete a daily symptom e-Diary for the duration of the study","Contraceptive use by male and female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period","NOTE: Participants may be rescreened after infection resolves","Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study","Planned or anticipated major surgical procedure during the participant's participation in this clinical trial","Participants who has taken biologic therapy/systemic immunosuppressant/ immunomodulator within 4 weeks before the screening visit or 5 half-lives, whichever is longer","Current participation to any clinical trial of an investigational drug or device or participation within 3 months before the screening visit or 5 half-lives of the investigational compound, whichever is longer"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab. The registry lists allocation as na. This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 18 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.707Z"},{"nctId":"NCT06295965","title":"Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers, CHANCES Study","officialTitle":"Clonal Hematopoiesis and Therapy-Emergent Myeloid Neoplasms in Patients With Cancers (CHANCES)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Washington","sponsorClass":"OTHER","summary":"This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.","conditions":["Recurrent Fallopian Tube Carcinoma","Recurrent Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Malignant Solid Neoplasm","Clonal Cytopenia of Undetermined Significance","Clonal Hematopoiesis","Idiopathic Cytopenia of Undetermined Significance","Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder","Ovarian Carcinoma","Myeloid Neoplasm Post Cytotoxic Therapy"],"keywords":[],"interventions":[{"type":"OTHER","name":"Non-Interventional Study"}],"enrollment":2000,"startDate":"2024-01-02","completionDate":"2028-12-31","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:\n\n  * Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy\n\nOR\n\n* Subjects who have or have had a solid tumor diagnosis and any of the following:\n\n  * At least 4 months of exposure to a PARP inhibitor\n  * Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm\n\nExclusion Criteria:\n\n* Individuals with a life expectancy of less than 6 months","locations":[{"facility":"Fred Hutch/University of Washington Cancer Consortium","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Swisher Lab Research Coordinators","phone":"206-616-8927","email":"swisherlabrc@uw.edu"}],"primaryOutcomes":["Determine the correlation between baseline TP53m VAF in blood with CH expansion in OC patients","Identify risk of TMN for OC survivors with and without TP53m CH treated with platinum chemotherapy and PARP inhibitors","Define the trajectories of clonal evolution and mechanisms of transformation from non-cancerous TP53m to TMN"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: Non-Interventional Study for Recurrent Fallopian Tube Carcinoma","inPlainEnglish":"This study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. Researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.","whoItsFor":["Subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and:","Have completed or plan to complete at least 5 cycles of platinum-based chemotherapy","Subjects who have or have had a solid tumor diagnosis and any of the following:","At least 4 months of exposure to a PARP inhibitor","Diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm"],"whoShouldSkip":["Individuals with a life expectancy of less than 6 months"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Seattle. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.173Z"},{"nctId":"NCT06300697","title":"Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project","officialTitle":"Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.\n\nThis is a mechanistic study consisting of obtaining blood and skin samples from participants at baseline. Individuals may also undergo a clinically indicated oral food challenge and have blood and skin samples collected at various times during the oral food challenge. This study will create a molecular map of the pathology of atopic dermatitis and food allergy. This information will be deployed to evaluate the hypothesis that atopic dermatitis and food allergy share unique genetic transcriptional signals in which the study team can then further analyze pathological pathways and cell types.","conditions":["Atopic Dermatitis","Food Allergy","Healthy"],"keywords":["Blood Samples","Skin Samples","Transepidermal water loss (TEWL) monitor","Allergic reaction"],"interventions":[{"type":"OTHER","name":"Data and biospecimen collection"},{"type":"OTHER","name":"Skin biopsies"},{"type":"OTHER","name":"Oral Food Challenge (OFC) procedures"}],"enrollment":200,"startDate":"2024-02-15","completionDate":"2028-03","sex":"ALL","minAge":"10 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Food allergy-only group Inclusion Criteria:\n\n* Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame confirmed by an allergist.\n* Have had skin and blood food allergy testing to the food allergen in question within the past 6 months. Meet the 80% likelihood positive predictive value threshold for allergy based on at least 1 of either the skin or blood immunoglobulin E (IgE) tests per current literature corrected for age. See protocol for more details.\n* No history of atopic dermatitis\n\nFood allergy plus atopic dermatitis group Inclusion Criteria:\n\n\\- Meet the \"food allergy only group\" inclusion criteria except this group must also have atopic dermatitis.\n\nAtopic dermatitis without food allergy Inclusion Criteria:\n\n* Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist.\n* Have no history of food allergy, past or present.\n\nControl Group Inclusion Criteria:\n\n\\- No history of food allergy or atopic dermatitis, past or present.\n\nExclusion Criteria for all groups:\n\n* People younger than age 10 or older than age 55\n* Any active cardiovascular disease, cancer, pulmonary disease except well-controlled asthma, or other condition that would preclude an OFC otherwise. Mild conditions that would not preclude an OFC are allowed (i.e., controlled hypertension or a surgically removed skin cancer that is resolved would not be exclusionary for this study, for example).\n* Any medication use that cannot be stopped temporarily for the OFC that would interfere with the OFC result. Medications in this category include antihistamines (first or second generation) within 1 week.\n* Any skin condition aside from atopic dermatitis per inclusion criteria groups that might impact the study, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes.\n* Any recent change (within 6 months) of starting or stopping a biologic medication, such as dupilumab, tezepelumab, or others that might interfere with atopic dermatitis or food allergy.\n* Any past or present history of oral immunotherapy (OIT) for any food allergen.\n* Pregnancy - females of childbearing age will be asked and self-report pregnancy status.","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bridgette Kaul","phone":"734-647-8284","email":"foodallergyclinicalresearch@med.umich.edu"}],"primaryOutcomes":["Anaphylaxis occurrence rates in each group"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Data and biospecimen collection for Atopic Dermatitis","inPlainEnglish":"This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.","whoItsFor":["Ages 10 Years to 55 Years","Food allergy-only group","Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame confirmed by an allergist","No history of atopic dermatitis","Food allergy plus atopic dermatitis group who can join:","\\- Meet the \"food allergy only group\" who can join except this group must also have atopic dermatitis","Atopic dermatitis without food allergy who can join:","Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist"],"whoShouldSkip":["People younger than age 10 or older than age 55","Any medication use that cannot be stopped temporarily for the OFC that would interfere with the OFC result. Medications in this category include antihistamines (first or second generation) within 1 week","Any skin condition aside from atopic dermatitis per who can join groups that might impact the study, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes","Any recent change (within 6 months) of starting or stopping a biologic medication, such as dupilumab, tezepelumab, or others that might interfere with atopic dermatitis or food allergy","Any past or present history of oral immunotherapy (OIT) for any food allergen","Pregnancy - females of childbearing age will be asked and self-report pregnancy status"],"whatHappens":"If you join, the listed intervention(s) are Data and biospecimen collection, Skin biopsies, or Oral Food Challenge (OFC) procedures. The registry lists allocation as randomized. This study will explore potential links between atopic dermatitis and food allergy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Ann Arbor. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.811Z"},{"nctId":"NCT06304389","title":"Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy","officialTitle":"Effect of Blue Light on Vagus Nerve Stimulation in Patients With Refractory Epilepsy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","sponsorClass":"OTHER","summary":"Vagus nerve stimulation (VNS) is an adjunctive treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response. Light, and particularly blue light, can stimulate alertness, attention and cognition through modulation of anatomical targets which are common to the vagal afferent network. This project aims at understanding how exposure to blue enriched light may influence VNS effects in patients with refractory epilepsy by exploring the modulation of a series of biomarkers of VNS action. This could possibly lead to new therapeutic strategies to increase efficacy of VNS.","conditions":["Refractory Epilepsy"],"keywords":[],"interventions":[{"type":"OTHER","name":"electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration"},{"type":"OTHER","name":"transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration"}],"enrollment":34,"startDate":"2023-07-01","completionDate":"2023-07-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPatients:\n\nVNS implanted since at least 3 months age \\>18-60 years; IQ \\>55 on Wechsler scale (normal status or mild cognitive impairment)\n\nhealthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)\n\nExclusion criteria:\n\nPatients:\n\nother medical implanted devices than VNS, ocular diseases\n\nHelthy participants:\n\nmedical implanted devices, cerebral trauma, ocular disease","locations":[{"facility":"Cliniques Universitaires Saint Luc","city":"Woluwe-Saint-Lambert","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Inci / cakiroglu","phone":"+32470612917","email":"inci.cakiroglu@uclouvain.be"}],"primaryOutcomes":["Effect of blue light on VNS biomarkers","Effect of blue light on VNS biomarkers","Effect of blue light on VNS biomarkers"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["woluwe-saint-lambert-belgium"],"enrichment":{"headline":"Not a traditional drug phase: electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration for Refractory Epilepsy","inPlainEnglish":"Vagus nerve stimulation (VNS) is an added on top of your current treatment treatment for refractory epilepsy. Although widely used, there is still a substantial number of patients with insufficient response.","whoItsFor":["Ages 18 Years to 60 Years","VNS implanted since at least 3 months age \\>18-60 years; IQ \\>55 on Wechsler scale (normal status or mild cognitive impairment)","healthy participants aged between 18 and 35 years without any medical history (neurological / psychiatric disease)"],"whoShouldSkip":["other medical implanted devices than VNS, ocular diseases","Helthy participants:","medical implanted devices, cerebral trauma, ocular disease"],"whatHappens":"If you join, the listed intervention(s) are electroencephalography, electrocardiogram, pupillometry, evoked potentials, light administration, or transcutaneous vagus nerve stimulation, electroencephalography, pupillometry, electrocardiogram, light administration. The registry lists allocation as randomized. Vagus nerve stimulation (VNS) is an added on top of your current treatment treatment for refractory epilepsy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 34 people at Woluwe-Saint-Lambert. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.906Z"},{"nctId":"NCT06307652","title":"Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function","officialTitle":"A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared With Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients With Heart Failure and Impaired Kidney Function","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.","conditions":["Heart Failure and Impaired Kidney Function"],"keywords":[],"interventions":[{"type":"DRUG","name":"balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg"},{"type":"DRUG","name":"balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg"},{"type":"DRUG","name":"dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin"}],"enrollment":3850,"startDate":"2024-04-12","completionDate":"2027-04-16","sex":"ALL","minAge":"18 Years","maxAge":"130 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Documented diagnosis of symptomatic HF (NYHA functional class II-IV)\n* Having had a recent HF event within 6 months (hospitalization or urgent visit)\n* Have a LVEF value from an assessment within the last 12 months\n* Managed with SoC therapy for HF and renal impairment according to local guidelines\n* NT-proBNP must be \\>300 pg/mL (\\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)\n* Not taking an MRA\n* An eGFR ≥ 20 to \\< 60 mL/min/1.73 m2\n* Serum/plasma potassium ≤ 5.0 mmol/L\n\nExclusion Criteria:\n\n* Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period\n* Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations\n* History of hypertrophic obstructive cardiomyopathy\n* Complex congenital heart disease or severe uncorrected primary valvular disease\n* Symptomatic bradycardia or second- or third-degree heart block without a pacemaker\n* Systolic BP 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3: testing balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg for Heart Failure and Impaired Kidney Function","inPlainEnglish":"This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to measure the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.","whoItsFor":["Ages 18 Years to 130 Years","Documented diagnosis of symptomatic HF (NYHA functional class II-IV)","Having had a recent HF event within 6 months (hospitalization or urgent visit)","Have a LVEF value from an assessment within the last 12 months","Managed with SoC therapy for HF and renal impairment according to local guidelines","NT-proBNP must be \\>300 pg/mL (\\>600 pg/mL if concomitant atrial fibrillation or atrial flutter)","An eGFR ≥ 20 to \\< 60 mL/min/1.73 m2","Serum/plasma potassium ≤ 5.0 mmol/L"],"whoShouldSkip":["Acute coronary syndrome (unstable angina or myocardial infarction), stroke or transient ischaemic attack within the previous 3 months prior to enrolment or during the screening period","Major cardiac surgery, coronary revascularisation or valvular repair or replacement, or implantation of a Cardiac resynchronisation therapy device within 3 months prior to enrolment or during the screening period, or planned to undergo any of these operations","History of hypertrophic obstructive cardiomyopathy","Complex congenital heart disease or severe uncorrected primary valvular disease","Symptomatic bradycardia or second- or third-degree heart block without a pacemaker","Systolic BP \\< 90 mmHg, or symptomatic hypotension within the past 24 hours","Primary pulmonary hypertension, chronic pulmonary embolism, severe pulmonary disease including COPD or exacerbation of COPD requiring invasive mechanical ventilation assistance within 12 months prior to enrolment"],"whatHappens":"If you join, the listed intervention(s) are balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg, balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg, or dapagliflozin 10 mg and matching placebo for balcinrenone/dapagliflozin. The registry lists allocation as randomized. This is a Phase III, international, multi-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 3,850 people at 656 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.967Z"},{"nctId":"NCT06307665","title":"Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma","officialTitle":"A Randomized, Double-blind, Multicenter, Parallel-group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered as Needed in Participants 12 to < 18 Years of Age With Asthma (ACADIA)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.","conditions":["Asthma"],"keywords":["Fast-acting β2-agonist","Metered-Dose Inhaler (MDI)","Bronchodilatory","Inhaled corticosteroids","Anti-inflammatory","Rescue Therapy"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"BDA MDI"},{"type":"COMBINATION_PRODUCT","name":"AS MDI"}],"enrollment":440,"startDate":"2024-05-20","completionDate":"2027-10-13","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed clinical diagnosis of asthma at least 12 months.\n* Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month\n\n  1. Low-to-high-dose Inhaled corticosteroid(s) (ICS)\n  2. Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline\n* Receiving inhaled short-acting β2-agonist (SABA) as needed.\n* A documented history of at least one severe asthma exacerbation within 12 months.\n* Use of Sponsor-provided albuterol sulfate inhalation aerosol medication.\n* Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited.\n* Able to perform acceptable and reproducible peak expiratory flow (PEF) measurements as assessed by the investigator.\n* Participants must adhere to protocol specific contraception methods.\n* Negative urine pregnancy test for participants of childbearing potential.\n* Have a BMI \\< 40 kg/ m\\^2.\n* Capable of giving assent (signing the assent form) to participate in the study which includes compliance with the requirements and restrictions. The caregiver of the patient must be capable of giving written informed consent for the patient's participation in the study. Consent and assent forms must be completed prior to any study-specific procedures.\n\nExclusion Criteria:\n\n* Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).\n* Experienced \\> 3 severe asthma exacerbations within 12 months before screening.\n* Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening.\n* Upper respiratory infection involving antibiotic treatment not resolved.\n* Current smokers, former smokers with \\> 10 pack-years history, or former smokers who stopped smoking \\< 6 months (including all forms of tobacco, e-cigarettes \\[vaping\\], and marijuana).\n* Other significant lung disease, including regular or occasional use of oxygen.\n* Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders.\n* Cancer not in complete remission for at least 5 years.\n* History or hospitalization for psychiatric disorder or attempted suicide within one year.\n* Significant abuse of alcohol or drugs, in the opinion of the investigator.\n* Oral corticosteroid(s) (OCS)/SCS use (any dose and any indication) within 4 weeks before Visit 1 or chronic use of OCS/SCS (≥ 3 weeks use in 3 months prior to Visit 1).\n* Use of any oral SABAs within one month.\n* Having a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients.","locations":[{"facility":"Research Site","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research 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3: BDA MDI for Asthma","inPlainEnglish":"This study wants to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.","whoItsFor":["Ages 12 Years to 17 Years","Confirmed clinical diagnosis of asthma at least 12 months","Receiving one of the following scheduled asthma maintenance therapies for at least 3 months with stable dosing for at least the last one month","Low-to-high-dose Inhaled corticosteroid(s) (ICS)","Low-to-high-dose ICS or ICS/long-acting β2-agonist (LABA) with or without one additional maintenance therapy from the following: leukotriene receptor antagonist (LTRA), long-acting muscarinic antagonist (LAMA), or theophylline","Receiving inhaled short-acting β2-agonist (SABA) as needed","A documented history of at least one severe asthma exacerbation within 12 months","Use of Sponsor-provided albuterol sulfate inhalation aerosol medication"],"whoShouldSkip":["Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)","Experienced \\> 3 severe asthma exacerbations within 12 months before screening","Completed treatment for lower respiratory infection and severe asthma exacerbation with SCS within 4 weeks of screening","Upper respiratory infection involving antibiotic treatment not resolved","Current smokers, former smokers with \\> 10 pack-years history, or former smokers who stopped smoking \\< 6 months (including all forms of tobacco, e-cigarettes \\[vaping\\], and marijuana)","Other significant lung disease, including regular or occasional use of oxygen","Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, or gastrointestinal disorders"],"whatHappens":"If you join, the listed intervention(s) are BDA MDI, or AS MDI. The registry lists allocation as randomized. This study wants to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 440 people at 123 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.341Z"},{"nctId":"NCT06308588","title":"Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","officialTitle":"Phase I/II Study of the Combination of Blinatumomab and Asciminib in Patients With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.","conditions":["Philadelphia Chromosome-Positive","Acute Lymphoblastic Leukemia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Blinatumomab"},{"type":"DRUG","name":"Asciminib"}],"enrollment":40,"startDate":"2024-08-05","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of one of the following:\n\n   a) Participants ≥18 years of age with previously untreated or minimally pretreated Ph-positive ALL who are not suitable candidates for intensive chemotherapy. Participants who have received no more than one or two courses of chemotherapy with or without other TKIs are considered minimally pretreated and still eligible if they have persistently detectable MRD.\n\n   i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML\n2. Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \\<18 years\n3. Weight ≥40kg\n4. Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):\n\n   1. Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome\n   2. Alanine aminotransferase (ALT) ≤ 3 x ULN, OR\n   3. Aspartate aminotransferase (AST) ≤ 3 x ULN\n5. Adequate renal function defined as:\n\n   a) Creatinine clearance ≥30 mL/min\n6. Adequate pancreatic function as defined by the following criteria:\n\n   a) Serum lipase and amylase \\< 1.5 x ULN\n7. Adequate cardiac function as assessed clinically by history and physical examination.\n8. For females of childbearing potential, a negative urine pregnancy test must be documented\n9. Willingness to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study participation. For women of child-bearing potential, adequate methods of contraception include: complete abstinence, hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), intrauterine device (IUD), tubal Ligation or hysterectomy, subject/partner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide\n10. Ability to understand and the willingness to sign a written informed consent document.\n11. Signed informed consent\n\nExclusion Criteria:\n\n1. Active serious infection not controlled by oral or intravenous antibiotics.\n2. Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year.\n3. Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria.\n4. Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist\n5. History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. (Participants with active CNS leukemia will NOT be excluded)\n6. Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Cytarabine 2 g/m2 (or alternative) for cytoreduction is permitted.\n7. Pregnant and lactating women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to practice methods of contraception. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control.","locations":[{"facility":"Montefiore Einstein Comprehensive Cancer Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicholas Short, MD","phone":"(713) 563-4485","email":"nshort@mdanderson.org"}],"primaryOutcomes":["Safety and adverse events (AEs)"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["the-bronx-new-york","houston-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Blinatumomab for Philadelphia Chromosome-Positive","inPlainEnglish":"To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.","whoItsFor":["Ages 18 Years to any","Diagnosis of one of the following:","i. If they are in morphologic remission at enrollment, they are evaluable only MRD responses, RFS and OS b) Participants ≥ 12 years of age with relapsed/refractory Ph-positive ALL or with previously treated lymphoid blast phase CML","Performance status ≤2 (ECOG Scale) if age ≥18 years or Lansky ≥50 if age \\<18 years","Adequate liver function as defined by the following criteria (unless the increased values are judged to be leukemia disease related):","Total serum bilirubin ≤ 2 x upper limit of normal (ULN), unless due to Gilbert's syndrome","Alanine aminotransferase (ALT) ≤ 3 x ULN, OR","Aspartate aminotransferase (AST) ≤ 3 x ULN"],"whoShouldSkip":["Active serious infection not controlled by oral or intravenous antibiotics","Active secondary malignancy other than skin cancer (e.g., basal cell carcinoma or squamous cell carcinoma) that in the investigator's opinion will shorten survival to less than 1 year","Active Grade III-V cardiac failure as defined by the New York Heart Association Criteria","Prolonged QTc interval on pre-entry electrocardiogram (\\> 470 msec) unless corrected after electrolyte replacement or approved by cardiologist"],"whatHappens":"If you join, the listed intervention(s) are Blinatumomab, or Asciminib. The registry lists allocation as na. To learn if the combination of blinatumomab and asciminib can help to control Ph+ ALL.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.815Z"},{"nctId":"NCT06310551","title":"First Time in Human Study of Long Acting VH4524184 Formulations","officialTitle":"A Phase 1 Double-Blind (Sponsor-unblinded), Placebo-Controlled Randomized, Single Ascending Dose and Multiple Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Parenterally Administered VH4524184 in Healthy Adults","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"ViiV Healthcare","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.","conditions":["HIV Infections"],"keywords":["Safety","Tolerability","Parenteral","First Time in Human","Pharmacokinetics","Ascending Dose","Multiple Dose","Healthy Adults"],"interventions":[{"type":"DRUG","name":"Oral VH4524184"},{"type":"DRUG","name":"VH4524184 Formulation A SC"},{"type":"DRUG","name":"Placebo Formulation A SC"},{"type":"DRUG","name":"rHuPH20"},{"type":"DRUG","name":"VH4524184 Formulation B SC"},{"type":"DRUG","name":"Placebo Formulation B SC"},{"type":"DRUG","name":"VH4524184 Formulation A IM"},{"type":"DRUG","name":"Placebo Formulation A IM"},{"type":"DRUG","name":"VH4524184 Formulation B IM"},{"type":"DRUG","name":"Placebo Formulation B IM"}],"enrollment":348,"startDate":"2024-03-21","completionDate":"2029-05-28","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAge\n\n-Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.\n\nType of Participant and Characteristics\n\n* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.\n* Participants who are able to understand and comply with protocol requirements and timetables, instructions, and protocol-stated restrictions.\n\nWeight -Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \\>32.0 to 37.0 kg/m\\^2 (inclusive).\n\nSex and Contraceptive/Barrier Requirements\n\n* Male or female\n\n  1. Male Participants: No restrictions for male participants\n  2. Participants of female sex assigned at birth:\n\n     * A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception.\n     * A participant of non-childbearing potential (PONCBP) is eligible to participate if all other eligibility criteria are met.\n\n     Informed Consent\n* Capable of providing signed informed consent.\n\nExclusion Criteria:\n\nMedical Conditions\n\n* History or presence of clinical condition or disorder that could be capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study drug, interfering with the interpretation of data or would make the participant unsuitable for the study; unable to comply with dosing requirements; or unable to comply with study visits.\n* Clinically significant abnormal blood pressure as determined by the investigator.\n* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Breast cancer within the past 10 years.\n* Current or chronic history of liver disease or known hepatic or biliary abnormalities.\n* Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome.\n* Underlying skin disease or disorder that would interfere with the administration of study product and/or assessment of injection site reactions.\n* Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of /sensitivity to any of the study interventions including hyaluronidases.\n* Current or anticipated need for chronic anti-coagulation except for the use of low dose acetylsalicylic acid (≤325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease.\n* History of seizure.\n* Any known or suspected pre-existing psychiatric condition, including depression, anxiety and insomnia/sleep disturbances, at the discretion of the investigator.\n* Any positive (abnormal) response confirmed by the investigator or clinician (or qualified designee) administered C-SSRS at screening.\n* Insufficient muscle mass (gluteus medius or thigh) to support IM dose administration in the opinion of the investigator.\n* Presence of tattoos, implants or skin piercings that may interfere with the administration of study product and/or assessment of ISRs, if they occur.\n* History of or on-going high-risk behaviors that may put the participant at increased risk for HIV acquisition in the opinion of the investigator. This includes participants in HIV discordant relationships, or men who report current or prior unprotected anal sex with other men and those reporting prior or current injecting drug use.\n\nPrior/Concomitant Therapy\n\n* Past or intended use of over-the-counter or prescription medication within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to dosing and for the duration of the study.\n* Receipt of any live vaccine(s) within 28 days prior to screening or 14 days before or after scheduled SC or IM dosing.\n\nPrior/Concurrent Clinical Study Experience\n\n* Exposure to more than 4 new investigational products (including long-acting investigational products) within 12 months prior to the first dosing day.\n* Current enrollment or past participation in another investigational study in which an investigational intervention was administered within the last 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product before signing of consent (OR screening) any other clinical study.\n* Participation in the study would result in loss of blood in excess of 500 mL over a 56-day period.\n* Current enrollment or past participation in this clinical study, with the exception of participants who previously completed the Oral Lead In (OLI) but for operational or logistic reasons did not progress to CRU admission and receipt of injectable suspension for injection (SFI) or powder for suspension for injection (PFS) study medication or placebo, or prior participation in study 218803.\n\nDiagnostic Assessments\n\n* eGFR \\<60 mL/min or serum creatinine \\>1.1 x ULN.\n* Hemoglobin \\<12.5 g/dL for men and \\<11 g/dL for women\n* ALT or AST \\> upper limit of normal (ULN).\n* Total bilirubin \\>1.5xULN.\n* Any significant arrhythmia or ECG finding.\n* Exclusion criteria for Screening ECG - a single repeat is allowed for eligibility determination.\n* Presence of HBsAg and/or anti-HBc at Screening or within 3 months prior to first dose of study intervention.\n* Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.\n* Positive pre-study drug/alcohol screen.\n* Positive HIV antibody test.\n\nOther Exclusions\n\n* Regular alcohol consumption within 6 months prior to the study defined as: An average weekly intake of \\>14 units for males or \\>7 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (\\~240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n* Regular use of known drugs of abuse.\n* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening and at admission.\n* Sensitivity to the study drug, or components thereof, or other drug or other allergy that, in the opinion of the investigator or Sponsor Medical Monitor, contraindicates participation in the study.\n* Fasting glucose \\>125 mg/dL (6.95 mmol/L) or receiving treatment for elevated blood glucose.\n* Triglycerides \\>500 mg/dL (5.7 mmol/L) or receiving treatment for dyslipidemia.","locations":[{"facility":"GSK Investigational Site","city":"Lenexa","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Percentage of participants reporting adverse events (AEs) and related AEs","Percentage of participants with AEs by severity","Percentage of participants discontinuing the treatment due to AEs","Change from baseline in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase parameters","Change from baseline in total bilirubin parameters","Change from baseline in international normalized ratio (INR) parameters","Maximum toxicity grade increase from baseline in ALT, AST and alkaline phosphatase","Maximum toxicity grade increase from baseline in total bilirubin","Maximum toxicity grade increase from baseline in INR","Percentage of participants reporting injection site reaction (ISR) AEs","Duration of injection site reaction AEs","Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinity time (AUC[0-inf]) of LAI VH4524184 following single dose administration","Area under the plasma drug concentration-time curve from zero (pre-dose) to the end of the dosing interval at steady state (AUC[0-t]) of LAI VH4524184 following multiple dose administration","Maximum observed plasma drug concentration (Cmax) of LAI VH4524184 following single dose administration","Cmax of LAI VH4524184 following multiple dose administration","Time to maximum observed plasma drug concentration (Tmax) of LAI VH4524184 following single dose administration","Tmax of LAI VH4524184 following multiple dose administration","Apparent terminal half-life (t1/2) of LAI VH4524184 following single dose administration","t1/2 of LAI VH4524184 following multiple dose administration"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["lenexa-kansas","las-vegas-nevada","austin-texas","san-antonio-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 1: testing Oral VH4524184 for HIV Infections","inPlainEnglish":"This study wants to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.","whoItsFor":["Ages 18 Years to 55 Years","Type of Participant and Characteristics","Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring","Weight -Body weight ≥50.0 kg (110 lbs) for men and ≥45.0 kg (99 lbs) for women and body mass index within the range 18.5 to 32.0 kg/m\\^2 (inclusive) for all cohorts except B19. For Cohort B19, body mass index within the range \\>32.0 to 37.0 kg/m\\^2 (inclusive)","Sex and Contraceptive/Barrier Requirements","Male Participants: No restrictions for male participants","Participants of female sex assigned at birth:","A participant of childbearing potential (POCBP) (female sex assigned at birth) is eligible to participate as long as the participant is not pregnant, breastfeeding and utilizes a highly effective method of contraception"],"whoShouldSkip":["Clinically significant abnormal blood pressure as determined by the investigator","Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years","Breast cancer within the past 10 years","Current or chronic history of liver disease or known hepatic or biliary abnormalities","Medical history of cardiac arrhythmias or cardiac disease or a family and personal history of long QT syndrome","Underlying skin disease or disorder that would interfere with the administration of study product and/or assessment of injection site reactions","Clinically significant history of drug hypersensitivity, delayed-type hypersensitivity or severe hypersensitivity reactions, as well as history of /sensitivity to any of the study interventions including hyaluronidases"],"whatHappens":"If you join, the listed intervention(s) are Oral VH4524184, VH4524184 Formulation A SC, or Placebo Formulation A SC. The registry lists allocation as randomized. This study wants to identify 1 or more doses of parenterally administered VH4524184 that are safe, well tolerated and yield a PK drug exposure profile necessary to deliver a long-acting antiretroviral therapy for the treatment of HIV-1 infection.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 348 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.533Z"},{"nctId":"NCT06311214","title":"Personalized Antibody-Drug Conjugate Therapy Based on RNA and Protein Testing for the Treatment of Advanced or Metastatic Solid Tumors (The ADC MATCH Screening and Treatment Trial)","officialTitle":"Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient. ADCs such as sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan are monoclonal antibodies attached to biologically active drugs and are a form of targeted therapy. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab attaches to a protein called Trop-2 on the surface of tumor cells and delivers govitecan to kill them. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. Trastuzumab deruxtecan is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Personalized treatment with sacituzumab govitecan, enfortumab vedotin, or trastuzumab deruxtecan may be an effective treatment option for patients with advanced or metastatic solid tumors that screen positive for high expression of Trop-2, nectin-4, or HER2, respectively.","conditions":["Advanced Malignant Solid Neoplasm","Metastatic Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"OTHER","name":"Electronic Health Record Review"},{"type":"DRUG","name":"Enfortumab Vedotin"},{"type":"OTHER","name":"Immunohistochemistry Staining Method"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"BIOLOGICAL","name":"Sacituzumab Govitecan"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":500,"startDate":"2025-03-18","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* SCREENING PROTOCOL INCLUSION CRITERIA:\n* Patients must have histologically confirmed solid tumor requiring therapy and meet one of the following criteria:\n\n  * Patients must have disease not amenable to curative-intent therapy AND\n  * Patients who have had disease progression after treatment with all available therapies for their disease that are known to confer benefit or are intolerant to such treatment will be eligible, if other eligibility criteria are met. If the patient is currently receiving therapy without progression, the clinician must have assessed that the current therapy is no longer benefitting the patient, or that the patient is not tolerating the therapy. Patients can be screened on ADC MATCH if they have had three or fewer-lines of chemotherapy in the advanced/metastatic setting and are expected to need a treatment change within 6 months, and ADC MATCH is felt to be appropriate next line therapy AND\n  * Patients with disease for which no standard treatment exists that has been shown to confer benefit OR\n  * Patients who are willing to forego standard therapies known to confer benefit\n\n    * NOTE: Patients can be on therapy at the time of initiating the Screening Protocol if the patient is interested in treatment on ADC MATCH upon progression, and the physician deems this appropriate\n* Patient must have undergone RNA testing in a Clinical Laboratory Improvement Act (CLIA) environment or must submit archival tissue to determine RNA overexpression of ADC TOIs by the TARGET Assay. Patients who have high TOI RNA expression will have confirmation of TOI expression by CLIA IHC assay at MD Anderson Cancer Center (MDACC). Only patients with confirmed TOI protein expression will be eligible for assignment to a treatment cohort. Retrospective confirmation in another central laboratory may also be performed. (A proportion of specimens in patients who are negative for RNA overexpression may be tested to better understand the concordance between the TARGET Assay and immunohistochemistry (IHC) assays, as funding and tissue availability allows. Only patients with RNA and protein expression with be eligible for treatment on ADC MATCH)\n* Patients must be willing to undergo mandatory pre-treatment and on-treatment tumor biopsies. Patients who do not consent to these research biopsies will not be eligible for prescreening. Patients who have screened and consented to a treatment cohort but are found to have disease that cannot be safely biopsied will be eligible for treatment provided all other eligibility criteria are met\n* Patients must have measurable disease. (Per radiologic imaging within the past 2 months).\n\n  * Note: Patients with active metastatic disease that is not measurable but who are expected to be eligible for a Treatment Cohort can be screened after discussion with the primary investigator (PI)\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of the Cancer Therapy Evaluation Program (CTEP) investigational new drug (IND) agents to be used in the study in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group performance status of 0-2 based on most recent assessment (Karnofsky ≥ 50%)\n* No history of transfusion dependence\n* No history of persistent bone marrow suppression (absolute neutrophil count ≥ 1,500/mL and platelets ≥ 100,000/mL not attributable to active therapy; patients currently on bone marrow suppressive therapy can undergo assessment for the screening protocol but cannot be treated on any of the treatment cohorts unless bone marrow suppression is reversed off the suppressive therapy) (New testing will not be performed for the screening protocol, but rather existing labs will be assessed to assess eligibility)\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤ 3 × ULN (New testing will not be performed for the screening protocol, but rather existing labs will be assessed to assess eligibility)\n* Aspartate transaminase (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine transaminase (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 2.5 × institutional ULN. Transaminases up to 5 × ULN in the presence of liver metastases are not allowed to initiate the screening protocol but are allowed for the treatment cohorts (New testing will not be performed for the screening protocol, but rather existing labs will be assessed to assess eligibility)\n* Creatinine ≤ institutional ULN OR glomerular filtration rate ≥ 60 mL/min/1.73 m\\^2 for patients with creatinine levels above institutional normal unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m\\^2 (New testing will not be performed for the screening protocol, but rather existing labs will be assessed to assess eligibility)\n* Patients must have albumin ≥ 3 g/dL\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational agents are eligible for this study\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this study, patients should be class 2B or better\n* Women of childbearing potential must not be known to be pregnant. Pregnancy testing is not required\n* Ability to understand and the willingness to sign a written informed consent document\n* ADDITIONAL INCLUSION CRITERIA FOR TREATMENT COHORTS:\n* Women of childbearing potential must have a negative serum pregnancy test result at treatment cohort screening\n* The effects of the study drugs on the developing human fetus are unknown. For this reason and because investigational agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 6 months after completion of study drug administration (unless otherwise indicated in the eligibility section \\[Section 2\\] of the Treatment Cohort protocols). Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after completion of study drug administration\n* Hemoglobin \\> 9.0 g/dL\n* Leukocytes ≥ 3000/mL\n* Absolute neutrophil count ≥ 1,500/mL\n* Platelets ≥ 100,000/mL\n* Patient must be willing to sign the relevant treatment cohort consent form\n* Patients should have received no more than 3 prior lines of chemotherapy in the advanced/metastatic setting. Therapy given for only 1 cycle and discontinued because of toxicity in the absence of disease progression will not be counted as a line of therapy. Radio-sensitizing chemotherapy, if only given with radiation therapy will not be considered a line of therapy\n* Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this study\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* COHORT A INCLUSION CRITERIA:\n* Patients must fulfill all the eligibility criteria outlined in the ADC MATCH screening protocol at the time of treatment cohort A registration\n* Patient must have high Trop-2 protein expression (IHC 2+ or 3+) as determined by the MD Anderson Cancer Center Clinical Laboratory Improvement Amendments IHC assay\n\n  * Patients who have Trop-2 IHC testing without RNA testing or who have Trop-2 IHC 2 or 3+ expression but do not have Trop-2 expression detected on RNA testing will not be eligible for the trial.\n  * Patients who have Trop-2 RNA expression and Trop-2 IHC 2+ or 3+ on another Trop-2 IHC test will undergo Trop-2 testing with the integral MDACC IHC assay\n  * Patients who already have RNA expression testing demonstrating Trop-2 RNA expression as well as IHC testing on the MDACC CLIA lab platform will be eligible for enrollment after review of results by the Precision Oncology Decision Support team without having to repeat Trop-2 IHC results as part of pre-screening. Patients who have had TROP2 2+ testing result performed outside of MDACC will have to undergo MDACC TROP2 IHC analysis before enrollment\n* COHORT B INCLUSION CRITERIA:\n* Patients must fulfill all the eligibility criteria outlined in the ADC MATCH screening protocol at the time of treatment cohort B registration\n* Patient must have high Nectin-4 protein expression (IHC 2+ or 3+) as determined by the MD Anderson Cancer Center Clinical Laboratory Improvement Amendments IHC assay\n* COHORT C INCLUSION CRITERIA:\n* Patients must fulfill all the eligibility criteria outlined in the ADC MATCH screening protocol at the time of treatment cohort C registration\n* Patient must have HER2 protein expression (IHC 2+ or 3+) as determined by the MD Anderson Cancer Center (MDACC) IHC assay\n\n  * Patients who have HER2 IHC testing without RNA testing or who have HER2 IHC 2 or 3+ expression but do not have HER2 expression detected on RNA testing will not be eligible for the trial\n  * Patients who have HER2 RNA expression and HER2 IHC 3+ or 2+ on another HER2 IHC test will undergo HER2 testing with the integral MDACC IHC assay\n  * Patients who already have RNA expression testing demonstrating HER2 RNA expression as well as IHC testing on the MDACC CLIA lab platform will be eligible for enrollment after review of results by the Precision Oncology Decision Support team without having to repeat HER2 IHC results as part of pre-screening. Patients who have had HER2 2+ testing result performed outside of MDACC will have to undergo MDACC HER2 IHC analysis before enrollment\n* Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months after completion of study drug administration. Women should not breastfeed during the study treatment period and for 7 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to study entry, for the duration of study participation, and for 4 months after completion of study drug administration. Female patients must not donate, or retrieve for their own use, ova from the time of screening throughout the study treatment period and for at least 7 months after the final study drug administration. Female patients may wish to consider preservation of ova prior to enrollment in the study. Male patients should refrain from freezing or donating sperm during the study and for 6 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in the study\n* LVEF ≥50% within 28 days before enrollment\n\nExclusion Criteria:\n\n* SCREENING PROTOCOL EXCLUSION CRITERIA:\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease. Patients with treated brain metastases are eligible if follow-up brain imaging 4 weeks after central nervous system-directed therapy shows no evidence of progression\n* Clinically significant cardiovascular condition including: (1) history of congestive heart failure (New York Health Association class \\> 2), (2) any history of unstable angina, (3) myocardial infraction within the past 12 months, or (4) any history of supraventricular arrhythmia or ventricular arrhythmia requiring treatment or intervention within the past 12 months\n* History or presence of abnormal electrocardiogram (ECG) that, in the investigator's opinion, is clinically meaningful\n* Active or chronic corneal disorder including, but not limited to, Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment), history of corneal transplantation, active herpetic keratitis, and/or active ocular conditions requiring ongoing treatment/monitoring such as wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, presence of papilledema, and acquired monocular vision\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to the ADCs used in the study\n* History of interstitial lung disease or pneumonitis requiring steroid therapy\n* Grade 2 or greater peripheral neuropathy\n* Patients requiring the use of full dose coumarin-derivative anticoagulants such as warfarin. Low molecular weight heparin is permitted for prophylactic or therapeutic use. Factor X inhibitors are permitted\n\n  * Note: Warfarin may not be started while enrolled in the treatment cohorts. Stopping the anticoagulation for biopsy should be per site standard operating practice\n* Pregnant women are excluded from the study because the study drugs are investigational or approved agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with any of the study drugs, breastfeeding should be discontinued if the mother is treated with any of the study drug\n* ADDITIONAL EXCLUSION CRITERIA FOR TREATMENT COHORTS:\n* Patients must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery; 4 weeks from antibody-based therapy; 2 weeks or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); and 4 weeks from radiation therapy. Patients should have received no more than 3 prior lines of chemotherapy. Testosterone suppression as supportive treatment for castration-resistant prostate cancer and ovarian suppression in premenopausal patients with breast cancer that have supportive treatment and not anticancer treatment role (with luteinizing hormone-releasing hormone analogs) will be allowed if the patients were on these supportive treatments before starting the study. Use of bone-modifying medications (bisphosphonates or denosumab) will be allowed. Palliative radiotherapy of non-target lesions is permitted, but presence of new or worsening metastases will be considered progressive disease. If there is clear evidence of clinical benefit, study treatment may be continued 2 weeks after completion of palliative radiotherapy to lesions that are non-target lesions. Patients can be on therapy during treatment cohort screening\n* Patients who are currently receiving any other investigational agent(s)\n* Received systemic therapy with corticosteroids at \\> 20 mg/day prednisone or equivalent within 1 week prior to cycle 1 day 1\n* Patients who have not recovered from AEs due to prior anticancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* When the corrected QT interval (QTc) by Fridericia's formula is \\< 120 ms, \\> 450 ms in males and \\> 470 ms in females. When the QTc by Rautaharju's formula is ≥ 120 ms, \\> 450 ms in males and \\> 470 ms in females\n* Uncontrolled infection requiring intravenous antibiotic, antiviral, or antifungal use\n* Received a live, attenuated vaccine within 30 days prior to cycle 1 day 1. Enrolled patients should not receive live vaccine during the study. Non-live COVID vaccines will be allowed on study, but it is recommended to avoid their use during the first treatment cycle (from 3 days prior to cycle 1 day 1 through cycle 2 day 3)\n* Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations\n* COHORT A EXCLUSION CRITERIA:\n* Patients with histologically documented advanced colorectal cancer, urothelial cancer, head and neck cancer (Note: exceptions include patients with adenoid cystic cancer, salivary gland cancer, thyroid cancer, and parathyroid cancer, who are eligible), triple negative breast cancer (TNBC), HR-positive breast cancer, HER2-positive breast cancer, small cell lung cancer, NSCLC, and endometrial cancer\n\n  * Note: Patients with cancer of unknown primary are allowed\n* Patients who have received growth factor support within 2 weeks of study treatment initiation\n* Coadministration of sacituzumab govitecan-hziy(IMMU-132) with inhibitors of UGT1A1 may increase systemic exposure to the active metabolite, SN-38. UGT1A1 inhibitors should not be administered concomitantly with sacituzumab govitecan-hziy (IMMU-132) unless there are no therapeutic alternatives\n* Prior topoisomerase 1 inhibitor treatment\n* Prior treatment with a Trop-2-targeting ADC\n* Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or gastrointestinal (GI) perforation within 6 months of treatment cohort A registration\n* COHORT B EXCLUSION CRITERIA:\n* Patients with histologically documented advanced urothelial cancer, head and neck cancer (to include salivary gland cancer and adenoid cystic cancer), breast cancer, lung cancer, gastric cancer, gastroesophageal junction cancer, esophageal cancer, prostate cancer, or penile cancer\n\n  * Note: Patients with cancer of unknown primary are allowed\n* Concomitant use of strong inhibitors or strong inducers of cytochrome P450 (CYP)3A4. Washout period is 2 weeks prior to study treatment initiation\n* History of uncontrolled diabetes mellitus within 3 months before the first dose of study treatment. Uncontrolled diabetes mellitus is defined as hemoglobin A1c ≥ 8% or hemoglobin A1c between 7 and \\< 8% with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained\n* Known active keratitis or corneal ulcerations. Patients with superficial punctate keratitis are allowed if the disorder is being adequately treated\n* Known hypersensitivity to enfortumab vedotin or to any excipient in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20), or known hypersensitivity to biopharmaceutical produced in Chinese hamster ovary cells\n* Prior treatment with an ADC with vedotin payload\n* COHORT C EXCLUSION CRITERIA:\n* Patients with histologically documented advanced breast cancer, non-small cell lung cancer (NSCLC), colorectal carcinoma (CRC), gastric cancer, or gastroesophageal junction (GEJ) cancer\n\n  * Note: Patients with cancer of unknown primary are allowed\n* Previous treatment with topoisomerase I inhibitors as a free form or as other formulations\n* Prior","locations":[{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health System - Encinitas","city":"Encinitas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Medical Center - Hillcrest","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center-Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health Cancer Institute - Gainesville","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky/Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Medical Center Jefferson","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at Saint Peters Hospital","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at West County Hospital","city":"Creve Coeur","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center-South County","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at Christian Hospital","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt Breast Center at One Hundred Oaks","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University/Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - Eastpark Medical Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - University Hospital","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Frequency of high protein expression in patients with high ribonucleic acid (RNA) expression of each antibody-drug conjugate target (screening protocol)","Objective response rate (treatment cohorts)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["duarte-california","encinitas-california","irvine-california","la-jolla-california","orange-california","san-diego-california","new-haven-connecticut","trumbull-connecticut","gainesville-florida","chicago-illinois","lexington-kentucky","new-orleans-louisiana","boston-massachusetts","city-of-saint-peters-missouri","creve-coeur-missouri","st-louis-missouri","new-york-new-york","columbus-ohio","oklahoma-city-oklahoma","nashville-tennessee","houston-texas","charlottesville-virginia","richmond-virginia","madison-wisconsin"],"enrichment":{"headline":"Phase 2: testing Enfortumab Vedotin for Advanced Malignant Solid Neoplasm","inPlainEnglish":"This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic). Precision medicine is a form of medicine that uses information about a person's genes, proteins, and environment to prevent, diagnose, or treat disease in a way that is tailored to the patient.","whoItsFor":["Ages 18 Years to any","SCREENING PROTOCOL who can join:","Patients must have histologically confirmed solid tumor requiring therapy and meet one of the following criteria:","Patients must have disease not amenable to curative-intent therapy AND","Patients with disease for which no standard treatment exists that has been shown to confer benefit OR","Patients who are willing to forego standard therapies known to confer benefit","NOTE: Patients can be on therapy at the time of initiating the Screening Protocol if the patient is interested in treatment on ADC MATCH upon progression, and the physician deems this appropriate","Patients must have measurable disease. (Per radiologic imaging within the past 2 months)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase II ADC MATCH screening and multi-sub-study treatment trial is evaluating whether biomarker-directed treatment with one of three antibody-drug conjugates (ADCs) (sacituzumab govitecan, enfortumab vedotin, and trastuzumab deruxtecan) works in treating patients with solid tumor cancers that have high expression of the Trop-2, nectin-4, or HER2 proteins and that may have spread from where they first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced) or to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 500 people at 29 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.357Z"},{"nctId":"NCT06311682","title":"A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis","officialTitle":"A Phase 3 Multi-center Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children (Age 2 to <12 Years) and Infants (Age 6 Months to <2 Years) With Moderate-to-severe Atopic Dermatitis. The Trial is Randomized, Double-blind, Placebo-controlled, and Parallel-group for Children (Age 2 to <12 Years) and Open-label and Single-group for Infants (Age 6 Months to <2 Years)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"LEO Pharma","sponsorClass":"INDUSTRY","summary":"The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \\[SC\\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone.\n\nThe study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial.\n\nThe children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tralokinumab + TCS"},{"type":"DRUG","name":"Placebo + TCS"}],"enrollment":195,"startDate":"2024-06-10","completionDate":"2026-10-16","sex":"ALL","minAge":"6 Months","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 6 months to \\<12 years at screening.\n* Body weight ≥9 kg at screening.\n* Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.\n* History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \\<6 years at screening.\n* Documented inadequate response to mid-strength TCS within 6 months before the screening visit.\n* AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD.\n* An EASI score of ≥16 at screening and baseline.\n* An IGA score of ≥3 at screening and baseline.\n* A Child Worst Itch NRS average score of ≥4 (subjects aged ≥6 years at screening) or a Scratch ObsRO average score of ≥4 (subjects aged \\<6 years at screening) during the week prior to baseline.\n\nExclusion Criteria:\n\n* Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline.\n* Treatment with bleach baths within 1 week prior to baseline.\n* Treatment with the immunomodulatory medications systemic immunosuppressive/immunomodulating drugs (e.g. methotrexate, cyclosporine, azathioprine, mycophenolate mofetil, Janus kinase inhibitors) and systemic corticosteroids (excludes inhaled, ophthalmic, or intranasal delivery) within 4 weeks prior to baseline.\n* Use of tanning beds or phototherapy within 4 weeks prior to baseline.\n* Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit.\n* Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis.\n* Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit.\n* History of past or current hepatitis B or C including a positive hepatitis B or C test at screening.","locations":[{"facility":"Leo Pharma Investigational site","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"North Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"San Diego","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Waterford","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Brussels","state":"","country":"Belgium","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Ghent","state":"","country":"Belgium","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Leuven","state":"","country":"Belgium","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Liège","state":"","country":"Belgium","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Burlington","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Calgary","state":"","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Edmonton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Hamilton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Niagara Falls","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Saskatoon","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Windsor","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Winnipeg","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Rijeka","state":"","country":"Croatia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Zagreb","state":"","country":"Croatia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Buxtehude","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Dresden","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Mainz","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Osnabrück","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Tübingen","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Wuppertal","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Cork","state":"","country":"Ireland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Crumlin","state":"","country":"Ireland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Ancona","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Brescia","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Padova","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Roma","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Rome","state":"","country":"Italy","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Utrecht","state":"","country":"Netherlands","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Gdansk","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Krakow","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Lodz","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Ostrowiec Świętokrzyski","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Rzeszów","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Tarnów","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Warsaw","state":"","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Brasov","state":"","country":"Romania","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Iași","state":"","country":"Romania","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Ansan-si","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Gwangju","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Seoul","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Alicante","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Madrid","state":"","country":"Spain","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Valencia","state":"","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Lincoln","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Sheffield","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leo Pharma Investigational site","city":"Southampton","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Disclosure","phone":"+45 4494 5888","email":"disclosure@leo-pharma.com"}],"primaryOutcomes":["Investigator's Global Assessment for atopic dermatitis (IGA 0/1) score of 0 (clear) or 1 (almost clear) in subjects aged 2 to <12 years at screening.","Having at least 75% reduction in Eczema Area and Severity Index (EASI) score in subjects aged 2 to <12 years at screening."],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","north-little-rock-arkansas","palo-alto-california","sacramento-california","san-diego-california","jacksonville-florida","miami-florida","tampa-florida","macon-georgia","waterford-michigan","tulsa-oklahoma","portland-oregon","charleston-south-carolina","norfolk-virginia","brussels-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","burlington-canada","calgary-canada","edmonton-canada","hamilton-canada","niagara-falls-canada","saskatoon-canada","windsor-canada","winnipeg-canada","rijeka-croatia","zagreb-croatia","buxtehude-germany","dresden-germany","mainz-germany","osnabr-ck-germany","t-bingen-germany","wuppertal-germany","cork-ireland","crumlin-ireland","ancona-italy","brescia-italy","padova-italy","roma-italy","rome-italy","utrecht-netherlands","gdansk-poland","krakow-poland","lodz-poland","ostrowiec-wi-tokrzyski-poland","rzesz-w-poland","tarn-w-poland","warsaw-poland","brasov-romania","ia-i-romania","ansan-si-south-korea","gwangju-south-korea","seoul-south-korea","alicante-spain","madrid-spain","valencia-spain","lincoln-united-kingdom","london-united-kingdom","sheffield-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Tralokinumab + TCS for Atopic Dermatitis","inPlainEnglish":"The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \\[SC\\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life.","whoItsFor":["Ages 6 Months to 11 Years","Age 6 months to \\<12 years at screening","Body weight ≥9 kg at screening","Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD","History of AD for: ≥12 months for subjects aged ≥6 years at screening and ≥3 months for subjects aged 6 months to \\<6 years at screening","Documented inadequate response to mid-strength TCS within 6 months before the screening visit","AD involvement of ≥10% body surface area at screening and baseline according to component A of SCORAD","An EASI score of ≥16 at screening and baseline"],"whoShouldSkip":["Treatment with the topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), topical phosphodiesterase-4 inhibitors (PDE-4), and topical Janus kinase inhibitors (JAK) within 1 week prior to baseline","Treatment with bleach baths within 1 week prior to baseline","Use of tanning beds or phototherapy within 4 weeks prior to baseline","Treatment with a live (attenuated) or non-live vaccine within 30 days prior to the baseline visit","Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment such as seborrheic dermatitis, active skin infection, scabies, cutaneous T cell lymphoma, or psoriasis","Clinically significant active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antifungals or antiprotozoal within 2 weeks before the baseline visit","History of past or current hepatitis B or C including a positive hepatitis B or C test at screening"],"whatHappens":"If you join, the listed intervention(s) are Tralokinumab + TCS, or Placebo + TCS. The registry lists allocation as randomized. The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections \\[SC\\]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 195 people at 61 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.817Z"},{"nctId":"NCT06312137","title":"A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)","officialTitle":"A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).","conditions":["Non Small Cell Lung Cancer"],"keywords":["Carcinoma","Lung cancer","Non-small cell lung cancer"],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Rescue medication"}],"enrollment":780,"startDate":"2024-04-03","completionDate":"2034-02-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The key inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \\[N2\\]) per AJCC eighth edition guidelines\n* Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy\n* Is able to undergo surgery based on opinion of investigator after consultation with surgeon\n* Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy\n* Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.\n* Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period\n* Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention\n\nExclusion Criteria:\n\n* Has one of the following tumor locations/types:\n\n  * NSCLC involving the superior sulcus\n  * Large cell neuro-endocrine cancer (LCNEC)\n  * Sarcomatoid tumor\n  * Diagnosis of SCLC or, for mixed tumors, presence of small cell elements\n* Has Grade ≥2 peripheral neuropathy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \\>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention\n* Has received prior neoadjuvant therapy for their current NSCLC diagnosis\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication\n* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years\n* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening\n* Has an active infection requiring systemic therapy\n* Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has a history of allogeneic tissue/solid organ transplant\n* Has not adequately recovered from major surgery or have ongoing surgical complications\n* Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy","locations":[{"facility":"UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group-Research Department ( Site 0062)","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beverly Hills Cancer Center ( Site 0070)","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute ( Site 0040)","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian ( Site 0096)","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Francisco Oncology Associates ( Site 0066)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stamford Hospital ( Site 0083)","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida ( Site 0014)","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Cancer Center ( Site 0038)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Florida Hematology and Oncology Center ( Site 0018)","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoebe Putney Memorial Hospital ( Site 4016)","city":"Albany","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Atlanta Hospital ( Site 4000)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University School of Medicine-Phase I ( Site 0056)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northside Hospital ( Site 0055)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research Columbus Cancer Center ( Site 0005)","city":"Columbus","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Southeastern Regional Medical Center ( Site 0065)","city":"Newnan","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lewis Cancer and Research Pavilion ( Site 0063)","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Archbold Cancer Center ( Site 0071)","city":"Thomasville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)","city":"Elmhurst","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"North Shore University Health System ( Site 4014)","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare of Duly ( Site 4005)","city":"Lisle","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)","city":"Naperville","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Parkview Research Center at Parkview Regional Medical Center ( Site 0089)","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Arnett Cancer Center ( Site 0076)","city":"Lafayette","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)","city":"Edgewood","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU Health Baton Rouge North Clinic ( Site 4003)","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Cancer Specialists ( Site 0095)","city":"Westbrook","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester ( Site 0073)","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy South - David M Sindelar Cancer Center ( Site 0098)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Research - David C. Pratt Cancer Center ( Site 0006)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Health Morristown Medical Center ( Site 0077)","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cayuga Medical Center ( Site 0086)","city":"Ithaca","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital at Stony Brook ( Site 0054)","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"White Plains Hospital ( Site 0091)","city":"White Plains","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hightower Clinical, LLC ( Site 0084)","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University ( Site 0052)","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)","city":"Lancaster","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Joseph's Candler Health System ( Site 4010)","city":"Bluffton","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina-Hollings Cancer Center ( Site 0045)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Cancer Center ( Site 0053)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute- Research ( Site 0090)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Medical Center Knoxville ( Site 0082)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Millennium Research & Clinical Development ( Site 0039)","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute ( Site 0042)","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Británico de Buenos Aires-Oncology ( Site 0207)","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Británico-Clinical Oncology Department ( Site 0206)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque ( Site 0205)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Aleman-Oncology ( Site 0202)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westmead Hospital ( Site 0701)","city":"Westmead","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Prince Charles Hospital ( Site 0700)","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital-Medical Oncology ( Site 0705)","city":"Murdoch","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)","city":"Innsbruck","state":"Tyrol","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)","city":"Linz","state":"Upper Austria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401)","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antwerp University Hospital-Thoracic Oncology ( Site 1503)","city":"Edegem","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)","city":"Yvoir","state":"Namur","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"VITAZ ( Site 1500)","city":"Sint-Niklaas","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Câncer ( Site 0301)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nossa Senhora da Conceição ( Site 0302)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia Saint Gallen ( Site 0319)","city":"Santa Cruz do Sul","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0305)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)","city":"Greenfield Park","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 0104)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Marys Hospital Center ( Site 0107)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre ( Site 0105)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"FALP-UIDO ( Site 0401)","city":"Providencia","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica RedSalud Vitacura ( Site 0412)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill-Clinical Area ( Site 0400)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"ONCOCENTRO APYS-ACEREY ( Site 0410)","city":"Viña del Mar","state":"Valparaiso","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)","city":"Beijing","state":"Beijing 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The registry lists allocation as randomized. The study will assess the how well it works and safety of 2 dose regimens of pegozafermin compared to dummy treatment (placebo) for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,350 people at 306 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.155Z"},{"nctId":"NCT06318442","title":"The GAPSID Study - How GLP-1 Analogues Prevent Steroid-Induced Diabetes","officialTitle":"How GLP-1 Analogues Prevent Steroid-Induced Diabetes","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Imperial College London","sponsorClass":"OTHER","summary":"TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study)\n\nDESIGN: A double-blind study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. This is a mechanistic experimental medicine study.\n\nAIMS: To evaluate the mechanisms by which GLP-1 analogues reduce steroid-induced hyperglycaemia compared to metformin.\n\nOUTCOME MEASURES:\n\n* Primary: Glucose tolerance in response to standardised mixed meal test (MMT) lasting for 240 minutes, measured in all participants at baseline and on day 7 DEX.\n* Secondary: Indices of insulin resistance (M-value), beta-cell function (acute insulin response to glucose) and disposition, as measured by a combined IV glucose tolerance test and hyperinsulinaemic-euglycaemic clamp, performed at baseline and on day 7 DEX.\n* Exploratory: Tissue specific changes in adipose AMPK determined from adipose and muscle biopsies, taken from a subset of approximately 8 individuals in each group.\n\nELIGIBILITY: People living with pre-diabetes or lifestyle controlled diabetes\n\nSTUDY DURATION: This study will take place over 3 weeks for each partcipant. Study procedures include 10 days of baseline continuous glucose monitoring (CGM) followed by 7 days of dexamethasone with GLP-1, metformin or placebo. Participants will attend a follow-up visit 3-5 days after completing the 7-day course of study drug. The study will run over a period of 3 years.\n\nANTICIPATED IMPACT: Mechanistic evidence for the use of GLP-1 analogues, compared with metformin, in the treatment of steroid-induced diabetes.","conditions":["Steroid-Induced Diabetes","Steroid Induced Hyperglycemia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide Oral Product"},{"type":"DRUG","name":"Metformin Oral Tablet"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2024-05-15","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥ 18 years;\n* Male or female;\n* Pre-diabetes (HbA1c ≥42 and \\<47 mmol/mol, or lifestyle-controlled diabetes (HbA1c ≥48 and ≤52 mmol/mol); measurements within range on two separate occasions ≥90 days apart)\n* Body mass index ≥22.5 kg/m2\n\nExclusion Criteria:\n\n* Prior treatment with any diabetes medication within 90 days;\n* Current or planned pregnancy, or current breastfeeding;\n* Previous treatment with GC (topical, oral, injected) within 30 days or 90 days for extended-release injected GCs (e.g. Depo-Medrone);\n* Continuing requirement for GC treatment (e.g. for steroid replacement, chronic inflammatory or immunological condition);\n* Treatment with medications altering DEX pharmacokinetics (e.g. phenytoin, carbamazepine, ritonavir).\n* History of pancreatitis, renal disease (eGFR \\<30), severe hepatic impairment, gallbladder disorders, or GI disease (e.g. IBD), heart failure, history of medullary thyroid cancer (MTC), or previous skin reactions.\n* History of bleeding disorders of anticoagulant therapies (exclusion from the biopsy substudy only)\n* History of giving blood or having taken part in another non-related study in the last three months\n* History of any other medical, psychological condition, or use of any medications, which, in the opinion of the investigators, would either interfere with the study or compromise the safety of the participant.","locations":[{"facility":"Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Katharine Lazarus, MBChB, BSc","phone":"07555717544","email":"k.lazarus@imperial.ac.uk"}],"primaryOutcomes":["Difference in Glucose tolerance"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["semaglutide"],"locationSlugs":["london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Semaglutide Oral Product for Steroid-Induced Diabetes","inPlainEnglish":"TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study) DESIGN: A neither you nor the study doctors know who gets the real treatment study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily. 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The registry lists allocation as randomized. TITLE: How GLP-1 Analogues prevent steroid-induced diabetes (The GAPSID Study) DESIGN: A neither you nor the study doctors know who gets the real treatment study evaluating how GLP-1 analogues, compared with metformin, prevent hyperglycaemia in response to a 7-day course of dexamethasone (DEX) 6 mg once daily.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at London. 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(DFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","los-alamitos-california","los-angeles-california","orange-california","san-diego-california","sherman-oaks-california","aurora-colorado","lakewood-colorado","san-luis-colorado","tampa-florida","chicago-illinois","jeffersonville-indiana","wichita-kansas","new-orleans-louisiana","hanover-maryland","boston-massachusetts","detroit-michigan","royal-oak-michigan","omaha-nebraska","new-brunswick-new-jersey","new-york-new-york","syracuse-new-york","charlotte-north-carolina","raleigh-north-carolina","bala-cynwyd-pennsylvania","lancaster-pennsylvania","myrtle-beach-south-carolina","germantown-tennessee","knoxville-tennessee","nashville-tennessee","austin-texas","dallas-texas","houston-texas","spokane-washington","buenos-aires-argentina","chabas-argentina","c-rdoba-argentina","mar-del-plata-argentina","rosario-argentina","graz-austria","innsbruck-austria","leopoldsdorf-wien-austria","linz-austria","salzburg-austria","aalst-belgium","brugge-bruges-belgium","edegem-belgium","gent-ghent-belgium","leuven-belgium","sint-niklaas-belgium","yvoir-belgium","barretos-brazil","campinas-brazil","natal-brazil","porto-alegre-brazil","salvador-brazil","santo-andr-brazil","s-o-paulo-brazil","beijing-china","changsha-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","nanjing-china","shanghai-china","tianjin-china","r-mqi-china","wenzhou-china","wuhan-china","xinshi-china","xuzhou-china","hradec-kr-lov-czechia","olomouc-czechia","prague-czechia","aarhus-denmark","copenhagen-denmark","herlev-denmark","odense-denmark","roskilde-denmark","lille-france","limoges-france","lyon-france","marseille-france","paris-france","quint-fonsegrives-france","rennes-france","toulouse-france","villejuif-france","berlin-germany","braunschweig-germany","cologne-germany","dresden-germany","frankfurt-am-main-germany","hamburg-germany","herne-germany","jena-germany","m-nchen-germany","straubing-germany","stuttgart-germany","hong-kong-hong-kong","cork-ireland","dublin-ireland","haifa-israel","ramat-gan-israel","sderot-israel","tel-aviv-israel","yeruham-israel","arezzo-italy","bergamo-italy","brescia-italy","milan-italy","romagnano-italy","rozzano-italy","torino-italy","amagasaki-japan","kawasaki-japan","kobe-japan","kumamoto-japan","osaka-japan","ta-ku-japan","saitama-japan","wakayama-japan","yokohama-japan","yokosuka-japan","bialystok-poland","bydgoszcz-poland","lublin-poland","przemy-l-poland","tarn-w-poland","torun-poland","wiele-poland","wroclaw-poland","chuncheon-south-korea","gyeongin-south-korea","sangam-dong-south-korea","seoul-south-korea","alzira-spain","barcelona-spain","cadiz-spain","castill-n-spain","jerez-de-la-frontera-spain","la-coru-a-a-coru-a-spain","madrid-spain","m-laga-spain","oviedo-spain","sabadell-spain","seville-spain","valencia-spain","zmir-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","bristol-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","sheffield-united-kingdom","southampton-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Gemcitabine for Non-Muscle Invasive Bladder Neoplasms","inPlainEnglish":"The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.","whoItsFor":["Ages 18 Years to any","Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing","Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy","Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the how well it works of the study treatment","Have an Eastern Cooperative Oncology Group performance status of 0 to 2"],"whoShouldSkip":["Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy","Polyuria with recorded 24-hour urine volumes \\> 4000 milliliters (mL)","Current indwelling urinary catheters, however, intermittent catheterization is acceptable","Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)","\\- Previous diagnosis of histologically confirmed urothelial bladder carcinoma at any time prior to current qualifying diagnosis"],"whatHappens":"If you join, the listed intervention(s) are TAR-210, Gemcitabine, or MMC. The registry lists allocation as randomized. The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 641 people at 193 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.318Z"},{"nctId":"NCT06319963","title":"A Study to Evaluate Lenti-HPV-07 Immunotherapy Against HPV+ Cervical or Oropharyngeal Cancer","officialTitle":"An Open-Label Phase 1/2a Clinical Trial to Evaluate the Safety, Immunogenicity, and Preliminary Efficacy of a Lentiviral Vector-Based Therapeutic Vaccine Against Human Papilloma Virus (Lenti-HPV-07) in Participants With HPV-Associated Oropharyngeal Squamous Cell Cancer or Cervical Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Theravectys S.A.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn about the safety and efficacy of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).\n\nThe main questions aim to answer are:\n\n* Is Lenti-HPV-07 safe?\n* Does Lenti-HPV-07 induce an immune response?\n\nParticipants will be assigned to a group based on their cancer type\n\n* either study drug group A: recurrent and/or metastatic cancer\n* or study drug group B: newly diagnosed with locally advanced cancer\n\nAfter they finish the study treatment, they will be followed for up to 1 year. Follow-up visits will occur via clinic visits or phone calls 4 weeks after the last study treatment and then quarterly for up to 1 year.","conditions":["HPV-Related Cervical Carcinoma","HPV Positive Oropharyngeal Squamous Cell Carcinoma"],"keywords":["HPV16","Cervical Cancer","Oropharyngeal cancer","Immuno-oncotherapy","Head and Neck Cancers","T-cell vaccine","Lentiviral Vector","Anti-tumor immunity","Early E- and E7 antigens","HPV18","Human Papillomavirus"],"interventions":[{"type":"DRUG","name":"Two IM injections Lenti-HPV-07"},{"type":"DRUG","name":"One IM injection Lenti-HPV-07"}],"enrollment":72,"startDate":"2024-08-08","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* histologically confirmed invasive HPV-related oropharyngeal or cervical cancer\n* ECOG performance status of 0 or 1\n* adequate hepatic, renal, pulmonary, and bone marrow/hematological function\n\nExclusion Criteria:\n\n\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection","locations":[{"facility":"Florida Cancer Specialists (from Sarah Canon research Institute)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Cancer Specialists and Research Institute, LLC","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anastasia DEMIDOV","phone":"+33","email":"ademidova@theravectys.com"}],"primaryOutcomes":["Safety and Tolerability","OBD"],"hasResults":false,"conditionSlugs":["cervical-cancer","head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["orlando-florida","tampa-florida","tulsa-oklahoma"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Two IM injections Lenti-HPV-07 for HPV-Related Cervical Carcinoma","inPlainEnglish":"The goal of this clinical trial is to learn about the safety and how well it works of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV). The main questions aim to answer are: * Is Lenti-HPV-07 safe?","whoItsFor":["Ages 18 Years to any","histologically confirmed invasive HPV-related oropharyngeal or cervical cancer","how well you can do daily activities (ECOG score) of 0 or 1","adequate hepatic, renal, pulmonary, and bone marrow/hematological function"],"whoShouldSkip":["\\- with seropositivity for HIV, active hepatitis C virus (HCV) infection, or hepatitis B (HBV) infection"],"whatHappens":"If you join, the listed intervention(s) are Two IM injections Lenti-HPV-07, or One IM injection Lenti-HPV-07. The registry lists allocation as randomized. The goal of this clinical trial is to learn about the safety and how well it works of a potential new treatment called Lenti-HPV-07 in patients with a cancer induced by Human Papilloma Virus (HPV).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 72 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.329Z"},{"nctId":"NCT06322667","title":"A Post Marketing Study in Participants With Early Alzheimer's Disease Treated With Lecanemab","officialTitle":"A Multicenter, Postmarketing Observational Study to Evaluate Safety Regarding Amyloid-Related Imaging Abnormalities and Their Management in Patients With Early Alzheimer's Disease and Treated With Lecanemab","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eisai Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.","conditions":["Alzheimer's Disease"],"keywords":["Early Alzheimer's Disease","Lecanemab","ARIA"],"interventions":[{"type":"OTHER","name":"No Intervention"}],"enrollment":5000,"startDate":"2024-02-14","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* All participants who are treated with lecanemab in routine clinical practice\n\nExclusion Criteria:\n\n* None","locations":[{"facility":"Eisai trial site 2","city":"Hiroshima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eisai trial site 3","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eisai trial site 1","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eisai Inquiry Service.","phone":"","email":"eisai-chiken_hotline@hhc.eisai.co.jp"}],"primaryOutcomes":["Number of Participants With Amyloid Related Imaging Abnormality-Oedema/Effusion (ARIA-E) and Amyloid Related Imaging Abnormality-Microhemorrhage and Hemosiderin Deposit, and Cerebellar Microhaemorrhage (ARIA-H)","Number of Participants With Interruption or Discontinuation of Lecanemab After Onset of ARIA"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["hiroshima-japan","kyoto-japan","tokyo-japan"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention for Alzheimer's Disease","inPlainEnglish":"The primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (ARIA) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of ARIA in routine clinical practice in participants treated with lecanemab.","whoItsFor":["Ages 18 Years to any","All participants who are treated with lecanemab in routine clinical practice"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.233Z"},{"nctId":"NCT06323447","title":"Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia","officialTitle":"Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Leuko Labs, Inc.","sponsorClass":"INDUSTRY","summary":"Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.","conditions":["Diffuse Large B Cell Lymphoma","Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"PointCheck"}],"enrollment":210,"startDate":"2025-12-15","completionDate":"2027-06-30","sex":"ALL","minAge":"10 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.\n* Male or Female aged 10 years or above.\n* Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma.\n* Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines.\n* Able (in the investigator's opinion) and willing to comply with all study requirements.\n\nExclusion Criteria:\n\n* Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator.\n* Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.\n* Participants with circulating tumour cells in previous or current lab determinations.\n* Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).\n* Unstable participants or participants with hypotension (systolic blood pressure \\<90 and diastolic blood pressure \\< 60mmHg).\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.","locations":[{"facility":"University of Hawaii Cancer Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Healthcare Cancer Center","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachussetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New 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intermediate/high risk antineoplastic therapy.","whoItsFor":["Ages 10 Years to any","Male or Female aged 10 years or above","Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma","Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines"],"whoShouldSkip":["Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator","Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold","Participants with circulating tumour cells in previous or current lab determinations","Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor)","Unstable participants or participants with hypotension (systolic blood pressure \\<90 and diastolic blood pressure \\< 60mmHg)","Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study","Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 210 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.517Z"},{"nctId":"NCT06324357","title":"Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread","officialTitle":"Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) Alone or in Combination With Other Agents for the Treatment of Patients With Advanced HER2+ Metastatic Breast Cancer (mBC), Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (mGEAC), or Metastatic Colorectal Cancer (mCRC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a suitable dose of zongertinib that people with different types of HER2+ cancer that has spread can tolerate best when taken alone or together with trastuzumab deruxtecan (T-DXd), with trastuzumab emtansine (T-DM1), with trastuzumab with or without capecitabine, with zanidatamab with or without docetaxel, or with mFOLFOX6 (with or without trastuzumab). Another purpose is to check whether zongertinib alone and in combination with other treatments can make tumours shrink. Zongertinib inhibits HER2. HER2 causes cancer cells to grow.\n\nIn this study, participants receive treatment in cycles. Study participants are treated with zongertinib alone or in combination with other treatments. This study has 2 parts. In Part 1, participants in different groups receive increasing doses of zongertinib. In Part 2, participants are put into different groups by chance. Each group receives a different dose of zongertinib. Every participant has an equal chance of being in each group.\n\nDuring the study, the participants visit the study site regularly. In this study, researchers want to find the highest dose of zongertinib that participants can tolerate when taken alone or together with other treatments. To find this out, researchers look at certain severe health problems that a number of participants have. The doctors regularly check the size of the tumour with imaging methods (CT/MRI) during the study. The doctors also regularly check participants' health and take note of any unwanted effects.","conditions":["Metastatic Breast Cancer","Metastatic Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma","Esophageal Adenocarcinoma","Colorectal Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Zongertinib"},{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Trastuzumab emtansine"},{"type":"DRUG","name":"Trastuzumab"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"mFOLFOX6"},{"type":"DRUG","name":"zanidatamab"},{"type":"DRUG","name":"Docetaxel"}],"enrollment":910,"startDate":"2024-06-28","completionDate":"2029-01-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n* Cohorts A to K and Cohort O and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC).\n* Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification\n* For (Phase II): Patient must provide tumor tissue\n* History of prior treatment lines in palliative setting: For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K, O and P documented investigator assessed progression\n* Presence of at least one measurable lesion according to RECIST 1.1\n* Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n* Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n* Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec.\n* Any factors that increase the risk of QT interval corrected for heart rate (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, personal or family history of long QT syndrome or unexplained sudden death under 40 years-of-age.\n* Ejection fraction \\<50% or the lower limit of normal of the institutional standard within 28 days prior to randomization\n* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Further exclusion criteria apply.","locations":[{"facility":"The Oncology Institute of Hope and Innovation","city":"Cerritos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ellison Medical Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sharp Memorial Hospital","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helios CR Inc","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. 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People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful.","whoItsFor":["Ages 18 Years to any","Cohorts A to K and Cohort O and P: Documented Human epidermal growth factor receptor 2 overexpressing and/or amplified (HER2+), metastatic breast cancer (mBC) or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma (mGEAC)","Cohorts L (L-ext), M, and N (metastatic colorectal cancer (mCRC)): Documented Human epidermal growth factor receptor 2 (HER2) overexpression/amplification","For (Phase II): Patient must provide tumor tissue","History of prior treatment lines in palliative setting: For cohorts A, B, C, D, E, F, G, H, I, I-ext, J, J-ext, K, O and P documented investigator assessed progression","Presence of at least one measurable lesion according to RECIST 1.1","Eastern Cooperative Oncology Group (ECOG) score of 0 or 1","Adequate organ function based on laboratory values Further who can join apply"],"whoShouldSkip":["Mean resting corrected QT interval (QT interval corrected for heart rate by Fridericia´s formula (QTcF)) \\>470 msec","Ejection fraction \\<50% or the lower limit of normal of the institutional standard within 28 days prior to randomization","History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening Further"],"whatHappens":"If you join, the listed intervention(s) are Zongertinib, Trastuzumab deruxtecan, or Trastuzumab emtansine. The registry lists allocation as randomized. This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 910 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.977Z"},{"nctId":"NCT06330064","title":"A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)","officialTitle":"A Phase 1B/2 Pan-Tumor, Open-Label Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).","conditions":["Recurrent or Metastatic Solid Tumors"],"keywords":["Recurrent or metastatic solid tumors","Endometrial cancer","Head and neck squamous cell carcinoma","Colorectal cancer","Hepatocellular carcinoma","Adenocarcinoma of esophagus, gastroesophageal junction, and stomach","Urothelial carcinoma","Ovarian cancer","Cervical cancer","Biliary tract cancer","Human epidermal growth factor 2 (HER2)-low breast cancer","HER2 immunohistochemistry 0 breast cancer","Cutaneous melanoma","Pancreatic ductal adenocarcinoma","Ifinatamab deruxtecan (I-DXD)","DS7300a","Neuroendocrine Carcinoma (NEC)"],"interventions":[{"type":"DRUG","name":"Ifinatamab deruxtecan"}],"enrollment":680,"startDate":"2024-04-10","completionDate":"2028-07-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Participants must meet all of the following criteria to be included in the study:\n\nCommon Inclusion Criteria for All Participants\n\n1. Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated. Fresh biopsies are strongly preferred, however, if a fresh pretreatment biopsy is not feasible or the procedure is unsuccessful, an appropriate archival sample must be provided. The most recent archival sample obtained up to 5 years prior to consent is acceptable.\n2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years).\n3. At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator.\n4. Documentation of radiological disease progression on or after the previous standard-of-care regimen. For NEC participants for which the standard therapy does not exist OR for which the standard therapy is not appropriate by the investigator: presence of advanced/metastatic disease without previous regimen is acceptable.\n5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nAdditional Inclusion Criteria for EC Participants\n\n1. Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.\n2. Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Participants with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant/adjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.\n\nAdditional Inclusion Criteria for HNSCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.\n2. Has disease progression after platinum-based and ICI treatment, whether administered in combination or separately. Participants with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 2 prior therapy lines for unresectable or metastatic HNSCC.\n3. Participants without radiographic evidence of major blood vessel invasion/infiltration or tumor demonstrating a greater than (\\>)90-degree abutment or encasement of a major blood vessel.\n4. Participants with no prior history of Grade greater than or equal to (≥)3 bleeding as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 within 28 days prior to the start of study drug related to the current head and neck cancer may be included in the study.\n5. Documented p16 status for oropharyngeal cancer (historical results are acceptable if available).\n\nAdditional Inclusion Criterion for PDAC Participants\n\n1\\. Pathologically or cytologically documented unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the locally advanced/metastatic setting or after 2 lines of therapy if the participant has actionable target tumor mutation and has been previously treated with targeted therapy.\n\na. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for CRC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic CRC with microsatellite stable status (MSS).\n2. Relapse or progression after 1 prior line of systemic therapy including a fluoropyrimidine plus oxaliplatin with or without anti-vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) or anti-epidermal growth factor receptor mAb therapy, as clinically indicated, or relapse or progression after 2 lines of therapy if the subject has received targeted therapy.\n\n   Note: Prior adjuvant/neoadjuvant systemic cytotoxic chemotherapy will count as 1 line of prior systemic therapy if there is documented disease progression during therapy or within 6 months of chemotherapy completion.\n3. No prior treatment with topoisomerase I inhibitors, such as irinotecan or topotecan.\n\nAdditional Inclusion Criteria for HCC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) or noninvasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria in participants with a confirmed diagnosis of cirrhosis.\n2. Relapse or progression after 1 prior line of an ICI-containing regimen (combination or monotherapy) in the locally advanced/metastatic setting, or relapse or progression after 2 lines of therapy if the participant has an actionable target tumor mutation and has been treated with targeted therapy.\n3. Barcelona Clinic Liver Cancer (BCLC) Stage B or C.\n4. Liver function status should be Child-Pugh (CP) Class A.\n5. Albumin-Bilirubin (ALBI) Grade 1 within 7 days prior to the first dose of study drug.\n6. Participants with large esophageal varices at risk of bleeding must be treated with conventional medical intervention: beta blockers or endoscopic treatment.\n\nAdditional Inclusion Criteria for Ad-eso/GEJ/Gastric Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic Ad-eso/GEJ/Gastric that has relapsed or progressed after 1 prior line of systemic therapy in the locally advanced/metastatic setting.\n\n   a. Participants with PD-(L)1+ or MSI-H/dMMR should receive ICI treatment if ICIs are standard of care in the country, unless the participant is ineligible for ICI treatment.\n2. If the participant has known history of HER2 positivity (defined by IHC 3+ or IHC 2+ and in situ hybridization \\[ISH\\] positive, as classified by American Society of Clinical Oncology - College of American Pathologists \\[ASCO CAP\\]) or actionable target, the participant must have been previously treated with a targeted therapy.\n\nAdditional Inclusion Criteria for UC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology.\n2. Relapse or progression after at least 1 prior line of ICI-containing systemic therapy, and 1 prior line of systemic chemotherapy, given in combination with other anticancer therapy or separately, with a maximum of 3 prior therapy lines.\n\n   1. At least 1 line of therapy should include enfortumab vedotin in countries where enfortumab vedotin is approved and available.\n   2. Perioperative systemic therapies will be counted as 1 line of therapy.\n   3. To meet inclusion criteria requirement of prior ICI-containing therapy, use in the perioperative or metastatic setting will suffice.\n   4. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.\n   5. The same regimen administered twice in different disease settings will be counted as 1 line of prior therapy.\n\nAdditional Inclusion Criteria for CC Participants\n\n1. Histologically confirmed unresectable or metastatic CC that was previously treated with ≥1 prior line of systemic therapy in the locally advanced or metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.\n2. Participants should receive prior anti-programmed death 1 (PD-1)//programmed death-ligand 1 (PD-L1) treatment and/or tisotumab vedotin if those are standard of care in the country, unless the participant is ineligible for these treatments.\n\nAdditional Inclusion Criteria for OVC Participants\n\n1. Histologically confirmed high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer that was previously treated with at least 1 line of platinum-based therapy and bevacizumab unless the participant is ineligible for treatment with bevacizumab.\n2. Participant is no longer considered eligible for platinum-based therapy per the investigator's opinion or has progressed less than 180 days after the last dose of platinum therapy.\n3. Participant is not considered primary platinum refractory and has not progressed during platinum treatment or within 4 weeks after the completion of platinum treatment.\n4. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for BTC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BTC (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma).\n2. Relapse or progression after at least 1 prior line of systemic therapy, or 2 prior lines of systemic therapy if the participant has an actionable target and has received targeted therapy.\n3. Histological subtypes other than ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine tumors, mixed tumor histology, and/or mucinous cystic neoplasms (Please note that the histological subtypes listed here are not allowed.)\n\nAdditional Inclusion Criteria for HER2-Low BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Low HER2 expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested), according to ASCO-CAP 2018 HER2 testing guidelines, based on most recent testing, regardless of hormonal status.\n3. Progression on or after treatment with trastuzumab deruxtecan (T-DXd).\n4. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic hormone receptor (HR)+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for HER2 IHC 0 BC Participants\n\n1. Pathologically or cytologically documented unresectable or metastatic BC.\n2. Negative for HER2 expression, defined as IHC 0 (ISH- or untested) according to ASCO-CAP 2018 HER2 testing guidelines, based on the most recent testing, regardless of hormonal status.\n3. Relapse or progression after at least 2 and a maximum of 3 prior lines of systemic therapy. Participants with metastatic HR+ BC who have received endocrine-based therapy and have received at least 2 and a maximum of 3 prior lines of additional systemic therapy in the metastatic setting. Participants with actionable target tumor mutation should have been previously treated with targeted therapy.\n\nAdditional Inclusion Criteria for Cutaneous (Acral and Non-acral) Melanoma Participants\n\n1. Histologically or cytologically confirmed cutaneous (acral and non-acral) melanoma.\n2. Disease progression while on or after having received treatment with ≥1 prior line of ICI based therapy. Prior anti-PD-(L)1 therapy in the adjuvant setting may be counted as 1 line if there is recurrence within 12 weeks of the last dose. If the subject had BRAF mutated melanoma or other actionable target tumor mutation, they must have had disease progression on targeted therapy as well.\n\nAdditional Inclusion Criteria for NEC Participants\n\n1. Histologically or cytologically confirmed NEC types other than neuroendocrine prostate cancer (NEPC), small cell lung cancer (SCLC), and Merkel Cell Carcinoma, as defined by WHO 2022. Participants must meet at least 1 of the following criteria:\n\n   1. Disease that is relapsed/refractory to standard systemic therapy OR\n   2. Disease for which standard therapy does not exist OR\n   3. Disease for which standard therapy is not considered appropriate by the investigator.\n2. Participants with mixed histology of large-cell neuroendocrine carcinoma (LCNEC) and SCLC are eligible if the neuroendocrine component predominates and represents at least 50% of the overall tumor tissue.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.\n2. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.\n3. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.\n4. Inadequate treatment washout period before enrollment as specified in the protocol.\n5. Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.","locations":[{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Cancer Network","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pih Health Hematology Medical Oncology","city":"Whittier","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orchard Healthcare Research Inc","city":"Skokie","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M Health Fairview University of Minnesota Medical Center","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine At Mount Sinai Prime","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Alliance, Inc","city":"Westbury","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"White Plains Hospital","city":"White Plains","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erlanger Health, Inc","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The West Clinic","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - 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1 / Phase 2: testing Ifinatamab deruxtecan for Recurrent or Metastatic Solid Tumors","inPlainEnglish":"This study is designed to assess the how well it works and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).","whoItsFor":["Ages 18 Years to any","Participants must meet all of the following criteria to be included in the study:","Common for All Participants","Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for 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The registry lists allocation as randomized. This study is designed to assess the how well it works and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; cutaneous melanoma; and neuroendocrine carcinoma (NEC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 680 people at 120 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.635Z"},{"nctId":"NCT06332209","title":"Randomized Trial of Tele Vs. Clinic TF-CBT in Puerto Rico","officialTitle":"Addressing Barriers to Care Among Underserved Youth: Telehealth Delivery of Trauma-Focused Cognitive Behavioral Therapy - A Randomized Effectiveness-Implementation Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Medical University of South Carolina","sponsorClass":"OTHER","summary":"The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomized controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes. Goals are also to support the feasibility, acceptability, and engagement outcomes of Tele-health delivery.","conditions":["Post-Traumatic Stress Disorder"],"keywords":["trauma focused cognitive behavioral therapy","telehealth","community implementation"],"interventions":[{"type":"BEHAVIORAL","name":"Trauma Focused Cognitive Behavioral Therapy"}],"enrollment":80,"startDate":"2025-04-01","completionDate":"2028-09-30","sex":"ALL","minAge":"7 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 7-18 years old\n* experienced at least one traumatic event\n* present with clinically significant levels of post-traumatic stress symptoms\n\nExclusion Criteria:\n\n* significant suicidal ideation\n* substance use disorder\n* active psychotic symptoms\n* pervasive developmental delays,\n* currently living with or in close contact with the perpetrator of their abuse","locations":[{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Regan Stewart, PhD","phone":"843-792-4195","email":"stewartr@musc.edu"}],"primaryOutcomes":["Traumatic Stress Symptoms","Traumatic Stress Symptoms"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["charleston-south-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Trauma Focused Cognitive Behavioral Therapy for Post-Traumatic Stress Disorder","inPlainEnglish":"The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomly assigned controlled trial. Goals of the current study are to examine the effectiveness of Tele-TF-CBT delivered by community providers in Puerto Rico in improving youth trauma outcomes.","whoItsFor":["Ages 7 Years to 18 Years","experienced at least one traumatic event","present with clinically significant levels of post-traumatic stress symptoms"],"whoShouldSkip":["significant suicidal ideation","substance use disorder","active psychotic symptoms","pervasive developmental delays,","currently living with or in close contact with the perpetrator of their abuse"],"whatHappens":"If you join, the listed intervention(s) are Trauma Focused Cognitive Behavioral Therapy. The registry lists allocation as randomized. The current study will evaluate TF-CBT delivered via tele-health for youth presenting with trauma symptoms via a randomly assigned controlled trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Charleston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.412Z"},{"nctId":"NCT06336382","title":"Tau Biomarkers in Late-onset Psychosis (LOP)","officialTitle":"Tau Biomarkers in Late-onset Psychosis (LOP)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Jeremy Koppel","sponsorClass":"OTHER","summary":"Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.","conditions":["Late Onset Schizophrenia","Delusional Disorder (Late Onset)"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Tau PET imaging scan"}],"enrollment":16,"startDate":"2024-02-16","completionDate":"2026-12-31","sex":"ALL","minAge":"65 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female, aged 65-85 years.\n2. Diagnosis of late-onset non-affective primary psychotic disorder consistent with either very late-onset schizophrenia-like psychosis (VLOSP, International Late-Onset Schizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)\n3. Caregiver available to provide collateral history and participation in informant-based ratings (NPI,CDR)\n4. Clinical Dementia Rating (CDR) score of 0 or 0.5.\n5. Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit.\n6. Normal memory function (to rule-out mild cognitive impairment, MCI) documented by scoring within 1.5 SD range in education adjusted norms of the Logical Memory II subscale\n7. Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted).\n\nExclusion Criteria:\n\n1. Participants with affective and psychotic disorders including bipolar disorder, schizoaffective disorder, active major depression; insulin dependent type 2 diabetes; a history of CVD; a history of epilepsy; a history of TBI with greater than 15 minutes of loss of consciousness; a movement disorder including Parkinson's disease; stroke; autoimmune disease affecting the CNS; substance abuse disorder; or active delirium/encephalopathy.\n2. Evidence of a clinically relevant neurological disorder\n3. Modified Hachinski ischemia score of more than 4.\n4. History of alcoholism or drug dependency/abuse within the last 5 years before screening.\n5. Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel.\n6. Inability to lie flat for 1 hour approximately.\n7. Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation. Subjects with hearing aids will be allowed to participate if they meet minimum hearing requirements.","locations":[{"facility":"The Feinstein Institutes for Medical Research","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nichole Hoehn, MS","phone":"516-562-3492","email":"nhoehn@northwell.edu"},{"name":"Erica Christen, MS","phone":"516-562-3492","email":"EChriste@northwell.edu"}],"primaryOutcomes":["Quantification of neurofibrillary tangle pathology in subjects via PET [18F]PI-2620 radiotracer uptake."],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["manhasset-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Tau PET imaging scan for Late Onset Schizophrenia","inPlainEnglish":"Hallucinations or delusions that occur for the first time in older people with no acute medical problems or mood symptoms may be related to impending dementia. This study aims to confirm this hypothesis using novel blood biomarkers and Positron Emission Tomography (PET) imaging tracers, as well as non-invasive testing.","whoItsFor":["Ages 65 Years to 85 Years","Male or female, aged 65-85 years","Diagnosis of late-onset non-affective primary psychotic disorder consistent with either very late-onset schizophrenia-like psychosis (VLOSP, International Late-Onset Schizophrenia Group consensus criteria, Howard et al., 2000) or delusional disorder (DSM-5 criteria)","Clinical Dementia Rating (CDR) score of 0 or 0.5","Mini-Mental State Examination (MMSE) score ≥ 24 and at the screening visit","Normal memory function (to rule-out mild cognitive impairment, MCI) documented by scoring within 1.5 SD range in education adjusted norms of the Logical Memory II subscale","Ability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation (hearing aids permitted)"],"whoShouldSkip":["Evidence of a clinically relevant neurological disorder","Modified Hachinski ischemia score of more than 4","History of alcoholism or drug dependency/abuse within the last 5 years before screening","Presence of metal implants such as pacemakers, ear implants, internal bullet fragments or shrapnel","Inability to lie flat for 1 hour approximately","Hearing impairment as evidenced by the inability to hear 500, 1000 and 1500 Hz bilaterally on a hearing evaluation. Subjects with hearing aids will be allowed to participate if they meet minimum hearing requirements"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 16 people at Manhasset. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.039Z"},{"nctId":"NCT06337032","title":"A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments","officialTitle":"An Open-label, Single-arm Study to Provide Continued Access to Study Drug to Participants Who Have Completed Pediatric Clinical Studies Involving Gilead HIV Treatments","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for adverse events.\n\nThe primary objectives of this study are as follows:\n\n* To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.\n* To evaluate the safety of the study drug(s) in participants with HIV-1.","conditions":["HIV-1-infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"F/TAF (High Dose Tablet)"},{"type":"DRUG","name":"F/TAF (Low Dose Tablet)"},{"type":"DRUG","name":"F/TAF (Lowest Dose Tablet)"},{"type":"DRUG","name":"F/TAF (High Dose TOS)"},{"type":"DRUG","name":"F/TAF (Low Dose TOS)"},{"type":"DRUG","name":"F/TAF (Lowest Dose TOS)"},{"type":"DRUG","name":"E/C/F/TAF"},{"type":"DRUG","name":"E/C/F/TAF (Low Dose)"},{"type":"DRUG","name":"Cobicistat (High Dose)"},{"type":"DRUG","name":"Cobicistat (Low Dose)"},{"type":"DRUG","name":"Cobicistat (TOS)"},{"type":"DRUG","name":"B/F/TAF (High Dose)"},{"type":"DRUG","name":"B/F/TAF (Low Dose)"},{"type":"DRUG","name":"B/F/TAF (High Dose TOS)"},{"type":"DRUG","name":"B/F/TAF (Low Dose TOS)"},{"type":"DRUG","name":"B/F/TAF (Lowest Dose TOS)"},{"type":"DRUG","name":"3rd ARV Agent"},{"type":"DRUG","name":"Nucleos(t)ide reverse transcriptase inhibitors (NRTI)"},{"type":"DRUG","name":"ATV"},{"type":"DRUG","name":"DRV"},{"type":"DRUG","name":"Lopinavir Boosted with ritonavir (LPV/r)"}],"enrollment":350,"startDate":"2024-08-27","completionDate":"2027-06","sex":"ALL","minAge":"1 Month","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation.\n\nKey Exclusion Criteria:\n\n* Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit.\n\n  * Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).\n* Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch.\n* For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance.\n* For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients.\n* Ongoing treatment with or prior use of any prohibited medications.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Helios Salud","city":"Buenos Aires","state":"","country":"Argentina","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital del Niño","city":"Panama City","state":"","country":"Panama","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Stellenbosch","city":"Cape Town","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Enhancing Care Foundation","city":"Durban","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"WITS RHI Research Centre","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rahima Moosa Mother and Child Hospital","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Part Yoluntu Centre","city":"Paarl","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Aurun Institute","city":"Pretoria","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perinatal HIV Research Unit","city":"Soweto","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine - Mahidol University","city":"Bangkok Noi","state":"","country":"Thailand","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Khon Kaen University","city":"Khon Kaen","state":"","country":"Thailand","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Joint Clinical Research Centre","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"MU-JHU Research Collaboration/MU-JHU Care Ltd","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Strengthening Institutional Capacity for Research Administration (SICRA)","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Africa Medical and Behavioral Sciences Organisation","city":"Masaka","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Zimbabwe Clinical Research Centre","city":"Harare","state":"","country":"Zimbabwe","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Number of Eligible Participants Who Have Received Access to the Study Drug(s) in the Study"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["buenos-aires-argentina","panama-city-panama","cape-town-south-africa","durban-south-africa","johannesburg-south-africa","paarl-south-africa","pretoria-south-africa","soweto-south-africa","bangkok-noi-thailand","khon-kaen-thailand","kampala-uganda","masaka-uganda","harare-zimbabwe"],"enrichment":{"headline":"Phase 4: testing F/TAF (High Dose Tablet) for HIV-1-infection","inPlainEnglish":"The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for side effects. The primary objectives of this study are as follows: * To provide continued access to the study drug received in the parent protocol or switch to bictegravir/emtricitabine/tenofovir (B/F/TAF) for participants who completed a Gilead parent study evaluating drugs for HIV treatment.","whoItsFor":["Ages 1 Month to any","Completed an applicable parent study: GS-US-292-0106, GS-US-380-1474, GS-US-311-1269, or GS-US-216-0128, and gave consent to study participation"],"whoShouldSkip":["Individuals planning to switch to B/F/TAF on Day 1 with plasma HIV RNA ≥ 50 copies/mL during the last parent study visit prior to screening/Day 1 visit","Note: individuals planning to switch after Day 1 must not have plasma HIV RNA ≥ 50 copies/mL (or detectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)","Individuals planning to switch to B/F/TAF with any ongoing Grade 3 or 4 drug-related AE or clinically relevant Grade 3 or 4 drug-related laboratory abnormality (confirmed on repeat) related to any component of B/F/TAF prior to treatment switch","For those on B/F/TAF or planning to switch to B/F/TAF: previous treatment discontinuation of any component of B/F/TAF due to toxicity or intolerance","For those planning to switch to B/F/TAF: known hypersensitivity to any component of the study drug, its metabolites, or formulation excipients","Ongoing treatment with or prior use of any prohibited medications","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are F/TAF (High Dose Tablet), F/TAF (Low Dose Tablet), or F/TAF (Lowest Dose Tablet). The registry lists allocation as randomized. The goal of this clinical study is to provide continued access to the study drug(s) to children and adolescents with human immunodeficiency virus type 1 (HIV-1) who completed their participation in an applicable parent study and to monitor for side effects.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 350 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.531Z"},{"nctId":"NCT06337318","title":"Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma","officialTitle":"Randomized Phase III Study of Mosunetuzumab vs. Rituximab for Low Tumor Burden Follicular Lymphoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. It is not yet known if giving rituximab or mosunetuzumab works better in treating patients with follicular lymphoma with a low tumor burden.","conditions":["Classic Follicular Lymphoma","Follicular Lymphoma With Unusual Cytological Features"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"BIOLOGICAL","name":"Mosunetuzumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"BIOLOGICAL","name":"Rituximab and Hyaluronidase Human"}],"enrollment":600,"startDate":"2024-10-23","completionDate":"2032-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory.\n\n  * NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required.\n* Participants must not have follicular lymphoma with \"blastoid\" or \"large centrocyte\" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)\n* Participants must have low-tumor burden follicular lymphoma defined as:\n\n  * Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter\n  * Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm.\n  * Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight)\n  * No symptomatic splenomegaly\n  * No compression syndrome (ureteral, orbital, gastrointestinal)\n  * No pleural or peritoneal serous effusion related to follicular lymphoma Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to undergo radiation or are not candidates for radiation\n* Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach\n* Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and pelvis, along with a bone marrow biopsy, are acceptable. If CT scans are used for staging at baseline, a CT scan of the neck is recommended. All measurable dominant lesions must be assessed within 49 days prior to registration. Tests to assess non-measurable disease must be performed within 49 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.\n\n  * NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast\n* Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter \\> 1.5 cm)\n* Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed\n* Participant must be ≥ 18 years of age at the time of registration\n* Participant must have Zubrod performance status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 3 x 10\\^3/uL (within 28 days prior to registration)\n* Hemoglobin \\> 9.0 g/dL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3/uL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3/uL (within 28 days prior to registration)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to registration)\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)\n* Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been collected and processed within 28 days prior to registration\n* Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators\n* Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators\n* Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated. Participants with a positive total hepatitis (Hep) B core antibody and negative hepatitis B virus surface antigen (HBsAg) at screening are at high risk for reactivation and should receive prophylactic antivirals (e.g., entecavir) before and throughout the treatment\n* Participants must not have autoimmune disease requiring systemic immunosuppressive therapy\n* Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required\n* Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML)\n* Participants must not have received allogeneic stem cell transplantation\n* Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. Participant must not have significant cardiovascular disease such as class III or IV cardiac disease, myocardial infarction within 6 months prior to registration. Participants with unstable arrhythmias, or unstable angina, should be excluded\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants registered by participating United States (U.S.) sites must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Rogers","city":"Rogers","state":"Arkansas","country":"United 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ine":"Phase 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It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells.","whoItsFor":["Ages 18 Years to any","Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic follicular lymphoma (FL) is no longer mandatory","NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization (FISH) is not required. Molecular testing is not required","Participants must not have follicular lymphoma with \"blastoid\" or \"large centrocyte\" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)","Participants must have low-tumor burden follicular lymphoma defined as:","Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter","Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm","Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Mosunetuzumab. The registry lists allocation as randomized. This phase III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 288 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.158Z"},{"nctId":"NCT06340568","title":"A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer","officialTitle":"A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BioNTech SE","sponsorClass":"INDUSTRY","summary":"The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.\n\nIn Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \\[or docetaxel, if participants cannot take paclitaxel\\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).\n\nIn Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment.\n\nThe safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.","conditions":["Endometrial Cancer"],"keywords":["Human epidermal growth factor receptor 2 (HER2)","HER2-expressing tumors","Recurrent endometrial cancer","IHC scores 1+, 2+, and 3+","Immune checkpoint inhibitor","Platinum-based therapy","HER2 protein expression","HER2-expressing endometrial cancer","ErbB-2 receptor","Antibody drug conjugate (ADC)"],"interventions":[{"type":"DRUG","name":"BNT323/DB-1303"},{"type":"DRUG","name":"Doxorubicin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Docetaxel"}],"enrollment":480,"startDate":"2025-06-10","completionDate":"2028-03","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).\n* Have histologically confirmed endometrial cancer that:\n\n  * Is recurrent,\n  * Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and\n  * Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.\n* Have measurable disease defined by RECIST v1.1.\n* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.\n* Have recurrent endometrial cancer and meet any of the following:\n\n  * developed recurrence \\<12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or\n  * developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting.\n* Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)\n* Have a life expectancy of ≥12 weeks at screening.\n\nKey Exclusion Criteria:\n\n* Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).\n* Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n* Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.\n* Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).\n* Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.\n* Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.\n* Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.\n* Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.\n* Had prior treatment with topoisomerase I inhibitors, including ADCs.\n* Have left ventricular ejection fraction \\<55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio \\>15.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"USC/Norris Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broward Health Medical Center","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Francis Medical 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3: testing BNT323/DB-1303 for Endometrial Cancer","inPlainEnglish":"The study is divided into two cohorts (Cohort 1 and Cohort 2), to which you would be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \\[or docetaxel, if participants cannot take paclitaxel\\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs).","whoItsFor":["Ages 18 Years to any","Women only","Have histologically confirmed endometrial cancer that:","Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and","Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed","Have measurable disease defined by RECIST v1.1","Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2","Have recurrent endometrial cancer and meet any of the following:","developed recurrence \\<12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or"],"whoShouldSkip":["Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only)","Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment","Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring side effects","Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment","Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening","Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment","Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline"],"whatHappens":"If you join, the listed intervention(s) are BNT323/DB-1303, Doxorubicin, or Paclitaxel. The registry lists allocation as randomized. The study is divided into two cohorts (Cohort 1 and Cohort 2), to which you would be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 480 people at 214 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.685Z"},{"nctId":"NCT06345729","title":"A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)","officialTitle":"A Phase 3, Randomized, Double-blind, Multicenter Study of MK-1084 in Combination With Pembrolizumab Compared With Pembrolizumab Plus Placebo as Firstline Treatment of Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic NSCLC With PD-L1 TPS ≥50% (KANDLELIT-004)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This is a study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis:\n\nCombination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).","conditions":["Non-small Cell Lung Cancer"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C)"],"interventions":[{"type":"DRUG","name":"Calderasib"},{"type":"OTHER","name":"Placebo"},{"type":"BIOLOGICAL","name":"Pembrolizumab"}],"enrollment":348,"startDate":"2024-05-24","completionDate":"2028-01-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)\n* Has newly diagnosed Stage IIIB/IIIC NSCLC, not eligible for curative resection or curative chemotherapy/radiation as determined by a multidisciplinary tumor board and/or by radiation oncologist, surgeon, and medical oncologist or Stage IV (M1a, M1b, or M1c) by American Joint Committee on Cancer (AJCC) Staging Manual, Version 8\n* Provides an archival tumor sample (≤5 years) or newly obtained core, incisional, or excisional biopsy or fine needle aspirate (FNA) of a tumor lesion, not previously irradiated to enable central laboratory testing of kirsten rat sarcoma (KRAS) G12C mutation status, programmed cell death ligand 1 (PD-L1) status, and biomarker research\n* If have had adverse events (AEs) due to previous anticancer therapies, must have recovered to \\< Grade 1 or baseline\n* If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)\n* If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has diagnosis of small cell lung cancer. For mixed tumors, if small cell elements are present, the participant is ineligible\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n* Has known history of, or active, neurologic paraneoplastic syndrome\n* Has an active infection requiring systemic therapy, with exceptions\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has received prior systemic anticancer therapy for their locally advanced or metastatic NSCLC\n* Has received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Has received radiotherapy to non-central nervous system (CNS) disease within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not required corticosteroids, and not have had radiation pneumonitis\n* Has known active CNS metastases and/or carcinomatous meningitis\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Is HIV-infected and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has history of allogenic tissue/solid organ transplant\n* Has not fully recovered from any effects of major surgical procedure","locations":[{"facility":"CBCC Global Research, Inc. ( Site 0123)","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beverly Hills Cancer Center ( Site 0116)","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stamford Hospital ( Site 0136)","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Cancer Center ( Site 0137)","city":"Miami Beach","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Orchard Healthcare Research Inc. 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3: testing Calderasib for Non-small Cell Lung Cancer","inPlainEnglish":"This is a study evaluating the how well it works and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to dummy treatment (placebo) plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).","whoItsFor":["Ages 18 Years to any","The main inclusion and"],"whoShouldSkip":["include but are not limited to the following:","who can join:","Has histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)","If have had side effects (AEs) due to previous anticancer therapies, must have recovered to \\< Grade 1 or baseline","If human immunodeficiency virus (HIV)-infected, must have well controlled HIV on antiretroviral therapy (ART)","If Hepatitis B surface antigen (HBsAg) positive, have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load","If a participant has a history of Hepatitis C virus (HCV) infection, HCV viral load is undetectable"],"whatHappens":"If you join, the listed intervention(s) are Calderasib, Placebo, or Pembrolizumab. The registry lists allocation as randomized. This is a study evaluating the how well it works and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 348 people at 247 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.732Z"},{"nctId":"NCT06347094","title":"Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols","officialTitle":"Precision Nutrition to Improve Cardiometabolic Health With Dietary (Poly)Phenols (PRE-CARE-DIET)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"SINGLE","sponsor":"University of Parma","sponsorClass":"OTHER","summary":"This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an observational part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping.","conditions":["Individual Variability in (Poly)Phenol Metabolism","Cardiometabolic Health","Personalized Dietary Intervention","Obesity"],"keywords":["nutritional intervention study","personalized nutrition","cardiometabolic risk","obesity","(poly)phenols","metabotypes","inter-individual variability","food-gut-host interactions","predictive models"],"interventions":[{"type":"OTHER","name":"Personalized Dietary Plan"},{"type":"DIETARY_SUPPLEMENT","name":"Oral (Poly)phenol Challenge Test (OPCT)"},{"type":"OTHER","name":"General Dietary Advice"}],"enrollment":330,"startDate":"2024-04-22","completionDate":"2027-02-28","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (40-80 y.o.)\n* Non-clinically diagnosed for cardiometabolic diseases at baseline examination\n* At least one of the following risk factors: overweight or obese, central obesity (waist:hip ratio \\> 0.90 in males and \\> 0.85 in females or waist circumference ≥ 94 cm in males and ≥ 80 cm in females), hypertension (systolic BP \\> 130 or diastolic BP \\> 85 mm Hg), low high-density lipoprotein cholesterol levels (\\< 40 mg/dL (1.03 mmol/L) in males, \\< 50 mg/dL (1.29 mmol/L) in females), or elevated total cholesterol (≥ 200 mg/dL), low-density lipoprotein cholesterol (≥ 130 mg/dL (4.1 mmol/L)), triglyceride (\\> 150 mg/dL (1.7 mmol/L)), fasting glucose (\\> 100 mg/dL (5.6 mmol/L)) levels, or microalbuminuria (urinary albumin excretion ratio ≥ 20 μg/min or albumin:creatinine ratio ≥ 30 mg/g). In addition, it is necessary that the weight has been stable for at least 3 months. Similarly, concerning an ongoing therapy with medication or supplements, these must have been in use for at least 3 months.\n\nExclusion Criteria:\n\n* BMI \\< 18.5 or \\> 40.0 kg/m²\n* Past cardiovascular events and metabolic diseases including diabetes\n* Inflammatory bowel diseases or gastro-intestinal surgery (other than appendectomy)\n* Cholecystectomy within the past 5 years\n* Renal or hepatic diseases\n* Levels of estimated Glomerular Filtration (eGFR) \\< 60 mL/min/1.73 m²\n* Aspartate transaminase (AST)/alanine aminotransferase (ALT) 2.5 times the upper limits of normal\n* Immunodeficiency or autoimmune diseases (other than well-compensated hypothyroidism)\n* Mental disorders\n* Hormone therapy (other than that used for hypothyroidism, birth-control or menopause symptoms)\n* Antibiotic therapy within the last month before the study\n* Food allergies associated with the consumption of plant foods or foods that will be provided in the study\n* Difficulties or major inconveniences in changing dietary habits or adhering to a plant-based Mediterranean-type diet\n* Presence of chewing or swallowing disorders\n* Pregnancy or lactation","locations":[{"facility":"University of Parma - Plesso Biotecnologico Integrato","city":"Parma","state":"PR","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria di Parma","city":"Parma","state":"PR","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pedro M Mena Parreño, PhD","phone":"+39 0521 903970","email":"pedromiguel.menaparreno@unipr.it"},{"name":"Maria Sole Morandini, MSc","phone":"+39 0521902043","email":"mariasole.morandini@unipr.it"}],"primaryOutcomes":["Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation","Assessing the effect of a (poly)phenol-rich diet on 10-year cardiovascular risk: Systematic Coronary Risk Estimation-Older Persons"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["parma-italy"],"enrichment":{"headline":"Not a traditional drug phase: Personalized Dietary Plan for Individual Variability in (Poly)Phenol Metabolism","inPlainEnglish":"This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response. This study presents an watch-and-measure (no experimental treatment required) part, for targeted recruitment and volunteers characterization, and an experimental part for the dietary and deep phenotyping.","whoItsFor":["Ages 40 Years to 80 Years","Adults (40-80 y.o.)","Non-clinically diagnosed for cardiometabolic diseases at baseline examination"],"whoShouldSkip":["body-mass index (BMI) \\< 18.5 or \\> 40.0 kg/m²","Past cardiovascular events and metabolic diseases including diabetes","Inflammatory bowel diseases or gastro-intestinal surgery (other than appendectomy)","Cholecystectomy within the past 5 years","Renal or hepatic diseases","Levels of estimated Glomerular Filtration (eGFR) \\< 60 mL/min/1.73 m²","Aspartate transaminase (AST)/alanine aminotransferase (ALT) 2.5 times the upper limits of normal"],"whatHappens":"If you join, the listed intervention(s) are Personalized Dietary Plan, Oral (Poly)phenol Challenge Test (OPCT), or General Dietary Advice. The registry lists allocation as randomized. This chronic study aims at assessing whether the effects of a personalized, plant-based diet rich in (poly)phenols on cardiometabolic health depend on the capability to metabolize dietary (poly)phenols, creating predictive models able to explain, at individual level, the cardiometabolic response.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 330 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.833Z"},{"nctId":"NCT06350929","title":"Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients","officialTitle":"Evaluation of Norepinephrine in the Management of General Anesthesia-Induced Arterial Hypotension in Chronic Heart Failure Patients in the Operating Room.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Toulouse","sponsorClass":"OTHER","summary":"Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction. Chronic heart failure (CHF) patients are increasingly encountered in the operating room, and their perioperative morbidity and mortality are substantial, with specific management lacking precise recommendations.\n\nThe main objective is to assess the impact of a diluted norepinephrine bolus on cardiac output in chronic heart failure patients experiencing arterial hypotension after anesthesia induction.","conditions":["Hypotension"],"keywords":["Chronic heart failure","Norepinephrine","General anaesthesia"],"interventions":[{"type":"OTHER","name":"Cardiac output monitoring by the Starling™ SV Sebac®"}],"enrollment":50,"startDate":"2024-10-17","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients\n* Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable.\n* Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations.\n* Scheduled surgery under general anesthesia.\n* Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure).\n* Postoperative monitoring planned in intensive care or intensive care\n* Presence of controlled mechanical ventilation with tidal volumes between 8 and 10 ml/kg of ideal weight.\n* Presence of arterial hypotension after induction of general anesthesia, and before surgical stimulation.\n* Patient affiliated to a social security scheme or equivalent\n* No opposition from the patient.\n\nExclusion Criteria:\n\n* Chronic heart failure patients with right ventricular failure.\n* Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt.\n* Patients operated on under general anesthesia but maintaining spontaneous ventilation.\n* Patients with respiratory compliance disorders with compliances greater than 30 cm of water.\n* Patients with intra-abdominal hypertension.\n* Patients with supraventricular or ventricular arrhythmia.\n* Patients treated with catecholamines prior to the procedure.\n* Patients operated on for urgent surgeries\n* Patient under guardianship, curatorship or safeguard of justice\n* Pregnant or breastfeeding women.","locations":[{"facility":"CHU Toulouse Rangueil","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"François LABASTE, Dr","phone":"0561322822","email":"labaste.f@chu-toulouse.fr"}],"primaryOutcomes":["Evaluation of the impact of a bolus of diluted norepinephrine on cardiac output in chronic heart failure patients presenting with arterial hypotension after anesthetic induction."],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["toulouse-france"],"enrichment":{"headline":"Not a traditional drug phase: Cardiac output monitoring by the Starling™ SV Sebac® for Hypotension","inPlainEnglish":"Arterial hypotension is a frequent complication of general anesthesia and a significant contributor to postoperative complications. It is a critical marker for the development of acute renal failure and postoperative myocardial infarction.","whoItsFor":["Ages 18 Years to any","Heart failure patients with left ventricular failure with a ventricular ejection fraction less than or equal to 40% evaluated by trans-thoracic echocardiography less than a year ago and specifying in particular the patient's filling pressures at the state stable","Patients under treatment adapted to the level of heart failure according to the 2021 European Society of Cardiology recommendations","Scheduled surgery under general anesthesia","Invasive hemodynamic monitoring planned by the anesthetist-resuscitator (irrespective of potential inclusion in the protocol): arterial catheter and central venous line for measurement of CVP (central venous pressure)","Postoperative monitoring planned in intensive care or intensive care","Presence of controlled mechanical ventilation with tidal volumes between 8 and 10 ml/kg of ideal weight","Presence of arterial hypotension after induction of general anesthesia, and before surgical stimulation"],"whoShouldSkip":["Chronic heart failure patients with right ventricular failure","Patients presenting signs of acute pulmonary edema, Pulmonary arterial hypertension (PAH), severe valvular disease, intracardiac shunt","Patients operated on under general anesthesia but maintaining spontaneous ventilation","Patients with respiratory compliance disorders with compliances greater than 30 cm of water","Patients with intra-abdominal hypertension","Patients with supraventricular or ventricular arrhythmia","Patients treated with catecholamines prior to the procedure"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at Toulouse. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.435Z"},{"nctId":"NCT06351631","title":"A Study to Evaluate Safety and Efficacy of Bomedemstat (MK-3543-017)","officialTitle":"A Multicenter, Open-Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Participants Enrolled in a Prior Bomedemstat Clinical Study","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The primary purpose of the study is to transition participants into an extension study to collect long-term safety and efficacy data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria:\n\n* Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat;\n* Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic response.\n\nNo hypothesis testing will be conducted in this study.","conditions":["Thrombocythemia, Essential","Primary Myelofibrosis","Myelofibrosis","Post-polycythemia Vera Myelofibrosis","Post-essential Thrombocythemia Myelofibrosis","Polycythemia Vera"],"keywords":[],"interventions":[{"type":"DRUG","name":"Bomedemstat"}],"enrollment":400,"startDate":"2024-05-23","completionDate":"2034-12-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \\& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready\n* Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator\n* ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic response, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator\n* Is not currently on a dose hold\n* Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat\n\nExclusion Criteria:\n\n* Has received prohibited concomitant medications\n* Ongoing or planned participation in another investigational study\n* Has noncompliance in prior bomedemstat study receiving \\<90% of assigned doses excluding suspensions or holds as assigned by the investigator","locations":[{"facility":"University of Michigan ( Site 6000)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DUHS Duke Blood Cancer Center ( Site 6005)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center ( Site 6004)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Prince Alfred Hospital ( Site 1003)","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal North Shore Hospital ( Site 1001)","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunshine Coast Hematology and Oncology Clinic ( Site 1006)","city":"Buderim","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gold Coast University Hospital-Cancer and Blood Disorders Clinical Trial Team ( Site 1002)","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital-Haematology Clinical Trials Unit ( Site 1000)","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Health ( Site 1004)","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Mary Hospital ( Site 1601)","city":"Hksar","state":"","country":"Hong Kong","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Careggi ( Site 2700)","city":"Florence","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria SS. Antonio e Biagio e Cesare Arrigo ( Site 2703)","city":"Alessandria","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 2702)","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale di Circolo e Fondazione Macchi Varese ( Site 2701)","city":"Varese","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Shore Hospital-Department of Haematology ( Site 1401)","city":"Auckland","state":"","country":"New Zealand","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Aotearoa Clinical Trials ( Site 1400)","city":"Auckland","state":"","country":"New Zealand","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Imperial College Healthcare NHS Trust - Hammersmith Hospital ( Site 3402)","city":"London","state":"Hammersmith and Fulham","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Pilgrim Hospital ( Site 3403)","city":"Boston","state":"Lincolnshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospital ( Site 3400)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's & St Thomas' NHS Foundation Trust ( Site 3401)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Percentage of participants with one or more adverse events (AEs)","Percentage of participants who discontinued study treatment due to an AE"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan","durham-north-carolina","columbus-ohio","pittsburgh-pennsylvania","camperdown-australia","st-leonards-australia","buderim-australia","southport-australia","adelaide-australia","clayton-australia","hksar-hong-kong","florence-italy","alessandria-italy","bologna-italy","varese-italy","auckland-new-zealand","london-united-kingdom","boston-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Bomedemstat for Thrombocythemia, Essential","inPlainEnglish":"The primary purpose of the study is to transition participants into an extension study to collect long-term safety and how well it works data. The study will include participants who are safely tolerating bomedemstat, receiving clinical benefit from its use in estimation of the investigator, and have shown the following criteria: * Participants from the IMG-7289-202/MK-3543-005 (NCT05223920) study must have received at least 6 months of treatment with bomedemstat; * Essential thrombocythemia (ET) and polycythemia vera (PV) participants from studies other than IMG-7289-202/MK-3543-005 must have achieved confirmed hematologic response.","whoItsFor":["Ages 18 Years to any","Is from a bomedemstat study sponsored by Imago BioSciences, Inc. (a subsidiary of Merck \\& Co., Inc.) or MSD, and established by the Sponsor as MK-3543-017 ready","Has received at least 6 months of treatment with bomedemstat in the IMG-7289-202/MK-3543-005 study, while safely tolerating bomedemstat, and receiving clinical benefit from its use in the estimation of the investigator","ET and PV participants from established feeder studies other than IMG-7289- 202/MK-3543-005 must have achieved confirmed hematologic response, must be safely tolerating bomedemstat, and must be receiving clinical benefit from its use in the estimation of the investigator","Is not currently on a dose hold","Participant must be able to swallow oral medication and follow instructions for at-home dosing of bomedemstat"],"whoShouldSkip":["Has received prohibited concomitant medications","Ongoing or planned participation in another investigational study","Has noncompliance in prior bomedemstat study receiving \\<90% of assigned doses excluding suspensions or holds as assigned by the investigator"],"whatHappens":"If you join, the listed intervention(s) are Bomedemstat. The registry lists allocation as na. The primary purpose of the study is to transition participants into an extension study to collect long-term safety and how well it works data.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.622Z"},{"nctId":"NCT06352632","title":"ACT-GLOBAL Adaptive Platform Trial for Stroke","officialTitle":"A Multi-faCtorial, mulTi-arm, Multi-staGe, Randomised, gLOBal Adaptive pLatform Trial for Stroke (ACT-GLOBAL)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"SINGLE","sponsor":"The George Institute","sponsorClass":"OTHER","summary":"Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke. ACT-GLOBAL is a multi-factorial, multi-arm, multi-stage, randomised, global adaptive platform trial for stroke, aiming to identify the treatment/s associated with the highest chance of improving outcome in stroke patients. In ACT-GLOBAL multiple questions will be evaluated simultaneously and sequentially as data accrues and can evaluate interactions between different treatment options.","conditions":["Stroke"],"keywords":["Adaptive Platform Trial","Blood Pressure","Tenecteplase","Ischaemic stroke","Intracerebral Haemorrhage"],"interventions":[{"type":"DRUG","name":"Standard-dose intravenous tenecteplase"},{"type":"DRUG","name":"Low-dose intravenous tenecteplase"},{"type":"OTHER","name":"No intravenous tenecteplase"},{"type":"OTHER","name":"Conservative Blood Pressure Control"},{"type":"OTHER","name":"Moderate Blood Pressure Control"},{"type":"OTHER","name":"Intensive Blood Pressure Control"},{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"NoNO-42"},{"type":"OTHER","name":"No deferoxamine mesylate and no colchicine"},{"type":"DRUG","name":"Deferoxamine mesylate only"},{"type":"DRUG","name":"Colchicine only"},{"type":"DRUG","name":"Both deferoxamine mesylate and colchicine"},{"type":"DRUG","name":"IA thrombolysis"},{"type":"OTHER","name":"no IA thrombolysis"},{"type":"OTHER","name":"IMP-ACT usual care"},{"type":"PROCEDURE","name":"IMP-ACT mechanical endovascular thrombectomy"},{"type":"DRUG","name":"Intra-arterial tenecteplase or alteplase in IMP-ACT"},{"type":"DRUG","name":"CoPRIME aspirin alone"},{"type":"DRUG","name":"CoPRIME aspirin plus clopidogrel"},{"type":"DRUG","name":"CoPRIME aspirin plus ticagrelor"}],"enrollment":20000,"startDate":"2024-09-26","completionDate":"2034-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Platform Inclusion Criteria:\n\n1. Age ≥18 years\n2. Clinical diagnosis of stroke\n\nPlatform Exclusion Criteria:\n\nThere are no platform level exclusion criteria\n\nEach state and domain will specify additional inclusion and exclusion criteria in the respective Domain-Specific Registration. Patients who fulfill the overall platform criteria will be assessed for enrollment into each active domain.","locations":[{"facility":"The George Institute for Global Health","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaoying Chen, PhD","phone":"+61280524549","email":"xchen@georgeinstitute.org.au"},{"name":"Bijoy Menon, MD, PhD","phone":"+14033381198","email":"docbijoymenon@gmail.com"}],"primaryOutcomes":["modified Rankin scale (mRS) scores"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["sydney-australia","calgary-canada"],"enrichment":{"headline":"Phase 3: testing Standard-dose intravenous tenecteplase for Stroke","inPlainEnglish":"Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019. There remains an urgent need for interventions that improve outcomes which can be implemented with wide applicability for stroke.","whoItsFor":["Ages 18 Years to any","Clinical diagnosis of stroke"],"whoShouldSkip":["There are no platform level"],"whatHappens":"If you join, the listed intervention(s) are Standard-dose intravenous tenecteplase, Low-dose intravenous tenecteplase, or No intravenous tenecteplase. The registry lists allocation as randomized. Stroke is causing 6.6 million deaths and is a major cause of disability worldwide in 2019.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 20,000 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.208Z"},{"nctId":"NCT06364410","title":"Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors","officialTitle":"Phase 1 Study of Trastuzumab Deruxtecan (DS-8201a) in Combination With Azenosertib (ZN-c3) in HER2-Expressing/Amplified Gastric/Gastroesophageal Junction Cancer and Other Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.","conditions":["Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage IV Gastric Cancer AJCC v8","Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8","Locally Advanced Gastric Carcinoma","Locally Advanced Gastroesophageal Junction Adenocarcinoma","Locally Advanced Malignant Solid Neoplasm","Metastatic Gastric Carcinoma","Metastatic Gastroesophageal Junction Adenocarcinoma","Metastatic Malignant Solid Neoplasm","Unresectable Gastric Carcinoma","Unresectable Gastroesophageal Junction Adenocarcinoma","Unresectable Malignant Solid Neoplasm"],"keywords":[],"interventions":[{"type":"DRUG","name":"Azenosertib"},{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":48,"startDate":"2025-02-03","completionDate":"2027-07-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* In the dose escalation, patients must have a histologically documented locally advanced, unresectable, or metastatic solid tumor that has progressed following at least one prior line of treatment in the metastatic setting or has no satisfactory alternative treatment option and all of the following:\n\n  * HER2 expression by immunohistochemistry (IHC) (1+, 2+, or 3+) or HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS) (on any Clinical Laboratory Improvements Amendments \\[CLIA\\] platform on tissue), AND\n  * T-DXd (DS-8201a)-naive disease\n* In the dose expansion, patients must have histologically documented locally advanced, unresectable or metastatic gastric or gastroesophageal junction (GEJ) cancer that has progressed following at least one prior line of treatment in the metastatic setting and have all of the following:\n\n  * HER2 expression by IHC (1+, 2+, or 3+) or HER2 amplification by ISH or NGS (on any CLIA platform on tissue), AND\n  * T-DXd (DS-8201a)-naive disease\n  * Received prior trastuzumab-based treatment, if eligible for such treatment\n* For the dose escalation and dose expansion, patients can have evaluable or measurable disease\n* Potential trial participants should have recovered from clinically significant adverse events (AEs) of their most recent therapy/intervention prior to enrollment\n* Age ≥ 18 years. Because no dosing or AE data are currently available on the use of T-DXd (DS-8201a) in combination with azenosertib (ZN-c3) in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 (Karnofsky ≥ 70%). Both T-DXd (DS-8201a) and azenosertib (ZN-c3) have fatigue as an adverse effect. Due to the overlapping adverse effect, the performance status cannot be less restrictive\n* Absolute neutrophil count ≥ 1.5 × 10\\^9/L (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Hemoglobin \\> 9.0 g/dL (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100 × 10\\^9/L (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN). Documented Gilbert syndrome is allowed if total bilirubin is ≤ 3 × institutional ULN (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Aspartate aminotransferase (AST \\[serum glutamic-oxaloacetic transaminase (SGOT)\\])/alanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) ≤ 3 × institutional ULN. In the presence of liver metastases, AST or ALT up to 5 × institutional ULN is permitted (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Measured of calculated creatinine clearance (CrCl) ≥ 60 mL/min (CrCl should be calculated per institutional standard; glomerular filtration rate can also be used in place of CrCl) ≥ 60 mL/min for patients with creatinine levels \\> 1.5 x institutional ULN (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* International normalized ratio/prothrombin time and activated partial thromboplastin time ≤ 1.5 × institutional ULN (within 7 days of study treatment initiation)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n  * No administration of granulocyte colony-stimulating factor is allowed within 1 week prior to screening assessment\n* Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Human immunodeficiency virus-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS-specific treatment is not required and is unlikely to be required during the first cycle of study treatment\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Life expectancy ≥ 3 months\n* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result within 3 days of study treatment initiation\n* Agents composed of HER2 antibody conjugated to a topoisomerase 1 inhibitor and azenosertib (ZN-c3) are known to be teratogenic; thus, WOCBP must agree to use highly effective contraception from time of screening and throughout the study treatment period and for at least 7 months after final study treatment administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period and for at least 7 months after the final study treatment administration\n* Women of non-childbearing potential defined as premenopausal females with documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\> 40 mIU/mL and estradiol \\< 40 pg/mL \\[\\< 147 pmol/L\\] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for WOCBP if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraception method\n* Male patients involved with WOCBP must agree to use a highly effective form of contraception or avoid intercourse from time of screening and throughout the study treatment period and for at least 4 months after the last dose of study treatment. Male patients must not freeze or donate sperm starting at screening and throughout the study period and at least 4 months after the final study treatment administration. Preservation of sperm should be considered prior to enrollment in this study\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Willing to undergo biopsy as required by the study (dose expansion only)\n\n  * Note: Patients in the dose escalation who have insufficient/inadequate archival tissue may have optional pre-treatment biopsy\n* Patients must have adequate washout from prior therapy at the time of study treatment initiation: 4 weeks from major surgery (any surgical incision should be fully healed prior to study drug administration); 4 weeks from antibody-based therapy; 2 weeks or or 5 half-lives (whichever is shorter) from any targeted therapy or small molecule therapy; 3 weeks or 5 half-lives (whichever is shorter) from chemotherapy or 6 weeks in the case of certain therapies (e.g., extensive radiotherapy, mitomycin C, and nitrosoureas); and 4 weeks from radiation therapy. These washout periods are included to ensure patients have maximal bone marrow recovery and as this is a multicenter trial, to ensure uniformity in interpretation of recovery\n\nExclusion Criteria:\n\n* As azenosertib (ZN-c3) is a substrate of CYP3A4, use of prescription or non-prescription drugs known to be moderate or strong inhibitors or inducers of CYP3A4 are prohibited with the exception of moderate or strong inhibitors or inducers of CYP3A4 that are part of the prophylactic antiemetic regimen. Chloroquine/hydroxychloroquine are metabolized by CYP3A4 and therefore, should be prohibited. For patients who have received prior moderate or strong inhibitors or inducers of CYP3A4, the required washout period is approximately 5 half-lives prior to study treatment initiation\n* Patients who are receiving any other investigational agents\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies (mAbs)\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy\n* Patients who require supplemental oxygen for activities of daily living\n* Pregnant women are excluded from this study because T-DXd (DS-8201a) and azenosertib (ZN-c3) have the potential risk for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with T-DXd (DS-8201a) and azenosertib (ZN-c3), breastfeeding should be discontinued if the mother is treated with T-DXd (DS-8201a) or azenosertib (ZN-c3)\n* Patients with history of non-infectious pneumonitis/interstitial lung disease (ILD), current ILD, or where suspected ILD cannot be ruled out by imaging at screening\n* Patients with active infections requiring treatment (antibiotic, antifungal, or antiviral) at the time of study treatment initiation are not eligible. Patients who have completed such treatment and whose infection is controlled/resolved (and afebrile) for at least 7 days before cycle 1 day 1 are eligible\n* Patients with history of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills\n* Patients with current signs or symptoms of bowel obstruction including sub-occlusive disease related to underlying disease\n* Patients with a medical history of myocardial infarction within 6 months before enrollment, symptomatic congestive heart failure (New York Heart Association class IIb to IV), and/or troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to enrollment\n* Patients with clinically significant corneal disease\n* Patients with a pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART). (Drainage and CART are not allowed within 2 weeks prior to screening assessment)\n* Patients with history of Torsades de Pointes unless all risk factors that contributed to Torsades de Pointes have been corrected\n* Based on an average of triplicate 12-lead electrocardiogram (ECG), patients with a mean resting corrected QT (QTc) interval using Fridericia formula of \\> 470 msec for both males and females at screening or a history of congenital long QT syndrome will be excluded\n* Patients with prior treatment with a WEE1 inhibitor (dose escalation and dose expansion)\n* Patients with prior treatment with T-DXd (DS-8201a) or other topoisomerase inhibitors (dose escalation and dose expansion)\n* Patients with uncontrolled intercurrent illness\n* Patients with prior allogeneic organ transplantation including allogeneic stem cell transplantation\n* Patients with clinically significant chronic gastrointestinal disorder with diarrhea as a major symptom; ≥ grade 2 diarrhea at baseline. Please contact the protocol principal investigator (PI) for any patient with more than two episodes of diarrhea per day averaged over at least a 7-day period at time of screening to determine whether the diarrhea would be considered clinically significant\n* Patients with spinal cord compression","locations":[{"facility":"UT MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Maximum tolerated dose","Recommended phase 2 dose","Incidence of dose limiting toxicities (DLTs)","Incidence of adverse events (AEs)"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: testing Azenosertib for Clinical Stage III Gastric Cancer AJCC v8","inPlainEnglish":"This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors.","whoItsFor":["Ages 18 Years to any","HER2 expression by immunohistochemistry (IHC) (1+, 2+, or 3+) or HER2 amplification by in situ hybridization (ISH) or next generation sequencing (NGS) (on any Clinical Laboratory Improvements Amendments \\[CLIA\\] platform on tissue), AND","T-DXd (DS-8201a)-who have not tried this kind of treatment before disease","HER2 expression by IHC (1+, 2+, or 3+) or HER2 amplification by ISH or NGS (on any CLIA platform on tissue), AND","Received prior trastuzumab-based treatment, if eligible for such treatment","For the dose escalation and dose expansion, patients can have evaluable or measurable disease","Potential trial participants should have recovered from clinically significant side effects (AEs) of their most recent therapy/intervention prior to enrollment","Age ≥ 18 years. Because no dosing or AE data are currently available on the use of T-DXd (DS-8201a) in combination with azenosertib (ZN-c3) in patients \\< 18 years of age, children are excluded from this study"],"whoShouldSkip":["Patients who are receiving any other investigational agents","Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs","Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies (mAbs)","Patients who require supplemental oxygen for activities of daily living","Patients with history of non-infectious pneumonitis/interstitial lung disease (ILD), current ILD, or where suspected ILD cannot be ruled out by imaging at screening","Patients with history of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills","Patients with current signs or symptoms of bowel obstruction including sub-occlusive disease related to underlying disease"],"whatHappens":"If you join, the listed intervention(s) are Azenosertib, Biopsy Procedure, or Biospecimen Collection. The registry lists allocation as randomized. This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 48 people at Houston. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.346Z"},{"nctId":"NCT06366113","title":"Time of Exercise Re-training With Chronic Obstructive Pulmonary Disease (COPD)","officialTitle":"Effect of Time of Exercise Re-training on Functional Capacity in Individuals With Chronic Obstructive Pulmonary Disease (COPD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Michaël RACODON","sponsorClass":"OTHER","summary":"Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.\n\nThe program should not be improved by introducing new subjects such as circadian rhythm.","conditions":["Respiratory Diseases"],"keywords":["respiratory diseases","pulmonary rehabilitation","chronic obstructive pulmonary disease","biological clock"],"interventions":[{"type":"OTHER","name":"Pulmonary rehabilitation"}],"enrollment":90,"startDate":"2024-01-02","completionDate":"2024-01-02","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patient with chronic obstructive pulmonary disease (COPD)\n* Registered for respiratory re-education and rehabilitation at the Clinique de la Mitterie\n* Number of rehabilitation sessions at least 18 over 4 weeks\n* Written informed consent signed by the patient\n* Membership of a social security\n\nExclusion Criteria:\n\n* \\- cardiovascular contraindications to exercise\n* unstable respiratory status (uncompensated respiratory acidosis)\n* conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)","locations":[{"facility":"Clinique la Mitterie","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michaël RACODON, PhD","phone":"+33320223457","email":"mracodon@clinique-mitterie.com"}],"primaryOutcomes":["6-minute walk test (6MWT)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["lille-france"],"enrichment":{"headline":"Not a traditional drug phase: Pulmonary rehabilitation for Respiratory Diseases","inPlainEnglish":"Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies. The program should not be improved by introducing new subjects such as circadian rhythm.","whoItsFor":["Ages 18 Years to 85 Years","Patient with chronic obstructive pulmonary disease (COPD)","Registered for respiratory re-education and rehabilitation at the Clinique de la Mitterie","Number of rehabilitation sessions at least 18 over 4 weeks","Membership of a social security"],"whoShouldSkip":["\\- cardiovascular contraindications to exercise","unstable respiratory status (uncompensated respiratory acidosis)","conditions interfering with the pulmonary rehabilitation process (progressive neuromuscular disease, psychiatric illness)"],"whatHappens":"If you join, the listed intervention(s) are Pulmonary rehabilitation. The registry lists allocation as randomized. Pulmonary rehabilitation (PR) is an effective intervention for reducing hospital readmissions, secondary events, and mortality in patients with respiratory pathologies.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Lille. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.654Z"},{"nctId":"NCT06366724","title":"LIFT: Life Improvement Trial","officialTitle":"LIFT: Life Improvement Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"QUADRUPLE","sponsor":"Brigham and Women's Hospital","sponsorClass":"OTHER","summary":"The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI.\n\nThis double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.\n\nThe trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.\n\nThe time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.\n\nThe LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.","conditions":["ME/CFS","Long COVID","PASC"],"keywords":["Chronic fatigue","Mestinon","Low Dose Naltrexone","Orthostatic Intolerance","Post exertional malaise","Cognitive Impairment","Long COVID"],"interventions":[{"type":"DRUG","name":"Pyridostigmine"},{"type":"DRUG","name":"Low-Dose Naltrexone"},{"type":"OTHER","name":"Placebo"}],"enrollment":160,"startDate":"2024-09-10","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS\n2. Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive.\n3. The onset of symptoms prior to December 2023.\n4. Female participant is not pregnant and at least 1 of the following conditions apply:\n\n   1. Not a woman of childbearing potential\n   2. Woman of childbearing potential who agrees to follow the contraceptive guidance. from the time of informed consent.\n5. Participant agrees and can adhere to the study requirements for the length of the study.\n6. Participant has a body mass index (BMI) range of 17 to 40 kg/m2, inclusive.\n7. Participant agrees not to participate in another interventional study while participating in the present study.\n8. Participant has a functioning smart phone to download and run the DANA Brain Vital Mobile Application.\n\nExclusion Criteria:\n\n1. Pregnant, planning to become pregnant, or breastfeeding.\n2. Any use of opioid medications within 30 days of screening.\n3. Positive urine test for opioids\n4. History of alcohol, opioid or other substance misuse\n5. Participation in another interventional clinical trial in the last 30 days or planned during the trial period.\n6. Allergy to medication components\n7. Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation.\n8. Participant has diabetes mellitus (type 1 or 2).\n9. Participant has undergone an inpatient hospitalization within the 30 days prior to the randomization or has a planned hospitalization or a surgical procedure during the study, which may affect the study assessments, in the opinion of the investigator.\n10. Participant has clinically significant respiratory disease (such as chronic obstructive pulmonary disease, cystic fibrosis, severe asthma, lung infections including tuberculosis, sarcoidosis, thoracic endometriosis, pulmonary fibrosis, and lung cancers) and/or cardiac disease (medical history or current clinical findings)\n11. Participant has an active malignancy or any other cancer.\n12. Participant has initiated an exercise regimen within 4 weeks prior to randomization.","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Coordinator","phone":"617-525-6797","email":"jsquires1@bwh.harvard.edu"}],"primaryOutcomes":["Functional Capacity","Physiologic Response - Oxygen Uptake Efficiency Slope (OUES)","Physiologic Response - Oxygen Utilization (VO2)","Physiologic Response - Heart Rate Recovery (HRR)"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: testing Pyridostigmine for ME/CFS","inPlainEnglish":"The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI). Long COVID (LC) subjects will also be included if they meet CCC and have OI.","whoItsFor":["Ages 18 Years to 70 Years","Meet National Academy of Medicine Criteria, Canadian Consensus Criteria (See appendix), and demonstrate orthostatic intolerance for diagnosis of ME/CFS","Participant is ≥ 18 and ≤ 70 years of age at screening, inclusive","The onset of symptoms prior to December 2023","Female participant is not pregnant and at least 1 of the following conditions apply:","Not a woman of childbearing potential","Participant agrees and can adhere to the study requirements for the length of the study","Participant has a body mass index (body-mass index (BMI)) range of 17 to 40 kg/m2, inclusive"],"whoShouldSkip":["Pregnant, planning to become pregnant, or breastfeeding","Any use of opioid medications within 30 days of screening","Positive urine test for opioids","History of alcohol, opioid or other substance misuse","Participation in another treatment clinical trial in the last 30 days or planned during the trial period","Allergy to medication components","Participant has any condition which, in the investigator's opinion, makes the participant unsuitable for study participation"],"whatHappens":"If you join, the listed intervention(s) are Pyridostigmine, Low-Dose Naltrexone, or Placebo. The registry lists allocation as randomized. The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-70 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance (OI).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.234Z"},{"nctId":"NCT06370832","title":"Inspiratory Muscle Training in Lung Transplant Candidates","officialTitle":"Inspiratory Muscle Training in Lung Transplant Candidates and Implications on Early Post-Transplant Outcomes: A Pilot and Feasibility Multicenter Randomized Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Health Network, Toronto","sponsorClass":"OTHER","summary":"Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality. Increasing respiratory muscle strength by inspiratory muscle training (IMT) as part of pre-rehabilitation mitigates respiratory muscle dysfunction peri-operatively and may reduce the risk of post-operative complications. However, IMT is not widely used prior to LTx and the benefits of pre-operative IMT on post-transplant outcomes in LTx candidates have not been studied. Objectives: (1) To evaluate the feasibility of a multicenter randomized clinical trial of IMT in LTx candidates in terms of recruitment rate, retention, program adherence, and outcome ascertainment; (2) To establish the change in pre-transplant dyspnea perception, diaphragm structure and function, health related quality of life (HRQoL) and post-transplant intensive care unit (ICU), hospital and post-transplant 3-month outcomes with IMT relative to usual care group; and (3) To characterize the effect of pre-transplant IMT on peri-transplant diaphragm myofibrillar cross-sectional area (CSA), oxidative capacity, inflammatory markers and post-transplant diaphragm muscle thickness and function (UHN TGH site).","conditions":["Inspiratory Muscle Training"],"keywords":["Lung transplant candidates","Exercise training","Prehabilitation","Chronic Obstructive Pulmonary Disease","Interstitial Lung Disease"],"interventions":[{"type":"OTHER","name":"IMT and exercise training group"}],"enrollment":90,"startDate":"2024-08-06","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult participants (≥ 18 years of age)\n* Lung Transplant Candidates\n* Participating in outpatient pulmonary rehabilitation (standard of care)\n* Diagnosis of Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease\n\nExclusion Criteria:\n\n* Respiratory exacerbation within the last 1 month\n* Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)\n* Insufficient English fluency to provide informed consent or to follow study protocols\n* Any evidence of pneumothorax on recent imaging (\\< 6 months)\n* Present ruptures of eardrums or infections leading to fluid behind ear drum\n* Marked left or right ventricular end-diastolic volume and pressure overload on right heart catheterization or echocardiogram\n* Severe osteoporosis with history of rib fractures\n* Cardiac pacemaker or other electronic or magnetic body implant\n* Individuals listed as rapidly deteriorating or inpatient at the time of eligibility assessment\n* Individuals awaiting a re-transplant\n* Inability of the patient to connect to the internet","locations":[{"facility":"Edmonton Lung Transplant Program","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vancouver General Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dmitry Rozenberg, MD, PhD","phone":"416-340-4800","email":"Dmitry.Rozenberg@uhn.ca"}],"primaryOutcomes":["Study Recruitment According to Research Team Records","Participant Retention in the Study According to Research Team Records","Self-Reported Adherence to Inspiratory Muscle Training According to Participant IMT Diary","Adverse Events and IMT Training Side Effects Reported by Participants","Inspiratory Muscle Training Satisfaction Questionnaire (IMT Group Only)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["edmonton-canada","vancouver-canada","toronto-canada","montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: IMT and exercise training group for Inspiratory Muscle Training","inPlainEnglish":"Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL). In the critical care setting, diaphragm atrophy and weakness have been associated with difficulty weaning from MV, increased risk for readmission to hospital or ICU, and increased mortality.","whoItsFor":["Ages 18 Years to any","Adult participants (≥ 18 years of age)","Lung Transplant Candidates","Participating in outpatient pulmonary rehabilitation (standard of care)","Diagnosis of Interstitial Lung Disease or Chronic Obstructive Pulmonary Disease"],"whoShouldSkip":["Respiratory exacerbation within the last 1 month","Neurologic or musculoskeletal conditions that may interfere with IMT or functional assessments (i.e. history of stroke, severe arthritis of hands)","Any evidence of pneumothorax on recent imaging (\\< 6 months)","Present ruptures of eardrums or infections leading to fluid behind ear drum","Marked left or right ventricular end-diastolic volume and pressure overload on right heart catheterization or echocardiogram","Severe osteoporosis with history of rib fractures","Cardiac pacemaker or other electronic or magnetic body implant"],"whatHappens":"If you join, the listed intervention(s) are IMT and exercise training group. The registry lists allocation as randomized. Recovery after lung transplantation (LTx) may be complicated by prolonged mechanical ventilation (MV) and protracted intensive care unit (ICU) stay leading to immobilization and impaired health-related quality of life (HRQoL).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.652Z"},{"nctId":"NCT06370988","title":"Theta-Burst Stimulation for Bipolar Depression","officialTitle":"Theta-Burst Stimulation for Bipolar Depression","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Centre for Addiction and Mental Health","sponsorClass":"OTHER","summary":"The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation. Participants will come for 30 days of either active iTBS or sham iTBS, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.","conditions":["Bipolar Depression","Bipolar Disorder","Treatment- Resistant Bipolar Disorder","Type 2 Bipolar Disorder"],"keywords":["Transcranial Magnetic Stimulation","Repetitive Transcranial Magnetic Stimulation","rTMS","iTBS"],"interventions":[{"type":"DEVICE","name":"iTBS Stimulation"},{"type":"DEVICE","name":"Sham iTBS Stimulation"}],"enrollment":124,"startDate":"2024-05-15","completionDate":"2029-05","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nThe participant must meet all of the inclusion criteria to eligible for this clinical trial:\n\n1. Must be deemed to have capacity to provide informed consent;\n2. Must be an outpatient\n3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);\n4. Age 18-65;\n5. failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43\n6. moderately severe depression with a score ≥ 15 on the PHQ-9;44\n7. not currently experiencing a mixed or manic episode (YMRS ≤10);\n8. no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \\[3-6mg\\], low-dose benzodiazepines \\[≤2mg lorazepam daily equivalent\\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;\n9. able to adhere to the treatment schedule;\n10. pass the TMS adult safety screening questionnaire.45\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this clinical trial:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);\n4. are pregnant or intend to get pregnant during the study;\n5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;\n6. have psychotic symptoms within the current episode;\n7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;\n8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;\n9. have received any rTMS before due to potential to compromise blinding of treatment allocation;\n10. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);\n11. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n12. are participating in psychotherapy for less than 3 months. Patients will be permitted if they have been in stable treatment for at least 3 months prior to study entry, with no anticipated change in the frequency of therapeutic sessions, or focus of therapeutic sessions over the duration of the study;\n13. are currently taking lorazepam \\>2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;\n14. are currently taking any dose of an anticonvulsant due to the potential to limit rTMS efficacy. If anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;\n15. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).","locations":[{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hannah Taalman","phone":"416-535-8501","email":"Hannah.Taalman@camh.ca"},{"name":"Mawahib Semeralul","phone":"416-535-8501","email":"mawahib.semeralul@camh.ca"}],"primaryOutcomes":["Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: iTBS Stimulation for Bipolar Depression","inPlainEnglish":"The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder. To do this, some of the participants in this study will receive treatment with active iTBS stimulation, while others will receive sham iTBS stimulation.","whoItsFor":["Ages 18 Years to 65 Years","The participant must meet all of the who can join to eligible for this clinical trial:","Must be an outpatient","Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI);","failure to achieve a clinical response to ≥1 adequate treatment trial for bipolar depression based on the Antidepressant Treatment History Form - Short Form (ATHF-SF) OR unable to tolerate at least 2 separate inadequate treatment trials for bipolar depression;43","moderately severe depression with a score ≥ 15 on the PHQ-9;44","not currently experiencing a mixed or manic episode (YMRS ≤10);","able to adhere to the treatment schedule;"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this clinical trial:","have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;","have a concomitant major unstable medical illness;","have active suicidal intent (assessed during HRSD-17 Item 3 and SSRS as imminent intent to act on specific plan, confirmed by psychiatric staff);","are pregnant or intend to get pregnant during the study;","have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;","have psychotic symptoms within the current episode;"],"whatHappens":"If you join, the listed intervention(s) are iTBS Stimulation, or Sham iTBS Stimulation. The registry lists allocation as randomized. The purpose of this trial is to determine if intermittent theta-burst stimulation (iTBS) can reduce the symptoms of depression in treatment-resistant bipolar disorder.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 124 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.747Z"},{"nctId":"NCT06372964","title":"Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).","conditions":["Bipolar Depression"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lumateperone"},{"type":"DRUG","name":"Placebo"}],"enrollment":384,"startDate":"2024-05-14","completionDate":"2031-10-31","sex":"ALL","minAge":"10 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Able to provide consent as follows:\n\n   * The Legally Authorized Representative (LAR) must provide written, informed consent.\n   * The patient must provide written assent;\n2. Male or female patients 10 to 17 years of age, inclusive;\n3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL);\n4. Subject has a lifetime history of at least one manic or hypomanic episode.\n5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;\n6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;\n7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \\[elevated mood\\] score ≤ 2) at Screening and Baseline.\n\nExclusion Criteria:\n\n1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:\n\n   * Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study.\n2. Intellectual disability based on Investigator opinion and DSM-5 criteria\n3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;\n4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;\n5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or\n   3. At Screening or Baseline, scores \\> 3 on Item 13 (suicidal ideation) on the CDRS-R; or\n   4. The patient is considered to be an imminent danger to him/herself or others.","locations":[{"facility":"Harmonex Neuroscience Research","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research, LLC","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center, Inc","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group Inc","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Davis Health System","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego Medical Center","city":"San Diego","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Next Level Clinical Trials, LLC","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCB Clinical Research Centers LLC","city":"Colorado Springs","state":"Colorado","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Royal Palm Clinical Research","city":"Fort Myers","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"United Research Institute","city":"Hialeah","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Advanced Research Institute of Miami","city":"Homestead","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Vital Care Research","city":"Miami","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Columbus Clinical Services LLC","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Care Research Center Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HealthMed Clinical Center Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ocean Blue Medical Research Center Inc.","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"AP Medical Research","city":"Miami","state":"Florida","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Envision Trials LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GTL Medical and Research Group","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Links Clinical Trials","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SouthGen Clinical Research LLC","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"New Med Research Inc","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angel Medical Research Corporation","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riveldi Biomedical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"APG Research LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Synergy Clinical Research","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExeli Research LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Discovery Research","city":"Atlanta","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Salveo Integrative Health Inc","city":"Lawrenceville","state":"Georgia","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"CenExeli Research LLC 1","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revive Research Institute","city":"Elgin","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"MTP Psychiatry LLC","city":"Baltimore","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Neurobehavioral Medicine Group","city":"Bloomfield Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Research Group","city":"Saint Charles","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine Child and Adolescent Psychiatry Clinic","city":"St Louis","state":"Missouri","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Alivation Research LLC","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Child Study Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haidar Almhana Nieding","city":"Avon Lake","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charak Center for Health and Wellness","city":"Garfield Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westlake America Clinic","city":"Westlake","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"SP Research, PLLC (dba Rivus Wellness & Research Institute)","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cutting Edge Research Group","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sooner Clinical Research","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas at Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BioBehavioral Research of Austin PC","city":"Austin","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"REX Clinical Trials LLC","city":"Beaumont","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Pointe Psychiatry","city":"Flower Mound","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Kaleidoscope Clinical Research","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red Oak Psychiatry Associates","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Perceptive Pharma Research","city":"Richmond","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Core Clinical Research","city":"Everett","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones y Proyectos en Neurociencias CIPNA","city":"Barranquilla","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO","city":"Bello","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.","city":"Bogotá","state":"","country":"Colombia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Psynapsis Salud Mental S.A.","city":"Pereira","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ratandeep Surgical Hospital And Endoscopy Clinic","city":"Ahmedabad","state":"","country":"India","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Society for Psychiatric Update and Research Shanti Nursing Home","city":"Chhatrapati Sambhajinagar","state":"","country":"India","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Chopda Medicare & Research Centre","city":"Nashik","state":"","country":"India","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Deva Institute of Healthcare And Research Pvt Ltd","city":"Varanasi","state":"","country":"India","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Clinic of Neurology and Psychiatry for Children and Youth","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mental Health Serbia","city":"Belgrade","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center NIS","city":"Niš","state":"","country":"Serbia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Center of Vojvodina","city":"Novi Sad","state":"","country":"Serbia","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Children's Depression Rating Scale-Revised (CDRS-R)"],"hasResults":false,"conditionSlugs":["depression","schizophrenia"],"drugSlugs":[],"locationSlugs":["dothan-alabama","little-rock-arkansas","anaheim-california","redlands-california","sacramento-california","san-diego-california","west-covina-california","colorado-springs-colorado","fort-myers-florida","hialeah-florida","homestead-florida","miami-florida","miami-gardens-florida","miami-lakes-florida","orlando-florida","west-palm-beach-florida","atlanta-georgia","lawrenceville-georgia","savannah-georgia","chicago-illinois","elgin-illinois","indianapolis-indiana","baltimore-maryland","bloomfield-hills-michigan","saint-charles-missouri","st-louis-missouri","lincoln-nebraska","new-york-new-york","avon-lake-ohio","cincinnati-ohio","garfield-heights-ohio","westlake-ohio","oklahoma-city-oklahoma","austin-texas","beaumont-texas","flower-mound-texas","houston-texas","richmond-texas","richmond-virginia","bellevue-washington","everett-washington","barranquilla-colombia","bello-colombia","bogot-colombia","pereira-colombia","ahmedabad-india","chhatrapati-sambhajinagar-india","nashik-india","varanasi-india","belgrade-serbia","ni-serbia","novi-sad-serbia"],"enrichment":{"headline":"Phase 3: testing Lumateperone for Bipolar Depression","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).","whoItsFor":["Ages 10 Years to 17 Years","The patient must provide written assent;","Male or female patients 10 to 17 years of age, inclusive;","Subject has a lifetime history of at least one manic or hypomanic episode","Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;","CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;","Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \\[elevated mood\\] score ≤ 2) at Screening and Baseline"],"whoShouldSkip":["Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:","Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study","Intellectual disability based on Investigator opinion and DSM-5 criteria","Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;","Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline;","In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or","At Screening, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit;"],"whatHappens":"If you join, the listed intervention(s) are Lumateperone, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 384 people at 68 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.732Z"},{"nctId":"NCT06374238","title":"Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain","officialTitle":"Peer Support for Adolescents and Emerging Adults With Sickle Cell Pain: Promoting Engagement in Cognitive Behavioral Therapy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Pittsburgh","sponsorClass":"OTHER","summary":"The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.\n\nBy leveraging existing infrastructure for delivering virtual peer support interventions, tailored digital CBT programs for individuals with SCD, and partnerships with CBOs, the study aims to provide valuable insights into the feasibility and effectiveness of digital CBT as a pain management strategy for this vulnerable population.","conditions":["Pain","Sickle Cell Disease"],"keywords":["Sickle Cell Disease","Pain management","Cognitive Behavioral Therapy","Wellness"],"interventions":[{"type":"BEHAVIORAL","name":"CBT+ Health coach"},{"type":"BEHAVIORAL","name":"CBT w/o Health Coach ( self-guided)"},{"type":"BEHAVIORAL","name":"Usual Care"}],"enrollment":390,"startDate":"2025-03-10","completionDate":"2028-02","sex":"ALL","minAge":"16 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 16 to 39 years of age at time of enrollment\n2. Sickle Cell Disease diagnosis of any genotype based on referral or documentation\n3. Reports chronic pain (≥4 days/week for past 3 months or more) OR A) Being prescribed pain medication to be taken (≥4 days/week for past 3 months or more) OR B) Taking pain medication (≥4 days/week for past 3 months or more) OR C) Receiving non-pharmaceutical pain treatment (≥4 days/week for past 3 months or more)\n4. Access to an iOS or Android mobile device with internet access\n\nExclusion Criteria:\n\n1. Unable to speak or read English\n2. Prior hematopoietic stem cell transplant for sickle cell disease\n3. Not living in the United States throughout enrollment and duration of the study period","locations":[{"facility":"University of South Alabama Medical Center","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Mattel Children's Hospital Ronald Reagan Hospital","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Connecticut Children's Medical Center","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann and Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Regents of the University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers New Jersey Medical School","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weil Cornell Medical College","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest Baptist Hospital","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University Health Medical Center","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC University of Pittsburgh Classical Hematology Adult Clinic","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Children's Hospital of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Steffi Siebert, MPH","phone":"877-649-0176","email":"presencestudy@pitt.edu"}],"primaryOutcomes":["Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain intensity for AYAs with SCD and chronic pain","Determine the effectiveness of any digital CBT (CBT + peer or self-guided CBT) vs usual care (UC) to improve pain interference for AYAs with SCD and chronic pain"],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["mobile-alabama","los-angeles-california","hartford-connecticut","atlanta-georgia","chicago-illinois","ann-arbor-michigan","newark-new-jersey","new-york-new-york","rochester-new-york","durham-north-carolina","greenville-north-carolina","pittsburgh-pennsylvania","richmond-virginia"],"enrichment":{"headline":"Not a traditional drug phase: CBT+ Health coach for Pain","inPlainEnglish":"The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD. It also seeks to understand the role of personalized peer support in enhancing engagement and outcomes of digital CBT interventions.","whoItsFor":["Ages 16 Years to 39 Years","Aged 16 to 39 years of age at time of enrollment","Sickle Cell Disease diagnosis of any genotype based on referral or documentation","Access to an iOS or Android mobile device with internet access"],"whoShouldSkip":["Unable to speak or read English","Prior hematopoietic stem cell transplant for sickle cell disease","Not living in the United States throughout enrollment and duration of the study period"],"whatHappens":"If you join, the listed intervention(s) are CBT+ Health coach, CBT w/o Health Coach ( self-guided), or Usual Care. The registry lists allocation as randomized. The study, known as the Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE), aims to determine the effectiveness of digital CBT in reducing pain, opioid use, and healthcare utilization among AYAs with SCD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 390 people at 14 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.845Z"},{"nctId":"NCT06375122","title":"Natural History Study of Kaposi Sarcoma","officialTitle":"Natural History Study of Kaposi Sarcoma","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nKaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract. KS is most common in people with compromised immunity, but it also appears in otherwise healthy people. Researchers want to understand more about how KS develops, why it may recur, and how it affects the immune system and organs.\n\nObjective:\n\nTo learn more about the natural history of KS.\n\nEligibility:\n\nPeople aged 18 years and older with KS.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have an imaging scan. They may need a new biopsy: Tissue samples may be cut from their tumor. Their ability to perform normal activities will be assessed.\n\nParticipants will visit the clinic to have their KS evaluated. In addition to the imaging scans and other tests performed during screening, procedures may include:\n\nEye exam.\n\nUltrasound exam of the heart (electrocardiogram).\n\nCollection of saliva and urine samples.\n\nBiopsies of the skin or lymph nodes.\n\nSwabs of the anus and cervix.\n\nPhotographs of skin lesions.\n\nRemoval of fluid samples from the space around the lungs, intestine, or heart.\n\nThe evaluation visit will be repeated 5 more times over 18 months and then yearly for up to 10 years.\n\nParticipants will follow their standard treatment for KS during the study.","conditions":["Kaposi Sarcoma","HIV"],"keywords":["Kaposi Sarcoma","Samples and data collection","Longitudinal clinical evaluations"],"interventions":[],"enrollment":150,"startDate":"2024-05-15","completionDate":"2034-12-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants must have histological KS confirmed by the Laboratory of Pathology (LP), NCI.\n\n* KS as assessed by cutaneous or oral KS lesions or other assessable KS disease.\n* Age \\>=18 years.\n* ECOG performance status \\<=4.\n* Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL).\n* Participants with serious and/or uncontrolled severe intercurrent illness, such as opportunistic infections, that in the judgement of the investigator would preclude participation in the study.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Irene B Ekwede, R.N.","phone":"(240) 760-6126","email":"irene.ekwede@nih.gov"},{"name":"Ramya M Ramaswami, M.D.","phone":"(240) 506-1088","email":"ramya.ramaswami@nih.gov"}],"primaryOutcomes":["To characterize the natural history of Kaposi sarcoma (KS), including presentation, manifestation, and proportion of participants with KS with remission and recurrence by epidemiologic subtype"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History Study of Kaposi Sarcoma","inPlainEnglish":"Background: Kaposi sarcoma (KS) is a type of tumor caused by the Kaposi sarcoma herpesvirus. KS usually affects the skin, but lesions can also appear in the lymph nodes, lungs and digestive tract.","whoItsFor":["Ages 18 Years to 120 Years","Participants must have histological KS confirmed by the Laboratory of Pathology (LP), NCI","KS as assessed by cutaneous or oral KS lesions or other assessable KS disease","how well you can do daily activities (ECOG score) \\<=4"],"whoShouldSkip":["Participants with active KSHV-associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease (MCD), or primary effusion lymphoma (PEL)","Participants with serious and/or uncontrolled severe intercurrent illness, such as opportunistic infections, that in the judgement of the investigator would preclude participation in the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.537Z"},{"nctId":"NCT06377852","title":"The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study","officialTitle":"Comparing Oral Drug Dosing Strategies in Older Patients With Metastatic Breast Cancer to Maximize Tolerance and Reduce Discontinuation: The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"American Society of Clinical Oncology","sponsorClass":"OTHER","summary":"The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.\n\nThe primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 60 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors.\n\nTogether with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing).\n\nNote: Telehealth visits are allowed at any time per institutional guidelines. In addition, the study allows for remote consenting per institutional guidelines.","conditions":["Metastatic Breast Cancer"],"keywords":["MBC"],"interventions":[{"type":"DRUG","name":"Palbociclib 125mg"},{"type":"DRUG","name":"Ribociclib 600mg"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":500,"startDate":"2024-10-29","completionDate":"2028-08-31","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Verification of histology is preferred at the time of recurrence and where not possible or necessary in the judgment of the treating physician, the study will accept histology from the initial diagnosis.\n2. Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient/provider choice.\n3. Aged 60 years or older\n4. Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant by the investigator.\n\n   * Absolute neutrophil count ≥ 1,000/µL\n   * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 5X ULN)\n   * AST (SGOT)/ALT (SGPT) \\<3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver.\n5. Baseline QTc ≤ 480 ms (only for ribociclib patients)\n6. Ability to understand and the willingness to provide informed consent. Note: Remote consent is allowed per institutional guidelines.\n\nExclusion Criteria:\n\n1. Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in the neo/adjuvant breast cancer setting.\n2. Received greater than 60 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the study at the time of randomization.\n3. Known history of intolerance or allergy to the planned agents used in this trial.\n4. Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements.\n5. Concurrent therapy with other investigational agents or anticancer therapy beyond aromatase inhibitors or fulvestrant. Note: radiation is allowed at any time.\n6. Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment.\n7. Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents.\n8. Current use of drugs that have known potential to prolong the QT interval (e.g., antiarrhythmic drugs), for patients on ribociclib. Note: If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated. Refer to crediblemeds.org as a resource.\n9. Prior or concurrent malignancies that are undergoing active treatment.","locations":[{"facility":"Ironwood Cancer & Research Centers","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Goodyear","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Mesa","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Eureka","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Cherry Creek Medical Center","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Highlands Ranch Hospital","city":"Highlands Ranch","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Derby","city":"Derby","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Fairfield","city":"Fairfield","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital at Glastonbury","city":"Glastonbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Greenwich","city":"Greenwich","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Guilford","city":"Guilford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital at Saint Francis","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Yale New Haven Health","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University/Yale Cancer Center/Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - North Haven","city":"North Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Torrington","city":"Torrington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Waterbury","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Waterford","city":"Waterford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liberty County Cancer Care","city":"Hinesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pembroke Medical Oncology & St Joseph's/Candler Oncology Infusion Suite","city":"Pembroke","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lewis Cancer and Research Pavilion","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Candler Medical Oncology Practice and Infusion","city":"Statesboro","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center","city":"Crown Point","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center-Dyer","city":"Dyer","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Mary Medical Center","city":"Hobart","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Powers Health Cancer Research Foundation","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center","city":"Valparaiso","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Jackson Laboratory (JAX) - Harold Alfond Center for Cancer Care","city":"Augusta","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Jackson Laboratory (JAX) - Northern Light Cancer Care","city":"Brewer","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Brigham Cancer Center Foxborough","city":"Foxborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute Merrimack Valley","city":"Methuen","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Brigham Cancer Center at Milford Regional Medical Center","city":"Milford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Brigham Cancer Center at South Shore Health","city":"Weymouth","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber/New Hampshire Oncology-Hematology","city":"Londonderry","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Englewood Hospital","city":"Englewood","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Capital Health Medical Center - Hopewell","city":"Pennington","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine - Princeton Health","city":"Plainsboro","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lovelace Medical Center - Saint Joseph Square","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lovelace Women's Hospital","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Kaseman Hospital","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of New Mexico Comprehensive Cancer Center","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Medical Center","city":"Las Cruces","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Rust Medical Center/Jorgensen Cancer Center","city":"Rio Rancho","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Albemarle","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Concord","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Forest City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Gastonia","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Huntersville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Lincolnton","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Matthews","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Shelby","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center - West Chester Hospital","city":"West Chester","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine - Lancaster General Hospital","city":"Lancaster","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Capital Health Hematology Oncology Specialists","city":"Newton","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine - Perelman Center for Advanced Medicine","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine - Pennsylvania Hospital","city":"Philidelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Medicine - Chester County Hospital","city":"West Chester","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Westerly","city":"Westerly","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph's Candler Bluffton Campus","city":"Bluffton","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SC Cancer Specialists - Hilton Head at St. Joseph's/Candler","city":"Hilton Head Island","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Institute","city":"Rock Hill","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Healthcare","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center at Overlake Cancer Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Bonney Lake","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Federal Way","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Gig Harbor","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center at EvergreenHealth","city":"Kirkland","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Olympia","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Puyallup","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center at University of Washington-Northwest","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jackie Perez, MPH","phone":"571-483-1300","email":"CDKstudy@asco.org"},{"name":"Cindy MacInnis, MBA","phone":"","email":"CDKstudy@asco.org"}],"primaryOutcomes":["Time to Treatment Discontinuation (TTD)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["chandler-arizona","gilbert-arizona","glendale-arizona","goodyear-arizona","mesa-arizona","phoenix-arizona","scottsdale-arizona","eureka-california","santa-rosa-california","aurora-colorado","denver-colorado","highlands-ranch-colorado","derby-connecticut","fairfield-connecticut","glastonbury-connecticut","greenwich-connecticut","guilford-connecticut","hartford-connecticut","new-haven-connecticut","north-haven-connecticut","torrington-connecticut","trumbull-connecticut","waterbury-connecticut","waterford-connecticut","miami-florida","plantation-florida","atlanta-georgia","hinesville-georgia","pembroke-georgia","savannah-georgia","statesboro-georgia","crown-point-indiana","dyer-indiana","hobart-indiana","munster-indiana","valparaiso-indiana","westwood-kansas","augusta-maine","brewer-maine","boston-massachusetts","foxborough-massachusetts","methuen-massachusetts","milford-massachusetts","weymouth-massachusetts","londonderry-new-hampshire","englewood-new-jersey","pennington-new-jersey","plainsboro-new-jersey","albuquerque-new-mexico","las-cruces-new-mexico","rio-rancho-new-mexico","albemarle-north-carolina","charlotte-north-carolina","concord-north-carolina","forest-city-north-carolina","gastonia-north-carolina","huntersville-north-carolina","lincolnton-north-carolina","matthews-north-carolina","monroe-north-carolina","shelby-north-carolina","cincinnati-ohio","west-chester-ohio","lancaster-pennsylvania","newton-pennsylvania","philadelphia-pennsylvania","philidelphia-pennsylvania","west-chester-pennsylvania","westerly-rhode-island","bluffton-south-carolina","hilton-head-island-south-carolina","rock-hill-south-carolina","memphis-tennessee","bellevue-washington","bonney-lake-washington","federal-way-washington","gig-harbor-washington","kirkland-washington","olympia-washington","puyallup-washington","seattle-washington","tacoma-washington"],"enrichment":{"headline":"Phase 3: testing Palbociclib 125mg for Metastatic Breast Cancer","inPlainEnglish":"This study wants to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs.","whoItsFor":["Ages 60 Years to any","Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole, exemestane) or fulvestrant, selected through patient/provider choice","Aged 60 years or older","Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant by the investigator","Absolute neutrophil count ≥ 1,000/µL","Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 5X ULN)","AST (SGOT)/ALT (SGPT) \\<3 x institutional ULN, or ≤ 5 x ULN for subjects with documented metastatic disease to the liver","Baseline QTc ≤ 480 ms (only for ribociclib patients)"],"whoShouldSkip":["Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in the neo/adjuvant breast cancer setting","Received greater than 60 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the study at the time of randomization","Known history of intolerance or allergy to the planned agents used in this trial","Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements","Concurrent therapy with other investigational agents or anticancer therapy beyond aromatase inhibitors or fulvestrant. Note: radiation is allowed at any time","Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment","Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents"],"whatHappens":"If you join, the listed intervention(s) are Palbociclib 125mg, Ribociclib 600mg, or Ribociclib. The registry lists allocation as randomized. This study wants to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 500 people at 87 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.715Z"},{"nctId":"NCT06378736","title":"Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus","officialTitle":"Test of Whether Theta-gamma Coupling Present in Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus Acts as an Objective Marker for Cognitive Dysfunction","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Northwell Health","sponsorClass":"OTHER","summary":"Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life. The goal is to have tools that can be used for diagnosis and for monitoring responses after targeted interventions and therapies. This study will focus on electroencephalographic (EEG) signals, which will be detected noninvasively from scalp placed surface electrodes while the subjects are in a state of wakeful rest. Our hypothesis is that a subset of brain oscillations known as theta and gamma, and their co-modulation or coupling will be disrupted in SLE patients. This research protocol will subject patients with systemic lupus erythematosus (SLE) to scalp electroencephalography (EEG), with the goal of determining whether specific EEG patterns ('theta-gamma coupling') appear abnormal during wakeful-rest periods of 20 minutes. The investigators are interested in using scalp EEG because it is a standard, safe and robust technique for monitoring the electrophysiological activity of neurons in the cerebral cortex.","conditions":["Systemic Lupus Erythematosus"],"keywords":[],"interventions":[{"type":"OTHER","name":"Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest."}],"enrollment":40,"startDate":"2024-04-22","completionDate":"2028-03-23","sex":"FEMALE","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Must be able to understand and provide informed consent.\n2. Must be ≥18 and ≤65years of age.\n3. Must be female.\n4. Must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE or the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) Criteria for SLE.\n5. Must have stable disease activity and medication doses for 4 weeks prior to screening. Stable disease activity is defined as no increase in disease activity requiring an increase or change in medications.\n6. Must be on a corticosteroid dose that is ≤ prednisone 10 mg daily, or equivalent.\n7. Must have demonstrated significantly increased metabolism in the hippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PET imaging.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to give written informed consent or comply with study protocol.\n2. History of neurological diseases including, but not limited to, severe head injury or history of brain surgery, stroke, seizure, toxic exposure, mental retardation, migraine headaches, multiple sclerosis, dementia.\n3. History of documented transient ischemic attacks within 6 months of screening.\n4. History of illicit drug or alcohol dependence/abuse within the past 12 months.\n5. Current use of antipsychotic, anticonvulsant, antidepressant (except for selective serotonin reuptake inhibitors) or anxiolytic medications (short acting anxiolytic medications are allowed if taken as needed with \\> 5 half-lives prior to assessments).\n6. History of chronic pain; current and/or chronic use of narcotic analgesia for \\> 21 days (total) within the last 3 months, or last dose less than 5 days prior to assessment.\n7. Increased disease activity within 4 weeks of screening defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies, which prompts an increase in or new addition of SLE medications.\n8. History of a diagnosis of a primary psychiatric disorder preceding SLE diagnosis.\n9. Current active acute infections requiring antibiotics within 2 weeks of screening and chronic known infections (eg. hepatitis B, C, and/or HIV).\n10. Co-existing other autoimmune disease(s) other than autoimmune thyroid disease and secondary Sjogren's Syndrome.\n11. The presence of uncontrolled, severe hypertension, diabetes or heart disease.\n12. Impaired renal function with an estimated glomerular filtration rate (eGFR)\\< 30.\n13. Presence of any active medical condition that in the opinion of the investigator may contribute to cognitive and/or behavioral disturbances.\n14. Use of investigational drugs within 30 days or 5 half-lives before the study visit, whichever is longer.\n15. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.\n16. Current treatment with cyclophosphamide, addition of belimumab within 4 months, addition of any disease modifying drug or biologic within 3 months of screening, and/or rituxan within 6 months.\n17. Limited fluency with English or Spanish that in the opinion of the investigator would limit the subject's performance on the assessments.\n18. Pregnant and/or lactating women.","locations":[{"facility":"Northwell Health-Feinstein Insitute","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bruce T Volpe, MD","phone":"5165623384","email":"bvolpe1@northwell.edu"}],"primaryOutcomes":["A measure of the amount and relationship of theta and gamma waves in the EEG recording. The ability to perform the block building task and the ability to choose among unfolded three-dimensional objects."],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["manhasset-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Electroencephalography (EEG) signals, which will be detected noninvasively from dry scalp surface electrodes while the subjects are in a state of wakeful rest. for Systemic Lupus Erythematosus","inPlainEnglish":"Patients with systemic lupus erythematosus (SLE) often experience a frustrating decline of their cognitive skills that includes considerable problems in attention, learning, and memory. This lupus-related cognitive dysfunction (termed SLE-CD) is recognized as the most prevalent of the nineteen neuropsychiatric SLE syndromes, as it affects up to 80% of patients and can significantly decrease their quality of life.","whoItsFor":["Ages 18 Years to 65 Years","Women only","Must be ≥18 and ≤65years of age","Must fulfill the 1997 American College of Rheumatology (ACR) revised criteria for the diagnosis of SLE or the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) Criteria for SLE","Must have stable disease activity and medication doses for 4 weeks prior to screening. Stable disease activity is defined as no increase in disease activity requiring an increase or change in medications","Must be on a corticosteroid dose that is ≤ prednisone 10 mg daily, or equivalent","Must have demonstrated significantly increased metabolism in the hippocampus, temporal or parietal lobes on prior fluoro-deoxy glucose (FDG)-PET imaging"],"whoShouldSkip":["History of neurological diseases including, but not limited to, severe head injury or history of brain surgery, stroke, seizure, toxic exposure, mental retardation, migraine headaches, multiple sclerosis, dementia","History of documented transient ischemic attacks within 6 months of screening","History of illicit drug or alcohol dependence/abuse within the past 12 months","Current use of antipsychotic, anticonvulsant, antidepressant (except for selective serotonin reuptake inhibitors) or anxiolytic medications (short acting anxiolytic medications are allowed if taken as needed with \\> 5 half-lives prior to assessments)","History of chronic pain; current and/or chronic use of narcotic analgesia for \\> 21 days (total) within the last 3 months, or last dose less than 5 days prior to assessment","Increased disease activity within 4 weeks of screening defined by an increase in SLEDAI by 3 points or more, exclusive of points from serologies, which prompts an increase in or new addition of SLE medications","History of a diagnosis of a primary psychiatric disorder preceding SLE diagnosis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Manhasset. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.270Z"},{"nctId":"NCT06379646","title":"An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease","officialTitle":"An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"China Immunotech (Beijing) Biotechnology Co., Ltd.","sponsorClass":"INDUSTRY","summary":"An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease","conditions":["Systemic Lupus Erythematosus","Systemic Sclerosis","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome","Sjogren's Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"YTS109"}],"enrollment":6,"startDate":"2024-10-24","completionDate":"2027-04-21","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n3. The functions of important organs meet the following requirements:\n\n   1. Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;\n   2. Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;\n   3. Renal function: creatinine clearance (CrCl) ≥30 ml/minute;\n   4. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;\n   5. Heart function: good hemodynamic stability;\n4. Female subjects with fertility and male subjects whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after the end ofthe study treatment period; Female subjects of childbearing age tested negative for serum HCG within 7 days before enrollment in the study and were not in lactation.\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nSpecific inclusion criteria:\n\nRecurrent refractory systemic lupus erythematosus\n\n1. Complies with the classification standards of the 2019 European Union Against Rheumatology/American Society of Rheumatology (EULAR/ACR) SLE;\n2. Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;\n3. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory sjogren's syndrome\n\n1. Meet the 2002 AECG criteria for primary Sjogren's syndrome or the 2016 ACR/EULAR classification criteria;\n2. Disease activity ESSDAI≥6;\n3. Positive anti-SSA /Ro antibody;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRelapsing refractory/progressive diffuse systemic sclerosis\n\n1. Meet the 2013 ACR classification criteria for systemic sclerosis;\n2. Positive antibodies related to systemic sclerosis;\n3. Diffuse sclerosis of the skin or active interstitial pneumonia (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progression: rapid skin progression (mRSS increase \\>25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).\n6. Note: Articles 4 and 5 satisfy one or the other.\n\nRecurrent refractory/progressive inflammatory myopathy:\n\n1. Meet the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS and NM);\n2. Positive myositis antibody;\n3. Patients with muscle involvement had an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measures (PhGA, PtGA, extra-muscular disease activity score ≥2; HAQ total score ≥0.25; Muscle enzyme levels were 1.5 times the upper limit of the normal range); Or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progressive: myositis aggravation or rapid progression of interstitial pneumonia.\n\nNote: Clauses 4 and 5 satisfy one or the other.\n\nRecurrent/refractory ANCA-associated vasculitis:\n\n1. Meet the 2022ACR/EULAR diagnostic criteria for ANCA vasculitis, including microscopic polyvasculitis, granulomatous polyvasculitis, and eosinophilic granulomatous polyvasculitis.\n2. Anca-associated antibody positive (MPO-ANCA or PR3-ANCA positive);\n3. Birmingham vasculitis activity score (BVAS) ≥15 points (total 63 points), indicating vasculitis disease activity;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory/catastrophic antiphospholipid syndrome:\n\n1. Meet the diagnostic criteria for primary antiphospholipid syndrome as revised in Sydney 2006;\n2. Positive titers of phospholipid antibodies (IgG/IgM of LA, B2GP1 or acL, more than two positive tests within 12 weeks);\n3. Definition of relapse resistance: standard therapy with warfarin anticoagulant or replacement vitamin K antagonists (i.e., maintenance of the INR required for treatment) or with standard therapeutic dose of low molecular weight heparin (LMWH), as well as treatment of recurrent thrombosis with past hormones and cyclophosphamide;\n4. Catastrophic antiphospholipid syndrome needs to meet the following four criteria: (1) involvement of three or more organs, systems and/or tissues; (2) Symptoms appear within 1 week; (3) Histologically confirmed obstruction of small blood vessels in at least one organ or tissue; (4) aPL was positive.\n\nNote: Clauses 3 and 4 satisfy one or the other.\n\nExclusion Criteria:\n\n1. People with severe drug allergy or allergic constitution;\n2. the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;\n3. Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);\n4. Patients with cardiac dysfunction;\n5. Subjects with congenital immunoglobulin deficiency;\n6. History of malignant tumor in recent five years;\n7. Subjects with end-stage renal failure;\n8. Subjects with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive;\n9. Mental illness and severe cognitive impairment;\n10. Participants who had participated in other clinical trials within 3 months before enrollment;\n11. The duration of use of immunosuppressants that have therapeutic effects on the disease before enrollment was within five half-lives or biologics within four weeks;\n12. A woman who is pregnant or planning to become pregnant;\n13. The investigators believe that there are also subjects who could not be included in the study for other reasons.","locations":[{"facility":"Shanghai Changzheng Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Huji Xu","phone":"8602181886999","email":"xuhuji@smmu.edu.cn"}],"primaryOutcomes":["Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Efficacy outcomes for SLE","Efficacy outcomes for Sjogren's Syndrome","Efficacy outcomes for Systemic Sclerosis","Efficacy outcomes for Inflammatory Myopathy","Efficacy outcomes for Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Efficacy outcomes for Antiphospholipid Syndrome"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: YTS109 for Systemic Lupus Erythematosus","inPlainEnglish":"An exploratory clinical study of the safety and how well it works of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease","whoItsFor":["Ages 18 Years to 65 Years","Age ranges from 18 to 65 years old (including threshold), regardless of gender","Positive expression of CD19 on peripheral blood B cells determined by flow cytometry","The functions of important organs meet the following requirements:","Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;","Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;","Renal function: creatinine clearance (CrCl) ≥30 ml/minute;","Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;"],"whoShouldSkip":["People with severe drug allergy or allergic constitution;","the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;","Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);","Patients with cardiac dysfunction;","Subjects with congenital immunoglobulin deficiency;","History of malignant tumor in recent five years;","Subjects with end-stage renal failure;"],"whatHappens":"If you join, the listed intervention(s) are YTS109. The registry lists allocation as na. An exploratory clinical study of the safety and how well it works of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 6 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.964Z"},{"nctId":"NCT06380751","title":"Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","officialTitle":"A Randomised, Open-Label, Phase III Study of Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With Physician's Choice CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant for the First-Line Treatment of Patients With BRCA1, BRCA2, or PALB2 Mutations and Hormone Receptor Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified) Advanced Breast Cancer (EvoPAR-Breast01)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer","conditions":["Advanced Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Saruparib (AZD5305)"},{"type":"DRUG","name":"Camizestrant"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Anastrozole"},{"type":"DRUG","name":"Exemestane"}],"enrollment":788,"startDate":"2024-08-01","completionDate":"2029-12-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult females, pre/peri-menopausal and/or post-menopausal, and adult males\n* Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer\n* Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease\n* ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks\n* FFPE tumour tissue from each participant\n* Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2\n* Adequate organ and marrow function\n\nExclusion Criteria:\n\n* Participants with history of MDS/AML or with features suggestive of MDS/AML\n* Participants with any known predisposition to bleeding\n* Any history of persisting severe cytopenia\n* Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections\n* Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection\n* History of another primary malignancy\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia\n* Spinal cord compression, brain metastases, carcinomatous meningitis, or leptomeningeal disease\n* Evidence of active and uncontrolled hepatitis B and/or hepatitis C\n* Evidence of active and uncontrolled HIV infection\n* Active tuberculosis infection\n* Cardiac criteria, including history of arrythmia and cardiovascular disease\n* Concurrent exogenous reproductive hormone therapy or non-topical hormonal therapy for non-cancer-related conditions\n* Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study\n* Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks before the first dose of study treatment\n* Prior treatment with systemic anti-cancer therapy for locoregionally recurrent or metastatic disease is not permitted, apart from treatment with ET for up to 28 days total before randomisation\n* Prior treatment within 28 days with blood product support or growth factor support\n* Any systemic concurrent anti-cancer treatment\n* Concomitant use of the following types of medications or herbal supplements within 21 days or at least 5 half-lives of randomisation:\n\n  1. Strong and moderate CYP3A4 inducers/inhibitors\n  2. Sensitive CYP2B6 substrates\n  3. Substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index, eg, warfarin (and other coumarin-derived vitamin K antagonist anticoagulants) and phenytoin.\n* Concomitant use of drugs that are known to prolong QT and have a known risk of TdP\n* Systemic use of atropine\n* The following exclusion criteria apply to treatments administered for early breast cancer:\n\n  1. Disease progression ≤ 84 days following the last dose of neo-adjuvant or adjuvant chemotherapy\n  2. Disease progression ≤ 1 year (365 days) from the last dose of treatment with a PARPi and/or platinum agent for early breast cancer\n  3. Disease progression ≤ 1 year (365 days) from the last dose with a CDK4/6i in the adjuvant setting\n  4. Disease progression ≤ 1 year (365 days) from the last dose of an oral SERD including camizestrant.","locations":[{"facility":"Research Site","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Grand 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2)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["gilbert-arizona","fountain-valley-california","glendale-california","los-angeles-california","newport-beach-california","aurora-colorado","grand-junction-colorado","hollywood-florida","jacksonville-florida","orlando-florida","arlington-heights-illinois","chicago-illinois","evanston-illinois","park-ridge-illinois","schaumburg-illinois","urbana-illinois","winfield-illinois","indianapolis-indiana","louisville-kentucky","baltimore-maryland","silver-spring-maryland","boston-massachusetts","dearborn-michigan","detroit-michigan","royal-oak-michigan","rochester-minnesota","saint-joseph-missouri","springfield-missouri","st-louis-missouri","camden-new-jersey","new-brunswick-new-jersey","brooklyn-new-york","mineola-new-york","new-hyde-park-new-york","new-york-new-york","shirley-new-york","stony-brook-new-york","the-bronx-new-york","westbury-new-york","hershey-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","west-columbia-south-carolina","chattanooga-tennessee","nashville-tennessee","houston-texas","san-antonio-texas","midlothian-virginia","norfolk-virginia","tacoma-washington","morgantown-west-virginia","milwaukee-wisconsin","ciudad-aut-noma-buenos-aires-argentina","ciudad-de-buenos-aires-argentina","c-rdoba-argentina","rosario-argentina","salta-argentina","san-miguel-de-tucum-n-argentina","darlinghurst-australia","malvern-australia","melbourne-australia","graz-austria","innsbruck-austria","linz-austria","vienna-austria","cachoeira-de-itapemirim-brazil","curitiba-brazil","fortaleza-brazil","goi-nia-brazil","ja-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","salvador-brazil","s-o-paulo-brazil","plovdiv-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","vratsa-bulgaria","toronto-canada","greenfield-park-canada","montreal-canada","saskatoon-canada","providencia-chile","recoleta-chile","santiago-chile","talca-chile","vi-a-del-mar-chile","beijing-china","bengbu-china","changchun-china","changsha-china","chengdu-china","chongqing-china","foshan-china","fuzhou-china","guangzhou-china","hangzhou-china","harbin-china","hefei-china","hohhot-china","jining-china","kunming-china","liuzhou-china","luoyang-china","nanchang-china","nanjing-china","shandong-china","shanghai-china","shenyang-china","shijiazhuang-china","tianjin-china","weifang-china","wuhan-china","xian-china","xiamen-china","xiangyang-china","xinxiang-china","zhengzhou-china","brno-czechia","ho-ovice-czechia","hradec-kr-lov-czechia","olomouc-czechia","prague-czechia","angers-france","besan-on-france","lille-france","lyon-france","marseille-france","paris-france","rouen-france","saint-herblain-france","toulouse-france","villejuif-france","aachen-germany","augsburg-germany","berlin-germany","cologne-germany","dessau-germany","d-sseldorf-germany","erlangen-germany","g-ttingen-germany","hamburg-germany","hanover-germany","heidelberg-germany","kiel-germany","leipzig-germany","ludwigsburg-germany","m-nchen-germany","m-nster-germany","witten-germany","hong-kong-hong-kong","budapest-hungary","debrecen-hungary","miskolc-hungary","zalaegerszeg-hungary","delhi-india","kolkata-india","lucknow-india","mumbai-india","mysuru-india","nagpur-india","nashik-india","new-delhi-india","surat-india","thiruvananthapuram-india","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","bergamo-italy","bologna-italy","milan-italy","modena-italy","naples-italy","padova-italy","reggio-emilia-italy","rome-italy","rozzano-italy","chiba-japan","hidaka-shi-japan","hirakata-shi-japan","isehara-shi-japan","kagoshima-japan","kashiwa-japan","k-toku-japan","kumamoto-japan","kyoto-japan","matsuyama-japan","nagoya-japan","osaka-japan","ota-shi-japan","sapporo-japan","sendai-japan","shinagawa-ku-japan","suita-shi-japan","sunto-gun-japan","takasaki-shi-japan","tsu-japan","yokohama-japan","bandar-puncak-alam-malaysia","johor-bahru-malaysia","kuala-lumpur-malaysia","kuala-selangor-malaysia","malacca-malaysia","bellavista-peru","jesus-maria-lima-peru","lima-peru","bia-a-podlaska-poland","koszalin-poland","lodz-poland","lublin-poland","poznan-poland","radom-poland","warsaw-poland","coimbra-portugal","lisbon-portugal","matosinhos-municipality-portugal","porto-portugal","vila-real-portugal","san-juan-puerto-rico","daegu-south-korea","seongnam-si-south-korea","seoul-south-korea","a-coru-a-spain","barcelona-spain","c-ceres-spain","granada-spain","lhospitalet-de-llobregat-spain","madrid-spain","m-laga-spain","pamplona-spain","seville-spain","valencia-spain","zaragoza-spain","new-taipei-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkok-thailand","dusit-thailand","hat-yai-thailand","muang-thailand","ratchathewi-thailand","adapazar-turkey-t-rkiye","alt-nda-ankara-turkey-t-rkiye","ankara-turkey-t-rkiye","ankaya-turkey-t-rkiye","istanbul-turkey-t-rkiye","kayseri-turkey-t-rkiye","cambridge-united-kingdom","guildford-united-kingdom","london-united-kingdom","manchester-united-kingdom","oxford-united-kingdom","swansea-united-kingdom","taunton-united-kingdom","truro-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Saruparib (AZD5305) for Advanced Breast Cancer","inPlainEnglish":"The primary objective of the study is to measure how well it works of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer","whoItsFor":["Ages 18 Years to any","Adult females, pre/peri-menopausal and/or post-menopausal, and adult males","Histologically or cytologically documented diagnosis of HR-positive, HER2-negative breast cancer","Advanced breast cancer with either locally advanced disease not amenable to curative treatment or metastatic disease","how well you can do daily activities (ECOG score) of 0 or 1 with no deterioration over the previous 2 weeks","FFPE tumour tissue from each participant","Documented germline tumour loss of function mutation in BRCA1, BRCA2, or PALB2","Adequate organ and marrow function"],"whoShouldSkip":["Participants with history of MDS/AML or with features suggestive of MDS/AML","Participants with any known predisposition to bleeding","Any history of persisting severe cytopenia","Any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections","Refractory nausea and vomiting, chronic GI disease, inability to swallow the formulated product, or previous significant bowel resection","History of another primary malignancy","Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anti-cancer therapy excluding alopecia"],"whatHappens":"If you join, the listed intervention(s) are Saruparib (AZD5305), Camizestrant, or Abemaciclib. The registry lists allocation as randomized. The primary objective of the study is to measure how well it works of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 788 people at 259 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.717Z"},{"nctId":"NCT06386315","title":"Reduced Dose Radiotherapy for the Treatment of Indolent Non-Hodgkin Lymphoma","officialTitle":"MC230808 Reduced Dose Hypofractionated Radiotherapy (3Gy x 3 Fractions) for Indolent Non-Hodgkin Lymphoma (POSEIDON): A Multisite Phase 2 Randomized Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Standard of care radiation treatment for indolent non-Hodgkin lymphoma is usually delivered in 12 treatments. Studies have shown indolent lymphoma to be sensitive to radiation treatment, however, larger doses have higher rates of toxicities. A reduced radiation dose may be safe, tolerable and/or effective compared to standard of care radiation dose in treating patients with indolent non-Hodgkin lymphoma.","conditions":["Indolent B-Cell Non-Hodgkin Lymphoma","Recurrent Indolent B-Cell Non-Hodgkin Lymphoma","Refractory Indolent B-Cell Non-Hodgkin Lymphoma","Recurrent Indolent Non-Hodgkin Lymphoma","Refractory Indolent Non-Hodgkin Lymphoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Endoscopic Procedure"},{"type":"RADIATION","name":"Involved-site Radiation Therapy (3 Fractions)"},{"type":"RADIATION","name":"Involved-site Radiation Therapy (12 Fractions)"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":112,"startDate":"2024-05-15","completionDate":"2029-05-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of indolent B-cell lymphoma that can include any of the following:\n\n  * Follicular lymphoma (grade 1 or 2 or 3A)\n  * Marginal zone lymphoma (nodal or extranodal)\n  * Follicle center lymphoma\n* Any stage disease\n* Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3\n* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willing to return to enrolling institution for follow-up visits (during the active monitoring phase of the study). Virtual visits can also be considered as an option for applicable items\n* Confirmation from radiation oncologist of suitability to participate in study\n\nExclusion Criteria:\n\n* Any of the following:\n\n  * Pregnant women\n  * Nursing women\n  * Women of childbearing potential who are unwilling to employ adequate contraception\n* T-cell lymphoma\n* Receiving treatment for small and chronic lymphocytic lymphoma\n* Grade 3B follicular lymphoma","locations":[{"facility":"Mayo Clinic in Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System in Albert Lea","city":"Albert Lea","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System - Mankato","city":"Mankato","state":"Minnesota","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System-Eau Claire Clinic","city":"Eau Claire","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Health System-Franciscan Healthcare","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Incidence of grade 2 or higher acute adverse events (AEs)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","jacksonville-florida","albert-lea-minnesota","mankato-minnesota","rochester-minnesota","eau-claire-wisconsin","la-crosse-wisconsin"],"enrichment":{"headline":"Phase 2: Computed Tomography for Indolent B-Cell Non-Hodgkin Lymphoma","inPlainEnglish":"This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors.","whoItsFor":["Ages 18 Years to any","Histological confirmation of indolent B-cell lymphoma that can include any of the following:","Follicular lymphoma (grade 1 or 2 or 3A)","Marginal zone lymphoma (nodal or extranodal)","Follicle center lymphoma","Initial, refractory, or relapsed disease. If relapse involves the site to be treated there must be evidence of disease progression","Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 3","Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only"],"whoShouldSkip":["Any of the following:","Women of childbearing potential who are unwilling to employ adequate contraception","Receiving treatment for small and chronic lymphocytic lymphoma","Grade 3B follicular lymphoma"],"whatHappens":"If you join, the listed intervention(s) are Computed Tomography, Endoscopic Procedure, or Involved-site Radiation Therapy (3 Fractions). The registry lists allocation as randomized. This phase II trial compares the safety, side effects and effectiveness of reduced dose radiation therapy to standard of care dose radiation in treating patients with indolent non-Hodgkin lymphoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 112 people at 7 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.145Z"},{"nctId":"NCT06387017","title":"Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway","officialTitle":"Prospective Multicenter Cohort Study to Validate Four Groups of Biomarkers for Assessing Lung Cancer Risk Among Patients With Atheromatous Cardiovascular Disease in a Screening Pathway","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Assistance Publique Hopitaux De Marseille","sponsorClass":"OTHER","summary":"Interventional study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.","conditions":["Smoking-related Pathology","Atheroma","Non-progressive Cancer > 5 Years","Lung Cancer"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"blood sampling"},{"type":"DIAGNOSTIC_TEST","name":"stool collection"},{"type":"RADIATION","name":"low dose CT scan"}],"enrollment":750,"startDate":"2024-04-02","completionDate":"2028-07","sex":"ALL","minAge":"45 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1- All PREVALUNG or PREVALUNG ETOILE participants\n* 2- Active or former smokers who have smoked daily for at least 10 years and have either atheromatous disease (coronary, lower limb, supra-aortic trunk, aortic, visceral or upper limb arteries) or a moderate or high coronary calcium score\\*, \\*\\*.\n\nInclusion criteria:\n\n* Age 45- 75 years and\n* Medical follow-up for smoking-related atheromatous pathology and\n* daily smoking for at least 10 years prior to disease (for smoking, there are no quantitative criteria or withdrawal times)\n\n  * visual coronary calcium score quantified by a radiologist on a chest CT scan.\n\n    3- Individuals at risk of lung cancer without atheromatous disease or moderate or high calcium score being managed for a tobacco-related disease (chronic bronchitis or non-progressive cancer \\> 5 years) or with eligibility criteria for lung cancer screening (inclusion criteria in the NLST or NELSON studies or American recommendations)\\*\\*.\n\nInclusion criteria :\n\n* Age 45- 75 and\n* Medical follow-up for a smoking-related pathology:\n* chronic obstructive pulmonary disease / emphysema, or\n* history of non-progressive cancer \\> 5 years, including ENT, lung, breast, cervix, excreto-urinary tract, bladder, esophagus, stomach, pancreas, liver, kidney, chronic myeloid leukemia.\n\nand\n\n\\- daily smoking for at least 10 years prior to the disease (for smoking, there are no quantitative criteria or withdrawal periods).\n\nOr\n\nInclusion criteria in NLST :\n\n* Age 55 - 74\n* Cumulative smoking ≥ 30 pack-years\n* active or weaned for less than 15 years Or\n\nNELSON inclusion criteria :\n\n* Age 50-75\n* Smoking :\n* \\> 15 cigarettes /D for more than 25 years or\n* \\> 10 cigarettes /D for more than 30 years\n* active smoking or cessation \\< 10 years Or\n\nAmerican recommendations :\n\n* Age 50 - 80\n* Smoking ≥20 PA\n\nExclusion Criteria:\n\n* cancer history \\< 5 years (except carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin, non-invasive urothelial carcinoma treated for curative purposes without CT lung surveillance, prostate cancer with unmeasurable PSA)\n* symptoms of lung cancer (involuntary weight loss \\> 7 kg in 1 year, hemoptysis)\n* known history of pulmonary nodule requiring specialized follow-up\n* history of pulmonary fibrosis or pulmonary hypertension\n* active pulmonary parenchymal infection\n* severe cardiac or respiratory insufficiency (rest dyspnea)\n* performance status (WHO) 2, 3 or 4\n* patient not affiliated to the social security system (beneficiary or beneficiary's beneficiary)\n* patient deprived of liberty\n* patients under guardianship or trusteeship\n* pregnant or breast-feeding women","locations":[{"facility":"Assistance Publique Hopitaux de Marseille","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David BOULATE, Pr","phone":"+33491966018","email":"david.boulate@ap-hm.fr"}],"primaryOutcomes":["biomarker group validation"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["marseille-france"],"enrichment":{"headline":"Not a traditional drug phase: blood sampling for Smoking-related Pathology","inPlainEnglish":"Treatment study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.","whoItsFor":["Ages 45 Years to 80 Years","1- All PREVALUNG or PREVALUNG ETOILE participants","2- Active or former smokers who have smoked daily for at least 10 years and have either atheromatous disease (coronary, lower limb, supra-aortic trunk, aortic, visceral or upper limb arteries) or a moderate or high coronary calcium score\\*, \\*\\*","who can join:","Age 45- 75 years and","Medical follow-up for smoking-related atheromatous pathology and","daily smoking for at least 10 years prior to disease (for smoking, there are no quantitative criteria or withdrawal times)","visual coronary calcium score quantified by a radiologist on a chest CT scan"],"whoShouldSkip":["cancer history \\< 5 years (except carcinoma in situ of the uterine cervix, basal cell carcinoma of the skin, non-invasive urothelial carcinoma treated for curative purposes without CT lung surveillance, prostate cancer with unmeasurable PSA)","symptoms of lung cancer (involuntary weight loss \\> 7 kg in 1 year, hemoptysis)","known history of pulmonary nodule requiring specialized follow-up","history of pulmonary fibrosis or pulmonary hypertension","active pulmonary parenchymal infection","severe cardiac or respiratory insufficiency (rest dyspnea)","performance status (WHO) 2, 3 or 4"],"whatHappens":"If you join, the listed intervention(s) are blood sampling, stool collection, or low dose CT scan. The registry lists allocation as na. Treatment study with minimal risks and constraints, with evaluation of the incidence of lung cancers by low-dose thoracic CT scan without injection of contrast medium, of the immunological, inflammatory and metabolic blood profile and of the microbiota; systematic proposal of smoking cessation for active smokers or assistance in maintaining cessation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 750 people at Marseille. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.708Z"},{"nctId":"NCT06389019","title":"Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer","officialTitle":"Whole-slide Image and CT Radiomics Based Deep Learning System for Prognostication Prediction in Bladder Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mingzhao Xiao","sponsorClass":"OTHER","summary":"Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis. In this research, we aim to develop a deep learning-based prognostic-stratification system for automatic prediction of overall and cancer-specific survival in patients with BLCA.This observational study evaluates a deep learning system that combines CT images and digitized pathology slides to predict outcomes in patients with bladder cancer. It includes a retrospective cohort and a prospective cohort of newly enrolled patients. The prospective cohort will assess the system in patients enrolled during (2024-2026), with follow-up for survival and recurrence.","conditions":["Bladder Cancer"],"keywords":["deep learning","Radiomics","Histopathological tissue slides","Tomography"],"interventions":[{"type":"OTHER","name":"Deep learning system for prognostication prediction in bladder cancer"}],"enrollment":2000,"startDate":"2024-01-01","completionDate":"2027-12-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients with bladder cancer who had surgery like radical cystectomy or transurethral resection of bladder tumour (TURBT)\n* contrast-CT scan less than two weeks before surgery\n* complete CT image data and clinical data\n* complete whole slide image data\n\nExclusion Criteria:\n\n* patients with a postoperative diagnosis of non-urothelial carcinoma\n* poor quality of CT images","locations":[{"facility":"Department of Urology, The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"QuanHao He","phone":"800-555-5555","email":"2020120460@stu.cqmu.edu.cn"},{"name":"Mingzhao Xiao, PHD","phone":"800-555-5555","email":"2023140134@stu.cqmu.edu.cn"}],"primaryOutcomes":["Overall survival"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["chongqing-china"],"enrichment":{"headline":"Not a traditional drug phase: Deep learning system for prognostication prediction in bladder cancer for Bladder Cancer","inPlainEnglish":"Bladder cancer (BLCA), with its diverse histopathological features and varying patient outcomes, poses significant challenges in diagnosis and prognosis. Postoperative survival stratification based on radiomics feature and whole slide image feature may be useful for treatment decisions to improve prognosis.","whoItsFor":["patients with bladder cancer who had surgery like radical cystectomy or transurethral resection of bladder tumour (TURBT)","contrast-CT scan less than two weeks before surgery","complete CT image data and clinical data","complete whole slide image data"],"whoShouldSkip":["patients with a postoperative diagnosis of non-urothelial carcinoma","poor quality of CT images"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Chongqing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.290Z"},{"nctId":"NCT06391554","title":"Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis","officialTitle":"Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Aarhus","sponsorClass":"OTHER","summary":"The EDUEX trial will determine whether the addition of progressive resistance training (PRT) to a patient education program (EDU) will improve clinical outcomes in patients with hip OA.\n\nIn a subsample, the effect of PRT on the articular cartilage and other structures of the hip joint is investigated. In this subsample, a comprehensive assessment of possible mechanisms underlying the effects of exercise on pain and function is undertaken.\n\nThe EduEx trial will be a multicentre, stratified (by site), block randomized (allocation 1:1), controlled, parallel-group superiority trial. 150 people with hip OA will be recruited from hospitals, physiotherapy clinics, social media and newspapers. Participants will be randomized to PRT and EDU or EDU alone. All 150 participants will be included in the clinical evaluation study (CLIN). The last 40 participants randomized to PRT+EDU and to EDU, respectively, will also be included in the mechanistic (MECH) evaluation study (n=80), by being asked to participate in additional outcome assessments. The primary endpoint will be the 12 months follow-up for both the CLIN and MECH study, while a secondary endpoint will be the 3-month follow-up.","conditions":["Hip Osteoarthritis"],"keywords":[],"interventions":[{"type":"OTHER","name":"PRT"},{"type":"OTHER","name":"EDU"}],"enrollment":150,"startDate":"2024-05-01","completionDate":"2027-12-01","sex":"ALL","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Clinically diagnosed with hip OA according to the criteria by the National Institute for Health and Care Excellence (NICE)\n* Radiographic verification of hip OA diagnosis with Kellgren Lawrence score of 2 or 3 in one or both hips\n* Not scheduled for a total hip replacement within the following 12 months\n* An event of hip pain every day of at least 3 out of 10 on a numerical rating scale during the last 14 days\n* Age ≥ 45 years\n* Adequacy in written and spoken Danish\n\nExclusion Criteria:\n\n* Comorbidity that markedly influences hip function or degeneration of tissue in or around the hip joint (rheumatic, neurological, mental or other)\n* Surgery in the lower extremities within the six months prior to inclusion\n* BMI \\> 40\n* Pregnancy\n* Resistance exercise (weights or elastic bands) for the lower extremities exceeding 12 sessions over the last 6 months or 6 sessions over the last 3 months\n* Suffering from claustrophobia or not tolerating whole body MRI scanner\n* Metallic implants from the waist to just above the knee\n* Pacemaker or other medical devices that are not MR approved","locations":[{"facility":"Aarhus University","city":"Aarhus C","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aarhus University Hospital","city":"Aarhus N","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Troels Kjeldsen, MSc","phone":"4560137627","email":"tkjeldsen@clin.au.dk"},{"name":"Thomas Frydendal, PhD","phone":"4525614618","email":"thomas.frydendal@clin.au.dk"}],"primaryOutcomes":["Changes from baseline to 12 month follow-up (primary endpoint) in the Hip Disability and Osteoarthritis Outcome Score (HOOS) ADL function subscale","Changes from baseline to 12-month follow-up (primary endpoint) in the hip articular cartilage of the index hip measured by MRI T2 relaxation time mapping."],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["aarhus-c-denmark","aarhus-n-denmark"],"enrichment":{"headline":"Not a traditional drug phase: PRT for Hip Osteoarthritis","inPlainEnglish":"The EDUEX trial will determine whether the addition of progressive resistance training (PRT) to a patient education program (EDU) will improve clinical outcomes in patients with hip OA. In a subsample, the effect of PRT on the articular cartilage and other structures of the hip joint is investigated.","whoItsFor":["Ages 45 Years to any","Clinically diagnosed with hip OA according to the criteria by the National Institute for Health and Care Excellence (NICE)","Radiographic verification of hip OA diagnosis with Kellgren Lawrence score of 2 or 3 in one or both hips","Not scheduled for a total hip replacement within the following 12 months","An event of hip pain every day of at least 3 out of 10 on a numerical rating scale during the last 14 days","Adequacy in written and spoken Danish"],"whoShouldSkip":["Comorbidity that markedly influences hip function or degeneration of tissue in or around the hip joint (rheumatic, neurological, mental or other)","Surgery in the lower extremities within the six months prior to inclusion","Resistance exercise (weights or elastic bands) for the lower extremities exceeding 12 sessions over the last 6 months or 6 sessions over the last 3 months","Suffering from claustrophobia or not tolerating whole body MRI scanner","Metallic implants from the waist to just above the knee","Pacemaker or other medical devices that are not MR approved"],"whatHappens":"If you join, the listed intervention(s) are PRT, or EDU. The registry lists allocation as randomized. The EDUEX trial will determine whether the addition of progressive resistance training (PRT) to a patient education program (EDU) will improve clinical outcomes in patients with hip OA.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.515Z"},{"nctId":"NCT06394284","title":"Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and Moral Injury","officialTitle":"IISPT2: Examining 3,4-methylenedioxymethamphetamine (MDMA) Effects on Psychological, Relational and Hyperarousal-Related Neural Reactivity Mechanisms in Veterans With PTSD and MI","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Herzog Hospital","sponsorClass":"OTHER","summary":"Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population. Additionally, even in groups where participants receive a placebo, the effect of the psychedelic treatment formulation, intensive, focused and respectful structure, appears to have promising effects. Indeed, in the current psychedelic literature, the setting and mind with which participant approach psychedelic therapy, significantly contributes to the treatment effect.\n\nThe current study proposes to address the major gaps in the theoretical literature by examining the proposed mechanisms by which MDMA enhances the \"window of tolerance\" for PTSD therapy, specifically in those with comorbid symptoms of moral injury; namely by reducing hyperarousal and enhancing connection (to self and others) and whether MDMA assisted therapy is more successful in reducing PTSD in veterans compared to a matched somatic experiential PTSD treatment, Somatic Experiental Acceptance Intensive Trauma-based therapy, (SEA-IT) which builds upon the promising placebo results, enhancing them with somatic and acceptance based treatment protocols.","conditions":["PTSD, Post Traumatic Stress Disorder","Moral Injury"],"keywords":["MDMA","PTSD","Moral Injury","Oxytocin","veterans","Hyperarousal"],"interventions":[{"type":"DRUG","name":"MDMA-AT"},{"type":"BEHAVIORAL","name":"SEA-IT"}],"enrollment":60,"startDate":"2024-05-20","completionDate":"2027-12-31","sex":"MALE","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Were assigned male sex at birth and currently identify as a male (e.g. are not transgender nor taking hormone replacement therapy) 2. Are veterans of the Israeli military 3. Are at least 18 years old. 4. Are fluent in speaking and reading Hebrew 5. Are able to swallow pills. 6. Agree to have EEG (three times) and salivary monitoring (during experimental sessions) at multiple occasions throughout the study.\n\n  7\\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions.\n\n  8\\. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable.\n\n  8\\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n\n  9\\. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to experimental sessions, not enroll in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.\n\nMedical History\n\n10\\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at psychiatric or psychological treatment.\n\n11\\. At Screening, have a PCL-5 total score of 33 or greater and at Screening/Baseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater.\n\n12\\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (BMI) within the range of 18 to 30 kg/m2.\n\n13\\. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n\\- Medical Conditions\n\n1. Alanine transaminase (ALT) \\[or aspartate transaminase (AST)\\]higher than 2 x upper limit of normal (ULN).\n2. Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%).\n3. Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n\n   • Note: Stable chronic liver disease (including Gilbert's syndrome, asymptomatic gallstones, and chronic stable hepatitis B (e.g., the presence of hepatitis B surface antigen or positive hepatitis C antibody test result without evidence of active infection at screening or within 3 months prior to starting study intervention) is acceptable if the participant otherwise meets entry criteria.\n4. Have a recent history of clinically significant hyponatremia or hyperthermia.\n5. Have a marked baseline QTcF (QT interval corrected for heart rate ) interval higher than 450 ms demonstrated on repeated ECG (electrocardiogram) assessments. Participants whose QTcF exceeds this value during screening may be initially enrolled if a pre-study concomitant medication is suspected to be prolonging the QT-interval. ECGs should be repeated after initial enrollment and tapering off the pre-study concomitant medication to ensure the participant meets eligibility criteria prior to enrolment confirmation and to IMP dosing.\n\n   • Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read.\n6. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, heart failure, severe coronary artery disease, or aneurysm.\n\n   * Participants with other mild, stable chronic medical problems may be enrolled if the study clinician and Sponsor Investigator (S-I) agree the condition would not significantly increase the risk of MDMA administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of MDMA.\n   * Examples of stable medical conditions that could be allowed include but are not limited to human immunodeficiency virus (HIV) infection, gastroesophageal reflux disease (GERD), hypothyroidism (if taking adequate and stable thyroid replacement medication), glaucoma (if approval for study participation is received from an ophthalmologist). Any medical disorder judged by the investigator to significantly increase the risk of harm from MDMA exposure by any mechanism would require exclusion.\n7. Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated.\n\n   • Participants with well-controlled hypertension that has been successfully treated with anti-hypertensive medicines may be enrolled if they pass a risk assessment and potentially additional screening to rule out underlying cardiovascular disease.\n8. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n9. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n10. Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n    • Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, as confirmed by a cardiologist.\n11. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).\n\n    Psychiatric Conditions (for MDMA-AT and somatic-based arms)\n12. Have engaged in a new form of psychiatric or mental health care within 12 weeks of enrollment, including Electroconvulsive Therapy (ECT), and ketamine-assisted therapy.\n13. Are likely, in the investigator's opinion and via observation during the Preparatory Period, to be re-exposed to their index trauma or other significant trauma during the study.\n14. Have a current moderate (not in early remission in the 3 months prior to enrollment and meets at least 5 of 11 diagnostic criteria per DSM-5) or severe alcohol or cannabis use disorder within the 12 months prior to enrollment (meets at least 6 of 11 diagnostic criteria per DSM-5).\n\n    • May have current mild alcohol or cannabis use disorder (meets 3 of 11 diagnostic criteria per DSM-5) or moderate alcohol or cannabis use disorder in early remission for the 3 months prior to enrollment (meets 4 or 5 of 11 diagnostic criteria per DSM-5).\n15. Have an active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.\n16. Any participant presenting current serious suicide risk, as determined through psychiatric interview, responses to Columbia Suicide Severity Rating Scale (C-SSRS), and clinical judgment of the investigator will be excluded; however, history of suicide attempts is not an exclusion. Any participant who is likely to require hospitalization related to suicidal ideation and behavior, in the judgment of the investigator, will not be enrolled. Any participant presenting with the following on the Baseline/Screening C-SSRS will be excluded:\n\n    * Suicidal ideation score of 4 or greater within the last month of the assessment at a frequency of once a week or more.\n    * Suicidal ideation score of 5 within the last 6 months of the assessment.\n    * Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment. Participants with non-suicidal self-injurious behavior may be included if approved by the study clinician.\n\n    Prior/Concomitant Therapy\n17. Unable or unwilling to safely taper-off prohibited psychiatric medication with exceptions described in section on Concomitant Medications in study protocol or require use of prohibited medications during experimental sessions.\n18. Require use of concomitant medications that could prolong the QT interval during Experimental Sessions.\n19. Have used Ecstasy (unregulated material represented as containing MDMA) more than 10 times within the last 10 years, or at least once within 6 months of the first Experimental Session.\n\n    Prior/Concurrent Clinical Study Experience\n20. Current enrollment in any other clinical study involving an investigational study treatment or any other type of medical research, unless approved by the study clinician.\n\n    Diagnostic Assessments\n21. Have current Personality Disorders assessed via psychiatric assessment (by consultant psychiatrist).\n22. Have a current eating disorder with compensatory behaviors\n23. Have current major depressive disorder with psychotic features\n24. Have a history of, or a current primary psychotic disorder, bipolar affective disorder type 1 or dissociative identity disorder.\n\n    Other Exclusions\n25. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.\n26. Are currently engaged in compensation litigation whereby financial gain would be achieved from prolonged symptoms of PTSD or any other psychiatric disorders.\n27. Lack social support or lack a stable living situation.\n28. Previous participation in a MAPS-sponsored MDMA clinical trial.\n29. Employees (and their immediate family members) of MAPS, MAPS Public Benefit Corporation, or MAPS Europe B.V; or individuals in a personal relationship with the site investigator.\n30. Have any current problem which, in the opinion of the sponsor-investigator or study clinician, might interfere with study participation.\n\nSecurity Criteria\n\nThe current study dealing with intensive treatment of military veterans suffering from PTSD, requires an environment of physical and emotional security for the patients. Safety is critical in the success of the treatment. Since October 7, 2023, we have been in a continuous state of war, which we do not know when it will end. Therefore, we are required at this time to define what security is as a criterion for conducting research at this time, and in relation to the normative reality in the world and in the State of Israel in particular. Therefore:\n\n1. The research will be carried out in Jerusalem and long sessions will not take place when there is a high risk of rocket attack or sirens during the previous day/night.\n2. The participants in the study will be military veterans who do not participate or have taken an operational part in the war in the three months prior to the start of their participation in the study.\n3. The participants in the study do not have first degree relatives or a partner who are actively serving in a war zone at the time of their participation in the study.\n4. The participants live in a permanent and safe place and are not expected to change their place of residence during their participation in the study.","locations":[{"facility":"METIV Israel Psychotrauma Center, Herzog Medical Center","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sharon Bar Dov","phone":"009225952234","email":"Sharonb@metiv.org"}],"primaryOutcomes":["PTSD","Oxytocin"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["jerusalem-israel"],"enrichment":{"headline":"Phase 3: testing MDMA-AT for PTSD, Post Traumatic Stress Disorder","inPlainEnglish":"Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments. In recent years 3,4-methylenedioxymethamphetamine (MDMA), a psychedelic drug has demonstrated a significant treatment potential for severe and treatment resistant PTSD though not specifically in a veteran population.","whoItsFor":["Men only","7\\. Agree to have study visits recorded, including Experimental Sessions, Independent Rater assessments, and non-drug therapy sessions","8\\. Must provide a contact (relative, spouse, close friend or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming unwell or unreachable","8\\. Must agree to inform the investigators within 48 hours of any medical conditions and procedures","10\\. At Screening, meet diagnostic criteria (Diagnostic Statisticians Manual, 5th version, DSM-5) for current military-based PTSD with a symptom duration of 6 months or longer with a history of at least one attempt at psychiatric or psychological treatment","11\\. At Screening, have a PCL-5 total score of 33 or greater and at Screening/Baseline a confirmed diagnosis of PTSD per CAPS-5 and a total severity score of 28 or greater","12\\. Have a body weight of at least 45 kilograms. Participants with a body weight of 45 to 48 kg must also have a body mass index (body-mass index (BMI)) within the range of 18 to 30 kg/m2"],"whoShouldSkip":["\\- Medical Conditions","Alanine transaminase (ALT) \\[or aspartate transaminase (AST)\\]higher than 2 x upper limit of normal (ULN)","Total bilirubin higher than 1.5 x ULN (isolated bilirubin higher than; 1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin less than; 35%)","Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis","Have a recent history of clinically significant hyponatremia or hyperthermia","Note: The QTcF is the QT interval corrected for heart rate according to Fridericia's formula. It is either machine-read or manually over-read","Have a diagnosis of uncontrolled hypertension, defined as repeated blood pressure readings of ≥140 mmHg systolic or ≥90 mmHg diastolic. The diagnosis may be confirmed by repeated clinic measurements or home blood pressure monitoring if clinically indicated"],"whatHappens":"If you join, the listed intervention(s) are MDMA-AT, or SEA-IT. The registry lists allocation as randomized. Despite being exposed to a high level of potentially traumatic experiences due to exposure to combat, military veterans have poor response rates to traditional PTSD treatments, in some reports, just 1/3 of veterans recover using traditional treatments.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 60 people at Jerusalem. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.410Z"},{"nctId":"NCT06399432","title":"Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors","officialTitle":"Mediterranean Diet vs no Dietary Intervention for Improving Signs and Symptoms of Psoriasis in Patients Treated With Anti-IL-17 or Anti-IL-23 Inhibitors","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospitals Cleveland Medical Center","sponsorClass":"OTHER","summary":"In this study, participants will have 3 or 4 total study visits over approximately 10 total weeks. There is a two week medication washout period in between the 1st and 2nd visits. This washout only applies if participants are using a prohibited psoriasis medication (such as topical steroids or oral psoriasis medications, like methotrexate). During the washout period, participants will have to stop the prohibited medication(s). If participants are not using any prohibited medications, then the 1st and 2nd visits can be combined and participants will only have 3 total in-person visits. Participants will be randomly assigned (by chance; like flipping a coin) to either the Mediterranean Diet or no dietary intervention. After 4 weeks on the diet, participants will start treatment with either Anti-IL-17 or Anti-IL-23 therapy. The biologic treatments will prescribed by the participants regular dermatologist and not as a part of the study.","conditions":["Psoriasis"],"keywords":["risankizumab","tildrakizumab","brodalumab","izekizumab","secukinumab","guselkumab"],"interventions":[{"type":"BEHAVIORAL","name":"Mediterranean Diet"}],"enrollment":36,"startDate":"2022-10-18","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":"94 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening.\n* Have moderate to severe plaque psoriasis at Baseline as defined by\n\n  1. BSA ≥5% OR\n  2. sPGA ≥3 (moderate to severe) OR\n  3. PASI ≥5\n* Must have been prescribed, per standard-of-care, an Anti-IL-17 or Anti-IL-23 therapy for psoriasis, which the patient has not yet started, but is willing to start during the study.\n\nEligible therapies are Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, and Tildrakizumab.\n\n* Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination.\n* Must be eligible for a weight loss program, defined as being in good general health and having a BMI between 25 to 40.\n\nExclusion Criteria:\n\n* Other than psoriasis, history of any clinically significant (as determined by the Investigator) cardiac (clinically advanced cardiovascular disease including stent, past history of MI, thrombotic event or arterial calcification), active or history of inflammatory bowel disease, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.\n* Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.\n* Any condition, including other inflammatory diseases or dermatologic conditions that confound the ability to interpret data from the study.\n* Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.\n* Pregnant or breast-feeding.\n* Have failed more than 3 systemic agents for treatment of psoriasis.\n* History of allergy to any component of Anti-IL-17 or Anti-IL-23 therapies.\n* Had a serious infection (including, but not limited to, hepatitis, pneumonia, sepsis, cellulitis, meningitis or pyelonephritis) or have been hospitalized for an infection. Subject must be cured of infection \\> 4 weeks before Screening.\n* Have a history of, or ongoing, chronic or recurrent infectious disease, including, but not limited to, chronic renal infection, chronic chest infection (e.g., bronchiectasis), sinusitis, recurrent urinary tract infection (e.g., recurrent pyelonephritis, chronic non-remitting cystitis), an open, draining, or infected skin wound or ulcer.\n* Had a Bacillus Calmette-Guérin (BCG) vaccination within 1 year prior to screening.\n* History of positive human immunodeficiency virus (HIV), or have congenital or acquired immunodeficiency (e.g., common variable immunodeficiency disease).\n* Active substance abuse or a history of substance abuse within 6 months prior to Screening.\n* Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment and cure for such infections must have been completed at least 4 weeks prior to Screening.\n* Malignancy or history of malignancy, except for:\n\n  1. treated \\[i.e., cured\\] basal cell or squamous cell in situ skin carcinomas;\n  2. treated \\[i.e., cured\\] cervical intraepithelial neoplasia \\[CIN\\] or carcinoma in situ of the cervix with no evidence of recurrence within the previous 5 years.\n* Have a known nut allergy.\n* Currently participating in a supervised dietary program.\n* Use of psoriasis therapy 2 weeks prior to Baseline (including, but not limited to, topical corticosteroids, retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, anthralin/dithranol, cyclosporine, corticosteroids, methotrexate, retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, sulfasalazine, azathioprine, fumaric acid esters, TNF inhibitors IL-17 inhibitors, IL-12/23 inhibitors, or phototherapy).\n\nExceptions: Low-potency corticosteroids will be allowed as background therapy and restricted to treatment of the face, axillae, and groin in accordance with the manufacturers' suggested usage during the course of the study (this restricted usage should be documented). Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. An unmedicated skin moisturizer (e.g. Eucerin®) will be also permitted for body lesions only. Subjects should not use these topical treatments within 24 hours prior to the clinic visit.\n\n* Use of any investigational drug within 2 weeks prior to Baseline.\n* Prolonged sun exposure or use of tanning booths or other ultraviolet (UV) light sources.\n* Currently flaring or unstable psoriasis.","locations":[{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kym Warner","phone":"216-844-7546","email":"Kymberlyn.Warner@UHhospitals.org"}],"primaryOutcomes":["Percentage of participants who had a change in blood monocytes profiles.","Percentage of participants who had a change in T-cell profiles.","Change in blood monocyte profile.","Change in T-cell profiles."],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":["risankizumab"],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Mediterranean Diet for Psoriasis","inPlainEnglish":"In this study, participants will have 3 or 4 total study visits over approximately 10 total weeks. There is a two week medication washout period in between the 1st and 2nd visits.","whoItsFor":["Ages 18 Years to 94 Years","Diagnosis of chronic plaque psoriasis for at least 12 months prior to Screening","Have moderate to severe plaque psoriasis at Baseline as defined by","sPGA ≥3 (moderate to severe) OR","Must have been prescribed, per standard-of-care, an Anti-IL-17 or Anti-IL-23 therapy for psoriasis, which the patient has not yet started, but is willing to start during the study","Eligible therapies are Secukinumab, Ixekizumab, Brodalumab, Guselkumab, Risankizumab, and Tildrakizumab","Must be in good health (except for psoriasis) as judged by the Investigator, based on medical history and physical examination","Must be eligible for a weight loss program, defined as being in good general health and having a body-mass index (BMI) between 25 to 40"],"whoShouldSkip":["Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study","Any condition, including other inflammatory diseases or dermatologic conditions that confound the ability to interpret data from the study","Prior history of suicide attempt at any time in the subject's lifetime prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years","Pregnant or breast-feeding","Have failed more than 3 systemic agents for treatment of psoriasis","History of allergy to any component of Anti-IL-17 or Anti-IL-23 therapies","Had a serious infection (including, but not limited to, hepatitis, pneumonia, sepsis, cellulitis, meningitis or pyelonephritis) or have been hospitalized for an infection. Subject must be cured of infection \\> 4 weeks before Screening"],"whatHappens":"If you join, the listed intervention(s) are Mediterranean Diet. The registry lists allocation as randomized. In this study, participants will have 3 or 4 total study visits over approximately 10 total weeks.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at Cleveland. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.578Z"},{"nctId":"NCT06400472","title":"A Study of Sofe-M in Participants With Selected Advanced Solid Tumors","officialTitle":"A First-in-Human, Phase 1/2 Trial to Assess the Safety, Tolerability and Preliminary Efficacy of Sofetabart Mipitecan (LY4170156), an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.","conditions":["Ovarian Neoplasms","Endometrial Neoplasms","Uterine Cervical Neoplasms","Carcinoma, Non-Small-Cell Lung","Triple Negative Breast Neoplasms","Pancreatic Neoplasm","Colorectal Neoplasms"],"keywords":["Folate receptor alpha","NSCLC","Ovarian cancer","Cervical cancer","Endometrial cancer","Solid tumor","Lung cancer","Breast cancer","Pancreatic cancer","Colorectal cancer","Anti-drug conjugate","Phase I","Chemotherapy","sofe-m"],"interventions":[{"type":"DRUG","name":"Sofe-M"},{"type":"DRUG","name":"bevacizumab"},{"type":"DRUG","name":"carboplatin"},{"type":"DRUG","name":"Itraconazole"},{"type":"DRUG","name":"pembrolizumab"}],"enrollment":575,"startDate":"2024-05-20","completionDate":"2029-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)\n  * Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer\n  * Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, TNBC, and high grade endometrioid cancer\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled central nervous system (CNS) metastases\n* Individual with history of carcinomatous meningitis\n* Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection\n* Individual with evidence of corneal keratopathy or history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)\n* History of pneumonitis/interstitial lung disease\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention","locations":[{"facility":"HonorHealth","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego (UCSD) - Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START) Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health - Long Island","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University (NYU) Clinical Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University (OSU) Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas - MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute","city":"Falls Church","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cancer Research SA","city":"Adelaide","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icon Cancer Centre South Brisbane","city":"QLD","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Leon Berard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancerologie de l'Ouest - site St-Herblain","city":"Saint-Herblain","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncopole Claudius Regaud","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Humanitas San Pio X","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Europeo di Oncologia","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Shizuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Institute Hospital of JFCR","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center","city":"Goyang-si Gyeonggi-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Phase 1a: To determine the recommended phase 2 dose (RP2D) of Sofe-M (LY4170156)","Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with bevacizumab","Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with carboplatin","Phase 1a: To determine the RP2D or optimal dose of Sofe-M (LY4170156) with pembrolizumab","Phase 1b: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: Overall response rate (ORR)","Phase 2: To assess the antitumor activity of Sofe-M (LY4170156) Monotherapy: ORR","Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","pancreatic-cancer","ovarian-cancer","cervical-cancer","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["scottsdale-arizona","la-jolla-california","atlanta-georgia","grand-rapids-michigan","mineola-new-york","new-york-new-york","columbus-ohio","houston-texas","west-valley-city-utah","falls-church-virginia","adelaide-australia","qld-australia","lyon-france","saint-herblain-france","toulouse-france","milan-italy","shizuoka-japan","tokyo-japan","goyang-si-gyeonggi-do-south-korea","barcelona-spain","madrid-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing Sofe-M for Ovarian Neoplasms","inPlainEnglish":"This study wants to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion).","whoItsFor":["Ages 18 Years to any","Have one of the following solid tumor cancers:","Dose Escalation: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)","Dose Optimization: Ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) and endometrial cancer","Dose Expansion: Low grade serous ovarian cancer, cervical cancer, NSCLC, TNBC, and high grade endometrioid cancer"],"whoShouldSkip":["Individual with known or suspected uncontrolled central nervous system (CNS) metastases","Individual with history of carcinomatous meningitis","Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection","Individual with evidence of corneal keratopathy or history of corneal transplant","Any serious unresolved toxicities from prior therapy","Significant cardiovascular disease","Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)"],"whatHappens":"If you join, the listed intervention(s) are Sofe-M, bevacizumab, or carboplatin. The registry lists allocation as randomized. This study wants to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 575 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.697Z"},{"nctId":"NCT06402617","title":"Ablation of Focal Activation in Atrial Fibrillation","officialTitle":"Ablation of Focal Activation During Persistent Atrial Fibrillation to Determine the Characteristics of Focal Drivers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Imperial College London","sponsorClass":"OTHER","summary":"Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF). However, it has not been possible to show similar focal drivers during AF, owing to the limitations of mapping in persistent AF. RETRO-Mapping has been developed as a method to generate activation maps during AF to test the hypothesis that persistent AF is also maintained by focal drivers.\n\nRETRO-Mapping is able to locate sites of focal activation that were isolated, intermittent, or recurrent during persistent AF. However, a 30-second segment of AF can have approximately 150 wavefronts in a small area of myocardium. Screening for focal activation and manually validating these prior to ablation was not feasible using current commercial systems.\n\nRETRO-Mapping can automatically detect focal activation and a recording system that enables the intracardiac signals to be directly analysed by the RETRO-Mapping software. This will allow RETRO-Mapping to build a detailed classification of focal activation types and study the impact of ablation of these sites on the AF cycle length, to address the hypothesis that persistent AF is maintained by focal drivers.","conditions":["Atrial Fibrillation","Atrial Fibrillation, Persistent","Arrhythmia","Arrhythmias, Cardiac","Cardiac Arrhythmia"],"keywords":["ablation","electrophysiology","mapping","local activation time","pulmonary vein isolation","atrial fibrillation cycle length"],"interventions":[{"type":"PROCEDURE","name":"Pulmonary vein isolation"},{"type":"DIAGNOSTIC_TEST","name":"RETRO-Mapping without adjunctive ablation"},{"type":"PROCEDURE","name":"Adjunctive ablation guided by RETRO-Mapping"}],"enrollment":110,"startDate":"2024-04-30","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Persistent atrial fibrillation with clinical indication for catheter ablation\n* Clinically suitable candidate for catheter ablation\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous atrial fibrillation or other catheter ablation procedure\n* Clinical contraindication to catheter ablation or general anaesthetic, including history of adverse reaction to contrast media, or presence of intracardiac thrombus, or inadequate anticoagulation in the preceding 6 weeks\n* Valvular disease graded moderate or greater, or presence of a prosthetic valve\n* Moderate-to-severe heart failure, defined as left ventricular ejection fraction \\<35% and/or New York Heart Association class III-IV\n* Any form of cardiomyopathy\n* Active infection or fever\n* Severe cerebrovascular disease\n* Active gastrointestinal bleeding\n* Bleeding or clotting disorders, clinically high bleeding risk, or clinical contraindication to receiving heparin\n* Baseline serum creatinine \\>200umol/L\n* Currently receiving or at risk of requiring renal replacement therapy\n* Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and fasting blood glucose ≥9.2mmol/L)\n* Malignancy necessitating therapy\n* Life expectancy shorter than the duration of the trial\n* Pregnancy, or childbearing potential and not using a highly effective method of contraception\n* Inability to provide informed consent to participate in the trial","locations":[{"facility":"Hammersmith Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Prapa Kanagaratnam, FRCP PhD","phone":"‭020 3312 6666‬","email":"p.kanagaratnam@imperial.ac.uk"},{"name":"Oliver S Jones, MRCP","phone":"","email":"o.jones@imperial.ac.uk"}],"primaryOutcomes":["Atrial fibrillation cycle length in coronary sinus and left atrial appendage"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Pulmonary vein isolation for Atrial Fibrillation","inPlainEnglish":"Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF). However, it has not been possible to show similar focal drivers during AF, owing to the limitations of mapping in persistent AF.","whoItsFor":["Ages 18 Years to 85 Years","Persistent atrial fibrillation with clinical indication for catheter ablation","Clinically suitable candidate for catheter ablation"],"whoShouldSkip":["Previous atrial fibrillation or other catheter ablation procedure","Clinical contraindication to catheter ablation or general anaesthetic, including history of adverse reaction to contrast media, or presence of intracardiac thrombus, or inadequate anticoagulation in the preceding 6 weeks","Valvular disease graded moderate or greater, or presence of a prosthetic valve","Moderate-to-severe heart failure, defined as left ventricular ejection fraction \\<35% and/or New York Heart Association class III-IV","Any form of cardiomyopathy","Active infection or fever","Severe cerebrovascular disease"],"whatHappens":"If you join, the listed intervention(s) are Pulmonary vein isolation, RETRO-Mapping without adjunctive ablation, or Adjunctive ablation guided by RETRO-Mapping. The registry lists allocation as randomized. Recurrent focal electrical activation (or ectopy) superseding sinus activation is the only mechanism proven to drive paroxysmal atrial fibrillation (AF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 110 people at London. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.736Z"},{"nctId":"NCT06413004","title":"Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)","officialTitle":"Brachyspira and Intestinal Allergy-like Immune Reactions in Patients With Irritable Bowel Syndrome (IBS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Magnus Simrén","sponsorClass":"OTHER","summary":"The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.\n\nDuring this study, the investigators will perform confocal laser endomiscroscopy (CLE) and/or colonoscopic antigen provocation test (COLAP) to test to which food items the participants react to. Furthermore, the investigators will perform rectal barostat examination and a sigmoidoscopy without laxatives. The investigators will collect biological samples and the participants will complete several questionnaires.","conditions":["Irritable Bowel Syndrome","Food Sensitivity"],"keywords":["Irritable Bowel Syndrome","Food Sensitivity","Confocal Laser Endomicroscopy","Colonoscopic Antigen Provocation Test"],"interventions":[{"type":"OTHER","name":"Elimination and re-introduction of CLE or COLAP positive food item(s)"}],"enrollment":200,"startDate":"2022-08-03","completionDate":"2027-12-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with IBS diagnosis according to their treating physician (ROME IV).\n* Association between intake of food and GI symptoms.\n* Witnessed written informed consent prior to any study procedures.\n* Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements.\n\nExclusion Criteria:\n\n* Patients with relevant concurrent organic GI disease (inflammatory bowel disease, abdominal cancer), or a major disease such as diabetes, uncontrolled thyroid disease, heart disease, kidney disease, liver disease, and active malignant disease (not those that were in remission at least 5 years).\n* Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility.\n* Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test).\n* Clinical history of severe allergic reactions.\n* Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year.\n* Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion.\n* Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study.","locations":[{"facility":"Mag-tarmlab, Dept of Internal Medicine, Sahlgrenska University Hospital","city":"Gothenburg","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Magnus Simrén, MD PhD","phone":"0046313428107","email":"magnus.simren@medicine.gu.se"},{"name":"MagTarmlab office","phone":"0046313428107","email":"magtarmlab.su@vgregion.se"}],"primaryOutcomes":["IBS-SSS (Irritable Bowel Syndrom Severity Scoring System) after exclusion (proportion)."],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["gothenburg-sweden"],"enrichment":{"headline":"Not a traditional drug phase: Elimination and re-introduction of CLE or COLAP positive food item(s) for Irritable Bowel Syndrome","inPlainEnglish":"The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging. We hypothesize that Brachyspira infection can cause IBS symptoms by inducing loss of oral tolerance to dietary antigens through development of food-specific intestinal immune reactions and subsequent development of visceral hypersensitivity.","whoItsFor":["Ages 18 Years to 70 Years","Patients with IBS diagnosis according to their treating physician (ROME IV)","Association between intake of food and GI symptoms"],"whoShouldSkip":["Patients with a history of bowel surgery (not appendectomy or cholecystectomy) that affects GI motility","Patients with systemic food allergy as evidenced by positive allergy tests (blood, prick test)","Clinical history of severe allergic reactions","Patients with concurrent major confounding condition(s) based on the clinician's judgement, e.g. DOMINANT psychiatric disorder, vital depression, alcohol or substance abuse in the last 2 year","Female patients who are pregnant or lactating (females of fertile age are requested to use a safe contraceptive) at the time of inclusion","Patients who use or used new medications that affect the GI functioning within 1 month before the start of the study"],"whatHappens":"If you join, the listed intervention(s) are Elimination and re-introduction of CLE or COLAP positive food item(s). The registry lists allocation as na. The aim of this study is to define local immune responses in the GI tract to food antigens in IBS patients, with and without Brachyspira infection, using advanced imaging.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Gothenburg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.444Z"},{"nctId":"NCT06413420","title":"SUNOSI® (Solriamfetol) Pregnancy Registry","officialTitle":"SUNOSI® (Solriamfetol) Pregnancy Registry: An Observational Study on the Safety of Solriamfetol Exposure in Pregnant Women and Their Offspring","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Axsome Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, observational study to evaluate the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).","conditions":["Narcolepsy","Obstructive Sleep Apnea","Pregnant Women and Their Offspring"],"keywords":["Solriamfetol","SUNOSI","Axsome","Narcolepsy","Obstructive Sleep Apnea","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor","Pregnancy outcomes","Infant outcomes"],"interventions":[{"type":"DRUG","name":"Sunosi (solriamfetol)"},{"type":"DRUG","name":"Other prescription wake-promoting medications or stimulants"},{"type":"OTHER","name":"No treatment"}],"enrollment":1731,"startDate":"2019-07-31","completionDate":"2029-09","sex":"FEMALE","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pregnant women of any age\n* Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy or in the relevant exposure window before conception\n* Resident of the US or Canada\n* Provides written informed consent to participate in the study\n* Authorization for her HCP(s) to provide data to the registry\n\nExclusion Criteria:\n\n* Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)","locations":[{"facility":"Evidera, a PPD business unit","city":"Morrisville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PPD, Inc.","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"1-877-283-6220","email":"sunosipregnancyregistry@ppd.com"}],"primaryOutcomes":["Long-term Safety"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["morrisville-north-carolina","wilmington-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: testing Sunosi (solriamfetol) for Narcolepsy","inPlainEnglish":"The SUNOSI (solriamfetol) Pregnancy Registry is a US- and Canada-based prospective, watch-and-measure (no experimental treatment required) study to measure the safety of solriamfetol exposure during pregnancy in women with a diagnosis of narcolepsy or obstructive sleep apnea (OSA).","whoItsFor":["Women only","Pregnant women of any age","Diagnosed with narcolepsy or obstructive sleep apnea OR has taken solriamfetol or other wake promoting medications or stimulants during pregnancy or in the relevant exposure window before conception","Resident of the US or Canada","Authorization for her HCP(s) to provide data to the registry"],"whoShouldSkip":["Occurrence of pregnancy outcome prior to first contact with the registry coordination center (RCC)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,731 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.953Z"},{"nctId":"NCT06418204","title":"Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics","officialTitle":"Complementary Options for Symptom Management In Cancer (COSMIC): Assessing Benefits and Harms of Cannabis and Cannabinoid Use Among a Cohort of Cancer Patients Treated in Community Oncology Clinics","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Wake Forest University Health Sciences","sponsorClass":"OTHER","summary":"This is a multi-site clinical study enrolling 2000 newly diagnosed patients with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer, who are planning to receive one or more systemic cancer directed therapies with chemotherapy and/or (immune checkpoint inhibitors) ICIs.","conditions":["Breast Carcinoma","Colorectal Carcinoma","Lung Non-Small Cell Carcinoma","Melanoma","Non-Hodgkin Lymphoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Non-interventional Study"}],"enrollment":2000,"startDate":"2025-01-30","completionDate":"2028-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older with one of the following newly diagnosed cancers: breast cancer, colorectal cancer, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer (e.g. adenocarcinoma, squamous cell carcinoma, large cell carcinoma, adenosquamous cell carcinoma, and not otherwise specified).\n* Planned treatment with systemic chemotherapy (single or multi-agent, includes targeted therapy) and/or immune checkpoint inhibitor therapy (targeting PD-1, PD-L1 or CTLA-4). If unable to engage participant before treatment starts, enrollment is allowed up to the start of Cycle 2 treatment.\n* Participants must be able to comprehend English or Spanish (for survey completion).\n* Participants must have a working email address and be must be willing to complete surveys online. This can be completed at home, in the clinic or other location.\n* Completion of the confidential Self-Reported Screening Survey and receipt of a screening result - eligible for enrollment.\n* Participant must reside in the United States, officially determined per patient report on Self-reported Screening Survey\n* In the treating provider's opinion, the participant should have a life expectancy of \\>=6 months. Participants in hospice are not eligible.\n\nOptional Sub-study (available at select sites only):\n\n* Must be willing to participate in both the main study and the sub-study at the Wake Forest University Comprehensive Cancer Center (WF CCC) and Virginia Commonwealth University (VCU).\n* Must be receiving treatment at the WF CCC and VCU.\n* Must be planning to receive Immune Checkpoint Inhibitor (ICIs) targeting PD-1, PD-L1 or CTLA-4.\n\nExclusion Criteria:\n\n* Currently enrolled in an interventional supportive treatment trial to manage cancer symptoms.\n* Participants with known pregnancy.\n* Participant received systemic therapy treatment for prior cancer(s) including chemotherapy, immunotherapy, targeted therapy, and hormonal therapy.\n* Participants enrolled in hospice.\n\nOptional Substudy (available at select sites only):\n\n* Participants with chronic or ongoing steroid or immunomodulatory agents (i.e., prednisone, dexamethasone, etanercept, infliximab, etc.). 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Site","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Sarıçam","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Ümraniye","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Yüreğir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Aberdeen","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Port Talbot","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Portsmouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"89bio Clinical Study Site","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: BIO89-100-132 / GC46898 ENLIGHTEN clinical trial / No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Proportion of Participants Achieving Fibrosis Regression","Time to First Occurrence of Disease Progression as Measured by Composite of Protocol -Specified Clinical Events"],"hasResults":false,"conditionSlugs":["fatty-liver"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","homewood-alabama","chandler-arizona","flagstaff-arizona","peoria-arizona","phoenix-arizona","sun-city-arizona","tucson-arizona","little-rock-arkansas","north-little-rock-arkansas","camarillo-california","canoga-park-california","coronado-california","fountain-valley-california","fresno-california","huntington-park-california","la-jolla-california","los-angeles-california","pasadena-california","poway-california","redwood-city-california","rialto-california","sacramento-california","santa-ana-california","littleton-colorado","clermont-florida","fort-myers-florida","gainesville-florida","hialeah-gardens-florida","homestead-florida","jacksonville-florida","lady-lake-florida","lakewood-rch-florida","lehigh-acres-florida","maitland-florida","miami-florida","new-port-richey-florida","ocala-florida","ocoee-florida","orlando-florida","university-park-florida","viera-florida","winter-park-florida","athens-georgia","atlanta-georgia","marietta-georgia","chicago-illinois","glenview-illinois","hammond-indiana","new-albany-indiana","south-bend-indiana","iowa-city-iowa","kansas-city-kansas","topeka-kansas","louisville-kentucky","lafayette-louisiana","lake-charles-louisiana","west-monroe-louisiana","baltimore-maryland","glen-burnie-maryland","greenbelt-maryland","burlington-massachusetts","framingham-massachusetts","ann-arbor-michigan","clinton-township-michigan","detroit-michigan","wyoming-michigan","ypsilanti-michigan","minneapolis-minnesota","rochester-minnesota","flowood-mississippi","tupelo-mississippi","st-louis-missouri","las-vegas-nevada","florham-park-new-jersey","somers-point-new-jersey","albuquerque-new-mexico","albany-new-york","new-york-new-york","asheville-north-carolina","charlotte-north-carolina","durham-north-carolina","fayetteville-north-carolina","greenville-north-carolina","winston-salem-north-carolina","akron-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","dayton-ohio","liberty-township-ohio","westlake-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","east-greenwich-rhode-island","charleston-south-carolina","columbia-south-carolina","rapid-city-south-dakota","cordova-tennessee","hermitage-tennessee","nashville-tennessee","amarillo-texas","austin-texas","brownsville-texas","desoto-texas","edinburg-texas","farmers-branch-texas","fort-worth-texas","georgetown-texas","harlingen-texas","houston-texas","lewisville-texas","lubbock-texas","mansfield-texas","pearland-texas","san-antonio-texas","san-marcos-texas","southlake-texas","tyler-texas","waco-texas","sandy-city-utah","west-jordan-utah","richmond-virginia","bellevue-washington","seattle-washington","tacoma-washington","buenos-aires-argentina","caba-argentina","capital-federal-argentina","c-rdoba-argentina","pilar-argentina","adelaide-australia","fitzroy-australia","greenslopes-australia","heidelberg-australia","herston-australia","murdoch-australia","perth-australia","south-brisbane-australia","brussels-belgium","edegem-belgium","genk-belgium","ghent-belgium","roeselare-belgium","barretos-brazil","belo-horizonte-brazil","botucatu-brazil","bras-lia-brazil","goi-nia-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","salvador-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","vit-ria-brazil","gorna-oryahovitsa-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","calgary-canada","vancouver-canada","winnipeg-canada","london-canada","ottawa-canada","toronto-canada","vaughan-canada","amiens-france","clichy-france","dijon-france","limoges-france","lyon-france","montpellier-france","nice-france","paris-france","pessac-france","strasbourg-france","toulouse-france","vand-uvre-l-s-nancy-france","v-nissieux-france","villejuif-france","tbilisi-georgia","chemnitz-germany","frankfurt-germany","freiburg-im-breisgau-germany","hanover-germany","homburg-germany","m-nster-germany","hong-kong-hong-kong","shatin-hong-kong","budapest-hungary","gujr-t-india","prayagraj-india","rajpur-sonarpur-india","s-rat-india","wardha-india","afula-israel","beersheba-israel","haifa-israel","jerusalem-israel","nahariya-israel","petah-tikva-israel","tel-aviv-israel","tel-hashomer-israel","bergamo-italy","foggia-italy","milan-italy","novara-italy","palermo-italy","roma-italy","rome-italy","rozzano-italy","torino-italy","chihuahua-city-mexico","cuautitl-n-izcalli-mexico","cuernavaca-mexico","jalisco-mexico","mexico-city-mexico","m-rida-mexico","monterrey-mexico","amsterdam-netherlands","rotterdam-netherlands","tilburg-netherlands","utrecht-netherlands","katowice-poland","krakow-poland","lodz-poland","mys-owice-poland","warsaw-poland","wroclaw-poland","manati-puerto-rico","mayag-ez-puerto-rico","san-juan-puerto-rico","singapore-singapore","bucheon-si-south-korea","busan-south-korea","daegu-south-korea","incheon-south-korea","seoul-south-korea","almer-a-spain","badalona-spain","barcelona-spain","c-rdoba-spain","madrid-spain","m-laga-spain","pontevedra-spain","santander-spain","santiago-de-compostela-spain","zaragoza-spain","chiayi-city-taiwan","kaohsiung-city-taiwan","tainan-taiwan","bornova-turkey-t-rkiye","merkez-turkey-t-rkiye","ankara-turkey-t-rkiye","fatih-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","sar-am-turkey-t-rkiye","mraniye-turkey-t-rkiye","y-re-ir-turkey-t-rkiye","aberdeen-united-kingdom","bristol-united-kingdom","leeds-united-kingdom","london-united-kingdom","oxford-united-kingdom","plymouth-united-kingdom","port-talbot-united-kingdom","portsmouth-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Pegozafermin for Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis","inPlainEnglish":"The study will assess the how well it works and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .","whoItsFor":["Ages 18 Years to 75 Years","Participants must have type 2 diabetes mellitus diagnosed at least 3 months before screening or at least 2 metabolic risk factors","Evidence of both cirrhosis and MASH etiology, either through a historical biopsy or a biopsy at Screening","Clinical diagnosis of cirrhosis based on the NIT algorithm"],"whoShouldSkip":["Liver disorder other than MASH","History or evidence of hepatic decompensation","History or evidence of hepatocellular carcinoma","Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus","ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L)","Participants taking vitamin E (\\>400 international units \\[IU\\]/day) must be on stable dose for at least 6 months prior to screening","Other protocol-defined inclusion and"],"whatHappens":"If you join, the listed intervention(s) are Pegozafermin, or Placebo. The registry lists allocation as randomized. The study will assess the how well it works and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,800 people at 268 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.157Z"},{"nctId":"NCT06421649","title":"Investigating the Role of Adjuvant Proton Beam Therapy in Patients With Parotid Carcinoma","officialTitle":"An Evaluative Commissioning Study to Investigate the Role of Adjuvant Proton Beam Radiotherapy in Patients With Localised Parotid Carcinoma","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Christie NHS Foundation Trust","sponsorClass":"OTHER","summary":"Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London. The NHS is committed to ensuring the best use of this limited resource by investigating which patients will benefit from PBT treatment.\n\nEvaluative Commissioning in Protons (ECIP) is a programme of studies that explore the role of PBT for patients with different types of cancer. They are funded by NHS England. ECIP studies are not randomised studies, which means that all eligible patients will be offered proton therapy. Any patient in the United Kingdom (UK) can be referred, and for patients that need to travel far to their nearest centre, accommodation will be available.\n\nThe main benefit of PBT, compared with photon radiotherapy, is the predicted reduction in radiation dose to surrounding healthy tissues. With photon radiotherapy, some radiation passes beyond the target area, affecting healthy tissues and causing side-effects. With PBT, the radiation dose stops within the target area, causing less damage to surrounding tissues, and limiting side effects.\n\nPRONTO is a study within the ECIP programme exploring whether PBT can reduce treatment side effects for patients with salivary gland cancers who need radiotherapy following surgery. Whilst radiotherapy is associated with good cancer control, it commonly causes problematic side-effects such as loss of taste and dry mouth. These can be permanent and can negatively affect someone's quality of life. PRONTO's main aim is to see if PBT can reduce the loss of taste following radiotherapy.\n\nParticipants in PRONTO will be closely monitored by the medical team and with questionnaires. The patient experience will be compared to what we would expect with standard photon radiotherapy.","conditions":["Parotid Cancer"],"keywords":["proton beam therapy","protons","evaluative commissioning"],"interventions":[{"type":"RADIATION","name":"Proton Beam Therapy"}],"enrollment":97,"startDate":"2025-09-05","completionDate":"2029-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ≥ 18 years old.\n2. Histologically confirmed primary malignant tumours of parotid gland.\n3. Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction.\n4. Treatment delivered with radical intent.\n5. All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up.\n6. Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment.\n7. Written informed consent.\n\nExclusion Criteria:\n\n1. Previous radiotherapy to the head and neck region;\n2. Parotid tumours requiring primary radiation or those with gross residual disease;\n3. Metastases from squamous cell carcinoma of the head and neck to the parotid gland;\n4. Benign tumours requiring post operative radiotherapy;\n5. Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;\n6. Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy.\n7. Patients who are eligible for PBT under routine commissioning","locations":[{"facility":"University College London Hospitals NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Romelie Rieu","phone":"0044 1619187172","email":"romelie.rieu@nhs.net"},{"name":"Sally Falk","phone":"0044 1619187172","email":"sally.falk@nhs.net"}],"primaryOutcomes":["Taste dysfunction"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Proton Beam Therapy for Parotid Cancer","inPlainEnglish":"Proton Beam Therapy (PBT) is an advanced radiotherapy technique. There are two National Health Service (NHS) PBT treatment centres in the UK, one in Manchester and one in London.","whoItsFor":["Ages 18 Years to any","Histologically confirmed primary malignant tumours of parotid gland","Requiring post-operative radiotherapy to the parotid bed, with a dose equivalent of at least 60 Gray (Gy) in 2 Gy / fraction","Treatment delivered with radical intent","All patients must be suitable to attend regular follow-up, audiograms, toxicity monitoring, and be available for long term follow-up","Willingness to comply with the protocol, including travel to the proton centre for Intensity Modulated Proton Therapy (IMPT) treatment"],"whoShouldSkip":["Previous radiotherapy to the head and neck region;","Parotid tumours requiring primary radiation or those with gross residual disease;","Metastases from squamous cell carcinoma of the head and neck to the parotid gland;","Benign tumours requiring post operative radiotherapy;","Previous or concurrent illness, which in the investigators opinion would interfere with either completion of therapy or follow-up;","Patients requiring or receiving neoadjuvant, concomitant or planned adjuvant chemotherapy","Patients who are eligible for PBT under routine commissioning"],"whatHappens":"If you join, the listed intervention(s) are Proton Beam Therapy. The registry lists allocation as na. Proton Beam Therapy (PBT) is an advanced radiotherapy technique.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 97 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.324Z"},{"nctId":"NCT06422546","title":"A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC","officialTitle":"A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers After Three Weeks of Osimertinib Targeted Therapy in Chinese Patients With Stage IIIB ,IIIC ,or IV Metastatic or Recurrent Non Squamous EGFR-positive Non-small Cell Lung Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Beijing Cancer Prevention & Treatment Society","sponsorClass":"OTHER","summary":"A prospective ,multicenter ,non-interventional ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in EGFRm NSCLC","conditions":["Non Small Cell Lung Cancer"],"keywords":[],"interventions":[],"enrollment":950,"startDate":"2022-01-13","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female,age ≥18 years.\n2. Newly diagnosed,histologically confirmed,and classified as stage IIIB,IIIC,IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy .\n3. No prior systemic antitumor therapy, including EGFR -TKIs or immunotherapy .\n4. Presence of an EGFR mutation confirmed by a local laboratory in blood or tissue samples .\n5. Adequate blood samples available for molecular testing .\n6. Provision of written informed consent .\n\nExclusion Criteria:\n\n1. Inability to provide plasma samples at baseline .\n2. Baseline blood EGFR mutation status not confirmed by the central laboratory .\n3. Refusal to receive subsequent treatment with osimertinib .\n4. Any condition that ,in the investigator's judgment ,could interfere with study procedures or confound outcome assessment .","locations":[{"facility":"Cancer Hospital Chinese","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["To describe the characteristics of EGFR mutation changes at baseline and after 3 weeks of osimertinib treatment"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osi…","inPlainEnglish":"A prospective ,multicenter ,non-treatment ,real-world study observing changes in molecular markers after three weeks of osimertinib targeted therapy in EGFRm NSCLC","whoItsFor":["Ages 18 Years to any","Male or female,age ≥18 years","Newly diagnosed,histologically confirmed,and classified as stage IIIB,IIIC,IV or recurrent NSCLC which are not amenable to curative surgery or radiotherapy","No prior systemic antitumor therapy, including EGFR -TKIs or immunotherapy","Presence of an EGFR mutation confirmed by a local laboratory in blood or tissue samples","Adequate blood samples available for molecular testing"],"whoShouldSkip":["Inability to provide plasma samples at baseline","Baseline blood EGFR mutation status not confirmed by the central laboratory","Refusal to receive subsequent treatment with osimertinib","Any condition that ,in the investigator's judgment ,could interfere with study procedures or confound outcome assessment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 950 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.671Z"},{"nctId":"NCT06424288","title":"A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","officialTitle":"EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day.\n* Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.","conditions":["Heart Failure"],"keywords":[],"interventions":[{"type":"DRUG","name":"vicadrostat"},{"type":"DRUG","name":"empagliflozin"},{"type":"DRUG","name":"placebo"}],"enrollment":6712,"startDate":"2024-06-17","completionDate":"2028-05-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg/m² to \\<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery/CABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.","locations":[{"facility":"Diagnostic and Medical Clinic","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mobile Heart Specialists, PC","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Chula Vista","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North America Research Institute","city":"San 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3: testing vicadrostat for Heart Failure","inPlainEnglish":"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more.","whoItsFor":["Ages 18 Years to any","At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years","Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:","in participants with body mass index (body-mass index (BMI)) \\<27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)","in participants with body-mass index (BMI) ≥27 kg/m² to \\<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)","in participants with body-mass index (BMI) ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)","At least one of the following:","Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1"],"whoShouldSkip":["Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator","Receiving the following treatments:","a direct renin inhibitor (e.g. aliskiren) at Visit 2","more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2","In case of acute decompensated HF:","i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)","Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2"],"whatHappens":"If you join, the listed intervention(s) are vicadrostat, empagliflozin, or placebo. The registry lists allocation as randomized. This study is open to adults aged 18 or above legal age with heart failure.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 6,712 people at 668 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.611Z"},{"nctId":"NCT06427343","title":"The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency","officialTitle":"The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"China-Japan Friendship Hospital","sponsorClass":"OTHER","summary":"This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.","conditions":["Heart Failure","Iron Deficiency"],"keywords":["IRONDOSE"],"interventions":[{"type":"DRUG","name":"High-dose ferric derisomaltose"},{"type":"DRUG","name":"Low-dose ferric derisomaltose"}],"enrollment":114,"startDate":"2023-10-01","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age \\>18 years.\n2. Left ventricular ejection fraction (LVEF) \\<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).\n3. New York Heart Association (NYHA) class II \\~ III.\n4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \\>300 pg/mL or BNP \\>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP \\>600 pg/mL or BNP \\>200 pg/mL.\n5. Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).\n6. Serum ferritin \\<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \\<20%.\n7. Able and willing to perform a CPET at the time of randomization.\n8. Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Hemoglobin \\<9.0 g/dL or Hemoglobin \\>15.0 g/dL.\n2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15 ml/min/1.73m2.\n3. Body weight \\<35 kg.\n4. Heart failure was secondary to valvular diseases or congenital heart diseases.\n5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.\n6. Known hypersensitivity to ferric derisomaltose or other IV iron product.\n7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.\n8. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \\>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV/AIDS disease.\n9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.\n10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.\n11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.\n12. Use of concurrent immunosuppressive therapy\n13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \\>100 beats/min at rest), or uncontrolled hypertension with blood pressure \\>160/100 mm Hg.\n14. Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.\n15. Pregnancy or breast feeding.\n16. Participation in another intervention study involving a drug or device within the past 90 days.","locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jingyi Ren","phone":"18600195099","email":"renjingyi1213@hotmail.com"},{"name":"Lina Su","phone":"18801230212","email":"sln920722@163.com"}],"primaryOutcomes":["Change in peak VO2 (ml/min/kg）"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 4: testing High-dose ferric derisomaltose for Heart Failure","inPlainEnglish":"This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.","whoItsFor":["Ages 18 Years to any","Left ventricular ejection fraction (LVEF) \\<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI)","New York Heart Association (NYHA) class II \\~ III","Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics)","Serum ferritin \\<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \\<20%","Able and willing to perform a CPET at the time of randomization"],"whoShouldSkip":["Hemoglobin \\<9.0 g/dL or Hemoglobin \\>15.0 g/dL","Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \\<15 ml/min/1.73m2","Body weight \\<35 kg","Heart failure was secondary to valvular diseases or congenital heart diseases","History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis","Known hypersensitivity to ferric derisomaltose or other IV iron product","Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia"],"whatHappens":"If you join, the listed intervention(s) are High-dose ferric derisomaltose, or Low-dose ferric derisomaltose. The registry lists allocation as randomized. This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 114 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.444Z"},{"nctId":"NCT06429176","title":"Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84 in Patients With Cystic Fibrosis","officialTitle":"A Phase 2a, Randomized, Placebo-Controlled, Double Blind Multiple Ascending Dose Study in Patients With Cystic Fibrosis Carrying the 3849 +10 Kb C->T Mutation to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SPL84","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"SpliSense Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation (3849 +10kb C--\\>T).\n\nThe purpose of this research study is to test the safety and effectiveness of multiple doses of the study drug, SPL84.\n\nResearchers will compare drug SPL84 to a placebo (a look-alike substance that contains no drug) to see if drug SPL84 is safe and if it works to treat CF. In cohorts 1-3, SPL84 will be tested as a monotherapy, and in Cohort 4, SPL84 will be tested in participants who are already stable on CFTR modulator therapy.\n\nParticipants will take drug SPL84 or a placebo by inhalation every week for 9 weeks (cohorts 1-3) or 12 weeks (cohort 4) and visit the clinic approximately weekly for checkups and tests.","conditions":["Cystic Fibrosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"SPL84"},{"type":"OTHER","name":"Placebo"}],"enrollment":64,"startDate":"2024-06-24","completionDate":"2027-10-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Cohort 1-3:\n\nInclusion Criteria:\n\n* Diagnosis of CF and two CF causing mutations; 3849+10 Kb C-\\>T mutation on one allele in the CF transmembrane conductance regulator (CFTR) gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required.\n* Body mass index (BMI) of ≥ 17 kg/m2.\n* FEV1 40-90% predicted at screening.\n* Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report.\n\nExclusion Criteria:\n\n* Use of Kalydeco, Orkambi, Symdeko/Symkevi or Trikafta/Kaftrio within 30 days of first dose with study intervention.\n* Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention.\n* Use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. Use of inhaled steroids above 1 mg.\n* Use of CF medications, e.g. inhaled antibiotics, dornase alfa (Pulmozyme), hypertonic saline and physiotherapy should be on stable regimen for the period 28 days prior to screening; those participants taking inhaled antibiotics for prophylaxis must be on a stable regimen of these drugs for at least 90 days prior to first dose with study intervention.\n* Any acute infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation, changes in therapy for pulmonary disease, or any non CF-related illness which results in the initiation of any new therapy within 14 days prior to first dose with study intervention.\n* Hemoptysis of greater than 30 mL within 90 days prior to Day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention.\n* Liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension.\n* History of any organ transplantation.\n* Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing.\n\nCohort 4:\n\nInclusion Criteria:\n\n* Diagnosis of CF and two CF causing mutations; 3849+10 Kb C-\\>T mutation on one allele in the CF transmembrane conductance regulator (CFTR) gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required.\n* Body mass index (BMI) of ≥ 17 kg/m2.\n* FEV1 40-80% predicted at screening.\n* Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report.\n* Stable adherence to standard use of Trikafta/Kaftio or Alyftrek for at least 3 months, or Alyftrek for 1 month after switching from Trikafta/Kaftio, according to prescribing information.\n\nExclusion Criteria:\n\n* Previous participation in active arm of SPL84-002 study (Cohort 1-3)\n* Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention.\n* Use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. Use of inhaled steroids above 1 mg.\n* Use of CF medications, e.g. inhaled antibiotics, dornase alfa (Pulmozyme), hypertonic saline and physiotherapy should be on stable regimen for the period 28 days prior to screening; those participants taking inhaled antibiotics for prophylaxis must be on a stable regimen of these drugs for at least 90 days prior to first dose with study intervention.\n* Any acute infection including acute upper respiratory or lower respiratory infections, pulmonary exacerbation, changes in therapy for pulmonary disease, or any non CF-related illness which results in the initiation of any new therapy within 14 days prior to first dose with study intervention.\n* Hemoptysis of greater than 30 mL within 90 days prior to Day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention.\n* Liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension.\n* History of any organ transplantation.\n* Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing.","locations":[{"facility":"Memorial Care Long Beach Medical Center","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Santa Monica","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Jewish Health","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Joe DiMaggio Children's Hospital","city":"Hollywood","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boston Children'S Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lenox Hill Cystic Fibrosis Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Cystic Fibrosis Program","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inova Fairfax Hospital","city":"Falls Church","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Washington Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Motol University Hospital","city":"Prague","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Régional Universitaire (CHRU) de Montpellier","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité - Universitätsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Westbrandenburg CF Zentrum Potsdam","city":"Potsdam","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Mt. Scopus Hospital","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center (Beilinson Hospital)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of Lithuanian University of Health Sciences Kaunas Clinics","city":"Kaunas","state":"","country":"Lithuania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kliniki Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytetu Medycznego im.Karola Marcinkowskiego w Poznaniu","city":"Poznan","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instytut Gruźlicy i Chorób Płuc Oddział Terenowy im. Jana i Ireny Rudników","city":"Rabka-Zdrój","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vall d'Hebron Barcelona Hospital Campus","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Safety and Tolerability of SPL84 as evaluated by number of subjects with at least one treatment-related adverse event (AE) or serious adverse event (SAEs)","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal heart rate","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal respiratory rate","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal systolic and diastolic blood pressure","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal oximetry","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal temperature","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal hematology lab test results","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal biochemistry lab test results","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal urinalysis lab test results","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal electrocardiogram (ECG) parameters","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal physical examination findings","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal pulmonary function tests results","Safety and Tolerability of SPL84 as assessed by number of participants with abnormal immunogenicity results"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["long-beach-california","los-angeles-california","san-francisco-california","santa-monica-california","denver-colorado","hollywood-florida","chicago-illinois","boston-massachusetts","minneapolis-minnesota","new-york-new-york","chapel-hill-north-carolina","philadelphia-pennsylvania","salt-lake-city-utah","falls-church-virginia","seattle-washington","prague-czechia","montpellier-france","berlin-germany","potsdam-germany","jerusalem-israel","petah-tikva-israel","milan-italy","kaunas-lithuania","poznan-poland","rabka-zdr-j-poland","barcelona-spain"],"enrichment":{"headline":"Phase 2: testing SPL84 for Cystic Fibrosis","inPlainEnglish":"The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF). It will also learn if the drug works to treat works to treat CF with a specific mutation (3849 +10kb C--\\>T).","whoItsFor":["Ages 18 Years to any","Diagnosis of CF and two CF causing mutations; 3849+10 Kb C-\\>T mutation on one allele in the CF transmembrane conductance regulator (CFTR) gene (homozygote or compound heterozygote). Source documentation from a certified genetic laboratory is required","Body mass index (body-mass index (BMI)) of ≥ 17 kg/m2","FEV1 40-90% predicted at screening","Non-smokers or vapers for at least 180 days (6 months) prior to screening, per participant report"],"whoShouldSkip":["Use of Kalydeco, Orkambi, Symdeko/Symkevi or Trikafta/Kaftrio within 30 days of first dose with study intervention","Use of any investigational drug (other than SPL84) or device within 30 days of first dose with study intervention","Use of systemic steroids over 3 consecutive months in the last 6 months prior to screening, or use of systemic steroids in the last month prior to screening. Use of inhaled steroids above 1 mg","Hemoptysis of greater than 30 mL within 90 days prior to Day 1, or hospitalization for hemoptysis within 6 months of first dose with study intervention","Liver disease characterized by clinically significant cirrhosis and/or documented portal hypertension","History of any organ transplantation","Documented coronavirus disease (COVID-19) infection within 4 weeks prior to dosing"],"whatHappens":"If you join, the listed intervention(s) are SPL84, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if drug SPL84 is safe for adult patients with cystic fibrosis (CF).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 64 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.416Z"},{"nctId":"NCT06430684","title":"Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease","officialTitle":"Feasibility Trial of Sodium-GLucose coTransporter 2 INhibitors in Pediatric Chronic KIDney DiSease","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ann & Robert H Lurie Children's Hospital of Chicago","sponsorClass":"OTHER","summary":"The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease. The main questions are:\n\n1. Is enrolling 40 youth with CKD into a clinical trial of empagliflozin feasible (ie achievable)?\n2. Does taking empagliflozin for 3 months result in positive changes in blood, urine, and heart function tests?\n\nParticipants will be randomly selected (like flipping a coin) to either receive empagliflozin or not start treatment with empagliflozin and remain on their usual care.\n\nStudy Procedures Include\n\n* For participants randomly selected for treatment, take empagliflozin once daily for 3 months\n* Phone calls with researchers every 2 weeks for check-ins\n* For participants taking empagliflozin, clinic visits 4 and 8 weeks after starting for check-ups and tests\n* All study participants will have clinic visits at the beginning and end (3 months) where researchers will collect information about their health and perform tests","conditions":["Chronic Kidney Diseases","Pediatric Kidney Disease"],"keywords":["Sodium Glucose Co-Transporter 2 Inhibitor","SGLT2i","Pediatric CKD","Feasibility Study","Clinical Trial"],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"}],"enrollment":40,"startDate":"2024-08-23","completionDate":"2026-09-01","sex":"ALL","minAge":"12 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2\n\nExclusion Criteria:\n\n* Heart Disease\n* Diabetes\n* Pregnancy\n* Recipient of solid organ transplant\n* history of chemotherapy or stem cell transplant\n* moderate to severe persistent asthma\n* liver disease\n* class 2 or greater obesity\n* inability to follow study procedures due to cognitive impairment\n* obstructive uropathy or requirement for intermittent urinary catheterization\n* systolic blood pressure \\<100mgHg\n* orthostatic hypotension\n* current use of an SGLT2i\n* anticipated need for titration of anti-hypertensives within 3 months\n* active use of any immunosuppressive medications\n* lack of clearance by primary nephrologist for participation","locations":[{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alexander J Kula, MD, MHS","phone":"312-227-6160","email":"alexkula@luriechildrens.org"}],"primaryOutcomes":["Percentage of participants who complete all study procedures"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":["empagliflozin"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Early phase 1: testing Empagliflozin 10 MG for Chronic Kidney Diseases","inPlainEnglish":"The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD). The investigators also plan to explore whether treatment with SGLT2i (Empagliflozin) helps improve risk factors for worsening kidney and heart disease.","whoItsFor":["Ages 12 Years to 25 Years","Stage 3-4 CKD; estimated GFR using CKiD U25-creatinine equation 20-60mL/min/1.73m2"],"whoShouldSkip":["Recipient of solid organ transplant","history of chemotherapy or stem cell transplant","moderate to severe persistent asthma","class 2 or greater obesity","inability to follow study procedures due to cognitive impairment","obstructive uropathy or requirement for intermittent urinary catheterization","systolic blood pressure \\<100mgHg"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG. The registry lists allocation as randomized. The goal of this study is to learn if a clinical trial of sodium-glucose co-transporter 2 inhibitors (SGLT2i) is possible in youth with chronic kidney disease (CKD).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 40 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.621Z"},{"nctId":"NCT06430801","title":"A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\<150, US/FDA) or stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).","conditions":["Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"IV Tulisokibart"},{"type":"DRUG","name":"SC Tulisokibart"},{"type":"OTHER","name":"IV Placebo"},{"type":"OTHER","name":"SC Placebo"}],"enrollment":1200,"startDate":"2024-06-05","completionDate":"2028-10-30","sex":"ALL","minAge":"16 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of Crohn's disease (CD) at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies.\n* Adolescent participants ≥16 and \\<18 years of age can participate if approved by the country or regulatory/health authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides CD.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\<5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-tumor necrosis factor-like cytokine 1A (TL1A) antibody (Ab).","locations":[{"facility":"Digestive Health Specialists ( Site 5064)","city":"Dothan","state":"Alabama","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Arizona Arthritis & Rheumatology Research, PC ( Site 5094)","city":"Phoenix","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"GI Alliance - Sun City ( Site 5118)","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences ( Site 5147)","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinnova Research ( Site 5110)","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Research Center ( Site 5044)","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research LLC ( Site 5038)","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai Medical Center ( Site 5080)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine (UCI) Health - 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GURNEE ( Site 5003)","city":"Gurnee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health University Hospital ( Site 5022)","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iowa Digestive Disease Center ( Site 5007)","city":"Clive","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center ( Site 5091)","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Digestive Health Center ( Site 5033)","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville Hospital ( Site 5120)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Clinical Research ( Site 5095)","city":"Zachary","state":"Louisiana","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Walter Reed National Military Medical Center ( Site 5006)","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital-Crohn's and Colitis Center ( Site 5037)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan ( Site 5060)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute of Michigan, LLC ( Site 5002)","city":"Clinton Township","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester, Minnesota ( Site 5024)","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-America GI Clinical Research ( Site 5130)","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BVL Research - Kansas ( Site 5099)","city":"Liberty","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine ( Site 5058)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HMH Justice Marie Garibaldi Medical Plaza ( Site 5072)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health Physician Partners Center for Advanced IBD Care ( Site 5017)","city":"Great Neck","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Circuit Clinical /Crystal Run Healthcare LLP ( Site 5050)","city":"Middletown","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health - Inflammatory Bowel Disease Center (IBD) ( Site 5078)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medical College, New-York Presbyterian Hospital ( Site 5079)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Gastroenterology Associates ( Site 5013)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Mather Hospital ( Site 5138)","city":"Port Jefferson","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina Medical Center ( Site 5034)","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Gastroenterology MMP ( Site 5105)","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Javara - 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DeBakey VA Medical Center ( Site 5086)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Lubbock ( Site 5012)","city":"Lubbock","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Caprock Gastro Research ( Site 5077)","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance: Mansfield ( Site 5015)","city":"Mansfield","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Southern Star Research Institute ( Site 5000)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Southlake ( Site 5109)","city":"Southlake","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tyler Research Institute ( Site 5001)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond VA Medical Center ( Site 5021)","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Gastroenterology - 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( Site 0006)","city":"Vaughan","state":"Ontario","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre de recherche du CISSS de Chaudière-Appalaches - Hôpital Hôtel Dieu de Levis ( Site 0011)","city":"Lévis","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal - Gastroenterology ( Site 0013)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal General Hospital ( Site 0003)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diex Recherche Quebec ( Site 0008)","city":"Québec","state":"Quebec","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hospital hernan henriquez aravena de temuco ( Site 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3: testing IV Tulisokibart for Crohn's Disease","inPlainEnglish":"The purpose of this protocol is to measure the how well it works and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to dummy treatment (placebo) in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 52 (US/FDA and EU/EMA), and that at least 1 tulisokibart dose level is superior to dummy treatment (placebo) in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\<150, US/FDA) or per stool frequency and abdominal pain score (EU/EMA) and in the proportion of participants achieving endoscopic response at Week 12 (US/FDA and EU/EMA).","whoItsFor":["Ages 16 Years to 80 Years","The main inclusion and"],"whoShouldSkip":["include but are not limited to the following:","who can join:","Has had a diagnosis of Crohn's disease (CD) at least 3 months before study","Has moderately to severely active CD","Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and/or small molecule advanced therapies","Adolescent participants ≥16 and \\<18 years of age can participate if approved by the country or regulatory/health authority"],"whatHappens":"If you join, the listed intervention(s) are IV Tulisokibart, SC Tulisokibart, or IV Placebo. The registry lists allocation as randomized. The purpose of this protocol is to measure the how well it works and safety of tulisokibart in participants with moderately to severely active Crohn's disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,200 people at 499 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.886Z"},{"nctId":"NCT06433921","title":"A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive","officialTitle":"A Phase 1, Randomized, 2-part, 7-way Cross-over (Part 1) and 7-way Cross-over (Part 2), Blinded, Single Dose Study in Mild Asthmatics Aged 18-65 to Assess the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers Containing Propellants HFA-152a (Test) and HFA-134a (Reference) Via Methacholine Bronchoprovocation and Systemic Pharmacodynamic Effects","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.","conditions":["Asthma","Mild Asthma"],"keywords":["Salbutamol","Propellant HFA-152a","Propellant HFA-134a","Metered dose inhalers","Mild asthma"],"interventions":[{"type":"DRUG","name":"Salbutamol HFA-152a"},{"type":"DRUG","name":"Salbutamol HFA-134a"},{"type":"DRUG","name":"Placebo"}],"enrollment":84,"startDate":"2024-08-14","completionDate":"2027-04-16","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.\n2. Participant must be 18 to 65 years of age inclusive, at the time of screening.\n3. ≥50 kg, at the time of screening.\n4. Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening.\n\n4\\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study: i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.\n\niii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA \\[GINA, 2023\\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.\n\n6\\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.\n\n7\\. Pre-bronchodilator FEV1 ≥80% of predicted, at screening. 8. PC20 to methacholine of ≤8 mg/mL, at screening. 9. Participants should be able to withhold SABA for ≥12 hours and LABA-containing medications for ≥48 hours for the purposes of performing the spirometry and methacholine challenge at screening and during the study visits (treatment periods).\n\n10\\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.\n\n11\\. Provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n\n12\\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.\n\nExclusion Criteria:\n\n1. Medical Conditions\n\n   1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.\n   2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.\n   3. Asymptomatic gallstones.\n   4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.\n   5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.\n   6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.\n2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.\n3. Participants who are currently or in the last 15 days have worked nightshifts.\n4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \\>21 units for males or \\>14 units for females.\n5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.\n6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to \"vape\" within 12 months prior to the start of the study.","locations":[{"facility":"GSK Investigational Site","city":"Manchester","state":"Greater Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Part 1 & Part 2: Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["manchester-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Salbutamol HFA-152a for Asthma","inPlainEnglish":"The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on how well it works (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on how well it works (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.","whoItsFor":["Ages 18 Years to 65 Years","Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal","Participant must be 18 to 65 years of age inclusive, at the time of screening","≥50 kg, at the time of screening","Body mass index (body-mass index (BMI)) with 19.0-35.0 kg/m2 inclusive, at the time of screening","6\\. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening","10\\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective","12\\. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years"],"whoShouldSkip":["A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator","Asymptomatic gallstones","History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study","Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful","Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis","Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer","Participants who are currently or in the last 15 days have worked nightshifts"],"whatHappens":"If you join, the listed intervention(s) are Salbutamol HFA-152a, Salbutamol HFA-134a, or Placebo. The registry lists allocation as randomized. The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on how well it works (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) \\[PC20\\]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 84 people at Manchester. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.344Z"},{"nctId":"NCT06434363","title":"Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders","officialTitle":"Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.\n\nThe goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.\n\nThe goal of Phase 2 is to learn if the dose of AD-PluReceptor-NK cells found in Phase 1 in combination with tafasitamab and lymphodepleting chemotherapy can help to control the disease.","conditions":["Autoimmune Disorders","Systemic Sclerosis","Systemic Lupus Erythematosus","Lupus","Lupus Nephritis"],"keywords":["CAR NK, CAR, Natural Killer, SSc, SLE, LN, GVHD, Chronic GVHD"],"interventions":[{"type":"DRUG","name":"Tafasitamab"},{"type":"DRUG","name":"Fludarabine phosphate"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Tafasitamab and NK cells"}],"enrollment":47,"startDate":"2024-07-31","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nSSc Specific Inclusion Criteria\n\nA. Diagnosis of SSc defined as follows:\n\ni) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening.\n\nB. SSc disease activity i) Diffuse SSc meeting the following criteria:\n\n(1) Disease duration ≤ 7 years (from onset of first non-Raynaud manifestation) AND (2) mRSS ≥ 15 at screening (Appendix 1) OR ii) Participants diagnosed with diffuse or limited cutaneous SSc AND presence of ILD changes on HRCT AND Disease duration ≤ 7 years (from onset of first non- Raynaud manifestation) AND either (1) or (2)\n\n1. Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):\n\n   (a) worsening respiratory symptoms (b) physiological evidence of disease progression (≥ 1 of the following): (i) Absolute decline in FVC ≥ 5% predicted within 1 year of follow-up (ii) Absolute decline in DLCO (corrected for Hb) ≥ 10% predicted within 1 year of follow-up radiological evidence of disease progression (c) radiological evidence of disease progression (≥ 1 of the following):\n\n   (i) Increased extent or severity of traction bronchiectasis and bronchiolectasis.\n\n   (ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality.\n\n   (v) New or increased honeycombing (vi) Increased lobar volume loss\n2. FVC \\< 80% predicted or extent of ILD changes on HRCT \\> 20%. C. Inadequate response to at least 1 of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab\n\nSLE Specific Inclusion Criteria\n\n1. A clinical diagnosis of SLE, based on the 2019 EULAR/ ACR classification criteria for adult SLE.\n2. Positive ANA titer ≥1:80 or positive anti-dsDNA antibody at screening or prior to screening.\n3. For LN subjects only: Active, biopsy-proven lupus nephritis (kidney biopsy should have been done within 1 year of study enrollment) class III or IV, with or without the presence of Class V, using the 2018 Revised International Society of Nephrology/Renal Pathology Society criteria48.\n4. Diagnosed with active SLE. Subjects with either LN or without LN will be eligible if they meet the following criteria:\n\n   a. For LN subjects: urine protein-to-creatinine ratio (UPCR) ≥0.5 g/g on 2 first morning void urine samples during screening despite prior or current treatment with standard of care therapy for at least 12 weeks, including corticosteroids, MMF/mycophenolic acid (MPA), CY, calcineurin inhibitors, belimumab, and/or rituximab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, b. For non-renal SLE subjects: SLEDAI-2K ≥8 and clinical SLEDAI-2K ≥6 (excluding headache, alopecia, mucosal ulcers, fever, and organic brain syndrome) or ≥ 1 major organ system with a BILAG A score (excluding musculoskeletal, mucocutaneous, and/or constitutional organ system) during screening despite prior or current treatment with standard of care therapy, including corticosteroids, rituximab or other B cell depleting agents, CY, MMF/MPA, azathioprine, methotrexate, 6-mercaptopurine, sirolimus, tacrolimus, thalidomide, leflunomide, mizorbine, anifrolumab, and/or belimumab. Patients should have failed at least 2 standard of care immunosuppressive therapies tried for 3 months, or failed due to intolerance, or unable to obtain medication.\n5. If a subject is currently receiving:\n\n   1. A renin-angiotensin-aldosterone inhibitor, (including direct renin inhibitors, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and mineralocorticoid receptor blockers), the subject must be on a stable dose for at least 8 weeks prior to screening. A sodium-glucose cotransporter-2 (SGLT2) inhibitor, the subject must be on a stable dose for at least 8 weeks prior to screening.\n   2. Regarding oral corticosteroid, doses \\<0.5 mg/kg prednisone equivalent at the time of enrollment are required. Steroid taper to ≤10 mg prednisone equivalent prior to lymphodepleting chemotherapy is recommended.\n\nChronic GVHD specific inclusion criteria\n\n1. The patient has a history of steroid resistant chronic graft versus host disease (SR- chronic GVHD) or is intolerant of or has unacceptable complications with steroids.\n\n   Definition of SR-chronic GVHD - Chronic GVHD that does not respond adequately to full-dose prednisone. Any of the following conditions would be considered SR-chronic GVHD:\n   * Progressive symptoms / manifestations of chronic GVHD despite receiving prednisone 1 mg/kg/day (or equivalent) for two weeks\n   * Stable symptoms / manifestations of chronic GVHD after four to six weeks of prednisone ≥0.5 mg/kg/day (or equivalent)\n   * Inability to taper prednisone to \\<0.5 mg/kg/day (or equivalent) without worsening of symptoms / manifestations of chronic GVHD\n2. Disease activity:\n\n   • Manifestations/symptoms of chronic GVHD rated as moderate to severe on the NIH chronic GVHD global severity score.\n3. Manifestations/symptoms of chronic GVHD that have not adequately responded or intolerant to both:\n\n   * Ruxolitinib\n   * Belumosudil.\n4. May be receiving adrenal replacement doses of corticosteroids\n\nInclusion Criteria: For SLE, SSc, and chronic GVHD\n\n1. Able to provide informed consent.\n2. Age ≥18 to ≤80 years.\n3. Adequate organ function i) Peripheral blood absolute neutrophil count (ANC) ≥ 1 × 109/L, unless the neutropenia is deemed to be caused by the underlying autoimmune disease.\n\nii) Hemoglobin ≥ 8 g/dl, unless the anemia is deemed to be caused by the underlying autoimmune disease.\n\niii) Platelet count ≥ 50 × 109/L without platelet transfusion support, unless the thrombocytopenia is deemed to be caused by the underlying autoimmune disease. No clinically significant active bleeding.\n\niv) Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) and total bilirubin ≤ 3 × ULN (or direct bilirubin ≤ 3 × ULN with documented Gilbert's syndrome).\n\nv) Oxygen saturation (SaO2) ≥ 92% on room air (as measured by forehead probes in SSc patients).\n\nvi) Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n\nvii) Adequate renal function, defined as serum creatinine ≤ 2x ULN and estimated Glomerular Filtration Rate (eGFR using the CKD-EPI equation) ≥ 30 ml/min/1.73 m2 5. Recovery to ≤ Grade 1 or baseline of any non-hematological toxicities due to prior therapy.\n\n6\\. Negative pregnancy test in WOCBP. 7. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of therapy. Acceptable forms of birth control for female patients include hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor. Participant is willing and able to adhere to the study visit schedule and other protocol requirements and willing to sign informed consent.\n\nExclusion Criteria:\n\nSSc specific exclusion criteria\n\n1. SSc related pulmonary arterial hypertension (PAH) requiring active treatment.\n2. Rapidly progressive SSc related lower GI (small and large intestines) involvement (requiring parenteral nutrition); active gastric antral vascular ectasia.\n3. Prior scleroderma renal crisis.\n4. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\< 40% or FVC \\< 40% of predicted or O2 saturation \\< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.\n\n   SLE specific Exclusion Criteria\n\n   Subjects are excluded from the study if any of the following criteria apply:\n5. For LN subjects only: Evidence of severe chronicity on kidney biopsy, defined as a modified National Institute of Health chronicity index score of 3+ for any of the following\n\n   individual biopsy features: total glomerulosclerosis score, fibrous crescents, tubular atrophy, or interstitial fibrosis.\n6. The presence of biopsy-proven kidney disease other than active lupus nephritis\n7. Severe pulmonary dysfunction with a hemoglobin corrected DLC0 \\< 40% or FVC \\< 40% of predicted or O2 saturation \\< 92% at rest without supplemental oxygen as measured by forehead oxygen pulse oximetry.Active, severe cardiac manifestations of SLE, including constrictive pericarditis, hemodynamically significant pericardial effusions, and myocarditis at the time of screening.\n\n   Exclusion Criteria for Chronic GVHD\n8. Treatment with any immunosuppressive drug (except steroids) within 5 half lives prior to administration of lymphodepleting therapy.\n\n   Immunosuppressive Drug Five Half Lives Half Life of the Drug Axatilimab 23 days 108 hours Belumosudil 4 days 19 hours Cyclophosphamide 3 days 3-12 hours Ibrutinib 2 days 4-6 hours Ruxolitinib 2 days 5.8 hours Sirolimus 13 days 62 hours Tacrolimus 8 days 2.1-36 hours Tocilizumab 9 weeks 5-13 days\n9. Receiving any immunosuppressive medications that are not being used for management of chronic GVHD.\n10. Treatment with steroids ≥0.5 mg/kg prednisone daily or equivalent at the time of enrollment and \\>10 mg prednisone daily or equivalent at the time of lymphodepletion.\n11. Received rituximab within 6 months of lymphodepletion.\n\n    Exclusion Criteria for SLE, SSc, and chronic GVHD\n\n    Subjects are excluded from the study if any of the following medical conditions apply:\n12. Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or unwillingness or inability to follow the procedures required in the protocol.\n13. Active, clinically significant central nervous system pathology\n14. Prior history of malignancies or lymphoproliferative disease, following are allowed: Basal or squamous cell carcinoma of the skin, Carcinoma in situ of the cervix or breast or Smoldering Myeloma. History of malignancy that has been treated with a curative intent and is in remission may be allowed after discussion with PI.\n15. Active hepatitis C, active syphilis, any human immunodeficiency virus (HIV), human lymphocytic T-cell virus type 1 and/or type 2 (HTLV-1 and/or HTLV-2\n16. Uncontrolled systemic fungal, bacterial, viral, or other infection despite appropriate anti- infective treatment at screening or within 72 hours before LD chemotherapy, or 5 days before AD-PluReceptor administration.\n17. History of any one of the following cardiovascular conditions within the 6 months prior to screening: Class III or IV heart failure as defined by the New York Heart Association, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n18. Prior CAR T cell therapy, genetically modified T cell therapy.\n19. Treatment with cyclophosphamide within 3 days, tocilizumab within 9 weeks, and/or any other immunosuppressive drug (excluding steroids) within 5 half-lives prior to administration of lymphodepleting chemotherapy. Immunosuppressive medications are allowed if not being used for management of SLE, LN or SSc.\n20. Treatment with mycophenolate mofetil within 4 days prior to administration of lymphodepleting chemotherapy. For patients who will receive tafasitamab alone may continue mycophenolate mofetil throughout the study.\n21. History of anaphylactic or severe systemic reaction to FLU, CY, Tafasitamab, or any of their metabolites.\n22. Uncontrolled infection at screening.\n23. Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal (on TPN), pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n24. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chitra Chitra Hosing, MD","phone":"(713) 745-3219","email":"cmhosing@mdanderson.org"}],"primaryOutcomes":["Adverse Event"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Tafasitamab for Autoimmune Disorders","inPlainEnglish":"The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN. The goal of Phase 1 is to find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab and lymphodepleting chemotherapy that can be given to patients with the disease.","whoItsFor":["Ages 18 Years to any","SSc Specific who can join","A. Diagnosis of SSc defined as follows:","i) Fulfilling 2013 American College of Rheumatology (ACR)and European League Against Rheumatism classification (EULAR) criteria for SSc.46 ii) Antinuclear Antibody (ANA) by immunofluorescence positive at titer ≥ 1:80 at screening or prior to screening","B. SSc disease activity i) Diffuse SSc meeting the following criteria:","Progressive ILD as defined by Raghu et al47 (≥ 2 of the following):","(i) Increased extent or severity of traction bronchiectasis and bronchiolectasis","(ii) New ground-glass opacity with traction bronchiectasis (iii) New fine reticulation (iv) Increased extent or increased coarseness of reticular abnormality"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Tafasitamab, Fludarabine phosphate, or Cyclophosphamide. The registry lists allocation as randomized. The goal of Safety Lead-In is to confirm the safety of tafasitamab when given to patients with SSc, SLE, and LN.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 47 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.509Z"},{"nctId":"NCT06439082","title":"A Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)","officialTitle":"A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) Versus Placebo, With or Without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"A phase III, multi-center, randomized, placebo-controlled, double-blind study to assess efficacy and safety of crizanlizumab (5 mg/kg) versus placebo, with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.","conditions":["Sickle Cell Disease"],"keywords":["Sickle Cell Disease","SCD","SEG101","Crizanlizumab","Hydroxyurea/ Hydroxycarbamide Therapy","Vaso-Occlusive Crises","Sickle Cell Anemia","blood disorders","hemoglobin","red blood cells","sickle-like shape","mutation in hemoglobin gene","sickle-cell trait","sickle-cell crisis"],"interventions":[{"type":"BIOLOGICAL","name":"Crizanlizumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":354,"startDate":"2024-10-24","completionDate":"2029-07-02","sex":"ALL","minAge":"12 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participants must be aged 12 years and older on the day of signing informed consent. Adolescents include participants aged 12 to \\<18 years old and adults include participants aged 18 years and older.\n2. Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible.\n3. Experienced 4 to 12 VOCs (refer to Section 8.3.1 for study definition of VOC) that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to the screening visit. Baseline VOCs are determined by medical history and are required to be documented at source.\n4. If the participant is on HU/HC, they must be taking it for at least 6 months and at stable dose for at least 3 months prior to the Screening visit and plan to continue taking it at the same dose and schedule until at least the participant has reached 52 weeks of the planned study treatment. Participants who have initiated HU/HC 6-12 months prior to the screening visit must have evidence of insufficient control of acute pain despite initiation. These participants must have a cumulative of 4-12 VOCs in the 12 months prior to the screening period, with at least 2 during the last 6 months while on HU/HC. If receiving erythropoietin stimulating agent, the participant must have been receiving the drug for at least 6 months prior to screening visit and plan to continue taking the drug at the same dose and schedule until the participant has reached 52 weeks of the planned study treatment.\n\nParticipants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit.\n\nKey Exclusion Criteria:\n\n1. Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source.\n2. History of stem cell transplant and/or gene therapy.\n3. Received blood products within 30 days prior to Week 1 Day 1 dosing.\n4. Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded.\n5. Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted.\n6. Contraindication or hypersensitivity to any drug or metabolites from similar class as study drug or to any excipients of the study drug formulation. History of severe hypersensitivity reaction to other monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction.","locations":[{"facility":"University Of Alabama","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ctr for Inherited Blood Disorders","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens National Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University Georgia","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WCG Sonar Clinical Research","city":"Riverdale","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uni of Illinois Hospital and HSC","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Children s Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Johns Hopkins University School of Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Specialty Research","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hospital at Montefiore","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Baptist Medical Center","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spoknwrdclinicaltrials","city":"Easton","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Thomas Jefferson University Me","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Childrens Cancer and Hematology Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"U of TX Health Science Ct","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Luís","state":"Maranhão","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sao Jose Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Cali","state":"Valle del Cauca Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Montería","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ahero","state":"Kisumu County","country":"Kenya","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Eldoret","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kisumu","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Siaya","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Masaka","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tororo","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","orange-california","washington-d-c-district-of-columbia","jacksonville-florida","augusta-georgia","riverdale-georgia","chicago-illinois","louisville-kentucky","baltimore-maryland","flowood-mississippi","the-bronx-new-york","greenville-north-carolina","winston-salem-north-carolina","easton-pennsylvania","philadelphia-pennsylvania","houston-texas","salvador-brazil","s-o-lu-s-brazil","campinas-brazil","ribeir-o-preto-brazil","sao-jose-rio-preto-brazil","s-o-paulo-brazil","medell-n-colombia","cali-colombia","monter-a-colombia","ahero-kenya","eldoret-kenya","kisumu-kenya","siaya-kenya","kampala-uganda","masaka-uganda","tororo-uganda"],"enrichment":{"headline":"Phase 3: testing Crizanlizumab for Sickle Cell Disease","inPlainEnglish":"A phase III, multi-center, randomly assigned, compared with a dummy treatment, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of crizanlizumab (5 mg/kg) versus dummy treatment (placebo), with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.","whoItsFor":["Ages 12 Years to 100 Years","Confirmed diagnosis of SCD by Hb electrophoresis or high-performance liquid chromatography (HPLC) (performed locally or by central laboratory if not available locally). All SCD genotypes are eligible","Participants who have not been receiving HU/HC, and/or erythropoietin stimulating agent must not have received it for at least 6 months prior to screening visit"],"whoShouldSkip":["Fewer than 4 or more than 12 VOCs that are HCP-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) within the 12 months prior to screening visit as determined by medical history and documented at source","History of stem cell transplant and/or gene therapy","Received blood products within 30 days prior to Week 1 Day 1 dosing","Any documented history of a clinical stroke or intracranial hemorrhage, or an uninvestigated neurologic finding within the past 12 months before screening visit. Silent infarct only present on imaging is not excluded","Participating in a chronic transfusion program (pre-planned series of transfusions for prophylactic purposes) and/or planning to undergo an exchange transfusion during the duration of the study; episodic transfusion in response to worsened anemia or VOC is permitted"],"whatHappens":"If you join, the listed intervention(s) are Crizanlizumab, or Placebo. The registry lists allocation as randomized. A phase III, multi-center, randomly assigned, compared with a dummy treatment, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of crizanlizumab (5 mg/kg) versus dummy treatment (placebo), with or without hydroxyurea/hydroxycarbamide therapy, in adolescent and adult Sickle Cell Disease patients with frequent vaso-occlusive crises.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 354 people at 33 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.830Z"},{"nctId":"NCT06442423","title":"Open-Label Psilocybin Study in Transdiagnostic Population","officialTitle":"Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing. The investigators will recruit individuals with mood, anxiety, trauma, addictive, or related symptomatology, and who have functional impairment associated with these symptoms. A DSM-5 diagnosis is not required (nor is it an exclusion). The investigators will allow for comorbidity and only exclude based on psychological and physiological safety considerations. Critically, this approach will allow us to assess the tolerability of our interventions in individuals who would typically be excluded from efficacy studies due to various comorbid DSM-5 conditions.\n\nThe investigators will employ an open-label study where participants will be given one dose of oral psilocybin 25mg. The investigators will also have follow-up visits at 1, 4, and 6 weeks and an optional long-term follow-up at 3, 6, and 12 months.","conditions":["Transdiagnostic","Depression - Major Depressive Disorder","Anxiety","PTSD Symptoms","PTSD","Substance Use","Substance Use Disorder (SUD)","OCD"],"keywords":["depression","anxiety","substance use","addiction","PTSD","OCD","psilocybin","psychedelic"],"interventions":[{"type":"DRUG","name":"Psilocybin"}],"enrollment":50,"startDate":"2024-10-17","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least \"mild\" impairment) and/or the WHODAS-2.0 12-item (a raw score of \\>16) - assessment instruments indexing health and disability.\n2. English fluency - able to understand the process of consent and the risk and benefits associated with the study, and able to provide written (signed and dated) informed consent form.\n3. Agree to set up safe transportation after leaving the site following the dosing session. Acceptable arrangements include: arranging for a friend/family member to drive them home, pick them up and escort them home; if the participant is unable to arrange for a friend/family member to escort them home, the study staff will arrange private transportation and follow up with the participant to ensure that they arrived at their destination.\n4. Must be able to identify a physician/treater that can be contacted to further assure that it is safe for the subject to participate and agree to sign a medical release for the investigators to communicate directly with this outside provider to confirm treatment and medical history via phone and/or email.\n5. Ability to orally ingest pills for psilocybin dosing visit.\n6. Must provide an adult contact (relative, spouse, close friend or other caregiver) who is willing and able to be reached by the PI and/or study personnel in the event of an emergency, and who can provide transportation for study visits if necessary and independently comment on any changes in the participant's mood or behavior after the administration of psilocybin. Be medically stable (no medical issues based on physical exam, labs and medical evaluation) as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an ECG, and routine blood and urinalysis laboratory tests (see section 6.3.4 for labs). Must also demonstrate decisional capacity based on clinical assessment ensuring the participant can understand, appreciate, and reason through the study's purpose, procedures, and associated risks, as well as tolerate the potential effects of the study medication.\n7. Be psychologically stable: Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in the study (up to 4-weeks post-dosing).\n8. If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session (see Section 6.3.3).\n\nIf participant is of childbearing potential, must have a negative urine pregnancy test at study entry and prior to the dosing session. Participants who are FOCBP must not plan to become pregnant or donate eggs, starting at least 1 month before receiving the trial intervention and for at least 1 week after the final follow-up visit.\n\nA FOCBP is defined as a female who is considered fertile following menarche and until becoming postmenopausal, unless permanently sterile (see below).\n\nFemales in the following categories are not considered FOCBP:\n\n* Premenarchal.\n* Premenopausal with 1 of the following:\n\n  1. Documented hysterectomy or bilateral salpingectomy/tubal occlusion/oophorectomy.\n  2. Postmenopausal.\n* A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n* Females receiving hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the nonhormonal, highly effective contraception methods if they wish to continue their HRT during the trial.\n\nExclusion Criteria:\n\nPsychiatric Exclusion Criteria:\n\n1. Personal history of a primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder, or at least one first-degree relative with a diagnosis of primary psychotic disorder (e.g., schizophrenia, delusional disorder, schizoaffective disorder) or Bipolar I disorder.\n2. Active suicidal intent or suicidal or non-suicidal self-injurious behaviors, as defined by a \"yes\" response to question 4 on C-SSRS within the past 6 months at screening or prior to dosing (Active Suicidal Ideation with Some Intent to Act, with or without Specific Plan).\n3. Use of a classic psychedelic (i.e., LSD, psilocybin, DMT, mescaline) within the 3 months prior to enrollment (not including microdosing).\n4. Use of ketamine within the past month at Screening.\n5. History of regular and frequent use of a classic psychedelic (more than 10 times per year) in a structured, intentional setting over the past 10 years. Structured use refers to participation in organized retreats, ceremonies, or church services. Microdosing is not included.\n6. History of Other Hallucinogen Use Disorder.\n7. History of intolerance to drugs known significantly to alter perception (i.e., psilocybin, LSD, salvinorium A, mescaline).\n8. Patients taking 5-hydroxytryptophan or St. John's Wort\n9. A positive breathalyzer test\n10. A positive urine toxicology screening, which detects the standard panel of five drugs (marijuana, cocaine, opioids/opiates, amphetamines, and phencyclidine (PCP)), as well as benzodiazepines, 3,4-methylenedioxymethamphetamine (MDMA). If a participant tests positive for any of these substances, the PI may request a retest during the screening phase. The exceptions to the exclusion are prescribed opioid pain medication and benzodiazepines, or over-the-counter non-narcotic pain medication. If a participant is prescribed benzodiazepines, the participant will be asked to refrain from taking on the day of the psilocybin dosing session. Additionally, participants will not be excluded from the study based on the use of cannabis. However, they will be instructed to refrain from use of cannabis on the day before, day of, and day following the drug administration session. Participants whose primary clinical presenting issue is substance use-related will not be excluded based on a positive test at screening but will be expected to adhere to the dosing day drug test produces (outlined in section 6.3.6).\n11. Changes to psychotropic medication and/or dosages within the past 3 months.\n12. Current or recent (within 2 weeks of enrollment) prescription of MAOI, Lithium, and/or methadone use.\n13. Has a psychiatric condition that precludes the establishment of therapeutic rapport as evidenced by long-term patterns of unstable relationships, a history of significant stress- related paranoia, or identity disturbances.\n14. Use of any other investigational drugs within 30 days prior to Screening.\n15. Allergy to gelatin.\n\nGeneral Medical/Laboratory Exclusion Criteria:\n\n1. Hypertension at screening is defined as: systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg, on the lowest of three measurements.\n2. History of cardiovascular disease, including but not limited to clinically significant coronary artery disease, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, angina pectoris, coronary artery bypass graft or artificial heart valve, stroke, transient ischemic attack, or any clinically significant arrhythmia.\n3. Any clinically significant abnormal electrocardiogram (ECG) finding, such as findings suggestive of ischemia or infarct, complete bundle branch block, atrial fibrillation or other symptomatic arrhythmias, or predominantly non-sinus rhythm, at Screening.\n4. Resting QT interval with Fridericia's correction (QTcF) ≥ 450 msec (male) or ≥ 470 msec\n\n   a. (female) at Screening, or inability to determine QTcF interval.\n5. Presence of risk factors for torsades de pointes, including: long QT syndrome, uncontrolled hypokalemia or hypomagnesemia, history of cardiac failure, history of clinically significant/symptomatic bradycardia, family history of idiopathic sudden death or congenital long QT syndrome, or concomitant use of a torsadogenic medication.\n6. Moderate-to-severe hepatic impairment, defined as a Child-Pugh score ≥ 5, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 x the upper limit of normal (ULN), or bilirubin \\> 1.5 x ULN, unless this is attributable to Gilbert's syndrome\n7. Use of vasoconstrictive medications (i.e. sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days and use of steroids or certain other immunomodulatory agents (i.e. azathioprine) in the past 2 weeks.\n8. Moderate-to-severe renal impairment, defined as an estimated glomerular filtration rate of \\< 50 mL/min/1.73 m2 at Screening\n9. Uncontrolled diabetes with an HbA1c \\> 8\n10. Significant uncontrolled hypothyroidism (thyroid stimulating hormone \\[TSH\\] \\< 0.8 x lower limit of normal) with the exception of stably treated hypothyroidism and uncontrolled hyperthyroidism (thyroid stimulating hormone \\[TSH\\] \\< 0.8 x \\> 1.5 x upper Any other condition, disorder or finding which in the opinion of the investigator would adversely impact participant safety or the ability of the participant to complete the study, including compliance with all study requirements and procedures.","locations":[{"facility":"Connecticut Mental Health Center - Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Shnayder","phone":"(203) 737-3404","email":"enact@yale.edu"}],"primaryOutcomes":["Columbia-Suicide Severity Rating Scale (C-SSRS)","Adverse Events Log"],"hasResults":false,"conditionSlugs":["als","depression","ptsd"],"drugSlugs":["psilocybin"],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Phase 1: testing Psilocybin for Transdiagnostic","inPlainEnglish":"The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms. The secondary objective of this study is to determine whether individuals with functional impairments due to psychiatric symptoms will experience statistically significant symptom reduction and functional improvement from baseline symptom measurements (Visit 3) to 1-week (Visit 7), 4-weeks (Visit 8), and 6-weeks (Visit 9) post dosing.","whoItsFor":["Ages 18 Years to any","At least one psychiatric symptom causing functional impairment over the past 30 days as established by a trained rater on the DIAMOND (at least \"mild\" impairment) and/or the WHODAS-2.0 12-item (a raw score of \\>16) - assessment instruments indexing health and disability","Ability to orally ingest pills for psilocybin dosing visit","Be psychologically stable: Concurrent psychotherapy is allowed if the type and frequency of the therapy has been stable for at least one month prior to screening and is expected to remain stable during participation in the study (up to 4-weeks post-dosing)","If participant is of childbearing potential, must agree to use adequate birth control and not attempt to become pregnant during study up to 4 weeks post dosing session (see Section 6.3.3)","A FOCBP is defined as a female who is considered fertile following menarche and until becoming postmenopausal, unless permanently sterile (see below)","Females in the following categories are not considered FOCBP:","Premenopausal with 1 of the following:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Psilocybin. The registry lists allocation as na. The primary objective of this study is to investigate the safety, feasibility, and tolerability of psilocybin treatment in individuals with functional impairment due to psychiatric symptoms.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.410Z"},{"nctId":"NCT06452407","title":"Evaluating the Feasibility of elleFA App Implementation","officialTitle":"Evaluating the Feasibility of elleFA App Implementation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","sponsorClass":"OTHER","summary":"Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women. Despite this, there's currently not enough research on this disease; in Canada it takes on average 5.4 years to get a diagnosis (from when symptoms start), and once diagnosed, women often have to go through a trial-and-error process to find a treatment that can manage their symptoms. Misunderstanding symptoms and struggling with patient-provider communication both contribute to these delays in diagnosis and finding the best treatment.\n\nMobile health applications have been a promising new tool to self-track symptoms and treatments. There are several apps currently available on the market for logging chronic pain, menstrual cycles, and fertility. However, no apps exist specifically for endometriosis that look at the whole spectrum of symptoms, including pain, quality of life, and especially ease of patient-provider communication. The elleFA app is a new, personal endometriosis and health tracking app designed to improve patient-physician dialogue through more direct, efficient, and impactful communication, as patients navigate their condition.\n\nThis single-arm interventional study aims to test the feasibility of implementing the new elleFA app in a clinical setting for 6 months in pre-menopausal women 18 years and older with endometriosis, and the app's impact on patient experience. Participants will download the elleFA app on their smartphone and will be asked to complete two questionnaires through the app every month for 6 months. Participants can choose to also optionally track their daily symptoms, lifestyle, and treatments, through weekly symptom log summaries through the app.\n\nThe main study finding will be be patient adherence to using the app over a 6 month study period. Other findings will include user-reported satisfaction with the elleFA app, and the impact of elleFA app use on patient experience communicating with their healthcare team.","conditions":["Endometriosis"],"keywords":["mobile health application","app","symptom tracking","treatment tracking","self-tracking","pain","quality of life","patient-provider communication"],"interventions":[{"type":"OTHER","name":"Implementation of elleFA smartphone application"}],"enrollment":20,"startDate":"2025-12-16","completionDate":"2027-07","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Pre-menopausal women 18 years of age or older with known or suspected endometriosis\n* Undergoing medical management of endometriosis at the MUHC\n* Able to provide informed consent in French or in English\n\nExclusion Criteria:\n\n* Menopausal status\n* Pregnant or seeking pregnancy","locations":[{"facility":"McGill University Health Center","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrew Zakhari, MD","phone":"514-934-1934","email":"andrew.zakhari@mcgill.ca"},{"name":"Cassandra Della Rocca, BSc","phone":"","email":"cassandra.dellarocca@rimuhc.ca"}],"primaryOutcomes":["patient adherence to using the app"],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: Implementation of elleFA smartphone application for Endometriosis","inPlainEnglish":"Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life. Endometriosis is estimated to affect approximately 10% of women.","whoItsFor":["Ages 18 Years to any","Women only","Pre-menopausal women 18 years of age or older with known or suspected endometriosis","Undergoing medical management of endometriosis at the MUHC"],"whoShouldSkip":["Pregnant or seeking pregnancy"],"whatHappens":"If you join, the listed intervention(s) are Implementation of elleFA smartphone application. The registry lists allocation as na. Endometriosis is a chronic incurable disease where endometrial-like tissue grows outside of the uterus, and causes symptoms such as debilitating menstrual pain, pain during intercourse, infertility, constipation, and bloating, which hurts their quality of life.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Montreal. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.108Z"},{"nctId":"NCT06452498","title":"Preeclampsia Intervention Netherlands","officialTitle":"Metformin for the Prolongation of Pregnancy in Preterm Preeclampsia","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Amsterdam UMC","sponsorClass":"OTHER","summary":"The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands. Signs of preterm PE can be high blood pressure and protein in the urine in the second half of pregnancy (but before 32-34 weeks of pregnancy). Other symptoms can develop, such as problems with blood clotting and how well the blood cells, liver, lungs, and brain work. The disease can lead to serious complications for both the mother and child. The only way to cure preterm PE is to make sure the child is born, and many times, children have to be delivered (very) early (before 37 weeks). Children born (very) early can suffer from infections, breathing difficulties, and problems in their development.\n\nMetformin is a medicine used to treat high blood sugar during and outside of pregnancy. In a previous study in South Africa, women with preterm PE that used metformin were able to safely remain pregnant for an extra week. Similarly, the main goal of the Preeclampsia Intervention NetherLands (PI-NL) study is to see if patients with preterm PE in the Netherlands that use metformin can remain pregnant for a longer time than patients taking a placebo. A placebo is a look-a-like capsule that contains no active ingredients. Researchers, the treating medical team, and participants will not know which participant gets which treatment. In addition, all participants will receive the standard care that all preterm PE patients get.","conditions":["Pre-Eclampsia Onset Less Than 37 Weeks","Pre-Eclampsia","Pre-Eclampsia; Complicating Pregnancy","Pre-Eclampsia as Antepartum Condition","Pre-eclampsia or Eclampsia With Pre-existing Hypertension","Pre-Eclampsia; Affecting Fetus","HELLP Syndrome Complicating Pregnancy","HELLP Syndrome","HELLP"],"keywords":["Preterm Preeclampsia","Metformin","RCT","Placebo","Gestational Prolongation","Treatment","Pregnancy","Multicenter","Preterm","HELLP Syndrome","Hypertensive disorders of pregnancy","Preeclampsia","Randomized controlled trial"],"interventions":[{"type":"DRUG","name":"Metformin Hydrochloride"},{"type":"DRUG","name":"Placebo"}],"enrollment":180,"startDate":"2025-09-19","completionDate":"2029-03-19","sex":"FEMALE","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nAll of the following:\n\n* Aged 18 years or older\n* Singleton pregnancy\n* Gestational age between 23+0 and 31+6 weeks\n* A diagnosis of preterm preeclampsia, defined according to modified International Society for the Study of Hypertension in Pregnancy (ISSHP) classification, including only those who have proteinuria (≥300 mg of protein in a 24-hour urine specimen or a protein-creatinine-ratio \\>50 in a single urine sample)\n* Estimated fetal weight \\>400 grams\n* No clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise.\n* Ability to understand English or Dutch\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria\n\nAny of the following:\n\n* Current use of metformin or a clinical indication for the use of metformin\n* A decision for immediate delivery (including cases where corticosteroids are administered with planned delivery directly after completion of treatment) or termination of pregnancy (e.g., due to disease severity in the patient combined with a dismal prognosis for the fetus), as made by the treating multidisciplinary team and the parent(s)\n* Contraindication(s) for the use of metformin (e.g., severe renal insufficiency, acute metabolic acidosis, severe liver insufficiency)\n* Use of drugs that might interact with metformin\n* Suspicion of a major fetal anomaly and/or chromosomal abnormality\n* Unable or unwilling to (completely) understand or provide informed consent, due to language, culture, or other barriers","locations":[{"facility":"Amsterdam UMC","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"M. Khelil, MD","phone":"+31 20 566 9111","email":"PI_NL@amsterdamumc.nl"},{"name":"R.C. Painter, Prof, MD, PhD","phone":"+31 20 566 9111","email":"PI_NL@amsterdamumc.nl"}],"primaryOutcomes":["Number of days between randomization and delivery"],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["amsterdam-netherlands"],"enrichment":{"headline":"Phase 3: testing Metformin Hydrochloride for Pre-Eclampsia Onset Less Than 37 Weeks","inPlainEnglish":"The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child. Preterm PE affects about 1 in 100 pregnant individuals in the Netherlands.","whoItsFor":["Ages 18 Years to 50 Years","Women only","All of the following:","Aged 18 years or older","Singleton pregnancy","Gestational age between 23+0 and 31+6 weeks","Estimated fetal weight \\>400 grams","No clear indication (maternal or fetal) or intention, by both the treating multidisciplinary team and the patient after counseling, to immediately deliver (or directly after corticosteroid administration) or to terminate the pregnancy otherwise","Ability to understand English or Dutch"],"whoShouldSkip":["Any of the following:","Current use of metformin or a clinical indication for the use of metformin","Contraindication(s) for the use of metformin (e.g., severe renal insufficiency, acute metabolic acidosis, severe liver insufficiency)","Use of drugs that might interact with metformin","Suspicion of a major fetal anomaly and/or chromosomal abnormality"],"whatHappens":"If you join, the listed intervention(s) are Metformin Hydrochloride, or Placebo. The registry lists allocation as randomized. The goal of this study is to find out if pregnant individuals with preterm preeclampsia (PE) who are treated with metformin can stay pregnant for longer, and if this is safe(r) for the mother and child.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 180 people at Amsterdam. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.046Z"},{"nctId":"NCT06452992","title":"Microbiome and Metabolomics Profiling in Children With OSA","officialTitle":"Microbiome and Metabolomics Profiling in Children With Obstructive Sleep Apnoea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"Objectives: Obstructive sleep apnoea (OSA) exhibits variable susceptibility to end-organ morbidities. Previous studies suggest that physiological sequelae in individuals with OSA promote changes in microbiome, which also interact with metabolic and inflammatory mediators. Therefore, microbiome and metabolomic profiling could potentially reveal the pathological processes underlying OSA. The primary objectives of our study are 1)To investigate the differences in the composition of nasal and stool microbiome between children with OSA and non-OSA controls; 2)To investigate the differences in the urine metabolomic profiles between children with OSA and non-OSA controls.\n\nHypothesis to be tested: The microbiome composition and urine metabolomic profiles are different between children with OSA and non-OSA controls. Changes in microbiome composition are associated with specific urine metabolomic and inflammatory profiles in children with OSA.\n\nDesign and subjects: A prospective case-control study. Chinese children aged 6-11 years old with habitual snoring and polysomnography (PSG) confirmed OSA will be recruited as cases. Non-OSA healthy children will be recruited as controls. All subjects will undergo evaluation including questionnaires, anthropometric measurements, PSG, blood, urine, nasal and stool sampling.\n\nPrimary outcome measures: Microbiome and metabolomic profiles in children with OSA compared to non-OSA controls.\n\nAnalysis: Comparisons of the microbiome and metabolomic profiles between OSA children and controls. Correlations of microbiome and metabolomic profiles with inflammatory biomarkers and PSG measurements will be evaluated by regression analysis.\n\nExpected results: This study will provide novel data regarding microbiome and metabolomic profiles, and their relationship with inflammatory biomarkers in children with OSA.","conditions":["Obstructive Sleep Apnea"],"keywords":[],"interventions":[],"enrollment":130,"startDate":"2023-07-01","completionDate":"2027-06-30","sex":"ALL","minAge":"6 Years","maxAge":"11 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Children aged 6-11 years old\n\nExclusion Criteria:\n\n* Previous upper airway surgery, genetic or syndromal disease, congenital or acquired neuromuscular disease, suspected or confirmed congenital or acquired immunodeficiency, known metabolic syndrome, craniofacial abnormalities, structural or congenital heart disease, use of medications or therapy that could affect immunity such as systemic corticosteroids, chemotherapy, radiation therapy, intravenous immunoglobulins.","locations":[{"facility":"Prince of Wales Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kate Ching Ching Chan, MD","phone":"35053515","email":"katechan@cuhk.edu.hk"}],"primaryOutcomes":["Stool microbiome profiles","Urine metabolomic profiles"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Microbiome and Metabolomics Profiling in Children With OSA","inPlainEnglish":"Objectives: Obstructive sleep apnoea (OSA) exhibits variable susceptibility to end-organ morbidities. Previous studies suggest that physiological sequelae in individuals with OSA promote changes in microbiome, which also interact with metabolic and inflammatory mediators.","whoItsFor":["Ages 6 Years to 11 Years","Children aged 6-11 years old"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 130 people at Hong Kong. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.947Z"},{"nctId":"NCT06456450","title":"Taiwan Severe Asthma Biologic Registry","officialTitle":"Taiwan Severe Asthma Biologic Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Taichung Veterans General Hospital","sponsorClass":"OTHER","summary":"This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan.\n\nThe goal of this observational study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. Determine risk factors associated with poor asthma control.\n2. Support the development of effectiveness and safety of therapeutic principles\n3. To discover the real-world effectiveness of different biologics ( Clinical remission)\n4. To discover the impact of initiating biologics for severe asthma patients.\n5. To evaluate the prevalence of biologics switching and its benefits for patients.\n6. To compare the achievement rate of clinical remission among different biologics.\n\nParticipants who are treated either with omalizumab, mepolizumab, benralizumab dupilzumab or Tezepelumab after January 1, 2020 will be included in the study.","conditions":["Pulmonary Disease","Asthma"],"keywords":["Severe Asthma","Registry","Biologic"],"interventions":[{"type":"BIOLOGICAL","name":"Biological Treatment for severe asthma patients"}],"enrollment":500,"startDate":"2023-11-11","completionDate":"2043-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case.\n* Female and male aged over 18 years old.\n* Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020.\n\nExclusion Criteria:\n\n* Lack of informed consent for participation.\n* History of Biologic usage before January 1, 2020, should be ruled out.\n* The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation.\n* Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma.","locations":[{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pin-Kuei Fu, MD.,PhD.","phone":"886-4-23592525","email":"yetquen@gmail.com"}],"primaryOutcomes":["Status of Asthma Control","Status of Asthma exacerbations","Reduction of daily oral corticosteriod dose","Change of Pre-BD FEV1 (%pred)"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["taichung-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: testing Biological Treatment for severe asthma patients for Pulmonary Disease","inPlainEnglish":"This is a prospective multi-centers cohort study for registration adult patients with severe asthma and were reimbursed biologics treatment in Taiwan. The goal of this watch-and-measure (no experimental treatment required) study is to discover the real-world effectiveness, the impact of initiating, switching of biologics, and the possible prediction factors for selecting the best treatment option for patients.","whoItsFor":["Ages 18 Years to any","Patient should be reviewed as well as confirmed by the National Health Insurance Administration (NHIA) or by the study board member as a Severe Asthma case","Female and male aged over 18 years old","Patients who are treated either with omalizumab, mepolizumab, or benralizumab after January 1, 2020"],"whoShouldSkip":["History of Biologic usage before January 1, 2020, should be ruled out","The washout period should be at least 12 months. In other words, the enrolled patients should have no experience in receiving a biological treatment or in participating relative clinical trial before his/her biologic initiation","Comorbid pulmonary diseases (e.g.: Chronic Obstructive Pulmonary Disease, Bronchiectasis, Pulmonary Fibrosis, etc.) or risk factors (e.g.: smoking or environmental exposure, etc..) that could be associated with pulmonary or systemic diseases, other than Asthma"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Taichung. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.871Z"},{"nctId":"NCT06462196","title":"Natural History of Depression, Bipolar Disorder and Suicide Risk","officialTitle":"Natural History of Depression, Bipolar Disorder and Suicide Risk","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.","conditions":["Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar"],"keywords":["Neurobiology","Suicide","Major Depressive Disorder","Bipolar Disorder","Biomarkers","Suicide Risk","Treatment Resistant Depression"],"interventions":[],"enrollment":500,"startDate":"2024-09-09","completionDate":"2030-06-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kelly T Hurst, Ph.D.","phone":"(877) 646-3644","email":"moodresearch@mail.nih.gov"},{"name":"Elizabeth D Ballard, Ph.D.","phone":"(301) 435-9399","email":"elizabeth.ballard@nih.gov"}],"primaryOutcomes":["Score on Montgomery Asberg Depression Rating Scale"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Natural History of Depression, Bipolar Disorder and Suicide Risk","inPlainEnglish":"Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments.","whoItsFor":["Ages 18 Years to 120 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers","Age 18 years or older","Able to read and write English"],"whoShouldSkip":["Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment","Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.102Z"},{"nctId":"NCT06463743","title":"Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)","officialTitle":"Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS): Randomized, Placebo-controlled Pilot Study.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"State University of New York at Buffalo","sponsorClass":"OTHER","summary":"The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin. Metformin may be used as a single therapy or as an add-on therapy. The investigators want to learn:\n\n* The safety and tolerability of metformin extended release (1500 mg/day) as a single therapy or as an add-on therapy in older people with MS compared to placebo\n* How well metformin protects the nervous system against injury compared with placebo measured by brain MRI over a 9 month treatment period\n* The effect of metformin to protect brain tissue from age and MS related injury when compared to the placebo group over a 9 month treatment period","conditions":["Multiple Sclerosis"],"keywords":["metformin"],"interventions":[{"type":"DRUG","name":"metformin"},{"type":"DRUG","name":"Placebo"}],"enrollment":30,"startDate":"2025-09-24","completionDate":"2027-12-01","sex":"ALL","minAge":"55 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. age between 55 and 75 years old\n2. having a diagnosis of MS based on the latest McDonald criteria\n3. non-active disease course (no relapses and no MRI activity) in the last 2 years as determined by the MS provider and based on the 2020 revised clinical course criteria\n4. EDSS score \\<7.0\n\nExclusion Criteria:\n\n1. inability to undergo MRI scans\n2. inability to participate in the study during the study period\n3. diabetes or uncontrolled cardiovascular disease\n4. unable to consent","locations":[{"facility":"UBMD Neurolgy","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kara Patrick","phone":"7168295037","email":"kpatrick@buffalo.edu"}],"primaryOutcomes":["Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.","Percent change in N-Acetyl Aspartate (NAA) in the cortex over 9 months"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["buffalo-new-york"],"enrichment":{"headline":"Phase 2: testing metformin for Multiple Sclerosis","inPlainEnglish":"The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin. Metformin may be used as a single therapy or as an add-on therapy.","whoItsFor":["Ages 55 Years to 75 Years","age between 55 and 75 years old","having a diagnosis of MS based on the latest McDonald criteria","non-active disease course (no relapses and no MRI activity) in the last 2 years as determined by the MS provider and based on the 2020 revised clinical course criteria"],"whoShouldSkip":["inability to undergo MRI scans","inability to participate in the study during the study period","diabetes or uncontrolled cardiovascular disease"],"whatHappens":"If you join, the listed intervention(s) are metformin, or Placebo. The registry lists allocation as randomized. The goal of the study is to learn about treating older people with multiple sclerosis (MS) with metformin.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Buffalo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.971Z"},{"nctId":"NCT06465069","title":"A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors","officialTitle":"A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.","conditions":["Metastatic Solid Tumor","Recurrent Solid Tumor","Advanced Solid Tumor","Urinary Bladder Neoplasm","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Esophageal Cancer","Pancreatic Cancer","Ovarian Cancer","Cervical Cancer","Head and Neck Squamous Cell Carcinoma","Prostate Cancer","Renal Pelvis Cancer","Bladder Cancer"],"keywords":["Bladder Cancer","Bladder Neoplasm","Bladder Urothelial Carcinoma","Urinary Bladder Cancer","Urinary Tract Cancer","Urothelial Neoplasms","Renal Pelvis Cancer","Ureter Cancer","Nectin-4","Antibody Drug Conjugate (ADC)","Triple Negative Breast Cancer (TNBC)","Non-small Cell Lung Cancer (NSCLC)","Head and Neck Squamous Cell Carcinoma (HNSCC)"],"interventions":[{"type":"DRUG","name":"LY4052031"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":460,"startDate":"2024-07-01","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have one of the following solid tumor cancers:\n\n  * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer\n  * Cohort A2/B/D: urothelial carcinoma\n  * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer\n* Prior Systemic Therapy Criteria:\n\n  * Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies\n  * Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.\n  * Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer.\n* Prior enfortumab vedotin specific requirements:\n\n  * Cohorts A1/A2/C/D: prior treatment with enfortumab vedotin is allowed, but not required\n  * Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting\n  * Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.\n* Measurability of disease\n\n  * Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)\n  * Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations\n\nExclusion Criteria:\n\n* Individual with known or suspected uncontrolled CNS metastases\n* Individual with uncontrolled hypercalcemia\n* Individual with uncontrolled diabetes\n* Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant\n* Any serious unresolved toxicities from prior therapy\n* Significant cardiovascular disease\n* Recent thromboembolic event and/or clinically significant bleeding disorder\n* Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms\n* History of pneumonitis/interstitial lung disease\n* History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation\n* Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention","locations":[{"facility":"City of Hope National Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego (UCSD) - Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Department of Medicine-Hematology/Oncology","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at HealthOne","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists and Research Institute","city":"St. Petersburg","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IU Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest Cancer and Hematology Centers of W Michigan","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Medical Center - Perlmutter Cancer Center (NYU Cancer Institute)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology PLLC","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah - Huntsman Cancer Institute","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Vincent's Hospital","city":"Darlinghurst","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linear Clinical Research","city":"Nedlands","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital, Shanghai Jiaotong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy (Igr)","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa, Chiba","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Kōtō City","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center Hospital","city":"Nagoya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalan Institute of Oncology Duran i Reynals Hospital","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Madrid Norte Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031","Phase 1b: To assess the antitumor activity of LY4052031 as monotherapy or in combination with pembrolizumab: Overall response rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","pancreatic-cancer","ovarian-cancer","bladder-cancer","cervical-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["duarte-california","la-jolla-california","los-angeles-california","denver-colorado","st-petersburg-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","boston-massachusetts","grand-rapids-michigan","st-louis-missouri","new-york-new-york","cleveland-ohio","nashville-tennessee","houston-texas","san-antonio-texas","salt-lake-city-utah","west-valley-city-utah","darlinghurst-australia","nedlands-australia","beijing-china","guangzhou-china","shanghai-china","villejuif-france","ch-ku-japan","kashiwa-chiba-japan","k-t-city-japan","nagoya-japan","seoul-south-korea","barcelona-spain","madrid-spain","seville-spain","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 1: testing LY4052031 for Metastatic Solid Tumor","inPlainEnglish":"This study wants to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion).","whoItsFor":["Ages 18 Years to any","Have one of the following solid tumor cancers:","Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer","Cohort A2/B/D: urothelial carcinoma","Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer","Prior Systemic Therapy Criteria:","Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies","Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies"],"whoShouldSkip":["Individual with known or suspected uncontrolled CNS metastases","Individual with uncontrolled hypercalcemia","Individual with uncontrolled diabetes","Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant","Any serious unresolved toxicities from prior therapy","Significant cardiovascular disease","Recent thromboembolic event and/or clinically significant bleeding disorder"],"whatHappens":"If you join, the listed intervention(s) are LY4052031, or Pembrolizumab. The registry lists allocation as randomized. This study wants to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 460 people at 39 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.926Z"},{"nctId":"NCT06467357","title":"Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer","officialTitle":"DESTINY-Biliary Tract Cancer-01: A Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) and Rilvegostomig Versus Standard-of-Care Gemcitabine, Cisplatin, and Durvalumab for First Line Locally Advanced or Metastatic HER2-expressing Biliary Tract Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.","conditions":["Biliary Tract Cancer"],"keywords":["Biliary Tract Cancer","HER2","HER2 expressing BTC","Trastuzumab deruxtecan","T-DXd","Rilvegostomig"],"interventions":[{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Durvalumab"},{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Rilvegostomig"}],"enrollment":620,"startDate":"2024-08-12","completionDate":"2028-06-12","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Male and female patients must be at least 18 years of age at the time of signing the informed consent. Other age restrictions may apply as per local regulations.\n* Unresectable, previously untreated, locally advanced or metastatic biliary tract adenocarcinoma. Prior treatment in the perioperative and/or adjuvant setting is permissible provided there is \\> 3 months (90 days) between the end of adjuvant treatment (or surgery or radiation with curative intent) and the diagnosis of locally advanced or metastatic disease.\n* Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC.\n* Patients must provide an FFPE tumor sample that is no older than 3 years.\n* Has at least one target lesion assessed by the Investigator based on RECIST v1.1. 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Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Greater London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Da Nang","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hanoi","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Vinh","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Safety Run In: To evaluate the safety and tolerability of T-DXd with rilvegostomig","Randomized Portion: To evaluate the efficacy of T-DXd with rilvegostomig vs Standard of Care (SoC) in terms of Overall Survival in the FAS (HER2 IHC 3+) population"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["scottsdale-arizona","tucson-arizona","fullerton-california","la-jolla-california","los-alamitos-california","los-angeles-california","san-francisco-california","walnut-creek-california","washington-d-c-district-of-columbia","fort-myers-florida","jacksonville-florida","st-petersburg-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","coeur-dalene-idaho","chicago-illinois","niles-illinois","towson-maryland","boston-massachusetts","worcester-massachusetts","detroit-michigan","grand-rapids-michigan","rochester-minnesota","kansas-city-missouri","st-louis-missouri","albuquerque-new-mexico","new-york-new-york","white-plains-new-york","cleveland-ohio","columbus-ohio","pittsburgh-pennsylvania","greenville-south-carolina","nashville-tennessee","austin-texas","dallas-texas","fort-worth-texas","houston-texas","pearland-texas","san-antonio-texas","fairfax-virginia","chermside-australia","clayton-australia","concord-australia","nedlands-australia","graz-austria","linz-austria","salzburg-austria","vienna-austria","wiener-neustadt-austria","anderlecht-belgium","edegem-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","roeselare-belgium","natal-brazil","porto-alegre-brazil","santa-maria-brazil","s-o-paulo-brazil","vit-ria-brazil","edmonton-canada","halifax-canada","brampton-canada","toronto-canada","montreal-canada","beijing-china","bengbu-china","changchun-china","changde-china","changsha-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","guiyang-china","hangzhou-china","harbin-china","hefei-china","jinan-china","kunming-china","linyi-china","luoyang-china","nanchang-china","nanjing-china","nanning-china","nantong-china","shanghai-china","shenyang-china","shenzhen-china","tianjin-china","weifang-china","wenzhou-china","wuhan-china","xian-china","zhengzhou-china","brno-czechia","hradec-kr-lov-czechia","olomouc-czechia","prague-czechia","brest-france","clichy-france","dijon-france","lille-france","lyon-france","marseille-france","montpellier-france","pessac-france","villejuif-france","berlin-germany","bonn-germany","cologne-germany","dresden-germany","frankfurt-germany","freiburg-im-breisgau-germany","g-ttingen-germany","hamburg-germany","leipzig-germany","l-beck-germany","m-nchen-germany","ulm-germany","w-rzburg-germany","hong-kong-hong-kong","dehradun-india","delhi-india","kanpur-india","kolkata-india","mumbai-india","vadodara-india","varanasi-india","florence-italy","milan-italy","naples-italy","padova-italy","roma-italy","rozzano-italy","tricase-italy","bunky-city-japan","chiba-japan","fukuyama-shi-japan","hirakata-shi-japan","hiroshima-japan","kanazawa-japan","kashiwa-japan","kawasaki-shi-japan","kita-gun-japan","kitaadachi-gun-japan","k-toku-japan","kumamoto-japan","kurashiki-shi-japan","kyoto-japan","maebashi-japan","mitaka-shi-japan","nagoya-japan","osaka-japan","sakaishi-japan","sapporo-japan","sendai-japan","shinjuku-ku-japan","suita-japan","sunto-gun-japan","ube-shi-japan","wakayama-japan","yokohama-japan","george-town-malaysia","johor-bahru-malaysia","kuala-lumpur-malaysia","kuching-malaysia","rotterdam-netherlands","cebu-city-philippines","makati-philippines","pasig-philippines","quezon-city-philippines","bialystok-poland","katowice-poland","krakow-poland","lublin-poland","warsaw-poland","wroclaw-poland","dammam-saudi-arabia","riyadh-saudi-arabia","bansk-bystrica-slovakia","bratislava-slovakia","ko-ice-slovakia","martin-slovakia","trnava-slovakia","busan-south-korea","gyeonggi-do-south-korea","hwasun-gun-south-korea","seongnam-si-south-korea","seoul-south-korea","barcelona-spain","madrid-spain","m-laga-spain","santander-spain","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","taoyuan-taiwan","bangkok-thailand","hat-yai-thailand","khon-kaen-thailand","muang-thailand","mueang-thailand","naimuang-thailand","ongkharak-thailand","si-sa-ket-thailand","alt-nda-turkey-t-rkiye","antalya-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","mezitli-turkey-t-rkiye","yakutiye-turkey-t-rkiye","birmingham-united-kingdom","dundee-united-kingdom","glasgow-united-kingdom","greater-london-united-kingdom","leeds-united-kingdom","london-united-kingdom","da-nang-vietnam","hanoi-vietnam","ho-chi-minh-city-vietnam","vinh-vietnam"],"enrichment":{"headline":"Phase 3: testing Gemcitabine for Biliary Tract Cancer","inPlainEnglish":"This study wants to measure the how well it works and safety of T-DXd with rilvegostomig or T-DXd this drug alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.","whoItsFor":["Ages 18 Years to 99 Years","Histologically confirmed HER2-expressing (IHC 3+ or IHC 2+) BTC","Patients must provide an FFPE tumor sample that is no older than 3 years","Has at least one target lesion assessed by the Investigator based on RECIST v1.1. (randomly assigned portion only)","WHO/how well you can do daily activities (ECOG score) of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing","Adequate organ and bone marrow function within 14 days before randomization","Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential","Minimum life expectancy of 12 weeks"],"whoShouldSkip":["Prior exposure to other HER2 targeting therapies, ADCs, immune checkpoint inhibitors and therapeutic anticancer vaccines","Histologically confirmed ampullary carcinoma","Any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the Investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results","Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms","Active autoimmune, connective tissue or inflammatory disorders that has required systemic treatment in the past 2 years, or where there is documented, or a suspicion of pulmonary involvement at the time of screening","Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening triplicate 12-lead ECG","History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening"],"whatHappens":"If you join, the listed intervention(s) are Gemcitabine, Cisplatin, or Durvalumab. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of T-DXd with rilvegostomig or T-DXd this drug alone compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 620 people at 223 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.367Z"},{"nctId":"NCT06476678","title":"Novel Bipolar Radiofrequency Ablation Knife in Esophageal Lesions","officialTitle":"Prospective Multicenter Trial Evaluating the Efficacy and Feasibility of a Novel Bipolar Radiofrequency Ablation Knife in Esophageal Endoscopic Submucosal Dissection","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Baylor College of Medicine","sponsorClass":"OTHER","summary":"Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife. Moreover, the research team have previously reported on the clinical efficacy of the bipolar RFA knife during per-oral endoscopic myotomy (POEM) and colonic ESD. The goal of our study is to prospectively evaluate the efficacy, safety and feasibility of Esophageal ESD using a novel Bipolar-Current ESD device.","conditions":["Esophageal Neoplasm","Esophageal Polyp","Endoscopic Submucosal Dissection","Bipolar Electrocautery"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Speedboat™ Ultraslim"}],"enrollment":50,"startDate":"2024-10-15","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient is \\>18 years of age\n* Patient can provide informed consent\n* Patient is referred for resection of precancerous lesions meeting the following criteria:\n\n  * Mucosal based polyp\n  * Located gastroesophageal junction (GEJ) or proximal to GEJ\n  * No previous endoscopic resection attempted (EMR or ESD)\n\nExclusion Criteria:\n\n* Patients with International Normalized Ratio (INR) \\>1.5 or Platelets \\<50,000\n* Lesions extending past GEJ\n* Subepithelial lesions","locations":[{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Salmaan A Jawaid, MD","phone":"7137980950","email":"Salmaan.Jawaid@bcm.edu"},{"name":"Haydee Rochits Cueto","phone":"7137983606","email":"Haydee.RochitsCueto@bcm.edu"}],"primaryOutcomes":["Technical success"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Speedboat™ Ultraslim for Esophageal Neoplasm","inPlainEnglish":"Both Baylor St Luke's Medical Center and Mayo Scottsdale are considered endoscopic submucosal dissection (ESD) centers of excellence. The investigators at Baylor College of Medicine have previously reported our Esophageal ESD experience using the monopolar current knife.","whoItsFor":["Ages 18 Years to any","Patient is \\>18 years of age","Patient is referred for resection of precancerous lesions meeting the following criteria:","Mucosal based polyp","Located gastroesophageal junction (GEJ) or proximal to GEJ","No previous endoscopic resection attempted (EMR or ESD)"],"whoShouldSkip":["Patients with International Normalized Ratio (INR) \\>1.5 or Platelets \\<50,000","Lesions extending past GEJ","Subepithelial lesions"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at Houston. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.729Z"},{"nctId":"NCT06477653","title":"Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents","officialTitle":"A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nHypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs. The current primary treatment for HES can cause serious side effects. Secondary treatments do not work in all people.\n\nObjective:\n\nTo test an approved drug (dupilumab), combined with other drugs, in people with HES.\n\nEligibility:\n\nPeople aged 18 years and older who take drugs (mepolizumab, reslizumab, or benralizumab) to treat HES.\n\nDesign:\n\nParticipants will have up to 6 clinic visits and 7 remote visits in up to 48 weeks.\n\nParticipants will be screened. They will have blood and urine tests. They will have a test of their heart function. They will take surveys about how HES affects their daily life. Some participants may have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle.\n\nParticipants will have other tests specific to their symptoms. For example, those with symptoms affecting their lungs will have breathing tests. Others may have tests that target symptoms in their sinuses, gastrointestinal tract, or skin.\n\nDupilumab is injected under the skin once every 1 or 2 weeks. Dose and timing will vary among participants. They will be taught how to inject themselves at home between clinic visits. They will take dupilumab plus their current medications for 24 weeks. If the drug is helping them, they will continue taking it for another 24 weeks.\n\nParticipants will have a final visit 12 weeks after their last dose.","conditions":["Hypereosinophilic Syndrome"],"keywords":["Hypereosinophilic Syndrome","Eosinophil","Monoclonal Antibody","Clinical Trial","Treatment"],"interventions":[{"type":"BIOLOGICAL","name":"dupilumab"}],"enrollment":30,"startDate":"2025-02-05","completionDate":"2026-12-30","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all the following criteria:\n\n1. Age \\>=18 years\n2. Documented diagnosis of HES with historic AEC\\>1.5x10\\^9/L on two occasions, no secondary etiology for the eosinophilia despite careful clinical evaluation, and evidence of end organ damage (histologic evidence of tissue infiltration by eosinophils and/or objective evidence of clinical pathology in any organ system that is temporally associated with eosinophilia and not clearly attributable to another cause)\n3. Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 24 weeks\n4. AEC\\<0.5x10\\^9/L\n5. Residual symptoms after a minimum of 24 weeks of eosinophil-lowering biologic therapy with at least 1 most bothersome symptom of moderate severity (HES-SI score \\>=2) consistent with \\>=1 of the following diagnoses:\n\n   a. asthma, defined as physician-documented asthma requiring medium to high dose inhaled corticosteroids + long-acting beta agonist b. atopic dermatitis, defined as physician-documented chronic or recurrent inflammatory skin disease\n\n   c. CRSwNP, defined as evidence of rhinosinusitis and nasal polyposis on physical examination or imaging\n\n   d. EoE, defined as biopsy-proven esophageal eosinophilia \\>15 eosinophils/high power field\n6. For participants who can become pregnant: sexual abstinence or use of highly effective contraception (i.e., partner vasectomy, bilateral tubal ligation, IUD, progestin implants, and other hormonal methods) starting 4 weeks prior to study drug initiation and agreement to use such a method during study participation and for an additional 12 weeks after the end of study drug administration\n7. Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)\n8. Ability of subject to understand and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnancy or lactation\n2. Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM)\n3. Febrile illness within 7 days of enrollment\n4. Treatment with an investigational drug or other intervention other than mepolizumab, reslizumab, or benralizumab within 12 weeks or 4 half-lives of the investigational agent (whichever is longer).\n5. Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection\n6. Known diagnosis of eosinophilic granulomatosis with polyangiitis\n7. Change in eosinophil-active therapy within the past 6 weeks, including but not limited to topical corticosteroids, leukotriene inhibitors, initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food (in patients with gastrointestinal involvement), and proton pump inhibitors (in patients with gastrointestinal involvement)\n8. Planned or anticipated major surgical procedure during the study\n9. Active parasitic infection\n10. History of malignancy within 5 years, excluding completely treated in situ carcinoma of the cervix, or squamous or basal cell carcinoma of the skin\n11. Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study\n\nFor patients with eosinophilic gastrointestinal disease only:\n\n1. Active infection with Helicobacter pylori\n2. History of achalasia, Crohn s disease, ulcerative colitis, celiac disease, or prior esophageal surgery\n3. Any esophageal stricture unable to be passed with a standard, diagnostic, 9 to 10 mm upper endoscope","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amy D Klion, M.D.","phone":"(240) 381-6073","email":"amy.klion@nih.gov"}],"primaryOutcomes":["Clinical improvement on dupilumab therapy as assessed by HES-MBS (HES-most bothersome symptom) and HES-SI (HES-Symptom Inventory)."],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing dupilumab for Hypereosinophilic Syndrome","inPlainEnglish":"Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils. HES can damage the lungs and airways, intestines, skin, and other organs.","whoItsFor":["Ages 18 Years to 99 Years","To be eligible to participate in this study, an individual must meet all the following criteria:","Currently receiving treatment with an eosinophil-lowering biologic (mepolizumab, reslizumab, or benralizumab) for a minimum of 24 weeks","Residual symptoms after a minimum of 24 weeks of eosinophil-lowering biologic therapy with at least 1 most bothersome symptom of moderate severity (HES-SI score \\>=2) consistent with \\>=1 of the following diagnoses:","a. asthma, defined as physician-documented asthma requiring medium to high dose inhaled corticosteroids + long-acting beta agonist b. atopic dermatitis, defined as physician-documented chronic or recurrent inflammatory skin disease","c. CRSwNP, defined as evidence of rhinosinusitis and nasal polyposis on physical examination or imaging","d. EoE, defined as biopsy-proven esophageal eosinophilia \\>15 eosinophils/high power field","Participation in NIH protocol 94-I-0079 (Activation and function of eosinophils in conditions with blood or tissue eosinophilia)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Pregnancy or lactation","Known allergic reaction to dupilumab or any of the excipients in Dupixent(TM)","Febrile illness within 7 days of enrollment","Treatment with an investigational drug or other intervention other than mepolizumab, reslizumab, or benralizumab within 12 weeks or 4 half-lives of the investigational agent (whichever is longer)","Known or suspected acquired or inborn immunodeficiency disorder, including HIV infection","Known diagnosis of eosinophilic granulomatosis with polyangiitis"],"whatHappens":"If you join, the listed intervention(s) are dupilumab. The registry lists allocation as randomized. Background: Hypereosinophilic syndrome (HES) is a blood disorder that causes high levels of white blood cells called eosinophils.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Bethesda. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.702Z"},{"nctId":"NCT06477952","title":"DRonabinol Treatment of OSA","officialTitle":"Targeted Treatment of Obstructive Sleep Apnea With Dronabinol: Proof of Concept and Phase II Clinical Trial","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks. Sleep studies will be conducted before and after treatment to measure OSA severity.","conditions":["Obstructive Sleep Apnea"],"keywords":["OSA","sleep apnea","pharmacological treatment","Drug treatment"],"interventions":[{"type":"DRUG","name":"Dronabinol"}],"enrollment":120,"startDate":"2025-08-25","completionDate":"2027-03-31","sex":"ALL","minAge":null,"maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\. AHI 15-50 per hour on pre-treatment polysomnography\n\nExclusion Criteria:\n\n1. Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (OSA): use \\> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data\n2. Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \\> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report\n3. History of upper airway surgery for OSA (except adenotonsillectomy)\n4. Central or mixed apneas \\>25% of respiratory events on diagnostic polysomnography\n5. Arterial oxygen saturation \\< 75% for \\> 5% sleep time on pretreatment polysomnography\n6. Body mass index \\> 45 kilograms per square meter (kg/m2)\n7. If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug\n8. Active enrollment in a weight loss program\n9. Shiftwork within 3 months of enrollment\n10. High-risk occupation: commercial driver and pilot\n11. Motor vehicle accident or near-miss incident within 1 year of enrollment\n12. Current drug or habitual alcohol use or positive urine drug screen\n13. Comorbid medical and psychiatric disorders:\n\n    1. Primary sleep disorders: e.g., narcolepsy, restless legs syndrome\n    2. Uncontrolled mood disorder or a diagnosis of schizophrenia\n    3. Initiation of new antidepressant or antipsychotic medication within 3 months\n    4. Identified as high-risk for suicide in electronic health records\n    5. Uncontrolled medical disorders (coronary heart disease, arrhythmia, congestive heart failure, chronic obstructive pulmonary disease, chronic hypoxemic or hypercapnic respiratory failure, stroke within 6 months of enrollment, chronic liver or kidney disease, autoimmune disorders)\n14. Use of sedative-hypnotic medications within 30 days of enrollment\n15. Complete blood count or liver function test values more than 1.5 times the upper limit of normal\n16. Pregnancy\n17. Allergy to cannabinoids or sesame oil\n18. Average weekly alcohol consumption of more than 10 servings\n19. Participation in other investigational protocols within 30 days of enrollment","locations":[{"facility":"Jesse Brown VA Medical Center, Chicago, IL","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bharati Prasad, MD","phone":"(312) 996-8433","email":"bharati.prasad@va.gov"},{"name":"Karen M Lenehan","phone":"(312) 569-6343","email":"Karen.Lenehan@va.gov"}],"primaryOutcomes":["Apnea Hypopnea Index (AHI)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Dronabinol for Obstructive Sleep Apnea","inPlainEnglish":"This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA). All participants will take oral Dronabinol for two weeks.","whoItsFor":["Ages any to 65 Years","1\\. AHI 15-50 per hour on pre-treatment polysomnography"],"whoShouldSkip":["Positive Airway Pressure (PAP) treatment of obstructive sleep apnea (OSA): use \\> 4 hours per day for 30% of days within 3 months of enrollment. PAP use will be determined from device download data","Hypoglossal nerve stimulator (HNS) or oral appliance device treatment with use \\> 4 hours per day for 30% of days within 3 months of enrollment. HNS use will be determined by device download and oral appliance use by self-report","History of upper airway surgery for OSA (except adenotonsillectomy)","Central or mixed apneas \\>25% of respiratory events on diagnostic polysomnography","Arterial oxygen saturation \\< 75% for \\> 5% sleep time on pretreatment polysomnography","Body mass index \\> 45 kilograms per square meter (kg/m2)","If post-bariatric surgery, weight must be stable ±5% (per electronic medical records) for at least 6 months before the first dose of the study drug"],"whatHappens":"If you join, the listed intervention(s) are Dronabinol. The registry lists allocation as na. This is an open-label trial that tests the effectiveness of Dronabinol in treating obstructive sleep apnea (OSA).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.940Z"},{"nctId":"NCT06480201","title":"Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression","officialTitle":"Gamma Oscillations as a Prognostic Marker for Ketamine Therapy in Treatment Resistant Depression","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Texas A&M University","sponsorClass":"OTHER","summary":"The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion. Our study design captures the clinical variation associated with real-world treatment resistant depression (TRD) patients and allows us to analyze the relative importance of GBP to antidepressant symptom reduction across the induction phase of treatment. If successful, it provides a compelling rationale for a larger prospective investigation of gamma dynamics as a moderator of outcome to varied TRD therapies which impact the balance of cortical excitation and inhibition.","conditions":["Healthy","Major Depressive Disorder","Treatment Resistant Depression"],"keywords":["depression","ketamine"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"OTHER","name":"Saline"}],"enrollment":100,"startDate":"2024-01-01","completionDate":"2026-12-31","sex":"ALL","minAge":"21 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. General\n\n   * The criteria for eligibility described here are intended to protect patient welfare where, for example, the administration of ketamine in the context of standardized research (i.e. pharmaco-EEG challenge) would be inadvisable or unsafe. An additional purpose is to decrease psychiatric co-morbidities that may affect the clinical phenomenology or treatment response and thus obscure findings. Further, by virtue of the eligibility criteria the investigators seek to limit variability due to demographic and other factors.\n2. All subjects Inclusion Criteria:\n\n   * Male or Female ages 21-45, inclusive.\n   * Level of understanding sufficient to agree to all tests and examinations required by the protocol.\n3. TRD patients\n\n   * Major depressive disorder (MDD) diagnosis confirmed by MINI, with major depressive episode of at least 4 weeks duration.\n   * MADRS score of 27 or greater.\n   * Meet criteria for treatment resistance, defined as 2+ unsuccessful trials of antidepressants at an adequate dose for at least 6 weeks.\n   * On a stable dose of all psychotropic medications (including antidepressant, antipsychotic, lithium, hypnotic, etc) for a minimum of 4 weeks prior to the Screening period.\n4. MDD patients\n\n   * MDD diagnosis confirmed by the Mini International Neuropsychiatric Interview (MINI), with major depressive episode of at least 4 weeks duration.\n   * MADRS score of less than or equal to 12.\n   * On a stable dose of all psychotropic medications (including antidepressant, antipsychotic, lithium, hypnotic, etc) for a minimum of 4 weeks prior to the Screening period.\n\nExclusion Criteria:\n\n* History of MDD with psychotic features, bipolar disorder, schizophrenia spectrum and other psychotic disorders, currently exhibiting psychotic features, or a first-degree relative with a psychotic disorder.\n* Diagnosed with intellectual disability.\n* Current major medical problems that affect brain anatomy, neurochemistry, or function, e.g., liver insufficiency, kidney insufficiency, cardiovascular problems, (unstable Arrhythmias, Chronic Heart Failure, Myocardial Infarction (MI) cardiac pacemaker), systemic infections, cancer, active upper respiratory infections, respiratory depression and any brain disorder (seizure disorder, stroke, dementia, degenerative neurologic diseases), and head injury with loss of consciousness for any period of time.\n* Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female participants will be required to provide evidence of use of contraceptives during the course of the study.\n* Unable to understand the design and requirements of the study.\n* Unable to sign the informed consent for any reason.\n* Patients with a severe personality disorder, including risk for homicide or aggressive behavior, which in the opinion of the investigator has a major impact on the patients' current psychiatric status and would preclude safe study participation.\n* Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators.\n* Patients taking medications with known activity at the N-methyl-D-aspartate (NMDA) or α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) glutamate receptor \\[eg, riluzole, amantadine, lamotrigine, memantine, topiramate, dextromethorphan, D-cycloserine\\], or the mu-opioid receptor.\n* Previous exposure to ketamine or esketamine.\n* Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to screening.\n* Patients with no regular contact with at least one adult. Patients who are un-domiciled are excluded.\n* Body mass index (BMI) \\>=40 kg/m2.\n* Active eating disorder or cognitive deficit affecting the regulation of food intake.\n* Current or recent course of electroconvulsive therapy (ECT) (past month).\n* History of deep brain stimulation (DBS), vagal nerve stimulation (VNS) implantation, or other form of psychosurgery\n* Recently started cognitive behavioral therapy (CBT) (past month).\n* Patients taking \\>6mg/day lorazepam (benzodiazepine)-equivalents. Patients with lower and/or infrequent use of benzodiazepines will be required to discontinue their dose on the morning (noting that this is already per protocol at the partner ketamine clinic).\n* Patients taking prescription opioids. Over the counter pain medications are proscribed on infusion days.\n* Dietary supplements affecting central nervous system (CNS) function will be discontinued before the study start. This will include supplementation of glutamate, serotonin (e.g. 5-hydroxytryptophan(HTP), St. John's Wort), creatine, γ-Aminobutyric acid (GABA).\n* Patients habitually consuming legal cannabis products containing cannabidiol (CBD) or delta-8-tetrahydrocannabinol (THC).\n* The participant has a known ketamine allergy or is taking any medication that may interact with ketamine.","locations":[{"facility":"Wells Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas A&M (Houston Methodist Hospital Location)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julia Engelhardt","phone":"7136777595","email":"epmadlab@tamu.edu"},{"name":"Nicholas Murphy","phone":"713-677-7597","email":"nremurphy@tamu.edu"}],"primaryOutcomes":["Resting State Gamma Power","Auditory Steady State Response Gamma Power","Montgomery-Asberg Depression Rating Scale (MADRS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: testing Ketamine for Healthy","inPlainEnglish":"The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome. Previous research focused exclusively on KET-induced gamma band potentiation (GBP) in the context of a single infusion.","whoItsFor":["Ages 21 Years to 45 Years","All subjects who can join:","Male or Female ages 21-45, inclusive","Level of understanding sufficient to agree to all tests and examinations required by the protocol","Major depressive disorder (major depression) diagnosis confirmed by MINI, with major depressive episode of at least 4 weeks duration","MADRS score of 27 or greater","Meet criteria for treatment resistance, defined as 2+ unsuccessful trials of antidepressants at an adequate dose for at least 6 weeks","On a stable dose of all psychotropic medications (including antidepressant, antipsychotic, lithium, hypnotic, etc) for a minimum of 4 weeks prior to the Screening period"],"whoShouldSkip":["History of major depression with psychotic features, bipolar disorder, schizophrenia spectrum and other psychotic disorders, currently exhibiting psychotic features, or a first-degree relative with a psychotic disorder","Diagnosed with intellectual disability","Pregnancy or Breast-feeding. All female participants in reproductive age will undergo pregnancy tests. Female you would be required to provide evidence of use of contraceptives during the course of the study","Patients with a severe personality disorder, including risk for homicide or aggressive behavior, which in the opinion of the investigator has a major impact on the patients' current psychiatric status and would preclude safe study participation","Patients at serious and imminent risk of suicide and not suitable for an outpatient study, in the judgment of the investigators","Previous exposure to ketamine or esketamine","Patients starting hormonal treatment (e.g., estrogen) in the 3 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Saline. The registry lists allocation as randomized. The core objective of this study is to enhance the translational potential of this electroencephalogram (EEG) biomarker by using ketamine(KET)-induced gamma potentiation as a prognostic marker of 4-week treatment outcome.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 100 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.790Z"},{"nctId":"NCT06480383","title":"Study of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo as adjunctive therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.","conditions":["Generalized Anxiety Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITI-1284 10 mg"},{"type":"DRUG","name":"ITI-1284 20 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":705,"startDate":"2024-08-05","completionDate":"2027-03-16","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provide written informed consent before the initiation of any study specific procedures;\n2. Male or female patients ≥ 18 years of age;\n3. At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:\n\n   1. HAM-A Total score of ≥ 22;\n   2. HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;\n   3. CGI-S score of ≥ 4;\n4. History of inadequate response (\\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \\[ATRQ\\] for GAD) to at least 1 GAD-approved treatment (ie, one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 milligrams \\[mg\\], venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, daily for at least 6 weeks) for the treatment of ongoing GAD symptoms;\n5. Currently having an inadequate response to one of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) and agrees to continue the same dosing regimen for the duration of the study.\n\nNOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure.\n\nExclusion Criteria:\n\n1. Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:\n\n   1. Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n   2. Bipolar Disorder;\n2. MADRS total score \\> 18 at Screening or Baseline;\n3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or\n\n   1. At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit;\n   2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;\n   3. At Screening or Baseline MADRS Item 10 score ≥ 5; or\n   4. The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator.\n4. Lifetime history of failure to respond to \\> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75 mg, duloxetine 60 mg, escitalopram 10 mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks).","locations":[{"facility":"Behavioral Research Specialists LLC","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Valley Research Center","city":"Imperial","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy East","city":"Lemon Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research Inc","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NRC Research Institute","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anderson Clinical Research","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Premier Clinical Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Global Medical Institutes","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Dade Medical Research Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunshine Medical Solution","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Florida Research Inc","city":"Miami Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExeli Research LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Clinical Research Institute","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bio Behavioral Health","city":"Toms River","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SPRI Clinical Trials, LLC","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro Behavioral Clinical Research","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sooner Clinical Research","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lehigh Center for Clinical Research LLC","city":"Allentown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban Research Associates","city":"Media","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Trial Partners","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BioBehavioral Research of Austin PC","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aims Trials LLC","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Sv Dimitar Blagoevgrad","city":"Blagoevgrad","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mental Health Center Prof. Dr. Ivan Temkov","city":"Burgas","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Outpatient care-group practice for specialized psychiatric care Datamed OOD","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Mentalcare OOD","city":"Plovdiv","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mental Health Center - Rousse","city":"Rousse","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multiprofile Hospital for Active Treatment in Neurology and Psychiatry Sveti Naum","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Hera EOOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Intermedica, OOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical center - VAS OOD","city":"Targovishte","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Consulting Center Mladost - M Varna 1","city":"Varna","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Consulting Center Mladost - M Varna","city":"Varna","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mental Health Center - Vratsa EOOD","city":"Vratsa","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medipa S R O","city":"Brno","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"A Shine S R O","city":"Pilsen","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clintrial s r o","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Services Prague S R O","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Neuropsychiatricke pece","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Savon Psykiatripalvelu","city":"Kuopio","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oulu Mentalcare Oy","city":"Oulu","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Satakunnan Psykiatripalvelu Oy at Mehilainen Oy","city":"Tampere","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Przychodnia Srodmiescie SP. z o.o.","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specjalistyczna Praktyka Lekarska Piotr Zalitacz","city":"Gorlice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS","city":"Leszno","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Filip Rybakowski Specjalistyczna Praktyka Lekarska","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed","city":"Torun","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mental Health Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of Serbia 1","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Hospital Center Dr Dragisa Misovic- Dedi","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Special Neuropsychiatric Hospital Kovin","city":"Kovin","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi","city":"Novi Kneževac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Hamilton Anxiety Rating Scale (HAM-A)"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["glendale-california","imperial-california","lemon-grove-california","oceanside-california","orange-california","redlands-california","miami-florida","miami-springs-florida","tampa-florida","atlanta-georgia","ann-arbor-michigan","toms-river-new-jersey","brooklyn-new-york","north-canton-ohio","oklahoma-city-oklahoma","allentown-pennsylvania","media-pennsylvania","austin-texas","plano-texas","bellevue-washington","blagoevgrad-bulgaria","burgas-bulgaria","pleven-bulgaria","plovdiv-bulgaria","rousse-bulgaria","sofia-bulgaria","targovishte-bulgaria","varna-bulgaria","vratsa-bulgaria","brno-czechia","pilsen-czechia","prague-czechia","kuopio-finland","oulu-finland","tampere-finland","bialystok-poland","bydgoszcz-poland","gorlice-poland","leszno-poland","poznan-poland","torun-poland","belgrade-serbia","kovin-serbia","kragujevac-serbia","novi-kne-evac-serbia"],"enrichment":{"headline":"Phase 2: testing ITI-1284 10 mg for Generalized Anxiety Disorder","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) as added on top of your current treatment therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.","whoItsFor":["Male or female patients ≥ 18 years of age;","HAM-A Total score of ≥ 22;","HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;","CGI-S score of ≥ 4;","NOTE: The current GAD-approved treatment must be different from the GAD treatment identified as the historical failure"],"whoShouldSkip":["Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:","Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;","MADRS total score \\> 18 at Screening or Baseline;","In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or","At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit;","At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;","At Screening or Baseline MADRS Item 10 score ≥ 5; or"],"whatHappens":"If you join, the listed intervention(s) are ITI-1284 10 mg, ITI-1284 20 mg, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) as added on top of your current treatment therapy to GAD treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD who have an inadequate response to ongoing GAD treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 705 people at 59 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.346Z"},{"nctId":"NCT06481813","title":"Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","officialTitle":"BREATHE Cohort : Prospective, Longitudinal Biocollection in Thoracic Oncology, Including Newly Diagnosed Lung Cancer Patients","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Nantes University Hospital","sponsorClass":"OTHER","summary":"In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study).\n\nIn parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.","conditions":["Lung Cancer","Carcinoma, Non-Small-Cell Lung","Small Cell Lung Carcinoma","Metastatic Lung Cancer"],"keywords":["Real-world cohort","Lung Cancer","Biobank"],"interventions":[{"type":"OTHER","name":"Blood Sampling (2*8mL Tubes)"},{"type":"OTHER","name":"PBMC Sampling (1*8mL Tubes)"},{"type":"OTHER","name":"Paxgene Sampling"},{"type":"PROCEDURE","name":"Extended biopsies of tumor lesions"}],"enrollment":730,"startDate":"2024-12-10","completionDate":"2029-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPatients :\n\n* Adult\n* Patient newly diagnosed with NSCLC or CPC\n* Cared for at Nantes University Hospital\n* Affiliated or beneficiaries of a social security scheme or similar\n* Treated with a systemic therapy including chemotherapy and/or immunotherapy and/or targeted therapy and/or therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding).\n* Having agreed to participate in this study by signing the biocollection consent.\n\nHealthy subjects :\n\n* Adult\n* Affiliated or beneficiaries of a social security or similar scheme\n* Who have agreed to participate in this study by signing the Biocollection consent form.\n* No known infectious pathology\n* No known history of cancer\n* No known history of chronic autoimmune disease\n* No background immuno-suppressive treatment\n\nAncillary Study :\n\n-Metastatic NSCLC with a KRAS G12C mutation, receiving treatment with Sotorasib, Adagrasib, or another KRAS G12C inhibitor, either as monotherapy or in combination.\n\nExclusion Criteria:\n\nPatients :\n\n* Previous anticancer treatment for Lung cancer\n* Patients who have not consented to participate in the BREATHE collection\n* History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years\n* Inclusion in a therapeutic trial with blinded treatment\n* Patients under guardianship\n* Patients with AME.\n* Pregnant or breast-feeding women\n\nHealthy subjects :\n\n* Person under guardianship\n* Person benefiting from AME (State medical aid)\n* Pregnant or breast-feeding women\n\nAncillary Study :\n\n\\- Pregnant or breast-feeding women","locations":[{"facility":"CHU d'Angers","city":"Angers","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Nantes","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Rennes","city":"Rennes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Tours","city":"Tours","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elvire PONS-TOSTIVINT, MD PhD","phone":"02.40.16.59.30","email":"elvire.pons@chu-nantes.fr"}],"primaryOutcomes":["Overall survival"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":[],"locationSlugs":["angers-france","nantes-france","rennes-france","tours-france"],"enrichment":{"headline":"Not a traditional drug phase: Blood Sampling (2*8mL Tubes) for Lung Cancer","inPlainEnglish":"In clinical trials, patients are selected according to strict eligibility criteria (inclusion and who cannot join). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications.","whoItsFor":["Ages 18 Years to any","Patient newly diagnosed with NSCLC or CPC","Cared for at Nantes University Hospital","Affiliated or beneficiaries of a social security scheme or similar","Treated with a systemic therapy including chemotherapy and/or immunotherapy and/or targeted therapy and/or therapy as part of a clinical trial after agreement from the sponsors of the studies concerned (only in the absence of blinding)","Having agreed to participate in this study by signing the biocollection consent","Affiliated or beneficiaries of a social security or similar scheme","Who have agreed to participate in this study by signing the Biocollection consent form"],"whoShouldSkip":["Previous anticancer treatment for Lung cancer","Patients who have not consented to participate in the BREATHE collection","History of cancer (excluding thoracic cancer) with evidence of disease for less than 2 years","Inclusion in a therapeutic trial with blinded treatment","Patients under guardianship","Pregnant or breast-feeding women","Person under guardianship"],"whatHappens":"If you join, the listed intervention(s) are Blood Sampling (2*8mL Tubes), PBMC Sampling (1*8mL Tubes), or Paxgene Sampling. The registry lists allocation as randomized. In clinical trials, patients are selected according to strict eligibility criteria (inclusion and who cannot join).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 730 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.968Z"},{"nctId":"NCT06483074","title":"Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients","officialTitle":"Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients: a Pilot Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate.\n\nThe purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.","conditions":["End Stage Renal Disease on Dialysis","Peritoneal Dialysis Complication","Sodium-glucose Cotransporter-2 Inhibitor","Residual Kidney Function"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"}],"enrollment":48,"startDate":"2024-07-29","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Incident PD patients within 90 days of Tenckhoff catheter insertion\n2. Age 18-75 years old\n3. Patient with or without history of Type 2 diabetes\n4. Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \\> 2ml/min/1.73m2 AND urine volume \\> 400ml per day\n5. Patients who are willing to provide written informed consent\n\nExclusion Criteria:\n\n1. Patients with history of hemodialysis (≥ 3 months) or renal transplant\n2. Life expectancy \\<6 months\n3. Prior use of any type of SGLT2 inhibitors within 1 month before screening visit\n4. Poorly controlled diabetes with HBA1c \\>11%\n5. Type 1 diabetes\n6. History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)\n7. Peritonitis within 4 weeks\n8. Ketoacidosis within 5 years\n9. Known hypersensitivity to empagliflozin or other SGLT2 inhibitors\n10. Any active acute or chronic physical or mental conditions that, in the opinion of the investigator, might interfere with the compliance of participants to or the performance of this study\n11. Participation in any clinical trial or use of any investigational medicinal product 1 month before screening visit","locations":[{"facility":"Chinese University of Hong Kong","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jack KC Ng, FRCP","phone":"+852 37636098","email":"jackng@cuhk.edu.hk"},{"name":"Phyllis Cheng, BN","phone":"+852 35053528","email":"pcheng809@yahoo.com.hk"}],"primaryOutcomes":["Recruitment rate","Medication adherence","Retention rate"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":["empagliflozin"],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Phase 2: testing Empagliflozin 10 MG for End Stage Renal Disease on Dialysis","inPlainEnglish":"Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients.","whoItsFor":["Ages 18 Years to 75 Years","Incident PD patients within 90 days of Tenckhoff catheter insertion","Age 18-75 years old","Patient with or without history of Type 2 diabetes","Residual GFR (defined as the average of 24-hour urinary urea and creatinine clearances) \\> 2ml/min/1.73m2 AND urine volume \\> 400ml per day"],"whoShouldSkip":["Patients with history of hemodialysis (≥ 3 months) or renal transplant","Life expectancy \\<6 months","Prior use of any type of SGLT2 inhibitors within 1 month before screening visit","Poorly controlled diabetes with HBA1c \\>11%","History of any active malignancy within 5 years (except curatively resected basal cell or squamous cell skin cancers)","Peritonitis within 4 weeks","Ketoacidosis within 5 years"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG. The registry lists allocation as randomized. Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 48 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.615Z"},{"nctId":"NCT06486454","title":"Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)","officialTitle":"Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"HistoSonics, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this observational study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure. Sub-studies to the BOOMBOX: Master Study will investigate specific populations and/or clinical questions with more stringent enrollment criteria, standardized testing criteria, and/or follow-up schedule. Any participant enrolled in the BOOMBOX: Master Study that also qualifies for a sub-study may enroll in the sub-study in parallel; sub-studies will be described in separate sub-study protocols. The BOOMBOX: Master Study will collect information about participants before, during, and after the histotripsy treatment procedure. All participants will be followed per standard clinical follow-up based on each site's clinical practice for up to 5 years after the initial histotripsy procedure or until completion of their follow-up in a sub-study, whichever is longer.","conditions":["Liver Neoplasms","Primary Liver Cancer","Secondary Liver Cancer","Tumor Liver","Benign Liver Tumor"],"keywords":["histotripsy"],"interventions":[{"type":"DEVICE","name":"HistoSonics Edison System"}],"enrollment":5000,"startDate":"2024-10-14","completionDate":"2034-11","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject is ≥22 years of age\n2. Subject has signed the Ethics Committee (EC), or Institutional Review Board (IRB) approved study Informed Consent Form (ICF) prior to any study related tests/procedures and is willing to comply with study procedures and required follow-up assessments\n3. Subject's liver tumor(s) can be partially or completely treated with histotripsy\n\nExclusion Criteria:\n\n1. Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period\n2. Subject is enrolled in an interventional HistoSonics-sponsored trial\n3. Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol","locations":[{"facility":"University of South Alabama","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence St. Jude","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Hospital","city":"Mission Viejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Bay Hospitals","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint John's Health Center","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Altamonte Springs","city":"Altamonte Springs","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"AdventHealth Celebration","city":"Celebration","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lee Health Cancer Institute","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Miami Cardiac & Vascular Institute","city":"Miami","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Northeast Georgia Medical Center","city":"Gainesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"RUSH University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Willis Knighton Health","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass General Brigham","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Health - West","city":"Wyoming","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Valley Hospital South","city":"Centerville","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lehigh Valley Hospital","city":"Allentown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. David's Medical Center","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henrico Doctors' Hospital","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle Biedenfeld","phone":"605-354-1448","email":"Michelle.Biedenfeld@histosonics.com"},{"name":"Christine Frederiksen","phone":"307-262-7118","email":"christine.frederiksen@histosonics.com"}],"primaryOutcomes":["Histotripsy Technical Success"],"hasResults":false,"conditionSlugs":["liver-cancer","als"],"drugSlugs":[],"locationSlugs":["mobile-alabama","fullerton-california","los-angeles-california","mission-viejo-california","newport-beach-california","san-francisco-california","santa-monica-california","altamonte-springs-florida","celebration-florida","fort-myers-florida","miami-florida","gainesville-georgia","chicago-illinois","shreveport-louisiana","baltimore-maryland","boston-massachusetts","detroit-michigan","wyoming-michigan","reno-nevada","manhasset-new-york","new-york-new-york","rochester-new-york","winston-salem-north-carolina","centerville-ohio","cleveland-ohio","columbus-ohio","allentown-pennsylvania","austin-texas","richmond-virginia","seattle-washington","madison-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: HistoSonics Edison System for Liver Neoplasms","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to collect information on the use of the HistoSonics Edison System for the treatment of liver tumors. The main aim is to understand how different patient characteristics and procedural characteristics may affect histotripsy success at 36 hours post-histotripsy procedure.","whoItsFor":["Ages 22 Years to any","Subject is ≥22 years of age","Subject's liver tumor(s) can be partially or completely treated with histotripsy"],"whoShouldSkip":["Subject is pregnant or planning to become pregnant or nursing (lactating) during the study period","Subject is enrolled in an treatment HistoSonics-sponsored trial","Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at 35 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.623Z"},{"nctId":"NCT06486779","title":"Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study","officialTitle":"A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)","conditions":["Relapsing Multiple Sclerosis (RMS)"],"keywords":["Relapsing Multiple Sclerosis (RMS)","RMS","NIS","Greece","Ofatumumab","Kesimpta"],"interventions":[{"type":"OTHER","name":"Ofatumumab"}],"enrollment":160,"startDate":"2024-12-10","completionDate":"2028-12-30","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written IC must be obtained before participating in the study.\n2. Patients with diagnosis of RMS per McDonald Criteria (2017) and \\<5 years since first MS symptom prior to initiation of ofatumumab.\n3. Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.\n4. Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).\n5. Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.\n\n   Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.\n6. Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.\n\nExclusion Criteria:\n\n1. Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n2. Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.","locations":[{"facility":"Novartis Investigative Site","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Athens","state":"GR","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Alexandroupoli","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Chaïdári","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Crete Heraklion","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ioannina","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Larissa","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Pátrai","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Proportion of patients with no evidence of disease activity (NEDA-3) compared to SoC arm of STHENOS"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["athens-greece","alexandroupoli-greece","cha-d-ri-greece","crete-heraklion-greece","ioannina-greece","larissa-greece","p-trai-greece","thessaloniki-greece"],"enrichment":{"headline":"Not a traditional drug phase: Ofatumumab for Relapsing Multiple Sclerosis (RMS)","inPlainEnglish":"This study is a single-country, non-treatment, multicenter, watch-and-measure (no experimental treatment required) study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)","whoItsFor":["Ages 18 Years to 55 Years","Written IC must be obtained before participating in the study","Patients with diagnosis of RMS per McDonald Criteria (2017) and \\<5 years since first MS symptom prior to initiation of ofatumumab","Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study","Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features)","Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study"],"whoShouldSkip":["Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 160 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.273Z"},{"nctId":"NCT06486883","title":"Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype","officialTitle":"A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"MedSIR","sponsorClass":"OTHER","summary":"This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET). The main purpose of the study is to analyze the efficacy of T-DXd in patients who have HR-positive and HER2-low/ultralow advanced breast cancer classified as non-luminal subtype.","conditions":["Advanced Breast Cancer","Advanced Breast Carcinoma","Hormone Receptor Positive Breast Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Trastuzumab deruxtecan (T-DXd, DS-8201a)"},{"type":"DRUG","name":"CDK4/6i plus ET"}],"enrollment":200,"startDate":"2025-06-30","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male patients ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0-1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Evidence of HER2-low expression (1+ by immunohistochemistry (IHC) or 2+ and negative by an in situ hybridization \\[ISH\\] test) or HER2-ultralow (IHC 0 with faint membrane staining and in ≤ 10% of tumor cells) breast cancer according to the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines determined by a MEDSIR's designated central laboratory, using Ventana 4B5 antibody. This assessment has to be done on the most recently available (archived or newly collected) formalin-fixed, paraffin-embedded (FFPE) tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion, excluding bone metastases.\n6. Non-luminal breast cancer subtype as per central PAM50 analysis determined in the most recently available (archived or newly collected) FFPE tumor tissue blocks (≤ 6 weeks or FFPE of a tumor sample obtained after last prior systemic therapy) from core or excisional biopsy from a locally recurrent (breast or locoregional lymph nodes) or metastatic tumor lesion with the exception of bone metastases.\n7. Patients must have HR-positive (estrogen receptor \\[ER\\] and/or progesterone receptor \\[PgR\\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO/CAP guidelines locally determined prior to study entry.\n8. Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent.\n9. Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \\> 10 mm are eligible.\n10. Patients must have endocrine resistance criteria:\n\n    • disease progression during adjuvant ET or within the first year of completing adjuvant ET;\n\n    or endocrine sensitivity criteria:\n\n    • de novo metastatic disease or disease progression ≥ 12 months after completing adjuvant ET with at least one of the following requirements:\n    * Estrogen receptor ≤ 50% positive stained cells;\n    * and/or high histological grade or Ki67 \\> 50% on primary tumor;\n    * and/or liver metastases;\n    * and/or known non-luminal subtype as per local PAM50 analysis.\n11. No prior treatment with any systemic therapy for advanced disease.\n12. Patients treated with a CDK4/6i in the adjuvant setting with a treatment-free interval (TFI) ≥ 12 months following CDK4/6i treatment completion are eligible.\n13. Patients have adequate bone marrow, liver, and renal function:\n\n    * Hematological (without platelet, red blood cell transfusion, and/or granulocyte colony-stimulating factor support within 14 days before first study treatment dose): White blood cell (WBC) count \\> 3.0 x 109/L, absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥ 100.0 x 109/L, and hemoglobin ≥ 9.0 g/dL (≥ 5.6mmol/L).\n    * Hepatic: Serum albumin ≥ 2.5 g/dL; total bilirubin ≤ 1.5 times upper limit of normal (x ULN) (≤ 3 x ULN in patients with liver metastases or know history of Gilbert's disease); alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver/or bone metastases); aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN (≤ 5 x ULN in patients with liver metastases).\n    * Renal: Creatinine clearance ≥ 30 mL/min as determined by Cockcroft Gault (using actual body weight).\n    * Coagulation: International normalized ratio or prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN.\n14. Resolution of all acute toxic effects of prior anti-cancer therapy to Grade ≤ 1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v.5.0) (except for alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n15. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until 7 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4/6i plus ET. Female patients must refrain from egg cell donation and breastfeeding during this same period.\n16. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until 4 months after the last dose of T-DXd, or within the time period specified per local prescribing guidelines after the final dose of physician's choice of CDK4/6i plus ET. Male participants must not donate or bank sperm during this same period.\n17. Patients must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Current participation in another therapeutic clinical trial, except other translational studies.\n2. Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug.\n3. Treatment with chloroquine/hydroxychloroquine within 14 days prior to initiation of study drug.\n4. Have previously been treated with T-DXd and/or fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible.\n\n   Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample.\n5. Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \\[pleural, pericardial, and/or peritoneal\\] and pulmonary lymphangitis).\n6. Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of CDK4/6i, such as history of GI surgery which may result in intestinal blind loops and patients with clinically significant gastroparesis, short bowel syndrome, unresolved nausea, vomiting, active inflammatory bowel disease, or diarrhea of CTCAE Grade \\> 1.\n7. Known central nervous system (CNS) involvement (brain metastases and/or leptomeningeal carcinomatosis). Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n8. Have a concurrent malignancy or malignancy within 5 years of study enrollment with the exception of carcinoma in situ of the cervix and basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n9. Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients.\n10. Palliative radiotherapy with a limited field of radiation within 2 weeks or with wide field of radiation or to more than 30% of the bone marrow within 4 weeks prior to start of study treatment.\n11. Major surgical procedure or significant traumatic injury within 4 weeks before the first dose of study treatment or anticipation of need for major surgery within the course of the study treatment.\n12. Has an active cardiac disease or a history of cardiac dysfunction or conduction abnormalities including, but not confined, to any of the following:\n\n    * Participants with a medical history of myocardial infarction within 6 months before screening, symptomatic congestive heart failure (NYHA Class II to IV), unstable angina pectoris, or a recent (\\< 6 months) cardiovascular event including stroke. Participants with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation to rule out myocardial infarction.\n    * Left ventricular ejection fraction (LVEF) \\< 55% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO).\n    * History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia), which is symptomatic or requires treatment (NCI-CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication or arrhythmias controlled by pacemakers will be permitted to enroll.\n    * QT interval corrected by Fridericia's formula (QTcF) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG).\n    * History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.\n    * Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.\n13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, post COVID-19 pulmonary fibrosis, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy (complete).\n14. Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n15. Pregnant or lactating women or patients not willing to apply highly effective contraception as defined in the protocol.\n16. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test), and \\> 6 months off anti-viral treatment are eligible. Those participants should be closely monitored for HBV reactivation and have access to a local hepatitis B expert during and after the study.\n17. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n18. Patients with HCV co-infection or history of HCV co-infection.\n19. Patients with cirrhosis or fibrosis on prior imaging or biopsy.\n20. Has an active primary immunodeficiency or known human immunodeficiency virus (HIV) infection.\n21. Other active uncontrolled infection at the time of enrollment.\n22. Receipt of live or attenuated vaccine within 30 days prior to the first dose of study treatment.\n23. A history of uncontrolled seizures, CNS disorders, or serious and/or unstable pre-existing psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs or interfering with subject safety.\n24. Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers (for examples, see the Prohibited Medications Section).\n25. Known substance abuse or any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation.\n26. Inability or unwillingness to comply with the requirements of the protocol in the opinion of the investigator.","locations":[{"facility":"Medizinische Universität Graz","city":"Graz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kepler Universitäts Klinikum","city":"Linz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of Vienna","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Algemeen Ziekenhuis Klina","city":"Brasschaat","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ghent University Hospital","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Helora - Hopital de Mons","city":"Mons","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques universitaires Saint-Luc","city":"Woluwe-Saint-Lambert","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Francois Baclesse","city":"Caen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Lyon Sud","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute Paoli Calmettes","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Saint Etienne","city":"Saint-Priest-en-Jarez","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"MVZ Klinikum Aschaffenburg","city":"Aschaffenburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hämatologie-Onkologie im Zentrum MVZ","city":"Augsburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Carl Gustav Carus Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kliniken Essen Mitte","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Worms - Frauenklinik","city":"Worms","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O.U. 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Lleida","city":"Lleida","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Beata María Ana","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Doce de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Gregorio Marañón","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Santiago (CHUS)","city":"Santiago de Compostela","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Valenciano de Oncología (IVO)","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari i Politècnic La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Arnau de Vilanova de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico Universitario Lozano Blesa","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital QuirónSalud Zaragoza","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal United Hospitals Bath NHS Foundation Trust","city":"Bath","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Lancaster","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"MEDSIR","phone":"+ 34 932 214 135","email":"contact.trials@medsir.org"}],"primaryOutcomes":["Progression-free survival (PFS)","Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["graz-austria","linz-austria","vienna-austria","brasschaat-belgium","ghent-belgium","mons-belgium","woluwe-saint-lambert-belgium","caen-france","lyon-france","marseille-france","paris-france","saint-priest-en-jarez-france","aschaffenburg-germany","augsburg-germany","dresden-germany","essen-germany","worms-germany","ancona-italy","aviano-italy","florence-italy","genova-italy","milan-italy","modena-italy","monza-italy","naples-italy","negrar-italy","novara-italy","padova-italy","piacenza-italy","province-of-macerata-italy","roma-italy","amsterdam-netherlands","krakow-poland","legionowo-poland","lordelo-portugal","alcabideche-portugal","amadora-portugal","aveiro-portugal","braga-portugal","lisbon-portugal","loures-portugal","porto-portugal","barcelona-spain","c-ceres-spain","girona-spain","granada-spain","ja-n-spain","madrid-spain","majadahonda-spain","murcia-spain","reus-spain","valencia-spain","a-coru-a-spain","alicante-spain","badalona-spain","bilbao-spain","lleida-spain","m-laga-spain","santiago-de-compostela-spain","seville-spain","zaragoza-spain","bath-united-kingdom","lancaster-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Trastuzumab deruxtecan (T-DXd, DS-8201a) for Advanced Breast Cancer","inPlainEnglish":"This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET).","whoItsFor":["Ages 18 Years to any","Female or male patients ≥ 18 years of age at the time of signing ICF","how well you can do daily activities (ECOG score) of 0-1","Minimum life expectancy of ≥ 12 weeks at screening","Patients must have HR-positive (estrogen receptor \\[ER\\] and/or progesterone receptor \\[PgR\\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO/CAP guidelines locally determined prior to study entry","Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent","Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \\> 10 mm are eligible","Patients must have endocrine resistance criteria:"],"whoShouldSkip":["Current participation in another therapeutic clinical trial, except other translational studies","Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug","Treatment with chloroquine/hydroxychloroquine within 14 days prior to initiation of study drug","Have previously been treated with T-DXd and/or fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible","Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample","Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \\[pleural, pericardial, and/or peritoneal\\] and pulmonary lymphangitis)","Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab deruxtecan (T-DXd, DS-8201a), or CDK4/6i plus ET. The registry lists allocation as randomized. This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at 79 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.730Z"},{"nctId":"NCT06487221","title":"Avutometinib and Defactinib in Diffuse Gastric Cancer","officialTitle":"A Phase II Trial of Avutometinib in Combination With Defactinib in Metastatic Diffuse Gastric Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Ryan H. Moy, MD, PhD","sponsorClass":"OTHER","summary":"The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.","conditions":["Gastric Cancer","Stomach Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Avutometinib"},{"type":"DRUG","name":"Defactinib"}],"enrollment":27,"startDate":"2024-10-28","completionDate":"2028-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Histologic or cytologic evidence of gastric/gastroesophageal junction carcinoma, classified as diffuse type, poorly cohesive, signet ring cell, or mixed type. Patients with known pathogenic CDH1 and/or RHOA mutations will be allowed regardless of histology.\n2. Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine.\n3. ECOG performance status of 0 or 1\n4. Age ≥ 18 years\n5. Adequate organ function, defined by the following laboratory parameters:\n\n   a. Adequate hematologic function, including hemoglobin \\[Hb\\] ≥ 9.0 g/dL; platelets ≥ 100,000/mm3; and absolute neutrophil count \\[ANC\\] ≥ 1500/mm3. If a red blood cell transfusion or erythropoiesis-stimulating agent has been administered the Hb must remain stable and ≥ 9 g/dL for at least 1 week prior to first dose of study intervention.\n\n   (i) Subjects with Hgb ≥ 8.5 g/dL and \\<9.0 g/dL are eligible if there is no history of significant cardiovascular risk features as per the investigator (i.e., prior myocardial infarction) b. Adequate hepatic function: (i) total bilirubin ≤ 1.5 × upper limit of normal \\[ULN\\] for the institution; patients with Gilbert syndrome may enroll if total bilirubin is \\< 3.0 mg/dL (51 μmol/L); (ii) alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\n\n   ≤ 2.5 × ULN (or \\< 5 x ULN in patients with liver metastases). c. Adequate renal function with creatinine clearance rate of ≥ 50 mL/min, as calculated by the Cockcroft-Gault formula d. International normalized ratio (INR) ≤ 1.5 and partial thromboplastin time (PTT) ≤ 1.5 x ULN in the absence of anticoagulation or therapeutic levels in the presence of anticoagulation.\n\n   e. Albumin ≥ 3.0 g/dL (451 μmol/L). f. Creatine phosphokinase (CPK) ≤ 2.5 x ULN. g. Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan.\n6. Disease that can be evaluated radiographically, which can be measurable disease or non-measurable disease per RECIST 1.1. All radiology studies must be performed within 28 days prior to start of study-directed therapy.\n7. Tumor that is amenable to fresh biopsy, which may include malignant ascites that is amenable for paracentesis.\n8. Baseline QTc interval \\< 460 ms for females and ≤ 450 ms for males (average of triplicate readings) using Fredericia's QT correction formula. NOTE: This criterion does not apply to subjects with a right or left bundle branch block.\n9. Adequate recovery from toxicities related to prior treatments to at least Grade 1 by CTCAE v 5.0. Exceptions include alopecia and peripheral neuropathy grade ≤ 2. Subjects with other toxicities that are stable on supportive therapy may be allowed to participate with prior approval from the principal investigator.\n10. The effects of the study drugs on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (see Section 7.6 for Contraception Guidance) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after the last dose of the study drug.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Systemic anti-cancer therapy within 3 weeks of the first dose of study therapy, or within 5 half-lives of the previous drug, whichever is shorter.\n2. Patients currently receiving any other investigational agent.\n3. Subjects may not have had a history of malignancy other that esophagogastric cancer within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year overall survival \\>90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.\n4. Major surgery within 4 weeks or palliative radiotherapy within 1 week of the first dose of study therapy.\n5. Treatment with warfarin. Subjects on warfarin for DVT/PE can be converted to low- molecular-weight heparin (LMWH).\n6. History of treatment with a direct and specific inhibitor of FAK, MEK, or KRAS.\n7. Patients who had exposure to medications (with or without prescriptions), supplements, herbal remedies, or foods with potential for drug-drug interactions with avutometinib and/or defactinib within 14 days prior to the first dose of study intervention and during the course of therapy, including:\n\n   1. Strong CYP3A4 inhibitors or inducers.\n   2. Strong CYP2C9 inhibitors or inducers.\n   3. Strong P-glycoprotein (P-gp) inhibitors or inducers\n   4. Strong breast cancer resistance protein (BCRP) inhibitors or inducers\n8. Symptomatic brain metastases requiring steroids or other local interventions. Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks prior to first dose of study therapy, and are neurologically stable.\n9. Known hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection that is active and/or requires therapy. HIV patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the investigational agents.\n10. Active skin disorder that has required systemic therapy within the past 1 year.\n11. History of rhabdomyolysis.\n12. Concurrent ocular disorders including the following:\n\n    1. Patients with history of glaucoma, history of retinal vein occlusion (RVO), predisposing factors for RVO, including uncontrolled hypertension, uncontrolled diabetes.\n    2. Patients with history of retinal pathology or evidence of visible retinal pathology that is considered a risk factor for RVO, intraocular pressure \\> 21 mm Hg as measured by tonometry, or other significant ocular pathology, such as anatomical abnormalities that increase the risk for RVO.\n    3. Patients with active or chronic, visually significant corneal disorders, other active ocular conditions requiring ongoing therapy or clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy. Examples of visually significant corneal disorders include corneal degeneration, active or recurrent keratitis, and other forms of serious ocular surface inflammatory conditions. Visually significant corneal disorders do NOT include dry eyes, blepharitis, and uncomplicated corneal erosions.\n13. Concurrent congestive heart failure, prior history of class III/IV cardiac disease (New York Heart Association \\[NYHA\\]), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or severe obstructive pulmonary disease.\n14. Inability to swallow oral medications.\n15. History of hypersensitivity to any of the inactive ingredients (hydroxylpropylmethylcellulose, mannitol, magnesium stearate) of the investigational product.\n16. Female subjects who are pregnant or breastfeeding. Pregnant women are excluded from this study because the risk for teratogenic or abortifacient effects with the investigational agents is unknown. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother, breastfeeding should be discontinued if the mother is treated with the investigational agents.\n17. Any other medical condition (e.g., cardiac, gastrointestinal, pulmonary, psychiatric, neurological, genetic, etc.) that in the opinion of the investigator would place the subject at unacceptably high risk for toxicity.","locations":[{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Nurse Navigator","phone":"212-342-5162","email":"cancerclinicaltrials@cumc.columbia.edu"}],"primaryOutcomes":["Progression-free survival (PFS) Rate"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Avutometinib for Gastric Cancer","inPlainEnglish":"This study wants to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.","whoItsFor":["Ages 18 Years to any","Histologic or cytologic evidence of gastric/gastroesophageal junction carcinoma, classified as diffuse type, poorly cohesive, signet ring cell, or mixed type. Patients with known pathogenic CDH1 and/or RHOA mutations will be allowed regardless of histology","Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine","how well you can do daily activities (ECOG score) of 0 or 1","Adequate organ function, defined by the following laboratory parameters:","e. Albumin ≥ 3.0 g/dL (451 μmol/L). f. Creatine phosphokinase (CPK) ≤ 2.5 x ULN. g. Adequate cardiac function with left ventricular ejection fraction ≥ 55% by echocardiography (ECHO) or multiple-gated acquisition (MUGA) scan","Disease that can be evaluated radiographically, which can be measurable disease or non-measurable disease per RECIST 1.1. All radiology studies must be performed within 28 days prior to start of study-directed therapy","Tumor that is amenable to fresh biopsy, which may include malignant ascites that is amenable for paracentesis"],"whoShouldSkip":["Systemic anti-cancer therapy within 3 weeks of the first dose of study therapy, or within 5 half-lives of the previous drug, whichever is shorter","Patients currently receiving any other investigational agent","Major surgery within 4 weeks or palliative radiotherapy within 1 week of the first dose of study therapy","Treatment with warfarin. Subjects on warfarin for DVT/PE can be converted to low- molecular-weight heparin (LMWH)","History of treatment with a direct and specific inhibitor of FAK, MEK, or KRAS","Strong CYP3A4 inhibitors or inducers","Strong CYP2C9 inhibitors or inducers"],"whatHappens":"If you join, the listed intervention(s) are Avutometinib, or Defactinib. The registry lists allocation as na. This study wants to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 27 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.970Z"},{"nctId":"NCT06488118","title":"Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)","officialTitle":"Lung Immune Challenge Study Controlled Exposure to Inhaled Resiquimod (R848) to Study Mechanisms of Inflammation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Akhilesh Jha","sponsorClass":"OTHER","summary":"Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic. An underactive or overactive immune response can lead to ineffective resolution of inflammation after an infection, especially in people with airway diseases such as asthma. A better understanding of immune responses to infection that does not rely on cell or animal models is crucial to help develop better treatments for lung inflammation.\n\nAn established method of studying inflammation in humans is through careful and controlled exposure (or \"challenge\") with a mimic of a virus to simulate an infection in a similar manner to that of a virus, but with the advantage of not causing an infection. The investigators have already developed a well-tolerated mimic of human viral infection using a sterile substance called Resiquimod (or R848). Since it does not contain living organisms there is no possibility of being infected. This has been used previously as a nasal spray to cause a mild short-lived inflammation that mimics a mild cold. This has been used safely in a range of people of different ages including those who have asthma.\n\nThere are differences however in how the nose and lungs respond to viral infections. This is particularly true in those with airway diseases such as asthma, who have cells in the airways of their lungs that respond in a different way to inflammatory triggers (such as viruses).\n\nThe current study aims to build on previous research by developing a new approach of studying inflammation in the lungs using a small volume of Resiquimod. This will be done by gently inhaling a fine mist through a mouthpiece into the lungs. Blood and phlegm samples would then be collected to assess inflammation and how well people tolerate the procedure.","conditions":["Innate Immunity","Mucosal Immunity","Asthma","Viral Infection"],"keywords":["Asthma","Immunology","Viral infection","Airway Epithelium","Respiratory Medicine","Innate Immunity","Sputum"],"interventions":[{"type":"DRUG","name":"R848"},{"type":"DRUG","name":"Saline"}],"enrollment":36,"startDate":"2024-05-24","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female aged between 18 and 60 years.\n* Willing and able to give informed consent for participation in the study.\n* Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study.\n* Clinically acceptable laboratory measurements and ECG at enrolment.\n* Ability to expectorate sputum.\n* Optional additional swab for SARS-CoV-2 testing will be collected from participants if required by local or/and national health and safety policies at the time of sampling.\n\nFor healthy volunteers:\n\n* No clinical history of asthma\n* Normal baseline spirometry i.e. FEV1/Forced Vital Capacity (FVC) ratio z-score greater than the lower limit of normal.\n\nFor volunteers with asthma:\n\n* Physician-diagnosed mild to moderate asthma which is not poorly controlled as evidenced by an Asthma Control Questionnaire (ACQ-5) score of ≤1.5.\n* They are permitted to be on inhaled corticosteroids (ICS), long-acting beta agonist (LABA) and long-acting muscarinic antagonists (LAMA).\n* Pre-bronchodilator FEV1 ≥70% predicted.\n* Evidence of bronchial hyperreactivity as evidenced by either (i) Bronchodilator reversibility (increase FEV1 ≥12% and 200 mL); (ii) Positive methacholine challenge (PC20 \\&lt; 8mg/ml), or (iii) Positive challenge test as per current CUH policy.\n\nExclusion Criteria:\n\n* Upper respiratory tract infection in preceding 14 days.\n* Lower respiratory tract infection in preceding 28 days.\n* Female participants who are pregnant, lactating or planning pregnancy.\n* Respiratory diseases (other than asthma where specified).\n* Significant extrapulmonary medical conditions.\n* Extreme obesity (BMI \\&gt;40).\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.\n* Participants who have participated in another research study involving an investigational product in the past 12 weeks.\n* No newly prescribed courses of medication including corticosteroids in the four weeks before first study dose other than mild analgesia, vitamins, and supplements.\n* Smoking tobacco or vaping products in previous 6 months.\n* Smoking history of \\&gt;5 pack years.","locations":[{"facility":"NIHR Cambridge Clinical Research Facility","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Akhilesh Jha, MBBS; MRCP; PhD","phone":"+44 01223254642","email":"cuh.lungchallenge@nhs.net"},{"name":"Jade Joseph, BSc; MSc","phone":"+44 01223254642","email":"cuh.lungchallenge@nhs.net"}],"primaryOutcomes":["Change in Serum or Sputum CXCL10"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["cambridge-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing R848 for Innate Immunity","inPlainEnglish":"Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic. An underactive or overactive immune response can lead to ineffective resolution of inflammation after an infection, especially in people with airway diseases such as asthma.","whoItsFor":["Ages 18 Years to 60 Years","Male or female aged between 18 and 60 years","Female participants of child-bearing potential and male participants whose partner is of child-bearing potential must be willing to ensure that they or their partner use effective contraception during the study","Clinically acceptable laboratory measurements and ECG at enrolment","Ability to expectorate sputum","Optional additional swab for SARS-CoV-2 testing will be collected from participants if required by local or/and national health and safety policies at the time of sampling","For healthy volunteers:","No clinical history of asthma"],"whoShouldSkip":["Upper respiratory tract infection in preceding 14 days","Lower respiratory tract infection in preceding 28 days","Female participants who are pregnant, lactating or planning pregnancy","Respiratory diseases (other than asthma where specified)","Significant extrapulmonary medical conditions","Extreme obesity (body-mass index (BMI) \\&gt;40)","Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study"],"whatHappens":"If you join, the listed intervention(s) are R848, or Saline. The registry lists allocation as randomized. Respiratory viral infections can be a cause of significant illness, particularly in vulnerable individuals as seen in the COVID-19 pandemic.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at Cambridge. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.349Z"},{"nctId":"NCT06491615","title":"National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases","officialTitle":"National Ophthalmic Genotyping and Phenotyping Network, Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Eye Institute (NEI)","sponsorClass":"NIH","summary":"Background:\n\nThe eyeGENE (Registered Trademark) program is a research resource for inherited eye conditions which includes genotypic and phenotypic data, imaging, and a corresponding biobank of DNA samples from people with a variety of eye diseases. Since 2007 this registry has been helping researchers learn more about the genetic sources for many inherited eye diseases. These findings helped them create better treatments. Now researchers want to expand eyeGENE (Registered Trademark) to include more people for certain eye diseases.\n\nObjective: To collect information and DNA samples for the study of eye diseases.\n\n* Primary objective\n\n  --To expand the current eyeGENE (Registered Trademark) data repository with targeted participant accrual\n* Secondary objectives\n\n  * To enhance recruitment for clinical trials and investigations in inherited eye diseases\n\n    * To establish genotype-phenotype correlations for rare eye diseases\n\nEligibility:\n\nPeople of any age with certain eye diseases. These can include aniridia; Best disease; blue-cone monochromacy; corneal dystrophy; and disorders of pigmentation, such as albinism. Relatives unaffected by the eye disease of interest may also be needed.\n\nDesign:\n\nResearchers will select participants based on their diagnosis. The data may include images and test results from eye exams.\n\nParticipants will provide a sample of saliva. They will receive a kit with written instructions. They will spit in a tube and mail it to the NIH.\n\nParticipants may be asked to provide a blood sample. The blood may be drawn at the NIH or at a local clinic.\n\nThe eyeGENE (Registered Trademark) repository will offer researchers data about the participants eye conditions. The data may include pictures of their eyes, results of the genetic testing, and history of other diseases. Researchers will be able to see data such as age and gender, but they will not see names, dates of birth, or contact information.","conditions":["Inherited Ophthalmic Diseases","Hypopigmentation Disorder","Corneal Dystrophy","Blue-cone Monochromacy","Best Disease","Aniridia","Albinism"],"keywords":["eyeGENE","Genetics","Inherited"],"interventions":[],"enrollment":1000,"startDate":"2024-07-12","completionDate":"2054-06-27","sex":"ALL","minAge":"1 Day","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nThe participant must present with characteristics consistent with one of the following diagnoses:\n\n* Aniridia\n* Best disease\n* Blue-cone monochromacy\n* Corneal dystrophy\n* Other hypopigmentation disorder affecting vision (e.g., Oculocutaneous and ocular albinism, Hermansky-Pudlak syndrome, Chediak-Higashi syndrome)\n\nOR\n\nThe participant must be a direct, close relative of an affected participant.\n\nOR\n\nA participant who also participated in the eyeGENE Stage 1 protocol who may benefit from further genetic testing.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Those with impaired decision-making capability who do not have a legally-authorized representative.\n* Those unable to provide a saliva sample OR have any disease or condition that makes it unsafe for a subject to provide a suitable blood sample of at least 5 mL to yield more than 50 micrograms of DNA.\n\nAn individual who meets any of the following criteria will be excluded from participation in the optional retinal imaging:\n\n* Those with a history of epilepsy.\n* Children under the age of 18.","locations":[{"facility":"National Eye Institute (NEI)","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"eyeGene Coordinating Center","phone":"(301) 435-3032","email":"neieyegeneinfo@nih.gov"},{"name":"Brian P Brooks, M.D.","phone":"(301) 451-2238","email":"brooksb@mail.nih.gov"}],"primaryOutcomes":["To expand the current eyeGENE data repository with targeted participant accrual."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansio…","inPlainEnglish":"Background: The eyeGENE (Registered Trademark) program is a research resource for inherited eye conditions which includes genotypic and phenotypic data, imaging, and a corresponding biobank of DNA samples from people with a variety of eye diseases. Since 2007 this registry has been helping researchers learn more about the genetic sources for many inherited eye diseases.","whoItsFor":["Ages 1 Day to 120 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","The participant must present with characteristics consistent with one of the following diagnoses:","Blue-cone monochromacy","Other hypopigmentation disorder affecting vision (e.g., Oculocutaneous and ocular albinism, Hermansky-Pudlak syndrome, Chediak-Higashi syndrome)","The participant must be a direct, close relative of an affected participant","A participant who also participated in the eyeGENE Stage 1 protocol who may benefit from further genetic testing"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Those with impaired decision-making capability who do not have a legally-authorized representative","Those with a history of epilepsy","Children under the age of 18"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.138Z"},{"nctId":"NCT06498635","title":"Immunotherapy After Surgery for People Who Have No Remaining Cancer Cells After Standard Treatment for Early-Stage Non-Small Cell Lung Cancer, INSIGHT Trial","officialTitle":"Randomized Phase III Trial INcorporating Pathologic Complete ReSponse in Participants With Early StaGe Non Small Cell Lung Cancer to Optimize ImmunotHerapy in The AdjuvanT Setting (INSIGHT)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The usual approach for patients who are not in a study is to closely watch a patient's condition after surgery and to have regular visits with their doctor to watch for signs of the cancer coming back. Usually, patients do not receive further treatment unless the cancer returns. This study will help determine whether this different approach with durvalumab is better, the same, or worse than the usual approach of observation. Giving durvalumab may help patients live longer and prevent early-stage non-small cell lung cancer from coming back as compared to the usual approach.","conditions":["Lung Non-Small Cell Carcinoma","Stage II Lung Cancer AJCC v8","Stage IIIA Lung Cancer AJCC v8","Stage IIIB Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"BIOLOGICAL","name":"Durvalumab"},{"type":"OTHER","name":"Patient Observation"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":306,"startDate":"2025-04-01","completionDate":"2039-07-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)\n* Participants must have had a complete (R0) resection of NSCLC (with appropriate lymph node sampling as defined by the National Comprehensive Cancer Network \\[NCCN\\] guidelines) within 84 days (12 weeks) prior to randomization. Acceptable types of surgical resection are: lobectomy, sleeve resection, bi-lobectomy, or pneumonectomy. Wedge resection is not allowed.\n\n  * Note the NCCN guidelines: N1 and N2 node resection and mapping is a routine component of lung cancer resections. It is recommended at a minimum one N1 and three N2 stations is sampled or complete lymph node dissection. Formal ipsilateral mediastinal lymph node dissection is indicated for participants undergoing resection for N2 disease\n* Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review\n* Participants must have a PD-L1 status result (e.g. \\[\\< 1% versus \\>= 1% or unknown\\])\n* Participants must not have known EGFR mutations, or ALK gene fusion\n* Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines\n* Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study\n* Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization\n* Participants must not have medical contraindications or severe adverse events to receiving anti-PD-1 or anti-PD-L1 therapy\n* Participants must not have received post-operative radiation therapy (PORT) for NSCLC\n* Participants must not have any unresolved toxicity National Cancer Institute (NCI) CTCAE grade ≥ 2 from previous anticancer therapy with the exception of alopecia, and vitiligo. Note, participants with grade ≥2 neuropathy may be included at the discretion of the treating investigator. Note, participants with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included at the discretion of the treating investigator\n* Participant must be ≥ 18 years old at time of study entry\n* Participants must have body weight \\> 30 kg\n* Participant must have Zubrod performance status of 0-2\n* Participant must have a complete medical history and physical exam within 28 days prior to randomization\n* Hemoglobin \\> 9.0 g/dL (within 28 days prior to randomization)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3/uL (within 28 days prior to randomization)\n* Platelets ≥ 100 x 10\\^3/uL (within 28 days prior to randomization)\n* Total bilirubin ≤ 1 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior to randomization)\n* Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × institutional ULN (within 28 days prior to randomization)\n* Participants must have a calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault formula. This specimen must have been drawn and processed within 28 days prior to randomization. For creatinine clearance formula see the tools on the Clinical Research Associate (CRA) Workbench https://txwb.crab.org/TXWB/Tools.aspx\n* Participants must have fully recovered from the effects of prior surgery in the opinion of the treating investigator\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to randomization\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to randomization, if indicated\n* Participants must not have had an organ transplant\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participant must not have medical contraindications to receiving immunotherapy, including history of non-infectious pneumonitis that required steroids or active autoimmune disease that has required systemic treatment with disease modifying agents, corticosteroids or immunosuppressive drugs in the past two years. Replacement therapy (e.g. thyroxine for pre-existing hypothyroidism, insulin for type I diabetes mellitus, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Intra-articular steroid injections are allowed\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during protocol therapy and for 6 months following completion of protocol therapy with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen. Participants should not breastfeed during protocol therapy and for 6 months following completion of protocol therapy\n* Participants must not have received a live or live attenuated vaccine within 28 days prior randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever rabies, Bacillus Calmette-Guerin (BCG) and typhoid vaccine. Seasonal influenza vaccines and coronavirus disease 19 (COVID-19) vaccines are allowed, however, intranasal influenza vaccines (e.g. Flu-Mist) are live attenuated, and are not allowed\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete FACT-L, FACT-BRM, and PRO-CTCAE questionnaires forms in English, or Spanish must agree to participate in the patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","locations":[{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Veterans Affairs Loma Linda Healthcare System","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Roseville","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Downtown Commons","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Teresa-San Jose","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente San Leandro","city":"San Leandro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser San Rafael-Gallinas","city":"San Rafael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Medical Center - Santa Clara","city":"Santa Clara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Rosa","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South San Francisco","city":"South San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Torrance Memorial Physician Network - Cancer Care","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Vallejo","city":"Vallejo","state":"California","country":"United 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isconsin-rapids-wisconsin"],"enrichment":{"headline":"Phase 3: testing Durvalumab for Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","Participants must have histologically or cytological confirmed diagnosis of clinical stage II-IIIB (excluding clinical N3 disease) non-small cell lung cancer (NSCLC)","Participants must have a pathologic complete response (pCR) (no viable tumor in the resected specimen or lymph nodes), as determined by local pathology review","Participants must have a PD-L1 status result (e.g. \\[\\< 1% versus \\>= 1% or unknown\\])","Participants must not have known EGFR mutations, or ALK gene fusion","Participants must have received at least two cycles of neoadjuvant platinum-based chemotherapy and anti-PD-1 or anti-PD-L1 therapy. The neoadjuvant treatment must be Food and Drug Administration (FDA) approved and standard of care as listed in NCCN guidelines","Participants must not be planning to receive any concurrent non-protocol directed chemotherapy, immunotherapy, biologic or hormonal therapy for NSCLC treatment while receiving treatment on this study","Participants must not have received any prior systemic therapy (systemic chemotherapy, immunotherapy or investigational drug) within 28 days prior to randomization"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Durvalumab. The registry lists allocation as randomized. This phase III trial compares durvalumab to the usual approach (patient observation) after surgery for the treatment of patients with early-stage non-small cell lung cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 306 people at 284 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.579Z"},{"nctId":"NCT06499285","title":"A Study of Elritercept to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elritercept (KER-050) for the Treatment of Transfusion-Dependent Anemia in Adult Participants With Very Low-, Low-, or Intermediate-Risk Myelodysplastic Syndromes (MDS) (RENEW)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs. The study will also check on how safe elritercept is and how well it is tolerated.","conditions":["Myelodysplastic Syndromes"],"keywords":["Anemia","Elritercept","Myelodysplastic neoplasms","KER-050","MDS"],"interventions":[{"type":"DRUG","name":"Elritercept"},{"type":"DRUG","name":"Placebo"}],"enrollment":225,"startDate":"2025-05-06","completionDate":"2028-09-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information and/or protected personal data in accordance with national and local study participant data protections and privacy regulations.\n* Male or female greater than or equal to (≥)18 years of age at the time of signing informed consent.\n* Diagnosis of MDS with or without RS (as determined in an evaluable bone marrow sample, read by an independent central reader to confirm diagnosis at Screening) according to the World Health Organization 2016 classification that meets the International Prognostic Scoring System-Revised (IPSS-R) classification of very low, low, or intermediate risk disease. In cases where a local bone marrow (BM) assessment establishing an MDS diagnosis was conducted within 12 weeks prior to informed consent form (ICF) signature, the associated local BM samples and/or reports may be permitted.\n* Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:\n\n  a. LTB, defined as 4 to 7 RBC units per 16 weeks; or b. HTB, defined as ≥8 RBC units per 16 weeks; and c. For all participants: i. Only transfusion events for a pretransfusion hemoglobin (Hgb) lesser than (\\<)10 grams per deciliter (g/dL) are counted toward eligibility; ii. At least 1 transfusion event in each 8-week period and a minimum of 2 transfusion events separated by ≥7 days within the 16-week period immediately preceding randomization; and iii. No consecutive 56-day period can be RBC transfusion-free during the 16-week period immediately preceding randomization.\n* Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:\n\n  a. Refractory to prior ESA treatment: documentation of nonresponse or a response that was no longer maintained with a prior ESA-containing regimen, either as a single agent or combination (e.g., with granulocyte colony-stimulating factor \\[G-CSF\\]); ESA regimen must have been either: i. Recombinant human erythropoietin (EPO) ≥30,000 international units per week (IU/week) for ≥8 doses or equivalent; or ii. Darbepoetin alpha ≥500 micrograms (μg) every 3 weeks for ≥3 doses or ≥ 120 μg every week for ≥ 8 doses or equivalent.\n\n  b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE.\n\n  c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\\>)200 units per liter (U/L).\n* Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening.\n* Eastern Cooperative Oncology Group performance status of 0 to 2.\n* Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception.\n* In the opinion of the Investigator, the participant is able and willing to comply with the requirements of the protocol (e.g., all study procedures, return for follow-up visits).\n\nExclusion Criteria:\n\n* Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS).\n* Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate).\n* Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization.\n* Clinically significant cardiovascular disease defined as:\n\n  1. New York Heart Association heart disease class III or IV;\n  2. Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;\n  3. Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or\n  4. Uncontrolled arrhythmia, myocardial infarction, or unstable angina within 6 months before Screening.\n* Known ejection fraction \\<35%, confirmed by a local echocardiogram performed during Screening, or a previously performed echocardiogram if collected within 6 months before Screening.\n* Child-Pugh class C hepatic impairment.\n* Stroke, deep vein thrombosis, or pulmonary embolism within 6 months before Screening.\n* Any known history of acute myeloid leukemia (AML).\n* Prior history of malignancies, other than MDS, unless participant has been free of the disease (including completion of any treatment, including maintenance, for prior malignancy) for ≥ 2 years. However, participants with a history or concurrent diagnosis of the following conditions are allowed if not requiring systemic therapy:\n\n  1. Basal or squamous cell carcinoma of the skin;\n  2. Carcinoma in situ of the cervix;\n  3. Carcinoma in situ of the breast; and/or\n  4. Incidental histologic finding of prostate cancer (T1a or T1b using the tumor, node, metastasis \\[TNM\\] clinical staging system).\n  5. Early papillary thyroid cancer (stage I \\[T1-T2, N0, M0\\]).\n* History of solid organ or bone marrow transplantation.\n* Active infection requiring intravenous treatment (e.g., antibiotics, antifungals, or antivirals) within 28 days, or oral treatment within 14 days before randomization.\n* Active infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with a history of HIV infection may be enrolled if they are receiving antiretroviral therapy and have a documented CD4+ T cell count \\> 200 cells per microliter (cells/μL) at screening. Participants without known positive history of HIV, HBV, and/or HCV do not require further testing, unless testing is mandated per local guidelines.\n* Body mass index ≥ 40 kilograms per meter square (kg/m\\^2).\n* Major surgery within 28 days before randomization.\n* History of allergy/anaphylaxis to investigational medicinal product (IMP) excipients (refer to the current elritercept IB for a list of excipients) or recombinant proteins.\n* Prior use of elritercept, luspatercept, or sotatercept.\n* Prior use of hypomethylating agents (HMAs), isocitrate dehydrogenase inhibitor, lenalidomide, imetelstat, or immunosuppressive therapy given for treatment of MDS.\n* Iron chelation therapy initiated within 8 weeks before randomization. Participants on stable or decreasing doses of iron chelation therapy for ≥ 8 weeks are allowed.\n* Vitamin B12 or folate therapy initiated within 4 weeks before randomization. Participants on stable replacement doses for ≥ 4 weeks and without ongoing concurrent vitamin B12 or folate deficiency are allowed.\n* Androgen use within 8 weeks before randomization. Participants on stable androgen dosing for hypogonadism for ≥ 8 weeks are allowed.\n* High-dose systemic corticosteroid use within 4 weeks before randomization. Participants on stable chronic steroid doses of prednisone lesser than or equal to (≤) 10 milligrams per day (mg/day) or corticosteroid equivalent for ≥ 4 weeks are allowed.10 mg/day or corticosteroid equivalent for ≥ 4 weeks are allowed.\n* Treatment with any investigational drug within 28 days before Screening or, if the half-life of the product is known, within 5 times the half-life before Screening, whichever is longer.\n* Ongoing participation in another interventional clinical study.\n* Serum EPO level \\>500 U/L.\n* Platelet count ≥800 × 10\\^9 per liter (/L) or ≤25 × 10\\^9/L.\n* Absolute neutrophil count ≤ 500 per microliter (/µL).\n* Serum aspartate aminotransferase or alanine aminotransferase ≥3 × the upper limit of normal (ULN).\n* Total bilirubin ≥2 × ULN unless attributable to Gilbert's syndrome. Participants with known history of Gilbert syndrome with unconjugated bilirubin \\< 3 × ULN are allowed. Higher levels, if attributed to active RBC precursor destruction within the bone marrow (ineffective erythropoiesis), may be allowed upon medical monitor review.\n* Ferritin ≤ 50 micrograms per litre (μg/L).\n* Folate ≤2.0 nanograms per milliliter (ng/mL).\n* Vitamin B12 ≤200 picograms per milliliter (pg/mL).\n* Estimated glomerular filtration rate \\<30 milliliters per minute per 1.73 meter square (mL/min/1.73m\\^2) as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Collaboration equation.\n* Pregnant or lactating female.\n* Any other condition not specifically noted above that, in the opinion of the Investigator, would preclude the participant from participating in the study or could confound interpretation of data from the study.\n* Investigational site staff members directly involved in the conduct of the study and site staff members otherwise supervised by the Investigator, employees of the Sponsor or CRO directly involved in the conduct of the study, or immediate family members (defined as a spouse, parent, child, or sibling, whether biological or legally adopted).\n* For Participants in France: Persons under court protection, persons not affiliated with a social security system, and protected adults (per applicable French law \\[Art. L. 1121-6, Art. L. 1121-8, Art. L. 1121-8-1\\]).","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Cancer Network","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital at Yale-New Haven","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Hospital and Clinics","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ILCC. 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Hospital","city":"Huddinge","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sahlgrenska University Hospital","city":"Gothenburg","state":"VG","country":"Sweden","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Skane University Hospital - Lund, Department of Hematology and Vascular Disorders","city":"Lund","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hosptial Basel","city":"Basel","state":"Canton of Basel-City","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Insel Gruppe AG, University Clinic for Hematology and Central Hematological Laboratory","city":"Bern","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitatsspital Zurich, Klinik fur Medizinische Onkologie und Hamatologie","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital","city":"Changhua","state":"Changhua County","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Bing Show Chwan Memorial Hospital","city":"Changhua","state":"Changhua County","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linkou Chang Gung Memorial Hospital","city":"Taoyuan City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Chulalongkorn Memorial Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rajavithi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banphaeo General Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maharaj Nakorn Chiangmai Hospital","city":"Chiang Mai","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adana City Hospital","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Etlik City Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara University Medical Faculty Cebeci Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Antalya Education and Training Hospital","city":"Antalya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mersin Medicalpark Hospital","city":"Mersin","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sakarya University Medical Faculty Hospital","city":"Sakarya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ondokuz Mayis University School of Medicine, Department of Hematology","city":"Samsun","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aberdeen Royal Infirmary","city":"Aberdeen","state":"Aberdeen City","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Glan Clwyd Hospital","city":"Rhyl","state":"Denbighshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Leicester","city":"Leicester","state":"Leics","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lincolnshire Community and Hospitals NHS group","city":"Lincoln","state":"Lincolnshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Newcastle Upon Tyne University Hospitals Foundation Trust","city":"High Heaton","state":"Tyne and Wear","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Tyneside and Sunderland Foundation Trust","city":"Sunderland","state":"Tyne and Wear","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St James's University Hospital","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute (SCRI)","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nottingham City Hospital","city":"Nottingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Churchill Hospital","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Takeda Contact","phone":"+1-877-825-3327","email":"medinfoUS@takeda.com"}],"primaryOutcomes":["Percentage of Participants Achieving Transfusion Independence (TI) for ≥8 Weeks"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["duarte-california","glendale-california","la-jolla-california","new-haven-connecticut","miami-florida","tampa-florida","peoria-illinois","louisville-kentucky","monroe-louisiana","columbia-maryland","kansas-city-missouri","henderson-nevada","westbury-new-york","winston-salem-north-carolina","canton-ohio","cleveland-ohio","knoxville-tennessee","nashville-tennessee","denison-texas","houston-texas","red-oak-texas","the-woodlands-texas","webster-texas","issaquah-washington","garran-australia","sydney-australia","douglas-australia","adelaide-australia","box-hill-australia","fitzroy-australia","melbourne-australia","parkville-australia","curitiba-brazil","porto-alegre-brazil","joinville-brazil","ja-brazil","santo-andr-brazil","s-o-jos-do-rio-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","plovdiv-bulgaria","sofia-bulgaria","varna-bulgaria","edmonton-canada","vancouver-canada","halifax-canada","london-canada","toronto-canada","concepci-n-chile","la-serena-chile","santiago-chile","brno-czechia","hradec-kr-lov-czechia","ostrava-czechia","prague-czechia","nice-france","paris-france","poitiers-france","toulouse-france","bonn-germany","d-sseldorf-germany","leipzig-germany","halle-germany","magdeburg-germany","berlin-germany","budapest-hungary","debrecen-hungary","kaposv-r-hungary","ny-regyh-za-hungary","sz-kesfeh-rv-r-hungary","ahmedabad-india","ern-kulam-india","mumbai-india","new-delhi-india","ludhiana-india","vellore-india","ghaziabad-india","kolkata-india","delhi-india","g-rgaon-india","cork-ireland","dublin-ireland","limerick-ireland","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","ancona-italy","turin-italy","florence-italy","milan-italy","pavia-italy","reggio-calabria-italy","rome-italy","rozzano-italy","kaunas-lithuania","vilnius-lithuania","lima-peru","bellavista-peru","poznan-poland","wroclaw-poland","katowice-poland","lodz-poland","olsztyn-poland","cape-town-south-africa","durban-south-africa","johannesburg-south-africa","pretoria-south-africa","daegu-south-korea","seoul-south-korea","salamanca-spain","barcelona-spain","lhospitalet-de-llobregat-spain","madrid-spain","valencia-spain","rebro-sweden","huddinge-sweden","gothenburg-sweden","lund-sweden","basel-switzerland","bern-switzerland","zurich-switzerland","changhua-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","bangkok-thailand","chiang-mai-thailand","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","mersin-turkey-t-rkiye","sakarya-turkey-t-rkiye","samsun-turkey-t-rkiye","aberdeen-united-kingdom","rhyl-united-kingdom","leicester-united-kingdom","lincoln-united-kingdom","high-heaton-united-kingdom","sunderland-united-kingdom","birmingham-united-kingdom","cambridge-united-kingdom","leeds-united-kingdom","london-united-kingdom","manchester-united-kingdom","nottingham-united-kingdom","oxford-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Elritercept for Myelodysplastic Syndromes","inPlainEnglish":"The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions. Other aims are to learn how well elritercept works in reducing the need for RBC transfusions over longer periods of time or in adults with high transfusion needs.","whoItsFor":["Ages 18 Years to any","Transfusion dependence assessed in the 16 weeks immediately preceding randomization in two 8-week blocks, classified as either:","Refractory or intolerant to prior erythropoiesis-stimulating agent (ESA) treatment (discontinued ≥4 weeks before randomization), or unlikely to respond to ESA treatment, defined as follows:","b. Intolerant to prior ESA treatment: documentation of discontinuation of a prior ESA-containing regimen, either as a single agent or combination (e.g., with G-CSF), at any time after introduction due to intolerance or an AE","c. Unlikely to respond to ESA treatment: low chance of response to ESA based on an endogenous serum EPO level greater than (\\>)200 units per liter (U/L)","Less than 5 percent (%) blasts in an evaluable bone marrow sample collected at Screening","Eastern Cooperative Oncology Group performance status of 0 to 2","Females of childbearing potential and sexually active males must agree to use highly effective methods of contraception"],"whoShouldSkip":["Del(5q) MDS, secondary MDS (MDS with a documented history of prior exposure to chemotherapy, radiotherapy, or other leukemogenic agents that is considered causally related to the development of MDS)","Anemia due to any other known cause (e.g., thalassemia, hemolytic anemia, bleeding events, or deficiency of iron, B12, and/or folate)","Receipt of RBC transfusion for any reason(s) other than underlying MDS within 16 weeks before randomization","Clinically significant cardiovascular disease defined as:","New York Heart Association heart disease class III or IV;","Fridericia corrected QT (QTcF) interval \\>500 milliseconds during Screening;","Presence of uncontrolled hypertension defined as mean systolic blood pressure ≥160 millimeters of mercury (mm Hg) or diastolic blood pressure ≥100 mm Hg during Screening; or"],"whatHappens":"If you join, the listed intervention(s) are Elritercept, or Placebo. The registry lists allocation as randomized. The main aim of this study is to find out how well elritercept works in lowering the need for RBC transfusions.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 225 people at 182 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.447Z"},{"nctId":"NCT06501781","title":"Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)","officialTitle":"Peer Behavioral Activation Utilization to Improve Substance Use and HIV Outcomes in People Receiving Long Acting Injectable-PrEP/ART (PUSH)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Maryland, Baltimore","sponsorClass":"OTHER","summary":"This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART (\"Peer Activate-LAI\") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to:\n\nAim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory)\n\nAim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.\n\nAim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives.\n\nThis study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.","conditions":["HIV Infections","Substance Use"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Peer Activate-LAI"},{"type":"OTHER","name":"Standard of Care HIV treatment or prevention with LAI-PrEP/ART"}],"enrollment":186,"startDate":"2025-03-18","completionDate":"2028-12-30","sex":"ALL","minAge":"18 Years","maxAge":"88 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Able and willing to sign informed consent\n* HIV status:\n\nHIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test\n\n* Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information\n* Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol\n\nExclusion Criteria:\n\n* Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation\n* Pregnant or breastfeeding","locations":[{"facility":"HIPS (Harm reduction drop-in center)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baltimore Safe Haven","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elana Rosenthal, MD","phone":"240-367-4157","email":"erosenthal@ihv.umaryland.edu"},{"name":"Emade Ebah Edongole, RN","phone":"202-655-6229","email":"eebah@ihv.umaryland.edu"}],"primaryOutcomes":["LAI-PrEP/ART Complete Adherence"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Peer Activate-LAI for HIV Infections","inPlainEnglish":"This randomly assigned Type 1 hybrid effectiveness-implementation trial (N=186) will measure the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART (\"Peer Activate-LAI\") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to: Aim 1: measure the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory) Aim 2: To measure the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.","whoItsFor":["Ages 18 Years to 88 Years","Age 18 years or older","HIV negative with a negative HIV antibody/antigen test and meeting CDC(center for disease control and prevention) criteria for PrEP HIV positive with a positive antibody/antigen test","Meeting indications for treatment based on Cabotegravir-LA (HIV negative) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV positive) prescribing information","Moderate substance use, defined as a (World Health Organization Alcohol, Smoking and Substance Involvement Screening Test) WHO-ASSIST score of ≥4 for certain drugs (cocaine, amphetamines, inhalants, sedatives, hallucinogens, or opioids) or ≥11 for alcohol"],"whoShouldSkip":["Contraindications to Cabotegravir-LA (HIV-) or Cabotegravir (CAB) and Rilpivirine (RPV)-LA (HIV+) use based on prescribing information or other medical/psychiatric conditions that may interfere with study participation","Pregnant or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Peer Activate-LAI, or Standard of Care HIV treatment or prevention with LAI-PrEP/ART. The registry lists allocation as randomized. This randomly assigned Type 1 hybrid effectiveness-implementation trial (N=186) will measure the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART (\"Peer Activate-LAI\") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 186 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.530Z"},{"nctId":"NCT06501807","title":"BIOlogics in Severe Nasal POlyposis SurvEy.: a French Registry","officialTitle":"Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Lille","sponsorClass":"OTHER","summary":"With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.\n\nDuring the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.\n\nNew biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.\n\nHerein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).","conditions":["Rhinosinusitis Chronic","Nasal Polyps"],"keywords":["nasal polyp","chronic rhinosinusitis","eosinophil","endotype"],"interventions":[{"type":"DRUG","name":"Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval)."}],"enrollment":900,"startDate":"2024-07-11","completionDate":"2034-09-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval.\n* The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected\n\nExclusion Criteria:\n\n* Oral corticotherapy in the previous month;\n* Biologic treatment with anti-IgE (omalizumab), anti-IL-5/IL-5R (mepolizumab, benralizumab) or anti-IL-4/IL-13R (dupilumab) or any other biotherapy for inflammatory diseases in the previous 6 months of initiation of treatment apart from ongoing biotherapies for severe asthma or CRSwNP;\n* Hypersensitivity to humanized antibodies ;\n* Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;\n* Pregnant or breast-feeding women;\n* Patient without social coverage.","locations":[{"facility":"CHU de Lille","city":"Lille","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"chu de Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Geoffrey Mortuaire, MD, pHD","phone":"0320445675","email":"geoffrey.mortuaire@chru-lille.fr"},{"name":"Geoffrey Mortuaire","phone":"0320445675","email":"geoffrey.mortuaire@chru-lille.fr"}],"primaryOutcomes":["Comparison of quality of life over 5 years according to the asthmatic status of the patients"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["dupilumab"],"locationSlugs":["lille-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval). for Rhinosinusitis Chronic","inPlainEnglish":"With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.","whoItsFor":["Ages 18 Years to any","Patients of over 18-year old requiring a biologic treatment for CRswNP in accordance with its marketing approval","The patients already treated according to this criteria since August 2021 will be followed and their previous clinical and biological data retrospectively collected"],"whoShouldSkip":["Oral corticotherapy in the previous month;","Hypersensitivity to humanized antibodies ;","Documented SARS-Cov2 infection in the last 3 months with persistent olfactory disorders related to COVID;","Pregnant or breast-feeding women;","Patient without social coverage"],"whatHappens":"If you join, the listed intervention(s) are Biologic treatments available in Chronic Rhinosinusitis with Nasal Polyps (dupilumab, mepolizumab and benralizumab according to their marketing approval).. The registry lists allocation as na. With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 900 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.715Z"},{"nctId":"NCT06502548","title":"Endometriosis Transcriptomic Cell Atlas","officialTitle":"Establishing an Endometriosis Transcriptomic Cell Atlas to Decipher the Pathophysiological Role of Stem Cells and Estrogens in the Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Toulouse","sponsorClass":"OTHER","summary":"Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment. The most widely accepted hypothesis to explain the formation of endometriotic lesions is the tubal retrograde reflux during menstruation. However, only 10% of the reproductive age women will develop endometriosis while 90% of women experience retrograde menstruation. This raises the question of the stem cells present in the endometrium and menstrual reflux of these patients, but also of both the peritoneal microenvironment and the estrogenic local signaling which allow the implantation of these lesions.","conditions":["Endometriosis","Infertility"],"keywords":["Stem cells","Organoid","Estrogen Receptor ERα","immune cells","single cell transcriptomic"],"interventions":[{"type":"PROCEDURE","name":"Endometriosis"},{"type":"PROCEDURE","name":"Tubal ligation or Hysterectomy"}],"enrollment":92,"startDate":"2024-09-27","completionDate":"2027-09","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients over 18 and under 45 years of age\n* Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility.\n* Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation\n* Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis\n* Patients operated on strictly at the time of menstruation\n* Participants who have not been on hormonal treatment for 2 months\n* Participant having signed the free and informed consent form\n* Membership of a Social Security scheme or equivalent\n\nExclusion Criteria:\n\n* Patients with endometriosis non-surgically treated\n* Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery\n* Patients with adenomyosis only\n* Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes\n* Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)\n* Patients with positive serology for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B (HBV) and hepatitis C (HCV)","locations":[{"facility":"University Hospital Toulouse","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elodie CHANTALAT, MD","phone":"0561323953","email":"chantalat.e@chu-toulouse.fr"},{"name":"Françoise LENFANT, PhD","phone":"","email":"francoise.lenfant@inserm.fr"}],"primaryOutcomes":["Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the endometrium of healthy control patients","Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in the peritoneal fluid of healthy control patients","Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometriosis lesions for endometriosis patients.","Analyze of the number of the different cell types (immune cells and endometrial stem cells) present in endometrium of endometriosis patients."],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["toulouse-france"],"enrichment":{"headline":"Not a traditional drug phase: Endometriosis for Endometriosis","inPlainEnglish":"Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years. A better understanding of the initiation phase is a major challenge to improve diagnosis and treatment.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Patients over 18 and under 45 years of age","Patients with multiple endometriosis sites (superficial, deep and endometriomas) with an indication for surgery to treat disabling painful symptoms and stage III or IV endometriosis in the context of infertility","Healthy patients including those operated on between the ages of 18 and 45 for tubal ligation","Healthy patients operated on between the ages of 18 and 45 for hysterectomies for benign causes other than endometriosis or adenomyosis","Patients operated on strictly at the time of menstruation","Participants who have not been on hormonal treatment for 2 months","Membership of a Social Security scheme or equivalent"],"whoShouldSkip":["Patients with endometriosis non-surgically treated","Patients with endometriosis receiving hormonal treatment at the time of surgery or having received hormonal treatment in the 2 months prior to surgery","Patients with adenomyosis only","Healthy non-endometriotic patients undergoing hysterectomy for infectious or malignant causes","Patients benefiting from a legal protection measure (guardianship, curatorship, safeguard of justice)","Patients with positive serology for human immunodeficiency virus (HIV), human T-lymphotropic virus (HTLV), hepatitis B (HBV) and hepatitis C (HCV)"],"whatHappens":"If you join, the listed intervention(s) are Endometriosis, or Tubal ligation or Hysterectomy. The registry lists allocation as randomized. Endometriosis is an estrogen-dependent, chronic inflammatory gynecologic disease affecting women of reproductive age, with a therapeutic wandering of 6 to 10 years.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 92 people at Toulouse. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.107Z"},{"nctId":"NCT06503146","title":"18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection","officialTitle":"18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nFibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \\[18F\\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan. Researchers believe that \\[18F\\]FAPI-74 PET imaging may be able to visualize cancer more effectively than the approved tracers. If so, the new tracer would make it easier to find FAP-positive tumors in the body.\n\nObjective:\n\nTo see if \\[18F\\]FAPI-74 PET scan is as good or better than other imaging methods for detecting certain cancers.\n\nEligibility:\n\nPeople aged 18 years or older with one of these cancer types: pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma. Participants must be scheduled or intended to receive treatment for cancer.\n\nDesign:\n\nParticipants will have 2 baseline scans: an \\[18F\\]FAPI-74, and the approved tracer \\[18F\\]-FDG.\n\nThe \\[18F\\]FAPI-74 will be infused through a needle inserted into a vein. About 1 hour later, the participant will undergo imaging.\n\nWithin 1 week, participants will undergo the same scanning procedures with the approved tracer.\n\nIf the baseline scan with \\[18F\\]FAPI-74 shows the tumor(s), scans with this tracer will be repeated when their regular treatment regimen calls for scans again. If the scan with the regular FDG also show tumors, this scan will be repeated within the same week as the repeated \\[18F\\]FAPI-74 scan. If \\[18F\\]-FAPi PET scan shows no tumor(s), scans will not be repeated.\n\nIf the participant's cancer progresses within 2 years, scans may be repeated.\n\nFollow-up calls will continue for 2 years.","conditions":["Sarcoma","Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)","Mesothelioma","Pheochromocytoma/Paraganglioma (PPGL)","Pancreatic Ductal Adenocarcinoma","Ovarian Cancer","Hepatocellular Carcinoma","Gastric Cancer","Cholangiocarcinoma","Bladder Cancer"],"keywords":["Fluorodeoxyglucose F18","PET Imaging","18F-Fibroblast Activation Protein Inhibitor"],"interventions":[{"type":"DRUG","name":"[18F]FAPI-74"},{"type":"DRUG","name":"[18F]FDG"}],"enrollment":320,"startDate":"2025-09-09","completionDate":"2028-06-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Histologically confirmed pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, hepatocellular carcinoma (HCC), gastric cancer, bladder cancer, ovarian cancer, pheochromocytoma/paraganglioma (PPGL), small cell lung cancer (SCLC) or extrapulmonary neuroendocrine cancer (EP-NEC), mesothelioma or sarcoma.\n* Participants must be scheduled or intended to receive treatment for their cancer.\n* Evaluable disease\n* \\>= 18 years old.\n* Eastern Cooperative Oncology Group (ECOG) performance score \\<= 2.\n* Individuals of child-bearing potential (IOCBP) and individuals that can father children must agree to use effective contraception (barrier, hormonal, intrauterine device (IUD), surgical sterilization, abstinence) at the study entry and for 2 months after each (18F) FAPI-74 imaging. Sperm may not be frozen or donated within the same period.\n* Must be willing to discontinue breastfeeding for 2 months after each study imaging.\n* The ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to \\[18F\\]FAPI-74 or other agents used in the study.\n* History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes.\n* Weight \\> 350 lbs., or inability to fit within the imaging gantry.\n* Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening.\n* Uncontrolled intercurrent illness, or medical condition(s) including but not limited to renal failure, liver failure, or psychiatric illness/social situations evaluated by medical history and physical exam that would limit compliance with study requirements and potentially increase risk for the participant.\n* Serum creatinine \\> 2 times the upper limit of normal.\n* Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yolanda L McKinney, R.N.","phone":"(240) 760-6095","email":"ymckinney@mail.nih.gov"},{"name":"Esther Mena Gonzalez, M.D.","phone":"(240) 760-6111","email":"esther.menagonzalez@nih.gov"}],"primaryOutcomes":["Mean number of lesions"],"hasResults":false,"conditionSlugs":["lung-cancer","ovarian-cancer","bladder-cancer","liver-cancer","stomach-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing [18F]FAPI-74 for Sarcoma","inPlainEnglish":"Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types. \\[18F\\]FAPI-74 is a new PET (positron emission tomography) tracer, a substance that is injected into a person s body before an imaging scan.","whoItsFor":["Ages 18 Years to 120 Years","Participants must be scheduled or intended to receive treatment for their cancer","Eastern Cooperative Oncology Group (ECOG) performance score \\<= 2","Must be willing to discontinue breastfeeding for 2 months after each study imaging"],"whoShouldSkip":["History of allergic reactions attributed to compounds of similar chemical or biologic composition to \\[18F\\]FAPI-74 or other agents used in the study","History of severe claustrophobia unresponsive to oral anxiolytics or history of any other condition preventing the ability to lie on the imaging scanner for up to 45 minutes","Weight \\> 350 lbs., or inability to fit within the imaging gantry","Positive Beta-human chorionic gonadotropin (Beta-HCG) serum or urine pregnancy test performed in IOCBP at screening","Serum creatinine \\> 2 times the upper limit of normal","Liver transaminases (ALT, AST) greater than 3 times the upper limit of normal"],"whatHappens":"If you join, the listed intervention(s) are [18F]FAPI-74, or [18F]FDG. The registry lists allocation as na. Background: Fibroblast-activation protein (FAP) is an enzyme that appears in high numbers in cancer-associated fibroblasts of certain cancer types.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 320 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.629Z"},{"nctId":"NCT06503510","title":"Role of Interleukin-13 Pathways on Pain and Itch Sensitivity","officialTitle":"The Role of the Interleukin-13 Pathways on Pain and Itch Sensitivity in Patients With Atopic Dermatitis and Healthy Volunteers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Aalborg University","sponsorClass":"OTHER","summary":"Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms. Research has shown that the proteins interleukins are involved in inflammation and itch in atopic dermatitis. The medicinal product called Lebrikizumab, used for treatment of AD, has shown to block the interleukin called IL-13. The purpose of this experiment is to evaluate the role of IL-13 in itch in both healthy subjects and people with atopic dermatitis.","conditions":["Itch"],"keywords":[],"interventions":[{"type":"OTHER","name":"Histamine"},{"type":"OTHER","name":"Cowhage"},{"type":"OTHER","name":"bovine adrenal medulla (BAM8-22)"}],"enrollment":20,"startDate":"2025-01-06","completionDate":"2025-12-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Healthy men and women\n* 18-60 years\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Drug addiction defined as any use of cannabis, opioids, or other drugs\n* Previous or current history of neurological, dermatological (e.g., AD, psoriasis, etc.), immunological, musculoskeletal, cardiac disorder, or psychiatric diagnoses that may affect the results (e.g., neuropathy, muscular pain in the upper extremities, anxiety, depression, schizophrenia, etc.)\n* Moles, wounds, scars, or tattoos in the area to be treated or tested\n* Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment).\n* Use of systemic and topical corticosteroids\n* Consumption of alcohol or painkillers 24 hours before the study days and between these\n* Acute or chronic pain\n* Participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)\n* Lack of ability to cooperate","locations":[{"facility":"Aalborg University","city":"Gistrup","state":"Aalborg","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNAP","city":"Gistrup","state":"Aalborg","country":"Denmark","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Aalborg University","city":"Aalborg","state":"Denmark","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Silvia Lo Vecchio","phone":"21397785","email":"slv@hst.aau.dk"}],"primaryOutcomes":["Measuring itch by computerized Visual Analog Scale Scoring","Measuring pain by computerized Visual Analog Scale Scoring","Superficial blood perfusion","Superficial blood perfusion","Wheal reaction","Average pruritis and pain numerical rating scale (NRS)","Skin peak pain numerical rating scale (SPP-NRS)","Peak pruritus numerical rating scale (PP-NRS)","Mechanically evoked itch (MEI)","Mechanically evoked itch (MEI)"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["gistrup-denmark","aalborg-denmark"],"enrichment":{"headline":"Not a traditional drug phase: Histamine for Itch","inPlainEnglish":"Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population. Intense itch and skin pain are the main symptoms.","whoItsFor":["Ages 18 Years to 60 Years","Healthy men and women"],"whoShouldSkip":["Pregnancy or lactation","Drug addiction defined as any use of cannabis, opioids, or other drugs","Moles, wounds, scars, or tattoos in the area to be treated or tested","Current use of medications that may affect the trial such as antihistamines and pain killers (use of antihistamines should be discontinued 72 hours before the experiment and all topical agents and emollients should be discontinued 24 hours before the experiment)","Use of systemic and topical corticosteroids","Consumption of alcohol or painkillers 24 hours before the study days and between these","Acute or chronic pain"],"whatHappens":"If you join, the listed intervention(s) are Histamine, Cowhage, or bovine adrenal medulla (BAM8-22). The registry lists allocation as na. Atopic dermatitis (AD) is as chronic, inflammatory skin disorder affecting 20% of the world's population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.818Z"},{"nctId":"NCT06506461","title":"Gene Editing For Sickle Cell Disease","officialTitle":"St. Jude Autologous Genome Edited Stem Cells For Sickle Cell Disease-1","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"St. Jude Children's Research Hospital","sponsorClass":"OTHER","summary":"This study is being done to test the safety of a new treatment called gene editing in Sickle Cell Disease (SCD) patients and to see if a single dose of this genetically modified cellular product will increase the amount of a certain hemoglobin called fetal hemoglobin (HbF) and help reduce the symptoms of SCD.\n\nPrimary Objective\n\n* To assess the safety of autologous infusion of clustered regularly interspaced palindromic repeats (CRISPR)/ CRISPR associated protein (Cas9)-edited CD34+ hematopoietic stem and progenitor cells (HSPCs) in patients with severe SCD.\n\nSecondary Objective\n\n* To assess the efficacy autologous infusion of CRISPR/Cas9 genome-edited CD34+ HSPCs into patients with severe SCD.","conditions":["Sickle Cell Disease"],"keywords":["Plerixafor","Autologous","CD34+ cells","Apheresis","Conditioning","Busulfan","Gene Editing"],"interventions":[{"type":"DRUG","name":"Plerixafor"},{"type":"DRUG","name":"Busulfan"},{"type":"BIOLOGICAL","name":"Gene-modified CD34+ cells"},{"type":"DRUG","name":"Motixafortide"}],"enrollment":25,"startDate":"2025-03-21","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":"24 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years and ≤24.9 years.\n* Patients with SCD (Hb SS, Hb SB0 and Hb SB+ genotype) who have experienced EITHER (a) 2 or more SCD-related vaso-occlusive events (acute pain events, acute chest syndrome, priapism and splenic sequestration) per year in the 2-year period before screening, OR (b) administration of regular red blood cell (RBC) transfusions (≥8 transfusions in the 12 months preceding enrollment) EXCEPT if the RBC transfusions are being administered for primary or secondary stroke prevention and, in the opinion of the treating hematologist, cannot be safely discontinued after infusion of the gene modified drug product.\n* Failure, intolerance, or refusal of hydroxyurea therapy.\n* Patients must be eligible for autologous stem cell transplant as per investigator's judgment.\n* Females of childbearing potential (i.e., those who are post-menarchal with an intact uterus and at least 1 ovary, and those who are less than 1 year postmenopausal) must agree to use acceptable method(s) of contraception from start of mobilization through at least 6 months post-infusion.\n* Males must agree to use effective contraception from start of mobilization through at least 6 months post-infusion.\n* Patients should be willing to participate in an additional long-term follow-up study after completion of this trial.\n\nExclusion Criteria:\n\n* Availability of an human leukocyte antigen (HLA)-matched sibling who is willing and able to donate an appropriate graft for hematopoietic cell transplantation (HCT).\n* Karnofsky or Lansky performance score \\< 80.\n* Pregnant, as confirmed by positive serum or urine pregnancy test within 14 days before enrollment (if female).\n* Breastfeeding.\n* Uncontrolled (undergoing appropriate treatment and with progression of clinical symptoms) or clinically significant bacterial, viral, or fungal infections within 1 month before enrollment.\n* Patients with confirmed Hepatitis B or Hepatitis C infections.\n* Patients with confirmed seropositivity or positive nucleic acid amplification test (NAAT) for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV).\n* Patients with a history of stroke.\n* Serum conjugated (direct) bilirubin \\> 2× the upper limit of normal for age, or serum alanine transaminase (ALT) \\> 3× the upper limit of normal for age as per the local laboratory. Participants with hyperbilirubinemia or elevated aspartate aminotransferase (AST) as the result of hyperhemolysis, or with a severe drop in hemoglobin post blood transfusion, are not excluded as long as these values downtrend and return to acceptable limits subsequently.\n* Left ventricular shortening fraction \\< 25% or ejection fraction \\< 45% by echocardiogram.\n* Estimated creatinine clearance less than 60 mL/min/1.73m\\^2.\n* Diffusion capacity of carbon monoxide (DLCO) \\< 50% (adjusted for hemoglobin) OR baseline oxygen saturation \\< 85% in patients unable to perform pulmonary function tests.\n* Prior HCT or gene therapy.\n* Known hepatic cirrhosis, bridging hepatic fibrosis, or active hepatitis. Appropriate ultrasound or magnetic resonance (MR) imaging may be used to define the presence and degree of cirrhosis. Liver biopsy may be performed at the discretion of the attending physician or principal investigator if there are concerns regarding the presence of severe hepatic fibrosis or cirrhosis such that participation in this trial will not be in the patient's best interest.\n* Active known malignancy, myelodysplasia, abnormal cytogenetics, or immunodeficiency.\n* Patients with history of a significant bleeding disorder.\n* Cerebrovascular procedure within 6 months, including pial synangiosis for moyamoya.\n* Patients with history of untreated moyamoya disease or presence of moyamoya disease at screening that in the opinion of the investigator puts the subjects at the risk of bleeding.\n* Evidence of a pathogenic clonal variant in any candidate gene detected by a standard, licensed next-generation sequencing clinical assay for gene mutations associated hematological malignancies.\n* Patients with history of intolerance, contraindication, or known sensitivity to plerixafor or motixafortide or busulfan. Prior anaphylactic reaction with excipients of the proposed product.\n* Patients with participation in another clinical study with an investigational drug/product within 30 days of screening or fewer than 5 half-lives of the investigational agent whichever is longer from screening.\n* Patients with history of alloimmunization to RBC antigens and for whom the investigator anticipates that there will be insufficient RBC units available for the duration of the study.","locations":[{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Akshay Sharma, MBBS, MSc","phone":"888-226-4343","email":"referralinfo@stjude.org"}],"primaryOutcomes":["Incidence of neutrophil engraftment by day +42 after infusion of the CRISPR/Cas9-edited CD34+ HSPCs.","Incidence of platelet engraftment by day +60 after infusion of the CRISPR/Cas9-edited CD34+ HSPCs.","Sustenance of multi-lineage engraftment and polyclonal hematopoiesis as measured by counts of different clones of myeloid cells, T cells, B cells, and NK cells at 1 year after infusion of the CRISPR/Cas9-edited CD34+ HSPCs.","Frequency of off-target editing after infusion of the CRISPR/Cas9-edited CD34+ HSPCs.","Occurrence of secondary graft failure, clonal hematopoiesis, MDS, or AML"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["memphis-tennessee"],"enrichment":{"headline":"Phase 1: testing Plerixafor for Sickle Cell Disease","inPlainEnglish":"This study is being done to test the safety of a new treatment called gene editing in Sickle Cell Disease (SCD) patients and to see if a single dose of this genetically modified cellular product will increase the amount of a certain hemoglobin called fetal hemoglobin (HbF) and help reduce the symptoms of SCD. Primary Objective * To assess the safety of autologous infusion of clustered regularly interspaced palindromic repeats (CRISPR)/ CRISPR associated protein (Cas9)-edited CD34+ hematopoietic stem and progenitor cells (HSPCs) in patients with severe SCD.","whoItsFor":["Ages 18 Years to 24 Years","Age ≥18 years and ≤24.9 years","Failure, intolerance, or refusal of hydroxyurea therapy","Patients must be eligible for autologous stem cell transplant as per investigator's judgment","Males must agree to use effective contraception from start of mobilization through at least 6 months post-infusion"],"whoShouldSkip":["Availability of an human leukocyte antigen (HLA)-matched sibling who is willing and able to donate an appropriate graft for hematopoietic cell transplantation (HCT)","Karnofsky or Lansky performance score \\< 80","Pregnant, as confirmed by positive serum or urine pregnancy test within 14 days before enrollment (if female)","Uncontrolled (undergoing appropriate treatment and with progression of clinical symptoms) or clinically significant bacterial, viral, or fungal infections within 1 month before enrollment","Patients with confirmed Hepatitis B or Hepatitis C infections","Patients with confirmed seropositivity or positive nucleic acid amplification test (NAAT) for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus (HTLV)","Patients with a history of stroke"],"whatHappens":"If you join, the listed intervention(s) are Plerixafor, Busulfan, or Gene-modified CD34+ cells. The registry lists allocation as na. This study is being done to test the safety of a new treatment called gene editing in Sickle Cell Disease (SCD) patients and to see if a single dose of this genetically modified cellular product will increase the amount of a certain hemoglobin called fetal hemoglobin (HbF) and help reduce the symptoms of SCD.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 25 people at Memphis. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.843Z"},{"nctId":"NCT06507657","title":"Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure","officialTitle":"Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Minnesota","sponsorClass":"OTHER","summary":"Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily.\n\nThe purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.","conditions":["Hypertension","Cardiovascular Diseases"],"keywords":[],"interventions":[{"type":"DRUG","name":"empagliflozin"},{"type":"DRUG","name":"Placebo tablet"}],"enrollment":80,"startDate":"2024-12-12","completionDate":"2029-01-15","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>60 years of age\n* Clinical diagnosis of hypertension\n* Body mass index ≥30kg/m2\n* We will screen for participants with an echocardiogram within 60 days of the baseline visit\n\nExclusion Criteria:\n\n* Female participants who are pregnant, lactating, or of child bearing potential\n* History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \\>7.0% at Visit 1\n* Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record\n* Any LVEF measure of ≤40% on past echocardiogram\n* Moderate or severe valve disease on echocardiogram\n* History of genitourinary infection\n* eGFR \\<60 ml/min/1.73 m2 at Visit 1\n* Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors\n* Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months\n* Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations\n* Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease\n* Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening\n* Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit\n* Inadequate quality echocardiographic images\n* Unstable coronary syndromes\n* Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1.\n* Non-English speaking individuals","locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle Pitt","phone":"612-625-6678","email":"henni032@umn.edu"}],"primaryOutcomes":["change in LA function"],"hasResults":false,"conditionSlugs":["type-2-diabetes","heart-failure","hypertension"],"drugSlugs":["empagliflozin"],"locationSlugs":["minneapolis-minnesota"],"enrichment":{"headline":"Early phase 1: testing empagliflozin for Hypertension","inPlainEnglish":"Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys.","whoItsFor":["Ages 60 Years to any","Age \\>60 years of age","Clinical diagnosis of hypertension","Body mass index ≥30kg/m2","We will screen for participants with an echocardiogram within 60 days of the baseline visit"],"whoShouldSkip":["Female participants who are pregnant, lactating, or of child bearing potential","History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \\>7.0% at Visit 1","Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record","Any LVEF measure of ≤40% on past echocardiogram","Moderate or severe valve disease on echocardiogram","History of genitourinary infection","eGFR \\<60 ml/min/1.73 m2 at Visit 1"],"whatHappens":"If you join, the listed intervention(s) are empagliflozin, or Placebo tablet. The registry lists allocation as randomized. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 80 people at Minneapolis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.616Z"},{"nctId":"NCT06507787","title":"Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects","officialTitle":"Evaluation of the Impact of the EDIT-B® Blood Test on the Health Status of Patients Presenting a Major Depressive Episode. Clinical Utility and Medico-Economic Aspects","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alcediag","sponsorClass":"INDUSTRY","summary":"Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior. The Diagnostic and Statistical Manual of Mental Disorders (DSM) defines a Major Depressive Episode (MDE) by a combination of at least five different symptoms, with at least one depressed mood or loss of interest. MDEs can occur in isolation or as part of Major Depressive Disorder (MDD) or bipolar disorder (BD). Bipolar disorders affect 2% of the world's population and are defined by episodes of mania (Type I BD) or hypomania (Type II BD) alternating with episodes of depression and periods of remission.\n\nDepression occurring whether in the context of BD or MDD is defined with the same clinical criteria. However, the pharmacological treatments are different in the two groups. In particular, antidepressants prescribed without a thymoregulator in bipolar patients can lead to a worsening of the episode, favoring suicidal behavior or a manic turn.\n\nThe average interval between the onset of BD symptoms and appropriate diagnosis is estimated to be approximately 7 years, which delays appropriate management and treatment and increases the risk of suicide.\n\nBiological markers able to differentiate between the different types of depression were lacking before the advent of EDIT-B®; one of the main objectives of this research is to measure the clinical impact of the use of EDIT-B® in the short and medium term on the management of patients with BD and major depression. The health economic aspect will also be considered.\n\nIn total, 450 patients in two different groups (EDIT-B® group and control group) will be recruited over a study timeline of 24 months. Study participation is over 6 months with 4 visits.","conditions":["Bipolar Disorder","Major Depressive Disorder"],"keywords":["Clinical Utility","Bipolar Disorder","Major Depressive Disorder"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"EDIT-B test"},{"type":"DIAGNOSTIC_TEST","name":"EDIT-B test (without giving result)"}],"enrollment":450,"startDate":"2025-02-03","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19)\n* Age between 18 and 65 years, gender indifferent\n* Benefitting from health insurance coverage\n* Having signed an informed consent and agreed to follow the study protocol to completion\n* Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria:\n\n  * More than 3 episodes of MDE in personal medical history\n  * Psychotic symptoms\n  * Family history of bipolar disorder\n  * Onset of the first MDE before the age of 25\n  * Atypical symptoms or mixed features during depressive episodes\n  * Addiction\n  * Personal history of suicide attempts\n  * Resistance to antidepressants\n  * Postpartum depression within 6 months of birth\n\nExclusion Criteria:\n\n* Depression in the context of schizophrenia or autism spectrum disorder\n* Patient with a well-established diagnosis of bipolar disorder\n* Patients who is already receiving a mood stabilizer\n* Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation\n* Neurodegenerative diseases\n* Pregnant women","locations":[{"facility":"CH Erstein","city":"Erstein","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AP-HP Corentin Celton","city":"Issy-les-Moulineaux","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Etablissement Public de Santé Mentale (EPSM) 74","city":"La Roche-sur-Foron","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique Villa des Roses","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Le Clos Montaigne","city":"Montrond-les-Bains","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GHU Paris Psychiatrie et Neurosciences","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Médicale de Ville d'Avray","city":"Ville-d'Avray","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mary Menhem, PharmD, MSc","phone":"+33788970700","email":"mary.menhem@alcediag-alcen.com"},{"name":"Benjamin Dubuc","phone":"","email":"benjamin.dubuc@alcediag-alcen.com"}],"primaryOutcomes":["Improvement in depressive symptoms between inclusion and 15-16 weeks visit."],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["erstein-france","issy-les-moulineaux-france","la-roche-sur-foron-france","lyon-france","montrond-les-bains-france","paris-france","ville-davray-france"],"enrichment":{"headline":"Not a traditional drug phase: EDIT-B test for Bipolar Disorder","inPlainEnglish":"Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide. It is associated with a significant increase in mortality, mainly due to suicidal behavior.","whoItsFor":["Ages 18 Years to 65 Years","Patients with a MDE, moderate to severe (DSM V criteria and MADRS score ≥19)","Age between 18 and 65 years, gender indifferent","Benefitting from health insurance coverage","Patients for whom there is doubt regarding a bipolar disorder diagnosis, and/or presenting one or more of the following criteria:","More than 3 episodes of MDE in personal medical history","Family history of bipolar disorder","Onset of the first MDE before the age of 25"],"whoShouldSkip":["Depression in the context of schizophrenia or autism spectrum disorder","Patient with a well-established diagnosis of bipolar disorder","Patients who is already receiving a mood stabilizer","Severe somatic diseases that may interfere with the follow-up or associated with treatments at risk of secondary manic decompensation","Neurodegenerative diseases"],"whatHappens":"If you join, the listed intervention(s) are EDIT-B test, or EDIT-B test (without giving result). The registry lists allocation as randomized. Depression is one of the most common mental disorders, affecting nearly 10% of men and 20% of women worldwide.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 450 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.731Z"},{"nctId":"NCT06507930","title":"The COMPASSION Study","officialTitle":"The COMPASSION Study: Applying Telehealth to Innovate and Strengthen Connections for Patients With Metastatic Breast Cancer Receiving Hospice Care","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Dana-Farber Cancer Institute","sponsorClass":"OTHER","summary":"The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.","conditions":["Breast Cancer","Metastatic Breast Cancer","Advanced Breast Cancer","Unresectable Breast Carcinoma"],"keywords":["Breast Cancer","Metastatic Breast Cancer","Advanced Breast Cancer","Unresectable Breast Cancer","Hospice Care"],"interventions":[{"type":"OTHER","name":"Telehealth Hospice Visits"}],"enrollment":200,"startDate":"2024-09-01","completionDate":"2028-10-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient of any gender with unresectable locally advanced or metastatic breast cancer\n* Eligible for in-home hospice services and referred by DFCI clinical team to in-home hospice \\</= 1 week before enrollment\n* Ability to conduct video or phone check-ins, even if assistance required.\n* Able to provide verbal consent with a willingness to take a survey at 4-6 weeks, if medically able\n* Hospice setting is within Massachusetts\n* Non-English language allowed but interpreter services must be present at each meeting and will be coordinated by scheduling team\n* Willingness to provide a caregiver/loved one's contact information for survey contact at 4 weeks after enrollment\n\nExclusion Criteria:\n\n* Unable to provide verbal consent\n* Hospice care planned outside of a home setting (note: if participants start out in a home hospice setting but later transition their hospice care to an inpatient setting, enrollment is allowed as long as they started in a home setting)\n* Hospice setting outside of Massachusetts\n* Individuals who are under the age of 18, as this is not a project focused on pediatric patients.","locations":[{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Claire Smith, MD","phone":"617-632-3800","email":"claire_smith@dfci.harvard.edu"}],"primaryOutcomes":["Proportion of Participant Intervention Completion"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Telehealth Hospice Visits for Breast Cancer","inPlainEnglish":"The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.","whoItsFor":["Ages 18 Years to any","Patient of any gender with unresectable locally advanced or metastatic breast cancer","Eligible for in-home hospice services and referred by DFCI clinical team to in-home hospice \\</= 1 week before enrollment","Ability to conduct video or phone check-ins, even if assistance required","Hospice setting is within Massachusetts","Non-English language allowed but interpreter services must be present at each meeting and will be coordinated by scheduling team","Willingness to provide a caregiver/loved one's contact information for survey contact at 4 weeks after enrollment"],"whoShouldSkip":["Hospice care planned outside of a home setting (note: if participants start out in a home hospice setting but later transition their hospice care to an inpatient setting, enrollment is allowed as long as they started in a home setting)","Hospice setting outside of Massachusetts","Individuals who are under the age of 18, as this is not a project focused on pediatric patients"],"whatHappens":"If you join, the listed intervention(s) are Telehealth Hospice Visits. The registry lists allocation as randomized. The aim of this research study is to better understand the in-home hospice experience for participants, caregivers, hospice nurses, and oncology providers by conducting telehealth check-ins between participants and caregivers and oncology care teams.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.944Z"},{"nctId":"NCT06511908","title":"Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","officialTitle":"An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...","conditions":["Suicide","Depressive Disorder, Treatment-Resistant","Ketamine","Molecular Mechanisms of Pharmacological Action","Neurotransmitter Agents","Excitatory Amino Acid Agents","Physiological Effects of Drugs","Depressive Disorder, Major","Depressive Disorder","Depression","Mental Disorders","Mood Disorders","Behavioral Symptoms"],"keywords":["Major Depressive Disorder","Ketamine","Biomarkers","Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Neurobiology","Glutamate","Hydroxynorketamine"],"interventions":[{"type":"DRUG","name":"(2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg)"},{"type":"DRUG","name":"Placebo"}],"enrollment":50,"startDate":"2024-11-06","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\<12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4/5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal/urologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U/L\n    * Alanine aminotransferase (ALT) \\> 55 U/L\n    * Aspartate aminotransferase (AST) \\> 34 U/L\n    * Total bilirubin (TB) \\> 1.2 mg/dL\n    * Direct bilirubin (DB) \\> 0.5 mg/dL\n    * 25-hydroxyvitamin D \\< 20 ng/mL\n    * Folate \\< 2ng/mL\n    * Vitamin B12 \\< 200 pg/mL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\<60mL/min.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Solaleh Azimipour","phone":"(301) 768-0049","email":"solaleh.azimipour@nih.gov"}],"primaryOutcomes":["Change from baseline on Montgomery-Asberg Depression Rating Scale total scores"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg) for Suicide","inPlainEnglish":"Background: Major depressive disorder (major depression) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat major depression, but it can take a long time for them to be effective.","whoItsFor":["Ages 18 Years to 70 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availability for the duration of the study","18 to 70 years of age","All participants must have undergone a screening assessment under protocol 01-M-0254","Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\<12 within one week of study entry and upon entry into Phase II","Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen","For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II","Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II","Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II","Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II","Ongoing treatment with moderate or strong CYP3A4/5 inhibitors or inducers","Lifetime history of deep brain stimulation"],"whatHappens":"If you join, the listed intervention(s) are (2R,6R)-hydroxynorketamine (0.25 to 2.0 mg/kg), or Placebo. The registry lists allocation as randomized. Background: Major depressive disorder (major depression) is a serious mental illness that can put people at risk of self-harm and death.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.788Z"},{"nctId":"NCT06512220","title":"Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)","officialTitle":"Imaging the Effects of Serotonin 2A Receptor Modulation on Synaptic Density in Treatment-resistant Depression (SYNVEST)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Centre for Addiction and Mental Health","sponsorClass":"OTHER","summary":"Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.\n\nThe purpose of this study is to use an established SV2A radiotracer produced at our Centre to determine the feasibility of integrating PET imaging in to psilocybin trials. The preliminary imaging data will assess whether psilocybin's antidepressant effects are related to changes in synaptic density in adults with TRD, and whether any changes in synaptic density are associated with psilocybin's actions on the 5-HT2AR.","conditions":["Treatment Resistant Depression"],"keywords":["Psilocybin","Psychedelics","Clinical Trial","Positron-Emission Tomography","Treatment Resistant Depression","Neurophysiology Testing","Magnetic Resonance Imaging"],"interventions":[{"type":"DRUG","name":"Psilocybin 25 mg"},{"type":"DRUG","name":"Risperidone 1 MG"}],"enrollment":12,"startDate":"2025-04-21","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults 18 to 65 years old;\n2. Must be deemed to have capacity to provide informed consent;\n3. Must sign and date the informed consent form;\n4. Stated willingness to comply with all study procedures;\n5. Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;\n6. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;\n7. Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score \\> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration based on the Antidepressant Treatment History Form Short Form (ATHF-SF) (Sackeim et al., 2019); there is no upper limit on the number of treatment failures;\n8. Ability to take oral medication;\n9. Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;\n10. Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; and\n11. Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.\n\nExclusion Criteria:\n\n1. Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;\n2. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);\n3. Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);\n4. Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;\n5. Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;\n6. Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;\n7. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical history form and discussions with the participant;\n8. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.\n9. Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;\n10. History of allergy or contraindication to risperidone\n11. Current or past traumatic brain injury or other neurological/neurodegenerative disorder\n12. Unable or unwilling to undergo PET or MRI scanning (e.g. claustrophobia, pacemaker);\n13. Blood disorders, disorders of coagulation, or ongoing use of anticoagulant medication\n14. Any disability that may prevent the participant from completing study requirements (e.g., non-correctable clinically significant sensory impairment such as not hearing well enough to communicate with study personnel during scans, or physical disability that does not allow them to lie still on the scanner bed for 1-2 hours);\n15. Participant exceeds the annual or lifetime amount of radiation\n16. Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.","locations":[{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily Gilbert, MSc","phone":"416-535-8501","email":"emily.gilbert@camh.ca"},{"name":"Psychedelics Research","phone":"","email":"psychedelics.research@camh.ca"}],"primaryOutcomes":["Feasibility of obtaining PET imaging scans before and after administration of psilocybin (25 mg) with and without risperidone (1 mg) in adults with TRD."],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 2: testing Psilocybin 25 mg for Treatment Resistant Depression","inPlainEnglish":"Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects. In healthy volunteers, the psychedelic effects of psilocybin have been shown to be blocked by administration of certain medications such as risperidone.","whoItsFor":["Ages 18 Years to 65 Years","Adults 18 to 65 years old;","Stated willingness to comply with all study procedures;","Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;","Primary DSM-5 diagnosis of non-psychotic major depression, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;","Ability to take oral medication;","Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 3 months prior to screening and agreement to use such a method during study participation;","Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and whose physician confirms that it is safe for them to do so; and"],"whoShouldSkip":["Pregnant as assessed by a urine pregnancy test at Screening (V1) or individual's that intend to become pregnant during the study or are breastfeeding;","Treatment with another investigational drug or other intervention within 30 days of Screening (V1);","Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);","Have a DSM-5 diagnosis of substance use disorder (use of tobacco is permitted) within the preceding 6 months;","Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;","Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I disorder as determined by the family medical history form and discussions with the participant;","Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 25 mg, or Risperidone 1 MG. The registry lists allocation as randomized. Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 12 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.098Z"},{"nctId":"NCT06513156","title":"Continuum of Care in Hospitalized Patients With Opioid/Stimulant Use Disorder and Infectious Complications From Drug Use","officialTitle":"Continuum of Care in Hospitalized Patients With Opioid or Stimulant Use Disorder and Infectious Complications of Drug Use - Substance Use/ID Integrated Clinic vs. TAU to Prevent Infection Related Readmission","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Elana Rosenthal","sponsorClass":"OTHER","summary":"This is a two-group randomized controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.","conditions":["Opioid Use Disorder","Injection Related Infections","Stimulant Use Disorder"],"keywords":["Delivery of Health Care, Integrated","Opioid use disorder","Serious Injection Related Infections","Stimulant Use Disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Integrated Infectious Diseases and Substance Use Disorder Clinic (IC)"}],"enrollment":304,"startDate":"2024-10-01","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)\n3. Injection opioid or stimulant use in past 90 days - per patient self-report\n4. Active suspected or confirmed qualifying infection (see list) at time of admission.\n\nQualifying infections:\n\n* Non-vertebral osteomyelitis\n* Vertebral osteomyelitis or discitis\n* Epidural, subdural, or extradural abscess\n* Intracranial or intraspinal abscess\n* Native joint septic arthritis\n* Prosthetic joint septic arthritis\n* Blood stream infection (bacterial or fungal)\n* Native valve Endocarditis\n* Prosthetic valve endocarditis\n* Cardiac Implantable electronic device infection\n* Infectious pseudoaneurysm and aneurysm\n* Infected vascular graft\n* Septic venous thrombosis\n* Skin and Soft tissue infection (cellulitis, skin abscess, necrotizing fasciitis)\n* Infected skin ulcer\n* Orthopedic hardware infection\n* Muscle abscess/myositis\n* Central nervous system infection (bacterial or fungal)\n* Bacterial or fungal ophthalmologic infection\n* Other abscess\n* Pulmonary septic emboli\n* Other acute bacterial or fungal infection deemed appropriate by site study team\n\nExclusion Criteria:\n\n* 1\\. Infection due to a cause other than injection drug use, per determination of a site PI.\n\n  2\\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment.\n\n  3\\. Unwilling to provide informed consent 4. Unable to receive potential interventions due to geography 5. On comfort measures or planned for discharge to hospice care 6. Incarcerated at the time of hospitalization 7. Other criteria at the discretion of the site investigator","locations":[{"facility":"George Washington University","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rachel Silk","phone":"301-326-7652","email":"rsilk@ihv.umaryland.edu"}],"primaryOutcomes":["Infection Rehospitalization"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","atlanta-georgia","baltimore-maryland","morgantown-west-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Integrated Infectious Diseases and Substance Use Disorder Clinic (IC) for Opioid Use Disorder","inPlainEnglish":"This is a two-group randomly assigned controlled trial conducted at five hospitals across the U.S. designed to test the effectiveness of an Integrated infectious diseases/Substance Use Disorder outpatient clinic (IC) compared to treatment as usual aimed at reducing infection related readmissions and improving health outcomes in people hospitalized with an infection related to injecting opioids or stimulants.","whoItsFor":["Ages 18 Years to any","Admitted to study hospital (defined as hospitalized with a primary team that is not Emergency Medicine)","Injection opioid or stimulant use in past 90 days - per patient self-report","Active suspected or confirmed qualifying infection (see list) at time of admission","Qualifying infections:","Non-vertebral osteomyelitis","Vertebral osteomyelitis or discitis","Epidural, subdural, or extradural abscess"],"whoShouldSkip":["1\\. Infection due to a cause other than injection drug use, per determination of a site PI","2\\. Inability to provide consent due to circumstance (e.g., sedated, intubated), language, or cognitive impairment"],"whatHappens":"If you join, the listed intervention(s) are Integrated Infectious Diseases and Substance Use Disorder Clinic (IC). The registry lists allocation as randomized. This is a two-group randomly assigned controlled trial conducted at five hospitals across the U.S.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 304 people at 4 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.486Z"},{"nctId":"NCT06515613","title":"A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors","officialTitle":"A Phase 1, First in Human Study of CTIM-76, a Claudin-6 (CLDN6)-Directed Bispecific Antibody, in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Context Therapeutics Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1a/1b, open-label, dose escalation and expansion study to evaluate the safety and efficacy of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).","conditions":["Platinum-resistant Ovarian Cancer","Testicular Cancer","Endometrial Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"CTIM-76"}],"enrollment":156,"startDate":"2024-07-10","completionDate":"2028-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer.\n* Participants with measurable disease per RECIST 1.1.\n* ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks.\n* Participants with adequate organ function.\n\nExclusion Criteria:\n\n* Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression.\n* Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study.\n* Concurrent participation in another investigational clinical trial.","locations":[{"facility":"University of Arkansas Winthrop P. Rockefeller Cancer Institute","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precision NextGen Oncology & Research Center","city":"Beverly Hills","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"SCRI at Denver Health","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabrail Cancer Center","city":"Canton","state":"Ohio","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Providence Cancer Institute of Oregon","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fox Chase Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Women & Infants Hospital of Rhode Island","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt-Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI at Mary Crowley","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Context Clinical Development","phone":"267-225-7416","email":"cntx-ctim76-101@contexttherapeutics.com"}],"primaryOutcomes":["Incidence of Dose Limiting Toxicities (DLTs)","Overall response rate (ORR)"],"hasResults":false,"conditionSlugs":["ovarian-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","beverly-hills-california","denver-colorado","boston-massachusetts","omaha-nebraska","hackensack-new-jersey","new-york-new-york","durham-north-carolina","canton-ohio","portland-oregon","philadelphia-pennsylvania","providence-rhode-island","nashville-tennessee","dallas-texas","london-united-kingdom"],"enrichment":{"headline":"Phase 1: testing CTIM-76 for Platinum-resistant Ovarian Cancer","inPlainEnglish":"This is a Phase 1a/1b, open-label, dose escalation and expansion study to measure the safety and how well it works of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).","whoItsFor":["Ages 18 Years to any","Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer","Participants with measurable disease per RECIST 1.1","ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks","Participants with adequate organ function"],"whoShouldSkip":["Evidence of central nervous system metastases, leptomeningeal disease or spinal cord compression","Uncontrolled significant active infection or any medical or other condition that in opinion of the Investigator would preclude the participant's participation in the study","Concurrent participation in another investigational clinical trial"],"whatHappens":"If you join, the listed intervention(s) are CTIM-76. The registry lists allocation as na. This is a Phase 1a/1b, open-label, dose escalation and expansion study to measure the safety and how well it works of CTIM-76 (study drug), a CLDN6-directed T cell-engaging bispecific antibody , in participants with platinum-refractory/resistant ovarian cancer (PRROC) and other advanced CLDN6-positive solid tumors (i.e., testicular and endometrial).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 156 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.156Z"},{"nctId":"NCT06516653","title":"Post Market Study for VasQ, an External Support Implant for Arteriovenous Fistula","officialTitle":"Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Laminate Medical Technologies","sponsorClass":"INDUSTRY","summary":"VasQ is an external support implant for arteriovenous fistulas created for dialysis access.\n\nThis is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms:\n\n* Treatment arm: End to side fistula supported with VasQ\n* Control: Standard of care end to side fistula","conditions":["End Stage Renal Disease"],"keywords":[],"interventions":[{"type":"DEVICE","name":"VasQ"},{"type":"PROCEDURE","name":"Arteriovenous fistula creation for dialysis vascular access"}],"enrollment":300,"startDate":"2025-01-13","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.\n2. Male and non-pregnant female participants.\n3. Age 18-80 years\n4. Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.\n\nExclusion Criteria:\n\n1. Index procedure being a revision surgery of an existing fistula.\n2. Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)\n3. Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.\n4. Known central venous stenosis or obstruction on the side of surgery.\n5. Pre-existing stents or stent grafts in the access circuit.\n6. Planned subsequent fistula superficialization procedure.\n7. Known coagulation disorder.\n8. Known allergy to nitinol.\n9. Expected kidney transplant within 12 months of enrollment.\n10. Inability to give consent and/or comply with the study follow up schedule.\n11. Insufficient or borderline life expectancy to allow for completion of study procedures and follow-up (12 Months).\n12. Participation in another interventional study that in the judgment of the investigator could confound study results.","locations":[{"facility":"Fresenius Vascular Care Long Beach","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarasota Memorial Health Care System","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grady Memorial Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta VA Medical Center","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Clinic Foundation","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Greenwood Leflore Hospital","city":"Greenwood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azura Surgery Center Las Vegas","city":"Las Vegas","state":"Nevada","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fresenius Vascular Care Columbia","city":"Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James E. Gardner MD, P.C.","city":"Memphis","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairlawn Surgery Center","city":"Roanoke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Galit Itzhaki","phone":"+972-3-6344246","email":"galit@laminatemedical.com"}],"primaryOutcomes":["Fistula functional success"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["long-beach-california","sarasota-florida","atlanta-georgia","decatur-georgia","new-orleans-louisiana","boston-massachusetts","greenwood-mississippi","las-vegas-nevada","columbia-south-carolina","memphis-tennessee","nashville-tennessee","houston-texas","roanoke-virginia"],"enrichment":{"headline":"Not a traditional drug phase: VasQ for End Stage Renal Disease","inPlainEnglish":"VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomly assigned, controlled, open label trial enrolling 300 patients randomly assigned into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula","whoItsFor":["Ages 18 Years to 80 Years","Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study","Male and non-pregnant female participants","Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months"],"whoShouldSkip":["Index procedure being a revision surgery of an existing fistula","Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)","Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ","Known central venous stenosis or obstruction on the side of surgery","Pre-existing stents or stent grafts in the access circuit","Planned subsequent fistula superficialization procedure","Known coagulation disorder"],"whatHappens":"If you join, the listed intervention(s) are VasQ, or Arteriovenous fistula creation for dialysis vascular access. The registry lists allocation as randomized. VasQ is an external support implant for arteriovenous fistulas created for dialysis access.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at 13 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.508Z"},{"nctId":"NCT06518720","title":"Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND)","officialTitle":"Treatment With Psilocybin for Chronic Neuropathic Pain and Depression (TRANSCEND): An Open-Label Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Centre for Addiction and Mental Health","sponsorClass":"OTHER","summary":"Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomized clinical trials (RCTs) showing large and sustained antidepressant effects.\n\nThe purpose of this study is to assess the feasibility, tolerability, and preliminary efficacy of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.","conditions":["Treatment Resistant Depression","Chronic Pain"],"keywords":["Psilocybin","Psychedelics","Clinical Trial","Chronic Pain","Treatment Resistant Depression"],"interventions":[{"type":"DRUG","name":"Psilocybin 25 mg"}],"enrollment":16,"startDate":"2025-04-01","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults 18 to 65 years old;\n2. Are outpatients;\n3. Must be deemed to have capacity to provide informed consent;\n4. Must sign and date the informed consent form;\n5. Stated willingness to comply with all study procedures;\n6. Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;\n7. Primary DSM-5 diagnosis of non-psychotic MDD, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;\n8. Participants diagnosed with treatment-resistant depression defined as individuals with a baseline HamD-17 score \\> 14 and that have not responded to two or more separate trials of antidepressants at an adequate dosage and duration based on the Antidepressant Treatment History Form Short Form (ATHF-SF) (Sackeim et al., 2019); there is no upper limit on the number of treatment failures;\n9. Diagnosis of chronic neuropathic pain as determined by a pain specialist and confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire\n10. Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference score of ≥ 60, as well as mean pain intensity scores ≥ 5 on a numeric rating scale\n11. Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms\n12. Ability to take oral medication;\n13. Individuals with an eGFR above 40mL/min/1.73m² and all blood work on clinical laboratory tests assessed as not clinically significant by study delegate physician at Screening (V1)\n14. Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;\n15. Individuals who are willing to taper off current antidepressant and antipsychotic medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so; and\n16. Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.\n\nExclusion Criteria:\n\n1. Pregnant as assessed by a urine pregnancy test at Screening (V1) or individuals that intend to become pregnant during the study or are breastfeeding;\n2. Treatment with another investigational drug or other intervention within 30 days of Screening (V1);\n3. Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);\n4. Have a DSM-5 diagnosis of substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;\n5. Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;\n6. Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;\n7. Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;\n8. Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension, low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.\n9. Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;\n10. Individuals who are currently taking methadone, buprenorphine or \\> 100 milligrams of morphine (or morphine equivalents).\n11. Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.","locations":[{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily Gilbert, MSc","phone":"4165358501","email":"emily.gilbert@camh.ca"},{"name":"Psychedelics Research","phone":"","email":"psychedelics.research@camh.ca"}],"primaryOutcomes":["Percentage of participants recruited, enrolled and retained (feasibility) and the number of serious adverse events and serious adverse drug reactions associated with administration of 25 mg of psilocybin (safety)."],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 2: testing Psilocybin 25 mg for Treatment Resistant Depression","inPlainEnglish":"Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects. this study wants to assess the feasibility, tolerability, and preliminary how well it works of psilocybin therapy for adults with chronic neuropathic pain and co-morbid treatment resistant depression.","whoItsFor":["Ages 18 Years to 65 Years","Adults 18 to 65 years old;","Stated willingness to comply with all study procedures;","Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;","Primary DSM-5 diagnosis of non-psychotic major depression, single or recurrent, based on the Structured Clinical Interview for DSM-5 (SCID-5) administered at the first screening visit;","Diagnosis of chronic neuropathic pain as determined by a pain specialist and confirmed with the standardized Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) questionnaire","Moderate-to-severe neuropathic pain determined by Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference score of ≥ 60, as well as mean pain intensity scores ≥ 5 on a numeric rating scale","Previous trials of at least two medications recommended in the Canadian consensus guidelines on the management of neuropathic pain with no self-reported meaningful improvement in symptoms"],"whoShouldSkip":["Pregnant as assessed by a urine pregnancy test at Screening (V1) or individuals that intend to become pregnant during the study or are breastfeeding;","Treatment with another investigational drug or other intervention within 30 days of Screening (V1);","Have initiated psychotherapy in the preceding 12 weeks prior to Screening (V1);","Have a DSM-5 diagnosis of substance use disorder (recreational use of tobacco, alcohol, cannabis and prescribed opioids are permitted) within the preceding 6 months;","Have active suicidal ideation with intent and plan as determined by item 3 of the HamD-17;","Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;","Presence of baseline prolonged QTc or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 25 mg. The registry lists allocation as na. Psilocybin, the chemical component of \"magic mushrooms\", has been administered with psychotherapy in several randomly assigned clinical trials (RCTs) showing large and sustained antidepressant effects.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 16 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.097Z"},{"nctId":"NCT06522022","title":"PTSD Screening in Pregnant Black Women","officialTitle":"Comparing Two Screening Approaches for PTSD to Improve Health Outcomes in Pregnant Black Women","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Emory University","sponsorClass":"OTHER","summary":"This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.","conditions":["Pregnancy Early","PTSD"],"keywords":["Pregnancy","Black Women","Screening for Maternal PTSD","Obstetric Care","African-American Women"],"interventions":[{"type":"BEHAVIORAL","name":"Culturally Responsive SBIRT for OB"},{"type":"BEHAVIORAL","name":"Brief Screening for PTSD"}],"enrollment":804,"startDate":"2025-02-20","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 18+ years old,\n* Ability to provide informed consent,\n* English-speaking,\n* Willingness to participate in the study,\n* Self-identification as Black or African American,\n* Pregnant and in the first trimester attending initial prenatal care visit,\n* Endorsement of at least one traumatic event in their lifetime.\n\nExclusion Criteria:\n\n* Active suicidality","locations":[{"facility":"Grady Health System","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Truman Medical Center (TMC) system","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Abigail Powers Lott, PhD, ABPP","phone":"404-712-0159","email":"abigail.lott@emoryhealthcare.org"}],"primaryOutcomes":["PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 (PCL-5) Score"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","kansas-city-missouri"],"enrichment":{"headline":"Not a traditional drug phase: Culturally Responsive SBIRT for OB for Pregnancy Early","inPlainEnglish":"This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.","whoItsFor":["Ages 18 Years to any","Willingness to participate in the study,","Self-identification as Black or African American,","Pregnant and in the first trimester attending initial prenatal care visit,","Endorsement of at least one traumatic event in their lifetime"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Culturally Responsive SBIRT for OB, or Brief Screening for PTSD. The registry lists allocation as randomized. This study will compare the effectiveness of two active screening interventions in improving post-traumatic stress disorder (PTSD) symptoms, maternal perinatal care utilization, satisfaction utilization of mental healthcare services, and maternal health and birth-related outcomes for Black pregnant women.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 804 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.412Z"},{"nctId":"NCT06523556","title":"Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia","officialTitle":"Phase 1b/2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN/MDS Overlap or High-Risk CMML","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Uma Borate","sponsorClass":"OTHER","summary":"This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth. By blocking the proteins, this may slow or halt the growth of the cancer. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN, MPN/MDS overlap or high risk CMML.","conditions":["Atypical Chronic Myeloid Leukemia","Chronic Myelomonocytic Leukemia","Myelodysplastic/Myeloproliferative Neoplasm","Recurrent Myelodysplastic/Myeloproliferative Neoplasm","Recurrent Myeloproliferative Neoplasm","Refractory Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic/Myeloproliferative Neoplasm","Refractory Myeloproliferative Neoplasm"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Axatilimab"},{"type":"DRUG","name":"Azacitidine"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration and Biopsy"},{"type":"OTHER","name":"Survey Administration"}],"enrollment":49,"startDate":"2024-08-02","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Age ≥ 18 years at the date of signing the informed consent form (ICF)\n* Morphologically confirmed diagnosis of the following based on 2016 World Health Organization (WHO) classification (Arber et al 2016): Phase 1b, patients with relapsed or refractory of any of the following; phase 2, patients with newly diagnosed of any of the following:\n\n  * Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model\n  * Atypical chronic myelocytic leukemia (aCML)\n  * MDS/MPN unclassified (MDS/MPN-U)\n  * Myeloproliferative neoplasm accelerated phase (MPN-AP)\n  * MPN-AP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) with intermediate-2 or high risk disease according to International Prostate Symptom Score (IPSS) as well as progression on or failure to respond to at least one line of therapy.\n  * Myelodysplastic syndrome/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) or MDS/MPN with SF3B1 mutation and thrombocytosis (MDS/MPN-SF3B1-T).\n  * Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)\n* PHASE Ib (RELAPSE \\[R\\]/ REFRACTORY \\[R\\]): Relapse/refractory patients who have received at least two cycles of disease directed therapy (prior therapies can include hypomethylating agents \\[HMAs\\], HMA combination therapies, and other disease directed therapies)\n* PHASE II (NEWLY DIAGNOSED PHASE): Newly diagnosed patients without prior treatment, including intensive induction chemotherapy. However, previous treatment with hydroxyurea, ruxolitinib, and/or up to 2 cycles of HMAs (decitabine, azacitidine, oral decitabine \\[INQOVI\\]) is permitted\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)\n* Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\\^2 (estimation based on Modification of Diet in Renal Disease \\[MDRD\\] formula, by local laboratory)\n* Patient is able to communicate with the investigator and has the ability to comply with the requirements of the study procedures\n* Women of childbearing potential and men, if not surgically sterilized, should use adequate contraception from 14 days prior to study entry and until 90 days after the last follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom\n\nExclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)\n* Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment\n* History of organ transplant or allogenic hematopoietic stem cell transplant\n* Participants with prior malignancy, except:\n\n  * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study.\n  * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible\n* Previous known allergy/sensitivity to components of axatilimab\n* History of acute or chronic pancreatitis\n* History of myositis","locations":[{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"The Ohio State University Comprehensive Cancer Center","phone":"800-293-5066","email":"OSUCCCClinicaltrials@osumc.edu"}],"primaryOutcomes":["Incidence of dose limiting toxicities","Overall response rate"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["columbus-ohio","portland-oregon"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Axatilimab for Atypical Chronic Myeloid Leukemia","inPlainEnglish":"This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML). Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth.","whoItsFor":["Ages 18 Years to any","Morphologically confirmed diagnosis of the following based on 2016 World Health Organization (WHO) classification (Arber et al 2016): Phase 1b, patients with relapsed or refractory of any of the following; phase 2, patients with newly diagnosed of any of the following:","Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model","Atypical chronic myelocytic leukemia (aCML)","MDS/MPN unclassified (MDS/MPN-U)","Myeloproliferative neoplasm accelerated phase (MPN-AP)","Myelodysplastic syndrome/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) or MDS/MPN with SF3B1 mutation and thrombocytosis (MDS/MPN-SF3B1-T)","Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)"],"whoShouldSkip":["Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)","Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment","History of organ transplant or allogenic hematopoietic stem cell transplant","Participants with prior malignancy, except:","Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study","Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible","Previous known allergy/sensitivity to components of axatilimab"],"whatHappens":"If you join, the listed intervention(s) are Axatilimab, Azacitidine, or Biospecimen Collection. The registry lists allocation as randomized. This phase Ib/II trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms (MPN), myeloproliferative neoplasm/myelodysplastic syndrome (MPN/MDS) overlap or high risk chronic myelomonocytic leukemia (CMML).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 49 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.833Z"},{"nctId":"NCT06525298","title":"EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors","officialTitle":"A Phase 1/2, Open Label Trial to Investigate the Safety, Tolerability, and Preliminary Efficacy of EIS-12656 as Single Agent and in Combination With a Poly-ADP Ribose Polymerase (PARP) Inhibitor, Trastuzumab Deruxtecan (T-DXd), or Darolutamide in Patients With Specified Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Eisbach Bio GmbH","sponsorClass":"INDUSTRY","summary":"This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).","conditions":["Advanced Solid Tumor","Homologous Recombination Deficiency","HRR Deficiency"],"keywords":[],"interventions":[{"type":"DRUG","name":"EIS-12656"},{"type":"DRUG","name":"PARPi"},{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Darolutamide (BAY 1841788)"}],"enrollment":240,"startDate":"2024-09-09","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Recurrent locally advanced or metastatic solid tumors\n* Homologous recombination deficient mutations\n* Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy\n* Measurable disease (RECIST 1.1 Criteria)\n* Adequate organ and bone marrow function\n* ECOG Performance Status 0 or 1\n* Life expectancy \\> 3 months\n\nExclusion Criteria:\n\n* History or evidence of any clinically relevant gastrointestinal disease\n* Radiation therapy within ≤2 weeks\n* Significant cardiovascular disease\n* Uncontrolled, active, symptomatic brain metastases","locations":[{"facility":"LSU Health Sciences Center- Shreveport","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Adrian Schomburg","phone":"+49 17621046886","email":"adrian@eisbach.bio"}],"primaryOutcomes":["Number and percentage of participants experiencing treatment-emergent adverse events (TEAEs)","Number and percentage of participants experiencing a dose limiting toxicity (DLT) (dose escalation part only)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["shreveport-louisiana","durham-north-carolina","houston-texas","seattle-washington"],"enrichment":{"headline":"Phase 1 / Phase 2: testing EIS-12656 for Advanced Solid Tumor","inPlainEnglish":"This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations. The trial consists of a dose escalation part (Phase 1) and a dose expansion part (Phase 2).","whoItsFor":["Ages 18 Years to any","Recurrent locally advanced or metastatic solid tumors","Homologous recombination deficient mutations","Progressed on at least on prior line of treatment or intolerant to additional effective standard therapy","Measurable disease (RECIST 1.1 Criteria)","Adequate organ and bone marrow function","how well you can do daily activities (ECOG score) 0 or 1","Life expectancy \\> 3 months"],"whoShouldSkip":["History or evidence of any clinically relevant gastrointestinal disease","Radiation therapy within ≤2 weeks","Significant cardiovascular disease","Uncontrolled, active, symptomatic brain metastases"],"whatHappens":"If you join, the listed intervention(s) are EIS-12656, PARPi, or Trastuzumab deruxtecan. The registry lists allocation as randomized. This trial investigates a new drug, EIS-12656, in participants with specified advanced solid tumors carrying pre-specified mutations.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 240 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.337Z"},{"nctId":"NCT06526195","title":"Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure","officialTitle":"Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Abbott Medical Devices","sponsorClass":"INDUSTRY","summary":"The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.","conditions":["Heart Failure","Heart Diseases","Cardiovascular Diseases","Pulmonary Hypertension"],"keywords":["Heart Failure","Left Ventricular Assist Device (LVAD)","Guideline Directed Medical Therapy (GDMT)","Non-inotrope Dependent","Pulmonary Artery Pressure","Hemodynamic Monitoring","Medical Management","CardioMEMS","HeartMate 3 (HM3)","Ambulatory Advanced Heart Failure"],"interventions":[{"type":"DEVICE","name":"CardioMEMS HF System"},{"type":"DEVICE","name":"HeartMate 3 Left Ventricular Assist System"},{"type":"OTHER","name":"Guideline Medical Directed Therapy"}],"enrollment":850,"startDate":"2024-12-13","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure\n2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²\n3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \\<50% of predicted peak VO2 value)\n4. NYHA Class IIIB or NYHA Class IV\n5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months\n6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant\n7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group\n\nRandomization Criteria:\n\n1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.\n2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.\n3. mean PAP ≥ 30 mmHg.\n4. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.\n\nSingle Arm Registry Criteria:\n\n1. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.\n2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.\n3. mean PAP \\<30 mmHg\n\nExclusion Criteria:\n\n1. Subject is \\< 18 years of age at the time of informed consent.\n2. Dependent on IV inotrope in the last 30 days.\n3. Contra-indications to HM3 LVAS or CardioMEMS HF system.\n4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.\n5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.\n6. Existence of ongoing MCS.\n7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.\n8. History of any solid organ transplant.\n9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.\n10. Presence of an active, uncontrolled infection.\n11. Complex congenital heart disease.\n12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.\n13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\\>1 episode) pulmonary embolism and/or deep vein thrombosis.\n14. Planned VAD or Bi-VAD support prior to enrollment.\n15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:\n\n    1. An INR ≥ 2.0 not due to anticoagulation therapy\n    2. An eGFR \\< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.\n    3. Biopsy proven liver cirrhosis.\n    4. Need for chronic renal replacement therapy.\n    5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \\< 30% predicted.\n    6. History of cerebrovascular disease with significant (\\> 80%) uncorrected internal carotid stenosis.\n    7. Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.\n16. Any condition other than HF that could limit survival to less than 24 months.\n17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.","locations":[{"facility":"Banner-University Medical Center Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Baptist Health Medical Center","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Medical Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California at San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shands at the University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Florida","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Heart Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Augusta Hospital","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WellStar Kennestone Hospital","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advocate Health & Hospitals Corporation","city":"Oakbrook Terrace","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Vincent Hospital","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospitals & Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansas University Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky","city":"Lexington","state":"Kentucky","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Norton Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maine Medical Center","city":"Portland","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Health Butterworth Hospital","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis Heart Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Newark Beth Israel Medical Center","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Mexico Heart Institute","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Shore University Hospital","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York-Presbyterian/Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center - Moses Campus","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolinas Medical Center","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integris Baptist Medical Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Heart Institute at Utica","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Francis Hospital","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Abington Memorial Hospital","city":"Abington","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Milton S. Hershey Medical Center","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center (UPMC)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny General Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health Midlands","city":"Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Stern Cardiovascular Foundation","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Texas Cardiovascular","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor University Hospital","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHI St. Luke's Health Baylor College of Medicine Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Memorial Hermann","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Heart Hospital Baylor Plano","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scott & White Memorial Hospital","city":"Temple","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Hospital","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Medical Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Medical Group","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AKH -Wien","city":"Vienna","state":"State of Vienna","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"IKEM Prague","city":"Prague","state":"CBohmia","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet","city":"Copenhagen","state":"Copenhagen","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herzzentrum Leipzig GmbH","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Hochschule Hannover","city":"Hanover","state":"Saxon","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deutsches Herzzentrum der Charité","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O.U. Citta della Salute e della Scienza di Torino","city":"Turin","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus MC - Thoraxcenter","city":"Rotterdam","state":"Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMC Utrecht","city":"Utrecht","state":"Utrecht","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Fahad Medical City","city":"Riyadh","state":"Riyadh Region","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Faisal Specialist Hospital","city":"Riyadh","state":"Riyadh Region","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nourdine Chakouri, PhD","phone":"925-989-5982","email":"nourdine.chakouri@abbott.com"}],"primaryOutcomes":["Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes"],"hasResults":false,"conditionSlugs":["heart-failure","hypertension"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","little-rock-arkansas","sacramento-california","san-francisco-california","washington-d-c-district-of-columbia","gainesville-florida","weston-florida","atlanta-georgia","augusta-georgia","marietta-georgia","chicago-illinois","oakbrook-terrace-illinois","indianapolis-indiana","iowa-city-iowa","kansas-city-kansas","lexington-kentucky","louisville-kentucky","portland-maine","boston-massachusetts","detroit-michigan","grand-rapids-michigan","minneapolis-minnesota","rochester-minnesota","kansas-city-missouri","omaha-nebraska","hackensack-new-jersey","newark-new-jersey","albuquerque-new-mexico","manhasset-new-york","new-york-new-york","rochester-new-york","the-bronx-new-york","chapel-hill-north-carolina","charlotte-north-carolina","cincinnati-ohio","cleveland-ohio","oklahoma-city-oklahoma","tulsa-oklahoma","portland-oregon","abington-pennsylvania","hershey-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","charleston-south-carolina","columbia-south-carolina","memphis-tennessee","austin-texas","dallas-texas","houston-texas","plano-texas","temple-texas","salt-lake-city-utah","charlottesville-virginia","richmond-virginia","milwaukee-wisconsin","vienna-austria","prague-czechia","copenhagen-denmark","leipzig-germany","hanover-germany","berlin-germany","turin-italy","rotterdam-netherlands","utrecht-netherlands","riyadh-saudi-arabia"],"enrichment":{"headline":"Not a traditional drug phase: CardioMEMS HF System for Heart Failure","inPlainEnglish":"The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.","whoItsFor":["Ages 18 Years to any","LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²","Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \\<50% of predicted peak VO2 value)","NYHA Class IIIB or NYHA Class IV","Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months","Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant","Subject is willing and able to be implanted with the HM3 LVAS if randomly assigned to HM3 Group","Randomization Criteria:"],"whoShouldSkip":["Dependent on IV inotrope in the last 30 days","Contra-indications to HM3 LVAS or CardioMEMS HF system","Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy","Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter","Existence of ongoing MCS","Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant","History of any solid organ transplant"],"whatHappens":"If you join, the listed intervention(s) are CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, or Guideline Medical Directed Therapy. The registry lists allocation as randomized. The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are not dependent on intravenous inotrope.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 850 people at 70 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.436Z"},{"nctId":"NCT06528314","title":"A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects With Compensated Cirrhosis Due to 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intervention(s) are Efruxifermin, or Placebo. The registry lists allocation as randomized. This is a multi-center evaluation of efruxifermin (EFX) in a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study in subjects with compensated cirrhosis due to NASH/MASH.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,150 people at 292 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.159Z"},{"nctId":"NCT06529406","title":"Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod","officialTitle":"Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod (COAST: CD20 and Ozanimod Sequencing Trial)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"A multi-center pilot study to evaluate safety and efficacy of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.","conditions":["Relapsing Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ozanimod"}],"enrollment":100,"startDate":"2024-07-29","completionDate":"2028-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit\n* Male or female participants \\> or = to 18 years of age at the time of initiation of de-escalation\n* Participants do not have evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation\n* Participant is taking an anti-CD20 therapy as a DMT continuously for a minimum of two years (e.g., has received at least 3 courses of rituximab, ocrelizumab, ublituximab; 24 months of treatment with ofatumumab; or a combination of treatments whereby the patient has been deemed to be B-cell depleted for 2 years) prior to initiation of de-escalation\n* Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1\n* Participants must provide written informed consent and be able to comply with the visit schedule and study related assessments\n* Participants must be able to undergo a brain MRI without anesthesia\n* Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions.\n\nExclusion Criteria:\n\n* Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS\n* Participant has an EDSS \\>6.5\n* Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)\n* Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening.\n* Participant has any other significant medical or psychiatric illness, if uncontrolled, that could jeopardize a subject's health or put them at significant safety risk during the course of the study in the opinion of treating investigator. Examples: uncontrolled hypertension, uncontrolled diabetes, uncontrolled asthma, uncontrolled depression\n* Participant has a history of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that has been excised and resolved)\n* Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure\n* Participant has Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker\n* Participant has severe untreated sleep apnea\n* Participant has a history of diabetes mellitus type 1, or uncontrolled diabetes mellitus type 2 with hemoglobin A1c (HbA1c) \\> 9%, or is a diabetic subject with significant comorbid conditions such as retinopathy or nephropathy, or a history of uveitis\n* Participant has a history or known presence of recurrent or chronic infection (e.g., hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV); recurrent urinary tract infections are allowed.\n* Any known or suspected active infection (excluding onychomycosis) at screening, including but not limited to a confirmed or suspected progressive multifocal leukoencephalopathy (PML). Known currently active tuberculosis (TB). History of incompletely treated Mycobacterium tuberculosis (TB) infection, as indicated by: Subject's medical records documenting incomplete treatment for Mycobacterium TB; Subject's self-reported history of incomplete treatment for Mycobacterium TB; Subjects with a history of TB who have undergone treatment accepted by the local health authorities (within 1 year from screening) may be eligible for study entry.\n\nExclusions related to Medications:\n\n* Concomitant use of a monoamine oxidase inhibitor\n* Use of systemic corticosteroids in the last 2 years, except for the use as a premedication for B-cell depleting treatment (Note: Use of inhaled or topical steroids; use of oral steroids for no greater than 14 days given for a non-MS condition are allowed)\n* Prior use of alemtuzumab, mitoxantrone, cyclophosphamide, methotrexate, cyclosporine, or any experimental MS treatment within 5 half-lives\n* Prior allergy to ozanimod\n\nExclusions related to Laboratory results:\n\n* Participant has IgG levels \\<400 mg/dL\n* Participant has neutrophils \\< 1500/μL (1.5 GI/L)\n* Participant has an absolute white blood cell (WBC) count \\< 3500/μL (3.5 GI/L)\n* Participant has an absolute lymphocyte count (ALC) \\< 800 cells/μL (0.80 GI/L).\n* Participant has liver function impairment or persisting elevations of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) results \\> 3 x the upper limit of normal (ULN)","locations":[{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Enrique Alvarez, MD/PhD","phone":"303-724-8249","email":"enrique.alvarez@cuanschutz.edu"},{"name":"Lilli Farrell, BS","phone":"","email":"lillian.farrell@cuanschutz.edu"}],"primaryOutcomes":["New T2 lesions count","Serious infections"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["aurora-colorado","las-vegas-nevada","cleveland-ohio"],"enrichment":{"headline":"Phase 4: testing Ozanimod for Relapsing Multiple Sclerosis","inPlainEnglish":"A multi-center pilot study to evaluate safety and how well it works of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.","whoItsFor":["Ages 18 Years to any","Participants have been diagnosed with relapsing forms of MS and have had multiple sclerosis related symptoms at least 3 years prior to baseline visit","Male or female participants \\> or = to 18 years of age at the time of initiation of de-escalation","Participants do not have evidence of new inflammatory disease activity (no new T2/contrast enhancing lesions, absence of relapses) for a minimum of two years prior to de-escalation","Participants received their last anti-CD20 infusion, including ocrelizumab subcutaneous injection, within 6-12 months or received their last ofatumumab injection within 30 -180 days from Day 1","Participants must be able to undergo a brain MRI without anesthesia","Woman of Childbearing Potential must agree to practice a highly effective method of contraception throughout the study until completion and willing to follow pregnancy precautions"],"whoShouldSkip":["Any progression of neurological disability in the year prior to the screening visit that would be consistent with progressive MS","Participant has an EDSS \\>6.5","Participant has a history of other chronic neurological illnesses that might mimic MS with chronic or intermittent symptoms (i.e. ALS, myasthenia gravis, chronic neuropathy, etc.)","Participant is considering pregnancy in the short term, is pregnant, lactating or has a positive serum beta human chorionic gonadotropin (B-hCG) measured during screening","Participant has a history of cancer within the last 5 years, including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin or cervical dysplasia/cancer that has been excised and resolved)","Participant has a history in the last 6 months of myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure","Participant has Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker"],"whatHappens":"If you join, the listed intervention(s) are Ozanimod. The registry lists allocation as randomized. A multi-center pilot study to evaluate safety and how well it works of ozanimod as de-escalation therapy in clinically stable MS patients previously treated with anti-CD20 therapy.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.996Z"},{"nctId":"NCT06529523","title":"Tislelizumab in People With Colorectal Cancer","officialTitle":"PD-1 (Programmed Cell Death Protein 1) Blockade in Mismatch-repair Deficient Colorectal Cancer in Nigeria","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.\n\nAll participants in this study will be treatment naïve (they have not yet received treatment for their cancer), and their cancer will be mismatch repair deficient (dMMR). dMMR cancer can happen when your cells are unable to repair mistakes made during the cell division process.","conditions":["Colorectal Cancer"],"keywords":["Tislelizumab","PD-1 blockade","24-063"],"interventions":[{"type":"DRUG","name":"Tislelizumab"}],"enrollment":40,"startDate":"2024-07-26","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"All subjects\n\nInclusion Criteria:\n\n* Age 18 years or older on date of signing informed consent\n* ECOG performance status of 0 or 1\n* Negative pregnancy test done within 72 hours prior to start of treatment for women of childbearing potential.\n\n  * Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab They must also have a negative urine or serum pregnancy test result ≤ 7 days before first dose of study drug.\n  * The Clinical Trials Facilitation Group recommendations related to contraception and pregnancy testing in clinical studies include the use of highly effective forms of birth control (Clinical Trials Facilitation Group 2014). These methods include the following:\n\n    * Oral, intravaginal, or transdermal combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation\n    * Oral, injectable, implantable progestogen-only hormonal contraception associated with the inhibition of ovulation Note: Oral birth control pills are not considered a highly effective form of birth control, and if they are selected, they must be used with a second, barrier method of contraception such as condoms with or without spermicide.\n    * An intrauterine device\n    * Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomized partner Note: This is only considered a highly effective form of birth control when the vasectomized partner is the sole partner of the study participant and there has been a medical assessment confirming surgical success.\n    * A sterile male is one for whom azoospermia, in a semen sample, has been demonstrated as definitive evidence of infertility.\n    * Sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment) Note: Total sexual abstinence should only be used as a contraceptive method if it is in line with the patients' usual and preferred lifestyle.\n\nPeriodic abstinence (eg, calendar, ovulation, sympto-thermal, postovulation methods), declaration of abstinence for the duration of exposure to study drug, and withdrawal are not acceptable methods of contraception.\n\nOf note, barrier contraception (including male and female condoms with or without spermicide) is not considered a highly effective method of contraception; if used, this method must be used in combination with one of the highly effective forms of birth control listed above.\n\n°\"Women of non-childbearing potential\" are defined as female patients meeting any of the following criteria:\n\n* Surgically sterile (ie, through bilateral salpingectomy, bilateral oophorectomy, or hysterectomy)\n* Postmenopausal, defined as:\n\n  * ≥ 55 years of age with no spontaneous menses for ≥ 12 months OR\n  * \\< 55 years of age with no spontaneous menses for ≥ 12 months AND with postmenopausal follicle-stimulating hormone (FSH) concentration \\> 30 IU/mL and all alternative medical causes for the lack of spontaneous menses for ≥ 12 months have been ruled out, such as polycystic ovarian syndrome, hyperprolactinemia, etc.\n  * If an FSH measurement is required to confirm postmenopausal state, concomitant use of hormonal contraception or hormonal replacement therapy should be excluded.\n\n\\[Adapted from Clinical Trials Facilitation Group (CTFG) 2014.\\]\n\n* Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of tislelizumab\n\n  •A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility.\n  * Males with known \"low sperm counts\" (consistent with \"subfertility\") are not to be considered sterile.\n\n    \\- Demonstration of adequate organ function below within 14 days of cycle 1 day 1\n    * The ability to adhere to the study protocol and willingness to provide informed consent\n    * Cohort 1 subjects\n  * Histological confirmation of colorectal adenocarcinoma\n  * Confirmation of dMMR by immunohistochemistry\n  * Radiologically measurable metastatic disease as per RECIST 1.1, not eligible for potentially curative surgery -Cohort 2 subjects\n  * Histological confirmation of rectal adenocarcinoma\n  * Confirmation of dMMR by immunohistochemistry\n  * Rectal cancer stage II or III per AJCC 8 th edition criteria\n  * No evidence of distant metastases\n\n    * Hematological\n* Absolute neutrophil count (ANC) ≥1,500 /mm\\^3\n* Platelets ≥100,000 / mcL\n* Hemoglobin \\>9 g/dL or ≥5.6 mmol/L\n\n  * Renal\n* Serum creatinine OR measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × upper limit of normal (ULN) OR ≥30 mL/min for subject with creatinine levels \\> 1.5 × institutional ULN\n\n  * Hepatic\n* Serum total bilirubin ≤ 1.5 × ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN\n* AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN (\\< 5 x ULN if hepatic metastases are present in cohort 1\n\n  * Coagulation\n* International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) INR \\<1.5 or PT \\<1.5 x ULN; and either PTT or aPTT \\<1.5 x ULN. Patients on warfarin may be included on a stable dose with a therapeutic INR \\<3.5\n\nExclusion Criteria:\n\n* Presence of other active malignancy\n* Diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days prior to first dose of treatment\n* Any condition that required systemic treatment with either corticosteroids (\\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before first dose of study drug. Inhaled or topical steroids, and adrenal replacement doses \\> 10 mg daily prednisone equivalents are permitted in the absence of an active autoimmune disease. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:\n\n  1. Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)\n  2. Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption\n  3. Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen\n* Active autoimmune disease requiring systemic therapy within the 2 years prior to treatment initiation\n\n  o Well controlled hypothyroidism, diabetes, and skin conditions allowed\n* Untreated active Hepatitis B or Hepatitis C\n\n  o Patients actively on therapy with disease under control are allowed\n* Untreated Acquired Immunodeficiency Syndrome (AIDS)\n\n  o Patients with Human Immunodeficiency Virus (HIV) well controlled on anti-retroviral therapy are allowed\n* Infection (including tuberculosis infection, etc.) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before first dose of study drug\n* History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis.\n\n  o Patients with significantly impaired pulmonary function or who require supplemental oxygen at baseline must undergo an assessment of pulmonary function at screening\n* Currently receiving other anticancer or experimental therapy\n* Has received prior therapy with an immune checkpoint inhibitor\n* Prior ≥ Grade 3 immune-related AE from previous immunotherapy\n* Pregnant women, women who are breast-feeding, or men expecting to conceive or father children during the trial period, through 120 days after last dose of medication\n* Receipt of live vaccine within 30 days of planned treatment start\n* Major surgical procedure or significant traumatic injury within 28 days prior to enrollment\n* Known hypersensitivity to Tislelizumab\n* Prior allogeneic stem cell or organ transplantation\n* Any of the following cardiovascular risk factors:\n\n  a. Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before first dose of study drug b. Pulmonary embolism ≤ 28 days before first dose of study drug c. Any history of acute myocardial infarction ≤ 6 months before first dose of study drug d. Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before first dose of study drug e. Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before first dose of study drug f. Any history of cerebrovascular accident ≤ 6 months before first dose of study drug g. Uncontrolled hypertension that cannot be managed by standard antihypertension medications ≤ 28 days before first dose of study drug h. Any episode of syncope or seizure ≤ 28 days before first dose of study drug\n* Cohort 1 subjects\n* Prior immunotherapy, chemotherapy, radiation therapy, or surgery for metastatic colorectal cancer\n\n  o Treatment with adjuvant therapy of prior localized tumor is allowable as long as it was completed at least 6 months prior to cycle 1 day 1\n* Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis\n\n  o Patients with previously treated brain metastases may participate if the brain metastases are stable via MRI assessment, performed ≥ 4 weeks after treatment\n* Cohort 2 subjects\n* Prior immunotherapy, chemotherapy, radiation therapy, or surgery for localized rectal cancer\n* Presence of metastatic or recurrent disease","locations":[{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lagos University Teaching Hospital","city":"Idi-Araba","state":"Lagos","country":"Nigeria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Obafemi Awolowo University Teaching Hospital","city":"Ile-Ife","state":"","country":"Nigeria","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fiyinfolu O Balogun, MD, PhD","phone":"646-888-6964","email":"balogunf@mskcc.org"},{"name":"Peter Kingham, MD","phone":"212-639-5260","email":""}],"primaryOutcomes":["objective response rate of PD-1 blockade with tislelizumab"],"hasResults":false,"conditionSlugs":["colorectal-cancer","als"],"drugSlugs":[],"locationSlugs":["new-york-new-york","idi-araba-nigeria","ile-ife-nigeria"],"enrichment":{"headline":"Phase 2: testing Tislelizumab for Colorectal Cancer","inPlainEnglish":"The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria. The researchers will also look at the safety of the study drug.","whoItsFor":["Ages 18 Years to any","how well you can do daily activities (ECOG score) of 0 or 1","Negative pregnancy test done within 72 hours prior to start of treatment for women of childbearing potential","The Clinical Trials Facilitation Group recommendations related to contraception and pregnancy testing in clinical studies include the use of highly effective forms of birth control (Clinical Trials Facilitation Group 2014). These methods include the following:","Oral, intravaginal, or transdermal combined (estrogen- and progestogen-containing) hormonal contraception associated with the inhibition of ovulation","An intrauterine device","Intrauterine hormone-releasing system","Bilateral tubal occlusion"],"whoShouldSkip":["Presence of other active malignancy","Diagnosis of immunodeficiency or receiving systemic steroid therapy or other immunosuppressive therapy within 7 days prior to first dose of treatment","Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)","Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption","Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen","Active autoimmune disease requiring systemic therapy within the 2 years prior to treatment initiation","o Well controlled hypothyroidism, diabetes, and skin conditions allowed"],"whatHappens":"If you join, the listed intervention(s) are Tislelizumab. The registry lists allocation as randomized. The researchers are doing this study to find out whether tislelizumab is an effective treatment for people with colorectal cancer who are living in Nigeria.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.072Z"},{"nctId":"NCT06530732","title":"Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)","officialTitle":"Deep Cervical Lymphatlc-Venous Anastomosis Surgery for the Treatment of Alzheimer's Disease: A Pilot Study (DIVA Study)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Zhejiang Provincial People's Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to To demonstrate the Safety and Efficacy of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and exclusion criteria and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone)\n\nParticipants will:\n\nUndergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).\n\nPrimary Outcome Measures: The change in the sum of Clinical Dementia Rating Scale (CDR) scores at 12-month in relative to baseline","conditions":["Alzheimer's Disease"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Deep Cervical lymphatlc-Venous Anastomosis Surgery"},{"type":"DRUG","name":"Lecanemab"}],"enrollment":60,"startDate":"2024-07-01","completionDate":"2026-06-30","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed as an AD patient according to biological markers and clinical symptoms;\n* Over 35 years old and with an MMSE or MOCA score ≤ 26;\n* The patient or family member has signed an informed consent form.\n\nExclusion Criteria:\n\n* Inability to cooperate with lumbar puncture;\n* Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);\n* Significant organ dysfunction (heart, lung, liver, kidney);\n* Coagulation disorders or contraindications to surgery;\n* Inability to fully cooperate with follow-up visits.","locations":[{"facility":"Zhejiang Provincial People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The rate of change in the total score of the Clinical Dementia Rating Scale"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Phase 3: testing Lecanemab for Alzheimer's Disease","inPlainEnglish":"The goal of this clinical trial is to To demonstrate the Safety and how well it works of dcLVA Surgery for the Treatment of Alzheimer's Disease. Patients who meet the inclusion and who cannot join and consent to participate will be randomly assigned to either the experimental group (receiving dcLVA surgery plus standard medication) or the control group (receiving standard medication alone) Participants will: Undergo cognitive assessment and brain MRI assessment; Undergo a lumbar puncture; Undergo an injection of 20ml of gadodiamide contrast agent at a concentration of 0.5 mmol/L (1ml gadodiamide: 20ml 0.9% saline).","whoItsFor":["Diagnosed as an AD patient according to biological markers and clinical symptoms;","Over 35 years old and with an MMSE or MOCA score ≤ 26;"],"whoShouldSkip":["Inability to cooperate with lumbar puncture;","Cognitive impairment due to neurological infections (e.g., HIV, neurosyphilis, autoimmune encephalitis) or systemic diseases (e.g., diabetes, thyroid dysfunction);","Significant organ dysfunction (heart, lung, liver, kidney);","Coagulation disorders or contraindications to surgery;","Inability to fully cooperate with follow-up visits"],"whatHappens":"If you join, the listed intervention(s) are Deep Cervical lymphatlc-Venous Anastomosis Surgery, or Lecanemab. The registry lists allocation as randomized. The goal of this clinical trial is to To demonstrate the Safety and how well it works of dcLVA Surgery for the Treatment of Alzheimer's Disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 60 people at Hangzhou. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.236Z"},{"nctId":"NCT06540833","title":"A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Psychosis Associated With Alzheimer's Disease","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study to Assess the Efficacy, Safety, and Tolerability of ITI 1284 in Patients With Psychosis Associated With Alzheimer's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose study evaluating the efficacy, safety, and tolerability of ITI-1284 compared with placebo in the treatment of psychosis in patients with AD.","conditions":["Psychotic Disorders","Alzheimer Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITI-1284"},{"type":"DRUG","name":"Placebo"}],"enrollment":370,"startDate":"2024-08-15","completionDate":"2028-09-30","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations\n2. Meets clinical criteria for AD based on 2011 NIA-AA criteria and either:\n\n   1. Has a high likelihood for amyloid pathology consistent with AD, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or\n   2. Has documented confirmation of AD by cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan\n3. Meets criteria for psychosis in accordance with the International Psychogeriatric Association (IPA) provisional consensus definition at Screening and Baseline\n4. Scoring ≥ 2 on any item of the BEHAVE-AD Part A. Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline\n5. CGI-S score ≥ 4 at Screening and Baseline\n6. Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures\n7. Has a designated caregiver (eg, relative, housemate, close personal friend, or professional caregiver)\n\nExclusion Criteria:\n\n1. Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (for example, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:\n\n   1. Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia\n   2. Bipolar disorder\n2. Risk for suicidal behavior during the course of their participation in the study or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by C-SSRS; or the patient has had 1 or more suicide attempts within 2 years prior to Screening\n3. The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee\n4. The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia\n5. The patient is bedridden or has any significant medical condition that is unstable and would either:\n\n   1. Place the patient at undue risk from study drug or undergoing study procedures; or\n   2. Interfere with the interpretation of safety or efficacy evaluations performed during the course of the study\n6. 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Paranoid and Delusional Ideation item and/or Part B. Hallucinations item (ie, psychosis subscale) at Screening and Baseline","CGI-S score ≥ 4 at Screening and Baseline","Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 (inclusive) at Screening with sufficient verbal ability to understand and answer questions and comply with procedures"],"whoShouldSkip":["Psychotic symptoms that are primarily attributable to delirium, substance abuse, or another general-medical condition (for example, hypothyroidism) or has been diagnosed with one or more of the following psychiatric conditions:","Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia","The patient is unable or unwilling to discontinue other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system effects, as reviewed by the Sponsor or designee","The patient is hospitalized or receiving skilled nursing care for any medical condition other than dementia","The patient is bedridden or has any significant medical condition that is unstable and would either:","Place the patient at undue risk from study drug or undergoing study procedures; or","Interfere with the interpretation of safety or how well it works evaluations performed during the course of the study"],"whatHappens":"If you join, the listed intervention(s) are ITI-1284, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, compared with a dummy treatment, flexible-dose study evaluating the how well it works, safety, and tolerability of ITI-1284 compared with dummy treatment (placebo) in the treatment of psychosis in patients with AD.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 370 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.333Z"},{"nctId":"NCT06541704","title":"A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","officialTitle":"A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)","conditions":["Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)"],"keywords":["GA secondary to AMD"],"interventions":[{"type":"DRUG","name":"Pozelimab"},{"type":"DRUG","name":"Cemdisiran"},{"type":"DRUG","name":"Placebo"}],"enrollment":975,"startDate":"2024-10-30","completionDate":"2028-07-31","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply","locations":[{"facility":"Barnet Dulaney Perkins Eye Center-Ophthamalogy","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barnet Dulaney Perkins Eye Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associated Retina Consultants","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Research Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Macula Institute of Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of 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IIS Aragon","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miguel Servet University Hospital","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liverpool University Hospitals NHS Foundation Trust-Royal Liverpool University Hospital, St Paul's Eye Unit-Ophthalmology","city":"Liverpool","state":"Merseyside","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"York and Scarborough Teaching Hospitals NHS Foundation Trust","city":"York","state":"North Yorkshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Bristol NHS Foundation Trust","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moorfields Eye Hospital NHS Foundation Trust, Moorfields Eye Hospital","city":"London","state":"","country":"United 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(FAF)"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["chandler-arizona","phoenix-arizona","scottsdale-arizona","tucson-arizona","springdale-arkansas","beverly-hills-california","encino-california","fresno-california","fullerton-california","huntington-beach-california","irvine-california","la-jolla-california","long-beach-california","los-angeles-california","modesto-california","mountain-view-california","oxnard-california","palm-desert-california","pasadena-california","poway-california","redlands-california","riverside-california","rowland-heights-california","sacramento-california","san-francisco-california","santa-ana-california","torrance-california","aurora-colorado","colorado-springs-colorado","denver-colorado","durango-colorado","lakewood-colorado","longmont-colorado","manchester-connecticut","waterford-connecticut","bonita-springs-florida","coral-springs-florida","fort-lauderdale-florida","fort-myers-florida","hudson-florida","jacksonville-florida","lakeland-florida","naples-florida","orlando-florida","palm-beach-gardens-florida","pinellas-park-florida","sarasota-florida","st-petersburg-florida","tampa-florida","winter-haven-florida","augusta-georgia","marietta-georgia","chicago-illinois","lemont-illinois","oak-park-illinois","springfield-illinois","carmel-indiana","lenexa-kansas","louisville-kentucky","metairie-louisiana","new-orleans-louisiana","west-monroe-louisiana","baltimore-maryland","chevy-chase-maryland","hagerstown-maryland","boston-massachusetts","springfield-massachusetts","waltham-massachusetts","worcester-massachusetts","grand-blanc-michigan","madison-mississippi","southaven-mississippi","st-louis-missouri","nashua-new-hampshire","cherry-hill-new-jersey","teaneck-new-jersey","toms-river-new-jersey","albuquerque-new-mexico","brentwood-new-york","liverpool-new-york","new-york-new-york","poughkeepsie-new-york","asheville-north-carolina","cary-north-carolina","hickory-north-carolina","wake-forest-north-carolina","winston-salem-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","dublin-ohio","edmond-oklahoma","tulsa-oklahoma","eugene-oregon","portland-oregon","springfield-oregon","bethlehem-pennsylvania","erie-pennsylvania","philadelphia-pennsylvania","sewickley-pennsylvania","greenville-south-carolina","ladson-south-carolina","mt-pleasant-south-carolina","west-columbia-south-carolina","rapid-city-south-dakota","sioux-falls-south-dakota","nashville-tennessee","abilene-texas","austin-texas","bellaire-texas","dallas-texas","fort-worth-texas","katy-texas","mcallen-texas","plano-texas","round-rock-texas","san-antonio-texas","southlake-texas","the-woodlands-texas","tyler-texas","salt-lake-city-utah","west-jordan-utah","burlington-vermont","bristol-virginia","fairfax-virginia","lynchburg-virginia","richmond-virginia","spokane-washington","morgantown-west-virginia","albury-australia","hurstville-australia","strathfield-australia","adelaide-australia","east-melbourne-australia","graz-austria","vienna-austria","ottawa-canada","qu-bec-canada","nice-france","marseille-france","poitiers-france","toulouse-france","cr-teil-france","dijon-france","lille-france","lyon-france","nantes-france","paris-france","rouen-france","ulm-germany","berlin-germany","frankfurt-am-main-germany","marburg-germany","g-ttingen-germany","neubrandenburg-germany","bonn-germany","d-sseldorf-germany","m-nster-germany","ludwigshafen-am-rhein-germany","homburg-germany","sulzbach-germany","hamburg-germany","mainz-germany","w-rzburg-germany","p-cs-hungary","szeged-hungary","debrecen-hungary","budapest-hungary","rome-italy","milan-italy","florence-italy","ancona-italy","bydgoszcz-poland","tarnowskie-g-ry-poland","olsztyn-poland","c-rdoba-spain","lhospitalet-de-llobregat-spain","terrassa-spain","burjassot-spain","barcelona-spain","seville-spain","valencia-spain","zaragoza-spain","liverpool-united-kingdom","york-united-kingdom","bristol-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Pozelimab for Age-related Macular Degeneration (AMD)","inPlainEnglish":"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD).","whoItsFor":["Ages 50 Years to 85 Years","Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol","Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol","BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol","Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol","Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol"],"whoShouldSkip":["GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy","History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol","Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization","Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization","Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study","Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol"],"whatHappens":"If you join, the listed intervention(s) are Pozelimab, Cemdisiran, or Placebo. The registry lists allocation as randomized. This study is researching experimental (study) drugs called pozelimab and cemdisiran.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 975 people at 233 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.140Z"},{"nctId":"NCT06543550","title":"Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis","officialTitle":"Comparison Between the Effects of Implantable Gestrinone and Oral Dienogest in the Treatment of Endometriosis: Randomized Controlled Clinical Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Bio Meds Pharmaceutica Ltda","sponsorClass":"INDUSTRY","summary":"This study aims to evaluate the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.","conditions":["Endometriosis"],"keywords":["Endometriosis","Implantable Gestrinone","Dienogest"],"interventions":[{"type":"DRUG","name":"Implantable gestrinone"},{"type":"DRUG","name":"Oral Dienogest"}],"enrollment":70,"startDate":"2024-07-30","completionDate":"2027-03","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them.\n* Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation)14, have a BMI of up to 25kg/m2, and weigh between 50 and 70kg.\n\nExclusion Criteria:\n\n* Pregnant patients (supporting test must be presented)\n* Breastfeeding women, using other hormonal contraceptive methods or copper or silver IUDs, who have polycystic ovaries, and/or hyperandrogenism.\n* Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study.\n* Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure\n* Patient who are scheduled for surgical treatment during the study period.","locations":[{"facility":"Instituto Longevite Servicos Medicos LTDA","city":"Campina Grande","state":"Paraíba","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nutrindo Ideiais Rio de Janeiro","city":"Rio de Janeiro","state":"Rio de Janeiro","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jpml Clinica Medica LTDA","city":"São José dos Campos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nutrindo Ideiais São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"André V. A. Florentino, Dr","phone":"+55 83 982001868","email":"f.andrevinicius@gmail.com"}],"primaryOutcomes":["Evaluation of dysmenorrhea severity","Evaluation of dyspareunia severity","Evaluation of non-cyclical pelvic pain severity","Evaluation of endometriosis foci regression"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["campina-grande-brazil","rio-de-janeiro-brazil","s-o-jos-dos-campos-brazil","s-o-paulo-brazil"],"enrichment":{"headline":"Phase 4: testing Implantable gestrinone for Endometriosis","inPlainEnglish":"This study aims to measure the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Adult female patients of menstrual age, pre-menopause (18 to 45 years old), who seek medical treatment to alleviate complaints related to endometriosis, who are not undergoing other therapies to treat them","Patients must have a diagnosis of Grade 1 or 2 endometriosis assessed by imaging tests (ultrasound with bowel preparation and/or MRI of the pelvis with bowel preparation)14, have a body-mass index (BMI) of up to 25kg/m2, and weigh between 50 and 70kg"],"whoShouldSkip":["Pregnant patients (supporting test must be presented)","Breastfeeding women, using other hormonal contraceptive methods or copper or silver IUDs, who have polycystic ovaries, and/or hyperandrogenism","Patients using medications that may interfere with androgen metabolism within 4 weeks of screening or during the study","Patients with a history of liver disease, cardiovascular disease (myocardial infarction, unstable angina or heart failure), active hepatitis, liver neoplasia or renal failure","Patient who are scheduled for surgical treatment during the study period"],"whatHappens":"If you join, the listed intervention(s) are Implantable gestrinone, or Oral Dienogest. The registry lists allocation as randomized. This study aims to measure the effects of therapy with implantable Gestrinone compared to oral Dienogest in relieving complaints related to endometriosis.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 70 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.110Z"},{"nctId":"NCT06545474","title":"Effects of rTMS Compared to SSRI as Early Treatment of Depression (Early-TMS)","officialTitle":"Repetitive Transcranial Magnetic Stimulation (rTMS) as an Early Intervention in Major Depression (MD) Compared to Antidepressant Selective Serotonin Reuptake Inhibitor (SSRI) Medication (Early-TMS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Hospital Tuebingen","sponsorClass":"OTHER","summary":"The aim of this randomized multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression. In this two-stage, therapy response-adapted trial, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomized in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication. The allocation to Stage II occurs therapy response-adapted. Patients receive either a maintenance treatment or a switch to the respective other treatment arm. The primary outcome is the comparison of the two study arms with regard to therapy response measured with the Montgomery-Asberg Depression Rating Scale (MADRS) after 4 weeks at the end of Stage I.","conditions":["Major Depressive Disorder"],"keywords":["Depression","non-invasive brain stimulation","repetitive transcranial magnetic stimulation","theta burst stimulation","non-treatment resistant depression"],"interventions":[{"type":"DEVICE","name":"bilateral theta burst stimulation"},{"type":"DRUG","name":"SSRI treatment"}],"enrollment":106,"startDate":"2024-09-15","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* male, female, or diverse gender;\n* age between 18 and 65 years;\n* moderate to severe MD according to the diagnostic criteria of DSM-5;\n* MADRS Score ≥ 20 points;\n* the duration of the episode must be at least 2 weeks and not exceed a period of 2 years;\n* no previous antidepressant treatment; indication for antidepressant medication;\n* patients must be capable of giving informed consent.\n\nExclusion Criteria:\n\n* acute suicidal ideation (MADRS item 10 score \\> 4);\n* presence of psychotic symptoms;\n* antiepileptic drugs or benzodiazepines in a dosage equivalent to \\> 1 mg Lorazepam/d;\n* comorbid Axis I disorder (except anxiety disorders and ADHD);\n* presence of severe, clinically relevant, and predominant comorbid personality disorder;\n* treatment resistance defined as the failure of at least one adequate antidepressant treatment attempt in the current or previous depressive episode;\n* neurological pre-existing conditions such as severe traumatic brain injury, neoplasms, brain surgery, stroke within the last 3 months, neurodegenerative diseases: epilepsy or history of epileptic seizures;\n* cardiac pacemaker (not compatible with MRI);\n* intracranial metallic implants;\n* previous rTMS treatment;\n* deep brain stimulation;\n* other severe somatic diseases; pregnancy;\n* contraindications for the use of escitalopram.","locations":[{"facility":"University Hospital Tuebingen","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christian Plewnia, Prof. Dr.","phone":"+4970712984858","email":"christian.plewnia@med.uni-tuebingen.de"},{"name":"Julia Becker-Sadzio, Dr.","phone":"+4970712984858","email":"julia.becker-sadzio@med.uni-tuebingen.de"}],"primaryOutcomes":["response rates after Stage I"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["t-bingen-germany"],"enrichment":{"headline":"Not a traditional drug phase: testing SSRI treatment for Major Depressive Disorder","inPlainEnglish":"The aim of this randomly assigned multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression. In this two-stage, therapy response-adapted trial, 106 patients suffering from non-treatment resistant major depression (non-TR MD) will be randomly assigned in Stage I to either 4 weeks bilateral theta burst stimulation (TBS) or 4 weeks antidepressant SSRI medication.","whoItsFor":["Ages 18 Years to 65 Years","male, female, or diverse gender;","age between 18 and 65 years;","moderate to severe MD according to the diagnostic criteria of DSM-5;","MADRS Score ≥ 20 points;","the duration of the episode must be at least 2 weeks and not exceed a period of 2 years;","no previous antidepressant treatment; indication for antidepressant medication;"],"whoShouldSkip":["acute suicidal ideation (MADRS item 10 score \\> 4);","presence of psychotic symptoms;","antiepileptic drugs or benzodiazepines in a dosage equivalent to \\> 1 mg Lorazepam/d;","comorbid Axis I disorder (except anxiety disorders and ADHD);","presence of severe, clinically relevant, and predominant comorbid personality disorder;","treatment resistance defined as the failure of at least one adequate antidepressant treatment attempt in the current or previous depressive episode;","neurological pre-existing conditions such as severe traumatic brain injury, neoplasms, brain surgery, stroke within the last 3 months, neurodegenerative diseases: epilepsy or history of epileptic seizures;"],"whatHappens":"If you join, the listed intervention(s) are bilateral theta burst stimulation, or SSRI treatment. The registry lists allocation as randomized. The aim of this randomly assigned multicentre phase 2 clinical trial is to compare the effects of rTMS and SSRI medication as early treatment of depression.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 106 people at Tübingen. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.100Z"},{"nctId":"NCT06546670","title":"A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease","officialTitle":"A Phase I/II Clinical Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ITU512 in Healthy Participants and Patients With Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).","conditions":["Sickle Cell Disease"],"keywords":["ITU512","Low molecular weight","Small molecule","Sickle cell disease"],"interventions":[{"type":"DRUG","name":"ITU512"},{"type":"DRUG","name":"Placebo"}],"enrollment":161,"startDate":"2024-08-15","completionDate":"2028-05-01","sex":"ALL","minAge":"12 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Key Inclusion Criteria:\n\nPart 1 (Healthy participants)\n\n* Healthy male participants and female participants of non-childbearing potential between 18-55 years of age\n* In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests\n* Participants must weigh at least 50 kg at screening and first baseline (admission) and must have a body mass index (BMI) within the range of 18.0-32.0 kg/m2 inclusive.\n\nPart 2 (Sickle Cell Disease)\n\n\\- Male and female participants with a diagnosis of sickle cell disease\n\nKey Exclusion Criteria:\n\nPart 1 (Healthy participants)\n\n* QTcF ≥ 450 msec (as a mean value of triplicates)\n* History of arrhythmias\n* History of significant illness which has not resolved within two (2) weeks prior to initial dosing\n* Women of child-bearing potential (WOCBP)\n\nPart 2 (Sickle Cell Disease)\n\n* Current use of hydroxyurea/hydroxycarbamide (HU/HC)\n* QTcF ≥ 450 msec (as a mean value of triplicates)\n* History of arrhythmias\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"University of Alabama Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quotient Sciences Sea View","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Boston Childrens Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School Of Med At Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Cancer Insitute Carolinas Healthcare System","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hospital Of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lifespan","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Health Science Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ankara","state":"Sihhiye Altindag","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Adana","state":"Yuregir","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Part 1A, Part 1B, Part 1C: Incidence of AEs and SAEs","Part 1A, Part 1B , Part 1C: Dose discontinued due to AE","Part 2A, Part 2B: Incidence of AEs and SAEs","Part 2A, Part 2B: Dose interruptions and reductions","Part 2A, Part 2B: Dose intensity","Part 2B: Fetal hemoglobin (HbF)%"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","miami-florida","boston-massachusetts","new-york-new-york","charlotte-north-carolina","greenville-north-carolina","philadelphia-pennsylvania","providence-rhode-island","houston-texas","ribeir-o-preto-brazil","s-o-paulo-brazil","ankara-turkey-t-rkiye","adana-turkey-t-rkiye"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ITU512 for Sickle Cell Disease","inPlainEnglish":"This study wants to measure the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512. This will be the first evaluation of the potential therapeutic effect of ITU512 in healthy participants and patients with sickle cell disease (SCD).","whoItsFor":["Ages 12 Years to 55 Years","Part 1 (Healthy participants)","Healthy male participants and female participants of non-childbearing potential between 18-55 years of age","In good health as determined by the investigator's assessment of medical history, physical examination, vital signs, ECG, and laboratory tests","Participants must weigh at least 50 kg at screening and first baseline (admission) and must have a body mass index (body-mass index (BMI)) within the range of 18.0-32.0 kg/m2 inclusive","Part 2 (Sickle Cell Disease)","\\- Male and female participants with a diagnosis of sickle cell disease"],"whoShouldSkip":["Part 1 (Healthy participants)","QTcF ≥ 450 msec (as a mean value of triplicates)","History of arrhythmias","History of significant illness which has not resolved within two (2) weeks prior to initial dosing","Women of child-bearing potential (WOCBP)","Part 2 (Sickle Cell Disease)","Current use of hydroxyurea/hydroxycarbamide (HU/HC)"],"whatHappens":"If you join, the listed intervention(s) are ITU512, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 161 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.836Z"},{"nctId":"NCT06547788","title":"LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY","officialTitle":"LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Ottawa Heart Institute Research Corporation","sponsorClass":"OTHER","summary":"Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. When left untreated, it may cause death. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers. Our study focuses on patients with primary MR.\n\nThe standard treatment for severe symptomatic primary MR is mitral valve surgery, a type of open-heart surgery. The outcomes following this procedure are excellent, however, a subset of patients continue to experience heart failure symptoms after surgery due to very high pressures in the heart, more specifically in the left atrium, which is one of the four heart chambers. This is called functional mitral stenosis (FMS).\n\nPrevious studies have shown that creating a small opening between the left and right atria can help relieve the pressure inside the left atrium. We would like to determine whether creating this opening between the two atria at the time of mitral valve surgery can help prevent FMS. To answer this question, we will study two groups of patients who need mitral valve surgery for primary MR. The first group will undergo mitral valve surgery, along with the creation of the opening between the two atria. The second group will undergo mitral valve surgery alone. We will then compare the outcomes between both groups, namely with regards to their heart failure symptoms after open-heart surgery.","conditions":["Mitral Regurgitation","Mitral Valve Disease","Heart Failure"],"keywords":[],"interventions":[{"type":"OTHER","name":"Mitral valve repair with creation of an 8 mm inter-atrial shunt"}],"enrollment":50,"startDate":"2024-12-19","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients ≥18 years of age\n* Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease\n* Planned surgical mitral valve repair\n* Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline\n* Pulmonary vascular resistance ≤ 4 Wood units\n\nExclusion Criteria:\n\n* Secondary causes of MR and mixed mitral valve disease\n* Infective endocarditis within 30-days\n* Any prior mitral valve intervention\n* Need for emergency intervention or surgery\n* Left ventricular ejection fraction 2+","locations":[{"facility":"University of Ottawa Heart Institute","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kenza Rahmouni El Idrissi, Dr.","phone":"613-696-7000","email":"krahmouni@ottawaheart.ca"},{"name":"Nahya Awada","phone":"613-696-7230","email":"naawada@ottawaheart.ca"}],"primaryOutcomes":["Feasibility: recruitment rate","Feasibility: Success rate of intervention","Feasibility: Study follow-up rate and length"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["ottawa-canada"],"enrichment":{"headline":"Not a traditional drug phase: Mitral valve repair with creation of an 8 mm inter-atrial shunt for Mitral Regurgitation","inPlainEnglish":"Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate. Patients with MR can be divided in two broad groups: those with primary MR, caused by disease of the mitral valve structures, and those with secondary MR, due to dilation of the heart chambers.","whoItsFor":["Ages 18 Years to any","Patients ≥18 years of age","Severe (4+) symptomatic Carpentier Type II MR due to degenerative disease","Planned surgical mitral valve repair","Right-to-left atrial pressure gradient ≥ 5 mmHg at baseline","Pulmonary vascular resistance ≤ 4 Wood units"],"whoShouldSkip":["Secondary causes of MR and mixed mitral valve disease","Infective endocarditis within 30-days","Any prior mitral valve intervention","Need for emergency intervention or surgery","Left ventricular ejection fraction 2+"],"whatHappens":"If you join, the listed intervention(s) are Mitral valve repair with creation of an 8 mm inter-atrial shunt. The registry lists allocation as randomized. Mitral valve leakage, or mitral regurgitation (MR), is associated with heart failure symptoms including shortness of breath, fatigue, irregular heart rate.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Ottawa. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.434Z"},{"nctId":"NCT06548542","title":"Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease","officialTitle":"A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.\n\nThe medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 590 participants will be enrolled in the study at approximately 300 sites worldwide.\n\nRisankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.","conditions":["Crohn's Disease"],"keywords":["Crohn's Disease","Risankizumab","Trosunilimab","Lutikizumab","ABBV-8736"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Lutikizumab"},{"type":"DRUG","name":"Trosunilimab"},{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Trosunilimab"},{"type":"DRUG","name":"ABBV-8736"}],"enrollment":590,"startDate":"2024-09-04","completionDate":"2030-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants' body weight must be \\>= 40 kg at Baseline.\n* Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.\n* CDAI \\>= 220 at Baseline.\n* Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \\>= 6 for ileocolonic or colonic disease or SES-CD of \\>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.\n* Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules.\n\nExclusion Criteria:\n\n* Participant with history of intolerance to p19 inhibitors, including risankizumab.\n* Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.","locations":[{"facility":"Digestive Health Specialists /ID# 266216","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East View Medical Research /ID# 270377","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Res. Ctr /ID# 265549","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health System /ID# 265565","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"uc davis medical center - patient support services building /ID# 265554","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391","city":"San Diego","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Danbury Hospital, Western Connecticut Health Network /ID# 265556","city":"Danbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine /ID# 266786","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novum Research /ID# 278128","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida College of Medicine /ID# 266930","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nature Coast Clinical Research - Inverness /ID# 265874","city":"Inverness","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Medical Research /ID# 266207","city":"Margate","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"A Plus Research /ID# 265878","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanchez Clinical Research /ID# 265887","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute, Inc /ID# 265548","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hillcrest Medical Research, LLC /ID# 267237","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endoscopic Research, Inc. /ID# 267211","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gcp Clinical Research /ID# 278126","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Medical Group - Tampa - Bruce B Downs Boulevard /ID# 265538","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Medical Clinic - Zephyrhills /ID# 267392","city":"Zephyrhills","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Central Georgia /ID# 265547","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Treasure Valley Medical Research /ID# 267114","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center /ID# 267400","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF St. Francis Medical Center /ID# 266973","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic Main Campus /ID# 267434","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health University Hospital /ID# 278129","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky Chandler Medical Center /ID# 265564","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolitan Gastroenterology Group - Chevy Chase /ID# 265877","city":"Chevy Chase","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Rockville /ID# 267712","city":"Rockville","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lucida Clinical Trials /ID# 266548","city":"New Bedford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Columbus /ID# 266503","city":"Novi","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic-Rochester /ID# 265550","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Associates Research, LLC /ID# 267433","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bvl Research /ID# 265870","city":"Liberty","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University /ID# 266938","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vector Clinical Trials /ID# 265561","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nyu Langone Long Island Clinical Research Associates - Lake Success /ID# 265566","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai /ID# 266857","city":"New York","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Northwell Health-Lenox Hill Hospital /ID# 265527","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Yonkers /ID# 266781","city":"Yonkers","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive Health Partners - Biltmore Office /ID# 265539","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati /ID# 265589","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University /ID# 265577","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive Disease Specialists - Oklahoma /ID# 265901","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Health Milton South Hershey Medical Center /ID# 267126","city":"Hershey","state":"Pennsylvania","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Pennsylvania - Perelman Center for Advanced Medicine /ID# 265904","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Orangeburg /ID# 267548","city":"Orangeburg","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI associates of Northeast Tennessee /ID# 265567","city":"Johnson City","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gi Alliance - Cedar Park /ID# 268153","city":"Cedar Park","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proactive Clinical Research /ID# 267305","city":"El Paso","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Digestive Health Associates of Texas (DHAT) Research Institute - 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2: testing Risankizumab for Crohn's Disease","inPlainEnglish":"Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss.","whoItsFor":["Ages 18 Years to 75 Years","Participants' body weight must be \\>= 40 kg at Baseline","Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available","CDAI \\>= 220 at Baseline","Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \\>= 6 for ileocolonic or colonic disease or SES-CD of \\>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader","Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and/or TaTs. TaTs include biologics and/or targeted small molecules"],"whoShouldSkip":["Participant with history of intolerance to p19 inhibitors, including risankizumab"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab, Lutikizumab, or Trosunilimab. The registry lists allocation as randomized. Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 590 people at 255 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.577Z"},{"nctId":"NCT06551909","title":"Radioimmunotherapy in Solid Tumors (PNRR-MCNT2-2023-12378239-Aim2)","officialTitle":"Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"IRCCS San Raffaele","sponsorClass":"OTHER","summary":"This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2). It is based on the results of ongoing studies at our Institute to validate the efficacy of extremely hypofractionated RT in neoadjuvant settings, which observed immunostimulatory effects of RT and the synergy with immune components. The collaboration between San Raffaele Hospital (Milan), the IRCCS Istituto Nazionale dei Tumori Fondazione G. Pascale (Naples) and the San Giuseppe Moscati Hospital of National Relief and High Specialty (Avellino) will ensure that patient recruitment, treatment and monitoring can be translated into facilities of the National Health System using common procedures. The various departments involved will treat patients with the same methods synergistically exploring the immuno/biological factors related to efficacy (and/or toxicity), based on new radioimmunotherapeutic approaches. Clinical and research activity will be developed jointly, drawing on the expertise in radiotherapy, radiomics, oncology, imaging and immunotherapy skills already available.","conditions":["Glioblastoma"],"keywords":["Glioblastoma","Neodjuvant Radiotherapy","Ultrahypofractionated Radiotherapy","Stereotactic Radiotherapy (SRT)","Simultaneous Integrated Boost (SIB)","Image Guidance"],"interventions":[{"type":"RADIATION","name":"Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost"}],"enrollment":30,"startDate":"2024-08-31","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of Glioblastoma.\n* ECOG performance score 0-2 (defined during the first visit)\n* Surgically removable lesion (according to the operability criteria established by the Neurosurgery Unit)\n\nFor healthy volunteers, people who are as comparable as possible with the patient population in terms of sex and age will be recruited\n\nExclusion Criteria:\n\n* Previous stroke\n* Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor","locations":[{"facility":"IRCCS San Raffaele Scientific Institute","city":"Milan","state":"MI","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nadia G Di Muzio, Prof","phone":"+390226437643","email":"dimuzio.nadia@hsr.it"},{"name":"Andrei Fodor, MD","phone":"+390226437634","email":"fodor.andrei@hsr.it"}],"primaryOutcomes":["Acute toxicity"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost for Glioblastoma","inPlainEnglish":"This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2). It is based on the results of ongoing studies at our Institute to validate the how well it works of extremely hypofractionated RT in neoadjuvant settings, which observed immunostimulatory effects of RT and the synergy with immune components.","whoItsFor":["Ages 18 Years to 80 Years","Diagnosis of Glioblastoma","ECOG performance score 0-2 (defined during the first visit)","Surgically removable lesion (according to the operability criteria established by the Neurosurgery Unit)","For healthy volunteers, people who are as comparable as possible with the patient population in terms of sex and age will be recruited"],"whoShouldSkip":["Presence of another primary and/or metastatic tumor For healthy volunteers also, absence of primary and/or metastatic tumor"],"whatHappens":"If you join, the listed intervention(s) are Neoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost. The registry lists allocation as na. This is a prospective multicenter study of hypofractionated radiotherapy for the radiation treatment (RT) of solid tumors and in particular for Glioblastoma (in Aim 2).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Milan. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.488Z"},{"nctId":"NCT06559241","title":"Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy（RECAST-MT）","officialTitle":"Safety and Efficacy of Remote Ischemic Conditioning for Acute Ischemic Stroke Treated With Mechanical Thrombectomy (RECAST-MT): A Multicenter, Randomized, Controlled, Open-label, Blinded Endpoint Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Capital Medical University","sponsorClass":"OTHER","summary":"For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized. However, less than 50% of patients could achieve functional independence, and over 15% died 90 days after stroke. Although the mismatch of successful recanalization with poor prognosis can be attributed to many factors, the infarct core formed during thrombectomy and reperfusion injury after thrombectomy may be among the most important and effective neuroprotective strategies urgently needed.\n\nRemote ischemic conditioning (RIC) is a noninvasive strategy in which one or more cycles of brief and transient limb ischemia confer protection against prolonged and severe ischemia in distant organs. In the transient focal cerebral ischemia-reperfusion model, the application of remote ischemic conditioning before reperfusion or both before and after reperfusion reduces reperfusion injuries and the final infarct size. Because patients with acute ischemic stroke who are treated with endovascular thrombectomy can achieve a high rate of recanalization after focal ischemia, this patient population is akin to the model of transient focal cerebral ischemia-reperfusion. Furthermore, a pilot study has determined the safety and feasibility of remote ischemic conditioning in patients undergoing endovascular thrombectomy. However, whether remote ischemic conditioning could provide clinical benefits to patients with acute ischemic stroke who are treated with endovascular thrombectomy urgently needs investigations.\n\nThis study aims to investigate the safety and efficacy of remote ischemic conditioning in improving functional outcomes of patients with acute ischemic stroke treated with endovascular thrombectomy and explore the effect of treatment duration on the treatment outcome of remote ischemic conditioning.","conditions":["Acute Ischemic Stroke","Anterior Circulation Brain Infarction"],"keywords":["Endovascular thrombectomy","Cerebroprotection","Remote ischemic conditioning"],"interventions":[{"type":"DEVICE","name":"14-day remote ischemic conditioning"},{"type":"DEVICE","name":"30-day remote ischemic conditioning"},{"type":"PROCEDURE","name":"Endovascular thrombectomy"},{"type":"DRUG","name":"Best medical management"}],"enrollment":2105,"startDate":"2024-09-23","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age≥18 years；\n2. Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization;\n3. Large vessel occlusion confirmed by computed tomography angiography (CTA) or magnetic resonance angiography (MRA), including the occlusion of the intracranial segment of the internal carotid artery (ICA) and M1 segment of the middle cerebral artery (MCA), is the cause of symptoms, and mechanical thrombectomy is planned within 24 hours from the time last known well;\n4. Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;\n5. Patients or family members signed a written informed consent form.\n\nExclusion Criteria:\n\n1. Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation);\n2. Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment;\n3. Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;\n4. Coma or lethargy patients (consciousness level score ≥2 in NIHSS);\n5. Unable to obtain an accurate baseline NIHSS score;\n6. Pre-stroke modified Rankin Scale (mRS) score \\>1;\n7. Baseline ASPECTS score ≤5;\n8. Presence of bleeding tendency, deficiency of coagulation factors, or oral anticoagulant therapy with INR \\> 3.0;\n9. Baseline blood glucose \\<2.7mmol/L or \\>22.2mmol/L;\n10. Baseline platelet count \\< 30\\*10\\^9/L;\n11. Severe known renal impairment defined as requiring dialysis (hemodialysis or peritoneal dialysis), or if known creatinine clearance rate \\<30mL/min;\n12. Cranial CT or MRI shows intracranial hemorrhage;\n13. Cranial CT or MRI shows midline deviation and significant occupying effect;\n14. Clinical history, previous imaging examinations, or clinical judgment suggesting intracranial tumors, arteriovenous malformations, or intracranial arterial dissection;\n15. History of head injury in the past 3 months;\n16. History of life-threatening allergy to contrast agents, nickel, titanium metal, or their alloys;\n17. Pregnancy, if women of childbearing age have a positive urinary or serum β-human chorionic gonadotropin (β-hCG) test or are breastfeeding；\n18. The life expectancy of patients is less than 6 months, and they cannot be evaluated within 3 months;\n19. Limb deformity, soft tissue injury, or other conditions that affect the implementation of distant ischemia adaptation therapy;\n20. Participating in other ongoing clinical trials;\n21. Other conditions that the investigators believe are not suitable for participation in this study.","locations":[{"facility":"Suzhou Municipal Hospital of Anhui Province","city":"Suzhou","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taihe County People's Hospital","city":"Taihe Chengguanzhen","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tongling People's Hospital","city":"Tongling","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Luhe Hospital affiliated to Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Fangshan District First Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Provincial Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhangzhou Municipal Hospital of Fujian Province","city":"Zhangzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heyuan People's Hospital","city":"Heyuan","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huizhou Third People's Hospital","city":"Huizhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Second People's Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"South China Hospital Affiliated to Shenzhen University","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Nanning People's Hospital","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qinzhou Second People's Hospital","city":"Qinzhou","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Hainan Medical University","city":"Haikou","state":"Hainan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cangzhou Central Hospital","city":"Cangzhou","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Army Medical University Noncommissioned Officer School Affiliated Hospital","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kailuan General Hospital","city":"Tangshan","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Harbin Medical University","city":"Harbin","state":"Heilongjiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Hongda Hospital of Jiamusi University","city":"Jiamusi","state":"Heilongjiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xunxian People's Hospital","city":"Hebi","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiaozuo Coal Industry Group Co., Ltd. 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Hubei Province","city":"Wuhan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xiangyang Central Hospital","city":"Xiangyang","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yichang Central People's Hospital","city":"Yichang","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changde First Hospital of Traditional Chinese Medicine","city":"Changde","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"the First People's Hospital of Changde","city":"Changde","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taoyuan County People's Hospital","city":"Changde","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Third Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"the First People's Hospital of Chenzhou","city":"Chenzhou","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Central Hospital of Xiangtan","city":"Xiangtan","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inner Mongolia Autonomous Region People's Hospital","city":"Hohhot","state":"Inner Mongolia","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Xuzhou Medical University","city":"Xuzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Dalian Medical University","city":"Dalian","state":"Liaoming","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anshan Changda Hospital","city":"Anshan","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Dalian Medical University","city":"Dalian","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengli Oilfield Central Hospital","city":"Dongying","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinan Third People's Hospital","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liaocheng People's Hospital","city":"Liaocheng","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liaocheng Third People's Hospital","city":"Liaocheng","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The People's Hospital of Gaotang","city":"Liaocheng","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Feixian People's Hospital","city":"Linyi","state":"Shandong","country":"China","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Yeda Hospital","city":"Yantai","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weinan Central Hospital","city":"Weinan","state":"Shannxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chengdu Second People's Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mianyang third people's hospital","city":"Mianyang","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ya 'an People's Hospital","city":"Ya'an","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yueqing People's Hospital","city":"Yueqing","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Chao-Yang Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aerospace Central Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xuanwu Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Fengtai You'anmen Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Red Cross Emergency Medical Center","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Daxing District People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Fuling Hospital","city":"Chongqing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xunming Ji, MD, PhD","phone":"010-8319-9439","email":"jixm@ccmu.edu.cn"},{"name":"Sijie Li, MD","phone":"+8613581610258","email":"lisijie@xwh.ccmu.edu.cn"}],"primaryOutcomes":["The proportion of patients achieving a modified Rankin Scale (mRS) score of 0-2 at 90 days."],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["suzhou-china","taihe-chengguanzhen-china","tongling-china","beijing-china","fuzhou-china","zhangzhou-china","heyuan-china","huizhou-china","shenzhen-china","nanning-china","qinzhou-china","haikou-china","cangzhou-china","shijiazhuang-china","tangshan-china","harbin-china","jiamusi-china","hebi-china","jiaozuo-china","luoyang-china","nanyang-china","shangqiu-china","zhengzhou-china","zhoukou-china","huanggang-china","huangshi-china","jingmen-china","tianmen-china","wuhan-china","xiangyang-china","yichang-china","changde-china","changsha-china","chenzhou-china","xiangtan-china","hohhot-china","xuzhou-china","dalian-china","anshan-china","dongying-china","jinan-china","liaocheng-china","linyi-china","yantai-china","weinan-china","chengdu-china","mianyang-china","yaan-china","wenzhou-china","yueqing-china","chongqing-china"],"enrichment":{"headline":"Phase 3: testing Best medical management for Acute Ischemic Stroke","inPlainEnglish":"For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized. However, less than 50% of patients could achieve functional independence, and over 15% died 90 days after stroke.","whoItsFor":["Ages 18 Years to any","Acute ischemic stroke due to large vessel occlusion in the anterior circulation that is not suitable for intravenous thrombolytic therapy, or has contraindications to intravenous thrombolytic therapy, or treated with intravenous thrombolytic therapy without recanalization;","Baseline score of the National Institutes of Health Stroke Scale (NIHSS) ≥ 6 points;"],"whoShouldSkip":["Imaging examination revealed the presence of multiple vascular supply areas of cerebral infarction (such as the simultaneous presence of infarction in both anterior and posterior circulation);","Absence of femoral artery pulsation, extremely difficult intravascular access, or extremely tortuous large vessels, which are expected to result in the inability to undergo timely endovascular treatment;","Difficult-to-control hypertension: continuous monitoring upon admission shows systolic blood pressure ≥180mmHg, or diastolic blood pressure ≥100mmHg;","Coma or lethargy patients (consciousness level score ≥2 in NIHSS);","Unable to obtain an accurate baseline NIHSS score;","Pre-stroke modified Rankin Scale (mRS) score \\>1;","Baseline ASPECTS score ≤5;"],"whatHappens":"If you join, the listed intervention(s) are 14-day remote ischemic conditioning, 30-day remote ischemic conditioning, or Endovascular thrombectomy. The registry lists allocation as randomized. For patients with acute ischemic stroke caused by large vessel occlusion, endovascular thrombectomy has been demonstrated to be the most effective therapy, as approximately 90% of the occluded vessels can be recanalized.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,105 people at 70 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.222Z"},{"nctId":"NCT06559826","title":"Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression","officialTitle":"A Randomized-Controlled Trial of Ketamine-Assisted Psychotherapy (KAP) Compared to Ketamine Alone for the Treatment of Depression","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"The proposed study is a single-site, randomized, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study participants will be adults with major depressive disorder (MDD). Adults with MDD will be randomized to KAP or KET in a 1:1 allocation. Each treatment group will receive KAP or KET over a period of four weeks. Measurement of depression severity, wellness, neurocognitive functioning and other parameters will occur at baseline prior to treatment, immediately following the end of the acute treatment period, and over an 8-week (two month) treatment follow-up period.","conditions":["Major Depressive Disorder"],"keywords":["Ketamine","Major Depressive Disorder","Ketamine Assisted Psychotherapy"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"BEHAVIORAL","name":"Psychotherapy"}],"enrollment":70,"startDate":"2025-01-10","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study.\n* Age 18-90 years\n* Participant in good physical health\n* Participants may be on medications for depression as long as they remain on a stable dose.\n* A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity.\n* Meets criteria for major depressive disorder (MDD) in current major depressive episode (MDE) according to DSM-5\n* Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion\n\nExclusion Criteria\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease\n* Clinically significant abnormalities of laboratories, physical examination, or ECG\n* Substance drug or alcohol use disorder in the prior 12 months\n* History of hypersensitivity to ketamine or esketamine\n* Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder\n* Presence of psychotic symptoms in the current MDE, or lifetime psychotic disorder\n* Recreational ketamine or phencyclidine use in the last year\n* Previous non-response to clinical or research ketamine or esketamine administration\n* Concurrent treatment with ECT, TMS, or VNS in the current MDE\n* BMI \\> less than or equal to 40.\n* Significant suicidal ideation as determined by a C-SSRS score \\>2 in past 30 days\n* History of suicide attempt or self harm in the prior 2 years\n* SBP \\> 165 or DBP \\> 95 on infusion day\n* MoCA score \\< 23","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rachel Fremont, MD, PhD","phone":"212-241-6539","email":"rachel.fremont@mssm.edu"},{"name":"Mackenzie Brown, MPH","phone":"212-241-6539","email":"mackenzie.brown@mssm.edu"}],"primaryOutcomes":["Montgomery-Asberg Depression Rating Scale (MADRS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Ketamine for Major Depressive Disorder","inPlainEnglish":"The proposed study is a single-site, randomly assigned, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET). Eligible study you would be adults with major depressive disorder (major depression).","whoItsFor":["Ages 18 Years to 90 Years","Participant in good physical health","Participants may be on medications for depression as long as they remain on a stable dose","A score of at least 20 on the 10 item Montgomery-Asberg Depression Scale at screening, corresponding to at least moderate current depression severity","Meets criteria for major depressive disorder (major depression) in current major depressive episode (MDE) according to DSM-5","Women of child-bearing potential must have a negative pregnancy test at screening and prior to ketamine infusion"],"whoShouldSkip":["Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study","Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data","Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and uncontrolled hypertension); endocrinologic, neurologic, immunologic, or hematologic disease","Clinically significant abnormalities of laboratories, physical examination, or ECG","Substance drug or alcohol use disorder in the prior 12 months","History of hypersensitivity to ketamine or esketamine","Lifetime history of schizophrenia, schizoaffective disorder, bipolar I or II disorder"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Psychotherapy. The registry lists allocation as randomized. The proposed study is a single-site, randomly assigned, controlled clinical trial (RCT) comparing ketamine-assisted psychotherapy (KAP) to a standard evidence-based regimen of ketamine administered in a medical model without psychotherapy (KET).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at New York. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.120Z"},{"nctId":"NCT06559852","title":"The Impact of Yoga on Endometriosis-Related Pain","officialTitle":"The Impact of Yoga on Endometriosis-Related Pain","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Milton S. Hershey Medical Center","sponsorClass":"OTHER","summary":"The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.","conditions":["Endometriosis"],"keywords":["Pelvic Pain"],"interventions":[{"type":"BEHAVIORAL","name":"Yoga"}],"enrollment":30,"startDate":"2026-10-15","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Reproductive aged women 18-45\n2. Self-reported prior surgery with pathology confirming a diagnosis of endometriosis\n3. No current use of yoga\n4. Baseline moderate pain, score greater than or equal to 5 on VAS scoring\n5. Access to internet with wifi capability for zoom platform and completion of weekly surveys\n6. Access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water)\n7. Ability to commit to duration of 12-week yoga course\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Established yoga participation or moderate exercise regimen\n3. Physical trauma or disability\n4. Planned surgery or hormonal medication change during study\n5. Non-English speaking patients","locations":[{"facility":"Penn State Health","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Linda Li, MD","phone":"7175313503","email":"lindali@pennstatehealth.psu.edu"},{"name":"Ashlie Carter, MD","phone":"7175313503","email":"acarter8@pennstatehealth.psu.edu"}],"primaryOutcomes":["Change in Endometriosis Health Profile-30 Pain Score"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["hershey-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Yoga for Endometriosis","inPlainEnglish":"The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.","whoItsFor":["Ages 18 Years to 45 Years","Reproductive aged women 18-45","Self-reported prior surgery with pathology confirming a diagnosis of endometriosis","No current use of yoga","Baseline moderate pain, score greater than or equal to 5 on VAS scoring","Access to internet with wifi capability for zoom platform and completion of weekly surveys","Access to items required for yoga session participation (2 blankets or towels, firm pillow, stable chair, wall space, comfortable clothing, water)","Ability to commit to duration of 12-week yoga course"],"whoShouldSkip":["Established yoga participation or moderate exercise regimen","Physical trauma or disability","Planned surgery or hormonal medication change during study","Non-English speaking patients"],"whatHappens":"If you join, the listed intervention(s) are Yoga. The registry lists allocation as na. The central hypothesis of the investigators is that the practice of yoga will result in an improvement of endometriosis related pain symptoms for women with endometriosis.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Hershey. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.112Z"},{"nctId":"NCT06561386","title":"A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1%","officialTitle":"A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination With Chemotherapy Versus Pembrolizumab With Chemotherapy as First-line Treatment for Participants With Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and With Tumor Cell PD-L1 Expression ≥ 1%","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%","conditions":["Non-small Cell Lung Cancer"],"keywords":["Non-squamous","PDL-1 ≥ 1%"],"interventions":[{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Relatlimab"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Cisplatin"}],"enrollment":1000,"startDate":"2024-10-07","completionDate":"2030-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.\n* Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.\n* Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.\n* Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.\n* Participants must have a life expectancy of at least 3 months at the time of randomization.\n\nExclusion Criteria\n\n* Participants must not be pregnant and/or breastfeeding.\n* Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.\n* Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.\n* Participants must not have untreated central nervous system (CNS) metastases.\n* Participants must not have leptomeningeal metastases (carcinomatous meningitis).\n* Participants must not have concurrent malignancy requiring treatment.\n* Participants must not have an active autoimmune disease.\n* Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management.\n* Participants must not have a history of myocarditis.\n* Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Note: Anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapy given in an adjuvant, neoadjuvant or perioperative setting with at least 6 months between the last dose and date of recurrence are allowed.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 0487","city":"Mobile","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Southern Arizona VA Health Care System","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0112","city":"Los Angeles","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of California Davis (UC Davis) Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0159","city":"San Francisco","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"UCLA Hematology/Oncology - 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49%"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab","nivolumab"],"locationSlugs":["mobile-alabama","tucson-arizona","los-angeles-california","sacramento-california","san-francisco-california","santa-monica-california","grand-junction-colorado","westminster-colorado","miami-florida","pembroke-pines-florida","st-petersburg-florida","tamarac-florida","west-palm-beach-florida","coeur-dalene-idaho","chicago-ridge-illinois","wichita-kansas","edgewood-kentucky","lexington-kentucky","paducah-kentucky","annapolis-maryland","royal-oak-michigan","hattiesburg-mississippi","kansas-city-missouri","bozeman-montana","reno-nevada","morristown-new-jersey","paterson-new-jersey","summit-new-jersey","albuquerque-new-mexico","hawthorne-new-york","new-york-new-york","northport-new-york","rochester-new-york","schenectady-new-york","syracuse-new-york","the-bronx-new-york","asheville-north-carolina","greenville-north-carolina","canton-ohio","centerville-ohio","cincinnati-ohio","cleveland-ohio","elyria-ohio","massillon-ohio","zanesville-ohio","lancaster-pennsylvania","philadelphia-pennsylvania","abilene-texas","harlingen-texas","houston-texas","tyler-texas","salt-lake-city-utah","edmonds-washington","issaquah-washington","lacey-washington","seattle-washington","ciudad-aut-noma-de-buenos-aires-argentina","abb-argentina","r-o-cuarto-argentina","bariloche-argentina","rosario-argentina","c-rdoba-argentina","mar-del-plata-argentina","gosford-australia","st-leonards-australia","brisbane-australia","elizabeth-vale-australia","box-hill-australia","murdoch-australia","krems-austria","wels-austria","vienna-austria","edegem-belgium","brussels-belgium","hasselt-belgium","yvoir-belgium","roeselare-belgium","li-ge-belgium","fortaleza-brazil","belo-horizonte-brazil","bel-m-brazil","natal-brazil","porto-alegre-brazil","itaja-brazil","timb-brazil","barretos-brazil","bauru-brazil","s-o-caetano-do-sul-brazil","taubat-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","montreal-canada","santiago-chile","vi-a-del-mar-chile","hefei-china","beijing-china","chongqing-china","wanzhou-china","fuzhou-china","guangzhou-china","huizhou-china","liuzhou-china","nanning-china","harbin-china","xinxiang-china","zhengzhou-china","wuhan-china","changsha-china","huaian-china","nanchang-china","shenyang-china","xian-china","jinan-china","shanghai-china","taiyuan-china","chengdu-china","neijiang-china","tianjin-china","hangzhou-china","linhai-china","medell-n-colombia","bogot-colombia","valledupar-colombia","pereira-colombia","cali-colombia","copenhagen-denmark","aarhus-denmark","s-nderborg-denmark","dijon-france","brest-france","toulouse-france","montpellier-france","rennes-france","vand-uvre-l-s-nancy-france","lille-france","le-mans-france","toulon-france","pierre-b-nite-france","avignon-france","bayonne-france","bordeaux-france","marseille-france","paris-france","esslingen-am-neckar-germany","ulm-germany","kempten-allg-u-germany","m-nchen-germany","marburg-germany","hanover-germany","dortmund-germany","herne-germany","m-nster-germany","chemnitz-germany","gro-hansdorf-germany","l-beck-germany","berlin-germany","bonn-germany","essen-germany","gauting-germany","badsa-india","bengaluru-india","thiruvananthapuram-india","mumbai-india","new-delhi-india","hyderabad-india","secunderabad-india","varanasi-india","howrah-india","dublin-ireland","bari-italy","ravenna-italy","monza-italy","milan-italy","naples-italy","rome-italy","florence-italy","peschiera-del-garda-italy","bergamo-italy","palermo-italy","siena-italy","nakamura-ku-nagoya-japan","kashiwa-japan","kitakyushu-japan","kurume-japan","fukuyama-shi-japan","sapporo-japan","sagamihara-japan","yokohama-japan","nankoku-japan","natori-shi-japan","sendai-japan","kashihara-japan","niigata-japan","kurashiki-japan","hirakata-japan","sakai-japan","hidaka-japan","hamamatsu-japan","nagaizumi-cho-sunto-gun-japan","koto-japan","akashi-japan","fukushima-japan","gifu-japan","osaka-japan","guadalajara-mexico","m-xico-mexico","quer-taro-mexico","san-luis-potos-city-mexico","harderwijk-netherlands","heerlen-netherlands","s-hertogenbosch-netherlands","zwolle-netherlands","leiden-netherlands","the-hague-netherlands","arnhem-netherlands","groningen-netherlands","tauranga-new-zealand","auckland-new-zealand","dunedin-new-zealand","wellington-new-zealand","konin-poland","poznan-poland","bydgoszcz-poland","warsaw-poland","koszalin-poland","prabuty-poland","lodz-poland","lisbon-portugal","coimbra-portugal","porto-portugal","bucharest-romania","flore-ti-romania","craiova-romania","cluj-napoca-romania","ia-i-romania","ploie-ti-romania","dammam-saudi-arabia","jeddah-saudi-arabia","riyadh-saudi-arabia","soweto-south-africa","johannesburg-south-africa","pretoria-south-africa","sandton-south-africa","cape-town-south-africa","cheongju-si-south-korea","namdong-gu-south-korea","hwasun-south-korea","goyang-si-south-korea","seongnam-si-south-korea","yangsan-south-korea","busan-south-korea","seoul-south-korea","daegu-south-ko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3: testing Nivolumab for Non-small Cell Lung Cancer","inPlainEnglish":"This study wants to compare the how well it works of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%","whoItsFor":["Ages 18 Years to any","Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease","Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization","Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria","Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening","Participants must have a life expectancy of at least 3 months at the time of randomization"],"whoShouldSkip":["Participants must not be pregnant and/or breastfeeding","Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded","Participants must not have untreated central nervous system (CNS) metastases","Participants must not have leptomeningeal metastases (carcinomatous meningitis)","Participants must not have concurrent malignancy requiring treatment","Participants must not have an active autoimmune disease","Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids to assist with management"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab, Relatlimab, or Pembrolizumab. The registry lists allocation as randomized. This study wants to compare the how well it works of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 expression ≥ 1%","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 329 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.648Z"},{"nctId":"NCT06561828","title":"Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making","officialTitle":"Developing Transcranial Neuromodulation Protocols for Learning and Decision-Making","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Institute on Drug Abuse (NIDA)","sponsorClass":"NIH","summary":"Background:\n\nPeople with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards. Researchers want to know how a technique called transcranial magnetic stimulation (TMS) may cause changes in brain activity that may help people with SUD.\n\nObjective:\n\nTo test TMS in healthy volunteers.\n\nEligibility:\n\nHealthy people aged 18 to 45 years who are right-handed.\n\nDesign:\n\nParticipants can volunteer for up to 5 different experiments. Each experiment requires 2 to 8 clinic visits. Each visit will last 3 to 7 hours.\n\nSome visits will include TMS. A coil will be placed on the participant s head. A brief electrical current will pass through the coil to create a magnetic field. Participants may feel a tapping or pulling sensation on the skin under the coil. They may feel a twitch in their face, neck, arm, or leg muscles. Participants may be asked to tense certain muscles during TMS.\n\nSome visits will include functional magnetic resonance imaging (fMRI) scans. Participants will lie on a bed that slides into a large tube. They will perform tasks on a computer inside the tube. The fMRI will show which parts of the brain are used during each task.\n\nParticipants will perform tasks on a computer. Some tasks may be done at a desk as well as during TMS and fMRI. Participants may look at images, listen to sounds, smell odors, or taste flavored liquids. Their vital signs may be monitored and their eye movements may be tracked during tasks.","conditions":["Normal Physiology"],"keywords":["TMS","Decision Making","fMRI","Learning","Behavioral Tasks"],"interventions":[{"type":"DEVICE","name":"continuous Theta Burst Stimulation (cTBS)"},{"type":"DEVICE","name":"intermittent Theta Burst Stimulation (iTBS)"},{"type":"DEVICE","name":"sham Theta Burst Stimulation (sham TBS)"}],"enrollment":600,"startDate":"2026-11-15","completionDate":"2044-11-01","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n* Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals.\n* In good general health based on the assessment of the MAI.\n* Right-handed.\n\nEXCLUSION CRITERIA:\n\nIndividuals who meet any of the following criteria will be excluded from participation:\n\n* Any neurological disorder that would increase seizure risk from TMS such as stroke, brain lesions, previous neurosurgery, epilepsy, any history of seizure or fainting episode of unknown cause, frequent severe headache, or head trauma resulting in loss of consciousness, lasting over 30 minutes or with sequela lasting longer than one month. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise safety or data integrity.\n* Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.).\n* Current use (any use in the past two weeks, daily use for more than one week within past 3 months) of any investigational drug or of any medications with psychotropic (e.g., benzodiazepines, etc.), anti or pro-convulsive action. This will be determined at the discretion of the MAI.\n* Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons.\n* History of noise-induced hearing loss or tinnitus.\n* Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI.\n* Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n* Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months.\n* Participation in any neuromodulation (e.g., TMS, tFUS, tDCS, tACS, etc.) session (excluding the current protocol) in the past two weeks.\n* For tasks that involve gustatory or olfactory stimuli, food intake: History of anaphylaxis, e.g., due to severe asthma or food and non-food allergies (e.g., latex, detergents, soap, etc.). This will disqualify participants for tasks that involve chemosensory stimuli or food intake, but not from the protocol itself.\n* Uncorrected impairments in visual acuity severe enough to affect task participation.\n* Non-English speaking. Justification: Data integrity of some of the cognitive tasks used in this study would be compromised as they have only been validated in English. Most importantly, ongoing communication regarding safety procedures is necessary when participants are undergoing TMS and MRI procedures. The inability to effectively communicate TMS and MRI safety procedures in a language other than English could compromise the safety of non-English speaking participants.\n* Pregnancy. Justification: It is unknown whether MRI and TMS pose risks to fetuses.\n* Any other condition that in the judgment of the investigators is incompatible with participation.","locations":[{"facility":"National Institute on Drug Abuse","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NIDA IRP Screening Team","phone":"(800) 535-8254","email":"researchstudies@nida.nih.gov"},{"name":"Thorsten Kahnt, Ph.D.","phone":"(667) 312-5175","email":"thorsten.kahnt@nih.gov"}],"primaryOutcomes":["Task Performance"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Early phase 1: continuous Theta Burst Stimulation (cTBS) for Normal Physiology","inPlainEnglish":"Background: People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior. These changes may heighten the urge to use drugs or lessen the desire to seek nondrug-related rewards.","whoItsFor":["Ages 18 Years to 45 Years","In order to be eligible to participate in this study, an individual must meet the following criteria:","Aged 18-45 years old. Justification: Many neural processes change with age, and these changes could introduce unwanted variability in the measured signals","In good general health based on the assessment of the MAI"],"whoShouldSkip":["Individuals who meet any of the following criteria will be excluded from participation:","Predisposition to seizures (e.g., first-degree family history of potentially hereditary epilepsy, etc.)","Unable to undergo MRI or TMS due to certain metallic or magnetic devices or implants in the body, claustrophobia, or other reasons","History of noise-induced hearing loss or tinnitus","Recent history (within past 12 months) of learning disability, major DSM-5 psychiatric disorder including major affective disorder, ADHD, obsessive-compulsive disorder, schizophrenia, or PTSD. This will be determined at the discretion of the MAI","Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence","Daily nicotine, alcohol, or drug use (excluding caffeine) for at least 4 continuous weeks within the past 12 months"],"whatHappens":"If you join, the listed intervention(s) are continuous Theta Burst Stimulation (cTBS), intermittent Theta Burst Stimulation (iTBS), or sham Theta Burst Stimulation (sham TBS). The registry lists allocation as randomized. Background: People with substance use disorder (SUD) often have changes in brain function that can make it difficult to control drug-seeking behavior.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 600 people at Baltimore. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.265Z"},{"nctId":"NCT06562582","title":"STunning in Acute Myocardial Infarction - BAS","officialTitle":"STunning in Acute Myocardial Infarction - Beta Blockers, Angiotensin Converting Enzyme Inhibitors and Sodium/Glucose Cotransporter 2 Inhibitors Trial A Low Intervention Clinical Tria","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"NONE","sponsor":"Vastra Gotaland Region","sponsorClass":"OTHER_GOV","summary":"The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)","conditions":["Myocardial Infarct"],"keywords":["ST infarction","PCI","Bisoprolol","Ramipril","Dapagliflozin","Global longitudinal strain (GLS, %)"],"interventions":[{"type":"DRUG","name":"Bisoprolol Oral Tablet"},{"type":"DRUG","name":"Ramipril Oral Product"},{"type":"DRUG","name":"Dapagliflozin Oral Product"}],"enrollment":120,"startDate":"2025-01-06","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)\n2. Informed consent\n\nExclusion Criteria:\n\n1. Killip class ≥ 3\n2. Chronic kidney disease with GFR \\< 25 ml/min/1.73 m2\n3. Pre-existing non-reversible cardiac dysfunction or heart failure\n4. Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor\n5. Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician\n6. Life expectancy less than one year\n7. Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception","locations":[{"facility":"Sahlgrenska University Hospital","city":"Gothenburg","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Björn Redfors, Professor","phone":"+46 31342100","email":"bjoern.redfors@wlab.gu.se"},{"name":"Margareta Scharin Täng, PhD","phone":"0736916467","email":"margareta.scharin.tang@vgregion.se"}],"primaryOutcomes":["Measurement of Global longitudinal strain (GLS, %)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dapagliflozin"],"locationSlugs":["gothenburg-sweden"],"enrichment":{"headline":"Phase 4: testing Bisoprolol Oral Tablet for Myocardial Infarct","inPlainEnglish":"The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)","whoItsFor":["Ages 18 Years to any","Patients with STEMI who undergo primary PCI within 6 hours of symptom onset (Excluding prodromal symptoms)"],"whoShouldSkip":["Chronic kidney disease with GFR \\< 25 ml/min/1.73 m2","Pre-existing non-reversible cardiac dysfunction or heart failure","Current treatment with any beta blocker, RAAS inhibitor or SGLT2 inhibitor","Absolute or relative contraindication to any one of the study drugs that confers a risk of patient safety if the patient participates in the trial and adheres to the protocol-specified recommendations, per the assessment of the treating physician","Life expectancy less than one year","Pregnancy or women of childbearing potential who is not sterilized or is not using a medically accepted form of contraception"],"whatHappens":"If you join, the listed intervention(s) are Bisoprolol Oral Tablet, Ramipril Oral Product, or Dapagliflozin Oral Product. The registry lists allocation as randomized. The objective of this trial is to examine the effect of immediate versus late administration of beta blockers, angiotensin converting enzyme inhibitors (ACEI), and sodium/glucose cotransporter 2 (SGLT2) inhibitors on echocardiographic parameters and biomarkers in subjects with ST-elevation myocardial infarction (STEMI)","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 120 people at Gothenburg. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.968Z"},{"nctId":"NCT06564389","title":"FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients","officialTitle":"A PHASE 1, FIRST IN HUMAN, RANDOMIZED, DOUBLE-BLIND, SPONSOROPEN, PLACEBO-CONTROLLED, SINGLE- AND MULTIPLE DOSE ESCALATION, PARALLEL GROUP STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF PF-07832837 IN HEALTHY PARTICIPANTS AND PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms","conditions":["Healthy Participants","Atopic Dermatitis"],"keywords":["healthy","atopic dermatitis","first in human","monoclonal antibody","anti-inflammatory","pharmacokinetics","pharmacodynamics"],"interventions":[{"type":"DRUG","name":"PF-07832837"},{"type":"OTHER","name":"Placebo"}],"enrollment":119,"startDate":"2024-11-05","completionDate":"2027-06-02","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD\n* Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive.\n* Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests\n* BMI of 17.5 to 40 kg/m2; and a total body weight \\>50 kg (110 lbs)\n* Part 2 only: Must meet the following AD criteria:\n\n  1. Have a clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD.\n  2. Either an inadequate response to treatment with standard of care treatments (excluding systemic immunosuppressant treatments) consistent with AD treatment guidelines (for at least 4 consecutive weeks within 6 to 12 months (depending on time since initial diagnosis) of the first dose of the study intervention. OR Have a documented reason why topical treatments are considered medically inappropriate within the last year.\n  3. Have moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits).\n  4. Have an otherwise healthy medical evaluation (other than signs and symptoms of AD) including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests.\n\nControlled comorbid diseases are acceptable so long as they do not require administration of prohibited medications. This includes participants with mild or moderate asthma that is well-controlled (not requiring high dose inhaled corticosteroids, systemic \\[oral or parenteral\\] corticosteroids, or biologic asthma treatments).\n\nExclusion Criteria:\n\n* Have a history of systemic infection requiring hospitalization and parenteral antimicrobial therapy, any lymphoproliferative disorder, malignancies.\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological disorder.\n* Have undergone significant trauma or major surgery within 1 month of the first dose of study intervention.\n* Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following:\n\n  1. A positive QuantiFERON-TB Gold In-tube or equivalent test.\n  2. History of either untreated or inadequately treated latent or active TB infection, or current treatment for the same.\n\nPart 2 Only\n\n* Currently have active forms of other inflammatory skin diseases\n* Have history of or current evidence of skin conditions at the time of Day 1 that would interfere with evaluation of atopic dermatitis or response to treatment. Have active chronic or acute skin infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks prior to Day 1, or superficial skin infections within 1 week prior to Day 1.\n* Score of ≥ 5 on the Fitzpatrick Skin Type Assessment.\n* History of anaphylaxis with the following exceptions: participants with sensitivity and/or anaphylaxis only to a single, avoidable allergen (eg, aspirin, penicillin, sulfa drugs, nonsteroidal anti-inflammatory drugs \\[NSAIDs\\], peanuts) may be enrolled, if in the opinion of the investigator, the participant is aware of the hypersensitivity and avoids the problematic allergen. Participants must carry appropriate treatment for anaphylaxis and must know how to manage anaphylactic reactions.\n* Any investigational or experimental therapy taken or procedure performed for AD, psoriasis, psoriatic arthritis, rheumatoid arthritis or other inflammatory diseases in the previous 1 year should be discussed with the Pfizer Medical Monitor (or designee).","locations":[{"facility":"Anaheim Clinical Trials, LLC","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TCR Medical Corporation","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Dermatology and Laser Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paddington Testing Company","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Angelius Provita","city":"Katowice","state":"Silesian Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki","city":"Szczecin","state":"West Pomeranian Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) and serious adverse events (SAEs) Following single ascending doses (SAD)","Number of Participants with Clinically significant Laboratory Abnormalities Following SAD","Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following SAD","Number of Participants with Clinically Significant Change from Baseline in Vital Signs Following SAD","Number of Participants with Clinically Significant Change from Baseline in Cardiac Telemetry Findings Following SAD","Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs Following multiple ascending doses (MAD)","Number of Participants with Clinically significant Laboratory Abnormalities Following MAD","Number of Participants with Change from Baseline in Electrocardiogram (ECG) Findings Following MAD","Number of Participants With Treatment Emergent Treatment-Related AEs and SAEs in participants with atopic dermatitis (AD)","Number of Participants with Clinically significant Laboratory Abnormalities in participants with AD","Number of Participants with Clinically Significant Change from Baseline in Vital Signs in participants with AD"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["anaheim-california","san-diego-california","miami-florida","troy-michigan","philadelphia-pennsylvania","katowice-poland","szczecin-poland","lodz-poland"],"enrichment":{"headline":"Phase 1: testing PF-07832837 for Healthy Participants","inPlainEnglish":"The purpose of the study is to measure the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis. An additional goal is to assess the pharmacodynamics of PF-07832837 in participants with moderate to severe AD, including potential effects on clinical signs and symptoms","whoItsFor":["Ages 18 Years to 70 Years","Part 1 only: Adult participants between 18 to 55 years of age, inclusive, at the time of signing the ICD","Part 2 only: Adult participants, who at the time of screening, are between the ages of 18 and 70 years, inclusive","Part 1 only: Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, vital sign assessments, temperature, 12-lead ECGs, laboratory tests","body-mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight \\>50 kg (110 lbs)","Part 2 only: Must meet the following AD criteria:","Have a clinical diagnosis of chronic AD (also known as atopic eczema) for at least 1 year prior to Day 1 and have the diagnosis of AD confirmed by photographs (at screening) and diagnostic criteria for AD","Have moderate to severe AD (defined as having an affected BSA (captured as part of EASI) ≥10%, IGA ≥3, and EASI ≥12 at both the screening and baseline visits)"],"whoShouldSkip":["Have a history of systemic infection requiring hospitalization and parenteral antimicrobial therapy, any lymphoproliferative disorder, malignancies","Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, immunological/rheumatological disorder","Have undergone significant trauma or major surgery within 1 month of the first dose of study intervention","Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by both of the following:","A positive QuantiFERON-TB Gold In-tube or equivalent test","History of either untreated or inadequately treated latent or active TB infection, or current treatment for the same","Currently have active forms of other inflammatory skin diseases"],"whatHappens":"If you join, the listed intervention(s) are PF-07832837, or Placebo. The registry lists allocation as randomized. The purpose of the study is to measure the safety, tolerability, and pharmacokinetics of escalating single and repeat doses of PF-07832837 in healthy participants and in participants with moderate to severe atopic dermatitis.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 119 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.822Z"},{"nctId":"NCT06566170","title":"A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease","officialTitle":"Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Donanemab"},{"type":"DRUG","name":"Usual Care"}],"enrollment":6250,"startDate":"2024-10-07","completionDate":"2031-05","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants\n\n* are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \\[EHR\\] is required prior to screening)\n* have a Telephone Interview for Cognitive Status (TICS) score of ≥21\n* presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \\[CSF\\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)\n* have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and\n* have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.\n\nExclusion Criteria:\n\n* have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)\n* have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (\\>12 months) institutional-level care, serious psychiatric illness, etc.)\n* are currently enrolled or intend to enroll in a clinical trial of another investigational product, and\n* have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).","locations":[{"facility":"Rehabilitation & Neurological Services","city":"Huntsville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["huntsville-alabama"],"enrichment":{"headline":"Not a traditional drug phase: testing Donanemab for Alzheimer Disease","inPlainEnglish":"The main purpose of this study is to measure the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, watch-and-measure (no experimental treatment required) cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records.","whoItsFor":["Ages 60 Years to any","are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records \\[EHR\\] is required prior to screening)","have a Telephone Interview for Cognitive Status (TICS) score of ≥21","presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid \\[CSF\\]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)","have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and","have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study"],"whoShouldSkip":["have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)","are currently enrolled or intend to enroll in a clinical trial of another investigational product, and","have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 6,250 people at Huntsville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.496Z"},{"nctId":"NCT06570473","title":"Feasibility Trial for a Right Ventricular Failure Platform Trial","officialTitle":"Feasibility Trial for the Canadian Right Ventricular AdaptiVE (CRAVE) Platform for Therapies Targeting Right Ventricular Failure","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomized trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.","conditions":["Pulmonary Hypertension","Right Ventricular Dysfunction","Right Heart Failure"],"keywords":["Pulmonary Hypertension","Right Ventricular Dysfunction","Right Heart Failure","Empagliflozin","Ranolazine"],"interventions":[{"type":"DRUG","name":"Empagliflozin"},{"type":"DRUG","name":"Ranolazine"}],"enrollment":30,"startDate":"2025-07-15","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Able to provide informed consent.\n3. Able to comply with all study procedures.\n4. History of RV dysfunction or RHF secondary to any of:\n\n   a. Group 1 PH, pulmonary arterial hypertension b. Group 2 PH, left heart disease with normal left ventricular ejection fraction (LVEF) \\> 50% and a previous RHC demonstrating combined pre and post-capillary PH, defined as: i. mPAP \\>20 mmHg ii. PAWP \\> 15 mmHg iii. PVR\\> 2 WU c. Group 3 PH d. Group 4 PH, chronic thromboembolic PH that is either persistent after pulmonary endarterectomy or inoperable due to distal disease.\n5. Symptomatic with current NYHA Functional Class II-IV\n6. Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:\n\n   1. NT-proBNP \\>300 ng/L and qualitative evidence of at least 'mild' RV dysfunction on echocardiography OR NT-proBNP\\<300 ng/L and qualitative evidence of at least moderate RV dysfunction and/or dilatation on 2D echocardiogram AND\n   2. A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following:\n\n   i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \\> 42 mm at the base).\n7. Receiving loop diuretics or mineralocorticoid receptor antagonists for at least 4 weeks.\n8. Access to an iOS or android smart phone or tablet.\n\nExclusion Criteria:\n\n1. Estimated glomerular filtration rate (eGFR) \\<30 ml/min.\n2. LVEF \\< 50%\n3. Normal RV size and function\n4. Severe aortic or mitral valvular disease\n5. Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)\n6. Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability\n7. Pregnancy or lactation\n8. Unable to provide consent and comply with follow-up visits\n9. Listed for lung, heart or heart/lung transplantation\n10. Myocardial infarction or acute coronary syndrome within 90 days of screening\n11. Enrolled in another interventional trial\n12. Planned cardiac or thoracic surgical intervention in the next 6 months.\n13. Known hypersensitivity to empagliflozin or ranolazine.\n14. Concurrent treatment with:\n\n    * strong inhibitors of Cytochrome P450 3A4 (CYP 3A4), (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, nelfinavir, ritonavir, indinavir, saquinavir and grapefruit juice)\n    * class IA antiarrhythmics (e.g., quinidine, procainamide, disopyramide) or class III antiarrhythmics (e.g., sotalol, ibutilide, amiodarone, dronedarone)\n    * inducers of CYP 3A4 (e.g., rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John's wort)\n15. Congenital long QT syndrome or a QTc interval \\>500 ms","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - University Hospital","city":"London","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital","city":"Ottawa","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jason Weatherald, MD,MSc,FRCPC","phone":"780-492-9937","email":"weathera@ualberta.ca"},{"name":"Courtney Gubbels, BA","phone":"780-492-1113","email":"courtney.gubbels@ualberta.ca"}],"primaryOutcomes":["The proportion of eligible participants approached that consent","The proportion of participants who consent that are randomized","Average enrolment rate of participants per centre per month","Loss of follow up or death","Ability to capture data for secondary outcomes"],"hasResults":false,"conditionSlugs":["heart-failure","hypertension"],"drugSlugs":["empagliflozin"],"locationSlugs":["calgary-canada","edmonton-canada","vancouver-canada","london-canada","ottawa-canada"],"enrichment":{"headline":"Phase 2: testing Empagliflozin for Pulmonary Hypertension","inPlainEnglish":"The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomly assigned trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.","whoItsFor":["Ages 18 Years to any","Able to comply with all study procedures","History of RV dysfunction or RHF secondary to any of:","Symptomatic with current NYHA Functional Class II-IV","Biomarker and 2D echocardiogram evidence of RV dysfunction within 3 months:","NT-proBNP \\>300 ng/L and qualitative evidence of at least 'mild' RV dysfunction on echocardiography OR NT-proBNP\\<300 ng/L and qualitative evidence of at least moderate RV dysfunction and/or dilatation on 2D echocardiogram AND","A quantitative 2D echocardiogram with evidence of RV dysfunction defined as having both of the following:","i. TAPSE ≤18 mm ii. RV dilatation (RV diameter \\> 42 mm at the base)"],"whoShouldSkip":["Estimated glomerular filtration rate (eGFR) \\<30 ml/min","Normal RV size and function","Severe aortic or mitral valvular disease","Moderate or severe hepatic dysfunction (Child-Pugh Class B or C)","Participants requiring augmentation of diuretics or otherwise not meeting definition for clinical stability","Pregnancy or lactation","Listed for lung, heart or heart/lung transplantation"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin, or Ranolazine. The registry lists allocation as randomized. The primary objective of the CRAVE feasibility trial is to assess the feasibility of conducting a larger CRAVE platform trial by performing a randomly assigned trial of 30 participants with pulmonary hypertension and right ventricular dysfunction, comparing empagliflozin or ranolazine plus standard of care to standard of care alone.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.616Z"},{"nctId":"NCT06576310","title":"Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance","officialTitle":"Evaluation of Predictive Factors for Dental Occlusal Changes in the Treatment of Obstructive Sleep Apnea With Mandibular Advancement Appliance","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Toulouse","sponsorClass":"OTHER","summary":"This research addresses obstructive sleep apnea syndrome (OSAS), affecting 6-12% of French adults, often treated with mandibular advancement devices (MADs). MADs may lead to occlusal modifications, causing a 50% treatment abandonment rate. The study employs surface electromyography to assess masticatory muscle activity before and during MAD use, correlating it with occlusal changes after 6 months. The primary goal is to determine dental displacement profiles post-6-month MAD treatment, providing insights for personalized care and minimizing treatment failures.","conditions":["Obstructive Sleep Apnea Syndrome"],"keywords":["MAD therapy","side effect","Dental occlusion","electromyography"],"interventions":[{"type":"DEVICE","name":"Mandibular Advancement Device"}],"enrollment":118,"startDate":"2025-01-06","completionDate":"2027-10-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient with complete dentition (up to second molars)\n* Polysomnography or polygraphy\n* Diagnosis of OSA\n* Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital\n* Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment\n* Individual affiliated with or covered by a social security scheme\n* Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations).\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Pregnant or breastfeeding patient\n* Patient with curators, guardians, or legal protection","locations":[{"facility":"University Hospital of Toulouse","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Constance CUNY, MD","phone":"+33615282467","email":"cuny.c@chut-toulouse.fr"}],"primaryOutcomes":["OCCLUSAL MODIFICATIONS AFTER 6 MONTHS OF OAM TREATMENT","PRIMARY EXPOSURE VARIABLE: MASTICATORY MUSCLE ACTIVITY"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["toulouse-france"],"enrichment":{"headline":"Not a traditional drug phase: Mandibular Advancement Device for Obstructive Sleep Apnea Syndrome","inPlainEnglish":"This research addresses obstructive sleep apnea syndrome (OSAS), affecting 6-12% of French adults, often treated with mandibular advancement devices (MADs). MADs may lead to occlusal modifications, causing a 50% treatment abandonment rate.","whoItsFor":["Ages 18 Years to any","Patient with complete dentition (up to second molars)","Polysomnography or polygraphy","Patient receiving OAM treatment at the Odontology Department of Toulouse University Hospital","Patient with contemporary panoramic and lateral cephalometric X-rays (common practice) taken at the time of orthotic treatment","Individual affiliated with or covered by a social security scheme","Voluntary, informed, written consent, signed by both participant and investigator (prior to inclusion and any necessary research-related examinations)"],"whoShouldSkip":["Pregnant or breastfeeding patient","Patient with curators, guardians, or legal protection"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 118 people at Toulouse. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.941Z"},{"nctId":"NCT06577467","title":"Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection","officialTitle":"Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called \"long COVID.\" Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies.\n\nObjective:\n\nTo collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies.\n\nEligibility:\n\nPeople 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms.\n\nDesign:\n\nParticipants will have 2 to 6 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days.\n\nParticipants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested.\n\nTissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures.\n\nSwabs will be used to collect cells from inside the mouth and nose.\n\nParticipants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord.\n\nParticipants will have follow-up phone calls after each clinic visit.","conditions":["PASC Post Acute Sequelae of COVID-19"],"keywords":["PASC","COVID-19"],"interventions":[],"enrollment":12,"startDate":"2025-03-27","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":"110 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nRecovered Volunteers (RV): Six healthy persons who have recovered from an acute SARS-CoV-2 infection.\n\nInclusion criteria:\n\n* Participants 18 and older\n* Ability to provide informed consent\n* Completed participation in Phase B of Protocol 000089\n* Met 000089 Inclusion criteria for Mild to Moderate COVID-19 without PASC symptoms:\n\n  * Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.\n  * A self-reported illness narrative of recovery to prior health after a SARS/CoV2 infection.\n  * Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test.\n  * Meets WHO Clinical Progression Scale of 2 - 6:\n\n    2: Ambulatory; symptomatic, independent\n\n    3: Ambulatory; symptomatic, assistance needed\n\n    4: Hospitalized; no oxygen therapy\n\n    5: Hospitalized; oxygen by mask or nasal prongs\n\n    6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen\n  * Functional Criteria: No substantial symptom severity as determined using SF-36v2: score of \\>=85 physical function subscale, and \\>=85 on role physical subscale, and \\>=85 on social function subscale.\n* Determined to be a Healthy Comparator by the 000089 Case Adjudication Committee\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.\n\nNeurologic Post-Acute Sequelae of COVID-19 Participants (Neuro-PASC):\n\nSix persons with ongoing neurological complaints following an acute SARS-CoV-2 infection.\n\nInclusion criteria:\n\n* Participants 18 and older\n* Ability to provide informed consent\n* Completed participation in Phase B of Protocol 000089\n* Met 000089 Inclusion criteria for Mild to Moderate COVID-19 with PASC symptoms:\n\n  * Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel.\n  * A self-reported illness narrative of the development of persistent PASC symptoms after recovering from a SARS-CoV-2 infection. These include symptoms such as fatigue, cognitive difficulties, orthostatic intolerance, unrefreshing sleep, neuropathic pain, mood change, and post-exertional malaise.\n  * Laboratory documentation of a positive COVID-19 PCR, NAA, or other EUA Approved test to confirm active COVID infection at the time of the SARS-CoV-2 infection. Participants with positive home tests during Phase A will be required to have a positive anti-SARS nucleocapsid antibody test .\n  * Meets WHO Clinical Progression Scale of 2 - 6:\n\n    2: Ambulatory; symptomatic, independent\n\n    3: Ambulatory; symptomatic, assistance needed\n\n    4: Hospitalized; no oxygen therapy\n\n    5: Hospitalized; oxygen by mask or nasal prongs\n\n    6: Hospitalized; oxygen by non-invasive ventilation or high flow oxygen\n  * Functional Criteria: Substantial symptom severity as determined using SF-36v2: score of \\<= 70 physical function subscale, or \\<=50 on role physical subscale, or \\<=75 on social function subscale.\n* Determined to have Post-Acute Sequelae of COVID-19 by the 000089 Case Adjudication Committee\n* Primary PASC complaint is neurologic including:\n\n  * Neuropathic sensations\n  * Cognitive complaints\n  * Postural (Orthostatic) complaints\n  * Motor complaints\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing. Testing may be repeated with each admission. Participants may be rescreened 6 weeks after acute infection has resolved.\n\nEXCLUSION CRITERIA:\n\n* Current suicidal ideation\n* Women who are pregnant, breastfeeding, or are within one-year post-partum.\n* Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed.\n* Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed.\n* Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment.\n* Long term use of anticoagulant or antiplatelet medications.\n* Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study.\n* Not willing to allow for research data and samples to be shared broadly with other researchers.\n* Employees of NIH.\n* Symptom severity that makes it impossible for the volunteer to travel to NIH for an extended inpatient evaluation\n* Use of medications with a high-risk for withdrawal-related complications (i.e. long-acting opiates or benzodiazepines).\n* Unwillingness to co-enroll in protocol 17-I-0122: NIAID Centralized Sequencing Protocol.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cynthia L Vierria","phone":"(301) 594-6760","email":"cynthia.vierria@nih.gov"},{"name":"Avindra Nath, M.D.","phone":"(301) 496-1561","email":"natha@mail.nih.gov"}],"primaryOutcomes":["To determine where remnants of SARS-CoV-2 virus can be recovered in persons with neuro-PASC and RVs."],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection","inPlainEnglish":"Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends.","whoItsFor":["Ages 18 Years to 110 Years","Recovered Volunteers (RV): Six healthy persons who have recovered from an acute SARS-CoV-2 infection","who can join:","Participants 18 and older","Completed participation in Phase B of Protocol 000089","Met 000089 who can join for Mild to Moderate COVID-19 without PASC symptoms:","Licensed Independent Practitioner documentation of a stable state of general well-health and physical function prior to contracting SARS-CoV-2. This may include medical records, correspondence letters, or information gathered from telephone calls with study personnel","A self-reported illness narrative of recovery to prior health after a SARS/CoV2 infection"],"whoShouldSkip":["Current suicidal ideation","Women who are pregnant, breastfeeding, or are within one-year post-partum","Current or previous malignancy. A history of malignancy that has fully resolved with surgical resection only (e.g. no chemotherapy, radiation therapy, or immunotherapy) will be allowed","Current systemic immunologic disorders (e.g. Type 1 diabetes, rheumatoid arthritis). Local immunological disorder (e.g. atopic dermatitis, stable autoimmune thyroid disease) and allergic disorders will be allowed","Current or previous long-term immune suppressive therapy. Systemic steroid use, even short-term, must not have been used within the month prior to enrollment","Long term use of anticoagulant or antiplatelet medications","Active participation in a clinical protocol (e.g. anti-inflammatory drug intervention study) which includes an intervention that may affect the results of the current study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 12 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.240Z"},{"nctId":"NCT06577844","title":"Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients","officialTitle":"Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Assistance Publique Hopitaux De Marseille","sponsorClass":"OTHER","summary":"Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).","conditions":["Lung Cancer"],"keywords":["lung cancer","surgery","anxiety","video support"],"interventions":[{"type":"OTHER","name":"video support"}],"enrollment":226,"startDate":"2024-07-11","completionDate":"2028-01-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 18 or over,\n* Patients requiring surgical management:\n\nfor therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),\n\n\\- Patients who have given their consent.\n\nExclusion Criteria:\n\n* Patients under guardianship\n* Patients with a history of thoracic surgery\n* Patients on long-term analgesic medication\n* Patients who do not speak French\n* Patients unable to read or write\n* Patients with major visual impairment\n* Patients with chronic anxiety or depression at the time of admission\n* Patients under guardianship\n* Pregnant or breast-feeding women","locations":[{"facility":"Assistance publique Hopitaux de Marseille - Hopital Nord","city":"Marseille","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alex FOURDRAIN, DR","phone":"+33 4 91 96 43 95","email":"alex.fourdrain@ap-hm.fr"}],"primaryOutcomes":["Immediate pre-operative anxiety"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["marseille-france"],"enrichment":{"headline":"Not a traditional drug phase: video support for Lung Cancer","inPlainEnglish":"Uni-centric, randomly assigned, open-label, prospective treatment-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).","whoItsFor":["Ages 18 Years to any","Patients aged 18 or over,","Patients requiring surgical management:","for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),","\\- Patients who have given their consent"],"whoShouldSkip":["Patients under guardianship","Patients with a history of thoracic surgery","Patients on long-term analgesic medication","Patients who do not speak French","Patients unable to read or write","Patients with major visual impairment","Patients with chronic anxiety or depression at the time of admission"],"whatHappens":"If you join, the listed intervention(s) are video support. The registry lists allocation as randomized. Uni-centric, randomly assigned, open-label, prospective treatment-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 226 people at Marseille. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.723Z"},{"nctId":"NCT06578104","title":"PULSED AF Post-Approval Study","officialTitle":"PULSED AF Post-Approval Study, an Addendum to the PulseSelect™ PFA Global Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Medtronic Cardiac Ablation Solutions","sponsorClass":"INDUSTRY","summary":"PULSED AF PAS is a prospective, global, multi-center, non-randomized, observational trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"PulseSelect™ PFA system"}],"enrollment":580,"startDate":"2024-11-04","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF\n* Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)\n* Patient is ≥ 18 years of age\n* Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System\n* Willing and able to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this clinical study) or authorization per institution and geographical requirements\n\nExclusion Criteria\n\n* Long-standing persistent AF (continuous AF sustained \\>12 months)\n* Prior left atrial catheter or surgical ablation\n* Patient with life expectancy \\< 36 months\n* Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)\n* Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager","locations":[{"facility":"University of South Florida Health (USF)","city":"Tampa","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Piedmont Heart Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health Swedish Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pikeville Medical Center","city":"Whitesburg","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southcoast Health System","city":"Fall River","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beaumont Health System","city":"Royal Oak","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Valley Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health Lenox Hill Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center (DUMC)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bethesda North Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Mount Carmel Grove City Medical Center","city":"Grove City","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Doylestown Health Cardiology a division of Doylestown Health Physicians","city":"Doylestown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AnMed Health Center","city":"Anderson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina (MUSC)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Health Research & Education Institute","city":"Dallas","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Medical Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Confluence Health Hospital Central Campus","city":"Wenatchee","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - University Campus","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Heart Institute","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Josman Suri","phone":"7635050262","email":"josman.suri@medtronic.com"}],"primaryOutcomes":["Efficacy-Freedom from Atrial Fibrillation","Safety- Freedom from Device/Procedure Related Adverse Events"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["tampa-florida","atlanta-georgia","chicago-illinois","whitesburg-kentucky","fall-river-massachusetts","royal-oak-michigan","omaha-nebraska","new-york-new-york","durham-north-carolina","cincinnati-ohio","columbus-ohio","grove-city-ohio","doylestown-pennsylvania","anderson-south-carolina","charleston-south-carolina","dallas-texas","charlottesville-virginia","wenatchee-washington","london-canada","toronto-canada","montreal-canada","daegu-south-korea"],"enrichment":{"headline":"Not a traditional drug phase: PulseSelect™ PFA system for Atrial Fibrillation","inPlainEnglish":"PULSED AF PAS is a prospective, global, multi-center, non-randomly assigned, watch-and-measure (no experimental treatment required) trial. Subjects will be treated with the PulseSelect™ PFA System and followed through 36 months.","whoItsFor":["Ages 18 Years to any","A diagnosis of recurrent symptomatic paroxysmal AF or persistent AF","Refractory to at least one Class I or III antiarrhythmic drug (i.e., not effective, not tolerated, or not desired)","Patient is ≥ 18 years of age","Planned pulmonary vein isolation procedure with the commercially available PulseSelect™ PFA System"],"whoShouldSkip":["Long-standing persistent AF (continuous AF sustained \\>12 months)","Prior left atrial catheter or surgical ablation","Patient with life expectancy \\< 36 months","Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)","Current or anticipated participation in any other clinical trial of a drug, device, or biologic not approved by the global study manager"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 580 people at 23 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.747Z"},{"nctId":"NCT06578195","title":"ASSESS ALL ALS Study","officialTitle":"ASSESS ALL ALS - Longitudinal Biomarker Study for Symptomatic ALS and Control Participants","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"St. Joseph's Hospital and Medical Center, Phoenix","sponsorClass":"OTHER","summary":"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital. The clinical sites are distributed across the country, and led by a group of collaborative principal investigators. Once data and samples are collected and harmonized, it will be made available to research community for future research into ALS and related neurological diseases.\n\nASSESS protocol is specific for symptomatic ALS and control participants. This protocol includes both on-site and off-site(remote) participants. The participants will be followed for 24 months (2 years), and will include collection of medical history, clinical outcomes, and blood samples once in 4 months. Additionally, the participants will complete patient reported outcomes and speech recordings once a month. Participants who are coming into clinic may also provide optional Cerebrospinal Fluid (CSF) samples.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["ALS","Amyotrophic Lateral Sclerosis","biomarker","observational"],"interventions":[],"enrollment":2000,"startDate":"2024-07-25","completionDate":"2029-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria for ALS participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. Diagnosis of ALS by a physician\n5. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nInclusion Criteria for control participants:\n\n1. Age 18 years or older\n2. Capable of providing informed consent\n3. Willing to follow study procedures\n4. No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)\n5. No history of familial ALS/Frontotemporal Dementia (FTD) in a close family member\\*\\* unless the participant has previously tested negative for the known causative ALS genes. Participants with a family history of singleton ALS are permitted to enroll.\n\n   * \\*\\* Defined by the presence of a known ALS causative gene such as C9orf72 in a family member or a family history suggestive of an inherited ALS/FTD syndrome defined by two family members with a history of ALS and/or FTD.\n6. Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)\n\nExclusion Criteria for all participants:\n\n1. Significant cognitive impairment, clinical dementia, or unstable psychiatric illness, including psychosis, active suicidal ideation, suicide attempt, or untreated major depression \\<= 90 days of screening, that would interfere with the study procedure, according to Investigator's judgement.\n2. Clinically significant unstable medical condition (other than ALS) (e.g., cardiovascular instability, systemic infection, untreated thyroid dysfunction, malignant and potentially progressive cancer) that would render the participant unlikely to be able to complete 12 months of follow-up, according to Investigator's judgment.\n\nExclusion Criteria for participants undergoing optional Lumbar Puncture\n\n1. Medically unable to undergo lumbar puncture (LP) as determined by the site investigator (i.e., bleeding disorder, a skin infection at or near the LP site, known or suspected intracranial or intraspinal tumor or other cause of increased intracranial pressure).\n2. Allergy to Lidocaine or other local anesthetic agents.\n3. Use of anticoagulant medication or antiplatelet medications (aside from aspirin 81 mg) that cannot be safely withheld prior to lumbar puncture.\n4. Blood dyscrasia, abnormal bleeding diathesis, or the use of dialysis for renal failure.\n5. Current pregnancy based on participant self-report\n6. Clinical judgement of the site investigator that the participant would be unable to undergo multiple lumbar punctures.","locations":[{"facility":"University of Alabama Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barrow Neurological Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital For Special Care","city":"New Britain","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georgetown University","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nova Southeastern University","city":"Davie","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Regional Medical Center","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synapticure (Remote Participation Only)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nih/Ninds","city":"Bethseda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Brigham","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Colombus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence ALS Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Health","city":"Hershey","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Neurology","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHALS-CCT, University of Puerto Rico, Medical Sciences Campus","city":"San Juan","state":"Puerto Rico","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ALL ALS Patient Navigator","phone":"602-845-0248","email":"info@all-als.org"}],"primaryOutcomes":["ALS Functional Rating Scale-Revised (ALSFRS-R)","ALS Functional Rating Scale-Revised Self entry (ALSFRS-RSE)"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","irvine-california","la-jolla-california","los-angeles-california","san-francisco-california","aurora-colorado","new-britain-connecticut","washington-d-c-district-of-columbia","davie-florida","jacksonville-florida","boise-idaho","chicago-illinois","indianapolis-indiana","baltimore-maryland","bethseda-maryland","boston-massachusetts","ann-arbor-michigan","detroit-michigan","minneapolis-minnesota","st-louis-missouri","omaha-nebraska","lebanon-new-hampshire","new-york-new-york","durham-north-carolina","colombus-ohio","portland-oregon","hershey-pennsylvania","philadelphia-pennsylvania","nashville-tennessee","dallas-texas","salt-lake-city-utah","richmond-virginia","seattle-washington","san-juan-puerto-rico"],"enrichment":{"headline":"ASSESS ALL ALS Study","inPlainEnglish":"The ALL ALS Clinical Research Consortium is establishing research to collect a wide range of samples, clinical information and measurements from Amyotrophic Lateral Sclerosis (ALS) symptomatic, ALS gene carriers and control cohorts. This consortium is being funded by the National Institutes of Health/National Institute of Neurological Disorders and Stroke (NIH/NINDS) and managed by two clinical coordinating centers (CCC) at Barrow Neurological Institute and Massachusetts General Hospital.","whoItsFor":["Ages 18 Years to any","for ALS participants:","Age 18 years or older","Willing to follow study procedures","Diagnosis of ALS by a physician","Access to a smartphone, computer or tablet, and internet (need not be in the home - access to a public library or other available computer with internet connection is sufficient)","who can join for control participants:","No diagnosis of ALS , Progressive Muscular Atrophy (PMA) or Primary Lateral Sclerosis (PLS)"],"whoShouldSkip":["for all participants:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at 37 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.601Z"},{"nctId":"NCT06578624","title":"Safety and Preliminary Efficacy of SA53-OS in Patients With Locally Advanced or Metastatic Solid Tumors","officialTitle":"A Phase 1/2a, Open-Label Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SA53-OS, an MDM2 Inhibitor, in Patients With Locally Advanced or Metastatic p53 Wild-Type Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Lamassu Bio Inc","sponsorClass":"INDUSTRY","summary":"The objective of this study is to assess the safety, efficacy, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.\n\nThe study is comprised of 2 parts: Part 1 called dose escalation, and Part 2a called dose expansion. This study starts with Part 1 where participants who are diagnosed with advanced or metastatic solid tumor cancers receive different doses of SA53-OS (starting with the lowest dose) to find the maximum tolerated dose (MTD) of SA53-OS. Once the MTD of SA53-OS is known, the study continues to Part 2a where participants who are diagnosed with dedifferentiated liposarcoma (DD LPS) or other solid tumor cancers will receive SA53-OS at the MTD.\n\nThe study drug, SA53-OS, will be administered for 3 consecutive days every 3 weeks as an oral solution for up to 2 years.","conditions":["Solid Tumor"],"keywords":["p53 wild-type tumor","liposarcoma","MDM2 inhibitor","solid tumors","dedifferentiated liposarcoma (DD LPS)","p53","Advanced or metastatic solid tumors"],"interventions":[{"type":"DRUG","name":"SA53-OS (phase 1)"},{"type":"DRUG","name":"SA53-OS (phase 2)"}],"enrollment":55,"startDate":"2025-06-16","completionDate":"2031-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Tumor characteristics of participants in Phase 1\n\n  1. Histologically and/or cytologically confirmed diagnosis of advanced or metastatic solid tumor and/or non-Hodgkin lymphoma excluding primary central nervous system malignancy for which no standard effective treatment exists or where that treatment was declined. Participants with non-Hodgkin lymphoma should have failed ≥ 2 prior lines of systemic therapy prior enrollment.\n  2. Tumor p53 wild-type.\n* Tumor characteristics of participants in Phase 2a\n\n  1. Cohort A: Tumor p53 wild-type with histologically confirmed diagnosis of advanced or metastatic DD LPS (and MDM2 amplification); OR Cohort B: Tumor p53 wild-type in other solid tumor.\n  2. Measurable disease by RECIST 1.1.\n* 18 years old or older.\n* Resolution of clinically relevant toxicity-related to prior anticancer therapies prior to receipt of study treatment to Grade 1 or less.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants of childbearing/reproductive potential must agree to use adequate birth control measures during the course of the trial and for at least 3 months after discontinuing study treatment.\n\nExclusion Criteria:\n\n* Anticipated need for major surgery and/or localized palliative radiation within the next 6 weeks\n* Active, untreated central nervous system metastases. Participants with brain metastases identified at Screening may be rescreened after the lesion(s) have been appropriately treated; participants with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before start of study treatment, and treated lesions should demonstrate no new growth on the re-screening scan.\n* Known HIV infection or active hepatitis B or C infection.\n* Thrombotic event requiring active and ongoing anticoagulation within the last 6 months prior to study treatment.\n* Myocardial infarction within the last 6 months prior to study treatment.\n* Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure New York Heart Association (NYHA) Class III or IV related to primary cardiac disease, uncontrolled ischemic or severe vascular heart disease.\n* A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n* Known bleeding disorder (e.g., hemophilia, von Willebrand disease).\n* Conditions that may predispose to major bleeding (e.g., active GI ulcers, upper or lower GI bleedings in the last 6 months, significant hemoptysis in the last 6 months, tumor invasion of major vessels, etc.). Conditions that have been treated may be allowed if resolution of the risk is documented.\n* Use or indication for full dose anticoagulation or anti-platelet therapy including low dose aspirin.\n* Women who are pregnant or lactating.","locations":[{"facility":"Gabrail Cancer Center","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Taussig Cancer Institute","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jill Palmenberg","phone":"520-241-5944","email":"jill.palmenberg@lamassubio.com"}],"primaryOutcomes":["Phase 1: Incidence of DLT","Phase 1 and 2: Adverse events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["canton-ohio","cleveland-ohio"],"enrichment":{"headline":"Phase 1 / Phase 2: testing SA53-OS (phase 1) for Solid Tumor","inPlainEnglish":"The objective of this study is to assess the safety, how well it works, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors. The study is comprised of 2 parts: Part 1 called dose escalation, and Part 2a called dose expansion.","whoItsFor":["Ages 18 Years to any","Tumor characteristics of participants in Phase 1","Tumor p53 wild-type","Tumor characteristics of participants in Phase 2a","Cohort A: Tumor p53 wild-type with histologically confirmed diagnosis of advanced or metastatic DD LPS (and MDM2 amplification); OR Cohort B: Tumor p53 wild-type in other solid tumor","Measurable disease by RECIST 1.1","18 years old or older","Resolution of clinically relevant toxicity-related to prior anticancer therapies prior to receipt of study treatment to Grade 1 or less"],"whoShouldSkip":["Anticipated need for major surgery and/or localized palliative radiation within the next 6 weeks","Known HIV infection or active hepatitis B or C infection","Thrombotic event requiring active and ongoing anticoagulation within the last 6 months prior to study treatment","Myocardial infarction within the last 6 months prior to study treatment","Significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, congestive heart failure New York Heart Association (NYHA) Class III or IV related to primary cardiac disease, uncontrolled ischemic or severe vascular heart disease","A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)","Known bleeding disorder (e.g., hemophilia, von Willebrand disease)"],"whatHappens":"If you join, the listed intervention(s) are SA53-OS (phase 1), or SA53-OS (phase 2). The registry lists allocation as randomized. The objective of this study is to assess the safety, how well it works, and pharmacokinetics of SA53-OS in adult participants with refractory solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 55 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.589Z"},{"nctId":"NCT06579443","title":"Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study","officialTitle":"Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospitals Coventry and Warwickshire NHS Trust","sponsorClass":"OTHER","summary":"To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.","conditions":["Inflammatory Bowel Diseases","Crohn Disease","Ulcerative Colitis"],"keywords":["Robotic IBD surgery","Laparoscopic IBD surgery"],"interventions":[],"enrollment":100,"startDate":"2024-07-12","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18 years or over\n* Undergoing IBD surgery using MIS (minimally invasive surgery) techniques\n* Histological/radiological evidence of inflammatory bowel disease\n\nExclusion Criteria:\n\n* Planned open surgical approach\n* Lacks capacity to provide informed consent","locations":[{"facility":"University Hospitals Coventry & Warwickshire (UHCW) NHS Trust","city":"Coventry","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Newcastle Hospitals NHS Foundation Trust","city":"Newcastle upon Tyne","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals NHS Foundation Trust","city":"Oxford","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"London North West University Healthcare NHS Trust","city":"Harrow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's and St Thomas NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chelsea and Westminster Hospital NHS Foundation","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Manreet Thind","phone":"02476966581","email":"Riddlestudyoffice@uchw.nhs.uk"}],"primaryOutcomes":["To see if robotic surgery is technically feasible for patients with inflammatory bowel disease measured during intra-operative procedure that includes: estimated blood loss in mL.","Port placement using position of ports on the abdomen marked in a diagram during surgical procedure.","Docking of robotic arm in robotic surgery using number of times the docking was done with start and end docking time in HH:MM.","Operative time using time of surgery performed in HH:MM."],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["coventry-united-kingdom","newcastle-upon-tyne-united-kingdom","oxford-united-kingdom","harrow-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Robotic Inflammatory Bowel Disease Development, Learning and Efficacy Study","inPlainEnglish":"To determine if robotic surgery can be performed for inflammatory bowel disease (IBD) patients, to ascertain the optimal robotic set up for multi-quadrant IBD operations and evaluate clinical outcomes in robotic compared to laparoscopic surgery.","whoItsFor":["Ages 18 Years to any","Aged 18 years or over","Undergoing IBD surgery using MIS (minimally invasive surgery) techniques","Histological/radiological evidence of inflammatory bowel disease"],"whoShouldSkip":["Planned open surgical approach"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.221Z"},{"nctId":"NCT06579469","title":"Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy","officialTitle":"Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"St. Jude Children's Research Hospital","sponsorClass":"OTHER","summary":"This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.","conditions":["B-ALL","Hematologic Malignancy","Solid Tumor"],"keywords":["CAR T cell infusion","Late Effects"],"interventions":[],"enrollment":100,"startDate":"2026-01-20","completionDate":"2029-01","sex":"ALL","minAge":null,"maxAge":"30 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have received an initial systemically-administered CAR T cell infusion for an oncologic diagnosis within the last 1-3 months (+/- 14 days).\n\n  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.\n* Age ≤ 30 years at CAR T cell infusion.\n\nExclusion Criteria:\n\n* Active malignancy other than the disease under study.\n* Planned consolidative HSCT within 3 months post CAR T cell infusion.\n* Received or planned additional disease directed therapy post CAR T cell infusion.\n* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.","locations":[{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hospital of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Primary Children's Hospital","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Childrens Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Wisconsin.","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rebecca Epperly, MD","phone":"888-226-4343","email":"referralinfo@stjude.org"}],"primaryOutcomes":["Presence of bone marrow dysfunction (BMD)","Occurrence of clinically significant infections","Presence of persistent ICANS"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["car-t"],"locationSlugs":["los-angeles-california","aurora-colorado","philadelphia-pennsylvania","memphis-tennessee","salt-lake-city-utah","seattle-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy","inPlainEnglish":"This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and/or have damage to the nervous system.","whoItsFor":["Ages any to 30 Years","Participants must have received an initial systemically-administered CAR T cell infusion for an oncologic diagnosis within the last 1-3 months (+/- 14 days)","Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT","Age ≤ 30 years at CAR T cell infusion"],"whoShouldSkip":["Active malignancy other than the disease under study","Planned consolidative HSCT within 3 months post CAR T cell infusion","Received or planned additional disease directed therapy post CAR T cell infusion"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.409Z"},{"nctId":"NCT06580314","title":"Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer","officialTitle":"A Phase III Trial of One vs. Two Years of Maintenance Olaparib, With or Without Bevacizumab, in Patients With BRCA1/2 Mutated or Homologous Recombination Deficient (HRD+) Ovarian Cancer Following Response to First Line Platinum-Based Chemotherapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NRG Oncology","sponsorClass":"OTHER","summary":"This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.","conditions":["Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube High Grade Serous Adenocarcinoma","Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor","FIGO Stage III Ovarian Cancer 2014","FIGO Stage IV Ovarian Cancer 2014","Ovarian Carcinoma","Ovarian Carcinosarcoma","Ovarian High Grade Endometrioid Adenocarcinoma","Ovarian High Grade Serous Adenocarcinoma","Primary Peritoneal Carcinosarcoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal High Grade Serous Adenocarcinoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Olaparib"}],"enrollment":880,"startDate":"2025-03-12","completionDate":"2034-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:\n\n  * High grade serous\n  * High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)\n  * Carcinosarcoma (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated), and/or\n  * Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)\n  * Submission of pathology report is required\n  * Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer\n* Patients must have:\n\n  * Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration)\n\n    * Submission of testing report is required. OR\n  * BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, Clinical Laboratory Improvement Act (CLIA)-certified laboratory (e.g., Myriad MyChoice©)\n\n    * Submission of testing report is required\n* Patient must have undergone cytoreductive surgery (primary or interval)\n* Patients must have completed first line platinum-based therapy prior to registration:\n\n  * Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated\n\n    * For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy\n  * Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle\n  * Patients must not have received an investigational agent during their first line course of chemotherapy\n* Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy)\n* Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy\n* Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent)\n* No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n* Platelets ≥ 100,000 cells/mm\\^3\n* Hemoglobin ≥ 9 g/dl\n* Creatinine clearance (CrCL) of \\> 30 mL/min by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parental antibiotic(s)\n* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube\n* No current inability to swallow orally administered medication\n* No history of myelodysplastic syndrome and/or acute myeloid leukemia\n* No history of allogeneic bone marrow transplant\n* No concomitant use of strong or moderate CYP3A inducers\n* No known hypersensitivity to olaparib or any of the excipients of the product","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairbanks Memorial Hospital","city":"Fairbanks","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CARTI Cancer Center","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Rogers","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Deer Valley Medical Center","city":"Antioch","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Hope Medical Oncology - Arroyo Grande","city":"Arroyo Grande","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Auburn Faith Hospital","city":"Auburn","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Cancer Centers Radiation Oncology Services-Auburn","city":"Auburn","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Bellflower","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alta Bates Summit Medical Center-Herrick Campus","city":"Berkeley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Joseph Medical Center/Disney Family Cancer Center","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mills-Peninsula Medical Center","city":"Burlingame","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Cancer Centers Radiation Oncology Services-Cameron Park","city":"Cameron Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Carmichael","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy San Juan Medical Center","city":"Carmichael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eden Hospital Medical Center","city":"Castro Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Davis Hospital","city":"Davis","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center - Elk Grove","city":"Elk Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Center Emeryville","city":"Emeryville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fresno Cancer Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fresno","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente South Bay","city":"Harbor City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente West Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center","city":"Merced","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Medical Center","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Modesto","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Camino Division","city":"Mountain View","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation-Gynecologic Oncology","city":"Mountain View","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Queen of The Valley","city":"Napa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Cancer Research Consortium","city":"Novato","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health at SMSHCC","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Oakland-Broadway","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation Health Care","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Cancer Institute Palo Alto","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente - Panorama City","city":"Panorama City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntington Memorial Hospital","city":"Pasadena","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Rancho Cordova Cancer Center","city":"Rancho Cordova","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Marshall Medical Offices","city":"Redwood City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser 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3: testing Bevacizumab for Fallopian Tube Endometrioid Adenocarcinoma","inPlainEnglish":"This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Patients with newly diagnosed, pathologically confirmed, Federation of Gynecology and Obstetrics (FIGO) stage III or IV ovarian cancer of the following types:","High grade endometrioid (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)","Carcinosarcoma (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated), and/or","Other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic), (excluding tumors that are known mismatch repair deficient/microsatellite instability high (MMR-D/MSI-H) or POLE ultramutated)","Submission of pathology report is required","Ovarian cancer = ovarian, fallopian, or primary peritoneal cancer","Patients must have:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Bevacizumab, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 880 people at 709 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.171Z"},{"nctId":"NCT06581328","title":"A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting","officialTitle":"A Phase 4 Study Evaluating Moderate to Severely Active Ulcerative Colitis or Crohn's Disease and the Use of Vedolizumab Subcutaneous Within a Community Setting","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"Ulcerative Colitis (UC) and Crohn's Disease (CD) are long-term conditions in the gut that can cause diarrhea, swelling (inflammation), bleeding from the anus, and belly pain. The main aim of this study is to check for how many participants with UC and CD signs and symptoms disappear after 3.5 months (14 weeks) of treatment with Vedolizumab (this is called remission).\n\nParticipants will be treated with Vedolizumab for approximately 1 year (50 weeks). During the first 1.5 months (6 weeks), participants will receive Vedolizumab as an infusion in the vein (called intravenously). After this, participants will receive Vedolizumab as an injection under the skin (called subcutaneously) for the rest of the treatment. Participants for whom the treatment does not seem to work well after 3.5 months (14 weeks) will stop treatment with Vedolizumab and can change to another treatment and also there will be additional required visits at 6 months (26 weeks) and at 1 year (52 weeks). All participants will be checked again 4.5 months (18 weeks) after their last treatment with Vedolizumab.\n\nDuring the study, participants will visit their study clinic several times.","conditions":["Ulcerative Colitis","Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Vedolizumab IV"},{"type":"DRUG","name":"Vedolizumab SC"}],"enrollment":200,"startDate":"2025-03-27","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nTo be eligible to participate in this study, participants must meet all the following criteria:\n\n1. In the investigator's opinion, the participant can understand and comply with protocol requirements.\n2. The participant signs and dates an electronic informed consent form (ICF) and any required privacy authorization prior to any study procedures.\n3. The participant is 18 to 80 years of age at the time of signing the ICF.\n4. The participant's immunization is up to date per vedolizumab US prescribing information (USPI).\n5. Participants must meet the contraception recommendations.\n6. The participant has a diagnosis of moderate to severely active UC or CD defined by the following:\n\n   1. CD: A Crohn's Disease Activity Index (CDAI) score of 220 to 450 and a SES-CD \\>=6 (\\>=4 if isolated ileal disease) at screening OR\n   2. UC: A complete Mayo score (MS) of 6 to 12 with endoscopy sub-score of 2 to 3 at screening.\n7. UC or CD diagnosis established prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report.\n8. Demonstrated an inadequate response to, loss of response to, or intolerance of at least one of the following agents: corticosteroids, immunomodulators, and/or advanced therapy.\n\nExclusion Criteria\n\nParticipants who meet any of the following exclusion criteria will be excluded from participation in this study:\n\n1. Received approved or investigational anti-integrin antibodies (i.e., vedolizumab, natalizumab, efalizumab, etrolizumab, abrilumab \\[AMG 181\\]) at any time prior to screening.\n2. Failed (primary or secondary nonresponse) on more than 2 prior advanced treatments.\n3. Use of corticosteroid enemas/suppositories within 2 weeks prior to screening (for UC and CD).\n4. In the investigator's opinion, the participant meets any contraindication, warnings and precautions, drug interactions, or special population considerations per the vedolizumab USPI, or has a medical history or known allergy, hypersensitivity, or intolerance to vedolizumab or its excipients.\n5. Received any investigational biologic therapy \\<= 6 months prior to screening.\n6. The participant has received an advanced treatment for an approved indication other than CD or UC within 60 days prior to screening.\n\n   a. Advanced therapies include tumor necrosis factor (TNF) inhibitors, 12/23 antagonists, janus kinase (JAK) inhibitors, and sphingosine-1-phosphate (S1P) receptor modulators.\n7. The participant has any evidence of an active infection during screening.\n8. Ileostomy, colostomy, severe or symptomatic stenosis of the intestine, or short bowel syndrome.\n9. A surgical procedure requiring general anesthesia within 30 days prior to screening or planned or possible major surgery during the study period.\n10. History of malignancy, except for adequately treated nonmetastatic basal cell skin cancer; adequately treated squamous cell skin cancer that has not recurred for at least 1 year before screening; and adequately treated cervical carcinoma in situ that has not recurred for at least 3 years before screening. Participants with a remote history of malignancy (e.g., \\>10 years since completion of curative therapy without recurrence) will be considered based on the nature of the malignancy and therapy received; this must be discussed with the sponsor on a case-by-case basis before enrollment.\n11. Participants with any unstable or uncontrolled cardiovascular conditions, moderate to severe heart failure (New York Heart Association Class III or IV), pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological, or other medical disorders that, in the investigator's opinion, would confound the study results or compromise participant safety.\n12. Participants with active cerebral or meningeal disease, signs or symptoms or a history of progressive multifocal leukoencephalopathy (PML), or any other major neurological disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.\n13. Participant is not on a stable dose of corticosteroid.\n14. Has any of the following laboratory abnormalities during the screening period: (a) hemoglobin \\<8 grams per deciliter (g/dL); (b) white blood cell (WBC) count \\<3.0 × 10\\^9 per liter (L); (c) lymphocyte count \\<0.5 × 10\\^9/L; (d) platelet count \\<100 × 10\\^9/L or \\>1200 × 10\\^9/L; (e) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3.0 × the upper limit of normal (ULN); or (f) alkaline phosphatase (ALP) \\>1.5 × ULN. Historical laboratory data may be used for screening if available in the participant's electronic health record (EHR) within 6 weeks before screening.","locations":[{"facility":"Gastro Health","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East View Medical Research","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Gastro Care","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Research Institute LLC","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance- Sun City","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UAMS Health Gastroenterology Clinic","city":"Little Rock","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Gastroenterology and Liver Institute","city":"Escondido","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Gastroenterology","city":"Murrieta","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"United Clinical Research Institute","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive Health Institute","city":"Newport Beach","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Knowledge Research Center","city":"Orange","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Medical Associates Research Group, Inc.","city":"San Diego","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Peak Gastroenterology Associates","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Endocopy Centers LLC","city":"Littleton","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Access Research Institute","city":"Brooksville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Florida","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Doral Medical Research, LLC","city":"Hialeah","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Digestive and Liver Center of Florida, P.A.","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Health Research - Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endoscopic Research, Inc.","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health-Orlando Regional Medical Center","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive and Liver Center of Florida","city":"Orlando","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Gastro Health Research - Pensacola","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Central Gastroenterology d/b/a Gastro Florida","city":"Pinellas Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive Healthcare of Georgia","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AGA GA Research LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Gastroenterology, P.C.","city":"Decatur","state":"Georgia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Yapp, Rockford M.D. (Private Practice)","city":"Downers Grove","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Glenview","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology and Internal Medicine Specialists, SC","city":"Lake Barrington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban 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Ospedaliere Umberto I di Ancona","city":"Ancona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro di riferimento Oncologico","city":"Aviano (PN)","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Scientifico Romagnolo","city":"Meldola (FC)","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Grande Ospedale Metropolitano Niguarda","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Università degli Studi della Campania Luigi Vanvitelli","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Campus Bio-medico","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center Hospital","city":"Aichi, Nagoya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Chiba, Kashiwa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyushu University Hospital","city":"Fukuoka, Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital","city":"Hokkaido, Sapporo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital","city":"Okayama, Okayama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka International Cancer Institute","city":"Osaka, Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Shizuoka, Sunto-gun","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Tokyo, Chuo-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Foundation for Cancer Research","city":"Tokyo, Koto-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboud Universitair Medisch Centrum","city":"Nijmegen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo Universitetssykehus HF, Radiumhospitalet","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pan American Center for Oncology Trials, LLC","city":"Rio Piedras","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario A Coruña","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Germans Trias i Pujol","city":"Badalona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital del Mar","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Duran i Reynals","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Universidad de Navarra - Madrid","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Universidad de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico De Valencia (INCLIVA)","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham","city":"Birmingham","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ninewells Hospital & Medical School","city":"Dundee","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Christie","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-0127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Proportion of patients with objective response (OR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["anchorage-alaska","tucson-arizona","beverly-hills-california","la-jolla-california","los-angeles-california","new-haven-connecticut","tamarac-florida","arlington-heights-illinois","indianapolis-indiana","columbia-maryland","detroit-michigan","albuquerque-new-mexico","new-york-new-york","maumee-ohio","wynnewood-pennsylvania","dallas-texas","houston-texas","plano-texas","fairfax-virginia","macquarie-park-australia","st-leonards-australia","woolloongabba-australia","adelaide-australia","subiaco-australia","brussels-belgium","edegem-belgium","edmonton-canada","vancouver-canada","toronto-canada","montreal-canada","beijing-china","changsha-china","hangzhou-china","hefei-china","nanchang-china","nanjing-china","shanghai-china","wuhan-china","zhengzhou-china","bordeaux-france","dijon-france","lyon-france","marseille-france","poitiers-france","villejuif-france","berlin-germany","giessen-germany","hamburg-germany","leipzig-germany","mannheim-germany","m-nchen-germany","ancona-italy","aviano-pn-italy","meldola-fc-italy","milan-italy","naples-italy","rome-italy","aichi-nagoya-japan","chiba-kashiwa-japan","fukuoka-fukuoka-japan","hokkaido-sapporo-japan","okayama-okayama-japan","osaka-osaka-japan","shizuoka-sunto-gun-japan","tokyo-chuo-ku-japan","tokyo-koto-ku-japan","amsterdam-netherlands","nijmegen-netherlands","oslo-norway","rio-piedras-puerto-rico","singapore-singapore","seoul-south-korea","a-coru-a-spain","badalona-spain","barcelona-spain","madrid-spain","pamplona-spain","seville-spain","valencia-spain","birmingham-united-kingdom","dundee-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Zongertinib for Solid Tumours","inPlainEnglish":"This is a study for people with advanced cancer for whom previous treatment was not successful. Adults aged 18 and over with advanced cancer with HER2 alterations can join the study.","whoItsFor":["Ages 18 Years to any","Patients aged ≥18 years","Documented Human epidermal growth factor receptor 2 (HER2)-positive status or known activating HER2 mutations (by local testing)","Histologically or cytologically confirmed locally advanced, unresectable, or metastatic solid tumours","Disease progression following prior treatment in the metastatic setting (including treatment with antibody-drug conjugates (ADCs)) and no suitable standard of care treatment options","Availability of archival tumour tissue sample to confirm HER2 status","Presence of ≥1 measurable lesion outside the central nervous system (CNS) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (investigator assessed)","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Further who can join apply"],"whoShouldSkip":["Diagnosis of HER2-positive (overexpressed/amplified) metastatic breast cancer","Diagnosis of HER2-mutant non-small cell lung cancer (NSCLC)","Previous treatment with any HER2 tyrosine kinase inhibitors (TKIs)","Uncontrolled or symptomatic brain or subdural metastases during screening","Known diagnosis of leptomeningeal disease","Intake of restricted medications or any drug considered likely to interfere with the trial being conducted in a safe mannerFurther"],"whatHappens":"If you join, the listed intervention(s) are Zongertinib. The registry lists allocation as na. This is a study for people with advanced cancer for whom previous treatment was not successful.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 588 people at 93 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.130Z"},{"nctId":"NCT06582771","title":"A Study of Sotorasib in People With Non-Small Cell Lung Cancer","officialTitle":"A Phase 2 Study of First-line Sotorasib for Patients With Advanced KRAS G12C-mutant Non-small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a \"first-line therapy\" since their cancer became advanced.)","conditions":["Non Small Lung Cancer"],"keywords":["Sotorasib","advanced KRAS G12C-mutant","24-049"],"interventions":[{"type":"DRUG","name":"Sotorasib"}],"enrollment":39,"startDate":"2024-08-30","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent\n* Biopsy-proven metastatic or recurrent non-small cell lung cancer\n* KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing\n* No prior therapy in the advanced setting\n* Measurable disease per RECIST 1.1\n* Karnofsky performance status (KPS) ≥ 70%\n* Age ≥ 18\n* Adequate organ function\n\n  * Hemoglobin ≥ 9\\^9 g/dL\n  * Platelets ≥ 75 x 10\\^9/L\n  * Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9/L\n  * AST \\< 3 x ULN (if liver metastases are present, \\< 5 x ULN)\n  * ALT \\< 3 x ULN (if liver metastases are present, \\< 5 x ULN)\n  * Alkaline phosphatase \\< 2 x ULN (if liver or bone metastases are present,\\< 3 xULN)\n  * Total bilirubin ≤1.5 x ULN; subjects with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits\n  * Serum creatinine \\< 1.5 x ULN or if available, calculated or measured creatinine clearance \\> 30 mL/min/1.73 m\\^2\n\nIn addition, patients must:\n\n* Be willing to undergo pre-treatment and day 7-21 on-treatment tumor biopsies\n* Decline first-line chemotherapy and/or anti-PD-(L)1 therapy, or previously have experienced disease progression after adjuvant or consolidation chemotherapy or anti-PD-(L)1 therapy for early stage (I-III) NSCLC\n\nBefore enrollment, a woman must be either:\n\n* Not of childbearing potential: premenarchal; postmenopausal (\\>45 years of age with amenorrhea for at least 12 months); post-hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n* Of childbearing potential and practicing effective method(s) of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies, as described below:\n\n  * Practicing true abstinence (when this is in line with the preferred and usual lifestyle of the subject), which is defined as refraining from heterosexual intercourse during the entire period of the study, including up to 6 months after the last dose of study drug is given. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not consider an acceptable contraceptive method\n* Have a sole partner who is vasectomized\n* Practicing 2 methods of contraception, including one highly effective method (i.e., established use of oral, injected or implanted hormonal methods of contraception; placement of intrauterine device \\[IUD\\] or intrauterine system \\[IUS\\], AND, a second method (e.g., condom with spermicidal foam/gel/film/cream/suppository or collusive cap \\[diaphragm or cervical/vault caps\\] with spermicidal foam/gel/film/ cream/suppository) Subjects must agree to continue contraception throughout the study and continuing through at least 7 days after the last dose of study drug\n* NOTE: If the childbearing potential changes after start of the study (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin a highly effective method of birth control, as described above.\n* A woman of childbearing potential must have a negative serum (b-human chorionic gonadotropin \\[b-hCG\\]) at Screening\n* A man who is sexually active with a woman of childbearing potential must agree to use a condom with spermicidal foam/gel/film/cream/suppository and his partner must also be practicing a highly effective method of contraception (i.e., established use of oral, injected or implanted hormonal methods of required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug.\n\ncontraception; placement of an intrauterine device \\[IUD\\] or intrauterine system \\[IUS\\]). If the subject is vasectomized, he must still use a condom (with or without spermicide), but his female partner is not required to use contraception. The subject must also not donate sperm during the study and for at least 7 days after receiving the last dose of study drug.\n\nExclusion Criteria:\n\n* Symptomatic brain metastases\n* Any radiotherapy within 1 week of starting treatment on protocol\n* Any major surgery within 1 week of starting treatment on protocol\n* Exposure to prior adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy for stage I-III disease within 12 weeks of start of initiation of sotorasib\n* Unresolved \\> grade 1 toxicity from any previous treatment\n* Prior history of \\> grade 1 pneumonitis from any previous treatment\n* Congestive heart failure defined as New York Heart Association (NYHA) Class III-IV or hospitalization for congestive heart failure (any NYHA class) within 6 months of study Day 1 Gastrointestinal (GI) tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, uncontrolled inflammatory GI disease (eg, Crohn's disease, ulcerative colitis)\n* Positive hepatitis B (hepatitis B virus \\[HBV\\]) surface antigen (HBsAg) o NOTE: Subjects with a prior history of HBV demonstrated by positive hepatitis B core antibody are eligible if they have at Screening 1) a negative HBsAg and 2) a HBV DNA (viral load) below the lower limit of quantification, per local testing. Subjects with a positive HBsAg due to recent vaccination are eligible if HBV DNA (viral load) is below the lower limit of quantification, per local testing.\n\nPositive hepatitis C antibody (anti-HCV)\n\no NOTE: Subjects with a prior history of HCV, who have completed antiviral treatment and have subsequently documented HCV RNA below the lower limit of quantification per local testing are eligible.\n\n* Other clinically active or chronic liver disease\n* Currently enrolled in another investigational device or drug study, or less than 28 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)\n* Use of known cytochrome P450 (CYP) 3A4 sensitive substrates (with a narrow therapeutic window), within 14 days or 5 half-lives (whichever is longer) of the drug or its major active metabolite, whichever is longer, prior to study day 1 that was not reviewed and approved by the principal investigator\n* Use of strong inducers of CYP3A4 within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the principal investigator\n* Use of P-gp substrates within 14 days or 5 half-lives (whichever is longer) prior to study day 1 that was not reviewed and approved by the principal investigator\n* Patients who do not agree to pre-treatment and on-treatment tumor biopsies during the informed consent process will be excluded from the study. Patients who agree to pre-treatment and on-treatment tumor biopsies, but in whom either biopsy is ultimately deemed unsafe by the investigators/treatment team, will be allowed to participate in the study and will remain evaluable for the clinical endpoints.","locations":[{"facility":"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gregory Riely, MD, PhD","phone":"646-608-3913","email":"rielyg@mskcc.org"},{"name":"Kathryn Arbour, MD","phone":"646-608-3792","email":""}],"primaryOutcomes":["Response to therapy"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york"],"enrichment":{"headline":"Phase 2: testing Sotorasib for Non Small Lung Cancer","inPlainEnglish":"The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced. (Participants have not received a \"first-line therapy\" since their cancer became advanced.)","whoItsFor":["Ages 18 Years to any","Biopsy-proven metastatic or recurrent non-small cell lung cancer","KRAS G12C mutation on prior tumor biopsy or cell-free DNA (cfDNA) testing","No prior therapy in the advanced setting","Measurable disease per RECIST 1.1","Karnofsky performance status (KPS) ≥ 70%","Adequate organ function","Hemoglobin ≥ 9\\^9 g/dL"],"whoShouldSkip":["Symptomatic brain metastases","Any radiotherapy within 1 week of starting treatment on protocol","Any major surgery within 1 week of starting treatment on protocol","Exposure to prior adjuvant or consolidation anti-PD-1 or PD-(L)1 therapy for stage I-III disease within 12 weeks of start of initiation of sotorasib","Unresolved \\> grade 1 toxicity from any previous treatment","Prior history of \\> grade 1 pneumonitis from any previous treatment","Positive hepatitis C antibody (anti-HCV)"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib. The registry lists allocation as na. The researchers are doing this study to see if sotorasib is a safe and effective treatment for people with advanced non-small cell lung cancer (NSCLC) with a KRAS G12C mutation who have not received treatment for their cancer since it became advanced.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 39 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.969Z"},{"nctId":"NCT06585787","title":"A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.","conditions":["Alzheimer Disease"],"keywords":["Alzheimer's Disease","AD","ADEPT4","ADEPT-4","KarXT","Psychosis"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"DRUG","name":"Placebo"}],"enrollment":406,"startDate":"2024-09-26","completionDate":"2026-11-24","sex":"ALL","minAge":"55 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).\n* Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.\n* Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.\n* Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).\n\nExclusion Criteria\n\n\\- Patients will not be able to participate if they have:\n\ni) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.\n\nii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.\n\niii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.\n\n\\* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 1227","city":"Chandler","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Gilbert Neurology Partners - PLLC - Avacare","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner Alzheimer's Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 1220","city":"Scottsdale","state":"Arizona","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Advanced Research Center, Inc.","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group (IPMG)-Chino","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 1230","city":"Long Beach","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 1219","city":"Los Angeles","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 1001","city":"Orange","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 1228","city":"Orange","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 1043","city":"Pasadena","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 1213","city":"Rancho Cucamonga","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Connecticut Health Center","city":"Farmington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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The registry lists allocation as randomized. This study wants to measure the safety and how well it works of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 406 people at 295 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.047Z"},{"nctId":"NCT06586957","title":"A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors","officialTitle":"A Phase 1, First-in-human, Open-label Study to Evaluate the Safety, Tolerability, PK, and Preliminary Anti-tumor Activity of the Novel Oral CDK2 Degrader NKT3964 in Adults With Advanced/Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"NiKang Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of the Monotherapy Dose Escalation phase (Part 1) of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors.\n\nThe goal of the Monotherapy Expansion phase of the study (Part 2) is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).\n\nThe goal of the Combination Dose Escalation phase (Part 3) of the study is to identify the RDE of NKT3964 in combination with chemotherapy in adult subjects with advanced/metastatic endometrial cancer. The goal of the Combination Expansion phase of the study (Part 4) is to evaluate the preliminary anti-tumor activity of NKT3964 in combination with chemotherapy at the RDE based on ORR.","conditions":["Solid Tumor","Advanced Solid Tumor","Solid Tumor, Adult","Metastatic Tumor","Ovarian Cancer","Ovarian Neoplasms","Ovarian Carcinoma","Metastatic Ovarian Carcinoma","Endometrial Neoplasms","Endometrial Diseases","Metastatic Endometrial Cancer","Triple Negative Breast Cancer","Metastatic Endometrial Carcinoma","Advanced Endometrial Carcinoma","Advanced Ovarian Carcinoma","Gastric Cancer","Advanced Gastric Carcinoma","Metastatic Gastric Cancer","Metastatic Gastric Carcinoma","Small Cell Lung Cancer","Small Cell Lung Carcinoma","Triple Negative Breast Neoplasms","Platinum-resistant Ovarian Cancer","Platinum-refractory Ovarian Carcinoma","CCNE1 Amplification","Hormone Receptor Negative Breast Carcinoma","Human Epidermal Growth Factor 2 Negative Carcinoma of Breast","Progesterone-receptor-positive Breast Cancer"],"keywords":["CDK 2 Inhibitor","CDK 4 Inhibitor","CDK 6 Inhibitor","CDK2 Degrader","Protein Degrader","PROTAC"],"interventions":[{"type":"DRUG","name":"NKT3964"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Doxorubicin"}],"enrollment":238,"startDate":"2024-09-19","completionDate":"2029-01","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Must have a pathologically confirmed advanced and unresectable or metastatic solid tumor listed below with documented disease progression on last standard treatment. Part 1 Monotherapy Dose Escalation (including Food Effect Sub-study): subjects must be refractory to, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n\nPart 1 Monotherapy Dose Escalation:\n\n1. Ovarian cancer\n2. Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)\n3. Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification\n4. Small cell lung cancer (SCLC)\n5. Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)\n6. HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])\n7. Other solid tumors with CCNE1 amplification\n\n   * \\- Part 2 Monotherapy Dose Expansion:\n   * Part 2A: HR+ and HER2- breast cancer that is locally advanced and unresectable (Stage III) or metastatic (Stage IV); previously treated with ≥1 line of standard of care (SOC) including CDK4/6 inhibitor plus ET and not suitable for further ET. Subjects must have progressed after receiving therapy for ≥3 months in the metastatic setting or for ≥6 months in the adjuvant setting. Subjects must have received ≤2 lines of systemic cytotoxic therapy (chemotherapy or cytotoxic antibody drug conjugate \\[ADC\\]) in the metastatic setting..\n   * Part 2B: Advanced platinum-based-chemotherapy resistant or refractory epithelial ovarian/fallopian/primary peritoneal carcinoma or clear cell ovarian cancer (defined as recurrence ≤6 months after completing platinum-based regimen) with progression on at least one platinum containing therapy and previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease and with CCNE1 amplification.\n   * Part 2C: Advanced unresectable or metastatic gastric, GEJ or esophageal adenocarcinoma with progression on at least one systemic therapy and previously treated with ≤3 prior lines of systemic therapy administered for advanced/metastatic disease, with CCNE1 amplification.\n   * Part 2D: Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor.\n   * Part 2E: Advanced/recurrent uterine carcinosarcoma previously treated with 1 prior platinum-based chemotherapy regimen and ≤3 prior lines of systemic therapy. Prior bevacizumab or PARP inhibitors are allowed and must be at least 3 weeks prior to the start of study drug.\n   * -Part 3 Combination Dose Escalation:\n   * Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)\n   * -Part 4 Combination Dose Expansion:\n   * Advanced endometrial adenocarcinoma or uterine papillary serous carcinoma previously treated with ≤4 prior lines of systemic therapy administered for advanced/metastatic disease with CCNE1 amplification. (Subjects with clear cell carcinoma or uterine serous carcinoma histology may be considered regardless of CCNE1 status after discussion and approval from the Sponsor)\n   * Have adequate organ function\n   * Subjects with female reproductive organs must be surgically sterile, post-menopausal, or must be willing to use highly effective method(s) of contraception\n   * Ability to swallow oral medications.\n   * Consent to provide archived tumor tissues and paired tumor biopsy at pretreatment\n\nExclusion Criteria:\n\n* Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy.\n* History of another malignancy with exceptions\n* History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis.\n* Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)\n* Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment\n* Known active CNS metastases and/or carcinomatous meningitis\n* Active interstitial lung disease currently requiring treatment\n* History of uveitis, retinopathy or other clinically significant retinal disease\n* Active or chronic corneal disorders, other active ocular conditions requiring ongoing therapy, or any clinically significant corneal disease\n* Active wound healing from major surgery within 1 month or minor surgery within 10 days before the first dose of NKT3964.\n* Known human immunodeficiency virus (HIV), active hepatitis B or C infection\n* Prior investigative treatment with a selective or nonselective CDK2 inhibitor or degrader\n* Childs-Pugh class B or C cirrhosis or any other clinically significant liver disorder\n* Palliative radiation therapy within 14 days or other radiation therapy within 4 weeks prior to C1D1\n* Prior severe hypersensitivity reaction to paclitaxel or other drugs formulated in Polyoxyl 35 Castor Oil (Cohort 3A and 4A only) or severe hypersensitivity reaction to doxorubicin or any other component of the product, other anthracyclines or anthracenediones (Cohort 3B and 4B).\n* \\- For subjects in Cohort 3B or 4B only:\n* Left ventricular ejection fraction (LVEF) \\<50% as measured by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 4 weeks prior to first dose\n* Active cardiac conditions including myocarditis, pericarditis, or clinically significant valvular heart disease\n* Known elevated cardiac biomarkers at baseline\n* History of anthracycline-related cardiomyopathy regardless of recovery\n* Cumulative lifetime exposure to doxorubicin, including planned doxorubicin in Part 3b or Part 4b, exceeding 450 mg/m2","locations":[{"facility":"University of Arkansas Medical School","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California - Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF","city":"San Francisco","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"SCRI at HealthOne","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists & Research Institute","city":"Lake Mary","state":"Florida","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"AdventHealth Cancer Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas","city":"Fairway","state":"Kansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack UMC","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sidney Kimmell Cancer Center - Jefferson Health","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute (SCRI)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chung-Ang University Gwangmyeong Hospital","city":"Gwangmyeong","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei Cancer Center / Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sponsor Contact","phone":"(302) 596-8654","email":"clinicaltrials@nikangtx.com"}],"primaryOutcomes":["Number of Participants with Dose Limiting Toxicity (DLT) events","Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","ovarian-cancer","stomach-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","los-angeles-california","san-francisco-california","denver-colorado","lake-mary-florida","orlando-florida","atlanta-georgia","augusta-georgia","fairway-kansas","boston-massachusetts","hackensack-new-jersey","philadelphia-pennsylvania","pittsburgh-pennsylvania","nashville-tennessee","austin-texas","dallas-texas","salt-lake-city-utah","charlottesville-virginia","fairfax-virginia","gwangmyeong-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing NKT3964 for Solid Tumor","inPlainEnglish":"The goal of the this drug alone Dose Escalation phase (Part 1) of the study is to measure the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the this drug alone Expansion phase of the study (Part 2) is to measure the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).","whoItsFor":["Ages 19 Years to any","Part 1 this drug alone Dose Escalation:","Endometrial cancer (only endometrioid subtype will require CCNE1 amplification)","Gastric, gastroesophageal junction (GEJ) or esophageal adenocarcinoma with CCNE1 amplification","Small cell lung cancer (SCLC)","Triple-negative breast cancer (TNBC; HER2, estrogen receptor and progesterone receptor negative)","HR+ (includes estrogen-receptor or progesterone-receptor) and HER2- breast cancer (must have progressed following treatment with a CDK4/6 inhibitor, and is not suitable for endocrine therapy \\[ET\\])","Other solid tumors with CCNE1 amplification"],"whoShouldSkip":["Locally advanced solid tumor that is a candidate for curative treatment through radical surgery and/or radiotherapy, or chemotherapy","History of another malignancy with exceptions","History of lymphohistiocytic or lymphoid hyperplasia; hemophagocytic lymphohistiocytosis","Failed to recover from effects of prior anticancer treatment therapy to baseline or Grade ≤ 1 severity (per CTCAE)","Clinically significant cardiovascular event within 6 months prior to start of NKT3964 treatment","Known active CNS metastases and/or carcinomatous meningitis","Active interstitial lung disease currently requiring treatment"],"whatHappens":"If you join, the listed intervention(s) are NKT3964, Paclitaxel, or Doxorubicin. The registry lists allocation as randomized. The goal of the this drug alone Dose Escalation phase (Part 1) of the study is to measure the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 238 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.976Z"},{"nctId":"NCT06588634","title":"The PERSEVERE Study","officialTitle":"The PERSEVERE Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Inari Medical","sponsorClass":"INDUSTRY","summary":"Randomized Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care","conditions":["Pulmonary Embolism","Pulmonary Thromboembolism"],"keywords":["PE","Pulmonary Embolism","FlowTriever","CDT","Catheter Directed Thrombolysis","Anticoagulation"],"interventions":[{"type":"DEVICE","name":"FlowTriever System"},{"type":"PROCEDURE","name":"Standard of Care"}],"enrollment":200,"startDate":"2024-12-16","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age at enrollment ≥18 years\n2. Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery\n3. High-risk class of acute PE\n4. RV dysfunction, as defined RV/LV ratio ≥1.0\n5. Willing and able to provide informed consent, or if unable, through a Legal Authorized Representative, with permitting research without prior consent as a third option (for Europe and UK sites only), provided compliance with IRB/EC approvals and adherence to regulatory, ethical and national standards\n\nExclusion Criteria:\n\n1. Prolonged cardiac arrest with loss of consciousness associated with neurological deficit.\n2. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention\n3. Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH\n4. Recent stroke (\\<14 days)\n5. Recent cranial or spinal surgery (\\<14 days)\n6. Life-threatening active bleeding or hemorrhage into a critical area\n7. Known intracranial tumor\n8. End-stage medical condition with life expectancy \\<3 months (irrespective of the severity of acute PE), as determined by the Investigator\n9. Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\n10. Inability to anticoagulate the patient, or known to have heparin-induced thrombocytopenia (HIT)\n11. Current participation in another drug or device study that may interfere with the conduct of this trial\n12. Ventricular arrhythmias refractory to treatment at the time of enrollment\n13. Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (e.g., compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments), including a contraindication to use of FlowTriever System per local approved labeling\n14. Subject is part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions\n15. Subject was previously enrolled in this study\n16. Subject has received prior thrombolytic (systemic or catheter-directed) therapy for any reason or thrombectomy (surgical or catheter-based) therapy for index PE, within 30 days prior to randomization","locations":[{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Regional Medical Center","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarasota Memorial Hospital","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Mississippi Medical Center","city":"Jackson","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Robert Wood Johnson Medical School","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health","city":"Bay Shore","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY, The University at Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summa Akron","city":"Akron","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPHS Penn Health System","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny General Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Tristar/Centennial","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Medical City Heart & Spine","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Methodist Health San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Besançon University Hospital","city":"Besançon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Grenoble Alpes","city":"La Tronche","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Arnaud de Villeneuve, Montpellier","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Nîmes Caremeau","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Européen Georges-Pompidou, Paris","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse - Hôpital de Rangueil","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein, Campus Kiel","city":"Kiel","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité Campus Virchow Clinic","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Chemnitz","city":"Chemnitz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Carl Gustav Carus an der TU Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Mainz","city":"Mainz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Munich LMU","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Regensburg","city":"Regensburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron, Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz Madrid","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Zurich - Unispital","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Free Hospital London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tine Devolder","phone":"+32 476 53 88 05","email":"tine.devolder@stryker.com"},{"name":"Jen Foss","phone":"978-587-6598","email":"jenifer.foss@stryker.com"}],"primaryOutcomes":["Composite clinical endpoint of the following adjudicated events:"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","orlando-florida","sarasota-florida","atlanta-georgia","jackson-mississippi","new-brunswick-new-jersey","bay-shore-new-york","buffalo-new-york","akron-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","nashville-tennessee","dallas-texas","san-antonio-texas","besan-on-france","la-tronche-france","montpellier-france","n-mes-france","paris-france","toulouse-france","kiel-germany","berlin-germany","chemnitz-germany","dresden-germany","mainz-germany","m-nchen-germany","regensburg-germany","barcelona-spain","madrid-spain","zurich-switzerland","basel-switzerland","london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: FlowTriever System for Pulmonary Embolism","inPlainEnglish":"Randomly assigned Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs.","whoItsFor":["Ages 18 Years to any","Age at enrollment ≥18 years","Objective evidence of a proximal filling defect in at least one main or lobar pulmonary artery","High-risk class of acute PE","RV dysfunction, as defined RV/LV ratio ≥1.0"],"whoShouldSkip":["Prolonged cardiac arrest with loss of consciousness associated with neurological deficit","Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the patient is not appropriate for catheter-based intervention","Known pre-existing CTEPH, or CT signs of chronic PE that may point to pre-existing CTEPH","Recent stroke (\\<14 days)","Recent cranial or spinal surgery (\\<14 days)","Life-threatening active bleeding or hemorrhage into a critical area","Known intracranial tumor"],"whatHappens":"If you join, the listed intervention(s) are FlowTriever System, or Standard of Care. The registry lists allocation as randomized. Randomly assigned Controlled Trial of High-Risk Pulmonary Embolism Comparing FlowTriever System vs.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 34 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.707Z"},{"nctId":"NCT06589804","title":"Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment","officialTitle":"Randomized Phase III Trial of Pembrolizumab vs. Pembrolizumab/Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma With Platinum Refractory Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving cetuximab and pembrolizumab together may be more effective at treating patients with recurrent and/or metastatic HNSCC than pembrolizumab alone.","conditions":["Metastatic Head and Neck Squamous Cell Carcinoma","Metastatic Hypopharyngeal Squamous Cell Carcinoma","Metastatic Laryngeal Squamous Cell Carcinoma","Metastatic Oral Cavity Squamous Cell Carcinoma","Metastatic Oropharyngeal Squamous Cell Carcinoma","Recurrent Head and Neck Squamous Cell Carcinoma","Recurrent Hypopharyngeal Squamous Cell Carcinoma","Recurrent Laryngeal Squamous Cell Carcinoma","Recurrent Neck Squamous Cell Carcinoma of Unknown Primary","Recurrent Oral Cavity Squamous Cell Carcinoma","Recurrent Oropharyngeal Squamous Cell Carcinoma","Refractory Head and Neck Squamous Cell Carcinoma","Refractory Hypopharyngeal Squamous Cell Carcinoma","Refractory Laryngeal Squamous Cell Carcinoma","Refractory Oral Cavity Squamous Cell Carcinoma","Refractory Oropharyngeal Squamous Cell Carcinoma","Stage IV Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8","Stage IV Hypopharyngeal Carcinoma AJCC v8","Stage IV Laryngeal Cancer AJCC v8","Stage IV Lip and Oral Cavity Cancer AJCC v8","Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"BIOLOGICAL","name":"Cetuximab"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"}],"enrollment":158,"startDate":"2025-03-27","completionDate":"2032-12-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC).\n* Previously untreated for recurrent and/or metastatic disease incurable by local therapies.\n* Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx.\n\n  * Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair.\n* Measurable disease.\n* Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy.\n* Patient must have a combined positive score PD-L1 positive (CPS \\>/= 1) tumor.\n* Any radiation therapy must be completed \\>= 10 days prior to registration.\n* Patients should not have received any prior treatment in the recurrent or metastatic setting.\n* Prior therapy with neoadjuvant or induction anti PD-1/PD-L1 monoclonal antibody or cetuximab in the curative setting is allowed if last treatment dose was \\>= 26 weeks prior to registration without evidence of disease progression during that treatment period.\n* Patient has not received a live vaccine within 30 days prior to registration.\n* Patient does not have a history of any contraindication or has a severe hypersensitivity to any component of pembrolizumab or cetuximab (≥ grade 3).\n* Patient has not received chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration.\n* Patient with oropharyngeal cancer only must have negative results from testing of human papillomavirus (HPV) status defined as p16 immunohistochemistry (IHC) and/or HPV in situ hybridization (ISH).\n\n  * Note: A Clinical Laboratory Improvement Act (CLIA) certified circulating tumor HPV deoxyribonucleic acid (ctHPVDNA) assay can be used if tissue sample is not available.\n* Age ≥ 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n* Absolute neutrophil count (ANC) ≥ 1,500/mm\\^3.\n* Platelet count ≥ 100,000/mm\\^3.\n* Hemoglobin (Hgb) ≥ 9 g/dL (if \\< 9 g/dL, then transfusions are acceptable to increase hemoglobin above 9 g/dL).\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula for participant with creatinine levels \\> 1.5 x institutional ULN.\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin \\< ULN for participant with total bilirubin \\> 1.5 x institutional ULN.\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x ULN unless liver metastases are present in which case \\< 5.0 x ULN.\n* Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic, and teratogenic effects.\n\n  * Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 7 days prior to registration is required.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.\n* For treated/stable brain metastases: Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression.\n\n  * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n* Patients does not have a history of active myocarditis.\n* Patients does not have a history of any form of pneumonitis or diffuse idiopathic or immune mediated interstitial pulmonary disease.\n* Patient does not have a history of solid organ transplantation.","locations":[{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fremont - Rideout Cancer Center","city":"Marysville","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"VA Palo Alto Health Care System","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Memorial Hospital Central","city":"Colorado Springs","state":"Colorado","country":"United 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Murtha Regional Cancer Center","city":"Johnstown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion","city":"Mechanicsburg","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center - Monroeville","city":"Monroeville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jefferson Torresdale Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Saint Margaret","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Passavant Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Saint Clair Hospital Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Cancer Center at UPMC Northwest","city":"Seneca","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Cancer Center-Uniontown","city":"Uniontown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Cancer Center-Washington","city":"Washington","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute - Mitchell","city":"Mitchell","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute at Pierre","city":"Pierre","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Cancer Center Oncology Clinic","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford USD Medical Center - Sioux Falls","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute at Yankton","city":"Yankton","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth Cancer Center - North","city":"Saint Johnsbury","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Cancer Center at Stony Point","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vandalia Health/CAMC Institute for Academic Medicine","city":"Charleston","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Southern Lakes VLCC","city":"Burlington","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Saint Luke's South Shore","city":"Cudahy","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-EC Cancer Center","city":"Eau Claire","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Health Care Germantown Health Center","city":"Germantown","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Grafton","city":"Grafton","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora BayCare Medical Center","city":"Green Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Kenosha South","city":"Kenosha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gundersen Lutheran Medical Center","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Bay Area Medical Group-Marinette","city":"Marinette","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Marshfield","city":"Marshfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Milwaukee","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Saint Luke's Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Sinai Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth D N Greenwald Center","city":"Mukwonago","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Oconomowoc Memorial Hospital","city":"Oconomowoc","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic - Oshkosh","city":"Oshkosh","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Racine","city":"Racine","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-Rice Lake","city":"Rice Lake","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic-Sheboygan","city":"Sheboygan","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center-River Region at Stevens Point","city":"Stevens Point","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Medical Center in Summit","city":"Summit","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vince Lombardi Cancer Clinic-Two Rivers","city":"Two Rivers","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Waukesha Memorial Hospital","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UW Cancer Center at ProHealth Care","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Cancer Care-Milwaukee West","city":"Wauwatosa","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora West Allis Medical Center","city":"West Allis","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Overall survival (OS)"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["little-rock-arkansas","marysville-california","palo-alto-california","colorado-springs-colorado","fort-collins-colorado","golden-colorado","greeley-colorado","loveland-colorado","aventura-florida","miami-beach-florida","boise-idaho","caldwell-idaho","coeur-dalene-idaho","nampa-idaho","post-falls-idaho","sandpoint-idaho","barrington-illinois","chicago-illinois","crystal-lake-illinois","danville-illinois","decatur-illinois","downers-grove-illinois","effingham-illinois","elgin-illinois","hazel-crest-illinois","libertyville-illinois","macomb-illinois","mattoon-illinois","new-lenox-illinois","normal-illinois","ofallon-illinois","oak-lawn-illinois","orland-park-illinois","palos-heights-illinois","park-ridge-illinois","peoria-illinois","rockford-illinois","shiloh-illinois","springfield-illinois","urbana-illinois","crown-point-indiana","ames-iowa","boone-iowa","cedar-rapids-iowa","fort-dodge-iowa","jefferson-iowa","marshalltown-iowa","hays-kansas","kansas-city-kansas","lawrence-kansas","olathe-kansas","overland-park-kansas","salina-kansas","topeka-kansas","westwood-kansas","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","brighton-michigan","canton-michigan","chelsea-michigan","flint-michigan","lansing-michigan","livonia-michigan","pontiac-michigan","ypsilanti-michigan","bemidji-minnesota","burnsville-minnesota","coon-rapids-minnesota","edina-minnesota","maplewood-minnesota","minneapolis-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","cape-girardeau-missouri","city-of-saint-peters-missouri","creve-coeur-missouri","kansas-city-missouri","lees-summit-missouri","liberty-missouri","osage-beach-missouri","st-louis-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","kalispell-montana","missoula-montana","lebanon-new-hampshire","basking-ridge-new-jersey","cherry-hill-new-jersey","middletown-new-jersey","montvale-new-jersey","sewell-new-jersey","commack-new-york","glens-falls-new-york","harrison-new-york","new-york-new-york","syracuse-new-york","uniondale-new-york","verona-new-york","chapel-hill-north-carolina","hendersonville-north-carolina","pinehurst-north-carolina","bismarck-north-dakota","fargo-north-dakota","centerville-ohio","dayton-ohio","franklin-ohio","greenville-ohio","sylvania-ohio","troy-ohio","lawton-oklahoma","oklahoma-city-oklahoma","ontario-oregon","oregon-city-oregon","portland-oregon","allentown-pennsylvania","bethlehem-pennsylvania","carlisle-pennsylvania","east-stroudsburg-pennsylvania","erie-pennsylvania","greensburg-pennsylvania","harrisburg-pennsylvania","indiana-pennsylvania","johnstown-pennsylvania","mechanicsburg-pennsylvania","monroeville-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","seneca-pennsylvania","uniontown-pennsylvania","washington-pennsylvania","charleston-south-carolina","mitchell-south-dakota","pierre-south-dakota","sioux-falls-south-dakota","yankton-south-dakota","saint-johnsbury-vermont","richmond-virginia","charleston-west-virginia","burlington-wisconsin","cudahy-wisconsin","eau-claire-wisconsin","germantown-wisconsin","grafton-wisconsin","green-bay-wisconsin","kenosha-wisconsin","la-crosse-wisconsin","marinette-wisconsin","marshfield-wisconsin","milwaukee-wisconsin","mukwonago-wisconsin","oconomowoc-wisconsin","oshkosh-wisconsin","racine-wisconsin","rice-lake-wisconsin","sheboygan-wisconsin","stevens-point-wisconsin","summit-wisconsin","two-rivers-wisconsin","waukesha-wisconsin","wauwatosa-wisconsin","west-allis-wisconsin","weston-wisconsin"],"enrichment":{"headline":"Phase 3: testing Cetuximab for Metastatic Head and Neck Squamous Cell Carcinoma","inPlainEnglish":"This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic). Cetuximab is in a class of medications called monoclonal antibodies.","whoItsFor":["Ages 18 Years to any","Histologically confirmed diagnosis head and neck squamous cell carcinomas (HNSCC)","Previously untreated for recurrent and/or metastatic disease incurable by local therapies","Primary tumor location of oral cavity, oropharynx, larynx, or hypopharynx","Note: Other primary tumor sites of HNSCC, including nasopharynx primary tumor are not eligible. Unknown primary tumors may be eligible and can be enrolled at the discretion of the treatment team with approval by the study chair","Measurable disease","Must have platinum-refractory disease defined as disease progression during or ≤ 29 weeks after completion of definitive therapy (chemoradiation therapy) or adjuvant (post-operative) therapy","Patient must have a combined positive score PD-L1 positive (CPS \\>/= 1) tumor"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cetuximab, or Computed Tomography. The registry lists allocation as randomized. This phase III trial compares the effect of adding cetuximab to pembrolizumab versus pembrolizumab alone in treating patients with head and neck squamous cell carcinoma (HNSCC) that has come back after a period of improvement (recurrent) and/or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 158 people at 202 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.019Z"},{"nctId":"NCT06592820","title":"Endoscopic Ultrasound Shear Wave Elastography Study","officialTitle":"Endoscopic Ultrasound With Shear Wave Elastography for the Assessment of Liver Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Olympus Corporation of the Americas","sponsorClass":"INDUSTRY","summary":"This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled. EUS Shear Wave Elastography and Attenuation Imaging technologies will be compared to liver biopsy and FibroScan results and other non-invasive fibrosis screening modalities . The data collected during this study will be evaluated in accordance with the procedures set forth in the protocol. The main question\\[s\\] it aims to answer are:\n\n* Establish optimal cutoffs for EUS-SWE in reference to liver biopsies staging system for liver fibrosis\n* Evaluate the diagnostic performance of EUS-SWE compared to FibroScan (VCTE) and to other non-invasive fibrosis screening modalities (screening scores).\n\nParticipants will undergo:\n\n* Endoscopic Ultrasound with Shear Wave Elastography (SWE) and Attenuation Imaging (ATI)\n* Liver biopsy\n* FibroScan","conditions":["MASLD","MASH","Fibrosis, Liver","Chronic Liver Disease"],"keywords":["Shear Wave Elastography","Shear Wave","FibroScan","Attenuation Imaging"],"interventions":[{"type":"DEVICE","name":"Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging"},{"type":"DEVICE","name":"FibroScan"},{"type":"DEVICE","name":"Liver biopsy"}],"enrollment":300,"startDate":"2025-09-03","completionDate":"2028-11-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 18 years of age or older\n2. Willing and able to provide informed consent\n3. Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \\>10% total body weight\n4. Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \\>10% total body weight\n5. BMI \\>/=28\n6. Clinical suspicion of MASLD (hepatic steatosis with at least one of five cardiometabolic risk factors: 1) overweight or obesity, 2) elevated glucose, 3) low HDL-C, 4) hypertension, and/or 5) hypertriglyceridemia) or MASH (additionally characterized by the presence of inflammation and hepatocellular ballooning) with or without fibrosis, as determined by non-invasive or minimally invasive techniques (e.g. abdominal ultrasound, FibroScan)\n\nExclusion Criteria:\n\n1. Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma\n2. Prior history of Hepatitis B or C infection\n3. Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)\n4. Histological evidence of other concomitant chronic liver disease on biopsy\n5. Inadequate liver biopsy\n6. Prior history of or current excess alcohol consumption (\\>140 g/week and \\>210 g/week for females and males, respectively) documented in EMR","locations":[{"facility":"Hoag Memorial Hospital","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Geisinger Medical Center","city":"Danville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Heather Golden, MSc, CCRP","phone":"734-740-4642","email":"Heather.Golden@olympus.com"},{"name":"Kayla Myers","phone":"484-896-5000","email":"Kayla.Myers@olympus.com"}],"primaryOutcomes":["Shear Wave Elastography (SWE) vs liver biopsy METAVIR staging system"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["newport-beach-california","boston-massachusetts","danville-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging for MASLD","inPlainEnglish":"This study shall be a prospective, multicenter, single arm, consecutive, treatment study conducted in a post-market setting using commercially available devices. Consecutive, eligible patients with clinical suspicion of MASLD or MASH reporting for an endoscopic ultrasound and liver biopsy for evaluation of fibrosis will be enrolled.","whoItsFor":["Ages 18 Years to any","18 years of age or older","Patient scheduled to undergo EUS with liver biopsy, either same session or separately; if separate, liver biopsy should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \\>10% total body weight","Patient scheduled to undergo or have undergone FibroScan, which should be performed within 3 months of the EUS (either before or after) with no interval bariatric procedure/surgery or weight change of \\>10% total body weight"],"whoShouldSkip":["Patients with surgically altered anatomy that precludes adequate endosonographic visualization of the liver parenchyma","Prior history of Hepatitis B or C infection","Decompensated cirrhosis (GI bleeding, ascites, encephalopathy)","Histological evidence of other concomitant chronic liver disease on biopsy","Inadequate liver biopsy","Prior history of or current excess alcohol consumption (\\>140 g/week and \\>210 g/week for females and males, respectively) documented in EMR"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.439Z"},{"nctId":"NCT06592833","title":"Psilocybin With Pimavanserin Compared to Psilocybin Alone for the Treatment of Major Depressive Disorder","officialTitle":"Investigating the Role of Serotonin in the Mechanism of Action of Psilocybin in Patients With Major Depressive Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"This is an interventional, parallel arm assignment treatment study in individuals with Major Depressive Disorder (MDD). Each individual will be treated with a single dose of pimavanserin or placebo plus a single dose of psilocybin. Evaluations will be taken before dosing and following dosing at several timepoints up to 5 weeks post-dosing.","conditions":["Major Depressive Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Pimavanserin"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2025-02-25","completionDate":"2029-03","sex":"ALL","minAge":"21 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 21-80 years, any gender\n* Current primary diagnosis of Unipolar Major Depressive Disorder (MDD) without psychotic features using DSM-5 criteria\n* 24-item Hamilton Rating Scale for Depression (HRSD) ≥16\n* Current diagnosis of Major Depressive Episode (MDE)\n* Capable of providing informed consent and complying with study procedures\n* Currently using or agreeing to use a highly effective contraception, if person of childbearing potential (such as condoms, IUD, or oral contraceptive), for duration of the study. Male participants agree to use highly effective contraception with partners of childbearing potential\n* Discontinuation of any serotonergic drug for at least 2 weeks or 5 half-lives (whichever of the two is longer) prior to psilocybin exposure\n\nExclusion Criteria:\n\n* Any severity of substance use disorder in the last 6 months (excluding tobacco use disorder) as determined by DSM-V criteria via the SCID\n* Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months\n* Use of psychedelics in the last 12 months\n* Non-medical or illicit use of ketamine in the past 12 months\n* Negative reaction after prior use of psychedelics\n* Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder\n* Severe depression as indicated by Clinical Global Impressions (CGI)-Severity score ≥ 5 at baseline\n* Significant suicidal ideation as indicated by C-SSRS \\> 2 in the past 6 months at time of screening\n* Suicide attempt in the past 2 years, or clinician concern that the patient poses a risk to self or others\n* Acute, severe, or unstable medical illness\n* Weight \\> 300 lbs., or girth size incompatible with scanner bore\n* Any conditions/qualities that make participation in MRI imaging unsafe\\*\n* Any physical or intellectual disability adversely affecting ability to complete assessments.\n* Current pregnancy or currently breast feeding.\n* Any clinically significant abnormal lab test result, including clinically significant abnormal baseline liver and/or renal function tests\n* Currently being treated with a contraindicated medication. Contraindicated medications include antipsychotic medications, serotonergic antidepressant medications, and mood stabilizers that may attenuate the effects of psilocybin. Strong CYP3A4 inhibitors and inducers are also contraindicated. UGT1A9 and UGT1A10 inhibitors, monoamine oxidase, and aldehyde or alcohol dehydrogenase inhibitors are prohibited concomitant medications.\n* History of abnormal QT prolongation or QTc interval \\>450 ms on screening\n* Use of medications known to prolong the QT interval\n* Any congenital prolongation of the QT interval or a family history of long QT syndrome\n* A family history of sudden cardiac or unexplained death\n* A family history in a first-degree relative of psychosis/schizophrenia or related disorders\n* A first-degree family history of bipolar disorder\n* A history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication\n* A history of any cardiovascular disorder/condition known to increase the possibility of QT prolongation, or any other risk factors for prolonged QT interval/torsades de pointes (including symptomatic bradycardia, hypokalemia, hypomagnesemia, hypocalcemia, heart failure, or Brugada Syndrome)\n* Preexisting cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension, hypertension, tachycardia, and any cardiovascular conditions that may be worsened/exacerbated by elevated blood pressure or heart rate.\n* Baseline vital sign parameters at screening and on day of dosing prior to dose that exceed to the following values for systolic blood pressure (SBP), diastolic (DBP), and heart rate (HR): SBP \\> 139 mmHg, DBP 89 mmHg, and HR \\> 90 bpm\n* Hypersensitivity to either psilocybin or pimavanserin\n* Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin\n* Positive urine toxicology at screening\n* Any clinically significant abnormalities on 12-lead electrocardiogram (ECG)\n* Mini-Mental State Examination (MMSE) score \\< 25\n* Brief Psychiatric Rating Scale (BPRS-6) \\> 5\n* Potential fall risk","locations":[{"facility":"Icahn School of Medicine at Mount Sinai, Center for Psychedelic Therapy Research","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Depression and Anxiety Center Icahn School of Medicine at Mount Sinai","phone":"(212) 241-6539","email":"dac@mssm.edu"}],"primaryOutcomes":["Mystical Experience Questionnaire (MEQ-30) Score"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Psilocybin for Major Depressive Disorder","inPlainEnglish":"This is an treatment, parallel arm assignment treatment study in individuals with Major Depressive Disorder (major depression). Each individual will be treated with a single dose of pimavanserin or dummy treatment (placebo) plus a single dose of psilocybin.","whoItsFor":["Ages 21 Years to 80 Years","Age 21-80 years, any gender","Current primary diagnosis of Unipolar Major Depressive Disorder (major depression) without psychotic features using DSM-5 criteria","24-item Hamilton Rating Scale for Depression (HRSD) ≥16","Current diagnosis of Major Depressive Episode (MDE)","Discontinuation of any serotonergic drug for at least 2 weeks or 5 half-lives (whichever of the two is longer) prior to psilocybin exposure"],"whoShouldSkip":["Any severity of substance use disorder in the last 6 months (excluding tobacco use disorder) as determined by DSM-V criteria via the SCID","Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months","Use of psychedelics in the last 12 months","Non-medical or illicit use of ketamine in the past 12 months","Negative reaction after prior use of psychedelics","Past or current psychotic disorder (including psychotic major depression), mania, or bipolar disorder","Severe depression as indicated by Clinical Global Impressions (CGI)-Severity score ≥ 5 at baseline"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, Pimavanserin, or Placebo. The registry lists allocation as randomized. This is an treatment, parallel arm assignment treatment study in individuals with Major Depressive Disorder (major depression).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.108Z"},{"nctId":"NCT06593314","title":"Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes","officialTitle":"Identifying Undiagnosed HFpEF Among Patients With Type 2 Diabetes Using Ultromics AI HFpEF Algorithm","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Texas Southwestern Medical Center","sponsorClass":"OTHER","summary":"A pragmatic electronic health record (EHR) based randomized controlled trial to evaluate the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.","conditions":["Heart Failure","Diabetes"],"keywords":["Subclinical Heart Failure; Electronic Alerts; Diabetes"],"interventions":[{"type":"BEHAVIORAL","name":"Message with EchoGo"},{"type":"BEHAVIORAL","name":"Standard Message"}],"enrollment":800,"startDate":"2025-08-06","completionDate":"2027-05-15","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Clinical cohort inclusion exclusion criteria:\n\nInclusion Criteria:\n\n* Patients with diagnosis of Type 2 diabetes and High WATCH DM score.\n* Echocardiogram available in last 6-months.\n\nExclusion Criteria:\n\n* History of HF\n* Not eligible for prescription of new GLP-1RA or SGLT2i or ns-MRA\n\nCorresponding providers to patients identified by the above inclusion exclusion criteria will be included in the clinical trial of the decision support tool.","locations":[{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ambarish Pandey, MD","phone":"617-869-8957","email":"Ambarish.Pandey@UTSouthwestern.edu"}],"primaryOutcomes":["Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 3 months follow-up","Frequency of prescription of SGLT-2i medication at outpatient clinic visits over 6 months follow-up"],"hasResults":false,"conditionSlugs":["type-2-diabetes","heart-failure"],"drugSlugs":[],"locationSlugs":["dallas-texas"],"enrichment":{"headline":"Not a traditional drug phase: Message with EchoGo for Heart Failure","inPlainEnglish":"A pragmatic electronic health record (EHR) based randomly assigned controlled trial to measure the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.","whoItsFor":["Clinical cohort inclusion"],"whoShouldSkip":["who can join:","Patients with diagnosis of Type 2 diabetes and High WATCH DM score","Echocardiogram available in last 6-months"],"whatHappens":"If you join, the listed intervention(s) are Message with EchoGo, or Standard Message. The registry lists allocation as randomized. A pragmatic electronic health record (EHR) based randomly assigned controlled trial to measure the utility of providing Ultromics EchoGo analysis results and recommendations for HF risk prevention therapies using an EHR embedded clinical decision support tool.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 800 people at Dallas. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.443Z"},{"nctId":"NCT06594536","title":"Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity","officialTitle":"Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"ADHD is a neurodevelopmental disorder. It is the most common neurodevelopmental disorder in children and adolescents. Its prevalence is estimated at 5.9% in this population. The symptoms of ADHD combine attention deficit with behavioural disorders such as hyperactivity and impulsivity. Current treatment for ADHD is based on psychotherapeutic and psychoeducational measures aimed at improving behaviour and its impact on the family, social and school environment. Drug treatments may also be used, depending on the impact of the disorder and the effectiveness of alternative treatments. Psychostimulants such as amphetamine derivatives and methylphenidate are around 80% effective.\n\nSulforaphane is an active substance derived from broccoli that has already been tested in the treatment of other neurodevelopmental disorders. The main hypothesis is that sulforaphane is effective in treating the symptoms of Attention Deficit Disorder with or without Hyperactivity (ADHD) in children.","conditions":["Attention Deficit Disorder"],"keywords":["Sulforaphane"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Sulforaphane"},{"type":"OTHER","name":"Placebo"}],"enrollment":70,"startDate":"2024-12-01","completionDate":"2027-08-01","sex":"ALL","minAge":"6 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children aged 6 to 12\n* Diagnosis of ADHD according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)\n* Followed or hospitalised in an investigating centre\n* Consent of holders of parental authority\n* Patient covered by health insurance (social security or CMU)\n* Patients able to swallow capsules\n\nExclusion Criteria:\n\n* Allergy to broccoli\n* Psychotropic treatment including methylphenidate in the month prior to inclusion\n* Ongoing psychotherapeutic and/or psycho-educational treatment specific to ADHD\n* ASD (Autism Spectrum Disorder) according to DSM-5 criteria, intellectual disability (IQ\\< 80)\n* Chronic neurological disease, epilepsy\n* Holders of parental authority under guardianship or curatorship\n* Previous intake of sulforaphane\n* Known hypothyroidism or current thyroid treatment\n* Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, where applicable\n* Patient under AME (state medical aid)","locations":[{"facility":"Robert Debre Hospital","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric ACQUAVIVA, PhD","phone":"0140034092","email":"eric.acquaviva@aphp.fr"}],"primaryOutcomes":["Inattention scores in ADHD-RS parents","Hyperactivity/impulsivity scores in ADHD-RS parents"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: Sulforaphane for Attention Deficit Disorder","inPlainEnglish":"It is the most common neurodevelopmental disorder in children and adolescents. Its prevalence is estimated at 5.9% in this population.","whoItsFor":["Ages 6 Years to 12 Years","Children aged 6 to 12","Diagnosis of ADHD according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)","Followed or hospitalised in an investigating centre","Consent of holders of parental authority","Patient covered by health insurance (social security or CMU)","Patients able to swallow capsules"],"whoShouldSkip":["Allergy to broccoli","Psychotropic treatment including methylphenidate in the month prior to inclusion","Ongoing psychotherapeutic and/or psycho-educational treatment specific to ADHD","ASD (Autism Spectrum Disorder) according to DSM-5 criteria, intellectual disability (IQ\\< 80)","Chronic neurological disease, epilepsy","Holders of parental authority under guardianship or curatorship","Previous intake of sulforaphane"],"whatHappens":"If you join, the listed intervention(s) are Sulforaphane, or Placebo. The registry lists allocation as randomized. It is the most common neurodevelopmental disorder in children and adolescents.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 70 people at Paris. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.640Z"},{"nctId":"NCT06597695","title":"A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression","officialTitle":"A Ketamine-assisted Group Therapy Intervention for Spanish-speaking Adults With Depression","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Juliana Zambrano, MD, MPH","sponsorClass":"OTHER","summary":"This is a pilot clinical trial to assess the feasibility, safety, and preliminary efficacy of ketamine-assisted group therapy for Spanish-speaking adults with depression","conditions":["Depression"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ketamine-assisted psychotherapy"}],"enrollment":10,"startDate":"2025-07-23","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\. Self-identifying Latinx, Spanish-speaking 2. Adults 18-64 years 3. Meet DSM-5 criteria for major depressive disorder as evaluated by study clinician 4. Montgomery-Asberg depression scale (MADRS) score of 20 or above at baseline 4. Participants must have an MGB psychiatrist and primary care provider.\n\nExclusion Criteria:\n\n1. History of primary psychotic disorder, by history\n2. History Bipolar I disorder, by history\n3. Unstable complex PTSD, as assessed by study clinician\n4. History of dissociative identity disorder\n5. History of neurocognitive disorder\n6. History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview\n7. Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \\<140/90 mmHg.\n8. History of aortic dissection\n9. History of myocardial infarction\n10. History of aneurysm\n11. History of hepatic impairment.\n12. History of epilepsy\n13. History of prior hypersensitivity to ketamine\n14. Body Mass Index greater than 35\n15. Body Mass Index less than 18.5\n16. Are pregnant, breastfeeding, or planning to become pregnant within 12 weeks of treatment completion\n17. Enrolled in other clinical trial for the treatment of depression or other behavioral health diagnosis\n18. Inability to provide consent.","locations":[{"facility":"Massachusetts General Hospital, Chelsea","city":"Chelsea","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juliana Zambrano, MD","phone":"617-726-2000","email":"JZAMBRANO2@mgh.harvard.edu"}],"primaryOutcomes":["Evaluate feasibility of a culturally adapted group-based ketamine intervention for Spanish- speaking adults with depression in a community setting","To assess the safety of a ketamine-assisted group psychotherapy intervention for Spanish-speaking participants with depression in a community setting."],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["chelsea-massachusetts"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Ketamine-assisted psychotherapy for Depression","inPlainEnglish":"This is a pilot clinical trial to assess the feasibility, safety, and preliminary how well it works of ketamine-assisted group therapy for Spanish-speaking adults with depression","whoItsFor":["Ages 18 Years to 64 Years"],"whoShouldSkip":["History of primary psychotic disorder, by history","History Bipolar I disorder, by history","Unstable complex PTSD, as assessed by study clinician","History of dissociative identity disorder","History of neurocognitive disorder","History of severe and/or recent substance use disorder, by history and as assessed by study clinician after clinical evaluation and interview","Uncontrolled hypertension, tachycardia, or unstable cardiopulmonary disease, by history a. Blood pressure on initial screen must be \\<140/90 mmHg"],"whatHappens":"If you join, the listed intervention(s) are Ketamine-assisted psychotherapy. The registry lists allocation as na. This is a pilot clinical trial to assess the feasibility, safety, and preliminary how well it works of ketamine-assisted group therapy for Spanish-speaking adults with depression","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 10 people at Chelsea. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.790Z"},{"nctId":"NCT06599658","title":"COVID-19 Booster and IIV Schedule in Immunocompromised Hosts","officialTitle":"The Immunogenicity and Safety of COVID-19 and Influenza Vaccine Co-administration and Interval in Immunocompromised Hosts","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"NONE","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","sponsorClass":"OTHER","summary":"The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomized controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).\n\nThe main questions it aims to answer are:\n\n1. Is co-administration of seasonal inactivated influenza vaccine (IIV) with the most up-to-date recommended COVID-19 booster dose non-inferior in inducing a 1-month peak protective humoral response against COVID-19, compared to a strategy of sequential administration of COVID-19 booster dose followed by seasonal IIV given one month later?\n2. Is the administration of the most up-to-date recommended COVID-19 booster doses at 3-month intervals superior at maintaining a longer term protective humoral immune response, compared to booster doses administered at 6-month intervals?\n\nResearchers will compare (1) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 3-month interval, (2) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 3-month interval, (3) COVID-19 and Influenza vaccines administered at Day 0 + COVID-19 Booster at a 6-month interval, and (4) COVID-19 vaccine administered at Day 0 and Influenza vaccine administered at Day 28 + COVID-19 Booster at a 6-month interval to see if median neutralization capacity of patient sera is non-inferior in the co- vs. sequential administration arms at 1-month after the initial COVID-19 booster and superior in the 3-month interval arms vs. the 6-month interval arms at 12 months after the initial COVID-19 booster. These outcomes will also be compared at 2-months for question 1 and 6-months for question 2.\n\nPeople living with immunocompromising conditions who take part in the trial will have blood samples drawn to verify immune response, be monitored for changes in clinical events and therapies, and complete questionnaires to verify adverse effects, quality of life and economic impact.","conditions":["COVID 19","Influenza","Rheumatoid Arthritis (RA)","Systemic Lupus Erthematosus","Inflammatory Bowel Disease","Solid Organ Transplant Recipients","Immunocompromised Host","People Living With HIV"],"keywords":["Vaccine","Immunogenicity","Safety"],"interventions":[{"type":"BIOLOGICAL","name":"Inactivated influenza vaccine (IIV) at baseline"},{"type":"BIOLOGICAL","name":"COVID-19 Vaccines at a 3-month interval"},{"type":"BIOLOGICAL","name":"Inactivated influenza vaccine at Month 1"},{"type":"BIOLOGICAL","name":"COVID-19 Vaccines at a 6-month interval"}],"enrollment":660,"startDate":"2024-11-20","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- All participants must meet ALL the following inclusion criteria: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:\n\na) Received a solid organ transplant (SOT) ≥3-months ago, and treated with a conventional maintenance immunosuppression regimen; b) People living with HIV (PLWH) receiving ART for ≥6 months who meet at least one of the following conditions: i) AIDS-defining illness in the last 6 months, ii) TB diagnosis in the last 6-months, iii) CD4\\&lt;200 cells/µL in the last 6 months, iv) CD4%\\&lt;15% in the last 6 months, or v) absence of HIV viral suppression in the last 6 months; c) Inflammatory bowel disease (IBD) treated with a conventional or biologic immunosuppressive agent for ≥3 months; d) Rheumatoid arthritis or systemic lupus erythematosus (herein referred to as rheumatological disease (RD)) treated with a conventional or biologic immunosuppressive agent for ≥3 months.\n\nExclusion Criteria:\n\n* Potential participants who meet ANY of the following criteria will be excluded:\n\n  i. Received any of the following:\n  1. Annual vaccination against influenza \\&lt; 6 months ago\n  2. COVID-19 booster \\&lt; 3 months ago ii. History of any of the following:\n\n  <!-- -->\n\n  1. life-threatening reaction any component of the IIV or COVID-19 vaccines\n  2. Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination\n  3. Contraindication to intramuscular vaccines such as bleeding disorder, severe thrombocytopenia, etc; iii. Receiving intravenous immunoglobulins; iv. Have underlying primary inborn errors of immunity; v. Receiving chemotherapy such as cyclophosphamide \\&lt; 6-months ago; vi. Unable to provide informed consent","locations":[{"facility":"Maisonneuve -Rosemont Installation","city":"Montreal","state":"Quebec","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute of McGill University Health Centre","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ruth Sapir-Pichhadze, B.Med.Sc, MD, MSc, PhD, FRCPC","phone":"5149341934","email":"ruth.sapir-pichhadze.med@ssss.gouv.qc.ca"}],"primaryOutcomes":["Median neutralization capacity against prevalent SARS-CoV-2 variant"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis","lupus","hiv"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Phase 2: testing Inactivated influenza vaccine (IIV) at baseline for COVID 19","inPlainEnglish":"The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomly assigned controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC). The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to any","\\- All participants must meet ALL the following who can join: i. Adults (≥18 years) ii. Received the primary mRNA COVID-19 vaccine series (i.e., ≥3 doses) iii. Have at least one of the following immunocompromising conditions:"],"whoShouldSkip":["Potential participants who meet ANY of the following criteria will be excluded:","i. Received any of the following:","Annual vaccination against influenza \\&lt; 6 months ago","COVID-19 booster \\&lt; 3 months ago ii. History of any of the following:","life-threatening reaction any component of the IIV or COVID-19 vaccines","Guillain-Barre syndrome or myocarditis within 6 weeks of a previous influenza or COVID-19 vaccination"],"whatHappens":"If you join, the listed intervention(s) are Inactivated influenza vaccine (IIV) at baseline, COVID-19 Vaccines at a 3-month interval, or Inactivated influenza vaccine at Month 1. The registry lists allocation as randomized. The goal of this pragmatic embedded open-label, 2 x 2 factorial phase II randomly assigned controlled trial is to evaluate strategies to improve COVID-19 booster and influenza vaccine immunogenicity in people living with immunocompromising conditions (PLIC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 660 people at 3 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.961Z"},{"nctId":"NCT06600321","title":"A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma","officialTitle":"A Phase 1 Study of ALN-BCAT as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced or Metastatic Hepatocellular Carcinoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alnylam Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of the dose escalation part of the study is to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as monotherapy and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to evaluate the antitumor activity of ALN-BCAT as monotherapy and in combination with pembrolizumab; to characterize the safety and tolerability of ALN-BCAT as monotherapy and in combination with pembrolizumab.","conditions":["Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma"],"keywords":["Hepatocellular carcinoma (HCC)","Pembrolizumab","CTNNB1","Liver disease","Liver cancer","Liver neoplasms","Carcinoma, hepatocellular","WNT pathway activating"],"interventions":[{"type":"DRUG","name":"ALN-BCAT"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":158,"startDate":"2024-12-30","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria\n* Has had at least one line of systemic therapy for unresectable advanced or metastatic disease\n* Has at least one wingless-related integration site (WNT)-pathway activating mutation\n* Child-Pugh class A or B7\n\nExclusion Criteria:\n\n* Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors\n* Has symptomatic extrahepatic disease\n* Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug\n\nNote: other protocol defined inclusion / exclusion criteria apply","locations":[{"facility":"Clinical Trial Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Rozzano","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Busan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Seongnam","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alnylam Clinical Trial Information Line","phone":"1-877-ALNYLAM","email":"clinicaltrials@alnylam.com"},{"name":"Alnylam Clinical Trial Information Line","phone":"1-877-256-9526","email":"clinicaltrials@alnylam.com"}],"primaryOutcomes":["Frequency of Adverse Events (AEs)","Severity of AEs","Dose Escalation: Occurrence of Dose-limiting Toxicities (DLTs)","Dose Expansion: Antitumor Activity as assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["phoenix-arizona","la-jolla-california","los-angeles-california","jacksonville-florida","atlanta-georgia","chicago-illinois","ann-arbor-michigan","rochester-minnesota","new-york-new-york","cleveland-ohio","pittsburgh-pennsylvania","dallas-texas","houston-texas","san-antonio-texas","richmond-virginia","milan-italy","rozzano-italy","verona-italy","busan-south-korea","seongnam-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing ALN-BCAT for Advanced Hepatocellular Carcinoma","inPlainEnglish":"The purpose of the dose escalation part of the study is to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as this drug alone and in combination with pembrolizumab. The purpose of the dose expansion part of the of the study is to measure the antitumor activity of ALN-BCAT as this drug alone and in combination with pembrolizumab; to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab.","whoItsFor":["Ages 18 Years to any","Has HCC confirmed histologically or cytologically, or, for patients with liver cirrhosis, clinically by the American Association for the Study of Liver Diseases (AASLD) criteria","Has had at least one line of systemic therapy for unresectable advanced or metastatic disease","Has at least one wingless-related integration site (WNT)-pathway activating mutation","Child-Pugh class A or B7"],"whoShouldSkip":["Has fibrolamellar HCC, sarcomatoid HCC, or mixed cholangio-HCC tumors","Has symptomatic extrahepatic disease","Has received anti-cancer therapy or investigational drugs ≤3 weeks prior to the first dose of study drug","Note: other protocol defined inclusion /"],"whatHappens":"If you join, the listed intervention(s) are ALN-BCAT, or Pembrolizumab. The registry lists allocation as randomized. The purpose of the dose escalation part of the study is to characterize the whether it is safe and how hard side effects are to live with of ALN-BCAT as this drug alone and in combination with pembrolizumab; and to determine the recommended dose(s) for expansion (RDFE) of ALN-BCAT as this drug alone and in combination with pembrolizumab.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 158 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.633Z"},{"nctId":"NCT06601296","title":"Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer","officialTitle":"STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Texas Southwestern Medical Center","sponsorClass":"OTHER","summary":"To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).","conditions":["Metastatic Renal Cell Carcinoma ( mRCC)","OligoProgressive Metastatic Disease"],"keywords":["renal","kidney","mrcc","metastatic","cancer","STING","PULSAR","SABr","SPARK","nivolumab","IMSA 101"],"interventions":[{"type":"DRUG","name":"IMSA101"}],"enrollment":15,"startDate":"2025-04-01","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have metastatic ccRCC.\n* Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection.\n* Karnofsky Performance Status (KPS) of at least 50%.\n* Life expectancy of at least 6 months.\n* Age ≥ 18 years.\n* Patients must have adequate organ and marrow function within 14 days prior to study entry.\n* All IMDC risk categories are allowed.\n\nExclusion Criteria:\n\n* Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors.\n* Prior STING agonist use.\n* Any condition requiring systemic treatment with corticosteroids (\\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n* Uncontrolled adrenal insufficiency.","locations":[{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA","phone":"214 648 1836","email":"Sarah.Hardee@UTSouthwestern.edu"},{"name":"RAQUIBUL HANNAN, MD, PhD.","phone":"214 645 7696","email":"Raquibul.Hannan@UTSouthwestern.edu"}],"primaryOutcomes":["To evaluate the PFS rate associated with the therapeutic intervention. PFS is defined as the duration of time from initiation of PULSAR/IMSA101 to disease progression as defined by RECIST1.1 or death."],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["dallas-texas"],"enrichment":{"headline":"Phase 2: testing IMSA101 for Metastatic Renal Cell Carcinoma ( mRCC)","inPlainEnglish":"To measure the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).","whoItsFor":["Ages 18 Years to any","Patients must have metastatic ccRCC","Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection","Karnofsky Performance Status (KPS) of at least 50%","Life expectancy of at least 6 months","Patients must have adequate organ and marrow function within 14 days prior to study entry","All IMDC risk categories are allowed"],"whoShouldSkip":["Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors","Prior STING agonist use","Uncontrolled adrenal insufficiency"],"whatHappens":"If you join, the listed intervention(s) are IMSA101. The registry lists allocation as na. To measure the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 15 people at Dallas. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.941Z"},{"nctId":"NCT06606808","title":"Fluorescence Imaging of Risankizumab-800CW in Inflammatory Bowel Disease","officialTitle":"Investigating the Safety, Feasibility, and Optimal Dose of Risankizumab-800CW for Visualizing Drug Targeting in Inflammatory Bowel Disease","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"University Medical Center Groningen","sponsorClass":"OTHER","summary":"Crohn\\&#39;s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor. Primary non-response to risankizumab is high in both CD and UC. Currently, there are no predictors of response to risankizumab and the actual mechanism of action has not yet been elucidated. To gain better understanding of the drug targeting of risankizumab in IBD, the University Medical Center Groningen (UMCG) developed fluorescently labeled risankizumab (risankizumab-800CW). This study aims to assess the safety and the optimal dose of risankizumab-800CW to visualize and potentially quantify the local drug concentration and predict treatment response in IBD patients using in vivo and ex vivo fluorescence molecular imaging (FMI).","conditions":["Ulcerative Colitis (UC)","Crohn Disease (CD)"],"keywords":["Fluorescence Molecular Endoscopy","Inflammatory Bowel Disease","Risankizumab-800CW"],"interventions":[{"type":"DRUG","name":"Risankizumab-800CW 4.5 mg"},{"type":"DRUG","name":"Risankizumab-800CW 15 mg"},{"type":"DRUG","name":"Risankizumab-800CW 25 mg"},{"type":"DRUG","name":"Risankizumab-800CW optimal dose"}],"enrollment":18,"startDate":"2024-11-08","completionDate":"2025-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for part A:\n\n* Established IBD diagnosis\n* Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \\&gt; 60 μg/g\n* Patients must be eligible for risankizumab therapy\n* Minimum age of 18 years\n* Written informed consent\n* Clinical indication for an endoscopic procedure\n\nInclusion Criteria for part B:\n\n* Established IBD diagnosis\n* Patients must be on risankizumab therapy for at least 14 weeks\n* Minimum age of 18 years\n* Written informed consent\n* Clinical indication for an endoscopic procedure\n\nExclusion Criteria for part A:\n\n* A female study patient who is pregnant or provides breastfeeding\n* A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent\n* Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an exclusion criteria)\n* Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)\n\nExclusion Criteria for part B:\n\n* A female study patient who is pregnant or provides breastfeeding\n* A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks\n* Medical or psychiatric conditions that compromise the patient's ability to give informed consent\n* Active extra gastrointestinal manifestations of Crohn's disease (e.g. uveitis or pyoderma gangrenosum at vital locations)","locations":[{"facility":"University Medical Center Groningen","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wouter B Nagengast, MD, PharmD, PhD","phone":"+31(0)503612620","email":"w.b.nagengast@umcg.nl"}],"primaryOutcomes":["Determine the safety of risankizumab-800CW in IBD","Blood pressure","Heart rate","Temperature","Investigate the feasibility of using ex vivo FMI to detect risankizumab-800CW","Investigate the feasibility of using FME to detect risankizumab-800CW signals_1","Investigate the feasibility of using FME to detect risankizumab-800CW signals_2","Investigate the feasibility of using FME to detect risankizumab-800CW signals_3","Determining the optimal imaging dose of risankizumab-800CW"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["groningen-netherlands"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Risankizumab-800CW 4.5 mg for Ulcerative Colitis (UC)","inPlainEnglish":"Crohn\\&#39;s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Risankizumab is a human monoclonal antibody against IL23 p19, part of a pro-inflammatory cytokine that mediates the inflammatory response in IBD upon binding to its receptor.","whoItsFor":["Ages 18 Years to any","Established IBD diagnosis","Active disease: clinically active disease of the bowel is defined clinically as at least mild activity using dedicated scoring indices or biochemically active disease as defined by a fecal calprotectin \\&gt; 60 μg/g","Patients must be eligible for risankizumab therapy","Minimum age of 18 years","Clinical indication for an endoscopic procedure","who can join for part B:","Patients must be on risankizumab therapy for at least 14 weeks"],"whoShouldSkip":["A female study patient who is pregnant or provides breastfeeding","A female study patient of premenopausal age who does not use any reliable form of contraception at the time of risankizumab-800CW administration and the following 10 weeks","Prior anti-IL23-specific therapy (IL23/IL12 combination therapy is not an"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab-800CW 4.5 mg, Risankizumab-800CW 15 mg, or Risankizumab-800CW 25 mg. The registry lists allocation as randomized. Crohn\\&#39;s Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 18 people at Groningen. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.587Z"},{"nctId":"NCT06611618","title":"Analysis of the Loss of Muscle Force, Power and Motor Control to Predict the Risk of Falls in Patients With Knee OA","officialTitle":"Analisi Della Perdita di Forza e Potenza Muscolare e Del Degrado Del Controllo Motorio Per la Predizione Delle Cadute in Una Popolazione Affetta da Artrosi di Ginocchio","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Istituto Ortopedico Rizzoli","sponsorClass":"OTHER","summary":"The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is:\n\n● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population?\n\nParticipants will undergo:\n\n* Muscle force assessment on a dynamometer\n* Muscle power assessment on a dynamometer and on isntrumented stairs\n* Home-based mobility monitoring\n* Full lower limb MRI acquisition\n* Gait assessment","conditions":["Knee Osteoarthritis (Knee OA)","Falls Prevention"],"keywords":["Falls prevention","Knee osteoarthritis","Muscle power","Muscle force","Motor control degradation","digital twins","IMU","mobility monitoring","MRI"],"interventions":[{"type":"OTHER","name":"Muscle power assessment"},{"type":"OTHER","name":"Muscle force assessment"},{"type":"OTHER","name":"Home-based mobility monitoring"},{"type":"DIAGNOSTIC_TEST","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Gait assessment"}],"enrollment":50,"startDate":"2025-01-30","completionDate":"2028-12-31","sex":"ALL","minAge":"65 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 65 and 80 years\n* Kellgren score II e III\n* No history of falls in the last 12 months\n\nExclusion Criteria:\n\n* Any musculoskeletal, neurological, rheumatic or tumoral diseases\n* Dementia\n* Diabetes\n* Inguinal or abdominal hernia\n* Severe Hypertension (Level 3)\n* Severe Cardio-pulmonary insufficiency\n* Diagnosis of Osteonecrosis in the lower limb joints\n* Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)\n* Previous interventions or traumas to the joints of the lower limb","locations":[{"facility":"IRCCS Istituto Ortopedico Rizzoli","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Berti, Professor","phone":"+390516366529","email":"lisa.berti@ior.it"},{"name":"Massimiliano Baleani, Engineer","phone":"+390516366865","email":"massimiliano.baleani@ior.it"}],"primaryOutcomes":["Maximal muscle force","Muscle power","Muscle activations","Digital Mobility Outcomes"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["bologna-italy"],"enrichment":{"headline":"Not a traditional drug phase: Muscle power assessment for Knee Osteoarthritis (Knee OA)","inPlainEnglish":"The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling. The main question it aims to answer is: ● Are muscle power and motor control degradation better predictors of falls than muscle strength in the aging population?","whoItsFor":["Ages 65 Years to 80 Years","Age between 65 and 80 years","Kellgren score II e III","No history of falls in the last 12 months"],"whoShouldSkip":["Any musculoskeletal, neurological, rheumatic or tumoral diseases","Inguinal or abdominal hernia","Severe Hypertension (Level 3)","Severe Cardio-pulmonary insufficiency","Diagnosis of Osteonecrosis in the lower limb joints","Pathologies or physical conditions incompatible with the use of magnetic resonance imaging and electrostimulation (i.e., active and passive implanted biomedical devices, epilepsy, severe venous insufficiency in the lower limbs)","Previous interventions or traumas to the joints of the lower limb"],"whatHappens":"If you join, the listed intervention(s) are Muscle power assessment, Muscle force assessment, or Home-based mobility monitoring. The registry lists allocation as na. The twofold goal of this study is to understand the link between muscle power, muscle strength, and muscle control degradation with the risk of falling, and to develop a framework for the comprehensive and quantitative assessment of muscle power (and strength) in an elderly population of patients with knee osteoarthritis, who are at higher risk of falling.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Bologna. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.505Z"},{"nctId":"NCT06617325","title":"A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","officialTitle":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"UCB Biopharma SRL","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Systemic lupus erythematosus","Dapirolizumab pegol","SLE","DZP"],"interventions":[{"type":"DRUG","name":"DZP"},{"type":"OTHER","name":"Placebo"}],"enrollment":450,"startDate":"2024-11-21","completionDate":"2028-05-31","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Study participant must be ≥16 years of age, (≥18 years of age for China), unless restricted by local regulation, at the time of signing the Informed Consent form (ICF)\n* Study participants who have moderate to severe disease activity due to either persisting active systemic lupus erythematosus (SLE) or due to an acute worsening of SLE in the scope of frequent relapsing-remitting SLE despite stable standard of care(SOC) medication defined as:\n\n  a. Diagnosed with SLE at least 24 weeks before the Screening Visit by a qualified physician b. Classified by 2019 SLE European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE c. With serological evidence for SLE at Screening as demonstrated by at least 1 of the following: i) Evidence for anti-dsDNA (defined as evidence for anti-dsDNA antibodies in central laboratory) ii) Either complement C3 \\<lower limit of normal (LLN) OR complement C4 \\<LLN as measured by central laboratory iii) Antinuclear antibodies with a titer of at least 1:80 confirmed by central laboratory in combination with evidence of at least 1 of the following SLE typical autoantibodies:\n  1. Anti-Smith (anti-Sm) antibodies (central laboratory or source verifiable history)\n  2. Anti-Sjögren's syndrome antibody A (Anti-SSA) (Ro)/Anti-Sjögren's syndrome antibody B (anti-SSB) (La) autoantibodies (central laboratory)\n  3. Historical evidence for anti-dsDNA antibodies\n  4. Anti-ribonucleoprotein (RNP) autoantibodies (central laboratory) d. Moderately to severely active defined as:\n\n     * British Isles Lupus Assessment Group Disease Activity Index 2004 (BILAG 2004) Grade B in ≥2 organ systems and/or a BILAG 2004 Grade A in ≥1 organ systems at Screening and Baseline Visit AND\n     * Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ≥6 at the Screening Visit AND\n     * SLEDAI-2K without labs ≥4 at Baseline Visit e. Receiving the following standard of care (SOC) medications at stable dose:\n     * Antimalarial treatment in combination with glucocorticoids and/or immunosuppressants or as stand-alone treatment if justified OR\n     * Treatment with glucocorticoids and/or immunosuppressants if antimalarial treatment is not appropriate (ie, there is documented intolerance in medical history, documented lack of efficacy, contraindications, or lack of availability)\n\n     Exclusion Criteria:\n* Study participant has any medical or psychiatric condition (including conditions due to neuropsychiatric SLE) that, in the opinion of the Investigator, could jeopardize or would compromise the study participant's ability to participate in this study. This includes study participants with a life-threatening condition\n* Study participant has a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies. This includes systemic reactions due to latex allergy\n* Study participant has a history of malignancy, except the following treated cancers: cervical carcinoma in situ (after complete resection \\[eg, curettage, electrodesiccation\\] not later than 4 weeks prior to the Screening Visit \\[V1\\]), basal cell carcinoma, or dermatological squamous cell carcinoma\n* Study participant has a mixed connective tissue disease, scleroderma, and/or overlap syndrome of these diseases with SLE\n* Study participant has evidence of human immunodeficiency virus (HIV) infection, agammaglobulinemias, T-cell deficiencies, or human T-cell lymphotropic virus-1 infection at any time prior to or during the study\n* Study participant has clinically significant active or latent infection\n* Study participant had a reactivated latent infection (eg, cytomegalovirus, herpes simplex virus, or herpes zoster infection) or opportunistic infection (including but not limited to, pneumocystis, cytomegalovirus, or severe herpes zoster infection) within 12 weeks prior to the first study medication infusion (Visit 2) or is currently receiving suppressive therapy for an opportunistic infection\n* Study participants who have received live/live attenuated vaccines within 6 weeks prior to the first study medication infusion\n* Study participant has used the prohibited medications within the time frame (Wash-Out Period) listed in the Protocol\n* Study participant has previously been randomized within this study or has previously been assigned to treatment with dapirolizumab pegol (DZP) in a study evaluating DZP\n* Study participant has participated in another study of an investigational medicinal product (IMP) within the previous 12 weeks or 5 half-lives of the IMP whatever is longer, or is currently participating in another study of an IMP\n* Study participant has chronic kidney failure stage 4, manifested by estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73m2, or serum creatinine \\>2.5 mg/dL, 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Site","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Lutsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Uzhhorod","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Vinnytsia","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xencor Investigative Site","city":"Zhytomyr","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"942 Study Information","phone":"","email":"Xenith-UCinfo@xencor.com"}],"primaryOutcomes":["Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part A)","Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of XmAb942 in healthy volunteers (Part B)","Clinical remission based on modified mayo score (MMS), defined as MMS ≤ 2 with Mayo endoscopic score (MES) of 1, rectal bleeding subscore (RBS) of 0, and stool frequency subscore (SFS) of 0-1."],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","palo-alto-california","bradenton-florida","brandon-florida","jacksonville-florida","kissimmee-florida","margate-florida","palmetto-bay-florida","tampa-florida","louisville-kentucky","oxford-mississippi","tupelo-mississippi","albany-new-york","rochester-new-york","raleigh-north-carolina","beavercreek-ohio","cordova-tennessee","cedar-park-texas","denton-texas","garland-texas","georgetown-texas","houston-texas","kingwood-texas","lubbock-texas","san-antonio-texas","tyler-texas","webster-texas","richmond-virginia","buenos-aires-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","adelaide-australia","brisbane-australia","joondalup-australia","macquarie-park-australia","melbourne-australia","nedlands-australia","south-brisbane-australia","southport-australia","wollongong-australia","campinas-brazil","caxias-do-sul-brazil","fortaleza-brazil","maca-brazil","porto-alegre-brazil","salvador-brazil","santo-andr-brazil","s-o-paulo-brazil","votuporanga-brazil","sofia-bulgaria","london-canada","montreal-canada","scarborough-canada","vancouver-canada","santiago-chile","osijek-croatia","rijeka-croatia","zagreb-croatia","tbilisi-georgia","athens-greece","heraklion-greece","thessaloniki-greece","budapest-hungary","ny-regyh-za-hungary","v-c-hungary","amman-jordan","irbid-jordan","beirut-lebanon","tripoli-lebanon","chisinau-moldova","bydgoszcz-poland","katowice-poland","krakow-poland","nowy-targ-poland","sopot-poland","stasz-w-poland","szczecin-poland","warsaw-poland","wroclaw-poland","loures-portugal","bucharest-romania","bragadiru-romania","cluj-napoca-romania","ploie-ti-romania","timi-oara-romania","barcelona-spain","valencia-spain","ivano-frankivsk-ukraine","kyiv-ukraine","lutsk-ukraine","lviv-ukraine","uzhhorod-ukraine","vinnytsia-ukraine","zhytomyr-ukraine"],"enrichment":{"headline":"Phase 1 / Phase 2: testing XmAb942 for Ulcerative Colitis (UC)","inPlainEnglish":"The Phase 1 study described herein will measure the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B). Part C of this study will be a Phase 2 study to evaluate XmAb942 in participants with ulcerative colitis (UC).","whoItsFor":["Ages 18 Years to 75 Years","Must be in good health with no significant medical history","Clinical laboratory values within normal range","body-mass index (BMI) 18-35 (inclusive)","Contraceptive use by men or women consistent with local regulations","UC diagnosis ≥ 3 months prior to screening","Diagnosis of moderately to severely active UC as defined by a (MMS) ≥ 5, with a MES ≥ 2 and RBS ≥ 1","Evidence of UC extending ≥ 15 cm from the anal verge, as determined by screening colonoscopy"],"whoShouldSkip":["Any physical or psychological condition that prohibits study completion","History of suicidal behavior or suicidal ideation","Heavy use of nicotine containing products","HIV, hepatitis B and hepatitis C positive","Cardiac arrhythmia, or clinically significant abnormal ECG","Active use of prescription medications within 14 days of Day -1","Active use of over-the-counter, or herbal medication within 7 days of Screening"],"whatHappens":"If you join, the listed intervention(s) are XmAb942, or Placebo. The registry lists allocation as randomized. The Phase 1 study described herein will measure the safety, tolerability, pharmacokinetics and pharmacodynamics of XmAb942 in healthy volunteers (Parts A and B).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 270 people at 95 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.216Z"},{"nctId":"NCT06623422","title":"A Study of Pembrolizumab (MK-3475) With or Without Intismeran Autogene (V940) in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)","officialTitle":"A Phase 3 Randomized Double-blind Study of Adjuvant Pembrolizumab With or Without V940 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy (INTerpath-009)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive placebo and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).","conditions":["Carcinoma, Non-Small-Cell Lung"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Individualized neoantigen therapy (INT)"],"interventions":[{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Paclitaxel"},{"type":"BIOLOGICAL","name":"Intismeran autogene"},{"type":"OTHER","name":"Placebo"}],"enrollment":680,"startDate":"2024-10-21","completionDate":"2033-05-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \\[American Joint Committee on Cancer (AJCC) 8th Edition\\]\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention\n* Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible\n* Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \\[eg, DEL19 or L858R\\])\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor\n* Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements\n* Received prior neoadjuvant therapy for their current NSCLC diagnosis\n* Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein \\[CTLA-4\\], OX-40, CD137)\n* Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol\n* Received prior treatment with a cancer vaccine\n* Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention","locations":[{"facility":"Banner MD Anderson Cancer Center ( Site 0181)","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Arizona Cancer Center - North Campus ( Site 0163)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence St. Jude Medical Center ( Site 0106)","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VA Long Beach Healthcare System ( Site 0199)","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Comprehensive Cancer Center ( Site 0205)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Jonsson Comprehensive Cancer Center ( Site 0135)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center at Mission Bay ( Site 0178)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus ( Site 0151)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Memorial Hospital Central ( Site 0125)","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center at North Colorado Medical Center ( Site 0207)","city":"Greeley","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centura Health - St. Anthony North Health Campus ( Site 0189)","city":"Westminster","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine ( Site 0201)","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern CT Hematology & Oncology Associates ( Site 0202)","city":"Norwich","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0156)","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute at Baptist Health, Inc. ( Site 0214)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beacon Cancer Care ( Site 0127)","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago Medical Center ( Site 0118)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Cancer Care ( Site 8107)","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscan Health ( Site 0219)","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Oncology Hematology (MOH) ( Site 8102)","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital ( Site 0136)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Hospital ( Site 0155)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ellis Fischel Cancer Center ( Site 0133)","city":"Columbia","state":"Missouri","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lake Regional Hospital-Cancer Center ( Site 0123)","city":"Osage Beach","state":"Missouri","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute ( Site 0184)","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology-Oncology Associates of CNY ( Site 0164)","city":"East Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0216)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai ( Site 0116)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center ( Site 0137)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Cancer Center ( Site 0140)","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center ( Site 0160)","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westchester Medical Center ( Site 0196)","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Weisiger Cancer Insititute ( Site 0266)","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Forsyth Medical Center ( Site 0166)","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center ( Site 0119)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0217)","city":"Corvallis","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Lukes Hospital and Health Network ( Site 0186)","city":"Bethlehem","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology, PLLC - Chattanooga Downtown ( Site 0315)","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thompson Cancer Survival Center ( Site 0168)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Clinical Research Institute, Inc. ( Site 9501)","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elliston Place Medical Oncology & Hematology ( Site 0215)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8103)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center ( Site 0190)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Cancer Center ( Site 0191)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center ( Site 0150)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hermann Cancer Center ( Site 0172)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michael E. DeBakey VA Medical Center ( Site 0197)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"O'Quinn Medical Tower at McNair Campus ( Site 0131)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0148)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists ( Site 0167)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates (VOA) ( Site 8101)","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Health Adult Outpatient Pavillion ( Site 0193)","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute ( Site 0143)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Medical Center Hematology and Oncology - Silverdale ( Site 0192)","city":"Silverdale","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEMIC ( Site 2454)","city":"Caba.","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 2459)","city":"Ciudad Autonoma de Buenos Aires.","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Intecnus ( Site 2456)","city":"Bariloche","state":"Río Negro Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Médico IPAM ( Site 2452)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Medico Especializado Alexander Fleming ( Site 2457)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oncologico de Cordoba -IONC ( Site 2455)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Calvary Mater Newcastle ( Site 2106)","city":"Waratah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tasman Oncology Research ( Site 2104)","city":"Southport","state":"Queensland","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital ( Site 2102)","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grampians Health ( Site 2101)","city":"Ballarat","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"One Clinical Research ( Site 2103)","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc ( Site 1203)","city":"Brussels","state":"Bruxelles-Capitale, Region de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jessa Ziekenhuis ( Site 1204)","city":"Hasselt","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent ( Site 1201)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 2502)","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Araújo Jorge ( Site 2514)","city":"Goiânia","state":"Goiás","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Cancer ( Site 2513)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Tacchini ( Site 2506)","city":"Bento Gonçalves","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Clínicas de Passo Fundo ( Site 2504)","city":"Passo Fundo","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Moinhos de Vento ( Site 2510)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nossa Senhora Da Conceicao ( Site 2512)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia Saint Gallen ( Site 2507)","city":"Santa Cruz do Sul","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Amor - Barretos ( Site 2511)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Câncer - INCA ( Site 2501)","city":"Rio de Janeiro","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"MBAL Uni Hospital ( Site 1253)","city":"Panagyurishte","state":"Pazardzhik","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"MHAT - Heart and Brain ( Site 1252)","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth II Health Sciences Centre ( Site 1101)","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamilton Health Sciences - Juravinski Site 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3: testing Pembrolizumab for Carcinoma, Non-Small-Cell Lung","inPlainEnglish":"The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive dummy treatment (placebo) and pembrolizumab. Researchers want to know if giving intismeran autogene and pembrolizumab after surgery can help prevent the cancer from coming back in people with non-small cell lung cancer (NSCLC) whose tumors did not respond completely to treatment before surgery (neoadjuvant treatment).","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable clinical Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) \\[American Joint Committee on Cancer (AJCC) 8th Edition\\]","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention","Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible","Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations \\[eg, DEL19 or L858R\\])","Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART)","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, Cisplatin, or Carboplatin. The registry lists allocation as randomized. The goal of this study is to learn if people who receive intismeran autogene and pembrolizumab after surgery are cancer-free longer than people who receive dummy treatment (placebo) and pembrolizumab.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 680 people at 246 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.666Z"},{"nctId":"NCT06624670","title":"A Study to Test Whether Spesolimab Helps People With a Skin Condition Called Pyoderma Gangrenosum","officialTitle":"A Multi-centre, Randomised, Placebo-controlled, Double-blind, Parallel-group Trial to Evaluate Safety and Efficacy of Spesolimab (BI 655130) in Adult Patients With Ulcerative Pyoderma Gangrenosum (PG) Who Require Systemic Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"LEO Pharma","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers. This study is open to adults with ulcerative PG with at least 1 ulcer that measures between 5 cm\\^2 to 80 cm\\^2 in size.\n\nThis study has 2 parts. In Part 1, participants are put into groups randomly, which means by chance. 1 group gets spesolimab and the other group gets placebo. Placebo infusions look like spesolimab infusions, but do not contain any medicine. Every participant has a 2 in 3 chance of getting spesolimab. For the first 8 weeks, participants also take corticosteroid medicine by mouth.\n\nIn Part 2, participants are put into groups again. Participants without open ulcers have an equal chance of getting spesolimab or placebo. Participants with open skin ulcers will get spesolimab.\n\nIn both parts, participants receive spesolimab or placebo as an infusion into a vein every 4 weeks.\n\nParticipants are in the study for about 1.5 years. During this time, they visit the study site 20 times. At study visits, doctors check the participant's skin for signs of PG. The doctors also regularly check participants' health and take note of any unwanted effects. The results of the groups are compared to see whether the treatment works.","conditions":["Pyoderma Gangrenosum"],"keywords":[],"interventions":[{"type":"DRUG","name":"Spesolimab"},{"type":"DRUG","name":"Placebo matching to spesolimab"},{"type":"DRUG","name":"Prednisone"},{"type":"DRUG","name":"Prednisolone"}],"enrollment":90,"startDate":"2025-02-05","completionDate":"2027-11-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening.\n2. Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial.\n3. A confirmed diagnosis of ulcerative pyoderma gangrenosum (PG) (≥10 points on the PARACELSUS score) that requires systemic therapy in the opinion of the investigator. The diagnosis needs to be confirmed by an Adjudication Committee. Trial participants with mixed PG subtypes are eligible as long as the target lesion is of the ulcerative subtype.\n4. At least one measurable (defined as measuring ≥5 cm\\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee.\n5. At the time of the Screening Visit, a maximum duration of 6 months since the target ulcer in the current PG episode was diagnosed. Target ulcers \\>6 months since diagnosis are allowed if they are active and progressing, as judged by the investigator and confirmed by an Adjudication Committee.\n6. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information and in the protocol.\n\nExclusion criteria:\n\n1. Trial participants with non-PG lesions.\n2. Trial participants with a target PG ulcer measuring \\>80 cm\\^2.\n3. Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee.\n4. Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment.\n5. Presence of persistent or recurring bacterial infection requiring systemic antibiotic therapy; or clinically significant viral, fungal, or parasitic infections within 2 weeks prior to the Screening Visit. Any such infection must be resolved, with treatment completed ≥2 weeks prior to the Screening Visit. No new/recurrent infections should have occurred prior to Visit 2.\n6. \"Active or latent tuberculosis (TB)\n\n   * Participants with active TB are excluded\n   * Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial.\"\n7. Chronic or acute infections including Human immunodeficiency virus (HIV) infections and viral hepatitis (including occult hepatitis); the corresponding laboratory tests will be performed during screening. A trial participant can be re-screened if the trial participant was treated and is cured from the acute infection.\n8. Severe, progressive, or uncontrolled hepatic disease, defined as \\>3x Upper Limit of Normal (ULN) elevation in Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) or alkaline phosphatase, or \\>2x ULN elevation in total bilirubin.\n\nFurther exclusion criteria apply.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Dermatology Specialists Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South 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Technology","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Second Affiliated Hospital of medical college of Xi'an JiaoTong University","city":"Xi'an","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"HUS Tulehduskeskus /Ihosairauksien linja","city":"Helsinki","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Privé Antony","city":"Antony","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Edouard Herriot","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital de l'Archet","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Saint-Louis","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité - Universitätsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Düsseldorf","city":"Düsseldorf","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Erlangen","city":"Erlangen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Essen AöR","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Freiburg","city":"Freiburg im Breisgau","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg, Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Würzburg AÖR","city":"Würzburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Pisana","city":"Pisa","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituti Fisioterapici Ospitalieri","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Policlinico Umberto I","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas","city":"Rozzano (MI)","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino","city":"Torino","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujita Health University Hospital","city":"Aichi, Toyoake","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital","city":"Hokkaido, Sapporo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hyogo College of Medicine Hospital","city":"Hyogo, Nishinomiya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mie University Hospital","city":"Mie, Tsu","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tohoku University Hospital","city":"Miyagi, Sendai","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jichi Medical University Hospital","city":"Tochigi, Shimotsuke","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teikyo University Hospital","city":"Tokyo, Itabashi-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nihon University Itabashi Hospital","city":"Tokyo, Itabashi-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Raja Permaisuri Bainun","city":"Ipoh","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarawak General Hospital","city":"Kuching","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Pulau Pinang-Pulau Pinang-21953","city":"Pulau Pinang","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo Universitetssykehus HF, Rikshospitalet","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helse Stavanger, Stavanger Universitetssykehus","city":"Stavanger","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Military Medical Institute- National Research Institute","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cityclinic Medical and Psychological Clinic Matusiak Partnership","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHUC - Centro Hospitalar e Universitario de Coimbra, EPE","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"ULS de São José, E.P.E. - Hospital Sto. António Capuchos","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"ULS de Santa Maria, E.P.E","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"ULS de Santo Antônio, E.P.E - Centro Hospitalar Universitário de Santo António","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital del Mar","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon Y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karolinska Universitetssjukhuset Solna","city":"Stockholm","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Zurich","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Chang Gung Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation (CGMF) - Linkou Bran","city":"Linkou District","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Disclosure","phone":"+45 4494 5888","email":"clinicaldisclosure@leo-pharma.com"}],"primaryOutcomes":["Achievement of complete closure (PGAR-100 (100% pyoderma gangrenosum area reduction)) of the target PG ulcer at any time up to Week 26 and confirmed at the next consecutive visit (at least 2 weeks later)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","irvine-california","miami-florida","tampa-florida","sandy-springs-georgia","meridian-idaho","chicago-illinois","indianapolis-indiana","new-orleans-louisiana","boston-massachusetts","ann-arbor-michigan","flint-michigan","kansas-city-missouri","lees-summit-missouri","st-louis-missouri","lebanon-new-hampshire","lake-success-new-york","new-york-new-york","fargo-north-dakota","cleveland-ohio","columbus-ohio","portland-oregon","philadelphia-pennsylvania","lewisville-texas","murray-utah","caba-argentina","rosario-argentina","darlinghurst-australia","st-leonards-australia","westmead-australia","melbourne-australia","graz-austria","salzburg-austria","leuven-belgium","bras-lia-brazil","santo-andr-brazil","edmonton-canada","toronto-canada","montreal-canada","qu-bec-canada","beijing-china","changchun-china","changsha-china","chengdu-china","hangzhou-china","jinan-china","shanghai-china","shenzhen-china","wuhan-china","xian-china","helsinki-finland","antony-france","lyon-france","nice-france","paris-france","berlin-germany","d-sseldorf-germany","erlangen-germany","essen-germany","freiburg-im-breisgau-germany","hamburg-germany","t-bingen-germany","w-rzburg-germany","milan-italy","pisa-italy","roma-italy","rozzano-mi-italy","torino-italy","aichi-toyoake-japan","hokkaido-sapporo-japan","hyogo-nishinomiya-japan","mie-tsu-japan","miyagi-sendai-japan","tochigi-shimotsuke-japan","tokyo-itabashi-ku-japan","ipoh-malaysia","kuching-malaysia","pulau-pinang-malaysia","oslo-norway","stavanger-norway","warsaw-poland","wroclaw-poland","coimbra-portugal","lisbon-portugal","porto-portugal","barcelona-spain","madrid-spain","m-laga-spain","stockholm-sweden","zurich-switzerland","kaohsiung-city-taiwan","linkou-district-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 3: testing Spesolimab for Pyoderma Gangrenosum","inPlainEnglish":"This study wants to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG). The main aim is to see whether spesolimab leads to closure of PG ulcers.","whoItsFor":["Ages 18 Years to any","Adult trial participants, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening","At least one measurable (defined as measuring ≥5 cm\\^2) PG ulcer. In trial participants with more than one PG ulcer, the target PG ulcer will be selected by the investigator and confirmed by external Adjudication Committee"],"whoShouldSkip":["Trial participants with non-PG lesions","Trial participants with a target PG ulcer measuring \\>80 cm\\^2","Trial participants with chronic, non-inflamed PG wounds or ulcers that are not responsive to immunosuppressive therapy, as determined by an Adjudication Committee","Presence of active ulcer infection at the Screening Visit (unless treated and resolved prior to administration of the first dose of trial medication) based on investigator assessment","\"Active or latent tuberculosis (TB)","Participants with active TB are excluded","Participants with latent TB may be included if treatment of latent TB, as per local guidelines, is initiated prior to randomization and completed during the course of the trial.\""],"whatHappens":"If you join, the listed intervention(s) are Spesolimab, Placebo matching to spesolimab, or Prednisone. The registry lists allocation as randomized. This study wants to find out whether a medicine called spesolimab helps people with pyoderma gangrenosum (PG).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 90 people at 104 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.837Z"},{"nctId":"NCT06629649","title":"Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers","officialTitle":"Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Alabama at Birmingham","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment). The glaucoma screening will incorporate use of an artificial intelligence (AI)-assisted screening tool. This project is called AI-RONA. The main questions it aims to answer are:\n\n* How does this eye screening program compare to the rate of glaucoma and other eye conditions detected at other FQHC clinics where the screening program has not been implemented?\n* Do particpants who screen positive for these conditions adhere to the physician's recommendation for a follow-up examination by an optometrist or ophthalmologist?\n* Are referral rates for a follow-up comprehensive eye exam by an optometrist or ophthalmologist similar to those implemented by an ophthalmologist using telemedicine (that is, using the results of the screening to make a diagnosis remotely)?\n* What is the cost-effectiveness of the AI-assisted screening program in diagnosing glaucoma as compared to a physician-guided program?\n* Are participants completing the screening satisfied with it?\n* Are physicians at the FQHC clinics administering the screening satisfied with it?\n\nParticipants will:\n\n* Undergo an ocular screening whose goal is to detect glaucoma, diabetic retinopathy, cataract, and/or impairment in visual acuity. If the screening indicates that participants may have these conditions, participants will be referred for a comprehensive eye examination by an optometrist or ophthalmologist.\n* Following the screening, participants and physicians will complete a survey on their satisfaction with the program.","conditions":["Glaucoma","Ocular Hypertension"],"keywords":["visual acuity impairment","glaucoma","ocular hypertension","glaucoma suspect","diabetic retinopathy","cataract"],"interventions":[{"type":"OTHER","name":"Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment."}],"enrollment":1800,"startDate":"2025-10-22","completionDate":"2029-09-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* African American or Hispanic persons ≥ 40 years old\n* Non-Hispanic white persons ≥ 50 years old\n* Anyone ≥ 18 years old with diabetes type 1 or type 2\n* Anyone ≥ 18 years old who already has a glaucoma associated disease\n* Anyone ≥ 18 years old with a family history of glaucoma\n\nExclusion Criteria:\n\n* Cannot communicate in English","locations":[{"facility":"Department of Ophthalmology and Visual Sciences, University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cynthia Owsley, PhD","phone":"205-325-8635","email":"cynthiaowsley@uabmc.edu"},{"name":"Dawn Matthies, PhD","phone":"205-325-8631","email":"dmatthies@uabmc.edu"}],"primaryOutcomes":["Rate of participants where the glaucoma screening protocol leads to a screening diagnosis of glaucoma","Rate of participants who decide to attend the follow up exam by optometrist or ophthalmologist","Rate of participants where the screening protocol leads to a screening diagnosis of cataract, diabetic retinopathy, or visual acuity impairment","Compare cost of screening program in FQHC to the cost of an ophthalmologist or optometrist guided assessment"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["birmingham-alabama"],"enrichment":{"headline":"Not a traditional drug phase: Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment. for Glaucoma","inPlainEnglish":"The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment). The glaucoma screening will incorporate use of an artificial intelligence (AI)-assisted screening tool.","whoItsFor":["Ages 18 Years to any","African American or Hispanic persons ≥ 40 years old","Non-Hispanic white persons ≥ 50 years old","Anyone ≥ 18 years old with diabetes type 1 or type 2","Anyone ≥ 18 years old who already has a glaucoma associated disease","Anyone ≥ 18 years old with a family history of glaucoma"],"whoShouldSkip":["Cannot communicate in English"],"whatHappens":"If you join, the listed intervention(s) are Glaucoma screening using an AI-algorithm and screening for diabetic retinopathy, cataract, and visual acuity impairment.. The registry lists allocation as randomized. The goal of this clinical trial is to learn if implementation of an eye screening program at Federally Qualified Health Center (FQHC) clinics provides results that participants may have glaucoma, and/or other eye conditions (diabetic retinopathy, cataract, visual acuity impairment).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,800 people at Birmingham. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.042Z"},{"nctId":"NCT06631287","title":"Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID","officialTitle":"Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID (REVERSE-LC)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Wes Ely","sponsorClass":"OTHER","summary":"The overarching goal of this study is to determine if baricitinib, as compared to placebo, will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.","conditions":["Long COVID","Sars-CoV-2 Infection","Coronavirus Infections","COVID-19"],"keywords":["COVID-19","Long COVID Drug Treatment","Long COVID"],"interventions":[{"type":"DRUG","name":"Baricitinib"},{"type":"OTHER","name":"Placebo"}],"enrollment":550,"startDate":"2024-10-21","completionDate":"2026-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this investigation, an individual must meet all of the following criteria:\n\nCohort #1 (n=500):\n\n1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.\n2. Age ≥18 years old.\n3. Documented SARS-CoV-2 infection 6 or more months prior to screening, confirmed with acceptable documentation that includes (at minimum) their name, the date the test was taken (must be after January 2020), and details specifying that the positive test was for SARS-CoV-2 infection.\n4. Clinical evidence of Long COVID, as confirmed by the investigator's assessment:\n\n   a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).\n\n   i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory/concentration (\"brain fog\"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.\n\n   b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.\n\n   c. Symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome.\n\n   d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.\n\nCohort #2 (n=50):\n\n1. Evidence of personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study and was willing and able to consent to participation.\n2. Age ≥18 years old.\n3. Clinical diagnosis of COVID infection between January 2020 and September 1, 2021 (i.e., before home tests were widely available).\n\n   a. Clinical Criteria (Based on Council of State and Territorial Epidemiologists Standardized Surveillance Case Definition for COVID-19): i. At least two of the following symptoms: Fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, new olfactory and taste disorder(s).\n\n   -OR- ii. At least one of the following symptoms: Cough, shortness of breath, or difficulty breathing.\n\n   -OR- iii. Severe respiratory illness with at least one of the following: clinical or radiographic evidence of pneumonia or Acute Respiratory Distress Syndrome (ARDS).\n\n   -AND- iv. No alternate more likely diagnosis\n4. Clinical evidence of Long COVID, as confirmed by the clinician's assessment:\n\n   a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent).\n\n   i. Systemic symptoms (e.g., fatigue, chills, post-exertional malaise), neurocognitive symptoms (e.g., trouble with memory/concentration (\"brain fog\"), headache, dysautonomia/postural orthostatic tachycardia syndrome, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (e.g., chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (e.g., muscle aches, joint pain), gastrointestinal symptoms (e.g., nausea, diarrhea). Although other symptoms (e.g., skin rash, hair loss, mental health symptoms, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least one core symptoms listed above must be present.\n\n   b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening.\n\n   c. Symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome.\n\n   d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this investigation:\n\n1. Qualifying Long COVID symptoms cannot be explained by an infection-associated chronic condition diagnosed prior to the onset of Long COVID (e.g., ME/CFS or other infection-associated chronic condition).\n2. Pre-existing cognitive impairment not exacerbated by COVID-19, including but not limited to syphilis, as determined by study clinicians (MD, DO, NP, PA, RN, or equivalent), which may include a review of participant's history and medical records.\n3. Severe cognitive, physical, or psychological disability preventing participation in the study, as determined by the investigator.\n4. Moderate or High risk of suicidality, as determined by the modified Columbia Suicide Severity Rating Scale (mC-SSRS).\n5. History of a major adverse cardiovascular event (MACE) within the 3 months prior to enrollment.\n6. Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs); however, DMARDs with minimal immunomodulatory effects (hydroxychloroquine, i.e., Plaquenil, steroids used for less than 2 weeks, minocycline), are not exclusionary.\n7. Known prior allergic reactions to components of the baricitinib.\n8. Previously randomized in this study or in the last 30 days have been in another study investigating baricitinib.\n9. Positive SARS-CoV-2 NAAT or rapid Antigen test in the 14 days prior to screening.\n10. Venous thromboembolism in the past 6 months prior to screening or felt to be at increased risk of thrombosis by the investigator.\n11. Malignancy or lymphoproliferative disorder not in remission for at least 5 years. Local non-melanoma skin cancers that are definitively managed are not exclusionary.\n12. Previous admission to an ICU for treatment of acute COVID-19 infection.\n13. Estimated glomerular filtration rate of \\< 30 mL/min/1.73m2, as calculated using the CKD-EPI 2021 equation.\n14. Absolute Neutrophil Count (ANC) \\<1000 cells/mm3, confirmed on repeat testing.\n15. Absolute Leukocyte Count (ALC) \\<100 cells/mm3.\n16. Evidence of severe liver disease at the time of screening, defined as Bilirubin \\> 1.5 X ULN or AST or ALT \\> 2x ULN.\n17. Alkaline Phosphatase (ALP) ≥ 3x ULN.\n18. Creatine Phosphokinase (CPK) ≥ 3x ULN.\n19. Hemoglobin (HgB) \\< 8 g/dL, confirmed on repeat testing.\n20. Platelets \\<100,000 cells/mm3, confirmed on repeat testing.\n21. Platelets \\>500,000 cells/mm3, confirmed on repeat testing.\n22. Total fasting cholesterol ≥ 280 mg/dL, confirmed on repeat testing.\n23. Fasting LDL ≥ 180 mg/dL, confirmed on repeat testing.\n24. Positive Hepatitis B surface antigen or Hepatitis B core antibody. Note: Individuals with a positive Hepatitis B core antibody will be excluded even in the presence of a positive Hepatitis B surface antibody due to the risk of reactivation.\n25. Positive for Hepatitis C at the time of Screening. Note: treated or cleared Hepatitis C is not exclusionary.\n26. Symptomatic herpes zoster infection (i.e., visible herpetic skin lesions of Zoster) within 3 months prior to study screening, or any history of disseminated/complicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis).\n27. History of untreated latent tuberculosis infection (diagnosed with QuantiFERON-TB Gold Plus testing) or active tuberculosis whether treated or untreated. Note: those with a positive PPD who have a history of BCG vaccine and a negative QuantiFERON-TB Gold Plus test will remain eligible).\n28. History of current or recent (\\< 30 days from screening) sepsis or clinically significant viral, bacterial, fungal, or parasitic infection, according to the determination of the investigator.\n29. Participants with HIV will be excluded if they have been on ART \\<1 year, have a CD4+ T cell count \\<500 cells/ml (confirmed on repeat), or have two consecutive HIV plasma RNA viral load \\> 48 copies/mL within 1 year of study screening, including requiring the most recent within 3 months of screening. Blips (VL \\> 48 copies/mL but \\< 200 copies/mL) are permitted if preceded and followed by values below the assay limit of quantification.\n30. Immunocompromised as defined by NIH COVID-19 guidelines (see Appendix) and, in the opinion of the investigator, at an unacceptable risk for participating in the study.\n31. Treatment with another investigational drug or device as part of an interventional study within 30 days of study screening.\n32. In the opinion of the investigator, unable to reliably follow-up for the duration of the study and/or are unable to follow study restrictions/procedures.\n33. Persons of childbearing potential under age 55 who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening though at least 28 days after the end of the study intervention period. Note: Acceptable methods include barrier contraceptives (condoms or diaphragm) with spermicide, intrauterine devices (IUDs), other contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about risks related to pregnancy or breastfeeding.\n34. Currently pregnant or breastfeeding or planning to become pregnant or breastfeed during the course of the study.\n35. Participants actively breastfeeding, who are unwilling to stop breastfeeding for the duration of the trial.\n36. Currently incarcerated\n\nNOTE RE: History of major adverse cardiovascular event (MACE) or traditional risk factors including smoking. For REVERSE-LC, MACE is defined as acute myocardial infarction and stroke. The study team will discuss the risks and benefits of baricitinib and CV events with the participant prior to study entry.\n\nNOTE RE: EBV/CMV Seropositivity - The investigators will not exclude participants based on EBV or CMV seropositivity. The investigators already know that serologic evidence suggesting recent EBV reactivation is associated with Long COVID fatigue and high level EBV responses are associated with neurocognitive Long COVID, but that EBV viremia and IgM is rare. The investigators believe there is equipoise with regard to the potential effects of baricitinib on EBV - it is as likely that inflammation drives EBV reactivation, just as EBV can drive inflammation. For this reason, the investigators think this is best studied as a biological factor correlated with outcomes and that the investigators should not deliberately include or exclude people based on this. CMV seropositivity is associated with improved Long COVID outcomes. Results are not required for screening.","locations":[{"facility":"University of Arizona","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles (UCLA)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado I Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida College of Medicine","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Research Network (ILLInet), University of Illinois Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health - Brooklyn","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Case Western","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The MetroHealth System","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia Clinical and Translational Science Institute","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amanda Bistran-Hall","phone":"615-343-8010","email":"vccrvlcstudy@vumc.org"},{"name":"Wes Ely, M.D.","phone":"","email":""}],"primaryOutcomes":["CNS-Vital Signs Global Cognitive Index"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["tucson-arizona","los-angeles-california","san-francisco-california","aurora-colorado","new-haven-connecticut","gainesville-florida","atlanta-georgia","chicago-illinois","boston-massachusetts","minneapolis-minnesota","brooklyn-new-york","cleveland-ohio","nashville-tennessee","san-antonio-texas","seattle-washington","morgantown-west-virginia"],"enrichment":{"headline":"Phase 3: testing Baricitinib for Long COVID","inPlainEnglish":"The overarching goal of this study is to determine if baricitinib, as compared to dummy treatment (placebo), will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.","whoItsFor":["Ages 18 Years to any","In order to be eligible to participate in this investigation, an individual must meet all of the following criteria:","Clinical evidence of Long COVID, as confirmed by the investigator's assessment:","a. At least one symptom (listed below) that is new or worsened since the time of SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the study clinicians (MD, DO, NP, PA, RN, or equivalent)","b. Symptoms must be present for at least 6 months prior to screening. Symptoms that wax and wane must have been initially present at least 6 months prior to screening","c. Symptoms must be reported to have an impact on quality of life and/or everyday functioning and to be at least somewhat bothersome","d. Cognitive impairment present defined by having at least 20% positive items (answered subjectively worse or much worse) on the 41-item modified ECog questionnaire","Clinical diagnosis of COVID infection between January 2020 and September 1, 2021 (i.e., before home tests were widely available)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this investigation:","Qualifying Long COVID symptoms cannot be explained by an infection-associated chronic condition diagnosed prior to the onset of Long COVID (e.g., ME/CFS or other infection-associated chronic condition)","Pre-existing cognitive impairment not exacerbated by COVID-19, including but not limited to syphilis, as determined by study clinicians (MD, DO, NP, PA, RN, or equivalent), which may include a review of participant's history and medical records","Severe cognitive, physical, or psychological disability preventing participation in the study, as determined by the investigator","Moderate or High risk of suicidality, as determined by the modified Columbia Suicide Severity Rating Scale (mC-SSRS)","History of a major adverse cardiovascular event (MACE) within the 3 months prior to enrollment","Current use of baricitinib or other disease-modifying antirheumatic drug (DMARDs); however, DMARDs with minimal immunomodulatory effects (hydroxychloroquine, i.e., Plaquenil, steroids used for less than 2 weeks, minocycline), are not exclusionary"],"whatHappens":"If you join, the listed intervention(s) are Baricitinib, or Placebo. The registry lists allocation as randomized. The overarching goal of this study is to determine if baricitinib, as compared to dummy treatment (placebo), will improve neurocognitive function, along with measures of physical function, quality of life, post-exertional malaise, effect of breathlessness on daily activities, post-COVID-19 symptom burden, and biomarkers of inflammation and viral measures, in participants with Long COVID.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 550 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.239Z"},{"nctId":"NCT06631638","title":"EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))","officialTitle":"Planned vs. Actual Acetabular Cup Position in Total Hip Arthroplasty With Non-Invasive Navigation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"DePuy Orthopaedics","sponsorClass":"INDUSTRY","summary":"The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software.\n\nData collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.","conditions":["Osteoarthritis","Traumatic Arthritis","Rheumatoid Arthritis","Congential Hip Dysplasia","Avascular Necrosis of the Femoral Head","Certain Cases of Ankylosis"],"keywords":[],"interventions":[{"type":"DEVICE","name":"EMPHASYS Cup with VHN"}],"enrollment":118,"startDate":"2025-10-24","completionDate":"2027-12-31","sex":"ALL","minAge":"21 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. All hip replacement component devices are to be used according to the approved indications.\n2. The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position.\n3. The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced\n4. Individuals who are able to speak, read, and comprehend the Informed Participant Consent Document and willing and able to provide consent for participation in the study and have authorized the transfer of his/her information to DePuy Synthes.\n5. Individuals who are willing and able to complete follow-up as specified by the study protocol.\n6. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol.\n7. Individuals who are not bedridden per the discretion of the investigator.\n8. Individuals who are a minimum age of 21 years at the time of consent\n\nExclusion Criteria:\n\n1. Active local or systemic infection.\n2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified.\n3. Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s).\n4. Charcot's or Paget's disease.\n5. The Subject is a woman who is pregnant or lactating.\n6. Subject had a contralateral amputation.\n7. Previous partial hip replacement in affected hip.\n8. Subject has participated in a clinical investigation with an investigational product (drug or device) in the last three months.\n9. Contralateral hip was replaced less than 6 months prior to surgery date.\n10. Subject is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.\n11. Subject was diagnosed and is taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.\n12. Subject has a medical condition with less than 2 years of life expectancy.\n13. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological disorder that could affect their ability to complete subject reported questionnaires or be compliant with follow-up requirements.","locations":[{"facility":"Florida Orthopaedic Institute","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Orthopaedic and Sports Medicine Center","city":"Gastonia","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Samantha Flamand","phone":"610-241-3260","email":"SFlamand@its.jnj.com"}],"primaryOutcomes":["Composite endpoint: Acetabular Cup Position Success at 6 Weeks"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis","osteoarthritis"],"drugSlugs":[],"locationSlugs":["gainesville-florida","gastonia-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: EMPHASYS Cup with VHN for Osteoarthritis","inPlainEnglish":"The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software. Data collected in this study will be compared with data collected from implantations using different cup positioning instrumentation and techniques to assess performance.","whoItsFor":["Ages 21 Years to any","All hip replacement component devices are to be used according to the approved indications","The subject is undergoing a standard of care primary uncemented hip replacement with the EMPHASYS cup and a CORAIL, EMPHASYS or ACTIS stem via the posterolateral, anterolateral, or direct lateral approach with the subject in the lateral decubitus position","The subject is a candidate for implantation utilizing the VELYS Hip Navigation system with CUPTIMIZE advanced","Individuals who are willing and able to complete follow-up as specified by the study protocol","Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., FJS-12, EQ-5D-5L and Hip Evaluation) as specified by the study protocol","Individuals who are not bedridden per the discretion of the investigator","Individuals who are a minimum age of 21 years at the time of consent"],"whoShouldSkip":["Active local or systemic infection","Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified","Poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s)","Charcot's or Paget's disease","The Subject is a woman who is pregnant or lactating","Subject had a contralateral amputation","Previous partial hip replacement in affected hip"],"whatHappens":"If you join, the listed intervention(s) are EMPHASYS Cup with VHN. The registry lists allocation as na. The purpose of this research is to gather clinical and radiographic (X-ray) information about EMPHASYS™ acetabular shell (also called a hip 'cup') placement in total hip replacement surgery using a non-invasive surgical navigation system called VELYS™ hip navigation system with CUPTIMIZE™ Advanced Hip-Spine Analysis software.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 118 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.955Z"},{"nctId":"NCT06632444","title":"LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis","officialTitle":"A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase III Trial Evaluating Long-term Efficacy and Safety of Survodutide Weekly Injections in Adult Participants With Noncirrhotic Non-alcoholic Steatohepatitis/Metabolic Dysfunction-associated Steatohepatitis (NASH/MASH) and (F2) - (F3) Stage of Liver Fibrosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults who are at least 18 years old living with obesity and have:\n\n* a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and\n* moderate or advanced liver fibrosis\n\nPeople with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.\n\nThis study has 2 parts. The purpose of the first part of this study is to find out the effect of survodutide on MASH and liver fibrosis. The purpose of the second part is to find out how safe and effective survodutide is in improving liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. The survodutide doses are slowly increased until the target dose is reached. All participants receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 7 years. During this time, they regularly visit the study site or have remote visits by video call. For about the first year of the study, participants have these visits every 2 weeks, increasing to every 4 weeks and then every 6 weeks. After being in the study for a little over a year participants will then alternate between visiting the study site or having a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight and effects on the stomach and intestines are regularly measured. At some visits the liver is measured using different imaging methods. At 2 or 3 visits doctors take a small sample of liver tissue (biopsy). The participants also fill in questionnaires about their symptoms and quality of life. The results are compared between the groups to see whether the treatment works.","conditions":["Metabolic Dysfunction Associated Steatohepatitis (MASH)","Liver Fibrosis"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Survodutide"},{"type":"COMBINATION_PRODUCT","name":"Placebo"}],"enrollment":1800,"startDate":"2024-10-14","completionDate":"2031-12-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent\n2. Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4\n3. Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used\n4. Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further inclusion criteria apply\n\nExclusion criteria:\n\n1. Any of the following liver laboratory test abnormalities at screening:\n\n   * Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)\n   * Platelet count \\<140 000/mm\\^3 (\\<140 GI/L)\n   * Alkaline phosphatase \\>2x upper limit of normal (ULN)\n   * Abnormal synthetic liver function as defined by screening central laboratory evaluation:\n\n     * Albumin below \\<3.5 g/dL (35.0 g/L)\n     * OR International normalised ratio (INR) of prothrombin time \\>1.3\n     * OR total serum bilirubin concentration ≥1.5x ULN\n2. Any history or evidence of acute or chronic liver disease other than MASH\n3. Histologically documented liver cirrhosis (fibrosis stage F4), either at screening or in a historical biopsy\n4. History of or current diagnosis of hepatocellular carcinoma\n5. History of or planned liver transplant\n6. Inability or unwillingness to undergo a liver biopsy at screening (if a suitable historical biopsy is unavailable for central review), or during trial conduct.\n7. History of portal hypertension or presence of decompensated liver disease\n8. Model for end-stage liver disease (MELD) score ≥12 due to liver disease. Further exclusion criteria apply","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II DBA Arizona Clinical Trials","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottsdale Medical Specialists, Ltd","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adobe Clinical Research, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Clinical Research","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Chula Vista","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARK Clinical Research","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fresno Clinical Research Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Gardena-69773","city":"Gardena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Huntington Park","city":"Huntington Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"310 Clinical Research","city":"Inglewood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, San Diego","city":"La Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research, LLC","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARK Clinical Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Westlake","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinnova Research Solutions","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fomat Medical Research","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Liver Research Institute","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cadena Care Institute, LLC","city":"Poway","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ficramed Research Institute","city":"Poway","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Clinical Trials, LLC","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Clinical Trials","city":"San Bernardino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Acclaim Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Associates Research Group, Inc.","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Santa Ana","city":"Santa Ana","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Van Nuys","city":"Van Nuys","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research, LLC","city":"Victorville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Future Innovative Treatments","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Denver Gastroenterology PC","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Connecticut Gastroenterology Clinical Research Foundation","city":"Bristol","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OMEGA Research Group","city":"Altamonte Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare of Tampa","city":"Brandon","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Access research Institute","city":"Brooksville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa Bay Medical Research","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Winter Garden","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hi Tech and Global Research, LLC","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cenara Clinical Research","city":"Cutler Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Covenant Metabolic Specialists, LLC - Fort Myers","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Neoclinical Research","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evolution Clinical Trials","city":"Hialeah Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Global Research Associates","city":"Homestead","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lake Center for Clinical Research","city":"Lady Lake","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida 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3: Survodutide for Metabolic Dysfunction Associated Steatohepatitis (MASH)","inPlainEnglish":"This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study. this study wants to find out whether a medicine called survodutide helps people with MASH and moderate or advanced liver fibrosis improve their liver function.","whoItsFor":["Ages 18 Years to any","Male or female participants ≥18 years (or who are of legal age in countries where that is greater than 18 years) of age at time of consent","Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD)) activity score \\[NAS\\] ≥4","Stable body weight defined as less than 5% self-reported change in body weight 3 months prior to the screening or during the period between the historical biopsy and randomisation, if a historical biopsy is used","Be willing to maintain a stable diet and physical activity levels throughout the entire trial Further who can join apply"],"whoShouldSkip":["Any of the following liver laboratory test abnormalities at screening:","Serum AST and/or alanine aminotransferase (ALT) elevation ≥5x upper limit of normal (ULN)","Platelet count \\<140 000/mm\\^3 (\\<140 GI/L)","Alkaline phosphatase \\>2x upper limit of normal (ULN)","Abnormal synthetic liver function as defined by screening central laboratory evaluation:","Albumin below \\<3.5 g/dL (35.0 g/L)","OR International normalised ratio (INR) of prothrombin time \\>1.3"],"whatHappens":"If you join, the listed intervention(s) are Survodutide, or Placebo. The registry lists allocation as randomized. This study is open to adults who are at least 18 years old living with obesity and have: * a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and * moderate or advanced liver fibrosis People with a history of acute or chronic liver diseases other than MASH or chronic alcohol intake cannot take part in this study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,800 people at 532 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.151Z"},{"nctId":"NCT06632457","title":"LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis","officialTitle":"A Phase III Double-blind, Randomised, Placebo-controlled Trial to Evaluate Liver-related Clinical Outcomes and Safety of Once Weekly Injected Survodutide in Participants With Compensated Non-alcoholic Steatohepatitis/Metabolic Dysfunction Associated Steatohepatitis (NASH/MASH) Cirrhosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults who are at least 18 years old and have:\n\n* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or\n* A confirmed liver disease called metabolic-associated steatohepatitis (MASH)\n* BMI of 27 kg/m2 or more or\n* 25 kg/m2 or more if the participant is Asian.\n\nPeople with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.\n\nParticipants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.\n\nParticipants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.\n\nThe doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.","conditions":["Metabolic Dysfunction Associated Steatohepatitis"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Survodutide"},{"type":"COMBINATION_PRODUCT","name":"Placebo matching survodutide"}],"enrollment":1590,"startDate":"2024-11-12","completionDate":"2029-06-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Male or female adults ≥18 years of age at the time of screening, and at least the legal age of consent in countries where it is \\>18 years\n2. Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)\n3. Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.\n4. Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF \\<5% or FibroScan® with CAP \\<288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.\n5. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Current or history (\\<5 years) of significant alcohol consumption, defined as an average of \\>140 g/week in female patients and \\>210 g/week in male patients, for a period of \\>3 consecutive months, or an inability to reliably quantify alcohol consumption based upon judgment of the investigator.\n2. Model of end-stage liver Disease (MELD) score \\>12 due to liver disease\n3. History or current (i.e. at screening) hepatic decompensation event of any of the following but not limited to:\n\n   * Portal hypertension-related upper gastrointestinal (GI) bleeding\n   * Ascites\n   * Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria\n4. Any of the following lab test result at screening\n\n   * Albumin below \\<3.5 g/dL (\\<35.0 g/L)\n   * International normalised ratio (INR) \\>1.3 unless due to therapeutic anticoagulants\n   * Total bilirubin (TBL) \\>1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL \\>1.2x ULN if reticulocyte count is within normal limits, haemoglobin is within normal limits unless due to chronic anaemia and unrelated to haemolysis, and direct bilirubin is \\<20% of TBL.\n   * Alkaline phosphatase \\>1.5x ULN\n   * PLT \\<100,000/µL (\\<100 GI/L)\n5. History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis\n6. Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection\n7. Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))\n8. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\>5x ULN\n9. Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history\n10. History of liver transplantation or listed for liver transplantation\n11. History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment\n12. Further exclusion criteria apply","locations":[{"facility":"The Institute for Liver Health II DBA Arizona Clinical Trials","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottsdale Medical Specialists, Ltd","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adobe Clinical Research, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Clinical Research","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Chula Vista","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARK Clinical Research","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research-Huntington Park","city":"Huntington Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"310 Clinical Research","city":"Inglewood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, San Diego","city":"La Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research, LLC","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinnova Research Solutions","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fomat Medical Research","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cadena Care Institute, LLC","city":"Poway","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ficramed Research Institute","city":"Poway","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Clinical Trials, LLC","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Clinical Trials","city":"San Bernardino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Acclaim Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Future Innovative Treatments","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Denver Gastroenterology PC","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Connecticut Gastroenterology Clinical Research Foundation","city":"Bristol","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare of Tampa","city":"Brandon","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Access research Institute","city":"Brooksville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hi Tech and Global Research, LLC","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cenara Clinical Research","city":"Cutler Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Covenant Metabolic Specialists, LLC - 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The registry lists allocation as randomized. This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * body-mass index (BMI) of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,590 people at 447 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.149Z"},{"nctId":"NCT06635148","title":"A Long-term Extension Study of JNJ-81201887 (AAVCAGsCD59) Parent Studies in Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)","officialTitle":"Long-term Extension Study for Participants With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD) in JNJ-81201887 Parent Clinical Studies","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.","conditions":["Geographic Atrophy","Macular Degeneration"],"keywords":[],"interventions":[{"type":"DRUG","name":"JNJ-81201887"},{"type":"OTHER","name":"Sham Procedure"}],"enrollment":274,"startDate":"2024-09-19","completionDate":"2029-08-24","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who were enrolled and received treatment with JNJ-81201887 or sham in a parent clinical study (81201887MDG2001, 81201887MDG1003)\n* Females (women of childbearing potential), male participants, and partners of male participants will not be required to use contraception in this LTE study\n* Must sign an informed consent form (ICF) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. 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The registry lists allocation as randomized. This study wants to assess the long-term whether it is safe and how hard side effects are to live with after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 274 people at 104 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.143Z"},{"nctId":"NCT06636786","title":"Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","officialTitle":"Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) - (Optimizing Acute Stress Reaction Interventions With TNX-102 SL - OASIS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of North Carolina, Chapel Hill","sponsorClass":"OTHER","summary":"This study will examine the safety and efficacy of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a double-blind placebo-controlled randomized clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term. 180 participants will be randomized, receive study drug in ED and be discharged with a 2-week drug supply. Prior to initial dose of study drug administration, and during the hours, days, and weeks after participants will receive serial longitudinal assessments of psychological and somatic symptoms, neurocognitive function, and adverse events.","conditions":["Acute Stress Reaction","Acute Stress Disorder","Neurocognitive Function","Post-traumatic Stress"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cyclobenzaprine HCl"},{"type":"DRUG","name":"Placebo"}],"enrollment":180,"startDate":"2025-03-25","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ≥ 18 years and ≤ 55 years of age\n2. Presentation to ED and able to complete enrollment visit activities within 72 hours of MVC\n3. Anticipated to be discharged home from the ED\n4. Stated willingness to comply with all study procedures and availability for the duration of the study\n5. Consent to receive unencrypted communications\n6. Has a smartphone with continuous service for ≥ 1 year\n7. Has a personal email address they regularly access\n8. Able to speak and read English\n9. Pain severity in the ED ≥ 4 (0-10 numeric rating scale)\n10. People who are not of childbearing potential (e.g., hysterectomy, bilateral oophorectomy, or confirmed postmenopausal for at least last 12 consecutive months)\n11. People with the capacity to conceive a pregnancy must agree to employ a highly effective form of birth control throughout the first 28 days of study participation (e.g., oral, injected, transdermal, or implanted hormonal methods of contraception for at least one full menstrual cycle prior to study drug administration; placement of an intrauterine device (IUD) or intrauterine system (IUS); or double barrier methods such as condoms and diaphragms)\n\nExclusion Criteria:\n\n1. Substantial comorbid injury (e.g., long bone fracture)\n2. People of childbearing potential who are pregnant, breastfeeding, planning to become pregnant, or not using a highly effective form of contraception (e.g., implants, intrauterine devices (IUDs), tubal ligation, hormonal birth control pills, patches, vaginal rings, or injections) during their participation\n3. Prisoner status\n4. Any chronic daily opioid use prior to MVC\n5. Active psychosis, suicidal ideation, or homicidal ideation\n6. Plans for hospital admission\n7. History of arrhythmias, heart block or conduction disturbances, congestive heart failure\n8. Currently in the acute recovery phase of myocardial infarction\n9. Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or placebo formulations\n10. History of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism (TSH \\< lower limit of normal)\n11. Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation due to risk of potential fatal drug-drug interactions\n12. Current or planned use of the following prohibited concomitant medications during study participation: anticholinergic medications, guanethidine, selective serotonin reuptake inhibitors (SSRIs) , serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, MAO inhibitors, anticholinergic medications, guanethidine, potent cytochrome P450 subtype 3A4 inhibitor, St. John's wort, chronic use muscle relaxants or planned use after MCV or other prohibited concomitant medications listed in section 5.6. PI to assess individual cases where single dose of muscle relaxant is prescribed in ED for inclusion\n13. Any hepatic impairment or renal disease (defined as AST OR ALT \\> 3 times the upper limit of normal) or renal disease (defined as GFR ≤ 80 mL/min)\n14. In addition to the lab results in exclusion #13 above, exclude patients who report the following and or if the following are in medical records -\n\n    * history of renal disease\n    * history of urinary retention, angle-closure glaucoma, increased intraocular pressure, or hyperthyroidism\n15. As part of additional screening, exclude patients who answer yes to any of the questions listed below-\n\n    * Have you ever been told that you have renal or kidney disease?\n    * Have you ever been diagnosed with hyperthyroidism or active overactive thyroid?\n    * Have ever been told that you have a liver disease or cirrhosis, or problems with your liver?\n16. Any history of seizure disorder\n17. Lacking capacity to provide informed consent (receipt of sedative, hypnotic agent making the patient non-decisional for consent)\n18. Any other history or condition that would, in the site investigator's judgement, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger patient)\n19. Elevated baseline blood pressure defined as systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mmHg and or elevated heart rate of ≥115\n20. Abnormal baseline ECG as defined as: QRS duration ≥ 120 ms; QTc \\> 460 ms; not in sinus rhythm; or 1st, 2nd, or 3rd degree heart block indicated\n21. Substance or alcohol use disorder, bipolar disorder, or schizophrenia\n22. History of severe or unexplained oral, or oropharyngeal swelling or edema\n23. History of presyncope or syncopal episodes","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cooper University Health System","city":"Camden","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rhode Island Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Miriam Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Romina Soudavari","phone":"9843195030","email":"romina_soudavari@med.unc.edu"}],"primaryOutcomes":["Change in ASD Score"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","indianapolis-indiana","kansas-city-kansas","st-louis-missouri","camden-new-jersey","columbus-ohio","providence-rhode-island","san-antonio-texas"],"enrichment":{"headline":"Phase 2: testing Cyclobenzaprine HCl for Acute Stress Reaction","inPlainEnglish":"This study will examine the safety and how well it works of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC). Specifically, the investigators will perform the Optimizing Acute Stress reaction Interventions with TNX-102 SL (OASIS) Trial, a neither you nor the study doctors know who gets the real treatment compared with a dummy treatment randomly assigned clinical trial (RCT) to determine if TNX-102 SL initiated in the ED in the hours after MVC to high risk individuals, treats/reduces acute stress reaction (ASR)/acute stress disorder (ASD) symptoms (primary outcome), improves neurocognitive function, and prevents/reduces posttraumatic stress (PTS) symptoms (secondary outcomes) long term.","whoItsFor":["Ages 18 Years to 55 Years","≥ 18 years and ≤ 55 years of age","Presentation to ED and able to complete enrollment visit activities within 72 hours of MVC","Anticipated to be discharged home from the ED","Stated willingness to comply with all study procedures and availability for the duration of the study","Consent to receive unencrypted communications","Has a smartphone with continuous service for ≥ 1 year","Has a personal email address they regularly access"],"whoShouldSkip":["Substantial comorbid injury (e.g., long bone fracture)","Any chronic daily opioid use prior to MVC","Active psychosis, suicidal ideation, or homicidal ideation","Plans for hospital admission","History of arrhythmias, heart block or conduction disturbances, congestive heart failure","Currently in the acute recovery phase of myocardial infarction","Hypersensitivity to cyclobenzaprine or the excipient in TNX-102 SL or dummy treatment (placebo) formulations"],"whatHappens":"If you join, the listed intervention(s) are Cyclobenzaprine HCl, or Placebo. The registry lists allocation as randomized. This study will examine the safety and how well it works of TNX-102 SL to reduce ASR symptoms and behavioral changes among patients presenting to the emergency department (ED) after motor vehicle collision (MVC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.414Z"},{"nctId":"NCT06639464","title":"Semaglutide for Helping Opioid Recovery","officialTitle":"Semaglutide for the Treatment of Opioid Use Disorder: A Pilot Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Brigham and Women's Hospital","sponsorClass":"OTHER","summary":"The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD.","conditions":["Opioid Use Disorder"],"keywords":["semaglutide","opioid use disorder","buprenorphine"],"interventions":[{"type":"DRUG","name":"Semaglutide"},{"type":"OTHER","name":"Placebo"}],"enrollment":46,"startDate":"2025-06-02","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* English-speaking adults aged 18 or older\n* DSM-5 diagnosis of severe opioid use disorder (OUD)\n* Receiving buprenorphine ≥16 mg/day or methadone ≥70 mg/day for at least 30 days prior to enrollment\n* Planning to continue buprenorphine or methadone treatment throughout the study\n* Willing to bring buprenorphine prescriptions to visits for dose counts (if applicable)\n* Willing to authorize communication between the study team and their MOUD prescriber via a 42 CFR release\n\nExclusion Criteria\n\n* Active psychosis, suicidality, homicidality, or psychiatric conditions impairing capacity to consent\n* Current or lifetime history of an eating disorder\n* BMI \\<21 kg/m²\n* Current or lifetime diagnosis of Type 1 or Type 2 diabetes\n* Personal or family history of medullary thyroid carcinoma or MEN2\n* GLP-1 receptor agonist use within the past 3 months or anticipated use during the study\n* Myocardial infarction, stroke, unstable angina, or congestive heart failure within the past 90 days\n* Persistently elevated BP (\\>160 mmHg systolic or \\>100 mmHg diastolic) during screening\n* History of inflammatory bowel disease, bariatric surgery, idiopathic pancreatitis, or diabetic gastroparesis\n* Liver function tests \\>3x the upper limit of normal or eGFR \\<30\n* History of hypersensitivity or allergy to semaglutide\n* Pregnancy or breastfeeding\n* Anticipated participation in another investigational drug trial\n* Any other condition that investigators determine may interfere with participation or pose a safety concern","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joji Suzuki","phone":"617-732-5752","email":"jsuzuki2@bwh.harvard.edu"}],"primaryOutcomes":["Cue-induced Cravings for Opioids","Relapse to Illicit Opioid Use"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["semaglutide"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: testing Semaglutide for Opioid Use Disorder","inPlainEnglish":"The is a pilot, 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching dummy treatment (placebo) (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD.","whoItsFor":["Ages 18 Years to any","English-speaking adults aged 18 or older","DSM-5 diagnosis of severe opioid use disorder (OUD)","Receiving buprenorphine ≥16 mg/day or methadone ≥70 mg/day for at least 30 days prior to enrollment","Planning to continue buprenorphine or methadone treatment throughout the study","Willing to bring buprenorphine prescriptions to visits for dose counts (if applicable)","Willing to authorize communication between the study team and their MOUD prescriber via a 42 CFR release"],"whoShouldSkip":["Active psychosis, suicidality, homicidality, or psychiatric conditions impairing capacity to consent","Current or lifetime history of an eating disorder","Current or lifetime diagnosis of Type 1 or Type 2 diabetes","Personal or family history of medullary thyroid carcinoma or MEN2","GLP-1 receptor agonist use within the past 3 months or anticipated use during the study","Myocardial infarction, stroke, unstable angina, or congestive heart failure within the past 90 days","Persistently elevated BP (\\>160 mmHg systolic or \\>100 mmHg diastolic) during screening"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide, or Placebo. The registry lists allocation as randomized. The is a pilot, 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching dummy treatment (placebo) (n=23).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 46 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.735Z"},{"nctId":"NCT06641908","title":"Anti-GD2 ADC M3554 in Advanced Solid Tumors","officialTitle":"A Phase 1, Two-Part, Multicenter, Open-Label First in Human Study of Anti-GD2 Antibody Drug Conjugate M3554 in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"EMD Serono Research & Development Institute, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to establish the recommended doses and further evaluate the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.\n\nStudy details include:\n\nStudy Duration per participant: Approximately 4 months","conditions":["Advanced Solid Tumor"],"keywords":["Glioblastoma","IDH-wildtype","Soft tissue sarcomas","GD2 prevalence","targeted therapy","TOP1 inhibitor","exatecan"],"interventions":[{"type":"DRUG","name":"M3554"}],"enrollment":65,"startDate":"2024-11-08","completionDate":"2027-04-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting.\n* Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention.\n* Escalation B: participants with documented histopathological diagnosis of glioblastoma, IDH-wildtype, who have progressed after ONLY one prior line of therapy (including radiotherapy +/- temozolomide, depending on the O\\^6-methylguanine-DNA methyltransferase \\[MGMT\\] status) and relapsing at least 3 months after the end of the radiotherapy treatment.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1\n* Participants with adequate hematologic, hepatic and renal function as defined in protocol\n* Other protocol defined inclusion criteria could apply\n\n  * Exclusion Criteria:\n* Participant has a history of malignancy other than STS or glioblastoma (depending on the escalation/expansion cohort) within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, is considered cured with minimal risk of recurrence within 3 years).\n* STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression\n* Other protocol defined exclusion criteria could apply.","locations":[{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan-Kettering Cancer Center (MSKCC) - New York - Memorial Sloan Kettering Cancer Center (CC)- Westc","city":"New York","state":"New York","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Bergonié - Service d'Oncologie Médicale","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret - cancerologie generale","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Leon Berard - Service d'Oncologie Medicale","city":"Lyon","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre Antoine Lacassagne - Service d'Hématologie Oncologie","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsspital Zuerich - Klinik fuer Neurologie","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital-Sutton - Dept of Oncology (Surrey)","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US Medical Information","phone":"888-275-7376","email":"eMediUSA@emdserono.com"},{"name":"Communication Center","phone":"+49 6151 72 5200","email":"service@emdgroup.com"}],"primaryOutcomes":["Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["boston-massachusetts","new-york-new-york","houston-texas","leuven-belgium","bordeaux-france","lille-france","lyon-france","nice-france","ch-ku-japan","zurich-switzerland","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing M3554 for Advanced Solid Tumor","inPlainEnglish":"This study wants to establish the recommended doses and further measure the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype. Study details include: Study Duration per participant: Approximately 4 months","whoItsFor":["Ages 18 Years to any","Escalation A: participants with documented histopathological diagnosis of locally advanced or metastatic STS with unresectable disease that has progressed after at least one prior line of anthracycline-containing systemic therapy for the locally advanced/metastatic setting","Participants with resectable locally advanced or metastatic disease, who had surgery before study entry will be allowed in the trial if there is residual disease after surgery and if the surgery was performed at least 4 weeks before first dose of study intervention","Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1","Participants with adequate hematologic, hepatic and renal function as defined in protocol","Other protocol defined who can join could apply"],"whoShouldSkip":["STS only: Participants with history of brain metastasis, leptomeningeal metastasis, or participants with spinal cord compression","Other protocol defined"],"whatHappens":"If you join, the listed intervention(s) are M3554. The registry lists allocation as na. This study wants to establish the recommended doses and further measure the safety and preliminary antitumor activity of M3554 in participants with soft tissue sarcoma (STS) and glioblastoma, IDH-wildtype.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 65 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.475Z"},{"nctId":"NCT06642272","title":"A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record","officialTitle":"A Pragmatic Trial Comparing Empagliflozin and Dapagliflozin Through Cluster Randomization Embedded in the Electronic Health Record","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Herlev and Gentofte Hospital","sponsorClass":"OTHER","summary":"The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure.\n\nPatients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study. Treatment will be randomized automatically through the electronic health record software in clusters defined by time of day.\n\nhttps://www.appletreestudy.com","conditions":["Diabetes Mellitus, Type 2","Heart Failure","Chronic Kidney Diseases"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"},{"type":"DRUG","name":"Dapagliflozin 10 MG"}],"enrollment":17200,"startDate":"2024-10-10","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or more\n\nExclusion Criteria:\n\n* Incapabability of giving informed consent\n* Withdrawal of informed consent","locations":[{"facility":"Bispebjerg Hospital","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herlev and Gentofte Hospital","city":"Herlev","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Steno Diabetes Center Copenhagen","city":"Herlev","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nordsjællands Hospital","city":"Hillerød","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holbæk Sygehus","city":"Holbæk","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hvidovre Hospital","city":"Hvidovre","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sjællands Universitetshospital","city":"Køge","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nykøbing F. Sygehus","city":"Nykøbing Falster","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sjællands Universitetshospital","city":"Roskilde","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bornholms Hospital","city":"Rønne","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Slagelse Sygehus","city":"Slagelse","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Morten Schou, Professor","phone":"004540523920","email":"morten.schou.04@regionh.dk"},{"name":"Daniel M. Christensen, MD, PhD","phone":"004526248546","email":"dmc@dadlnet.dk"}],"primaryOutcomes":["Time to the first occurrence of any of the components of the composite: all-cause mortality, hospitalization for heart failure, hospitalization for myocardial infarction, hospitalization for ischemic stroke, and incident or worsening nephropathy."],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","heart-failure"],"drugSlugs":["empagliflozin","dapagliflozin"],"locationSlugs":["copenhagen-denmark","herlev-denmark","hiller-d-denmark","holb-k-denmark","hvidovre-denmark","k-ge-denmark","nyk-bing-falster-denmark","roskilde-denmark","r-nne-denmark","slagelse-denmark"],"enrichment":{"headline":"Phase 4: testing Empagliflozin 10 MG for Diabetes Mellitus, Type 2","inPlainEnglish":"The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure. Patients who are prescribed either empagliflozin or dapagliflozin, as part of daily clinical practice at the participating sites, will be included in the study.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or more"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG, or Dapagliflozin 10 MG. The registry lists allocation as randomized. The aim of this clinical trial is investigate the comparative effectiveness of empagliflozin and dapagliflozin for the treatment of diabetes, chronic kidney disease, and heart failure.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 17,200 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.616Z"},{"nctId":"NCT06645236","title":"DHF-20-1839-2: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit","officialTitle":"Interventional IVD Study Testing DNA From Tumor Tissue Biopsies From mCRC Patients to Determine KRAS G12C Mutation Status for the Inclusion in the Amgen Clinical Trial, 20210081 for the Clinical Performance of Therascreen® KRAS RGQ PCR Kit","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"QIAGEN Gaithersburg, Inc","sponsorClass":"INDUSTRY","summary":"To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.","conditions":["Metastatic Colorectal Cancer (mCRC)"],"keywords":["Metastatic Colorectal Cancer","therascreen","KRAS G12C","sotorasib","Clinical Performance Study","Companion Diagnostic"],"interventions":[{"type":"DEVICE","name":"therascreen® KRAS RGQ PCR Kit"}],"enrollment":600,"startDate":"2023-12-22","completionDate":"2030-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study.\n\nExclusion Criteria:\n\n* There is no separate inclusion and exclusion criteria for the performance study.","locations":[{"facility":"QIAGEN Gaithersburg, Inc","city":"Manchester","state":"Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Johnson, Dr.","phone":"0044 07825866041","email":"sarah.johnson@qiagen.com"},{"name":"Parul Choudhary","phone":"","email":"Parul.Choudhary@qiagen.com"}],"primaryOutcomes":["Detection of KRAS G12C mutation status","Progression Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":["sotorasib"],"locationSlugs":["manchester-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: therascreen® KRAS RGQ PCR Kit for Metastatic Colorectal Cancer (mCRC)","inPlainEnglish":"To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial. Results of the Phase 3 Amgen Study 20210081 will serve as the basis for establishing the clinical performance of the therascreen® KRAS RGQ PCR Kit as a companion diagnostic (CDx) for the identification of patients with metastatic colorectal cancer, who may benefit from treatment with sotorasib.","whoItsFor":["Ages 18 Years to any","Subjects who consent to participate in the eligibility screen for Protocol 20210081 will have their tumor tissue tested for the presence of KRAS G12C mutation under the proposed performance study"],"whoShouldSkip":["There is no separate inclusion and"],"whatHappens":"If you join, the listed intervention(s) are therascreen® KRAS RGQ PCR Kit. The registry lists allocation as na. To utilize the therascreen KRAS RGQ PCR Kit, as a screening test in Amgen's Phase 3 Clinical Study Protocol 20210081, in order to identify patients with mCRC KRAS G12C mutation positive tumors to be enrolled in the drug clinical trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 600 people at Manchester. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.974Z"},{"nctId":"NCT06646276","title":"A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","officialTitle":"A Randomized, Double Blind, Multicenter Phase 3 Trial of BMS-986489 (Atigotatug+Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide vs Atezolizumab in Combination With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The Purpose of the Study is to Compare the Efficacy and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.","conditions":["Extensive-Stage Small Cell Lung 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0295","city":"Seville","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0248","city":"Chur","state":"","country":"Switzerland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0249","city":"Winterthur","state":"","country":"Switzerland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0247","city":"Zurich","state":"","country":"Switzerland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0158","city":"Çiğli","state":"İzmir","country":"Turkey (Türkiye)","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0154","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0157","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0177","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0153","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0183","city":"Central Middlesbrough","state":"Middlesbrough","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0159","city":"Aberdeen","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0101","city":"Manchester","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0226","city":"Metropolitan Borough of Wirral","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["daphne-alabama","hot-springs-arkansas","fort-myers-florida","orange-city-florida","st-petersburg-florida","marietta-georgia","peoria-illinois","minneapolis-minnesota","albuquerque-new-mexico","durham-north-carolina","bismarck-north-dakota","fargo-north-dakota","cincinnati-ohio","sioux-falls-south-dakota","nashville-tennessee","austin-texas","tyler-texas","roanoke-virginia","edmonds-washington","seattle-washington","ciudad-aut-noma-de-buenos-aires-argentina","abb-argentina","buenos-aires-argentina","caba-argentina","r-o-cuarto-argentina","campbelltown-australia","penrith-australia","brisbane-australia","ballarat-central-australia","murdoch-australia","graz-austria","wels-austria","linz-austria","rankweil-austria","brussels-belgium","ghent-belgium","sint-niklaas-belgium","li-ge-belgium","fortaleza-brazil","porto-alegre-brazil","santa-cruz-do-sul-brazil","itaja-brazil","barretos-brazil","s-o-paulo-brazil","edmonton-canada","chicoutimi-canada","qu-bec-canada","rimouski-canada","santiago-chile","vi-a-del-mar-chile","beijing-china","chongqing-china","fuzhou-china","xiamen-china","shantou-china","harbin-china","wuhan-china","changsha-china","nanchang-china","changchun-china","shenyang-china","xian-china","jinan-china","shanghai-china","chengdu-china","tianjin-china","hangzhou-china","linhai-china","brno-czechia","ostrava-czechia","prague-czechia","olomouc-czechia","montpellier-france","la-tronche-france","lille-france","gleiz-france","pierre-b-nite-france","cr-teil-france","villejuif-france","marseille-france","paris-france","quimper-france","frankfurt-am-main-germany","oldenburg-germany","cologne-germany","halle-germany","bad-berka-germany","gauting-germany","gro-hansdorf-germany","heidelberg-germany","stuttgart-germany","athens-greece","thessaloniki-greece","larissa-greece","bengaluru-india","new-delhi-india","madurai-india","varanasi-india","kolkata-india","naples-italy","milan-italy","rome-italy","perugia-italy","peschiera-del-garda-italy","bologna-italy","matsuyama-japan","kurume-japan","sapporo-japan","kobe-japan","kanazawa-japan","yokohama-japan","sendai-japan","kashihara-japan","kurashiki-japan","hirakata-japan","saka-sayama-japan","takatsuki-japan","hidaka-japan","ina-machi-japan","hamamatsu-japan","bunkyo-ku-japan","koto-japan","fukushima-japan","kuala-lumpur-malaysia","kuching-malaysia","guadalajara-mexico","puebla-city-mexico","amsterdam-netherlands","arnhem-netherlands","groningen-netherlands","konin-poland","poznan-poland","prabuty-poland","bydgoszcz-poland","lodz-poland","bucharest-romania","flore-ti-romania","craiova-romania","cluj-napoca-romania","ia-i-romania","cheongju-si-south-korea","seongnam-south-korea","suwon-south-korea","seoul-south-korea","daegu-south-korea","santiago-de-compostela-spain","barcelona-spain","ja-n-spain","madrid-spain","majadahonda-spain","valencia-spain","seville-spain","chur-switzerland","winterthur-switzerland","zurich-switzerland","i-li-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","central-middlesbrough-united-kingdom","aberdeen-united-kingdom","manchester-united-kingdom","metropolitan-borough-of-wirral-united-kingdom"],"enrichment":{"headline":"Phase 3: testing BMS-986489 (Atigotatug+Nivolumab) for Extensive-Stage Small Cell Lung Cancer","inPlainEnglish":"The Purpose of the Study is to Compare the how well it works and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.","whoItsFor":["Ages 18 Years to any","Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale","Participants must have at least one tumor that can be measured using special imaging techniques like a CT scan or MRI at a site other than the brain and nervous system"],"whoShouldSkip":["Participants have already received certain types of treatment for extensive stage small cell lung cancer","Participants have certain health conditions, like spread of small cell lung cancer to the brain that are causing symptoms, certain lung diseases, heart diseases, infections, autoimmune diseases, other cancers, or a type of nerve damage called peripheral sensory neuropathy","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are BMS-986489 (Atigotatug+Nivolumab), Atezolizumab, or Carboplatin. The registry lists allocation as randomized. The Purpose of the Study is to Compare the how well it works and Safety of BMS-986489 (Anti-fucosyl-GM1+ Nivolumab Fixed Dose Combination) in Combination with Carboplatin plus Etoposide to that of Atezolizumab with Carboplatin plus Etoposide as First-Line Therapy in Participants with Extensive-Stage Small Cell Lung Cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 530 people at 183 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.725Z"},{"nctId":"NCT06647069","title":"A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases","officialTitle":"A Phase 1, Open-label, Multiple Ascending Dose Basket Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Select Autoimmune Rheumatic Diseases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201.\n\nThe study duration per participant will be a minimum of approximately 13 months, including a screening period of up to 28 days, a treatment period of 71 days, and a follow-up period of 42 weeks. If necessary, participants will continue to have visits after End of Study (EOS) every 4 weeks until peripheral blood B cells return to at least 80% of either the lower limit of normal (LLN) or the participant's baseline value.","conditions":["Systemic Lupus Erythematosus (SLE)","Rheumatoid Arthritis (RA)"],"keywords":[],"interventions":[{"type":"DRUG","name":"SAR448501"}],"enrollment":62,"startDate":"2025-03-27","completionDate":"2029-06-25","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of SLE and/or RA. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria should be used.\n* Contraception during the study intervention period and for at least 140 days after the last administration of study intervention: Male participants must agree to refrain from donating or cryopreserving sperm, and either be abstinent or use contraception/barrier. Female participants must use of a highly effective contraceptive measure for all females of childbearing potential. Females of childbearing potential need to have a negative serum pregnancy test within 7 days prior to the first dose.\n* Specific to Systemic Lupus Erythematosus (SLE):\n\n  * Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening.\n  * At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening\n  * Positive ANA (titer ≥1:80) as documented in the participant's medical history\n  * Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies\n  * Inadequate response to systemic glucocorticoids and to at least 1 therapy other than antimalarials for at least 12 weeks including: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin.\n* Specific to Rheumatoid Arthritis (RA):\n\n  \\-- Moderate-to-severe disease activity as defined by a 28-joint disease activity score using C reactive protein (DAS28-CRP) \\>3.2 at screening.\n* Inadequate response or intolerance to at least 2 disease-modifying antirheumatic drugs (DMARDs, at least 1 biologic \\[bDMARD\\] or targeted synthetic \\[tsDMARD\\]) after a minimum of 12 weeks treatment duration.\n* At least 6 tender joints at screening.\n* At least 6 swollen joints at screening.\n* Methotrexate (MTX) for at least 12 consecutive weeks, and at a stable dose of ≤25 mg/week oral or SC since at least 4 weeks prior to randomization, OR - in case of MTX intolerance - conventional DMARDs at a stable dose for at least 28 days.\n* If taking MTX, compliant with folic acid 1 mg daily or 5 mg weekly or greater in combination with MTX.\n\nExclusion Criteria:\n\n* Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD.\n* Receipt of super-high potency (eg, clobetasol propionate, betamethasone dipropionate) or high potency (eg, fluocinonide, methylprednisolone aceponate) topical corticosteroids within 28 days prior to screening, had dose changes in other topical corticosteroids within 14 days prior to Day 1, or had dose changes in nonsteroidal topical immunosuppressants within 28 days prior to Day 1.\n* Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1.\n* Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \\>20 mg/day, abatacept.\n* Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer.\n* Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1.\n* Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN.\n* Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy.\n* Known history of a primary immunodeficiency or an underlying condition such as known human immunodeficiency virus (HIV) infection, positive result for HIV infection, splenectomy, or any underlying condition that predisposes the participant to infection.\n* History of a hypersensitivity reaction or anaphylaxis to a previous mAb or human immunoglobulin therapy.\n* Active infection or a history of serious infections as defined in the protocol.\n* Surgery within 28 days prior to Day 1.\n* 12-lead ECG parameters after 10 minutes resting in supine position NOT in the defined normal ranges.\n* Evidence of significant, uncontrolled concurrent disease that could affect compliance with the study (eg, chronic obstructive pulmonary disease).\n* Diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected or cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline.\n* High dose of antimalarial or a change in dose within 28 days prior to Day 1.\n* Receipt of systemic corticosteroids \\>20 mg/day (prednisone or equivalent) or had dose changes of systemic corticosteroids within 28 days prior to Day 1.\n* Documented liver disease including documented diagnosis of cirrhosis.\n* Participants with a history of hypercoagulation event or thrombosis (such as venous thromboembolism, pulmonary embolism, or stroke), or participants who have known hypercoagulation risk factors (including antiphospholipid syndrome), or participants currently on anticoagulation will be excluded.\n* Specific to SLE:\n\n  * Active severe or unstable neuropsychiatric SLE including but not limited to seizures, psychosis, acute confusional state, transverse myelitis, central nervous system vasculitis and optic neuritis at screening.\n  * Known biopsy-proven diagnosis of lupus nephritis (any class) or otherwise unexplained proteinuria (0.5g protein/24h; or urine protein/creatinine ratio \\>0.5g/g) at screening.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number : 001-201","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 001-401","city":"Sarajevo","state":"","country":"Bosnia and Herzegovina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 268-003","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 268-001","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 001-301","city":"Auckland","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 001-801","city":"Pretoria","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 001-803","city":"Pretoria","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 001-804","city":"Vereeniging","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Incidence of treatment-emergent adverse events (TEAEs)","Incidence of potentially clinically significant abnormalities (PCSAs)"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["melbourne-australia","sarajevo-bosnia-and-herzegovina","tbilisi-georgia","auckland-new-zealand","pretoria-south-africa","vereeniging-south-africa"],"enrichment":{"headline":"Phase 1: testing SAR448501 for Systemic Lupus Erythematosus (SLE)","inPlainEnglish":"This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The purpose of the study is to identify possible optimal dose(s) by assessing the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary clinical response of SAR448501/DR-0201.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of SLE and/or RA. American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria should be used","Specific to Systemic Lupus Erythematosus (SLE):","Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score ≥8 at screening with at least 4 points from clinical features at screening","At least 1 British Isles Lupus Assessment (BILAG) A score or 1 BILAG B score at screening","Positive ANA (titer ≥1:80) as documented in the participant's medical history","Positive for any of the following as documented in the participant's medical history: antidsDNA, anti-Ro (anti-SS-A), anti-La (anti-SS-B), or anti-Sm antibodies","Specific to Rheumatoid Arthritis (RA):"],"whoShouldSkip":["Severe manifestation of the selected autoimmune rheumatic diseases under study that could impact participant safety, or is likely to require interventions that will affect investigational drug PD","Received dose changes of mycophenolate mofetil, methotrexate, leflunomide, calcineurin inhibitors, JAK inhibitors, or azathioprine within 28 days prior to Day 1","Receipt of any of the following medications within 6 months of Day 1: cyclophosphamide, leflunomide \\>20 mg/day, abatacept","Receipt of any mAb or experimental immunomodulator within 28 days or 5 published half-lives prior to Day 1, whichever is longer","Receipt of rituximab or other B cell depleting biologics within 6 months of Day 1","Receipt of rituximab or other B cell depleting biologics without return of CD19 or CD20 count to above the LLN","Receipt of alemtuzumab, bone marrow transplantation, stem cell transplantation, total lymphoid irradiation, CAR-T or T cell vaccination therapy"],"whatHappens":"If you join, the listed intervention(s) are SAR448501. The registry lists allocation as randomized. This is an open-label, multi-ascending dose (MAD) phase 1 study, with dose expansion at selected doses, in adult patients with select autoimmune rheumatic diseases including systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 62 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.964Z"},{"nctId":"NCT06649812","title":"Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma","officialTitle":"A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements (HGBCL-DH-BCL2)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Ibrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Obinutuzumab, a monoclonal antibody, binds to a protein called CD20, which is found on B cells and some types of leukemia and lymphoma cells. Obinutuzumab may block CD20 and help the immune system kill cancer cells. Revlimid, a type of anti-angiogenesis agent and a type of immunomodulating agent, may help the immune system kill abnormal blood cells or cancer cells. It may also prevent the growth of new blood vessels that cancers need to grow. ViPOR may be an effective treatment option for patients with relapsed and/or refractory CD10 negative DLBCL and high-grade B-cell lymphoma with MYC and BCL2 rearrangements.","conditions":["High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified","Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type","Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements","Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified","Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Ibrutinib"},{"type":"DRUG","name":"Lenalidomide"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Obinutuzumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"DRUG","name":"Prednisone"},{"type":"DRUG","name":"Venetoclax"}],"enrollment":120,"startDate":"2025-10-07","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:\n\n  * Cohort 1: CD10-negative DLBCL, which includes:\n\n    * CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL)\n    * CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL)\n    * CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)\n    * CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)\n    * CD10-negative T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL) OR\n  * Cohort 2: CD10-positive or negative HGBCL with MYC and BCL2 rearrangements (with or without BCL6 rearrangement) (HGBCL-DH-BCL2)\n\n    * NOTE: The site principal investigator must review and verify the pathology report findings to ensure the patient is eligible and is assigned to the respective cohort at the time of registration\n* Patient must have relapsed and/or refractory disease after at least 1 prior anthracycline and anti-CD20 antibody-containing regimen\n* Patient must not have confirmed or suspected primary mediastinal large B-cell lymphoma (PMBL)\n* Patient must not be pregnant due to the potential harm to an unborn fetus with the treatment regimens being used.\n\n  * All patients of childbearing potential must have a serum or urine study with a sensitivity of at least 25 mIU/mL within 14 days prior to registration to rule out pregnancy and again within 24 hours prior to starting cycle 1 day 1 of treatment.\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients of childbearing potential must not expect to conceive children by abstaining from sexual intercourse or by using accepted and effective methods of contraception throughout the entire duration of protocol treatment, including during dose interruptions, and for 6 months after the last dose of protocol treatment. Male patients must not father children by abstaining from sexual intercourse or by using a condom during sexual contact with pregnant partners or partners of childbearing potential throughout the entire duration of protocol treatment, including dose interruptions, and for 6 months after the last dose of protocol treatment even if they have had a successful vasectomy\n* Male patients must agree to not donate semen or sperm during the entire duration of protocol treatment or for at least 28 days after the last dose of lenalidomide\n* Patient must agree to abstain from breastfeeding during the entire duration of protocol treatment and for at least 6 months after the last dose of protocol treatment\n* Patient must agree to abstain from donating blood during the entire duration of protocol treatment and for at least 28 days after the last dose of lenalidomide\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,000/mcL without requirement for granulocyte colony stimulating factor (G-CSF) support (obtained ≤ 7 days prior to registration)\n* Hemoglobin ≥ 8 g/dL (obtained ≤ 7 days prior to registration)\n* Platelets ≥ 75,000/mcL without requirement for platelet transfusion support (obtained ≤ 7 days prior to registration)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 3.0 x institutional ULN for patients with documented Gilberts syndrome) (obtained ≤ 7 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (obtained ≤ 7 days prior to registration)\n* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 30 mL/min/1.73 m\\^2 (estimated by Cockcroft-Gault method or measured) (obtained ≤ 7 days prior to registration)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patient must not have confirmed or suspected primary DLBCL of the central nervous system (CNS) (PCNSL)\n* Patients with history of secondary CNS lymphoma (SCNSL) are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patient must not have taken or require warfarin or other strong CYP3A inhibitors or inducers within 7 days prior to registration.\n\n  * NOTE: Antiplatelet agents, other anticoagulants aside from warfarin, as well as mild or moderate CYP3A inhibitors or inducers are permitted on study but should be used with caution\n* Patient must not have an uncontrolled intercurrent illness that would interfere with the safety or efficacy assessment of this protocol\n* Patient must not have evidence of an active infection at the time of registration\n* Patient must not have the following current or prior anti-cancer treatment:\n\n  * Any chemotherapy, targeted therapy, anti-cancer antibodies, antibody-drug conjugates, or bi-specific antibodies received within 2 weeks prior to registration\n\n    * NOTE: Short courses of corticosteroids or palliative external beam radiation therapy (XRT) prior to registration are permitted\n  * More than 3 prior lines of cytotoxic chemotherapy, excluding targeted therapy, anti-cancer antibodies, antibody-drug conjugates, bi-specific antibodies, and radio- or toxin-immunoconjugates\n\n    * NOTE: Cytoreductive chemotherapy followed by autologous stem cell transplant (ASCT) counts as 1 line of cytotoxic therapy. Similarly, cytoreductive chemotherapy (either pre-T-cell collection or as bridging therapy) followed by pre-conditioning therapy/chimeric antigen receptor T-cell (CAR-T) counts as 1 line of therapy, as long as no disease progression occurs between interventions. For both therapies, if progressive disease is documented between 2 distinct regimens, then they should be counted as 2 lines of cytotoxic chemotherapy\n  * Radio- or toxin-immunoconjugates within 10 weeks prior to registration\n  * Previous treatment with more than one of the following study agents: venetoclax (or another BCL2 inhibitor), ibrutinib (or another BTK inhibitor), or lenalidomide (or another immunomodulatory imide drug \\[IMiD\\])\n  * Prior autologous stem cell transplant (ASCT), chimeric antigen receptor T-cell (CAR-T) therapy, or allogeneic stem cell (or other organ) transplant within 3 months prior to registration\n  * Any evidence of active graft-versus-host disease or requirement for immunosuppressants within 28 days prior to registration\n\n    * NOTE: In addition, patient must have recovered (i.e., ≤ grade 1 or baseline) from all adverse events due to previously administered anti-cancer treatment, surgery, or procedure\n    * NOTE: Exceptions to this include events not considered to place the patient at unacceptable risk of participation in the opinion of the treating investigator (i.e., alopecia)\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patient must have adequate formalin fixed paraffin embedded (FFPE) tumor tissue specimen from the initial diagnostic biopsy or on-study repeat tumor tissue biopsy for molecular analysis\n\n  * NOTE: Excisional tumor biopsy is preferred. Core needle biopsies will be considered adequate if there is enough tissue for the mandatory molecular analysis. Submission of an entire FFPE tumor block is preferred, but if unavailable 10 x 10um FFPE scrolls may be submitted as an alternative. If adequate archived FFPE tumor tissue is unavailable, the patient must be willing to undergo research biopsy for molecular analysis\n* Patient must have measurable disease\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2","locations":[{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Derby Care Center","city":"Derby","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Guilford","city":"Guilford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Kishwaukee","city":"DeKalb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Delnor","city":"Geneva","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Glenview Outpatient Center","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Grayslake Outpatient Center","city":"Grayslake","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Lake Forest Hospital","city":"Lake Forest","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern Medicine Oak Brook","city":"Oak Brook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hospital East","city":"Shiloh","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Warrenville","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center - Crown Point","city":"Crown Point","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology LLC","city":"Dyer","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Mary Medical Center","city":"Hobart","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Catherine Hospital","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Community Hospital","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Diagnostic Center - Munster","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Center - Valparaiso","city":"Valparaiso","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Greeley Medical Center","city":"Ames","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McFarland Clinic - Ames","city":"Ames","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Ankeny Clinic","city":"Ankeny","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McFarland Clinic - Boone","city":"Boone","state":"Iowa","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Saint Anthony Regional Hospital","city":"Carroll","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates at Mercy Medical Center","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - West Des Moines Clinic","city":"Clive","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iowa Methodist Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Des Moines Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broadlawns Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Laurel Clinic","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McFarland Clinic - Trinity Cancer Center","city":"Fort Dodge","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Healthcare Mission Cancer and Blood - Fort Dodge","city":"Fort Dodge","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McFarland Clinic - Jefferson","city":"Jefferson","state":"Iowa","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"McFarland Clinic - Marshalltown","city":"Marshalltown","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - Waukee Clinic","city":"Waukee","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Medical Center Jefferson","city":"New Orleans","state":"Louisiana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Walter Reed National Military Medical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Francis Hospital and Medical Group","city":"Escanaba","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Schoolcraft Memorial Hospital","city":"Manistique","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Saint Joseph's Medical Center","city":"Brainerd","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health - Deer River Clinic","city":"Deer River","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Cancer Center","city":"Duluth","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Hibbing Clinic","city":"Hibbing","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Sandstone","city":"Sandstone","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Virginia Clinic","city":"Virginia","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at Saint Peters Hospital","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at West County Hospital","city":"Creve Coeur","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center-South County","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siteman Cancer Center at Christian Hospital","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Hospital of Anaconda","city":"Anaconda","state":"Montana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Billings Clinic Cancer Center","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bozeman Health Deaconess Hospital","city":"Bozeman","state":"Montana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Benefis Sletten Cancer Institute","city":"Great Falls","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Logan Health Medical Center","city":"Kalispell","state":"Montana","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Community Medical Center","city":"Missoula","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Medicine-Bellevue","city":"Bellevue","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Medicine-Village Pointe","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Essentia Health Cancer Center-South University Clinic","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aultman Health Foundation","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-UC Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Case Western Reserve University","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Center-West Chester","city":"West Chester","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Providence Hood River Memorial Hospital","city":"Hood River","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Newberg Medical Center","city":"Newberg","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Willamette Falls Medical Center","city":"Oregon City","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Portland Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Saint Vincent Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Vermont Medical Center","city":"Burlington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Vermont and State Agricultural College","city":"Burlington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center-First Hill","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duluth Clinic Ashland","city":"Ashland","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center Green Bay","city":"Green Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center at Saint Mary's","city":"Green Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercyhealth Hospital and Cancer Center - Janesville","city":"Janesville","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gundersen Lutheran Medical Center","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - Eastpark Medical Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center - University Hospital","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert Menomonee Falls Hospital","city":"Menomonee Falls","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth D N Greenwald Center","city":"Mukwonago","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert and MCW Moorland Reserve Health Center","city":"New Berlin","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Drexel Town Square Health Center","city":"Oak Creek","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProHealth Oconomowoc Memorial Hospital","city":"Oconomowoc","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center at Oconto Falls","city":"Oconto Falls","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center at Sheboygan","city":"Sheboygan","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheboygan Physicians Group","city":"Sheboygan","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health-Spooner Clinic","city":"Spooner","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Vincent Hospital Cancer Center at Sturgeon Bay","city":"Sturgeon Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health Saint Mary's Hospital - Superior","city":"Superior","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UW Cancer Center at ProHealth Care","city":"Waukesha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert West Bend Hospital/Kraemer Cancer Center","city":"West Bend","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Complete response (CR) rate (CD10-negative diffuse large B cell lymphoma [DLBCL] and high grade B-cell lymphoma with MYC and BCL2 with or without BCL6 rearrangements [HGBCL-DH-BCL2])"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als"],"drugSlugs":[],"locationSlugs":["tucson-arizona","los-angeles-california","derby-connecticut","guilford-connecticut","new-haven-connecticut","coeur-dalene-idaho","post-falls-idaho","sandpoint-idaho","chicago-illinois","danville-illinois","dekalb-illinois","effingham-illinois","geneva-illinois","glenview-illinois","grayslake-illinois","lake-forest-illinois","mattoon-illinois","normal-illinois","oak-brook-illinois","orland-park-illinois","shiloh-illinois","urbana-illinois","warrenville-illinois","crown-point-indiana","dyer-indiana","hobart-indiana","indianapolis-indiana","munster-indiana","valparaiso-indiana","ames-iowa","ankeny-iowa","boone-iowa","carroll-iowa","cedar-rapids-iowa","clive-iowa","des-moines-iowa","fort-dodge-iowa","jefferson-iowa","marshalltown-iowa","waukee-iowa","new-orleans-louisiana","bethesda-maryland","escanaba-michigan","manistique-michigan","brainerd-minnesota","deer-river-minnesota","duluth-minnesota","hibbing-minnesota","sandstone-minnesota","virginia-minnesota","city-of-saint-peters-missouri","creve-coeur-missouri","st-louis-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","kalispell-montana","missoula-montana","bellevue-nebraska","omaha-nebraska","buffalo-new-york","durham-north-carolina","fargo-north-dakota","canton-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","west-chester-ohio","oklahoma-city-oklahoma","hood-river-oregon","newberg-oregon","oregon-city-oregon","portland-oregon","philadelphia-pennsylvania","burlington-vermont","charlottesville-virginia","richmond-virginia","seattle-washington","ashland-wisconsin","green-bay-wisconsin","janesville-wisconsin","la-crosse-wisconsin","madison-wisconsin","menomonee-falls-wisconsin","milwaukee-wisconsin","mukwonago-wisconsin","new-berlin-wisconsin","oak-creek-wisconsin","oconomowoc-wisconsin","oconto-falls-wisconsin","sheboygan-wisconsin","spooner-wisconsin","sturgeon-bay-wisconsin","superior-wisconsin","waukesha-wisconsin","west-bend-wisconsin"],"enrichment":{"headline":"Phase 2: testing Ibrutinib for High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements","inPlainEnglish":"This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors.","whoItsFor":["Ages 18 Years to any","Patient must be ≥ 18 years of age","Patient must have histologically or cytologically confirmed aggressive B-cell lymphoma as follows:","Cohort 1: CD10-negative DLBCL, which includes:","CD10-negative non-GCB DLBCL, not otherwise specified (NOS) (i.e., CD10-/BCL6- or CD10-/BCL6+/MUM1+ DLBCL)","CD10-negative GCB DLBCL, NOS (i.e., CD10-/BCL6+/MUM1- DLBCL)","CD10-negative HGBCL with MYC and BCL6 (without BCL2) translocations (HGBCL-DH-BCL6)","CD10-negative HGBCL, NOS (without MYC and BCL2 translocations)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Bone Marrow Aspiration. The registry lists allocation as na. This phase II trial tests how well venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid® (ViPOR) works in treating patients with CD10 negative diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma with MYC and BCL2 rearrangements that has come back after a period of improvement (relapsed) and/or that has not responded to previous treatment (refractory).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 115 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.637Z"},{"nctId":"NCT06651112","title":"The ATP Project (Antipsychotic-TEP-Psychosis)","officialTitle":"Impacts of Psychosis and Antipsychotics on Cerebral Energy Metabolism: the ATP Project (Antipsychotic-TEP-Psychosis)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Université de Sherbrooke","sponsorClass":"OTHER","summary":"The goal of this observational study is to the early impacts of psychosis and antipsychotic medications on brain metabolism in young adults recently diagnosed with a first episode of psychosis.\n\nThe main question aims to evaluate the effect of 4 to 6 weeks of antipsychotic medication on brain metabolism measured by PET scan (cerebral uptake of 11C-Acetoacetate + 18 Fluorodeoxyglucose).\n\nParticipants will undergo a multimodal imaging protocol with other measures of psychopathology (e.g., cognition, depressive symptoms, etc.) and (metabolic marker, inflammation, etc).","conditions":["First Episose Psychosis","Metabolic Disease","Psychosis; Episode"],"keywords":["psychosis","cerebral metabolism","glucose","ketone","PET scan"],"interventions":[{"type":"DRUG","name":"Antipsychotic drugs"}],"enrollment":18,"startDate":"2024-11-01","completionDate":"2027-12-01","sex":"ALL","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Admission to the PEP clinic in Estrie, either outpatient or inpatient, according to the transdiagnostic PEP model.\n* Willingness to begin taking an AP (regardless of type and dose, or change in type and dose during the study).\n* Ability to read and express themselves in French or English.\n* Capable of understanding and signing consent.\n\nExclusion Criteria:\n\n* Pregnancy, childbirth in the last 6 months, or breastfeeding.\n* Presence of a metallic object in the body that is incompatible with MRI.\n* Any use of APs for more than 2 continuous weeks in the past year and/or 6 weeks in a lifetime (except for aripiprazole if taken at less than 2.5 mg/day or quetiapine at less than 50 mg/day, regardless of duration or timing of the prescription).\n* The following comorbidities: psychosis + borderline or intellectual disability, autism spectrum disorder, substance use disorder with decompensation, psychosis induced by a medical condition, or psychosis induced by drug use or withdrawal.\n* Type 1 diabetes.\n* Uncontrolled acute suicidal ideation.\n* Other conditions that could interfere with participation according to the judgment of the qualified physician.","locations":[{"facility":"Hotel-Dieu CIUSSS de l'Estrie-CHUS","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melanie Fortier, M.Sc","phone":"8195758134","email":"melanie.fortier2@usherbrooke.ca"},{"name":"Stephen Cunnane, Ph.D.","phone":"819-780-2220","email":"melanie.fortier2@usherbrooke.ca"}],"primaryOutcomes":["Cerebral metabolic rate of glucose and acetotacetate","Net inflow of glucose and acetoacetate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["sherbrooke-canada"],"enrichment":{"headline":"Not a traditional drug phase: testing Antipsychotic drugs for First Episose Psychosis","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to the early impacts of psychosis and antipsychotic medications on brain metabolism in young adults recently diagnosed with a first episode of psychosis. The main question aims to measure the effect of 4 to 6 weeks of antipsychotic medication on brain metabolism measured by PET scan (cerebral uptake of 11C-Acetoacetate + 18 Fluorodeoxyglucose).","whoItsFor":["Ages 18 Years to 35 Years","Admission to the PEP clinic in Estrie, either outpatient or inpatient, according to the transdiagnostic PEP model","Willingness to begin taking an AP (regardless of type and dose, or change in type and dose during the study)","Ability to read and express themselves in French or English","Capable of understanding and signing consent"],"whoShouldSkip":["Pregnancy, childbirth in the last 6 months, or breastfeeding","Presence of a metallic object in the body that is incompatible with MRI","Any use of APs for more than 2 continuous weeks in the past year and/or 6 weeks in a lifetime (except for aripiprazole if taken at less than 2.5 mg/day or quetiapine at less than 50 mg/day, regardless of duration or timing of the prescription)","The following comorbidities: psychosis + borderline or intellectual disability, autism spectrum disorder, substance use disorder with decompensation, psychosis induced by a medical condition, or psychosis induced by drug use or withdrawal","Uncontrolled acute suicidal ideation","Other conditions that could interfere with participation according to the judgment of the qualified physician"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 18 people at Sherbrooke. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.048Z"},{"nctId":"NCT06651281","title":"Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)","officialTitle":"A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). An extension study is a type of study where people who received tulisokibart in certain other studies for CD or UC (called a parent study) may be able to join this study. The goals of this study are to learn about the safety of tulisokibart over time in people with CD or UC, and if people tolerate it.","conditions":["Crohn Disease","Colitis, Ulcerative"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tulisokibart"},{"type":"DRUG","name":"Placebo to tulisokibart"}],"enrollment":1380,"startDate":"2024-11-25","completionDate":"2037-12-17","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has participated in a qualifying tulisokibart parent study for CD or UC\n* The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study\n* A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention\n* A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention\n* A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)\n\nExclusion Criteria:\n\n* Has prematurely discontinued study intervention in their parent study\n* Has received any protocol-specified prohibited medications during their parent study\n* Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients","locations":[{"facility":"Connecticut Clinical Research Institute ( Site 0297)","city":"Bristol","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph Mercy Hospital - Huron Gastroenterology Associates ( Site 0287)","city":"Ypsilanti","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BVL Research - Kansas ( Site 0292)","city":"Liberty","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Gastroenterology Associates ( Site 0253)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Digestive Health Associates of Texas - DHAT ( Site 0290)","city":"Garland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Lubbock ( Site 0288)","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Caprock Gastro Research ( Site 0293)","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Star Research Institute ( Site 0299)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Southlake ( Site 0298)","city":"Southlake","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tyler Research Institute ( Site 0294)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Health System ( Site 0291)","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Gastroenterology - Tacoma ( Site 0295)","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vojenská Nemocnice Brno-Internal department ( Site 0701)","city":"Brno","state":"Brno-mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hepato-Gastroenterologie HK ( Site 0700)","city":"Hradec Králové","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nice - Hôpital l'Archet ( Site 1002)","city":"Nice","state":"Alpes-Maritimes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CMC Ambroise Paré Hartmann - Institut des MICI ( Site 1003)","city":"Neuilly-sur-Seine","state":"Hauts-de-Seine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU De Nancy - Hopital de Brabois ( Site 1001)","city":"Vandœuvre-lès-Nancy","state":"Meurthe-et-Moselle","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Claude Huriez CHRU LILLE ( Site 1004)","city":"Lille","state":"Nord","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARENSIA Exploratory Medicine Georgia ( Site 1104)","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház-4. Belgyogyaszat Gasztroenterologia ( Site 1411)","city":"Békéscsaba","state":"Bekes County","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem ( Site 1400)","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rivermed Sp. z.o.o. ( Site 2206)","city":"Poznan","state":"Greater Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. ( Site 2208)","city":"Włocławek","state":"Kuyavian-Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krakowskie Centrum Medyczne ( Site 2210)","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Oporow ( Site 2212)","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Melita Medical Sp. z o.o. ( Site 2204)","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Przychodnia Futuremeds Wroclaw ( Site 2211)","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"1 Wojskowy Szpital Kliniczny Z Poliklinika SPZOZ w Lublinie ( Site 2205)","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medrise Sp. z o.o. ( Site 2200)","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"EB Group Sp. Z o.o. Centrum Zdrowia MDM ( Site 2202)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vivamed Sp. z o.o. ( Site 2201)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"WIP Warsaw IBD Point Professor Kierkus ( Site 2209)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vita Longa Sp. Zoo ( Site 2213)","city":"Katowice","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sonomed Sp. z o. o. ( Site 2203)","city":"Szczecin","state":"West Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bonifraterskie Centrum Medyczne ( Site 2207)","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MAC Research - Merseyside ( Site 3401)","city":"Prescot","state":"Knowsley","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Whipps Cross University Hospital ( Site 3400)","city":"London","state":"Waltham Forest","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Number of Participants Who Experience an Adverse Event (AE)","Number of Participants Who Discontinue Study Treatment Due to an AE"],"hasResults":false,"conditionSlugs":["als","crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["bristol-connecticut","ypsilanti-michigan","liberty-missouri","new-york-new-york","garland-texas","lubbock-texas","san-antonio-texas","southlake-texas","tyler-texas","charlottesville-virginia","tacoma-washington","brno-czechia","hradec-kr-lov-czechia","nice-france","neuilly-sur-seine-france","vand-uvre-l-s-nancy-france","lille-france","tbilisi-georgia","b-k-scsaba-hungary","budapest-hungary","poznan-poland","w-oc-awek-poland","krakow-poland","wroclaw-poland","lublin-poland","warsaw-poland","katowice-poland","szczecin-poland","lodz-poland","prescot-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Tulisokibart for Crohn Disease","inPlainEnglish":"Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study. Tulisokibart is a medicine designed to treat active, moderate to severe Crohn's disease (CD) and ulcerative colitis (UC).","whoItsFor":["Has participated in a qualifying tulisokibart parent study for CD or UC","The investigator determines that the participant derives clinical benefit from continued study intervention based upon clinical evaluations performed during their parent study","A participant assigned female sex at birth is not breastfeeding during the study intervention period and for at least 14 weeks after the last dose of study intervention","A participant of childbearing potential (POCBP) is not pregnant and has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention","A POCBP uses an acceptable contraceptive method, or adheres to penile-vaginal intercourse abstinence as their preferred and usual lifestyle (abstinent on a long-term and persistent basis)"],"whoShouldSkip":["Has prematurely discontinued study intervention in their parent study","Has received any protocol-specified prohibited medications during their parent study","Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients"],"whatHappens":"If you join, the listed intervention(s) are Tulisokibart, or Placebo to tulisokibart. The registry lists allocation as randomized. Researchers want to learn more about tulisokibart (also known as MK-7240) in an extension study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,380 people at 37 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.885Z"},{"nctId":"NCT06651567","title":"A Study to Assess the Efficacy and Safety of ITI-1284 in the Treatment of Agitation Associated With Alzheimer's Dementia","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Flexible-dose Study of the Efficacy, Safety, and Tolerability of ITI-1284 in Patients With Agitation Associated With Alzheimer's Dementia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled, flexible-dose study of the efficacy, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.","conditions":["Agitation Associated With Alzheimer's Dementia"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITI-1284"},{"type":"DRUG","name":"Placebo"}],"enrollment":320,"startDate":"2024-10-22","completionDate":"2027-12-28","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Can understand the nature of the trial and protocol requirements and provide signed informed consent, if in the judgement of the Investigator is deemed competent to provide consent or if patient is deemed not competent to provide informed consent, with the patient's assent (if capable), consent may be provided by an appropriate person (eg, patient's Legally Authorized Representative \\[LAR\\]) before the initiation of any study-specific procedures in accordance with local regulations;\n* Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:\n\n  * Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or\n  * Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;\n* Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition\n* Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;\n* CGI-S score ≥ 4 at Screening and Baseline;\n* Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;\n\nExclusion Criteria:\n\n* Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;\n* Has been diagnosed with one or more of the following psychiatric conditions:\n\n  * Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;\n  * Bipolar disorder;\n  * Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;\n* Has a significant risk for suicidal behavior during the course of their participation in the study, or is considered to be an imminent danger to themselves or others, in the opinion of the investigator, and/or as assessed by Columbia Suicide Severity Rating Scale (C-SSRS); or the patient has had 1 or more suicide attempts within the 2 years prior to Screening;\n* The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients.","locations":[{"facility":"Advanced Research Center, Inc","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ATP Clinical Research","city":"Costa Mesa","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"National Institute Of Clinical Research","city":"Garden Grove","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Wr Pri Llc","city":"Newport Beach","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sunwise 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Viamed Montecanal","city":"Zaragoza","state":"","country":"Spain","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Cohen-Mansfield Agitation Inventory (CMAI) total score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["anaheim-california","costa-mesa-california","garden-grove-california","newport-beach-california","walnut-creek-california","boca-raton-florida","bonita-springs-florida","brandon-florida","delray-beach-florida","doral-florida","hialeah-florida","homestead-florida","maitland-florida","miami-florida","orlando-florida","tampa-florida","west-palm-beach-florida","boston-massachusetts","las-vegas-nevada","toms-river-new-jersey","raleigh-north-carolina","san-antonio-texas","lovech-bulgaria","pleven-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","zagreb-croatia","brno-czechia","choce-czechia","kutn-hora-czechia","pilsen-czechia","prague-czechia","bucharest-romania","com-sanpetru-romania","sibiu-romania","belgrade-serbia","kovin-serbia","ni-serbia","novi-kne-evac-serbia","bansk-bystrica-slovakia","bratislava-slovakia","ko-ice-slovakia","krompachy-slovakia","svidn-k-slovakia","vranov-nad-top-ou-slovakia","albacete-spain","badalona-spain","m-laga-spain","zamora-spain","zaragoza-spain"],"enrichment":{"headline":"Phase 2: testing ITI-1284 for Agitation Associated With Alzheimer's Dementia","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, flexible-dose study of the how well it works, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.","whoItsFor":["Ages 55 Years to any","Meets clinical criteria for Alzheimer's disease based on 2011 National Institute of Aging-Alzheimer's Association (NIA-AA) dementia criteria and biomarker criteria and either:","Has a high likelihood for amyloid pathology consistent with Alzheimer's disease, as confirmed by blood-based biomarker at Screening as detected by an appropriately validated test; or","Has historical documentation of cerebrospinal fluid (CSF) biomarker or amyloid positron emission tomography (PET) brain scan;","Meets all criteria for agitation according to the International Psychogeriatric Association (IPA) consensus definition","Has clinically meaningful agitation defined as a Neuropsychiatric Inventory-Agitation/Aggression (NPI-AA) domain total score of ≥ 4 at both Screening and Baseline;","CGI-S score ≥ 4 at Screening and Baseline;","Has Mini-Mental State Examination, 2nd Edition™: Standard Version (MMSE-2®:SV) score of 6 to 24 at Screening;"],"whoShouldSkip":["Agitation symptoms are attributable to concomitant medications, adverse environmental conditions, substance abuse, or active medical or psychiatric conditions as per Investigator's judgment;","Has been diagnosed with one or more of the following psychiatric conditions:","Schizophrenia, schizoaffective disorder, or other psychotic disorder that is not related to Alzheimer's dementia;","Major depressive disorder, unless it is considered stable and treated for at least 8 weeks prior to Screening;","The patient has known hypersensitivity or intolerance to ITI-1284 or lumateperone, or to any of their excipients"],"whatHappens":"If you join, the listed intervention(s) are ITI-1284, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, flexible-dose study of the how well it works, safety, and tolerability of ITI-1284 in patients with agitation associated with Alzheimer's dementia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 320 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.333Z"},{"nctId":"NCT06653738","title":"Trial to Assess the Efficacy of EMPAgliflozin and Personalized Dietary Counseling for Kidney STONE Prevention","officialTitle":"Randomized Placebo-controlled Trial to Assess Efficacies of EMPAgliflozin and Personalized Dietary Counselling for Kidney STONE Prevention in Patients With Calcium Kidney Stones Acronym: EMPASTONE Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"QUADRUPLE","sponsor":"Insel Gruppe AG, University Hospital Bern","sponsorClass":"OTHER","summary":"The aim of this randomized trial with a 2-by-2 factorial design is to test the efficacy of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones.\n\nStudy interventions:\n\n* Empagliflozin 10 mg once daily per os for 36 months\n* Personalized dietary counseling for 36 months.\n\nControl interventions:\n\n* Placebo once daily per os for 36 months\n* Generic dietary counseling for 36 months.","conditions":["Kidney Stone","Nephrolithiasis","Dietary Exposure"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"},{"type":"DRUG","name":"Placebo"},{"type":"BEHAVIORAL","name":"Personalized dietary counseling"},{"type":"BEHAVIORAL","name":"Generic dietary counseling"}],"enrollment":400,"startDate":"2026-07-02","completionDate":"2030-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Written, informed consent.\n2. Age 18 years or older.\n3. Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization.\n4. Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both.\n5. If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts), patients must have been on a stable regimen for at least 60 days before randomization and willing to remain on this stable regimen for the duration of the study.\n\nExclusion criteria:\n\n1. Known history of secondary or Mendelian causes of calcium nephrolithiasis\n2. Type I diabetes mellitus\n3. History of ketoacidosis\n4. Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \\<30 mL/min)\n5. Kidney transplant recipient\n6. History of recurrent urinary tract infections, defined as \\>3 episodes within the year prior to randomization\n7. Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment\n8. Treatment with an SGLT2i within 4 weeks prior to randomization.\n9. Active cancer treatment\n10. Pregnancy and/or breastfeeding. Women of childbearing potential (i.e., premenopausal women who have not undergone surgical sterilization and are sexually active with a male partner) must have a negative urine or blood pregnancy test prior to enrollment\n11. Known allergy to the study drug\n12. Inability to understand and follow the study procedures\n13. Vulnerable individual, e.g. individual incapable of judgement or currently incarcerated or otherwise institutionalized (priosner), or refugee\n14. Concomitant participation in another interventional clinical trial within 4 weeks prior to randomization and during the current trial\n15. Prior enrollment in the EMPASTONE trial","locations":[{"facility":"University Hospital Amiens-Picardie","city":"Amiens","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Tenon","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Européen Georges Pompidou","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Charité University Medicine Berlin","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Università della Campania \"Luigi Vanvitelli\"","city":"Naples","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Verona University Hospital","city":"Verona","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Aarau","city":"Aarau","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Baden","city":"Baden","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inselspital Bern","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Chur","city":"Chur","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Fribourg","city":"Fribourg","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Geneva (HUG)","city":"Geneva","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lausanne University Hospital (CHUV)","city":"Lausanne","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Luzern","city":"Lucerne","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Regionalspital Lugano","city":"Lugano","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Neuchâtel","city":"Neuchâtel","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Olten","city":"Olten","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital St. Gallen","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Sion","city":"Sion","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsspital Zürich","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel G Fuster, Prof MD","phone":"+41 31 632 31 44","email":"daniel.fuster@unibe.ch"}],"primaryOutcomes":["Number of patients with radiologic stone recurrence"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["empagliflozin"],"locationSlugs":["amiens-france","paris-france","berlin-germany","naples-italy","verona-italy","aarau-switzerland","baden-switzerland","basel-switzerland","bern-switzerland","chur-switzerland","fribourg-switzerland","geneva-switzerland","lausanne-switzerland","lucerne-switzerland","lugano-switzerland","neuch-tel-switzerland","olten-switzerland","sankt-gallen-switzerland","sion-switzerland","zurich-switzerland"],"enrichment":{"headline":"Phase 3: testing Empagliflozin 10 MG for Kidney Stone","inPlainEnglish":"The aim of this randomly assigned trial with a 2-by-2 factorial design is to test the how well it works of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones. Study interventions: * Empagliflozin 10 mg once daily per os for 36 months * Personalized dietary counseling for 36 months.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Recurrent kidney stone disease with 2 or more stone episodes in the last 10 years prior to randomization","Last kidney stone containing 50% or more of CaOx, CaP or a mixture of both","If taking guideline-recommended medications for kidney stone prophylaxis (e.g. citrate salts), patients must have been on a stable regimen for at least 60 days before randomization and willing to remain on this stable regimen for the duration of the study"],"whoShouldSkip":["Known history of secondary or Mendelian causes of calcium nephrolithiasis","Type I diabetes mellitus","History of ketoacidosis","Chronic Kidney Disease (CKD) stage 4 or 5 (defined as CKD-EPI eGFR \\<30 mL/min)","Kidney transplant recipient","History of recurrent urinary tract infections, defined as \\>3 episodes within the year prior to randomization","Heart failure. Symptomatic patients with suspected heart failure must be evaluated before study enrollment"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG, Placebo, or Personalized dietary counseling. The registry lists allocation as randomized. The aim of this randomly assigned trial with a 2-by-2 factorial design is to test the how well it works of the SGLT2 inhibitor empagliflozin and personalized dietary counseling based on 24-hr urine collection results and dietary assessments for kidney stone recurrence prevention in patients with calcium kidney stones.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.615Z"},{"nctId":"NCT06654752","title":"Streamlined Treatment of Pulmonary Exacerbations in Pediatrics","officialTitle":"Streamlined Treatment of Pulmonary Exacerbations in Pediatrics Randomized Controlled Trial (STOP PEDS RCT)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Washington, the Collaborative Health Studies Coordinating Center","sponsorClass":"OTHER","summary":"The STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.","conditions":["Cystic Fibrosis"],"keywords":["cystic fibrosis","oral antibiotics","pulmonary exacerbation","pediatric"],"interventions":[{"type":"OTHER","name":"Immediate Oral Antibiotics"},{"type":"OTHER","name":"Tailored Treatment: Oral Antibiotics only if Additional Treatment needed"}],"enrollment":430,"startDate":"2024-12-01","completionDate":"2027-12-30","sex":"ALL","minAge":"3 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age\n\n   1. For main cohort and non-HEMT cohort: age 6 to \\<19 years\n   2. For preschool cohort: age 3 to \\<6 years\n2. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:\n\n   1. sweat chloride ≥ 60 mEq/liter\n   2. two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene\n3. Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study\n4. Highly Effective Modulator Therapy\n\n   1. For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment\n   2. For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months\n5. For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry\n6. For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations\n7. Ability to receive text messages and access the internet\n\nExclusion Criteria:\n\n1. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data\n2. Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report\n3. Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report\n4. History of solid organ transplant\n5. History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment\n6. Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment\n7. Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment\n8. Treatment with chronic oral antibiotics other than azithromycin at enrollment\n9. Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment","locations":[{"facility":"The Children's Hospital Alabama & University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tucson Cystic Fibrosis Center","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rady Children's Hospital at University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta & Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children & Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital, Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital & Harvard University","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Health System","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospitals and Clinics of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Minnesota Cystic Fibrosis Center & University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Mercy Hospital","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Louis Children's Hospital & Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center Strong Memorial","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia & University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern & Children's Health","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Children's Hospital & Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vermont Children's Hospital & University of Vermont Medical Center","city":"Burlington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Wisconsin & Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"British Columbia Children's Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erika Enright","phone":"206-897-1922","email":"eenright@uw.edu"}],"primaryOutcomes":["One-year change in pulmonary function by spirometry-measured ppFEV1"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["birmingham-alabama","tucson-arizona","los-angeles-california","palo-alto-california","san-diego-california","aurora-colorado","atlanta-georgia","chicago-illinois","indianapolis-indiana","iowa-city-iowa","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","minneapolis-minnesota","kansas-city-missouri","st-louis-missouri","rochester-new-york","chapel-hill-north-carolina","cincinnati-ohio","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","charleston-south-carolina","dallas-texas","houston-texas","burlington-vermont","richmond-virginia","seattle-washington","madison-wisconsin","milwaukee-wisconsin","vancouver-canada","toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: Immediate Oral Antibiotics for Cystic Fibrosis","inPlainEnglish":"The STOP PEDS RCT is a multicenter, parallel, open label randomly assigned controlled trial evaluating the long-term (one year) and short-term safety and how well it works of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.","whoItsFor":["Ages 3 Years to 18 Years","For main cohort and non-HEMT cohort: age 6 to \\<19 years","For preschool cohort: age 3 to \\<6 years","Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:","sweat chloride ≥ 60 mEq/liter","two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene","Highly Effective Modulator Therapy","For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment"],"whoShouldSkip":["Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data","Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report","Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report","History of solid organ transplant","History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment","Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment","Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment"],"whatHappens":"If you join, the listed intervention(s) are Immediate Oral Antibiotics, or Tailored Treatment: Oral Antibiotics only if Additional Treatment needed. The registry lists allocation as randomized. The STOP PEDS RCT is a multicenter, parallel, open label randomly assigned controlled trial evaluating the long-term (one year) and short-term safety and how well it works of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 430 people at 33 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.423Z"},{"nctId":"NCT06654882","title":"Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis","officialTitle":"Trial of Sequential Medications AfteR TNFi Failure in Juvenile Idiopathic Arthritis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"This study is an open-label, randomized, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomized trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi. The second randomization allows identification of optimal sequential use of biologics (treatment strategies).","conditions":["Polyarticular Course Juvenile Idiopathic Arthritis (JIA)"],"keywords":["JIA","Rheumatology"],"interventions":[{"type":"DRUG","name":"TNFi (Tumor Necrosis Factor inhibitor) medication"},{"type":"DRUG","name":"Abatacept"},{"type":"DRUG","name":"Tocilizumab"},{"type":"DRUG","name":"Tofacitinib"}],"enrollment":400,"startDate":"2026-01-09","completionDate":"2029-05-30","sex":"ALL","minAge":"2 Years","maxAge":"21 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Polyarticular course JIA\n* Moderate or high-disease activity (cJADAS10 \\>5) despite treatment with an initial TNFi for ≥2 months\n* Age ≥2 years and \\<21 years and weight ≥ 10kg\n* No systemic glucocorticoids or systemic glucocorticoids at a stable dose of ≤0.2 mg/kg/day (maximum 10 mg/day) for ≥2 weeks prior to baseline visit\n* Documented informed consent/assent obtained from the parent/caregiver/patient\n\nExclusion Criteria:\n\n* Systemic JIA\n* Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology \\[ILAR\\] criteria)30\n* History of or currently active inflammatory bowel disease\n* History of or currently active psoriasis\n* Active uveitis within 3 months of the baseline visit\n* History of or currently active sacroiliitis\n* History of or current malignancy\n* Active tuberculosis (TB) or a history of incompletely treated TB; Purified Protein derivative (PPD) or QuantiFERON-TB positive patients (without active TB) unless it is documented that the patient has been adequately treated for TB and can start treatment with a biologic agent, based on the medical judgment of the site investigator and/or an infectious disease specialist; suspected extrapulmonary TB infection; or at high risk of contracting TB, such as close contact with individual with active or latent TB\n* Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed\n* Prior treatment with non-TNFi bDMARDs and/or any JAKi\n* Aspartate aminotransferase (AST) or alanine transaminase (ALT) ≥3 × upper limit of normal (ULN) for age and sex\n* Serum creatinine \\>1.5 × ULN for age and sex\n* Platelet count \\<150 × 103/μL (\\<150,000/mm3)\n* Hemoglobin \\<7.0 g/dL (\\<4.3 mmol/L)\n* White blood cell (WBC) count \\<3,000/mm3 (\\<3.0 × 109/L)\n* Neutrophil count \\<1,500/mm3 (\\<1.5 × 109/L)\n* Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit\n* Any live attenuated vaccine, such as varicella-zoster, oral polio, measles, mumps or rubella vaccines, within 4 weeks prior to the baseline visit.\n* Any medical history that may be considered a contraindication/safety concern with the use of adalimumab, etanercept, tofacitinib, ABA, or an IL-6 inhibitor or their biosimilars. In particular, subjects at known high risk for venous thromboembolism will be excluded, including recent heart failure or prior myocardial infarction, known inherited thrombotic risk factors, history of venous thromboembolism (deep venous thrombosis or pulmonary embolism, undergoing major surgery, or are chronically immobilized).\n* Pregnant or breastfeeding\n* Sexually active females of childbearing potential who refuse to use at least one required contraception method (See Contraception paragraph 8.9 for definition of childbearing potential and details).\n* History of hypersensitivity or allergic reaction to any study drug or any of its excipients (inactive ingredients).","locations":[{"facility":"University of California San Francisco Pediatric Rheumatology","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Meridian Health - Joseph M. Sanzari Children's Hospital","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Children's Hospital","city":"Sankt Augustin","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Giannina Gaslini Institute","city":"Genoa","state":"Liguria","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Utrecht (Universitair Medisch Centrum Utrecht)","city":"Utrecht","state":"Utrecht","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laura E Schanberg (Contact PI)","phone":"919-373-3863","email":"laura.schanberg@duke.edu"},{"name":"Huiman Barnhart (Dual PI)","phone":"919-668-8828","email":"huiman.barnhart@duke.edu"}],"primaryOutcomes":["Number of participants with MiDA"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["san-francisco-california","gainesville-florida","hackensack-new-jersey","columbus-ohio","sankt-augustin-germany","genoa-italy","utrecht-netherlands"],"enrichment":{"headline":"Phase 3: testing TNFi (Tumor Necrosis Factor inhibitor) medication for Polyarticular Course Juvenile Idiopathic Arthritis (JIA)","inPlainEnglish":"This study is an open-label, randomly assigned, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomly assigned trial design with 2 randomization stages corresponding with clinical decision points. The first randomization addresses whether each of the 3 non-TNFi medications is superior to treatment with a second TNFi.","whoItsFor":["Ages 2 Years to 21 Years","Polyarticular course JIA","Moderate or high-disease activity (cJADAS10 \\>5) despite treatment with an initial TNFi for ≥2 months","Age ≥2 years and \\<21 years and weight ≥ 10kg","No systemic glucocorticoids or systemic glucocorticoids at a stable dose of ≤0.2 mg/kg/day (maximum 10 mg/day) for ≥2 weeks prior to baseline visit"],"whoShouldSkip":["Enthesitis-related arthritis/juvenile spondyloarthritis (2001 International League of Associations for Rheumatology \\[ILAR\\] criteria)30","History of or currently active inflammatory bowel disease","History of or currently active psoriasis","Active uveitis within 3 months of the baseline visit","History of or currently active sacroiliitis","History of or current malignancy","Prior treatment with more than one TNFi molecule; exposure to more than one biosimilar of the same TNFi molecule is allowed"],"whatHappens":"If you join, the listed intervention(s) are TNFi (Tumor Necrosis Factor inhibitor) medication, Abatacept, or Tocilizumab. The registry lists allocation as randomized. This study is an open-label, randomly assigned, multicenter trial that incorporates a multi-arm design comparing each of 3 non-TNFi (Tumor Necrosis Factor inhibitor) medications to a second TNFi (active control) within a sequential multiple assignment randomly assigned trial design with 2 randomization stages corresponding with clinical decision points.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.265Z"},{"nctId":"NCT06655454","title":"Supplemental Postoperative Bupivacaine Following Non-Surgical Endodontic Treatment","officialTitle":"The Effects of Supplemental Postoperative 0.5% Bupivacaine With 1:200,000 Epinephrine Following Non-Surgical Endodontic Treatment on Patients' Quality of Life, Pain, and Analgesic Consumption","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"New York University","sponsorClass":"OTHER","summary":"The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.","conditions":["Pain Assessment","Quality of Life (QOL)","Analgesic Use"],"keywords":["bupivacaine","nonsurgical endodontic treatment","root canal therapy","irreversible pulpitis","pain management","anesthetic use"],"interventions":[{"type":"DRUG","name":"Supplemental Postoperative Bupivacaine"},{"type":"DRUG","name":"Placebo Injection"}],"enrollment":150,"startDate":"2024-11-01","completionDate":"2027-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Medical ASA Class I or II\n2. Patients above 18 years old\n3. Patients with a blood pressure below 160/100\n4. Patients who are treatment planned and have agreed to have emergency endodontic therapy or non-surgical root canal therapy with a pulpal diagnosis of symptomatic irreversible pulpitis according to the AAE Glossary of Endodontic Terms.\n5. Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English.\n\nExclusion Criteria:\n\n1. Medical ASA III or above\n2. Patients who reported the use of tobacco or nicotine-containing products such as vapes, e-cigarettes, gums, or pouches and will not in the 48 hours following treatment\n3. Patients who reported the use of any marijuana products or illicit drugs in the 48 hours prior to treatment and will not in the next 48 hours.\n4. Patients who have taken opioids to control pain.\n5. Pregnant patients\n6. Patients with a blood pressure of 160/100 or greater\n7. Patients with a known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study.\n8. Patients who have more than one tooth with odontogenic pain at the time of the screening.\n9. Patients who are unable to consent and do not understand or are unable to read the questionnaires.\n10. Patients who have had 4 1.7 ml carpules or more of anesthetic (Lidocaine and/ or Septocaine, 1:100,000) during standard care of treatment.","locations":[{"facility":"New York University College of Dentistry","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lorel E Burns, DDS","phone":"212-998-9332","email":"leb409@nyu.edu"},{"name":"NYUSOM IRB","phone":"212-263-4110","email":"irb-info@nyulangone.org"}],"primaryOutcomes":["Quality of life (scored based on the OHIP-14 questionnaire)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Supplemental Postoperative Bupivacaine for Pain Assessment","inPlainEnglish":"The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment. The long-acting anesthetic will be compared to a mock injection group and a group with no additional anesthetic to determine any differences in effects.","whoItsFor":["Ages 18 Years to any","Medical ASA Class I or II","Patients above 18 years old","Patients with a blood pressure below 160/100","Patients who are treatment planned and have agreed to have emergency endodontic therapy or non-surgical root canal therapy with a pulpal diagnosis of symptomatic irreversible pulpitis according to the AAE Glossary of Endodontic Terms","Patients must be able to comprehend and complete all study protocols, written consent, and questionnaires in English"],"whoShouldSkip":["Medical ASA III or above","Patients who reported the use of tobacco or nicotine-containing products such as vapes, e-cigarettes, gums, or pouches and will not in the 48 hours following treatment","Patients who reported the use of any marijuana products or illicit drugs in the 48 hours prior to treatment and will not in the next 48 hours","Patients who have taken opioids to control pain","Patients with a blood pressure of 160/100 or greater","Patients with a known hypersensitivity or allergy to any local anesthetic agent of the amide group, or any other components of the two anesthetic solutions such as epinephrine, sodium metabisulfite used in the study","Patients who have more than one tooth with odontogenic pain at the time of the screening"],"whatHappens":"If you join, the listed intervention(s) are Supplemental Postoperative Bupivacaine, or Placebo Injection. The registry lists allocation as randomized. The study will investigate the impact of an additional injection of long-acting anesthetic on pain level, quality of life, and use of pain medication after a nonsurgical endodontic treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.062Z"},{"nctId":"NCT06656416","title":"ALTO-100 in Bipolar Disorder With Depression (BD-D)","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study Followed by Open-Label Treatment of ALTO-100 in Adults With Bipolar Disorder Currently Experiencing a Major Depressive Episode","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Alto Neuroscience","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess antidepressant efficacy differences between ALTO-100 and placebo during the Double-Blind period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and efficacy will be assessed in a subsequent open label treatment period.","conditions":["Bipolar Disorder I or II With a Major Depressive Episode"],"keywords":["Bipolar I","Bipolar II","Major Depressive Episode"],"interventions":[{"type":"DRUG","name":"ALTO-100"},{"type":"DRUG","name":"Placebo"}],"enrollment":200,"startDate":"2024-10-02","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a diagnosis of BD-I or BD-II as well as BD-D\n* At baseline, taking a mood stabilizer, lithium (LI) or lamotrigine (LMG) or valproic acid (VPA, any form) or combination of Li + LMG or Li + VPA and/or taking an approved atypical antipsychotic medication (olanzapine, quetiapine, lurasidone, risperidone, ziprasidone, cariprazine, aripiprazole, lumateperone, asenapine, Iloperidone and Milsaperidone) for at least 6 weeks with no dose modifications in the past 2 weeks\n* Willing to comply with all study assessments and procedures\n* Must not be pregnant or breastfeeding at time of enrollment or throughout study\n\nExclusion Criteria:\n\n* Evidence of unstable medical condition\n* Concurrent use of any prohibited medications or substance use disorder\n* Diagnosed psychotic disorder (other than mania or depression)\n* Current moderate or severe substance use disorder\n* Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients\n* Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device","locations":[{"facility":"Site 6074","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Site 6036","city":"Chandler","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Site 6000","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 6087","city":"Yuma","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"6039","city":"Fayetteville","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"6070","city":"Little Rock","state":"Arkansas","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Site 6133","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 6153","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 6081","city":"Imperial","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"6069","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 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Neuroscience","phone":"650-200-0412","email":"clinical@altoneuroscience.com"}],"primaryOutcomes":["To assess efficacy of ALTO-100 versus placebo on depression symptoms in bipolar disorder in a pre-defined subgroup of participants as measured by the mean change from Day 1 to Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","chandler-arizona","phoenix-arizona","yuma-arizona","fayetteville-arkansas","little-rock-arkansas","chino-california","imperial-california","los-angeles-california","mather-california","oceanside-california","riverside-california","sacramento-california","san-jose-california","colorado-springs-colorado","jacksonville-florida","lauderhill-florida","pinellas-park-florida","tampa-florida","atlanta-georgia","peachtree-corners-georgia","chicago-illinois","carmel-indiana","west-lafayette-indiana","baltimore-maryland","bel-air-maryland","gaithersburg-maryland","towson-maryland","worcester-massachusetts","ann-arbor-michigan","grand-rapids-michigan","flowood-mississippi","lincoln-nebraska","las-vegas-nevada","toms-river-new-jersey","albuquerque-new-mexico","amherst-new-york","new-york-new-york","cary-north-carolina","rose-hill-north-carolina","cincinnati-ohio","north-canton-ohio","westlake-ohio","austin-texas","beaumont-texas","dallas-texas","houston-texas","plano-texas","draper-utah","fairfax-virginia","bellevue-washington","derby-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","liverpool-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","oxford-united-kingdom","southampton-united-kingdom","york-united-kingdom"],"enrichment":{"headline":"Phase 2: testing ALTO-100 for Bipolar Disorder I or II With a Major Depressive Episode","inPlainEnglish":"This study wants to assess antidepressant how well it works differences between ALTO-100 and dummy treatment (placebo) during the neither you nor the study doctors know who gets the real treatment period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics. Additionally, safety, tolerability, and how well it works will be assessed in a subsequent open label treatment period.","whoItsFor":["Ages 18 Years to 70 Years","Have a diagnosis of BD-I or BD-II as well as BD-D","Must not be pregnant or breastfeeding at time of enrollment or throughout study"],"whoShouldSkip":["Evidence of unstable medical condition","Concurrent use of any prohibited medications or substance use disorder","Diagnosed psychotic disorder (other than mania or depression)","Current moderate or severe substance use disorder","Has a history of hypersensitivity or allergic reaction to ALTO-100 or any of its components/excipients","Concurrent or recent participation in another clinical trial for mental illness involving an investigational product or device"],"whatHappens":"If you join, the listed intervention(s) are ALTO-100, or Placebo. The registry lists allocation as randomized. This study wants to assess antidepressant how well it works differences between ALTO-100 and dummy treatment (placebo) during the neither you nor the study doctors know who gets the real treatment period in patients with bipolar disorder I or II with current major depressive episode, when used adjunctively to a mood stabilizer and/or atypical antipsychotic, related to patient characteristics.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at 68 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.743Z"},{"nctId":"NCT06659341","title":"A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation","officialTitle":"Phase 1 Study of a SOS1 Inhibitor, BAY 3498264, in Combination in Participants With Advanced KRASG12C-mutated Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Bayer","sponsorClass":"INDUSTRY","summary":"Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation.\n\nSotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by doctors. However, when sotorasib works, it normally only works for a period of time, after which the cancer starts to grow again, and the patient may need a different treatment.\n\nBAY3498264 is a drug that is currently under development. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; by blocking the activity of SOS1 with BAY3498264, it is hoped that the benefit offered by treatment with sotorasib may be increased - for example, resulting in a longer or deeper response.\n\nThe main purpose of this first-in-human study is to learn how safe BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib.\n\nDuring the study, participants will receive the following treatments:\n\n* BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days.\n* Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264.\n\nThe treatment will continue for as long as participants benefit from it without any severe medical problems or until they or their doctor decide to stop the treatment, or until their cancer starts to grow again despite the treatment (also called 'progression').\n\nThis study has 3 parts, the dose escalation part, the backfill part and the expansion part.\n\nDuring the study, researchers will collect blood, urine, and take imaging scans like CT, PET, MRI, and X-rays, and examine the participants' heart health using an electrocardiogram (ECG). Participants' health is monitored throughout the study.","conditions":["Advanced Solid Tumors Harboring KRAS G12C Mutation"],"keywords":[],"interventions":[{"type":"DRUG","name":"BAY3498264"}],"enrollment":104,"startDate":"2024-11-08","completionDate":"2027-04-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed solid tumor malignancy with documented KRAS\\^G12C mutation as assessed by an appropriately accredited laboratory.\n* Documented disease progression after treatment with at least 1 prior standard of care (SoC) systemic therapy other than a G12C inhibitor for locally advanced or metastatic disease, and with no further standard treatment options available, or when standard treatment options are not acceptable and this study is a reasonable option.\n\n  * Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate.\n  * Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance.\n* Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible.\n* Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks.\n\nExclusion Criteria:\n\n\\- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening.\n\n1. 'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator).\n2. Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before the start of study intervention may be eligible if, at the point of study entry:\n\ni. their condition is considered stable by the investigator. ii. they have no residual neurological symptoms (Grade \\>2). iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions.\n\niv. they do not need systemic corticosteroids to treat symptoms of brain metastasis.\n\n* Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:\n\n  1. Grade ≥2 ILD,\n  2. Drug-induced ILD,\n  3. Radiation pneumonitis that required steroid treatment within the last 12 months.\n* Additional malignancy within the past 3 years, except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, in agreement with the Sponsor, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.\n* Any positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating the presence of virus.\n\n  * Active HBV (chronic or acute; defined as having a known positive HBsAg test at the time of screening) except for participants on antiviral therapy for HBV with an undetectable or low viral load.\n  * Participants with past HBV infection or resolved HBV infection (defined as the presence of HBcAb and absence of HBsAg) are eligible if HBV DNA is negative.\n  * Participants positive for HCV antibody unless polymerase chain reaction is negative for HCV RNA. Any prior antiviral therapy must be completed at least 28 days before the first dose of study intervention.","locations":[{"facility":"Border Medical oncology - Albury Wodonga Regional Cancer Centre","city":"Albury","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University Hospital - Oncology Department","city":"Macquarie Park","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula and Southeast Oncology","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cabrini Health Oncology Research","city":"Malvern","state":"Victoria","country":"Australia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rigshospitalet Copenhagen University Hospital | Oncology Department","city":"Copenhagen","state":"Capital Region / Region Hovedstaden","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia","city":"Rozzano","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall D Hebron | Oncologia","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Catala D'oncologia | Hospitalet | Oncologia","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital | Oncology","city":"Manchester","state":"Greater Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden (Surrey) | Oak Foundation Drug Development Unit","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bayer Clinical Trials Contact","phone":"0018888422937","email":"clinical-trials-contact@bayer.com"}],"primaryOutcomes":["Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) categorized by severity.","Maximum tolerated dose (MTD) or Maximum administered dose (MAD) of BAY 3498264 in combination with sotorasib.","Number of participants with Dose-limiting toxicity (DLTs) during the DLT observation period categorized by severity.","Maximum observed drug concentration in plasma (Cmax) of the respective dosing interval of BAY3498264 after single dose and multiple dose administrations.","Area under the concentration vs. time curve (AUC) of the respective dosing interval of BAY3498264 after single dose and multiple dose administrations."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["sotorasib"],"locationSlugs":["albury-australia","macquarie-park-australia","frankston-australia","malvern-australia","copenhagen-denmark","rome-italy","rozzano-italy","barcelona-spain","manchester-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing BAY3498264 for Advanced Solid Tumors Harboring KRAS G12C Mutation","inPlainEnglish":"Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation. Sotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death.","whoItsFor":["Ages 18 Years to any","Histologically confirmed solid tumor malignancy with documented KRAS\\^G12C mutation as assessed by an appropriately accredited laboratory","Participants whose access to SoC therapies is limited due to regional access, refusal, intolerance, or eligibility may participate","Prior G12C inhibitor treatment is permitted. Participants receiving prior G12C inhibitor therapy must have documented disease progression after treatment, or have discontinued that treatment due to intolerance","Adequate archival formalin-fixed paraffin-embedded tumor tissue available (preferably no older than 6 months, obtained after the last targeted therapy). If archival material is not available, a fresh tumor biopsy should ideally be obtained if safe and feasible","Eastern Cooperative Oncology Group (ECOG) of 0 to 2 and life expectancy of at least 12 weeks"],"whoShouldSkip":["\\- Active central nervous system (CNS) tumors including metastatic brain disease, at the time of screening","'Active' is defined as untreated brain lesions (new or progressing) or symptomatic brain lesions (as determined by the investigator)","Participants who have received treatment (e.g. surgery or radiotherapy) for brain metastases ending at least 4 weeks before the start of study intervention may be eligible if, at the point of study entry:","i. their condition is considered stable by the investigator. ii. they have no residual neurological symptoms (Grade \\>2). iii. a follow-up Magnetic resonance imaging (MRI) scan during the screening period shows no progression or new lesions","iv. they do not need systemic corticosteroids to treat symptoms of brain metastasis","Any grade active pneumonitis or interstitial lung disease (ILD), or past medical history of:","Radiation pneumonitis that required steroid treatment within the last 12 months"],"whatHappens":"If you join, the listed intervention(s) are BAY3498264. The registry lists allocation as randomized. Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 104 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.967Z"},{"nctId":"NCT06659549","title":"A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD","officialTitle":"A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Galimedix Therapeutics Inc","sponsorClass":"INDUSTRY","summary":"Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.","conditions":["Geographic Atrophy of the Macula"],"keywords":["AMD","Geographic Atrophy","Age Related Macular Degeneration","Amyloid-Beta","Eye-drops"],"interventions":[{"type":"DRUG","name":"GAL-101"},{"type":"DRUG","name":"Placebo"}],"enrollment":110,"startDate":"2025-01-10","completionDate":"2028-03-30","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥55 years of age\n* Willing and able to provide written informed consent\n* Willing and able to comply with the study schedule and study assessments\n* Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution\n* BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline\n* Refractive error between +3 and -6 diopters spherical equivalent in the study eye\n* Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline\n* Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center\n\n  1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2\n  2. If GA is multifocal, at least 1 lesion ≥1.25 mm2\n  3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \\[RPE\\] and outer retina)\n  4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea\n  5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \\>300 µm from image edges\n  6. GA lesions must be \\>300 µm from the optic disc and/or peripapillary atrophy\n  7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2\n\nExclusion Criteria:\n\n1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline\n2. History of laser therapy in the macular region, regardless of indication\n3. History of herpes zoster\n4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period\n5. GA with cumulative area \\<1.25 mm2\n6. Any GA lesion within 100 µm radius from the center point of the fovea\n7. Axial length \\>26 mm\n8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.)\n9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period\n10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period\n11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period\n12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period\n\n    Non-study Eye:\n13. BCVA of \\<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)\n\n    Either Eye:\n14. History of uveitis\n15. GA secondary to any condition other than non-neovascular AMD\n16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline\n17. Underwent investigational treatment for AMD within 6 months before Visit 1a\n\n    General Exclusion Criteria:\n18. History of therapeutic radiation to the cranium\n19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients\n20. History of malignant disease\n21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period\n22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period\n23. Use of lutein \\>10 mg per day or zeaxanthin \\>2 mg per day within 1 month before Visit 1a, or planned use during the study period\n24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data\n25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation\n26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline\n27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP","locations":[{"facility":"Retina-Vitreous Associates Medical Group","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bay Area Retina Associates","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cumberland Valley Retina Consultants","city":"Hagerstown","state":"Maryland","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Ophthalmological Center After S.V. Malayan","city":"Yerevan","state":"","country":"Armenia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Rétine Gallien","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital de La Croix-Rousse Service D'Ophtalmologie Groupement Hospitalier Nord Hospices Civils de Lyon","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Monticelli Paradis d'Ophtalmologie","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Ophtalmologique Odéon","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre médico-chirurgical de Touraine","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Akhali Mzera Limited","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Caucasus Medical Centre LLC","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitäts-Augenklinik Bonn","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Freiburg Klinik für Augenheilkunde","city":"Freiburg im Breisgau","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Hochschule Hannover Augenklinik","city":"Hanover","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dietrich Bonhoeffer Klinikum","city":"Neubrandenburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen, Department für Augenheilkunde.","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNIVERSITÄTSKLINIKUM ULM Klinik für Augenheilkunde","city":"Ulm","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UPMC Kildare Hospital Prosperous Rd Clane, Kildare Ireland","city":"Kildare","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Eye Surgery (IOES Waterford)","city":"Waterford","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unità di Oculistica, IRCCS Ospedale San Raffaele","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"UOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia","city":"Roma","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Galimedix Inc. c/o Imperial CRS, MD","phone":"+1 (301) 9179191","email":"info@galimedix.com"},{"name":"Luciana Summo, PhD","phone":"","email":"info@galimedix.com"}],"primaryOutcomes":["Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size."],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["beverly-hills-california","walnut-creek-california","hagerstown-maryland","yerevan-armenia","bordeaux-france","lyon-france","marseille-france","paris-france","tours-france","tbilisi-georgia","bonn-germany","freiburg-im-breisgau-germany","hanover-germany","neubrandenburg-germany","t-bingen-germany","ulm-germany","kildare-ireland","waterford-ireland","jerusalem-israel","tel-aviv-israel","milan-italy","roma-italy"],"enrichment":{"headline":"Phase 2: testing GAL-101 for Geographic Atrophy of the Macula","inPlainEnglish":"Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina.","whoItsFor":["Ages 55 Years to any","Willing and able to comply with the study schedule and study assessments","Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution","BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline","Refractive error between +3 and -6 diopters spherical equivalent in the study eye","Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline","Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center","Well-delineated cumulative GA area between 1.25 and 12.0 mm2"],"whoShouldSkip":["Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline","History of laser therapy in the macular region, regardless of indication","History of herpes zoster","Ophthalmic disease or condition that requires or is likely to require surgery during the study period","GA with cumulative area \\<1.25 mm2","Any GA lesion within 100 µm radius from the center point of the fovea","Axial length \\>26 mm"],"whatHappens":"If you join, the listed intervention(s) are GAL-101, or Placebo. The registry lists allocation as randomized. Age-related macular degeneration (AMD) affects millions of elderly patients.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 110 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.136Z"},{"nctId":"NCT06661564","title":"Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study","officialTitle":"Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Tours","sponsorClass":"OTHER","summary":"The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.\n\nHuman tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. Advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. Total tau has been reported as elevated in the tears of patients with AD compared to controls (n=65). Additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. This supports the relevance of comparing both AD proteins biomarkers and metabo-lipidomic signatures in the tears of patients with AD (Mild Cognitive Impairement (MCI) and dementia) with healthy controls.","conditions":["Alzheimer Disease"],"keywords":["biomarkers","tears","metabolomic","lipidomic","Alzheimer disease"],"interventions":[{"type":"OTHER","name":"Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42)"},{"type":"OTHER","name":"Collection of a blood sample (5 mL) for blood biomarkers analysis"}],"enrollment":90,"startDate":"2025-07-09","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Participant affiliated in French Social Security scheme\n* Informed and written consent from the participant\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman\n* Participant under judicial protection measures\n* Participant under guardianship or curatorship\n* Contraindications to participation in the research:\n\nOther neurodegenerative disease Any eye drops or treatment that may interfere with tear production Occasional or permanent contact lens use within the last 3 months Eye surgery ≤3 months Any ocular pathology other than refractive errors, oculomotor disorders, amblyopia Any general pathology other than AD with ocular implications\n\n-Inability to perform tear collection","locations":[{"facility":"CHRU de Tours","city":"Tours","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Victoire LEROY, MD","phone":"0247477693","email":"victoire.leroy@univ-tours.fr"},{"name":"Raoul Kanav KHANNA, MD, PhD","phone":"","email":"raoul.khanna@univ-tours.fr"}],"primaryOutcomes":["Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers","Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers","Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers","Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers","Lipids in basal tears of patients with AD vs healthy volunteers","Metabolites in basal tears of patients with AD vs healthy volunteers"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["tours-france"],"enrichment":{"headline":"Not a traditional drug phase: Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42) for Alzheimer Disease","inPlainEnglish":"The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.","whoItsFor":["Ages 18 Years to any","Participant affiliated in French Social Security scheme","Informed and written consent from the participant"],"whoShouldSkip":["Pregnant or breastfeeding woman","Participant under judicial protection measures","Participant under guardianship or curatorship","Contraindications to participation in the research:","Inability to perform tear collection"],"whatHappens":"If you join, the listed intervention(s) are Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42), or Collection of a blood sample (5 mL) for blood biomarkers analysis. The registry lists allocation as randomized. The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Tours. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.330Z"},{"nctId":"NCT06661720","title":"Testing the Addition of the Anti-Cancer Drug Tivozanib to Immunotherapy (Pembrolizumab) After Surgery to Remove All Known Sites of Kidney Cancer","officialTitle":"Short TeRm Intensified Pembrolizumab (KEytruda) and Tivozanib for High-Risk Renal Cell Carcinoma - STRIKE","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alliance for Clinical Trials in Oncology","sponsorClass":"OTHER","summary":"This phase III trial compares the effect of adding tivozanib to standard therapy pembrolizumab versus pembrolizumab alone for the treatment of patients with high-risk renal cell carcinoma (RCC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tivozanib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals tumor cells to multiply. This helps stop the spread of tumor cells. Giving pembrolizumab and tivozanib together may work better than pembrolizumab alone in treating patients with RCC.","conditions":["Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma (RCC)","Stage II Renal Pelvis Cancer AJCC v8","Stage III Renal Pelvis Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Tivozanib"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"MRI"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Biopsy"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":1040,"startDate":"2025-03-14","completionDate":"2037-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* • Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy)\n\n  * Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted\n\n    * Intermediate-high risk RCC:\n\n      * pT2 grade 4 or sarcomatoid features, N0M0\n      * pT3 any grade N0, M0\n    * High-risk RCC\n\n      * pT4, any grade, N0, M0\n      * pT, any stage., any grade, N+, M0\n    * cM1 no evidence of disease (NED) RCC\n\n      * Participants who have had resection of primary tumor (radical or partial nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous)\n\n        * Surgery (radical or partial nephrectomy or metastasectomy or ablation) \\> 4 weeks but =\\< 16 weeks prior to study registration with no ongoing complications from surgery\n        * No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis\n        * No prior systemic treatment for RCC\n        * Age \\>= 18 years\n        * Eastern Cooperative Oncology Group (ECOG) performance status =\\< 2 (or Karnofsky \\>= 60%)\n        * Absolute neutrophil count (ANC) \\>= 1,000/mm\\^3\n        * Platelet count \\>= 100,000/mm\\^3\n        * Hemoglobin \\>= 8 g/dL\n        * Total bilirubin =\\< 3 x upper limit of normal (ULN)\n        * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\< 3 x upper limit of normal (ULN)\n        * Calculated (calc.) creatinine clearance \\>= 30 mL/min (using Cockcroft Gault equation or the estimated glomerular filtration rate from the modification of diet in renal disease trial)\n        * Urine protein =\\< 1+ on urine analysis (UA) or urine protein creatinine ration (UPCR) \\< 2mg/mg\n        * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test is required =\\< 14 days prior to registration\n        * HIV status: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n        * Hepatitis\n  * Hepatitis B: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with resolved HBV infection, defined as positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antigen (HbsAg), are eligible\n  * Hepatitis C: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n\n    * Cardiac Disease: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class IIB or better\n    * No history of myocarditis\n    * No history of clinically significant pneumonitis\n    * No uncontrolled hypertension (systolic blood pressure \\[BP\\] \\> 150 mm Hg or diastolic BP \\> 90 mm Hg) documented on 2 consecutive measurements taken at least 2 hours apart\n    * No serious non-healing wound, ulcer or bone fracture within 28 days prior to registration\n    * No serious/active infection requiring parenteral antibiotics\n    * No moderate or severe hepatic impairment (child-Pugh B or C)\n    * No significant bleeding disorders within 1 month prior to registration, for example:\n  * Hematemesis, hematochezia or other gastrointestinal bleeding grade 3 or higher\n  * Hemoptysis of pulmonary bleeding grade 3 or higher\n  * Hematuria or other genitourinary bleeding grade 3 or higher\n\n    * No history of allogeneic organ transplantation\n    * No history of allergy of hypersensitivity to study drugs or components\n    * No condition requiring systemic treatment with either corticosteroid (\\> 10 mg daily or prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids and adrenal replacement doses ≤10 mg daily prednisone equivalent are permitted in absence of active autoimmune disease\n    * No active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition associated with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 4 weeks prior to registration\n    * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n    * No patients with a history of autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids \\> 10 mg/day, or immunosuppressive drugs) with the following exceptions:\n  * Replacement therapy (e.g., thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n  * Brief (\\<7 days) use of systemic corticosteroids is allowed when use is considered standard of care\n  * Patients with vitiligo, psoriasis, type 1 diabetes mellitus, hypothyroidism, or resolved childhood asthma/atopy will not be excluded\n  * Patients requiring intermittent use of bronchodilators, inhaled steroids, or local steroid injections will not be excluded\n  * Patients with hypothyroidism that is stable with hormone replacement or Sjögren's syndrome will not be excluded • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment","locations":[{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Auburn Faith Hospital","city":"Auburn","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Antelope Valley","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA / Jonsson Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Medical Center","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Oncology/Hematology-Newport Beach","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation Health Care","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Roseville Medical Center","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Medical Center Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Medical Center - 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Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.996Z"},{"nctId":"NCT06663332","title":"A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants","officialTitle":"CNTO1959ISD3001: A Phase 3, Multicenter, Open-label, Basket, Long-term Extension Study to Evaluate the Safety of Guselkumab in Pediatric Participants With Crohn's Disease, Ulcerative Colitis, or Juvenile Psoriatic Arthritis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).","conditions":["Crohns Disease","Colitis, Ulcerative","Arthritis, Psoriatic","Arthritis, Juvenile"],"keywords":[],"interventions":[{"type":"DRUG","name":"Guselkumab"}],"enrollment":196,"startDate":"2024-10-29","completionDate":"2031-12-12","sex":"ALL","minAge":"3 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have completed the dosing planned in the primary pediatric guselkumab study\n* Must have received benefit from continued guselkumab therapy in the opinion of the investigator\n* Before enrollment, a participant must be either: (a) Not of childbearing potential, OR (b) Of childbearing potential and not sexually active, practicing abstinence or a highly effective method of contraception and agrees to remain on a highly effective method while receiving study intervention and until 12 weeks after the last dose - the end of relevant systemic exposure\n* Parent(s) (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to allow the child to participate in the study. Assent is required from participants who are capable of understanding the nature of the study, typically those aged 7 years and older, to ensure their willingness to participate. An adolescent who provides assent will have the opportunity to sign an adult ICF upon reaching the age of majority, thereby affirming their understanding of the study's purpose and procedures, as well as their willingness to participate.\n\nExclusion Criteria:\n\n* Participant is greater than or equal to (\\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication\n* Participant is \\<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication\n* Are pregnant, nursing, or planning pregnancy or fathering a child\n* Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention\n* Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments","locations":[{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Center for Digestive Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cook Childrens Medical Center","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Caici","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Kids Research Institute Australia on behalf of the Centre for Child Health Research","city":"Nedlands","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Hospital Brisbane Inflammatory Bowel Diseases","city":"South Brisbane","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital at Westmead","city":"Westmead","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel","city":"Jette","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clinicas - UFG","city":"Goiânia","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"INTEGRAL Pesquisa e Ensino","city":"Votuporanga","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Capital Center For Children's health Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhou No 2 Peoples Hospital","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Childrens Hospital Zhejiang University School Of Medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital Zhejiang University School of Medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital Shanghai Jiao Tong University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengjing Hospital Of China Medical University","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Center University De Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Schon Klinik Hamburg Eilbek","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Klinik Sankt Augustin","city":"Sankt Augustin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Ein-Qarem Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Papa Giovanni XXIII Bergamo","city":"Bergamo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda USL di Bologna - Ospedale Maggiore","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale Pediatrico Bambino Gesu","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Casa Sollievo Della Sofferenza IRCCS","city":"San Giovanni Rotondo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Materno Infantile Burlo Garofolo","city":"Trieste","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Children's Medical Center","city":"Fuchū","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kanazawa University Hospital","city":"Kanazawa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe University Hospital","city":"Kobe","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Kumamoto Hospital","city":"Kumamoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shinshu University Hospital","city":"Matsumoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saga University Hospital","city":"Saga","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama City University Medical Center","city":"Yokohama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Akershus Universitetssykehus","city":"Akershus","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korczowski Bartosz Gabinet Lekarski","city":"Rzeszów","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdrowia Dziecka i Rodziny im Jana Pawla II w Sosnowcu Sp z o o","city":"Sosnowiec","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Network","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instytut Pomnik Centrum Zdrowia Dziecka","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uls Braga - Hosp. Braga","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uls Sao Joao - Hosp. Sao Joao","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Clinico Univ. de Santiago","city":"Santiago de Compostela","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. I Politecni La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gazi University Medical Faculty","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Umraniye Training and Research Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kocaeli Universitesi Hastanesi","city":"Kocaeli","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Stoke University Hospital","city":"Stoke-on-Trent","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haywood Hospital","city":"Stoke-on-Trent","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Participants with Treatment-Emergent Adverse Events as Assessment of Safety"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","indianapolis-indiana","cincinnati-ohio","fort-worth-texas","salt-lake-city-utah","rosario-argentina","nedlands-australia","south-brisbane-australia","westmead-australia","jette-belgium","leuven-belgium","goi-nia-brazil","votuporanga-brazil","beijing-china","changzhou-china","hangzhou-china","shanghai-china","shenyang-china","lille-france","hamburg-germany","sankt-augustin-germany","jerusalem-israel","bergamo-italy","bologna-italy","roma-italy","san-giovanni-rotondo-italy","trieste-italy","fuch-japan","kanazawa-japan","kobe-japan","kumamoto-japan","matsumoto-japan","saga-japan","yokohama-japan","akershus-norway","rzesz-w-poland","sosnowiec-poland","warsaw-poland","braga-portugal","porto-portugal","seoul-south-korea","santiago-de-compostela-spain","valencia-spain","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","kocaeli-turkey-t-rkiye","sheffield-united-kingdom","stoke-on-trent-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Guselkumab for Crohns Disease","inPlainEnglish":"This study wants to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).","whoItsFor":["Ages 3 Years to any","Must have completed the dosing planned in the primary pediatric guselkumab study","Must have received benefit from continued guselkumab therapy in the opinion of the investigator"],"whoShouldSkip":["Participant is greater than or equal to (\\>=) 18 years of age and resides in a country where 2 years have elapsed post marketing authorization for the respective adult indication","Participant is \\<18 years of age and resides in a county where 2 years have elapsed post marketing authorization for the respective pediatric indication","Are pregnant, nursing, or planning pregnancy or fathering a child","Have taken any disallowed therapies before the planned first long-term extension (LTE) dose of study intervention","Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator","Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments"],"whatHappens":"If you join, the listed intervention(s) are Guselkumab. The registry lists allocation as randomized. This study wants to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 196 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.576Z"},{"nctId":"NCT06665997","title":"Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease","officialTitle":"Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease.\n\nParticipants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain. They will complete a 3-month \"baseline \"with no use of hormonal contraception, and then a 3-month follow-up after receiving an injection of Depo-Provera. Participants will complete 6 to 7 in-person visits with a urine pregnancy test, blood draw, and surveys, as well as complete remote weekly surveys and monthly home pregnancy tests.","conditions":["Sickle Cell Disease (SCD)","Vaso-Occlusive Pain Episode in Sickle Cell Disease"],"keywords":["Sickle Cell Disease","Depot Medroxyprogesterone Acetate (Depo-Provera)","Contraception","Vaso-Occlusive Pain"],"interventions":[{"type":"DRUG","name":"Depot medroxyprogesterone acetate (DMPA)"}],"enrollment":65,"startDate":"2025-06-26","completionDate":"2028-07-31","sex":"FEMALE","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Female, aged 18-50 years old\n3. Diagnosis of sickle cell disease (SS, SB0,SB+,SC)\n4. Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months\n5. At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe\n6. Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study.\n7. Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days.\n8. Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months\n9. Access to a device with text-messaging capability\n10. Must be able to read and understand English\n11. Willing to comply with study procedures\n\nExclusion Criteria:\n\n1. Chronic inflammatory conditions, such as lupus or inflammatory bowel disease\n2. History of VTE or stroke\n3. Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation\n4. Current use of hormonal contraception or the copper intrauterine device\n5. Current pregnancy or pregnancy within the last 6 months\n6. Current lactation\n7. Polycystic ovary syndrome or irregular periods\n8. Blood pressure \\>= 160 systolic or \\>=100 diastolic at screening visit\n9. Has a history or current evidence of any condition, therapy, or other circumstance that in the opinion of the investigator exposes the participant to risk through participating in the trial, may confound the results of the trial, or could interfere with participation for the full duration of the trial.","locations":[{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arden McAllister, MPH","phone":"267-785-8044","email":"arden.mcallister@pennmedicine.upenn.edu"}],"primaryOutcomes":["Frequency of acute vaso-occlusive episodes"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","philadelphia-pennsylvania"],"enrichment":{"headline":"Phase 4: testing Depot medroxyprogesterone acetate (DMPA) for Sickle Cell Disease (SCD)","inPlainEnglish":"This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease. Participants in this study will be adult women with sickle cell disease who regularly experience sickle cell pain.","whoItsFor":["Ages 18 Years to 50 Years","Women only","Female, aged 18-50 years old","Diagnosis of sickle cell disease (SS, SB0,SB+,SC)","Report of at least 1 vaso-occlusive pain episode per month on average in the previous 6 months","At least 1 and no more than 10 medical presentations (e.g. hospitalization, emergencyroom visit, outpatient infusion visit) for vaso-occlusive pain during the past year, unless approved by study PI Andrea Roe","Willing to discontinue any hormonal contraception at the time of enrollment. Washout period of 1 month since last use of all hormonal contraception, and 4 months since most recent administration of depot medroxyprogesterone, is required prior to enrollment in the study","Have regular menstrual cycles (when not on hormonal contraception) with a usual length of 21 to 35 days","Stable dose of hydroxyurea and other sickle cell-related medications for the past 6 months"],"whoShouldSkip":["Chronic inflammatory conditions, such as lupus or inflammatory bowel disease","History of VTE or stroke","Current use of crizanlizumab, voxelotor, or chronic transfusion therapy, including simple transfusion and red cell exchange transfusion, history of hematopoietic stem cell transplantation","Current use of hormonal contraception or the copper intrauterine device","Current pregnancy or pregnancy within the last 6 months","Polycystic ovary syndrome or irregular periods","Blood pressure \\>= 160 systolic or \\>=100 diastolic at screening visit"],"whatHappens":"If you join, the listed intervention(s) are Depot medroxyprogesterone acetate (DMPA). The registry lists allocation as na. This research is being conducted to see if using an injectable contraception, Depot Medroxyprogesterone Acetate (Depo-Provera), can reduce the pain experienced by women with sickle cell disease.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 65 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.834Z"},{"nctId":"NCT06668389","title":"Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial","officialTitle":"Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial (STEPS Trial)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The University of Hong Kong","sponsorClass":"OTHER","summary":"Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood. One sequalae that nearly all rTOF patients develop during their lifetime is significant pulmonary regurgitation. Pulmonary regurgitation causes progressive right ventricular dilatation and systolic dysfunction, which in turn impairs cardio-pulmonary function and overall survival.\n\nThere is currently no pharmacological therapy proven to improve cardio-pulmonary function in rTOF patients. In a double-blind, placebo controlled, randomized controlled trial involving 33 rTOF patients, the use of beta-adrenergic receptor blocker Bisoprolol failed to improve maximal oxygen uptake (VO2 max) in the treatment group. Furthermore, there was no significant change in dimension of right ventricle on cardiac imaging, or heart failure biomarkers including brain natriuretic peptide (BNP) and atrial natriuretic peptide (ANP). In the APPROPRIATE trial involving 64 patients, angiotensin-converting-enzyme inhibitor (ACEI) Ramipril similarly failed to improve VO2 max despite an improved right ventricular long-axis shortening. In REDEFINE trial, 95 rTOF patients were randomized in to receive angiotensin receptor blocker (ARB) Losartan and control. At the end of study, there was no significant difference between the two groups in VO2 max, right ventricular ejection fraction, and other key outcomes.\n\nSodium-glucose cotransporter 2 (SGLT2) inhibitor is a promising therapy for rTOF patients. Clinical trials consistently demonstrated that SGLT2 inhibitors reduce heart failure hospitalization and mortality among patients with heart failure with or without diabetes mellitus. There have been growing body of evidence that demonstrate that SGLT2 inhibitors improve right ventricular function. In a preclinical study of rat with pulmonary hypertension induced right ventricular failure, empagliflozin was found to reduce pulmonary pressure, alleviate right ventricular hypertrophy and reduce myocardial fibrosis. In a pilot study involving 10 patients with adult congenital heart disease and systemic right ventricular failure, SGLT2 inhibitors improved cardio-pulmonary function as reflected by 6-minute walk test performance and New York Heart Association functional status. Most recently, investigators from DAPA-SERVE randomized controlled trial reported that among 92 patients with systemic right ventricular failure, those randomized to receive SGLT2 inhibitors had superior systemic right ventricular function with larger fractional area change (FAC) and more negative free-wall global longitudinal strain. Nevertheless, as these trials involve patients with right ventricular connections to the systemic circulation rather than pulmonary circulation in rTOF, it is uncertain whether the trial results can be extrapolated to the rTOF population. The critical knowledge gap our proposed randomized controlled trial seeks to address is whether SGLT2 inhibitors improve cardio-pulmonary function in rTOF patients.","conditions":["Congenital Heart Disease","Repaired Tetralogy of Fallot (rTOF)","Pulmonary Regurgitation","Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor","Dapagliflozin (Forxiga)"],"keywords":["Congenital Heart Disease","Repaired Tetralogy of Fallot (rTOF)","Pulmonary Regurgitation","Sodium-glucose cotransporter 2 (SGLT2) inhibitor","Dapagliflozin (Forxiga)"],"interventions":[{"type":"DRUG","name":"SGLT2 inhibitor (Dapagliflozin 10mg)"}],"enrollment":106,"startDate":"2025-05-12","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* rTOF\n* Aged 18 years or above\n* Voluntarily agrees to participate in the clinical trial and provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure with reduced ejection fraction (HFrEF) with LVEF \\< 40%\n* Planned cardiac and/or non-cardiac surgery in 3 months\n* Chronic kidney disease stages 4 to 5\n* Unable to perform cardiopulmonary test\n* Recent use of SGLT2 inhibitors within 6 months\n* Known hypersensitivity to SGLT2 inhibitors\n* History of diabetic ketoacidosis\n* Recent symptomatic hypoglycaemia within 6 months\n* Insulin dependent diabetes mellitus\n* History of perineum infection\n* Recent urinary tract infection within 6 months\n* Recent genital infection within 6 months\n* Other known contraindication to SGLT2 inhibitor\n* Pregnancy or breast feeding","locations":[{"facility":"Department of Medicine, Queen Mary Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chun Ka Dr Wong, Clinical Assistant Professor","phone":"+852-22553111","email":"wongeck@hku.hk"}],"primaryOutcomes":["Maximal oxygen uptake (VO2 max) on cardiopulmonary exercise (CPX) at 3 months"],"hasResults":false,"conditionSlugs":["als","heart-failure","hypertension"],"drugSlugs":["empagliflozin","dapagliflozin"],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Phase 4: testing SGLT2 inhibitor (Dapagliflozin 10mg) for Congenital Heart Disease","inPlainEnglish":"Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease. With advances in open-heart surgical repair techniques and medical therapies, there is a significant increase in patients with rTOF surviving till late adulthood.","whoItsFor":["Ages 18 Years to any","Aged 18 years or above"],"whoShouldSkip":["Heart failure with reduced ejection fraction (HFrEF) with LVEF \\< 40%","Planned cardiac and/or non-cardiac surgery in 3 months","Chronic kidney disease stages 4 to 5","Unable to perform cardiopulmonary test","Recent use of SGLT2 inhibitors within 6 months","Known hypersensitivity to SGLT2 inhibitors","History of diabetic ketoacidosis"],"whatHappens":"If you join, the listed intervention(s) are SGLT2 inhibitor (Dapagliflozin 10mg). The registry lists allocation as randomized. Repaired Tetralogy of Fallot (rTOF) is the leading cause of congenital cyanotic heart disease worldwide, involving up to 7-10% of congenital heart disease.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 106 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.951Z"},{"nctId":"NCT06668571","title":"Intravenous Ketamine for Treatment-Resistant Depression","officialTitle":"Central and Peripheral GABA and Glutamate Modulation With Intravenous Ketamine for Treatment-Resistant Depression (G2K): A Randomized, Double-Blind, Placebo-Controlled Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"The purpose of this study is to to evaluate the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.","conditions":["Depressive Disorder, Treatment-Resistant","Treatment Resistant Depression (TRD)"],"keywords":["Major Depression","Depressive Disorder, Treatment-Resistant","MDD","TRD","Treatment-Resistant Depression","Treatment-Resistant Major Depression","Ketamine","Intravenous Ketamine"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"DRUG","name":"Normal Saline"}],"enrollment":30,"startDate":"2025-02-10","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to provide informed consent\n* Meets diagnostic criteria for major depressive disorder without psychotic features per the SCID DSM-IV-TR\n* PHQ-9 total score ≥ 15 at screening\n* Treatment-resistant depression, as defined by failure of at least two previous antidepressant treatments within the current depressive episode. Failed antidepressant treatments can include pharmacotherapy for depression at an adequate dose for at least 8 weeks, trial of transcranial magnetic stimulation (TMS) or an acute series of at least 6 administrations of electroconvulsive therapy (ECT)\n* Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria\n\nExclusion Criteria:\n\n* Inability to speak English\n* Inability to provide consent or have a legal guardian\n* Patients with a BMI \\> 40 kg/m2.\n* Personality disorder being the primary diagnosis\n* Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or active psychotic symptoms\n* Active post-traumatic stress disorder symptoms based on clinical assessment\n* Ongoing prescription of \\> 2 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment\n* Medications known to affect glutamate (i.e., Riluzole, Carbamazepine) or GABA (zaleplon, zolpidem, zopiclone, Valproate, Gabapentin, Pregabalin, tiagabine, and vigabatrin) are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug\n* Monoamine Oxidase Inhibitors (MAOIs) are prohibited two weeks prior to administration of study drug\n* Opioid antagonists (naltrexone, naloxone, nalmefene, methylnaltrexone, buprenorphine and naloxone combination) are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug\n* CYP3A4 inducers carbamazepine and modafinil are prohibited within two weeks prior to administration of study drug and at least 24 hours after last dose of study drug.\n* Currently undergoing TMS, vagal nerve stimulation, or deep brain stimulation as either an acute or maintenance treatment of depression\n* ECT in the past 6 months\n* Any active or unstable medical condition judged by the study psychiatrist as conferring too great a level of medical risk to allow inclusion in the study\n* A history of bleeding in the brain\n* Arteriovenous malformation or a history of aneurysm\n* Use of methamphetamine, cocaine, or cannabis. Abuse of stimulant (s) within the prior 12 months\n* Any current substance use disorder (excluding nicotine and caffeine). Note: Persons will be allowed to enroll in this study if their substance use is in complete (not partial) and sustained (\\&gt; 1 year) remission\n* History of traumatic brain injury that resulted in loss of consciousness with brain bleeding\n* History of tonic-clonic (grand mal) seizures\n* Developmental delay, intellectual disability, or intellectual disorder\n* Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical diagnosis within the prior 12 months\n* Minor or Major Neurocognitive disorder\n* Received ketamine treatment for depression within the prior 2 months\n* History of either poor antidepressive response to or poor tolerability of ketamine (any route of administration) when previously administered\n* History of hypothyroidism unless taking a stable dose of thyroid medication and asymptomatic for 3 months\n* Hepatic insufficiency (2.5 X ULN for AST or ALT) within 3 months of consent, past liver transplant recipient, and/or clinical diagnosis of cirrhosis of the liver\n* Gastroesophageal reflux disease that is poorly managed\n* A diagnosis of Complex Regional Pain Syndrome (CRPS)\n* Pregnancy, or nursing\n* History of claustrophobia with active symptoms that would interfere with the MRI\n* Any contraindication to MRI safety questionnaire\n* Poorly controlled hypertension.","locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicole Reinicke","phone":"507-422-1835","email":"reinicke.nicole@mayo.edu"}],"primaryOutcomes":["Peak (% change from baseline) Anterior Cingulate Cortex metabolites (Gamma-Aminobutyric Acid and Glutamate)","Change in peripheral Gamma-Aminobutyric Acid and Glutamate levels","Change in the Montgomery Asberg Depression Rating Scale","Correlation between the percent change in central (anterior cingulate cortex) Gamma-Aminobutyric Acid and Glutamate levels and the change in depression severity measured using the Montgomery-Åsberg Depression Rating Scale","Correlation between the percent change in serum Gamma-Aminobutyric Acid and Glutamate levels and the change in depression severity measured using the Montgomery-Åsberg Depression Rating Scale"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Phase 2: testing Ketamine for Depressive Disorder, Treatment-Resistant","inPlainEnglish":"This study wants to to measure the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.","whoItsFor":["Ages 18 Years to 65 Years","Meets diagnostic criteria for major depressive disorder without psychotic features per the SCID DSM-IV-TR","PHQ-9 total score ≥ 15 at screening","Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria"],"whoShouldSkip":["Inability to provide consent or have a legal guardian","Patients with a body-mass index (BMI) \\> 40 kg/m2","Personality disorder being the primary diagnosis","Diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or active psychotic symptoms","Active post-traumatic stress disorder symptoms based on clinical assessment","Ongoing prescription of \\> 2 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment","Monoamine Oxidase Inhibitors (MAOIs) are prohibited two weeks prior to administration of study drug"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Normal Saline. The registry lists allocation as randomized. This study wants to to measure the relationships between peak (% change from baseline) central GABA and Glu levels during a 40-min IV ketamine or normal saline infusion utilizing fMRS, and change in peripheral GABA and Glu levels from baseline to 24-hr postinfusion utilizing LCMS, with baseline to 24-hr post-infusion change in depression (MADRS) in 30 TRD adults.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Rochester. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.787Z"},{"nctId":"NCT06668922","title":"Irritable Bowel Syndrome and Control Volunteers: Diet Challenge","officialTitle":"Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, Los Angeles","sponsorClass":"OTHER","summary":"The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms. Primary aims include: (a) identifying GI microbiome signatures in IBS subtypes (IBS-C and IBS-D) and matched controls, and test if microbiome signatures in these groups correlate with fecal SCFAs and bacterial fermentation of an indigestible carbohydrate (inulin) after a dietary challenge (fecal inulin), and (b) determining if GI microbiome signatures in IBS subtypes and controls correlate with fecal BAs or markers of SCFA production (fecal SCFAs or inulin) and test if BAs correlate with fecal SCFAs or inulin.\n\nThe target population is adults ages 18-65 years meeting Rome IV criteria for IBS (both diarrhea- and constipation-predominant, IBS-D and IBS-C) and asymptomatic controls. Primary outcomes will be fecal bile acid excretion and profile, short-chain fatty acid excretion and profile, colonic transit, and fecal microbiota. Secondary outcomes will be stool characteristics based on responses to validated bowel diaries. Stool samples will be collected from participants during the last 2 days of a 4-day 100 g fat diet and split into 3 samples for fecal microbiota, SCFA, and bile acid analysis.","conditions":["Irritable Bowel Syndrome (IBS)"],"keywords":["irritable bowel syndrome","IBS","short-chain fatty acids","SCFAs","bile acids","fecal inulin","microbiota"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Inulin"}],"enrollment":72,"startDate":"2024-11-28","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-75\n* Individuals with irritable bowel syndrome (IBS)\n* Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms\n* No dietary restrictions other than vegetarian\n\nExclusion Criteria:\n\n* Inflammatory bowel disease, celiac disease, or certain types of abdominal cancer, as well as those with thyroid or liver issues\n* Abdominal surgery or abdominal radiation within 6 months of study participation, with an exception for C-section or gallbladder removal\n* Use of any prescription, over the counter, or herbal medications known to affect gastrointestinal function or study interpretation, such as opioids, inflammatory drugs or certain antidepressants, within 6 months prior to study participation for healthy volunteers, or within 2 days of study participation for participants with IBS.\n* An exception will be permitted for limited use of stable low doses of antidepressants for individuals who have been taking them for a period greater than one month.\n* Rescue medication such as Bisacodyl (dulcolax) to relieve severe constipation and allow for stool collection will be permitted when needed.\n* Use of Ozempic and Ozempic-type medications\n* Pregnant or breastfeeding women\n* Antibiotic use within 3 months of study participation\n* Use of prebiotics or probiotics within the 2 weeks before the study initiation\n* Regular tobacco use within the past 6 months","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Total fecal bile acids","Total fecal short chain fatty acids","Individual fecal short chain fatty acids","Fecal microbial population","Fecal inulin"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: Inulin for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS). The central hypothesis of this study is that specific shifts in the GI microbiome composition correlate with altered colonic SCFAs and BAs and contribute to IBS symptoms.","whoItsFor":["Ages 18 Years to 75 Years","Individuals with irritable bowel syndrome (IBS)","Healthy volunteers (healthy controls) with no prior history of gastrointestinal (GI) disease or symptoms","No dietary restrictions other than vegetarian"],"whoShouldSkip":["Inflammatory bowel disease, celiac disease, or certain types of abdominal cancer, as well as those with thyroid or liver issues","Abdominal surgery or abdominal radiation within 6 months of study participation, with an exception for C-section or gallbladder removal","An exception will be permitted for limited use of stable low doses of antidepressants for individuals who have been taking them for a period greater than one month","Rescue medication such as Bisacodyl (dulcolax) to relieve severe constipation and allow for stool collection will be permitted when needed","Use of Ozempic and Ozempic-type medications","Pregnant or breastfeeding women","Antibiotic use within 3 months of study participation"],"whatHappens":"If you join, the listed intervention(s) are Inulin. The registry lists allocation as randomized. The study will investigate the relationship between fecal bile acids, short-chain fatty acids (SCFAs), and the gut microbiota in irritable bowel syndrome (IBS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at Los Angeles. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.441Z"},{"nctId":"NCT06671483","title":"A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines","officialTitle":"A Multi-Center, Randomized, Double-Blind, Placebo- and Active-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who Are Naïve to Biologic Disease-Modifying Antirheumatic Drugs (LATITUDE-PsA-3001)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).\n\nThe main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.\n\nThe participants will be treated with either zasocitinib, active comparator, or placebo. Participants will be in the study for up to 60 weeks.","conditions":["Psoriatic Arthritis"],"keywords":["Drug Therapy","Latitude Research Program","Latitude PsA","Latitude PsA-3001"],"interventions":[{"type":"DRUG","name":"Zasocitinib"},{"type":"DRUG","name":"Active Comparator"},{"type":"DRUG","name":"Placebo"}],"enrollment":1088,"startDate":"2025-03-03","completionDate":"2027-05-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAge:\n\n1. The participant is aged 18 years or older at the time of signing the informed consent form (ICF). In South Korea, the age requirement for adult participants is \\>=19 years of age.\n\n   Disease Characteristics:\n2. The participant has a diagnosis of PsA.\n3. The participant must have signs and symptoms of PsA for at least 3 months prior to screening.\n4. The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria).\n5. The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits.\n6. The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO.\n\n   Medications for PsA:\n7. The participant has had at least one of the following:\n\n   1. Inadequate response to a nonsteroidal anti-inflammatory drug (NSAID) (not applicable in the European Union \\[EU\\]/ European Economic Area \\[EEA\\]), OR\n   2. Inadequate response to a conventional synthetic disease-modifying antirheumatic drug (csDMARD).\n\nExclusion Criteria:\n\nPsA and PsO:\n\n1. The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia.\n2. The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO).","locations":[{"facility":"AARR- Chandler AZ","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Arthritis & Rheumatology Research, PLLC | Phoenix, AZ","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First OC Dermatology Research Inc.","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Purushotham & Akther Kotha MD","city":"La Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triwest Research Associates LLC","city":"La Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cohen Medical Centers","city":"Thousand Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Foothill Arthritis Clinic","city":"Tujunga","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medvin Clinical Research","city":"Whittier","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Denver Arthritis Clinic | Denver, CO","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis & Rheumatic Disease Specialties (AARDS)","city":"Aventura","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"RASF- Clinical Research Center","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida | Clearwater, FL","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GNP Research, LLC | Hollywood, FL","city":"Cooper City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Driven Research LLC","city":"Coral Gables","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Tectum Medical Research","city":"Davie","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sweet Hope Research Specialty, Inc, d/b/a Neoclinical Research","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partners","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HMD Research LLC","city":"Orlando","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Millennium Research | Ormond Beach, FL","city":"Ormond Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRIS Research and Development | Plantation, FL","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarasota Arthritis Research Center","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Broward Rheumatology Associates, Inc.","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida | Tampa, FL","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marietta Rheumatology Associates","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSCP/CIS","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Greater Chicago Specialty Physicians LLC/CIS","city":"Schaumburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research, Inc. | Lake Charles","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klein & Associates, M.D., P.A.","city":"Hagerstown","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health System-Rheumatology Department","city":"Detroit","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Michigan Rheumatology Group, P.C. - Grand Blanc Office","city":"Grand Blanc","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ash Research Clinic - Howell","city":"Howell","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"June DO, PC Private Practice - Dr. Justus Fiechtner","city":"Lansing","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute of Michigan","city":"Saint Clair Shores","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Louis Rheumatology","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albuquerque Center for Rheumatology PC","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Santa Fe Rheumatology","city":"Santa Fe","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health | Joseph S. and Diane H. 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Hospital de Sabadell","city":"Sabadell","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Santiago de Compostela | Building A - Rheumatology Department","city":"Santiago de Compostela","state":"Galicia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Malaga","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University","city":"Tainan","state":"Tainan City","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Zhong Zheng Qu","state":"Taipei City","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Far Eastern Memorial Hospital | Allergy, Immunology and Rheumatology Department","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chung Shan Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chi Mei Medical Center","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Takeda Contact","phone":"+1-877-825-3327","email":"medinfoUS@takeda.com"}],"primaryOutcomes":["Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 16 for Zasocitinib Dose A and B Compared to Placebo"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["chandler-arizona","phoenix-arizona","fountain-valley-california","la-mesa-california","thousand-oaks-california","tujunga-california","whittier-california","denver-colorado","aventura-florida","boca-raton-florida","clearwater-florida","cooper-city-florida","coral-gables-florida","davie-florida","hialeah-florida","miami-florida","orlando-florida","ormond-beach-florida","plantation-florida","sarasota-florida","tamarac-florida","tampa-florida","marietta-georgia","orland-park-illinois","schaumburg-illinois","lake-charles-louisiana","hagerstown-maryland","detroit-michigan","grand-blanc-michigan","howell-michigan","lansing-michigan","saint-clair-shores-michigan","st-louis-missouri","albuquerque-new-mexico","santa-fe-new-mexico","brooklyn-new-york","hickory-north-carolina","cleveland-ohio","middleburg-heights-ohio","wyomissing-pennsylvania","jackson-tennessee","baytown-texas","bellaire-texas","houston-texas","lubbock-texas","mesquite-texas","plano-texas","spokane-washington","anderlecht-belgium","ghent-belgium","genk-belgium","brussels-belgium","li-ge-belgium","sofia-bulgaria","pleven-bulgaria","plovdiv-bulgaria","rousse-bulgaria","stara-zagora-bulgaria","providencia-chile","santiago-chile","zagreb-croatia","osijek-croatia","rijeka-croatia","split-croatia","zadar-croatia","brno-czechia","hlu-n-czechia","prague-czechia","uhersk-hradi-t-czechia","ostrava-czechia","zl-n-czechia","pardubice-czechia","tallinn-estonia","tartu-estonia","bad-bentheim-germany","bad-doberan-germany","ratingen-germany","leipzig-germany","berlin-germany","dresden-germany","hamburg-germany","m-nchen-germany","h-dmez-v-s-rhely-hungary","szeged-hungary","sz-kesfeh-rv-r-hungary","budapest-hungary","veszpr-m-hungary","ashdod-israel","ashkelon-israel","haifa-israel","nahariya-israel","ramat-gan-israel","tel-aviv-israel","torrette-italy","rome-italy","milan-italy","rozzano-italy","padova-italy","florence-italy","pisa-italy","liep-ja-latvia","riga-latvia","mexicali-mexico","zapopan-mexico","guadalajara-mexico","gustavo-adolfo-madero-mexico","mexico-city-mexico","m-rida-mexico","chihuahua-city-mexico","christchurch-central-new-zealand","auckland-new-zealand","nelson-new-zealand","hamilton-new-zealand","poznan-poland","krakow-poland","katowice-poland","sochaczew-poland","warsaw-poland","opole-poland","bialystok-poland","bytom-poland","torun-poland","d-br-wka-poland","elblag-poland","olsztyn-poland","lodz-poland","nowa-s-l-poland","wroclaw-poland","coimbra-portugal","ponte-de-lima-portugal","vila-nova-de-gaia-portugal","almada-portugal","lisbon-portugal","caguas-puerto-rico","san-juan-puerto-rico","suwon-south-korea","seoul-south-korea","m-rida-spain","sabadell-spain","santiago-de-compostela-spain","m-laga-spain","seville-spain","valencia-spain","tainan-taiwan","zhong-zheng-qu-taiwan","new-taipei-city-taiwan","taichung-taiwan"],"enrichment":{"headline":"Phase 3: testing Zasocitinib for Psoriatic Arthritis","inPlainEnglish":"Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO). The main aim of the study is to know how well zasocitinib (TAK-279) works in participants with active PsA who have not previously been treated with biologic disease-modifying antirheumatic drugs.","whoItsFor":["Ages 18 Years to any","Disease Characteristics:","The participant has a diagnosis of PsA","The participant must have signs and symptoms of PsA for at least 3 months prior to screening","The participant meets the Classification Criteria for Psoriatic Arthritis (CASPAR criteria)","The participant has active arthritis as shown by a minimum of \\>=3 tender joints in TJC68 and \\>=3 swollen joints in SJC66 at the screening and baseline (Day 1) visits","The participant has at least 1 active lesion of plaque PsO \\>=2 cm in diameter, or any nail or nail bed changes characteristic of PsO","Medications for PsA:"],"whoShouldSkip":["The participant has other disease(s) that might confound the evaluations of benefit of zasocitinib therapy, including but not limited to rheumatoid arthritis, axial spondyloarthritis, systemic lupus erythematosus, Lyme disease, gout, or fibromyalgia","The participant has a concomitant comorbid skin condition that, in the opinion of the investigator, would interfere with the study assessments, such as evidence of non-plaque PsO (erythrodermic, pustular, predominately guttate PsO, inverse, or drug-induced PsO)"],"whatHappens":"If you join, the listed intervention(s) are Zasocitinib, Active Comparator, or Placebo. The registry lists allocation as randomized. Psoriatic arthritis (PsA) is a chronic inflammatory disease that affects the joints and skin in people who have psoriasis (PsO).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,088 people at 185 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.586Z"},{"nctId":"NCT06671886","title":"NAFLD Clinical Care Pathway","officialTitle":"Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.","conditions":["NAFLD","MASLD"],"keywords":["NAFLD","Veterans","Primary health care","MASLD"],"interventions":[{"type":"BEHAVIORAL","name":"E-trigger"}],"enrollment":32,"startDate":"2024-02-02","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPatient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center\n\nExclusion Criteria:\n\n* The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization\n* PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination\n* PACTs meeting the following criteria will be excluded from randomization in Aim 2:\n\n  * PACTs who do not treat NAFLD\n  * PACTs not located at the main hospital\n  * PACTs with less than 100 visits within 3 months","locations":[{"facility":"Michael E. DeBakey VA Medical Center, Houston, TX","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hashem B El-Serag, MD MPH","phone":"(713) 794-8640","email":"Hashem.El-Serag@va.gov"},{"name":"Kyler Godwin, PhD MPH BS","phone":"(713) 440-4672","email":"kyler.godwin@va.gov"}],"primaryOutcomes":["NAFLD Diagnosis and risk stratification"],"hasResults":false,"conditionSlugs":["liver-cancer","als","obesity"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: E-trigger for NAFLD","inPlainEnglish":"Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD.","whoItsFor":["Ages 18 Years to 80 Years","Patient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center"],"whoShouldSkip":["The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization","PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination","PACTs meeting the following criteria will be excluded from randomization in Aim 2:","PACTs who do not treat NAFLD","PACTs not located at the main hospital","PACTs with less than 100 visits within 3 months"],"whatHappens":"If you join, the listed intervention(s) are E-trigger. The registry lists allocation as randomized. Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 32 people at Houston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.144Z"},{"nctId":"NCT06672588","title":"Magnetic Seizure Therapy for Schizophrenia - Trial","officialTitle":"Magnetic Seizure Therapy for Schizophrenia - Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Centre for Addiction and Mental Health","sponsorClass":"OTHER","summary":"This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).","conditions":["Treatment Resistant Schizophrenia","Schizophrenia","Schizoaffective Disorder"],"keywords":["Schizophrenia","Schizoaffective Disorder","Treatment Resistant Schizophrenia","Electroconvulsive Therapy","Magnetic Seizure Therapy","Convulsive Therapy"],"interventions":[{"type":"DEVICE","name":"Magnetic Seizure Therapy (MST)"},{"type":"DEVICE","name":"Electroconvulsive Therapy (ECT)"}],"enrollment":80,"startDate":"2025-04-22","completionDate":"2028-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. are inpatients or outpatients;\n2. demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);\n3. have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);\n4. are 18 years of age or older;\n5. have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;\n6. have a BPRS score at baseline of at least moderate severity (\\&gt;4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;\n7. are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;\n8. are on an antipsychotic at an adequate dose and are agreeable to keeping their current antipsychotic treatment constant during the acute phase of the intervention;\n9. are able to adhere to the intervention schedule;\n10. meet the MST safety criteria;\n11. If a woman of child-bearing potential: is willing to provide a negative pregnancy test and agrees not to become pregnant during trial participation.\n\nExclusion Criteria:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;\n2. have received electroconvulsive therapy (ECT) in the past six (6) months;\n3. have a concomitant major unstable medical illness;\n4. are pregnant or intend to get pregnant during the study;\n5. have probable dementia based on study investigator assessment;\n6. have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;\n7. present with a serious medical condition,\n8. have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n9. require a benzodiazepine with a dose \\&gt; lorazepam 2 mg/day or equivalent or any anticonvulsant due to the potential of these medications to limit the efficacy of both MST and ECT;\n10. are unable to communicate in English fluently enough to complete the neuropsychological tests;\n11. have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).","locations":[{"facility":"University of British Columbia Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel Blumberger, MD., MSc.","phone":"416-535-8501","email":"daniel.blumberger@camh.ca"},{"name":"Hannah Taalman, MSc.","phone":"416-535-8501","email":"hannah.taalman@camh.ca"}],"primaryOutcomes":["Brief Psychiatric Rating Scale (BPRS) Response (18-Version)","MATRICS™ Consensus Cognitive Battery (MCCB)"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["vancouver-canada","toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: Magnetic Seizure Therapy (MST) for Treatment Resistant Schizophrenia","inPlainEnglish":"This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).","whoItsFor":["Ages 18 Years to any","are inpatients or outpatients;","demonstrate capacity to consent according to the MacArthur competence assessment tool for clinical research (MacCAT-CR);","have a DSM-5 diagnosis of Schizophrenia or Schizoaffective Disorder for at least 2 years, as determined by the MINI International Neuropsychiatric Interview - Version 7 (MINI-7.0);","are 18 years of age or older;","have demonstrated resistance to at least 2 antipsychotics of 600 mg of chlorpromazine equivalents for at least 6 weeks;","have a BPRS score at baseline of at least moderate severity (\\&gt;4) on one of the four psychotic items (i.e., hallucinatory behavior, suspiciousness, conceptual disorganization, unusual thought content) or at least 12 on these 4 items combined;","are considered to be appropriate to receive convulsive therapy as assessed by an ECT attending psychiatrist and a consultant anaesthesiologist;"],"whoShouldSkip":["have a history of MINI diagnosis of a substance use disorder (other than nicotine and caffeine) within the past three months;","have received electroconvulsive therapy (ECT) in the past six (6) months;","have a concomitant major unstable medical illness;","are pregnant or intend to get pregnant during the study;","have probable dementia based on study investigator assessment;","have any significant neurological disorder or condition likely to be associated with increased intracranial pressure or a space occupying brain lesion, e.g., cerebral aneurysm;","present with a serious medical condition,"],"whatHappens":"If you join, the listed intervention(s) are Magnetic Seizure Therapy (MST), or Electroconvulsive Therapy (ECT). The registry lists allocation as randomized. This trial aims to assess the clinical effects and tolerability of Magnetic Seizure Therapy (MST) as an alternative to electroconvulsive therapy (ECT) for Treatment Resistant Schizophrenia (RS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.043Z"},{"nctId":"NCT06675136","title":"Nab-Paclitaxel PIPAC in Combination With Paclitaxel and Ramucirumab for the Treatment of Stomach Cancer With Peritoneal Metastases","officialTitle":"Phase 1 Trial of Nab-Paclitaxel PIPAC (Pressurized Intraperitoneal Aerosolized Chemotherapy) Given in Combination With Second-Line Therapy for Gastric Cancer With Peritoneal Metastases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. PIPAC delivers chemotherapy, such as nab-paclitaxel, that has been turned into a fine mist (aerosolized) at a high pressure directly into the abdominal cavity. Aerosolized chemotherapy delivered directly into the peritoneal space has been shown to deliver higher drug concentrations to the tumor. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Giving nab-paclitaxel PIPAC in combination with paclitaxel and ramucirumab may be safe, tolerable, and/or effective in treating gastric cancer patients with peritoneal metastases.","conditions":["Clinical Stage IVB Gastric Cancer AJCC v8","Metastatic Gastric Adenocarcinoma","Metastatic Malignant Neoplasm in the Peritoneum"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"OTHER","name":"Medical Device Usage and Evaluation"},{"type":"DRUG","name":"Nab-paclitaxel"},{"type":"DRUG","name":"Paclitaxel"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"BIOLOGICAL","name":"Ramucirumab"}],"enrollment":30,"startDate":"2025-10-29","completionDate":"2029-01-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin \\[FOLFOX\\] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)\n\n  * Prior immunotherapy allowed\n  * Up to 4 cycles of second-line therapy allowed if no progression is documented\n* Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histologically or cytologically confirmed gastric adenocarcinoma\n* Visible peritoneal metastatic disease on cross-sectional imaging or diagnostic laparoscopy (does not have to be measurable by RECIST 1.1)\n* Fully recovered from acute toxic effects (except alopecia, hearing loss, or non-clinically significant laboratory abnormalities) ≤ grade 1 of prior anti-cancer therapy\n* The patient's urinary protein is ≤ 1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria ≥ 2+, then a 24-hour urine must be collected and must demonstrate \\< 1000mg protein in 24 hours\n* Complete medical history and physical exam (within 28 days prior to day 1 of protocol therapy)\n* Absolute neutrophil count (ANC) ≥ 1,500/mcL (within 28 days prior to day 1 of protocol therapy)\n* Platelets ≥ 100,000/mcL (within 28 days prior to day 1 of protocol therapy)\n* Hemoglobin ≥ 8 g/dL (within 28 days prior to day 1 of protocol therapy)\n* Serum albumin ≥ 2.8 g/dL (within 28 days prior to day 1 of protocol therapy)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease, then direct bilirubin \\< 1.5 mg/dL) (within 28 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) ≤ 5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* International normalized ratio (INR) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Prothrombin time (PT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Partial thromboplastin time (PTT) ≤ 1.5 x ULN (within 28 days prior to day 1 of protocol therapy)\n* Calculated creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula (within 28 days prior to day 1 of protocol therapy)\n* Seronegative for HIV antigen (Ag)/antibody (Ab) combo (within 28 days prior to day 1 of protocol therapy)\n\n  * If seropositive, patient may be eligible if they are stable on antiretroviral therapy, have a CD4 T cell count ≥ 200/µL, and have an undetectable viral load\n* Documented virology status of hepatitis, confirmed by hepatitis B virus (HBV) and hepatitis C virus (HCV) tests (within 28 days prior to day 1 of protocol therapy)\n\n  * For patients with active HBV, HBV deoxyribonucleic acid (DNA) \\< 500 IU/mL during screening, initiation of anti-HBV treatment at least 14 days prior to day 1 of cycle 1, and willingness to continue anti-HBV treatment during the study (per standard of care)\n  * If seropositive for HCV, nucleic acid quantification must be performed. Viral load must be undetectable\n* WOMEN OF CHILDBEARING POTENTIAL (WOCBP): Negative urine or serum pregnancy test (within 28 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control (e.g., licensed hormonal/barrier methods or surgery intended to prevent pregnancy \\[or with a side effect of pregnancy prevention\\]) or abstain from heterosexual activity for the course of the study through at least 14 months after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Intolerance to taxanes\n* Bowel obstruction requiring exclusive total parenteral nutrition\n* Any history of, or current, brain or subdural metastases\n* Life expectancy \\< 3 months\n* Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment\n\n  * Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved\n* Any prior malignancy except adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for two years\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (taxanes, etc.)\n* Clinically significant uncontrolled illness such as uncontrolled hypertension (HTN)\n* History of arterial thromboembolic events such as myocardial infarction (MI), cerebrovascular accident (CVA)\n* History of gastrointestinal (GI) perforation\n* FEMALES ONLY: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Dose-limiting toxicity (DLT)"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Nab-paclitaxel for Clinical Stage IVB Gastric Cancer AJCC v8","inPlainEnglish":"This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases). Paclitaxel is in a class of medications called antimicrotubule agents.","whoItsFor":["Ages 18 Years to any","Patients must have failed first-line systemic therapy (fluorouracil, leucovorin calcium, oxaliplatin \\[FOLFOX\\] with or without immunotherapy, or other fluoropyrimidine and platinum-based therapy)","Prior immunotherapy allowed","Up to 4 cycles of second-line therapy allowed if no progression is documented","Assent, when appropriate, will be obtained per institutional guidelines","Agreement to allow the use of archival tissue from diagnostic tumor biopsies","If unavailable, exceptions may be granted with study principal investigator (PI) approval","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"],"whoShouldSkip":["Intolerance to taxanes","Bowel obstruction requiring exclusive total parenteral nutrition","Any history of, or current, brain or subdural metastases","Life expectancy \\< 3 months","Treatment with therapeutic oral or IV antibiotics within 14 days prior to day 1 cycle 1 of treatment","Patients receiving prophylactic antibiotics are eligible, provided the signs of active infection have resolved","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agents (taxanes, etc.)"],"whatHappens":"If you join, the listed intervention(s) are Biopsy, Biospecimen Collection, or Computed Tomography. The registry lists allocation as na. This phase I trial tests the safety, side effects and best dose of nab-paclitaxel pressurized intraperitoneal aerosolized chemotherapy (PIPAC) in combination with second-line chemotherapy, paclitaxel and ramucirumab, and tests how well they work in treating stomach cancer that has spread from where it first started to the tissue that lines the abdominal wall and organs (peritoneal metastases).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Duarte. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.965Z"},{"nctId":"NCT06675955","title":"An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment","officialTitle":"An Open-label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-trial Access Program","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.\n\nFrom Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.","conditions":["Multiple Sclerosis"],"keywords":["Ocrelizumab"],"interventions":[{"type":"DRUG","name":"Ocrelizumab"}],"enrollment":500,"startDate":"2024-12-13","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \\[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally\n* The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study\n* Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential\n\nExclusion Criteria:\n\n* Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant\n* Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant\n* Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)\n* Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications\n* Concurrent participation in any therapeutic clinical trial (other than the parent study)\n* Immunocompromised state\n* Known active malignancy or are being actively monitored for recurrence of malignancy\n* Known presence of other neurological disorders","locations":[{"facility":"MHAT Avis Medica OOD Department of Neurology","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMHAT 'Dr. Georgi Stranski', EAD","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"MHATNP Sveti Naum EAD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Amiens Hopital Sud","city":"Amiens Cedex1","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHIC Cote Basque Bayonne","city":"Bayonne","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Besancon Hopital Jean Minjoz","city":"Besançon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Groupe Hospitalier Pellegrin","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Brest Hopital La Cavale Blanche","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital neurologique Pierre Wertheimer - CHU Lyon","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU De Caen","city":"Caen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Gabriel Montpied CHU de Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"CH St Vincent de Paul","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Roger Salengro Service de Neurologie","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Gui de Chauliac","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Nord Laennec","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Pasteur","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GroupeHospitalo-Universitaire Caremeau","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Intercommunal de Poissy","city":"Poissy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital de Hautepierre","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gesundheit Nord, Klinikum Bremen-Ost","city":"Bremen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz","city":"Westerstede","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Deutsche Klinik für Diagnostik","city":"Wiesbaden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital IV Alberto Sabogal Sologuren","city":"Bellavista","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nacional Guillermo Almenara Irigoyen","city":"La Victoria, Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nacional Dos de Mayo","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krasnoyarsk State Medical Academy","city":"Krasnoyarsk","state":"Krasnoyarsk Krai","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency","city":"Krasnoyarsk","state":"Krasnoyarsk Krai","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Center of Neurology of RAMS","city":"Moscow","state":"Moscow Oblast","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"City Clinical Hospital #24","city":"Moscow","state":"Moscow Oblast","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Federal center of brain research and neurotechnologies","city":"Moskva","state":"Moscow Oblast","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"SBIH City Clinical Hospital #31","city":"Saint Petersburg","state":"Sankt-Peterburg","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"LLC Osnova","city":"Saint Petersburg","state":"Sankt-Peterburg","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"N.P. Bechtereva Institute of the Human Brain","city":"Saint Petersburg","state":"Sankt-Peterburg","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"City Hospital #40 of Kurortniy Administrative District","city":"Saint Petersburg","state":"Sankt-Peterburg","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"SHI Sverdlovsk Regional Clinical Hospital #1","city":"Yekaterinburg","state":"Sverdlovsk Oblast","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vertebronevrologiya LLC","city":"Kazan'","state":"Tatarstan Republic","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ulyanovsk Regional Clinical Hospital","city":"Ulyanovsk","state":"Ulyanovsk Oblast","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center of Cardiology and Neurology","city":"Kirov","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regional clinical hospital named after prof. S.V. Ochapovsky","city":"Krasnodar","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FSBIH Siberian Regional Medical Centre of FMBA of Russia","city":"Novosibirsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perm SMA n.a. academ. E.A. Vagner","city":"Perm","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"5th Cherkasy City Center of Primary Health Care","city":"Cherkasy","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?","city":"Chernihiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bukovinsky SMU RMI Chernivtsi RCH","city":"Chernivtsi","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"SI USSRI of Medical and Social Problems of Disabilities of MOHU","city":"Dnipro","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regional Clinical Hospital","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU","city":"Kharkiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Dopomoga Plus","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center of Private Execution First Private Clinic","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Volyn Regional Clinical Hospital","city":"Lutsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lvivska oblasna tsentralna likarnia","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Clinical Research Center of Medical Center LLC Health Clinic","city":"Vinnytsi","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"LCC \"Medical center \"Unimed\"","city":"Zaporizhzhya","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council","city":"Zaporizhzhya","state":"","country":"Ukraine","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: MN45053 https://forpatients.roche.com/","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"}],"primaryOutcomes":["Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a)","Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["pleven-bulgaria","sofia-bulgaria","amiens-cedex1-france","bayonne-france","besan-on-france","bordeaux-france","brest-france","bron-france","caen-france","clermont-ferrand-france","lille-france","montpellier-france","nantes-france","nice-france","n-mes-france","poissy-france","strasbourg-france","bremen-germany","ulm-germany","westerstede-germany","wiesbaden-germany","bellavista-peru","la-victoria-lima-peru","lima-peru","krasnoyarsk-russia","moscow-russia","moskva-russia","saint-petersburg-russia","yekaterinburg-russia","kazan-russia","ulyanovsk-russia","kirov-russia","krasnodar-russia","novosibirsk-russia","perm-russia","cherkasy-ukraine","chernihiv-ukraine","chernivtsi-ukraine","dnipro-ukraine","ivano-frankivsk-ukraine","kharkiv-ukraine","kyiv-ukraine","lutsk-ukraine","lviv-ukraine","vinnytsi-ukraine","zaporizhzhya-ukraine"],"enrichment":{"headline":"Phase 3: testing Ocrelizumab for Multiple Sclerosis","inPlainEnglish":"The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab. From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.","whoItsFor":["Ages 18 Years to any","The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study","Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential"],"whoShouldSkip":["Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant","Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant","Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable)","Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications","Concurrent participation in any therapeutic clinical trial (other than the parent study)","Immunocompromised state","Known active malignancy or are being actively monitored for recurrence of malignancy"],"whatHappens":"If you join, the listed intervention(s) are Ocrelizumab. The registry lists allocation as na. The study will measure the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the whether it is safe and how hard side effects are to live with of ocrelizumab.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 500 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.989Z"},{"nctId":"NCT06676059","title":"SMART-r: Substance Monitoring and Active Relapse Tracking Repository","officialTitle":"SMART-r: Substance Monitoring and Active Relapse Tracking Repository","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute on Drug Abuse (NIDA)","sponsorClass":"NIH","summary":"Background:\n\nAbout 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program. For those who start treatment, about 70% return to substance use within weeks or months after starting treatment. To discover why patients drop out of treatment and return to substance use - and what can be done about it - researchers need to learn more about people who use drugs and alcohol.\n\nObjective:\n\nTo create a data repository by gathering survey and smartphone data from adults who use drugs and alcohol in order to conduct future research.\n\nEligibility:\n\nAdults who have used drugs or alcohol in the past and have a Android smartphone. The researchers will recruit targeted demographics at different times throughout the duration of the study period.\n\nDesign:\n\nData will be collected for up to 6 months. All research activities will be online.\n\nParticipants will download a smartphone app called TTRU-Curtis AWARE and keep it active on their phone. The app will run in the background and collect participant data, including: screen unlocks, duration of time the screen is on; apps used; words typed (except passwords); duration and time of phone calls; estimated location (exact location is not collected); and movement, such as how many steps are taken in a day. All personally identifying information is automatically removed before the data is stored (including phone numbers, names, or locations described in messages).\n\nEach day, participants will receive a text with a link to a survey. They will answer questions about their mood, behavior, and substance use from the day before. This survey should take less than 5 minutes to complete.\n\nEvery 30 days, participants will complete a longer survey. They will answer questions about their personal relationships, risky behaviors, mood, substance use, and feelings. They can skip any questions they do not feel comfortable answering. These surveys should take about 30 minutes to complete.\n\nParticipants may opt to allow researchers to access their social media posts.","conditions":["Alcoholism","Substance-Related Disorders"],"keywords":["Alcohol","Substance use","digital phenotyping"],"interventions":[],"enrollment":10000,"startDate":"2026-11-15","completionDate":"2044-12-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in the repository, an individual must meet all of the following criteria:\n\n* Must understand and be willing to complete an online informed consent process.\n* Be an adult aged 18 or older.\n* Self-report alcohol or other drug use within the past 30 days.\n* Have a smartphone as their primary mobile phone.\n\n  --For the AWARE app data monitoring procedure, there may be times during this study period where, due to technical or OS limitations, the app is only available to users of certain devices (e.g., Android, iOS). If there is such a limitation, this information will be evaluated during screening. For example, if the AWARE app is not available for iOS, then the screening form may exclude iPhone users for that time period where the limitation exists, if the only procedures offered are daily diary surveys and AWARE data monitoring.\n* Be willing to adhere to the procedures, such as downloading the AWARE app onto their smartphone and keeping it active throughout the data collection period, completing baseline questionnaires, daily diary EMAs, open-ended survey questions with the TTR Chatbot, uploading historical conversational AI data, and/or follow-up surveys.\n* Understand and write in English.\n\n  --This exclusion criterion is included because future research on the data collected will include linguistic analysis. all linguistic analyses, we remove rare words (e.g., words must be said by at least 95% of participants)95. Additionally, there are cultural differences across languages and, thus, interpreting language results across more than one language becomes difficult.96 As a result, we must keep analysis limited to a single language (English), since words in other languages will not meet that criteria.\n* Live in the United States.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this repository:\n\n1\\. Any impairment severe enough to preclude informed consent or valid self-report.","locations":[{"facility":"National Institute on Drug Abuse","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica E Hemmons","phone":"Not Listed","email":"jessie.hemmons@nih.gov"},{"name":"Brenda L Curtis, Ph.D.","phone":"(443) 740-2126","email":"brenda.curtis@nih.gov"}],"primaryOutcomes":["SMARTr data repository"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"SMART-r: Substance Monitoring and Active Relapse Tracking Repository","inPlainEnglish":"Background: About 1.5 million adults in the US enter alcohol or substance use treatment programs each year. Unfortunately, more than half of patients do not finish their program.","whoItsFor":["Ages 18 Years to 120 Years","In order to be eligible to participate in the repository, an individual must meet all of the following criteria:","Be an adult aged 18 or older","Self-report alcohol or other drug use within the past 30 days","Have a smartphone as their primary mobile phone","Understand and write in English","Live in the United States"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this repository:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 10,000 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.261Z"},{"nctId":"NCT06677060","title":"Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin","officialTitle":"A Phase III, Randomised, Placebo-controlled, Event-driven Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on the Risk of Incident Heart Failure and Cardiovascular Death","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.\n\nThe study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments. Participants will not be required to visit the site and no informed consent is required for the optional pre-screening period. The pre-screening assessments do not replace the full screening tests at Visit 1.\n\nUpon entering the screening period, all consented participants (after signature of screening ICF) will be screened during an up to 14-day screening period. Participants who meet all screening inclusion/exclusion criteria but are not treated with SGLT2i or are treated for less than 4 weeks will enter a run-in period with dapagliflozin 10 mg once daily for at least 4 weeks (and not more than 6 weeks) before randomisation.\n\nSite visits will take place at approximately 2-, 4-, 8-, 16-, and 34-weeks following randomisation. Thereafter visits will occur approximately every 4 months.\n\nThe study closure procedures will be initiated when the predetermined number of the first secondary endpoint events (ie, the composite of hospitalisation for HF or CV death) is predicted to have occurred i.e., the PACD.\n\nIn case of premature discontinuation of the blinded study intervention, participants will remain in the study. Unless a participant meets the dapagliflozin specific discontinuation criteria, they will continue to receive open label dapagliflozin 10 mg. It is important that the scheduled study visits and data collection continue according to the study protocol.","conditions":["Heart Failure"],"keywords":["Heart failure: Baxdrostat; Dapagliflozin; cardiovascular"],"interventions":[{"type":"DRUG","name":"Baxdrostat and dapagliflozin"},{"type":"OTHER","name":"Placebo and dapagliflozin"}],"enrollment":11300,"startDate":"2025-03-14","completionDate":"2029-12-17","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants of any sex and gender must be ≥ 40 years old at the time of signing the informed consent.\n* Diagnosed with T2DM and requiring treatment\n* Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)\n* History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit.\n* At least one additional risk factor for HF:\n\n  * Age ≥ 70 years\n  * UACR \\> 20 mg/g\n  * eGFR \\< 60 mL/min/1.73 m2\n  * History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)\n  * History of atrial fibrillation or atrial flutter\n  * NT-proBNP \\> 125 ng/L\n\nExclusion Criteria:\n\n* Previously confirmed diagnosis and treatment of heart failure\n* An eGFR \\< 30 mL/min/1.73 m2 at screening\n* Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening\n* Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol/mol) at screening\n* Serum sodium \\< 135 mmol/L at screening, determined as per central laboratory assessment\n* Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation\n* Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation\n* 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3: testing Baxdrostat and dapagliflozin for Heart Failure","inPlainEnglish":"Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF. The study will include an optional pre-screening period to facilitate sites' identification of potentially eligible participants to enter the full screening assessments.","whoItsFor":["Ages 40 Years to any","Diagnosed with T2DM and requiring treatment","Established CV disease (ischaemic heart disease, cerebrovascular disease, peripheral arterial disease)","History of HTN and an SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the Randomisation Visit","At least one additional risk factor for HF:","eGFR \\< 60 mL/min/1.73 m2","History of polyvascular disease (at least two of: ischaemic heart disease, cerebrovascular disease, and peripheral arterial disease)","History of atrial fibrillation or atrial flutter"],"whoShouldSkip":["Previously confirmed diagnosis and treatment of heart failure","An eGFR \\< 30 mL/min/1.73 m2 at screening","Known hyperkalaemia, defined as potassium ≥ 5.5 mmol/L within 3 months prior to screening","Type 1 diabetes mellitus or uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol/mol) at screening","Serum sodium \\< 135 mmol/L at screening, determined as per central laboratory assessment","Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, carotid angioplasty, or cardiac surgery, within 3 months prior to randomisation","Myocardial infarction within 3 months prior to randomisation, or within 1 month prior to randomisation when there is no further planned revascularisation"],"whatHappens":"If you join, the listed intervention(s) are Baxdrostat and dapagliflozin, or Placebo and dapagliflozin. The registry lists allocation as randomized. Participants include men and women ≥ 40 years of age with T2DM, established CV disease, a history of HTN with an SBP of at least 130 mmHg at screening, who meet the predefined serum potassium level, and with at least one additional risk factor for HF.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 11,300 people at 753 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.959Z"},{"nctId":"NCT06679062","title":"Suvorexant for Treatment of AUD and PTSD","officialTitle":"A Double-masked, Randomized, Phase II Study to Compare the Effectiveness of 20mg Oral Suvorexant (SUV) Versus Placebo (1:1) in Participants With Co-occurring Alcohol Use Disorder (AUD) and Posttraumatic Stress Disorder (PTSD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Pharmacotherapies for Alcohol and Substance Use Disorders Alliance","sponsorClass":"OTHER","summary":"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day placebo run-in period, followed by a random assignment to receive placebo or suvorexant for an additonal 14 days. Post-randomization, participants will attempt to stop drinking for two weeks and will complete daily virtual diaries and study outcome assessments via in-person clinic visits on days 7 and 14.","conditions":["Alcohol Use Disorder (AUD)","Post Traumatic Stress Disorder (PTSD)","Insomnia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Suvorexant"},{"type":"OTHER","name":"Placebo"}],"enrollment":76,"startDate":"2025-07-16","completionDate":"2027-03","sex":"ALL","minAge":"21 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 21 and 65.\n* Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI.\n* Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \\> 30.\n* Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment.\n* Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day.\n* Agree to abstain from all other sleep medications (starting at Day -7).\n* Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s/he will lose his/her housing in the next month.\n\nExclusion Criteria:\n\n* A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\< moderate level on DSM 5).\n* A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder.\n* Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6).\n* Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar).\n* Currently pregnant, nursing, or no reliable method of birth control (females only).\n* Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders).\n* Use of suvorexant (within 30 days of Day -7).\n* Currently on prescription medication that contraindicates use of suvorexant (including moderate or strong Cytochrome P450 3A modulators (CYP3A inhibitors and inducers))\n* Hepatic insufficiency (AST/ALT \\> 5x upper limit of normal (ULN)).\n* Suicidal Ideation determined by greater than moderate Columbia Suicide Severity Rating Scale.\n* Inability to provide evidence of 48-hour alcohol abstinence (self-report, BrAC, EtG) at Day 0 AND failure after second attempt at 48-hour abstinence.","locations":[{"facility":"University of California - Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center - Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Scott Lane, PhD","phone":"713-486-2535","email":"scott.d.lane@uth.tmc.edu"},{"name":"Lara Ray, PhD","phone":"","email":"lararay@psych.ucla.edu"}],"primaryOutcomes":["Change in Insomnia Severity Index (ISI) score from baseline to Day 14."],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["los-angeles-california","houston-texas"],"enrichment":{"headline":"Phase 2: testing Suvorexant for Alcohol Use Disorder (AUD)","inPlainEnglish":"This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD). All participants will have a 7-day dummy treatment (placebo) run-in period, followed by a random assignment to receive dummy treatment (placebo) or suvorexant for an additonal 14 days.","whoItsFor":["Ages 21 Years to 65 Years","Age between 21 and 65","Meet current (i.e., past 12-month at Day -7/-6) DSM-5 diagnostic criteria for moderate or severe AUD as determined by the MINI","Currently experiencing PTSD symptoms at screening (Day -7/-6) as indicated by PCL-5 cut-score \\> 30","Intrinsic motivation to reduce or quit drinking (defined as self-reported intention at screening to reduce or quit drinking within the next 6 months) and to receive PTSD treatment","Must have an ISI score equal to or \\> 7 (subthreshold insomnia). ISI score below 7 at screening will not be included or proceed beyond the screening day","Agree to abstain from all other sleep medications (starting at Day -7)","Have a place to live in the 2 weeks prior to randomization (Day 0) and not be at risk that s/he will lose his/her housing in the next month"],"whoShouldSkip":["A current (past 12-month at Day -7/-6) DSM-5 diagnosis via the MINI of substance use disorder for any substances other than alcohol, nicotine, or marijuana (\\< moderate level on DSM 5)","A lifetime DSM-5 diagnosis via the MINI of schizophrenia, bipolar disorder, or psychotic disorder","Positive urine test for any recreational drugs other than marijuana at screening (Day -7/-6)","Current clinically significant alcohol withdrawal (i.e., score ≥ 10 on the CIWA-Ar)","Currently pregnant, nursing, or no reliable method of birth control (females only)","Any clinically significant medical condition that would preclude safe participation in the study (e.g. narcolepsy, seizure disorder, or other clinically significant cardiovascular, hematologic, hepatic, renal, neurological, or endocrine disorders)","Use of suvorexant (within 30 days of Day -7)"],"whatHappens":"If you join, the listed intervention(s) are Suvorexant, or Placebo. The registry lists allocation as randomized. This study is to determine if suvorexant (SUV) will reduce insomnia in 76 men and women veteran and non-veterans between the ages 21-65 with posttraumatic stress disorder (PTSD) symptoms and alcohol use disorder (AUD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 76 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.419Z"},{"nctId":"NCT06680596","title":"Detecting Tumor DNA in the Blood of HR+/HER2-low Metastatic Breast Cancer Patients to Find Candidates for T-DXd Therapy","officialTitle":"A ctDNA Screening Program in Patients With HR+, HER2 Low Metastatic Breast Cancer for Detection of High-risk Relapse Patients on Any CDK4/6 Inhibitor Followed by a Single Arm Phase II Trial of Trastuzumab-deruxtecan in Patients With Persistent ctDNA After 1 Month of Treatment With Endocrine Therapy Combined With CDK4/6 Inhibitor","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"UNICANCER","sponsorClass":"OTHER","summary":"After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the efficacy of trastuzumab deruxtecan in terms of progression-free survival (PFS).","conditions":["Breast Cancer Metastatic","Breast Cancer Stage IV"],"keywords":["HR+","HER2 low","HER2 ultralow","molecular screening","ctDNA","T-DXd","Antibody-drug conjugate","trastuzumab deruxtecan","Breast cancer metastatic"],"interventions":[{"type":"DRUG","name":"trastuzumab derxutecan"}],"enrollment":80,"startDate":"2025-07-30","completionDate":"2028-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"SCREENING PHASE\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInclusion criteria\n\n1. Patient must have signed the written informed consent for screening phase prior to any trial specific procedures.\n\n   Note: When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Patient is ≥18 years of age.\n3. Documented breast cancer that:\n\n   * Is metastatic and eligible to biopsy for subsequent histological or cytological confirmation,\n   * Is HER2 low (HER2 1+, or 2+ and in situ hybridization (ISH) negative) or HER2 ultra low (IHC 0 with incomplete and faint membrane staining in \\>0 and ≤10% of tumor cells) on the most recent tumor material available, as defined by the local pathologist under ASCO/CAP guidelines,\n   * Is HR-positive (positive for estrogen receptor or progesterone receptor ≥10% of tumor cell nuclei are immunoreactive) in the metastatic setting.\n4. Patient has either:\n\n   * a metastatic relapse during or within 1 year after termination of the adjuvant endocrine therapy (AI resistant), or\n   * a metastatic relapse more than one year of completing adjuvant AI or a de-novo metastatic breast cancer (AI sensitive/naive).\n5. For AI resistant population: patient has previously gone through the ctDNA screening part of the SAFIR 03 - SCREENING/ARRIBA study and fulfilled all the inclusion criteria and none of the exclusion criteria.\n6. Patient did not receive any therapy in the metastatic setting.\n7. Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) in combination with either AI or fulvestrant, according to its marketing authorisation.\n8. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.\n9. Patient has an adequate bone marrow and organ function.\n10. Patient has a measurable or an evaluable disease according to Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1).\n11. Availability of an archived metastatic tumor sample (FFPE) for exploratory research. Bone metastasis are accepted if tissue is representative of tumor tissue (at least 10% tumor cellularity).\n12. Patient must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n13. Registration in a National Health Care System (or equivalent).\n\nExclusion criteria:\n\n1. Patient is eligible to chemotherapy because of visceral crisis.\n2. Patient has a breast cancer amenable for resection or radiation therapy with curative intent.\n3. Prior exposure to antibody-drug conjugate or CDK4/6 inhibitors (in metastatic setting). CDK4/6 inhibitors given in adjuvant setting must be stopped for at least 12 months prior screening\n4. Patient who has initiated the CDK4/6 inhibitor treatment.\n5. Patient is unable to swallow tablets.\n6. Patient has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis requiring steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at baseline\n7. Patient has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n8. Patient has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n9. Person deprived of their liberty or under protective custody or guardianship.\n10. Social, familial, or geographic factors that would interfere with study participation or follow-up.\n\nTREATMENT PHASE\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nInclusion criteria\n\n1. Patient must have signed the written informed consent for the treatment phase prior to any trial specific procedures.\n\n   Note: When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent.\n2. Patient must have discontinued CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) at least 7 days before enrolment, but no longer than 14 days\n3. Patients must present a no drop of ctDNA determined by a ctDNA assay after 4 weeks of standard of care treatment with a CDK4/6 inhibitor\n4. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.\n5. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to enrolment.\n6. Participant has adequate bone marrow and organ function within 14 days before enrolment, defined as the following laboratory values:\n\n   * Absolute neutrophil count (ANC) ≥1500/mm³,\n   * platelet count ≥100,000/mm³,\n   * haemoglobin ≥9.0 g/dl,\n   * Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥30 mL/min,\n   * Serum albumin ≥2.5 g/dL,\n   * Total bilirubin ≤1.5 × ULN (\\<3 ULN if Gilbert's disease),\n   * In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. If the participant has liver metastases, ALT and AST \\< 5 × ULN, he/she will be eligible for the study,\n   * Adequate blood clotting function: defined as an international normalized ratio/prothrombin time ≤1.5 × ULN and either partial thromboplastin time or activated partial thromboplastin time within normal limits.\n\n   Note: Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 14 days prior to the day on which bone marrow function is assessed, or at any time after this day and prior to cycle 1 day 1.\n7. Women of childbearing potential must have a negative serum pregnancy test (with a sensitivity of at least 25 mIU/mL) result within 3 days of enrolment.\n8. Men or women of childbearing potential must agree to the use of effective contraceptive for the study duration and for at least 7 months after the last dose of study treatment for women, and at least 4 months for men.\n9. Patient must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion criteria:\n\n1. AI resistant patients who are eligible to SAFIR 03 - ARRIBA trial (i.e. PIK3CA mutated patients), until SAFIR 03 - ARRIBA study closure or study steering committee's decision.\n2. Patient has received more than 2 cycles of the ongoing CDK4/6 inhibitor treatment combined with either AI or fulvestrant.\n3. Patient has interrupted the ongoing CDK4/6 inhibitor treatment for more than 14 days.\n4. Patient has evidence of clinical or radiological disease progression.\n5. Patient has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.\n\n   Note: Patients may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to enrolment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: Chemotherapy-induced neuropathy and fatigue.\n6. Patient has malignancies within 3 years, other than that under study, with the exception of: adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.\n7. Patient is at high medical risk because of severe or uncontrolled systemic disease, such as uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, chronic pancreatitis, chronic active infection with hepatitis B virus, hepatitis C virus, or HIV, active untreated or uncontrolled fungal, bacterial or viral infections, active primary immunodeficiency etc.\n8. Uncontrolled or significant cardiovascular disease, including any of the following:\n\n   * History of myocardial infarction within 6 months before enrolment,\n   * History of symptomatic congestive heart failure (New York Heart Association Class II to IV),\n   * Patient with a corrected QT interval (QTc) prolongation to \\>470 ms (females) or \\>450 ms (males) based on average of the screening triplicate12-lead ECG,\n   * Patients with known troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrolment to rule out myocardial infarction.\n9. Clinically severe pulmonary compromise resulting from current pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrolment, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjögren's, sarcoidosis, etc.), or prior pneumonectomy.\n10. Patient has spinal cord compression or clinically active central nervous system metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n11. Major surgery within 4 weeks before study enrolment.\n12. Patient who has received radiotherapy ≤4 weeks or limited field radiation for palliation ≤2 weeks prior to enrolment, or who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥25% of the bone marrow was irradiated\n13. Patient using drugs that could have pharmacokinetics interaction with investigational drugs. Concomitant use of strong CYP3A4 inhibitors or OATP 1B inhibitors should be avoided. If concomitant use of strong CYP3A4 or OATP 1B inhibitors is unavoidable, consider delaying T-DXd treatment until the inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible. If a strong CYP3A4 inhibitor or an OATP 1B inhibitor is co-administered and T-DXd treatment cannot be delayed, patients should be closely monitored for adverse reactions.\n14. Patient receiving drug that may cause QTc prolongations or cardiac arrhythmia. Pimozide (Orap®) and cisapride (Prepulsid®) are strictly contraindicated: they are associated with a major risk of ventricular rhythm disorder.\n15. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of T-DXd.\n16. Participation in a therapeutic clinical study within 4 weeks before enrolment.\n17. Patient is currently pregnant, breastfeeding, or planning to become pregnant\n18. Patient has substance abuse history or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the patient's participation in the clinical study or evaluation of the clinical study results.\n19. Person deprived of their liberty or under protective custody or guardianship.\n20. Social, familial, or geographic factors that would interfere with study participation or follow-up.","locations":[{"facility":"Chu Amiens Picardie","city":"Amiens","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique de L'Europe Amiens - Cthe","city":"Amiens","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier D'Auxerre","city":"Auxerre","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sainte Catherine Institut Du Cancer Avignon Provence","city":"Avignon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de la Côte Basque","city":"Bayonne","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Beauvais","city":"Beauvais","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancerologie Des Hauts de France - Centre Pierre Curie","city":"Beuvry","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Simone Veil de Blois","city":"Blois","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Boulogne-Sur-Mer","city":"Boulogne-sur-Mer","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu de Brest - Hôpital Cavale Blanche","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Pasteur Lanroze - Cfro - Groupe Vivalto Sante","city":"Brest","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier William Morey","city":"Chalon-sur-Saône","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Cholet","city":"Cholet","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pôle Santé République (Elsan)","city":"Clermont-Ferrand","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Jean Perrin","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Alpes Léman","city":"Contamine-sur-Arve","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique de Flandre","city":"Coudekerque-Branche","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chi Fréjus-Saint-Raphaël","city":"Fréjus","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chd Vendée","city":"La Roche-sur-Yon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Léon Bérard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Prive Jean Mermoz","city":"Lyon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique de La Sauvegarde","city":"Lyon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli Calmettes","city":"Marseille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Icm Val D'Aurelle","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medipôle de Nancy - Cog-Ilc (Polyclinique de Gentilly)","city":"Nancy","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Médico-Chirurgical (Cmc) Ambroise Paré-Hartmann","city":"Neuilly-sur-Seine","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Antoine Lacassagne","city":"Nice","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nimes","city":"Nîmes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Saint-Louis","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Groupe Hospitalier Diaconesses Croix Saint-Simon","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Pau","city":"Pau","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Privé Des Côtes D'Armor (Hpca) - Cario","city":"Plérin","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Godinot","city":"Reims","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugene Marquis","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chp Saint-Grégoire - Groupe Vivalto Sante","city":"Saint-Grégoire","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique Sainte-Anne - Gh Saint-Vincent","city":"Strasbourg","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux Du Léman","city":"Thonon-les-Bains","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancerologie de Lorraine","city":"Vandœuvre-lès-Nancy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"François LEGRAND","phone":"01 73 79 73 02","email":"safir03libherty@unicancer.fr"},{"name":"Marta JIMENEZ","phone":"","email":"m-jimenez@unicancer.fr"}],"primaryOutcomes":["Progression Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["amiens-france","auxerre-france","avignon-france","bayonne-france","beauvais-france","beuvry-france","blois-france","boulogne-sur-mer-france","brest-france","chalon-sur-sa-ne-france","cholet-france","clermont-ferrand-france","contamine-sur-arve-france","coudekerque-branche-france","fr-jus-france","la-roche-sur-yon-france","lyon-france","marseille-france","montpellier-france","nancy-france","neuilly-sur-seine-france","nice-france","n-mes-france","paris-france","pau-france","pl-rin-france","reims-france","rennes-france","saint-gr-goire-france","strasbourg-france","thonon-les-bains-france","vand-uvre-l-s-nancy-france","villejuif-france"],"enrichment":{"headline":"Phase 2: testing trastuzumab derxutecan for Breast Cancer Metastatic","inPlainEnglish":"After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the how well it works of trastuzumab deruxtecan in terms of progression-free survival (PFS).","whoItsFor":["Ages 18 Years to any","SCREENING PHASE\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_","Patient is ≥18 years of age","Documented breast cancer that:","Is metastatic and eligible to biopsy for subsequent histological or cytological confirmation,","Is HER2 low (HER2 1+, or 2+ and in situ hybridization (ISH) negative) or HER2 ultra low (IHC 0 with incomplete and faint membrane staining in \\>0 and ≤10% of tumor cells) on the most recent tumor material available, as defined by the local pathologist under ASCO/CAP guidelines,","Is HR-positive (positive for estrogen receptor or progesterone receptor ≥10% of tumor cell nuclei are immunoreactive) in the metastatic setting","Patient has either:"],"whoShouldSkip":["Patient did not receive any therapy in the metastatic setting","Patient is eligible for a first-line treatment with a marketed CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) in combination with either AI or fulvestrant, according to its marketing authorisation","Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1","Patient has an adequate bone marrow and organ function","Patient has a measurable or an evaluable disease according to Response Evaluation Criteria In Solid Tumours version 1.1 (RECIST v1.1)","Availability of an archived metastatic tumor sample (FFPE) for exploratory research. Bone metastasis are accepted if tissue is representative of tumor tissue (at least 10% tumor cellularity)","Patient must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures"],"whatHappens":"If you join, the listed intervention(s) are trastuzumab derxutecan. The registry lists allocation as na. After an initial screening phase to identify patients with persistent blood circulating DNA tumors, patients will be enrolled in the treatment phase that was designed as an open-label, multicentre, phase II study, to test the how well it works of trastuzumab deruxtecan in terms of progression-free survival (PFS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at 39 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.343Z"},{"nctId":"NCT06681818","title":"Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy","officialTitle":"Postoperative Heme Oxygenase Induction and Carbon Monoxide Production as a Novel Method to Assess Hepatic Regeneration and Predict Hepatic Related Morbidity After Partial Hepatectomy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Englewood Hospital and Medical Center","sponsorClass":"OTHER","summary":"the investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings to the rate of liver regeneration and liver function.","conditions":["Liver Cancer Adult","Liver Regeneration"],"keywords":["hepatectomy","ablation"],"interventions":[{"type":"OTHER","name":"carbon monoxide measurement via smokerlyzer"}],"enrollment":125,"startDate":"2024-11-21","completionDate":"2039-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient plans to have an ablation or partial liver resection for primary liver pathology or metastatic disease\n* Patient is able to comprehend and willing to sign the written consent form\n\nExclusion Criteria:\n\n* Patients \\< 18 years\n* Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test","locations":[{"facility":"Englewood Hospital","city":"Englewood","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jamie Ketas","phone":"2018943418","email":"jamie.ketas@ehmchealth.org"},{"name":"Raquel Molina","phone":"","email":"raquel.molina@ehmchealth.org"}],"primaryOutcomes":["correlation of carbon monoxide levels in exhaled breath with quantity and quality of liver regeneration"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["englewood-new-jersey"],"enrichment":{"headline":"Not a traditional drug phase: carbon monoxide measurement via smokerlyzer for Liver Cancer Adult","inPlainEnglish":"The investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings to the rate of liver regeneration and liver function.","whoItsFor":["Ages 18 Years to any","Patient plans to have an ablation or partial liver resection for primary liver pathology or metastatic disease","Patient is able to comprehend and willing to sign the written consent form"],"whoShouldSkip":["Patients \\< 18 years","Patients identified as members of a vulnerable population, except women of child bearing potential with negative pregnancy test"],"whatHappens":"If you join, the listed intervention(s) are carbon monoxide measurement via smokerlyzer. The registry lists allocation as na. The investigators will pursue two specific aims: (1) to monitor the extent of heme oxygenase induction (by measuring endogenous CO production) in relationship to the extent of hepatic resection or ablation(2) to assess the production of CO in patients following liver resection or ablation and correlate these findings to the rate of liver regeneration and liver function.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 125 people at Englewood. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.630Z"},{"nctId":"NCT06686394","title":"Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009)","officialTitle":"HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body). The goals of this study are to learn:\n\n* About the safety and how well people tolerate of patritumab deruxtecan\n* How many people have the cancer respond (get smaller or go away) to treatment","conditions":["Breast Neoplasms","Breast Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Patritumab deruxtecan"},{"type":"BIOLOGICAL","name":"Trastuzumab"},{"type":"BIOLOGICAL","name":"Trastuzumab Biosimilar"},{"type":"BIOLOGICAL","name":"Pertuzumab"},{"type":"BIOLOGICAL","name":"Tucatinib"}],"enrollment":181,"startDate":"2025-02-26","completionDate":"2032-08-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention\n\nPart 1 Arm 1:\n\n* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment\n\nPart 1 Arm 2:\n\n-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n\nPart 1 Arm 3:\n\n-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.\n\nPart 2 : Has not received prior systemic therapy (including T-DXd) for recurrent locally advanced or metastatic breast cancer (mBC).\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Uncontrolled or significant cardiovascular disease\n* Has any history of (noninfectious) interstitial lung disease (ILD)/ pneumonitis irrespective of steroid use or has current ILD or suspected ILD\n* Has clinically severe respiratory compromise\n* Has any history of or evidence of any current leptomeningeal disease\n* Has clinically significant corneal disease\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection\n* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Part 1: Evidence of spinal cord compression or brain metastases\n* Part 2: Evidence of spinal cord compression or brain/CNS metastases.\n* Has an active infection requiring systemic therapy\n* Concurrent active HBV and HCV infection\n* Has had major surgical procedure (excluding placement of vascular access) less than 28 days\n\nPart1: Arm 3 ONLY\n\n\\- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting","locations":[{"facility":"University of Colorado Anschutz Medical Campus ( Site 0057)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute ( Site 0050)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey ( Site 0052)","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute ( Site 0051)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kingston General Hospital ( Site 0061)","city":"Kingston","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0001)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 0004)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital ( Site 0003)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0011)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 0012)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0010)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya City University Hospital ( Site 0020)","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 0030)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 0031)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospital ( Site 0041)","city":"London","state":"Camden","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Beatson West of Scotland Cancer Centre ( Site 0043)","city":"Glasgow","state":"Glasgow City","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew s Hospital ( Site 0040)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part 1: Number of Participants Experiencing Dose-Limiting Toxicity (DLT)","Part 1: Number of Participants with One or More Adverse Events (AEs)","Part 1: Number of Participants who Discontinue Study Intervention Due to an AE","Part 2: Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["aurora-colorado","boston-massachusetts","new-brunswick-new-jersey","greenville-south-carolina","fairfax-virginia","kingston-canada","toronto-canada","montreal-canada","haifa-israel","petah-tikva-israel","ramat-gan-israel","nagoya-japan","seoul-south-korea","london-united-kingdom","glasgow-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Patritumab deruxtecan for Breast Neoplasms","inPlainEnglish":"Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers. The breast cancers being studied are HER2 positive unresectable locally advanced or metastatic (the cancer has spread to other parts of the body).","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer","Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation","Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable","Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention","Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Patritumab deruxtecan, Trastuzumab, or Trastuzumab Biosimilar. The registry lists allocation as randomized. Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain breast cancers.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 181 people at 18 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.352Z"},{"nctId":"NCT06691698","title":"Evaluation of CO-OP for Adolescents With Mild Intellectual Disability","officialTitle":"Evaluation of The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for Adolescents With Mild Intellectual Disability","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Örebro University, Sweden","sponsorClass":"OTHER","summary":"Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age. One difficulty is to create strategies for and solve problems related to everyday occupations. Treatment options with good evidence to enhance occupational performance for persons with ID are limited. The Cognitive Orientation to Daily Occupational Performance (CO-OP) is an approach with good evidence within other diagnostic groups, i.e. adolescents with cerebral palsy. CO-OP has a unique person-centered approach where the person chooses his/her own goals and creates his/her own strategies to reach them. Initial research shows potential for CO-OP with adolescents with ID, although due to scientific flaws there is still a lack of evidence regarding feasibility and effectiveness for adolescents with ID. Based on the results with other diagnostic groups and clinical knowledge and experience, CO-OP can be assumed to be feasible and effective for adolescents with ID and to have a long term effect transferred to everyday life in a way other treatment options do not.\n\nThe aim of the project is to describe and evaluate CO-OP for adolescents with mild ID. Participants will be adolescents aged 13-17 and their parents. The project is designed as a feasibility study with two qualitative, one quantitative and one mixed method data collection. The quantitative data will be ordinal and nominal data from observational and self-assessment assessments. The mixed methods include comparison between filmed sessions and the CO-OP manual, use of field notes to analyse fidelity and needs for adaptations, and comparison between the CO-OP manual and policy documents. The qualitative outcome will be experiences by the adolescents and perceptions of CO-OP by parents.","conditions":["Intellectual Disability, Mild"],"keywords":["adolescents","executive function","metacognition","mild intellectual disability","occupational therapy","occupational performance","person-centered intervention","self-efficacy"],"interventions":[{"type":"OTHER","name":"The Cognitive Orientation to Daily Occupational Performance Approach"}],"enrollment":60,"startDate":"2025-01-16","completionDate":"2027-12","sex":"ALL","minAge":"13 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Study I-II\n\nInclusion criteria\n\n* 13-17 years\n* Diagnosed mild intellectual disability\n* Motivation to reach self-selected goals\n* Ability to identify those goals\n* Possibility to meet once a week for ten weeks\n* Access to a parent or significant other for support during intervention\n\nExclusion criteria:\n\n* Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)\n* Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder\n* Progressive diagnoses\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs).\n\nStudy III\n\nInclusion criteria:\n\n* 13-17 years\n* Diagnosed mild intellectual disability\n* Completed CO-OP intervention or at lest half way trough the intervention\n* Opportunity to meet physically for an interview with in a month post and 6 months post intervention.\n* CO-OP intervention done with high fidelity to CO-OP format with a CO-OP therapist that has written field notes, preferrably recruited from study I-II.\n\nExclusion criteria:\n\n* Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)\n* Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder\n* Progressive diagnoses\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs).\n\nStudy IV\n\nInclusion criteria:\n\n* Parents with legal guardianship that lives full- or part time with an adolescent reaching the inclusion criteria for study I who has completed CO-OP within or out of the project\n* Opportunity to meet physically for an interview with in a month post and 6 months post the adolescent's completed, or at least half way through, CO-OP intervention.\n\nExclusion criteria:\n\n* Need for language interpreting\n* Need for alternative and augmentative communication (i.e. pictures or signs)\n* Irregular and brief living with the adolescent comparable to less than half-time and therefore does not observe the adolescent's occupational performance enough to answer the interview questions.","locations":[{"facility":"Region Skåne","city":"Kristianstad","state":"Skåne County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Region Värmland","city":"Karlstad","state":"Värmland County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Region Örebro County","city":"Örebro","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elin Widmark, MSc","phone":"+46108319064","email":"elin.widmark@oru.se"},{"name":"Marie Holmefur, PhD","phone":"+4619303612","email":"marie.holmefur@oru.se"}],"primaryOutcomes":["Change in Canadian Occupational Performance Measure - performance","Change in Canadian Occupational Performance Measure - satisfaction","Change in Performance Quality Rating Scale - occupational performance quality"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["kristianstad-sweden","karlstad-sweden","rebro-sweden"],"enrichment":{"headline":"Not a traditional drug phase: The Cognitive Orientation to Daily Occupational Performance Approach for Intellectual Disability, Mild","inPlainEnglish":"Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age. One difficulty is to create strategies for and solve problems related to everyday occupations.","whoItsFor":["Ages 13 Years to 17 Years","Diagnosed mild intellectual disability","Motivation to reach self-selected goals","Ability to identify those goals","Possibility to meet once a week for ten weeks","Access to a parent or significant other for support during intervention"],"whoShouldSkip":["Movement related diagnosis (i.e. cerebral palsy or neuro muscular diseases)","Diagnosed attention deficit hyperactivity disorder/attention deficit disorder (ADHD/ADD) or autism spectrum disorder","Progressive diagnoses","Need for language interpreting","Need for alternative and augmentative communication (i.e. pictures or signs)","who can join:","Diagnosed mild intellectual disability"],"whatHappens":"If you join, the listed intervention(s) are The Cognitive Orientation to Daily Occupational Performance Approach. The registry lists allocation as na. Intellectual disability (ID) affects a person throughout life and includes difficulties to manage what is expected in everyday life based on age.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.149Z"},{"nctId":"NCT06692192","title":"The RECAP2 Study: Midazolam and Psilocybin","officialTitle":"Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.\n\nResearchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.\n\nParticipants will:\n\n* Receive one of four possible combinations of medications\n* Undergo an MRI\n* Complete questionnaires\n* Undergo transcranial magnetic stimulation (TMS) and EEG\n* Volunteer for an open-label follow-up phase of study","conditions":["Psilocybin"],"keywords":["sub-optimal wellbeing"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Midazolam"},{"type":"DRUG","name":"Saline"}],"enrollment":60,"startDate":"2025-08-07","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 65 years at screening, of any identified gender and racial/ethnic group\n* Physically healthy; does not meet criteria for an exclusionary medical condition\n* English-speaking (able to provide consent and complete questionnaires)\n* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder\n* Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)\n\nExclusion Criteria:\n\n* Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation\n* Exclusionary medical conditions\n* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)\n* Clinically significant electrocardiogram (ECG)\n* Use of psychotropic or CNS-altering medications within 3 months of screening\n* Hypertension or tachycardia\n\nParticipants invited to participate in the 28-day open label follow-up phase will:\n\n1. Fully complete all activities associated with the randomized phase, including the virtual Day 84 assessment, before being approached about participation in the open label phase.\n2. Participants who meet stopping criteria during the randomized phase are not eligible to enroll in the open label phase.\n3. Participants who withdraw from the randomized phase are not eligible to enroll in the open label phase.\n4. Enrollment into the open label phase must occur in the following sequence:\n\n   1. participants who have fully completed the randomized phase are screened for eligibility;\n   2. eligible participants meet with the study team and provide informed consent for the open label phase;\n   3. baseline eligibility is reassessed to confirm that participation in the open label phase remains appropriate and safe.\n\nThe Principal Investigator may decline or defer open-label enrollment when unresolved concerns make participation unsafe or scientifically inappropriate.","locations":[{"facility":"UW School of Medicine and Public Health","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"RECAP Study Contact","phone":"608-263-4852","email":"recap2@psychiatry.wisc.edu"}],"primaryOutcomes":["Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)","Change in Brief Experiential Avoidance Questionnaire (BEAQ)","Change in Probabilistic Reversal Learning (PRL)","Change in transcranial magnetic stimulation evoked potential (TEP) amplitude"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["madison-wisconsin"],"enrichment":{"headline":"Phase 1: testing Psilocybin for Psilocybin","inPlainEnglish":"The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing. Researchers will compare different doses of psilocybin combined with midazolam or dummy treatment (placebo) to see what dose induces increased wellbeing.","whoItsFor":["Ages 18 Years to 65 Years","Age 18 to 65 years at screening, of any identified gender and racial/ethnic group","Physically healthy; does not meet criteria for an exclusionary medical condition","Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder","Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)"],"whoShouldSkip":["Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation","Exclusionary medical conditions","Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)","Clinically significant electrocardiogram (ECG)","Use of psychotropic or CNS-altering medications within 3 months of screening","Hypertension or tachycardia","Participants invited to participate in the 28-day open label follow-up phase will:"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, Psilocybin, or Midazolam. The registry lists allocation as randomized. The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at Madison. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.092Z"},{"nctId":"NCT06695845","title":"A Phase 2 Study of Zanidatamab in Patients With HER2-expressing Tumors","officialTitle":"A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Jazz Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.","conditions":["Breast Cancer","Gastric Cancer","Esophageal Cancer","Gastroesophageal Cancer","Colorectal Cancer","Endometrial Cancer","Non-small Cell Lung Cancer","Ovarian Cancer","Urothelial Carcinoma","Salivary Gland Cancer","Pancreatic Cancer","HER-2 Protein Overexpression"],"keywords":["JZP598","ZW25","HER2 IHC 3+ Overexpression Solid Tumors"],"interventions":[{"type":"DRUG","name":"Zanidatamab"}],"enrollment":200,"startDate":"2025-01-14","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Is at least 18 years of age inclusive at the time of signing the informed consent\n2. Participants with locally advanced, unresectable, or metastatic solid tumors (except Biliary Tract Cancer (BTC), defined as gallbladder cancer or cholangiocarcinoma) who have progressed following at least 1 prior systemic treatment for metastatic or advanced disease and have no available treatment options that have confirmed benefit. Prior treatment with HER2-targeted therapy is not permitted (Cohort 1 only). For participants with breast cancer (Cohort 2) or GEA (Cohort 3), prior HER2-targeted therapy is permitted and prior therapy with trastuzumab deruxtecan (T-DXd) is required.\n3. HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory.\n4. All participants must have adequate tumor sample for submission to allow central HER2 testing.\n5. Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)\n6. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Has a life expectancy of at least 3 months, in the opinion of the investigator.\n8. Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:\n\n   1. Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS.\n   2. Participants with treated CNS metastases that are no longer symptomatic may be included in the study if they recovered to \\< Grade 1 (CTCAE Version 5.0 or higher) or baseline from the acute toxic effect associated with the treatment \\> 7 days prior to Cycle 1 Day 1.\n   3. Prior stereotactic radiosurgery or stereotactic radiotherapy should be completed at least 7 days (≥ 7 days) before the first dose of study intervention.\n9. Adequate organ functions.\n10. Females of childbearing potential must have a negative pregnancy test result.\n11. Females of childbearing potential and males with a partner of childbearing potential must be willing to use 2 methods of birth control.\n\nExclusion Criteria:\n\n1. Has known or suspected leptomeningeal disease and/or untreated brain metastasis.\n2. Has uncontrolled or significant cardiovascular disease\n3. Has ongoing toxicity related to prior cancer therapy\n4. Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals.\n5. Has known Human Immunodeficiency Virus (HIV) infection.\n6. Has active hepatitis B or C infection.\n7. Has an active SARS-CoV-2 infection.\n8. Has a history of life-threatening hypersensitivity to monoclonal antibody (mAbs) or to recombinant proteins or excipients in the drug formulation of zanidatamab.\n9. Has any serious underlying medical or psychiatric condition that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site.\n10. Has any issue or condition that, in the opinion of the investigator, would contraindicate the participant's participation in the study or confound the results of the study.\n11. Prior treatment with HER2-targeted therapy (Cohort 1 only).\n12. Has a history of trauma or major surgery\n13. Was treated with systemic antineoplastic therapy, including hormonal therapies for breast cancer, or any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.\n14. Received zanidatamab at any time prior to the current study.\n15. Colorectal Cancer (CRC) participants with known KRAS/NRAS and BRAF mutations.\n16. Non-Small Cell Lung Cancer (NSCLC) participants with known ALK, EGFR mutations and ROS1 fusion.\n17. Female participants who are breastfeeding or pregnant, and female and male participants planning a pregnancy.\n18. Prior or concurrent invasive malignancy other than the disease under study, whose natural history or treatment has, in the opinion of the investigator or medical monitor, the potential to interfere with the safety or efficacy assessment of the investigational regimen.","locations":[{"facility":"Arizona Oncology Associates, PC - NAHOA","city":"Prescott","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Center","city":"Littleton","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - South","city":"Fort Myers","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - Lake Nona","city":"Orlando","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - North","city":"St. Petersburg","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - East","city":"West Palm Beach","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Affiliated Oncologists","city":"Chicago Ridge","state":"Illinois","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Kansas Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Northwell Health Cancer Institute","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Cancer Specialists","city":"Horsham","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Tennessee Cancer Specialists","city":"Knoxville","state":"Tennessee","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - West Texas","city":"Amarillo","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Texas Oncology - DFW","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Blue Ridge Cancer Care","city":"Roanoke","state":"Virginia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"JSC Vian- Krystyna Kiel Oncology Center","city":"Kutaisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"LTD Todua Clinic","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Research Centre","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"LTD Caucasus Medical Centre","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Suwon","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea St Vincent's Hospital","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chonnam National University Hwasun Hospital","city":"Hwasun-Eup","state":"Hwasun-Gun","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Gangnam-gu","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Guro-gu","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Jongno-gu","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seodaemun-gu","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea Seoul St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Insular Gran Canarias","city":"Las Palmas","state":"Las Palmas de Gran Canarias","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario de Navarra","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Malaga - Hospital General","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"INCLIVA, Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trial Disclosure & Transparency","phone":"215-832-3750","email":"ClinicalTrialDisclosure@JazzPharma.com"}],"primaryOutcomes":["Confirmed Objective Response Rate (cORR) per RECIST Version 1.1, as assessed by ICR"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","pancreatic-cancer","ovarian-cancer","stomach-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["prescott-arizona","littleton-colorado","fort-myers-florida","orlando-florida","st-petersburg-florida","west-palm-beach-florida","chicago-ridge-illinois","westwood-kansas","detroit-michigan","lake-success-new-york","new-york-new-york","horsham-pennsylvania","knoxville-tennessee","nashville-tennessee","amarillo-texas","dallas-texas","houston-texas","san-antonio-texas","roanoke-virginia","kutaisi-georgia","tbilisi-georgia","suwon-south-korea","hwasun-eup-south-korea","gangnam-gu-south-korea","guro-gu-south-korea","jongno-gu-south-korea","seodaemun-gu-south-korea","seoul-south-korea","las-palmas-spain","pamplona-spain","barcelona-spain","madrid-spain","m-laga-spain","valencia-spain"],"enrichment":{"headline":"Phase 2: testing Zanidatamab for Breast Cancer","inPlainEnglish":"This study wants to measure the how well it works and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.","whoItsFor":["Ages 18 Years to any","HER2 overexpression (IHC 3+) must be determined by a sponsor designated central laboratory","All participants must have adequate tumor sample for submission to allow central HER2 testing","Presence of at least 1 measurable lesion as assessed by Independent Central Review (ICR) based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)","Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Has a life expectancy of at least 3 months, in the opinion of the investigator","Participants with history of treated and stable CNS metastases are eligible, provided the following criteria are met:","Participants also have measurable metastatic disease with HER2 overexpression (IHC 3+) outside the CNS"],"whoShouldSkip":["Has known or suspected leptomeningeal disease and/or untreated brain metastasis","Has uncontrolled or significant cardiovascular disease","Has ongoing toxicity related to prior cancer therapy","Has uncontrolled infection or requiring IV antibiotics, antivirals, or antifungals","Has known Human Immunodeficiency Virus (HIV) infection","Has active hepatitis B or C infection","Has an active SARS-CoV-2 infection"],"whatHappens":"If you join, the listed intervention(s) are Zanidatamab. The registry lists allocation as na. This study wants to measure the how well it works and safety of zanidatamab for the treatment of participants with previously treated solid tumors that have Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemistry (IHC) 3+ overexpression.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.986Z"},{"nctId":"NCT06695897","title":"A Non-interventional Observational Study to Assess Long-term Efficacy and Safety of Dupilumab for the Treatment of Patients (>= 12 Years) With Eosinophilic Esophagitis Under Real-world-conditions in Germany","officialTitle":"Prospective, Non-interventional Observational Study to Characterize Dupilumab in the Long-term Management of Eosinophilic Esophagitis, Safety and Patient Reported Outcomes (Quality of Life) in Clinical Routine","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a longitudinal, observational non-interventional study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual observational period of two years. In addition, data on real-world use patterns and long-term safety data of dupilumab treatment for EoE will be collected.","conditions":["Eosinophilic Esophagitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"}],"enrollment":150,"startDate":"2025-05-28","completionDate":"2027-06-01","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy\n* Patients for whom the treating physician has decided to initiate new treatment with dupilumab for EoE according to EU-SmPC independently from entry in study or for whom treatment with dupilumab for EoE according to EU-SmPC has been started within the last 7 days. The decision to initiate dupilumab treatment is made by the treating physician and the patient according to the patients' medical need and to the standard of best medical practice. This decision is made independently and before inclusion in this NIS.\n* ≥ 12 years of age at baseline visit\n* ≥ 40 kg bodyweight\n* Voluntary study participation and signed written informed consent by patient and parent(s)/guardian(s), if applicable\n\nExclusion Criteria:\n\n* Patients who have a contraindication to dupilumab according to the current EU-SmPC.\n* Patients who have been treated with dupilumab for more than 7 days\n* Any acute or chronic condition that, in the treating physician's opinion, would limit the patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results.\n* Participation in an ongoing interventional or observational study that might, in the treating physician's opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number: 0000009","city":"Aschaffenburg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000014","city":"Augsburg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000001","city":"Dachau","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000012","city":"Erlangen","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000005","city":"Giessen","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000011","city":"Wetzlar","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000013","city":"Osnabrück","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000002","city":"Weyhe-Kirchweyhe","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000007","city":"Bochum","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000003","city":"Burbach","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000006","city":"Guelders","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000010","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000008","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000015","city":"Magdeburg","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0000004","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Descriptive statistical analysis of medical history characteristics","Descriptive statistical analysis of socio-demographic characteristics","Descriptive statistical analysis of disease characteristics"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["aschaffenburg-germany","augsburg-germany","dachau-germany","erlangen-germany","giessen-germany","wetzlar-germany","osnabr-ck-germany","weyhe-kirchweyhe-germany","bochum-germany","burbach-germany","guelders-germany","m-nster-germany","leipzig-germany","magdeburg-germany","berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: testing Dupilumab for Eosinophilic Esophagitis","inPlainEnglish":"This is a longitudinal, watch-and-measure (no experimental treatment required) non-treatment study (NIS) designed to characterize the patient population who receives dupilumab for eosinophilic esophagitis (EoE) treatment in a real-world setting in Germany with respect to their medical history, socio-demographic and disease characteristics, comorbidities (including type 2 inflammatory and atopic conditions), concomitant therapies and prior EoE treatments. Furthermore, this NIS aims to describe the long-term effectiveness of dupilumab for the treatment of EoE as assessed by the treating physician and reported by the patient, and its effect on health-related quality of life (HRQoL) during an individual watch-and-measure (no experimental treatment required) period of two years.","whoItsFor":["Ages 12 Years to any","Patients diagnosed with EoE who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy","≥ 12 years of age at baseline visit"],"whoShouldSkip":["Patients who have a contraindication to dupilumab according to the current EU-SmPC","Patients who have been treated with dupilumab for more than 7 days","Any acute or chronic condition that, in the treating physician's opinion, would limit the patients' ability to complete questionnaires or to participate in this study or impact the interpretation of the results","Participation in an ongoing treatment or watch-and-measure (no experimental treatment required) study that might, in the treating physician's opinion, influence the assessments for the current study (parallel inclusion in another Sanofi-independent registry might be possible if the patient gives consent)","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.709Z"},{"nctId":"NCT06698666","title":"Efficacy of Statins Among Major Depressive Disorder","officialTitle":"The Efficacy of Statins in Management of Major Depression Disorder (MDD) Among Adult Patients Attending the Outpatient Clinics of El Demerdash Hospital.","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ain Shams University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat MDD in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are:\n\nDoes Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( MDD )? What medical problems do participants have when taking drug ABC?\n\nParticipants will:\n\nTake Rosuvastatin 10 mg every day for 3 months Visit the clinic once every 4 weeks for checkups and tests Report any side effects for Rosuvastatin 10 mg and reassess the severity of depression using The Montgomery Asberg Depression Rating Scale (MADRS)","conditions":["Major Depressive Disorder","MDD"],"keywords":["Rosuvastatin","Major depressive disorder","MADRS scale"],"interventions":[{"type":"DRUG","name":"Rosuvastatin 10 mg tablet."},{"type":"DRUG","name":"Sertraline Pill"}],"enrollment":145,"startDate":"2022-10-01","completionDate":"2024-12-04","sex":"ALL","minAge":"20 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* aged between 20 and 45 years;\n* diagnosis of current MDD, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);\n* The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;\n* the ability to give informed consent and to comply with standard procedures;\n* Males and females; and\n* Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated.\n\nExclusion Criteria:\n\n* lifetime or current SCID-I/P diagnosis of a psychotic disorder;\n* lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;\n* acute or unstable systemic medical disorder;\n* inability to comply with the requirements of informed consent or the study protocol;\n* history of intolerance or allergy to study medications;\n* Current pregnancy or breast feeding;\n* Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and\n* Females on Contraception.","locations":[{"facility":"El demerdash hospital","city":"Cairo","state":"Al Abbasia","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Silvana Nader","phone":"01226058776","email":"Slvana_nader@med.asu.edu.eg"}],"primaryOutcomes":["Severity of depression among Participants with MDD as Assessed by MADRS scale"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["cairo-egypt"],"enrichment":{"headline":"Phase 3: testing Rosuvastatin 10 mg tablet. for Major Depressive Disorder","inPlainEnglish":"The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat major depression in adults. It will also learn about the safety of Rosuvastatin 10 mg .The main questions it aims to answer are: Does Rusovastatin lower the score of The Montgomery Asberg Depression Rating Scale (MADRS) among adult participants with Major Depression Disorder ( major depression )?","whoItsFor":["Ages 20 Years to 45 Years","aged between 20 and 45 years;","diagnosis of current major depression, verified using the Structured Clinical Interview for DSM-IV Axis I Disorders, patient version (SCID-I/P);","The Montgomery Asberg Depression Rating Scale (MADRS) score of 7 to 34, indicating mild to moderate depression;","Males and females; and","Stable pharmacological treatment for at least 2 weeks prior to enrolment (changes to medication dose or frequency of therapy excepted) if currently being treated"],"whoShouldSkip":["lifetime or current SCID-I/P diagnosis of a psychotic disorder;","lifetime SCID-I/P diagnosis of bipolar I or II disorder or alcohol dependence;","acute or unstable systemic medical disorder;","history of intolerance or allergy to study medications;","Current pregnancy or breast feeding;","Current regular use of statins, corticosteroids, or any other immunomodulatory agents; and","Females on Contraception"],"whatHappens":"If you join, the listed intervention(s) are Rosuvastatin 10 mg tablet., or Sertraline Pill. The registry lists allocation as randomized. The goal of this clinical trial is to learn if drug Rosuvastatin 10 mg works to treat major depression in adults.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 145 people at Cairo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.119Z"},{"nctId":"NCT06699849","title":"Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis","officialTitle":"A Phase 2, Multicenter, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CSL889 in Adults and Adolescents With Sickle Cell Disease During Vaso-Occlusive Crisis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"CSL Behring","sponsorClass":"INDUSTRY","summary":"This is a phase 2, randomized, multiple-dose, placebo-controlled study designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to evaluate the safety and tolerability of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.","conditions":["Sickle Cell Disease Vaso-occlusive Crisis"],"keywords":["Sickle cell disease","Acute kidney injury","Pharmacokinetics","Acute chest syndrome","Vaso-occlusive crisis","Hemopexin"],"interventions":[{"type":"BIOLOGICAL","name":"CSL889"},{"type":"DRUG","name":"Placebo"}],"enrollment":70,"startDate":"2025-07-10","completionDate":"2027-10-22","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* At the time of informed consent:\n\n  * 18 years of age (adults); or\n  * 12 to less than (\\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \\[IDMC\\])\n* Diagnosed with SCD (any genotype).\n* Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids.\n\nExclusion Criteria:\n\n* VOC pain onset greater than (\\>) 72 hours before administration of first parenteral opioid.\n* Must not have a history of \\> 5 VOCs requiring hospital admission in the past 6 months; or signs and / or symptoms of ACS; or new neurological symptoms suggestive of acute stroke or transient ischemic attack; or any stage (acute kidney injury) AKI; or been discharged from inpatient hospital admission for VOC or other vaso-occlusive event within 14 days before the current presentation.\n* Serum hemoglobin \\< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine.","locations":[{"facility":"Univ. of California, San Francisco Health Care","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medstar Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Golisano Children's Hospital","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Foundation for Sickle Cell Disease","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur M. Blank Hospital-Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois at Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Detroit Medical Center","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health System","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Louis Children's Hospital","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jacobi Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Baskent University School of Medicine","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universitesi","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Universitesi","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical Park Mersin Hospital","city":"Mezitli-Mersin","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Özel Acibadem Adana Hastanesi","city":"Seyhan","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Özel Acibadem Adana Hastanesi","city":"Seyhan/Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mersin Universitesi","city":"Yenişehir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Liverpool University Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Registration Coordinator","phone":"+1 610-878-4697","email":"clinicaltrials@cslbehring.com"}],"primaryOutcomes":["Number of participants with treatment-emergent adverse events (TEAEs)","Percentage of participants with TEAEs","Number of participants with detectable treatment emergent (TE) anti-CSL889 antibodies","Percentage of participants with detectable TE anti-CSL889 antibodies","Time to resolution of VOC (time to discontinuation of parenteral opioids)"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["oakland-california","orange-california","washington-d-c-district-of-columbia","fort-myers-florida","hollywood-florida","atlanta-georgia","chicago-illinois","louisville-kentucky","baltimore-maryland","detroit-michigan","st-louis-missouri","new-york-new-york","the-bronx-new-york","greenville-north-carolina","cincinnati-ohio","columbus-ohio","pittsburgh-pennsylvania","richmond-virginia","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","mezitli-mersin-turkey-t-rkiye","seyhan-turkey-t-rkiye","seyhan-adana-turkey-t-rkiye","yeni-ehir-turkey-t-rkiye","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing CSL889 for Sickle Cell Disease Vaso-occlusive Crisis","inPlainEnglish":"This is a phase 2, randomly assigned, multiple-dose, compared with a dummy treatment study designed to measure the safety, how well it works, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC). The main objectives of the study are to measure the whether it is safe and how hard side effects are to live with of CSL889 in study participants, and to assess how CSL889 affects the time it takes for VOC to resolve in participants with SCD.","whoItsFor":["Ages 12 Years to any","18 years of age (adults); or","12 to less than (\\<) 18 years of age (adolescents, where approved and when enrollment for adolescents has been opened by the sponsor, with the endorsement of the Independent Data Monitoring Committee \\[IDMC\\])","Diagnosed with SCD (any genotype)","Presented at the study site with a new acute VOC necessitating treatment with parenteral opioids"],"whoShouldSkip":["VOC pain onset greater than (\\>) 72 hours before administration of first parenteral opioid","Serum hemoglobin \\< 6 g/dL, serum ferritin ≥ 2000 ng/mL, receiving an approved medication for SCD that has not been on a stable, well-tolerated regimen, currently taking methadone or buprenorphine"],"whatHappens":"If you join, the listed intervention(s) are CSL889, or Placebo. The registry lists allocation as randomized. This is a phase 2, randomly assigned, multiple-dose, compared with a dummy treatment study designed to measure the safety, how well it works, and pharmacokinetics (PK) of CSL889 (human hemopexin) when given intravenously (IV) to adults and adolescents with sickle cell disease (SCD) experiencing vaso-occlusive crises (VOC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at 30 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.845Z"},{"nctId":"NCT06701903","title":"Study of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of ITI-1284 as Monotherapy Treatment in Patients With Generalized Anxiety Disorder Who Have Had Inadequate Response to Generalized Anxiety Disorder Treatment","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of ITI-1284 as monotherapy treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.","conditions":["Generalized Anxiety Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITI-1284 10 mg"},{"type":"DRUG","name":"ITI-1284 20 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":570,"startDate":"2024-11-21","completionDate":"2027-10-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provide written informed consent before the initiation of any study specific procedures;\n* At Screening, meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) diagnostic criteria for moderate or severe GAD (current GAD) as confirmed by the Investigator or Sponsor-approved rater using the Structured Clinical Interview for DSM-5 Clinical Trials Version (SCID-5-CT), and meets all of the following at Screening and Baseline:\n\n  * HAM-A Total score of ≥ 22;\n  * HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;\n  * CGI-S score of ≥ 4;\n* History of inadequate response (\\< 50% improvement in anxiety symptoms as measured by the modified Antidepressant Treatment Response Questionnaire \\[ATRQ\\] for GAD) to at least 2 of the following GAD-approved treatments: paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone taken at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 milligram \\[mg\\], venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and duration (ie, for at least 6 weeks prior to Screening) for the treatment of ongoing GAD symptoms.\n\nExclusion Criteria:\n\n* Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:\n\n  * Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;\n  * Bipolar Disorder;\n* MADRS total score \\> 18 at Screening or Baseline;\n* In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or\n\n  * At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit;\n  * At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;\n  * At Screening or Baseline MADRS Item 10 score ≥ 5; or\n  * The patient is considered to be an imminent danger to him/herself or others based on the assessment of the Investigator;\n* Lifetime history of failure to respond to \\> 3 of the approved treatments for GAD (ie, paroxetine, venlafaxine XR, duloxetine, escitalopram, or buspirone) at an adequate dose (that is, at least a minimum total daily dose of paroxetine 20 mg, venlafaxine XR 75mg, duloxetine 60 mg, escitalopram 10mg, or buspirone 20 mg) and for an adequate duration (ie, at least 6 weeks)","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woodland International Research Group","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woodland Research Northwest","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proscience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leading Edge Research","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Research PRI Encino","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CalNeuro Research","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research Inc","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Neuroscience Research","city":"Sherman Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Research Medical Group","city":"Upland","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sunwise Clinical Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Connecticut Health Center","city":"Farmington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarkis Clinical Trials","city":"Gainesville","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Miami Dade Medical Research Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"iResearch Atlanta LLC","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precise Clinical Research, Inc.","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SPRI Clinical Trials, LLC","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond Behavioral Associates","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sooner Clinical Research","city":"Norman","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban Research Associates","city":"Media","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Relaro Medical Trials","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Sv Dimitar Blagoevgrad","city":"Blagoevgrad","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Lifemed","city":"Kardzhali","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Medconsult-Pleven","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Mentalcare OOD","city":"Plovdiv","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mental Health Center - Rousse","city":"Rousse","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Hera EOOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Intermedica, OOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical center - VAS OOD","city":"Targovishte","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prywatne Gabinety Lekarskie PROMEDICUS","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Przychodnia Srodmiescie SP. z o.o.","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdrowia Alcea","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS","city":"Leszno","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Agnieszka Nowakowska Rudzka Gabinet Lekarski TCP Neuromed","city":"Torun","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Center Dr Dragisa Misovic Dedinje","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Mental Health Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of Serbia 1","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of Serbia","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Special Neuropsychiatric Hospital Kovin","city":"Kovin","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Kragujevac","city":"Kragujevac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center NIS","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specialized Hospital for Neuropsychiatric Diseases Sveti Vracevi","city":"Novi Kneževac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psychiatricka Ambulancia Mentum S.R.O.","city":"Bratislava","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psychiatricka Ambulancia Psycholine S.R.O.","city":"Rimavská Sobota","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdravia R.B.K. S.R.O. Poliklinika Medic Sk","city":"Svidník","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crystal Comfort s.r.o.","city":"Vranov nad Topľou","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Hamilton Anxiety Rating Scale (HAM-A)"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","little-rock-arkansas","rogers-arkansas","culver-city-california","encino-california","los-angeles-california","oceanside-california","sherman-oaks-california","upland-california","walnut-creek-california","farmington-connecticut","gainesville-florida","miami-florida","tampa-florida","decatur-georgia","flowood-mississippi","brooklyn-new-york","buffalo-new-york","staten-island-new-york","columbus-ohio","norman-oklahoma","media-pennsylvania","dallas-texas","bellevue-washington","blagoevgrad-bulgaria","kardzhali-bulgaria","pleven-bulgaria","plovdiv-bulgaria","rousse-bulgaria","sofia-bulgaria","targovishte-bulgaria","bialystok-poland","bydgoszcz-poland","gdansk-poland","leszno-poland","torun-poland","belgrade-serbia","kovin-serbia","kragujevac-serbia","ni-serbia","novi-kne-evac-serbia","bratislava-slovakia","rimavsk-sobota-slovakia","svidn-k-slovakia","vranov-nad-top-ou-slovakia"],"enrichment":{"headline":"Phase 2: testing ITI-1284 10 mg for Generalized Anxiety Disorder","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.","whoItsFor":["Ages 18 Years to any","HAM-A Total score of ≥ 22;","HAM-A Items 1 (anxious mood) and 2 (tension) scores ≥ 2;","CGI-S score of ≥ 4;"],"whoShouldSkip":["Within the patient's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses:","Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;","MADRS total score \\> 18 at Screening or Baseline;","In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or","At Screening, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 of the C-SSRS within 6 months prior to Screening or, at Baseline, the patient scores \"yes\" on Suicidal Ideation Items 4 or 5 since the Screening Visit;","At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening;","At Screening or Baseline MADRS Item 10 score ≥ 5; or"],"whatHappens":"If you join, the listed intervention(s) are ITI-1284 10 mg, ITI-1284 20 mg, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to assess the how well it works, safety, and tolerability of ITI-1284 as this drug alone treatment in patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria for GAD in patients who have had inadequate response to generalized anxiety disorder treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 570 people at 51 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.345Z"},{"nctId":"NCT06705764","title":"Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)","officialTitle":"Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.\n\nA new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.","conditions":["Severe Asthma"],"keywords":["Asthma","Severe Asthma","Asthma Exacerbation","Tezepelumab","Emergency deparment visits for asthma"],"interventions":[{"type":"DRUG","name":"Tezepelumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":100,"startDate":"2026-05-11","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures\n2. Female and/or male aged 18 to 55 years\n3. History of physician-diagnosed asthma\n4. All subjects will have been prescribed high dose inhaled corticosteroid (\\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment.\n5. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months\n6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.\n7. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.\n8. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.\n9. Subject willing and able to comply with study procedures\n\nExclusion Criteria:\n\n1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)\n2. Previous enrolment in the present study\n3. Participation in another clinical study with an investigational product during the last 6 months\n4. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.\n5. Patients who are admitted to hospital at screening.\n6. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.\n7. Known to have tested positive for human immunodeficiency virus\n8. Current smokers with a smoking history of \\> 10 pack-years. Current smokers with a smoking history of \\< 10 pack-years are permitted . Ex-smokers should not have a smoking history \\> 10 pack-years at screening. Participants who use e-cigarettes will also be excluded from the study.\n9. Known history of drug or alcohol abuse within 1 year of screening\n10. Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).\n11. History of QT prolongation associated with other medications that required discontinuation of that medication.\n12. Congenital long QT syndrome.\n13. Creatinine clearance \\<50 ml/min (calculated by Cockcroft-Gault formula, reference Appendix G).\n14. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.\n15. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.","locations":[{"facility":"University of Alberta","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sturgeon Community Hospital","city":"St. Albert","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hannah Anstruther, RRT","phone":"7804923741","email":"hannahanstruther@ualberta.ca"},{"name":"Amy May, RRT","phone":"7804923741","email":"amy.may@ualberta.ca"}],"primaryOutcomes":["Proportion of patients who have moderate and severe exacerbations of asthma"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["edmonton-canada","st-albert-canada"],"enrichment":{"headline":"Phase 4: testing Tezepelumab for Severe Asthma","inPlainEnglish":"Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening.","whoItsFor":["Ages 18 Years to 55 Years","Female and/or male aged 18 to 55 years","History of physician-diagnosed asthma","All subjects will have been prescribed high dose inhaled corticosteroid (\\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment","Documented history of at least one moderate or severe asthma exacerbation in the past 12 months","Negative pregnancy test (urine or serum) for female subjects of childbearing potential","Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug","Subject willing and able to comply with study procedures"],"whoShouldSkip":["Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)","Previous enrolment in the present study","Participation in another clinical study with an investigational product during the last 6 months","Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product","Patients who are admitted to hospital at screening","Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening","Known to have tested positive for human immunodeficiency virus"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab, or Placebo. The registry lists allocation as randomized. Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.870Z"},{"nctId":"NCT06709339","title":"Study to Investigate the Efficacy, Safety and Durability of Faricimab in Caucasian Patients With Polypoidal Choroidal Vasculopathy (MONDEGO)","officialTitle":"A Phase IV, Multicentre, Open-label, Single-arm Study to Investigate the Efficacy, Safety and Durability of Faricimab (RO6867461) in Caucasian Patients With Polypoidal Choroidal Vasculopathy","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Association for Innovation and Biomedical Research on Light and Image","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to assess the efficacy, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is:\n\nTo evaluate the efficacy of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.\n\nParticipants will undergo ophthalmic examination, safety assessment and treatment with faricimab according to a patient specific treat and extend regimen.","conditions":["Polypoidal Choroidal Vasculopathy"],"keywords":["Faricimab","Caucasian patients","PCV","Durability","Safety","Efficacy"],"interventions":[{"type":"DRUG","name":"Faricimab Injection [Vabysmo]"}],"enrollment":120,"startDate":"2025-08-06","completionDate":"2028-08","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"General Inclusion Criteria:\n\nPotential participants are eligible to be included in the study only if all of the following criteria apply:\n\n* Signed ICF\n* Age ≥ 50 years at the time of signing the ICF\n* Caucasian\n* Participants who are able to comply with the study protocol, in the investigator's judgment\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:\n\nFemale participants must remain abstinent or use contraceptive methods with a failure rate of \\< 1% per year, during the treatment period and for at least 3 months after the final dose of faricimab.\n\nA female participant is considered to be of childbearing potential if she is post-menarche, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). Per this definition, a female participant with a tubal ligation is considered to be of childbearing potential. The definition of childbearing potential may be adapted for alignment with local guidelines or regulations.\n\nExamples of contraceptive methods with a failure rate of \\< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n\nThe reliability of sexual abstinence should be evaluated concerning the duration of the clinical trial and the preferred and usual lifestyle of the individual.\n\nPeriodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not adequate methods of contraception.\n\nIf required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local ICF.\n\nOcular Inclusion Criteria for study eye:\n\n* Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis\n* Confirmed diagnosis, by the Reading Centre, of naïve symptomatic macular PCV defined by the following:\n\n  * Active macular polypoidal lesions shown by ICGA AND\n  * Presence of exudative or haemorrhagic features involving the macula as identified by the investigator using multimodal images.\n* BCVA scores of 78-24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters \\[see the BCVA Standard Operational Procedures (SOP) for additional details\\] on study Day 1.\n\nGeneral Exclusion Criteria\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n* Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1\n* Any major illness or major surgical procedure within 1 month before screening\n* Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 (Grade Group of 1) and a stable prostate-specific antigen for ≥ 12 months\n* Continuous use of any medications and treatments indicated below:\n\n  * Systemic anti-VEGF therapy\n  * Systemic drugs known to cause macular oedema (fingolimod, tamoxifen)\n  * Other experimental therapies (except those comprising vitamins and minerals) and therapies that claim to have an effect on macular pathology (e.g., kallidinogenase)\n* Systemic treatment for suspected or active systemic infection on study Day 1\n* Ongoing use of prophylactic antibiotic therapy may be acceptable after discussion with the Medical Monitor.\n* Uncontrolled blood pressure, defined as systolic blood pressure \\> 180 mmHg and/or diastolic blood pressure \\> 100 mmHg while the participant is at rest on study Day 1\n* History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1\n* History of other diseases, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the IMP or that might affect the interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator\n* History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anaesthetic and antimicrobial preparations used by a participant during the study\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab\n\nOcular Exclusion Criteria\n\nPotential participants are excluded from the study if any of the following criteria apply to both eyes:\n\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1\n\nParticipants who meet any of the following ocular criteria for the study eye will be excluded from study entry:\n\n* Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular haemorrhage, IRF, or SRF\n* Retinal pigment epithelial tear involving the macula on study Day 1\n* Diagnosis with or suspected of having narrow-angle glaucoma who have not undergone iridotomy. The inclusion of these patients will be conditional upon prior referral to the relevant specialist for appropriate treatment to enable participation in the study.\n* On FFA/colour fundus photograph (CFP):\n\n  * Subretinal haemorrhage of \\> 4 macular photocoagulation study disc area and/or that involves the fovea\n  * Fibrosis or atrophy of \\> 50% of the total lesion area and/or that involves the fovea\n  * Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study\n  * Current vitreous haemorrhage on study Day 1\n  * Advanced/or uncontrolled glaucoma\n  * Spherical equivalent of refractive error demonstrating more than 8 dioptres of myopia\n* Any prior or concomitant treatment for PCV or other retinal diseases, including, but not restricted to, IVT treatment (e.g., faricimab, anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin PDT, diode laser, transpupillary thermotherapy, or ocular surgical intervention\n* Any cataract surgery or treatment for complications of cataract surgery with steroids or yttrium-aluminum-garnet (YAG) laser capsulotomy within 3 months prior to study Day 1\n* Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy)\n* Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases\n* Continuous use of any medications and treatments indicated below:\n\n  * IVT anti-VEGF agents (other than study-assigned faricimab)\n  * IVT, periocular (subtenon), steroid implants (i.e., Ozurdex®, Illuvien®), or chronic topical ocular corticosteroids (defined as continuous usage for 100 days or longer)\n  * Concurrent use of any macular photocoagulation or PDT with verteporfin Participants who have a non-functioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits will be excluded from study entry.","locations":[{"facility":"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical Retina Service, Operative Unit Ophthalmology - MultiMedica Spa (IRCCSMM)","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ASST-Fatebenefratelli-Sacco P.O.L. Sacco","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Eye Unit, University Hospital Maggiore della Carità","city":"Novara","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia ONLUS,","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Ophthalmology, University Vita Salute - Scientific Institute of San Raffaele","city":"San Raffaele","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Department of Ophthalmology, University of Udine","city":"Udine","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Espaço Médico de Coimbra","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ophthalmology Department, Hospitais Universidade de Coimbra,","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saúde da Região de Leiria, E.P.E.","city":"Leiria","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"almPRIMUM- Serviços de Oftalmologia Médica e Cirúrgica","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Retina e Diabetes Ocular de Lisboa (IRL),","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Serviço de Oftalmologia, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saúde São José","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"ULS-LOD - Hospital Beatriz Ângelo","city":"Loures","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Ophthalmology, Porto Medical School / Hospital S. João","city":"Porto","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Serviço Oftalmologia, Centro Hospitalar Universitário de Santo António, E.P.E.,","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oftalmologia Barraquer","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Vall d'Hebrón Department of Ophthalmology","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Català de Retina (ICR), Clinical Trial Unit","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valles Ophthalmology Research, S.L., Hospital General de Catalunya,","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Department of Ophthalmology, Fundación Jiménez Díaz University Hospital","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oftalmologico Fernandez-Veja","city":"Oviedo","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundación de Oftalmología Médica de la Comunitat Valenciana (Fom)","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust,","city":"Gloucester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Eye Research Centre - St. Paul's Eye Unit, Royal Liverpool University Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Unit, Dep. Ophth., Gloucestershire Hospitals NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICORG - Imperial College Ophthalmologic Research Group","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Southampton NHS Foundation Trust","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolverhampton and Midland Counties Eye Infirmary, New Cross Hospital","city":"Wolverhampton","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joana F Tavares, PhD","phone":"351239480137","email":"mondego@aibili.pt"},{"name":"Liliana C Soares, MsC","phone":"351239480112","email":"lcarvalho@aibili.pt"}],"primaryOutcomes":["Change from Baseline in BCVA in the study eye to Week 40 or 44 or 48"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["faricimab"],"locationSlugs":["milan-italy","novara-italy","roma-italy","san-raffaele-italy","udine-italy","coimbra-portugal","leiria-portugal","lisbon-portugal","loures-portugal","porto-portugal","barcelona-spain","madrid-spain","oviedo-spain","valencia-spain","gloucester-united-kingdom","liverpool-united-kingdom","london-united-kingdom","southampton-united-kingdom","wolverhampton-united-kingdom"],"enrichment":{"headline":"Phase 4: testing Faricimab Injection [Vabysmo] for Polypoidal Choroidal Vasculopathy","inPlainEnglish":"The goal of this clinical trial is to assess the how well it works, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV). The main question it aims to answer is: To measure the how well it works of intravitreal (IVT) injections of faricimab 6 milligrams (mg) on Best Corrected Visual Acuity (BCVA) outcomes in caucasian patients with symptomatic macular PCV.","whoItsFor":["Ages 50 Years to 90 Years","Potential participants are eligible to be included in the study only if all of the following criteria apply:","Age ≥ 50 years at the time of signing the ICF","Participants who are able to comply with the study protocol, in the investigator's judgment","For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined below:","Female participants must remain abstinent or use contraceptive methods with a failure rate of \\< 1% per year, during the treatment period and for at least 3 months after the final dose of faricimab","Examples of contraceptive methods with a failure rate of \\< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices","The reliability of sexual abstinence should be evaluated concerning the duration of the clinical trial and the preferred and usual lifestyle of the individual"],"whoShouldSkip":["Potential participants are excluded from the study if any of the following criteria apply:","Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1","Any major illness or major surgical procedure within 1 month before screening","Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of ≤ 6 (Grade Group of 1) and a stable prostate-specific antigen for ≥ 12 months","Continuous use of any medications and treatments indicated below:","Systemic anti-VEGF therapy","Systemic drugs known to cause macular oedema (fingolimod, tamoxifen)"],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. The goal of this clinical trial is to assess the how well it works, safety and durability of faricimab in caucasian patients with polypoidal choroidal vasculopathy (PCV).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 120 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.134Z"},{"nctId":"NCT06711887","title":"Phase III Extension Study of Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Participants With Lupus Nephritis (SIRIUS-LN Extension)","officialTitle":"An Open-label Extension Study to Assess the Efficacy and Safety of Ianalumab With or Without Study Treatment Withdrawal in Adult Participants With Lupus Nephritis Who Have Completed Study Treatment in the CVAY736K12301 Core Study (SIRIUS-LN Extension)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this up to 6-year extension study is the evaluation of the efficacy and safety\n\n1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on double-blind treatment at the end of the SIRIUS-LN core study, and\n2. of open-label ianalumab 300 mg treatment in patients who, at the end of the SIRIUS-LN core study, were either already receiving ianalumab open-label treatment or did not meet CRR/PRR criteria on double-blind treatment at the end of the SIRIUS-LN core study.","conditions":["Lupus Nephritis"],"keywords":["Lupus Nephritis (LN)","B cell depletion","ianalumab","VAY736"],"interventions":[{"type":"DRUG","name":"Ianalumab"}],"enrollment":348,"startDate":"2025-05-19","completionDate":"2035-08-01","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed informed consent prior to participation in the extension study.\n2. Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on double-blind or open label study treatment.\n\nExclusion Criteria:\n\n1. Use of prohibited therapies\n2. Pregnant or nursing (lactating) women.","locations":[{"facility":"Circuit Clinical","city":"Orchard Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Vitória","state":"Espírito Santo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Belo Horizonte","state":"Minas Gerais","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Recife","state":"Pernambuco","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Santo André","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Shantou","state":"Guangdong","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Liuzhou","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Binzhou","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ningbo","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Olomouc","state":"","country":"Czechia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Grenoble","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guatemala City","state":"Departamento de Guatemala","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Quetzaltenango","state":"Departamento de Quetzaltenango","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Guatemala City","state":"","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tuenmen","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kuala Lumpur","state":"Kuala Lumpur","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sibu","state":"Sarawak","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"León","state":"Guanajuato","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Oaxaca City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Querétaro","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Oradea","state":"Jud Bihor","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Singapore","state":"Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Songkhla","state":"Hat Yai","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Chiang Mai","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ho Chi Minh City","state":"VNM","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"}],"primaryOutcomes":["Cohort 1: Time to renal flare, increase in immunosuppressive medication, or death","Cohort 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["orchard-park-new-york","vit-ria-brazil","salvador-brazil","belo-horizonte-brazil","recife-brazil","santo-andr-brazil","guangzhou-china","shantou-china","shenzhen-china","liuzhou-china","wuhan-china","changchun-china","shenyang-china","binzhou-china","ningbo-china","beijing-china","chongqing-china","shanghai-china","medell-n-colombia","barranquilla-colombia","olomouc-czechia","prague-czechia","grenoble-france","guatemala-city-guatemala","quetzaltenango-guatemala","tuenmen-hong-kong","budapest-hungary","kuala-lumpur-malaysia","sibu-malaysia","le-n-mexico","monterrey-mexico","oaxaca-city-mexico","quer-taro-mexico","oradea-romania","bucharest-romania","singapore-singapore","suwon-south-korea","seoul-south-korea","barcelona-spain","taichung-taiwan","songkhla-thailand","bangkok-thailand","chiang-mai-thailand","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 3: testing Ianalumab for Lupus Nephritis","inPlainEnglish":"The purpose of this up to 6-year extension study is the evaluation of the how well it works and safety 1. after study treatment withdrawal in patients with lupus nephritis (LN) who achieved response (complete renal response \\[CRR\\] or partial renal response \\[PRR\\]) on neither you nor the study doctors know who gets the real treatment treatment at the end of the SIRIUS-LN core study, and 2.","whoItsFor":["Ages 18 Years to 100 Years","Participants must have participated in the SIRIUS-LN core study and must have completed the entire treatment up to Week 144 on neither you nor the study doctors know who gets the real treatment or open label study treatment"],"whoShouldSkip":["Use of prohibited therapies","Pregnant or nursing (lactating) women"],"whatHappens":"If you join, the listed intervention(s) are Ianalumab. The registry lists allocation as randomized. The purpose of this up to 6-year extension study is the evaluation of the how well it works and safety 1.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 348 people at 47 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.269Z"},{"nctId":"NCT06712680","title":"A Phase I/II Study of HYP-6589 Monotherapy in Treating Advanced Solid Tumors and in Combination With Tyrosine Kinase Inhibitors in Treating Patients With Advanced NSCLC Positive for Driver Genes","officialTitle":"A Phase I/II , Open-label, Multi-center, Multi-cohort Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HYP-6589 Monotherapy in Advanced Solid Tumors and Combination With Tyrosine Kinase Inhibitors in Patients With Advanced NSCLC With Target-driven Gene Positivity","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sichuan Huiyu Pharmaceutical Co., Ltd","sponsorClass":"INDUSTRY","summary":"This is a multi-center , open-label, phase 1/2 study to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of HYP-6589 in monotherapy in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.","conditions":["Solid Tumor"],"keywords":[],"interventions":[{"type":"DRUG","name":"Test Product HYP-6589"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":115,"startDate":"2024-11-27","completionDate":"2028-04-10","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily sign an informed consent form, understand the study and be willing and able to follow and complete all trial procedures;\n* ≥18 years old and ≤80 years old, gender: male or female;\n* Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors;\n* At least one measurable lesion (according to RECIST 1.1 version);\n* Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;\n* Life expectancy ≥3 months;\n* Participant must have adequate main organ function;\n* Fertile female patients must have a negative serological pregnancy test within 7 days before the first dosing and be willing to use effective birth control/contraception to prevent pregnancy during the study period up to 6 months after the last dosing of the study. Male patients must agree to have no sperm donation plans and to use effective contraceptive methods during the study period until 6 months after the last dose of the study. Postmenopausal women must have amenorrhea for at least 12 months before they are considered infertile.\n\nExclusion Criteria:\n\n* Participants who have received other investigational drugs or participated in interventional medical device studies within 4 weeks prior to the first administration of the study drug;\n* Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;\n* Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;\n* Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;\n* Participants with clinically uncontrollable hypertension (defined in this protocol as having a systolic blood pressure \\> 150 mmHg and/or a diastolic blood pressure \\> 100 mmHg despite antihypertensive treatment, and which is considered clinically significant by the investigator);\n* Participants who have received allogenic tissue/organ transplants in the past;\n* Participants with active infections deemed inappropriate for entry into the study by the investigator;\n* Participants with uncontrolled third-space effusion requiring clinical intervention;\n* Participants with a history of drug abuse or medical, psychological, or social conditions that may interfere with study participation or impair the assessment of study outcomes;\n* Participants with known gastrointestinal (GI) dysfunction or GI diseases that are likely to significantly affect the absorption or metabolism of oral medications (e.g., dysphagia, active upper gastrointestinal ulcer, intestinal obstruction, nausea, vomiting, and diarrhea of grade 3 or higher that persist despite optimal supportive care within 3 days);\n* Participant whose toxicities from previous anti-cancer therapy have not resolved, defined as toxicity (hair loss excluded) that has not resolved to grade ≤1 (CTCAE 5.0 version, peripheral neuropathy, ≤grade 2; exclusion criteria specified);\n* Female participants who are breastfeeding or have positive urine or blood pregnancy test results during the screening period; female participants who have a planned pregnancy, sperm donation, or egg donation during the study period or within 6 months after the last study drug administration;\n* Known history of hypersensitivity to any of the components of the test formulation.\n* Participants who have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin or squamous cell carcinoma of the skin;","locations":[{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Li Zhang, Doctor","phone":"020-87342288","email":"zhangli@sysucc.org.cn"}],"primaryOutcomes":["Dose Escalation (Part One): Incidence and Nature of Dose-Limiting Toxicity (DLT)","Dose Escalation (Part One): Percentage of participants experiencing treatment-emergent adverse events (TEAEs)","Dose Escalation (Part One): Other safety indicators","Dose Expansion (Part Two): Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["osimertinib"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Test Product HYP-6589 for Solid Tumor","inPlainEnglish":"This is a multi-center , open-label, phase 1/2 study to measure the safety, how well it works, and pharmacokinetic (PK) characteristics of HYP-6589 in this drug alone in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.","whoItsFor":["Ages 18 Years to 80 Years","≥18 years old and ≤80 years old, gender: male or female;","Histological or cytological confirmation of unresectable and/or metastatic advanced solid tumors;","At least one measurable lesion (according to RECIST 1.1 version);","Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1;","Life expectancy ≥3 months;","Participant must have adequate main organ function;"],"whoShouldSkip":["Participants who have received other investigational drugs or participated in treatment medical device studies within 4 weeks prior to the first administration of the study drug;","Participants who have received (attenuated) live vaccines within 4 weeks prior to the first administration of the study drug;","Participants who have undergone major organ surgery (excluding biopsy) within 4 weeks prior to the first administration of the study drug or have experienced significant trauma, or who require elective major organ surgery (excluding biopsy) during the study period;","Participants who, based on computerized tomography (CT) or magnetic resonance imaging (MRI) examinations conducted during the screening period and before radiological assessment, have uncontrolled, unstable, or active central nervous system (CNS) metastases;","Participants who have received allogenic tissue/organ transplants in the past;","Participants with active infections deemed inappropriate for entry into the study by the investigator;","Participants with uncontrolled third-space effusion requiring clinical intervention;"],"whatHappens":"If you join, the listed intervention(s) are Test Product HYP-6589, or Osimertinib. The registry lists allocation as na. This is a multi-center , open-label, phase 1/2 study to measure the safety, how well it works, and pharmacokinetic (PK) characteristics of HYP-6589 in this drug alone in advanced solid tumors and combination with tyrosine kinase inhibitors in patients with advanced NSCLC with target-driven gene positivity.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 115 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.679Z"},{"nctId":"NCT06713616","title":"PCORI Comparative Effectiveness Study-Esketamine (Spravato) vs. Ketamine-Equivalence Study","officialTitle":"Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The purpose of this study is to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following:\n\n* How well the treatment helps with symptoms of depression (effectiveness),\n* How comfortable and willing people are to use the treatment (acceptability), and\n* How well people can deal with any side effects from the treatment (tolerability).\n\nThe study will also examine factors that may predict which treatment works better for certain patients.","conditions":["Depression"],"keywords":[],"interventions":[{"type":"DRUG","name":"Racemic ketamine"},{"type":"DRUG","name":"Spravato (Esketamine)"}],"enrollment":400,"startDate":"2025-01-27","completionDate":"2030-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Adults ages 18 or older\n* Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials\n* Moderate or severe depression based on an initial MADRS score ≥ 25\n* Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation\n* A female participant must be:\n\n  a. Not of childbearing potential\\*, OR b. Of childbearing potential and practicing a highly effective method of contraception (failure rate of \\<1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until 1 week after last dose - the end of relevant systemic exposure. The investigator will evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of drug. Acceptable methods of contraception are: i. combined (estrogen and progestogen containing) hormonal or progestogen-only hormonal contraception associated with inhibition of ovulation (oral, transdermal, or intravaginal) ii. intrauterine device (IUD) iii. intrauterine hormone-releasing system (IUS) iv. bilateral tubal occlusion/ligation v. male partner with a bilateral vasectomy with documented aspermia or a bilateral orchiectomy vi. male or female condom with spermicide, diaphragm, or sponge with spermicide (Note: Use of condom as the sole method of contraception is not considered to be a highly effective method of contraception).\n* A female participant must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study \\* We will consider women to be of childbearing potential if they are within 2 years of menopause (within 3 years since last menstrual period) and have not had a hysterectomy, bilateral oophorectomy, or other definitive surgical intervention.\n\nExclusion Criteria:\n\n* Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)\n* Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis\n* Active or recent (within 12 months) substance use disorder (other than nicotine)\n* Pregnant or lactating women\n* Intracerebral hemorrhage or aneurysmal vascular disease\n* Hypersensitivity to ketamine, esketamine or any of the excipients\n* Known family history of ketamine use disorder\n* Prior known ketamine use disorder as well as subjects for whom study participations will result in more than 8 lifetime exposures to ketamine (e.g., prior exposure to ketamine, prior recreational use with ketamine). Prior esketamine exposure is also exclusionary.\n* Uncontrolled hypertension, as demonstrated by a blood pressure of greater than 145 / 90 at screening visit. (Pre-treatment blood pressure will be permitted to be 150 / 95 to allow for \"whitecoat\" hypertension on treatment visits 1-8.)\n* Known cardiovascular and cerebrovascular conditions that are associated with an increased risk related to ketamine or esketamine administration (including space-occupying CNS lesions). This includes those prospective participants who undergo EKG and are shown to have an abnormality that would put them at increased risk related to treatment.\n* Known condition for which an acute rise in blood pressure would pose a serious risk.\n* Arteriovenous malformation\n* Positive urine toxicology at screening visit, except for substances that are prescribed (i.e., benzodiazepines, stimulants). Given the extended length of time between exposure and negative toxicology screen, a positive screen for THC will not be exclusionary unless the pattern of use and clinical evaluation are indicative of cannabis use disorder. Cannabis used within 24 hours of dosing is exclusionary.\n* Positive alcohol breathalyzer at screening or clinical signs of intoxication\n* The patient is unable to arrange for someone to drive them home after each treatment session; patients who are unwilling to refrain from driving and operating machinery on treatment days until the next day following sleep will be excluded.","locations":[{"facility":"Mood Institute","city":"Milford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"LifeStance Health","city":"Moore","state":"Oklahoma","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Athena Care","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Center for Advanced Psychiatric Treatment","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle NTC","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cindy Voghell","phone":"203-737-4784","email":"Cynthia.Voghell@yale.edu"}],"primaryOutcomes":["Self-Reported Effectiveness"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["milford-connecticut","new-haven-connecticut","atlanta-georgia","ann-arbor-michigan","moore-oklahoma","nashville-tennessee","bellaire-texas","seattle-washington"],"enrichment":{"headline":"Phase 3: testing Racemic ketamine for Depression","inPlainEnglish":"This study wants to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD). The study will look at the following: * How well the treatment helps with symptoms of depression (effectiveness), * How comfortable and willing people are to use the treatment (acceptability), and * How well people can deal with any side effects from the treatment (tolerability).","whoItsFor":["Ages 18 Years to any","Stated willingness to comply with all study procedures and availability for the duration of the study","Adults ages 18 or older","Diagnosis of major depressive disorder that is refractory to two or more antidepressant trials","Moderate or severe depression based on an initial MADRS score ≥ 25","Judged appropriate for ketamine or esketamine by clinician, independent of potential study participation","A female participant must be:"],"whoShouldSkip":["Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)","Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis","Active or recent (within 12 months) substance use disorder (other than nicotine)","Pregnant or lactating women","Intracerebral hemorrhage or aneurysmal vascular disease","Hypersensitivity to ketamine, esketamine or any of the excipients","Known family history of ketamine use disorder"],"whatHappens":"If you join, the listed intervention(s) are Racemic ketamine, or Spravato (Esketamine). The registry lists allocation as randomized. This study wants to compare the relative effectiveness, acceptability, and side effects of ketamine delivered through an IV (a drip into the arm) which is not currently FDA approved for use in the treatment of treatment-resistant depression (TRD) and Esketamine (Spravato®), taken as a nasal spray which has received FDA approval for use in the treatment of treatment-resistant depression (TRD) in the treatment of patients with treatment-resistant depression (TRD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.790Z"},{"nctId":"NCT06714097","title":"Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)","officialTitle":"Application of Digital Twins' Technology in Patients Who Had a Stroke, With Moyamoya Disease and With Cerebral Amyloid Angiopathy (CAA) During the Secondary Prevention Phase: A Proof of Concept Using a Randomized Control Trial (Clinical Study 6, STRATIF-AI Project)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.\n\nThe main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform? Researchers will compare Arm 1, who use the STRATIF-AI app in addition to standard secondary prevention, against Arm 2, who receive standard secondary prevention only, to collect feedback regarding the platform usability.\n\nParticipants in the Arm 1 will:\n\n* Complete cognitive and psychological assessments at the time of the first visit and after six months\n* Follow the indications received from the clinician for standard secondary prevention\n* Use the STRATIF-AI app daily for health management\n* Optionally, purchase wearable devices that connect to the app.\n* Participate in interviews at the six-month mark to share their experiences with the app.\n\nPatients in the Arm 2 will:\n\n* Complete cognitive and psychological assessments at the time of the first visit and after six months\n* Follow the indications received from the clinician for standard secondary prevention","conditions":["Stroke","Moyamoya Disease","Cerebral Amyloid Angiopathy"],"keywords":["stroke","secondary prevention","digital twin","Moyamoya Disease","Cerebral Amyloid Angiopathy"],"interventions":[{"type":"DEVICE","name":"AI"},{"type":"OTHER","name":"healthy dialogue"}],"enrollment":20,"startDate":"2027-01","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* People aged ≥ 18\n* Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021.\n* MOCA total score ≥ 23\n* modified Rankin Scale (mRS) ≤ 2\n* First-time patients at the Besta Institute\n* Ability to sign informed consent\n* Possibility of performing a brain MRI\n\nExclusion Criteria:\n\n* Patients with transient neurological deficits that resolve within an hour and normal brain imaging\n* Patient under legal protection or deprived of liberty by judicial or administrative decision\n* Patient whose follow-up will be impossible\n* Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA)\n* Pregnant patients\n* Known or suspected drug or alcohol abuse","locations":[{"facility":"Fondazione IRCCS Istituto Neurologico Carlo Besta","city":"Milan","state":"Michigan","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Matilde Leonardi, MD","phone":"+39 02 2394 2511","email":"matilde.leonardi@istituto-besta.it"},{"name":"Barbara Maistrello","phone":"+39 02 2394 2521","email":"barbara.maistrello@istituto-besta.it"}],"primaryOutcomes":["Feedback from users"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: AI for Stroke","inPlainEnglish":"The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes. The main questions it aims to answer is: how is the patients' experience regarding the use of the STRATIF-AI platform?","whoItsFor":["Ages 18 Years to any","Clinical and neuroradiological diagnosis of stroke (TAC or MR); diagnosis of CAA based on Boston 2.0 criteria; diagnosis of Moyamoya disease based on diagnostic criteria 2021","MOCA total score ≥ 23","modified Rankin Scale (mRS) ≤ 2","First-time patients at the Besta Institute","Possibility of performing a brain MRI"],"whoShouldSkip":["Patients with transient neurological deficits that resolve within an hour and normal brain imaging","Patient under legal protection or deprived of liberty by judicial or administrative decision","Patient whose follow-up will be impossible","Contraindication to magnetic resonance imaging and/or Digital subtraction angiography (DSA)","Known or suspected drug or alcohol abuse"],"whatHappens":"If you join, the listed intervention(s) are AI, or healthy dialogue. The registry lists allocation as randomized. The goal of this clinical trial is to obtain initial feedback on the implementation of the STRATIF-AI platform and digital twin in the secondary prevention phase in patients with stroke, Moyamoya disease and Cerebral amyloid angiopathy, including adults of both sexes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Milan. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.208Z"},{"nctId":"NCT06717347","title":"A Study to Evaluate Zilovertamab Vedotin (MK-2140) Combination With Rituximab Plus Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated DLBCL (MK-2140-010)","officialTitle":"A Randomized, Open-Label, Multicenter, Phase 3 Study of Zilovertamab Vedotin (MK-2140) in Combination With R-CHP Versus R-CHOP in Participants With Previously Untreated Diffuse Large B-Cell Lymphoma (DLBCL) (waveLINE-010)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.","conditions":["Diffuse Large B-Cell Lymphoma"],"keywords":["Lymphoma, Large B-Cell, Diffuse"],"interventions":[{"type":"BIOLOGICAL","name":"Zilovertamab vedotin"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Doxorubicin"},{"type":"BIOLOGICAL","name":"Rituximab Biosimilar"},{"type":"DRUG","name":"Prednisone"},{"type":"DRUG","name":"Prednisolone"},{"type":"DRUG","name":"Vincristine"},{"type":"DRUG","name":"Rescue medication"},{"type":"DRUG","name":"Methylprednisolone"}],"enrollment":1046,"startDate":"2025-01-27","completionDate":"2029-07-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues\n* Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale\n* Has received no prior treatment for their DLBCL\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization\n* Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n* Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n* Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\n* Has a history of transformation of indolent disease to DLBCL\n* Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n* Has Ann Arbor Stage I DLBCL\n* Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\\<6 months prior to enrollment), myocardial infarction (\\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n* Has clinically significant pericardial or pleural effusion\n* Has ongoing Grade \\>1 peripheral neuropathy\n* Has a demyelinating form of Charcot-Marie-Tooth disease\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has ongoing corticosteroid therapy\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) lymphoma\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* Has active infection requiring systemic therapy\n* Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection\n* Has history of allogeneic tissue/solid organ transplant","locations":[{"facility":"USA Mitchell Cancer Institute ( Site 0173)","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center ( Site 0165)","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center - University Medical Center Phoenix ( Site 0167)","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Arizona Cancer Center - North Campus ( Site 0124)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation-Oncology ( Site 0168)","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MemorialCare Health System - Long Beach Medical Center ( Site 9559)","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Blood and Specialty Clinic ( Site 0109)","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center ( Site 0115)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Hematology Oncology Associates ( Site 0131)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lutheran Hospital - Cancer Centers of Colorado ( Site 0180)","city":"Golden","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clermont Oncology Center ( Site 0182)","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partner ( Site 0157)","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute ( Site 0169)","city":"Ocoee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Florida Hematology and Oncology Center ( Site 0172)","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital ( Site 0134)","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Cancer & Blood Center, LLC ( Site 0141)","city":"Athens","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope and Healing Cancer Services ( Site 9511)","city":"Hinsdale","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edward Cancer Center ( Site 0197)","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois ( Site 0152)","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Wayne Medical Oncology and Hematology ( Site 0149)","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Cancer Center ( Site 0108)","city":"Topeka","state":"Kansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Kentucky ( Site 0106)","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0163)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Owensboro Medical Health System ( Site 0195)","city":"Owensboro","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0184)","city":"Alexandria","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Oncology Partners, P.A. ( Site 0185)","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Oncology Hematology (MOH) ( Site 8004)","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9545)","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute ( Site 0174)","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health ( Site 0130)","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Michigan University - Saginaw ( Site 0198)","city":"Saginaw","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Mississippi Medical Center ( Site 0161)","city":"Jackson","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Circuit Clinical - SSM Health Cancer Care DePaul ( Site 0166)","city":"Bridgeton","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Missouri Hospital ( Site 0175)","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Truman Medical Center ( Site 0122)","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology and Hematology Associates ( Site 9546)","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0178)","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OptumCare Cancer Care ( Site 0121)","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Comprehensive Cancer Centers of Nevada ( Site 0113)","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists ( Site 9582)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Jersey Cancer Care ( Site 7002)","city":"Belleville","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Oncology Hematology, P.C. 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(PFS)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["mobile-alabama","gilbert-arizona","phoenix-arizona","tucson-arizona","fullerton-california","long-beach-california","los-alamitos-california","los-angeles-california","san-francisco-california","golden-colorado","clermont-florida","hialeah-florida","ocoee-florida","orange-city-florida","tampa-florida","athens-georgia","hinsdale-illinois","naperville-illinois","ofallon-illinois","fort-wayne-indiana","topeka-kansas","lexington-kentucky","louisville-kentucky","owensboro-kentucky","alexandria-louisiana","bethesda-maryland","columbia-maryland","ann-arbor-michigan","detroit-michigan","grand-rapids-michigan","saginaw-michigan","jackson-mississippi","bridgeton-missouri","columbia-missouri","kansas-city-missouri","springfield-missouri","billings-montana","las-vegas-nevada","reno-nevada","belleville-new-jersey","albany-new-york","new-york-new-york","shirley-new-york","greenville-north-carolina","fargo-north-dakota","cincinnati-ohio","eugene-oregon","portland-oregon","greenville-south-carolina","sioux-falls-south-dakota","knoxville-tennessee","nashville-tennessee","dallas-texas","houston-texas","lubbock-texas","the-woodlands-texas","charlottesville-virginia","hampton-virginia","richmond-virginia","roanoke-virginia","olympia-washington","madison-wisconsin","caba-argentina","mar-del-plata-argentina","pilar-argentina","buenos-aires-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","san-juan-argentina","townsville-australia","adelaide-australia","ballarat-australia","melbourne-australia","perth-australia","mechelen-belgium","mons-belgium","cascavel-brazil","curitiba-brazil","natal-brazil","florian-polis-brazil","ribeir-o-preto-brazil","s-o-carlos-brazil","sjrp-brazil","s-o-paulo-brazil","edmonton-canada","halifax-canada","hamilton-canada","oshawa-canada","toronto-canada","concepci-n-chile","la-serena-chile","valdivia-chile","santiago-chile","vi-a-del-mar-chile","hefei-china","beijing-china","chongqing-china","fuzhou-china","xiamen-china","guangzhou-china","nanning-china","guiyang-china","wuhan-china","nantong-china","nanchang-china","changchun-china","jinan-china","linyi-china","shanghai-china","taiyuan-china","xian-china","chengdu-china","tianjin-china","kunming-china","hangzhou-china","medell-n-colombia","bogot-colombia","monter-a-colombia","pereira-colombia","cali-colombia","aarhus-denmark","herning-denmark","aalborg-denmark","odense-denmark","nice-france","la-rochelle-france","dijon-france","la-tronche-france","limoges-france","metz-france","dunkirk-france","clermont-ferrand-france","bayonne-france","rouen-france","toulon-france","avignon-france","la-roche-sur-yon-france","saint-cloud-france","athens-greece","alexandroupoli-greece","guatemala-city-guatemala","hong-kong-hong-kong","budapest-hungary","debrecen-hungary","ny-regyh-za-hungary","szeksz-rd-hungary","haifa-israel","jerusalem-israel","tel-aviv-israel","tiberias-israel","monza-italy","rionero-in-vulture-italy","palermo-italy","candiolo-italy","ancona-italy","brescia-italy","milan-italy","novara-italy","ravenna-italy","roma-italy","nagoya-japan","kashiwa-japan","matsuyama-japan","kobe-japan","kanazawa-japan","isehara-japan","sendai-japan","sakai-japan","iruma-gun-japan","bunkyo-japan","ch-japan","chiba-japan","fukuoka-japan","hiroshima-japan","kyoto-japan","miyazaki-japan","okayama-japan","osaka-japan","yamagata-japan","kota-kinabalu-malaysia","kuching-malaysia","miri-malaysia","petaling-jaya-malaysia","selangor-darul-ehsan-malaysia","torre-n-mexico","pachuca-mexico","mexico-city-mexico","morelia-mexico","monterrey-mexico","oaxaca-city-mexico","dordrecht-netherlands","leiden-netherlands","amersfoort-netherlands","chiclayo-peru","surquillo-peru","lima-peru","wroclaw-poland","lublin-poland","warsaw-poland","s-upsk-poland","gliwice-poland","katowice-poland","olsztyn-poland","braga-portugal","lisbon-portugal","porto-portugal","san-juan-puerto-rico","yauco-puerto-rico","bucharest-romania","cluj-napoca-romania","brasov-romania","sibiu-romania","singapore-singapore","pretoria-south-africa","cape-town-south-africa","goyang-si-south-korea","busan-south-korea","daejeon-south-korea","seoul-south-korea","seville-spain","lhospitalet-de-llobregat-spain","barakaldo-spain","las-palmas-de-gran-canaria-spain","majadahonda-spain","gij-n-spain","alicante-spain","barcelona-spain","madrid-spain","m-laga-spain","zaragoza-spain","baden-switzerland","sankt-gallen-switzerland","bellinzona-switzerland","lugano-switzerland","taoyuan-city-taiwan","kaohsiung-city-taiwan","tainan-taiwan","taipei-taiwan","bangkoknoi-thailand","pathumwan-thailand","muang-thailand","korfez-mahallesi-turkey-t-rkiye","suleymanpasa-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","istanbul-turkey-t-rkiye","cherkasy-ukraine","ivano-frankivsk-ukraine","khmelnytskiy-ukraine","lviv-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 3: testing Zilovertamab vedotin for Diffuse Large B-Cell Lymphoma","inPlainEnglish":"This study wants to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.","whoItsFor":["Ages 18 Years to any","Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, based on local testing according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues","Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale","Has received no prior treatment for their DLBCL","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization","Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)","Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)","Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization"],"whoShouldSkip":["Has a history of transformation of indolent disease to DLBCL","Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma","Has Ann Arbor Stage I DLBCL","Has clinically significant pericardial or pleural effusion","Has ongoing Grade \\>1 peripheral neuropathy","Has a demyelinating form of Charcot-Marie-Tooth disease","HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease"],"whatHappens":"If you join, the listed intervention(s) are Zilovertamab vedotin, Rituximab, or Cyclophosphamide. The registry lists allocation as randomized. This study wants to evaluate if zilovertamab vedotin with standard treatment can help people live longer without the cancer growing or spreading than people who receive standard treatment alone.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,046 people at 288 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.155Z"},{"nctId":"NCT06719778","title":"Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease","officialTitle":"Prospective Interventional Study to Evaluate the Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Universität Duisburg-Essen","sponsorClass":"OTHER","summary":"The goal of this prospective interventional study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms.\n\nThe main questions the study aims to answer are:\n\n* whether a food-induced intestinal barrier disorder in Crohn's disease patients can be detected by endoscopy using confocal laser endomicroscopy (CLE) and a causal relationship with certain foods can be established.\n* whether a change in diet or a targeted elimination diet can restore the defective integrity of the intestinal barrier detected by CLE.\n* to examine whether a targeted avoidance of a food that was identified by CLE to trigger intestinal barrier disruption leads to a relevant improvement in symptoms, quality of life and disease activity in patients with Crohn's disease.\n\nParticipants will undergo a two-stage nutritional therapy concept based on a two-week inpatient integrative medicinal lifestyle modification program that comprises nutritional therapy, stress management strategies, mind-body medicine, herbal medicine and exercise:\n\n* Initially, participants learn how to employ the comprehensive lifestyle modification concept and receive nutritional training on a mostly vegetarian Mediterranean wholefood diet.\n* In a first stabilization phase, lasting for 3 months, participants independently apply the taught Mediterranean diet and use strategies from the comprehensive lifestyle modification program.\n* In a second elimination phase, lasting for another 3 months, participants additionally avoid the particular food that was identified by CLE to induce an intestinal barrier defect.\n\nCrohn's disease patients will:\n\n* initially receive a clinically indicated endoscopy with CLE and food challenge to examine whether a food-induced intestinal barrier disorder is present\n* return to the clinic for an optional endoscopy with CLE and food challenge after the first (stabilization) phase as well as the second (elimination) phase\n* answer questionnaires at study start as well as after the first and the second study phase to analyze their quality of life, the severity of their symptoms and their disease activity\n* give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during regular inpatient sampling at study start as well as after the first and the second study phase\n* document their intake of food and their symptoms in an App-based diary throughout the study participation","conditions":["Crohn's Disease"],"keywords":["integrative medicine","lifestyle modification","intestinal barrier","Mediterranean diet","inflammatory bowel disease","Confocal Laser Endomicroscopy","Crohn Disease","microbiome","nutrition","irritable bowel"],"interventions":[{"type":"OTHER","name":"Two-stage nutritional therapy concept"}],"enrollment":30,"startDate":"2025-03-04","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* age more than 18 years\n* Crohn's Disease for at least 6 months (date of initial diagnosis)\n* with suspected food-induced symptoms or irritable bowel syndrome-like symptoms (fulfils IBS-Rom-IV criteria) for at least 3 months with moderate to severe symptom severity\n* stable IBD-specific medication dosage for at least 3 months \\[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\\].\n* inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment\n* clinical indication and performance of an initial esophagogastroduodenoscopy with confocal laser endomicroscopy with detection of a food-induced intestinal barrier disorder\n* signed informed consent form\n\nExclusion Criteria:\n\n* severe flare of Crohn's disease\n* artificial intestinal outlet\n* IgE-mediated type 1 allergy to CLE-tested foods (egg white, soy, milk, yeast, wheat)\n* macroscopic inflammation of the duodenum (detected via endoscopy)\n* pregnancy or breastfeeding\n* chronic alcohol or drug abuse\n* treatment with antibiotics within one month before the start of the study\n* Acute or chronic infectious, inflammatory or autoimmune intestinal diseases (such as coeliac disease, Whipples disease, lambliasis, eosinophilia, ulcerative colitis, infectious enterocolitis) or other organs (such as chronic hepatitis, autoimmune hepatitis, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)\n* malignant diseases affecting internal organs within the last 5 years (such as colorectal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, breast cancer)\n* severe mental disorders that impair the participant's ability to understand or follow the study protocol (e.g. uncontrolled schizophrenia, severe bipolar disorder, severe depression)\n* inability to give written consent or follow study protocols\n* participation in another therapeutic study within the last 30 days (except health services research)","locations":[{"facility":"Sozialstiftung Bamberg","city":"Bamberg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Angelika Schmalzl, Dr. rer. nat.","phone":"0049 951 503 11650","email":"FIGN@sozialstiftung-bamberg.de"}],"primaryOutcomes":["Improvement of the integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["bamberg-germany"],"enrichment":{"headline":"Not a traditional drug phase: Two-stage nutritional therapy concept for Crohn's Disease","inPlainEnglish":"The goal of this prospective treatment study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms. The main questions the study aims to answer are: * whether a food-induced intestinal barrier disorder in Crohn's disease patients can be detected by endoscopy using confocal laser endomicroscopy (CLE) and a causal relationship with certain foods can be established.","whoItsFor":["Ages 18 Years to any","age more than 18 years","Crohn's Disease for at least 6 months (date of initial diagnosis)","with suspected food-induced symptoms or irritable bowel syndrome-like symptoms (fulfils IBS-Rom-IV criteria) for at least 3 months with moderate to severe symptom severity","stable IBD-specific medication dosage for at least 3 months \\[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\\]","inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment","clinical indication and performance of an initial esophagogastroduodenoscopy with confocal laser endomicroscopy with detection of a food-induced intestinal barrier disorder"],"whoShouldSkip":["severe flare of Crohn's disease","artificial intestinal outlet","IgE-mediated type 1 allergy to CLE-tested foods (egg white, soy, milk, yeast, wheat)","macroscopic inflammation of the duodenum (detected via endoscopy)","pregnancy or breastfeeding","chronic alcohol or drug abuse","treatment with antibiotics within one month before the start of the study"],"whatHappens":"If you join, the listed intervention(s) are Two-stage nutritional therapy concept. The registry lists allocation as na. The goal of this prospective treatment study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Bamberg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.434Z"},{"nctId":"NCT06721949","title":"Taurine Supplementation in Long COVID","officialTitle":"Taurine Supplementation as a Novel Therapeutic Approach for Neurocognitive Symptoms in Long COVID","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection. This condition, known as Long COVID (LC) or sometimes referred to as Post-COVID Condition (PCC) or post-acute sequelae of COVID-19, has emerged as a complex multisystemic condition and challenging health issue, affecting approximately 10% of COVID-19 patients. Various symptoms characterize LC, including fatigue, sleep disturbances, cognitive impairment, and mood disturbances. Some of the symptoms are shared with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) - a condition marked by debilitating fatigue and a host of other symptoms without precise biomarkers or objective tests for diagnosis. Effective LC treatments remain elusive and LC patients continue to grapple with persistent symptoms that significantly impact their quality of life. Given the lack of effective treatments, it is imperative to explore novel therapeutic approaches that may alleviate the suffering of this patient population.","conditions":["Long COVID"],"keywords":["Taurine","COVID","Long COVID","randomized trial","neurocognitive symptoms"],"interventions":[{"type":"DRUG","name":"Taurine"},{"type":"DRUG","name":"Placebo"}],"enrollment":300,"startDate":"2025-11-18","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Positive COVID-19 test by nasopharyngeal swab RT-PCR test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019, and at least 3 months prior to randomization.\n3. If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks).\n4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms.\n5. Lingering symptoms from COVID-19 present at the time of randomization.\n6. Individuals of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use at least one highly effective method of contraception while on study treatment. Highly effective methods of contraception must be discussed and approved by the overseeing Investigator (refer to Section 5 Contraception of the Master Protocol, and Section 13.1.2 of this protocol).\n7. Must be able to provide informed consent and both willing and able to comply with study requirements.\n8. Medications prescribed for treating fatigue or cognition have been discontinued for four weeks prior to enrolment and randomization. These include sildenafil, modafinil (Provigil), or armodafinil (Nuvigil), guanfacine, N-acetyl cysteine, and stimulant medications used for attention-deficit hyperactivity disorder (ADHD).\n\nExclusion Criteria:\n\n1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19.\n2. Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital.\n3. Contraindications to the study intervention.\n4. Currently already on study intervention(s).\n5. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted).\n6. Currently pregnant or breastfeeding.\n7. The participant is currently enrolled in another clinical trial to treat neurocognitive symptoms in LC.","locations":[{"facility":"University of Alberta Hospital, Kaye Edmonton Clinic","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Women's Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de recherches cliniques de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lawrence Richer, MD, MSc","phone":"780-492-0943","email":"lricher@ualberta.ca"},{"name":"Ellen Morrison, PhD","phone":"","email":"taurineLC@ualberta.ca"}],"primaryOutcomes":["Mean change in Modified Fatigue Impact Scale (MFIS) from baseline to three months","Mean change in the ratio of the Trail-Making Tests A & B in the TestMyBrain cognitive testing battery from baseline to three months."],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["edmonton-canada","vancouver-canada","toronto-canada","montreal-canada","sherbrooke-canada"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Taurine for Long COVID","inPlainEnglish":"The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity. While many individuals recover from the acute phase of the infection, a significant proportion continue to experience persistent and debilitating symptoms long after the initial SARS-CoV-2 infection.","whoItsFor":["Ages 18 Years to any","If participants have treatable symptoms, they should have had a stable regimen of treatment prior to entering the study (i.e. started treatment for at least 4 weeks)","Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive testing or the date of first symptoms","Lingering symptoms from COVID-19 present at the time of randomization"],"whoShouldSkip":["Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19","Current end-organ failure, organ transplantation, or current hospitalization in an acute care hospital","Contraindications to the study intervention","Currently already on study intervention(s)","Co-enrolment in another treatment trial (co-enrolment in an watch-and-measure (no experimental treatment required) study is permitted)","Currently pregnant or breastfeeding","The participant is currently enrolled in another clinical trial to treat neurocognitive symptoms in LC"],"whatHappens":"If you join, the listed intervention(s) are Taurine, or Placebo. The registry lists allocation as randomized. The COVID-19 pandemic has swept across the globe, affecting millions of individuals with varying degrees of severity.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 300 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.240Z"},{"nctId":"NCT06725277","title":"The OBSERVE Protocol","officialTitle":"Comparative Effectiveness of Racemic Ketamine Versus Esketamine (Spravato®) for Depression: The OBSERVE Protocol","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Yale University","sponsorClass":"OTHER","summary":"This observational protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches.\n\nThis 5-year, 6-site study will enroll 450 total patients. The sites will comprise 3 academic medical centers and 3 community psychiatric practices.","conditions":["Major Depression Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Spravato"},{"type":"DRUG","name":"IV Ketamine"}],"enrollment":450,"startDate":"2024-01-21","completionDate":"2029-12","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Recently started treatment (within 75 days of screening visit) with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features and having appropriate baseline measures collected before starting treatment. These patients are referred to as treatment-continuing subjects.\n\n   OR\n2. Scheduled to receive standard clinical treatment with IV ketamine or Spravato® as prescribed by a clinician for the treatment of moderate to severe (based on an initial MADRS score ≥ 25) TRD (refractory to two or more antidepressant trials) without psychotic features. These patients are referred to as treatment-initiating subjects.\n\n   In addition, in order to be eligible, an individual must meet all of the following additional criteria:\n3. Adult ages 18 or older\n4. Provision of signed and dated informed consent form prior to any study procedures\n5. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)\n2. Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis\n3. Active or recent (within 12 months) substance use disorder (other than nicotine)","locations":[{"facility":"Mood Institute","city":"Milford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"LifeStance Health","city":"Moore","state":"Oklahoma","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Athena Care","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Center for Advanced Psychiatric Treatment","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle NTC","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cindy Voghell","phone":"203-737-4784","email":"cynthia.voghell@yale.edu"}],"primaryOutcomes":["TSQM-9"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["milford-connecticut","new-haven-connecticut","atlanta-georgia","ann-arbor-michigan","moore-oklahoma","nashville-tennessee","bellaire-texas","seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: testing Spravato for Major Depression Disorder","inPlainEnglish":"This watch-and-measure (no experimental treatment required) protocol is intended to provide long-term follow-up data on patients initiating or continuing treatment with either Spravato® or IV ketamine. This can provide us information on the patient acceptability and satisfaction, patterns of use, long-term effectiveness, and safety of the two approaches.","whoItsFor":["In order to be eligible to participate in this study, an individual must meet the following criteria:","In addition, in order to be eligible, an individual must meet all of the following additional criteria:","Adult ages 18 or older","Stated willingness to comply with all study procedures and availability for the duration of the study"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Diagnosis of bipolar disorder or psychotic disorder (i.e., schizophrenia, schizoaffective disorder)","Other psychiatric comorbidities are permitted so long as depression is the predominant diagnosis","Active or recent (within 12 months) substance use disorder (other than nicotine)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 450 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.790Z"},{"nctId":"NCT06726577","title":"TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial Evaluating the Safety, Efficacy, and Pharmacokinetic Characteristics of TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Talengen Institute of Life Sciences, Shenzhen, P.R. China.","sponsorClass":"OTHER","summary":"This trial adopts a multicenter, randomized, double-blind, placebo-controlled parallel design.\n\nThis experiment is divided into two groups: the experimental drug group and the placebo group. Successful participants will be randomly assigned to the two groups, with an expected enrollment of 60 participants. There will be 30 participants in the experimental drug group and 30 participants in the placebo group. During the treatment period, the experimental drug group received intravenous injections of 0.5mL/kg TP04HN106 each time; The placebo group received intravenous injections of 0.5mL/kg of saline each time. During the extension period, all subjects received intravenous injection of 0.5mL/kg TP04HN106. In the experiment, all subjects received Liraglutide tablets as the standard baseline treatment.\n\nThe subjects who were successfully screened in the experiment were enrolled in sequence, and the safety, tolerability, efficacy, and pharmacokinetic characteristics of the experimental drug were evaluated after administration. The entire trial includes a screening period of 1 week, a treatment period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), an extension period of 12 weeks (including 3 treatment cycles, each treatment cycle of 4 weeks), and a follow-up period of 4 weeks. In addition, some subjects underwent a 1-week single dose PK study before the start of the treatment period; In addition, during the first treatment cycle of the treatment period, some subjects were selected for multiple dosing PK studies.\n\nWe plan to conduct a single dose PK study among 12 subjects, with 6 subjects in the experimental group and 6 subjects in the control group; Multiple dose PK studies were conducted among 12 subjects, with 6 subjects in the experimental group and 6 sujects in the control group. It is not allowed for the same subject to participate in both single dose and multiple dose PK studies simultaneously.\n\nThe 1st to 12th subjects planned to be enrolled in the trial will undergo a single dose PK study. After the first dose, venous blood will be collected from the 12 subjects according to the blood sample collection requirements, and their PK characteristics will be evaluated. The observation period for single dose administration is one week. After completing the final blood sample collection and safety assessment, the subjects enter the treatment period, extension period, and follow-up period.\n\nThe 13th to 24th subjects planned to be enrolled in the trial will undergo multiple dose PK studies. These 12 subjects will have their venous blood collected according to the blood sample collection requirements during the first treatment cycle of the treatment period, and their PK characteristics will be evaluated. After completing the treatment period, the subjects will enter the extension period and follow-up period.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"TP04HN106"},{"type":"DRUG","name":"Saline"}],"enrollment":60,"startDate":"2026-06-04","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;\n2. Age ≥18 years old, male or female;\n3. The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;\n4. Pre-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;\n5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.\n\nExclusion Criteria:\n\n1. The subject is known to be allergic to the investigational drug or its excipients;\n2. The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease of the heart, lung, liver, or brain, or is accompanied by a failure of different organs (for patients with respiratory failure, only patients diagnosed as type I or type II respiratory failure are excluded);\n3. The subject has a major mental illness or cognitive dysfunction;\n4. Patients with a history of secondary or above surgery within one month before the screening period;\n5. The subjects participated in other clinical studies within 1 month;\n6. The subjects are pregnant or lactating women;\n7. Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.\n\n   \\-","locations":[{"facility":"The First Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Doctor Li, Dr","phone":"0086-89290018","email":"jnl@talengen-pharma.com"}],"primaryOutcomes":["Amyotrophic Lateral Sclerosis Rating Scale (ALSFRS-R)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["suzhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing TP04HN106 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"This trial adopts a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment parallel design. This experiment is divided into two groups: the experimental drug group and the dummy treatment (placebo) group.","whoItsFor":["Ages 18 Years to any","Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;","Age ≥18 years old, male or female;","The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;","Pre-randomly assigned subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;"],"whoShouldSkip":["The subject is known to be allergic to the investigational drug or its excipients;","The subject has a major mental illness or cognitive dysfunction;","Patients with a history of secondary or above surgery within one month before the screening period;","The subjects participated in other clinical studies within 1 month;","The subjects are pregnant or lactating women;","Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion"],"whatHappens":"If you join, the listed intervention(s) are TP04HN106, or Saline. The registry lists allocation as randomized. This trial adopts a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment parallel design.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Suzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.618Z"},{"nctId":"NCT06728436","title":"Testing the Effects of a Text Message Caregiver Support Intervention for Latinos","officialTitle":"Testing the Effects of a Text Message Caregiver Support Intervention for Latinos","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Kansas Medical Center","sponsorClass":"OTHER","summary":"The goal of this randomized clinical trial it to test the efficacy of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos.\n\nResearchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .\n\nParticipants will receive a variety of text messages, from automatic to keyword-drive, regarding ADRD education, social support, self-care, ADRD care management, and behavioral symptoms. Participants will also complete measures regarding depressive symptoms, coping, behavioral symptoms, and preparedness for caregiving.","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"CuidaTEXT"}],"enrollment":288,"startDate":"2025-02-17","completionDate":"2029-05","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Over the age of 18\n* Spanish and English-speaking people who identify as Latino\n* Reports providing hands-on care for a relative who has been given a clinical or research ADRD diagnosis and has an Eight-item Informant Interview to Differentiate Aging and Dementia (AD-8) screening score ≥2, indicating cognitive impairment\n* Has a score of 7 or higher on the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)\n* Self-reports being able to read and write\n* Owns a cell phone with a flat fee, and uses it at least weekly for texting.\n\nExclusion Criteria:\n\n* Participation in another wellbeing-related clinical trial\n* Cohabitation with another participant in the CuidaTEXT R01 Study\n* Participants who provide care for a person with ADRD already cared for by another participant in the CuidaTEXT R01 study\n* Participant plans to move to another country within seven months","locations":[{"facility":"University of Kansas Medical Center","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rachel Ruiz","phone":"913-945-5052","email":"rruiz3@kumc.edu"},{"name":"Jaime Perales Puchalt, PhD, MPH","phone":"913-588-3716","email":"jperales@kumc.edu"}],"primaryOutcomes":["Change in caregiver depressive symptoms"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["fairway-kansas"],"enrichment":{"headline":"Not a traditional drug phase: CuidaTEXT for Alzheimer Disease","inPlainEnglish":"The goal of this randomly assigned clinical trial it to test the how well it works of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos. Researchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .","whoItsFor":["Ages 18 Years to 100 Years","Spanish and English-speaking people who identify as Latino","Reports providing hands-on care for a relative who has been given a clinical or research ADRD diagnosis and has an Eight-item Informant Interview to Differentiate Aging and Dementia (AD-8) screening score ≥2, indicating cognitive impairment","Has a score of 7 or higher on the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)","Self-reports being able to read and write","Owns a cell phone with a flat fee, and uses it at least weekly for texting"],"whoShouldSkip":["Participation in another wellbeing-related clinical trial","Cohabitation with another participant in the CuidaTEXT R01 Study","Participants who provide care for a person with ADRD already cared for by another participant in the CuidaTEXT R01 study","Participant plans to move to another country within seven months"],"whatHappens":"If you join, the listed intervention(s) are CuidaTEXT. The registry lists allocation as randomized. The goal of this randomly assigned clinical trial it to test the how well it works of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 288 people at Fairway. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.322Z"},{"nctId":"NCT06730126","title":"Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients","officialTitle":"A Phase 2a Study of the ITK Inhibitor Soquelitinib to Reduce Lymphoproliferation and Improve Cytopenias in Autoimmune Lymphoproliferative Syndrome (ALPS)-FAS Patients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nAutoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes. This can lead to an enlarged spleen and lymph nodes. Current treatments for ALPS can have many adverse effects. Better treatments for ALPS are needed.\n\nObjective:\n\nTo test a study drug (soquelitinib) in people with ALPS.\n\nEligibility:\n\nPeople aged 16 years and older with ALPS.\n\nDesign:\n\nParticipants will have 8 clinic visits and 6 remote visits within 1 year.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. Some may have tests of their lung function.\n\nSoquelitinib is a tablet taken by mouth twice a day. Participants will record their doses and any symptoms on a paper or online form.\n\nBlood tests and other procedures will be repeated during study visits. Three visits will include imaging scans. Participants will lie on a table that slides through a doughnut-shaped machine while X-rays capture pictures of the inside of their body.\n\nSome participants may be able to remain in the study for a second year....","conditions":["Autoimmune Lymphoproliferative Syndrome"],"keywords":["Autoimmune Lymphoproliferative Syndrome","Fas","Hypersplenism","Lymphoproliferation","Interleukin-2 Inducible T-cell Kinase","Soquelitinib","Targeted Treatment"],"interventions":[{"type":"DRUG","name":"Soquelitinib"}],"enrollment":15,"startDate":"2025-03-10","completionDate":"2026-12-01","sex":"ALL","minAge":"16 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study and to re-enroll, an individual must meet all the following criteria:\n\n1. Aged \\>= 16 years.\n2. Able to provide informed consent (for ages \\>= 18 years) or has a parent(s) or guardian(s) who can provide permission to participate on their behalf (for ages \\<18 years).\n3. Has a documented diagnosis of ALPS-FAS.\n4. Has clinical evidence of active disease, defined as at least one enlarged lymph node and/or enlarged spleen.\n5. If currently on corticosteroid therapy, then dose is less than 20 mg/day (prednisone equivalent) and has been stable for at least 4 weeks.\n6. For participants to be seen at the NIH CC, co-enrolled on NIH protocol 93-I-0063.\n7. Participants who can become pregnant or who can impregnate their partner must agree to either remain sexually abstinent or use two highly effective methods of contraception when engaging in sexual activities that can result in pregnancy, beginning 28 days before baseline until 3 months after the last dose. One method must be a barrier (eg, internal or external condom, cervical cap, or diaphragm). The second method may be any of the following:\n\n7a. Oral contraceptive pill or hormonal patch or ring.\n\n7b. Parenteral hormonal contraceptive implant.\n\n7c. Intrauterine device.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation or re-enrollment in this study:\n\n1. Profound grade 3 or 4 cytopenias that cannot be improved with immunomodulatory treatments prior to enrolling in the clinical trial and starting the study drug. Per investigator discretion, individuals on a single agent may be included if the dose is stable for 12 weeks at screening and is not expected to confer additive toxicity.\n2. Renal impairment, defined as serum creatinine \\>1.5 mg/dL (or 133 micromol/L) or estimated glomerular filtration rate \\<60 mL/min/1.73 m\\^2.\n3. Liver impairment, defined as bilirubin, alanine aminotransferase, or aspartate aminotransferase greater than 2.5 times the upper limit of normal.\n4. History of EBV-associated lymphoma.\n5. Active EBV infection with EBV load \\>300 copies/mL.\n6. Tuberculosis infection (active or latent) or undergoing tuberculosis treatment.\n7. Infection with HIV or hepatitis B or C.\n8. Current other invasive or systemic fungal, bacterial, or viral infection requiring therapy.\n9. History of opportunistic infection within the previous 180 days.\n10. History of invasive malignancy that required systemic therapy within the last 3 years.\n11. Current use of moderate or strong cytochrome P450 isozyme (CYP)3A inhibitors or inducers that cannot be stopped before day 0.\n12. Current use of P-glycoprotein (P-gp) inhibitors that cannot be stopped before day 0.\n13. Known hypersensitivity or contraindication to CT contrast agent.\n14. Pregnant or breastfeeding.\n15. Any condition that, in the opinion of the study team contraindicates participation in this study.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Children's Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alanvin D Orpia, R.N.","phone":"(240) 550-3663","email":"alanvin.orpia@nih.gov"},{"name":"V. Koneti Rao, M.D.","phone":"(301) 496-6502","email":"kr191c@nih.gov"}],"primaryOutcomes":["Reduction of spleen volume or target lymph node volume by 25% from baseline to day 90, assessed by CT or PET/CT scan."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["bethesda-maryland","philadelphia-pennsylvania","houston-texas"],"enrichment":{"headline":"Phase 2: testing Soquelitinib for Autoimmune Lymphoproliferative Syndrome","inPlainEnglish":"Background: Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene. In ALPS, the body stores too many germ-fighting cells called lymphocytes.","whoItsFor":["Ages 16 Years to 120 Years","To be eligible to participate in this study and to re-enroll, an individual must meet all the following criteria:","Has a documented diagnosis of ALPS-FAS","Has clinical evidence of active disease, defined as at least one enlarged lymph node and/or enlarged spleen","If currently on corticosteroid therapy, then dose is less than 20 mg/day (prednisone equivalent) and has been stable for at least 4 weeks","For participants to be seen at the NIH CC, co-enrolled on NIH protocol 93-I-0063","7a. Oral contraceptive pill or hormonal patch or ring","7b. Parenteral hormonal contraceptive implant"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation or re-enrollment in this study:","Renal impairment, defined as serum creatinine \\>1.5 mg/dL (or 133 micromol/L) or estimated glomerular filtration rate \\<60 mL/min/1.73 m\\^2","Liver impairment, defined as bilirubin, alanine aminotransferase, or aspartate aminotransferase greater than 2.5 times the upper limit of normal","History of EBV-associated lymphoma","Active EBV infection with EBV load \\>300 copies/mL","Tuberculosis infection (active or latent) or undergoing tuberculosis treatment","Infection with HIV or hepatitis B or C"],"whatHappens":"If you join, the listed intervention(s) are Soquelitinib. The registry lists allocation as na. Background: Autoimmune lymphoproliferative syndrome (ALPS) is a rare disorder of the immune system caused by a mutation in the FAS gene.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 15 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.123Z"},{"nctId":"NCT06731504","title":"HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT","officialTitle":"A Pilot Trial of Abatacept Based Graft-Versus-Host Disease Prophylaxis Following Omidubicel Hematopoietic Cell Transplantation","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"This study is a single-center, non-randomized, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT.\n\nTarget enrollment is 10 participants. Subjects are adults with a diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing. Patients will be followed for a total of 18 months and will have research blood draws and Abatacept pharmacokinetics, as well as standard of care assessments that will be reviewed for this study.\n\nIt is estimated that 36 months of accrual will be necessary to enroll the targeted sample size with an accrual rate of approximately 1 participant every 3 months. Accrual will be reported by race, ethnicity, gender, and age. Descriptive analyses are planned given the sample size.","conditions":["Hematologic Malignancy"],"keywords":[],"interventions":[{"type":"DRUG","name":"Abatacept"}],"enrollment":10,"startDate":"2025-11-12","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. A diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing\n2. Adult patients (≥18 at the time of enrollment)\n3. Adequate organ function for transplant defined as:\n\n   1. Left ventricular ejection fraction ≥ 40%;\n   2. DLCO, FEV1, FVC \\> 50% predicted;\n   3. Total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis, and ALT, AST, and alkaline phosphatase all \\< 5 x upper limit of normal (ULN);\n   4. Serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance \\> 40 mL/min/1.73m2;\n   5. Karnofsky performance score ≥ 70; and\n   6. If applicable, \\> 6 months since a previous autologous transplant.\n4. Female patients (unless postmenopausal or surgically sterilized) and male patients (even if surgically sterilized) must agree to practice two effective methods of contraception at the same time, or agree to completely abstain from heterosexual intercourse from the time of signing informed consent through 100 days post-transplant. Fertility preservation method will be left to treating physician's discretion.\n\nExclusion Criteria:\n\n1. Patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material\n2. Presence of a donor-specific antibodies with MFI \\>2000\n3. Uncontrolled bacterial, fungal or viral infection\n4. Treatment with any other investigational medical product (medications without any known FDA approved indication) needs to be discussed with the PI for patient eligibility.","locations":[{"facility":"Duke University Health System","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sanghee Hong, MD","phone":"9196848694","email":"sanghee.hong@duke.edu"},{"name":"Lauren Hill","phone":"9196682369","email":"lauren.hill@duke.edu"}],"primaryOutcomes":["Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by frequency of adverse events.","Safety of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by severity of adverse events.","Feasibility of ABA/Tac/MMF GVHD prophylaxis following omidubicel HCT as evaluated by number of subjects who receive minimum dose of ABA."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Early phase 1: testing Abatacept for Hematologic Malignancy","inPlainEnglish":"This study is a single-center, non-randomly assigned, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis. The primary objective is to assess the safety and feasibility of abatacept/tacrolimus/mycophenolate mofetil GVHD prophylaxis following omidubicel HCT.","whoItsFor":["Ages 18 Years to any","A diagnosis of hematologic malignancy with an available cord blood unit for omidubicel product manufacturing","Adult patients (≥18 at the time of enrollment)","Adequate organ function for transplant defined as:","Left ventricular ejection fraction ≥ 40%;","DLCO, FEV1, FVC \\> 50% predicted;","Total bilirubin ≤ 2.5 mg/dL except for patients with Gilbert's syndrome or hemolysis, and ALT, AST, and alkaline phosphatase all \\< 5 x upper limit of normal (ULN);","Serum creatinine within normal range, or if serum creatinine outside normal range, must have measured or estimated creatinine clearance \\> 40 mL/min/1.73m2;"],"whoShouldSkip":["Patients with known sensitivity to dimethyl sulfoxide, dextran 40, gentamicin, human serum albumin or bovine material","Presence of a donor-specific antibodies with MFI \\>2000","Uncontrolled bacterial, fungal or viral infection","Treatment with any other investigational medical product (medications without any known FDA approved indication) needs to be discussed with the PI for patient eligibility"],"whatHappens":"If you join, the listed intervention(s) are Abatacept. The registry lists allocation as na. This study is a single-center, non-randomly assigned, single-arm pilot trial of omidubicel hematopoietic stem cell transplantation (HCT) for hematologic malignancies with myeloablative conditioning chemotherapy of physician's choice followed by abatacept/tacrolimus/mycophenolate mofetil (ABA/Tac/MMF) graft-versus-host disease (GVHD) prophylaxis.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 10 people at Durham. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.641Z"},{"nctId":"NCT06733376","title":"Evaluating Evidenced Based Options for PTSD Treatment","officialTitle":"Evaluating Evidence Based Options for Initial PTSD Treatment Non-Responders","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Rush University Medical Center","sponsorClass":"OTHER","summary":"This study will look at:\n\nHow practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.\n\nThe goal is to improve personalized care by:\n\nIdentifying factors that might predict how someone will respond to a second treatment.\n\nCreating a simple tool to spot people who might not respond to treatment early, so they can start a different option sooner.\n\nThe findings will help improve PTSD care by offering better follow-up treatments and matching patients with the approach that works best for them.","conditions":["PTSD - Post Traumatic Stress Disorder"],"keywords":["ptsd treatment"],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Processing Therapy"},{"type":"BEHAVIORAL","name":"Prolonged Exposure"},{"type":"BEHAVIORAL","name":"Skills Training for Affective and Interpersonal Regulation"}],"enrollment":400,"startDate":"2025-10-06","completionDate":"2029-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Are 18 years or older\n* Are fluent in English\n* Have experienced a Criterion A traumatic event during their lifetime\n* Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5\n* Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)\n* Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study\n\nExclusion Criteria:\n\n* The index traumatic event occurred in the past month\n* They are currently suicidal or homicidal (i.e., current plan and imminent intent)\n* They have unmanaged psychosis or mania\n* They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment\n* They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)\n* They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment\n* They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year\n* They have an active substance use disorder (within the past three months) that would require immediate medical observation if substance was abruptly discontinued\n* They are involved with current legal actions related to their index trauma\n* They have a visual or auditory impairment that would prevent them from fully participating in study activities\n* They, at the time of consent, appear to have extenuating life circumstances (i.e., unstable housing, no internet access, etc.) which, in the judgement of the study team, could affect the ability to deliver interventions with fidelity","locations":[{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Philip Held, PhD","phone":"312-942-1423","email":"philip_held@rush.edu"},{"name":"Sarah Pridgen, MA","phone":"312-563-0577","email":"sarah_pridgen@rush.edu"}],"primaryOutcomes":["PTSD Checklist for DSM-5 (PCL-5)","Clinician Administered PTSD Scale for DSM-5"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: Cognitive Processing Therapy for PTSD - Post Traumatic Stress Disorder","inPlainEnglish":"This study will look at: How practical it is to offer another round of proven therapy. How effective different therapy options are for people who didn't respond to the first treatment.","whoItsFor":["Ages 18 Years to any","Are 18 years or older","Are fluent in English","Have experienced a Criterion A traumatic event during their lifetime","Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM-5","Are interested in receiving evidence-based treatment for PTSD and able to attend 10 therapy sessions over the course of 2 weeks (10 days) and could possibly attend another 10 sessions of a subsequent treatment (additional CPT sessions, PE, or STAIR)","Are willing and able to complete self-report measures and clinician-rated assessments at multiple timepoints over the course of the study"],"whoShouldSkip":["The index traumatic event occurred in the past month","They are currently suicidal or homicidal (i.e., current plan and imminent intent)","They have unmanaged psychosis or mania","They have not been on a stable dose of psychotropic medication for at least one month at the time of the baseline assessment","They have completed an evidence-based cognitive behavioral PTSD treatment in the past three months or are currently engaged in an evidence-based PTSD treatment (CPT, PE)","They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in treatment","They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year"],"whatHappens":"If you join, the listed intervention(s) are Cognitive Processing Therapy, Prolonged Exposure, or Skills Training for Affective and Interpersonal Regulation. The registry lists allocation as randomized. This study will look at: How practical it is to offer another round of proven therapy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.412Z"},{"nctId":"NCT06733922","title":"ELIOS - Investigational Biomarkers to Track Disease Modification in Active RRMS","officialTitle":"Exploratory Evaluation of Novel Investigational Eye Movement Biomarkers to Track Ofatumumab Treatment Response in Canadian Patients With Active Relapsing-Remitting Multiple Sclerosis (ELIOS)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.","conditions":["Relapsing Remitting Multiple Sclerosis (RRMS)"],"keywords":["Ofatumumab","Eye Movement Biomarkers (EMB)","Patient-Reported Outcomes (PRO)","Active Relapsing-Remitting MS (RRMS)","Real-World, Neurofilament Light Chain (NfL)","Digital, Eye-Tracking"],"interventions":[{"type":"DEVICE","name":"ETNATM-ProgMS"}],"enrollment":224,"startDate":"2024-11-27","completionDate":"2028-11-30","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria\n\nPatients eligible for inclusion in the study must fulfill all of the following criteria:\n\n1. Adult patients who are prescribed ofatumumab as part of routine clinical care as per the PM but who have not yet received their first dose. The decision to prescribe ofatumumab must be made prior to and independent of study participation.\n2. Patients or their legally authorized representatives who sign the Institutional Review Boards/Independent Ethics Committee (IRB/IEC)-approved informed consent form.\n3. Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment.\n4. Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2.\n5. Patients who can provide blood samples.\n6. Patients who can understand written and spoken Canadian English or French.\n7. Patients who have sufficient corrected visual acuity to allow for accurate reading of the on-screen visual task instructions, in the judgement of the Investigator. If a relapse temporarily affects a patient's corrected visual acuity, the Baseline Visit may be postponed until the patient can accurately read the on-screen visual task instructions, if deemed acceptable by the Investigator and the patient.\n8. Patients with a confirmed diagnosis of MS with no signs of progressive increase in physical disability independent of relapse activity within the past six months, as assessed by a physician.\n\nExclusion criteria\n\nIn order to ensure that the study population will be representative of all eligible patients, no additional exclusions may be applied by the Investigator. Patients meeting any of the following criteria are not eligible for inclusion in this study:\n\n1. Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome.\n2. Any disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures.\n3. Pregnant or nursing (lactating) women.\n4. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while taking ofatumumab and for six months after stopping medication. Effective contraception methods include:\n\n   * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception\n   * Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to enrollment. In case of oophorectomy alone, the reproductive status of the woman must be confirmed by follow-up hormone level assessment\n   * Male sterilization at least six months prior to enrollment. For female participants on the study, the vasectomized male partner should be the sole partner for that participant\n   * Use of oral (estrogen and progesterone), injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, or other forms of hormonal contraception that have comparable efficacy (failure rate \\<1%) such as hormone vaginal ring or transdermal hormone contraception\n   * Use of barrier methods of contraception (male or female condom, occlusive cap, diaphragm or cervical/vault caps)\n   * In case of use of hormonal contraception women participants should have been stable on the same method for a minimum of three months before taking study treatment.\n   * If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF.\n   * Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate history of vasomotor symptoms). Women participants are considered not of child-bearing potential if they are post-menopausal or have had bilateral tubal ligation, surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks prior to first dose of study treatment on study. In the case of oophorectomy alone, a woman is not considered to be of child-bearing potential only when the reproductive status has been confirmed by follow-up hormone level assessment.\n5. Patients with hypersensitivity to ofatumumab or to any ingredient in the formulation, active hepatitis B virus, progressive multifocal leukoencephalopathy (PML), severe active infections, in a severely immunocompromised state or with known active malignancies.\n6. Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or with immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency).\n7. Patients who are using other investigational drugs within 30 days prior to or at the Baseline Visit, or within a period corresponding to five elimination half-lives, whichever is longer, or who are using other investigational drugs for which the expected pharmacodynamic effect has not returned to baseline.\n8. Contraindication or inability to undergo regular testing (e.g., MRI, blood tests) as per standard of care.\n9. Patients who have been treated with cladribine or with alemtuzumab at any time within the 12 months prior to the Baseline Visit.\n10. Patients who have had any prior exposure to anti-CD20 B-cell therapy (i.e., ocrelizumab, ofatumumab) or natalizumab.\n11. Medical history or evidence of health issues that, in the opinion of the Investigator, may affect movements and oculomotor control.","locations":[{"facility":"Novartis Investigative Site","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Burnaby","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"St. John's","state":"Newfoundland and Labrador","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["1- Change Eye Movement Biomarkers (EMB)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ofatumumab"],"locationSlugs":["calgary-canada","edmonton-canada","burnaby-canada","vancouver-canada","st-johns-canada","halifax-canada","ottawa-canada","montreal-canada","qu-bec-canada","sherbrooke-canada"],"enrichment":{"headline":"Phase 4: ETNATM-ProgMS for Relapsing Remitting Multiple Sclerosis (RRMS)","inPlainEnglish":"The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab). To that end, the study will use the patented investigational, Eye Tracking Neurological Assessment (ETNA-ProgMS) SaMD (v1.0.11 or later), which has not yet received Health Canada approval, to reliably and accurately track eye movements with precision.","whoItsFor":["Ages 18 Years to 99 Years","Patients eligible for inclusion in the study must fulfill all of the following criteria:","Adult patients who are prescribed ofatumumab as part of routine clinical care as per the PM but who have not yet received their first dose. The decision to prescribe ofatumumab must be made prior to and independent of study participation","Patients who meet the EDSS score range of 0 up to 7 at the time of screening and enrollment for ofatumumab treatment","Patients with a diagnosis of active RRMS according to the 2017 Revised McDonald criteria2","Patients who can provide blood samples","Patients who can understand written and spoken Canadian English or French","Patients with a confirmed diagnosis of MS with no signs of progressive increase in physical disability independent of relapse activity within the past six months, as assessed by a physician"],"whoShouldSkip":["In order to ensure that the study population will be representative of all eligible patients, no additional exclusions may be applied by the Investigator. Patients meeting any of the following criteria are not eligible for inclusion in this study:","Patients with primary progressive MS, secondary progressive MS without disease activity, clinically isolated syndrome, or radiologically isolated syndrome","Any disease or condition that could interfere with participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures","Pregnant or nursing (lactating) women","Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while taking ofatumumab and for six months after stopping medication. Effective contraception methods include:","Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception","Male sterilization at least six months prior to enrollment. For female participants on the study, the vasectomized male partner should be the sole partner for that participant"],"whatHappens":"If you join, the listed intervention(s) are ETNATM-ProgMS. The registry lists allocation as na. The exploratory ELIOS study aims to assess the value of novel investigational Eye Movement Biomarkers (EMBs) in tracking disease-related changes among a real-world cohort of Canadian patients with active RRMS, within the context of disease-modifying treatment (i.e., ofatumumab).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 224 people at 10 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.275Z"},{"nctId":"NCT06733935","title":"A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)","officialTitle":"A Phase 1/2 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects With Immune-Mediated Diseases","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Nkarta, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomized dose escalation and dose expansion basket study to determine the safety and tolerability of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.","conditions":["Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Antineutrophil Cytoplasmic Antibody-Associated Vasculitis","Rheumatoid Arthritis"],"keywords":["CD19","CAR","Allogeneic","NKX019","Natural Killer Cells","Interleukin-15","IL-15","Cell Therapy","Immunotherapy","Adoptive cell therapy","Scleroderma","Myositis","AAV","Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Antineutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis","Ntrust-2","Rheumatoid Arthritis"],"interventions":[{"type":"DRUG","name":"NKX019"},{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Cyclophosphamide"}],"enrollment":240,"startDate":"2024-11-04","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"General Inclusion Criteria:\n\n* Age ≥18 and ≤75 years\n* Signed informed consent and ability to adhere to the study visit schedule and comply with other protocol requirements\n* Women of childbearing potential must have negative pregnancy tests at screening and baseline and agree to abstinence or acceptable birth control from 2 weeks before the first dose through 1 year after the last dose\n* Participants taking corticosteroids must be at a stable prednisone (or equivalent) dose ≤20 mg/day for ≥14 days before Screening\n* Participants on immunosuppressives or immunomodulators (other than corticosteroids) must have stable dosing for ≥4 weeks before Screening\n* eGFR (2021 CKD-EPI equation) ≥45 mL/min/1.73 m² at screening\n\nFor Subjects with Systemic Sclerosis (SSc):\n\n* Meets the 2013 ACR/EULAR classification criteria for SSc\n* Severe skin involvement defined as modified Rodnan skin score (mRSS ≥30) or active skin disease (mRSS ≥15 with, within the prior 6 months, an mRSS increase ≥3 units, 1 new body area with ≥2 mRSS units, or 2 new body areas with ≥1 mRSS unit each), OR moderate-to-severe interstitial lung disease (ILD) on HRCT with FVC \\<70% predicted or DLCO \\<70% predicted (or ILD on HRCT with progression per protocol-defined criteria)\n* 10 years or less since the first non-Raynaud's sign or symptom\n* Inadequate response or intolerance to at least one prior treatment, including cyclophosphamide, methotrexate, MMF/mycophenolic acid, nintedanib, rituximab, or tocilizumab\n\nFor Subjects with Idiopathic Inflammatory Myopathies (IIM):\n\n* Diagnosis of IIM per the 2017 ACR/EULAR Classification Criteria\n* One positive myositis antibody (historical)\n* Disease activity defined as manual muscle testing (MMT-8) score \\<136/150\n* Creatine kinase or aldolase ≥1.5×ULN and Clinician Global Assessment ≥2 cm, with evidence of active myositis (MRI, EMG, or biopsy within 6 months) or MDAAT Global Extramuscular Activity Score ≥2 cm; participants with DM, JDM, or ASyS may qualify with CK/aldolase \\<1.5×ULN if Clinician Global Assessment ≥2 cm and either of the above is met or CDASI ≥15, pending discussion with the medical monitor\n* Inadequate response to ≥3 months of at least 2 immunosuppressive therapies (including glucocorticoids)\n\nFor Subjects with ANCA-Associated Vasculitis (AAV):\n\n* Meets the 2022 ACR/EULAR classification criteria for Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)\n* Relapsed or refractory AAV despite repeated immunosuppressive treatment, or requiring prolonged/repeated unacceptable glucocorticoid doses to maintain disease control\n* Positive anti-proteinase-3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) at screening\n* Meets BVAS version 3 activity threshold (≥1 major item, ≥3 other items, or ≥2 renal items)\n\nFor Subjects with Rheumatoid Arthritis (RA):\n\n* Documented diagnosis of RA, meeting the 2010 ACR/EULAR classification criteria\n* Rheumatoid Factor (RF) or Anti-Citrullinated Protein Antibody (ACPA) positive\n* CRP \\>3 mg/L\n* Inadequate response, defined as failure to achieve a clinically meaningful improvement (eg, ACR50 response or DAS28 remaining \\>3.2) after ≥12 weeks of therapy with: ≥1 conventional synthetic DMARD (eg, methotrexate, leflunomide, sulfasalazine, hydroxychloroquine) plus either: ≥2 biologic DMARDs with distinct mechanisms of action (eg, TNF inhibitors, abatacept, anti-IL-6/IL-6R, rituximab) or ≥1 biologic DMARD and ≥1 targeted synthetic DMARD (eg, a JAK inhibitor), having failed no more than 4 biologics or targeted synthetic DMARDs with unique mechanisms of action\n* Minimum of 6 swollen joint counts (based on the 66-joint count) and 6 tender joint counts (based on the 68-joint count) at Screening (28-joint counts used at Baseline and thereafter)\n\nGeneral Exclusion Criteria:\n\n* Currently requiring or expected to require renal dialysis during the study\n* Previous solid organ or hematopoietic cell transplant, or planned transplant during the study treatment period\n* Congenital or acquired immunodeficiency resulting in severe infection, or receiving chronic immunoglobulin replacement therapy\n* Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥3× the upper limit of normal\n* Pulmonary comorbidity (eg, COPD or asthma requiring daily oral steroids), resting hypoxemia (\\<92% oxygen saturation on room air), or significant smoking history (\\>10 pack-years) with active pulmonary disease\n* ILD requiring supplemental oxygen therapy, FVC \\<45% predicted, or DLCO ≤40% predicted at screening\n* White blood cell count \\<3,000/mm³, hemoglobin levels ≤9 g/dL, absolute neutrophil count ≤1,500/mm³, platelets ≤100,000/mm³, or blood transfusion within 60 days before lymphodepletion (LD)\n* Major cardiac disease, abnormalities, or interventions (eg, uncontrolled angina, myocardial infarction within 12 weeks, prior coronary artery bypass graft surgery, ≥Class III congestive heart failure (CHF), significantly decreased ejection fraction (EF) ≤40%, prolongation of the QT interval corrected for heart rate (QTc) \\>480 msec, or a ≥Grade 2 thrombotic/embolic event within 12 weeks of the first dose\n* Active bleeding disorder\n* Overlapping autoimmune condition for which the condition or its treatment may affect study assessments or outcomes\n* Pregnancy, breastfeeding, or, if of childbearing potential, not using adequate contraception\n* Current infection requiring active systemic anti-infective therapy, or a recent acute infection treated systemically within 30 days of planned LD; participants who are asymptomatic and being treated for a non-systemic infection (eg, urinary tract infection) are not excluded on this basis and may be eligible after discussion with the Sponsor Medical Monitor\n* History of positive human immunodeficiency virus (HIV) antibody or PCR test, or a positive test at screening, Hepatitis B or C positive at screening, or active or latent tuberculosis requiring suppressive therapy\n* Major surgery within 28 days before the first dose of NKX019, or any surgery from which the participant has not recovered or has ongoing complications\n* Malignancy within 5 years of screening, except treated basal/squamous cell carcinoma or treated cervical dysplasia with a normal repeat Pap test\n* Prior cellular therapy, including mesenchymal, CAR-T, or CAR-NK cells or CD19 directed therapy\n* Central nervous system (CNS) comorbidity, including history or presence of seizure disorder, cerebrovascular ischemia/hemorrhage (including transient ischemic attack), dementia, cerebellar disease, or any immune-mediated disease with CNS involvement within 90 days before the first dose of NKX019, or evidence of CNS-related autoimmune manifestations within 1 year before screening (eg, aseptic meningitis, ataxia, CNS vasculitis, cranial neuropathy, demyelinating syndrome, optic neuritis, psychosis, seizures, or transverse myelitis)\n* Any other acute or chronic medical or psychiatric condition, or laboratory abnormality, that in the Investigator's or Sponsor's opinion would increase the risk of participation, interfere with informed consent, study compliance, or interpretation of results, or make the participant inappropriate for the study, including clinically significant drug or alcohol abuse within 2 years before screening\n* Current participation in another interventional clinical trial; participants may be considered after an investigational product washout of 5 half-lives or 30 days, whichever is longer\n* Known hypersensitivity or contraindication to the study treatment, including lymphodepletion, or to other components such as human serum albumin or dimethyl sulfoxide\n\nSSc Exclusion Criteria:\n\n* Moderate-to-severe pulmonary arterial hypertension (PAH) on right heart catheterization requiring PAH-specific treatment (well-controlled mild PAH is permitted)\n* Gastrointestinal dysmotility requiring total parenteral nutrition\n* Renal crisis or pericardial tamponade within 6 months before enrollment\n* Current gangrene of a digit\n* Extensive, advanced fibrotic ILD on screening HRCT involving \\>50% of the total lung parenchyma, or other HRCT findings indicative of end-stage fibrotic lung disease with limited potentially reversible parenchyma\n\nIIM Exclusion Criteria:\n\n* Severe chronic proximal muscle involvement on MRI (≥15% fibro-fatty replacement or ≥15% muscle atrophy in core muscle groups, or a combined extent \\>30%)\n* MMT-8 ≤80\n* Muscular inflammation or myopathy due to another cause (eg, inclusion body myositis, cancer-associated myositis, amyloid myopathy, muscular dystrophy, metabolic myopathies, or overlap myositis other than with Sjögren's syndrome)\n* Generalized, severe musculoskeletal or neuro-muscular condition other than IIM\n* Immune-mediated necrotizing myopathy\n* Clinically significant calcinosis (cutaneous or subcutaneous) that, in the Investigator's judgment, could confound assessment of muscle strength, physical function, or cutaneous disease\n\nAAV Exclusion Criteria:\n\n* Alveolar hemorrhage requiring invasive pulmonary ventilation support\n* Required dialysis or plasma exchange within 12 weeks before screening\n* Any other known disease that may interfere with assessments, including eosinophilic GPA (Churg-Strauss), anti-glomerular basement membrane disease, systemic lupus erythematosus, IgA vasculitis (Henoch-Schönlein), rheumatoid vasculitis, or cryoglobulinemic vasculitis","locations":[{"facility":"Nkarta Investigational Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Summit","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nkarta Investigational Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nkarta Central Contact","phone":"Only use email","email":"clinicaltrials@nkartatx.com"}],"primaryOutcomes":["Incidence of Dose-limiting toxicities (DLTs) [Safety and Tolerability]","Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["los-angeles-california","plantation-florida","tampa-florida","fairway-kansas","ann-arbor-michigan","minneapolis-minnesota","hackensack-new-jersey","summit-new-jersey","new-york-new-york","syracuse-new-york","charlotte-north-carolina","dallas-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing NKX019 for Systemic Sclerosis","inPlainEnglish":"This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomly assigned dose escalation and dose expansion basket study to determine the whether it is safe and how hard side effects are to live with of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.","whoItsFor":["Ages 18 Years to 75 Years","Age ≥18 and ≤75 years","Women of childbearing potential must have negative pregnancy tests at screening and baseline and agree to abstinence or acceptable birth control from 2 weeks before the first dose through 1 year after the last dose","Participants taking corticosteroids must be at a stable prednisone (or equivalent) dose ≤20 mg/day for ≥14 days before Screening","Participants on immunosuppressives or immunomodulators (other than corticosteroids) must have stable dosing for ≥4 weeks before Screening","eGFR (2021 CKD-EPI equation) ≥45 mL/min/1.73 m² at screening","For Subjects with Systemic Sclerosis (SSc):","Meets the 2013 ACR/EULAR classification criteria for SSc"],"whoShouldSkip":["Currently requiring or expected to require renal dialysis during the study","Previous solid organ or hematopoietic cell transplant, or planned transplant during the study treatment period","Congenital or acquired immunodeficiency resulting in severe infection, or receiving chronic immunoglobulin replacement therapy","Liver disease or dysfunction, including cirrhosis and/or bilirubin ≥3× the upper limit of normal","Pulmonary comorbidity (eg, COPD or asthma requiring daily oral steroids), resting hypoxemia (\\<92% oxygen saturation on room air), or significant smoking history (\\>10 pack-years) with active pulmonary disease","ILD requiring supplemental oxygen therapy, FVC \\<45% predicted, or DLCO ≤40% predicted at screening","White blood cell count \\<3,000/mm³, hemoglobin levels ≤9 g/dL, absolute neutrophil count ≤1,500/mm³, platelets ≤100,000/mm³, or blood transfusion within 60 days before lymphodepletion (LD)"],"whatHappens":"If you join, the listed intervention(s) are NKX019, Fludarabine, or Cyclophosphamide. The registry lists allocation as na. This is a Phase 1/2, open-label, multi-center, multi-cohort, non-randomly assigned dose escalation and dose expansion basket study to determine the whether it is safe and how hard side effects are to live with of NKX019 (allogeneic CAR NK cells targeting CD19) in participants with autoimmune diseases.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 240 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.958Z"},{"nctId":"NCT06737354","title":"Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).","officialTitle":"An Exploratory Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"InnoVec Biotherapeutics Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to evaluate the safety and efficacy of IVB103 injection in subjects with nAMD.","conditions":["nAMD"],"keywords":["nAMD","Retinal Disease"],"interventions":[{"type":"GENETIC","name":"IVB103 Injection（Low dose）"},{"type":"GENETIC","name":"IVB103 Injection（Intermediate dose）"},{"type":"GENETIC","name":"IVB103 Injection（High dose）"}],"enrollment":18,"startDate":"2025-04-22","completionDate":"2027-12-31","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subjects voluntarily participate and sign the informed consent form;\n2. Age≥ 50 years old, gender is not limited;\n3. Confirmed presence of active CNV secondary to nAMD in the macula of study eye;\n4. The total area of all types of lesions in the study eye \\< 30 mm2;\n5. The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63\\~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;\n6. The BCVA detected by the ETDRS eye chart in the non-study eye is not less than 19 letters, which is equivalent to 20/400 of the Snellen Eye Chart;\n7. The study eye has received at least 2 episodes of intravitreal anti- VEGF therapy within 6 months prior to screening and has responded within two weeks of the lead-in period of anti-VEGF standard therapy (Aflibercept injection);\n8. At screening, the blood pregnancy test result of females of childbearing potential (e.g., females who have not undergone surgical sterilization or less than 1 year after menopause) is negative. Male and female subjects of childbearing potential agree to use effective contraception throughout the study and for at least 12 months after dosing.\n\nExclusion Criteria:\n\nStudy Eye：\n\n1. Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;\n2. Presence of retinal hemorrhage, geographic atrophy, scarring or fibrosis, dense subfoveal hard exudate, retinal pigment epithelium (RPE) tear involving the fovea in the study eye;\n3. The study eye is combined with ocular diseases that affect central vision (e.g., diabetic retinopathy, retinal vein occlusion, vascular streaks, pathological myopia, retinal detachment, macular hole, epimacular membrane, toxoplasmosis, optic nerve disease, central serous choroidopathy, Inherited Retinal Diseases(IRDs), etc.);\n4. Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;\n5. Patients with glaucoma and ocular hypertension (intraocular pressure ≥ 25mmHg during the screening period) in the study eye;\n6. Subjects with a history of intravitreal procedures other than anti- VEGF administration within the last six months (e.g., vitrectomy, macular translocation, trabecular meshwork removal, or other filtration surgery;\n7. History of laser or photodynamic therapy for nAMD;\n8. Presence of an ocular implant in the study eye (excluding intraocular lens, custom flex iris prosthesis); Either eye：\n9. History of uveitis in either eye; Systemic diseases and others：\n10. Those with diffuse intravascular coagulation and obvious bleeding tendency (such as hemoptysis, hematemesis, severe purpura, etc.) within 3 months before screening;\n11. History of myocardial infarction, unstable angina, coronary revascularization, cerebrovascular accident (including TIA), history of other thromboembolic diseases (such as thromboembolic angiitis, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, etc.), New York Heart Association (NYHA) grade ≥ II cardiac insufficiency, severe unstable ventricular arrhythmia, within 6 months prior to screening;\n12. Have contraindications to transient immunosuppression of systemic prophylaxis (including but not limited to tuberculosis, osteoporosis, peptic ulcer, severe affective disorder) or immunocompromised;\n13. Patients with systemic immune diseases (including systemic lupus erythematosus, ankylosing spondylitis, rheumatoid arthritis, etc.);\n14. Diabetic patients with any of the following conditions: Known macrovascular complications; Glycosylated hemoglobin at screening（HbA1c）\\>7.5%; Those who have received more than two oral hypoglycemic drugs or received insulin or GLP-1 receptor agonists therapies;\n15. Hypertensive patients with poor blood pressure control (defined as:\n\n    systolic blood pressure ≥ 160 mmHg or diastolic blood pressure\n\n    ≥100 mmHg when the subject is seated after receiving antihypertensive medication);\n16. Any uncontrollable clinical illness (such as severe psychiatric, respiratory and other systemic diseases and history of malignant tumors);\n17. Patients with abnormal liver and kidney function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal; Total bilirubin ≥ 1.5 times the upper limit of normal, creatinine and urea/urea nitrogen ≥ 1.5 times the upper limit of normal;\n18. Patients with abnormal coagulation function: prothrombin time (PT) \\> upper limit of normal value of 3 seconds or activated partial thromboplasting time (APTT) \\> upper limit of normal value of 10 seconds; Haemoglobin (HGb) \\< 10 g/dL;\n19. Those who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, treponema pallidum antibody and human immunodeficiency virus (HIV) antibody;\n20. AAV neutralizing antibody titer \\>1:1000;\n21. Those who are known to be allergic to the therapeutic drugs or diagnostic drugs used in the study protocol, including the investigational products, fluorescein sodium, indocyanine green, etc.;\n22. Those who have used anticoagulant or antiplatelet drugs within 14 days before dosing;\n23. Currently using or may need to use drugs that can cause crystal toxicity or retinal toxicity (such as deferrigin, chloroquine\n\n    /hydroxychloroquine, tamoxifen, ethambutol, etc.);\n24. Those who have a history of surgical operation within 1 month before screening, and/or currently have unhealed wounds (wound degree\\> stage III), moderate to severe ulcers, and fractures;\n25. Patients with systemic infectious diseases requiring systemic treatment (oral, intramuscular or intravenous) at the time of screening;\n26. Those who have received any AAV gene therapy products in the past;\n27. Pregnant or lactating females;\n28. Those who have participated in any clinical trial of drugs (excluding vitamins and minerals) within 3 months before screening;\n29. Other those who need to be excluded in the opinion of the investigator.","locations":[{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cheng Wang","phone":"+8613611238062","email":"clinicaltrial@innovecbio.com"}],"primaryOutcomes":["Incidence of DLTs","Incidence of AEs","Incidence of SAEs"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["chengdu-china"],"enrichment":{"headline":"Phase 1: IVB103 Injection（Low dose） for nAMD","inPlainEnglish":"The goal of this clinical trial is to measure the safety and how well it works of IVB103 injection in subjects with nAMD.","whoItsFor":["Ages 50 Years to any","Age≥ 50 years old, gender is not limited;","Confirmed presence of active CNV secondary to nAMD in the macula of study eye;","The total area of all types of lesions in the study eye \\< 30 mm2;","The Best Corrected Visual Acuity (BCVA) detected by the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart in the study eye is 63\\~19 letters (including boundary values), which is equivalent to 20/63 to 20/400 of the Snellen Eye Chart;","The BCVA detected by the ETDRS eye chart in the non-study eye is not less than 19 letters, which is equivalent to 20/400 of the Snellen Eye Chart;","The study eye has received at least 2 episodes of intravitreal anti- VEGF therapy within 6 months prior to screening and has responded within two weeks of the lead-in period of anti-VEGF standard therapy (Aflibercept injection);"],"whoShouldSkip":["Opacity of refractive media or inability to dilate pupils in the study eye that significantly interferes with visual acuity detection, anterior segment or fundus assessment;","Presence of retinal hemorrhage, geographic atrophy, scarring or fibrosis, dense subfoveal hard exudate, retinal pigment epithelium (RPE) tear involving the fovea in the study eye;","Active intraocular or periocular infection (such as blepharitis, conjunctivitis, keratitis, scleritis, etc.) in the study eye;","Patients with glaucoma and ocular hypertension (intraocular pressure ≥ 25mmHg during the screening period) in the study eye;","Subjects with a history of intravitreal procedures other than anti- VEGF administration within the last six months (e.g., vitrectomy, macular translocation, trabecular meshwork removal, or other filtration surgery;","History of laser or photodynamic therapy for nAMD;","Presence of an ocular implant in the study eye (excluding intraocular lens, custom flex iris prosthesis); Either eye："],"whatHappens":"If you join, the listed intervention(s) are IVB103 Injection（Low dose）, IVB103 Injection（Intermediate dose）, or IVB103 Injection（High dose）. The registry lists allocation as randomized. The goal of this clinical trial is to measure the safety and how well it works of IVB103 injection in subjects with nAMD.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 18 people at Chengdu. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.141Z"},{"nctId":"NCT06741085","title":"A Study of Stereotactic Radiosurgery (SRS) and Standard Treatment in People With Lung Cancer That Has Spread to the Brain","officialTitle":"ICON-RT: Intracranial Consolidation and Deferral of Radiation Therapy in Patients Receiving Approved CNS-Active Systemic Therapeutics","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.","conditions":["Non Small Cell Lung Cancer Metastatic"],"keywords":["somatic activating mutation in EGFR","consolidative stereotactic radiosurgery","tyrosine-kinase inhibitor"],"interventions":[{"type":"DRUG","name":"osimertinib"},{"type":"RADIATION","name":"stereotactic radiosurgery (SRS)"}],"enrollment":56,"startDate":"2024-12-13","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Participant Inclusion Criteria: Screening\n\n* Age ≥ 18 years\n* Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution\n* At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)\n* Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)\n\nParticipant Exclusion Criteria: Screening\n\n* Unable to undergo contrast-enhanced MRI brain\n* Prior brain-directed radiotherapy\n* Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated.\n* Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS\n* Active hematologic malignancy or a second solid tumor histology with known CNS tropism\n* Patients who have undergone a therapeutic craniotomy for resection of one or more symptomatic brain metastasis are ineligible unless one or more additional intact BM remain unresected, and meets size criteria (e.g., a patient with removal of a 3cm symptomatic brain metastasis, but has an additional visible lesion remaining post-operatively, remains eligible for the study).\n* Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.\n* Pregnant women or women who are breastfeeding or of childbearing potential. If the risk of contraception exists, male and female subjects must use highly effective contraception throughout the study and for at least 3 months after last treatment. Highly effective contraception includes either 2 barrier methods (diaphragm, condom by the partner, copper intrauterine device, sponge, or spermicide), or 1 barrier method and 1 hormonal method (any oral, subcutaneous, intrauterine, or intramuscular registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent)\n\nParticipant Inclusion Criteria: Randomization\n\n\\- Presence of detectable and non-progressing BM lesions on imaging consistent with viable residual disease\n\nParticipant Exclusion Criteria: Randomization\n\n* Progressive Disease (PD) with multiple lesions and/or other features that would warrant a change in systemic therapy, as determined by the primary treating provider\n* Presence of BM not deemed safely treatable with SRS, as determined by a radiation oncologist\n* Intracranial Complete Response (CR)\n* More than 20 visible residual brain metastases at the time of enrollment (i.e. after initial treatment with TKI). However, no upper limit on the number of visible brain metastases is set at the time of initial diagnosis prior to treatment with TKI. For example, a patient who had 35 visible brain metastases at the time of diagnosis, but after three months of treatment with TKI had 10 visible brain metastases remaining will be eligible for enrollment and randomization","locations":[{"facility":"BAPTIST ALLIANCE - MCI (Data Collection Only)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Basking Ridge (All Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (All Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (All Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (All Protocol Activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (All Protocol Activities)","city":"Rockville Centre","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luke Pike, MD","phone":"212-639-8157","email":"pikel@mskcc.org"},{"name":"Helena Yu, MD","phone":"646-608-3912","email":""}],"primaryOutcomes":["intracranial progression-free survival (iPFS)"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["osimertinib"],"locationSlugs":["miami-florida","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","rockville-centre-new-york"],"enrichment":{"headline":"Phase 2: testing osimertinib for Non Small Cell Lung Cancer Metastatic","inPlainEnglish":"The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC. The researchers will also look at how the study intervention impacts participants' quality of life.","whoItsFor":["Ages 18 Years to any","Participant Screening","Non-small cell lung cancer (NSCLC) with somatic activating mutation in EGFR diagnosis, confirmed at enrolling institution","At least one intact brain metastasis at baseline prior to TKI therapy initiation, visible on MRI brain with contrast (but without a minimum diameter requirement)","Either TKI-naïve or started TKI ≤ 3-months prior (with documented start date and available imaging prior to TKI start)"],"whoShouldSkip":["Unable to undergo contrast-enhanced MRI brain","Prior brain-directed radiotherapy","Evidence of leptomeningeal disease on MRI total spine and/or lumbar puncture cytology. The latter are not mandated by protocol but are rather at the discretion of the treating medical team as clinically indicated","Neurologic symptoms or presence of a lesion in the brainstem, motor strip, or other eloquent brain area that is felt to warrant immediate intervention with SRS","Active hematologic malignancy or a second solid tumor histology with known CNS tropism","Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements","Participant who can join: Randomization"],"whatHappens":"If you join, the listed intervention(s) are osimertinib, or stereotactic radiosurgery (SRS). The registry lists allocation as randomized. The researchers are doing this study is to find out whether treating brain metastasis with SRS after 3 months of therapy with osimertinib is better than treating with osimertinib alone in people with NSCLC.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 56 people at 8 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.678Z"},{"nctId":"NCT06741553","title":"Prospective Cohort Study of Patients With Early Alzheimer's Disease Treated With Lecanemab","officialTitle":"A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","sponsorClass":"OTHER","summary":"As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications. Lecanemab, an FDA-approved clinical treatment drug in 2023, targets the core pathology of AD-abnormal amyloid-beta (Aβ) aggregation in the brain-and has been validated through both biomarker and clinical scale assessments. The optimal dosage and safety-efficacy profile of lecanemab for treating early AD have been observed in phase 2 and phase 3 clinical trials. However, the use of lecanemab may lead to certain adverse effects, including infusion-related reactions, amyloid-related imaging abnormalities (ARIA), such as microhemorrhages or hemosiderin deposits (ARIA-H), and ARIA-E. This study aims to establish a prospective follow-up cohort of patients treated with lecanemab to observe changes in cranial imaging characteristics and clinical symptoms, assess the cognitive improvement effects of lecanemab in early AD patients (stages 3-4), and monitor the risk factors for adverse event occurrence.","conditions":["Alzheimer Disease","Mild Cognitive Impairment (MCI)"],"keywords":["Alzheimer Disease","Lecanemab","Cognition","Amyloid-related imaging abnormalities"],"interventions":[{"type":"DRUG","name":"Lecanemab 10 mg/kg"}],"enrollment":120,"startDate":"2024-06-28","completionDate":"2026-06","sex":"ALL","minAge":null,"maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;\n* Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;\n* Completion of APOE gene testing.\n* Willingness to use Lecanemab.\n\nExclusion Criteria:\n\n* Unable to tolerate MRI scans;\n* MRI showing hemorrhagic manifestations, including \\>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;\n* Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;\n* With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.","locations":[{"facility":"Affiliated Hospital, School of Medicine, Zhejiang University, China","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yanxing Chen, M.D.","phone":"+86 188 6840 1257","email":"chenyanxing@zju.edu.cn"}],"primaryOutcomes":["CDR-SB Score","MMSE","ADCs-ADL","NPI"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":["lecanemab"],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Lecanemab 10 mg/kg for Alzheimer Disease","inPlainEnglish":"As the population increases and aging intensifies, cognitive disorders represented by Alzheimer's disease (AD) not only pose a severe threat to public health but also bring significant social and economic burdens. Previously, treatment options for Alzheimer's disease were very limited, mainly providing symptomatic relief with few available medications.","whoItsFor":["Ages any to 85 Years","Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1;","Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing;","Completion of APOE gene testing","Willingness to use Lecanemab"],"whoShouldSkip":["Unable to tolerate MRI scans;","MRI showing hemorrhagic manifestations, including \\>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations;","Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding;","With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Hangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.234Z"},{"nctId":"NCT06742307","title":"Faricimab Quarterly Maintenance for Neovascular Age Related Macular Degeneration","officialTitle":"Faricimab Fixed Quarterly Maintenance for Neovascular Age Related Macular Degeneration: A Prospective Case Series","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hospital Authority, Hong Kong","sponsorClass":"OTHER_GOV","summary":"We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.","conditions":["Macular Degeneration Choroidal Neovascularization"],"keywords":["neovascular age related macular degeneration","faricimab"],"interventions":[{"type":"DRUG","name":"Faricimab Injection [Vabysmo]"}],"enrollment":40,"startDate":"2025-08-21","completionDate":"2026-10-01","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nSubjects aged over 50 years, neovascular AMD with foveal involvement, both treatment-naïve and recurrent cases. There were no specific criteria for initial best-corrected visual acuity (BCVA). Only active subfoveal MNV are included, including types 1, 2, and 3.\n\nExclusion Criteria:\n\n* eyes that received any anti-VEGF therapy in the prior six months,\n* eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),\n* concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period.","locations":[{"facility":"Department of Ophthalmology, United Chrisitian Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel Ho Tak Wong, FRCOphth (UK)","phone":"+852 3949 3411","email":"WHT454@ha.org.hk"}],"primaryOutcomes":["Visual acuity"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Phase 4: testing Faricimab Injection [Vabysmo] for Macular Degeneration Choroidal Neovascularization","inPlainEnglish":"We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.","whoItsFor":["Ages 50 Years to any","Subjects aged over 50 years, neovascular AMD with foveal involvement, both treatment-naïve and recurrent cases. There were no specific criteria for initial best-corrected visual acuity (BCVA). Only active subfoveal MNV are included, including types 1, 2, and 3"],"whoShouldSkip":["eyes that received any anti-VEGF therapy in the prior six months,","eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),","concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period"],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 40 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.134Z"},{"nctId":"NCT06742723","title":"A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure","officialTitle":"A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure","conditions":["Chronic Kidney Disease and Hypertension"],"keywords":["Chronic kidney disease","Hypertension","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome"],"interventions":[{"type":"DRUG","name":"Baxdrostat/dapagliflozin"},{"type":"DRUG","name":"Placebo/dapagliflozin"}],"enrollment":5000,"startDate":"2025-03-03","completionDate":"2029-12-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with (a) or (b):\n\n   a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 30 mg/g (3.39 mg/mmol) and \\< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or\n   * UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).\n\n     (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)\n3. \\[obsolete\\]\n4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.\n5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values)\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \\< 45 mL/min/1.73 m2 (local or central laboratory values)\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.\n3. Serum sodium \\< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).\n\n4\\. Participants with T1DM will be excluded, except:\n\n1. For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion.\n2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion.\n\n   5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).\n\n   6 New York Heart Association functional HF class IV at screening.\n\n   7 Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation.\n\n   8 Documented history of adrenal insufficiency.\n\n   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.\n\n   10 Any acute kidney injury within 3 months prior to the Screening Visit.\n\n   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n\n   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).","locations":[{"facility":"Research Site","city":"Fairhope","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Canoga Park","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research 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3: testing Baxdrostat/dapagliflozin for Chronic Kidney Disease and Hypertension","inPlainEnglish":"International, Multicenter, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment and Event-driven study to assess how well it works, whether it is safe and how hard side effects are to live with of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure","whoItsFor":["Ages 18 Years to any","Participants with (a) or (b):","a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:","UACR ≥ 30 mg/g (3.39 mg/mmol) and \\< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or","UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or","UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)","(b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:","UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or"],"whoShouldSkip":["Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening","Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening","Serum sodium \\< 135 mmol/L (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit)","4\\. Participants with T1DM will be excluded, except:","For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion","For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion","5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit)"],"whatHappens":"If you join, the listed intervention(s) are Baxdrostat/dapagliflozin, or Placebo/dapagliflozin. The registry lists allocation as randomized. International, Multicenter, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment and Event-driven study to assess how well it works, whether it is safe and how hard side effects are to live with of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 5,000 people at 604 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.496Z"},{"nctId":"NCT06743126","title":"SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma","officialTitle":"A Prospective, Multicenter, Open-label, Randomized, Actively Controlled, Parallel-group Phase 3 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of IMA203 Versus Investigator's Choice of Treatment in Patients With Previously Treated, Unresectable or Metastatic Cutaneous Melanoma (ACTengine® IMA203-301)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Immatics US, Inc.","sponsorClass":"INDUSTRY","summary":"This clinical trial is a prospective, multicenter, open-label, randomized, actively controlled, parallel-group Phase 3 clinical trial to evaluate the efficacy, safety and tolerability of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma or mucosal melanoma (MM).\n\nFor patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/","conditions":["Melanoma, Cutaneous Malignant","Mucosal Melanoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"IMA203"},{"type":"BIOLOGICAL","name":"nivolumab plus relatlimab"},{"type":"BIOLOGICAL","name":"lifileucel"},{"type":"BIOLOGICAL","name":"nivolumab"},{"type":"BIOLOGICAL","name":"pembrolizumab"},{"type":"BIOLOGICAL","name":"ipilimumab"},{"type":"DRUG","name":"Dacarbazine"},{"type":"DRUG","name":"temozolomide"},{"type":"DRUG","name":"paclitaxel"},{"type":"DRUG","name":"paclitaxel plus carboplatin"},{"type":"DRUG","name":"Albumin-Bound Paclitaxel"}],"enrollment":450,"startDate":"2025-01-14","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically confirmed and documented cutaneous melanoma or mucosal melanoma. CM patients (including acral melanoma and melanoma of unknown primary) and mucosal melanoma patients with unresectable or metastatic disease\n* Positive for HLA-A\\*02:01 or one of its P-group alleles\n* Adequate selected organ function per protocol\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as monotherapy or in combination with other therapies as treatment for unresectable or metastatic melanoma\n* Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy (with or without a MEK inhibitor) prior to initial eligibility assessment, unless deemed not clinically indicated at Investigator's discretion due to concurrent medical condition, prior toxicity, or if declined by the patient\n* Life expectancy more than 6 months\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)\n* Female patient of childbearing potential must use adequate contraception from randomization until 12 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)\n* Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203 or in line with the instructions provided for investigator's choice treatment (in the control arm)\n* The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to randomization and prior to trial treatment start.\n\nExclusion Criteria:\n\n* Uveal melanoma\n* History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years\n* Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents.\n* History of cardiac conditions as per protocol\n* Prior allogenic stem cell transplantation or solid organ transplantation\n* Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician\n* History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs\n* Known hypersensitivity to any of the rescue medications\n* History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the investigator\n* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.\n* Any condition contraindicating leukapheresis\n* Pregnant or breastfeeding\n* Any other condition that would, in the investigator's or sponsor's judgment, contraindicate the patient's participation in the clinical trial because of safety concerns or compliance with clinical trial procedures (e.g., psychiatric disorders or substance dependence, neurological impairment)\n* Patient has received systemic corticosteroids within 2 weeks prior to leukapheresis,\n* Patient has received surgery or other anti-cancer therapies, any agent that is likely to suppress bone marrow function, or investigational medicinal products within 7 days prior to leukapheresis.\n* Patients with any active infection or ongoing reactivation of infection\n* Patients who underwent non-myeloablative lymphodepletion prior to cell therapy within the last 6 months\n* Prior treatment with IMA203\n* Patients with ascites, pleural or pericardial effusion which requires repeated (2 within 4 weeks) or continuous paracentesis, thoracentesis or pericardiocentesis within last 2 months\n* Patients with LDH greater than 2.0-fold ULN\n* Concurrent treatment in another clinical trial or a device study that could interfere with the IMA203 treatment or planned investigator's choice treatment\n* Patients with active brain metastases or leptomeningeal metastases\n* Patient has received any investigational therapies, inactivated vaccines, chronic use of systemic corticosteroids or IV antibiotics within 1 week prior to randomization, or live vaccines within 4 weeks prior to randomization\n* Patient has received any anti-cancer therapy (prior anti-cancer treatment or bridging therapy) or radiotherapy within 1 week prior to start of trial treatment\n* Other protocol defined inclusion/exclusion criteria could apply","locations":[{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Honor Health Research Institute","city":"Scottsdale","state":"Arizona","country":"United 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Clinic, Taussig Cancer Institute","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Cancer Institute Franz Clinic","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lehigh Valley Topper Cancer Institute","city":"Allentown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania, Abramson Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jeffersion University, Sidney Kimmel Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fox Chase 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Network, Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire De Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assistance Publique Hopitaux De Paris, Hôpital Saint Louis","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitatsklinikum Koeln","city":"Cologne","state":"Northrhine-W Estphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite Universitaetsmedizin Berlin KöR","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Bonn AöR","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Technische Universitaet Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Erlangen AöR","city":"Erlangen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Essen AöR","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Goethe University Frankfurt","city":"Frankfurt am Main","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Hamburg-Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Heidelberg AöR","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaet Leipzig","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","city":"Mainz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Groningen","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","city":"Rotterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Greater Glasgow and Clyde NHS, Beatson West of Scotland Cancer Center","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's and St Thomas' NHS Foundation Trust, Guy's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals NHS Foundation Trust, Churchill Hospital","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southampton NHS Foundation Trust, Southampton General Hospital","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Immatics US, Inc.","phone":"+1 346 204-5400","email":"ctgovinquiries@immatics.com"}],"primaryOutcomes":["Progression-free survival assessed by BICR"],"hasResults":false,"conditionSlugs":["melanoma","als"],"drugSlugs":["pembrolizumab","nivolumab"],"locationSlugs":["phoenix-arizona","scottsdale-arizona","duarte-california","la-jolla-california","los-angeles-california","san-francisco-california","stanford-california","aurora-colorado","new-haven-connecticut","jacksonville-florida","miami-florida","orlando-florida","tampa-florida","atlanta-georgia","chicago-illinois","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","rochester-minnesota","omaha-nebraska","morristown-new-jersey","new-york-new-york","rochester-new-york","chapel-hill-north-carolina","cleveland-ohio","columbus-ohio","portland-oregon","allentown-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","sioux-falls-south-dakota","nashville-tennessee","dallas-texas","houston-texas","salt-lake-city-utah","richmond-virginia","seattle-washington","madison-wisconsin","edmonton-canada","vancouver-canada","toronto-canada","montreal-canada","lille-france","paris-france","villejuif-france","cologne-germany","berlin-germany","bonn-germany","dresden-germany","erlangen-germany","essen-germany","frankfurt-am-main-germany","hamburg-germany","heidelberg-germany","leipzig-germany","mainz-germany","amsterdam-netherlands","groningen-netherlands","rotterdam-netherlands","cambridge-united-kingdom","glasgow-united-kingdom","london-united-kingdom","manchester-united-kingdom","oxford-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing IMA203 for Melanoma, Cutaneous Malignant","inPlainEnglish":"This clinical trial is a prospective, multicenter, open-label, randomly assigned, actively controlled, parallel-group Phase 3 clinical trial to measure the how well it works, whether it is safe and how hard side effects are to live with of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma or mucosal melanoma (MM). For patients interested in additional information on how to participate, please follow this link: https://mytomorrows.com/trials/suprame/en-us/","whoItsFor":["Ages 18 Years to any","Pathologically confirmed and documented cutaneous melanoma or mucosal melanoma. CM patients (including acral melanoma and melanoma of unknown primary) and mucosal melanoma patients with unresectable or metastatic disease","Positive for HLA-A\\*02:01 or one of its P-group alleles","Adequate selected organ function per protocol","Eastern Cooperative Oncology Group (ECOG) performance status 0-1","Disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor, applied either as this drug alone or in combination with other therapies as treatment for unresectable or metastatic melanoma","Life expectancy more than 6 months","Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)"],"whoShouldSkip":["History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years","Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents","History of cardiac conditions as per protocol","Prior allogenic stem cell transplantation or solid organ transplantation","Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study","History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician","History of hypersensitivity to CY, FLU, or IL-2 or presence of any contraindications and other limitations for planned treatment with investigator's choice as laid down in the current versions of the respective PIs / SmPCs"],"whatHappens":"If you join, the listed intervention(s) are IMA203, nivolumab plus relatlimab, or lifileucel. The registry lists allocation as randomized. This clinical trial is a prospective, multicenter, open-label, randomly assigned, actively controlled, parallel-group Phase 3 clinical trial to measure the how well it works, whether it is safe and how hard side effects are to live with of treatment with IMA203 administered at the recommended phase 2 dose versus investigator's choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma or mucosal melanoma (MM).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 450 people at 71 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.016Z"},{"nctId":"NCT06743581","title":"Study of Neoadjuvant Cemiplimab and Dupilumab in Early-Stage Non-Small Cell Lung Cancer","officialTitle":"Phase I/II Study of Combined Treatment With Cemiplimab (Anti-PD-1) and Dupilumab (Anti-IL-4R) in Patients With Early-stage, Resectable NSCLC","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Centre hospitalier de l'Université de Montréal (CHUM)","sponsorClass":"OTHER","summary":"This phase 1b/2a study evaluates the safety, feasibility, and efficacy of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design. Secondary endpoints include event-free survival, overall survival, and translational objectives such as deep immune monitoring from patient samples, with the trial expected to enroll 24 patients at CHUM over five years.","conditions":["Non-Small Cell Lung Cancer","Immunotherapy","Neoadjuvant Therapy"],"keywords":["NSCLC","Neoadjuvant immunotherapy","Cemiplimab","Dupilumab"],"interventions":[{"type":"DRUG","name":"Cemiplimab"},{"type":"DRUG","name":"Dupilumab"}],"enrollment":24,"startDate":"2025-08-19","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures.\n* Age ≥ 18 years.\n* ECOG performance status 0-1\n* Determined to be a surgical candidate for tumor resection by a multidisciplinary team.\n* Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately.\n* Adequate organ and marrow function.\n* Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\\>1cm) and amenable to biopsy as determined by a multidisciplinary team.\n* Patients must consent to provide blood at designated study time points.\n* Patients must consent to core needle biopsies (at least 3 samples, as deemed safe by the performing surgeon/radiologist) prior to treatment initiation\n\nExclusion Criteria:\n\n* History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation.\n* Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin.\n* Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent.\n* No smoking history or confirmed tissue or ctDNA evidence of actionable driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements)\n* Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable.\n* Metastatic disease where surgery would not have curative intent.\n* Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric/social conditions impeding study compliance.\n* Pregnancy or nursing, due to potential harm to the fetus or infant.\n* Progressive malignancy requiring active treatment, except for certain stable cancers treated with curative intent\n* HIV infection with detectable viral load or not on a stable HAART regimen\n* Active Hepatitis B or C (PCR-detectable)\n* History of allogeneic hematopoietic or solid organ transplantation.\n* Documented hypersensitivity to protein therapeutics.\n* Any condition, therapy, or abnormality that may interfere with trial results, patient participation, or their best interest as per the investigator's judgment.","locations":[{"facility":"CHUM","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Antoine Desilets, MD, MSc","phone":"514-890-8444","email":"antoine.desilets.med@ssss.gouv.qc.ca"},{"name":"Wiam Belkaid, PhD","phone":"514-836-3273","email":"wiam.belkaid.chum@ssss.gouv.qc.ca"}],"primaryOutcomes":["Safety","Efficacy"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["dupilumab"],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: testing Cemiplimab for Non-Small Cell Lung Cancer","inPlainEnglish":"This phase 1b/2a study evaluates the safety, feasibility, and how well it works of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC. Phase 1b focuses on safety and feasibility, using a 3+3 design to monitor dose-limiting toxicities (DLTs), while Phase 2a assesses the major pathological response (MPR) rate with a Simon's two-stage minimax design.","whoItsFor":["Ages 18 Years to any","Histological confirmation of NSCLC is required before treatment (however, patients with a smoking history and radiographic findings suggestive of NSCLC may consent prior to biopsy to combine research and diagnostic procedures","how well you can do daily activities (ECOG score) 0-1","Determined to be a surgical candidate for tumor resection by a multidisciplinary team","Women of childbearing potential and men must use approved contraception during the study and for 4 months post-treatment. Pregnancy or suspected pregnancy must be reported immediately","Adequate organ and marrow function","Pre-treatment biopsies are mandatory, and tumors must be T1b or larger (\\>1cm) and amenable to biopsy as determined by a multidisciplinary team","Patients must consent to provide blood at designated study time points"],"whoShouldSkip":["History of autoimmune disorders or use of immunomodulatory drugs (including dupilumab) within 2 months prior to treatment initiation","Active autoimmune disease requiring systemic treatment in the past year, excluding replacement therapies like thyroxine or insulin","Use of immunosuppressive drugs or systemic steroids within 7 days prior to treatment, except chronic steroids ≤10mg prednisone or equivalent","No smoking history or confirmed tissue or ctDNA evidence of actionable driver alterations (e.g. EGFR mutation, ALK, or ROS1 rearrangements)","Prior chemotherapy or radiotherapy for another primary tumor, or prior locoregional therapy to the target lesion. Therapy for a different cancer is acceptable","Metastatic disease where surgery would not have curative intent","Uncontrolled illness, including active infections requiring antibiotics, symptomatic heart failure, unstable angina, or psychiatric/social conditions impeding study compliance"],"whatHappens":"If you join, the listed intervention(s) are Cemiplimab, or Dupilumab. The registry lists allocation as na. This phase 1b/2a study evaluates the safety, feasibility, and how well it works of combining dupilumab (anti-IL-4Rα) and cemiplimab (anti-PD-1) in patients with early-stage, resectable NSCLC.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.711Z"},{"nctId":"NCT06745063","title":"Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity","officialTitle":"Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.","conditions":["Obesity","Vascular Health"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin"},{"type":"DRUG","name":"Placebo"}],"enrollment":50,"startDate":"2025-05-30","completionDate":"2028-12-31","sex":"ALL","minAge":"30 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Body mass index (BMI) 30-45 kilograms per square meter (kg/m2)\n* 30-60 years of age at randomization\n* Evidence of arterial stiffening (defined as Carotid femoral PWV\\>age-predicted) at screening visit (PMID: 20530030), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Diabetes mellitus\n* Uncontrolled hypertension (\\>180/90 millimeters of mercury) or systolic \\<100 millimeters of mercury at screening visit\n* Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke\n* Diagnosis of chronic kidney disease\n* Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)\n* Excessive alcohol consumption (\\>14 drinks/week for men, \\>7 drinks/week for women)\n* Use of GLP-1 analogs or SGLT2 inhibitors\n* Use of hormone replacement therapy\n* Use of pharmacological therapy for weight loss\n* Body weight changes \\>10% within the past 6 months\n* History of hypersensitivity to nitrates\n* History of ketoacidosis\n* History of recurrent UTIs or mycotic genital infections\n* Use of anticoagulants\n* Change in anti-hypertensive medication regimen (if in use) during the last 90 days\n* Pregnancy","locations":[{"facility":"Harry S. Truman Memorial, Columbia, MO","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jaume Padilla Parellada, PhD","phone":"(573) 814-6552","email":"jaume.padillaparellada@va.gov"},{"name":"Camila Margarita M Manrique Acevedo, MD","phone":"(573) 814-6550","email":"camila.manrique-acevedo@va.gov"}],"primaryOutcomes":["Carotid-femoral Pulse Wave Velocity (cfPWV)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["empagliflozin"],"locationSlugs":["columbia-missouri"],"enrichment":{"headline":"Phase 2: testing Empagliflozin for Obesity","inPlainEnglish":"The study will assign participants to take either the medication, empagliflozin or a dummy treatment (placebo) for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.","whoItsFor":["Ages 30 Years to 60 Years","Body mass index (body-mass index (BMI)) 30-45 kilograms per square meter (kg/m2)","30-60 years of age at randomization","Evidence of arterial stiffening (defined as Carotid femoral PWV\\>age-predicted) at screening visit (PMID: 20530030), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents"],"whoShouldSkip":["Uncontrolled hypertension (\\>180/90 millimeters of mercury) or systolic \\<100 millimeters of mercury at screening visit","Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke","Diagnosis of chronic kidney disease","Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)","Excessive alcohol consumption (\\>14 drinks/week for men, \\>7 drinks/week for women)","Use of GLP-1 analogs or SGLT2 inhibitors","Use of hormone replacement therapy"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin, or Placebo. The registry lists allocation as randomized. The study will assign participants to take either the medication, empagliflozin or a dummy treatment (placebo) for 12 weeks.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Columbia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.615Z"},{"nctId":"NCT06749054","title":"Evaluation of Long-Acting Lenacapavir for the Treatment of HIV-1 in Treatment-experienced Adolescents and Children","officialTitle":"A Phase 2, Open-label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Long-Acting Lenacapavir in Combination With an Optimized Background Regimen in Treatment-experienced Adolescents and Children With HIV-1","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and efficacy of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1. The study will also see how easy it is for participants to take LEN as injection or an oral pill.\n\nThe primary objectives are to evaluate the pharmacokinetics and safety of LEN in combination with optimized background regimen (OBR) in TE pediatric participants with HIV-1.","conditions":["HIV-1-infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"Oral Lenacapavir"},{"type":"DRUG","name":"Subcutaneous Lenacapavir"},{"type":"DRUG","name":"Optimized Background Regimen (OBR)"}],"enrollment":12,"startDate":"2025-03-26","completionDate":"2027-03","sex":"ALL","minAge":null,"maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Body weight at screening ≥ 35 kg.\n* On a stable failing antiretroviral (ARV) regimen for \\> 8 weeks before screening and willing to continue the regimen until Day 1.\n* Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening.\n* Have previously changed their ARV regimen due to treatment failure.\n* ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access.\n* Able and willing to commit to taking LEN in combination with their OBR.\n* The following laboratory parameters at screening:\n\n  1. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m\\^2 using Bedside Schwartz Formula.\n  2. Absolute neutrophil count \\> 0.50 GI/L (\\> 500 cells/mm\\^3).\n  3. Hemoglobin ≥ 85 g/L (\\> 8.5 g/dL).\n  4. Platelets ≥ 50 GI/L (≥ 50,000/mm\\^3).\n  5. Hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal.\n  6. Total bilirubin ≤ 23 μmol/L (≤ 1.5 mg/dL) and direct bilirubin ≤ 7 μmol/L (≤ 0.4 mg/dL).\n\nKey Exclusion Criteria:\n\n* Life expectancy ≤ 1 year.\n* An opportunistic illness requiring treatment within the 30 days prior to screening.\n* Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening.\n* Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening.\n* Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Grady Health System, Ponce De Leon Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FAMCRU","city":"Cape Town","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRISMO Research Centre","city":"Germiston","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wits RHI Shandukani Research Centre CRS","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rahima Moosa Mother and Child Hospital","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute of South Africa (CRISA)","city":"KwaDukuza","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Durban International Clinical Research Site, Enhancing Care Foundation","city":"KwaZulu - Natal","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Part Research Pty (Ltd)","city":"Paarl","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perinatal HIV Research Unit (PHRU)","city":"Soweto","state":"","country":"South Africa","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Pharmacokinetic (PK) Parameter: Ctrough, W26 of Lenacapavir (LEN)","Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) Through Week 26","Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Through Week 26"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["atlanta-georgia","cape-town-south-africa","germiston-south-africa","johannesburg-south-africa","kwadukuza-south-africa","kwazulu-natal-south-africa","paarl-south-africa","soweto-south-africa"],"enrichment":{"headline":"Phase 2: testing Oral Lenacapavir for HIV-1-infection","inPlainEnglish":"The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN). The study will assess the safety, tolerability, and how well it works of long-acting LEN when combined with other medicines in adolescents and children living with HIV-1 who weigh at least 35 kg and have been treated before for HIV-1.","whoItsFor":["Ages any to 17 Years","Body weight at screening ≥ 35 kg","On a stable failing antiretroviral (ARV) regimen for \\> 8 weeks before screening and willing to continue the regimen until Day 1","Plasma HIV-1 RNA ≥ 400 copies/mL on at least 2 consecutive occasions spanning at least 6 months, including at screening","Have previously changed their ARV regimen due to treatment failure","ARV treatment options limited due to resistance, tolerability, contraindications, safety, drug access","Able and willing to commit to taking LEN in combination with their OBR","The following laboratory parameters at screening:"],"whoShouldSkip":["Life expectancy ≤ 1 year","An opportunistic illness requiring treatment within the 30 days prior to screening","Evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening","Hepatitis C virus (HCV) antibody positive with detectable HCV RNA at screening","Hepatitis B virus (HBV) surface antigen (HBsAg) positive or HBV core antibody (antibody against hepatitis B core antigen (anti-HBc)) positive; if individual is HBsAg negative and anti-HBc positive but HBV DNA undetectable, individual may be enrolled","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Oral Lenacapavir, Subcutaneous Lenacapavir, or Optimized Background Regimen (OBR). The registry lists allocation as na. The goal of this clinical study is to learn more about the study drug, lenacapavir (LEN).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 12 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.400Z"},{"nctId":"NCT06751238","title":"Study to Evaluate the Pharmacokinetics (PK), Safety and Tolerability up to 6 Years of Intravenous (i.v.) Secukinumab in Pediatric Participants With Juvenile Psoriatic Arthritis (JPsA).","officialTitle":"An Open-label, Multicenter Study to Evaluate Pharmacokinetics, Safety and Tolerability up to 6 Years of Intravenous Secukinumab Infusions in Pediatric Participants With Juvenile Psoriatic Arthritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to determine the PK, safety and tolerability of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA","conditions":["Juvenile Psoriatic Arthritis"],"keywords":["Pediatric","JPsA","Pharmacokinetic (PK)","safety","Intravenous (i.v.)","Secukinumab"],"interventions":[{"type":"BIOLOGICAL","name":"Secukinumab"}],"enrollment":20,"startDate":"2025-09-24","completionDate":"2029-10-31","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Participants parent's or legal representative(s) written informed consent and child's assent, if appropriate, must be obtained before any study related activity or assessment is performed. Of note, if the participant reaches age of consent (as per local law) during the study, they will also need to sign the corresponding study ICF (Informed Consent Form).\n* Males and females ≥2 years old to \\<18 years old at the time of screening.\n* Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening.\n* Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL).\n* Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening.\n* Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening.\n* Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:\n\n  * Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center).\n  * Stable dose of an oral corticosteroid (CS) at a prednisone equivalent dose of \\<0.2 mg/kg/day or up to 10 mg/day maximum, whichever is less, for at least 7 days prior to BSL.\n  * Stable dose of no more than one NSAID for at least 1 week prior to BSL.\n\nKey Exclusion Criteria:\n\n* Participants with body weight less than 10 kg at screening.\n* Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer.\n* History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes.\n* Participants with active inflammatory bowel disease or active uveitis at screening or BSL.\n* Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL.\n* Participants treated with prohibited medication\n* Participants taking any non-biologic DMARD at screening except for MTX.\n* Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the study per protocol.\n\nOther inclusion/exclusion criteria may apply","locations":[{"facility":"Loma Linda University Health","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann and Robert H Lurie Childs Hosp","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Col Uni Med Center New York Presby","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Levine Childrens Hospital","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Childrens Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univ Hosp Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Legacy Emanuel Research Hosp Portland","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hosp Pittsburgh UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Arthritis Center","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Maximum concentration on Day 1","Maximum concentration at steady-state (Cmax, ss)","Minimum concentration at steady-state (Cmin, ss)","Area under the concentration-time curve at steady-state (AUCtau, ss)","Average concentration at steady-state (Cavg,ss)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["loma-linda-california","gainesville-florida","chicago-illinois","new-york-new-york","charlotte-north-carolina","cincinnati-ohio","cleveland-ohio","portland-oregon","pittsburgh-pennsylvania","el-paso-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 1: testing Secukinumab for Juvenile Psoriatic Arthritis","inPlainEnglish":"This study wants to determine the PK, whether it is safe and how hard side effects are to live with of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA","whoItsFor":["Ages 2 Years to 17 Years","Males and females ≥2 years old to \\<18 years old at the time of screening","Confirmed diagnosis of JPsA according to the modified International League of Associations for Rheumatology (ILAR) classification criteria that must have occurred at least 6 months prior to screening","Active JPsA disease defined as ≥3 active joints (swollen or if not swollen must be both tender and limited range of motion) at baseline (BSL)","Inadequate response (≥1 month) or intolerance to ≥1 Non-Steroidal Anti-Inflammatory Drug (NSAID) at screening","Inadequate response (≥2 months) or intolerance to ≥ 1 Disease Modifying Anti-Rheumatic Drug (DMARD) at screening","Concomitant use of the following second-line agents such as disease-modifying and/or immunosuppressive drugs to treat the JPsA will be allowed:","Stable dose of methotrexate (MTX) (maximum of 20 mg/ m2 BSA/ week) for at least 4 weeks prior to the BSL visit, with folic/folinic acid supplementation (according to standard medical practice of the center)"],"whoShouldSkip":["Participants with body weight less than 10 kg at screening","Use of other investigational drugs within 4 weeks or 5 half-lives of BSL, or until the expected pharmacodynamic effect has returned to BSL, whichever is longer","History of hypersensitivity to study drug or its excipients or to drugs of similar chemical classes","Participants with active inflammatory bowel disease or active uveitis at screening or BSL","Fulfilling diagnostic criteria for any International League of Associations for Rheumatology (ILAR ) juvenile idiopathic arthritis (JIA) category other than JPsA at BSL","Participants treated with prohibited medication","Participants taking any non-biologic DMARD at screening except for MTX"],"whatHappens":"If you join, the listed intervention(s) are Secukinumab. The registry lists allocation as na. This study wants to determine the PK, whether it is safe and how hard side effects are to live with of multiple doses of intravenous (i.v.) secukinumab in pediatric participants with JPsA","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at 11 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.073Z"},{"nctId":"NCT06757634","title":"Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)","officialTitle":"VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Celcuity Inc","sponsorClass":"INDUSTRY","summary":"This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.","conditions":["Breast Cancer"],"keywords":["Breast Cancer, Advanced or Metastatic","Gedatolisib","HR Positive","ER Positive","HER2 Negative","PIK3CA MT","PI3K"],"interventions":[{"type":"DRUG","name":"Arm A: Gedatolisib + Palbociclib + Fulvestrant"},{"type":"DRUG","name":"Arm B: Ribociclib + Fulvestrant"},{"type":"DRUG","name":"Arm C: Gedatolisib + Palbociclib + Letrozole"},{"type":"DRUG","name":"Arm D: Ribociclib + Letrozole"}],"enrollment":1180,"startDate":"2025-07-24","completionDate":"2029-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer\n2. Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.\n3. Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.\n4. Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.\n5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.\n6. Permitted prior therapies:\n\n   1. (neo)adjuvant fulvestrant only if the treatment duration \\< 6 months\n   2. (neo)adjuvant chemotherapy\n   3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i\n\n   i. Study 1: if disease progression was on or within event occurred \\>6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment.\n\n   ii. Study 2: if disease progression event occurred \\>12 months after completion of CDK4/6 inhibitor portion of treatment.\n7. Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n9. Life expectancy of at least \\>6 months.\n10. Adequate bone marrow, hepatic, renal and coagulation function.\n\nExclusion Criteria:\n\n1. Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.\n2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.\n3. Prior treatment with systemic anticancer therapy for ABC\n4. Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.\n5. Known and untreated, or active, brain or leptomeningeal metastases\n6. History of clinically significant cardiovascular abnormalities\n7. Known, clinically significant ophthalmic conditions\n8. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis","locations":[{"facility":"St Bernards Medical Center","city":"Jonesboro","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CARTI Cancer Center","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Hematology Oncology Santa Monica","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Associates","city":"Redondo Beach","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Hospital - Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"BRCR Medical Center, Inc- Internal Medicine","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Medical Center, INC","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Health-Paducah Cancer Center","city":"Paducah","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Oncology Partners, P.A.","city":"Bethesda","state":"Maryland","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Massachusetts General Hospital Cancer Center","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health System","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine in Saint Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCL Health - 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Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment","Progression of disease during or within 12 months of completing (neo)adjuvant endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET","Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status","Permitted prior therapies:","(neo)adjuvant fulvestrant only if the treatment duration \\< 6 months","(neo)adjuvant chemotherapy"],"whoShouldSkip":["Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study","Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting","Prior treatment with systemic anticancer therapy for ABC","Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy","Known and untreated, or active, brain or leptomeningeal metastases","History of clinically significant cardiovascular abnormalities","Known, clinically significant ophthalmic conditions"],"whatHappens":"If you join, the listed intervention(s) are Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, or Arm C: Gedatolisib + Palbociclib + Letrozole. The registry lists allocation as randomized. This is a Phase 3, open-label, randomly assigned, clinical trial evaluating the how well it works and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,180 people at 239 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.722Z"},{"nctId":"NCT06759701","title":"Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study","officialTitle":"Pre-Surgical Tirzepatide-Assisted Weight Loss in Overweight and Obese Men With Intermediate Risk Prostate Cancer: A Pilot Feasibility Study","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer","conditions":["Diabetes","Prostate Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":30,"startDate":"2025-07-02","completionDate":"2026-12-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed adenocarcinoma of the prostate that is localized (no metastatic lesions or concerning lymph nodes 1cm or greater) based on prostate MRI and meets NCCN intermediate risk criteria (as follows):\n\n  * Clinical T2b-T2c or lower disease\n  * Gleason Grade group 2 or 3 on biopsy\n  * PSA ≤20 ng/mL\n  * Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist\n* Adult men \\>30 and \\< 75 years old\n* Currently diagnosed with Diabetes Mellitus and meet one of the following criteria for overweight or obesity:\n\n  * Body Mass Index (BMI) greater than or equal to 27 kg/m2\n  * Waist circumference (\\> 40 inches) -or-\n* Currently have a BMI greater or equal to 30 kg/m2 -or-\n* Currently have a BMI greater or equal to 27 kg/m2 with at least one weight-related condition, defined as one or more of the following:\n\n  * Hypertension: treated or with systolic blood pressure (SBP) ≥130 mmHg or diastolic blood pressure ≥80 mmHg\n  * Dyslipidemia: treated or with low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) \\<40mg/dL (1.0 mmol/L)\n  * Obstructive sleep apnea\n  * Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Functional Class I-III heart failure)\n\nExclusion Criteria:\n\n* Prostate cancer that meets factors as part of NCCN high and very high-risk criteria (as follows):\n\n  * pT3a or higher disease\n  * Grade group 4 or 5 adenocarcinoma of prostate\n* Presence of metastatic disease on imaging\n* A history of intentional or unintentional weight loss of more than 5kg within 90 days of screening\n* Any prior androgen deprivation, chemotherapy, surgery, or radiation for PCa\n* Previous or planned surgical treatment for obesity or use of a medication that promotes weight loss within 90 days before screening\n* Have renal impairment measured as estimated glomerular filtration rate (eGFR) \\<30 as determine using standard MD Anderson laboratory measures\n* Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility\n* Have had a history of chronic or acute pancreatitis\n* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years\n\n  * Note: Patients with MDD or generalized anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications\n* Have any of the following cardiovascular conditions within 3 months prior to study enrollment: acute myocardial infarction (MI), cerebrovascular accident (stroke), unstable angina, or hospitalization due to congestive heart failure (CHF)\n* Have NYHA Functional Classification IV CHF\n* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease, or any of the following, as determined by the central laboratory during screening: - alanine aminotransferase (ALT) level \\>3.0X the upper limit of normal (ULN) for the reference range or - alkaline phosphatase (ALP) level \\>1.5X the ULN for the reference range or - total bilirubin level \\>1.2X the ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: Participants with nonalcoholic fatty liver disease are eligible to participate in this trial if their ALT level is ≤3.0X the ULN for the reference range\n* Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome type 2\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix), other than prostate cancer, for less than 5 years\n* Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1R agonists\n* Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the investigator, may preclude the participant from following and completing the protocol\n* Have history of use of marijuana within 3 months of enrollment and unwillingness to abstain from marijuana use during the trial. Participants should also refrain from use of cannabidiol oil for the duration of the study\n* Have had a transplanted organ (corneal transplants \\[keratoplasty\\] allowed) or awaiting an organ transplant.","locations":[{"facility":"The University of Texas M. D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Justin Gregg, MD","phone":"(713) 792-3250","email":"jrgregg@mdanderson.org"}],"primaryOutcomes":["Safety and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":["tirzepatide"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Early phase 1: testing Tirzepatide for Diabetes","inPlainEnglish":"The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer","whoItsFor":["Ages 18 Years to any","Men only","Histologically confirmed adenocarcinoma of the prostate that is localized (no metastatic lesions or concerning lymph nodes 1cm or greater) based on prostate MRI and meets NCCN intermediate risk criteria (as follows):","Clinical T2b-T2c or lower disease","Gleason Grade group 2 or 3 on biopsy","Desires radical prostatectomy (open or robotic) for prostate cancer management and is a surgical candidate as determined by the treating urologic oncologist","Adult men \\>30 and \\< 75 years old","Currently diagnosed with Diabetes Mellitus and meet one of the following criteria for overweight or obesity:","Body Mass Index (body-mass index (BMI)) greater than or equal to 27 kg/m2"],"whoShouldSkip":["Prostate cancer that meets factors as part of NCCN high and very high-risk criteria (as follows):","pT3a or higher disease","Grade group 4 or 5 adenocarcinoma of prostate","Presence of metastatic disease on imaging","A history of intentional or unintentional weight loss of more than 5kg within 90 days of screening","Any prior androgen deprivation, chemotherapy, surgery, or radiation for PCa","Previous or planned surgical treatment for obesity or use of a medication that promotes weight loss within 90 days before screening"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. The goal of this clinical research study is to determine how well a tirzepatide-assisted weight loss program works before a prostatectomy in patients with intermediate risk prostate cancer","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.036Z"},{"nctId":"NCT06760819","title":"A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)","officialTitle":"A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Bayer","sponsorClass":"INDUSTRY","summary":"Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.\n\nIn this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).\n\nSolid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.\n\nThe trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.\n\nThe participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.\n\nDuring the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.","conditions":["Advanced Solid Tumors","HER2 Mutation"],"keywords":["Colorectal cancer","CRC","Biliary tract cancer","BTC","Bladder cancer","Cervical cancer","Endometrial cancer","Sarcoma","Gastrointestinal stromal tumor","GIST","Breast cancer","Gastrointestinal cancer","GI cancer","Gastric cancer","Esophageal cancer","Gallbladder cancer","Pancreatic cancer","Ovarian Cancer","Salivary cancer","Ampullary cancer","Urothelial cancer","HER2 mutant cancer"],"interventions":[{"type":"DRUG","name":"BAY2927088"}],"enrollment":111,"startDate":"2025-02-13","completionDate":"2029-02-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)\n* Participant must be ≥18 years of age or over the legal age of consent\n* Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments\n* Documented activating HER2 mutation\n* At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria\n\nExclusion Criteria:\n\n* Primary diagnosis of non-small cell lung cancer (NSCLC)\n* Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)\n* Active brain metastases\n* Uncontrolled, severe, intercurrent illness","locations":[{"facility":"UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital","city":"Birmingham","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope - Duarte Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute - Oncology Department","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit","city":"Detroit","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Profound Research -OMG - TriAtria Cancer Center","city":"Farmington Hills","state":"Michigan","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Cleveland Clinic - Oncology Department","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center - Texas Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gynecology Oncology clinic at UW Medical Center - Montlake","city":"Seattle","state":"Washington","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"UW Health Carbone Cancer Center","city":"Madison","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NSW Health - Blacktown Hospital","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University Hospital - Oncology Department","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre - Southport","city":"Southport","state":"Queensland","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth II Health Sciences Centre | Oncology","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre | Medical Oncology and Hematology","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute of the McGill University Health Centre | Women Health's Research Unit","city":"Montreal","state":"Quebec","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Peking University First Hospital - Oncology Department","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer Hospital - Oncology Department","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital - Oncology Department","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center - Oncology Department","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet Copenhagen University Hospital | Oncology Department","city":"Copenhagen","state":"Capital Region / Region Hovedstaden","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aarhus University Hospital | Oncology Department - Clinical Research Unit","city":"Aarhus N","state":"Central Denmark Region / Region Midtjylland","country":"Denmark","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Odense University Hospital | Svendborg Sygehus - Oncology Department","city":"Odense","state":"Region of Southern Denmark / Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Lyon Sud - Service oncologie medicale","city":"Pierre-Bénite","state":"Auvergne-Rhône-Alpes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Brest - Hopital La Cavale Blanche - service oncologie medicale","city":"Brest","state":"Brittany Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret - Service Oncologie","city":"Lille","state":"Hauts-de-France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale","city":"Bordeaux","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP","city":"Montpellier","state":"Occitanie","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)","city":"Villejuif","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale","city":"Reggio Emilia","state":"Emilia-Romagna","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica","city":"Milan","state":"Lombardy","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East (NCCHE) - Kashiwa Campus","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kindai University Hospital","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Koto-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital | Oncology","city":"Jongno -Gu","state":"Seoul","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital | Oncology","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center | Oncology","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center | Oncology","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Catala D'oncologia | Hospitalet | Oncologia","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oncologico Dr. Rosell S.L. | Oncologia","city":"Barcelona","state":"Catalonia","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall D Hebron | Oncologia Medica","city":"Barcelona","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad De Navarra | Madrid | Oncologia","city":"Madrid","state":"Madrid","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica","city":"Madrid","state":"Madrid","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Inselspital Bern - Universitätsklinik für Medizinische Onkologie","city":"Bern","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopitaux Universitaires de Geneve - Oncology Department","city":"Geneva","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bayer Clinical Trials Contact","phone":"0018888422937","email":"clinical-trials-contact@bayer.com"}],"primaryOutcomes":["Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","pancreatic-cancer","ovarian-cancer","bladder-cancer","stomach-cancer","cervical-cancer","endometrial-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","duarte-california","fort-myers-florida","boston-massachusetts","detroit-michigan","farmington-hills-michigan","cleveland-ohio","nashville-tennessee","houston-texas","seattle-washington","madison-wisconsin","blacktown-australia","sydney-australia","southport-australia","halifax-canada","toronto-canada","montreal-canada","beijing-china","changsha-china","shanghai-china","hangzhou-china","copenhagen-denmark","aarhus-n-denmark","odense-denmark","pierre-b-nite-france","brest-france","lille-france","bordeaux-france","montpellier-france","villejuif-france","reggio-emilia-italy","rome-italy","milan-italy","nagoya-japan","kashiwa-japan","sapporo-japan","sakai-japan","chuo-ku-japan","koto-ku-japan","jongno-gu-south-korea","seoul-south-korea","lhospitalet-de-llobregat-spain","barcelona-spain","madrid-spain","bern-switzerland","geneva-switzerland","zurich-switzerland"],"enrichment":{"headline":"Phase 2: testing BAY2927088 for Advanced Solid Tumors","inPlainEnglish":"Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.","whoItsFor":["Ages 18 Years to any","Participant must be ≥18 years of age or over the legal age of consent","Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments","Documented activating HER2 mutation","At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria"],"whoShouldSkip":["Primary diagnosis of non-small cell lung cancer (NSCLC)","Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)","Active brain metastases","Uncontrolled, severe, intercurrent illness"],"whatHappens":"If you join, the listed intervention(s) are BAY2927088. The registry lists allocation as randomized. Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 111 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.307Z"},{"nctId":"NCT06761170","title":"Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)","officialTitle":"Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Beth Israel Deaconess Medical Center","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\\[s\\] investigators aim to answer are:\n\n1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone?\n2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.\n\nResearchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention.\n\nParticipants will surgery and receive one of the two interventions.","conditions":["Stenosis of Trachea"],"keywords":["Stenosis of trachea","benign","spray cryotherapy"],"interventions":[{"type":"PROCEDURE","name":"Spray cryo therapy"},{"type":"PROCEDURE","name":"Standard of Care (SOC)"}],"enrollment":50,"startDate":"2025-06-02","completionDate":"2028-01-15","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.\n* 2\\. Stenotic airway of diameter \\< 1cm.\n\nExclusion Criteria:\n\n1. Complex stenosis, cartilage involvement (malacia or fracture).\n2. Patients with giant bullae (\\> a third of hemithorax) or bullae \\>3cm.\n3. Concurrent tracheoesophageal fistula, active tracheal malignancy.\n4. Presence of concomitant upper airway obstruction.\n5. Pregnancy","locations":[{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christine Conley","phone":"617-632-8386","email":"Cconley@bidmc.harvard.edu"}],"primaryOutcomes":["Need of re intervention"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: Spray cryo therapy for Stenosis of Trachea","inPlainEnglish":"The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\\[s\\] investigators aim to answer are: 1.","whoItsFor":["1\\. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space","2\\. Stenotic airway of diameter \\< 1cm"],"whoShouldSkip":["Complex stenosis, cartilage involvement (malacia or fracture)","Patients with giant bullae (\\> a third of hemithorax) or bullae \\>3cm","Concurrent tracheoesophageal fistula, active tracheal malignancy","Presence of concomitant upper airway obstruction"],"whatHappens":"If you join, the listed intervention(s) are Spray cryo therapy, or Standard of Care (SOC). The registry lists allocation as randomized. The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Boston. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.443Z"},{"nctId":"NCT06764693","title":"An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthritis","officialTitle":"Prospective Multi-country, Real-world, Multi-arm Study of Treatment PErsistence With RISankizumab in Psoriatic Arthritis (PERIS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake. This study aims to describe the long term usage and effectiveness with risankizumab (RZB) relative to other advanced therapeutic options for the management of PsA in daily clinical practice.\n\nRisankizumab is an approved drug for the treatment of psoriatic arthritis. The study will not be conducted in the United States, however it will be conducted in approximately 15 countries and include at least 900 and up to 1200 participants with a 2 to1 ratio of participant allocation between participants receiving risankizumab and participants receiving other advanced therapeutic agents.\n\nThe therapy is prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population, and indication. All study visits will occur during routine clinical practice and participants will be followed for 24 months.\n\nThere is expected to be no additional burden for participants in this study.","conditions":["Psoriatic Arthritis"],"keywords":["Risankizumab, Skyrizi"],"interventions":[],"enrollment":1200,"startDate":"2025-01-31","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease.\n* Participant must have demonstrated an inadequate response to at least 1 Disease-modifying antirheumatic drug (DMARD) (with max 50% Biologic DMARD-Inadequate Response); alternatively, participant must have demonstrated an intolerance to or contraindication for csDMARDs as determined by the investigator.\n\nExclusion Criteria:\n\n\\- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs).","locations":[{"facility":"Cer Instituto Médico /ID# 274445","city":"Quilmes","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Medico de Alta Complejidad San Isidro S.A. /ID# 274417","city":"San Isidro","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Río Cuarto /ID# 274421","city":"Río Cuarto","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Landesklinikum Stockerau /ID# 275618","city":"Stockerau","state":"Lower Austria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 275617","city":"Vienna","state":"State of Vienna","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Graz /ID# 273765","city":"Graz","state":"Styria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krankenhaus Der Barmherzigen Brueder Graz /ID# 273764","city":"Graz","state":"Styria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universite Libre de Bruxelles - Hopital Erasme /ID# 272763","city":"Anderlecht","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rhumaconsult Sprl /ID# 272797","city":"Charleroi","state":"Hainaut","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Reumacentrum Genk - Medisch Centrum Genk /ID# 272796","city":"Genk","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"ReumaClinic /ID# 272782","city":"Genk","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"OLV Ziekenhuis Aalst /ID# 274456","city":"Aalst","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven /ID# 272781","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Liege /ID# 272784","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Consultative Centre (Dcc) - 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Shuang Ho Hospital, Ministry of Health and Welfare /ID# 274352","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital /ID# 274896","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital /ID# 280714","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shari Chapman","phone":"844-663-3742","email":"shari.chapman@abbvie.com"}],"primaryOutcomes":["Number of participants that show persistence in treatment until 24 months"],"hasResults":false,"conditionSlugs":["als","psoriasis"],"drugSlugs":["risankizumab"],"locationSlugs":["quilmes-argentina","san-isidro-argentina","r-o-cuarto-argentina","stockerau-austria","vienna-austria","graz-austria","anderlecht-belgium","charleroi-belgium","genk-belgium","aalst-belgium","leuven-belgium","li-ge-belgium","sofiya-bulgaria","pleven-bulgaria","plovdiv-bulgaria","sofia-bulgaria","varna-bulgaria","ostrava-czechia","pilsen-czechia","nice-france","caluire-et-cuire-france","clermont-ferrand-france","chirolles-france","besan-on-france","arras-france","lille-france","montpellier-france","rennes-france","chambray-l-s-tours-france","limoges-france","montauban-france","boulogne-sur-mer-france","nantes-france","aix-en-provence-france","cannes-france","rouen-france","p-ronne-france","cr-teil-france","cahors-france","orl-ans-france","paris-france","valenciennes-france","corbeil-essonnes-france","amberg-germany","planegg-germany","hohen-neuendorf-germany","templin-germany","frankfurt-am-main-germany","wetzlar-germany","hanover-germany","kassel-germany","ratingen-germany","kaiserslautern-germany","trier-germany","p-ttlingen-germany","halle-germany","magdeburg-germany","l-beck-germany","rendsburg-germany","altenburg-germany","berlin-germany","braunschweig-germany","greifswald-germany","wuppertal-germany","p-trai-greece","athens-greece","voula-greece","heraklion-greece","alexandroupoli-greece","larissa-greece","ioannina-greece","thessaloniki-greece","dublin-ireland","elm-park-ireland","tralee-ireland","cork-ireland","kfar-saba-israel","ramat-gan-israel","tel-aviv-israel","haifa-israel","jerusalem-israel","nahariya-israel","rozzano-italy","milan-italy","naples-italy","rome-italy","ancona-italy","brescia-italy","campobasso-italy","catania-italy","chieti-italy","pisa-italy","siena-italy","udine-italy","poznan-poland","wroclaw-poland","dammam-saudi-arabia","riyadh-saudi-arabia","m-laga-spain","lorca-spain","vigo-spain","seville-spain","granada-spain","huelva-spain","madrid-spain","murcia-spain","new-taipei-city-taiwan","taichung-taiwan","taipei-taiwan"],"enrichment":{"headline":"An Ex-US Study to Assess Treatment Persistence With Risankizumab in Adult Participants With Psoriatic Arthr…","inPlainEnglish":"Psoriatic arthritis (PsA) is a type of arthritis (swelling and stiffness in the joints) that is frequently seen in trial participants who also have the skin condition psoriasis. It is caused by an overactive immune system where the body attacks healthy tissue by mistake.","whoItsFor":["Ages 18 Years to 75 Years","Participant with a clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening visit and fulfillment of ClASsification for Psoriatic ARthritis (CASPAR) at Baseline visit to confirm that the participant has active disease"],"whoShouldSkip":["\\- Participants demonstrated an inadequate response to three or more bDMARDs/targeted synthetic DMARDs (tsDMARDs)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,200 people at 132 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.584Z"},{"nctId":"NCT06764706","title":"Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to Severe Ulcerative Colitis","officialTitle":"A Prospective, Real-World Study EvalUating the EffectiveNess and Safety of RISankizumab in PatiEnts With Ulcerative Colitis (SUNRISE-UC)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately multiple sites across Germany and Austria.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 52 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.","conditions":["Ulcerative Colitis"],"keywords":["Ulcerative colitis","Risankizumab","SKYRIZI"],"interventions":[],"enrollment":200,"startDate":"2025-02-27","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis.\n* Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label.\n\nExclusion Criteria:\n\n* Participants previously exposed risankizumab\n* Participants who are currently participating in interventional research (not including noninterventional studies, post-marketing observational study (PMOS), or registry participation).","locations":[{"facility":"Universitaetsklinikum Heidelberg /ID# 275906","city":"Heidelberg","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Ernst Von Bergmann /ID# 278268","city":"Potsdam","state":"Brandenburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice Dr. Katharina Pfeifer /ID# 286373","city":"Wriezen","state":"Brandenburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Kempelmann /ID# 275726","city":"Tostedt","state":"Free and Hanseatic City of Hamburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologische Schwerpunktpraxis - Hannover /ID# 276701","city":"Hanover","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis fuer Gastroenterologie - Schwerin /ID# 275946","city":"Schwerin","state":"Mecklenburg-Vorpommern","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinisches Versorgungszentrum Ahaus /ID# 280966","city":"Ahaus","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastropraxis Bochum /ID# 281375","city":"Bochum","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katholisches Klinikum Bochum gGmbH /ID# 279486","city":"Bochum","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelisches Krankenhaus Kalk /ID# 276414","city":"Cologne","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Duesseldorf /ID# 280409","city":"Düsseldorf","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dres. Kamp & Partner /ID# 275904","city":"Minden","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Innere Medizin /ID# 280068","city":"Witten","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologische Gemeinschaftspraxis Im Loehr-Center Koblenz /ID# 275943","city":"Koblenz","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologische Schwerpunkt Praxis /ID# 279856","city":"Ludwigshafen am Rhein","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Johannes Janschek /ID# 275877","city":"Dresden","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Leipzig /ID# 276779","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gesellschaft für klinische Studien /ID# 275867","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Thomas Zeisler /ID# 277933","city":"Halle","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Studiengesellschaft Mitteldeutschland /ID# 275905","city":"Halle","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxisgemeinschaft Jerichow Schulze /ID# 275911","city":"Jerichow","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Jaqueline Schumann /ID# 276126","city":"Teuchern","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis im Medicum /ID# 275933","city":"Altenholz","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis S. Tetzlaff /ID# 275882","city":"Buedelsdorf","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. Guenther-Tritsch /ID# 275886","city":"Geesthacht","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diabetologie Dithmarschen /ID# 281104","city":"Heide","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Thormann & Dr. Bethge /ID# 275931","city":"Kiel","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis fuer Gastroenterologie - Lubeck /ID# 275903","city":"Lübeck","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fek - Friedrich-Ebert-Krankenhaus Neumunster /ID# 276105","city":"Neumünster","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Altenburger Land /ID# 283912","city":"Altenburg","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr. Jack Peter-Stein /ID# 276815","city":"Jena","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tumorzentrum Nordthuringen Medizinisches Versorgungszentrum /ID# 280072","city":"Nordhausen","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Heil & Mueller /ID# 275927","city":"Andernach","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 275884","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Facharztpraxis fur Gastroenterologie Karlshorst /ID# 277966","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice- Dr. Andreas Horn /ID# 281448","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologie im Muhlenbergviertel /ID# 275883","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dres. Schick/Wesenberg /ID# 275878","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Studien GbR /ID# 275920","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Drk Kliniken Berlin - Kopenick /ID# 276277","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Jeannette Schwenzer & Dr. Sven Gruengreiff /ID# 276089","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. Soellenboehmer /ID# 276183","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krankenhaus Waldfriede /ID# 275913","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. Spitz /ID# 275912","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dres. Bauer/Doerflinger /ID# 276093","city":"Freiburg im Breisgau","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Matthias Eichler /ID# 275875","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologie Rahlstedt /ID# 276408","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSGH Gastroenterologische Studiengesellschaft Herne GbR /ID# 275874","city":"Herne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterologe am Ettlinger Tor /ID# 279854","city":"Karlsruhe","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dres. Breitschwerdt/Glas/Gurtler /ID# 276057","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"MVZ Gastroenterologie Leverkusen /ID# 275901","city":"Leverkusen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastropraxis Magdeburg /ID# 275885","city":"Magdeburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bettenworth & Partner /ID# 275900","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pc Docs /Id# 275876","city":"Pirmasens","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dres. Rehbehn/Skusa /ID# 276090","city":"Solingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Markus Braunfels /ID# 277129","city":"Wesseling","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr. Schirin-Sokhan /ID# 276982","city":"Würselen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical Information Germany","phone":"49 611 1720 1520","email":"medinfo.germany@abbvie.com"}],"primaryOutcomes":["Percentage of Participants Achieving Symptomatic Remission Responder Per Partial Adapted Mayo Score"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["heidelberg-germany","potsdam-germany","wriezen-germany","tostedt-germany","hanover-germany","schwerin-germany","ahaus-germany","bochum-germany","cologne-germany","d-sseldorf-germany","minden-germany","witten-germany","koblenz-germany","ludwigshafen-am-rhein-germany","dresden-germany","leipzig-germany","halle-germany","jerichow-germany","teuchern-germany","altenholz-germany","buedelsdorf-germany","geesthacht-germany","heide-germany","kiel-germany","l-beck-germany","neum-nster-germany","altenburg-germany","jena-germany","nordhausen-germany","andernach-germany","berlin-germany","freiburg-im-breisgau-germany","hamburg-germany","herne-germany","karlsruhe-germany","leverkusen-germany","magdeburg-germany","m-nster-germany","pirmasens-germany","solingen-germany","wesseling-germany","w-rselen-germany"],"enrichment":{"headline":"Study to Assess Change in Disease Activity of Risankizumab Treatment in Adult Participants With Moderate to…","inPlainEnglish":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.","whoItsFor":["Ages 18 Years to any","Participants with an endoscopically confirmed diagnosis of moderate to severe ulcerative colitis","Participants initiating risankizumab at the investigator's discretion as part of their routine clinical care; the decision to administer risankizumab must be made prior to and independent of documentation for the study and according to the approved local label"],"whoShouldSkip":["Participants previously exposed risankizumab","Participants who are currently participating in treatment research (not including noninterventional studies, post-marketing watch-and-measure (no experimental treatment required) study (PMOS), or registry participation)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 57 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.573Z"},{"nctId":"NCT06764875","title":"A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer","officialTitle":"A Randomized, Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan Versus Trastuzumab, Chemotherapy, and Pembrolizumab for the First Line Treatment of HER2-positive Gastric Cancer (ARTEMIDE-Gastric01)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a Phase Ⅲ, randomized, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.","conditions":["HER2-positive Gastric Cancer","Gastroesophageal Junction Adenocarcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rilvegostomig"},{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Trastuzumab"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"5-fluorouracil"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Oxaliplatin"}],"enrollment":840,"startDate":"2025-03-01","completionDate":"2029-04-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. HER2 positive for gastric cancer on a tumor biopsy.\n2. PD-L1 combined positive score (CPS) ≥ 1.\n3. Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing.\n4. Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma.\n5. WHO or Eastern Cooperative Oncology Group performance status of 0 or 1.\n6. Have measurable target disease assessed by the Investigator based on RECIST v1.1.\n7. Have adequate organ and bone marrow function.\n8. LVEF ≥ 50% within 28 days before randomization.\n9. Adequate treatment washout period before randomization.\n\nExclusion Criteria:\n\n1. Lack of physiological integrity of the upper gastrointestinal tract.\n2. Known dihydropyrimidine dehydrogenase enzyme deficiency.\n3. Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label.\n4. History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence.\n5. Persistent toxicities caused by previous anti-cancer therapy.\n6. Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n7. Uncontrolled infection including tuberculosis and active hepatitis A infection.\n8. Uncontrolled infection requiring intravenous (IV) antibiotics, anti-virals, or antifungals.\n9. Recent receipt of live, attenuated vaccine.\n10. Chronic/active HBV or HCV infection unless controlled.\n11. Clinically significant cardiac or psychological conditions.\n12. Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.\n13. History of (non-infectious) ILD/pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n14. Lung-specific intercurrent clinically significant illnesses.\n15. Any active non-infectious skin disease requiring systemic treatment.\n16. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART).\n17. History of any of the following: drug-induced severe cutaneous adverse reaction.\n18. Any concurrent antic-ancer treatment with the exception of receptor activator of nuclear factor kappa-B ligand inhibitors.\n19. Have had major surgical procedure recently (excluding placement of vascular access) or recent significant traumatic injury or an anticipated need for major surgery during the study.\n20. 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anoi-vietnam","ho-chi-minh-city-vietnam","h-ch-minh-vietnam","viet-tri-vietnam","vinh-vietnam"],"enrichment":{"headline":"Phase 3: testing Rilvegostomig for HER2-positive Gastric Cancer","inPlainEnglish":"This is a Phase Ⅲ, randomly assigned, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the how well it works and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm.","whoItsFor":["Ages 18 Years to any","HER2 positive for gastric cancer on a tumor biopsy","PD-L1 combined positive score (CPS) ≥ 1","Provision of tumor tissue sample from recent biopsy adequate for HER2 and PD-L1 testing","Previously untreated, unresectable, locally advanced or metastatic gastric or GEJ adenocarcinoma","WHO or Eastern Cooperative Oncology Group performance status of 0 or 1","Have measurable target disease assessed by the Investigator based on RECIST v1.1","Have adequate organ and bone marrow function"],"whoShouldSkip":["Lack of physiological integrity of the upper gastrointestinal tract","Known dihydropyrimidine dehydrogenase enzyme deficiency","Contraindication to pembrolizumab or trastuzumab, contraindications to fluoropyrimidine (5-FU and capecitabine) or platinum (cisplatin and oxaliplatin) treatment as per local label","History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence","Persistent toxicities caused by previous anti-cancer therapy","Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring corticosteroid or anticonvulsant may be included in the study if they have recovered from the acute toxic effect of radiotherapy","Uncontrolled infection including tuberculosis and active hepatitis A infection"],"whatHappens":"If you join, the listed intervention(s) are Rilvegostomig, Trastuzumab deruxtecan, or Trastuzumab. The registry lists allocation as randomized. This is a Phase Ⅲ, randomly assigned, open-label, Sponsor-blinded, 3-arm, global, multicenter study assessing the how well it works and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 840 people at 259 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.360Z"},{"nctId":"NCT06767566","title":"Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery","officialTitle":"Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Utah","sponsorClass":"OTHER","summary":"The purpose of this study is to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting. Ketamine is expected to exert different kinetics during the physiologic state of post-pregnancy. The goal in conducting this study is to better understand the pharmacokinetics and pharmacodynamics of postpartum ketamine infusion. A secondary goal is to compare these kinetics to reproductive age matched controls and to assess sex differences in ketamine pharmacokinetics.\n\nThe peripartum group of this study will receive ketamine after cesarean delivery, while the control group will consist of non-pregnant female subjects and male subjects receiving the same infusion protocol.","conditions":["Pain","Postpartum Depression"],"keywords":["Cesarean Delivery"],"interventions":[{"type":"DRUG","name":"Ketamine (Ketalar)"}],"enrollment":50,"startDate":"2025-04-30","completionDate":"2027-12-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Peripartum Participants:\n\nInclusion Criteria\n\n* Cesarean delivery\n* Adults 18 years and older\n* Term delivery ≥ 37 weeks gestation anticipated at time of delivery\n* ASA PS 2 or 3\n* Able to provide informed consent\n* One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan.\n\nExclusion Criteria\n\n* Patient going under general anesthesia for cesarean delivery\n* Allergy to study medication (ketamine)\n* ASA PS 4 +\n* Contraindications to neuraxial anesthesia\n* Preterm delivery (\\<37 weeks gestation)\n* Anticipated fetal-neonatal complex care plan as indicated in the patient's chart\n* Patient history of ketamine or PCP abuse\n* Patient history of schizophrenia or psychosis\n* Patient history of liver or renal insufficiency\n* Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, or intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine\n* Participating in another pain or depression intervention trial\n* Undergoing hormonal or gender affirming therapies\n* Pre-eclampsia with severe features\n* Hemodynamic instability\n* Inability to participate in study procedures for any reason\n* Contraindicated medications use: oral antihypertensive medications (exclusion: hypertensive disorders of pregnancy), intravenous magnesium (exclusion: pre-eclampsia with severe features), ketamine/phencyclidine/psilocybins/any other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine/other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)\n\nControl Participants\n\nInclusion Criteria\n\n* Age 18 years and older\n* Sex: Male or Female\n* Able to provide informed consent\n* ASA PS 1, 2, or 3\n\nExclusion Criteria\n\n* Allergy to study medication (ketamine)\n* ASA PS 4 +\n* Inability to participate in study procedures for any reason\n* Patient history of ketamine or PCP abuse\n* Patient history of schizophrenia or psychosis\n* Patient history of liver or renal insufficiency\n* Patient history of uncontrolled hypertension, chest pain, arrhythmia, head trauma, intracranial hypertension, uncontrolled hyperthyroidism, or other contraindications to ketamine\n* Participating in another pain or depression intervention trial\n* Hemodynamic instability\n* Pregnant or pregnant within the last 6 weeks\n* Unwilling to provide urine sample for pregnancy testing (female controls)\n* Undergoing hormonal or gender affirming therapies\n* Contraindicated medications use: ketamine, phencyclidine, psilocybins, or other psychedelics (exclusion: ketamine or PCP abuse), lithium/valproate/carbamazepine/lamotrigine/haloperidol/chlorpromazine/fluphenazine/aripiprazole/clozapine, or other typical or atypical antipsychotic medications (exclusion: schizophrenia or psychosis)","locations":[{"facility":"Magee Womens Hospital of UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Natalie Bennion, MPH","phone":"385-209-1185","email":"natalie.bennion@utah.edu"},{"name":"Amy Monroe, MPH, MBA","phone":"412-609-6161","email":"a.monroe@utah.edu"}],"primaryOutcomes":["Maternal ketamine area under the curve (AUC)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["pittsburgh-pennsylvania","salt-lake-city-utah"],"enrichment":{"headline":"Phase 1: testing Ketamine (Ketalar) for Pain","inPlainEnglish":"This study wants to identify pharmacokinetics of postpartum ketamine infusion. This study will assess ketamine kinetics and metabolism in this setting.","whoItsFor":["Ages 18 Years to any","Peripartum Participants:","Adults 18 years and older","Term delivery ≥ 37 weeks gestation anticipated at time of delivery","One of the following must be met for inclusion: Not planning to breastfeed OR ketamine use indicated for pain management plan"],"whoShouldSkip":["Patient going under general anesthesia for cesarean delivery","Allergy to study medication (ketamine)","Contraindications to neuraxial anesthesia","Preterm delivery (\\<37 weeks gestation)","Anticipated fetal-neonatal complex care plan as indicated in the patient's chart","Patient history of ketamine or PCP abuse","Patient history of schizophrenia or psychosis"],"whatHappens":"If you join, the listed intervention(s) are Ketamine (Ketalar). The registry lists allocation as randomized. This study wants to identify pharmacokinetics of postpartum ketamine infusion.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.782Z"},{"nctId":"NCT06770582","title":"Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial","officialTitle":"Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.","conditions":["Non-Muscle Invasive Bladder Urothelial Carcinoma","Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma","Stage I Bladder Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Fluorouracil"},{"type":"DRUG","name":"Gemcitabine"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Mitomycin"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"RADIATION","name":"Radiation Therapy"}],"enrollment":160,"startDate":"2025-06-03","completionDate":"2032-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)/CT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.\n\n  * NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible\n* High grade T1 disease history that must meet at least ONE of the three criteria below:\n\n  * Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \\[CIS\\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.\n  * T1 with pathologic high-risk features (lymphovascular invasion \\[LVI\\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)\n  * Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)\n* Restaging TURBT must be performed and must meet ALL of the following criteria below:\n\n  * If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.\n  * All grossly visible papillary tumors must be removed\n\n    * Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial\n* No pure squamous cell carcinoma or adenocarcinoma of the bladder\n* No neuroendocrine (small or large cell) features\n* No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)\n* No prostatic urethral involvement\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n* Platelets ≥ 100,000 cells/mm\\^3\n* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 9 g/dl is acceptable)\n* Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels \\> 1.5 × institutional ULN\n* Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* All adverse events of their most recent therapy/intervention must have resolved to \\< grade 3 or returned to baseline prior to registration\n* No history of pelvic radiation therapy\n* No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed\n* No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation\n* No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \\[COVID\\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible\n* Patients must have recovered from acute cardiac illness\n* New York Heart Association Functional Classification II or better (New York Heart Association \\[NYHA\\] Functional Classification III/IV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n* No active infection requiring IV antibiotics\n* No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis\n* No history of allogeneic bone marrow transplant or prior solid organ transplant\n* No active tuberculosis\n* No evidence of hydronephrosis\n* No history of upper tract urothelial carcinoma within 24 months of registration\n* No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable\n* No history of allergic reaction to the drug excipients","locations":[{"facility":"Banner University Medical Center - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Rogers","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIS Cancer Center at San Joaquin Community Hospital","city":"Bakersfield","state":"California","country":"United 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Campus-Brookfield","city":"Brookfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Calumet Hospital-Chilton","city":"Chilton","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon","city":"Mequon","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Columbia Saint Mary's Hospital-Milwaukee Campus","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension All Saints Hospital-Spring Street-Racine","city":"Racine","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa","city":"Wauwatosa","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Medical Center - Weston","city":"Weston","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Research Institute of the McGill University Health Centre (MUHC)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)","city":"Québec","state":"Quebec","country":"Canada","status":"SUSPENDED","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Bladder intact event-free survival (BIEFS)","Global quality of life"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["tucson-arizona","fayetteville-arkansas","rogers-arkansas","springdale-arkansas","bakersfield-california","irvine-california","los-angeles-california","orange-california","edwards-colorado","newark-delaware","aventura-florida","gainesville-florida","miami-beach-florida","atlanta-georgia","chicago-illinois","danville-illinois","decatur-illinois","effingham-illinois","mattoon-illinois","normal-illinois","ofallon-illinois","springfield-illinois","urbana-illinois","ames-iowa","ankeny-iowa","clive-iowa","des-moines-iowa","pella-iowa","waukee-iowa","west-des-moines-iowa","kansas-city-kansas","overland-park-kansas","westwood-kansas","baton-rouge-louisiana","gonzales-louisiana","metairie-louisiana","boston-massachusetts","ann-arbor-michigan","brighton-michigan","canton-michigan","chelsea-michigan","kalamazoo-michigan","lansing-michigan","livonia-michigan","pontiac-michigan","wyoming-michigan","bemidji-minnesota","brainerd-minnesota","deer-river-minnesota","duluth-minnesota","hibbing-minnesota","sandstone-minnesota","virginia-minnesota","cape-girardeau-missouri","farmington-missouri","kansas-city-missouri","lees-summit-missouri","osage-beach-missouri","sainte-genevieve-missouri","st-louis-missouri","sullivan-missouri","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","chapel-hill-north-carolina","fargo-north-dakota","columbus-ohio","dublin-ohio","mansfield-ohio","marion-ohio","oklahoma-city-oklahoma","chadds-ford-pennsylvania","danville-pennsylvania","dickson-city-pennsylvania","erie-pennsylvania","farrell-pennsylvania","greensburg-pennsylvania","hershey-pennsylvania","lewisburg-pennsylvania","monroeville-pennsylvania","new-castle-pennsylvania","pittsburgh-pennsylvania","seneca-pennsylvania","washington-pennsylvania","wilkes-barre-pennsylvania","berlin-corners-vermont","burlington-vermont","charlottesville-virginia","mechanicsville-virginia","midlothian-virginia","richmond-virginia","south-hill-virginia","morgantown-west-virginia","appleton-wisconsin","ashland-wisconsin","brookfield-wisconsin","chilton-wisconsin","mequon-wisconsin","milwaukee-wisconsin","racine-wisconsin","wauwatosa-wisconsin","weston-wisconsin","montreal-canada","qu-bec-canada"],"enrichment":{"headline":"Phase 2: testing Cisplatin for Non-Muscle Invasive Bladder Urothelial Carcinoma","inPlainEnglish":"This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","whoItsFor":["Ages 18 Years to any","NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible","High grade T1 disease history that must meet at least ONE of the three criteria below:","T1 with pathologic high-risk features (lymphovascular invasion \\[LVI\\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)","Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)","Restaging TURBT must be performed and must meet ALL of the following criteria below:","If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT","All grossly visible papillary tumors must be removed"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cisplatin, or Computed Tomography. The registry lists allocation as randomized. This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 147 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.289Z"},{"nctId":"NCT06778135","title":"Neocortical Microarchitecture of Executive Function","officialTitle":"Neocortical Microarchitecture of Executive Function Using Large-scale Intracranial Electrophysiology","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.","conditions":["Parkinson Disease"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Temporary implatation of large-scale intracranial electrode."},{"type":"DEVICE","name":"brain electrode"}],"enrollment":15,"startDate":"2025-07-25","completionDate":"2027-10","sex":"ALL","minAge":"45 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation\n2. Aged 45-85\n3. Able to provide informed consent\n4. Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease.\n5. Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon.\n6. Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC.\n7. Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake.\n8. Able to tolerate 25 additional minutes of awake surgery.\n9. Able to participate and comply with tasks adequately, including instructions provided in English.\n\nExclusion Criteria:\n\n1. Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation.\n2. Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon.\n3. Inability to safely access the dorsal lateral prefrontal cortex for an entry location.\n4. Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing.\n5. Evidence of a clinically significant abnormality on preoperative imaging.","locations":[{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pamela David Gerecht, PhD","phone":"303-724-4134","email":"pamela.davidgerecht@cuanschutz.edu"}],"primaryOutcomes":["Measure the neural population representations of task parameters along, and within, the cortical layers."],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["aurora-colorado"],"enrichment":{"headline":"Not a traditional drug phase: Temporary implatation of large-scale intracranial electrode. for Parkinson Disease","inPlainEnglish":"This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain. A Neuropixels probe will be inserted into and removed from the brain of awake human patients who are undergoing awake Deep Brain Stimulation (DBS) surgery.","whoItsFor":["Ages 45 Years to 85 Years","Diagnosis of Parkinson's disease and refractory to medications requiring deep brain stimulation","Normal neuropsychiatric evaluation that includes tests of executive function demonstrating no greater than mild impairments, within expectation for Parkinson's disease","Medically able to undergo deep brain stimulation surgery as evaluated by study neurosurgeon","Surgical plan includes an entry point that can safely be placed in the dorsal lateral PFC","Able to tolerate awake deep brain stimulation surgery with a plan for the case to be done awake","Able to tolerate 25 additional minutes of awake surgery","Able to participate and comply with tasks adequately, including instructions provided in English"],"whoShouldSkip":["Moderate, or severe cognitive impairment as determined by a licensed neuropsychologist during routine neuropsychological evaluation","Inability to tolerate awake surgery as determined by the treating neurologist and study neurosurgeon","Inability to safely access the dorsal lateral prefrontal cortex for an entry location","Moderate or severe cognitive impairment or executive function deficits as determined by neuropsychological testing","Evidence of a clinically significant abnormality on preoperative imaging"],"whatHappens":"If you join, the listed intervention(s) are Temporary implatation of large-scale intracranial electrode., or brain electrode. The registry lists allocation as na. This study is being done to the determine the ability and utility of using the Neuropixels probes in the human brain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 15 people at Aurora. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.667Z"},{"nctId":"NCT06779617","title":"UMMS Sepsis Early Prediction Score (SEPSys) and RESCUE Score Combined Clinical Trial","officialTitle":"Full Title: Sepsis Early Prediction System Score (SEPSys Score) and RESCUE Score Multi-Site, Two-Intervention, Cluster-Randomized, Factorial Stepped-Wedge Pragmatic Clinical Trial at the University of Mayland Medical System","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"SINGLE","sponsor":"University of Maryland, Baltimore","sponsorClass":"OTHER","summary":"This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes by providing them with new risk scores. The primary outcome will be the time from when the risk score becomes elevated to when vital signs such as heart rate or blood pressure are measured, suggesting an increased awareness.","conditions":["Sepsis","Patient Deterioration"],"keywords":["Sepsis","Patient Deterioration","AI","Artificial Intelligence","Machine learning","Decision support","Clinical decision support","Early warning systems"],"interventions":[{"type":"DEVICE","name":"SEPSys"},{"type":"DEVICE","name":"RESCUE"}],"enrollment":150000,"startDate":"2026-02-01","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Hospital Unit Inclusion Criteria:\n\n* Units are part of a member hospital of the University of Maryland Medical System (UMMS)\n* Units treat inpatient patients\n* Units agree to participate in the study\n\nGeneral Encounter Inclusion Criteria:\n\n* Encounter is on a participating inpatient unit\n* Encounter is associated with a bedded patient in the hospital\n* Encounter is associated with an adult (at least 18 years of age at time of admission)\n\nAdditional SEPSys Encounter Inclusion Criteria:\n\n• Encounter has a SEPSys Score\n\nAdditional RESCUE Encounter Inclusion Criteria:\n\n• Encounter has a RESCUE Score\n\nExclusion Criteria:\n\nHospital Unit Exclusion Criteria:\n\n* Unit treats exclusively outpatients or is located in an outpatient setting\n* Unit treats primarily or exclusively pediatric patients (patients under the age of 18 years old)\n* Unit treats exclusively psychiatric patients\n\nAdditional SEPSys Encounter Exclusion Criteria:\n\n* Encounter is with OB for a normal delivery and the patient has yet to give birth. This encounter can become eligible once the patient has given birth.\n* Encounter is admitted with a diagnosis of sepsis\n* Sepsis was already diagnosed during the encounter\n\nThis encounter will have been eligible until the patient began showing clinical signs or symptoms of sepsis or received a diagnosis of sepsis. Once they have a diagnosis or clinical signs or symptoms of sepsis, their SEPSys Score will no longer be updated. Data will continue to be collected on time of laboratory orders and treatments.\n\nAdditional RESCUE Encounter Exclusion Criteria:\n\n• Encounter is admitted with a high RESCUE Score (RESCUE Score of 4)","locations":[{"facility":"University of Maryland Medical Center - Midtown","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Upper Chesapeake Medical Center","city":"Bel Air","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Shore Medical Center","city":"Easton","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Baltimore Washington Medical Center","city":"Glen Burnie","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Charles Regional Medical Center","city":"La Plata","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Capital Region Medical Center","city":"Largo","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland St. Joseph Medical Center","city":"Towson","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Samuel A Tisherman, MD","phone":"410-328-9114","email":"stisherman@som.umaryland.edu"},{"name":"Jason Heavner, MD","phone":"410-553-8240","email":"jason.heavner@umm.edu"}],"primaryOutcomes":["Time To Vital Sign Measurement"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland","bel-air-maryland","easton-maryland","glen-burnie-maryland","la-plata-maryland","largo-maryland","towson-maryland"],"enrichment":{"headline":"Not a traditional drug phase: SEPSys for Sepsis","inPlainEnglish":"This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call). The goal of this study is to improve provider awareness of a patient's risk of these two negative outcomes by providing them with new risk scores.","whoItsFor":["Ages 18 Years to any","Units are part of a member hospital of the University of Maryland Medical System (UMMS)","Units treat inpatient patients","Units agree to participate in the study","General Encounter who can join:","Encounter is on a participating inpatient unit","Encounter is associated with a bedded patient in the hospital","Encounter is associated with an adult (at least 18 years of age at time of admission)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are SEPSys, or RESCUE. The registry lists allocation as randomized. This study is designed to test two new risk scores - one designed to predict a patient's four-hour risk of developing sepsis and one designed to predict a patient's four-hour risk of deterioration (cardiac arrest, death, unplanned ICU transfer, or rapid response team call).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150,000 people at 8 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.254Z"},{"nctId":"NCT06780150","title":"A Study to Investigate Effects of Ocrelizumab Treatment on Neurofilament Light Chain (NfL) Levels and Participant Satisfaction in Participants With Multiple Sclerosis (MS)","officialTitle":"SurfSubQ - A Prospective Longitudinal Multicenter Observational Study to Investigate Neurofilament Light Chain Levels and Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Multiple Sclerosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ocrelizumab"}],"enrollment":842,"startDate":"2024-09-26","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of MS\n* RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024\n* First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab\n\nExclusion Criteria:\n\n* Participation in interventional studies investigating DMTs for MS\n* Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non interventional study (NIS) at the same study site\n* Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)\n* Severe psychiatric disability\n* Pregnant women","locations":[{"facility":"Uniklinik RWTH Aachen","city":"Aachen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gesundheitszentrum St. Marien GmbH","city":"Amberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sächsisches Krankenhaus Arnsdorf","city":"Arnsdorf","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuropraxis im Stadtpalais Dres. 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Lippert/Kausch","city":"Bogen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krankenhaus Buchholz Abt. Neurologie","city":"Buchholz","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Allgemeines Krankenhaus Celle / Klinik für Neurologie","city":"Celle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuropraxis Celle: Praxis für Neurologie & Psychatrie","city":"Celle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxisgemeinschaft Dres. Sylke Domke und Vasil Gjaurov","city":"Chemnitz","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"NeuroMed Campus Neurologische Gemeinschaftspraxis am St. Elisabeth Krankenhaus","city":"Cologne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Dr. med. Josef Leclaire und Dr. med. 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Torsten Sühnel","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologische Praxis Dr. Ehrlich","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinik Schleswig Holstein, Campus Lübeck","city":"Lübeck","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologie im Ulrichshaus Magdeburg","city":"Magdeburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Magdeburg","city":"Magdeburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuroplus Dres. Lennart Thilmann/ Patrick Thilmann","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Mannheim","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Giessen und Marburg","city":"Marburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. Leussink","city":"Meerbusch","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologie am Preußenmuseum","city":"Minden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologie München Nord","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum rechts der Isar der TU München","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis für Neurologie und Psychiatrie am Prinzregentenplatz","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herz-Jesu-Krankenhaus Hiltrup GmbH","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologisch-psychiatrische Praxis im A4","city":"Neu-Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. med. Bergmann","city":"Neuburg am Inn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie","city":"Neuruppin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Uhlig und Windsheimer","city":"Nuremberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologie Nürnberg-Eibach","city":"Nuremberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologie an der Hase","city":"Osnabrück","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Dres. Beckmann / Schlüter","city":"Öhringen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Facharztpraxis für Neurologie und Psychiatrie Dres Mattes/Stockert","city":"Pforzheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologisches Studienzentrum Artland","city":"Quakenbrück","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis für Neurologie","city":"Regensburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Dr. Stienker-Fisse & Dr. Fisse","city":"Remscheid","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"ZNS Südpfalz","city":"Rülzheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurologische Praxis Dr. Wagner","city":"Schwetzingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis für Neurologie, Psychiatrie und Psychotherapie","city":"Siegen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis für Neurologie und Psychiatrie","city":"Siegen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"EMSA - Zentrum für Neurologie?/?Psychiatrie?/?Neuroradiologie","city":"Singen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. med. Max Deist und Michael Ernst ?Sinsheim","city":"Sinsheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann","city":"Steglitz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. med. Andreas Kowalik, Arzt für Neurologie und Psychiatrie","city":"Stuttgart","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuropraxis Sotiriadis","city":"Stuttgart","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurozentrum Stuttgart Mitte Sophienstraße","city":"Stuttgart","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sauerlandklinik Hachen","city":"Sundern","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen, Zentrum für Neurologie","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nervenfachaerztliche Gemeinschaftspraxis Ulm","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuropraxis München Süd","city":"Unterhaching","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis für Neurologie, Psychiatrie und Epileptologie","city":"Weil der Stadt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. Michaela Krause","city":"Wolfratshausen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heinrich-Braun-Krankenhaus Städtisches Klinikum","city":"Zwickau","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inselspital-Universitaetsspital Bern","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellevue Medical Grop AG","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: ML45551 https://forpatients.roche.com/ No attachments to email below","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Number of Participants by Their Level of Satisfaction With Ocrelizumab SC After 12 Months Assessed Using TASQ-SC"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["aachen-germany","amberg-germany","arnsdorf-germany","aschaffenburg-germany","bad-soden-germany","bamberg-germany","berg-germany","berlin-germany","bochum-germany","bogen-germany","buchholz-germany","celle-germany","chemnitz-germany","cologne-germany","dortmund-germany","d-sseldorf-germany","eltville-germany","erbach-odenwald-germany","erlangen-germany","essen-germany","forchheim-germany","frankfurt-germany","freiburg-im-breisgau-germany","f-ssen-germany","giessen-germany","gladenbach-germany","g-nzburg-germany","halle-germany","hamburg-germany","hanover-germany","hennigsdorf-germany","herford-germany","hettingen-germany","ibbenbueren-germany","isselburg-germany","jena-germany","kiel-germany","leipzig-germany","l-beck-germany","magdeburg-germany","mannheim-germany","marburg-germany","meerbusch-germany","minden-germany","m-nchen-germany","m-nster-germany","neu-ulm-germany","neuburg-am-inn-germany","neuruppin-germany","nuremberg-germany","osnabr-ck-germany","hringen-germany","pforzheim-germany","quakenbr-ck-germany","regensburg-germany","remscheid-germany","r-lzheim-germany","schwetzingen-germany","siegen-germany","singen-germany","sinsheim-germany","steglitz-germany","stuttgart-germany","sundern-germany","t-bingen-germany","ulm-germany","unterhaching-germany","weil-der-stadt-germany","wolfratshausen-germany","zwickau-germany","bern-switzerland","zurich-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: testing Ocrelizumab for Multiple Sclerosis","inPlainEnglish":"The main purpose of the study is to evaluate participant satisfaction after administration of ocrelizumab subcutaneously (SC) after 12 months using the therapy administration satisfaction questionnaire subcutaneous (TASQ-SC).","whoItsFor":["Ages 18 Years to any","RMS and PPMS participants diagnosed according to the McDonald criteria of 2017 or revised McDonald criteria 2024","First treatment during the course of MS therapy with ocrelizumab SC according to the local prescribing information, regardless of the reason for starting treatment with ocrelizumab"],"whoShouldSkip":["Participation in treatment studies investigating DMTs for MS","Prior or simultaneous participation in CONFIDENCE or MoOzaRt (ISRCTN55332718) non treatment study (NIS) at the same study site","Prior treatment with rituximab (MabThera®) or ublituximab (Briumvi®)","Severe psychiatric disability"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 842 people at 93 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.969Z"},{"nctId":"NCT06781697","title":"InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression","officialTitle":"InTRavenous kEtAmine and immerSive virtUal Reality to Treat dEpression (TREASURE Trial): a Pilot, Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sunnybrook Health Sciences Centre","sponsorClass":"OTHER","summary":"Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people. There is therefore a need for new treatments which work quickly and effectively.\n\nOne such medication is called ketamine. Studies have shown that ketamine can treat symptoms of depression quickly. This quick action sets ketamine apart from many antidepressants that take weeks to show noticeable effects. One way that it may do this is by creating a transient sense or feeling of being separated from reality, such as seeing or hearing things that are not really there. Another way to create these same feelings is with virtual reality (VR), where a person can feel as though they are entering a 3-dimensional virtual computer-generated world by wearing a special headset or goggles with a computer inside.\n\nIn this study, all participants will receive standard ketamine treatments for depression. Half of the participants will also use a VR headset while receiving the ketamine treatments to see if ketamine and VR acting together provide a better treatment for symptoms of depression than ketamine alone.\n\nThis is a small pilot trial. The main purpose of this trial is to learn if it is possible to run a larger clinical trial comparing \"ketamine and VR\" with \"ketamine alone\", for adults with treatment-resistant depression. The researchers will study this by seeing how many participants take part in the study within 1-2 years, and how many complete the study treatments and tests. The researchers will also compare the two study groups to see if \"ketamine and VR\" provide a better treatment for symptoms of depression than \"ketamine alone\".","conditions":["Treatment Resistant Depression"],"keywords":["Depression","Ketamine","Virtual Reality","Treatment Resistant Depression"],"interventions":[{"type":"DRUG","name":"Ketamine"},{"type":"DEVICE","name":"Oculus VR headset"}],"enrollment":31,"startDate":"2026-05-03","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18, able to provide informed consent\n* Patient diagnosed with treatment-resistant depression\n* Outpatient recommended and approved by psychiatrist for ketamine treatment\n* Patients who are on IV ketamine and requiring at least 4 treatments of IV ketamine per course (prescribed by their physiatrist)\n* Cognitively alert, oriented, and able to watch immersive content and respond to questions\n* Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine devices, intrauterine systems, etc.)\n\nExclusion Criteria:\n\n* History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist\n* Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment\n* Current or recent (within past twelve months) documented diagnosis of moderate or severe substance use disorder including uncontrolled/active alcohol abuse excepting nicotine or caffeine\n* Previous ketamine use\n* Acute dementia/delirium\n* Acute risk of suicide at baseline, as determined by the study psychiatrist\n* Pregnancy/breastfeeding\n* Previous sensitivity to ketamine or related compounds\n* Unstable medical condition which may require anesthesia consult\n* History of elevated intracranial pressure or cerebrovascular accident\n* Recent (within 6 weeks) major cardiovascular event (such as myocardial infarction)\n* Significant motion sickness (i.e. occur during exposure to physical/visual and virtual motion, cybersickness, etc.) self-identified by patient\n* Inability to communicate with the study team","locations":[{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fahad Alam, MD","phone":"416-480-4864","email":"fahad.alam@sunnybrook.ca"},{"name":"Peter Giacobbe, MD","phone":"416-480-4085","email":"peter.giacobbe@sunnybrook.ca"}],"primaryOutcomes":["Feasibility - Number of Participants who Complete at least 90% of Study Follow-ups","Feasibility - Time Required to Complete Enrolment"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 3: testing Ketamine for Treatment Resistant Depression","inPlainEnglish":"Depression is a common condition, with serious negative effects on the health and quality of life of those affected. While there are currently various medications which attempt to treat depression, they often take a long time to begin to work and do not work at all for many people.","whoItsFor":["Ages 18 Years to any","Patient diagnosed with treatment-resistant depression","Outpatient recommended and approved by psychiatrist for ketamine treatment","Patients who are on IV ketamine and requiring at least 4 treatments of IV ketamine per course (prescribed by their physiatrist)","Cognitively alert, oriented, and able to watch immersive content and respond to questions"],"whoShouldSkip":["History of psychosis/comorbid psychiatric disorders/psychotic depression/dissociative syndromes, significant personality disorder, as clinically assessed by psychiatrist","Using non-prescribed substance (e.g., cannabis) or alcohol use within the preceding 48 hours of treatment","Current or recent (within past twelve months) documented diagnosis of moderate or severe substance use disorder including uncontrolled/active alcohol abuse excepting nicotine or caffeine","Previous ketamine use","Acute dementia/delirium","Acute risk of suicide at baseline, as determined by the study psychiatrist","Pregnancy/breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Ketamine, or Oculus VR headset. The registry lists allocation as randomized. Depression is a common condition, with serious negative effects on the health and quality of life of those affected.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 31 people at Toronto. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.786Z"},{"nctId":"NCT06782412","title":"Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types","officialTitle":"Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"KU Leuven","sponsorClass":"OTHER","summary":"The aim of the project is to demonstrate superior detection ratio of \\[18F\\]AlF-FAPI-74 PET/CT compared to \\[18F\\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \\[18F\\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.","conditions":["Oesophageal Cancer","Gastric Cancer","Pancreatic Ductal Adenocarcinoma","FAP","Oncology","Oncologic Disorders"],"keywords":["Oesophagogastric adenocarcinoma","Pancreatic ductal adenocarcinoma","Clinically challenging situations","[18F]-FDG","[18F]-FAPI-74","[18F]AIF-FAPI-74","Positron emission tomography","PET","Nuclear imaging","Oncology","Prospective"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"[18F]AlF-FAPI-74 PET/CT"}],"enrollment":109,"startDate":"2025-02-06","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria OGA:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET/CT.\n5. TNM classification: cT1-4N0-3M0\n\nInclusion Criteria PDAC:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.\n4. Patient underwent a \\[18F\\]FDG PET/CT or conventional staging with CT or MRI.\n5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.\n\nInclusion Criteria Clinically challenging cohort:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.\n2. Age 18 or older.\n3. Histologic or cytologic proven diagnosis of a malignancy.\n4. Patient underwent a \\[18F\\]FDG PET/CT.\n5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.\n\nExclusion Criteria:\n\n1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.\n2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.\n3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).\n5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n7. Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients.","locations":[{"facility":"University Hospital Antwerp (UZA)","city":"Edegem","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Ghent","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.","Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)","Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting."],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["edegem-belgium","ghent-belgium","leuven-belgium"],"enrichment":{"headline":"Phase 2 / Phase 3: [18F]AlF-FAPI-74 PET/CT for Oesophageal Cancer","inPlainEnglish":"The aim of the project is to demonstrate superior detection ratio of \\[18F\\]AlF-FAPI-74 PET/CT compared to \\[18F\\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \\[18F\\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.","whoItsFor":["Ages 18 Years to any","New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma","Patient underwent a \\[18F\\]FDG PET/CT","TNM classification: cT1-4N0-3M0","who can join PDAC:","New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma","Patient underwent a \\[18F\\]FDG PET/CT or conventional staging with CT or MRI","TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients"],"whoShouldSkip":["Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures","Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol","Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial","Participation in an treatment Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team","Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv","Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients"],"whatHappens":"If you join, the listed intervention(s) are [18F]AlF-FAPI-74 PET/CT. The registry lists allocation as randomized. The aim of the project is to demonstrate superior detection ratio of \\[18F\\]AlF-FAPI-74 PET/CT compared to \\[18F\\]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of \\[18F\\]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 109 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.449Z"},{"nctId":"NCT06787612","title":"Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer","officialTitle":"Multi-Arm Phase 2 Platform Study of Ubamatamab (REGN4018; MUC16×CD3 Bispecific Antibody) With or Without Additional Agents in Platinum-Resistant Ovarian Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on participants who have advanced ovarian cancer.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is on its own and in combination with other anti-cancer drugs (bevacizumab, cemiplimab, fianlimab, REGN10597 and a standard chemotherapy drug, pegylated liposomal doxorubicin \\[PLD\\]), referred to as \"combination drugs'.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug and its experimental combinations\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) and its combinations","conditions":["Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer"],"keywords":["Cancer of the Fallopian Tube","Cancer of the Ovary","Fallopian Tube Carcinoma","Fallopian Tube Neoplasm","Fallopian Tube Neoplasms","Ovarian Carcinoma","Ovarian Neoplasms","Peritoneal Cancer","Peritoneal Neoplasms","Platinum Resistance","PPC","Primary Peritoneal Carcinoma"],"interventions":[{"type":"DRUG","name":"Ubamatamab"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Cemiplimab"},{"type":"DRUG","name":"Fianlimab"},{"type":"DRUG","name":"PLD"},{"type":"DRUG","name":"Sarilumab"},{"type":"DRUG","name":"REGN10597"}],"enrollment":397,"startDate":"2025-05-28","completionDate":"2028-06-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)\n2. Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n4. Adequate organ and bone marrow function, as described in the protocol\n5. Platinum-Resistant Ovarian Cancer, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)\n2. Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)\n3. Another malignancy that is progressing or requires active treatment, as described in the protocol\n4. Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol\n5. Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency\n6. Moderate to large or ascites, as described in the protocol\n7. Bowel obstruction within last 3 months or current need for parenteral nutrition\n\nNOTE: Other protocol-defined inclusion/exclusion criteria apply","locations":[{"facility":"The University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Sylvester Comprehensive Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advent Health Cancer Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital Cancer Institute","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute, St. Matthews Clinic","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Comprehensive Cancer Center","city":"Hilliard","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Cancer Institute","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center, Magee-Womens Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Penn Hospital of Allegheny Health Network","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute Sioux Falls","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CancerCare Manitoba","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Santé et de Services Sociaux de la Montérégie-Centre","city":"Greenfield Park","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute - McGill University Health Centre","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Quebec - Universite Laval","city":"Québec","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center","city":"Gyeonggi-do","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Incheon","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center, Univ. of Ulsan","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gangnam Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital","city":"Changhua","state":"Changhua City","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chi Mei Medical Center","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mackay Memorial Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tri-Service General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Municipal Wan Fang Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medicalpark Seyhan Hospital","city":"Seyhan","state":"Adana","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe University","city":"Altındağ","state":"Ankara","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medipol University Hospital","city":"Istanbul","state":"Bagcilar","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ege Universitesi Tip Fakultesi Hastanesi","city":"Bornova","state":"İzmir","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gaziantep Medicalpoint Hospital","city":"Gaziantep","state":"Sehitkamil","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baskent University","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sbu Doctor Abdurrahman Yurtaslan Ankara Onkoloji Suam","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent City Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Ankara Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cerrahpasa Medical Faculty At Istanbul University Cerrahpasa","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sakarya University - Education and Research Hospital","city":"Sakarya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator assessment"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","la-jolla-california","los-angeles-california","jacksonville-florida","miami-florida","orlando-florida","tampa-florida","chicago-illinois","westwood-kansas","louisville-kentucky","boston-massachusetts","detroit-michigan","hilliard-ohio","portland-oregon","pittsburgh-pennsylvania","sioux-falls-south-dakota","dallas-texas","seattle-washington","madison-wisconsin","milwaukee-wisconsin","winnipeg-canada","toronto-canada","greenfield-park-canada","montreal-canada","qu-bec-canada","gyeonggi-do-south-korea","seongnam-si-south-korea","incheon-south-korea","daegu-south-korea","seoul-south-korea","changhua-taiwan","tainan-taiwan","taipei-taiwan","seyhan-turkey-t-rkiye","alt-nda-turkey-t-rkiye","istanbul-turkey-t-rkiye","bornova-turkey-t-rkiye","gaziantep-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","izmir-turkey-t-rkiye","sakarya-turkey-t-rkiye"],"enrichment":{"headline":"Phase 2: testing Ubamatamab for Ovarian Cancer","inPlainEnglish":"This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\". The study is focused on participants who have advanced ovarian cancer.","whoItsFor":["Ages 18 Years to any","Women only","Participants with histologically or cytologically confirmed diagnosis of advanced serous or endometrioid ovarian (regardless of the grade), primary peritoneal, or fallopian tube cancer (clear cell, mucinous, and carcinosarcoma are excluded)","Must have progression on prior therapy documented radiographically and must have at least 1 measurable lesion (not previously irradiated) that can be accurately measured by RECIST 1.1","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Adequate organ and bone marrow function, as described in the protocol","Platinum-Resistant Ovarian Cancer, as described in the protocol"],"whoShouldSkip":["Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study intervention(s)","Documented allergic or acute hypersensitivity reaction attributed to antibody treatments or doxorubicin hydrochloride or components of study intervention(s)","Another malignancy that is progressing or requires active treatment, as described in the protocol","Untreated or active Central Nervous System (CNS) metastases, or carcinomatous meningitis, as described in the protocol","Uncontrolled infections including but not limited to human immunodeficiency virus, hepatitis B or hepatitis C infection, or diagnosis of immunodeficiency","Moderate to large or ascites, as described in the protocol","Bowel obstruction within last 3 months or current need for parenteral nutrition"],"whatHappens":"If you join, the listed intervention(s) are Ubamatamab, Bevacizumab, or Cemiplimab. The registry lists allocation as randomized. This study is researching an experimental drug called ubamatamab, also referred to as \"study drug\".","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 397 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.174Z"},{"nctId":"NCT06788249","title":"Pilot Study: Establishing Glutamatergic Changes in Rapid Antidepressant Effects of Ketamine","officialTitle":"Establishing Glutamatergic Changes as the Mechanism of Action in the Rapid Antidepressant Effects of Ketamine","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"In the treatment of Major Depressive Disorder (MDD), ketamine can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained efficacy, a better understanding of the mechanism of action is urgently needed. One candidate mechanism is the modulation of synaptic strength mediated by glutamatergic activity as ketamine has been suggested to increase synaptic strength. Although determining how ketamine impacts the glutamatergic system is essential to isolating its mechanism of action, the invasive nature of most assessment methods has limited our ability to do so in humans. The proposed research aims to determine if changes in glutamatergic activity, reflecting the modulation of synaptic strength, underlie the antidepressant effects of ketamine. In this project, the investigators will utilize a novel measure of glutamate imaging, GluCEST, to assess changes in glutamatergic activity to assess synaptic strength following ketamine administration. Ten individuals (aged 25-65) with a DSM-V diagnosis of MDD will undergo baseline GluCEST imaging prior to and following ketamine infusion. Both clinician-administered and subjective mood measures will be collected. It is predicted that ketamine will improve mood and increase glutamatergic activity and synaptic strength. Results from this project have the potential to identify the modifiable mechanisms by which rapid antidepressants work which could ultimately stimulate the development of novel interventions that work through the modulation of glutamatergic activity.","conditions":["Major Depressive Disorder (MDD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ketamine only"}],"enrollment":10,"startDate":"2026-04-01","completionDate":"2026-12-15","sex":"ALL","minAge":"25 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age between 25 and 65 years;\n2. Current depression as assessed on the SCID;\n3. Treatment-resistant depression, as defined by failure of at least two previous antidepressant or mood stabilizing treatments within the current depressive episode. Failed antidepressant or mood stabilizing treatments can include pharmacotherapy for depression at an adequate dose for at least 8 weeks\n4. Able to comprehend English, as all questionnaires are in this language\n5. Ability to provide informed consent Ability to pass a comprehension assessment test related to effects of ketamine and trial objectives and criteria.\n\nExclusion Criteria:\n\n1. A sleep disorder other than insomnia, as determined by history;\n2. History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as assessed on the SCID;\n3. Alcohol or drug abuse in the past year based upon the SCID or urine toxicology screen;\n4. A current smoker;\n\n4\\) Any significant medical or neurological illness that impacts brain function or impedes participation; 5) History of head trauma with significant loss of consciousness; 6) Metallic implants, pacemakers or tattoos, or other contraindications to MRI; Claustrophobic, or intolerant of the scanner environment; 7) For women, pregnancy will exclude participation. 8) Untreated hypertension\n\nBased on ketamine's known difficulties with induction of perceptual/psychomimetic symptoms, exclusion criteria for this study are as follows:\n\n1. Patients with a BMI over 40.\n2. Ongoing prescription of 4 mg lorazepam equivalents (total) daily, or morning dosing of any benzodiazepine at the time of assessment;\n3. Currently undergoing ECT, transcranial magnetic stimulation, vagal nerve stimulation, or deep brain stimulation as either an acute or maintenance treatment of depression;\n4. Use of any MAOI is prohibited two weeks prior to administration of study drug; if patients are on an MAOI when enrolled, study drug will not be administered until two weeks off MAOI;\n5. CYP3A4 inducers carbamazepine and modafinil are prohibited two weeks prior to administration of study drug and at least 24 hours after last dose of study drug.\n6. Current use of Naltrexone;\n7. Developmental delay, mental retardation, or intellectual disorder;\n8. Clinical or self-reported diagnosis of delirium, encephalopathy, or related clinical diagnosis within the prior 12 months;\n9. Prior participation in another study of ketamine for depression\n10. Prior treatment and/or recreational use of ketamine","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Isabel Koh","phone":"215-573-6173","email":"Isabel.Koh@PennMedicine.upenn.edu"},{"name":"Holly Barilla, MS","phone":"","email":"hbarilla@upenn.edu"}],"primaryOutcomes":["GluCEST imaging metrics"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Early phase 1: testing Ketamine only for Major Depressive Disorder (MDD)","inPlainEnglish":"In the treatment of Major Depressive Disorder (major depression), ketamine can produce rapid but short-lasting improvements in mood. In order to develop a new generation of treatments with rapid and sustained how well it works, a better understanding of the mechanism of action is urgently needed.","whoItsFor":["Ages 25 Years to 65 Years","Age between 25 and 65 years;","Current depression as assessed on the SCID;","Able to comprehend English, as all questionnaires are in this language"],"whoShouldSkip":["A sleep disorder other than insomnia, as determined by history;","History of bipolar disorder, delirium, dementia, amnestic disorder, schizophrenia and other psychotic disorders as assessed on the SCID;","Alcohol or drug abuse in the past year based upon the SCID or urine toxicology screen;","Based on ketamine's known difficulties with induction of perceptual/psychomimetic symptoms,"],"whatHappens":"If you join, the listed intervention(s) are Ketamine only. The registry lists allocation as na. In the treatment of Major Depressive Disorder (major depression), ketamine can produce rapid but short-lasting improvements in mood.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 10 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.788Z"},{"nctId":"NCT06788444","title":"Efficacy of Esketamine for Patients With Irritable Bowel Syndrome","officialTitle":"Efficacy of a Single Low Dose of Esketamine for Patients With Irritable Bowel Syndrome: Study Protocol for a Randomised Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Beijing Tiantan Hospital","sponsorClass":"OTHER","summary":"To explore the efficacy of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).","conditions":["Irritable Bowel Syndrome"],"keywords":["Irritable bowel syndrome","esketamine"],"interventions":[{"type":"PROCEDURE","name":"The colonoscopy"},{"type":"DRUG","name":"Esketamine"}],"enrollment":552,"startDate":"2025-02-08","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age of 18 - 60 years;\n2. American Society of Anesthesiologists (ASA) physical status of I - II;\n3. Body Mass Index (BMI) of 15 - 30;\n4. Scheduled for colonoscopy;\n5. Positive screening results according to the Rome IV diagnostic criteria for IBS;\n6. Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (MDD) .\n\nExclusion Criteria:\n\n1. GastrointestinalTract (GI) bleeding;\n2. Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；\n3. A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;\n4. A history of weight loss (at least 10%) within six months;\n5. A history of abdominal surgery (other than hernia repair or appendectomy);\n6. Participate in other clinical trials within 3 months;\n7. Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；\n8. Mental disorder patients with severe personality disorder, active suicidal ideation and history of self-harm within 1 year;\n9. Allergy or any contraindications to the drugs used in the study, such as severe cardiovascular disease, refractory hypertension, or hyperthyroidism;\n10. Drinking more than 50 units (1 unit refers to 10ml of pure alcohol) per week;\n11. Pregnancy or breastfeeding.","locations":[{"facility":"Beijing Tiantan Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The IBS Severity Scoring System (IBS-SSS)"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":["ketamine"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Esketamine for Irritable Bowel Syndrome","inPlainEnglish":"To explore the how well it works of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).","whoItsFor":["Ages 18 Years to 60 Years","Age of 18 - 60 years;","American Society of Anesthesiologists (ASA) physical status of I - II;","Body Mass Index (body-mass index (BMI)) of 15 - 30;","Scheduled for colonoscopy;","Positive screening results according to the Rome IV diagnostic criteria for IBS;","Patients who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Anxiety disorder (ANXD) and/or major depressive disorder (major depression)"],"whoShouldSkip":["GastrointestinalTract (GI) bleeding;","Any organic lesions confirmed by clinical examination, laboratory examination or colonoscopy；","A previous diagnosis of colon cancer, infammatory bowel disease or coeliac disease;","A history of weight loss (at least 10%) within six months;","A history of abdominal surgery (other than hernia repair or appendectomy);","Participate in other clinical trials within 3 months;","Patients older than 55 years of age who have not undergone a colonoscopy in the past 5 years；"],"whatHappens":"If you join, the listed intervention(s) are The colonoscopy, or Esketamine. The registry lists allocation as randomized. To explore the how well it works of a single low dose of esketamine for patients with irritable bowel syndrome (IBS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 552 people at Beijing. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.440Z"},{"nctId":"NCT06788522","title":"The Effects of Orexin Antagonism on Fear Extinction in PTSD","officialTitle":"The Effects of Orexin Antagonism on Fear Extinction in PTSD","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep. Treatments for PTSD are based on fear extinction principles in which individuals are repeatedly exposed a feared cue in the absence of danger, resulting in diminishing physiological reactions, a process believed to underlie recovery from PTSD. Studies suggest that orexin, a wake-promoting neuropeptide, may enhance fear extinction. This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia. Finding a role for orexins in fear extinction will support the rationale for its further evaluation in the treatment of PTSD. Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing symptoms in Veterans with PTSD.","conditions":["Insomnia","PTSD"],"keywords":["Fear conditioning","PTSD","Insomnia"],"interventions":[{"type":"DRUG","name":"Suvorexant"},{"type":"DRUG","name":"Placebo"}],"enrollment":40120,"startDate":"2026-07-01","completionDate":"2032-03-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* (same for Phase 1 and Phase 2):\n\n  * men and women\n  * a history of US military service\n  * capable of reading and understanding English\n  * able to provide written informed consent\n* Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma\n* Chronic full PTSD diagnosis \\>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \\> 30\n* Insomnia indicated by insomnia severity index (ISI) score \\> 14\n* Subjects on non-exclusionary medications, and must be on a stable dose for at least 4 weeks prior to randomization, including Selective Serotonin Reuptake Inhibitors (SSRIs, e.g.,):\n\n  * sertraline\n  * paroxetine\n  * fluoxetine\n  * fluvoxamine\n  * citalopram\n  * escitalopram\n* Serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g.):\n\n  * Desvenlafaxine\n  * Duloxetine\n  * Levomilnacipran\n  * Venlafaxine\n* For subjects who are in psychotherapy, treatment must be stable for 6 weeks\n* Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control\n\nExclusion Criteria:\n\n* Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months\n\n  * Mild alcohol use disorder with abstinence of 30 days will be allowed\n  * Mild marijuana use disorder will be allowed with abstinence for one week prior to participation\n  * Any other DSM-5 drug use disorder in the last 3 months will be excluded\n* Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features\n* Exposure to trauma in the last 3 months\n* Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication\n* Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or increased risk of suicide that necessitates additional therapy or inpatient treatment\n* Pre-existing moderate sleep apnea or positive screen for sleep apnea by type III device (AHI\\>15) in the absence of adherence to effective treatment (such as CPAP or oral device)\n* Night shift work or extreme morning or evening tendencies in order to avoid the impact of circadian factors on subjective and objective sleep measures\n* Neurologic disorder or systemic illness affecting CNS function\n* Chronic or unstable medical illness, including:\n\n  * unstable angina\n  * myocardial infarction within the past 6 months\n  * congestive heart failure\n  * preexisting hypotension or orthostatic hypotension\n  * heart block or arrhythmia\n  * chronic renal or hepatic failure\n  * pancreatitis\n  * severe chronic obstructive pulmonary disease\n* History of severe traumatic brain injury as assessed by the Ohio State University Traumatic Brain Injury Identification Method (OSU-TBI ID)\n* Uncorrected hearing impairment\n* Mild cognitive impairment assessed by the Montreal Cognitive Assessment (MOCA)\n* Pregnancy, breastfeeding and/or refusal to use effective birth control (for women)\n* Previous adverse reaction to a hypnotic\n* Current use of benzodiazepines, strong inhibitors of CYP3A, or Digoxin\n\n  * The investigators will require that all participants do not consume heavy amounts of alcohol per week (\\>7 drinks for women, \\>14 drinks for men) or use illicit drugs for one week prior to participation","locations":[{"facility":"San Francisco VA Medical Center, San Francisco, CA","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ralph H. Johnson VA Medical Center, Charleston, SC","city":"Charleston","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sabra S Inslicht, PhD","phone":"(415) 221-4810","email":"sabra.inslicht@va.gov"}],"primaryOutcomes":["Enrollment","Medication Adherence","Side effect reports","Post-randomization drop out","Fear conditioning and extinction","Rates of technical malfunction","Electrodermal Activity"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["san-francisco-california","charleston-south-carolina"],"enrichment":{"headline":"Phase 4: testing Suvorexant for Insomnia","inPlainEnglish":"PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep.","whoItsFor":["Ages 18 Years to 75 Years","(same for Phase 1 and Phase 2):","a history of US military service","capable of reading and understanding English","Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma","Chronic full PTSD diagnosis \\>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \\> 30","Insomnia indicated by insomnia severity index (ISI) score \\> 14","Subjects on non-exclusionary medications, and must be on a stable dose for at least 4 weeks prior to randomization, including Selective Serotonin Reuptake Inhibitors (SSRIs, e.g.,):"],"whoShouldSkip":["Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months","Mild alcohol use disorder with abstinence of 30 days will be allowed","Mild marijuana use disorder will be allowed with abstinence for one week prior to participation","Any other DSM-5 drug use disorder in the last 3 months will be excluded","Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features","Exposure to trauma in the last 3 months","Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication"],"whatHappens":"If you join, the listed intervention(s) are Suvorexant, or Placebo. The registry lists allocation as randomized. PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 40,120 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.407Z"},{"nctId":"NCT06790784","title":"Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of PDR","officialTitle":"A Randomized Clinical Trial Evaluating Combination Faricimab + PRP vs. Vitrectomy + Endolaser for Treatment of Proliferative Diabetic Retinopathy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Jaeb Center for Health Research","sponsorClass":"OTHER","summary":"This randomized trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser. The participants will be followed for 3 years. The study will evaluate long-term visual acuity as well as differences in number of injections, procedures, and complications during follow-up (after completion of randomization treatment), and cost.","conditions":["Proliferative Diabetic Retinopathy (PDR)"],"keywords":["faricimab","vitrectomy","endolaser","panretinal photocoagulation"],"interventions":[{"type":"PROCEDURE","name":"Vitrectomy"},{"type":"DEVICE","name":"Endolaser"},{"type":"DRUG","name":"Faricimab"},{"type":"DEVICE","name":"Panretinal Photocoagulation (PRP)"}],"enrollment":426,"startDate":"2025-08-04","completionDate":"2031-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nIndividual:\n\n* ≥ 18 years old\n* Diagnosis of diabetes mellitus (type 1 or type 2)\n\nStudy Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)\n\n* Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center\n* Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)\n\nExclusion Criteria:\n\n* Individual:\n\n  * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.\n  * Blood pressure \\> 160/100 (systolic above 160 or diastolic above 100).\n\n    o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible.\n  * For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.\n\n    * Women of childbearing potential will be required to have pregnancy testing or use an acceptable method of pregnancy prevention. Women who are potential study participants should be questioned about the potential for pregnancy at baseline and prior to each injection. Pregnancy test is required for all women of childbearing potential at baseline. Investigator judgment is used to determine when a pregnancy test is needed during follow up.\n\nStudy Eye: (A participant can have two study eyes.)\n\n* Traction retinal detachment involving the macula\n* Significant vitreous hemorrhage that would preclude completion of a full PRP\n* Significant vitreomacular traction\n* Any prior vitrectomy\n* Any prior PRP (defined as ≥100 burns outside of the posterior pole)\n* Treatment for DME within the prior 6 months\n* Intravitreal anti-VEGF for any indication, other than DME, within the prior year","locations":[{"facility":"Retina Associates of Southern California","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Coast Retina Medical Group, Inc.","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Retina Consultants","city":"Santa Barbara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida - Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Retina Consultants","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ophthalmic Partners of Florida, PA dba Central Florida Retina","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Florida, LLC","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Eye Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeast Retina Center, P.C.","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Eye Group","city":"Sandy Springs","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Retina Associates SC Oak Park Site","city":"Oak Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Eye Institute","city":"Carmel","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Trustees of Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolfe Clinic, P.C.- West Des Moines","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-America Retina Consultants, P.A.","city":"Overland","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky Advanced Eye Care","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana","city":"West Monroe","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elman Retina Group, P.A.","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center Corporation","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Joslin Diabetes Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Minnesota","city":"Saint Louis Park","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Research Institute, LLC","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Western NY, P.C.","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Center","city":"Edmond","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina-Vitreous Consultants, Inc.","city":"Monroeville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Research Center for Retina","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas, PA","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine, Baylor Eye Physicians and Surgeons","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cynthia Stockdale","phone":"8139758690","email":"drcrnet@jaeb.org"}],"primaryOutcomes":["Visual Acuity Change from Baseline","Number of Post-Randomization Treatments for Proliferative Diabetic Retinopathy"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["faricimab"],"locationSlugs":["huntington-beach-california","loma-linda-california","san-francisco-california","santa-barbara-california","jacksonville-florida","lakeland-florida","orlando-florida","tampa-florida","atlanta-georgia","augusta-georgia","sandy-springs-georgia","chicago-illinois","oak-park-illinois","carmel-indiana","indianapolis-indiana","west-des-moines-iowa","overland-kansas","lexington-kentucky","west-monroe-louisiana","baltimore-maryland","boston-massachusetts","rochester-minnesota","saint-louis-park-minnesota","st-louis-missouri","rochester-new-york","chapel-hill-north-carolina","edmond-oklahoma","monroeville-pennsylvania","austin-texas","bellaire-texas","dallas-texas","houston-texas","lubbock-texas"],"enrichment":{"headline":"Phase 3: testing Faricimab for Proliferative Diabetic Retinopathy (PDR)","inPlainEnglish":"This randomly assigned trial will compare treatment strategies for proliferative diabetic retinopathy (PDR). Participants will receive either combination a of faricimab + PRP or vitrectomy + endolaser.","whoItsFor":["Ages 18 Years to any","Diagnosis of diabetes mellitus (type 1 or type 2)","Study Eye:(A participant can have one or two study eyes if both eyes are eligible at screening.)","Presence of PDR requiring treatment, defined as moderate PDR or worse on global grading of ultrawide field fundus photos or NV meeting criteria for moderate PDR or worse on global grading of ultrawide field FA, confirmed by a central reading center","Best corrected visual acuity ≥49 letters (20/100 Snellen equivalent or better)"],"whoShouldSkip":["Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant","Blood pressure \\> 160/100 (systolic above 160 or diastolic above 100)","o If blood pressure is brought below 160/100 by anti-hypertensive treatment, individual can become eligible","For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years","Study Eye: (A participant can have two study eyes.)","Traction retinal detachment involving the macula","Significant vitreous hemorrhage that would preclude completion of a full PRP"],"whatHappens":"If you join, the listed intervention(s) are Vitrectomy, Endolaser, or Faricimab. The registry lists allocation as randomized. This randomly assigned trial will compare treatment strategies for proliferative diabetic retinopathy (PDR).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 426 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.129Z"},{"nctId":"NCT06792045","title":"Prediction of Tongue Base Obstruction During Sleep","officialTitle":"Tongue Motor Functions Assessment as a Screening Tool for Obstructive Sleep Disordered Breathing in Children","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Université Catholique de Louvain","sponsorClass":"OTHER","summary":"This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.","conditions":["Obstructive Sleep Disordered Breathing"],"keywords":["obstructive sleep disordered breathing","pediatrics","sleep","obstructive sleep apnea","snoring","tongue"],"interventions":[{"type":"OTHER","name":"Physiotherapist assessment"},{"type":"OTHER","name":"ENT assessment"},{"type":"DIAGNOSTIC_TEST","name":"Drug-Induced Sleep Endoscopy"}],"enrollment":48,"startDate":"2025-08-22","completionDate":"2027-10","sex":"ALL","minAge":"4 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 4 and 17 years old\n* Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids, excluding type III (e.g., linked to a neurological comorbidity)\n* Positive Pediatric Sleep Questionnaire (8 or more positive responses)\n* Eligibility for surgical intervention\n\nExclusion Criteria:\n\n* Previous surgery of the upper airway or oral cavity\n* History of or current head or neck cancer\n* Cranial, upper airway, or oral cavity malformation\n* Contraindication to performing the assessments","locations":[{"facility":"Cliniques universitaires Saint-Luc","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"William Poncin, Pr, Dr.","phone":"+32470592032","email":"william.poncin@uclouvain.be"},{"name":"Pierre Cnockaert, PT","phone":"","email":"cnockaert.kine@gmail.com"}],"primaryOutcomes":["Extent of tongue base obstruction"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["brussels-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Physiotherapist assessment for Obstructive Sleep Disordered Breathing","inPlainEnglish":"This study investigates the hypothesis that, in children, tongue motor functions can predict both the anatomical site and the degree of upper airway obstruction contributing to obstructive sleep-disordered breathing.","whoItsFor":["Ages 4 Years to 17 Years","Age between 4 and 17 years old","Medical diagnosis of obstructive sleep-disordered breathing requiring surgical removal of tonsils (partial or total) and/or adenoids, excluding type III (e.g., linked to a neurological comorbidity)","Positive Pediatric Sleep Questionnaire (8 or more positive responses)","Eligibility for surgical intervention"],"whoShouldSkip":["Previous surgery of the upper airway or oral cavity","History of or current head or neck cancer","Cranial, upper airway, or oral cavity malformation","Contraindication to performing the assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 48 people at Brussels. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.941Z"},{"nctId":"NCT06792721","title":"MEASUREMENT OF CIRCULATING MUTATION BURDEN","officialTitle":"EVALUATION OF CANCER RISK BY MEASUREMENT OF CIRCULATING MUTATIONAL BURDEN IN CARRIERS OF A GENETIC PREDISPOSITION","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre Francois Baclesse","sponsorClass":"OTHER","summary":"Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer","conditions":["Breast Carcinoma","Genetic Predisposition to Cancer","BRCA Mutation","cfMB","Mutation Burden"],"keywords":["cfMB","predisposition to cancer","BRCA1","BRCA2","breast cancer"],"interventions":[{"type":"GENETIC","name":"Mutation Burden cfMB analysis"}],"enrollment":30,"startDate":"2025-07-04","completionDate":"2029-07-15","sex":"FEMALE","minAge":"30 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Female participant\n* Participant undergoing oncogenetic follow-up at the Centre François Baclesse\n* Participant belonging to a pair of related biological siblings\n* Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control).\n* Participant between 30 and 50 years of age\n* Participant affiliated to a social security scheme\n* Participant having given her consent to participate by signing an informed consent form prior to any specific study-related procedure.\n\nExclusion Criteria:\n\n* Male gender\n* Current cancer or a history of cancer\n* Current smoker or someone who quit smoking less than 10 years ago with a cumulative exposure of \\> 10 packs/year)\n* Presence of another hereditary predisposition to cancer\n* History of risk-reduction surgery (adnexectomy, fimbriectomy, mastectomy)\n* Chronic immunomodulatory treatment\n* Patients who are incarcerated, under legal guardianship, subject to a legal protective measure, or unable to give informed consent\n* Patients unable to participate in the study for geographic, social, or psychopathological reasons","locations":[{"facility":"Centre François Baclesse","city":"Caen","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Louise May THIBAUT, Medical Doctor","phone":"0231455050","email":"lm.thibaut@baclesse.unicancer.fr"}],"primaryOutcomes":["Comparing the mutational burden in a person genetically predisposed to cancer with that of a non-predisposed relative"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer"],"drugSlugs":[],"locationSlugs":["caen-france"],"enrichment":{"headline":"Not a traditional drug phase: Mutation Burden cfMB analysis for Breast Carcinoma","inPlainEnglish":"Cancer-free women with a hereditary predisposition to breast and/or ovarian cancer","whoItsFor":["Ages 30 Years to 50 Years","Women only","Participant undergoing oncogenetic follow-up at the Centre François Baclesse","Participant belonging to a pair of related biological siblings","Within the sibling pair, one participant is a carrier of a hereditary predisposition linked to a BRCA1/2 mutation (case), and the other participant is not a carrier (control)","Participant between 30 and 50 years of age","Participant affiliated to a social security scheme"],"whoShouldSkip":["Current cancer or a history of cancer","Current smoker or someone who quit smoking less than 10 years ago with a cumulative exposure of \\> 10 packs/year)","Presence of another hereditary predisposition to cancer","History of risk-reduction surgery (adnexectomy, fimbriectomy, mastectomy)","Chronic immunomodulatory treatment","Patients unable to participate in the study for geographic, social, or psychopathological reasons"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Caen. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.957Z"},{"nctId":"NCT06793397","title":"A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder","officialTitle":"An Efficacy and Safety, Phase III, Multi-center, Double-Blind, Randomized Controlled Study Comparing 2 Active Doses of CYB003 and Placebo in Eligible Participants With Major Depressive Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Cybin IRL Limited","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to determine the efficacy, safety and tolerability of CYB003 compared to matching placebo as adjunctive treatment in patients with MDD.\n\nFor more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/","conditions":["Major Depressive Disorder (MDD)","Depression in Adults","Depression - Major Depressive Disorder","Depression Disorders","Depression Disorder","Depression"],"keywords":["MDD","Psychedelic","Depression","Major Depressive Disorder","CYB003","CYB003-001","CYB003-002","Psilocybin","psilocin-7438"],"interventions":[{"type":"DRUG","name":"CYB003"},{"type":"BEHAVIORAL","name":"Psychological Support"}],"enrollment":330,"startDate":"2025-12-10","completionDate":"2027-06-07","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all the following criteria to be included in the trial:\n\n* Age18 to 85 years.\n* Participant has a diagnosis of MDD (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first MDD episode must have occurred prior to age 60.\n* Moderate to severe depression at Screening and Baseline, independently confirmed.\n* Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator.\n* Participant has a body mass index (BMI) of 40 kg/m2 or less (BMI ≤40 kg/m2), inclusive, at Screening.\n* Participant is able to refrain from nicotine use during the dosing session (up to 8 hours).\n* Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential.\n* Participants of childbearing potential who have a partner capable of producing sperm must agree to use a highly effective method of contraception in combination with the use of a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication. Such participants must have a negative pregnancy test at Screening and Day 1 prior to dosing.\n* Participants of non-childbearing potential who are or were capable of producing eggs (ova) must have been postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.\n* Participants have provided written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form.\n\nExclusion Criteria\n\nParticipants with any of the following characteristics/conditions will be excluded from trial participation:\n\n* Current or previously diagnosed schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, brief psychotic disorder, current or previous history of bipolar disorder, or current borderline personality disorder.\n* Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD.\n* Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives).\n* Significant suicide risk within the past 6 months, during the Screening Period, or at Baseline; or (b) suicidal behaviors within 12 months of Screening; or (c) clinical assessment of significant suicidal risk during clinical interview; or (d) non-suicidal self-injury within 12 months of Screening.\n* Current or previous diagnosis of treatment-resistant MDD, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview.\n* Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of MDD in the last 6 months.\n* Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressants, mirtazapine, trazodone, moclobemide, buspirone, or an antipsychotic or mood stabilizer. Note: if receiving these medications are for another indication, they must be discontinued ≥ 14 days or 5 half-lives, whichever is longer, prior to Day 1.\n* Participant report of (or if available in medical record) exposure to psilocin, or 5-HT2a receptor agonists, or any other psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide, peyote, or 3,4-methylenedioxymethamphetamine, more than 10 times over the participant's lifetime or any psychedelic use within 12 months prior to Screening.\n* Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening.\n* Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder).\n* Has hypothyroidism or hyperthyroidism, unless controlled on appropriate medication.\n* Current diagnosis of uncontrolled hypertension or an arrhythmia, or clinically relevant abnormal results for heart rate.\n* Participants have a presence or relevant history of organic brain disorders.\n* Participant is taking or has taken OTC doses of 5-HTP or St John's Wort within prior to trial medication administration.\n* Donation of blood or plasma within 4 weeks prior to first dosing and until 4 weeks after final dosing.\n* Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 12 weeks after final dosing.\n* Participants of childbearing potential who are pregnant, breastfeeding, planning to conceive or unwilling to abstain from egg (ova) donation between first dosing and 12 weeks after final dosing.\n* History of serotonin syndrome.\n* Unwilling to consent to audio and video recording of psychological support and dosing sessions.","locations":[{"facility":"UAB Psychiatry and Behavioral Neurology","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lighthouse Psychiatry","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research - Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Behavioral Research Specialists, LLC","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Valley Research Center","city":"Imperial","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"CalNeuro Research Group","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lipov Medical Group","city":"Los Angeles","state":"California","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - Maitland","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aqualane Clinical Research","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research Tampa","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Dept of Psychiatry and Behavioral Studies","city":"Atlanta","state":"Georgia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Psych Atlanta","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush 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Saarlandes und Medizinische Fakultät der Universität des Saarlandes","city":"Homburg","state":"Saarland","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Charité Universitaetsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Frankfurt","city":"Frankfurt am Main","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Central Institute of Mental Health","city":"Mannheim","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Eginitio Hospital","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Attikon University Hospital","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Papageorgiou General 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Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Royal Liverpool Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"St Pancras Clinical Research","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clerkenwell Health - Welbeck Street","city":"London","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Re:Cognition Health","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clerkenwell Health - Baker Street","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edwardson Building - Campus for Ageing and Vitality","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascend Clinical Research","city":"Reading","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Health and Social Care NHS Foundation Trust","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Development","phone":"877-361-4003","email":"clinicaltrialsinfo@cybin.com"}],"primaryOutcomes":["Montgomery-Asberg Depression Scale (MADRS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["birmingham-alabama","gilbert-arizona","little-rock-arkansas","glendale-california","imperial-california","los-angeles-california","orange-california","san-juan-capistrano-california","santa-monica-california","stanford-california","new-haven-connecticut","jacksonville-florida","maitland-florida","naples-florida","tampa-florida","atlanta-georgia","marietta-georgia","chicago-illinois","marrero-louisiana","new-orleans-louisiana","baltimore-maryland","rockville-maryland","boston-massachusetts","watertown-massachusetts","eden-prairie-minnesota","golden-valley-minnesota","las-vegas-nevada","toms-river-new-jersey","new-york-new-york","the-bronx-new-york","oklahoma-city-oklahoma","philadelphia-pennsylvania","austin-texas","desoto-texas","fort-worth-texas","houston-texas","san-antonio-texas","everett-washington","seattle-washington","camperdown-australia","maroochydore-australia","melbourne-australia","notting-hill-australia","prague-czechia","p-edm-st-czechia","homburg-germany","berlin-germany","frankfurt-am-main-germany","mannheim-germany","athens-greece","thessaloniki-greece","dublin-ireland","galway-ireland","bialystok-poland","bydgoszcz-poland","gdansk-poland","warsaw-poland","cambridge-united-kingdom","doncaster-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","liverpool-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","reading-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing CYB003 for Major Depressive Disorder (MDD)","inPlainEnglish":"This study wants to determine the how well it works, whether it is safe and how hard side effects are to live with of CYB003 compared to matching dummy treatment (placebo) as added on top of your current treatment treatment in patients with major depression. For more information about the EMBRACE study, including participating study locations, and to register your interest in learning more about participation, please visit the study website: https://embrace-mdd-trial.com/","whoItsFor":["Ages 18 Years to 85 Years","Participants must meet all the following criteria to be included in the trial:","Participant has a diagnosis of major depression (single or recurrent episode as defined by DSM-5 TR \\[if single episode, duration of ≥4 weeks and ≤24 months\\] and established as per evaluation by the Investigator. The first major depression episode must have occurred prior to age 60","Moderate to severe depression at Screening and Baseline, independently confirmed","Participants have been on a stable dose of antidepressant medication (label specified) at an adequate dose in the last 4 weeks prior to Screening and has had an inadequate response (less than 50% improvement), as judged by the Investigator","Participant has a body mass index (body-mass index (BMI)) of 40 kg/m2 or less (body-mass index (BMI) ≤40 kg/m2), inclusive, at Screening","Participant is able to refrain from nicotine use during the dosing session (up to 8 hours)","Participants capable of producing sperm must use a condom plus spermicide during the trial and for 12 weeks after their final dose of trial medication, if their partner is a person of childbearing potential"],"whoShouldSkip":["Participants with any of the following characteristics/conditions will be excluded from trial participation:","Participants with a medical diagnosis of attention deficit hyperactivity disorder (ADHD) will be excluded if currently taking medication for ADHD","Family history of schizophrenia, schizoaffective disorder, or bipolar disorder type 1 (first-degree relatives)","Current or previous diagnosis of treatment-resistant major depression, defined as failure to respond to 2 or more antidepressant treatments of 2 different classes given at an adequate dose (label specified) for an adequate duration as judged by the Investigator and clinical interview","Has had electroconvulsive treatment, transcranial magnetic stimulation, deep brain stimulation, or vagal nerve stimulation for any episode of major depression in the last 6 months","Participant report of (or if available in medical record) treatment with ketamine or S-ketamine use within 6 months prior to Screening","Clinically relevant history of abnormal physical health interfering with the trial (including but not limited to, neurological, cardiovascular, respiratory, gastrointestinal \\[including dyspepsia or gastroesophageal reflux disease\\], hepatic, or renal disorder)"],"whatHappens":"If you join, the listed intervention(s) are CYB003, or Psychological Support. The registry lists allocation as randomized. This study wants to determine the how well it works, whether it is safe and how hard side effects are to live with of CYB003 compared to matching dummy treatment (placebo) as added on top of your current treatment treatment in patients with major depression.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 330 people at 79 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.095Z"},{"nctId":"NCT06799338","title":"Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France","officialTitle":"Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France: a Retrospective Observational Study (LENAddOn)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","sponsorClass":"OTHER","summary":"For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression. People with multidrug-resistant HIV-1 are at increased risk for hospitalization, progression to acquired immunodeficiency syndrome, and death.\n\nLenacapavir (LEN) is a first-in-class capsid inhibitor and has been evaluated through the CAPELLA phase 3 trial in PWH with replicative multidrug-resistant HIV-1. In this trial, LEN combined with an optimized background regimen (OBR) led to high levels of viral suppression, as more than 80% of participants achieved undetectable plasma HIV-RNA, associated with increasing in CD4 T cell counts.\n\nLEN has become publicly available in France from June 20, 2023, and prescriptions are discussed and validated by multidisciplinary committees in the hospitals, including HIV physicians, virologists and pharmacologists.\n\nFrom the time LEN was made publicly available in France, no real-world data have been generated to describe the real-world use of LEN, in association with an OBR, in various patient's profiles who may differ from the subjects included the CAPELLA trial.\n\nThus, investigators plan to conduct a national, multicenter, retrospective observational study to describe baseline socio-demographic, clinical and biological profiles of PWH receiving LEN + OBR in French real-world settings, to determine the continuation of LEN injections at weeks 26 and 52, and to determine the reasons for stopping LEN in case of no continuation of LEN injections.\n\nIn its current indication, LEN is reserved for a minority of PWH. However, France is the second-largest prescribing country for this drug, and one year after it was first marketed, it seems essential to review its use. Whether LEN injections are continued 6 and 12 months after starting treatment is a crucial question for understanding its use in treatment centers.\n\nLenacapavir has become publicly available in France in June 20, 2023. LEN prescriptions in France are discussed and validated by multidisciplinary committees, including HIV physicians, virologists and pharmacologists in the hospitals.","conditions":["HIV I Infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lenacapavir Injection"}],"enrollment":80,"startDate":"2025-03-03","completionDate":"2025-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (≥18 years);\n* With HIV-1 infection;\n* Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024;\n* Who did not refuse the collection and use of their data.\n\nExclusion Criteria:\n\n\\- HIV-2 infection.","locations":[{"facility":"Hôpital Pitié-Salpêtrière","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yasmine DUDOIT","phone":"+33 (0)1 42 16 41 81","email":"yasmine.dudoit@aphp.fr"},{"name":"Romain PALICH, MD","phone":"+33 (0)1 42 16 01 71","email":""}],"primaryOutcomes":["Measure the number of participants who received lenecapavir injection","Measure the number of participants who received a lenacapavir injection"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Lenacapavir Injection for HIV I Infection","inPlainEnglish":"For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression.","whoItsFor":["Ages 18 Years to any","Adults (≥18 years);","With HIV-1 infection;","Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024;","Who did not refuse the collection and use of their data"],"whoShouldSkip":["\\- HIV-2 infection"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Paris. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.402Z"},{"nctId":"NCT06801041","title":"TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","officialTitle":"TRIPS - Treatment to Improve Depression and/or Anxiety Using Psilocybin-assisted Psychotherapy in Cancer Survivors","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.","conditions":["Depression","Anxiety","Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Psilocybin"}],"enrollment":20,"startDate":"2025-05-23","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subjects must have solid or hematological malignancy that does not involve the brain.\n2. Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months\n3. Age ≥ 18 years.\n4. Have a DSM-V psychiatric diagnosis, as determined by the SCID (Structured Clinical Interview for DSM), of one or more of the following Axis I psychiatric disorders that is judged to have been precipitated by the psychological stress of the cancer diagnosis: Generalized Anxiety Disorder; Acute Stress Disorder; Posttraumatic Stress Disorder; Major Depressive Disorder, Dysthymic Disorder; Adjustment Disorder with Anxiety; Adjustment Disorder with Depressed Mood; Adjustment Disorder with Mixed Anxiety and Depressed Mood; Adjustment Disorder with Disturbance of Conduct; Adjustment Disorder with Disturbance of Emotions and Conduct. Psychiatric diagnoses are determined by. an MD Anderson licensed healthcare provider with graduate-level profession training and clinical experience in psychotherapy, licensed to practice independently.\n5. Have an ECOG performance status of 0, 1, or 2.\n6. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n7. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n8. Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance.\n9. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Patient tested positive for a prescribed substance are eligible. Patient failing on the 2nd test (UDS) will be excluded.\n10. Must be free from any regularly scheduled psychotropic (antidepressant/anxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n11. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n12. Eligible subjects will have a third-party transportation by a licenses driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n13. Fluent in Englishria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n\nExclusion Criteria:\n\n1. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   i. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline ii. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts iii. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self injurious behavior\n2. History of bipolar disorder, psychosis (including a history of schizophrenia).\n3. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n4. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n   * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n   * History of hysterectomy or bilateral salpingo-oophorectomy.\n   * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n   * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n5. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n6. Documentation of current malignancy that is being treated with palliative intent.\n7. Vulnerable populations, including children and cognitively impaired patients, will not be enrolled in this study.\n8. Patients with brain metastases.\n9. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) Blood Pressure \\>blood pressure \\>180/120mmHG, HR \\>110 bpm . Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n10. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial. Some examples include:\n\n    i. Uncompensated congestive heart failure ii. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450) iii. Recent acute myocardial infarction or evidence of ischemia iv. Malignant hypertension v. Congenital long QT syndrome vi. Acute renal failure vii. Severe hepatic impairment viii. Respiratory failure\n11. Significant central nervous system (CNS) pathology. Some examples include:\n\n    i. Primary or secondary cerebral neoplasm on imaging ii. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a one-time febrile seizure in childhood iii. History of stroke in the past 3 years iv. Untreated cerebral aneurysm v. Dementia vi. Ongoing delirium in which subjects would not have the capacity to participate in the study.\n\n12 a. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation. Examples include: i. Agitation ii. Violent behavior b. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year c. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses d. History of hallucinogen persisting perception disorder (HPPD) e. Concurrent Medications i. Antidepressants ii. Centrally-acting serotonergic agents (e.g., MAO inhibitors) iii. Antipsychotics (e.g., first and second generation) iv. Mood stabilizers (e.g., lithium, valproic acid) v. Aldehyde dehydrogenase inhibitors (e.g., disulfiram) vi. Significant inhibitors of UGT 1A0 or UGT 1A10 vii. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort) viii. efavirenz f. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\ni. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n\nii. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n\niii. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n\niv. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\ng. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin.\n\nh. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n\ni. Have an allergy or intolerance to any of the materials contained in the drug product.\n\nj. Be enrolled in another clinical trial assessing intervention(s) for anxiety, depression, and/or existential distress (e.g., pharmacologic or psychotherapeutic interventions).\n\n13\\. Patients with non-fMRI compatible implants will be eligible but will not have fMRI.","locations":[{"facility":"The University of Texas M. D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Moran Amit, MD, PHD","phone":"(713) 794-5304","email":"mamit@mdanderson.org"}],"primaryOutcomes":["Safety and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Psilocybin for Depression","inPlainEnglish":"This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.","whoItsFor":["Ages 18 Years to any","Subjects must have solid or hematological malignancy that does not involve the brain","Documentation of current malignancy that was treated and the patient has no evidence of disease in the previous 6 months","Have an how well you can do daily activities (ECOG score) of 0, 1, or 2","Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam)","Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments","Agree to abstain from any nicotine products for at least 8 hours prior to fMRI performance","Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin"],"whoShouldSkip":["Clinically significant suicidality or high risk of completed suicide defined as:","History of bipolar disorder, psychosis (including a history of schizophrenia)","Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating","Postmenopausal (no menses in greater than or equal to 12 consecutive months)","History of hysterectomy or bilateral salpingo-oophorectomy","Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy)","Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin. The registry lists allocation as na. This clinical research study is to learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy for cancer survivors with depression and/or anxiety.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.094Z"},{"nctId":"NCT06801184","title":"Single-center Exploratory Study of the Intestinal Microbiota in Patients Treated for Irritable Bowel Syndrome With Predominant Constipation and Methane Production","officialTitle":"Single-center Exploratory Study of the Intestinal Microbiota in Patients Suffering of Irritable Bowel Syndrome With Predominant Constipation and Methane Production: METHANOBIOTE","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hospices Civils de Lyon","sponsorClass":"OTHER","summary":"Irritable Bowel Syndrome (IBS), characterized by the Rome IV criteria, is a functional bowel disorder combining abdominal pain with changes in bowel habits and/or stool consistency. This condition is common, affecting 5% to 10% of the population in developed countries.\n\nThe etiology of IBS is multifactorial, involving intestinal motility disorders, visceral hypersensitivity, micro-inflammation of the intestinal mucosa, and dysbiosis. It has been demonstrated that the sub-category of IBS patients with constipation predominantly have increased amounts of Methanobrevibacter smithii, the most common methanogenic archaea found in the intestinal lumen, compared to other IBS patients.\n\nBreath tests can evaluate methane production by the intestinal microbiota, indirectly assessing the presence and quantity of methanogenic archaea. The acronym IMO (intestinal methanogen overgrowth) defines the association of digestive symptoms (notably bloating and constipation) with a high concentration of methane in exhaled gases (≥ 10 ppm).\n\nThe links between constipation, methane production, and fecal microbiota are uncertain, necessitating further studies that could lead to precise diagnostic and treatment recommendations.\n\nMain objective: Describe the initial composition of the fecal microbiota of constipated methano-producing IBS patients.\n\nSecondary objectives:\n\n2\\. Describe the initial composition of blood metabolites linked to the microbiota of constipated methano-producing IBS patients 3. Describe the evolution of the fecal microbiota and blood metabolites linked to the fecal microbiota during conventional therapeutic management (before and after) of constipated methano-producing IBS patients.\n\n4\\. Compare the composition of the fecal microbiota before and after conventional therapeutic management of responding IBS-C patients (-30% on the IBS-SSS symptom severity score) compared to non-responding patients.\n\n5\\. Evaluate the impact of Methanobrevicter smithii in the response to symptomatic treatment.\n\nExploratory observational single-center study (cohort follow-up) descriptive in patients with irritable bowel syndrome with constipation (IBS-C, IBS-m or IBS-U) with excessive methane production detected on a glucose breath test.\n\nPatients will be invited to participate once the results of the breath test are known.\n\nPlease note:\n\nIn the context of this study, only two microbiota samples and 4 additional tubes and one tube of blood will be added to the usual practice. All treatments will be prescribed as part of the care and are not conditioned by the research protocol.\n\nThe primary endpoint is the analysis of the initial composition (16S rRNA gene sequencing) of the fecal microbiota of constipated methano-producing IBS patients.\n\nThe study population consists of constipated IBS patients with excessive methane production seen in the digestive functional exploration department for a breath test prescribed as part of an external procedure or a day hospital session.\n\nA total of 40 patients will be included over 18 months, with a participation duration of 2 months +/- 2months per subject.\n\nPatients with IBS constitute a heterogeneous population for whom only symptomatic treatment is currently offered with variable and unpredictable efficacy. Through this work, we seek to find new therapeutic axes to relieve or even treat their symptoms.","conditions":["Irritable Bowel Syndrome"],"keywords":["gastroenterology","microbiota","Irritable Bowel Syndrome","constipation","methano-production"],"interventions":[{"type":"BIOLOGICAL","name":"Plasma Sample"},{"type":"BIOLOGICAL","name":"Stool Sample"}],"enrollment":40,"startDate":"2025-02-10","completionDate":"2028-10-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient suffering from Irritable Bowel Syndrome (IBS) (abdominal pain for the past 6 months occurring on average at least 1 day per week in the last 3 months, with at least 2 of the following criteria: associated with defecation, associated with a change in stool frequency, associated with a change in stool consistency):\n\n  1. Predominant constipation type (IBS-C): Bristol Stool Scale 1-2 ≥ 25% of the time and Bristol Stool Scale 6-7 ≤ 25% of the time\n  2. Alternating diarrhea-constipation type (IBS-M): Bristol Stool Scale 1-2 25% of the time and Bristol Stool Scale 6-7 25% of the time\n  3. Unspecified type: absence of sufficient criteria to meet criteria for IBS-C, IBS-D, or IBS-M.\n* Patient exhibiting a high methane level (≥ 10 ppm) during a glucose breath test.\n* Aged ≥ 18 years at the time of study entry.\n* Patient not opposing participation in the study.\n\nExclusion Criteria:\n\n* Patient who has been treated with antibiotics or probiotics in the last 3 months prior to inclusion.\n* Patient suffering from diarrhea-predominant IBS (Bristol Stool Scale 6-7 ≥ 25% of the time and Bristol Stool Scale 1-2 ≤ 25% of the time).\n* Patient with a history of abdominal surgery other than appendectomy and cholecystectomy.\n* Patient with a history of celiac disease.\n* Patient with proven inflammatory bowel disease.\n* Patient with a history of colorectal cancer.\n* Patient with uncontrolled hypothyroidism.\n* Patient with uncontrolled diabetes.\n* Pregnant or breastfeeding women.\n* Patient deprived of liberty by a judicial or administrative decision.\n* Adult patient under legal protection (guardianship, curators).\n* Patient unable to discontinue proton pump inhibitor treatment during the study period","locations":[{"facility":"Hôpital Edouard Herriot","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"François MION, Pr","phone":"4 72 11 01 36","email":"francois.mion@chu-lyon.fr"},{"name":"Nassira AMAMRA","phone":"4 72 11 51 25","email":"nassira.amamra@chu-lyon.fr"}],"primaryOutcomes":["Analysis of the initial composition (sequencing of the 16S rRNA gene) of the fecal microbiota in IBS patients with constipation and methane production."],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["lyon-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Plasma Sample for Irritable Bowel Syndrome","inPlainEnglish":"Irritable Bowel Syndrome (IBS), characterized by the Rome IV criteria, is a functional bowel disorder combining abdominal pain with changes in bowel habits and/or stool consistency. This condition is common, affecting 5% to 10% of the population in developed countries.","whoItsFor":["Ages 18 Years to any","Predominant constipation type (IBS-C): Bristol Stool Scale 1-2 ≥ 25% of the time and Bristol Stool Scale 6-7 ≤ 25% of the time","Alternating diarrhea-constipation type (IBS-M): Bristol Stool Scale 1-2 25% of the time and Bristol Stool Scale 6-7 25% of the time","Unspecified type: absence of sufficient criteria to meet criteria for IBS-C, IBS-D, or IBS-M","Patient exhibiting a high methane level (≥ 10 ppm) during a glucose breath test","Aged ≥ 18 years at the time of study entry","Patient not opposing participation in the study"],"whoShouldSkip":["Patient who has been treated with antibiotics or probiotics in the last 3 months prior to inclusion","Patient suffering from diarrhea-predominant IBS (Bristol Stool Scale 6-7 ≥ 25% of the time and Bristol Stool Scale 1-2 ≤ 25% of the time)","Patient with a history of abdominal surgery other than appendectomy and cholecystectomy","Patient with a history of celiac disease","Patient with proven inflammatory bowel disease","Patient with a history of colorectal cancer","Patient with uncontrolled hypothyroidism"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Lyon. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.443Z"},{"nctId":"NCT06804824","title":"A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors","officialTitle":"A Phase 1/1b, Open-Label, Multicenter, First-in-Human Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of VVD-159642, a RAS-PI3Kα Inhibitor, as a Single Agent and in Combination in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Vividion Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.","conditions":["Advanced Solid Tumors"],"keywords":["RAS","PI3K","KRAS","MEK","Phase I","solid tumors","KRAS G12C","HER2"],"interventions":[{"type":"DRUG","name":"VVD-159642"},{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Trametinib"}],"enrollment":220,"startDate":"2025-02-25","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* For Part 1 Dose Escalation, the prospective participant must have histologically confirmed pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), or any solid tumor that harbors a rat sarcoma viral oncogene (RAS) alteration \\[Kirsten rat sarcoma viral oncogene homolog (KRAS), neuroblastoma RAS viral oncogene homolog (NRAS), Harvey rat sarcoma viral oncogene homolog (HRAS)\\] as per local /historical testing; any solid tumor that harbors an epidermal growth factor receptor (EGFR) alteration as per local/historical testing; or human epidermal growth factor receptor 2 (HER2) overexpression (immunohistochemistry \\[IHC\\] 3+ or IHC 2+/fluorescence in situ hybridization \\[FISH\\] positive) as per local/historical testing.\n* Have histologically or cytologically confirmed metastatic or unresectable solid tumors.\n* Measurable disease by RECIST version 1.1 as assessed by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n* Adequate bone marrow, kidney, and liver function as defined in the protocol.\n* Able to take oral medications.\n\nKey Exclusion Criteria:\n\n* Active central nervous system (CNS) malignancies.\n* History of cardiac diseases as defined in detail in the protocol.\n* Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion).\n* History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study.\n* Active hepatitis B infection \\[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\\].\n* Active hepatitis C infection (positive anti-hepatitis C virus \\[HCV\\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay).","locations":[{"facility":"START Mid West","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Dallas","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research South Australia (CRSA)","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linear Clinical","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vividion Clinical Trial Call Center","phone":"858-345-9752","email":"clinicaltrials@vividion.com"}],"primaryOutcomes":["Part 1: Incidence and Severity of Dose-limiting Toxicities (DLTs)","Part 2: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)","Part 2: Incidence and Severity of Clinically Significant Changes in Vital Signs","Part 2: Incidence and Severity of Clinically Significant Changes in Laboratory Evaluations"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["sotorasib"],"locationSlugs":["grand-rapids-michigan","austin-texas","irving-texas","san-antonio-texas","ogden-utah","fairfax-virginia","adelaide-australia","nedlands-australia"],"enrichment":{"headline":"Phase 1: testing VVD-159642 for Advanced Solid Tumors","inPlainEnglish":"A FIH study to measure the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.","whoItsFor":["Ages 18 Years to any","Have histologically or cytologically confirmed metastatic or unresectable solid tumors","Measurable disease by RECIST version 1.1 as assessed by the investigator","Eastern Cooperative Oncology Group (ECOG) performance status ≤1","Adequate bone marrow, kidney, and liver function as defined in the protocol","Able to take oral medications"],"whoShouldSkip":["Active central nervous system (CNS) malignancies","History of cardiac diseases as defined in detail in the protocol","Uncontrolled arterial hypertension despite optimal medical management (per investigator's opinion)","History of inflammatory bowel disease or any malabsorption syndrome or any conditions that would interfere with enteral absorption and/or may interfere with the conduct of the study","Active hepatitis B infection \\[positive for hepatitis B surface antigen and Hepatitis B virus deoxyribonucleic acid (DNA)\\]","Active hepatitis C infection (positive anti-hepatitis C virus \\[HCV\\] antibody and quantitative HCV ribonucleic acid (RNA) results greater than the lower limits of detection of the assay)"],"whatHappens":"If you join, the listed intervention(s) are VVD-159642, Sotorasib, or Trametinib. The registry lists allocation as randomized. A FIH study to measure the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα) inhibitor, as a single agent and in combination with either sotorasib or trametinib in participants with advanced solid tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 220 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.973Z"},{"nctId":"NCT06806033","title":"Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL","officialTitle":"A Phase II, Open-Label, Multicenter Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab Monotherapy and Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab monotherapy treatment regimen (Cohort A), and for glofitamab monotherapy (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.","conditions":["Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma"],"keywords":["Phase 2","Outpatient study","Open-label","Glofitamab","Gemcitabine","Oxaliplatin","Obinutuzumab","GemOx","Glofit-GemOx","Bispecific antibody","Aggressive B-cell Non-Hodgkin's lymphoma","Diffuse Large B-Cell Lymphoma (DLBCL)","DLBCL NOS (Not Otherwise Specified)","High-Grade B-Cell Lymphoma (HGBL)","HGBL NOS","Transformed follicular lymphoma","DLBCL/HGBL with MYC and BCL2 rearrangements","Double-hit lymphoma","Relapsed or Refractory (R/R)","Non-Hodgkin Lymphoma (NHL)","Cytokine Release Syndrome (CRS)","CRS optimization","Step-up dosing"],"interventions":[{"type":"DRUG","name":"Obinutuzumab"},{"type":"DRUG","name":"Glofitamab"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Oxaliplatin"}],"enrollment":130,"startDate":"2025-03-05","completionDate":"2029-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Life expectancy \\>= 12 weeks.\n* For participants in the Glofit-GemOx combination therapy cohort (Cohort A) and the glofitamab monotherapy cohort (Cohort B), participant with histologically confirmed diffuse large B-cell lymphoma, (de novo or transformed from a follicular lymphoma (FL); participants with transformed FL must be relapsed or refractory (R/R) to standard therapies of transformed FL) with one of the following diagnoses according to World Health Organization, fifth edition (Alaggio et al. 2022). A fresh biopsy at study entry is not mandated. The histology can be confirmed based on fresh biopsy, or pathology report from a previous biopsy or an assessment of archival tumor tissue.\n\n  1. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS).\n  2. High-Grade B-Cell Lymphoma (HGBL), NOS.\n  3. DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements.\n* R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \\>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \\< 6 months after completion of the last line of therapy.\n* At least one line of prior systemic therapy.\n* Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant.\n* At least one bi-dimensionally measurable (\\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\\> 1 cm) extranodal lesion, as measured on CT scan.\n* Eastern Cooperative Oncology Group (ECOG) status of 0, 1, or 2.\n* According to the investigator's judgment, participants should be able to receive the step-up dose regimen in an outpatient setting.\n\nExclusion Criteria:\n\n* Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085).\n* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation.\n* Any history of Waldenstrom's macroglobulinemia.\n* Primary mediastinal B-cell lymphoma.\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products.\n* Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab. For participants in the monotherapy cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* For the Glofit-GemOx combination therapy cohort (Cohort A), prior treatment with gemcitabine or oxaliplatin.\n* For the Glofit-GemOx combination therapy cohort (Cohort A), peripheral neuropathy or paresthesia assessed to be Grade \\>= 2 according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 at enrolment.\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment.\n* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment.\n* Primary or secondary CNS lymphoma at the time of recruitment.\n* Prior CNS involvement that has been definitively treated and confirmed via magnetic resonance imaging (MRI) or cerebrospinal fluid analysis to be in complete remission is permissible.\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.\n* History of other primary malignancy, with exceptions defined by the protocol.\n* Significant or extensive cardiovascular disease.\n* Significant pulmonary disease (including moderate or severe obstructive pulmonary disease).\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection (as evaluated by the investigator) within 4 weeks prior to the first study treatment.\n* Positive for: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); tuberculosis; hepatitis B virus (HBV); hepatitis C virus (HCV); chronic active Epstein-Barr viral infection.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or progressive multifocal leukoencephalopathy.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better (with the exception of alopecia and anorexia).\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.\n* Prior solid organ transplantation or prior allogenic stem cell transplant.\n* Active autoimmune disease requiring treatment.\n* Prior treatment with systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents), within 4 weeks prior to first dose of study treatment.\n* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the participant at increased risk of steroid-related iatrogenic adrenal insufficiency.\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis.\n* Clinically significant history of cirrhotic liver disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the participant at high-risk from treatment complications.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after the final dose of study treatment.","locations":[{"facility":"Alaska Oncology & Hematology, LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Cancer Institute (CCI)","city":"Clovis","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Cancer Network","city":"Glendale","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Panorama City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zuckerberg San Francisco General Hospital","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers, LLP","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Florida/ South Georgia VA Medical Center","city":"Gainesville","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mount Sinai Comprehensive Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Luke?s Cancer Institute","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Central Illinois","city":"Swansea","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Blood and Cancer - MercyOne Cancer Center","city":"Waukee","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky - Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Bird Perkins Cancer Ctr","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Oncology Hematology, P.C.","city":"Albany","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology Oncology Associates of Central New York","city":"East Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates of Oregon, P.C","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Portland Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence St. Vincent Medical Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Scott & White Health","city":"Temple","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Gulf Coast","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology- Northeast Texas","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists, PC","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates - Virginia Beach","city":"Virginia Beach","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epworth Hospital","city":"East Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur J.E. Child Comprehensive Cancer Center","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CancerCare Manitoba (CCMB)","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Grenoble","city":"La Tronche","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu de Montpellier-St Eloi","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Bordeaux","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU DE RENNES - CHU Pontchaillou","city":"Rennes","state":"","country":"France","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Chu De Tours","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie","city":"Berlin","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Charite-Universitaetsmedizin Berlin - Campus Virchow-Klinikum (CVK)","city":"Berlin","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Universitätsklinikum Köln","city":"Cologne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Otto von Guericke Uni Magdeburg Uniklinik","city":"Magdeburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Nazionale Tumori Irccs Fondazione g. Pascale","city":"Naples","state":"Campania","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Romagnolo per lo studio dei tumori \"Dino Amadori\"","city":"Meldola","state":"Emilia-Romagna","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O. Spedali Civili Di Brescia-P.O. Spedali Civili","city":"Brescia","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irccs Istituto Europeo Di Oncologia (IEO)","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas","city":"Rozzano","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: GO45434 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Incidence of Cytokine Release Syndrome (CRS)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["anchorage-alaska","clovis-california","fullerton-california","glendale-california","los-angeles-california","panorama-city-california","san-francisco-california","torrance-california","aurora-colorado","gainesville-florida","miami-florida","orlando-florida","boise-idaho","swansea-illinois","waukee-iowa","lexington-kentucky","baton-rouge-louisiana","boston-massachusetts","grand-rapids-michigan","omaha-nebraska","albany-new-york","east-syracuse-new-york","eugene-oregon","portland-oregon","chattanooga-tennessee","nashville-tennessee","temple-texas","the-woodlands-texas","tyler-texas","fairfax-virginia","virginia-beach-virginia","tacoma-washington","east-melbourne-australia","calgary-canada","winnipeg-canada","la-tronche-france","montpellier-france","pessac-france","rennes-france","tours-france","berlin-germany","cologne-germany","magdeburg-germany","naples-italy","meldola-italy","brescia-italy","milan-italy","rozzano-italy","seongnam-si-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 2: testing Obinutuzumab for Relapsed or Refractory Aggressive B-Cell Non-Hodgkins Lymphoma","inPlainEnglish":"This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab this drug alone treatment regimen (Cohort A), and for glofitamab this drug alone (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.","whoItsFor":["Ages 18 Years to any","Life expectancy \\>= 12 weeks","Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified (NOS)","High-Grade B-Cell Lymphoma (HGBL), NOS","DLBCL/HGBL with myelocytomatosis proto-oncogene (MYC) and B-cell lymphoma 2 (BCL2) rearrangements","R/R disease, defined as: relapsed = disease that has recurred following a response that lasted \\>/= 6 months after completion of the last line of therapy; refractory = disease that did not respond to or that progressed \\< 6 months after completion of the last line of therapy","At least one line of prior systemic therapy","Participants who have failed one prior line of therapy (eligible to Cohort A) must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant"],"whoShouldSkip":["Prior enrollment in Studies GO41943 (NCT04313608), GO41944 (STARGLO; NCT04408638), or Study GO44900 (NCT06624085)","Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation","Any history of Waldenstrom's macroglobulinemia","Primary mediastinal B-cell lymphoma","History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products","Contraindication to obinutuzumab, gemcitabine or oxaliplatin, or tocilizumab. For participants in the this drug alone cohort (Cohort B), participants with contraindication to obinutuzumab or tocilizumab will be excluded","Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3"],"whatHappens":"If you join, the listed intervention(s) are Obinutuzumab, Glofitamab, or Gemcitabine. The registry lists allocation as randomized. This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) followed by glofitamab this drug alone treatment regimen (Cohort A), and for glofitamab this drug alone (Cohort B) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 130 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.146Z"},{"nctId":"NCT06807281","title":"A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema","officialTitle":"A Phase 3, Multicenter, Long-Term, Open Label Study Evaluating the Safety and Efficacy of Abrocitinib, With or Without Topical Medications Administered to Pediatric Participants Aged 2 Years and Older With Moderate-to-Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.","conditions":["Atopic Dermatitis"],"keywords":["eczema","atopic dermatitis"],"interventions":[{"type":"DRUG","name":"Abrocitinib"}],"enrollment":450,"startDate":"2025-12-02","completionDate":"2032-02-22","sex":"ALL","minAge":"2 Years","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for the Extension Cohort:\n\n1\\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \\<12 years old).\n\n• No contraception methods are required for male participants. Female participants must not be pregnant or breastfeeding and, if the participant is of child-bearing potential, must use a highly effective form of contraception (i.e., abstinence) during the study intervention period and for at least 28 days after the last dose of study intervention.\n\nInclusion Criteria for the De Novo Cohort:\n\nAge\n\n1. Children aged 6 to \\<12 years at the time of informed consent/assent.\n\n   • No contraception methods are required for male participants.\n\n   Disease Characteristics:\n2. Participants who meet all of the following AD criteria:\n\n   * A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and\n   * A diagnosis of moderate-to-severe AD at the baseline visit (must fulfill all of the following criteria: BSA ≥10%, vIGA ≥3, EASI ≥16, and WI-NRS ≥4); and\n   * Documented history (within 6 months of the screening visit) of inadequate response to treatment with topical medical therapy for AD (eg, TCS and TCI), for at least 4 weeks and are candidates for systemic therapy.\n\n   Other Inclusion Criteria:\n3. Body weight ≥15 kg\n\nExclusion Criteria for the Extension Cohort:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n\n   Prior/Concomitant Therapy:\n2. Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol.\n3. Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment.\n\n   Diagnostic Assessments:\n4. Ongoing adverse event in the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern OR the participant is currently triggering safety monitoring criteria.\n5. Discontinued from treatment early in the parent studies OR triggered a discontinuation criterion at any point during the parent studies OR meets exclusion criteria from the parent studies which in the opinion of the investigator, or sponsor, is an ongoing safety concern.\n\nExclusion Criteria for the De Novo Cohort\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   If the participant has SDQ total score ≥17, the investigator should exclude them or refer the child to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents.\n2. Have any of the following medical conditions:\n\n   * Infections:\n\n     * Skin infections that require treatment with systemic antimicrobials within 2 weeks prior to Day 1 (baseline) or have superficial skin infections within 1 week of Day 1.\n     * History of systemic infection requiring hospitalization or parenteral antimicrobial therapy or as otherwise judged clinically significant by the investigator within 1 month prior to Day 1.\n     * Have a history (single episode) of disseminated herpes zoster or disseminated herpes simplex, or a recurrent localized, dermatomal herpes zoster.\n     * Infection with HIV, hepatitis B, and/or hepatitis C\n     * Evidence of active TB or inadequately treated latent TB.\n   * Skin Conditions:\n\n     \\- Including but not limited to psoriasis, seborrheic dermatitis or lupus on Day 1 that would interfere with evaluation of AD or response to treatment.\n   * Other Conditions:\n\n     * Documented history of skeletal dysplasia.\n     * Documented history of retinal detachment.\n     * History of or conditions associated with thrombocytopenia, coagulopathy or platelet dysfunction.\n     * Prior history of leukemia, lymphoma, sarcoma or any other malignancy.\n     * Immunodeficiency disorder or a first-degree relative with a hereditary immunodeficiency.\n     * Any other medical conditions that in the investigator's judgment make the participant inappropriate for the study.\n\n   Prior/Concomitant Therapy:\n3. Prior treatment with a systemic JAK inhibitor for AD.\n4. Live attenuated vaccination within 6 weeks prior to Day 1 or require vaccination with live attenuated vaccines during treatment or within 6 weeks after the last dose of study intervention.\n5. Concomitant use of strong inhibitors and inducers of CYP2C19 enzymes and strong inducers of CYP2C9 enzymes is not allowed in the study.\n\n   Prior/Concurrent Clinical Study Experience:\n6. Previous administration of an investigational drug within 30 days or 5 half lives, whichever is longer, of Day 1.\n\n   Diagnostic Assessments:\n7. Hepatic and/or renal and/or hematological abnormalities defined as:\n\n   * AST \\>2 x ULN\n   * Hemoglobin \\<10 g/dL\n   * ALT \\>2 x ULN\n   * ANC \\<1000/mm3\n   * Total bilirubin ≥1.5 x ULN\n   * ALC \\<500/mm3\n   * eGFR \\<60 mL/min/1.73 m2\n   * Platelets \\<150,000 /mm3\n\n   Other Exclusion Criteria:\n8. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","locations":[{"facility":"Cahaba Dermatology & Skin Health Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Research Trials","city":"North Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Drug Service - Rady Childrens Hospital-San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego/ Rady Children's Hospital - San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Solutions Through Advanced Research","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ada West Research - Meridian","city":"Meridian","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Research Group, LLC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Louis University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina - South Carolina Translational Research Nexus Clinic","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tribe Clinical Research, LLC","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Dermatology and Laser Specialists","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Children's hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Children's Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Children's Hospital","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Hospital of Jiangxi Province","city":"Nanchang","state":"Jiangxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hangzhou Third People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Children's Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pécsi Tudományegyetem Klinikai Központ","city":"Pécs","state":"Baranya","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trial Pharma Kft.","city":"Békéscsaba","state":"Bekes County","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Szeged","city":"Szeged","state":"Csongrád-csanád","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinexpert Kft.","city":"Budapest","state":"Pest County","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen's square Medical Facilities Queen's square Dermatology and Allergology","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology and Ophthalmology Kume Clinic","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sasamoto Children's Clinic","city":"Setagaya-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka National Hospital","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saruta Dermatology Clinic","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Infantil de Mexico Federico Gomez","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Eukarya Pharmasite S.C.","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Arké SMO S.A de C.V","city":"Veracruz","state":"Veracruz Ignacio de LA Llave","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Servicios Hospitalarios de Mexico S.A. DE C.V.","city":"Chihuahua City","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy, Marek Brzewski, Paweł Brzewski spółka cywilna","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"LUXDERM Specjalistyczny Gabinet Dermatologiczny prof. dr hab. n. med. Dorota Krasowska","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Evimed","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"DERMAPOLIS Medical Dermatology Center dr n. med. Edyta Gebska","city":"Chorzów","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermedic Jacek Zdybski","city":"Ostrowiec Świętokrzyski","state":"Świętokrzyskie Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHUS - Hospital Clinico Universitario","city":"Santiago de Compostela","state":"A Coruña [LA Coruña]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General de Granollers","city":"Granollers","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Miguel Servet","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and adverse events (AEs) that lead to study discontinuation"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","north-little-rock-arkansas","san-diego-california","jacksonville-florida","meridian-idaho","indianapolis-indiana","st-louis-missouri","charleston-south-carolina","greenville-south-carolina","san-antonio-texas","beijing-china","shenzhen-china","changsha-china","nanchang-china","hangzhou-china","shanghai-china","p-cs-hungary","b-k-scsaba-hungary","szeged-hungary","budapest-hungary","yokohama-japan","sakai-japan","setagaya-ku-japan","fukuoka-japan","mexico-city-mexico","monterrey-mexico","veracruz-mexico","chihuahua-city-mexico","krakow-poland","lublin-poland","warsaw-poland","chorz-w-poland","lodz-poland","ostrowiec-wi-tokrzyski-poland","santiago-de-compostela-spain","granollers-spain","zaragoza-spain"],"enrichment":{"headline":"Phase 3: testing Abrocitinib for Atopic Dermatitis","inPlainEnglish":"This 24-month study will assess the long-term safety and how well it works of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.","whoItsFor":["Ages 2 Years to 11 Years","for the Extension Cohort:","1\\. Participants who have completed the treatment phase of the qualifying parent study (age 2 to \\<12 years old)","who can join for the De Novo Cohort:","No contraception methods are required for male participants","Disease Characteristics:","Participants who meet all of the following AD criteria:","A documented diagnosis of chronic AD for at least 6 months prior to screening and confirmed at screening and baseline visits according to the Hanifin and Rajka criteria; and"],"whoShouldSkip":["for the Extension Cohort:","Medical Conditions:","If the participant has SDQ total score ≥17, the investigator should exclude the child or refer them to a pediatric MHP to determine if it is safe to participate in the study. A copy or summary of the evaluation should be placed in the site source documents","Prior/Concomitant Therapy:","Required use of any prohibited concomitant treatments outlined in Section 6.9.3 and Appendix 9 of study protocol","Required vaccination with live attenuated vaccines during study treatment and for 6 weeks after discontinuing study treatment","Diagnostic Assessments:"],"whatHappens":"If you join, the listed intervention(s) are Abrocitinib. The registry lists allocation as randomized. This 24-month study will assess the long-term safety and how well it works of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 450 people at 40 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.824Z"},{"nctId":"NCT06807437","title":"Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula","officialTitle":"A Randomized Phase III Blinded Trial of Lanreotide for the Prevention of Postoperative Pancreatic Fistula","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"SWOG Cancer Research Network","sponsorClass":"NETWORK","summary":"This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous. Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It may help stop the body from making extra amounts of certain hormones, including growth hormone, insulin, glucagon, and hormones that affect digestion. It may also help keep certain types of tumor cells from growing. Patients with pancreatic cancer or pancreatic lesions may undergo surgery to remove parts of the pancreas, also called a distal pancreatectomy. Patients may experience complications after surgery, including pancreatic fistulas. A pancreatic fistula occurs when there is a small leak from the pancreas, causing fluids to collect. This can often lead to infection and other problems. Giving lanreotide before undergoing distal pancreatectomy may be more effective than surgery alone in preventing the development of a pancreatic fistula in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.","conditions":["Pancreatic Carcinoma","Pancreatic Neoplasm"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Distal Pancreatectomy"},{"type":"DRUG","name":"Lanreotide"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"OTHER","name":"Saline"}],"enrollment":274,"startDate":"2025-05-09","completionDate":"2029-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential\n* Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date\n* Participants must not have a known history of a prior diagnosis of malabsorption syndrome\n* Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization\n* Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization\n* Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization\n* Participants must be ≥ 18 years old\n* Participants must have a complete documented medical history and physical exam within 28 days prior to registration/randomization\n* Participants must have a creatinine ≤ the institutional upper limit of normal (IULN) OR a measured OR calculated creatinine clearance ≥ 50 mL/min using the following Cockcroft -Gault formula within 60 days prior to registration/randomization\n* Participants must complete a pre-registration screening to identify any of the medications below, allowing the study team and treating physician to develop a monitoring plan as needed. Participants taking medications with known interactions with lanreotide may remain eligible if appropriate monitoring and management are in place. These medications include:\n\n  * Diabetes medications (insulin or oral hypoglycemics): Blood sugar will be monitored, and medication dose adjustments made as needed\n  * Cyclosporine: Dosage adjustments may be required to maintain therapeutic levels\n  * Bromocriptine: Dose adjustments may be considered to account for absorption changes\n  * Heart medications (e.g., beta blockers): Heart rate will be monitored, and medication doses adjusted if necessary\n  * CYP3A4-metabolized medications: Dose adjustments may be considered to avoid increased exposure\n* In the opinion of the treating surgeon, based on preoperative data, the participant must not require a modified Appleby-type procedure (distal pancreatectomy with celiac axis resection) or multivisceral resection (e.g., stomach, colon, etc.) at the time of distal pancreatectomy\n\n  * NOTE: planned removal of the gallbladder or spleen at the time of distal pancreatectomy is not considered multivisceral resection and is permissible\n* In the opinion of the treating surgeon, based on preoperative data, the participant must not require a tumor enucleation\n* Participants must not have moderate to severe hepatic impairment as defined by liver enzyme elevation more than 5 times the institutional upper limit of normal (either aspartate aminotransferase \\[AST\\] \\> 190 U/L or alanine aminotransferase \\[ALT\\] \\> 320 U/L) within 60 days prior to registration/randomization. Transient elevation at the time of screening that resolves prior to study enrollment is acceptable\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped)\n* Individuals who are of reproductive potential must have agreed to use an effective contraceptive method during the whole period of the study and for three months after the study drug administration, with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete EORTC QLQ-C30, EORTC QLQ-PAN26, and EQ-5D-5L forms in English or Spanish, must be offered the opportunity to participate in the quality-of-life study\n* NOTE: As a part of the OPEN registration process, the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n* For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Gulf Health Hospitals Inc/Infirmary Cancer Care - 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Lanreotide, a type of somatostatin analog similar to somatostatin (a hormone made by the body), and is used to treat certain types of gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome.","whoItsFor":["Ages 18 Years to any","Participants must have histologically or radiographically confirmed diagnosis of pancreatic cancer or a pancreatic lesion with malignant potential","Participants must have an elective distal pancreatectomy planned to occur within 60 days after registration/randomization date","Participants must not have a known history of a prior diagnosis of malabsorption syndrome","Participants must not have been treated with any somatostatin analogue within 180 days prior to registration/randomization","Participants must not have been treated with radiation therapy for their pancreas malignancy at any time prior to registration/randomization","Participants must not have been treated with peptide receptor radionuclide therapy (PRRT) at any time prior to registration/randomization","Participants must be ≥ 18 years old"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Distal Pancreatectomy, or Lanreotide. The registry lists allocation as randomized. This phase III trial compares the effect of using lanreotide before surgery to surgery alone in preventing pancreatic fistulas in patients with pancreatic cancer or a pancreatic lesion that could become cancerous.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 274 people at 118 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.447Z"},{"nctId":"NCT06807619","title":"A Study of Sotorasib in People With Brain Tumors","officialTitle":"BrainMet ADePPT (Anticancer Drug Penetration Platform Trial)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.","conditions":["Brain Tumor"],"keywords":["SOTORASIB","KRAS G12C","CNS-BRAIN","Advanced","24-111"],"interventions":[{"type":"DRUG","name":"Sotorasib"}],"enrollment":16,"startDate":"2025-01-29","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy\n* Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy\n* For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60\n* Life expectancy \\>12 weeks\n* Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator\n* Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):\n\n  * Absolute neutrophil count (ANC) ≥1.0 × 10\\^3/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)\n  * Platelet count ≥10.0x10\\^4/μL. Note: Participants requiring ongoing transfusions or growth factor support to maintain platelet count ≥10.0x10\\^4/μL are not eligible. (Platelet transfusion is not allowed within 1 week prior to C1D1)\n  * Hemoglobin ≥ 7.0 g/dL (≥ 8 g/dL in gastric cancer / gastroesophageal cancer indications). Note: Participants requiring ongoing transfusions or growth factor support to maintain hemoglobin ≥8.0 g/dL are not eligible (Red blood cell transfusion is not allowed within 1 week prior to C1D1)\n  * Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault equation\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN) (\\<5x ULN in participants with liver metastases)\n  * Total bilirubin ≤1.5 × ULN) if no liver metastases or \\<3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to study treatment or any of the study drug excipients. For patients who are allergic to gadolinium-based agents may receive premedication as per institutional protocol or imaged without contrast at the discretion of the Principal Investigator; reactions will be managed per standard institutional protocol\n* Multiple primary malignancies within 3 years, with the exception of:\n\n  * adequately resected non-melanoma skin cancer\n  * carcinoma in situ of the cervix\n  * Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider\n  * curatively treated in-situ disease\n  * other solid tumors curatively treated\n  * for patients with metastatic breast cancer: contralateral breast cancer","locations":[{"facility":"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering West Harrison (Limited Protocol Activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nelson Moss, MD","phone":"212-639-7075","email":"mossn@mskcc.org"},{"name":"Cameron Brennan, MD","phone":"212-639-8268","email":""}],"primaryOutcomes":["ORR (overall response rate)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["sotorasib"],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york"],"enrichment":{"headline":"Phase 1: testing Sotorasib for Brain Tumor","inPlainEnglish":"The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.","whoItsFor":["Ages 18 Years to any","Adult patients ≥ 18 years of age with one or more brain tumors planned for neurosurgical resection/biopsy","Patients with concomitant leptomeningeal metastasis are eligible provided they have parenchymal brain neoplastic disease requiring resection/biopsy","For all cohorts: no limit on prior CNS radiation or systemic therapyKPS ≥ 60","Life expectancy \\>12 weeks","Adequate treatment washout period from prior therapies to allow recovery from any prior treatment-related toxicities before enrollment in the judgment of the Investigator","Adequate bone marrow, renal, hepatic, and coagulation parameters (obtained ≤7 days prior to the first day of study treatment):","Absolute neutrophil count (ANC) ≥1.0 × 10\\^3/μL (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1)"],"whoShouldSkip":["Multiple primary malignancies within 3 years, with the exception of:","adequately resected non-melanoma skin cancer","carcinoma in situ of the cervix","Smoldering pre-malignant or malignant conditions with minimal concern for CNS or extracranial progression during treatment such as CLL or MGUS based on the assessment of the treating provider","curatively treated in-situ disease","other solid tumors curatively treated","for patients with metastatic breast cancer: contralateral breast cancer"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib. The registry lists allocation as randomized. The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 16 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.971Z"},{"nctId":"NCT06810505","title":"A Study of Oral Atogepant Tablets to Assess Adverse Events and Change in Disease Activity To Prevent Migraine in Participants Aged 12 to 17 Years","officialTitle":"A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. The goals of the study are to evaluate adverse events and how well treatment of atogepant works compared to placebo (looks like the study treatment but contains no medicine) in preventing chronic migraine in participants between 12 and 17 years of age.\n\nAtogepant is a medicine currently approved in the United States and Europe for the preventive treatment of migraine in adult patients with migraine and is being studied for the preventative treatment of chronic migraine in participants between the ages of 12 and 17 years. Participants will be randomly assigned to one of the 2 groups to be treated with either atogepant or placebo. This study is double-blinded, which means that neither the patients nor the study doctors know who is given which study treatment. Approximately 420 participants 12 to 17 years of age with chronic migraine will be enrolled at approximately 70 sites across the world.\n\nParticipants will receive oral tablets of atogepant or placebo once daily for 12 weeks and will be followed for 4 weeks.\n\nParticipants will attend regular visits during the study at a hospital or clinic and the effects of treatment will be checked by completion of a daily diary, medical assessments, blood tests, checking for side effects, and completing questionnaires.","conditions":["Chronic Migraine"],"keywords":["Migraine","Chronic Migraine","Atogepant","QULIPTA","AQUIPTA"],"interventions":[{"type":"DRUG","name":"Atogepant"},{"type":"DRUG","name":"Placebo for Atogepant"}],"enrollment":420,"startDate":"2025-02-13","completionDate":"2031-03","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1.\n* During the last 28 days of the screening/baseline period, and as per eDiary:\n\n  * Participant must have completed the eDiary for a minimum of 20 out of 28 days.\n  * Participant has \\>= 15 headache days.\n  * Participant has \\>= 8 migraine days.\n\nExclusion Criteria:\n\n* Clinically significant hypertension per investigator's judgment.\n* History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease.","locations":[{"facility":"Rehabilitation and Neurological Services /ID# 270782","city":"Huntsville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Preferred Research Partners - Fayetteville /ID# 270419","city":"Fayetteville","state":"Arkansas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Preferred Research Partners /ID# 270389","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center /ID# 270257","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro Pain Research Center /ID# 271048","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance for Research Alliance for Wellness /ID# 270398","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research /ID# 270258","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lumos Clinical Research Center /ID# 270582","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research /ID# 270431","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Florida Clinical Research Group, LLC /ID# 270833","city":"Gulf Breeze","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Auzmer Research /ID# 271158","city":"Lakeland","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"My Preferred Research /ID# 270312","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research - Weston /ID# 271139","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pediatric Neurology & Epilepsy Center Of Central Florida - Winter Park /ID# 275263","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deaconess Midtown Hospital /ID# 270572","city":"Evansville","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Headache & Neurological Institute /ID# 270942","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proven Endpoints LLC /ID# 270269","city":"Ridgeland","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cct Research - Papillion Research Center /ID# 270393","city":"Papillion","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthy Perspectives - Innovate Mental Health Services /ID# 270847","city":"Nashua","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dent Neurologic Institute - Amherst /ID# 270260","city":"Amherst","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headache Wellness Center /ID# 270568","city":"Greensboro","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"The Children's Hospital of Philadelphia /ID# 270842","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research - Scottdale /ID# 270854","city":"Scottdale","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research - Smithfield /ID# 270849","city":"Smithfield","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Access Clinical Trials Inc /ID# 270280","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Health Austin at Dell Childrens Neurology Clinic /ID# 270577","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Earle Research /ID# 270424","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinpoint Trials /ID# 270261","city":"Waxahachie","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pantheon Clinical Research /ID# 270259","city":"Bountiful","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alpine Research Organization - Clinton /ID# 276527","city":"Clinton","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highland Clinical Research /ID# 270281","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research - Kingwood /ID# 271053","city":"Kingwood","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 270659","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre - Glen Site /ID# 270662","city":"Montreal","state":"Quebec","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Herlev Hospital /ID# 270482","city":"Herlev","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regionshospitalet Godstrup /ID# 270481","city":"Herning","state":"Central Jutland","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem /ID# 271219","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rozsavolgyi Rendelo-Ceba Bt. /ID# 271500","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 270756","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesu /ID# 270759","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Konan Medical Center /ID# 270486","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Umenotsuji Clinic /ID# 270484","city":"Kochi","state":"Kochi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tominaga Clinic - Osaka /ID# 270483","city":"Osaka","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Headache Clinic /ID# 271610","city":"Shibuya-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Medical University Hospital /ID# 270487","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tendo Brain Clinic /ID# 271410","city":"Tendo-shi","state":"Yamagata","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagaseki Headache Clinic /ID# 271699","city":"Kai","state":"Yamanashi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tanaka Neurosurgery & Headache Clinic /ID# 271346","city":"Kagoshima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Canisius-Wilhelmina Ziekenhuis /ID# 270374","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"HagaZiekenhuis /ID# 270379","city":"The Hague","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Center Medic-R /ID# 270235","city":"Poznan","state":"Greater Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Athleticomed Sp. z o.o /ID# 270243","city":"Bydgoszcz","state":"Kuyavian-Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specjalistyczne Gabinety Sp. z o.o /ID# 270238","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MIGRE Polskie Centrum Leczenia Migreny /ID# 270239","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oha-Med Sp. Z O.O /ID# 270242","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital da Luz /ID# 277991","city":"Lisbon","state":"Lisbon District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Almada-Seixal, EPE /ID# 278092","city":"Almada","state":"Setúbal District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Coimbra /ID# 277993","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Santa Maria /ID# 277997","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Santo Antonio /ID# 278090","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Caribbean Medical Research Center Headlands /ID# 271300","city":"San Juan","state":"","country":"Puerto Rico","status":"COMPLETED","lat":null,"lon":null},{"facility":"Great Ormond Street Children's Hospital /ID# 271550","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medway Maritime Hospital /ID# 271885","city":"Gillingham","state":"Kent","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Aberdeen Children's Hospital /ID# 271664","city":"Aberdeen","state":"Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leeds Teaching Hospitals NHS Trust /ID# 273449","city":"Leeds","state":"West Yorkshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stepping Hill Hospital-Stockport NHS foundation trust /ID# 271883","city":"Stockport","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Number of Participants Experiencing Adverse Events (AEs)","Change From Baseline in Mean Monthly Migraine Days"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["huntsville-alabama","fayetteville-arkansas","little-rock-arkansas","anaheim-california","fresno-california","long-beach-california","oceanside-california","san-jose-california","walnut-creek-california","gulf-breeze-florida","lakeland-florida","miami-florida","weston-florida","winter-park-florida","evansville-indiana","ann-arbor-michigan","ridgeland-mississippi","papillion-nebraska","nashua-new-hampshire","amherst-new-york","greensboro-north-carolina","philadelphia-pennsylvania","scottdale-pennsylvania","smithfield-pennsylvania","nashville-tennessee","austin-texas","houston-texas","waxahachie-texas","bountiful-utah","clinton-utah","salt-lake-city-utah","kingwood-west-virginia","london-canada","montreal-canada","herlev-denmark","herning-denmark","budapest-hungary","milan-italy","rome-italy","kobe-japan","kochi-japan","osaka-japan","shibuya-ku-japan","shinjuku-ku-japan","tendo-shi-japan","kai-japan","kagoshima-japan","nijmegen-netherlands","the-hague-netherlands","poznan-poland","bydgoszcz-poland","krakow-poland","wroclaw-poland","warsaw-poland","lisbon-portugal","almada-portugal","coimbra-portugal","porto-portugal","san-juan-puerto-rico","london-united-kingdom","gillingham-united-kingdom","aberdeen-united-kingdom","leeds-united-kingdom","stockport-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Atogepant for Chronic Migraine","inPlainEnglish":"Migraine is a disease that most often causes moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms.","whoItsFor":["Ages 12 Years to 17 Years","History of chronic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit 1","During the last 28 days of the screening/baseline period, and as per eDiary:","Participant must have completed the eDiary for a minimum of 20 out of 28 days","Participant has \\>= 15 headache days","Participant has \\>= 8 migraine days"],"whoShouldSkip":["Clinically significant hypertension per investigator's judgment","History of any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, cardiovascular or neurologic disease"],"whatHappens":"If you join, the listed intervention(s) are Atogepant, or Placebo for Atogepant. The registry lists allocation as randomized. Migraine is a disease that most often causes moderate to severe headache on one side of the head.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 420 people at 66 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.307Z"},{"nctId":"NCT06810518","title":"ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool","officialTitle":"ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"American Laboratory Products Company","sponsorClass":"INDUSTRY","summary":"The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.","conditions":["Inflammatory Bowel Disease (Crohn&#39;s Disease and Ulcerative Colitis)","Inflammatory Bowel Syndrome"],"keywords":["calprotectin","IBD","IBS"],"interventions":[{"type":"DEVICE","name":"ALPCO Calprotectin CLIA"}],"enrollment":1000,"startDate":"2025-03-25","completionDate":"2026-12-31","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria:\n\n* Male or female, ≥22 years of age (adults)\n* Subjects with suspected inflammatory bowel disease or irritable bowel syndrome presenting one or more of the following symptoms: abdominal pain, diarrhea, altered appetite, anemia, or unexpected weight loss. Not all symptoms are required; clinical presentation must support suspicion of inflammatory bowel disease or irritable bowel syndrome in the investigator's opinion.\n* Able to provide a sample either within 14 days before beginning bowel preparation for the scheduled colonoscopy, or between 3 and 14 days after the colonoscopy.\n* Able to understand the study and the tasks required and sign the ICF\n\nExclusion Criteria\n\n* Unable or unwilling to provide a stool specimen\n* Known active intestinal cancer or in remission with abnormal levels (per physician assessment)\n* Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)\n* Subjects receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period IBD patients who have previously diagnosed with IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA\n* IBD patients who have previously been diagnosed with IBD and have undergone surgical resection or diversion procedure.\n* Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment.\n* Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample.\n* Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection.\n* Samples are not collected according to sampling protocol.\n* Any condition that in the opinion of the investigator should preclude participation in the study.","locations":[{"facility":"Med-Care Research Corp","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ALPCO","city":"Salem","state":"New Hampshire","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gastro Intestinal Research Institute of Northern Ohio,","city":"Westlake","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yomi Ojutalayo","phone":"800-592-5726","email":"clinops@alpco.com"},{"name":"Jim Richard","phone":"800-592-5726","email":"regulatory@alpco.com"}],"primaryOutcomes":["In vitro diagnostic value of Calprotectin"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis","ibs"],"drugSlugs":[],"locationSlugs":["miami-florida","salem-new-hampshire","westlake-ohio"],"enrichment":{"headline":"Not a traditional drug phase: ALPCO Calprotectin CLIA for Inflammatory Bowel Disease (Crohn&#39;s Disease and Ulcerative Colitis)","inPlainEnglish":"The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation.","whoItsFor":["Ages 22 Years to any","Male or female, ≥22 years of age (adults)"],"whoShouldSkip":["Unable or unwilling to provide a stool specimen","Known active intestinal cancer or in remission with abnormal levels (per physician assessment)","Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)","IBD patients who have previously been diagnosed with IBD and have undergone surgical resection or diversion procedure","Current or active upper gastrointestinal disease (e.g., esophagitis, gastritis, GERD, or acid reflux) with ongoing symptoms or requiring active treatment","Use of proton pump inhibitors (PPIs) or H2-receptor antagonists within the 2 weeks prior to providing the stool sample","Use of NSAIDs, including aspirin, on seven or more days within the 14 days prior to sample collection"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.215Z"},{"nctId":"NCT06811116","title":"Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin, The SAPHIRE Trial","officialTitle":"A Phase I/II Trial of Sapanisertib in Combination With Cabozantinib in β-catenin-mutated Hepatocellular Carcinoma (SAPHIRE)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving sapanisertib and cabozantinib together may work better than giving cabozantinib alone in treating β-catenin-mutated metastatic hepatocellular carcinoma.","conditions":["Advanced Hepatocellular Carcinoma","Metastatic Hepatocellular Carcinoma","Stage III Hepatocellular Carcinoma AJCC v8","Stage IV Hepatocellular Carcinoma AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cabozantinib S-malate"},{"type":"PROCEDURE","name":"Imaging Procedure"},{"type":"DRUG","name":"Sapanisertib"}],"enrollment":92,"startDate":"2025-11-17","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach\n* For Phase 2, patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥ 2 cm) by chest x-ray or as ≥ 10 mm (≥ 1 cm) with CT scan, MRI, or calipers by clinical exam\n* For phase 2, patients must have a β-catenin mutation, based on next generation sequencing (NGS) testing through Clinical Laboratory Improvement Amendments (CLIA)-certified commercially available standard of care assay\n* Patients must have received at least one prior line of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible. For the phase 2 portion, patients must have received at least one and no more than two prior lines of systemic therapy in the metastatic setting, including a prior immune checkpoint inhibitor therapy unless not eligible\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of sapanisertib in combination with cabozantinib in patients \\<18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)\n* Child Pugh score of A\n* Absolute neutrophil count ≥ 1,000/mcL\n* Platelets ≥ 60,000/mcL\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 5 × institutional ULN\n* Glomerular filtration rate (eGFR) ≥ 40 mL/min/1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* For the phase 2 portion, availability of archival tumor tissue at the time of patient enrollment for banking for molecular profiling studies\n* The effects of sapanisertib and cabozantinib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Both men and women treated or enrolled on this protocol must agree to use adequate contraception prior to the study, for the duration of study participation, and for the following duration after completion of sapanisertib and cabozantinib administration:\n\n  * 90 days and 120 days after last dose of sapanisertib for women of childbearing potential and men respectively,\n  * 5 months and 7 months after last dose of cabozantinib for women of childbearing potential and men respectively\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to sapanisertib and cabozantinib\n* Use of strong CYP3A4-inhibiting agents due to drug-drug interaction with cabozantinib\n* Prior exposure to cabozantinib\n* Patients who are unable to swallow oral medications such as capsules and tablets and patients with gastrointestinal conditions that may affect the absorption of oral medications\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because sapanisertib and cabozantinib have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sapanisertib and cabozantinib, breastfeeding should be discontinued if the mother is treated with sapanisertib and cabozantinib","locations":[{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health/Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Dose-limiting toxicities and incidence of adverse events","Progression free survival (PFS)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["irvine-california","orange-california","portland-oregon","pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Cabozantinib S-malate for Advanced Hepatocellular Carcinoma","inPlainEnglish":"This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene. Sapanisertib and cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Patients must have histologically or cytologically confirmed HCC, not amenable to curative treatment approach","For phase 2, patients must have a β-catenin mutation, based on next generation sequencing (NGS) testing through Clinical Laboratory Improvement Amendments (CLIA)-certified commercially available standard of care assay","Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of sapanisertib in combination with cabozantinib in patients \\<18 years of age, children are excluded from this study","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)","Child Pugh score of A","Absolute neutrophil count ≥ 1,000/mcL","Platelets ≥ 60,000/mcL"],"whoShouldSkip":["Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia","Patients who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to sapanisertib and cabozantinib","Use of strong CYP3A4-inhibiting agents due to drug-drug interaction with cabozantinib","Prior exposure to cabozantinib","Patients who are unable to swallow oral medications such as capsules and tablets and patients with gastrointestinal conditions that may affect the absorption of oral medications","Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cabozantinib S-malate, or Imaging Procedure. The registry lists allocation as randomized. This phase I/II trial studies the side effects and best dose of sapanisertib when given together with cabozantinib, and to see how well they work in treating patients with liver cancer that has spread from where it first started to other places in the body (metastatic) and contains a mutation (change) in the β-catenin gene.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 92 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.636Z"},{"nctId":"NCT06811402","title":"Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients With Chronic Respiratory Disease: a Randomized Cross-over Trial","officialTitle":"Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients With Chronic Respiratory Disease: a Randomized Cross-over Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Fondation Hôpital Saint-Joseph","sponsorClass":"OTHER","summary":"Chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD), are a leading cause of death globally. These diseases not only contribute significantly to mortality but also lead to a decline in physical capacity, limiting daily activities and perpetuating a vicious cycle of deconditioning. Dyspnea (shortness of breath) is a major symptom, seen in 56 to 98% of COPD patients, and is linked to decreased exercise tolerance and muscle dysfunction. It often leads to reduced physical activity, further worsening respiratory function and quality of life. Dyspnea severity is associated with increased mortality, hospitalizations, and anxiety. The main therapeutic approach for these patients is pulmonary rehabilitation, which improves exercise tolerance, quality of life, and reduces hospitalizations and exacerbations. However, dyspnea limits exercise and is often a barrier to continued physical activity.\n\nVirtual reality (VR) technology has shown promise in managing symptoms like pain, anxiety, and dyspnea by providing a distraction. Studies suggest that VR can improve dyspnea and anxiety, particularly in patients hospitalized for conditions like COVID-19. However, research on VR's immediate effects on exercise capacity is limited, with most studies focusing on non-immersive exergames rather than immersive VR. The potential of VR to improve exercise tolerance in patients with chronic respiratory diseases remains uncertain. Our study aims to test this hypothesis through a randomized crossover trial to assess VR's impact on dyspnea and exercise tolerance in these patients.","conditions":["Chronic Obstructive Pulmonary Disease"],"keywords":[],"interventions":[{"type":"OTHER","name":"virtual reality"}],"enrollment":26,"startDate":"2026-10-14","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Patient with a chronic respiratory disease requiring pulmonary rehabilitation\n* Patient with dyspnea assessed as mMRC ≥ 0 (Annex 3)\n* Patient undergoing pulmonary rehabilitation at the Paris Saint-Joseph Hospital\n* Patient affiliated with a health insurance plan\n* French-speaking patient\n* Patient who has provided informed, explicit, and voluntary oral consent\n\nExclusion Criteria:\n\n* Contraindications for an endurance reconditioning program (neurodegenerative diseases, severe neurological deficits, unstable cardiovascular diseases)\n* History of motion sickness, vertigo, vestibular impairment, labyrinthitis\n* History of seizures or other neurological or psychiatric comorbidities\n* Severe visual impairments\n* Patient already included in a Type 1 interventional research protocol (RIPH1)\n* Patient under guardianship or curatorship\n* Patient deprived of liberty\n* Patient under legal protection\n* Pregnant or breastfeeding patient","locations":[{"facility":"Hôpital Paris Saint Joseph","city":"Paris","state":"Paris","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Johan Wormser","phone":"0144123085","email":"jwormser@ghpsj.fr"}],"primaryOutcomes":["Effort duration"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: virtual reality for Chronic Obstructive Pulmonary Disease","inPlainEnglish":"Chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD), are a leading cause of death globally. These diseases not only contribute significantly to mortality but also lead to a decline in physical capacity, limiting daily activities and perpetuating a vicious cycle of deconditioning.","whoItsFor":["Ages 18 Years to any","Patient aged 18 years or older","Patient with a chronic respiratory disease requiring pulmonary rehabilitation","Patient with dyspnea assessed as mMRC ≥ 0 (Annex 3)","Patient undergoing pulmonary rehabilitation at the Paris Saint-Joseph Hospital","Patient affiliated with a health insurance plan","French-speaking patient","Patient who has provided informed, explicit, and voluntary oral consent"],"whoShouldSkip":["Contraindications for an endurance reconditioning program (neurodegenerative diseases, severe neurological deficits, unstable cardiovascular diseases)","History of motion sickness, vertigo, vestibular impairment, labyrinthitis","History of seizures or other neurological or psychiatric comorbidities","Severe visual impairments","Patient already included in a Type 1 treatment research protocol (RIPH1)","Patient under guardianship or curatorship","Patient deprived of liberty"],"whatHappens":"If you join, the listed intervention(s) are virtual reality. The registry lists allocation as randomized. Chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD), are a leading cause of death globally.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 26 people at Paris. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.661Z"},{"nctId":"NCT06818019","title":"Withdrawal of Dupilumab in Severe Asthma","officialTitle":"WIthdrawal of DUpilumab in Severe Asthma: a Randomized Non-inferiority-controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Toulouse","sponsorClass":"OTHER","summary":"Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months. Although data showed that safety and efficacy of dupilumab are sustained when treatment is extended up to 3 years, no study has emerged regarding dupilumab discontinuation. This study aims to demonstrate the non-inferiority regarding strategy failure at 24 months of stopping dupilumab (intervention group) compared with its continuation (control group) in controlled asthma patients receiving this drug for at least 3 years.","conditions":["Severe Asthma"],"keywords":["severe asthma","dupilumab","exacerbation","discontinuation"],"interventions":[{"type":"DRUG","name":"Stopping dupilumab"}],"enrollment":205,"startDate":"2025-12-15","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients ≥ 18 years old\n* Treated with dupilumab for at least 36 months for severe asthma\n* Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit\n\nExclusion Criteria:\n\n* Patients who refuse to discontinue dupilumab, for any reason\n* Patients with Forced expiratory volume in one second ≤ 30% of predicted values\n* Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent)\n* Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma\n* Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis\n* Active smoking\n* Pregnancy or breastfeeding","locations":[{"facility":"CHU de Toulouse","city":"Toulouse","state":"CHU de Toulouse","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Amiens-Picardie","city":"Amiens","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHR d'Angers","city":"Angers","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CH de Bayonne","city":"Bayonne","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Besançon","city":"Besançon","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Brest","city":"Brest","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Caen","city":"Caen","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CH de Cannes","city":"Cannes","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Clermont-Ferrand","city":"Clermont-Ferrand","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHI de Créteil","city":"Créteil","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Dijon","city":"Dijon","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH Annecy Genevois","city":"Epagny-Metz-Annecy","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Grenoble-Alpes","city":"La Tronche","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Kremlin Bicêtre","city":"Le Kremlin-Bicêtre","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH Le Mans","city":"Le Mans","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Coeur Poumon, CHU de Lille","city":"Lille","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Croix Rousse","city":"Lyon","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Avicenne","city":"Paris","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Européen Georges Pompidou","city":"Paris","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Bichât","city":"Paris","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Bordeaux","city":"Pessac","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Lyon Sud","city":"Pierre-Bénite","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Reims","city":"Reims","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH de Roubaix","city":"Roubaix","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de La Réunion","city":"Saint-Denis","state":"France","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nantes","city":"Saint-Herblain","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nouvel Hôpital Civil","city":"Strasbourg","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Foch","city":"Suresnes","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Tarbes Lourdes","city":"Tarbes","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laurent GUILLEMINAULT, Md, PhD","phone":"0567771850","email":"guilleminault.l@chu-toulouse.fr"}],"primaryOutcomes":["Strategy failure"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["dupilumab"],"locationSlugs":["toulouse-france","amiens-france","angers-france","bayonne-france","besan-on-france","brest-france","caen-france","cannes-france","clermont-ferrand-france","cr-teil-france","dijon-france","epagny-metz-annecy-france","la-tronche-france","le-kremlin-bic-tre-france","le-mans-france","lille-france","lyon-france","paris-france","pessac-france","pierre-b-nite-france","reims-france","roubaix-france","saint-denis-france","saint-herblain-france","strasbourg-france","suresnes-france","tarbes-france"],"enrichment":{"headline":"Phase 4: testing Stopping dupilumab for Severe Asthma","inPlainEnglish":"Asthma management has been revolutionised by the development of biological therapies. Dupilumab is an anti-interleukin4 receptor marketed in 2020 for severe asthmatic patients with 2 exacerbations or more within the last 12 months.","whoItsFor":["Ages 18 Years to any","Adult patients ≥ 18 years old","Treated with dupilumab for at least 36 months for severe asthma","Well controlled asthma defined by an Asthma Control Questionnaire score ≥ 18 and 0 or 1 exacerbation within the year prior to the inclusion visit"],"whoShouldSkip":["Patients who refuse to discontinue dupilumab, for any reason","Patients with Forced expiratory volume in one second ≤ 30% of predicted values","Patients treated by an oral corticosteroid dose ≥ 10 mg/day (in prednisone equivalent)","Patients who have to discontinue dupilumab for a reason other than controlled asthma, such as an adverse drug reaction, a planned or current pregnancy, or a planned switch to another biologic indicated in severe asthma","Patients who have to continue dupilumab for the treatment of comorbidities apart from nasal polyposis","Pregnancy or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Stopping dupilumab. 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.707Z"},{"nctId":"NCT06818643","title":"A Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors (MK-3120-002)","officialTitle":"A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.","conditions":["Advanced Solid Tumors","Malignant Neoplasm"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-3120"}],"enrollment":270,"startDate":"2025-03-25","completionDate":"2028-02-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments\n* If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load\n* If hepatitis C virus (HCV) infected, must have undetectable HCV viral load\n\nExclusion Criteria:\n\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled significant cardiovascular disease or cerebrovascular disease\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage\n* Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Active infection requiring systemic therapy, with exceptions\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Has HBV or HCV infection","locations":[{"facility":"The University of Alabama at Birmingham ( Site 1005)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology ( Site 1010)","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology ( Site 1011)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology ( Site 1012)","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University ( Site 1008)","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Estudios Clínicos SAGA ( Site 0033)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fundación Arturo López Pérez ( Site 0031)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Catolica de Chile ( Site 0032)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital ( Site 0180)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Chongqing Cancer Hospital ( Site 0186)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital ( Site 0181)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University ( Site 0185)","city":"Changchun","state":"Jilin","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital Sichuan University ( Site 0187)","city":"Chengdu","state":"Sichuan","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli Calmettes ( Site 0053)","city":"Marseille","state":"Bouches-du-Rhone","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)","city":"Rennes","state":"Ille-et-Vilaine","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret ( Site 0051)","city":"Lille","state":"Nord","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy ( Site 0050)","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0082)","city":"Haifa","state":"","country":"Israel","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 0081)","city":"Petah Tikva","state":"","country":"Israel","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0080)","city":"Ramat Gan","state":"","country":"Israel","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East ( Site 0190)","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Institute Hospital of JFCR ( Site 0192)","city":"Koto","state":"Tokyo","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191)","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboudumc ( Site 0091)","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut - 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Mikoaja Kopernika w Koszalinie ( Site 0104)","city":"Koszalin","state":"West Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 0150)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital Yonsei University Health System ( Site 0151)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 0153)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center ( Site 0152)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia - L'Hospitalet ( Site 0113)","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)","city":"Barcelona","state":"Catalonia","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria ( Site 0114)","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chi Mei Medical Center ( Site 0162)","city":"Tainan","state":"Tainan","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital ( Site 0161)","city":"Tainan","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital ( Site 0160)","city":"Taipei","state":"","country":"Taiwan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent Şehir Hastanesi. ( Site 0131)","city":"Çankaya","state":"Ankara","country":"Turkey (Türkiye)","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ankara University Health Practice and Research Hospitals ( Site 0134)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri ( Site 0130)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koc University, School of Medicine ( Site 0133)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Number of Participants Who Experience an Adverse Event (AE)","Number of Participants Who Discontinue Study Treatment Due to an AE"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["birmingham-alabama","miami-florida","hackensack-new-jersey","austin-texas","houston-texas","irving-texas","richmond-virginia","santiago-chile","beijing-china","chongqing-china","changsha-china","changchun-china","chengdu-china","marseille-france","rennes-france","lille-france","villejuif-france","haifa-israel","petah-tikva-israel","ramat-gan-israel","kashiwa-japan","koto-japan","osaka-japan","nijmegen-netherlands","amsterdam-netherlands","rotterdam-netherlands","poznan-poland","krakow-poland","warsaw-poland","koszalin-poland","seoul-south-korea","lhospitalet-de-llobregat-spain","barcelona-spain","madrid-spain","m-laga-spain","tainan-taiwan","taipei-taiwan","ankaya-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Phase 1 / Phase 2: testing MK-3120 for Advanced Solid Tumors","inPlainEnglish":"Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery.","whoItsFor":["Ages 18 Years to any","Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments","If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)","If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load","If hepatitis C virus (HCV) infected, must have undetectable HCV viral load"],"whoShouldSkip":["Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease","Has uncontrolled significant cardiovascular disease or cerebrovascular disease","Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage","Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Known additional malignancy that is progressing or has required active treatment within the past 2 years","Known active central nervous system (CNS) metastases and/or carcinomatous meningitis"],"whatHappens":"If you join, the listed intervention(s) are MK-3120. The registry lists allocation as randomized. Researchers are looking for new ways to treat people with certain advanced solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 270 people at 49 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.106Z"},{"nctId":"NCT06819007","title":"Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","officialTitle":"A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01/ENGOT-ov89/GEICO144-O/GOG-3112/APGOT-OV13)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.","conditions":["Ovarian Cancer"],"keywords":["Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab"],"interventions":[{"type":"DRUG","name":"Trastuzumab Deruxtecan"},{"type":"DRUG","name":"Bevacizumab"}],"enrollment":582,"startDate":"2025-03-19","completionDate":"2028-11-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening informed consent form (ICF), prior to HER2 central testing. Sign and date the Main ICF prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube, or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV.\n5. Has HER2 expression.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion.\n4. Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable.\n5. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n6. Has a history of hemorrhagic disorders.","locations":[{"facility":"Disney Family Cancer Center","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scripps Clinic","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broward Health Medical Center","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jupiter Medical Center","city":"Jupiter","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Cancer 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Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guys Hospital Cancer Centre","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genesis Care, Beaumont House","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weston Park Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Contact for Trial Information","phone":"908-992-6400","email":"CTRinfo_us@daiichisankyo.com"}],"primaryOutcomes":["Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) in the HER2 IHC 3+/2+ Population"],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["burbank-california","la-jolla-california","palo-alto-california","fort-lauderdale-florida","jupiter-florida","miami-beach-florida","orlando-florida","st-petersburg-florida","savannah-georgia","evanston-illinois","indianapolis-indiana","shreveport-louisiana","towson-maryland","boston-massachusetts","ann-arbor-michigan","grand-rapids-michigan","minneapolis-minnesota","billings-montana","paramus-new-jersey","new-york-new-york","chapel-hill-north-carolina","centerville-ohio","portland-oregon","bethlehem-pennsylvania","lancaster-pennsylvania","sioux-falls-south-dakota","nashville-tennessee","salt-lake-city-utah","madison-wisconsin","adelaide-australia","auchenflower-australia","hobart-australia","perth-australia","richmond-australia","st-leonards-australia","sydney-australia","townsville-australia","innsbruck-austria","ghent-belgium","leuven-belgium","li-ge-belgium","namur-belgium","woluwe-saint-lambert-belgium","belo-horizonte-brazil","blumenau-brazil","ja-brazil","natal-brazil","porto-alegre-brazil","santo-andr-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","plovdiv-bulgaria","sofia-bulgaria","beijing-china","changchun-china","changsha-china","chengdu-china","chongqing-china","dalian-china","fuzhou-china","guangzhou-china","haikou-china","hangzhou-china","harbin-china","jinan-china","kunming-china","nanchang-china","nanjing-china","nanning-china","shanghai-china","shenyang-china","suzhou-china","taiyuan-china","tianjin-china","wuhan-china","xian-china","yantai-china","zhengzhou-china","ostrava-poruba-czechia","prague-czechia","aarhus-denmark","copenhagen-denmark","roskilde-denmark","bordeaux-france","dijon-france","lille-france","lyon-france","montpellier-france","nantes-france","paris-france","rennes-france","saint-etienne-france","berlin-germany","bonn-germany","detmold-germany","hamburg-germany","heilbronn-germany","jena-germany","mannheim-germany","marburg-germany","regensburg-germany","ulm-germany","wiesbaden-germany","athens-greece","neo-faliro-greece","thessaloniki-greece","budapest-hungary","debrecen-hungary","gy-r-hungary","ahmedabad-india","delhi-india","kolkata-india","mumbai-india","nagpur-india","nashik-india","pune-india","vadodara-india","varanasi-india","visakhapatnam-india","haifa-israel","jerusalem-israel","kfar-saba-israel","petah-tikva-israel","tel-aviv-israel","tel-hashomer-israel","bari-italy","bologna-italy","catania-italy","milan-italy","monza-italy","naples-italy","pisa-italy","ponderano-italy","reggio-emilia-italy","roma-italy","torino-italy","yahaba-cho-japan","akashi-japan","fukushima-japan","hidaka-japan","k-toku-japan","kurume-japan","nagoya-japan","nakatogari-japan","niigata-japan","okayama-japan","osaka-japan","sapporo-japan","tokyo-japan","tsu-japan","yamagata-japan","johor-bahru-malaysia","kuala-lumpur-malaysia","kuching-malaysia","putrajaya-malaysia","poznan-poland","siedlce-poland","bucharest-romania","oradea-romania","singapore-singapore","daegu-south-korea","goyang-si-south-korea","seongnam-si-south-korea","seoul-south-korea","a-coru-a-spain","barcelona-spain","c-rdoba-spain","donostia-san-sebastian-spain","el-palmar-spain","girona-spain","madrid-spain","palma-spain","pamplona-spain","san-blas-canillejas-spain","seville-spain","valencia-spain","lund-sweden","solna-sweden","uppsala-sweden","kaohsiung-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","cambridge-united-kingdom","london-united-kingdom","manchester-united-kingdom","oxford-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Trastuzumab Deruxtecan for Ovarian Cancer","inPlainEnglish":"This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.","whoItsFor":["Ages 18 Years to any","Women only","\\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures","Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old","Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube, or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous)","Is newly diagnosed International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV","Has HER2 expression"],"whoShouldSkip":["Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin","Has a known or suspected deleterious BRCA alteration as per local test that makes the participant eligible for poly (ADP-ribose) polymerase (PARP) inhibitor","Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion","Previous cerebral-vascular accident, transient ischemic attack or subarachnoid hemorrhage within 6 months prior to randomization","\\*Note: For participants enrolled from the Republic of Korea, country-specific requirements are applicable","Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy)","Has a history of hemorrhagic disorders"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab Deruxtecan, or Bevacizumab. The registry lists allocation as randomized. This clinical trial is designed to measure the how well it works and safety of T-DXd in combination with bevacizumab versus bevacizumab this drug alone as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+/2+/1+) advanced high-grade epithelial ovarian cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 582 people at 232 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.344Z"},{"nctId":"NCT06819176","title":"Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy","officialTitle":"Lenacapavir Intensification to Disrupt HIV Reservoirs in Virologically Suppressed People With HIV Receiving Antiretroviral Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nAntiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.\n\nObjective:\n\nTo test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.\n\nEligibility:\n\nPeople aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.\n\nDesign:\n\nParticipants will have 13 clinic visits over 2 years.\n\nParticipants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.\n\nParticipants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.\n\nTwo-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.\n\n...","conditions":["Human Immunodeficiency Virus"],"keywords":["HIV","ART intensification","Reservoir","lenacapavir","persistence"],"interventions":[{"type":"DRUG","name":"Lenacapavir"}],"enrollment":50,"startDate":"2026-01-20","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Able to provide informed consent.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Aged 18 years to 75 years.\n4. In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study.\n5. Confirmed HIV-1 infection.\n6. Total HIV DNA reservoir size greater than 300 copies/106 CD4+ T cells.\n7. CD4+ T cell count \\>200 cells/mm\\^3 at screening.\n8. Documentation of continuous ART treatment \\>3 years with suppression of plasma viral level below the limit of quantitation (\\<40 copies/mL). Individuals with \\<= 2 blips (\\>40 copies/mL) over 48 weeks prior to screening may be included provided they satisfy the following criteria:\n\n   1. The blips are \\<=200 copies/mL.\n   2. Succeeding viral levels return to below the limit of quantification (\\<40 copies/mL) on subsequent testing.\n9. For individuals who can become pregnant (ie, participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0. Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy.\n10. Participants who can become pregnant must agree to use 1 acceptable method of contraception when engaging in sexual activities that can result in pregnancy from 10 days prior to the first dose of lenacapavir through study follow up. Acceptable methods of contraception include the following:\n\n    1. Contraceptive subdermal implant.\n    2. Intrauterine device or intrauterine system.\n    3. Combined estrogen and progestogen oral contraceptive.\n    4. Injectable progestogen.\n    5. Contraceptive vaginal ring.\n    6. Percutaneous contraceptive patches.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History of AIDS-defining illness within 3 years prior to enrollment.\n2. History of systemic corticosteroids (eg, an equivalent dose of prednisone of \\>20 mg daily for \\>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy, lenacapavir, or other medications considered significant by the principal investigator within the last 6 months.\n3. Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation.\n4. Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood.\n\n   NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible.\n5. Pregnancy or lactation.\n6. Any licensed vaccine (eg, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to the study enrollment.\n7. Receipt of other investigational study agents within 28 days of enrollment and at any time during the study, including any experimental non-HIV vaccination within 2 weeks prior to enrollment.\n8. Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded:\n\n   1. Corticosteroid nasal spray or inhaler.\n   2. Topical corticosteroids for mild, uncomplicated dermatitis.\n   3. Oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy 10 days, with completion in 30 days prior to enrollment).\n   4. Cyclosporine eye drops\n9. Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.\n10. Laboratory abnormalities in the parameters listed below:\n\n    1. Absolute neutrophil count \\<1,000 cells/mm\\^3\n    2. Hemoglobin \\<10 g/dL\n    3. Platelet count \\<100,000 cells/mm\\^3\n    4. ALT \\>1.5 x ULN\n    5. AST \\>1.5 x ULN\n    6. Total bilirubin \\>1.5 x ULN\n    7. Estimated glomerular filtration rate \\<30 mL/min/1.73m\\^2\n11. Inability to undergo leukapheresis due to poor venous access or other medical conditions.\n12. Concurrent treatment with any of the medications listed below:\n\n    1. Antiarrhythmics: digoxin\n    2. Anticoagulants: direct oral anticoagulants (DOACs), rivaroxaban, dabigatran, edoxaban\n    3. Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin\n    4. Antiretroviral Agents: atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir\n    5. Antimycobacterials: Rifabutin, rifampin, rifapentine\n    6. Corticosteroids (systemic): dexamethasone, hydrocortisone/cortisone\n    7. Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine\n    8. Herbal products: St. John's wort c (Hypericum perforatum)\n    9. HMG-CoA reductase inhibitors: lovastatin simvastatin\n    10. Narcotic analgesics metabolized by CYP3A: fentanyl, oxycodone\n    11. Tramadol\n    12. Narcotic analgesic for treatment of opioid dependence: buprenorphine, methadone\n    13. Opioid antagonist: naloxegol\n    14. Phosphodiesterase-5 (PDE-5) inhibitors: sildenafil, tadalafil, vardenafil\n    15. Sedatives/Hypnotics: midazolam (oral), triazolam\n13. Past or current medical findings, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.\n\nCo-enrollment guidelines: Co-enrollment in other trials or protocols involving apheresis is restricted, other than enrollment on observational studies. Co-enrollment in an interventional trial will require the approval of the principal investigator. Study staff should be notified of co-enrollment on any other protocol as it may require the approval of the principal investigator.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathleen R Gittens","phone":"(301) 435-8003","email":"kathleen.gittens@nih.gov"},{"name":"Chuen-Yen C Lau, M.D.","phone":"(240) 858-7088","email":"lauc@mail.nih.gov"}],"primaryOutcomes":["Changes in the intact HIV proviral reservoir size, measured by IPDA in the blood CD4+ T-cell compartment from baseline to weeks 12, 24, 48, 72, and 96."],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Lenacapavir for Human Immunodeficiency Virus","inPlainEnglish":"Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives. HIV can remain in the body, in infected cells called reservoirs.","whoItsFor":["Ages 18 Years to 75 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availability for the duration of the study","Aged 18 years to 75 years","In generally good health with an identified primary health care provider for medical management of HIV infection and willing to maintain a relationship with a primary health care provider while participating in the study","Confirmed HIV-1 infection","Total HIV DNA reservoir size greater than 300 copies/106 CD4+ T cells","CD4+ T cell count \\>200 cells/mm\\^3 at screening"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","History of AIDS-defining illness within 3 years prior to enrollment","Any clinically significant acute or chronic medical condition (eg, autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation","Hepatitis B or C infection as indicated by the presence of hepatitis B surface antigen or hepatitis C virus (HCV) RNA in blood","NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible","Pregnancy or lactation","Any licensed vaccine (eg, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to the study enrollment"],"whatHappens":"If you join, the listed intervention(s) are Lenacapavir. The registry lists allocation as randomized. Background: Antiretroviral viral therapy (ART) allows people with human immunodeficiency (HIV) to live long, healthy lives.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.397Z"},{"nctId":"NCT06824467","title":"A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)","officialTitle":"A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan Maintenance Treatment With or Without Bevacizumab Versus Standard of Care After Second-line Platinum-based Doublet Chemotherapy in Participants With Platinum-sensitive Recurrent Ovarian Cancer (TroFuse-022/ENGOT-ov84/GOG-3103)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.","conditions":["Ovarian Cancer","Fallopian Tube Cancer","Primary Peritoneal Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"DRUG","name":"H1 receptor antagonist"},{"type":"DRUG","name":"H2 receptor antagonist"},{"type":"DRUG","name":"Acetaminophen (or equivalent)"},{"type":"DRUG","name":"Dexamethasone (or equivalent)"},{"type":"DRUG","name":"Steroid mouthwash (dexamethasone or equivalent)"}],"enrollment":770,"startDate":"2025-04-09","completionDate":"2029-04-27","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies\n* Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)\n* Has platinum-sensitive epithelial OC\n* Has provided tissue of a tumor lesion that was not previously irradiated\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)\n* Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Has an ECOG performance status of 0 or 1 assessed within 7 days before allocation (Part 1) or randomization (Part 2)\n\nExclusion Criteria:\n\n* Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors), low-grade serous tumors, low-grade endometrioid tumors, borderline tumors (low malignant potential), mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma\n* Has platinum-resistant OC or platinum-refractory OC\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has received more than 2 prior lines of systemic therapy for OC\n* Has received prior systemic anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter) before allocation (Part 1) or randomization (Part 2)\n* Has received prior radiotherapy within 2 weeks of allocation (Part 1) or randomization (Part 2), or has radiation related toxicities, requiring corticosteroids\n* Has an additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has active or ongoing stomatitis","locations":[{"facility":"University of Alabama at Birmingham ( Site 0006)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care ( Site 0096)","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center ( Site 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2807)","city":"Preston","state":"Lancashire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2801)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital (Sutton) ( Site 2802)","city":"Sutton","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham ( Site 2804)","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary ( Site 2808)","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clatterbridge Cancer Centre - Liverpool ( Site 2805)","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part 1: Number of Participants With One or More Adverse Events (AEs)","Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE","Part 2: Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","anchorage-alaska","duarte-california","irvine-california","san-francisco-california","walnut-creek-california","new-haven-connecticut","miami-beach-florida","sarasota-florida","west-palm-beach-florida","atlanta-georgia","augusta-georgia","fort-wayne-indiana","westwood-kansas","covington-louisiana","scarborough-maine","maplewood-minnesota","jackson-mississippi","st-louis-missouri","omaha-nebraska","hackensack-new-jersey","new-brunswick-new-jersey","albuquerque-new-mexico","mineola-new-york","new-york-new-york","pinehurst-north-carolina","cincinnati-ohio","columbus-ohio","tulsa-oklahoma","eugene-oregon","pittsburgh-pennsylvania","providence-rhode-island","nashville-tennessee","austin-texas","fort-worth-texas","san-antonio-texas","webster-texas","fairfax-virginia","milwaukee-wisconsin","ciudad-aut-noma-de-buenos-aires-argentina","mar-del-plata-argentina","buenos-aires-argentina","rosario-argentina","caba-argentina","c-rdoba-argentina","sydney-australia","brisbane-australia","east-melbourne-australia","frankston-australia","vienna-austria","graz-austria","innsbruck-austria","edegem-belgium","li-ge-belgium","ghent-belgium","leuven-belgium","namur-belgium","natal-brazil","porto-alegre-brazil","lages-brazil","s-o-jos-do-rio-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","calgary-canada","greater-sudbury-canada","mississauga-canada","toronto-canada","montreal-canada","port-montt-chile","santiago-chile","vi-a-del-mar-chile","bogot-colombia","pereira-colombia","brno-czechia","ostrava-poruba-czechia","prague-czechia","copenhagen-denmark","herlev-denmark","aalborg-denmark","vejle-denmark","oulu-finland","kuopio-finland","tampere-finland","lille-france","bordeaux-france","pierre-b-nite-france","caen-france","pl-rin-france","toulouse-france","chambray-l-s-tours-france","paris-france","saint-herblain-france","avignon-france","villejuif-france","athens-greece","cha-d-ri-greece","kecskem-t-hungary","szeged-hungary","debrecen-hungary","budapest-hungary","dublin-ireland","hadera-israel","haifa-israel","jerusalem-israel","kfar-saba-israel","ramat-gan-israel","aviano-italy","milan-italy","pisa-italy","bari-italy","brescia-italy","naples-italy","padova-italy","roma-italy","torino-italy","nagoya-japan","kashiwa-japan","matsuyama-japan","t-on-japan","kurume-japan","ta-japan","sapporo-japan","shiwa-gun-japan","hidaka-japan","sunto-gun-japan","koto-japan","shinjyuku-japan","fukuoka-japan","kagoshima-japan","niigata-japan","osaka-japan","guadalajara-mexico","mexico-city-mexico","monterrey-mexico","aguascalientes-mexico","cuauht-moc-mexico","oaxaca-city-mexico","castilla-peru","lima-peru","poznan-poland","warsaw-poland","bialystok-poland","szczecin-poland","kielce-poland","lisbon-portugal","porto-portugal","cluj-napoca-romania","craiova-romania","timi-oara-romania","bucharest-romania","goyang-si-south-korea","seodaemun-gu-south-korea","songpa-gu-south-korea","seoul-south-korea","girona-spain","madrid-spain","valencia-spain","barcelona-spain","c-rdoba-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkok-thailand","cambridge-united-kingdom","edinburgh-united-kingdom","preston-united-kingdom","london-united-kingdom","sutton-united-kingdom","birmingham-united-kingdom","leicester-united-kingdom","liverpool-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Sacituzumab tirumotecan for Ovarian Cancer","inPlainEnglish":"The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.","whoItsFor":["Ages 18 Years to any","Women only","Has locally advanced or metastatic, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma of certain histologies","Has received 4 or more cycles of platinum-based doublet chemotherapy in first-line and a total of 6 to 8 cycles of carboplatin-based doublet chemotherapy in second-line setting for ovarian cancer (OC)","Has platinum-sensitive epithelial OC","Has provided tissue of a tumor lesion that was not previously irradiated","Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy","Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation (Part 1) or randomization (Part 2)","Participants with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"],"whoShouldSkip":["Has platinum-resistant OC or platinum-refractory OC","Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis, or chronic diarrhea)","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease","Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected pneumonitis or ILD that cannot be ruled out by standard diagnostic assessments at Screening","HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has received more than 2 prior lines of systemic therapy for OC"],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Bevacizumab, or H1 receptor antagonist. The registry lists allocation as randomized. The main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 770 people at 202 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.155Z"},{"nctId":"NCT06824649","title":"Biologics in Chronic Rhinosinusitis With Nasal Polyposis","officialTitle":"SMART Use of Biologics in Chronic Rhinosinusitis With Nasal Polyposis","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Medical University of South Carolina","sponsorClass":"OTHER","summary":"The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure. The development of biologic medications over the last 5 years has revolutionized the treatment of CRSwNP. Three biologic medications have been FDA approved and available for the treatment of CRSwNP: dupilumab, omalizumab, and mepolizumab. However, data from the clinical trials for these drugs do not show universal improvement across all patients with CRSwNP. In fact, there is a wide range of outcomes for patients in these trials. The result is that clinicians have no way of knowing which specific biologic would be the best option for any given patient, nor do they know whether biomarkers can be used to predict response to biologics. It is hoped that findings from this study will inform whether any one biologic has superior outcomes to another and whether clinicians can identify patients at baseline who are most likely to improve on biologic therapy.","conditions":["Chronic Sinusitis","Nasal Polyps"],"keywords":["Sinusitis","Biologics"],"interventions":[{"type":"BIOLOGICAL","name":"Biologic Agents"}],"enrollment":504,"startDate":"2026-06-03","completionDate":"2030-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> 18 years\n* Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria\n* Bilateral nasal polyposis visible on sinonasal endoscopy\n* Nasal polyp score \\> 5\n* Baseline SNOT-22 total score \\> 30\n* Patient elects biologic therapy for the management of CRSwNP\n* Capable of receiving all 3 biologic therapy medications.\n* Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit.\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* Endoscopic sinus surgery within 6-months preceding enrollment / randomization.\n* Oral corticosteroid use within 30-days preceding enrollment / randomization.\n* Serum IgE level outside the dosing range for omalizumab (i.e., \\<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)\n* Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care.\n* Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization.\n* Any previous treatment with any of the 3 biologic medications.\n* Comorbid cystic fibrosis, CVID, or ciliary dyskinesia.\n* Comorbid systemic inflammatory disorders (e.g., GPA, EGPA, Sarcoidosis, SLE)\n* Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks for participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.","locations":[{"facility":"Mayo Clinic Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health ENT and Allergy - The Oaks","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Associate","phone":"(503) 494-5886","email":"ENTResearch@ohsu.edu"}],"primaryOutcomes":["Disease-Specific Quality of Life"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["dupilumab"],"locationSlugs":["phoenix-arizona","gainesville-florida","portland-oregon","charleston-south-carolina","nashville-tennessee"],"enrichment":{"headline":"Phase 4: testing Biologic Agents for Chronic Sinusitis","inPlainEnglish":"The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans. Until recently, the only medical treatment options available for patients with CRSwNP were corticosteroids, with surgery reserved for medical failure.","whoItsFor":["Ages 18 Years to any","Confirmed diagnosis of chronic rhinosinusitis with nasal polyposis using ICAR-21 (International Consensus Statement 20215) criteria","Bilateral nasal polyposis visible on sinonasal endoscopy","Nasal polyp score \\> 5","Baseline SNOT-22 total score \\> 30","Patient elects biologic therapy for the management of CRSwNP","Capable of receiving all 3 biologic therapy medications","Treatment with intranasal mometasone ≥200 μg. once daily (or equivalent of another intranasal corticosteroid) for 1-month prior to baseline visit"],"whoShouldSkip":["Endoscopic sinus surgery within 6-months preceding enrollment / randomization","Oral corticosteroid use within 30-days preceding enrollment / randomization","Serum IgE level outside the dosing range for omalizumab (i.e., \\<30 IU/ml. or a weight-based dose with insufficient data to determine dose as per FDA dosing chart)","Comorbid atopic dermatitis, urticaria, or any other condition that would require a specific biologic per the standard of care","Currently pregnant or plan to become pregnant within the 6 months after enrollment / randomization","Any previous treatment with any of the 3 biologic medications","Comorbid cystic fibrosis, CVID, or ciliary dyskinesia"],"whatHappens":"If you join, the listed intervention(s) are Biologic Agents. The registry lists allocation as randomized. The prevalence of Chronic Sinusitis with Nasal Polyps (CRSwNP) in the United States is estimated at roughly 4%, which equates to over 13 million Americans.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 504 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.699Z"},{"nctId":"NCT06826274","title":"Cervical tsDCS on Stroke Patients","officialTitle":"Clinical and Neurophysiological Evaluation of the Effects of Cervical tsDCS on Stroke Patients With Distal Upper Limb Strength Deficit","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"IRCCS San Raffaele Roma","sponsorClass":"OTHER","summary":"The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.","conditions":["Functional Recovery","Motor Rehabilitation"],"keywords":[],"interventions":[{"type":"OTHER","name":"tDCS"}],"enrollment":40,"startDate":"2026-03-15","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Group Stroke:\n\nInclusion criteria:\n\n1. age over 18 years;\n2. first ischemic/hemorrhagic stroke (within 30 days of onset);\n3. mild-to-moderate stroke (NIHSS scale score\\<16).\n4. residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;\n5. ability to give informed consent and understand instructions.\n\nExclusion criteria:\n\n1. severe spasticity (Ashworth Scale score \\> 2);\n2. severe aphasia;\n3. severe neglect;\n4. history of disabling neurological disease;\n5. history of epilepsy;\n6. significant comorbidities;\n7. contraindications to tsDCS.\n\nHealthy Group:\n\nInclusion criteria:\n\n1. age over 18 years;\n2. equalized in age with the patient group.\n\nExclusion criteria:\n\n1. history of stroke progress;\n2. history of severe neurological disease.","locations":[{"facility":"IRCCS San Raffaele Roma","city":"Roma","state":"RM","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS San Raffaele Roma","city":"Rome","state":"Rome","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fabrizio Vecchio","phone":"3478031201","email":"fabrizio.vecchio@sanraffaele.it"}],"primaryOutcomes":["improvement of paretic hand performance","improvement of paretic hand performance","improvement of paretic hand performance","improvement of paretic hand performance","improvement of paretic hand performance"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["roma-italy","rome-italy"],"enrichment":{"headline":"Not a traditional drug phase: tDCS for Functional Recovery","inPlainEnglish":"The present project aims to measure the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.","whoItsFor":["Ages 18 Years to any","first ischemic/hemorrhagic stroke (within 30 days of onset);","mild-to-moderate stroke (NIHSS scale score\\<16)","residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;"],"whoShouldSkip":["severe spasticity (Ashworth Scale score \\> 2);","history of disabling neurological disease;","history of epilepsy;","significant comorbidities;","contraindications to tsDCS","who can join:","equalized in age with the patient group"],"whatHappens":"If you join, the listed intervention(s) are tDCS. The registry lists allocation as randomized. The present project aims to measure the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.225Z"},{"nctId":"NCT06827236","title":"A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer","officialTitle":"A Phase I/II, Multi-site, Open-label, Two-part Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of BNT323 in Combination With BNT327 in Participants With Advanced Breast Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"BioNTech SE","sponsorClass":"INDUSTRY","summary":"This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).","conditions":["Locally Advanced Breast Cancer","Unresectable Breast Carcinoma","Metastatic Breast Cancer"],"keywords":["Breast Cancer (BC)","Human epidermal growth factor receptor 2 (HER2)","IHC scores 0, 1+, 2+, and 3+","Antibody drug conjugate (ADC)","Programmed Death-1 (PD-1)","Programmed Death Ligand-1 (PD-L1)","Programmed Death-1 monoclonal antibodies","Anti vascular endothelial growth factor-A (anti-VEGF-A)"],"interventions":[{"type":"DRUG","name":"BNT323"},{"type":"DRUG","name":"BNT327"}],"enrollment":380,"startDate":"2025-04-23","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria (applicable to all participants and all parts unless otherwise specified):\n\n* Have pathologically documented BC that:\n\n  * Is locally advanced, unresectable or metastatic.\n  * Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample.\n  * Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines.\n* Have measurable disease defined by RECIST v1.1.\n* Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment.\n\nKey Exclusion Criteria:\n\n* Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.\n* Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.\n* Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.\n* Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.\n* Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan.\n* Have received any of the following therapies or drugs prior to the initiation of the study:\n\n  * Participants who have received prior treatment with BNT323.\n  * Participants who received prior treatment with a programmed death-ligand 1 (PD-L1) / vascular endothelial growth factor (VEGF) bispecific antibody. Note: Prior treatment with programmed death 1 (PD-1)/VEGF bispecific antibodies, PD-1/PD-L1 inhibitors or anti-VEGF therapies are permitted.\n  * Have received other systemic immunostimulatory agents or immunosuppressive therapies (such as interferon-α, interleukin-2, or methotrexate) within 4 weeks prior to the initiation of study treatment or are within five half-lives of the treatment drug (whichever is longer). Exception: excluding local, intranasal, intraocular, intra-articular or inhaled corticosteroids, short term use (≤7 days) of corticosteroids for prophylaxis (e.g., prevention of contrast agent allergy) or treatment of non-autoimmune conditions (e.g., delayed hypersensitivity reactions caused by exposure to allergens).\n  * Have received systemic corticosteroids (at a dosage greater than 10 mg/day of prednisone or an equivalent dose of other corticosteroids) within 3 weeks prior to the initiation of study treatment.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Beverly Hills Cancer Center","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology - Oncology Associates of the Treasure 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Occurrence of dose limiting toxicities (DLTs)","Occurrence of Treatment-emergent adverse events (TEAEs), Grade ≥3 TEAEs, serious adverse events (SAEs), treatment-related TEAEs, treatment-related Grade ≥3 TEAEs, and treatment-related SAEs","Occurrence of dose interruption, reduction, and discontinuation due to TEAEs","Part 2 - Objective response rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["beverly-hills-california","newport-beach-california","port-saint-lucie-florida","athens-georgia","atlanta-georgia","chicago-illinois","detroit-michigan","grand-rapids-michigan","kansas-city-missouri","st-louis-missouri","basking-ridge-new-jersey","florham-park-new-jersey","middletown-new-jersey","montvale-new-jersey","harrison-new-york","new-york-new-york","stony-brook-new-york","uniondale-new-york","nashville-tennessee","dallas-texas","san-antonio-texas","madison-wisconsin","adelaide-australia","box-hill-australia","fitzroy-australia","melbourne-australia","chicoutimi-canada","london-canada","toronto-canada","vancouver-canada","bengbu-china","changchun-china","chengdu-china","chongqing-china","huizhou-china","nanning-china","shanghai-china","xian-china","besan-on-france","le-mans-france","saint-herblain-france","toulouse-france","tbilisi-georgia","bologna-italy","genova-italy","milan-italy","naples-italy","roma-italy","chisinau-moldova","barcelona-spain","madrid-spain","pamplona-spain","pozuelo-de-alarc-n-spain","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","konya-turkey-t-rkiye","mersin-turkey-t-rkiye","cambridge-united-kingdom","cardiff-united-kingdom","leeds-united-kingdom","london-united-kingdom","manchester-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing BNT323 for Locally Advanced Breast Cancer","inPlainEnglish":"This is a Phase I/II, multi-site, open-label, two-part study designed to measure the how well it works, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).","whoItsFor":["Ages 18 Years to any","Key (applicable to all participants and all parts unless otherwise specified):","Have pathologically documented BC that:","Is locally advanced, unresectable or metastatic","Has a confirmed HER2 status as determined by the local laboratory as standard of care testing prior to study screening (Part 1, Part 2 Cohorts 2 and 4) or the central laboratory (Part 2, Cohorts 1 and 3) from the most recently collected pre-randomization tumor sample","Has a documented history of HER2 expression consistent with the subgroup definitions (i.e., HER2-low, HER2-ultralow, HER2-null, HER2-positive, or TNBC) as per current American Society of Clinical Oncology/College of American Pathologists guidelines","Have measurable disease defined by RECIST v1.1","Has left ventricular ejection fraction ≥55% by either echocardiography or multi-gated acquisition (scanning) within 28 days before randomization/enrollment"],"whoShouldSkip":["Have history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP","Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring side effects","Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment","Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening","Had prior treatment with topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads such as trastuzumab deruxtecan","Have received any of the following therapies or drugs prior to the initiation of the study:","Participants who have received prior treatment with BNT323"],"whatHappens":"If you join, the listed intervention(s) are BNT323, or BNT327. The registry lists allocation as randomized. This is a Phase I/II, multi-site, open-label, two-part study designed to measure the how well it works, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hormone receptor-positive (HR+) or hormone receptor-negative (HR-), Human epidermal growth factor receptor (HER)2-positive, HER2-low (immunohistochemistry \\[IHC\\] 1+ or IHC 2+/in situ hybridization -), HER2-ultralow (IHC 0, with membrane staining) or HER2-null breast cancer (BC), or triple-negative breast cancer (TNBC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 380 people at 84 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.952Z"},{"nctId":"NCT06835504","title":"Morphine or Ketamine for Analgesia","officialTitle":"Efficacy of Intravenous Sub-Dissociative Ketamine Versus Intravenous Morphine in Children With Acute Pain","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Columbia University","sponsorClass":"OTHER","summary":"Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration. The investigators aim to determine if sub-dissociative ketamine is non-inferior to morphine for treating acute pain and a preferable alternative for treating acute pain in children because of its more favorable side effect profile and potential long-term benefits related to pain-related function, analgesic use/misuse, and mental and behavioral health outcomes.","conditions":["Abdominal Pain","Isolated Extremity Fracture","Pain","Pediatrics"],"keywords":["Ketamine","Morphine","Pediatric","Children","Sub-dissociative","Opioid-sparing","Emergency medicine","Emergency care","Emergency department","Post-traumatic stress","Anxiety","Depression","Abdominal pain","Fracture","Analgesia"],"interventions":[{"type":"DRUG","name":"Ketamine hydrochloride"},{"type":"DRUG","name":"Morphine sulphate"}],"enrollment":1010,"startDate":"2026-10-17","completionDate":"2030-04-23","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 6 to \\< 18 years old\n2. Chief complaint includes abdominal pain OR isolated long-bone extremity fracture (suspected or proven)\n3. Self-reported pain score of ≥ 6/10\n4. Requires IV morphine for analgesia as determined by the treating physician\n\nExclusion Criteria:\n\n1. Weighs more than 81.9 kg\n2. Known allergy/contraindication to morphine or ketamine\n3. Antecedent receipt of ketamine related to presenting complaint\n4. Inability to use self-report measures of pain or questionnaires\n5. Chronic disease associated with pain\n6. Chronic pain conditions requiring use of opioids as an outpatient\n7. Abnormal vital signs at baseline, defined as oxygen saturation \\<92% and/or low respiratory rate and/or low heart rate and/or low blood pressure per age\n8. Altered mental state (e.g., GCS \\< 14 or clinical intoxication)\n9. Known history of schizophrenia, liver or kidney problems, or osteogenesis imperfecta\n10. Concern for open fracture, neurovascular compromise, or compartment syndrome\n11. Injuries in addition to the extremity injury (e.g., head, neck, abdomen)\n12. Known or reported pregnancy\n13. Patients who are breastfeeding\n14. Patient or parent/guardian does not speak English or Spanish\n15. Patient previously enrolled in this study\n16. Known significant or uncontrolled cardiovascular disease\n17. Known increased intracranial pressure and/or elevated intraocular pressure\n18. Currently taking or having used a monoamine oxidase inhibitor within 14 days\n19. Wards of state, foster children, or children in custody","locations":[{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UC Davis Children's Hospital","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nemours Children's Hospital","city":"Wilmington","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur M. Blank Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NewYork Presbyterian Morgan Stanley Children's Hospital","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UPMC Children's Hospital of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel S Tsze, MD, MPH","phone":"917-375-2647","email":"dst2141@cumc.columbia.edu"},{"name":"Amy L Drendel, DO, MS","phone":"","email":"adrendel@mcw.edu"}],"primaryOutcomes":["Pain intensity","Cardiopulmonary adverse events requiring an intervention","Pain-related function","Post-traumatic stress"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["los-angeles-california","sacramento-california","wilmington-delaware","atlanta-georgia","new-york-new-york","pittsburgh-pennsylvania","seattle-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 3: testing Ketamine hydrochloride for Abdominal Pain","inPlainEnglish":"Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences. Morphine is the standard treatment for children with moderate to severe acute pain, but its use is associated with serious side effects and caregiver and clinician concerns related to opioid administration.","whoItsFor":["Ages 6 Years to 17 Years","Age 6 to \\< 18 years old","Chief complaint includes abdominal pain OR isolated long-bone extremity fracture (suspected or proven)","Self-reported pain score of ≥ 6/10","Requires IV morphine for analgesia as determined by the treating physician"],"whoShouldSkip":["Weighs more than 81.9 kg","Known allergy/contraindication to morphine or ketamine","Antecedent receipt of ketamine related to presenting complaint","Inability to use self-report measures of pain or questionnaires","Chronic disease associated with pain","Chronic pain conditions requiring use of opioids as an outpatient","Abnormal vital signs at baseline, defined as oxygen saturation \\<92% and/or low respiratory rate and/or low heart rate and/or low blood pressure per age"],"whatHappens":"If you join, the listed intervention(s) are Ketamine hydrochloride, or Morphine sulphate. The registry lists allocation as randomized. Pain is common in children presenting to the emergency department but is frequently undertreated, leading to both short- and long-term consequences.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,010 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.415Z"},{"nctId":"NCT06839950","title":"Sensory Profile and Early Clinical Signs of Calm Room Users","officialTitle":"Sensory Profile and Early Clinical Signs of Calm Room Users","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre Hospitalier Esquirol","sponsorClass":"OTHER","summary":"This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room.\n\nThe main questions it aims to answer are :\n\n* Could sensory information processing disorders be the cause of distress and tension in these patients?\n* Could users of the calming room present extreme sensory processing profiles, characterized by either hypersensitivity or hyposensitivity ?\n\nParticipants will answer a survey to determine their the sensory profile. Participants can already use the calming room as part of their regular medical care and they will answer surveys before and after each use.","conditions":["Psychotic Disorders","Personality Disorders","Mood Disorders"],"keywords":["Calm room","Psychotic Disorders","Sensory Profile","Mood Disorders","Personality Disorders"],"interventions":[{"type":"OTHER","name":"Calm room"}],"enrollment":80,"startDate":"2023-12-19","completionDate":"2027-12-19","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Gender and Age: Male or female, aged 18 to 65\n* Hospitalization: Admitted to the closed hospitalization unit for less than 10 days\n* Social security: Affiliated or beneficiary of a social security system\n* Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination).\n\nExclusion Criteria:\n\n* Inability to understand information related to the study\n* Proven sensory disability\n* Dementia\n* Pregnancy\n* Lack of social protection\n* Previous Participation in this research protocol (in the case of a new hospitalization)\n* Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)","locations":[{"facility":"Esquirol Hsopital Center","city":"Limoges","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aude Paquet, PhD in Psychology","phone":"+33 5-55-43-11-27","email":"aude.paquet@ch-esquirol-limoges.fr"}],"primaryOutcomes":["Scores of Sensory Sensitivity from the Adolescent/Adult Sensory Profile (Brown and Dunn, 2002) for users of the calming room and non-users of the calming room"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["limoges-france"],"enrichment":{"headline":"Not a traditional drug phase: Calm room for Psychotic Disorders","inPlainEnglish":"This descriptive study aims primarily to characterize the sensory profile of patients in a closed psychiatric hospital unit who use a calming room. The main questions it aims to answer are : * Could sensory information processing disorders be the cause of distress and tension in these patients?","whoItsFor":["Ages 18 Years to 65 Years","Gender and Age: Male or female, aged 18 to 65","Hospitalization: Admitted to the closed hospitalization unit for less than 10 days","Social security: Affiliated or beneficiary of a social security system","Consent: Free, informed, and written consent, signed by the participant and/or their legal representative (for participants under protection measures) and the investigator (at the latest on the day of inclusion and before any research-related examination)"],"whoShouldSkip":["Inability to understand information related to the study","Proven sensory disability","Lack of social protection","Previous Participation in this research protocol (in the case of a new hospitalization)","Expression abilities incompatible with completing the AASP Scale (e.g., french language comprehension issues, mute individuals, patients in restraint and/or therapeutic isolation)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Limoges. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.043Z"},{"nctId":"NCT06840782","title":"First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients.","officialTitle":"First-line Immunotherapy-based Standard of Care and Local Ablative Treatments for Oligometastatic Non-small Cell Lung Cancer Patients: a Randomized, Multicentre, Open-label Phase III Study","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","sponsorClass":"OTHER","summary":"First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomized, multicentre, open-label phase III study","conditions":["Oligometastatic Non-small Cell Lung Cancer (NSCLC)"],"keywords":["Local ablative treatments","First-line immunotherapy","SBRT","Interventional radiology","Minimally invasive surgery"],"interventions":[{"type":"RADIATION","name":"Radical local treatment"},{"type":"DRUG","name":"SoC-based immunotherapy (+/- chemotherapy)"}],"enrollment":124,"startDate":"2025-09-09","completionDate":"2030-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically proven advanced synchronous oligometastatic stage IV NSCLC.\n* NSCLC patients eligible first line immunotherapy-based SoC according to the European Marketing Authorization.\n* PDL1 status available.\n* Metastases eligible to RLT according to the local multidisciplinary board (MTB): ≤5cm each in CT scan, excluding primary tumour.\n* Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and FDG-PET.\n* Symptomatic lesions requiring urgent palliative radiation, is permitted prior to randomization. These treated lesions should be counted towards the total number of metastases at the time of enrolment.\n* Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is permitted and BM count within the total number of 5 lesions. The patient would then be randomized to treatment of their extracranial disease.\n* Acceptable organ function for RLT.\n* ECOG performance status (PS) 0-1.\n* Measurable lesions according to RECIST V1.1 on standard imaging.\n* Patient aged 18 or more.\n* Woman of childbearing potential must agree to use adequate contraception (implant type, vaginal ring, contraceptive pill, contraceptive patch, Intrauterine Device (IUD), etc.) for the duration of study participation and up to 6 months after completing treatment/therapy, in addition, male partners use a condom during this same period. Male patients must agree to use condom for the duration of study participation and up to 6 months after completing treatment/therapy.\n* Patients affiliated to the social security system.\n* Patient should understand, sign, and date the informed consent form written in French prior to any protocol-specific procedures performed.\n* Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits, and examinations including follow-up.\n\nExclusion Criteria:\n\n* Non-squamous NSCLC with targetable tumour mutations and approved first line targeted therapy (such as EGFR, ALK and ROS1).\n* Metastases not eligible to RLT: e.g. brainstem or diffuse serosal metastases (meningeal, pericardial, pleural, peritoneal, mesenteric) or that invades the gastrointestinal tract.\n* Brain metastases only, without extra-cerebral metastases.\n* Uncontrolled severe comorbidity, symptomatic interstitial lung disease or active infection.\n* Prior therapy with T-cell costimulation or immune checkpoint-targeted agents within 1 year.\n* Uncontrolled concomitant (\\<1-year) malignancy except adequately treated basal or squamous cell carcinoma of the skin, or in-situ carcinoma of any organ or in-situ melanoma of the skin.\n* Persons deprived of liberty by judicial or administrative decision.\n* Persons subject to a legal protection measure (guardianship, curatorship, safeguard of justice).\n* Persons not affiliated to a social security system or equivalent.","locations":[{"facility":"Institut de Radiothérapie du Sud de l'Oise","city":"Creil","state":"Hauts-de-France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Sainte-Catherine","city":"Avignon","state":"Provence-Alpes-Côte d'Azur Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre François Baclesse","city":"Caen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospices Civils de Lyon (HCL)","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Nice","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancérologie du Gard","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Paris Saint- Joseph","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Polyclinique Ormeau","city":"Tarbes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Saint-Cloud","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Antonin LEVY","phone":"01 42 11 47 57","email":"antonin.levy@gustaveroussy.fr"}],"primaryOutcomes":["Overall Survival (OS)."],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["creil-france","avignon-france","caen-france","lille-france","lyon-france","nice-france","n-mes-france","paris-france","tarbes-france","saint-cloud-france","villejuif-france"],"enrichment":{"headline":"Phase 3: testing SoC-based immunotherapy (+/- chemotherapy) for Oligometastatic Non-small Cell Lung Cancer (NSCLC)","inPlainEnglish":"First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomly assigned, multicentre, open-label phase III study","whoItsFor":["Ages 18 Years to any","Histologically proven advanced synchronous oligometastatic stage IV NSCLC","NSCLC patients eligible first line immunotherapy-based SoC according to the European Marketing Authorization","PDL1 status available","Metastases eligible to RLT according to the local multidisciplinary board (MTB): ≤5cm each in CT scan, excluding primary tumour","Maximum 5 metastases in 3 organs (EORTC criteria), according to brain MRI and FDG-PET","Symptomatic lesions requiring urgent palliative radiation, is permitted prior to randomization. These treated lesions should be counted towards the total number of metastases at the time of enrolment","Clinically required brain metastases (BM) ablation (surgery and/or SBRT) is permitted and BM count within the total number of 5 lesions. The patient would then be randomly assigned to treatment of their extracranial disease"],"whoShouldSkip":["Non-squamous NSCLC with targetable tumour mutations and approved first line targeted therapy (such as EGFR, ALK and ROS1)","Metastases not eligible to RLT: e.g. brainstem or diffuse serosal metastases (meningeal, pericardial, pleural, peritoneal, mesenteric) or that invades the gastrointestinal tract","Brain metastases only, without extra-cerebral metastases","Uncontrolled severe comorbidity, symptomatic interstitial lung disease or active infection","Prior therapy with T-cell costimulation or immune checkpoint-targeted agents within 1 year","Uncontrolled concomitant (\\<1-year) malignancy except adequately treated basal or squamous cell carcinoma of the skin, or in-situ carcinoma of any organ or in-situ melanoma of the skin","Persons deprived of liberty by judicial or administrative decision"],"whatHappens":"If you join, the listed intervention(s) are Radical local treatment, or SoC-based immunotherapy (+/- chemotherapy). The registry lists allocation as randomized. First-line immunotherapy-based standard of care and local ablative treatments for oligometastatic non-small cell lung cancer patients: a randomly assigned, multicentre, open-label phase III study","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 124 people at 11 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.001Z"},{"nctId":"NCT06841354","title":"A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)","officialTitle":"A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as a Monotherapy and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less Than 10 (TroFuse-011)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.","conditions":["Triple Negative Breast Neoplasms"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Antibody-drug conjugate (ADC)","Trophoblast cell-surface antigen 2 (TROP2)"],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Rescue Medication"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Nab-paclitaxel"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Carboplatin"}],"enrollment":1000,"startDate":"2025-03-16","completionDate":"2030-05-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent\n* Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer\n* Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence\n* Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10\n* Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer\n* Has Grade ≥2 peripheral neuropathy\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has skin only metastatic disease\n* Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable\n* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection\n* History of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","locations":[{"facility":"USA Mitchell Cancer Institute ( Site 0090)","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers ( Site 0036)","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope ( Site 0097)","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Lennar Foundation Cancer Center ( Site 0099)","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Department of Medicine - Hematology & Oncology ( Site 0047)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale New Haven Hospital ( Site 0001)","city":"New Haven","state":"Connecticut","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Washington Hospital Center ( Site 0098)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007)","city":"Altamonte Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute ( Site 0012)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - East ( Site 7000)","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Cancer & Blood Center, LLC ( Site 0023)","city":"Athens","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's Cancer Institute: Boise ( Site 0037)","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Cancer Center ( Site 0044)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Franklin Square Medical Center ( Site 0031)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Good Samaritan Hospital ( Site 0079)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Southern Maryland Hospital Center ( Site 0100)","city":"Clinton","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Montgomery Medical Center ( Site 0078)","city":"Olney","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital ( Site 0091)","city":"Silver Spring","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer & Hematology Centers of Western Michigan ( Site 0026)","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allina Health Cancer Institute ( Site 0069)","city":"Minneapolis","state":"Minnesota","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hattiesburg Clinic Hematology/Oncology ( Site 0104)","city":"Hattiesburg","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Comprehensive Cancer Centers of Nevada ( Site 0015)","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center ( Site 0005)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Mexico Oncology Hematology Consultants Ltd. ( Site 0019)","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073)","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laura and Isaac Perlmutter Cancer Center ( Site 0003)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rex Hematology Oncology Associates - Garner ( Site 0071)","city":"Garner","state":"North Carolina","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 7004)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology ( Site 0018)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - 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Hospital de Cancer de Barretos ( Site 2307)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 2301)","city":"São Jose Do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"IBCC - Núcleo de Pesquisa e Ensino ( Site 2306)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cross Cancer Institute ( Site 0216)","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lakeridge Health ( Site 0217)","city":"Oshawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"North York General Hospital ( Site 0209)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0202)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIUSSS- saguenay-Lac-Saint-Jean ( Site 0213)","city":"Chicoutimi","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 0208)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital ( Site 0203)","city":"Montreal","state":"Quebec","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"St. Marys Hospital Center ( Site 0201)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre ( Site 0204)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Du Saint-Sacrement ( Site 0210)","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saskatoon Cancer Centre ( Site 0215)","city":"Saskatoon","state":"Saskatchewan","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocenter ( Site 2009)","city":"Concepción","state":"Biobio","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"IC La Serena Research ( Site 2007)","city":"La Serena","state":"Coquimbo Region","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Arturo López Pérez ( Site 2000)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica UC San Carlos de Apoquindo ( Site 2008)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill ( Site 2001)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"ONCOCENTRO APYS ( Site 2005)","city":"Viña del Mar","state":"Valparaiso","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Afflilated Hospital of Bengbu Medical College ( Site 5022)","city":"Bengbu","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University ( Site 5039)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Three Gorges Hospital ( Site 5020)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"The First Affiliated hospital of Xiamen University ( Site 5035)","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center ( Site 5014)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangxi Medical University Affiliated Tumor Hospital. ( Site 5008)","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital ( Site 5001)","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tongji Hospital Tongji Medical Science & Technology ( Site 5007)","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiangyang Central Hospital ( Site 5017)","city":"Xiangyang","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital ( Site 5002)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital ( Site 5009)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xuzhou Central Hospital ( Site 5036)","city":"Xuzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jilin Province Tumor Hospital ( Site 5040)","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University ( Site 5003)","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi an Jiaotong University ( Site 5005)","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital ( Site 5031)","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"LinYi Cancer Hospital ( Site 5021)","city":"Linyi","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Cancer Hospital ( Site 5043)","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital. 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( Site 2206)","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Cancerologico del Caribe LTD ( Site 2209)","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 2203)","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Cancerologia ( Site 2211)","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMAT S.A.S ( Site 2202)","city":"Montería","state":"Departamento de Córdoba","country":"Colombia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Oncologos Del Occidente ( Site 2208)","city":"Pereira","state":"Risaralda Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice Ostrava ( Site 3505)","city":"Ostrava - Poruba","state":"Moravian-Silesian Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vseobecna fakultni nemocnice v Praze ( Site 3501)","city":"Prague","state":"Praha 2","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Masarykuv onkologicky ustav ( Site 3500)","city":"Brno","state":"South Moravian","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice Olomouc ( Site 3502)","city":"Olomouc","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni Thomayerova nemocnice ( Site 3506)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultní nemocnice Motol a Homolka ( Site 3503)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet University Hospital ( Site 3201)","city":"Copenhagen","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herlev og Gentofte Hospital. 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Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital ( Site 4001)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospital ( Site 4007)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nottingham University Hospital NHS Trust ( Site 4009)","city":"Nottingham","state":"Nottinghamshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Musgrove Park Hospital ( Site 4005)","city":"Taunton","state":"Somerset","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham ( Site 4017)","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre Hospital ( Site 4008)","city":"Cardiff","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. James s University Hospital ( Site 4004)","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-Free Survival (PFS) (sac-TMT versus treatment of physician's choice (TPC); sac-TMT plus pembrolizumab versus TPC)","Overall Survival (OS) (sac-TMT versus TPC)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["mobile-alabama","chandler-arizona","duarte-california","irvine-california","los-angeles-california","san-francisco-california","new-haven-connecticut","washington-d-c-district-of-columbia","altamonte-springs-florida","orlando-florida","west-palm-beach-florida","athens-georgia","boise-idaho","chicago-illinois","baltimore-maryland","clinton-maryland","olney-maryland","silver-spring-maryland","grand-rapids-michigan","minneapolis-minnesota","hattiesburg-mississippi","las-vegas-nevada","reno-nevada","hackensack-new-jersey","albuquerque-new-mexico","mineola-new-york","new-york-new-york","garner-north-carolina","nashville-tennessee","dallas-texas","el-paso-texas","houston-texas","san-antonio-texas","salt-lake-city-utah","norfolk-virginia","seattle-washington","mar-del-plata-argentina","c-rdoba-argentina","viedma-argentina","rosario-argentina","mendoza-argentina","blacktown-australia","frankston-australia","antwerp-belgium","genk-belgium","ghent-belgium","recife-brazil","natal-brazil","porto-alegre-brazil","barretos-brazil","s-o-jose-do-rio-preto-brazil","s-o-paulo-brazil","edmonton-canada","oshawa-canada","toronto-canada","chicoutimi-canada","montreal-canada","qu-bec-canada","saskatoon-canada","concepci-n-chile","la-serena-chile","santiago-chile","vi-a-del-mar-chile","bengbu-china","chongqing-china","xiamen-china","guangzhou-china","nanning-china","zhengzhou-china","wuhan-china","xiangyang-china","changsha-china","nanjing-china","xuzhou-china","changchun-china","xian-china","jinan-china","linyi-china","taiyuan-china","chengdu-china","neijiang-china","r-mqi-china","hangzhou-china","linhai-china","medell-n-colombia","barranquilla-colombia","bogot-colombia","monter-a-colombia","pereira-colombia","ostrava-poruba-czechia","prague-czechia","brno-czechia","olomouc-czechia","copenhagen-denmark","aarhus-denmark","odense-denmark","oulu-finland","tampere-finland","helsinki-finland","lyon-france","limoges-france","montpellier-france","saint-herblain-france","reims-france","rouen-france","toulon-france","paris-france","erlangen-germany","d-sseldorf-germany","essen-germany","saarbr-cken-germany","leipzig-germany","berlin-germany","athens-greece","heraklion-greece","larissa-greece","thessaloniki-greece","hong-kong-hong-kong","gyula-hungary","szeged-hungary","budapest-hungary","debrecen-hungary","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","misterbianco-italy","rome-italy","bologna-italy","genova-italy","milan-italy","novara-italy","padova-italy","perugia-italy","roma-italy","nagoya-japan","kashiwa-japan","matsuyama-japan","sapporo-japan","kahoku-gun-japan","isehara-japan","kawasaki-japan","sagamihara-japan","yokohama-japan","tsu-japan","naha-japan","suita-japan","hidaka-japan","bunkyo-japan","koto-japan","minato-japan","shinagawa-japan","shinjuku-japan","akita-japan","fukuoka-japan","fukushima-japan","hiroshima-japan","kagoshima-japan","kyoto-japan","okayama-japan","osaka-japan","putrajaya-malaysia","kuching-malaysia","kuala-lumpur-malaysia","guadalajara-mexico","benito-ju-rez-mexico","mexico-city-mexico","monterrey-mexico","san-pedro-garza-garc-a-mexico","oaxaca-city-mexico","aguascalientes-mexico","chihuahua-city-mexico","san-luis-potos-city-mexico","arnhem-netherlands","sittard-geleen-netherlands","tilburg-netherlands","deventer-netherlands","rotterdam-netherlands","amersfoort-netherlands","groningen-netherlands","newmarket-new-zealand","crofton-downs-new-zealand","lima-peru","lipa-philippines","manila-philippines","iloilo-city-philippines","poznan-poland","bydgoszcz-poland","krakow-poland","siedlce-poland","warsaw-poland","wieliszew-poland","bialystok-poland","gdynia-poland","koszalin-poland","cluj-napoca-romania","comuna-floresti-romania","craiova-romania","ploie-ti-romania","timi-oara-romania","bucharest-romania","goyang-si-south-korea","seongnam-south-korea","daegu-south-korea","seoul-south-korea","seville-spain","lhospitalet-de-llobregat-spain","madrid-spain","valencia-spain","barcelona-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkoknoi-thailand","hat-yai-thailand","khon-kaen-thailand","bornova-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","sakarya-turkey-t-rkiye","samsun-turkey-t-rkiye","cherkasy-ukraine","ivano-frankivsk-ukraine","khmelnytskyi-ukraine","kropyvnytskyi-ukraine","lviv-ukraine","rivne-ukraine","vinnytsia-ukraine","lutsk-ukraine","uzhhorod-ukraine","kyiv-ukraine","truro-united-kingdom","london-united-kingdom","nottingham-united-kingdom","taunton-united-kingdom","birmingham-united-kingdom","cardiff-united-kingdom","leeds-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Sacituzumab tirumotecan for Triple Negative Breast Neoplasms","inPlainEnglish":"Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent","Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer","Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence","Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin","Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Pembrolizumab, or Rescue Medication. The registry lists allocation as randomized. Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 285 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.943Z"},{"nctId":"NCT06842186","title":"A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity","officialTitle":"A Phase 1/2a, Randomized, Double-blind, Placebo-controlled Study of Ascending Doses of WVE-007 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults Living With Overweight or Obesity","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Wave Life Sciences USA, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity. The Part B of the study is a repeat dose administration in adult with obesity, with or without Type 2 Diabetes (T2D and non-T2D, respectively). In addition, Part B includes two dose groups that will receive WVE-007 and tirzepatide in adults living with obesity and T2D.","conditions":["Overweight and Obesity"],"keywords":[],"interventions":[{"type":"DRUG","name":"WVE-007"}],"enrollment":400,"startDate":"2025-01-31","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria: Part A\n\n* Male and female participants aged 18 to 60 years\n* BMI 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, BMI 28 to 40 kg/ m2 will be allowed.\n* Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments\n\nInclusion Criteria : Part B\n\n* Male and female participants aged 18 to 75 years\n* BMI 35 to 50 kg/m2 (inclusive)\n* Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days\n* Participants with or without Type 2 Diabetes (T2D and non-T2D, respectively)\n\nExclusion Criteria: Part A\n\n* History or presence of CV disease, including heart failure (New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments\n* History or presence of thyroid disorders\n* Medical history or diagnosis of causes of liver disease\n* Use of any siRNA agent in the prior 12 months\n* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study\n\nExclusion Criteria: Part B\n\n* History of significant CV disease in the opinion of the Investigator.\n* Use of prescription medications (ie, anti-obesity or psychiatric medications) within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug, except for allowed antihypertensive medications and lipid lowering medications.\n* Taking \\>3 antihypertensive medications, or antihypertensive medication dose was changed in the 60 days prior to Screening.\n* Taking \\>2 cholesterol-lowering medication, or cholesterol-lowering medication dose was changed in the 60 days prior to Screening.\n* Cohorts 1 and 2 only: use of any GLP-1 receptor agonists or dual incretin agonists within the 4 months prior to Screening.\n* Cohorts 4 to 7 only: use of sulfonylurea and meglitinides within 60 days prior to Screening and insulin, GLP-1 receptor agonist, and dual incretin agonist within 90 days prior to Screening\n* Cohorts 6 and 7 only: Known serious hypersensitivity to tirzepatide or any excipients\n* Diagnosis of Type 1 diabetes mellitus, or dependence on daily or ongoing use of insulin or insulin analogs for glycemic control.\n* Use of any siRNA agent in the prior 12 months.\n* Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study.","locations":[{"facility":"Arensia Exploratory Medicine, Inc. USA","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Parexel International-EPCU Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARENSIA Research Clinic","city":"Chisinau","state":"","country":"Moldova","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arensia Clinics S.R.L.","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean De Urgenta Cluj","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parexel International Early Phase Clinical Unit","city":"Harrow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Simbec-Orion Clinical Pharmacology","city":"Merthyr Tydfil","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Operations","phone":"855-215-4687","email":"Clinicaltrials@wavelifesci.com"}],"primaryOutcomes":["The proportion of participants with treatment emergent adverse events"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["phoenix-arizona","baltimore-maryland","chisinau-moldova","bucharest-romania","cluj-napoca-romania","harrow-united-kingdom","merthyr-tydfil-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing WVE-007 for Overweight and Obesity","inPlainEnglish":"This study wants to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) . Part A is a single ascending dose study in adults living with overweight and obesity.","whoItsFor":["Ages 18 Years to 75 Years","Male and female participants aged 18 to 60 years","body-mass index (BMI) 28 to 35 kg/m2 which has been stable (±5%) for the previous 3 to 6 months (based on participant self-report or medical records). For participants considered for enrollment in a cohort expansion, body-mass index (BMI) 28 to 40 kg/ m2 will be allowed","Healthy, in the opinion of the Investigator, as determined by prestudy medical history, physical examination, and clinical laboratory assessments","who can join : Part B","Male and female participants aged 18 to 75 years","body-mass index (BMI) 35 to 50 kg/m2 (inclusive)","Thyroid stimulating hormone is within normal range at Screening. May be on supplemental thyroid hormone as managed by their prescribing physician and stable within the last 60 days"],"whoShouldSkip":["History or presence of CV disease, including heart failure (New York Heart Association \\[NYHA\\] Class III or IV), myocardial infarction, angina, or clinically significant abnormal laboratory assessments","History or presence of thyroid disorders","Medical history or diagnosis of causes of liver disease","Use of any siRNA agent in the prior 12 months","Received an investigational agent within 90 days or 5 half-lives, whichever is longer, before the first dose of study drug or are in follow-up of another clinical study"],"whatHappens":"If you join, the listed intervention(s) are WVE-007. The registry lists allocation as randomized. This study wants to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending doses of WVE-007 when administered subcutaneously (SC) .","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 400 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.023Z"},{"nctId":"NCT06843447","title":"A Clinical Study of Raludotatug Deruxtecan in People With Ovarian Cancer (MK-5909-003).","officialTitle":"A Phase 1b/2 Open-label, Multicenter Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan With or Without Other Anticancer Investigational Agents in Participants With Advanced High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (REJOICE-Ovarian02)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes.\n\nStandard treatment (usual treatment) for people with high-grade serous ovarian cancer may include:\n\n* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing\n* Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread\n\nRaludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.","conditions":["Ovarian Cancer Recurrent"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Raludotatug Deruxtecan"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"DRUG","name":"Rescue Medication"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Pegylated liposomal doxorubicin"},{"type":"DRUG","name":"MK-2010"}],"enrollment":605,"startDate":"2025-04-15","completionDate":"2029-03-27","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer\n* Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1\n* Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)\n* Participants in Cohort B-1 and Cohort B-2: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression \\<6 months (\\<180 days) after the last dose of platinum-based therapy (ie, platinum-resistant disease). Participants must have received no more than 1 prior bevacizumab-containing systemic treatment regimen\n* Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment\n* Has provided tumor tissue for biomarker research (all cohorts)\n* Has an Eastern Cooperative Oncology Group performance status of 0 to 1\n* Participants in Cohort C-1, Cohort C-2 Arm 3, Cohort D, and Cohort E-1: Has relapsed disease after 1 prior line of therapy, radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease) and progressed during prior treatment with poly-ADP ribose polymerase inhibitor (PARPi) in the first-line setting\n* Participants in Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)\n* Participants in Cohort C-2 Arms 1 and 2: Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics Stage III or Stage IV epithelial ovarian cancer (high-grade serous or high-grade endometrioid), fallopian tube cancer, or primary peritoneal cancer that is non-homologous recombination deficiency-positive\n* Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, PARPi first-line maintenance treatment for non- homologous recombination deficiency (HRD)-positive disease is not the preferred option for the participant\n* Participants in Cohort C-2 Arms 1 and 2: According to the investigator's assessment, bevacizumab treatment for non-HRD-positive disease is not the preferred option for the participant\n\nExclusion Criteria:\n\n* Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event\n* Has uncontrolled or significant cardiovascular disease\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement, or prior pneumonectomy\n* Has ≥Grade 2 peripheral neuropathy\n* Has received prior treatment with cadherin-6-targeted agents\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation\n* Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Receives chronic steroid treatment\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active CNS metastases and/or carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of prior steroid use, current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening\n* Has active infection requiring systemic therapy\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","locations":[{"facility":"Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 0019)","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Louisville, James Graham Brown Cancer Center ( Site 0009)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TRIALS 365 ( Site 0020)","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute ( Site 0015)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center ( Site 0003)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OU Health University of Oklahoma Medical Center ( Site 7000)","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8000)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital ( Site 0010)","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"START Mountain Region ( Site 0008)","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Health System ( Site 0011)","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western Health-Sunshine & Footscray Hospitals ( Site 1002)","city":"St Albans","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0101)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 0102)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre ( Site 0100)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0202)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center ( Site 0201)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 0203)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0200)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center ( Site 2004)","city":"Goyang-si","state":"Kyonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 2000)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System ( Site 2002)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 2003)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia - L'Hospitalet ( Site 0302)","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA ( Site 0307)","city":"Majadhonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra ( Site 0301)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario de Valencia ( Site 0305)","city":"Valencia","state":"Valenciana, Comunitat","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0300)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0303)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 0304)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria ( Site 0306)","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel-Gynecology & Gynecologic Oncology ( Site 0802)","city":"Basel","state":"Canton of Basel-City","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHUV (centre hospitalier universitaire vaudois) ( Site 0800)","city":"Lausanne","state":"Canton of Vaud","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOCH Health Ostschweiz ( Site 0801)","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital ( Site 3001)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation-Linkou Branch ( Site 3002)","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Sussex NHS Foundation Trust ( Site 0404)","city":"Brighton","state":"East Sussex","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital ( Site 0402)","city":"Fulham","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden NHS Foundation Trust. ( Site 0403)","city":"Sutton","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust ( Site 0401)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy s & St Thomas NHS Foundation Trust ( Site 0400)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust ( Site 0405)","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part 1: Number of Participants Who Experience a Dose-limiting Toxicity (DLT) Per Common Terminology Criteria for Adverse Events, Version 5.0 (CTCAE v5.0)","Part 1: Number of Participants with One or More Adverse Events (AEs)","Part 1: Number of Participants who Discontinue Study Intervention Due to an AE","Part 2: Objective Response Rate (ORR)","Part 2: Progression Free Survival (PFS) - Cohort C-2 Arm 1 and Arm 2"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["new-haven-connecticut","louisville-kentucky","shreveport-louisiana","boston-massachusetts","new-york-new-york","oklahoma-city-oklahoma","fort-worth-texas","houston-texas","west-valley-city-utah","charlottesville-virginia","st-albans-australia","toronto-canada","montreal-canada","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","goyang-si-south-korea","seoul-south-korea","lhospitalet-de-llobregat-spain","majadhonda-spain","madrid-spain","valencia-spain","barcelona-spain","m-laga-spain","basel-switzerland","lausanne-switzerland","sankt-gallen-switzerland","taipei-taiwan","taoyuan-taiwan","brighton-united-kingdom","fulham-united-kingdom","sutton-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Raludotatug Deruxtecan for Ovarian Cancer Recurrent","inPlainEnglish":"Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly.","whoItsFor":["Ages 18 Years to any","Women only","Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer","Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has measurable disease per Response Evaluation Criteria In Solid Tumors 1.1","Participants in Cohort A-1 Arms 2 and 3: Has relapsed disease after 1 to 3 prior lines of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)","Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in Cohort D or Cohort A-2 Arms 1, 2, or 3: Is a candidate for bevacizumab treatment","Has provided tumor tissue for biomarker research (all cohorts)","Has an Eastern Cooperative Oncology Group performance status of 0 to 1","Participants in Cohort A-2 Arms 1, 2, and 3: Has relapsed disease after 1 prior line of therapy and radiographic evidence of disease progression ≥6 months (≥180 days) after the last dose of platinum-based therapy (ie, platinum-sensitive disease)"],"whoShouldSkip":["Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event","Has uncontrolled or significant cardiovascular disease","Has ≥Grade 2 peripheral neuropathy","Has received prior treatment with cadherin-6-targeted agents","Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before allocation","Has received prior radiotherapy within 2 weeks of the start of study intervention, or has radiation-related toxicities, requiring corticosteroids","Receives chronic steroid treatment"],"whatHappens":"If you join, the listed intervention(s) are Raludotatug Deruxtecan, Carboplatin, or Paclitaxel. The registry lists allocation as randomized. Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 605 people at 41 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.156Z"},{"nctId":"NCT06843902","title":"Improving Coronary Vascular Health in Women","officialTitle":"ImproviNg Coronary Vascular Health in Women With Risk Factors fOR Myocardial Infarction Type 2 (INFORM-2)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed. We are conducting a study randomizing women with HIV and either diabetes, chronic kidney disease, or both to health education alone or to health education plus referral to see either an Endocrinologist or a Nephrologist in a subspecialty clinic for consideration of treatment with medication in a class known as sodium glucose transporter 2 (SGLT2) inhibitors. SGLT2 inhibitors are clinically approved for use in patients with diabetes or chronic kidney disease but have been shown to be underutilized in people with HIV. One of our key analytic aims will be to test if SGLT2 inhibitor therapy results in improved blood flow through the large and small coronary arteries among women with HIV and either diabetes, chronic kidney disease, or both but who have no history of myocardial infarction. A second aim will be to test if subspecialty clinic referral (with or without SGLT2 inhibitor therapy prescription) results in improved blood flow through the large and small coronary arteries among the same group.","conditions":["HIV-1-infection","Coronary Microvascular Dysfunction","Metabolic Disease"],"keywords":["HIV","women","diabetes","chronic kidney disease","SGLT2 inhibitor therapy","coronary flow reserve","cardiovascular disease prevention"],"interventions":[{"type":"OTHER","name":"Health Education"},{"type":"OTHER","name":"Subspecialty clinic referral"}],"enrollment":80,"startDate":"2025-04-17","completionDate":"2029-03","sex":"FEMALE","minAge":"45 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* female sex-at-birth\n* self-report of HIV on stable antiretroviral therapy ≥180 days\n* age 45 -75 years\n* at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine albumin to creatinine ratio \\>30 mg/g\n* coronary flow reserve \\<2.5 or stress myocardial blood flow \\<2.5 on screening cardiac positron emission tomography/computed tomography\n\nExclusion Criteria:\n\n* current SGLT2 inhibitor use\n* known allergy to SGLT2 inhibitor use\n* type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)\n* self-reported history of polycystic kidney disease\n* self-reported history of myocardial infarction, stroke, or coronary revascularization\n* stable or unstable angina\n* self-reported history of heart failure\n* hemoglobin A1c ≥8.5% at screen\n* uncontrolled hypertension at screen, defined as systolic blood pressure ≥180 mm Hg and/or diastolic blood pressure ≥110 mm Hg\n* estimated glomerular filtration rate \\<30 ml/min/1.73 m2\n* currently receiving hemodialysis or peritoneal dialysis\n* CD4 \\<400 cell/mm3\n* current treatment with systemic (oral, IV, IM or intra-articular) steroids or anti-inflammatory/immune suppressant therapies (excluding topical therapies, UV therapy, ASA-derivatives, or NSAIDs) for any indication, including kidney disease\n* pregnancy or breastfeeding\n* known allergy to 13N Ammonia/82Rubidium or to Regadenoson/Adenosine\n* concurrent enrollment in conflicting research study\n* self-reported history of recurrent urinary tract-infections (≥2 urinary tract infections within 6 months or ≥3 within a year) and/or recurrent vaginal yeast infections (≥2 vaginal yeast infections within 6 months or ≥3 within a year)\n* currently receiving 24-hour-a-day home oxygen therapy","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Chu, NP","phone":"617-724-6091","email":"schu4@mgh.harvard.edu"}],"primaryOutcomes":["Coronary Flow Reserve","Ectopic Adipose Tissue"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","hiv"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: Health Education for HIV-1-infection","inPlainEnglish":"Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV. One of the mechanisms underlying the increased risk of myocardial infarction among women with HIV may involve reduced ability to increase blood flow through large and small coronary arteries at times when increased flow of oxygen-carrying blood is needed.","whoItsFor":["Ages 45 Years to 75 Years","Women only","female sex-at-birth","self-report of HIV on stable antiretroviral therapy ≥180 days","at least 1 of the following 3 conditions: i) type 2 diabetes mellitus ii) estimated glomerular filtration rate 30-60 ml/min/1.73 m2 iii) urine albumin to creatinine ratio \\>30 mg/g","coronary flow reserve \\<2.5 or stress myocardial blood flow \\<2.5 on screening cardiac positron emission tomography/computed tomography"],"whoShouldSkip":["current SGLT2 inhibitor use","known allergy to SGLT2 inhibitor use","type 1 diabetes or ketoacidosis prone diabetes (diabetes with a history of ketoacidosis)","self-reported history of polycystic kidney disease","self-reported history of myocardial infarction, stroke, or coronary revascularization","stable or unstable angina","self-reported history of heart failure"],"whatHappens":"If you join, the listed intervention(s) are Health Education, or Subspecialty clinic referral. The registry lists allocation as randomized. Women with HIV have an increased risk of having a myocardial infarction (heart attack) as compared to women without HIV.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.618Z"},{"nctId":"NCT06843967","title":"A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma","officialTitle":"A Phase Ib/II Study of the Mirdametinib in Combination With Palbociclib in Patients With Advanced Dedifferentiated Liposarcoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma. This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.","conditions":["Well Differentiated Liposarcoma","Dedifferentiated Liposarcoma","Liposarcoma","Myxoid Liposarcoma","Round Cell Liposarcoma","Myxoid Pleomorphic Liposarcoma","Pleomorphic Liposarcoma","Unresectable Liposarcoma","Unresectable Dedifferentiated Liposarcoma"],"keywords":["Well Differentiated Liposarcoma","Dedifferentiated Liposarcoma","Liposarcoma","Myxoid Liposarcoma","Round Cell Liposarcoma","Myxoid Pleomorphic Liposarcoma","Pleomorphic Liposarcoma","Unresectable Liposarcoma","Unresectable Dedifferentiated Liposarcoma","Unresectable Well Differentiated Liposarcoma","24-344","Memorial Sloan Kettering Cancer Center"],"interventions":[{"type":"DRUG","name":"Mirdametinib"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":54,"startDate":"2025-02-19","completionDate":"2028-08-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPhase I only:\n\n* A diagnosis of unresectable, recurrent, or metastatic DDLPS\n* Measurable disease as defined by RECIST 1.1\n\nPhase II only:\n\n* A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS\n* Any number of prior lines of therapy\n\n  * Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration)\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):\n* Absolute neutrophil count ≥ 1.5 x 109/L\n* Hemoglobin ≥ 9.0 g/dL\n* Platelets ≥ 100 x 109/L\n* Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN, except patients with Gilbert's disease (≤3x ULN)\n* AST (SGOT) /ALT (SGPT) ≤ 1.5 x institutional ULN\n* Creatinine Clearance ≥ 60 mL/min (calculated by Cockcroft-Gault method)\n\n  * Adequate coagulation function, as determined by:\n* International Normalized Ratio (INR) ≤ 1.5 × ULN (Grade ≤ 1). If the participant receives anticoagulant therapy, the INR \\> 1.5 × ULN is permitted but the dose must be stable for at least 2 weeks before the start of the study treatments.\n* PTT ≤ 1.5 × ULN.\n\n  * Adequate cardiac function, as determined by:\n* Systolic blood pressure \\< 160 mmHg and diastolic blood pressure \\< 100 mmHg (Grade ≤ 2).\n* LVEF ≥ 50% by MUGA or ECHO.\n* No clinically significant ECG waveform abnormalities assessments at screening.\n\n  * Adequate glycemic control, as determined by:\n* Fasting blood glucose level \\< 125 mg/dL, or\n* Random blood glucose level \\< 200 mg/dL.\n\n  * Have normal serum calcium and phosphate levels (calcium level may be corrected for albumin level).\n  * Have intraocular pressure ≤ 21 mmHg in both eyes\n  * Women of child-bearing potential must agree to use highly effective contraceptive methods (hormonal or barrier method of birth control or abstinence) during the trial period through at least six months after the last dose. Male patients or their partners must be surgically sterile or agree to use adequate contraception while receiving trial treatment and for three months thereafter. Acceptable methods of contraceptive use by men or women are detailed in Section 15.3.\n  * Ability to understand and the willingness to sign a written informed consent document.\n  * Ability to swallow tablets or capsules\n  * Patients with brain metastasis that have been treated with definitive surgery or radiation, and have been clinically stable for 3 months are eligible.\n\nExclusion Criteria:\n\n* Patients who have not recovered from clinically significant adverse events of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline.\n* Patients receiving any other investigational agents.\n* Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor\n* Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including uncontrolled HIV, active hepatitis B or C, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmias, psychiatric illness/social situations that would limit compliance with study requirements, clinically significant interstitial lung disease or active noninfectious pneumonitis, or active infection requiring systemic therapy.\n\n  * Patients with a CD4+ count of \\> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion.\n  * Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded.\n  * Patients with history of clinically significant cardiac disease (New York Heart Association Class III or IV), myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, clinically significant transient ischemic attack, symptomatic pulmonary embolism, unexplained syncope, or long QT syndrome within 6 months before the start of study treatment will be excluded.\n* Pregnant women and women who are breast-feeding.\n* Prolonged QTcF \\> 470ms at Screening, irrespective of sex.\n\n  o If a single 12-lead electrocardiogram (ECG) or, for patients with prolonged QT intervals or other cardiac indications, a triplicate ECG should be performed.\n* Current Chronic Kidney Disease stage \\> 3 or Creatinine Clearance \\< 60 mL/min (calculated by Cockcroft-Gault method)\n* Current or history of Interstitial Lung Disease\n* History or current evidence of glaucoma or clinically significant abnormalities on the ophthalmological exam, including but not limited to cataract limiting the ability to examine the retina or any ophthalmological finding that could be a significant risk factor for RVO, retinopathy or neovascular macular degeneration.\n* Concurrent neuromuscular disorder that is associated with the potential of elevated CPK (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy).\n* Radiation therapy within 2 weeks prior to study Day 1\n* Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1, without complete recovery.\n* Patient is receiving systemic (oral or IV/SC) or ocular glucocorticoid therapy (with the exception of participants with endocrine deficiencies who are allowed to receive physiologic or stress doses of steroids, if necessary) within 14 days prior to first dose of study treatment\n* Known prior severe hypersensitivity to investigational product or any component in its formulation.\n\n  o This includes hypersensitivity to imidazoles, such as clotrimazole, ketoconazole, miconazole and others in this drug class. Subjects with hypersensitivity to these agents will be excluded from enrollment.\n* History of significant toxicity related to prior CDK4/6, MEK, or ERK inhibitor requiring discontinuation of treatments with these agents.\n* Concurrent, clinically significant, active malignancies within 12 months of study enrollment\n* Current evidence of a disorder that could reduce the ability to swallow oral dosage forms or alter absorption of orally administered drugs.\n* Patients who require concomitant use of medications that strongly induce or inhibit CYP3A or UDP-glucuronosyltransferase (UGT)\n* Non-tolerable Grade 2 or ≥ Grade 3 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. 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This study will test different doses of mirdametinib in combination with a fixed dose of palbociclib to find the best safe dose for further testing.","whoItsFor":["Ages 18 Years to any","A diagnosis of unresectable, recurrent, or metastatic DDLPS","Measurable disease as defined by RECIST 1.1","A diagnosis of unresectable, recurrent (e.g. recurrent retroperitoneal) or metastatic DDLPS","Any number of prior lines of therapy","Measurable disease and evidence of progression of disease as defined by RECIST 1.1 (including newly diagnosed disease, new disease sites in a patient who was previously NED, or a 20% growth of existing lesions within 6 months of registration)","how well you can do daily activities (ECOG score) ≤ 2","Adequate organ and marrow function as defined below (ULN indicates institutional upper limit of normal):"],"whoShouldSkip":["Patients who have not recovered from clinically significant side effects of prior therapy to ≤ NCI CTCAE v5 Grade 1, except alopecia and stable neuropathy, which must have resolved to ≤ Grade 2 or baseline","Patients receiving any other investigational agents","Phase II only: Receipt of prior treatment with a selective CDK4 inhibitor or MEK inhibitor","Patients with a CD4+ count of \\> 300 and an undetectable viral load who are currently on HAART are eligible for inclusion","Patients with NYHA class III or IV congestive heart failure within 6 months of study treatment will be excluded","Pregnant women and women who are breast-feeding","Prolonged QTcF \\> 470ms at Screening, irrespective of sex"],"whatHappens":"If you join, the listed intervention(s) are Mirdametinib, or Palbociclib. The registry lists allocation as randomized. This study wants to find out whether mirdametinib in combination with palbociclib is an effective and safe treatment for people with metastatic, recurrent, and unresectable liposarcoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.725Z"},{"nctId":"NCT06846281","title":"Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.","officialTitle":"A Randomized, Open-label, Parallel-group, Non-inferiority Study Comparing Efficacy, Safety, and Tolerability of Remibrutinib 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Part"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["scottsdale-arizona","irvine-california","washington-d-c-district-of-columbia","altamonte-springs-florida","gainesville-florida","hollywood-florida","maitland-florida","miami-florida","naples-florida","orlando-florida","tallahassee-florida","tampa-florida","vero-beach-florida","chicago-illinois","kansas-city-kansas","olney-maryland","boston-massachusetts","burlington-massachusetts","foxborough-massachusetts","farmington-hills-michigan","owosso-michigan","st-louis-missouri","las-vegas-nevada","teaneck-new-jersey","albuquerque-new-mexico","buffalo-new-york","chapel-hill-north-carolina","raleigh-north-carolina","fargo-north-dakota","centerville-ohio","cincinnati-ohio","cleveland-ohio","columbus-ohio","portland-oregon","greenville-south-carolina","knoxville-tennessee","austin-texas","dallas-texas","fort-worth-texas","plano-texas","richmond-virginia","greenfield-wisconsin","milwaukee-wisconsin","rosario-argentina","buenos-aires-argentina","caba-argentina","melbourne-australia","parkville-australia","liverpool-australia","st-leonards-australia","bruges-belgium","overpelt-belgium","fortaleza-brazil","porto-alegre-brazil","joinville-brazil","s-o-paulo-brazil","edmonton-canada","vancouver-canada","l-vis-canada","montreal-canada","brno-czechia","hradec-kr-lov-czechia","jihlava-czechia","pardubice-czechia","prague-czechia","aarhus-n-denmark","glostrup-municipality-denmark","bordeaux-france","clermont-ferrand-france","lille-france","marseille-france","nice-france","n-mes-france","paris-france","poitiers-france","strasbourg-france","toulouse-france","tours-france","marburg-germany","berlin-germany","bochum-germany","erbach-im-odenwald-germany","essen-germany","greifswald-germany","heidelberg-germany","m-nster-germany","ulm-germany","cha-d-ri-greece","larissa-greece","thessaloniki-greece","bergamo-italy","foggia-italy","genova-italy","milan-italy","pavia-italy","roma-italy","mexico-city-mexico","braga-portugal","coimbra-portugal","lisbon-portugal","bratislava-slovakia","trnava-slovakia","cape-town-south-africa","pretoria-south-africa","el-palmar-spain","valencia-spain","barcelona-spain","c-rdoba-spain","madrid-spain","m-laga-spain","seville-spain","bern-switzerland","lausanne-switzerland","zurich-switzerland","sheffield-united-kingdom","leeds-united-kingdom","london-united-kingdom","swansea-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Remibrutinib oral treatment for Relapsing Multiple Sclerosis","inPlainEnglish":"The purpose of this Phase 3b study is to assess the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).","whoItsFor":["Ages 40 Years to 70 Years","Male or female aged 40 to 70 years (inclusive)","Diagnosis of RMS according to the 2017 McDonald diagnostic criteria","Treated with ocrelizumab according to routine clinical practice and at standard dose","Neurologically stable within 30 days","Suitable to be switched to remibrutinib based on physician judgement or patient preference"],"whoShouldSkip":["Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria","History of clinically significant Central Nervous System disease or neurological disorders","History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent","Active clinically significant systemic bacterial, viral, parasitic or fungal infections","Active, chronic disease of the immune system other than MS","Severe cardiac disease or significant findings on the ECG","Participant who is unable to undergo MRI scans"],"whatHappens":"If you join, the listed intervention(s) are Remibrutinib oral treatment, or Ocrelizumab. The registry lists allocation as randomized. The purpose of this Phase 3b study is to assess the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 122 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.990Z"},{"nctId":"NCT06847165","title":"Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure","officialTitle":"Trigeminal Nerve Stimulation for Children With Prenatal Alcohol Exposure","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, Los Angeles","sponsorClass":"OTHER","summary":"This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition. But this will be the first time it is tried for ADHD specifically associated with PAE. In TNS, a weak electric current is applied to the child's forehead overnight while sleeping to gently stimulate the brain. TNS is administered at home by the parent to the child. TNS is safe and well tolerated. Efficacy of TNS in ADHD is \\~50%. The purpose of the present pilot study is to determine the feasibility of TNS for children with PAE and ADHD. Feasibility means safety (any serious side effects?), tolerability (do children comply with TNS? are they comfortable with it?), and a rough idea of efficacy (does TNS seem to work in most kids?) A secondary goal of the study is to get a more precise idea of brain mechanisms of TNS with magnetic resonance imaging (MRI). Families who participate will make three clinic visits: eligibility (4-5 hours), pre-TNS (2-3 hours including MRI), and post-TNS (2-3 hours including MRI). Children will receive TNS, applied by the parent, for 8 hours every night while sleeping for 4 weeks. Four weeks after treatment, families will take part in a telephone follow-up, to see whether any improvements made last.","conditions":["Fetal Alcohol Spectrum Disorders","Attention Deficit Hyperactivity Disorder"],"keywords":["prenatal alcohol exposure","attention deficit hyperactivity disorder","trigeminal nerve stimulation"],"interventions":[{"type":"DEVICE","name":"Trigeminal Nerve Stimulation (TNS)"}],"enrollment":30,"startDate":"2025-04-26","completionDate":"2026-12-29","sex":"ALL","minAge":"8 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \\- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria (thus positive maternal drinking in pregnancy required, facial stigmata not required)\n* Prenatal alcohol exposure (PAE) \\>6 drinks/week for \\>= 2 weeks and/or \\>= 3 drinks on \\>= 2 occasions throughout gestation per Health Interview for Women/Health Interview for Adoptive and Foster Parents (HIW/HIAFP)\n* Diagnosis of Diagnostic and Statistical Manual 5th edition (DSM-5) attention deficit hyperactivity disorder (ADHD), including problems with inattention, hyperactivity, impulsivity, and/or executive function. Screening for ADHD will be done using the Swanson, Nolan, and Pelham Teacher and Parent Rating Scale (SNAP IV). Formal diagnosis of ADHD will be based on the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) with input from the Behavior Rating of Executive Function (BRIEF II) and the Conners 4.\n* Parent and child able to complete testing in English\n* Child able to cooperate during MRI\n* Full-Scale Intelligence Quotient \\>70 per the Kaufman Brief Intelligence Test (K-BIT-2)\n* Child able to comply with study procedures\n* Age 8-12\n\nExclusion Criteria:\n\n* \\- Other toxic exposure per HIW/HIAFP whose influence clearly surpasses that of alcohol (very rare) per study clinician judgement\n* Known genetic syndrome associated with ADHD-like symptoms including fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone\n* Serious medical or neurologic illness likely to influence brain function, e.g., seizures, closed-head trauma\n* Gestation \\< 34 weeks\n* Ferromagnetic metal, claustrophobia, or other MRI or TNS contraindication (e.g., insulin pumps or other body-worn devices)\n* Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder\n* Active suicidal ideation as evidenced by meeting criteria for \"Current\" or \"Lifetime attempt\" on the Suicidality module or \"Current' or 'In early remission' on the Suicide Behavior Disorder module of the MINI KID","locations":[{"facility":"University of California Los Angeles Semel Institute Division of Child & Adolescent Psychiatry","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer M Korthas, BS","phone":"(310) 267-2710","email":"ChildBrainStudy@mednet.ucla.edu"},{"name":"Joseph O'Neill, PhD","phone":"(310) 825-5709","email":"joneill@mednet.ucla.edu"}],"primaryOutcomes":["Attention Deficit Hyperactivity Disorder (ADHD) Rating Scale Total Score"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: Trigeminal Nerve Stimulation (TNS) for Fetal Alcohol Spectrum Disorders","inPlainEnglish":"This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE). TNS has been successful in treating pediatric ADHD generally and it is US Food and Drug Administration (FDA)-cleared for this condition.","whoItsFor":["Ages 8 Years to 12 Years","\\- Fetal alcohol syndrome, partial fetal alcohol syndrome, or alcohol-related neurodevelopmental disorder per modified Institute of Medicine criteria (thus positive maternal drinking in pregnancy required, facial stigmata not required)","Prenatal alcohol exposure (PAE) \\>6 drinks/week for \\>= 2 weeks and/or \\>= 3 drinks on \\>= 2 occasions throughout gestation per Health Interview for Women/Health Interview for Adoptive and Foster Parents (HIW/HIAFP)","Parent and child able to complete testing in English","Child able to cooperate during MRI","Full-Scale Intelligence Quotient \\>70 per the Kaufman Brief Intelligence Test (K-BIT-2)","Child able to comply with study procedures"],"whoShouldSkip":["\\- Other toxic exposure per HIW/HIAFP whose influence clearly surpasses that of alcohol (very rare) per study clinician judgement","Known genetic syndrome associated with ADHD-like symptoms including fragile X, tuberous sclerosis, or generalized resistance to thyroid hormone","Serious medical or neurologic illness likely to influence brain function, e.g., seizures, closed-head trauma","Gestation \\< 34 weeks","Ferromagnetic metal, claustrophobia, or other MRI or TNS contraindication (e.g., insulin pumps or other body-worn devices)","Diagnosis of autism spectrum disorder, psychotic disorder, or major mood disorder","Active suicidal ideation as evidenced by meeting criteria for \"Current\" or \"Lifetime attempt\" on the Suicidality module or \"Current' or 'In early remission' on the Suicide Behavior Disorder module of the MINI KID"],"whatHappens":"If you join, the listed intervention(s) are Trigeminal Nerve Stimulation (TNS). The registry lists allocation as na. This is an open-label trial of trigeminal nerve stimulation (TNS) for children aged 8-12 years with attention deficit hyperactivity disorder (ADHD) putatively due to prenatal alcohol exposure (PAE).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Los Angeles. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.649Z"},{"nctId":"NCT06847542","title":"A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD","officialTitle":"A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.","conditions":["Neovascular Age-related Macular Degeneration"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Susvimo PDS Implant"},{"type":"DRUG","name":"Ranibizumab"}],"enrollment":250,"startDate":"2025-11-27","completionDate":"2028-11-15","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Initial diagnosis of nAMD within 24 months prior to screening\n* Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening\n* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis\n* Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD\n* BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits\n\nExclusion Criteria:\n\nA. Prior Ocular Treatment\n\nStudy Eye:\n\n* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)\n* Previous treatment with corticosteroid intravitreal injection\n* Previous intraocular device implantation\n* History of vitreous hemorrhage\n* History of rhegmatogenous retinal detachment\n* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery\n* History of corneal transplant\n\nEither Eye:\n\n* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study\n* Prior participation in a clinical trial involving any experimental therapies for nAMD\n* Prior treatment with brolucizumab or gene therapy for nAMD\n\nB. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:\n\nStudy Eye:\n\n* Subretinal hemorrhage that involves the center of the fovea\n* Subfoveal fibrosis or subfoveal atrophy\n\nEither Eye:\n\n* CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia\n* CNV masquerading lesions\n\nC. Concurrent Ocular Conditions:\n\nStudy Eye:\n\n* Subfoveal and/or juxtafoveal retinal pigment epithelial tear\n* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results\n* Active intraocular inflammation\n* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit\n* Aphakia or absence of the posterior capsule\n* Uncontrolled ocular hypertension or glaucoma\n* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis\n* Trichiasis\n* Corneal neuropathy\n* Lagophthalmos or incomplete blink\n* Active or history of facial nerve palsy/paresis\n\nFellow (Non-study) Eye:\n\n\\- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)\n\nEither Eye:\n\n* Any active or history of uveitis\n* Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis\n* Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis\n* Active or history of floppy eyelid syndrome\n* Active thyroid eye disease\n\nD. Concurrent Systemic Conditions:\n\n* Uncontrolled blood pressure\n* Active or history of autoimmune diseases\n* History of stroke within the last 3 months prior to informed consent\n* Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent\n* History of myocardial infarction (MI) within the last 3 months prior to informed consent\n* Confirmed active systemic infection\n* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study\n* Use of any systemic anti-VEGF agents\n* Chronic use of oral corticosteroids\n* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer","locations":[{"facility":"Medizinische Universität Innsbruck","city":"Innsbruck","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kepler Universitätskliniken GmbH - Med Campus III","city":"Linz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Landesklinikum Mistelbach","city":"Mistelbach","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt","city":"Mladá Boleslav","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty Hospital Ostrava","city":"Ostrava","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty Hospital Kralovske Vinohrady","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ustredni vojenska nemocnice","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aarhus Universitetshospital","city":"Aarhus N","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet Glostrup","city":"Glostrup Municipality","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Ophtalmologique De l Ouest Jules Verne","city":"Nantes","state":"Paris","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Edouard Herriot - CHU Lyon","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Honore Cave","city":"Montauban","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHNO des Quinze Vingts","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Poitiers - CHR La Miletrie","city":"Poitiers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Strasbourg - Nouvel Hopital Civil","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Chemnitz gGmbH","city":"Chemnitz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätkslinikum Düsseldorf, Augenklinik","city":"Düsseldorf","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Göttingen Georg-August-Universität","city":"Göttingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Hochschule Hannover, Klinik für Augenheilkunde","city":"Hanover","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Rostock","city":"Rostock","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Würzburg, Augenklinik und Poliklinik","city":"Würzburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"\"G.Gennimatas\" General Hospital of Athens","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Attikon University General Hospital","city":"Chaïdári","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital of Heraklion","city":"Heraklon","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Larissa","city":"Larissa","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Monaldi - AORN dei Colli","city":"Naples","state":"Campania","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero - Universitaria di Ferrara - Arcispedale Sant'Anna, Sede Ospedale di Cona;UO di Clinica Oculistica","city":"Cona (Ferrara)","state":"Emilia-Romagna","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST SANTI PAOLO E CARLO - Presidio San Paolo;SC Oculistica","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria Ospedale Maggiore della Carità;S.C.D.U. Oftalmologia","city":"Novara","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Città della Salute e della Scienza di Torino","city":"Turin","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O.U. Policlinico Paolo Giaccone;Oculistica","city":"Palermo","state":"Sicily","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"MW-med","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital sw. Lukasza","city":"Bielsko-Biala","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specjalistyczny O?rodek Okulistyczny Oculomedica","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"OFTALMIKA Sp. z o.o","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA","city":"Gliwice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinika Okulistyczna Jasne Błonia Sp. z o. o.","city":"Lódz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie;Klinika Chirurgii Siatkówki i Cia?a Szklistego","city":"Lublin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Diagnostyki i Mikrochirurgii Oka LENS","city":"Olsztyn","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyungpook National University Hospital","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ajou University Medical Center","city":"Gyeonggi-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"","country":"South Korea","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul St Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boramae Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hallym University Kangnam Sacred Heart Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Jimenez Diaz-UTE","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Arnau de Vilanova (Valencia)","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Berner Augenklinik","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pallas Klinik Olten","city":"Olten","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital St. Gallen","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Chulalongkorn Memorial Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rajavithi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maharaj Nakorn ChiangMai Hospital","city":"Chiang Mai","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Songklanagarind Hospital","city":"Songkhla","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary","city":"Leicester","state":"Leicestershire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bristol Eye Hospital","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gloucestershire Royal Hospital","city":"Gloucester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moorfields Eye Hospital NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S.)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Change From Baseline in Best Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 68 and 72, as Assessed Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart at a Starting Distance of 4 Meters"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["innsbruck-austria","linz-austria","mistelbach-austria","mlad-boleslav-czechia","ostrava-czechia","prague-czechia","aarhus-n-denmark","glostrup-municipality-denmark","nantes-france","lyon-france","montauban-france","paris-france","poitiers-france","strasbourg-france","chemnitz-germany","d-sseldorf-germany","g-ttingen-germany","hanover-germany","rostock-germany","w-rzburg-germany","athens-greece","cha-d-ri-greece","heraklon-greece","larissa-greece","naples-italy","cona-ferrara-italy","rome-italy","milan-italy","novara-italy","turin-italy","palermo-italy","krakow-poland","bielsko-biala-poland","bydgoszcz-poland","gliwice-poland","l-dz-poland","lublin-poland","olsztyn-poland","daegu-south-korea","gyeonggi-do-south-korea","seoul-south-korea","madrid-spain","seville-spain","valencia-spain","bern-switzerland","olten-switzerland","sankt-gallen-switzerland","bangkok-thailand","chiang-mai-thailand","songkhla-thailand","leicester-united-kingdom","bristol-united-kingdom","gloucester-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Ranibizumab for Neovascular Age-related Macular Degeneration","inPlainEnglish":"This study wants to measure the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.","whoItsFor":["Ages 50 Years to any","Initial diagnosis of nAMD within 24 months prior to screening","Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening","Demonstrated response to prior anti-VEGF IVT treatment since diagnosis","Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD","Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD","BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits"],"whoShouldSkip":["A. Prior Ocular Treatment","History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)","Previous treatment with corticosteroid intravitreal injection","Previous intraocular device implantation","History of vitreous hemorrhage","History of rhegmatogenous retinal detachment","History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery"],"whatHappens":"If you join, the listed intervention(s) are Susvimo PDS Implant, or Ranibizumab. The registry lists allocation as na. This study wants to measure the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 250 people at 64 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.139Z"},{"nctId":"NCT06849908","title":"Baricitinib in the Treatment of Intestinal Behçet's Syndrome","officialTitle":"A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Refractory Intestinal Behçet's Syndrome Patients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Peking Union Medical College Hospital","sponsorClass":"OTHER","summary":"This study aims to conduct a randomized controlled trial to compare the efficacy and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS). The objective is to demonstrate if Baricitinib is non-inferior to ADA in controlling BS inflammation, reducing BS recurrence， alleviating gastrointestinal symptoms and promoting intestinal mucosal healing.","conditions":["Behcet Syndrome, Intestinal Type"],"keywords":["Baricitinib","Adalimumab","Intestinal Behçet's Syndrome"],"interventions":[{"type":"DRUG","name":"Baricitinib"},{"type":"DRUG","name":"Adalimumab"}],"enrollment":56,"startDate":"2024-11-08","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Refer to the consensus on the diagnosis and treatment of intestinal Behçet's syndrome in China: Patients who meet the 2013 International Criteria for Behçet's Disease (ICBD) and have typical Behçet's syndrome-related intestinal ulcers confirmed by colonoscopy, or patients diagnosed according to the criteria for Behçet's syndrome established by the Korean Behçet's Disease Collaborative Group in 2009;\n2. Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;\n3. Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;\n4. Patients who have been treated with medium to high-dose steroids (prednisolone equivalent of 0.5-1 mg/kg/day) for more than 1 month continuously, or any immunomodulator/Immunosuppressants for more than 3 months regularly or biologics for more than 2 months, as judged by the doctor to be treatment failure or intolerance;\n5. Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks;\n6. Understanding the research process, voluntary participation, and signing of informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;\n2. Other active organ damage related to BS requires intensified immunosuppressive therapy, including aneurysms, uveitis, and substantial involvement of the central nervous system; skin lesions and joint involvement can be included;\n3. Severe organ dysfunction including ALT, AST, TBIL levels exceeding twice the upper limit of normal, creatinine levels exceeding 1.5 times the upper limit of normal, white blood cell count \\< 3×10\\^9/L, ANC \\< 2×10\\^9/L, hemoglobin \\< 80g/L, platelets \\< 100×10\\^9/L;\n4. Active infections such as active tuberculosis, active hepatitis B or C, syphilis, chronic Epstein-Barr virus infection, HIV infection, sustained or severe bacterial or viral infections, and history of severe herpes zoster;\n5. Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion;\n6. Primary immunodeficiency disease;\n7. History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies;\n8. Patients who did not respond to infliximab treatment for primary refractory BS (patients with secondary failure, intolerance, or allergy to infliximab should be included);\n9. Patients treated with biologics/small molecule targeting therapies within 5 half-lives (including use of tofacitinib within 10 days, etanercept within 4 weeks, infliximab within 8 weeks, golimumab, certolizumab, abatacept, and tocilizumab within 10 weeks, ustekinumab within 6 months);\n10. Patients with prior use of baricitinib or ADA;\n11. Complications of intestinal BS such as symptomatic stenosis, short bowel syndrome, intestinal fistula, or suspected intra-abdominal abscess; potential need for surgery or situations not conducive to DAIBD and efficacy assessment; any form of intestinal resection or other abdominal surgery within 6 months before baseline; presence of a functioning (i.e., patent) stoma or ostomy;\n12. Patients requiring parenteral nutrition due to disease severity;\n13. Pregnant, lactating, or planning pregnancy soon;\n14. Patients unwilling or unable to comply with regular visits;\n15. History of severe thrombotic events or chronic cardiovascular events.","locations":[{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jinjing Liu, M.D.","phone":"86-10-69151188","email":"pumch_followup@126.com"},{"name":"Wenjie Zheng, M.D.","phone":"","email":""}],"primaryOutcomes":["Proportion of patients with marked improvement (MI) at week 24 of follow-up"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing Baricitinib for Behcet Syndrome, Intestinal Type","inPlainEnglish":"This study aims to conduct a randomly assigned controlled trial to compare the how well it works and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS). The objective is to demonstrate if Baricitinib is non-inferior to ADA in controlling BS inflammation, reducing BS recurrence， alleviating gastrointestinal symptoms and promoting intestinal mucosal healing.","whoItsFor":["Ages 18 Years to 65 Years","Patients have a DAIBD score ≥ 40 points or intestinal symptom score ≥ 3 points at baseline;","Endoscopic examination conducted within 60 days before inclusion suggests active intestinal ulcers;","Currently steroid dose ≤ 30 mg prednisolone equivalent, stabilized for ≥ 2 weeks, and/or stabilized immunomodulator dose for ≥ 4 weeks;"],"whoShouldSkip":["Diagnosis of other diseases such as Crohn's disease, ulcerative colitis, lymphoma, etc.;","Other active organ damage related to BS requires intensified immunosuppressive therapy, including aneurysms, uveitis, and substantial involvement of the central nervous system; skin lesions and joint involvement can be included;","Severe organ dysfunction including ALT, AST, TBIL levels exceeding twice the upper limit of normal, creatinine levels exceeding 1.5 times the upper limit of normal, white blood cell count \\< 3×10\\^9/L, ANC \\< 2×10\\^9/L, hemoglobin \\< 80g/L, platelets \\< 100×10\\^9/L;","Active infections such as active tuberculosis, active hepatitis B or C, syphilis, chronic Epstein-Barr virus infection, HIV infection, sustained or severe bacterial or viral infections, and history of severe herpes zoster;","Patients with latent tuberculosis must undergo ≥3 weeks of prophylactic anti-tuberculosis treatment before inclusion;","Primary immunodeficiency disease;","History of cancer, or endoscopic intestinal histopathology indicating intraepithelial neoplasia or malignancy, or presence of other malignancies;"],"whatHappens":"If you join, the listed intervention(s) are Baricitinib, or Adalimumab. The registry lists allocation as randomized. This study aims to conduct a randomly assigned controlled trial to compare the how well it works and safety of Baricitinib and Adalimumab (ADA) in the treatment of refractory intestinal Behçet's Syndrome (BS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 56 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.266Z"},{"nctId":"NCT06852365","title":"Combined Oral Contraceptive Pill and Resistance Starch","officialTitle":"Resistant Starch Usage in Polycystic Ovary Syndrome: Impact on Cardiometabolic Dysfunction and the Gut Microbiome (CORS-PCOS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of placebo to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to placebo.","conditions":["Metabolic Syndrome","Polycystic Ovary Syndrome"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"wheat dextrin"},{"type":"DRUG","name":"Oral Contraceptives, Low-Dose"},{"type":"DIETARY_SUPPLEMENT","name":"Maltodextrin"}],"enrollment":100,"startDate":"2025-06-10","completionDate":"2028-04","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Women between ages of 18-40 years with BMI greater than or equal to 25 kg/m² to less than or equal to 48 kg/m² diagnosed with PCOS defined by the Rotterdam criteria based on a history of chronic anovulation (8 or fewer periods), androgen excess \\[defined as total serum testosterone, free testosterone or a FAI greater than or equal to 90% of the upper limit of normal) or hirsutism (Ferriman-Gallwey score greater than 6 for Hispanics/ Black and greater than or equal to 2 for women of Asian descent)\\] and polycystic ovaries as defined by a pelvic ultrasound (20 or more follicles or ovarian vol greater than 10cm3) or elevated AMH.\n2. For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation.\n3. Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS.\n4. Subjects should be willing to avoid pregnancy for the entire duration of the study.\n\nExclusion Criteria:\n\n1. Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause.\n2. Subjects with late onset adrenal hyperplasia\n3. Subjects with history of bariatric surgery\n4. Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies.\n5. Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications).\n6. History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded.\n7. Subjects could not have taken antibiotics for at least 3 months prior to randomization visit.\n8. Subjects with greater than 20 g/day of dietary fiber intake based on pre-screening ASA-24 survey will be excluded.\n9. Subjects with medical conditions that are contraindications to use of OCP and other medical conditions such as:\n\n   1. Type 1 or 2 diabetes\n   2. liver disease or dysfunctional liver (AST/ALT greater than 2x normal or a total bilirubin greater than 2.5 mg/dL)\n   3. renal disease (BUN greater than 30 mg/dL or serum creatinine greater than 1.4 mg/dL)\n   4. severe anemia (hemoglobin less than 10 mg/dL)\n   5. alcohol abuse\n   6. poorly controlled hypertension\n   7. TG greater than 250 mg/dl\n   8. chronic inflammatory conditions such as psoriasis\n   9. history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; known heart disease (New York Heart Association Class II or higher)\n   10. history of cervical carcinoma, endometrial carcinoma, or breast carcinoma, adrenal or ovarian tumor secreting androgens, and Cushing's syndrome -","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anuja Dokras, MD PhD","phone":"215-615-0085","email":"adokras@pennmedicine.upenn.edu"},{"name":"Andrea Morley","phone":"215-615-4202","email":"andrea.morley@pennmedicine.upenn.edu"}],"primaryOutcomes":["Change in LDL-C measure","Change in fasting glucose measure","Change in systolic blood pressure","Change in diastolic blood pressure","Change in BMI","Change in Bifidobacteria abundance measured by quantitative polymerase chain reaction (q-PCR)","Change in Single Chain Fatty Acids (SCFA)"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Phase 2: testing Oral Contraceptives, Low-Dose for Metabolic Syndrome","inPlainEnglish":"This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of dummy treatment (placebo) to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 40 Years","Women only","For women with more regular bleeding patterns, but who are suspected to be experiencing periodic anovulatory bleeding, a midluteal progesterone (P4) level less than 3ng/dL will be evidence of ovulatory dysfunction and qualify as anovulation","Women with only hyperandrogenic PCOS phenotype (hyperandrogenism + one more criteria) will be included to decrease the heterogeneity of the cohort and as metabolic risks are increased in these women compared to normo-androgenic women with PCOS","Subjects should be willing to avoid pregnancy for the entire duration of the study"],"whoShouldSkip":["Subjects with other causes for irregular menses such as pregnancy, lactation, untreated hypothyroidism, untreated hyperprolactinemia and premature menopause","Subjects with late onset adrenal hyperplasia","Subjects with history of bariatric surgery","Those who are unable to comply with the study procedures, for instance due to mental illness, substance abuse, or participation in other studies","Subjects taking medications that affect weight or metabolic parameters (e.g. lipid lowering medications)","History of Crohn's disease and ulcerative colitis as well as current use of probiotics and laxatives are excluded","Subjects could not have taken antibiotics for at least 3 months prior to randomization visit"],"whatHappens":"If you join, the listed intervention(s) are wheat dextrin, Oral Contraceptives, Low-Dose, or Maltodextrin. The registry lists allocation as randomized. This study will enroll women with PCOS to study the effects of first line therapy, oral contraceptive pills, and then either 12 weeks of resistant starch or 12 weeks of dummy treatment (placebo) to explore if resistant starch improves cardiometabolic parameters or impacts gut dysbiosis compared to dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.797Z"},{"nctId":"NCT06856226","title":"Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant","officialTitle":"Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nAfter an allogeneic hematopoietic stem cell transplant (HSCT), the donor genome is found in the recipient s circulation and tissues.\n\nPost-HSCT recipients may receive a medication in which the dosing needs to be adjusted based on genetic variation.\n\nWhile genes in donor genome may influence dosing and administration of some agents, the majority of established gene-drug pairs in pharmacogenetics are related to expression of metabolic or transporting enzymes located in recipients tissues, often the liver.\n\nDetermining which genetic variants influence drug disposition in HSCT recipients is complicated by chimerism in samples that are routinely collected for determining genotype. However, chimerism in tissues is poorly studied in this patient population.\n\nObjectives:\n\nTo determine the most reliable host genomic source for pharmacogenetic testing in participants that have received allogeneic HSCT.\n\nEligibility:\n\nPeople ages 18 years and older who are enrolled on a clinical trial at the NIH Clinical Center under which they will donate or receive an allogeneic HSCT.\n\nDesign:\n\nDNA is collected prior to HSCT and for two years after HSCT.\n\nBlood will be collected and skin fibroblast cell lines will be established prior to HSCT to serve as a reference genome.\n\nBlood, buccal cells, skin, and hair will be monitored for the development of mixed chimerism via detection of short tandem repeats. Liver biopsies will be collected from participants undergoing hepatic surgery.\n\nPharmacoscan arrays will be conducted to determine which samples are useful for pharmacogenetic testing in participants who receive allogeneic HSCT.\n\nA probe drug cocktail will be administered pre- and post-HSCT to determine if transplantation alters the metabolic phenotype of liver enzymes.\n\n...","conditions":["Leukemia","Lymphoma","Hematologic Malignancy"],"keywords":["Allogeneic Transplant","Hematopoietic Cell Transplant","Bone Marrow Transplant","peripheral blood transplant","Chimerism"],"interventions":[{"type":"OTHER","name":"Arm 1"}],"enrollment":88,"startDate":"2026-03-04","completionDate":"2030-12-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Age \\>=18 years\n* Participants must be enrolled on a clinical trial at the NIH Clinical Center (CC) under which they will donate or receive an allogeneic HSCT. The participant and their donor must enroll together to provide a complete set of samples for analysis.\n* Ability of subject to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Donors are not allowed to enroll without a recipient\n* Prior allogeneic HSCT\n* History of psychiatric disorder which may compromise compliance with protocol requirements.\n* Pregnant and lactating individuals","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ashley E Carpenter","phone":"(240) 760-6009","email":"carpentera@mail.nih.gov"},{"name":"Christopher G Kanakry, M.D.","phone":"(240) 760-6171","email":"christopher.kanakry@nih.gov"}],"primaryOutcomes":["To determine the most reliable host genomic source for pharmacogenetic testing in participants that have received allogeneic hematopoietic stem cell transplant (HSCT)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Arm 1 for Leukemia","inPlainEnglish":"Background: After an allogeneic hematopoietic stem cell transplant (HSCT), the donor genome is found in the recipient s circulation and tissues. Post-HSCT recipients may receive a medication in which the dosing needs to be adjusted based on genetic variation.","whoItsFor":["Ages 18 Years to 120 Years","Participants must be enrolled on a clinical trial at the NIH Clinical Center (CC) under which they will donate or receive an allogeneic HSCT. The participant and their donor must enroll together to provide a complete set of samples for analysis"],"whoShouldSkip":["Donors are not allowed to enroll without a recipient","Prior allogeneic HSCT","History of psychiatric disorder which may compromise compliance with protocol requirements","Pregnant and lactating individuals"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 88 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.821Z"},{"nctId":"NCT06857942","title":"A Study to Investigate the Effectiveness of Tirzepatide (LY3298176) Following Initiation of Ixekizumab (LY2439821) in Participants With Moderate-to-Severe Plaque PsO and Obesity or Overweight in Clinical Practice (TOGETHER AMPLIFY-PsO)","officialTitle":"A Phase 4, Prospective, Open-Label, Single Arm Study to Assess the Effectiveness of Tirzepatide After Initiation of Ixekizumab in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight in Clinical Practice","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.\n\nThe study will last up to 12 months.","conditions":["Psoriasis","Overweight or Obesity"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":200,"startDate":"2025-03-19","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)\n* Have body mass index (BMI) of 30 kilograms per meter squared (kg/m²) or greater (obesity) or 27 kg/m² to \\<30 kg/m² (overweight) in the presence of at least 1 weight-related comorbid condition (hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular diseases).\n* Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide.\n* Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening).\n\nExclusion Criteria:\n\n* Have currently received ixekizumab for more than 4 months or less than 2 months.\n* Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide.\n* Are currently enrolled in any other clinical study.\n\nOther exclusions\n\n* Have a known hypersensitivity to tirzepatide or to any of its component.\n* Have a personal or family history of medullary thyroid cancer.\n* Have multiple endocrine neoplasia type 2.\n* Have type I diabetes mellitus.\n* Have a history of chronic or acute pancreatitis at any time before screening (Visit 1).\n* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that requires acute treatment.\n* Have a history of ketoacidosis or hyperosmolar state/coma.\n* Have a history of severe hypoglycemia and hypoglycemia unawareness within the 6 months before screening.\n* Have a history of severe gastrointestinal complications, including gastroparesis, gastroesophageal reflux disease, dyspepsia, chronic nausea/constipation/vomiting.","locations":[{"facility":"Medical Dermatology Specialists","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First OC Dermatology Research Inc","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center For Dermatology Clinical Research, Inc.","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolis Dermatology","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northridge Clinical Trials","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeoClinical Research","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Care Research","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MOORE Clinical Research, Inc. d/b/a TrueBlue Clinical Research","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TruDerm & TruSpa","city":"Wellington","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeast Research Specialists","city":"Douglasville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Research Group, LLC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Indiana Clinical Trials Center, PC","city":"Plainfield","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Equity Medical - Bowling Green","city":"Bowling Green","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology and Skin Cancer Specialists, LLC","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Boston Clinical Partners","city":"Brighton","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David Fivenson, MD, PLC","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Derm Institute of West Michigan","city":"Caledonia","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Cancer and Dermatology Institute - Reno","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stracskin","city":"Portsmouth","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psoriasis Treatment Center of Central New Jersey","city":"East Windsor","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Hoboken","city":"Hoboken","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Equity Medical","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Cary","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions - Huntersville","city":"Huntersville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optima Research - Boardman","city":"Boardman","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Dermatology and Research Center","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Associates of Plymouth Meeting","city":"Plymouth Meeting","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia Dermatology & Aesthetics","city":"Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research - Thompson's Station","city":"Smyrna","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellaire Dermatology Associates","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Modern Research Associates, PLLC","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Clinical Studies","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Institute for Clinical Research","city":"Pflugerville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Dermatology and Laser Specialists","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Clinical Studies","city":"Webster","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tanner Clinic","city":"Layton","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellevue Dermatology Clinic","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) (0,1)","Percentage of Participants Achieving at least 10% Weight Reduction"],"hasResults":false,"conditionSlugs":["obesity","psoriasis"],"drugSlugs":["tirzepatide"],"locationSlugs":["phoenix-arizona","fountain-valley-california","fremont-california","los-angeles-california","northridge-california","hialeah-florida","hollywood-florida","tampa-florida","wellington-florida","douglasville-georgia","indianapolis-indiana","plainfield-indiana","bowling-green-kentucky","rockville-maryland","brighton-massachusetts","ann-arbor-michigan","caledonia-michigan","reno-nevada","portsmouth-new-hampshire","east-windsor-new-jersey","hoboken-new-jersey","new-york-new-york","cary-north-carolina","huntersville-north-carolina","boardman-ohio","portland-oregon","plymouth-meeting-pennsylvania","columbia-south-carolina","smyrna-tennessee","bellaire-texas","dallas-texas","houston-texas","pflugerville-texas","san-antonio-texas","webster-texas","layton-utah","bellevue-washington"],"enrichment":{"headline":"Phase 4: testing Tirzepatide for Psoriasis","inPlainEnglish":"The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.","whoItsFor":["Ages 18 Years to any","Have a diagnosis of moderate-to-severe plaque PsO, as defined by a dermatologist or other experienced clinician treated PsO (for example, allergologist, nurse practitioner or physician assistant)","Must have initiated treatment with ixekizumab for approximately 3 months (± 1 month) prior to decision to add tirzepatide","Must be able to initiate tirzepatide (Day 0) within 30 days of treatment decision (baseline/screening)"],"whoShouldSkip":["Have currently received ixekizumab for more than 4 months or less than 2 months","Have had any exposure to tirzepatide or other glucagon-like peptide-1 receptor agonist (GLP-1 RAs), for example, dulaglutide, liraglutide, or semaglutide","Are currently enrolled in any other clinical study","Have a known hypersensitivity to tirzepatide or to any of its component","Have a personal or family history of medullary thyroid cancer","Have multiple endocrine neoplasia type 2","Have type I diabetes mellitus"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. The main purpose of this study is to assess the effectiveness of adding tirzepatide to ixekizumab therapy in standard clinical practice in participants with moderate-to-severe plaque PsO and obesity or overweight with at least 1 weight-related comorbidity.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 200 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.575Z"},{"nctId":"NCT06859164","title":"Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis","officialTitle":"Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of Utah","sponsorClass":"OTHER","summary":"Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot Randomized Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomized sham-controlled trial (RCT). The influence of psychosocial and psychocognitive factors, changes in analgesic use, and conditions of knee joint cartilage and effusion will similarly be explored to determine their impacts on perceived pain response to GAE.","conditions":["Knee Osteoarthritis","Knee Osteoarthritis (Knee OA)","Knee Osteoarthritis (OA)"],"keywords":["Osteoarthritis","Knee pain","MSK pain","Musculoskeletal Pain","Osteoarthritis of the knee","GAE","Genicular artery embolization","Geniculate artery embolization","MSK embolization","Musculoskeletal Embolization","Embolization","Musculoskeletal","Temporary Embolization"],"interventions":[{"type":"PROCEDURE","name":"Genicular Artery Embolization"},{"type":"DEVICE","name":"Lipiodol"},{"type":"PROCEDURE","name":"Simple angiogram"}],"enrollment":40,"startDate":"2026-07-01","completionDate":"2027-08-31","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 40-80\n* Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)\n* Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale\n* Knee pain \\> 6 months, refractory to conservative non-operative management, and scored ≥ 4 on Visual Analog Scale (VAS) (e.g., rest, activity modification, weight control, bracing, supervised physical therapy, nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, oral opiates, intra-articular hyaluronic acid, PRP, stem cells, and/or oral/injectable corticosteroids)\n* Refusal of intra-articular corticosteroid injection\n\nExclusion Criteria:\n\n* Active malignancy\n* Active infection of the affected knee\n* Corticosteroid injection of the affected knee within 3 months of enrollment\n* Rheumatoid arthritis or other seronegative arthropathy\n* Previous surgery of the affected knee (e.g., meniscus repair, meniscectomy, anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) reconstruction, chondroplasty, microfracture, loose-body removal, synovectomy, lateral release, patellar/quadriceps tendon repair, total or partial knee replacement, osteotomy, cartilage transplant), except diagnostic arthroscopy\n* Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee\n* Pregnancy or expected pregnancy\n* GFR \\< 60 mL/min/1.73 m²\n* Anaphylactic reaction to iodinated contrast\n* Moderate to severe pain in other ipsilateral lower-limb joints (ankle, hip) with VAS \\> 4\n* Body weight \\> 400 lbs (unsafe for angiography)\n* Peripheral arterial disease of the treated extremity (Rutherford Grade 2 or greater)\n* Type 1 diabetes mellitus\n* Long-acting corticosteroid use within 6 months (3 months for short-acting)\n* History or other evidence of acute kidney injury (AKI)\n* History of reaction to contrast media, bronchial asthma, or allergic disorders\n* History of hypersensitivity to gadolinium-based contrast agents (GBCAs)\n* Chronic widespread generalized pain \\>4 on VAS pain scale, including neuropathic pain\n* Major depressive disorder within 2 years before screening\n* Other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)\n* Suicide attempt or suicidal behavior within 30 days before screening\n* Diagnosis of fibromyalgia\n* Considering total knee replacement in the next year\n* Any other condition, unwillingness, or inability that, in the investigator's opinion, could jeopardize the subject's safety or protocol compliance","locations":[{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Osman Ahmed, MD","phone":"8478124513","email":"osman.ahmed@utah.edu"},{"name":"Layth Alkhani, BS","phone":"","email":"layth.alkhani@utah.edu"}],"primaryOutcomes":["Reduction in KOOS pain subscore"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["salt-lake-city-utah"],"enrichment":{"headline":"Phase 2: Genicular Artery Embolization for Knee Osteoarthritis","inPlainEnglish":"Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot randomly assigned Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore. Additionally, this study aims to determine the magnitude of difference in pain response between GAE and sham to adequately power a larger, more definitive randomly assigned sham-controlled trial (RCT).","whoItsFor":["Ages 40 Years to 80 Years","Patients aged 40-80","Bilateral or unilateral knee pain attributed to osteoarthritis (treat the knee with greater pain-if equal, patient chooses)","Grade 2-4 osteoarthritis on standing weight-bearing knee radiographs per the Kellgren-Lawrence grading scale","Refusal of intra-articular corticosteroid injection"],"whoShouldSkip":["Active infection of the affected knee","Corticosteroid injection of the affected knee within 3 months of enrollment","Rheumatoid arthritis or other seronegative arthropathy","Grade 0-1 osteoarthritis per Kellgren-Lawrence grading scale of the affected knee","Pregnancy or expected pregnancy","GFR \\< 60 mL/min/1.73 m²","Anaphylactic reaction to iodinated contrast"],"whatHappens":"If you join, the listed intervention(s) are Genicular Artery Embolization, Lipiodol, or Simple angiogram. The registry lists allocation as randomized. Genicular Artery Embolization for Reducing Pain in Symptomatic Knee Osteoarthritis: A Pilot randomly assigned Sham-Controlled Study (SHAM-PAIN) is a NIH-NIAMS funded project designed to assess enrollment feasibility and detect any differences between GAE and a similar sham intervention in reducing KOA-related pain at 3 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscore.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Salt Lake City. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.522Z"},{"nctId":"NCT06860607","title":"Environment and Alcohol: A Pilot Study","officialTitle":"Environment and Alcohol: A Pilot Study","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute on Drug Abuse (NIDA)","sponsorClass":"NIH","summary":"Background:\n\nAlcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication. Some people with AUD may also benefit from behavioral and lifestyle changes.\n\nObjective:\n\nTo evaluate the effects of different activities and environments on drinking behaviors and mental health in people with AUD.\n\nEligibility:\n\nPeople aged 21 years and older with AUD.\n\nDesign:\n\nParticipants will have up to 10 study visits in Baltimore.\n\nParticipants will have a baseline visit. They will have a physical exam with blood and urine tests. They will have a breath test for alcohol and a test that measures body composition. They will answer questions about their alcohol and substance use; mental and physical health; mood and anxiety; and sleep quality.\n\nParticipants will download an app called MetricWire. The app will send 3 sets of questions to be answered at different times throughout the day.\n\nThe study visits will include 2 stages:\n\n1. Active stage. On these visits, participants will use a virtual reality system called the Meta Quest Pro (MQP) as they choose. Then they may choose among video games, puzzles, books, crafts, and other activities.. These sessions will last for 3 hours.\n2. Passive stage. On these visits, participants will watch videos selected by the research team. These sessions will last for 3 hours.\n\nOn the last visit of each stage, participants will sit in a room that looks like a bar. They will answer questions about their cravings, their urge to drink, and how many drinks they would buy. Participants will be served 1 drink containing alcohol. They will be asked about their cravings and subjective effects of alcohol after drinking it.","conditions":["Alcohol Use Disorder"],"keywords":["Alcohol Use Disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption"}],"enrollment":44,"startDate":"2026-11-15","completionDate":"2027-03-01","sex":"ALL","minAge":"21 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo meet eligibility for this study, participants must meet all the following criteria:\n\n1. At least 21 years old\n2. Owns a cellular device (\"smart phone\") and is willing to download the EMA application and use it to answer the study questionnaires\n3. Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))\n4. Self-reported drinking, according to alcohol Timeline Follow-Back (TLFB), of \\> 7 drinks per week for females or \\> 14 drinks per week for males, on average, during the 28-day period prior to screening + at least four days with \\> 3 drinks for females or \\> 4 drinks for males during the 28-day period prior to screening\n5. Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\< 10\n6. If a female of childbearing potential: not pregnant or breastfeeding, no intention to become pregnant during the study duration, and agrees to use a highly effective contraception method to prevent pregnancy for the entire study duration. Highly effective contraception methods will be determined by the MAI or designee.\n\nEXCLUSION CRITERIA:\n\nAny individual who meets any of the following criteria will be excluded from this study:\n\n1. Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD\n2. Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively.\n3. Known history of clinically significant cybersickness.\n4. Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant\n5. Unable to speak, read, write, and understand English\n\nJustification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study.","locations":[{"facility":"National Institute on Drug Abuse","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ryan E Tyler","phone":"(240) 789-0347","email":"ryan.tyler@nih.gov"},{"name":"Lorenzo Leggio, M.D.","phone":"(667) 312-5188","email":"lorenzo.leggio@nih.gov"}],"primaryOutcomes":["Evaluate the effects of EE on alcohol consumption"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1: Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption for Alcohol Use Disorder","inPlainEnglish":"Background: Alcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year. AUD treatment often includes therapy and medication.","whoItsFor":["Ages 21 Years to 100 Years","To meet eligibility for this study, participants must meet all the following criteria:","At least 21 years old","Owns a cellular device (\"smart phone\") and is willing to download the EMA application and use it to answer the study questionnaires","Diagnosis of alcohol use disorder (minimum of 2 DSM-5 criteria on a valid diagnostic tool, e.g., Mini-International Neuropsychiatric Interview (MINI) or the Structured Clinical Interview for DSM Disorders (SCID))","Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score \\< 10"],"whoShouldSkip":["Any individual who meets any of the following criteria will be excluded from this study:","Current use of FDA-approved pharmacotherapy for AUD (or of a medication intended as an off-label use to treat AUD as determined by the MAI), or currently seeking treatment for AUD","Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively","Known history of clinically significant cybersickness","Any other reason or clinical condition that the Investigators judge would interfere with study participation and/or be unsafe for a participant","Unable to speak, read, write, and understand English","Justification: Many of the assessments have only been validated in English, and therefore, a non-English translation would jeopardize the scientific integrity of the study"],"whatHappens":"If you join, the listed intervention(s) are Evaluate the effects of Environmental Enrichment (EE) on alcohol consumption. The registry lists allocation as na. Background: Alcohol use disorder (AUD) is a chronic disease that causes more than 140,000 US deaths each year.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 44 people at Baltimore. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.262Z"},{"nctId":"NCT06860763","title":"Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.","officialTitle":"Clinical Study on Acupuncture Treatment for Attention Deficit Hyperactivity Disorder.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The Third Affiliated Hospital of Beijing University of Chinese Medicine","sponsorClass":"OTHER","summary":"This study aims to evaluate the efficacy of acupuncture as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-12 years. Using a mixed-methods approach, the research will triangulate data from acupoint data mining, treatment outcomes assessment, and patient perspectives to provide a comprehensive analysis of acupuncture's potential therapeutic benefits for ADHD.\n\nThis prospective cohort study will recruit children diagnosed with ADHD, assigning them to receive either acupuncture combined with traditional Chinese herbal treatment or herbal treatment alone. Quantitative assessments using the the SNAP-IV, Conners 3-P, BRIEF-2, PedsQL™ 4.0 Generic Core Scales, PSQI and CGI that will be complemented by qualitative interviews to capture nuanced patient experiences and treatment outcomes.\n\nThe study will span 12 months, commencing on March 1st, 2025 with an expected completion by February 28th, 2026. By integrating quantitative assessments with qualitative insights, it aims to provide comprehensive evidence on acupuncture's role in ADHD management. Findings may inform clinical guidelines and enhance patient-centered care approaches.","conditions":["Acupuncture","ADHD - Attention Deficit Disorder With Hyperactivity","Children","Interview","Executive Functioning","Quality of Life (QOL)"],"keywords":["Acupuncture","ADHD","Executive functioning","Interview","TCM","PedsQL"],"interventions":[{"type":"DRUG","name":"Chinese herbal medicine"},{"type":"DEVICE","name":"Acupuncture"}],"enrollment":120,"startDate":"2024-10-15","completionDate":"2026-12-15","sex":"ALL","minAge":"6 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatients will be considered for enrolment if they meet the criteria of:\n\n* A confirmed diagnosis of ADHD based on the DSM-5 criteria for ADHD (Western medical diagnosis) and in accordance with the ADHD Chinese Medicine Clinical Trial Design and Evaluation Technical Guidelines.\n* Aged between 6 and 12 years.\n* No use of any other pharmacological treatments (both Western and traditional Chinese medicine) within the two weeks prior to the start of the study.\n* An IQ score of greater than 80, as determined by the Raven's Progressive Matrices test.\n* The participant has not participated in any other clinical trials.\n\nExclusion Criteria:\n\nPatients will be excluded from the study if they meet any of the following criteria:\n\n* Do not meet the inclusion criteria\n* Have comorbid psychiatric disorders, severe medical or psychiatric conditions that may interfere with the study (e.g., epilepsy, severe anxiety), pervasive developmental disorders, intellectual disability, or a history of suicidal or self-harming behavior\n* Have participated in any other drug clinical trials within the past 3 months.\n* Have severe comorbid conditions such as cardiovascular, hepatic, renal, or hematologic diseases.\n* Have any other conditions that the researchers believe may interfere with the assessment of treatment efficacy or safety.","locations":[{"facility":"Pediatrics Outpatient Department of the Third Affiliated Hospital of Beijing University of Chinese Medicine","city":"Beijing","state":"Chaoyang District","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tananan Sangwanit, Ph.D.student","phone":"+8615201052193","email":"tananan.sangwanit@gmail.com"},{"name":"Xue Bai, Ph.D.","phone":"+8618810212203","email":"baixue8912@163.com"}],"primaryOutcomes":["SNAP-IV"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Chinese herbal medicine for Acupuncture","inPlainEnglish":"This study aims to measure the how well it works of acupuncture as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-12 years. Using a mixed-methods approach, the research will triangulate data from acupoint data mining, treatment outcomes assessment, and patient perspectives to provide a comprehensive analysis of acupuncture's potential therapeutic benefits for ADHD.","whoItsFor":["Ages 6 Years to 12 Years","Patients will be considered for enrolment if they meet the criteria of:","A confirmed diagnosis of ADHD based on the DSM-5 criteria for ADHD (Western medical diagnosis) and in accordance with the ADHD Chinese Medicine Clinical Trial Design and Evaluation Technical Guidelines","Aged between 6 and 12 years","No use of any other pharmacological treatments (both Western and traditional Chinese medicine) within the two weeks prior to the start of the study","An IQ score of greater than 80, as determined by the Raven's Progressive Matrices test","The participant has not participated in any other clinical trials"],"whoShouldSkip":["Patients will be excluded from the study if they meet any of the following criteria:","Do not meet the who can join","Have comorbid psychiatric disorders, severe medical or psychiatric conditions that may interfere with the study (e.g., epilepsy, severe anxiety), pervasive developmental disorders, intellectual disability, or a history of suicidal or self-harming behavior","Have participated in any other drug clinical trials within the past 3 months","Have severe comorbid conditions such as cardiovascular, hepatic, renal, or hematologic diseases","Have any other conditions that the researchers believe may interfere with the assessment of treatment how well it works or safety"],"whatHappens":"If you join, the listed intervention(s) are Chinese herbal medicine, or Acupuncture. The registry lists allocation as randomized. This study aims to measure the how well it works of acupuncture as a treatment for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6-12 years.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Beijing. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.645Z"},{"nctId":"NCT06860867","title":"PerQdisc Traditional Feasibility Trial.","officialTitle":"A Multi-center Traditional Feasibility Trial of the PerQdisc Artificial Implant in Treatment of Single-level Discogenic Back Pain.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Spinal Stabilization Technologies","sponsorClass":"INDUSTRY","summary":"This is a traditional feasibility study (TFS) study to evaluate the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.\n\nAfter a screening period, qualified participants will be enrolled and treated with the PerQdisc. Patients will not be blinded to their treatment. Participants will then complete the safety follow-up period.","conditions":["Discogenic Low Back Pain"],"keywords":[],"interventions":[{"type":"DEVICE","name":"PerQdisc"}],"enrollment":5,"startDate":"2025-01-10","completionDate":"2027-09-30","sex":"ALL","minAge":"22 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Skeletally mature male or female subjects aged 22-70 (inclusive).\n2. Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI.\n3. Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated.\n4. Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.).\n5. Subject has a low back pain VAS ≥40 mm (4 cm).\n6. Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. \\[As measured by the investigator\\]\n7. Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.\n8. Subject has read and understands the IRB approved informed consent document prior to signing and dating the document and before the initiation of any study-related procedures\n9. Subject is appropriate candidate for the PerQdisc surgical approach \\[as defined in the surgical technique guide\\].\n\nExclusion Criteria:\n\n1. Subject has symptomatic degenerative disc disease at more than one lumbar level\n2. Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces.\n3. Subject has had a prior SI-joint fusion.\n4. Subject has a spinal cord stimulator.\n5. Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)\n6. Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n7. Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n8. Subject has spondylolisthesis (antero- or retrolisthesis) in static X-ray ≥3 mm \\[measured via neutral lateral x-ray\\]\n9. Subject has ≥4 mm dynamic spondylolisthesis \\[measured via flexion/extension x-rays\\]\n10. Subject has \\> 20 degree range of motion at the index level \\[measured via flexion/extension x-rays\\]\n11. Subject has a history of any invasive malignancy (except non-melanoma skin cancer) unless treated with curative intent and there have been no clinical signs or symptoms of malignancy for at least 5 years (in particular, spinal tumors).\n12. Subject has an active systemic infection or infection at the operative site.\n13. Subject has evidence of symptomatic facet joint degeneration or disease where the investigator feels the facet is a major contributor to the subject's pain as diagnosed by injection and/or imaging.\n14. Subject has a known allergy to silicone or barium sulfate.\n15. Subject has been diagnosed with fibromyalgia, hepatitis, rheumatoid arthritis, lupus erythematosus, AIDs, ARC, HIV, or an autoimmune disease that affects the musculoskeletal system.\n16. Subject has been diagnosed with Paget's disease, osteomalacia or any other metabolic bone disease.\n17. Subject has current or recent history (defined ≤ 1 year prior to screening) of substance abuse (alcoholism and/or narcotic addiction) using standard medical definitions of DSM-5\n18. Subject has morbid obesity defined as a body mass index (BMI) \\> 40.\n19. Subject participated in an investigational drug or another medical device study within the last 30 days prior to surgery.\n20. Subject has Osteoporosis, defined as a T-score ≤ -2.5.\n\n    1. An existing DEXA is allowed if completed within 6 months of subject surgery.\n    2. For all subjects without an existing DEXA, the SCORE/MORES will be utilized to screen if a DEXA scan is indicated. If SCORE/MORES value ≥ 6, then a DEXA scan is required.\n21. Female subjects who are pregnant or are trying to become pregnant during the course of the trial.\n22. Subject has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n23. Subject belongs to a vulnerable population or has a condition such that his/her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally disabled, prisoner, chronic alcohol/ substance abuser)\n24. Subject is currently receiving worker's compensation or is involved in any litigation for medical negligence, trauma, or worker's compensation.\n25. Subject has lumbar scoliosis \\> 10 degrees at index level.\n26. Subject has a large, rectangular or irregularly shaped Schmorl's node with an associated active inflammatory process (Modic I changes).\n27. Subject has motion of \\< 3 degrees on pre-operative lateral flexion/extension radiographs at index level.\n28. Subject has opioid medication usage \\> 60 MME (morphine milligram equivalent)/day or change in opioid prescription within 60 days of surgery.\n29. Subject has a preoperative VAS right or left leg pain score \\> the preoperative VAS Back score.\n30. Subject has a history of vertebral fractures in the lumbar spine.\n31. Subject has evidence of severe compression of cauda equina.\n32. Subject is on chronic anticoagulation therapy due to a bleeding disorder and is unable to safely stop anticoagulants or has taken anticoagulants within 3 days prior to procedure.\n33. Subject has low back pain (LBP) of non-spinal or unknown etiology.\n34. Subject is unable to undergo X-ray, MRI, or other radiographic assessments, including discography.\n35. Subject has a degenerative muscular or neurological condition that would interfere with evaluation of outcomes, including but not limited to spinal disease (not at index level), Parkinson's disease, amyotrophic lateral sclerosis (ALS), or multiple sclerosis.\n36. Subject has, in the opinion of the investigator, a behavioral, cognitive, social or medical problem that may interfere with the assessment of the safety or effectiveness of the device.\n37. In the opinion of the investigator the subject has a major psychiatric disorder that may interfere with the assessment of the safety or effectiveness of the device.\n38. Subject has myelopathy.\n39. Subject has primarily leg pain with associated nerve root compression, in the opinion of the investigator.\n40. Subject has an annular defect greater than 6mm that extends from the interior of the disc to the outer margin of the annulus as evaluated on MRI.","locations":[{"facility":"Hope Research Institute","city":"Glendale","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"The CORE Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOPE Research Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"HonorHealth Research & Innovation Institute","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axis Spine Center","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana Spine Group","city":"Carmel","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spine Institute of Louisiana","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SonoSpine","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Molly Bond","phone":"1-800-484-1588","email":"clinical@sstspine.com"}],"primaryOutcomes":["Clinical Composite Success"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["glendale-arizona","phoenix-arizona","scottsdale-arizona","miami-florida","coeur-dalene-idaho","carmel-indiana","shreveport-louisiana","oklahoma-city-oklahoma"],"enrichment":{"headline":"Not a traditional drug phase: PerQdisc for Discogenic Low Back Pain","inPlainEnglish":"This is a traditional feasibility study (TFS) study to measure the safety and effectiveness of the PerQdisc. The study is prospective, multicenter, and open label.","whoItsFor":["Ages 22 Years to 70 Years","Skeletally mature male or female subjects aged 22-70 (inclusive)","Subject has a primary diagnosis of single level discogenic back pain caused by degenerative disc disease (L1 to L5) identified via MRI","Subject has an intact annulus (as determined by MRI) and endplates (as determined by MRI and X-ray) at the level to be treated","Subject must have failed to respond to a minimum of 6 months of conservative treatment for their back pain (e.g., physical therapy, medications, injections, ablations, lifestyle changes, etc.)","Subject has a low back pain VAS ≥40 mm (4 cm)","Subject has adequate disc height (≥6mm measured at the center of the disc) at the level to be treated. \\[As measured by the investigator\\]","Subject is psychosocially, mentally and physically able and willing to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms"],"whoShouldSkip":["Subject has symptomatic degenerative disc disease at more than one lumbar level","Subject has had a prior spinal fusion in the lumbar or thoracic intervertebral spaces","Subject has had a prior SI-joint fusion","Subject has a spinal cord stimulator","Subject has had any prior lumbar spine surgery (instrumented or non-instrumented)","Subject has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion","Subject has congenital moderate or severe spinal stenosis or epidural lipomatosis"],"whatHappens":"If you join, the listed intervention(s) are PerQdisc. The registry lists allocation as na. This is a traditional feasibility study (TFS) study to measure the safety and effectiveness of the PerQdisc.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 5 people at 9 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.837Z"},{"nctId":"NCT06862206","title":"A Multicentre, Single Arm, Non-interventional, Real-world Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China","officialTitle":"A Multicentre, Single Arm, Non-interventional, Real-world Study to Assess Demographic Characteristics and Patient Reported Outcomes in Patients With Severe Eosinophilic Asthma Treated With Benralizumab in China","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic efficacy of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China. This study will also describe the physician-reported reasons for discontinuation and switching of benralizumab therapy.","conditions":["Severe Eosinophilic Asthma"],"keywords":["asthma"],"interventions":[{"type":"DRUG","name":"benralizumab"}],"enrollment":700,"startDate":"2025-07-11","completionDate":"2028-01-31","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria\n\nPatients are eligible for inclusion only if all of the following criteria are met:\n\n* Aged ≥12 years at the time of signing the informed consent form.\n* Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician.\n* For the patients who had received benralizumab prior to enrolment, the interval between the Index date and the date of enrolment must \\<=4 weeks;\n* ACQ-6 score within 7 days prior to index date is required.\n* Patients must have a current prescription for benralizumab with planned initiation of therapy.\n* Participating patients and/or their legally authorized representative must provide signed and dated written informed consent form prior to any study specific procedures.\n\nExclusion criteria\n\nPatients should not be enrolled if any of the following exclusion criteria are met:\n\n1. Patients currently participating in any other interventional clinical trial.\n2. Known history of allergy or reaction to any component of benralizumab.\n3. Malignancy of any kind.\n4. Pregnant, breast-feeding or intending to become pregnant during the study period","locations":[{"facility":"Research Site","city":"Anning","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Binzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangdong","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jiaxing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinhua","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jining","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kunshan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Linyi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mianyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanbu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ningbo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanxi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Suining","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Weifang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuxi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xiamen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhangjiagang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhengzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhenjiang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["asthma control questionnaire"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["anning-china","beijing-china","binzhou-china","changzhou-china","fenyang-china","guangdong-china","guangzhou-china","hangzhou-china","hefei-china","huzhou-china","jiaxing-china","jinan-china","jinhua-china","jining-china","jiyuan-china","kunshan-china","linyi-china","mianyang-china","nanbu-china","nanchang-china","nanjing-china","ningbo-china","shanghai-china","shanxi-china","shenzhen-china","shijiazhuang-china","suining-china","taiyuan-china","weifang-china","wuhan-china","wuxi-china","xian-china","xiamen-china","zhangjiagang-china","zhengzhou-china","zhenjiang-china"],"enrichment":{"headline":"Not a traditional drug phase: testing benralizumab for Severe Eosinophilic Asthma","inPlainEnglish":"The objective of this study is to collect empirical data that elucidates the clinical profile and therapeutic how well it works of benralizumab among the patients aged 12 years and above, with severe eosinophilic asthma. The study will focus on the early treatment response, treatment outcomes and the change in asthma control of benralizumab therapy in a real-world setting in China.","whoItsFor":["Ages 12 Years to any","Patients are eligible for inclusion only if all of the following criteria are met:","Patients with severe eosinophilic asthma prescribed with benralizumab at the discretion of the clinician","For the patients who had received benralizumab prior to enrolment, the interval between the Index date and the date of enrolment must \\<=4 weeks;","ACQ-6 score within 7 days prior to index date is required","Patients must have a current prescription for benralizumab with planned initiation of therapy"],"whoShouldSkip":["Patients should not be enrolled if any of the following"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 700 people at 36 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.341Z"},{"nctId":"NCT06865105","title":"Study of Targeted Therapies for the Treatment of Adult Participants With Active Psoriatic Arthritis","officialTitle":"A Phase 2 Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Active Psoriatic Arthritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. This study will evaluate the efficacy and safety of targeted therapies through a series of substudies, for the treatment of active psoriatic arthritis and to assess the changes in disease symptoms.\n\nThe therapies being assessed in this study are risankizumab, lutikizumab, ABBV-701, and ABBV-547. In Substudy 1, participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: lutikizumab monotherapy, risankizumab monotherapy or a combination therapy of lutikizumab and risankizumab. In Substudy 2, participants will be randomized in a 1:1:1 ratio to one of the three treatment arms: ABBV-701 monotherapy, risankizumab monotherapy, or a combination therapy of ABBV-701 and risankizumab. In Substudy 3, participants will be randomized in a 1:1:1 ratio to one of three doses of ABBV-547. Around 300 participants will be enrolled in the study at approximately 110 sites worldwide.","conditions":["Psoriatic Arthritis"],"keywords":["Psoriatic Arthritis","Risankizumab","Lutikizumab","ABBV-701","ABBV-547","Appaloosa"],"interventions":[{"type":"DRUG","name":"Lutikizumab"},{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"ABBV-701"},{"type":"DRUG","name":"ABBV-547"}],"enrollment":300,"startDate":"2025-04-11","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is willing and able to comply with procedures required in the Master Protocol and relevant, actively enrolling substudies.\n* Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit.\n* Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline Visit.\n* Participant has active plaque PsO, with at least one psoriatic plaque of \\>= 2 cm diameter or nail changes consistent with PsO at Screening Visit.\n* Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA\n\nExclusion Criteria:\n\n* Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation).\n* Participants with the following active, chronic, or recurring infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)\n* Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO.\n* History of fibromyalgia, any arthritis with onset prior to age 17 years, or current diagnosis of inflammatory joint disease other than psoriatic arthritis (PsA) (including but not limited to rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma, polymyositis, dermatomyositis, systemic lupus erythematosus).","locations":[{"facility":"Newport Huntington Medical Group /ID# 272764","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Advanced Rheumatology And Arthritis Center - Avon Park /ID# 273085","city":"Avon Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Of West Florida - Phase I Unit /ID# 273198","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HMD Research LLC /ID# 273086","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Broward Rheumatology Associates /ID# 272892","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 273199","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine - Northwestern Memorial Hospital /ID# 275469","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinic Of Dr. Robert Hozman/Clinical Investigation Specialists, Inc /ID# 272879","city":"Skokie","state":"Illinois","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Willow Rheumatology and Wellness /ID# 277354","city":"Willowbrook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klein & Associates /ID# 272829","city":"Cumberland","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Medical Center /ID# 272702","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paramount Medical Research and Consulting /ID# 272757","city":"Middleburg Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altoona Center For Clinical Research /ID# 272593","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Ramesh C. Gupta /ID# 272897","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research - West Gate /ID# 272765","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis and Rheumatology Research Institute - Frisco /ID# 277306","city":"Frisco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research - Houston /ID# 272754","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research, LLC /ID# 272901","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research - Tomball /ID# 272760","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universite De Sherbrooke - Hotel-Dieu Hospital /ID# 273715","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Recherche Musculo-Squelettique /ID# 274397","city":"Trois-Rivières","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr. Latha Naik Medical Professional Corporation /ID# 272803","city":"Saskatoon","state":"Saskatchewan","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revmatologie /ID# 272367","city":"Brno","state":"Brno-mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"L.K.N. Arthrocentrum /ID# 272366","city":"Hlučín","state":"Moravian-Silesian Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Plus Research /ID# 272363","city":"Uherské Hradiště","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"PV Medical Services /ID# 272368","city":"Zlín","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 272771","city":"Nice","state":"Alpes-Maritimes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Infirmerie Protestante De Lyon /ID# 273731","city":"Caluire-et-Cuire","state":"Auvergne-Rhône-Alpes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Regional Universitaire De Tours - Hopital Trousseau /ID# 272762","city":"Chambray-lès-Tours","state":"Indre-et-Loire","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Regional d Orleans - Hopital de la Source /ID# 272877","city":"Orléans","state":"Loiret","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Chu Bordeaux - Hopital Pellegrin /ID# 273390","city":"Bordeaux","state":"New Aquitaine","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Borsod-Abauj-Zemplen Varmegyei Kozponti Korhaz es Egyetemi Oktatokorhaz /ID# 272572","city":"Miskolc","state":"Borsod-Abauj Zemplen county","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complex Rendelo Med Zrt. /ID# 272570","city":"Székesfehérvár","state":"Fejér","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vital-Medicina /ID# 272855","city":"Veszprém","state":"Fejér","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem Reumatologiai es Immunologiai Klinika /ID# 273195","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revita Reumatologiai Rendelo (Revita Kft.) /ID# 272857","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medicover Integrated Clinical Services - Bydgoszcz (SMO/Network/Consortium) /ID# 273297","city":"Bydgoszcz","state":"Kuyavian-Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCBK S.C. Iwona Czajkowska Anna Podrazka-Szczepaniak /ID# 273305","city":"Pruszków","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Reuma Park /ID# 273301","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osteo Medic s.c. Artur Racewicz Jerzy Supronik /ID# 273304","city":"Bialystok","state":"Podlaskie Voivodeship","country":"Poland","status":"COMPLETED","lat":null,"lon":null},{"facility":"Centrum Kliniczno-Badawcze J.Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka /ID# 273306","city":"Elblag","state":"Warmian-Masurian Voivodeship","country":"Poland","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response","Number of Participants With Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["risankizumab"],"locationSlugs":["huntington-beach-california","avon-park-florida","clearwater-florida","orlando-florida","tamarac-florida","tampa-florida","chicago-illinois","skokie-illinois","willowbrook-illinois","cumberland-maryland","lebanon-new-hampshire","middleburg-heights-ohio","duncansville-pennsylvania","memphis-tennessee","austin-texas","frisco-texas","houston-texas","san-antonio-texas","tomball-texas","sherbrooke-canada","trois-rivi-res-canada","saskatoon-canada","brno-czechia","hlu-n-czechia","uhersk-hradi-t-czechia","zl-n-czechia","nice-france","caluire-et-cuire-france","chambray-l-s-tours-france","orl-ans-france","bordeaux-france","miskolc-hungary","sz-kesfeh-rv-r-hungary","veszpr-m-hungary","budapest-hungary","bydgoszcz-poland","pruszk-w-poland","warsaw-poland","bialystok-poland","elblag-poland"],"enrichment":{"headline":"Phase 2: testing Lutikizumab for Psoriatic Arthritis","inPlainEnglish":"Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time.","whoItsFor":["Ages 18 Years to any","Participant is willing and able to comply with procedures required in the Master Protocol and relevant, actively enrolling substudies","Participant has a documented clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for Psoriatic Arthritis (CASPAR) at Screening Visit","Participant has active disease defined as greater than or equal to 3 tender joints (based on 68 joint count) and greater than or equal to 3 swollen joints (based on 66 joint count) at both the Screening Visit and Baseline Visit","Participant has active plaque PsO, with at least one psoriatic plaque of \\>= 2 cm diameter or nail changes consistent with PsO at Screening Visit","Participant must demonstrate intolerance or inadequate response to 1 to 2 targeted therapies (biologic or targeted synthetic disease-modifying antirheumatic drugs) approved for the treatment of PsA"],"whoShouldSkip":["Participants who have had major surgery performed within 12 weeks prior to randomization or plan to have a major surgery during conduct of the study (e.g., aneurysm removal, stomach ligation)","Participants with the following active, chronic, or recurring infections: Are infected with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus(HCV) infection, active tuberculosis(TB)","Active skin disease other than psoriasis (PsO) which could interfere with the assessment of PsO"],"whatHappens":"If you join, the listed intervention(s) are Lutikizumab, Risankizumab, or ABBV-701. The registry lists allocation as randomized. Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 300 people at 41 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.570Z"},{"nctId":"NCT06865885","title":"LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering","officialTitle":"Study of Optimal LDL-C Value Enhancement With Inclisiran in Patients With Multiple Comorbidities in Which There Are Drug-Drug Interactions Limiting LDL-C Lowering","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"Polypharmacy and drug-drug interactions often limit statin optimization, including in a population of patients prescribed cytochrome P3A4 inhibitors such as, immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk.\n\nThere is an unmet clinical need to improve LDL levels in this vulnerable patient population, which faces increased CV risk due to underlying conditions that also contribute to polypharmacy and multiple drug-drug interactions. This study is a randomized, open-label trial evaluating subcutaneous inclisiran plus standard of care for LDL-C lowering in high-risk primary prevention patients with multiple comorbidities (e.g., type II diabetes, liver disease, chronic kidney disease, autoimmune disease, solid-organ transplant, etc.) who are taking five or more medications in which drug-drug interactions may prevent optimization of statin therapy.","conditions":["Drug Interactions","Primary Prevention","Cardiometabolic Syndrome","LDL-Cholersterol Lowering","Polypharmacy"],"keywords":["Statin intolerance","drug drug interaction","inclisiran","LDL-Cholesterol","polypharmacy","multiple comorbidities"],"interventions":[{"type":"DRUG","name":"Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL"}],"enrollment":100,"startDate":"2025-04-02","completionDate":"2028-06-01","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nTo be eligible to participate in this study, individuals must meet all of the following criteria:\n\n1. Provide signed and dated informed consent form.\n2. Are willing to comply with all study procedures and availability for the duration of the study including the potential randomization to injections, as stated by the participant and assessed by study staff.\n3. Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves.\n4. Take 5 or more medications at the time of enrollment (any type of medication). This includes prescription drugs, as well as over-the-counter drugs or supplements recommended by a healthcare provider, in line with the WHO definition of polypharmacy.\n5. Meet at least one of criteria a, b, or c:\n\n   1. Elevated 10-year ASCVD risk score ≥7.5% based on the ACC/AHA Pooled Cohort ASCVD Risk Estimator Plus tool OR PREVENT-ASCVD 10-Year Risk Estimate ≥ 10% (https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) Or\n   2. Evidence of subclinical atherosclerosis:\n\n      * calcification in any vascular bed, including coronary arteries, aorta\n      * calcification of cardiac valves\n      * breast calcification\n      * carotid plaque that is not hemodynamically significant Or\n   3. Type II diabetes with HbA1c less than 8.5.\n6. Take maximally tolerated dose of statin therapy (for patients that have documented statin intolerance or contraindication, this can be no statin) and have suboptimal LDL levels (LDL ≥ 70 mg/dL or non-HDL ≥ 100 mg/dL based on current treatment guidelines).\n7. Are on stable lipid-lowering therapy for at least 4 weeks prior to screening. Patients can also take other non-PCSK9i lipid-lowering therapies, such as ezetimibe, bempedoic acid, icosapent ethyl, and fibrates.\n8. May have potential drug-drug interactions that may limit statin dose or up-titration.\n9. Agree to adhere to lifestyle considerations (see Section 5.3) throughout study duration.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria will be excluded from participation in this study:\n\n1. Have a history of ASCVD, defined as history of myocardial infarction, atherosclerotic ischemic stroke, transient ischemic attack (TIA) of atherosclerotic ischemic origin, coronary artery bypass graft (CABG), coronary/carotid/peripheral artery/aortic stent for atherosclerotic disease, or peripheral artery disease diagnosed via imaging or ankle-brachial index).\n\n   * For heart transplant recipients, history of myocardial infarction, CABG, or coronary artery stenting is only exclusionary after most recent heart transplant.\n   * Non-atherosclerotic ischemic strokes or TIAs identified as cardioembolic or attributed to hypercoagulability or non-atherosclerotic vasculopathy are NOT exclusionary.\n2. Are pregnant, nursing, or trying to conceive.\n3. Are currently taking PCSK9 inhibitors (evolocumab, alirocumab) or are already on inclisiran. If any prior exposure to evolocumab or alirocumab, the last dose should have been at least 12 weeks prior to study enrollment. If any prior exposure to inclisiran, the last dose should have been at least 6 months prior to study enrollment.\n4. Have a coronary artery calcium score ≥ 300 as these patients are considered secondary prevention patients.\n5. Are currently enrolled in medical research judged not to be scientifically or medically compatible with this study as determined at the discretion of the PI.\n6. Have any other medical condition(s) or take any treatment(s) deemed by the investigator to pose a risk to patient safety or interfere with study evaluation, procedures, or completion.","locations":[{"facility":"UC San Diego Altman Clinical and Translational Research Institute","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pam Taub, MD","phone":"858-657-8530","email":"ptaub@health.ucsd.edu"},{"name":"Antoinette S Birs, MD","phone":"5612817745","email":"abirs@health.ucsd.edu"}],"primaryOutcomes":["Change of LDL-Cholesterol"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Phase 4: testing Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL for Drug Interactions","inPlainEnglish":"Polypharmacy and drug-drug interactions often limit statin optimization, including in a population of patients prescribed cytochrome P3A4 inhibitors such as, immunosuppressive agents, protease inhibitors, and antifungals. These patients frequently have autoimmune conditions or rheumatologic disorders that require complex drug regimens and are often on low-dose statin therapy or no statin at all, resulting in suboptimal LDL levels despite increased cardiovascular (CV) risk.","whoItsFor":["Ages 18 Years to 85 Years","To be eligible to participate in this study, individuals must meet all of the following criteria:","Are ≥ 18 and ≤ 85 years of age with the ability to consent for themselves","Take 5 or more medications at the time of enrollment (any type of medication). This includes prescription drugs, as well as over-the-counter drugs or supplements recommended by a healthcare provider, in line with the WHO definition of polypharmacy","Meet at least one of criteria a, b, or c:","Elevated 10-year ASCVD risk score ≥7.5% based on the ACC/AHA Pooled Cohort ASCVD Risk Estimator Plus tool OR PREVENT-ASCVD 10-Year Risk Estimate ≥ 10% (https://tools.acc.org/ASCVD-Risk-Estimator-Plus/#!/calculate/estimate/) Or","Evidence of subclinical atherosclerosis:","calcification in any vascular bed, including coronary arteries, aorta"],"whoShouldSkip":["Individuals who meet any of the following criteria will be excluded from participation in this study:","For heart transplant recipients, history of myocardial infarction, CABG, or coronary artery stenting is only exclusionary after most recent heart transplant","Non-atherosclerotic ischemic strokes or TIAs identified as cardioembolic or attributed to hypercoagulability or non-atherosclerotic vasculopathy are NOT exclusionary","Are pregnant, nursing, or trying to conceive","Have a coronary artery calcium score ≥ 300 as these patients are considered secondary prevention patients","Are currently enrolled in medical research judged not to be scientifically or medically compatible with this study as determined at the discretion of the PI","Have any other medical condition(s) or take any treatment(s) deemed by the investigator to pose a risk to patient safety or interfere with study evaluation, procedures, or completion"],"whatHappens":"If you join, the listed intervention(s) are Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL. The registry lists allocation as randomized. Polypharmacy and drug-drug interactions often limit statin optimization, including in a population of patients prescribed cytochrome P3A4 inhibitors such as, immunosuppressive agents, protease inhibitors, and antifungals.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at La Jolla. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:35.044Z"},{"nctId":"NCT06866106","title":"Well-being in IBS: Strengths and Happiness (WISH) 2.0","officialTitle":"The WISH Intervention for IBS: Feasibility, Preliminary Effects, and Candidate Gut-Brain Mechanisms","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"The purpose of this study is to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled \"WISH,\" compared to an educational control intervention.","conditions":["Irritable Bowel Syndrome"],"keywords":["irritable bowel syndrome","brain-gut behavior therapy","behavioral health intervention","psychological intervention","psychotherapy"],"interventions":[{"type":"BEHAVIORAL","name":"Positive Psychology (PP) Intervention"},{"type":"BEHAVIORAL","name":"Educational Intervention"}],"enrollment":50,"startDate":"2025-10-30","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria.\n* Language and communication: English fluency and access to a phone.\n\nExclusion Criteria:\n\n* Presence of inflammatory bowel disease or other structural/biochemical primary gastrointestinal illness that better explains IBS-like symptoms: As reported by the patient, their physician, and/or documented in the medical record.\n* Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI) or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND).\n* Cognitive impairment: Assessed using a six-item cognitive screen developed for research.\n* Presence of atrial fibrillation or a cardiac pacemaker, or daily use of beta blocking medication: As reported by the patient and/or documented in the medical record.\n* Plans to start or participate in another new behavioral health intervention or psychotherapy during the study period.","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elizabeth N Madva, MD","phone":"617-724-6300","email":"emadva@mgh.harvard.edu"},{"name":"Emmett McGranaghan, BS","phone":"617-643-4489","email":"emcgranaghan@mgb.org"}],"primaryOutcomes":["Proportion of Intervention Sessions Completed by Participants","Ease of Weekly Exercises","Utility of Weekly Exercises"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Positive Psychology (PP) Intervention for Irritable Bowel Syndrome","inPlainEnglish":"This study wants to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled \"WISH,\" compared to an educational control intervention.","whoItsFor":["Ages 18 Years to any","IBS Diagnosis: Adult patients with an IBS diagnosis meeting standardized Rome IV diagnostic criteria","Language and communication: English fluency and access to a phone"],"whoShouldSkip":["Presence of inflammatory bowel disease or other structural/biochemical primary gastrointestinal illness that better explains IBS-like symptoms: As reported by the patient, their physician, and/or documented in the medical record","Severe psychiatric illness: Current manic episode, psychosis, or active substance use disorder diagnosed via the Mini International Neuropsychiatric Interview (MINI) or Diagnostic Interview for Anxiety, Mood, and OCD and Related Neuropsychiatric Disorders (DIAMOND)","Cognitive impairment: Assessed using a six-item cognitive screen developed for research","Presence of atrial fibrillation or a cardiac pacemaker, or daily use of beta blocking medication: As reported by the patient and/or documented in the medical record","Plans to start or participate in another new behavioral health intervention or psychotherapy during the study period"],"whatHappens":"If you join, the listed intervention(s) are Positive Psychology (PP) Intervention, or Educational Intervention. The registry lists allocation as randomized. This study wants to examine the feasibility, acceptability, preliminary effects, and candidate gut-brain mechanisms of an optimized positive psychology (PP) intervention for patients with irritable bowel syndrome (IBS), entitled \"WISH,\" compared to an educational control intervention.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.445Z"},{"nctId":"NCT06867991","title":"Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis","officialTitle":"Safety and Efficacy of Combined B Cell Depleting theRapy And Daratumumab In Autoimmune Encephalitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"The First People's Hospital of Changzhou","sponsorClass":"OTHER","summary":"Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of severe anti-NMDAR autoimmune encephalitis.","conditions":["Anti-N-Methyl-D-Aspartate Receptor Encephalitis"],"keywords":["Anti-N-Methyl-D-Aspartate Receptor Encephalitis","Ofatumumab","Daratumumab","severe autoimmune encephalitis"],"interventions":[{"type":"DRUG","name":"Ofatumumab combined with daratumumab"},{"type":"DRUG","name":"Ofatumumab"},{"type":"DRUG","name":"Repeated intravenous immunoglobulin/plasma exchange therapy"}],"enrollment":200,"startDate":"2024-11-08","completionDate":"2026-11-08","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 12 years and above\n2. Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen\n3. Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment\n4. mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment\n5. Informed consent or guardian signed informed consent\n\nExclusion Criteria:\n\n1. Severe active or chronic infection in the opinion of the investigator.\n2. Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization.\n3. Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug.\n4. Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment.\n5. Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):\n\n   Aspartate aminotransferase (AST) \\> 2.5 × upper limit of normal (ULN)\n\n   Alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n\n   Total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome)\n\n   Platelet count \\< 75,000/μL (or \\< 75 × 109/L)\n\n   Hemoglobin \\< 8 g/dL (or \\< 80 g/L)\n\n   Total white blood cell count \\< 2,500 cells/mm3\n\n   Total immunoglobulins \\< 600 mg/dL\n\n   Absolute neutrophil count \\< 1200 cells/μL\n\n   CD4 T lymphocyte count \\< 300 cells/µL\n\n   Receipt of any experimental B cell depleting agent, unless CD19 B Cell levels have returned to above the lower limit of normal before randomization A history of severe drug allergies or anaphylaxis to two or more foods or drugs (including known sensitivity to acetaminophen/paracetamol, diphenhydramine or equivalent antihistamines, and methylprednisolone or equivalent glucocorticoids).\n\n   A known history of primary immunodeficiency (congenital or acquired) or underlying conditions, such as human immunodeficiency virus (HIV) infection or splenectomy, that predispose the participant to infection.\n\n   Any of the following received within 3 months before randomization Natalizumab (Tysabri®) Cyclosporin Methotrexate Mitoxantrone Cyclophosphamide Azathioprine\n6. Confirmed positive hepatitis B serology (hepatitis B surface antigen and core antigen) and/or positive hepatitis C PCR at screening.\n7. History of cancer, other than ovarian or extraovarian teratoma (also known as dermoid cyst) or germ cell tumor, or cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma. Treatment of squamous cell carcinoma and basal cell carcinoma should have documented successful curative treatment more than 3 months before randomization.\n8. Received any live or attenuated vaccine (inactivated vaccine is acceptable) within 3 weeks before enrollment.\n9. Received BCG vaccine within 1 year before enrollment.","locations":[{"facility":"The First Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Changzhou","city":"Changzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Xie","phone":"+86051968872122","email":"13706121930@163.com"}],"primaryOutcomes":["Time to mRS<=2, i.e. the proportion of patients with mRS scores of 0-2"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["ofatumumab"],"locationSlugs":["zhengzhou-china","changzhou-china"],"enrichment":{"headline":"Phase 3: testing Ofatumumab combined with daratumumab for Anti-N-Methyl-D-Aspartate Receptor Encephalitis","inPlainEnglish":"Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening.","whoItsFor":["Ages 12 Years to any","Aged 12 years and above","Meet the diagnosis of autoimmune encephalitis and the target antigen is a neuronal surface antigen","Have received at least 3 days of 500-1000mg high-dose methylprednisolone impulse treatment and IVIG (0.4g/kg/d for 5 consecutive days) or at least 5 plasma exchange/immunoadsorption or at least 2 times of efgartigimod treatment","mRS ≥ 3 points and neuropsychiatric manifestations inadequate to symptomatic treatment"],"whoShouldSkip":["Severe active or chronic infection in the opinion of the investigator","Concurrently/previously participated in another clinical study involving investigational therapy within 4 weeks or 5 published half-lives of the investigational therapy (whichever is longer) before randomization","Women who are lactating or pregnant, or intend to become pregnant at any time within six months from study enrollment to the last dose of study drug","Known history of allergy or reaction to any component of the investigational drug formulation, or history of allergic reaction after any biological treatment","Any of the following at screening (one repeat test may be performed during the same screening period to confirm results prior to randomization):","Aspartate aminotransferase (AST) \\> 2.5 × upper limit of normal (ULN)","Alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)"],"whatHappens":"If you join, the listed intervention(s) are Ofatumumab combined with daratumumab, Ofatumumab, or Repeated intravenous immunoglobulin/plasma exchange therapy. The registry lists allocation as randomized. Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.274Z"},{"nctId":"NCT06868485","title":"A Study to Assess the Efficacy of WSD0922-FU in Patients With C797S+ Advanced Non-small Cell Lung Cancer","officialTitle":"A Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With First-Line Osimertinib Treatment and Harbor a C797S Mutation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Wayshine Biopharm, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.","conditions":["Non Small Cell Lung Cancer"],"keywords":["C797S","BM","WSD0922-FU","NSCLC","EGFR"],"interventions":[{"type":"DRUG","name":"WSD0922-FU Tablets, Dose level A"},{"type":"DRUG","name":"WSD0922-FU Tablets, Dose level B"}],"enrollment":40,"startDate":"2025-08-18","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling and analyses.\n* Male or female aged ≥18 years old.\n* Histological or cytological confirmation diagnosis of NSCLC.\n* Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy.\n* Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment.\n* Documented EGFR mutation .\n* Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks.\n* At least one lesion, not previously irradiated and not chosen for biopsy during the study.\n* Females should have evidence of non-childbearing potential.\n\nExclusion criteria:\n\n* Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE Grade 1.\n* Symptomatic brain complications that require urgent neurosurgical or medical intervention.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.\n* Past medical history of ILD.\n* Inadequate bone marrow reserve or organ function as demonstrated.\n* Males and females of reproductive potential.\n* Known intracranial hemorrhage which is unrelated to tumor.\n* Seizures requiring a change in anti-epileptic medications.","locations":[{"facility":"Cleveland Clinic Weston Hospital","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Meridian Health-Southern Ocean Medical Center","city":"Manahawkin","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TxO Central/South, Texas Oncology -Central/South Texas","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Provincial Cancer Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wuhan Union Hospital","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Pulmonary Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University Cancer Institute and Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou","city":"Rennes","state":"Ille-et-Vilaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire CHU De Limoges","city":"Limoges","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Bordeaux - Centre Francois Magendie","city":"Pessac","state":"New Aquitaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Francois Baclesse","city":"Caen","state":"Normandy","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Toulon - Hopital Sainte Musse","city":"Toulon","state":"Var","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lily Liu","phone":"951-547-4692","email":"lily.liu@wayshinebiopharm.com"},{"name":"Wei Zhong","phone":"951-547-4692","email":"wei.zhong@wayshinebiopharm.com"}],"primaryOutcomes":["ORR"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["weston-florida","manahawkin-new-jersey","cleveland-ohio","pittsburgh-pennsylvania","austin-texas","fairfax-virginia","fuzhou-china","wuhan-china","shanghai-china","tianjin-china","rennes-france","limoges-france","pessac-france","caen-france","toulon-france"],"enrichment":{"headline":"Phase 2: testing WSD0922-FU Tablets, Dose level A for Non Small Cell Lung Cancer","inPlainEnglish":"This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.","whoItsFor":["Ages 18 Years to any","Male or female aged ≥18 years old","Histological or cytological confirmation diagnosis of NSCLC","Locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy","Evidence of radiological disease progression while on a previous continuous treatment with first-line Osimertinib treatment","Documented EGFR mutation","Eastern Cooperative Oncology Group (ECOG) 0-1 and a minimum life expectancy of 12 weeks","At least one lesion, not previously irradiated and not chosen for biopsy during the study"],"whoShouldSkip":["Any investigational agents or other anticancer drugs from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment","Any unresolved toxicities from prior therapy greater than CTCAE Grade 1","Symptomatic brain complications that require urgent neurosurgical or medical intervention","Any evidence of severe or uncontrolled systemic diseases","Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection","Past medical history of ILD","Inadequate bone marrow reserve or organ function as demonstrated"],"whatHappens":"If you join, the listed intervention(s) are WSD0922-FU Tablets, Dose level A, or WSD0922-FU Tablets, Dose level B. The registry lists allocation as randomized. This is a Phase II, Open Label, Multicenter, Single Arm Study of WSD0922-FU for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with First-Line Osimertinib Treatment and whose Tumors harbor a C797S mutation within the Epidermal Growth Factor Receptor Gene.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.720Z"},{"nctId":"NCT06868641","title":"The TAIL-PrEP Study","officialTitle":"The TAIL-PrEP Study: Acceptability and Feasibility of a Tailored Adherence Intervention for Safe Discontinuation of Long-acting PrEP","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Columbia University","sponsorClass":"OTHER","summary":"The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session. In Aim 2, the study will refine the TAIL-PrEP intervention and implementation strategy based on findings from the pilot study.","conditions":["HIV Infections"],"keywords":["HIV Prevention","PrEP","Cabotegravir","Long-Acting Injectable","Acceptability","Feasibility","Lenacapavir"],"interventions":[{"type":"BEHAVIORAL","name":"TAIL-PrEP for patients discontinuing cab-LA"},{"type":"BEHAVIORAL","name":"TAIL-PrEP for patients considering discontinuing cab-LA"},{"type":"BEHAVIORAL","name":"TAIL-PrEP for patients considering discontinuing LEN"}],"enrollment":30,"startDate":"2026-06-03","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria:\n\n* At least 18 years of age\n* HIV-negative (self-report)\n* Able to speak and read in English\n* Have access to an internet-connected device capable of running the online video conferencing platform\n* Have a private location at which to take online conference calls\n\nParticipants considering discontinuing cab-LA or LEN have the following additional inclusion criteria:\n\n\\- Considering discontinuing cab-LA or LEN\n\nParticipants discontinuing cab-LA have the following additional inclusion criteria:\n\n* Have discontinued cab-LA injections within the last three months\n* Not currently on cab-LA injections\n* Able to receive and send monthly packages\n* The study period will end for patient participants once the monthly blood draw result indicates that cab-LA levels are not detectable (estimated average of 6 months across all patients) or after 6 months of the study, whichever comes first. If at 6 months of study participation, cab-LA levels are still detectable and participants adhered to at least 50% of study activities (self-collecting and mailing monthly blood samples, completing monthly surveys, attending monthly coaching sessions), participants will be invited to participate in the study for an additional 6 months, for a total of up to 12 study visits.","locations":[{"facility":"Columbia University Irving Medical Center / NewYork-Presbyterian Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathrine A Meyers, DrPH","phone":"212 304 6110","email":"kam2157@cumc.columbia.edu"}],"primaryOutcomes":["Acceptability among Patients","Feasibility among Patients"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: TAIL-PrEP for patients discontinuing cab-LA for HIV Infections","inPlainEnglish":"The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions. In Aim 1, the study will pilot test and assess the acceptability and feasibility of the TAIL-PrEP intervention: for participants discontinuing cab-LA, this will consist of monthly cabotegravir drug level monitoring to provide personalized HIV prevention coaching, for participants considering discontinuing cab-LA or LEN, this will consist of a one-time personalized HIV prevention coaching session.","whoItsFor":["Ages 18 Years to any","At least 18 years of age","HIV-negative (self-report)","Able to speak and read in English","Have access to an internet-connected device capable of running the online video conferencing platform","Have a private location at which to take online conference calls","Participants considering discontinuing cab-LA or LEN have the following additional who can join:","\\- Considering discontinuing cab-LA or LEN"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, or TAIL-PrEP for patients considering discontinuing LEN. The registry lists allocation as randomized. The goal of the TAIL-PrEP study is to understand how to support the safe discontinuation of injectable long-acting cabotegravir (cab-LA) and lenacapavir (LEN) while maximizing the public health impact of biomedical HIV prevention interventions.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.398Z"},{"nctId":"NCT06871839","title":"The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease","officialTitle":"The Clinical Study of Synaptic Plasticity-based Lencanumab for the Treatment of Early Alzheimer's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Cuibai Wei，Clinical Professor","sponsorClass":"OTHER","summary":"Alzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families. Early intervention is regarded as an effective strategy to improve clinical symptoms, delay disease progression and maintain current quality of life. The humanized monoclonal antibody lencanemab (Lecanemab) was approved by the U.S. FDA in July 2023 for the treatment of mild cognitive impairment or mild dementia caused by AD, and was officially approved in January 2024 in China. Lencanemab highly targets soluble and insoluble neurotoxic β-amyloid (Aβ) proteins, reducing pathogenic Aβ plaque deposition and preventing its formation in the brains of AD patients, thus reducing neurotoxicity and improving patients' cognitive functions. In addition, lencanumab may also play a neuroprotective role by modulating synaptic plasticity and regulating neural network activity in brain neurons. However, there is a lack of clinical studies to prove this mechanism. In this study, we will enroll consecutive patients with early AD treated with lencanemab infusion as well as those receiving conventional anti-dementia therapy, and comprehensively assess the effects and intrinsic molecular mechanisms of lencanemab on synaptic function and neural networks using magnetic resonance imaging, molecular imaging positron emission tomography (PET), neuropsychological assessment, and analysis of blood cerebrospinal fluid samples.","conditions":["Alzheimer&#39;s Disease","Lecanemab","Functional Magnetic Resonance Imaging"],"keywords":["Alzheimer&#39;s disease","Lecanemab","functional magnetic resonance imaging"],"interventions":[{"type":"DRUG","name":"Lecanemab treatment group"},{"type":"DRUG","name":"Conventional anti-dementia treatment group"}],"enrollment":120,"startDate":"2025-03-10","completionDate":"2026-12-31","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age between 50 and 90 years.\n2. Male or female patients.\n3. Patients with MCI and mild AD.\n4. MMSE score ≥20, CDR overall score of 0.5 or 1.\n5. Amyloid-positive confirmed by Amyloid-PET or CSF.\n6. Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial.\n7. Agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with cognitive impairment due to reasons other than AD.\n2. A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening.\n3. A score of \\>17 on the Hamilton Depression Scale at screening, or any suicidal behavior within 6 months prior to screening, at screening, or at the baseline visit, as well as any psychiatric diagnosis or symptoms that interfere with the study procedure (such as hallucinations, anxiety disorder, or paranoia).\n4. Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study.\n5. A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment.\n6. Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning).\n7. A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening.\n8. Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the placebo treatment group.\n9. Planning to undergo surgery requiring general anesthesia during the study period.\n10. A positive pregnancy test result, lactation, or pregnancy in females at screening or baseline.","locations":[{"facility":"Capital Medical University Xuanwu Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cui bai Wei","phone":"83198319","email":"weicb@xwhosp.org"}],"primaryOutcomes":["Resting-state fMRI brain network metrics (Independent Component Analysis)"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":["lecanemab"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Lecanemab treatment group for Alzheimer&#39;s Disease","inPlainEnglish":"Alzheimer's disease (AD) manifests itself in cognitive decline, impaired ability to perform daily life, and a variety of behavioral and psychiatric symptoms, seriously endangering the health of the elderly. The prevalence and disability rates of AD in China remain high, and the lack of effective treatment options has brought a heavy burden to patients and their families.","whoItsFor":["Ages 50 Years to 90 Years","Age between 50 and 90 years","Male or female patients","Patients with MCI and mild AD","MMSE score ≥20, CDR overall score of 0.5 or 1","Amyloid-positive confirmed by Amyloid-PET or CSF","Have a reliable caregiver to accompany the patient during study visits and supervise the use of study medication during the trial"],"whoShouldSkip":["Patients with cognitive impairment due to reasons other than AD","A history of transient ischemic attack (TIA), stroke, cerebral hemorrhage, or seizure within the 12 months prior to screening","Patients with a bleeding disorder or receiving anticoagulant therapy, as well as any with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine, and cardiovascular system diseases that affect this study","A hypersensitivity reaction to ranucimab or any other ingredient in the injection solution, or to any monoclonal antibody treatment","Contraindications to MRI scanning, including those with a pacemaker/defibrillator or ferromagnetic metal implants (except for skull and cardiac devices approved as safe for MRI scanning)","A known or suspected history of drug or alcohol abuse or dependence within the 2 years prior to screening","Participation in a clinical study involving any therapeutic monoclonal antibody or novel compounds for the treatment of AD within the 6 months prior to screening, unless it can be proven that the subject was in the dummy treatment (placebo) treatment group"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.235Z"},{"nctId":"NCT06872398","title":"Medical Comorbidities in Bipolar Disorder","officialTitle":"Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fondation FondaMental","sponsorClass":"OTHER","summary":"Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6). BIPCOM will be implemented through continuous consultations with stakeholders (scientific and patients' associations, users and families), for ensuring results' acceptability and transferability. The successful implementation of the project will have a significant impact upon the general health of people with BD, eventually leading to lower mortality rates and reduced incidence of severe disabilities, whilst providing reliable methods and tools for patients' stratification and personalized treatments.","conditions":["Psychiatric Disorder"],"keywords":[],"interventions":[{"type":"OTHER","name":"Blood and saliva sampling"}],"enrollment":80,"startDate":"2024-10-11","completionDate":"2025-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Primary diagnosis of BP I, BP II, or BP NOS\n* Have had at least one contact with mental health services in the past year\n* Be aged between 18 and 65 years old\n* Have signed an informed consent\n\nExclusion Criteria:\n\n* Projected move within the next year.\n* Severe psychiatric comorbidities (schizophrenia spectrum disorders).\n* Severe cognitive impairment.\n* Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST.","locations":[{"facility":"France","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ophélia GODIN, PhD","phone":"0149813326","email":"ophelia.godain@fondation-fondamental.org"}],"primaryOutcomes":["Incidence of Metabolic Syndrome (MetS)"],"hasResults":false,"conditionSlugs":["bipolar-disorder"],"drugSlugs":[],"locationSlugs":["cr-teil-france"],"enrichment":{"headline":"Not a traditional drug phase: Blood and saliva sampling for Psychiatric Disorder","inPlainEnglish":"Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6).","whoItsFor":["Ages 18 Years to 65 Years","Primary diagnosis of BP I, BP II, or BP NOS","Have had at least one contact with mental health services in the past year","Be aged between 18 and 65 years old"],"whoShouldSkip":["Projected move within the next year","Severe psychiatric comorbidities (schizophrenia spectrum disorders)","Severe cognitive impairment","Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Créteil. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.746Z"},{"nctId":"NCT06875245","title":"Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals","officialTitle":"Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Faculty Hospital Kralovske Vinohrady","sponsorClass":"OTHER_GOV","summary":"This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks.\n\nPatients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.\n\nPatients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.","conditions":["Wet Age-related Macular Degeneration"],"keywords":["retina","amd","faricimab","macula"],"interventions":[{"type":"DRUG","name":"Faricimab Injection"}],"enrollment":100,"startDate":"2023-03-31","completionDate":"2025-04","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nActive treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA\n\nBCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye\n\npresence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT\n\npatient capable of signing the informed consent\n\nExclusion Criteria:\n\nMyocardial Infarction or Stroke in the last 3 months\n\nPrevious or current conditions of the study eye:\n\n1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye\n2. scar or fibrosis comprising more than 50% of the lesion in the study eye\n3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye\n4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination\n5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment\n6. idiopathic or autoimmune uveitis in the study eye\n7. other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)\n\nk. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination\n\nn. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye\n\no. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit\n\np. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit\n\nq. allergy or hypersensitivity to any component contained in the study drug\n\nr. pregnant or breastfeeding women","locations":[{"facility":"Department of Ophthalmology, Faculty hospital Kralovske Vinohrady","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Martin Pencak, MD","phone":"+420 267 16 3637","email":"martin.pencak@fnkv.cz"},{"name":"Patrik Rajs, MD","phone":"+420 267 16 3637","email":"patrik.rajs@fnkv.cz"}],"primaryOutcomes":["Change in CRT","Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["prague-czechia"],"enrichment":{"headline":"Phase 4: testing Faricimab Injection for Wet Age-related Macular Degeneration","inPlainEnglish":"This is a prospective, randomly assigned study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomly assigned into two groups and followed for 44 to 56 weeks.","whoItsFor":["Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA","BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye","presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT"],"whoShouldSkip":["Myocardial Infarction or Stroke in the last 3 months","Previous or current conditions of the study eye:","subretinal haemorrhage comprising more than 25% of the lesion in the study eye","scar or fibrosis comprising more than 50% of the lesion in the study eye","presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye","total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination","uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment"],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection. The registry lists allocation as randomized. This is a prospective, randomly assigned study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at Prague. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.135Z"},{"nctId":"NCT06877793","title":"Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling","officialTitle":"Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eric R. Henderson","sponsorClass":"OTHER","summary":"Necrotizing soft-tissue infections (NSTIs, a.k.a. \"necrotizing fasciitis\" or \"flesh-eating bacteria\") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ failure, and death. NSTI cases present with non-specific clinical, imaging, and laboratory findings, and standard-of-care techniques for NSTI diagnosis lack sensitivity and specificity, resulting in frequent misdiagnosis and delayed care, which is the single most important predictor of survival. Consequently, the cumulative mortality rate for patients with NSTIs is 20- 30%; a dire need exists for more accurate and rapid detection of NSTIs. Fluorescence-guided surgery is a nascent technology seeking to improve the recognition of anatomical structures and disease processes using fluorescent probes (fluorophores). Indocyanine green (ICG) is an FDA-approved, near-infrared fluorophore with a \\>60-year safety record for vascular perfusion assessment. A distinguishing histological feature of NSTIs is prominent blood vessel thrombosis in affected tissues. Leveraging these pro-thrombotic effects, our study group has demonstrated in a first-in-human study (NCT04839302) that intravenous administration of ICG and immediate fluorescence imaging reveals prominent signal deficits in NSTI-positive tissues that differentiate significantly with increased signal seen with more common-and less virulent-infections such as cellulitis. We seek now to evaluate this imaging technique on a broader scale and determine if our findings are consistent for patients affected by NSTI-causing pathogens that are not endemic to our region. This prospective, observational, multicenter clinical study will involve video-rate ICG fluorescence imaging of patients suspected of having NSTIs who present to eight tertiary, Level 1 medical centers across the United States (Aim 1). Using dynamic contrast-enhanced fluorescence imaging (DCE-FI), time profiles of ICG fluorescence intensity from different tissue pixels/regions will be extracted and parameterized to extract first-pass kinetic features. These DCE-FI features, which characterize tissue perfusion, will be evaluated alone and in combination with anonymized electronic medical record data to create a DCE-FI-based clinical decision tool and a machine- learning-based fusion (DCE FI+lab/imaging data) tool; these will be compared to identify the most accurate means of diagnosing NSTIs (Aim 2). The best-performing tool will then be evaluated-compared to current diagnostic tests-in a prospective observational clinical study of patients presenting to tertiary emergency departments with findings concerning for NSTIs (Aim 3). Based on our human study, fluorescence imaging will not delay current standard of care. To ensure data fidelity, all sites will use similar: 1) commercial fluorescence imaging systems and accessories; and 2) validated commercial fluorescence reference phantoms. Based on our early results, we have strong confidence that following rigorous testing, ICG DCE-FI will lead to an entirely new methodology for rapid identification of patients with NSTIs, which will ultimately reduce patient morbidity and improve survival.","conditions":["Necrotizing Fascitis"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Administration of indocyanine green (ICG) and fluorescence imaging"}],"enrollment":420,"startDate":"2025-09-26","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years.\n* Clinical suspicion of NSTI based on the local standard of care warranting:\n* Hospital admission for observation due to suspected NSTI; and/or\n* Soft tissue biopsy to rule in/out suspected NSTI; and/or\n* Surgical debridement for suspected NSTI; and/or\n* Specific institutional threshold criteria for triggering NSTI work-up; and\n* Ability to give written informed consent.\n\nExclusion Criteria:\n\n* History of allergy to ICG and/or iodine.\n* Pregnant women or nursing mothers.","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University/Grady Memorial Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric R Henderson, MD","phone":"603-650-5133","email":"Eric.R.Henderson@hitchcock.org"},{"name":"Morgan T Mazanec, MPH","phone":"603-308-9233","email":"Morgan.T.Mazanec@Hitchcock.ORG"}],"primaryOutcomes":["Determine if tissue perfusion, determined by first-pass ICG fluorescence kinetics, is reliably reduced in the setting of a necrotizing infection compared to a non-necrotizing infection."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","stanford-california","atlanta-georgia","ann-arbor-michigan","lebanon-new-hampshire","philadelphia-pennsylvania","pittsburgh-pennsylvania","nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: Administration of indocyanine green (ICG) and fluorescence imaging for Necrotizing Fascitis","inPlainEnglish":"Necrotizing soft-tissue infections (NSTIs, a.k.a. \"necrotizing fasciitis\" or \"flesh-eating bacteria\") are aggressive infections that can progress rapidly from mild symptoms to sepsis, multi-organ failure, and death.","whoItsFor":["Ages 18 Years to any","Clinical suspicion of NSTI based on the local standard of care warranting:","Hospital admission for observation due to suspected NSTI; and/or","Soft tissue biopsy to rule in/out suspected NSTI; and/or","Surgical debridement for suspected NSTI; and/or","Specific institutional threshold criteria for triggering NSTI work-up; and"],"whoShouldSkip":["History of allergy to ICG and/or iodine","Pregnant women or nursing mothers"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 420 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.428Z"},{"nctId":"NCT06878066","title":"Thrombolysis in Factor Xa-inhibitors Trial","officialTitle":"The Efficacy and Safety of Intravenous Thrombolysis in Acute Ischemic Stroke Patients With Recent Ingestion of Factor Xa-inhibitors Trial (SIFT)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Guri Hagberg","sponsorClass":"OTHER","summary":"This study looks at whether stroke patients who take FXa inhibitors (a type of blood thinner) can safely receive clot-busting treatment (IVT). IVT is a common emergency treatment for stroke, but current guidelines say it should not be given to people who have taken FXa inhibitors in the last 48 hours. This is because doctors worry that IVT might cause dangerous bleeding in the brain.\n\nHowever, new research suggests that IVT might be safe for these patients. Some studies even show that stroke patients on FXa inhibitors who receive IVT do not have a higher risk of brain bleeding than other stroke patients. But because these studies were not designed as full medical trials, doctors still avoid IVT for this group.\n\nThe SIFT trial will compare two groups of stroke patients who take FXa inhibitors:\n\nOne group will receive IVT to see if it helps them recover better. One group will not receive IVT, which is the current standard. Doctors will check if IVT helps with recovery and if it causes any serious bleeding. If IVT is found to be safe and effective, this study could change stroke treatment guidelines and help more patients get life-saving care.\n\nRight now, some guidelines say that stroke patients on FXa inhibitors should have a blood test before getting IVT, to measure how much of the drug is in their system. But these tests are not available in most hospitals, and waiting for results could delay important treatment. The SIFT trial will not require this test before giving IVT.\n\nMore and more people use FXa inhibitors to prevent strokes, but right now, they are being denied IVT based on old rules. If this study proves that IVT is safe for them, it could help doctors give better care to thousands of stroke patients.","conditions":["Stroke","Stroke (in Patients With Atrial Fibrillation)","Ischemic Stroke","Acute Ischemic Stroke","Anticoagulant Therapy","Factor Xa Inhibitor","Intracranial Hemorrhages","Hemorrhagic Transformation Due to Acute Stroke","Bleeding in the Brain"],"keywords":["Thrombolysis","Acute Ischemic Stroke","Ischemic Stroke","Factor Xa Inhibitors","Atrial Fibrillation-Related Stroke","Intravenous Thrombolysis","Tissue Plasminogen Activator","Tenecteplase","Alteplase","Symptomatic Intracranial Hemorrhage","SIFT Trial","Stroke","Acute stroke","Direct Oral Anticoagulants","DOACs"],"interventions":[{"type":"DRUG","name":"thrombolysis therapy"}],"enrollment":300,"startDate":"2025-03-14","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant must be 18 years of age or older.\n2. Ingestion of FXa inhibitors within the last 48 hours of symptom onset (or ongoing prescription of FXa inhibitor if unknown)\n3. Clinical diagnosis of AIS with disabling neurological deficit\n4. Presenting within 4.5 h of symptom onset or after awakening with symptoms of AIS with FLAIR-DWI mismatch on MRI as judged by the (neuro-) radiologist.\n5. Informed consent\n\nExclusion Criteria:\n\n1. Endovascular treatment eligible patients with isolated large vessel occlusion of the intracranial internal carotid artery (ICA), the M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography and expected time from randomization to groin puncture of \\<30 minutes.\n2. Systolic BP \\>185 mmHg or diastolic BP \\>110 mmHg despite antihypertensive treatment.\n3. Known bleeding diathesis; manifest or recent severe bleeding; significant bleeding disorder last 6 months.\n4. Arterial puncture at a non-compressible site; biopsy or lumbar puncture \\<7 days; major surgery, traumatic external heart massage, obstetrical delivery or serious trauma \\<14 days; history of intracranial haemorrhage; stroke \\<2 months, CNS neurosurgery \\<2 months; serious head trauma \\<2 months; pericarditis; sepsis; bacterial endocarditis; pericarditis; acute pancreatitis; neoplasm with increased bleeding risk; any serious medical illness likely to interact with treatment (i.e. aortic dissection); confounding pre-existent neurological or psychiatric disease.\n5. Any condition that, in the opinion of the treating physician, puts a patient at risk if treated with thrombolysis (i.e. signs of cerebral hemorrhage, known cerebral amyloid angiopathy, CT with signs of early ischemia greater than one-third of the middle cerebral artery territory).\n\n   Prior/Concomitant Therapy\n6. Use of a) direct thrombin (II) inhibitor (Dabigatran) or b) warfarin with an INR ≥1.8; c) heparin \\<48 h; d) treatment dose of LMWH \\<24 h.\n\n   Prior/Concurrent Clinical Study Experience\n7. Hypersensitivity to Alteplase or Tenecteplase","locations":[{"facility":"Dept. of Neurology, Aalborg Universitetshospital","city":"Aalborg","state":"Aalborg","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology Aarhus University Hospital","city":"Aarhus","state":"Aarhus N","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept. of Medicine, Baerum Hospital","city":"Baerum","state":"Gjettum","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Medicine, Helse More and Romsdal Health Trust, Aalesund Hospital","city":"Ålesund","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Medicine, Haraldsplass deaconal Hospital","city":"Bergen","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept. Of Neurology, Haukeland University Hopsital","city":"Bergen","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology, Drammen Hospital Trust","city":"Drammen","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology, Ostfold Hospital Trust, Kalnes","city":"Grålum","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology, Hospital of Southern Norway, SSHF","city":"Kristiansand","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology, Innlandet Hospital Trust, Lillehammer","city":"Lillehammer","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept. of Neurology, Oslo University Hospital","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept of Neurology, Stavanger University Hospital","city":"Stavanger","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept. of Neurology, Tromso University Hospital","city":"Tromsø","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dept. 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impact participants safety or study outcomes","Tuberculosis requiring treatment within 12 months prior V2","Malignancies current or past","Concomitant therapies:","Macrolides (less than 6 months)"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab, or Placebo. 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Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.\n\nCurrently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.\n\nThe goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).\n\nThis study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.\n\nTo achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.\n\nThe app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:\n\n* to implement a strategy for delay progression of liver disease;\n* to reduce the effect of cirrhosis (tertiary prevention).","conditions":["NASH","NAFLD"],"keywords":[],"interventions":[],"enrollment":252,"startDate":"2025-01-16","completionDate":"2026-12-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with MASLD and LSM\\>= 10 kPa\n* Age \\>= 18 years old\n* Sufficient digital literacy or supported from a caregiver with sufficient digital literacy\n* Smartphone (Android or iOS) able to download and run the App\n* Able to understand and communicate in Italian\n* Able to sign the informed consent\n\nExclusion Criteria:\n\n* Major psychiatric disorder\n* Not able to use digital technologies","locations":[{"facility":"Fondazione Policlinico Universitario A. 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Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.","whoItsFor":["Ages 18 Years to any","Diagnosed with MASLD and LSM\\>= 10 kPa","Age \\>= 18 years old","Sufficient digital literacy or supported from a caregiver with sufficient digital literacy","Smartphone (Android or iOS) able to download and run the App"],"whoShouldSkip":["Major psychiatric disorder","Not able to use digital technologies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 252 people at Rome. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.167Z"},{"nctId":"NCT06880705","title":"The Trans-Led Care Study","officialTitle":"A Gender-Affirming Stigma Intervention to Improve Substance Misuse and HIV Risk Among Transgender Women","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Illinois Institute of Technology","sponsorClass":"OTHER","summary":"This study is testing a new mutual-help group called \"the TLC program\" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or \"ACT\" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.","conditions":["Substance Abuse","Substance Addiction","Substance Use Disorder (SUD)","Substance Use (Drugs, Alcohol)","Human Immunodeficiency Virus (HIV)"],"keywords":["Substance misuse","HIV risk","Stigma","Psychological distress","Gender affirmation"],"interventions":[{"type":"BEHAVIORAL","name":"The TLC Program"}],"enrollment":124,"startDate":"2026-04-14","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nEligible transgender adults must:\n\n1. be 18 years of age or older;\n2. speak primarily English;\n3. live in the U.S.;\n4. have a gender identity different from their assumed gender, or sex assigned, at birth;\n5. identify as a person of transgender experience;\n6. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.","locations":[{"facility":"Illinois Institute of Technology","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arryn Guy, PhD","phone":"312-567-6467","email":"aguy1@iit.edu"}],"primaryOutcomes":["Gender Minority Stress and Resilience Scale Internalized Transphobia","Health Care Empowerment Inventory","Patient-Reported Outcomes Measurement Information System (PROMIS)","Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)","The Acceptability of Intervention Measure (AIM)","Intervention Appropriateness Measure","Feasibility of Intervention Measure (FIM)"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: The TLC Program for Substance Abuse","inPlainEnglish":"This study is testing a new mutual-help group called \"the TLC program\" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or \"ACT\" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health.","whoItsFor":["Ages 18 Years to any","Eligible transgender adults must:","be 18 years of age or older;","speak primarily English;","have a gender identity different from their assumed gender, or sex assigned, at birth;","identify as a person of transgender experience;","endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are The TLC Program. The registry lists allocation as randomized. This study is testing a new mutual-help group called \"the TLC program\" for transgender adults who use substances or are recently in recovery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 124 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.531Z"},{"nctId":"NCT06881979","title":"High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases - Fit4MedRob-Chronic MND Project","officialTitle":"Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Chronic Adult Neuromuscular Diseases (Fit4MedRob-Chronic MND Project)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue.\n\nThe main question it aims to answer is:\n\nAre high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, not inferior to traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with chronic neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.","conditions":["Amyotrophic Lateral Sclerosis","Chronic Inflammatory Demyelinating Neuropathy","Charcot-Marie-Tooth Disease"],"keywords":["high-tech rehabilitation","chronic neuromuscular disease","robotic platform"],"interventions":[{"type":"DEVICE","name":"High-tech rehabilitative treatment"},{"type":"OTHER","name":"Rehabilitation"}],"enrollment":60,"startDate":"2025-04-28","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT)\n* Patient able to walk independently or with assistance\n* Patients capable of understanding and adhering to the study protocol.\n* Patients who have provided informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients with unstable medical conditions (e.g. severe cardiovascular diseases, such as \"New York Heart Association\" - NYHA=4, respiratory distress not compensated by ventilation) that could interfere, in the clinician's judgment, with their ability to safely participate in the study or to perform the assessments related to the protocol.\n* Patients currently participating in other clinical trials that could interfere with this study.\n* Pregnant women.","locations":[{"facility":"IRCCS Azienda Ospedaliera Universitaria San Martino - Genova","city":"Genova","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri IRCCS, Milan Institute","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria di Modena","city":"Modena","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri","city":"Montescano","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri IRCCS","city":"Pavia","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Don Carlo Gnocchi Onlus","city":"Roma","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri IRCCS","city":"Telese Terme","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christian Lunetta, MD","phone":"+39 0250725266","email":"christian.lunetta@icsmaugeri.it"}],"primaryOutcomes":["Change from baseline in Fatigue Severity Scale"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["genova-italy","milan-italy","modena-italy","montescano-italy","pavia-italy","roma-italy","telese-terme-italy"],"enrichment":{"headline":"Not a traditional drug phase: High-tech rehabilitative treatment for Amyotrophic Lateral Sclerosis","inPlainEnglish":"The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue. The main question it aims to answer is: Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, not inferior to traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with chronic neuromuscular diseases (NMDs)?","whoItsFor":["Ages 18 Years to 80 Years","Patients with a confirmed diagnosis of chronic neuromuscular diseases (e.g. ALS, CIDP, CMT)","Patient able to walk independently or with assistance","Patients capable of understanding and adhering to the study protocol"],"whoShouldSkip":["Patients currently participating in other clinical trials that could interfere with this study"],"whatHappens":"If you join, the listed intervention(s) are High-tech rehabilitative treatment, or Rehabilitation. The registry lists allocation as randomized. The primary objective is to demonstrate, in a population of chronic neuromuscular disease the non-inferiority of a rehabilitation treatment integrated with robotic and/or technological devices compared to traditional rehabilitation treatment in the level of fatigue.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 7 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.602Z"},{"nctId":"NCT06882785","title":"A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia","officialTitle":"A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia","conditions":["Schizophrenia"],"keywords":[],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"OTHER","name":"Placebo"}],"enrollment":250,"startDate":"2025-06-10","completionDate":"2028-09-23","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).\n* Participants must have a PANSS total score between 80 and 120, inclusive.\n* Participants must have a CGI-S score of ≥ 4.\n\nExclusion Criteria\n\n* Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.\n* Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.\n* Participants must not have any history or presence of clinically significant medical conditions.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Hotei Hospital","city":"Kōnan","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okehazama Hospital","city":"Toyoake","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujita Health University","city":"Toyoake","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Kohnodai Medical Center.","city":"Ichikawa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0032","city":"Iizuka","state":"Fukuoka","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0037","city":"Kitakyushu","state":"Fukuoka","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shiranui Hospital","city":"Omuta","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Takeda General Hospital - Aizuwakamatsu","city":"Aizu-Wakamatsu","state":"Fukushima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital - Toki","city":"Toki","state":"Gifu","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kure Medical Center","city":"Kure","state":"Hiroshima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Goryokai Medical Corporation - Goryokai Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0025","city":"Hadano-shi","state":"Kanagawa","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fujimidai Hospital","city":"Hiratsuka","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kitasato University Hospital","city":"Sagamihara","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tsurumi Nishii Hospital","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama City University Medical Center","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hino Hospital - Yokohama","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yuge Hospital","city":"Kumamoto","state":"Kumamoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0019","city":"Yatsushiro","state":"Kumamoto","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Hospital Organization Maizuru Medical Center","city":"Maizuru","state":"Kyoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miyakonojo Shinsei Hospital","city":"Miyakonojō","state":"Miyazaki","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0014","city":"Komoro","state":"Nagano","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0050","city":"Matsumoto","state":"Nagano","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of the Ryukyus Hospital","city":"Ginowan","state":"Okinawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Psychiatric Medical Center","city":"Hirakata","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Medical Center","city":"Moriguchi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagaokai Medical Corporation - Neyagawa Sanatorium","city":"Neyagawa","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shin-Abuyama Hospital","city":"Takatsuki","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Medical and Pharmaceutical University Hospital","city":"Takatsuki","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rainbow and Sea Hospital","city":"Karatsu-shi","state":"Saga-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inuo Hospital","city":"Tosu","state":"Saga-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Konan Hospital","city":"Kumagaya","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dokkyo Medical University Hospital","city":"Shimotsuga","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0054","city":"Shimotsuke","state":"Tochigi","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tochigi Prefectural Okamotodai Hospital","city":"Utsunomiya","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0012","city":"Hachiōji","state":"Tokyo","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"National Center of Neurology and Psychiatry","city":"Kodaira","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asuka Hospital","city":"Machida","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toho University Omori Medical Center","city":"Ōta-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Matsuzawa Hospital","city":"Setagaya City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narimasu Kosei Hospital","city":"tabashi City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yamaguchi University Hospital","city":"Ube","state":"Yamaguchi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Shimofusa Psychiatric Medical Center","city":"Chiba","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kuramitsu Hospital","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital,Kyoto Prefectural University of Medicine","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miyazaki Prefectural Miyazaki Hospital","city":"Miyazaki","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital","city":"Okayama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0018","city":"Okinawa","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asakayama Hospital","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Neuropsychitric Institute","city":"Saitama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokushima University Hospital","city":"Tokushima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0033","city":"Tottori","state":"","country":"Japan","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Wakayama Medical University Hospital","city":"Wakayama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yamagata Sakuracho Hospital","city":"Yamagata","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score","Number of participants with treatment-emergent adverse events (TEAEs)"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["k-nan-japan","nagoya-japan","toyoake-japan","ichikawa-japan","iizuka-japan","kitakyushu-japan","omuta-japan","aizu-wakamatsu-japan","toki-japan","kure-japan","sapporo-japan","hadano-shi-japan","hiratsuka-japan","sagamihara-japan","yokohama-japan","kumamoto-japan","yatsushiro-japan","maizuru-japan","miyakonoj-japan","komoro-japan","matsumoto-japan","ginowan-japan","hirakata-japan","moriguchi-japan","neyagawa-japan","takatsuki-japan","karatsu-shi-japan","tosu-japan","kumagaya-japan","shimotsuga-japan","shimotsuke-japan","utsunomiya-japan","hachi-ji-japan","kodaira-japan","machida-japan","ta-ku-japan","setagaya-city-japan","tabashi-city-japan","ube-japan","chiba-japan","fukuoka-japan","kyoto-japan","miyazaki-japan","okayama-japan","okinawa-japan","osaka-japan","saitama-japan","tokushima-japan","tottori-japan","wakayama-japan","yamagata-japan"],"enrichment":{"headline":"Phase 3: testing KarXT for Schizophrenia","inPlainEnglish":"This study wants to measure the how well it works and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia","whoItsFor":["Ages 18 Years to 65 Years","Participants must have a PANSS total score between 80 and 120, inclusive","Participants must have a CGI-S score of ≥ 4"],"whoShouldSkip":["Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening","Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia","Participants must not have any history or presence of clinically significant medical conditions","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are KarXT, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 250 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.042Z"},{"nctId":"NCT06883019","title":"Lecanemab for Early Onset Familial Alzheimer's Disease","officialTitle":"A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"RenJi Hospital","sponsorClass":"OTHER","summary":"The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.","conditions":["Alzheimer Disease"],"keywords":["Alzheimer Disease"],"interventions":[],"enrollment":114,"startDate":"2025-03-13","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.\n* Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.\n* MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5\n* No significant signs found in the neurological examination\n* Participants must be capable of completing cognitive assessments and other tests.\n* Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.\n\nExclusion Criteria:\n\n* Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.\n* Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.\n* Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.\n* Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.\n* Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).\n* Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales.\n* Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.\n* MRI findings showing more than four microhemorrhages (diameter \\< 10 mm), evidence of surface iron deposition, vascular edema, diffuse white matter disease, multiple lacunar strokes, or any strokes involving major vascular regions. Presence of evidence of cerebral contusions, brain softening, cerebral aneurysms, or other vascular malformations, central nervous system (CNS) infections, as well as brain tumors other than meningiomas or arachnoid cysts.\n* Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.\n* Pregnant or lactating women.\n* Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.\n* Patients with severe allergies to lecanemab or any excipients of this product.","locations":[{"facility":"Xuanwu Hospital, Capital Medical University","city":"Beijing","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guangzhou Medical University","city":"Guangdong","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Guizhou Medical University","city":"Guizhou","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Brain Hospital","city":"Jiangsu","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital","city":"Jiangsu","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nantong First People's Hospital","city":"Jiangsu","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huadong Hospital, Fudan University","city":"Shanghai","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Mental Health Center","city":"Shanghai","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University","city":"Sichuan","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinhua Central Hospital","city":"Zhejiang","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ningbo Second Hospital","city":"Zhejiang","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Zhejiang University School of Medicine","city":"Zhejiang","state":"China","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jinwen Xiao","phone":"+86 13917310784","email":"jw_xiao78@163.com"}],"primaryOutcomes":["Chang of CDR-SB score"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["beijing-china","guangdong-china","guizhou-china","jiangsu-china","shanghai-china","sichuan-china","tianjin-china","zhejiang-china"],"enrichment":{"headline":"Lecanemab for Early Onset Familial Alzheimer's Disease","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to learn about the how well it works of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing.","whoItsFor":["Ages 18 Years to 65 Years","Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender","MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5","No significant signs found in the neurological examination","Participants must be capable of completing cognitive assessments and other tests"],"whoShouldSkip":["Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months","Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium","Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses","Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA)","Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales","Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants","Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 114 people at 15 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.236Z"},{"nctId":"NCT06883305","title":"A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006)","officialTitle":"A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)","conditions":["Chronic Obstructive Pulmonary Disease (COPD)"],"keywords":["COPD","Moderate COPD","Severe COPD","Very Severe COPD","chronic obstructive pulmonary disease"],"interventions":[{"type":"BIOLOGICAL","name":"Tezepelumab"},{"type":"OTHER","name":"Placebo"}],"enrollment":990,"startDate":"2025-03-18","completionDate":"2029-03-13","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ≥40 to ≤80 years old\n2. 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Malignancies current or past\n\n   Concomitant therapies:\n   * Macrolides (less than 6 months)\n   * Systemic immuno-suppressive, -modulating medications\n6. 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impact participants safety or study outcomes","Tuberculosis requiring treatment within 12 months prior V2","Malignancies current or past","Concomitant therapies:","Macrolides (less than 6 months)"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab, or Placebo. The registry lists allocation as randomized. A Multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, Parallel Group, Phase 3 Study to measure the how well it works and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 990 people at 258 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.864Z"},{"nctId":"NCT06885125","title":"Dietary Intervention to Improve Fertility in Women With Endometriosis Undergoing IVF","officialTitle":"Randomized Controlled Study on the Effect of a DietAry interveNtion in Ameliorating fertiliTy Parameters in Women With endomEtriosis Undergoing IVF (The DANTE Study)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","sponsorClass":"OTHER","summary":"The goal of this randomized controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF).\n\nThe main questions are:\n\n* Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)?\n* Does it improve secondary outcomes such as embryo quality, pregnancy rates, inflammation markers, and quality of life?\n\nResearchers will compare two groups:\n\n* Women receiving standard IVF protocols.\n* Women undergoing the same IVF protocol plus the anti-inflammatory diet.\n\nParticipants will:\n\n* Be randomized into one of the two groups.\n* Follow dietary counseling sessions and complete dietary assessments (diet group).\n* Provide biological samples (e.g., plasma, vaginal and fecal swabs, and follicular fluid) before and after the dietary intervention to evaluate potential differences in inflammation, hormonal levels, and microbiome composition between the two groups and across timepoints (pre- and post-diet).\n* Complete questionnaires on quality of life, sexual function, and symptomatology severity before and after the intervention to assess differences between the two groups and across timepoints.","conditions":["Endometriosis"],"keywords":["IVF","endometriosis","anti-inflammatory diet"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"anti-inflammatory diet"}],"enrollment":438,"startDate":"2025-03-24","completionDate":"2029-06-30","sex":"FEMALE","minAge":"18 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\< 40 years\n* Pregnancy seeking for more than 12 months\n* Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days\n* Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.\n* Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve).\n* Absence of ureteral stenosis or intestinal subocclusive symptoms\n\nExclusion Criteria:\n\n* Contraindication to pregnancy\n* Hydrosalpinx\n* Endometriomas with a mean diameter \\> 4 cm\n* Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).\n* Doubtful sonographic findings that do not allow to reliably rule out malignancy.\n* severe male factor (\\<1 million sperm/ml)","locations":[{"facility":"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paola Vigano', PhD","phone":"+390255034302","email":"paola.vigano@policlinico.mi.it"},{"name":"Marco Reschini, MSc","phone":"+390255034303","email":"marco.reschini@policlinico.mi.it"}],"primaryOutcomes":["Inadequate ovarian response"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: anti-inflammatory diet for Endometriosis","inPlainEnglish":"The goal of this randomly assigned controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF). The main questions are: * Does the anti-inflammatory diet reduce the rate of inadequate ovarian response to hormonal stimulation (retrieval of ≤3 oocytes)?","whoItsFor":["Ages 18 Years to 39 Years","Women only","Pregnancy seeking for more than 12 months","Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days","Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis","Antral Follicle Counts (AFC) ≥ 5 (no other cause of reduced ovarian reserve)","Absence of ureteral stenosis or intestinal subocclusive symptoms"],"whoShouldSkip":["Contraindication to pregnancy","Endometriomas with a mean diameter \\> 4 cm","Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm)","Doubtful sonographic findings that do not allow to reliably rule out malignancy","severe male factor (\\<1 million sperm/ml)"],"whatHappens":"If you join, the listed intervention(s) are anti-inflammatory diet. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to assess whether a 12-week anti-inflammatory diet can improve fertility outcomes in women with endometriosis undergoing In Vitro Fertilization (IVF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 438 people at Milan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.109Z"},{"nctId":"NCT06885697","title":"Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","officialTitle":"Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nMesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma. Researchers are developing a new treatment that collects a person s own immune cells (T cells); the T cells are genetically modified to target and kill tumor cells with high levels of MSLN.\n\nObjective:\n\nTo test a new treatment (TNhYP218 CAR T cells) in people with solid tumors including mesothelioma.\n\nEligibility:\n\nPeople aged 18 and older with solid tumors including mesothelioma that returned or spread after standard treatment.\n\nDesign:\n\nParticipants will be screened. A small piece of tissue will be cut from a tumor (biopsy). The sample will be tested to see if it has enough MSLN.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein.\n\nParticipant s T cells will be modified in a lab to produce TNhYP218 CAR T cells.\n\nParticipants will enter the hospital. For 7 days, they will receive drugs to prepare their bodies for the study treatment.\n\nTNhYP218 CAR T cells will be administered into a vein. Participants will remain in the hospital for at least 7 more days.\n\nAfter discharge, participants will have follow-up visits for 5 years. These visits may include imaging scans, blood and heart tests, and a new biopsy.\n\nLong-term follow-up will continue another 10 years....","conditions":["Mesothelioma","Neoplasms","Stomach Neoplasms","Pancreatic Neoplasms","Ovarian Neoplasms","Lung Neoplasms","Thymus Neoplasms","Colonic Neoplasms"],"keywords":["Peritoneal Mesothelioma","Thymic Carcinoma","Colon Cancer","Gastric Cancer","Lung Cancer","Ovarian Cancer","Pancreatic Cancer","mesothelin expressing solid tumors","CAR T cell therapy","Gene Therapy"],"interventions":[{"type":"DRUG","name":"cyclophosphamide"},{"type":"DRUG","name":"fludarabine"},{"type":"BIOLOGICAL","name":"TNhYP218 CAR T Cells"},{"type":"DEVICE","name":"mesothelin expression testing"}],"enrollment":120,"startDate":"2025-07-08","completionDate":"2034-06-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy.\n\n* Participant must have unresectable, locally advanced, or metastatic, or recurrent mesothelioma and other mesothelin expressing solid tumors. For participants with mesothelioma only those with epithelioid or biphasic histology (with \\>80% epithelioid component) will be eligible. The diagnosis will be confirmed by the Laboratory of Pathology, CCR, NCI.\n* Participant must have progressed on at least one FDA-approved systemic therapy considered standard of care for their tumor type. There is no limit on the number of prior treatment regimens. Note: Given the aggressive nature of pancreatic cancer, otherwise eligible individuals with this cancer type can undergo leukapheresis before or while they are getting their frontline treatment as long as they meet all other inclusion criteria. However, TNhYP218 CAR T cells will only be administered after progression on first line standard of care therapy.\n* Participant must have at least 1 measurable lesion by RECIST version 1.1.\n* Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue.\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Participants must have adequate organ and marrow function as defined below:\n\nSystem: Laboratory Value\n\nHematological\n\n* Hemoglobin: \\>=9 g/dL(a)\n* absolute neutrophil count: \\>=1,500/mcL\n* platelets: \\>=100,000/mcL\n\nHepatic\n\n* total bilirubin: \\<=2.5 X institutional ULN OR direct bilirubin \\<= ULN for participants with total bilirubin levels \\>1.5 X ULN\n* AST and ALT \\<= 2.5 X institutional ULN (\\<= 5 X ULN for participants with liver metastases)\n\nRenal\n\n* Creatinine OR: \\<=1.5 X ULN OR\n* Calculated(b) creatinine clearance (GFR can also be used in place of creatinine or CrCl) \\>= 50 mL/min for participant with creatinine levels \\> 1.5 X institutional ULN\n\nCoagulation\n\n* International normalized ratio (INR) OR prothrombin time (PT): \\<=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n* Activated partial thromboplastin time (aPTT): \\<=1.5 X ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\n\nALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal.\n\n1. Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 7 days.\n2. Creatinine clearance (CrCl) should be calculated per institutional standard.\n\n   * Normal cardiac ejection fraction (\\>= 45% by echocardiogram) and no evidence of hemodynamically significant pericardial effusion as determined by an echocardiogram.\n   * Room air oxygen saturation of 90% or greater.\n   * Treatment-related toxicities from prior treatments must be resolved to \\<= grade 2.\n   * Participants with CNS metastases, leptomeningeal disease or carcinomatous meningitis are eligible if they are asymptomatic, have completed their treatment for CNS disease and have recovered from the acute effects of radiation therapy or surgery prior to study entry. Participants must have radiographically stable CNS disease without associated edema at least three months prior to study entry. Additionally, participants have had to have discontinued corticosteroid treatment or non-prophylactic antiseizure medications for these metastases at least four weeks prior to study entry.\n   * Participants of child-bearing potential and participants who can father children must agree to use highly effective contraception or abstinence.\n   * Participants who are nursing or plan to nurse a child must agree to discontinue/postpone nursing for the duration of study therapy and for 12 months after the administration of the cell product or for 4 months from the time no evidence of persistence/gene modified cells is documented in the participant s blood.\n   * Ability of participant to understand and the willingness to sign a written informed consent document.\n\n   EXCLUSION CRITERIA:\n\n   An individual who meets any of the following criteria will be excluded from participation in this study:\n   * Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy.\n   * Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation.\n   * Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency).\n   * Participants with active or history of autoimmune or immune mediated disease such as multiple sclerosis, lupus, inflammatory bowel disease, rheumatoid arthritis, or small vessel vasculitis. NOTE: Participants with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.\n   * History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.\n   * Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg/day of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed.\n   * Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders.\n   * Participant has any other prior or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 12 months prior to initiation of study therapy.\n     * Treated non-melanoma skin cancer.\n     * Stage 0 or 1 melanoma completely resected at least 12 months prior to initiation of study therapy.\n     * Successfully treated organ-confined prostate cancer with no evidence of progressive disease based on PSA levels and are not on active therapy.\n     * A primary malignancy which has been completely resected and in complete remission for \\>= 5 years.\n   * Electrocardiogram showing a QTc interval \\> 450 msec in males and \\> 470 msec in females (\\> 80 msec for participants with bundle branch block). Either Fridericia s or Bazett s formula may be used to correct the QT interval.\n   * Participant has active infection with HIV, hepatitis B virus, HCV, or HTLV as defined below:\n\n     * Positive serology for HIV, HTLV-1, or HTLV-2.\n     * Active hepatitis B infection as demonstrated by test for hepatitis B surface antigen. Participants who are hepatitis B surface antigen negative but are hepatitis B core antibody positive must have undetectable hepatitis B DNA and receive prophylaxis against viral reactivation.\n     * Active hepatitis C infection as demonstrated by hepatitis C RNA test. Participants who are HCV antibody positive will be screened for HCV RNA by any reverse transcription PCR or branched DNA assay. If HCV antibody is positive, eligibility will be determined based on a negative screening RNA value.\n   * Participant is pregnant or intends to be pregnant during the required period of contraception for participants of childbearing potential.\n   * Participants who received live or attenuated vaccine or virus-based vaccine within 30 days before initiation of treatment initiation\n   * Participants with a history of seizure disorder unless due to now treated metastatic lesions.\n   * Ongoing uncontrolled intercurrent illness, including but not limited to ongoing or active infection, that would impact participant safety or limit compliance with study requirements.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cathy I Wagner, R.N.","phone":"(240) 858-3159","email":"cathy.wagner@nih.gov"},{"name":"Raffit Hassan, M.D.","phone":"(240) 760-6232","email":"rh276q@nih.gov"}],"primaryOutcomes":["Establish the recommended phase 2 dose (RP2D) of TNhYP218 CAR T cells based on dose-limiting toxicity (DLT) of defined adverse events (AEs).","Determine the preliminary objective response rate of TNhYP218 CAR T cells in a limited number of participants with mesothelioma treated at the recommended phase 2 dose."],"hasResults":false,"conditionSlugs":["lung-cancer","pancreatic-cancer","ovarian-cancer","stomach-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing cyclophosphamide for Mesothelioma","inPlainEnglish":"Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs. Mesothelin (MSLN) is a protein that appears in high numbers in many tumors, including mesothelioma.","whoItsFor":["Ages 18 Years to 120 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria. For this protocol, treatment initiation is defined as the first day of lymphodepleting chemotherapy","Participant must have at least 1 measurable lesion by RECIST version 1.1","Tumor must have MSLN positivity of 2+ to 3+ in \\>= 50% cancer cells by immunohistochemistry on freshly collected biopsy or archival tissue","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Participants must have adequate organ and marrow function as defined below:","System: Laboratory Value","Hemoglobin: \\>=9 g/dL(a)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Prior systemic therapy, an investigational therapy, radiation, and/or surgery within 14 days prior to leukapheresis and 21 days prior to lymphodepleting chemotherapy","Prior administration of anti-PD-1 or anti-PD-L1 antibodies or other agents that in the opinion of the PI can stimulate immune activity and interfere with an infusion of CAR-T cells within 8 weeks prior to treatment initiation","Participants with any form of primary immunodeficiency (e.g. severe combined immunodeficiency)","History of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine","Therapeutic doses of systemic corticosteroid therapy within 14 days prior to treatment initiation. Physiological doses of steroids (up to 5mg/day of prednisolone or equivalent) are allowed. Corticosteroid creams, ointments, and eye drops are allowed","Participants with lung fibrosis, inflammatory lung disease or evidence of pneumonitis on baseline imaging studies or medical history of these disorders"],"whatHappens":"If you join, the listed intervention(s) are cyclophosphamide, fludarabine, or TNhYP218 CAR T Cells. The registry lists allocation as randomized. Background: Mesothelioma is an aggressive cancer that grows in the linings of the body; this can include the membranes that line the heart, lungs, and internal organs.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 120 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.460Z"},{"nctId":"NCT06885957","title":"Monoclonal Antibody-Based Therapies for AQP4-Positive NMOSD","officialTitle":"A Registry Study on Monoclonal Antibody-Based Therapies for Aquaporin-4 Antibody-Positive Neuromyelitis Optica Spectrum Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Tongji Hospital","sponsorClass":"OTHER","summary":"The primary objective of this registry study is to evaluate the therapeutic efficacy and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.","conditions":["NMO Spectrum Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mab Therapy"}],"enrollment":200,"startDate":"2025-07-01","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects must demonstrate capacity to comprehend the study's objectives and associated risks, provide written informed consent, and authorize utilization of confidential health information in compliance with national and regional data protection regulations.\n* Enrollment is permitted regardless of biological sex, with age ≥18 and ≤65 years (inclusive) at the time of informed consent provision.\n* All females of childbearing potential and biologically male participants must employ contraceptive measures meeting clinical trial standards throughout the study duration and for at least 30 days following the final administration of investigational therapy. Additionally, participants must abstain from gamete donation during the study period and for ≥30 days post-treatment cessation.\n* Confirmed diagnosis of aquaporin-4 immunoglobulin G (AQP4-IgG)-seropositive neuromyelitis optica spectrum disorders (NMOSD) per the 2015 International Consensus Diagnostic Criteria, with serological or cerebrospinal fluid verification of AQP4-IgG positivity for inclusion in the AQP4-NMOSD cohort. Participants must have provided documented consent for therapeutic intervention with one monoclonal antibody-based biologics.\n* Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1).\n\nExclusion Criteria:\n\n* Medical History and Current Health Status\n\n  1. Clinically significant medical history of cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, renal, pulmonary, neurological, dermatologic, psychiatric, or other major systemic conditions that, in the investigator's judgment, would preclude safe trial participation.\n  2. Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score \\>3.\n  3. Hypersensitivity to the investigational therapeutic agent(s) or their excipients.\n* Infection Risk\n\n  1. Documented history or positive screening test for human immunodeficiency virus (HIV).\n  2. Active hepatitis C virus (HCV) infection, defined as detectable HCV RNA with concomitant anti-HCV antibody positivity. Subjects with anti-HCV antibody positivity and undetectable HCV RNA remain eligible.\n  3. Active hepatitis B virus (HBV) infection, defined as hepatitis B surface antigen (HBsAg) positivity and/or total hepatitis B core antibody (anti-HBc) positivity. Subjects with prior natural infection (HBsAg-negative, anti-HBc-positive, and anti-HBs-positive) or vaccination-induced immunity (HBsAg-negative, anti-HBc-negative, and anti-HBs-positive) are eligible.\n  4. Chronic, recurrent, or severe infections (e.g., pneumonitis, sepsis) within 90 days prior to baseline (Visit 1).\n  5. History of active tuberculosis (TB) or latent TB infection, defined by positive interferon-gamma release assay (IGRA) results or two consecutive tuberculin skin tests.\n  6. Active bacterial, fungal, or viral infections (including upper respiratory tract infections) within 28 days prior to baseline. Subjects with localized fungal infections (e.g., candidiasis, dermatophytosis) may undergo re-screening post-treatment.\n  7. Contraindications to rescue therapies, including rituximab, intravenous immunoglobulin (IVIG), high-dose corticosteroids, or cyclophosphamide.\n  8. Prior exposure to total lymphoid irradiation, cladribine, T-cell or T-cell receptor vaccination, total body irradiation, or hematopoietic stem cell transplantation at any time.\n* Additional Exclusion Criteria\n\n  1. Clinically significant suicidal ideation or behavior within the past 12 months, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).\n  2. Unwillingness or inability to comply with protocol-mandated procedures.\n  3. Severe auditory/visual impairment, language barriers, claustrophobia, or other conditions precluding neuropsychological assessments or MRI completion.\n  4. Any other condition deemed by the investigator or sponsor to compromise subject eligibility or study integrity.","locations":[{"facility":"Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Time to first relapse","Median time to relapse","Annualized relapse rate","EDSS score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["wuhan-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Mab Therapy for NMO Spectrum Disorder","inPlainEnglish":"The primary objective of this registry study is to measure the therapeutic how well it works and safety profiles of distinct monoclonal antibody-based therapies for aquaporin-4 immunoglobulin G-seropositive neuromyelitis optica spectrum disorders within the Chinese population under real-world clinical conditions. Secondary objectives include quantitative assessment of longitudinal neuroimaging biomarker variations and immunological profile alterations in longitudinal biological specimens pre- and post-therapeutic intervention.","whoItsFor":["Ages 18 Years to 65 Years","Neurological examination demonstrating clinical stability within 30 days preceding baseline (Visit 1)"],"whoShouldSkip":["Medical History and Current Health Status","Prior cerebrovascular events resulting in a baseline modified Rankin Scale (mRS) score \\>3","Hypersensitivity to the investigational therapeutic agent(s) or their excipients","Documented history or positive screening test for human immunodeficiency virus (HIV)","Active hepatitis C virus (HCV) infection, defined as detectable HCV RNA with concomitant anti-HCV antibody positivity. Subjects with anti-HCV antibody positivity and undetectable HCV RNA remain eligible","Chronic, recurrent, or severe infections (e.g., pneumonitis, sepsis) within 90 days prior to baseline (Visit 1)","History of active tuberculosis (TB) or latent TB infection, defined by positive interferon-gamma release assay (IGRA) results or two consecutive tuberculin skin tests"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Wuhan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.279Z"},{"nctId":"NCT06889818","title":"Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)","officialTitle":"Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ewha Womans University Mokdong Hospital","sponsorClass":"OTHER","summary":"The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to evaluate the impact of these new therapies and diagnostic techniques in clinical practice.","conditions":["Mild Cognitive Impairment","Dementia","Subjective Cognitive Decline (SCD)","Alzheimer Disease"],"keywords":["Real World Data","Lecanemab"],"interventions":[],"enrollment":4000,"startDate":"2025-02-24","completionDate":"2034-12-31","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants must be 19 years of age or older at the time of informed consent.\n2. Patients who are undergoing medical evaluation for newly approved Alzheimer's disease medications after 2021, patients who have decided to initiate treatment with these medications in consultation with their physician after 2021, or patients who have already started treatment with newly approved Alzheimer's disease medications after 2021.\n3. Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181.\n4. Clinical diagnosis of Alzheimer's disease, defined as follows:\n\n<!-- -->\n\n1. \\[Alzheimer's Disease Dementia (ADD)\\] - Must meet the criteria for probable Alzheimer's dementia as defined by the National Institute on Aging and the Alzheimer's Association working groups (NIA-AA).\n\n   * Must exhibit cognitive decline that impairs independent daily living.\n2. \\[Mild Cognitive Impairment (MCI)\\]\n\n   \\- Must meet NIA-AA diagnostic criteria for MCI.\n\n   \\- The subject or informant must report cognitive decline.\n\n   \\- Performance on delayed recall of verbal memory must be more than -1.0 SD below the age- and education-adjusted normative mean, or scores on any one or more tests of executive function, language, visuospatial abilities, or attention must be more than -1.5 SD below the age- and education-adjusted normative mean.\n\n   \\- Clinical Dementia Rating scale (CDR) of 0.5.\n\n   \\- Maintenance of independent daily living ability.\n\n   \\- Not categorized as dementia.\n3. \\[Cognitively Unimpaired (CU)\\]\n\n   \\- Delayed recall of verbal memory must be at or above -1.0 SD versus the age- and education-adjusted normative mean, and all executive function, language, visuospatial abilities, and attention tests must be at or above -1.5 SD versus the age- and education-adjusted normative mean.\n\n   \\- Maintenance of independent daily living ability.\n   * If the subject reports cognitive decline, they will be classified as having Subjective Cognitive Decline (SCD).\n\n     5\\. Patients must be ambulatory (use of mobility aids is acceptable). 6. The subject must provide written informed consent to participate in the study. In the case of dementia patients, additional written consent from a guardian is required.\n\nExclusion Criteria:\n\n1. Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc.\n2. History of substance abuse or alcohol dependence that required treatment within the past five years.\n3. A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded.\n4. Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease).\n5. Visual or auditory impairments that prevent the satisfactory assessment of cognitive function.\n6. Inability to perform MRI due to the presence of metallic substances in the body.\n7. Currently participating in another drug clinical trial.\n8. Currently pregnant or breastfeeding.","locations":[{"facility":"Gachon University Gil medical Center","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inha University Hospital","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ewha Womans University Mokdong Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Geon-ha Kim","phone":"82-2-587-7462","email":"geonha@ewha.ac.kr"}],"primaryOutcomes":["Change from baseline in the Korean Mini-Mental State Examination-2 (K-MMSE-2) total score","Change from baseline in the Korean version of Montreal Cognitive Assessment (K-MOCA) total score","Change from baseline in the Clinical Dementia Rating scale (CDR) total score","Change from baseline in the Functional Assessment Questionnaire (FAQ) total score","Change from baseline in the Korean version of the Alzheimer disease 8 (K-AD8) total score"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab","donanemab"],"locationSlugs":["incheon-south-korea","seoul-south-korea"],"enrichment":{"headline":"Korean Joint Registry for Alzheimer's Treatment and Diagnostics (JOY-ALZ)","inPlainEnglish":"The purpose of this research is to investigate the long-term effectiveness and safety of new Alzheimer's disease treatments, particularly monoclonal antibody therapies like lecanemab and donanemab, as well as to enhance diagnostic methods for Alzheimer's disease by collecting real-world data from Korean Alzheimer's patients. The goal is to contribute to the precision of Alzheimer's treatment and to measure the impact of these new therapies and diagnostic techniques in clinical practice.","whoItsFor":["Ages 19 Years to any","Patients who have undergone an amyloid PET scan to confirm Alzheimer's disease pathology, or cerebrospinal fluid testing for Aβ42 and ptau181","Clinical diagnosis of Alzheimer's disease, defined as follows:","\\[Alzheimer's Disease Dementia (ADD)\\] - Must meet the criteria for probable Alzheimer's dementia as defined by the National Institute on Aging and the Alzheimer's Association working groups (NIA-AA)","Must exhibit cognitive decline that impairs independent daily living","\\[Mild Cognitive Impairment (MCI)\\]","\\- Must meet NIA-AA diagnostic criteria for MCI","\\- The subject or informant must report cognitive decline"],"whoShouldSkip":["Presence of significant psychiatric disorders associated with intellectual disability, schizophrenia, major depression, bipolar disorder, delirium, etc","History of substance abuse or alcohol dependence that required treatment within the past five years","A current diagnosis of cancer that has not achieved remission within the past five years. However, localized prostate cancer, cervical carcinoma in situ, non-melanoma skin basal cell carcinoma, or squamous cell carcinoma are excluded","Evidence of severe or unstable physical conditions (e.g., dialysis, severe liver disease)","Visual or auditory impairments that prevent the satisfactory assessment of cognitive function","Inability to perform MRI due to the presence of metallic substances in the body","Currently participating in another drug clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 4,000 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.235Z"},{"nctId":"NCT06891300","title":"Understanding and Treating Suicidal Ideation With Ketamine","officialTitle":"Understanding and Treating Suicidal Ideation With Ketamine: A Diffusion Magnetic Resonance Imaging Study","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Royal's Institute of Mental Health Research","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (MDD) using ketamine and to understand suicidal ideation by examining biological mechanisms using magnetic resonance imaging (MRI), and psychological mechanisms through validated clinical scales and qualitative interviews. The main questions it aims to answer are:\n\n1. Will ketamine will reduce suicidal ideation in a significant proportion of study participants?\n2. Will reduction in suicidal ideation will be accompanied by rapid changes in neuroimaging biomarkers?\n\nParticipants will receive four intravenous (IV) ketamine infusions administered twice weekly for two weeks. Participants will undergo two identical MRI scans: 1) within 48 hours prior to starting ketamine treatment, and 2) 24 hours after the fourth ketamine infusion. Suicidal ideation and depressive symptoms will be assessed prior to each imaging session alongside additional self-report measures. Qualitative interviews will occur within 72 hours after the fourth ketamine treatment.","conditions":["Suicidal Ideation","Major Depressive Disorder (MDD)"],"keywords":["Major Depressive Disorder","Suicidal Ideation","Ketamine","Neuroimaging"],"interventions":[{"type":"DRUG","name":"ketamine hydrochloride"}],"enrollment":36,"startDate":"2025-04-08","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. English speaking\n2. Ages 18-65 years old\n3. Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit (\"active suicidal ideation with any methods\")\n4. Diagnosis of Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)\n5. Willing to maintain stable doses of concomitant medications throughout the study\n6. Be under the care of a designated health care provider (i.e., family physician or psychiatrist) to follow their care after the completion of the study.\n\nExclusion Criteria:\n\n1. Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, diabetes mellitus, seizure disorder).\n2. Known or suspected hypersensitivity or intolerance to ketamine\n3. Body mass index (BMI) ≥35\n4. History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\\<2 years) acute episode of psychosis\n5. Current and/or recent history (\\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria\n6. Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study\n7. History of significant head injury including loss of consciousness \\>5 minutes\n8. Any MRI contraindications\n9. Concurrent use of ketamine in any form\n10. Concurrent active ECT or repetitive transcranial magnetic stimulation (rTMS) therapy","locations":[{"facility":"Royal Ottawa Mental Health Centre","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Coordinator","phone":"613-722-6521","email":"suzannah.wojcik@theroyal.ca"}],"primaryOutcomes":["Change in white matter microstructure from pre-treatment to post-treatment, assessed via MRI."],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["ottawa-canada"],"enrichment":{"headline":"Phase 2 / Phase 3: testing ketamine hydrochloride for Suicidal Ideation","inPlainEnglish":"The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (major depression) using ketamine and to understand suicidal ideation by examining biological mechanisms using magnetic resonance imaging (MRI), and psychological mechanisms through validated clinical scales and qualitative interviews. The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to 65 Years","Ages 18-65 years old","Suicidal ideation severity score ≥3 on the Columbia Suicide Severity Rating Scale (C-SSRS) (Baseline/Screening version) at Screening Visit (\"active suicidal ideation with any methods\")","Diagnosis of Major Depressive Disorder (major depression) according to the Diagnostic and Statistical Manual for Mental Disorders 5th Edition (DSM-5)","Willing to maintain stable doses of concomitant medications throughout the study","Be under the care of a designated health care provider (i.e., family physician or psychiatrist) to follow their care after the completion of the study"],"whoShouldSkip":["Participants not medically cleared to receive ketamine treatment due to presence of clinically relevant disease (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, diabetes mellitus, seizure disorder)","Known or suspected hypersensitivity or intolerance to ketamine","Body mass index (body-mass index (BMI)) ≥35","History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\\<2 years) acute episode of psychosis","Current and/or recent history (\\<12 months) of substance use/dependence (except for caffeine or nicotine) or problematic current alcohol use or dependence as defined by DSM-5 criteria","Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study","History of significant head injury including loss of consciousness \\>5 minutes"],"whatHappens":"If you join, the listed intervention(s) are ketamine hydrochloride. The registry lists allocation as na. The goal of this clinical trial is to treat active suicidal ideation in individuals with Major Depressive Disorder (major depression) using ketamine and to understand suicidal ideation by examining biological mechanisms using magnetic resonance imaging (MRI), and psychological mechanisms through validated clinical scales and qualitative interviews.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 36 people at Ottawa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.107Z"},{"nctId":"NCT06891690","title":"Use of tDCS Stimulation in Neurological and Gynaecological Conditions","officialTitle":"Use of tDCS Stimulation in Neurological and Gynaecological Conditions","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Poznan University of Physical Education","sponsorClass":"OTHER","summary":"The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients. And the impact of tDCS stimulation on patients' quality of life. Standardised questionnaires will be used for pre- and post-stimulation evaluation.","conditions":["Stroke","Spinal Cord Diseases","Nerve Root Disorder","Endometriosis","Dyspareunia","Painful Menstruation","Polycystic Ovary"],"keywords":["tDCS stimulation","quality of life","pain"],"interventions":[{"type":"OTHER","name":"tDSC stimulation"}],"enrollment":300,"startDate":"2025-02-05","completionDate":"2026-09-30","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":true,"eligibilityRaw":"Neurological patients\n\nInclusion Criteria:\n\n* impairment of upper and lower limb function.\n\nExclusion Criteria:\n\n* no written consent to participate in the study.\n\nGynaecological patients\n\nInclusion Criteria:\n\n* women with selected gynaecological conditions (endometriosis, painful menstruation, dyspareunia, polycystic ovary syndrome) with no treatment other than tDCS stimulation.\n\nExclusion Criteria:\n\n* no written consent to participate in the study.","locations":[{"facility":"1Department of Physiotherapy, Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wlkp., 61-871 Poznan","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Małgorzata Wójcik, PhD PT","phone":"+48(95) 72 79 100","email":"m.wojcik@awf-gorzow.edu.pl"}],"primaryOutcomes":["body height using Tanita BC-418 MA device","biomechanical and viscoelastic properties of the skin using MyotonPRO","postural stability using the stabilometric platform Koordynacja","upper limb reaction time using the Witty SEM Microgate device","assessment of right and left limb compression strength (hand dynamometer)","lower limb reaction time using the Balance Toutor MedTouch platform","tDCS stimulation","tapping test, reflex Flop test, Nine-Hole-Peg Test","questionnaire Rolland-Morris","Barthel scale","ASIS scale","Oswestry questionnaire","Neck Disability Index questionnaire","Sexual Satisfaction Scale for Women questionnaire","Female Sexual Function Index questionnaire","IEF-5 male sex life assessment questionnaire","Katz scale (ADL - Activities of Daily Living)","Lawton scale - IADL (basic activities of daily living)","WHOQOL-BREF questionnaire","Insomnia Severity Index","body weight using Tanita BC-418 MA device"],"hasResults":false,"conditionSlugs":["stroke","endometriosis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: tDSC stimulation for Stroke","inPlainEnglish":"The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients. And the impact of tDCS stimulation on patients' quality of life.","whoItsFor":["Ages 18 Years to 90 Years","Neurological patients","impairment of upper and lower limb function"],"whoShouldSkip":["no written consent to participate in the study","Gynaecological patients","who can join:","women with selected gynaecological conditions (endometriosis, painful menstruation, dyspareunia, polycystic ovary syndrome) with no treatment other than tDCS stimulation"],"whatHappens":"If you join, the listed intervention(s) are tDSC stimulation. The registry lists allocation as na. The aim of the study is to test the effect of tDCS stimulation on upper and lower limb function in neurological patients and to reduce pain in gynaecological patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Poznan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.789Z"},{"nctId":"NCT06892054","title":"Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma","officialTitle":"Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocarcinoma With KRAS p.G12C Mutation","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)","sponsorClass":"OTHER","summary":"The main objective of this trial is to evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.","conditions":["Pancreatic Adenocarcinoma"],"keywords":["Pancreatic","sotorasib","TTD-24-01","KRASG12C"],"interventions":[{"type":"DRUG","name":"Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days)"}],"enrollment":15,"startDate":"2025-08-08","completionDate":"2030-08-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\) Willing and able to provide informed consent. 2) Men or women aged ≥ 18 years old. 3) Using effective contraceptive measures or sexual abstinence during the treatment, up to 7 days after the last dose of sotorasib, for at least 6 months after the last dose of gem/nab-P and for 15 months after the last dose of mFOLFIRINOX for woman of childbearing age and 12 months after stopping mFOLFIRINOX for men:\n\n* Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate \\[e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner\\])\n* Male agreeing to use condoms or having a partner who is using a highly efficient method of contraception as described above 4) Pathologically confirmed treatment-naïve of locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation assessed by means of a IVDR compliant test) 5) Measurable disease per RECIST 1.1 criteria. 6) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 7) Life expectancy \\> 3 months, in the opinion of the investigator. 8) Adequate hematologic, renal and hepatic organ function, defined as the following within 10 days prior study inclusion:\n* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)\n* Hemoglobin ≥ 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Platelet count ≥ 100 x 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)\n* Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis\n* Serum bilirubin ≤ 1.5 x ULN\n* International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR\n* Creatinine clearance ≥ 30 mL/min (estimated by Cockcroft-Gault equation) 9) Ability to take oral medications and willing to record daily adherence to investigational product.\n\nExclusion Criteria:\n\n1. Patients with resectable or borderline resectable pancreatic cancer.\n2. Known history or positive viral test for human immunodeficiency virus (HIV).\n3. Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX.\n\n5\\) Poor nutritional status (albumin \\<3 g/L or weight loss \\>10% during the last 4 weeks).\n\n6\\) Patients with known active hepatitis (i.e., Hepatitis B or C)\n\n* Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible\n* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA 7) Female: currently pregnant or breast-feeding or who plan to breastfeed while on study though 7 additional days after the last dose of sotorasib and for at least 6 months afterwards after the last dose of gem/nab-P or 15 months after the last dose of mFOLFIRINOX.\n\n  8\\) Myocardial infarction within 6 months of study Day 1, symptomatic congestive heart failure (New York Heart Association \\> class II), unstable angina, or cardiac arrhythmia requiring medication 9) Prior anti-tumor treatment for metastatic or locally advanced pancreatic adenocarcinoma\\*. Prior chemotherapy or radiotherapy in the adjuvant or neoadjuvant setting is acceptable if received \\> 6 months prior to study enrolment\n\n  \\*If initiation of treatment is deemed urgent by the investigator, patients can receive 1st month of Standard of Care (SoC) gem/nab-P (1 cycle) or FOLFIRINOX (2 cycles) during screening. This first month of gem/nab-P or FOLFIRINOX is not a requirement of the study and is not part of this clinical study 10) Active infection requiring antibiotics within 1 weeks of study enrollment. 11) Other malignancy unless curatively treated with no evidence of disease for ≥2 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, and/or ductal carcinoma in situ.\n\n  12\\) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication.\n\n  13\\) History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis.\n\n  14\\) Presence of any condition that, in the opinion of the investigator, renders the patient at high risk from treatment complications or might affect the interpretation of the results of the study.\n\n  15\\) Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to patient safety, in the opinion of the investigator.\n\n  16\\) Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures at a frequency greater than monthly. Patients with PleurX catheters or intraperitoneal drainage catheters in place may be considered for the study with Medical Monitor approval.\n\n  17\\) Major surgery within 4 weeks of study Day 1 18) Prior/concomitant therapy:\n* Previous treatment with a KRASG12C inhibitor\n* Use of warfarin. Other anticoagulation may be allowed\n* Use of known cytochrome P450 (CYP) 3A4 sensitive substrates and P-glycoprotein (P-gp) substrates (with a narrow therapeutic window), within 14 days or 5 half-lives of the drug or its major active metabolite, whichever is longer, prior to study Day 1 (see examples of sensitive substrates and P-glycoprotein substrates in Appendix A) except for those investigational treatments administered as part of the study scheme that will be subject to specific PK analysis.\n* Use of strong inducers of CYP3A4 (including herbal supplements such as St John's wort) within 14 days or 5 half-lives (whichever is longer) prior to study Day 1 (see examples of strong inducers of CYP3A4 in Appendix A)\n* Live attenuated vaccines (against yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus and influenza), within 30 days prior of the first dose of study treatment.\n* Brivudine-based treatments within 4 weeks before treatment with 5-fluorouracil. 19) Patient has known sensitivity to any of the products or components to be administered during the study.\n\n  20\\) History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.","locations":[{"facility":"Sainte Catherine - Institut Avignon Provence","city":"Avignon","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Besançon - Hôpital Jean Minjoz","city":"Besançon","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Brest - Hôpital Morvan","city":"Brest","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu de Lille - Claude Huriez","city":"Lille","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Léon Berard","city":"Lyon","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Bordeaux - Hôpital Haut Lévêque","city":"Pessac","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Poitiers","city":"Poitiers","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Reims - Hôpital Robert Debré","city":"Reims","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Toulouse","city":"Toulouse","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Paul-Brousse","city":"Villejuif","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Miguel Servet","city":"Zaragoza","state":"Aragon","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínic","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall D'Hebron","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català D'Oncologia L'Hospitalet (Ico)","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marqués de Valdecilla","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Reina Sofía","city":"Córdoba","state":"Córdoba","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Donostia-Donostia Unibertsitate Ospitalea","city":"Donostia / San Sebastian","state":"Guipúzcoa","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Marañón","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Regional de Málaga","city":"Málaga","state":"Málaga","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario de Navarra","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complexo Hospitalario Universitario de Ourense","city":"Ourense","state":"OURENSE","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Central de Asturias","city":"Oviedo","state":"Principality of Asturias","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Salamanca","city":"Salamanca","state":"SALAMANCA","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario de Valencia","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Grupo de Tratamiento de los Tumores Digestivos","phone":"+034 913 788 275","email":"secretariattd@ttdgroup.org"}],"primaryOutcomes":["To evaluate the safety and tolerability of sotorasib combined with first-line chemotherapy for locally advanced or metastatic pancreatic adenocarcinoma harboring KRAS p.G12C mutation."],"hasResults":false,"conditionSlugs":[],"drugSlugs":["sotorasib"],"locationSlugs":["avignon-france","besan-on-france","brest-france","lille-france","lyon-france","pessac-france","poitiers-france","reims-france","toulouse-france","villejuif-france","zaragoza-spain","barcelona-spain","santander-spain","c-rdoba-spain","donostia-san-sebastian-spain","madrid-spain","m-laga-spain","pamplona-spain","ourense-spain","oviedo-spain","salamanca-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days) for Pancreatic Adenocarcinoma","inPlainEnglish":"The main objective of this trial is to measure the whether it is safe and how hard side effects are to live with of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.","whoItsFor":["Ages 18 Years to any","Female of childbearing potential using a highly effective method of contraception (i.e., a method with less than 1% failure rate \\[e.g., sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomized partner\\])","Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility)","Hemoglobin ≥ 9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility)","Platelet count ≥ 100 x 109/L (without transfusion within 2 weeks of laboratory test used to determine eligibility)","Aspartate aminotransferase (AST) and ALT ≤ 2.5 times the upper limit of normal (ULN) or ≤5 times if liver metastasis","Serum bilirubin ≤ 1.5 x ULN","International normalized ratio (INR) ≤ 1.5 x ULN. Prothrombin time (PT) ≤ 1.5 x ULN may be used instead of INR for sites whose laboratory do not report INR"],"whoShouldSkip":["Patients with resectable or borderline resectable pancreatic cancer","Known history or positive viral test for human immunodeficiency virus (HIV)","Peripheral sensory neuropathy. 4 )Proven complete dihydropyrimidine dehydrogenase (DPD) deficiency for patients that will be treated with mFOLFIRINOX","5\\) Poor nutritional status (albumin \\<3 g/L or weight loss \\>10% during the last 4 weeks)","6\\) Patients with known active hepatitis (i.e., Hepatitis B or C)","Active hepatitis B virus (HBV) is defined by a known positive HBV surface antigen (HBsAg) result. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody and absence of HBsAg) are eligible","12\\) Significant gastrointestinal disorder that results in significant malabsorption, requirement for IV alimentation, or inability to take oral medication"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib, 960 mg, oral daily dose for 4 weeks (28 days). The registry lists allocation as na. The main objective of this trial is to measure the whether it is safe and how hard side effects are to live with of sotorasib combined with first-line chemotherapy for advanced pancreatic adenocarcinoma harboring KRAS p.G12C mutation.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.972Z"},{"nctId":"NCT06892704","title":"Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.","officialTitle":"Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:\n\n1. Does obstruction of the olfactory cleft predict return of the sense of smell?\n2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?\n\nParticipants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.","conditions":["Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)","Smell Loss"],"keywords":["Dupilumab","Chronic Rhinosinusitis with Nasal Polyps","Smell Loss","Electrophysiology"],"interventions":[{"type":"DRUG","name":"Dupilumab - Standard Dose"}],"enrollment":30,"startDate":"2025-05-01","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"* Well documented history of CRSwNP\n* BSIT age/sex classified as \"abnormal\" score\n* Self-reported stable olfactory deficit of moderate to severe quality \\> 3 months\n* Prior endoscopic sinus surgery \\>3 months, \\<10 years prior","locations":[{"facility":"Northwestern University Feinberg School of Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Coordinator","phone":"312 6958182","email":"aditi.agarwal@northwestern.edu"},{"name":"Bruce Tan, MD","phone":"312 6958182","email":"btan@nm.org"}],"primaryOutcomes":["Status change of the Brief Smell Identification Test"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["dupilumab"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: testing Dupilumab - Standard Dose for Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to 65 Years","Well documented history of CRSwNP","BSIT age/sex classified as \"abnormal\" score","Self-reported stable olfactory deficit of moderate to severe quality \\> 3 months","Prior endoscopic sinus surgery \\>3 months, \\<10 years prior"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.714Z"},{"nctId":"NCT06895473","title":"Intrathecal Cytarabine, Methotrexate, and Hydrocortisone for the Prevention of High-Grade Chimeric Antigen Receptor T-Cell-Associated Neurotoxicity Syndrome","officialTitle":"A Phase 2 Study of Prophylactic IT Chemotherapy to Prevent High-Grade Chimeric Antigen Receptor (CAR) T-Cell-Associated Neurotoxicity Syndrome","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"OHSU Knight Cancer Institute","sponsorClass":"OTHER","summary":"This phase II trial tests how well cytarabine (Ara-C), methotrexate, and hydrocortisone given between the spinal cord and the membranes that protect it (intrathecal \\[IT\\]) works in preventing high-grade immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving chimeric antigen receptor (CAR) T-cell therapy. ICANS is a challenging complication of CAR T-cell therapy that causes neurological effects varying from mild headaches or temporary confusion to hallucinations, swelling in the brain, and seizures. Between 20%-70% of patients receiving CAR T-cell therapy show symptoms of neurotoxicity.","conditions":["Hematopoietic and Lymphatic System Neoplasm"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cytarabine"},{"type":"PROCEDURE","name":"Lumbar Puncture"},{"type":"DRUG","name":"Methotrexate"},{"type":"DRUG","name":"Therapeutic Hydrocortisone"}],"enrollment":26,"startDate":"2025-06-04","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions\n* Age ≥ 18 years. All genders, races, and ethnic groups will be included\n* Must be receiving SOC Yescarta® or Tecartus® in the inpatient setting\n* Agree to adhere to institutional guidelines for contraception during the first 30 days post CAR-T\n\n  * Rationale for eligibility criteria based on contraception and pregnancy (both participants and partners of a sperm-producing participant): It shall be known to all participants that the effects of CAR-T or IT chemotherapy on the developing human fetus are unknown. For this reason, persons of reproductive potential must agree to use adequate contraception. Should a participant or participant's sexual partner become pregnant or suspect a pregnancy while participating in this study, the individual should inform their treating physician immediately\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n* Platelet count \\> 50,000/mm\\^3 (μL)\n* Adequate coagulation tests including international normalized ratio (INR) \\< 1.6 and fibrinogen \\> 100\n\nExclusion Criteria:\n\n* Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy\n\n  * History or presence of CNS disorder such as seizure disorder, transverse myelitis, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n* Known history of hypersensitivity to IT chemotherapy\n* Subject has a contraindication to LP including:\n\n  * Presence of a posterior fossa mass\n  * Skin infection near puncture site\n  * Uncorrected bleeding diathesis\n  * Suspicion of increased intracranial pressure\n  * Acute spinal cord trauma\n* Subject is receiving an antiplatelet and/or anticoagulant that cannot be held prior to LP according to best available evidence\n* Known bleeding disorders\n* Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgement, make the participant inappropriate for study participation or would put the participant at risk","locations":[{"facility":"OHSU Knight Cancer Institute","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of American Society for Transplantation and Cellular Therapy (ASTCT) ≥ grade 3 immune-effector cell associated neurotoxicity syndrome (ICANS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["car-t"],"locationSlugs":["portland-oregon"],"enrichment":{"headline":"Phase 2: testing Cytarabine for Hematopoietic and Lymphatic System Neoplasm","inPlainEnglish":"This phase II trial tests how well cytarabine (Ara-C), methotrexate, and hydrocortisone given between the spinal cord and the membranes that protect it (intrathecal \\[IT\\]) works in preventing high-grade immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving chimeric antigen receptor (CAR) T-cell therapy. ICANS is a challenging complication of CAR T-cell therapy that causes neurological effects varying from mild headaches or temporary confusion to hallucinations, swelling in the brain, and seizures.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years. All genders, races, and ethnic groups will be included","Must be receiving SOC Yescarta® or Tecartus® in the inpatient setting","Agree to adhere to institutional guidelines for contraception during the first 30 days post CAR-T","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2","Platelet count \\> 50,000/mm\\^3 (μL)","Adequate coagulation tests including international normalized ratio (INR) \\< 1.6 and fibrinogen \\> 100"],"whoShouldSkip":["Active/concurrent diagnosis of any central nervous system (CNS) hematologic malignancy","History or presence of CNS disorder such as seizure disorder, transverse myelitis, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement","Known history of hypersensitivity to IT chemotherapy","Subject has a contraindication to LP including:","Presence of a posterior fossa mass","Skin infection near puncture site","Uncorrected bleeding diathesis"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cytarabine, or Lumbar Puncture. The registry lists allocation as na. This phase II trial tests how well cytarabine (Ara-C), methotrexate, and hydrocortisone given between the spinal cord and the membranes that protect it (intrathecal \\[IT\\]) works in preventing high-grade immune effector-associated neurotoxicity syndrome (ICANS) in patients receiving chimeric antigen receptor (CAR) T-cell therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 26 people at Portland. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.398Z"},{"nctId":"NCT06897475","title":"A Study of LY3457263 Compared With Placebo in Participants With Type 2 Diabetes on a Stable Dose of Semaglutide or Tirzepatide","officialTitle":"A Parallel-Group Treatment, Phase 2, Double-Blind Study of Once-Weekly Subcutaneous LY3457263 Compared to Placebo in Participants With Type 2 Diabetes Mellitus on a Stable Dose of Semaglutide or Tirzepatide Who Failed to Achieve HbA1c Goal","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with placebo in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide. Participation in the study will last about 9 months.","conditions":["Type 2 Diabetes"],"keywords":["Obesity","Overweight"],"interventions":[{"type":"DRUG","name":"LY3457263"},{"type":"DRUG","name":"Placebo"}],"enrollment":200,"startDate":"2025-03-28","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have HbA1c ≥7.5% to ≤10.5% at screening\n* Have a body mass index (BMI) of ≥27 kilograms per square meter (kg/m2) at screening\n* Have had a stable body weight for the three months prior to screening\n* On stable treatment dose of one of the following incretins for at least three months prior to screening:\n\n  * Injectable semaglutide (1 and 2 milligram (mg))\n  * Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)\n\nExclusion Criteria:\n\n* Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma\n* Have a prior or planned surgical treatment for obesity\n* Have any of the following cardiovascular conditions within three months prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have used insulin to control blood glucose within the past year (short-term use allowed)\n* Current use of prohibited oral antihyperglycemic medication (OAM) (including but not limited to, Dipeptidyl Peptidase IV Inhibitors (DPP-4i) and meglitinides) may be randomized if the prohibited OAM treatment was discontinued at least 3 months prior to screening\n\n  * If participant has been on stable doses (for at least three months) of up to three permitted OAMs (limited to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors, sulfonylurea, and/or thiazolidinediones (TZD), they are permitted to participate in the study\n* Have taken any medications or alternative remedies for weight loss within three months prior to screening","locations":[{"facility":"Helios Clinical Research - Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolverine Clinical Trials","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oviedo Medical Research","city":"Oviedo","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Balanced Life Health Care Solutions/SKYCRNG","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians Research Associates","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rophe Adult and Pediatric Medicine/SKYCRNG","city":"Union City","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elite Clinical Trials","city":"Rexburg","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigators Research Group","city":"Brownsburg","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Philadelphia","city":"Pennington","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYC Research INC","city":"Long Island City","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond University Medical Center","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southgate Medical Group","city":"West Seneca","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucas Research, Inc.","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shelby Clinical Research","city":"Shelby","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Health Partners-Center for Clinical Research","city":"Dayton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance for Multispecialty Research, LLC","city":"Norman","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research, LLC","city":"Scottdale","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juno Research","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Endocrinology Associates","city":"Mesquite","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Diabetes & Endocrinology, P.A.","city":"Round Rock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Valley Clinical Research","city":"Weslaco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastside Research Associates","city":"Redmond","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research Brampton Endocrinology","city":"Brampton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ecogene-21","city":"Chicoutimi","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winterberry Research Inc.","city":"Hamilton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Viacar Recherche Clinique","city":"Longueuil","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"G A Research Associates","city":"Moncton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bluewater Clinical Research Group Inc.","city":"Sarnia","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maple Leaf Research","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diabetes Heart Research Centre","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fadia El Boreky Medicine","city":"Waterloo","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"InnoDiab Forschung Gmbh","city":"Essen","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Leipzig","city":"Leipzig","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut","city":"Leipzig","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Institut für Diabetesforschung GmbH Münster","city":"Münster","state":"","country":"Germany","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"RED-Institut 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Participation in the study will last about 9 months.","whoItsFor":["Ages 18 Years to 75 Years","Have type 2 diabetes","Have HbA1c ≥7.5% to ≤10.5% at screening","Have a body mass index (body-mass index (BMI)) of ≥27 kilograms per square meter (kg/m2) at screening","Have had a stable body weight for the three months prior to screening","On stable treatment dose of one of the following incretins for at least three months prior to screening:","Injectable semaglutide (1 and 2 milligram (mg))","Injectable tirzepatide (5, 7.5, 10, 12.5 and 15 mg)"],"whoShouldSkip":["Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar coma","Have a prior or planned surgical treatment for obesity","Have any of the following cardiovascular conditions within three months prior to screening:","acute myocardial infarction","cerebrovascular accident (stroke)","unstable angina, or","hospitalization due to congestive heart failure"],"whatHappens":"If you join, the listed intervention(s) are LY3457263, or Placebo. The registry lists allocation as randomized. This study wants to measure the change in hemoglobin A1c (HbA1c) with LY3457263 compared with dummy treatment (placebo) in participants with type 2 diabetes who are not at HbA1c goal when treated with a stable dose of semaglutide or tirzepatide.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at 60 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.724Z"},{"nctId":"NCT06899126","title":"Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer","officialTitle":"A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.","conditions":["Non-small Cell Lung Cancer"],"keywords":["DESTINY","NSCLC"],"interventions":[{"type":"DRUG","name":"Trastuzumab Deruxtecan"},{"type":"DRUG","name":"pembrolizumab"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Platinum Chemotherapy"}],"enrollment":686,"startDate":"2025-10-24","completionDate":"2030-04-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.\n\n   Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Histologically documented non-squamous locally advanced unresectable or metastatic\n\n   NSCLC and meets all of the following criteria:\n\n   Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on the local test results obtained using validated or approved tests as required per local regulation) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting.\n\n   Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if non-squamous NSCLC is the predominant histology. Mixed tumors will be classified based on the predominant cell type.\n4. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose if their disease has progressed at least 6 months after the last dose date of adjuvant/neoadjuvant therapy.\n\n   1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.\n   2. HER2-targeted antibody-based anticancer therapy.\n5. Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.\n\nDetails pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.\n\nExclusion Criteria:\n\n1. Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms must be ruled out for MI. It is highly recommended that the investigator refer such participants for a cardiologic consultation during the Screening Period.\n2. Has a QTc prolongation to \\>480 ms based on the average of the Screening triplicate 12- lead ECG.\n3. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.\n4. Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:\n\n   1. Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion).\n   2. Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis).\n\n   Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen.\n5. Had a prior complete pneumonectomy.","locations":[{"facility":"Alaska Oncology & Hematology, LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orange Coast Memorial Medical Center Fountain Valley","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Cancer Network (LACN)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bay Pines VA Healthcare System","city":"Bay Pines","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lynn Cancer Institute Center","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holy Cross Hospital","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-Florida Hematology & Oncology Centers, P.A.","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global Plantation","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Florida - Weston","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Cancer Institute OneOncology","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Queens Medical Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope and Healing Cancer Services","city":"Hinsdale","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Logan Health Research","city":"Kalispell","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Alliance","city":"Westbury","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FirstHealth Cancer Center","city":"Pinehurst","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Cancer Research Center","city":"Wilson","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabrail Cancer Center","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Charles Health System","city":"Bend","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas M. 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Review"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab","trastuzumab-deruxtecan"],"locationSlugs":["anchorage-alaska","fountain-valley-california","los-angeles-california","santa-rosa-california","bay-pines-florida","boca-raton-florida","fort-lauderdale-florida","orange-city-florida","plantation-florida","weston-florida","atlanta-georgia","honolulu-hawaii","hinsdale-illinois","boston-massachusetts","rochester-minnesota","kalispell-montana","reno-nevada","westbury-new-york","pinehurst-north-carolina","wilson-north-carolina","canton-ohio","bend-oregon","houston-texas","kingwood-texas","spokane-washington","buenos-aires-argentina","ciudad-autonoma-buenos-aires-argentina","c-rdoba-argentina","pergamino-argentina","pilar-argentina","rosario-argentina","san-juan-argentina","edegem-belgium","gilly-belgium","la-louvi-re-belgium","li-ge-belgium","mons-belgium","barretos-brazil","blumenau-brazil","curitiba-brazil","fortaleza-brazil","natal-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","rio-de-janeiro-brazil","salvador-brazil","santo-andr-brazil","sao-jose-rio-preto-brazil","s-o-paulo-brazil","vila-ol-mpia-brazil","concepci-n-chile","santiago-chile","beijing-china","changchun-china","changsha-china","chengdu-china","chongqing-china","guangzhou-china","hangzhou-china","harbin-china","hefei-china","hong-kong-china","jinan-china","jordan-china","linyi-china","nanchang-china","nanjing-china","neijiang-china","shanghai-china","shenyang-china","taiyuan-china","tianjin-china","wuhan-china","xiangyang-china","zhengzhou-china","angers-france","bordeaux-france","boulogne-billancourt-france","bron-france","cr-teil-france","dijon-france","lille-france","lyon-france","marseille-france","montpellier-france","nantes-france","paris-france","saint-herblain-france","suresnes-france","toulouse-france","essen-germany","esslingen-am-neckar-germany","giessen-germany","manheim-germany","nordrhein-westfalen-germany","athens-greece","larissa-greece","neo-faliro-greece","pan-rama-greece","p-trai-greece","piraeus-greece","thessaloniki-greece","hong-kong-hong-kong","shatin-hong-kong","wong-chuk-hang-hong-kong","bangalore-india","bhubaneswar-india","howrah-india","mangalore-india","pune-india","surat-india","bologna-italy","candiolo-italy","fano-italy","genova-italy","livorno-italy","milan-italy","misterbianco-italy","orbassano-italy","roma-italy","varese-italy","verona-italy","hidaka-shi-japan","hirakata-shi-japan","hirosaki-shi-japan","kashiwa-shi-japan","kawasaki-shi-japan","kitakyushu-shi-japan","kumamoto-japan","kurume-shi-japan","matsusaka-shi-japan","okayama-japan","osaka-japan","ta-ku-japan","sakaishi-japan","sapporo-japan","shinjuku-ku-japan","sunto-gun-japan","toon-shi-japan","toyoake-shi-japan","wakayama-japan","yokohama-japan","yonago-shi-japan","jalan-pangkor-malaysia","kuala-lumpur-malaysia","kuantan-malaysia","petaling-jaya-malaysia","mexico-city-mexico","rzesz-w-poland","lisbon-portugal","porto-portugal","bucharest-romania","cluj-napoca-romania","craiova-romania","lasi-romania","otopeni-romania","ploie-ti-romania","cheongju-si-south-korea","goyang-si-south-korea","jinju-south-korea","seongnam-south-korea","seoul-south-korea","suwon-south-korea","a-coru-a-spain","barcelona-spain","burgos-spain","castellion-spain","las-palmas-de-gran-canaria-spain","lugo-spain","madrid-spain","m-laga-spain","oviedo-spain","santiago-de-compostela-spain","seville-spain","kaohsiung-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","bangkok-thailand","dusit-thailand","hat-yai-thailand","laksi-thailand","rajathevee-thailand","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","eastbourne-united-kingdom","london-united-kingdom","londonderry-united-kingdom","nottingham-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Trastuzumab Deruxtecan for Non-small Cell Lung Cancer","inPlainEnglish":"This clinical trial is designed to assess the how well it works and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.","whoItsFor":["Ages 18 Years to any","Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures","Sign and date the Optional PGx ICF (included in the Main ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable","Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old","Histologically documented non-squamous locally advanced unresectable or metastatic","NSCLC and meets all of the following criteria:","Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I","HER2-targeted antibody-based anticancer therapy"],"whoShouldSkip":["Has a QTc prolongation to \\>480 ms based on the average of the Screening triplicate 12- lead ECG","Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening","Has clinically severe pulmonary compromise resulting from intercurrent, pulmonary illnesses including, but not limited to:","Any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion)","Any auto immune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis)","Severe conditions are those defined as impacting daily activities and/or requiring use of supplemental oxygen","Had a prior complete pneumonectomy"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab Deruxtecan, pembrolizumab, or Pemetrexed. The registry lists allocation as randomized. This clinical trial is designed to assess the how well it works and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS \\<50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 686 people at 246 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.351Z"},{"nctId":"NCT06900595","title":"Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescents and Adults With Advanced Adrenocortical Cancer","officialTitle":"A Phase II Study of Cabozantinib in Combination With Cemiplimab (Cabo-Cemiplimab) Versus Cabozantinib Alone in Adolescents and Adults With Advanced Adrenocortical Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib with cemiplimab may kill more tumor cells in patients with locally advanced unresectable or recurrent/metastatic adrenocortical cancer.","conditions":["Locally Advanced Adrenal Cortical Carcinoma","Metastatic Adrenal Cortical Carcinoma","Recurrent Adrenal Cortical Carcinoma","Stage III Adrenal Cortical Carcinoma AJCC v8","Stage IV Adrenal Cortical Carcinoma AJCC v8","Unresectable Adrenal Cortical Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Cabozantinib"},{"type":"BIOLOGICAL","name":"Cemiplimab"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"}],"enrollment":48,"startDate":"2026-02-22","completionDate":"2029-06-02","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma\n* STEP 1: Locally advanced unresectable or recurrent/metastatic disease\n* STEP 1: Evaluable disease as defined by RECIST v 1.1\n* STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed.\n\n  * Note: Combination etoposide, doxorubicin, cisplatin, and mitotane (EDP-M) is considered 1 line of therapy. For patients who received mitotane ≤ 6 months prior to registration, mitotane should be discontinued 28 days prior to study registration AND a mitotane level must be documented to be \\< 2 mg/L prior to registration. Patients who have received mitotane within 6 months of enrollment and who have mitotane levels ≥ 2 mg/L will not be eligible to enroll\n* STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy\n* STEP 1: Prior external beam radiation therapy (any area radiated within a month prior to study registration cannot be used as an index lesion and only growth outside of the radiation field can be considered for disease progression), systemic cytotoxic chemotherapy, targeted therapies will be allowed, as long as not administered within 14 days before study registration, and provided any acute treatment-related associated toxicities have recovered to ≤ grade 1 except for alopecia, peripheral neuropathy or other residual toxicities that are not deemed clinically significant\n* STEP 1: Potential trial participants should have recovered from clinically significant adverse events, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment\n* STEP 1: Age 12 years and above; and BSA ≥ 1.2m\\^2\n* STEP 1:\n\n  * Eastern Cooperative Oncology Group (ECOG) performance 0 - 2 (age 18 and above); or\n  * Patients 12 to \\<16 years of age will be assessed by the Lansky scale and should have a score ≥ 50; or\n  * Patients ≥ 16 to \\<18 years of age will be assessed by the Karnofsky scale, and should have a score ≥ 50\n* STEP 1: Absolute neutrophil count (ANC) ≥ 1,000/mcL without colony stimulating factor support within 2 weeks prior\n\n  * Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory\n* STEP 1: Platelet count ≥ 100,000/mcL\n\n  * Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory\n* STEP 1: Hemoglobin ≥ 8 g/dL\n\n  * Transfusion support is allowed if ≥ 7 days from obtaining required initial laboratory\n* STEP 1: Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n\n  * For patients with known Gilbert's disease, bilirubin ≤ 3 mg/dL\n* STEP 1: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x upper limit of normal (ULN)\n* STEP 1: Random Urine Creatinine Ratio (UPCR) ≤ 1 mg/mg\n* STEP 1: Calculated (Calc.) creatinine clearance ≥ 30 mL/min\n* STEP 1: Mitotane level \\< 2 mg/L\\*\n\n  * Only applicable for patients who have received mitotane ≤ 6 months prior to registration\n* STEP 1: Must have assessment of adrenal steroid production within 3 months prior to registration as patients will be stratified based on corticosteroid production\n\n  * Patients will be classified as corticosteroid producing if random plasma adrenocorticotropic hormone (ACTH) is \\< 20 pg/mL plus random serum cortisol is \\> 20 mcg/dL in the absence of anti-cortisol therapy. Patients already on anti-cortisol therapy will be classified as having corticosteroid producing tumors regardless of their plasma ACTH and serum cortisol levels, as these levels can be affected by anti-cortisol therapy\n* STEP 1: Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects based on animal reproduction studies. Therefore, for women of childbearing potential only, a negative urine or serum pregnancy test, per institution standard, done ≤ 14 days prior to registration is required\n* STEP 1: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional within 28 days of registration. To be eligible for this trial, patients should be class II or better\n* STEP 1: No known history of congenital long QT syndrome\n* STEP 1: No known history of myocarditis\n* STEP 1: No myocardial infarction (MI) or unstable angina within 6 months of registration\n* STEP 1: No clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding within 6 months of registration including, but not limited to: active peptic ulcer, known endoluminal metastatic lesion(s) with history of bleeding, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation\n* STEP 1: No history of gastrointestinal (GI) perforation within 6 months of registration\n* STEP 1: No known tumor with invasion into the GI tract from the outside causing increased risk of perforation or bleeding within 28 days of registration\n* STEP 1: No current radiologic or clinical evidence of pancreatitis\n* STEP 1: No history of clinically significant non-healing wounds or ulcers within 28 days of registration\n* STEP 1: No uncontrolled hypertension within 14 days of registration (defined as sustained systolic blood pressure (SBP) ≥ 150 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg despite optimal medical management)\n* STEP 1: No known endobronchial lesions involving the main or lobar bronchi and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage. (CT with contrast is recommended to evaluate such lesions.). No hemoptysis greater than ½ teaspoon (2.5 mL) or any other signs of pulmonary hemorrhage within the 3 months prior to registration\n* STEP 1: No history of pneumonitis\n* STEP 1: No known tumor invading or encasing any major blood vessels\n* STEP 1: No history of fracture within 28 days of registration\n* STEP 1: No known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks after major surgery (e.g., removal or biopsy of brain metastasis) before registration. Eligible patients must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment\n* STEP 1: Major surgery (e.g., laparoscopic nephrectomy, GI surgery, within 2 weeks before registration. Minor surgeries within 10 days before registration. Patients with clinically relevant ongoing complications from prior surgery are not eligible\n* STEP 1: Verbalizes the ability to swallow oral tablet formulation\n* STEP 1: No history of allergic reaction attributed to compounds of similar chemical or biological composition to cabozantinib\n* STEP 1: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen will be eligible\n* STEP 1: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial\n* STEP 1: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 1: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* STEP 1: No active autoimmune disease: or history of autoimmune disease that might recur, and which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. These include but are not limited to patients with a history of:\n\n  * immune related neurologic disease,\n  * multiple sclerosis,\n  * autoimmune (demyelinating) neuropathy,\n  * Guillain-Barre syndrome (GBS), myasthenia gravis,\n  * systemic autoimmune disease such as systemic lupus erythematosus (SLE),\n  * connective tissue diseases,\n  * scleroderma, inflammatory bowel disease (IBD),\n  * Crohn's, ulcerative colitis,\n  * patients with a history of toxic epidermal necrolysis (TEN),\n  * Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease,\n  * Patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible,\n  * Patients with rheumatoid arthritis and other arthropathies, Sjögren's syndrome, and psoriasis controlled with topical medication and patients with only positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* STEP 1: No steroid use \\> 10 mg prednisone equivalents daily. A brief course of corticosteroids for prophylaxis or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted, as is steroid pre-medication for contrast allergy\n* STEP 1: Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study\n* STEP 1: Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment\n* STEP 1: Herbal supplements and traditional Chinese medicines are not allowed\n* STEP 1: Active treatment with coumarin agents (e.g., warfarin), direct thrombin inhibitors (e.g., dabigatran), direct Xa inhibitor betrixaban or platelet inhibitors (e.g., clopidogrel) within 5 days of registration. Allowed use of anticoagulants include: prophylactic use of low-dose aspirin for cardio-protection (per local applicable guidelines) and low-dose low molecular weight heparins (LMWH), therapeutic doses of LMWH or anticoagulation with direct factor Xa inhibitors rivaroxaban, edoxaban, apixaban. Also use of anticoagulants is allowed in patients with known brain metastases who are on a stable dose of the anticoagulant for at least 1 week prior to registration without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor\n* STEP 2 (CROSSOVER): Patients must have demonstrated radiographic progression of disease on cabozantinib monotherapy (Arm A) per RECIST version 1.1 criteria\n\n  * Patients must cross-over to Arm C within 4 weeks (+/- 1 week) after radiographic documented progression and do not need to have a repeat radiographic assessment prior to starting cabozantinib and cemiplimab (REGN2810). The progression CT may serve as eligibility for crossover and as the baseline tumor measurement\n* STEP 2 (CROSSOVER): Patients that were discontinued on cabozantinib, or currently meet criteria for discontinuation of cabozantinib due to toxicity are not eligible to cross-over.\n\n  * Note: Patients who underwent dose reduction of cabozantinib during treatment on Arm A will not re-escalate dose at or after cross-over to Cabo-Cemiplimab (REGN2810) (Arm B)\n* STEP 2 (CROSSOVER): Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative serum or urine pregnancy test done ≤ 14 days prior to re-registration is required","locations":[{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Children's Hospital","city":"Madera","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lurie Children's Hospital-Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Kishwaukee","city":"DeKalb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Delnor","city":"Geneva","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Glenview Outpatient Center","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Grayslake Outpatient Center","city":"Grayslake","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Lake Forest Hospital","city":"Lake Forest","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Oak Brook","city":"Oak Brook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Orland Park","city":"Orland Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hospital East","city":"Shiloh","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine Cancer Center Warrenville","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UI Health Care Mission Cancer and Blood - 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Montlake","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Progression free survival (PFS)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","la-jolla-california","madera-california","aurora-colorado","jacksonville-florida","chicago-illinois","danville-illinois","dekalb-illinois","effingham-illinois","geneva-illinois","glenview-illinois","grayslake-illinois","lake-forest-illinois","mattoon-illinois","normal-illinois","oak-brook-illinois","orland-park-illinois","shiloh-illinois","urbana-illinois","warrenville-illinois","ankeny-iowa","carroll-iowa","clive-iowa","des-moines-iowa","fort-dodge-iowa","waukee-iowa","boston-massachusetts","ann-arbor-michigan","rochester-minnesota","city-of-saint-peters-missouri","creve-coeur-missouri","kansas-city-missouri","springfield-missouri","st-louis-missouri","bellevue-nebraska","omaha-nebraska","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","uniondale-new-york","cary-north-carolina","durham-north-carolina","raleigh-north-carolina","columbus-ohio","oklahoma-city-oklahoma","pittsburgh-pennsylvania","boiling-springs-south-carolina","columbia-south-carolina","easley-south-carolina","greenville-south-carolina","greer-south-carolina","seneca-south-carolina","memphis-tennessee","austin-texas","dallas-texas","fort-worth-texas","richardson-texas","san-antonio-texas","richmond-virginia","seattle-washington"],"enrichment":{"headline":"Phase 2: testing Cabozantinib for Locally Advanced Adrenal Cortical Carcinoma","inPlainEnglish":"This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib is in a class of medications called tyrosine kinase inhibitors.","whoItsFor":["Ages 12 Years to any","STEP 1: Patients must have documented histologically or cytologically confirmed adrenocortical carcinoma","STEP 1: Locally advanced unresectable or recurrent/metastatic disease","STEP 1: Evaluable disease as defined by RECIST v 1.1","STEP 1: Up to 3 prior lines of systemic therapy will be allowed in the unresectable/recurrent/metastatic setting. Treatment naïve patients will be allowed","STEP 1: No prior treatment with cabozantinib or other cMET inhibitors, or anti-CTLA-4, or anti-PD-1/PD-L1 therapy","STEP 1: Potential trial participants should have recovered from clinically significant side effects, and wound healing is clinically adequate of their most recent therapy/intervention prior to enrollment","STEP 1: Age 12 years and above; and BSA ≥ 1.2m\\^2"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Cabozantinib, or Cemiplimab. The registry lists allocation as randomized. This phase II trial compares the effect of giving cabozantinib with or without cemiplimab in patients with adrenocortical cancer that has spread to nearby tissue or lymph nodes (locally advanced), and that cannot be removed by surgery (unresectable) or that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 48 people at 81 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:35.064Z"},{"nctId":"NCT06901531","title":"A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer","officialTitle":"A Phase 3, Double-blind, Randomized Study of Zolbetuximab in Combination With Pembrolizumab and Chemotherapy (CAPOX or mFOLFOX6) in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma in Participants Whose Tumors Are HER2-negative, Claudin (CLDN) 18.2-positive and Programmed Death-ligand 1 (PD-L1)-Positive","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Astellas Pharma Global Development, Inc.","sponsorClass":"INDUSTRY","summary":"Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. Certain stomach and GEJ cancers may be treated with immunotherapy, which helps the body's immune system fight cancer. This study will give more information about how well zolbetuximab works when given with an immunotherapy medicine called pembrolizumab and chemotherapy. In this study, adults with stomach cancer or GEJ cancer will either be given zolbetuximab with pembrolizumab and chemotherapy or a placebo with pembrolizumab and chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it.\n\nThe main aim of the study is to check how long people with stomach cancer and GEJ cancer live after treatment with zolbetuximab with pembrolizumab and chemotherapy compared to placebo with pembrolizumab and chemotherapy.\n\nAdults with locally advanced unresectable or metastatic stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample (biopsy) of their cancer will have the Claudin 18.2 protein, PD-L1 protein, and be HER2-negative. They may have been previously treated with certain standard therapies. People can also take part if they need to take medicines like steroids to suppress their immune system. They cannot take part if they have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.\n\nThe study treatments are either zolbetuximab with pembrolizumab and chemotherapy, or placebo with pembrolizumab and chemotherapy. People who take part will receive just 1 of the study treatments by chance. The people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in 6-week (42-day) cycles. The study treatment is mainly given to people slowly through a tube into a vein. This is called an infusion. People will receive study treatment as follows: Zolbetuximab or placebo: 1 infusion every 2 or 3 weeks (2 or 3 infusions in a cycle) together with: Chemotherapy (1 of the following types of chemotherapy): 1. CAPOX (capecitabine and oxaliplatin): 1 infusion of oxaliplatin every 3 weeks (2 infusions in a cycle). People will also take 1 tablet of capecitabine twice a day for 2 weeks (14 days) at the start of each cycle (Day 1) and again in the middle of each cycle (Day 22). After 8 study treatments people will receive capecitabine only. 2. Modified FOLFOX6 or mFOLFOX6 (5-fluorouracil, folinic acid and oxaliplatin): 1 infusion every 2 weeks (3 infusions in a cycle). After 12 study treatments people will receive folinic acid and fluorouracil only, instead of mFOLFOX6. Pembrolizumab: 1 infusion every 3 or 6 weeks (1 or 2 infusions in a cycle). People can be in the study and will receive study treatment until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People may receive pembrolizumab for up to 2 years. People will visit the clinic on certain days to receive their study treatment and have health checks. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample if they stop treatment because their cancer has worsened. People will visit the clinic after they stop their study treatment. People will be asked about any medical problems and will have a health check. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. They will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.","conditions":["Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer","Metastatic Gastric Adenocarcinoma or Cancer","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma"],"keywords":["Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer","Locally Advanced Unresectable Gastric Adenocarcinoma Cancer","Metastatic Gastric Adenocarcinoma Cancer","Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma","Claudin 18.2","PD-L1","Human epidermal growth factor receptor 2 (HER2) Negative","zolbetuximab"],"interventions":[{"type":"DRUG","name":"zolbetuximab"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Folinic acid (leucovorin or local equivalent)"},{"type":"DRUG","name":"5-fluorouracil (5-FU)"},{"type":"DRUG","name":"Placebo"}],"enrollment":500,"startDate":"2025-05-22","completionDate":"2028-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1.\n* Participant has predicted life expectancy ≥ 12 weeks.\n* Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a woman of child bearing potential (WOCBP)\n  * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions.\n  * Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 5 half-lives (at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study interventions).\n  * Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final administration of oxaliplatin and for 6 months after final administration of all other study interventions.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 6 months after final investigational study intervention administration.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final investigational study intervention administration.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final investigational study intervention administration\n* Participant has a Human Epidermal Growth Factor Receptor 2 (HER2) -negative tumor.\n* Participant's tumor expresses Claudin18.2 (CLDN18.2) in ≥ 75% of tumor cells demonstrating moderate to strong membranous staining as determined by central immunohistochemistry (IHC) testing.\n* Participant's tumor expresses Programmed death ligand (PD-L1) combined positive score (CPS) ≥ 1 as determined by central IHC testing.\n* Participants with known microsatellite instability-high or mismatch repair deficient status may enroll as long as they meet the PD-L1 positivity criteria.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used.\n* Participant agrees not to participate in another interventional study while receiving study intervention in the present study.\n\nExclusion Criteria:\n\n* Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting.\n* Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation.\n* Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis.\n* Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer.\n* Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.\n\n  * For participants who are negative for HBsAg, but hepatitis B core antibody (HBcAb) positive, a hepatitis B DNA test will be performed and if positive the participant will be excluded.\n  * Participants with positive Hepatitis C virus (HCV) serology, but negative HCV RNA test results are eligible.\n  * Participants treated for HCV with undetectable viral load results are eligible.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant has active autoimmune disease that has required systemic treatment within the past 3 months prior to randomization. Participants with stable autoimmune disease who are receiving physiologic replacement doses of hydrocortisone or its equivalent are allowed.\n* Participant has a clinically significant disease or comorbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has another malignancy for which treatment is required.\n* Participant has known complete Dihydropyrimidine Dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has known peripheral neuropathy \\> grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the participant ineligible).\n* Participant has sinusoidal obstruction syndrome, formerly known as veno-occlusive disease, if present, should be stable or improving.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * History of clinically significant ventricular arrhythmias (i.e., sustained; ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).\n  * QTc interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * History or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (participants with rate controlled atrial fibrillation for \\> 1 month prior to randomization are eligible).\n* Participant has ongoing or previous interstitial lung disease, active diverticulitis or peptic ulcerative disease, or solid organ or stem cell transplant or other uncontrolled or clinically significant medical disorders.\n* Participant has type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.\n* Participant has received prior systemic chemotherapy and/or immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, except for a maximum of 1 treatment course of mFOLFOX6 (day 1 to 14) or CAPOX (day 1 to 21) with or without pembrolizumab. However, participants may have received either neo-adjuvant or adjuvant chemotherapy, immunotherapy or other systemic anticancer therapies as long as their disease progression occurred at least 6 months after the last dose. Participant who has received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization is allowed.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to randomization. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single-dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use is allowed.\n* Participant has had major surgical procedure ≤ 28 days before randomization and has not completely recovered from the surgical procedure ≤ 14 days before randomization.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma ≤ 14 days prior to randomization and has NOT recovered from any related toxicity. 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Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive).","whoItsFor":["Ages 18 Years to any","Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma","Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization","Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1","Participant has predicted life expectancy ≥ 12 weeks","Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab","Female participant is not pregnant and at least 1 of the following conditions apply:","Not a woman of child bearing potential (WOCBP)"],"whoShouldSkip":["Participant has prior severe allergic reaction or intolerance to zolbetuximab or other monoclonal antibodies, pembrolizumab, mFOLFOX6 or CAPOX","Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent recurrent vomiting","Participant has significant gastric bleeding and/or untreated gastric ulcers that would preclude the participant from participation","Participant has unresolved pneumonitis or history of non-infectious pneumonitis such as immune-related pneumonitis, radiation induced pneumonitis","Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ cancer","Participant has a known history of a positive test for Human Immunodeficiency Virus (HIV) infection or known active Hepatitis B Surface Antigen (positive HBsAg) or hepatitis C infection. 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Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.353Z"},{"nctId":"NCT06914128","title":"A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors","officialTitle":"A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of BAY 3713372, a Novel 2nd Generation PRMT5 Inhibitor, in Participants With MTAP-deleted Solid Tumors.","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Bayer","sponsorClass":"INDUSTRY","summary":"The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells.\n\nThe main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors.\n\nFor this, the researchers will study and analyze:\n\n* the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity.\n* the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose.\n* the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses.\n* the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses.\n\nOther than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse.\n\nThe study participants will take part in one of the eight distinct groups or \"intervention cohorts\" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase.\n\nParticipants may take the study treatment as long as they benefit from the treatment without any severe medical problems.\n\nParticipants will visit the study site:\n\n* at least twice before the treatment starts\n* multiple times when they start taking the treatment\n* once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason\n\nDuring the study, the doctors and their study team will:\n\n* check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram\n* check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan\n* take tumor samples\n\nThe study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.","conditions":["MTAP-deleted Solid Tumors"],"keywords":["Solid Tumors","Non-small cell lung cancer","NSCLC","Pancreatic adenocarcinoma","PDAC","Glioblastoma","GBM"],"interventions":[{"type":"DRUG","name":"BAY 3713372"}],"enrollment":450,"startDate":"2025-03-21","completionDate":"2029-06-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must be ≥ 18 years old of age, or the legal age of consent in the jurisdiction of the country in which the study takes place, at the time of signing the informed consent.\n* At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).\n* Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Previous additional cancer other than the one evaluated in this study within the past 2 years except for basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder tumors, localized prostate cancer or other tumors that in the opinion of the investigator, are considered cured or not immediately life-threatening, and will not interfere with the scientific goals of this study.\n* A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval \\>450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion.\n* Cardiac history comprising:\n\n  * History of congestive heart failure Class \\>II according to the New York Heart Association Functional Classification.\n  * Myocardial infarction less than 6 months before the start of study intervention.\n  * Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers.\n* Unstable angina within 4 weeks before start of study intervention.","locations":[{"facility":"UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital","city":"Birmingham","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope - Duarte Cancer Center","city":"Duarte","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCLA Health Bowyer Oncology Center","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCSF Helen Diller Medical Center at Parnassus Heights - Neurology","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University Medical Center - Neurology","city":"Stanford","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Cancer Center - Anschutz Medical Campus - University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at HCA HealthONE Presbyterian St. Luke's","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at Florida Cancer Specialists- Lake Nona","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital - Neurology","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute - Oncology Department","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"START | Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai - Oncology","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center New York - Main Campus","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Dallas - Oncology Department","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START | San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Froedtert Hospital - Clinical Cancer Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chris O'Brien Lifehouse","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Concord Repatriation General Hospital (CRGH) (Concord Hospital) - Concord Cancer Centre","city":"Concord","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern Hospital","city":"Epping","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Calvary Mater Hospital Newcastle - Oncology","city":"Waratah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antwerp University Hospital | Oncology Department","city":"Antwerp","state":"Antwerp","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ghent University Hospital | Drug Research Unit Department","city":"Ghent","state":"East Flanders","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven Gasthuisberg - Pneumology Department","city":"Leuven","state":"Flemish Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Liege - Domaine Universitaire du Sart Tilman - Medical Oncology","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer Hospital - Oncology Department","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing chest hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tongji Hosp. of Tongji Med Coll, Huazhong Uni of Sci & Tech.","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Provincial People's Hospital - The First Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fakultní nemocnice Olomouc - Onkologická klinika","city":"Olomouc","state":"Olomouc Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Masarykova Univerzita - Masarykuv Onkologicky Ustav (MOU) - Klinika Komplexni Onkologicke Pece (KKOP)","city":"Brno","state":"South Moravian","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet Copenhagen University Hospital | Oncology Department","city":"Copenhagen","state":"Capital Region / Region Hovedstaden","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Odense University Hospital | Svendborg Sygehus - Oncology Department","city":"Odense","state":"Region of Southern Denmark / Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro di Riferimento Oncologico di Aviano - Oncologia Medica e dei Tumori Immuno-Correlati","city":"Aviano","state":"Friuli Venezia Giulia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Fase I","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"I.F.O. Istituti Fisioterapici Ospitalieri - Sperimentazioni cliniche Fase 1 e Medicina di precisione","city":"Rome","state":"Lazio","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia","city":"Rozzano","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa","state":"Chiba","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kindai University Hospital","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Sunto","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Koto-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Medisch Centrum","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Groningen (UMCG) - UMC Groningen Comprehensive Cancer Center","city":"Groningen","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National University Hospital Medical Centre","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Singapore - Oncology Department","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icon Cancer Centre","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad De Navarra | Pamplona | Oncologia","city":"Pamplona","state":"Chartered Community Of Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital San Pedro | Oncologia","city":"Logroño","state":"La Rioja","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT - Hospital Universitario Quironsalud Madrid | Oncologia","city":"Pozuelo de Alarcón","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Hm Nou Delfos | Oncologia","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall D Hebron | Oncologia","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundacion Jimenez Diaz | Oncologia","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen De La Victoria | Oncologia","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario De Valencia | Oncologia","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Karolinska Universitetssjukhuset - Solna - Fas I-enheten Solna CKC","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sahlgrenska Universitetssjukhuset - Sahlgrenska Sjukhuset - Klinisk prövningsenhet Fas I/FIH","city":"Gothenburg","state":"Västra Götaland County","country":"Sweden","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital | Experimental Cancer Medicine Team","city":"Manchester","state":"Greater Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden (Surrey) | Oak Foundation Drug Development Unit","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bayer Clinical Trials Contact","phone":"18888422937","email":"clinical-trials-contact@bayer.com"}],"primaryOutcomes":["Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent adverse events (TEAEs)","Dose Escalation (Master and Intervention Cohort 1): Number of participants with treatment-emergent serious adverse events (TESAEs)","Dose Escalation (Master and Intervention Cohort 1): Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)","Dose Escalation (Master and Intervention Cohort 1): Incidence of dose-limiting toxicities (DLTs)","Dose Escalation (Master and Intervention Cohort 1): Number of participants with DLTs","Dose Escalation (Master and Intervention Cohort 1): Maximum concentration (Cmax) of the respective dosing interval of BAY 3713372","Dose Escalation (Master and Intervention Cohort 1): Area under the curve (AUC) of the respective dosing interval of BAY 3713372","Dose Expansion (Master, Intervention Cohorts 1 - 6): Objective response rate (ORR)","Dose Expansion (Intervention Cohorts 3, 4 and 6): Number of participants with DLTs","Intervention Cohort 7: Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)","Intervention Cohort 7: Severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)","Intervention Cohort 7: Number of participants with DLTs","Intervention Cohort 7: Brain and brain tumor PK concentration of BAY 3713372","Intervention Cohort 7: Tumor tissue SDMA levels"],"hasResults":false,"conditionSlugs":["lung-cancer","glioblastoma","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","duarte-california","los-angeles-california","san-francisco-california","stanford-california","aurora-colorado","denver-colorado","orlando-florida","boston-massachusetts","grand-rapids-michigan","new-york-new-york","nashville-tennessee","irving-texas","san-antonio-texas","milwaukee-wisconsin","camperdown-australia","concord-australia","epping-australia","waratah-australia","antwerp-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","beijing-china","wuhan-china","nanjing-china","hangzhou-china","olomouc-czechia","brno-czechia","copenhagen-denmark","odense-denmark","aviano-italy","rome-italy","milan-italy","rozzano-italy","nagoya-japan","kashiwa-japan","sakai-japan","sunto-japan","chuo-ku-japan","koto-ku-japan","amsterdam-netherlands","rotterdam-netherlands","groningen-netherlands","singapore-singapore","pamplona-spain","logro-o-spain","pozuelo-de-alarc-n-spain","barcelona-spain","madrid-spain","m-laga-spain","valencia-spain","stockholm-sweden","gothenburg-sweden","manchester-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing BAY 3713372 for MTAP-deleted Solid Tumors","inPlainEnglish":"The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5).","whoItsFor":["Ages 18 Years to any","At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1)","Homozygous MTAP-deletion identified through molecular testing from a locally certified laboratory","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"],"whoShouldSkip":["A marked prolongation of QT/QTc interval at screening (e.g., repeated demonstration of a QTc interval \\>450 ms). Participants with permanent pacemakers (i.e., a paced rhythm) may be eligible based on the investigator's clinical assessment and discretion","Cardiac history comprising:","History of congestive heart failure Class \\>II according to the New York Heart Association Functional Classification","Myocardial infarction less than 6 months before the start of study intervention","Serious cardiac arrhythmias requiring treatment or any clinically important abnormalities in rhythm, conduction or morphology on resting ECG with the exception of atrial fibrillation which is well-controlled and requires only digoxin or beta blockers","Unstable angina within 4 weeks before start of study intervention"],"whatHappens":"If you join, the listed intervention(s) are BAY 3713372. The registry lists allocation as randomized. The study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 450 people at 63 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.486Z"},{"nctId":"NCT06914427","title":"PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique","officialTitle":"PET/CT Imaging Study With Simultaneous Dual-nuclide Imaging Technique","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Xijing Hospital","sponsorClass":"OTHER","summary":"This is a study using a self-control approach and is expected to recruit 35 volunteers, including prostate cancer patients, neuroendocrine tumour patients, glioma patients, lung cancer patients, and normal volunteers, to undergo dual-tracer PET/CT imaging and to validate the separation performance and quantitative accuracy of simultaneous dual-tracer imaging in humans.","conditions":["Prostatic Neoplasms","Glioma","Lung Cancer","Neuroendocrine Tumors"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"PET/CT"}],"enrollment":35,"startDate":"2025-04-01","completionDate":"2027-03-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age: 18 \\~75 years old (including boundary values);\n* Gender: male or female;\n* Normal volunteers: males weighing ≥50kg, females weighing ≥45kg, and body mass index \\[BMI = weight (kg)/height 2 (m2)\\] within the range of 19.0 \\~ 26.0kg/m2 (including borderline values);\n* patients with prostate cancer: patients with pathologically-confirmed biochemical relapsed or primary diagnosed prostate cancer with highly suspected systemic metastases on conventional imaging or PSA levels;\n* patients with neuroendocrine tumour patients: patients with NET (G2-G3) or NEC confirmed by pathology and highly suspected of having more than 3 metastases by conventional imaging;\n* patients with glioma：patients with glioma confirmed by pathology or highly suspected by enhanced MRI and proposed to undergo surgical resection; patients with Lung cancer: patients with lung cancer or suspected recurrent lung cancer.\n* Subjects can fully understand and voluntarily participate in this experiment and sign an informed consent form.\n\nExclusion Criteria:\n\n* Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness);\n* those with alcohol allergy;\n* and those who, in the opinion of the investigator, are unsuitable to undergo or are unable to complete imaging studies such as PET for specific reasons;\n* Under 18 years of age or ECOG score \\> 2;\n* Less than 1 month after completion of radiotherapy and less than 2 months after completion of octreotide treatment in patients with neuroendocrine tumours;\n* Women during pregnancy and breastfeeding;\n* Practitioners requiring prolonged exposure to radioactive conditions;\n* Serious diseases of heart, kidney, lung, vascular, nervous and mental systems, immunodeficiency diseases and hepatitis/cirrhosis;\n* Participation in other interventional clinical trials within 1 month prior to screening;\n* Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.","locations":[{"facility":"Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Qiqi Yang Qiqi Yang","phone":"0086+18992601101","email":"yangqiqi_1101@163.com"}],"primaryOutcomes":["Signal retention","Clearance","SUVmax difference values"],"hasResults":false,"conditionSlugs":["prostate-cancer","lung-cancer"],"drugSlugs":[],"locationSlugs":["xian-china"],"enrichment":{"headline":"Not a traditional drug phase: PET/CT for Prostatic Neoplasms","inPlainEnglish":"This is a study using a self-control approach and is expected to recruit 35 volunteers, including prostate cancer patients, neuroendocrine tumour patients, glioma patients, lung cancer patients, and normal volunteers, to undergo dual-tracer PET/CT imaging and to validate the separation performance and quantitative accuracy of simultaneous dual-tracer imaging in humans.","whoItsFor":["Ages 18 Years to 75 Years","Age: 18 \\~75 years old (including boundary values);","Gender: male or female;","Normal volunteers: males weighing ≥50kg, females weighing ≥45kg, and body mass index \\[body-mass index (BMI) = weight (kg)/height 2 (m2)\\] within the range of 19.0 \\~ 26.0kg/m2 (including borderline values);","patients with prostate cancer: patients with pathologically-confirmed biochemical relapsed or primary diagnosed prostate cancer with highly suspected systemic metastases on conventional imaging or PSA levels;","patients with neuroendocrine tumour patients: patients with NET (G2-G3) or NEC confirmed by pathology and highly suspected of having more than 3 metastases by conventional imaging;","patients with glioma：patients with glioma confirmed by pathology or highly suspected by enhanced MRI and proposed to undergo surgical resection; patients with Lung cancer: patients with lung cancer or suspected recurrent lung cancer"],"whoShouldSkip":["Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness);","those with alcohol allergy;","and those who, in the opinion of the investigator, are unsuitable to undergo or are unable to complete imaging studies such as PET for specific reasons;","Under 18 years of age or ECOG score \\> 2;","Less than 1 month after completion of radiotherapy and less than 2 months after completion of octreotide treatment in patients with neuroendocrine tumours;","Women during pregnancy and breastfeeding;","Practitioners requiring prolonged exposure to radioactive conditions;"],"whatHappens":"If you join, the listed intervention(s) are PET/CT. The registry lists allocation as na. This is a study using a self-control approach and is expected to recruit 35 volunteers, including prostate cancer patients, neuroendocrine tumour patients, glioma patients, lung cancer patients, and normal volunteers, to undergo dual-tracer PET/CT imaging and to validate the separation performance and quantitative accuracy of simultaneous dual-tracer imaging in humans.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 35 people at Xi'an. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.307Z"},{"nctId":"NCT06915363","title":"BioPoly® Partial Resurfacing Knee Implant IDE","officialTitle":"Pivotal, Prospective, Randomized, Controlled, Multicenter Clinical Trial of BioPoly® Partial Resurfacing Knee Implant for Treatment of Focal Cartilage Lesions of the Distal Femur","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BioPoly LLC","sponsorClass":"INDUSTRY","summary":"The goal of this randomized controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group.\n\nThe primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by:\n\n* no secondary surgical intervention (SSI) and\n* an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points.\n\nResearchers will compare the CCS for the investigational device group to a control group receiving the standard of care, either microfracture or debridement).\n\nSubjects randomized to the investigational group will receive the BioPoly Knee device and those randomized to the control group will receive the current standard of care, either microfracture or debridement.","conditions":["Knee Pain Chronic","Knee Osteoarthritis","Cartilage Damage","Cartilage Defects of the Knee","Cartilage or Osteochondral Defects in the Knee","Cartilage Lesion"],"keywords":["articular cartilage","cartilage lesion","focal cartilage defect","cartilage defect"],"interventions":[{"type":"DEVICE","name":"BioPoly"},{"type":"PROCEDURE","name":"surgical standard of care (SSOC)"}],"enrollment":152,"startDate":"2025-03-17","completionDate":"2028-12","sex":"ALL","minAge":"30 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patient is between 30 and 65 years of age25.\n2. KOOS quality of life score ≤ 60.\n3. In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol.\n4. Patient has cartilage lesion that has failed non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) after at least 2 months of beginning the therapy or failed surgical conservative therapy (e.g. debridement/lavage, marrow stimulation, or alignment high tibial osteotomy) that was performed at least 12 months ago in the index knee and is a candidate for surgical intervention.\n5. Patient has cartilage lesion located in the femoral condyle or trochlear facet.\n6. Patient has lesion(s) classified as ICRS grade 2, 3 or 4.\n7. Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an overall depth less than 4mm from the articulating surface.\n8. Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl.\n\nExclusion Criteria:\n\n1. Patient has body mass index (BMI) ≥ 35.\n2. Patient has autoimmune arthritis, as diagnosed by Investigator.\n3. Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively).\n4. Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery.\n5. Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months.\n6. Patient has a cartilage lesion that is being treated with a non-surgical conservative therapy (e,g, anti-inflammatory (NSAID), viscosupplementation, steroid injection, physical therapy, or activity modification) and it has been \\< 2 months since beginning treatment or the patient's cartilage lesion has failed surgical therapy (e.g. debridement/lavage, marrow stimulation, alignment (high tibial osteotomy)) in the index knee and it has been \\< 12 months since the surgical treatment.\n7. Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment.\n8. Patient has malalignment of the index knee (\\>5 degrees weight bearing varus or valgus).\n9. Patient has bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e. greater than ICRS Grade 2 on the opposing articular surface) in the index knee.\n10. Patient has uncorrected ligamentous instability (good joint stability in the index joint with a Grade 1 Lachman or less, no pivot shift for ACL insufficiency and no posterior translation of more than grade 1; no deficits in flexion or extension of \\> 10 degrees compared to contralateral knee) in the index knee.\n11. Patient has undergone a total meniscectomy of index knee.\n12. Patient has undergone patellofemoral arthroplasty of the index knee\n13. Patient currently reports or has a documented history of uncontrolled diabetes.\n14. Patient currently has any condition, therapy, or medication known to impair bone healing.\n15. Patient has had an active systemic infection or joint infection in index knee over the last 12 months.\n16. Patient has an allergy to titanium alloy (Ti-6Al-4V), ultrahigh molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA).\n17. Patient is pregnant or is planning to become pregnant (for female patients only) at any point during the duration of the study.\n18. Patient has legal involvement or any other issue that would hinder completion of the two-year follow-up period.\n19. Patient is participating in other studies and/or receiving any other simultaneous therapy in index knee.\n20. Patient has an uncorrected tear of the meniscus of the index knee. (Partial meniscectomy that retains \\>50% of the meniscus is allowed prior to or concurrently with the cartilage treatment procedure. Meniscus suture repair is allowed prior to or concurrently with the cartilage treatment procedure if \\>50% of the functional meniscus remains.).\n21. Patient has an additional cartilage lesion(s) (ICRS Grade 3 or 4) in the index knee, located on the patella, trochlea, tibia, or non-weight bearing area of index condyle that requires treatment.\n22. More than one implant is required to accommodate defect in the index knee.\n23. Patient has inadequate bone stock (e.g., cysts, osteoporosis) underlying the lesion site as determined intra-operatively by the investigator\n\n    1. As determined by the investigator through use of an awl or a similar instrument to determine if the bone quality is insufficient to support the BioPoly device.\n    2. If the cause of inadequate bone stock is due to cysts or to the boney portion of an osteochondral lesion being excessive, then the investigator may opt to fix the implant with cement rather than exclude the patient for inadequate bone stock.\n24. Patients with osteoporosis, osteopenia, Paget's disease, osteomalacia or any other metabolic bone disease; a. Osteoporosis is defined as Simple Calculated Osteoporosis Risk Estimation (SCORE) above 6 and DXA T-score \\< -2.5 or QCT T-score \\< 80mg/cubic cm. History of a fragility fracture requires that a DXA scan or QCT scan is completed","locations":[{"facility":"Stanford Medicine Dept of Orthopaedic Surgery","city":"Redwood City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dupont Hospital","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OrthoIndy","city":"Indianapolis","state":"Indiana","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University Orthopedics","city":"Chesterfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sheila Schwartz, R.Ph.","phone":"2609996135","email":"sheila@biopolyortho.com"}],"primaryOutcomes":["Improvement in the Knee injury and Osteoarthritis Outcome Score (KOOS) to Assess Composite Clinical Success (CCS) effectiveness","Composite Clinical Success (CCS) Safety as Measured by No Secondary Surgical Intenvention"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["redwood-city-california","fort-wayne-indiana","indianapolis-indiana","rochester-minnesota","chesterfield-missouri"],"enrichment":{"headline":"Not a traditional drug phase: BioPoly for Knee Pain Chronic","inPlainEnglish":"The goal of this randomly assigned controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group. The primary effectiveness endpoint is Month 24 composite clinical success (CCS) defined by: * no secondary surgical intervention (SSI) and * an improvement from baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS) total score (scaled 0 to 100) of at least 10 points.","whoItsFor":["Ages 30 Years to 65 Years","Patient is between 30 and 65 years of age25","KOOS quality of life score ≤ 60","In the opinion of the Investigator, the patient has the understanding and willingness to comply with all study requirements including the Post-Operative rehabilitation and follow-up protocol","Patient has cartilage lesion located in the femoral condyle or trochlear facet","Patient has lesion(s) classified as ICRS grade 2, 3 or 4","Patient's lesion size may not exceed 3.1 cm2 and must be circumscribed by a 1.5 cm or 2.0 cm diameter circle, or 1.5 cm (M-L) by 2.4 cm (A-P) oval of normal or nearly normal (ICRS grade 0 or 1) cartilage, with an overall depth less than 4mm from the articulating surface","Patient has subchondral bone quality that is non-osteoporotic and is sufficient to support the implant. The quality of bone will be assessed by the surgeon intraoperatively with a surgical instrument such as an awl"],"whoShouldSkip":["Patient has body mass index (body-mass index (BMI)) ≥ 35","Patient has autoimmune arthritis, as diagnosed by Investigator","Patient has advanced degenerative osteoarthritis in index knee (Kellgren-Lawrence Grade 4 and/or diagnosed intraoperatively)","Contralateral knee is known to have symptomatic cartilage, meniscal, or ligamentous lesions, generalized osteoarthritis, or requires surgery","Patient has gout, by Investigator diagnosis or patient-reported history within last 12 months","Patient has a cartilage lesion that is being treated that has failed ACI, OATS or Allograft treatment","Patient has malalignment of the index knee (\\>5 degrees weight bearing varus or valgus)"],"whatHappens":"If you join, the listed intervention(s) are BioPoly, or surgical standard of care (SSOC). The registry lists allocation as randomized. The goal of this randomly assigned controlled clinical trial is to demonstrate the safety and effectiveness of the BioPoly® Partial Resurfacing Knee Implant for the treatment of cartilage defects of the distal femur in adult patients with knee pain and symptoms who are candidates for surgical intervention of the knee compared to outcomes for the control group.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 152 people at 5 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.509Z"},{"nctId":"NCT06919965","title":"A Study to Evaluate TAR-210 Versus Intravesical Chemotherapy Treatment in Participants With High Risk Non-Muscle-Invasive Bladder Cancer","officialTitle":"A Phase 3, Randomized, Open-label, Multicenter Study Evaluating the Efficacy and Safety of TAR-210 Erdafitinib Intravesical Delivery System Versus Investigator's Choice of Intravesical Chemotherapy in Participants With High-risk Non-muscle-invasive Bladder Cancer With Susceptible FGFR Alterations Who Had Received Intravesical Bacillus Calmette-Guérin (BCG)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).","conditions":["Non-Muscle Invasive Bladder Neoplasms"],"keywords":[],"interventions":[{"type":"DRUG","name":"TAR-210"},{"type":"DRUG","name":"Mitomycin C"},{"type":"DRUG","name":"Gemcitabine"}],"enrollment":220,"startDate":"2025-09-10","completionDate":"2028-04-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded\n* Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing\n* All visible tumor completely resected prior to randomization. Urine cytology must not be positive or suspicious for high grade UC before randomization. For participants with lamina propria invasion (T1) on the screening biopsy/TURBT, muscularis propria must be present to rule out MIBC\n* Participants must have had either: a. Adequate Induction (5 of 6 doses) and either 2 of 3 doses of Maintenance or 2 of 6 doses of second Induction of BCG with high-grade T1 disease at first disease assessment after induction or high-grade Ta/any T1 disease within 6 months after last BCG (BCG-unresponsive population); b. had adequate induction (5 or 6 doses) with or without maintenance BCG with high-grade Ta/any T1 disease within 12 months after last BCG excluding BCG-unresponsive (BCG-experienced population); or c. been unable to complete an induction course of BCG with at least 5 doses due to grade \\>= 2 toxicity requiring BCG discontinuation (BCG intolerant population)\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2\n* Must be ineligible for or refusing radical cystectomy (RC)\n\nExclusion criteria:\n\n* Presence of CIS at any point from time of diagnosis of papillary-only HR-NMIBC recurrence to randomization. Additionally, presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is \\[i.e.\\], T2, T3, T4, N+, and/or M+)\n* Active malignancies (i.e., progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Allowed recent second or prior malignancies: a. Any malignancy that was not progressing nor requiring treatment change in the last 12 months; b. Malignancies treated within the last 12 months and considered at very low risk for recurrence for example (e.g.): non-melanoma skin cancers (treated with curative therapy or localized melanoma treated with curative surgical resection alone), non-invasive cervical cancer, breast cancer (adequately treated lobular CIS or ductal CIS, localized breast cancer and receiving antihormonal agents), localized prostate cancer (\\[N0, M0\\] with a Gleason score less than or equal to \\[\\<=\\] 7a, treated locally only \\[radical prostatectomy/radiation therapy/focal treatment\\]) and other malignancy that is considered at minimal risk of recurrence\n* Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210\n* A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\\>) 4,000 milliliters (mL)\n* Indwelling catheters are not permitted; however, intermittent catheterization is acceptable","locations":[{"facility":"Academic Urology and Urogynecology of Arizona","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Clinical Research","city":"Lakewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Urology Institute","city":"Largo","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georgia Urology","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associated Urological Specialists","city":"Chicago Ridge","state":"Illinois","country":"United 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Univ. 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Virgen de La Victoria","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp.Univ.Parc Tauli","city":"Sabadell","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hull University Teaching Hospitals NHS Trust","city":"Cottingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomews Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"Skerray","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southampton University Hospital","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lister Hospital","city":"Stevenage","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Disease-free Survival (DFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["sun-city-arizona","los-angeles-california","lakewood-colorado","largo-florida","atlanta-georgia","chicago-ridge-illinois","glenview-illinois","carmel-indiana","lafayette-louisiana","plymouth-massachusetts","royal-oak-michigan","omaha-nebraska","voorhees-township-new-jersey","syracuse-new-york","centerville-ohio","cincinnati-ohio","gahanna-ohio","middleburg-heights-ohio","springfield-oregon","bala-cynwyd-pennsylvania","lancaster-pennsylvania","pittsburgh-pennsylvania","myrtle-beach-south-carolina","germantown-tennessee","austin-texas","san-antonio-texas","chabas-argentina","ciudad-evita-argentina","c-rdoba-argentina","rosario-argentina","san-mart-n-de-los-andes-argentina","brussel-bruxelles-belgium","genk-belgium","gent-ghent-belgium","leuven-belgium","roeselare-belgium","natal-brazil","presidente-prudente-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","beijing-china","chengdu-china","guangzhou-china","nanjing-china","ningbo-china","tianjin-china","wenzhou-china","wuhan-china","yantai-china","marseille-france","paris-france","quint-fonsegrives-france","saint-gr-goire-france","villejuif-france","cologne-germany","herne-germany","leverkusen-germany","mannheim-germany","n-rtingen-germany","regensburg-germany","athens-greece","thessaloniki-greece","haifa-israel","kfar-saba-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","bergamo-italy","brescia-italy","genova-italy","milan-italy","naples-italy","romagnano-italy","san-martino-di-lupari-italy","udine-italy","bunky-city-japan","funabashi-japan","hakodate-japan","kawasaki-japan","minatoku-japan","sakura-japan","yokohama-japan","nijmegen-netherlands","rotterdam-netherlands","utrecht-netherlands","cheongju-si-south-korea","ganggu-south-korea","seongnam-south-korea","seoul-south-korea","barcelona-spain","cadiz-spain","castill-n-spain","ferrol-spain","jerez-de-la-frontera-spain","la-coru-a-a-coru-a-spain","madrid-spain","m-laga-spain","sabadell-spain","cottingham-united-kingdom","london-united-kingdom","skerray-united-kingdom","southampton-united-kingdom","stevenage-united-kingdom"],"enrichment":{"headline":"Phase 3: testing TAR-210 for Non-Muscle Invasive Bladder Neoplasms","inPlainEnglish":"The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).","whoItsFor":["Ages 18 Years to any","Histologically confirmed diagnosis by local pathology of papillary-only HR-NMIBC (defined as high-grade Ta or any T1, no CIS). Mixed histology tumors are allowed if urothelial differentiation is predominant. However, neuroendocrine, and small cell variants will be excluded","Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue) as determined by central or local testing","Have an Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0, 1, or 2","Must be ineligible for or refusing radical cystectomy (RC)"],"whoShouldSkip":["Presence of any bladder or urethral anatomic feature that, in the opinion of the investigator, may prevent the safe placement, indwelling use, or removal of TAR 210","A history of clinically significant polyuria with recorded 24 hour urine volumes greater than (\\>) 4,000 milliliters (mL)","Indwelling catheters are not permitted; however, intermittent catheterization is acceptable"],"whatHappens":"If you join, the listed intervention(s) are TAR-210, Mitomycin C, or Gemcitabine. The registry lists allocation as randomized. The main purpose of this study is to compare the disease-free survival (the length of time after randomization that a participant survives without any signs or symptoms of the cancer returning, or progressing) between Bacillus Calmette-Guérin (BCG) treated participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of high-risk non-muscle-invasive bladder cancer (HR-NMIBC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 220 people at 115 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.316Z"},{"nctId":"NCT06920043","title":"A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH","officialTitle":"A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.","conditions":["Metabolic Dysfunction-Associated Steatohepatitis","Non-alcoholic Fatty Liver Disease"],"keywords":["Fibroblast growth factor","Stage 4 fibrosis","Compensated Cirrhosis"],"interventions":[{"type":"DRUG","name":"Efimosfermin"},{"type":"DRUG","name":"Placebo"}],"enrollment":42,"startDate":"2025-04-09","completionDate":"2028-07-03","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to understand and sign a written informed consent form (ICF)\n* Age 18 through 75 years at enrollment\n* History or presence of 2 or more of the 5 components of metabolic syndrome\n* Liver biopsy confirmation of MASH consistent with stage F4 fibrosis\n* Other inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease\n* History of type 1 diabetes\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)\n* Other exclusion criteria may apply.","locations":[{"facility":"GSK Investigational Site","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Mesa","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Santa Maria","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Viera","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fayetteville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Wilson","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Pasadena","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Pearland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Waco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Number of participants with treatment emergent adverse events (TEAEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["chandler-arizona","mesa-arizona","tucson-arizona","fresno-california","lancaster-california","pasadena-california","rialto-california","santa-maria-california","miami-florida","viera-florida","marietta-georgia","baltimore-maryland","kansas-city-missouri","new-york-new-york","fayetteville-north-carolina","wilson-north-carolina","austin-texas","dallas-texas","georgetown-texas","houston-texas","pasadena-texas","pearland-texas","san-antonio-texas","waco-texas","richmond-virginia"],"enrichment":{"headline":"Phase 2: testing Efimosfermin for Metabolic Dysfunction-Associated Steatohepatitis","inPlainEnglish":"This study wants to measure the safety, tolerability, preliminary how well it works, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.","whoItsFor":["Ages 18 Years to 75 Years","Age 18 through 75 years at enrollment","History or presence of 2 or more of the 5 components of metabolic syndrome","Liver biopsy confirmation of MASH consistent with stage F4 fibrosis","Other who can join may apply"],"whoShouldSkip":["Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease","History of type 1 diabetes","Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)"],"whatHappens":"If you join, the listed intervention(s) are Efimosfermin, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, preliminary how well it works, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 42 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.147Z"},{"nctId":"NCT06920628","title":"PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)","officialTitle":"PET Imaging of Cyclooxygenase-1 in Participants With Neurological Manifestations of Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nSARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain. These include headaches; loss of taste and smell; sleep problems; thinking problems; depression; and anxiety. Researchers want to know if a tracer (a substance that is injected into a person s body before an imaging scan) can help identify inflammation in people with these brain disorders.\n\nObjective:\n\nTo see if a radioactive tracer (\\[11C\\]PS13) can highlight brain inflammation in those who had COVID-19 but still have symptoms that affect the brain.\n\nEligibility:\n\nAdults aged 18 to 70 years with post COVID-19 brain disorders who are enrolled in protocol 000089 or 000711. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits.\n\nParticipants will be screened. They will have blood tests and a test of their heart function.\n\nThey will have imaging scans:\n\nMagnetic resonance imaging (MRI): They will lie on a table that slides into a metal tube. Pictures will be taken of the brain.\n\nPositron emission tomography (PET): A needle attached to a thin tube will be inserted into a vein in the arm. The tracer will be injected through the tube. Another needle attached to a thin tube will be inserted into the wrist or inside of the elbow of the other arm to draw blood. They will lie still on a bed while a machine captures images of their brain. The scan will last about 2 hours.\n\nStudy involvement is 11 to 14 weeks....","conditions":["Long COVID","Post Acute Sequelae of COVID-19"],"keywords":["Inflammation","COVID","SARS","Neuro-PASC"],"interventions":[{"type":"DRUG","name":"11C-PS13"}],"enrollment":60,"startDate":"2025-06-18","completionDate":"2028-02-22","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nPatients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria:\n\n* Aged 18 to 70 years of age.\n* Participants must be in good general health as evidenced by medical history and physical examination.\n* Each participant must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.\n* Participants must have undergone a screening assessment under protocol #000089, Natural History of Post-Coronavirus Disease 19 Convalescence at the National Institutes of Health or #000711 Immunotherapy for Neurological Post-Acute Sequelae of SARSCoV-2 (INPASC) and determined to have neuro-PASC.\n* Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Participants must agree to adhere to the lifestyle considerations.\n\nHealthy Volunteers: To be eligible to participate in this study, healthy volunteers must meet all of the following criteria:\n\n* Aged 18 to 70 years of age.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Does not have an active SARS-CoV-2 infection. The protocol will conform with NIH CC standards for documenting a participant does not have active SARS-CoV-2 infection. This may include screening interviews and/or testing.\n* Participants must be at least six weeks out since the onset of SARS-CoV-2 symptoms with no fever for at least one week.\n* Participants must report having at least one prior SARS-CoV-2 infection.\n* Be enrolled in 01M0254, The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers or 17M0181, Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies .\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nParticipants with Neuro-PASC who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing based on individual clinical judgement. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen). Any lab value that is two times the upper limit or lower values, as per the investigator s judgment. Creatinine level \\>1.3 mg/dL.\n* Participants should not have taken Non-Steroidal Anti-Inflammatory Drug (NSAID)s for two weeks prior to each PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g. methotrexate) must not have been taken within one month prior to each PET scan.\n* Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.\n* Participants who have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits as determined by the study team.\n* Have an inability to lie flat and/or lie still on the camera bed for at least two hours,including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Pregnancy or Breastfeeding Women.\n* HIV Infection.\n\nHealthy volunteers who meet any of the following criteria will be excluded from participation in this study:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants should not have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for two weeks prior to the PET scan. Corticosteroids (with the exception of topical steroids), or immunosuppressants (e.g., methotrexate) must not have been taken within one month prior to the PET scan.\n* Participants with an active SARS-CoV-2 infection.\n* Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not exclusion criteria, unless that use impairs daily life functions.\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the participant during the screening visit.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye.\n* Pregnancy or Breastfeeding Women.\n* HIV Infection.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tara N Turon, C.R.N.P.","phone":"(301) 827-6599","email":"tara.turon@nih.gov"},{"name":"Robert B Innis, M.D.","phone":"(301) 594-1368","email":"robert.innis@nih.gov"}],"primaryOutcomes":["To measure distribution volume for 11C-PS13"],"hasResults":false,"conditionSlugs":["als","depression","long-covid"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing 11C-PS13 for Long COVID","inPlainEnglish":"Background: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have long-term symptoms that affect the brain.","whoItsFor":["Ages 18 Years to 70 Years","Patients: To be eligible for this study, Neuro-PASC participants must meet all of the following criteria:","Aged 18 to 70 years of age","Participants must be in good general health as evidenced by medical history and physical examination","Participants must have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists","Participants must agree to adhere to the lifestyle considerations","Healthy Volunteers: To be eligible to participate in this study, healthy volunteers must meet all of the following criteria:","Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment"],"whoShouldSkip":["Participants with Neuro-PASC who meet any of the following criteria will be excluded from participation in this study:","Participants must not have substance use disorder or alcohol use disorder. However, alcohol or cannabis use by themselves are not"],"whatHappens":"If you join, the listed intervention(s) are 11C-PS13. The registry lists allocation as na. Background: SARS-CoV-2 is the virus that causes COVID-19.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.244Z"},{"nctId":"NCT06922318","title":"The COSMYC Trial (COmbined Suppression of MYC)","officialTitle":"A Phase II Study of Sequential Bipolar Androgen Therapy and ZEN-3694 in Sequence With Enzalutamide + ZEN-3694 in Asymptomatic Patients With Metastatic CRPC: The COSMYC Trial (COmbined Suppression of MYC)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsorClass":"OTHER","summary":"This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.","conditions":["Metastatic Castration-resistant Prostate Cancer"],"keywords":["Prostate Cancer","ZEN-3694","Bipolar androgen therapy","testosterone cypionate","enzalutamide"],"interventions":[{"type":"DRUG","name":"ZEN-3694"},{"type":"DRUG","name":"Testosterone cypionate"},{"type":"DRUG","name":"Enzalutamide"},{"type":"DRUG","name":"Luteinizing hormone-releasing hormone (LHRH) analogue"}],"enrollment":50,"startDate":"2025-08-19","completionDate":"2031-08-30","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) Performance status ≤2.\n2. Age ≥18 years.\n3. Histologically-confirmed adenocarcinoma of the prostate.\n4. Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist).\n5. Documented castrate level of serum testosterone (\\<50 ng/dl).\n6. Metastatic disease radiographically documented by CT or bone scan. While CT scan is preferred, Prostate-Specific Membrane Antigen (PSMA) scan (e.g. Pylarify) may be substitute for CT scan if evidence of metastatic disease observed on the CT portion of the PSMA scan.\n7. Must have had disease progression while on a second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) based on:\n\n   PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart i. And/ Or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease\n8. Screening PSA must be ≥ 1.0 ng/mL.\n9. Patients with soft tissue lesion amenable to biopsy must agree to biopsy collection pre-treatment and at a defined point on treatment to perform tumor tissue analysis.\n10. Prior treatment with Provenge vaccine, 223 Radium (Xofigo), poly(ADP-ribose) polymerase (PARP) inhibitors, taxane chemotherapy, Pluvicto, antiandrogens (including enzalutamide, darolutamide, and apalutamide), and radiation is allowed if \\>4 weeks from last dose.\n11. Prior treatment with BAT is allowed if the patient has progressed on an AR-axis inhibitor (i.e. abiraterone or antiandrogen) since BAT treatment.\n12. Patients must be withdrawn from second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) for ≥ 2 weeks.\n13. Attempts must be made to wean patients off prednisone prior to starting therapy. Patients who cannot be weaned due to symptoms may continue on lowest dose of prednisone achieved during weaning period.\n14. Acceptable liver function:\n\n    1. Bilirubin \\< 2.5 times institutional upper limit of normal (ULN)\n    2. Aspartate Transferase (AST) (SGOT) and Alanine Transaminase (ALT) (SGPT) \\< 2.5 times ULN\n15. Acceptable renal function:\n\n    a. Serum creatinine \\<2.5 times ULN\n16. Acceptable hematologic status:\n\n    1. Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 (1.5 ×109/L)\n    2. Platelet count ≥ 100,000 platelet/mm3 (100 ×109/L)\n    3. Hemoglobin ≥ 7.5 g/dL.\n17. Ability to understand and willingness to sign a written informed consent document.\n18. Sexually active participants with female partners of childbearing potential are eligible to participate if they agree to follow 1 of the following methods of contraception consistently, starting from screening, during the study and for at least 3 months after the last dose of ZEN-3694 and/or enzalutamide:\n\n    i. Are abstinent from penile-vaginal intercourse as their usual and preferred lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.\n\n    ii. Are sterilized (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate); iii. Agree to use a male condom and have their partner use a contraceptive method with a failure rate of \\<1% per year as described below when having penile-vaginal intercourse with a woman of childbearing potential who is not currently pregnant, and who agrees to the use of a condom by her partner.\n\n    b. In addition, participants must refrain from donating sperm starting from Screening, during the study and for at least 3 months after the last dose of ZEN-3694 and/or enzalutamide.\n19. Sexually active participants with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse; or use a male condom during each episode of penile penetration during the study\n20. Patients with soft-tissue disease amenable to biopsy as determined by Interventional Radiology must agree to serial biopsies as per the study schedule to be eligible.\n\nExclusion Criteria:\n\n1. Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication.\n2. ECOG Performance status ≥3\n3. Requirement for urinary self-catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH). Patients with indwelling Foley or suprapubic catheter for obstructive symptoms are eligible.\n4. Active uncontrolled infection. Patients with a history of HIV/AIDS may be eligible if cluster of differentiation 4 (CD4)+ T cell counts are ≥ 350 cell/ul, they have had no opportunistic infection within the past 12 months, they have been on established antiretroviral therapy (ART) for at least four weeks, the HIV viral load is less than 400 copies/ml prior to enrollment, and there is no significant drug-drug interaction with ART and the study drugs. Patients with chronic hepatitis B virus (HBV) infection with active disease who meet criteria for anti HBV therapy are eligible if they are on a suppressive antiviral therapy prior to enrollment and there is no drug-drug interaction with the study drugs. Patients with a history of HCV infection are eligible if they have completed curative antiviral treatment and the hepatitis C virus (HCV) viral load is below the limit of quantification.\n5. Any condition or mental impairment that may compromise the ability to give informed consent, patient's safety or compliance with study requirements as determined by the investigator.\n6. Patients receiving anticoagulation therapy with warfarin, rivaroxaban, or apixaban are not eligible for study. \\[Patients on enoxaparin or edoxaban are eligible for study. Patients on warfarin, rivaroxaban, or apixaban, who can be transitioned to one of these alternative agents prior to starting study treatments will be eligible\\].\n7. Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation.\n8. Hematocrit \\>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \\[per Endocrine Society Clinical Practice Guidelines (34)\\]\n9. Patients allergic to sesame seed oil or cottonseed oil are excluded.\n10. Major surgery (i.e. as defined by treating physician) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate.\n\nPatients with history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma, brain arteriovenous malformation).","locations":[{"facility":"Johns Hopkins Sidney Kimmel Comprehensive Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Samuel Denmeade, MD","phone":"410-733-3232","email":"denmesa@jhmi.edu"},{"name":"Sin Chan, MS","phone":"410-614-3630","email":"schan44@jhmi.edu"}],"primaryOutcomes":["Clinical/radiographic progression free survival (PFS) with BATZEN","Prostate specific antigen (PSA)-Progression free survival (PFS) with ZENZA"],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 2: testing ZEN-3694 for Metastatic Castration-resistant Prostate Cancer","inPlainEnglish":"This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies. The investigators also want to determine if dosing first with the combination of testosterone and ZEN-3694 may cause enzalutamide and ZEN-3694 to work more effectively.","whoItsFor":["Ages 18 Years to any","Men only","Eastern Cooperative Oncology Group (ECOG) Performance status ≤2","Histologically-confirmed adenocarcinoma of the prostate","Treated with continuous androgen ablative therapy (either surgical castration or LHRH agonist/antagonist)","Documented castrate level of serum testosterone (\\<50 ng/dl)","Metastatic disease radiographically documented by CT or bone scan. While CT scan is preferred, Prostate-Specific Membrane Antigen (PSMA) scan (e.g. Pylarify) may be substitute for CT scan if evidence of metastatic disease observed on the CT portion of the PSMA scan","Must have had disease progression while on a second-generation AR-axis inhibitor (Abiraterone, Enzalutamide, Darolutamide, or Apalutamide) based on:","PSA progression defined as an increase in PSA, as determined by 2 separate measurements taken at least 1 week apart i. And/ Or Radiographic disease progression, based on RECIST 1.1 in patients with measurable soft tissue lesions or PCWG3 for patients with bone disease"],"whoShouldSkip":["Pain due to metastatic prostate cancer requiring treatment intervention with opioid pain medication","how well you can do daily activities (ECOG score) ≥3","Patients are excluded with prior history of a thromboembolic event within the last 12 months that are not being treated with systemic anticoagulation","Hematocrit \\>51%, untreated severe obstructive sleep apnea, uncontrolled or poorly controlled heart failure \\[per Endocrine Society Clinical Practice Guidelines (34)\\]","Patients allergic to sesame seed oil or cottonseed oil are excluded","Major surgery (i.e. as defined by treating physician) within 3 weeks before screening, or has not fully recovered from prior surgery (i.e., unhealed wound). Note: subjects with planned surgical procedures to be conducted under local anesthesia may participate","Patients with history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma, brain arteriovenous malformation)"],"whatHappens":"If you join, the listed intervention(s) are ZEN-3694, Testosterone cypionate, or Enzalutamide. The registry lists allocation as randomized. This research is being done to determine if receiving the combination of testosterone and ZEN-3694 followed by the combination of enzalutamide plus ZEN-3694 will decrease the size of tumors in patients with prostate cancer that has become resistant to castration and other therapies.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.733Z"},{"nctId":"NCT06923800","title":"Exercise Interventions and Dietary Advice in Fibromyalgia and IBS","officialTitle":"Comparison of Two Exercise Interventions and Dietary Advice in Patients With Fibromyalgia and Irritable Bowel Syndrome: A Randomized Controlled Crossover Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis","sponsorClass":"OTHER","summary":"Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness. Central sensitization plays a key role, making the nervous system more responsive to pain. Though muscles are mainly affected, joint pain, stiffness, and reduced mobility are also common. Chronic pain and poor posture can worsen musculoskeletal health. FM is not mainly inflammatory, but pain and stress may affect bone health. Sleep disorders, like non-restorative sleep and apnea, are frequent and worsen fatigue. Neurotransmitter imbalances (e.g., serotonin, dopamine) affect pain and muscle function.\n\nThe American College of Rheumatology defines FM by widespread bilateral pain lasting at least three months. FM mainly affects women, with a prevalence of 0.2-6.6%, often starting between the ages of 30 and 35. Besides physical symptoms, many patients suffer from anxiety, depression, and mood disorders, affecting their quality of life.\n\nGastrointestinal issues, especially irritable bowel syndrome (IBS), are also frequent in FM patients. Both conditions share mechanisms such as pain hypersensitivity, altered autonomic regulation, gut-brain axis disruption, and immune dysfunction. Low-grade inflammation and intestinal permeability may contribute to chronic symptoms.\n\nFM treatment includes anticonvulsants, antidepressants, and painkillers. IBS is managed with diet changes and medications like antispasmodics. Due to limited drug effectiveness, multidisciplinary approaches are gaining attention. Physical exercise is a proven non-drug strategy that improves pain, fatigue, and mental health in FM and IBS. Still, adherence is low due to fear of pain, fatigue, and low motivation.\n\nExercise, especially aerobic activity, benefits IBS patients by improving gut symptoms and reducing inflammation. It may also strengthen the gut barrier in both conditions. While optimal programs need more study, exercise is a promising therapy. Major health bodies recommend aerobic, resistance, and flexibility training for FM and aerobic exercise for IBS.","conditions":["Fibromyalgia","Irritable Bowel Syndrome"],"keywords":["exercise","aerobic exercise","fibromyalgia","irritable bowel syndrome"],"interventions":[{"type":"BEHAVIORAL","name":"Combined Exercise Program + A specific nutritional plan for individuals with IBS"},{"type":"BEHAVIORAL","name":"Aerobic Exercise + A specific nutritional plan for individuals with IBS"}],"enrollment":30,"startDate":"2025-04-14","completionDate":"2028-09","sex":"FEMALE","minAge":"30 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS.\n* Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) \\> 175 (indicating moderate to severe IBS symptoms).\n* Men and women aged between 30 and 65 years.\n* Body Mass Index (BMI) between 18.5 and 34.9\n\nExclusion Criteria:\n\n* Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases.\n* Individuals unable to discontinue symptom management therapies and medications for FM/IBS.","locations":[{"facility":"IRCCS Saverio de Bellis","city":"Castellana Grotte","state":"Bari","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Antonella Bianco","phone":"+390804994653","email":"antonella.bianco@irccsdebellis.it"}],"primaryOutcomes":["Fibromyalgia symptom assesment","IBS symptoms assessment"],"hasResults":false,"conditionSlugs":["als","depression","ibs"],"drugSlugs":[],"locationSlugs":["castellana-grotte-italy"],"enrichment":{"headline":"Not a traditional drug phase: Combined Exercise Program + A specific nutritional plan for individuals with IBS for Fibromyalgia","inPlainEnglish":"Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties. Patients often experience hyperalgesia, allodynia, and muscle weakness.","whoItsFor":["Ages 30 Years to 65 Years","Women only","Confirmed diagnosis of Irritable Bowel Syndrome (IBS) concomitant with Fibromyalgia (FM).Meeting the American College of Rheumatology (ACR) diagnostic criteria for FM and meeting the Rome III/IV diagnostic criteria for IBS","Total score on the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) \\> 175 (indicating moderate to severe IBS symptoms)","Men and women aged between 30 and 65 years","Body Mass Index (body-mass index (BMI)) between 18.5 and 34.9"],"whoShouldSkip":["Individuals with severe cardiac, hepatic, neurological, psychiatric disorders, or other gastrointestinal diseases","Individuals unable to discontinue symptom management therapies and medications for FM/IBS"],"whatHappens":"If you join, the listed intervention(s) are Combined Exercise Program + A specific nutritional plan for individuals with IBS, or Aerobic Exercise + A specific nutritional plan for individuals with IBS. The registry lists allocation as randomized. Fibromyalgia (FM) is a chronic disorder marked by widespread musculoskeletal pain, fatigue, sleep disturbances, and cognitive difficulties.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Castellana Grotte. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.427Z"},{"nctId":"NCT06924021","title":"Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)","officialTitle":"Age-Related Macular Degeneration Benchmark Imaging Dataset (ABID)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.","conditions":["Age-Related Macular Degeneration"],"keywords":["screening","artificial intelligence","AI"],"interventions":[{"type":"OTHER","name":"Retinal Imaging"}],"enrollment":1000,"startDate":"2025-05-12","completionDate":"2027-06","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants greater than or equal to 50 years of age at time of signing Informed Consent Form\n* Willing to comply with all study procedures and sign the Informed Consent Form (ICF)\n* Individuals with normal healthy eyes or diagnosed with any stage of Age-Related Macular Degeneration (treatment naïve patients with early, intermediate, or late AMD). The diagnosis and eligibility review will be confirmed by Central Reading Center.\n\nExclusion Criteria:\n\n* Therapeutic treatment for any type of AMD, in either eye. Supplements, such as AREDS2 formula, are allowed.\n* Unable to acquire adequate quality images, as evaluated by the Central Reading Center\n* Severe vision loss requiring urgent surgery\n* Contraindicated for acquiring retinal images due to narrow anterior chamber angles or hypersensitivity to light\n* A systemic or ocular condition that in the opinion of the Investigator would preclude participation in the study\n* Unwilling to sign informed consent form\n* Currently or previously enrolled in an interventional AMD clinical trial","locations":[{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bergstrom Eye Research LLC","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erie Retina Research","city":"Erie","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Foundation of the Southwest","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Retina Institute","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas (Houston)","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah - John A. Moran Eye Center","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Station Eye Care Clinic","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charles Research Center","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Adelaide Eye and Retina Centre","city":"Adelaide","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Bonn - Department of Ophthalmology","city":"Bonn","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sankara Nethralaya, Medical Research Foundation","city":"Chennai","state":"Tamil Nadu","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aravind Eye Hospital","city":"Chennai","state":"Tamil Nadu","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aga Khan University","city":"Karachi","state":"","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kim Eye Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wisconsin Reading Center","phone":"1-608-262-1334","email":"wrc.support@wisc.edu"}],"primaryOutcomes":["AMD Classification by Participant Count","Geographic Location by Participant Count"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","fargo-north-dakota","erie-pennsylvania","dallas-texas","mcallen-texas","the-woodlands-texas","salt-lake-city-utah","madison-wisconsin","buenos-aires-argentina","adelaide-australia","bonn-germany","chennai-india","karachi-pakistan","seoul-south-korea"],"enrichment":{"headline":"Not a traditional drug phase: Retinal Imaging for Age-Related Macular Degeneration","inPlainEnglish":"1000 participants from up to 25 international locations who are at least 50 years old with either healthy eyes or a diagnosis of Age-Related Macular Degeneration (AMD) will be consented to provide images of their eyes for a new dataset. This dataset is an important step in developing an Artificial Intelligence (AI) based screening tool for AMD.","whoItsFor":["Ages 50 Years to any","Individuals with normal healthy eyes or diagnosed with any stage of Age-Related Macular Degeneration (treatment naïve patients with early, intermediate, or late AMD). The diagnosis and eligibility review will be confirmed by Central Reading Center"],"whoShouldSkip":["Therapeutic treatment for any type of AMD, in either eye. Supplements, such as AREDS2 formula, are allowed","Unable to acquire adequate quality images, as evaluated by the Central Reading Center","Severe vision loss requiring urgent surgery","Contraindicated for acquiring retinal images due to narrow anterior chamber angles or hypersensitivity to light","A systemic or ocular condition that in the opinion of the Investigator would preclude participation in the study","Currently or previously enrolled in an treatment AMD clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 15 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.144Z"},{"nctId":"NCT06926790","title":"Neoadjuvant Nivolumab Plus Ipilimumab in Resectable NSCLC (GALAXY 3)","officialTitle":"Neoadjuvant Nivolumab Plus Ipilimumab in Resectable Non-small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The First Affiliated Hospital of Guangzhou Medical University","sponsorClass":"OTHER","summary":"Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, conventional chemotherapy components may increase treatment-related toxicity, particularly in elderly populations. Additionally, the efficacy of preoperative immunochemotherapy for patients with PD-L1 expression \\<1% remains to be improved. Emerging evidence has demonstrated that the combination of nivolumab (anti-PD-1) and ipilimumab (anti-CTLA-4) provides superior responses in the treatment of advanced NSCLC. However, the safety and efficacy of this strategy in the neoadjuvant setting remain controversial. Therefore, this single-arm clinical trial aims to evaluate the safety and feasibility of neoadjuvant nivolumab plus ipilimumab followed by surgery in treating locally advanced and resectable NSCLC.","conditions":["Lung Cancer - Non Small Cell"],"keywords":["lung cancer","nivolumab plus ipilimumab","neoadjuvant treatment","non-small cell lung cancer"],"interventions":[{"type":"DRUG","name":"Nivolumab & Ipilimumab"}],"enrollment":69,"startDate":"2025-06-19","completionDate":"2030-03-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Informed consent must be signed.\n2. At least 18 years of age.\n3. Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation).\n4. Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%.\n5. disease eligible for surgery.\n6. No previous systematic therapy or radiotherapy.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. At least one measurable lesion.\n9. No major organ dysfunction, including liver, kidney, and cardiac function.\n\nExclusion Criteria:\n\n1. Patients with active autoimmune disease or history of autoimmune disease.\n2. Patients have received other treatment for non-small cell lung cancer or for any other malignancy.\n3. History of allergy to study drug components.\n4. Pregnant or breast-feeding.\n5. Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information.\n6. Patients who have other malignancies.\n7. History of major surgery or serious injury within the past 3 months.\n8. HIV, HBV, HCV infection or active pulmonary tuberculosis.\n9. Vaccination within 4 weeks prior to the start of the study.\n10. Presence of underlying medical conditions that, in the investigator's judgment, could increase the risk associated with study drug administration or interfere with the assessment of toxicity and adverse events.","locations":[{"facility":"First Affiliated Hospital of Guangzhou Medical University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shuben Li, Professor","phone":"020-8306-2114","email":"13500030280@163.com"}],"primaryOutcomes":["Pathological Complete Response (PCR)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: testing Nivolumab & Ipilimumab for Lung Cancer - Non Small Cell","inPlainEnglish":"Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, conventional chemotherapy components may increase treatment-related toxicity, particularly in elderly populations.","whoItsFor":["Ages 18 Years to 80 Years","At least 18 years of age","Histologically or cytologically confirmed non-small cell lung cancer (without EGFR, ALK mutation)","Have measurable and clinical stage II-IIIA with no known PD-L1 expression or PD-L1 ≤ 1%","disease eligible for surgery","No previous systematic therapy or radiotherapy","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","At least one measurable lesion"],"whoShouldSkip":["Patients with active autoimmune disease or history of autoimmune disease","Patients have received other treatment for non-small cell lung cancer or for any other malignancy","History of allergy to study drug components","Pregnant or breast-feeding","Any mental or psychological condition that would prevent the patient from completing the study or understanding the patient information","Patients who have other malignancies","History of major surgery or serious injury within the past 3 months"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab & Ipilimumab. The registry lists allocation as na. Neoadjuvant immunotherapy followed by surgery has emerged as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 69 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.986Z"},{"nctId":"NCT06926829","title":"A Long-term Trial of EB-1020 in Adult Patients With ADHD","officialTitle":"A Phase 3, Multicenter, Open-label, Uncontrolled, Long-term Trial to Evaluate the Safety and Efficacy of Long-term Administration of EB-1020 Once Daily QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Otsuka Pharmaceutical Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the double-blind trial (405-102-00112) conducted in Japan","conditions":["Attention Deficit Hyperactivity Disorder (ADHD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"EB-1020 (Centanafadine) 164.4 mg"},{"type":"DRUG","name":"EB-1020 (Centanafadine) 328.8 mg"}],"enrollment":180,"startDate":"2025-06-25","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who completed the treatment period andfollow-up period in the preceding double-blind parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP).\n* Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding double-blind parent trial.\n\nExclusion Criteria:\n\n* Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit.\n* Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial.\n* Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:\n\n  * Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding double-blind parent trial or\n  * Reported suicidal behavior\n* Participants who were found to have serious or severe adverse events that were judged to be related to the IMP in the preceding double-blind parent trial.\n* Participants who test positive for drugs or alcohol in a urine test on baseline visit.","locations":[{"facility":"Maynds Tower Mental Clinic","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Drug Information Center","phone":"+81-3-6361-7314","email":""}],"primaryOutcomes":["Number of Patients Experiencing Treatment-Emergent Adverse Events (TEAEs)"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["tokyo-japan"],"enrichment":{"headline":"Phase 3: testing EB-1020 (Centanafadine) 164.4 mg for Attention Deficit Hyperactivity Disorder (ADHD)","inPlainEnglish":"This study wants to measure the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the neither you nor the study doctors know who gets the real treatment trial (405-102-00112) conducted in Japan","whoItsFor":["Ages 18 Years to 55 Years","Participants who completed the treatment period andfollow-up period in the preceding neither you nor the study doctors know who gets the real treatment parent Trial (Trial 405-102-00112) and did not meet the criteria for discontinuation of the investigational medicinal product (IMP)","Participants who have not been found to have major problems with trial requirements, such as compliance with the IMP, in the preceding neither you nor the study doctors know who gets the real treatment parent trial"],"whoShouldSkip":["Participants who are pregnant or breastfeeding or test positive for pregnancy on baseline visit","Participants who started prohibited concomitant medications/therapies for ADHD or other comorbidities at the end of the follow-up period of the preceding trial, or participants for whom starting treatment is deemed beneficial","Participants who have a significant risk of committing suicide in the opinion of the investigator or subinvestigator, or based on the following evidence:","Active suicidal ideation as evidenced by an answer of \"yes\" on Questions 4 or 5 on the section of suicidal ideation on the since last visit version of the Columbia-Suicide Severity Rating Scale (C-SSRS) in the preceding neither you nor the study doctors know who gets the real treatment parent trial or","Reported suicidal behavior","Participants who were found to have serious or severe side effects that were judged to be related to the IMP in the preceding neither you nor the study doctors know who gets the real treatment parent trial","Participants who test positive for drugs or alcohol in a urine test on baseline visit"],"whatHappens":"If you join, the listed intervention(s) are EB-1020 (Centanafadine) 164.4 mg, or EB-1020 (Centanafadine) 328.8 mg. The registry lists allocation as randomized. This study wants to measure the safety of long-term administration of mainly high doses of EB-1020 over 52 weeks in patients who have completed the neither you nor the study doctors know who gets the real treatment trial (405-102-00112) conducted in Japan","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 180 people at Tokyo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.650Z"},{"nctId":"NCT06928116","title":"Heat thErapy And mobiLity in COVID-19 Survivors","officialTitle":"Physical Rehabilitation of Long COVID by Heat Therapy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Nebraska","sponsorClass":"OTHER","summary":"Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC. This clinical trial seeks to establish the tolerability and efficacy of at home lower-body heat therapy for improving functional capacity along with metabolic and vascular health in late-middle aged and older adults with PASC, also known as \"long COVID\".","conditions":["Long COVID"],"keywords":["Heat Therapy","mobility limitations","Post-acute sequelae of SARS-CoV-2 infection (PASC)"],"interventions":[{"type":"BEHAVIORAL","name":"Heat therapy"},{"type":"BEHAVIORAL","name":"Sham Control"},{"type":"BEHAVIORAL","name":"Walking"}],"enrollment":99,"startDate":"2025-01-16","completionDate":"2028-08-31","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Between the ages of 50 and 90 years\n* Free from orthopedic limitations that would prohibit performing leg exercise\n* BMI \\< 40 kg/m2 and weigh \\< 400lbs\n* Previously contracted Covid-19 and have persistent symptoms such as a fatigue or decline in physical function, for at least 2 months following SARS-CoV-2 infection\n\nExclusion Criteria:\n\n* Unable to give written informed consent\n* Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months\n* Claustrophobia\n* Orthopedic limitations that would prohibit them from walking\n* Currently enrolled in an exercise-based or respiratory muscle rehabilitation program.","locations":[{"facility":"University of Nebraska Omaha","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gwenael Layec, PhD","phone":"402-554-3779","email":"unovrl@unomaha.edu"}],"primaryOutcomes":["6 min walking distance","Short Physical Performance Battery Test","Arterial stiffness"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["omaha-nebraska"],"enrichment":{"headline":"Not a traditional drug phase: Heat therapy for Long COVID","inPlainEnglish":"Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities. Although exercise intervention is a common strategy to restore functional capacity, it may not be feasible or enticing to many people with PASC.","whoItsFor":["Ages 50 Years to 90 Years","Between the ages of 50 and 90 years","Free from orthopedic limitations that would prohibit performing leg exercise","body-mass index (BMI) \\< 40 kg/m2 and weigh \\< 400lbs","Previously contracted Covid-19 and have persistent symptoms such as a fatigue or decline in physical function, for at least 2 months following SARS-CoV-2 infection"],"whoShouldSkip":["Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months","Orthopedic limitations that would prohibit them from walking","Currently enrolled in an exercise-based or respiratory muscle rehabilitation program"],"whatHappens":"If you join, the listed intervention(s) are Heat therapy, Sham Control, or Walking. The registry lists allocation as randomized. Post-acute sequelae of SARS-CoV-2 infection (PASC) is becoming a major risk factor for chronic diseases, with older adults and those with underlying health conditions at risk of developing persistent mobility limitations and disabilities.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 99 people at Omaha. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.238Z"},{"nctId":"NCT06928272","title":"Long Covid (LC)-REVITALIZE - A Long Covid Repurposed Drug Study","officialTitle":"LC-REVITALIZE - A Long Covid Repurposed Drug Study","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Douglas D. Fraser","sponsorClass":"OTHER","summary":"The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, South Africa, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months. The main goal of the study is to determine whether the drug treatments can improve symptoms in five key areas: 1) fatigue, 2) breathing, 3) memory, thinking, and communication, 4) muscle and joint pain, and 5) circulation. A secondary goal is to assess changes in the body, such as reducing inflammation, as well as to confirm the safety and tolerability of the treatments. In the first phase, 348 participants will take either one of two existing medications (upadacitinib or pirfenidone) or a placebo (a pill with no active ingredient) for three months. Although these medications are not yet approved for Long Covid, they are authorized for use in treating other health conditions. This study is adaptive, meaning it may adjust based on early results. In the second phase, the study could continue testing the most effective drug(s) against a placebo with new participants, explore combinations of drugs to see if they improve results, or discontinue the drugs if they prove ineffective or unsafe and test alternative treatments.","conditions":["Long COVID"],"keywords":["Post-Covid-19 Condition","Covid-19","SARS-CoV-2"],"interventions":[{"type":"DRUG","name":"Pirfenidone"},{"type":"DRUG","name":"Placebo for pirfenidone"},{"type":"DRUG","name":"Upadacitinib"},{"type":"DRUG","name":"Placebo for upadacitinib"}],"enrollment":348,"startDate":"2025-09-10","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nEligible participants must meet all the following inclusion criteria:\n\n1. Adults ≥ 18 years of age and ≤ 65 years of age\n2. Previous Covid-19 (SARS-CoV-2 infection) within the past four years, as determined by the site investigator using the following certainty scale (based on available clinical history and/or serologic data):\n\n3 - Confirmed Infection (PCR or n-Capsid Test): Prior positive nasopharyngeal or salivary PCR test for Covid-19 (documented proof and/or verbal confirmation by participant) or has positive nucleocapsid antibodies results.\n\n2 - Probable Infection (Antigen Test): Participant verbally confirms a prior positive rapid antigen test without PCR confirmation.\n\n1 - Possible Infection (Viral Syndrome and Epidemiological Link): Participant verbally confirms experiencing symptoms consistent with Covid-19 infection and has an epidemiological link (i.e., exposure to a confirmed case) without any positive testing.\n\n3\\. Persistent or new symptoms diagnosed as \"Long Covid\" as defined by the World Health Organization; \"the continuation or development of new symptoms 3 months after the initial SARS-CoV-2 infection (Covid-19), with these symptoms lasting for at least 2 months with no other explanation\". This diagnosis may come from a healthcare professional experienced in Long Covid diagnosis, or the site investigator. These symptoms must be present for more days than not and must not have been present prior to the onset of SARS-CoV-2 (Covid-19) infection.\n\n4\\. At the time of screening, participants should be experiencing at least one of the following self-reported symptoms or symptom clusters. Participant has self-reported issues with:\n\n1. Fatigue\n2. Breathing\n3. Circulation\n4. Memory, thinking, and/or communication\n5. Muscles and/or joints\n\n   These five symptoms or symptom clusters were selected based on unpublished data from the National Institutes for Health and Care Research (NIHR, United Kingdom) and their alignment with five validated SBQ scales. The selection was driven by their prevalence and their significant impact on quality of life as reported in symptom assessments.\n\n   5\\. Participant has the ability and is willing to follow study procedures throughout the study\n\n   6\\. Participant can provide informed consent\n\n   Exclusion Criteria:\n\n   Participants who have any one or more of the following criteria at the time of enrollment will be excluded:\n   1. Participants who do not meet the criteria outlined above\n   2. Participants who are unable to provide their informed consent\n   3. Participants who are pregnant, lactating, or plan to become pregnant during the time of the study\n   4. Persons of childbearing potential who are unwilling or unable to abstain from sex or to use at least one acceptable method of contraception from the time of screening through at least 30 days after the end of the study intervention period. Acceptable methods include barrier contraceptives (e.g., condoms or diaphragm) with spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive pills, and surgical sterilization. Participants unwilling to be counseled about the risks related to pregnancy or breastfeeding will also be excluded.\n   5. Male participants must take precautions to avoid impregnating a female while participating in this study. If a male participant's partner can become pregnant, she must use an effective and reliable form of birth control, as listed above, during the study and for 30 days after the male participant's last dose of the investigational product. Additionally, male participants must agree to use a latex condom during sexual activity with partners who could become pregnant.\n   6. eGFR \\<30 mL/min/1.73m2\n   7. Moderate to severe liver dysfunction, defined as Bilirubin \\> 1.5 x ULN or AST or ALT \\> 2 x ULN\n   8. Hemoglobin (Hbg) \\< 8.0 g/dL\n   9. Absolute neutrophil count (ANC) below 1,000 cells/mm³, confirmed with repeat testing\n   10. Absolute lymphocyte count (ALC) below 500 cells/mm³\n   11. Alkaline phosphatase (ALP) levels equal to or greater than three times the upper limit of normal (ULN)\n   12. Creatine phosphokinase (CPK) levels equal to or greater than three times the ULN\n   13. Platelet count below 100,000 cells/mm³, confirmed with repeat testing\n   14. Platelet count above 500,000 cells/mm³, confirmed with repeat testing\n   15. Total fasting cholesterol levels of 280 mg/dL or higher, confirmed with repeat testing\n   16. Fasting low-density lipoprotein (LDL) levels of 180 mg/dL or higher, confirmed with repeat testing\n   17. A personal or family history of long QT syndrome or an electrocardiogram (ECG) during screening showing a corrected QT interval (QTc) of 500 milliseconds or greater, calculated using Fridericia's formula\n   18. Participants with HIV diagnosis\n   19. Participants with active hepatitis B or C diagnosis. Note: treated or cleared hepatitis C is not exclusionary.\n   20. Active herpes zoster infection (visible skin lesions) within 3 months prior to screening, or any history of disseminated or complicated herpes zoster or herpes simplex infection (e.g., VZV encephalitis)\n   21. Participants with active or latent tuberculosis\n   22. Immunocompromised status, as determined by the investigator, that places the participant at an unacceptable risk for study participation\n   23. Active malignancy or lymphoproliferative disorder that has not been in remission for at least five years. Localized non-melanoma skin cancers that have been definitively treated are not exclusionary.\n   24. Positive SARS-CoV-2 test in the last 30 days or symptomatic with Covid-19 like illness\n   25. Previous admission to an intensive care unit (ICU) for the treatment of acute COVID-19 infection\n   26. Any history of deep venous thrombosis, pulmonary embolism, unstable angina, atrial fibrillation, ventricular fibrillation, or myocardial infarction or stroke\n   27. History of sepsis or a significant viral, bacterial, fungal, or parasitic infection within 30 days prior to enrollment, as determined by the investigator.\n   28. Use of one or more of the study drugs within 30 days prior to enrollment for the original indication or other purposes\n   29. Known allergic reactions to the components of the study drugs\n   30. Any prior exposure to JAK inhibitors\n   31. Taking any of the listed medications on the prohibited medications list in Appendix A\n   32. Intake or planned consumption of any of the following: Taurine, Curcumin, CoQ10, Creatine, Resveratrol, Fisetin, Nicotinamide mononucleotide (NMN), Nicotinamide adenine dinucleotide (NAD+), Quercetin, Glycine, Spermidine, Arginine alpha-ketoglutarate, Ergothioneine, Alpha Lipoic Acid, Carnitine, Benfotiamine, Carnosine, Crocin, N-acetylcysteine\n   33. Covid vaccinations are prohibited within 30 days prior to enrollment\n   34. Live vaccine within the 30 days before enrollment or plan to receive live vaccines during the study period\n   35. Other vaccines, including influenza vaccine, are prohibited within 14 days of enrollment\n   36. Major surgery within 30 days prior to enrollment or plans for major surgery during the study\n   37. Any other co-existing medical condition or concomitant medication/therapy that might in the judgment of the study investigators, potentially impact the participant's safety or ability to adhere to the study protocol or interfere with the meaning of the clinical and research measurements as judged by the study investigators\n   38. Participation in any clinical study within the last 30 days prior to enrollment\n   39. Participants who participated in Phase One of this study (LC-Revitalize) are not eligible to participate in Phase Two\n   40. Currently hospitalized and/or incarcerated","locations":[{"facility":"Laura Rodriguez Research Institute","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ini-Fiocruz","city":"Rio de Janeiro","state":"Rio de Janerio","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Recherches Cliniques de Montréal (IRCM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Recherche du CHUS (CRCHUS)","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"INMI Lazzaro Spallanzani IRCCS","city":"Roma","state":"Roma","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sapienza Università di Roma","city":"Roma","state":"Roma","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Università degli Studi di Modena e Reggio Emilia","city":"Modena","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Family Centre for Research with Ubuntu (FAMCRU), Stellenbosch University","city":"Cape Town","state":"Western Cape","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Joint Clinical Research Centre (JCRC)","city":"Kampala","state":"Kampala","country":"Uganda","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Teaching Hospital","city":"Lusaka","state":"Lusaka Province","country":"Zambia","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephanie Perkin","phone":"1-519-685-8500","email":"stephanie.perkin@lhsc.on.ca"}],"primaryOutcomes":["Symptom Burden Questionnaire (SBQ) Subscales"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["san-diego-california","rio-de-janeiro-brazil","montreal-canada","sherbrooke-canada","roma-italy","modena-italy","cape-town-south-africa","kampala-uganda","lusaka-zambia"],"enrichment":{"headline":"Phase 3: testing Pirfenidone for Long COVID","inPlainEnglish":"The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, South Africa, Uganda, the United States, and Zambia. To qualify, participants must have had Covid-19 and experienced Long Covid symptoms for at least three months.","whoItsFor":["Ages 18 Years to 65 Years","Eligible participants must meet all the following who can join:","Adults ≥ 18 years of age and ≤ 65 years of age","Previous Covid-19 (SARS-CoV-2 infection) within the past four years, as determined by the site investigator using the following certainty scale (based on available clinical history and/or serologic data):","3 - Confirmed Infection (PCR or n-Capsid Test): Prior positive nasopharyngeal or salivary PCR test for Covid-19 (documented proof and/or verbal confirmation by participant) or has positive nucleocapsid antibodies results","2 - Probable Infection (Antigen Test): Participant verbally confirms a prior positive rapid antigen test without PCR confirmation","1 - Possible Infection (Viral Syndrome and Epidemiological Link): Participant verbally confirms experiencing symptoms consistent with Covid-19 infection and has an epidemiological link (i.e., exposure to a confirmed case) without any positive testing","4\\. At the time of screening, participants should be experiencing at least one of the following self-reported symptoms or symptom clusters. Participant has self-reported issues with:"],"whoShouldSkip":["Participants who have any one or more of the following criteria at the time of enrollment will be excluded:","Participants who do not meet the criteria outlined above","Participants who are pregnant, lactating, or plan to become pregnant during the time of the study","eGFR \\<30 mL/min/1.73m2","Moderate to severe liver dysfunction, defined as Bilirubin \\> 1.5 x ULN or AST or ALT \\> 2 x ULN","Hemoglobin (Hbg) \\< 8.0 g/dL","Absolute neutrophil count (ANC) below 1,000 cells/mm³, confirmed with repeat testing"],"whatHappens":"If you join, the listed intervention(s) are Pirfenidone, Placebo for pirfenidone, or Upadacitinib. The registry lists allocation as randomized. The Long-Covid (LC)-Revitalize clinical study is testing repurposed drug treatments for Long Covid, involving adult participants from Brazil, Canada, Italy, South Africa, Uganda, the United States, and Zambia.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 348 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.237Z"},{"nctId":"NCT06928506","title":"Effect of Hi-OxSR for the Treatment of Post COVID Condition","officialTitle":"RECLAIM: Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hi-OxSR for the Treatment of Post COVID Condition (RECLAIM-HiOxSR)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Health Network, Toronto","sponsorClass":"OTHER","summary":"The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects. We conducted a pilot study assessing the open label use of re-breathing CO2 (using Hi-OxSR) twice a day for 14 days, for the treatment of post-COVID cognitive dysfunction. Significant improvements were found in multiple cognitive assessments using TestMyBrain cognitive tests and brain fog (MSNQ) and fatigue scores. This phase 2 clinical trial seeks to build on current findings to determine the optimal effective dose of treatment (i.e. length of use, oxygen concentration, without or without CO2 rebreathing) and the safety of using Hi-OxSR in this patient population.","conditions":["Long COVID","Post COVID-19 Condition","Post Acute Sequelae of COVID-19"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Hi-OxSR device"},{"type":"DEVICE","name":"Hi-Ox device"}],"enrollment":120,"startDate":"2025-08-01","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years;\n2. Positive COVID-19 test by nasopharyngeal swab RT-PCR (reverse transcription polymerase chain reaction) test, antibody or antigen tests at least 3 months prior to randomization; OR Presumed COVID-19 assessed by the site investigator (no positive COVID-19 test) with acute illness after October 15, 2019.\n3. Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial.\n4. Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;\n5. Lingering symptoms from COVID-19 present at the time of randomization. \"Lingering symptoms of Long COVID\" must include self-reported cognitive dysfunction symptoms.\n6. Female patients of childbearing potential (as assessed by the overseeing Investigator) who are sexually active must agree to practice true abstinence or use effective methods of contraception while on study treatment. Effective methods of contraception must be discussed and approved by the overseeing Investigator.\n7. Must be able to provide informed consent and both willing and able to comply with study requirements.\n8. Oxygen saturation on room air ≥92% at screening measured by pulse oximeter.\n\nExclusion Criteria:\n\n1. Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;\n2. Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;\n3. Contraindications to all of the study interventions;\n4. Co-enrolment in another interventional trial (co-enrolment in an observational study is permitted);\n5. Currently pregnant or breastfeeding.\n6. Known physician diagnosis of cognitive dysfunction prior to COVID infection\n7. Use of an investigational drug/device or other interventions within 30 days of screening\n8. Use of home oxygen (O2) at baseline\n9. History of pulmonary hypertension\n10. Interstitial pulmonary fibrosis\n11. Moderate to severe chronic obstructive pulmonary disease (COPD)\n12. History of narcolepsy\n13. Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data.","locations":[{"facility":"Kaye Edmonton Clinic","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Sherbrooke","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"suzanne Cohen","phone":"1-866-673-2524","email":"reclaim@uhn.ca"}],"primaryOutcomes":["Simple reaction time (SRT) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool","Verbal paired associates (VPA) task from the TestMyBrain (TMB) Digital Neuropsychology Toolkit On-line survey tool"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["edmonton-canada","toronto-canada","sherbrooke-canada"],"enrichment":{"headline":"Not a traditional drug phase: Hi-OxSR device for Long COVID","inPlainEnglish":"The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction. Carbon dioxide (CO2) has been proposed as a potential treatment for persistent immune activation as there is evidence that CO2 has antioxidant, anti-inflammatory, and anti-cytokine effects.","whoItsFor":["Ages 18 Years to any","Patients should be treated with standard of care therapies (as discussed in the study manual) for at least 4 weeks prior to entry into trial","Lingering COVID-19 symptoms beyond 3 months from onset of acute COVID and symptoms have lasted at least 2 months. The onset of COVID is considered the earliest of two dates: the date of positive test or the date of first symptoms;","Lingering symptoms from COVID-19 present at the time of randomization. \"Lingering symptoms of Long COVID\" must include self-reported cognitive dysfunction symptoms","Oxygen saturation on room air ≥92% at screening measured by pulse oximeter"],"whoShouldSkip":["Patients who had mechanical ventilation or extracorporeal membrane oxygen (ECMO) for COVID-19;","Current end-organ failure, organ transplantation, or current hospitalization in acute care hospital;","Contraindications to all of the study interventions;","Co-enrolment in another treatment trial (co-enrolment in an watch-and-measure (no experimental treatment required) study is permitted);","Currently pregnant or breastfeeding","Known physician diagnosis of cognitive dysfunction prior to COVID infection","Use of an investigational drug/device or other interventions within 30 days of screening"],"whatHappens":"If you join, the listed intervention(s) are Hi-OxSR device, or Hi-Ox device. The registry lists allocation as randomized. The RECLAIM study platform will be used to explore whether the use of the Hi-OxSR device improves the symptoms of post covid cognitive dysfunction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.232Z"},{"nctId":"NCT06929273","title":"A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)","officialTitle":"A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)\n\nThe primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.","conditions":["Bipolar Disorder Type I With Mania"],"keywords":["Bipolar-I disorder","Mania","Bipolar-I disorder with Mania"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"DRUG","name":"Lithium"},{"type":"DRUG","name":"Valproate"},{"type":"DRUG","name":"Lamotrigine"}],"enrollment":450,"startDate":"2025-07-18","completionDate":"2028-06-13","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  a. Participants must have completed treatment period of parent study.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.\n  2. Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.\n  3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.\n  4. Participants does not require hospitalization for acute mania.\n\nExclusion Criteria:\n\n* All participants:\n\n  1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.\n* Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):\n\n  1\\. Discontinuation from any KarXT parent studies.\n* De novo participants who did not participate in double-blind placebo-controlled studies:\n\n  1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).\n  2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n  3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test.\n  4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n  5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 0120","city":"Glendale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0204","city":"Scottsdale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0205","city":"Tucson","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research - Richardson","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research- Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woodland International Research Group","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woodland Research Northwest","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center Inc.","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0044","city":"Cerritos","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0201","city":"Cerritos","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group - Chino","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proscience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omega Clinical Trials - La Habra","city":"La Habra","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0200","city":"Northridge","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NRC Research Institute","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0136","city":"Santa Ana","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale New Haven Hospital-Smilow Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Synergy Clinical Research","city":"Boynton Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Hallandale Beach","city":"Hallandale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0026","city":"Hialeah Gardens","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Behavioral Clinical Research","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Centers of America ( Hollywood )","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LCC Medical Research Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Clinical Research, Inc.","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Florida Research Phase I-IV","city":"Miami Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0045","city":"St. Petersburg","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel iResearch, LLC","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel iResearch, LLC","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0031","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research -Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0207","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CBH Health","city":"Gaithersburg","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precise Research Centers","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arch Clinical Trials","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0197","city":"Lincoln","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0121","city":"North Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0122","city":"North Las Vegas","state":"Nevada","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Hassman Research Institute Marlton Site","city":"Marlton","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0058","city":"Marlton","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Richmond Behavioral Associates","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0124","city":"Charlotte","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Behavioral Clinical Research","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0202","city":"West Chester","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Community Clinical Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0199","city":"Carrollton","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Dallas","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0046","city":"Houston","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Elevate Clinical Research-Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0036","city":"Irving","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Prime Clinical Research - Mansfield","city":"Mansfield","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research - Richardson","city":"Richardson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0198","city":"Wichita Falls","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0128","city":"ABB","state":"Buenos Aires F.D.","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Morra S.A.","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0126","city":"Mendoza","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0156","city":"Santiago del Estero","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Clinic Northside","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Clinic New Farm","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0188","city":"Kazanlak","state":"Stara Zagora","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Center for Mental Health Prof. Dr. Ivan Temkov","city":"Burgas","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Mental Health - Haskovo","city":"Haskovo","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar","city":"Novi Iskar","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"\"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski\" EAD","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"MHAT \"Dr. Ival Seliminski\"","city":"Sliven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0196","city":"Sofia","state":"","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mental Health Center - Vratsa","city":"Vratsa","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0177","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0174","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0175","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0181","city":"Baoding","state":"Hebei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0184","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0180","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xi An Mental Health Center","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0179","city":"Chengdu","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0183","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0182","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0018","city":"Zagreb","state":"City of Zagreb","country":"Croatia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Klinika za psihijatriju \"Vrapče\"","city":"Zagreb","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psihijatrijska bolnica \"Sveti Ivan\"","city":"Zagreb","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aalborg Universitetshospital Psykiatrien","city":"Gistrup","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Glostrup Hospital","city":"Glostrup Municipality","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0170","city":"Nice","state":"Alpes-Maritimes","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chu Gabriel Montpied","city":"Clermont-Ferrand","state":"Puy-de-Dôme","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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0189","city":"Ternopil","state":"","country":"Ukraine","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Number of participants with treatment emergent adverse events (TEAEs)"],"hasResults":false,"conditionSlugs":["als","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["glendale-arizona","scottsdale-arizona","tucson-arizona","bentonville-arkansas","little-rock-arkansas","rogers-arkansas","anaheim-california","bellflower-california","cerritos-california","chino-california","culver-city-california","garden-grove-california","la-habra-california","montclair-california","northridge-california","orange-california","riverside-california","santa-ana-california","torrance-california","new-haven-connecticut","boynton-beach-florida","hallandale-florida","hialeah-gardens-florida","hollywood-florida","miami-florida","miami-lakes-florida","miami-springs-florida","st-petersburg-florida","atlanta-georgia","decatur-georgia","savannah-georgia","chicago-illinois","indianapolis-indiana","gaithersburg-maryland","flowood-mississippi","st-louis-missouri","lincoln-nebraska","north-las-vegas-nevada","marlton-new-jersey","staten-island-new-york","charlotte-north-carolina","cincinnati-ohio","north-canton-ohio","west-chester-ohio","austin-texas","carrollton-texas","desoto-texas","houston-texas","irving-texas","mansfield-texas","richardson-texas","wichita-falls-texas","abb-argentina","c-rdoba-argentina","mendoza-argentina","santiago-del-estero-argentina","st-leonards-australia","brisbane-australia","kazanlak-bulgaria","burgas-bulgaria","haskovo-bulgaria","novi-iskar-bulgaria","pleven-bulgaria","sliven-bulgaria","sofia-bulgaria","vratsa-bulgaria","beijing-china","guangzhou-china","baoding-china","changsha-china","nanjing-china","xian-china","chengdu-china","tianjin-china","ningbo-china","zagreb-croatia","gistrup-denmark","glostrup-municipality-denmark","nice-france","clermont-ferrand-france","montpellier-france","gy-r-hungary","budapest-hungary","vadodara-india","belagavi-india","kozhikode-india","ludhiana-india","madurai-india","hyderabad-india","kolkata-india","mangalore-india","hod-hasharon-israel","ness-ziona-israel","petah-tikva-israel","ramat-gan-israel","beersheba-israel","ashkelon-israel","jerusalem-israel","milan-italy","pisa-italy","siena-italy","ancona-italy","genova-italy","k-nan-japan","toyoake-japan","ichikawa-japan","iizuka-japan","kitakyushu-japan","obihiro-japan","sapporo-japan","yokohama-japan","moriguchi-japan","sakai-shi-japan","karatsu-shi-japan","iruma-japan","kumagaya-japan","bunkyo-ku-japan","kodaira-japan","tabashi-city-japan","fukuoka-japan","kochi-japan","miyazaki-japan","osaka-japan","tokyo-japan","wakayama-japan","yamagata-japan","auckland-new-zealand","poznan-poland","warsaw-poland","bialystok-poland","gdansk-poland","rybnik-poland","tuszyn-poland","bucharest-romania","ia-i-romania","sanpetru-brasov-romania","ko-ice-slovakia","vranov-nad-top-ou-slovakia","barcelona-spain","bilbao-spain","nacka-sweden","uppsala-sweden","gothenburg-sweden","smila-ukraine","dnipro-ukraine","skarzhyntsi-ukraine","hlevakha-ukraine","lviv-ukraine","oleksandrivka-ukraine","vinnytsia-ukraine","kropyvnytskyi-ukraine","kyiv-ukraine","odesa-ukraine","poltava-ukraine","ternopil-ukraine"],"enrichment":{"headline":"Phase 3: testing KarXT for Bipolar Disorder Type I With Mania","inPlainEnglish":"This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to measure the long-term whether it is safe and how hard side effects are to live with of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.","whoItsFor":["Ages 18 Years to 65 Years","Participants who participated in neither you nor the study doctors know who gets the real treatment compared with a dummy treatment study (CN0120036, CN0120037, or CN0120046):","a. Participants must have completed treatment period of parent study","De novo participants who did not participate in neither you nor the study doctors know who gets the real treatment compared with a dummy treatment studies:","Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania","Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline","Participants must have CGI-BP score of ≥ 3 at Screening and at baseline","Participants does not require hospitalization for acute mania"],"whoShouldSkip":["1\\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS","Participants who participated in neither you nor the study doctors know who gets the real treatment compared with a dummy treatment study (CN0120036, CN0120037, or CN0120046):","1\\. Discontinuation from any KarXT parent studies","De novo participants who did not participate in neither you nor the study doctors know who gets the real treatment compared with a dummy treatment studies:","Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year)","Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test","Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months"],"whatHappens":"If you join, the listed intervention(s) are KarXT, Lithium, or Valproate. The registry lists allocation as na. This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to measure the long-term whether it is safe and how hard side effects are to live with of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 450 people at 177 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.735Z"},{"nctId":"NCT06929507","title":"Impact of Intravitreal Faricimab on Renal Function in Diabetic Patients","officialTitle":"The Impact of Intravitreal Injection of Anti-vascular Endothelial Growth Factor Faricimab on Renal Function in Patients With Diabetes Mellitus","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Alexandroupolis","sponsorClass":"OTHER","summary":"This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration. It is known that previous anti-VEGF agents has systematic absorption and may cause deterioration in renal function of the patients. However, the effect of Faricimab on kidney function has not been investigated yet. Taking into account that Ang-2 has destructive effect on kidneys, the investigation of the effect of its inhibition in diabetic patients who have already renal function deterioration may provide a valuable information in scientific community.","conditions":["Renal Function Disorder","Diabetic Macular Edema (DME)","Neovascular Age Related Macular Degeneration"],"keywords":["renal function","intravitreal injection of anti-VEGF","faricimab","diabetic macular edema","diabetes mellitus"],"interventions":[{"type":"DRUG","name":"Intravitreal injection of Faricimab or Aflibercept 2 mg"}],"enrollment":60,"startDate":"2025-03-10","completionDate":"2026-03-10","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with diabetes\n* Patients with DME or nAMD or macular edema secondary to retinal vein occlusion\n* Patients already receiving nephroprotective drugs\n\nExclusion Criteria:\n\n* Patients with end stage renal disease\n* Pregnancy\n* Patients with other retinal disorders\n* Previous renal transplantation Patients under hemodialysis","locations":[{"facility":"University Hospital of Alexandroupolis","city":"Alexandroupoli","state":"Evros","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Alexandroupolis","city":"Alexandroupoli","state":"","country":"Greece","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Asli Perente, Dr","phone":"+306951577205","email":"asli_perende-90@hotmail.com"}],"primaryOutcomes":["eGFR","ACR ration"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["alexandroupoli-greece"],"enrichment":{"headline":"Not a traditional drug phase: testing Intravitreal injection of Faricimab or Aflibercept 2 mg for Renal Function Disorder","inPlainEnglish":"This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients. Faricimab is a new anti-VEGF drug which inhibits both VEGF-A and Ang-2 and it is used for the treatment of diabetic macular edema and neovascular age related macular degeneration.","whoItsFor":["Patients with diabetes","Patients with DME or nAMD or macular edema secondary to retinal vein occlusion","Patients already receiving nephroprotective drugs"],"whoShouldSkip":["Patients with end stage renal disease","Patients with other retinal disorders","Previous renal transplantation Patients under hemodialysis"],"whatHappens":"If you join, the listed intervention(s) are Intravitreal injection of Faricimab or Aflibercept 2 mg. The registry lists allocation as randomized. This study aims to investigate the impact of intravitreal injection of anti-vascular endothelial growth factor (anti VEGF) Faricimab on renal function of diabetic patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.135Z"},{"nctId":"NCT06930131","title":"Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia","officialTitle":"Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Toulouse","sponsorClass":"OTHER","summary":"The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. In addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life. This research is a prospective, randomized controlled, open-label, single-centre study. It is part of the management of patients with aphasia who have suffered a cerebral infarction and aims to evaluate the effect of combined language semantics/metacognition rehabilitation.","conditions":["Aphasia","Stroke"],"keywords":["Aphasia","Stroke","Chronic","Cognitive rehabilitation","SCED"],"interventions":[{"type":"BEHAVIORAL","name":"Semantic rehabilitation"}],"enrollment":18,"startDate":"2025-02-21","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* First cerebral infarction\n* Chronic phase (\\> 3 months)\n* Patient affiliated to a health insurance scheme\n* Usual french language\n* Severity score measures using the Boston Diagnostic Aphasia Examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2)\n\nExclusion Criteria:\n\n* Contraindication to undergoing brain MRI\n* Cognitive impairment pre-existing stroke (CQI code \\> 3.4) (Law et al., 1995)\n* Chronic alcohol or drug abuse\n* Unstabilised psychiatric illness\n* Uncorrected sensory deficits\n* Diagnosed as having a progressive general pathology","locations":[{"facility":"University Hospital of Toulouse","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lola DANET","phone":"05 61 77 76 86","email":"danet.l@chu-toulouse.fr"}],"primaryOutcomes":["Performance at the \"TD-264\" untrained naming items task"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["toulouse-france"],"enrichment":{"headline":"Not a traditional drug phase: Semantic rehabilitation for Aphasia","inPlainEnglish":"The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks. In addition, it could potentiate the generalisation of effects to verbal and non-verbal communication skills, having a direct impact on patients' quality of life.","whoItsFor":["Ages 18 Years to any","First cerebral infarction","Chronic phase (\\> 3 months)","Patient affiliated to a health insurance scheme","Usual french language","Severity score measures using the Boston Diagnostic Aphasia Examination battery scale corresponding to the mild or moderate level (score greater than or equal to 2)"],"whoShouldSkip":["Contraindication to undergoing brain MRI","Cognitive impairment pre-existing stroke (CQI code \\> 3.4) (Law et al., 1995)","Chronic alcohol or drug abuse","Unstabilised psychiatric illness","Uncorrected sensory deficits","Diagnosed as having a progressive general pathology"],"whatHappens":"If you join, the listed intervention(s) are Semantic rehabilitation. The registry lists allocation as randomized. The postulate of this study is that rehabilitation combining linguistic and metacognitive training will result in a significant improvement in language performance correlated with changes in functional cerebral connectivity networks.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 18 people at Toulouse. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.655Z"},{"nctId":"NCT06930352","title":"Ziftomenib for the Treatment of Patients With NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia Not Eligible for Standard Therapy","officialTitle":"Frontline Ziftomenib in NPM1-Mutated or KMT2A-Rearranged Acute Myeloid Leukemia in Patients Not Eligible for Intensive Induction or Other Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Uma Borate","sponsorClass":"OTHER","summary":"This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.","conditions":["Acute Myeloid Leukemia"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"DRUG","name":"Cytarabine"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Hydroxyurea"},{"type":"PROCEDURE","name":"Leukapheresis"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"DRUG","name":"Ziftomenib"}],"enrollment":70,"startDate":"2027-01-15","completionDate":"2028-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) Classification:\n\n  * Treatment-naïve acute myeloid leukemia\n  * KMT2A rearrangement (defined as KMT2A translocations) OR NPM1 mutation (defined as NPM1 mutation resulting in cytoplasmic localization, or NPM1c) OR other mutations that have been shown to exhibit sensitivity to menin inhibition. Mutation status will be known from initial diagnosis using standard of care testing, which can be performed locally\n* Patients ineligible or unwilling to receive standard of care induction therapy, such as 7+3, hypomethylating agent, venetoclax, or other standard of care (SOC) regimens with ineligibility defined by the following:\n\n  * ≥ 75 years of age with both of the following;\n\n    * Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection\n    * Subject must have adequate liver function as demonstrated by aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (unless considered due to leukemic organ involvement) OR\n  * ≥ 18 to 74 years of age with at least one of the following co-morbidities:\n\n    * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3;\n    * Cardiac history of congestive heart failure (CHF) requiring treatment or ejection fraction ≤ 50% or chronic stable angina;\n    * Diffusion capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%;\n    * Creatinine clearance ≥ 30 mL/min to \\< 45 ml/min;\n    * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 x ULN;\n    * Venous thromboembolism benefitting from prolonged anticoagulation or presence of prosthetic heart valve or any indication for therapeutic anticoagulation with a single agent\n    * Prior history of severe infection requiring hospitalization with risk of recurrence with subsequent immunosuppression\n    * Any other comorbidity that the physician judges to be incompatible with standard frontline therapy must be reviewed and approved by the study team before study enrollment\n* Peripheral white blood cell (WBC) counts ≤ 10,000/uL. Patients may receive hydroxyurea, cytarabine, or leukapheresis to control and maintain white blood cell count until the end of cycle 1\n* Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 180 days after the last dose of study treatment\n* Non-sterile male patients must agree to use a highly effective method of contraception with partner(s) throughout the study and for at least 90 days after the last dose of study treatment\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia\n* Diagnosis of chronic myelogenous leukemia in blast crisis\n* Clinically active central nervous system (CNS) leukemia\n* Prior treatment for AML except for hydroxyurea and/or cytarabine used for control of leukocytosis\n* Treatment with concomitant drugs that are strong inhibitors or inducers of cytochrome P450-isozyme 3A4 (CYP3A4) with the exception of antibiotics, antifungals, and antivirals that are used as standard of care or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient\n* Detectable viral load for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen indicative of active infection. Patients with controlled disease will not be excluded from study enrollment\n* Pre-existing disorder predisposing the patient to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to AML)\n* Active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection\n* Mean Fridericia's formula-corrected QT interval (QTcF) \\> 480 ms on triplicate electrocardiogram (ECG)\n* Any psychiatric illness that prevents patient from informed consent process\n* Women who are pregnant or lactating. All female patients with reproductive potential must have a negative serum pregnancy test within 72 hours prior to starting treatment\n* Participants requiring dual antiplatelet therapy","locations":[{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ohio State University Comprehensive Cancer Center","phone":"800-293-5066","email":"OSUCCCclinicaltrials@osumc.edu"}],"primaryOutcomes":["Complete remission (CR) plus CR/response with hematologic improvement"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Phase 2: testing Cytarabine for Acute Myeloid Leukemia","inPlainEnglish":"This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene.","whoItsFor":["Ages 18 Years to any","Morphologically confirmed diagnosis of the following based on 2022 World Health Organization (WHO) Classification:","Treatment-naïve acute myeloid leukemia","Patients ineligible or unwilling to receive standard of care induction therapy, such as 7+3, hypomethylating agent, venetoclax, or other standard of care (SOC) regimens with ineligibility defined by the following:","≥ 75 years of age with both of the following;","Subject must have adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection","Subject must have adequate liver function as demonstrated by aspartate aminotransferase (AST) ≤ 3.0 x upper limit of normal (ULN) and alanine aminotransferase (ALT) ≤ 3.0 x ULN (unless considered due to leukemic organ involvement) OR","≥ 18 to 74 years of age with at least one of the following co-morbidities:"],"whoShouldSkip":["Diagnosis of acute promyelocytic leukemia","Diagnosis of chronic myelogenous leukemia in blast crisis","Clinically active central nervous system (CNS) leukemia","Prior treatment for AML except for hydroxyurea and/or cytarabine used for control of leukocytosis","Detectable viral load for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen indicative of active infection. Patients with controlled disease will not be excluded from study enrollment","Pre-existing disorder predisposing the patient to a serious or life-threatening infection (e.g. cystic fibrosis, congenital or acquired immunodeficiency, bleeding disorder, or cytopenias not related to AML)","Active uncontrolled acute or chronic systemic fungal, bacterial, viral, or other infection"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Marrow Aspiration, or Bone Marrow Biopsy. The registry lists allocation as na. This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at Columbus. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.825Z"},{"nctId":"NCT06930508","title":"Bringing Medicines for HIV Prevention to a Family Planning Clinic","officialTitle":"Implementing HIV Pre-Exposure Prophylaxis in a Family Planning Clinic: A Study of Feasibility and Acceptability (Aka The Pilot Fish Study)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Women and Infants Hospital of Rhode Island","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP. The main questions to answer are:\n\n1. Do patients find it acceptable to be asked about, and offered, PrEP during their visit to a family planning clinic?\n2. What things make it easier or harder to ask about PrEP in a family planning clinic setting?\n3. What things make it easier or harder to begin PrEP in a family planning clinic setting?\n\nPatient participants:\n\n1. Will receive standardized counseling about PrEP.\n2. Will have the opportunity to begin PrEP as part of their routine, ongoing care.\n3. Will be asked to complete a survey about their experiences.\n\nPhysician participants:\n\n1. Will receive standardized education about PrEP.\n2. Will talk to patient participants about PrEP, and support patient participants who want to begin PrEP.\n3. Will be asked to complete pre-and post-study surveys about their experiences.\n4. May be asked to complete a post-study in-depth interview about their experiences.","conditions":["HIV","PrEP"],"keywords":["HIV PrEP screening","HIV PrEP initiation","ob/gyn"],"interventions":[{"type":"BEHAVIORAL","name":"Patient participant screening"},{"type":"BEHAVIORAL","name":"Physician participant training"}],"enrollment":83,"startDate":"2026-05-28","completionDate":"2026-12-15","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"This study will include patient participants who:\n\n* Are age 16 or older\n* Are presenting for care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n* Speak English or Spanish\n* Have decisional capacity\n\nThis study will exclude patient participants who:\n\n\\- Are currently seeking abortion care\n\nThis study will include physician participants who:\n\n\\- Provide care at the Women and Infants Hospital of Rhode Island Family Planning Clinic\n\nThis study will not have any specific exclusion criteria for physician participants.","locations":[{"facility":"Women and Infants Hospital of Rhode Island","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Benjamin P Brown, MD, MS","phone":"401-274-1122","email":"benjamin_brown@brown.edu"},{"name":"Erica J Hardy, MD, MMSc, MA","phone":"401-453-7950","email":"erica_hardy@brown.edu"}],"primaryOutcomes":["Acceptability of Intervention Measure","Feasibility of Intervention Measure","Intervention Appropriateness Measure"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["providence-rhode-island"],"enrichment":{"headline":"Not a traditional drug phase: Patient participant screening for HIV","inPlainEnglish":"The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic. These medications are known as pre-exposure prophylaxis, or PrEP.","whoItsFor":["Ages 16 Years to any","This study will include patient participants who:","Are age 16 or older","Are presenting for care at the Women and Infants Hospital of Rhode Island Family Planning Clinic","Have decisional capacity","This study will exclude patient participants who:","\\- Are currently seeking abortion care","This study will include physician participants who:"],"whoShouldSkip":["for physician participants"],"whatHappens":"If you join, the listed intervention(s) are Patient participant screening, or Physician participant training. The registry lists allocation as randomized. The goal of this clinical trial is to understand what patients and physicians think about providing medications to prevent HIV transmission to patients in a family planning clinic.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 83 people at Providence. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.524Z"},{"nctId":"NCT06930560","title":"HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms","officialTitle":"HEARS Neuropsychiatric Symptoms & Hearing Loss: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"This randomized controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.","conditions":["Alzheimer Disease","Dementia","Hearing Loss","Cognitive Impairment"],"keywords":[],"interventions":[{"type":"DEVICE","name":"HEARS-NPS device"},{"type":"BEHAVIORAL","name":"HEARS-NPS program"}],"enrollment":300,"startDate":"2025-10-15","completionDate":"2027-12-31","sex":"ALL","minAge":"60 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 60 - 100 years old\n* English-speaking\n* Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines\n* Speech frequency pure tone average (0.5- 4 kHz) \\>25 db in the better-hearing ear; adult onset hearing loss\n* Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision\n* Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms\n\nExclusion Criteria:\n\n* Current self-reported use of hearing aid or amplification device\n* Medical contraindication to use hearing aids ( e.g. draining ears)\n* Inability to participate in the 1-month follow up","locations":[{"facility":"Johns Hopkins Memory and Alzheimer's Treatment Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Esther Oh, MD, Ph.D.","phone":"410-550-0925","email":"eoh9@jhmi.edu"},{"name":"Jami Trumbo, MSPH","phone":"","email":"jami.trumbo@jhu.edu"}],"primaryOutcomes":["Distress as assessed by the Neuropsychiatric Inventory (NPI-Q)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: HEARS-NPS device for Alzheimer Disease","inPlainEnglish":"This randomly assigned controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD). The community-delivered hearing care intervention utilizes tailored strategies to assess impact on communication, neuropsychiatric symptoms (NPS), and care partner distress.","whoItsFor":["Ages 60 Years to 100 Years","Age 60 - 100 years old","Diagnosis of probable Alzheimer's Disease or other related dementia according to the core clinical criteria outlined in the National Institute on Aging (NIA) and Alzheimer's Association Guidelines","Speech frequency pure tone average (0.5- 4 kHz) \\>25 db in the better-hearing ear; adult onset hearing loss","Availability of caregiver/study partner who is 18+ to participate in all study-related visits and who provides care supervision","Stable (for 2 weeks or longer) dosing of medication (e.g. antidepressants, antipsychotics) for neuropsychiatric symptoms"],"whoShouldSkip":["Current self-reported use of hearing aid or amplification device","Medical contraindication to use hearing aids ( e.g. draining ears)","Inability to participate in the 1-month follow up"],"whatHappens":"If you join, the listed intervention(s) are HEARS-NPS device, or HEARS-NPS program. The registry lists allocation as randomized. This randomly assigned controlled trial study aims to evaluate a revised hearing care intervention for older adults with Alzheimer's Disease and Related Dementias (ADRD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Baltimore. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.324Z"},{"nctId":"NCT06931080","title":"Evaluation of the Efficacy and Safety of EB-1020 in Adult ADHD Patients","officialTitle":"A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled, Trial to Evaluate the Efficacy and Safety of EB-1020 Once Daily QD XR Capsules Administered Orally at Low or High Dose in Adults With Attention-deficit/Hyperactivity Disorder","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Otsuka Pharmaceutical Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.","conditions":["Attention Deficit Hyperactivity Disorder (ADHD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"EB-1020 (Centanafadine) 164.4 mg"},{"type":"DRUG","name":"EB-1020 (Centanafadine) 328.8 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":630,"startDate":"2025-04-30","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants diagnosed primarily with ADHD (excluding other specified or unspecified attention-deficit/hyperactivity disorder) according to DSM-5 criteria, based on information collected through interviews using the Japanese version of the Conners' Adult ADHD Diagnostic Interview for DSM-IVTM (CAADID).\n* Participants with an AISRS total score meeting the following criteria:\n\n  * Not receiving medication treatment for ADHD: 28 points or higher\n  * Receiving medication treatment for ADHD: 22 points or higher\n\nExclusion Criteria:\n\n* Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening.\n* Participants have a current comorbid psychiatric disorder that either could be expected to require treatment with medications prohibited in this trial, or to confound efficacy or safety assessments. Examples include, but are not limited to, psychotic disorder (current or lifetime), bipolar disorder (current or lifetime), generalized anxiety disorder, obsessive-compulsive disorder, panic disorder, a current major depressive episode, or posttraumatic stress disorder, as established by the MINI.\n* Participants diagnosed with a personality disorder according to DSM-5 criteria.\n* Participants diagnosed with autism spectrum disorder according to DSM-5 criteria.\n* Participants diagnosed with intellectual disability and an IQ score below 70.\n* Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:\n\n  • Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a \"\"yes\"\" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline/Screening version at screening.\n* Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria.\n* Participants diagnosed with eating disorders and feeding disorders according to DSM-5 diagnostic criteria.\n* Participants who show a positive reaction in alcohol tests or urine drug tests at screening.\n* Participants with complications or a history of the following neurological disorders:\n\n  * Epilepsy\n  * Seizures (other than infantile febrile seizures)\n  * Syncope\n  * Tourette's disorder\n  * History of significant head trauma with clinically significant loss of consciousness\n  * Dementia\n  * Cerebrovascular disease\n  * Parkinson's disease\n  * Intracranial lesions\n  * Other severe neurological disorders\n* Participants with complications or a history of cardiovascular diseases.\n* Participants with clinical laboratory test results at screening that meet any of the following criteria:\n\n  * Platelets \\<= 75,000/mm3\n  * Hemoglobin \\<= 9 g/dL\n  * Neutrophils, absolute \\<= 1000/mm3\n  * AST \\> 2 x ULN\n  * ALT \\> 2 x ULN\n  * Creatinine \\>= 2 mg/dL\n  * CPK \\>= 2 x ULN (except for the cases that the medical monitor determined that participant's inclusion is possible based on the discussion about the participant's condition with the investigator or subinvestigator) •Abnormal values for both free T4 and TSH•\n* Participants who cannot agree to discontinuation of prohibited concomitant medication, such as ADHD medication or antidepressants.","locations":[{"facility":"Maynds Tower Mental Clinic","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Drug Information Center","phone":"+81-3-6361-7314","email":""}],"primaryOutcomes":["Change from baseline in Adult ADHD Investigator Symptom Rating Scale (AISRS) score at Week6"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["tokyo-japan"],"enrichment":{"headline":"Phase 2 / Phase 3: testing EB-1020 (Centanafadine) 164.4 mg for Attention Deficit Hyperactivity Disorder (ADHD)","inPlainEnglish":"This study wants to measure the how well it works and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.","whoItsFor":["Ages 18 Years to 55 Years","Participants with an AISRS total score meeting the following criteria:","Not receiving medication treatment for ADHD: 28 points or higher","Receiving medication treatment for ADHD: 22 points or higher"],"whoShouldSkip":["Participants who are pregnant or breastfeeding, and those who test positive for pregnancy at screening","Participants diagnosed with a personality disorder according to DSM-5 criteria","Participants diagnosed with autism spectrum disorder according to DSM-5 criteria","Participants diagnosed with intellectual disability and an IQ score below 70","Participants who, in the judgment of the principal or sub-investigator, or based on the following criteria, are at significant risk of suicide:","Clear suicidal ideation or a history of suicidal behavior (within the past 6 months) as indicated by a \"\"yes\"\" answer to questions 4 or 5 in the suicidal ideation section of the C-SSRS Baseline/Screening version at screening","Participants who have a current or past episode of substance-related disorders (excluding tobacco-related disorders) according to DSM-5 diagnostic criteria"],"whatHappens":"If you join, the listed intervention(s) are EB-1020 (Centanafadine) 164.4 mg, EB-1020 (Centanafadine) 328.8 mg, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and examine the safety of two doses of EB-1020 QD XR capsule administered once daily orally in adult ADHD patients.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 630 people at Tokyo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.651Z"},{"nctId":"NCT06931743","title":"The Application of Electrical Stimulation in Postoperative Pain Management of Thyroid Surgery","officialTitle":"Transcutaneous Electrical Nerve Stimulation Based on Wrist-Ankle Acupuncture Theory for Postoperative Pain After Thyroid Surgery: A Multicenter Randomized Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Xiaonan Huang","sponsorClass":"OTHER","summary":"Post-thyroidectomy pain is a prevalent early postoperative complication. While pharmacological agents remain the mainstay of analgesia, their clinical application is constrained by adverse effects including nausea, respiratory depression, and gastrointestinal disturbances. Transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA) is a non-invasive analgesic modality that has demonstrated preliminary benefits in multiple pain scenarios. Nevertheless, robust evidence for its efficacy in post-thyroidectomy pain management is still lacking, limited by single-center designs and small sample sizes in existing studies.\n\nThis trial aims to evaluate the efficacy and safety of TENS-WAA for pain control after thyroidectomy. The findings are expected to support a standardized non-pharmacological analgesic option as an adjunct to multimodal postoperative pain regimens, aligning with Enhanced Recovery After Surgery (ERAS) principles.","conditions":["Thyroid Surgery","Electrical Stimulation","Thyroid Carcinoma"],"keywords":[],"interventions":[{"type":"DEVICE","name":"TENStem eco basic"},{"type":"DEVICE","name":"TENStem eco basic"}],"enrollment":668,"startDate":"2025-04-30","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"1. Inclusion Criteria:\n\n   * Be over 18 years of age;\n   * The operation time is less than 4 hours;\n   * Postoperative VAS pain score ≥3 points ;\n   * Clear consciousness, able to answer questions accurately, free speech, no hearing impairment;\n   * Informed consent\n2. Exclusion Criteria:\n\n   * Neck or thyroid surgery within the past ten years;\n   * Menstruating, pregnant and lactating females;Those who are not satisfied with blood glucose control;\n   * Skin injury or allergy; skin ulceration;\n   * Past history of psychiatric disorder that met the diagnostic criteria of Diagnostic and Manual of Mental Disorders, DSM-IV;\n   * Upper respiratory tract infection within 2 weeks before surgery;\n   * History of implantation of pace or defibrillator;\n   * Allergic to gel or intolerant to electrical stimulation;\n   * History of chronic pain, pain VAS score 1 at the examination;\n   * Use of sedative analgesic drugs for a long time or within 24 hours;\n   * Particip in other clinical trials in the past 4 weeks.","locations":[{"facility":"the Specialised Medical Centre of the Chinese People's Liberation Army Navy","city":"Shanghai","state":"Changning District","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzheng Hospital Affiliated to the Naval Medical University","city":"Shanghai","state":"Huangpu District","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhai Hospital Affiliated to the Naval Medical University","city":"Shanghai","state":"Yangpu District","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ChaoQian Liu","phone":"13761030978","email":"aj04022x@foxmail.com"},{"name":"Jin Du","phone":"18009661988","email":"1352266146@qq.com"}],"primaryOutcomes":["Pain VAS score"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: TENStem eco basic for Thyroid Surgery","inPlainEnglish":"Post-thyroidectomy pain is a prevalent early postoperative complication. While pharmacological agents remain the mainstay of analgesia, their clinical application is constrained by adverse effects including nausea, respiratory depression, and gastrointestinal disturbances.","whoItsFor":["Ages 18 Years to any","Be over 18 years of age;","The operation time is less than 4 hours;","Postoperative VAS pain score ≥3 points ;","Clear consciousness, able to answer questions accurately, free speech, no hearing impairment;"],"whoShouldSkip":["Neck or thyroid surgery within the past ten years;","Menstruating, pregnant and lactating females;Those who are not satisfied with blood glucose control;","Skin injury or allergy; skin ulceration;","Past history of psychiatric disorder that met the diagnostic criteria of Diagnostic and Manual of Mental Disorders, DSM-IV;","Upper respiratory tract infection within 2 weeks before surgery;","History of implantation of pace or defibrillator;","Allergic to gel or intolerant to electrical stimulation;"],"whatHappens":"If you join, the listed intervention(s) are TENStem eco basic, or TENStem eco basic. The registry lists allocation as randomized. Post-thyroidectomy pain is a prevalent early postoperative complication.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 668 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.337Z"},{"nctId":"NCT06932263","title":"Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids","officialTitle":"A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.","conditions":["Asthma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tozorakimab"},{"type":"DRUG","name":"Placebo"}],"enrollment":540,"startDate":"2025-03-26","completionDate":"2027-06-07","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated written informed consent prior to any study-specific procedures.\n2. Adults aged 18-75, inclusive when signing the informed consent.\n3. Documented physician-diagnosis of asthma for at least 12 months.\n4. Treated with medium or high dose ICS in combination with LABA.\n5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .\n6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.\n7. Documented exacerbation history in the last 12 months and biomarker requirements of:\n\n   1. ≥ 2 severe exacerbations OR\n   2. 1 severe exacerbation and:\n\n   (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb\n8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.\n9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.\n10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.\n2. Clinically significant pulmonary disease other than asthma .\n3. Current smokers, former smokers with \\>10 pack-years history.\n4. Clinically significant aortic stenosis or pulmonary arterial hypertension.\n5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.\n6. Unstable cardiovascular disorders.","locations":[{"facility":"Research Site","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huntington Beach","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"La Mesa","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Research Site","city":"Loma Linda","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Jose","state":"California","country":"United 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2: testing Tozorakimab for Asthma","inPlainEnglish":"This is a dose-range finding, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase IIb study designed to assess how well it works and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.","whoItsFor":["Ages 18 Years to 75 Years","Documented physician-diagnosis of asthma for at least 12 months","Treated with medium or high dose ICS in combination with LABA","Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5","Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal","Documented exacerbation history in the last 12 months and biomarker requirements of:","≥ 2 severe exacerbations OR","1 severe exacerbation and:"],"whoShouldSkip":["Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1","Clinically significant pulmonary disease other 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The registry lists allocation as randomized. This is a dose-range finding, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase IIb study designed to assess how well it works and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 540 people at 192 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.351Z"},{"nctId":"NCT06933173","title":"RCT of Mind-body in Long COVID and Myalgic Encephalomyelitis","officialTitle":"Mind-Body in Long COVID and Myalgic Encephalomyelitis Study (MILES): A Patient-Centred RCT","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC). Our team recognizes that ME/CFS and Long COVID are serious, debilitating, biomedical conditions.\n\nME/CFS can affect many different parts of the body, such as the nervous system, immune system, and metabolism. It is hypothesized that central sensitization (i.e., when nerves get too excited) may influence these complex conditions and may make symptoms worse.\n\nThis study explores a mind-body program called the Dynamic Neural Retraining System™, or DNRS™.\n\nMind-body interventions (MBIs) focus on how the brain, mind, body, and behaviour interact to improve health and well-being. These techniques help people become more aware of themselves, take better care of their health, and boost mood, quality of life, and coping skills. MBIs use the brain's ability to change (neuroplasticity) by reinforcing certain thoughts, feelings, or behaviours that support changes in biology and function. MBIs may influence physical health by affecting how the brain and body communicate through chemicals such as hormones and neurotransmitters. Objective fMRI evidence shows that practising MBIs can change brain structure and function. This makes MBIs a potential good fit for people with chronic illnesses like ME/CFS and LC, which involve complex interactions between the brain, immune system, and hormones.\n\nThere is no rigorous peer-reviewed evidence that DNRS is effective. Our study will address this question using subjective and objective measurements in a multiple-methods wait-list randomized controlled trial.\n\nThe objectives of this study are to: 1) examine the effectiveness of the DNRS program for individuals diagnosed with ME/CFS with and without Long COVID, compared to a treatment-as-usual wait-list control group on a range of patient-reported outcomes including health-related quality of life, fatigue, pain, anxiety and depression and objective measures including daily steps, heart rate variability, and sleep; 2) quantify metabolic changes through untargeted serum metabolomics profiling, 3) determine if metabolomics screening can predict treatment responsiveness to DNRS; and 4) identify the microbial signatures of large bowel microbiota in Long COVID patients pre and post MBI.\n\nA descriptive qualitative study will also be conducted in a sample of participants to learn more about their experiences during the trial.","conditions":["Myalgic Encephalomyelitis/Chronic Fatigue Syndrome"],"keywords":["Myalgic encephalomyelitis/Chronic fatigue syndrome","Mind-body intervention","Long COVID","RCT","Patient engagement"],"interventions":[{"type":"OTHER","name":"Dynamic neural retraining system"}],"enrollment":200,"startDate":"2025-07-10","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older;\n* Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months.\n\nExclusion Criteria:\n\nIndividuals who: 1) are too ill to participate; 2) lack reliable internet; 3) cannot communicate in English; 4) Presently have or ever had inflammatory bowel disease; and/or 5) Have been prescribed or used an oral or systemic (infusion) antibiotic in the past one month-;; 6) are participating in a concurrent study; 7) are participating in a concurrent mind-body intervention during the study period including\n\n* Art Therapy\n* Autogenic training\n* Biofeedback/neurofeedback\n* Breathing exercise\n* Cognitive restructuring\n* Dynamic Neural Retraining System\n* Emotional Freedom Techniques (EFT)\n* Eye movement desensitization and reprocessing (EMDR)\n* Guided imagery\n* Hypnotherapy/self-hypnosis\n* Meditation (mindfulness, mantra, guided, transcendental)\n* Mindfulness-based cognitive therapy (MBCT)\n* Mindfulness-based Stress Reduction (MBSR)\n* Music therapy\n* Neurolinguistic programming\n* Psychological flexibility\n* Qigong\n* Relaxation therapy (relaxation response, progressive muscle relaxation)\n* Tai Chi\n* Visualization\n* Yoga and/or starting any other new treatment during the study period, including any mind-body therapy, psychotherapy, prescription medication, over-the-counter medication, etc; 8) have any active medical condition (untreated/uncontrolled) that may explain the presence of fatigue including:\n* untreated hypothyroidism (including Hashimoto's disease)\n* hyperthyroidism\n* diabetes mellitus\n* iron deficiency anemia\n* other treatable anemia\n* iron overload syndrome\n* adrenal insufficiency\n* Cushing's syndrome\n* anorexia nervosa\n* iatrogenic conditions such as side effects or interactions of medication(s) or supplements\n\n  • Rheumatological disorders:\n* rheumatoid arthritis\n* lupus\n* polymyositis\n* polymyalgia rheumatica\n* Sjogren's Syndrome\n* Ehlers Danlos Syndromes \\[Hypermobility type\\]\n\n  • Other heritable disorders of connective tissue:\n* Marfan syndrome\n* Stickler syndrome etc.\n\n  * Multiple sclerosis\n  * Celiac disease\n* Note: Patients with celiac disease can present without gastrointestinal symptoms\n\n  • Immune disorders\n* such as HIV/AIDS\n\n  • Sleep disorders\n* including obstructive sleep apnea\n\n  • Prior illnesses may relapse or may not have completely resolved during treatment.\n* Examples are certain malignancies\n* leukemia\n* infectious diseases such as tuberculosis and chronic hepatitis\n\n  • Active primary psychiatric disorders\n* eating disorders\n* alcohol\n* substance use disorder","locations":[{"facility":"Peter Lougheed Hospital","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta Hospital/Kaye Edmonton Clinic","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"MILES RCT team","phone":"780-680-8907","email":"rctmiles@ualberta.ca"}],"primaryOutcomes":["Physical functioning"],"hasResults":false,"conditionSlugs":["als","depression","long-covid"],"drugSlugs":[],"locationSlugs":["calgary-canada","edmonton-canada"],"enrichment":{"headline":"Not a traditional drug phase: Dynamic neural retraining system for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome","inPlainEnglish":"We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC). Our team recognizes that ME/CFS and Long COVID are serious, debilitating, biomedical conditions.","whoItsFor":["Ages 18 Years to any","Age 18 years or older;","Individuals diagnosed with ME/CFS, according to the Institute of Medicine (2015) criteria, for more than six months"],"whoShouldSkip":["Biofeedback/neurofeedback","Cognitive restructuring","Dynamic Neural Retraining System","Emotional Freedom Techniques (EFT)","Eye movement desensitization and reprocessing (EMDR)","Hypnotherapy/self-hypnosis","Meditation (mindfulness, mantra, guided, transcendental)"],"whatHappens":"If you join, the listed intervention(s) are Dynamic neural retraining system. The registry lists allocation as randomized. We are studying the effect of a mind-body treatment for people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) with or without Long COVID (LC).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.242Z"},{"nctId":"NCT06934239","title":"A Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients","officialTitle":"A Randomized Controlled Trial Comparing Screening Mammography With and Without Assistance From Artificial Intelligence for Breast Cancer Detection and Recall Rates in Adult Patients","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Jonsson Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to compare patient-centered outcomes when screening digital breast tomosynthesis (DBT) exams are interpreted with versus without a leading FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S. settings and to assess patients' and radiologists' perspectives on AI in medicine.\n\nThe main question it aims to answer is: Does an FDA-cleared AI decision-support tool for digital tomosynthesis (DBT) improve screening outcomes in real world US clinical settings?\n\nThis trial will include all interpreting radiologists and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (University of California, Los Angeles (UCLA), University of California, San Diego (UCSD), University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period.\n\nAll screening mammograms at these facilities will be randomized to either intervention (radiologist assisted by an AI decision support tool) versus usual care (radiologist alone) to see if interpreting these mammograms with the AI tool's assistance improves patient screening outcomes.\n\nWe are targeting 400,000 screening exams across the participating health systems in this trial.","conditions":["Breast Cancer Screening","Artificial Intelligence (AI)"],"keywords":["Breast cancer screening","Artificial intelligence (AI)"],"interventions":[{"type":"DEVICE","name":"Artificial intelligence (AI) decision-support tool"}],"enrollment":400000,"startDate":"2025-10-15","completionDate":"2028-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"This trial will include all radiologists interpreting screening mammography and all adult patients undergoing screening mammography at any of the participating breast imaging facilities across 6 regional health systems (UCLA, UC San Diego, University of Washington-Seattle, University of Wisconsin-Madison, Boston Medical Center, and University of Miami) during the trial period. Individuals must meet the following eligiblity criteria.\n\nInclusion Criteria:\n\n1. Be at least 18 years of age or older\n2. Receive a screening mammogram at one of the participating breast imaging facilities OR be a radiologist who interprets screening mammograms at one of the participating breast imaging facilities.\n\nExclusion Criteria:\n\n1\\. Patients who have opted out of all research at the health system","locations":[{"facility":"University of California Los Angeles Health System","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Health System","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington Health System","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin-Madison","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle L'Hommedieu, PhD","phone":"(310) 592-9454","email":"mlhommedieu@mednet.ucla.edu"}],"primaryOutcomes":["Cancer detection rate","Recall rate"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-diego-california","miami-florida","boston-massachusetts","seattle-washington","madison-wisconsin"],"enrichment":{"headline":"Phase 4: Artificial intelligence (AI) decision-support tool for Breast Cancer Screening","inPlainEnglish":"The goal of this clinical trial is to compare patient-centered outcomes when screening digital breast tomosynthesis (DBT) exams are interpreted with versus without a leading FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S. settings and to assess patients' and radiologists' perspectives on AI in medicine.","whoItsFor":["Ages 18 Years to any","Be at least 18 years of age or older","Receive a screening mammogram at one of the participating breast imaging facilities OR be a radiologist who interprets screening mammograms at one of the participating breast imaging facilities"],"whoShouldSkip":["1\\. Patients who have opted out of all research at the health system"],"whatHappens":"If you join, the listed intervention(s) are Artificial intelligence (AI) decision-support tool. The registry lists allocation as randomized. The goal of this clinical trial is to compare patient-centered outcomes when screening digital breast tomosynthesis (DBT) exams are interpreted with versus without a leading FDA-cleared artificial intelligence (AI) decision-support tool in real-world U.S.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 400,000 people at 6 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.432Z"},{"nctId":"NCT06934252","title":"Phase 1a/1b Study of TRB-061 in Healthy Participants & Patients With Atopic Dermatitis","officialTitle":"A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled, 3-Part Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Subcutaneous Doses of TRB-061 in Healthy Participants and in Patients With Moderate-to-Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"TRex Bio, Inc.","sponsorClass":"INDUSTRY","summary":"This Phase 1a/1b randomized, double-blind, placebo-controlled study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).\n\nPart 1 (SAD): Healthy participants receiving single doses of TRB-061 or placebo.\n\nPart 2 (MAD): Healthy participants receiving multiple doses (3 doses over 8 weeks) of TRB-061 or placebo.\n\nPart 3 (Phase 1b): Participants with moderate-to-severe AD receiving repeated doses (4 doses over 12 weeks) of TRB-061 or placebo.","conditions":["Moderate-to-severe Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"TRB-061"},{"type":"DRUG","name":"TRB-061"},{"type":"DRUG","name":"TRB-061"},{"type":"DRUG","name":"Placebo"}],"enrollment":115,"startDate":"2025-05-02","completionDate":"2027-09-02","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged 18 to 70 years, inclusive, at the time of informed consent.\n2. Body weight ≥50 kg and a body mass index (BMI)between 18.5 and 35.0 kg/m², inclusive.\n3. Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests.\n4. For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening.\n5. For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening.\n6. Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing.\n7. Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only).\n8. For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit\n9. Agrees to abstain from the use of tetrahydrocannabinol (THC)-containing products while on study.\n\nExclusion Criteria:\n\n1. History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results.\n2. History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening.\n3. Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1.\n4. Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1.\n5. History of hypersensitivity or allergic reaction to any component of the study drug or placebo formulation.\n6. Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment.\n7. Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV).\n8. Active infection or history of serious infections within 4 weeks prior to Day 1.\n9. Clinically significant ECG abnormalities (e.g., QTcF\\>470 ms) or other cardiac risk factors.\n10. Abnormal and clinically significant laboratory values at screening.\n11. Use of live vaccines within 4 weeks before Day 1.\n12. Use of systemic corticosteroids, immunosuppressants, or immunomodulatory drugs within protocol-defined washout periods (Part 3 only).\n13. Recent history of alcohol or drug abuse as defined per protocol.\n14. Use of tobacco/nicotine products beyond protocol-allowed limits (SAD and MAD).\n15. Positive cotinine test at check-in (SAD/MAD only).\n16. Any other reason, in the opinion of the investigator or sponsor, that would make the participant unsuitable for participation in the study.\n17. Any medical or psychiatric condition that, in the opinion of the Investigator or Sponsor's medical monitor, would place the participant at risk, interfere with study participation, or interfere with the interpretation of study results.\n18. Surgery within the past 90 days prior to dosing as determined by the Investigator or Sponsor's medical monitor to be clinically relevant or planned surgery to be performed during the study and 30 days after the last dose of study drug","locations":[{"facility":"Paratus Clinical Research - Canberra Trial Clinic","city":"Deakin","state":"Australian Capital Territory","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Brisbane Pty Ltd","city":"Albion","state":"Brisbane","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Research Western Sydney","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Research Central Coast","city":"Kanwal","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cornerstone Centre for Clinical Research","city":"Coorparoo","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CMAX Clinical Research Pty Ltd","city":"Adelaide","state":"South Australia","country":"Australia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Research Melbourne","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alfred Health","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCR Sunshine","city":"Saint Albans","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research Pukekohe","city":"Pukekohe","state":"Auckland","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research Dunedin","city":"Dunedin","state":"Otago","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Research Network-Tasman","city":"Nelson","state":"Tasman District","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials New Zealand Ltd","city":"Hamilton","state":"Waikato Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Research Institute of New Zealand","city":"Newtown","state":"Wellington Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Research Network-Wellington","city":"Upper Hutt","state":"Wellington Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research Kapiti","city":"Waikanae","state":"Wellington Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Research Network-West Auckland","city":"Auckland","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCR Christchurch","city":"Christchurch","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCR Palmerston North","city":"Palmerston North","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"+1 (650) 567-5582","email":"clinicaltrials@trex.bio"}],"primaryOutcomes":["Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["deakin-australia","albion-australia","blacktown-australia","kanwal-australia","coorparoo-australia","adelaide-australia","melbourne-australia","saint-albans-australia","pukekohe-new-zealand","dunedin-new-zealand","nelson-new-zealand","hamilton-new-zealand","newtown-new-zealand","upper-hutt-new-zealand","waikanae-new-zealand","auckland-new-zealand","christchurch-new-zealand","palmerston-north-new-zealand"],"enrichment":{"headline":"Phase 1: testing TRB-061 for Moderate-to-severe Atopic Dermatitis","inPlainEnglish":"This Phase 1a/1b randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). The number of dosing cohorts may be increased or decreased in Part 1 (SAD) or Part 2 (MAD).","whoItsFor":["Ages 18 Years to 70 Years","Body weight ≥50 kg and a body mass index (body-mass index (BMI))between 18.5 and 35.0 kg/m², inclusive","Participant is in good general health as determined by the investigator, based on medical history, physical examination, and clinical laboratory tests","For healthy participants (SAD and MAD): no clinically significant abnormalities in ECGs at screening","For participants in Phase 1b: Confirmed diagnosis of AD with onset of symptoms at least 1 year prior to Screening","Must be nonpregnant and nonlactating with negative pregnancy tests at screening and prior to dosing","Must be a non-smoker or ≤5 cigarettes per week for the past 6 months (SAD/MAD only)","For participants in Phase 1b: Moderate-to-severe AD at Screening and at Day 1 visit"],"whoShouldSkip":["History of any clinically significant disease or disorder which, in the opinion of the investigator, may put the participant at risk or interfere with study results","History or presence of any condition requiring systemic immunosuppressive or immunomodulatory therapy within a defined period before screening","Use of any biologic agent (e.g., monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) before Day 1","Participation in another investigational drug trial within 30 days or 5 half-lives of the prior investigational product (whichever is longer) before Day 1","History of hypersensitivity or allergic reaction to any component of the study drug or dummy treatment (placebo) formulation","Known active or latent tuberculosis (TB) infection. or history of incomplete TB treatment","Positive test at screening for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or human immunodeficiency virus (HIV)"],"whatHappens":"If you join, the listed intervention(s) are TRB-061, TRB-061, or TRB-061. The registry lists allocation as randomized. This Phase 1a/1b randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluates the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of subcutaneously (SC) administered TRB-061 in healthy adults and patients with moderate-to-severe atopic dermatitis (AD).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 115 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.831Z"},{"nctId":"NCT06934525","title":"Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.","officialTitle":"Testing Delivery Modalities of Team-Based Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety in Community Health Settings: Developing Pathways to Health Equity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Bradley Hospital","sponsorClass":"OTHER","summary":"The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., social worker) who also provides weekly supervision for the exposure coach. This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.\n\nTreatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.\n\nThe research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.","conditions":["Obsessive Compulsive Disorder (OCD)","Pediatric Anxiety Disorders","Anxiety Disorder","Anxiety","OCD","Phobia","Agoraphobia","Generalized Anxiety","Generalized Anxiety Disorder","Selective Mutism","Separation Anxiety","Social Anxiety","Social Anxiety Disorder","Panic Disorder","Pediatric Disorders"],"keywords":["exposure therapy","cognitive behavioral therapy","anxiety treatment","exposure and response prevention therapy","ERP","pediatric anxiety treatment"],"interventions":[{"type":"BEHAVIORAL","name":"Team-delivered, exposure-based CBT"}],"enrollment":501,"startDate":"2025-11-01","completionDate":"2029-02-01","sex":"ALL","minAge":"5 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 5-18 inclusive\n* Primary or co-primary DSM-V diagnosis of anxiety or OCD\n* Symptom duration of at least 3 months\n* Outpatient care needed\n* Presence of a stable parent, or guardian, who can participate in treatment\n\nExclusion Criteria:\n\n* Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment\n* Acute suicidality\n* Concurrent psychotherapy\n* Chronic medical illness that would preclude their active participation in treatment\n* Treatment with psychotropic medication that is not stable","locations":[{"facility":"Bradley Hospital","city":"East Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Freeman, PhD","phone":"401-432-1000","email":"jfreeman@brownhealth.org"}],"primaryOutcomes":["Top Problems Assessment- Caregiver report","Child Sheehan Disability Scale (CSDS)- caregiver report"],"hasResults":false,"conditionSlugs":["als","anxiety"],"drugSlugs":[],"locationSlugs":["east-providence-rhode-island"],"enrichment":{"headline":"Not a traditional drug phase: Team-delivered, exposure-based CBT for Obsessive Compulsive Disorder (OCD)","inPlainEnglish":"This study wants to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations.","whoItsFor":["Ages 5 Years to 18 Years","Primary or co-primary DSM-V diagnosis of anxiety or OCD","Symptom duration of at least 3 months","Outpatient care needed","Presence of a stable parent, or guardian, who can participate in treatment"],"whoShouldSkip":["Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment","Concurrent psychotherapy","Chronic medical illness that would preclude their active participation in treatment","Treatment with psychotropic medication that is not stable"],"whatHappens":"If you join, the listed intervention(s) are Team-delivered, exposure-based CBT. The registry lists allocation as randomized. This study wants to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 501 people at East Providence. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.358Z"},{"nctId":"NCT06934681","title":"Exercise to Fight Obesity","officialTitle":"Impact of a Structured Physical Exercise Program on Body Composition in Morbid Obesity: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Instituto de Investigacion Sanitaria La Fe","sponsorClass":"OTHER","summary":"This clinical trial aims to determinate whether a structured exercise program, supported by telerehabilitation, can help individuals with severe obesity who are going to undergo bariatric surgery.\n\nThe main objective of this study is whether a structured exercise program, including both supervised and home-based workouts, leads to greater body fat loss and improved strength compared to usual care. Furthermore, it also aims to evaluate other potentially affected aspects, such as body composition and functionality, quality of life, cardiovascular fitness, and various genetic and metabolic factors.\n\nThis study is a randomized clinical trial with two groups:\n\n* The intervention group will follow a structured exercise program both pre- and post- surgery.\n* The control group will receive standard care, including nutritional counseling and general health advice.\n\nThe study will include 72 adults with severe obesity (36 men and 36 women), all of whom will be randomly assigned to either the intervention or control group.\n\nParticipants in the exercise group will follow these steps:\n\n1. Before Surgery (Prehabilitation): A 26-week program with aerobic and strength exercises, done in-person or remotely 2-4 times per week.\n2. Pre-Surgery Maintenance: A flexible period before surgery where participants continue exercising on their own.\n3. After Surgery (Rehabilitation): A 20-week program focused on recovery and strength.\n4. Post-Surgery Maintenance: A long-term, self-guided phase to maintain progress.\n\nParticipants in the exercise group will also receive the same care as the control group, including nutrition counseling and medical checkups.\n\nTo evaluate participant progress, a series of measurements will be carried out, including:\n\n* BMI and body composition\n* Physical function assessed through isometric strength tests and other measures such as the Sit-to-Stand test and the 6-Minute Walk Test\n* Quality of life and lifestyle assessed using validated questionnaires\n* Daily physical activity measured with pedometers\n* Metabolic and genetic analysis from blood samples\n\nIf proven effective, this program could help establish structured exercise with telerehabilitation as a standard component of obesity care. The results may support the integration of exercise programs into clinical practice, leading to improved long-term outcomes for individuals with severe obesity undergoing bariatric surgery. Additionally, insights into genetic and metabolic factors may contribute to the development of personalized treatment strategies.","conditions":["Morbid Obesity","Bariatric Surgery","Telerehabilitation"],"keywords":["Bariatric surgery","Physical Exercise","Telerehabilitation","Prehabilitation","Rehabilitation","Body composition","Morbid obesity","Functional capacity"],"interventions":[{"type":"BEHAVIORAL","name":"Usual Care Group"},{"type":"BEHAVIORAL","name":"Controlled exercise with telerehabilitation"}],"enrollment":72,"startDate":"2025-05-19","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age: 18-65 years\n* BMI ≥35 with comorbidities, or ≥40, regardless of comorbidity presence\n\nExclusion Criteria:\n\n* Participation in a structured physical exercise program within the past 6 months\n* Presence of musculoskeletal or systemic diseases that prevent participation in a physical exercise program\n* Uncontrolled hypertension\n* Uncontrolled diabetes, particularly in the presence of severe complications (neuropathy and/or diabetic foot, proliferative retinopathy)\n* Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)","locations":[{"facility":"Facultad de Fisioterapia, universidad de Valencia","city":"Valencia","state":"Valencia","country":"Spain","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hospital La Fe","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paolo Rossetti, Medicine","phone":"+34608109913","email":"rossetti_paolo@gva.es"},{"name":"Pilar Masdeu, Medicine","phone":"+34645741579","email":"pilarmasdeu97@gmail.com"}],"primaryOutcomes":["Fat mass percentage","Lower limb strength"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":[],"locationSlugs":["valencia-spain"],"enrichment":{"headline":"Not a traditional drug phase: Usual Care Group for Morbid Obesity","inPlainEnglish":"This clinical trial aims to determinate whether a structured exercise program, supported by telerehabilitation, can help individuals with severe obesity who are going to undergo bariatric surgery. The main objective of this study is whether a structured exercise program, including both supervised and home-based workouts, leads to greater body fat loss and improved strength compared to usual care.","whoItsFor":["Ages 18 Years to 65 Years","body-mass index (BMI) ≥35 with comorbidities, or ≥40, regardless of comorbidity presence"],"whoShouldSkip":["Participation in a structured physical exercise program within the past 6 months","Presence of musculoskeletal or systemic diseases that prevent participation in a physical exercise program","Uncontrolled hypertension","Uncontrolled diabetes, particularly in the presence of severe complications (neuropathy and/or diabetic foot, proliferative retinopathy)","Uncontrolled or unstable cardiovascular disease (acute myocardial infarction within the past year, angina, heart failure, peripheral artery disease)"],"whatHappens":"If you join, the listed intervention(s) are Usual Care Group, or Controlled exercise with telerehabilitation. The registry lists allocation as randomized. This clinical trial aims to determinate whether a structured exercise program, supported by telerehabilitation, can help individuals with severe obesity who are going to undergo bariatric surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.823Z"},{"nctId":"NCT06935370","title":"A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart","officialTitle":"EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) < 40%","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure.\n\nIn this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.","conditions":["Heart Failure"],"keywords":[],"interventions":[{"type":"DRUG","name":"vicadrostat"},{"type":"DRUG","name":"empagliflozin"},{"type":"DRUG","name":"Placebo"}],"enrollment":4200,"startDate":"2025-05-20","completionDate":"2029-02-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol.\n4. Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) \\< 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)).\n5. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory\n6. Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local/international guidelines and judgement of the investigator.\n\nAdditional inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment.\n2. Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.\n3. Receiving the following treatments:\n\n   * A direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation\n     * i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG)\n5. Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply.","locations":[{"facility":"Cure Clinical Research","city":"Beverly Hills","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Valley Clinical Trials, Inc.","city":"Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Coast Cardiology","city":"Encinitas","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Merced Vein and Vascular Center","city":"Merced","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radin Cardiovascular Medical Group","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amicis Research Center - Nordhoff","city":"Northridge","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research - 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People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study.","whoItsFor":["Ages 18 Years to any","At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years","Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory","Additional who can join apply"],"whoShouldSkip":["Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator","Receiving the following treatments:","A direct renin inhibitor (e.g. aliskiren) at Visit 2","More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2","Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial","Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2","In case of acute decompensated HF:"],"whatHappens":"If you join, the listed intervention(s) are vicadrostat, empagliflozin, or Placebo. 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Overweight"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mirikizumab"},{"type":"DRUG","name":"Mirikizumab"},{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":350,"startDate":"2025-06-26","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.\n* Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.\n* Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.\n* Have obesity, \\[body mass index (BMI) 30 kilograms per meter squared (kg/m2)\\]\n* Have overweight (BMI ≥27 kg/m2 to \\<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 Diabetes Mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or 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3: testing Mirikizumab for Ulcerative Colitis","inPlainEnglish":"The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and dummy treatment (placebo), leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight. Participation in this study will last up to 61 weeks, including 52 weeks of treatment.","whoItsFor":["Ages 18 Years to 70 Years","Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC","Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline","Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer","Have obesity, \\[body mass index (body-mass index (BMI)) 30 kilograms per meter squared (kg/m2)\\]","Have overweight (body-mass index (BMI) ≥27 kg/m2 to \\<30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:","Type 2 Diabetes Mellitus (T2DM)","obstructive sleep apnea, or"],"whoShouldSkip":["Have a current diagnosis of:","inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or","primary sclerosing cholangitis","Have had or will need bowel resection or intestinal or intra-abdominal surgery","Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope","Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM","Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Mirikizumab, Mirikizumab, or Tirzepatide. The registry lists allocation as randomized. The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and dummy treatment (placebo), leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 350 people at 185 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.205Z"},{"nctId":"NCT06937099","title":"Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","officialTitle":"A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.\n\nThe maximum duration of this study is up to 61 weeks.","conditions":["Crohn's Disease","Obesity or Overweight"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mirikizumab"},{"type":"DRUG","name":"Mirikizumab"},{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":290,"startDate":"2025-06-26","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD\n* Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m²), or overweight (BMI ≥27 kg/m2 to \\<30 kg/m²) and in the presence of at least 1 weight-related comorbid conditions:\n\n  * hypertension\n  * Type 2 diabetes mellitus (T2DM)\n  * dyslipidemia\n  * obstructive sleep apnea, or\n  * cardiovascular disease.\n* Have moderately to severely active CD defined by a CDAI score of at least 220 at baseline.\n* Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.\n* Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.\n* Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy\n\nExclusion Criteria:\n\n* Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.\n* Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.\n* Currently have or are suspected to have an abscess.\n* Have a stoma, ileoanal pouch, or ostomy.\n* Have a history of more than 3 small bowel resections, total resection of small bowel greater than 100 centimeters (cm), diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.\n* Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.\n* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.\n* Have had more than 5% body weight change in the past 3 months\n* Have a current or recent acute, active infection.","locations":[{"facility":"Digestive Health Specialists","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smart Cures Clinical Research","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"United Medical Doctors - 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The registry lists allocation as randomized. The main purpose of this study is to measure the how well it works and safety of mirikizumab and dummy treatment (placebo) compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 290 people at 182 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.892Z"},{"nctId":"NCT06941376","title":"Pragmatic, Open-Label Study to Pilot Evaluation for Clinical Trials in Relapsing Polychondritis","officialTitle":"Pragmatic, Open-Label, Two-Stage, Pilot Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"Open label pragmatic two-stage non-randomized trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).","conditions":["Relapsing Polychondritis"],"keywords":["Relapsing Polychondritis","RP","Vasculitis","Polychondritis, relapsing"],"interventions":[{"type":"DRUG","name":"Methotrexate (MTX)"},{"type":"DRUG","name":"Azathioprine (AZA)"},{"type":"BIOLOGICAL","name":"Adalimumab"},{"type":"BIOLOGICAL","name":"Infliximab"},{"type":"BIOLOGICAL","name":"Tocilizumab"}],"enrollment":20,"startDate":"2025-11-11","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nA. ≥18 years of age\n\nB. Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis McAdam's Criteria (1976)\n\n≥ 3 criteria out of 6 of the following:\n\n1. Bilateral auricular chondritis\n2. Non-erosive seronegative polyarthritis\n3. Nasal chondritis\n4. Ocular inflammation\n5. Respiratory tract chondritis\n6. Cochlear and/or vestibular dysfunction\n\nDamiani's Criteria (1979)\n\n1. ≥3 of McAdam's Criteria as above\n2. ≥1 of McAdam's Criteria with histological confirmation of chondritis\n3. ≥2 of McAdam's Criteria with positive response to glucocorticoids or dapsone\n\nMichet's Criteria (1986)\n\nPresence of ≥2 of the following criteria:\n\n1. Auricular chondritis\n2. Nasal chondritis\n3. Laryngotracheal chondritis\n\nOr presence of ≥1 of the above criteria and ≥2 of the following criteria\n\n1. Seronegative inflammatory arthritis\n2. Ocular inflammation\n3. Hearing loss\n4. Vestibular dysfunction\n\nC. Mild to moderately active disease within 60 days prior to screening where the symptoms cannot be attributed to any cause other than RP and which, in the investigator's opinion, requires addition/ increase in prednisone dose between 15-60 mg/ day.\n\nAt the time of enrollment and during the trial, the following symptoms of active disease which will be evaluated:\n\n1. Auricular inflammation: defined as increase/ new onset pain/ swelling/redness of external ear(s), ear canal\n2. Nasal inflammation: defined as increase/ new onset pain/ swelling/redness of external nose\n3. Ocular inflammation: defined as new onset/ worsening unilateral/ bilateral episcleritis/scleritis/ uveitis.\n4. Inflammatory arthritis: defined as new onset/ worsening morning stiffness≥30 minutes, physician diagnosed tenderness/swelling in ≥1 joint; new onset/ worsening costochondritis.\n5. Mild to moderate airway inflammation: defined as new onset/ worsening mild to moderate inflammation of upper airway diagnosed by direct laryngoscopy and attributed to RP; abnormal CT airway/ bronchoscopy showing wall thickening of airway (larynx, trachea, bronchi) and absence of severe manifestations such as new onset SGS/tracheomalacia/ bronchomalacia.\n6. Sinonasal disease: defined as new onset/ increase in nasal crusting, discharge bleeding\n7. Constitutional symptoms: defined as new onset/ worsening fever, unintentional weight loss of ≥ 5% of body weight, night sweats Patients must have at least 1 of the first 5 criteria within the past 60 days prior to the enrollment.\n\nD. Willing and able to comply with treatment and follow-up procedures.\n\nE. Both men and women of childbearing potential must be willing to use an effective means of birth control while receiving treatment throughout the study. Effective contraception methods include abstinence, oral contraceptives (birth control pills), intra-uterine-device, diaphragm, approved hormone injections, condoms, or medical sterilization.\n\nF. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\nA. Severe disease manifestations within the past 14 days requiring hospitalization, and/or intravenous pulsed dose glucocorticoid treatment for disease control.\n\nB. Prior exposure of 4 weeks or longer to adalimumab, infliximab, and/or tocilizumab.\n\nC. Prior exposure to \\>2 biologics and/or JAKi.\n\nD. Evidence of active infection.\n\nE. Known infection with human immunodeficiency virus (HIV), untreated hepatitis C infection, or a positive hepatitis B virus surface antigen.\n\nF. Patients at risk for tuberculosis (TB) defined as follows:\n\n1. Current clinical, radiographic or laboratory evidence of active TB, even if currently being treated. Chest x-rays (posterior/anterior and lateral) obtained within the 6 months prior to screening and TB testing (IFN gamma release assay or PPD) performed in the past month prior to screening will be accepted; however, a copy of the reports must be placed in the participant binder.\n2. A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines.\n3. Patients with a positive TB screening test indicative of latent TB will not be eligible for the study unless they: i. Have no evidence of current TB based on chest x-ray performed during the screening period and by history and physical exam, and ii. They are currently being treated for latent TB or the site has documentation of successful prior treatment of latent TB. Treatment regimens should be dictated by local guidelines as long as the treatment dose and duration meet or exceed local health authority guidelines. Patients with latent TB may be eligible for the trial prior to completion of treatment as long as they have completed at least 4 weeks of treatment and they have no evidence of current TB on chest x-ray at screening.\n\nG. Inability to comply with study guidelines.\n\nH. Cytopenia: platelet count \\<80,000/mm3, absolute neutrophil count \\<1500/mm3, hematocrit \\< 20%.\n\nI. Other uncontrolled disease (co-morbidity) that could prevent a subject from fulfilling the study requirements or that would increase the risk of study procedures.\n\nJ. Patients who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Patients who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n\nK. Receipt of an investigational agent or device within 30 days prior to enrollment\n\nL. A live vaccination \\< 4 weeks before enrollment\n\nM. Presence of any of the following diseases:\n\n1. ANCA-associated vasculitis\n2. Polyarteritis nodosa\n3. Giant cell arteritis\n4. Takayasu's arteritis\n5. Cogan's syndrome\n6. Tuberculosis or atypical mycobacterial infections\n7. Deep fungal infections\n8. Lymphoma, lymphomatoid granulomatosis, or other type of malignancy that mimics vasculitis\n9. Overlap with other systemic autoimmune diseases which would impair assessment of response\n10. Diagnosis of VEXAS syndrome","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol McAlear","phone":"781-321-4567","email":"cmcalear@upenn.edu"}],"primaryOutcomes":["Efficacy of the study drugs for the treatment of relapsing polychondritis."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["adalimumab"],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Phase 2: testing Methotrexate (MTX) for Relapsing Polychondritis","inPlainEnglish":"Open label pragmatic two-stage non-randomly assigned trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).","whoItsFor":["Ages 18 Years to any","A. ≥18 years of age","B. Must fulfill McAdam's or Damiani's or Michet's Criteria Diagnostic Criteria for Relapsing Polychondritis McAdam's Criteria (1976)","≥ 3 criteria out of 6 of the following:","Bilateral auricular chondritis","Non-erosive seronegative polyarthritis","Ocular inflammation","Respiratory tract chondritis"],"whoShouldSkip":["A. Severe disease manifestations within the past 14 days requiring hospitalization, and/or intravenous pulsed dose glucocorticoid treatment for disease control","B. Prior exposure of 4 weeks or longer to adalimumab, infliximab, and/or tocilizumab","C. Prior exposure to \\>2 biologics and/or JAKi","D. Evidence of active infection","E. Known infection with human immunodeficiency virus (HIV), untreated hepatitis C infection, or a positive hepatitis B virus surface antigen","F. Patients at risk for tuberculosis (TB) defined as follows:","A history of active TB unless there is documentation that the patient had received prior anti-TB treatment that was appropriate in duration and type according to local health authority guidelines"],"whatHappens":"If you join, the listed intervention(s) are Methotrexate (MTX), Azathioprine (AZA), or Adalimumab. The registry lists allocation as randomized. Open label pragmatic two-stage non-randomly assigned trial comparing the effectiveness of five different standard of care treatment options for patients with relapsing polychondritis (RP).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.267Z"},{"nctId":"NCT06941870","title":"Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy","officialTitle":"Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients With Hemophilia A","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A.\n\nThe study duration for each participant is approximately 12 months.","conditions":["Factor VIII Deficiency"],"keywords":[],"interventions":[{"type":"DRUG","name":"Efanesoctocog alfa"}],"enrollment":35,"startDate":"2025-09-23","completionDate":"2027-10-25","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent/assent.\n* Participant is more than or equal to (≥)12 years old at the time of consent/assent.\n* Participant has existing synovial hypertrophy, defined as at least 1 eligible\\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent/assent.\n* Participant has at least 1 eligible\\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1).\n\n  \\*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis\n* Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2).\n* Participant is capable of understanding the written Informed Consent Form (ICF)/assent form, provides a signed and witnessed written ICF/assent form, and agrees to comply with the protocol requirements.\n* If male, no contraceptive measures are required for this study.\n* If female, is not pregnant or breastfeeding, and one of the following conditions applies:\n* Is a women of nonchildbearing potential (WONCBP)\n* Is a WOCBP and agrees to use a highly effective contraceptive method, with a failure rate of less than (\\<)1 percent during the study treatment period (at least until the Week 52/ End of Treatment \\[EoT\\] visit).\n* A WOCBP must have a negative serum pregnancy test at the screening visit (Visit 1)\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n* Has other associated clotting disorders at the time of consent/assent.\n* Is already under efanesoctocog alfa treatment.\n* Has a current diagnosis of an factor VIII (FVIII) inhibitor, defined as inhibitor titer ≥0.60 BU/mL.\n* Has ITI within the last 2 years prior to the baseline visit (Visit 2).\n* Has been enrolled in a concurrent clinical interventional study or exposed to other investigational drug(s) within 3 months prior to screening for this study.\n* Is currently in an institution because of regulatory or legal order (that is, is a prisoner or a patient who is legally institutionalized).\n* Is not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.\n* Is an employee or family member of the investigator or site personnel.\n* Is involved in a specific situation during study implementation or the course of the study that may raise ethics considerations.\n* Has hypersensitivity to efanesoctocog alfa or its components or any of its excipients that, in the opinion of the investigator, contraindicates participation in the study.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Orthopedic Institute for Children- Site Number : 8400009","city":"Los Angeles","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of California Davis Medical Center-Site Number: 8400005","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana Hemophilia and Thrombosis Center- Site Number : 8400006","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa- Site Number : 8400004","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Wexner Medical Center - CarePoint East- Site Number : 8400001","city":"Columbus","state":"Ohio","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Oregon Health and Science University-Site Number: 8400002","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Center for Bleeding Disorders- Site Number : 8400008","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360001","city":"Murdoch","state":"Western Australia","country":"Australia","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240002","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240001","city":"St. John's","state":"Newfoundland and Labrador","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240003","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240004","city":"Hamilton","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920003","city":"Kawasaki","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920002","city":"Hiroshima","state":"","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920001","city":"Saitama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3920004","city":"Tokyo","state":"","country":"Japan","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 1580003","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1580001","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1580002","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Proportion of joints with improvement in the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) synovitis domain score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","sacramento-california","indianapolis-indiana","iowa-city-iowa","columbus-ohio","portland-oregon","seattle-washington","murdoch-australia","calgary-canada","st-johns-canada","hamilton-canada","kawasaki-japan","hiroshima-japan","saitama-japan","tokyo-japan","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 4: testing Efanesoctocog alfa for Factor VIII Deficiency","inPlainEnglish":"The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A. The study duration for each participant is approximately 12 months.","whoItsFor":["Ages 12 Years to any","Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent/assent","Participant is more than or equal to (≥)12 years old at the time of consent/assent","Participant has existing synovial hypertrophy, defined as at least 1 eligible\\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent/assent","Participant has at least 1 eligible\\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1)","\\*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis","Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2)","If male, no contraceptive measures are required for this study"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Has other associated clotting disorders at the time of consent/assent","Is already under efanesoctocog alfa treatment","Has a current diagnosis of an factor VIII (FVIII) inhibitor, defined as inhibitor titer ≥0.60 BU/mL","Has ITI within the last 2 years prior to the baseline visit (Visit 2)","Has been enrolled in a concurrent clinical treatment study or exposed to other investigational drug(s) within 3 months prior to screening for this study","Is currently in an institution because of regulatory or legal order (that is, is a prisoner or a patient who is legally institutionalized)"],"whatHappens":"If you join, the listed intervention(s) are Efanesoctocog alfa. The registry lists allocation as randomized. The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 35 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.188Z"},{"nctId":"NCT06943001","title":"Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents","officialTitle":"Adapting and Assessing the Feasibility of a Telehealth Diabetes Prevention Program for Hispanic Adolescents","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Baylor College of Medicine","sponsorClass":"OTHER","summary":"Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents. Telehealth is a potentially effective approach for delivering disease prevention programs as it addresses some SDoH like transportation, childcare needs, and parent work schedules. Unfortunately, there are no theory- or evidence-based telehealth diabetes prevention program for Hispanic adolescents. Therefore the purpose of this study is to adapt an evidence-based diabetes prevention program for delivery via telehealth and to test the feasibility of this study among Hispanic adolescents (12-16 years) with obesity.","conditions":["Obesity and Type 2 Diabetes"],"keywords":["adolescents health","wearable sensors","user-centered design approac","T2D prevention"],"interventions":[{"type":"BEHAVIORAL","name":"Fit24+"}],"enrollment":40,"startDate":"2025-04-12","completionDate":"2026-08-31","sex":"ALL","minAge":"14 Years","maxAge":"16 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Self-report as Hispanic\n* obese, defined as body mass index percentile (BMI%) ≥ 95th percentile\n* ages of 12-16 years\n* owns his or her own cellphone\n\nExclusion Criteria:\n\n* Taking a medication (i.e. steroids) or diagnosed with a condition (i.e. sleep apnea) that influences activity, sleep, and/or cognition\n* Recent hospitalization or injury that prevents normal physical activity\n* Pregnant\n* Currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit\n* Taking medications or diagnosed with a condition that influences activity, glucose metabolism, and/or cognition.","locations":[{"facility":"USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erica Soltero, PhD","phone":"402-910-0832","email":"soltero@bcm.edu"}],"primaryOutcomes":["Feasibility"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Fit24+ for Obesity and Type 2 Diabetes","inPlainEnglish":"Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D). Social determinants of health (SDoH) serve as barriers to behavior change and participation in disease prevention efforts, especially among vulnerable adolescents.","whoItsFor":["Ages 14 Years to 16 Years","Self-report as Hispanic","obese, defined as body mass index percentile (body-mass index (BMI)%) ≥ 95th percentile","ages of 12-16 years","owns his or her own cellphone"],"whoShouldSkip":["Taking a medication (i.e. steroids) or diagnosed with a condition (i.e. sleep apnea) that influences activity, sleep, and/or cognition","Recent hospitalization or injury that prevents normal physical activity","Currently enrolled in an exercise program or currently using a personal activity monitoring device like Fitbit","Taking medications or diagnosed with a condition that influences activity, glucose metabolism, and/or cognition"],"whatHappens":"If you join, the listed intervention(s) are Fit24+. The registry lists allocation as randomized. Hispanic adolescents are disproportionately burdened by type 2 diabetes (T2D).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Houston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.520Z"},{"nctId":"NCT06943573","title":"Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder","officialTitle":"Psilocybin-Assisted Therapy for Treatment-Resistant Depression in Bipolar II Disorder: A Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Lakshmi N Yatham","sponsorClass":"OTHER","summary":"This study is a 12-week (in addition to up to 30 days of screening) randomized, double-blind, placebo-controlled, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active placebo (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). The active placebo is a substance that looks identical to the study medication but contains less therapeutic ingredients, and thus is less capable of producing the transformative and meaningful aspects of psychedelic experience compared to the 25 mg dose. Participants will have a total of 11 study visits over a period of up to 16 weeks, which includes 5 therapy sessions from trained study therapists.","conditions":["Bipolar II Depression"],"keywords":["Bipolar Disorder","Mood Disorder","Psychedelic-assisted therapy","Psychedelics","Treatment resistant","Psilocybin","Depression"],"interventions":[{"type":"DRUG","name":"psilocybin (25 mg)"},{"type":"DRUG","name":"psilocybin 1mg micro-dose"}],"enrollment":90,"startDate":"2026-06-15","completionDate":"2028-12","sex":"ALL","minAge":"19 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. You are male or female aged 19 to 65 years inclusive.\n2. You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode.\n3. You are willing, for the entire duration of the study, to practice highly effective methods of contraception (e.g., contraceptive pills, intrauterine device or system, vasectomy and tubal ligation, or double-barrier methods of contraception) OR agree to completely abstain from heterosexual intercourse. Females who do not have childbearing potential are required to be postmenopausal for at least 1 year before the screening visit (confirmed by an FSH test) OR surgically sterile.\n4. You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations.\n5. Your current medications have been at a stable dose for two weeks prior to the dosing visit.\n\nExclusion Criteria:\n\n1. You have a history of psychotic symptoms.\n2. You have a history of seizures.\n3. You have a first-degree relative, such as your parent, sibling, or child, with a diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder, schizophrenia).\n4. You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression.\n5. You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode.\n6. You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).\n7. You have a history of nonresponse or intolerance to psilocybin.\n8. You have, in the past 6 months, used any psychedelic drugs, including ketamine, LSD, or psilocybin-containing mushrooms.\n9. You have a history of non-response to electroconvulsive therapy.\n10. You are pregnant or lactating.","locations":[{"facility":"Djavad Mowafaghian Centre for Brain Health","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Psychiatry, University of Ottawa, The Ottawa Hospital","city":"Ottawa","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Department of Psychiatry, University of Toronto, University Health Network,","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vy Ngo, B.Sc","phone":"604-822-3769","email":"vy.ngo@ubc.ca"},{"name":"Nazlin Walji, B.Sc, CCRC","phone":"604-822-7294","email":"nazlin.walji@ubc.ca"}],"primaryOutcomes":["Change in depressive symptoms"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":["psilocybin"],"locationSlugs":["vancouver-canada","ottawa-canada","toronto-canada"],"enrichment":{"headline":"Phase 2: testing psilocybin (25 mg) for Bipolar II Depression","inPlainEnglish":"This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial. The primary objective of this study is to assess the effectiveness, safety, and tolerability of single-dose psilocybin (25 mg)-assisted therapy in comparison to active dummy treatment (placebo) (1 mg micro-dose) psilocybin-assisted therapy in patients with bipolar II depression who have not responded to adequate trials with at least two first or second-line treatments for bipolar II depression (i.e.","whoItsFor":["Ages 19 Years to 65 Years","You are male or female aged 19 to 65 years inclusive","You have a diagnosis of bipolar disorder type II, and are currently in a major depressive episode","You have sufficient English language skills to understand, consent to, and comply with study requirements, study visits, and to return to the clinic for follow-up evaluations","Your current medications have been at a stable dose for two weeks prior to the dosing visit"],"whoShouldSkip":["You have a history of psychotic symptoms","You have a history of seizures","You have a first-degree relative, such as your parent, sibling, or child, with a diagnosis of a primary psychotic disorder (e.g., schizoaffective disorder, schizophrenia)","You have a current unstable or inadequately treated medical illness, especially cardiovascular illness, except for the current depression","You recently (i.e., within the past 6 weeks) started taking treatment for your acute bipolar depressive episode","You recently (i.e., within the past 8 weeks) began structured psychotherapy (e.g., cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy)","You have a history of nonresponse or intolerance to psilocybin"],"whatHappens":"If you join, the listed intervention(s) are psilocybin (25 mg), or psilocybin 1mg micro-dose. The registry lists allocation as randomized. This study is a 12-week (in addition to up to 30 days of screening) randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.103Z"},{"nctId":"NCT06944522","title":"A Study to Investigate the Efficacy and Safety of Bemdaneprocel in Adults Who Have Parkinson's Disease","officialTitle":"exPDite-2: A Phase 3 Study to Assess the Efficacy and Safety of Midbrain Dopaminergic Neuronal Cell Therapy (Bemdaneprocel) for Participants With Parkinson's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"BlueRock Therapeutics","sponsorClass":"INDUSTRY","summary":"Study BRT-DA01-301 is a Phase 3 multicenter, randomized, sham surgery-controlled, double-blind study to assess efficacy and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).","conditions":["Parkinsons Disease (PD)"],"keywords":["exPDite-2","Cell Therapy","Cellular Therapy","Dopaminergic Neuronal Cell Therapy","Parkinsons Disease"],"interventions":[{"type":"BIOLOGICAL","name":"bemdaneprocel"},{"type":"PROCEDURE","name":"Sham surgery"}],"enrollment":102,"startDate":"2025-06-17","completionDate":"2028-10","sex":"ALL","minAge":"45 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society\n* Individual of any sex ≥45 to ≤75 years of age at informed consent\n* Robust and clear response to DA therapy as defined by MDS-UPDRS Part III\n* ≥4 and \\<12 years from time of PD diagnosis at informed consent\n* Must demonstrate responsiveness to levodopa therapy\n* Receiving medical therapy for the treatment of PD symptoms\n* ≥2.5 hours of daily OFF-time\n* Vaccinated per current national guidelines or local practice for patients with altered immunocompetence\n\nExclusion Criteria:\n\n* PD presenting with recurrent falls\n* Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia\n* Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment\n* History of gene therapy or cell therapy for a neurological or intercerebral condition\n* Prior treatment with intrajejunal or subcutaneous infusion therapies for PD\n* Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery\n* Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI\n* Any history or evidence of infection with HBV or HIV; any active infection with HCV, CMV, syphilis, or latent tuberculosis; and any condition that, in the opinion of the investigator could put the participant at significant risk from immunosuppression or impact the participant's ability to perform study assessments. Exceptions: Treated and resolved TB, syphilis and/or HCV are not exclusionary\n* Current or previously active malignant disease within the past 5 years\n* Chronic immunosuppressive therapy\n* Receipt of another investigational therapy within 5 half-lives of the active treatment\n* Pregnancy or breastfeeding\n* Unable to comply with study requirements for any reason","locations":[{"facility":"Mayo Clinic Scottsdale - Neurology","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner Sun Health Research Institute","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA NeuroTranslational Research Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCI Medical Center - Neurology","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Neuroscience Health Center","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Hospital - Neurology Clinic","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Georgetown University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Jacksonville - Neurology","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Health System - Neurology","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USF Parkinson's Disease and Movement Disorders Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkinson's Disease and Movement Disorders Center at Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center - Neurology","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville Hospital","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital - Neurology","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center - Neurology","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Clinical Research Unit - Neurology","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Clinical Research Unit - Neurology","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quest Research Institute","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UBMD Neurology","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai West - Neurology","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Presbyterian/Weill Cornell Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Neurological Disorders Clinic","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Toledo Medical Center","city":"Toledo","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OHSU Neurology Clinic, South Waterfront","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rhode Island Hospital - Neurology","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina, Movement Disorders Dept.","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Houston Neurosciences - Texas Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Vermont Medical Center","city":"Burlington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"EvergreenHealth - Research Department","city":"Kirkland","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuRA (Neuroscience Research Australia)","city":"Randwick","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gold Coast Hospital & Health Service","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Medical Centre","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred Hospital","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Melbourne Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network - Toronto Western Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHUM - Centre hospitalier de l'Université de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patient Engagement","phone":"1-877-380-3967","email":"clinicaltrials@bluerocktx.com"}],"primaryOutcomes":["Change from baseline in PD diary measure of ON-time without troublesome dyskinesia, adjusted for a 16-hour waking day"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","sun-city-arizona","little-rock-arkansas","los-angeles-california","orange-california","palo-alto-california","aurora-colorado","washington-d-c-district-of-columbia","jacksonville-florida","miami-florida","tampa-florida","chicago-illinois","kansas-city-kansas","louisville-kentucky","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","farmington-hills-michigan","buffalo-new-york","new-york-new-york","durham-north-carolina","toledo-ohio","portland-oregon","providence-rhode-island","charleston-south-carolina","nashville-tennessee","houston-texas","burlington-vermont","richmond-virginia","kirkland-washington","randwick-australia","southport-australia","woolloongabba-australia","clayton-australia","melbourne-australia","parkville-australia","vancouver-canada","toronto-canada","montreal-canada"],"enrichment":{"headline":"Phase 3: testing bemdaneprocel for Parkinsons Disease (PD)","inPlainEnglish":"Study BRT-DA01-301 is a Phase 3 multicenter, randomly assigned, sham surgery-controlled, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).","whoItsFor":["Ages 45 Years to 75 Years","Diagnosis of clinically established PD as defined by the International Parkinson and Movement Disorders Society","Robust and clear response to DA therapy as defined by MDS-UPDRS Part III","Must demonstrate responsiveness to levodopa therapy","Receiving medical therapy for the treatment of PD symptoms","≥2.5 hours of daily OFF-time","Vaccinated per current national guidelines or local practice for patients with altered immunocompetence"],"whoShouldSkip":["PD presenting with recurrent falls","Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, or clinical features suggestive of a neurodegenerative disease other than PD, including multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, or Lewy body dementia","Any current or relevant previous history of serious, severe, or unstable physical, neurological, or psychiatric illness that may interfere with study participation, participant's safety, or assessment of endpoints per investigator's judgment","History of gene therapy or cell therapy for a neurological or intercerebral condition","Prior treatment with intrajejunal or subcutaneous infusion therapies for PD","Prior surgical or radiation therapy to the brain, including deep brain stimulation (DBS) and lesion therapy, or prior history of intradural spinal cord surgery","Contraindication to surgery, general anesthesia, cell therapy, immunosuppression, or other required drugs, or anything that prevents use of PET or MRI"],"whatHappens":"If you join, the listed intervention(s) are bemdaneprocel, or Sham surgery. The registry lists allocation as randomized. Study BRT-DA01-301 is a Phase 3 multicenter, randomly assigned, sham surgery-controlled, neither you nor the study doctors know who gets the real treatment study to assess how well it works and safety of bemdaneprocel in approximately 102 adults with Parkinson's Disease (PD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 102 people at 43 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.674Z"},{"nctId":"NCT06948084","title":"Testing the Investigational Medication Combination of Daratumumab and Teclistamab Compared to the Usual Treatment (Daratumumab, Pomalidomide, Dexamethasone or Daratumumab, Carfilzomib, Dexamethasone) for Patients With High-risk Multiple Myeloma Refractory or in First Relapse","officialTitle":"A Randomized Phase II Trial for High-Risk Multiple Myeloma That is Refractory or in First Relapse With Daratumumab, Teclistamab (DT) Versus Daratumumab, Pomalidomide, Dexamethasone (DPd) or Daratumumab, Carfilzomib, Dexamethasone (DKd)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells, including myeloma cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Teclistamab is a bispecific antibody that can bind to two different antigens at the same time. Teclistamab binds to B-cell maturation antigen, a protein found on some B-cells and myeloma cells, and CD3 on T-cells (a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Pomalidomide is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Carfilzomib, a type of proteasome inhibitor, blocks the action of enzymes called proteasomes, which may help keep cancer cells from growing and may kill them. Giving daratumumab and teclistamab may be more effective than the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in reducing myeloma cells to undetectable levels in patients with relapsed or refractory multiple myeloma.","conditions":["Recurrent Multiple Myeloma","Refractory Multiple Myeloma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"DRUG","name":"Carfilzomib"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Daratumumab and Recombinant Human Hyaluronidase"},{"type":"DRUG","name":"Dexamethasone"},{"type":"PROCEDURE","name":"FDG-Positron Emission Tomography"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Teclistamab"}],"enrollment":80,"startDate":"2027-05-22","completionDate":"2028-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient must be ≥ 18 years of age\n* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)\n* Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay\n* Patient must have received only one prior line of therapy\n\n  * One prior line of systemic therapy is defined as 1 or more cycles of single agent or combination therapy, as well as a series of treatment regimens administered in a sequential manner (e.g., lenalidomide, bortezomib and dexamethasone induction therapy for 4 cycles followed by autologous stem cell transplantation and then lenalidomide +/- proteasome inhibitor or anti-CD38 monoclonal antibody \\[mAb\\] maintenance therapy would be considered 1 line of prior therapy)\n  * NOTE: Autologous stem cell transplant is allowed provided the stem cell infusion was \\> 90 days prior to randomization. Allogeneic stem cell transplantation (SCT) patients are ineligible\n* Patient must be diagnosed with relapsed or refractory (RR) multiple myeloma, as defined by disease progression, either an increase in serum or urine M protein of any level, or other evidence of progression biochemical or clinical as specified in the IMWG progression criteria (including disease which becomes non-responsive or progressive on therapy or within 60 days of the last treatment in patients who had achieved a partial response or better on prior therapy)\n* Patient must be daratumumab-hyaluronidase (or isatuximab) naïve or daratumumab-hyaluronidase (or isatuximab) sensitive and \\> 180 days from their last dose of daratumumab-hyaluronidase (or isatuximab) at the time of randomization\n* Patient must have high-risk multiple myeloma (HR-MM) as defined by one of the following either at diagnosis or at refractory status or at first relapse:\n\n  * Evidence of deletion 17p by fluorescence in situ hybridization (FISH) testing on bone marrow\n  * Evidence of t(4;14) by FISH testing on bone marrow\n  * Evidence of t(14;16) by FISH testing on bone marrow\n  * Evidence of t(14;20) by FISH testing on bone marrow\n  * Evidence of chromosome 1 abnormalities either gain/amp 1q or deletion 1p by FISH testing on bone marrow OR\n  * Evidence of non-hyperdiploid karyotype OR\n  * Revised International Staging System (R-ISS) stage III beta2 microglobulin ≥ 5.5 mg/L and serum lactate dehydrogenase (LDH) \\> institutional upper limit of normal (ULN) OR\n  * Patient in first relapse and ≤ 24 months from the start of induction for both allogeneic stem cell transplantation (ASCT) eligible or ASCT ineligible patients (regardless of FISH, cytogenetic or RISS stage)\n* Patient must have measurable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:\n\n  * Serum M protein ≥ 0.5 g/dL (≥ 5 g/L)\n  * Urine M protein ≥ 200 mg/24 hours\n  * Serum free light chain (FLC) assay: Involved free light chain level ≥ 10 mg/dL (≥ 100 mg/L) provided serum FLC ratio is abnormal (\\< 0.26 or \\> 1.65)\n  * Exception: patients without measurable disease in the serum or urine, but with bone or soft tissue plasmacytoma(s) ≥ 2 cm or who have bone marrow plasma cells ≥ 30% are eligible on study\n* Patient must have serum protein electrophoresis (SPEP), urine protein electrophoresis (UPEP), and serum FLC assays along with bone marrow biopsy or aspirate performed within 28 days prior to randomization\n\n  * NOTE: UPEP (on a 24 hour collection) is required, no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr. If both serum and urine M-components are measurable, both must be followed in order to confirm response\n  * NOTE: The serum free light chain test is required to be done at each cycle\n* Patient must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or investigator's brochure), or known sensitivity to mammalian-derived products\n* Patients who have received prior systemic therapy for myeloma, including experimental therapy and steroids must have recovered from clinically significant adverse events prior to randomization\n* Patient may not be on steroids (prednisone \\> 40mg/day or equivalent) at the time of randomization\n* Patient may have received prior palliative and/or localized radiation, provided that it is completed by the time of randomization\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible\n* Absolute neutrophil count (ANC) ≥ 1,000/uL (=\\< 28 days prior to protocol randomization)\n* Untransfused platelet count ≥ 50,000/uL (for patients with ≥ 50% plasma cells in the marrow) and untransfused platelet count \\> 75,000/uL (for patients with \\< 50% plasma cells in the marrow) (=\\< 28 days prior to protocol randomization)\n* Untransfused hemoglobin ≥ 8.0 g/dL (=\\< 28 days prior to protocol randomization)\n* Total bilirubin ≤ 1.5 x institutional ULN (upper limit of normal) (=\\< 28 days prior to protocol randomization)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 × institutional ULN (=\\< 28 days prior to protocol randomization)\n* Calculated creatinine clearance \\> 30 mL/min (=\\< 28 days prior to protocol randomization)\n\n  * NOTE: Cockcroft-Gault equation should be used to calculate creatinine clearance\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 prior to randomization to rule out pregnancy. Patients randomized to Arm A and to receive the daratumumab-hyaluronidase, pomalidomide, dexamethasone (DPd) regimen must also have a second pregnancy test within 24 hours prior to the first dose of pomalidomide and agree to ongoing pregnancy testing while on protocol treatment\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and for 5 months after the last dose of protocol treatment for patients on Arm B and for 3 months after the last dose of protocol treatment for patients on Arm A. In addition, patients randomized to Arm A and receive the daratumumab-hyaluronidase, pomalidomide, dexamethasone (DPd) regimen must also agree to register to the mandatory Risk Evaluation and Mitigation Strategies (REMS®) program and be willing and able to comply with the requirements of the REMS program. All patients must not breastfeed while on protocol treatment and for patients on Arm B they must not breastfeed for an additional 5 months after the last dose of protocol treatment\n* Patient may have primary plasma cell leukemia (pPCL), secondary plasma cell leukemia (sPCL) or extramedullary myeloma (EMM)\n* Patient must not have evidence of active or untreated central nervous system (CNS) positive MM. Patients with prior CNS involvement are eligible provided they had demonstrated evidence of CNS disease resolution by imaging and/or 2 consecutively negative cerebrospinal fluid (CSF) samples for the presence of plasma cells\n* Patient must not have active autoimmune disease\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients with a history of chronic obstructive pulmonary disease (COPD) must have forced expiratory volume in 1 second (FEV1) testing done within 28 days prior to randomization and the forced expiratory volume in 1 second (FEV1) must be \\>= 50% of predicted normal\n* Patient must not have moderate or severe persistent asthma within 2 years prior to randomization\n\n  * NOTE: Patients who currently have controlled intermittent asthma or controlled mild persistent asthma are eligible\n* Investigator must declare the intended chemotherapy regimen at the time of randomization should their patient be randomized to Arm A from the two options","locations":[{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Bloomington","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Canton","city":"Canton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Carthage","city":"Carthage","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois - Decatur","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Decatur Memorial Hospital","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Eureka","city":"Eureka","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Galesburg","city":"Galesburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Kewanee Clinic","city":"Kewanee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Macomb","city":"Macomb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HSHS Saint Elizabeth's Hospital","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Ottawa Clinic","city":"Ottawa","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Pekin","city":"Pekin","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peoria","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peru","city":"Peru","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Princeton","city":"Princeton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois University School of Medicine","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Memorial Hospital","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare - Washington","city":"Washington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates at Mercy Medical Center","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU Health Baton Rouge-North Clinic","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Our Lady of the Lake Physician Group","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Hospital of Anaconda","city":"Anaconda","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic Cancer Center","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Benefis Sletten Cancer Institute","city":"Great Falls","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Logan Health Medical Center","city":"Kalispell","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Medical Center","city":"Missoula","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Minimal residual disease (MRD) negativity"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["coeur-dalene-idaho","post-falls-idaho","sandpoint-idaho","bloomington-illinois","canton-illinois","carthage-illinois","decatur-illinois","eureka-illinois","galesburg-illinois","kewanee-illinois","macomb-illinois","ofallon-illinois","ottawa-illinois","pekin-illinois","peoria-illinois","peru-illinois","princeton-illinois","springfield-illinois","washington-illinois","cedar-rapids-iowa","baton-rouge-louisiana","anaconda-montana","billings-montana","great-falls-montana","kalispell-montana","missoula-montana"],"enrichment":{"headline":"Phase 2: testing Carfilzomib for Recurrent Multiple Myeloma","inPlainEnglish":"This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed). Daratumumab is in a class of medications called monoclonal antibodies.","whoItsFor":["Ages 18 Years to any","Patient must be ≥ 18 years of age","Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2 (PS 3 allowed if secondary to pain)","Patient must have an identifiable dominant sequence (clonotype) established based on Adaptive Biotechnologies clonoSEQ® assay","Patient must have received only one prior line of therapy","NOTE: Autologous stem cell transplant is allowed provided the stem cell infusion was \\> 90 days prior to randomization. Allogeneic stem cell transplantation (SCT) patients are ineligible","Patient must be daratumumab-hyaluronidase (or isatuximab) naïve or daratumumab-hyaluronidase (or isatuximab) sensitive and \\> 180 days from their last dose of daratumumab-hyaluronidase (or isatuximab) at the time of randomization","Patient must have high-risk multiple myeloma (HR-MM) as defined by one of the following either at diagnosis or at refractory status or at first relapse:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Marrow Biopsy, or Carfilzomib. The registry lists allocation as randomized. This phase II trial compares the effect of the combination of daratumumab-hyaluronidase (daratumumab) and teclistamab to the usual treatment of daratumumab, pomalidomide, dexamethasone or daratumumab, carfilzomib and dexamethasone in treating patients with multiple myeloma that has not responded to previous treatment (refractory) or that has come back after a period of improvement (relapsed).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at 32 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.504Z"},{"nctId":"NCT06948110","title":"Deciphering the Genetic Architecture of Autoimmune Diseases","officialTitle":"Deciphering the Genetic Architecture of Autoimmune Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Human Genome Research Institute (NHGRI)","sponsorClass":"NIH","summary":"Background:\n\nAutoimmune diseases can be caused by genes people inherit from their parents. The gene changes that cause these diseases have been well studied in people with European and Asian ancestors. But some diseases behave differently in people who are native to North and South America. Researchers want to know more about the gene changes and other factors that may cause autoimmune diseases among these people. This project will be based in Peru.\n\nObjective:\n\nTo study how gene changes can lead to autoimmune diseases in people native to Peru.\n\nEligibility:\n\nPeople aged 18 years and older with an autoimmune disease. These may include systemic lupus erythematosus; Sjogren disease; scleroderma; rheumatoid arthritis; seronegative spondylo-arthropathies; and systemic vasculitis. Family members and healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have 2 clinic visits; these will be 2 weeks apart. The clinics will be in Lima, Iquitos, and other sites in Peru.\n\nVisit 1: Participants will have a physical exam. They will answer questions about their health risks and habits. They will provide blood and urine samples.\n\nVisit 2: Participants will provide a second blood sample and a stool sample. They will talk about the results of their first clinical exam with researchers.\n\nThe cost of travel to and from the clinics will be provided. Participants will get $30 per visit and a snack.","conditions":["Autoimmune Diseases"],"keywords":["Systemic Lupus Erythematosus"],"interventions":[],"enrollment":300,"startDate":"2026-11-15","completionDate":"2030-04-22","sex":"ALL","minAge":"18 Years","maxAge":"115 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAny person who meets the criteria for inclusion in the study will be considered and must have the patient's signed informed consent for participation.\n\nAutoimmune Disease Diagnosis:\n\nCases:\n\n* Patients diagnosed with SLE, Sjogren's disease, scleroderma, rheumatoid arthritis, seronegative spondyloarthropathies, and systemic vasculitis, as defined by the American College of Rheumatology classification criteria.\n* Over 18 years old\n\nControls:\n\n* Family members of identified cases, and unrelated individuals. The controls would be from the same community as the patients and families studied, and of the same age and gender. Screening for autoimmune diseases and allergic diseases will be performed.\n* Over 18 years old\n\nEXCLUSION CRITERIA:\n\n-People diagnosed with a chronic viral disease: HIV, hepatitis C or HTLV-1.","locations":[{"facility":"National Human Genome Research Institute (NHGRI)","city":"Bethesda","state":"Maryland","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Amazon Rainforest","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cristina M Lanata, M.D.","phone":"(301) 451-2302","email":"cristina.lanata@nih.gov"}],"primaryOutcomes":["whole-genome sequencing"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["bethesda-maryland","lima-peru"],"enrichment":{"headline":"Deciphering the Genetic Architecture of Autoimmune Diseases","inPlainEnglish":"Background: Autoimmune diseases can be caused by genes people inherit from their parents. The gene changes that cause these diseases have been well studied in people with European and Asian ancestors.","whoItsFor":["Ages 18 Years to 115 Years","Autoimmune Disease Diagnosis:","Patients diagnosed with SLE, Sjogren's disease, scleroderma, rheumatoid arthritis, seronegative spondyloarthropathies, and systemic vasculitis, as defined by the American College of Rheumatology classification criteria","Family members of identified cases, and unrelated individuals. The controls would be from the same community as the patients and families studied, and of the same age and gender. Screening for autoimmune diseases and allergic diseases will be performed"],"whoShouldSkip":["People diagnosed with a chronic viral disease: HIV, hepatitis C or HTLV-1"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.264Z"},{"nctId":"NCT06949280","title":"Metabolic Health, Bones and Nuts During Weight Loss in Adults","officialTitle":"Metabolic Health, Bones and Nuts Sources of Fatty Acids During Weight Loss in Adults","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Rutgers, The State University of New Jersey","sponsorClass":"OTHER","summary":"The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults. Studies have shown that regular nut consumption is associated with lower adiposity and reduced weight gain, and several dietary pattern studies indicate that nuts and legumes are associated with better bone health. In addition, our preliminary translational data indicates that a higher monounsaturated fatty acid (MUFA) intake is associated with improved bone mineral density (BMD) and quality. Given these findings, the proposed study aims to examine the impact of consuming peanut products on bone health, metabolic health (e.g., serum glucose, insulin, lipids and inflammation), markers of brain and sleep health, and physical function in overweight and obese older adults before and after a six-month weight loss intervention using a randomized controlled design. The results of this study have the potential to provide valuable insights into the role of peanuts as a sources of fatty acids in promoting health and preventing disease in at-risk adults.","conditions":["Weight Loss","Bone Density","Obesity and Overweight"],"keywords":["weight loss","adults","bone","cognition","metabolic health","sleep","peanut","Monounsaturated fatty acid"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Peanut Snack Experimental"},{"type":"DIETARY_SUPPLEMENT","name":"Nut-free Snack"}],"enrollment":44,"startDate":"2025-10-30","completionDate":"2027-12-31","sex":"ALL","minAge":"50 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Men and postmenopausal women (\\>2 years since last menses), ages 50-75 years\n* Body mass index (25-42 kg/m2) or evidence of pre-clinical obesity.\n* Agree to be randomly assigned to consume a daily peanut snack or nut-free snack for 24 weeks\n* Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)\n\nExclusion Criteria:\n\n* Peanut allergies or intolerances\n* Individuals with \\>5% weight loss in the past 3 months or those with extreme dietary/physical activity habits.\n* An inability to follow the experimental intervention or to perform the required specimen collections.\n* Individuals with significant psychiatric or food disorders.\n* Current diagnosis, or history of cancer in past 3 years.\n* Current diagnosis or history of bone diseases, type I or II diabetes if using insulin, gastrointestinal disease, hyperparathyroidism, Alzheimer's disease, mild cognitive impairment, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease.\n* History of major surgery in the past 6 months\n* Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.\n* Regular use of medications for cholecystitis, urinary tract infection, severe organic diseases including coronary heart disease, myocardial infarction, infectious diseases including pulmonary tuberculosis and AIDS.\n* Alcohol or illicit drug abuse\n* Any other condition deemed by the Research Physician that would prevent participation in the study, e.g. participation in another clinical research project that may interfere with the results of this study.\n* Participation in another clinical interventional research trial","locations":[{"facility":"Rutgers University - NJ Inst Food Nutrition & Health","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Principal Investigator","phone":"848-932-9403","email":"shapses@rutgers.edu"},{"name":"Research Manager","phone":"","email":"ru-nextnutrition@sebs.rutgers.edu"}],"primaryOutcomes":["Bone Mineral Density (BMD - total hip)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["new-brunswick-new-jersey"],"enrichment":{"headline":"Not a traditional drug phase: Peanut Snack Experimental for Weight Loss","inPlainEnglish":"The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group. Legumes, such as peanuts, are a plant-based food high in protein and unsaturated fat making this a healthy choice but are not consumed frequently enough in older adults.","whoItsFor":["Ages 50 Years to 75 Years","Men and postmenopausal women (\\>2 years since last menses), ages 50-75 years","Body mass index (25-42 kg/m2) or evidence of pre-clinical obesity","Agree to be randomly assigned to consume a daily peanut snack or nut-free snack for 24 weeks","Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)"],"whoShouldSkip":["Peanut allergies or intolerances","Individuals with \\>5% weight loss in the past 3 months or those with extreme dietary/physical activity habits","An inability to follow the experimental intervention or to perform the required specimen collections","Individuals with significant psychiatric or food disorders","Current diagnosis, or history of cancer in past 3 years","Current diagnosis or history of bone diseases, type I or II diabetes if using insulin, gastrointestinal disease, hyperparathyroidism, Alzheimer's disease, mild cognitive impairment, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease","History of major surgery in the past 6 months"],"whatHappens":"If you join, the listed intervention(s) are Peanut Snack Experimental, or Nut-free Snack. The registry lists allocation as randomized. The aging population is rapidly increasing, and it is important to identify dietary factors that can prevent disease and promote health in this group.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 44 people at New Brunswick. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.836Z"},{"nctId":"NCT06951100","title":"Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation","officialTitle":"Mechanisms of Myocardial Injury and Ischemia in Patients With Rapid Atrial Fibrillation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Edinburgh","sponsorClass":"OTHER","summary":"The goal of this observational study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF)\n\nThe main questions this study aims to answer are:\n\n1. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease)\n2. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) with further evidence that their heart hasn't been getting enough oxygen (myocardial ischemia) more likely to have imaging evidence of myocardial infarction than those without myocardial ischemia\n\nTo do this, we will measure troponin in patients with rapid AF and then carry out further investigations of the heart (electrocardiogram, echocardiogram, CT scan and cardiac MRI)","conditions":["Atrial Fibrillation (AF)"],"keywords":["Atrial Fibrillation","Cardiology","Emergency Medicine","Myocardial Infarction","Myocardial Ischemia","Coronary Artery Disease"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"CT coronary angiography"}],"enrollment":300,"startDate":"2025-05-01","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years and over\n2. Primary presentation with symptoms related to atrial fibrillation\n3. Atrial fibrillation with a ventricular rate \\>100 bpm on a 12-lead electrocardiogram\n4. Able to provide informed consent\n\nExclusion Criteria\n\n1. Previous myocardial infarction\n2. Previous coronary revascularisation procedure\n3. Patients in renal failure (eGFR \\<30ml/min/1.73m2) or major allergy to contrast media\n4. Pregnancy or breast feeding\n5. Deemed unsuitable for participation in the study by the attending clinician\n6. Previous enrolment in the trial","locations":[{"facility":"Royal Infirmary of Edinburgh","city":"Edinburgh","state":"East of England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Presence of obstructive coronary artery disease"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["edinburgh-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: CT coronary angiography for Atrial Fibrillation (AF)","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to better understand the role of measuring troponin (a protein measured by a blood test) and coronary imaging in patients presenting with rapid atrial fibrillation (AF) The main questions this study aims to answer are: 1. Are patients with a fast, irregular heartbeat (rapid AF) and damage to the heart (myocardial injury) more likely than those without damage to the heart to have blocked heart arteries (obstructive coronary artery disease) 2.","whoItsFor":["Ages 18 Years to any","Age 18 years and over","Primary presentation with symptoms related to atrial fibrillation","Atrial fibrillation with a ventricular rate \\>100 bpm on a 12-lead electrocardiogram"],"whoShouldSkip":["Previous myocardial infarction","Previous coronary revascularisation procedure","Patients in renal failure (eGFR \\<30ml/min/1.73m2) or major allergy to contrast media","Pregnancy or breast feeding","Deemed unsuitable for participation in the study by the attending clinician","Previous enrolment in the trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Edinburgh. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.750Z"},{"nctId":"NCT06951698","title":"A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder","conditions":["Bipolar-I Disorder With Mania or Mania With Mixed Features"],"keywords":["Bipolar-I","Mania","Mixed"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"OTHER","name":"Placebo"}],"enrollment":274,"startDate":"2025-06-11","completionDate":"2026-11-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.\n* Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).\n* Participants must require hospitalization for the acute exacerbation or relapse of mania.\n* Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.\n* Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.\n* Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.\n\nExclusion Criteria:\n\n* Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.\n* Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).\n* Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.\n* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).\n* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.\n* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 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0047","city":"Iași","state":"","country":"Romania","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Spitalul de Psihiatrie și Neurologie Brașov","city":"Sanpetru /Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"EPAMED - Košice - Hlavná","city":"Košice","state":"Košice Region","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univerzitna Nemocnica L. Pasteura Kosice","city":"Košice","state":"Košice Region","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crystal Comfort","city":"Vranov nad Topľou","state":"Presov","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0069","city":"Barcelona","state":"Barcelona [Barcelona]","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0039","city":"Bilbao","state":"Basque Country","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0044","city":"Barcelona","state":"Catalunya [Cataluña]","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0077","city":"Nacka","state":"Stockholms Län [se-01]","country":"Sweden","status":"COMPLETED","lat":null,"lon":null},{"facility":"Local Institution - 0067","city":"Uppsala","state":"Uppsala Län [se-03]","country":"Sweden","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0070","city":"Gothenburg","state":"Västra Götalands Län [se-14]","country":"Sweden","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC","city":"Dnipro","state":"Dnipropetrovsk Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Non-Commercial Enterprise \"Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council","city":"Kropyvnytskyi","state":"Kirovohrad Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal non-commercial enterprise of the Kyiv Regional Council \"Regional Psychiatric-Narcological Medical Association\"","city":"Hlevakha","state":"Kyiv Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Non-Commercial Enterprise \"Odesa Regional Medical Centre of Mental Health\" of Odesa Regional Council","city":"Oleksandrivka","state":"Odesa Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal non-profit enterprise \"Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC\"","city":"Vinnytsia","state":"Vinnytsia Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Non-Commercial Enterprise \"Odesa Regional Medical Centre of Mental Health\" of Odesa Regional Council","city":"Odesa","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Enterprise \"Regional Institution of Mental Psychiatric Care of the Poltava Regional Council\"","city":"Poltava","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Change from baseline in Young Mania Rating Scale (YMRS) score"],"hasResults":false,"conditionSlugs":["als","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","rogers-arkansas","culver-city-california","riverside-california","torrance-california","boynton-beach-florida","hialeah-gardens-florida","hollywood-florida","miami-florida","miami-lakes-florida","miami-springs-florida","tampa-florida","atlanta-georgia","decatur-georgia","chicago-illinois","gaithersburg-maryland","flowood-mississippi","st-louis-missouri","north-las-vegas-nevada","marlton-new-jersey","charlotte-north-carolina","cincinnati-ohio","north-canton-ohio","desoto-texas","houston-texas","richardson-texas","beijing-china","wuhan-china","changsha-china","jining-shi-china","tianjin-china","zagreb-croatia","visakhapatnam-india","vadodara-india","belagavi-india","kozhikode-india","ludhiana-india","madurai-india","hyderabad-india","kolkata-india","hod-hasharon-israel","ness-ziona-israel","petah-tikva-israel","ramat-gan-israel","beersheba-israel","jerusalem-israel","milan-italy","pisa-italy","siena-italy","ancona-italy","genova-italy","bucharest-romania","ia-i-romania","sanpetru-brasov-romania","ko-ice-slovakia","vranov-nad-top-ou-slovakia","barcelona-spain","bilbao-spain","nacka-sweden","uppsala-sweden","gothenburg-sweden","dnipro-ukraine","kropyvnytskyi-ukraine","hlevakha-ukraine","oleksandrivka-ukraine","vinnytsia-ukraine","odesa-ukraine","poltava-ukraine"],"enrichment":{"headline":"Phase 3: testing KarXT for Bipolar Disorder Type I With Mania or Mania With Mixed Features","inPlainEnglish":"This is a Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to measure the how well it works of KarXT compared to dummy treatment (placebo) in treating symptoms of mania during a 3-week inpatient period.","whoItsFor":["Ages 18 Years to 65 Years","Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation","Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks)","Participants must require hospitalization for the acute exacerbation or relapse of mania","Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug","Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline","Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline"],"whoShouldSkip":["Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year)","Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test","Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS)","Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are KarXT, or Placebo. The registry lists allocation as randomized. This is a Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 274 people at 79 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.727Z"},{"nctId":"NCT06951867","title":"Tezspire Cardiac Events PASS","officialTitle":"An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.","conditions":["Cardiovascular Events","MACE"],"keywords":["post Marketing Requirements (PMR) study","cardiovascular events","non-fatal myocardial infarction","non-fatal stroke","cardiovascular death","arrythmias","coronary artery disease","heart failure","myocardial disorders"],"interventions":[{"type":"DRUG","name":"Tezepelumab"}],"enrollment":16640,"startDate":"2025-09-15","completionDate":"2029-05-31","sex":"ALL","minAge":"12 Years","maxAge":"130 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.\n\nExclusion Criteria for both exposed and unexposed groups include:\n\n* \\<12 months of data availability prior to index date,\n* age \\<12 years at index date,\n* history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date\n* for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic\n* matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \\[PS\\] matching) will be applied to ensure exposed and unexposed patients' comparability","locations":[{"facility":"Healthcare Integrated Research Database (HIRD)","city":"Wilmington","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Danish registries (access/analysis)","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"French National Health Data System (SNDS)","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Team Gesundheit GKV Claims data (SHI)","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["composite outcome MACE"],"hasResults":false,"conditionSlugs":["stroke","heart-failure","asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["wilmington-delaware","copenhagen-denmark","paris-france","berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: testing Tezepelumab for Cardiovascular Events","inPlainEnglish":"The aim of this study is to measure the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.","whoItsFor":["Ages 12 Years to 130 Years","patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period"],"whoShouldSkip":["for both exposed and unexposed groups include:","\\<12 months of data availability prior to index date,","age \\<12 years at index date,","history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date","for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic","matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \\[PS\\] matching) will be applied to ensure exposed and unexposed patients' comparability"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 16,640 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.862Z"},{"nctId":"NCT06951919","title":"HOBSCOTCH-MS-Efficacy Trial","officialTitle":"HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) - Multiple Sclerosis (MS) - Efficacy Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Dartmouth-Hitchcock Medical Center","sponsorClass":"OTHER","summary":"The purpose of this study is to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden. Enrolling with a Caregiver is optional for MS participants.\n\nInvestigators will compare two groups of MS participants and their Caregiver (enrolling with a Caregiver is optional): one who receives HOBSCOTCH-MS immediately (Group 1) and another group that will receive HOBSCOTCH-MS (Group 2) after a 3-month waiting period. Participants will be in the study for about 6 months total.\n\nHOBSCOTCH-MS involves 45 to 60 minute one on one virtual sessions with a certified Cognitive Coach including a \"pre\" program session and 8 weekly sessions thereafter. Participants will learn about problem solving therapy and mindfulness or relaxation training. MS participants are asked to do short homework assignments and both MS and Caregiver participants are asked to keep a brief daily diary on a smart phone app. All participants complete study questionnaires or surveys at enrollment, 3 months later and at 6 months (at the end of the study).\n\nAfter completing the intervention, MS Participants and their Caregivers may also participate in an optional one-time Key Informant Interview for qualitative analysis in an effort to further adapt and improve the HOBSCOTCH-MS in the future.","conditions":["Multiple Sclerosis","Cognitive Dysfunction","Memory Disorders","Memory Impairment","Memory Dysfunction"],"keywords":["Cognition","Self-Management","Cognitive Remediation","Cognitive Training","Memory Disorders","Caregivers","Caregiver Burden","Mindfulness"],"interventions":[{"type":"BEHAVIORAL","name":"Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS)"}],"enrollment":125,"startDate":"2025-09-09","completionDate":"2028-05","sex":"ALL","minAge":"20 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion Criteria - MS Participant\n\n  * Age 20 - 75 years\n  * Diagnosis of relapsing or progressive MS\n  * Education of at least Grade 12 or GED\n  * Fluent in English\n  * Subjective cognitive and memory challenges\n  * Internet access\n  * Telephone access\n\nInclusion Criteria - Caregiver Participant\n\n* 20 years +\n* Fluent in English\n* Caregiver to a MS Participant\n* Participant MS has given permission to Caregiver to enroll with them\n* Internet access\n* Telephone access\n\nExclusion Criteria:\n\n* Exclusion Criteria MS Participant\n\n  * Current diagnosed psychiatric disorders (e.g., schizophrenia, bipolar disorder or substance use disorder).\n  * Other neurological disorder such as epilepsy, brain tumor, severe brain injury or mild to moderate brain injury with a history of 30 or more minutes' loss of consciousness, or other disorder that would confound the focus on MS\n  * Diagnosed developmental attention, learning, or intellectual disorder; sensory, motor, or physical disability that would prevent engagement with the intervention or render the person unable complete study outcome measures\n  * Exacerbation of MS symptoms (relapse) or ongoing steroid treatment within three months of study enrollment\n  * Significant visual impairment precluding reading or writing\n  * Lack of access to the technical resources (e.g., internet access, telephone) required for participation\n\nExclusion Criteria - Caregiver Participant\n\n* Significant visual impairment precluding reading or writing\n* No reliable telephone or internet access","locations":[{"facility":"Dartmouth-Health Lebanon","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meredith E Olenec","phone":"603-650-4225","email":"HOBSCOTCH-MS.Research@Hitchcock.org"},{"name":"Sarah J Kaden","phone":"603-650-4225","email":"HOBSCOTCH-MS.Research@Hitchcock.org"}],"primaryOutcomes":["Change in quality of life in MS participants as measured by comparing PROMIS-10 Global Health scores at baseline and at 3 months post-intervention.","Change in subjective cognitive function in MS participants as measured by comparing scores on the Cognitive Function Sub-Scale (Item Bank 2.0) of the Neuro-QOL at baseline and at 3 months post-intervention.","Change in Caregiver participants caregiver burden as measured by comparing Zarit Burden Interview scores at baseline and at 3 months post-intervention."],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["lebanon-new-hampshire"],"enrichment":{"headline":"Not a traditional drug phase: Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS) for Multiple Sclerosis","inPlainEnglish":"This study wants to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants). This study will also assess the ability of the HOBSCOTCH-MS program to improve quality of life in caregivers of patients with multiple sclerosis and to reduce caregiver burden.","whoItsFor":["Ages 20 Years to 75 Years","who can join - MS Participant","Diagnosis of relapsing or progressive MS","Education of at least Grade 12 or GED","Subjective cognitive and memory challenges","who can join - Caregiver Participant","Caregiver to a MS Participant","Participant MS has given permission to Caregiver to enroll with them"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Home Based Self- management and Cognitive Training Changes lives in Multiple Sclerosis (HOBSCOTCH-MS). The registry lists allocation as randomized. This study wants to assess the ability of the home-based intervention, HOBSCOTCH-MS to improve the quality of life and cognitive function in Service Members, Veterans and civilians who have multiple sclerosis with cognitive and memory problems (MS participants).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 125 people at Lebanon. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.978Z"},{"nctId":"NCT06952504","title":"A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)","officialTitle":"A Phase 3 Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone as First-line Maintenance Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (TroFuse-033/GOG-3119/ENGOT-en29)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.\n\n* EC is a type of cancer that starts in the tissues inside the uterus (womb)\n* pMMR indicates that certain normal proteins are present in the cancer cells\n* Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery\n* Recurrent means the cancer came back after surgery\n\nSacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.","conditions":["Endometrial Cancer"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Trophoblast cell surface antigen 2 (TROP2)"],"interventions":[{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Docetaxel"},{"type":"BIOLOGICAL","name":"Sacituzumab Tirumotecan"},{"type":"DRUG","name":"Cisplatin"}],"enrollment":1123,"startDate":"2025-05-22","completionDate":"2032-05-24","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key inclusion criteria include but are not limited to:\n\n* Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)\n* Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator\n* Has received no prior systemic therapy for endometrial carcinoma except the following conditions as pre-specified by the protocol: 1 prior line of systemic platinum-based adjuvant and/or neoadjuvant chemotherapy in the setting of curative-intent, prior radiation with or without radiosensitizing chemotherapy if \\>2 weeks before the start of induction treatment, or prior hormonal therapy for treatment of endometrial carcinoma that was discontinued ≥1 week before the start of induction treatment\n\nKey exclusion criteria include but are not limited to:\n\n* Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas\n* Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)\n* Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Human Immunodeficiency Virus-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Received prior therapy in any setting with any of the following: anti-programmed cell death 1 protein, anti-programmed cell death ligand 1, anti-programmed cell death ligand 2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor; trophoblast cell surface antigen 2-targeted antibody drug conjugate; or topoisomerase I inhibitor-containing antibody drug conjugate","locations":[{"facility":"University of South Alabama, Mitchell Cancer Institute ( Site 6033)","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care ( Site 6036)","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5014)","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 6020)","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sansum Clinic (Ridley Tree) ( Site 8007)","city":"Solvang","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Muir Health Cancer Center ( Site 6028)","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University School of Medicine ( Site 6009)","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Washington Hospital Center ( Site 5005)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - South ( Site 7003)","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health Davis Cancer Pavilion and Shands Med Plaza ( Site 6026)","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Braman Comprehensive Cancer Center ( Site 6031)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 6002)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists ( Site 7002)","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists East ( Site 7001)","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph's/Candler Health System ( Site 6021)","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center ( Site 5002)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkview Research Center ( Site 6008)","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Cancer Care ( Site 6010)","city":"Covington","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TRIALS 365 ( Site 6005)","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maine Medical Center - Scarborough Campus ( Site 6042)","city":"Scarborough","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center ( Site 6052)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minnesota Oncology Hematology, PA ( Site 8003)","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Dominic's Hospital ( Site 5004)","city":"Jackson","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University - School of Medicine ( Site 5006)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Center of Hope ( Site 5018)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holy Name Medical Center ( Site 6011)","city":"Teaneck","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico Comprehensive Cancer Center ( Site 6046)","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 6055)","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6004)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center ( Site 6053)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute ( Site 6049)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FirstHealth of the Carolinas ( Site 6037)","city":"Pinehurst","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Valley Hospital South ( Site 6014)","city":"Centerville","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center ( Site 5013)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6007)","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kettering Health Main Campus-Kettering Health Cancer Center ( Site 5001)","city":"Kettering","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center, Stephenson Cancer Center ( Site 6012)","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6047)","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates of Oregon, P.C. ( Site 8005)","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's University Health Network ( Site 6041)","city":"Bethlehem","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of the University of Pennsylvania ( Site 5007)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of the University of Pennsylvania ( Site 6023)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"AHN West Penn Hospital ( Site 6006)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women & Infants Hospital ( Site 5003)","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erlanger Medical Center ( Site 5009)","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8004)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital ( Site 6057)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology-San Antonio Medical Center ( Site 8001)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas ( Site 8002)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Gulf Coast ( Site 8006)","city":"Webster","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute ( Site 6003)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists (VCS) ( Site 8008)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Health Adult Outpatient Pavillion ( Site 5000)","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0105)","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clínicas Mar del Plata ( Site 0108)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar ( Site 0101)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Británico de Buenos Aires ( Site 0103)","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto San Marcos ( Site 0106)","city":"San Juan","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blacktown Hospital ( Site 0201)","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Brisbane and Women's Hospital ( Site 0206)","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epworth Freemasons ( Site 0207)","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Charles Gairdner Hospital ( Site 0203)","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universität Graz-Abteilung für Gynäkologie / Onkologie ( Site 0303)","city":"Graz","state":"Styria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 0301)","city":"Innsbruck","state":"Tyrol","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universität Wien - Allg. Gynaekologie & Gyn. Onkologie ( Site 0302)","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Saint-Pierre ( Site 0405)","city":"Brussels","state":"Bruxelles-Capitale, Region de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Maria Middelares ( Site 0402)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven ( Site 0401)","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Hôpital de Charleroi ( Site 0403)","city":"Charleroi","state":"Wallonne, Region","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Liege ( Site 0404)","city":"Liège","state":"Wallonne, Region","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Araújo Jorge ( Site 0521)","city":"Goiânia","state":"Goiás","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Câncer ( Site 0523)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital São Lucas da PUCRS ( Site 0522)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"IBCC - Instituto Brasileiro de Controle do Câncer ( Site 0525)","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Câncer - INCA ( Site 0515)","city":"Rio de Janeiro","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Cancer Surrey ( Site 0621)","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CancerCare Manitoba ( Site 0617)","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"NL Health Services ( Site 0602)","city":"St. John's","state":"Newfoundland and Labrador","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Victoria Regional Health Centre ( Site 0615)","city":"Barrie","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre ( Site 0611)","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sault Area Hospital ( Site 0616)","city":"Sault Ste. Marie","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Research Institute ( Site 0610)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Center ( Site 0609)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Windsor Regional Cancer Program ( Site 0614)","city":"Windsor","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0607)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0605)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital ( Site 0606)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre ( Site 0604)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. 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3: testing Pembrolizumab for Endometrial Cancer","inPlainEnglish":"Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines.","whoItsFor":["Ages 18 Years to any","Women only","Key include but are not limited to:","Has a histologically confirmed diagnosis of primary advanced or recurrent endometrial carcinoma that has been confirmed as proficient mismatch repair (pMMR)","Has radiographically evaluable disease, with measurable Stage III or either measurable or non-measurable Stage IV or recurrent disease per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1), as assessed by the investigator"],"whoShouldSkip":["include but are not limited to:","Has carcinosarcoma, neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of sarcomas","Has endometrial carcinoma of any histology that is mismatch repair deficient (dMMR)","Is a candidate for debulking surgery resulting in complete removal of all tumor and no evidence of radiological disease following surgery, or curative-intent radiotherapy at the time of enrollment","Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease"],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, Carboplatin, or Paclitaxel. The registry lists allocation as randomized. Researchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,123 people at 271 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.689Z"},{"nctId":"NCT06953089","title":"DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors","officialTitle":"A Phase II, Multicenter, Open-Label Trial of DB-1311 in Combination With BNT327 or DB-1305 in Participants With Advanced/Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"DualityBio Inc.","sponsorClass":"INDUSTRY","summary":"A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors","conditions":["Solid Tumors"],"keywords":["B7-H3","PD-L1/VEGF-A","TROP2 (Trophoblast cell surface antigen 2)","ADC (antibody-drug conjugate)","HNSCC (head and neck squamous cell carcinoma)","HCC (hepatocellular carcinoma)","Melanoma","NSCLC(non-small cell lung cancer)","OC (ovarian cancer)"],"interventions":[{"type":"DRUG","name":"DB-1311/BNT324"},{"type":"DRUG","name":"BNT327"},{"type":"DRUG","name":"DB-1305/BNT325"}],"enrollment":750,"startDate":"2025-07-18","completionDate":"2030-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Adults aged ≥ 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.\n* At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.\n* Has a life expectancy of ≥ 3 months.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1\n* Has adequate organ function within 7 days prior to enrollment/randomization,\n* Has adequate treatment washout period prior to the first dose of trial treatment.\n\n  * For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.\n  * For CC patients: Has persistent, recurrent or metastatic CC with squamous cell, adenocarcinoma, or adenosquamous histology\n  * For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic/stage IV melanoma.\n  * For PROC patients (Part 1, Cohort 1A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease.\n  * For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.\n  * For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations\n  * For PSOC (Part 2 Arm 6 only): Must have PSOC, defined as radiographically documented disease recurrence or progression occurring \\>6 months after completion of the last dose of platinum-based chemotherapy.\n  * For PDAC (Part 2 Arm 7 only): Participants with advanced/unresectable metastatic PDAC without AGA who have progressed after only one prior line of standard systemic treatments (2L PDAC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L PDAC with AGA).\n  * For breast cancer (Part 2 Arm 8 only):\n\n    * HR+/HER2-low or HR+/HER2-ultralow or HR+/HER2-negative BC participants: Pathologically or cytologically documented HR-positive unresectable or metastatic BC with HER2-low, HER2-ultralow or HER2-negative expression.\n    * Triple negative breast cancer (TNBC): Pathologically or cytologically documented unresectable or metastatic TNBC\n  * For mCRC (Part 2 Arm 9 only): Participants with advanced/unresectable mCRC without AGA who have progressed after only one prior line of standard systemic treatment (2L mCRC without AGA), or participants with AGA who have progressed on or after at least one and a maximum of two prior lines of standard systemic treatment (2L-3L mCRC with AGA).\n  * For mCRPC (Part 2 Arm 10 only): Participants must have histologically or cytologically confirmed adenocarcinoma of the prostate and mCRPC\n\nKey Exclusion Criteria:\n\n* 1\\. Prior treatment with B7H3 targeted therapy.\n* Prior treatment with antibody-drug conjugate with topoisomerase inhibitor.\n* Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment.\n* Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs.\n* Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy.\n* Has a history of (non-infectious) ILD/pneumonitis.\n* Any autoimmune, connective tissue or inflammatory disorders.\n* Has spinal cord compression or clinically active central nervous system (CNS) metastases.\n* Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.\n* Other protocol defined inclusion and exclusion criteria apply.","locations":[{"facility":"USA06-0","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA16-0","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA01-0","city":"Wheat Ridge","state":"Colorado","country":"United 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Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHN01-0","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHN24-0","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"TWN01-0","city":"Taipei","state":"Taipei","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"TWN02-0","city":"Taipei","state":"Taipei","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jay Ma","phone":"540-808-3925","email":"jay.ma@dualitybiologics.com"},{"name":"Qiaoli Jiang","phone":"+86-15210642683","email":"qiaoli.jiang@dualitybiologics.com"}],"primaryOutcomes":["Part 1: Number of participants with Dose Limiting Toxicities (DLTs).","Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs)","Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response by arm and dose level. (Arm 1-9).","ORR, defined as the proportion of participants in whom a confirmed CR or PR is observed as best overall response (per PCWG3-modified RECIST v1.1 as assessed by investigator) (Arm 10)."],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","ovarian-cancer","liver-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","wheat-ridge-colorado","florida-city-florida","atlanta-georgia","bethesda-maryland","lincoln-nebraska","new-york-new-york","portland-oregon","charleston-south-carolina","anderson-texas","houston-texas","virginia-beach-virginia","puyallup-washington","spokane-washington","north-sydney-australia","benowa-australia","birtinya-australia","adelaide-australia","beijing-china","dongguan-china","henan-china","xinxiang-china","hubei-china","wuhan-china","changsha-china","xuzhou-china","shenyang-china","xian-china","shanghai-china","chengdu-china","taipei-taiwan"],"enrichment":{"headline":"Phase 2: testing DB-1311/BNT324 for Solid Tumors","inPlainEnglish":"A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors","whoItsFor":["Ages 18 Years to any","At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria","Has a life expectancy of ≥ 3 months","Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1","Has adequate organ function within 7 days prior to enrollment/randomization,","Has adequate treatment washout period prior to the first dose of trial treatment","For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score","For CC patients: Has persistent, recurrent or metastatic CC with squamous cell, adenocarcinoma, or adenosquamous histology"],"whoShouldSkip":["1\\. Prior treatment with B7H3 targeted therapy","Prior treatment with antibody-drug conjugate with topoisomerase inhibitor","Is a candidate to locoregional treatment with potential to induce complete or near complete response and prolonged tumor control, per investigator's assessment","Has an uncontrolled concomitant or intercurrent illness, that in the opinion of the investigator, contra-indicates trial participation, limits compliance with trial procedures or substantially increases the risk of incurring AEs","Has uncontrolled or significant cardiovascular disease. Has clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy","Has a history of (non-infectious) ILD/pneumonitis","Any autoimmune, connective tissue or inflammatory disorders"],"whatHappens":"If you join, the listed intervention(s) are DB-1311/BNT324, BNT327, or DB-1305/BNT325. The registry lists allocation as randomized. A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or DB-1305 in Participants with Advanced/Metastatic Solid Tumors","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 750 people at 37 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.629Z"},{"nctId":"NCT06955169","title":"Comparing the Radiopharmaceutical Drug, [177Lu]Lu-DOTATATE, to Standard of Care Treatment for Patients With Meningioma That Has Come Back After Prior Treatment","officialTitle":"MOMENTUM-1: A Multicenter, Randomized, Open-Label, Phase II Study of [177LU]LU-DOTATATE in Adults With Progressive Intracranial Grade 1-3 Meningioma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"RTOG Foundation, Inc.","sponsorClass":"OTHER","summary":"This is an open-label, multicenter, randomized, phase 2 clinical study to evaluate the efficacy of \\[177Lu\\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.","conditions":["Intracranial Meningioma"],"keywords":["MOMENTUM-1","Meningioma","Advanced Intracranial Meningioma","SSTR2","Radiopharmaceuticals","Theranostics","Radioligand Therapy","Lu-DOTATATE","Lutathera"],"interventions":[{"type":"DRUG","name":"[177Lu]Lu-DOTATATE"},{"type":"OTHER","name":"Standard of Care treatments"}],"enrollment":130,"startDate":"2025-08-24","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nSTEP 1 REGISTRATION\n\n* Aged \\>= 18 years\n* Histologically confirmed diagnosis of WHO grade 1-3 meningioma\n* Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation.\n* The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation.\n* Presence of measurable contrast-enhancing disease on gadolinium-enhanced MRI brain scan defined as at least one lesion with two perpendicular diameters measuring ≥10 mm on two or more axial slices (≤ 5 mm interslice thickness, ≤ 1 mm interslice gap) per current RANO meningioma criteria\n* Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:\n* ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or\n* ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or\n* Development of a new measurable lesion\n* The following scans must be available for submission for central radiology review:\n* Pre-progression gadolinium-enhanced MRI brain scan no older than 12 months (379 days) that serves as a reference for evaluation of radiographic disease progression\n* Progression gadolinium-enhanced MRI brain scan\n\nSTEP 2 REGISTRATION\n\n* Progression of disease determined by central radiology review per current RANO meningioma criteria, defined as:\n* ≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or\n* ≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or\n* Development of a new measurable lesion.\n* \\[68Ga\\]Ga-DOTATATE uptake on PET-CT. Positive uptake is defined as uptake at least as high as liver, based on the uptake in at least one target lesion.\n* Both the patient and investigator must agree that the patient will NOT receive SSTR2-targeted therapy, surgical resection, or radiation therapy until progression of disease while on study treatment.\n* Patients must be willing and able to undergo regular MRI scans of the brain and \\[68Ga\\]Ga-DOTATATE PET-CT imaging during the study.\n* Patients must have recovered to CTCAE grade ≤1 or pretreatment baseline from clinically significant adverse events related to prior therapy (exclusions include alopecia, lymphopenia, sensory neuropathy ≤ grade 2, or other ≤ grade 2 not constituting a safety risk based on the investigator's judgment).\n* Adequate organ and bone marrow function as defined below (within 28 days prior to step 2 registration):\n* Absolute neutrophil count (ANC) ≥ 1500/mm3\n* Platelet count ≥ 75,000/mm3\n* Hemoglobin ≥ 8 g/dL\n* Creatinine clearance (calculated by the Cockroft-Gault method) ≥40mL/min\n* AST (SGOT) and ALT (SGPT) ≤ 3 x the laboratory upper limit of normal (ULN)\n* Total serum bilirubin ≤ 3 x ULN (except participants with Gilbert's Syndrome, who can have a total bilirubin ≤ 5 x ULN)\n* Potassium within normal limits.\n\nExclusion Criteria:\n\n* Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis.\n* Patients with radiation-associated meningiomas.\n* Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded.\n* Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies.\n* Unstable neurological symptoms requiring steroids to control symptoms at a dose of \\>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration.\n* Patients requiring immediate local therapy (e.g. surgical resection).\n* Surgical procedure within the timeframes listed below, prior to step 2 registration.\n* 28 days from any prior craniotomy\n* 7 days from stereotactic biopsy Note: There is no limit to the number of prior surgical interventions\n* Treatment within the timeframes specified below, prior to step 2 registration.\n* 28 days (or 5 half-lives, whichever is longer) for cytotoxic chemotherapy, biologic agent, investigational agent or any other systemic agent prescribed for the purpose of treating meningioma\n* 6 weeks from nitrosoureas Note: There is no limit to the number of prior systemically administered therapeutic agents.\n* A target lesion is excluded if it has received any of the following:\n* More than 2 total prior courses of radiation\n* More than 1 prior course of standard fractionated external beam radiation therapy (EBRT)\n* Radiation treatment to the target lesion completed \\<24 weeks (168 days) before Step 2 registration.\n\nFor purposes of this criterion, one course of EBRT counts as one course regardless of duration, and each course of stereotactic radiation (1-5 fractions) counts as one course. Accordingly, a target lesion may have received at most one prior course of EBRT plus one prior course of stereotactic radiation, or two prior courses of stereotactic radiation. Prior radiation history must be evaluated on a lesion-by-lesion basis, including radiation delivered before any subsequent surgical resection.\n\n* All types of radioligand therapy at any time prior to registration. Radioligands received for diagnostic purposes are not exclusionary.\n* Known hypersensitivity to somatostatin analogues or any component of the \\[68Ga\\]Ga- DOTATATE or \\[177Lu\\]Lu-DOTATATE formulations.\n* Active infection requiring current use of intravenous therapy with antibiotics.\n* Active cardiovascular disease: cerebral vascular accident/stroke (≤ 6 months prior to registration), myocardial infarction (≤ 6 months prior to registration), congestive heart failure (≥ NYHA class II), unstable angina pectoris, or serious cardiac arrhythmia requiring medication.\n* An active malignancy ≤ 3 years. Note: Patients with a malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Pregnant and/or breastfeeding patients who are unwilling to discontinue breast feeding.\n* Participants of childbearing potential must have a negative pregnancy test within 14 days of study entry.","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego - Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist MD Anderson Cancer Center","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Medical Group Oncology","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Health Care","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber/Harvard Cancer Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Rogel Cancer Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Lagone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sylvia C Kurz, MD,PhD","phone":"203-785-5616","email":"Sylvia.Kurz@yale.edu"}],"primaryOutcomes":["Progression Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["irvine-california","la-jolla-california","new-haven-connecticut","jacksonville-florida","miami-florida","tampa-florida","atlanta-georgia","indianapolis-indiana","iowa-city-iowa","boston-massachusetts","ann-arbor-michigan","detroit-michigan","new-york-new-york","durham-north-carolina","philadelphia-pennsylvania","houston-texas","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 2: testing [177Lu]Lu-DOTATATE for Intracranial Meningioma","inPlainEnglish":"This is an open-label, multicenter, randomly assigned, phase 2 clinical study to measure the how well it works of \\[177Lu\\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.","whoItsFor":["Ages 18 Years to any","STEP 1 REGISTRATION","Histologically confirmed diagnosis of WHO grade 1-3 meningioma","Disease progression following at least one prior surgical intervention (biopsy or resection) and at least one prior course of radiation","The patient is not considered a candidate for additional surgery and/or radiation or the patient has declined additional surgery and/or radiation","Progression of disease determined by local radiology review per current RANO meningioma criteria, defined as:","≥ 15% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 6 months (196 days), or","≥ 25% increase in sum of product of perpendicular measurements of up to 5 measurable target lesions within the last 12 months (379 days), or"],"whoShouldSkip":["Patients with a clinical diagnosis of NF2-related schwannomatosis or with a known molecular diagnosis of NF2-related schwannomatosis","Patients with radiation-associated meningiomas","Patients with known intraspinal meningiomas or meningioma metastases outside the skull/spinal column. Meningiomas invading the skull base or orbits are not excluded","Prior SSTR2-targeted therapy, e.g. Somatostatin LAR or short-acting Octreotide. No limit on number of prior non-SSTR2-tartgeted systemic therapies","Unstable neurological symptoms requiring steroids to control symptoms at a dose of \\>2 mg of dexamethasone (or equivalent) daily within 28 days prior to step 2 registration","Patients requiring immediate local therapy (e.g. surgical resection)","Surgical procedure within the timeframes listed below, prior to step 2 registration"],"whatHappens":"If you join, the listed intervention(s) are [177Lu]Lu-DOTATATE, or Standard of Care treatments. The registry lists allocation as randomized. This is an open-label, multicenter, randomly assigned, phase 2 clinical study to measure the how well it works of \\[177Lu\\]Lu-DOTATATE in patients with progressive grade 1-3 intracranial meningioma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 130 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:32.636Z"},{"nctId":"NCT06955221","title":"Effect of Alcohol Sclerotherapy on Pelvic Pain and Quality of Life in Women With Ovarian Endometriosis","officialTitle":"Effect of US-guided Alcohol Sclerotherapy for Endometriomas on Pelvic Pain and Quality of Life","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hospital Universitari de Bellvitge","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management.\n\nThe main questions it aims to answer are:\n\n1. \\- Does sclerotherapy significantly reduce pelvic pain compared to expectant management?\n2. \\- Does sclerotherapy improve quality of life as measured by the EHP-5 score?\n\nResearchers will compare the sclerotherapy group to the expectant management group to determine whether the intervention leads to greater improvement in pain and quality of life.\n\nParticipants will:\n\n* Be randomly assigned to one of two groups: (1) Sclerotherapy group: undergo ultrasound-guided puncture and alcohol sclerotherapy; (2) Control group: expectant management\n* Complete quality of life and pain assessments at baseline and after 6 months\n* Provide blood and urine samples for biomarker analysis (e.g., cortisol, IL-6, hsCRP, catecholamines)\n* Undergo ovarian reserve assessments (AMH, antral follicle count)\n* Be followed for adverse events, recurrence, fertility outcomes, and treatment-related costs\n\nThe study will follow an intention-to-treat and per-protocol analysis approach.","conditions":["Endometrioma","Ultrasound Therapy; Complications","Quality of Life","Pelvic Pain"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Ultrasound-guided aspiration and alcohol sclerotherapy"}],"enrollment":288,"startDate":"2025-01-01","completionDate":"2026-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female sex\n* Age ≥18 and ≤45 years\n* Ultrasound suspicion of unilocular endometrioma or with a thin septum less than 3 mm\n* Size between 30-100 mm, persistent for at least 3-6 months since diagnosis\n* Ca125 marker \\<300 UI/mL and HE4 \\< 70 pM\n* Signed informed consent\n\nExclusion Criteria:\n\n* Age \\<18 or \\>45 years\n* History of ovarian or uterine cancer\n* Endometrioma size \\<30 mm or \\>100 mm\n* Indication for surgical treatment of the endometrioma due to suspected severe extra-ovarian endometriosis or any other cause\n* Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy\n* Ca125 \\>300 UI/mL\n* HE4 \\>70 pM\n* Pregnant women\n* Patients who do not wish to participate in the study or who are mentally incapacitated","locations":[{"facility":"Hospital Universitario Son Espases","city":"Palma de Mallorca","state":"Balearic Islands","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consorci Sanitari de l'Anoia","city":"Igualada","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consorci Sanitari Integral","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Bellvitge","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital San Juan de Dios de Martorell","city":"Martorell","state":"Barcelona","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consorci Corporació Sanitària Parc Taulí","city":"Sabadell","state":"Barcelona","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Parc Sanitari Sant Joan de Deu","city":"Sant Boi de Llobregat","state":"Barcelona","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Viladecans","city":"Viladecans","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario San Pedro","city":"Logroño","state":"La Rioja","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital de la Vega Lorenzo Guirao","city":"Cieza","state":"Murcia","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Los Arcos del Mar Menor","city":"San Javier","state":"Murcia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Canarias","city":"San Cristóbal de La Laguna","state":"Santa Cruz De Tenerife","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Sant Joan de Reus","city":"Reus","state":"Tarragona","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital del Mar","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Sanabria","city":"Granada","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Jaén","city":"Jaén","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Arnau de Vilanova","city":"Lleida","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramón y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Joan XXIII","city":"Tarragona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consorcio Hospital General Universitario de València","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Recoletas Salud Campo Grande","city":"Valladolid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico Universitario Lozano Blesa","city":"Zaragoza","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Álava - Txagorritxu","city":"Vitoria-Gasteiz","state":"Álava","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amparo Garcia-Tejedor, MDPhD","phone":"34 + 932607695","email":"agarciat@bellvitgehospital.cat"}],"primaryOutcomes":["Quality of Life of patients with endometrioma"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["palma-de-mallorca-spain","badalona-spain","igualada-spain","lhospitalet-de-llobregat-spain","martorell-spain","sabadell-spain","sant-boi-de-llobregat-spain","viladecans-spain","logro-o-spain","cieza-spain","san-javier-spain","san-crist-bal-de-la-laguna-spain","reus-spain","barcelona-spain","granada-spain","ja-n-spain","lleida-spain","madrid-spain","tarragona-spain","valencia-spain","valladolid-spain","zaragoza-spain","vitoria-gasteiz-spain"],"enrichment":{"headline":"Not a traditional drug phase: Ultrasound-guided aspiration and alcohol sclerotherapy for Endometrioma","inPlainEnglish":"The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management. The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Age ≥18 and ≤45 years","Ultrasound suspicion of unilocular endometrioma or with a thin septum less than 3 mm","Size between 30-100 mm, persistent for at least 3-6 months since diagnosis","Ca125 marker \\<300 UI/mL and HE4 \\< 70 pM"],"whoShouldSkip":["Age \\<18 or \\>45 years","History of ovarian or uterine cancer","Endometrioma size \\<30 mm or \\>100 mm","Indication for surgical treatment of the endometrioma due to suspected severe extra-ovarian endometriosis or any other cause","Ultrasound suspicion of dermoid cysts, anechoic cysts, or cysts with high risk of malignancy","Patients who do not wish to participate in the study or who are mentally incapacitated"],"whatHappens":"If you join, the listed intervention(s) are Ultrasound-guided aspiration and alcohol sclerotherapy. The registry lists allocation as randomized. The goal of this clinical trial is to evaluate whether ultrasound-guided alcohol sclerotherapy can improve pelvic pain and quality of life in women aged 18 to 45 diagnosed with ovarian endometriomas, compared to expectant management.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 288 people at 26 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.107Z"},{"nctId":"NCT06955260","title":"SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure","officialTitle":"A Randomized Trial of SGLT2 Inhibition With Empagliflozin in Adults With Fontan Circulatory Failure (EMPA-HEART 3 CardioLink-12)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Subodh Verma","sponsorClass":"OTHER","summary":"Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life. FCF occurs when the single working heart ventricle is no longer strong enough to pump blood throughout the body. This also means the heart has difficulty supplying oxygen to keep up with the needs of the body. As a result, individuals living with FCF may have some challenges carrying out day to day activities. A heart transplant is currently the only therapeutic option for individuals living with FCF. The investigators are conducting this trial to determine whether a medication called empagliflozin can help these people have a better quality of life.","conditions":["Congenital Heart Disease"],"keywords":["Fontan Circulatory Failure","Empagliflozin","Double-blind","randomized"],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 mg"},{"type":"OTHER","name":"Placebo"}],"enrollment":410,"startDate":"2026-05-29","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out daily life activities, on standard of care therapy\n\nExclusion Criteria:\n\n* Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial\n* Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors\n* Pregnant or planning a pregnancy during the duration of the trial or breast feeding\n* Living with type 1 diabetes mellitus\n* Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis)\n* History of ketoacidosis\n* Has an estimated glomerular filtration rate (eGFR) that is \\<30 mL/min/1.73 m2 Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2-fold upper limit of normal (ULN) at screening\n* Has a baseline systolic BP that is \\<80 mmHg or ≥200 mmHg\n* Planned hospital intervention during trial period for management of FCF defined as one of the following:\n* Admission for intravenous diuretics\n* Admission for intravenous inotropes\n* Admission for ascites drainage\n* Admission for new or worsening ascites of clinical significance\n* Admission for management of arrhythmia\n* Admission for management of lymphatic dysfunction\n* Admission for interventional cardiological or cardiac surgical procedure within 30-days prior to screening, or consideration for any cardiac surgical or interventional cardiological procedure during trial participation\n* Admission for cardiac resynchronization therapy within 90-days prior to screening, or consideration of cardiac resynchronization therapy during trial participation\n* Is unable to provide written informed consent, complete the trial or comply with the requirements of the trial protocol\n* Participation in other interventional studies within 30-days of the screening visit that could influence any of the trial outcomes (exclusive of observational registries)\n* Received intravenous diuretic within the previous 14-days\n* On a heart transplant waiting list\n* Current or imminent hospitalization for management of FCF","locations":[{"facility":"St. Paul's Hospital","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicole Cooke, CCRP","phone":"416-864-6060","email":"Nicole.cooke@unityhealth.to"}],"primaryOutcomes":["Hierarchical endpoint"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["empagliflozin"],"locationSlugs":["vancouver-canada","toronto-canada"],"enrichment":{"headline":"Phase 3: testing Empagliflozin 10 mg for Congenital Heart Disease","inPlainEnglish":"Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart. This condition can be initially managed with a Fontan operation, but there is a risk of developing Fontan Circulatory Failure (FCF) later in life.","whoItsFor":["Ages 18 Years to any","Adults (≥18 years of age) with FCF, defined by dysfunction of the Fontan physiology that causes limitation to the individual's ability to carry out daily life activities, on standard of care therapy"],"whoShouldSkip":["Diuretic initiation or dose change ≤2 weeks prior to enrollment On a SGLT2 inhibitor currently or within 12-weeks prior to enrollment in the trial","Allergic to or has a known intolerance to any of the ingredients in empagliflozin or other SGLT2 inhibitors","Pregnant or planning a pregnancy during the duration of the trial or breast feeding","Living with type 1 diabetes mellitus","Has an unresolved acute illness (e.g., acute appendicitis, COVID-19, gastroenteritis)","History of ketoacidosis","Has an estimated glomerular filtration rate (eGFR) that is \\<30 mL/min/1.73 m2 Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2-fold upper limit of normal (ULN) at screening"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 mg, or Placebo. The registry lists allocation as randomized. Some people are born with a birth defect where they only have one functioning ventricle (lower chamber) in their heart.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 410 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.619Z"},{"nctId":"NCT06957418","title":"Alzheimer's Tau Platform: Master Protocol","officialTitle":"The Alzheimer's Disease Tau Platform Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Paul S. Aisen","sponsorClass":"OTHER","summary":"The goal of the Alzheimer's Tau Platform (ATP) is to evaluate the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.\n\nThis platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol. This means that multiple investigational products will be tested simultaneously or sequentially. Each investigational product will be tested in a regimen.\n\nThe main questions the platform trial aims to answer are:\n\n* Does a tau-directed therapy, alone or in combination with donanemab, reduce tau buildup in the brain compared to donanemab alone?\n* Does a tau-directed therapy, alone or in combination with donanemab, slow disease progression based on brain imaging, fluid biomarkers, and measures of memory and thinking?\n\nParticipants will:\n\n* Be randomized to a treatment regimens, each containing different tau therapies. The exact number of treatment regimens that will active at the time of screening will change over time.\n* Receive donanemab or placebo for 6 months, followed by 24 months of tau therapy alone or in combination with donanemab.\n* Undergo regular cognitive testing, brain scans (MRI/PET), and biomarker assessments over 30 months\n\nParticipants will have an equal chance to be randomized to all regimens that are active at the time of screening. Once randomized to a regimen, participants will be randomized to one of three arms: (1) tau therapy alone, (2) a combination of donanemab and tau therapy, or (3) donanemab alone.\n\nNew regimens will be continuously added as new investigational products become available. The Alzheimer's Tau Platform Trial will enroll additional participants as each new regimen becomes available.\n\nATP will launch with one regimen: Regimen A: AADvac1. In the future, Regimen B (\"Tau2\") will launch with a second tau directed therapy.","conditions":["Preclinical Alzheimer's Disease","Alzheimer Disease","Prodromal Alzheimer's Disease"],"keywords":["Alzheimer's disease","Preclinical Alzheimer's","Prodromal Alzheimer's","Mild cognitive impairment (MCI)","Neurodegeneration","Dementia","Tau-directed therapy","Monoclonal antibody","Anti-tau therapy","Combination therapy","Immunotherapy","anti-amyloid mAb"],"interventions":[{"type":"DRUG","name":"AADvac1"},{"type":"DRUG","name":"Tau2"}],"enrollment":900,"startDate":"2026-07-06","completionDate":"2028-08-31","sex":"ALL","minAge":"50 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Documentation of the participant's informed consent to study procedures (including APOE genotyping).\n2. Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \\<1.5\n3. Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \\<1.5).\n4. MMSE score at screening of 20-30 (inclusive) with educational adjustments:\n\n   1. If \\<12 years of education, MMSE required to be \\>20.\n   2. If 13 to 15 years (inclusive) of education, MMSE required to be \\>22.\n   3. If \\>16 years of education, MMSE required to be \\>24.\n5. Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD.\n6. Elevated brain tau on PET (MTL or NEO tau SUVr \\>1.2) at screening.\n7. Elevated brain amyloid on PET (centiloids \\> 40) at screening.\n8. Stable doses of permitted medications as described per protocol for a minimum of 30 days prior to screening.\n9. Resides at home or in the community (assisted living acceptable).\n10. In the opinion of the site PI, has a study partner able and willing to provide accurate information (including clinical symptoms and medical history) about the participant and participate in study visits and informant-based assessments (usually requires at least 5 hours of contact per week) for the duration of the study.\n11. As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures.\n12. Must complete all screening evaluations as outlined per protocol.\n\nExclusion Criteria:\n\n1. Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.\n2. Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use highly effective method of contraception for the duration of their participation in the study. Males who are sexually active with a female of childbearing potential and do not agree to use barrier methods of contraception (condoms with spermicide) during the trial and for 6 months after the last dose of study drug unless the female is using a highly effective method of contraception.\n3. Lacks good venous access such that multiple blood draws would be precluded.\n4. Weighs less than 40kg, or more than 136kg at screening.\n5. Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen.\n6. Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received placebo in the previous study.\n7. Prior or current treatment with a prohibited medication as described per protocol.\n8. Enrollment in another investigational study as described per protocol. Participants enrolled in an observational study may be permitted with Medical Monitor review and approval.\n9. Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.\n10. MRI scan at screening showing a single area of cerebral vasogenic edema, superficial siderosis, or showing more than four (4) cerebral microhemorrhages (defined as 10 mm or less at the greatest diameter); evidence of a prior or current macrohemorrhage (greater than 10 mm at greatest diameter, also referred to as intracerebral hemorrhage \\>1 cm within this protocol); cerebral contusion; encephalomalacia; aneurysms greater than 6 mm, or any aneurysms that have not been stable in size for the past 2 years; vascular malformations that are at high risk for hemorrhage; infectious lesions; evidence of multiple lacunar infarcts (that in the opinion of the investigator, may impact cognition); stroke involving a major vascular territory; severe small vessel disease; severe diffuse white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and less than 1 cm at their greatest diameter need not be exclusionary).\n11. Contraindications to tau and/or amyloid PET scan imaging and/or use of MK6240 and/or 18F-NAV-4694 (flutafuranol).\n12. For participants undergoing an LP as part of the optional longitudinal CSF biomarker sub-study, contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; international normalized ratio (INR) \\>1.4 or other coagulopathy; platelet count of \\<120,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of LP NOTE: low dose aspirin is permitted; degenerative arthritis of the lumbar spine; suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.\n13. Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of study drug (e.g., moderate and/or severe untreated obstructive sleep apnea, clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per the site PI's judgement.\n14. History of severe allergic reaction (e.g., anaphylaxis) including, but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.\n15. Hospitalization within 30 days prior to screening or baseline.\n16. Clinically significant infections or major surgical operation within 3 months prior to screening.\n17. History of chronic or recurrent infections judged to be clinically significant by the site PI and which would potentially hamper the evaluation of efficacy and safety assessments.\n18. Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, or significant coronary artery disease.\n19. History of cancer within the past 5 years other than treated squamous cell carcinoma, basal cell carcinoma and melanoma in-situ, in-situ prostate cancer, or in-situ breast cancer, which have been fully removed and are considered cured.\n20. History of inflammatory neurological disorders.\n21. History or presence of immunological or inflammatory conditions, including neurological disorders, judged to be clinically significant by the site PI.\n22. History of meningitis or meningoencephalitis.\n23. History of moderate or severe traumatic brain injury.\n24. History or presence of uncontrolled seizures. If history of seizures, they must be well controlled with no occurrence of seizures in the 2 years prior to study screening. The use of antiepileptic medications is permitted (see section 6.5.2).\n25. Concomitant or past history of psychiatric or neurologic disorder other than those considered to be related to AD (e.g., head injury with loss of consciousness, symptomatic stroke, Parkinson's disease, severe carotid occlusive disease, transient ischemic attacks, hemorrhagic and/or non-hemorrhagic stroke).\n26. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.\n27. Significant risk of suicide defined, using the C-SSRS, as the participant answering \"yes\" to suicidal ideation questions 4 or 5 or answering \"yes\" to suicidal behavior within the past 6 months.\n28. Clinically significant abnormal vital signs including sustained sitting blood pressure \\>160/90 mm Hg.\n29. Participants with diabetes mellitus with hemoglobin A1c (HbA1c) levels of \\>7.5%.\n30. In the opinion of the site PI, clinically significant deviations from normal values for hematologic parameters, liver function tests, and other biochemical measures, including, but not limited to:\n\n    1. hematocrit less than 35% for those with male biological sex and less than 32% for those with female biological sex.\n    2. absolute neutrophil cell count \\<1500/uL (with the exception of a chronic benign neutropenia).\n    3. absolute lymphocyte count \\<900/uL.\n    4. platelet cell count of \\<100,000/uL.\n    5. INR \\>1.4 or other coagulopathy, confirmed by repeat (not applicable for participants on anticoagulation).\n31. Participants with a known history of human immunodeficiency virus infection (HIV-1 and 2).\n32. Participants with known history of acute/chronic hepatitis B or C.\n33. Any other clinically significant, advanced, or unstable disease that may interfere with outcome evaluations, such as:\n\n    1. Chronic liver disease.\n    2. Respiratory insufficiency.\n    3. Renal insufficiency defined as estimated glomerular filtration rate (eGFR) \\<50 mL/min based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.\n    4. Bradycardia (\\<50/min) or tachycardia (\\>100/min). Bradycardia \\>40/min and \\<50/min may be permitted with review and approval by the Medical Monitor.\n34. Clinically significant arrhythmias or other clinically significant abnormalities on ECG at screening (minor abnormalities documented as clinically insignificant by the site PI are allowed).\n35. Any condition, which in the opinion of the site PI, Coordinating Center, or Project Lead/Protocol PI, makes the participant unsuitable for inclusion.","locations":[{"facility":"Banner Alzheimer's Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky Sanders Brown Center on Aging","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital Center for Alzheimer Research and Treatment","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Butler Hospital Memory and Aging Program","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harborview Medical Center, University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ATP Recruitment and Retention (RER) Team","phone":"213-821-0569","email":"adtau-participate@usc.edu"}],"primaryOutcomes":["Reduction of brain tau deposition as measured by tau positron emission tomography (PET)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["phoenix-arizona","san-francisco-california","lexington-kentucky","boston-massachusetts","providence-rhode-island","nashville-tennessee","seattle-washington"],"enrichment":{"headline":"Phase 2: testing AADvac1 for Preclinical Alzheimer's Disease","inPlainEnglish":"The goal of the Alzheimer's Tau Platform (ATP) is to measure the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease. This platform trial allows for the simultaneous testing of multiple tau therapies under a shared master protocol.","whoItsFor":["Ages 50 Years to 80 Years","Ages 50-80 years (inclusive). Participants between the ages of 50 and 60 (inclusive) must be mildly impaired at screening (global CDR=0.5 and maximum CDR-SB \\<1.5","Cognitively unimpaired (preclinical AD with a global CDR=0) or mildly impaired (prodromal AD with a global CDR=0.5 and maximum CDR-SB \\<1.5)","MMSE score at screening of 20-30 (inclusive) with educational adjustments:","If \\<12 years of education, MMSE required to be \\>20","If 13 to 15 years (inclusive) of education, MMSE required to be \\>22","If \\>16 years of education, MMSE required to be \\>24","Plasma biomarker result at screening that demonstrate the presence of amyloid pathology, consistent with preclinical-prodromal AD"],"whoShouldSkip":["Females who are lactating or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study","Lacks good venous access such that multiple blood draws would be precluded","Weighs less than 40kg, or more than 136kg at screening","Suspected or known allergic reactions, adverse reactions, or hypersensitivity to any components of the study intervention for any of the available regimen","Previous treatment with the study intervention from any available regimen unless it can be confirmed the participant received dummy treatment (placebo) in the previous study","Prior or current treatment with a prohibited medication as described per protocol","Enrollment in another investigational study as described per protocol. Participants enrolled in an watch-and-measure (no experimental treatment required) study may be permitted with Medical Monitor review and approval"],"whatHappens":"If you join, the listed intervention(s) are AADvac1, or Tau2. The registry lists allocation as randomized. The goal of the Alzheimer's Tau Platform (ATP) is to measure the safety and effectiveness of tau-directed therapies, alone or in combination with the anti-amyloid monoclonal antibody, donanemab, in adults aged 50-80 with late preclinical or early prodromal Alzheimer's disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 900 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.498Z"},{"nctId":"NCT06958536","title":"A Study to Investigate Efficacy and Safety of Brivekimig in Participants With Crohn's Disease","officialTitle":"A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of Brivekimig in Adults With Moderate to Severe Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a phase 2, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.","conditions":["Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"brivekimig"},{"type":"DRUG","name":"Placebo"}],"enrollment":99,"startDate":"2025-06-03","completionDate":"2026-12-17","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening\n* Confirmed diagnosis of moderate-to-severe CD\n* History of prior exposure to standard treatment and having inadequate response to, loss of response to or intolerance to standard therapy with any of the following compounds: (5-Amino Salicylates (5-ASAs), 6-Mercaptopurine (6-MP), Azathioprine (AZA), Methotrexate (MTX), oral or corticosteroids or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies\n* On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX, or Antibiotics, etc.)\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n\nExclusion Criteria:\n\n* Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome\n* Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement\n* Participants with following ongoing known complications of CD:\n\n  * Any manifestation that might require bowel surgery while enrolled in the study\n  * Participant with ostomy or ileoanal pouch\n  * Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome\n  * Participant with surgical bowel resection within the past three months prior to screening, or a history of \\>3 bowel resections\n* History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number: 8400026","city":"Fairhope","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400024","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400005","city":"Escondido","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400001","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400029","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400032","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400017","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400015","city":"Lighthouse PT","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number 8400028","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400012","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400007","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400011","city":"Palmetto Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400019","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400025","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400006","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400022","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400008","city":"Wyoming","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400013","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400003","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400009","city":"Harrisburg","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400002","city":"Fredericksburg","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400010","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400016","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400027","city":"Richmond","state":"Virginia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Investigational Site Number: 0360002","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0360004","city":"Kurralta Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0360001","city":"Footscray","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 0560001","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1560003","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1560008","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1560005","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1560001","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 1560006","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site 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2500001","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500003","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500004","city":"Saint-Priest-en-Jarez","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500002","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760002","city":"Minden","state":"Northwest","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760003","city":"Jena","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760004","city":"Kiel","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760001","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920007","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920005","city":"Ōita","state":"Oita Prefecture","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920006","city":"Hamamatsu","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920004","city":"Bunkyō City","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920003","city":"Hamamatsu","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920009","city":"Hirosaki","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920001","city":"Morioka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3920002","city":"Nishinomiya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160002","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160001","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160005","city":"Lublin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160006","city":"Sopot","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160008","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160003","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160010","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 6160004","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 7100001","city":"Cape Town","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site 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7240001","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 7240003","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260007","city":"Bury","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260004","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260009","city":"Dagenham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260005","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260002","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260001","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Percentage of participants who achieve endoscopic response at Week 16"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["fairhope-alabama","tucson-arizona","escondido-california","lancaster-california","san-diego-california","colorado-springs-colorado","kissimmee-florida","lighthouse-pt-florida","miami-florida","orlando-florida","palmetto-bay-florida","marietta-georgia","iowa-city-iowa","kansas-city-kansas","boston-massachusetts","wyoming-michigan","st-louis-missouri","chapel-hill-north-carolina","harrisburg-pennsylvania","fredericksburg-texas","houston-texas","ogden-utah","richmond-virginia","brisbane-australia","kurralta-park-australia","footscray-australia","leuven-belgium","changsha-china","changzhou-china","guangzhou-china","hangzhou-china","nanchang-china","shanghai-china","shenyang-china","brno-czechia","hradec-kr-lov-czechia","slan-czechia","montpellier-france","nice-france","saint-priest-en-jarez-france","toulouse-france","minden-germany","jena-germany","kiel-germany","ulm-germany","kashiwa-japan","ita-japan","hamamatsu-japan","bunky-city-japan","hirosaki-japan","morioka-japan","nishinomiya-japan","wroclaw-poland","krakow-poland","lublin-poland","sopot-poland","warsaw-poland","cape-town-south-africa","durban-south-africa","johannesburg-south-africa","plumstead-south-africa","barcelona-spain","madrid-spain","seville-spain","bury-united-kingdom","cambridge-united-kingdom","dagenham-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing brivekimig for Crohn's Disease","inPlainEnglish":"This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the how well it works of different doses of SAR442970 compared with dummy treatment (placebo) in participants with moderate to severe Crohn's disease.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening","Confirmed diagnosis of moderate-to-severe CD","On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, AZA, 6-MP, or MTX, or Antibiotics, etc.)","Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies"],"whoShouldSkip":["Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome","Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement","Participants with following ongoing known complications of CD:","Any manifestation that might require bowel surgery while enrolled in the study","Participant with ostomy or ileoanal pouch","Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome","Participant with surgical bowel resection within the past three months prior to screening, or a history of \\>3 bowel resections"],"whatHappens":"If you join, the listed intervention(s) are brivekimig, or Placebo. The registry lists allocation as randomized. This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, 3-arm study for the treatment of Crohn's disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 99 people at 78 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.900Z"},{"nctId":"NCT06959901","title":"PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents","officialTitle":"Investigating the Efficacy of Mobile Health Monitoring and Self-care to Improve Obesity Outcomes in Hispanic Adolescence Populations","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Baylor College of Medicine","sponsorClass":"OTHER","summary":"Hispanic adolescents in the U.S. are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population. Disparities in T2D are driven in part by independent, modifiable risk factors including low levels of physical activity, sleep, and poor diet. Lifestyle interventions are the cornerstone for maintaining glucose control and managing T2D. However, few studies have developed and tested lifestyle interventions for Hispanic youth with T2D. Digital health interventions that promote healthy lifestyle behaviors like physical activity, sleep, and diet, have demonstrated effectiveness among adults. Studies that use health-based smartphone applications have demonstrated preliminary efficacy for improving health-related lifestyle behaviors as these digital tools leverage behavior change techniques (e.g. self-monitoring, goal-setting, feedback) that have proven effective. Use of digital technology allows for the continuous delivery of intervention content into the home environment extending the reach of clinical care while engaging youth in a format that is age-appropriate given that today's youth are digital frontrunners. Unfortunately, while the use of digital health interventions have increased, few studies have focused on adolescents with overweight and obesity who are at high risk for T2D. The purpose of this study is to 1) develop a mobile health platform for remote and continuous monitoring of activity, sleep, and nutrition and 2) conduct a pilot study (30 days) to evaluate the efficacy of a novel digital health platform in improving obesity-related health outcomes outcomes in Hispanic adolescents (12-18 years; N=30) population.","conditions":["Obesity and Diabetes Mellitus, Type 2","Diabetes Prevention"],"keywords":["mHealth","Digital health","teen health","lifestyle intervention","mobile phone app"],"interventions":[{"type":"BEHAVIORAL","name":"PATHS-UP Mobile Phone Application"}],"enrollment":30,"startDate":"2025-04-30","completionDate":"2026-08-01","sex":"ALL","minAge":"12 Years","maxAge":"18 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* self-identify as Hispanic or Latino\n* 12-18 years\n* BMI% in the 85th-95th range,\n* Owns their own iphone\n\nExclusion Criteria:\n\n* Currently enrolled in a health program\n* Diagnosed with T2D\n* Present with a disease or condition that would prevent one from engaging in activity","locations":[{"facility":"Children's Nutrition Research Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pedro Garcia","phone":"(732)798-7092","email":"Pedro.Garcia@bcm.edu"}],"primaryOutcomes":["Rate of Recruitment","Feasibility of Technology","Usability","Acceptability","Acceptability"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: PATHS-UP Mobile Phone Application for Obesity and Diabetes Mellitus, Type 2","inPlainEnglish":"Are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs. 0.017%) contributing to higher rates of T2D-related vascular complications, cardiovascular disease, and mortality, among this population.","whoItsFor":["Ages 12 Years to 18 Years","self-identify as Hispanic or Latino","body-mass index (BMI)% in the 85th-95th range,","Owns their own iphone"],"whoShouldSkip":["Currently enrolled in a health program","Present with a disease or condition that would prevent one from engaging in activity"],"whatHappens":"If you join, the listed intervention(s) are PATHS-UP Mobile Phone Application. The registry lists allocation as na. Are disproportionately burdened by type 2 diabetes (T2D) compared to non-Hispanic white youth (0.079% vs.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Houston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.522Z"},{"nctId":"NCT06959979","title":"Novel Molecular Targets and Innovative Therapeutic Perspective in Medulloblastoma","officialTitle":"Novel Molecular Targets and Innovative Therapeutic Perspective in Medulloblastoma","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","sponsorClass":"OTHER","summary":"Medulloblastoma (MB), a rare yet critical pediatric brain tumor, is divided into 4 molecular subgroups (WNT, SHH, Group 3, Group 4), each with distinct genetic profiles. Despite diagnostic and therapeutic advances, neurotoxicity from standard treatments (resection, radiotherapy, chemotherapy) and the need for long-term care remain challenges. CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib), approved for breast cancer, show potential in other tumors, but their efficacy in MB is unclear. Treatment resistance is a concern. This project aims to identify genetic markers of sensitivity to CDK4/6 inhibitors in MB, to improve therapies and overcome resistance.","conditions":["Medulloblastoma, Childhood"],"keywords":[],"interventions":[{"type":"DRUG","name":"CDK4/6 Inhibitor (Palbociclib, Ribociclib, Abemaciclib)"}],"enrollment":60,"startDate":"2024-11-25","completionDate":"2026-08-31","sex":"ALL","minAge":"0 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* All patients affected by Medulloblastoma operated on at the Pediatric Neurosurgery Unit during their pediatric age will be elected to take part to the study","locations":[{"facility":"Fondazione Policlinico Gemelli Irccs","city":"Roma","state":"ROMA","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"GIANPIERO TAMBURRINI, MD","phone":"3349468776","email":"gianpiero.tamburrini@unicatt.it"},{"name":"MARIA CONCETTA GELOSO, PHD","phone":"","email":"mariaconcetta.geloso@unicatt.it"}],"primaryOutcomes":["Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6 inhibitors in medulloblastoma (MB).","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB.","Clarify the molecular mechanisms underlying the acquisition of resistance to CDK4/6i in MB."],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["roma-italy"],"enrichment":{"headline":"Early phase 1: testing CDK4/6 Inhibitor (Palbociclib, Ribociclib, Abemaciclib) for Medulloblastoma, Childhood","inPlainEnglish":"Medulloblastoma (MB), a rare yet critical pediatric brain tumor, is divided into 4 molecular subgroups (WNT, SHH, Group 3, Group 4), each with distinct genetic profiles. Despite diagnostic and therapeutic advances, neurotoxicity from standard treatments (resection, radiotherapy, chemotherapy) and the need for long-term care remain challenges.","whoItsFor":["Ages 0 Years to 18 Years","All patients affected by Medulloblastoma operated on at the Pediatric Neurosurgery Unit during their pediatric age will be elected to take part to the study"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are CDK4/6 Inhibitor (Palbociclib, Ribociclib, Abemaciclib). The registry lists allocation as randomized. Medulloblastoma (MB), a rare yet critical pediatric brain tumor, is divided into 4 molecular subgroups (WNT, SHH, Group 3, Group 4), each with distinct genetic profiles.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at Roma. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.729Z"},{"nctId":"NCT06962800","title":"A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)","officialTitle":"An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Biogen","sponsorClass":"INDUSTRY","summary":"In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys.\n\nKidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure.\n\nIn this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease.\n\nThe main question that researchers want to answer is:\n\n* How many participants achieve a complete response after 104 weeks of treatment?\n* A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable.\n\nResearchers will also learn about:\n\n* How long it takes before the participants' disease gets worse\n* How long the participants' urine protein levels stay low\n* How many participants develop antibodies against felzartamab in the blood?\n* How many participants achieve a complete response after 76 weeks of treatment\n* How many participants have medical problems during the study\n* How felzartamab is processed by the body\n* How felzartamab affects participants' tiredness and overall physical health\n\nThe study will be done as follows:\n\n* Participants will be screened to check if they can join the study. This may take up to 42 days.\n* Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets.\n* If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment.\n* If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104.\n* In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.","conditions":["Primary Membranous Nephropathy"],"keywords":[],"interventions":[{"type":"DRUG","name":"Felzartamab"},{"type":"DRUG","name":"Tacrolimus"},{"type":"DRUG","name":"Standard of Care IST"}],"enrollment":180,"startDate":"2025-05-22","completionDate":"2030-01-28","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) \\[see kidney biopsy exception below for participants positive for anti-PLA2R antibodies\\]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained, and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy.\n\n  a. Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies at Screening and have not had a kidney biopsy performed within 5 years of signing the ICF may be eligible for the study without undergoing a kidney biopsy based on medical monitor review of screening tests confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer ≥ 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes.\n* Meets one of the following:\n\n  1. Newly diagnosed PMN, defined as having never received IST for PMN in the past.\n  2. Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio \\[UPCR\\] ≥ 3.0 gram per gram \\[g/g\\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \\[g/24 h\\]).\n* Participants must be on the maximally approved dose or maximally tolerated dose of at least one renin-angiotensin-aldosterone system (RAAS) inhibition therapy (e.g. angiotensin-converting enzyme inhibitor \\[ACEI\\], angiotensin receptor blocker \\[ARB\\], and/or mineralocorticoid receptor antagonists \\[MRA\\]) for at least 4 weeks prior to Screening. Participants not on the maximally approved dose of RAAS inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). Participants on MRA therapy alone at Screening must have documented prior intolerance of ACEI or ARB therapy. 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3: testing Felzartamab for Primary Membranous Nephropathy","inPlainEnglish":"In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney.","whoItsFor":["Ages 18 Years to 80 Years","Meets one of the following:","Newly diagnosed PMN, defined as having never received IST for PMN in the past","A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 4 weeks prior to signing the ICF"],"whoShouldSkip":["Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \\[SLE\\], hepatitis B, hepatitis C, etc)","Severe renal impairment is defined as an eGFR ≤ 30 mL/min/1.73m\\^2 at Screening or including the need for dialysis or renal replacement therapy","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Felzartamab, Tacrolimus, or Standard of Care IST. The registry lists allocation as randomized. In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 180 people at 117 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.592Z"},{"nctId":"NCT06965452","title":"Trans-arterial Embolization for the Treatment of Facet Pain Due to Facet Arthropathy","officialTitle":"Trans Arterial Embolization for Facet 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arthropathy on MRI OR CT\n  * Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks.\n  * Failed medical management of pain.\n\n    * Back pain persistent for at least 6 months\n    * Pain worse than at least 6/10 on a visual analog pain scale\n  * Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure.\n  * Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1).\n  * Modified Rankin Scale 0-2\n\nExclusion Criteria:\n\n* \\- Pregnancy\n* History of prior spinal embolization at the target level.\n* History of surgery/ stenting of the aorta at the level of embolization.\n* Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)\n* Creatinine \\> 1.5 mg/dl and/or creatinine clearance \\< 60 mL/min (except if patients is already on hemodialysis).\n* Modified Rankin Scale \\>2\n* Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization.","locations":[{"facility":"North Shore University Hospital","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Betsy Moclair","phone":"516-253-7753","email":"bmoclair@northwell.edu"}],"primaryOutcomes":["Number of Procedure-Related Serious Adverse Events in the Perioperative Period"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["manhasset-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Spinal angiography and embolization/ Embozene Microspheres for Facet Joint Arthropathy","inPlainEnglish":"This single-site, single-arm study evaluates the feasibility, safety, tolerability, and how well it works of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.","whoItsFor":["Ages 18 Years to 85 Years","Confirmed diagnosis of spinal facet arthropathy on MRI OR CT","Confirmed diagnosis of lumbosacral facetogenic pain based on diagnostic nerve blocks","Failed medical management of pain","Back pain persistent for at least 6 months","Pain worse than at least 6/10 on a visual analog pain scale","Failed at least one of either intra-articular injections of steroids/ anesthetics or neuro-ablative procedure","Maximum of 2 spinal levels of facetogenic pain in the lumbar and sacral spine (i.e. L4-5 and L5-S1)"],"whoShouldSkip":["History of prior spinal embolization at the target level","History of surgery/ stenting of the aorta at the level of embolization","Severe allergic reaction to iodinated contrast (i.e. anaphylaxis)","Creatinine \\> 1.5 mg/dl and/or creatinine clearance \\< 60 mL/min (except if patients is already on hemodialysis)","Modified Rankin Scale \\>2","Angiographic/ Procedural Exclusion Criterion: Vascular supply to the spinal cord from the vessels supplying the facet joints targeted for embolization"],"whatHappens":"If you join, the listed intervention(s) are Spinal angiography and embolization/ Embozene Microspheres. The registry lists allocation as na. This single-site, single-arm study evaluates the feasibility, safety, tolerability, and how well it works of trans-arterial embolization (TAE) using Embozene microparticles for treating facetogenic pain due to facet arthropathy (osteoarthritis of the facet joints) in the lumbar spine.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Manhasset. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.524Z"},{"nctId":"NCT06966700","title":"A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)","officialTitle":"A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat types of breast cancer that are both:\n\n* High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment\n* Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.\n\nSacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread.\n\nThe main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy:\n\n* Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy\n* Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy","conditions":["Breast Neoplasms","Triple Negative Breast Neoplasms","HR Low-Positive/HER2-Negative Breast Neoplasms"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)"],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"Rescue Medication"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Doxorubicin"},{"type":"DRUG","name":"Epirubicin"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Olaparib"}],"enrollment":2400,"startDate":"2025-06-30","completionDate":"2033-03-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the physician investigator based on radiological and/or clinical assessment:\n\n  * cT1c, N1-N2\n  * cT2, N0-N2\n  * cT3, N0-N2\n  * cT4a-d, N0-N2\n* The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2- as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.\n* Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1).\n* Demonstrates adequate organ function.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement\n* Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer\n* Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before C1D1.\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137).\n* Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC).\n* Received prior treatment with a topoisomerase I inhibitor-containing ADC.\n* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Known additional malignancy that is progressing or has required active treatment within the past 5 years.\n* Uncontrolled systemic disease.\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..","locations":[{"facility":"Banner MD Anderson Cancer Center ( Site 0066)","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Cancer Center ( Site 0034)","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona Cancer Center ( Site 0035)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roy and Patricia Disney Family Cancer Center ( Site 0055)","city":"Burbank","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Cancer Institute ( Site 0100)","city":"Clovis","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation ( Site 0080)","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MemorialCare Health System - Long Beach Medical Center ( Site 9556)","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"El Camino Hospital Cancer Center ( Site 0096)","city":"Mountain View","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian ( Site 0010)","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helios Clinical Research ( Site 0061)","city":"Whittier","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health Cancer Center Saint Joseph ( Site 0062)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers (RMCC) ( Site 8006)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Health St. Mary's Regional Hospital ( Site 0054)","city":"Grand Junction","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)","city":"Altamonte Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - South ( Site 7004)","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partner ( Site 0072)","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital ( Site 0013)","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - North ( Site 7002)","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Cancer Center - Atlanta ( Site 0102)","city":"Newnan","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois Hospital Services ( Site 9554)","city":"Carterville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Wayne Medical Oncology and Hematology ( Site 0084)","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscan Health ( Site 0077)","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Clinic Foundation ( Site 0021)","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louisiana State University Health Sciences Shreveport ( Site 0053)","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Cancer Specialists ( Site 0051)","city":"Westbrook","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center - Baltimore ( Site 0015)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital Cancer Center ( Site 0091)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute ( Site 0090)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Cancer Institute ( Site 0059)","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University Siteman Cancer Center ( Site 0031)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Partners of Nebraska ( Site 0068)","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optum Care Cancer Center ( Site 0050)","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center ( Site 0041)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Univ Medical Center (HUMC) ( Site 0007)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey ( Site 0076)","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altru Health System ( Site 0057)","city":"Grand Forks","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Good Samaritan Hospital-TriHealth Cancer institute ( Site 0027)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Specialists (Compass Oncology) ( Site 8010)","city":"Tigard","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina-Hollings Cancer Center ( Site 0016)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Francis Cancer Center ( Site 0093)","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera McKennan Hospital ( Site 0002)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute - Yankton ( Site 0089)","city":"Yankton","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Cancer Specialists ( Site 7001)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 7005)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nashville General Hospital ( Site 0017)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt-Ingram Cancer Center ( Site 0038)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hendrick Medical Center ( Site 0009)","city":"Abilene","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8009)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern ( Site 0092)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas ( Site 8002)","city":"Flower Mound","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JPS Oncology and Infusion Center ( Site 0083)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kelsey-Seybold Clinic ( Site 0042)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kelsey-Seybold Clinic ( Site 0088)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants P.A. ( Site 0073)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Tech University Health Sciences Center ( Site 0087)","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - San Antonio ( Site 8004)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Medical Center ( Site 0074)","city":"Murray","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Cancer Institute at St. Francis ( Site 0048)","city":"Midlothian","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates (VOA) ( Site 8008)","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 8005)","city":"Roanoke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center ( Site 0069)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Northwest ( Site 0003)","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties, PLLC ( Site 0067)","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin-Madison ( Site 0024)","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clinicas Mar del Plata ( Site 6008)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires-ginecology ( Site 6003)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Educación Médica e Investigaciones clínicas \"Dr. Norberto Quirno\" (CEMIC) ( Site 6005)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Ars Medica ( Site 6004)","city":"San Salvador de Jujuy","state":"Jujuy Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque ( Site 6002)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 6006)","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Finochietto ( Site 6007)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Allende - Nueva Córdoba ( Site 6000)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio de la Cañada - Córdoba ( Site 6001)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chris O'Brien Lifehouse ( Site 1206)","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University ( Site 1203)","city":"North Ryde","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westmead Hospital ( Site 1200)","city":"Westmead","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Health ( Site 1201)","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman ( Site 3204)","city":"Liège","state":"Liege","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jessa Ziekenhuis ( Site 3200)","city":"Hasselt","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZORG Campus Aalst-Moorselbaan ( Site 3201)","city":"Aalst","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent ( Site 3202)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU UCL Namur/Site Sainte Elisabeth ( Site 3203)","city":"Namur","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"PRONUTRIR ( Site 6120)","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Araújo Jorge ( Site 6100)","city":"Goiânia","state":"Goiás","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Câncer ( Site 6111)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associação Hospitalar Beneficente São Vicente de Paulo ( Site 6115)","city":"Passo Fundo","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 6102)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital São Lucas da PUCRS ( Site 6103)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica de Oncologia Reichow ( Site 6112)","city":"Blumenau","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Pio XII - Hospital de Câncer de Barretos ( Site 6108)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Base de São José do Rio Preto ( Site 6101)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"INCA Hospital do Câncer III ( Site 6107)","city":"Rio de Janeiro","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Cancer - Surrey ( Site 0217)","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Cancer Vancouver ( Site 0218)","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"NL Health Services ( Site 0232)","city":"St. John's","state":"Newfoundland and Labrador","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Victoria Regional Health Centre ( Site 0233)","city":"Barrie","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Sciences North ( Site 0234)","city":"Greater Sudbury","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lakeridge Health ( Site 0225)","city":"Oshawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0209)","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sault Area Hospital ( Site 0226)","city":"Sault Ste. 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3: testing Sacituzumab tirumotecan for Breast Neoplasms","inPlainEnglish":"Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory","Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before Cycle1 Day 1 (C1D1)","Demonstrates adequate organ function"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Pembrolizumab, or Rescue Medication. The registry lists allocation as randomized. Researchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,400 people at 335 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.948Z"},{"nctId":"NCT06967857","title":"Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression","officialTitle":"Randomized, Placebo-controlled Clinical Trial to Investigate the Safety and Efficacy of Two Dexamfetamine Sulfate Formulations in Adults With ADHD and Moderate to Severe Depression (DEXAD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Prof. Dr. Frank Behrens","sponsorClass":"OTHER","summary":"The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD. The prevalence of comorbid depression in adults with ADHD is estimated to be as high as 50%.\n\nThere is evidence that stimulants such as dexamfetamine and methylphenidate lead to an improvement in sustained focused attention, working memory, and a variety of cognitive processes in the prefrontal cortex (PFC). In combination with the pharmacological effects of stimulants, such as the inhibition of monoamine oxidase, the increase in the concentration of noradrenaline in the PFC and dopamine in the striatum, dexamfetamine and methylphenidate could improve the treatment of depression in patients with major depressive disorder and comorbid ADHD.\n\nThis clinical trial will evaluate the safety and efficacy of DEX in two different formulations compared to placebo in adults with ADHD and moderate to severe depression. To ensure double blinding of the treatment, placebo will be administered in the form of tablets and capsules.","conditions":["Attention-Deficit/Hyperactivity Disorder (ADHD)","Depression - Major Depressive Disorder"],"keywords":["ADHD","Depression","Adults"],"interventions":[{"type":"DRUG","name":"DEX IR tablets"},{"type":"DRUG","name":"DEX XL"},{"type":"DRUG","name":"Placebo"}],"enrollment":105,"startDate":"2025-05-15","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of attention deficit / hyperactivity disorder (ADHD) (according to DSM-5 (fifth version of Diagnostic and Statistical Manual of Mental Disorders) or ICD (International Statistical Classification Of Diseases And Related Health Problems) guidelines) which started in childhood (at the age of \\<12 years)\n2. Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0)\n3. Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of \\>20 at baseline (V0)\n4. CGI-S ≥ 4 at baseline (V0)\n5. Patients receiving selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the last 2 weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mg venlafaxine extended release)\n6. Male or female patients ≥ 18 years and ≤ 65 at time of enrolment\n7. Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)\n8. Patient is either free of stimulant medication or who, after discussion with his / her treating physician, is able and willing to discontinue the current psychotropic medication(s) for treatment of ADHD symptoms (specifically, methylphenidate, lisdexamfetamine, guanfacine or atomoxetine or any other medication approved for the treatment of ADHD) ) for the duration of the study, as well as is able and willing to discontinue all relevant co-medication according to exclusion criterion no. 20a-s for comorbid conditions during the clinical trial, if applicable\n9. Written informed consent and data protection declaration obtained prior to the initiation of any protocol required procedures\n10. Willing and able to comply to study procedures and study protocol\n\nExclusion Criteria:\n\n1. Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes\n2. Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry\n3. Patients with body mass index (BMI) \\< 18.5 kg/m² or \\>35 kg/m²\n4. History of serotonin syndrome events\n5. History of seizures or use of anticonvulsant medication\n6. Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation\n7. Known symptomatic cardiovascular disease including structural abnormalities, moderate and severe hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pressure ≥100 mmHg), heart failure, myocardial infarction, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, potentially life-threatening arrhythmias and channelopathies (diseases caused by ion channel dysfunction)\n8. Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder\n9. Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma or porphyria\n10. Diagnosis or family history of Tourette's syndrome or dystonia\n11. Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke\n12. Immunodeficiency disorders (e.g. organ transplantation, Human Immunodeficiency Virus (HIV) infection)\n13. Known hypersensitivity to any of the ingredients of the trial medication, e.g. patients with known rare hereditary problems of fructose intolerance\n14. Males or females of reproductive potential not willing to use effective contraception (defined as PEARL index \\<1 - e.g. contraceptive pill, intrauterine device (IUD)) during the study period (Screening to Follow-up)\n15. Pregnancy and lactation\n16. Participation in another interventional clinical trial during the trial and within the previous 30 days prior to trial start\n17. Patients who are institutionalised by court order or regulatory action\n18. Patients, who are members of the staff of the trial centre, staff of the sponsor or involved Clinical Research Organisation (CRO), the investigator him- / herself or close relatives of the investigator\n19. Legal incapacity and/ or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the clinical trial\n20. Current use of and use within the last 2 weeks before inclusion due to possible interactions with stimulants or SSRIs/SNRIs and possible resulting or expected side effects:\n\n    1. Antipsychotics (such as chlorpromazine, haloperidol, thioridazine; except for quetiapine up to 100mg/day)\n    2. SSRIs and SNRIs daily doses of \\>40 mg (es)citalopram, \\>200 mg sertraline, \\>300 mg venlafaxine extended release\n    3. Monoamine oxidase inhibitors (MAO) inhibitors\n    4. tricyclic antidepressants\n    5. benzodiazepines (including Z-drugs)\n    6. atypical antidepressants (with an exception for daily doses of 100-300 mg trazodone)\n    7. Dopamine reuptake inhibitors (special restriction for bupropion)\n    8. antiarrhythmics (Class IA and III)\n    9. antibiotics (in particular macrolides and fluoroquinolones, linezolid)\n    10. opioids\n    11. hydroxychloroquine, chloroquine\n    12. ketoconazole\n    13. acetylsalicylic acid (dose up to 300 mg allowed)\n    14. diphenhydramine\n    15. apixaban\n    16. metoprolol\n    17. pregabalin\n    18. budesonide / formoterol\n    19. albuterol / salbutamol","locations":[{"facility":"Charité - Universitätsmedizin Berlin Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Bonn AöR, Klinik und Poliklinik für Psychiatrie und Psychotherapie","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Psychiatry, Psychosomatics and Psychotherapy University Hospital Frankfurt am Main - Goethe University","city":"Frankfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Leipzig, Department of Psychiatry and Psychotherapy","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"LMU Klinikum München Klinik für Psychiatrie und Psychotherapie","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christin Jonetzko","phone":"+49 69 630180210","email":"christin.jonetzko@itmp.fraunhofer.de"},{"name":"Anja Kuehne","phone":"","email":"anja.kuehne@itmp.fraunhofer.de"}],"primaryOutcomes":["Incidence of adverse events (AE) in the active treatment groups compared to the placebo until V6"],"hasResults":false,"conditionSlugs":["depression","adhd"],"drugSlugs":[],"locationSlugs":["berlin-germany","bonn-germany","frankfurt-germany","leipzig-germany","m-nchen-germany"],"enrichment":{"headline":"Phase 2: testing DEX IR tablets for Attention-Deficit/Hyperactivity Disorder (ADHD)","inPlainEnglish":"The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives. Depression is one of the most common comorbidities in patients with ADHD.","whoItsFor":["Ages 18 Years to 65 Years","Patient has a minimum ADHS-Diagnostische Checkliste-Q (ADHS-DC) total score of 32 at baseline (Visit (V) 0)","Moderate to severe depression according to ICD-10 (depressive episode: Code F32; recurrent depressive disorder: Code F33) and with a Montgomery-Åsberg Depression Rating Scale (MADRS) score of \\>20 at baseline (V0)","CGI-S ≥ 4 at baseline (V0)","Patients receiving selective serotonin reuptake inhibitors (SSRIs) or Serotonin-norepinephrine reuptake inhibitors (SNRIs) (stable doses within the last 2 weeks before inclusion) (≤40 mg (es)citalopram, 50-200 mg sertraline, 75 - 300 mg venlafaxine extended release)","Male or female patients ≥ 18 years and ≤ 65 at time of enrolment","Patients with QTc interval within normal ranges (≤470 ms in males and ≤480 ms in females)","Willing and able to comply to study procedures and study protocol"],"whoShouldSkip":["Current or a history of severe co-morbid symptoms such as psychotic symptoms, schizophrenia, bipolar disorders or manic episodes","Current or recent history of substance abuse disorder within the last 6 months of clinical trial entry","Patients with body mass index (body-mass index (BMI)) \\< 18.5 kg/m² or \\>35 kg/m²","History of serotonin syndrome events","History of seizures or use of anticonvulsant medication","Any other uncontrolled psychiatric condition that requires medication or may interfere with trial participation","Significant, in the discretion of the investigator, hepatic, gastrointestinal, renal, haematological or oncologic disorder"],"whatHappens":"If you join, the listed intervention(s) are DEX IR tablets, DEX XL, or Placebo. The registry lists allocation as randomized. The indication of attention-deficit/hyperactivity disorder (ADHD) to be examined often occurs with other psychiatric disorders, and the majority of adults with ADHD have at least one psychiatric comorbidity in their lives.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 105 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.658Z"},{"nctId":"NCT06969170","title":"Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","officialTitle":"A Phase 2a, Placebo-Controlled Randomized, Double-Blind Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Psilocybin Oral Solution in Adults With Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"QUADRUPLE","sponsor":"Claudio N Soares","sponsorClass":"OTHER","summary":"This Phase 2a clinical trial is designed to evaluate the safety, tolerability, and preliminary efficacy of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD).\n\nThe study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), Double-blind Treatment Phase (4 weeks)\n\nScreening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility. To qualify, patients must have a clinician-rated Hamilton Anxiety Rating Scale (HAM-A) score ≥14. Additionally, participants must not be on regular anxiolytic treatment or must have discontinued such treatment at least 4 weeks prior to the start of the Open-label Run-in Phase.\n\nOpen-label Run-in Phase Eligible patients will proceed to the 4-week Open-label Run-in Phase. During this phase, patients will attend four weekly clinic visits, supplemented by weekly remote contacts (via phone or email).\n\nAt different timepoints during the OL Run-in Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nDouble-blind Treatment Phase Participants who demonstrate a treatment response during the Open-label Phase-defined as a ≥50% reduction in GAD-7 score from baseline-will be randomized 1:1 to receive either psilocybin oral solution or placebo at the Double-blind Baseline Visit. Patients not meeting the response criteria will undergo End-of-Treatment (ET) procedures at this visit.\n\nAt different timepoints during the DB Treatment Phase, participants will complete safety assessments, undergo cognitive testing and EEG and other patient reported outcomes (PROs).\n\nCompletion of the End of Treatment (ET) phase will be 2 weeks to further assess safety and PROs.","conditions":["Generalized Anxiety Disorder (GAD)"],"keywords":["Psilocybin","Double-Blind","Psychedelic","Generalized Anxiety Disorder"],"interventions":[{"type":"DRUG","name":"Psilocybin (drug)"},{"type":"OTHER","name":"Placebo"}],"enrollment":50,"startDate":"2025-05-16","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Must provide written informed consent prior to the initiation of any protocol-specific procedures.\n2. Male and female adults, between 18 and 60 years of age, inclusive.\n3. Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI.\n4. Clinician-rated GAD-7 score ≥14 at Screening (Visit 1).\n5. Clinician-rated HAM-A score ≥14 at Screening (Visit1).\n6. Females must be non-pregnant and non-lactating and must fulfil at least one of the following:\n\n   * Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization).\n   * Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test).\n   * Agree to avoid pregnancy and use a medically acceptable method of contraception with male sexual partners from at least 30 days prior to the study until 30 days after the study has ended (last study procedure).\n   * Medically acceptable methods of contraception include any of the following:\n   * Double-barrier methods (e.g., male condom, spermicide with diaphragm or spermicide with cervical cap)\n   * Oral contraceptives; hormonal patch, implant or injection; or hormonal or non-hormonal intrauterine device. The male partner should use, at all times, a male condom with spermicide, should the female Patient choose to use any of these methods\n   * Complete abstinence, should it be in line with the Patient's preferred and usual lifestyle.\n7. Males who are able to father children must agree to use medically acceptable methods of contraception during the study and for 30 days after the last study drug administration. If a patient's partner should become pregnant during his participation in the study and for 30 days after he has completed his last study drug administration, the patient must inform study staff immediately. Medically acceptable methods of contraception include:\n\n   * Using a condom with a female partner of child-bearing potential who is using oral contraceptives; hormonal patch, implant or injection; hormonal or non-hormonal intrauterine device; or diaphragm or cervical cap with spermicide\n   * Complete abstinence, should it be in line with the patient's preferred and usual lifestyle.\n8. Males must refrain from sperm donation from clinic admission to at least 30 days after the last dose of study drug.\n9. Must be able to speak, read, and understand English sufficiently to allow completion of all study assessments.\n10. Must be willing to comply with the requirements and restrictions of the study.\n\nExclusion Criteria:\n\n1. Personal history of schizophrenia, bipolar affective disorder, delusional disorder, paranoid disorder, moderate or severe panic disorder, moderate or severe social anxiety disorder, schizoaffective disorder, moderate or severe obsessive-compulsive disorder, anorexia nervosa, bulimia nervosa, moderate or severe post-traumatic stress disorder (as assessed by the IES-R), moderate or severe personality disorder (Cluster B and Cluster C only), moderate or severe MDD (as assessed by the MINI and total scores on the MADRS \\> 19).\n2. History or presence of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, renal, or other disease at Screening, which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results.\n3. Recently initiated non-pharmacological treatment (e.g., Cognitive Behavioral Therapy, psychotherapy) with a psychologist or health care professional (i.e., \\<4 weeks prior to Screening). Patients who began a stable non-pharmacological treatment regimen \\>4 weeks prior to Screening will be permitted. Patients currently stable on treatment will not be permitted to modify or introduce new elements to their existing treatment regimen while enrolled in the study.\n4. Currently taking pharmacological treatment for GAD or depressive symptoms on a daily basis as outlined in Table 2. Patients who discontinue pharmacological treatment within a minimum of 4 weeks or more of baseline will be permitted to enroll in the study. Sporadic, prn use of anxiolytics will be permitted; however, patients will be required to document all medication use prior to study enrollment (See Section 9.7).\n5. Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \\>440 milliseconds in males and \\>460 milliseconds in females.\n6. History of allergies to the investigational product or excipients.\n7. History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies.\n8. Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.\n9. Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g/day or 3g/week;\n\n   \\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency/amount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms.\n10. Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation).\n11. Has used CNS drugs with perception-altering properties (e.g., ketamine, lysergic acid diethylamide \\[LSD\\], phencyclidine \\[PCP\\], 3,4 methylenedioxymethamphetamine \\[MDMA\\], mescaline, psilocybin, tryptamine derivatives, or ring-substituted amphetamines with perception-altering effects) on more than 1 occasion for therapeutic or non-therapeutic purposes (i.e., for psychoactive effects) within the past 6 months. History of single or episodic use will not be considered exclusionary.\n12. History of suicidal ideation in the past 12 months or active/current suicidality, based on C-SSRS results.\n13. Is currently using an investigational drug or device or has used such in the 30 days prior to receiving study drug.\n14. Female patient is pregnant or breastfeeding.\n15. Patient, in the investigator's opinion, is unsuitable for clinical study participation.\n\nCriteria for Randomization into the Double-Blind Treatment Phase\n\n1\\. Minimum 50% reduction in GAD-7 score from Open-Label Baseline Visit (Visit 1) to Double-Blind Baseline Visit","locations":[{"facility":"Kingston General Health Research Institute","city":"Kingston","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Claudio N Soares, MD, PhD, FRCPC, MBA","phone":"1-613-548-3232","email":"claudio.soares@kingstonhsc.ca"}],"primaryOutcomes":["To assess the safety and tolerability of psilocybin"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":["psilocybin"],"locationSlugs":["kingston-canada"],"enrichment":{"headline":"Phase 2: testing Psilocybin (drug) for Generalized Anxiety Disorder (GAD)","inPlainEnglish":"This Phase 2a clinical trial is designed to measure the safety, tolerability, and preliminary how well it works of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD). The study consists of three sequential phases: Screening Phase (up to 4 weeks), Open-label Run-in Phase (4 weeks), neither you nor the study doctors know who gets the real treatment Treatment Phase (4 weeks) Screening Phase During the Screening Visit, participants will provide informed consent and undergo a comprehensive medical evaluation, including an abbreviated psychiatric assessment, to determine eligibility.","whoItsFor":["Ages 18 Years to 60 Years","Male and female adults, between 18 and 60 years of age, inclusive","Meets DSM-V criteria for a primary diagnosis of GAD at Screening (duration of diagnosis ≥1 year, based on self-report), confirmed using the MINI","Clinician-rated GAD-7 score ≥14 at Screening (Visit 1)","Clinician-rated HAM-A score ≥14 at Screening (Visit1)","Females must be non-pregnant and non-lactating and must fulfil at least one of the following:","Be surgically sterile for a minimum of 6 months (achieved through hysterectomy, oophorectomy, or bilateral salpingectomy; note that tubal ligation is not considered a method of permanent sterilization)","Post-menopausal for a minimum of 1 year (confirmed by follicle-stimulating hormone test)"],"whoShouldSkip":["Clinically significant abnormality on ECG, including a QT interval corrected for heart rate (Bazett; QTcB interval) of \\>440 milliseconds in males and \\>460 milliseconds in females","History of allergies to the investigational product or excipients","History of seizures, family history of seizures, history of head trauma, history of neurosurgery, or close family history of idiopathic generalized epilepsy or other congenital epilepsies","Positive for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody","Positive urine drug screen at Screening , inclusive of cannabis use at a rate above 0.5g/day or 3g/week;","\\- Abstinence commitment clause: Patients who use cannabis at below or up to the frequency/amount listed above may be allowed to participate if they are willing and able to discontinue use for the duration of the study period without experiencing withdrawal symptoms","Current or history of moderate or severe drug or alcohol use disorder (excluding caffeine and nicotine) within the past 2 years, or lifetime history of participation in a drug rehabilitation program (other than treatment for smoking cessation)"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (drug), or Placebo. The registry lists allocation as randomized. This Phase 2a clinical trial is designed to measure the safety, tolerability, and preliminary how well it works of a 3 mg dose of psilocybin oral solution for the treatment of Generalized Anxiety Disorder (GAD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Kingston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.356Z"},{"nctId":"NCT06971380","title":"Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis","officialTitle":"A Phase 2 Trial to Study Efficacy and Safety of HBI0101 (NXC-201) CART in Subjects With Multiple Myeloma and Light-Chain Amyloidosis.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Polina Stepensky","sponsorClass":"OTHER","summary":"A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to evaluate the efficacy and safety of HBI0101 CART.","conditions":["Multiple Myeloma, Refractory to Standard Treatment","Multiple Myeloma, Relapsed","Light Chain Amyloidosis"],"keywords":["Relapsed/Refractory Multiple Myeloma","Light-Chain Amyloidosis","B-cell maturation antigen (BCMA)","Autologous CAR-T"],"interventions":[{"type":"BIOLOGICAL","name":"HBI0101 CART"}],"enrollment":180,"startDate":"2025-03-01","completionDate":"2028-05-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ≥18 years of age at the time of signing informed consent.\n2. Voluntarily signed informed consent form.\n3. Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit\n4. Subject suffering from multiple myeloma must have been exposed to at least two prior lines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy or anti-CD38 antibody, or functionally high-risk patients (i.e. first relapse within 18 months of treatment initiation) may be included.\n\n   Subject with amyloidosis must have been exposed to at least one prior line of therapy which includes proteasome inhibitor or anti-CD38 antibody, or subjects with insufficient response (i.e. not achieving a VGPR or CR after exposure to at least an anti-CD38 antibody and a proteasome inhibitor) may be included.\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.\n6. Women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months, must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n7. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy.\n8. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n9. Subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study.\n\nExclusion Criteria:\n\n1. Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures.\n2. Known bulky central nervous system disease.\n3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 4x ULN.\n4. Inadequate renal function defined by serum creatinine clearance/estimated clearance of \\<20(ml/min).\n5. International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an exclusion criteria).\n6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) \\< 1000 cells/mm\\^3, platelet count \\< 30,000 mm\\^3, or hemoglobin \\< 8 g/dL. Subjects with absolute lymphocyte count \\< 300 cells/mm\\^3 may be excluded (due to potential challenges with producing CART cells), per investigator judgement.\n7. Echocardiogram with left ventricular ejection fraction \\< 40%.\n8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemic steroids (physiological replacement doses of steroids are allowed up to 12 mg/m\\^2/d hydrocortisone or equivalent)\n9. Significant co-morbid condition or disease which in the judgment of the Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, recent significant traumatic injury, and other conditions.\n10. Known human immunodeficiency virus (HIV) positive status.\n11. Active Hepatitis B or Hepatitis C active infection.\n12. Active CMV infection.\n13. Known history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within 3 months.\n14. Chronic atrial fibrillation with uncontrolled heart rate.\n15. Second primary malignancies that has required therapy in the last 2 years or is not in complete remission.\n16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism or deep vein thrombosis) requiring anticoagulation and who meet any of the following criteria:\n\n    1. Have been on a stable dose of anticoagulation for \\< 1 month (except for acute line insertion induced thrombosis.)\n    2. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days\n    3. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).\n17. Pregnant or lactating women.\n18. Participation in another interventional clinical trial within 30 days prior to screening visit.","locations":[{"facility":"Hadassah MO","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Polina Stepensky, MD","phone":"972-2-6778353","email":"Fainak@hadassah.org.il"}],"primaryOutcomes":["Clinical response to HBI0101 CART"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":["car-t"],"locationSlugs":["jerusalem-israel"],"enrichment":{"headline":"Phase 2: testing HBI0101 CART for Multiple Myeloma, Refractory to Standard Treatment","inPlainEnglish":"A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients. The goal of the study is to measure the how well it works and safety of HBI0101 CART.","whoItsFor":["Ages 18 Years to any","Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed or refractory disease, with measurable disease at screening visit","Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2","Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 3 neuropathy","Ability and willingness to adhere to the study visit schedule and all protocol requirements","Subjects with relapsed multiple myeloma who have previously undergone allogenic stem cell transplantation must have no evidence of graft versus host disease after cessation of any immunosuppressive therapy for at least one month before recruitment to the study"],"whoShouldSkip":["Contraindication to a study treatment/procedure or is anticipated to receive treatment/procedure that may preclude performance of study procedures","Known bulky central nervous system disease","Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \\> 2.5 x upper limit of normal (ULN) and direct bilirubin \\> 4x ULN","Inadequate renal function defined by serum creatinine clearance/estimated clearance of \\<20(ml/min)","International ratio (INR) or partial thromboplastin time (PTT) \\> 2 x ULN, unless on a stable dose of anticoagulant for a thromboembolic event (provided this event is not an"],"whatHappens":"If you join, the listed intervention(s) are HBI0101 CART. The registry lists allocation as na. A Phase II study of HBI0101 (NXC-201) BCMA-CART in Multiple Myeloma and Light-chain Amyloidosis Patients.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at Jerusalem. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.505Z"},{"nctId":"NCT06972056","title":"Comparative Effectiveness of Migraine Preventive Medications: The APT Comparison Study","officialTitle":"A Comparative Effectiveness Study of Oral Medications Used for Migraine Prevention: The APT Comparison Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This goal of this study is to compare three medications used for migraine preventive treatment.\n\nThis study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol. It will be determined if one works better and is more tolerable than the others.\n\nResearch participants will:\n\n* Be randomly assigned to one of the three medications.\n* Provide information about their migraine pattern using a daily headache diary and during research visits.","conditions":["Migraine"],"keywords":["Migraine","Migraine with aura","Migraine prevention"],"interventions":[{"type":"DRUG","name":"Atogepant 60 mg"},{"type":"DRUG","name":"Propranolol 160 mg"},{"type":"DRUG","name":"Topiramate 100 mg"}],"enrollment":1335,"startDate":"2025-07-09","completionDate":"2029-03-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults, 18-70 years of age at the time of enrollment\n* Migraine with aura, migraine without aura, and/or chronic migraine; according to ICHD-3 diagnostic criteria. (Those with daily or continuous headaches are not excluded.)\n* Migraine onset prior to 50 years of age\n* Migraine present for at least 12 months at the time of enrollment\n* At least four \"moderate to severe headache days\" per month (by patient self-report and then confirmed during four-week pre-randomization headache diary phase) A \"moderate to severe headache day\" is defined as a day during which there is a headache of moderate to severe intensity that lasts for at least four hours, or a day on which a migraine-specific acute medication is taken to treat headache.\n* If already taking a migraine preventive treatment, willing to continue with that treatment without dose change during the first 16 weeks of the study, including the 4-week run-in phase and 12-week randomized phase.\n* Not pregnant or breastfeeding\n* Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy.\n* Willingness and ability to provide informed consent.\n* Willingness and ability to complete all research visits.\n\nExclusion Criteria:\n\n* Contraindications to taking atogepant, propranolol, or topiramate.\n* Currently taking atogepant, propranolol, or topiramate\\*\n* Previously took atogepant, propranolol, or topiramate\\*\n* Unwillingness to take atogepant, topiramate, or propranolol.\n* Current use of a CGRP-targeting preventive medication or beta-blocker\n* Migraine with brainstem aura\n* Hemiplegic migraine\n* Retinal migraine\n* Migraine aura without headache (exclusively)\n* Pure menstrual migraine\n* Trigeminal autonomic cephalalgias\n* Facial neuralgias\n* Secondary headache disorders (medication overuse headache is not an exclusion)\n* Migraine preventive treatment has been started or dose has been changed within 12 weeks prior to potential enrollment.\n* Used opioids or butalbital on five or more days per month on average for at least 3 months prior to enrollment.\n* Current or past epilepsy\n* Severe hepatic impairment\n* Moderate or more severe renal impairment \\* Occasional as needed use of propranolol, currently or in the past, is not an exclusion, such as taking as needed propranolol for treatment of anxiety.","locations":[{"facility":"Apogee Clinical Research","city":"Hazel Green","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northern Arizona Healthcare","city":"Flagstaff","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck School of Medicine of USC","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Desert Physicians Medical Group","city":"Palm Springs","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Neurology Group","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Healthcare","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Apple Med Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuroscience Research Center","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials of New England","city":"Hyde Park","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University St Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute Reno","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JFK Neuroscience Institute","city":"Edison","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nuvance Health Institute","city":"Kingston","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mt Sinai Icahn School of Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions Park Cedar Dr.","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions Mecklenburg","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions Ballantyne","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Onsite Clinical Solutions Salisbury","city":"Salisbury","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Health","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brown University Health","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DHR Health Headache Center","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute Ogden","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinic Research Institute","city":"Marshfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael R Leonard, MDiv","phone":"480-342-2908","email":"ARZAPTTrial@mayo.edu"},{"name":"Dani C Smith, M.S.","phone":"","email":"Smith.Dani@Mayo.edu"}],"primaryOutcomes":["Treatment Responder (atogepant vs. topiramate; atogepant vs. propranolol)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["hazel-green-alabama","flagstaff-arizona","phoenix-arizona","los-angeles-california","palm-springs-california","pomona-california","aurora-colorado","hollywood-florida","jacksonville-florida","miami-florida","overland-park-kansas","hyde-park-massachusetts","rochester-minnesota","st-louis-missouri","omaha-nebraska","reno-nevada","edison-new-jersey","kingston-new-york","manhasset-new-york","new-york-new-york","charlotte-north-carolina","salisbury-north-carolina","winston-salem-north-carolina","columbus-ohio","portland-oregon","philadelphia-pennsylvania","providence-rhode-island","nashville-tennessee","mcallen-texas","ogden-utah","morgantown-west-virginia","marshfield-wisconsin","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 4: testing Atogepant 60 mg for Migraine","inPlainEnglish":"This goal of this study is to compare three medications used for migraine preventive treatment. This study will compare atogepant, a newer migraine preventive medication, with two older preventive medications, topiramate and propranolol.","whoItsFor":["Ages 18 Years to 70 Years","Adults, 18-70 years of age at the time of enrollment","Migraine with aura, migraine without aura, and/or chronic migraine; according to ICHD-3 diagnostic criteria. (Those with daily or continuous headaches are not excluded.)","Migraine onset prior to 50 years of age","Migraine present for at least 12 months at the time of enrollment","If already taking a migraine preventive treatment, willing to continue with that treatment without dose change during the first 16 weeks of the study, including the 4-week run-in phase and 12-week randomly assigned phase","Not pregnant or breastfeeding","Women of childbearing potential must agree to use effective methods of contraception to reduce the risk of pregnancy"],"whoShouldSkip":["Contraindications to taking atogepant, propranolol, or topiramate","Currently taking atogepant, propranolol, or topiramate\\*","Previously took atogepant, propranolol, or topiramate\\*","Unwillingness to take atogepant, topiramate, or propranolol","Current use of a CGRP-targeting preventive medication or beta-blocker","Migraine with brainstem aura","Hemiplegic migraine"],"whatHappens":"If you join, the listed intervention(s) are Atogepant 60 mg, Propranolol 160 mg, or Topiramate 100 mg. The registry lists allocation as randomized. This goal of this study is to compare three medications used for migraine preventive treatment.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,335 people at 37 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.303Z"},{"nctId":"NCT06974305","title":"PET/MRI/EEG Imaging Study in Epilepsy","officialTitle":"Investigation of Interictal Metabolic and Electrophysiologic Changes in Epilepsy Through Trimodal Neuroimaging","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography \\[FDG-PET\\], and blood flow, measured by functional magnetic resonance imaging \\[fMRI\\]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography \\[EEG\\]). The study will also compare how the three imaging modalities localize regions of abnormal function in the brain.","conditions":["Epilepsy"],"keywords":["Functional PET","FDG-PET","Functional MRI","EEG","Epilepsy","Neuroimaging","Multimodal imaging"],"interventions":[{"type":"RADIATION","name":"FDG-PET/fMRI/EEG imaging"}],"enrollment":30,"startDate":"2023-09-21","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 or older\n\nAdditional Inclusion Criteria for Subjects with Epilepsy:\n\n* Diagnosed with epilepsy with abnormal interictal EEG\n\nExclusion Criteria:\n\n* Contraindications to PET, MRI, or EEG imaging\n* History of severe brain disease such as stroke and head trauma\n* History of brain surgery\n* History of type I or II diabetes mellitus\n* Fasting plasma glucose level \\>200 mg/dL\n* Employed under direct supervision of the PI conducting the research\n\nAdditional Exclusion Criteria for Healthy Subjects:\n\n* Current use of drugs that modulate brain function\n* Current or past history of major medical, neurological, or psychiatric conditions","locations":[{"facility":"Athinoula A. Martinos Center","city":"Charlestown","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Magdelena S Allen, BA","phone":"617-724-9232","email":"mallen27@mgh.harvard.edu"}],"primaryOutcomes":["Image analysis"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["charlestown-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: FDG-PET/fMRI/EEG imaging for Epilepsy","inPlainEnglish":"This study aims to better understand how epilepsy alters brain function through neuroimaging of healthy people and people with epilepsy. The study investigates how changes in brain metabolism (sugar consumption, measured by positron emission tomography \\[FDG-PET\\], and blood flow, measured by functional magnetic resonance imaging \\[fMRI\\]) relate to abnormal interictal electrical activity associated with epilepsy (measured by electroencephalography \\[EEG\\]).","whoItsFor":["Ages 18 Years to any","Additional who can join for Subjects with Epilepsy:","Diagnosed with epilepsy with abnormal interictal EEG"],"whoShouldSkip":["Contraindications to PET, MRI, or EEG imaging","History of severe brain disease such as stroke and head trauma","History of brain surgery","History of type I or II diabetes mellitus","Fasting plasma glucose level \\>200 mg/dL","Employed under direct supervision of the PI conducting the research"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Charlestown. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.913Z"},{"nctId":"NCT06975111","title":"Focusing on the Menopausal Transition to Improve Mid-Life Women's Health","officialTitle":"Focusing on the Menopausal Transition to Improve Mid-Life Women's Health","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms? The ultimate goal of this work is to attenuate future disease and enhance women's quality of life, extend healthspan and increase productivity.","conditions":["Menopause","Menopause Hot Flashes","Menopause Related Conditions","Cardiovascular"],"keywords":[],"interventions":[{"type":"DRUG","name":"Metformin"},{"type":"DRUG","name":"semaglutide"},{"type":"DRUG","name":"Anti-hypertensives"},{"type":"DRUG","name":"Lipid Lowering Medication"},{"type":"BEHAVIORAL","name":"Life style intervention"},{"type":"DRUG","name":"Fezolinetant"},{"type":"DRUG","name":"Hormonal therapy"}],"enrollment":200,"startDate":"2026-03-01","completionDate":"2029-10-31","sex":"FEMALE","minAge":"45 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* aged 45-55\n* In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea\n* No current use of systemic hormone therapy or hormonal contraception, other than progestin-releasing IUDs or oral, micronized progesterone. Vaginal (non-systemic) estrogen use (FDA-approved products only, used as labelled) is permitted and is NOT an exclusion. Other forms of non-FDA approved hormones will need to be reviewed by the study physicians on-site to determine eligibility. Women choosing to discontinue hormonal contraception and/or systemic hormone therapy may become eligible for the study after a washout period\n* Presence of a uterus and at least one ovary in order to track menstrual patterns\n* Have a smartphone and broadband access adequate to accept telehealth appointments\n* No more than 5% weight loss in the last 3 months\n\nExclusion Criteria:\n\n* Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)\n* Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant.\n* Pregnancy or actively trying to get pregnant\n* Inability to adhere to study protocol schedule\n* Untreated alcoholism\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a BMI\\> 30 kg/m2.","locations":[{"facility":"University of Colorado-School of Medicine","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina, School of Medicine","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carrie Hsu, BA","phone":"303-724-5276","email":"carrie.hsu@cuanschutz.edu"},{"name":"Nalia Naushad","phone":"","email":"naila.naushad@cuanschutz.edu"}],"primaryOutcomes":["Epigenetic aging measurements of \"PhenoAge\"","Epigenetic aging measurements of \"GrimAge\""],"hasResults":false,"conditionSlugs":[],"drugSlugs":["semaglutide"],"locationSlugs":["aurora-colorado","chapel-hill-north-carolina","richmond-virginia"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Metformin for Menopause","inPlainEnglish":"What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions? Could these interventions reduce menopause-related inflammation, restore a healthier cardiometabolic profile, reverse epigenetic aging, and reduce bothersome menopausal symptoms?","whoItsFor":["Ages 45 Years to 55 Years","Women only","In the late menopausal transition, defined as 60 days of amenorrhea but less than 365 days of amenorrhea","Presence of a uterus and at least one ovary in order to track menstrual patterns","Have a smartphone and broadband access adequate to accept telehealth appointments","No more than 5% weight loss in the last 3 months"],"whoShouldSkip":["Lack of broadband access (activity and survey data will be collected electronically whenever possible and some visits will be via telehealth)","Lack of regular menstrual periods in mid-reproductive life (ages 25-38) when not on hormones or not pregnant","Pregnancy or actively trying to get pregnant","Inability to adhere to study protocol schedule","Untreated alcoholism","Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia (MEN 2) for participants with a body-mass index (BMI)\\> 30 kg/m2"],"whatHappens":"If you join, the listed intervention(s) are Metformin, semaglutide, or Anti-hypertensives. The registry lists allocation as randomized. What if midlife women, who are inherently at an increased risk for future cardiometabolic disease due to transitioning into menopause, had access to a suite of evidence-based health interventions?","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 200 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.723Z"},{"nctId":"NCT06975865","title":"The Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","officialTitle":"A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Flexible-adaptive, Group Sequential Study to Evaluate the Efficacy and Safety of Rilzabrutinib in Participants Aged 10 to 65 Years With Sickle-cell Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the efficacy, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).\n\nStudy details include:\n\n* Study duration: a 52-week double-blind period (Part A), followed by an open-label LTE period (Part B). Double-blind period has two parts, 50% (adult only) until the interim analysis (a proof-concept part analogous to a phase 2b study), and 50% (adult and children) after the interim analysis. Only the participants who complete double-blind treatment period (Part A) are eligible to continue to the LTE period. The duration of the LTE period (Part B) will be from the first-participant-in (FPI)-LTE (Part B) until the last participant who enters the LTE has completed 52 weeks.\n* Treatment duration: 52-week double-blind period (Part A); LTE period (Part B) from the (FPI until the last participant who enters the LTE has completed 52 weeks.\n* Visit frequency: Week visits based on the Schedule of Assessments.","conditions":["Sickle Cell Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rilzabrutinib"},{"type":"DRUG","name":"Placebo"}],"enrollment":192,"startDate":"2025-08-12","completionDate":"2027-07-23","sex":"ALL","minAge":"10 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who have been diagnosed with SCD.\n* Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events.\n* Participants who are either not on hydroxyurea and/or L-glutamine at the Screening Visit and does not plan to receive them during the course of the study or has received HU and/or L-glutamine for a minimum of 6 months. Participants on hydroxyurea and/or L-glutamine must have been on a stable weight-based dose level (mg/kg) for at least 3 months prior to the Screening Visit, with the intent to continue at the same weight-based dose level for the duration of the study, except for safety reasons.\n* Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* For participants ≥10 to \\<18 years of age: the parent(s)/legal guardian(s) must provide written informed consent prior to any study-related procedures being performed.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply: Participants with medical history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for the past 3 years.\n* Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings.\n* Participants with history of stroke, or history of abnormal transcranial doppler.\n* Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening.\n* HIV infection.\n* A history of active or latent tuberculosis (TB)\n* Positive COVID-19 molecular test.\n* Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"University of Alabama at Birmingham- Site Number : 8400003","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoenix Children's Hospital- Site Number : 8400028","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco- Site Number : 8400040","city":"Clovis","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David Geffen School of Medicine at UCLA- Site Number : 8400032","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Georgetown University Hospital- Site Number : 8400036","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology & Hematology Associates of West Broward- Site Number : 8400029","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sylvester Comprehensive Cancer Center- Site Number : 8400020","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois-Chicago - College of Medicine- Site Number : 8400054","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Riley Hospital for Children- Site Number : 8400056","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louisiana State University Health Sciences Center - Shreveport- Site Number : 8400037","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland School of Medicine - Baltimore- Site Number : 8400041","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Health System - Ann Arbor- Site Number : 8400035","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Specialty Research- Site Number : 8400059","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Richmond University Medical Center- Site Number : 8400038","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center - Moses Campus- Site Number : 8400057","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University (OHSU)- Site Number : 8400043","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health- Site Number : 8400051","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Health Science Center- Site Number : 8400045","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine- Site Number : 8400055","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Physicians - Memorial Hermann- Site Number : 8400052","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400012","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0560003","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0560002","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0560001","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0560004","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Santa Izabel- Site Number : 0760006","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Bahiana de Infectologia- Site Number : 0760009","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universidade Federal de Goias- Site Number : 0760002","city":"Goiânia","state":"Goiás","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760001","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Samaritano De Sao Paulo- Site Number : 0760005","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500002","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500005","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500001","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500004","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760005","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760002","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760004","city":"Stuttgart","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3000001","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3000003","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3000002","city":"Pátrai","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3760001","city":"Afula","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3760002","city":"Afula","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3760005","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3760006","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800006","city":"Florence","state":"Firenze","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800008","city":"Genoa","state":"Genova","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800004","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800005","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800001","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800007","city":"Orbassano","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800002","city":"Palermo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 3800003","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 5280002","city":"Rotterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 5120001","city":"Muscat","state":"","country":"Oman","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 6820003","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240001","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240002","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7920001","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7920002","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7920003","city":"Mersin","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260002","city":"London","state":"Harrow","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260001","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260005","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Annualized rate of clinical VOC"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","clovis-california","los-angeles-california","washington-d-c-district-of-columbia","coral-springs-florida","miami-florida","chicago-illinois","indianapolis-indiana","shreveport-louisiana","baltimore-maryland","ann-arbor-michigan","flowood-mississippi","staten-island-new-york","the-bronx-new-york","portland-oregon","greenville-south-carolina","memphis-tennessee","houston-texas","richmond-virginia","brussels-belgium","leuven-belgium","li-ge-belgium","salvador-brazil","goi-nia-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","cr-teil-france","marseille-france","paris-france","toulouse-france","berlin-germany","essen-germany","stuttgart-germany","athens-greece","p-trai-greece","afula-israel","haifa-israel","florence-italy","genoa-italy","milan-italy","naples-italy","rome-italy","orbassano-italy","palermo-italy","verona-italy","rotterdam-netherlands","muscat-oman","riyadh-saudi-arabia","madrid-spain","adana-turkey-t-rkiye","mersin-turkey-t-rkiye","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Rilzabrutinib for Sickle Cell Disease","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the how well it works, and safety of rilzabrutinib in participants with sickle-cell disease (SCD). Study details include: * Study duration: a 52-week neither you nor the study doctors know who gets the real treatment period (Part A), followed by an open-label LTE period (Part B).","whoItsFor":["Ages 10 Years to 65 Years","Participants who have been diagnosed with SCD","Participants who have had between ≥2 and ≤10 episodes of documented clinical VOC within 12 months of the screening events","Participants with Eastern Cooperative Oncology Group (ECOG) performance status grade 2 or lower","Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies"],"whoShouldSkip":["Clinically relevant cardiac abnormality, in the opinion of the Investigator or electrocardiogram (ECG) findings","Participants with history of stroke, or history of abnormal transcranial doppler","Participants with uncontrolled or active HBV infection and/or HCV infection including those receiving antiviral therapy at the time of screening","A history of active or latent tuberculosis (TB)","Positive COVID-19 molecular test","Participant is taking or has received crizanlizumab (ADAKVEO®) within 90 days and/or voxelotor (OXBRYTA®) within 30 days prior to the Screening visit","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"If you join, the listed intervention(s) are Rilzabrutinib, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, flexible-adaptive, group-sequential study (Part A), followed by an open-label LTE period (Part B) to investigate the how well it works, and safety of rilzabrutinib in participants with sickle-cell disease (SCD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 192 people at 63 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.844Z"},{"nctId":"NCT06977581","title":"A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma","officialTitle":"A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH INADEQUATELY CONTROLLED MODERATE-TO-SEVERE ASTHMA","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected.\n\nThis study is seeking participants who:\n\n* Are 18 to 75 years old\n* Have had moderate-to-severe asthma for at least 12 months that is not well controlled\n* Have been taking their regular maintenance treatment(s) for asthma over the last 6 months\n\nAll participants will receive PF-07275315 or a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied.\n\nPF-07275315 or placebo will be given as multiple shots in the clinic over the course of 12 weeks. We will compare the experiences of people receiving PF-07275315 to those of the people who do not. This will help us determine if PF-07275315 is safe and effective.\n\nParticipants will be involved in this study for up to approximately 9.5 months depending on local requirements.","conditions":["Asthma"],"keywords":["Pulmonary","Wheezing","Respiratory hypersensitivity","Airway Inflammation","Airway Obstruction","Dyspnea","Lung Diseases","Respiratory Tract Diseases","Asthma"],"interventions":[{"type":"DRUG","name":"PF-07275315"},{"type":"OTHER","name":"Placebo"}],"enrollment":252,"startDate":"2025-05-20","completionDate":"2027-03-08","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nMust meet the following asthma criteria:\n\n1. History of persistent, moderate-to-severe asthma for at least 12 months prior to screening.\n2. Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 24 months of the screening visit.\n3. At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to \\<80% of predicted normal values.\n4. Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period.\n5. Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit.\n6. ACQ-5 score of ≥1.5 at screening visit and prior to randomization.\n\n   Other Inclusion Criteria:\n7. Body mass index between 18 -40 kg/m2 at screening.\n\nExclusion Criteria:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n2. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to: Chronic obstructive pulmonary disease, Other emphysematous lung disease such as alpha-1 antitrypsin disease, Cystic fibrosis, Emphysema, Idiopathic pulmonary fibrosis, Churg-Strauss syndrome, Allergic bronchopulmonary aspergillosis, Sarcoidosis\n3. Diagnosed with any of the following acute or chronic infections or infection history:\n\n   * Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;\n   * Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;\n   * Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1.\n\n   Prior/Concomitant Therapy:\n4. Prior or current use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s).\n5. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4, IL-13, IL-33/ST2, IL-4Rα, TSLP, IL-5, OX40/OX40L or IgE) or targeted synthetic drugs (such as JAK inhibitors) for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.\n6. Treatment with any dose level of systemic (oral, injectable, or intraarticular) corticosteroids within 28 days of the screening visit.\n7. Prior (within 12 weeks prior to screening) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).\n8. History of anaphylaxis to antibody therapeutic or to PF-07275315 or to the excipients of the formulated drug products.\n9. Bronchial thermoplasty within the previous 24 months.\n\n   Prior/Concurrent Clinical Study Experience:\n10. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Participation in studies of other investigational products (drug or vaccine) at any time during participation in this study.","locations":[{"facility":"Velocity Clinical Research, Mobile","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chandler Clinical Trials","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antelope Valley Clinical Trials","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewportNativeMD, Inc.","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Medical Research Associates","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy and Asthma Associates of Santa Clara Valley Research 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Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation-Linkou Branch","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Outpatients","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wythenshawe Hospital","city":"Manchester","state":"Greater Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital","city":"London","state":"London, CITY of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradford Royal Infirmary","city":"Bradford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Manchester General Hospital","city":"Crumpsall","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pinderfields General Hospital","city":"Wakefield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change from baseline in pre-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12","Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), and AEs/SAEs leading to treatment discontinuation","Clinically significant, treatment-related laboratory abnormalities","Clinically significant, treatment-related abnormalities in vital signs","Clinically significant, treatment-related electrocardiogram (ECG) abnormalities"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["mobile-alabama","chandler-arizona","lancaster-california","newport-beach-california","northridge-california","san-jose-california","walnut-creek-california","colorado-springs-colorado","east-point-georgia","champaign-illinois","kansas-city-kansas","ann-arbor-michigan","st-louis-missouri","henderson-nevada","new-brunswick-new-jersey","riverdale-new-jersey","charlotte-north-carolina","gastonia-north-carolina","huntersville-north-carolina","toledo-ohio","edmond-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","dubois-pennsylvania","rock-hill-south-carolina","hendersonville-tennessee","boerne-texas","cypress-texas","dallas-texas","houston-texas","mckinney-texas","richmond-virginia","ciudad-aut-noma-de-buenos-aires-argentina","mar-del-plata-argentina","buenos-aires-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","mendoza-argentina","mechelen-belgium","ghent-belgium","li-ge-belgium","sofia-bulgaria","haskovo-bulgaria","stara-zagora-bulgaria","beijing-china","guangzhou-china","baotou-china","hohhot-china","najing-china","nanjing-china","xuzhou-china","nanchang-china","changchun-china","xian-china","shanghai-china","chengdu-china","hangzhou-china","taizhou-china","brand-s-nad-labem-czechia","jindrichuv-hradec-iii-czechia","hradec-kr-lov-czechia","lovosice-czechia","edel-ny-hungary","mosonmagyar-v-r-hungary","hajd-n-n-s-hungary","g-d-ll-hungary","p-cs-hungary","monserrato-italy","reggio-emilia-italy","rozzano-italy","orbassano-italy","siena-italy","salerno-italy","torino-italy","aki-gun-fuchu-cho-japan","kobe-japan","kawachi-nagano-japan","sakai-japan","fujieda-japan","hamamatsu-japan","chuo-ku-japan","hachi-ji-japan","fukuoka-japan","hiroshima-japan","poznan-poland","krakow-poland","tarn-w-poland","wroclaw-poland","bychawa-poland","sosnowiec-poland","johannesberg-south-africa","johannesburg-south-africa","durban-south-africa","jeonju-south-korea","daegu-south-korea","seoul-south-korea","santander-spain","pozuelo-de-alarc-n-spain","madrid-spain","m-laga-spain","changhua-county-taiwan","new-taipei-city-taiwan","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","taoyuan-taiwan","cambridge-united-kingdom","manchester-united-kingdom","london-united-kingdom","bradford-united-kingdom","crumpsall-united-kingdom","wakefield-united-kingdom"],"enrichment":{"headline":"Phase 2: testing PF-07275315 for Asthma","inPlainEnglish":"The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life and functioning of people who are affected.","whoItsFor":["Ages 18 Years to 75 Years","Must meet the following asthma criteria:","History of persistent, moderate-to-severe asthma for at least 12 months prior to screening","Must have experienced at least 1 asthma exacerbation requiring treatment with systemic steroids (oral or parenteral) for 3 days or more within 24 months of the screening visit","At least 2 of the 3 pre-bronchodilator FEV1 values collected in the run-in period and the mean of the of pre-bronchodilator FEV1 values collected in the run-in period are ≥30% to \\<80% of predicted normal values","Positive bronchodilator responsiveness as evidenced by increase in FEV1 of at least 12% and 200 mL for spirometry conducted during screening period","Maintenance (controller) treatment that minimally includes a medium to high dose ICS - LABA combination consistent with GINA Step 4/5 (either Track 1 or Track 2) for 6 months prior to the screening visit and at a stable dose for at least 3 months prior to the screening visit","ACQ-5 score of ≥1.5 at screening visit and prior to randomization"],"whoShouldSkip":["Medical Conditions:","Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study","Diagnosed with any of the following acute or chronic infections or infection history:","Active helminth or parasitic infection requiring treatment within 2 weeks prior to screening;","Infection requiring hospitalization or systemic (parenteral) antimicrobial therapy within 60 days prior to Day 1;","Any infection judged to be an opportunistic infection or clinically significant by the investigator, within 6 months prior to Day 1","Prior/Concomitant Therapy:"],"whatHappens":"If you join, the listed intervention(s) are PF-07275315, or Placebo. The registry lists allocation as randomized. The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07275315) for the potential treatment of moderate-to-severe asthma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 252 people at 137 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.344Z"},{"nctId":"NCT06978647","title":"A Clinical Study of YTS109 Cell in R/R Autoimmune Diseases","officialTitle":"An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Diseases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"China Immunotech (Beijing) Biotechnology Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg). The main purpose of exploratory clinical research is to explore the efficacy and safety of YTS109 cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.","conditions":["Systemic Lupus Erythematosus (SLE)","Systemic Sclerosis (SSc)","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome (APS)","Rheumatoid Arthritis (RA)","IgG4-Related Diseases","Sjogren&#39;s Syndrome"],"keywords":[],"interventions":[{"type":"DRUG","name":"YTS109 cell"}],"enrollment":12,"startDate":"2025-05-19","completionDate":"2027-05-19","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Detection of positive CD19 expression on peripheral blood B cells by flow cytometry.\n3. Essential Organ Function Criteria:\n\n<!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).\n\n   Hemoglobin ≥60 g/L.\n2. Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL ≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR/PT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 4. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n5\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1\\. Meeting the EULAR/ACR 2019 SLE Classification Criteria; 2. SELENA SLEDAI≥6, or the presence of significant organ involvement, such as lupus nephritis (LN), etc; 3. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing treatment with a regimen containing at least two immunosuppressive agents (including glucocorticoids, cyclophosphamide, tacrolimus, mycophenolate mofetil (MMF), and cyclosporine) and/or biological agents for a minimum duration of two months.\n\nRelapsing and refractory Sjögren's syndrome:\n\n1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for primary Sjögren's syndrome;\n2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n3. Testing positive for anti-SSA/Ro antibodies;\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Sjogren's Syndrome:\n\n1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n2. Testing positive for systemic sclerosis-related antibodies;\n3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Inflammatory Myopathy:\n\n1. Meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n2. Testing positive for myositis-specific antibodies;\n3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\nNote: Meeting either criterion 4 or 5 is sufficient.\n\nRelapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n\n1. Meeting the 2022 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n4. Definition of relapsing/refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\nRelapsing and refractory Antiphospholipid Syndrome:\n\n1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG/IgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing/refractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and/or tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\nNote: Meeting either criterion 3 or 4 is sufficient.\n\nRelapsing and refractory Rheumatoid arthritis:\n\n1\\. Diagnosed with rheumatoid arthritis (RA) according to the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, with a history of RA ≥ 3 months; 2. Inadequate response to at least two conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) and at least one biological agent targeting cytokines/signal transduction pathways (such as TNFα inhibitors, IL-6R antagonists, anti-CD20 monoclonal antibodies, etc.). (Note: Inadequate response to methotrexate or leflunomide, with stable treatment for ≥ 3 months prior to screening); 3. Moderate to severe active RA: swollen joint count (SJC) ≥ 6, tender joint count (TJC) ≥ 6; 4. Elevation of at least one inflammatory marker: erythrocyte sedimentation rate (ESR) ≥ 28 mm/h or C-reactive protein (CRP) ≥ upper limit of normal (ULN).\n\nRelapsing and refractory IgG4-Related Disease:\n\n1. Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for IgG4-related disease (IgG4-RD);\n2. Having an IgG4-RD responder index (RI) ≥ 2 during the screening period, indicating active disease;\n3. Meeting the criteria for refractory or relapsing IgG4-RD:\n\n1\\) Refractory: Defined as a lack of response to steroid therapy or steroid plus immunosuppressive therapy (no clinical or radiological improvement, with a decrease in RI \\< 2); 2) Relapse: Defined as new progression or recurrence of clinical symptoms or radiological manifestations in patients who have previously achieved remission, with or without an elevation in serum IgG4 levels (an increase in RI ≥ 2).\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n  1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n  2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n  3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n  4. Subjects whose cardiac function cannot tolerate the study interventions;\n  5. Subjects with congenital immunoglobulin deficiencies;\n  6. Subjects with a history of malignant tumors within the past five years;\n  7. Subjects with end-stage renal failure;\n  8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n  9. Subjects with psychiatric disorders or severe cognitive dysfunction;\n  10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n  11. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n  12. Pregnant women or women planning to become pregnant;\n  13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.","locations":[{"facility":"The First Medical Center of Chinese PLA General Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jian Zhu","phone":"8610-66937166","email":"jian_jzhu@126.com"}],"primaryOutcomes":["Incidence of Treatment-Emergent Adverse Events"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 1: testing YTS109 cell for Systemic Lupus Erythematosus (SLE)","inPlainEnglish":"This study evaluates the safety and how well it works of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg).","whoItsFor":["Ages 18 Years to 65 Years","Subjects must meet both the following common who can join and disease-specific who can join simultaneously to be eligible for participation in this study:","Common who can join:","Age ranges from 18 to 65 years old (including threshold), regardless of gender","Detection of positive CD19 expression on peripheral blood B cells by flow cytometry","Essential Organ Function Criteria:","Bone marrow: Neutrophils ≥1×10\\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use)","Hemoglobin ≥60 g/L"],"whoShouldSkip":["Subjects who meet any of the following"],"whatHappens":"If you join, the listed intervention(s) are YTS109 cell. The registry lists allocation as na. This study evaluates the safety and how well it works of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.965Z"},{"nctId":"NCT06979401","title":"Effect of Sensory Training on Functional Performance, Balance, Gait in Type 2 Diabetic Individuals With Neuropathy","officialTitle":"Effects of Foot Sensory Training on Plantar Sensation, Functional Performance, Balance, Gait and Kinesiophobia in Type 2 Diabetic Individuals With Neuropathy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Aylin DEMİR","sponsorClass":"OTHER","summary":"Diabetic peripheral neuropathy (DPN) is a common complication of both type 1 and type 2 diabetes. DPN is characterized by significant axonal degeneration and segmental demyelination that affect sensory and motor nerves. While various studies in the literature have examined the impact of plantar sensation on gait and balance parameters, no research has yet investigated the effects of foot sensory training on plantar sensation, functional performance, balance, gait, and kinesiophobia in individuals with type 2 diabetes and neuropathy. To contribute to the existing literature, 40 individuals with type 2 diabetes and neuropathy-recruited from the Endocrinology and Metabolism Diseases Outpatient Clinic at Dursun Odabaş Medical Center-will be enrolled in this randomized controlled trial. Following the provision of diabetic foot education to all participants, they will be assigned to either an experimental group (n=20) or a control group (n=20) using a sequential randomization method. The experimental group will receive foot sensory training, while the control group will receive no intervention; however, upon completion of the study, sensory training will be offered to any participants in the control group who request it. All participants will be assessed at the beginning and end of the training period in terms of foot sensation, functional performance, balance, gait, and kinesiophobia. Foot sensation will be evaluated using light touch, two-point discrimination, and vibration tests. Functional performance will be assessed via the \"Timed Up and Go\" (TUG) test and a timed stair-climbing (ascending and descending) test. Kinesiophobia will be measured using the Tampa Scale for Kinesiophobia. Balance will be assessed using the single-leg stance test and the Y-balance test, while gait will be analyzed via software based on the Kinect V2 camera. Physical activity levels will be evaluated using the International Physical Activity Questionnaire-Short Form (IPAQ-SF). Data obtained from the study will be analyzed using SPSS (Statistical Package for the Social Sciences) software. Data values will be expressed as percentages, means, and standard deviations; for comparison tests, the significance level (p) will be set at 0.05.","conditions":["Diabetes","Type 2 Diabetes","Diabetic Peripheral Neuropathy","Kinesiophobia","Balance","Functional Performance","Gait Analysis","Plantar Sensation"],"keywords":["balance","Plantar Sensation","type 2 diabetes","gait","kinesiophobia","functional performance","diabetic peripheral neuropathy"],"interventions":[{"type":"OTHER","name":"Exercise"}],"enrollment":40,"startDate":"2026-06-23","completionDate":"2027-06-01","sex":"ALL","minAge":"35 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Being 35-65 years old\n* Being diagnosed with type 2 diabetes\n* Having given less than 8 correct answers in the Semmes-Weinstein Monofilament test performed with a 5.07 monofilament\n* Getting a Neuropathy Disability Score of 3 and above\n* Being willing to participate in the study\n* Being literate\n\nExclusion Criteria:\n\n* Having a neurological or orthopedic comorbidity\n* Having a respiratory disease such as uncontrolled COPD or asthma\n* Having active lower extremity ulceration\n* Using medications known to affect the postural control system such as benzodiazepines\n* Having nephropathy, retinopathy and diabetic arthritis at a level that may affect mobility in addition to neuropathy\n* Using a walking aid\n* Body Mass Index \\>30\n* Having communication problems\n* Not participating in at least 3 consecutive exercise sessions\n* Not participating in more than 30% of each session","locations":[{"facility":"Van Yüzüncü Yıl University Dursun Odabaş Medical Center","city":"Van","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aylin Demir, research assistant","phone":"+904382126213","email":"ayln.dmir@gmail.com"}],"primaryOutcomes":["Tampa Kinesiophobia Scale","Evaluation of Light touch sense","Timed Up and Go Test","Single Leg StanceTest","Gait Analysis","Evaluation of vibration sense","Evaluation of Two-point discrimination sense","Stair Climb Test","Y Balance test"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":[],"locationSlugs":["van-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Exercise for Diabetes","inPlainEnglish":"Diabetic peripheral neuropathy (DPN) is a common complication of both type 1 and type 2 diabetes. DPN is characterized by significant axonal degeneration and segmental demyelination that affect sensory and motor nerves.","whoItsFor":["Ages 35 Years to 65 Years","Being 35-65 years old","Being diagnosed with type 2 diabetes","Having given less than 8 correct answers in the Semmes-Weinstein Monofilament test performed with a 5.07 monofilament","Getting a Neuropathy Disability Score of 3 and above"],"whoShouldSkip":["Having a neurological or orthopedic comorbidity","Having a respiratory disease such as uncontrolled COPD or asthma","Having active lower extremity ulceration","Using medications known to affect the postural control system such as benzodiazepines","Having nephropathy, retinopathy and diabetic arthritis at a level that may affect mobility in addition to neuropathy","Using a walking aid","Body Mass Index \\>30"],"whatHappens":"If you join, the listed intervention(s) are Exercise. The registry lists allocation as randomized. Diabetic peripheral neuropathy (DPN) is a common complication of both type 1 and type 2 diabetes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Van. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.518Z"},{"nctId":"NCT06979453","title":"A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis","conditions":["Plaque Psoriasis"],"keywords":["Psoriasis","Rash","Itch","Teen","Dermatology","Derm","POETYK-PsO-Peds-1"],"interventions":[{"type":"DRUG","name":"Deucravacitinib"},{"type":"OTHER","name":"Placebo"}],"enrollment":366,"startDate":"2025-12-03","completionDate":"2029-10-12","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have stable plaque psoriasis for 6 months or more prior to Screening.\n* Participants must have moderate to severe psoriasis defined by:.\n\n  i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.\n\nii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.\n\niii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.\n\n\\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.\n\ni) Is not an individual of childbearing potential (IOCBP).\n\nii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \\< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.\n\nExclusion Criteria\n\n* Participants must not weigh \\< 30.0 kg at Screening and Day 1.\n* Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.\n* Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.\n* Participants must not have any untreated bacterial infection within 60 days prior to Day 1.\n* Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).\n* Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.\n* Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.\n* Participants must not have had any prior exposure to deucravacitinib.\n* Participants must not have received any medication that is specifically prohibited.\n* Participants must not have a laboratory finding that is exclusionary.\n* Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.\n* Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.\n* Other protocol-defined 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improvement in Psoriasis Area and Severity Index (PASI 75)","Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","fountain-valley-california","fremont-california","los-angeles-california","northridge-california","sacramento-california","walnut-creek-california","wheat-ridge-colorado","clearwater-florida","margate-florida","miami-florida","miami-lakes-florida","tampa-florida","atlanta-georgia","sandy-springs-georgia","ammon-idaho","indianapolis-indiana","murray-kentucky","metairie-louisiana","rockville-maryland","milford-massachusetts","detroit-michigan","columbia-missouri","lees-summit-missouri","las-vegas-nevada","clifton-new-jersey","robbinsville-new-jersey","new-york-new-york","the-bronx-new-york","hickory-north-carolina","canton-ohio","lorain-ohio","mayfield-heights-ohio","philadelphia-pennsylvania","goodlettsville-tennessee","nashville-tennessee","houston-texas","san-antonio-texas","southlake-texas","norfolk-virginia","mill-creek-washington","spokane-washington","ciudad-autonoma-de-buenos-aires-argentina","san-m-de-tucuman-argentina","buenos-aires-argentina","brussels-belgium","ghent-belgium","li-ge-belgium","salvador-brazil","curitiba-brazil","porto-alegre-brazil","campinas-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","edmonton-canada","winnipeg-canada","st-johns-canada","london-canada","richmond-hill-canada","toronto-canada","montreal-canada","beijing-china","guangzhou-china","shenzhen-china","handan-china","zhengzhou-china","changsha-china","jinan-china","shanghai-china","chengdu-china","hangzhou-china","medell-n-colombia","barranquilla-colombia","bogota-colombia","m-nster-germany","mainz-germany","berlin-germany","dresden-germany","erlangen-germany","szeged-hungary","budapest-hungary","debrecen-hungary","rome-italy","roma-italy","zapopan-mexico","mexico-city-mexico","monterrey-mexico","chihuahua-city-mexico","m-rida-mexico","toluca-mexico","veracruz-mexico","lublin-poland","warsaw-poland","bialystok-poland","gdansk-poland","lodz-poland","olsztyn-poland","bayam-n-puerto-rico","caguas-puerto-rico","san-juan-puerto-rico","bucharest-romania","cluj-napoca-romania","ia-i-romania","timi-oara-romania","esplugues-de-llobregat-spain","barcelona-spain","madrid-spain","santiago-de-compostela-spain","kaohsiung-niao-sung-dist-taiwan","kaohsiung-city-taiwan","taipei-taiwan","taoyuan-taiwan"],"enrichment":{"headline":"Phase 3: testing Deucravacitinib for Plaque Psoriasis","inPlainEnglish":"This study wants to measure the how well it works, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis","whoItsFor":["Ages 12 Years to 17 Years","Participants must have stable plaque psoriasis for 6 months or more prior to Screening","Participants must have moderate to severe psoriasis defined by:","i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1","ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1","iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1","\\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:","i) Is not an individual of childbearing potential (IOCBP)"],"whoShouldSkip":["Participants must not weigh \\< 30.0 kg at Screening and Day 1","Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1","Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1","Participants must not have any untreated bacterial infection within 60 days prior to Day 1","Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)","Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions","Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention"],"whatHappens":"If you join, the listed intervention(s) are Deucravacitinib, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 366 people at 133 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.583Z"},{"nctId":"NCT06981585","title":"Physical Impairments in Children With Chronic Renal Failure","officialTitle":"Comparison of Muscle Strength, Physical Activity, Sleep Quality and Quality of Life Between Children With Chronic Kidney Failure and Healthy Children","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Izmir Democracy University","sponsorClass":"OTHER","summary":"When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. For this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.","conditions":["Chronic Kidney Failure","Chronic Kidney Diseases"],"keywords":["Chronic Kidney Failure","Muscle Strength","Physical Activity","Sleep Quality","Quality of Life"],"interventions":[{"type":"OTHER","name":"Physical Evaluations of Patients with Chronic Kidney Failure"},{"type":"OTHER","name":"Physical Evaluations of Healthy Children"}],"enrollment":25,"startDate":"2025-08-01","completionDate":"2027-03-01","sex":"ALL","minAge":"8 Years","maxAge":"18 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria: for Children and Adolescents with Chronic Kidney Failure\n\n* Being between the ages of 8-18\n* Being clinically stable for at least the last 3 weeks\n* Having the necessary cooperation for the measurements\n* Being willing to participate in the study\n\nInclusion Criteria for Healthy Children and Adolescents:\n\n* Being between the ages of 8-18,\n* Having the necessary cooperation for the measurements,\n* Being willing to participate in the research\n\nExclusion Criteria: for Children and Adolescents with Chronic Kidney Failure\n\n* Having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months\n* Being a smoker or having quit\n* Having had a kidney transplant.\n\nExclusion Criteria for Healthy Children and Adolescents:\n\n* Having a history of any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months\n* Having any chronic disease\n* Being a smoker or having quit smoking","locations":[{"facility":"İzmir Demokrasi Üniversitesi","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gülşah Barğı","phone":"+90 232 299 0739","email":"gulsahbargi35@gmail.com"},{"name":"Hüseyin Kıran","phone":"+90 531 706 8000","email":"huseyinulaskiran@gmail.com"}],"primaryOutcomes":["Quality of life score"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["izmir-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Physical Evaluations of Patients with Chronic Kidney Failure for Chronic Kidney Failure","inPlainEnglish":"When the literature is examined, it is seen that the extent to which cough strength, grip strength, physical activity level and quality of life levels are affected in children with chronic kidney failure compared to healthy children is not sufficiently clarified. For this reason, this study aimed to reveal impairments in grip strength, cough strength, physical activity, sleep quality or quality of life in children with chronic renal failure compared to healthy children.","whoItsFor":["Ages 8 Years to 18 Years","for Children and Adolescents with Chronic Kidney Failure","Being between the ages of 8-18","Being clinically stable for at least the last 3 weeks","Having the necessary cooperation for the measurements","who can join for Healthy Children and Adolescents:","Being between the ages of 8-18,","Having the necessary cooperation for the measurements,"],"whoShouldSkip":["for Children and Adolescents with Chronic Kidney Failure","Having any orthopedic, neurological, cardiovascular or psychological problems that may prevent measurements from being taken in the last 6 months","Being a smoker or having quit","Having had a kidney transplant"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 25 people at Izmir. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.497Z"},{"nctId":"NCT06983743","title":"A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors","officialTitle":"A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Erasca, Inc.","sponsorClass":"INDUSTRY","summary":"The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.","conditions":["Metastatic Solid Tumors"],"keywords":["Solid Tumor","Advanced Solid Tumor","solid malignancies","Targeted therapy","Molecular alterations","pembrolizumab","KEYTRUDA ®","panitumumab","Vectibix","Metastatic Solid Tumor","Neoplasms","Colorectal Cancer","Non-small cell lung cancer (NSCLC)","Newly diagnosed Pancreatic Ductal Adenocarcinoma","NSCLC patients previously treated with a KRAS G12c inhibitor"],"interventions":[{"type":"DRUG","name":"ERAS-0015"},{"type":"DRUG","name":"ERAS-0015 in combination"}],"enrollment":600,"startDate":"2025-06-05","completionDate":"2028-05-01","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Willing and able to give written informed consent\n* Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohorts.\n* There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort.\n* Able to swallow oral medication\n* Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Adequate cardiovascular, hematological, liver, and renal function\n* Willing to comply with all protocol-required visits, assessments, and procedures\n\nExclusion Criteria:\n\n* Previous treatment with a RAS inhibitor\n* Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-0015\n* Received prior palliative radiation within 14 days of Cycle 1, Day 1\n* Have primary central nervous system (CNS) tumors\n* Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption\n* Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs\n* Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial","locations":[{"facility":"Providence Medical Group","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specalists","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital (MG)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas at Tyler","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Princess Margaret Cancer Center","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inje University Haeundae Paik Hospital Clinical Trial Center","city":"Haeundae","state":"Busan","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul St. Mary's Hospital Clinical Trial Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erasca Clinical Team Team","phone":"+1-858-465-6511","email":"clinicaltrials@erasca.com"},{"name":"Les Brail, Study Director, PhD","phone":"","email":""}],"primaryOutcomes":["Dose Limiting Toxicities (DLT)","Maximum tolerated dose (MTD)","Recommended dose for expansion (RDE)","Adverse Events","Plasma concentration (Cmax)","Time to achieve Cmax (Tmax)","Area under the curve","Half-life"],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["santa-rosa-california","aurora-colorado","sarasota-florida","tampa-florida","atlanta-georgia","boston-massachusetts","new-york-new-york","houston-texas","tyler-texas","fairfax-virginia","toronto-canada","haeundae-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing ERAS-0015 for Metastatic Solid Tumors","inPlainEnglish":"The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments.","whoItsFor":["Ages 18 Years to 99 Years","Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohorts","Able to swallow oral medication","Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1","Adequate cardiovascular, hematological, liver, and renal function"],"whoShouldSkip":["Previous treatment with a RAS inhibitor","Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-0015","Received prior palliative radiation within 14 days of Cycle 1, Day 1","Have primary central nervous system (CNS) tumors","Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption","Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs","Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial"],"whatHappens":"If you join, the listed intervention(s) are ERAS-0015, or ERAS-0015 in combination. The registry lists allocation as randomized. The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 600 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.077Z"},{"nctId":"NCT06985706","title":"Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser for Treating Severe Diabetic Macular Oedema When the Central Retina Goes <400 Microns","officialTitle":"Treatment of Severe Diabetic Macular Oedema With Anti-vascular Endothelial Growth Factor (Anti-VEGF) Monotherapy vs Anti-VEGF Followed by Subthreshold Micropulse Laser When the Thickness of the Central Retina Goes Below 400 Microns: Pragmatic Randomised Equivalence Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Belfast Health and Social Care Trust","sponsorClass":"OTHER","summary":"The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO). In DMO, fluid leaks from blood vessels and builds up at the macula, causing sight loss. DMO can be mild or severe; this is determined by measuring, in microns (µm), how thick the macula is. One µm is one-thousandth of a millimetre. People presenting with mild DMO (macula less than 400 µm thick; normally it is around 250 µm but varies with sex and ethnicity) are offered macular laser treatment. Laser works well for these patients. Subthreshold micropulse laser (SML), which does not damage the macula, works as well as standard laser, which produces a burn, and is cost-effective. However, many people present with severe DMO (macula 400 µm or thicker) where the laser does not work well. The standard treatment is eye injections of anti-VEGFs. VEGF stands for vascular endothelial growth factor. VEGF is high in eyes with DMO and causes blood vessel leakage. Anti-VEGFs block VEGF. They are given monthly to begin with, then every 2-3 months for months or years until DMO clears. In many patients DMO comes back after clearing and anti-VEGFs need to be re-started most often monthly initially again. To improve the care of people with severe DMO this study will compare the current standard care (anti-VEGFs alone) with a strategy in which patients begin with an anti-VEGF but switch to SML once the macula is less than 400 µm thick.\n\nPatients aged over 18 years with type 1 or type 2 diabetes and severe DMO can participate. They are randomly allocated either anti-VEGFs alone or anti-VEGFs then SML when the macula is less than 400 µm thick.","conditions":["Severe Diabetic Macular Oedema"],"keywords":["Diabetic macular oedema","anti-VEGF","Subthreshold micropulse laser"],"interventions":[{"type":"PROCEDURE","name":"Subthreshold Micropulse Laser (SML)"},{"type":"DRUG","name":"Anti-VEGF Monotherapy (standard care)"}],"enrollment":264,"startDate":"2025-05-19","completionDate":"2028-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (\\>18 years)\n* Diabetes type 1 or type 2\n* Presented with severe centre-involving (CI)-DMO (CRT ≥400 μm)\n* Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 μm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes\n\nExclusion Criteria:\n\n* Causes of macular oedema other than DMO\n* DMO with CRT ≥400 μm\n* Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed)\n* Use of unlicensed anti-VEGFs (e.g. bevacizumab)\n* Inability, for any reason, to attend study visits\n* Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed)\n* Use of pioglitazone which cannot be stopped for the duration of the trial\n* Cataract surgery or laser pan-retinal photocoagulation (PRP) within the previous 6 weeks\n* Currently enrolled in a Clinical Trial of an Investigational Medical Product\n* Declined consent for participation","locations":[{"facility":"Bedford Hospital","city":"Bedford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Hospitals Belfast","city":"Belfast","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham and Midland Eye Centre","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sussex Eye Hospital","city":"Brighton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bristol Eye Hospital","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frimley Park Hospital","city":"Camberley","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Wales","city":"Cardiff","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gloucestershire Royal Hospital","city":"Gloucester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hull Royal Infirmary","city":"Hull","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Liverpool University Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Middlesex Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chelsea and Westminster Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kings College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moorfields Eye Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Cook Hospital","city":"Middlesbrough","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Gwent Hospital","city":"Newport","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen's Medical Centre","city":"Nottingham","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Southampton","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunderland Eye Hospital","city":"Sunderland","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Singleton Hospital","city":"Swansea","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Torbay Hospital","city":"Torquay","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hillingdon Hospital","city":"Uxbridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mary Guiney","phone":"+44 28 96151447","email":"mary.guiney@nictu.hscni.net"}],"primaryOutcomes":["Best-Corrected Visual Acuity (BCVA)"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["bedford-united-kingdom","belfast-united-kingdom","birmingham-united-kingdom","brighton-united-kingdom","bristol-united-kingdom","camberley-united-kingdom","cardiff-united-kingdom","gloucester-united-kingdom","hull-united-kingdom","liverpool-united-kingdom","london-united-kingdom","middlesbrough-united-kingdom","newport-united-kingdom","nottingham-united-kingdom","southampton-united-kingdom","sunderland-united-kingdom","swansea-united-kingdom","torquay-united-kingdom","uxbridge-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Anti-VEGF Monotherapy (standard care) for Severe Diabetic Macular Oedema","inPlainEnglish":"The macula is the centre of the retina; it gives central sight, colour and fine detail. People with diabetes may develop diabetic macular oedema (DMO).","whoItsFor":["Ages 18 Years to any","Adults (\\>18 years)","Diabetes type 1 or type 2","Presented with severe centre-involving (CI)-DMO (CRT ≥400 μm)","Within the first year of initiating anti-VEGF therapy but who still have DMO and their CRT is below 400 μm (and it remains, at the time of randomisation) following anti-VEGF therapy in either one eye or both eyes"],"whoShouldSkip":["Causes of macular oedema other than DMO","DMO with CRT ≥400 μm","Receipt of anti-VEGFs before their presentation with severe DMO (previous macular laser treatment for DMO is allowed)","Use of unlicensed anti-VEGFs (e.g. bevacizumab)","Inability, for any reason, to attend study visits","Active proliferative diabetic retinopathy (PDR) (treated and inactive PDR is allowed)","Use of pioglitazone which cannot be stopped for the duration of the trial"],"whatHappens":"If you join, the listed intervention(s) are Subthreshold Micropulse Laser (SML), or Anti-VEGF Monotherapy (standard care). The registry lists allocation as randomized. The macula is the centre of the retina; it gives central sight, colour and fine detail.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 264 people at 22 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.128Z"},{"nctId":"NCT06985784","title":"Virtual Reality Interventions for the Improvement of Depression, Anxiety and Pain in Patients With Head and Neck Cancer and Caregivers","officialTitle":"Enhancing Patient Well-Being: Feasibility of Virtual Reality in Head and Neck Cancer Patients to Improve Depressive Symptomatology, Anxiety and Pain","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life. VR allows for a realistic experience and works as an effective distraction tool from the state of pain or anxiety without use of drugs and with minimal associated risk to patients. VR has been shown to help reduce symptoms of depression, anxiety and pain in non-cancer patients, however there is limited evidence of how well VR use works in cancer patients, especially in patients undergoing C/RT for HNC. Caregivers of these patients also experience high levels of anxiety and distress. Using VR interventions may improve depression, anxiety, pain and/or stress in patients with HNC undergoing C/RT and their caregivers.","conditions":["Head and Neck Carcinoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Interview"},{"type":"OTHER","name":"Medical Device Usage and Evaluation"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"OTHER","name":"Virtual Technology Intervention"},{"type":"OTHER","name":"Virtual Technology Intervention"}],"enrollment":40,"startDate":"2025-06-25","completionDate":"2027-11-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* PATIENTS: Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* PATIENTS: ≥ 18 years\n* PATIENTS: Self-reported normal or corrected to normal vision and hearing\n* PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)\n* PATIENTS: Ability to read and understand English for questionnaires\n* PATIENTS: Scheduled to undergo C/RT for their HNC\n* CAREGIVERS: Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* CAREGIVERS: ≥ 18 years\n* CAREGIVERS: Self-reported normal or corrected to normal vision and hearing\n* CAREGIVERS: Ability to read and understand English for questionnaires\n* CAREGIVERS: A care giver identified by the patient and defined as a person who knows the patient well and is involved in the patient's medical care\n\nExclusion Criteria:\n\n* PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager\n* PATIENTS: A direct study team member\n* PATIENTS: Inability to complete the surveys\n* PATIENTS: Serious mental illness\n* PATIENTS: Previous head and neck cancer treatment\n* PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (\\> 3 months)\n* PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment\n* CAREGIVERS: An employee who is under the direct/ indirect supervision of the PI/ a co-investigator/ the study manager\n* CAREGIVERS: A direct study team member\n* CAREGIVERS: Inability to complete the surveys\n* CAREGIVERS: Serious mental illness\n* CAREGIVERS: History of any psychiatric disease treatment with anti-depressants, substance abuse, PTSD","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Recruitment rate (Feasibility)","Retention rate (Feasibility)","Adherence to three-dimensional (3D) mindfulness virtual reality (VR) intervention (Feasibility)","Completion of electronic patient reported outcomes (ePRO) (Feasibility)","Acceptability of 3D mindfulness VR intervention"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer","als","depression"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Not a traditional drug phase: Interview for Head and Neck Carcinoma","inPlainEnglish":"This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers. HNC patients undergoing C/RT can experience higher levels of depression, anxiety, distress and pain that negatively impact their quality of life.","whoItsFor":["Ages 18 Years to any","Assent, when appropriate, will be obtained per institutional guidelines","PATIENTS: ≥ 18 years","PATIENTS: Self-reported normal or corrected to normal vision and hearing","PATIENTS: Ambulatory (permitted to use walking aids such as cane or crutch)","PATIENTS: Ability to read and understand English for questionnaires","PATIENTS: Scheduled to undergo C/RT for their HNC","CAREGIVERS: ≥ 18 years"],"whoShouldSkip":["PATIENTS: An employee who is under the direct/ indirect supervision of the principal investigator (PI)/ a co-investigator/ the study manager","PATIENTS: A direct study team member","PATIENTS: Inability to complete the surveys","PATIENTS: Serious mental illness","PATIENTS: Previous head and neck cancer treatment","PATIENTS: History of any psychiatric disease treatment with anti-depressants, substance abuse, post-traumatic stress disorder (PTSD), chronic pain (\\> 3 months)","PATIENTS: Cancer in or around the eyes or ears; visual, hearing or cognitive impairment"],"whatHappens":"If you join, the listed intervention(s) are Interview, Medical Device Usage and Evaluation, or Questionnaire Administration. The registry lists allocation as randomized. This clinical trial tests how well a three-dimensional (3D) mindfulness virtual reality (VR) versus (vs) two-dimensional (2D) non-immersive interventions works in improving depression, anxiety, pain, and/or stress in patients with head and neck cancer (HNC) undergoing radiation or chemoradiation (C/RT), and their caregivers.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Duarte. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.322Z"},{"nctId":"NCT06986460","title":"Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression","officialTitle":"Low Frequency Right Dorsolateral Pre Frontal Cortical Repetitive TMS for Bipolar Depression","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Tyler Kaster","sponsorClass":"OTHER","summary":"The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering. Participants will come for 30 days of LFR, with a 6-week follow-up period. Symptoms of depression (for determining treatment efficacy) and mania (for determining treatment safety) will be assessed using the 17-item Hamilton Rating Scale for Depression (HRSD-17) and the Young Mania Rating Scale (YMRS) every five treatments during the treatment course, and at 1 week and 6 week after treatment completion.","conditions":["Bipolar Depression Depressed Phase"],"keywords":["rTMS","Bipolar Depression","treatment-resistant","LFR"],"interventions":[{"type":"DEVICE","name":"MagPro X100/R30 stimulator, Cool-B70 coil"}],"enrollment":80,"startDate":"2025-05-27","completionDate":"2030-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Must be deemed to have capacity to provide informed consent;\n2. Must be an outpatient;\n3. Have a DSM 5 diagnosis of bipolar disorder (type I or II), current episode depressed confirmed by Mini-International Neuropsychiatric Interview version 7.0.2 (MINI) assessed during TRIBE trial participation with no contradictory evidence that the current episode is depressed from FLARE trial screening assessments (YMRS\\>10/PHQ-9 \\<10);\n4. older than 18 years;\n5. failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17.\n6. Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;\n7. ≤3 months from completion of the TRIBE study;\n8. not currently experiencing a mixed or manic episode (YMRS ≤10);\n9. no increase or initiation of psychotropic medication with intention of treating depressive symptoms in the 4 weeks prior to screening. This excludes targeted treatment of insomnia with trazodone, melatonin, low-dose doxepin \\[3-6mg\\], low-dose benzodiazepines \\[≤2mg lorazepam daily equivalent\\], non-benzodiazepine benzodiazepine receptor agonists, or orexin antagonists;\n10. currently receiving treatment with one of the following non-anticonvulsant mood stabilizer with evidence for prevention of mania: lithium, quetiapine, asenapine, aripiprazole, paliperidone (\\>6mg), risperidone, olanzapine, ziprasidone, haloperidol, clozapine (lurasidone and cariprazine are excluded due to lack of evidence for preventing mania);\n11. able to adhere to the treatment schedule;\n12. pass the TMS adult safety screening questionnaire.\n\nExclusion Criteria:\n\n1. have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;\n2. have a concomitant major unstable medical illness;\n3. have active suicidal intent;\n4. are pregnant or intend to get pregnant during the study;\n5. have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;\n6. have psychotic symptoms within the current episode;\n7. have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;\n8. failure of an adequate acute course of ECT as defined by ATHF-SF during the current episode;\n9. have any clinically significant neurological disorder (e.g., recent major cerebrovascular accident), or any history of seizure except those therapeutically induced by ECT or with clear precipitant (e.g., febrile seizure of childhood, alcohol withdrawal, etc.);\n10. have any intracranial implant (e.g., aneurysm clips, shunts, stimulators,) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n11. if participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the study;\n12. have a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators;\n13. are currently taking lorazepam ≥2 mg daily (or equivalent) due to the potential to limit rTMS efficacy;\n14. are currently taking, any dose of an anticonvulsant due to the potential to limit rTMS efficacy;\n15. if anticonvulsants have been discontinued prior to screening, at least 5 half-lives have elapsed until screening to allow sufficient drug clearance;\n16. have a non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).\n17. participant was withdrawn from the TRIBE study due to safety concerns or at the discretion of the PI.\n18. any history of substance use in the last 4 weeks which poses a safety concern to undergo rTMS as assessed by the PI's review of responses to the trial's 'Substance Use Screening Questions Form'.","locations":[{"facility":"University Health Network Toronto Western Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre For Addiction and Mental Health (CAMH)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hannah Taalman","phone":"416-535-8501","email":"Hannah.taalman@camh.ca"},{"name":"Mawahib Semeralul","phone":"416-535-8501","email":"mawahib.semeralul@camh.ca"}],"primaryOutcomes":["Change on the 17-item Hamilton Rating Scale for Depression (HRSD-17)"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 3: MagPro X100/R30 stimulator, Cool-B70 coil for Bipolar Depression Depressed Phase","inPlainEnglish":"The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC. This work will develop the evidence supporting the use of LFR rTMS for individuals with treatment-resistant BD-DE who currently have limited treatment options to alleviate their suffering.","whoItsFor":["Ages 18 Years to any","Must be an outpatient;","older than 18 years;","failure to achieve a clinical response within the TRIBE study (CTO#: 4343) defined as ≤50% response from baseline to 6 weeks on the HRSD-17","Score ≥10 on PHQ-9 at both (i) the 6 weeks follow-up in the TRIBE trial and (ii) at screening;","≤3 months from completion of the TRIBE study;","not currently experiencing a mixed or manic episode (YMRS ≤10);","able to adhere to the treatment schedule;"],"whoShouldSkip":["have a history of MINI diagnosis of a substance use disorder (other than nicotine and/or caffeine) within the last 3 months;","have a concomitant major unstable medical illness;","have active suicidal intent;","are pregnant or intend to get pregnant during the study;","have a lifetime MINI diagnosis of schizophrenia or schizoaffective disorder;","have psychotic symptoms within the current episode;","have a MINI anxiety disorder, trauma-related disorder, obsessive compulsive disorder, or personality disorder assessed by a study investigator to be primary and/or causing greater impairment than BD-DE;"],"whatHappens":"If you join, the listed intervention(s) are MagPro X100/R30 stimulator, Cool-B70 coil. The registry lists allocation as na. The purpose of this trial is to conduct an adequately powered clinical trial of once daily LFR for individuals diagnosed with treatment-resistant BD-DE who have not responded to iTBS or sham treatment applied to the left DLPFC.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 80 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.747Z"},{"nctId":"NCT06988319","title":"Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study","officialTitle":"Psilocybin for Chronic Pelvic Pain (CPP) in Women: A Pilot Feasibility Study","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Oregon Health and Science University","sponsorClass":"OTHER","summary":"The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).","conditions":["Chronic Pelvic Pain"],"keywords":["psilocybin","women","chronic pelvic pain","psilocybin assisted therapy"],"interventions":[{"type":"DRUG","name":"Psilocybin (Usona Institute)"}],"enrollment":15,"startDate":"2026-11-01","completionDate":"2027-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Assigned female at birth, age 18-45 years (pre-menopause)\n* CPP for at least 6 months or longer with central sensitization, diagnosed by a provider who specializes in CPP (e.g. MD, DO, NP)\n* CPP with central sensitization includes endometriosis, adenomyosis, uterine fibroids, pelvic congestion, other pelvic inflammatory diseases, irritable bowel syndrome, inflammatory bladder disorders, myalgias, or any combination of the aforementioned1,3\n* Failing at least 1 treatment for CPP. Failed conventional interventions include pharmacotherapy, non-pharmacotherapy (bladder installations, neuromodulation, trigger point injections, anesthetic blocks, surgery), physical therapy, and/or psychotherapy (e.g. Cognitive Behavioral Therapy)\n* Participants will be generally healthy with no exclusionary physical or mental health conditions.\n\nExclusion Criteria:\n\n* Pelvic pain that is not defined as chronic (e.g. acute pelvic or vaginal infections such as sexually transmitted infections, urinary tract infections, pregnancy)\n* Have a history of or a current primary psychotic disorder or bipolar disorder type 1\n* Current use of lithium.\n* Ketamine-assisted therapy within 12 weeks of the baseline visit (V3) or hallucinogen use within 6 months of study enrollment (e.g. psilocybin at a dose of 10 mg or 1 gram mushroom or greater, LSD, MDMA, DMT)\n* Cannabis use (THC, CBD). If willing to taper before the baseline visit (V3) the participant can be included.\n* A positive urine drug test for illicit substance use\n* a score of 5 or greater on the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) indicating heavy alcohol use\n* Suicidal ideation or serious suicide risk as determined by C-SSRS, if baseline score is 4 or greater.\n* Uncontrolled hypertension, cardiovascular disease, chronic neurologic disorders (e.g. Parkinson's disease, dementia, multiple sclerosis, epilepsy)\n* Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation","locations":[{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lynne H Shinto, ND, MPH","phone":"(503) 494-5035","email":"shintol@ohsu.edu"},{"name":"Jacquelyn Knapp, MD","phone":"(510) 299-7662","email":"knapja@ohsu.edu"}],"primaryOutcomes":["Recruitment and Retention Feasibility","Acceptability","Number of participants with treatment related adverse events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["portland-oregon"],"enrichment":{"headline":"Phase 1: testing Psilocybin (Usona Institute) for Chronic Pelvic Pain","inPlainEnglish":"The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).","whoItsFor":["Ages 18 Years to 45 Years","Women only","Assigned female at birth, age 18-45 years (pre-menopause)","CPP for at least 6 months or longer with central sensitization, diagnosed by a provider who specializes in CPP (e.g. MD, DO, NP)","CPP with central sensitization includes endometriosis, adenomyosis, uterine fibroids, pelvic congestion, other pelvic inflammatory diseases, irritable bowel syndrome, inflammatory bladder disorders, myalgias, or any combination of the aforementioned1,3","you would be generally healthy with no exclusionary physical or mental health conditions"],"whoShouldSkip":["Pelvic pain that is not defined as chronic (e.g. acute pelvic or vaginal infections such as sexually transmitted infections, urinary tract infections, pregnancy)","Have a history of or a current primary psychotic disorder or bipolar disorder type 1","Current use of lithium","Ketamine-assisted therapy within 12 weeks of the baseline visit (V3) or hallucinogen use within 6 months of study enrollment (e.g. psilocybin at a dose of 10 mg or 1 gram mushroom or greater, LSD, MDMA, DMT)","Cannabis use (THC, CBD). If willing to taper before the baseline visit (V3) the participant can be included","A positive urine drug test for illicit substance use","a score of 5 or greater on the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) indicating heavy alcohol use"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (Usona Institute). The registry lists allocation as na. The primary aim is to determine the feasibility of enrolling and 15 women with chronic pelvic pain (CPP) that have failed one conventional for CPP to obtain preliminary safety data on a single administration of a moderate dose of pharmaceutical grade psilocybin (25 mg) in combination with psychotherapy sessions (two pre-dose preparatory and three post-dose integration sessions).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at Portland. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.101Z"},{"nctId":"NCT06989112","title":"DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer","officialTitle":"DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.","conditions":["Endometrial Cancer"],"keywords":["Endometrial Cancer","Uterine Cancer","Endometrial Carcinoma","Human epidermal growth factor receptor 2 (HER2)","pMMR","Trastuzumab deruxtecan","T-DXd","DS-8201a","Anti-HER2-Antibody Drug Conjugate(ADC)","DESTINY-Endometrial01","Programmed Cell Death-1 (PD1, PD-1)","Immune checkpoint inhibitor","TIGIT","Pembrolizumab","Carboplatin","Paclitaxel","Rilvegostomig"],"interventions":[{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Rilvegostomig"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Docetaxel"}],"enrollment":600,"startDate":"2025-03-27","completionDate":"2029-01-19","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* ≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations.\n* Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed).\n* Participant must have primary advanced disease (Stage III/IV) or recurrent endometrial cancer and meet at least one of the following criteria:\n\n  1. Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment.\n  2. Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline.\n  3. Recurrent disease regardless of presence of measurable disease at baseline.\n* Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing.\n* Endometrial cancer that is determined pMMR by prospective central testing.\n* Provision of an adequate FFPE tumor tissue sample for central HER2, MMR, and PD-L1 IHC testing.\n* Prior therapy:\n\n  1. No prior chemotherapy for the treatment of EC, except for one prior line of adjuvant/ neoadjuvant chemotherapy with curative intent (chemotherapy or chemoradiation) if completed ≥ 6 months prior to signature of the main ICF. Prior trastuzumab in the adjuvant/neoadjuvant setting is allowed.\n  2. No prior exposure to antibody-drug conjugates or immune checkpoint inhibitors\n  3. Participants may have received prior radiation therapy for the treatment of endometrial cancer. Adequate treatment washout period is required\n  4. Participants may have received prior hormonal therapy for the treatment of endometrial cancer. Adequate treatment washout period is required\n* ECOG 0-1.\n* Left ventricular ejection fraction ≥ 50% within 28 days before randomization.\n* Adequate organ and bone marrow function within 14 days before randomization.\n* The participant is not considered a candidate for curative therapy in the judgment of the investigator.\n\nKey Exclusion Criteria:\n\n* Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol.\n* Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment.\n* Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.\n* History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n* Lung criteria:\n\n  1. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, etc.).\n  2. Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening.\n  3. Prior pneumonectomy (complete).\n* History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis.\n* History of organ transplant or allogeneic stem cell transplant.\n* Spinal cord compression or clinically active central nervous system metastases. Participants with clinically inactive brain metastases may be included in the study.\n* Evidence of any of the following infections:\n\n  1. Active tuberculosis\n  2. HIV infection that is not well controlled.\n  3. 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Site","city":"Liestal","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changhua","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bath","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Northwood","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taunton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Progression-free survival (PFS), as assessed by BICR"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":["pembrolizumab","trastuzumab-deruxtecan"],"locationSlugs":["tucson-arizona","little-rock-arkansas","duarte-california","irvine-california","la-jolla-california","palo-alto-california","san-francisco-california","sylmar-california","fort-myers-florida","miami-florida","miami-beach-florida","orlando-florida","st-petersburg-florida","tampa-florida","west-palm-beach-florida","augusta-georgia","honolulu-hawaii","arlington-heights-illinois","evanston-illinois","shreveport-louisiana","baltimore-maryland","silver-spring-maryland","boston-massachusetts","worcester-massachusetts","ann-arbor-michigan","detroit-michigan","marshall-minnesota","minneapolis-minnesota","rochester-minnesota","jackson-mississippi","springfield-missouri","st-louis-missouri","las-vegas-nevada","lebanon-new-hampshire","hackensack-new-jersey","albuquerque-new-mexico","new-york-new-york","charlotte-north-carolina","winston-salem-north-carolina","cincinnati-ohio","columbus-ohio","oklahoma-city-oklahoma","tulsa-oklahoma","eugene-oregon","abington-pennsylvania","hershey-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","providence-rhode-island","charleston-south-carolina","sioux-falls-south-dakota","austin-texas","fort-worth-texas","houston-texas","san-antonio-texas","charlottesville-virginia","fairfax-virginia","seattle-washington","madison-wisconsin","blacktown-australia","east-melbourne-australia","nedlands-australia","south-brisbane-australia","innsbruck-austria","linz-austria","vienna-austria","wein-austria","anderlecht-belgium","brussels-belgium","charleroi-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","barretos-brazil","belo-horizonte-brazil","goi-nia-brazil","londrina-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","salvador-brazil","s-o-paulo-brazil","teresina-brazil","calgary-canada","edmonton-canada","winnipeg-canada","halifax-canada","london-canada","toronto-canada","montreal-canada","qu-bec-canada","beijing-china","changchun-china","changsha-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","haikou-china","hangzhou-china","harbin-china","hefei-china","jinan-china","jining-china","kunming-china","lanzhou-china","nanchang-china","nanning-china","shanghai-china","shantou-china","shenyang-china","taiyuan-china","tianjin-china","r-mqi-china","wuhan-china","xian-china","xuzhou-china","yibin-china","aalborg-denmark","herlev-denmark","k-benhavn-denmark","odense-denmark","helsinki-finland","oulu-finland","tampere-finland","turku-finland","besan-on-france","bordeaux-france","caen-france","clermont-ferrand-france","lyon-france","montpellier-france","nice-france","paris-france","pl-rin-france","poitiers-france","saint-herblain-france","toulouse-france","berlin-germany","chemnitz-germany","dessau-germany","dresden-germany","d-sseldorf-germany","essen-germany","hamburg-germany","kassel-germany","kiel-germany","leipzig-germany","mannheim-germany","marburg-germany","m-nchen-germany","m-nster-germany","saarbr-cken-germany","budapest-hungary","debrecen-hungary","catania-italy","florence-italy","milan-italy","monza-italy","naples-italy","reggio-emilia-italy","roma-italy","rome-italy","torino-italy","turin-italy","akashi-shi-japan","ginowan-shi-japan","hidaka-shi-japan","isehara-shi-japan","kashiwa-japan","kashiwa-shi-japan","kobe-japan","k-toku-japan","kurume-shi-japan","matsuyama-japan","morioka-japan","nagoya-japan","niigata-japan","osaka-japan","ota-shi-japan","sapporo-japan","sendai-japan","shinjuku-ku-japan","sunto-gun-japan","tokyo-japan","yokohama-japan","amsterdam-netherlands","leiden-netherlands","nijmegen-netherlands","rotterdam-netherlands","oslo-norway","stavanger-norway","bialystok-poland","gdansk-poland","lodz-poland","poznan-poland","siedlce-poland","szczecin-poland","goyang-si-south-korea","seoul-south-korea","suwon-south-korea","a-coru-a-spain","c-rdoba-spain","donostia-san-sebastian-spain","el-palmar-spain","lhospitalet-de-llobregat-spain","madrid-spain","palma-de-mallorca-spain","valencia-spain","zaragoza-spain","link-ping-sweden","lund-sweden","stockholm-sweden","uppsala-sweden","frauenfeld-switzerland","liestal-switzerland","sankt-gallen-switzerland","zurich-switzerland","changhua-taiwan","kaohsiung-city-taiwan","new-taipei-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","bath-united-kingdom","cambridge-united-kingdom","leeds-united-kingdom","london-united-kingdom","manchester-united-kingdom","northwood-united-kingdom","taunton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Trastuzumab deruxtecan for Endometrial Cancer","inPlainEnglish":"DESTINY-Endometrial01 will investigate the how well it works of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.","whoItsFor":["Ages 18 Years to any","Women only","≥ 18 years of age at the time of screening. Other age restrictions may apply as per local regulations","Histologically confirmed diagnosis of epithelial endometrial carcinoma. All histologies are allowed except for sarcomas (carcinosarcomas are allowed)","Participant must have primary advanced disease (Stage III/IV) or recurrent endometrial cancer and meet at least one of the following criteria:","Primary Stage III (per FIGO 2023) disease with measurable disease at baseline per RECIST 1.1 based on the investigator's assessment","Primary Stage IV (per FIGO 2023) disease regardless of presence of measurable disease at baseline","Recurrent disease regardless of presence of measurable disease at baseline","Endometrial cancer with HER2 IHC expression of 3+ or 2+ by prospective central testing"],"whoShouldSkip":["Any severe or uncontrolled systemic diseases which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or would jeopardize compliance with the protocol","Active or ongoing serious chronic gastrointestinal conditions associated with diarrhea, primary immunodeficiency, or non-infectious skin disease requiring systemic treatment","Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs","History of (non-infectious) ILD/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening","Any autoimmune, connective tissue or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of screening","Prior pneumonectomy (complete)","History of myocardial infarction or unstable angina within 6 months before randomization, or symptomatic congestive heart failure (NYHA Class II to IV), clinically significant arrhythmia, uncontrolled hypertension, cardiomyopathy of any etiology or history of myocarditis"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab deruxtecan, Rilvegostomig, or Pembrolizumab. The registry lists allocation as randomized. DESTINY-Endometrial01 will investigate the how well it works of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 230 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.365Z"},{"nctId":"NCT06991361","title":"Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD","officialTitle":"A Phase I Trial of Ex Vivo-Expanded (EVE) Regulatory T Cells in Combination With Low-Dose Interleukin-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Sarah Nikiforow, MD","sponsorClass":"OTHER","summary":"Hematopoietic Stem Cell Transplant (HCT) has been used to treat children and adults who have leukemia, lymphoma and other cancers of blood and immune cells since the 1970s. For many of these forms of cancer, HCT works well. However, HCT can cause serious, sometimes life-threatening complications.\n\nOne of the most serious and common complications of HCT is graft-versus-host disease (GVHD). GVHD can appear early after the transplant, usually about 3 to 4 weeks after the transplant is given. This is called acute GVHD (aGVHD), because it usually happens over a couple of days. If successfully treated, acute GVHD quickly goes away. Sometimes GVHD happens months after the transplant. Then it is called chronic GVHD (cGVHD), because it happens gradually and goes away slowly.\n\nThe investigators are doing this study to see if one dose of Ex vivo-Expanded Regulatory T cells (EVE-Treg) can be used together with the daily Interleukin 2 (IL-2) to treat cGVHD, that has not responded to steroid treatment or low-dose IL-2.","conditions":["Graft Versus Host Disease (cGvHD)"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"EVE-Treg"}],"enrollment":21,"startDate":"2026-05-29","completionDate":"2029-05-01","sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation.\n* Age 2 and up.\n* Must have steroid-refractory chronic GVHD that is still active despite at least 4 weeks of treatment with low-dose subcutaneous (SC) IL-2.\n* Stable dose of glucocorticoids for 2 weeks prior to enrollment\n* no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment.\n* Must have adequate organ and marrow function.\n* Ability to understand and willingness to sign a written informed consent form.\n* Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg.\n\nExclusion Criteria:\n\n* Recipient of umbilical cord blood stem cell graft.\n* Ongoing prednisone requirement greater than 1 mg/kg/day (or equivalent).\n* Karnofsky/Lansky performance score less than 40%.\n* Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus.\n* Other investigational agents within 4 weeks prior to enrollment.\n* Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days prior to enrollment.\n* Participants with new immunosupprssive medication, extra-corporeal photopheresis or rituximab therapy initiated int he 4 weeks prior to enrollment.\n* Participants with active malignant relapse or recrudescence of their prior hematologic disorder.\n* Uncontrolled intercurrent illness unrelated to cGVHD.\n* Participants with psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant patients are excluded.","locations":[{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brandi Bratrude","phone":"617-919-2197","email":"brandi.bratrude@childrens.harvard.edu"}],"primaryOutcomes":["Safety of EVE-Treg"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 1: testing EVE-Treg for Graft Versus Host Disease (cGvHD)","inPlainEnglish":"Hematopoietic Stem Cell Transplant (HCT) has been used to treat children and adults who have leukemia, lymphoma and other cancers of blood and immune cells since the 1970s. For many of these forms of cancer, HCT works well.","whoItsFor":["Ages 2 Years to any","Recipient of 7-8/8 HLA-matched allogeneic hematopoietic stem cell transplantation or recipient of haploidentical allogenic hematopoietic stem cell transplantation","Must have steroid-refractory chronic GVHD that is still active despite at least 4 weeks of treatment with low-dose subcutaneous (SC) IL-2","Stable dose of glucocorticoids for 2 weeks prior to enrollment","no addition or subtraction of other immunosuppressive medications for 4 weeks prior to enrollment","Must have adequate organ and marrow function","Donor who is willing and cleared to donate starting material for manufacture of EVE-Treg"],"whoShouldSkip":["Recipient of umbilical cord blood stem cell graft","Ongoing prednisone requirement greater than 1 mg/kg/day (or equivalent)","Karnofsky/Lansky performance score less than 40%","Concurrent use of methotrexate, azathioprine, or a calcineurin-inhibitor plus sirolimus","Other investigational agents within 4 weeks prior to enrollment","Participants with post-transplant exposure to donor lymphocyte infusion, or T-cell or IL-2 targeted medications within 100 days prior to enrollment","Participants with new immunosupprssive medication, extra-corporeal photopheresis or rituximab therapy initiated int he 4 weeks prior to enrollment"],"whatHappens":"If you join, the listed intervention(s) are EVE-Treg. The registry lists allocation as randomized. Hematopoietic Stem Cell Transplant (HCT) has been used to treat children and adults who have leukemia, lymphoma and other cancers of blood and immune cells since the 1970s.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 21 people at Boston. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.659Z"},{"nctId":"NCT06992440","title":"Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension","officialTitle":"Empagliflozin to Improve Right Ventricular Function in Pulmonary Arterial Hypertension","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Gustavo A Heresi, MD, MS","sponsorClass":"OTHER","summary":"Randomized, triple-masked, parallel arm clinical trial of empagliflozin versus placebo in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.","conditions":["Pulmonary Arterial Hypertension"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG"},{"type":"DRUG","name":"Placebo"}],"enrollment":78,"startDate":"2025-06-26","completionDate":"2030-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* In order to be eligible to participate in this study, an individual must meet all the following criteria:\n\n  1. Provision of signed and dated informed consent form\n  2. Ability and stated willingness to comply with all study procedures and availability for the duration of the study\n  3. Ability to read and write in English\n  4. Male or female, aged 18 years or older, with group 1 PAH, idiopathic, heritable, associated with drugs and toxins, associated with connective tissue disease and with congenital heart disease (simple repaired or unrepaired defects) according to the current guidelines and adjudicated by the local PI\n  5. PAH confirmed by right heart catheterization in the last 5 years\n  6. RV dysfunction defined as FAC ≤ 40.0% on echocardiography performed during the screening visit. In PVDOMICS, FAC has a strong correlation with CMR RV ejection fraction; group 1 PAH patients with an FAC ≤ 40% (mean 27.0 ± 8.0%) had a mean RV ejection fraction of 35.5 ± 11.3% CMR RV ejection fraction ≤ 54% classifies PAH as intermediate (37-54%) or high (\\<37%) risk under current guidelines. However, to ensure we recruit patients with significantly impaired RV function, patients with RV FAC between 35.0-40.0% on the screening echocardiogram will have to meet at least one of the following additional criteria: a) TAPSE/sPAP ratio \\< 0.31 mm/mmHg; b) elevated right atrial pressure defined as inferior vena cava (IVC) \\> 2.1 cm in diameter and the IVC does not collapse with sniff/respiration; c) RV enlargement defined as RV basal diameter ≥ 4.1 cm; d) RV free wall longitudinal strain ≥ -22%; e) Interventricular septal flattening; and f) RV outflow tract mid or late systolic notching.\n  7. On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no clinical plans to change this therapy.\n  8. Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician.\n  9. Ability to take oral medication and willingness to adhere to the study drug regimen.\n  10. For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of study drug administration\n  11. Able to have baseline and week 24 CMR according to Imaging Core criteria, as adjudicated by the Site PI\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  1. Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor\n  2. Use of an SGLT2 inhibitor within the past 3 months prior to screening\n  3. Prior documented inability to tolerate an SGLT2 inhibitor\n  4. Volume depletion, as ascertained by the site PI, at screening or baseline\n  5. History of diabetic ketoacidosis or type 1 diabetes mellitus\n  6. Chronic alcohol or drug abuse\n  7. More than one bacterial or yeast genitourinary tract infection in the year prior to enrollment\n  8. Estimated glomerular filtration rate under 30 mL/minute/1.73m2 or on renal replacement therapy\n  9. Pregnancy or lactation\n  10. Known allergy or hypersensitivity to empagliflozin or another SGLT-2 inhibitor\n  11. Currently taking or has taken another investigational drug within the past 4 weeks\n  12. Enrollment in another randomized intervention trial. (Participants participating in observational trials will not be excluded).\n  13. Decompensated right heart failure, as adjudicated by the site PI.\n  14. Screening HbA1c \\>10% with symptoms such as polyuria and polydipsia","locations":[{"facility":"The Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gustavo Heresi, MD","phone":"216 636-5327","email":"HERESIG@ccf.org"},{"name":"Erica Corrao, MS","phone":"216 347-4515","email":"corraoe2@ccf.org"}],"primaryOutcomes":["Change in RV ejection fraction measured by CMR"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":["empagliflozin"],"locationSlugs":["baltimore-maryland","cleveland-ohio","nashville-tennessee"],"enrichment":{"headline":"Phase 2: testing Empagliflozin 10 MG for Pulmonary Arterial Hypertension","inPlainEnglish":"Randomly assigned, triple-masked, parallel arm clinical trial of empagliflozin versus dummy treatment (placebo) in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.","whoItsFor":["Ages 18 Years to any","In order to be eligible to participate in this study, an individual must meet all the following criteria:","Ability and stated willingness to comply with all study procedures and availability for the duration of the study","Ability to read and write in English","PAH confirmed by right heart catheterization in the last 5 years","On FDA-approved PAH-targeted therapy (any combination including infused prostacyclin analogues and sotatercept) with stable doses for at least 8 weeks or 24 weeks for sotatercept prior to the screening visit and no clinical plans to change this therapy","Diuretic doses stable for at least 4 weeks prior to screening. After screening, diuretic doses may be changed as directed by the site PIs and/or the treating physician","Ability to take oral medication and willingness to adhere to the study drug regimen"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Current use of insulin, insulin secretagogues (sulfonylureas and meglitinides), lithium or an SGLT2 inhibitor","Use of an SGLT2 inhibitor within the past 3 months prior to screening","Prior documented inability to tolerate an SGLT2 inhibitor","Volume depletion, as ascertained by the site PI, at screening or baseline","History of diabetic ketoacidosis or type 1 diabetes mellitus","Chronic alcohol or drug abuse"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG, or Placebo. The registry lists allocation as randomized. Randomly assigned, triple-masked, parallel arm clinical trial of empagliflozin versus dummy treatment (placebo) in pulmonary arterial hypertension (PAH) participants on stable approved PAH-targeted medical therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 78 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.622Z"},{"nctId":"NCT06992804","title":"Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease","officialTitle":"The Efficacy and Safety of Near-Infrared Light Therapy Combined With Lecanemab for Mild Alzheimer's Disease","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Xuanwu Hospital, Beijing","sponsorClass":"OTHER","summary":"The goal of this study is to explore the efficacy and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD).\n\nThis study will employ a randomized, double-blind, sham-controlled method with an open-label extension phase. This trial contains the core phase and an extension phase. During the core phase, eligible subjects were selected and randomized (experimental group: control group = 1:1). The subjects who entered the experimental group received treatment with a near-infrared light therapy device combined with lecanemab for 16 weeks. The subjects who entered the control group received treatment with a near-infrared light therapy device simulator (sham stimulation) combined with lecanemab for 16 weeks. After completing the core phase, patients from both groups of the core phase are eligible to enter the extension phase. In the extension phase, all the participants were treated with a near-infrared light therapy device combined with lecanemab up to week 48.","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"OTHER","name":"NirsCure with Lecanemab"},{"type":"OTHER","name":"sham NirsCure with Lecanemab"},{"type":"OTHER","name":"NirsCure with Lecanemab"}],"enrollment":20,"startDate":"2025-05-28","completionDate":"2025-10-15","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age between 50 and 90 years old, gender unrestricted;\n2. Meet the core clinical diagnostic criteria for probable Alzheimer's disease as defined by the National Institute on Aging and the Alzheimer's Association (2011 NIA-AA);\n3. Amyloid positivity confirmed by Amyloid PET;\n4. Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;\n5. Mini-Mental State Examination (MMSE) score ≥ 15;\n6. Participants must have an educational level of primary school or above and be capable of completing the cognitive assessments and other tests as specified in the protocol;\n7. If taking cognition-enhancing medications, the dosage must have been stable for at least 12 weeks prior to enrollment (psychotropic drug dosage stable for at least 4 weeks);\n8. The participant or their guardian voluntarily agrees to participate and signs the informed consent form.\n9. For caregivers, the following requirements must be met: They need to be stable and have the ability to read. A minimum of 1 hour of daily interaction with the participant is necessary. Throughout the study, they are expected to assist in completing the informant sections of the scale assessments. Additionally, they should be willing to help the participant use the near-infrared light therapy device. Finally, they must understand and agree to the study procedures.\n\nExclusion Criteria:\n\n1. Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);\n2. APOE genotype of ε4/ε4;\n3. More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;\n4. Currently taking anticoagulant medications;\n5. History of epilepsy or hemorrhagic stroke within the past 12 months;\n6. Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;\n7. Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);\n8. Malignant tumors;\n9. Any unstable and uncontrolled medical conditions (such as severe cardiac, respiratory, gastrointestinal, renal diseases), or conditions that the investigator deems may affect the safety of the patient or interfere with trial assessments;\n10. Contraindications to PET or MRI, including claustrophobia, cardiac pacemaker/defibrillator, ferromagnetic metal implants, etc.;\n11. Currently receiving anti-amyloid treatment for Alzheimer's disease with severe adverse reactions such as cerebral hemorrhage or cerebral edema;\n12. Alcohol or drug addiction;\n13. Pregnant, breastfeeding, or planning to become pregnant;\n14. Participation in another clinical study within one month prior to this trial;\n15. Other situations deemed by the investigator as unsuitable for participation in the clinical study.\n16. For caregivers, the following exclusion criterion applies: They must not have severe neurological or psychiatric disorders.","locations":[{"facility":"Xuanwu Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yi Tang, MD, PhD","phone":"00861083199456","email":"tangyi@xwhosp.org"},{"name":"Liyang Liu, MD","phone":"00861083192332","email":"slioliu@pku.edu.cn"}],"primaryOutcomes":["The change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog)."],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Early phase 1: NirsCure with Lecanemab for Alzheimer Disease","inPlainEnglish":"The goal of this study is to explore the how well it works and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD). This study will employ a randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled method with an open-label extension phase.","whoItsFor":["Ages 50 Years to 90 Years","Age between 50 and 90 years old, gender unrestricted;","Meet the core clinical diagnostic criteria for probable Alzheimer's disease as defined by the National Institute on Aging and the Alzheimer's Association (2011 NIA-AA);","Amyloid positivity confirmed by Amyloid PET;","Clinical Dementia Rating - Global Score (CDR-GS) rating = 1;","Mini-Mental State Examination (MMSE) score ≥ 15;","Participants must have an educational level of primary school or above and be capable of completing the cognitive assessments and other tests as specified in the protocol;","If taking cognition-enhancing medications, the dosage must have been stable for at least 12 weeks prior to enrollment (psychotropic drug dosage stable for at least 4 weeks);"],"whoShouldSkip":["Cognitive impairment or dementia due to any cause other than Alzheimer's disease, or severe psychiatric disorders (schizophrenia, bipolar disorder, severe depression, etc.);","APOE genotype of ε4/ε4;","More than 5 cerebral microbleeds in the cerebral cortex as indicated by MRI within the last three months;","Currently taking anticoagulant medications;","History of epilepsy or hemorrhagic stroke within the past 12 months;","Allergy to sunlight or visible light, or high sensitivity of the skin on the head and neck;","Severe head trauma or presence of implanted devices (bone screws, bone plates, surgical removals, etc.);"],"whatHappens":"If you join, the listed intervention(s) are NirsCure with Lecanemab, sham NirsCure with Lecanemab, or NirsCure with Lecanemab. The registry lists allocation as randomized. The goal of this study is to explore the how well it works and safety of near-infrared light combined with lecanemab in patients with mild Alzheimer's disease (AD).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.233Z"},{"nctId":"NCT06993675","title":"Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)","officialTitle":"Improving MRD Negativity Rates in Newly Diagnosed Multiple Myeloma Patients: a Response-adaptive Approach of Consolidation With One or Two Bispecific T-cell Engagers Against GPRC5D or BCMA","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Noffar Bar","sponsorClass":"OTHER","summary":"Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction and transplant have worse prognosis than those with MRD negative disease.\n\nBispecific T-cell-based immunotherapies have the potential to promote further reduction of malignant plasma cells thus improving rates of MRD negativity and improve patient outcomes. In this study, participants who are MRD positive after front line therapy will receive consolidation with GPRC5D-targeted bispecific talquetamab. We will test MRD negative conversion and if MRD negativity was not achieved, the participant will switch to a different target using the B-cell maturation antigen TCE, teclistamab. Consolidation will be continued for up to 1 year in participants who have achieved MRD negativity. After consolidation therapy on this protocol is complete, participants may continue to be treated with standardof- care (SOC) maintenance therapy.","conditions":["Multiple Myeloma"],"keywords":["minimal residual disease","ROTATE"],"interventions":[{"type":"DRUG","name":"Talquetamab"},{"type":"DRUG","name":"Teclistamab"}],"enrollment":50,"startDate":"2025-08-21","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nTo qualify for participation in this study, an individual must satisfy each of the following criteria:\n\n1. Provision of signed and dated ICF.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female aged 18 years or older.\n4. Newly diagnosed multiple myeloma participants who are transplant eligible and have completed at least four cycles of quadruplet, anti-CD38 antibody-based induction and have received HDM ASCT within 60-120 days. If consolidation with the same induction regimen is used post ASCT, enrolment up to 60 days post consolidation.\n5. Must have MRD positive disease at 10-5 based on NGS with a PR or better response.\n6. Must not be progressing as per IMWG criteria\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status Scale of 0 or 1. ECOG 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy. Adequate bone marrow function:\n\n   1. Hemoglobin 8 g/dl (³5mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted).\n   2. Absolute neutrophil count ≥1.0×109/L (prior growth factor support is permitted but must be without support for 7 days for G-CSF or GM-CSF and for 14 days for pegylated-G-CSF).\n   3. Platelets ³75×109/L (without transfusion support or thrombopoietin receptor agonist within 7 days before the laboratory test).\n8. Estimated creatinine clearance ≥30 mL/min based on the Cockcroft-Gault Equation (see https://www.mdcalc.com/calc/43/creatinine-clearance-cockcroft-gault-equation)\n9. Must have adequate liver function:\n\n   1. Aspartate aminotransferase ≤2.5 folds of the upper limit of normal (ULN).\n   2. Alanine aminotransferase ≤2.5 folds of the ULN.\n   3. Serum bilirubin ≤ 1.5 x ULN (except in participants with congenital bilirubinemia, such as Gilbert syndrome where must be \\<5xULN).\n10. Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and for the specified duration after the last dose of talquetamab or teclistamab:\n\n    1. For participants receiving talquetamab, these criteria apply for three months after the last dose.\n    2. For participants receiving teclistamab, these criteria apply for five months for those assigned female at birth and three months for those assigned male at birth.\n    3. General Requirements:\n\n    i. Participants must not be pregnant or breastfeeding. ii. Participants must not donate gametes (i.e., eggs or sperm) or freeze gametes for future use related to assisted reproduction.\n\n    d. For participants of childbearing potential: Participant of childbearing potential is defined as an individual who is premenopausal and capable of becoming pregnant, including those using contraception, those who are single, or those with partners who have had a vasectomy.\n\nii. A negative highly sensitive pregnancy test must be obtained at screening within 24 hours before the first dose of talquetamab (first study treatment), and participants must agree to further pregnancy tests throughout the study.\n\niii. Participants must practice at least one highly effective method of contraception.\n\ne. For Partners of Participants: i. If the participant's partner is of childbearing potential, the partner must also practice a highly effective method of contraception while the participant is on study treatment and for three months after the last dose of talquetamab or the last dose of teclistamab, unless the participant is vasectomized.\n\nf. Highly effective methods of contraception include, but are not limited to: i. Combined hormonal contraception (estrogen and progestogen) that inhibits ovulation (oral, intravaginal, or transdermal).\n\nii. Progestogen-only hormonal contraception that inhibits ovulation (oral, injectable, or implantable).\n\niii. Intrauterine device (IUD). iv. Intrauterine hormone-releasing system. v. Bilateral tubal occlusion. vi. Sexual abstinence (the reliability of abstinence must be evaluated concerning the duration of the clinical study and the participant's lifestyle).\n\nvii. A vasectomized partner (provided the partner is the sole sexual partner of the WOCBP study participant and that the vasectomized partner has received medical confirmation of the surgical success).\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Prior or concurrent exposure to any of the following within the specified timeframe before first dose of study drug:\n\n   1. Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less.\n   2. Investigational vaccine within four weeks.\n   3. Monoclonal antibody therapy within 21 days.\n   4. Cytotoxic therapy within 14 days.\n   5. PI therapy within 14 days.\n   6. IMiD agent therapy within 14 days.\n   7. Radiotherapy within 14 days or focal radiation within seven days.\n   8. Gene-modified adoptive cell therapy (e.g., NK cells) within three months.\n   9. Prior exposure to a bispecific T-cell engager or CAR T-cell therapy.\n2. An active or suspected infection at time of screening. For rescreening refer to section 5.5.\n3. Known history or serologic evidence of human immunodeficiency virus (HIV) infection.\n4. Known history, virologic, or serological evidence of hepatitis B or C virus (HBV/HCV) infection; participants who had HCV but have received an antiviral treatment and show no detectable HCV viral RNA for six months are eligible. Participants with no active hepatitis B infection (e.g., HBsAg negative, anti-HBcAb positive) who are under adequate prophylaxis per local standard of care against HBV reactivation may be eligible.\n5. Class III or IV congestive heart failure.\n6. Presence of clinically relevant CNS pathology.\n7. Another active malignancy that requires treatment.\n8. Pregnancy or lactation.\n9. Known allergic reactions to components of talquetamab or teclistamab.\n10. Received a cumulative dose of corticosteroids equivalent to ≥140 mg of prednisone within 14 days before first dose of study drug.\n11. Received a live, attenuated vaccine within four weeks before the first dose of study drug.\n12. Plasma cell leukemia, smoldering multiple myeloma, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M-protein, and skin changes), or primary light chain amyloidosis.\n13. Any active malignancy (i.e., progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured:\n\n    1. Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, \\<3 cm, no CIS).\n    2. Non-melanoma skin cancers treated with curative therapy or localized melanoma treated with curative surgical resection alone.\n    3. Non-invasive cervical cancer.\n    4. Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ or history of localized breast cancer (anti-antihormonal therapy is permitted).\n    5. Localized prostate cancer (M0, N0) with a Gleason Score ≤7a, treated locally only (RP/RT/focal treatment).\n    6. Other malignancy that is considered cured with minimal risk of recurrence in consultation with the sponsor-investigator.\n\n    NOTE: In the event of any questions, consult with the sponsor-investigator prior to enrolling a participant.\n14. Stroke, transient ischemic attack or seizure within six months prior to enrolment.\n15. Presence of the following cardiac conditions:\n\n    1. New York Heart Association stage III or IV congestive heart failure (Appendix 5: New York Heart Association Functional Classification).\n    2. Myocardial infarction, unstable angina, or coronary artery bypass graft ≤6 months prior to randomization.\n    3. History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration.\n    4. Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.\n16. Major surgery within two weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within two weeks after administration of the last dose of study treatment.\n\n    NOTE: Participants with planned surgical procedures to be conducted under local anesthesia may participate. Kyphoplasty or vertebroplasty are not considered major surgery. If there is a question whether a procedure is considered a major surgery, the investigator must consult with the appropriate sponsor representative and resolve any issues before enrolling a participant in the study.\n17. Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:\n\n    1. Acute diffuse infiltrative pulmonary disease\n    2. Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy\n    3. Active autoimmune disease requiring systemic immunosuppressive therapy within six months before start of study treatment. Exception: Participants with vitiligo, controlled type I diabetes, and prior autoimmune thyroid disease that is currently euthyroid based on clinical symptoms and laboratory testing are eligible regardless of when these conditions were diagnosed.\n    4. Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status\n    5. Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n    6. History of noncompliance with recommended medical treatments.","locations":[{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carole Ramm","phone":"203-785-5702","email":"carole.ramm@yale.edu"}],"primaryOutcomes":["Rate of MRD Negative Response at 10^-5 Sensitivity Using NGS ClonoSEQ Assay in Participants with Newly Diagnosed Multiple Myeloma Treated with Talquetamab Consolidation With or Without Sequential Teclistamab by 12 Months"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","omaha-nebraska","rochester-new-york"],"enrichment":{"headline":"Phase 2: testing Talquetamab for Multiple Myeloma","inPlainEnglish":"Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction and transplant have worse prognosis than those with MRD negative disease.","whoItsFor":["Ages 18 Years to any","To qualify for participation in this study, an individual must satisfy each of the following criteria:","Provision of signed and dated ICF","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female aged 18 years or older","Must have MRD positive disease at 10-5 based on NGS with a PR or better response","Must not be progressing as per IMWG criteria","Hemoglobin 8 g/dl (³5mmol/L; without prior RBC transfusion within 7 days before the laboratory test; recombinant human erythropoietin use is permitted)"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Prior or concurrent exposure to any of the following within the specified timeframe before first dose of study drug:","Targeted therapy, epigenetic therapy, or treatment with an investigational drug or an invasive investigational medical device within 21 days or ≥5 half-lives, whichever is less","Investigational vaccine within four weeks","Monoclonal antibody therapy within 21 days","Cytotoxic therapy within 14 days","PI therapy within 14 days"],"whatHappens":"If you join, the listed intervention(s) are Talquetamab, or Teclistamab. The registry lists allocation as na. Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.487Z"},{"nctId":"NCT06995898","title":"The Vanguard Study: Testing a New Way to Screen for Cancer","officialTitle":"The Vanguard Study: Testing a New Way to Screen for Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomized controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously. There is a need to understand how MCDs may work as cancer screening tools. The goal of cancer screening is to reduce the burden of cancer by identifying cancers before they show symptoms or signs, when treatment is likely to be most effective. In this study, adults aged 45-75 without cancer will be randomly assigned to one of 3 groups: 2 separate MCD test groups or a control group. These two MCD tests will not be compared to each other but will be compared to cancers detected in the control group. This study will provide early information on how well MCD tests perform as cancer screening tools. It will also help researchers understand how patients and their doctors make decisions about their care when the MCD test result comes back as normal (negative) or abnormal (positive).","conditions":["Bladder Carcinoma","Breast Carcinoma","Colorectal Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Liver Carcinoma","Lung Carcinoma","Malignant Solid Neoplasm","Ovarian Carcinoma","Pancreatic Carcinoma","Prostate Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DEVICE","name":"Device Usage"},{"type":"OTHER","name":"Electronic Health Record Review"},{"type":"PROCEDURE","name":"Multi-Cancer Early Detection Test"},{"type":"PROCEDURE","name":"Multi-Cancer Early Detection Test"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":24000,"startDate":"2025-06-18","completionDate":"2029-01-31","sex":"ALL","minAge":"45 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Ages 45-75 years old\n* Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment\n* Agree to allow collection of information from their medical records for study-related purposes\n* Understand and be able to complete informed consent and participant questionnaires in English, Spanish, or Arabic\n\n  * Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion\n\nExclusion Criteria:\n\n* Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years\n\n  * Note: Persons with a history of in situ cancers (e.g., ductal carcinoma in situ of the breast, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ) or nonmelanoma skin cancer are eligible. Persons with a history of prostate cancer that has not been treated are not eligible, regardless of when the diagnosis occurred\n* Ongoing cancer diagnostic work-up\n* Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice\n* Currently breastfeeding or pregnant, or planning to become pregnant in the next year\n* History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days","locations":[{"facility":"Kaiser Permanente-Division of Research","city":"Pleasanton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Naval Medical Center -San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keefe Memorial Hospital","city":"Cheyenne Wells","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Franklin","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poudre Valley Hospital","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care and Hematology-Fort Collins","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Greeley Hospital","city":"Greeley","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Rock Creek","city":"Lafayette","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Lone Tree","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center of the Rockies","city":"Loveland","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Moanalua Medical Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Walter Reed National Military Medical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Cancer Institute-Downriver","city":"Brownstown","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health Center - Brownstown","city":"Brownstown","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health Center - Chesterfield","city":"Chesterfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Macomb Hospital-Clinton Township","city":"Clinton Township","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center-Fairlane","city":"Dearborn","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Detroit Northwest","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center-Cottage","city":"Grosse Pointe Farms","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Livonia","city":"Livonia","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center-Columbus","city":"Novi","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Plymouth","city":"Plymouth","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Royal Oak","city":"Royal Oak","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center","city":"Sterling Heights","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Troy","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford West Bloomfield Hospital","city":"West Bloomfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Wyandotte Hospital","city":"Wyandotte","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis VA Medical Center","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Hospital of Kansas City","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CoxHealth South Hospital","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Lineberger Comprehensive Cancer Center","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Durham VA Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Louis Stokes Cleveland VA Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sentara Martha Jefferson Hospital","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Fair Oaks Hospital","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sentara Norfolk General Hospital","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Naval Medical Center - Portsmouth","city":"Portsmouth","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Cancer Center at Stony Point","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Community Memorial Health Center","city":"South Hill","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Madigan Army Medical Center","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zablocki Veterans Administration Medical Center","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Feasibility of enrollment onto study","Proportion of participants who complete baseline and follow-up questionnaires within 60 days of receipt","Proportion of participants who provide the required blood sample for year 1 for Multi-Cancer Detection (MCD) testing within 90 days of recommended time point","Proportion of participants considered lost to follow-up within 2 years of randomization","Representative enrollment","Staggered start of intervention arm 2"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["pleasanton-california","san-diego-california","cheyenne-wells-colorado","denver-colorado","fort-collins-colorado","greeley-colorado","lafayette-colorado","lone-tree-colorado","loveland-colorado","honolulu-hawaii","bethesda-maryland","brownstown-michigan","chesterfield-michigan","clinton-township-michigan","dearborn-michigan","detroit-michigan","grosse-pointe-farms-michigan","livonia-michigan","novi-michigan","plymouth-michigan","royal-oak-michigan","sterling-heights-michigan","troy-michigan","west-bloomfield-michigan","wyandotte-michigan","minneapolis-minnesota","kansas-city-missouri","springfield-missouri","st-louis-missouri","chapel-hill-north-carolina","durham-north-carolina","cleveland-ohio","oklahoma-city-oklahoma","charlottesville-virginia","fairfax-virginia","norfolk-virginia","portsmouth-virginia","richmond-virginia","south-hill-virginia","tacoma-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Biospecimen Collection for Bladder Carcinoma","inPlainEnglish":"The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomly assigned controlled trial. An MCD test measures markers in the blood in order to screen for multiple cancers simultaneously.","whoItsFor":["Ages 45 Years to 75 Years","Ages 45-75 years old","Agree to provide blood samples for possible MCD testing at enrollment and at 1 year following enrollment","Agree to allow collection of information from their medical records for study-related purposes","Note: Eligibility for Spanish and Arabic languages are at the Hub's discretion"],"whoShouldSkip":["Solid malignant tumor or blood cancer diagnosis, with or without treatment, within the last 5 years","Ongoing cancer diagnostic work-up","Ongoing participation in another study of an investigational cancer screening test or technology not currently utilized in routine clinical practice","Currently breastfeeding or pregnant, or planning to become pregnant in the next year","History of solid organ or hematopoietic transplantation at any time, or blood transfusion within the last 30 days"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Device Usage, or Electronic Health Record Review. The registry lists allocation as randomized. The Vanguard Study is a feasibility study to explore several aspects of evaluating multi-cancer detection (MCD) tests in a future definitive randomly assigned controlled trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24,000 people at 46 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.319Z"},{"nctId":"NCT06996119","title":"Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant","officialTitle":"Pilot Study of Emapalumab With Post-Transplant Cyclophosphamide as Graft-Versus-Host Disease Prophylaxis for Reduced-Intensity Allogeneic Hematopoietic Cell Transplantation","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \\[peripheral blood stem cell\\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. When healthy stem cells for a donor are infused into a patient (allogeneic HCT), they may help the patient's bone marrow make more healthy cells and platelets. Allogeneic HCT is an established treatment, however, GVHD continues to be a major problem of allogeneic HCT that can complicate therapy. GVHD is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Emapalumab binds to an immune system protein called interferon gamma. This may help lower the body's immune response and reduce inflammation. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill cancer cells. It may also lower the body's immune response. Tacrolimus is a drug used to help reduce the risk of rejection by the body of organ and bone marrow transplants. Mycophenolate mofetil is a drug used to prevent GVHD after organ transplants. It is also being studied in the prevention of GVHD after stem cell transplants for cancer, and in the treatment of some autoimmune disorders. Mycophenolate mofetil is a type of immunosuppressive agent. Giving emapalumab with post-transplant cyclophosphamide, tacrolimus and mycophenolate mofetil may be safe, tolerable and/or effective in preventing GVHD in patients with AML or MDS after a reduced-intensity allogeneic HCT.","conditions":["Acute Myeloid Leukemia","Graft Versus Host Disease","Myelodysplastic Syndrome"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Busulfan"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"BIOLOGICAL","name":"Emapalumab"},{"type":"DRUG","name":"Fludarabine"},{"type":"PROCEDURE","name":"Hematopoietic Cell Transplantation"},{"type":"DRUG","name":"Melphalan"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Mycophenolate Mofetil"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"DRUG","name":"Tacrolimus"}],"enrollment":15,"startDate":"2026-06-12","completionDate":"2028-11-05","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented informed consent of the participant and/or legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Age: ≥ 18 years and ≤ 75 years\n\n  * Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80% and HCT-comorbidity index (CI) ≤ 2\n* Karnofsky performance status ≥ 70%\n* Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in complete remission with bone marrow (BM) blast of \\< 5%. AML must be negative for minimal residual disease (MRD-)\n* Planned to undergo reduced-intensity conditioning (RIC) with either fludarabine/melphalan (Flu/Mel) or busulfan/fludarabine (Bu/Flu) regimens prior to an allogeneic HCT using a mobilized peripheral blood stem cell (PBMC) graft from an 8/8 match related/unrelated donor (A, B, C, DR by high resolution typing)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)\n* Aspartate aminotransferase (AST) ≤ 3.0 x ULN\n* Alanine aminotransferase (ALT) ≤ 3.0 x ULN\n* Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 30 days prior to day 1 of protocol therapy\n* Bazett's correction formula (QTcB) ≤ 480 ms\n* If able to perform pulmonary function tests: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and diffusion capacity of the lung for carbon monoxide (DLCO) (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin).\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n* Seronegative for HIV antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n* Meets other institutional and federal requirements for infectious disease titer requirements\n\n  * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* QuantiFERON-TB Gold+\n\n  * Administer tuberculosis prophylaxis to patients at risk for tuberculosis, or known to have a positive purified protein derivative (PPD) test result, or positive interferon gamma (IFNγ) release assay\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 180 days post-HCT\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Prior allogeneic HCT\n* Other cancer therapies (chemotherapy, radiation, biologics) are not allowed within two weeks of starting HCT conditioning; however targeted agents for underlying hematologic malignancies may be continued up to one day before conditioning, including, but not limited to:\n\n  * FLT3 inhibitors\n  * IDH1/2 inhibitors\n  * Menin inhibitors\n  * ABL-BCR inhibitors\n  * BCL-2 inhibitors\n  * Hydroxyurea\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Psychological issues, no appropriate caregivers identified, or non-compliant to medication\n* Clinically significant uncontrolled illness\n* Active uncontrolled infections (bacterial, viral, fungal). Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, no signs of infection are present\n* Other active malignancy\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of grade 3 or higher adverse events (AEs)","Incidence of severe infusion reaction","Incidence of primary graft failure","Non-relapse mortality (NRM)"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Busulfan for Acute Myeloid Leukemia","inPlainEnglish":"This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT). Giving chemotherapy, such as fludarabine, melphalan, or busulfan, before a donor \\[peripheral blood stem cell\\] transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.","whoItsFor":["Ages 18 Years to 75 Years","Assent, when appropriate, will be obtained per institutional guidelines","Age: ≥ 18 years and ≤ 75 years","Note: Patients \\> 70 years of age must have Karnofsky performance status ≥ 80% and HCT-comorbidity index (CI) ≤ 2","Karnofsky performance status ≥ 70%","Patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) in complete remission with bone marrow (BM) blast of \\< 5%. AML must be negative for minimal residual disease (MRD-)","Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (unless has Gilbert's disease)","Aspartate aminotransferase (AST) ≤ 3.0 x ULN"],"whoShouldSkip":["Prior allogeneic HCT","Other cancer therapies (chemotherapy, radiation, biologics) are not allowed within two weeks of starting HCT conditioning; however targeted agents for underlying hematologic malignancies may be continued up to one day before conditioning, including, but not limited to:","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent","Psychological issues, no appropriate caregivers identified, or non-compliant to medication","Clinically significant uncontrolled illness","Active uncontrolled infections (bacterial, viral, fungal). Infections are considered controlled if appropriate therapy has been initiated and, at the time of screening, no signs of infection are present","Other active malignancy"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Busulfan, or Computed Tomography. The registry lists allocation as na. This phase I trial tests the safety, side effects and effectiveness of emapalumab with post-transplant cyclophosphamide, tacrolimus, and mycophenolate mofetil in preventing graft-versus-host disease (GVHD) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after reduced-intensity donor (allogeneic) hematopoietic cell transplant (HCT).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at Duarte. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.821Z"},{"nctId":"NCT06996652","title":"An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)","officialTitle":"An Exploratory Study of the Potential for Rational Immune System Manipulation to Prevent Emergence of Synucleinopathy Manifestations in Persons With REM Sleep Behavior Disorder (RBD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"This is a phase 2 study to assess the ability of adalimumab as compared to placebo to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.","conditions":["REM Sleep Behavior Disorder"],"keywords":["Parkinson Disease Related Pattern","adalimumab","Synucleinopathy"],"interventions":[{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":108,"startDate":"2026-08-17","completionDate":"2029-08-01","sex":"ALL","minAge":"50 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Males, or females who are either\n\n  1. post-menopausal or otherwise not of child-bearing potential, defined as either 1) having had no menses for 12 or months without an alternative medical cause or explanation or 2) having undergone a surgical procedure (hysterectomy, bilateral tubal ligation) that prevents conception, or\n  2. practicing adequate contraception. Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from 30 days before baseline (or earlier) through at least 150 days after the last dose of the study drug. Female participants of non-childbearing potential do not need to use birth control.\n  3. women of childbearing potential must have a negative urine pregnancy test prior to enrollment, and agree to undergo a pregnancy test at each study visit. Women with a positive pregnancy test at screening or at any subsequent study visit will be withdrawn from the study.\n* Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:\n\n  1. History of Dream Enactment Behavior during sleep and\n  2. Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD\n* Hyposmia, defined as score \\< 15th percentile for age-and gender-specific normal values\n* Not diagnosed with motor Parkinson's Disease or Lewy Body Dementia\n* Have a MoCA score at screening and baseline ≥23\n* Able to speak, read and write fluently in the official language of the site's geographical region\n* Participant must be willing and able to attend all study visits as required by the study protocol\n* Participant must have a study partner who is in regular contact with the subject and can accompany the subject to clinic visits and report on subject's functional status\n* Participant must be able to self-inject study drug regularly or have a study partner who is available, willing and able to do so\n* Participant must be able to understand the study requirements and provide written informed consent\n\nExclusion Criteria:\n\n* Women who are pregnant, planning to become pregnant, or currently breastfeeding\n* Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)\n* Other than RBD, neurologic or medical disorder which may impair cognition including: head trauma, seizure disorder, neurodegenerative disease, hydrocephalus, cerebral/spinal hematoma, inflammatory disease, CNS infection (e.g., encephalitis or meningitis), neoplasm, toxic exposure, metabolic disorder (including hypoxic or hypoglycemic episodes), or endocrine disorder, or any significant medical conditions that, in the opinion of the investigator, would prohibit their participation in the study.\n* As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3\n* Any contra-indication to undergo MRI, as judged by local PI or radiologist, including but not limited to presence of pacemaker, aneurysm clips, artificial heart valves, ear implants, ventriculoperitoneal shunt, foreign metal objects in the eyes, skin or body or any other circumstance which would contra-indicate an MRI scan or impair MRI image quality, or history of claustrophobia or of not tolerating MRI scanning procedures\n* History or active presence of any of the following neurological, psychiatric or medical conditions:\n\n  1. Large vessel stroke\n  2. Peripheral or CNS demyelinating disease\n  3. Chronic and/or recurrent fungal, bacterial or opportunistic infections\n  4. Myocardial infarction or unstable angina within the previous 12 months\n  5. Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) \\> 450 msec (males) or \\> 470 msec (females).\n  6. Congestive heart failure, NYHA Class 3 or 4\n  7. Autoimmune disease (e.g., Systemic Lupus Erythematosis (SLE), or symptoms suggestive of a lupus-like syndrome, multiple sclerosis, rheumatoid arthritis, Type 1 diabetes mellitus, inflammatory bowel disease, psoriasis, etc.)\n  8. Immunocompromised systemically due to continuing effects of immune suppressing medication\n  9. Current or previous hepatitis B infection (defined as positive test for hepatitis B surface antigen (HbSAg) and/or hepatitis B core antibody (anti-HBc).\n* Participants with immunity to hepatitis B (if due to natural infection defined as negative HBsAg, positive hepatitis B antibody (anti-HBs) and positive anti-HBc; if due to vaccination defined as negative HBsAg, negative anti-HBc and positive anti-HBs are eligible to participate in the study\n* For patients with resolved HBV infection, if anti-HBc negative, HBV DNA testing is needed prior to initiating study drug j. History or positive test at Screening for hepatitis C virus antibody (anti-HCV) in the absence of treatment resulting in cure k. History or positive test at Screening for human immunodeficiency virus (HIV) l. History of untreated or incompletely treated tuberculosis or a positive tuberculosis IGRA test.\n\n  m. History of malignancy other than successfully treated, non-metastatic cutaneous squamous or basal cell carcinoma or localized carcinoma in situ of the cervix n. Major depressive episode requiring initiation of medication or hospitalization within the previous 90 days o. Seated blood pressure \\> 150/90 on 3 separate determinations p. Presence of hallucinations or delusions q. Psychiatric disorder (schizophrenia, schizoaffective disorder, etc.) associated with psychosis r. Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baseline s. Major surgery within 12 weeks of screening t. Blood donation of 1 unit or more within 8 weeks prior to the first dose of study medication\n* Any of the following laboratory abnormalities at Screening\n\n  1. Screening values for hemoglobin \\< 12 g/d for men or \\< 11 g/dL for women or other clinically significant hematological abnormality\n  2. Any serum chemistry value (e.g., AST, ALT, alkaline phosphatase, CK, total bilirubin etc. \\> 2x the upper limit of normal on 2 successive determinations less than 2 weeks apart\n  3. Serum creatinine above the ULN or eGFR \\< 60 mL/min/1.73 m2\n  4. Platelet count, INR, PT or PTT not within the normal range or other risk for increased or uncontrolled bleeding\n* Any other significant medical conditions that, in the opinion of the investigator, would prohibit participation in the study, including inability to tolerate the MRI scan\n* For participants agreeing to lumbar puncture: Presence of contra-indication to lumbar puncture as judged by local PI (e.g., known X-ray or other evidence of significant lumbar spine abnormalities or history of lumbar surgery with sequalae that would interfere with or pose risks from the procedure; platelet count below 50,000 cells/mL; need for anticoagulant or antiplatelet medications other than aspirin at a dose of \\< 100 mg/day or clopidogrel (see item 10 (g) below))\n* Taking any of the following medications:\n\n  1. Symptomatic anti-Parkinson agents, including but not limited to levodopa-containing preparations, dopamine agonists, monoamine oxidase inhibitors, amantadine, and adenosine receptor antagonists taken any time prior to the screening visit\n  2. Cognitive enhancing agents, including but not limited to acetylcholinesterase inhibitors and memantine taken any time prior to the screening visit\n  3. Stimulant medications, including but not limited to lisdexamphetamine, dextroamphetamine/amphetamine (Adderall) and methylphenidate taken at any time prior to the screening visit\n  4. Antipsychotic agents, including pimavanserin\n  5. Antidepressant medications whose dose has not been stable for at least 90 days\n  6. Use of any of the following medications within 12 months prior to Screening: Immunosuppressant medications, including chronic corticosteroids, anakinra and abatacept\n  7. Any previous use of injected or infused antibody therapies, including but not limited antibodies directed against TNF, anti-IL-6, natalizumab, rituximab, conventional or targeted DMARD agents\n  8. For participants agreeing to undergo lumbar puncture: Anticoagulant or anti-platelet medications including warfarin, heparinoids and direct coagulation factor inhibitors (e.g., apixaban, dabigatran, rivaroxaban) within 90 days of the planned first dose of study drug; either aspirin at a dose of \\<¬ 100 mg/day or clopidogrel at a dose of 75 mg/day, but use of both in combination is permitted.\n  9. Received any live vaccine, with the exception of non-replicating live viral vaccines such as Jynneos vaccine, within 30 days prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 70 days after the last dose of study drug.\n* History of an allergic reaction or significant sensitivity to adalimumab or constituents of the study drug (and its excipients) and/or other products in the same class\n* Participation in any other interventional clinical trial, or treatment with any investigational drug or investigational use of an approved therapy within 30 days (or 5 half-lives of such agent) prior to the first Screening visit.\n* History of drug or alcohol abuse within the last 5 years (including cannabis use disorder)\n* Positive urine drug test at screening\n* Unwillingness or inability to comply with study requirements, including self-administration of study medication, or history of noncompliance in prior clinical trials","locations":[{"facility":"Cedars Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Medicine","city":"North Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkinson's Disease & Movement Disorders Center of Boca Raton","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University School of Medicine","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Lou Ruvo Center for Brain Health - Las Vegas","city":"Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Weill Medical College of Cornell University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center- San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Neurological Institute-Hospital at McGill University","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erika Renkl","phone":"475-254-9169","email":"erika.renkl@yale.edu"},{"name":"Kathy Gerich","phone":"","email":"katherine_gerich@URMC.rochester.edu"}],"primaryOutcomes":["Change in Parkinson Disease Related Pattern (PDRP) expression"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":["adalimumab"],"locationSlugs":["los-angeles-california","aurora-colorado","north-haven-connecticut","boca-raton-florida","atlanta-georgia","baltimore-maryland","boston-massachusetts","minneapolis-minnesota","st-louis-missouri","las-vegas-nevada","lebanon-new-hampshire","new-york-new-york","portland-oregon","philadelphia-pennsylvania","charleston-south-carolina","san-antonio-texas","montreal-canada"],"enrichment":{"headline":"Phase 2: testing Adalimumab for REM Sleep Behavior Disorder","inPlainEnglish":"This is a phase 2 study to assess the ability of adalimumab as compared to dummy treatment (placebo) to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD). The Primary Endpoint will be change from baseline in expression of the Parkinson Disease Related Pattern (PDRP) will be assessed using change in 18-flurodeoxyglucose (FDG) Positron Emission Tomography (PET) imaging.","whoItsFor":["Ages 50 Years to 80 Years","Males, or females who are either","women of childbearing potential must have a negative urine pregnancy test prior to enrollment, and agree to undergo a pregnancy test at each study visit. Women with a positive pregnancy test at screening or at any subsequent study visit will be withdrawn from the study","Diagnosis of idiopathic REM Sleep Behavior Disorder (RBD) based upon:","History of Dream Enactment Behavior during sleep and","Evidence of REM sleep without muscle atonia based upon polysomnogram obtained in a qualified sleep laboratory, consistent with ICSD-3 Diagnostic Criteria for RBD","Hyposmia, defined as score \\< 15th percentile for age-and gender-specific normal values","Not diagnosed with motor Parkinson's Disease or Lewy Body Dementia"],"whoShouldSkip":["Women who are pregnant, planning to become pregnant, or currently breastfeeding","Alternative explanation or etiology for the presence of RBD (e.g. narcolepsy)","As assessed by the central reader, MRI evidence of (a) more than three lacunar infarcts, (b) territorial infarct or macroscopic hemorrhage, or (c) deep white matter lesions corresponding to a Fazekas score of 3","History or active presence of any of the following neurological, psychiatric or medical conditions:","Large vessel stroke","Peripheral or CNS demyelinating disease","Chronic and/or recurrent fungal, bacterial or opportunistic infections"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab, or Placebo. The registry lists allocation as randomized. This is a phase 2 study to assess the ability of adalimumab as compared to dummy treatment (placebo) to reduce or prevent progression of synuclein-related neurodegeneration in persons with idiopathic REM Sleep Behavior Disorder (RBD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 108 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.665Z"},{"nctId":"NCT06996730","title":"A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease","officialTitle":"A Double-Blind, Placebo-Controlled, Double-Dummy Study of Donanemab and RG6289 in PSEN1 E280A Mutation Carriers, and in Non-Randomized, Placebo-Treated Non-Carriers From the Same Kindred, to Evaluate the Efficacy and Safety of Donanemab, RG6289, or the Combination of Donanemab and RG6289, in the Treatment of Autosomal-Dominant Alzheimer's Disease","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"QUADRUPLE","sponsor":"Banner Health","sponsorClass":"OTHER","summary":"The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive placebo-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months. Amyloid PET scans will be conducted at screening, 9, and 18 months in Part 1. Participants who are at or below 11 CL at screening or reach complete amyloid plaque clearance as measured by florbetapir F18 PET (defined as ≤11 CL) at 9 months will initiate Part 2. Participants who are ≤11 CL at screening may delay their entry into Part 2 for up to 6 months at the discretion of the Investigator. All remaining participants will start Part 2 after completing 18 months (76 weeks) in Part 1 independent of amyloid results. Non-carriers will receive placebo in both Parts 1 and 2.\n\nIn Part 2, study participants who are mutation carriers will be randomized 1:1:1:1 in a full factorial design to receive either RG6289 + placebo-donanemab (RG6289 alone group), donanemab + placebo-RG6289 (donanemab alone group), the combination of RG6289 and donanemab (combination group), or placebo-RG6289 and placebo-donanemab (placebo group). All non-carriers will be assigned to the placebo group. CDR-GS at the end of Part 1 and the amyloid level using the last completed amyloid PET scan in Part 1 will be used for stratification. All study participants will participate in a double-dummy design for the duration of Part 2 receiving both an intravenous (IV) infusion at the required interval for the donanemab or matching placebo as well as a daily oral treatment of RG6289 or matching placebo.\n\nAn exploratory outcome of Part 1 is a comparison of the amyloid clearance between this ADAD cohort and historical controls using propensity score matching. The primary outcome in Part 2 is change from the start of Part 2 through the end of Part 2 in brain amyloid load in PSEN1 E280A mutation carriers as measured by amyloid PET imaging. Other endpoints will include fluid and imaging biomarkers and measures of cognition and functioning. The maximum study duration for any individual participant will be 3 years, not including the screening or follow-up periods","conditions":["Autosomal Dominant Alzheimers Disease","Early Onset Alzheimer Disease","Alzheimers Disease"],"keywords":["Dementia"],"interventions":[{"type":"DRUG","name":"Donanemab"},{"type":"DRUG","name":"RG6289"},{"type":"DRUG","name":"Donanemab placebo"},{"type":"DRUG","name":"RG6289 placebo"}],"enrollment":240,"startDate":"2026-07-08","completionDate":"2030-06-01","sex":"ALL","minAge":"25 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Membership in PSEN1 E280A mutation carrier kindred.\n* Agrees to conditions of, and is willing to undergo, genetic testing (e.g., APOE, PSEN1 E280A, and other genetic testing allowed by local regulatory requirements).\n* Males and females aged 25-65 inclusive.\n* Must meet one of the following criteria:\n\n  a. Determined to be cognitively normal as defined by an MMSE of ≥24 for participants with less than 9 years of education or MMSE of ≥26 for participants with 9 or more years of education. b. Or determined to have MCI with amnestic presentation as defined by:\n\n  1\\. Cognitive concern in the judgment of the Investigator, based in part on the: i. CERAD Word List: Recall \\<3 for participants with less than 9 years of education. ii. CERAD Word List: Recall \\<5 for participants with 9 or more years of education. iii. Preservation of independence in functional activities in the judgment of the Investigator. c. Or determined to have mild AD dementia as defined by:\n  1. Meets the 2011 National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD, and\n  2. Has a CDR-GS of 0.5 or 1, with the memory box score ≥0.5.\n\n     Exclusion Criteria:\n* Significant medical, psychiatric, or other neurological condition or disorder documented by history, physical, neurological, laboratory examinations that would place the participant at undue risk in the Investigator's judgment or impact the interpretation of efficacy.\n* History of stroke.\n* History of severe, clinically significant (persistent neurological deficit or structural brain damage) CNS trauma (e.g., cerebral contusion).\n* Current presence of bipolar disorder or other clinically significant major psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) or symptom (e.g., hallucinations, agitation, paranoia) that could affect the participant's ability to complete evaluations.\n* History of seizures (excluding febrile seizures of childhood, or other isolated seizure episodes that were not due to epilepsy in the judgment of the Investigator, and required at most time-limited anticonvulsant treatment, and which occurred more than 7 years prior to the screening visit).\n* Women who are pregnant or intend to become pregnant during the conduct of this study.\n* Women who are nursing infants or intend to nurse infants during the conduct of this study.\n* Known (or prior) hypersensitivity to donanemab, RG6289, or any excipients of RG6289.\n* History of or active inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis).\n* Medical history of malignancy in the past 5 years, with the following exceptions:\n\n  1. If considered to be cured or,\n  2. If not being actively treated with anti-cancer therapy or radiotherapy and, in the opinion of the Investigator, is not likely to require treatment in the ensuing 5 years and,\n  3. For prostate cancer or basal cell carcinoma, no significant progression over the previous 2 years.\n  4. In-situ cervix carcinoma that has been successfully treated.\n  5. Fully excised non-melanoma skin cancers or in-situ melanoma.\n* Any surgery or hospitalization during the 4 weeks prior to screening or pre-planned/scheduled during the study period that, in the opinion of the Investigator, may compromise eligibility to the study. The Medical Monitor is available to the Investigator to advise and answer any questions.\n* Inability to tolerate MRI procedures or contraindication to MRI, including, but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan, or any other clinical history or examination finding that, in the judgment of the Investigator, would pose a potential hazard in combination with MRI\n* Prior participation in an anti-amyloid therapy trial is allowed if it has been at least 1 year since the last study dose.\n* Any other investigational treatment, including anti-amyloid small molecules (i.e., BACEi and GSIs, other GSMs) within five half-lives or 16 weeks prior to screening (calculated from the last safety follow-up visit of the previous study), whichever is longer. Note: The participant may be eligible for this study if it can be documented that he/she was randomized to placebo","locations":[{"facility":"Neurosciences Group of Antioquia, University of Antioquia","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David Gordon, M.S.","phone":"(602) 839 - 6020","email":"David.Gordon@bannerhealth.com"}],"primaryOutcomes":["Part 1: Change in amyloid load as measured by centiloid (CL) [F18]Florbetapir-PET as biomarker endpoint","Part 2: Maintenance of Low Levels of Brain Amyloid as Measured by centiloid (Cl) [F18]Florbetapir-PET Following Combined Intervention of Donanemab and RG6289"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["medell-n-colombia"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Donanemab for Autosomal Dominant Alzheimers Disease","inPlainEnglish":"The study will be conducted in 2 blinded parts (Part 1 and Part 2). In Part 1, study participants who are mutation carriers will receive active donanemab and non-mutation carriers will receive dummy treatment (placebo)-donanemab for up to 18 months (76 weeks), with a minimum treatment period of 9 months.","whoItsFor":["Ages 25 Years to 65 Years","Membership in PSEN1 E280A mutation carrier kindred","Agrees to conditions of, and is willing to undergo, genetic testing (e.g., APOE, PSEN1 E280A, and other genetic testing allowed by local regulatory requirements)","Males and females aged 25-65 inclusive","Must meet one of the following criteria:","a. Determined to be cognitively normal as defined by an MMSE of ≥24 for participants with less than 9 years of education or MMSE of ≥26 for participants with 9 or more years of education. b. Or determined to have MCI with amnestic presentation as defined by:","Meets the 2011 National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD, and","Has a CDR-GS of 0.5 or 1, with the memory box score ≥0.5"],"whoShouldSkip":["Significant medical, psychiatric, or other neurological condition or disorder documented by history, physical, neurological, laboratory examinations that would place the participant at undue risk in the Investigator's judgment or impact the interpretation of how well it works","History of severe, clinically significant (persistent neurological deficit or structural brain damage) CNS trauma (e.g., cerebral contusion)","Women who are pregnant or intend to become pregnant during the conduct of this study","Women who are nursing infants or intend to nurse infants during the conduct of this study","Known (or prior) hypersensitivity to donanemab, RG6289, or any excipients of RG6289","History of or active inflammatory bowel disease (e.g., Crohn disease or ulcerative colitis)","Medical history of malignancy in the past 5 years, with the following exceptions:"],"whatHappens":"If you join, the listed intervention(s) are Donanemab, RG6289, or Donanemab placebo. The registry lists allocation as randomized. The study will be conducted in 2 blinded parts (Part 1 and Part 2).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 240 people at Medellín. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.499Z"},{"nctId":"NCT06997029","title":"A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors","officialTitle":"A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess BMS-986500 as monotherapy in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.","conditions":["Advanced Solid Tumor","Advanced Breast Cancer","Advanced Ovarian Cancer"],"keywords":["cancer","oncology","solid tumor"],"interventions":[{"type":"DRUG","name":"BMS-986500"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Fulvestrant"}],"enrollment":234,"startDate":"2025-08-01","completionDate":"2028-12-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be ≥ 18 years of age.\n* Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy.\n* Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n* Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1.\n* For Part 2A only, participants must have CCNE1-amplified ovarian cancer\n\nExclusion Criteria:\n\n* Participants must not have an active brain metastasis.\n* Participants must not have impaired cardiac function or clinically significant cardiac disease.\n* Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months.\n* Participants must not have Grade ≥ 2 peripheral neuropathy.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence St. Jude Medical Center","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marin Cancer Care","city":"Greenbrae","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0008","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0006","city":"Boston","state":"Massachusetts","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Cancer Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health-Cancer Institute","city":"New Hyde Park","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0011","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Dallas Fort Worth","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Odense Universitetshospital","city":"Odense","state":"Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copenhagen University Hospital","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Hirakata","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Koto-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Number of Participants With Dose Limiting Toxicities (DLTs)","Number of Participants With Adverse Events (AEs)","Number of Participants With Serious Adverse Events (SAEs)","Number of Participants With AEs Leading to Discontinuation","Number of Participants With TEAEs Leading to Death"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["birmingham-alabama","fullerton-california","greenbrae-california","la-jolla-california","newport-beach-california","aurora-colorado","boston-massachusetts","st-louis-missouri","lebanon-new-hampshire","buffalo-new-york","new-hyde-park-new-york","new-york-new-york","fort-worth-texas","san-antonio-texas","odense-denmark","copenhagen-denmark","kashiwa-japan","hirakata-japan","chuo-ku-japan","koto-ku-japan"],"enrichment":{"headline":"Phase 1: testing BMS-986500 for Advanced Solid Tumor","inPlainEnglish":"This study wants to assess BMS-986500 as this drug alone in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.","whoItsFor":["Ages 18 Years to any","Participants must be ≥ 18 years of age","Participants must have histologically confirmed diagnosis of a locally advanced, unresectable, or metastatic solid tumor malignancy","Participants must have a measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","Participants must have a stable Eastern Cooperative Oncology Group Performance Status of 0 or 1","For Part 2A only, participants must have CCNE1-amplified ovarian cancer"],"whoShouldSkip":["Participants must not have an active brain metastasis","Participants must not have impaired cardiac function or clinically significant cardiac disease","Participants must not have bleeding disorder or any history of clinically significant bleeding within the prior 3 months","Participants must not have Grade ≥ 2 peripheral neuropathy","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are BMS-986500, Palbociclib, or Fulvestrant. The registry lists allocation as randomized. This study wants to assess BMS-986500 as this drug alone in advanced solid tumors and as combination therapy in CDK4/6 inhibitor pre-treated advanced breast cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 234 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.722Z"},{"nctId":"NCT06997588","title":"EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)","officialTitle":"Study Assessing the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).","conditions":["PIK3CA-related Overgrowth Spectrum (PROS)"],"keywords":["PIK3CA-related overgrowth spectrum (PROS)","Alpelisib (BYL719)","Phase II","Adult","Pediatric","Adolescent"],"interventions":[{"type":"DRUG","name":"Alpelisib"}],"enrollment":140,"startDate":"2025-10-09","completionDate":"2029-01-29","sex":"ALL","minAge":"2 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Male or female participants aged ≥2 years at the time of informed consent/assent.\n2. Participants with diagnosis of PROS (according to Clinical Diagnostic Criteria for PROS proposed by Keppler Noreuil et al 2014) with symptomatic AND progressive overgrowth, who have syndromic disease or isolated features (with the exception of isolated macrodactyly, macrocephaly or epidermal nevus) at the time of informed consent/assent.\n3. Documented evidence of a somatic mutation(s) in the PIK3CA gene performed in local laboratories using a DNA-based test AND available archival tissue (if archival tissue sample is not available, a fresh biopsy should be performed, if it is not clinically contraindicated) at the time of informed consent/assent.\n4. Karnofsky (in participants \\>16 years of age at study entry) or Lansky (≤16 years of age at study entry) performance status index ≥50.\n5. PGI-S score of mild, moderate, severe, or very severe at screening.\n6. Adequate bone marrow and organ function.\n7. Presence of at least 1 PROS-related measurable lesion (longest diameter ≥2 cm) confirmed by BIRC assessment and associated with complaints, clinical symptoms or functional limitations affecting the participant's everyday life.\n\nKey Exclusion Criteria:\n\n1. Participant with only isolated macrodactyly, epidermal nevus/nevi and macroencephaly (the only clinical feature or a combination of any of three of them), in absence of other PROS-related lesions at the time of informed consent/assent.\n2. Previous treatment with alpelisib and/or any other phosphatidylinositol 3-kinase (PI3K) inhibitor(s) (except treatment attempt, defined as the attempt to treat PROS with any of PI3K inhibitors, with treatment duration less than 2 weeks and stopped at least 2 weeks prior to the first dose of study medication with alpelisib).\n3. Debulking or other major surgery performed within 3 months at the time of informed consent/assent.\n4. Radiation exposure for PROS treatment purpose within 12 months prior to informed consent/assent.\n5. Clinically meaningful PROS-related thrombotic event (Grade 2 and more as per CTCAE v4.03) within 15 days before study treatment initiation, and/or sclerotherapy/embolization for vascular complications performed within 6 weeks before informed consent/assent.\n6. Clinically meaningful bleeding from PROS-related lesion (Grade 2 and more as per CTCAE v4.03) within 15 days before study treatment initiation.\n7. Participants with clinically significant worsening of PROS-related laboratory abnormalities, physical signs and symptoms (such as, but not limited to increase of D-dimers, worsening of underlying pain, newly occurring swelling or redness) indicating an uncontrolled condition during the screening phase.\n\nOther inclusion/exclusion criteria may apply","locations":[{"facility":"Univ of California at Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cinn Children Hosp Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children s Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health Sciences University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hosp Pittsburgh UPMC","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College Of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Health Science Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hospital and Regional Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"North Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Salzburg","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Angers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Freiburg im Breisgau","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Düsseldorf","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Halle","state":"Saxony-Anhalt","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Stuttgart","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Roma","state":"RM","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Torino","state":"TO","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Trieste","state":"TS","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nijmegen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Esplugues","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Lausanne","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"}],"primaryOutcomes":["Proportion of participants with a confirmed objective response by BIRC"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["sacramento-california","washington-d-c-district-of-columbia","st-louis-missouri","chapel-hill-north-carolina","cincinnati-ohio","columbus-ohio","portland-oregon","pittsburgh-pennsylvania","houston-texas","seattle-washington","sydney-australia","north-adelaide-australia","salzburg-austria","vienna-austria","ghent-belgium","angers-france","bron-france","dijon-france","montpellier-france","paris-france","toulouse-france","tours-france","freiburg-im-breisgau-germany","d-sseldorf-germany","leipzig-germany","halle-germany","berlin-germany","stuttgart-germany","roma-italy","torino-italy","trieste-italy","nijmegen-netherlands","esplugues-spain","a-coru-a-spain","barcelona-spain","madrid-spain","lausanne-switzerland","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Alpelisib for PIK3CA-related Overgrowth Spectrum (PROS)","inPlainEnglish":"This study is designed to demonstrate the how well it works and assess whether it is safe and how hard side effects are to live with of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).","whoItsFor":["Ages 2 Years to 100 Years","Karnofsky (in participants \\>16 years of age at study entry) or Lansky (≤16 years of age at study entry) performance status index ≥50","PGI-S score of mild, moderate, severe, or very severe at screening","Adequate bone marrow and organ function","Presence of at least 1 PROS-related measurable lesion (longest diameter ≥2 cm) confirmed by BIRC assessment and associated with complaints, clinical symptoms or functional limitations affecting the participant's everyday life"],"whoShouldSkip":["Clinically meaningful bleeding from PROS-related lesion (Grade 2 and more as per CTCAE v4.03) within 15 days before study treatment initiation"],"whatHappens":"If you join, the listed intervention(s) are Alpelisib. The registry lists allocation as na. This study is designed to demonstrate the how well it works and assess whether it is safe and how hard side effects are to live with of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 140 people at 40 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.127Z"},{"nctId":"NCT06997809","title":"ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery","officialTitle":"ENDometriosis: Evaluation of Detection and Need for ALGOlogic Care Before Surgery","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University Hospital, Limoges","sponsorClass":"OTHER","summary":"Endometriosis surgery is required when medical treatment fails to release women from pain. However, complete surgery does not work every time to improve patients' symptoms. Algological care is one of the options to treat the pain before surgery and their related complications (neuropathy, sensitization, and catastrophism) that could be associated to nociceptive pain.\n\nBut not all patients could benefit from this pathway and no screening strategy does exist to detect these complications that could be treated prior to endometriosis surgery","conditions":["Endometriosis, Pain"],"keywords":["endometriosis, algologic care","pain, quality of life"],"interventions":[{"type":"OTHER","name":"pathway care"}],"enrollment":187,"startDate":"2026-08-05","completionDate":"2030-12","sex":"FEMALE","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Maternal age from 18 up to 50 years old (50 non included).\n* Women affiliated to social coverage insurance\n* Women who understand French\n* Women who signed the written consent\n* Women with impaired quality of life (pain) linked to endometriosis\n* Women with formal radiological signs of endometriosis (MRI lesions more than 5 mm or endometrioma more than 20 mm on radiological examinations).\n* Surgical indication for resection of lesions by laparoscopy or robotic surgery for management of pain or impairment of quality of life\n* Patients requiring complete conservative or radical resections of all lesions\n* Indication of surgery validated within dedicated meeting for endometriosis.\n* Purpose of pain associated or not with infertility\n* Date of surgery fixed with sufficient time for algological treatment. Maximum delay of 4 months between randomization and surgery\n\nExclusion criteria:\n\n* Women undergoing surgery for the purpose of infertility\n* Patient with previous surgery for removal of deep lesions of endometriosis or endometriotic cysts (history of exploratory laparoscopy accepted)\n* Patient with suspicious lesions on MRI or specialized ultrasound.\n* A patient who needs to be treated for another uterine pathology at the same time.\n* Pregnant women\n* Patient with a desire for pregnancy immediately and/or within one year after surgery\n* Women who refuse clinical examination (some algological tests couldn't be performed without clinical examination)\n* Patient who has already received algological treatment or who should receive it before surgery\n* Patient with previous other psychiatric disorders (depressive symptoms treated)\n* Women without rights","locations":[{"facility":"Bordeaux University Hospital","city":"Bordeaux","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IFEMENDO","city":"Bordeaux","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Versailles Hospital","city":"Le Chesnay","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Saint-Vincent-de-Paul Hospital","city":"Lille","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Limoges University hospital","city":"Limoges","state":"France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poissy-St-Germain Intercommunal hospital center","city":"Poissy","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Poitiers University Hospital","city":"Poitiers","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mutual Clinic La Sagesse","city":"Rennes","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"South Hospital Rennes University Hospital","city":"Rennes","state":"France","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Safirah AKOWANOU","phone":"+33555058755","email":"safirah.akowanou@chu-limoges.fr"},{"name":"Abdeslam BEN TALEB","phone":"+33555058616","email":"abdeslam.bentaleb@chu-limoges.fr"}],"primaryOutcomes":["Evaluation of quality of life"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["bordeaux-france","le-chesnay-france","lille-france","limoges-france","poissy-france","poitiers-france","rennes-france"],"enrichment":{"headline":"Not a traditional drug phase: pathway care for Endometriosis, Pain","inPlainEnglish":"Endometriosis surgery is required when medical treatment fails to release women from pain. However, complete surgery does not work every time to improve patients' symptoms.","whoItsFor":["Ages 18 Years to 50 Years","Women only","Maternal age from 18 up to 50 years old (50 non included)","Women affiliated to social coverage insurance","Women who understand French","Women who signed the written consent","Women with impaired quality of life (pain) linked to endometriosis","Women with formal radiological signs of endometriosis (MRI lesions more than 5 mm or endometrioma more than 20 mm on radiological examinations)","Surgical indication for resection of lesions by laparoscopy or robotic surgery for management of pain or impairment of quality of life"],"whoShouldSkip":["Women undergoing surgery for the purpose of infertility","Patient with previous surgery for removal of deep lesions of endometriosis or endometriotic cysts (history of exploratory laparoscopy accepted)","Patient with suspicious lesions on MRI or specialized ultrasound","A patient who needs to be treated for another uterine pathology at the same time","Patient with a desire for pregnancy immediately and/or within one year after surgery","Women who refuse clinical examination (some algological tests couldn't be performed without clinical examination)","Patient who has already received algological treatment or who should receive it before surgery"],"whatHappens":"If you join, the listed intervention(s) are pathway care. The registry lists allocation as randomized. Endometriosis surgery is required when medical treatment fails to release women from pain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 187 people at 9 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.115Z"},{"nctId":"NCT07000227","title":"Mechanism of FODMAP Restriction on FGID Patients","officialTitle":"Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Universiti Kebangsaan Malaysia Medical Centre","sponsorClass":"OTHER","summary":"Brief Summary :\n\nThe goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :\n\nHow does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.\n\nParticipants will :\n\nBe given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.\n\nBe required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention","conditions":["Functional Gastrointestinal Disorders (FGIDs)","Irritable Bowel Syndrome (IBS)","Functional Dyspepsia"],"keywords":["Functional Gastrointestinal Disorder","Irritable Bowel Syndrome","Functional Dyspepsia","FODMAP Restriction","Gentle FODMAP"],"interventions":[{"type":"BEHAVIORAL","name":"Low FODMAP diet"},{"type":"BEHAVIORAL","name":"Gentle FODMAP diet"},{"type":"BEHAVIORAL","name":"Traditional Dietary Advice"}],"enrollment":60,"startDate":"2025-07-20","completionDate":"2026-09-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18 and above\n* Able to provide informed consent\n* Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists\n* Meet the ROME III- Asian criteria for FGID\n* Able to communicate in Malay or English language\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis\n* Cancer of any kind\n* Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma\n* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine\n* Use of antibiotics in the preceding two weeks and/or in the past one month\n* Consumption of probiotics, prebiotics or fibre supplements in the past one month\n* Enteral feeding or texture modified diet patients\n* Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)\n* Shift workers (e.g. Nurse, doctors)","locations":[{"facility":"Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak","city":"Kuala Lumpur","state":"Kuala Lumpur","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shanthi Krishnasamy, Dr","phone":"+60182017116","email":"shanthikrishnasamy@ukm.edu.my"},{"name":"Jaysrina Mahalinga Moorthy","phone":"+60138372089","email":"P153921@siswa.ukm.edu.my"}],"primaryOutcomes":["Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity","Effect of FODMAP restrictions on Gut Barrier Function"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["kuala-lumpur-malaysia"],"enrichment":{"headline":"Not a traditional drug phase: Low FODMAP diet for Functional Gastrointestinal Disorders (FGIDs)","inPlainEnglish":"Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is : How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ?","whoItsFor":["Ages 18 Years to any","Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists","Meet the ROME III- Asian criteria for FGID","Able to communicate in Malay or English language"],"whoShouldSkip":["Pregnant or lactating women","History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis","Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma","Habitual use of opiate analgesics likely to alter bowel function e.g. morphine","Use of antibiotics in the preceding two weeks and/or in the past one month","Consumption of probiotics, prebiotics or fibre supplements in the past one month","Enteral feeding or texture modified diet patients"],"whatHappens":"If you join, the listed intervention(s) are Low FODMAP diet, Gentle FODMAP diet, or Traditional Dietary Advice. The registry lists allocation as randomized. Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Kuala Lumpur. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.437Z"},{"nctId":"NCT07002034","title":"RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses","officialTitle":"A Randomized, Double-Blind, Parallel-Group, Dose-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Adjustment Disorder in Patients With Cancer and Other Medical Illnesses","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Reunion Neuroscience Inc","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.","conditions":["Adjustment Disorder"],"keywords":["Cancer","Amyotrophic Lateral Sclerosis (ALS)","Multiple Sclerosis (MS)","Parkinson&amp;#39;s Disease (PD)","Idiopathic Pulmonary Fibrosis (IPF)","Depression","Anxiety","Psychiatric Distress"],"interventions":[{"type":"DRUG","name":"RE104 for Injection"}],"enrollment":100,"startDate":"2025-07-30","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a ≥4 week history of AjD as defined by DSM-5-TR with either depressed mood, or mixed anxiety and depressed mood confirmed by clinical interview with evidence that the AjD was instigated by one of the following medical illnesses (e.g., diagnosis, impact, management, recurrence, prognosis): Cancer, ALS, MS, PD or IPF\n* Is sufficiently ambulatory and capable of self care as necessary to complete study procedures\n* Has normal cognitive function\n* Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study\n* If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant\n* Is willing and able to comply with the conditions and requirements of the study\n\nExclusion Criteria:\n\n* Has a significant risk of suicide\n* Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder\n* Has a history of current active central nervous system malignancy\n* Has other medically significant conditions rendering unsuitability for the study\n* Has used or will need to use prohibited medications or therapies\n* Has a known sensitivity or intolerance to study intervention or potential rescue medications","locations":[{"facility":"UAB, Psychiatry and Behavioral Neurology","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arizona","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kadima Neuropsychiatry Institute","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida, Department of Psychiatry and Behavioral Neuroscience","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hawaii Pacific Neuroscience","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU Health Shreveport","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunstone Therapies, PC","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheppard Pratt","city":"Towson","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Massachusetts Chan Medical Center","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Novi","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico, School of Medicine","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Center Institute","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York State Psychiatric Institute","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University, Department of Psychiatry","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance for Multispecialty Research Clinical","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dell Medical School, University of Texas at Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Clinical Research Inc.","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UVA Center for Psychiatric Clinical Research","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Neuropsychiatric Treatment Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin at Madison","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mark Pollack, Chief Medical Officer","phone":"1-888-880-REUN","email":"info@reunionneuro.com"}],"primaryOutcomes":["RE104 30 mg versus RE104 1.5 mg change from baseline in MADRS total score"],"hasResults":false,"conditionSlugs":["parkinson","multiple-sclerosis","als","depression"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","tucson-arizona","san-diego-california","santa-rosa-california","aurora-colorado","tampa-florida","atlanta-georgia","honolulu-hawaii","chicago-illinois","kansas-city-kansas","shreveport-louisiana","rockville-maryland","towson-maryland","boston-massachusetts","worcester-massachusetts","ann-arbor-michigan","novi-michigan","omaha-nebraska","albuquerque-new-mexico","buffalo-new-york","new-york-new-york","chapel-hill-north-carolina","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","knoxville-tennessee","austin-texas","draper-utah","charlottesville-virginia","seattle-washington","madison-wisconsin"],"enrichment":{"headline":"Phase 2: testing RE104 for Injection for Adjustment Disorder","inPlainEnglish":"This study wants to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 80 Years","Is sufficiently ambulatory and capable of self care as necessary to complete study procedures","Has normal cognitive function","Is on stable use of antidepressants or psychotherapy, or is willing to delay use until the end of study","If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant","Is willing and able to comply with the conditions and requirements of the study"],"whoShouldSkip":["Has a significant risk of suicide","Has active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder","Has a history of current active central nervous system malignancy","Has other medically significant conditions rendering unsuitability for the study","Has used or will need to use prohibited medications or therapies","Has a known sensitivity or intolerance to study intervention or potential rescue medications"],"whatHappens":"If you join, the listed intervention(s) are RE104 for Injection. The registry lists allocation as randomized. This study wants to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at 33 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.722Z"},{"nctId":"NCT07003295","title":"Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy","officialTitle":"A Phase II Study of Glofitamab for Relapsed/Refractory Mantle Cell Lymphoma in Patients Previously Treated With CD19-Directed CAR T-Cell Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells. Glofitamab is a bispecific antibody that can bind to two different antigens at the same time. Glofitamab binds to CD3, a protein found on T cells (a type of white blood cell), and CD20 a protein found on B cells (another type of white blood cell) and some lymphoma cells. This may help the immune system kill cancer cells. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Giving glofitamab and obinutuzumab may be safe, tolerable, and/or effective in treating patients with relapsed or refractory mantle cell lymphoma after receiving CD19-directed CAR T-cell therapy.","conditions":["Recurrent Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"BIOLOGICAL","name":"Glofitamab"},{"type":"BIOLOGICAL","name":"Obinutuzumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"}],"enrollment":20,"startDate":"2026-07-08","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen)\n* Patients must have been previously treated with an anti-CD19 CAR T-cell therapy and have failed or been intolerant to Bruton's tyrosine kinase (BTK) inhibition. Both commercial and investigational CAR-T products which target CD19 will be allowed, including dual-targeting products\n* Patients must have at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab and obinutuzumab in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,000/mcL\n* Platelets ≥ 50,000/mcL\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x institutional ULN if the patient has Gilbert syndrome\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\\^2\n* Patients with human immunodeficiency virus (HIV) infection are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months\n* Patients with a history of hepatitis B virus (HBV) infection or positive total hepatitis B core antibody (HBcAb) are eligible if the hepatitis B surface antigen (HBsAg) is negative and HBV DNA viral load is undetectable by polymerase chain reaction (PCR) at the time of screening. Such patients must be managed with appropriate anti-viral therapy, if indicated, and must be willing to undergo HBV DNA testing on day 1 of each cycle and every 3 months for at least 12 months after the final cycle of study treatment\n* Patients with a history of hepatitis C virus (HCV) infection or positive HCV antibody are eligible if HCV ribonucleic acid (RNA) viral load is undetectable by PCR\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are asymptomatic from CNS involvement\n* Patients with new, progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that patients are asymptomatic and immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as patients with prostate cancer or breast cancer receiving hormonal therapy\n* The effects of glofitamab and obinutuzumab on the developing human fetus are unknown. For this reason and because glofitamab and obinutuzumab are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of glofitamab and 6 months after completion of obinutuzumab administration. Women of childbearing potential must use effective contraceptive precautions 2 months after completion of glofitamab treatment and 18 months after the last dose of obinutuzumab treatment\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab and obinutuzumab\n* Pregnant women are excluded from this study because glofitamab and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with glofitamab and obinutuzumab, breastfeeding should be discontinued if the mother is treated with glofitamab and obinutuzumab\n* Patients with active CRS or requiring intervention for CRS within 14 days prior to study enrollment\n* Patients with active neurotoxicity or requiring intervention for neurotoxicity within 14 days prior to study enrollment\n* Patients requiring antimicrobial treatment or hospitalization for active infection within 14 days prior to study enrollment for known active bacterial, viral (including severe acute respiratory syndrome coronavirus 2 \\[SARS-CoV-2\\]), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Infection must be completely resolved prior to initiation of study treatment\n* Patients receiving systemic immunosuppressive medications within 14 days prior to study enrollment, including, but not limited to: prednisone ≥ 20 mg per day, azathioprine, methotrexate, anti-tumor necrosis factor agents, anti-interleukin-6/6R agents, or anti-interleukin 1 agents, are not eligible. The use of inhaled corticosteroids is permitted\n* Patients with known or suspected chronic active Epstein Barr virus (EBV) or cytomegalovirus (CMV) infection\n* Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Patients with prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Patients with known history of progressive multifocal leukoencephalopathy\n* Patients with current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed\n* Patients with the significant cardiovascular disease, including New York Heart Association class III or IV or otherwise symptomatic heart failure (stage C or D), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina\n* Patients who have undergone major surgery for non-diagnostic purposes within 4 weeks before first study treatment\n* Patients who have received a live attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Patients with a positive SARS-CoV-2 test 7 days prior to enrollment\n* Patients with current or past history of Waldenström macroglobulinemia\n* Patients with an active autoimmune disease that could be exacerbated by immunotherapy, excluding those with a remote history or well-controlled autoimmune disease","locations":[{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital/Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Saint Joseph's Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky/Markey Cancer Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University/Sidney Kimmel Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Case Western Reserve University","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University/Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Objective response rate"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":["car-t"],"locationSlugs":["duarte-california","atlanta-georgia","lexington-kentucky","baltimore-maryland","cleveland-ohio","columbus-ohio","pittsburgh-pennsylvania","nashville-tennessee","charlottesville-virginia"],"enrichment":{"headline":"Phase 2: testing Glofitamab for Recurrent Mantle Cell Lymphoma","inPlainEnglish":"This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy. CAR T-cell therapy is a form of immunotherapy where the immune system cell, T-cell, is changed to attack cancer cells.","whoItsFor":["Ages 18 Years to any","Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen)","Patients must have at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan","Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab and obinutuzumab in patients \\< 18 years of age, children are excluded from this study","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)","Absolute neutrophil count ≥ 1,000/mcL","Platelets ≥ 50,000/mcL","Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x institutional ULN if the patient has Gilbert syndrome"],"whoShouldSkip":["Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia","Patients who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab and obinutuzumab","Patients with active CRS or requiring intervention for CRS within 14 days prior to study enrollment","Patients with active neurotoxicity or requiring intervention for neurotoxicity within 14 days prior to study enrollment","Patients with known or suspected chronic active Epstein Barr virus (EBV) or cytomegalovirus (CMV) infection","Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Glofitamab. The registry lists allocation as na. This phase II trial tests the safety and side effects of glofitamab and obinutuzumab and how well they work in treating patients with mantle cell lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory) after receiving CD19-directed chimeric antigen receptor (CAR) T-cell therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at 11 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.411Z"},{"nctId":"NCT07003425","title":"A Long-term Safety and Efficacy Study Evaluating APG777 in Atopic Dermatitis","officialTitle":"A Long-term Extension Study to Evaluate the Safety and Efficacy of APG777 in Patients With Atopic Dermatitis Previously Treated With APG777","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Apogee Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).\n\nThe LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.\n\nThis study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.","conditions":["Atopic Dermatitis"],"keywords":["Atopic Dermatitis","APG777","Safety","Efficacy"],"interventions":[{"type":"DRUG","name":"APG777"},{"type":"DRUG","name":"APG777"},{"type":"DRUG","name":"APG777"}],"enrollment":350,"startDate":"2025-05-14","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol\n* Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777\n* Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study\n\nExclusion Criteria:\n\n* Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient\n* Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study\n* Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study\n* Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments\n\nNote: Additional protocol defined Inclusion/Exclusion criteria may apply","locations":[{"facility":"Investigational Site","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational 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The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period.","whoItsFor":["Ages 18 Years to any","Participants who have completed the Treatment Period in a prior APG777 study and were, in the Investigator's opinion, compliant with the study protocol","Participants who, in the Investigator's opinion, would benefit from long-term treatment with APG777","Use the same non-prescription non-medicated emollient/moisturizer of their choice from the last day of the Parent Study and throughout the LTE study"],"whoShouldSkip":["Participants who have developed an AE while participating in the Parent Study, which, in the opinion of the Investigator or of the Medical Monitor, could indicate that continued treatment with APG777 may present an unreasonable risk for the patient","Participants who terminated early from the Parent Study or permanently discontinued the study drug during the Parent Study","Use of any of the prohibited medications from Screening Visit (Visit 1) of the LTE study","Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or interfere with study assessments","Note: Additional protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are APG777, APG777, or APG777. The registry lists allocation as randomized. This is a multicenter, neither you nor the study doctors know who gets the real treatment, Long-Term Extension (LTE) study to measure the long-term safety and how well it works of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 350 people at 74 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.827Z"},{"nctId":"NCT07005102","title":"A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","officialTitle":"A Phase 2/3 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity \"when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. Osi is a drug approved for the treatment of NSCLC. This study will be divided into two stages, in the first stage participants will receive increasing doses of telisotuzumab adizutecan with Osi. Participants will then be randomized into 4 groups called treatment arms where 3 groups will receive 1 of 3 doses of telisotuzumab adizutecan from from the dose escalation phase with Osi, or standard of care (Osi plus chemotherapy). In the second stage participants will receive the optimal dose of telisotuzumab adizutecan, from the previous stage, with Osi, or SOC. Approximately 854 adult participants with 1L estimated glomerular filtration rate (EGFR) mut (mutated) not sufficient quantity (NSq) NSCLC will be enrolled in the study in 200 sites worldwide.\n\nIn Stage 1, during dose escalation participants will receive increasing intravenous (IV) doses of telisotuzumab adizutecan with oral Osi tablets. participants will receive 1 of 3 doses of telisotuzumab adizutecan with Osi, or standard of care (Osi plus chemotherapy). In stage 2 participants will receive the optimal dose of IV telisotuzumab adizutecanin with oral Osi tablet, or SOC. The study will run for a duration of approximately 76 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.","conditions":["Non-Squamous Non-Small Cell Lung Cancer","c-MET"],"keywords":["Non-Squamous Non-Small Cell Lung Cancer","Telisotuzumab Adizutecan","Osimertinib","Cisplatin","Carboplatin","Pemetrexed","ABBV-400","Stand of Care","Cancer","Chemotherapy","Platinum Chemotherapy"],"interventions":[{"type":"DRUG","name":"Standard of Care"},{"type":"DRUG","name":"Telisotuzumab Adizutecan"},{"type":"DRUG","name":"Osimertinib (Osi)"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"}],"enrollment":854,"startDate":"2025-08-03","completionDate":"2036-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1.\n* Must consent to provide recently obtained formalin-fixed, paraffin-embedded (FFPE) tumor tissue (ideally collected during or after locally advanced or metastatic diagnosis) or archived tissue during screening for c-Met immunohistochemistry (IHC) testing and study stratification. c-Met IHC results are required prior to randomization.\n* Must have at least one non-irradiated measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. If only one measurable lesion exists, it is acceptable to be used (as a target lesion) as long as it has not been previously irradiated and as long as it has not been biopsied within 14 days of the baseline tumor assessment scans.\n* Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Grade 1 or baseline level (except for alopecia \\[any grade\\] or Grade \\<= 2 peripheral neuropathy).\n* Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months.\n* No prior estimated glomerular filtration rate (EGFR) tyrosine kinase inhibitor (TKI) in the locally advanced and/or metastatic setting (except for when it is allowed on study prior to C1D1). Participants treated with prior EGFR TKI in the adjuvant setting are allowed to enroll provided that \\>= 126 months (since last dose of e.g., adjuvant osimertinib) have passed before Cycle 1, Day 1.\n* Diagnosis of histologically or cytologically confirmed metastatic/locally advanced non-squamous NSCLC with documented classical EGFR mutation (Exon 19 Del or Exon 21 L858R) either alone or in combination with other EGFR mutations as detected by an Food and Drug Administration (FDA)-approved or other validated test in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory (sites in the US) or an accredited Laboratory (sites outside of the US) in accordance with site standard of care. A copy of the test report documenting the EGFR mutation must be available in the participant records.\n\nExclusion Criteria:\n\n* History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan.\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.\n* History of any malignancy other than disease under study except for\n\n  1. Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator.\n  2. Successfully treated nonmelanoma skin cancer.\n  3. Localized carcinoma in situ of the cervix.\n  4. 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Campus Virga Jesse /ID# 275585","city":"Hasselt","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Leuven /ID# 275586","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ-Delta. /ID# 275753","city":"Roeselare","state":"West-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Liege /ID# 277971","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital - General Campus /ID# 275611","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre /ID# 274845","city":"Toronto","state":"Ontario","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cancer Hospital - Chinese Academy of Medical Sciences /ID# 275631","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Province Cancer Hospital /ID# 274913","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital Of Guangzhou Medical University /ID# 274914","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Tongji Medical College /ID# 278711","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First affiliated hospital of Nanchang University /ID# 275257","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Chest Hospital /ID# 275273","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University /ID# 274946","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center. /ID# 274540","city":"Petah Tikva","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center /ID# 274541","city":"Ramat Gan","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus- Haifa /ID# 274542","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 274948","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria San Luigi Gonzaga /ID# 275215","city":"Orbassano","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera di Perugia - Ospedale S. Maria della Misericordia /ID# 277808","city":"Perugia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Campus Bio-Medico /ID# 280103","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama Municipal Citizen's Hospital /ID# 275682","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niigata University Medical and Dental Hospital /ID# 275685","city":"Niigata","state":"Niigata","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Medical And Pharmaceutical University Hospital /ID# 275684","city":"Takatsuki","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center /ID# 278082","city":"Sunto-gun","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital /ID# 276424","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital /ID# 275678","city":"Chuo-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Braga, EPE /ID# 275394","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Santo Antonio /ID# 275387","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Cuf Porto /ID# 275395","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore /ID# 275986","city":"Singapore","state":"Central Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"National University Hospital /ID# 275988","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inje University Haeundae Paik Hospital /ID# 275388","city":"Busan","state":"Busan Gwang Yeogsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chungbuk National University Hospital /ID# 275768","city":"Cheongju-si","state":"North Chungcheong","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Health System Severance Hospital /ID# 275384","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center /ID# 275600","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center /ID# 278083","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic de Barcelona /ID# 275476","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Maranon /ID# 275475","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre /ID# 277698","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Valenciano de Oncologia /ID# 275471","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 275293","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Cancer Center (Ntucc) /ID# 275291","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital /ID# 275292","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Stage 1: Objective Response (OR) Based on Blinded Independent Central Review (BICR) Assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1","Stage 2: Progression-free survival (PFS) based on BICR assessment per RECIST version 1.1.","Number of Participants with Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["chandler-arizona","duarte-california","irvine-california","los-angeles-california","newport-beach-california","santa-monica-california","upland-california","aurora-colorado","orange-city-florida","honolulu-hawaii","west-des-moines-iowa","lincoln-nebraska","reno-nevada","austin-texas","houston-texas","palestine-texas","fairfax-virginia","seattle-washington","liverpool-australia","woodville-south-australia","heidelberg-australia","murdoch-australia","hasselt-belgium","leuven-belgium","roeselare-belgium","li-ge-belgium","ottawa-canada","toronto-canada","beijing-china","fuzhou-china","guangzhou-china","wuhan-china","nanchang-china","shanghai-china","chengdu-china","petah-tikva-israel","ramat-gan-israel","haifa-israel","rome-italy","orbassano-italy","perugia-italy","roma-italy","yokohama-japan","niigata-japan","takatsuki-japan","sunto-gun-japan","bunkyo-ku-japan","chuo-ku-japan","braga-portugal","porto-portugal","singapore-singapore","busan-south-korea","cheongju-si-south-korea","seoul-south-korea","barcelona-spain","madrid-spain","valencia-spain","kaohsiung-city-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Standard of Care for Non-Squamous Non-Small Cell Lung Cancer","inPlainEnglish":"Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. this study wants to assess side effects and change in disease activity \"when telisotuzumab adizutecan is given in combination with a fixed dose of osimertinib (Osi)or standard of care (Osi plus platinum/pemetrexed chemotherapy).","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 during the screening period and prior to dosing of study treatment on Cycle 1 Day 1","Any toxicities from prior systemic anti-cancer therapy must have resolved to common terminology criteria for side effects (CTCAE) Grade 1 or baseline level (except for alopecia \\[any grade\\] or Grade \\<= 2 peripheral neuropathy)","Should not have any major, life-threatening conditions and life expectancy as determined by the investigator should be at least 3 months"],"whoShouldSkip":["History of interstitial lung disease (ILD), pneumonitis that required treatment with systemic steroids, or any evidence of active ILD/pneumonitis on screening chest computed tomography (CT) scan","History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis","Participants has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation","History of any malignancy other than disease under study except for","Malignancy treated with curative intent and with no known active disease present for 2 years before the first dose of study treatment and felt to be at low risk for recurrence by investigator","Successfully treated nonmelanoma skin cancer","Localized carcinoma in situ of the cervix"],"whatHappens":"If you join, the listed intervention(s) are Standard of Care, Telisotuzumab Adizutecan, or Osimertinib (Osi). The registry lists allocation as randomized. Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 854 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.683Z"},{"nctId":"NCT07006831","title":"A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population","officialTitle":"A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Devyser Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to evaluate the status of the transplanted organ.","conditions":["Kidney Disease","Kidney Transplant","Transplant Recipient","Renal Function","Cell-free DNA","NGS"],"keywords":[],"interventions":[],"enrollment":400,"startDate":"2025-11-14","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Is 18 years of age or older at enrollment\n3. Had a kidney transplant prior to enrollment\n4. Is having an indication (for cause) biopsy as determined by clinician\n5. retrospective leftover samples are available from the kidney donor(s).\n\nExclusion Criteria:\n\n1. Is pregnant\n2. Had a blood transfusion within the past 4 weeks\n3. Had a transplant from an identical (monozygotic) twin\n4. Had transplants of multiple organs from the same donor (eg, kidney and liver transplant).\n5. Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)\n6. Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)","locations":[{"facility":"Scripps Health","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham & Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Methodist Hospital","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"COMPLETED","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Detection of donor-derived cell-free DNA (dd-cfDNA) from whole blood"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["san-diego-california","san-francisco-california","atlanta-georgia","baltimore-maryland","boston-massachusetts","san-antonio-texas","salt-lake-city-utah"],"enrichment":{"headline":"A Multicenter, Prospective Blood Collection Study in a Kidney Transplant Population","inPlainEnglish":"The purpose of this research is to collect blood samples and data from kidney transplant patients. The samples and data will be used for research and development of non-invasive test to detect donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients to measure the status of the transplanted organ.","whoItsFor":["Ages 18 Years to any","Is 18 years of age or older at enrollment","Had a kidney transplant prior to enrollment","Is having an indication (for cause) biopsy as determined by clinician","retrospective leftover samples are available from the kidney donor(s)"],"whoShouldSkip":["Had a blood transfusion within the past 4 weeks","Had a transplant from an identical (monozygotic) twin","Had transplants of multiple organs from the same donor (eg, kidney and liver transplant)","Had transplants of more than 2 organs from different donors (eg, recipient of a third kidney transplant)","Had a transplant of hematopoietic stem cells (eg, bone marrow) or tissue (eg, heart valve)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.568Z"},{"nctId":"NCT07006935","title":"REACH Study (Recovery Environments: Assessing Cognitive & Brain Health in Community Mental Health)","officialTitle":"Pilot Study of the Cognitive and Neurobiological Effects of the Clubhouse Model of Psychosocial Rehabilitation for Schizophrenia and Related Conditions","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Case Western Reserve University","sponsorClass":"OTHER","summary":"The purpose of this study is to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services. If participants decide to join, they will be asked to complete a total of six study visits with the research team over the course of your participation. Three of these study visits are at the beginning (baseline) and the remaining three are six months later. Two of the three visits will includes interviews, questionnaires, and thinking and memory tasks (cognitive testing) and one session will be an MRI brain scan, which is a safe and non-invasive imaging procedure. The total time required for each visit will be approximately 90 minutes to two hours. Participants may take breaks as needed.","conditions":["Schizophrenia","Schizo Affective Disorder","Schizophreniform Disorders"],"keywords":["Clubhouse Model of Psychosocial Rehabilitation","Community mental health interventions","Cognition","Brain functioning"],"interventions":[{"type":"BEHAVIORAL","name":"Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness"},{"type":"BEHAVIORAL","name":"Usual Community-Based Mental Health Care"}],"enrollment":30,"startDate":"2026-09-01","completionDate":"2028-01-30","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* (1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review\n* (2) between the ages of 18-50\n* (3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month\n* (4) able to read and speak fluent English at a sixth grade level or higher for purposes of informed consent and cognitive testing\n* For Clubhouse members, they must be a first-time, newly enrolled member\n\nExclusion Criteria:\n\n* (1) had previous membership at a Clubhouse (Magnolia or elsewhere)\n* (2) have a current severe substance use disorder\n* (3) have persistent suicidal or homicidal behavior\n* (4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)\n* (5) had recent psychiatric instability requiring hospitalization in the past month;\n* (6) history of a traumatic brain injury (TBI; based on record review)\n* (7) contraindicators for MRI (e.g., pacemaker, claustrophobia)\n* Participants in the usual care will be excluded if they are a current Clubhouse member or join a Clubhouse during participation in this research","locations":[{"facility":"Case Western Reserve University","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica A Wojtalik, PhD","phone":"216-368-1329","email":"reach-study@case.edu"}],"primaryOutcomes":["Change in overall cognitive performance as measured by MATRICS Consensus Cognitive Battery (MCCB)","Change in functional outcome as measured by Specific Levels of Functioning Scale (SLOF)","Change in quality of life as measured by World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF)","Change in disability as measured by the 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0","Change in task-based brain activation during functional MRI (fMRI) as measured by the AX-Continuous Performance Task (AX-CPT)","Change in task-based brain activation during functional MRI (fMRI) as measured by the Emotional Faces N-Based Task (EFNBACK)"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness for Schizophrenia","inPlainEnglish":"This study wants to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions. The investigators are especially interested in learning whether the Clubhouse Model-a structured, supportive community for individuals with mental illness-has unique benefits compared to standard outpatient mental health services.","whoItsFor":["Ages 18 Years to 50 Years","(1) have a DSM-V diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform confirmed by diagnostic assessment and medical record review","(2) between the ages of 18-50","(3) stabilized on psychotropic medication as indicated by no changes to the primary psychiatric medication in the last month","For Clubhouse members, they must be a first-time, newly enrolled member"],"whoShouldSkip":["(1) had previous membership at a Clubhouse (Magnolia or elsewhere)","(2) have a current severe substance use disorder","(3) have persistent suicidal or homicidal behavior","(4) a co-occurring diagnosis of an intellectual or learning disability or neurodevelopment condition (e.g., Autism; based on chart review)","(5) had recent psychiatric instability requiring hospitalization in the past month;","(6) history of a traumatic brain injury (TBI; based on record review)","(7) contraindicators for MRI (e.g., pacemaker, claustrophobia)"],"whatHappens":"If you join, the listed intervention(s) are Clubhouse Model of Psychosocial Rehabilitation for Serious Mental Illness, or Usual Community-Based Mental Health Care. The registry lists allocation as randomized. This study wants to understand how different types of community-based mental health care affect thinking abilities, daily functioning, and brain activity in adults with schizophrenia and related conditions.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Cleveland. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.040Z"},{"nctId":"NCT07007065","title":"Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)","officialTitle":"A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).\n\nSurabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.\n\nParticipants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","conditions":["Neovascular Age-related Macular Degeneration"],"keywords":["Neovascular age-related macular degeneration","Surabgene Lomparvovec","ABBV-RGX-314"],"interventions":[{"type":"DRUG","name":"Surabgene Lomparvovec (ABBV-RGX-314)"},{"type":"DRUG","name":"Ranibizumab Control"}],"enrollment":561,"startDate":"2025-11-05","completionDate":"2033-03","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \\[Week -6\\]) in the study eye.\n* Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye\n\n  --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\\^2)\n* Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)\n\nExclusion Criteria:\n\n* CNV or macular edema in the study eye that is secondary to any causes other than AMD\n* Study eye with nAMD diagnosed \\> 4 years from Screening Visit 1\n* Any retinal pigment epithelial detachment \\> 400 μm or any pigment epithelial detachment \\> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.\n* Any subretinal hemorrhage in the study eye \\> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center\n* Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.","locations":[{"facility":"Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265","city":"Mesa","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Vision Partners /ID# 264615","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Diagnostic Center /ID# 263054","city":"Campbell","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Retina Partners /ID# 263265","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Southern California /ID# 263056","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shiley Eye Institute At Uc San Diego Health /ID# 276682","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern California Retina Vitreous Associates - 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Events"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":[],"locationSlugs":["mesa-arizona","sun-city-arizona","campbell-california","encino-california","huntington-beach-california","la-jolla-california","mountain-view-california","newport-beach-california","poway-california","redlands-california","riverside-california","sacramento-california","san-francisco-california","santa-ana-california","colorado-springs-colorado","lakewood-colorado","longmont-colorado","deerfield-beach-florida","delray-beach-florida","fort-myers-florida","orlando-florida","winter-haven-florida","augusta-georgia","oak-lawn-illinois","springfield-illinois","carmel-indiana","west-des-moines-iowa","lenexa-kansas","portland-maine","baltimore-maryland","towson-maryland","royal-oak-michigan","edina-minnesota","rochester-minnesota","st-louis-missouri","reno-nevada","little-silver-new-jersey","cleveland-ohio","columbus-ohio","dublin-ohio","erie-pennsylvania","philadelphia-pennsylvania","bluffton-south-carolina","charleston-south-carolina","ladson-south-carolina","mt-pleasant-south-carolina","rapid-city-south-dakota","abilene-texas","austin-texas","burleson-texas","houston-texas","round-rock-texas","san-antonio-texas","murray-utah","mistelbach-austria","graz-austria","innsbruck-austria","linz-austria","salzburg-austria","ghent-belgium","leuven-belgium","burgas-bulgaria","plovdiv-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","ottawa-canada","grad-zagreb-croatia","zagreb-croatia","prague-czechia","nice-france","lyon-france","bordeaux-france","nantes-france","cully-france","cr-teil-france","marseille-france","paris-france","freiburg-im-breisgau-germany","t-bingen-germany","ulm-germany","munich-germany","g-ttingen-germany","hanover-germany","bonn-germany","m-nster-germany","ludwigshafen-am-rhein-germany","l-beck-germany","berlin-germany","hamburg-germany","athens-greece","cha-d-ri-greece","heraklion-greece","larissa-greece","p-cs-hungary","debrecen-hungary","budapest-hungary","holon-israel","petah-tikva-israel","rehovot-israel","tsrifin-israel","ramat-gan-israel","tel-aviv-israel","haifa-israel","jerusalem-israel","cona-italy","florence-italy","rome-italy","ancona-italy","reggio-emilia-italy","coimbra-portugal","lisbon-portugal","porto-portugal","arecibo-puerto-rico","c-rdoba-spain","donostia-san-sebastian-spain","majadahonda-spain","asturias-spain","seville-spain","barcelona-spain","madrid-spain","valencia-spain","zaragoza-spain","gloucester-united-kingdom","london-united-kingdom","bristol-united-kingdom","liverpool-united-kingdom","newcastle-upon-tyne-united-kingdom","sunderland-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Surabgene Lomparvovec (ABBV-RGX-314) for Neovascular Age-related Macular Degeneration","inPlainEnglish":"Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. this study wants to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).","whoItsFor":["Ages 50 Years to any","Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \\[Week -6\\]) in the study eye","Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye","CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\\^2)","Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)"],"whoShouldSkip":["CNV or macular edema in the study eye that is secondary to any causes other than AMD","Study eye with nAMD diagnosed \\> 4 years from Screening Visit 1","Any retinal pigment epithelial detachment \\> 400 μm or any pigment epithelial detachment \\> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center","Any subretinal hemorrhage in the study eye \\> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center","Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center"],"whatHappens":"If you join, the listed intervention(s) are Surabgene Lomparvovec (ABBV-RGX-314), or Ranibizumab Control. The registry lists allocation as randomized. Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 561 people at 138 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.145Z"},{"nctId":"NCT07007559","title":"ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer","officialTitle":"Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"ALX Oncology Inc.","sponsorClass":"INDUSTRY","summary":"The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting.\n\nASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows:\n\n* Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.\n* Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.","conditions":["Breast Cancer, Metastatic"],"keywords":["metastatic","Her2+","metastatic HER2-positive breast cancer","breast cancer","HER2-positive","Evorpacept","CD47","ERBB2","Enhertu","trastuzumab deruxtecan","ASPEN-09","Herceptin","solid tumors","trastuzumab","ALX148","mBC","ASPEN-Breast"],"interventions":[{"type":"DRUG","name":"Evorpacept (ALX148)"},{"type":"DRUG","name":"Trastuzumab"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Eribulin"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Vinorelbine"}],"enrollment":120,"startDate":"2025-12-10","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1.\n* Received no more than 4 prior lines of HER2-directed therapy including at least one prior line of T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer. Prior neoadjuvant therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible.\n* Progressed on or following the most recent line of therapy.\n* Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine).\n* Measurable disease as defined by RECIST v1.1.\n* LVEF ≥50%.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.\n* Life expectancy of at least 3 months.\n* Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n* Adequate liver function:\n\n  * Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome);\n  * Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).\n* Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible and which do not constitute a safety risk by Investigator judgment.\n\nExclusion Criteria:\n\n* Untreated CNS metastases.\n* Prior exposure to any anti-CD47 or anti-SIRPα agent.\n* Any condition that would be contraindicated to receiving trastuzumab\n* Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen\n* Following anti-cancer therapy with insufficient washout before start of treatment:\n\n  1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment.\n  2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment).\n* History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.\n* Had an allogeneic tissue/solid organ transplant.\n* Any active, unstable cardiovascular disease.\n* Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).\n* Has an active autoimmune disease that has required systemic treatment in past 2 years.\n* Other primary malignancy within 2 years.","locations":[{"facility":"Mayo Clinic Building-Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Arizona Cancer Center - North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health - Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Joseph Hospital - Cancer Centers of Colorado","city":"Denver","state":"Colorado","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Lutheran Hospital - Cancer Centers of Colorado","city":"Golden","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Mary's Regional Hospital - Cancer Centers of Colorado","city":"Grand Junction","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The George Washington Medical facility Associates","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sylvester Comprehensive Cancer Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Chicago","city":"Zion","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Rogel Cancer Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Cancer Center","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HealthPartners Frauenshuh Cancer Center","city":"Saint Louis Park","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine- Siteman Cancer Center","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Vincent Regional Hospital - Cancer Centers of Montana","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Hematology West, Pc Dba Nebraska Cancer Specialists","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabrail Cancer Center","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas M.D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network, Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Besancon","city":"Besançon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Bergonie","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital de l'Institut Curie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Europeen Georges Pompidou (HEGP)","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Poitiers","city":"Poitiers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugene Marquis","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria delle Marche","city":"Torrette","state":"AN","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliera Metropolitana","city":"Genova","state":"GE","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Papa Giovanni XXIII","city":"Bergamo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS- Istituto Europeo di Oncologia","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo Dei Tintori","city":"Monza","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia","city":"Novara","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Curie Oncology - Farrer","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inha University Hospital","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria","city":"Málaga","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario De Basurto","city":"Bilbao","state":"Basque Country","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Arnau de Villanova","city":"Lleida","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de la Santa Creu i Sant Pau","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Beata Maria Ana","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust - St Bartholomew's Hospital","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre, Velindre University NHS Trust","city":"Cardiff","state":"Wales","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nottingham University Hospital NHS Trust","city":"Nottingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cheng Quah, MD","phone":"650-466-7125","email":"info@alxoncology.com"}],"primaryOutcomes":["Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment"],"hasResults":false,"conditionSlugs":["breast-cancer","colorectal-cancer","head-and-neck-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["phoenix-arizona","tucson-arizona","duarte-california","la-jolla-california","orange-california","denver-colorado","golden-colorado","grand-junction-colorado","washington-d-c-district-of-columbia","jacksonville-florida","miami-florida","tampa-florida","zion-illinois","ann-arbor-michigan","rochester-minnesota","saint-louis-park-minnesota","st-louis-missouri","billings-montana","omaha-nebraska","new-york-new-york","durham-north-carolina","canton-ohio","portland-oregon","dallas-texas","houston-texas","fairfax-virginia","seattle-washington","toronto-canada","besan-on-france","bordeaux-france","paris-france","poitiers-france","rennes-france","villejuif-france","torrette-italy","genova-italy","bergamo-italy","bologna-italy","milan-italy","monza-italy","novara-italy","singapore-singapore","incheon-south-korea","seoul-south-korea","m-laga-spain","seville-spain","bilbao-spain","barcelona-spain","lleida-spain","madrid-spain","london-united-kingdom","cardiff-united-kingdom","nottingham-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Evorpacept (ALX148) for Breast Cancer, Metastatic","inPlainEnglish":"The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs.","whoItsFor":["Ages 18 Years to any","Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1","Progressed on or following the most recent line of therapy","Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)","Measurable disease as defined by RECIST v1.1","Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1","Life expectancy of at least 3 months","Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation"],"whoShouldSkip":["Untreated CNS metastases","Prior exposure to any anti-CD47 or anti-SIRPα agent","Any condition that would be contraindicated to receiving trastuzumab","Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen","Following anti-cancer therapy with insufficient washout before start of treatment:","chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment","Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment)"],"whatHappens":"If you join, the listed intervention(s) are Evorpacept (ALX148), Trastuzumab, or Paclitaxel. The registry lists allocation as na. The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the how well it works, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 61 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.974Z"},{"nctId":"NCT07009899","title":"BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)","officialTitle":"BCMA Bispecific Antibody Therapy for Post-BCMA CAR T-Cell Therapy Relapse (RECLAIM)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Medical College of Wisconsin","sponsorClass":"OTHER","summary":"This is a single-center, single-arm, phase 2 study designed to evaluate the efficacy and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.","conditions":["Multiple Myeloma"],"keywords":["Bispecific Antibody","BCMA","BCMA CAR T-Cell Therapy","linvoseltamab","Multiple Myeloma"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"}],"enrollment":34,"startDate":"2026-08-31","completionDate":"2028-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3.\n3. Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment.\n\n   a. Note: Up to 15% of patients who are \\< 6 months out from their standard of care of investigational BCMA CAR T-cell therapy will be included in the study as long as i) their bone marrow biopsy sample tests positive for BCMA expression by immunohistochemistry and ii) they have stem cells available for a stem cell boost therapy prior to linvoseltamab administration.\n4. Must have measurable disease for response assessment as per the IMWG response assessment criteria.\n\n   a. Note: if a patient does not have measurable serum M or free light chain, evidence of measurable disease by imaging is acceptable (e.g., extramedullary disease, new lesions).\n5. Adequate hepatic function as defined below:\n\n   1. 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Known to have hepatitis A, B, or C active infection.\n7. Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n8. Concurrent hematologic or non-hematologic malignancy requiring treatment (other than multiple myeloma and secondary amyloidosis).\n9. Cardiac syncope, uncompensated New York Heart Association (NYHA) Class 3 or 4 congestive heart failure, myocardial infarction within the previous six months, unstable angina pectoris, clinically significant repetitive ventricular arrhythmias despite antiarrhythmic treatment, cardiac ejection fraction \\< 40% by echocardiogram or multi-gated acquisition (MUGA) scan, severe orthostatic hypotension, or clinically important autonomic disease.\n10. Major surgery within 14 days prior to start of study treatment (Note: vertebroplasty and kyphoplasty are not considered major surgery).\n11. Infection requiring systemic antibiotic therapy or other serious infection within 14 days prior to start of study treatment.\n12. Active treatment in other clinical trials, including those where a subject received an investigational drug within 30 days or five half-lives of the investigational drug prior to start of study treatment, whichever is longer.\n13. Any clinically significant, uncontrolled medical conditions that, in the investigator's opinion, would expose the subject to excessive risk or may interfere with compliance or interpretation of the study results.\n14. Pregnant or breastfeeding women.\n15. Women of childbearing potential (WOCBP) or sexually active men who are unwilling to practice highly effective contraception prior to the start of study therapy, during the study, and for at least 6 months after the last dose of the study drug.\n\n    1. WOCBP are defined as women who are fertile following menarche until becoming postmenopausal (defined as no menses for 12 months without an alternative medical cause), unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy.\n    2. Male study participants with WOCBP partners are required to use condoms unless they are vasectomized or practice sexual abstinence. Male study participants should not donate sperm during the study, and for at least 6 months after the last dose\n16. Highly effective contraceptive measures include stable use of combined (estrogen and progestogen-containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated two or more menstrual cycles prior to screening; intrauterine device; intrauterine hormone-releasing system; bilateral tubal ligation; vasectomized partner (provided that the vasectomized partner is the sole sexual partner of the WOCBP study participant); and or sexual abstinence.","locations":[{"facility":"Froedtert & the Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical College of Wisconsin Cancer Center Clinical Trials Office","phone":"866-680-0505","email":"cccto@mcw.edu"}],"primaryOutcomes":["Overall Response Rate"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["milwaukee-wisconsin"],"enrichment":{"headline":"Phase 2: testing Linvoseltamab for Multiple Myeloma","inPlainEnglish":"This is a single-center, single-arm, phase 2 study designed to measure the how well it works and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status criteria of 0-3","Received any standard of care or investigational BCMA CAR T-cell therapy as their last line of therapy ≥ 6 months prior to enrollment","Must have measurable disease for response assessment as per the IMWG response assessment criteria","a. 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The registry lists allocation as na. This is a single-center, single-arm, phase 2 study designed to measure the how well it works and safety of linvoseltamab in multiple myeloma (MM) patients who relapsed following BCMA CAR T-cell therapy, whether standard of care or investigational.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 34 people at Milwaukee. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.502Z"},{"nctId":"NCT07011719","title":"Study of Casdatifan and Cabozantinib Versus Placebo and Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma","officialTitle":"A Randomized, Double-Blind, Active-Control, Multicenter Phase 3 Trial of Casdatifan and Cabozantinib Versus Placebo and 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.327Z"},{"nctId":"NCT07012031","title":"Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation","officialTitle":"A Phase I/II Study Evaluating the Safety, Tolerability, and Efficacy of Sotorasib Plus Trastuzumab Deruxtecan in Patients With Advanced Non-Small Cell Lung Cancer With a KRASG12C Mutation","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them. It is a type of targeted therapy. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving sotorasib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or effective in treating patients with locally advanced or metastatic non-small cell lung cancer with a KRAS G12C mutation.","conditions":["Locally Advanced Lung Non-Small Cell Carcinoma","Metastatic Lung Non-Small Cell Carcinoma","Stage III Lung Cancer AJCC v8","Stage IV Lung Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Sotorasib"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":37,"startDate":"2026-06-17","completionDate":"2027-06-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologically or cytologically documented locally advanced or metastatic KRAS\\^G12C-mutant NSCLC that has previously been treated with a KRAS\\^G12C inhibitor AND an immune checkpoint inhibitor (ICI) AND chemotherapy, either given concurrently or sequentially, UNLESS they have any contra-indications to any drug class described above\n* Patients must have KRAS\\^G12C mutation identified by tumor tissue or plasma circulating tumor deoxyribonucleic acid (ctDNA) profiling using a Clinical Laboratory Improvement Act (CLIA) certified College of American Pathologists (CAP) accredited platform; local molecular testing will be allowed. Testing must have been done within the last 5 years before enrollment in this study\n* Data must be available for which prior KRAS\\^G12C inhibitor treatment the patient has received and the dates that they received it (type of KRAS\\^G12C inhibitor used and start and end dates must be collected prior to enrollment)\n* Data must be available on the date patients received the last dose of KRAS\\^G12C inhibitor and the date of disease progression on their last treatment prior to screening for this trial. Data must be available on the last treatment they received and if it was not or did not include a KRAS\\^G12C inhibitor. The time between last KRAS\\^G12C inhibitor and treatment on this trial will be collected prior to enrollment\n* Data must be available on historical HER2 immunohistochemistry (IHC) status (date of test, type of antibody used for the IHC test, scoring system \\[i.e., breast versus (vs.) gastric\\], and results must be collected prior to enrollment). Patients must also have ERBB2 (HER2) mutations status identified by tumor tissue or plasma ctDNA profiling; local (i.e., commercial or institutional next generation sequencing \\[NGS\\]) molecular testing will be allowed. Patients who do not have this information available for collection will not be enrolled on this study\n* Patients must have measurable disease, as defined by RECIST v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI). Previously irradiated lesions cannot be counted as target lesions unless there has been demonstrated progression in the lesions since radiotherapy and no other lesions are available for selection as target lesions\n* Age ≥ 18 years at date of informed consent form signature\n\n  * Because no dosing or adverse event data are currently available on the use of sotorasib (AMG-510) in combination with trastuzumab deruxtecan (DS-8201a) in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Hemoglobin ≥ 9 g/dL (within 14 days of enrollment)\n* Leukocytes ≥ 3,000/mcL (within 14 days of enrollment)\n* Absolute neutrophil count ≥ 1,500/mcL (within 14 days of enrollment)\n\n  * No administration of granulocyte colony stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000/mcL (within 14 days of enrollment)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (within 14 days of enrollment), (\\< 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (within 14 days of enrollment) (\\< 5 x ULN in participants with liver metastases)\n* Serum albumin ≥ 2.5 g/dL (within 14 days of enrollment)\n* International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (within 14 days of enrollment)\n* Creatinine ≤ 1.5 x institutional ULN OR creatinine clearance (CrCL) ≥ 30 mL/min/ as determined by (using actual body weight) (within 14 days of enrollment)\n* Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible with 1 day washout for stereotactic radiosurgery (SRS) and 2 weeks washout for whole brain radiation (WBRT)\n* Patients with new or progressive brain metastases (active brain metastases) are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients must have a life expectancy of ≥ 12 weeks\n* Patients must have a corrected QT interval (QTc) ≤ 470 msec for women and ≤ 450 msec for men (based on average screening triplicates)\n* Patients must be willing to undergo a mandatory pre-treatment biopsy (28 days before treatment starts on cycle 1 day 1 \\[C1D1\\]) for patients enrolled into the expansion phase (phase II). The pre-treatment biopsy is optional for patients enrolled into the dose escalation phase (phase I)\n* Patients must have the ability to ingest and retain oral (PO) medications\n* The effects of the combination of sotorasib (AMG-510) and trastuzumab deruxtecan (DS-8201a) on the developing human fetus are unknown. For this reason and because HER-2-directed antibody conjugated to a topoisomerase 1 inhibitor agents are known to be teratogenic, women of child-bearing potential (WOCBP) must agree to use dual methods of contraception and must have a negative serum pregnancy testing at screening. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women treated or enrolled on this protocol must agree to use a highly effective method of contraception, if sexually active, or avoid intercourse during the study treatment and for 7 months following the last dose of study drug. Sotorasib (AMG-510) may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method on study and for an additional 7 days after the last dose of sotorasib (AMG-510). Men treated or enrolled on this protocol must also agree to use a highly effective barrier method of contraception, if sexually active, or avoid intercourse throughout the duration of the study and for 4 months following the last dose of study drug. To prevent exposure of the unborn child to sotorasib (AMG-510) through semen, male subjects will be required to practice true sexual abstinence (not have sex) or must wear a condom during vaginal sex\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU/mL and estradiol \\< 40 pg/mL \\[\\< 147 pmol/L\\] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, has current ILD, or where suspected ILD cannot be ruled out by imaging at screening. These patients will be excluded because trastuzumab deruxtecan (DS-8201a) is known to increase the risk of developing ILD and pneumonitis\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, prior complete pneumonectomy), and any autoimmune, connective tissue or inflammatory disorders (e.g., rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented or a suspicion of pulmonary involvement or pneumonectomy at the time of screening. These patients will be excluded because trastuzumab deruxtecan (DS-8201a) is known to increase the risk of developing ILD and pneumonitis\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) are known to increase the risk of developing pneumonitis\n* Patients who have had a major surgery and are not yet fully healed from surgical incisions\n* Patients who have had prior treatment with an antibody drug conjugate with a topoisomerase 1 inhibitor payload (i.e., sacituzumab govitecan, datopotomab deruxtecan, or trastuzumab deruxtecan) or with a topoisomerase inhibitor\n* Patients with a history of significant lung disease requiring systemic corticosteroids treatment (\\> 10 mg of prednisone daily) within the last six months of registration\n* Based on pre-clinical data, trastuzumab deruxtecan (DS-8201a) is associated with corneal disease. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study\n* Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia. Subjects with chronic grade 2 toxicities (i.e., defined as no worsening to \\> grade 2 for at least 3 months prior to first exposure to study intervention and managed with standard of care treatment) may be eligible per the discretion of the investigator after consultation with the sponsor medical monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy). Subjects should no longer be symptomatic nor require treatment with corticosteroids (prednisone \\> 10 mg or equivalent) or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Patients who are receiving any other investigational agents\n* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to sotorasib (AMG-510), such as adagrasib, or trastuzumab deruxtecan (DS-8201a)\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients who are taking strong CYP3A4 inducers should be switched to an alternative drug\n* Avoid coadministration with P-glycoprotein (P-gp) substrates for which minimal concentration changes may lead to serious toxicities. If coadministration cannot be avoided, dose adjustment of the substrate may be required. Please refer to the prescribing information for the substrate\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous or interfere with the evaluation of the clinical study results\n* Pregnant women are excluded from this study because trastuzumab deruxtecan (DS-8201a) is a HER2-directed antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with trastuzumab deruxtecan (DS-8201a) breastfeeding should be discontinued if the mother is treated with trastuzumab deruxtecan (DS-8201a). These potential risks may also apply to other agents used in this study\n* Patients with uncontrolled or significant cardiovascular disease (i.e., history of myocardial infarction within 6 months from screening, symptomatic congestive heart failure \\[CHF\\] \\[New York Heart Association class II to IV\\], troponin levels consistent with myocardial infarction 28 days prior to enrollment, history of unstable angina, or serious cardiac arrhythmia)\n* Patients with prior history of pneumonitis grade 2 or higher or ILD\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients unable to receive both iodinated contrast for CT scans and gadolinium contrast for MRI scans\n* Patients that have pleural effusion, ascites, or pericardial effusion that requires drainage within 2 weeks of study screening procedures, peritoneal shunt, or cell-free and concentrated ascites reinfusion therapy (CART)\n* Patients that have received a live vaccine within 30 days prior to the first dose of study drug will be excluded. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, bacillus Calmette- Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed","locations":[{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center-International Plaza","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center - McKinley Campus","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center at Wesley Chapel","city":"Wesley Chapel","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Case Western Reserve University","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Dose-limiting toxicities of combined trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) treatment (Phase I)","Overall response rate (ORR) (Phase II)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["trastuzumab-deruxtecan","sotorasib"],"locationSlugs":["sacramento-california","tampa-florida","wesley-chapel-florida","cleveland-ohio","columbus-ohio","pittsburgh-pennsylvania","charlottesville-virginia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Sotorasib for Locally Advanced Lung Non-Small Cell Carcinoma","inPlainEnglish":"This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Sotorasib blocks a protein made by the mutated KRAS gene (KRAS p.G12C), which may help keep tumor cells from growing and may kill them.","whoItsFor":["Ages 18 Years to any","Data must be available for which prior KRAS\\^G12C inhibitor treatment the patient has received and the dates that they received it (type of KRAS\\^G12C inhibitor used and start and end dates must be collected prior to enrollment)","Because no dosing or adverse event data are currently available on the use of sotorasib (AMG-510) in combination with trastuzumab deruxtecan (DS-8201a) in patients \\< 18 years of age, children are excluded from this study","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)","Hemoglobin ≥ 9 g/dL (within 14 days of enrollment)","Leukocytes ≥ 3,000/mcL (within 14 days of enrollment)","Absolute neutrophil count ≥ 1,500/mcL (within 14 days of enrollment)","No administration of granulocyte colony stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment"],"whoShouldSkip":["Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because trastuzumab deruxtecan (DS-8201a) and sotorasib (AMG-510) are known to increase the risk of developing pneumonitis","Patients who have had a major surgery and are not yet fully healed from surgical incisions","Patients who have had prior treatment with an antibody drug conjugate with a topoisomerase 1 inhibitor payload (i.e., sacituzumab govitecan, datopotomab deruxtecan, or trastuzumab deruxtecan) or with a topoisomerase inhibitor","Patients with a history of significant lung disease requiring systemic corticosteroids treatment (\\> 10 mg of prednisone daily) within the last six months of registration","Based on pre-clinical data, trastuzumab deruxtecan (DS-8201a) is associated with corneal disease. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study","Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms","Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals"],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as na. This phase I/II trial tests the safety, side effects and best dose of sotorasib with trastuzumab deruxtecan and how well the combination works in treating patients with KRAS G12C mutated non-small cell lung cancer that has spread to nearby tissues or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 37 people at 9 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.969Z"},{"nctId":"NCT07013201","title":"A 16-week Trial to Investigate the Efficacy and Safety of Delgocitinib Cream 20 mg/g in Adult Participants With Mild to Severe Palmoplantar Pustulosis","officialTitle":"A Proof-of-concept Phase 2a, Double-blind, 2-arm Trial to Investigate the Efficacy and Safety of Twice Daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle During a 16-week Treatment Period in Adult Subjects With Mild to Severe Palmoplantar Pustulosis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"LEO Pharma","sponsorClass":"INDUSTRY","summary":"The main objective of the study is to evaluate the efficacy of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each participants will be approximately 18 weeks, for an approximate total of 9 visits.","conditions":["Palmoplantar Pustulosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Delgocitinib cream"},{"type":"DRUG","name":"Vehicle cream"}],"enrollment":135,"startDate":"2025-09-11","completionDate":"2027-06-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed and dated informed consent has been obtained prior to any protocol-related procedures.\n* Age 18 years or above at the time of informed consent signing.\n* Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator.\n* Diagnosis of PPP in accordance with the consensus diagnostic criteria established by European Rare and Severe Psoriasis Expert Network: primary, persistent (\\>3 months duration), sterile, macroscopically visible pustules on the palms and/or soles, with or without plaque psoriasis elsewhere on the body.\n* Confirmed PPP by central evaluation of photographs taken at screening.\n* Mild to severe PPP current condition defined by:\n\n  * Disease duration of PPP of \\>6 months before randomisation.\n  * PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline.\n  * PPPASI ≥8 at screening and baseline.\n* Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline.\n* Participants with prior experiences of inadequate response with topical corticosteroid(s) (TCS) or for whom TCS are inadvisable, as judged by the investigators.\n* A woman of childbearing potential must use an acceptable form of birth control throughout the trial up until the last administration of investigational medicinal product (IMP).\n\nExclusion Criteria:\n\n* Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an exacerbation of PPP from beta blockers, calcium channel blockers, lithium, or biologic therapy including infliximab, adalimumab, or etanercept).\n* Presence of acrodermatitis continua of Hallopeau.\n* Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator.\n* Clinically significant infection on the palms or soles.\n* Concurrent plaque psoriasis covering \\>5% of body surface area.\n* Clinically significant infection within 4 weeks prior to baseline, which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial. Clinically significant infections are defined as:\n\n  * A systemic infection.\n  * A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication.\n* History of any known primary immunodeficiency disorder, including a positive human immunodeficiency virus test at screening, or the participant taking antiretroviral medications as determined by medical history and/or the participant's verbal report.\n* Major surgery within 8 weeks prior to screening or planned in-patient surgery or hospitalisation during the trial period.\n* Any documented active or suspected malignancy, or history of malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix appropriately treated before the baseline visit.\n* Any disorder that is not stable and could:\n\n  * Affect the safety of the participant throughout the trial.\n  * Impede the participant's ability to complete the trial. Examples include, but are not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, as well as major physical impairment.\n* Any clinically significant abnormal finding occurring during the screening period and/or observed at the baseline visit that may put the participant at risk due to their participation in the trial or could influence the participant's ability to complete the trial.\n* Positive hepatitis B surface antigen and/or hepatitis B core antibody and positive hepatitis B virus DNA (participants who have tested positive for hepatitis B core antibody are eligible if tests for hepatitis B surface antigen and hepatitis B virus DNA are negative) or positive hepatitis C virus antibody serology confirmed by hepatitis C virus RNA at screening.\n* Known or suspected hypersensitivity to any component(s) of the IMP.\n* Current or recent chronic alcohol or drug abuse, or any other condition associated with poor compliance as judged by the investigator.\n* Women who are pregnant or lactating.\n* Systemic treatment within 4 weeks prior to baseline with immunosuppressive drugs (e.g., methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g., acitretin), tyrosine kinase inhibitors, phosphodiesterase-4 inhibitors, or corticosteroids (steroid eye drops and inhaled or intranasal steroids in the doses recommended in the product prescribing information for the treatment of allergic conjunctivitis, asthma, or rhinitis are allowed).\n* Use of tanning beds or phototherapy (e.g., ultraviolet B \\[UVB\\], ultraviolet A1 \\[UVA1\\], psoralen ultraviolet A \\[PUVA\\]) on the palms or soles within 4 weeks prior to baseline.\n* Use of systemic or topical janus kinase inhibitors (including delgocitinib/LEO 124249) within 4 weeks prior to baseline.\n* Cutaneously applied treatment with immunomodulators (e.g., phosphodiesterase-4 \\[PDE-4\\] inhibitors, pimecrolimus, tacrolimus, tapinarof, vitamin D3 derivatives) or TCS on the palms or soles within 2 weeks prior to baseline.\n* Use of systemic antibiotics or cutaneously applied antibiotics on the palms or soles within 2 weeks prior to baseline.\n* Other transdermal or cutaneously applied therapy on the palms or soles (except for the use of the participant's own non-medicated emollients) within 1 week prior to baseline.\n* Cutaneously applied treatments in regions other than the palms or soles, which could interfere with clinical trial evaluations or pose a safety concern (excluding treatments for psoriasis patches or other non-exclusionary skin conditions, if needed) within 1 week prior to baseline.\n* Treatment with any marketed biological therapy or investigational biologic agents:\n\n  * Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.\n  * Other biologics, including but not limited to secukinumab, ustekinumab, tildrakizumab, ixekizumab, risankizumab, guselkumab, and tumour necrosis factor (TNF)-alpha inhibitors: within 3 months or 5 half-lives, whichever is longer, prior to baseline.\n* Treatment with any non-marketed drug substance (i.e., an agent that has not yet been made available for clinical use following registration) within the last 4 weeks prior to baseline or 5 half-lives, whichever is longer.\n* Current participation in any other interventional clinical trial.\n* Previously randomised in this clinical trial.\n* Previously randomised in a clinical trial with delgocitinib.\n* Employees of the trial site, or any other individuals directly involved with the planning or conduct of the trial, or immediate family members of such individuals.","locations":[{"facility":"LEO Pharma Investigational Site","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigational Site","city":"Douglasville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigational Site","city":"West Bloomfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigational Site","city":"Elmhurst","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigation Site","city":"Mayfield Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigational Site","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LEO Pharma Investigational Site","city":"Philadelphia","state":"Pennsylvania","country":"United 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16"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["fountain-valley-california","douglasville-georgia","west-bloomfield-michigan","elmhurst-new-york","mayfield-heights-ohio","portland-oregon","philadelphia-pennsylvania","calgary-canada","edmonton-canada","surrey-canada","winnipeg-canada","fredericton-canada","hamilton-canada","markham-canada","waterloo-canada","montreal-canada","bad-bentheim-germany","dresden-germany","g-ttingen-germany","hamburg-germany","kiel-germany","l-beck-germany","manheim-germany","m-nster-germany","osnabr-ck-germany","witten-germany","bialystok-poland","iwonicz-zdr-j-poland","lodz-poland","lublin-poland","rzesz-w-poland","warsaw-poland","wroclaw-poland","bristol-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","salford-united-kingdom","stourbridge-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Delgocitinib cream for Palmoplantar Pustulosis","inPlainEnglish":"The main objective of the study is to measure the how well it works of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP). Total study duration for each you would be approximately 18 weeks, for an approximate total of 9 visits.","whoItsFor":["Ages 18 Years to any","Participant is able to comply with clinic visits and trial requirements and procedures, as assessed by the investigator","Confirmed PPP by central evaluation of photographs taken at screening","Mild to severe PPP current condition defined by:","Disease duration of PPP of \\>6 months before randomisation","PPP-PGA of at least mild severity (PPP-PGA ≥2) at screening and baseline","PPPASI ≥8 at screening and baseline","Presence of ≥5 well-demarcated fresh pustules (white or yellow pustules) in total across all affected areas at screening and baseline"],"whoShouldSkip":["Presence or known history of drug-induced PPP (e.g., a new onset of PPP or an exacerbation of PPP from beta blockers, calcium channel blockers, lithium, or biologic therapy including infliximab, adalimumab, or etanercept)","Presence of acrodermatitis continua of Hallopeau","Active dermatologic condition that could confound the diagnosis of PPP or interfere with assessment of the IMP, as assessed by the investigator","Clinically significant infection on the palms or soles","Concurrent plaque psoriasis covering \\>5% of body surface area","A systemic infection","A serious skin infection requiring parenteral (intravenous or intramuscular) antibiotics, antiviral, or antifungal medication"],"whatHappens":"If you join, the listed intervention(s) are Delgocitinib cream, or Vehicle cream. The registry lists allocation as randomized. The main objective of the study is to measure the how well it works of twice daily applications of delgocitinib cream 20 mg/g compared with cream vehicle in the treatment of adult participants with mild to severe palmoplantar pustulosis (PPP).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 135 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.572Z"},{"nctId":"NCT07015905","title":"REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults","officialTitle":"A Phase 3, Multicenter, Randomized, Open-Label, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called REGN7508 (called \"study drug\"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.\n\nThe aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)","conditions":["Venous Thromboembolism (VTE)"],"keywords":["Unilateral Total Knee Arthroplasty (TKA)","Factor XI (FXI)"],"interventions":[{"type":"DRUG","name":"REGN7508"},{"type":"DRUG","name":"Apixaban"},{"type":"DRUG","name":"Enoxaparin"},{"type":"DRUG","name":"Placebo"}],"enrollment":2000,"startDate":"2025-06-25","completionDate":"2027-02-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Is undergoing a primary elective unilateral TKA\n2. Is in good health based on laboratory safety testing as described in the protocol\n3. Body weight ≤130 kg at screening visit as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation\n2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol\n3. History of thromboembolic disease or thrombophilia\n4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization\n5. Has an estimated Glomerular Filtration Rate (GFR) of \\<30 mL/min/1.73 m2 at the screening visit as described in the protocol\n\nNote: Other protocol-defined Inclusion/ Exclusion Criteria apply","locations":[{"facility":"Shoals Medical Trials, Inc.","city":"Sheffield","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CARI Clinical Trials","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Denver Metro Orthopedics, P.C. Englewood Location","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Delray Physician Care Center","city":"Delray Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partner","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sacred Heart Health System Inc","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gulfcoast Research Institute","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phoenix Clinical Research","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sinai Hospital of Baltimore, Inc.","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Curalta Clinical Trials","city":"Westwood","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Health System (Duke Health), Duke University Hospital","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keystone Clinical Studies LLC, dba Flourish Research","city":"Plymouth Meeting","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"HD Research - First Surgical Hospital","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas (UT); Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NextStage Clinical Research, All American Orthopedics and Sports Medicine","city":"Houston","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Futuro Clinical Trials","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research - San Antonio (Formerly Clinical Trials of Texas)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DRx Clinical Research, LLC; South Texas Bone and Joint Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DRx Clinical Research, LLC","city":"St. George","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multi-profile Hospital for Active Treatment Hearth and Brain EAD","city":"Pleven","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multiprofile Hospital for Active Treatment; Sveta Sofia EOOD (MBAL Sveta Sofia),","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Multiprofile Hospital for Active Treatment \"Prof. Dr. Stoyan Kirkovich\"","city":"Stara Zagora","state":"","country":"Bulgaria","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Szegedi Tudomanyegyetem; Albert Szent-Gyorgyi Clinical Center","city":"Szeged","state":"Csongrad-Csanad","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gyor-Moson-Sopron Varmegyei Egyetemi Oktato Korhaz","city":"Győr","state":"Győr-Moson-Sopron","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Debrecen","city":"Debrecen","state":"Hajdú-Bihar","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis University","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Rosai Hospital","city":"Amagasaki-shi","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yuuai Medical Center","city":"Tomigusuku","state":"Okinawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Osaka Minami Medical Center","city":"Kawachi-Nagano","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Saiseikai Nakatsu Hospital","city":"Kita-Ku","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saga University Hospital","city":"Saga","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liepajas regionala slimnica; SIA","city":"Liepāja","state":"","country":"Latvia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigas 2 slimnica, SIA","city":"Riga","state":"","country":"Latvia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of Traumatology and Orthopaedics","city":"Riga","state":"","country":"Latvia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ORTO Klinika","city":"Riga","state":"","country":"Latvia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vidzemes slimnica","city":"Valmiera","state":"","country":"Latvia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lietuvos sveikatos mokslu universiteto Kauno ligonine","city":"Kaunas","state":"","country":"Lithuania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik","city":"Kaunas","state":"","country":"Lithuania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vsi Klaipedos Universitetine Ligonine","city":"Klaipėda","state":"","country":"Lithuania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie sp. z o.o.","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny nr.2 Uniwersytetu Medycznego w Lodzi","city":"Lodz","state":"","country":"Poland","status":"COMPLETED","lat":null,"lon":null},{"facility":"Samodzieny Publiczny Zaklad Opieki Zdorowotne (SP ZOZ) Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi - Hematology","city":"Lodz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi Uniwersytetu Medycznego w Poznaniu","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arensia Clinics S.R.L","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARENSIA Exploratory Medicine, County Hospital Cluj-Napoca","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["sheffield-alabama","riverside-california","englewood-colorado","delray-beach-florida","miami-florida","pensacola-florida","sarasota-florida","tamarac-florida","baltimore-maryland","boston-massachusetts","westwood-new-jersey","durham-north-carolina","plymouth-meeting-pennsylvania","bellaire-texas","dallas-texas","houston-texas","mcallen-texas","san-antonio-texas","st-george-utah","pleven-bulgaria","sofia-bulgaria","stara-zagora-bulgaria","szeged-hungary","gy-r-hungary","debrecen-hungary","budapest-hungary","amagasaki-shi-japan","tomigusuku-japan","kawachi-nagano-japan","kita-ku-japan","bunkyo-ku-japan","saga-japan","liep-ja-latvia","riga-latvia","valmiera-latvia","kaunas-lithuania","klaip-da-lithuania","krakow-poland","lodz-poland","poznan-poland","bucharest-romania","cluj-napoca-romania"],"enrichment":{"headline":"Phase 3: testing REGN7508 for Venous Thromboembolism (VTE)","inPlainEnglish":"This study is researching an experimental drug called REGN7508 (called \"study drug\"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.","whoItsFor":["Ages 18 Years to any","Is undergoing a primary elective unilateral TKA","Is in good health based on laboratory safety testing as described in the protocol","Body weight ≤130 kg at screening visit as described in the protocol"],"whoShouldSkip":["Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation","History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol","History of thromboembolic disease or thrombophilia","History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization","Has an estimated Glomerular Filtration Rate (GFR) of \\<30 mL/min/1.73 m2 at the screening visit as described in the protocol","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are REGN7508, Apixaban, or Enoxaparin. The registry lists allocation as randomized. This study is researching an experimental drug called REGN7508 (called \"study drug\").","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,000 people at 47 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.992Z"},{"nctId":"NCT07015996","title":"Efficacy of Tezepelumab in Peanut Oral Immunotherapy","officialTitle":"Efficacy of Tezepelumab in Peanut Oral Immunotherapy: a Double-Blind, Randomized, Placebo-Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"The proposed study is a proof-of-concept Phase 2, double-blind, randomized placebo-controlled clinical trial evaluating the safety and efficacy of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a monotherapy period comprised of injections of either Tezepelumab or placebo from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 12 weeks. This study will enroll 62 peanut-allergic individuals from 12 to 55 years of age who experience dose-limiting symptoms to \\<=100 mg of peanut protein in a single dose (\\<= 144 mg cumulative dose) as assessed by DBPCFC.\n\nThe primary objective is to determine whether 56 weeks of tezepelumab plus peanut OIT as compared to 56 weeks of placebo plus peanut OIT induces sustained unresponsiveness to peanut 12 weeks after stopping combination therapy.","conditions":["Peanut Allergy"],"keywords":["Tezepelumab","Peanut","Oral Immunotherapy"],"interventions":[{"type":"BIOLOGICAL","name":"Tezepelumab"},{"type":"DRUG","name":"Peanut Oral Immunotherapy (OIT)"},{"type":"BIOLOGICAL","name":"Placebo for Tezepelumab"}],"enrollment":62,"startDate":"2026-07-27","completionDate":"2029-05","sex":"ALL","minAge":"12 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant and/or parent/legal guardian must be able to understand and provide informed consent (parental permission and informed assent of minor, if applicable).\n2. Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion\n3. A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC\n4. A negative challenge to the placebo (oat) during the Screening DBPCFC\n5. Sensitization to peanut as evidenced by either one of the following:\n\n   1. positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, or\n   2. wheal ≥ 3 mm on skin prick test to peanut extract compared to a negative control\n6. Female participants of childbearing potential must have a negative pregnancy test upon study entry\n7. Female participants with reproductive potential must agree to use an FDA approved method of contraception for the duration of the study\n8. Willing and able to comply with the study protocol requirements\n9. Participants with other food allergies must agree to continue avoidance of these food items from their diet to avoid confounding the safety and efficacy data of the study\n\nExclusion Criteria:\n\n1. Currently in build-up phase of aeroallergen immunotherapy\n2. Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months\n3. Pregnant, planning a pregnancy during the study, or breast-feeding\n4. History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG biologics, or rescue medications and their excipients\n5. Allergy to oat (participant reported)\n6. History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension requiring intensive care unit admission\n7. Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents)\n8. History of a life-threatening asthma attack within 12 months prior to screening (e.g., requiring an ICU admission or intubation with mechanical ventilation), need for oral corticosteroids for asthma management within the last 6 months, or current Asthma Control Test score less than 19 at screening\n9. History of ischemic cardiovascular disease or other cardiac disease, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study\n10. History of eosinophilic gastrointestinal disease at screening\n11. History of disease affecting the immune system such as autoimmune disease (e.g., systemic lupus erythematosus), immune complex disease (e.g., serum sickness), or immunodeficiency, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study\n12. History of malignancy of any type, excluding basal cell and squamous cell cancers of the skin that only required surgical excision or in situ carcinoma of the cervix study provided that curative therapy was completed at least 12 months prior to screening\n13. Current known helminth infection\n14. Positive QuantiFERON - TB Gold test or TB Gold Plus, or T-SPOT® TB test unless the potential participant has been treated with appropriate chemoprophylaxis. In the case of an indeterminate or borderline Interferon Gamma Release Assay (IGRA), an IGRA may be repeated.\n15. Any of the following:\n\n    1. HIV\n    2. Current or prior infection with hepatitis B virus (HBV)\n    3. Current or prior infection with hepatitis C virus (HCV), except adequately treated HCV with sustained virologic response ≥ 12 weeks.\n16. Active liver disease, defined as either:\n\n    1. AST, ALT, and/or Alk phos \\>2x ULN, or\n    2. other active liver disease which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study\n17. Any of the following:\n\n    1. Current use of beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin-receptor blockers\n    2. Received any investigational product within the past 4 months or 5 half-lives (whichever is longer) prior to screening\n    3. Received systemic corticosteroids within 14 days prior to screening\n    4. Receipt of immunoglobulin or other blood product within 30 days prior to screening\n    5. Receipt of live attenuated vaccine within 30 days prior to screening\n    6. Use of an immunosuppressant or immunomodulating drug within 30 days prior to screening\n    7. Use of biologics targeting the human immune system within the past 12 months prior to screening\n    8. Use of any herbal medications, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study\n18. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study","locations":[{"facility":"Arkansas Children's Hospital Research Institute: Department of Pediatrics, Allergy & Immunology","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles: Department of Medicine, Division of Clinical Immunology and Allergy","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Children's Center: Department of Allergy & Immunology","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital: Department of Medicine: Allergy & Clinical Immunology Unit","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital: Allergy and Asthma Program","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Michigan: Division of Allergy and Clinical Immunology","city":"Ann Arbor","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai: Department of Pediatrics Allergy & Immunology","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Carolina Children's Hospital: Department of Pediatrics, Division of Allergy, Immunology and Rheumatology","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center: Division of Allergy and Immunology","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center: Division of Allergy and Immunology","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Consumption of a cumulative dose of 4000 mg of peanut protein without dose-limiting symptoms during the open Oral Food Challenge (OFC)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["tezepelumab"],"locationSlugs":["little-rock-arkansas","los-angeles-california","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","new-york-new-york","chapel-hill-north-carolina","cincinnati-ohio","dallas-texas"],"enrichment":{"headline":"Phase 2: testing Tezepelumab for Peanut Allergy","inPlainEnglish":"The proposed study is a proof-of-concept Phase 2, neither you nor the study doctors know who gets the real treatment, randomly assigned compared with a dummy treatment clinical trial evaluating the safety and how well it works of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy. Study participation is divided into 3 periods: (i) a this drug alone period comprised of injections of either Tezepelumab or dummy treatment (placebo) from week 0 to week 8, (ii) followed by a combination therapy period comprised of 56 weeks during which peanut OIT is built up and maintained, and (iii) a treatment withdrawal period comprised of 12 weeks.","whoItsFor":["Ages 12 Years to 55 Years","Age 12 to 55 years inclusive with a personal history of an allergic reaction to peanut ingestion","A positive reaction at or below ingestion of 100 mg of peanut protein in a single dose (≤ 144 mg cumulative dose) during the Screening DBPCFC","A negative challenge to the dummy treatment (placebo) (oat) during the Screening DBPCFC","Sensitization to peanut as evidenced by either one of the following:","positive sIgE to Ara h2 ≥ 0.35 kU/L by ImmunoCAPTM testing, or","wheal ≥ 3 mm on skin prick test to peanut extract compared to a negative control","Female participants of childbearing potential must have a negative pregnancy test upon study entry"],"whoShouldSkip":["Currently in build-up phase of aeroallergen immunotherapy","Current food allergen immunotherapy or use of any food allergen immunotherapy within the past 12 months","Pregnant, planning a pregnancy during the study, or breast-feeding","History of intolerance, hypersensitivity, or allergic reactions to tezepelumab, or the inactive ingredients (excipients) of tezepelumab, other IgG biologics, or rescue medications and their excipients","Allergy to oat (participant reported)","History of severe systemic allergic reaction to peanut with symptoms including the need for mechanical ventilation and/or severe hypotension requiring intensive care unit admission","Asthma requiring high dose inhaled corticosteroid therapy for control (2007 NHLBI Criteria Steps 5 or 6 in adults and adolescents)"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab, Peanut Oral Immunotherapy (OIT), or Placebo for Tezepelumab. The registry lists allocation as randomized. The proposed study is a proof-of-concept Phase 2, neither you nor the study doctors know who gets the real treatment, randomly assigned compared with a dummy treatment clinical trial evaluating the safety and how well it works of tezepelumab and peanut Oral Immunotherapy (OIT) for the treatment of peanut allergy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 62 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.859Z"},{"nctId":"NCT07018869","title":"Evaluating Whether an Educational Website Called Current Together After Cancer (CTAC) Improves Follow-up Care for Colorectal Cancer Survivors","officialTitle":"A Pragmatic Randomized Controlled Trial to Evaluate the Effectiveness of an Intervention Called Current Together After Cancer (CTAC) to Promote Guideline-Concordant Colorectal Cancer Surveillance","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"SWOG Cancer Research Network","sponsorClass":"NETWORK","summary":"This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant). Surveillance care after resection of colorectal cancer is critical to detect potentially curable return of disease (recurrence), yet up to 60% of colorectal cancer survivors fail to receive surveillance. This may be due to a lack of knowledge about the purpose of surveillance care and the risks of cancer recurrence, or a lack of confidence for managing surveillance care. The CTAC intervention is an online education intervention designed to improve patients' knowledge about surveillance and their self-efficacy for managing surveillance, and to promote effective communication with supporters and supporter engagement in patients' surveillance in a way that is aligned with each patient's preferences. By increasing a patient's knowledge, self-efficacy, and satisfaction with their supporter's engagement in their care, the CTAC intervention may increase the number of patients who receive guideline-concordant surveillance care after resection of colorectal cancer.","conditions":["Colorectal Cancer Stage II","Colorectal Cancer Stage III"],"keywords":[],"interventions":[{"type":"OTHER","name":"Intervention website access"},{"type":"OTHER","name":"Control website access"},{"type":"OTHER","name":"Interview"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":1057,"startDate":"2025-10-15","completionDate":"2031-10-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* PATIENTS:\n* Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below\n* Patient participants must have an adult in their life who supports them in their colorectal cancer journey who they might be willing to invite to join them in viewing an educational website. This is determined via the question: \"Do you have an adult in your life, such as a spouse/partner, family member or friend, who supports you with your colorectal cancer journey and may be willing to view a website with you? When we say, \"supports you in your colorectal cancer journey\", we mean things like, helping you keep and get to medical appointments, talking with you and/or your doctors about your cancer, or helping you make decisions about your cancer.\"\n\n  * Those who respond \"no\" to the question above will be told that \"Because this study is for patients and a supporter to view the website together, you are not eligible for this study, but there may be other studies you are eligible for in the future\".\n  * NOTE: The above question will be used to define \"supporter\" for purposes of this study. Examples of supporters include a spouse, partner, sibling, adult child, another family member, or friend.\n  * NOTE: The supporter does not have to agree to participate in the study in order for the patient to be eligible for this study. Justification for requiring the enrolled patient to have a supporter (whether the supporter is invited or participates) is based on the study's underlying conceptual framework\n* Patient participants must not have recurrent or metastatic (stage IV) colorectal cancer\n* Patient participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the efficacy assessment of this intervention\n* Patient participants must be registered within 90 - 180 days of surgical resection\n* Patient participants must be ≥ 18 years of age at the time of registration/randomization. The lower cutoff of 18 was determined because the lower age range of patients that may be recruited to Southwest Oncology Group (SWOG) studies is 18\n* Patient participants must have Zubrod performance status of 0-2\n* Patient participants must be able to read English or Spanish since the website for the intervention and control arm are available in English and Spanish\n* Patient participants must: 1) be able to complete Patient Reported Outcome (PRO) questionnaires in English or Spanish, and 2) agree to complete PROs at all scheduled timepoints\n* Patient participants will be encouraged to provide an email address or cell phone number, if possible, for the purpose of being contacted by staff at the University of Michigan who will provide access to the educational website. For those who do not wish to provide or create an email address or a cell phone number, they may still participate with alternate methods\n* Patient participants must not be enrolled or be planning to enroll in a clinical trial of investigational treatment that includes imaging and/or laboratory monitoring for the duration of this trial\n\n  * NOTE: Patient participants are allowed to be co-enrolled on other non-treatment clinical trials\n* SUPPORTER PARTICIPANT:\n* Supporter participants must be ≥ 18 years of age at the time of registration/randomization\n* Supporter participants must be able to read English or Spanish since the educational website is available in English and Spanish\n* Supporter participants must have been identified by the patient as a person who may be willing to join them in reviewing the educational website\n* PATIENT AND SUPPORTER:\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Patient and supporter participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. This protocol does not permit use of Legally Authorized Representative","locations":[{"facility":"Anchorage Associates in Radiation Medicine","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Breast Care and Surgery LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology LLC","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katmai Oncology Group","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Alaska Medical Center","city":"Anchorage","state":"Alaska","country":"United 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University Medical Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Georgia Medical Center Braselton","city":"Braselton","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Georgia Medical Center-Gainesville","city":"Gainesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Longstreet Clinic - Gainesville","city":"Gainesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Health University Medical Center","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hawaii Cancer Care Inc - Waterfront Plaza","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen's Cancer Cenrer - POB 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3: Intervention website access for Colorectal Cancer Stage II","inPlainEnglish":"This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant). Surveillance care after resection of colorectal cancer is critical to detect potentially curable return of disease (recurrence), yet up to 60% of colorectal cancer survivors fail to receive surveillance.","whoItsFor":["Ages 18 Years to any","Patient participants must have newly diagnosed surgically resected, stage II or stage III colorectal cancer per the timing described below","Those who respond \"no\" to the question above will be told that \"Because this study is for patients and a supporter to view the website together, you are not eligible for this study, but there may be other studies you are eligible for in the future\"","NOTE: The above question will be used to define \"supporter\" for purposes of this study. Examples of supporters include a spouse, partner, sibling, adult child, another family member, or friend","Patient participants must not have recurrent or metastatic (stage IV) colorectal cancer","Patient participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the how well it works assessment of this intervention","Patient participants must be registered within 90 - 180 days of surgical resection","Patient participants must be ≥ 18 years of age at the time of registration/randomization. The lower cutoff of 18 was determined because the lower age range of patients that may be recruited to Southwest Oncology Group (SWOG) studies is 18"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Intervention website access, Control website access, or Interview. The registry lists allocation as randomized. This phase III trial evaluates whether a web-based intervention called Current Together after Cancer (CTAC) works to increase the number of patients with surgically removed (resected) colorectal cancer who receive surveillance care that aligns with current guidelines (guideline-concordant).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,057 people at 384 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.075Z"},{"nctId":"NCT07020221","title":"A Phase 1/2 Study of VS-7375 in Patients With KRAS G12D-Mutated Solid Tumors","officialTitle":"A Phase 1/2, Open-label Study of VS-7375, a KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and in Combination, in Patients With Advanced KRAS G12D-Mutated Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Verastem, Inc.","sponsorClass":"INDUSTRY","summary":"This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.","conditions":["Pancreatic Ductal Adenocarcinoma","Non Small Cell Lung Cancer","Colorectal Cancer","Solid Tumor, Adult","G12D Mutated KRAS"],"keywords":["KRAS G12D mutation","Solid tumors","Non Small Cell Lung Cancer","Lung Cancer","Colorectal Cancer","Metastatic Cancer","Pancreatic Cancer","Pancreatic Ductal Adenocarcinoma","NSCLC","CRC","PDAC","Pancreatic Neoplasms","Colorectal Neoplasms","Lung Neoplasms","Gastrointestinal Neoplasms","KRAS","RAS","Biliary Tract Cancer","BTC","Biliary Tract Neoplasms","Intrahepatic cholangiocarcinoma","Appendiceal Cancer","Endometrial Cancer","Small bowel Cancer"],"interventions":[{"type":"DRUG","name":"VS-7375"},{"type":"DRUG","name":"Cetuximab"},{"type":"DRUG","name":"Carboplatin + Pemetrexed + Pembrolizumab"},{"type":"DRUG","name":"Gemcitabine + Nab-paclitaxel"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Defactinib"},{"type":"DRUG","name":"Midazolam"},{"type":"DRUG","name":"Repaglinide"}],"enrollment":616,"startDate":"2025-06-24","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Individuals ≥18 years of age.\n* Agreement to sign and date an informed consent form (ICF) approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).\n* Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation.\n* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Adequate organ function\n* Adequate cardiac function\n* Recovered from all AEs due to previous therapies to Grade ≤1 or baseline\n* Agreement to use highly effective contraception\n\nKey Exclusion Criteria:\n\n* Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1\n* Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1.\n* Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1.\n* History of treatment with direct RAS inhibitors.\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases.\n* Inability to swallow oral medications.\n* Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease.\n* Individuals who are pregnant or breastfeeding.","locations":[{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laura & Isaac Perlmutter Cancer Center at NYU Langone","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univ of Pennsylvania, Abramson Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Mason Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula and Southeast Oncology","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Leon Berard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre d'Essais Precoces en Cancerologie de Marseille (CEPCM)","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall d'Hebron Instituto de Oncología","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Rioja - Hospital Universitario San Pedro","city":"Logroño","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid - FJD","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid CIOCC - Hospital HM Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Verastem Call Center","phone":"1 781 292 4204","email":"clinicaltrials@verastem.com"}],"primaryOutcomes":["Part A: To characterize the safety, tolerability, and AE profile of escalating doses of VS-7375","Part A: To identify the MTD or MFD","Part B: To evaluate the preliminary anticancer activity of the optimal VS-7375 regimen","Part C: To characterize the safety, tolerability, and AE profile of VS-7375 in combination regimens.","Part C: To identify a recommended dose for subsequent studies of combination dosed VS-7375.","Part D: To determine the preliminary anticancer activity of the optimal regimen of VS-7375 as identified in Part C","Part E: To determine the impact of VS-7375 on the PK of midazolam or repaglinide","Part E: To determine the impact of VS-7375 on the PK of midazolam or repaglinide","Part E: To characterize the safety, tolerability, and AE profile of VS-7375 administered in combination with CYP3A4 and CYP2C8 substrates","Part F: Serial biopsy"],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer","pancreatic-cancer","endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["los-angeles-california","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","st-louis-missouri","new-york-new-york","philadelphia-pennsylvania","nashville-tennessee","houston-texas","salt-lake-city-utah","charlottesville-virginia","fairfax-virginia","seattle-washington","sydney-australia","frankston-australia","lyon-france","marseille-france","paris-france","barcelona-spain","logro-o-spain","madrid-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing VS-7375 for Pancreatic Ductal Adenocarcinoma","inPlainEnglish":"This study will assess the safety and how well it works of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.","whoItsFor":["Ages 18 Years to any","Individuals ≥18 years of age","Histologic or cytologic evidence of locally advanced unresectable or metastatic solid tumor harboring a KRAS G12D mutation","Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1","Adequate organ function","Adequate cardiac function","Recovered from all AEs due to previous therapies to Grade ≤1 or baseline"],"whoShouldSkip":["Underwent major surgical procedure as defined by the Investigator, other than for diagnosis, within 4 weeks prior to Cycle 1 Day 1","Receipt of chemotherapy, targeted therapy, or radiotherapy (excluding palliative radiation) within 4 weeks or 5 half-lives, whichever is shorter, or immunotherapy within 4 weeks prior to Cycle 1 Day 1","Treatment with any investigational drug at least 4 weeks or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1","History of treatment with direct RAS inhibitors","Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases","Inability to swallow oral medications","Evidence or history of uncontrolled, clinically significant hematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation, neurologic, dermatologic, autoimmune, or allergic disease"],"whatHappens":"If you join, the listed intervention(s) are VS-7375, Cetuximab, or Carboplatin + Pemetrexed + Pembrolizumab. The registry lists allocation as randomized. This study will assess the safety and how well it works of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 616 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.714Z"},{"nctId":"NCT07021014","title":"NightWare and Cardiovascular Health in Women With PTSD","officialTitle":"Improving Cardiovascular Health in Women With PTSD by Treating Trauma-Related Nightmares With NightWare","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.","conditions":["Post Traumatic Stress Disorder","Cardiovascular Diseases","Autonomic Dysfunction","Vascular Stiffness","Nightmare","Endothelial Dysfunction","Kidney Diseases","Renal Dysfunction","Trauma and Stressor Related Disorders"],"keywords":["Sleep","Trauma and Stressor Related Disorders","Post Traumatic Stress Disorder","Cardiovascular Diseases","Kidney Diseases","Renal Dysfunction","Autonomic Dysfunction"],"interventions":[{"type":"DEVICE","name":"NightWare"},{"type":"DEVICE","name":"Sham NightWare"}],"enrollment":36,"startDate":"2025-08-06","completionDate":"2028-07","sex":"FEMALE","minAge":"22 Years","maxAge":"40 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Healthy, as determined by medical history\n* Group Specific Eligibility\n* PTSD Group\n* Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)\n* Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)\n* Self-report having repetitive nightmares contributing to disrupted sleep\n* Poor overall sleep quality: PSQI score 6 or higher\n* Control Group\n* No lifetime PTSD: screened using PC-PTSD-5\n* No prior trauma exposure: screened using BTQ\n* Do not self-report having repetitive nightmares contributing to disturbed sleep\n\nExclusion Criteria:\n\n* Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes\n* Body Mass Index ≥ 40 kg/m2\n* Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)\n* Active infection (note, anyone with an active infection would become eligible once the infection has ended)\n* Abnormal thyroid, liver, or kidney function testing during the screening examination or bloodwork. Abnormal kidney function defined as creatinine \\>1.3mg/dL. Abnormal liver function tests within 1.5x ULN. UCH Clinical Lab ULN for AST and ALT are 39 and 52, respectively. Women with TSH levels outside of the normal range (0.5-5.0 mLU/L) will be referred to their PCP and will be allowed study entry once their TSH levels are normalized \\> 3 months\n* Plasma glucose \\>126 mg/dl under fasting conditions\n* Use of insulin or sulfonylureas\n* Pregnant, within 12 months postpartum or currently breast feeding\n* Current history of substance (excluding marijuana) or alcohol abuse per the SCID-5. Adults with past substance or alcohol use disorders will be allowed to participate.\n* Report elevated acute risk for suicidal self-directed violence warranting immediate hospitalization (e.g., suicidal ideation with intent, evaluated by the C-SSRS).\n* Shift workers\n* Diagnosis of active disorder of arousal from non-rapid eye movement sleep, rapid eye movement sleep behavior disorder, or narcolepsy\n* Nocturia that causes awakening from sleep\n* Epworth Sleepiness Scale: Question #8 score above \"0\" will prompt an additional question: Do you drive (\"get behind the wheel\") when you are drowsy? The answer must be \"No\" to be enrolled in the study due to safety concerns\n* Known sleep walking or acting out dreams (contraindication to NightWare use)\n* Diagnosis or suspicion of dementia\n* Participants experiencing severe cognitive impairment or current psychiatric symptoms of such severity that would preclude participation (e.g., active psychosis, imminently suicidal)\n* Current use of vitamin/supplements (including melatonin) or anti-inflammatory medications, participants will be included if they are willing to stop taking vitamin/supplements or anti-inflammatory medications 2 weeks prior to the first vascular visit.\n* Current or planned participation in an interventional study during the present study\n* Participants must have access to wireless internet and two power outlets where they sleep","locations":[{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado CCTSI CTRC","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily Larson, PhD","phone":"7205233224","email":"emily.a2.larson@cuanschutz.edu"},{"name":"Kerrie Moreau, PhD","phone":"","email":"kerrie.moreau@cuanschutz.edu"}],"primaryOutcomes":["Brachial artery flow-mediated dilation (FMD)"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["aurora-colorado","denver-colorado"],"enrichment":{"headline":"Not a traditional drug phase: NightWare for Post Traumatic Stress Disorder","inPlainEnglish":"This study wants to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.","whoItsFor":["Ages 22 Years to 40 Years","Women only","Healthy, as determined by medical history","Group Specific Eligibility","Lifetime PTSD: screened using Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) and confirmed via Clinician Administered PTSD Scale for DSM-5 (CAPS-5)","Prior trauma exposure: screened using Brief Trauma Questionnaire (BTQ)","Self-report having repetitive nightmares contributing to disrupted sleep","Poor overall sleep quality: PSQI score 6 or higher","No lifetime PTSD: screened using PC-PTSD-5"],"whoShouldSkip":["Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer) or systemic illness that would interfere with interpretation of the study outcomes","Body Mass Index ≥ 40 kg/m2","Use of medications that might influence cardiovascular or renal function (i.e., antihypertensive, lipid lowering medications, GLP-1/GIP RAs)","Active infection (note, anyone with an active infection would become eligible once the infection has ended)","Plasma glucose \\>126 mg/dl under fasting conditions","Use of insulin or sulfonylureas","Pregnant, within 12 months postpartum or currently breast feeding"],"whatHappens":"If you join, the listed intervention(s) are NightWare, or Sham NightWare. The registry lists allocation as randomized. This study wants to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.406Z"},{"nctId":"NCT07021495","title":"SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","officialTitle":"A Prospective, Multi-Center, Observational Biomarker Real-World Evidence Study for In-Depth Profiling of Patients With Chronic Immune-Mediated Inflammatory Skin Diseases in Daily Practice","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Leiden University Medical Center","sponsorClass":"OTHER","summary":"The goal of this observational study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers. This study is part of the larger NGID (Next Generation ImmunoDermatology) initiative, of which the main objective is to develop infrastructure that enables personalised patient care. The main questions the SKINERGY study aims to answer are:\n\n* Which biomarkers can discriminate between responders and non-responders to treatment in patients with AD, CLE, CSU, HS, MF, and PSO?\n* How do disease-related biomarkers in patients with AD, CLE, CSU, HS, MF, and PSO differ from those in healthy volunteers?\n* Which (multi-omics) biomarkers are associated with disease subtypes and predict response or non-response to (targeted) therapies in daily clinical practice?\n* How do biomarker profiles compare across different cohorts of patients with immune-mediated inflammatory skin diseases (AD, CLE, CSU, HS, MF, PSO)\n* How do biomarker levels change over time in response to treatment in these patient populations?\n* Which skin tissue biomarkers are associated with disease progression or treatment response?\n* How do the genomic profiles of patients differ across diseases or correlate with treatment outcomes?\n* Can additional imaging biomarkers enhance the characterization of disease profiles or treatment monitoring over time?\n\nResearchers will compare both differences beween patients within a disease group in different treatment arms, as well as patients within the same treatment arm. Additionally, biomarker profiles of patients with different diseases will be evaluated. These comparisons will be made to see if shared or distinct biomarker patterns exist across diseases and treatments, which could inform patient stratification, optimize therapeutic decision-making, and identify potential targets for future interventions.\n\nParticipants will start medication according to national guidelines for the treatment of their inflammatory skin disease (AD: Cyclosporin A, anti-IL4/13, or anti-JAK; PSO: anti-TNF, anti-IL23, ani-IL17, anti-TYK2; HS: anti-TNF, anti-IL17; MF: CHLORM, TSC, PUVA-UV-B; CSU: anti-IgE, Cyclosporin A, anti-BTK\\*; CLE: TSC, HCQ, MTX)\n\n\\*once approved and reimbursed in the Netherlands\n\nParticipants will:\n\n* Take the prescribed medication for their skin disease (in line with standard care in the Netherlands).\n* Visit the clinic for a study visit combined with their standard care appointment 3 times (baseline, month 3, and month 6. An additional 4th visit at month 12 is optional).\n* Fill in an online set of questionnaires from home, 3 times during the study period (an additional 4th time is optional).\n* Patients with CSU fill in the UAS7 (and if applicable the AAS7) daily for the study period.","conditions":["Chronic Spontaneous Urticaria (CSU)","Hidradenitis Suppurativa (HS)","Psoriasis (PsO)","Atopic Dermatitis (AD)","CTCL/ Mycosis Fungoides"],"keywords":["Urticaria","Hives","Mast cells","Autoimmune","Autoallergic","Wheals","Angioedema","Abscess","Nodules","Sweat glands","Acne inversa","Eczema","Itchy, dry skin","Mycosis Fungoides","Skin patches","Tumors","T-cells","Lupus","Skin rash","Photosensitivity","Plaques","Scaling","Erythema","Induration","Inflammatory skin diseases","Immune-mediated","Deep phenotyping","Multi-omics","Transcriptomics","Lipidomics","Metabolomics","Proteomics","Genomics","Microbiomics","Imaging mass cytometry (CyTOF)","Real-world practice","Standard care","NextGenerationImmunoDermatology","NGID","Biomarkers"],"interventions":[],"enrollment":840,"startDate":"2025-07-29","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPatients:\n\n1. Able to understand and provide a written informed consent prior to any study procedures\n2. Male or non-pregnant female, ≥18 years of age\n3. Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day.\n4. Patient is willing and able to comply with the study protocol\n5. Female participants are willing to not get pregnant between M0 until M12, from study entry to the last study visit\n6. The patient is willing to start the prescribed treatment.\n\nDisease-specific inclusion criteria\n\nFor patients with AD:\n\nTo be eligible to participate in this study, a subject must meet all of the following criteria:\n\n6\\. Diagnosis and history of chronic, moderate-to-severe AD (by the Eichenfield revised criteria of Hanifin and Rajka for at least 3 years before baseline visit.\n\n7\\. Documented recent history (last 6 months) of eligibility for (local or systemic) treatment with immunosuppressants, biologics or JAK-inhibitors.\n\n8\\. When applicable, documented recent history (last 6 months) of inadequate response to treatment with topical therapy, immunosuppressants, biologics or JAK-inhibitors.\n\n9\\. Current treatment can include moisturizers, topical treatment and/or systemic treatments with preferable wash-out (see exclusion criterion #9). On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment.\n\n10\\. EASI≥7 (moderate-to-severe disease) 11. At least one suitable target lesion at the discretion of the investigator 12. Intention to start treatment with cyclosporine A, dupilumab, tralokinumab, lebrikizumab or a JAK1-inhibitor (abrocitinib or upadacitinib)\n\nFor patients with CLE:\n\nParticipants must have a diagnosis of CLE, including SCLE, CDLE or LET that fulfil the following:\n\n6\\. Confirmed CLE diagnosis by clinicopathological correlation. 7. An overall CLE Disease Area and Severity Index Activity (CLASI-A) Score ≥3 without counting any diffuse alopecia or oral ulcers.\n\n8\\. Intention to start treatment with TCS, hydroxychloroquine or methotrexate (combination or mono-treatment).\n\nIf participating in the exploratory study with the skin biopsy: location of the lesion(s) selected for biopsy preferably outside the facial area (possible are e.g., neck, chest, back, limbs, scalp, ear etc.).\n\nFor patients with CSU:\n\n6\\. Diagnosis of CSU (moderate to severe according to international guidelines (Zuberbier et al, 2022)) for ≥3 months and symptomatic disease despite treatment with second generation H1 antihistamines (up to fourfold the approved dose).\n\n7.Patients currently on an antihistamine (up to fourfold the approved dose) must be on a stable dose for at least 2 weeks prior to day 1 and must maintain the same stable dose throughout the treatment period.\n\n8\\. Intention to start (add-on to antihistamine) treatment of omalizumab, cyclosporine A or BTK inhibitor\\*. (\\*when approved and reimbursed in NL)\n\nFor patients with HS:\n\n6\\. Patient with a history of signs and symptoms consistent with moderate-to-severe HS, based on IHS4 score (Zouboulis et al., 2017), for at least 1 year prior to baseline 7. Current treatment can include topical treatment. On-study treatment is at physician and patient discretion but must include eligibility to starting systemic treatment 8. Intention to start treatment with anti-TNF or anti-IL17 (secukinumab, bimekizumab\\*) \\*when approved and reimbursed in NL.\n\nFor patients with MF:\n\n6\\. A confirmed diagnosis of CTCL MF type and stage classification via histology or clinicopathological correlation 7. For the stage IA-IIA CTCL patients: at least one patch and/or one plaque lesion is present 8. Intention to start treatment with topical chlormethine, topical corticosteroids or phototherapy (PUVA / UV-B).\n\nFor patients with PSO:\n\n6\\. Diagnosed with chronic plaque psoriasis at least 6 months prior to study participation 7. PASI≥5 with at least one suitable target lesion at the discretion of the investigator 8. Current treatment can include moisturizers, topical treatment and/or systemic treatments with preferable wash-out. On-study treatment is at physician and patient discretion but must include eligibility to starting new systemic treatment 9. Intention to start treatment with biologics: anti-TNF, anti-IL23, anti-IL17 or anti-TYK2\n\nHealthy volunteers:\n\nAll healthy volunteers must meet all of the following inclusion criteria:\n\n1. Signed informed consent before any study-mandated procedure.\n2. Male or non-pregnant female volunteers, ≥18 years of age\n3. Subject is in stable good health as per judgement of the investigator based upon the results of medical history and assessments performed at baseline.\n4. No clinically significant skin disease as judged by the investigator.\n5. No history of hypertrophic scarring or keloid.\n6. Subject is willing to refrain from extensively washing (including bathing, swimming) the skin 12 hours before every study visit.\n7. Subject is willing and able to wash out and withhold any topical treatment (prescription and over-the-counter products) in the investigational area for 2 weeks prior to Day 1.\n8. Subject is willing to refrain from application of any topical product (e.g. ointments, cream, or washing lotions) on the skin 24 hours prior to every study visit day.\n9. Subject is willing and able to wash out any antibiotic therapy for 14 days prior to Day 1.\n10. Subject is willing and able to comply with the study protocol.\n11. Female participants are willing to not get pregnant from study entry to the last study visit\n\nExclusion Criteria:\n\nPatients:\n\n1. Have any other relevant skin infection/disease in the treatment area other than the investigated skin disease.\n2. Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit.\n3. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator. 4. Having received treatments for the investigated skin disease within the following intervals prior to the start of the study is not a strict exclusion criterion since this is a real-world study. However, preferred intervals for washout are as follows:\n\n   * 1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors\n   * 4 weeks for phototherapy, e.g. UVB, PUVA, PDT\n   * 4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors\n   * 8 weeks for radiotherapy or surgery in the treatment area\n   * 8 weeks for biologics\n   * 3 months for any systemic chemotherapeutical treatment\n\nDisease specific exclusion criteria for patients with CLE:\n\n5\\. Diagnosed with SLE\n\nDisease specific exclusion criteria for patients with CSU:\n\n5\\. Treatment with omalizumab within 8 weeks prior to Day 1 6. Urticarial or angioedema symptoms such as urticarial vasculitis, erythema multiforme, cutaneous mastocytosis (urticaria pigmentosa) and hereditary, acquired angioedema or drug-induced (e.g., due to C1 esterase inhibitor deficiency, ACE-inhibitor induced).\n\nDisease specific exclusion criteria for patients with MF:\n\n5\\. Ongoing uncontrolled active skin infection, other than secondary impetiginized CTCL lesions as judged by the investigator\n\nDisease specific exclusion criteria for patients with PSO:\n\n5\\. Having primarily erythrodermic, pustular or guttate psoriasis; 6. Having drug-induced psoriasis;\n\nHealthy volunteers:\n\nAll healthy volunteers must meet none of the following exclusion criteria:\n\n1. History of immunological abnormality (e.g. immune suppression, severe allergy, or anaphylaxis) that may interfere with study objectives as per judgement of the investigator.\n2. History or symptoms of any uncontrolled, significant disease including (but not limited to), a neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may interfere with the study objectives as per judgement of the investigator.\n3. The use of systemic antibiotic therapy for \\>2 months in the past 12 months.\n4. The use of any immunosuppressive or immunomodulatory therapy within the past 30 days prior to Day 1.\n\n6\\. Loss or donation of blood over 500mL within three months prior to baseline. Participation in an investigational drug study within 3 months prior to baseline visit or more than 4 times a year.\n\n7\\. History of alcohol consumption exceeding 5 standard drinks per day on average within 3 months prior to baseline. Alcohol consumption will be prohibited for at least 24 hours preceding each study visit.\n\n8\\. Positive urine test for drugs or history of abuse at baseline. 9. Exposure to high doses of UV radiation is not permitted within 3 weeks of the first study visit until the end of the study 10. Extreme physical activities are not permitted within 48 hours before each study visit 11. Any other condition, disease, or known factor that could interfere with the study conduct or the study objectives as per judgement of the investigator.","locations":[{"facility":"Radboud University Medical Center","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Maastricht University Medical Center+","city":"Maastricht","state":"Limburg","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam University Medical Center","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Groningen","city":"Groningen","state":"Provincie Groningen","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Leiden University Medical Center","city":"Leiden","state":"South Holland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre for Human Drug Research","city":"Leiden","state":"South Holland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Medical Center","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Utrecht","city":"Utrecht","state":"Utrecht","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Robert Rissmann, Professor","phone":"+31 71 526 9111","email":"r.rissmann@lumc.nl"},{"name":"Martijn van Doorn, MD, PhD","phone":"+31 10 704 0704","email":"m.b.a.vandoorn@erasmusmc.nl"}],"primaryOutcomes":["Lipidomics of the stratum corneum and OLINK","Cutaneous microbiome","Serum biomarkers","Plasma biomarkers","Eczema Area and Severity Index (EASI)","objective Severity Scoring of Atopic Dermatitis (oSCORAD)","Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD)","Cutaneous LE Disease Area and Severity Index Activity (CLASI-A)","Total Sum Score","The Cutaneous Lupus Activity-Investigator Global Assessment (CLA-IGA)","International Hidradenitis Suppurativa Severity Score System (IHS4)","Modified Severity-Weighted Assessment Tool (mSWAT)","Cutaneous Lymphoma Activity and Severity Index (CAILS)","Psoriasis Area and Severity Index (PASI)","Physician Global Assessment (PGA)","Body Surface Area (BSA)","Psoriasis Area and Severity Index - High Discrimination (PASI-HD)"],"hasResults":false,"conditionSlugs":["lymphoma","als","lupus","psoriasis","atopic-dermatitis","hiv"],"drugSlugs":[],"locationSlugs":["nijmegen-netherlands","maastricht-netherlands","amsterdam-netherlands","groningen-netherlands","leiden-netherlands","rotterdam-netherlands","utrecht-netherlands"],"enrichment":{"headline":"SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to comprehensively profile six immune-mediated inflammatory diseases, including atopic dermatitis (AD), plaque psoriasis (PSO), hidradenitis suppurativa (HS), cutaneous T-cell lymphoma subtype mycosis fungoides (MF), chronic spontaneous urticaria (CSU), and cutaneous lupus erythematosus (CLE) in daily practice. Data will be compared with data from healthy volunteers.","whoItsFor":["Ages 18 Years to any","Male or non-pregnant female, ≥18 years of age","Patient is willing to refrain from extensively washing (including bathing, swimming) the target lesional skin 12 hours before every study visit day","Patient is willing and able to comply with the study protocol","Female participants are willing to not get pregnant between M0 until M12, from study entry to the last study visit","The patient is willing to start the prescribed treatment","Disease-specific who can join","For patients with AD:"],"whoShouldSkip":["Have any other relevant skin infection/disease in the treatment area other than the investigated skin disease","Subjects who have received treatment with any non-marketed drug substance (that is, an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to the baseline visit","1 week for topical treatment, e.g. corticosteroids, retinoids, vitamin D analogs, calcineurin inhibitors","4 weeks for phototherapy, e.g. UVB, PUVA, PDT","4 weeks for non-biologic systemic treatment, e.g. retinoids, methotrexate, cyclosporine, JAK inhibitors","8 weeks for radiotherapy or surgery in the treatment area","8 weeks for biologics"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 840 people at 8 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.586Z"},{"nctId":"NCT07021794","title":"SARS-CoV-2 Specific Monoclonal Antibody for Post-COVID-19 Conditions (Long COVID)","officialTitle":"Effectiveness of Treating Post-COVID-19 Conditions (Long COVID) With the SARS-CoV-2 Specific Monoclonal Antibody, Sipavibart","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Nancy Klimas","sponsorClass":"OTHER","summary":"This placebo-controlled, randomized, blinded, two-arm phase II study will test the safety and potential efficacy of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.","conditions":["Post-COVID / Long-COVID"],"keywords":["LongCOVID","Monoclonal antibody (mAb) therapy","Post-viral conditions"],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"BIOLOGICAL","name":"Sipavibart"}],"enrollment":100,"startDate":"2025-07-28","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAn individual is eligible for inclusion if all of the following apply:\n\n1. 18 to 70 years old,\n2. Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting).\n3. Onset of COVID symptoms occurring on or prior to August 31st, 2023; and persistence of symptomatic expression of Long COVID (defined #6 below) for more than 3 months after COVID diagnosis.\n4. Current symptomatic expression meets the case definition of ME/CFS.\n5. PROMIS 29 score at screening of moderate to severe (≥60).\n6. Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:\n\n   1. Allowance for normal illnesses of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and acceptable ranges at the time of screening and assessment. Specifically, blood pressures \\< 150 systolic and 90 diastolic mmHg are required.\n   2. Allowance of stable comorbid conditions common in post viral illness, such as fibromyalgia, irritable bowel, interstitial cystitis, dysautonomia that have not required hospitalization in the two years prior to recruitment.\n7. Able to provide written consent to study. Agrees to participate in follow-up visits.\n\nSubject Exclusion Criteria\n\nAn individual is ineligible to participate if any of the following apply:\n\n1. Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent.\n2. Known severe anemia, defined as \\< 8 g/dL.\n3. Known stroke that resulted in cognitive impairment within 3 months of enrollment.\n4. Self-report of current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, or a history of CNS disorders that may affect cognitive function (i.e., epilepsy, stroke, brain tumor, multiple sclerosis, Parkinson's Disease, Alzheimer's disease), or substance abuse during the last two years, excluding cannabis products.\n5. Allergy to any ingredient of the study drug (self-report)\n\n   1. Sipavibart is supplied as 150 mg/mL of active ingredient in 20 mM L-histidine/L-histidine hydrochloride, 220 mM L-arginine hydrochloride, and 0.04% (w/v) polysorbate 80, at pH 6.0.\n   2. Hypersensitivity to other humanized mAbs.\n6. Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day during the last month.\n7. Active chronic infections such as HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV), indicated by self-report, and abnormal liver function tests (\\>3x upper limit of normal) or evidence in the health record of chronic active hepatitis or human immunodeficiency virus (HIV).\n8. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \\> 2.0 mg/dL or eGFR \\< 44; or currently on renal dialysis)\n9. Liver disease (self-report or laboratory results: hepatic insufficiency (bilirubin \\>2.5mg/dL or transaminases \\> 3X the upper limits of normal)\n10. Uncontrolled diabetes, evidenced by combination of morning blood glucose and previous diagnosis of diabetes, AIC\\>7\n11. Diagnosed with congestive heart failure or significant arrythmia (ventricular tachycardia with a rapid rate at rest (\\> 100 bpm), persistent atrial fibrillation, or second- or third-degree heart block)\n12. Pre-existing sustained severe hypertension (BP \\>180/110 mmHg in the sitting position)\n13. Any of the following within 4 weeks of consent (Self-reported/medical record):\n\n    1. an acute myocardial infarction or unstable angina\n    2. uncontrolled arrhythmias causing symptoms or hemodynamic compromise\n    3. acute myocarditis or pericarditis, uncontrolled acutely decompensated heart failure (acute pulmonary edema)\n    4. acute pulmonary embolism\n    5. suspected dissecting aneurysm\n    6. severe hypoxemia at rest\n    7. any acute or chronic disorder that may affect exercise performance, or\n    8. if they are aggravated by exercise (e.g., infection, thyrotoxicosis, unable to cooperate)\n14. Diagnosed bleeding disorders or use of blood-thinning medications.\n15. Current or previous receipt of any COVID antiviral medication within 30 days prior to screening (self reported)\n16. Currently have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for CFS, as described in detail in \\[13\\] which clarifies exclusionary conditions. These exclusionary diagnoses that are not otherwise listed above comprise:\n\n    1. Organ failure\n    2. Chronic inflammatory diseases\n    3. Major neurologic diseases that could cause fatigue or neurologic deficits\n    4. Diseases requiring systemic treatment (i.e., transplantation, chemotherapy, radiation)\n    5. Major endocrine diseases\n    6. Untreated primary sleep disorders\n    7. BMI \\> 40 kg/m2\n    8. Temporary conditions discovered at screening, such as\n\n       * Temporary effects of medications\n       * Temporary sleep deprivation\n       * Untreated hypothyroidism, hypothyroidism that has been inadequately controlled during the last 3 months, or free T4 level not within normal limits\n       * Active infection (for COVID-19 infection and other infections, participants may be rescreened six weeks after resolution of infection)\n17. Known diagnosis of chronic Lyme disease with persistent symptoms, sequelae, or related therapy.\n18. Any marijuana illicit drug use within 30 days of informed consent\n19. Inability to discontinue symptomatic medications for the identified time periods\n20. Moderate or severe immunocompromised patients, such as those described in the NIH COVID-Treatment Guidelines\n21. Are scheduled for a surgery during the period of study participation, had minor surgery within three months prior to screening, or had major surgery within 6 months prior to screening\n22. Participating in any interventional (including social-behavioral therapy) clinical trial of an investigational therapy within 6 weeks prior to consent, or planning to participate in another interventional clinical trial of an investigational therapy during the course of this study\n23. COVID Vaccination within 90 days prior to entry and for the duration of the study\n24. Pregnancy is excluded. Women of childbearing age will be given a pregnancy test.","locations":[{"facility":"Nova Southeastern University","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nancy Klimas, MD","phone":"954-262-2286","email":"nklimas@nova.edu"},{"name":"Alejandro Montealegre, MSN, ARNP","phone":"954-262-2286","email":"am3841@nova.edu"}],"primaryOutcomes":["Patient-Reported Outcomes Measurement Information System-29","Review of Treatment Related Adverse Events"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["fort-lauderdale-florida"],"enrichment":{"headline":"Phase 2: testing Placebo for Post-COVID / Long-COVID","inPlainEnglish":"This compared with a dummy treatment, randomly assigned, blinded, two-arm phase II study will test the safety and potential how well it works of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.","whoItsFor":["Ages 18 Years to 70 Years","An individual is eligible for inclusion if all of the following apply:","18 to 70 years old,","Inciting event: Acute COVID documented by testing (PCR or antigen testing in a clinical setting)","Onset of COVID symptoms occurring on or prior to August 31st, 2023; and persistence of symptomatic expression of Long COVID (defined #6 below) for more than 3 months after COVID diagnosis","Current symptomatic expression meets the case definition of ME/CFS","PROMIS 29 score at screening of moderate to severe (≥60)","Meets National Academy of Sciences (NAS) criteria for Long COVID with the following provisions:"],"whoShouldSkip":["An individual is ineligible to participate if any of the following apply:","Known active acute SARS-CoV-2 infection ≤ 4 weeks from consent","Known severe anemia, defined as \\< 8 g/dL","Known stroke that resulted in cognitive impairment within 3 months of enrollment","Allergy to any ingredient of the study drug (self-report)","Sipavibart is supplied as 150 mg/mL of active ingredient in 20 mM L-histidine/L-histidine hydrochloride, 220 mM L-arginine hydrochloride, and 0.04% (w/v) polysorbate 80, at pH 6.0","Hypersensitivity to other humanized mAbs"],"whatHappens":"If you join, the listed intervention(s) are Placebo, or Sipavibart. The registry lists allocation as randomized. This compared with a dummy treatment, randomly assigned, blinded, two-arm phase II study will test the safety and potential how well it works of the targeted mAb, Sipavibart (formerly AZD3152) in patients with Long COVID.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at Fort Lauderdale. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.237Z"},{"nctId":"NCT07022015","title":"Predictive Risk Factors for Pancreatic Fistula After Pancreaticoduodenectomy","officialTitle":"Predictive Risk Factors for Postoperative Pancreatic Fistula After Pancreaticoduodenectomy for Malignancy.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Minia University","sponsorClass":"OTHER","summary":"Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD. In this study, the investigators aim to determine the predictive risk factors for clinically related postoperative pancreatic fistula (CR-POPF) in the preoperative, intraoperative and postoperative period in patients that underwent PD. The total number of 100 participants expected to be included in this research who underwent PD between 2025 and 2026.","conditions":["Pancreas Cancer","Pancreas Neoplasm","Pancreatic Fistula","Pancreas Adenocarcinoma","Periampullary Cancer","Periampullary Carcinoma","Resectable Pancreatic Cancer"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"pancreaticoduodenectomy procedure"}],"enrollment":100,"startDate":"2025-06-20","completionDate":"2027-03-20","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas.\n* Patients meeting the curative treatment intent in accordance with clinical guidelines:\n\n  * No evidence of metastasis.\n  * Radiological non-involvement of superior mesenteric vein \\& portal vein.\n* American Society of Anesthesiologists (ASA) scores I \\& II.\n* Patients aged \\> 18 years.\n* Ability to understand and the willingness to sign a written informed consent document\n* Agreement to complete the study\n\nExclusion Criteria:\n\n* Unfit patients for surgery due to severe medical illness.\n* Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.\n* Irresectable tumors in diagnostic laparoscopy.\n* History of other malignant disease.\n* Pregnant or breast-feeding women.\n* Patients with serious mental disorders.\n* Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data.\n* Pancreatoduodenectomy for other diagnosis like cystic lesions, benign tumors or chronic calcific pancreatitis\n* Patients refused to participate in the study.","locations":[{"facility":"Liver and GIT hospital , Minia University","city":"Minya","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Saleh K Saleh, MD","phone":"01201765401","email":"salehkhairy@mu.edu.eg"}],"primaryOutcomes":["Incidence of clinically relevant post operative pancreatic fistula"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["minya-egypt"],"enrichment":{"headline":"Not a traditional drug phase: pancreaticoduodenectomy procedure for Pancreas Cancer","inPlainEnglish":"Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality. Postoperative pancreatic fistula (POPF) is the most common and clinically significant complication following PD.","whoItsFor":["Ages 18 Years to 75 Years","Patients with resectable distal common bile duct carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas","Patients meeting the curative treatment intent in accordance with clinical guidelines:","No evidence of metastasis","Radiological non-involvement of superior mesenteric vein \\& portal vein","American Society of Anesthesiologists (ASA) scores I \\& II","Patients aged \\> 18 years","Agreement to complete the study"],"whoShouldSkip":["Unfit patients for surgery due to severe medical illness","Inoperable patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs","Irresectable tumors in diagnostic laparoscopy","History of other malignant disease","Pregnant or breast-feeding women","Patients with serious mental disorders","Patients with vascular invasion and requiring vascular resection as evaluated by the multidisciplinary team according to abdominal imaging data"],"whatHappens":"If you join, the listed intervention(s) are pancreaticoduodenectomy procedure. The registry lists allocation as na. Pancreaticoduodenectomy (PD) is a complex procedure performed in patients with malignant or benign tumors of the pancreatic head and periampullary region, associated with high morbidity and mortality.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Minya. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.438Z"},{"nctId":"NCT07022483","title":"A Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer in Adjuvant Setting","officialTitle":"A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.","conditions":["Endometrial Cancer"],"keywords":["endometrial cancer","T-DXd","HER2","adjuvant treatment"],"interventions":[{"type":"DRUG","name":"Trastuzumab Deruxtecan"},{"type":"DRUG","name":"Chemotherapy"}],"enrollment":710,"startDate":"2025-09-30","completionDate":"2030-02-26","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n* Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)\n* Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed).\n* Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and/or regional spread of the tumor of any histological subtype.\n* Has HER2-expression (IHC 3+/2+).\n* Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory.\n\nKey Exclusion Criteria\n\n* Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed.\n* Has recurrent or FIGO 2023 Stage IV\n* Has residual tumor after surgery as determined by BICR assessment.\n* Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available\n* Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI.\n* Has a QTcF prolongation to \\> 480 msec based on average of the SCR triplicate12-lead ECG.\n* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy.\n* Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.","locations":[{"facility":"Broward Health Medical Center","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkview Research Center","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trials365 LLC","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minnesota Oncology Hematology, P.A.","city":"Coon Rapids","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FirstHealth of the Carolinas, Inc.","city":"Pinehurst","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Physicians Group, LLC","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western Pennsylvania Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Medical Group Gynecologic Oncology Sioux Falls","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology, P.A. - Tyler","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Bedford","city":"Bedford","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology San Antonio Medical Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires","city":"Ciudad Autonoma Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Allende Cerro","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Medicas Mar del Plata","city":"Mar del Plata","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia de Rosario","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Medico de la Fundacion Estudios Clinicos","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CER San Juan Centro Polivalente de Asistencia e Inv. 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Sw. Jana Pawla II w Siedlcach Sp z o o","city":"Siedlce","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital da Luz","city":"Lisbon","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario A Coruña","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Arrixaca","city":"El Palmar","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Son Espases","city":"Palma de Mallorca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Contact for Trial Information","phone":"908-992-6400","email":"CTRinfo_us@daiichisankyo.com"}],"primaryOutcomes":["Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["fort-lauderdale-florida","miami-florida","miami-beach-florida","orlando-florida","fort-wayne-indiana","shreveport-louisiana","coon-rapids-minnesota","pinehurst-north-carolina","cincinnati-ohio","pittsburgh-pennsylvania","sioux-falls-south-dakota","bedford-texas","san-antonio-texas","ciudad-autonoma-buenos-aires-argentina","c-rdoba-argentina","mar-del-plata-argentina","rosario-argentina","san-juan-argentina","concepci-n-chile","santiago-chile","beijing-china","changchun-china","chengdu-china","hangzhou-china","jinan-china","linyi-china","nanchang-china","nanning-china","shanghai-china","tianjin-china","wenzhou-china","wuhan-china","yantai-china","caen-france","clermont-ferrand-france","toulouse-france","detmold-germany","frankfurt-germany","marousi-greece","holon-israel","bari-italy","bologna-italy","florence-italy","lecco-italy","milan-italy","naples-italy","torino-italy","akashi-shi-japan","ch-ku-japan","fukuoka-japan","fukushima-japan","hidaka-shi-japan","k-toku-japan","kurume-shi-japan","niigata-japan","okayama-japan","ota-shi-japan","sapporo-japan","sendai-japan","shinjuku-ku-japan","tsu-japan","yamagata-japan","bialystok-poland","gdynia-poland","poznan-poland","siedlce-poland","lisbon-portugal","daegu-south-korea","seoul-south-korea","a-coru-a-spain","el-palmar-spain","madrid-spain","palma-de-mallorca-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 3: testing Trastuzumab Deruxtecan for Endometrial Cancer","inPlainEnglish":"This study is designed to assess how well it works and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.","whoItsFor":["Ages 18 Years to any","Women only","Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)","Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed)","Has HER2-expression (IHC 3+/2+)","Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory"],"whoShouldSkip":["Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed","Has recurrent or FIGO 2023 Stage IV","Has residual tumor after surgery as determined by BICR assessment","Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available","Has a QTcF prolongation to \\> 480 msec based on average of the SCR triplicate12-lead ECG","Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab Deruxtecan, or Chemotherapy. The registry lists allocation as randomized. This study is designed to assess how well it works and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 710 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.347Z"},{"nctId":"NCT07028489","title":"Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer","officialTitle":"Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"N-Power Medicine","sponsorClass":"INDUSTRY","summary":"The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (\\~30%) will undergo imaging with standardized intervals.","conditions":["Non Small Cell Lung Cancer"],"keywords":["metastatic","advanced"],"interventions":[],"enrollment":130,"startDate":"2025-06-05","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA\n\n* Be ≥18 years of age at the time of informed consent\n* Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.\n\nEXCLUSION CRITERIA\n\n* ECOG≥2 at diagnosis of advanced or metastatic NSCLC\n* Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.","locations":[{"facility":"Pacific Cancer Care","city":"Monterey","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Torrance Memorial Physician Network-Cancer Care","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Muir Health","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bayhealth Cancer Center- Kent","city":"Dover","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bayhealth Cancer Center- Sussex","city":"Milford","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology & Hematology","city":"Elk Grove Village","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Mexico Oncology Hematology Consultants","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lankenau Medical Center","city":"Paoli","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants, P.A.","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"N-Power Medicine Support","phone":"1-833-467-6734","email":"support@npowermedicine.com"}],"primaryOutcomes":["Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["osimertinib"],"locationSlugs":["monterey-california","torrance-california","walnut-creek-california","dover-delaware","milford-delaware","coeur-dalene-idaho","elk-grove-village-illinois","albuquerque-new-mexico","paoli-pennsylvania","houston-texas"],"enrichment":{"headline":"Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non…","inPlainEnglish":"The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy.","whoItsFor":["Ages 18 Years to any","Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later"],"whoShouldSkip":["ECOG≥2 at diagnosis of advanced or metastatic NSCLC","Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 130 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.686Z"},{"nctId":"NCT07038356","title":"Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure","officialTitle":"Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Christian Schulze","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization.\n\nRandomized treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching placebo during the in-hospital stay (up to a maximum of 30 days), followed by treatment with empagliflozin 10 mg daily after discharge (but no later than day 31) until day 90.\n\nThe primary outcome measure is the combined hierarchical endpoint of all-cause mortality, heart failure hospitalization and worsening renal function at 90 days after admission.\n\nSecondary outcome measures are the effects on urine output, diuretic efficiency, quality-of-life and the need for further administration of diuretics.\n\nParticipants will\n\n* Take one tablet of study medication once daily (day 1 to day 90)\n* Restrict fluid intake to 1.5 liters of fluid per day and record the daily fluid intake for the study from day 1 to day 6 in the patient diary\n* Measure the urine output (day 1 to day 6)\n* Fill in Questionnaires (EQ-5D-3L (3-level version of the EuroQol five dimensional descriptive system), KCCQ-12 (Kansas City Cardiomyopathy Questionnaire comprising 12 items)) on day 0 (Baseline), at hospital discharge, and on day 30","conditions":["Acute Decompensated Heart Failure (ADHF)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG Oral Tablet [Jardiance]"},{"type":"DRUG","name":"Placebo"}],"enrollment":536,"startDate":"2025-12-08","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor\n* Brain Natriuretic Peptide (BNP) \\>100 pg/ml or N-terminal pro-BNP (NTproBNP) \\>300 pg/ml\n* Written informed consent obtained\n* Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus\n* Chronic Kidney Disease (CKD) with eGFR\\<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment\n* Acute kidney injury (AKI) requiring dialysis treatment\n* Known intolerance to empagliflozin\n* Acute heart failure without signs of congestion (\"dry\" patient)\n* Need for hemofiltration or any other form of extracorporeal therapy\n* Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)\n* Identification of any causes of heart failure leading to decompensation that needs urgent management (like acute coronary syndrome, severe unstable arrhythmias, mechanical causes, acute pulmonary embolism)\n* Incapacity to understand and / or to provide written informed consent\n* Obvious uncontrolled substance abuse\n* Pregnancy, breastfeeding","locations":[{"facility":"Jena University Hospital","city":"Jena","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kerckhoff-Klinik GmbH","city":"Bad Nauheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deutsches Herzzentrum der Charité, Klinik für Kardiologie, Angiologie und Intensivmedizin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II, Herzzentrum","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herzzentrum Dresden GmbH Universitaetsklinik","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsmedizin Goettingen","city":"Göttingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III","city":"Halle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Leipzig AöR","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herzzentrum Leipzig GmbH","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR","city":"Mainz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"LMU Klinikum Muenchen AöR","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rostock University Medical Center","city":"Rostock","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Four-step hierarchical composite primary endpoint; win ratio based on the following parameters (day 90): time to all-cause death, number of heart failure events per patient, time to first heart failure event, eGFR decrease from baseline to day 90"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":["empagliflozin"],"locationSlugs":["jena-germany","bad-nauheim-germany","berlin-germany","bonn-germany","dresden-germany","g-ttingen-germany","halle-germany","leipzig-germany","mainz-germany","m-nchen-germany","rostock-germany"],"enrichment":{"headline":"Phase 3: testing Empagliflozin 10 MG Oral Tablet [Jardiance] for Acute Decompensated Heart Failure (ADHF)","inPlainEnglish":"The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization. randomly assigned treatment (plus standard medical care) in patients with acute decompensated heart failure is one (1) tablet daily of empagliflozin 10 mg or matching dummy treatment (placebo) during the in-hospital stay (up to a maximum of 30 days), followed by treatment with empagliflozin 10 mg daily after discharge (but no later than day 31) until day 90.","whoItsFor":["Ages 18 Years to any","Patients (age ≥ 18 years) with acute decompensated heart failure (HF) according to clinical assessment on active therapy with a SGLT2 inhibitor","Brain Natriuretic Peptide (BNP) \\>100 pg/ml or N-terminal pro-BNP (NTproBNP) \\>300 pg/ml","Women of childbearing potential: negative pregnancy test and use of a highly effective method of contraception"],"whoShouldSkip":["Type 1 diabetes mellitus","Chronic Kidney Disease (CKD) with eGFR\\<20 ml/min, or end-stage renal failure with the need for chronic dialysis treatment","Acute kidney injury (AKI) requiring dialysis treatment","Known intolerance to empagliflozin","Acute heart failure without signs of congestion (\"dry\" patient)","Need for hemofiltration or any other form of extracorporeal therapy","Previous participation in this trial or recent participation in another clinical trial (within the last 4 weeks before inclusion)"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG Oral Tablet [Jardiance], or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to test the hypothesis that the continuation of empagliflozin during decongestive therapy in the setting of acute decompensated and hospitalized heart failure patients is not inferior compared to therapy cessation during the acute heart failure hospitalization.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 536 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.606Z"},{"nctId":"NCT07039110","title":"Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis","officialTitle":"The Real-World Impact of Risankizumab on the Quality of Life and Cumulative Life Course Impairment (CLCI) in Patients With Moderate-to-Severe Plaque Psoriasis (DREAM)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.","conditions":["Plaque Psoriasis"],"keywords":["Plaque Psoriasis","Moderate to Severe Plaque Psoriasis","Risankizumab"],"interventions":[],"enrollment":700,"startDate":"2025-09-09","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.\n* Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines.\n* Decision to treat with risankizumab is made prior to and independently of study participation.\n\nExclusion Criteria:\n\n* History of a sleep disorder diagnosis which the patient is currently being treated for.\n* Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.\n* Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.","locations":[{"facility":"Dermatology Research Institute - Blackfoot Trail /ID# 276722","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rejuvenation Dermatology - Edmonton Downtown /ID# 276688","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winnipeg Clinic /ID# 276751","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wiseman Dermatology Research /ID# 276847","city":"Winnipeg","state":"Manitoba","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cca Medical Research /ID# 276944","city":"Ajax","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quinte dermatology /ID# 277497","city":"Belleville","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatrials Research /ID# 276714","city":"Hamilton","state":"Ontario","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Lovegrove Dermatology /ID# 276797","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lynderm Research Inc /ID# 276755","city":"Markham","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rejuvenation Dermatology Clinic Oakville /ID# 277492","city":"Oakville","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"JRB Research inc. /ID# 277730","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Factor Dermatology /ID# 278610","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"SKiN Centre for Dermatology /ID# 277594","city":"Peterborough","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eternal Springtime Dermatology /ID# 278598","city":"Thunder Bay","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"North York Research /ID# 276835","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avenue Research Group /ID# 276846","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre for Medical and Surgical Dermatology /ID# 278775","city":"Whitby","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dre Angelique Gagne-Henley M.D. inc. /ID# 276687","city":"Saint-Jérôme","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni Nemocnice U Sv. 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Moritz Huber und Dr. med. Martin Heister /ID# 277627","city":"Friedrichshafen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermakulm /Id# 277864","city":"Kulmbach","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermazent /Id# 280327","city":"Munich","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hautaerzte am Nauener Tor /ID# 284579","city":"Potsdam","state":"Brandenburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Dortmund Klinikzentrum Mitte /ID# 284856","city":"Dortmund","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsmedizin Mainz /ID# 278229","city":"Mainz","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatologie Moelln Praxis Dr. Bodo Segert /ID# 277628","city":"Mölln","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Hamburg-Eppendorf /ID# 277164","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cutaneum /ID# 277294","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Mario Pawlak /ID# 277465","city":"Heilbad Heiligenstadt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hautarztpraxis Dr. Med. Ulrike Wiemers / Dr. Med. Franca Wiemers /ID# 277821","city":"Leipzig","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Hautarztpraxis Schwelm /ID# 277464","city":"Schwelm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital Andreas Syggros /ID# 276826","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital Andreas Syggros /ID# 279246","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital Attikon /ID# 278389","city":"Chaïdári","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tzaneio Prefecture General Hospital of Piraeus /ID# 276532","city":"Piraeus","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asklipieio General Hospital of Voula /ID# 278235","city":"Voula","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University Hospital of Larissa /ID# 276576","city":"Larissa","state":"Thessaly","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276488","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of Skin and Venereal Diseases- Thessaloniki /ID# 276489","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Papageorgiou General Hospital /ID# 276487","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASL 1 Abruzzo - Ospedale regionale San Salvatore /ID# 277341","city":"L’Aquila","state":"L Aquila","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele /ID# 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278260","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosui General Medical Clinic /ID# 279520","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kagoshima University Hospital /ID# 278514","city":"Kagoshima","state":"Kagoshima-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokai University Hospital /ID# 278294","city":"Isehara","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama City University Hospital /ID# 278257","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Kyoto Prefectural University of Medicine /ID# 278962","city":"Kyoto","state":"Kyoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kawasaki Medical School Hospital /ID# 278259","city":"Kurashiki","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of the Ryukyus Hospital /ID# 278256","city":"Ginowan-shi","state":"Okinawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kindai University Hospital /ID# 278258","city":"Sakai-shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital /ID# 278436","city":"Suita-shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jichi Medical University Hospital /ID# 280236","city":"Shimotsuke-shi","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital /ID# 278495","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seibo Hospital /ID# 279522","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka University Hospital /ID# 278600","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nippon Life Saiseikai Public Interest Foundation Nippon Life Hospital /ID# 278434","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Yamate Medical Center /ID# 278960","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teikyo University Hospital /ID# 278228","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nihon University Itabashi Hospital /ID# 279916","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Malaga /ID# 277220","city":"Málaga","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Leon /ID# 277895","city":"León","state":"Leon","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Santa Maria Del Rosell /ID# 277894","city":"Cartagena","state":"Murcia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario Virgen de la Arrixaca /ID# 283338","city":"El Palmar","state":"Murcia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Morales Meseguer /ID# 283339","city":"Murcia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Pontevedra /ID# 278085","city":"Pontevedra","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario De Toledo /ID# 277896","city":"Toledo","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julieta Gonzalez Blanco","phone":"844-663-3742","email":"julieta.gonzalezblanco@abbvie.com"}],"primaryOutcomes":["Proportion of participants achieving a Dermatology Life Quality Index (DLQI) score of 0 or 1"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":["risankizumab"],"locationSlugs":["calgary-canada","edmonton-canada","winnipeg-canada","ajax-canada","belleville-canada","hamilton-canada","london-canada","markham-canada","oakville-canada","ottawa-canada","peterborough-canada","thunder-bay-canada","toronto-canada","whitby-canada","saint-j-r-me-canada","brno-czechia","prague-czechia","pilsen-czechia","esk-bud-jovice-czechia","dijon-france","niort-france","romans-sur-is-re-france","beauvais-france","le-mans-france","toulon-france","boulogne-billancourt-france","friedrichshafen-germany","kulmbach-germany","munich-germany","potsdam-germany","dortmund-germany","mainz-germany","m-lln-germany","hamburg-germany","heilbad-heiligenstadt-germany","leipzig-germany","schwelm-germany","athens-greece","cha-d-ri-greece","piraeus-greece","voula-greece","larissa-greece","thessaloniki-greece","laquila-italy","milan-italy","naples-italy","rome-italy","genova-italy","maebashi-japan","asahikawa-shi-japan","sapporo-japan","kagoshima-japan","isehara-japan","yokohama-japan","kyoto-japan","kurashiki-japan","ginowan-shi-japan","sakai-shi-japan","suita-shi-japan","shimotsuke-shi-japan","bunkyo-ku-japan","shinjuku-ku-japan","fukuoka-japan","osaka-japan","tokyo-japan","m-laga-spain","le-n-spain","cartagena-spain","el-palmar-spain","murcia-spain","pontevedra-spain","toledo-spain"],"enrichment":{"headline":"Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-…","inPlainEnglish":"Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.","whoItsFor":["Ages 18 Years to any","Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment","Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing/treatment guidelines","Decision to treat with risankizumab is made prior to and independently of study participation"],"whoShouldSkip":["History of a sleep disorder diagnosis which the patient is currently being treated for","Current or recent (within the last 30 days) participation in an treatment clinical trial or an watch-and-measure (no experimental treatment required) study","Currently receiving other biologic treatments and/or small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 700 people at 84 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.575Z"},{"nctId":"NCT07043543","title":"Evaluation of the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer (BLADAPT-GETUG V11)","officialTitle":"Randomized Open Phase II Multienter Study Evaluating the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Institut du Cancer de Montpellier - Val d'Aurelle","sponsorClass":"OTHER","summary":"Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery. One of the main challenges of TMT is the planning and delivery of radiation therapy. Indeed, the bladder is a mobile hollow organ subject to repletion, with variations in size and shape during and between radiotherapy sessions. Standard radiotherapy techniques require large planning target volume margins around the bladder, which can be responsible for irradiation of a large volume of large and small bowel with grade 2 and 3 toxicities.\n\nAdaptive radiotherapy allows for the generation of a treatment fraction personalized to a patient's anatomical modification with margin reduction and improves the dosimetric quality of the delivered plans.\n\nThe hypothesis is that this improvement results in radiation-induced toxicity improvement.","conditions":["Bladder Cancer"],"keywords":["Adaptive radiotherapy","standard radiotherapy","Tri-Modal therapy"],"interventions":[{"type":"RADIATION","name":"Adaptive radiotherapy"},{"type":"RADIATION","name":"standard radiotherapy"}],"enrollment":120,"startDate":"2026-03-04","completionDate":"2029-01-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically proven muscle-infiltrating bladder cancer (de novo MIBC or after a history of non-muscle-invasive bladder cancer) or patients with initial high-grade T1 tumor showing Ta or T1 recurrence, or those with high-grade T1 after a course of intravesical biological therapy or chemotherapy;\n* Age ≥ 18 years;\n* Urothelial carcinoma (transitional cell carcinoma of the bladder, micropapillary, microcystic with trophoblastic differenciation) and squamous cell histological types are allowed;\n* Stage T1-T4aN0M0\n* TransUrethral Resection of Bladder Tumor (TURBT) and Position Emission Tomography- scanner and X-ray Computed Tomography (PET-CT) or Computed Tomography scan of thorax/abdomen/pelvis (without carcinological anomaly) within 8 weeks prior to the start of radiation therapy (if TURBT was performed more than 6 weeks before the inclusion visit, a new TURBT or, at least, a cystoscopy showing no progression, no residual tumour or regrowth must be done);\n* Suitable for radiotherapy;\n* Eastern Cooperative Oncology Group/World Human Organisation (ECOG/WHO) performance status from 0 to 2\n* Negative pregnancy test (blood or urine), for women of childbearing age only;\n* If the patient is sexually active, he/she must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of study drug administration and 6 months after the end of treatment for both men and women.\n* Affiliation to the French Social Security System;\n* Dated, written and signed Informed consent\n\nExclusion Criteria:\n\n* Prior pelvic radiation therapy;\n* Patients with previous or concomitant other malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least five years;\n* Presence of endopenic stent;\n* Inability to comply with the protocol;\n* Grade 1 or greater baseline diarrhea;\n* Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease);\n* Uncontrolled immune or cardiac or pulmonary disease;\n* Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons;\n* Legal incapacity or physical, psychological or mental status interfering with the patient's ability to sign the informed consent or to terminate the study;\n* Pregnant or breast-feeding subjects","locations":[{"facility":"Centre Georges François Leclerc","city":"Dijon","state":"Côte D'or","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut du Cancer de Montpellier","city":"Montpellier","state":"Herault","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugène Marquis","city":"Rennes","state":"Ille Et Vilaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancérologie de l'Ouest","city":"Saint-Herblain","state":"Loire Atlantique","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret","city":"Lille","state":"Nord","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de radiothérapie Bayard","city":"Villeurbanne","state":"Rhone","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Henri Becquerel","city":"Rouen","state":"Seine Maritime","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Sainte Catherine","city":"Avignon","state":"Var","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de radiothérapie Saint-Louis","city":"Toulon","state":"Var","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Tenon","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Saint-Cloud","state":"Île-de-France Region","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aurore MOUSSION","phone":"467613102","email":"aurore.moussion@icm.unicancer.fr"}],"primaryOutcomes":["evaluation of the technique of adaptive radiotherapy in terms of acute Gastro-Intestinal toxicity."],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["dijon-france","montpellier-france","rennes-france","saint-herblain-france","lille-france","villeurbanne-france","rouen-france","avignon-france","toulon-france","paris-france","saint-cloud-france"],"enrichment":{"headline":"Not a traditional drug phase: Adaptive radiotherapy for Bladder Cancer","inPlainEnglish":"Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery. One of the main challenges of TMT is the planning and delivery of radiation therapy.","whoItsFor":["Ages 18 Years to any","Urothelial carcinoma (transitional cell carcinoma of the bladder, micropapillary, microcystic with trophoblastic differenciation) and squamous cell histological types are allowed;","Suitable for radiotherapy;","Eastern Cooperative Oncology Group/World Human Organisation (ECOG/WHO) performance status from 0 to 2","Negative pregnancy test (blood or urine), for women of childbearing age only;","If the patient is sexually active, he/she must agree to use contraception deemed adequate and appropriate by the investigator throughout the period of study drug administration and 6 months after the end of treatment for both men and women","Affiliation to the French Social Security System;"],"whoShouldSkip":["Prior pelvic radiation therapy;","Presence of endopenic stent;","Inability to comply with the protocol;","Grade 1 or greater baseline diarrhea;","Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease);","Uncontrolled immune or cardiac or pulmonary disease;","Patients whose regular follow-up is impossible for psychological, family, social or geographical reasons;"],"whatHappens":"If you join, the listed intervention(s) are Adaptive radiotherapy, or standard radiotherapy. The registry lists allocation as randomized. Trimodal therapy (TMT) consisting of transurethral resection of bladder tumors followed by radiotherapy and chemotherapy is a therapeutic alternative in patients with Muscle-Infiltrating Bladder Cancer who are inoperable or refuse surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 11 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.290Z"},{"nctId":"NCT07051707","title":"Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD","officialTitle":"A Multicenter, Randomized, Study to Evaluate Safety and Efficacy After Treatment With the dNerva Lung Denervation System in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-4)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Nuvaira, Inc.","sponsorClass":"INDUSTRY","summary":"The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.","conditions":["COPD","Chronic Obstructive Pulmonary Disease"],"keywords":["Optimal Medical Care","Device: dNerva Lung Denervation System","Device: Targeted Lung Denervation (TLD)"],"interventions":[{"type":"DEVICE","name":"Targeted Lung Denervation (TLD)"}],"enrollment":200,"startDate":"2026-02-24","completionDate":"2028-04-30","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥ 40 and ≤ 80 years of age at the time of consent.\n* Women of childbearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study.\n* Smoking history of at least 10 pack years.\n* Not smoking or using any other inhaled substance (e.g. cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study.\n* Resting SpO2 ≥ 89% on room air.\n* MMRC ≥ 2; CAT score ≥ 10.\n* Diagnosis of moderate to severe COPD as defined by FEV1/FVC \\< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \\< 50 (if FEV1 \\< 30%).\n* RV ≥ 175% of predicted and RV/TLC \\> 55% (post-bronchodilator).\n* Participant is on standard medical care, defined as a minimum of therapy with LABA/ICS, LAMA/LABA, or LAMA/LABA/ICS for at least 2 months prior to consent.\n* If subject has participated in a formal pulmonary rehabilitation program recently, program completion must have occurred ≥3 months prior to consent; if in a maintenance program, subject agrees to continue their current program through their 12-month follow-up visit; NOTE: Prior participation in a pulmonary rehabilitation program is not required for inclusion in the study.\n* Participant is a candidate for bronchoscopy in the opinion of the investigator or per hospital guidelines and is able to discontinue blood thinning medication peri-procedurally.\n* Participant is able and agrees to complete all protocol required baseline and follow up tests and assessments including taking certain medications (e.g., azithromycin, prednisolone/prednisone).\n\nExclusion Criteria:\n\n* Body Mass Index (BMI) \\<18 or \\>32.\n* Participant has an implantable electronic device and has not received appropriate medical clearance.\n* Uncontrolled diabetes in the opinion of the investigator.\n* 4 or more respiratory related hospitalizations within 1 year of consent.\n* Malignancy treated with radiation or chemotherapy within 1 year of consent.\n* Participant diagnosed with a dominant non-COPD lung disease, or condition affecting the lungs, which is the main driver of the participant's clinical symptoms (e.g., cystic fibrosis, paradoxical vocal cord motion, eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillosis, interstitial lung disease or active tuberculosis or Asthma) or has a documented medical history of pneumothorax within 1 year of consent.\n* Clinically relevant bronchiectasis, defined as \\> 1/3 cup mucous expectoration daily.\n* Pre-existing diagnosis of pulmonary hypertension, clinical evidence of pulmonary hypertension (e.g., cardiovascular function impairment including peripheral edema) and mPAP ≥25 mmHg at rest by right heart catheterization (or estimated right ventricular systolic pressure \\>50 mmHg by echocardiogram if no previous right heart catheterization).\n* Myocardial infarction within last 6 months, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \\< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure.\n* Surgical procedure(s) on the stomach, esophagus or pancreas performed ≤2 years of consent, or ongoing related symptoms within the past year.\n* Symptomatic gastric motility disorder(s) (e.g., gastroparesis) as evidenced by GCSI score ≥18.0, severe uncontrolled GERD (e.g., refractory heartburn, endoscopic esophagitis) or severe dysphagia (e.g., esophageal stricture, achalasia, esophageal spasm). NOTE: Participants with a hiatal hernia are allowed if Participant meets all other enrollment criteria.\n* Any disease or condition that might interfere with completion of a procedure or this study (e.g., structural esophageal disorder, life expectancy \\<3 years).\n* Prior lung or chest procedure (e.g., BLVR explant procedure, median sternotomy, bullectomy, lobectomy, segmentectomy or other interventional lung or chest procedure) performed ≤1 year of consent? Participants with lung transplant, BLVR valves, LVRS, metal stents within 5cm of the anticipated treatment location; presence of lung volume reduction valves, coils or other lung implants.\n* Daily use of \\>20 mg of prednisone or its equivalent at the time of consent.\n* Known contraindication or allergy to medications required for bronchoscopy or general anesthesia (e.g., lidocaine, atropine, propofol, sevoflurane) that cannot be medically controlled.\n* Baseline chest CT scan reveals bronchial anatomy cannot be treated with available catheter sizes; presence of whole lung emphysema \\>20% (-950 HU), single lung emphysema \\>26% (-950 HU), severe bullous disease (\\>1/3 hemithorax) or discovery of a mass that requires treatment.\n* Participant is currently enrolled in another drug or interventional clinical trial that has not completed follow-up.","locations":[{"facility":"University of Alabama-Birmingham Hospital - UAB Lung Health Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital - Lung and Pulmonary Care","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest School of Medicine","city":"Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Medical Center - Ohio State Lung Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Highlands - Lung Innovations/Clinical Research Associates","city":"DuBois","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University - Temple Lung Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center - UMPC Comprehensive Lung Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University Health System","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elyse Ebeling","phone":"763-450-2803","email":"eebeling@nuvaira.com"},{"name":"Angie McFadden","phone":"763-450-2825","email":"amcfadden@nuvaira.com"}],"primaryOutcomes":["The primary endpoint is improvement in FEV1 at 6 months."],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","jacksonville-florida","detroit-michigan","salem-north-carolina","columbus-ohio","dubois-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","richmond-virginia","milwaukee-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Targeted Lung Denervation (TLD) for COPD","inPlainEnglish":"The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. this study wants to confirm the safety and how well it works of the Nuvaira Lung Denervation System in the treatment of COPD.","whoItsFor":["Ages 40 Years to 80 Years","≥ 40 and ≤ 80 years of age at the time of consent","Women of childbearing potential must not be pregnant, evidenced by a negative pregnancy test (blood or urine) pre-treatment, or lactating and agree not to become pregnant for the duration of the study","Smoking history of at least 10 pack years","Not smoking or using any other inhaled substance (e.g. cigarettes, vaping, cannabis, pipes) for a minimum of 2 months prior to consent and agrees to not start for the duration of the study","Resting SpO2 ≥ 89% on room air","MMRC ≥ 2; CAT score ≥ 10","Diagnosis of moderate to severe COPD as defined by FEV1/FVC \\< 70% (post-bronchodilator), 25% ≤ FEV1 ≤ 70% predicted, and PaCO2 \\< 50 (if FEV1 \\< 30%)"],"whoShouldSkip":["Body Mass Index (body-mass index (BMI)) \\<18 or \\>32","Participant has an implantable electronic device and has not received appropriate medical clearance","Uncontrolled diabetes in the opinion of the investigator","4 or more respiratory related hospitalizations within 1 year of consent","Malignancy treated with radiation or chemotherapy within 1 year of consent","Clinically relevant bronchiectasis, defined as \\> 1/3 cup mucous expectoration daily","Myocardial infarction within last 6 months, evidence of life-threatening arrhythmias or acute ischemia, pre-existing documented evidence of a LVEF \\< 40%, stage C or D (ACC/AHA) or Class III or IV (NYHA) congestive heart failure"],"whatHappens":"If you join, the listed intervention(s) are Targeted Lung Denervation (TLD). The registry lists allocation as randomized. The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at 10 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.656Z"},{"nctId":"NCT07053423","title":"A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.","officialTitle":"A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Dupilumab on Airway Inflammation Through Assessments of Mucus Plugging and Other Lung Imaging Parameters in Patients With Chronic Obstructive Pulmonary Disease.","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"LPS18583 is a multinational, randomized, double-blind, placebo-controlled, parallel-group, Phase 4 study with 2 treatment groups. The purpose of this study is to assess the effect of dupilumab compared with placebo on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).\n\nStudy details include:\n\nThe study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The number of visits will be 9.","conditions":["Chronic Obstructive Pulmonary Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":218,"startDate":"2025-09-22","completionDate":"2028-12-23","sex":"ALL","minAge":"40 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening:\n\n* Current or former smokers with a smoking history of ≥10 pack-years\n* Moderate-to-severe COPD (post-BD FEV1/FVC ratio \\<0.70 and post-BD FEV1 % predicted \\>30% and ≤70%)\n* Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10\n* Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations\n* Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated\n* Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation).\n* Mucus score cutoff of ≥3\n\nExclusion Criteria:\n\n* A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma\n* Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts\n* Treatment with oxygen \\>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period\n* Diagnosis of α-1 anti-trypsin deficiency\n* Any biologic therapy (including experimental treatments and dupilumab)\n* Participants on treatment with mucolytics unless on stable therapy for \\>6 months\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"University of Alabama at Birmingham - School of Medicine- Site Number : 8400003","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Dermatology Clinical Trials Unit- Site Number : 8400015","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Finlay Medical Research- Site Number : 8400010","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. David Kavtaradze- Site Number : 8400017","city":"Cordele","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center- Site Number : 8400005","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Bayview Medical Center- Site Number : 8400009","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham & Women's Hospital- Site Number : 8400014","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Health Research - Charlotte- Site Number : 8400013","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Wake Forest Baptist Pulmonary, Sleep And Allergy- Site Number : 8400004","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Associates of Central Pennsylvania- Site Number : 8400002","city":"DuBois","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"REX Clinical Trials - Beaumont- Site Number : 8400011","city":"Beaumont","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320001","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320002","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0320003","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0400005","city":"Linz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Dom Pedro De Alcantara- Site Number : 0760009","city":"Feira de Santana","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associacao Proar- Site Number : 0760005","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica CLARE- Site Number : 0760004","city":"Goiânia","state":"Goiás","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760002","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Beneficência Portuguesa de São Paulo- Site Number : 0760006","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Incor - Instituto do Coracao- Site Number : 0760001","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240005","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240002","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560005","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560013","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 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: 2500008","city":"La Tronche","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500001","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500005","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500006","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500002","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500003","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500004","city":"Reims","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational 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1580001","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1580002","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260002","city":"Dundee","state":"Dundee City","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260006","city":"Newcastle upon Tyne","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260008","city":"Southampton","state":"Hampshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260003","city":"Leicester","state":"Leicestershire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260001","city":"Bradford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260009","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":["dupilumab"],"locationSlugs":["birmingham-alabama","miami-florida","cordele-georgia","kansas-city-kansas","baltimore-maryland","boston-massachusetts","charlotte-north-carolina","winston-salem-north-carolina","dubois-pennsylvania","beaumont-texas","san-miguel-de-tucum-n-argentina","buenos-aires-argentina","linz-austria","feira-de-santana-brazil","salvador-brazil","goi-nia-brazil","porto-alegre-brazil","s-o-paulo-brazil","calgary-canada","london-canada","chengdu-china","guangzhou-china","hangzhou-china","harbin-china","ningbo-china","xiamen-china","aalborg-denmark","vejle-denmark","la-tronche-france","lille-france","lyon-france","marseille-france","montpellier-france","pessac-france","reims-france","berlin-germany","mainz-germany","debrecen-hungary","hajd-n-n-s-hungary","p-cs-hungary","cona-italy","giugliano-in-campania-italy","orbassano-italy","siena-italy","ube-japan","kyoto-japan","osaka-japan","groningen-netherlands","hoofddorp-netherlands","nijmegen-netherlands","rotterdam-netherlands","poznan-poland","bialystok-poland","ostrowiec-wi-tokrzyski-poland","riyadh-saudi-arabia","singapore-singapore","anyang-si-south-korea","seoul-south-korea","santander-spain","barcelona-spain","pozuelo-de-alarc-n-spain","oviedo-spain","madrid-spain","gothenburg-sweden","lund-sweden","basel-switzerland","geneva-switzerland","sion-switzerland","kaohsiung-city-taiwan","taipei-taiwan","dundee-united-kingdom","newcastle-upon-tyne-united-kingdom","southampton-united-kingdom","leicester-united-kingdom","bradford-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 4: testing Dupilumab for Chronic Obstructive Pulmonary Disease","inPlainEnglish":"LPS18583 is a multinational, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, Phase 4 study with 2 treatment groups. this study wants to assess the effect of dupilumab compared with dummy treatment (placebo) on airway inflammation, resistance, and remodeling including mucus plugging and its association with improvement on lung function, exacerbations, and quality of life improvement in participants aged 40 years of age up to 85 years of age (inclusive).","whoItsFor":["Ages 40 Years to 85 Years","Participants with a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who meet the following criteria at screening:","Current or former smokers with a smoking history of ≥10 pack-years","Moderate-to-severe COPD (post-BD FEV1/FVC ratio \\<0.70 and post-BD FEV1 % predicted \\>30% and ≤70%)","Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10","Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E , Frequent or severe exacerbations","Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated","Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation)"],"whoShouldSkip":["A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma","Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts","Treatment with oxygen \\>4.0 L/min for ≥8 hours/day Respiratory tract infection within 4 weeks before screening, or during the screening period","Diagnosis of α-1 anti-trypsin deficiency","Any biologic therapy (including experimental treatments and dupilumab)","Participants on treatment with mucolytics unless on stable therapy for \\>6 months","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Placebo. The registry lists allocation as randomized. LPS18583 is a multinational, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group, Phase 4 study with 2 treatment groups.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 218 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.704Z"},{"nctId":"NCT07053800","title":"Obe-cel in Severe, Refractory Systemic Lupus Erythematosus (SLE) With Active Lupus Nephritis (LN)","officialTitle":"A Single-Arm, Open-Label, Phase II Study to Determine the Safety and Efficacy of Obecabtagene Autoleucel (Obe-cel) in Participants With Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Autolus Limited","sponsorClass":"INDUSTRY","summary":"The purpose of this trial is to evaluate the efficacy and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).","conditions":["Lupus Nephritis"],"keywords":["Systemic lupus erythematosus","Refractory systemic lupus erythematosus","Lupus nephritis","Obecabtagene autoleucel","Obe-cel"],"interventions":[{"type":"BIOLOGICAL","name":"Obecabtagene autoleucel"}],"enrollment":35,"startDate":"2026-01-16","completionDate":"2028-08","sex":"ALL","minAge":"12 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative\n* Ability and willingness to adhere to protocol's Schedule of Activities and other requirements\n* Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent.\n* Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding\n* Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus.\n* Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith.\n* Severe, Active SLE defined as:\n\n  * SLEDAI-2K score of ≥ 8 points AND\n  * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)\n* Refractory SLE defined as failure to previous lines of therapy\n\nExclusion Criteria:\n\n* Prior treatment at any time with anti-CD19 therapy\n* More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible\n* Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant\n* History of primary antiphospholipid antibody syndrome\n* Active or uncontrolled fungal, bacterial, or viral infection\n* History of malignant neoplasms unless disease free for at least 24 months\n* History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"State University of New York Upstate Medical Center (SUNY)","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Children's Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Transplant Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital ATTIKON","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital of Patras","city":"Pátrai","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bristol Haematology and Oncology Centre","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western General Hospital Edinburgh","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth University Hospital","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manchester Royal Infirmary","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vinmec Hospital","city":"Hà Nội","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Autolus Ltd","phone":"+44 (0)203 911 4385","email":"clinicaltrials@autolus.com"}],"primaryOutcomes":["Proportion of participants who achieve complete renal response (CRR)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["new-york-new-york","syracuse-new-york","houston-texas","san-antonio-texas","salvador-brazil","athens-greece","p-trai-greece","birmingham-united-kingdom","bristol-united-kingdom","cambridge-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","london-united-kingdom","manchester-united-kingdom","h-n-i-vietnam"],"enrichment":{"headline":"Phase 2: testing Obecabtagene autoleucel for Lupus Nephritis","inPlainEnglish":"The purpose of this trial is to measure the how well it works and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).","whoItsFor":["Ages 12 Years to 65 Years","Ability and willingness to adhere to protocol's Schedule of Activities and other requirements","Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding","Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus","Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith","Severe, Active SLE defined as:","SLEDAI-2K score of ≥ 8 points AND","Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV)"],"whoShouldSkip":["Prior treatment at any time with anti-CD19 therapy","More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible","Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant","History of primary antiphospholipid antibody syndrome","Active or uncontrolled fungal, bacterial, or viral infection","History of malignant neoplasms unless disease free for at least 24 months","History of heart, lung, renal, liver transplant or hematopoietic stem cell transplant"],"whatHappens":"If you join, the listed intervention(s) are Obecabtagene autoleucel. The registry lists allocation as na. The purpose of this trial is to measure the how well it works and safety of obecabtagene autoleucel (obe-cel) administered once following lymphodepletion in participants with severe, refractory systemic lupus erythematosus (SLE) and active lupus nephritis (LN).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at 16 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.281Z"},{"nctId":"NCT07054866","title":"Rural Autistic Individuals - Supporting Expression","officialTitle":"Rural Autistic Individuals - Supporting Expression","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Montana State University","sponsorClass":"OTHER","summary":"This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as \\[cry\\], can promote successful understanding of words like \"cry\". The overarching goal is to help families effectively utilize gestures to support communication with their children.","conditions":["Autism Disorder","Language Development Disorders","ADHD","Typical Development","Rural Health","Children","Neuroimaging","Eye Tracking","EEG","fNIRS"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Speech-Gesture combinations"}],"enrollment":50,"startDate":"2025-10-01","completionDate":"2027-12","sex":"ALL","minAge":"2 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 1.1 Confirmed (preferably) or suspected diagnosis of ASD (autism spectrum disorder), or a receptive language impairment (i.e., difficulties with comprehension, Developmental Language Disorder), or both. Additional diagnoses, including ADHD (Attention Deficit and Hyperactivity Disorder), are acceptable. Siblings and cousins of these individuals are also welcome.\n\nOR 1.2 No diagnoses of ASD or DLD for unrelated control typically-developing participants.\n\n2\\. Normal hearing and normal vision (or corrected to normal with glasses or contacts).\n\n3\\. Ages 2+. 4. English as the dominant language of caregivers. 5. Caregivers who self-identify as living in a rural area. 6. The ability to verbally or physically respond is optional.\n\nExclusion Criteria:\n\n* 1\\. Poor hearing. 2. Inborn or acquired brain damage.","locations":[{"facility":"Montana State University","city":"Bozeman","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nadya N Modyanova, Ph.D.","phone":"406-848-1535","email":"language-research@montana.edu"},{"name":"Bernadette McCrory, Ph.D.","phone":"406-994-2801","email":"bernadette.mccrory@montana.edu"}],"primaryOutcomes":["EEG/ERP brain response"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["bozeman-montana"],"enrichment":{"headline":"Not a traditional drug phase: Speech-Gesture combinations for Autism Disorder","inPlainEnglish":"This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too.","whoItsFor":["Ages 2 Years to any","OR 1.2 No diagnoses of ASD or DLD for unrelated control typically-developing participants","2\\. Normal hearing and normal vision (or corrected to normal with glasses or contacts)","3\\. Ages 2+. 4. English as the dominant language of caregivers. 5. Caregivers who self-identify as living in a rural area. 6. The ability to verbally or physically respond is optional"],"whoShouldSkip":["1\\. Poor hearing. 2. Inborn or acquired brain damage"],"whatHappens":"If you join, the listed intervention(s) are Speech-Gesture combinations. The registry lists allocation as na. This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Bozeman. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.654Z"},{"nctId":"NCT07055282","title":"SGLT2i in Kidney Stones","officialTitle":"SGLT2i in Calcium Kidney Stones","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Chicago","sponsorClass":"OTHER","summary":"This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation. The research focuses on people who have had calcium-based kidney stones, i.e. calcium oxalate or calcium phosphate stones.\n\nPrevious studies in those without kidney stones found that empagliflozin increased urinary citrate levels without raising urine pH. The investigators are testing whether similar effects occur in people with a history of kidney stones.\n\nParticipants will take empagliflozin daily for 4 weeks. The investigators will collect 24-hour urine samples before and after treatment to measure various factors that influence stone formation, including citrate levels, pH, and calculated stone formation risk. The investigators will enroll 32 participants: 16 with a history of calcium oxalate stones and 16 with calcium phosphate stones.\n\nResults from this study may inform future larger clinical trials investigating empagliflozin as a kidney stone prevention strategy.","conditions":["Kidney Stones"],"keywords":["kidney stones","SGLT2i","empagliflozin","calcium kidney stones","kidney stone","calcium kidney stone"],"interventions":[{"type":"DRUG","name":"Empagliflozin (Jardiance®)"}],"enrollment":32,"startDate":"2025-11-20","completionDate":"2028-11-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCalcium phosphate (CaP) stone participants:\n\n* Age 18-70\n* History of at least one calcium phosphate (hydroxyapatite) stone\n\n  * Defined as at least 50% of stone material on most recent stone analysis\n\nCalcium oxalate (CaOx) stone participants:\n\n* Age 18-70\n* History of at least one calcium oxalate stone\n\n  * Defined as at least 50% of stone material on most recent stone analysis.\n\nOther inclusion criteria considerations: The investigators will study balanced numbers of male and females. Prior studies did not have balanced representation of male and female sexes. In prior studies, less than 40% were female, or sex data is not presented. Study of both male and female sex is crucial with kidney stones and therapies that affect citrate and pH because there are well established epidemiologic differences in stone type and physiologic differences in acid-base handling by sex. Epidemiologically, younger women are more likely to have CaP stones, and this is likely because they have higher urine pH.\n\nExclusion Criteria:\n\n* History of primarily brushite, uric acid, cysteine, or struvite stones\n* History of severe acid-base abnormality, very low (less than 100mg/day) or very high (greater than 1500mg/day) urine citrate\n* Participants who cannot stop diuretic medication or alkali supplementation for the course of the study period\n* Use of drugs that can directly affect proximal tubule function (e.g., topiramate)\n* Diagnosis of complete distal renal tubular acidosis\n* Diagnosis of chronic kidney disease (eGFR \\<60 mL/min/1.73m²)","locations":[{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in calcium phosphate","Change in urine citrate","Change in pH","Calcium oxalate supersaturation"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["empagliflozin"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Early phase 1: testing Empagliflozin (Jardiance®) for Kidney Stones","inPlainEnglish":"This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation. The research focuses on people who have had calcium-based kidney stones, i.e.","whoItsFor":["Ages 18 Years to 70 Years","Calcium phosphate (CaP) stone participants:","History of at least one calcium phosphate (hydroxyapatite) stone","Defined as at least 50% of stone material on most recent stone analysis","Calcium oxalate (CaOx) stone participants:","History of at least one calcium oxalate stone","Defined as at least 50% of stone material on most recent stone analysis"],"whoShouldSkip":["History of primarily brushite, uric acid, cysteine, or struvite stones","History of severe acid-base abnormality, very low (less than 100mg/day) or very high (greater than 1500mg/day) urine citrate","Participants who cannot stop diuretic medication or alkali supplementation for the course of the study period","Use of drugs that can directly affect proximal tubule function (e.g., topiramate)","Diagnosis of complete distal renal tubular acidosis","Diagnosis of chronic kidney disease (eGFR \\<60 mL/min/1.73m²)"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin (Jardiance®). The registry lists allocation as randomized. This study is looking at whether empagliflozin, a medication typically used for diabetes and heart conditions, may affect factors that contribute to kidney stone formation.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 32 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.618Z"},{"nctId":"NCT07056894","title":"Effects of Action-Based Cognitive Remediation on Substance Misuse in Early Phase Psychosis","officialTitle":"Evaluating a Brief Virtual Cognitive Remediation Therapy Intervention for Those With Early Phase Psychosis and Substance Misuse in NS/NL: Addressing Challenges in Underserviced Areas","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Nova Scotia Health Authority","sponsorClass":"OTHER","summary":"Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in significant challenges for individuals and their families, including difficulties with thinking, relationships, and overall well-being. They also carry significant economic costs, both for health care and lost productivity. Early intervention services have been shown to improve outcomes when provided during the first few years of illness known as early phase psychosis (EPP). However, substance use, especially alcohol and cannabis, can interfere with the effectiveness of these services. Many young people with psychosis misuse these substances, which can harm brain development, worsen symptoms, reduce medication use, and lower quality of life. Despite understanding the risks, there are few effective ways to reduce substance misuse in patients with EPP.\n\nOne promising approach to reducing substance misuse in this population is cognitive remediation therapy, which helps improve thinking skills and everyday functioning. Studies have found that some cognitive remediation therapies can help reduce alcohol use in chronic schizophrenia, but there is limited research targeting the EPP population. Our research team at the Nova Scotia Early Psychosis Program recently completed a pilot study that indicated a therapy called Cognitive Enhancement Therapy (CET) helped participants reduce their problematic alcohol and cannabis use. However, challenges with recruitment and lower attendance rates noted towards the end of the 6-month therapy course suggests that patients with EPP would benefit more from a therapy with a shorter timeframe. Alternatively, Action-Based Cognitive Remediation (ABCR) targets the same cognitive domains believed to help reduce substance use as CET, but has a shorter, more concise schedule. ABCR cover 16 sessions delivered bi-weekly for 2 months, compared to 45 sessions over 6 months of CET. ABCR has been tested in the EPP population and has shown positive results when delivered in person, hybrid and remotely. Although this therapy is demonstrating benefits for patients including improvement in daily functioning and social cognition, its effects on substance misuse have not been researched. This study aims to investigate whether treatment with ABCR helps patients with EPP reduce their alcohol and/or cannabis use.","conditions":["Psychosis","Alcohol Use Disorder","Cannabis Use Disorder"],"keywords":["alcohol","cannabis","action based cognitive remediation","psychosis"],"interventions":[{"type":"BEHAVIORAL","name":"Action-Based Cognitive Remediation"}],"enrollment":50,"startDate":"2026-03-27","completionDate":"2027-12-31","sex":"ALL","minAge":"16 Years","maxAge":"30 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* This study will enroll individuals 16-30 years of age from the Early Intervention Services for Psychosis programs in Nova Scotia and the Psychosis Intervention Early Recovery program in Newfoundland\n* Diagnosed with a primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder)\n* Less than 5 years of psychotic illness\n* Has problematic alcohol and/or cannabis use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT) or Cannabis Use Disorder Identification Test-Revised (CUDIT-R)).\n\nExclusion Criteria:\n\n* Current stimulant use disorder","locations":[{"facility":"Psychosis Intervention Early Recovery program","city":"St. John's","state":"Newfoundland and Labrador","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nova Scotia Early Psychosis Program","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rachel Church, MSc. OT","phone":"902-473-7474","email":"rachel.church@nshealth.ca"},{"name":"Candice E Crocker, PhD","phone":"902-473-3755","email":"candice.crocker@nshealth.ca"}],"primaryOutcomes":["Change in cannabis consumption","Change in problematic cannabis use","Change in alcohol consumption","Change in problematic alcohol use"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["st-johns-canada","halifax-canada"],"enrichment":{"headline":"Not a traditional drug phase: Action-Based Cognitive Remediation for Psychosis","inPlainEnglish":"Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected. The age of onset for psychotic disorders often begin during the critical years of youth and early adulthood, resulting in significant challenges for individuals and their families, including difficulties with thinking, relationships, and overall well-being.","whoItsFor":["Ages 16 Years to 30 Years","This study will enroll individuals 16-30 years of age from the Early Intervention Services for Psychosis programs in Nova Scotia and the Psychosis Intervention Early Recovery program in Newfoundland","Diagnosed with a primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, and unspecified schizophrenia spectrum disorder)","Less than 5 years of psychotic illness","Has problematic alcohol and/or cannabis use (score of 8 or higher on the World Health Organization Alcohol Use Disorders Identification Test (WHO-AUDIT) or Cannabis Use Disorder Identification Test-Revised (CUDIT-R))"],"whoShouldSkip":["Current stimulant use disorder"],"whatHappens":"If you join, the listed intervention(s) are Action-Based Cognitive Remediation. The registry lists allocation as randomized. Psychotic disorders impact 4.6 people per 1000 globally, with approximately 1.5 million Canadians affected.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.034Z"},{"nctId":"NCT07058077","title":"A Study of Enlicitide Decanoate (MK-0616, an Oral PCSK9 Inhibitor) in Children and Adolescents With Heterozygous Familial Hypercholesterolemia (MK-0616-029)","officialTitle":"An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants With Heterozygous Familial Hypercholesterolemia","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.\n\nThe goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a placebo.","conditions":["Heterozygous Familial Hypercholesterolemia (HeFH)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Enlicitide Decanoate"},{"type":"DRUG","name":"Placebo"}],"enrollment":153,"startDate":"2025-08-21","completionDate":"2033-12-04","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion criteria include, but are not limited to:\n\n* Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results\n* Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL\n* Is receiving either:\n\n  * An optimized daily dose of statin (± nonstatin LLT)\n  * A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative\n* Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B\n\nExclusion Criteria:\n\nExclusion criteria include, but are not limited to:\n\n* Has a history of homozygous FH based on genetic or clinical criteria, or history of known compound heterozygous FH, or double heterozygous FH\n* Has a history of nephrotic syndrome\n* Has any clinically significant malabsorption condition based on investigator assessment\n* Was previously treated/is being treated with certain other cholesterol lowering medications, including proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout","locations":[{"facility":"Nemours/Alfred I. duPont Hospital for Children ( Site 0001)","city":"Wilmington","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's National Medical Center ( Site 0015)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excel Medical Clinical Trials ( Site 0008)","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta Cardiology ( Site 0026)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital ( Site 0018)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Louis Children's Hospital ( Site 0014)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center ( Site 0016)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University ( Site 0013)","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Children s Hospital ( Site 1603)","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perth Children s Hospital ( Site 1601)","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Antwerpen ( Site 0601)","city":"Edegem","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universidade Federal Do Ceara ( Site 0201)","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Dante Pazzanese de Cardiology ( Site 0206)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Incor - Instituto do Coracao ( Site 0200)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocenter ( Site 0305)","city":"Concepción","state":"Biobio","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Explora Salud ( Site 0304)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Catolica de Chile ( Site 0300)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Capital Institute of Pediatrics ( Site 1908)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Anzhen Hospital. Capital Medical University ( Site 1917)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital ( Site 1915)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Fudan University ( Site 1906)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Children's Medical Center ( Site 1918)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Zhejiang University School of Medicine ( Site 1905)","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica de la Costa S.A.S. ( Site 0400)","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncomédica S.A.S ( Site 0401)","city":"Montería","state":"Departamento de Córdoba","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Cardiovascular de Colombia ( Site 0402)","city":"Piedecuesta","state":"Santander Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Valle del Lili ( Site 0403)","city":"Cali","state":"Valle del Cauca Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Detska nemocnice FN Brno ( Site 0701)","city":"Brno","state":"Brno-mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vseobecna fakultni nemocnice v Praze ( Site 0702)","city":"Prague","state":"Praha 2","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice v Motole ( Site 0700)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Childrens Hospital ( Site 0800)","city":"Helsinki","state":"Uusimaa","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Femme Mere Enfant ( Site 2101)","city":"Bron","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Freiburg ( Site 2203)","city":"Freiburg im Breisgau","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chutoen General Medical Center ( Site 2003)","city":"Kakegawa","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laboratorio de Patología Clínica del Hospital Universitario \"Dr. José Eleuterio González\" ( Site 0501)","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigacion Clinica de Oaxaca ( Site 0505)","city":"Oaxaca City","state":"Oaxaca","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"INVECORDIS S.C. ( Site 0503)","city":"Huixquilucan","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC, locatie AMC ( Site 1000)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Zealand Clinical Research (Christchurch) ( Site 1700)","city":"Christchurch","state":"Canterbury","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo Universitetssykehus Aker-Lipidklinikken ( Site 1100)","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instytut Centrum Zdrowia Matki Polki ( Site 1201)","city":"Lodz","state":"Łódź Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"National University Hospital-Paediatrics ( Site 1800)","city":"Singapore","state":"Central Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Central de Asturias ( Site 1303)","city":"Oviedo","state":"Asturias, Principado de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Santiago de Compostela ( Site 1300)","city":"Santiago de Compostela","state":"La Coruna","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"COMPLEJO HOSPITALARIO DE NAVARRA ( Site 1302)","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Childrens Hospital ( Site 1501)","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Childrens Hospital ( Site 1503)","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southampton General Hospital ( Site 1502)","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part A: Maximum Plasma Concentration (Cmax) of Enlicitide","Part A: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide","Part B: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)","Number of Participants Who Experience an Adverse Event (AE)","Number of Participants Who Discontinue Study Treatment Due to an AE"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["wilmington-delaware","washington-d-c-district-of-columbia","boca-raton-florida","atlanta-georgia","boston-massachusetts","st-louis-missouri","cincinnati-ohio","morgantown-west-virginia","clayton-australia","nedlands-australia","edegem-belgium","fortaleza-brazil","s-o-paulo-brazil","concepci-n-chile","santiago-chile","beijing-china","guangzhou-china","shanghai-china","hangzhou-china","barranquilla-colombia","monter-a-colombia","piedecuesta-colombia","cali-colombia","brno-czechia","prague-czechia","helsinki-finland","bron-france","freiburg-im-breisgau-germany","kakegawa-japan","monterrey-mexico","oaxaca-city-mexico","huixquilucan-mexico","amsterdam-netherlands","christchurch-new-zealand","oslo-norway","lodz-poland","singapore-singapore","oviedo-spain","santiago-de-compostela-spain","pamplona-spain","birmingham-united-kingdom","sheffield-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Enlicitide Decanoate for Heterozygous Familial Hypercholesterolemia (HeFH)","inPlainEnglish":"This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood. The goals of this study are to learn about the safety of enlicitide and if children tolerate it, what happens to enlicitide in a child's body over time, and if enlicitide works to lower cholesterol levels in children more than a dummy treatment (placebo).","whoItsFor":["Ages 6 Years to 17 Years","who can join include, but are not limited to:","Has possible or definite diagnosis of HeFH based on a locally accepted diagnostic algorithm or diagnosis by genetic testing results","Has a fasted LDL-C value (evaluated by the central laboratory) that is ≥130 mg/dL","Is receiving either:","An optimized daily dose of statin (± nonstatin LLT)","A nonstatin LLT with documented intolerance to at least 2 different statins, or documented intolerance to 1 statin plus refusal of statin therapy by the participant or legally acceptable representative","Is on a stable dose of all background LLTs for at least 30 days prior to screening, with no medication or dose changes planned during participation in Part A or Part B"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Enlicitide Decanoate, or Placebo. The registry lists allocation as randomized. This study is designed to learn if enlicitide decanoate is safe and effective to treat children and adolescents with heterozygous familial hypercholesterolemia (HeFH) and high amounts of low-density lipoprotein cholesterol (LDL-C) in the blood.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 153 people at 48 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.436Z"},{"nctId":"NCT07058155","title":"Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","officialTitle":"OPTIMAL Trial: Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The Cleveland Clinic","sponsorClass":"OTHER","summary":"Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver. CSPH raises the risk of life-threatening events like internal bleeding and liver failure. Unfortunately, treatment options for people who have both cirrhosis and severe obesity are very limited, especially when portal hypertension is present.\n\nThis study, called the OPTIMAL Trial, is a randomized clinical trial designed to evaluate whether combining two procedures improves health outcomes in this high-risk population. The first procedure, called TIPS (Transjugular Intrahepatic Portosystemic Shunt), is a minimally invasive treatment that reduces pressure in the liver by creating a pathway for blood to flow more easily. The second procedure is sleeve gastrectomy, a form of metabolic (bariatric) surgery that helps patients lose weight and improve related conditions like diabetes.\n\nThe study will compare two groups:\n\n1. One group will receive TIPS followed by sleeve gastrectomy (TIPS+SG).\n2. The other group will receive medical weight management (standard non-surgical care, including diet, lifestyle changes, and weight loss medications).\n\nAll participants will have severe obesity and cirrhosis with CSPH but will not have decompensated liver disease (such as large amounts of fluid in the abdomen, a history of variceal bleeding, or recent liver failure). Eligible participants will be randomly assigned to one of the two groups.\n\nThe main goal of the study is to determine whether the combination of TIPS + SG improves quality of life and leads to greater weight loss compared to medical therapy alone. The study will also monitor for any complications from either the procedures or the medical treatment.\n\nParticipants will be followed for 6 months after their treatment starts, with periodic assessments of their physical health, liver function, and overall well-being. Some participants may also be followed for a longer period to assess long-term outcomes.\n\nThis study hopes to provide high-quality evidence for a novel, stepwise treatment strategy that may help people with obesity and liver disease live longer, healthier lives. If successful, it could change how advanced liver disease and obesity are managed together, especially in patients who currently have few safe and effective options. All study care is provided at Cleveland Clinic, Cleveland, Ohio, USA.","conditions":["Liver Cirrhoses","Portal Hypertension Related to Cirrhosis","Severe Obesity","TIPS"],"keywords":["Sleeve Gastrectomy","Transjugular Intrahepatic Portosystemic Shunt (TIPS)","Bariatric Surgery / Metabolic Surgery","Clinically Significant Portal Hypertension (CSPH)","Health-Related Quality of Life (HRQOL)","SF-36 Questionnaire","Weight Loss","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","Randomized Controlled Trial"],"interventions":[{"type":"PROCEDURE","name":"Transjugular Intrahepatic Portosystemic Shunt (TIPS)"},{"type":"PROCEDURE","name":"Sleeve Gastrectomy"},{"type":"DRUG","name":"Anti-Obesity Pharmacotherapy (Class Effect)"},{"type":"BEHAVIORAL","name":"Lifestyle Counseling - Diet & Physical-Activity Program"}],"enrollment":70,"startDate":"2025-12-17","completionDate":"2029-02-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Is a candidate for general anesthesia\n2. Is ≥18 and ≤70 years old at the time of signing the informed consent\n3. Has a BMI ≥35 and ≤85 kg/m2 at the time of first study visit\n4. Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines \\[39\\]\n5. Has insurance coverage for metabolic surgery\n6. Patients who are currently receiving or have previously received anti-obesity medicines will be considered for participation\n7. Liver cirrhosis as determined via liver biopsy or noninvasive liver disease assessment\n8. CSPH as determined by HVPG of ≥ 10-12 mmHg, presence of esophagogastric varices, moderate-to-severe portal hypertensive gastropathy, dilated portal vein (\\>13 mm), biphasic or reverse portal vein flow, enlarged paraumbilical veins, splenorenal collaterals, or dilated left and short gastric veins.\n9. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study.\n10. Has a negative urine pregnancy test at the first visit and at the randomization visits for women of childbearing potential.\n11. Women of childbearing age must agree to use reliable method of contraception for 2 years.\n\nExclusion Criteria\n\n1. Prior bariatric and metabolic surgery of any kind\n\n   • Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed.\n2. Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery\n3. History of solid organ transplant\n4. Severe pulmonary disease defined as FEV1 \\< 50% of predicted value\n5. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)\n6. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V\n7. Left ventricular ejection fraction \\<25% at the time of screening\n8. Myocardial infarction, unstable angina, stroke, heart surgery, coronary stent placement in the past 6 months\n9. Presence of large hiatal hernia (\\>7 cm)\n10. Presence of erosive esophagitis (LA Grade C and D)\n11. Presence of active Crohn's disease\n12. Psychiatric disorders including (but not limited to) dementia, active psychosis, severe depression requiring 3 or more medications, history of suicide attempts, active alcohol, or substance abuse within the previous 12 months that in the opinion of the investigators could disqualify the patient from metabolic surgery\n13. Pregnancy, the intention of becoming pregnant, or not using adequate contraceptive measures\n14. Breastfeeding\n15. Diagnosis of malignancy within the preceding 1 year, including intra- or extra-hepatic malignancy. This includes known hepatocellular carcinoma or evidence of OPTN-V lesion on imaging (except squamous cell and basal cell cancer of the skin).\n16. Clinical judgment that life expectancy is less than 2 years\n17. Use of investigational therapy within 3 months prior to signing the consent\n18. Acute pancreatitis \\< 90 days before screening\n19. Portal vein thrombosis\n20. Decompensated cirrhosis: moderate-to-large volume ascites, hepatic encephalopathy, or patients undergoing liver transplant evaluation.\n\n    • We will include patients with prior variceal hemorrhage or small volume ascites\n21. Total bilirubin \\> 3 mg/dl within 1 month of screening\n22. INR \\> 1.7 within 1 month of screening\n23. Platelets \\<50,000 per microliter within 1 month of screening\n24. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to the first study visit.\n\n    • Defined as more than 14 units/week for females (\\>1 drink per day) and more than 21 units/week for males (\\>2 drinks per day) on average, where one unit of alcohol is equivalent to a 12-ounce beer, 4-ounce glass of wine, or 1-ounce shot of hard liquor.\n25. Chronic renal insufficiency with estimated glomerular filtration rate (eGFR) below 45 mL/min/1.73 m2 or being on dialysis within 1 month of screening.\n26. Known cases of Acquired Immune Deficiency Syndrome (AIDS)\n27. Unable to understand the risks, benefits, and compliance requirements of study\n28. Lack capacity to give informed consent\n29. Plans to move outside the primary location of study (within 3-hour distance of Cleveland) within the next 6 months.\n30. Previous participation in this trial and got randomized to one of the study groups but did not proceed.\n31. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study","locations":[{"facility":"Cleveland Clinic Main Campus","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ghazal F Daftari, MD","phone":"857-498-0045","email":"daftarg@ccf.org"}],"primaryOutcomes":["Change in SF-36 Physical Component Summary (PCS) Score From Baseline to 6 Months"],"hasResults":false,"conditionSlugs":["als","obesity","hypertension"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Phase 4: testing Anti-Obesity Pharmacotherapy (Class Effect) for Liver Cirrhoses","inPlainEnglish":"Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity. Many patients with cirrhosis also develop a condition called clinically significant portal hypertension (CSPH), which is increased pressure in the veins of the liver.","whoItsFor":["Ages 18 Years to 70 Years","Is a candidate for general anesthesia","Has a body-mass index (BMI) ≥35 and ≤85 kg/m2 at the time of first study visit","Is eligible for metabolic surgery (SG) based on the ASMBS/IFSO 2022 guidelines \\[39\\]","Has insurance coverage for metabolic surgery","Patients who are currently receiving or have previously received anti-obesity medicines will be considered for participation","Liver cirrhosis as determined via liver biopsy or noninvasive liver disease assessment","Has a negative urine pregnancy test at the first visit and at the randomization visits for women of childbearing potential"],"whoShouldSkip":["Prior bariatric and metabolic surgery of any kind","Reversed procedures such as gastric band or intragastric balloon that have been removed at least 3 months prior to the first study visit are allowed","Prior complex foregut surgery including any esophageal and gastric surgeries, anti-reflux procedures, biliary diversion, and complex trauma surgery","History of solid organ transplant","Severe pulmonary disease defined as FEV1 \\< 50% of predicted value","Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)","Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V"],"whatHappens":"If you join, the listed intervention(s) are Transjugular Intrahepatic Portosystemic Shunt (TIPS), Sleeve Gastrectomy, or Anti-Obesity Pharmacotherapy (Class Effect). The registry lists allocation as randomized. Cirrhosis is a form of advanced liver disease that can lead to serious complications, especially when combined with severe obesity.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 70 people at Cleveland. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.729Z"},{"nctId":"NCT07059884","title":"Distance-Based Exercise to Preserve Function and Prevent Disability","officialTitle":"Distance-Based Exercise to Preserve Function and Prevent Disability","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Alliance for Clinical Trials in Oncology","sponsorClass":"OTHER","summary":"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength. These side effects can make it difficult to work, take care of family, and do other things the patient wants to do. Preliminary research shows that exercise can help prevent some of these side effects, but it can be more difficult to start an exercise program when a patient is receiving cancer treatment. The exercise program in this study is delivered through telehealth (TH) video calls. The TH sessions are delivered by trained staff that supervise resistance exercises. The trained staff also provide guidance to the patient on completing unsupervised aerobic sessions on their own. This may be a successful way to deliver an exercise program and make it easier for cancer patients to exercise in their own home during treatment.","conditions":["Localized Malignant Solid Neoplasm","Anal Cancer","Bladder (Urothelial, Transitional Cell) Cancer","Breast Cancer","Cervical Cancer","Colon Cancer","Endometrial Cancer","Esophageal Cancer","Gall Bladder Cancer","Gastric Cancer","Kidney Cancer","Liver Cancer","Lung Cancer","Head and Neck Cancer","Ovarian Cancer","Pancreatic Cancer","Prostate Cancer","Rectal Cancer","Sarcoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Exercise intervention"},{"type":"OTHER","name":"Telemedicine"},{"type":"OTHER","name":"Aerobic Exercise Intervention"},{"type":"OTHER","name":"Exercise Intervention"},{"type":"PROCEDURE","name":"Accelerometry"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"OTHER","name":"Interview"},{"type":"OTHER","name":"Electronic Health Record Review"}],"enrollment":104,"startDate":"2026-02-11","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must have histologically confirmed diagnosis of one of the following cancers: anus, bladder, breast, cervix, colon/rectum, endometrium, esophagus, gallbladder, head/neck, kidney, liver, lung, ovary, pancreas, prostate, sarcoma, stomach\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Participants must be initiating outpatient cytotoxic chemotherapy for curative intent of at least 10 weeks duration (with or without concurrent radiation, immunotherapy, or other targeted therapy). Patients must be enrolled and baseline measures collected on or before administration of their second cycle of cytotoxic therapy. Patients receiving outpatient cytotoxic chemotherapy for curative intent in the neoadjuvant or adjuvant setting are eligible. Patients receiving definitive chemoradiation for the tumors listed above, are also eligible. Regimens of immunotherapy or monoclonal antibodies ONLY are not eligible\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Currently no self-report of engagement in competitive sports (e.g. not training for running races, triathlons, etc.) AND no self-report of twice weekly progressive resistance exercise training for at least 3 consecutive months within the past year\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Predicted 6MWT distance of 550 meters or less\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Concurrent enrollment in treatment or supportive care trials (other than those focused on weight loss or exercise) is allowed with the permission of the Alliance Executive Officer and both studies' study chairs\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read intervention materials and work with a coach through telehealth sessions\n* REGISTRATION ELIGIBILITY CRITERIA (STEP 1): The trial is unable to accommodate the needs of deaf or blind participants as the study relies on language and visualization of exercise through telehealth sessions\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Clinicians and research staff from enrolling sites who meet following criterion will be deemed eligible to participate as a clinical stakeholder:\n\n  \\* Providing clinical care for participating patients on this study\n* CLINICAL STAKEHOLDER ELIGIBILITY CRITERIA: Ability to speak and understand English\n\nExclusion Criteria:\n\n\\-","locations":[{"facility":"Kaiser Permanente Dublin","city":"Dublin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Fremont","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fresno Orchard Plaza","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente- Modesto MOB II","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Modesto","city":"Modesto","state":"California","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Kaiser Permanente-Oakland","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-South Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Teresa-San Jose","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser San Rafael-Gallinas","city":"San Rafael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Medical Center - Santa Clara","city":"Santa Clara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Santa Rosa","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Vallejo","city":"Vallejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-Walnut Creek","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Cancer Institute - Kernersville","city":"Kernersville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Cancer Institute - Mount Airy","city":"Mount Airy","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Forsyth Medical Center","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center at Butler Health System","city":"Butler","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center - Passavant - Cranberry","city":"Cranberry Township","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRMC Cancer Center","city":"Indiana","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center - New Castle","city":"New Castle","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Magee Womens Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Passavant Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC-Saint Clair Hospital Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Cancer Center at UPMC Northwest","city":"Seneca","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Memorial Regional Medical Center","city":"Mechanicsville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Saint Francis Medical Center","city":"Midlothian","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Saint Mary's Hospital","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lilli Johnson","phone":"773-834-4091","email":"cancercontrolprotocols@alliancenctn.org"}],"primaryOutcomes":["Percentage of completed exercise sessions (Feasibility)","Intervention attrition rate (Feasibility)"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","pancreatic-cancer","ovarian-cancer","kidney-cancer","bladder-cancer","liver-cancer","stomach-cancer","cervical-cancer","endometrial-cancer","head-and-neck-cancer","als"],"drugSlugs":[],"locationSlugs":["dublin-california","fremont-california","fresno-california","modesto-california","oakland-california","sacramento-california","san-francisco-california","san-jose-california","san-rafael-california","santa-clara-california","santa-rosa-california","vallejo-california","walnut-creek-california","boston-massachusetts","kernersville-north-carolina","mount-airy-north-carolina","winston-salem-north-carolina","butler-pennsylvania","cranberry-township-pennsylvania","indiana-pennsylvania","new-castle-pennsylvania","pittsburgh-pennsylvania","seneca-pennsylvania","mechanicsville-virginia","midlothian-virginia","richmond-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Exercise intervention for Localized Malignant Solid Neoplasm","inPlainEnglish":"This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home. Treatments for cancer can cause side effects such as fatigue and loss of strength.","whoItsFor":["Ages 18 Years to any","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age 18-64 years","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have metastatic cancer","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot be pregnant, because this study involves remotely delivered exercise, and cannot be breast-feeding as patients must be receiving cytotoxic chemotherapy, during which breast-feeding is contraindicated","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients cannot have documentation in the medical record of current alcohol, substance abuse, or dementia","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Engaged in full time gainful employment of at least 30 hours per week at the time of cancer diagnosis","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Self-reported ability to walk for 6 minutes (use of assistive devices will be allowed)","REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not participating in another weight loss, physical activity, or dietary intervention clinical trial"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Exercise intervention, Telemedicine, or Aerobic Exercise Intervention. The registry lists allocation as na. This clinical trial studies whether an exercise program can be successfully delivered to patients receiving treatment for cancer through virtual sessions and allow patients to exercise in their own home.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 104 people at 30 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.915Z"},{"nctId":"NCT07060807","title":"A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)","officialTitle":"An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04).","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.\n\n* HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread\n* HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2\n* Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles\n* Metastatic means the cancer has spread to other parts of the body\n\nTreatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment. The main goal of this study is to learn if people who receive patritumab deruxtecan (also known as HER3-DXd and MK-1022) live longer overall or without the cancer growing/spreading, compared to people who receive chemotherapy or a different drug called trastuzumab deruxtecan.","conditions":["Breast Neoplasms"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Patritumab deruxtecan"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Nab-paclitaxel"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Pegylated liposomal doxorubicin"},{"type":"BIOLOGICAL","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Rescue Medication"}],"enrollment":1000,"startDate":"2025-07-21","completionDate":"2033-07-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 (HER2)- invasive breast carcinoma that is either locally advanced disease not amenable to resection with curative intent (herein called unresectable) or metastatic disease not treatable with curative intent\n* Has centrally-confirmed HR+ and HER2- results and human epidermal growth factor receptor 3 (HER3) evaluable results from a biopsy obtained from a distant metastatic site or a locally advanced lesion on or after the time of diagnosis of locally advanced unresectable or metastatic breast cancer. A new biopsy obtained after progression of the most recent line of therapy is preferred\n* Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:\n\n  * Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or\n  * Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor\n* Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has breast cancer amenable to treatment with curative intent\n* Is eligible to receive additional endocrine-based treatment in the advanced setting as determined by the investigator\n* Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) where poly (ADP-ribose) polymerase (PARP) inhibitor(s) is a potential treatment option\n* Has current visceral crisis or is at risk for impending visceral crisis that has or may cause imminent organ compromise and/or other life-threatening complications\n* Has any of the following: a pulse oximeter reading \\<92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has ≥Grade 2 peripheral neuropathy.\n* Has clinically significant corneal disease\n* Has received prior chemotherapy for unresectable locally advanced or metastatic breast cancer\n* Has received prior treatment with an anti-HER3 antibody and/or antibody-drug conjugate that consists of a topoisomerase I inhibitor (eg, T-DXd) or any other topoisomerase I inhibitor therapy\n* Has received prior systemic anticancer therapy within 4 weeks (or 5 half-lives, whichever is shorter) before randomization; participants previously treated with ET plus a CDK4/6 inhibitor may participate as long as at least 2 weeks have elapsed since the last dose of therapy was administered\n* Has received prior radiotherapy for non-central nervous system disease, or required corticosteroids for radiation-related toxicities, within 14 days of the first dose of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has history of (noninfectious) interstitial lung disease (ILD) or pneumonitis irrespective of steroid use, or has current ILD or suspected ILD, or ILD that cannot be ruled out by imaging at Screening\n* Has severe hypersensitivity (≥Grade 3) to HER3-DXd and/or any of its excipients\n* Has severe hypersensitivity (≥Grade 3) to all the available TPC and/or any of their excipients","locations":[{"facility":"Southern Cancer Center (SCC) ( Site 8000)","city":"Daphne","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Arizona Cancer Center - North Campus ( Site 0055)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Hematology Oncology Medical Group ( Site 0026)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital Presbyterian ( Site 0025)","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 0021)","city":"Grand Junction","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Hematology Consultants (MOHC) ( Site 8002)","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0024)","city":"Altamonte Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Comprehensive Hematology Oncology ( Site 0060)","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Lexington ( Site 0050)","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Hamburg ( Site 0071)","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists ( Site 9503)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey ( Site 0033)","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Kaseman Hospital ( Site 0072)","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico Comprehensive Cancer Center ( Site 0047)","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presbyterian Rust Jorgensen Cancer ( Site 0073)","city":"Rio Rancho","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queens Hospital Cancer Center ( Site 0011)","city":"Jamaica","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optum Medical Care, PC ( Site 0009)","city":"Westbury","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Cancer Institute ( Site 0019)","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Oncology Specialists ( Site 0074)","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0020)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center Magee-Womens Hospital ( Site 0058)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Associates Of York ( Site 0063)","city":"York","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 7000)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology ( Site 0068)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8003)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JPS Health Network ( Site 0067)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Gulf Coast ( Site 8006)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants P.A. ( Site 0061)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Central/South Texas ( Site 8005)","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mays Cancer Center ( Site 0049)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates (VOA) ( Site 8001)","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenandoah Oncology ( Site 8004)","city":"Winchester","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Medical Specialties, PLLC ( Site 0062)","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Circuit Clinical/SSM Health Dean Medical Group ( Site 0039)","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Aleman ( Site 0200)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar ( Site 0201)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Privado de RMI Rio Cuarto ( Site 0207)","city":"Río Cuarto","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncología de Rosario ( Site 0208)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0202)","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Córdoba ( Site 0206)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 2300)","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chris O'Brien Lifehouse ( Site 2302)","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Medical Centre ( Site 2301)","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred Hospital ( Site 2305)","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Charles Gairdner Hospital ( Site 2304)","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Câncer de Recife ( Site 0302)","city":"Recife","state":"Pernambuco","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Câncer ( Site 0301)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital do Câncer Mãe de Deus ( Site 0300)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia Saint Gallen ( Site 0308)","city":"Santa Cruz do Sul","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"ANIMI - Unidade de Tratamento Oncologico ( Site 0306)","city":"Lages","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Paulistano ( Site 0304)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Moncton Hospital ( Site 0101)","city":"Moncton","state":"New Brunswick","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Research Institute ( Site 0105)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Center ( Site 0116)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 0113)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saskatoon Cancer Centre ( Site 0106)","city":"Saskatoon","state":"Saskatchewan","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIDO SpA ( Site 0408)","city":"Temuco","state":"Araucania","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Arturo López Pérez ( Site 0400)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncovida ( Site 0402)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oncología de Precisión ( Site 0410)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica MEDS La Dehesa ( Site 0405)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill ( Site 0401)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anhui Provincial Cancer Hospital ( Site 3140)","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Hospital Chinese Academy of Medical Sciences ( Site 3100)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital ( Site 3138)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University ( Site 3101)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing Three Gorges Central Hospital's ( Site 3128)","city":"Wanzhou","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated hospital of Xiamen University ( Site 3120)","city":"Fujian","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center ( Site 3102)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangmen Central Hospital ( Site 3132)","city":"Jiangmen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangxi Medical University Affiliated Tumor Hospital ( Site 3118)","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital ( Site 3108)","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiangyang Central Hospital ( Site 3123)","city":"Xiangyang","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital ( Site 3134)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Cancer Hospital ( Site 3107)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital ( Site 3105)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanchang People's Hospital ( Site 3124)","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jilin Cancer Hospital ( Site 3116)","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xi'an International Medical Center Hospital ( Site 3122)","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Cancer Hospital of Shandong First Medical University ( Site 3115)","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital. ( Site 3110)","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University ( Site 3139)","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xinjiang Medical University Cancer Hospital - Urumqi ( Site 3112)","city":"Ürümqi","state":"Xinjiang","country":"China","status":"COMPLETED","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital ( Site 3117)","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital ( Site 3109)","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province ( Site 3137)","city":"Linhai","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Promotora Médica Las Américas S.A. ( Site 0503)","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0502)","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional De Cancerologia ( Site 0504)","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0501)","city":"Valledupar","state":"Cesar Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMAT S.A.S ( Site 0500)","city":"Montería","state":"Departamento de Córdoba","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Brest ( Site 0904)","city":"Brest","state":"Finistere","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CENTRE LEON BERARD ( Site 0900)","city":"Lyon","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0901)","city":"Rouen","state":"Seine-Maritime","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy ( Site 0903)","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Ulm-Frauenheilkunde und Geburtshilfe ( Site 1001)","city":"Ulm","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Lippe Detmold ( Site 1008)","city":"Detmold","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Dortmund Klinikzentrum Mitte ( Site 1005)","city":"Dortmund","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Mutterhaus der Borromäerinnen ( Site 1018)","city":"Trier","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum des Saarlandes-Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedi ( Site 1003)","city":"Homburg","state":"Saarland","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Chemnitz gGmbH ( Site 1016)","city":"Chemnitz","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"\"ALEXANDRA\" GENERAL HOSPITAL OF ATHENS - DEPARTMENT OF CLINICAL THERAPEUTICS ( Site 1106)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Athens \"Laiko\" ( Site 1105)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aretaieio Hospital ( Site 1103)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital of Heraklion ( Site 1102)","city":"Heraklion","state":"Irakleio","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"European Interbalkan Medical Center-Oncology Department ( Site 1101)","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital ( Site 3301)","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Hospital. 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(OS)"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["daphne-alabama","tucson-arizona","los-angeles-california","newport-beach-california","grand-junction-colorado","newark-delaware","altamonte-springs-florida","st-petersburg-florida","lexington-kentucky","reno-nevada","hackensack-new-jersey","new-brunswick-new-jersey","albuquerque-new-mexico","rio-rancho-new-mexico","jamaica-new-york","westbury-new-york","charlotte-north-carolina","winston-salem-north-carolina","cincinnati-ohio","pittsburgh-pennsylvania","york-pennsylvania","nashville-tennessee","dallas-texas","fort-worth-texas","houston-texas","mcallen-texas","san-antonio-texas","norfolk-virginia","winchester-virginia","tacoma-washington","madison-wisconsin","ciudad-autonoma-de-buenos-aires-argentina","mar-del-plata-argentina","buenos-aires-argentina","r-o-cuarto-argentina","rosario-argentina","caba-argentina","c-rdoba-argentina","blacktown-australia","camperdown-australia","clayton-australia","melbourne-australia","nedlands-australia","recife-brazil","natal-brazil","porto-alegre-brazil","santa-cruz-do-sul-brazil","lages-brazil","s-o-paulo-brazil","moncton-canada","toronto-canada","montreal-canada","saskatoon-canada","temuco-chile","santiago-chile","hefei-china","beijing-china","chongqing-china","wanzhou-china","fujian-china","guangzhou-china","jiangmen-china","nanning-china","zhengzhou-china","xiangyang-china","changsha-china","nanjing-china","nanchang-china","changchun-china","xian-china","jinan-china","chengdu-china","r-mqi-china","hangzhou-china","linhai-china","medell-n-colombia","bogot-colombia","valledupar-colombia","monter-a-colombia","brest-france","lyon-france","rouen-france","villejuif-france","ulm-germany","detmold-germany","dortmund-germany","trier-germany","homburg-germany","chemnitz-germany","athens-greece","heraklion-greece","thessaloniki-greece","hong-kong-hong-kong","kecskem-t-hungary","ny-regyh-za-hungary","budapest-hungary","beersheba-israel","haifa-israel","jerusalem-israel","ramat-gan-israel","bergamo-italy","milan-italy","naples-italy","roma-italy","nagoya-japan","matsuyama-japan","sapporo-japan","tsu-japan","hirakata-japan","sakai-japan","hidaka-japan","sunto-gun-japan","ch-japan","minato-japan","shinagawa-japan","akita-japan","chiba-japan","fukuoka-japan","fukushima-japan","hiroshima-japan","kagoshima-japan","okayama-japan","osaka-japan","guadalajara-mexico","monterrey-mexico","quer-taro-city-mexico","chihuahua-city-mexico","oaxaca-city-mexico","concepci-n-peru","san-borja-peru","san-isidro-peru","bydgoszcz-poland","warsaw-poland","bialystok-poland","s-upsk-poland","olsztyn-poland","koszalin-poland","lodz-poland","seongnam-south-korea","gangnam-gu-south-korea","jongno-gu-south-korea","seoul-south-korea","badalona-spain","santander-spain","a-coru-a-spain","barcelona-spain","madrid-spain","seville-spain","chiayi-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","bangkoknoi-thailand","dusit-thailand","ratchathewi-thailand","hat-yai-thailand","muang-thailand","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","diyarbak-r-turkey-t-rkiye","istanbul-turkey-t-rkiye","mersin-turkey-t-rkiye","rize-turkey-t-rkiye","samsun-turkey-t-rkiye","london-united-kingdom","leicester-united-kingdom","manchester-united-kingdom","hanoi-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 3: testing Patritumab deruxtecan for Breast Neoplasms","inPlainEnglish":"Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic. * HR positive (HR+) means the cancer cells have proteins that attach to estrogen or progesterone (hormones) which help the cancer to grow and spread * HER2 negative (HER2-) means the cancer cells have a low amount of a protein called HER2 * Unresectable locally advanced means the cancer cannot be completely removed by surgery and has spread into nearby tissue or muscles * Metastatic means the cancer has spread to other parts of the body Treatment for this type of breast cancer usually includes endocrine therapy (ET) and sometimes a second treatment.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Must have had progression or recurrence on prior cyclin-dependent kinase (CDK)4/6 inhibitor + endocrine therapy (ET) with one of the following:","Radiographic disease progression, as assessed by the investigator, on CDK4/6 inhibitor + ET as 1L for treatment of unresectable locally advanced or metastatic HR+/HER2- breast cancer. CDK4/6 inhibitor + ET must be the only line of therapy received in the advanced setting, or","Disease recurrence, either radiographic and/or confirmed histologically via biopsy as assessed by the investigator, while on adjuvant ET in combination with a CDK4/6 inhibitor OR within 24 months from the date of last dose of adjuvant CDK4/6 inhibitor","Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology","Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy","Has an Eastern Cooperative Oncology Group performance status of 0 or 1 assessed within 7 days before randomization"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Patritumab deruxtecan, Paclitaxel, or Nab-paclitaxel. The registry lists allocation as randomized. Researchers are looking for other ways to treat breast cancer (BC) that is hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+/HER2-) and either unresectable locally advanced or metastatic.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 206 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.342Z"},{"nctId":"NCT07061574","title":"A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","officialTitle":"A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\<21 with recent-onset stage 3 T1D.","conditions":["Type 1 Diabetes","New Onset"],"keywords":["ATG, Verapamil, Adalimumab"],"interventions":[{"type":"DRUG","name":"Anti-thymocyte globulin (ATG)"},{"type":"DRUG","name":"verapamil extended-release capsule"},{"type":"DRUG","name":"Adalimumab"}],"enrollment":120,"startDate":"2026-03-10","completionDate":"2030-04-15","sex":"ALL","minAge":"9 Years","maxAge":"20 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomized within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit.\n2. At least one positive T1D auto-antibody.\n\n   * If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required.\n   * Insulin auto-antibodies are only considered if exogenous insulin use is \\<10 days when blood is drawn.\n3. Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to randomization.\n4. Age 9 to \\<21 years at the time of randomization.\n5. Body weight \\>30kg.\n6. BMI \\<95th percentile for age and gender.\n7. Willing to comply with intensive diabetes management.\n8. Female participants with childbearing potential are not currently pregnant, are willing to avoid pregnancy and breastfeeding, and to undergo pregnancy testing prior to MMTTs for the duration of the study.\n\n   a. Women of childbearing potential (WOCBP) must use an acceptable form of birth control. Acceptable forms include oral/injection contraceptives, transdermal contraceptives, diaphragm, intrauterine devices, condoms with spermicide, documented surgical sterilization of either the participant or their partner or abstinence.\n9. Male participants with potential to father children must be willing to use abstinence or adequate contraceptive methods for the duration of the study.\n\n   a. Males must agree to be sexually abstinent or use a condom and agree not to donate sperm for the treatment period and for a minimum of 1 spermatogenesis cycle (90 days after last dose of study drug) after last treatment.\n10. Willing to provide informed consent and child assent as applicable.\n11. Willing to provide their primary endocrinologist's contact information and have their primary endocrinologist notified of their participation\n12. Sufficient cognitive ability, per investigator judgment, to provide informed consent for study participation on an IRB approved consent form.\n13. Able to read and understand English or Spanish (both participant and legally authorized representative, if applicable).\n14. Must be fully vaccinated for age.\n15. Must have been vaccinated for flu (if currently in flu season).\n16. Must be willing to not receive live vaccines throughout the treatment period.\n17. Must be willing to not use any non-insulin glucose-lowering agents such as GLP-1 agonists (including for weight loss indication), symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas) for the duration of study treatment. Participants are required to go off these drugs at least 30 days prior to screening.\n\nKey Exclusion Criteria:\n\n1. Prior treatment with ATG or known allergy to ATG or rabbit-derived products.\n2. Local lab draw at screening:\n\n   1. Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\<3,000 leukocytes /μL), neutropenia (\\<1,500 neutrophils/μL), lymphopenia (\\<800 lymphocytes/μL).\n   2. Thrombocytopenia (\\<100,000 platelets/μL) or anemia (hemoglobin \\< 10g/dL).\n   3. Leukocytosis (\\>14,000/μL)\n3. Infections:\n\n   1. Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization.\n   2. Have active signs or symptoms of acute infection at the time of randomization.\n   3. Have evidence of prior or current tuberculosis infection as assessed interferon gamma release assay (QuantiFERON-TB Gold), or a positive test for latent tuberculosis.\n   4. Have evidence of current or past HIV or Hepatitis B or current Hepatitis C infection.\n   5. History of serious bacterial, viral, fungal, or other opportunistic infections.\n4. Have active signs or symptoms of CMV or EBV compatible illness lasting more than 7 days within 30 days of randomization.\n5. Have positive CMV and/or EBV PCR test within 30 days prior to randomization.\n6. Have positive COVID-19 self-antigen test within 3 days of randomization.\n7. History of underlying cardiac disease (ex. left ventricular dysfunction, hypertrophic cardiomyopathy), certain arrhythmias (e.g. AV block, accessory pathway such as Wolff- Parkinson-White or Lown-Ganong-Levine syndromes) or abnormal ECG (unless cleared by cardiology).\n8. Blood pressure (either systolic or diastolic) \\<5th percentile for age, gender, and height on two out of three measurements.\n9. Pulse \\<2.5th percentile for age and gender on two out of three measurements.\n10. History of vasovagal syncopal episodes related to hypotension.\n11. History of malignancies other than of skin.\n12. Use of medications likely to interfere with study results:\n\n    1. Any immunomodulators, including systemic steroids or participation in prior research study in which a potential participant received an immunomodulatory agent (may participate if received placebo only).\n    2. Current or previous use of Teplizumab, Adalimumab, or Verapamil.\n    3. Ongoing use of medications known to influence glycemia or glucose tolerance. Only topical steroids are allowed.\n13. Need to use of any of the following medications during the study: beta blocker, seizure medication (carbamazepine, phenobarbital, phenytoin), other antihypertensive medications, HMG-CoA reductase inhibitors, lithium, theophylline, clonidine.\n14. Receipt of live vaccine (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, bacillus Calmette-Guerin, and smallpox) within the 90 days before randomization.\n15. Any known hypersensitivity reaction to any of the study medications or their components.\n16. Unable to swallow pills (tested with an inert imitation tablet in clinic at screening).\n17. History of significant allergy (e.g., anaphylaxis) to milk or soy proteins in the Boost drink required for study MMTT testing.\n18. Current use of hydroxyurea or unable to avoid hydroxyurea use during the study (interferes with accuracy of Dexcom sensor).\n19. Established history of allergy or severe reaction to adhesive or tape that must be used in the study.\n20. Participation in another treatment research study that involves diabetes care or immune modulation, unless the participant is able to confirm that they were in the placebo arm.\n21. Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:\n\n    1. Alcohol or drug abuse\n    2. Untreated or inadequately treated mental illness\n    3. Liver disease or LFTs \\>2x ULN.\n    4. Renal disease or creatinine greater than 1.5x ULN.\n    5. Other autoimmune diseases except for stable and treated hypothyroidism Graves' disease, or celiac disease (e.g., symptom-free on a gluten free diet).\n    6. Nervous system disorder including but not limited to Guillain-Barre Syndrome, multiple sclerosis, progressive multifocal leukoencephalopathy.\n    7. History of multiple abdominal surgeries and/or at increased risk for bowel obstruction.\n22. Any clinical or laboratory conditions that the investigator feels would interfere with the study or participant safety (e.g., increased risk to pre-existing disease).\n\nAny lab abnormality believed to be transient may be repeated at the discretion of the site PI. If repeat value does not preclude participation, and potential participant would otherwise qualify for the study, then may proceed with enrollment per investigator discretion.\n\n\\-","locations":[{"facility":"UCLA","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCSF","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Robert Henderson, MS","phone":"813-975-8690","email":"rhenderson@jaeb.org"}],"primaryOutcomes":["Stimulated C-peptide AUC"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["los-angeles-california","san-francisco-california","new-haven-connecticut","gainesville-florida","miami-florida","indianapolis-indiana","minneapolis-minnesota","buffalo-new-york","pittsburgh-pennsylvania","houston-texas","seattle-washington"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Anti-thymocyte globulin (ATG) for Type 1 Diabetes","inPlainEnglish":"This multi-center randomly assigned controlled trial will assess the safety and how well it works of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\<21 with recent-onset stage 3 T1D.","whoItsFor":["Ages 9 Years to 20 Years","Recent-onset stage 3 T1D diagnosed by standard ADA criteria, with the ability to be randomly assigned within 6 months from the date of T1D diagnosis and within 37 days of Screening Visit","At least one positive T1D auto-antibody","If clearly positive (≥20% above local lab's ULN) at screening, repeat antibody testing for central lab is not required","Insulin auto-antibodies are only considered if exogenous insulin use is \\<10 days when blood is drawn","Must have stimulated C-peptide levels ≥0.2 pmol/mL (≥0.6 ng/mL) measured during MMTT conducted prior to randomization","Age 9 to \\<21 years at the time of randomization","Body weight \\>30kg"],"whoShouldSkip":["Prior treatment with ATG or known allergy to ATG or rabbit-derived products","Local lab draw at screening:","Immunodeficient or have clinically significant chronic lymphopenia: Leukopenia (\\<3,000 leukocytes /μL), neutropenia (\\<1,500 neutrophils/μL), lymphopenia (\\<800 lymphocytes/μL)","Thrombocytopenia (\\<100,000 platelets/μL) or anemia (hemoglobin \\< 10g/dL)","Leukocytosis (\\>14,000/μL)","Ongoing infection or had recently had a major infection requiring hospitalization or intravenous antibiotics.within 30 days prior to randomization","Have active signs or symptoms of acute infection at the time of randomization"],"whatHappens":"If you join, the listed intervention(s) are Anti-thymocyte globulin (ATG), verapamil extended-release capsule, or Adalimumab. The registry lists allocation as randomized. This multi-center randomly assigned controlled trial will assess the safety and how well it works of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \\<21 with recent-onset stage 3 T1D.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.265Z"},{"nctId":"NCT07061964","title":"Combining Immunotherapy and Radiation Therapy to Help Patients Avoid Bladder Removal After Treatment Shrinks Muscle Invasive Bladder Cancer, BRIGHT Trial","officialTitle":"Single Arm Phase II Study of Bladder Preservation With Immunoradiotherapy After a Clinically Meaningful Response to Neoadjuvant Therapy in Patients With Muscle Invasive Bladder Cancer (BRIGHT)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.","conditions":["Muscle Invasive Bladder Urothelial Carcinoma","Stage II Bladder Cancer AJCC v8","Stage IIIA Bladder Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Cystoscopy"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"RADIATION","name":"Photon Beam Radiation Therapy"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"PROCEDURE","name":"Transurethral Resection of Bladder Tumor"}],"enrollment":111,"startDate":"2025-11-25","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)\n* Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0\n* Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed\n\n  * NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT\n* Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT\n* Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement\n\n  * NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)\n* Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT\n* Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology\n* Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy\n\n  * NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\\> 50%) of the tumor is urothelial cell carcinoma\n* Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)\n* Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \\[GC\\] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor\n* Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC\n\n  * NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed\n* Participants must not have had prior pelvic radiotherapy\n* Participants must not have received a live attenuated vaccination within 28 days prior to registration\n* Participants with conditions requiring immunosuppressive doses of steroids (\\> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants must have a complete medical history and physical exam within 28 days prior to registration\n* Leukocytes ≥ 3 x 10\\^3/uL (within 28 days prior to registration)\n* Absolute neutrophil count ≥ 1.5 x 10\\^3/uL (within 28 days prior to registration)\n* Platelets ≥ 100 x 10\\^3/uL (within 28 days prior to registration)\n* Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)\n\n  * Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)\n* Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be offered the opportunity to participate in specimen banking\n* Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner MD Anderson Cancer Center","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Hospital in Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Rogers","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tower Cancer Research Foundation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Corona","city":"Corona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Antelope Valley","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute - West Los Angeles Office","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC / Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope South Pasadena","city":"South Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Cancer - Tarzana","city":"Tarzana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Upland","city":"Upland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth - Cherry Creek","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaw Cancer Center","city":"Edwards","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poudre Valley Hospital","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care and Hematology-Fort Collins","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Greeley Hospital","city":"Greeley","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Highlands Ranch Hospital","city":"Highlands Ranch","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCHealth Lone Tree Health Center","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center of the Rockies","city":"Loveland","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Derby Care Center","city":"Derby","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center-Fairfield","city":"Fairfield","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center at Greenwich","city":"Greenwich","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Guilford","city":"Guilford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale-New Haven Hospital North Haven Medical Center","city":"North Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center at Long Ridge","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Torrington Care Center","city":"Torrington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center-Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Waterbury Care Center","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Waterford","city":"Waterford","state":"Connecticut","country":"United 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2: testing Pembrolizumab for Muscle Invasive Bladder Urothelial Carcinoma","inPlainEnglish":"This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor.","whoItsFor":["Ages 18 Years to any","Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)","Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0","NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT","NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)","Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT","Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology","NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (\\> 50%) of the tumor is urothelial cell carcinoma"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography, or Cystoscopy. The registry lists allocation as na. This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 111 people at 182 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.316Z"},{"nctId":"NCT07061977","title":"Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer","officialTitle":"A Phase III Study of Induction Pembrolizumab and Chemotherapy Followed by Chemoradiation and Pembrolizumab vs Chemoradiation and Pembrolizumab Both Followed by Pembrolizumab for High Risk Locally Advanced Cervical Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding induction chemotherapy to the usual treatment of chemotherapy and radiation followed by maintenance may be more effective in treating patients with high risk, locally advanced cervical cancer.","conditions":["Locally Advanced Cervical Adenocarcinoma","Locally Advanced Cervical Adenosquamous Carcinoma","Locally Advanced Cervical Squamous Cell Carcinoma","Stage IIIA Cervical Cancer FIGO 2018","Stage IIIB Cervical Cancer FIGO 2018","Stage IIIC1 Cervical Cancer FIGO 2018","Stage IIIC2 Cervical Cancer FIGO 2018","Stage IVA Cervical Cancer FIGO 2018"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"RADIATION","name":"Brachytherapy"},{"type":"DRUG","name":"Carboplatin"},{"type":"PROCEDURE","name":"Chest Radiography"},{"type":"DRUG","name":"Cisplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"RADIATION","name":"External Beam Radiation Therapy"},{"type":"RADIATION","name":"Intensity-Modulated Radiation Therapy"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Paclitaxel"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"}],"enrollment":336,"startDate":"2025-11-05","completionDate":"2030-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma\n* Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:\n\n  * IIIA (T3aN0M0)\n  * IIIB (T3bN0M0)\n  * IIIC1(T3aN1M0, T3bN1M0)\n  * IIIC2 (T3aN2M0, T3bN2M0)\n  * IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.\n  * NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy.\n\nNo paraaortic lymph node (PALN) metastases above the T12/L1 interspace.\n\n* Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy.\n\nRadiologic definition of lymph node staging:\n\n* N1:\n\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or\n  * One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET\n* N2:\n\n  * One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or\n  * One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET\n\n    * No prior definitive surgical, radiation, or systemic therapy for cervical cancer\n    * No prior immunotherapy\n    * No prior pelvic radiation therapy for any disease\n    * Age ≥ 18\n    * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n    * Not pregnant and not nursing\n    * Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n    * Platelets ≥ 100,000 cells/mm\\^3\n    * Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin \\[Hgb\\] ≥ 8 g/dl is acceptable)\n    * Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula\n    * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n    * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n    * No active infection requiring parenteral antibiotics\n    * No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille Calmette Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed\n    * No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration\n    * No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed\n    * No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n    * No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - 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-pennsylvania","wilkes-barre-pennsylvania","willow-grove-pennsylvania","providence-rhode-island","charleston-south-carolina","gaffney-south-carolina","greer-south-carolina","spartanburg-south-carolina","sioux-falls-south-dakota","dallas-texas","fort-worth-texas","richardson-texas","farmington-utah","salt-lake-city-utah","burlington-vermont","alexandria-virginia","charlottesville-virginia","fairfax-virginia","falls-church-virginia","leesburg-virginia","richmond-virginia","roanoke-virginia","seattle-washington","vancouver-washington","bridgeport-west-virginia","charleston-west-virginia","morgantown-west-virginia","parkersburg-west-virginia","ashland-wisconsin","madison-wisconsin","milwaukee-wisconsin","mukwonago-wisconsin","new-richmond-wisconsin","oconomowoc-wisconsin","superior-wisconsin","waukesha-wisconsin","cheyenne-wyoming","manati-puerto-rico","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 3: testing Carboplatin for Locally Advanced Cervical Adenocarcinoma","inPlainEnglish":"This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds.","whoItsFor":["Ages 18 Years to any","Women only","Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma","Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:","IIIC1(T3aN1M0, T3bN1M0)","IIIC2 (T3aN2M0, T3bN2M0)","IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus","NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy","No paraaortic lymph node (PALN) metastases above the T12/L1 interspace"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Brachytherapy, or Carboplatin. The registry lists allocation as randomized. This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 336 people at 347 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.335Z"},{"nctId":"NCT07062016","title":"Molecular and ctDNA Characterization of High-Risk Endometrial Cancer","officialTitle":"MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This study seeks to better understand the recurrence of high-risk endometrial cancer. It will collect information about cancer genetics to find out various hereditary or cancer specific genetic variants that may have a role in diagnosis or management and prognosis of cancer. It also seeks to develop a genetic results and medical record databank for future studies.","conditions":["Endometrial Carcinoma","Endometrial High Grade Endometrioid Adenocarcinoma","Stage II Endometrial Cancer","Stage III Endometrial Cancer","Stage IV Endometrial Cancer"],"keywords":[],"interventions":[{"type":"OTHER","name":"Non-Interventional Study"}],"enrollment":100,"startDate":"2025-10-01","completionDate":"2028-10-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Planned complete surgical staging at Mayo Clinic. Complete surgical staging includes at least total hysterectomy, bilateral salpingo-oophorectomy and lymph node assessment. Sentinel node mapping meets the criteria for lymph node assessment. Peritoneal cytology is recommended. Additional staging procedures such as pelvic and para-aortic nodal evaluation, omental biopsy or omentectomy, may also be utilized for staging in patients based on the clinical situation and at the surgeon's discretion\n* At least one preoperative or postoperative feature of aggressive disease \\[International Federation of Gynecology and Obstetrics (FIGO) staging used throughout this protocol\\]\n\n  * Preoperatively:\n\n    * Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC\n    * Patients with FIGO grade 1-2 EC with evidence of extrauterine disease on imaging (CT, MRI, or PET)\n  * Postoperatively:\n\n    * Endometrial cancer (FIGO) with one or more established risk factors:\n\n      * Non-endometrioid histology\n\n        * Grade 3\n      * Lymphovascular space invasion (LVSI), ≥ 50% of myometrial invasion, presence of isolated tumor cells (ITC) in a sentinel lymph node OR\n      * Stage II to IV (FIGO) EC\n* Provide written informed consent\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to return to registering site for clinical follow-up\n\nExclusion Criteria:\n\n* Patient receiving or who has received neoadjuvant chemotherapy\n* Pre-operative pregnancy","locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Recurrence-free survival (RFS)","Presence of somatic and germline pathogenic variants"],"hasResults":false,"conditionSlugs":["endometrial-cancer","als"],"drugSlugs":[],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: Non-Interventional Study for Endometrial Carcinoma","inPlainEnglish":"This study seeks to better understand the recurrence of high-risk endometrial cancer. It will collect information about cancer genetics to find out various hereditary or cancer specific genetic variants that may have a role in diagnosis or management and prognosis of cancer.","whoItsFor":["Ages 18 Years to any","Women only","At least one preoperative or postoperative feature of aggressive disease \\[International Federation of Gynecology and Obstetrics (FIGO) staging used throughout this protocol\\]","Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC","Patients with FIGO grade 1-2 EC with evidence of extrauterine disease on imaging (CT, MRI, or PET)","Endometrial cancer (FIGO) with one or more established risk factors:","Non-endometrioid histology","Lymphovascular space invasion (LVSI), ≥ 50% of myometrial invasion, presence of isolated tumor cells (ITC) in a sentinel lymph node OR","Stage II to IV (FIGO) EC"],"whoShouldSkip":["Patient receiving or who has received neoadjuvant chemotherapy","Pre-operative pregnancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Rochester. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.702Z"},{"nctId":"NCT07064473","title":"EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease","officialTitle":"EASi-PROTKT™ - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Type 2 Diabetes, Hypertension and Established Cardiovascular Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.\n\nParticipants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.\n\nParticipants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.","conditions":["Diabetes Mellitus, Type 2","Hypertension","Cardiovascular Diseases"],"keywords":[],"interventions":[{"type":"DRUG","name":"Vicadrostat"},{"type":"DRUG","name":"Empagliflozin"},{"type":"DRUG","name":"Placebo matching Vicadrostat"}],"enrollment":11800,"startDate":"2025-07-22","completionDate":"2029-12-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria :\n\n* At least 18 years old at time of consent\n* Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).\n* Participants with medical history of hypertension and on active pharmacological treatment\n* Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment\n* Established cardiovascular (CV) disease and on active pharmacological treatment\n* At least one additional risk factor for developing heart failure (HF)\n\nExclusion Criteria:\n\n* History of HF or hospitalization for HF or treatment of HF\n* Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)\n* Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)\n* Treatment with an Mineralocorticoid receptor antagonist (MRA)\n* Treatment with amiloride or other potassium-sparing diuretic\n* Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:\n\n  * A direct renin inhibitor (e.g. aliskiren)\n  * More than one Angiotensin-converting enzyme inhibitor (ACEi) and/or Angiotensin receptor blocker (ARB) (including 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3: testing Vicadrostat for Diabetes Mellitus, Type 2","inPlainEnglish":"This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure.","whoItsFor":["Ages 18 Years to any","At least 18 years old at time of consent","Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2)","Participants with medical history of hypertension and on active pharmacological treatment","Participants with medical history of type 2 diabetes mellitus (T2DM) and on active pharmacological treatment","Established cardiovascular (CV) disease and on active pharmacological treatment","At least one additional risk factor for developing heart failure (HF)"],"whoShouldSkip":["History of HF or hospitalization for HF or treatment of HF","Atrial fibrillation or Atrial flutter with a resting heart rate \\>110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)","Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)","Treatment with an Mineralocorticoid receptor antagonist (MRA)","Treatment with amiloride or other potassium-sparing diuretic","Receiving the following treatments at Visit 1 (screening) or requiring such treatment before Visit 2 (randomisation), or planned during the trial:","A direct renin inhibitor (e.g. aliskiren)"],"whatHappens":"If you join, the listed intervention(s) are Vicadrostat, Empagliflozin, or Placebo matching Vicadrostat. The registry lists allocation as randomized. This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 11,800 people at 1137 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.614Z"},{"nctId":"NCT07064759","title":"Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration","officialTitle":"A Phase 3, Randomized, Double-Masked, Active-Controlled Trial of a Single Intravitreal Injection of 4D-150 in Adults With Macular Neovascularization Secondary to Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"4D Molecular Therapeutics","sponsorClass":"INDUSTRY","summary":"This Phase 3 study is evaluating the safety and efficacy of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD). Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.","conditions":["Neovascular Age-Related Macular Degeneration (nAMD)"],"keywords":["Age-related macular degeneration","AMD","Exudative AMD","Neovascular AMD","Exudative age-related macular degeneration","Neovascular age-related macular degeneration","Wet age-related macular degeneration","Wet macular degeneration","Wet AMD","WAMD","nAMD","Retinal gene therapy","Intravitreal gene therapy","Genetic Medicine","Ocular Gene Therapy","Gene Therapy","4FRONT","4FRONT-2"],"interventions":[{"type":"BIOLOGICAL","name":"4D-150 IVT (3E10 vg/eye)"},{"type":"BIOLOGICAL","name":"EYLEA® (aflibercept) Injection 2 mg (0.05mL)"}],"enrollment":480,"startDate":"2025-07-22","completionDate":"2027-11","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥50 years of age at time of consent\n* MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:\n\n  1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR\n  2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator\n* Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center\n* Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center\n* BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit\n* CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center\n\nExclusion Criteria:\n\nOcular Conditions:\n\n* MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)\n* History of retinal detachment in the study eye\n* History of or presence of active inflammation in either eye\n* Glaucoma or intraocular hypertension requiring more than 2 topical medications for control\n\nOcular Treatments/Interventions:\n\n* Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye\n\nSystemic Conditions and Considerations:\n\n* Major illness or major surgical procedure in the 28 days prior to the Screening Visit\n* Uncontrolled blood pressure\n* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit\n* History of autoimmune condition that may predispose to the development of uveitis","locations":[{"facility":"Research Network Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Barnet Dulaney Perkins Eye Center","city":"Sun City","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Retinal Diagnostic Center","city":"Campbell","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Orange County","city":"Fullerton","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Northern California Retina Vitreous Associates","city":"Mountain 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Enrollment in the primary global cohort has been completed; Study centers in Japan remain open for enrollment for the Japan cohort.","whoItsFor":["Ages 50 Years to any","≥50 years of age at time of consent","MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:","Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR","Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center","BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit","CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center"],"whoShouldSkip":["MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter)","History of retinal detachment in the study eye","History of or presence of active inflammation in either eye","Glaucoma or intraocular hypertension requiring more than 2 topical medications for control","Ocular Treatments/Interventions:","Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye","Systemic Conditions and Considerations:"],"whatHappens":"If you join, the listed intervention(s) are 4D-150 IVT (3E10 vg/eye), or EYLEA® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. This Phase 3 study is evaluating the safety and how well it works of 4D-150 versus aflibercept in participants with neovascular age-related macular degeneration (nAMD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 480 people at 126 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.152Z"},{"nctId":"NCT07065214","title":"Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy","officialTitle":"Argon Plasma Treatment for Ovarian Endometrioma Compared to Standard Cystectomy: A Prospective Controlled Randomized Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Erbe Elektromedizin GmbH","sponsorClass":"INDUSTRY","summary":"The study is a prospective, monocentric, randomized controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany.\n\nIn this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment.\n\nSeventy-two (72) patients who meet all eligibility criteria will undergo surgical procedure. The patients will be randomized into the group with standard cystectomy treatment or with APC treatment. Per group n=36 patients will be treated i.e., 1:1 randomization.\n\nA pre-specified primary endpoint analysis is planned after the last patient has undergo Visit 4 (Follow-up after 6 months) to analyze the primary endpoint.\n\nScreening takes place during the first visit (V1). During the second visit (V2) the participants will receive the ovarian endometriosis treatment procedure either with the APC or the standard cystectomy. Standard procedure (standard cystectomy) will be performed for additional endometriosis lesions. The follow up visits (V3 - V5) will take place after three, six and twelve months. Visit 3 and Visit 4 will take place at the study site and AMH will be measured. Whereas Visit 5 will take place via telemedical contact, i.e. phone call.","conditions":["Endometriosis"],"keywords":["ovarian endometriosis"],"interventions":[{"type":"DEVICE","name":"APC"},{"type":"DEVICE","name":"Lap bipolar forceps"}],"enrollment":72,"startDate":"2025-11-26","completionDate":"2028-11-01","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Indication for surgical endometrioma treatment according to patient symptoms\n* Signed informed consent\n\nExclusion Criteria:\n\n* Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial\n* Prior procedures at the ovaries\n* Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)\n* Pregnant or breastfeeding patients\n* Participation in any other clinical study that could affect the AMH level or pregnancy","locations":[{"facility":"Department for Women's Health","city":"Tübingen","state":"Germany","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vanessa Steinmetz","phone":"+49 70717552850","email":"vanessa.steinmetz@erbe-med.com"}],"primaryOutcomes":["Concentration of AMH (Anti-Müller hormone) level"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["t-bingen-germany"],"enrichment":{"headline":"Not a traditional drug phase: APC for Endometriosis","inPlainEnglish":"The study is a prospective, monocentric, randomly assigned controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany. In this Post Market Study it will be determined whether and to what extent the two surgical procedures for ovarian endometrioma treatment (standard cystectomy versus APC) may affect the ovarian reserve by comparing changes in serum AMH levels after treatment.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Indication for surgical endometrioma treatment according to patient symptoms"],"whoShouldSkip":["Expected lack of patient compliance or inability of the patient to understand the purpose of the clinical trial","Prior procedures at the ovaries","Recurrent endometrioma (patients with recurrent endometriosis outside of the ovar, e.g. peritoneal endometriosis lesions can be included)","Pregnant or breastfeeding patients","Participation in any other clinical study that could affect the AMH level or pregnancy"],"whatHappens":"If you join, the listed intervention(s) are APC, or Lap bipolar forceps. The registry lists allocation as randomized. The study is a prospective, monocentric, randomly assigned controlled, two-armed, pilot-study conducted at Department for Women's Health, Tuebingen, Germany.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at Tübingen. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.112Z"},{"nctId":"NCT07065240","title":"A Study to Evaluate the Efficacy and Safety of SPT-300 (GlyphAllo) in Participants With Major Depressive Disorder, With or Without Anxious Distress (BUOY-1 Study)","officialTitle":"A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Seaport Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.","conditions":["Major Depressive Disorder (MDD)","Major Depressive Disorder With Anxious Distress"],"keywords":["Major Depressive Disorder","Depressive Disorder","Depression","Anxiety","Mood Disorders","BUOY-1 Study","SPT-300","LYT-300","GlyphAllo","Glyph Allopregnanolone"],"interventions":[{"type":"DRUG","name":"SPT-300"},{"type":"DRUG","name":"Placebo"}],"enrollment":360,"startDate":"2025-06-19","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.\n* Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.\n* Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.\n* Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.\n* Body mass index (BMI) between 18 to 40 kg/m2, inclusive.\n* Participant is willing and able to refrain from the use of drugs of abuse.\n\nExclusion Criteria:\n\n* History of, or current presentation consistent with:\n\n  1. any depressive episode with psychotic or catatonic features.\n  2. any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.\n  3. bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.\n  4. schizophrenia, schizoaffective, or other psychotic disorder.\n  5. obsessive-compulsive disorder.\n  6. any persistent neurocognitive disorder.\n* History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.\n* Psychiatric hospitalization within current depressive episode.\n* Evidence or history of clinically significant diseases which can affect the patients' participation.\n* Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.\n* Participant has a history of drug or alcohol use disorder.\n* Participants with a positive test for cannabinoids.\n* Clinically significant risk of suicide or harm to self or others.","locations":[{"facility":"Seaport Investigator Site","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Glendale","state":"California","country":"United 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Site","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Leszno","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Pruszków","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Torun","state":"","country":"Poland","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Tuszyn","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Wroclaw","state":"","country":"Poland","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Bratislava","state":"","country":"Slovakia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Rimavská Sobota","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seaport Investigator Site","city":"Vranov nad Topľou","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical trial information desk","phone":"617-807-4062","email":"clinicaltrials@seaporttx.com"}],"primaryOutcomes":["Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["chino-california","garden-grove-california","glendale-california","redlands-california","san-jose-california","cromwell-connecticut","jacksonville-florida","lauderhill-florida","orlando-florida","palm-bay-florida","west-palm-beach-florida","atlanta-georgia","decatur-georgia","marietta-georgia","boston-massachusetts","russells-mills-massachusetts","st-louis-missouri","brooklyn-new-york","cedarhurst-new-york","new-york-new-york","staten-island-new-york","independence-ohio","north-canton-ohio","allentown-pennsylvania","dallas-texas","irving-texas","richardson-texas","everett-washington","lovech-bulgaria","plovdiv-bulgaria","sofia-bulgaria","brno-czechia","pilsen-czechia","prague-czechia","berlin-germany","schwerin-germany","bad-homburg-germany","chemnitz-germany","budapest-hungary","be-chat-w-poland","bialystok-poland","bydgoszcz-poland","gdansk-poland","katowice-poland","leszno-poland","poznan-poland","pruszk-w-poland","torun-poland","tuszyn-poland","warsaw-poland","wroclaw-poland","bratislava-slovakia","rimavsk-sobota-slovakia","vranov-nad-top-ou-slovakia"],"enrichment":{"headline":"Phase 2: testing SPT-300 for Major Depressive Disorder (MDD)","inPlainEnglish":"This is a randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, this drug alone study to measure the how well it works, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (major depression), with or without anxious distress.","whoItsFor":["Ages 18 Years to 65 Years","Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening","Body mass index (body-mass index (BMI)) between 18 to 40 kg/m2, inclusive","Participant is willing and able to refrain from the use of drugs of abuse"],"whoShouldSkip":["History of, or current presentation consistent with:","any depressive episode with psychotic or catatonic features","any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode","bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression","schizophrenia, schizoaffective, or other psychotic disorder","obsessive-compulsive disorder","any persistent neurocognitive disorder"],"whatHappens":"If you join, the listed intervention(s) are SPT-300, or Placebo. The registry lists allocation as randomized. This is a randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, this drug alone study to measure the how well it works, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (major depression), with or without anxious distress.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 360 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.101Z"},{"nctId":"NCT07065552","title":"Tirzepatide in Obesity-Driven Endometrial Cancer","officialTitle":"A Pre-Operative Window Study of Tirzepatide in Obesity-Driven Endometrial Cancer","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"UNC Lineberger Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen.\n\nThe hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.","conditions":["Endometrial Cancer","Obesity"],"keywords":["tirzepatide","tumor microenvironment","insulin","lipid","mTOR signaling"],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":20,"startDate":"2026-04-27","completionDate":"2028-07","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.\n* Agree to comply with all required study assessments and visits including internet capabilities.\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n* Age ≥ 18 at the time of consent.\n* Body mass index of ≥30 kg/m2.\n* Presumed clinically early-stage disease (disease confined to uterus only).\n* ECOG ≤ 2 or Karnofsky Performance Status of \\> 50\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Subject is pregnant or breast feeding.\n* Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.\n* Taking a central nervous system stimulant.\n* Current psychological conditions that would be incompatible with participation in this study, as determined by investigator.\n* Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists.\n* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin.\n* Have a history of severe hypoglycemia or not be able to communicate an understanding of hypoglycemic symptoms.","locations":[{"facility":"Lineberger Comprehensive Cancer Center","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luz Cuaboy","phone":"+1 919-966-4432","email":"luz_cuaboy@med.unc.edu"},{"name":"Emmie Cole","phone":"+1 919-966-4432","email":"emmie_cole@med.unc.edu"}],"primaryOutcomes":["Change in Proliferation"],"hasResults":false,"conditionSlugs":["endometrial-cancer","obesity","hiv"],"drugSlugs":["tirzepatide"],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Early phase 1: testing Tirzepatide for Endometrial Cancer","inPlainEnglish":"LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study.","whoItsFor":["Ages 18 Years to any","Women only","Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging","Agree to comply with all required study assessments and visits including internet capabilities","Age ≥ 18 at the time of consent","Body mass index of ≥30 kg/m2","Presumed clinically early-stage disease (disease confined to uterus only)","ECOG ≤ 2 or Karnofsky Performance Status of \\> 50"],"whoShouldSkip":["Active infection requiring systemic therapy","Subject is pregnant or breast feeding","Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator","Taking a central nervous system stimulant","Current psychological conditions that would be incompatible with participation in this study, as determined by investigator","Known sensitivities (i.e., urticaria and eczema) to GIP and GLP-1 receptor agonists","Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or receiving treatment with insulin"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Chapel Hill. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.035Z"},{"nctId":"NCT07065721","title":"Continuous Glucose Monitoring for Self-Management of Type 2 Diabetes in Young Adults","officialTitle":"CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"San Diego State University","sponsorClass":"OTHER","summary":"Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.","conditions":["Type 2 Diabetes Mellitus (T2DM)"],"keywords":["continuous glucose monitor","type 2 diabetes","young adult"],"interventions":[{"type":"DEVICE","name":"Continuous glucose monitor"}],"enrollment":45,"startDate":"2025-10-02","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* adult 18-45 years of age\n* diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record\n* no prior use or experience with wearable CGMs\n* possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app\n* fluency in English or Spanish\n\nExclusion Criteria:\n\n* severe mental illness (e.g., psychosis, suicidal ideation);\n* pregnancy or \\<6 months postpartum","locations":[{"facility":"Scripps Health","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica L McCurley, PhD, MPH","phone":"619-594-2132","email":"jlmccurley@sdsu.edu"}],"primaryOutcomes":["Qualitative data regarding CGM use"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: Continuous glucose monitor for Type 2 Diabetes Mellitus (T2DM)","inPlainEnglish":"Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.","whoItsFor":["Ages 18 Years to 45 Years","adult 18-45 years of age","diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record","no prior use or experience with wearable CGMs","possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app","fluency in English or Spanish"],"whoShouldSkip":["severe mental illness (e.g., psychosis, suicidal ideation);","pregnancy or \\<6 months postpartum"],"whatHappens":"If you join, the listed intervention(s) are Continuous glucose monitor. The registry lists allocation as na. Type 2 diabetes in increasing common in young adults.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at San Diego. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.522Z"},{"nctId":"NCT07066137","title":"Motor Learning in Health and Movement Disorders: Role of Physical Activity and Advanced Devices","officialTitle":"Motor Planning, Execution, and Modulation in Healthy Individuals and Patients With Movement Disorders or Neuromuscular Diseases Using Traditional Physical Activity or Advanced Devices to Enhance Motor Learning and Sensorimotor Processing","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"IRCCS Centro Neurolesi Bonino Pulejo","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases.\n\nThis study aims to evaluate the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS). It will also assess the impact of proprioceptive stimuli provided by either the immersive virtual reality (CAREN), or visuo-cognitive-motor enhancement (S.V.T.A.), and music therapy.\n\nThe main questions it aims to answer are:\n\nHow do these interventions affect motor activities and their functional recovery? What are the temporal and spatial changes in activation sequences related to motor learning and maintenance? When there is a comparison group: Researchers will compare outcomes between different intervention arms (e.g., physical activity with advanced devices vs. traditional methods) to find out if the advanced interventions result in better motor control and functional recovery.\n\nParticipants will:\n\n* Undergo various rehabilitation protocols including physical activity and advanced interventions.\n* Be assessed using different tool, such as fMRI, dtMRI, and NIRS to study in vivo neuroimaging and assess changes in brain function and connectivity.","conditions":["Healthy Individuals (Controls)","Parkinson Disease","Multiple Sclerosis","Alzheimer Disease","Dementia","Stroke"],"keywords":["Virtual Reality","motor rehabilitation","cognitive rehabilitation","Functional Recovery"],"interventions":[{"type":"DEVICE","name":"CAREN"},{"type":"OTHER","name":"Control group"}],"enrollment":150,"startDate":"2024-05-05","completionDate":"2028-12-06","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20.\n\nExclusion Criteria:\n\n* Severe medical and psychiatric disorders potentially affecting the training","locations":[{"facility":"IRCCS Centro Neurolesi Bonino Pulejo","city":"Messina","state":"Italy/Me","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maria Grazia Maggio, Phd","phone":"+3909061128250","email":"mariagrazia.maggio@irccsme.it"}],"primaryOutcomes":["Amplitude of Motor-Related Event-Related Potentials (ERPs) During Gesture Execution Assessed by EEG."],"hasResults":false,"conditionSlugs":["alzheimer","parkinson","multiple-sclerosis","als","stroke"],"drugSlugs":[],"locationSlugs":["messina-italy"],"enrichment":{"headline":"Not a traditional drug phase: CAREN for Healthy Individuals (Controls)","inPlainEnglish":"The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases. This study aims to measure the effectiveness of traditional physical activities combined with innovative interventions such as cryotherapy, ultrasound therapy, laser therapy, transcranial magnetic stimulation (TMS), and transcranial direct current stimulation (tDCS).","whoItsFor":["Ages 18 Years to 70 Years","Montreal Cognitive Assessment (MoCA) score (adjusted for age and education) equal to or greater than 20"],"whoShouldSkip":["Severe medical and psychiatric disorders potentially affecting the training"],"whatHappens":"If you join, the listed intervention(s) are CAREN, or Control group. The registry lists allocation as randomized. The goal of this clinical trial is to investigate motor responses in healthy subjects and patients with movement disorders, brain and spinal cord injury, neuromuscular diseases, or cardiovascular diseases.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at Messina. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.673Z"},{"nctId":"NCT07066917","title":"Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer","officialTitle":"Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hellenic Cooperative Oncology Group","sponsorClass":"OTHER","summary":"Ample evidence has highlighted the significant clinical benefit of novel therapies for many patients with advanced breast cancer (aBC). The use of CDK inhibitors, antibody-drug conjugates (ADCs), immune checkpoint inhibitors (ICIs), and PARP inhibitors as first-line or subsequent treatments has improved progression-free survival (PFS) rates compared to conventional therapies. In selected cases, these treatments have also increased overall survival (OS), reshaping the therapeutic landscape for advanced breast cancer.\n\nHowever, several key questions remain unanswered. For example, what should be the first-line treatment when multiple effective options are available? Determining the optimal sequence of drugs in successive lines of therapy is another major challenge. Furthermore, the development of resistance to treatment and the occurrence of severe adverse events that may lead to early discontinuation or fatal outcomes are pressing concerns.\n\nThat said, identifying robust predictive biomarkers of response or resistance is crucial for ensuring that patients receive the most effective treatment while avoiding unnecessary exposure to therapies that could cause harm without benefit. Additionally, when multiple effective options exist, selecting the optimal treatment algorithm for each patient based on clinical, pathological, and molecular biomarkers is essential.\n\nWe herein, aim at employing high throughput methodologies, such as Whole Exome Sequencing, circulating tumour DNA (ctDNA) analysis, digital pathology and radiomics analyses, as well as real-world data obtained both from patients records for the training of a ML-based algorithm that can predict response or resistance to a specific treatment, based on the genetic make-up of the patient and the molecular profile of the tumour.","conditions":["Metastatic Breast Cancer"],"keywords":["mBC","biomarkers","ADCs","immunotherapy","PARPi","Breast Cancer"],"interventions":[],"enrollment":150,"startDate":"2024-10-15","completionDate":"2029-10","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eligible patients will be 18 years of age and older\n* Histologically confirmed, advanced breast cancer.\n* Diagnosis of i) hormone receptor positive and/or ii) HER2-positive or -low or iii) triple negative breast cancer (TNBC).\n* Patients will be included in the analysis after receiving at least one treatment cycle.\n\nExclusion Criteria:\n\n* Diagnosis of early breast cancer at time of enrollment\n* Unwillingness to provide informed consent\n* Unwillingness to provide biological specimen\n* Lack of comprehensive clinical data","locations":[{"facility":"University General Hospital \"ATTIKON\", 2nd propedeutic dept. of Internal Medicine","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"\"MITERA\" Hospital, Dept. of Medical Oncology","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolitan Hospital, 2nd Dept. of Medical Oncology","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolitan Hospital, 4th Dept. of Medical Oncology","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's Hospital, Dept. of Medical Oncology","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Electra Sofou, PhD","phone":"+302106912520","email":"e_sofou@hecog.ondsl.gr"},{"name":"Elena Fountzilas, MD, PhD","phone":"+302106912520","email":"elenafou@gmail.com"}],"primaryOutcomes":["Progression-free survival (PFS)","Overall Survival (OS)","Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["athens-greece","thessaloniki-greece"],"enrichment":{"headline":"Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metasta…","inPlainEnglish":"Ample evidence has highlighted the significant clinical benefit of novel therapies for many patients with advanced breast cancer (aBC). The use of CDK inhibitors, antibody-drug conjugates (ADCs), immune checkpoint inhibitors (ICIs), and PARP inhibitors as first-line or subsequent treatments has improved progression-free survival (PFS) rates compared to conventional therapies.","whoItsFor":["Ages 18 Years to any","Women only","Eligible patients will be 18 years of age and older","Histologically confirmed, advanced breast cancer","Diagnosis of i) hormone receptor positive and/or ii) HER2-positive or -low or iii) triple negative breast cancer (TNBC)","Patients will be included in the analysis after receiving at least one treatment cycle"],"whoShouldSkip":["Diagnosis of early breast cancer at time of enrollment","Unwillingness to provide biological specimen","Lack of comprehensive clinical data"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.362Z"},{"nctId":"NCT07067112","title":"Suppressive Functions of Regulatory T Cells in Migraine","officialTitle":"Suppressive Functions of Regulatory T Cells in Migraine","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Clermont-Ferrand","sponsorClass":"OTHER","summary":"Migraine is a frequent, disabling condition, of great social and economical impact worldwide. This condition is more frequent in women and subjects with autoimmune and/or inflammatory diseases. Cytokine and immune cell dysregulations have been evidenced in migraine. Inflammation seems to play an important role in migraine chronification; however, the inflammatory mechanisms involved in migraine pathophysiology remain unclear. Regulatory T (Treg) cells play a central role in maintaining immune homeostasis. They regulate effector T (Teff) cell proliferation and cytokine production, through several suppressive mechanisms, such as the hydrolysis of adenosine triphosphate (ATP) into adenosine (ADO), mediated by surface enzymes Cluster Differentiation 39 (CD39) and Cluster Differentiation 73 (CD73). ATP is involved in pain processes in migraine, and insufficient hydrolysis could participate in pain chronification. Recent studies suggest altered proportions of Treg cells in migraine, and decreased levels of CD39-positive (CD39+) Treg cells, suggesting Treg suppressive functions may be decreased in the disease. However, there have been no functional studies to date to confirm this hypothesis.\n\nThe investigators believe Treg suppressive functions may be decreased in migraine, and that such alterations may be caused by a malfunction in the ADO pathway.","conditions":["Chronic Migraine"],"keywords":["Migraine","Inflammation","Immune system","Regulatory T cells"],"interventions":[{"type":"BIOLOGICAL","name":"Blood sampling, questionnaire and phone call"}],"enrollment":24,"startDate":"2026-09-10","completionDate":"2027-11-30","sex":"FEMALE","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Females\n* 18 to 50 years old\n* For chronic migrain : At least 8 monthly migraine days\n\nExclusion Criteria:\n\n* BMI \\< or = 17kg/m² or \\> or = 30kg/m²\n* Diagnosis or suspicion of type 2 diabetes, auto-immune or inflammatory diseases, immunodeficiency diseases\n* Diagnosis of headache of non-migraine origin, except for tension type headache (i.e.: cluster headache, post-traumatic headache, cerebral tumour…)\n* For controls participants : tension type headache with 4 or more monthly headache days\n* Pregnancy, delivery, miscarriage, breastfeeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \\< 3 months before blood sampling\n* Menopause, hysterectomy, or bilateral oophorectomy\n* Modification of prophylactic anti-migraine therapy (start, change of molecule, interruption) \\< 1 month before blood sampling (for migraine participants)\n* Hormone therapy (beside contraception and treatment of endometriosis)\n* Transplantation (solid organ or bone marrow)\n* Cancer (active or remitting) \\< 1 year before blood sampling (solid organ or blood)\n* Haematologic disease (benign or malignant) of the lymphoid lineage\n* Guardianship, curatorship, safeguard of justice or deprivation of liberty\n* For controls : history of migraine","locations":[{"facility":"CHU Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Laclautre","phone":"334.73.754.963","email":"promo_interne_drci@chu-clermontferrand.fr"}],"primaryOutcomes":["Treg cell suppressive functions"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["clermont-ferrand-france"],"enrichment":{"headline":"Not a traditional drug phase: testing Blood sampling, questionnaire and phone call for Chronic Migraine","inPlainEnglish":"Migraine is a frequent, disabling condition, of great social and economical impact worldwide. This condition is more frequent in women and subjects with autoimmune and/or inflammatory diseases.","whoItsFor":["Ages 18 Years to 50 Years","Women only","For chronic migrain : At least 8 monthly migraine days"],"whoShouldSkip":["body-mass index (BMI) \\< or = 17kg/m² or \\> or = 30kg/m²","Diagnosis or suspicion of type 2 diabetes, auto-immune or inflammatory diseases, immunodeficiency diseases","Diagnosis of headache of non-migraine origin, except for tension type headache (i.e.: cluster headache, post-traumatic headache, cerebral tumour…)","For controls participants : tension type headache with 4 or more monthly headache days","Pregnancy, delivery, miscarriage, breastfeeding, participation in a medically assisted human reproduction program (ovary stimulation/hormone therapy) \\< 3 months before blood sampling","Menopause, hysterectomy, or bilateral oophorectomy","Modification of prophylactic anti-migraine therapy (start, change of molecule, interruption) \\< 1 month before blood sampling (for migraine participants)"],"whatHappens":"If you join, the listed intervention(s) are Blood sampling, questionnaire and phone call. The registry lists allocation as randomized. Migraine is a frequent, disabling condition, of great social and economical impact worldwide.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24 people at Clermont-Ferrand. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.306Z"},{"nctId":"NCT07067463","title":"A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis","officialTitle":"A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Zenas BioPharma (USA), LLC","sponsorClass":"INDUSTRY","summary":"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with PPMS. Patients will be treated for approximately 30 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 705 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.","conditions":["Multiple Sclerosis (MS) Primary Progressive"],"keywords":[],"interventions":[{"type":"DRUG","name":"Orelabrutinib"},{"type":"DRUG","name":"Placebo"}],"enrollment":705,"startDate":"2026-03-23","completionDate":"2030-06","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 to 60 years of age, inclusive\n* Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria\n* Participant must have documented evidence of disability progression observed during the 24 months before screening.\n* Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening.\n\nExclusion Criteria:\n\n* Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)\n* Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy.\n* History or current diagnosis of other neurological disorders that may mimic MS\n* History of any other significant active medical condition\n* History of suicidal behavior within 6 months prior to Screening\n* Any prior history of malignancy if no recurrence within 5 years\n* Patients on anticoagulation, or antiplatelet therapy will be excluded\n* Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducerswithin 14 days\n* Clinically significant laboratory abnormalities at Screening.\n* Any allergy, contraindication, or inability to tolerate orelabrutinib or any of the excipients in the study intervention\n* Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n* History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","locations":[{"facility":"Arizona Neuroscience Research, LLC","city":"Pheonix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perseverance Research Center","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regina Berkovich MD, PhD Inc.","city":"West Hollywood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nova Clinical Research, LLC","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Associates, PA","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurological Services of Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida Department of Neurology - 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Osp.Universitaria Policlinico Federico II Centro Sclerosi Multipla Dip. Scienze Neurologiche","city":"Naples","state":"Naples","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARNAS Ospedali Civico Di Cristina","city":"Palermo","state":"Sicily","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universita degli Studi di Torino - Azienda Ospedaliero-Universitaria San Luigi Gonzaga - Clinica di Malattie dell'Apparato Respiratorio Neurologia & CRESM","city":"Orbassano","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University G. 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Beata Dupejova, neurologická ambulancia S.R.O.","city":"Banská Bystrica","state":"Slovakia","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Alvaro Cunqueiro","city":"Vigo","state":"Galicia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Puerta de Hierro de Majadahonda","city":"Majadahonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Vithas Nisa Sevilla","city":"Castilleja de la Cuesta","state":"Seville","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario A Coruna","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Gregorio Marañon","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regional Municipal Non-commercial Enterprise Chernivtsi Emergency Medical Hospital","city":"Chernivtsi","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNE City Clinical Hospital #1 of Ivano-Frankivsk council","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro Global","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Limited Liability Company Medical Center Neuroclinic","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lviv National Medical University named after Danylo Galytskiy","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Limited Liability Company \"Neurofocus\"","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Clinical Investigational Center of Medical Center LLC Health Clinic","city":"Vinnytsia","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patient and Medical Information","phone":"833-269-4696","email":"clinicaltrialsinfo@zenasbio.com"}],"primaryOutcomes":["Time to onset of composite confirmed disability progression (cCDP) , confirmed over at least 12 weeks (12-week cCDP)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["pheonix-arizona","scottsdale-arizona","west-hollywood-california","bradenton-florida","maitland-florida","orlando-florida","tampa-florida","kansas-city-kansas","roeland-park-kansas","st-louis-missouri","livingston-new-jersey","raleigh-north-carolina","columbus-ohio","greenville-south-carolina","cordova-tennessee","san-antonio-texas","sherman-texas","milwaukee-wisconsin","melbourne-australia","pleven-bulgaria","plovdiv-bulgaria","sofia-bulgaria","veliko-tarnovo-bulgaria","vancouver-canada","zagreb-croatia","choce-czechia","hradec-kr-lov-czechia","teplice-czechia","tallinn-estonia","tbilisi-georgia","bad-homburg-germany","erbach-im-odenwald-germany","pozzilli-italy","naples-italy","palermo-italy","orbassano-italy","chieti-italy","sittard-netherlands","bydgoszcz-poland","lublin-poland","nowa-s-l-poland","zabrze-poland","katowice-poland","plewiska-poland","poznan-poland","gdansk-poland","rzesz-w-poland","szczecin-poland","warsaw-poland","ory-poland","guaynabo-puerto-rico","brasov-romania","constan-a-romania","t-rgu-mure-romania","kragujevac-serbia","belgrade-serbia","ni-serbia","bansk-bystrica-slovakia","vigo-spain","madrid-spain","majadahonda-spain","castilleja-de-la-cuesta-spain","a-coru-a-spain","chernivtsi-ukraine","ivano-frankivsk-ukraine","lviv-ukraine","vinnytsia-ukraine"],"enrichment":{"headline":"Phase 3: testing Orelabrutinib for Multiple Sclerosis (MS) Primary Progressive","inPlainEnglish":"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with PPMS.","whoItsFor":["Ages 18 Years to 60 Years","18 to 60 years of age, inclusive","Diagnosed with Primary Progressive MS (PPMS) according to 2017 McDonald criteria","Participant must have documented evidence of disability progression observed during the 24 months before screening","Expanded disability status scale (EDSS) score between 3.0 to 6.5 points, inclusive, at Screening"],"whoShouldSkip":["Diagnosed with relapsing-remitting MS (RRMS) or secondary progressive MS (SPMS)","Immunologic disorder other than MS or any other conditions requiring oral, intravenous (IV), intramuscular, or intra-articular corticosteroid therapy","History or current diagnosis of other neurological disorders that may mimic MS","History of any other significant active medical condition","History of suicidal behavior within 6 months prior to Screening","Any prior history of malignancy if no recurrence within 5 years","Patients on anticoagulation, or antiplatelet therapy will be excluded"],"whatHappens":"If you join, the listed intervention(s) are Orelabrutinib, or Placebo. The registry lists allocation as randomized. Orelabrutinib is a CNS-penetrable BTK inhibitor.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 705 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.966Z"},{"nctId":"NCT07069712","title":"A Study of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma","officialTitle":"A Master Protocol of an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants With Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.","conditions":["Gastroesophageal Adenocarcinoma"],"keywords":["Locally Advanced Resectable Gastroesophageal Adenocarcinoma","Gastroesophageal Junction","Neoadjuvant Treatment","Perioperative Treatment","Gastric cancer","Immune checkpoint inhibitors","Chemotherapy"],"interventions":[{"type":"DRUG","name":"Sonesitatug Vedotin"},{"type":"DRUG","name":"Rilvegostomig"},{"type":"DRUG","name":"Trastuzumab Deruxtecan (T-DXd)"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"5-Fluorouracil (5-FU)"},{"type":"DRUG","name":"FLOT Chemotherapy"},{"type":"DRUG","name":"Calcium folinate"}],"enrollment":100,"startDate":"2025-07-17","completionDate":"2027-11-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease\n* Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate organ and bone marrow function\n* Body weight \\> 35 kg\n\nExclusion Criteria:\n\n* Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer.\n* Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment\n* Central nervous system (CNS) pathology\n* Uncontrolled infections\n* Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis\n* History of another primary malignancy\n* Participants with any known or suspicious distant metastasis\n* Uncontrolled hepatitis B and/or chronic or active hepatitis B\n* Current or prior use of immunosuppressive medication within 14 days before the first dose of study intervention","locations":[{"facility":"Research Site","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"North Shores","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"New York","state":"New York","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Toronto","state":"Ontario","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research 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Site","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Adapazarı","state":"","country":"Turkey (Türkiye)","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Erzurum","state":"","country":"Turkey (Türkiye)","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Fatih-Istanbul","state":"","country":"Turkey (Türkiye)","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Bristol","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Dundee","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Headington","state":"","country":"United 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(pCR)"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["newark-delaware","washington-d-c-district-of-columbia","fairway-kansas","north-shores-michigan","new-york-new-york","pittsburgh-pennsylvania","toronto-canada","montreal-canada","beijing-china","changchun-china","changzhi-china","chengdu-china","fuzhou-china","hangzhou-china","kunming-china","qingdao-china","shanghai-china","shijiazhuang-china","tbilisi-georgia","florence-italy","milan-italy","modena-italy","pisa-italy","rozzano-italy","udine-italy","vicenza-italy","ch-ku-japan","fukuoka-japan","hidaka-shi-japan","kashiwa-japan","kitaadachi-gun-japan","k-toku-japan","nagoya-japan","osaka-japan","suita-shi-japan","yokohama-japan","bialystok-poland","warsaw-poland","barcelona-spain","elche-spain","madrid-spain","m-laga-spain","ourense-spain","oviedo-spain","santander-spain","valencia-spain","kaohsiung-city-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","adapazar-turkey-t-rkiye","erzurum-turkey-t-rkiye","fatih-istanbul-turkey-t-rkiye","istanbul-turkey-t-rkiye","bristol-united-kingdom","dundee-united-kingdom","headington-united-kingdom","london-united-kingdom","norwich-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Sonesitatug Vedotin for Gastroesophageal Adenocarcinoma","inPlainEnglish":"GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.","whoItsFor":["Ages 18 Years to any","Histologically documented gastric, GEJ, or esophageal adenocarcinoma with resectable disease","Participants who are CLDN18.2-positive in Sub-study 1 or HER2-positive in Sub-study 2; no specific requirements for Sub-study 3","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Adequate organ and bone marrow function","Body weight \\> 35 kg"],"whoShouldSkip":["Participants had any prior anti-cancer treatment or surgery for the current gastric, GEJ, or esophageal cancer","Active or prior documented autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment","Central nervous system (CNS) pathology","Uncontrolled infections","Participants with history of (non-infectious) interstitial lung disease (ILD)/pneumonitis, current ILD/pneumonitis, or suspected ILD/pneumonitis","History of another primary malignancy","Participants with any known or suspicious distant metastasis"],"whatHappens":"If you join, the listed intervention(s) are Sonesitatug Vedotin, Rilvegostomig, or Trastuzumab Deruxtecan (T-DXd). The registry lists allocation as randomized. GEMINI-PeriOp GC study will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of novel agents or novel combinations as perioperative treatment in participants with locally advanced resectable gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma who have not received previous treatment for the disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at 59 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.343Z"},{"nctId":"NCT07069829","title":"Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo","officialTitle":"Real-world, International, Multicentre, Non-interventional, Prospective Cohort to Assess Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo in Routine Care Settings","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death. Recent recommendations from the GOLD report emphasize the diagnosis of COPD and treatment planning based on a combination of lung function metrics, exacerbation history, and patient-reported symptoms. It is recommending the use of triple combination therapy (ICS+LABA+LAMA) such as BREZTRI/TRIXEO as one of the options in Group E patients. While BGF has demonstrated efficacy in controlled clinical trials, real-world evidence is needed to assess its impact on daily patient outcomes and quality of life.\n\nThe iCHOROS study is a real-world, international, multicenter, observational study aiming to evaluate changes in clinical and patient-reported outcomes in adults with moderate to severe COPD treated with BGF for 12 months in routine care settings across Latin America, Asia, and the Middle East \\& Africa. The study will provide valuable insights into the effectiveness and patient experience of BGF therapy in diverse, real-world populations","conditions":["Chronic Obstructive Pulmonary Disease"],"keywords":["COPD","Moderate to Severe Chronic Obstructive Pulmonary Disease","Severe Exacerbations","BGF - Budesonide/Glycopyrrolate/Formoterol Fumarate"],"interventions":[],"enrollment":1400,"startDate":"2025-12-15","completionDate":"2027-12-31","sex":"ALL","minAge":"30 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria:\n\n1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart.\n2. Male or female patients aged over 30 years and under 80 years at the time of enrolment.\n3. Patients providing a written Informed Consent\\* prior to inclusion to the study.\n\n   \\*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study.\n4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be eligible to participate in the study:\n\n1. Patients with COPD due to documented α-1 antitrypsin deficiency.\n2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism).\n3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit.\n4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment.\n5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women.\n6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases.\n7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment.\n8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.","locations":[{"facility":"Research Site","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"La Plata","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mar del Plata","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mendoza","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bogotá","state":"Colombia","country":"Colombia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Medell N","state":"Colombia","country":"Colombia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Barranquilla","state":"","country":"Colombia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rionegro","state":"","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Alexandria","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cairo","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jawa Barat","state":"Indonesia","country":"Indonesia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jakarta","state":"","country":"Indonesia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Amman","state":"","country":"Jordan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"George Town","state":"Malaysia","country":"Malaysia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kuala Selangor","state":"Malaysia","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kuala Lumpur","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kuching","state":"","country":"Malaysia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Malacca","state":"","country":"Malaysia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guadalajara","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mexico City","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Monterrey","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Abhā","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yunlin","state":"Taiwan","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nonthaburi","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Dubai","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hà Nội","state":"Vietnam","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["change from baseline in the COPD Assessment Test"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["buenos-aires-argentina","la-plata-argentina","mar-del-plata-argentina","mendoza-argentina","bogot-colombia","medell-n-colombia","barranquilla-colombia","rionegro-colombia","alexandria-egypt","cairo-egypt","jawa-barat-indonesia","jakarta-indonesia","amman-jordan","george-town-malaysia","kuala-selangor-malaysia","kuala-lumpur-malaysia","kuching-malaysia","malacca-malaysia","guadalajara-mexico","mexico-city-mexico","monterrey-mexico","abh-saudi-arabia","riyadh-saudi-arabia","yunlin-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","bangkok-thailand","nonthaburi-thailand","dubai-united-arab-emirates","h-n-i-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri…","inPlainEnglish":"Chronic Obstructive Pulmonary Disease is a leading cause of global morbidity and mortality, especially in low- and middle-income countries. Exacerbations accelerate disease progression and increase the risk of death.","whoItsFor":["Ages 30 Years to 80 Years","The study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following who can join:","Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart","Male or female patients aged over 30 years and under 80 years at the time of enrolment","Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol"],"whoShouldSkip":["Patients who meet any of the following criteria will not be eligible to participate in the study:","Patients with COPD due to documented α-1 antitrypsin deficiency","Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism)","Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit","Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment","Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women","Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,400 people at 32 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.647Z"},{"nctId":"NCT07071519","title":"A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis","officialTitle":"A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.\n\nRisankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.\n\nParticipants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.","conditions":["Ulcerative Colitis"],"keywords":["risankizumab"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Risankizumab"}],"enrollment":120,"startDate":"2025-07-28","completionDate":"2034-07","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:\n\naminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.\n\n\\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.\n\nExclusion Criteria:\n\n* Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).\n* Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.","locations":[{"facility":"Phoenix Children's Hospital /ID# 273015","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rady Children's Hospital /ID# 271873","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco - Mission Bay /ID# 273022","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nicklaus Children's Hospital - Miami /ID# 271585","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Childrens Center For Digestive Health Care /ID# 273228","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center /ID# 271588","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Goryeb Children's Hospital /ID# 271801","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center /ID# 271831","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Philadelphia /ID# 273222","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Upmc Children'S Hospital Of Pittsburgh /ID# 272328","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Patewood Medical Campus /ID# 272477","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas - Southwestern Medical Center /ID# 271835","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires UCL Saint-Luc /ID# 270123","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universite Enfants Reine Fabiola /ID# 271860","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Regional de la Citadelle /ID# 270459","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Galileo Medical Research /ID# 271817","city":"Juiz de Fora","state":"Minas Gerais","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Pequeno Principe /ID# 271814","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sirio Libanes - Sao Paulo /ID# 271818","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Children's Hospital /ID# 272635","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta Hospital /ID# 271168","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Children's Hospital /ID# 278111","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University - Changchun /ID# 279290","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023","city":"Cottbus","state":"Brandenburg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Kassel /ID# 271546","city":"Kassel","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Muenster /ID# 271898","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thoracic General Hospital of Athens I Sotiria /ID# 270143","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital Attikon /ID# 272361","city":"Chaïdári","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Thessaloniki Hippokrateio /ID# 271939","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889","city":"San Giovanni Rotondo","state":"Foggia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Infantile Burlo Garofolo /ID# 274442","city":"Trieste","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Children's Health And Medical Center /ID# 280462","city":"Ōbu","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tsujinaka Hospital - Kashiwanoha /ID# 280303","city":"Kashiwa-shi","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kurume University Hospital /ID# 280792","city":"Kurume-shi","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gunma University Hospital /ID# 281179","city":"Maebashi","state":"Gunma","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe University Hospital /ID# 281796","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Kumamoto Hospital /ID# 280696","city":"Kumamoto","state":"Kumamoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saga University Hospital /ID# 281232","city":"Saga","state":"Saga-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Children's Medical Center /ID# 280603","city":"Saitama-shi","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamamatsu University Hospital /ID# 281614","city":"Hamamatsu","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital /ID# 280463","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital /ID# 280694","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Children's Medical Center /ID# 280791","city":"Fuchu-shi","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Center For Child Health And Development /ID# 280460","city":"Setagaya City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukushima Medical University Hospital /ID# 281178","city":"Fukushima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdrowia Mdm /ID# 276942","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Network Sp. z o.o. /ID# 276903","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771","city":"Bialystok","state":"Podlaskie Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Children's Hospital /ID# 269960","city":"Belgrade","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696","city":"Belgrade-Vračar","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute for Child and Youth Health Care of Vojvodina /ID# 269961","city":"Novi Sad","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pusan National University Yangsan Hospital /ID# 272769","city":"Yangsan","state":"Gyeongsangnam-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital /ID# 272852","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kangbuk Samsung Hospital /ID# 273333","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Health System - Severance Hospital /ID# 272894","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center /ID# 272862","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Teresa Herrera - CHUAC /ID# 271459","city":"A Coruña","state":"A Coruna","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466","city":"Majadahonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karolinska University Hospital Solna /ID# 271679","city":"Solna","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sodersjukhuset /ID# 271678","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sahlgrenska Universitetssjukhuset /ID# 271675","city":"Gothenburg","state":"Västra Götaland County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital /ID# 269242","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital /ID# 269244","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrookes Hospital /ID# 271489","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital NHS Foundation Trust /ID# 271490","city":"Sheffield","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alder Hey Children's NHS Foundation Trust /ID# 271533","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)","PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)","PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)","PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)","PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)","PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)","Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS","Number of Participants With Adverse Events"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["phoenix-arizona","san-diego-california","san-francisco-california","miami-florida","atlanta-georgia","chicago-illinois","morristown-new-jersey","cleveland-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","greenville-south-carolina","dallas-texas","brussels-belgium","li-ge-belgium","juiz-de-fora-brazil","curitiba-brazil","s-o-paulo-brazil","calgary-canada","edmonton-canada","london-canada","guangzhou-china","zhengzhou-china","changsha-china","changchun-china","shanghai-china","hangzhou-china","cottbus-germany","kassel-germany","m-nster-germany","athens-greece","cha-d-ri-greece","thessaloniki-greece","san-giovanni-rotondo-italy","naples-italy","rome-italy","trieste-italy","bu-japan","kashiwa-shi-japan","kurume-shi-japan","maebashi-japan","kobe-japan","kumamoto-japan","saga-japan","saitama-shi-japan","hamamatsu-japan","bunkyo-ku-japan","fuchu-shi-japan","setagaya-city-japan","fukushima-japan","warsaw-poland","bialystok-poland","belgrade-serbia","belgrade-vra-ar-serbia","novi-sad-serbia","yangsan-south-korea","seoul-south-korea","a-coru-a-spain","majadahonda-spain","solna-sweden","stockholm-sweden","gothenburg-sweden","taichung-taiwan","taipei-taiwan","cambridge-united-kingdom","sheffield-united-kingdom","liverpool-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Risankizumab for Ulcerative Colitis","inPlainEnglish":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC.","whoItsFor":["Ages 2 Years to 17 Years","Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader)","Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:","aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol"],"whoShouldSkip":["Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection)"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 120 people at 73 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.570Z"},{"nctId":"NCT07072624","title":"Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)","officialTitle":"Assessing Phenytoin and Levetiracetam Efficacy, Cost-Effectiveness, and CYP2C9/SV2A Polymorphism in Early Post-Traumatic Seizures: A Multicentric Prospective Randomized Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"All India Institute of Medical Sciences, Jodhpur","sponsorClass":"OTHER_GOV","summary":"Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomized study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the placebo in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.\n\nNovelty: Literature is scarce regarding the ideal management of early PTS in traumatic brain injury (TBI), a major public health problem. Further, no study has evaluated the effect of genetic polymorphism on seizure occurrence in traumatic brain injury. This Multicentric study will be the first of its kind, not only in India but also globally.\n\nObjectives: To evaluate the seizure incidence \\& efficacy of the respective anti-epileptic drug in each treatment arm. Assessment of clinical \\& functional outcomes, safety profile, and cost-effectiveness in each group. Effect of genetic polymorphisms on seizure incidence among study participants Methods: A Multicentric prospective randomized placebo-controlled double-blinded clinical trial is planned. After satisfying eligibility criteria and informed consent, TBI patients will be randomly allocated into three arms 'phenytoin arm', 'levetiracetam arm', and 'placebo'. Drug polymorphism will be analyzed in all the patients using quantitative real-time PCR.\n\nExpected outcome: This study will provide high-quality evidence in PTS management and will establish the role of prophylactic anti-epileptics in PTS. This study also opens the plethora of undesignated roles of genetic polymorphism in the efficacy and safety of levetiracetam and phenytoin in traumatic brain injury patients.","conditions":["Seizures","Traumatic Brain Injuries","Traumatic Brain Injury (TBI) Patients"],"keywords":["Post Traumatic Seizures","Early Post Traumatic Seizures","Traumatic Brain Injury","Seizure Prophylaxis","Antiepileptic drugs","Phenytoin","Levetiracetam","Placebo","Genetic polymorphism","CYP2C9","SV2A","Randomized Controlled Trial","Cost-effectiveness","Multicentric Trial"],"interventions":[{"type":"DRUG","name":"Phenytoin"},{"type":"DRUG","name":"Levetiracetam"},{"type":"DRUG","name":"Placebo"}],"enrollment":1260,"startDate":"2025-07-23","completionDate":"2027-03-15","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients of severe blunt TBI with GCS score less than 10.\n2. Patients with GCS of more than 10 in the presence of computed tomographic imaging findings consistent with brain injury: subarachnoid hemorrhage \\[SAH\\], subdural hematoma \\[SDH\\], epidural hematoma \\[EDH\\], intracerebral hemorrhage \\[ICH\\], or diffuse axonal injury \\[DAI\\], depressed skull fracture.\n3. Patients with penetrating injury.\n\nExclusion Criteria:\n\n1. Females of childbearing age with urine pregnancy test positive.\n2. Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,\n3. Prehospital use of anticonvulsants\n4. Development of seizures before enrolment.","locations":[{"facility":"Postgraduate Institute of Medical Education & Research","city":"Chandigarh","state":"Punjab","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIIMS Jodhpur","city":"Jodhpur","state":"Rajasthan","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanjay Gandhi Postgraduate Institute of Medical Sciences","city":"Lucknow","state":"Uttar Pradesh","country":"India","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr Jaskaran Singh Gosal Associate Professor, MCh Neurosurgery","phone":"91 6283475891","email":"jhsgosal_87@hotmail.com"},{"name":"Dr Shoban Babu Varthya Associate Professor, MD Pharmacology","phone":"91 8437726777","email":"drshobanpgimer@gmail.com"}],"primaryOutcomes":["Number of Participants With Clinical Seizure Within 7 Days Post-Traumatic Brain Injury in each of the three treatment groups."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["chandigarh-india","jodhpur-india","lucknow-india"],"enrichment":{"headline":"Phase 4: testing Phenytoin for Seizures","inPlainEnglish":"Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence. Investigators plan to conduct a high-quality, prospective, multicentric, randomly assigned study regarding seizure prophylaxis in traumatic brain injury (TBI) with phenytoin, levetiracetam, and the dummy treatment (placebo) in three respective treatment groups, along with the effect of drug polymorphism on seizure occurrence.","whoItsFor":["Ages 18 Years to 70 Years","Patients of severe blunt TBI with GCS score less than 10","Patients with penetrating injury"],"whoShouldSkip":["Females of childbearing age with urine pregnancy test positive","Devastating brain injury with expected or confirmed brain death within 48 hours of hospital admission,","Prehospital use of anticonvulsants","Development of seizures before enrolment"],"whatHappens":"If you join, the listed intervention(s) are Phenytoin, Levetiracetam, or Placebo. The registry lists allocation as randomized. Rationale/gaps in existing knowledge: The prophylaxis for post-traumatic seizures (PTS) remains controversial due to a lack of class I evidence.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,260 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.912Z"},{"nctId":"NCT07072728","title":"Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","officialTitle":"A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Psyence Australia Pty Ltd","sponsorClass":"INDUSTRY","summary":"This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.","conditions":["Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer","Cancer Cachexia","Cancer of Endometrium","Cancer of Kidney","Cancer of Prostate","Cancer of the Breast","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas"],"keywords":["Cancer","Adjustment Disorder","Existential Distress","Psilocybin","Psilocin"],"interventions":[{"type":"DRUG","name":"Psilocybin therapy"}],"enrollment":87,"startDate":"2025-10-01","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70/Week 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\< 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and/or myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140/90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90/60 or above 140/90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and/or ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\<60 mL/min (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg/m2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","locations":[{"facility":"Mind Medicine Australia Clinic","city":"Abbotsford","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurocentrix","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramsay Northside Clinic","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Research Melbourne","city":"Northcote","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empax Centre","city":"Leederville","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tim Waugh","phone":"+61481354373","email":"tim@psyencebiomed.com"}],"primaryOutcomes":["Anxiety Severity","Number of participants with treatment-related adverse events as assessed by CTCAE V5.0","Safety and Tolerability of a Single Dose of NPX-5 using the Sheehan Suicide Tracking Scale (S-STS)"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","melanoma","kidney-cancer","stomach-cancer","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["abbotsford-australia","melbourne-australia","northcote-australia","leederville-australia"],"enrichment":{"headline":"Phase 2: testing Psilocybin therapy for Adjustment Disorder","inPlainEnglish":"This study is assessing the how well it works and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis. This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis.","whoItsFor":["Ages 18 Years to 80 Years","To be eligible for study entry participants must satisfy all of the following criteria:","Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer","Screening HAM-A Score ≥18 (moderate anxiety)","Adults aged 18 to 80 years (inclusive) at screening","Diagnosed with cancer (exempting those cancers listed in the"],"whoShouldSkip":[") and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening","Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10","Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff","Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist","Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests","Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet","Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin therapy. The registry lists allocation as randomized. This study is assessing the how well it works and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 87 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.940Z"},{"nctId":"NCT07073079","title":"A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Participants With Crohn's Disease in a Real-World Setting","officialTitle":"Second-line Advanced Therapy in Crohn's Disease: Real-life Effectiveness and Resolution of First-line Suboptimal Control Indicators (CROHNOS - CROHN Therapy Observational Study)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will evaluate the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.\n\nUpadacitinib and risankizumab are approved drugs for treating CD. Approximately 250 participants who are prescribed upadacitinib or risankizumab by their physician in accordance with local label will be enrolled in 25 sites across Italy.\n\nParticipants will receive upadacitinib or risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 18 months.\n\nNo additional burden for participants in this trial is expected.","conditions":["Crohn's Disease"],"keywords":["Crohn's Disease","Upadacitinib","Risankizumab"],"interventions":[],"enrollment":250,"startDate":"2025-07-14","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes\n* Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy\n\nExclusion Criteria:\n\n* Any condition included in the \"warning and precautions\" and \"contraindications\" section of the approved local upadacitinib/risankizumab label\n* Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD","locations":[{"facility":"Ospedale Specializzato In Gastroenterologia Saverio De Bellis /ID# 275706","city":"Castellana Grotte","state":"Bari","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria di Cagliari - P.O. Duilio Casula /ID# 275216","city":"Monserrato","state":"Cagliari","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 275669","city":"San Giovanni Rotondo","state":"Foggia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Clinico Humanitas /ID# 274489","city":"Rozzano","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele /ID# 274458","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 274682","city":"Monza","state":"Monza E Brianza","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II - Naples /ID# 274570","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 274788","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 274461","city":"Turin","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 274654","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Sandro Pertini /ID# 275023","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 274530","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O. Ordine Mauriziano di Torino /ID# 274459","city":"Turin","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale Sacro Cuore Don Calabria /ID# 274462","city":"Negrar","state":"Verona","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.O.U. Consorziale Policlinico di Bari /ID# 274662","city":"Bari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS AOU di Bologna Policlinico Sant Orsola Malpighi /ID# 275161","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera G. Brotzu /ID# 275125","city":"Cagliari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Policlinico G. Rodolico - San Marco /ID# 274909","city":"Catania","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera di Catanzaro Pugliese Ciaccio /ID# 274571","city":"Catanzaro","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Martino /ID# 274529","city":"Genova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 274618","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello /ID# 274964","city":"Palermo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Usl Di Pescara - Presidio Ospedaliero Di Pescara /ID# 274460","city":"Pescara","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Campus Bio-Medico /ID# 274488","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fatebenefratelli Isola Tiberina - Gemelli Isola /ID# 274966","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Caterina Golotta","phone":"+39 06 548891","email":"caterina.golotta@abbvie.com"}],"primaryOutcomes":["Percentage of Participants who Achieve Corticosteroids (CS) Free Remission"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["risankizumab"],"locationSlugs":["castellana-grotte-italy","monserrato-italy","san-giovanni-rotondo-italy","rozzano-italy","milan-italy","monza-italy","naples-italy","turin-italy","rome-italy","negrar-italy","bari-italy","bologna-italy","cagliari-italy","catania-italy","catanzaro-italy","genova-italy","palermo-italy","pescara-italy","roma-italy"],"enrichment":{"headline":"A Study to Assess the Effectiveness of Second-Line Therapy of Upadacitinib and Risankizumab in Adult Partic…","inPlainEnglish":"Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will measure the second line effectiveness of upadacitinib and risankizumab in Crohn's Disease (CD) in a real-world setting.","whoItsFor":["Ages 18 Years to any","Participants with a diagnosis of moderate-to-severe Crohn's Disease (CD) confirmed by clinical, and/or endoscopic/histological indexes","Participants previously treated with Tumor Necrosis Factor inhibitor (TNF-i) as fist line (1L) therapy for at least 6 months; clinical documentation available in medical charts for the previous 2 years or since the beginning of the 1L therapy"],"whoShouldSkip":["Any condition included in the \"warning and precautions\" and \"contraindications\" section of the approved local upadacitinib/risankizumab label","Participants previously exposed to upadacitinib/risankizumab or any approved or investigational non TNFi biologic Disease Modifying Antirheumatic Drug (bDMARDs) for CD"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 250 people at 25 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.582Z"},{"nctId":"NCT07073781","title":"Probiotics, Cognition and Metabolic Health in Young Adults With Overweight or Obesity","officialTitle":"A Double-Blind, Placebo-Controlled Exploratory Trial Of Daily Lab4P Probiotic Supplementation For Cognitive Performance And Metabolic Regulation In Young Adults With Overweight Or Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Leeds Beckett University","sponsorClass":"OTHER","summary":"This 12-week, double-blind, placebo-controlled trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight and obese adults aged 18 to 40. Seventy participants will be randomly assigned to receive either Lab4P or a placebo. The study will assess changes in memory, executive function, and processing speed, along with blood glucose control, cardiovascular function, cholesterol levels, body composition, and markers of inflammation. The study will also analyse changes in the gut microbiome and evaluate the safety and tolerability of the probiotic.","conditions":["Impaired Glucose Tolerance (Prediabetes)","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Overweight (BMI &gt; 25)","Cognitive Dysfunction","Neurovascular Coupling Mechanism and Cognitive Function","Obese Adults"],"keywords":["Probiotic supplementation","Psychobiotic","Cognitive performance","Metabolic function","Impaired glucose tolerance","Gut-brain axis"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Lab4p Probiotic Consortium"},{"type":"OTHER","name":"Placebo"}],"enrollment":70,"startDate":"2025-08-15","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA Written informed consent provided before any study-related procedures. Aged 18-40 years, inclusive, at the time of consent. BMI ≥25.0 kg/m². Self-reported good general health, with no chronic medical conditions requiring ongoing treatment.\n\nSelf-reported normal sleep patterns, with no history of diagnosed sleep disorders.\n\nWilling and able to comply with study procedures, including fasting and oral glucose tolerance testing (OGTT).\n\nNon-smoker at screening, with no regular tobacco use in the preceding six months.\n\nEnglish proficiency equivalent to that of a native speaker.\n\nEXCLUSION CRITERIA Current or past diagnosis of diabetes mellitus of any type. Fasting plasma glucose ≤3.9 or ≥7.0 mmol/L at screening. Diagnosed sleep disorder. History of bariatric surgery or other gastrointestinal procedures that may affect glucose absorption or metabolism.\n\nMajor surgery, significant trauma, systemic infection, or myocardial infarction within six weeks before screening.\n\nHistory of kidney disease, liver disease, low or high blood pressure, or heart disease.\n\nHistory of conditions that may affect food metabolism, including food allergies or gastrointestinal diseases such as irritable bowel syndrome or peptic ulcers.\n\nCurrent or recent use, within four weeks, of medications affecting glucose metabolism or agents that may alter gut microbiota composition or probiotic efficacy, as defined in Section 8.6.\n\nHistory of psychiatric illness, including anxiety or depression. Current use of prescription or over-the-counter medications, excluding hormonal contraception.\n\nNight shift work within 30 days before screening or planned during the study. Pregnancy, breastfeeding, or plans to become pregnant during the study. Known allergy or hypersensitivity to any component of the investigational product or placebo.","locations":[{"facility":"Leeds Beckett University","city":"Leeds","state":"Greater Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lewis F Hepburn","phone":"+447541333140","email":"l.hepburn3449@student.leedsbeckett.ac.uk"}],"primaryOutcomes":["Verbal Memory Performance"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":[],"locationSlugs":["leeds-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Lab4p Probiotic Consortium for Impaired Glucose Tolerance (Prediabetes)","inPlainEnglish":"This 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight and obese adults aged 18 to 40. Seventy you would be randomly assigned to receive either Lab4P or a dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 40 Years","Self-reported normal sleep patterns, with no history of diagnosed sleep disorders","Willing and able to comply with study procedures, including fasting and oral glucose tolerance testing (OGTT)","Non-smoker at screening, with no regular tobacco use in the preceding six months","English proficiency equivalent to that of a native speaker"],"whoShouldSkip":["Current or past diagnosis of diabetes mellitus of any type. Fasting plasma glucose ≤3.9 or ≥7.0 mmol/L at screening. Diagnosed sleep disorder. History of bariatric surgery or other gastrointestinal procedures that may affect glucose absorption or metabolism","Major surgery, significant trauma, systemic infection, or myocardial infarction within six weeks before screening","History of kidney disease, liver disease, low or high blood pressure, or heart disease","History of conditions that may affect food metabolism, including food allergies or gastrointestinal diseases such as irritable bowel syndrome or peptic ulcers","Current or recent use, within four weeks, of medications affecting glucose metabolism or agents that may alter gut microbiota composition or probiotic how well it works, as defined in Section 8.6","History of psychiatric illness, including anxiety or depression. Current use of prescription or over-the-counter medications, excluding hormonal contraception","Night shift work within 30 days before screening or planned during the study. Pregnancy, breastfeeding, or plans to become pregnant during the study. Known allergy or hypersensitivity to any component of the investigational product or dummy treatment (placebo)"],"whatHappens":"If you join, the listed intervention(s) are Lab4p Probiotic Consortium, or Placebo. The registry lists allocation as randomized. This 12-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial will examine whether daily supplementation with the Lab4P probiotic can improve cognitive performance and metabolic health in overweight and obese adults aged 18 to 40.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 70 people at Leeds. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.828Z"},{"nctId":"NCT07073794","title":"Evaluating In Home Cancer Therapy Versus In Clinic Cancer Therapy in Black Men With Locally Advanced, Biochemically Recurrent and Metastatic Prostate Cancer","officialTitle":"A Phase 2 Pragmatic Clinical Trial to Evaluate Administration of Cancer Therapy in the Patients' Homes Versus in Clinic in Black Men With Advanced or Metastatic Prostate Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings. This separation may add to the physical, emotional, social, and financial burden for patients and their families during this difficult time in their lives. Therapy administered to a patient in the patients' residence in the comfort of familiar surrounding using Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) may help reduce psychological and financial distress, increase access to care and improve treatment compliance. Giving cancer therapy in the home compared in the clinic may be safe, tolerable and improve patient satisfaction with overall cancer care in Black men with locally advanced, biochemically recurrent or metastatic prostate cancer.","conditions":["Biochemically Recurrent Prostate Carcinoma","Locally Advanced Prostate Carcinoma","Metastatic Prostate Carcinoma","Stage III Prostate Cancer AJCC v8","Stage IV Prostate Cancer AJCC v8"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cancer Therapeutic Procedure"},{"type":"DRUG","name":"Cancer Therapeutic Procedure"},{"type":"OTHER","name":"Health Care Delivery"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":38,"startDate":"2026-01-22","completionDate":"2028-09-29","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) FDA-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g., NCCN, ASCO, ASH, etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines\n* Black or African American male patients with locally advanced, high risk, biochemical recurrent, or metastatic prostate cancer who are currently receiving or planning to start treatment with one or more of the eligible regimens. Patients may be on any combination of these regimens, provided that at least one is administered by a home health nurse \\[co-administration with second generation antiandrogens, poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, or older antiandrogens are allowed but combinations of oral regimens only are not permitted\\]\n\n  * Androgen deprivation therapy (ADT):\n\n    * Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length\n    * Degarelix SQ, 4 weeks cycle length\n  * Chemotherapy: Cabazitaxel IV, 3 weeks cycle length\n  * Immunotherapy: Pembrolizumab IV, 3 weeks cycle length\n  * Bone modifying agent + any of the prostate cancer treatments:\n\n    * Zoledronic acid IV, 4 or 12 weeks cycle length\n    * Denosumab SQ, 4 or 12 weeks cycle length\n* Patients who are anticipated to continue the treatment regimen they are currently prescribed for at least 18 weeks following registration (if on chemotherapy or immunotherapy) or 24 weeks following registration (for all other treatment regimens)\n* Residing within the area serviced by supplier\n* Provide written informed consent\n* Willing and able to comply with the study protocol in the investigator's judgement\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 for patients on any qualifying treatment (tx) regimen; ECOG PS 0, 1, 2, or 3 for patients on ADT with or without second generation antiandrogen\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Willingness to follow birth control requirements for males of reproductive potential\n\nExclusion Criteria:\n\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Myocardial infarction ≤ 6 months\n  * Wound healing disorder\n  * Or psychiatric illness/social situations that would limit compliance with study requirements\n* Patients with any severe infection within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infections should not be enrolled in the trial (in the current situation, this also applies to patients with suspected or confirmed COVID-19 infection)\n* Anticipation of the need for major surgery during the course of study treatment\n\n  * Note: Concomitant radiation therapy during the study period is allowed\n* Not cleared for treatment in home via social stability screening\n* Patients who received at home treatment through involvement in another CCBW trial\n\n  * Note: Patients who enrolled in another CCBW trial but had to be withdrawn prior to initiating treatment in the home would still be eligible","locations":[{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Patient rating of overall cancer care experience - CAHPS","Patient preferences regarding the location of cancer treatment delivery","Incidence of grade 3+ adverse events (AEs)","Acute care visits, emergency room visits, and hospitalizations","Avoidable acute care visits, emergency room visits and hospitalizations"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["jacksonville-florida"],"enrichment":{"headline":"Phase 2: testing Cancer Therapeutic Procedure for Biochemically Recurrent Prostate Carcinoma","inPlainEnglish":"This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typically drug-related cancer care is conducted at a medical center which causes patients to have to spend considerable time away from family, friends, and familiar surroundings.","whoItsFor":["Ages 18 Years to any","Men only","Androgen deprivation therapy (ADT):","Leuprolide intramuscular (IM) or subcutaneous (SQ), 4 or 12 weeks cycle length","Degarelix SQ, 4 weeks cycle length","Chemotherapy: Cabazitaxel IV, 3 weeks cycle length","Immunotherapy: Pembrolizumab IV, 3 weeks cycle length","Bone modifying agent + any of the prostate cancer treatments:","Zoledronic acid IV, 4 or 12 weeks cycle length"],"whoShouldSkip":["Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm","Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)","Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens","Uncontrolled intercurrent illness including, but not limited to:","Ongoing or active infection","Symptomatic congestive heart failure","Unstable angina pectoris"],"whatHappens":"If you join, the listed intervention(s) are Cancer Therapeutic Procedure, Cancer Therapeutic Procedure, or Health Care Delivery. The registry lists allocation as na. This phase II trial evaluates the impact of cancer therapy in the patients' home compared to in the clinic on safety, side effects, patient preference, and satisfaction in Black men with prostate cancer that has spread to nearby tissue or lymph nodes (locally advanced), that has increasing prostate-specific antigen after treatment (biochemically recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 38 people at Jacksonville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.317Z"},{"nctId":"NCT07074418","title":"Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2","officialTitle":"Effect of Empagliflozin in Patients With eGFR Between 10 and 20 ml/Min/1.73m2 - EMPA [10-20]","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Centre Hospitalier Universitaire de Nice","sponsorClass":"OTHER","summary":"The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.","conditions":["Chronic Kidney Diseases"],"keywords":["Chronic Kidney Disease","Nephrology","eGFR"],"interventions":[{"type":"DRUG","name":"Empagliflozin 10 MG then Placebo"},{"type":"DRUG","name":"Placebo then Empagliflozin 10 MG"}],"enrollment":34,"startDate":"2026-08-25","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* type 2 diabetics,\n* age between 18 and 80 years,\n* RAS blockade at maximal tolerated dosage for 1 month,\n* eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2,\n* UACR \\> 300mg/g creatinine and UPCR \\> 500mg/g creatinine,\n* office systolic blood pressure \\> 110 mmHg,\n* stable dosage of antihypertensive drugs and diuretics for 1 month.\n* for women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed.\n\nExclusion Criteria:\n\n* any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion,\n* history of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs,\n* participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,\n* known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,\n* judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements,\n* no social insurance,\n* unwilling to give informed consent,\n* vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French).","locations":[{"facility":"CHU Nice - Hôpital Pasteur 2","city":"Nice","state":"Alpes-Maritimes","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Guillaume FAVRE, MD-PHD","phone":"492038428","email":"favre.g@chu-nice.fr"}],"primaryOutcomes":["Anti-proteinuric effect"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":["empagliflozin"],"locationSlugs":["nice-france"],"enrichment":{"headline":"Phase 4: testing Empagliflozin 10 MG then Placebo for Chronic Kidney Diseases","inPlainEnglish":"The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure. The investigators therefore hypothesize that SGLT2i should still exert a significant natriuretic effect in patients with eGFR below 20 ml/min/1.73m2, and therefore should still decrease proteinuria with a potential renal protective effect.","whoItsFor":["Ages 18 Years to 80 Years","age between 18 and 80 years,","RAS blockade at maximal tolerated dosage for 1 month,","eGFR (CKD-EPI) between 10 and 20 ml/min/1.73m2,","UACR \\> 300mg/g creatinine and UPCR \\> 500mg/g creatinine,","office systolic blood pressure \\> 110 mmHg,","stable dosage of antihypertensive drugs and diuretics for 1 month","for women of child-bearing age, an effective contraception (estroprogestative pill, contraceptive implant, IUD, condoms or tubal ligation) should be used for more than one month before the inclusion in the study. A urine pregnancy test (βHCG in urines) will be performed"],"whoShouldSkip":["any medical condition that, in the opinion of the investigator makes the participant not suitable for inclusion,","history of ketoacidosis in the past while on empagliflozin or any other SGLT2i class drugs,","participation in another clinical study with an investigational medicinal product (IMP) administered during the month before screening,","known hypersensitivity or intolerance to empagliflozin or any of the excipients of the product,","judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements,","no social insurance,","vulnerable persons (minors, adults under guardianship or trusteeship, pregnant women, persons deprived of their liberty, persons unable to speak French)"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin 10 MG then Placebo, or Placebo then Empagliflozin 10 MG. The registry lists allocation as randomized. The proximal tubule remains the main site for sodium reabsorption in patients with advanced renal failure.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 34 people at Nice. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.617Z"},{"nctId":"NCT07076342","title":"The Role of mGluR5 in CBT-I","officialTitle":"Mechanistic Clinical Trial Evaluating the Role of the Metabotropic Glutamate Receptor Subtype 5 (mGluR5) in the Antidepressant Mechanism of Cognitive Behavioral Therapy for Insomnia (CBT-I)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Stony Brook University","sponsorClass":"OTHER","summary":"This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.","conditions":["Major Depressive Disorder (MDD)"],"keywords":["Cognitive Behavioral Therapy","CBT-I","Cognitive Behavioral Therapy &amp; Insomnia","Major Depressive Disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy for Insomnia"},{"type":"DRUG","name":"PET Scan with [11C]ABP688"}],"enrollment":42,"startDate":"2025-08-01","completionDate":"2030-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* capacity to provide informed consent,\n* at least 18 years of age\n* good physical health and absence of significant medical conditions,\n* diagnosis of major depressive disorder (MDD) with current major depressive episode as per DSM-5 criteria\n* Montgomery-Åsberg Depression Rating Scale (MADRS) score \\> 29 (at least moderate depression),\n* uniform range of sleep latencies up to 128 minutes.\n\nExclusion Criteria:\n\n* currently taking effective antidepressants,\n* lifetime history of psychosis,\n* drug or alcohol dependence in the last 6 months or abuse in the last 2 months\n* unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)\n* nicotine use within 1 year\n* currently on medication known to affect glutamate,\n* sleep disorders, other than insomnia, such as sleep apnea,\n* recent (within 1 year) regular night shift work (or rotating shift work) or recent (within 3 months) travel across more than one time zone, or plans for this work or travel during the study period,\n* use of medication or substances that affect sleep, for example, ingestion of more \\> 600 mg of caffeine per day,\n* PET or MRI contraindications, including pregnancy or currently breastfeeding","locations":[{"facility":"Stony Brook University: Dept of Psychiatry","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wendy Zhang","phone":"(631)-638-2053","email":"Wendy.Zhang@stonybrookmedicine.edu"},{"name":"Christine DeLorenzo, PhD","phone":"(631) 638-1523","email":"christine.delorenzo@stonybrookmedicine.edu"}],"primaryOutcomes":["Change in Sleep Latency from Baseline to 8 Weeks","Change from Baseline of mGluR5 density in the hippocampus after 8 weeks of CBT-I Treatment"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["stony-brook-new-york"],"enrichment":{"headline":"Phase 4: testing PET Scan with [11C]ABP688 for Major Depressive Disorder (MDD)","inPlainEnglish":"This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.","whoItsFor":["Ages 18 Years to any","at least 18 years of age","good physical health and absence of significant medical conditions,","diagnosis of major depressive disorder (major depression) with current major depressive episode as per DSM-5 criteria","Montgomery-Åsberg Depression Rating Scale (MADRS) score \\> 29 (at least moderate depression),","uniform range of sleep latencies up to 128 minutes"],"whoShouldSkip":["currently taking effective antidepressants,","lifetime history of psychosis,","drug or alcohol dependence in the last 6 months or abuse in the last 2 months","unstable medical condition (i.e., condition not adequately stabilized for ≥ 3 months)","nicotine use within 1 year","currently on medication known to affect glutamate,","sleep disorders, other than insomnia, such as sleep apnea,"],"whatHappens":"If you join, the listed intervention(s) are Cognitive Behavioral Therapy for Insomnia, or PET Scan with [11C]ABP688. The registry lists allocation as na. This is mechanistic clinical trial that evaluates the role of one of the glutamate receptors (mGluR5) in cognitive behavioral therapy for insomnia (CBT-I) as a common pathway in improving sleep and depression.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 42 people at Stony Brook. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.099Z"},{"nctId":"NCT07079475","title":"Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)","officialTitle":"A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Dizal Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment","conditions":["Non-Small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"DZD6008"},{"type":"DRUG","name":"Sunvozertinib"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":220,"startDate":"2025-07-30","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants must be able to provide documented informed consent.\n2. Aged ≥ 18 years.\n3. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy.\n4. Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.\n5. Provide adequate baseline tumor and plasma samples. For part A: tumor samples collected after disease progression on the last EGFR TKI treatment. For part B: tumor samples of B1 and B2 cohorts should be collected after disease progression on the last EGFR TKI treatment. Tumor samples of B3 cohort should be collected before the study treatment.\n6. Previous anti-tumor therapy requirement. For part A, B1, and B2 cohorts of part B: participants should have failed (progressed on or are intolerant to) one line of third-generation EGFR TKI regimen (such as Osimertinib), with (cohort B2) or without (cohort B1) prior platinum-based chemotherapy treatment. Participants could receive no more than 2 lines of EGFR TKI treatment and no more than 3 lines of systemic therapy. Participants in B3 cohort: should not receive prior systemic anti-tumor therapy.\n7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.\n8. Brain metastases must be stable at study entry.\n9. Measurable disease per RECIST 1.1.\n10. Adequate hematopoietic and other organ system functions.\n\nExclusion Criteria:\n\n1. NSCLC with mixed small-cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.\n2. For part A: participants only harboring EGFR exon20ins（harboring other EGFR mutations could be enrolled）.\n3. Prior treatment with any of the following: 1) Previously received two or more than two lines of third-generation EGFR TKI treatment. 2) Previously received systemic anti-cancer therapy for advanced disease (only for B3 cohort). 3) Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 4) Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration; 5) Radiotherapy with a limited field of radiation for palliation within 7 days of the first administration, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first administration; 6) Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration; 7) Currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 2 weeks is required prior to the first study drug administration; 8) Currently receiving or unable to stop drugs known to be proton-pump inhibitors. A washout period of at least 1 week is required prior to the first study drug administration; 9) Major surgery within 4 weeks of the first administration of study drug administration or anticipated during the study period.\n4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.\n5. Spinal cord compression or leptomeningeal metastasis.\n6. Participants with any other malignancy within 2 years of the first administration of the study drug.\n7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by the investigator.\n8. Participants with active infection, including but not limited to HBV, HCV and HIV.\n9. Resting QTcF \\> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG; Any factors that increase the risk of QTc prolongation.\n10. Past medical history of ILD or active ILD.\n11. Diseases that would preclude adequate absorption of study drug.\n12. Received a live vaccine within 2 weeks before the first administration of study drug.\n13. Women who are pregnant or breastfeeding.\n14. Hypersensitivity to active or inactive excipients of DZD6008, sunvozertinib or osimertinib (only for B3 cohort).","locations":[{"facility":"Beijing Chest Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Guangzhou Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harbin Cancer Hospital","city":"Harbin","state":"Heilongjiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu People's Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Gulou Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Affilicated Hospital of China Medical University","city":"Shengyang","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shandong Cancer Hospital","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Chest Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Cancer Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Taizhou Hospital","city":"Taizhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"YIFAN LIU","phone":"(86) 021-61095854","email":"yifan.liu@dizalpharma.com"},{"name":"clinicaltrials@dizalpharma.com","phone":"","email":"clinicaltrials@dizalpharma.com"}],"primaryOutcomes":["Part A: To assess safety and tolerability","Part A: To assess safety and tolerability","Part B: To assess anti-tumor activity"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["osimertinib"],"locationSlugs":["beijing-china","guangzhou-china","harbin-china","changsha-china","nanjing-china","shengyang-china","jinan-china","shanghai-china","chengdu-china","tianjin-china","hangzhou-china","taizhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing DZD6008 for Non-Small Cell Lung Cancer","inPlainEnglish":"This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy","Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations","ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks","Brain metastases must be stable at study entry","Measurable disease per RECIST 1.1","Adequate hematopoietic and other organ system functions"],"whoShouldSkip":["NSCLC with mixed small-cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation","For part A: participants only harboring EGFR exon20ins（harboring other EGFR mutations could be enrolled）","Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1","Spinal cord compression or leptomeningeal metastasis","Participants with any other malignancy within 2 years of the first administration of the study drug","Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by the investigator","Participants with active infection, including but not limited to HBV, HCV and HIV"],"whatHappens":"If you join, the listed intervention(s) are DZD6008, Sunvozertinib, or Osimertinib. The registry lists allocation as randomized. This study will treat patients with advanced NSCLC harboring EGFR mutations.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 220 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.678Z"},{"nctId":"NCT07084883","title":"Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration","officialTitle":"Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration in Ophthalmology and Primary Care Settings","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"iHealthScreen Inc","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office. The photos will then be transmitted securely and analyzed by computer in the cloud (telemedicine features). Sufficient accuracy of the automatic system has been established compared to the ophthalmologist's diagnosis. In this study, we aim to validate the system against the prospectively taken OCT image and color fundus images.","conditions":["Age-related Macular Degeneration (AMD)"],"keywords":["Screening","Prediction","age-related macular degeneration","AMD"],"interventions":[{"type":"DEVICE","name":"No intervention."}],"enrollment":1076,"startDate":"2024-08-01","completionDate":"2027-07-31","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects will be recruited if willing and able to comply with clinic visit and study-related procedures, and provide signed informed consent\n\nExclusion Criteria:\n\n* Already diagnosed with AMD, unable to provide informed consent and currently under treatment of retinal disease.","locations":[{"facility":"iHealthScreen Inc.","city":"Richmond Hill","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alauddin Bhuiyan","phone":"718-926-9000","email":"bhuiyan@ihealthscreen.org"},{"name":"Fariha Nuha, BS (Comp. Biology)","phone":"718-912-0837","email":"fariha@ihealthscreen.org"}],"primaryOutcomes":["Referable and non-referable AMD. And Predict the Incidence of AMD in 1 year or 2-year."],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["richmond-hill-new-york"],"enrichment":{"headline":"Not a traditional drug phase: No intervention. for Age-related Macular Degeneration (AMD)","inPlainEnglish":"This study wants to perform a pivotal trial of iPredict, an automated AI-based system for early diagnosis and prediction of late AMD in primary care and ophthalmology settings. Patients will be invited to participate in this study by having non-dilated photos of their eyes taken by an FDA approved fundus camera (DRSPlus from Centervue Inc., CA), at their primary care doctor's office or general ophthalmologist office.","whoItsFor":["Ages 50 Years to any"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,076 people at Richmond Hill. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.139Z"},{"nctId":"NCT07085104","title":"A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease","officialTitle":"A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Allogene Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).","conditions":["Systemic Lupus Erythematosus (With and Without Nephritis)","Idiopathic Inflammatory Myopathy","Systemic Sclerosis"],"keywords":["Systemic lupus erythematosus","SLE","Lupus nephritis","LN","Idiopathic inflammatory myopathy","IIM","Myositis","Dermatomyositis","Anti-synthetase syndrome","Systemic sclerosis","Scleroderma","SSc","Autoimmune disease","CAR T","Allogeneic CAR T","CD19","CD70","AlloCAR T"],"interventions":[{"type":"GENETIC","name":"ALLO-329"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"}],"enrollment":66,"startDate":"2025-11-13","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults ≥ 18 to \\< 75 years of age.\n2. Adequate hematological function and liver, cardiac, and pulmonary function.\n3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later.\n4. Signed and dated informed consent form.\n5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.\n6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing.\n7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months.\n\nExclusion Criteria:\n\n1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.\n2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor.\n3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study.\n4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).\n5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention.\n6. Child-Pugh Class B or C cirrhosis.\n7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing.\n8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment.\n9. Any form of primary, inherited immunodeficiency.\n10. Unwilling to participate in an extended safety monitoring period.\n11. For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and/or interstitial fibrosis.\n12. Participants with IIM: A myositis other than specified classification per exclusion criteria, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody.\n13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.","locations":[{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University Medical Center","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Denver","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute, St. Matthews Campus","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Astera Cancer Care","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Medical College","city":"Valhalla","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Rheumatology-Southpark","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LDS Hospital - lntermountain Health","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Maisonneuve Rosemont","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Allogene Therapeutics, Inc.","phone":"+1 415-604-5696","email":"clinicaltrials@allogene.com"}],"primaryOutcomes":["Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":["car-t"],"locationSlugs":["phoenix-arizona","loma-linda-california","aurora-colorado","jacksonville-florida","chicago-illinois","iowa-city-iowa","kansas-city-kansas","louisville-kentucky","baltimore-maryland","east-brunswick-new-jersey","new-york-new-york","valhalla-new-york","charlotte-north-carolina","durham-north-carolina","charleston-south-carolina","greenville-south-carolina","salt-lake-city-utah","montreal-canada"],"enrichment":{"headline":"Phase 1: testing Cyclophosphamide for Systemic Lupus Erythematosus (With and Without Nephritis)","inPlainEnglish":"This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary how well it works of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to measure the whether it is safe and how hard side effects are to live with of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).","whoItsFor":["Ages 18 Years to 74 Years","Adults ≥ 18 to \\< 75 years of age","Adequate hematological function and liver, cardiac, and pulmonary function","Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures","Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing","Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months"],"whoShouldSkip":["Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection","Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study","Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes)","Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention","Child-Pugh Class B or C cirrhosis","Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing","Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment"],"whatHappens":"If you join, the listed intervention(s) are ALLO-329, Cyclophosphamide, or Fludarabine. The registry lists allocation as randomized. This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary how well it works of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to measure the whether it is safe and how hard side effects are to live with of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 66 people at 18 sites. Taking part typically means taking a study drug (or dummy pill), genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.279Z"},{"nctId":"NCT07086768","title":"Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors","officialTitle":"A Phase Ia/Ib, 2-Part, Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Lei Zheng","sponsorClass":"OTHER","summary":"This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given.\n\nThere will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over time.\n\nIn the second part of the study tow medications will be taken and the dose of the medication may be changed to a higher dose.","conditions":["Solid Tumor","Advanced Solid Tumor","Metastatic Solid Tumor"],"keywords":["anti-SIRPα antibody","anti-signal regulatory protein alpha","Dose Escalation","Dose Expansion"],"interventions":[{"type":"DRUG","name":"BSI-082"},{"type":"OTHER","name":"Trastuzumab deruxtecan"}],"enrollment":57,"startDate":"2026-01-26","completionDate":"2027-08-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Read, understood, and provided written informed consent and must be willing to comply with all study requirements and procedures.\n2. Adults ≥ 18 years of age at the time of informed consent form is signed.\n3. Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have relapsed, or been non-responsive, or have developed disease progression through standard systemic therapy, or have been ineligible for standard systemic therapy known to confer clinical benefit.\n4. Patients having an FDA-approved indication for T-DXd (only for Phase 1b dose expansion).\n5. With 4 weeks or 5 half-lives (whichever is shorter) of prior anticancer therapies (only for Phase 1a dose escalation).\n6. Life expectancy ≥ 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n8. Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per RECISIT V1.1.\n9. Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment.\n10. Main organ functions meet the following criteria:\n\n    * Absolute Neutrophil Count (ANC) ≥ 1.5×109/L\n    * Platelet counts ≥ 100×109/L\n    * Hemoglobin ≥ 9 g/dL (without recent red blood cell transfusion within 2 weeks prior to study entry)\n    * Creatinine clearance ≥ 40 mL/min per the Cockcroft and Gault formula.\n    * AST ≤ 2.5×Upper Limit Normal (ULN or patients with hepatic metastasis ≤ 5×ULN\n    * ALT ≤ 2.5×ULN or patients with hepatic metastasis ≤ 5×ULN\n    * Total Bilirubin ≤ 1.5×ULN, except for patients with Gilbert's syndrome from whom total bilirubin \\< 3.0 × ULN or direct bilirubin \\< 1.5 × ULN\n11. Both male and female of childbearing potential patients enrolled in this trial as well as their partners must agree to use highly effective contraception during the study and for at least 10 months after discontinuing study treatment. Patients and/or partners who are surgically sterile or postmenopausal are exempt from this requirement.\n\nExclusion Criteria:\n\n1. Known allergies, hypersensitivity, or intolerance to monoclonal antibodies (mAbs) or formulation components of BSI-082.\n2. Prior therapy with any SIRPα or CD47 targeting agents.\n3. Has active autoimmune disease or a documented history of autoimmune disease, or history of potential autoimmune syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo, endocrinopathies, type 1 diabetes, or patients with resolved childhood asthma/atopy or other syndromes which would not be expected to recur in the absence of an external trigger (e.g., drug-related serum sickness or post-streptococcal glomerulonephritis). Patients with mild asthma who require intermittent use of bronchodilators (such as albuterol) and those who have not been hospitalized for asthma in the preceding 3 years will not be excluded from this study.\n4. Toxicities of prior anticancer therapies have not resolved to ≤ Grade 1 or to baseline) prior to the first dose of study treatment (excluding alopecia, vitiligo, endocrinopathies on stable hormone replacement therapy, Grade 2 neuropathy from taxanes or platinum containing therapies and Grade 2 hearing loss from platinum-containing therapies).\n5. Has other malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 5 years.\n6. Occurrence of immune related toxicity necessitating permanent discontinuation or immune related toxicity that required treatment with a TNF inhibitor (e.g., infliximab) in patients with previous immunotherapy.\n7. Medical history of myocardial (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV).\n8. Any of the following within 6 months of enrollment: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic events, or pulmonary embolism.\n9. Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms based on average of the screening triplicate 12-lead electrocardiogram (ECG).\n10. Uncontrolled hypertension (resting systolic blood pressure\\>180 mmHg or diastolic blood pressure\\>110 mmHg) and/or severe arrhythmia within 28 days before enrollment.\n11. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.\n12. Has lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder.\n13. Any autoimmune, connective tissue or inflammatory disorders where there is documented or suspicion of pulmonary involvement at the time of screening.\n14. Prior complete pneumonectomy.\n15. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n16. Has uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n17. Has active primary immunodeficiency or active human immunodeficiency virus (HIV) infection as determined by plasma HIV ribonucleic acid (RNA) viral load and CD4 count. For the Dose-expansion phase only, participants with undetectable viral load or normalized CD4 count (CD4+ T-cell counts ≥ 350 cells/μL) and no opportunistic infection within the past 12 months will be eligible. These participants must be on established antiretroviral therapy for at least 4 weeks and have an HIV viral load \\<400 copies/mL prior to enrollment.\n18. Has active hepatitis B or C infection. Participants with past hepatitis C virus (HCV) infection and positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Participants with past or resolved hepatitis B virus infection are eligible only if confirmed by the Investigator.\n19. Has received a live, attenuated vaccine (messenger ribonucleic acid \\[mRNA\\] and replication-deficient adenoviral vaccines are not considered live, attenuated vaccines) within 30 days prior to first exposure to study drug(s).\n20. Has any other acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with trial participation or trial drug administration or could interfere with the interpretation of trial results would make the patient inappropriate for entry into the trial.\n21. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may interfere with the participant's participation in the clinical study or evaluation of the clinical study results.\n22. Women who are pregnant or lactating. All female patients of childbearing potential must have a negative serum pregnancy test prior to the first dose of study treatment.","locations":[{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"John Sarantopoulos, MD","phone":"210 450 5946","email":"sarantopoulo@uthscsa.edu"},{"name":"Epp Goodwin","phone":"210 450 5798","email":"GOODWINE@uthscsa.edu"}],"primaryOutcomes":["Number of Dose limiting toxicity Events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["san-antonio-texas"],"enrichment":{"headline":"Phase 1: testing BSI-082 for Solid Tumor","inPlainEnglish":"This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given.","whoItsFor":["Ages 18 Years to any","Patients having an FDA-approved indication for T-DXd (only for Phase 1b dose expansion)","With 4 weeks or 5 half-lives (whichever is shorter) of prior anticancer therapies (only for Phase 1a dose escalation)","Life expectancy ≥ 12 weeks","Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1","Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per RECISIT V1.1","Has a left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before enrollment","Main organ functions meet the following criteria:"],"whoShouldSkip":["Known allergies, hypersensitivity, or intolerance to monoclonal antibodies (mAbs) or formulation components of BSI-082","Prior therapy with any SIRPα or CD47 targeting agents","Has other malignancy, except for adequately treated basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 5 years","Occurrence of immune related toxicity necessitating permanent discontinuation or immune related toxicity that required treatment with a TNF inhibitor (e.g., infliximab) in patients with previous immunotherapy","Medical history of myocardial (MI) within 6 months before study enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association \\[NYHA\\] Class II to IV)","Any of the following within 6 months of enrollment: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic events, or pulmonary embolism","Has a QT interval corrected with Fridericia's formula (QTcF) prolongation to \\>470 ms based on average of the screening triplicate 12-lead electrocardiogram (ECG)"],"whatHappens":"If you join, the listed intervention(s) are BSI-082, or Trastuzumab deruxtecan. The registry lists allocation as randomized. This is a study that will enroll patients with cancer who have tumors that may have spread.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 57 people at San Antonio. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.361Z"},{"nctId":"NCT07087158","title":"A Study of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","officialTitle":"A Multicenter, Randomized, Open-Label, Active-Controlled Phase II Study Evaluating the Efficacy and Safety of IBR854 Combined With Pazopanib Versus Pazopanib in Advanced Renal Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Imbioray (Hangzhou) Biomedicine Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, open-label, active-controlled Phase II clinical study evaluating the efficacy and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.","conditions":["Renal Cell Carcinoma (RCC)"],"keywords":["IBR854"],"interventions":[{"type":"DRUG","name":"IBR854"},{"type":"DRUG","name":"Pazopanib"}],"enrollment":30,"startDate":"2025-09-08","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female, age ≥ 18 years old\n2. Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery.\n3. Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma.\n4. Expected survival period is at least 3 months.\n5. ECOG performance status of 0 or 1, or KPS score of at least 70.\n6. Has measurable disease per RECIST 1.1.\n7. Organ function should meet the following criteria:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9/L; Platelet (PLT) ≥90×10\\^9/L; Hemoglobin (Hb) ≥ 90 g/L (no blood transfusion or hematopoietic stimulator treatment within 7 days).\n   2. Albumin ≥ 30 g/L; Total bilirubin ≤1.5×ULN (for subjects with Gilbert's syndrome, it can be ≤3×ULN); ALT and AST ≤1.5×ULN (If liver metastasis is combined, ALT and AST≤3×ULN).\n   3. Creatinine (Cr) ≤1.5 × ULN; Creatinine clearance (Ccr) (to be calculated only when Cr \\> 1.5× ULN) \\> 50 ml/min (Cockcroft-Gault formula).\n   4. Activated partial thrombin time (APTT) ≤1.5×ULN, International normalized ratio (INR) ≤1.5×ULN.\n8. Voluntarily sign the informed consent form, understand the study and be willing to follow the protocol and complete all experimental procedures.\n\nExclusion Criteria:\n\n1. Documented central nervous system metastases.\n2. Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment.\n3. Has received major surgery (grade 3 or 4 as defined in the Measures for the Administration of Clinical Application of Medical Technology) within 28 days before the first dose of study treatment and has not yet recovered from which; or any planned curative surgery for renal cell carcinoma during the study.\n4. History of another malignancy within 5 years before the first dose of study treatment, except for Lung carcinoma in situ, low-risk early-stage prostate cancer, or cured basal-cell carcinoma, squamous-cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma.\n5. Clinically significant gastrointestinal abnormalities such as malabsorption syndrome, major gastric or small-bowel resection that may affect drug absorption, active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other conditions increasing the risk of perforation; or history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days before the first dose of study treatment.\n6. Systemic corticosteroids (\\>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:\n\n   1. Topical, intranasal, or inhaled corticosteroids.\n   2. Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging).\n   3. Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency.\n   4. Low-dose corticosteroids for orthostatic hypotension.\n7. Clinically significant cardiovascular or cerebrovascular disease documented by any of the following:\n\n   1. Ischemic stroke (excluding silent lacunar infarction) or severe thromboembolic event within 6 months before the first dose of study treatment.\n   2. Myocardial infarction, unstable angina, congestive heart failure, or clinically significant arrhythmia within 6 months before the first dose of study treatment.\n   3. New York Heart Association (NYHA) class ≥ II heart failure before the first dose of study treatment.\n   4. QTcF interval \\>450 ms (men) or \\>470 ms (women) before the first dose of study treatment.\n   5. Left-ventricular ejection fraction (LVEF) ≤50 % before the first dose of study treatment.\n8. Prior organ transplant, except corneal transplant; prior allogeneic stem-cell transplant.\n9. Hepatitis B surface antigen (HBsAg) positive with HBV DNA \\>500 IU/mL or \\>2,500 copies/mL, or hepatitis C antibody positive with detectable HCV RNA, or known HIV infection, or active tuberculosis.\n10. Interstitial lung disease or non-infectious pneumonitis that is currently symptomatic or has previously required systemic corticosteroids, in the opinion of the investigator likely to interfere with toxicity assessment or management.\n11. Any severe, progressive, or uncontrolled medical condition that, in the investigator's judgment, makes the subject unsuitable for the study, including but not limited to:\n\n    1. Infection requiring systemic therapy.\n    2. Symptomatic pleural, pericardial, or ascitic fluid requiring or having undergone drainage within 2 weeks before the first dose (minimal asymptomatic effusion, third-spacing due to hypoalbuminaemia, or cases where benefit outweighs risk may be allowed).\n    3. History of coagulopathy (e.g., deep-vein thrombosis) or severe bleeding diathesis; clinically significant bleeding event (e.g., gastrointestinal bleeding) within 1 month before the first dose.\n    4. History of severe psychiatric disorder.\n    5. Any other condition that, in the investigator's opinion, renders study participation riskier than beneficial.\n12. Prior grade 3-4 immune-related adverse events that, in the investigator's judgment, should be excluded.\n13. Severe allergic or hypersensitivity disorders, significant drug allergies (including to investigational agents), or known hypersensitivity to any component of the study drug, including severe reactions to monoclonal antibodies.\n14. Participation in another clinical trial and receipt of an investigational agent within 28 days before the first dose of study treatment.\n15. Clinically significant organ dysfunction or comorbidity likely to interfere with protocol adherence.\n16. Live vaccine received within 30 days before the first dose, or planned during the study or within 1 month after the last dose.\n17. Pregnant or breast-feeding women (women who agree to discontinue breast-feeding before signing informed consent may be enrolled).\n18. Any other condition or circumstance that, in the investigator's opinion, unsuitable for participation.","locations":[{"facility":"The Cancer Hospital of Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dingwei Ye, PhD","phone":"+86-13701663571","email":"dwyeli@163.com"}],"primaryOutcomes":["Progression-free Survival (PFS)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing IBR854 for Renal Cell Carcinoma (RCC)","inPlainEnglish":"This is a multicenter, randomly assigned, open-label, active-controlled Phase II clinical study evaluating the how well it works and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.","whoItsFor":["Ages 18 Years to any","Male or female, age ≥ 18 years old","Advanced clear cell renal cell carcinoma confirmed by histology or cytology and not amenable to curative surgery","Has not received any previous systemic anti-tumor treatment for advanced renal cell carcinoma","Expected survival period is at least 3 months","how well you can do daily activities (ECOG score) of 0 or 1, or KPS score of at least 70","Has measurable disease per RECIST 1.1","Organ function should meet the following criteria:"],"whoShouldSkip":["Documented central nervous system metastases","Received prior antineoplastic therapy (including chemotherapy, biologic therapy, immunotherapy, or Chinese traditional medicines with antitumor indications) before the first dose of study treatment","Systemic corticosteroids (\\>10 mg/day prednisone or equivalent) or other immunosuppressive agents required within 2 weeks before the first dose or anticipated during study treatment, except for:","Topical, intranasal, or inhaled corticosteroids","Corticosteroids as premedication for infusion-related or hypersensitivity reactions (e.g., premedication for CT imaging)","Replacement therapy such as levothyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency","Low-dose corticosteroids for orthostatic hypotension"],"whatHappens":"If you join, the listed intervention(s) are IBR854, or Pazopanib. The registry lists allocation as randomized. This is a multicenter, randomly assigned, open-label, active-controlled Phase II clinical study evaluating the how well it works and safety of IBR854 combined with Pazopanib versus Pazopanib in Advanced Renal Cell Carcinoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.908Z"},{"nctId":"NCT07088380","title":"Ketamine Augmentation of ECT in Treatment-Resistant Depression","officialTitle":"The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Università Vita-Salute San Raffaele","sponsorClass":"OTHER","summary":"This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at 4 weeks.","conditions":["Major Depressive Disorder","Treatment Resistant Depression"],"keywords":["ketamine","TRD","depression","electroconvulsive therapy (ECT)"],"interventions":[{"type":"DRUG","name":"Ketamine Hydrochloride"},{"type":"DRUG","name":"Placebo"}],"enrollment":30,"startDate":"2025-07-10","completionDate":"2026-08","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male and female subjects ages 18-70,\n* diagnosed with MDD (according to SCID5-CV interview)\n* treatment resistant (defined as at least 2 different antidepressant agents used without success),\n* ability to give informed consent,\n* adequacy of the score for anesthesia.\n\nExclusion Criteria:\n\n* Chronic neurological diseases,\n* Intellectual disability\n* Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months),\n* Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,\n* Pregnancy and lactation\n* Cardiovascular conditions,\n* Psychiatric Disorders,\n* Hepatic impairment,\n* Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study,\n* Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events.","locations":[{"facility":"IRCCS Ospedale San Raffaele Turro","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alberto AZ Zangrillo, MD","phone":"0226436154","email":"zangrillo.alberto@hsr.it"},{"name":"Cristina CC Colombo, MD","phone":"0226435278","email":"colombo.cristina@hsr.it"}],"primaryOutcomes":["Mean change in depressive symptoms, as measured by MADRS scale"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Phase 3: testing Ketamine Hydrochloride for Major Depressive Disorder","inPlainEnglish":"This is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (major depression). The study aims to determine whether ketamine enhances the antidepressant how well it works of ECT and reduces associated cognitive side effects.","whoItsFor":["Ages 18 Years to 70 Years","Male and female subjects ages 18-70,","diagnosed with major depression (according to SCID5-CV interview)","treatment resistant (defined as at least 2 different antidepressant agents used without success),","adequacy of the score for anesthesia"],"whoShouldSkip":["Chronic neurological diseases,","Intellectual disability","Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year,","Pregnancy and lactation","Cardiovascular conditions,","Psychiatric Disorders,","Hepatic impairment,"],"whatHappens":"If you join, the listed intervention(s) are Ketamine Hydrochloride, or Placebo. The registry lists allocation as randomized. This is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (major depression).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 30 people at Milan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.794Z"},{"nctId":"NCT07090499","title":"A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors","officialTitle":"A Phase 1 Open-label Study to Investigate PF-08046876 in Adult Participants With Advanced Solid Tumors.","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'. ADCs are anticancer drugs designed to stick to cancer cells and kill them.\n\nThe study drug will be given to participants through a needle in a vein (intravenous infusion). This study includes multiple parts. In the first part of the study, there will be different groups of people receiving different doses of the study drug. The study may also test different schedules. In the second part of the study, groups of people will receive the study drug in dosing regimens deemed to be safe in Part 1. In the third part of the study, people will receive the study drug together with other anti-cancer medicines.","conditions":["Advanced/Metastatic Solid Tumors","Bladder Cancer","Urothelial Carcinoma","Advanced Non-Small Cell Lung Cancer","Carcinoma, Non Small Cell Lung","Carcinoma, Squamous Cell of Head and Neck","Head and Neck Cancer","Esophageal Cancer","Gastroesophageal Junction Adenocarcinoma","Esophageal Squamous Cell Carcinoma","Esophageal Adenocarcinoma","Pancreatic Adenocarcinoma","Pancreatic Cancer"],"keywords":["B6C","integrin beta 6","ADC","antibody drug conjugate","bladder cancer","urothelial carcinoma","non-small cell lung cancer","NSCLC","head and neck cancer","HNSCC","SCCHN","esophageal cancer","EC","esophageal squamous cell carcinoma","gastroesophageal junction adenocarcinoma","pancreatic cancer","PDAC","pancreatic adenocarcinoma","esophageal adenocarcinoma","lung adenocarcinoma","lung squamous cell carcinoma","integrin alpha-v beta-6 receptor","ITGB6"],"interventions":[{"type":"DRUG","name":"PF-08046876"},{"type":"COMBINATION_PRODUCT","name":"Pembrolizumab"},{"type":"COMBINATION_PRODUCT","name":"Cisplatin"},{"type":"COMBINATION_PRODUCT","name":"Carboplatin"}],"enrollment":540,"startDate":"2025-08-20","completionDate":"2028-07-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas\n* Measurable disease\n* ECOG Performance status 0-1\n* Part 1: progression or relapse following standard treatments\n* Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting\n* Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group\n* Resolution of acute effects of prior anticancer therapy to baseline or Grade 1\n* Consent to submit required pre-treatment tumor tissue as medically feasible\n\nExclusion criteria:\n\n* Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )\n* Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion\n* Pulmonary disease meeting protocol exclusion\n* Other unacceptable abnormalities as defined by protocol\n* Part 3: Meet contraindications of combination products per protocol and/or local labels","locations":[{"facility":"City of Hope National Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope at Irvine Lennar","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Administrative Address: UCLA Hematology/Oncology","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ronald Reagan UCLA Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Santa Monica UCLA Medical Center & Orthopaedic Hospital","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Hematology/Oncology - Santa Monica","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Yale New Haven Health","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale - New Haven Hospital - Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Phase 1 Unit","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute - Chestnut Hill","city":"Newton","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute - Pharmacy","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center - Conroe","city":"Conroe","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - West Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - League City","city":"League City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - Sugar Land","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pan American Center for Oncology Trials, LLC","city":"Rio Piedras","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"Barcelona [barcelona]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Cancer Centre at St. Bartholomew's Hospital; Queen Mary University of London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Incidence of Treatment Emergent Adverse Events (TEAEs) estimated during the Adverse Events (AE) evaluation","Part 1: Number of Participants With Dose-limiting Toxicities (DLTs): Monotherapy","Part 1: Recommended Monotherapy Dose for Expansion","Part 2: Recommended Monotherapy Phase 2 Dose","Part 3: Recommended Combination Phase 2 Dose/ Recommended Combination Dose for Expansion"],"hasResults":false,"conditionSlugs":["lung-cancer","pancreatic-cancer","bladder-cancer","head-and-neck-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["duarte-california","irvine-california","los-angeles-california","santa-monica-california","new-haven-connecticut","trumbull-connecticut","boston-massachusetts","newton-massachusetts","nashville-tennessee","conroe-texas","houston-texas","league-city-texas","san-antonio-texas","sugar-land-texas","toronto-canada","montreal-canada","changsha-china","rio-piedras-puerto-rico","barcelona-spain","madrid-spain","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 1: testing PF-08046876 for Advanced/Metastatic Solid Tumors","inPlainEnglish":"The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas. PF-08046876 is an investigational anticancer therapy called an 'antibody drug conjugate' or 'ADC'.","whoItsFor":["Ages 18 Years to any","18 years of age or older","Advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas","how well you can do daily activities (ECOG score) 0-1","Part 1: progression or relapse following standard treatments","Part 2: maximum of 2 prior lines of systemic therapy in the advanced setting","Part 3: advanced cancer of the lung or bladder, prior treatment requirements vary by combination therapy group","Resolution of acute effects of prior anticancer therapy to baseline or Grade 1"],"whoShouldSkip":["Received prior treatment with an antibody drug conjugate with a camptothecin-class payload (e.g. sacituzumab govitecan, trastuzumab deruxtecan )","Active anorexia, nausea or vomiting, and/or signs of intestinal obstruction meeting protocol exclusion","Pulmonary disease meeting protocol exclusion","Other unacceptable abnormalities as defined by protocol","Part 3: Meet contraindications of combination products per protocol and/or local labels"],"whatHappens":"If you join, the listed intervention(s) are PF-08046876, Pembrolizumab, or Cisplatin. The registry lists allocation as na. The purpose of the study is to explore the safety and effects of the study drug (PF-08046876) in people diagnosed with advanced cancer of the bladder, lung, head and neck, esophagus, or pancreas.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 540 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.456Z"},{"nctId":"NCT07090668","title":"Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease","officialTitle":"Trans-auricular Nerve Stimulation as an Innovative Approach to the Treatment of Pain in Pediatric Patients Suffering From Sickle Cell Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Emory University","sponsorClass":"OTHER","summary":"The goal of this study is to evaluate the effects of transauricular vagus and trigeminal nerve stimulation on the treatment of pain in children with Sickle Cell Disease.\n\n* The primary objective is to determine the feasibility of using a tAN device to treat pain in pediatric participants with SCD by assessing the completion rate, stimulation tolerability, and acceptability of the intervention measures.\n* The secondary objective is to assess the preliminary efficacy of using a tAN device as a remedy for pain in pediatric SCD subjects by analyzing inflammatory serum biomarker levels, the Functional Status Scale (FSS), the Wong-Baker FACES questionnaire, tracking analgesic consumption, and other assessments.","conditions":["Sickle Cell Disease"],"keywords":["sickle cell disease","pain management in Sickle cell disease","Trans-auricular vagal nerve stimulation","trans-auricular nerve stimulation"],"interventions":[{"type":"DEVICE","name":"tAN device"}],"enrollment":20,"startDate":"2025-08-12","completionDate":"2027-01","sex":"ALL","minAge":"7 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of sickle-cell anemia (HbSS)\n* Normal outer ear anatomy and intact skin for tAN placement\n* Hospitalized for a pain crisis and experiencing pain as a result of SCD\n* Patients must have had at least one prior hospitalization for a sickle cell pain crisis in the past\n\nExclusion Criteria:\n\n* History of seizures\n* History of uncontrolled psychiatric illness\n* Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving\n* Cardiomyopathy\n* Diagnosis of Acute Chest Syndrome\n* Unrepaired congenital anomalies affecting the cardiovascular or respiratory system\n* Hemodynamically unstable patients\n* Females who are pregnant or lactating. Subjects who refuse a pregnancy test.\n* Women of childbearing potential, not using adequate contraception as per the investigator's judgment, or not willing to comply with contraception for the duration of the study\n* Patients with a history of surgery within the last 3 months\n* Patients who suffered from a stroke within the last 3 months\n* Patient admitted with a fever or who develops a fever throughout their hospitalization\n* Patients whose disease-modifying therapy (HU, chronic transfusions, etc.) and/or pain medications (gabapentin, pregabalin, etc.) have not yet reached a steady dose\n* Patients who have had 3 or more hospitalizations for acute pain crises in a given year","locations":[{"facility":"Children's Hospital of Atlanta: Eagelston","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Woodbury, MD","phone":"470-882-8960","email":"awoodbu@emory.edu"},{"name":"Vipin Bansal, MD","phone":"404-630-9552","email":"vbansa7@emory.edu"}],"primaryOutcomes":["Feasibility: Completion Rate","Stimulation tolerability","Acceptability of intervention"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["atlanta-georgia"],"enrichment":{"headline":"Not a traditional drug phase: tAN device for Sickle Cell Disease","inPlainEnglish":"The goal of this study is to measure the effects of transauricular vagus and trigeminal nerve stimulation on the treatment of pain in children with Sickle Cell Disease. * The primary objective is to determine the feasibility of using a tAN device to treat pain in pediatric participants with SCD by assessing the completion rate, stimulation tolerability, and acceptability of the intervention measures.","whoItsFor":["Ages 7 Years to 18 Years","Diagnosis of sickle-cell anemia (HbSS)","Normal outer ear anatomy and intact skin for tAN placement","Hospitalized for a pain crisis and experiencing pain as a result of SCD","Patients must have had at least one prior hospitalization for a sickle cell pain crisis in the past"],"whoShouldSkip":["History of seizures","History of uncontrolled psychiatric illness","Repeated episodes of autonomic instability (apnea or bradycardia) that are not self-resolving","Diagnosis of Acute Chest Syndrome","Unrepaired congenital anomalies affecting the cardiovascular or respiratory system","Hemodynamically unstable patients","Females who are pregnant or lactating. Subjects who refuse a pregnancy test"],"whatHappens":"If you join, the listed intervention(s) are tAN device. The registry lists allocation as randomized. The goal of this study is to measure the effects of transauricular vagus and trigeminal nerve stimulation on the treatment of pain in children with Sickle Cell Disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Atlanta. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.838Z"},{"nctId":"NCT07091630","title":"A Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP","officialTitle":"A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Empasiprubart IV in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"argenx","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to demonstrate the efficacy and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or placebo for 24 weeks (6 months). Following part A, participants will enter part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https://clinicaltrials.argenx.com/emnergize","conditions":["Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","Chronic Inflammatory Demyelinating Polyradiculoneuropathy"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Empasiprubart IV"},{"type":"OTHER","name":"Placebo IV"}],"enrollment":160,"startDate":"2025-09-16","completionDate":"2027-10-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has residual disability and active disease\n* Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)\n* Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP\n\nExclusion Criteria:\n\n* Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)\n* Sensory CIDP (including sensory-predominant CIDP)\n* Polyneuropathy of other causes\n* Clinical diagnosis of systemic lupus erythematosus (SLE)\n* Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation","locations":[{"facility":"University of Alabama at Birmingham - 1720 University Blvd","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner University of Arizona Medical Center","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samir Macwan, M.D., Inc. 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Kukuru a.s. - Pentahospitals","city":"Michalovce","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penta Hospitals SK, a.s. - Rimavská Sobota","city":"Rimavská Sobota","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kent and Canterbury Hospital","city":"Canterbury","state":"Kent","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen's Medical Centre","city":"Nottingham","state":"Nottinghamshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The National Hospital for Neurology and Neurosurgery - PPDS","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Salford Royal Hospital","city":"Salford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sabine Coppieters, MD","phone":"857-350-4834","email":"clinicaltrials@argenx.com"}],"primaryOutcomes":["Reduction of ≥1 point compared with baseline in aINCAT score at week 24"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","tucson-arizona","rancho-mirage-california","colorado-springs-colorado","washington-d-c-district-of-columbia","miami-florida","naples-florida","vero-beach-florida","slidell-louisiana","philadelphia-pennsylvania","knoxville-tennessee","austin-texas","houston-texas","c-rdoba-argentina","rosario-argentina","linz-austria","vienna-austria","salvador-brazil","rio-de-janeiro-brazil","p-rto-alegre-brazil","ribeir-o-preto-brazil","bras-lia-brazil","porto-alegre-brazil","s-o-paulo-brazil","sofia-bulgaria","pleven-bulgaria","fuzhou-china","guangzhou-china","beijing-china","guanzhou-china","suzhou-china","xian-china","medell-n-colombia","barranquilla-colombia","brno-czechia","copenhagen-denmark","tallinn-estonia","lille-france","paris-france","cr-teil-france","bourdeaux-france","nice-france","batumi-georgia","tbilisi-georgia","alexandroupoli-greece","athens-greece","budapest-hungary","hadera-israel","ramat-gan-israel","gussago-italy","trieste-italy","bologna-italy","genova-italy","milan-italy","naples-italy","pavia-italy","bunky-ku-japan","hiroshima-japan","k-riyama-japan","saga-japan","chisinau-moldova","utrecht-netherlands","katowice-poland","krakow-poland","warsaw-poland","brasov-romania","bucharest-romania","campulung-muscel-romania","deva-romania","singapore-singapore","martin-slovakia","michalovce-slovakia","rimavsk-sobota-slovakia","seoul-south-korea","canterbury-united-kingdom","nottingham-united-kingdom","london-united-kingdom","salford-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Empasiprubart IV for Chronic Inflammatory Demyelinating Polyneuropathy","inPlainEnglish":"The main purpose of this study is to demonstrate the how well it works and safety of empasiprubart in adults with CIDP. The study consists of a part A where participants will either receive empasiprubart or dummy treatment (placebo) for 24 weeks (6 months).","whoItsFor":["Ages 18 Years to any","Meets criteria for CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)","Has either typical CIDP or 1 of the following CIDP variants: motor CIDP (including motor-predominant CIDP), multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP","Has residual disability and active disease","Has not received previous treatment for CIDP; or has stopped receiving CIDP treatment; or is receiving CIDP treatment (pulsed or oral corticosteroids, immunoglobulins, PLEX, or FcRn inhibitors)","Participants already receiving CIDP treatment will have to discontinue their CIDP treatment before first IMP administration and must be willing to switch to the study IMP"],"whoShouldSkip":["Meets the criteria for possible CIDP based on EAN/PNS Task Force CIDP guidelines, second revision (2021)","Sensory CIDP (including sensory-predominant CIDP)","Polyneuropathy of other causes","Clinical diagnosis of systemic lupus erythematosus (SLE)","Use of other long-acting immunomodulatory treatment or prior treatment (at any time) with total lymphoid irradiation or bone marrow transplantation"],"whatHappens":"If you join, the listed intervention(s) are Empasiprubart IV, or Placebo IV. The registry lists allocation as randomized. The main purpose of this study is to demonstrate the how well it works and safety of empasiprubart in adults with CIDP.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 160 people at 94 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.931Z"},{"nctId":"NCT07093580","title":"Study of S-892216 Long-acting Injectable (LAI) in Healthy Adult Participants","officialTitle":"Phase 1 Study of a Long-acting Injectable S-892216 in Healthy Adult Participants","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Shionogi","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.","conditions":["Healthy Participants"],"keywords":["First-in-human (FIH)","Long-acting injectable (LAI) formulation","S-892216","S-892216-LAI","Severe acute respiratory syndrome coronavirus 2","SARS-CoV-2 infection","Novel Coronavirus","Coronavirus Disease 2019","COVID-19"],"interventions":[{"type":"DRUG","name":"S-892216-LAI"},{"type":"DRUG","name":"Placebo"}],"enrollment":128,"startDate":"2025-07-29","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Body mass index (BMI) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\\^2)\n\nKey Exclusion Criteria:\n\n* Presence or history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, neurological, or ophthalmological (for example, increased intra-ocular pressure) disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data per the investigator's assessment.\n* History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n* Require medication or other treatment (for example, dietary restrictions or physical therapy).\n* Participated in any other clinical study involving an investigational study intervention or any other type of medical research within 30 days, or 5 times the half-life of the investigational drug, before signing of the informed consent form (ICF) for this study or who are currently participating in such a study.\n* Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody.\n* Positive severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcription polymerase chain reaction (RT-PCR) test result, positive transcription-mediated amplification test result, positive antigen test result, or any other test approved according to local regulations at check in for each period on admission.\n* Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or placebo for S-892216-LAI.\n* Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission.\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Altasciences","city":"Cypress","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Clinical Research: Lenexa","city":"Lenexa","state":"Kansas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"ICON Clinical Research: Salt Lake City","city":"Salt Lake City","state":"Utah","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shionogi Clinical Trials Administrator Clinical Support Help Line","phone":"800-849-9707","email":"Shionogiclintrials-admin@shionogi.co.jp"}],"primaryOutcomes":["Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs)","Part 2: Number of Participants With TEAEs"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["cypress-california","lenexa-kansas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 1: testing S-892216-LAI for Healthy Participants","inPlainEnglish":"This study wants to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.","whoItsFor":["Ages 18 Years to 55 Years","Body mass index (body-mass index (BMI)) ≥18.5 and ≤32.0 kilograms (kg)/square meter (m\\^2)"],"whoShouldSkip":["History of cancer except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years","Require medication or other treatment (for example, dietary restrictions or physical therapy)","Positive test results of the following at screening or within 6 months prior to administration of study intervention: hepatitis B surface antigen (HBsAg); hepatitis C virus antibody (HCV); and human immunodeficiency virus (HIV) antigen/antibody","Known allergy/sensitivity or any hypersensitivity to components of S-892216-LAI or dummy treatment (placebo) for S-892216-LAI","Used cannabis (medical or recreational), tobacco, or nicotine-containing products (including e-cigarettes, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 6 months prior to admission","Note: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are S-892216-LAI, or Placebo. The registry lists allocation as randomized. This study wants to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 128 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.233Z"},{"nctId":"NCT07093814","title":"A Study of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma","officialTitle":"A Phase I/II Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of VRT106 for Injection in Patients With Recurrent/Progressive Glioblastoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Guangzhou Virotech Pharmaceutical Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and efficacy of VRT106 in patients with recurrent/progressive glioblastoma.","conditions":["Glioblastoma"],"keywords":["Glioblastoma"],"interventions":[{"type":"DRUG","name":"VRT106"}],"enrollment":42,"startDate":"2025-09-02","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.\n* Males and females are aged at 18-70 years (including borderline values) at the time of signing the ICF, male or female.\n* Diagnosed with recurrent/progressive glioblastoma.\n* Karnofsky Performance Status (KPS) score ≥60 within 28 days prior to the first administration of the study drug.\n* An expected survival time of≥3 months.\n* Have sufficient organ function.\n* Female patients of childbearing potential must have a negative serum pregnancy test result within 7 days prior to the first use of the study drug (if a false-positive pregnancy test result is due to non-pregnancy factors such as illness, further testing via ultrasound or other methods is required, and the investigator must confirm the absence of pregnancy before enrollment).\n* Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.\n\nExclusion Criteria:\n\n* Patients with extracranial metastases.\n* Previously received treatment with oncolytic viruses, gene therapy.\n* Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of VRT106.\n* Subject is known to have an allergic reaction to any of the components of VRT106.\n* Patients who can't have a cranial MRI scan.\n* Women who are breastfeeding.","locations":[{"facility":"The First Affiliated Hospital of USTC","city":"Hefei","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sanbo Brain Hospital Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Hospital Affiliated to Chongqing University","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanfang Hospital, Southern Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Second People's Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fifth Affiliated Hospital of Sun Yat-sen University","city":"Zhuhai","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangxi Medical University Cancer Hospital","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tangdu Hospital of Air Force Medical University of the PLA","city":"Xi’an","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chengcheng Guo","phone":"020-87343990","email":"guochch@sysucc.org.cn"},{"name":"Ke Sai","phone":"020-87343890","email":"saike@sysucc.org.cn"}],"primaryOutcomes":["Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with recurrent/progressive glioblastoma"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["hefei-china","beijing-china","chongqing-china","guangzhou-china","shenzhen-china","zhuhai-china","nanning-china","jinan-china","xian-china","hangzhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing VRT106 for Glioblastoma","inPlainEnglish":"This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and how well it works of VRT106 in patients with recurrent/progressive glioblastoma.","whoItsFor":["Ages 18 Years to 70 Years","Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures","Males and females are aged at 18-70 years (including borderline values) at the time of signing the ICF, male or female","Diagnosed with recurrent/progressive glioblastoma","Karnofsky Performance Status (KPS) score ≥60 within 28 days prior to the first administration of the study drug","An expected survival time of≥3 months","Have sufficient organ function"],"whoShouldSkip":["Patients with extracranial metastases","Previously received treatment with oncolytic viruses, gene therapy","Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of VRT106","Subject is known to have an allergic reaction to any of the components of VRT106","Patients who can't have a cranial MRI scan","Women who are breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are VRT106. The registry lists allocation as na. This study is an open-label, single-arm Phase I/II clinical trial with the primary objective of evaluating the safety, tolerability, and how well it works of VRT106 in patients with recurrent/progressive glioblastoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 42 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.485Z"},{"nctId":"NCT07095621","title":"Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy","officialTitle":"Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS San Raffaele","sponsorClass":"OTHER","summary":"Background: Enhanced recovery after surgery (ERAS) programs and the minimally invasive approach have significantly improved recovery outcomes following distal pancreatectomy (DP). Nevertheless, most patients stay in the hospital a median of 7 postoperative days after laparoscopic DP, despite achieving functional recovery 3-4 days earlier. Early discharge protocols have proven to be safe and feasible If selected patients.\n\nResearch objectives: This study aims to evaluate the feasibility and effectiveness of a three-day discharge (3DD) protocol for patients undergoing minimally invasive DP.\n\nStudy design: This is an observational, prospective cohort study that will be conducted at San Raffaele Hospital (Milan, Italy) Primary Objective: To investigate the feasibility of a 3-day discharge protocol following a minimally invasive distal pancreatectomy, with post-discharge phone follow-up conducted by a nurse navigator.\n\nSecondary Objective: To investigate the effectiveness of a 3-day discharge protocol following a minimally invasive distal pancreatectomy, evaluate the rate of 30-day emergency departement visits, hospital readmission and patient satisfaction Population: All adult patients undergoing elective minimally invasive distal pancreatectomy who meet the following inclusion criteria will be included in this study\n\n* adult (age\\>= 18 years) patients undergoing elective minimally invasive distal pancreatectomy\n* patients residing or with a temporary accommodation within 50 km or a 30-minute drive from the hospital;\n* patients with an adequate support system at home (defined as 24-hour support for at least the first POD7);\n* no contraindications to intrathecal or opioid-sparing analgesia;\n* patient who have signed the inform consent for participation in the trail;\n* No preoperative medical issue requiring inhospital observation longer than three days Patients scheduled for elective minimally invasive DP, eligible for the study and willing to participate will be asked to sign the consent form in person during the preoperative counseling session.\n\nParticipants will receive comprehensive preoperative education and will be enrolled in an ERAS protocol that includes urinary catheter removal, initiation of a solid food diet, cessation of intravenous infusions, and oral pain management starting on postoperative day (POD 1). Following discharge on POD3, patients will receive a daily telephonic follow-up by a nurse navigator for the first 7 days after surgery (POD 7).\n\nPreoperatively: patients will complete in person during the counseling visit Patient-Reported Outcomes Measurement Information System (PROMIS)-29 questionnaire and patient-activation measure (PAM) - 13 questionnaires.\n\nAt discharge: patients will complete in person in the department PROMIS-29 questionnaire.\n\nAt 30 days after surgery, patients satisfaction will be assessed Duration of subject participation: 6 months Duration of total study period: 18 months","conditions":["Pancreatic Neoplasms","Distal Pancreatectomy (DP)"],"keywords":["pancreatic disease","early discharge"],"interventions":[{"type":"PROCEDURE","name":"3 days discharge"}],"enrollment":35,"startDate":"2025-09-13","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* adult (age\\>= 18 years) patients undergoing elective minimally invasive distal pancreatectomy\n* patients residing or with a temporary accommodation within 50 km or a 30-minute drive from the hospital;\n* patients with an adequate support system at home (defined as 24-hour support for at least the first POD7);\n* no contraindications to intrathecal or opioid-sparing analgesia;\n* patient who have signed the inform consent for participation in the trail;\n* No preoperative medical issue requiring inhospital observation longer than three days\n\nExclusion Criteria:\n\n* Patients undergoing multi-visceral resection;\n* undergoing an open procedure;\n* requiring vascular resection;\n* having a history of chronic opioid use;\n* having significant comorbidities or an American Society of Anesthesiologists (ASA) score \\> 3;\n* patients unabled to speak Italian;\n* having a cognitive impairment;\n* develoing intraoperative complications;\n* difficulty to be reached after discharge (e.g., limited access to a telephone).","locations":[{"facility":"IRCCS Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicolò Pecorelli, MD","phone":"+39 0226436046","email":"pecorelli.nicolo@hsr.it"}],"primaryOutcomes":["Percentage of patients without any Emergency Department (ED) visits within POD7"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: 3 days discharge for Pancreatic Neoplasms","inPlainEnglish":"Background: Enhanced recovery after surgery (ERAS) programs and the minimally invasive approach have significantly improved recovery outcomes following distal pancreatectomy (DP). Nevertheless, most patients stay in the hospital a median of 7 postoperative days after laparoscopic DP, despite achieving functional recovery 3-4 days earlier.","whoItsFor":["Ages 18 Years to any","adult (age\\>= 18 years) patients undergoing elective minimally invasive distal pancreatectomy","patients residing or with a temporary accommodation within 50 km or a 30-minute drive from the hospital;","patients with an adequate support system at home (defined as 24-hour support for at least the first POD7);","no contraindications to intrathecal or opioid-sparing analgesia;","patient who have signed the inform consent for participation in the trail;","No preoperative medical issue requiring inhospital observation longer than three days"],"whoShouldSkip":["Patients undergoing multi-visceral resection;","undergoing an open procedure;","requiring vascular resection;","having a history of chronic opioid use;","having significant comorbidities or an American Society of Anesthesiologists (ASA) score \\> 3;","patients unabled to speak Italian;","having a cognitive impairment;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 35 people at Milan. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.467Z"},{"nctId":"NCT07099053","title":"PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)","officialTitle":"PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute on Aging (NIA)","sponsorClass":"NIH","summary":"Background:\n\nSome people experience cognitive decline as they age. That is, they lose memory, problem-solving, and other mental abilities. Amyloids are groups of proteins that develop in the brain and increase in number as people age. Researchers want to use imaging scans to track amyloids in people s brains over time. Their goal is to find out if any changes are related to cognitive decline or other medical issues.\n\nObjective:\n\nTo learn how amyloids may affect brain structure and function as people age.\n\nEligibility:\n\nPeople aged 55 years and older who are enrolled in the Baltimore Longitudinal Study of Aging.\n\nDesign:\n\nParticipants will have imaging scans and other tests every 1 to 4 years, depending on their age. Those 80 and older will be scanned yearly. These scans will be done during regular BLSA visits.\n\nThe scans will be positron emission tomography and computed tomography (PET CT). Participants will be given fluid through a tube inserted into a vein in their arm. The fluid is a tracer that will cause the amyloids to light up in the images. Then they will lie on a bed with their head inside a PET CT scanner. They will lie still for about 30 minutes.\n\nParticipants will have tests to assess their memory and other mental skills. They will answer questions about their mood and daily life. These tests will take about 40 minutes to complete; they may be done in person or by phone.\n\nParticipants will give a contact number for someone who can answer questions about the participant s daily routine. These questions may be answered in person or by phone.\n\nParticipants will be in this study for 5 years.","conditions":["Aging"],"keywords":["Amyloid","PET"],"interventions":[],"enrollment":400,"startDate":"2026-11-15","completionDate":"2029-12-12","sex":"ALL","minAge":"55 Years","maxAge":"110 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION/EXCLUSION CRITERIA:\n* Participants are men and women 55 years and older drawn from the BLSA sample and thus, represent the gender/ethnic characteristics of this study group. Enrollment is defined as the initial imaging session of the planned longitudinal study.\n* Inclusion criteria. BLSA participants who do not meet exclusion criteria and have had or agreed to have an MRI under the BLSA study.\n* Participants who lack capacity to consent will not be enrolled in the study. If the participant loses capacity to consent over the course of follow-up they will be removed from the study. Competency to consent is assessed as part of the BLSA visit and we will not include people who are not competent to provide consent.\n\nEXCLUSION CRITERIA:\n\n* Preexisting central nervous system diseases\n* Weight over 300 lbs.\n* Active metastatic cancer (except basal cell cancer)\n* Implanted electronic hearing devices\n* Breast Cancer with radiation treatment\n* Lymphoma\n* Pacemaker\n* Brain tumor\n* Shrapnel\n* Schizophrenia\n* Bipolar disorder\n* Epilepsy\n* Language barrier that makes it difficult to understand participant.\n* Aneurisms greater than 3mm\n* Aneurysm clips\n* Parkinson s disease/PD medications\n* Huntington s disease\n* Severe Endocrinopathy- treated thyroid conditions ok; treated, controlled diabetes ok. (exclude HbA1c over 8 which is poorly controlled diabetes)\n* Diagnosis of dementia or mild cognitive impairment\n* Younger than 55 years of age\n* Pregnancy\n* Ineligible for MRI\n* History of stroke or documented TIAs requiring hospitalization\n* Known brain vascular malformations or adenomas\n* History of significant radiation exposure\n* Those with a Blessed score of 4 or more with the BLSA will be reviewed at a research diagnostic case conference to rule out dementia diagnoses prior to enrollment.\n* Participants undergoing chronic treatment with a CYP1A2 inducer will be ineligible for Tauklarify PET, but this does not constitute an exclusion criterion for Neuraceq PET.","locations":[{"facility":"National Institute of Aging, Clinical Research Unit","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wendy D Elkins","phone":"(410) 558-8610","email":"wendy.elkins@nih.gov"},{"name":"Luigi Ferrucci, M.D.","phone":"(410) 558-8110","email":"ferruccilu@grc.nia.nih.gov"}],"primaryOutcomes":["Amyloid accumulation"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)","inPlainEnglish":"Background: Some people experience cognitive decline as they age. That is, they lose memory, problem-solving, and other mental abilities.","whoItsFor":["Ages 55 Years to 110 Years"],"whoShouldSkip":["Participants are men and women 55 years and older drawn from the BLSA sample and thus, represent the gender/ethnic characteristics of this study group. Enrollment is defined as the initial imaging session of the planned longitudinal study","who can join. BLSA participants who do not meet"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.318Z"},{"nctId":"NCT07099898","title":"A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]","officialTitle":"Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving Ris-Rez and the other receiving topotecan.","conditions":["Neoplasms, Lung"],"keywords":["Risvutatug Rezetecan","Ris-Rez","Topotecan","Small Cell Lung Cancer (SCLC)","EMBOLD SCLC-301"],"interventions":[{"type":"BIOLOGICAL","name":"Risvutatug rezetecan (Ris-Rez)"},{"type":"DRUG","name":"Topotecan"}],"enrollment":420,"startDate":"2025-08-11","completionDate":"2027-11-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Adults \\>18 or the minimum legal adult age at the time the informed consent form is signed\n* Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC).\n* Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor for at least 2 cycles of therapy and a chemotherapy free-interval of \\>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible.\n* Has at least 1 target lesion per RECIST 1.1, as determined by the investigator.\n* Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has adequate organ function and an ECOG performance status of 0 or 1\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Pathological diagnosis of complex SCLC or transformed SCLC.\n* Limited stage small cell lung cancer at diagnosis\n* Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has severe, 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Blood tests will be performed to check how much LY4256984 gets into the bloodstream and how long it takes the body to eliminate it.","conditions":["ALS (Amyotrophic Lateral Sclerosis)"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4256984"},{"type":"DRUG","name":"Placebo"}],"enrollment":36,"startDate":"2025-08-05","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateral sclerosis (ALS) made by a physician experienced with the management of ALS\n* ALS symptom onset as determined by the Investigator within 24 months of Screening\n* Have a body mass index (BMI) within the range of greater than or equal to 18.0 and less than or equal to 35.0 kilogram per square meter (kg/m²) (inclusive)\n\nExclusion Criteria:\n\n* Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality\n* Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems\n* Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal.\n* Have a significant renal impairment (estimated glomerular filtration rate \\<60 milliliters per minute \\[mL/min\\]/1.73 m²).\n* Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion of the investigator, that increases the risks associated with participating in the study\n* Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)","locations":[{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heritage Medical Research Clinic","city":"Calgary","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Walter Mackenzie Health Sciences Centre","city":"Edmonton","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre","city":"London","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Neurological Institute and Hospital","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Research Institute","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein","city":"Lübeck","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration \"Albrecht Kossel\" Klinik und Poliklinik für Neurologie","city":"Rostock","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Bellvitge","city":"L'Hospitalet de Llobregat","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari i Politecnic La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["leuven-belgium","calgary-canada","edmonton-canada","london-canada","montreal-canada","toronto-canada","l-beck-germany","rostock-germany","ulm-germany","utrecht-netherlands","lhospitalet-de-llobregat-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing LY4256984 for ALS (Amyotrophic Lateral Sclerosis)","inPlainEnglish":"This study wants to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral sclerosis (ALS). The study drug will be administered intrathecally (IT) into the spine.","whoItsFor":["Ages 18 Years to 75 Years","Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateral sclerosis (ALS) made by a physician experienced with the management of ALS","ALS symptom onset as determined by the Investigator within 24 months of Screening","Have a body mass index (body-mass index (BMI)) within the range of greater than or equal to 18.0 and less than or equal to 35.0 kilogram per square meter (kg/m²) (inclusive)"],"whoShouldSkip":["Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality","Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems","Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal","Have a significant renal impairment (estimated glomerular filtration rate \\<60 milliliters per minute \\[mL/min\\]/1.73 m²)","Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion of the investigator, that increases the risks associated with participating in the study","Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)"],"whatHappens":"If you join, the listed intervention(s) are LY4256984, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral sclerosis (ALS).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.972Z"},{"nctId":"NCT07101107","title":"Socio-cognitive and Biological Responses to Maltreatment","officialTitle":"Socio-cognitive and Biological Responses to Childhood Maltreatment in Individuals With Bipolar Disorder and Control Subjects","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Medical University Innsbruck","sponsorClass":"OTHER","summary":"The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism. However, it is unclear how a history of emotional CM affects psychological and biological outcomes in bipolar disorder (BD). Therefore, this study focuses on understanding how a possible history of CM affects BD compared to control participants (CP) with no known psychiatric illness.\n\nThe aim of the project is to investigate how a history of emotional CM is associated with social cognition. The investigators will recruit 80 CP and 80 people diagnosed with BD, some of whom will have a history of CM. The investigators will assess psychological well-being (social behaviour, empathy) at two points in time at the Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology at the Medical University of Innsbruck (MUI). Additionally, as they want to understand how emotional CM affects brain function and structure, the investigators will perform magnetic resonance imaging (MRI) of the brain at the Neuroimaging Core Facility (Medical University of Innsbruck). The investigators also want to understand how biological markers in the blood (such as telomere length, inflammation) might be affected, assessed in collaboration with the Department of Psychology (Leopold-Franzens University of Innsbruck). Finally, the investigators will look at a combination of the psychological and biological tests to see if there is a link between emotional CM and health outcomes.","conditions":["Bipolar 1 Disorder","Control Subjects"],"keywords":["childhood maltreatment","Social Cognition","empathy","Bipolar Disorder","Biomolecules","Magnetic Resonance Imaging","Theory Of Mind","telomere length","mitochondria","benevolent childhood experiences","trauma","positive childhood experiences","inflammatory markers"],"interventions":[],"enrollment":160,"startDate":"2026-07-20","completionDate":"2030-02-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria for individuals diagnosed with bipolar disorder (BD):\n\n* diagnosis of a moderate to severe depressive episode without psychotic features in the context of BD-I according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5: 296.52 BD-I, most recent episode depressed, moderate; 296.53 BD-I, most recent episode depressed, severe without psychotic features;\n* Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20;\n* age between 18 and 65 years; and\n* able to provide written informed consent for magnetic resonance imaging (MRI) and study participation.\n\nExclusion Criteria for individuals diagnosed with BD:\n\n* a history of one or more diagnoses of the following DSM-5 categories: past or current moderate or severe substance dependence (303.x, 304.x, 305.x) with the exclusion of tobacco use disorder (305.1), neurodevelopmental disorders (299.x, 307.x, 314.x, 315.x, 319.x), schizophrenia spectrum and other psychotic disorders (293.x, 295.x, 297.x, 298.x), neurocognitive disorders (290.x, 292.x, 294.x, 331.x), BD-I Single Manic (296.0x), BD-I Manic (296.4x), BD-I Mixed (296.6, 296.7, 296.8, 296.9), BD-II (296.89), or comorbid Borderline Personality Disorder (BPD) as assessed by Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD);\n* a current episode of illness with psychotic features (296.54);\n* a recent history of central nervous system (CNS) trauma or significant CNS trauma;\n* physical illness that might interfere with the participant's cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol derivates;\n* cardiovascular impairment with life-threatening issues;\n* electroconvulsive therapy in the last 12 months;\n* current substance abuse (except caffeine and nicotine) as assessed by DSM-5 or positive urine drug screen;\n* IQ≤70 as assessed by the Mehrfachwahl-Wortschatztest\" version B (MWT-B);\n* MRI contraindications (e.g. claustrophobia, metal, electric, magnetic or mechanically driven implants); or\n* other ethical considerations (e.g. pregnancy, lactation, participants not fluent in the language of the cognitive batteries and questionnaires).\n\nInclusion Criteria for healthy volunteers:\n\n* absence of any axis I disorder according to DSM-5 and physical illness that might interfere with participant's cognitive performance;\n* age between 18 and 65 years according to clinical group; and\n* ability to give written informed consent for MRI and study participation.\n\nExclusion Criteria for healthy volunteers:\n\n* first degree relatives with BD, schizophrenia, or known genetically-based mitochondriopathies;\n* a history of any axis I disorder, neurological, developmental disorders, CNS trauma, or comorbid BPD.\n* physical illness that might interfere with the participants' cognitive performance;\n* an autoimmune disorder or inflammatory diseases;\n* currently on anti-inflammatory drugs, cortisol or cortisol-derivates;\n* cardiovascular impairments with life-threatening issues;\n* current substance abuse;\n* IQ≤70;\n* MRI contraindications; or\n* other ethical considerations.","locations":[{"facility":"Medical University of Innsbruck","city":"Innsbruck","state":"Tyrol","country":"Austria","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Noora Tuovinen, PhD","phone":"+4351250483819","email":"noora.tuovinen@i-med.ac.at"}],"primaryOutcomes":["Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure; MACE-X) and emotion recognition of adult faces (Reading the Mind in the Eyes Test; RMET)","Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and emotion recognition of child faces (Reading the Mind in the Eyes Test; RME-C-T)","Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and cognitive empathy (Multifaceted Empathy Test; MET-core 2)","Correlation between a history of emotional childhood maltreatment score (Maltreatment and Abuse Chronology of Exposure scale; MACE-X) and affective empathy (Multifaceted Empathy Test; MET-core 2)"],"hasResults":false,"conditionSlugs":["als","bipolar-disorder","schizophrenia"],"drugSlugs":[],"locationSlugs":["innsbruck-austria"],"enrichment":{"headline":"Socio-cognitive and Biological Responses to Maltreatment","inPlainEnglish":"The study will investigate how a history of emotional childhood maltreatment (CM) is associated with different aspects of psychological (social behaviour, empathy) and biological (brain function and structure, inflammation) health. In fact, CM is a risk factor for many mental disorders, such as schizophrenia and autism.","whoItsFor":["Ages 18 Years to 65 Years","for individuals diagnosed with bipolar disorder (BD):","Montgomery-Åsberg Depression Rating Scale (MADRS) score≥20;","age between 18 and 65 years; and"],"whoShouldSkip":["for individuals diagnosed with BD:","a current episode of illness with psychotic features (296.54);","a recent history of central nervous system (CNS) trauma or significant CNS trauma;","physical illness that might interfere with the participant's cognitive performance;","an autoimmune disorder or inflammatory diseases;","currently on anti-inflammatory drugs, cortisol or cortisol derivates;","cardiovascular impairment with life-threatening issues;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 160 people at Innsbruck. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.745Z"},{"nctId":"NCT07102368","title":"A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","officialTitle":"Generation of Real-world Evidence of Guselkumab in IBD Evaluating Effectiveness, Early Outcomes and Patient Relevant Aspects","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen-Cilag G.m.b.H","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.","conditions":["Inflammatory Bowel Disease","Colitis, Ulcerative","Crohn's Disease"],"keywords":["IBD","Ulcerative Colitis","Crohn's Disease","Gastroenteritis","Gastrointestinal Diseases","Digestive System Diseases","Colonic Diseases","Intestinal Diseases","Pathologic Processes","Inflammatory Bowel Diseases","Colitis, Ulcerative","Ulcer","Guselkumab","Tremfya","Inflammatory"],"interventions":[],"enrollment":500,"startDate":"2025-08-18","completionDate":"2029-01-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics\n2. Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements\n3. By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study\n\nExclusion Criteria:\n\n1. Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy\n2. Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included\n3. Has had a colectomy and/or a pouch\n4. Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson \\& Johnson (J\\&J)","locations":[{"facility":"Praxis Fur Gastroenteroligie","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)","Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["berlin-germany"],"enrichment":{"headline":"A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany","inPlainEnglish":"This study wants to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.","whoItsFor":["Ages 18 Years to any","Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics","By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study"],"whoShouldSkip":["Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy","Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included","Has had a colectomy and/or a pouch","Is currently enrolled in an treatment clinical study or another non-treatment study from Janssen or Johnson \\& Johnson (J\\&J)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Berlin. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.894Z"},{"nctId":"NCT07104916","title":"Mindfulness-based Psilocybin Therapy for PTSD","officialTitle":"A Pilot Mechanistic RCT of Psilocybin With Mindfulness-based Therapy vs Support for Posttraumatic Stress Disorder (PTSD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Anthony P King","sponsorClass":"OTHER","summary":"The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomized, controlled study in participants with PTSD. The study will investigate the changes in brain activity, connectivity, and microstructural neuroplasticity assessed using EEG/EMG and multimodal MRI measures after administration of one oral dose of psilocybin, accompanied either with standard \"psychological support\" only; or with standard support plus Mindfulness-based Cognitive Therapy (MBCT).","conditions":["Post Traumatic Stress Disorder","Depression - Major Depressive Disorder"],"keywords":["Psychedelic","functional MRI","Mindfulness-based Cognitive Therapy","Psilocybin","microstructural neuroplasticity"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Psilocybin + MBCT therapy"},{"type":"COMBINATION_PRODUCT","name":"Active Comparator: Psilocybin with Support Only"}],"enrollment":30,"startDate":"2026-09-01","completionDate":"2029-09","sex":"ALL","minAge":"21 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nParticipants meeting the following criteria will be included in the study:\n\n1. Participant is assigned female or male at birth.\n2. Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age / developmental factors in persons under 21 and over 65.\n3. Participant has a BMI of 18 to 30 kg/m2, inclusive, at Screening.\n4. Participant has a diagnosis of PTSD (as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition \\[DSM-5\\] established through a clinician interview that includes the Mini-International Neuropsychiatric Interview \\[MINI\\]) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).\n5. PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20.\n6. Participants capable of producing sperm must use a condom during the trial and for 3 months after their dose of trial medication, if their partner is a person of childbearing potential. In addition, their partner of childbearing potential must also use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) from dosing until 3 months following dosing. Condoms alone and abstinence are not considered highly effective methods of contraception.\n7. Participants of childbearing potential must agree to use a highly effective method of contraception (i.e., failure rate less than 1% when used consistently and correctly) in combination with use of a condom by a partner who is capable of producing sperm, during the trial and for 3 months after dosing. Condoms alone and abstinence are not considered highly effective methods of contraception. Such participants must have a negative pregnancy test at Screening and Day 1.\n8. Participants of non-childbearing potential who are or were capable of producing eggs (ova) must be postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Postmenopausal is defined as spontaneous amenorrhea for at least 12 months, and a serum follicle stimulating hormone (FSH) level in the menopausal range, unless the participant is taking hormone replacement therapy or is using hormonal contraception.\n9. Provision of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nIf appropriate, describe why certain populations may be excluded (e.g., non-English speaking individuals for studies involving informed consent).\n\nExclusion Criteria\n\nParticipants with the following will be excluded from study participation:\n\n1. Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement.\n2. Current or previously diagnosis of schizophrenia spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder or brief psychotic disorder; current or previous history of bipolar disorder, or current personality disorder (as determined by MINI at Screening). This is an FDA requirement.\n3. Clinically significant risk of suicidality, as determined through a comprehensive psychiatric interview that incorporates the Columbia Suicide Severity Rating Scale (CSSRS); a score of 4 or higher on the suicidal ideation subscale of C-SSRS (past 6 months) or any suicidal behaviour (lifetime), would be exclusionary.\n4. History of substance use disorder within the 12 months, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview \\[MINI\\], Version 7.0.2) or determined by self-report, or intake of \\>21 units of alcohol weekly, and the inability to refrain from alcohol use from 48 hours before Screening and each scheduled visit until discharge from the study site. One unit is equivalent to a 285 mL glass of full-strength beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.\n5. Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer.\n6. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening.\n7. Use of psychotropic medicine/supplement (or medicine/supplement that would interact with psilocybin) including buspirone and venlafaxine, during the 28 days before dosing. Participants may take a stable chronic dose of other SSRI antidepressant medication(s) and/or sedatives/hypnotics. The Investigator and study team may review medication on a case-by-case basis to determine if its use would compromise participant safety or interfere with study procedures or data interpretation.\n8. Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives).\n9. Clinically relevant history of abnormal physical health interfering with the study as determined by medical history and physical examinations obtained during Screening as judged by the Investigator (including \\[but not limited to\\], neurological, endocrine, cardiovascular, respiratory, gastrointestinal (including dyspepsia or gastroesophageal reflux disease), hepatic, or renal disorder).\n10. Participant has a presence or relevant history of any of the following medical conditions: organic brain disorders (e.g., epilepsy, seizure, intracranial hypertension, intracranial bleed and aneurysmal disease, brain tumor or other medical conditions associated with seizures or convulsions).\n11. Diagnosis of hypertension or arrhythmia.\n12. Clinically relevant abnormal heart rate (resting supine heart rate \\>100 bpm) or blood pressure (resting supine systolic blood pressure (SBP) above 140 mmHg or diastolic blood pressure (DBP) above 90 mmHg) at screening. Screening supine SBP, DBP and heart rate for evaluation will be the average of 3 readings obtained after at least 5 minutes rest. Participants with abnormal vital signs which are out of range and deemed clinically significant by the Investigator at Day 1, following triplicate readings.\n13. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement.\n14. QT interval corrected for heart rate using Fridericia's formula (QTcF) \\>450 msec at Screening, following triplicate ECG readings.\n15. Hypothyroidism and/or current abnormal thyroid function tests. In case of uncertain or questionable screening thyroid function test results, the TSH test may be repeated once during screening. The TSH test must be reviewed to ensure that it is within normal limits before randomizing a participant into the study.\n16. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG and vital signs, or physical findings at Screening. In case of uncertain or questionable results, tests performed during Screening may be repeated once to confirm eligibility or judged to be clinically irrelevant.\n17. Other eligibility considerations (i.e., participant personal circumstances, behavior, and/or any current problem that might interfere with participation or that is incompatible with establishment of rapport or safe exposure to psilocin), as judged by the Investigator.\n18. History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion (ADME) of the study drug.\n19. Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study.\n20. Participant is not fluent in English. Participants must be fluent in English because the consent form as well as all assessments are written and will be administered/communicated in English.\n21. Aspartate aminotransferase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT) or total bilirubin levels ≥1.5 x the upper limit of normal (ULN) at Screening. These laboratory evaluations may be repeated once at the discretion of the Investigator. If the repeat test is within the reference range, the participant may be included if the Investigator considers that the previous finding will not introduce additional risk factors.\n22. Positive urine test for drugs of abuse or alcohol breath test at Screening or Day 1. A positive test for cannabinoids (e.g., marijuana) at Screening may not exclude a participant if after discussion with and evaluation by the Investigator, the participant agrees not to use any marijuana or other cannabinoid products during the study, and if allowed to participate, the participant must test negative for cannabinoids on Day 1.\n23. Participant who consumes excessive amounts of caffeine (e.g., coffee, tea, caffeinated sodas) or (methyl) xanthines (e.g., chocolate) based on the Investigator's determination and discretion.\n24. The participant has participated in a clinical study and has received a medication or a new chemical entity within 3 months prior to dosing of current study medication.\n25. Known sensitivity to psilocybin, psilocin and/or any excipients present in the formulation.\n26. Participant is taking or has taken any drugs known to inhibit monoamine oxidase within 28 days prior to study drug administration.\n27. Participant is taking or has taken OTC doses of 5-hydroxytryptophan or St John's Wort within 28 days prior to study drug administration.\n28. Strenuous exercise within 48 hours prior to each visit, and while at the study site.\n29. Participants capable of producing sperm who will not abstain from sperm donation between first dosing and 3 months after final dosing.\n30. Participants of childbearing potential who are pregnant, breastfeeding or planning to conceive. This is an FDA requirement.","locations":[{"facility":"The Ohio State University Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anthony King, PhD","phone":"614 688-9537","email":"anthony.king@osumc.edu"},{"name":"Wenfei Yu, BS","phone":"614 688-9537","email":"wenfei.yu@osumc.edu"}],"primaryOutcomes":["Changes in parameter estimate of regional brain activity measured by fMRI after one dose of psilocybin in participants with PTSD","Changes in region-to-region connectivity measured by fMRI after PAT with one dose of psilocybin in patients with PTSD","Changes in event related potentials (ERP) after PAT with one dose of psilocybin in participants with PTSD","Changes in acoustic startle electromyographic (EMG) response after PAT with one dose of psilocybin in patients with PTSD"],"hasResults":false,"conditionSlugs":["depression","ptsd"],"drugSlugs":["psilocybin"],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Phase 2: Psilocybin + MBCT therapy for Post Traumatic Stress Disorder","inPlainEnglish":"The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD). This is an assessor-blinded, randomly assigned, controlled study in participants with PTSD.","whoItsFor":["Ages 21 Years to 65 Years","Participants meeting the following criteria will be included in the study:","Participant is assigned female or male at birth","Participant is aged between 21 to 65 years, inclusive, at Screening. This is to reduce variability in brain function and connectivity in this small pilot study that may be related to age / developmental factors in persons under 21 and over 65","Participant has a body-mass index (BMI) of 18 to 30 kg/m2, inclusive, at Screening","PTSD severity moderate to severe based on CAPS-5 score ≥25, and with moderate depression MADRS ≥20"],"whoShouldSkip":["Participants with the following will be excluded from study participation:","Cardiovascular disease, including coronary artery disease (CAD) and congestive heart failure (CHF). This is an FDA requirement","Currently receiving a monoamine oxidase inhibitor, tricyclic antidepressant, other non-SSRI or non-SNRI antidepressants (e.g. bupropion, mirtazapine, etc), an antipsychotic or a mood stabilizer","Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD or peyote more than 10 times in the last 10 years, or any psychedelic use within 6 months prior to Screening","Family history of schizophrenia or schizoaffective disorder (first degree relatives), or bipolar disorder type 1 (first degree relatives)","Diagnosis of hypertension or arrhythmia","Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgement"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin + MBCT therapy, or Active Comparator: Psilocybin with Support Only. The registry lists allocation as randomized. The goal of this study is to learn how psilocybin delivered with mindfulness-based therapy may help symptoms of posttraumatic stress disorder (PTSD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Columbus. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.416Z"},{"nctId":"NCT07105436","title":"Thopaz for PALs Evaluation","officialTitle":"Utility of the Thopaz+ System in Evaluating Persistent Air Leaks","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Kai Swenson","sponsorClass":"OTHER","summary":"Persistent air leaks (PALs) are a common postoperative complication resulting from tears in the visceral pleura or peripheral lung resections. Although highly prevalent with significant consequences, traditional assessment methods lack the capability to objectively quantify air leaks, which further complicates management, results in inconsistent decision making, and prolongs hospital stays. By incorporating the Thopaz+ system, the investigators can introduce a reliable approach to objectively quantify air leaks, potentially improving clinical outcomes.\n\nThe purpose of this protocol is to perform a pilot prospective controlled clinical trial to evaluate the utility of incorporating the Thopaz+ system and its volume quantification ability in evaluating patients with persistent air leaks (PALs) to guide treatment decisions, specifically endobronchial valves (EBVs).\n\nIn the targeted cohort, the Thopaz+ will be connected to the chest tube and the data collected will be combined with that of serial balloon occlusion testing with a Fogarty balloon to accurately localize the air leak source, and subsequently consider the correct placement of EBVs. The investigators will thereby determine whether this experimental strategy will yield a more accurate and objective assessment of air leaks, facilitating timely interventions and improved patient outcomes.","conditions":["Persistent Air Leaks"],"keywords":["Persistent Air Leaks","Chest Tube","Waterseal","Thopaz+"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Persistent air leak quantification"}],"enrollment":20,"startDate":"2026-01-01","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospitalized with a persistent air leak (PAL) lasting ≥5 days despite continuous chest tube drainage.\n* Undergoing bronchoscopy as part of clinical care for PAL management.\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Contraindications to bronchoscopy or EBV placement.\n* Pregnancy.\n* Inability to tolerate general anesthesia.","locations":[{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kai Swenson, MD","phone":"617-632-8386","email":"BIDMC-IPResearchTeam@bidmc.harvard.edu"}],"primaryOutcomes":["Number of Participants with Successful Intraoperative Quantification of Air Leak Volume Using Thopaz+ Digital Drainage System"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Persistent air leak quantification for Persistent Air Leaks","inPlainEnglish":"Persistent air leaks (PALs) are a common postoperative complication resulting from tears in the visceral pleura or peripheral lung resections. Although highly prevalent with significant consequences, traditional assessment methods lack the capability to objectively quantify air leaks, which further complicates management, results in inconsistent decision making, and prolongs hospital stays.","whoItsFor":["Ages 18 Years to any","Hospitalized with a persistent air leak (PAL) lasting ≥5 days despite continuous chest tube drainage","Undergoing bronchoscopy as part of clinical care for PAL management"],"whoShouldSkip":["Contraindications to bronchoscopy or EBV placement","Inability to tolerate general anesthesia"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.440Z"},{"nctId":"NCT07105670","title":"Effects of Replacing High Protein Foods in People With Chronic Kidney Disease","officialTitle":"The Effects of Replacing Red Meat With Alternative Protein Sources on Gut-Derived Metabolites in People With Chronic Kidney Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Indiana University","sponsorClass":"OTHER","summary":"The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.","conditions":["Chronic Kidney Disease Stage 3"],"keywords":[],"interventions":[{"type":"OTHER","name":"Controlled dietary intervention"}],"enrollment":15,"startDate":"2027-02-01","completionDate":"2028-06-30","sex":"ALL","minAge":"40 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 40-70 years\n* Male or postmenopausal female\n* Stage 3 CKD (eGFR between 30-59ml/min/1.73m\\^2 by the CKD-EPI equation (without race correction)).\n* If eGFR is greater than or equal to 45ml/min/1.73m\\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine.\n* Willing to consume controlled diet for duration of the study\n* Willing to collect fecal samples at home\n\nExclusion Criteria:\n\n* Hemoglobin A1c greater than 7% within previous six months\n* Treatment with metformin or insulin within previous three months\n* Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)\n* Change in cardiovascular and/or hypertension medication in the last 30 days\n* History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)\n* Known HIV disease\n* Hospitalization in the last two months\n* Significant recent unintentional weight loss (5% of weight over past three months)\n* Cancer or received cancer treatment in the last year (except basal cell carcinoma)\n* Prior bariatric surgery (i.e. gastric bypass, sleeve gastrectomy) or restrictive bariatric surgery (i.e. adjustable gastric band)\n* Treatment with immunosuppressive medications in the past six months or more than one week of treatment with prednisone greater than 10mg per day in the past three months (or equivalent steroid dose of non-prednisone steroids)\n* Recent antibiotic use defined as a single course of antibiotics within the past three months or two or more courses within the past six months\n* Known food allergy that would influence the ability to consume the study diets\n* History of hyperkalemia defined as greater than 5.5mmol/L on at least two occasions\n* Other medical conditions or concerns at the discretion of the investigators","locations":[{"facility":"Purdue University","city":"West Lafayette","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brandon Kistler","phone":"765-494-5406","email":"bmkistle@purdue.edu"}],"primaryOutcomes":["Serum trimethylamine N-oxide"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["west-lafayette-indiana"],"enrichment":{"headline":"Not a traditional drug phase: Controlled dietary intervention for Chronic Kidney Disease Stage 3","inPlainEnglish":"The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.","whoItsFor":["Ages 40 Years to 70 Years","Male or postmenopausal female","Stage 3 CKD (eGFR between 30-59ml/min/1.73m\\^2 by the CKD-EPI equation (without race correction))","If eGFR is greater than or equal to 45ml/min/1.73m\\^2 then albuminuria must be greater than 300mg/g creatinine by spot urine","Willing to consume controlled diet for duration of the study","Willing to collect fecal samples at home"],"whoShouldSkip":["Hemoglobin A1c greater than 7% within previous six months","Treatment with metformin or insulin within previous three months","Blood pressure greater than 150/100 mmHg from chart of home on at least two occasions in prior month (can be inclusive of screening visit)","Change in cardiovascular and/or hypertension medication in the last 30 days","History of major gastrointestinal disease (e.g. inflammatory bowel disease, uncontrolled irritable bowel syndrome, C. difficile chronic infection, celiac disease, diverticulitis, stomach or duodenal ulcers)","Hospitalization in the last two months","Significant recent unintentional weight loss (5% of weight over past three months)"],"whatHappens":"If you join, the listed intervention(s) are Controlled dietary intervention. The registry lists allocation as randomized. The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 15 people at West Lafayette. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.488Z"},{"nctId":"NCT07107334","title":"A Study to Estimate Early Clinical Efficacy Signals of GLP-1 Agonist Administration in Conjunction With Levonorgestrel Intrauterine Device in Obese Patients With Endometrioid Intraepithelial Neoplasia","officialTitle":"A Pilot Study to Estimate Early Clinical Efficacy Signals of a Glucagon-like Peptide 1 Receptor Agonist (GLP-1RA) Administration in Conjunction With Levonorgestrel Intrauterine Device (LNG-IUD) in Obese Patients With Endometrioid Intraepithelial Neoplasia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Florida","sponsorClass":"OTHER","summary":"This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1. These medications trigger the pancreas to release insulin which can help lower blood sugar levels and delay gastric emptying. The recent FDA approval of GLP-1RAs has changed the landscape for pharmacotherapy for weight loss. These hormone-based obesity medications are novel and revolutionary in obesity medicine. Liraglutine, semaglutide, and tirzepatide have become exceedingly popular for their effects on weight loss and obesity-related comorbidities. More recently, GLP-1RAs have exhibited risk reduction of various obesity associated cancers, including endometrial cancer but their exact role in prevention and treatment has yet to be measured.","conditions":["Endometrioid Endometrial Adenocarcinoma"],"keywords":["Endometrial cancer","endometrial intraepithelial neoplasia","endometrial adenocarcinoma","Levonorgestrel IUD"],"interventions":[{"type":"DRUG","name":"Glucagon-like peptide 1 receptor agonist"}],"enrollment":20,"startDate":"2026-04-07","completionDate":"2028-11","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥ 18 years old\n* A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN\n* For subjects with a diagnosis of endometrial intraepithelial neoplasia/grade 1 endometrioid endometrial adenocarcinoma prior to enrollment in the study, and with a diagnosis made outside this institution, the diagnostic material originating from outside the study site will undergo in-house pathology review before enrollment acceptance.\n* ECOG Performance Status of 0 to 3\n* For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound\n* BMI ≥ 30 kg/m2 and one of the following (per medical record or self-report):\n\n  1. Multiple medical co-morbidities (defined as American Society of Anesthesiologists \\[ASA\\] score ≥ 3) at physician discretion\n  2. Fertility desire\n* Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation.\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n\nExclusion Criteria:\n\n* Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)\n* Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging\n* Subjects with abnormal cervical cytology\n* Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2\n* Subjects who are confirmed to be pregnant or breastfeeding\n* History of medullary thyroid cancer\n* Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)\n* Subjects actively taking GLP-1RA for more than 14 days at time of consent.\n* Subjects with levonorgestrel-releasing intrauterine system placed \\>45 days prior to study enrollment.\n* Subjects must not have more than one active malignancy at the time of enrollment (Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety or efficacy assessment of the study \\[as determined by the treating physician or approved by the PI\\] may be included).\n* History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician. This includes, but is not limited to, conditions such as New York Heart Association (NYHA) Class IV heart failure.\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","locations":[{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amber N Batie","phone":"(352) 273-8457","email":"amberbatie@ufl.edu"},{"name":"Laura J Mallinson","phone":"(352) 265-5125","email":"coppola@ufl.edu"}],"primaryOutcomes":["Time from start of GLP-1RA to clearance of staging hysterectomy","Time from start of GLP-1RA to clearance for pregnancy pursuit","Endometrial pathologic response","Endometrial pathologic response"],"hasResults":false,"conditionSlugs":["endometrial-cancer","als","obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["gainesville-florida"],"enrichment":{"headline":"Phase 2: testing Glucagon-like peptide 1 receptor agonist for Endometrioid Endometrial Adenocarcinoma","inPlainEnglish":"This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing. GLP-1RA are a class of medications that mimic the natural hormone glucagon-like peptide-1.","whoItsFor":["Ages 18 Years to any","Women only","Adults ≥ 18 years old","A pathological diagnosis with in the past 4 months consistent with grade 1 endometrioid endometrial adenocarcinoma or EIN","how well you can do daily activities (ECOG score) of 0 to 3","For those with endometrial cancer, no extrauterine involvement or myometrial invasion by MRI (preferred) or transvaginal ultrasound","body-mass index (BMI) ≥ 30 kg/m2 and one of the following (per medical record or self-report):","Multiple medical co-morbidities (defined as American Society of Anesthesiologists \\[ASA\\] score ≥ 3) at physician discretion","Subject has had appropriate age-related breast examinations and imagining prior to study enrollment, as documented in the medical record or via investigator confirmation"],"whoShouldSkip":["Subjects with grade 2 or 3 endometroid or any non-endometrioid histology (i.e., clear cell, carcinoma, serous)","Clinical suspicion of metastatic disease as assessed by the treating physician or confirmed metastatic disease based on imaging","Subjects with abnormal cervical cytology","Subjects who are diagnosed with thyroid cancer, pancreatitis, or multiple endocrine neoplasia syndrome type 2","Subjects who are confirmed to be pregnant or breastfeeding","History of medullary thyroid cancer","Subjects with known current or history of hormonally- sensitive carcinoma (e.g., breast, melanoma)"],"whatHappens":"If you join, the listed intervention(s) are Glucagon-like peptide 1 receptor agonist. The registry lists allocation as na. This study will explore the use of glucagon-like peptide 1 receptor agonist (GLP-1RA) used concurrently with levonorgestrel intrauterine device in patients with poor surgical candidacy for a hysterectomy or patients who are pursuing fertility sparing.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Gainesville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.731Z"},{"nctId":"NCT07108868","title":"A Phase I Dose Finding Study of MB-CART2219.1","officialTitle":"A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital Tuebingen","sponsorClass":"OTHER","summary":"A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies","conditions":["Lymphoma","CLL","Acute Lymphoblastic Leukemia, Pediatric"],"keywords":["MB-CART2219.1 targeting CD19/CD22","CD19/CD22","CAR-T cells"],"interventions":[{"type":"BIOLOGICAL","name":"CAR-T cells targeting CD19 and CD22"}],"enrollment":36,"startDate":"2025-06-23","completionDate":"2027-03","sex":"ALL","minAge":"12 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. For Cohort I Lymphoma, adults: Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. For Cohort II ALL, pediatric patients: Subject is ≥ 12-17 years of age at the time of signing ICF.\n3. Patient or legal guardian understand and voluntarily sign an informed consent document prior to any study related assessments/procedures.\n4. Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials.\n5. CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available.\n6. Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure.\n7. All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment.\n8. Male or female patients must have relapsed refractory (r/r) CD19 or CD22 -expressing ALL or Lymphoma/CLL and meet the following disease-specific criteria.\n\nCohort I: Lymphoma (Richter's Transformation /Burkitt lymphoma/NHL/CLL), Adults ≥18 years of age:\n\n* Disease entities: Patients with relapsed or refractory (r/r) B-cell lymphoid malignancies according to the WHO Classification of Haematolymphoid Tumours (5th edition), including:\n\n  * B-lymphoblastic lymphoma\n  * Chronic lymphocytic leukemia (CLL)\n  * Splenic B-cell lymphoma\n  * Marginal zone lymphoma\n  * Follicular lymphoma\n  * Mantle cell lymphoma\n  * Diffuse large B-cell lymphoma (DLBCL) / Large B-cell lymphoma\n  * Burkitt lymphoma\n  * Transformed indolent B-cell lymphoma (including Richter's transformation)\n* Prior treatment and disease status: Patients must meet one of the following criteria:\n\n  1. Relapsed or refractory disease after ≥2 prior systemic therapies, including at least one of the following (if clinically indicated and available):\n\n     * Approved CAR-T cell therapy, or\n     * Bispecific antibody therapy OR\n  2. Contraindication to CAR-T cell therapy and/or bispecific antibody therapy\n* CLL-specific: Patients with relapsed or refractory CLL:\n\n  * After failure of established and approved treatment options\n  * Including prior exposure to BTK inhibitor-based therapy\n* Transplant-related eligibility: Patients fulfilling at least one of the following:\n\n  1. Indication for autologous or allogeneic stem cell transplantation (SCT) as determined by a multidisciplinary board, but ineligible for SCT, or declining SCT after informed consent discussion\n  2. Patients with refractory disease currently precluding alloSCT, including those considered for bridging to allogeneic SCT within the study framework\n* Post-transplant or post-targeted therapy relapse: Patients meeting at least one of the following:\n\n  1. Relapse following autologous or allogeneic SCT\n  2. Relapse following CD19- or CD22-directed therapy\n  3. Confirmed expression of CD19 or CD22 at relapse\n* Central nervous system (CNS) involvement\n\n  1. Patients with CNS involvement by lymphoma are eligible\n  2. Provided that CNS disease is adequately controlled at the time of study inclusion Or\n\nCohort II: Acute B-lymphoplastic Leukemia (B-ALL), pediatric patients aged ≥ 12 - 17 years:\n\n* Patients with second or later relapse of ALL with \\>5% blasts in BM or rising molecular failure on two separate measurements and without an approved option for in label CAR-T cells or bispecific or cytotoxic antibody treatment.\n* Patients with relapse after SCT or other CD19 or CD22 targeted treatment with confirmed either CD19 or CD22 expression after relapse.\n* Patients not consenting or ineligible for allogeneic SCT or have refractory disease activity precluding allogemeoc SCT at this time, or\n* Patients with Ph+ ALL if they are intolerant to tyrosine kinase inhibitor (TKI) therapy, or if they have r/r disease after treatment with at least 2 different TKIs.\n* ALL patients with combined bone marrow and CNS and/or testicular relapse are eligible only if the extramedullary disease has been successfully controlled by conventional therapy at the time of inclusion (e.g. intrathecal chemotherapy, orchiectomy).\n* Patients with ALL in hematologic remission after induction treatment, but ineligible for full execution of further standardly recommended treatments because of medical or other reasons.\n\nExclusion Criteria:\n\n1. Subject received any of the following within the last 7 days of leukapheresis:\n\n   * Any investigational agent\n   * Immunsupressive medication\n   * Plasmapheresis\n   * Major surgery (as defined by the investigator)\n   * Radiation therapy other than local therapy for underlying malignancy\n   * Use of any systemic anti-neoplastic drug therapy or immune suppressive medication applied for graft versus-host-disease or other, including the use of high dose steroids e.g. \\>0,5 mg/kg BW methylprednisolone other than hydrocortisone replacement and other than intermittent topical, inhaled or intranasal corticosteroids which are allowed\n2. Subject has ECOG ≥ 3 at screening for inclusion in the trial\n3. Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease\n4. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or other CNS bleed, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis\n5. Subject has any of the following laboratory abnormalities:\n\n   * Absolute neutrophil count (ANC) \\< 500/μL\n   * Platelet count \\< 50,000 mm3 (platelet transfusion allowed)\n   * Serum Creatinine Clearance (CrCl) \\< 30 mL/min\n   * Corrected serum calcium \\> 13.5 mg/dL (\\> 3.4 mmol/L)\n   * Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × upper limit of normal (ULN)\n   * Serum total bilirubin \\> 1.5 × ULN or \\> 3.0 mg/dL for subjects with documented Gilbert's syndrome or if part of disease involvement\n   * International ratio (INR) or partial thromboplastin time (PTT) \\> 1.5 × ULN, or history of Grade ≥ 2 hemorrhage within 30 days, or subject requires ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors)\n6. Patient has no adequate vascular access for leukapheresis\n7. Echocardiogram (ECHO) or multi-gated acquisition (MUGA) with left ventricular ejection fraction \\< 40%\n8. Patient with a history of Class III or IV congestive heart failure (CHF) or severe nonischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 3 months prior to starting study treatment\n9. Inadequate pulmonary function defined as oxygen saturation (Sa02) \\< 90 % on room air\n10. Subject has history of primary immunodeficiency\n11. Subject is positive for human immunodeficiency virus (HIV-1), uncontrolled hepatitis B or C or active hepatitis A\n12. Subject with ongoing (incl. controlled) infections or infestations where inclusion of the patient into the clinical trials may significantly jeopardize the health and wellbeing of the patient, as determined by the investigator.\n13. Subject with malignancy other than the underlying malignancy in this protocol, unless this disease has been controlled for ≥ 1 year and the exception of the following noninvasive malignancies:\n\n    * Basal cell carcinoma of the skin\n    * Squamous cell carcinoma of the skin\n    * Carcinoma in situ of the cervix\n    * Carcinoma in situ of the breast\n    * Incidental histologic finding of prostate cancer (T1a or T1b using the TNM \\[tumor, nodes, metastasis\\] clinical staging system) or prostate cancer that is curative\n14. Patient is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during participation in the study\n15. Patient with known hypersensitivity to any component of MB-CART2219.1 product, cyclophosphamide, fludarabine, and/or tocilizumab\n16. Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study\n17. Patient has any further condition including the presence of further laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study","locations":[{"facility":"University Hospital , Department of Internal Medicine II","city":"Tübingen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital, Clinic for Pediatric Medicine","city":"Tübingen","state":"Baden-Wurttemberg","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wolfgang Bethge, Prof. Dr.","phone":"+49 7071 29-83176","email":"Wolfgang.Bethge@med.uni-tuebingen.de"},{"name":"Tim Flaadt, Dr.","phone":"+49 7071 29-80894","email":"Tim.Flaadt@med.uni-tuebingen.de"}],"primaryOutcomes":["Safety and feasibility Phase I (CTCAE)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":["car-t"],"locationSlugs":["t-bingen-germany"],"enrichment":{"headline":"Phase 1: testing CAR-T cells targeting CD19 and CD22 for Lymphoma","inPlainEnglish":"A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies","whoItsFor":["Ages 12 Years to 75 Years","For Cohort II ALL, pediatric patients: Subject is ≥ 12-17 years of age at the time of signing ICF","Able to adhere to the study visit schedule and other protocol requirements as well as agrees to continued follow up for up to 15 years as mandated by the regulatory guidelines for gene therapy trials","CD19 or CD22 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry. Results of previous assessments after the last treatment with CD19 targeted therapies but preceding inclusion of the patient in this trial are acceptable, if available","Female Subject of childbearing potential and male subjects with female partner of childbearing potential is willing to use highly effective contraceptive methods during treatment until 12 months after IMP exposure","All subjects must agree to refrain from donating blood while on study drug and for 1 year after discontinuation from this study treatment","Male or female patients must have relapsed refractory (r/r) CD19 or CD22 -expressing ALL or Lymphoma/CLL and meet the following disease-specific criteria","Cohort I: Lymphoma (Richter's Transformation /Burkitt lymphoma/NHL/CLL), Adults ≥18 years of age:"],"whoShouldSkip":["Subject received any of the following within the last 7 days of leukapheresis:","Any investigational agent","Immunsupressive medication","Major surgery (as defined by the investigator)","Radiation therapy other than local therapy for underlying malignancy","Subject has ECOG ≥ 3 at screening for inclusion in the trial","Subject has clinical evidence of pulmonary leukostasis, disseminated intravascular coagulation or active graft versus-host-disease"],"whatHappens":"If you join, the listed intervention(s) are CAR-T cells targeting CD19 and CD22. The registry lists allocation as na. A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.402Z"},{"nctId":"NCT07109739","title":"Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function","officialTitle":"Dose-Response Effects of Inspiratory Muscle Strength Training on Blood Pressure and Vascular Function","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Minnesota","sponsorClass":"OTHER","summary":"This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.","conditions":["Systolic Hypertension","Brachial Artery Flow-mediated Dilation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"POWERbreathe K5"}],"enrollment":144,"startDate":"2025-10-24","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Resting SBP ≥120 mmHg as measured during screening 1 \\& 2\n* Free from serious CV or metabolic diseases as identified by self-report and blood chemistry analysis.\n* No contraindications to IMST (recent abdominal surgery, ruptured eardrum, asthma with very low symptom perception, fractured ribs, or pneumothorax)\n* Language: English-speaking, with ability to comprehend study materials and instructions.\n* Pre-visit Compliance: Willing to comply with pre-visit instructions (avoiding food and caffeine ≥ 3 hours, vigorous exercise, alcohol, and non-prescribed medications ≥ 24 hours) prior to each measurement visit.\n* Lifestyle: Non-smokers (defined as self-report of not smoking cigarettes or vaping over the past year).\n\nExclusion Criteria:\n\n* Self-report of history of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum).\n* Recent abdominal surgery or presence of an abdominal hernia.\n* Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea.\n* Ruptured eardrum or any other condition of the ear.\n* Markedly elevated left ventricular end-diastolic volume and pressure.\n* Current respiratory conditions such as a cold, sinusitis, or respiratory tract infection (participants may be included once they recover from the respiratory condition).\n* Female-Specific: Pregnant or planning to become pregnant during the study period.\n* Compliance: Unable or unwilling to comply with pre-visit restrictions (e.g., avoiding caffeine, alcohol, and exercise within specified hours before visits).","locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Olivia Ruhland","phone":"612-624-1588","email":"ruhla064@umn.edu"}],"primaryOutcomes":["Systolic Blood Pressure at 6 Weeks"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["minneapolis-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: POWERbreathe K5 for Systolic Hypertension","inPlainEnglish":"This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.","whoItsFor":["Ages 18 Years to any","Resting SBP ≥120 mmHg as measured during screening 1 \\& 2","Free from serious CV or metabolic diseases as identified by self-report and blood chemistry analysis","No contraindications to IMST (recent abdominal surgery, ruptured eardrum, asthma with very low symptom perception, fractured ribs, or pneumothorax)","Language: English-speaking, with ability to comprehend study materials and instructions","Lifestyle: Non-smokers (defined as self-report of not smoking cigarettes or vaping over the past year)"],"whoShouldSkip":["Self-report of history of cardiovascular disease, or conditions affecting the ear (e.g., ruptured eardrum)","Recent abdominal surgery or presence of an abdominal hernia","Asthma with very low symptom perception, frequent severe exacerbations, or abnormally low perception of dyspnea","Ruptured eardrum or any other condition of the ear","Markedly elevated left ventricular end-diastolic volume and pressure","Current respiratory conditions such as a cold, sinusitis, or respiratory tract infection (participants may be included once they recover from the respiratory condition)","Female-Specific: Pregnant or planning to become pregnant during the study period"],"whatHappens":"If you join, the listed intervention(s) are POWERbreathe K5. The registry lists allocation as randomized. This study will assess the dose-response effects of Inspiratory Muscle Strength Training (IMST) in adults with above-normal systolic blood pressure over a 6-week period.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 144 people at Minneapolis. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.036Z"},{"nctId":"NCT07110337","title":"Diagnosing Epilepsy To EffeCT Change","officialTitle":"A Prospective Study to Evaluate the Use of the Minder Device to Aid in Developing a Treatment Plan After Inconclusive Prolonged EEG in Patients With Epilepsy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"DOUBLE","sponsor":"Epiminder America, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.\n\nParticipants will consent to join the study and be implanted with the Minder device; or consent to join the study and continue with their Standard of Care (SOC) as a control group. Participants chose to be implanted with the Minder device will have the device implanted under their scalp. After implantation, participants will be randomly assigned to a group where their treating physician will have access to the EEG data collected by the Minder System or a group where their treating physician does not have access to the EEG data collected by the Minder System. Participants receiving the Minder System will not know which group they are in (blinded) until the study ends.\n\nAll participants will continue to be followed by their treating physician and undergo assessments and visits until enough information is available to determine a treatment plan or the 6-month follow-up visit.","conditions":["Epilepsy","Epilepsy (Treatment Refractory)"],"keywords":["Minder System","Sub-scalp EEG monitoring device"],"interventions":[{"type":"DEVICE","name":"Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system)"}],"enrollment":210,"startDate":"2025-12-23","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of focal and/or generalized epilepsy.\n* Drug-resistant\n* At least an average of 1 seizure within the past 3 months\n* Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring.\n\nExclusion Criteria:\n\n* Epilepsy surgery within the past 6 months\n* Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)\n* Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy\n* Participant cannot have surgery to have the device implanted","locations":[{"facility":"UAB Epilepsy Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine Medical Center","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nicklaus Children's Hospital","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USF Health","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IU Health Neuroscience Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Medicine","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Neurosciences Institute - Charlotte","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Clevland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Epiminder, Director of Clinical Trials","phone":"800-717-3185","email":"clinical@epiminder.com"}],"primaryOutcomes":["Compare the proportion of participants receiving the Minder System with those receiving Standard of Care (SOC) as a means of obtaining an actionable event based on clinical data (i.e. Minder EEG data, non-Minder EEG data, SOC assessments, etc.)."],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","irvine-california","palo-alto-california","san-diego-california","new-haven-connecticut","jacksonville-florida","miami-florida","tampa-florida","indianapolis-indiana","boston-massachusetts","ann-arbor-michigan","minneapolis-minnesota","rochester-minnesota","st-louis-missouri","billings-montana","charlotte-north-carolina","durham-north-carolina","clevland-ohio","philadelphia-pennsylvania","dallas-texas","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system) for Epilepsy","inPlainEnglish":"The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research will compare the Minder System to standard of care in providing reliable seizure data.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of focal and/or generalized epilepsy","At least an average of 1 seizure within the past 3 months","Participant completed a multi-day EEG assessment that was inconclusive, and is unchanged since the last EEG monitoring"],"whoShouldSkip":["Epilepsy surgery within the past 6 months","Active Deep Brain Stimulation (DBS) or Responsive Neurostimulator System (RNS)","Participant needs treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI), Electro-Convulsive Therapy (ECT), lithrotripsy, and diathermy","Participant cannot have surgery to have the device implanted"],"whatHappens":"If you join, the listed intervention(s) are Receipt of the Minder System (implantable sub-scalp continuous electroencephalographic (EEG) monitoring (iCEM) system). The registry lists allocation as randomized. The purpose of this research is to address the challenges of diagnosing and long-term management of epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 210 people at 23 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.917Z"},{"nctId":"NCT07111494","title":"Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial","officialTitle":"Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Medical College of Wisconsin","sponsorClass":"OTHER","summary":"Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.\n\nThe main objectives it aims to answer are:\n\nTo assess disease outcomes of PsA patients undergoing treatment for concomitant obesity and type 2 diabetes with GLP-1 analogs vs nutrition counseling.\n\nTo assess effectiveness as measured by clinical and patient reported outcome measures in patients treated with GLP-1 and nutrition counseling.\n\nParticipants will be randomized to receive a GLP-1 or nutrition counseling. Participants will be asked to come to the study center at most four times during a 24-week period. During this time participants will be asked to fill out questionnaires, receive a physical exam, and have their blood drawn.","conditions":["Psoriatic Arthritis (PsA)"],"keywords":["Psoriatic Arthritis","GLP-1","Minimal Disease Activity","Nutrition Counseling"],"interventions":[{"type":"DRUG","name":"GLP-1 agonists"},{"type":"OTHER","name":"Nutrition Counseling"}],"enrollment":22,"startDate":"2026-05-01","completionDate":"2027-10-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients (age 18 and older) who present to rheumatology clinic\n* Participants must be able to read, understand, and provide documented informed consent as approved by the Institutional Review Board (IRB).\n* Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA\n* Participants must have a Body Mass Index (BMI) of 30kg/m\\^2\n* Participants must be treated for PsA in accordance with guidelines\n* Have not achieved MDA in PsA patients\n* Have a minimum TJC \\> 1 and SJC \\> at baseline\n* Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator.\n\nExclusion Criteria:\n\n* Any prior use of GLP-1 agonists\n* Inability to provide informed consent\n* Current participation in another PsA study\n* Treatment initiation by GLP-1 agonists contraindicated by FDA\n* Patients with hemoglobin A1c (HbA1c) \\> 10 at baseline","locations":[{"facility":"Medical College of Wisconsin/Froedtert Hosptial","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change from the baseline Minimal Disease Activity (MDA) Scores at Week 12 and 24 with GLP-1 Agonists vs Nutrition Counseling","Proportion of Patients who Achieve Disease Activity in Psoriatic Arthritis (DAPSA) Remission with GLP-1 Agonists Vs. Nutrition Counseling at Week 12 and 24"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["milwaukee-wisconsin"],"enrichment":{"headline":"Phase 4: testing GLP-1 agonists for Psoriatic Arthritis (PsA)","inPlainEnglish":"Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body. This study will assess if the effectiveness of Glucagon-like peptide-1 (GLP-1) medications used to treat type 2-diabetes and weight management, or nutrition counseling can better treat individuals with Psoriatic Arthritis who are also needing treatment for obesity and type 2 diabetes.","whoItsFor":["Ages 18 Years to any","Adult patients (age 18 and older) who present to rheumatology clinic","Meet the Classification of Psoriatic Arthritis (CASPAR) criteria for PsA","Participants must have a Body Mass Index (body-mass index (BMI)) of 30kg/m\\^2","Participants must be treated for PsA in accordance with guidelines","Have not achieved MDA in PsA patients","Have a minimum TJC \\> 1 and SJC \\> at baseline","Eligible for GLP-1 agonist treatment in accordance with Food Drug Administration (FDA) labeling as determined by the investigator"],"whoShouldSkip":["Any prior use of GLP-1 agonists","Current participation in another PsA study","Treatment initiation by GLP-1 agonists contraindicated by FDA","Patients with hemoglobin A1c (HbA1c) \\> 10 at baseline"],"whatHappens":"If you join, the listed intervention(s) are GLP-1 agonists, or Nutrition Counseling. The registry lists allocation as randomized. Psoriatic arthritis (PsA) is a chronic inflammatory condition that affects the joints but can also have an effect on multiple parts of the body.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 22 people at Milwaukee. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.575Z"},{"nctId":"NCT07112378","title":"A Study of Dupilumab in Small Children With an Allergic Condition of the Esophagus (Food Pipe): Eosinophilic Esophagitis","officialTitle":"A Randomized Study Evaluating 2 Dose Regimens of Dupilumab in Children ≥6 Months of Age Weighing ≥5 to <15 kg With Active Eosinophilic Esophagitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called dupilumab (called \"study drug\"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is when given for 24 weeks to children with active EoE.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)","conditions":["Eosinophilic Esophagitis (EoE)"],"keywords":["Type 2 Inflammatory","Allergic/immune-mediated","Esophageal dysfunction"],"interventions":[{"type":"DRUG","name":"dupilumab"}],"enrollment":20,"startDate":"2025-11-10","completionDate":"2028-06-19","sex":"ALL","minAge":"6 Months","maxAge":"6 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Pediatric patients aged ≥6 months and weighing ≥5 kg and \\<15 kg at screening with active EoE\n2. History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol\n3. Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab\n2. Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study\n3. Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)\n4. Active Helicobacter pylori infection\n5. History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery\n6. Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening\n7. History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure\n8. Treatment with swallowed topical corticosteroids within 8 weeks prior to baseline standard of care endoscopy\n\nNOTE: Other Protocol-Defined Inclusion/Exclusion Criteria Apply","locations":[{"facility":"Phoenix Childrens Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco (UCSF)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Care for Kids LLC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina, Bioinformatics Building","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cook Children's Medical Center","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin, Children's Hospital of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Incidence of treatment-emergent Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dupilumab"],"locationSlugs":["phoenix-arizona","san-francisco-california","aurora-colorado","atlanta-georgia","boston-massachusetts","new-york-new-york","chapel-hill-north-carolina","philadelphia-pennsylvania","charleston-south-carolina","fort-worth-texas","charlottesville-virginia","seattle-washington","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 3: testing dupilumab for Eosinophilic Esophagitis (EoE)","inPlainEnglish":"This study is researching an experimental drug called dupilumab (called \"study drug\"). The study is focused on children with active eosinophilic esophagitis (EoE; an inflammatory disease of the esophagus) which impacts feeding and nourishment.","whoItsFor":["Ages 6 Months to 6 Years","Pediatric patients aged ≥6 months and weighing ≥5 kg and \\<15 kg at screening with active EoE","History of symptom(s) determined by the investigator to be the result of EoE in the month prior to screening, as defined in the protocol","Baseline endoscopic biopsies, performed during the screening period, with a demonstration on central reading of intraepithelial eosinophilic infiltration in at least 2 of the 3 biopsied esophageal regions, as defined in the protocol"],"whoShouldSkip":["Prior participation in a dupilumab clinical trial or past or current treatment with dupilumab","Initiation or change of a food-elimination diet regimen or re-introduction of a previously eliminated food group in the 6 weeks prior to screening. Patients on a food-elimination diet must remain on the same diet throughout the study","Other causes of esophageal eosinophilia or the following conditions: eosinophilic gastroenteritis, hypereosinophilic syndrome, and eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome)","Active Helicobacter pylori infection","History of Crohn's disease, ulcerative colitis, celiac disease, or prior esophageal surgery","Any esophageal stricture unable to be passed with a standard, diagnostic, upper endoscope or any critical esophageal stricture that requires dilation at screening","History of bleeding disorders or esophageal varices that, in the opinion of the investigator, would put the patient at undue risk for significant complications from an endoscopic procedure"],"whatHappens":"If you join, the listed intervention(s) are dupilumab. The registry lists allocation as randomized. This study is researching an experimental drug called dupilumab (called \"study drug\").","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 20 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.708Z"},{"nctId":"NCT07112443","title":"A Study to Assess How Effective and Safe NVD003 is for Treating Patients With Congenital Pseudarthrosis of the Tibia.","officialTitle":"A Phase 3 Randomized, Controlled Study to Assess the Efficacy and Safety of NVD003 Compared With Iliac Crest Bone Graft in Pediatric Participants Treated Surgically for Congenital Pseudarthrosis of the Tibia","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Novadip Biosciences","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the efficacy and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.","conditions":["Congenital Pseudarthrosis of Tibia"],"keywords":["tissue engineered therapy","bone graft","autologous","pediatric","congenital","non-union","pseudarthrosis","cellular therapy"],"interventions":[{"type":"BIOLOGICAL","name":"NVD003"},{"type":"PROCEDURE","name":"Iliac Crest Bone Graft"}],"enrollment":12,"startDate":"2025-09-02","completionDate":"2032-06","sex":"ALL","minAge":null,"maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant's parent(s)/legal guardian(s) have provided written informed consent (and assent has been provided by the participant, depending on age) for the study.\n2. Participant is of any sex, ≤17 years of age.\n3. Participant has been diagnosed with CPT (with or without NF1).\n4. Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4\n5. Participant is a candidate for surgical treatment using an internal fixation approach (intramedullary rod) based on CPT fracture status and general health status.\n6. Participant has serology and molecular test results at Visits 1 and 2 excluding the presence of human T-cell lymphoma virus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and syphilis.\n7. Participant can provide an adequate ATC sample volume.\n8. Participant weighs ≥5 kg/11 lb at Screening and on Day 1.\n9. Participant is not pregnant or lactating.\n10. If participant is of childbearing potential, is practicing highly effective methods of birth control from Screening to the end of the study:\n\n    * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Intravaginal\n      * Transdermal\n    * Progestogen-only hormonal contraception associated with inhibition of ovulation:\n\n      * Oral\n      * Injectable\n      * Implantable\n    * Intrauterine device\n    * Intrauterine hormone-releasing system\n    * Bilateral tubal occlusion\n    * Vasectomized partner\n    * Sexual abstinence, defined as refraining from heterosexual intercourse during study participation, is acceptable if this is the participant's usual lifestyle; periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and the lactational amenorrhea method are not acceptable methods of contraception Note: A participant is considered to be of childbearing potential if they are postmenarchal and premenopausal, unless surgically sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy).\n\n    If participant is sexually active and has a partner who may become pregnant (i.e., neither surgically sterile nor postmenopausal), agrees to use highly effective contraception (e.g., sterilization, birth control pills, Depo Provera injections, or contraceptive implants) from Screening to the end of the study.\n\n    Participant agrees to refrain from donating sperm or eggs from Screening to the end of the study.\n11. Participant and parent(s)/legal guardian(s) are able to understand all study information provided and are willing to return to the study facility for all visits, including follow-up evaluations.\n\nExclusion Criteria:\n\n1. Participant has bilateral CPT.\n2. Participant has evidence of plexiform neurofibroma of any size or nodular fibroma ≥1.2 inches/3 cm on the ipsilateral leg.\n3. Participant has a clinically significant infection at the fracture site or systemic infection.\n4. Participant's CPT fracture involves the metaphysis (i.e., not limited to the diaphysis).\n5. Participant has a CPT fracture, for which the surgeon intends to use an external fixation system (e.g., Ilizarov, Taylor spatial frame, rail, etc.) instead of, or in addition to, internal fixation.\n6. Participant has an autoimmune disease, with the exception of well-controlled type 1 diabetes or autoimmune thyroid disorders.\n7. Participant has an active (malignant) tumor.\n8. Participant has documented metabolic bone disease or any disorder, such as, but not limited, to osteogenesis imperfecta and osteomalacia, that could interfere with bone healing and bone metabolism.\n9. Participant has any chronic, ongoing, or planned use of medications that might affect bone metabolism or bone quality such as bisphosphonates, steroids, methotrexate, vitamin K antagonists, immunosuppressant therapy, or immunotherapy during the study.\n\n   Note that perioperative treatment with a bisphosphonate is allowed in Cohort A participants randomized to ICBG if its use is deemed SOC by the treating surgeon.\n10. Participant has any history of allergic reaction or any anticipated hypersensitivity to any anesthetic agent or any potential hypersensitivity to any of the components of the NVD003 graft (including the CMRL1066 formulation medium) or hypersensitivity related to other factors in the surgical process for the ICBG graft, such as anesthesia, medications, suture materials or fixation devices.\n11. Participant has received any investigational product (including a device) within 60 days before enrollment in the study.\n12. Participant would be concurrently enrolled in another clinical study while participating in this study.\n13. Participant has any clinically significant hematologic, renal, hepatic, and coagulation laboratory abnormalities (i.e., complete blood count, prothrombin time/international normalized ratio, Chem-7, liver function tests, etc.).\n14. Participant or participant's parent(s)/legal guardian(s) have an unstable condition (e.g., psychiatric disorder, a recent history of substance abuse) or is otherwise thought to be unreliable or incapable of complying with the requirements of the protocol.","locations":[{"facility":"Phoenix Children's Hospital, Inc.","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University Health","city":"Loma Linda","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LifeBridge Health - International Center for Limb Lengthening","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc ASBL (CUSCL)","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Amiens-Picardie","city":"Amiens","state":"Picardie","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Déu","city":"Esplugues de Llobregat","state":"","country":"Spain","status":"WITHDRAWN","lat":null,"lon":null}],"contacts":[{"name":"Judy Ashworth, MD","phone":"224-713-6154","email":"clinical@novadip.com"},{"name":"Lola TOME","phone":"+447468479913","email":"regulatory@novadip.com"}],"primaryOutcomes":["To assess the efficacy of NVD003 for the surgical treatment of CPT in pediatric participants"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","loma-linda-california","baltimore-maryland","rochester-minnesota","brussels-belgium","amiens-france","esplugues-de-llobregat-spain"],"enrichment":{"headline":"Phase 3: testing NVD003 for Congenital Pseudarthrosis of Tibia","inPlainEnglish":"This study wants to assess the how well it works and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.","whoItsFor":["Ages any to 17 Years","Participant is of any sex, ≤17 years of age","Participant has been diagnosed with CPT (with or without NF1)","Participant has a non-healing Paley type 3 or 4 diaphyseal fracture.4","Participant is a candidate for surgical treatment using an internal fixation approach (intramedullary rod) based on CPT fracture status and general health status","Participant has serology and molecular test results at Visits 1 and 2 excluding the presence of human T-cell lymphoma virus, human immunodeficiency virus, hepatitis B virus, hepatitis C virus, and syphilis","Participant can provide an adequate ATC sample volume","Participant weighs ≥5 kg/11 lb at Screening and on Day 1"],"whoShouldSkip":["Participant has bilateral CPT","Participant has evidence of plexiform neurofibroma of any size or nodular fibroma ≥1.2 inches/3 cm on the ipsilateral leg","Participant has a clinically significant infection at the fracture site or systemic infection","Participant's CPT fracture involves the metaphysis (i.e., not limited to the diaphysis)","Participant has a CPT fracture, for which the surgeon intends to use an external fixation system (e.g., Ilizarov, Taylor spatial frame, rail, etc.) instead of, or in addition to, internal fixation","Participant has an autoimmune disease, with the exception of well-controlled type 1 diabetes or autoimmune thyroid disorders","Participant has an active (malignant) tumor"],"whatHappens":"If you join, the listed intervention(s) are NVD003, or Iliac Crest Bone Graft. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of NVD003 in pediatric participants with unilateral Congenital Pseudarthrosis of the Tibia (CPT) compared with iliac crest bone graft (ICBG) at 12 months post graft surgery.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 12 people at 7 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.030Z"},{"nctId":"NCT07113184","title":"Randomized a Clinical Trial With Medical Device in Acute Ischemic Stroke","officialTitle":"DUAL VERSUS SINGLE STENTRIEVER FOR RECANALIZATION IN ACUTE ISCHEMIC STROKE: THE RANDOMIZED DOUBLE UP TRIAL","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Instituto de Investigación Marqués de Valdecilla","sponsorClass":"OTHER","summary":"This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.","conditions":["Acute Ischemic Stroke"],"keywords":["Acute ischemic stroke","mechanical thrombectomy","dual stentriever","mTICI","first pass effect","randomized trial"],"interventions":[{"type":"DEVICE","name":"dual sr"},{"type":"DEVICE","name":"single sr"}],"enrollment":220,"startDate":"2026-03-01","completionDate":"2027-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18\n* NIHSS ≥ 6\n* mRS ≤ 1\n* Proximal anterior circulation occlusion\n* ASPECTS \\> 6\n* Informed consent\n\nExclusion Criteria:\n\n* Absence of occlusion\n* Posterior circulation stroke\n* Carotid dissection or tandem stenosis requiring treatment\n* Severe comorbidities or contraindications to imaging contrast","locations":[{"facility":"Hospital de Burgos","city":"Burgos","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional de Málaga","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario de Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital universitario marques de valdecilla","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Time takes in achieving complete reperfusion after a single thrombectomy pass."],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["burgos-spain","m-laga-spain","salamanca-spain","santander-spain"],"enrichment":{"headline":"Not a traditional drug phase: dual sr for Acute Ischemic Stroke","inPlainEnglish":"This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.","whoItsFor":["Ages 18 Years to any","Proximal anterior circulation occlusion"],"whoShouldSkip":["Absence of occlusion","Posterior circulation stroke","Carotid dissection or tandem stenosis requiring treatment","Severe comorbidities or contraindications to imaging contrast"],"whatHappens":"If you join, the listed intervention(s) are dual sr, or single sr. The registry lists allocation as randomized. This study seeks to provide high-quality evidence on the potential benefits of the dual stentriever approach, potentially informing future clinical guidelines and improving outcomes in patients with anterior circulation large vessel occlusion strokes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 220 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.208Z"},{"nctId":"NCT07113223","title":"Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)","officialTitle":"Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms: a Pragmatic Randomized Clinical Trial (DECISION)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Idoven 1903 S.L.","sponsorClass":"INDUSTRY","summary":"The DECISION trial aims to evaluate the efficacy of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk.\n\nThis multicenter, pragmatic, randomized clinical trial involves two groups: patients receiving AI-assisted ECG analysis and those undergoing standard ECG evaluation. The study's primary analysis will compare the diagnostic performance of AI-assisted ECG versus standard ECG using sensitivity, specificity, and predictive value metrics. Secondary analyses will evaluate healthcare resource utilization, clinical outcomes, and usability feedback from healthcare providers. Results will inform the potential integration of AI-assisted ECG in routine primary care workflows for earlier HF detection and better resource allocation.","conditions":["Heart Failure","Cardiovascular Risk Factors"],"keywords":["Heart Failure","Artificial Intelligence","Electrocardiogram (ECG)","Primary Care","Diagnostic Tools","Cardiology","Electrocardiography","Risk Stratification"],"interventions":[{"type":"DEVICE","name":"Willem™ platform ECG assessment"}],"enrollment":1968,"startDate":"2025-07-23","completionDate":"2027-03","sex":"ALL","minAge":"65 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with Suspected HF (Group S):\n\n  * Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative).\n  * Age over 65 years (i.e., 65 included).\n  * Presence of symptoms and/or signs typical of Heart Failure (defined by the European Society of Cardiology, ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations.\n* Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R):\n\n  * Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative).\n  * Age over 65 years (i.e., 65 included).\n  * Absence of symptoms and/or signs typical of Heart Failure (defined by the ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations.\n  * Presence of at least 1 ACC/AHA Heart Failure risk factor, including hypertension, cardiovascular disease (atrial fibrillation, coronary heart disease or stroke), diabetes, obesity, exposure to cardiotoxic agents, genetic variant for cardiomyopathy, or family history of cardiomyopathy that requires an ECG test for any reason in a primary care center or with an indication of a regular health examination where an ECG is included.\n\nExclusion Criteria:\n\n* Unwillingness or inability to sign the written informed consent.\n* Previous Heart Failure diagnosis.\n* Unavailability or suboptimal quality ECG.","locations":[{"facility":"Hospital General Universitario Gregorio Marañón","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Primary Care: Gerencia Asistencial Atención Primaria Madrid","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marqués de Valdecilla","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Region Stockholm","city":"Stockholm","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juan Francisco Delgado Jiménez, MD, PhD","phone":"+34917792640","email":"juan.delgado@salud.madrid.org"}],"primaryOutcomes":["Device performance in patients with suspected Heart Failure"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["madrid-spain","santander-spain","stockholm-sweden"],"enrichment":{"headline":"Not a traditional drug phase: Willem™ platform ECG assessment for Heart Failure","inPlainEnglish":"The DECISION trial aims to measure the how well it works of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk.","whoItsFor":["Ages 65 Years to any","Patients with Suspected HF (Group S):","Age over 65 years (i.e., 65 included)","Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R):","Absence of symptoms and/or signs typical of Heart Failure (defined by the ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations"],"whoShouldSkip":["Previous Heart Failure diagnosis","Unavailability or suboptimal quality ECG"],"whatHappens":"If you join, the listed intervention(s) are Willem™ platform ECG assessment. The registry lists allocation as randomized. The DECISION trial aims to measure the how well it works of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,968 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.444Z"},{"nctId":"NCT07114601","title":"A Study of LY4257496 in Participants With Cancer (OMNIRAY)","officialTitle":"A Phase 1a/b Multicenter, Open-Label Trial to Evaluate Safety, Tolerability, and Dosimetry of LY4257496, a GRPR-Targeted Radioligand Therapy, in Adults With GRPR-Positive Advanced Solid Tumors (OMNIRAY)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate safety, tolerability, and efficacy of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also evaluate the safety, tolerability, and efficacy of LY4257529 to identify cancer with high levels of a protein called GRPR. This is a 2-part study. Participation could last up to 36 weeks or until your tumor progresses.","conditions":["Breast Neoplasms","Colorectal Neoplasms","Prostate Neoplasm","Endometrial Neoplasms","Neoplasm Metastasis","Stomach Neoplasms","Esophageal Neoplasms"],"keywords":["GRPR-positive"],"interventions":[{"type":"DRUG","name":"LY4257496"},{"type":"DRUG","name":"Standard of Care Anticancer Therapies"},{"type":"DIAGNOSTIC_TEST","name":"LY4257529"}],"enrollment":421,"startDate":"2025-08-06","completionDate":"2030-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer.\n* Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following:\n\n  * At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n  * If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases\n* Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging.\n* Must have the following histologically or cytologically confirmed diagnosis:\n\n  * Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer\n  * ER+/HER2+ breast cancer\n  * Esophageal squamous cell carcinoma\n  * Adenocarcinoma of the stomach, gastroesophageal junction, or esophagus\n  * Colorectal carcinoma\n  * Metastatic castration-resistant prostate cancer\n  * Endometrial carcinoma. Carcinosarcoma is eligible. Uterine leiomyosarcoma, adenosarcoma, or endometrial stromal sarcoma is not eligible.\n  * Low-grade papillary serous ovarian cancer\n  * Other non-Central Nervous System (CNS) primary GRPR-positive solid tumors (Cohorts A1 dose escalation and D1 dose expansion only)\n* For participants with breast cancer diagnosis, where possible, ER and HER2 status should be assessed from the most recent tissue biopsy taken at the time of presentation with recurrent or metastatic disease.\n\n  * To fulfill the requirement for ER+ disease by local testing, a tumor must express the ER immunohistochemistry, as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.\n  * HER2 status should be determined by local testing, as defined in the relevant ASCO/CAP Guidelines.\n* Must have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1.\n* Must be able to comply with outpatient treatment, laboratory monitoring, imaging, and required clinic visits for the duration of trial participation.\n\nExclusion Criteria:\n\n* Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted.\n* Has a history of ongoing acute pancreatitis within 1 year of screening.\n* Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow.\n* A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity.\n* Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence.\n* Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:\n\n  * Have positive HBsAg\n  * Are on suppressive antiviral therapy, as allowed per local regulations prior to C1D1\n  * Remain on the same antiviral treatment throughout study, and should follow local standards for continuation of therapy after completion of trial therapy.\n  * Have undetectable HBV DNA ≤14 days of C1D1.\n* Have known active hepatitis C virus (HCV). Exception: Individuals previously treated for HCV if they:\n\n  * Completed curative antiviral therapy.\n  * Have an HCV viral load below the limit of quantification ≤14 days of C1D1 and.\n  * Are positive for anti-HCV antibodies and negative for HCV ribonucleic acid (RNA) before randomization.\n* Have untreated human immunodeficiency virus (HIV) infection. Exception: Individuals who have well-controlled HIV infection/disease and they:\n\n  * Are on a stable and permitted antiretroviral therapy (ART) regimen without changes in drug or dose, for at least 4 weeks prior to C1D1\n  * Have a viral load of \\<400 copies/mL ≤14 days of C1D1.\n  * Have a CD4+ T-cell count ≥350 cells/mL ≤14 days of C1D1.\n  * Have not had an opportunistic infection within the past 12 months.\n* Has an active second malignancy unless in remission with life expectancy greater than 2 years.\n* Has known hypersensitivity to any component or excipient of LY4257496.","locations":[{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles (UCLA)","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University Medical Center","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biogenix Molecular, LLC","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Moffitt","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University School of Medicine - Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BAMF Health Inc.","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University (NYU) Langone Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW (Sammons CC)","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juravinski Cancer Centre","city":"Hamilton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lady Davis Institute for Medical Research Jewish General Hospital","city":"Montreal","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Hospital","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking Union Medical College Hospital of Chinese Academy of Medical Sciences","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Cancer Hospital Airport Hospital","city":"Tianjin","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancerologie de l'Ouest - site St-Herblain","city":"Saint-Herblain","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Erlangen","city":"Erlangen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Essen","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"LMU Klinikum Muenchen-Campus Grosshadern","city":"München","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)","city":"München","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Chiba","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kyoto University Hospital","city":"Kyoto","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital","city":"Osaka","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Quiron Dexeus Barcelona","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"South Texas Accelerated Research Therapeutics (START) Madrid - Hospital Fundacion Jimenez Diaz","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Phase 1a Dose Escalation: Maximum Tolerated Dose of LY4257496","Phase 1a Dose Optimization: Number of Dose Limiting Toxicities of LY4257496","Phase 1b Dose Expansion and Optimization: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)"],"hasResults":false,"conditionSlugs":["stomach-cancer","als"],"drugSlugs":[],"locationSlugs":["duarte-california","santa-monica-california","stanford-california","miami-florida","tampa-florida","atlanta-georgia","boston-massachusetts","detroit-michigan","grand-rapids-michigan","st-louis-missouri","new-york-new-york","pittsburgh-pennsylvania","dallas-texas","houston-texas","hamilton-canada","montreal-canada","toronto-canada","beijing-china","tianjin-china","paris-france","saint-herblain-france","erlangen-germany","essen-germany","m-nchen-germany","chiba-japan","kyoto-japan","osaka-japan","barcelona-spain","madrid-spain"],"enrichment":{"headline":"Phase 1: testing LY4257496 for Breast Neoplasms","inPlainEnglish":"The main purpose of this study is to evaluate safety, tolerability, and how well it works of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer. The study will also measure the safety, tolerability, and how well it works of LY4257529 to identify cancer with high levels of a protein called GRPR.","whoItsFor":["Ages 18 Years to any","Must have histologically or cytologically proven diagnosis of locally advanced, unresectable, or metastatic cancer","Must be assessed by computed tomography (CT)/magnetic resonance imaging (MRI) to confirm at least 1 of the following:","At least 1 measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","If only bone lesions are present without a soft-tissue component, a bone scan or MRI must confirm at least 2 detectable lesions considered to represent active metastases","Must have GRPR-positive disease, defined by investigator assessment of GRPR imaging","Must have the following histologically or cytologically confirmed diagnosis:","Estrogen receptor (ER+)/human epidermal growth factor receptor 2 (HER2-) breast cancer"],"whoShouldSkip":["Phase 1a (Cohort A1 and A2) only: Previously received radiopharmaceutical or radioligand therapy. For participants with prostate cancer, prior ¹⁷⁷Lu-prostate-specific membrane antigen (PSMA) is permitted","Has a history of ongoing acute pancreatitis within 1 year of screening","Previously received any prior hemi-body or whole-body radiotherapy, or prior external beam radiation therapy (EBRT) to greater than 25% of the bone marrow","A bone superscan, defined as a bone scan that demonstrates markedly increased skeletal radioisotope uptake relative to soft tissues in association with absent or faint genitourinary tract activity","Has evidence of ongoing and untreated urinary tract obstruction or unmanageable urinary incontinence","Have known active hepatitis B virus (HBV). Exception: Individuals with chronic HBV if they:","Have positive HBsAg"],"whatHappens":"If you join, the listed intervention(s) are LY4257496, Standard of Care Anticancer Therapies, or LY4257529. The registry lists allocation as randomized. The main purpose of this study is to evaluate safety, tolerability, and how well it works of LY4257496 alone and as part of relevant standard of care (SOC) combination therapy in participants with Gastrin-releasing Peptide Receptor (GRPR)-positive advanced cancer, including but not limited to breast, colorectal, prostate, endometrial, esophageal, gastroesophageal (GE) junction, and gastric cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 421 people at 33 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.983Z"},{"nctId":"NCT07116525","title":"A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter","officialTitle":"Clinical Evaluation of Arrhythmia Mapping With a Paddle-shaped, High-density, Multi-electrode Mapping Catheter (an Exploratory Investigation)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Biosense Webster, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.","conditions":["Scar-related Atrial Tachycardia","Persistent Atrial Fibrillation","Paroxysmal Atrial Fibrillation","Ventricular Tachycardia","Ischemic Ventricular Tachycardia","Non-ischemic Ventricular Tachycardia","Cardiomyopathy","Idiopathic Ventricular Tachycardia","Premature Ventricular Contraction"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter"}],"enrollment":90,"startDate":"2025-09-15","completionDate":"2027-02-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with and candidate for clinically indicated catheter mapping and ablation procedure for the management of ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation (participant having undergone a previous ablation procedure may be included)\n* At least one episode of the targeted arrhythmia (ventricular tachycardia, premature ventricular complex, atrial tachycardia or atrial fibrillation) must have been documented by electrocardiogram (ECG), Holter, loop recorder, telemetry, implanted device, or transtelephonic monitoring within 12 months prior to enrollment\n* Age 18 years or older\n* Signed Patient Informed Consent Form (ICF)\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause\n* Patients requiring left atrial procedures: left atrial size greater than (\\>) 55 millimeter (mm)\n* Left ventricular ejection fraction(LVEF) less than or equal to (\\<=) 25 percentage (%) for participants with ventricular arrhythmia\n* LVEF \\<= 40% for participants with atrial arrhythmia\n* Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter\n* Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)\n* History of blood clotting or bleeding abnormalities (example hypercoagulable state)\n* Myocardial infarction within the past 2 months (60 days)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 12 months (365 days)\n* Uncontrolled heart failure or New York heart association (NYHA) function class IV\n* Implanted with a pacemaker or intracardiac cardiac defibrillator or appendage closure device within the past 6 weeks (42 days)\n* Patients with known untreatable allergy to contrast media\n* Active illness or active systemic infection or sepsis\n* Diagnosed atrial or ventricular myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Participants that have ever undergone a percutaneous or surgical valvular cardiac procedure (that is, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)\n* Participants that currently have Impella or equivalent devices on the procedure date or up to 7 days prior\n* Any cardiac surgery within the past 60 days (2 months) (includes percutaneous coronary intervention \\[PCI\\])\n* Atrial septal closure within the past 6 weeks (42 days)\n* Presence of a condition that precludes vascular access\n* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Categorized as vulnerable population and requires special treatment with respect to safeguards of well-being\n* Concurrent enrollment in an investigational study evaluating another device or drug","locations":[{"facility":"AZ Sint-Jan","city":"Bruges","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jessa Ziekenhuis","city":"Hasselt","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Bordeaux - Hospital Haut-Leveque","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chu Rennes Hopital Pontchaillou","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vilnius University Hospital Santaros Clinics","city":"Vilnius","state":"","country":"Lithuania","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Occurrence of Serious Adverse Events (SAEs) Within 7 Days of Index Procedure Related to the Investigational Catheter When Used for Endocardial Mapping","Occurrence of Completion of All Pre-Ablation Endocardial Mapping Requirements and Any Clinically Indicated Endocardial Mapping"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["bruges-belgium","hasselt-belgium","pessac-france","rennes-france","vilnius-lithuania"],"enrichment":{"headline":"Not a traditional drug phase: Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter for Scar-related Atrial Tachycardia","inPlainEnglish":"This study wants to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.","whoItsFor":["Ages 18 Years to any","Age 18 years or older"],"whoShouldSkip":["Study arrhythmia secondary to reversible cause, or secondary to electrolyte imbalance, thyroid disease, or non cardiac cause","Patients requiring left atrial procedures: left atrial size greater than (\\>) 55 millimeter (mm)","Left ventricular ejection fraction(LVEF) less than or equal to (\\<=) 25 percentage (%) for participants with ventricular arrhythmia","LVEF \\<= 40% for participants with atrial arrhythmia","Documented intracardiac thrombus as detected on imaging within 24 hours prior to insertion of the investigational catheter","Contraindication to anticoagulation (that is, heparin, warfarin, dabigatran)","History of blood clotting or bleeding abnormalities (example hypercoagulable state)"],"whatHappens":"If you join, the listed intervention(s) are Paddle-Shaped, High-Density, Multi-Electrode Mapping Catheter. The registry lists allocation as na. This study wants to assess the safety and feasibility of the investigational catheter for mapping the atrial and ventricular regions of the heart.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.742Z"},{"nctId":"NCT07116967","title":"Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)","officialTitle":"A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis","conditions":["Plaque Psoriasis"],"keywords":["Deucravacitinib","Plaque psoriasis","Cardiovascular risk","PRAGMATYK"],"interventions":[{"type":"DRUG","name":"Deucravacitinib"},{"type":"DRUG","name":"Ustekinumab"}],"enrollment":3040,"startDate":"2025-09-22","completionDate":"2031-01-16","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with moderate-to-severe plaque psoriasis:\n\n  1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;\n  2. Have at least 1 of the following cardiovascular risk factors:\n* Current cigarette smoker\n* Diagnosis of hypertension\n* Diagnosis of hyperlipidemia\n* Diabetes mellitus type 1 or 2\n* History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack\n* Obesity\n* Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.\n\nExclusion Criteria:\n\n* Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.\n* Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.\n* Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).\n* Other protocol define inclusion/exclusion criteria apply.","locations":[{"facility":"Local Institution - 0088","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Medical Dermatology Specialists - Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saguaro Dermatology - Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omni Dermatology","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Dermatology","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0322","city":"Scottsdale","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0188","city":"Scottsdale","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Scottsdale Clinical Trials","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omni Dermatology","city":"Tempe","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials Institute of Northwest Arkansas","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Arkansas Clinical Trials Center (NWACTC), PLLC","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Dermatology & Clinical Research Institute","city":"Encinitas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"T. Joseph Raoof MD Inc","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First OC Dermatology - Fountain Valley","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center For Dermatology Clinical Research, Inc.","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marvel Clinical Research","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Research Associates - Howard Sofen, MD","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wallace Skin & Body Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0411","city":"Northridge","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Cura Clinical Research - 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1","Other protocol define inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Deucravacitinib, or Ustekinumab. The registry lists allocation as randomized. A study to measure the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 3,040 people at 411 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.582Z"},{"nctId":"NCT07118241","title":"A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE","officialTitle":"A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CONTROLLED STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 µG/ML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF SJÖGREN'S RELATED DRY EYE DISEASE","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Lubris Bio Pty Ltd","sponsorClass":"INDUSTRY","summary":"rhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to evaluate the safety and efficacy of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.","conditions":["Sjögren's Syndrome"],"keywords":["Sjogrens Syndrome","Dry Eye"],"interventions":[{"type":"DRUG","name":"Recombinant Human Proteoglycan 4"},{"type":"DRUG","name":"Vehicle Control"}],"enrollment":80,"startDate":"2025-09-17","completionDate":"2026-12-30","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Have the ability to comprehend and provide a signed and dated consent form.\n2. Are 18-75 years at time of consent;\n3. Have been diagnosed with SS for at least 3 months prior to ICF;\n4. Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;\n5. Have been stably using systemic medications for at least one month prior to Visit 1;\n6. Have Global SANDE score ≥ 40;\n7. Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \\< 5 mm;\n8. Have Oxford corneal fluorescein staining grade of ≥ 1 and ≤ 2 in each eye (OD \\& OS both ≥ 1 and ≤ 2);\n9. Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study.\n10. Ability to self-administer study medication and willingness to adhere to the medication regimen.\n\nExclusion Criteria\n\n1. Are currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection;\n2. Have used any topical ocular medications (other than artificial tears), therapeutic medical devices, or undergone ocular surgery within the 30 days prior to Visit 1. Topical ocular medications include cyclosporine, lifitegrast, corticosteroid eye drops, and autologous/serum. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization;\n3. Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4.\n4. Have only one eye;\n5. Are unwilling to adhere to t.i.d. administration of vehicle during run-in;\n6. Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;\n7. Have begun regularly using systemic compounds for SS or SS-related dry eye during the one month prior to Visit 1. Systemic compounds include omega-3 oil (fish oil, flaxseed oil, etc.), systemic corticosteroids, immunosuppressants, and biologics that based on investigator judgment will interfere with the interpretation of the study results.\n8. Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;\n9. Have known hypersensitivity to one of the components of the study or procedural medications;\n10. Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;\n11. Have a history of drug, medication or alcohol abuse or addiction;\n12. Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:\n\n    1. are currently pregnant or,\n    2. have a positive result on the urine pregnancy test at the Screening Visit or,\n    3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,\n    4. are breast-feeding or,\n    5. not willing to use highly effective birth control measures, such as: Hormonal contraceptives - oral, implanted, transdermal, or injected and/or mechanical barrier methods, during the entire course of and 30 days after the study treatment periods;\n13. Are males with a female partner of child bearing potential where:\n\n    1. the male is not surgically sterilized or,\n    2. where the male partner cannot provide information regarding the female partner's child bearing status or,\n    3. where the child bearing status of the female partner does not meet that of Exclusion Criteria 12; however, the female partner of a male participant will not be required meet Exclusion Criteria 12b.\n14. Have a history of a serious physical or psychiatric disorder that, in the investigator's opinion, could prevent compliance with study procedures or affect study participation;\n15. Have any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.","locations":[{"facility":"Sydney Eye Hospital","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univ of New South Wales","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"OTA","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queensland University of Technology","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of the Sunshine Coast","city":"Maroochydore","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Melbourne Hospital","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Melbourne","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Edward CEO","phone":"6193394016","email":"etruitt@lubris.net"}],"primaryOutcomes":["To assess the efficacy of rhPRG4 by looking at the frequency of patients attaining complete resolution of total corneal staining with fluorescein (Oxford Scale) at Day 28"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["sydney-australia","brisbane-australia","maroochydore-australia","melbourne-australia"],"enrichment":{"headline":"Phase 2: testing Recombinant Human Proteoglycan 4 for Sjögren's Syndrome","inPlainEnglish":"RhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to measure the safety and how well it works of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.","whoItsFor":["Ages 18 Years to 80 Years","Have the ability to comprehend and provide a signed and dated consent form","Are 18-75 years at time of consent;","Have been diagnosed with SS for at least 3 months prior to ICF;","Have been using artificial tears as the only topical treatment of SS related dry eye for at least 30 days prior to Visit 1;","Have been stably using systemic medications for at least one month prior to Visit 1;","Have Global SANDE score ≥ 40;","Average VAS score for typical symptoms of dry eye (dryness, foreign body sensation, burning/stinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \\< 5 mm;"],"whoShouldSkip":["Are unwilling to forgo the use of topical medications (other than IMP and limited artificial tear use), medical devices or ocular surgery from Visit 1 through Visit 4","Are unwilling to adhere to t.i.d. administration of vehicle during run-in;","Are unwilling to limit the use of artificial tears to no more than 4 days during run-in;","Are unwilling to maintain a stable regimen of systemic compound use during the duration of the study;","Have known hypersensitivity to one of the components of the study or procedural medications;","Have participated in another clinical study at the same time as the present study or within 30 days of Visit 1;","Have a history of drug, medication or alcohol abuse or addiction;"],"whatHappens":"If you join, the listed intervention(s) are Recombinant Human Proteoglycan 4, or Vehicle Control. The registry lists allocation as randomized. RhPRG4-Sjögren's-002 is a prospective multi-center study conducted in Australia to measure the safety and how well it works of topically-applied rhPRG4 in subjects with Sjögren's related Dry Eye Disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.959Z"},{"nctId":"NCT07121270","title":"Restorative Early Sleep Treatment After the Emergency Department","officialTitle":"Restorative Early Sleep Treatment After the Emergency Department","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Henry Ford Health System","sponsorClass":"OTHER","summary":"The goal of this randomized controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence.\n\nThe main aims are to:\n\n1. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma\n2. Evaluate the impact of sleep-focused CBT delivered early after trauma on sleep disturbance\n3. Evaluate the impact of sleep-focused CBT delivered early after trauma on PTSD symptoms\n\nThe investigators will compare CBT-I and CBT-I\\&N to sleep education control.\n\nParticipants will meet with a provider for 6 weekly sessions via telehealth and complete surveys on the participants' symptoms.","conditions":["Insomnia","Nightmares Associated With Trauma and Stress","Nightmares","PTSD - Post Traumatic Stress Disorder"],"keywords":["CBT-I","Nightmares","Insomnia","Trauma","Sleep Education","PTSD","CBT-I&amp;amp;N","Acute Trauma","RCT","Early intervention","Behavioral sleep medicine","Posttraumatic stress","Trauma-induced insomnia","Cognitive behavioral therapy","Prevention"],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy for Insomnia"},{"type":"BEHAVIORAL","name":"Cognitive Behavioral Therapy for Insomnia and Nightmares"},{"type":"BEHAVIORAL","name":"Sleep Education"},{"type":"BEHAVIORAL","name":"Sleep Education enhanced with Nightmare Education"}],"enrollment":80,"startDate":"2025-03-17","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Michigan residents treated at Henry Ford Hospital\n* Fluent in English\n* Age 18 years or older\n* Presenting to ED following exposure to Criterion A trauma (exposure to actual or threatened death, serious injury, or sexual violence) characterized by interpersonal violence (defined as any victimization experience that involved being intentionally and directly harmed by another individual\n* i.e., assault with a weapon, physical assault, or sexual assault\n* Qualifying trauma occurred within the past \\~72hr\n* Hospital Mental Health Risk Screen score ≥ 10 (indicating at-risk for developing mental health problems)\n* Patient is not in any other cognitive behavioral treatment with a master's level clinician or above\n* Patient is appropriate for outpatient treatment and level of acuity does not require inpatient treatment\n\nExclusion criteria:\n\n* Presenting to ED for non-interpersonal trauma\n* Defined as any experience that does not involve being intentionally and directly harmed by another individual\n* i.e., falls, motor vehicle collisions, self-injury or suicide attempt\n* Current or past history of schizophrenia or other psychoses based on EMR data\n* Current or past PTSD based on EMR data\n* Unmanaged mania or bipolar disorder based on EMR data\n* Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder\n* Active suicidality:\n* Presented to ED with self-inflicted injury or attempted suicide\n* Current suicidal ideation with intent (with or without a specific plan) within past month\n* Suicide attempts during the past three months\n* Current homicidal ideation\n* Active substance withdrawal\n* Pregnant\n* Evidence of a current or past traumatic brain injury or loss of consciousness due to head injury at the time of trauma based on EMR data\n* No cell phone, email address, or stable home address\n* Evidence or risk of ongoing traumatic exposure (e.g., domestic violence)\n* Adults in police custody or Dept of Correction patients\n* Evidence of altered mental status, inability to understand study procedures/risks, or otherwise unable to give informed consent\n* Admission to an intensive care unit, admission or surgery, medical instability or hemodynamic compromise\n* Currently engaged in cognitive behavioral treatment\n* Currently living in a nursing home\n* Currently working non-standard shifts (outside the hours 7am - 6pm)","locations":[{"facility":"Henry Ford Hospital System","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anthony Reffi, PhD","phone":"3138053080","email":"areffi1@hfhs.org"},{"name":"Lily Jankowiak, BS","phone":"3139165179","email":"ljankow2@hfhs.org"}],"primaryOutcomes":["Session Attendance","Retention Rate","Patient Satisfaction","Change in Insomnia Symptoms (Insomnia Severity Index)"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["detroit-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Cognitive Behavioral Therapy for Insomnia for Insomnia","inPlainEnglish":"The goal of this randomly assigned controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence. Test the acceptability, feasibility, and satisfaction of sleep-focused CBT delivered early after trauma 2.","whoItsFor":["Ages 18 Years to any","Michigan residents treated at Henry Ford Hospital","Age 18 years or older","i.e., assault with a weapon, physical assault, or sexual assault","Qualifying trauma occurred within the past \\~72hr","Hospital Mental Health Risk Screen score ≥ 10 (indicating at-risk for developing mental health problems)","Patient is not in any other cognitive behavioral treatment with a master's level clinician or above","Patient is appropriate for outpatient treatment and level of acuity does not require inpatient treatment"],"whoShouldSkip":["Presenting to ED for non-interpersonal trauma","Defined as any experience that does not involve being intentionally and directly harmed by another individual","i.e., falls, motor vehicle collisions, self-injury or suicide attempt","Current or past history of schizophrenia or other psychoses based on EMR data","Current or past PTSD based on EMR data","Unmanaged mania or bipolar disorder based on EMR data","Active, untreated substance use disorder based on EMR data other than alcohol use disorder, cannabis use disorder, nicotine use disorder, or tobacco use disorder"],"whatHappens":"If you join, the listed intervention(s) are Cognitive Behavioral Therapy for Insomnia, Cognitive Behavioral Therapy for Insomnia and Nightmares, or Sleep Education. The registry lists allocation as randomized. The goal of this randomly assigned controlled trial is to pilot the virtual delivery of cognitive behavioral therapy for insomnia (CBT-I) and nightmares (CBT-I\\&N) via telehealth as an early intervention for treating posttraumatic sleep disturbance in acute trauma patients exposed to interpersonal violence.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Detroit. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.408Z"},{"nctId":"NCT07121972","title":"Mirai-MRI: Validation of AI Models for Breast Cancer Risk","officialTitle":"Mirai-MRI: Multi-site Prospective Validation of AI Models for Breast Cancer Risk","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"This is a multi-center, single arm trial to evaluate the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.","conditions":["Cancer Risk","Breast Cancer Risk"],"keywords":["Screening","BI-RADS"],"interventions":[{"type":"PROCEDURE","name":"Magnetic resonance imaging (MRI)"},{"type":"DEVICE","name":"Artificial Intelligence (AI)"}],"enrollment":400,"startDate":"2025-11-03","completionDate":"2027-01-31","sex":"FEMALE","minAge":"40 Years","maxAge":"89 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2.\n2. Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk).\n3. Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images.\n4. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Screening mammogram that is assessed as BI-RADS 0 for technical recall.\n2. Contraindications for MRI:\n\n   1. Metallic foreign body in the eye.\n   2. MRI unsafe implants and/or medical devices.\n   3. Adverse reaction to a (gadolinium-based) contrast agent in the past.\n   4. Pregnant women.\n   5. Claustrophobia.\n   6. Exceeds site specific size and/or weight limit for MRI.\n3. If the participant meets site-specific criteria for screening estimated glomerular filtration rate (eGFR) prior to MRI, participants with severely impaired renal function (GFR \\< 30 mL/min) will be excluded. According to University of California, San Francisco's policy for MRI with contrast (gadolinium-containing), serum creatinine with calculation of eGFR should be obtained within 6 weeks of the MRI study for participants with any of the following risk factors:\n\n   1. History of \"kidney disease\" as an adult, including renal tumor or transplant.\n   2. Diabetes treated with insulin or other prescribed medications.\n   3. Hypertension (high blood pressure) requiring medication.\n   4. Multiple myeloma.\n   5. Solid organ transplant.\n   6. History of severe hepatic disease/liver transplant/pending liver transplant.","locations":[{"facility":"University of California, San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Massachusetts Memorial Medical Center","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tiffany Tran","phone":"877-827-3222","email":"tiffany.tran3@ucsf.edu"}],"primaryOutcomes":["Cancer detection rate (CDR)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["san-diego-california","san-francisco-california","chicago-illinois","worcester-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Magnetic resonance imaging (MRI) for Cancer Risk","inPlainEnglish":"This is a multi-center, single arm trial to measure the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment. Mirai is an accurate cancer risk model based on full-resolution mammograms.","whoItsFor":["Ages 40 Years to 89 Years","Women only","All asymptomatic participants assigned female at birth, ages 40-89 years old with screening mammography assessed as Breast Imaging Reporting and Data System (BI-RADS) 1, BI-RADS 2, or initial BI-RADS 0 with subsequent diagnostic mammogram assessed as BI-RADS 1 or BI-RADS 2","Screening mammogram assessed as high-risk by Mirai (top 3 percentile of 2-year risk)","Availability of a routine screening mammogram report, along with a subsequent diagnostic mammogram report if applicable, and access to the corresponding Digital Imaging and Communications in Medicine (DICOM) images"],"whoShouldSkip":["Screening mammogram that is assessed as BI-RADS 0 for technical recall","Contraindications for MRI:","Metallic foreign body in the eye","MRI unsafe implants and/or medical devices","Adverse reaction to a (gadolinium-based) contrast agent in the past","Exceeds site specific size and/or weight limit for MRI","History of \"kidney disease\" as an adult, including renal tumor or transplant"],"whatHappens":"If you join, the listed intervention(s) are Magnetic resonance imaging (MRI), or Artificial Intelligence (AI). The registry lists allocation as na. This is a multi-center, single arm trial to measure the cancer detection rate of supplemental screening magnetic resonance imaging (MRI) in participants who are high-risk by Mirai-MRI assessment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at 4 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.955Z"},{"nctId":"NCT07122401","title":"Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism","officialTitle":"A Multicenter, Randomized, Double-blind, Double-dummy, Phase III Study to Evaluate the Efficacy and Safety of MT1013 Versus Cinacalcet as Active Control in Secondary Hyperparathyroidism Patients on Maintenance Dialysis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Shaanxi Micot Pharmaceutical Technology Co., Ltd.","sponsorClass":"INDUSTRY","summary":"MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.","conditions":["Secondary Hyperparathyroidism, Chronic Kidney Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"MT1013"},{"type":"DRUG","name":"Cinacalcet"}],"enrollment":424,"startDate":"2025-09-30","completionDate":"2026-11-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;\n2. Male or female, at least 18 years old, 18 kg/m\\^2 ≤BMI≤35 kg/m\\^2;\n3. Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；\n4. Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);\n5. Subjects must have a confirmed diagnosis of Secondary Hyperparathyroidism (SHPT), with a mean pre-dialysis serum intact parathyroid hormone (iPTH) level ≥ 400 pg/mL (42.4 pmol/L), based on measurements from two non-consecutive days before dialysis, within 14 days prior to randomization;\n6. Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \\<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements.\n\nExclusion Criteria:\n\n1. Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;\n2. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;\n3. New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP).\n4. QTcF interval \\>470 ms in males or \\>480 ms in females on screening ECG, or other clinically significant ECG abnormalities as determined by the Investigator (e.g., third-degree atrioventricular block, sick sinus syndrome, multifocal frequent ventricular premature contractions, ventricular tachycardia, atrial fibrillation, etc.).\n5. Subjects with severe uncontrolled hypertension during the screening period are excluded, defined as systolic blood pressure \\>180 mmHg and/or diastolic blood pressure \\>110 mmHg despite optimal medical therapy prior to enrollment (excluding transient blood pressure abnormalities during dialysis).\n6. History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;\n7. Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;\n8. Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study.","locations":[{"facility":"Zhongshan Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaoqiang Ding, MD","phone":"021-31587862","email":"DING.XIAOQIANG@ZS-HOSPITAL.SH.CN"}],"primaryOutcomes":["Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH)","Percentage of participants with > 30% reduction from baseline in mean iPTH"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 3: testing MT1013 for Secondary Hyperparathyroidism, Chronic Kidney Disease","inPlainEnglish":"MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, double-dummy phase III clinical study being conducetd to measure the how well it works and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis.","whoItsFor":["Ages 18 Years to any","Male or female, at least 18 years old, 18 kg/m\\^2 ≤body-mass index (BMI)≤35 kg/m\\^2;","Receiving regular maintenance dialysis 3 times a week for at least 12 weeks prior to screening；","Dialysate calcium concentration≥1.25 mmol/L (2.5 mEq/L);","Within 14 days prior to randomization, subjects must have serum calcium levels (measured pre-dialysis, or corrected serum calcium if albumin \\<40 g/L) ≥ 8.4 mg/dL (2.1 mmol/L) on two non-consecutive pre-dialysis measurements"],"whoShouldSkip":["Underwent parathyroidectomy within 6 months prior to screening, or anticipated parathyroidectomy, ablation or radiation during the study;","Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;","New York Heart Association (NYHA) Class III or IV heart failure within 3 months prior to screening; Symptomatic arrhythmia within 6 months prior to screening; History of torsades de pointes (TdP)","History of seizure within 1 year prior to screening, or currently receiving treatment for seizure disorders;","Received oral cinacalcet or ivocalcet within 14 days prior to screening, or received Etelcalcetide injection treatment within 4 months prior to screening;","Any other condition that, in the Investigator's judgment, would make the subject unsuitable for participation in this study"],"whatHappens":"If you join, the listed intervention(s) are MT1013, or Cinacalcet. The registry lists allocation as randomized. MT1013 is a first-in-class dual-target agonist.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 424 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.498Z"},{"nctId":"NCT07122700","title":"Evaluation of Non-Invasive Tests for Metabolic Liver Disease","officialTitle":"Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) Study 2.0 - An FNIH Biomarkers Consortium Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Foundation for the National Institutes of Health","sponsorClass":"OTHER","summary":"The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.","conditions":["Metabolic Associated Fatty Liver Disease","Metabolic Associated Steatotic Liver Disease","Cirrhosis, Liver","NASH","Liver Fibrosis","Liver Fat","Liver Steatoses","Liver Inflammation"],"keywords":[],"interventions":[],"enrollment":400,"startDate":"2025-05-13","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged \\> 18 years and \\< 75 years\n4. Participants must exhibit some manifestations of metabolic dysregulation. Either:\n\nA. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]\n\n1\\. body mass index (BMI) of \\> 25 kg/m2 2. waist circumference: i. \\> 102 cm for men ii. \\> 88.9 cm for women 3. fasting triglyceride concentration \\> 150 mg/dL i. or ongoing treatment with triglyceride lowering medication 4. HDL-cholesterol concentration: i. \\< 40 mg/dL for men ii. \\< 50 mg/dL for women iii. or ongoing treatment with cholesterol lowering medication. 5. fasting glucose concentration \\> 100 mg/dL 6. either semi-recumbent or supine blood pressure systolic \\> 130 mmHg and/ or diastolic \\> 85 mmHg i. or ongoing treatment with antihypertensive medication. 5. FIB-4 \\> 1.3 (age \\< 65 years) and \\> 2.0 (age \\> 65 years) 6. Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration\n\nExclusion Criteria:\n\n1. Known history or evidence of other forms of chronic liver disease other than MASLD/MASH including but not limited to viral hepatitis B or C, autoimmune liver disease, primary biliary cholangitis, primary sclerosing cholangitis, Wilson disease, hemochromatosis, drug-induced liver disease, conditions involving bile duct obstructions, liver cancer, past history of HCC or HCC treatment, listed for or history of liver transplantation, prior resection of liver, etc.\n2. Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage\n3. Circulating Alanine aminotransferase (ALT)\\> 5xULN\n4. Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol.\n\n   * A standard alcoholic drink is any drink that contains about 14 g of pure alcohol, such as 12 fluid ounces of regular beer 8-10 fluid ounces of malt liquor or flavored malt beverages such as hard seltzer 5 fluid ounces of table wine 3-4 fluid ounces of fortified wine such as sherry or port 2-3 fluid ounces of cordial liqueur or aperitif 1.5 fluid ounces (a single jigger or shot) of brandy, cognac, or distilled spirits such as gin, rum, tequila, vodka, whiskey, etc.\n   * Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:\n\n   Women\n   * \\>1 standard drink per day and/or\n   * \\>14 standard drinks per week Men\n   * \\>2 standard drinks per day and/or\n   * \\>21 standard drinks per week in men\n\n     * An Alcohol Use Disorders Identification Test (AUDIT) score of 7 or higher\n     * A PEth test score of ≥ 20ng/ml.\n5. In the opinion of the investigator, any contraindications to liver biopsy including but not limited to having significant uncorrected coagulopathy or thrombocytopenia, on chronic anticoagulation with Direct Oral Anticoagulants (DOACs), or on low dose heparin or Warfarin.\n6. Uncontrolled systolic blood pressure \\> 180 mmHg and diastolic blood pressure \\> 120 mmHg at screening. Blood pressure will be obtained after at least 10 minutes of resting in a semi-recumbent or supine position.\n7. Any systemic disease that in the opinion of the investigator precludes inclusion of the patient in the trial\n8. Unable or unwilling to provide informed consent\n9. Unwilling to undergo liver biopsy procedure\n10. Unable or unwilling to comply with requirements for study procedures (such as fasting)\n11. Unable to perform study procedures in the opinion of the investigator\n12. Participants who are unwilling or unable (e.g. due active implants such as pacemaker or having a waist diameter (calculated as: diameter = circumference / π) 70cm, unless a wide-bore MRI machine is available) to undergo MRI procedures.\n13. Pregnancy or planned pregnancy within 4 months of screening.\n14. Participation in another clinical trial within 30 days, or dosing with an investigational agent within 90 days prior to signing the ICF for this study.","locations":[{"facility":"Clinical Pharmacology of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio Clinical Trials","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Surgical Hospital","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Clinical Trials","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Geraldine Dacpano","phone":"908-650-1353","email":"gdacpano@ergclinical.com"},{"name":"Clay Dehn","phone":"908-484-4110","email":"cdehn@ergclinical.com"}],"primaryOutcomes":["Detection of At-Risk MASH","Fibrosis Staging","Liver Fat Content Monitoring","Diagnostic Enrichment","Exploratory Biomarkers"],"hasResults":false,"conditionSlugs":["fatty-liver"],"drugSlugs":[],"locationSlugs":["miami-florida","columbus-ohio","bellaire-texas","san-antonio-texas"],"enrichment":{"headline":"Evaluation of Non-Invasive Tests for Metabolic Liver Disease","inPlainEnglish":"The Non-Invasive Biomarkers for Metabolic Liver Disease (NIMBLE) study is a comprehensive, multi-year collaborative effort to standardize, validate and advance the regulatory qualification of blood- and imaging-based biomarkers to diagnose and stage Metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). MASH is characterized by liver inflammation accompanied by simultaneous fat accumulation in the liver.","whoItsFor":["Ages 18 Years to 75 Years","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged \\> 18 years and \\< 75 years","Participants must exhibit some manifestations of metabolic dysregulation. Either:","A. Physician-diagnosed T2DM for at least 90 days with HbA1c \\> 6.5 and antidiabetic therapy, if any, stable for at least 90 days prior to screening or B. At least any one of the following six metabolic syndrome criteria \\[6\\]"],"whoShouldSkip":["Current or past evidence of decompensated liver disease defined by overt ascites that is clinically obvious and requires diuretic therapy, overt encephalopathy requiring therapy or history of variceal hemorrhage","Circulating Alanine aminotransferase (ALT)\\> 5xULN","Ongoing or recent (within the last two years prior to screening) consumption of significantly greater than moderate amounts of alcohol","Significantly greater than moderate alcohol consumption is defined as on average over a 2-year period prior to screening:","\\>1 standard drink per day and/or","\\>14 standard drinks per week Men","\\>2 standard drinks per day and/or"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.154Z"},{"nctId":"NCT07123090","title":"A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma","officialTitle":"A Phase 2 Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma - SPARCC","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Stephanie Berg","sponsorClass":"OTHER","summary":"The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).\n\nThe name of the study drugs involved in this research study is:\n\n* Sasanlimab (a type of monoclonal antibody)\n* Palbociclib (a type of kinase inhibitor)\n* Axitinib (a type of Vascular endothelial growth factor inhibitor)","conditions":["Metastatic Renal Cell Carcinoma","Metastatic Renal Cancer","Renal Cell Carcinoma","Advanced Clear Cell Renal Cell Carcinoma","Kidney Cancer","Translocation Renal Cell Carcinoma"],"keywords":["Metastatic Renal Cell Carcinoma","Metastatic Renal Cancer","Renal Cell Carcinoma","Advanced Clear Cell Renal Cell Carcinoma","Kidney Cancer","Translocation Renal Cell Carcinoma","ccRCC","tRCC"],"interventions":[{"type":"DRUG","name":"Sasanlimab"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Axitinib"}],"enrollment":25,"startDate":"2025-11-24","completionDate":"2027-10-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible.\n\n  * a. For tRCC please refer to the following for eligibility definitions:\n\n    * i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable.\n    * ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded.\n  * b. A formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy obtained during screening will be required (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides from a primary or metastatic tumor resection or biopsy) can be provided if the following criteria are met:\n\n    * i. The biopsy or resection was performed within 1 year of registration AND\n    * ii. The patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and registration onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then 15 unstained slides (10 minimum) will be acceptable\n  * c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable.\n* Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease.\n* Age ≥ 18 years.\n* ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).\n* Normal organ and marrow function as defined below:\n\n  * a. Absolute neutrophil count ≥1.5×109/L\n  * b. Platelets ≥100×109/L\n  * c. Hemoglobin ≥9g/dL (RBC transfusions allowed)\n  * d. Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) with the following exception: patients with known Gilbert disease should have a total serum bilirubin ≤ 3 x ULN\n  * e. AST(SGOT)/ALT(SGPT) ≤1.5 × ULN\n  * f. Creatinine clearance ≥30 mL/min according to the CKD-EPI equation. (APPENDIX C)\n  * g. Urine protein \\<1+ by urinalysis; If ≥1+ protein or otherwise suggestive of any proteinuria above a trace amount (per local institutional standards), a random urine protein and creatinine ratio (UPCR) should be collected. A 24-hour urine collection can also be utilized for direct measurement. When multiple modalities are used, the 24-hour urine measurement takes precedence over the random UPCR; refer to section 6.2 for further guidance.\n* Women of child-bearing potential and men must agree to use adequate contraception (intrauterine device or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. A negative pregnancy serum test should be obtained within 7 days of therapy initiation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation. Participants treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of sasanlimab, axitinib and palbociclib administration.\n* Ability to swallow oral medications.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Treatment with the following prior therapies:\n\n  * a. Prior systemic therapy for advanced or metastatic RCC.\n  * b. Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred within 12 months of last dose of such therapy. Treatment with an immune checkpoint inhibitor in the adjuvant setting is allowed providing more than 12 months have elapsed since last dose or completion of therapy.\n  * c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways).\n  * d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed).\n\n    e. Prior therapy with any CDK4/6 inhibitor.\n* Participants with untreated brain metastases. Participants with metastatic CNS tumors may participate in this trial, if the participant is ≥ 4 weeks from therapy completion (incl. radiation and/or surgery), is clinically stable at the time of study entry and is not receiving corticosteroid therapy \\>10 mg/day prednisone equivalents. A repeat MRI or CT brain to show stability is required.\n* Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration.\n* Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1.\n* Major surgery/surgical procedures within the past 4 weeks prior to registration.\n* The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease - also see 3.2.22, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\<30ml/min\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea).\n* Current or prior use of immunosuppressive medication within 7 days prior to registration, except the following:\n\n  * a. Intranasal, inhaled, topical steroids, or local steroid injections (eg. intra-articular injection).\n  * b. Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent.\n  * c. Steroids as premedication for hypersensitivity reactions (eg. CT scan premedication).\n* Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3) or any history of anaphylaxis.\n* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agents. Patients with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroidism not requiring immunosuppressive treatment are eligible.\n* Vaccination within 4 weeks of the first dose of sasanlimab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza or shingles vaccines). Note, the COVID19 vaccine is not a live vaccine and permitted.\n* Grade ≥3 hemorrhage within 4 weeks of registration.\n* Patient with active systemic bacterial infection (requiring IV antibiotics at the time of initiating study treatment), fungal infection, or detectable viral infection. Patients with known viral infection (such as HIV) are excluded given the potential for interactions between antiretroviral agents and palbociclib and axitinib, and the potential for increased risk of life-threatening infection with therapy that is myelosuppressive. If patients are not known to have HIV, a HIV test is required prior to registration.\n* Patients with known Hepatitis B or Hepatitis C infection are excluded only if there is evidence of active infection (detectable Hepatitis B surface antigen, detectable HBV DNA, or detectable Hepatitis C RNA).\n* Prior allogenic or autologous stem cell or any solid organ transplant.\n* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of oral drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).\n* Participants who are currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant. Therapeutic use of low molecular weight heparin and factor Xa inhibitors (eg. apixaban, rivaroxaban) is permitted.\n* Other malignancy diagnosed within 2 years of treatment start unless negligible risk of metastases or death according to the investigator (included but not limited to carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, ductal carcinoma in situ of the breast, non-muscle invasive urothelial carcinoma, or other malignancy not deemed to impact patients 5-year life expectancy).\n* Has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), myocarditis, sudden cardiac arrest.\n* Has had any major cardiovascular event within 6 months prior to treatment start, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic event or New York Heart Association Class III or IV heart failure.\n* Ongoing cardiac dysrhythmias of NCI CTCAE Grade ≥2 or history of long QTC syndrome. Any history of myocarditis.\n* History of interstitial lung disease or other restrictive lung disease, as well as history of symptomatic respiratory condition considered clinically significant by the investigator. Individuals with a history of radiotherapy to the thorax and any history of pneumonitis will be excluded.\n* Current or past tobacco users with a history of cigarette smoking greater than 30 pack-yrs (i.e., # of packs of cigarettes smoked per day × # of years patient has smoked \\> 30).\n* Participants with a known hypersensitivity to the study compounds or to its excipients.\n* Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors, including their administration within 7 days prior to treatment start (eg. Grapefruit juice or grapefruit/grapefruit-related citrus fruits \\[eg. Seville oranges, pomelos\\], ketoconazole, miconazole, itraconazole, voriconazole, , clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan). The topical use of these medications (if applicable), such as 2% ketoconazole cream, is allowed.\n* Current use or anticipated need for drugs that are known strong CYP3A4/5 inducers, including their administration within 14 days prior to treatment start (eg. Phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, 23albociclib, clevidipine, St John's wort).\n* Participants who have taken herbal medications within 7 days prior to treatment start. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng.\n* Females that are pregnant or breastfeeding.\n* Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephanie Berg, DO","phone":"617-632-6328","email":"stephaniea_berg@dfci.harvard.edu"},{"name":"Bradley McGregor, MD","phone":"1-877-DF-TRIAL","email":"Bradley_McGregor@DFCI.HARVARD.EDU"}],"primaryOutcomes":["Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: testing Sasanlimab for Metastatic Renal Cell Carcinoma","inPlainEnglish":"The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC). The name of the study drugs involved in this research study is: * Sasanlimab (a type of monoclonal antibody) * Palbociclib (a type of kinase inhibitor) * Axitinib (a type of Vascular endothelial growth factor inhibitor)","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed unresectable advanced or metastatic renal cell carcinoma with a clear cell component or translocation renal cell carcinoma. Patients with clear cell carcinoma and sarcomatoid histology are eligible","a. For tRCC please refer to the following for eligibility definitions:","i. TFE3 (Xp11.2) translocation RCC: confirmed by IHC; however, FISH should be utilized if IHC is not optimal (ie, conclusive) or unavailable","ii. TFEB rearranged RCC: confirmed by FISH; TFEB amplified tumors are excluded","i. The biopsy or resection was performed within 1 year of registration AND","c. Availability of an archival FFPE tumor tissue block from primary diagnosis specimen (if available and not provided per above). If an FFPE tissue block cannot be provided as per documented regulations, then 15 unstained slides (10 minimum) will be acceptable","Measurable disease as per RECIST 1.1. See Section 11 for the evaluation of measurable disease"],"whoShouldSkip":["Treatment with the following prior therapies:","a. Prior systemic therapy for advanced or metastatic RCC","c. Prior treatment with any immunotherapeutic agent (IL-2, IFN-α, anti-PD(L)-1, anti-CTLA-4, or any other antibody or drug targeting T-cell co-stimulation or immune checkpoint pathways)","d. Prior therapy with axitinib or other therapies targeting VEGF pathway in the metastatic setting (adjuvant therapy is allowed)","e. Prior therapy with any CDK4/6 inhibitor","Wide field radiation therapy ≤ 2 weeks prior to treatment start. Prior palliative radiotherapy to metastatic non-target lesion(s) is permitted if completed at least 48hrs prior to patient registration","Untreated deep vein thrombosis or pulmonary embolism, or event of deep vein thrombosis or pulmonary embolism within 2 weeks of treatment start. Patient should be on at least 1 week of anticoagulation before C1D1"],"whatHappens":"If you join, the listed intervention(s) are Sasanlimab, Palbociclib, or Axitinib. The registry lists allocation as na. The goal of this research study is to evaluate how well and safely the study drugs sasanlimab, palbociclib, and axitinib work for treatment of participants with advanced clear cell renal cell carcinoma (ccRCC) or translocation renal cell carcinoma (tRCC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 25 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.729Z"},{"nctId":"NCT07123467","title":"Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder","officialTitle":"Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Wayne State University","sponsorClass":"OTHER","summary":"This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.","conditions":["Generalized Anxiety Disorder (GAD)","Anxiety Disorders"],"keywords":["Cannabidiol","EPIDIOLEX","Cognitive Behavioral Therapy","Generalized Anxiety Disorder","functional magnetic resonance imaging"],"interventions":[{"type":"DRUG","name":"Low-Dose Cannabidiol"},{"type":"DRUG","name":"Placebo Matched to Moderate-Dose Cannabidiol"},{"type":"DRUG","name":"Moderate-Dose Cannabidiol"},{"type":"DRUG","name":"Placebo Matched to Low-Dose Cannabidiol"}],"enrollment":90,"startDate":"2025-11-03","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Right-handed\n* Age 18-45 years at enrollment\n* Able to consent to the study\n* Agree to adhere to lifestyle considerations throughout study duration\n* Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment\n* Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and/or total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)\n\nExclusion Criteria:\n\n* Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol\n* Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol\n* Risk of harm to self or others that requires immediate intervention\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®\n* Positive drug screen or alcohol breathalyzer\n* Unwilling/unable to sign informed consent document\n* Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),\n* Under 18 or over 45 years of age\n* Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and/or the brain undergoing an acceleration/deceleration movement \\[i.e., whiplash\\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)\n* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and/or a preliminary session in a mock scanner\n* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)\n* Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year\n* Current moderate or severe alcohol/drug use disorder or in the past 8 weeks\n* Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders;\n* GAD-7 score \\< 8\n* Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19)\n* Visual impairment\n* Baseline labs 3 times outside of normal range\n* Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \\< 4 weeks), or intention to start new treatment during this trial\n* Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen)\n* Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness\n* Treatment with another investigational drug or intervention within the past month\n* Difficulty with or inability to comply with the complete clinical trial.","locations":[{"facility":"Wayne State University School of Medicine, Tolan Park Medical Building","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hilary Marusak, PhD","phone":"(313) 577-1278","email":"hmarusak@med.wayne.edu"},{"name":"Christine Rabinak, PhD, MBA","phone":"(313) 577-9875","email":"rabinak@wayne.edu"}],"primaryOutcomes":["Change in dorsomedial prefrontal cortex activation when reappraising negative images"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["detroit-michigan"],"enrichment":{"headline":"Phase 3: testing Low-Dose Cannabidiol for Generalized Anxiety Disorder (GAD)","inPlainEnglish":"This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 45 Years","Age 18-45 years at enrollment","Able to consent to the study","Agree to adhere to lifestyle considerations throughout study duration","Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment","Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and/or total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)"],"whoShouldSkip":["Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and/or task performance and/or interfere with the study protocol","Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol","Risk of harm to self or others that requires immediate intervention","Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®","Positive drug screen or alcohol breathalyzer","Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),","Under 18 or over 45 years of age"],"whatHappens":"If you join, the listed intervention(s) are Low-Dose Cannabidiol, Placebo Matched to Moderate-Dose Cannabidiol, or Moderate-Dose Cannabidiol. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 90 people at Detroit. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.351Z"},{"nctId":"NCT07123727","title":"A Study to Examine Anktiva for the Treatment of COVID-19.","officialTitle":"Single Arm Study to Evaluate the Safety of Nogapendekin Alfa Inbakicept (NAI) in Participants With Long COVID","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"ImmunityBio, Inc.","sponsorClass":"INDUSTRY","summary":"This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.","conditions":["Long COVID","Long COVID Syndrome","Long Covid 19"],"keywords":[],"interventions":[{"type":"DRUG","name":"Anktiva"}],"enrollment":40,"startDate":"2025-09-04","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 and \\< 70 years.\n* History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Those with only suspected but unconfirmed infections are not eligible for this study.\n* Clinical evidence of Long COVID, as confirmed by the Investigator's assessment.\n\n  1. At least 2 symptoms or at least 1 severe symptom as assessed by the study team (see list) that are new or worsened since the time of a SARS-CoV-2 infection, not known to be attributable to another cause upon assessment by the PI. At least 2 symptoms from those listed here must be present: systemic symptoms (eg, fatigue, chills, post-exertional malaise), neurocognitive symptoms (eg, trouble with memory/concentration (\"brain fog\"), headache, dysautonomia/postural orthostatic tachycardia symptoms, dizziness, unsteadiness, neuropathy, sleep disturbance), cardiopulmonary symptoms (eg, chest pain, palpitations, shortness of breath, cough, fainting spells), musculoskeletal symptoms (eg, muscle aches, joint pain), gastrointestinal symptoms (eg, nausea, diarrhea). Although other symptoms (eg, skin rash, hair loss, trouble with smell/taste, genitourinary symptoms) will be recorded and tracked, at least 2 core symptoms listed above must be present. Note: the 2 symptoms can be from within the same category (for example, brain fog and headache) AND\n  2. Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND\n  3. Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND\n  4. At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators.\n* Not currently hospitalized.\n* Body mass index (BMI) 18 to 50 kilograms/meter squared (kg/m2), inclusive, at the time of screening.\n* In otherwise stable health, as assessed by the Investigator within 28 days prior to screening, based on medical history, physical examination, laboratory findings, and vital signs.\n* For male participants,\n\n  a. Participants with partners that are WOCBP are strongly advised to inform their partners and must agree to use effective contraception from study entry (defined as INT1) through 7 months after the last dose of study intervention. Participants with pregnant partners must agree to use condoms during vaginal intercourse from study entry (defined as INT1) through 14 days after the last dose of study intervention administration.\n* For female participants,\n\n  a. A female participant who engages in sexual intercourse with male partners is eligible to participate if she is not pregnant or breastfeeding, and the following conditions applies: i. Is not a WOCBP OR ii. All of the following apply:\n  1. Is a WOCBP and is using a contraceptive method from - 21 days from study entry (defined as INT1), during the study intervention period, and for at least 7 months after the last study intervention administration.\n  2. A WOCBP must have a negative urine pregnancy test within 24 hours prior to all doses of study intervention. If a urine pregnancy test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test must be negative.\n* Willingness and ability to comply with the study protocol. This includes reliable transportation and sufficient time to attend all visits.\n* Written informed consent obtained from participant or participant's legal representative and ability for participant to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study.\n* Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before exiting the study.\n* History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases.\n* Active cardiovascular disease, defined as known prior:\n\n  1. Myocardial infarction within 90 days of screening; OR\n  2. Coronary artery bypass procedure within 90 days of screening; OR\n  3. Current heart failure with reduced ejection fraction (\\<45%); OR\n  4. Current pulmonary arterial hypertension.\n* Known stroke within 3 months prior to planned INT1.\n* Known active bacterial, fungal, viral, or other infection besides SARS-CoV-2 requiring treatment within the 14 days prior to INT1 and meeting criteria for systemic involvement upon review by the PI.\n* Major surgery within 3 months prior to planned INT1 or planned major surgery during the first 75 days following planned INT1.\n* History of unplanned hospitalization for \\>24 hours within 28 days prior to Screening.\n* Active or prior Hepatitis B (Hep B) infection (defined as Hep B core antibody (cAb) and/or Hep B surface antigen (sAg) positive. Note: Prior hepatitis B is exclusionary even in the absence of ongoing infection.\n* Active Hepatitis C (Hep C) infection (defined as Hep C Ab positive or indeterminate with detectable Hep C RNA). Note: Those with cured Hep C (Ab positive or indeterminate but negative Hep C RNA) will remain eligible.\n* Laboratory abnormalities including:\n\n  1. ANC \\< 1,500 per mm3\n  2. Platelet count \\<100,000 per mm3\n  3. Hemoglobin \\< 9 d/dL\n  4. Baseline AST or ALT \\> 1.5 × ULN\n  5. CrCl \\< 50 (estimated glomerular filtration rate)\n* Known or suspected HIV infection.\n* End stage kidney disease requiring dialysis.\n* History of Type I or Type 2 Diabetes mellitus requiring systemic medication or insulin.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Moderate or severe immunocompromise, includes the following: (a) receiving active treatment for solid tumor or hematologic malignancy, including use of systemic chemotherapy for treatment of cancer within the year prior to screening, (b) prior solid-organ transplant with active immunosuppressive therapy, (c) CAR-T cell therapy or hematopoietic cell transplant, on immunosuppressive therapy or transplant within the prior 2 years, (d) primary immunodeficiency syndromes, advanced or untreated HIV infection (see above), (f) on active high-dose corticosteroids (ie, ≥ 20mg prednisone or equivalent daily per day for ≥ 2 weeks).\n* Known prior diagnosis of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known prior diagnosis of dysautonomia, preceding and not related to SARS-CoV-2 infection and not worsened since SARS-CoV-2 infection.\n* Known allergy to any components used in the formulation of the intervention.\n* History of anaphylaxis or similar significant allergic reaction to prescription or non-prescription drugs or food products. Similarly, the presence of severe atopic conditions as assessed by the PI represents a significant risk for allergic reaction.\n* Participation in a clinical trial with receipt of an investigational product within 28 days prior to planned INT1, except for exploratory PET imaging studies related to Long COVID.\n* Current alcohol or illicit drug use as determined by the Investigator to preclude participation.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.","locations":[{"facility":"Chan Soon-Schiong Institute for Medicine (CSSIFM)","city":"El Segundo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kayleigh Russell","phone":"424.539.2412","email":"Kayleigh.Russell@ImmunityBio.com"},{"name":"Jayson Garmizo","phone":"310.912.2230","email":"Jayson.Garmizo@ImmunityBio.com"}],"primaryOutcomes":["Incidence of treatment emergent adverse events (TEAEs) through 30 days post final study drug administration.","Incidence of grade 3 or higher TEAEs through 30 days post final study drug administration.","Incidence of serious adverse events (SAEs) through 30 days post final study drug administration.","Incidence of abnormal changes in safety laboratory tests (CBC and CMP).","Clinically important changes in vital signs such as temperature in degrees Fahrenheit.","Clinically important changes in vital signs such as heart rate in beats per minute.","Clinically important changes in vital signs such as blood pressure in millimeters of mercury (mmHg).","Clinically important changes in vital signs such as respiratory rate in breaths per minute.","Clinically important changes in vital signs such as oxygen saturation in percentage."],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["el-segundo-california"],"enrichment":{"headline":"Phase 2: testing Anktiva for Long COVID","inPlainEnglish":"This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.","whoItsFor":["Ages 18 Years to 70 Years","Age ≥ 18 and \\< 70 years","History of at least one SARS-CoV-2 infection, defined as report of a positive nucleic acid amplification test (NAAT) and/or a positive SARS-CoV-2 antigen rapid diagnostic test (RDT). Those with only suspected but unconfirmed infections are not eligible for this study","Clinical evidence of Long COVID, as confirmed by the Investigator's assessment","Symptoms must have been present for at least 60 days prior to screening. Symptoms that wax and wane must have been initially present at least 60 days prior to screening AND","Symptoms must be reported to be at least somewhat bothersome and to have an impact on quality of life and/or everyday functioning AND","At least 90 days have elapsed since the most recent suspected or confirmed SARS-CoV-2 infection and the time of screening. Note: suspected infections will be determined based upon assessment by the study Investigators","Not currently hospitalized"],"whoShouldSkip":["Previously received a SARS-CoV-2 antiviral or monoclonal antibody 30 days prior to planned INT1 or plan to receive such treatment before exiting the study","Plans to receive any investigational or approved vaccine or booster for SARS-CoV-2 within 14 days prior to plan to receive such treatment before exiting the study","History of autoimmune disease including, but not limited, to celiac disease, rheumatoid arthritis, psoriasis, and inflammatory bowel diseases","Active cardiovascular disease, defined as known prior:","Myocardial infarction within 90 days of screening; OR","Coronary artery bypass procedure within 90 days of screening; OR","Current heart failure with reduced ejection fraction (\\<45%); OR"],"whatHappens":"If you join, the listed intervention(s) are Anktiva. The registry lists allocation as na. This study will examine the safety and effectiveness of Anktiva in treating patients with Long COVID-19 which is defined as persistent symptoms of a COVID-19 infection that remain after the infection is over.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at El Segundo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.239Z"},{"nctId":"NCT07125625","title":"Probiotic Mixture (L. Rhamnosus GG and L. Plantarum 299V) In Pediatric Irritable Bowel Syndrome","officialTitle":"Randomized Double Blind Placebo Controlled Trial on a Probiotic Mixture (L. Rhamnosus GG Plus L. Plantarum 299V) in Pediatric Irritable Bowel Syndrome: Clinical Efficacy and Multiomics Approach","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of Bari","sponsorClass":"OTHER","summary":"What is this study about? This clinical study aims to investigate whether a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two). These symptoms can seriously affect a child's daily life and wellbeing.\n\nThe study is coordinated by the University of Bari, in collaboration with the University of Udine, and led by Prof. Ruggiero Francavilla.\n\nWhy is this study being done? Although probiotics are increasingly used in IBS, solid scientific evidence in children is still limited. This study will assess whether the chosen probiotic mix improves symptoms, bowel habits, and quality of life in young people with IBS. It will also investigate how the probiotics affect gut bacteria (microbiota) and the chemicals produced by the body (metabolomics), to better understand how these changes might help relieve symptoms.\n\nWho can take part? Children and adolescents aged 4 to 18 years with a diagnosis of IBS (based on international Rome IV criteria) who experience abdominal pain on a daily basis.\n\nChildren with other significant medical conditions, recent surgery, or ongoing infections, as well as those taking antibiotics or other probiotics shortly before the study, cannot participate.\n\nHow does the study work? The study is a randomised, double-blind, placebo-controlled trial, meaning that some children will receive the probiotic drops, and others will receive placebo drops (which do not contain probiotics), and neither the participants nor the doctors will know who is receiving which treatment. This is the best way to test whether the probiotics really work.\n\nEach participant will be involved in the study for about 14 weeks, divided into:\n\nA 2-week \"run-in\" period to confirm eligibility.\n\nAn 8-week treatment period (probiotic or placebo).\n\nA 4-week follow-up.\n\nThe probiotics/placebo are taken as 20 drops once daily for 8 weeks.\n\nThroughout the study, children and parents will be asked to keep a daily diary of abdominal pain and bowel habits, and to complete validated questionnaires on symptom severity and quality of life. Stool and urine samples will also be collected at different time points to analyse changes in gut bacteria and body metabolism.\n\nWhat are the aims of the study?\n\nPrimary aim:\n\nTo see whether the probiotics reduce abdominal pain by at least 30% compared to the start of the study.\n\nSecondary aims:\n\nTo check if bowel habits improve (stool consistency and frequency).\n\nTo assess improvements in quality of life.\n\nTo analyse whether the probiotics cause positive changes in gut bacteria and metabolic profiles.\n\nTo ensure that the treatment is safe and well-tolerated.\n\nWhat are the possible risks and benefits? The probiotic mixture used in this study has been studied in children before and is generally considered safe. The study includes careful monitoring for any side effects.\n\nParticipants may or may not experience an improvement in symptoms. However, the information gained from the study will help doctors better understand how probiotics work in IBS and may benefit future patients.\n\nWhat are participants' rights? Participation is voluntary, and families may withdraw their child from the study at any time, without affecting the child's medical care. The study has been approved by an independent ethics committee and complies with all European and Italian regulations regarding research in children.\n\nAll personal data and medical information will be treated confidentially and securely, in accordance with privacy laws.\n\nWhere is the study taking place? The study is being conducted at the Paediatric Gastroenterology Unit of the University of Bari Aldo Moro and the Paediatric Unit of the University of Udine. These centres are national referral centres for children with gastrointestinal problems.\n\nWho is funding and organising the study? The study is sponsored and conducted by the University of Bari. The probiotic and placebo products are provided by Dicofarm S.p.A., who also ensures that the placebo and probiotic products look and taste the same to maintain the study's blinding.","conditions":["Irritable Bowel Syndrome (IBS)"],"keywords":["food supplement","probiotics","irritable bowel syndrome"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Experimental arm: probiotic"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":124,"startDate":"2025-10-27","completionDate":"2027-06-30","sex":"ALL","minAge":"4 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children aged 4-18 years;\n* Irritable Bowel Syndrome according to Rome IV criteria\n* Average daily pain rate of at least 3 out of 10 VAS met during run-in period •-Written informed consent of parent's/legal tutor and verbal or written assent of the patient based on the minor's maturity\n\nExclusion Criteria:\n\n* Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);\n* Significant chronic health condition requiring specialty care (e.g., lithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially impact the child's ability to participate or confound the results of the study.\n* Primary or secondary immunodeficiency;\n* Malnutrition;\n* History of abdominal surgery in the past 3 months.;\n* Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;\n* Rome IV criteria diagnosis of functional constipation.\n* Use of probiotics/antibiotics within 4 weeks prior to enrolment;\n* Current pregnancy or breastfeeding;\n* Psychiatric conditions that reduce compliance with the protocol.","locations":[{"facility":"Pediatria Trambusti","city":"Bari","state":"Bari","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Of Bari Aldo Moro","city":"Bari","state":"BA","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Udine-Pediatric Section","city":"Udine","state":"UD","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ruggiero Francavilla, Prof","phone":"00390805592063","email":"rfrancavilla@gmail.com"},{"name":"fernanda Cristofori, MD","phone":"00393384176598","email":"fernandacristofori@gmail.com"}],"primaryOutcomes":["VAS visual analogue scale 0-10"],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["bari-italy","udine-italy"],"enrichment":{"headline":"Not a traditional drug phase: Experimental arm: probiotic for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"This clinical study aims to see if a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS). IBS is a common digestive condition in children, causing abdominal pain, bloating, and changes in bowel habits (either diarrhoea, constipation, or alternating between the two).","whoItsFor":["Ages 4 Years to 18 Years","Children aged 4-18 years;","Irritable Bowel Syndrome according to Rome IV criteria"],"whoShouldSkip":["Presence of other gastrointestinal diseases (inflammatory bowel disease, pancreatitis, chronic liver disease, eosinophilic esophagitis, peptic ulcer disease, celiac disease, pseudo-obstruction, small bowel bacterial overgrowth, or Hirschsprung's disease);","Primary or secondary immunodeficiency;","History of abdominal surgery in the past 3 months.;","Chronic or acute infectious diseases (viral, bacterial, parasitic) in progress;","Rome IV criteria diagnosis of functional constipation","Use of probiotics/antibiotics within 4 weeks prior to enrolment;","Current pregnancy or breastfeeding;"],"whatHappens":"If you join, the listed intervention(s) are Experimental arm: probiotic, or Placebo. The registry lists allocation as randomized. This clinical study aims to see if a specific combination of probiotics-Lactobacillus rhamnosus GG and Lactobacillus plantarum 299V-can help children and adolescents with Irritable Bowel Syndrome (IBS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 124 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.436Z"},{"nctId":"NCT07129382","title":"A Study to Evaluate the Efficacy and Safety of CS32582 in Participants With Moderate to Severe Plaque Psoriasis","officialTitle":"A Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ib/II Study to Evaluate the Efficacy and Safety of CS32582 Capsule in Adult Patients With Moderate to Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Chipscreen Biosciences, Ltd.","sponsorClass":"INDUSTRY","summary":"\" This study consists of two parts: Part 1 (Dose Escalation): A randomized, double-blind, placebo-controlled phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.\n\nPart 2 (Efficacy and Safety Assessment): A randomized, double-blind, placebo-controlled evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.\n\nThe resulting data will provide preliminary evidence on the safety and efficacy profile of CS32582, informing its subsequent development strategy.","conditions":["Plaque Psoriasis"],"keywords":[],"interventions":[{"type":"DRUG","name":"CS32582 capsule（low dose） or matched placebo"},{"type":"DRUG","name":"CS32582 capsule（high dose） or matched placebo"},{"type":"DRUG","name":"CS32582 capsule（low dose）"},{"type":"DRUG","name":"CS32582 capsule（medium dose）"},{"type":"DRUG","name":"CS32582 capsule（high dose）"}],"enrollment":220,"startDate":"2025-09-08","completionDate":"2027-09-18","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily sign the informed consent form (ICF) after fully understanding the trial.\n* Age 18-70 years (inclusive) at consent, any gender\n* Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening.\n* Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed).\n* Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;\n* Candidate for phototherapy or systemic therapy per investigator's judgment.\n* Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose.\n\nExclusion Criteria:\n\n* Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis) .\n* Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment.\n* Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs.\n* History of severe drug allergies.\n* Major surgery within 2 months before randomization or planned during the study.\n* Drug/alcohol abuse within 6 months before screening.\n* Uncontrolled hypertension at screening (SBP \\>160 mmHg or DBP \\>100 mmHg).\n* Myocardial infarction, unstable angina, TIA, stroke, PCI, or CABG within 6 months before screening.\n* NYHA Class III/IV heart failure at screening.\n* History of malignancy or lymphoproliferative disorders within 5 years (exceptions: basal cell carcinoma, localized squamous cell carcinoma, or cervical carcinoma in situ cured ≥1 year).\n* Prosthetic joint infection (unless prosthesis removed/replaced ≥2 months before randomization).\n* History of opportunistic infections (e.g., PJP, histoplasmosis, coccidioidomycosis).\n* Active/latent TB infection (positive IGRA without clinical manifestations).\n* Herpes infection:a) Active herpes zoster/simplex (HSV-1/2) at screening;b) History of severe herpes (disseminated disease, multidermatomal HSV, encephalitis, ophthalmic herpes, or recurrent zoster \\[≥2 episodes in 2 years\\]).\n* History of severe bacterial, fungal, or viral infection requiring hospitalization for IV antibiotic or antiviral administration within 2 months before randomization.\n* History of live vaccine administration within 2 months before randomization or plans to receive a live vaccine during the study period.\n* Evidence of active infection and/or febrile illness requiring systemic anti-infective therapy within 2 weeks before randomization.\n* Abnormal virology at screening:\n\n  * HBsAg(+) or HBcAb(+) with detectable HBV-DNA\n  * HCV Ab(+) with detectable HCV-RNA\n  * History of HIV infection or HIV Ab(+)\n  * Treponema pallidum Ab(+) with positive RPR/TRUST\n* Prior use of TYK2 inhibitors (e.g., deucravacitinib).\n* Use of any of the following therapeutic agents within 6 months before randomization:\n\n  * IL-12/23, IL-17, or IL-23 inhibitors (ustekinumab, secukinumab, tildrakizumab, ixekizumab, guselkumab)\n  * Rituximab or other B-cell depleting agents\n  * Leflunomide\n* Use of any of the following therapeutic agents within 3 months before randomization: Integrin pathway modulators (natalizumab) or B/T-cell modulators (alemtuzumab, abatacept, vedolizumab).\n* Use of TNF inhibitors (etanercept, adalimumab, infliximab, certolizumab) within 2 months before randomization.\n* Any biologic psoriasis therapy within 3 months or 5 half-lives (whichever longer) before randomization.\n* Use of systemic non-biologic psoriasis agents and/or any systemic immunosuppressants within 4 weeks before randomization, including but not limited to: apremilast, methotrexate, azathioprine, cyclosporine, JAK inhibitors, 6-thioguanine, mercaptopurine, mycophenolate, hydroxyurea, tacrolimus, oral/injectable corticosteroids, retinoids, calcitriol/analogs, psoralen, sulfasalazine, fumarates).\n* Use of Lithium, antimalarials, or intramuscular gold preparations within 4 weeks before randomization.\n* Use of any botanical agents for the treatment of psoriasis or other immune disorders within 4 weeks before randomization, including herbal supplements or traditional Chinese medicines derived from plants, minerals, or animals.\n* Received phototherapy within 4 weeks before randomization.\n* Use of medicated shampoos and/or body washes within 2 weeks before randomization, including but not limited to products containing: corticosteroids, coal tar, \\>3% salicylic acid, vitamin D3 analogs.\n* Use of any topical agents that may affect psoriasis symptoms within 2 weeks before randomization.\n* Received any investigational therapy within 30 days or 5 half-lives (whichever is longer) before randomization, OR current participation in other trial.\n* Laboratory values meeting any of the following criteria during screening or before randomization:\n\n  * Liver: ALT/AST ≥3×ULN; total bilirubin \\>2×ULN\n  * Hematology: WBC \\<3.0×10⁹/L (3000/mm³); ANC \\<1.0×10⁹/L (1000/mm³); lymphocyte count \\<0.5×10⁹/L (500/mm³); platelets \\<100×10⁹/L (100,000/mm³); hemoglobin \\<9.0 g/dL (90 g/L)\n  * Renal: eGFR \\<60 mL/min/1.73m² (CKD-EPI equation)\n* Pregnant or lactating women.\n* Any condition deemed unsuitable by the investigator.","locations":[{"facility":"Beijing Friendship Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Chengde Medical University","city":"Chengde","state":"Hebei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Hebei Medical University","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shiyan People's Hospital","city":"Shiyan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shandong Provincial Hospital for Skin Diseases","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"First Hospital of Shanxi Medical University","city":"Taiyuan","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xi'an Jiaotong University(Xibei Hospital )","city":"Xi’an","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","city":"Yiwu","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhengjiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jianzhong Zhang","phone":"18001315877","email":"rmzjz@126.com"}],"primaryOutcomes":["Part 1：Incidence and Severity of Adverse Events (AEs)","Part 2：Proportion of patients achieved Psoriasis Area Severity Index (PASI) 75 at Week 12"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["beijing-china","chengde-china","shijiazhuang-china","shiyan-china","jinan-china","taiyuan-china","xian-china","hangzhou-china","yiwu-china","wenzhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing CS32582 capsule（low dose） or matched placebo for Plaque Psoriasis","inPlainEnglish":"\" This study consists of two parts: Part 1 (Dose Escalation): A randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks. Part 2 (how well it works and Safety Assessment): A randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment evaluation where approximately 200 adult patients with plaque psoriasis will undergo 12 weeks of treatment.","whoItsFor":["Ages 18 Years to 70 Years","Age 18-70 years (inclusive) at consent, any gender","Clinically diagnosed with chronic plaque psoriasis, defined as disease duration ≥ 6 months at screening","Stable plaque psoriasis at screening, defined as no significant flare-ups or morphological changes during the 6 months prior to screening (investigator-assessed)","Moderate-to-severe disease at screening/randomization: PASI≥12, sPGA≥3, and BSA≥10%;","Candidate for phototherapy or systemic therapy per investigator's judgment","Women of childbearing potential and males: Agreement to use highly effective contraception from consent until 30 days post-last dose"],"whoShouldSkip":["Forms of psoriasis other than plaque-type (e.g., erythrodermic, pustular, guttate, or drug-induced psoriasis)","Presence of other skin conditions that in the judgement of the Investigator could interfere with study assessment","Immune-mediated diseases requiring systemic therapy (e.g., inflammatory bowel disease), except NSAIDs","History of severe drug allergies","Major surgery within 2 months before randomization or planned during the study","Drug/alcohol abuse within 6 months before screening","Uncontrolled hypertension at screening (SBP \\>160 mmHg or DBP \\>100 mmHg)"],"whatHappens":"If you join, the listed intervention(s) are CS32582 capsule（low dose） or matched placebo, CS32582 capsule（high dose） or matched placebo, or CS32582 capsule（low dose）. The registry lists allocation as randomized. \" This study consists of two parts: Part 1 (Dose Escalation): A randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment phase in which approximately 20 to 30 adult patients with plaque psoriasis will receive the investigational treatment for 4 weeks.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 220 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.574Z"},{"nctId":"NCT07134153","title":"Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases","officialTitle":"Evaluating Safety and Efficacy of INtrathecal or Ommaya ReserVoir Administration of T-DXd in Patients With HER2-Expressing Breast Cancer With Active Leptomeningeal and/or Brain Metastases Based on Systemic Therapy: Phase I/II Study","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fudan University","sponsorClass":"OTHER","summary":"Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Preclinical data show no detectable T-DXd/DXd in CSF, though intrathecal trastuzumab demonstrates preliminary safety/efficacy in HER2+ LM.\n\nThis study evaluates intrathecal/intra-Ommaya T-DXd plus systemic therapy in active HER2+ meningeal/brain metastases, assessing safety, intracranial efficacy, and CSF/peripheral blood T-DXd distribution to clarify BBB penetration potential. Findings may guide novel therapeutic strategies for this high-need population.","conditions":["Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"T-DXd"}],"enrollment":139,"startDate":"2025-05-12","completionDate":"2027-01-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years, regardless of gender.\n* HER2-expressing advanced or metastatic breast cancer\n* Leptomeningeal metastasis\n* Subjects with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria).\n* Adequate organ and bone marrow function\n* No radiotherapy, chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or surgery within 2 weeks prior to enrollment (or within 5 half-lives of prior therapy, whichever is shorter).\n* All prior treatment-related toxicities must have resolved to ≤Grade 1\n\nExclusion Criteria:\n\n* Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, other in situ carcinomas, or papillary thyroid carcinoma.\n* Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant cardiovascular diseases, severe chronic gastrointestinal disorders with diarrhea, or psychiatric/social conditions that may compromise compliance with study requirements, significantly increase AE risks, or impair the subject's ability to provide written informed consent.\n* History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening.\n* Clinically significant pulmonary comorbidities\n* Use of immunosuppressants or systemic corticosteroids (\\>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose (excluding intranasal/inhaled corticosteroids).\n* Any active autoimmune disease or history of autoimmune disease with potential recurrence.\n* Uncontrolled infections requiring IV antibiotics, antivirals, or antifungals.\n* Active primary immunodeficiency, known HIV infection, active HBV (HBsAg+ with HBV DNA ≥500 IU/mL) or HCV infection. HCV antibody-positive subjects are eligible only if PCR confirms HCV RNA negativity.\n* Radiographic evidence of tumor encasement/invasion of major blood vessels, or investigator-determined high risk of fatal hemorrhage due to probable vascular invasion during treatment.\n* Pregnant/lactating women, or subjects of reproductive potential unwilling/unable to use effective contraception.\n* Any other condition deemed by investigators to potentially affect trial conduct or outcome interpretation.","locations":[{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Cancer","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jian Zhang, MD, PhD","phone":"+8664175590","email":"syner2000@163.com"},{"name":"Yanchun Meng, MD","phone":"+8664175590","email":"ycmclinicaltrials@126.com"}],"primaryOutcomes":["Phase I Stage Cohort A: Maximum Tolerated Dose (MTD)","Phase I Stage Cohort B: Maximum serum concentration (Cmax)","Phase I Stage Cohort B:Time to maximum serum concentration (Tmax)","Phase I Stage Cohort B:Half-life (T1/2)","Phase II Stage Cohorts A: LM-OS","Phase II Stage Cohorts B: LM-OS","Phase II Stage Cohorts C: LM-ORR","Phase II Stage Cohorts D: LM-ORR","Phase II Stage Cohorts E: LM-OS","Phase II Stage Cohorts F: LM-OS","Phase II Stage Cohorts G: LM-ORR","Phase II Stage Cohorts H: LM-ORR"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing T-DXd for Breast Cancer","inPlainEnglish":"Multiple trials confirm systemic T-DXd how well it works in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration.","whoItsFor":["Ages 18 Years to any","Age ≥18 years, regardless of gender","HER2-expressing advanced or metastatic breast cancer","Leptomeningeal metastasis","Subjects with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria)","Adequate organ and bone marrow function","No radiotherapy, chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or surgery within 2 weeks prior to enrollment (or within 5 half-lives of prior therapy, whichever is shorter)","All prior treatment-related toxicities must have resolved to ≤Grade 1"],"whoShouldSkip":["Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, other in situ carcinomas, or papillary thyroid carcinoma","History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening","Clinically significant pulmonary comorbidities","Use of immunosuppressants or systemic corticosteroids (\\>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose (excluding intranasal/inhaled corticosteroids)","Any active autoimmune disease or history of autoimmune disease with potential recurrence","Uncontrolled infections requiring IV antibiotics, antivirals, or antifungals","Active primary immunodeficiency, known HIV infection, active HBV (HBsAg+ with HBV DNA ≥500 IU/mL) or HCV infection. HCV antibody-positive subjects are eligible only if PCR confirms HCV RNA negativity"],"whatHappens":"If you join, the listed intervention(s) are T-DXd. The registry lists allocation as randomized. Multiple trials confirm systemic T-DXd how well it works in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 139 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.348Z"},{"nctId":"NCT07135713","title":"Electrocardiographic Changes Associated With Epilepsy","officialTitle":"Electrocardiographic Changes Associated With Epilepsy in Children Attending Assiut University Children's Hospital","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Assiut University","sponsorClass":"OTHER","summary":"Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. Evaluate the duration and severity of post-ictal ECG abnormalities. Assess the correlation between ECG changes and seizure type, duration, and severity. Explore the association of ECG changes with patient demographics","conditions":["ECG Changes"],"keywords":[],"interventions":[],"enrollment":80,"startDate":"2025-10-06","completionDate":"2027-10","sex":"ALL","minAge":"1 Year","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Children from 1 year to 18 year are diagnosed with epilepsy.\n2. Routine EEG.\n\nExclusion Criteria:\n\n1. Known pre-existing cardiac conditions e.g arrhythmias, heart failure.\n2. Current use of medications significantly affecting ECG.\n3. Other causes of convulsion:hypoglycemia,hypernatriemia.","locations":[{"facility":"Assiut University Children's Hospital","city":"Asyut","state":"Asyut Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Samaan Rezk Gad El kariem, Master","phone":"0 12 21103532","email":"samaan.17289895@med.aun.edu.eg"},{"name":"Eman Fathallah Gad, Professor","phone":"0111519115 8","email":"Emnangad2019@med.aun.edu.eg"}],"primaryOutcomes":["Out come measure"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["asyut-egypt"],"enrichment":{"headline":"Electrocardiographic Changes Associated With Epilepsy","inPlainEnglish":"Identify and characterize electrocardiographic (ECG) changes occurring during the post-ictal phase of epileptic seizures. measure the duration and severity of post-ictal ECG abnormalities.","whoItsFor":["Ages 1 Year to 18 Years","Children from 1 year to 18 year are diagnosed with epilepsy"],"whoShouldSkip":["Known pre-existing cardiac conditions e.g arrhythmias, heart failure","Current use of medications significantly affecting ECG","Other causes of convulsion:hypoglycemia,hypernatriemia"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Asyut. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.910Z"},{"nctId":"NCT07135895","title":"The ArtixASCEND Study","officialTitle":"The Artix All-in-one Solution for Complete thrombEctomy With eNDovascular Approach","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Inari Medical","sponsorClass":"INDUSTRY","summary":"This study is a post-market, prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.","conditions":["Acute Lower Limb Arterial Occlusion"],"keywords":["Acute Limb Ischemia","Lower limb arterial occlusion","Artix Thrombectomy System"],"interventions":[{"type":"DEVICE","name":"Artix Thrombectomy System"}],"enrollment":250,"startDate":"2026-01-07","completionDate":"2029-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Acute symptom duration ≤ 14 days\n* Lower limb arterial occlusion below inguinal ligament\n* Target lesion in native vessel\n* Target vessel size between 3 mm and 8 mm by visual estimation\n* Rutherford category I, IIa, or IIb\n* Informed consent is obtained from either patient or legally authorized representative (LAR) per Institutional Review Board/Ethics Committee requirements\n\nExclusion Criteria:\n\n* Life expectancy \\< 6 months\n* Prior major amputation in the target limb\n* Prior minor amputation in the target limb that is not completely healed or cannot bear weight\n* Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma\n* Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure\n* Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions\n* Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated\n* Unable to tolerate antiplatelet therapy\n* Inability to anticoagulate the patient with heparin, enoxaparin or other parenteral antithrombin, or known to have uncorrected bleeding disorders (e.g., gastro-intestinal ulcer, menorrhagia, liver failure, heparin-induced thrombocytopenia (HIT))\n* Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject (e.g., contraindication to use of Artix per local approved labeling, compromise the well-being or that could prevent, limit, or confound the protocol-specified assessments)\n* Current participation in another drug or device study that, in the investigator's opinion, would interfere with participation in this study","locations":[{"facility":"California Pacific Medical Center Van Ness/Sutter Health","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Sacred Heart Pensacola","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Terrebonne General Hospital/Cardiovascular Institute of the South","city":"Houma","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MyMichigan Health","city":"Midland","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cooper University Hospital","city":"Camden","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYP-Brooklyn Methodist Hospital","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Medical Center NY","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vassar Brothers Medical Center/Nuvance Health","city":"Poughkeepsie","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stony Brook University Hospital","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Memorial Hospital","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aultman Hospital","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension St. John Jane Phillips Medical Center","city":"Bartlesville","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Francis Hospital","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny General Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Strand Medical Center","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spartanburg Regional Health System","city":"Spartanburg","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TriStar Centennial Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Houston Healthcare Medical Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellin Health","city":"Green Bay","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"James Allen","phone":"651-279-8587","email":"james.allen2@stryker.com"},{"name":"Chris Ottaviano","phone":"609-634-4571","email":"chris.ottaviano@stryker.com"}],"primaryOutcomes":["Primary Effectiveness Endpoint","Primary Safety Endpoint"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["san-francisco-california","new-haven-connecticut","washington-d-c-district-of-columbia","pensacola-florida","houma-louisiana","baltimore-maryland","boston-massachusetts","midland-michigan","camden-new-jersey","brooklyn-new-york","new-york-new-york","poughkeepsie-new-york","stony-brook-new-york","asheville-north-carolina","canton-ohio","cincinnati-ohio","bartlesville-oklahoma","tulsa-oklahoma","philadelphia-pennsylvania","pittsburgh-pennsylvania","myrtle-beach-south-carolina","spartanburg-south-carolina","nashville-tennessee","houston-texas","green-bay-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Artix Thrombectomy System for Acute Lower Limb Arterial Occlusion","inPlainEnglish":"This study is a post-market, prospective, multicenter, single-arm study to measure the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.","whoItsFor":["Ages 18 Years to any","Acute symptom duration ≤ 14 days","Lower limb arterial occlusion below inguinal ligament","Target lesion in native vessel","Target vessel size between 3 mm and 8 mm by visual estimation","Rutherford category I, IIa, or IIb"],"whoShouldSkip":["Life expectancy \\< 6 months","Prior major amputation in the target limb","Prior minor amputation in the target limb that is not completely healed or cannot bear weight","Non-thrombotic occlusion secondary to dissection, vasculitis, or target vessel trauma","Treatment of the index event in the target vessel with any other endovascular thrombectomy/aspiration or open surgical method prior to Artix procedure","Part of a vulnerable population (e.g., currently pregnant, breastfeeding or incarcerated) per local definitions","Known sensitivity to radiographic contrast agents that, in the Investigator's opinion, cannot be adequately pre-treated"],"whatHappens":"If you join, the listed intervention(s) are Artix Thrombectomy System. The registry lists allocation as na. This study is a post-market, prospective, multicenter, single-arm study to measure the safety and effectiveness of the Artix Thrombectomy System in patients with acute lower extremity arterial occlusions.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 250 people at 26 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.937Z"},{"nctId":"NCT07136116","title":"Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis","officialTitle":"A Prospective, Real-World Study Evaluating the Impact of RISankizumab on BurdEn of Disease in Ulcerative Colitis in JaPan (RISE UP)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with ulcerative colitis. Approximately 200 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 30 sites across Japan.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 156 weeks.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.","conditions":["Ulcerative Colitis"],"keywords":["Ulcerative colitis","Risankizumab","SKYRIZI"],"interventions":[],"enrollment":200,"startDate":"2025-10-09","completionDate":"2030-02","sex":"ALL","minAge":"15 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with a diagnosis of moderate to severe Ulcerative Colitis (UC) commenced on Risankizumab (RZB) treatment prescribed as part of their routine clinical care at their clinical's discretion according to Japan approved label and treatment prescription recommendations/guidelines.\n* The decision to prescribe RZB is made prior to and independently of study participation.\n* Participants able to provide voluntary informed consent before any study-related activities or procedures (obtained/documented as per regulations). If the patient is under 18 years old, a patient's parent or legal guardian must be willing to give written informed consent.\n* Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB.\n* Participants without previous exposure to RZB.\n* Participants who are not currently participating in interventional research (not including non-interventional studies, PMOS, or registry participation).\n\nExclusion Criteria:\n\nSee Inclusion Criteria","locations":[{"facility":"Aichi Medical University Hospital /ID# 278155","city":"Nagakute","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital /ID# 278159","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hirosaki University Hospital /ID# 278153","city":"Hirosaki","state":"Aomori","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chiba University Hospital /ID# 277669","city":"Chiba","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tsujinaka Hospital - Kashiwanoha /ID# 277672","city":"Kashiwa-shi","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toho University Sakura Medical Center /ID# 277536","city":"Sakura","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyushu University Hospital /ID# 278077","city":"Fukuoka","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hiroshima University Hospital /ID# 277542","city":"Hiroshima","state":"Hiroshima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo Medical University Hospital /ID# 277535","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital /ID# 277668","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo Higashi Tokushukai Hospital /ID# 278123","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe University Hospital /ID# 278292","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hyogo Medical University Hospital /ID# 277676","city":"Nishinomiya-shi","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Kyoto Prefectural University of Medicine /ID# 277541","city":"Kyoto","state":"Kyoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital /ID# 281615","city":"Okayama","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital /ID# 278619","city":"Hirakata-shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saga University Hospital /ID# 278160","city":"Saga","state":"Saga-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Medical Center /ID# 278076","city":"Kawagoe","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shiga University of Medical Science Hospital /ID# 277540","city":"Ōtsu","state":"Shiga","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamamatsu University Hospital /ID# 277539","city":"Hamamatsu","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Shizuoka Medical Center /ID# 278075","city":"Sunto-gun","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dokkyo Medical University Hospital /ID# 278152","city":"Mibu","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital /ID# 277538","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kitasato University Kitasato Institute Hospital /ID# 278154","city":"Minato-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyorin University Hospital /ID# 277534","city":"Mitaka-shi","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka University Hospital /ID# 277677","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo Kosei General Hospital /ID# 278048","city":"Sapporo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Jikei University Hospital /ID# 278122","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toyama University Hospital /ID# 277675","city":"Toyama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AbbVie GK Clinical Trial Registration Desk","phone":"+81-3-4577-1111","email":"abbvie_jpn_info_clingov@abbvie.com"}],"primaryOutcomes":["To assess the achievement of clinical remission per Partial Adapted Mayo Score of Risankizumab treatment in participants with moderate to severe Ulcerative Colitis (UC)"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["nagakute-japan","nagoya-japan","hirosaki-japan","chiba-japan","kashiwa-shi-japan","sakura-japan","fukuoka-japan","hiroshima-japan","sapporo-japan","kobe-japan","nishinomiya-shi-japan","kyoto-japan","okayama-japan","hirakata-shi-japan","saga-japan","kawagoe-japan","tsu-japan","hamamatsu-japan","sunto-gun-japan","mibu-japan","bunkyo-ku-japan","minato-ku-japan","mitaka-shi-japan","tokyo-japan","toyama-japan"],"enrichment":{"headline":"Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate…","inPlainEnglish":"Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess the change in disease activity of risankizumab treatment in adult participants with moderate to severe UC in real-world clinical practice.","whoItsFor":["Ages 15 Years to any","The decision to prescribe RZB is made prior to and independently of study participation","Participants who can understand and communicate with the investigator and comply with the requirements of the study, including collection of PRO data using a smart device (i.e., mobile phone) and continued PRO data collection after cessation of RZB","Participants without previous exposure to RZB","Participants who are not currently participating in treatment research (not including non-treatment studies, PMOS, or registry participation)"],"whoShouldSkip":["See who can join"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 29 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.580Z"},{"nctId":"NCT07137416","title":"Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer","officialTitle":"Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive tumor cells in a targeted way and delivers deruxtecan to kill them. Giving pidnarulex in combination with trastuzumab deruxtecan may be safe, tolerable and/or effective in treating patients with metastatic, unresectable, or locally advanced HER2-expressing breast cancer or other solid tumors.","conditions":["Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Invasive Breast Carcinoma","Locally Advanced Breast Carcinoma","Metastatic Breast Carcinoma","Metastatic HER2-Low Breast Carcinoma","Metastatic HER2-Positive Breast Carcinoma","Metastatic Hormone Receptor-Positive Breast Carcinoma","Metastatic Malignant Solid Neoplasm","Metastatic Triple-Negative Breast Carcinoma","Unresectable Breast Carcinoma","Unresectable HER2-Low Breast Carcinoma","Unresectable HER2-Positive Breast Carcinoma","Unresectable Hormone Receptor-Positive Breast Carcinoma","Unresectable Malignant Solid Neoplasm","Unresectable Triple-Negative Breast Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Pidnarulex"},{"type":"PROCEDURE","name":"Radiologic Imaging Procedure"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":36,"startDate":"2026-10-06","completionDate":"2028-01-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* DOSE ESCALATION PHASE ONLY: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective\n* DOSE EXPANSION PHASE ONLY: Participants must have histologically or cytologically confirmed invasive breast cancer, with either locally advanced or metastatic disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CX-5461 (pidnarulex) in combination with T-DXd in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count (ANC) ≥ 1,500/mcL\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000/mcL\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN) (or ≤ 2 × institutional ULN in patients with documented Gilbert's syndrome)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 × institutional ULN (or ≤ 5 × ULN in patients with liver metastases)\n* International normalized ratio (INR)/prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\\^2 (using the Cockcroft-Gault equation for participants with creatinine levels above institutional ULN)\n* Patients must have had at least one prior line of cytotoxic chemotherapy. Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy. Patients must not have progressed on a prior anthracycline in the metastatic setting. Receipt of anthracycline in the (neo)adjuvant setting is allowed, provided that disease recurrence occurred later than 6 months after the completion of treatment\n* Prior poly (ADP-ribose) polymerase (PARP) inhibition is allowed\n* No specific germline mutation is required\n* DOSE ESCALATION PHASE ONLY:\n\n  * HER2-positive (IHC 3+) solid cancers,\n  * HR+ HER2 positive/low/ultralow breast cancer or triple negative breast cancer (TNBC) HER2-low breast cancer, with HER2 positive defined by the current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines,\n  * HER2-low, with HER2-low defined as IHC 2+/in situ hybridization (ISH)-, IHC 1+/ISH-, or IHC 1+/ISH untested\n* DOSE EXPANSION PHASE ONLY:\n\n  * Either the primary invasive tumor and/or the metastasis must be:\n\n    * HER2-low, with HER2-low defined as IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested. Any estrogen receptor (ER) and progesterone receptor (PR) expression is permitted but must be known, or\n    * HR+ HER2-ultralow defined as IHC 0 with membrane staining\n* DOSE ESCALATION PHASE ONLY:\n\n  * Participants must have evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1\n* DOSE EXPANSION PHASE ONLY:\n\n  * Participants must have at least one lesion that is not within a previously radiated field that is measurable per RECIST v1.1. Bone lesions are not considered measurable by definition. Biopsy of the lesion that will be used for disease evaluation (measurable disease) is not allowed in the dose expansion portion of this study.\n* Peripheral neuropathy grade ≤ 1\n* Patients must have left ventricular ejection fraction (LVEF) ≥ 50% by either an echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan within 28 days before randomization/enrollment\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* The effects of CX-5461 (pidnarulex) and T-DXd on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) 14 days prior to study entry and for the duration of study participation and for at least 7 months (women of childbearing potential \\[WOCBP\\] only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Women should not breastfeed while taking CX-5461 (pidnarulex) and T-DXd and for 7 months after cessation of treatment. Men treated or enrolled on this protocol must also agree to use adequate contraception 14 days prior to the study, for the duration of study participation, and 6 months after completion of CX-5461 (pidnarulex) and T-DXd administration\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU/mL and estradiol \\< 40 pg/mL \\[\\< 147 pmol/L\\] is confirmatory) or on ovarian suppression are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male patients must not freeze or donate sperm starting at screening and throughout the study period, and at least 6 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study\n* Female patients must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic radiation therapy). These patients will be excluded because T-DXd is known to increase the risk of developing pneumonitis\n\nExclusion Criteria:\n\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, have current ILD, or where there is suspected ILD that cannot be ruled out by imaging at screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e., Rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy at the time of screening. These patients will be excluded because T-DXd is known to increase the risk of developing ILD and pneumonitis\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C. These patients will be excluded to allow for recovery of toxicities related to chemotherapy and minimize risk of drug interactions\n* Patients who have had cancer immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have had a major surgery within 4 weeks\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤ 1 or baseline. Patients with chronic grade 2 toxicities may be eligible (e.g., grade 2 chemotherapy-induced neuropathy). Patients should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy. Consult the trial overall principal investigator (PI) to determine eligibility related to chronic grade 2 toxicities\n* Eligibility of subjects receiving any medications or substances known to affect or with the potential to affect the activity of CX-5461 (pidnarulex) will be determined based on their potential to interact with the CYP3A4 isozyme. Specifically, subjects taking strong CYP3A4 inhibitors or strong CYP3A4 inducers will be excluded from participation in the trial. A list of agents that interact with CYP450 isoenzymes is provided\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to CX-5461 (pidnarulex), T-DXd, or the inactive ingredients in the drug products, including patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with clinically significant corneal disease, cicatricial conjunctivitis or active ocular surface disease in the opinion of the investigator\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant women are excluded from this study because CX-5461 (pidnarulex) and T-DXd are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with CX-5461 (pidnarulex) and T-DXd, breastfeeding should be discontinued if the mother is treated with CX-5461 (pidnarulex) and T-DXd and avoided for 7 months after the last dose","locations":[{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Maximum tolerated dose (dose escalation phase)","Incidence of adverse events with drug combination at the recommended phase 2 dose (dose expansion phase)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["boston-massachusetts","st-louis-missouri"],"enrichment":{"headline":"Phase 1: testing Pidnarulex for Anatomic Stage III Breast Cancer AJCC v8","inPlainEnglish":"This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced). Pidnarulex is an enzyme inhibitor that causes cell death and prevents tumor cell growth.","whoItsFor":["Ages 18 Years to any","DOSE ESCALATION PHASE ONLY: Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective","DOSE EXPANSION PHASE ONLY: Participants must have histologically or cytologically confirmed invasive breast cancer, with either locally advanced or metastatic disease","Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of CX-5461 (pidnarulex) in combination with T-DXd in patients \\< 18 years of age, children are excluded from this study","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)","Absolute neutrophil count (ANC) ≥ 1,500/mcL","No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment","Platelets ≥ 100,000/mcL"],"whoShouldSkip":["Patients who have had cancer immunotherapy including monoclonal antibody therapy within 4 weeks","Patients who have had a major surgery within 4 weeks","Patients who are receiving any other investigational agents","Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)","Patients with clinically significant corneal disease, cicatricial conjunctivitis or active ocular surface disease in the opinion of the investigator","Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous"],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Echocardiography Test. The registry lists allocation as na. This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein called HER2 and that has spread from where it first started (primary site) to other places in the body (metastatic), that cannot be removed by surgery (unresectable), or that has spread to nearby tissue or lymph nodes (locally advanced).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.358Z"},{"nctId":"NCT07138898","title":"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","officialTitle":"Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.","conditions":["Rheumatic Disease"],"keywords":["rheumatoid arthritis","psoriatic arthritis","ankylosing spondylitis","systemic lupus erythematosus","juvenile idiopathic arthritis","spondyloarthritis","polymyalgia rheumatica","giant cell arteritis","vasculitis","granulomatosis with polyangiitis","dermatomyositis","polymyositis","inflammatory bowel disease-associated arthritis"],"interventions":[{"type":"DRUG","name":"Methotrexate"},{"type":"DRUG","name":"Sulfasalazine"},{"type":"DRUG","name":"Hydroxychloroquine"},{"type":"DRUG","name":"Leflunomide"},{"type":"DRUG","name":"Azathioprine"},{"type":"DRUG","name":"Mycophenolate"},{"type":"DRUG","name":"Cyclosporine"},{"type":"DRUG","name":"Tacrolimus"},{"type":"DRUG","name":"Etanercept"},{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Golimumab"},{"type":"DRUG","name":"Certolizumab"},{"type":"DRUG","name":"Infliximab"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"BIOLOGICAL","name":"Belimumab"},{"type":"BIOLOGICAL","name":"Tocilizumab"},{"type":"BIOLOGICAL","name":"Anakinra"},{"type":"BIOLOGICAL","name":"Canakinumab"},{"type":"BIOLOGICAL","name":"Abatacept"},{"type":"BIOLOGICAL","name":"Secukinumab"},{"type":"BIOLOGICAL","name":"Ixekizumab"},{"type":"BIOLOGICAL","name":"Bimekizumab"},{"type":"BIOLOGICAL","name":"Ustekinumab"},{"type":"BIOLOGICAL","name":"Guselkumab"},{"type":"BIOLOGICAL","name":"Risankizumab"},{"type":"DRUG","name":"Tofacitinib"},{"type":"DRUG","name":"Upadacitinib"}],"enrollment":80,"startDate":"2025-12-12","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 18 years and older at the time of informed consent;\n2. Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis;\n3. On active immunosuppression for at least 3 months prior to scheduled surgery;\n4. Scheduled for elective total shoulder arthroplasty;\n5. Able and willing to provide written informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n* Patients with active infections or malignancies;\n* Patients undergoing shoulder arthroplasty for fracture or tumor;\n* Pregnancy or breastfeeding;\n* Unable to provide informed consent;\n* Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity;\n* Unable or without capacity to provide written informed consent prior to any study specific procedures.","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas Chalothron","phone":"646-501-7384","email":"Thomas.Chalothron@nyulangone.org"},{"name":"Vinay Bijoor","phone":"914-610-6112","email":"Vinay.Bijoor@nyulangone.org"}],"primaryOutcomes":["Incidence of wound complications","Incidence of superficial surgical site infections","Incidence of deep surgical site infections","Incidence of return trips to the operating room","Incidence of rheumatologic disease flares"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":["adalimumab","risankizumab"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Methotrexate for Rheumatic Disease","inPlainEnglish":"This study wants to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.","whoItsFor":["Ages 18 Years to any","On active immunosuppression for at least 3 months prior to scheduled surgery;","Scheduled for elective total shoulder arthroplasty;"],"whoShouldSkip":["Patients with active infections or malignancies;","Patients undergoing shoulder arthroplasty for fracture or tumor;","Pregnancy or breastfeeding;","Patients with severe SLE with marked activity - as they should be offered enrollment in the watch-and-measure (no experimental treatment required) arm. All such patients should remain on treatment to avoid worsening of disease activity;"],"whatHappens":"If you join, the listed intervention(s) are Methotrexate, Sulfasalazine, or Hydroxychloroquine. The registry lists allocation as randomized. This study wants to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at New York. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.269Z"},{"nctId":"NCT07139769","title":"Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer","officialTitle":"The RAISE Study: Adapting Psychosocial Resiliency Intervention for Parents of Adolescents and Young Adults With Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Zeba Ahmad, Ph.D.","sponsorClass":"OTHER","summary":"The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer. First, the study team will adapt an evidence-supported, group-based program for improving psychological resiliency (Stress Management and Resiliency Training - Relaxation Response Resiliency Program; SMART-3RP (E. R. Park et al., 2021)), and iteratively incorporate feedback from parents of AYAs with cancer using a mixed-methods approach. Next, the study team will pilot the refined intervention to assess for preliminary indicators of feasibility, acceptability, and potential for efficacy in reducing parental distress.","conditions":["Caregiving for Cancer"],"keywords":["adolescents and young adults with cancer","cancer caregivers"],"interventions":[{"type":"BEHAVIORAL","name":"Psychosocial Intervention for Parental Caregivers of AYA with Cancer"}],"enrollment":48,"startDate":"2025-10-22","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Self-identifying parent/guardian who provides a primary informal caregiving role in their child's cancer\n* Recipient of caregiving is aged between 15 and 39 years and is receiving treatment for cancer at the Mass General Brigham Cancer\n* Participant must score equal to or greater than 2 (out of a possible 10) on the National Comprehensive Cancer Network Distress Thermometer\n* English-speaking\n* Aged over 18 years\n\nExclusion Criteria:\n\n-Active symptoms of psychosis or suicidal ideation that would preclude safe participation","locations":[{"facility":"Mass General Brigham Cancer Institute at Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zeba N Ahmad, Ph.D.","phone":"16177241586","email":"zahmad2@mgh.harvard.edu"},{"name":"Katana Corning, B.A.","phone":"6177247593","email":"kcorning@mgh.harvard.edu"}],"primaryOutcomes":["Intervention Feasibility: Percent of Identified Prospective Participants Who Enroll","Intervention Feasibility: Proportion of Participants Completing the Program","Intervention Acceptability"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Psychosocial Intervention for Parental Caregivers of AYA with Cancer for Caregiving for Cancer","inPlainEnglish":"The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer. First, the study team will adapt an evidence-supported, group-based program for improving psychological resiliency (Stress Management and Resiliency Training - Relaxation Response Resiliency Program; SMART-3RP (E.","whoItsFor":["Ages 18 Years to any","Self-identifying parent/guardian who provides a primary informal caregiving role in their child's cancer","Recipient of caregiving is aged between 15 and 39 years and is receiving treatment for cancer at the Mass General Brigham Cancer","Participant must score equal to or greater than 2 (out of a possible 10) on the National Comprehensive Cancer Network Distress Thermometer"],"whoShouldSkip":["Active symptoms of psychosis or suicidal ideation that would preclude safe participation"],"whatHappens":"If you join, the listed intervention(s) are Psychosocial Intervention for Parental Caregivers of AYA with Cancer. The registry lists allocation as na. The study team aims to adapt a psychosocial intervention to reduce psychological distress among the caregiving parents of adolescents and young adults (aged 15-39) who have cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 48 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.434Z"},{"nctId":"NCT07140094","title":"Long-Covid-19 Alleviation Through Learning Mindfulness Study","officialTitle":"Long-Covid-19 Alleviation Through Learning Mindfulness Study (LONG-CALM)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Columbia University","sponsorClass":"OTHER","summary":"This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Mindfulness is defined as paying attention to the present moment with non-judgment and acceptance. Here the investigators are studying whether a mindfulness intervention can help reduce stress, reduce Long COVID symptoms, and improve quality of life among people living with Long COVID. The mindfulness intervention is a series of recorded mindfulness sessions, which were created by the study team. People who decide to take part will be randomly assigned to receive the study mindfulness intervention immediately after joining the study or to receive the study mindfulness intervention 8 weeks after joining the study. All participants will continue their usual medical care. Participants will complete online surveys to measure symptoms over time. The study will last 6 months.","conditions":["Long COVID","Long Covid19","Post-Acute COVID-19","Post-Acute COVID-19 Syndrome","Post-Acute COVID-19 Infection","COVID Long-Haul"],"keywords":["Covid"],"interventions":[{"type":"BEHAVIORAL","name":"Structured mindfulness intervention"}],"enrollment":400,"startDate":"2024-05-21","completionDate":"2027-05-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> or = 18\n* Willing and able to provide informed consent\n* Access to the internet\n* Self-reported history of SARS-CoV-2 infection\n* Current symptoms attributed to PASC by participant or by participant's medical provider; ongoing symptoms that persisted \\>= 12 weeks after Covid-19 illness\n\nExclusion Criteria:\n\n* Participating in another clinical trial of an intervention for PASC symptoms\n* Engaged in a structured MBI","locations":[{"facility":"Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deborah Theodore, MD","phone":"2123058739","email":"dat2132@cumc.columbia.edu"}],"primaryOutcomes":["Mean Score of Patient-Reported Outcomes Measurement Information System (PROMIS) Global 10 Score"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Structured mindfulness intervention for Long COVID","inPlainEnglish":"This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID. Mindfulness is defined as paying attention to the present moment with non-judgment and acceptance.","whoItsFor":["Ages 18 Years to any","Access to the internet","Self-reported history of SARS-CoV-2 infection","Current symptoms attributed to PASC by participant or by participant's medical provider; ongoing symptoms that persisted \\>= 12 weeks after Covid-19 illness"],"whoShouldSkip":["Participating in another clinical trial of an intervention for PASC symptoms","Engaged in a structured MBI"],"whatHappens":"If you join, the listed intervention(s) are Structured mindfulness intervention. The registry lists allocation as randomized. This research is being done to study a mindfulness intervention among people who have symptoms of Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as Long COVID.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.243Z"},{"nctId":"NCT07140484","title":"Sotatercept in Pulmonary Arterial Hypertension","officialTitle":"A Single-arm, Open-label Phase IV Study to Evaluate the Effectiveness of Sotatercept in Improving Pulmonary Vascular Recruitment in Patients With Pulmonary Arterial Hypertension (PAH)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Alberta","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.\n\nParticipants will be asked to:\n\n* Take Sotatercept every 21 days (±3 days)\n* Each participant will be enrolled in the study for 29 Weeks\n* Visit the clinic 18 times\n* Have a physical exam\n* Perform assessments of lung function and exercise tests\n* Have an ultrasound of their heart\n* Have blood draws done at regular intervals\n\nThe main objectives of the study are:\n\nPrimary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.\n\nSecondary objective: To identify components of the diffusing capacity that respond to treatment with sotatercept in pulmonary arterial hypertension.","conditions":["Pulmonary Artery Hypertension"],"keywords":["diffusing capacity","membrane diffusing capacity","pulmonary capillary blood volume"],"interventions":[{"type":"DRUG","name":"Sotatercept"}],"enrollment":27,"startDate":"2025-10-06","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Eligible participants must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Age ≥ 18 years.\n2. Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:\n\n   * Idiopathic PAH\n   * Heritable PAH\n   * Drug/toxin-induced PAH\n   * PAH associated with CTD\n   * PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair.\n3. Symptomatic PAH classified as WHO FC II or III.\n4. On stable doses of ≥2 background PAH therapies for at least 60 days prior to screening; for infusion prostacyclins, dose adjustment within 10% of the optimal dose is allowed per medical practice. Patients on 1 background PAH therapy are eligible if there is documented intolerance or contraindication to use of the other 2 classes (e.g. liver enzyme elevation while taking an ERA).\n5. Females of childbearing potential must:\n\n   * Have a negative urine or serum pregnancy tests as verified by the investigator prior to starting study therapy.\n   * If sexually active, have used, and agree to use highly effective contraception without interruption during the study (including dose interruptions), and for 16 weeks (112 days) after discontinuation of study treatment.\n   * Refrain from breastfeeding a child or donating blood, eggs, or ovum for the duration of the study and for at least 16 weeks (112 days) after the last dose of study treatment.\n6. Male participants must:\n\n   * Agree to use a condom, defined as a male latex condom or nonlatex condom NOT made out of natural (animal) membrane (e.g., polyurethane), during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 16 weeks (112 days) following investigational product discontinuation, even if he has undergone a successful vasectomy.\n   * Refrain from donating blood or sperm for the duration of the study and for 16 weeks (112 days) after the last dose of study treatment\n7. Ability to adhere to study visit schedule and understand and comply with all protocol requirements.\n8. Ability to understand and provide written informed consent.\n\nExclusion Criteria\n\n1. 1\\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5\n2. Musculoskeletal limitation that precludes participation in cycle ergometry\n3. Resting oxygen saturation \\< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen).\n4. Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease.\n5. Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test.\n6. Baseline platelet count \\< 50,000/mm3 (\\< 50.0 × 109/L) in the enrollment period.\n7. Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\> 160 mmHg or sitting diastolic blood pressure \\> 100 mmHg during a screening visit after a period of rest.\n8. Baseline systolic blood pressure \\< 90 mmHg at screening.\n9. Pregnant or breastfeeding women.\n10. Any of the following clinical laboratory values at the screening visit:\n\n    * Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/m2 (as defined by the Modification of Diet in Renal Disease \\[MDRD\\] equation)\n    * Serum alanine aminotransferase, aspartate aminotransferase, or total bilirubin levels \\> 3 × ULN (bilirubin criterion waived if there is a documented history of Gilbert's syndrome).\n11. Currently enrolled in or have completed any other investigational product study within 30 days for small-molecule drugs or within 5 half-lives for biologics prior to the date of signed informed consent.\n12. History of full pneumonectomy.\n13. Pulmonary function test (PFT) values of forced vital capacity (FVC) \\< 60% predicted and/or FEV1/FVC \\< lower limit of normal at the screening visit or within 6 months prior to the screening visit.\n14. Smoking history of ≥ 20 pack-years or any tobacco smoking or vaping within the previous 3 months.\n15. Body mass index ≥ 40 kg/m2.\n16. Planned initiation of an exercise program for cardiopulmonary rehabilitation during the study (participants who are stable in the maintenance phase of a program and who will continue for the duration of the study are eligible).\n17. Known history of portal hypertension or chronic liver disease, including hepatitis B and/or hepatitis C (with evidence of recent infection and/or active virus replication), defined as mild to severe hepatic impairment (Child-Pugh Class A-C).\n18. History of restrictive, constrictive, or congestive cardiomyopathy.\n19. History of atrial septostomy within 180 days prior to the screening visit.\n20. Electrocardiogram (ECG) with Fridericia's corrected QT interval (QTcF) \\> 500 ms during the Screening Period\n21. Personal or family history of long QT syndrome (LQTS) or sudden cardiac death.\n22. Left ventricular ejection fraction \\< 45% on historical echocardiogram within 6 months prior to the screening visit.\n23. Any symptomatic coronary disease events (prior myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft surgery, or cardiac anginal chest pain) within 6 months prior to the screening visit. Note: Anginal pain can be ignored as an exclusion criterion if coronary angiography shows no obstructions.\n24. Cerebrovascular accident within 3 months prior to the Screening Visit.\n25. Significant mitral or aortic valve dysfunction (greater than moderate mitral regurgitation or aortic regurgitation, or greater than mild mitral stenosis or aortic stenosis).\n26. Received intravenous inotropes (e.g., dobutamine, dopamine, norepinephrine, vasopressin) within 30 days prior to the screening visit.\n27. Known hypersensitivity to sotatercept or to any ingredient in the formulation or component of the container.","locations":[{"facility":"Clinical Physiology Laboratory","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Desi Fuhr, MSc","phone":"7804921121","email":"fuhr@ualberta.ca"},{"name":"Kostia Dmytriiev, MD","phone":"7804928027","email":"kdmytrii@ualberta.ca"}],"primaryOutcomes":["Lung diffusing capacity","Lung diffusing capacity","Diffusing membrane capacity (Dm)","Diffusing membrane capacity (Dm)","Pulmonary capillary blood volume (Vc)","Pulmonary capillary blood volume (Vc)"],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["edmonton-canada"],"enrichment":{"headline":"Phase 4: testing Sotatercept for Pulmonary Artery Hypertension","inPlainEnglish":"The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension. you would be asked to: * Take Sotatercept every 21 days (±3 days) * Each you would be enrolled in the study for 29 Weeks * Visit the clinic 18 times * Have a physical exam * Perform assessments of lung function and exercise tests * Have an ultrasound of their heart * Have blood draws done at regular intervals The main objectives of the study are: Primary objective: To assess whether sotatercept will improve recruitment of diffusing membrane capacity (DM) with exercise.","whoItsFor":["Ages 18 Years to any","Eligible participants must meet all of the following to be enrolled in the study:","Documented diagnostic right heart catheterization (RHC) at any time prior to screening confirming the diagnosis of PAH Group 1 in any of the following subtypes:","Drug/toxin-induced PAH","PAH associated with CTD","PAH associated with simple, congenital systemic-to-pulmonary shunts at least 1 year following repair","Symptomatic PAH classified as WHO FC II or III","Females of childbearing potential must:"],"whoShouldSkip":["1\\. Diagnosis of pulmonary hypertension WHO Groups 2, 3, 4, or 5","Musculoskeletal limitation that precludes participation in cycle ergometry","Resting oxygen saturation \\< 88%. (Note: patients on oxygen can be included in the study if they can maintain a resting saturation of ≥ 88 % after 3 minutes off oxygen)","Diagnosis of the following PAH Group 1 subtypes: human immunodeficiency virus (HIV)-associated PAH and PAH associated with portal hypertension, schistosomiasis-associated PAH and pulmonary veno-occlusive disease","Hemoglobin (Hgb) at screening above the gender-specific upper limit of normal (ULN), per local laboratory test","Baseline platelet count \\< 50,000/mm3 (\\< 50.0 × 109/L) in the enrollment period","Uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure \\> 160 mmHg or sitting diastolic blood pressure \\> 100 mmHg during a screening visit after a period of rest"],"whatHappens":"If you join, the listed intervention(s) are Sotatercept. The registry lists allocation as na. The goal of this clinical trial is to determine whether sotatercept is effective in improving diffusing capacity in patients with pulmonary arterial hypertension.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 27 people at Edmonton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.043Z"},{"nctId":"NCT07140913","title":"A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.","conditions":["Mania","Bipolar Disorder"],"keywords":["Bipolar-I Disorder","Mania","KarXT","adjunctive treatment","mood stabilizer"],"interventions":[{"type":"DRUG","name":"Xanomeline/Trospium Chloride"},{"type":"DRUG","name":"Placebo"}],"enrollment":424,"startDate":"2025-10-08","completionDate":"2027-06-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.\n* Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).\n* The individual requires hospitalization for the acute exacerbation or relapse of mania.\n* Body mass index ≥ 18 and ≤ 40 kg/m2.\n* Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.\n* YMRS Total Score of ≥ 18 at Screening and at Baseline, and \\< 20% reduction in YMRS from screening to baseline.\n\nExclusion Criteria:\n\n* Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.\n* Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.\n* Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer \"Yes\" to item 4 or 5 within 6 months before screening or between screening and baseline, or \"Yes\" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.\n* History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.\n* History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.\n* Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.\n* Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin \\> 1.5× ULN, unless in the context of Gilbert's syndrome.\n* All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\]).\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Pillar Clinical Research - Bentonville","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research- Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group.","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proscience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omega Clinical Trials - La Habra","city":"La Habra","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NRC Research Institute","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Synergy Clinical Research","city":"Boynton Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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O.I. Yushchenko of VRC\"","city":"Vinnytsia","state":"Vinnytsia Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Non-Commercial Enterprise \"Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council","city":"Kropyvnytskyi","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNCE \"Clinical Facility for Mental Health Care \"PSYCHIATRY\" of executive body of Kyiv City Council (KCSA)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Enterprise \"Regional Institution of Mental Psychiatric Care of the Poltava Regional Council\"","city":"Poltava","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal non-commercial enterprise \"Cherkasy regional psychiatric hospital of Cherkasy regional council\"","city":"Smila","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0206","city":"Ternopil","state":"","country":"Ukraine","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Change from baseline in Young Mania Rating Scale (YMRS) at Week 5"],"hasResults":false,"conditionSlugs":["bipolar-disorder"],"drugSlugs":[],"locationSlugs":["bentonville-arkansas","little-rock-arkansas","bellflower-california","chino-california","culver-city-california","la-habra-california","montclair-california","orange-california","riverside-california","boynton-beach-florida","hallandale-florida","miami-florida","savannah-georgia","chicago-illinois","indianapolis-indiana","st-louis-missouri","staten-island-new-york","austin-texas","desoto-texas","houston-texas","mansfield-texas","richardson-texas","abb-argentina","c-rdoba-argentina","mendoza-argentina","santiago-del-estero-argentina","kazanlak-bulgaria","novi-iskar-bulgaria","pleven-bulgaria","sliven-bulgaria","targovishte-bulgaria","beijing-china","guangzhou-china","baoding-china","shijiazhuang-china","changsha-china","nanjing-china","xian-china","chengdu-china","tianjin-china","ningbo-china","hiller-d-denmark","aalborg-denmark","glostrup-municipality-denmark","nice-france","clermont-ferrand-france","marseille-france","montpellier-france","paris-france","mangaluru-india","madurai-india","kolkata-india","mangalore-india","hod-hasharon-israel","ramat-gan-israel","ashkelon-israel","beersheba-israel","jerusalem-israel","milan-italy","pisa-italy","siena-italy","ancona-italy","genova-italy","toyoake-japan","ichikawa-japan","iizuka-japan","kitakyushu-shi-japan","sapporo-japan","yokohama-japan","karatsu-japan","bunkyo-ku-japan","kodaira-japan","tabashi-city-japan","fukuoka-japan","kochi-japan","wakayama-japan","warsaw-poland","bialystok-poland","gdansk-poland","rybnik-poland","tuszyn-poland","bucharest-romania","ia-i-romania","sanpetru-brasov-romania","sibiu-romania","dnipro-ukraine","skarzhyntsi-ukraine","hlevakha-ukraine","lviv-ukraine","odesa-ukraine","oleksandrivka-ukraine","vinnytsia-ukraine","kropyvnytskyi-ukraine","kyiv-ukraine","poltava-ukraine","smila-ukraine","ternopil-ukraine"],"enrichment":{"headline":"Phase 3: testing Xanomeline/Trospium Chloride for Mania","inPlainEnglish":"This study wants to measure the how well it works and safety of added on top of your current treatment KarXT for the treatment of mania in participants with Bipolar-I Disorder.","whoItsFor":["Ages 18 Years to 65 Years","Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2","Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks)","The individual requires hospitalization for the acute exacerbation or relapse of mania","Body mass index ≥ 18 and ≤ 40 kg/m2","YMRS Total Score of ≥ 18 at Screening and at Baseline, and \\< 20% reduction in YMRS from screening to baseline"],"whoShouldSkip":["Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test","History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months","History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma","Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results","Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin \\> 1.5× ULN, unless in the context of Gilbert's syndrome","All grades of hepatic impairment (mild \\[Child-Pugh Class A\\], moderate \\[Child-Pugh Class B\\], and severe \\[Child-Pugh Class C\\])","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Xanomeline/Trospium Chloride, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of added on top of your current treatment KarXT for the treatment of mania in participants with Bipolar-I Disorder.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 424 people at 106 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.730Z"},{"nctId":"NCT07141355","title":"Empagliflozin's Microcirculatory Effects in Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial","officialTitle":"Microcirculatory Effects of Empagliflozin in Patients With Cardiogenic Shock: an Ancillary Pilot Study of the EMPASHOCK Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Hospital, Strasbourg, France","sponsorClass":"OTHER","summary":"Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%. The EMPULSE-HF trial showed that early introduction of empagliflozin in stabilized patients with acute heart failure led to a composite benefit in mortality, rehospitalization, and quality of life.\n\nGrowing evidence suggests that cardiogenic shock isn't just a problem of systemic macrocirculation (blood pressure, cardiac output). It also involves significant abnormalities in the systemic microcirculation. In fact, these microcirculatory parameters have proven to be better predictors of patient outcomes than traditional macrocirculatory measures.\n\nGiven its known vasculo-protective effects on the endothelium, empagliflozin may have a beneficial impact on the microcirculation, potentially explaining its positive effects in cardiogenic shock.\n\nThis study will explore this hypothesis by analyzing the microcirculation in real-time using the CytoCam-IDF imaging videomicroscope and its MicroTools software. The goal is to gain a deeper understanding of how empagliflozin affects the microcirculation during cardiogenic shock.","conditions":["Cardiogenic Shock"],"keywords":["Cardiogenic Shock","Acute Heart failure","Heart failure"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"microcirculation using the video microscopy tool."}],"enrollment":24,"startDate":"2025-12-12","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient included in the main EMPASHOCK study\n* Patient has signed a consent form for the ancillary study\n* Patient is over 18 years old\n* Hospitalized in the Intensive Care Unit for cardiogenic shock\\*\n* Has been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock\\*\\*\n* Patient has the ability to take tablets orally\n* Person is affiliated with or a beneficiary of a social security system\n\nExclusion Criteria:\n\n* • GFR \\< 20 ml/min/1.73m²\n\n  * Chronic dialysis\n  * Patient on SGLT2 inhibitors prior to ICU admission\n  * Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome).\n  * Patient on lithium\n  * Patient with type 1 diabetes\n  * Patient in shock due to another cause or moribund patient (IGS 2 \\> 90)\n  * Cardiogenic shock cases excluded in the EMPASHOCK study: a. Heart transplant recipient or on a transplant list. b. Peripartum, adrenergic, valvular, restrictive, or post-embolic cardiomyopathy. c. Related to cardiotropic drug intoxication. d. Secondary to cardiac arrest where the patient remains comatose before inclusion.\n  * Woman of childbearing age without effective contraception\n  * Person referred to in Articles 10, 31, 32, 33, and 34 of EU Regulation 536/2014, specifically:\n* Pregnant woman, woman in labor, or breastfeeding mother\n* Minor person (not emancipated)\n* Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)","locations":[{"facility":"Hôpitaux Universitaires de Strasbourg","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The difference in the evolution of a parameter reflecting the microcirculation between the two groups at 48 hours post-randomization."],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":["empagliflozin"],"locationSlugs":["strasbourg-france"],"enrichment":{"headline":"Not a traditional drug phase: microcirculation using the video microscopy tool. for Cardiogenic Shock","inPlainEnglish":"Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%. The EMPULSE-HF trial showed that early introduction of empagliflozin in stabilized patients with acute heart failure led to a composite benefit in mortality, rehospitalization, and quality of life.","whoItsFor":["Ages 18 Years to any","Patient included in the main EMPASHOCK study","Patient has signed a consent form for the ancillary study","Patient is over 18 years old","Hospitalized in the Intensive Care Unit for cardiogenic shock\\*","Has been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock\\*\\*","Patient has the ability to take tablets orally","Person is affiliated with or a beneficiary of a social security system"],"whoShouldSkip":["GFR \\< 20 ml/min/1.73m²","Patient on SGLT2 inhibitors prior to ICU admission","Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome)","Patient with type 1 diabetes","Patient in shock due to another cause or moribund patient (IGS 2 \\> 90)","Woman of childbearing age without effective contraception","Person referred to in Articles 10, 31, 32, 33, and 34 of EU Regulation 536/2014, specifically:"],"whatHappens":"If you join, the listed intervention(s) are microcirculation using the video microscopy tool.. The registry lists allocation as randomized. Despite advancements in treatment, the mortality rate for cardiogenic shock (CS) remains high at around 50%.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24 people at Strasbourg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.621Z"},{"nctId":"NCT07142356","title":"A Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension","officialTitle":"A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study of Modified Release RTN-001 In Patients With Uncontrolled Hypertension","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Retension Pharmaceuticals. Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical trial is to measure the safety and efficacy of RTN-001 in adult participants with uncontrolled hypertension versus placebo.","conditions":["Uncontrolled Hypertension"],"keywords":["hypertension","uncontrolled hypertension","RTN-001","blood pressure","systolic","diastolic"],"interventions":[{"type":"DRUG","name":"RTN-001"},{"type":"DRUG","name":"Matching placebo control"}],"enrollment":280,"startDate":"2025-10-31","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female patients age 18 to 75 years, inclusive, at the Screening Visit.\n* Uncontrolled HTN despite being on a stable regimen of 2-5 antihypertensive medications.\n* Mean BP of ≥135/80 mm Hg.\n* Body mass index of 18 to 35 kg/m2.\n\nExclusion Criteria:\n\n* Mean seated SBP \\>175 mm Hg and/or DBP \\>110 mm Hg.\n* Current or planned use of nitrates and/or alpha-blockers or other drugs known to affect BP during the study period.\n* Participants who use PDE5 inhibitors for other indications that cannot or will not refrain from use of PDE5 inhibitors for 7 days before and during their entire period of participation in the study.\n* History of hypotension, fainting spells, blackouts or autonomic dysfunction, including orthostatic hypotension.\n* Known diagnosis of secondary hypertension (e.g. Cushing's Disease or hyperaldosteronism, renal fibrodysplasia, renal artery stenosis, etc., clinically significant aortic stenosis etc.).\n* Recent (within 3 months before the Screening Visit \\[Visit S1\\]) myocardial infarction; unstable angina leading to hospitalization; uncontrolled, symptomatic atrial fibrillation, or any cardiac arrhythmia that has not been clinically stable for at least 3 months prior to screening. Participants with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the Investigator to be stable for the previous 3 months.\n* Uncontrolled hypothyroidism\n* Liver disease or dysfunction\n* Renal dysfunction (\\<45 mL/min/1.73m²) or glomerulonephritis\n* Active infection or major illness\n* Gastrointestinal conditions or procedures (including weight loss surgery \\[eg, Lap-Band or gastric bypass\\]) that may affect drug absorption.\n* Hematologic or coagulation disorders\n* Active malignancy\n* Unexplained creatine kinase (CK) \\>3 × ULN at any time before randomization\n* A known history of temporary or permanent partial or total vision loss\n* A known history of \"crowded\" optic disc.\n* A known history of retinitis pigmentosa, a rare genetic eye disease.\n* Any prescription or over-the counter drugs or herbal supplements known to be strong inhibitors of CYP3A4 enzymes\n* NHYA class III-IV symptoms of heart failure.\n* History of diabetes or suspected diabetes with glycosylated hemoglobin \\> 10% or fasting glucose \\>250 mg/dl at Screening Visit (S1).","locations":[{"facility":"Retension Clinical Site","city":"Alexander City","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"San Jose","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Ventura","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Leesburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Port Orange","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Peachtree Corners","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clincial Site","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Methuen","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Bloomfield Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Overland","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Asheboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRO Call Center","city":"Tulsa","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clincal Site","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retension Clinical Site","city":"Vienna","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Information","phone":"7036242024","email":"clinicalinformation@retensionpharmaceuticals.com"}],"primaryOutcomes":["Mean change in systolic blood pressure (SBP) at 4 weeks"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["alexander-city-alabama","birmingham-alabama","glendale-arizona","tucson-arizona","pasadena-california","san-diego-california","san-jose-california","ventura-california","west-hills-california","waterbury-connecticut","boca-raton-florida","jacksonville-florida","leesburg-florida","maitland-florida","orlando-florida","port-orange-florida","tampa-florida","decatur-georgia","lawrenceville-georgia","peachtree-corners-georgia","indianapolis-indiana","munster-indiana","new-orleans-louisiana","boston-massachusetts","methuen-massachusetts","bloomfield-hills-michigan","overland-missouri","las-vegas-nevada","the-bronx-new-york","asheboro-north-carolina","charlotte-north-carolina","monroe-north-carolina","cincinnati-ohio","tulsa-oklahoma","charleston-south-carolina","north-charleston-south-carolina","bellaire-texas","dallas-texas","plano-texas","san-antonio-texas","sugar-land-texas","vienna-virginia"],"enrichment":{"headline":"Phase 2: testing RTN-001 for Uncontrolled Hypertension","inPlainEnglish":"The purpose of this clinical trial is to measure the safety and how well it works of RTN-001 in adult participants with uncontrolled hypertension versus dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 75 Years","Male or female patients age 18 to 75 years, inclusive, at the Screening Visit","Uncontrolled HTN despite being on a stable regimen of 2-5 antihypertensive medications","Mean BP of ≥135/80 mm Hg","Body mass index of 18 to 35 kg/m2"],"whoShouldSkip":["Mean seated SBP \\>175 mm Hg and/or DBP \\>110 mm Hg","Current or planned use of nitrates and/or alpha-blockers or other drugs known to affect BP during the study period","Participants who use PDE5 inhibitors for other indications that cannot or will not refrain from use of PDE5 inhibitors for 7 days before and during their entire period of participation in the study","History of hypotension, fainting spells, blackouts or autonomic dysfunction, including orthostatic hypotension","Known diagnosis of secondary hypertension (e.g. Cushing's Disease or hyperaldosteronism, renal fibrodysplasia, renal artery stenosis, etc., clinically significant aortic stenosis etc.)","Uncontrolled hypothyroidism","Liver disease or dysfunction"],"whatHappens":"If you join, the listed intervention(s) are RTN-001, or Matching placebo control. The registry lists allocation as randomized. The purpose of this clinical trial is to measure the safety and how well it works of RTN-001 in adult participants with uncontrolled hypertension versus dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 280 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.045Z"},{"nctId":"NCT07144137","title":"A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)","officialTitle":"A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Complement Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a non-interventional, observational study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years.\n\nThis is a multi-center, non-interventional, observational study which aims to identify participants who have progressive GA to allow quantification of structural and functional parameters that characterize the progression of GA, and to investigate whether these correlate with genetic or lifestyle factors.","conditions":["Geographic Atrophy Secondary to Age-related Macular Degeneration"],"keywords":["GA","AMD","Geographic atrophy","Dry AMD","Age-related macular degeneration"],"interventions":[],"enrollment":75,"startDate":"2025-07-30","completionDate":"2027-03-31","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion:\n\n1. Participants must be aged ≥55 years, at the time of signing the informed consent at the screening visit.\n2. Participants with bilateral GA secondary to AMD as confirmed by the Central Reading Center using FAF and/or OCT images with at least 1 eye having a total GA lesion area must be between 1.25 mm2 and 17.5 mm2 inclusive, determined by FAF images taken at the screening visit.\n3. Best-corrected visual acuity (BCVA) in both eyes should be sufficient to ensure navigational vision (defined as 20/400 or better for purposes of this study).\n4. BCVA between 20 and 75 letters and LLVA\\>0 letters using an ETDRS chart.\n5. Mean retinal sensitivity as measured by microperimetry using the study grid must be equal to or greater than 5 dB.\n6. Able and willing to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, and in the opinion of the investigator, is able to perform all study assessments.\n\nExclusion criteria:\n\n1. Macular atrophy secondary to any condition other than AMD in the study eye.\n2. Any pathology of the macula other than GA secondary to AMD and other changes consistent with early, intermediate or atrophic AMD in the study eye.\n3. Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye.\n4. Atrophic retinal disease of causality other than AMD including monogenetic macular dystrophies (incorporating pattern dystrophy), myopia-related maculopathy and Stargardt disease in the study eye.\n5. A history of vitrectomy in the study eye.\n6. Any prior treatment for AMD or any prior intravitreal treatment for any indication in the study eye, except oral supplements of vitamins and minerals such as the age-related eye disease study (AREDS) formula.\n7. Any intraocular surgery (except cataract surgery within 6 months of enrollment) or thermal laser within 3 months of screening, or any ophthalmic condition that may require surgery during the study.\n8. Any macular laser, macular surgery or retinal surgery at any time point in the study eye.\n9. Any ocular or periocular infection in the 12 weeks prior to screening.\n10. History of uveitis or endophthalmitis in either eye.\n11. Any sign of diabetic retinopathy in either eye, or HbA1c \\>8, in the 12 months prior to enrollment.\n12. High myopia or hyperopia (≥6 diopter) in the study eye.\n13. Uncontrolled IOP measurement of ≥25 mmHg for \\>1 month despite being on 2 or more ocular hypotensive agents, or IOP \\>21 mm Hg in the presence of C/D asymmetry of \\>0.3 per the reading center; or glaucomatous damage to the optic nerve or visual field.\n14. Retinal disease other than AMD or other ocular disorders which may cause safety concerns per the judgment of the investigator; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).\n15. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination (e.g., cataract or corneal abnormalities) either at the time of enrollment or during the 2-year post dosing follow-up period; or prevents adequate imaging of the retina judged by the site or CRC.\n16. Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to baseline.\n17. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections, including but not limited to immunodeficiency state, autoimmune diseases, malignancy other than prostate or basal cell carcinoma, connective tissue disorders and collagen vascular disorders.\n18. Participation in an interventional clinical study, or use of any experimental treatment for AMD or any investigational product within 6 months or 5 half-lives of the active ingredient (whichever is longer) prior to screening.\n19. History of abnormal laboratory tests (e.g. hematology, serum chemistry, renal or liver function tests, or infectious disease screen) that in the opinion of the investigator is clinically significant at the time of enrollment and not suitable for study participation.\n20. Hypersensitivity to medications used in (standard of care) study procedures.\n21. Situations where, in the opinion of the investigator, the risk of harm to a participant outweighs any potential benefits from study participation (these could include participants with conditions such as brittle diabetes or advanced osteoporosis as examples).\n22. History or current use of medications associated with macular changes, retinal dysfunction or optic nerve damage. These include but are not limited to the following prohibited concomitant medications:\n23. Any previous gene or cell therapy (ophthalmic or systemic),\n24. Chloroquine (where taken for \\>30 days cumulative across participant's lifetime), hydroxychloroquine, platinum containing medications, ethambutol, tamoxifen, pentosan, chronic use of phosphodiesterase inhibitors, and GLP-1 antagonists in the setting of a crowded optic disc.","locations":[{"facility":"Northern California Retina Vitreous Associates Medical Group","city":"Mountain View","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University Retina and Macula Associates","city":"Oak Forest","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Eye Institute","city":"Carmel","state":"Indiana","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Sierra Eye Associates","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Eye Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Carolina Retina Associates","city":"Wake Forest","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Atlantic Retina","city":"Bethlehem","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Foundation of the Southwest","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gundersen Health System","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gloucestershire Royal Hospital","city":"Gloucester","state":"Gloucester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moorfields Eye Hospital","city":"London","state":"London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Middlesex Hospital","city":"London","state":"London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Southampton","city":"Southampton","state":"Southampton","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunderland Eye lnfirmary","city":"Sunderland","state":"Sunderland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Belfast City Hospital","city":"Belfast","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frimley Park Hospital","city":"Frimley","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Retina Clinic London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manchester Royal Eye Hospital","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Muhammad Ali Memon","phone":"","email":"clinicaloperations@complementtx.com"}],"primaryOutcomes":["Short-term GA Progression"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["mountain-view-california","oak-forest-illinois","springfield-illinois","carmel-indiana","reno-nevada","durham-north-carolina","wake-forest-north-carolina","bethlehem-pennsylvania","dallas-texas","la-crosse-wisconsin","gloucester-united-kingdom","london-united-kingdom","southampton-united-kingdom","sunderland-united-kingdom","belfast-united-kingdom","frimley-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)","inPlainEnglish":"This is a non-treatment, watch-and-measure (no experimental treatment required) study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years. This is a multi-center, non-treatment, watch-and-measure (no experimental treatment required) study which aims to identify participants who have progressive GA to allow quantification of structural and functional parameters that characterize the progression of GA, and to see if these correlate with genetic or lifestyle factors.","whoItsFor":["Ages 55 Years to any","Participants with bilateral GA secondary to AMD as confirmed by the Central Reading Center using FAF and/or OCT images with at least 1 eye having a total GA lesion area must be between 1.25 mm2 and 17.5 mm2 inclusive, determined by FAF images taken at the screening visit","Best-corrected visual acuity (BCVA) in both eyes should be sufficient to ensure navigational vision (defined as 20/400 or better for purposes of this study)","BCVA between 20 and 75 letters and LLVA\\>0 letters using an ETDRS chart","Mean retinal sensitivity as measured by microperimetry using the study grid must be equal to or greater than 5 dB"],"whoShouldSkip":["Macular atrophy secondary to any condition other than AMD in the study eye","Any pathology of the macula other than GA secondary to AMD and other changes consistent with early, intermediate or atrophic AMD in the study eye","Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye","Atrophic retinal disease of causality other than AMD including monogenetic macular dystrophies (incorporating pattern dystrophy), myopia-related maculopathy and Stargardt disease in the study eye","A history of vitrectomy in the study eye","Any prior treatment for AMD or any prior intravitreal treatment for any indication in the study eye, except oral supplements of vitamins and minerals such as the age-related eye disease study (AREDS) formula","Any intraocular surgery (except cataract surgery within 6 months of enrollment) or thermal laser within 3 months of screening, or any ophthalmic condition that may require surgery during the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 75 people at 19 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.153Z"},{"nctId":"NCT07144163","title":"A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia","officialTitle":"A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Crinetics Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.","conditions":["Congenital Adrenal Hyperplasia","Classic Congenital Adrenal Hyperplasia"],"keywords":["Congenital Adrenal Hyperplasia","CAH","CRN04894","Atumelnant","Adult","Calm-CAH"],"interventions":[{"type":"DRUG","name":"Atumelnant"},{"type":"DRUG","name":"Placebo"}],"enrollment":150,"startDate":"2025-12-11","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female, between ≥18 to \\<75 years of age at the time of signing the ICF.\n2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.\n3. Have classic CAH due to 21-OHD confirmed by the Investigator.\n4. Participants with Visit 2 levels of morning serum A4 as follows:\n\n   * A4 \\>ULN and treated with \\<11 mg/m2/day (physiologic) GC doses\n   * OR normal A4 (\\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses\n   * OR A4 \\>ULN and treated with ≥11 mg/m2/day GC doses.\n5. On a stable (defined as no dose change of \\>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.\n6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.\n7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.\n\nExclusion Criteria:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.\n3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.\n4. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.\n5. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n6. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.\n7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.\n8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.\n9. Severe erythrocytosis as judged by the Investigator.\n10. 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replacement."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","aurora-colorado","gainesville-florida","atlanta-georgia","chicago-illinois","baltimore-maryland","ann-arbor-michigan","minneapolis-minnesota","rochester-minnesota","new-brunswick-new-jersey","philadelphia-pennsylvania","pittsburgh-pennsylvania","dallas-texas","charlottesville-virginia","milwaukee-wisconsin","buenos-aires-argentina","caba-argentina","c-rdoba-argentina","herston-australia","woolloongabba-australia","adelaide-australia","parkville-australia","nedlands-australia","graz-austria","vienna-austria","fortaleza-brazil","bras-lia-brazil","belo-horizonte-brazil","curitiba-brazil","rio-de-janeiro-brazil","porto-alegre-brazil","botucatu-brazil","campinas-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","halifax-canada","angers-france","bron-france","nantes-france","paris-france","pessac-france","vand-uvre-l-s-nancy-france","munich-germany","essen-germany","w-rzburg-germany","genova-italy","milan-italy","rozzano-italy","modena-italy","padova-italy","palermo-italy","naples-italy","roma-italy","hiroshima-japan","asahikawa-japan","kobe-japan","bunkyo-ku-japan","fuchu-shi-japan","setagaya-ku-japan","shinjuku-ku-japan","leiden-netherlands","nijmegen-netherlands","poznan-poland","warsaw-poland","lodz-poland","dammam-saudi-arabia","riyadh-saudi-arabia","jeddah-saudi-arabia","gothenburg-sweden","stockholm-sweden","cardiff-united-kingdom","birmingham-united-kingdom","london-united-kingdom","manchester-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Atumelnant for Congenital Adrenal Hyperplasia","inPlainEnglish":"This study wants to measure the how well it works, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.","whoItsFor":["Ages 18 Years to 74 Years","Male or female, between ≥18 to \\<75 years of age at the time of signing the ICF","Have classic CAH due to 21-OHD confirmed by the Investigator","Participants with Visit 2 levels of morning serum A4 as follows:","A4 \\>ULN and treated with \\<11 mg/m2/day (physiologic) GC doses","OR normal A4 (\\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses","OR A4 \\>ULN and treated with ≥11 mg/m2/day GC doses","If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range"],"whoShouldSkip":["Diagnosis of any form of CAH other than classic 21-OHD","History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy","Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH","History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ","Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study","Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients","Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator"],"whatHappens":"If you join, the listed intervention(s) are Atumelnant, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 150 people at 75 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.778Z"},{"nctId":"NCT07144683","title":"Anastomotic Leakage After Colorectal Surgery.","officialTitle":"Risk Factors for Anastomotic Leakage After Colorectal Surgery.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Minia University","sponsorClass":"OTHER","summary":"Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center observational cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model. Approximately 430 patients undergoing colorectal resection with anastomosis will be enrolled from August 2025 to August 2026. Risk factors will be assessed preoperatively, intraoperatively, and postoperatively. AL will be defined and graded per the International Study Group of Rectal Cancer (ISGRC) criteria.","conditions":["Anastomotic Leak","Colorectal Cancer","Diverticulitis"],"keywords":["Anastomotic leakage","Colorectal surgery","Risk factors","Postoperative complications","Predictive model"],"interventions":[{"type":"PROCEDURE","name":"Patients Undergoing Colorectal Resection with Anastomosis"}],"enrollment":430,"startDate":"2025-08-25","completionDate":"2027-03-25","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥18 years\n* Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)\n* Providing written informed consent\n\nExclusion Criteria:\n\n* Colorectal resection without anastomosis (e.g., end stoma)\n* Inflammatory bowel disease (Crohn's, ulcerative colitis)\n* History of previous colorectal surgery involving anastomosis\n* Pregnancy\n* Unable to provide informed consent or comply with follow-up","locations":[{"facility":"Minia University Hospital","city":"Minya","state":"Minya Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Saleh K Saleh, MD","phone":"01201765401","email":"salehkhairy@mu.edu.eg"}],"primaryOutcomes":["Incidence of Anastomotic Leakage (AL)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":[],"locationSlugs":["minya-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Patients Undergoing Colorectal Resection with Anastomosis for Anastomotic Leak","inPlainEnglish":"Anastomotic leakage (AL) is a severe complication after colorectal surgery, with incidence rates of 2-30%. This prospective, single-center watch-and-measure (no experimental treatment required) cohort study aims to identify and quantify independent risk factors for AL, determine its incidence and impact on outcomes, and develop a predictive model.","whoItsFor":["Ages 18 Years to 80 Years","Undergoing elective or emergency colorectal resection with primary anastomosis (e.g., ileocolic, colocolic, colorectal, coloanal)"],"whoShouldSkip":["Colorectal resection without anastomosis (e.g., end stoma)","Inflammatory bowel disease (Crohn's, ulcerative colitis)","History of previous colorectal surgery involving anastomosis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 430 people at Minya. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.056Z"},{"nctId":"NCT07144800","title":"Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)","officialTitle":"Family COMIDA (Consumo de Opciones Más Ideales De Alimentos) (Eating More Ideal Food Options)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to determine the most effective family-centered intervention (FCI) for weight loss and obesity prevention in Hispanic families. FCI is a type of program that involves family (such as parents and caregivers) supporting their children to promote healthy habits.","conditions":["Obesity","Child Obesity","Weight Loss"],"keywords":["child obesity","obesity","weight loss","Memorial Sloan Kettering Cancer Center","25-003"],"interventions":[{"type":"BEHAVIORAL","name":"Parent Weekly Individual Telephone Support"},{"type":"BEHAVIORAL","name":"Child Education"},{"type":"BEHAVIORAL","name":"Parent Initial Counseling"},{"type":"BEHAVIORAL","name":"Parent Monthly Group Support"}],"enrollment":1319,"startDate":"2025-08-26","completionDate":"2029-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPhase 1\n\n* Age \\>= 18 years (per self-report)\n* Self-identifies as Hispanic/Latino (per self-report)\n* Seeking, or has used, services at the VDS or MHU (per self-report)\n* Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)\n* Screens as obese (BMI \\> 30 kg/m2) or overweight (BMI of 25 - 29.9 kg/m2) (per height and weight measurement in person or per self-report)\n* Owns a cell phone capable of receiving text messages (per self-report)\n* Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)\n* Agrees to be audio-recorded (per self-report)\n\nPhase 2 (parent participants)\n\n* Age \\>= 18 years (per self-report)\n* Self-identifies as Hispanic/Latino (per self-report)\n* Seeking, or has used, services at the VDS or MHU (per self-report)\n* Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)\n* Screens as obese (BMI \\> 30 kg/m2) or overweight (BMI of 25 - 29.9 kg/m2) (per height and weight measurement in person or remotely)\n* Owns a cell phone capable of receiving text messages (per self-report)\n* Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)\n* Agrees to be audio-recorded (per self-report)\n\nPhase 2 (child participants)\n\n* Age 8-12 years (per parent self-report)\n* Has a parent or primary caregiver who is eligible and participating in Phase 2 (per parent self-report)\n\nExclusion Criteria:\n\nPhase 1\n\n* Is pregnant or might be pregnant (per self-report)\n* Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with hypertension and diabetes mellitus may still participate) that may affect diet and study participation (per self-report)\n* Has dietary restrictions, i.e. liquid diet, that may affect diet and study participation (per self-report)\n* Has a household member who has already participated or agreed to participate in this study program (per self-report)\n* Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups\n* Works for or with the VDS or MHU (per self-report)\n* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per study team)\n\nPhase 2 (parent participant)\n\n* Is pregnant or might be pregnant (per self-report)\n* For women, is lactating (per self-report)\n* Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with hypertension and diabetes mellitus may still participate) that may affect diet and study participation (per self-report)\n* Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per self-report)\n* Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (increasing step counts; per self-report)\n* Has a household member who has already participated or agreed to participate in this study program (per self-report)\n* Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups\n* Works for or with the VDS or MHU (per self-report)\n* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per study team)\n* Has been prescribed Ozempic, Wegovy, Mounjaro, Rybelsus, Trulicity (or other GLP 1 receptor agonist), or any other drug to treat obesity (per self-report) or (if previously prescribed) 7 weeks have not passed since the last dose was taken.\n* Has undergone weight loss/bariatric surgery (RYBG, gastric banding, sleeve gastrectomy, balloon, etc.) or is planning to undergo such surgery in the next 12 months (per self-report)\n\nPhase 2 (child participant)\n\n* Has dietary restrictions, i.e., liquid diet, that may affect diet and study participation (per parent self-report)\n* Has physical activity restrictions, i.e., handicapped or mobility issues, that may affect physical activity participation (per parent self-report)\n* Has an eating disorder (per parent self-report)\n* Is underweight (per parent self-report)","locations":[{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Leng, MD, MPH","phone":"646-888-8057","email":"lengj@mskcc.org"},{"name":"Francesca Gany, MD, MS","phone":"646-888-8054","email":"ganyf@mskcc.org"}],"primaryOutcomes":["Percentage weight loss from baseline among participants"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Parent Weekly Individual Telephone Support for Obesity","inPlainEnglish":"This study wants to determine the most effective family-centered intervention (FCI) for weight loss and obesity prevention in Hispanic families. FCI is a type of program that involves family (such as parents and caregivers) supporting their children to promote healthy habits.","whoItsFor":["Ages 18 Years to any","Age \\>= 18 years (per self-report)","Self-identifies as Hispanic/Latino (per self-report)","Seeking, or has used, services at the VDS or MHU (per self-report)","Is the parent or primary caregiver for at least one child aged 8-12 living in their household (per self-report)","Screens as obese (body-mass index (BMI) \\> 30 kg/m2) or overweight (body-mass index (BMI) of 25 - 29.9 kg/m2) (per height and weight measurement in person or per self-report)","Owns a cell phone capable of receiving text messages (per self-report)","Owns an internet connected device (e.g. cell phone, tablet, etc.) capable of conducting videoconference calls (per self-report)"],"whoShouldSkip":["Is pregnant or might be pregnant (per self-report)","Presence of a chronic disease such as cancer, kidney disease, liver disease, etc. (individuals with hypertension and diabetes mellitus may still participate) that may affect diet and study participation (per self-report)","Has dietary restrictions, i.e. liquid diet, that may affect diet and study participation (per self-report)","Has a household member who has already participated or agreed to participate in this study program (per self-report)","Prior participation in one of our preliminary studies, e.g., COMIDA, SANOS, Family COMIDA (per self-report) and any related focus groups","Works for or with the VDS or MHU (per self-report)","Phase 2 (parent participant)"],"whatHappens":"If you join, the listed intervention(s) are Parent Weekly Individual Telephone Support, Child Education, or Parent Initial Counseling. The registry lists allocation as randomized. This study wants to determine the most effective family-centered intervention (FCI) for weight loss and obesity prevention in Hispanic families.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,319 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.822Z"},{"nctId":"NCT07145411","title":"HPC Offered for PRESERVE Expansion","officialTitle":"A Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for HOPE Patients With Hematologic Malignancies or Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ossium Health, Inc.","sponsorClass":"INDUSTRY","summary":"Ossium recognizes that not all patients who could benefit from Ossium's HPC, Marrow can access the PRESERVE trial for logistical or eligibility reasons. The HOPE program is expanded access program to serve these patients by providing our bone marrow product","conditions":["Bone Marrow Transplant (BMT)"],"keywords":["Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Lymphomas","Chronic lymphoblastic Leukemia","Chronic Myeloid Leukemia","myelodysplastic syndrome","stem cell transplant","severe aplastic anemia","Sickle cell anemia","Thalessemia"],"interventions":[{"type":"OTHER","name":"Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors)"}],"enrollment":10,"startDate":"2024-06-27","completionDate":"2027-08","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatients aged 12-80 may be eligible\\* to receive bone marrow for transplantation through the Ossium HOPE Program if:\n\nTheir treating physician determined they are eligible for allogeneic bone marrow transplant Their treating physician determined that the potential benefit outweighs the potential risks","locations":[{"facility":"University of Alabama, Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tristar Centennial Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Preethi Prasad, Senior Director Clinical Operations","phone":"415-513-5535","email":"preethi.prasad@ossiumhealth.com"}],"primaryOutcomes":["Neutrophil engraftment"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","duarte-california","detroit-michigan","columbus-ohio","nashville-tennessee"],"enrichment":{"headline":"Not a traditional drug phase: Bone Marrow Transplant with Ossium's HPC, Marrow (bone marrow recovered from deceased organ and tissue donors) for Bone Marrow Transplant (BMT)","inPlainEnglish":"Ossium recognizes that not all patients who could benefit from Ossium's HPC, Marrow can access the PRESERVE trial for logistical or eligibility reasons. The HOPE program is expanded access program to serve these patients by providing our bone marrow product","whoItsFor":["Ages 12 Years to 80 Years","Patients aged 12-80 may be eligible\\* to receive bone marrow for transplantation through the Ossium HOPE Program if:","Their treating physician determined they are eligible for allogeneic bone marrow transplant Their treating physician determined that the potential benefit outweighs the potential risks"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 10 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.833Z"},{"nctId":"NCT07148245","title":"Symptoms of Immune Checkpoint Inhibitor Therapy in Cutaneous Melanoma","officialTitle":"Characterization of the Symptom Experience of Patients With Cutaneous Melanoma Receiving Immune Checkpoint Inhibitor Therapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences. An in-depth characterization of inter-individual differences in patients' symptom experiences will fill this knowledge gap and assist with the early detection of ICI toxicity; guide symptom management; inform treatment decision making; and refine ICI-symptom instrument development. Furthermore, given the limited knowledge in this area, the identification of demographic, clinical, environmental, and molecular risk factors associated with a worse symptom experience is warranted. This is a longitudinal, prospective study evaluating the symptoms that immune checkpoint inhibitors may cause in patients with cutaneous melanoma.","conditions":["Cutaneous Melanoma","Cutaneous Melanoma, Stage III","Cutaneous Melanoma by AJCC V7 Stage","Cutaneous Melanoma, Stage IV"],"keywords":["Toxicity"],"interventions":[{"type":"PROCEDURE","name":"Blood Sample"},{"type":"OTHER","name":"Health Related Quality of Life Questionnaires (HRQoL)"},{"type":"OTHER","name":"Medical Chart Review"}],"enrollment":300,"startDate":"2025-10-13","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥18 years of age\n* Able to speak and read English\n* Diagnosed with stage IIB, III, or IV cutaneous melanoma\n* Participants who are scheduled to receive \\>=1 immune checkpoint inhibitor at University of California San Francisco medical center locations. Participants on targeted therapies (e.g., BRAF or mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors) will be eligible.\n* Provide written informed consent to participate in this study.\n* Participants with stage IIB or higher cutaneous melanoma\n\nExclusion Criteria:\n\n* Participants will be excluded if they are unable to complete study requirements.","locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erin Hubbard, MPH","phone":"(415) 502-7774","email":"Erin.Hubbard@ucsf.edu"},{"name":"Carolyn Harris, PhD, RN","phone":"","email":"Carolyn.Harris@ucsf.edu"}],"primaryOutcomes":["Frequency of symptoms reported over time","Number of distinct symptom profiles identified","Number of risk factors identified with worse symptom profile over time."],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Not a traditional drug phase: Blood Sample for Cutaneous Melanoma","inPlainEnglish":"The introduction of immune checkpoint inhibitors (ICIs) for the treatment of patients with stages IIB to IV cutaneous melanoma resulted in dramatic improvements in mortality rates for this common form of cancer. With this rapid shift in treatment, significant gaps in knowledge exist regarding the impact of ICIs on patients' symptom experiences.","whoItsFor":["Ages 18 Years to any","Adults ≥18 years of age","Able to speak and read English","Diagnosed with stage IIB, III, or IV cutaneous melanoma","Participants with stage IIB or higher cutaneous melanoma"],"whoShouldSkip":["you would be excluded if they are unable to complete study requirements"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at San Francisco. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.800Z"},{"nctId":"NCT07149090","title":"Lenvatinib in Combination With Nivolumab Plus Chemotherapy in Metastatic Gastric Cancer Patients With Malignant Ascites","officialTitle":"A Clinical Trial Evaluating the Efficacy and Safety of Lenvatinib, Nivolumab, and Chemotherapy in Metastatic Gastric Cancer With Malignant Ascites.","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Asan Medical Center","sponsorClass":"OTHER","summary":"To investigate efficacy and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.","conditions":["STOMACH NEOPLASM","Gastric Cancer","Gastric Cancer Adenocarcinoma Metastatic"],"keywords":["Stomach Neoplasms","Gastric cancer","Lenvatinib","Advanced Gastric Cancer"],"interventions":[{"type":"DRUG","name":"Lenvatinib"}],"enrollment":61,"startDate":"2025-11-11","completionDate":"2027-07-30","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma\n2. Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)\n3. PD-L1 combined positive score of ≥5 based on the 28-8 assay\n4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations\n5. Age \\> 19 years at time of study entry\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Life expectancy of \\> 4 months\n8. Body weight \\> 30kg\n9. No existing neuropathy\n10. Adequate normal organ and marrow function as defined below:\n\n    * Hemoglobin ≥9.0 g/dL\n    * Absolute neutrophil count (ANC) 1.5 x (\\> 1500 per mm3)\n    * Platelet count ≥100 (or 75) x 109/L (\\>75,000 per mm3)\n    * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)\n    * AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN\n    * Measured creatinine clearance (CL) \\> 40 mL/min or Calculated creatinine CL\\>40 mL/min by the Cockcroft-Gault formula or by 24-hour urine collection for determination of creatinine clearance:\n11. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre- menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n12. Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up\n\nExclusion Criteria:\n\n1. Disease progression within 6 months after completion of adjuvant chemotherapy.\n2. Participation in another clinical study with an investigational product during the last 2 weeks\n3. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study\n4. Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable\n5. Major surgical procedure within 28 days prior to the first dose\n6. Unable to take medication orally\n7. Gastrointestinal bleeding\n8. Impaired bowel absorption\n9. History of allogenic organ transplantation\n10. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring adverse events (AEs) or compromise the ability of the patient to give written informed consent\n11. History of another primary malignancy except for\n\n    * Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose and of low potential risk for recurrence\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n    * Adequately treated carcinoma in situ without evidence of disease\n12. History of active primary immunodeficiency\n13. Active infectious disease\n14. Tuberculosis (based on clinical history, physical examination, radiographic findings, and TB testing in line with local practice)\n15. Hepatitis B (known positive HBV surface antigen (HBsAg) result)\n16. Hepatitis C (patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA)\n17. Human immunodeficiency virus (positive HIV 1/2 antibodies)\n18. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n19. Female patients who are pregnant or breastfeeding, as well as male or female patients of reproductive potential who are not willing to use effective contraception from the time of screening until 5 months following the final dose of lenvatinib.\n20. Known allergy or hypersensitivity to the investigational drug or any of its components.\n21. Patients with known deficiency of dihydropyrimidine dehydrogenase (DPD).\n22. Patients with known hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.","locations":[{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hyung-Don Kim","phone":"82-2-3010-0236","email":"kimhdmd@amc.seoul.kr"},{"name":"Jaewon Hyung","phone":"82-2-3010-1464","email":"musicine123@gmail.com"}],"primaryOutcomes":["Phase 1b part: Recommend phase 2 dose(RP2D)","Phase II part: 6 month progression-free survival (PFS) rate"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["seoul-south-korea"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Lenvatinib for STOMACH NEOPLASM","inPlainEnglish":"To investigate how well it works and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.","whoItsFor":["Ages 19 Years to any","Newly diagnosed pathologically proven metastatic, unresectable or recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma","Positive for peritoneal metastasis and grade ≥ 2 malignant ascites as confirmed by computed tomography (CT)","PD-L1 combined positive score of ≥5 based on the 28-8 assay","Age \\> 19 years at time of study entry","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Life expectancy of \\> 4 months","Body weight \\> 30kg"],"whoShouldSkip":["Disease progression within 6 months after completion of adjuvant chemotherapy","Participation in another clinical study with an investigational product during the last 2 weeks","Concurrent enrollment in another clinical study, unless it is an watch-and-measure (no experimental treatment required) (non-treatment) clinical study or during the follow-up period of an treatment study","Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable","Major surgical procedure within 28 days prior to the first dose","Unable to take medication orally","Gastrointestinal bleeding"],"whatHappens":"If you join, the listed intervention(s) are Lenvatinib. The registry lists allocation as na. To investigate how well it works and safety of lenvatinib in combination with nivolumab plus chemotherapy in gastric cancer patients with peritoneal metastasis and grade ≥ 2 ascites.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 61 people at Seoul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.987Z"},{"nctId":"NCT07149857","title":"A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel","officialTitle":"A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cilta-cel"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Induction therapy"},{"type":"DRUG","name":"Fludarabine"}],"enrollment":60,"startDate":"2025-10-03","completionDate":"2028-04-12","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Documented diagnosis of newly diagnosed multiple myeloma (NDMM) according to the most recent international myeloma working group (IMWG) diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy): Serum monoclonal paraprotein (M-protein) level greater than equal to (\\>=)1.0 grams per deciliter (g/dL) or urine M-protein level \\>= 200 milligrams (mg)/24 hours; or light chain multiple myeloma in whom the only measurable disease is by serum free light chain (FLC) levels in the serum: involved serum free light chain \\>= 10 mg/dL and abnormal serum free light chain ratio\n* Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: (a) Advanced age; or (b) Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or (c) Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment\n* Participant must have received at least 3 cycles and no more than 5 cycles of induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled (screening can commence as early as during Cycle 3 of induction). Participants must have achieved \\>= partial response (PR) on the most recent disease assessment to be enrolled\n* Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1\n* Must be willing and able to adhere to the lifestyle restrictions specified in the protocol\n\nExclusion Criteria\n\n* Frailty index of \\>= 2 according to Myeloma Geriatric Assessment score\n* Known allergies, hypersensitivity, or intolerance to study intervention or its active agents\n* Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib\n* Participants who require continuous supplemental oxygen","locations":[{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospital and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health","city":"Charlotte","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Baptist Medical Center (WFUBMC) - Comprehensive Cancer Center","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Prince Alfred Hospital","city":"Camperdown","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Medical Centre","city":"Clayton","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Hospital","city":"Heidelberg","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital","city":"Murdoch","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital","city":"Woolloongabba","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. Germans Trias I Pujol","city":"Badalona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Univ Vall D Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Univ. de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Clinico Univ de Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. Marques de Valdecilla","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Virgen Del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Minimal Residual Disease (MRD)-negative Complete Response (CR) After Cilta-cel Infusion"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["san-francisco-california","tampa-florida","iowa-city-iowa","new-york-new-york","charlotte-north-carolina","winston-salem-north-carolina","cleveland-ohio","camperdown-australia","clayton-australia","heidelberg-australia","murdoch-australia","woolloongabba-australia","badalona-spain","barcelona-spain","madrid-spain","pamplona-spain","salamanca-spain","santander-spain","seville-spain"],"enrichment":{"headline":"Phase 2: testing Cilta-cel for Multiple Myeloma","inPlainEnglish":"This study wants to evaluate how well (how well it works) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.","whoItsFor":["Ages 18 Years to 80 Years","Eastern cooperative oncology group (ECOG) Performance Status score of 0 or 1","Must be willing and able to adhere to the lifestyle restrictions specified in the protocol"],"whoShouldSkip":["Frailty index of \\>= 2 according to Myeloma Geriatric Assessment score","Known allergies, hypersensitivity, or intolerance to study intervention or its active agents","Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib","Participants who require continuous supplemental oxygen"],"whatHappens":"If you join, the listed intervention(s) are Cilta-cel, Cyclophosphamide, or Induction therapy. The registry lists allocation as na. This study wants to evaluate how well (how well it works) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.516Z"},{"nctId":"NCT07151937","title":"A Study of LAD191 in Adults With Hidradenitis Suppurativa","officialTitle":"A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Almirall, S.A.","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to assess the efficacy of multiple dosing regimens of LAD191 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.","conditions":["Hidradenitis Suppurativa"],"keywords":[],"interventions":[{"type":"DRUG","name":"LAD191"},{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"Adalimumab"}],"enrollment":200,"startDate":"2025-11-05","completionDate":"2027-05-25","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged greater than or equal to (\\>=) 18 to less than or equal to (\\<=) 65 years.\n* A diagnosis of moderate-to-severe HS defined as a total of \\>= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months.\n* HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits.\n* History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit.\n* Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study.\n* Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study.\n\nExclusion Criteria:\n\n* HS with \\>20 draining tunnels at the Screening or Baseline/Day 1 visit.\n* Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study.\n* Known hypersensitivity to LAD191 or any of its excipients.\n* Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment.\n* Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment.\n* Prior treatment with LAD191.\n* Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* Intention to use any concomitant medication or therapy that is not permitted by this protocol or failure to meet the required washout period for a particular prohibited medication prior to Baseline/Day 1.","locations":[{"facility":"Hospital de Manises","city":"Manises","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Victor Castellano","phone":"+34932746671","email":"gco@almirall.com"},{"name":"Estrella García","phone":"+34620985953","email":"gco@almirall.com"}],"primaryOutcomes":["Proportion of Participants Achieving 50 Percent (%) Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR-50)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["manises-spain"],"enrichment":{"headline":"Phase 2: testing LAD191 for Hidradenitis Suppurativa","inPlainEnglish":"The main purpose of this study is to assess the how well it works of multiple dosing regimens of LAD191 compared to dummy treatment (placebo) in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.","whoItsFor":["Ages 18 Years to 65 Years","Aged greater than or equal to (\\>=) 18 to less than or equal to (\\<=) 65 years","A diagnosis of moderate-to-severe HS defined as a total of \\>= 5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline/Day 1 visits, with signs and symptoms of HS for at least 6 months","HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline/Day 1 visits","History of inadequate response, intolerance, or contraindication to a course of a systemic antibiotics for treatment of HS at the screening visit","Regular use of over-the-counter topical antiseptics on HS lesions and agrees to regular use, throughout the entirety of the study","Participants who are women of child-bearing potential (WOBCP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD191 during the study"],"whoShouldSkip":["HS with \\>20 draining tunnels at the Screening or Baseline/Day 1 visit","Ongoing medical conditions requiring systemic immunosuppressive/immunomodulating treatments during the study","Known hypersensitivity to LAD191 or any of its excipients","Known hypersensitivity to adalimumab or biosimilar or any of its excipients or meeting any warning or contraindication to adalimumab treatment as per the approved product information, and as per the Investigator's judgment","Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy, regardless of indication, that was clinically significant, as per the Investigator's judgment","Prior treatment with LAD191","Live or attenuated vaccinations 4 weeks prior to Baseline/Day 1 or is planning to receive any such vaccine during the study"],"whatHappens":"If you join, the listed intervention(s) are LAD191, Placebo, or Adalimumab. The registry lists allocation as randomized. The main purpose of this study is to assess the how well it works of multiple dosing regimens of LAD191 compared to dummy treatment (placebo) in participants with moderate-to-severe Hidradenitis Suppurativa (HS) and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at Manises. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.272Z"},{"nctId":"NCT07153055","title":"Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","officialTitle":"Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Misty Shields","sponsorClass":"OTHER","summary":"This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).","conditions":["Small Cell Lung Cancer ( SCLC )","Transformed Small Cell Lung Cancer"],"keywords":["EGFR mutations"],"interventions":[{"type":"DRUG","name":"Lurbinectedin"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":16,"startDate":"2027-01","completionDate":"2029-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. ≥ 18 years old at the time of informed consent.\n2. Ability to provide written informed consent and HIPAA authorization.\n3. Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer.\n4. Must have an initial diagnosis of EGFR altered (EGFR-mutated) non-small cell lung cancer and received EGFR targeted therapy (TKI) osimertinib, and does not demonstrate evidence of acquired molecular underpinnings (i.e., presence of a MET amplification \\>6 copies or EGFR C797S) resulting in progression on osimertinib, aside from histologic transformation to small cell lung cancer. Interruptions of osimertinib prior to enrollment on study is permitted.\n\n   Note: Tissue specimens from archival tissue are encouraged but not required for enrollment.\n5. Patients who have received platinum (cisplatin or carboplatin)/etoposide after histologic transformation are permitted on study. Receipt of last cycle of therapy should be at least 3 weeks prior to initiation of treatment on study. Last exposure to immunotherapy such as anti-PD-L1 should be at least four weeks from treatment to initiation of treatment on study. Patients who decline to receive platinum/etoposide after SCLC transformation, for personal preferences or considered medical ineligible for this regimen, may be considered for this study, subject to investigator discretion.\n6. Must have measurable disease per RECIST (version 1.1).\n7. ECOG performance status ≤ 2.\n8. Adequate laboratory functions on baseline testing within 21 days of enrollment, as defined as:\n\n   a. Hematologic parameters: i. Absolute neutrophil count (ANC) ≥ 1.5x109/L ii. Platelet count (Plt) ≥ 100x109/L b. Hepatic parameters: i. Total bilirubin ≤ 1.5x upper limit of normal (ULN); for patients with suspected/documented Gilbert's syndrome, total bilirubin ≤ 3x ULN.\n\n   ii. AST ≤ 3x ULN. iii. ALT ≤ 3x ULN. c. Renal parameters: i. Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR, calculated per institutional standards) should be \\> 30 mL/min.\n9. Women of childbearing potential must have a negative pregnancy test within 21 days of protocol registration. Women are considered to have childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) unless they meet one of the following criteria:\n\n   i. Has achieved menarche at some point; or ii. Has not undergone a hysterectomy or bilateral oophorectomy; or iii. Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n10. Women of childbearing potential and men with any partners of child-bearing potential must agree to use 2 forms of effective contraception throughout the study and for 6 months after the last study treatment.\n\n    Note: Acceptable methods of birth control include abstinence, partner with previous vasectomy, placement of an intrauterine device (IUD), condom with spermicidal foam/gel/film/cream/suppository, diaphragm or cervical vault cap, or hormonal birth control (pills or injections).\n11. Male subjects must agree to refrain from donating sperm during the study and for 6 months after the last study treatment. Female subjects must agree to refrain from donating eggs during the study and for 6 months after the last study treatment.\n\nExclusion Criteria\n\n1. Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC.\n2. Patients who are pregnant (treatment can cause fetal harm) and/or breastfeeding.\n3. Symptomatic or unstable brain metastases, requiring \\> 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment.\n4. Patients with known history of interstitial lung disease (ILD) or pneumonitis (\\> grade 1) or ILD/pneumonitis (\\> grade 1) related to antineoplastic drug treatment.\n5. Prior history of documented Stephen Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme major (EMM), or aplastic anemia on osimertinib.\n6. History of congenital long QTc syndrome or mean resting QTc \\>500 msec at screening with two replicated EKGs at baseline screening for the study.\n7. History of ongoing unstable or uncontrolled cardiac conditions, including documented cardiomyopathy or symptomatic congestive heart failure (defined as New York Heart Association (NYHA) class III or IV).\n8. Prior history of documented severe allergic or anaphylactic reaction to osimertinib.\n9. Prior history of documented aplastic anemia with osimertinib.\n10. Prior history of documented allergic or anaphylactic reactions to inactive ingredients of lurbinectedin, including sucrose, lactic acid, and sodium hydroxide.","locations":[{"facility":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lori Tyson, RN","phone":"317-274-0895","email":"lotyson@iu.edu"}],"primaryOutcomes":["Grade 3 or dose-limiting toxicities"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["indianapolis-indiana"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Lurbinectedin for Small Cell Lung Cancer ( SCLC )","inPlainEnglish":"This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).","whoItsFor":["Ages 18 Years to any","Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer","Note: Tissue specimens from archival tissue are encouraged but not required for enrollment","Must have measurable disease per RECIST (version 1.1)","how well you can do daily activities (ECOG score) ≤ 2","Adequate laboratory functions on baseline testing within 21 days of enrollment, as defined as:","a. Hematologic parameters: i. Absolute neutrophil count (ANC) ≥ 1.5x109/L ii. Platelet count (Plt) ≥ 100x109/L b. Hepatic parameters: i. Total bilirubin ≤ 1.5x upper limit of normal (ULN); for patients with suspected/documented Gilbert's syndrome, total bilirubin ≤ 3x ULN","ii. AST ≤ 3x ULN. iii. ALT ≤ 3x ULN. c. Renal parameters: i. Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR, calculated per institutional standards) should be \\> 30 mL/min"],"whoShouldSkip":["Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC","Patients who are pregnant (treatment can cause fetal harm) and/or breastfeeding","Symptomatic or unstable brain metastases, requiring \\> 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment","Patients with known history of interstitial lung disease (ILD) or pneumonitis (\\> grade 1) or ILD/pneumonitis (\\> grade 1) related to antineoplastic drug treatment","Prior history of documented Stephen Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme major (EMM), or aplastic anemia on osimertinib","History of congenital long QTc syndrome or mean resting QTc \\>500 msec at screening with two replicated EKGs at baseline screening for the study","History of ongoing unstable or uncontrolled cardiac conditions, including documented cardiomyopathy or symptomatic congestive heart failure (defined as New York Heart Association (NYHA) class III or IV)"],"whatHappens":"If you join, the listed intervention(s) are Lurbinectedin, or Osimertinib. The registry lists allocation as randomized. This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 16 people at Indianapolis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.681Z"},{"nctId":"NCT07153848","title":"An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease","officialTitle":"A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"First Affiliated Hospital of Zhejiang University","sponsorClass":"OTHER","summary":"The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.","conditions":["Alzheimer Disease"],"keywords":["lecanemab","Alzheimer Disease","biomarkers","blood"],"interventions":[],"enrollment":400,"startDate":"2024-07-01","completionDate":"2027-12-31","sex":"ALL","minAge":"45 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria (all of the following must be met simultaneously):\n\nMild Alzheimer's Disease (AD):\n\n1. Age ≥ 45 years but ≤ 85 years;\n2. Literacy level of elementary school and above (i.e., ≥3 years of education);\n3. Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);\n4. Clinical Dementia Rating Scale CDR-global = 1 point;\n5. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain.\n\nAD-derived mild cognitive impairment (aMCI) inclusion criteria (must meet all of the following conditions at the same time):\n\n1. Age: 45 years or older but ≤85 years;\n2. Literacy level elementary school and above (i.e., ≥3 years of education);\n3. Meeting Peterson's 2004 diagnostic criteria for MCI:\n\n   (i) Complaint of memory impairment that can be confirmed by an informed person; (ii) objective evidence of memory impairment (memory test scores 1-1.5 standard deviations below normal controls matched for age and literacy; e.g., Huashan Hospital's recommended cut-off values for those with elementary school literacy or above are as follows: long-delayed recall 50-59 years old ≤ 5, 60-69 years old ≤ 4, 70-79 years old ≤ 3, 80-89 years old ≤ 2, or re-recognition scores of 50-59 years old ≤ 20, 60-69 age ≤19 points, 70-79 years ≤18 points, 80-89 years ≤16 points); (iii) Overall cognitive functioning was largely preserved, with CDR-global = 0.5 points and MMSE: ≥24 points for those with junior high school or higher education used in this study;\n\n   ④ Daily life ability remains normal (basically able to complete going out by transportation and shopping and counting, etc.);\n\n   ⑤ Does not meet the International Classification of Diseases Diagnostic Manual, 10th edition dementia criteria (for research purposes) and the National Institute of Neurological and Speech-Language Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) likely diagnostic criteria for AD dementia; (vi) Aβ-PET scan suggested extensive deposition of Aβ plaques in the brain.\n\nNormal control Inclusion criteria (all of the following must be met simultaneously).\n\n1. Age ≥55 years but ≤85 years;\n2. Elementary school 3 years of education and above;\n3. MMSE: ≥26 points for those with junior high school or higher education;\n4. CDR=0;\n5. Activity of Daily Living Scale (ADL) score ≤ 20;\n6. No significant deposition of Abeta in the brain as indicated by Aβ-PET scan.\n\nExclusion Criteria (excluded if any of the following conditions were met):\n\n1. Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;\n2. Presence of other neurological disorders that may cause brain dysfunction (e.g., schizophrenia, severe anxiety and depression, frontotemporal lobe dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, and normal cranial pressure hydrocephalus, etc.);\n3. Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;\n4. Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;\n5. Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);\n6. Presence of contraindications to NMR such as metal implantation in the body;\n7. Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;\n8. Refusal to sign the informed consent.","locations":[{"facility":"The First Affiliated Hospital of Zhejiang University","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Guoping Peng, PhD","phone":"13588150613","email":"pgpfc@163.com"},{"name":"Xiaoyan Liu, PhD","phone":"15824137598","email":"liuxiaoyandongda@126.com"}],"primaryOutcomes":["Number of participants with blood biomarkers"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.","whoItsFor":["Ages 45 Years to 85 Years","(all of the following must be met simultaneously):","Mild Alzheimer's Disease (AD):","Age ≥ 45 years but ≤ 85 years;","Literacy level of elementary school and above (i.e., ≥3 years of education);","Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);","Clinical Dementia Rating Scale CDR-global = 1 point;","Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain"],"whoShouldSkip":["(excluded if any of the following conditions were met):","Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;","Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;","Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;","Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);","Presence of contraindications to NMR such as metal implantation in the body;","Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.231Z"},{"nctId":"NCT07155187","title":"A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer","officialTitle":"A Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination With Osimertinib, Compared to Standard of Care in Subjects With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib compared to standard of care (SOC).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of NSCLC. This study will be divided into two stages, in the first stage (phase 2) participants will receive 1 of 2 doses of telisotuzumab adizutecan as a monotherapy or in combination with osimertinib. In the second stage (phase 3) participants will receive the recommended phase 3 dose (RP3D) of telisotuzumab adizutecan, from the previous stage, or SOC. Approximately 490 adult participants with NSCLC will be enrolled in the study in 200 sites around the world.\n\nIn phase 2, participants will receive 1 of 2 intravenous (IV) doses of telisotuzumab adizutecan as a monotherapy or in combination with oral osimertinib. In phase 3, participants will receive the IV RP3D of telisotuzumab adizutecan, or SOC. The study will run for a duration of approximately 69 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.","conditions":["Non-Small Cell Lung Cancer","c-MET"],"keywords":["Non-Small Cell Lung Cancer","Telisotuzumab Adizutecan","ABBV-400","Osimertinib","Standard of Care","Cancer","AndroMETa-Lung-713"],"interventions":[{"type":"DRUG","name":"Telisotuzumab Adizutecan"},{"type":"DRUG","name":"Standard of Care"},{"type":"DRUG","name":"Osimertinib"}],"enrollment":490,"startDate":"2025-12-10","completionDate":"2030-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation.\n* Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable.\n* Received one prior third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy in the adjuvant, locally advanced, or metastatic setting, either as monotherapy or in combination with other agents, and experienced documented radiographic disease progression on or after therapy for the most recent regimen administered prior to study entry. Participant who has received prior third-generation EGFR TKI therapy in the adjuvant setting must have progressed while on treatment.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.\n* At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated.\n\nExclusion Criteria:\n\n* Tumor(s) have adenosquamous or squamous histology or sarcomatoid features.\n* Received more than 1 line of systemic therapy in the locally advanced or metastatic setting.\n* Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable.\n* Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids.\n* Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation.","locations":[{"facility":"Highlands Oncology Group - Springdale /ID# 277132","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope National Medical Center /ID# 277005","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope - Orange County Lennar Foundation Cancer Center /ID# 277928","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health - Moores Cancer Center /ID# 278836","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Specialists of North Florida /ID# 277332","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Centers of Brevard- Rockledge /ID# 277853","city":"Rockledge","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center /ID# 276785","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkview Research Center /ID# 277651","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HealthPartners Cancer Research Center /ID# 277339","city":"Saint Louis Park","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nho - Revive Research Institute /ID# 277569","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Medical Center /ID# 277673","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Astera Cancer Care /ID# 277570","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Cancer Specialists - Knoxville - Old Weisgarber Road /ID# 277891","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners /ID# 276959","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center. /ID# 277939","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Cancer Specialists - Vancouver /ID# 277855","city":"Vancouver","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Canberra Hospital /ID# 277166","city":"Garran","state":"Australian Capital Territory","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St George Hospital - Kogarah /ID# 277168","city":"Kogarah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Misericordiae /ID# 276985","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icon Cancer Centre Hobart /ID# 277549","city":"Hobart","state":"Tasmania","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Vincent's Hospital Melbourne /ID# 277002","city":"Fitzroy","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunshine Hospital /ID# 276894","city":"St Albans","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"One Clinical Research - 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Hopital de la Cavale Blanche /ID# 277883","city":"Brest","state":"Finistere","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Lille - Institut Coeur Poumon /ID# 276868","city":"Lille","state":"Hauts-de-France","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Arnaud de Villeneuve /ID# 276872","city":"Montpellier","state":"Herault","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie /ID# 277623","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thoraxklinik-Heidelberg gGmbH /ID# 277275","city":"Heidelberg","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Wuerzburg /ID# 277213","city":"Würzburg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Giessen und Marburg GmbH /ID# 276873","city":"Marburg","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Koeln /ID# 276862","city":"Cologne","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitatsklinikum Jena /ID# 277281","city":"Jena","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Hamburg-Eppendorf /ID# 276869","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Meir Medical Center /ID# 277289","city":"Kefar Sava","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center /ID# 276748","city":"Petah Tikva","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yitzhak Shamir Medical Center /ID# 276750","city":"Tsrifin","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center /ID# 276745","city":"Ramat Gan","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus- Haifa /ID# 276746","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Europeo Di Oncologia /ID# 276788","city":"Milan","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo dei Tintori - Ospedale San Gerardo /ID# 276928","city":"Monza","state":"Monza E Brianza","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AST Pesaro Urbino - Presidio Ospedaliero Santa Croce Di Fano /ID# 277338","city":"Fano","state":"Pesaro E Urbino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Di Riferimento Oncologico /ID# 276923","city":"Aviano","state":"Pordenone","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituti Fisioterapici Ospitalieri-Istituto Nazionale Tumori Regina Elena /ID# 277296","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Isola Tiberina - Gemelli Isola /ID# 277117","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto di Candiolo Fondazione del Piemonte per l'Oncologia IRCCS /ID# 277119","city":"Candiolo","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Policlinico G. Rodolico - San Marco /ID# 277265","city":"Catania","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento /ID# 277280","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital /ID# 277240","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kitasato University Hospital /ID# 277241","city":"Sagamihara-shi","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital /ID# 277093","city":"Chuo-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wakayama Medical University Hospital /ID# 277238","city":"Wakayama","state":"Wakayama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboudumc /ID# 277639","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leids Universitair Medisch Centrum /ID# 277270","city":"Leiden","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Medisch Centrum /ID# 276989","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht /ID# 277114","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeyla /ID# 277066","city":"Poznan","state":"Greater Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia MCM Krakow /ID# 277118","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Provita Centrum Medyczne /ID# 277494","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne /ID# 277210","city":"Gdansk","state":"Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gyncentrum Sp. z o.o. /ID# 277522","city":"Sosnowiec","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude do Alto Ave, EPE /ID# 277249","city":"Guimarães","state":"Braga District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Loures-Odivelas /ID# 277223","city":"Loures","state":"Lisbon District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Matosinhos EPE /ID# 277228","city":"Senhora da Hora","state":"Porto District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Braga, EPE /ID# 277217","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Santo Antonio /ID# 277216","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Cuf Porto /ID# 277225","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Military Medical Academy /ID# 277053","city":"Belgrade","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Serbia /ID# 277051","city":"Belgrade","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Hospital Center - Bezanijska Kosa /ID# 277052","city":"Belgrade","state":"Beograd","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Nis /ID# 277200","city":"Niš","state":"Nisavski Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute For Pulmonary Diseases Of Vojvodina /ID# 277047","city":"Kamenitz","state":"Sremski Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center Kragujevac /ID# 277162","city":"Kragujevac","state":"Sumadijski Okrug","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center /ID# 277353","city":"Goyang-si","state":"Gyeonggido","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chungbuk National University Hospital /ID# 277372","city":"Cheongju-si","state":"North Chungcheong","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital /ID# 277373","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Health System Severance Hospital /ID# 277394","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center /ID# 277371","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center /ID# 277600","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Santiago /ID# 277173","city":"Santiago de Compostela","state":"A Coruna","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Parc Tauli /ID# 277177","city":"Sabadell","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d Hebron /ID# 277156","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal /ID# 277153","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre /ID# 277155","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria /ID# 277159","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia /ID# 277147","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario Lozano Blesa /ID# 277154","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital /ID# 277145","city":"Changhua","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 277138","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Chang Gung Memorial Hospital /ID# 277472","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital /ID# 277142","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mackay Memorial Hospital /ID# 277146","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Cancer Center (Ntucc) /ID# 277134","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital /ID# 277141","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linkou Chang Gung Memorial Hospital /ID# 277135","city":"Taoyuan City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sakarya Universitesi Tip Fakultesi - Korucuk Kampusu /ID# 276962","city":"Adapazarı","state":"Sakarya","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adana Sehir Hastanesi /ID# 276957","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gazi University Medical Faculty /ID# 276943","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Universitesi Tip Fakultesi Cebeci Hastanesi /ID# 276961","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liv Hospital Ankara /ID# 276950","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi /ID# 276956","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 277063","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Necmettin Erbakan Universitesi Meram Tip Fakultesi - Eski Hastane /ID# 276946","city":"Konya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsun Medical Park Hastanesi /ID# 277201","city":"Samsun","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomews Hospital - Barts Health /ID# 277301","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust - Christie Hospital /ID# 277304","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Phase 2: Objective Response (OR) Assessed by the Blinded Independent Central Review (BICR)","Phase 3: Progression-Free Survival (PFS) as assessed by the BICR"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["springdale-arkansas","duarte-california","irvine-california","la-jolla-california","jacksonville-florida","rockledge-florida","tampa-florida","fort-wayne-indiana","saint-louis-park-minnesota","lincoln-nebraska","lebanon-new-hampshire","east-brunswick-new-jersey","knoxville-tennessee","nashville-tennessee","seattle-washington","vancouver-washington","garran-australia","kogarah-australia","south-brisbane-australia","hobart-australia","fitzroy-australia","st-albans-australia","nedlands-australia","vienna-austria","anderlecht-belgium","charleroi-belgium","hasselt-belgium","leuven-belgium","li-ge-belgium","brampton-canada","guangzhou-china","nanchang-china","shanghai-china","r-mqi-china","marseille-france","brest-france","lille-france","montpellier-france","paris-france","heidelberg-germany","w-rzburg-germany","marburg-germany","cologne-germany","jena-germany","hamburg-germany","kefar-sava-israel","petah-tikva-israel","tsrifin-israel","ramat-gan-israel","haifa-israel","milan-italy","monza-italy","fano-italy","aviano-italy","rome-italy","candiolo-italy","catania-italy","verona-italy","sapporo-japan","sagamihara-shi-japan","chuo-ku-japan","wakayama-japan","nijmegen-netherlands","leiden-netherlands","rotterdam-netherlands","utrecht-netherlands","poznan-poland","krakow-poland","warsaw-poland","gdansk-poland","sosnowiec-poland","guimar-es-portugal","loures-portugal","senhora-da-hora-portugal","braga-portugal","porto-portugal","belgrade-serbia","ni-serbia","kamenitz-serbia","kragujevac-serbia","goyang-si-south-korea","cheongju-si-south-korea","seoul-south-korea","santiago-de-compostela-spain","sabadell-spain","barcelona-spain","madrid-spain","m-laga-spain","valencia-spain","zaragoza-spain","changhua-taiwan","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","taoyuan-city-taiwan","adapazar-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","konya-turkey-t-rkiye","samsun-turkey-t-rkiye","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Telisotuzumab Adizutecan for Non-Small Cell Lung Cancer","inPlainEnglish":"Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control. this study wants to assess side effects and change in disease activity of telisotuzumab adizutecan as a this drug alone or in combination with osimertinib compared to standard of care (SOC).","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed diagnosis of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with documented EGFR Exon 19 deletion or Exon21 L858R mutation","Provide recently obtained tumor tissue during Screening for c-Met immunohistochemistry (IHC) testing (and study stratification in Phase 2). If recently obtained tumor tissue is not available, archived tumor tissue is also acceptable","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1","At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated"],"whoShouldSkip":["Tumor(s) have adenosquamous or squamous histology or sarcomatoid features","Received more than 1 line of systemic therapy in the locally advanced or metastatic setting","Active/symptomatic central nervous system (CNS) metastases. Previously treated brain metastases may be included provided they are radiologically stable","Evidence of active interstitial lung disease (ILD)/pneumonitis or history of ILD or pneumonitis that required steroids","Have any clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation"],"whatHappens":"If you join, the listed intervention(s) are Telisotuzumab Adizutecan, Standard of Care, or Osimertinib. The registry lists allocation as randomized. Non-small cell lung cancer (NSCLC) is a common type of lung cancer where abnormal cells in the lungs grow out of control.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 490 people at 117 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.684Z"},{"nctId":"NCT07156994","title":"Development of Voice Biomarkers of Frequent COVID-19 and Long Covid-related Symptoms Based on Data From Users of the Long COVID Companion App","officialTitle":"Unravelling Health and Frequent Symptoms and Voice Characteristics Evolution Over Time of Users of the Long COVID Companion Application to Develop Voice Biomarkers of Frequent Long Covid-related Symptoms","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Luxembourg Institute of Health","sponsorClass":"OTHER_GOV","summary":"The LIH DDP research team focuses its research topics on vocal biomarkers and Long COVID, among others. Voice is indeed a promising tool to monitor health, as it contains many information on our health and is easy to collect.\n\nThe development of vocal biomarkers of Long COVID-related symptoms could improve the remote monitoring of the health status of people affected by this disease.\n\nThe LIH developed the Long COVID Companion (LCC) app in collaboration with the ApresJ20 Long COVID patient association in France to support patients in their daily lives. LCC app users will be invited to participate in this study to collect voice recordings at the same time as health-related data.\n\nThe objectives of this study are:\n\nPrimary objective: To develop vocal biomarker candidates for the main Long COVID symptoms (fatigue, brain fog, respiratory problems, sleep issues, stress, anxiety,..) in a population of people with Long COVID.\n\nSecondary objectives:\n\n* to assess the intra-individual longitudinal evolution of voice characteristics of people with LC\n* to assess app usability and acceptability in the long-term.","conditions":["Long COVID"],"keywords":["Long COVID","Vocal biomarkers","symptoms"],"interventions":[{"type":"OTHER","name":"No Intervention: Observational Cohort"}],"enrollment":300,"startDate":"2025-12-15","completionDate":"2028-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult (≥18 years old)\n* Male or female\n* People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not)\n* Adequate understanding of one of the study languages (English, French, German)\n* Electronically signed informed consent form\n\nExclusion Criteria:\n\n● No specific exclusion criteria","locations":[{"facility":"LIH","city":"Strassen","state":"","country":"Luxembourg","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aurélie FISCHER, PhD","phone":"00 352 26970230","email":"aurelie.fischer@lih.lu"}],"primaryOutcomes":["Fatigue level","Fatigue level","Voice features"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["strassen-luxembourg"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention: Observational Cohort for Long COVID","inPlainEnglish":"The LIH DDP research team focuses its research topics on vocal biomarkers and Long COVID, among others. Voice is indeed a promising tool to monitor health, as it contains many information on our health and is easy to collect.","whoItsFor":["Ages 18 Years to any","Adult (≥18 years old)","People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not)","Adequate understanding of one of the study languages (English, French, German)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Strassen. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.241Z"},{"nctId":"NCT07157735","title":"A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease","officialTitle":"Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Cambridge University Hospitals NHS Foundation Trust","sponsorClass":"OTHER","summary":"In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.\n\nDapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.\n\nThe goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:\n\n1. is dapansutrile safe and well-tolerated in people with Parkinson's?\n2. does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial.\n\nResearchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.\n\nParticipants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.","conditions":["Parkinson Disease"],"keywords":["Dapansutrile","Neurodegeneration","Neuroinflammation","Inflammation","NLRP3 inflammasome"],"interventions":[{"type":"DRUG","name":"dapansutrile"},{"type":"DRUG","name":"placebo"}],"enrollment":36,"startDate":"2026-02-02","completionDate":"2027-05","sex":"ALL","minAge":"50 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nTo be included in the trial, the potential participant must:\n\n* Have given written informed consent to participate.\n* Be aged between 50 and 80 years (inclusive) at the time of the screening visit.\n* Be a fluent English speaker.\n* Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease.\n* Have a disease duration of less than 5 years at the time of screening visit.\n* Have early-stage PD, defined as Hoehn and Yahr stage ≤2.\n* Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline.\n* Have hsCRP ≥ 1 mg/L on a blood test done within 2 years prior to, or at, the screening visit.\n* Have adequate organ function, as defined below (to be rechecked prior to baseline/investigational medicinal product \\[IMP\\] initiation if \\>42 days from screening visit): Haemoglobin ≥ 110 g/L; Platelet count ≥ 130 × 109/L; Neutrophil count ≥ 1.5 × 109/L; Renal function: estimated glomerular filtration rate (eGFR) \\>45 mL/min/1.73m2; Hepatic function: alanine aminotransferase (ALT) and bilirubin \\< 1.5 times the institutional upper limit of normal; Thyroid function: thyroid stimulating hormone (TSH) within normal range; or if TSH is abnormal, free T4 within normal range; Corrected calcium ≤ institutional upper limit of normal; Alkaline phosphatase (ALP) \\< 1.5 times the institutional upper limit of normal\n\nExclusion Criteria:\n\nThe presence of any of the following will preclude inclusion:\n\n* Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.\n* Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline.\n* Any previous use of rituximab or alemtuzumab at any time.\n* Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline.\n* Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \\> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week.\n* Clinically significant inflammatory or autoimmune disease.\n* Chronic or latent infection.\n* Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline.\n* Skin, solid organ or haematological malignancy which is active\\* at screening, or between screening and baseline (\\*defined as cancer which is under active management, with the exception of low-grade malignancy under observation or hormonal treatment).\n* The inability to take or swallow oral medication.\n* Parkinson's Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria.\n* A known genetic mutation associated with PD.\n* A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)/C (HCV) or syphilis.\n* Chronic liver disease.\n* Any concurrent medical or psychiatric condition or disease that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial.\n* Women of childbearing potential - female participants must be surgically sterile or be post-menopausal. (A post-menopausal state is defined as no menses for 12 months without an alternative medical cause).\n* Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after the last dose of the trial treatment.\n* Known hypersensitivity to dapansutrile or its excipients.\n* Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another interventional investigational trial. Participants currently enrolled in other observational studies may be recruited.\n* Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes.\n* Concomitant treatment with any medications that could interfere with \\[18F\\]-DPA714 binding (e.g., certain benzodiazepines), with the exception of medications which can be safely withheld for an appropriate washout period prior to imaging at the investigator's discretion.\n* Current use of any drugs of abuse or average alcohol intake of \\>21units per week over the last 3 months.\n* Any other significant disease, disability or investigation result which, in the opinion of the Chief Investigator (CI), may either put the participant at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.","locations":[{"facility":"John Van Geest Centre for Brain Repair","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Coordinator","phone":"44 1223 331160","email":"mcd68@cam.ac.uk"}],"primaryOutcomes":["Number of adverse events (AEs) recorded during the 6-month double-blind period"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["cambridge-united-kingdom"],"enrichment":{"headline":"Phase 2: testing dapansutrile for Parkinson Disease","inPlainEnglish":"In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.","whoItsFor":["Ages 50 Years to 80 Years","To be included in the trial, the potential participant must:","Be aged between 50 and 80 years (inclusive) at the time of the screening visit","Be a fluent English speaker","Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease","Have a disease duration of less than 5 years at the time of screening visit","Have early-stage PD, defined as Hoehn and Yahr stage ≤2","Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline"],"whoShouldSkip":["The presence of any of the following will preclude inclusion:","Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971","Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline","Any previous use of rituximab or alemtuzumab at any time","Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline","Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \\> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week","Clinically significant inflammatory or autoimmune disease"],"whatHappens":"If you join, the listed intervention(s) are dapansutrile, or placebo. The registry lists allocation as randomized. In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 36 people at Cambridge. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.674Z"},{"nctId":"NCT07158242","title":"A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis","officialTitle":"A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2 - 17 Years With Moderately to Severely Active Ulcerative Colitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).","conditions":["Moderately to Severely Active Ulcerative Colitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Afimkibart"}],"enrollment":100,"startDate":"2026-04-15","completionDate":"2030-03-31","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Bodyweight \\>= 10 kilogram (kg)\n* Confirmed diagnosis of UC\n* Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)\n* Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Any major surgery within 6 weeks prior to screening or a major planned surgery during the study\n* Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)","locations":[{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Connecticut Children's Medical Center","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic;Children's Institute","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Childen?s Hospital of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Digestive Specialists","city":"Harlingen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Hospital Brisbane","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Childrens Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perth Children's Hospital","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Santa Casa de Misericordia de Porto Alegre","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CECIP - Centro de Estudos Clínicos do Interior Paulista","city":"Jaú","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"BR Trials - Pesquisa Clínica","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital For Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital ZheJiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital Shanghai Jiaotong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"IATROS International","city":"Bloemfontein","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emmed Research","city":"Pretoria","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chulalongkorn University","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siriraj Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Children's Hospital","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great North Children's Hospital","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Childrens Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CA45905 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With Clinical Remission at Week 52"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["aurora-colorado","hartford-connecticut","tampa-florida","atlanta-georgia","st-louis-missouri","lake-success-new-york","new-york-new-york","cleveland-ohio","pittsburgh-pennsylvania","harlingen-texas","south-brisbane-australia","parkville-australia","nedlands-australia","porto-alegre-brazil","ja-brazil","s-o-paulo-brazil","toronto-canada","hangzhou-china","shanghai-china","bloemfontein-south-africa","pretoria-south-africa","taipei-taiwan","bangkok-thailand","birmingham-united-kingdom","cambridge-united-kingdom","newcastle-upon-tyne-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Afimkibart for Moderately to Severely Active Ulcerative Colitis","inPlainEnglish":"This Phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, multicenter, induction and maintenance study will measure the safety and how well it works of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).","whoItsFor":["Ages 2 Years to 17 Years","Bodyweight \\>= 10 kilogram (kg)","Confirmed diagnosis of UC","Moderately to severely active UC, defined as modified Mayo Score (mMS) or 5 to 9 points, including endoscopic score of 2 or 3, confirmed by centrally read endoscopy (flexible sigmoidoscopy or colonoscopy)","Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: systemic corticosteroids, immunomodulators, and/or biologic therapies as outlined in the protocol"],"whoShouldSkip":["Monogenic disorder pertaining to infant onset inflammatory bowel disease (IBD)","Current diagnosis of Crohn's disease (CD), abdominal/intrabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease","Presence of an ostomy or ileoanal pouch","Current diagnosis or suspicion of primary sclerosing cholangitis","Any major surgery within 6 weeks prior to screening or a major planned surgery during the study","Active tuberculosis (TB) infection suggested by positive TB testing, clinical symptoms, and/or chest imaging (X-ray or CT)"],"whatHappens":"If you join, the listed intervention(s) are Afimkibart. The registry lists allocation as randomized. This Phase III, randomly assigned, neither you nor the study doctors know who gets the real treatment, multicenter, induction and maintenance study will measure the safety and how well it works of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis (UC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 100 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.204Z"},{"nctId":"NCT07159763","title":"A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)","officialTitle":"A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of CD388, a Novel Long-Acting Antiviral Conjugate, for the Prevention of Influenza in Adults and Adolescents at Higher Risk of Developing Influenza Complications","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","sponsorClass":"INDUSTRY","summary":"Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025). Yearly administration of an influenza vaccine for the prevention of influenza is currently recommended. However, the real-world vaccine effectiveness varied from 10% to 60% in the general population across the years of 2004 to 2024, with effectiveness in most years below 50% (CDC 2025) and decreasing to as low as 5% in immunocompromised individuals (Hughes 2021).\n\nThe goal of this study is to learn whether MK-1406 (CD388) can help prevent the flu in people who are at higher risk of becoming seriously ill from influenza. Researchers want to find out if MK-1406 dosed at a single study visit can provide protection against influenza compared with placebo. The study will include adolescents and adults who may be more vulnerable to complications from influenza because of their age, health conditions, or weakened immune systems. Researchers will also evaluate the safety of MK-1406 and how well participants tolerate the study medicine.","conditions":["Influenza"],"keywords":["Influenza","Antiviral Agents"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"MK-1406"},{"type":"COMBINATION_PRODUCT","name":"Placebo"}],"enrollment":10000,"startDate":"2025-09-25","completionDate":"2027-06-30","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\nPrimary Stratum A (non-immunocompromised participants who have chronic stable medical conditions) and Primary Stratum B (participants who are immunocompromised either due to underlying disease or receipt of immunosuppressive medications)\n\n* Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1\n* Weight is ≥ 40 kg\n\nPrimary Stratum A only\n\n* Has a history of pulmonary disease\n* Has moderate to severe asthma, as defined by the Global Initiative for Asthma (GINA 2025)\n* Has existing cardiac disease\n* Has insulin-dependent diabetes\n* Has moderate renal impairment\n* Is ≥ 65 years of age at the time of randomization but does not meet any of the above criteria for Primary Stratum A, and is otherwise healthy\n\nPrimary Stratum B only\n\n* Has a solid tumor diagnosis AND has received chemotherapy and/or immunotherapy within 1 year of screening\n* Has a diagnosis of a hematologic malignancy within 5 years of screening AND has received any chemotherapy or biologic therapy within 1 year of screening\n* Participants who have had a solid organ transplant (SOT) must satisfy all of the following:\n\n  * Has received a kidney, liver, heart, or lung transplant more than 6 months prior to screening\n  * Is currently receiving at least two immunosuppressive medications\n* Participants who have had a hematopoietic stem cell transplant (HSCT) must satisfy at least one of the following:\n\n  * Has a history of hematopoietic stem cell transplantation (HSCT) (i.e., autologous, allogeneic, bone marrow, peripheral blood stem cell, tandem \\[peripheral blood and marrow\\]) within 1 year of screening\n  * Has a history of non-autologous HSCT with graft-versus-host disease (GvHD) requiring active treatment with immunosuppressants (e.g., systemic corticosteroids ≥1 mg/kg at screening), regardless of the duration of time since HSCT\n* Is receiving immunosuppressive medicines\n* Has received chimeric antigen receptor-modified T-cell therapy\n* Has received B-cell depleting therapies (e.g., rituximab, ocrelizumab, ofatumumab, alemtuzumab) within the 12 months prior to screening\n* Has a diagnosis of any primary immunodeficiency except immunoglobulin A (IgA) deficiency\n* Has advanced or untreated human immunodeficiency virus (HIV) infection\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to zanamivir (following administration of inhaled or intravenous formulations), monoclonal antibody (mAbs (including Fc domains)), or any of the components of CD388 or placebo\n* Has an acute (time-limited) or febrile (temperature ≥ 38.0°C \\[≥ 100.4°F\\]) illness within 7 days prior to planned dosing on Day 1\n* Has severe chronic kidney disease (CKD) or is receiving hemodialysis\n* Receipt within the past 30 days or 5 half-lives (whichever is longer) or anticipated receipt of any drug or other biologic agent (e.g., mAbs) administered for the prevention or treatment of influenza\n* Has a clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy, or platelet disorder) or medical history of significant bleeding or bruising following intramuscular or subcutaneous (SC) injections or venipuncture\n* Has previously enrolled in this study (CD388.SQ.3.06)","locations":[{"facility":"Pinnacle Research Group ( Site 0505)","city":"Anniston","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cullman Clinical Trials ( Site 0538)","city":"Cullman","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Research Institute ( Site 0575)","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Desert Clinical Research/ CCT Research ( Site 0612)","city":"Mesa","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Foothills Research Center ( Site 0591)","city":"Phoenix","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Fiel Family and Sports Medicine, PC/CCT Research ( Site 0529)","city":"Tempe","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hope Research Institute ( Site 0587)","city":"Tempe","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health ( Site 0516)","city":"Tucson","state":"Arizona","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC ( Site 0515)","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC ( Site 0743)","city":"Carlsbad","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triallogix Medical Corporation ( Site 0615)","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute of Clinical Research ( Site 0582)","city":"Garden Grove","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Eximia Clinical Research ( Site 0571)","city":"La Mesa","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Long Beach Clinical Trials, LLC ( Site 0607)","city":"Long Beach","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research, LLC ( Site 0733)","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Clinical Trials Inc. ( Site 0741)","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC ( Site 0533)","city":"Oceanside","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC ( Site 0574)","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, Inc ( Site 0518)","city":"Redding","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research ( Site 0617)","city":"San Diego","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Acclaim Clinical Research ( Site 0506)","city":"San Diego","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC ( Site 0744)","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research, Inc. ( Site 0572)","city":"Walnut Creek","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research ( Site 0611)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research ( Site 0613)","city":"Fort Collins","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Critical Care Pulmonary & Sleep Associates - CCT Research ( Site 0525)","city":"Lakewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research, LLC. ( Site 0616)","city":"Longmont","state":"Colorado","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"New England Research Associates, LLC ( Site 0558)","city":"Bridgeport","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stamford Therapeutics Consortium ( Site 0539)","city":"Stamford","state":"Connecticut","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Emerson Clinical Research Institute ( Site 0547)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Imagine Research of Palm Beach County ( Site 0509)","city":"Boynton Beach","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Innovative Research of West Florida ( Site 0596)","city":"Clearwater","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hillcrest Medical Research ( Site 0563)","city":"DeLand","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Oncology Institute of Hope and Innovation - Fort Lauderdale ( Site 0728)","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Awareness, Inc. ( Site 0524)","city":"Jupiter","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbus Clinical Services ( Site 0588)","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"South Florida Research Center, Inc ( Site 0507)","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hope Research Network-Miami ( Site 0742)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site Partners, LLC d/b/a CSP Miami ( Site 0521)","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Floridian Clinical Research, LLC ( Site 0534)","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indago Research and Health Center Inc ( Site 0725)","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research ( Site 0724)","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Behavioral Clinical Research, Inc. 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Site 0444)","city":"Bradford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St James's University Hospital ( Site 0425)","city":"Leeds","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary ( Site 0426)","city":"Leicester","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"North Manchester General Hospital ( Site 0413)","city":"Manchester","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Derriford Hospital ( Site 0417)","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Salford Royal Hospital ( Site 0419)","city":"Salford","state":"","country":"United Kingdom","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Panthera Biopartners ( Site 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Drug"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["anniston-alabama","cullman-alabama","glendale-arizona","mesa-arizona","phoenix-arizona","tempe-arizona","tucson-arizona","carlsbad-california","fullerton-california","garden-grove-california","la-mesa-california","long-beach-california","modesto-california","northridge-california","oceanside-california","pasadena-california","redding-california","san-diego-california","walnut-creek-california","denver-colorado","fort-collins-colorado","lakewood-colorado","longmont-colorado","bridgeport-connecticut","stamford-connecticut","washington-d-c-district-of-columbia","boynton-beach-florida","clearwater-florida","deland-florida","fort-lauderdale-florida","jupiter-florida","miami-florida","miami-lakes-florida","new-port-richey-florida","north-miami-florida","orlando-florida","port-orange-florida","port-saint-lucie-florida","st-petersburg-florida","west-palm-beach-florida","winter-park-florida","atlanta-georgia","stockbridge-georgia","boise-idaho","meridian-idaho","chicago-illinois","melrose-park-illinois","palos-heights-illinois","valparaiso-indiana","west-des-moines-iowa","hutchinson-kansas","lenexa-kansas","newton-kansas","louisville-kentucky","lake-charles-louisiana","new-orleans-louisiana","prairieville-louisiana","annapolis-maryland","silver-spring-maryland","burlington-massachusetts","allen-park-michigan","clarkston-michigan","dearborn-michigan","farmington-hills-michigan","southfield-michigan","mankato-minnesota","gulfport-mississippi","kansas-city-missouri","springfield-missouri","st-louis-missouri","missoula-montana","fremont-nebraska","omaha-nebraska","henderson-nevada","las-vegas-nevada","north-las-vegas-nevada","warren-township-new-jersey","albuquerque-new-mexico","brooklyn-new-york","cortland-new-york","hartsdale-new-york","rochester-new-york","the-bronx-new-york","charlotte-north-carolina","durham-north-carolina","monroe-north-carolina","morehead-city-north-carolina","salisbury-north-carolina","wilmington-north-carolina","winston-salem-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","dayton-ohio","middleburg-heights-ohio","edmond-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","yukon-oklahoma","duncansville-pennsylvania","erie-pennsylvania","horsham-pennsylvania","charleston-south-carolina","greenville-south-carolina","spartanburg-south-carolina","hendersonville-tennessee","dallas-texas","houston-texas","laredo-texas","lewisville-texas","mcallen-texas","pearland-texas","plano-texas","san-antonio-texas","bountiful-utah","salt-lake-city-utah","charlottesville-virginia","richmond-virginia","renton-washington","caba-argentina","ciudad-autonoma-de-buenos-aires-argentina","florida-argentina","buenos-aires-argentina","c-rdoba-argentina","santa-fe-argentina","botany-australia","maroubra-australia","newcastle-australia","st-leonards-australia","brisbane-australia","taringa-australia","camberwell-australia","kitakyushu-japan","maebashi-japan","kanazawa-japan","oyama-japan","arakawa-city-japan","kiyose-japan","meguro-city-japan","suginami-japan","kumamoto-japan","east-london-south-africa","port-elizabeth-south-africa","bloemfontein-south-africa","welkom-south-africa","johannesburg-south-africa","newtown-south-africa","pretoria-south-africa","pretoria-west-south-africa","durban-south-africa","ladysmith-south-africa","brits-south-africa","rustenburg-south-africa","cape-town-south-africa","paarl-south-africa","aberdeen-united-kingdom","brighton-united-kingdom","bristol-united-kingdom","high-wycombe-united-kingdom","milton-keynes-united-kingdom","peterborough-united-kingdom","truro-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","southampton-united-kingdom","london-united-kingdom","blackpool-united-kingdom","preston-united-kingdom","enfield-united-kingdom","hounslow-united-kingdom","north-finchley-united-kingdom","rochdale-united-kingdom","corby-united-kingdom","nottingham-united-kingdom","eynsham-united-kingdom","witney-united-kingdom","cardiff-united-kingdom","birmingham-united-kingdom","bradford-united-kingdom","leeds-united-kingdom","leicester-united-kingdom","manchester-united-kingdom","plymouth-united-kingdom","salford-united-kingdom","sheffield-united-kingdom","warrington-united-kingdom","york-united-kingdom"],"enrichment":{"headline":"Phase 3: MK-1406 for Influenza","inPlainEnglish":"Approximately one billion cases of seasonal influenza occur annually. Of these, 3 to 5 million illnesses are severe and responsible for up to 650,000 deaths per year (WHO 2025).","whoItsFor":["Ages 12 Years to any","The main who can join include but are not limited to the following:","Primary Stratum A (non-immunocompromised participants who have chronic stable medical conditions) and Primary Stratum B (participants who are immunocompromised either due to underlying disease or receipt of immunosuppressive medications)","Has negative rapid antigen tests for influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to dosing at Day 1","Primary Stratum A only","Has a history of pulmonary disease","Has moderate to severe asthma, as defined by the Global Initiative for Asthma (GINA 2025)","Has existing cardiac disease"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-1406, or Placebo. The registry lists allocation as randomized. Approximately one billion cases of seasonal influenza occur annually.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 10,000 people at 211 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.011Z"},{"nctId":"NCT07159789","title":"Repetitive Transcranial Magnetic Stimulation (rTMS) in MS Induced Spastic Paraparesis","officialTitle":"Non-Invasive Neuromodulation in MS Induced Spastic Paraparesis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Clinique Neuro-Outaouais","sponsorClass":"OTHER","summary":"Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.","conditions":["Multiple Sclerosis"],"keywords":["rTMS","Neuromodulation","MS Induced Spastic Paraparesis","Spastic paresis","neural synchrony","neuroplasticity"],"interventions":[{"type":"DEVICE","name":"Repetitive Transcranial Magnetic Stimulation"}],"enrollment":70,"startDate":"2025-10-15","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 18 years and less than 71 years.\n3. Diagnosis of MS according to the revised 2017 McDonald Criteria (Thompson et al. 2018).\n4. EDSS of 3.0 to 6.5 with a pyramidal functional system score of 3.0 or more.\n5. Neurologically stable with no change in symptom related medications or relapse for at least 30 days prior to screening.\n6. Patients will be allowed to continue fampridine provided they started more than 30 days prior to screening. They will not be allowed to start fampridine, any stimulant (modafenil, methylphenidate etc) or symptomatic treatment of spasticity (baclofen, tizanidine, botulinum toxin etc.) during the study.\n7. No change in disease modifying therapy for at least 3 months prior to screening.\n8. Ability to perform T25FWT, the MSQoL 6MWT Ability and willingness, in the investigator's opinion, to comply with the study protocol.\n\nExclusion Criteria:\n\n1. Know presence of other neurologic disorders, which in the opinion of the investigator could add to the patient's neurological disability within the timespan of the study.\n2. Evidence of clinically significant cardiovascular (including arrhythmias), psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the investigator's opinion, would preclude patient participation.\n3. Pregnant or breastfeeding or intending to become pregnant during the study.\n4. Any previous rTMS therapy for any indication.\n5. Presence of any contraindication to rTMS therapy such as but not limited to: CNS implanted devices, pacemaker.\n6. Any condition which in the opinion of the investigator will render the patient unsuitable to participate in the study.","locations":[{"facility":"Clinique Neuro-Outaouais","city":"Gatineau","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Francois Jacques, Neurologist","phone":"819-777-2500","email":"francois.jacques@neuro-outaouais.ca"},{"name":"Ibrahim Sangare, Nurse","phone":"819-777-2500","email":"ibrahim.sangare@neuro-outaouais.ca"}],"primaryOutcomes":["Improvement of T25FWT (Timed 25-Foot Walk Test)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["gatineau-canada"],"enrichment":{"headline":"Not a traditional drug phase: Repetitive Transcranial Magnetic Stimulation for Multiple Sclerosis","inPlainEnglish":"Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.","whoItsFor":["Ages 18 Years to 70 Years","Age ≥ 18 years and less than 71 years","Diagnosis of MS according to the revised 2017 McDonald Criteria (Thompson et al. 2018)","EDSS of 3.0 to 6.5 with a pyramidal functional system score of 3.0 or more","Neurologically stable with no change in symptom related medications or relapse for at least 30 days prior to screening","No change in disease modifying therapy for at least 3 months prior to screening","Ability to perform T25FWT, the MSQoL 6MWT Ability and willingness, in the investigator's opinion, to comply with the study protocol"],"whoShouldSkip":["Know presence of other neurologic disorders, which in the opinion of the investigator could add to the patient's neurological disability within the timespan of the study","Evidence of clinically significant cardiovascular (including arrhythmias), psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the investigator's opinion, would preclude patient participation","Pregnant or breastfeeding or intending to become pregnant during the study","Any previous rTMS therapy for any indication","Presence of any contraindication to rTMS therapy such as but not limited to: CNS implanted devices, pacemaker","Any condition which in the opinion of the investigator will render the patient unsuitable to participate in the study"],"whatHappens":"If you join, the listed intervention(s) are Repetitive Transcranial Magnetic Stimulation. The registry lists allocation as randomized. Study the impact of rTMS on walking ability in people with Multiple Sclerosis (MS) induced spastic paraparesis and moderate walking disability.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 70 people at Gatineau. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.970Z"},{"nctId":"NCT07159841","title":"A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)","officialTitle":"A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"Crinetics Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).","conditions":["Congenital Adrenal Hyperplasia","Classic Congenital Adrenal Hyperplasia"],"keywords":["Congenital Adrenal Hyperplasia","CAH","CRN04894","Atumelnant","Pediatric","Balance-CAH"],"interventions":[{"type":"DRUG","name":"Atumelnant"},{"type":"DRUG","name":"Placebo"}],"enrollment":153,"startDate":"2026-01-22","completionDate":"2030-03","sex":"ALL","minAge":"1 Year","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPart A and B participants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female at birth, between 1 to \\<18 years of chronological age at the time of signing the Informed Consent Form (ICF).\n2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency (21-OHD) based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genetic testing, positive newborn screening with confirmatory second tier testing, or cosyntropin stimulation.\n3. Participants must have an elevated morning serum A4 level \\>ULN during Screening obtained prior to morning glucocorticoid (GC) administration.\n4. Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening.\n5. Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period.\n6. Biochemical euthyroidism as determined by the Investigator.\n\nPart C inclusion criteria require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age.\n\nExclusion Criteria:\n\nPart A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. Participants treated with other GCs within 30 days of Screening.\n3. Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone.\n4. Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting.\n5. Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening.\n6. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n7. Abnormal sleep/wake cycles (as determined by the Investigator).\n8. Female participants who are pregnant or lactating.\n9. Participants who have been dosed with an investigational drug (including atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to the first dose.\n10. Individuals in Part C who do not meet the Part C Inclusion Criteria.","locations":[{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Ron Conway Gateway Medical Building","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann and Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston's Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Robert Wood Johnson Medical School","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai-Mount Sinai Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cook Children's Health Care System","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Health System","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Metabólicas","city":"Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Niños de la Santísima Trinidad","city":"Córdoba","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Especializado (IME)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEDIE \"Centro de Investigaciones Endocrinológicas\", CONICET-FEI División de Endocrinología, Hosp de Niños Ricardo Gutiérrez","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Endocrinology of Diabetes, The Children's Hospital at Westmead","city":"Westmead","state":"New South Wales","country":"Australia","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Queensland Children's Hospital","city":"South Brisbane","state":"Queensland","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Monash Children's Hospital, Monash Health","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perth Children's Hospital","city":"Nedlands","state":"Western Australia","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZA (Antwerp University Hospital)","city":"Edegem","state":"Antwerp","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc","city":"Brussels","state":"Brussels Capital","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent (University Hospital Ghent)","city":"Ghent","state":"East Flanders","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven (Universitair Ziekenhuis Leuven)","city":"Leuven","state":"Flemish Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nucleo de Pesquisa Clinica do Rio Grande do Sul","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Materno Infantil IDIMI, Facultad de Medicina de la Universidad de Chile","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital las Hilgueras de Talcahuano","city":"Talcahuano","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) d'Angers","city":"Angers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Kremlin-Bicétre - 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Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für pädiatrische Endokrinologie und Diabetologie","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Federico II","city":"Naples","state":"Campania","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Giannina Gaslini","city":"Genoa","state":"Liguria","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Meyer IRCCS","city":"Florence","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboudumc Amalia Children's Hospital, Department of Pediatrics","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny im, Jana Mikulicza-Radeckiego we Wrocławiu, Klinika Pediatrii, Endokrynologii, Diabetologii i Chorób Metabolicznych","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Dziecięcy Szpital Kliniczny im. L. Zamenhofa w Białymstoku, Klinika Pediatrii, Endokrynologii, Diabetologii z Pododdziałem Kardiologii","city":"Bialystok","state":"Podlaskie Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"lnstytut Centrum Zdrowia Matki Polki, Klinika Endokrynologii i Chor6b Metabolicznych","city":"Lodz","state":"Poland","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny Nr 1 im. Prof. Tadeusza Sokotowskiego PUM w Szczecinie, Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie","city":"Szczecin","state":"West Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Faisal Specialist Hospital & Research Center","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Saud University Medical City (KSU-MC}","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alder Hey Children's NHS Foundation Trust, Alder Hey Children's Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Ormond Street Hospital for Children NHS Foundation Trust, Great Ormond Street Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manchester University NHS Foundation Trust, Royal Manchester Children's Hospital","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Children's Hospital NHS Trust, Sheffield Children's Hospital, Western Bank","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Crinetics Clinical Trials","phone":"833-827-9741","email":"clinicaltrials@crinetics.com"}],"primaryOutcomes":["Change from baseline in morning serum androstenedione (A4) (Part A)","Percent change from baseline in glucocorticoid (GC) daily dose while serum early morning A4 ≤Upper Limit of Normal (ULN) (Part B)","Change from baseline in serum early morning A4 over time (Part C)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","chicago-illinois","boston-massachusetts","ann-arbor-michigan","minneapolis-minnesota","new-brunswick-new-jersey","new-york-new-york","philadelphia-pennsylvania","fort-worth-texas","charlottesville-virginia","buenos-aires-argentina","c-rdoba-argentina","westmead-australia","south-brisbane-australia","clayton-australia","nedlands-australia","edegem-belgium","brussels-belgium","ghent-belgium","leuven-belgium","porto-alegre-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","santiago-chile","talcahuano-chile","angers-france","le-kremlin-bic-tre-france","lille-france","marseille-france","paris-france","t-bingen-germany","cologne-germany","berlin-germany","naples-italy","genoa-italy","milan-italy","florence-italy","nijmegen-netherlands","wroclaw-poland","bialystok-poland","lodz-poland","szczecin-poland","riyadh-saudi-arabia","liverpool-united-kingdom","london-united-kingdom","manchester-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Atumelnant for Congenital Adrenal Hyperplasia","inPlainEnglish":"This study wants to measure the safety, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).","whoItsFor":["Ages 1 Year to 17 Years","Part A and B participants are eligible to be included in the study only if all of the following criteria apply:","Participants must have an elevated morning serum A4 level \\>ULN during Screening obtained prior to morning glucocorticoid (GC) administration","Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening","Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period","Biochemical euthyroidism as determined by the Investigator","Part C who can join require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age"],"whoShouldSkip":["Part A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:","Diagnosis of any form of CAH other than classic 21-OHD","Participants treated with other GCs within 30 days of Screening","Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone","Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting","Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening","History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ"],"whatHappens":"If you join, the listed intervention(s) are Atumelnant, or Placebo. The registry lists allocation as randomized. This study wants to measure the safety, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 153 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.415Z"},{"nctId":"NCT07161258","title":"A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS)","officialTitle":"An Open-label, Single-arm Study to Evaluate Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This open label, single arm study will evaluate the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\< 18 years.\n\nThis study consists of a Dose Exploration Period and an Optional Extension Period. Eligible participants may choose to continue treatment with fenebrutinib in the optional extension period after completing the dose exploration period.","conditions":["Relapsing Multiple Sclerosis"],"keywords":["Pediatric multiple sclerosis","Pediatric MS","Children MS","Children multiple sclerosis","Adolescent multiple sclerosis","Pediatric fenebrutinib"],"interventions":[{"type":"DRUG","name":"Fenebrutinib"}],"enrollment":12,"startDate":"2025-10-06","completionDate":"2027-06-08","sex":"ALL","minAge":"10 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* A diagnosis of RMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, and the revised 2017 McDonald Criteria and one or more of the following: at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 month\n* Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive\n* Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases\n\nExclusion Criteria:\n\n* A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)\n* Co-morbid Conditions:\n* Potentially confounding neurological, somatic, or metabolic disorders\n* Current clinically significant psychiatric or medical illness\n* History of cancer, transplants, or bleeding disorders\n* Inability to complete an MRI scan or get gadolinium\n* Abnormal liver function tests or blood counts\n* Sensitivity or intolerance to any ingredient (including excipients) of fenebrutinib tablets\n* Active, recurrent, or chronic infections\n* Recent or anticipated use of prohibited medications/treatments:\n* Certain disease-modifying therapy (DMT) and other immunosuppressants\n* Drugs interacting with fenebrutinib (Cytochrome P450 3A4 \\[CYP3A4\\] inhibitors)\n* Any other investigational therapy, anticoagulants, certain vaccines\n* A score of 4 or 5 on the \"last 6 months\" section of the screening SI section or \"yes\" on any item of the \"last 6 months\" Suicidal Behavior (SB) section of the C-SSRS or a positive answer on Question 9 of the Patient Health Questionnaire-9 Modified for Adolecents (PHQ-A) or significant risk of suicide, in the investigator's judgment","locations":[{"facility":"INECO Neurociencias Orono","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio del Sur S.A.","city":"San Miguel de Tucumán","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"L2IP ?Instituto de Pesquisas Clínicas Ltda.","city":"Brasília","state":"Federal District","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Neurologia de Curitiba - Hospital Ecoville","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisas Clinicas - CPCLIN","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinstile S.A de C.V.","city":"Mexico City","state":"Mexico CITY (federal District)","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurociencias Estudios Clinicos S.C.","city":"Culiacán","state":"Sinaloa","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny w Poznaniu","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instytut \"Pomnik - Centrum Zdrowia Dziecka\"","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Clnico Acadmico - Braga, Associao (2CA-Braga)","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade Local de Saude de Coimbra E P E","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de La Princesa","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"UH of State NPC Danulo Halytsky NMU in Lviv CID, Clinic of Neurology and Neurosurgery","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CN45847 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S.)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Plasma Concentration of Fenebrutinib","Total Number of New T1 Gadolinium (Gd)-enhancing Lesions on Brain Observed Through Magnetic Resonance Imaging (MRI) Scans"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["rosario-argentina","san-miguel-de-tucum-n-argentina","bras-lia-brazil","curitiba-brazil","porto-alegre-brazil","s-o-paulo-brazil","mexico-city-mexico","culiac-n-mexico","gdansk-poland","poznan-poland","warsaw-poland","braga-portugal","coimbra-portugal","madrid-spain","seville-spain","lviv-ukraine"],"enrichment":{"headline":"Phase 2: testing Fenebrutinib for Relapsing Multiple Sclerosis","inPlainEnglish":"This open label, single arm study will measure the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\< 18 years. This study consists of a Dose Exploration Period and an Optional Extension Period.","whoItsFor":["Ages 10 Years to 17 Years","Expanded Disability Status Scale (EDSS) at screening from 0 to 5.5 points, inclusive","Children and adolescents must have received all childhood vaccinations as per local/national recommendations for childhood vaccination against infectious diseases"],"whoShouldSkip":["A diagnosis of primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS)","Co-morbid Conditions:","Potentially confounding neurological, somatic, or metabolic disorders","Current clinically significant psychiatric or medical illness","History of cancer, transplants, or bleeding disorders","Inability to complete an MRI scan or get gadolinium","Abnormal liver function tests or blood counts"],"whatHappens":"If you join, the listed intervention(s) are Fenebrutinib. The registry lists allocation as na. This open label, single arm study will measure the PK and PD effects of fenebrutinib in children and adolescents with RMS aged between 10 and \\< 18 years.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 12 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.970Z"},{"nctId":"NCT07163416","title":"(Italian Migraine Registry, I-GRAINE-NEW)","officialTitle":"Project for the Construction of the Italian Migraine Registry I-GRAINE-New","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS San Raffaele Roma","sponsorClass":"OTHER","summary":"Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic \"evolutionary\" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments. When patients are admitted to the center is therefore the time when their history in terms of disease evolution and healthcare costs is most effectively collected, but also when it is assumed that the treatment strategy offered to the patient will have a greater impact.\n\nFor this reason, it was decided to conduct a large-scale retrospective and prospective observational study in order to draw a detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.\n\nDesign A multicenter, observational, retrospective and prospective cohort study, aimed at obtaining a more detailed picture of the situation of patients not followed by a specialized center and of the natural history of the disease once the pathway at the specialized center has started.6,000 of the incident patients (defined as those who had their first visit during the 6 months preceding enrollment in the registry), will be invited to take part in a follow-up and expanded data collection study.\n\nPatients will be consecutively enrolled by specialists at each individual site.. Eligible patients who agree to take part in the study by signing an informed consent form will be assessed clinically and through a direct interview with a structured questionnaire organized in several ad hoc sections.\n\nObjectives: The aim of the study is:\n\nanalyze episodic and chronic migraine in Italy from an epidemiological point of view, especially in terms of prevalence of the two forms of migraine and their endophenotypes in different population subgroups; 2. characterize the demographic distribution and clinical characteristics of patients (including the definition of endophenotypes); 3. measure the influence of the disease on the patient's daily activity, in terms of disability (assessed using the validated MIDAS and HIT-6 scales); 4. study the clinical and care pathway (patient journey) and identify the preferred care pathways based on the characteristics of the patients and the migraine subtype; 5. evaluate the prescribed pharmacological treatments, medical visits and diagnostic procedures performed (ascertaining the degree of adherence to current guidelines); 6. analyze the use of health resources by migraine patients, with particular attention to their impact on the SNS.\n\nVisits and Treatments:\n\nBaseline Visit: Patients enrolled in the study will undergo a thorough clinical and neurological examination.\n\nFollow-up Visits: Clinical data will continue to be collected over time, at each scheduled clinic visit based on the needs of clinical practice.\n\nStudy Population: Adult patients of both sexes with episodic or chronic migraine who have recently attended a specialized migraine center in the I-GRAINE-NEW registry.\n\nEstimated Study Duration: The duration of each patient's participation in the study is 24 months from the date of the initial visit to the participating migraine site","conditions":["Migraine Disorders"],"keywords":["Migraine,Register,Italy"],"interventions":[],"enrollment":2030,"startDate":"2021-04-19","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult Patients(Age ≥ 18 years) of both sexes\n* Diagnosis confirmed of episodic migraine ( \\<15 days/month ) with or without aura or chronic migraine (\\>15days/month) ,with or without headeche due to overuse of analgesics;\n* Provision of signed and dated the Informed Consent Form before the inclusion in the study\n\nExclusion Criteria:\n\n* Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain","locations":[{"facility":"Head, Irccs San Raffaele Roma S.r.l. - Unità per la cura e la ricerca su cefalee e dolore - Dipartimento di Neurologia, Via di Val di Cannuta 250, 00166 Roma (RM) - Italy","city":"Roma","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Piero Barbanti, MD","phone":"+390652254027","email":"piero.barbanti@sanraffaele.it"}],"primaryOutcomes":["Better definition of the dimensions of the migraine phenomenon in Italian headache centers","Information on the patient's level of awareness and knowledge of the migraine problem"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["roma-italy"],"enrichment":{"headline":"(Italian Migraine Registry, I-GRAINE-NEW)","inPlainEnglish":"Rationale Understanding the mechanisms and evolution of migraine is hampered by its nature as a chronic \"evolutionary\" condition. Patients often come to migraine centers after years of disabling disease, non-specific diagnoses and ineffective treatments.","whoItsFor":["Ages 18 Years to any","Adult Patients(Age ≥ 18 years) of both sexes","Diagnosis confirmed of episodic migraine ( \\<15 days/month ) with or without aura or chronic migraine (\\>15days/month) ,with or without headeche due to overuse of analgesics;"],"whoShouldSkip":["Patients affected by other forms of primary or secondary headaches or in whom the diagnosis is not certain"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,030 people at Roma. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.302Z"},{"nctId":"NCT07165028","title":"A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)","officialTitle":"A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression.\n\nOnce the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.","conditions":["Metabolic Dysfunction-Associated Steatotic Liver Disease"],"keywords":["Nonalcoholic Steatohepatitis","NASH","Fatty Liver","Fatty Liver Disease","SLD","Metabolic Dysfunction-Associated Fatty Liver Disease","MAFLD","Non-alcoholic Fatty Liver Disease","NAFLD","Hepatic Steatosis","Liver Related Outcomes","GLP1","Incretin","Non-Invasive Test"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Retatrutide"},{"type":"DRUG","name":"Placebo"}],"enrollment":4500,"startDate":"2025-10-15","completionDate":"2030-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have liver fat content ≥8%\n* Have ELF score of ≥9 and ≤10.8 at screening\n* Have VCTE LSM ≥10 kilopascal (kPa) and \\<20 kPa at screening\n\nExclusion Criteria:\n\n* Have any other type of liver disease other than MASLD\n* Have a body mass index (BMI) \\<25 kilogram per square meter (kg/m2)\n* Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)\n* Have lost more than 11 pounds within the 3 months prior to screening\n* Have a hemoglobin A1c (HbA1c) greater than 10%\n* Have type 1 diabetes","locations":[{"facility":"MFA Clinical Research","city":"Tuscaloosa","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II dba Arizona Clinical Trials - Chandler","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Research Institute","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II dba Arizona Liver Health - Peoria","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research-Sun City","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II dba Arizona Clinical Trials - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Gastroenterology - North Little Rock","city":"North Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Fernando Valley Health Institute","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research - 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3: testing Tirzepatide for Metabolic Dysfunction-Associated Steatotic Liver Disease","inPlainEnglish":"The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO.","whoItsFor":["Ages 18 Years to any","Have liver fat content ≥8%","Have ELF score of ≥9 and ≤10.8 at screening","Have VCTE LSM ≥10 kilopascal (kPa) and \\<20 kPa at screening"],"whoShouldSkip":["Have any other type of liver disease other than MASLD","Have a body mass index (body-mass index (BMI)) \\<25 kilogram per square meter (kg/m2)","Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)","Have lost more than 11 pounds within the 3 months prior to screening","Have a hemoglobin A1c (HbA1c) greater than 10%","Have type 1 diabetes"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, Retatrutide, or Placebo. The registry lists allocation as randomized. The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 4,500 people at 562 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.162Z"},{"nctId":"NCT07166094","title":"Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer","officialTitle":"A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Genmab","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.\n\nThe study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.\n\nAll participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).","conditions":["Endometrial Cancer","Recurrent or Progressive Endometrial Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rina-S"},{"type":"DRUG","name":"IC"}],"enrollment":660,"startDate":"2025-11-28","completionDate":"2029-08","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n* Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.\n* Participants must have received at least 1, but not more than 3, prior lines of therapy:\n\n  * Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination\n  * If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.\n\n    * Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.\n  * Prior induction plus maintenance is considered 1 line of therapy\n  * Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.\n  * Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)\n* Participants must have progressed radiographically on or after their most recent line of therapy\n\nKey Exclusion Criteria\n\n* Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n* Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).\n* Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.\n* Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. 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Málaga - Materno-Inf.","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HU Virgen del Rocío","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HU Virgen de Valme","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Genmab Trial Information","phone":"+4570202728","email":"clinicaltrials@genmab.com"}],"primaryOutcomes":["Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)","Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":[],"locationSlugs":["mobile-alabama","phoenix-arizona","irvine-california","san-francisco-california","danbury-connecticut","hartford-connecticut","norwalk-connecticut","washington-d-c-district-of-columbia","sarasota-florida","st-petersburg-florida","tampa-florida","atlanta-georgia","decatur-georgia","evanston-illinois","baton-rouge-louisiana","new-orleans-louisiana","shreveport-louisiana","baltimore-maryland","westminster-maryland","worcester-massachusetts","grand-rapids-michigan","coon-rapids-minnesota","edina-minnesota","maple-grove-minnesota","maplewood-minnesota","minneapolis-minnesota","woodbury-minnesota","st-louis-missouri","morristown-new-jersey","summit-new-jersey","teaneck-new-jersey","new-york-new-york","charlotte-north-carolina","concord-north-carolina","durham-north-carolina","gastonia-north-carolina","winston-salem-north-carolina","cincinnati-ohio","eugene-oregon","happy-valley-oregon","portland-oregon","tigard-oregon","arlington-texas","austin-texas","bedford-texas","dallas-texas","fort-worth-texas","harlingen-texas","mcallen-texas","san-antonio-texas","waco-texas","weslaco-texas","charlottesville-virginia","vancouver-washington","heidelberg-australia","campbelltown-australia","camperdown-australia","gosford-australia","kingswood-australia","waratah-australia","joondalup-australia","edegem-belgium","brussels-belgium","leuven-belgium","gilly-belgium","sint-niklaas-belgium","namur-belgium","rio-de-janeiro-brazil","porto-alegre-brazil","s-o-paulo-brazil","calgary-canada","vancouver-canada","montreal-canada","aalborg-denmark","helsinki-finland","oulu-finland","kuopio-finland","tampere-finland","clermont-ferrand-france","grenoble-france","strasbourg-france","dijon-france","brest-france","bordeaux-france","orl-ans-france","reims-france","nancy-france","montpellier-france","angers-france","bayonne-france","suresnes-france","hamburg-germany","wiesbaden-germany","bonn-germany","lemgo-germany","berlin-germany","p-trai-greece","athens-greece","haifa-israel","holon-israel","jerusalem-israel","nahariya-israel","ashdod-israel","bologna-italy","catania-italy","meldola-italy","monza-italy","milan-italy","prato-italy","reggio-emilia-italy","chiba-japan","ta-japan","shiwa-gun-japan","sagamihara-shi-japan","yokohama-japan","tsu-japan","sendai-japan","osaka-japan","nagaizumi-cho-japan","tokyo-japan","fukuoka-japan","fukushima-japan","hy-go-japan","niigata-japan","saitama-japan","sapporo-japan","takatsuki-japan","yamagata-japan","kaunas-lithuania","vilnius-lithuania","oslo-norway","bergen-norway","lublin-poland","siedlce-poland","bialystok-poland","szczecin-poland","kielce-poland","lodz-poland","san-juan-puerto-rico","singapore-singapore","palma-de-mallorca-spain","barcelona-spain","girona-spain","a-coru-a-spain","madrid-spain","m-laga-spain","pamplona-spain","valencia-spain","zaragoza-spain","seville-spain"],"enrichment":{"headline":"Phase 3: testing Rina-S for Endometrial Cancer","inPlainEnglish":"This study wants to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.","whoItsFor":["Ages 18 Years to any","Women only","Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy","Participants must have received at least 1, but not more than 3, prior lines of therapy:","Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination","Prior induction plus maintenance is considered 1 line of therapy","Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy","Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)","Participants must have progressed radiographically on or after their most recent line of therapy"],"whoShouldSkip":["Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor","Note: Other protocol-defined Inclusion and"],"whatHappens":"If you join, the listed intervention(s) are Rina-S, or IC. The registry lists allocation as randomized. This study wants to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 660 people at 176 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.702Z"},{"nctId":"NCT07166315","title":"Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor","officialTitle":"Clinical Characteristics, Treatment Patterns and Outcomes in Patients With axSpA and PsA Following Initiation of Bimekizumab, Risankizumab, Guselkumab, Upadacitinib or a TNF Inhibitor","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Adelphi Real World","sponsorClass":"INDUSTRY","summary":"This observational study will target patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) who have started treatment with bimekizumab, upadacitinib, risankizumab, guselkumab, or a tumour necrosis factor-alpha inhibitor (e.g., adalimumab or etanercept) at NHS hospitals in the United Kingdom. Information from patients' medical records will be collected, and patients will complete surveys about their experiences with their treatment. The study will look at treatment effectiveness from both healthcare professionals' and patients' points of view.","conditions":["Axial Spondylarthritis (axSpA)","Psoriatic Arthritis (PsA)"],"keywords":[],"interventions":[{"type":"OTHER","name":"observational study"}],"enrollment":700,"startDate":"2025-07-07","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant has a clinical diagnosis of axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA).\n* Participant has been prescribed advanced therapy within one month prior to enrolment in the study, to treat their axSpA or PsA.\n* Participant is aged 18 years or older at enrolment.\n\nExclusion Criteria:\n\n-Participation in a clinical trial at enrolment.","locations":[{"facility":"Royal National Hospital for Rheumatic Diseases","city":"Bath","state":"Somerset","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"SpA Extend Team","phone":"+441625 577 829","email":"arwspaextend@adelphigroup.com"}],"primaryOutcomes":["Number of participants that have achieved Low Disease Activity (LDA) at 12 months.","Number of participants that have achieved Minimal Disease Activity (MDA) at 12 months.","Change from baseline in PROM scores at 12 months."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["adalimumab","risankizumab"],"locationSlugs":["bath-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: observational study for Axial Spondylarthritis (axSpA)","inPlainEnglish":"This watch-and-measure (no experimental treatment required) study will target patients with axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) who have started treatment with bimekizumab, upadacitinib, risankizumab, guselkumab, or a tumour necrosis factor-alpha inhibitor (e.g., adalimumab or etanercept) at NHS hospitals in the United Kingdom. Information from patients' medical records will be collected, and patients will complete surveys about their experiences with their treatment.","whoItsFor":["Ages 18 Years to any","Participant has a clinical diagnosis of axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA)","Participant has been prescribed advanced therapy within one month prior to enrolment in the study, to treat their axSpA or PsA","Participant is aged 18 years or older at enrolment"],"whoShouldSkip":["Participation in a clinical trial at enrolment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 700 people at Bath. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.582Z"},{"nctId":"NCT07166601","title":"M0324 as Monotherapy and in Combination With Pembrolizumab or Chemotherapy in Participants With Selected Advanced Solid Tumors","officialTitle":"An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"EMD Serono Research & Development Institute, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).","conditions":["Advanced Solid Tumor"],"keywords":["Bispecific CD40 agonistic antibody","Mucin-1 (MUC-1)","pembrolizumab","mFOLFIRINOX","pancreatic ductal adenocarcinoma (PDAC)","non-small cell lung cancer (NSCLC)"],"interventions":[{"type":"BIOLOGICAL","name":"M0324"},{"type":"BIOLOGICAL","name":"M0324"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"DRUG","name":"mFOLFIRINOX"}],"enrollment":77,"startDate":"2025-10-10","completionDate":"2029-02-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPart 1- M0324 Monotherapy:\n\n• Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator\n\nPart 2- M0324 Combination with Pembrolizumab:\n\n• Participants with certain advanced/metastatic tumor types known to overexpress MUC-1 and the participants in the combination treatment involving M0324 and pembrolizumab must be intolerant or refractory to standard therapy and no other further standard therapy should be judged appropriate by the Investigator. In addition, the participants must have had prior treatment with immune checkpoint inhibitor(s) (ICIs) and must have experienced documented disease progression on or after ICIs.\n\nPart 3- M0324 Combination with mFOLFIRINOX:\n\n* Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted\n* Other protocol defined inclusion criteria could apply.\n\nExclusion Criteria:\n\n* Has a history of chronic diarrhea greater than or equal to (\\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction\n* Participant has a history of malignancy within 3 years before the date of enrollment\n* Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \\[New York Heart Association (NYHA) \\>= II\\] or a coronary revascularization procedure within 180 days of study entry\n* Life expectancy of less than 3 months\n* Other protocol defined exclusion criteria could apply.","locations":[{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US Medical Information","phone":"888-275-7376","email":"eMediUSA@emdserono.com"},{"name":"Communication Center","phone":"+49 6151 72 5200","email":"service@emdgroup.com"}],"primaryOutcomes":["Parts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)","Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)","Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["new-haven-connecticut","new-york-new-york","san-antonio-texas","toronto-canada","ch-ku-japan"],"enrichment":{"headline":"Phase 1: testing M0324 for Advanced Solid Tumor","inPlainEnglish":"The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of how well it works, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a this drug alone(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).","whoItsFor":["Ages 18 Years to any","Part 1- M0324 this drug alone:","Participants with certain advanced/metastatic solid tumor types known to overexpress MUC-1 and who are intolerant or refractory to standard therapy or for which no standard therapy is judged appropriate by the Investigator","Part 2- M0324 Combination with Pembrolizumab:","Part 3- M0324 Combination with mFOLFIRINOX:","Participants with previously untreated metastatic pancreatic ductal adenocarcinoma, who are judged by Investigator as eligible for treatment with mFOLFIRINOX. Participants with prior Whipple surgery and/or adjuvant chemotherapy are not permitted","Other protocol defined who can join could apply"],"whoShouldSkip":["Has a history of chronic diarrhea greater than or equal to (\\>=) Grade 2, inflammatory disease of the colon or rectum, or unresolved partial or complete intestinal obstruction","Participant has a history of malignancy within 3 years before the date of enrollment","Uncontrolled or poorly controlled arterial hypertension, uncontrolled cardiac arrhythmia, unstable angina, myocardial infarction, congestive heart failure \\[New York Heart Association (NYHA) \\>= II\\] or a coronary revascularization procedure within 180 days of study entry","Life expectancy of less than 3 months","Other protocol defined"],"whatHappens":"If you join, the listed intervention(s) are M0324, M0324, or Pembrolizumab. The registry lists allocation as randomized. The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of how well it works, pharmacokinetics (PK), and pharmacodynamics (PD).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 77 people at 5 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.936Z"},{"nctId":"NCT07169136","title":"Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)","officialTitle":"Effects of Glucagon-like Peptide-1 (GLP-1) Agonist in Neuro-reproductive Function in Obese Adolescent Females With Polycystic Ovary Syndrome (PCOS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Nemours Children's Clinic","sponsorClass":"OTHER","summary":"The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism. Gonadotropin-releasing hormone (GnRH) and gonadotropins, LH and FSH, are released in a pulsatile manner for appropriate sex steroids production and gonadal function. Proper pulsatility in the GnRH system is disrupted by a significant change in energy balance such as in obesity. Polycystic Ovary Syndrome (PCOS) is the most common neuroendocrine dysfunction in women of reproductive age. Glucagon-like peptide-1 (GL-1), a peptide hormone secreted by the intestinal enteroendocrine L-cells following glucose and fat intake, stimulates insulin release by the pancreas in response to glucose, decreases gastric emptying and inhibits glucagon secretion. GLP-1 receptors are present in the hypothalamic nuclei and pituitary gland; and it is thought that GLP-1 may directly stimulate GnRH secretion and partially regulate reproduction. In animal studies, GLP-1 was found to stimulate GnRH secretion, to regulate kisspeptin (Kiss-1) mRNA and GnRH mRAN expression. GLP-1 receptor agonists are FDA-approved to treat adults and adolescents with obesity. Although the impact of GLP-1 receptor agonists in reproductive health has been investigated in preclinical trials, and in men with obesity and functional hypogonadism, no studies to date have investigated the impact of GLP-1 receptor agonists in female neuroendocrine function, particularly in youth. The goal of this proposal is to gather critical preliminary data to investigate, in a group of obese adolescent females with PCOS, the impact of GLP-1 agonist administration in addition to lifestyle modifications on the neuroendocrine rhythms - LH frequency and amplitude (principal); body composition, adiposity; and carbohydrate metabolism and insulin sensitivity. To accomplish these aims, we will recruit a cohort of up to 20 adolescents ages 12-18 years, at least 2 years post-menarche, with obesity, PCOS, by NIH criteria, without carbohydrate intolerance and in otherwise good health. Research volunteers will be advised on lifestyle modifications of diet and exercise as per routine, and a GLP-1 agonist will be started according to the product's label as per FDA guidelines in children with obesity. Medication will be titrated to maximal therapeutic dose, as per routine clinical practice. Participants will be treated for a total of 16 weeks. Neuroendocrine rhythms pre- and post-treatment will be compared.","conditions":["Polycystic Ovarian Syndrome in Adolescent Females","Obesity (Disorder)"],"keywords":["PCOS","Obesity","Adolescent Female","irregular menstrual cycles"],"interventions":[{"type":"DRUG","name":"GLP-1 Receptor Agonists"}],"enrollment":20,"startDate":"2025-09-11","completionDate":"2026-12","sex":"FEMALE","minAge":"12 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles \\<21 or \\>35 days) and hyperandrogenism (testosterone level or free androgen index (FAI) \\> refence range for tanner stage) and in good overall health\n* Obesity (equal to or more than the 95th percentile)\n* Females ages 12 to 18 years, at least 2 years post-menarche\n* Participants has persistent symptoms of PCOS and obesity despite lifestyle modifications for at least 4 months.\n\nExclusion Criteria:\n\n* Has abnormal thyroid function tests at Screening.\n* Diabetes mellitus\n* Has non-classic congenital adrenal hyperplasia.\n* Has hyperprolactinemia.\n* Has a known history or family history of medullary thyroid carcinoma or MEN2 and history of pancreatitis\n* Participants receiving prior treatment with GLP-1 agonists, oral contraception pills or progesterone for at least 6 weeks prior to Screening.\n* Is currently pregnant or has been pregnant.","locations":[{"facility":"Nemours Children's Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Camila Pereira-Eshraghi, MD. MS.","phone":"1 + 904-408-7895","email":"camila.pereira-eshraghi@nemours.org"}],"primaryOutcomes":["Change in LH pulse frequency after 4 months of GLP-1 agonist use.","Change in average levels of LH and FSH after 4 months of GLP-1 agonist use.","Change in average levels of Total testosterone and Estradiol after 4 months of GLP-1 agonist use.","Change in average levels of progesterone after 4 months of GLP-1 agonist use.","Change in LH amplitude."],"hasResults":false,"conditionSlugs":["als","obesity","pcos"],"drugSlugs":[],"locationSlugs":["jacksonville-florida"],"enrichment":{"headline":"Not a traditional drug phase: testing GLP-1 Receptor Agonists for Polycystic Ovarian Syndrome in Adolescent Females","inPlainEnglish":"The prevalence of childhood obesity in the United States has more than tripled in the past four decades affecting one in every five adolescent girls and is disproportionally higher among racial and/or ethnic minorities. Normal puberty onset and progression is dependent on normal hypothalamic-pituitary-gonadal (HPG) axis which is affected by whole body metabolism.","whoItsFor":["Ages 12 Years to 18 Years","Women only","Diagnosed with PCOS, by NIH criteria: oligomenorrhea (menstrual cycles \\<21 or \\>35 days) and hyperandrogenism (testosterone level or free androgen index (FAI) \\> refence range for tanner stage) and in good overall health","Obesity (equal to or more than the 95th percentile)","Females ages 12 to 18 years, at least 2 years post-menarche","Participants has persistent symptoms of PCOS and obesity despite lifestyle modifications for at least 4 months"],"whoShouldSkip":["Has abnormal thyroid function tests at Screening","Has non-classic congenital adrenal hyperplasia","Has hyperprolactinemia","Has a known history or family history of medullary thyroid carcinoma or MEN2 and history of pancreatitis","Participants receiving prior treatment with GLP-1 agonists, oral contraception pills or progesterone for at least 6 weeks prior to Screening","Is currently pregnant or has been pregnant"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20 people at Jacksonville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.790Z"},{"nctId":"NCT07169630","title":"PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)","officialTitle":"PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer s Disease (AD) or Mild Cognitive Impairment (MCI)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nAbout 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias. The number of people with these disorders will likely increase as the population ages and life span increases. Inflammation is thought to play a role in AD and MCI. Researchers want to know if an enzyme called PDE4B increases inflammation in people with AD or MCI.\n\nObjective:\n\nTo test whether medical imaging using a new radiotracer (\\[18F\\]PF-06445974) can measure PDE4B in the brains of people with AD or MCI.\n\nEligibility:\n\nPeople aged 50 years and older with AD or MCI. Healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have up to 5 clinic visits with 3 imaging scans of the brain.\n\nThey will have be screened. They will have a physical exam with blood tests. This will include tests of their heart and nerve function, including memory.\n\nParticipants will have 2 positron emission tomography (PET) scans. One will use a standard radiotracer. The other will use the study radiotracer. They will receive each tracer through a tube attached to a needle inserted into a vein. During the scan with the study tracer, participants will have a second tube inserted into a vein in the wrist; this tube will be used to draw blood during the scan. Participants will lie on a bed that slides into a doughnut-shaped machine. These visits will take about 6 hours each.\n\nParticipants will have 1 magnetic resonance imaging (MRI) scan. They will lie on a bed that slides into a cylinder. This visit will take up to 2 hours....","conditions":["Alzheimer s Disease","Mild Cognitive Impairment","Healthy"],"keywords":["18F-PF-06445974","PET Imaging"],"interventions":[{"type":"DRUG","name":"18F-PF974"},{"type":"DRUG","name":"18F-florbetaben"}],"enrollment":90,"startDate":"2026-11-15","completionDate":"2029-04-11","sex":"ALL","minAge":"50 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nParticipants will be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI.\n\nAD and MCI Study Groups:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Be able (or have their Legally Authorized Representative (LAR) be able) to understand the study and be willing to sign a written informed consent document.\n* Have been diagnosed by a neurologist or psychiatrist with MCI or AD.\n* Be in good general health as evidenced by medical history and physical examination.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nHealthy Volunteers:\n\nParticipants must meet all the following criteria:\n\n* Aged 50 or older.\n* Able to provide informed consent.\n* Be in good general health, as evidenced by medical history and physical examination, and have no cognitive impairment.\n* Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists.\n* Agree to adhere to the lifestyle considerations.\n\nEXCLUSION CRITERIA:\n\nBoth the study groups will be excluded if they meet any of the following criteria:\n\n* Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen).\n* Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month.\n* Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities.\n* Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy).\n* Are unable to travel to the NIH.\n* Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits.\n* Have an inability to lie flat and/or lie still on the camera bed for at least two hours, including claustrophobia, overweight greater than the maximum for the scanner, and uncontrollable behavioral symptoms, which will be screened by an interview with the volunteer and/or caregiver during the screening visit.\n* Participants must not have substance use disorder or alcohol use disorder.\n* Participants should not be under treatment or previously treated with an amyloid antibody such as lecanemab.\n* Are unable to have an MRI scan (e.g., because of pacemakers or other implanted electrical devices, brain stimulators, dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pumps, shrapnel fragments, or metal fragments in the eye).\n* Pregnancy or breast feeding.\n* HIV infection.\n* Non-English speaking participants.\n\nExclusion of Children:\n\nInclusion of children is not appropriate, because this protocol has more than minimal risk from radiation exposure without the possibility of direct benefit.\n\nExclusion of Pregnant or Breastfeeding Women:\n\nPregnant women will be excluded because this protocol involves exposure to ionizing radiation. Lactating women will be excluded because radioisotopes may be excreted in milk. We will not require contraception for this protocol to allow participants autonomy in medical decision-making. However, while we will not require contraception for woman of childbearing potential, we will perform a pregnancy test at screening and prior to all procedures to ensure participants are not pregnant\n\nExclusion of Participants who are HIV Positive:\n\nPersons with HIV infection are excluded because HIV infection itself may change cAMP signaling.\n\nExclusion of Non-English-Speaking Participants:\n\nNon-English-speaking participants will be excluded from participation in this study because neuropsychological testing is required by this protocol. This testing, which is critical for interpreting study results, has not been validated in other languages or when using a translator.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tara N Turon, C.R.N.P.","phone":"(301) 827-6599","email":"tara.turon@nih.gov"},{"name":"Paul A Parcon, M.D.","phone":"(301) 496-5447","email":"paul.parcon@nih.gov"}],"primaryOutcomes":["To determine whether PDE4B radioligand binding is increased in medial temporal lobe of participants with AD or MCI (both A <= positive) compared to age-and sex matched HVs (who are A <= negative."],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing 18F-PF974 for Alzheimer s Disease","inPlainEnglish":"Background: About 5 million adults in the United States have age-related brain disorders. These include Alzheimer disease (AD), mild cognitive impairment (MCI), and other dementias.","whoItsFor":["Ages 50 Years to 100 Years","you would be referred by a physician with the suspected diagnosis of AD or MCI. However, the PI of this protocol will provide the final diagnosis. For this reason, this protocol will have just one consent form for participants suspected of having either AD or MCI","AD and MCI Study Groups:","Participants must meet all the following criteria:","Have been diagnosed by a neurologist or psychiatrist with MCI or AD","Be in good general health as evidenced by medical history and physical examination","Have had their radial artery pulse checked for the presence of adequate ulnar collateral flow and the absence of any metal or foreign objects in both wrists","Agree to adhere to the lifestyle considerations"],"whoShouldSkip":["Both the study groups will be excluded if they meet any of the following criteria:","Clinically significant abnormalities on EKG or laboratory testing. This includes CBC and acute care panel (Na, K, Cl, CO2, creatinine, glucose, urea nitrogen)","Participants should not have taken non-steroidal anti-inflammatory drugs (NSAIDs) for two weeks prior to the PET scan. Aspirin, corticosteroids (with the exception of skin products), or immunosuppressants (e.g., methotrexate) must not have been taken in the prior month","Have other major neurological or medical diseases that may cause cognitive dysfunction, such as structural brain diseases, metabolic diseases, paraneoplastic syndromes, infectious diseases, or other significant neurological abnormalities","Have an unstable medical condition that, in the opinion of the investigators, makes participation unsafe (e.g., an active infection or untreated malignancy)","Are unable to travel to the NIH","Have recent exposure to radiation related to research (e.g., PET from other research) that, when combined with this study, would be above the allowable limits"],"whatHappens":"If you join, the listed intervention(s) are 18F-PF974, or 18F-florbetaben. The registry lists allocation as na. Background: About 5 million adults in the United States have age-related brain disorders.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.319Z"},{"nctId":"NCT07172919","title":"A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation","officialTitle":"A Rollover Study of Sotorasib With or Without Panitumumab for the Treatment of Cancer Subjects With KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Amgen","sponsorClass":"INDUSTRY","summary":"The primary objective of the study is to evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.","conditions":["Advanced Solid Tumors"],"keywords":["Advanced solid tumors","Sotorasib","Panitumumab","AMG 510"],"interventions":[{"type":"DRUG","name":"Sotorasib"},{"type":"DRUG","name":"Panitumumab"}],"enrollment":14,"startDate":"2026-01-02","completionDate":"2028-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed informed consent.\n* Age ≥ 18 years.\n* Life expectancy of \\> 3 months, in the opinion of the investigator.\n* Ability to take oral medications and willing to record daily adherence to sotorasib through the use of a written diary.\n* Participant is currently receiving treatment with sotorasib alone or in combination therapy in an Amgen-sponsored trial that has met its endpoints or otherwise will be stopping (also referred to as parent study) and are continuing to receive clinical benefit in the opinion of the investigator.\n* For a participant on combination therapy in their parent study, treatment with other anti-cancer therapies is allowed provided it matches the parent study.\n* Eastern Cooperative Oncology Group Performance Status of ≤ 2.\n\nExclusion Criteria:\n\n* Participant had permanently discontinued from sotorasib study treatment in the parent study before the parent study's completion.\n* Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at the time of the termination of the parent study.\n* Local access to commercially available investigational product(s) at no cost to the participant as permitted by local/country regulation.\n* Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit to the participant in the opinion of the investigator.\n* Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.\n* Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to participant safety, in the opinion of the investigator.\n* Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional:\n\n  * 7 days after the last dose of sotorasib.\n  * 2 months after the last dose of panitumumab.\n* Female participants who are breastfeeding or who plan to breastfeed while on study through:\n\n  * 7 days after the last dose of sotorasib.\n  * 2 months after the last dose of panitumumab.\n* Female participants planning to become pregnant while on study through:\n\n  * 7 days after the last dose of sotorasib.\n  * 2 months after the last dose of panitumumab.\n* Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a highly sensitive urine or serum pregnancy test.\n* Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib.\n* Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib.\n* Male participants unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of sotorasib.","locations":[{"facility":"Florida Cancer Specialists - Fort Myers","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scientia Clinical Research Ltd","city":"Randwick","state":"New South Wales","country":"Australia","status":"TERMINATED","lat":null,"lon":null},{"facility":"Centre Leon Berard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelische Lungenklinik","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Dunant Hospital Center","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Theagenion Cancer Hospital","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Hokkaido Cancer Center","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"TERMINATED","lat":null,"lon":null},{"facility":"Universitaetsspital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amgen Call Center","phone":"866-572-6436","email":"medinfo@amgen.com"}],"primaryOutcomes":["Number of Participants with Treatment-Emergent Adverse Events (TEAEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["sotorasib"],"locationSlugs":["fort-myers-florida","houston-texas","randwick-australia","lyon-france","berlin-germany","athens-greece","thessaloniki-greece","roma-italy","sapporo-japan","basel-switzerland","taichung-taiwan"],"enrichment":{"headline":"Phase 2: testing Sotorasib for Advanced Solid Tumors","inPlainEnglish":"The primary objective of the study is to measure the whether it is safe and how hard side effects are to live with of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.","whoItsFor":["Ages 18 Years to any","Life expectancy of \\> 3 months, in the opinion of the investigator","Ability to take oral medications and willing to record daily adherence to sotorasib through the use of a written diary","For a participant on combination therapy in their parent study, treatment with other anti-cancer therapies is allowed provided it matches the parent study","Eastern Cooperative Oncology Group Performance Status of ≤ 2"],"whoShouldSkip":["Participant had permanently discontinued from sotorasib study treatment in the parent study before the parent study's completion","Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at the time of the termination of the parent study","Local access to commercially available investigational product(s) at no cost to the participant as permitted by local/country regulation","Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit to the participant in the opinion of the investigator","Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator","Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to participant safety, in the opinion of the investigator","Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional:"],"whatHappens":"If you join, the listed intervention(s) are Sotorasib, or Panitumumab. The registry lists allocation as randomized. The primary objective of the study is to measure the whether it is safe and how hard side effects are to live with of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 14 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.971Z"},{"nctId":"NCT07173803","title":"The Progressive Supranuclear Palsy Clinical Trial Platform","officialTitle":"The Progressive Supranuclear Palsy Clinical Trial Platform","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Adam Boxer","sponsorClass":"OTHER","summary":"The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of PSP.","conditions":["Progressive Supranuclear Palsy(PSP)"],"keywords":["PSP","Placebo-Controlled","Double-Blind","Master Protocol"],"interventions":[{"type":"BIOLOGICAL","name":"AADvac1"},{"type":"DRUG","name":"LM11A-31"}],"enrollment":440,"startDate":"2026-07-29","completionDate":"2030-09-28","sex":"ALL","minAge":"41 Years","maxAge":"86 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria.\n2. Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI).\n3. Mini-Mental State Examination (MMSE) score at screening of ≥25.\n4. Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support).\n5. Stable doses of permitted medications as described per protocol for 30 days prior to screening.\n6. Resides at home or in the community (assisted living is acceptable).\n7. As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures.\n\nExclusion Criteria:\n\n1. Females who are breastfeeding or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study.\n2. Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use a highly effective method of contraception for the duration of their participation in the study.\n3. Lacks good venous access such that multiple blood draws would be precluded.\n4. Weighs less than 40kg, or more than 136kg at screening.\n5. Blood transfusion within 4 weeks of screening.\n6. Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia.\n7. Screening MRI scan showing structural evidence of alternative pathology not consistent with PSP that could explain a substantial portion of the participant's symptoms as indicated by the central MRI read.\n8. Any unstable and/or clinically significant medical condition likely to hamper the evaluation of safety and/or efficacy of study drug (e.g., clinically significant reduction in serum B12 or folate levels, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular or cardiovascular conditions), as per the site PI's judgment.\n9. History of severe allergic reaction (e.g., anaphylaxis) including but not limited to: severe allergic reaction to previous vaccines, foods, and/or medications.\n10. Hospitalization within 30 days prior to screening or baseline.\n11. Infections or major surgical procedures within 3 months prior to screening, judged to be clinically significant by the site PI.\n12. Myocardial infarction within 1 year prior to baseline, unstable angina pectoris, symptomatic congestive heart failure.\n13. History of cancer within the past 5 years other than treated skin squamous cell carcinoma, basal cell carcinoma, and melanoma in-situ, localized prostate cancer not requiring treatment, or prostate or breast cancer, which have been fully removed and are considered cured.\n14. History or presence of immunological or inflammatory conditions, including neurological disorders, meningitis or meningoencephalitis.\n15. History or presence of epilepsy requiring ongoing use of antiepileptic medications. Antiepileptic medications are permitted for pain or psychiatric use per the protocol.\n16. DSM-5 criteria for drug or alcohol abuse or dependence currently met within the past 5 years.\n17. Clinically significant abnormal vital signs including sustained sitting blood pressure \\>160/100 mm Hg.\n18. Diabetes mellitus with hemoglobin A1c (HbA1c) levels of ≥8.0%.\n19. Known history of human immunodeficiency virus (HIV-1 or 2).\n20. Known history of acute/chronic hepatitis B or C unless treated curatively.","locations":[{"facility":"Banner Sun Health Research Institute","city":"Sun City","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rush University","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland School of Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albany Medical College","city":"Albany","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Butler Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Neurological Institute","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Washington, Memory and Brain Wellness Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"PSP Trial Platform Team","phone":"415-514-9420","email":"psptrialplatform@ucsf.edu"}],"primaryOutcomes":["Disease progression"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["sun-city-arizona","los-angeles-california","palo-alto-california","san-diego-california","san-francisco-california","aurora-colorado","new-haven-connecticut","chicago-illinois","indianapolis-indiana","baltimore-maryland","boston-massachusetts","albany-new-york","cincinnati-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","providence-rhode-island","houston-texas","richmond-virginia","seattle-washington"],"enrichment":{"headline":"Phase 2: testing AADvac1 for Progressive Supranuclear Palsy(PSP)","inPlainEnglish":"The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and how well it works of investigational products for the treatment of PSP.","whoItsFor":["Ages 41 Years to 86 Years","Clinical diagnosis of possible or probable PSP Richardson's Syndrome as defined by the 2017 Movement Disorder Society (MDS) criteria","Presence of PSP symptoms for ≤5 years at screening (based on the best judgment of the site PI)","Mini-Mental State Examination (MMSE) score at screening of ≥25","Able to walk at least 10 steps with minimal assistance (e.g., one arm for safety, but not postural support)","Stable doses of permitted medications as described per protocol for 30 days prior to screening","Resides at home or in the community (assisted living is acceptable)","As assessed by the site PI, participant is likely to be able to comply with the protocol for the duration of the study, and has adequate vision, hearing (hearing aid permitted), and literacy (English or Spanish) sufficient for compliance with the required testing procedures"],"whoShouldSkip":["Females who are breastfeeding or pregnant (as documented by a urine pregnancy test) during screening, or plan to become pregnant during the study","Females of childbearing potential who did not use a highly effective method of contraception within 28 days of screening and/or are not willing to use a highly effective method of contraception for the duration of their participation in the study","Lacks good venous access such that multiple blood draws would be precluded","Weighs less than 40kg, or more than 136kg at screening","Blood transfusion within 4 weeks of screening","Contraindications to MRI studies, including metal (ferromagnetic) implants, a cardiac pacemaker that is not compatible with MRI, and/or severe claustrophobia","Screening MRI scan showing structural evidence of alternative pathology not consistent with PSP that could explain a substantial portion of the participant's symptoms as indicated by the central MRI read"],"whatHappens":"If you join, the listed intervention(s) are AADvac1, or LM11A-31. The registry lists allocation as randomized. The Progressive Supranuclear Palsy Clinical Trial Platform (PTP) is a multi-center, multi-regimen clinical trial evaluating the safety and how well it works of investigational products for the treatment of PSP.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 440 people at 21 sites. 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Score"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","fullerton-california","la-jolla-california","los-angeles-california","palo-alto-california","pasadena-california","san-francisco-california","stanford-california","englewood-colorado","new-haven-connecticut","washington-d-c-district-of-columbia","atlantis-florida","boca-raton-florida","lady-lake-florida","maitland-florida","miami-florida","orlando-florida","tampa-florida","atlanta-georgia","honolulu-hawaii","chicago-illinois","kansas-city-kansas","boston-massachusetts","farmington-hills-michigan","st-louis-missouri","las-vegas-nevada","reno-nevada","paramus-new-jersey","albuquerque-new-mexico","amherst-new-york","commack-new-york","new-york-new-york","asheville-north-carolina","durham-north-carolina","canton-ohio","cleveland-ohio","tulsa-oklahoma","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","sioux-falls-south-dakota","memphis-tennessee","nashville-tennessee","dallas-texas","round-rock-texas","burlington-vermont","charlottesville-virginia","richmond-virginia","morgantown-west-virginia","kogarah-australia","westmead-australia","woolloongabba-australia","clayton-australia","parkville-australia","prahan-australia","nedlands-australia","graz-austria","innsbruck-austria","linz-austria","vienna-austria","salvador-brazil","bras-lia-brazil","belo-horizonte-brazil","curitiba-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","toronto-canada","montreal-canada","beijing-china","changchun-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","hangzhou-china","nanjing-china","shanghai-china","suzhou-china","tianjin-china","xian-china","xuzhou-china","aarhus-n-denmark","herning-denmark","k-benhavn-nv-denmark","marseille-france","bron-france","clermont-ferrand-france","cr-teil-france","la-tronche-france","lille-france","limoges-france","montpellier-france","nice-france","paris-france","toulouse-france","beelitz-germany","berlin-germany","bochum-germany","dresden-germany","d-sseldorf-germany","erlangen-germany","freiburg-im-breisgau-germany","hanover-germany","heidelberg-germany","homburg-germany","kassel-germany","munich-germany","m-nchen-germany","m-nster-germany","t-bingen-germany","w-rzburg-germany","naples-italy","salerno-italy","bologna-italy","cassino-italy","rome-italy","genoa-italy","brescia-italy","milan-italy","pisa-italy","padova-italy","mexico-city-mexico","bia-ystok-poland","bydgoszcz-poland","gda-sk-poland","katowice-poland","krakow-poland","lublin-poland","o-wi-cim-poland","rzesz-w-poland","warsaw-poland","braga-portugal","coimbra-portugal","funchal-portugal","guimar-es-portugal","lisbon-portugal","matosinhos-municipality-portugal","torres-vedras-portugal","seoul-south-korea","elche-spain","sant-cugat-del-vall-s-spain","donostia-san-sebastian-spain","a-coru-a-spain","alcorc-n-spain","pozuelo-de-alarc-n-spain","barcelona-spain","madrid-spain","m-laga-spain","seville-spain","changhua-county-taiwan","north-dist-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","dundee-united-kingdom","exeter-united-kingdom","london-united-kingdom","newcastle-united-kingdom","oxford-united-kingdom","plymouth-devon-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Prasinezumab for Parkinson's Disease","inPlainEnglish":"This study wants to measure the how well it works, safety, and pharmacokinetics (PK) of prasinezumab compared with dummy treatment (placebo) in participants with early-stage Parkinson's disease (PD) on stable symptomatic this drug alone with levodopa.","whoItsFor":["Ages 50 Years to 85 Years","Body weight within 40-110 kilograms (kg) (88-242 pounds \\[lbs\\]) and a body mass index within the range 18-34 kg/m2","Diagnosis of idiopathic PD based on Movement Disorder Society (MDS) criteria","Has received this drug alone treatment","An MDS-UPDRS Part IV score of 0 at screening and prior to randomization","Hoehn and Yahr (H\\&Y) Stage 1 or 2 off medication at screening and prior to randomization","Agreement to adhere to the contraception requirements"],"whoShouldSkip":["Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required","Medical history indicating a parkinsonian syndrome other than idiopathic PD","Diagnosis of a significant neurologic disease other than PD","Chronic uncontrolled hypertension"],"whatHappens":"If you join, the listed intervention(s) are Prasinezumab, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works, safety, and pharmacokinetics (PK) of prasinezumab compared with dummy treatment (placebo) in participants with early-stage Parkinson's disease (PD) on stable symptomatic this drug alone with levodopa.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 900 people at 192 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.668Z"},{"nctId":"NCT07174336","title":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","officialTitle":"A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.","conditions":["Breast Neoplasms","Neoplasm Metastasis"],"keywords":["STX-478","PI3K"],"interventions":[{"type":"DRUG","name":"LY4064809"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Ribociclib"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Anastrozole"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Exemestane"},{"type":"DRUG","name":"Fulvestrant"}],"enrollment":800,"startDate":"2025-12-22","completionDate":"2029-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials.\n* If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist.\n* If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist.\n* Have histologically or cytologically confirmed breast cancer, defined as individuals with\n\n  * locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and\n  * hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines\n\n    * HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally\n    * HER status: immunohistochemistry score of 1+ or score of 2+ with a negative Fluorescence In Situ Hybridization (FISH) based on local results as defined in the ASCO/CAP Guidelines\n* Have evidence of an activating PIK3CA mutation, detected in tumor or blood samples using an appropriate assay.\n* Have measurable disease or non-measurable, evaluable bone disease\n* Part 1:\n\n  * Received 0-2 prior systemic treatments for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Up to 1 of these prior systemic treatments may contain chemotherapy\n* Part 2:\n\n  * Received 0 prior systemic treatment for advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease.\n  * Individuals who are eligible are either\n\n    * Population 1 (P1): Endocrine sensitive\n\n      * newly diagnosed with advanced breast cancer (de novo)\n      * participants with a history of HR+, HER2- EBC and did not receive SOC adjuvant ET\n      * relapsed with documented evidence of progression greater than (\\>)12 months from completion of (neo)adjuvant ET ± cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor, or\n    * Population 2 (P2): Endocrine resistant\n\n      * relapsed with documented evidence of progression less than or equal to (≤)12 months of completing (neo)adjuvant ET ± CDK4/6 inhibitor.\n      * if a CDK4/6 inhibitor was included as part of neoadjuvant or adjuvant therapy, progression event must be \\>12 months since completion of CDK4/6 inhibitor portion of neoadjuvant or adjuvant therapy.\n\nExclusion Criteria:\n\n* Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \\[mmol/L\\]), or requiring insulin.\n* Have inflammatory or metaplastic breast cancer.\n* History of leptomeningeal disease or carcinomatous meningitis.\n* Have known and untreated or active central nervous system (CNS) metastases. Exception: Asymptomatic brain or spinal metastases if treated by surgery, surgery plus radiotherapy, or radiotherapy alone with no evidence of radiographic progression or hemorrhage within at least 28 days before randomization and no requirement for anticonvulsants or systemic corticosteroids for at least 28 days before randomization.\n* Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days.\n* Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \\[mg\\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment.\n* Have active bacterial or fungal infection that is not recovered at randomization.","locations":[{"facility":"Alaska Oncology and Hematology","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ironwood Cancer & Research Centers","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Joseph's Hospital and Medical Center","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Arizona - 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pan","shizuoka-japan","suita-japan","tsukuba-japan","yokohama-japan","singapore-singapore","cheonan-si-south-korea","deagu-south-korea","gangnam-gu-south-korea","gyeongsan-si-south-korea","incheon-south-korea","seoul-south-korea","badajoz-spain","barcelona-spain","c-ceres-spain","donostia-san-sebastian-spain","granada-spain","hospitalet-spain","ja-n-spain","las-palmas-de-gran-canaria-spain","lleida-spain","madrid-spain","m-laga-spain","palma-spain","salamanca-spain","san-crist-bal-de-la-laguna-spain","santiago-de-compostela-spain","seville-spain","valencia-spain","zaragoza-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","aydin-turkey-t-rkiye","edirne-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","mersin-turkey-t-rkiye","edinburgh-united-kingdom","huddersfield-united-kingdom","london-united-kingdom","manchester-united-kingdom","plymouth-united-kingdom","worcester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing LY4064809 for Breast Neoplasms","inPlainEnglish":"The purpose of the study is to assess the how well it works and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.","whoItsFor":["Ages 18 Years to any","Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials","If assigned female at birth, pre-/peri- and postmenopausal status is allowed. Those with pre- or peri-menopausal status at study entry must agree to use ovarian function suppression with any locally approved gonadotropin-releasing hormone (GnRH) agonist","If assigned male at birth with an estrogen receptor positive (ER+) breast cancer diagnosis, they must agree to use hormone suppression with a GnRH agonist","Have histologically or cytologically confirmed breast cancer, defined as individuals with","locally advanced breast cancer not amenable to curative therapy (for example, surgery) or metastatic disease, and","hormone receptors (HR)+/human epidermal growth factor receptor 2 (HER2)- or HR+/HER low defined by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Guidelines","HR status: Documented ER+ and/or progesterone receptor-positive (PR+) tumor according to ASCO/CAP Guidelines, defined as greater than or equal to (≥)1 percent (%) of tumor cells stained positive based on the most recent tumor biopsy and assessed locally"],"whoShouldSkip":["Have an established diagnosis of Type 1 diabetes mellitus or Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) ≥8%, fasting blood glucose (FBG) ≥140 milligrams per deciliter (mg/dL) (7.7 millimoles per liter \\[mmol/L\\]), or requiring insulin","Have inflammatory or metaplastic breast cancer","History of leptomeningeal disease or carcinomatous meningitis","Have received treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to randomization up to a maximum washout period of 28 days","Have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dose more than 10 milligrams \\[mg\\] daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization","Are pregnant, breastfeeding, or intend to become pregnant during the study or within 6 months of the last dose of study intervention and at least 2 years after the last dose of fulvestrant and/or CDK4/6 inhibitor after the final administration of study treatment","Have active bacterial or fungal infection that is not recovered at randomization"],"whatHappens":"If you join, the listed intervention(s) are LY4064809, Placebo, or Ribociclib. The registry lists allocation as randomized. The purpose of the study is to assess the how well it works and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 800 people at 362 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.712Z"},{"nctId":"NCT07174388","title":"An External Control Arm Study in Non-Small Cell Lung Cancer","officialTitle":"A Prospective Study to Generate Precision External Controls in Advanced or Metastatic Non Small Cell Lung Cancer Patients","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"N-Power Medicine","sponsorClass":"INDUSTRY","summary":"A study to create control arms using current and future information in patients with lung cancer.","conditions":["Non Small Cell Lung Cancer"],"keywords":["NSCLC","External Control Arm","Non-Interventional","N-Power Medicine","Registry","Prospective"],"interventions":[],"enrollment":650,"startDate":"2026-01-07","completionDate":"2029-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. \\> 18 years of age at the time of informed consent\n2. Pathologically confirmed locally advanced or metastatic NSCLC\n3. ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy.\n4. Life expectancy of more than 3 months\n5. Able to understand and sign informed consent\n6. Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)\n\n\\*see protocol for cohort specific inclusion criteria\\*\n\nExclusion Criteria:\n\n1. Actively on a clinical trial of an investigational agent\n2. Currently receiving active systemic therapy for another malignancy\n3. Eligible for treatment with curative intent\n\n\\*see protocol for cohort specific exclusion criteria\\*","locations":[{"facility":"Pacific Cancer Care","city":"Monterey","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bayhealth Medical Center, Kent Campus","city":"Dover","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bayhealth Medical Center- Sussex Campus","city":"Milford","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology and Hematology","city":"Barrington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology and Hematology","city":"Elk Grove","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology and Hematology","city":"Hoffman Estates","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Oncology and Hematology","city":"Rolling Meadows","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Mexico Oncology Hematology Consultants","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Cancer and Blood Specialists","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Main Line Health","city":"Wynnewood","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Consultants","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Assess Objective Response Rate (ORR) by cohort in patients with metastatic NSCLC treated in second or third line with NCCN recommended therapies"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["monterey-california","dover-delaware","milford-delaware","barrington-illinois","elk-grove-illinois","hoffman-estates-illinois","rolling-meadows-illinois","albuquerque-new-mexico","new-york-new-york","wynnewood-pennsylvania","houston-texas"],"enrichment":{"headline":"An External Control Arm Study in Non-Small Cell Lung Cancer","inPlainEnglish":"A study to create control arms using current and future information in patients with lung cancer.","whoItsFor":["Ages 18 Years to any","Pathologically confirmed locally advanced or metastatic NSCLC","ECOG Performance of less than or equal to 1 within 4 weeks prior to starting index therapy","Life expectancy of more than 3 months","Evidence of measurable disease (as assessed by the Investigator) on available imaging (e.g CT, MRI, PET)","\\*see protocol for cohort specific who can join\\*"],"whoShouldSkip":["Actively on a clinical trial of an investigational agent","Currently receiving active systemic therapy for another malignancy","Eligible for treatment with curative intent","\\*see protocol for cohort specific"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 650 people at 11 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.686Z"},{"nctId":"NCT07174687","title":"SGLT2 Inhibitors in Geographic Atrophy","officialTitle":"Efficacy of Dapagliflozin in the Progression of Geographic Atrophy Secondary to Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form. Geographic atrophy (GA) is an advanced stage of dry AMD characterized by progressive retinal cell degeneration. The primary objectives of the study are to assess the safety, tolerability, and evidence of activity of SGLT2 inhibitors in subjects with Geographic Atrophy associated with AMD.","conditions":["Retinal Degeneration","Retinal Diseases","Eye Diseases","Geographic Atrophy","Pathological Conditions, Anatomical"],"keywords":["Geographic Atrophy (GA)","Age-related Macular Degeneration","AMD","SGLT2","Dapagliflozin"],"interventions":[{"type":"DRUG","name":"Dapagliflozin"},{"type":"OTHER","name":"Matching Placebo"}],"enrollment":70,"startDate":"2025-12-02","completionDate":"2027-12","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n2. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n3. Participant is male or, if female, participant is surgically sterilized or amenorrheic for at least one year\n4. ≥50 years old\n5. Evidence of dry advanced AMD, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met\n\n   1. The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits\n   2. Total area of geographic atrophy must be between 2.5 mm2 and 17.5 mm2 (1 - 4 disc areas, respectively).\n   3. If the geographic atrophy consists of multiple lesions, at least one lesion must have an area of ≥1.25 mm² (equivalent to 0.5 disc areas).\n6. BCVA between 20/25 and 20/320\n7. Must be treatment-naïve for AMD in study eye, except for oral supplements\n\nExclusion Criteria\n\n1. Prior investigational drug use within 60 days\n2. Use of other SGLT2 inhibitors\n3. History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP \\< 90mmHg) at baseline\n4. Type I and Type II Diabetes Mellitus\n5. End stage renal disease or estimated glomerular filtration rate less than 25 mL/min/1.73 m2 per MDRD calculation\n6. History of heart failure\n7. History of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA\n8. Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures\n\n   1. Any prior intravitreal treatment for any indication in the study eye.\n   2. Prior intravitreal treatment (steroids, anti-VEGF) in the fellow eye is permitted if all injections occurred more than 6 months prior to screening, provided the participant has no active intravitreal treatment in either eye at screening or during the study period\n   3. Prior exposure to complement inhibitor therapy for retinal disease in either eye at any time remains exclusionary\n9. Any intraocular surgery or thermal laser within 3 months of date of randomization\n10. Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks\n11. Any prior thermal laser in the macular region, regardless of indication (self-report)\n12. Any evidence of choroidal neovascularization in study eye\n13. Enrollment in another interventional trial during the trial period","locations":[{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eve Adcock","phone":"314-286-2946","email":"adcockl@wustl.edu"}],"primaryOutcomes":["Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":["dapagliflozin"],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Phase 2: testing Dapagliflozin for Retinal Degeneration","inPlainEnglish":"AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form. Geographic atrophy (GA) is an advanced stage of dry AMD characterized by progressive retinal cell degeneration.","whoItsFor":["Ages 50 Years to any","Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures","Participant is male or, if female, participant is surgically sterilized or amenorrheic for at least one year","Evidence of dry advanced AMD, including non-foveal GA or small foveal-involving GA, provided visual acuity criteria are met","The geographic atrophy may involve the fovea, provided the best-corrected visual acuity remains within protocol limits","Total area of geographic atrophy must be between 2.5 mm2 and 17.5 mm2 (1 - 4 disc areas, respectively)","If the geographic atrophy consists of multiple lesions, at least one lesion must have an area of ≥1.25 mm² (equivalent to 0.5 disc areas)","BCVA between 20/25 and 20/320"],"whoShouldSkip":["Prior investigational drug use within 60 days","Use of other SGLT2 inhibitors","History of symptomatic hypotension or symptomatic hypotension (symptoms of hypotension + SBP \\< 90mmHg) at baseline","Type I and Type II Diabetes Mellitus","End stage renal disease or estimated glomerular filtration rate less than 25 mL/min/1.73 m2 per MDRD calculation","History of heart failure","History of a serious hypersensitivity reaction to dapagliflozin or any of the excipients in FARXIGA"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin, or Matching Placebo. The registry lists allocation as randomized. AMD is a leading cause of blindness in individuals over 50 years old, with dry AMD being the most common form.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at St Louis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.981Z"},{"nctId":"NCT07175285","title":"A Study in Participants With Active Systemic Lupus Erythematosus With Inadequate Response to Glucocorticoids and ≥2 Immunosuppressants","officialTitle":"Prospective, Observational Study in Participants With Active Systemic Lupus Erythematosus (SLE) (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and At Least 2 Immunosuppressants","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to characterize the efficacy and safety of current standard of care treatment options in participants with active systemic lupus erythematosus (SLE; including lupus nephritis) with inadequate response to glucocorticoids and at least two immunosuppressants","conditions":["Systemic Lupus Erythematosus (SLE)"],"keywords":["Systemic lupus erythematosus (SLE)"],"interventions":[{"type":"DRUG","name":"Current standard of care treatment options"}],"enrollment":223,"startDate":"2025-10-08","completionDate":"2028-03-24","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have signed and dated an Institutional Review Board/ Independent Ethics Committee (IRB/IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines\n* Participants must be ≥16 years of age at the time of signing the ICF\n* Meet the European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) 2019 classification criteria for systemic lupus erythematosus (SLE)\n* Have an inadequate response to glucocorticoids and ≥ 2 immunosuppressant therapies, one of which is a biologic therapy consistent with treatment guidelines, used for at least 3 months each. Eligibility is regardless of prior hydroxychloroquine or any anti-malarial treatment. Inadequate response is defined as a lack of response, insufficient response, or lack of sustained response after at least 3-month treatment with appropriate doses of a standard of care agent. Intolerance or contraindication may be considered as inadequate response provided it is documented and confirmed acceptable by the Adjudication Committee\n* Have active disease at study entry when signing ICF, defined as:\n\n  * ≥ 1 British Isles Lupus Assessment Group Index (BILAG) A OR ≥ 1 BILAG B with history of SLE manifestations that would qualify for a BILAG A within the last 24 months, AND\n  * Positive autoantibodies (at least one) to confirm diagnosis of SLE: Antinuclear antibody ≥1:160, anti-dsDNA, anti-Sm, anti-Ro (SSA), anti-La (SSB), or low complement proteins (C3 or C4)\n* Participants with lupus nephritis (LN) meeting the study eligibility criteria must have had a renal biopsy per standard of care within 6 months (± 30 days) prior to signing the ICF, indicating the presence of active Class III or IV LN (alone or in combination with Class V) according to the 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS), with \\< 60% interstitial fibrosis and tubular atrophy \\< 60% global glomerulosclerosis\n\nExclusion Criteria:\n\n* Pregnant women\n* Participants enrolled in concurrent interventional clinical trials involving investigational therapies or any other clinical trial\n* Participant is unwilling or unable to comply with routine clinical follow-up necessary for collection of study data","locations":[{"facility":"Local Institution - 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The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 223 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.281Z"},{"nctId":"NCT07175428","title":"Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation","officialTitle":"A Phase 2, Randomized, Multicenter, Open-label, Blinded-endpoint Study to Evaluate the Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against FXI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-ATLAS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.\n\nThe aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well do the study drugs reduce the risk of having a stroke\n* How much of REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)","conditions":["Atrial Fibrillation (AF)"],"keywords":["Bleeding","Stroke","Systemic embolism","Blood clots"],"interventions":[{"type":"DRUG","name":"REGN7508"},{"type":"DRUG","name":"REGN9933"},{"type":"DRUG","name":"Apixaban"}],"enrollment":1200,"startDate":"2025-10-20","completionDate":"2027-02-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol\n2. Meets one of the following:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve or\n   2. CHA2DS2-VA score ≥3 or\n   3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol\n3. Must have an International Normalization Ratio (INR) \\<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Has known moderate-to-severe mitral stenosis\n3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol\n4. Had an ischemic stroke within 2 days prior to randomization\n5. Has estimated Glomerular Filtration Rate (eGFR) \\<15 mL/min/1.73m\\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol\n6. Has a history of central nervous system bleeding within 30 days prior to randomization\n\nNote: Other protocol-defined Inclusion/ Exclusion criteria apply","locations":[{"facility":"SEC Clinical Research","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Shore Research Institute","city":"Fairhope","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Clinical Trials, Inc","city":"Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Coast Cardiology","city":"Encinitas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Cardiovascular Research Institute","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute of California Heart and Vein Specialists","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC at Southern California Heart Specialists","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empire Clinical Research","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cardiovascular Center","city":"Redding","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northbay Clinical Research Center","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiology Associates Medical Group","city":"Ventura","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Interventional Cardiology Medical Group","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nouvelle Clinical Research LLC","city":"Cutler Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Florida Research Organization LLC","city":"Medley","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inpatient Research Clinic LLC","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiovascular Center of Sarasota Foundation for Research and Education","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site Partners, LLC DBA Flourish Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grady Health System","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Sciences Research Building II","city":"Atlanta","state":"Georgia","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"NSC Research, Inc","city":"Johns Creek","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blue Coast Research Center, LLC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscan Physician Network, Indiana Heart Physicians","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana Medical Research","city":"Merrillville","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Reid Physician Associates","city":"Richmond","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Research, LLC","city":"West Monroe","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anderson Medical Research","city":"Ft. 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Research","city":"Uberlândia","state":"Minas Gerais","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sociedade Hospitalar Angelina Caron","city":"Campina Grande do Sul","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quanta Diagnostico por Imagem","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidade Catolica do Paraná (PUC) Trials","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nucleo de Pesquisa Clínica SS","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Ernesto Dornelles","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CoraCentro Pesquisa Clinica","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Estudos Procardio","city":"Blumenau","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"AngioKormann Blumenau","city":"Blumenau","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Cardiologia de Santa Catarina","city":"São José","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro De Pesquisa Clinica Do Coracao","city":"Aracaju","state":"Sergipe","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculdade de Medicina de Botucatu (UNESP)","city":"Botucatu","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Sao Francisco na Providencia de Deus","city":"Bragança Paulista","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto De Pesquisa Clinica de Campinas (Ipecc)","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital da Pontificia Universidade Catolica (PUC) Campinas","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CLINICOR - Clinica Cardiologica Ltda","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto, Centro Integrado de Pesquisa (CIP)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Dante Pazanese de Cardiologia","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta Hospital - Cardiology","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Victoria Cardiac Arrhythmia Trials","city":"Victoria","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GA Research Associates Ltd.","city":"Moncton","state":"New Brunswick","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health sciences North - Cardiology","city":"Greater Sudbury","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamilton Health Sciences Corporation","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamilton Medical Research Group (HMRG)","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr James Cha","city":"Oshawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heart Health Institute Research Inc. - Cardiology","city":"Scarborough Village","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Viacar Recherches Cliniques Inc. - Cardiologie","city":"Longueuil","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montreal Heart Institute","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CISSS du Bas-Saint-Laurent - Hopital regional de Rimouski - Cardiologie","city":"Rimouski","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diex Recherche Inc.","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CISSSLAN, Hopital Pierre-Le Gardeur","city":"Terrebonne","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diex Recherche Trois-rivieres","city":"Trois-Rivières","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Quebec-Universite Laval","city":"Québec","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Incidence of any bleeding"],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["dothan-alabama","fairhope-alabama","covina-california","encinitas-california","fremont-california","huntington-beach-california","pasadena-california","pomona-california","redding-california","santa-rosa-california","ventura-california","west-hills-california","cutler-bay-florida","medley-florida","miami-lakes-florida","sarasota-florida","winter-park-florida","atlanta-georgia","johns-creek-georgia","indianapolis-indiana","merrillville-indiana","richmond-indiana","west-monroe-louisiana","ft-washington-maryland","boston-massachusetts","farmington-hills-michigan","flint-michigan","maplewood-minnesota","greensboro-north-carolina","marion-ohio","maumee-ohio","rapid-city-south-dakota","jefferson-city-tennessee","amarillo-texas","mckinney-texas","missouri-city-texas","odessa-texas","tyler-texas","clinton-utah","ciudad-autonoma-de-buenos-aires-argentina","ramos-mej-a-argentina","temperley-argentina","rosario-argentina","buenos-aires-argentina","c-rdoba-argentina","santa-fe-argentina","goi-nia-brazil","belo-horizonte-brazil","po-os-de-caldas-brazil","uberl-ndia-brazil","campina-grande-do-sul-brazil","curitiba-brazil","porto-alegre-brazil","blumenau-brazil","s-o-jos-brazil","aracaju-brazil","botucatu-brazil","bragan-a-paulista-brazil","campinas-brazil","ribeir-o-preto-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","edmonton-canada","victoria-canada","moncton-canada","greater-sudbury-canada","hamilton-canada","oshawa-canada","scarborough-village-canada","longueuil-canada","montreal-canada","rimouski-canada","sherbrooke-canada","terrebonne-canada","trois-rivi-res-canada","qu-bec-canada"],"enrichment":{"headline":"Phase 2: testing REGN7508 for Atrial Fibrillation (AF)","inPlainEnglish":"This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly.","whoItsFor":["Ages 18 Years to any","Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol","Meets one of the following:","CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve or","CHA2DS2-VA score ≥3 or","CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol","Must have an International Normalization Ratio (INR) \\<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)"],"whoShouldSkip":["Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)","Has known moderate-to-severe mitral stenosis","Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol","Had an ischemic stroke within 2 days prior to randomization","Has estimated Glomerular Filtration Rate (eGFR) \\<15 mL/min/1.73m\\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol","Has a history of central nervous system bleeding within 30 days prior to randomization","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are REGN7508, REGN9933, or Apixaban. The registry lists allocation as randomized. This study is researching experimental drugs called REGN7508 and REGN9933.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 1,200 people at 91 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.739Z"},{"nctId":"NCT07178951","title":"Neurolysis for the Treatment of Medial Chronic Knee Pain Due to Osteoarthritis","officialTitle":"Safety and Feasibility of the Neurolyser XR Device for the Treatment of Predominantly Medial Chronic Knee Pain Due to Osteoarthritis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"FUSMobile Inc.","sponsorClass":"INDUSTRY","summary":"This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve. The sound waves cause a break in the nerve which carries pain signals. Sound waves transmit through the skin so there is no need for needles. The procedure takes approximately one hour. The device has been approved in Health Canada and Europe for the treatment of lower back pain. This study is to evaluate the use of the same device for people in Canada who have knee pain related to osteoarthritis.","conditions":["Osteoarthritis (OA) of the Knee","Knee Pain Arthritis","Chronic Knee Pain"],"keywords":["osteoarthritis","knee pain","focused ultrasound","nerve ablation"],"interventions":[{"type":"DEVICE","name":"Neurotomy of the medial sensory articular branches"}],"enrollment":10,"startDate":"2026-09-09","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Moderate to severe, predominantly medial chronic knee pain\n2. Age adult \\>18 years old\n3. WOMAC Score of 30 or higher\n4. NRS\\>6 with ambulation\n5. Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)\n6. Participants in whom the measured skin to bone depth is 2-6 cm using imaging ultrasound and ultrasound gel pad in the upper medial and lower medial joint capsule targets.\n\nExclusion Criteria:\n\n1. Individuals meeting any of the following criteria are not eligible for participation in this study:\n2. Individuals after any surgery associated with altered integrity of bone structure\n3. Individuals with severe pain in the second knee\n4. Individuals unable to understand and complete the research questionnaires in the official language\n5. Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PI decision\n6. Individuals with extensive scarring of the skin and tissue overlying the treatment area\n7. Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project\n8. Individuals with active inflammatory (e.g., rheumatoid) arthritis\n9. Individuals with concomitant mental health disorders, excluding compensated mood disorders\n10. Individuals with altered perception and processing of pain: Average NRS \\> 9, PCS\\>30, SSS-8 \\> 11, CSI\\>40 \\[46\\], \\[47\\], \\[48\\]\n11. Individuals with a first-degree family member already enrolled in this study\n12. Individuals who are scheduled for any interventional/surgical procedure within 3 months from the screening date, excluding trivial surgeries (e.g., cataract, skin tumors)\n13. Inability to attend follow-up visits and physiotherapy due to travel distance or other restrictions\n14. Symptomatic multifocal nociplastic chronic pain (e.g., fibromyalgia, generalized osteoarthritis) or any other chronic pain condition that could influence symptoms.\n15. Participants who have undergone radiofrequency ablation of the genicular nerves in the planned treatment limb within the preceding 6 months.","locations":[{"facility":"Unika Medical Centre","city":"North York","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melissa Diep Research Coordinator","phone":"647-740-0160 Canada","email":"assistant@unikamed.com"}],"primaryOutcomes":["A positive clinical outcome will be measured by a 2-point reduction in the Numerical Rating Score (NRS)","Safety will be measured by the incidence and severity of treatment-related adverse events."],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["north-york-canada"],"enrichment":{"headline":"Not a traditional drug phase: Neurotomy of the medial sensory articular branches for Osteoarthritis (OA) of the Knee","inPlainEnglish":"This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee. The sound waves are tightly focused on a specific area of the nerve.","whoItsFor":["Ages 18 Years to any","Moderate to severe, predominantly medial chronic knee pain","Age adult \\>18 years old","WOMAC Score of 30 or higher","NRS\\>6 with ambulation","Radiological confirmation of knee osteoarthritis (Kellgren-Lawrence Scale: 2-4)","Participants in whom the measured skin to bone depth is 2-6 cm using imaging ultrasound and ultrasound gel pad in the upper medial and lower medial joint capsule targets"],"whoShouldSkip":["Individuals meeting any of the following criteria are not eligible for participation in this study:","Individuals after any surgery associated with altered integrity of bone structure","Individuals with severe pain in the second knee","Individuals presenting with any severe medical condition preventing the participant from safely and effectively being treated in the study or reporting study outcomes, per PI decision","Individuals with extensive scarring of the skin and tissue overlying the treatment area","Individuals enrolled in or planned to be enrolled in another clinical trial during the duration of this research project","Individuals with active inflammatory (e.g., rheumatoid) arthritis"],"whatHappens":"If you join, the listed intervention(s) are Neurotomy of the medial sensory articular branches. The registry lists allocation as na. This study involves the use of sound waves to block pain signals caused by osteoarthritis of the knee.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at North York. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.504Z"},{"nctId":"NCT07179601","title":"Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)","officialTitle":"Hemorrhoidal Artery Embolization: Longitudinal Impact On Symptoms (HELIOS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, Los Angeles","sponsorClass":"OTHER","summary":"Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.","conditions":["Internal Hemorrhoids","HAE"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Hemorrhoidal artery embolization"}],"enrollment":22,"startDate":"2025-08-05","completionDate":"2028-09-30","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 90 years\n* Ability to give written informed consent and to comply with the follow-up visits\n* Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine\n* Refusal of or contraindication to surgery\n* Refusal of or contraindication to other minimally invasive hemorrhoid treatments\n* Grade I to III hemorrhoids\n* Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year\n* Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization\n\nExclusion Criteria:\n\n* Asymptomatic patients\n* Patients who ever had previous colorectal surgery\n* Grade IV hemorrhoids\n* Colorectal disease other than hemorrhoids that could result in bleeding\n* Anatomic findings on CTA that would preclude successful embolization\n* Contraindication to iodinated contrast\n* Inability to give written informed consent\n* Active infection or malignancy\n* Recent (within 12 months) or active cigarette use\n* History of inflammatory bowel disease\n* Uncorrectable bleeding diathesis\n* Presence of portal hypertension or rectal varices seen on pre-procedure CTA or anoscopy/colonoscopy\n* No SRA or MRA supply to the CCR seen intra-procedural angiogram","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Renato Escobar","phone":"310-956-6161","email":"raescobar@mednet.ucla.edu"},{"name":"Lucas Cusumano, MD","phone":"","email":""}],"primaryOutcomes":["Proportion of patients with decrease in bleeding related symptoms of internal hemorrhoids as defined as a two-point decrease in French Bleeding Score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: Hemorrhoidal artery embolization for Internal Hemorrhoids","inPlainEnglish":"Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue.","whoItsFor":["Ages 18 Years to 90 Years","Symptomatic hemorrhoidal disease with French Bleeding Score (FBS) of at least four out of nine","Refusal of or contraindication to surgery","Refusal of or contraindication to other minimally invasive hemorrhoid treatments","Grade I to III hemorrhoids","Previous anoscopy or colonoscopy demonstrating internal hemorrhoids within 1 year","Supply of the CCR from either the SRA or MRA on intra-procedural angiogram prior to embolization"],"whoShouldSkip":["Asymptomatic patients","Patients who ever had previous colorectal surgery","Grade IV hemorrhoids","Colorectal disease other than hemorrhoids that could result in bleeding","Anatomic findings on CTA that would preclude successful embolization","Contraindication to iodinated contrast","Active infection or malignancy"],"whatHappens":"If you join, the listed intervention(s) are Hemorrhoidal artery embolization. The registry lists allocation as na. Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 22 people at Los Angeles. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.415Z"},{"nctId":"NCT07180108","title":"PRoMiSS: Psilocybin and the Role of Music in Set and Setting","officialTitle":"PRoMiSS: Psilocybin and the Role of Music in Set and Setting","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are:\n\nDoes autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists?\n\nHow are brain and body responses - including EEG activity, respiration, heart rate, and skin conductance - influenced by autobiographically salient music under psilocybin?\n\nDo brain and body responses to specific music features differ when the music is autobiographically salient compared to non-salient playlists?\n\nResearchers will compare five music conditions: three conditions where an 80-minute block of autobiographically salient music is placed at different points in the 6-hour psilocybin session (0-80 minutes, 80-160 minutes, or 240-320 minutes), a standardized Johns Hopkins psilocybin playlist, and an ambient playlist with no autobiographical content.\n\nParticipants will:\n\n* Take a single oral dose of psilocybin (25 mg) during one study session\n* Listen to one of the five music conditions while reclining in a comfortable setting\n* Complete questionnaires about emotions, acute, subjective effects, insight, etc.\n* Undergo EEG and physiological monitoring (respiration, heart rate, skin conductance) during the session\n* Complete MRI brain scans before the session and 1 week after psilocybin\n* Return for follow-ups at 1 day, 1 week, and 1 month after psilocybin\n* At 1 month, complete a qualitative interview and a nondrug EEG music listening session, where the participant's hear either music from the participant's own psilocybin session or music from another participant's session","conditions":["Psilocybin","Music Intervention"],"keywords":["Psilocybin","Set and Setting","Music Cognition","Music-evoked autobiographical memory","Emotion","Altered State of Consciousness","Psychedelics","Memory"],"interventions":[{"type":"DRUG","name":"Psilocybin (high dose)"},{"type":"BEHAVIORAL","name":"Playlist 1"},{"type":"BEHAVIORAL","name":"Playlist 2"},{"type":"BEHAVIORAL","name":"Playlist 3"},{"type":"BEHAVIORAL","name":"Playlist 4"},{"type":"BEHAVIORAL","name":"Playlist 5"}],"enrollment":100,"startDate":"2025-08-12","completionDate":"2028-06","sex":"ALL","minAge":"21 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* • Fluent in English\n\n  * No hearing impairment\n  * Right-handed\n  * Have a screening weight ≥ 40 kg (88.18 lbs) with BMI ≥16.\n  * Be medically stable as determined by screening for medical problems via a personal interview, a medical history, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n  * Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.\n  * Agree to refrain from using any psychoactive drugs within 24 hours of each drug administration. The exceptions are caffeine and nicotine, which can be consumed before arriving for drug administration sessions.\n  * Agree not to take any as needed (PRN) medications on the mornings of drug sessions\n  * Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n  * Agree not to use any hair conditioner 24-hours before EEG sessions (Visits 3, 4, and 7)\n  * Females of child-bearing potential must agree to use highly effective methods of contraception (defined as use of an intrauterine device, vaginal ring, or implanted or oral hormonal contraceptives) during the study\n  * Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti- inflammatory drugs, and common doses of vitamins and minerals.\n  * Have limited lifetime use of hallucinogens, if any (the following criteria are preferred: no use in the past 5 years; total hallucinogen use less than 10 times)\n  * Proof of COVID-19 vaccination.\n\nExclusion Criteria:\n\n* • Unusually low reward response to music (defined as a majority of responses of \"1\" on the BMRQ)\n\n  * Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of contraception\n  * Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), prolonged corrected QT interval (QTc) interval (i.e., QTc \\> 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year\n  * Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n  * Currently taking psychoactive prescription medication on a regular (e.g., daily) basis - exceptions may be made at the discretion of the study team physician for participants taking medications with short half-life if participants are able to abstain from taking the medication during session days (e.g. methylphenidate taken for attention or hyperactivity)\n  * Currently taking on a regular (e.g., daily) basis any medications that have a primary centrally-acting serotonergic effect, including Monoamine Oxidase Inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.\n  * Current or past history of meeting Diagnostic and Statistical Manual (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder\n  * Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder. If a nicotine user, consuming the equivalent of more than 10 cigarettes per day.\n  * Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar disorder with mania (except substance/medication-induced or due to another medical condition)\n  * Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n  * History of a medically significant suicide attempt as assessed by a study team clinician\n  * Standard MRI contraindications: head trauma, claustrophobia incompatible with scanning, contraindicated medical devices, prior history as a metal worker and/or certain metallic objects in the body -- must complete MRI screening form and be approved by MRI technologist before each scan\n  * History of migraine.\n  * History of angiotensin-converting enzyme inhibitor (ACEi) angioedema","locations":[{"facility":"Center for Psychedelics and Consciousness Research in the Behavioral Biology Research Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David S Rosen, PhD","phone":"609-502-8900","email":"drosen9@jh.edu"},{"name":"Sabina Vitola, M.S.","phone":"571-351-9890","email":"mvitola1@jh.edu"}],"primaryOutcomes":["Challenging Experiences Questionnaire","Psychological Insight Questionnaire (PIQ)","Core Flow State Scale (C-FSS)","Mystical Experiences Questionnaire (MEQ-30)","Experience of Unity (11D-ASC)","Change in EEG oscillatory power across canonical frequency bands (µV²/Hz)","Music Ratings: Autobiographical Salience","Spiritual Experience - Altered States of Consciousness (ASC-11D)","Blissful State (11D-ASC)","Insightfulness (11D-ASC)","Disembodiment (11D-ASC)","Impaired Cognition & Control (11D ASC)","Anxiety (11D-ASC)","Complex Imagery (11D-ASC)","Elementary Imagery (11D-ASC)","Audio-Visual Synesthesia (11D-ASC)","Changed Meaning of Percepts (11D-ASC)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1: testing Psilocybin (high dose) for Psilocybin","inPlainEnglish":"The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75. The main questions it aims to answer are: Does autobiographically salient music lead to stronger emotional responses to music, greater acute subjective effects, and more lasting improvements in mood, affect, and well-being compared to standardized or ambient playlists?","whoItsFor":["Ages 21 Years to 75 Years","No hearing impairment","Have a screening weight ≥ 40 kg (88.18 lbs) with body-mass index (BMI) ≥16","Be medically stable as determined by screening for medical problems via a personal interview, a medical history, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests","Agree to refrain from using any psychoactive drugs within 24 hours of each drug administration. The exceptions are caffeine and nicotine, which can be consumed before arriving for drug administration sessions","Agree not to take any as needed (PRN) medications on the mornings of drug sessions","Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration","Agree not to use any hair conditioner 24-hours before EEG sessions (Visits 3, 4, and 7)"],"whoShouldSkip":["Unusually low reward response to music (defined as a majority of responses of \"1\" on the BMRQ)","Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of contraception","Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia","Current or past history of meeting Diagnostic and Statistical Manual (DSM-5) criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition), or Bipolar I Disorder","Current or history within one year of meeting DSM-5 criteria for a moderate or severe substance use disorder. If a nicotine user, consuming the equivalent of more than 10 cigarettes per day","Have a first-degree relative with schizophrenia spectrum or other psychotic disorders, or bipolar disorder with mania (except substance/medication-induced or due to another medical condition)","Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (high dose), Playlist 1, or Playlist 2. The registry lists allocation as na. The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 100 people at Baltimore. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.102Z"},{"nctId":"NCT07180979","title":"PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty","officialTitle":"Comparison of Pericapsular Nerve Group (PENG) Block Versus Lumbar Erector Spinae Plane Block (L-ESPB) Combined With Sacral ESPB (S-ESPB) for Analgesia in Total Hip Arthroplasty (THA): A Randomized Clinical Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.\n\nThe main questions it aims to answer are:\n\nDoes the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique? Which method provides better pain relief, preserves muscle strength, and supports earlier mobilization? Researchers will compare the Pericapsular Nerve Group (PENG) block with the combination of Lumbar and Sacral Erector Spinae Plane Blocks (L-ESPB + S-ESPB) to see which provides better pain control, fewer side effects, and faster recovery.\n\nParticipants will:\n\nBe randomly assigned to receive one of the two types of ultrasound-guided regional anesthesia Undergo standard hip replacement surgery under spinal anesthesia Be monitored for pain scores, opioid use, time to first walking, muscle strength, satisfaction, and side effects over the first 48 hours after surgery.","conditions":["Hip Osteoarthritis","Hip Arthropathy","Hip Pain Chronic"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ropivacaine 0.5% Injectable Solution"},{"type":"DRUG","name":"Ropivacaine 0.2% Injectable Solution"},{"type":"DRUG","name":"Ropivacaine 0.2% Injectable Solution"}],"enrollment":90,"startDate":"2025-09-15","completionDate":"2027-09-30","sex":"ALL","minAge":"65 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 65 years\n* ASA physical status I-III\n* Elective unilateral THA via posterior or lateral approach\n* Informed consent provided\n\nExclusion Criteria:\n\n* Allergy to study drugs (ropivacaine, dexamethasone)\n* Chronic opioid use (\\>30 MME/day)\n* Coagulopathy or infection at the injection site\n* BMI \\> 40 kg/m²\n* Pre-existing motor weakness or neuropathy in the affected limb\n* Cognitive impairment precluding informed consent","locations":[{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Malgorzata Reysner, M.D. Ph.D.","phone":"+48 61 873 83 03","email":"mreysner@ump.edu.pl"}],"primaryOutcomes":["Total opioid consumption"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Phase 4: testing Ropivacaine 0.5% Injectable Solution for Hip Osteoarthritis","inPlainEnglish":"The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery. The main questions it aims to answer are: Does the PENG block reduce opioid use in the first 48 hours after surgery more effectively than the combined L-ESPB + S-ESPB technique?","whoItsFor":["Ages 65 Years to 100 Years","ASA physical status I-III","Elective unilateral THA via posterior or lateral approach"],"whoShouldSkip":["Allergy to study drugs (ropivacaine, dexamethasone)","Chronic opioid use (\\>30 MME/day)","Coagulopathy or infection at the injection site","Pre-existing motor weakness or neuropathy in the affected limb"],"whatHappens":"If you join, the listed intervention(s) are Ropivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution, or Ropivacaine 0.2% Injectable Solution. The registry lists allocation as randomized. The goal of this clinical trial is to evaluate whether different types of regional anesthesia can improve pain control and functional recovery after total hip arthroplasty in adult patients undergoing elective hip replacement surgery.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 90 people at Poznan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.514Z"},{"nctId":"NCT07185841","title":"Safety and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)","officialTitle":"A Multicenter, Open-label, Phase I/II Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral HX9428 Tablets in Subjects With Wet Age-related Macular Degeneration (wAMD)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Fujian Haixi Pharmaceuticals Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)","conditions":["Wet Age-related Macular Degeneration (AMD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"HX9428 tablet"}],"enrollment":198,"startDate":"2025-07-01","completionDate":"2028-07-01","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must meet the following criteria for study entry:\n\n  1. Age ≥50 years and ≤80 years (Phase I), Age ≥50 years and ≤85 years (Phase II) at the time of signing informed consent, male or female;\n  2. Active choroidal neovascularization (CNV) secondary to AMD, as evidenced on fluorescein fundus angiography (FFA) and optical coherence tomography (OCT) (Active CNV is defined as the presence of subretinal or intraretinal fluid or leakage); A total lesion size of \\<12 disc areas on FFA ;\n  3. Treatment-naive , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid or cystoid macular edema;\n  4. ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;\n  5. Other protocol-specified inclusion criteria may apply\n\nExclusion Criteria:\n\n* Subjects who meet any of the following criteria will be excluded from this study:\n\n  1. Subjects diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;\n  2. On FFA/CFP: subretinal hemorrhage of \\>50 % of the total lesion area or that involves the fovea; fibrosis or atrophy of \\>50 % of the total lesion area or that involves the fovea;\n  3. CNV due to causes other than AMD;\n  4. Any condition in the study eye that could compromise best-corrected visual acuity;\n  5. Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;\n  6. Refractive error exceeding -6.00 D spherical equivalent;\n  7. Ocular surgery performed in the study eye within 90 days before screening;\n  8. Previous treatment with photodynamic therapy (within 120 days of screening), external-beam radiotherapy, macular laser photocoagulation, macular surgery, or transpupillary thermotherapy;\n  9. Systemic anti-VEGF therapy administered within 90 days before the first dose;\n  10. Pregnant or lactating women;\n  11. Known hypersensitivity or contraindication to any study-related procedure drugs;\n  12. History of severe cardiac disease, symptomatic congestive heart failure, unstable angina, acute coronary syndrome, myocardial infarction, coronary revascularization, thrombotic event, or bleeding episode within 6 months prior to the start of study drug, uncontrolled hypertension (systolic blood pressure\\> 150 mmHg and/or diastolic blood pressure \\> 100 mmHg on optimal medical therapy), or ventricular arrhythmia requiring ongoing treatment;\n  13. Stroke within 12 months or transient ischemic attack within 6 months of enrolment；\n  14. Poorly controlled diabetes (HbA1c ≥ 12 %);\n  15. Other protocol-specified exclusion criteria may apply.","locations":[{"facility":"Beijing Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Junqing Li","phone":"+86 0591-87519936","email":"junqing.li@hxpharma.com"}],"primaryOutcomes":["Phase I : Dose-Limiting Toxicity (DLT)","Phase II： Mean change of letters from baseline in Best Corrected Visual Acuity(BCVA)"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing HX9428 tablet for Wet Age-related Macular Degeneration (AMD)","inPlainEnglish":"This study will measure the safety, tolerability, pharmacokinetics and preliminary how well it works of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)","whoItsFor":["Ages 50 Years to 85 Years","Participants must meet the following criteria for study entry:","Treatment-who have not tried this kind of treatment before , or previous anti-VEGF treatment that was effective and discontinued for more than 3 months, with OCT evidence of subretinal fluid or cystoid macular edema;","ETDRS BCVA 19 to 78 letters in the study eyes( corresponding to a Snellen equivalent of approximately 20/32 to 20/400) ;","Other protocol-specified who can join may apply"],"whoShouldSkip":["Subjects who meet any of the following criteria will be excluded from this study:","Subjects diagnosed with polypoidal choroidal vasculopathy by Indocyanine Green(ICG) angiography who are at high risk of massive hemorrhage;","On FFA/CFP: subretinal hemorrhage of \\>50 % of the total lesion area or that involves the fovea; fibrosis or atrophy of \\>50 % of the total lesion area or that involves the fovea;","CNV due to causes other than AMD;","Any condition in the study eye that could compromise best-corrected visual acuity;","Active ocular inflammation or infection in either eye or a history of idiopathic or autoimmune-related uveitis;","Refractive error exceeding -6.00 D spherical equivalent;"],"whatHappens":"If you join, the listed intervention(s) are HX9428 tablet. The registry lists allocation as na. This study will measure the safety, tolerability, pharmacokinetics and preliminary how well it works of Oral HX9428 tablets in patients with wet age-related macular degeneration(wAMD)","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 198 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.147Z"},{"nctId":"NCT07185997","title":"Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations","officialTitle":"A Global, Phase 3, Randomized, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of Osimertinib or Afatinib as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic Non-Small-Cell Lung Cancer With Epidermal Growth Factor Receptor P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations (ALPACCA)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"ArriVent BioPharma, Inc.","sponsorClass":"INDUSTRY","summary":"Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. Participants will be randomized in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.","conditions":["Non-Small-Cell Lung Cancer","Metastatic Non-Small-Cell Lung Cancer","Advanced Non-Small-Cell Lung Cancer","EGFR P-Loop and Alpha C-Helix Compressing","EGFR PACC","EGFR Uncommon Mutations"],"keywords":["Non-Small Cell Lung Cancer (NSCLC)","PACC","Firmonertinib","Furmonertinib","AST2818","FURMO-006","Drug-Therapy","Metastatic Non-Small Cell Lung Cancer","Advanced Non-Small Cell Lung Cancer","NSCLC","Osimertinib","Afatinib","metastatic NSCLC first-line treatment","Carcinoma NSCLC","Respiratory tract neoplasms","Bronchial Neoplasms","Protein Kinase Inhibitors","tyrosine kinase inhibitor (TKI)","Alflutinib","Lung neoplasms","EGFR kinase domain mutations","EGFR activating mutation","EGFR mutation of unknown significance","Non-classical EGFR mutation","EGFR uncommon mutations","EGFR atypical mutations","EGFR","G719X","S7681","E709X","E709_T710delinsD","G779F","L747X","V774M","L747P/S","R776C/H","G724S","E736K","1740_K745dup","N771G","K757M/R","V769L/M"],"interventions":[{"type":"DRUG","name":"Firmonertinib"},{"type":"DRUG","name":"EGFR-TKI inhibitor based on investigator's choice"}],"enrollment":480,"startDate":"2025-12-17","completionDate":"2029-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Eligibility Criteria:\n\n* Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy.\n* Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing.\n* No prior systemic anticancer therapy regimens received for locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) including prior treatment with any Epidermal Growth Factor Receptor (EGFR)-targeting agents (e.g., previous (EGFR) TKIs, monoclonal antibodies, or bispecific antibodies).\n* Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months.\n* Patients with asymptomatic CNS metastases are eligible.\n* List of eligible PACC mutations:\n\nE709X, E709A, E709H, E709V, E709K E709\\_T710delinsD, E709\\_T710delinsA, E709\\_T710delinsG, L718M, L718P, L718Q, L718V, G719X, G719A, G719C, G719D, G719S, G724S, E736K, I740\\_K745dup, I740\\_K745dupIPVAIK, I744\\_K745insKIPVAI, L747P, L747S, K757M, K757R, V765L, S768I, S768\\_V769delinsIL, S768\\_V769delinsIM, S768\\_V769delinsPL, V769L, V769M, N771G, H773\\_V774delinsLM, V774M, R776C, R776H, G779F, L792H, G796S, T854A, T854S, T854I, A647T, R675W, S768C, A755D, A750\\_I759delinsPN, T751\\_I759delinsN","locations":[{"facility":"St. Jude Medical Center","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC/Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence St. Joseph Hospital","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Davis Comprehensive Cancer Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF Medical Center-Mission Bay","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Medical Center","city":"Vallejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Health","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Cancer Specialists","city":"Arlington Heights","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Hospital and Health Sciences Systems","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health/R.J. Zuckerberg Cancer Center","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laura & Isaac Perlmutter Cancer Center at NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Hospitals","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fox Chase Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenandoah Oncology, P.C.","city":"Winchester","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Cancer Institute","city":"Edmonds","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blacktown Cancer and Haematology Centre","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chris O'Brien Lifehouse","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"GenesisCare North Shore Health Hub","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Health","city":"Heidelberg","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Health Services, Tom Baker Cancer Centre","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta - Cross Cancer Institute (CCI)","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC Cancer Vancouver Centre","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brampton Civic Hospital, William Osler Health 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3: testing Firmonertinib for Non-Small-Cell Lung Cancer","inPlainEnglish":"Global, Phase 3, randomly assigned, multicenter, open-label study evaluating the how well it works and safety of firmonertinib at a dose level of 240 mg QD compared to investigator's choice of osimertinib (80 mg QD) or afatinib (40 mg QD) in participants who have locally advanced or metastatic NSCLC with EGFR PACC mutations, and who have not received any prior therapy for advanced disease. you would be randomly assigned in a 1:1 ratio to treatment with firmonertinib or osimertinib or afatinib and will take the assigned dose daily.","whoItsFor":["Ages 18 Years to any","Key Eligibility Criteria:","Histologically or cytologically documented, locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) not amenable to curative surgery or radiotherapy","Documented results of the presence of an Epidermal Growth Factor Receptor (EGFR) PACC mutation in tumor tissue or blood from local testing","Patients who have received prior neo-adjuvant and/or adjuvant chemotherapy, immunotherapy, or chemo radiotherapy for non-metastatic disease must have experienced a treatment free interval of at least 12 months","Patients with asymptomatic CNS metastases are eligible","List of eligible PACC mutations:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Firmonertinib, or EGFR-TKI inhibitor based on investigator's choice. 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or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","anaheim-california","lancaster-california","los-angeles-california","colorado-springs-colorado","hialeah-florida","jacksonville-florida","kissimmee-florida","lakewood-rch-florida","lighthouse-pt-florida","margate-florida","orlando-florida","belleville-illinois","chicago-illinois","des-plaines-illinois","glenview-illinois","gurnee-illinois","new-albany-indiana","louisville-kentucky","boston-massachusetts","clinton-township-michigan","flowood-mississippi","utica-new-york","dayton-ohio","providence-rhode-island","greenville-south-carolina","cordova-tennessee","cedar-park-texas","dallas-texas","fort-worth-texas","garland-texas","lubbock-texas","san-antonio-texas","tyler-texas","webster-texas","ogden-utah","richmond-virginia","roanoke-virginia","bellevue-washington","vienna-austria","bras-lia-brazil","campinas-brazil","caxias-do-sul-brazil","curitiba-brazil","juiz-de-fora-brazil","macei-brazil","porto-alegre-brazil","s-o-jos-dos-campos-brazil","s-o-paulo-brazil","taja-brazil","teresina-brazil","hamilton-canada","london-canada","mississauga-canada","trois-rivi-res-canada","changzhou-china","chongqing-china","fuzhou-china","hangzhou-china","kunming-china","nanjing-china","qingdao-china","shenyang-china","shijiazhuang-china","taian-china","wuhan-china","wuxi-china","copenhagen-denmark","gistrup-denmark","odense-denmark","berlin-germany","dachau-germany","erlangen-germany","regensburg-germany","ulm-germany","b-k-scsaba-hungary","budapest-hungary","gy-ngy-s-hungary","tatab-nya-hungary","v-c-hungary","ahmedabad-india","chennai-india","coimbatore-india","hubli-india","hyderabad-india","new-delhi-india","pune-india","rajkot-india","milan-italy","roma-italy","rozzano-italy","fukuoka-japan","kamakura-japan","kashiwa-japan","osaka-japan","sakura-japan","sapporo-japan","chihuahua-city-mexico","durango-mexico","guadajalara-mexico","guadalajara-mexico","mexico-city-mexico","san-pedro-garza-garc-a-mexico","tijuana-mexico","tlalnepantla-mexico","tlalpan-mexico","veracruz-mexico","nijmegen-netherlands","tilburg-netherlands","katowice-poland","piotrkow-trybunalski-poland","poznan-poland","szczecin-poland","warsaw-poland","zamo-poland","bucharest-romania","constan-a-romania","satu-mare-romania","timi-oara-romania","barcelona-spain","fuenlabrada-spain","gij-n-spain","madrid-spain","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","eski-ehir-turkey-t-rkiye","hatay-turkey-t-rkiye","i-zmit-turkey-t-rkiye","malatya-turkey-t-rkiye","mersin-turkey-t-rkiye","sur-turkey-t-rkiye"],"enrichment":{"headline":"Phase 2: testing LY4268989 for Ulcerative Colitis","inPlainEnglish":"The main purpose of the study is to measure the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC). Study participation will last approximately 118 weeks, including 104 weeks of treatment and may include up to 21 visits.","whoItsFor":["Ages 18 Years to 80 Years","Have had an established diagnosis of UC of ≥3 months in before baseline, which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC","Have moderately to severely active UC as defined by a mMS of 5 to 9 with an ES ≥2 confirmed by central reader at screening endoscopy and RB ≥1","Participants with greater than 8 years of UC symptoms have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local country or regional medical guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization","Are up-to-date on colorectal cancer surveillance per local society guidelines","Have an inadequate response to, loss of response to, or intolerance to at least 1 of the medications:","Conventional-failed participants: Participants who have had an inadequate response to or a loss of response to or are intolerant to at least 1 of the following medications: corticosteroids or immunomodulators (Does not apply to US)","NOTE: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate (Applies to the US)"],"whoShouldSkip":["Have a current diagnosis of","Inflammatory Bowel Disease (IBD) unclassified (formerly known as indeterminate colitis), or","primary sclerosing cholangitis","Have had or will need bowel resection or intestinal or intra-abdominal surgery","Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic","Have any adenomatous polyp occurring in areas of the colon not involved by colitis, that has not been removed","Note: If such an adenomatous polyp has been completely removed and shows only low-grade dysplasia, this criterion would no longer apply"],"whatHappens":"If you join, the listed intervention(s) are LY4268989, Mirikizumab, or LY4268989 Placebo. The registry lists allocation as randomized. The main purpose of the study is to measure the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 252 people at 147 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.207Z"},{"nctId":"NCT07187063","title":"Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer","officialTitle":"Using Urine Tumor DNA to De-Intensify Surveillance in Non-Muscle Invasive Bladder Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Lahey Clinic","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.","conditions":["Non-muscle Invasive Bladder Cancer (NMIBC)"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"UroAmp Test (Convergent Genomics, Inc.)"}],"enrollment":56,"startDate":"2025-01-01","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* AUA high-risk bladder cancer1\n* Received induction BCG or gemcitabine/docetaxel\n* Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)\n\nExclusion Criteria:\n\n* High-risk NMIBC within 3 years\n* Prior induction intravesical therapy\n* Variant histology\n* Concurrent upper tract disease","locations":[{"facility":"Lahey Hospital and Medical Center","city":"Burlington","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Linda Topjian","phone":"7817448420","email":"Linda.M.Topjian@lahey.org"},{"name":"Colette Osborne","phone":"","email":"Colette.A.Osborne@lahey.org"}],"primaryOutcomes":["Number of cystoscopies"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["burlington-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: UroAmp Test (Convergent Genomics, Inc.) for Non-muscle Invasive Bladder Cancer (NMIBC)","inPlainEnglish":"The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.","whoItsFor":["Ages 18 Years to any","AUA high-risk bladder cancer1","Received induction BCG or gemcitabine/docetaxel","Negative initial post-induction therapy assessment (negative cytology and cystoscopy +/- biopsy)"],"whoShouldSkip":["High-risk NMIBC within 3 years","Prior induction intravesical therapy","Concurrent upper tract disease"],"whatHappens":"If you join, the listed intervention(s) are UroAmp Test (Convergent Genomics, Inc.). The registry lists allocation as randomized. The goal of this clinical trial is to use urine tumor DNA (utDNA) as an indicator for non-muscle invasive bladder cancer to identify patients suitable for less frequent cystoscopy surveillance.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 56 people at Burlington. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.317Z"},{"nctId":"NCT07187635","title":"Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer","officialTitle":"The Guiding Value of Urinary Tumor DNA Testing in Repeat Transurethral Resection of Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized Controlled, Multi-Center Clinical Study (Truce-LB01)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Tianjin Medical University Second Hospital","sponsorClass":"OTHER","summary":"Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information. However, the benefits of routine re-TURBT for all high-risk patients remain controversial, as many patients may not have residual disease, while the procedure carries surgical and anesthetic risks, physical and psychological burden, and additional healthcare costs.\n\nUrine tumor DNA (utDNA) refers to DNA fragments shed by tumor cells into urine. It can be detected using molecular assays with high sensitivity and specificity, offering a non-invasive method for bladder cancer diagnosis and surveillance. Previous studies have shown that positive utDNA results after initial TURBT may be associated with residual disease and higher recurrence risk.\n\nThis multicenter, randomized controlled trial aims to evaluate whether utDNA testing can accurately identify NMIBC patients who are most likely to benefit from re-TURBT, thereby guiding the decision to perform the procedure. The goal is to optimize patient selection for re-TURBT, reduce unnecessary surgeries, and improve patient quality of life while maintaining oncologic safety.","conditions":["Bladder Cancer","Liquid Biopsy","Repeat Transurethral Resection of Bladder Tumor"],"keywords":["bladder cancer","liquid biopsy","second transurethral resection of bladder tumor"],"interventions":[{"type":"PROCEDURE","name":"Second Transurethral Resection of Bladder Tumor (re-TURBT)"},{"type":"DIAGNOSTIC_TEST","name":"utDNA Testing (Urine Tumor DNA Detection)"}],"enrollment":350,"startDate":"2025-09-28","completionDate":"2027-10-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged 18 years or older.\n2. Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease.\n3. Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\\>50%).\n4. At least one of the following conditions:\n\n   1. Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection.\n   2. Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \\[CIS\\]).\n   3. T1 stage tumor.\n5. Willingness to provide a 50 mL urine sample between 2-6 weeks after the initial TURBT and prior to re-TURBT.\n6. Willingness to provide tumor tissue samples for pathological examination.\n7. Willingness to undergo genetic testing required for the trial.\n\nExclusion Criteria:\n\n1. Contraindications to transurethral resection of bladder tumor (TURBT).\n2. Concurrent malignancy of the upper urinary tract (ureter or renal pelvis).","locations":[{"facility":"Nanchang Second People's Hospital","city":"Nanchang","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen Memorial Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xingtai People's Hospital","city":"Xingtai","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Kunming Medical University","city":"Kunming","state":"Yunnan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Tianjin Medical University","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Tianjin Medical University","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hailong Hu, MD","phone":"+8613662096232","email":"huhailong@tmu.edu.cn"}],"primaryOutcomes":["Recurrence-free survival (RFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["nanchang-china","guangzhou-china","xingtai-china","kunming-china","shanghai-china","tianjin-china"],"enrichment":{"headline":"Not a traditional drug phase: Second Transurethral Resection of Bladder Tumor (re-TURBT) for Bladder Cancer","inPlainEnglish":"Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression. Current guidelines recommend that patients with stage T1 NMIBC undergo a second transurethral resection of bladder tumor (re-TURBT) within 2-6 weeks after the initial surgery to remove residual tumor, confirm staging, and obtain additional pathological information.","whoItsFor":["Ages 18 Years to any","Participants must meet all of the following criteria to be eligible for the study:","Male or female, aged 18 years or older","Histologically confirmed non-muscle-invasive bladder tumor, with no evidence of muscle-invasive bladder cancer or metastatic disease","Histologically confirmed urothelial carcinoma of the bladder or bladder tumor with urothelial carcinoma as the predominant component (\\>50%)","At least one of the following conditions:","Incomplete initial transurethral resection of bladder tumor (TURBT) or suspected incomplete resection","Absence of detrusor muscle in the initial TURBT pathological specimen (except for low-grade Ta stage tumors or carcinoma in situ \\[CIS\\])"],"whoShouldSkip":["Contraindications to transurethral resection of bladder tumor (TURBT)","Concurrent malignancy of the upper urinary tract (ureter or renal pelvis)"],"whatHappens":"If you join, the listed intervention(s) are Second Transurethral Resection of Bladder Tumor (re-TURBT), or utDNA Testing (Urine Tumor DNA Detection). The registry lists allocation as randomized. Non-muscle-invasive bladder cancer (NMIBC) accounts for approximately 75% of newly diagnosed bladder cancers and is characterized by a high risk of recurrence and progression.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 350 people at 7 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.317Z"},{"nctId":"NCT07187778","title":"Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)","officialTitle":"Phase II Trial of Single Agent Belzutifan or Pembrolizumab Versus Combination as Neoadjuvant Therapy in Clear Cell Renal Cell Carcinoma (BLAZE)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.","conditions":["Clear Cell Renal Cell Carcinoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Belzutifan"}],"enrollment":10,"startDate":"2025-12-19","completionDate":"2027-07-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatient must meet the following criteria to be eligible for participation in the trial:\n\n* Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC).\n\n  a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual.\n* Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading:\n\nIntermediate-high risk ccRCC\\*\n\n1. T2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0\n2. T3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\\*\n3. T4, (by radiographic criteria), any grade, N0, M0\n4. T, any stage, any grade, N+, M0 M1 RCC participants who present with the primary kidney tumor, but also solid, isolated, soft tissue metastases that are planned to be completely resected at the time of nephrectomy are eligible (e.g. metastasis to ipsilateral adrenal gland).\n\n   * NOTE: Fuhrman Tumor Grade and/or WHO/ISUP Tumor Grade are required for all subjects entering the study.\n\n     • Evaluated by urology and approved as candidates for nephrectomy.\n\n     • Age ≥18 years and consent to participation.\n\n     • Performance status of 0-1 per Zubrod/Eastern Cooperative Oncology Group \\[ECOG\\] scale.\n\n     • Absence of distant metastases on imaging of chest, abdomen and pelvis within 42 days of enrollment (by CT, MRI, or PET imaging). Brain imaging is not required unless clinical suspicion per the treating provider.\n\n     • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n\n     • Screening laboratory criteria include the following: a. ANC ≥1000, PLT ≥ 75, Hgb ≥9 (transfusion allowed if Hgb \\< 1.5 or = to upper limit of normal\n\n     • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.\n\n     • Women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (see below) prior to study entry and for the duration of study participation, including for 120 days after the last dose of pembrolizumab and 30 days after the last dose of belzutifan. WOCBP will be required to have a negative pregnancy test prior to cycle 1 day 1 of treatment, ≤24 hours prior to first dose of treatment. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n     • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of \\<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n\n     • This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n     o Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n     * History of hysterectomy or bilateral salpingo-oophorectomy.\n     * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n     * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n       • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 7 days after the last dose of study intervention:\n\n       • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent OR\n\n       • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) as detailed below:\n\n       \\- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant\n\n   Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.\n\n   \\- Male participants must also agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex.\n\n   • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   • Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of pembrolizumab and 30 days after last belzutifan administration.\n   * Ability to understand and the willingness to sign a written informed consent document.\n\n   Exclusion Criteria:\n   * Has any of the following:\n\n<!-- -->\n\n1. A pulse oximeter reading \\<92% at rest, or\n2. Requires intermittent supplemental oxygen, or\n3. Requires chronic supplemental oxygen\n\n   • Patients who have had chemotherapy or radiotherapy for RCC prior to study.\n\n   • Patients who are receiving any other investigational agents.\n\n   • History of allergic reactions attributed to compounds of similar chemical or biologic composition to belzutifan, pembrolizumab, or other agents used in study.\n\n   • Prior systemic therapy with anti-PD1, PD-L1, PD-L2, or CTLA-4 or received colony-stimulating factors (eg, G-CSF, GM-CSF or recombinant EPO) ≤28 days prior to the first dose of study intervention.\n   * Diagnosis of immunodeficiency, active autoimmune disease (per Investigator's discretion), history of pneumonitis, active infection, or known additional malignancy other than RCC.\n   * Has a known history of HIV infection. Note: Testing for HIV at screening is only required if mandated by local health authority.\n   * Has a known history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\nNote: Testing for HBV and HCV is only required if mandated by local health authority.\n\n• Patients who cannot fulfill study requirements for any reason.\n\n* Pregnant or breastfeeding women are excluded from this study because pembrolizumab is a Class-D agent with the potential for teratogenic or abortifacient effects and belzutifan has shown embryofetal toxicity in nonclinical studies\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\n  a. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are NOT excluded. Invasive cancers are allowed if treated and in complete remission for at least 3 years.\n* Has any known metastatic disease that is not planned to undergo surgical resection at the time of surgery (with the exception of ipsilateral adrenal metastases that are resectable at surgery).\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.\n* Has moderate to severe hepatic impairment (Child-Pugh B or C).\n* Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).\n* Has received prior treatment with belzutifan or another HIF-2α inhibitor.\n* Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (eg, bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.\n\nNote: A current list of strong/moderate inducers of CYP3A4 can be found at the following website:\n\nhttps://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractionstable-substrates-inhibitors-and-inducers • Has an active infection requiring systemic therapy.\n\n• Has active TB.","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas M. D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric Jonasch, MD","phone":"(713) 563-7232","email":"ejonasch@mdanderson.org"}],"primaryOutcomes":["1. Safety and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["ann-arbor-michigan","houston-texas"],"enrichment":{"headline":"Phase 2: testing Pembrolizumab for Clear Cell Renal Cell Carcinoma","inPlainEnglish":"To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.","whoItsFor":["Ages 18 Years to any","Patient must meet the following criteria to be eligible for participation in the trial:","Biopsy or archival tissue proven clear cell renal cell carcinoma (ccRCC)","a. Extra tissue should be submitted if available for correlative analysis. Formalin-fixed paraffinembedded (FFPE) tissue blocks are preferred to slides. Details pertaining to tumor tissue submission can be found in the Lab Procedures Manual","Has intermediate-high risk, high risk, or M1 ccRCC as defined by the following pathological tumor-node metastasis and tumor grading:","Intermediate-high risk ccRCC\\*","T2 (by radiographic/size criteria), Grade 4 or with sarcomatoid/rhabdoid features (on biopsy), N0, M0","T3 (presence of tumor thrombus, perinephric and/or sinus fat invastion by imaging), any grade, N0, M0 High-risk ccRCC\\*"],"whoShouldSkip":["Has any of the following:","A pulse oximeter reading \\<92% at rest, or","Requires intermittent supplemental oxygen, or","Requires chronic supplemental oxygen","Patients who have had chemotherapy or radiotherapy for RCC prior to study","Patients who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to belzutifan, pembrolizumab, or other agents used in study"],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, or Belzutifan. The registry lists allocation as randomized. To learn if belzutifan alone, pembrolizumab alone, or belzutifan and pembrolizumab in combination given before a total or partial nephrectomy (surgery to remove all or part of a kidney) can help to control locally advanced ccRCC.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 10 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.899Z"},{"nctId":"NCT07187973","title":"A Phase 1b, Open-Label Study of DISC-3405 in Participants With Sickle Cell Disease (SCD)","officialTitle":"A Phase 1b Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-3405 in Participants With Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Disc Medicine, Inc","sponsorClass":"INDUSTRY","summary":"This is an open-label, multicenter, within-participant dose-escalation study examining up to 3 dose levels of DISC-3405 and will assess the safety, tolerability, PK, and PD of DISC 3405 in participants with sickle cell disease.","conditions":["Sickle Cell Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"DISC-3405"}],"enrollment":24,"startDate":"2026-01-06","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 18 years or older at the time of signing the informed consent form (ICF).\n2. Male or female study participants with SCD HbSC or HbSS.\n3. Participants who have been diagnosed with any of the following SCD-related complications: between 1-10 episodes of VOC in the past 12 months, any history of sickle cell related retinopathy, silent cerebral infarct, avascular necrosis, sensorineural hearing loss; or at least 1 episode of priapism, hepatic sequestration, splenic sequestration, or splenic infarct within the last 12 months as assessed locally.\n4. Hgb ≥7.0 g/dL during Screening. The first 2 participants must have an Hgb ≥9 g/dL.\n5. Normal alpha globin gene screen.\n6. Absolute reticulocyte count or % reticulocyte count \\>1.5 × upper limit of normal (ULN) during Screening.\n7. TSAT ≥15% at Screening.\n8. Ferritin ≥50 ng/mL for HbSC or ≥100 ng/mL for HbSS (ferritin must be \\<1000 ng/mL at Screening).\n9. For participants taking hydroxyurea, L-glutamine, or crizanlizumab, stable dose for at least 2 months prior to Screening and with no anticipated need for dose adjustments during the study.\n10. If male, not vasectomized for at least 6 months, with female sexual partner(s) of childbearing potential, agrees he and partner will use double methods of the following highly effective methods of birth control (described below) from the first dose of randomized study drug until 120 days after the last administration of study drug and must not donate sperm during their study participation:\n\n    1. Stable hormonal contraceptive (≥3 months; female partner) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n    2. Intrauterine device, in place for at least 3 months (female partner) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n    3. Surgically sterile by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation (female partner) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n11. If female, then EITHER postmenopausal, defined as at least 12 months natural, spontaneous amenorrhea, 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) \\>40 mIU/mL at Screening, or at least 6 weeks following surgical menopause (bilateral oophorectomy with or without hysterectomy); surgically sterile, OR agree to use 1 of the following highly effective methods of birth control on Day 1 (or earlier) and for at least 120 days after the last administration of study drug:\n\n    1. Stable hormonal contraceptive (≥3 months) in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n    2. Intrauterine device, in place for at least 3 months in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n    3. Tubal ligation or single male partner with vasectomy in conjunction with a barrier method (eg, condom \\[male or female\\] or diaphragm).\n12. Negative pregnancy test (females of childbearing potential) prior to dosing.\n13. Able to understand the study aims, procedures, and requirements, and provide written informed consent.\n14. Able to comply with all study procedures.\n\nExclusion Criteria:\n\n1. Participants who are receiving regularly scheduled blood (RBC) transfusion therapy or phlebotomy or have received RBC transfusion or phlebotomy within 60 days of Screening.\n2. Hospitalized for VOC or other sickle cell related complication within 14 days of Screening.\n3. Participants with clinically significant bacterial, fungal, parasitic, or viral infection.\n4. Active HIV, hepatitis B, or C. A positive hepatitis or HIV result should be discussed between the Investigator and Sponsor prior to enrollment.\n5. Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \\<60 mL/min/1.73 m2 at the Screening visit, as assessed locally.\n6. Hepatic dysfunction characterized by alanine aminotransferase (ALT) \\>2.5 × ULN.\n7. Any episode of ACS in the last 6 months.\n8. Prior or planned hematopoietic stem cell transplant or gene therapy.\n9. History of unstable or deteriorating cardiac or pulmonary disease within 6 months prior to Screening.\n10. History of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer, or other malignancies deemed acceptable by the Sponsor.\n11. Major surgery within 8 weeks before Screening or incomplete recovery from any previous surgery.\n12. A history or known allergic reaction to any IP excipients or history of anaphylaxis to any food or drug.\n13. History of alcohol dependence or excessive alcohol consumption, as assessed by the Investigator.\n14. Other medical or psychiatric condition or laboratory finding not specifically noted above that, in the judgment of the Investigator or Sponsor, would put the participant at an unacceptable risk or otherwise preclude the participant from participating in the study.\n15. Condition or concomitant medication that would confound the ability to interpret clinical, clinical laboratory, including a major psychiatric condition that has had an exacerbation or required hospitalization in the last 6 months.\n16. If female, pregnant or breastfeeding.\n17. Participation in any other clinical protocol or investigational study that involves administration of experimental therapy and/or therapeutic devices within 30 days of Screening.\n18. Participants with a history of transient ischemic attack or stroke may be considered in consultation with Sponsor.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco (UCSF) Medical Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Hospital and Health Sciences System","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Hematology - Indiana Hemophilia & Thrombosis Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brody School of Medicine at East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center (UPMC)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Disc Medicine Clinical Trials","phone":"(617) 674 9274","email":"clinicaltrials@discmedicine.com"}],"primaryOutcomes":["Safety and tolerability of DISC-3405 administration in participants with SCD"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","san-francisco-california","atlanta-georgia","augusta-georgia","chicago-illinois","indianapolis-indiana","new-york-new-york","durham-north-carolina","greenville-north-carolina","cincinnati-ohio","pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 1: testing DISC-3405 for Sickle Cell Disease","inPlainEnglish":"This is an open-label, multicenter, within-participant dose-escalation study examining up to 3 dose levels of DISC-3405 and will assess the safety, tolerability, PK, and PD of DISC 3405 in participants with sickle cell disease.","whoItsFor":["Ages 18 Years to any","Male or female study participants with SCD HbSC or HbSS","Hgb ≥7.0 g/dL during Screening. The first 2 participants must have an Hgb ≥9 g/dL","Normal alpha globin gene screen","Absolute reticulocyte count or % reticulocyte count \\>1.5 × upper limit of normal (ULN) during Screening","TSAT ≥15% at Screening","Ferritin ≥50 ng/mL for HbSC or ≥100 ng/mL for HbSS (ferritin must be \\<1000 ng/mL at Screening)","For participants taking hydroxyurea, L-glutamine, or crizanlizumab, stable dose for at least 2 months prior to Screening and with no anticipated need for dose adjustments during the study"],"whoShouldSkip":["Participants who are receiving regularly scheduled blood (RBC) transfusion therapy or phlebotomy or have received RBC transfusion or phlebotomy within 60 days of Screening","Hospitalized for VOC or other sickle cell related complication within 14 days of Screening","Participants with clinically significant bacterial, fungal, parasitic, or viral infection","Active HIV, hepatitis B, or C. A positive hepatitis or HIV result should be discussed between the Investigator and Sponsor prior to enrollment","Significant renal dysfunction, evidenced by estimated glomerular filtration rate of \\<60 mL/min/1.73 m2 at the Screening visit, as assessed locally","Hepatic dysfunction characterized by alanine aminotransferase (ALT) \\>2.5 × ULN","Any episode of ACS in the last 6 months"],"whatHappens":"If you join, the listed intervention(s) are DISC-3405. The registry lists allocation as na. This is an open-label, multicenter, within-participant dose-escalation study examining up to 3 dose levels of DISC-3405 and will assess the safety, tolerability, PK, and PD of DISC 3405 in participants with sickle cell disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.846Z"},{"nctId":"NCT07188558","title":"A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","officialTitle":"A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19/CD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Lyell Immunopharma, Inc.","sponsorClass":"INDUSTRY","summary":"This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.","conditions":["Large B-cell Lymphoma","Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory/ Relapsed","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed"],"keywords":["Lymphoma","Non-Hodgkin Lymphoma","CAR T-Cell Therapy","CD19","CD19/CD20","Large B-cell Lymphoma"],"interventions":[{"type":"BIOLOGICAL","name":"rondecabtagene autoleucel"},{"type":"BIOLOGICAL","name":"axicabtagene ciloleucel"},{"type":"BIOLOGICAL","name":"lisocabtagene maraleucel"}],"enrollment":400,"startDate":"2026-01-12","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply","locations":[{"facility":"Banner MD Anderson Cancer Center","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Honor Health","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Arkansas","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles (UCLA)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Blood Cancer Institute","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Georgetown University Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northside Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Cancer Center","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville Health","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center (UNMC)","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Health","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of New Mexico Comprehensive Cancer Center","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Roswell Park Comprehensive Cancer Center","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Wake Forest Baptist Comprehensive Cancer Center","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oncology Hematology Care Clinical Trials","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinical Taussig Cancer Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny Health Network","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. David's South Austin Medical Center","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Transplant Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Healthcare","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University-Massey Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Townsville University Hospital","city":"Douglas","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"James Dean, MD, PhD","phone":"000-000-0000","email":"clinicaltrials@lyell.com"},{"name":"Mary Lessig, MS","phone":"000-000-0000","email":"clinicaltrials@lyell.com"}],"primaryOutcomes":["Event free survival"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["gilbert-arizona","scottsdale-arizona","little-rock-arkansas","los-angeles-california","orange-california","aurora-colorado","denver-colorado","washington-d-c-district-of-columbia","jacksonville-florida","orlando-florida","tampa-florida","atlanta-georgia","chicago-illinois","iowa-city-iowa","westwood-kansas","louisville-kentucky","boston-massachusetts","rochester-minnesota","omaha-nebraska","hackensack-new-jersey","morristown-new-jersey","albuquerque-new-mexico","buffalo-new-york","durham-north-carolina","winston-salem-north-carolina","cincinnati-ohio","cleveland-ohio","pittsburgh-pennsylvania","nashville-tennessee","austin-texas","fort-worth-texas","houston-texas","san-antonio-texas","salt-lake-city-utah","norfolk-virginia","richmond-virginia","milwaukee-wisconsin","douglas-australia","melbourne-australia","toronto-canada"],"enrichment":{"headline":"Phase 3: testing rondecabtagene autoleucel for Large B-cell Lymphoma","inPlainEnglish":"This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.","whoItsFor":["Ages 18 Years to any","CAR T cell naïve and eligible to receive a CD19 CART-cell therapy","Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)","Diffuse large B-cell lymphoma (DLBCL)","Transformations of indolent B-cell lymphomas (excluding Richter's transformation)","DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements","High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)","Primary mediastinal large B-cell lymphoma (PMBCL)"],"whoShouldSkip":["Patients ineligible to receive CD19 CAR T-cell therapy","Primary CNS lymphoma","Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation)","Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years","Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment","Active autoimmune disease requiring ongoing systemic immunosuppressive therapy","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are rondecabtagene autoleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. The registry lists allocation as randomized. This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 44 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.408Z"},{"nctId":"NCT07188766","title":"Efficacy of Liberal Versus Restricted IV Fluid Approach in the Management of Sickle Cell Vaso-Occlusive Crisis","officialTitle":"Fluid Management in Sickle Cell Disease Vaso-occlusive Crisis: Restrictive Versus Liberal Strategies: A Randomized Controlled Trial (FLASC Trial)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Imam Abdulrahman Bin Faisal University","sponsorClass":"OTHER","summary":"Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain. This study evaluates restrictive versus liberal fluid management strategies in patients with acute VOC.\n\nThis multi-center, open-label, non-inferiority RCT will enroll patients with SCD presenting with acute VOC. Participants will be randomized to either a restrictive or liberal intravenous fluid management protocol. Primary outcome is pain score reduction. Secondary outcomes include time to pain resolution, ED length of stay, hospital admission rate, cumulative opioid dose, adverse events (incidence of fluid overload, pulmonary congestion), acute chest syndrome, incidence of acute kidney injury, revisit rates within 72 hours of ED discharge, need for intensive care or high-dependency unit admission, need for additional interventions, and 28 days overall mortality. Data will be analyzed using intention-to-treat principles.\n\nWe hypothesize that a restrictive fluid strategy will achieve non-inferior pain control compared to a liberal strategy, while minimizing fluid-related complications. This study will provide evidence to inform clinical guidelines for fluid management in SCD patients experiencing VOCs.","conditions":["SCD","Vaso Occlussive Crisis"],"keywords":["sickle cell disease","sickle cell crisis","intravenous fluid","emergency department"],"interventions":[{"type":"DRUG","name":"Sodium Chloride (NaCl) 0.9 %"},{"type":"DRUG","name":"Sodium Chloride (NaCl) 0.9 %"}],"enrollment":394,"startDate":"2025-10-05","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients \\>18 years old with a confirmed diagnosis of SCD.\n2. Presenting with a VOC.\n3. NPRS \\>5\n4. Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n1. Patient requiring specialized IVF management as per the treating physician discretion.\n2. Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure\n3. Patients with ESRD on chronic dialysis\n4. Patients with signs of shock (low SBP \\<100 or MAP \\< 65) and signs of hypo perfusion\n5. Known or suspected pregnancy\n6. Previously enrolled in this trial within the last 30 days\n7. Enrolled in another trial study that interfered with fluid management\n8. Unable to obtain IV access.","locations":[{"facility":"King Fahd Hospital of the University","city":"Dammam","state":"Eastern Province","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Hopkins Aramco Healthcare","city":"Dhahran","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Fahad Military Medical Complex","city":"Dhahran","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jubail General Hospital","city":"Jubail","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Saud University Medical City","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mohammed S Alshahrani, MD","phone":"+966556966663","email":"msshahrani@iau.edu.sa"},{"name":"Laila Perlas Asonto, RN","phone":"","email":"lasonto@iau.edu.sa"}],"primaryOutcomes":["Change in Pain intensity"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["dammam-saudi-arabia","dhahran-saudi-arabia","jubail-saudi-arabia","riyadh-saudi-arabia"],"enrichment":{"headline":"Not a traditional drug phase: testing Sodium Chloride (NaCl) 0.9 % for SCD","inPlainEnglish":"Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications. Despite hydration being a cornerstone of VOC management, the optimal fluid strategy remains uncertain.","whoItsFor":["Ages 18 Years to 60 Years","Patients \\>18 years old with a confirmed diagnosis of SCD","Presenting with a VOC"],"whoShouldSkip":["Patient requiring specialized IVF management as per the treating physician discretion","Patients with congestive heart failure, and /or acute or chronic symptomatic systolic heart failure","Patients with ESRD on chronic dialysis","Patients with signs of shock (low SBP \\<100 or MAP \\< 65) and signs of hypo perfusion","Known or suspected pregnancy","Previously enrolled in this trial within the last 30 days","Enrolled in another trial study that interfered with fluid management"],"whatHappens":"If you join, the listed intervention(s) are Sodium Chloride (NaCl) 0.9 %, or Sodium Chloride (NaCl) 0.9 %. The registry lists allocation as randomized. Sickle cell disease (SCD) is a prevalent inherited blood disorder characterized by vaso-occlusive crises (VOCs), which lead to severe pain and complications.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 394 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.832Z"},{"nctId":"NCT07189325","title":"A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis","officialTitle":"A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Hospital, Montpellier","sponsorClass":"OTHER","summary":"Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades. Over the last twenty years, several disease-modifying therapies with variable benefit/risk profiles have been introduced leading to dramatic changes in the prognosis of MS.\n\nFirst, several moderately effective therapies , with good safety profile, have allowed to decrease the frequency of relapses along with a possible, albeit limited, effect on medium- and long-term disability.\n\nMore recently highly effective therapies (HET), with immunosuppressive properties, have dramatically reduced clinical and MRI disease activity and significantly improved patient's prognosis.\n\nAnti-CD20 therapies (B-cells depleting therapies, given either intravenous or subcutaneous), one of the main HET, have demonstrated higher efficacy than platform therapies in several phase 3 randomized clinical trials and their use within the very first years of the disease seems to be associated with improved long-term outcomes.\n\nTaking all of this into account, the investigators hypothesize that RRMS patients who experience a de-escalation from anti-CD20 therapies to platform therapies after 40 years will not experience disease activity accrual and disability worsening.","conditions":["Relapsing-Remitting Multiple Sclerosis (RRMS)","Anti-CD20 Therapy"],"keywords":["Multiple Sclerosis","High efficacy therapies","de-escalation","adverse events","relapses","escalation"],"interventions":[{"type":"DRUG","name":"Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons)"},{"type":"DRUG","name":"Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab)"}],"enrollment":250,"startDate":"2026-06-15","completionDate":"2031-06","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria :\n\n* Patients ≥40 years at inclusion\n* Patients with relapsing remitting multiple sclerosis at inclusion (according to 2017 McDonald criteria) treated with anti-CD20 for at least the last 3 years. For patients treated with IV ocrelizumab or rituximab at extended interval dosing, a maximum interval of 12 months between perfusions during the year before inclusion visit is required.\n* No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion)\n* Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization\n\nNon-inclusion criteria :\n\n* Secondary or primary progressive MS at inclusion\n* Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine\n* Treatment with high dose corticosteroids during the 30 days preceding inclusion\n* Contraindication to MRI\n* Severely immunocompromised state\n* Current severe active infection\n* Known active malignancy\n* Severe heart failure (New York Heart Association Class IV) or severe, uncontrolled cardiac disease\n* Severe hepatic impairment (Child-Pugh class C)\n* Significantly impaired bone marrow function or significant anaemia, leukopenia, neutropenia or thrombocytopenia\n* Severe renal impairment undergoing dialysis\n* Severe hypoproteinaemia, e.g. in nephrotic syndrome\n* Current severe depression and/or suicidal ideation\n* Suspected or confirmed progressive multifocal leukoencephalopathy (PML)\n* Any condition that, in the opinion of the investigator, would interfere with the interpretation of patient safety or place the patient at high risk for treatment-related complications\n* Participation in another therapeutic trial in the last 6 months\n* Protected population according to articles of the French Public Health Code (e.g. patients under law protection, prisoners, pregnant, parturient or lactating women, and patients under guardianship/curatorship)\n* All women of childbearing age not using effective contraception during the study\n* Subjects not covered by public health insurance\n* Failure to obtain written informed consent after a reflection period","locations":[{"facility":"Neurology Department, Hospital Gui de Chauliac","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xavier AYRIGNAC, Medical Doctor","phone":"+33 4 67 33 74 13","email":"x-ayrignac@chu-montpellier.fr"}],"primaryOutcomes":["Relapse","New/enlarged MRI lesions"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":["ocrelizumab","ofatumumab"],"locationSlugs":["montpellier-france"],"enrichment":{"headline":"Phase 3: testing Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons) for Relapsing-Remitting Multiple Sclerosis (RRMS)","inPlainEnglish":"Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost. It commonly starts during the third and fourth decades.","whoItsFor":["Ages 40 Years to any","Patients ≥40 years at inclusion","No evidence of disease activity for the last 3 years on anti-CD20 (No relapse AND no new/enlarged MRI lesion)","Brain MRI performed according to OFSEP protocol within a maximum of 6 months before randomization","Non-who can join :","Secondary or primary progressive MS at inclusion","Previous experience of treatment failure in patients treated with natalizumab, fingolimod, rituximab, ocrelizumab, mitoxantrone, alemtuzumab or cladribine","Treatment with high dose corticosteroids during the 30 days preceding inclusion"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Platform therapies (Dimethyl Fumarate, Teriflunomide, Glatiramer Acetate, Beta-interferons), or Anti-CD20 therapies (Ocrelizumab, Rituximab, Ofatumumab). The registry lists allocation as randomized. Multiple sclerosis (MS), the main central nervous system autoimmune disorder, is the first cause of non-traumatic disability in young adults and has thus significant individual consequences with elevated public health cost.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 250 people at Montpellier. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.993Z"},{"nctId":"NCT07189624","title":"Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma","officialTitle":"Effect of Acute Endurance Exercise on the Production of FGF21 and Follistatin in Patients With Hepatocellular Carcinoma","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Clermont-Ferrand","sponsorClass":"OTHER","summary":"The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known. Studying this production could help to provide relevant recommendations for training programming in these patients.","conditions":["Cirrhosis With Hepatocellular Carcinoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Exercise"}],"enrollment":12,"startDate":"2026-07-21","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Hepatocellular carcinoma developed on cirrhosis\n* Cirrhosis of any etiology, defined by a liver elasticity measurement \\>15kPa or a history of cirrhosis decompensation\n* Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization\n* Child-Pugh scores A and B7\n* WHO score ≤ 2\n* Affiliation to french national social security system\n\nExclusion Criteria:\n\n* Hepatic encephalopathy grade II or higher\n* Bone metastasis\n* Surgery performed within 30 days prior to inclusion visit\n* Liver transplant\n* Muscle injury within 3 months of inclusion\n* Pregnant or breast-feeding women\n* Patients under legal protection (guardianship, curatorship, safeguard of justice)\n* Participation in another clinical trial within 10 days of inclusion","locations":[{"facility":"Chu Estaing Medecine Digestive Et Hepatobiliaire","city":"Clermont-Ferrand","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Laclautre","phone":"0473754963","email":"promo_interne_drci@chu-clermontferrand.fr"}],"primaryOutcomes":["Systemic hepatokines rates (FGF-21 and follistatin)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["clermont-ferrand-france"],"enrichment":{"headline":"Not a traditional drug phase: Exercise for Cirrhosis With Hepatocellular Carcinoma","inPlainEnglish":"The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma. The effect of exercise on hepatokines and metabolites production in liver cancer patients is not known.","whoItsFor":["Ages 18 Years to 80 Years","Hepatocellular carcinoma developed on cirrhosis","Cirrhosis of any etiology, defined by a liver elasticity measurement \\>15kPa or a history of cirrhosis decompensation","Hepatocellular carcinoma with indication for treatment by immunotherapy or chemoembolization","Child-Pugh scores A and B7","Affiliation to french national social security system"],"whoShouldSkip":["Hepatic encephalopathy grade II or higher","Surgery performed within 30 days prior to inclusion visit","Muscle injury within 3 months of inclusion","Pregnant or breast-feeding women","Patients under legal protection (guardianship, curatorship, safeguard of justice)","Participation in another clinical trial within 10 days of inclusion"],"whatHappens":"If you join, the listed intervention(s) are Exercise. The registry lists allocation as na. The main purpose of the study is to characterize the production of hepatokines (FGF21 and Follistatin) in response to a submaximal exercise on an ergocycle, in patients with hepatocellular carcinoma.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 12 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.622Z"},{"nctId":"NCT07190248","title":"A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)","officialTitle":"A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.\n\nThe goal of this study is to learn if people who receive calderasib with SC pembrolizumab live longer without the cancer growing or spreading than in people who receive SC pembrolizumab with chemotherapy.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Calderasib"},{"type":"BIOLOGICAL","name":"Pembrolizumab (+) Berahyaluronidase alfa"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Carboplatin"}],"enrollment":675,"startDate":"2025-10-08","completionDate":"2029-12-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c\n* If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a gastrointestinal disorder affecting absorption\n* Is HIV positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy for their advanced or metastatic NSCLC\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years\n* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Has active infection requiring systemic therapy except those specified by protocol\n* Has history of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","locations":[{"facility":"Central Alabama Research ( Site 0108)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beverly Hills Cancer Center ( Site 0142)","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Connecticut Health Center ( Site 0130)","city":"Farmington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stamford Hospital ( Site 0126)","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Oncology Institute of Hope and Innovation ( Site 0161)","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Cancer Center ( Site 0137)","city":"Miami Beach","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Low Country Cancer Care ( Site 0156)","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Arnett Cancer Center ( Site 0116)","city":"Lafayette","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Cancer Specialists ( Site 0139)","city":"Westbrook","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis VA Medical Center ( Site 0145)","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0152)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Oncology Hematology, P.C. ( Site 0119)","city":"Albany","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wilmot Cancer Institute ( Site 0141)","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Charles Health System, Inc ( Site 0146)","city":"Bend","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0111)","city":"Lancaster","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology Oncology Associates of Fredericksburg ( Site 9550)","city":"Fredericksburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Cancer Institute at St. Francis ( Site 0148)","city":"Midlothian","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blue Ridge Cancer Care ( Site 0144)","city":"Roanoke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WVU Cancer Institute ( Site 0153)","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0311)","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clinicas Mar del Plata ( Site 0300)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Cordoba ( Site 0308)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEMAIC ( Site 0309)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genesis Care- Campbelltown ( Site 2907)","city":"Campbelltown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern Beaches Hospital ( Site 2905)","city":"Frenchs Forest","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Prince Charles Hospital ( Site 2903)","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Hospital Brisbane ( Site 2906)","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula & South Eastern Haematology and Oncology Group ( Site 2908)","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Klagenfurt am Wörthersee ( Site 1002)","city":"Klagenfurt","state":"Carinthia","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 1005)","city":"Graz","state":"Styria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1001)","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Algemeen Ziekenhuis Klina ( Site 3904)","city":"Brasschaat","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 3903)","city":"Genk","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"VITAZ ( Site 3902)","city":"Sint-Niklaas","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Chc Montlégia ( Site 3901)","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0412)","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Santa Rita de Cassia ( Site 0403)","city":"Vitória","state":"Espírito Santo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Real Hospital Portugues ( Site 0418)","city":"Recife","state":"Pernambuco","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa ( Site 0400)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEPEN - Centro de Pesquisa e Ensino em Oncologia de Santa Catarina ( Site 0410)","city":"Florianópolis","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto USP ( Site 0419)","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculdade de Medicina do ABC ( Site 0411)","city":"Santo André","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Alemao Oswaldo Cruz ( Site 0413)","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"IBCC - 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( Site 0808)","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Integral Internacional de Oncología ( Site 0812)","city":"Puebla City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amphia Ziekenhuis, locatie Breda Molengracht ( Site 1907)","city":"Breda","state":"North Brabant","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elisabeth-TweeSteden Ziekenhuis ( Site 1906)","city":"Tilburg","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Groningen ( Site 1908)","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht ( Site 1901)","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"IPOR Instituto Peruano de Oncología & Radioterapia ( Site 0902)","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncosalud ( Site 0901)","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nacional Edgardo Rebagliati Martins ( Site 0903)","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wojewodzki Szpital im. Sw. 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3604)","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"MacKay Memorial Hospital ( Site 3609)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Cancer Center (NTUCC) ( Site 3601)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tri-Service General Hospital ( Site 3603)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adana Medical Park Seyhan Hastanesi ( Site 2407)","city":"Seyhan","state":"Adana","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri ( Site 2400)","city":"Altindağ","state":"Ankara","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gazi Universitesi Tip Fakultesi ( Site 2404)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent Sehir Hastanesi ( Site 2401)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trakya Universitesi Tip Fakultesi ( Site 2406)","city":"Edirne","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bakirkoy Dr. Sadi Konuk Training and Research Hospital ( Site 2408)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2403)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2405)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Enterprise \"Bukovinian сlinical oncology сenter\" ( Site 2504)","city":"Chernivtsi","state":"Chernivetska Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal noncommercial enterprise of Lviv regional council \"Lviv oncological regional therapeutical ( Site 2507)","city":"Lviv","state":"Lviv Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council ( Site 2518)","city":"Odesa","state":"Odesa Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 2517)","city":"Rivne","state":"Rivne Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhytomyr Regional Oncology Center ( Site 2519)","city":"Zhytomyr","state":"Zhytomyr Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shalimov Institute of Surgery and Transplantation Oncology department ( Site 2512)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universal Clinic Oberig ( Site 2506)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Cornwall Hospital ( Site 2614)","city":"Truro","state":"Cornwall","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Free Hospital ( Site 2601)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Elizabeth Hospital Birmingham ( Site 2612)","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary ( Site 2610)","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression Free Survival (PFS) in Participants with Programmed Death-Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥1%"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["birmingham-alabama","beverly-hills-california","farmington-connecticut","stamford-connecticut","fort-lauderdale-florida","miami-beach-florida","savannah-georgia","lafayette-indiana","westbrook-maine","minneapolis-minnesota","hackensack-new-jersey","albany-new-york","rochester-new-york","bend-oregon","lancaster-pennsylvania","fredericksburg-virginia","midlothian-virginia","roanoke-virginia","morgantown-west-virginia","ciudad-aut-noma-de-buenos-aires-argentina","mar-del-plata-argentina","c-rdoba-argentina","campbelltown-australia","frenchs-forest-australia","brisbane-australia","south-brisbane-australia","frankston-australia","klagenfurt-austria","graz-austria","vienna-austria","brasschaat-belgium","genk-belgium","sint-niklaas-belgium","li-ge-belgium","fortaleza-brazil","vit-ria-brazil","recife-brazil","porto-alegre-brazil","florian-polis-brazil","ribeir-o-preto-brazil","santo-andr-brazil","s-o-paulo-brazil","edmonton-canada","toronto-canada","santiago-chile","hefei-china","beijing-china","fujian-china","fuzhou-china","guangzhou-china","nanning-china","jiamusi-china","zhengzhou-china","wuhan-china","changsha-china","nanjing-china","nanchang-china","xian-china","linyi-china","shanghai-china","taiyuan-china","chengdu-china","chongqing-china","kunming-china","hangzhou-china","taizhou-china","medell-n-colombia","bogot-colombia","marseille-france","caen-france","vand-uvre-l-s-nancy-france","pau-france","chamb-ry-france","amiens-france","paris-france","p-trai-greece","athens-greece","thessaloniki-greece","guatemala-city-guatemala","salg-tarj-n-hungary","budapest-hungary","t-r-kb-lint-hungary","beer-ya-akov-israel","jerusalem-israel","kfar-saba-israel","ramat-gan-israel","tel-aviv-israel","bolzano-italy","modena-italy","meldola-italy","udine-italy","rome-italy","bergamo-italy","rozzano-italy","statte-italy","florence-italy","catanzaro-italy","milan-italy","naples-italy","pavia-italy","verona-italy","nagoya-japan","toyoake-japan","hirosaki-japan","t-on-japan","kurume-japan","ta-japan","himeji-japan","kobe-japan","takarazuka-japan","kanazawa-japan","kawasaki-japan","yokohama-japan","matsusaka-japan","sendai-japan","hirakata-japan","sakai-japan","takatsuki-japan","ureshino-japan","bunkyo-japan","ta-ku-japan","shinjuku-japan","chiba-japan","fukuoka-japan","hiroshima-japan","kumamoto-japan","osaka-japan","johor-bahru-malaysia","wilayah-persekutuan-malaysia","kuantan-malaysia","george-town-malaysia","kota-kinabalu-malaysia","kuching-malaysia","petaling-jaya-malaysia","kuala-lumpur-malaysia","guadalajara-mexico","benito-ju-rez-mexico","monterrey-mexico","oaxaca-city-mexico","chihuahua-city-mexico","mexico-city-mexico","puebla-city-mexico","breda-netherlands","tilburg-netherlands","groningen-netherlands","utrecht-netherlands","lima-peru","przemy-l-poland","gliwice-poland","olsztyn-poland","bucharest-romania","cluj-napoca-romania","flore-ti-romania","craiova-romania","ploie-ti-romania","brasov-romania","jeollanam-do-south-korea","yangsan-south-korea","busan-south-korea","daejeon-south-korea","seoul-south-korea","badalona-spain","barcelona-spain","a-coru-a-spain","majadahonda-spain","valencia-spain","madrid-spain","seville-spain","zurich-switzerland","chiayi-city-taiwan","new-taipei-city-taiwan","tainan-taiwan","taipei-taiwan","seyhan-turkey-t-rkiye","altinda-turkey-t-rkiye","ankara-turkey-t-rkiye","edirne-turkey-t-rkiye","istanbul-turkey-t-rkiye","chernivtsi-ukraine","lviv-ukraine","odesa-ukraine","rivne-ukraine","zhytomyr-ukraine","kyiv-ukraine","truro-united-kingdom","london-united-kingdom","birmingham-united-kingdom","leicester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Calderasib for Non-small Cell Lung Cancer","inPlainEnglish":"Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together. Calderasib is a targeted therapy for the KRAS G12C mutation.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has nonsquamous NSCLC (Stage IIIB, Stage IIIC) not eligible for curative resection or chemoradiation or Stage IV: M1a, M1b, or M1c","If human immunodeficiency virus (HIV) positive, must have well controlled HIV on antiretroviral therapy (ART)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Calderasib, Pembrolizumab (+) Berahyaluronidase alfa, or Pemetrexed. The registry lists allocation as randomized. Researchers want to learn if the study medicines calderasib and subcutaneous (SC) pembrolizumab can be used to treat non-small cell lung cancer (NSCLC) when given together.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 675 people at 225 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.709Z"},{"nctId":"NCT07191145","title":"Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT)","officialTitle":"EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sunnybrook Health Sciences Centre","sponsorClass":"OTHER","summary":"Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH. Patients with migraine-PTH are at greater risk of persistent symptoms whereby the acute PTH (aPTH) becomes persistent PTH (pPTH) (ie. lasting \\> 3 months) with a conversion rate of 47-95%. As migraine symptoms become chronic, it becomes treatment resistant. Despite these implications, early preventive medication management of PTH is marred by lengthy trials of multiple medications (2-3 months for each) and adverse effects that aggravate mTBI symptoms (fatigue, nausea, and presyncope). There is a compelling need to establish an effective treatment to prevent this debilitating outcome. Eptinezumab is a calcitonin gene-related peptide (CGRP)-blocking monoclonal antibody that reduces migraine burden in patients with migraines after a single infusion. Patients with PTH have higher serum levels of CGRP and experimental infusion of CGRP to patients with mTBI reproduces migraine PTH symptoms. Given the similarly in CGRP expression between chronic migraines and PTH, an infusion of eptinezumab within 8 weeks of PTH is hypothesized to reduce headache burden 3 months after treatment and prevent pPTH.","conditions":["Post Traumatic Headache"],"keywords":["Migraine"],"interventions":[{"type":"DRUG","name":"Eptinezumab"},{"type":"OTHER","name":"Placebo"}],"enrollment":80,"startDate":"2026-11","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meet diagnostic criteria for acute post-traumatic headache as per ICHD-3 criteria\n* Meet migraine screening questionnaire criteria (MSQ score ≥ 4) during at least one of the weekly screening calls\n* Within 8 weeks after onset of PTH\n\n  \\* Imaging is not required for inclusion\n* Negative human chorionic gonadotropin test before treatment, for female participants of childbearing potential who are not practicing medically appropriate methods of birth control (e.g., hormonal contraceptives, implants, injectables, intrauterine devices, intrauterine systems, etc.)\n\nExclusion Criteria:\n\n* Diagnosis of moderate to severe TBI\n* History of mTBI within the past 5 years\n* Pre-existing chronic migraine and its subtypes, tension-type headache, trigeminal autonomic cephalalgias, cranial neuralgias, daily headache, diagnosis of another secondary headache disorder per ICHD-3 (except medication overuse headache)\n* Concurrent use of CGRP-related treatment or botulinum toxin within the last three month for migraine\n* Substance / opioids use disorder\n* Confounding chronic pain disorder / clinically significant pains\n* Concurrent major injuries (long bone, rib, and spinal fractures) or surgical intervention while in hospital on initial trauma\n* On-going litigation for current trauma\n* Pregnancy/breast-feeding\n* Uncontrolled psychiatric conditions (depression, PTSD, anxiety, functional neurological disorder)\n* Use of opioids/barbiturates for headaches (\\> 4 days/month)\n* Hereditary fructose intolerance","locations":[{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Howard Meng, MD","phone":"416-480-4864","email":"howard.meng@sunnybrook.ca"},{"name":"Lavarnan Sivanathan, MD","phone":"","email":"lavarnan.sivanathan@sunnybrook.ca"}],"primaryOutcomes":["Headache frequency"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 3: testing Eptinezumab for Post Traumatic Headache","inPlainEnglish":"Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH). Of PTH, 50% present with a migraine phenotype which is the most disabling type of PTH.","whoItsFor":["Ages 18 Years to 65 Years","Meet diagnostic criteria for acute post-traumatic headache as per ICHD-3 criteria","Meet migraine screening questionnaire criteria (MSQ score ≥ 4) during at least one of the weekly screening calls","Within 8 weeks after onset of PTH","\\* Imaging is not required for inclusion"],"whoShouldSkip":["Diagnosis of moderate to severe TBI","History of mTBI within the past 5 years","Pre-existing chronic migraine and its subtypes, tension-type headache, trigeminal autonomic cephalalgias, cranial neuralgias, daily headache, diagnosis of another secondary headache disorder per ICHD-3 (except medication overuse headache)","Concurrent use of CGRP-related treatment or botulinum toxin within the last three month for migraine","Substance / opioids use disorder","Confounding chronic pain disorder / clinically significant pains","Concurrent major injuries (long bone, rib, and spinal fractures) or surgical intervention while in hospital on initial trauma"],"whatHappens":"If you join, the listed intervention(s) are Eptinezumab, or Placebo. The registry lists allocation as randomized. Most individuals with mild traumatic brain injury (mTBI) experience post-traumatic headaches (PTH).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 80 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.298Z"},{"nctId":"NCT07195344","title":"Study Aiming to Compare the Plasma Exposure of the Payload (Free-DXd) in Patients Treated by T-DXd for Locally Advanced or Metastatic Breast Cancer According to Their BMI.","officialTitle":"Influence of Patient's Morphological Characteristics on Pharmacokinetic and Toxicity of Trastuzumab-Deruxtecan Administered for Metastatic Breast Cancers","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institut Claudius Regaud","sponsorClass":"OTHER","summary":"This is a multicenter, prospective, non-randomized, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their BMI.\n\nThe primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (BMI\\>25) and normal weight (BMI≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).\n\nA total of 210 patients will have to be enrolled in this study with the following repartition:\n\nN = 105 patients with a BMI ≤ 25 (normal weight patients). N = 105 patients with a BMI \\> 25 (overweight or obese patients) with at least 30 obese patients (BMI\\>30).","conditions":["Locally Advanced or Metastatic Breast Cancers"],"keywords":["Locally or metastatic Breast Cancer","HER2 low-expressed","HER2 over-expressed/amplified","Trastuzumab-Deruxtecan","Body Mass Index","Pharmacokinetics"],"interventions":[{"type":"BIOLOGICAL","name":"Pharmacokinetics blood samples"}],"enrollment":210,"startDate":"2025-10-15","completionDate":"2029-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Women (or men) aged ≥ 18 years on the day of signing the informed consent with histologically proven breast cancer.\n2. Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval).\n3. Patient eligible for Trastuzumab-Deruxtecan (T-DXd).\n4. Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer.\n5. Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment.\n6. Female subjects of childbearing potential must be willing to follow at least one method of contraception or be surgically sterile, or abstain from heterosexual activity for the duration of the study and until 7 months after the last dose of study treatment. Subjects of childbearing potential are those who have not been surgically sterilized and who had menstruation in the last 12 months.\n\n   Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n7. Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment.\n\n   Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception.\n8. Signed written informed consent.\n9. Patient able to participate and willing to give informed consent prior performance of any study-related procedures and to comply with the study protocol.\n10. Patient affiliated to a Social Health Insurance in France.\n\nExclusion Criteria:\n\n1. Peripheral venous access making blood samples difficult.\n2. Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)\n3. Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n4. Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.\n5. Patient pregnant, or breast-feeding.\n6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.\n7. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).\n8. Concurrent participation in an experimental drug study.\n9. Patient with a known history of hypersensitivity to the active substance of T-DXd or to any of the excipients listed in the SmPC of T-DXd.\n10. Patient with severe hepatic impairment defined by TGO and/or TGP \\> 5 x ULN and Total bilirubin \\> 1.5 x ULN.","locations":[{"facility":"Institut de Cancérologie de l'Ouest - Site Angers","city":"Angers","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Georges François Leclerc","city":"Dijon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Oscar Lambret","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli Calmettes","city":"Marseille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nîmes","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie - Site Paris","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugène Marquis","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Paul Strauss","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"IUCT-O","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancérologie de Lorraine","city":"Vandœuvre-lès-Nancy","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Florence DALENC, MD, Prof","phone":"+33531155104","email":"dalenc.florence@iuct-oncopole.fr"}],"primaryOutcomes":["Primary Outcome Measure"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["angers-france","dijon-france","lille-france","marseille-france","n-mes-france","paris-france","rennes-france","strasbourg-france","toulouse-france","vand-uvre-l-s-nancy-france"],"enrichment":{"headline":"Phase 4: testing Pharmacokinetics blood samples for Locally Advanced or Metastatic Breast Cancers","inPlainEnglish":"This is a multicenter, prospective, non-randomly assigned, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their body-mass index (BMI). The primary objective is to compare plasma exposition of the payload (free-DXd) between overweight or obese (body-mass index (BMI)\\>25) and normal weight (body-mass index (BMI)≤25) breast cancer patients during the first 3 cycles of Trastuzumab-Deruxtecan (T-DXd).","whoItsFor":["Ages 18 Years to any","Metastatic or locally advanced breast cancer with overexpression/amplification HER2 (IHC +++ or ++ and positive-hybridation in situ) or low HER2 expression (IHC + or ++ and negative-hybridation in situ) and may be ultra-low (in first line, in case of approval)","Patient eligible for Trastuzumab-Deruxtecan (T-DXd)","Concomitant administration of pertuzumab may be accepted in case of approval in first line for HER2- overexpressed/amplified locally advanced or metastatic breast cancer","Female subjects of childbearing potential must have a negative pregnancy test within 72 hours prior to receiving the first dose of study treatment","Note: Abstinence is acceptable if it is the subject's usual lifestyle and preferred method of contraception","Male subjects must agree to use at least one method of contraception for the duration of the study and until 4 months after the last dose of study treatment","Patient affiliated to a Social Health Insurance in France"],"whoShouldSkip":["Peripheral venous access making blood samples difficult","Patients unable to receive T-DXd treatment at a dose of 5.4 mg/kg in cycle 1 (whatever the reason)","Patients with known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer","Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study","Patient pregnant, or breast-feeding","Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)","Concurrent participation in an experimental drug study"],"whatHappens":"If you join, the listed intervention(s) are Pharmacokinetics blood samples. The registry lists allocation as na. This is a multicenter, prospective, non-randomly assigned, open-label, pharmacokinetic study, aiming to compare the plasma exposure of the payload (free-DXd) in patients treated by T-DXd for locally advanced or metastatic breast cancer according to their body-mass index (BMI).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 210 people at 10 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.368Z"},{"nctId":"NCT07195591","title":"Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care","officialTitle":"Randomized Study of Resection and GammaTile® Followed by Concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ) and Adjuvant TMZ Versus Standard of Care in Newly Diagnosed Glioblastoma (GBM)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"GT Medical Technologies, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 3 prospective, randomized, superiority, open-label, multi-site study. The overview of this study is as follows:\n\n* A Screening/Baseline Period of 21 days. During this time, patients will be randomized into a 1:2 allocation of Arm A:Arm B.\n* A Perioperative/Operative Phase where patients will undergo tumor resection (Arm A) or tumor resection plus GammaTile implantation (Arm B).\n* An EBRT Prior to Start Period. This occurs within 10 business days prior to EBRT and Concurrent TMZ Phase.\n* An EBRT and Concurrent TMZ Phase, which will begin 30 ±10 days post-surgery. EBRT (30 fractions) and TMZ will be administered up to 5 days a week for 6 weeks in Arm A, and EBRT (20 fractions) and TMZ will be administered for up to 5 days a week for 4 weeks in Arm B. TMZ will be administered at a dose of 75 mg/m2/day orally for each Arm.\n* An Adjuvant TMZ Phase, which begins 28 ±7 days following the EBRT and Concurrent TMZ Phase, and is comprised of six 28-day cycles. TMZ (150-200 mg/m2/day orally) will be administered for the first 5 days of each 28-day cycle for each Arm. Tumor treating fields are allowed but are not mandated during this phase. Up to 6 additional cycles (for a total of 12) can be completed at the discretion of the Investigator.\n* An Early Discontinuation/Follow-Up Phase will occur 28 ±7 days after completion of Cycle 6 of the Adjuvant TMZ Phase, regardless of the total number of cycles completed or any delays in cycle start. If fewer than six cycles are completed, the first follow-up assessment will occur 28 ±7 days after the last administered dose of adjuvant TMZ. If patient has a qualifying event requiring entrance to Early Discontinuation Phase, the first follow-up assessment will occur as soon as feasible, but within 28 days.\n\nFor any unscheduled visits, data collected should be documented in the case report form (CRF) and must include, but are not limited to, safety evaluations, survival status, and disease status.","conditions":["Glioblastoma"],"keywords":["Glioblastoma","Newly Diagnosed","GammaTile","External Beam Radiation Therapy","Temozolomide","Brain","Tumor","Brachytherapy","Radiation Therapy","Surgery","Resection","GBM","BRIDGES","EBRT","TMZ"],"interventions":[{"type":"DEVICE","name":"GammaTile®"},{"type":"RADIATION","name":"External Beam Radiation Therapy"},{"type":"DRUG","name":"Temozolomide"}],"enrollment":766,"startDate":"2025-12-10","completionDate":"2031-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Major Criteria Includes the Following:\n\nInclusion Criteria\n\n* Patients must be ≥18 years of age.\n* Have radiographic suspicion of newly diagnosed glioblastoma (GBM).\n\n  o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and efficacy analyses.\n* Are medically and surgically appropriate for resection.\n* Have an estimated Karnofsky Performance Scale (KPS) score of ≥70.\n* Are able to receive standard of care treatment.\n\nExclusion Criteria\n\n* A previous biopsy diagnosis other than IDH wild-type GBM.\n* Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography.\n* Have multi-focal enhancing tumors that cannot be encompassed in one operative field.","locations":[{"facility":"HonorHealth Scottsdale Osborn Medical Center","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Medicine of USC","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Fransico","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advent Health - Colorado","city":"Littleton","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advent Health","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Cancer Institute - Brownsboro","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Missouri","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth Hitchcock Medical Center","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jersey Shore University Medical Center | Hackensack","city":"Neptune City","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westchester Medical Center","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allegheny Health Network","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brown University Health","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kimberly Johnson","phone":"(833)662-0044","email":"kjohnson@gammatile.com"}],"primaryOutcomes":["Overall Survival"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","los-angeles-california","san-francisco-california","littleton-colorado","orlando-florida","atlanta-georgia","chicago-illinois","louisville-kentucky","baltimore-maryland","columbia-missouri","lebanon-new-hampshire","neptune-city-new-jersey","valhalla-new-york","greenville-north-carolina","columbus-ohio","pittsburgh-pennsylvania","providence-rhode-island","charleston-south-carolina","houston-texas","fairfax-virginia"],"enrichment":{"headline":"Phase 3: testing Temozolomide for Glioblastoma","inPlainEnglish":"This is a Phase 3 prospective, randomly assigned, superiority, open-label, multi-site study. The overview of this study is as follows: * A Screening/Baseline Period of 21 days.","whoItsFor":["Ages 18 Years to any","Major Criteria Includes the Following:","Patients must be ≥18 years of age","Have radiographic suspicion of newly diagnosed glioblastoma (GBM)","o If final pathology reports IDH mutant glioma, then the patients found to have an IDH mutation will be followed for safety and QoL measures but will not be included in the primary and secondary comparative survival and how well it works analyses","Are medically and surgically appropriate for resection","Have an estimated Karnofsky Performance Scale (KPS) score of ≥70","Are able to receive standard of care treatment"],"whoShouldSkip":["A previous biopsy diagnosis other than IDH wild-type GBM","Have contraindications to TMZ, magnetic resonance imaging, gadolinium, or non-contrast computed tomography","Have multi-focal enhancing tumors that cannot be encompassed in one operative field"],"whatHappens":"If you join, the listed intervention(s) are GammaTile®, External Beam Radiation Therapy, or Temozolomide. The registry lists allocation as randomized. This is a Phase 3 prospective, randomly assigned, superiority, open-label, multi-site study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 766 people at 22 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.472Z"},{"nctId":"NCT07195695","title":"Beamion LUNG-3: Adjuvant Zongertinib vs Standard Treatment in People With Completely Resected Stage II-IIIB NSCLC Harboring Activating HER2 TKD Mutations","officialTitle":"Beamion LUNG-3: A Randomized, Controlled, Multi-center Trial Evaluating Zongertinib as an Adjuvant Monotherapy Compared With Standard of Care in Patients With Early-stage, Resectable Non-small Cell Lung Cancer (Stage II-IIIB) Harboring Tyrosine Kinase Domain Activating HER2 Mutations","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.\n\nParticipants are randomized 1:1 to receive zongertinib or standard of care, which may consist of approved adjuvant immunotherapy or active surveillance, based on local practice guidelines. The main purpose of the study is to determine whether zongertinib can prolong disease-free survival compared to standard treatment. Safety and patient-reported outcomes are also assessed.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Zongertinib"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Atezolizumab"},{"type":"DRUG","name":"Durvalumab"},{"type":"DRUG","name":"Nivolumab"}],"enrollment":400,"startDate":"2026-01-16","completionDate":"2032-02-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n2. Patients must be ≥18 years old or over the legal age of consent in their country\n3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use dual highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the study protocol\n4. HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations\n5. Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC\n6. An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status\n7. Staging: Pretherapeutic classification not exceeding Stage IIIB\n8. Performance status and organ function:\n\n   * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n   * Adequate organ function based on laboratory values Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)\n2. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization\n3. Treatment with radiation therapy for primary NSCLC\n4. Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))\n5. Any investigational drug within 5 half-lives of the compound or any of its related material, if known\n6. History or presence of\n\n   * Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis\n   * Active infectious disease requiring systemic therapy\n   * Uncontrolled gastrointestinal disorders affecting drug intake/absorption\n   * Previous or concomitant malignancies within the last 3 years, except certain effectively treated cancers\n   * Significant and/or uncontrolled cardiovascular abnormalities, QT interval corrected for heart rate by Fridericia formula (QTcF) \\>470 msec, or ejection fraction \\<50% Further exclusion criteria apply.","locations":[{"facility":"ClinRé 001-022 (Premier Cancer Care and Infusion Center)","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OPN Healthcare, Inc.","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarcoma Oncology Center","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern California Kaiser Permanente","city":"Vallejo","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"George Washington University Cancer Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mid Florida Hematology and Oncology Center","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Georgia Oncology Centers","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Alphonsus Regional Medical Center - 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3: testing Zongertinib for Non-small Cell Lung Cancer","inPlainEnglish":"Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations. Eligible participants must have undergone curative-intent surgery and received guideline-appropriate perioperative systemic therapy, either neoadjuvant platinum-based chemotherapy with or without immunotherapy, or adjuvant platinum-based chemotherapy.","whoItsFor":["Ages 18 Years to any","Patients must be ≥18 years old or over the legal age of consent in their country","HER2 mutation: Documented Tyrosine kinase domain (TKD) activating Human epidermal growth factor receptor 2 (HER2) mutations","Histology and tumor sample: Histologically confirmed diagnosis of primary NSCLC","An archival tumor tissue sample must be submitted to the central laboratory after inclusion of the patient to retrospectively confirm the HER2 status","Staging: Pretherapeutic classification not exceeding Stage IIIB","Performance status and organ function:","Eastern Cooperative Oncology Group (ECOG) score of 0 or 1"],"whoShouldSkip":["Diagnosis of NSCLC with mixed histology/positive neuroendocrine markers (synaptophysin/CD56)","Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization","Treatment with radiation therapy for primary NSCLC","Co-occurring actionable mutation with approved targeted therapy (e.g. Epidermal growth factor receptor (EGFR) or Anaplastic lymphoma kinase (ALK))","Any investigational drug within 5 half-lives of the compound or any of its related material, if known","History or presence of","Active or known pre-existing or history of non-infectious interstitial lung disease/pneumonitis"],"whatHappens":"If you join, the listed intervention(s) are Zongertinib, Pembrolizumab, or Atezolizumab. The registry lists allocation as randomized. Beamion LUNG-3 study evaluates whether zongertinib, an oral HER2-targeted treatment, can improve outcomes compared with standard adjuvant treatment in adults with completely resected Stage II-IIIB non-small cell lung cancer (NSCLC) whose tumors have activating HER2 tyrosine kinase domain (TKD) mutations.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 203 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.013Z"},{"nctId":"NCT07196332","title":"Recovering Sleep After Trauma","officialTitle":"Recovering Sleep After Trauma","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of North Carolina, Chapel Hill","sponsorClass":"OTHER","summary":"The main objective of this pilot trial is to assess the feasibility and preliminary efficacy of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.","conditions":["Post-traumatic Stress Disorder"],"keywords":["Trauma and Stressor Related Disorders","Mental Disorders","Stress Disorders, Traumatic","Stress Disorders, Post-Traumatic","Motor Vehicle Collision"],"interventions":[{"type":"BEHAVIORAL","name":"Brief Behavioral Treatment for Insomnia (BBTI)"},{"type":"BEHAVIORAL","name":"Progressive Muscle Relaxation Training (PMRT)"}],"enrollment":20,"startDate":"2026-04-30","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Alert and oriented at time of screening\n2. Written and spoken English\n3. Age 18-65\n4. Presents to the ED within 72 hours of MVC\n5. Discharged home after ED evaluation\n6. Has an email and mailing address\n7. Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year\n8. Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)\n9. Willing to participate in four remote therapy sessions\n\nExclusion Criteria:\n\n1. Age \\<18 or \\>65\n2. Pregnant\n3. Prisoner or in police custody\n4. Present to ED \\>72 hours after trauma\n5. Admitted to the hospital after ED evaluation\n6. Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories\n7. Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment\n8. Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)\n9. MVC was self-inflicted or occupation-related\n10. Report or indicate that they are experiencing ongoing domestic violence\n11. Has conditions that may be associated with comorbid insomnia, including a lifetime history of any psychiatric disorder with psychotic features, manic or hypomanic episodes. We will not exclude individuals based on any other mental health condition, including depression","locations":[{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrea A Massa, PhD","phone":"(919) 966-1644","email":"REST@unc.edu"},{"name":"Romina Soudavari, MPH","phone":"(919) 966-1644","email":"REST@unc.edu"}],"primaryOutcomes":["Changes in PTSD Symptom Severity Over Time","Recruitment Rates","Retention Rates","Treatment Completion Rates"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Brief Behavioral Treatment for Insomnia (BBTI) for Post-traumatic Stress Disorder","inPlainEnglish":"The main objective of this pilot trial is to assess the feasibility and preliminary how well it works of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk. This pilot trial will provide the data necessary to design and support a large-scale trial.","whoItsFor":["Ages 18 Years to 65 Years","Alert and oriented at time of screening","Written and spoken English","Presents to the ED within 72 hours of MVC","Discharged home after ED evaluation","Has an email and mailing address","Owns a smartphone compatible with iOS or Android, has not experienced service interruption due to non-payment in the past year, and has maintained the same phone number for at least one year","Meets PTSD risk score criteria (score of ≥ 16 on the PTSD risk stratification tool)"],"whoShouldSkip":["Prisoner or in police custody","Present to ED \\>72 hours after trauma","Admitted to the hospital after ED evaluation","Severely injured (e.g., severely broken bones) as a result of the MVC that, in the opinion of the investigator, may impact PTSD trajectories","Had a change in psychiatric medication or psychotherapy regimen within 1 month of enrollment","Currently receiving or planning to receive evidence-based treatments that directly target insomnia or PTSD (e.g., CBT-I, Cognitive Processing Therapy, or Prolonged Exposure Therapy)","MVC was self-inflicted or occupation-related"],"whatHappens":"If you join, the listed intervention(s) are Brief Behavioral Treatment for Insomnia (BBTI), or Progressive Muscle Relaxation Training (PMRT). The registry lists allocation as randomized. The main objective of this pilot trial is to assess the feasibility and preliminary how well it works of telehealth-delivered behavioral therapy to reduce the development of posttraumatic stress and depressive symptoms following motor vehicle collision among individuals at high risk.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Chapel Hill. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.411Z"},{"nctId":"NCT07196722","title":"A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase 2b/3 Randomized, Double-blind, Placebo-Controlled, Parallel Group, Multicenter Protocol to Evaluate the Efficacy and Safety of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).","conditions":["Crohn Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Icotrokinra"},{"type":"DRUG","name":"Placebo"}],"enrollment":1092,"startDate":"2025-10-03","completionDate":"2028-09-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \\>=220 but \\<=450 and either mean daily SF count \\>=4, or mean daily AP score \\>=2\n* Moderately to severely active CD based on SES-CD criteria assessed by baseline (Week I-0) endoscopic evidence of active ileal and/or colonic CD as assessed during central review of the screening video ileocolonoscopy defined as a SES-CD \\>= 6 for participants with colonic or ileocolonic disease, and SES-CD \\>= 4 for participants with isolated ileal disease, based on the presence of ulceration in any 1 of the 5 ileocolonic segments\n* A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests\n* Demonstrated an inadequate response to, or failure to tolerate conventional therapy but naïve to advanced therapies (advanced drug therapy \\[ADT\\]-naïve) or inadequate response to (that is, primary or secondary nonresponse) or failure to tolerate advanced therapy defined as biologics and/or advanced oral agents for the treatment of CD- (ADT-inadequate responder \\[IR\\]) as defined in the protocol\n\nExclusion criteria:\n\n* Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention\n* Presence of a stoma or ostomy\n* Participants with presence of active fistulas may be included if there is no surgery needed\n* Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline\n* Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization","locations":[{"facility":"AZ Gastro Care","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Solutions of Arizona","city":"Litchfield Park","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinnova Research","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Research Institute, LLC - Canoga Park","city":"Canoga Park","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research, 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Endpoint)"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["chandler-arizona","litchfield-park-arizona","scottsdale-arizona","anaheim-california","canoga-park-california","coronado-california","lancaster-california","los-angeles-california","newport-beach-california","oxnard-california","san-diego-california","san-francisco-california","colorado-springs-colorado","danbury-connecticut","cutler-bay-florida","inverness-florida","jacksonville-florida","lakewood-rch-florida","miami-florida","tampa-florida","atlanta-georgia","macon-georgia","indianapolis-indiana","wichita-kansas","crestview-hills-kentucky","louisville-kentucky","lafayette-louisiana","west-monroe-louisiana","chevy-chase-maryland","glen-burnie-maryland","rochester-minnesota","carmel-new-york","new-york-new-york","chapel-hill-north-carolina","charlotte-north-carolina","oklahoma-city-oklahoma","portland-oregon","harrisburg-pennsylvania","hershey-pennsylvania","philadelphia-pennsylvania","providence-rhode-island","charleston-south-carolina","rock-hill-south-carolina","austin-texas","carrollton-texas","dallas-texas","houston-texas","san-antonio-texas","southlake-texas","tyler-texas","chesapeake-virginia","lynchburg-virginia","tacoma-washington","milwaukee-wisconsin","aai-argentina","buenos-aires-argentina","caba-argentina","c-rdoba-argentina","maipu-argentina","mendoza-argentina","adelaide-australia","clayton-australia","concord-australia","fitzroy-australia","murdoch-australia","new-lambton-heights-australia","south-brisbane-australia","brussels-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","ostend-belgium","tournai-belgium","belo-horizonte-brazil","botucatu-brazil","bras-lia-brazil","curitiba-brazil","fortaleza-brazil","ja-brazil","juiz-de-fora-brazil","maca-brazil","natal-brazil","niter-i-brazil","porto-alegre-brazil","recife-brazil","ribeir-o-preto-brazil","salvador-brazil","santo-andr-brazil","santos-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","votuporanga-brazil","edmonton-canada","vancouver-canada","kentville-canada","barrie-canada","london-canada","oakville-canada","toronto-canada","montreal-canada","beijing-china","changsha-china","changzhou-china","chengdu-china","chongqing-china","foshan-china","fuzhou-china","guangzhou-china","haikou-china","hangzhou-china","hefei-china","huizhou-china","jinhua-china","lanzhou-china","luoyang-china","luzhou-china","nanjing-china","nanning-china","ningbo-china","shanghai-china","shenyang-china","shenzhen-china","suzhou-china","wenzhou-china","wuhan-china","xiamen-china","yangzhou-china","zhuzhou-china","zunyi-china","brno-czechia","kladno-czechia","olomouc-czechia","pardubice-czechia","prague-czechia","praha-1-mala-strana-czechia","p-erov-czechia","bayonne-france","clermont-ferrand-france","cr-teil-france","chirolles-france","lille-france","montfermeil-france","montpellier-france","nantes-france","nice-france","paris-france","pierre-b-nite-france","saint-priest-en-jarez-france","toulouse-france","vand-uvre-l-s-nancy-france","berlin-germany","dachau-germany","erlangen-germany","halle-germany","hanover-germany","jerichow-germany","kiel-germany","leipzig-germany","l-beck-germany","l-neburg-germany","rostock-germany","ulm-germany","athens-greece","heraklion-greece","nikaia-greece","piraeus-greece","thessaloniki-greece","b-k-scsaba-hungary","budapest-hungary","debrecen-hungary","szeged-hungary","szeksz-rd-hungary","tatab-nya-hungary","bangalore-india","bengaluru-india","bhubaneswar-india","gurugram-india","hyderabad-india","jaipur-india","kochi-india","ludhiana-india","mumbai-india","new-delhi-india","patna-india","secunderabad-india","surat-india","afula-israel","ashdod-israel","beer-ya-aqov-israel","haifa-israel","jerusalem-israel","nahariya-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","cagliari-italy","milan-italy","monza-italy","negrar-verona-italy","roma-italy","rozzano-italy","torino-italy","chiba-japan","fukui-shi-japan","gamag-ri-japan","hamamatsu-japan","higashiibaraki-gun-japan","hiroshima-japan","kagawa-japan","kagoshima-japan","kanazawa-japan","kashiwa-japan","kawagoe-japan","kitakyushu-japan","kumamoto-japan","kurume-japan","mitaka-japan","miyagi-japan","nagakute-japan","nagasaki-japan","nishinomiya-shi-japan","okinawa-japan","osaka-japan","saga-japan","sakura-japan","sapporo-japan","sendai-japan","shinjuku-ku-japan","sunto-gun-japan","alor-star-malaysia","ampang-malaysia","johor-bahru-malaysia","kuala-lumpur-malaysia","kuantan-malaysia","seremban-malaysia","amsterdam-netherlands","maastricht-netherlands","nijmegen-netherlands","rotterdam-netherlands","bydgoszcz-poland","krakow-poland","lublin-poland","nowy-targ-poland","olsztyn-poland","opole-poland","poznan-poland","rzesz-w-poland","sopot-poland","szczecin-poland","torun-poland","warsaw-poland","wroclaw-poland","zamo-poland","braga-portugal","guimar-es-portugal","lisbon-portugal","loures-portugal","porto-portugal","bucharest-romania","cluj-napoca-romania","constan-a-romania","sibiu-romania","busan-south-korea","daegu-south-korea","daejeon-south-korea","dongdaemun-gu-south-korea","seongnam-si-south-korea","seoul-south-korea","suwon-south-korea","barcelona-spain","gij-n-spain","girona-spain","madrid-spain","santiago-de-compostela-spain","seville-spain","valencia-spain","allingsas-sweden","gothenburg-sweden","link-ping-sweden","rebro-sweden","stockholm-sweden","uppsala-sweden","bern-switzerland","sankt-gallen-switzerland","changhua-taiwan","kaohsiung-city-taiwan","taipei-taiwan","taoyuan-taiwan","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","bursa-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","kocaeli-turkey-t-rkiye","mersin-turkey-t-rkiye","birmingham-united-kingdom","cambridge-united-kingdom","glasgow-united-kingdom","greater-manchester-united-kingdom","london-united-kingdom","rainhill-united-kingdom","stockport-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Icotrokinra for Crohn Disease","inPlainEnglish":"This study wants to evaluate how-well icotrokinra works (clinical how well it works) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).","whoItsFor":["Ages 18 Years to any","Diagnosis of CD established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD","Moderately to severely active CD based on CDAI criteria, defined as baseline (Week I-0) CDAI score \\>=220 but \\<=450 and either mean daily SF count \\>=4, or mean daily AP score \\>=2","A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta-hCG) at screening and a negative urine pregnancy test at Week I-0 prior to administration of study intervention and agree to further pregnancy tests"],"whoShouldSkip":["Has complications of CD, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation, that may require surgery while enrolled in the study and/or could impair the use of instruments (such as CDAI) to assess response to study intervention","Presence of a stoma or ostomy","Participants with presence of active fistulas may be included if there is no surgery needed","Colonic resection within 24 weeks before baseline or any other major surgery performed within 12 weeks before baseline","Presence on screening colonoscopy of adenomatous colon polyps outside of an area of known colitis not removed before randomization"],"whatHappens":"If you join, the listed intervention(s) are Icotrokinra, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how-well icotrokinra works (clinical how well it works) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 1,092 people at 395 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.898Z"},{"nctId":"NCT07197138","title":"IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition","officialTitle":"Pilot Study on the Effects of Intensified Repetitive Transcranial Magnetic Stimulation on Immunological Blood Parameters in Patients With Depression and Comorbid Post-COVID-19 Condition","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Max-Planck-Institute of Psychiatry","sponsorClass":"OTHER","summary":"This is a monocentric, randomized pilot study conducted at the Max Planck Institute of Psychiatry, Munich. The study investigates the effects of two different intermittent theta-burst stimulation (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition (PCC). Participants will be randomized into two arms, both receiving a total of 30 active iTBS sessions applied to the left dorsolateral prefrontal cortex (DLPFC) at 90% resting motor threshold using a PowerMAG 100 ppTMS stimulator:\n\n* Standard Arm: One iTBS session per day, five days per week, over six weeks.\n* Intensified Arm: Six iTBS sessions per day, approximately one-hour apart, over five consecutive days.\n\nThe primary outcomes are changes in immunological blood markers (C-reactive protein \\[CRP\\], tumor necrosis factor \\[TNF\\], interleukin-1β \\[IL-1β\\], interleukin-6 \\[IL-6\\]) and depressive symptomatology measured by Beck Depression Inventory-II (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes include fatigue (Fatigue Severity Scale \\[FSS\\], Fatigue Scale for Motor and Cognitive Functions \\[FSMC\\], Post-Exertional Malaise questionnaire \\[PEM\\]), sleep quality (Pittsburgh Sleep Quality Index \\[PSQI\\]), daytime sleepiness (Epworth Sleepiness Scale \\[ESS\\]), functioning (Sheehan Disability Scale \\[SDS\\]), anxiety (Beck Anxiety Inventory \\[BAI\\]) and an exploratory adverse effect screening. Follow-up assessments will be performed three days after treatment completion and again at three months post-intervention to evaluate both short- and medium-term effects. Biospecimen collection will include approximately 141 ml of peripheral blood per participant across three time points (baseline, post-treatment, +3 days). Samples will be analyzed for inflammatory markers and securely stored in the institutional biobank of the Max Planck Institute of Psychiatry in accordance with data protection and ethical guidelines. Safety and tolerability will be continuously monitored, including documentation of adverse events. The results of this pilot study are expected to provide preliminary evidence on whether accelerated iTBS protocols may exert differential effects on neuroinflammatory processes and depressive symptomatology in patients with Post-COVID-19 condition, thereby informing larger controlled clinical trials.","conditions":["Depressive Disorder","Post-Acute COVID-19 Syndrome"],"keywords":["Major depressive disorder","Post-COVID-19-condition","neuropsychology","psychometry","Immunemarkers","IL-6","TNF","CRP","repetitive transcranial magnetic stimulation","intermittent theta burst","accelerated rTMS","neuroinflammation"],"interventions":[{"type":"DEVICE","name":"Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS"}],"enrollment":42,"startDate":"2025-09-11","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-65 years\n* Capacity to consent (legally competent, written informed consent including data protection)\n* Diagnosis of depression (at least moderate severity, BDI-II ≥ 20), including major depressive episode in bipolar disorder\n* Comorbid diagnosis of Post-COVID-19 condition (WHO definition)\n* Insufficient improvement of depressive symptoms under psychopharmacological treatment\n* Stable psychopharmacological medication for at least 4 weeks prior to start of iTBS\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>65 years\n* Pregnancy, planned pregnancy, or breastfeeding\n* Legal guardianship or cognitive impairment preventing valid informed consent\n* Severe developmental disorder or intellectual disability\n* Acute or chronic substance abuse (alcohol, prescription drugs, or illicit drugs)\n* Current treatment with benzodiazepines or Z-substances\n* Acute suicidality\n* Psychotic symptoms\n* Severe neurological disorder (e.g., major brain injury, neurodegenerative disease)\n* Ongoing treatment with another neurostimulation method (ECT, TMS, VNS)\n* Contraindications to TMS, including: Intracranial metal, implants, shunts, Cochlear implant, pacemaker, implantable defibrillator, History of seizures or epileptiform EEG\n* Severe general medical illness (e.g., anemia requiring transfusion, severe arrhythmias, cardiomyopathy)","locations":[{"facility":"Max-Planck-Institute of Psychiatry","city":"Munich","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alexandros Balaskas, MD","phone":"0049-089-30622-1402","email":"Ambulanz@psych.mpg.de"},{"name":"Angelika Erhardt-Lehmann, MD, Prof.","phone":"","email":""}],"primaryOutcomes":["Change in immunophenotypic marker CRP from baseline to post-treatment","Change in immunophenotypic marker TNF from baseline to post-treatment","Change in immunophenotypic marker IL-1ß from baseline to post-treatment","Change in immunophenotypic marker IL-6 from baseline to post-treatment","Total score change in the Becks Depression Inventory, version 2 (BDI-II, self-rating)","Total score change in the clinician-rated Montgomery Asberg Depression scale (MADRS)"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["munich-germany"],"enrichment":{"headline":"Not a traditional drug phase: Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS for Depressive Disorder","inPlainEnglish":"This is a monocentric, randomly assigned pilot study conducted at the Max Planck Institute of Psychiatry, Munich. The study investigates the effects of two different intermittent theta-burst stimulation (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition (PCC).","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of depression (at least moderate severity, BDI-II ≥ 20), including major depressive episode in bipolar disorder","Comorbid diagnosis of Post-COVID-19 condition (WHO definition)","Insufficient improvement of depressive symptoms under psychopharmacological treatment","Stable psychopharmacological medication for at least 4 weeks prior to start of iTBS"],"whoShouldSkip":["Age \\<18 years or \\>65 years","Pregnancy, planned pregnancy, or breastfeeding","Severe developmental disorder or intellectual disability","Acute or chronic substance abuse (alcohol, prescription drugs, or illicit drugs)","Current treatment with benzodiazepines or Z-substances","Severe neurological disorder (e.g., major brain injury, neurodegenerative disease)","Ongoing treatment with another neurostimulation method (ECT, TMS, VNS)"],"whatHappens":"If you join, the listed intervention(s) are Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS. The registry lists allocation as randomized. This is a monocentric, randomly assigned pilot study conducted at the Max Planck Institute of Psychiatry, Munich.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 42 people at Munich. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.235Z"},{"nctId":"NCT07197554","title":"A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies","officialTitle":"A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"SEED Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies","conditions":["Advanced Solid Tumors","Ewing Sarcoma","Hepatocellular Carcinoma (HCC)","Biliary Tract Cancer (BTC)"],"keywords":["cancer","solid tumors","RBM39","RBM39 degrader","metastatic solid malignancies","Ewing sarcoma","Hepatocellular carcinoma","HCC","Biliary tract carcinoma","endometrial carcinoma","Adolescents"],"interventions":[{"type":"DRUG","name":"ST-01156"}],"enrollment":171,"startDate":"2025-12-01","completionDate":"2029-12-31","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.\n* Has a metastatic or locally advanced and unresectable solid tumor.\n* Has at least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* Has an ECOG performance status ≤ 2 at screening.\n* Has adequate organ function as defined in the protocol.\n\nExclusion Criteria:\n\n* Has received prior radiotherapy within 2 weeks of treatment.\n* Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.\n* Had major surgery within 28 days before study therapy administration\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.\n* Has previously received a RBM39 inhibitor/degrader.","locations":[{"facility":"The City of Hope National Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hoag Memorial Hospital","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass General Brigham Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr. Eric Rowinsky Chief Medical Officer","phone":"(908) 883-0647","email":"erowinsky@oncodrugs.com"}],"primaryOutcomes":["Part 1: Dose Escalation","Part 1: Dose Escalation"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","newport-beach-california","boston-massachusetts","new-york-new-york","houston-texas"],"enrichment":{"headline":"Phase 1: testing ST-01156 for Advanced Solid Tumors","inPlainEnglish":"A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies","whoItsFor":["Ages 16 Years to any","Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old","Has a metastatic or locally advanced and unresectable solid tumor","Has at least 1 measurable lesion or evaluable disease per RECIST v1.1","Has an how well you can do daily activities (ECOG score) ≤ 2 at screening","Has adequate organ function as defined in the protocol"],"whoShouldSkip":["Has received prior radiotherapy within 2 weeks of treatment","Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable","Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter","Had major surgery within 28 days before study therapy administration","Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy","Has previously received a RBM39 inhibitor/degrader"],"whatHappens":"If you join, the listed intervention(s) are ST-01156. The registry lists allocation as na. A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 171 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.633Z"},{"nctId":"NCT07198074","title":"Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer","officialTitle":"A Randomized Phase III Trial of Carboplatin, Paclitaxel, Pembrolizumab Versus Carboplatin, Paclitaxel, Bevacizumab Versus Carboplatin, Paclitaxel, Pembrolizumab, Bevacizumab in the Treatment of pMMR, TP53 Mutated Advanced or Recurrent Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Adding bevacizumab to the combination of carboplatin, paclitaxel and pembrolizumab may be more effective than the usual treatment combinations of carboplatin and paclitaxel with or without pembrolizumab in treating patients with advanced or recurrent pMMR and TP53 mutated endometrial cancer.","conditions":["Advanced Endometrial Carcinoma","Recurrent Endometrial Carcinoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Carboplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Paclitaxel"},{"type":"BIOLOGICAL","name":"Pembrolizumab"}],"enrollment":255,"startDate":"2026-01-27","completionDate":"2028-07-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documentation of disease:\n\n  * Stage III and stage IVA endometrial cancers (with measurable disease),\n  * Stage IVB endometrial cancer (with or without measurable disease), or\n  * Recurrent endometrial cancer (with or without measurable disease)\n* In patients with measurable disease, lesions will be defined and monitored by RECIST 1.1. Measurable disease (RECIST 1.1) is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by CT or MRI. Lymph nodes must be ≥ 15 mm in short axis when measured by CT or MRI\n* Histologic confirmation of the original primary tumor is required (submission of pathology report\\[s\\] is required). Patients with the following histologic types are eligible: endometrioid, serous, dedifferentiated/undifferentiated, clear cell, mixed epithelial, carcinosarcoma, adenocarcinoma not otherwise specified (N.O.S.)\n* Patients must have:\n\n  * Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND\n  * P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted\n* A pathology report demonstrating results of institutional MMR IHC and p53 IHC and/or TP53 by next-generation sequencing\n* Patients may have received:\n\n  * NO prior chemotherapy for treatment of endometrial cancer OR\n  * Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy \\[with or without cisplatin\\]) provided adjuvant chemotherapy was completed ≥ 12 months prior to registration\n* Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para-aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy. All radiation therapy must be completed at least 4 weeks prior to registration. For patients with recent radiation, they must have RECIST-evaluable disease outside of the radiation field and have recovered their marrow function\n* Patients may have received prior hormonal (endocrine) therapy. All hormonal (endocrine) therapy must have been completed at least 1 week prior to registration\n* NO prior pembrolizumab (or other anti-PD1, anti-PDL1 or anti-CTLA4 therapy) or bevacizumab (or other antiangiogenic therapy)\n* Interval or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted\n* Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n* Platelets ≥ 100,000 cells/mm\\^3\n* Hemoglobin ≥ 8 g/dl\n* Creatinine clearance (CrCl) of ≥ 30 mL/min by the Cockcroft-Gault formula\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better\n* No active infection requiring parenteral antibiotics\n* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube\n* No clinically significant bleeding within 28 days prior to registration\n* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg\n* No major surgery within 28 days of initiation of bevacizumab\n* No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease\n\n  * Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible\n  * Topical or inhaled steroids are allowed\n  * Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), and anti-thyroid antibodies should be evaluated with the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible\n* No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis\n* No history of stem cell or solid organ transplant\n* No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","locations":[{"facility":"University of Alabama at Birmingham Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Women's Cancer Care","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Banner University Medical Center - 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(PFS)"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["birmingham-alabama","anchorage-alaska","phoenix-arizona","tucson-arizona","fayetteville-arkansas","little-rock-arkansas","rogers-arkansas","springdale-arkansas","carmichael-california","dublin-california","elk-grove-california","fremont-california","fresno-california","los-angeles-california","modesto-california","oakland-california","palo-alto-california","rancho-mirage-california","rocklin-california","roseville-california","sacramento-california","san-francisco-california","san-jose-california","san-leandro-california","san-rafael-california","santa-clara-california","santa-rosa-california","south-san-francisco-california","vallejo-california","walnut-creek-california","woodland-california","aurora-colorado","colorado-springs-colorado","fort-collins-colorado","greeley-colorado","highlands-ranch-colorado","loveland-colorado","hartford-connecticut","manchester-connecticut","new-britain-connecticut","millville-delaware","newark-delaware","rehoboth-beach-delaware","washington-d-c-district-of-columbia","n-venice-florida","sarasota-florida","venice-florida","atlanta-georgia","augusta-georgia","decatur-georgia","honolulu-hawaii","aiea-hawaii","ewa-beach-hawaii","coeur-dalene-idaho","post-falls-idaho","sandpoint-idaho","chicago-illinois","danville-illinois","decatur-illinois","dekalb-illinois","effingham-illinois","evanston-illinois","geneva-illinois","glenview-illinois","harvey-illinois","highland-park-illinois","mattoon-illinois","new-lenox-illinois","normal-illinois","ofallon-illinois","oak-brook-illinois","oak-park-illinois","orland-park-illinois","peoria-illinois","springfield-illinois","urbana-illinois","warrenville-illinois","crown-point-indiana","goshen-indiana","indianapolis-indiana","south-bend-indiana","ankeny-iowa","carroll-iowa","cedar-rapids-iowa","clive-iowa","des-moines-iowa","fort-dodge-iowa","iowa-city-iowa","waukee-iowa","lexington-kentucky","marrero-louisiana","metairie-louisiana","new-orleans-louisiana","brewer-maine","scarborough-maine","baltimore-maryland","boston-massachusetts","burlington-massachusetts","peabody-massachusetts","ann-arbor-michigan","battle-creek-michigan","brighton-michigan","canton-michigan","chelsea-michigan","detroit-michigan","escanaba-michigan","farmington-hills-michigan","flint-michigan","grand-rapids-michigan","kalamazoo-michigan","lansing-michigan","livonia-michigan","manistique-michigan","muskegon-michigan","niles-michigan","norton-shores-michigan","pontiac-michigan","reed-city-michigan","saint-joseph-michigan","traverse-city-michigan","wyoming-michigan","ypsilanti-michigan","brainerd-minnesota","coon-rapids-minnesota","deer-river-minnesota","duluth-minnesota","edina-minnesota","hibbing-minnesota","minneapolis-minnesota","saint-louis-park-minnesota","saint-paul-minnesota","sandstone-minnesota","virginia-minnesota","woodbury-minnesota","columbia-missouri","springfield-missouri","st-louis-missouri","anaconda-montana","billings-montana","bozeman-montana","great-falls-montana","kalispell-montana","missoula-montana","bellevue-nebraska","kearney-nebraska","omaha-nebraska","las-vegas-nevada","basking-ridge-new-jersey","camden-new-jersey","livingston-new-jersey","middletown-new-jersey","montvale-new-jersey","new-brunswick-new-jersey","newark-new-jersey","paramus-new-jersey","ridgewood-new-jersey","sewell-new-jersey","albuquerque-new-mexico","bay-shore-new-york","commack-new-york","flushing-new-york","greenlawn-new-york","harrison-new-york","lake-success-new-york","new-york-new-york","rego-park-new-york","rochester-new-york","sleepy-hollow-new-york","staten-island-new-york","stony-brook-new-york","syracuse-new-york","the-bronx-new-york","uniondale-new-york","webster-new-york","chapel-hill-north-carolina","clinton-north-carolina","durham-north-carolina","goldsboro-north-carolina","jacksonville-north-carolina","raleigh-north-carolina","fargo-north-dakota","athens-ohio","beachwood-ohio","canton-ohio","chardon-ohio","cleveland-ohio","columbus-ohio","delaware-ohio","dublin-ohio","mansfield-ohio","marion-ohio","mentor-ohio","parma-ohio","pickerington-ohio","sylvania-ohio","westerville-ohio","westlake-ohio","oklahoma-city-oklahoma","portland-oregon","tualatin-oregon","erie-pennsylvania","greensburg-pennsylvania","hershey-pennsylvania","mechanicsburg-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","washington-pennsylvania","willow-grove-pennsylvania","providence-rhode-island","franklin-tennessee","nashville-tennessee","salt-lake-city-utah","south-jordan-utah","charlottesville-virginia","richmond-virginia","edmonds-washington","issaquah-washington","seattle-washington","vancouver-washington","bridgeport-west-virginia","charleston-west-virginia","martinsburg-west-virginia","morgantown-west-virginia","parkersburg-west-virginia","ashland-wisconsin","green-bay-wisconsin","la-crosse-wisconsin","milwaukee-wisconsin","oconto-falls-wisconsin","sheboygan-wisconsin","spooner-wisconsin","sturgeon-bay-wisconsin","superior-wisconsin"],"enrichment":{"headline":"Phase 3: testing Bevacizumab for Advanced Endometrial Carcinoma","inPlainEnglish":"This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent). Bevacizumab is in a class of medications called antiangiogenic agents.","whoItsFor":["Ages 18 Years to any","Women only","Documentation of disease:","Stage III and stage IVA endometrial cancers (with measurable disease),","Stage IVB endometrial cancer (with or without measurable disease), or","Recurrent endometrial cancer (with or without measurable disease)","Patients must have:","Tumoral mismatch repair proficient (pMMR) disease as assessed by immunohistochemistry (IHC) AND","P53 IHC with aberrant staining pattern (aberrant p53 expression is consistent with mutant TP53). TP53 mutation by next-generation sequencing will also be accepted"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Bevacizumab, Biospecimen Collection, or Carboplatin. The registry lists allocation as randomized. This phase III trial compares the effect of bevacizumab in combination with carboplatin, paclitaxel and pembrolizumab to the usual treatments of carboplatin and paclitaxel with or without pembrolizumab in treating patients with stage III, IVA or IVB mismatch repair protein proficient (pMMR) and TP53 mutated endometrial cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has come back after a period of improvement (recurrent).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 255 people at 309 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.692Z"},{"nctId":"NCT07198113","title":"COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)","officialTitle":"Clinical Outcomes of Medications Post Anti-TNF: Researching Effectiveness in Pediatric IBD","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of North Carolina, Chapel Hill","sponsorClass":"OTHER","summary":"The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present. The main question this study aims to answer is:\n\nAre the newer medications used to treat IBD just as safe and effective for treating IBD in children.\n\nParticipants will already be taking these newer medications as assigned by their regular health care provider.Participants' care will be managed by their regular healthcare provider as part of usual (standard) care for those with PIBD. While taking these medications, participants will be asked to answer questions about their symptoms and health periodically over the course of the study.","conditions":["Ulcerative Colitis, Pediatric","Inflammatory Bowel Diseases","Crohn Disease"],"keywords":["Ulcerative colitis, pediatric","Inflammatory bowel disease, pediatric","IBD","CD","UC","PIBD","Pediatrics","Children","Anti-TNF","Vedolizumab","Ustekinumab","Risankizumab","Guselkumab","Mirikizumab","Tofacitinib","Upadacitinib","Patient-reported outcomes (PROs)","Tumor necrosis factor antagonists","IL-23 agent","PCORI","PCORnet","DCRI","Duke","UNC","University of North Carolina","Observational cohort","Anti-tumor necrosis factor (TNF) refractory","Comparative Effectiveness Research (CER)","COMPARE"],"interventions":[],"enrollment":1100,"startDate":"2025-11-01","completionDate":"2028-09","sex":"ALL","minAge":"1 Year","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\< 18 years at study enrollment\n* Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria\n* Prior non-response or loss of response to one or more anti-TNF agents\n* Planning to initiate treatment with any of the following comparator agents: vedolizumab (α4β7 integrin antibody), ustekinumab (anti-IL-12/23 antibody), risankizumab, guselkumab, or mirikizumab, (IL-23 inhibitors), tofacitinib (JAK inhibitor), and upadacitinib (JAK inhibitor). Biosimilars or generic medications for any of the above will also be allowed and handled/analyzed in an identical manner to originators.\n* Ability to provide child assent, if required per regulatory or local institutional guidelines, and parental informed consent in English or Spanish\n\nExclusion Criteria:\n\n* Plans to change care to a different center within 1 year\n* Prior use of a comparator agent (i.e., only patients starting their first comparator medication as monotherapy following anti-TNF will be eligible)\n* Contraindication to any of the treatments under investigation\n* Patients with UC or IBD-U who have undergone colectomy\n* Patients with current ostomy","locations":[{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Health System","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center, Children's Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Duke Clinical Research Institute COMPARE Call Center","phone":"833-850-2848","email":"COMPARE@dm.duke.edu"}],"primaryOutcomes":["Measure of Crohn's disease (CD) impact on patients' daily lives (TUMMY CD)","Measures of ulcerative colitis (UC) impact on patients' daily lives (TUMMY UC)","PROMIS Symptom Measure of Irritable Bowel Disease (IBD)","Change in Pediatric PROMIS® Patient-Reported Outcome (PRO) Pain Interference Score for Crohn's Disease and Ulcerative Colitis (CD and UC)","Change in Pediatric PROMIS® Fatigue Score for Crohn's Disease and Ulcerative Colitis (CD and UC)","Change in Pediatric PROMIS® Anxiety Score for Crohn's Disease and Ulcerative Colitis (CD and UC)","Change in Pediatric PROMIS® Depression Score for Crohn's Disease and Ulcerative Colitis (CD and UC)","Change in sPCDAI Score for Crohn's Disease","Change in Pediatric Ulcerative Colitis Activity Index (PUCAI) Score"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["chapel-hill-north-carolina","charlotte-north-carolina","durham-north-carolina","pittsburgh-pennsylvania"],"enrichment":{"headline":"COMPARE - Pediatric Inflammatory Bowel Disease (PIBD)","inPlainEnglish":"The purpose of the study is to compare the clinical effectiveness and safety of newer inflammatory bowel disease (IBD) medications in anti-tumor necrosis factor (TNF) refractory patients with pediatric IBD (PIBD). Refractory means that there was no clinical response to anti-tumor necrosis factor (TNF) drugs or that the if there was a response, it is no longer present.","whoItsFor":["Ages 1 Year to 18 Years","Age \\< 18 years at study enrollment","Diagnosis of CD, UC, or IBD-U by standard diagnostic criteria","Prior non-response or loss of response to one or more anti-TNF agents"],"whoShouldSkip":["Plans to change care to a different center within 1 year","Prior use of a comparator agent (i.e., only patients starting their first comparator medication as this drug alone following anti-TNF will be eligible)","Contraindication to any of the treatments under investigation","Patients with UC or IBD-U who have undergone colectomy","Patients with current ostomy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,100 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.583Z"},{"nctId":"NCT07199634","title":"Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0)","officialTitle":"Integrating U=U Into HIV Counseling in South Africa (INTUIT-2.0): a Cluster-Randomized Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boston University","sponsorClass":"OTHER","summary":"Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally. Many PLHIV delay or avoid ART because they feel healthy and perceive little benefit, while also fearing stigma, disclosure, and social costs. U=U offers powerful motivation for ART uptake and adherence by reframing treatment as both a personal health and prevention tool, reducing internalised stigma, strengthening self-image, and supporting HIV prevention altruism. Yet, dissemination in Africa has lagged. To address this, the investigators developed an HIV treatment literacy App called \"Undetectable \\& You\", which delivers accurate U=U information alongside real-life video testimonials of PLHIV and their partners. This research will assess the impact of the \"Undetectable \\& You\" App in a cluster-randomized trial in South Africa. The study will establish whether disseminating U=U information via a video-based app at the time of HIV counselling improves retention in care and viral suppression among PLHIV in South Africa.\n\nAim 1. Refine the \"Undetectable \\& You\" App to help PLHIV navigate U=U within relationships.\n\nAim 2. Establish the real-world impact of \"Undetectable \\& You\" on retention on ART and viral suppression in a cluster-randomized trial.","conditions":["HIV"],"keywords":["HIV Counseling South Africa","Antiretroviral treatment (ART)","Person living with HIV (PLWH)","Undetectable=Untransmittable (U=U)","Viral load"],"interventions":[{"type":"OTHER","name":"\"Undetectable & You\" HIV treatment literacy app"}],"enrollment":880,"startDate":"2026-10-05","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria-\n\nClinic inclusion criteria:\n\n* Public sector facility\n* Primary care, outpatient clinic\n* Follows national guidelines for HIV counseling\n* Has dedicated HIV counselors\n* At least 10 patients receiving HIV counseling per week (based on pre-study data)\n* Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)\n* Is interested in participating, as indicated by \"sign-off\" from the head nurse / facility director\n\nIndividual participant inclusion criteria:\n\n* Adult (at least 18 years)\n* Received HIV post-test counselling or adherence counseling\n* Able to consent\n* Provides informed consent\n* Speaks one of the primary study languages: English, Zulu, Sotho, Tsonga\n* Receives care at the facility as evidence by having a clinical record there\n\nIndividual participant exclusion Criteria:\n\n* Require acute medical care that would be hindered by participation in the study\n* Determined by clinical staff not to be physically or emotionally able to initiate ART\n* Children (under 18 years).\n* Prisoners or other institutionalized persons.\n* Do not speak one of the primary study languages: English, Zulu, Sotho\n* Are not able to consent (e.g. intoxicated or of limited mental capacity)\n* Do not consent to participate in the study, including linkage to clinical records for follow-up","locations":[{"facility":"University of Witwatersrand","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jacob Bor, ScD, SM","phone":"(617) 414-1446","email":"jbor@bu.edu"},{"name":"Dorina Onoya, PhD, MBA","phone":"","email":"donoya@heroza.org"}],"primaryOutcomes":["HIV viral load <200 copies/mL"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["johannesburg-south-africa"],"enrichment":{"headline":"Not a traditional drug phase: \"Undetectable & You\" HIV treatment literacy app for HIV","inPlainEnglish":"Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually. While global studies confirm this, awareness of U=U remains very limited in sub-Saharan Africa, including South Africa, where only two-thirds of people living with HIV (PLHIV) are virally suppressed despite having the largest treatment program globally.","whoItsFor":["Ages 18 Years to any","Clinic who can join:","Public sector facility","Primary care, outpatient clinic","Follows national guidelines for HIV counseling","Has dedicated HIV counselors","At least 10 patients receiving HIV counseling per week (based on pre-study data)","Follows national guidelines for lab monitoring (CD4 at diagnosis; VLs at 3 and 10 months on ART)"],"whoShouldSkip":["Require acute medical care that would be hindered by participation in the study","Determined by clinical staff not to be physically or emotionally able to initiate ART","Children (under 18 years)","Prisoners or other institutionalized persons","Do not speak one of the primary study languages: English, Zulu, Sotho","Are not able to consent (e.g. intoxicated or of limited mental capacity)","Do not consent to participate in the study, including linkage to clinical records for follow-up"],"whatHappens":"If you join, the listed intervention(s) are \"Undetectable & You\" HIV treatment literacy app. The registry lists allocation as randomized. Undetectable = Untransmittable (U=U) is the scientific consensus that people with human immunodeficiency virus (HIV) who achieve viral suppression through antiretroviral treatment (ART) cannot transmit the virus sexually.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 880 people at Johannesburg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.524Z"},{"nctId":"NCT07201558","title":"Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE Participants","officialTitle":"An Open-label, Phase I Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Surovatamig Following Single-ascending Dose and Step-up Dose Administration to Adult Participants With Rheumatoid Arthritis or Systemic Lupus Erythematosus","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This open-label, Phase I study will assess the safety and tolerability of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.","conditions":["Rheumatoid Arthritis","Systemic Lupus Erythematosus"],"keywords":["adult participants","rheumatoid arthritis","systemic lupus erythematosus","surovatamig"],"interventions":[{"type":"BIOLOGICAL","name":"Surovatamig"}],"enrollment":48,"startDate":"2025-12-02","completionDate":"2028-06-27","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant must be 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 65 years of age, inclusive, at the time of signing the informed consent.\n2. For RA participants, only:\n\n<!-- -->\n\n1. Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria\n2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory.\n\n   (a) RF (b) ACPA\n3. Moderate or severe disease activity defined as:\n\nDAS28-CRP \\> 3.2 AND\n\n* 4 tender joints and ≥ 4 swollen joints\n\n  (a) US-Specific Criterion: DAS28-CRP \\> 3.2 AND ≥ 6 tender joints and ≥ 6 swollen joints 4. Intolerance to or inadequate response following approximately 3 month's treatment or longer to ≥2 b/tsDMARDs (with different mechanisms of action) after failing csDMARD therapy (unless csDMARD therapy is contraindicated). There is no minimum duration for taking a treatment in cases of intolerance.\n\n  5\\. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12:\n\n  (a) Oral prednisone (or equivalent). Dose must be stable and ≤ 10mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (e.g. hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following csDMARDs for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg per week, without change of route of administration for 8 weeks prior to Day 1 (ii) Sulfasalazine ≤ 3g/day (iii) Leflunomide ≤ 20 mg/day 3. For SLE participants, only:\n  1. Diagnosis of SLE as defined by the 2019 EULAR/ACR classification criteria\n  2. Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory. If autoantibodies are negative on central laboratory test, documented history of test results may be used. (a) ANA immunofluorescent assay test (titer ≥ 1:80) (a) Anti-dsDNA (b) Anti-Sm.\n  3. Moderate or severe disease activity defined as clinical SLEDAI-2K \\> 4\n\n     (a) US-specific criterion: clinical SLEDAI-2K ≥ 6\n  4. Intolerance to or inadequate response following approximately 3 months treatment or longer ≥ 3 SoC (includes: corticosteroids, anti-malarial drugs, calcineurin inhibitor, methotrexate, azathioprine, leflunomide, mycophenolic acid or its derivatives, cyclophosphamide, belimumab, anifrolumab, telitacicept, or B-cell depleting monoclonal antibodies). There is no minimum duration for taking a treatment in cases of intolerance.\n  5. Background standard of care is not a requirement for participation, however, the following therapies are permitted and may be continued during the study (alone or in combination). Any other systemic immunosuppressive treatment or immune modulating biologic drug must be discontinued in line with the washout periods listed in Inclusion Criterion 12: (a) Oral prednisone (or equivalent. Dose must be stable and ≤ 20mg a day for ≥ 2 weeks prior to Day 1. (b) Oral anti-malarial (eg, hydroxychloroquine ≤ 400 mg a day). Dose must be stable for ≥ 4 weeks prior to Day 1. (c) Treatment with one of the following immunosuppressive treatments. for ≥ 3 months and at a stable dose for ≥ 4 weeks prior to Day 1. (i) Methotrexate ≤ 25 mg/week, without change of route of administration for 8 weeks prior to Day 1 (ii) Mycophenolate mofetil or equivalent ≤ 2 g/day (dose must be ≤ 2 g/day for 3 months prior to Day 1) (iii) Azathioprine ≤ 200 mg/day (iv) Leflunomide ≤ 20 mg/day (v) Tacrolimus ≤ 0.1 mg/kg/day with maximum dose of 5 mg/day (vi) Cyclosporin ≤ 3 mg/kg/day with maximum dose of 200 mg/day\n\n  4\\. Blood B cells ≥ 50 cells/μL at screening. 5. IgG levels ≥ 6 g/L at screening. 6. Eligibility for re-treatment of previously treated participants only. The following criterion applies only to participants being considered for re-treatment and is not applicable to participants undergoing initial screening for study entry.\n\n  1\\. Participants treated in prior study cohorts who did not experience an IMP-related DLT or discontinue treatment and/or participation due to an IMP-related AE are eligible for re-treatment in Parts 2 and 3. Participants must otherwise meet all protocol-defined eligibility criteria, with the exception of Inclusion Criterion 17 (B cell count), and meet one of the 2 criteria below:\n  1. Completed the 6-month treatment period OR\n  2. Completed a minimum of 90 days in the treatment period and have peripheral B cell counts that are ≥ 90% of baseline or above lower limit of normal (LLN)\n\n     Exclusion Criteria:\n     1. Any complications of disease under study that are judged by the Investigator to be life or organ threatening or to require treatments which are not permitted in the protocol, including but not limited to: (a) Active severe SLE-driven renal disease. (b) Severe lung or cardiac involvement. (c) History of, or current diagnosis of, catastrophic or severe APS (eg, diagnosis of an arterial or central/pulmonary venous clot) within 1 year prior to signing the ICF. Participants with clinically evident APS which is adequately controlled by anticoagulants or aspirin for at least 12 weeks can be recruited into the study. (d) Rapidly progressive and/or severe ILD or ILD that requires oxygen supplementation/therapy (of any type). (e) Felty's syndrome\n     2. History of HLH/MAS.\n     3. For RA participants, only:\n\n     <!-- -->\n\n     1. Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16.\n     2. Axial spondylarthritis or any other disease associated with inflammatory arthritis\n\n     4\\. For SLE participants, only:\n\n     1.History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this exclusion criteria include: (a) Vitiligo or alopecia (b) Hypothyroidism stable on hormone replacement (c) Controlled type I diabetes mellitus on insulin (d) Any chronic skin condition that does not require systemic immunosuppressant or biologic therapy (e) Celiac disease, controlled by diet alone (f) Participants with secondary Sjögren's disease are eligible provided that immunosuppression is primarily prescribed for the disease under study (ie, SLE or RA) and not for secondary Sjögren's. 6. Significant CNS co-morbidity (eg, Parkinson's, stroke, CNS vasculitis, severe brain injury, dementia, neurodegenerative diseases, cerebellar disease, epilepsy/seizure disorders, PML, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases).\n\n     7\\. Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection.\n\n     8\\. Exclusion Criteria Related to Infection:\n\n     1\\. Any clinical suspicion or diagnosis of active infection at screening. 2. Opportunistic infection that meets criteria to be an SAE within 3 years. 3. Clinically significant chronic infection (for example osteomyelitis, bronchiectasis) with treatment completed less than 2 months prior to signing the ICF (except for chronic nail infections which are not exclusionary) 4. Any infection requiring hospitalisation or treatment with IV anti-infectives with treatment completed less than 4 weeks prior to signing the ICF.\n\n     5\\. Any infection requiring oral anti-infectives within 2 weeks prior to signing the ICF.\n\n     6\\. History of recurrent infection requiring hospitalisation or IV antibiotics (eg, 3 or more of the same type of infection, including systemic fungal infections, over the previous 52 weeks).\n\n     9\\. Participants who, as judged by the Investigator, have evidence of active TB, or latent TB or have a household contact with known diagnosis of current active TB.\n\n  <!-- -->\n\n  1. TB evaluation will be performed according to the local SoC as determined by local guidelines and may include history and physical examinations, chest X-ray, or TB test (eg, purified protein derivative or QuantiFERON® test).\n  2. Participants with a prior diagnosis of active or latent TB who have documented evidence they have completed a full course of appropriate treatment are not excluded.\n\n     However, a previous history of multidrug-resistant or extensively drug-resistant TB is exclusionary regardless of treatment status. 10. Participant with human immunodeficiency virus infection (confirmed by central laboratory at screening) 11. Participant with active EBV or CMV, assessed clinically. 12. Participant with evidence of chronic or active hepatitis B defined as HBsAg positive or HBcAB positive (tested at screening visit).\n\n     13\\. Participant with evidence of chronic or active Hepatitis C, meeting any of the criteria below: (a) HCV RNA positive or detectible at screening (b) HCV antibody positive at screening (apart from those with negative HCV RNA \\>12 weeks after completion of curative antiviral treatment for HCV or those with sustained negative HCV RNA 12 weeks apart following resolution of HCV infection if not treated).\n\n     14\\. Participant positive with COVID-19 PCR at screening. If patients test positive at screening or Day 1 but meet other eligibility criteria, they may be re-tested after ≥ 2 weeks. If this falls within the screening window, then they do not require re-screening.\n\n     15\\. Receipt of any of the following treatments or interventions ever: (a) TCEs, with the exception of surovatamig under the conditions specified in Inclusion Criterion 19 (b) Bone marrow transplant (c) Stem cell transplant (d) Total lymphoid irradiation (e) CAR-T cell therapy (f) Alemtuzumab 16. For females only - currently pregnant (confirmed with positive pregnancy test), planning to become pregnant within the study period, or breast feeding.","locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Plantation","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Allen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mesquite","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Birtinya","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Clayton","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Edegem","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leuven","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Merksem (Antwerpen)","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Porto Alegre","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Salvador","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jena","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mainz","state":"","country":"Germany","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"München","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Córdoba","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ternopil","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Vinnytsia","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Safety evaluation of surovatamig: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs)","Safety evaluation of surovatamig: Frequency of dose limiting toxicities (DLTs).","Safety of surovatamig: Incidence of AEs/SAEs leading to discontinuation of surovatamig","Tolerability of surovatamig: Incidence of treatment-related vital signs abnormalities","Tolerability of surovatamig: Incidence of treatment-related clinical laboratory abnormalities","Tolerability of surovatamig: Number of participants with abnormal ECG"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","fullerton-california","plantation-florida","st-louis-missouri","allen-texas","mesquite-texas","birtinya-australia","clayton-australia","edegem-belgium","leuven-belgium","li-ge-belgium","merksem-antwerpen-belgium","porto-alegre-brazil","salvador-brazil","s-o-paulo-brazil","beijing-china","chengdu-china","nanjing-china","bonn-germany","jena-germany","mainz-germany","m-nchen-germany","m-nster-germany","barcelona-spain","c-rdoba-spain","madrid-spain","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","taoyuan-taiwan","kyiv-ukraine","ternopil-ukraine","vinnytsia-ukraine","london-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Surovatamig for Rheumatoid Arthritis","inPlainEnglish":"This open-label, Phase I study will assess the whether it is safe and how hard side effects are to live with of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.","whoItsFor":["Ages 18 Years to 65 Years","For RA participants, only:","Diagnosis of RA as defined by the 2010 EULAR/ACR classification criteria","Positive for ≥ 1 disease-specific autoantibody performed by the central laboratory","Moderate or severe disease activity defined as:","DAS28-a blood inflammation marker (CRP) \\> 3.2 AND","4 tender joints and ≥ 4 swollen joints","Diagnosis of SLE as defined by the 2019 EULAR/ACR classification criteria"],"whoShouldSkip":["History of HLH/MAS","For RA participants, only:","Juvenile idiopathic arthritis or idiopathic arthritis diagnosed before the age of 16","Axial spondylarthritis or any other disease associated with inflammatory arthritis","4\\. For SLE participants, only:","History of active, severe or unstable neuropsychiatric SLE, except for headache and peripheral neuropathies. 5. Other active or prior documented severe, complex, autoimmune or inflammatory disorders. Exceptions to this"],"whatHappens":"If you join, the listed intervention(s) are Surovatamig. The registry lists allocation as randomized. This open-label, Phase I study will assess the whether it is safe and how hard side effects are to live with of surovatamig and characterise its PK and PD following subcutaneous administration to participants with RA or SLE.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 48 people at 34 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.959Z"},{"nctId":"NCT07204977","title":"Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)","officialTitle":"Acamprosate in C9orf72 Hexanucleotide Repeat Expansion Amyotrophic Lateral Sclerosis (ACALS)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Neurological Disorders and Stroke (NINDS)","sponsorClass":"NIH","summary":"Background:\n\nAmyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord. It can cause muscle weakness, paralysis, and loss of movement. The symptoms grow worse over time. Half of all people with ALS live only 3 to 5 years after diagnosis. Current drug treatments can slow the progress of the disease, but they cannot stop or reverse it.\n\nObjective:\n\nTo test a study drug (acamprosate) in people with ALS with a mutation in the C9orf72 gene.\n\nEligibility:\n\nPeople aged 18 years and older with ALS. They must have a mutation in the C9orf72 gene.\n\nDesign:\n\nParticipants will have 13 visits over 32 weeks. Five visits will be at the clinic, and 8 visits will be by phone.\n\nParticipants will have a baseline visit of up to 3 days. They will have a physical exam with blood tests. They will have imaging scans and tests of their breathing ability. Their memory, thinking, and behavior will be assessed. They will have a neurologic exam to check their reflexes, strength, balance, eyes, and coordination. They will complete questionnaires about their daily life. They will have a lumbar puncture to collect fluid from the area around the spinal cord.\n\nAcamprosate is a pill taken by mouth. Participants will take 2 pills by mouth 3 times a day with meals for 24 weeks. They will record their doses and any missed doses in a diary.\n\nBaseline tests will be repeated during follow-up clinic visits. These tests may be spread out over 3 days.\n\nDuring phone visits, participants will talk about how they are doing. They will review their diary with researchers.","conditions":["Amyotrophic Lateral Sclerosis","Motor Neuron Disease"],"keywords":["Amyotrophic Lateral Sclerosis","Clinical Trial","Acamprosate","C9ORF72"],"interventions":[{"type":"DRUG","name":"Acamprosate calcium"}],"enrollment":30,"startDate":"2026-02-02","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following inclusion criteria:\n\n1. Aged 18 years or older at the time of the screening visit.\n2. Able to provide informed consent and comply with study procedures and availability for the duration of the study. If a participant lacks capacity to give consent, a Legally Authorized Representative (LAR) will be authorized to give consent on behalf of the individual.\n3. Diagnosis of ALS (possible, probable, or definite according to the World Federation of Neurology El Escorial revised criteria or the Gold Coast Criteria) with or without mild cognitive impairment, mild behavioral impairment, or frontotemporal dementia (FTD).\n4. CLIA-certified genetic testing showing a pathogenic hexanucleotide repeat expansion in the C9orf72 gene.\n5. Symptom duration less than 2 years, or if greater than 2 years, disease progression at a rate that, in the judgement of the investigator, would allow for completion of the study.\n6. If taking riluzole, edaravone, or phenylbutyrate/TUDCA, the participant must be on a stable dose for at least 30 days prior to the screening visit, or have stopped taking riluzole, edaravone, or phenylbutyrate/TUDCA at least 30 days prior to the baseline visit.\n7. Participant must be competent to self-administer the medication as deemed by study team. Alternatively, participant must have a competent caregiver who can and will be responsible for administering the study drug. If there is no caregiver, another qualified individual must be available to administer the study drug.\n8. Participant has established care with a neurologist and will maintain this clinical care throughout the study.\n9. For females of reproductive potential: use of effective or highly effective contraception for at least one month prior to screening and agreement to use such a method during study participation and for an additional 8 weeks after the end of acamprosate administration. Participants of childbearing potential must have a negative pregnancy test at screening.\n10. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Dependence on daytime mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) at the time of the screening visit.\n2. Participation in any other investigational drug trial or using investigational drug(s) (within 4 weeks prior to the Day 0 visit and thereafter).\n3. Participants must not become pregnant or breastfeed for the duration of the study. Participants of childbearing potential must have a negative pregnancy test at screening and be non-lactating.\n4. Men who are trying to become fathers or donate sperm.\n5. History of positive test or positive result at screening for HIV.\n6. History of severe sulfite allergy (i.e., anaphylaxis).\n7. Presence of any of the following clinical conditions at the time of screening:\n\n   1. Active drug abuse or alcoholism.\n   2. Unstable medical condition that, in the opinion of the investigators, makes participation unsafe.\n   3. Renal impairment estimated glomerular filtration rate \\<=60mL/min/1.73m\\^2.\n   4. Unstable psychiatric illness defined as psychosis or untreated major depression within 90 days of the screening visit.\n8. Safety Laboratory Criteria at the screening visit:\n\n   1. Estimated glomerular filtration rate \\<=60mL/min/1.73m\\^2.\n   2. Platelet concentration of \\<100,000/microl.\n   3. PT and PTT \\>1.2 times the upper limit of normal.\n   4. Hemoglobin \\<10mg/dL.\n   5. Positive Hepatitis B Surface Antigen and Hepatitis C Virus Antibody\n9. Participants who are unable to swallow tablets whole, as required by the administration guidelines. This includes individuals with any medical condition or physical limitation that impedes their ability to swallow solid dosage forms.\n10. Participants who are dependent on a gastrostomy tube for medication administration. Since acamprosate is in tablet form that cannot be crushed or altered, it is unsuitable for administration through a gastrostomy tube.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol H Hoffman","phone":"(301) 451-1229","email":"carol.hoffman@nih.gov"},{"name":"Justin Y Kwan, M.D.","phone":"(301) 496-7428","email":"justin.kwan@nih.gov"}],"primaryOutcomes":["Safety of acamprosate in patients with ALS and mutation in C9orf72."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Acamprosate calcium for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Background: Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord. It can cause muscle weakness, paralysis, and loss of movement.","whoItsFor":["Ages 18 Years to 99 Years","In order to be eligible to participate in this study, an individual must meet all of the following who can join:","Aged 18 years or older at the time of the screening visit","Diagnosis of ALS (possible, probable, or definite according to the World Federation of Neurology El Escorial revised criteria or the Gold Coast Criteria) with or without mild cognitive impairment, mild behavioral impairment, or frontotemporal dementia (FTD)","CLIA-certified genetic testing showing a pathogenic hexanucleotide repeat expansion in the C9orf72 gene","Symptom duration less than 2 years, or if greater than 2 years, disease progression at a rate that, in the judgement of the investigator, would allow for completion of the study","If taking riluzole, edaravone, or phenylbutyrate/TUDCA, the participant must be on a stable dose for at least 30 days prior to the screening visit, or have stopped taking riluzole, edaravone, or phenylbutyrate/TUDCA at least 30 days prior to the baseline visit","Participant has established care with a neurologist and will maintain this clinical care throughout the study"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Dependence on daytime mechanical ventilation (invasive or non-invasive, including Continuous Positive Airway Pressure (CPAP) or Bilevel Positive Airway Pressure (BiPAP) at the time of the screening visit","Participation in any other investigational drug trial or using investigational drug(s) (within 4 weeks prior to the Day 0 visit and thereafter)","Participants must not become pregnant or breastfeed for the duration of the study. Participants of childbearing potential must have a negative pregnancy test at screening and be non-lactating","Men who are trying to become fathers or donate sperm","History of positive test or positive result at screening for HIV","History of severe sulfite allergy (i.e., anaphylaxis)"],"whatHappens":"If you join, the listed intervention(s) are Acamprosate calcium. The registry lists allocation as na. Background: Amyotrophic lateral sclerosis (ALS) is a disorder that damages nerve cells in the brain and spinal cord.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.619Z"},{"nctId":"NCT07205887","title":"A Dose-masked Study of Intravitreal Remigromig (EYE103) in Participants With NVAMD or Macular Edema Following BRVO","officialTitle":"A Phase 2 Randomized, Dose-Masked Study of Intravitreal EYE103 in Participants With Neovascular Age-Related Macular Degeneration (NVAMD) or Macular Edema Following Branch Retinal Vein Occlusion (BRVO)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"EyeBiotech Ltd.","sponsorClass":"INDUSTRY","summary":"EYE-RES-104 is a randomized, dose-masked study of intravitreal remigromig (EYE103) in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).\n\nThe study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of remigromig via IVT or a high dose of remigromig via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.\n\nAll participants in the study will receive a total of 3 injections of remigromig into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.","conditions":["Neovascular Age-Related Macular Degeneration (NVAMD)","Branch Retinal Vein Occlusion (BRVO)"],"keywords":["Neovascular Age-Related Macular Degeneration","Branch Retinal Vein Occlusion","NVAMD","BRVO"],"interventions":[{"type":"DRUG","name":"Remigromig"},{"type":"DRUG","name":"Aflibercept 2.0 mg"}],"enrollment":160,"startDate":"2025-09-12","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nKey General Inclusion Criteria\n\n• Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity\n\nKey Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria\n\n* Be ≥ 50 years of age\n* Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement\n* For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment\n\nKey Incomplete Responder (IR) NVAMD-specific Inclusion Criteria\n\n* Be ≥ 50 years of age\n* Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening\n* For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2\n\nKey Branch Retinal Vein Occlusion (BRVO)-specific Inclusion Criteria\n\n* Be diagnosed with BRVO in the study eye\n* Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO\n* Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening\n\nExclusion Criteria:\n\nKey General Exclusion Criteria\n\n* Pregnant or breastfeeding\n* History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening\n* Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening\n* Currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)\n\nKey NVAMD-specific Exclusion Criteria\n\n* Have had previous thermal subfoveal laser therapy in the study eye\n* Have had previous photodynamic therapy with Visudyne in the study eye\n\nKey BRVO-specific Exclusion Criteria\n\n* Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, diabetic macular edema, NVAMD, Irvine-Gass syndrome)\n* Have active iris or angle neovascularization or neovascular glaucoma in the study eye","locations":[{"facility":"Scottsdale, Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottsdale, AZ","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Glendale, California","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Glendale, CA","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Modesto, California","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mountain View, California","city":"Mountain View","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sacramento, CA","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sactamento, California","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sacramento, California","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Santa Ana, California","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"RSC Research LLC","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Lauderdale, Florida","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fort Lauderdale, FL","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Retina Institute","city":"Jacksonville","state":"Florida","country":"United 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States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Charles Miller, MD PhD","phone":"212-914-0127","email":"ClinicalInquiries@eyebiotech.com"}],"primaryOutcomes":["Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","glendale-california","modesto-california","mountain-view-california","sacramento-california","santa-ana-california","denver-colorado","fort-lauderdale-florida","jacksonville-florida","orlando-florida","lemont-illinois","hagerstown-maryland","madison-mississippi","bloomfield-new-jersey","great-neck-new-york","asheville-north-carolina","cary-north-carolina","greenville-north-carolina","wake-forest-north-carolina","west-columbia-south-carolina","germantown-tennessee","knoxville-tennessee","nashville-tennessee","abilene-texas","amarillo-texas","austin-texas","bellaire-texas","burleson-texas","dallas-texas","plano-texas","round-rock-texas","san-antonio-texas","san-marcos-texas","the-woodlands-texas","willow-park-texas","west-jordan-utah","charleston-west-virginia"],"enrichment":{"headline":"Phase 2: testing Remigromig for Neovascular Age-Related Macular Degeneration (NVAMD)","inPlainEnglish":"EYE-RES-104 is a randomly assigned, dose-masked study of intravitreal remigromig (EYE103) in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). The study will consist of 4 patient cohorts, with participants in each cohort randomly assigned (1:1) to either a low dose of remigromig via IVT or a high dose of remigromig via IVT.","whoItsFor":["Ages 18 Years to any","Key General who can join","Key Neovascular Age-related Macular Degeneration (NVAMD)-specific who can join","Be ≥ 50 years of age","Have treatment who have not tried this kind of treatment before subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) or juxtafoveal/extrafoveal CNV with foveal involvement","For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment","Key Incomplete Responder (IR) NVAMD-specific who can join","Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Remigromig, or Aflibercept 2.0 mg. The registry lists allocation as randomized. EYE-RES-104 is a randomly assigned, dose-masked study of intravitreal remigromig (EYE103) in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 55 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.150Z"},{"nctId":"NCT07206095","title":"Integrative Diagnosis for SCD and Other RADs","officialTitle":"Integrative Diagnosis of Sickle Cell Disease (SCD) and Other Rare Anemia Disorders (RADs) for Personalized Medicine","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hospital Universitari Vall d'Hebron Research Institute","sponsorClass":"OTHER","summary":"INTEGRA aims at enabling personalized medicine for RADs patients by the establishment of an integrative diagnostic approach based on deep phenotypic and genetic characterization through combining new generation methodologies.","conditions":["Sickle Cell Disease","Thalassaemia","Congenital Dyserythropoietic Anemia (CDA)","Enzyme Disorder; Anemia","Spherocytosis, Hereditary","Stomatocytosis","Hemoglobin Disorder","Anemia Due to Membrane Defect","Rare Anemia Disorders"],"keywords":["SICKLE CELL DISEASE","RARE ANEMIA DISORDERS","PERSONALIZED MEDICINE","DIAGNOSIS","EKTACYTOMETRY","registry"],"interventions":[{"type":"GENETIC","name":"Analysis of genetic modifiers"},{"type":"DIAGNOSTIC_TEST","name":"Disease phenotyping"}],"enrollment":350,"startDate":"2020-11-13","completionDate":"2028-12","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients sustaining a confirmed or suspected diagnosis of an hereditary rare hemolytic anemia:\n\nSickle cell disease (SCD) Thalassaemia syndromes Congenital dyserythropoietic anaemia (CDA) Enzymopathies Unstable haemoglobin / altered oxygen affinity Hereditary stomatocytosis Hereditary pyropoikilocytosis\n\nHereditary spherocytosis (HS), either severe (baseline Hb \\<10 g/dL or transfusion-dependent) or with an inconclusive diagnosis:\n\nPatient with chronic haemolytic anaemia and a compatible red cell smear, but with:\n\nEMA binding test: inconclusive or negative Genetic testing: no definitive diagnosis (VUS or no findings)\n\nExclusion Criteria:\n\n* Carrier traits in autosomal recessive hereditary anemias","locations":[{"facility":"Hospital de la Santa Creu i Sant Pau","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sant Joan de Déu","city":"Esplugues de Llobregat","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitari Gregorio Marañón","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mar Mañú Pereira PhD","phone":"+34 93 489 4063","email":"mar.manu@vhir.org"}],"primaryOutcomes":["To assess the prognostic value of LoRRca ektacytometry as biomarker providing information of SCD/RADs patients severity"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["barcelona-spain","esplugues-de-llobregat-spain","madrid-spain"],"enrichment":{"headline":"Not a traditional drug phase: Analysis of genetic modifiers for Sickle Cell Disease","inPlainEnglish":"INTEGRA aims at enabling personalized medicine for RADs patients by the establishment of an integrative diagnostic approach based on deep phenotypic and genetic characterization through combining new generation methodologies.","whoItsFor":["Patients sustaining a confirmed or suspected diagnosis of an hereditary rare hemolytic anemia:","Sickle cell disease (SCD) Thalassaemia syndromes Congenital dyserythropoietic anaemia (CDA) Enzymopathies Unstable haemoglobin / altered oxygen affinity Hereditary stomatocytosis Hereditary pyropoikilocytosis","Hereditary spherocytosis (HS), either severe (baseline Hb \\<10 g/dL or transfusion-dependent) or with an inconclusive diagnosis:","Patient with chronic haemolytic anaemia and a compatible red cell smear, but with:","EMA binding test: inconclusive or negative Genetic testing: no definitive diagnosis (VUS or no findings)"],"whoShouldSkip":["Carrier traits in autosomal recessive hereditary anemias"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 350 people at 4 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.831Z"},{"nctId":"NCT07206225","title":"A Study to Learn About the Study Medicine PF-08052667 in People With Bladder Cancer","officialTitle":"A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTITUMOR ACTIVITY OF PF-08052667 AS A SINGLE AGENT AND IN COMBINATION THERAPY IN PARTICIPANTS 18 YEARS OF AGE AND OLDER WITH BLADDER CANCER","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab.\n\nThis study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow. It includes people whose cancer has come back or hasn't gone away after receiving standard treatments like BCG. It may also include people who, based on their doctor's opinion, cannot receive standard treatments or those treatments are not available to them.\n\nThe study has three parts:\n\n* Part 1 (monotherapy dose escalation) will test PF-08052667 as a single-agent at increasing dose levels in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 2 (combination dose escalation) will test PF-08052667 in combination with BCG and/or sasanlimab (fixed dose) in participants with certain bladder cancer whose disease has worsened on or after standard treatments.\n* Part 3 (dose optimization and expansion) will further test PF-08052667 as a single agent or in combination with BCG and/or sasanlimab, at the dose(s) based on findings from Part 1 and Part 2 in participants with certain bladder cancer including those who has never received standard treatments.\n\nAll participants will receive the study drug PF-08052667. Only participants in Part 2 and Part 3 of the study will also receive BCG and/or sasanlimab. PF-08052667 will be given as an intravesical infusion, which means it will be injected directly into the bladder. Sasanlimab will be given as a subcutaneous injection, which means it will be injected under the skin.\n\nFor all parts, treatment with study medicines will continue until either a participant has decided to stop taking part in the study or is asked to leave the study for various reasons or up to about 2 years, whichever occurs first. Duration of trial participation for each participant will vary as long-term follow-up will continue after treatment discontinuation until loss to-follow-up or death, or until the study is stopped by the sponsor.","conditions":["Non-muscle Invasive Bladder Cancer"],"keywords":["NMIBC","Non-Muscle Invasive Bladder Cancer","Bladder Cancer","Bladder Tumors","Bladder Neoplasms","Malignant Tumor of Urinary Bladder","Urinary Bladder Cancer","Cancer of Bladder"],"interventions":[{"type":"DRUG","name":"PF-08052667"},{"type":"DRUG","name":"Sasanlimab"},{"type":"DRUG","name":"BCG"},{"type":"DRUG","name":"PF-02921367"}],"enrollment":294,"startDate":"2025-11-06","completionDate":"2030-01-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\n1. 18 years of age or older (or the minimum age of consent per local regulations)\n2. Histological diagnosis of high-risk, non-muscle invasive urothelial carcinoma of the bladder defined according to the WHO grading system as carcinoma in situ (CIS), with or without concurrent T1/Ta papillary disease. Note: High-grade T1/Ta papillary disease, in the absence of CIS, may be eligible for certain cohorts in Part 2 and 3\n3. BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy.\n4. Have refused or are ineligible or not appropriate for radical cystectomy\n5. Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment\n6. ECOG PS 0 or 1\n\nEXCLUSION CRITERIA:\n\n1. Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed\n2. Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol\n3. Participants with active, uncontrolled infection as specified in the protocol","locations":[{"facility":"The Kirklin Clinic of UAB Hospital","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UAB Infusion Therapy Extended Care Clinic (ECC)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Alabama at Birmingham Investigation Drug Services Pharmacy","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center at SouthShore","city":"Ruskin","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center - International Plaza","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center - McKinley Campus","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt McKinley Hospital","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center at Wesley Chapel","city":"Wesley Chapel","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Children's Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University - Feinberg School of Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Health Care","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas - Clinical Research Center","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Hospital Cambridge North Tower A","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Hospital","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Medical Center Medical Office Building","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Hospital - Indian Creek Campus","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Kansas Cancer Center - Westwood","city":"Westwood","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Basking Ridge","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Monmouth","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Bergen","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Commack","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Westchester","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center 53rd street","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"64th Street Outpatient and Innovation Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center - Main Campus","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sidney Kimmel Center for Prostate and Urological Cancers - Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Upstate Specialty Services at Harrison Center","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Medical University","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Medical University-Community Campus","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MSK Nassau","city":"Uniondale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biorepository and Precision Pathology Center (BRPC)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Institute","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Substrate Services Core Research Support (SSCRS)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Strand Medical Center","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AUC Urologists, LLC","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Urologic Research Center, LLC","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Parkway Surgery Center","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Coastal Eye Group","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Associates, P.C.","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center Outpatient Building","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center - West Campus Building","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center - William P Clements Jr University Hospital","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center-William P. Clements Imaging Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist M&S Imaging (Medical Center)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA Clinical Trials","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCOA Eye Associates","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"VAL DE Marne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pitie Salpetriere University Hospital","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center","city":"Petah Tikva","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"Central District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"Northern District","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul Teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"Seoul-teukbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Teaching Hospitals NHS Foundation Trust","city":"Sheffield","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Hallamshire Hospital","city":"Sheffield","state":"South Yorkshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Sheffield","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weston Park Cancer Centre","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of participants with dose limiting toxicities (DLTs) in dose escalation in Part 1 and Part 2 participants only","Number of participants with adverse events (AEs) in Part 1 and Part 2 participants only","Number of participants with laboratory abnormalities in Part 1 and Part 2 participants only","Recurrence-free survival (RFS) in Part 3 participants only","Event-free survival (EFS) in Part 3 participants only"],"hasResults":false,"conditionSlugs":["bladder-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","ruskin-florida","tampa-florida","wesley-chapel-florida","atlanta-georgia","chicago-illinois","iowa-city-iowa","fairway-kansas","kansas-city-kansas","overland-park-kansas","westwood-kansas","basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","syracuse-new-york","uniondale-new-york","durham-north-carolina","myrtle-beach-south-carolina","nashville-tennessee","dallas-texas","san-antonio-texas","villejuif-france","paris-france","petah-tikva-israel","ramat-gan-israel","jerusalem-israel","haifa-israel","seoul-south-korea","madrid-spain","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 1: testing PF-08052667 for Non-muscle Invasive Bladder Cancer","inPlainEnglish":"This study wants to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab. This study is for adults who have a type of bladder cancer that hasn't spread into the muscle layer of the bladder but is more likely to come back or grow.","whoItsFor":["Ages 18 Years to any","18 years of age or older (or the minimum age of consent per local regulations)","BCG unresponsive and BCG-exposed cohorts should have persistent or recurrent disease after receiving at least 5 out of 6 doses of the BCG induction therapy","Have refused or are ineligible or not appropriate for radical cystectomy","Tissue Requirement: Available tumor tissue within the last 6 months. On-treatment tumor biopsy is optional, unless mandated based on emerging data, or participating in the Biomarker Cohort, or for disease assessment"],"whoShouldSkip":["Concomitant anti-cancer therapy for Non-Muscle Invasive Bladder Cancer (NMIBC); and prior radiation therapy to the bladder are not allowed","Renal or hepatic impairment; and hematologic abnormalities as defined in the protocol","Participants with active, uncontrolled infection as specified in the protocol"],"whatHappens":"If you join, the listed intervention(s) are PF-08052667, Sasanlimab, or BCG. The registry lists allocation as na. This study wants to learn how a new medicine called PF-08052667 works when used by itself or together with another medicine called Bacillus Calmette Guerin (BCG), and/or a medicine called sasanlimab.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 294 people at 69 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.302Z"},{"nctId":"NCT07206498","title":"A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLC","officialTitle":"A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of WSD0922-FU in Combination With Osimertinib for Patients With Locally Advanced or Metastatic Non- Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Wayshine Biopharm, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation","conditions":["Non Small Cell Lung Cancer (NSCLC)"],"keywords":["WSD0922","WSD0922-FU","NSCLC","CNS metastasis","Brain metastasis","EGFR","C797S","Del19","L858R"],"interventions":[{"type":"DRUG","name":"Osimertinib (Tagrisso®)"},{"type":"DRUG","name":"WSD0922-FU"}],"enrollment":48,"startDate":"2025-10-17","completionDate":"2028-10-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥Age 18, gender is not limited;\n* Locally advanced or metastatic NSCLC confirmed by pathology;\n* Patients who have been genetically tested to carry EGFR sensitive mutations;\n* Blood/Tissue samples must be provided for testing;\n* Must have a minimum life expectancy of \\>= 3 months;\n* At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.\n* Physical Status (ECOG PS) score was 0-1;\n* Have full organ function;\n* Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;\n* Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.\n\nExclusion Criteria:\n\n* Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.\n* Have previously received more than two EGFR-TKI inhibitors for part A;\n* Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.\n* Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs.\n* Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).\n* Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.\n* History of severe allergies, or allergies to any active or inactive ingredients of the study drug;\n* Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;\n* Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);\n* Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .\n* Patients with interstitial lung disease.\n* History of severe cardiovascular diseases.\n* Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher; Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).\n* Known alcohol or drug dependence.\n* Mental disorders or poor compliance;\n* Pregnant or lactating women;\n* The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.","locations":[{"facility":"Fujian Cancer Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University Cancer Institute and Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"lily Liu, MD","phone":"+8613818880308","email":"lily.liu@wayshinebiopharm.com"},{"name":"Wei Zhong, PhD","phone":"1-951-547-4692","email":"wei.zhong@wayshinebiopharm.com"}],"primaryOutcomes":["PartA: To evaluate the safety of WSD0922-FU combined with Osimertinib in patients with NSCLC","PartB: To evaluate the efficacy of WSD0922-FU combined with Osimertinib in patients with NSCLC"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["fuzhou-china","tianjin-china","shanghai-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Osimertinib (Tagrisso®) for Non Small Cell Lung Cancer (NSCLC)","inPlainEnglish":"This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation","whoItsFor":["Ages 18 Years to any","≥Age 18, gender is not limited;","Locally advanced or metastatic NSCLC confirmed by pathology;","Patients who have been genetically tested to carry EGFR sensitive mutations;","Blood/Tissue samples must be provided for testing;","Must have a minimum life expectancy of \\>= 3 months;","At least one measurable tumor lesion according to RECIST version 1.1; ● Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions","Physical Status (ECOG PS) score was 0-1;"],"whoShouldSkip":["Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug","Have previously received more than two EGFR-TKI inhibitors for part A;","Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period","Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drugs","Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds","History of severe allergies, or allergies to any active or inactive ingredients of the study drug;","Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib (Tagrisso®), or WSD0922-FU. The registry lists allocation as randomized. This is a Phase I/II, Open Label Study of WSD0922-FU in Combination with Osimertinib for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose disease has progressed with third-generation EGFR-TKI with C797S mutation or is newly diagnosed with CNS metastasis with EGFR Del19 or L858R mutation","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 48 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.706Z"},{"nctId":"NCT07207148","title":"People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists","officialTitle":"People With Multiple Sclerosis Treated With Ocrelizumab and GLP-1 Agonists","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not.\n\nFor Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.\n\nFor Aim 2, the clinical trial, PIRA will be measured pre-GLP-1 start and at study end (week 72). A composite score of disability, similar to the ORATORIO13 trial will be constructed including EDSS score, 25-foot timed walk, 9-hole peg test, and SDMT score.","conditions":["Multiple Sclerosis"],"keywords":["Ocrelizumab","GLP-1","Obesity","Weight loss","Progressive MS","Multiple sclerosis","Biomarkers","Weight","Overweight","Neuroprotection","Semaglutide","glucagon-like peptide-1"],"interventions":[{"type":"DRUG","name":"GLP-1"},{"type":"DRUG","name":"Ocrelizumab (US)"}],"enrollment":100,"startDate":"2025-11-15","completionDate":"2028-04-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist,\n* Adult age 18-70 years,\n* BMI \\>=24.0 kg/m2,\n* Taken at least one dose of Ocrelizumab prior to study entry,\n* EDSS \\<7.0,\n* Able to provide individual informed consent,\n* MRI available to confirm the diagnosis of MS.\n\nExclusion Criteria:\n\n* Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,\n* Current clinical trial participant,\n* Unable to speak a language for which translation can be found in the hospital system,\n* Unclear documentation of MS diagnosis or prior or current MS treatment,\n* Relapse within the past 3 months,\n* Recent major surgical procedure in the past 6 months,\n* Exposure to steroids (systemic) within the past 3 months,\n* Not on Ocrelizumab in the past \\>9 months,\n* Moribund status,\n* Underweight or experiencing protein malnutrition,\n* Unable to provide consent voluntarily due to reasons of capacity or other reasons (e.g. incarcerated, dementia, etc.),\n* Unable to complete the study activities for any reason as deemed by the study investigator.\n\nAdditional Inclusion Criteria Aim 1:\n\n* Exposed to GLP-1 agonist treatment in the last 3 years or less, or starting on a GLP-1 agonist in the coming \\<3 months,\n* Willing to report monthly patient-reported outcomes remotely or in-person.\n\nAdditional Inclusion Criteria Aim 2:\n\n* Able to present for baseline and follow up in person,\n* Unexposed to a GLP-1 agonist in the past year,\n* Starting on a GLP-1 agonist in the next \\<6 months,\n* Plan to be exposed to GLP-1 agonist for a minimum of 72 weeks following enrollment.","locations":[{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dylan Rice, BA","phone":"240-362-4800","email":"dylan.rice@northwestern.edu"},{"name":"Caroline Gebczak, BS","phone":"630-313-0470","email":"caroline.gebczak@northwestern.edu"}],"primaryOutcomes":["PIRA"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","obesity"],"drugSlugs":["semaglutide","ocrelizumab"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: testing GLP-1 for Multiple Sclerosis","inPlainEnglish":"The primary outcome measure is PIRA (progression independent of relapse activity), based primarily on clinical assessment, dichotomized as present or not. For Aim 1, the cohort, patient-derived disability status (PDDS) score, and ambulation score (self-reported) will be the primary endpoints of interest.","whoItsFor":["Ages 18 Years to 70 Years","Diagnosis of MS (2019 revised McDonald criteria) of any type (PPMS, RRMS, SPMS) by a neurologist,","Adult age 18-70 years,","Taken at least one dose of Ocrelizumab prior to study entry,","MRI available to confirm the diagnosis of MS"],"whoShouldSkip":["Prior exposure to Mavenclad, Lemtrada, Cyclophosphamide, stem cell transplant or related bone marrow suppressive treatment,","Current clinical trial participant,","Unable to speak a language for which translation can be found in the hospital system,","Unclear documentation of MS diagnosis or prior or current MS treatment,","Relapse within the past 3 months,","Recent major surgical procedure in the past 6 months,","Exposure to steroids (systemic) within the past 3 months,"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.994Z"},{"nctId":"NCT07210112","title":"Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)","officialTitle":"Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Centre Hospitalier St Anne","sponsorClass":"OTHER","summary":"Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.\n\nThe benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed. Moreover, the role of 5-HT2A receptors, involved in the psychedelic experience, on the therapeutic efficacy of psilocybin is still poorly understood. For example, pre-administration of trazodone, a 5-HT2A antagonist antidepressant, could annihilate the acute subjective effects of psilocybin without altering its beneficial effects (Rosenblat et al., 2023). We intend to test this hypothesis by comparing, in a randomized, double-blind, placebo-controlled study, the effect of two possible doses of trazodone (total or partial occupancy of 5-HT2A receptors) on the benefit/risk ratio of psilocybin.\n\nWe hypothesize that the therapeutic effects of psilocybin are partially independent of 5-HT2A receptor activation and thus persist even after total or partial neutralization of its acute subjective effects.","conditions":["Depression - Major Depressive Disorder","Treatment-resistant Depression (TRD)"],"keywords":["psilocybin","trazodone","TRD","RCT"],"interventions":[{"type":"DRUG","name":"Psilocybin 25 mg per os"},{"type":"DRUG","name":"Trazodone 5mg"},{"type":"DRUG","name":"Trazodone 30 mg"},{"type":"DRUG","name":"Placebo of psilocybin"},{"type":"DRUG","name":"Placebo of trazodone"}],"enrollment":112,"startDate":"2026-06-30","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient with major depressive episode without psychotic features according to DSM-5 criteria;\n* Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ);\n* MADRS ≥ 20;\n* Written signed informed consent;\n* Patient covered by the social security system.\n\nExclusion Criteria:\n\nPsychiatric comorbidities known from medical history or identified during inclusion assessment:\n\n* Bipolar disorder;\n* Schizophrenia and psychosis;\n* Personal or family history of psychotic disorder;\n* History of personality disorder;\n* Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders;\n* Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment;\n* Significant suicide risk, as defined by: (a) suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline (b) demonstrating suicidal behaviors in the past six months, or; (c). clinical assessment of significant suicidal risk or risk of self-injury during participant interview;\n* Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD;\n\nComorbidities or somatic specificities:\n\n* Pregnancy and breastfeeding women;\n* Cardiovascular history (myocardial infarction, stroke, heart rhythm disorder, uncontrolled hypertension, QT interval prolongation, tachycardia and poor cardiovascular health);\n* Uncontrolled diabetes;\n* Uncontrolled thyroid disorder;\n* Epilepsy;\n* Parkinson's disease treated by selegiline or levodopa;\n* HIV treated by ritonavir and indinavir;\n* Active infection treated by erythromycin;\n* Fungal infection treated by ketoconazole and itraconazole;\n* Contraindications to MRI;\n\nConcomitant therapies:\n\n* 5-HT antagonist treatment2A (including quetiapine, olanzapine, aripiprazole);\n* Lithium treatment;\n* Treatment with buprenorphine or opioids, clonidine, methyldopa, digoxin, Monoamine oxidase inhibitors (MAOI), aldehyde dehydrogenase (ALDH) inhibitors and alcohol dehydrogenase (ADH) inhibitors, St. John's Wort, or warfarin should be discontinued completely before study drug administration;\n* Use of electroconvulsive therapy and/or transcranial magnetic stimulation, during the current depressive episode; or lifetime vagus nerve stimulation, deep brain stimulation, and/or ablative neurosurgery;\n* Use of psychedelics (psilocybin, lysergic acid, ayahuasca, mescaline and derivatives) during current episode;\n\nLegal status:\n\n* Persons deprived of their liberty by judicial or administrative decision, persons under compulsory psychiatric care;\n* Persons under legal protection or unable to give consent;\n\nOther:\n\n\\- Any clinical manifestation which, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study.","locations":[{"facility":"GHU Paris Psychiatrie and Neurosciences","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lucie BERKOVITCH, MD","phone":"+33 145657481","email":"l.berkovitch@ghu-paris.fr"}],"primaryOutcomes":["Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["paris-france"],"enrichment":{"headline":"Phase 2: testing Psilocybin 25 mg per os for Depression - Major Depressive Disorder","inPlainEnglish":"Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects. The benefit-risk ratio of psilocybin in treatment-resistant depression seems favorable, but needs to be confirmed.","whoItsFor":["Ages 18 Years to any","Patient with major depressive episode without psychotic features according to DSM-5 criteria;","Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ);","Patient covered by the social security system"],"whoShouldSkip":["Psychiatric comorbidities known from medical history or identified during inclusion assessment:","Schizophrenia and psychosis;","Personal or family history of psychotic disorder;","History of personality disorder;","Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders;","Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment;","Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD;"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 25 mg per os, Trazodone 5mg, or Trazodone 30 mg. The registry lists allocation as randomized. Psilocybin, a serotonin receptor agonist in the brain, significantly and quickly improves depressive symptoms while inducing profound acute subjective effects.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 112 people at Paris. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.101Z"},{"nctId":"NCT07210151","title":"Anatomical Navigation for Guided Electrophysiology in AFL and AFib","officialTitle":"Anatomical Navigation for Guided Electrophysiology in AFL and AFib","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"LUMA Vision Ltd.","sponsorClass":"INDUSTRY","summary":"The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).\n\nThe study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.","conditions":["Atrial Fibrillation","Atrial Flutter","Atrial Arrhythmia"],"keywords":[],"interventions":[{"type":"DEVICE","name":"VERAFEYE Anatomic Guidance System"}],"enrollment":50,"startDate":"2026-01-29","completionDate":"2026-12-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* IC1: Subject is at least 18 years of age at the time of consent\n* IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (\\*according to current international and local guidelines and per physician discretion)\n* IC3: Subject is able to understand and willing to provide written informed consent\n* IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site\n\nExclusion Criteria:\n\n* EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion\n* EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)\n* EC3: Unrecovered/unresolved Adverse Events from any previous invasive procedure\n* EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure.\n* EC5: Life expectancy less than 12 months\n* EC6: Current LA thrombus\n\nNote: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.","locations":[{"facility":"Klinicki Bolnicki Centar (KBC)","city":"Split","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Na Homolce Hospital","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"IKEM","city":"Prague","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vilnius University Hospital Santaros klinikos","city":"Vilnius","state":"","country":"Lithuania","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alisa Komleva","phone":"0894352047","email":"alisa.komleva@lumavision.com"},{"name":"Elke Sommerijns","phone":"+32 479 76 71 56","email":"Elke.sommerijns@lumavision.com"}],"primaryOutcomes":["Acute procedural success rates during the index procedure"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["split-croatia","prague-czechia","vilnius-lithuania"],"enrichment":{"headline":"Not a traditional drug phase: VERAFEYE Anatomic Guidance System for Atrial Fibrillation","inPlainEnglish":"The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall.","whoItsFor":["Ages 18 Years to any","IC1: Subject is at least 18 years of age at the time of consent","IC2: Subject is scheduled to undergo a catheter-ablation procedure to treat AFL/AF (\\*according to current international and local guidelines and per physician discretion)","IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site"],"whoShouldSkip":["EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion","EC3: Unrecovered/unresolved side effects from any previous invasive procedure","EC4: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure","EC5: Life expectancy less than 12 months","EC6: Current LA thrombus"],"whatHappens":"If you join, the listed intervention(s) are VERAFEYE Anatomic Guidance System. The registry lists allocation as na. The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.744Z"},{"nctId":"NCT07211217","title":"Time Restricted Eating (TRE) in Bipolar Disorder","officialTitle":"Time Restricted Eating (TRE) in Bipolar Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.","conditions":["Bipolar Disorder (BD)","Bipolar Disorder Depression","Overweight (BMI > 30)"],"keywords":["Time Restricted Eating"],"interventions":[{"type":"OTHER","name":"Time Restricted Eating"}],"enrollment":40,"startDate":"2026-09-01","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (aged 18-65 years)\n* Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21\n* Currently experiencing depression (i.e., PHQ-9 ≥ 10)22\n* Currently overweight (i.e., Body mass index (BMI) \\> 30 kg/m2)\n* Provides Informed Consent\n\nExclusion Criteria:\n\n1. Dietary factors:\n\n   1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)\n   2. Concurrent dietary intervention or modification unrelated to study procedures\n2. Psychiatric factors:\n\n   1. Severe depression (i.e., PHQ-9\\>20)\n   2. Experiencing manic symptoms (i.e., ASRM \\< 6)23\n   3. Active suicidal ideation (i.e., PHQ-9, item 9 \\>2)\n   4. Current alcohol/substance use disorder (as assessed with the Quick SCID)\n3. Medical factors:\n\n   1. Use of weight loss medications or supplements\n   2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months\n   3. Previous weight loss surgery\n   4. Malignancy within past 2 years\n   5. Major surgery within past 3 months\n   6. Medical instability considered to interfere with study procedures\n   7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)\n   8. Undergoing treatment for cancer\n   9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.\n4. Lifestyle and other factors:\n\n   a. Work or social schedules that would impede ability to adhere to study protocol\n5. Adherence factors:\n\n   1. Ability to adhere to study procedures","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Giuliana M Chau","phone":"16176439923","email":"gchau1@mgh.harvard.edu"}],"primaryOutcomes":["Weight Loss"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Time Restricted Eating for Bipolar Disorder (BD)","inPlainEnglish":"This is a randomly assigned controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, you would be randomly assigned to either a TRE or the wait list (1-to-1 ratio) for 8 weeks.","whoItsFor":["Ages 18 Years to 65 Years","Adults (aged 18-65 years)","Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21","Currently experiencing depression (i.e., PHQ-9 ≥ 10)22","Currently overweight (i.e., Body mass index (body-mass index (BMI)) \\> 30 kg/m2)"],"whoShouldSkip":["Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)","Concurrent dietary intervention or modification unrelated to study procedures","Psychiatric factors:","Severe depression (i.e., PHQ-9\\>20)","Experiencing manic symptoms (i.e., ASRM \\< 6)23","Active suicidal ideation (i.e., PHQ-9, item 9 \\>2)","Current alcohol/substance use disorder (as assessed with the Quick SCID)"],"whatHappens":"If you join, the listed intervention(s) are Time Restricted Eating. The registry lists allocation as randomized. This is a randomly assigned controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Boston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.725Z"},{"nctId":"NCT07213492","title":"Multimodal Intervention to Support Hospital-to-Community Transition in Bipolar Disorder","officialTitle":"A Bridge to Better Days: A Pilot Study of a Multimodal Intervention to Support the Successful Transition From Hospital to Community Care for People Living With Bipolar Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"McMaster University","sponsorClass":"OTHER","summary":"People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations. This open-label pilot trial will assess the feasibility, acceptability, and preliminary effectiveness of a structured care pathway to support the transition from hospital to community care. The intervention includes group-based psychoeducation, individual peer support, and personalized support for community healthcare providers to improve illness insight, treatment adherence, and symptom management.","conditions":["Bipolar Disorder (BD)","Psychosis"],"keywords":["Bipolar Disorder","Psychoeducation","Insight","Psychosis","Multimodal Intervention","Early-Stage Bipolar Disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Group-Based Psychoeducation"},{"type":"BEHAVIORAL","name":"Peer Support"},{"type":"BEHAVIORAL","name":"Personalized Support for Community Healthcare Provider"}],"enrollment":10,"startDate":"2026-06-01","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age: Patient-participants must be between 18 and 35 years old.\n* Diagnosis: Must have been diagnosed with bipolar disorder within the past 24 months.\n* Clinical Features: Must have experienced psychosis and/or a lack of insight into their illness at the time of enrollment.\n* Language Proficiency: Must be able to understand and speak English.\n\nExclusion Criteria:\n\n* Severe Psychiatric Conditions: Individuals with a severe psychiatric condition that would prevent them from safely engaging in the intervention.\n* Cognitive or Medical Impairment: Those with significant cognitive impairment or a medical condition that interferes with their ability to participate in psychoeducation or peer-support sessions.\n* Substance Use Disorder: Individuals with an active substance use disorder that may impact adherence to the intervention.\n* Language Barriers: Participants who do not speak English and are unable to engage in study sessions without language support.\n* Concurrent Participation in Similar Programs: Individuals who are already enrolled in another structured psychoeducational or peer-support program that could interfere with study outcomes.","locations":[{"facility":"St. Joseph's Healthcare Hamilton","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fabiano A. Gomes, MD, Ph.D.","phone":"905-522-1155","email":"gomesfs@mcmaster.ca"},{"name":"Daniela Giansante, MSc","phone":"","email":"giansand@mcmaster.ca"}],"primaryOutcomes":["Feasibility of the Multi-Modal Transitional Care Intervention","Acceptability of the Multi-Modal Transitional Care Intervention"],"hasResults":false,"conditionSlugs":["als","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["hamilton-canada"],"enrichment":{"headline":"Not a traditional drug phase: Group-Based Psychoeducation for Bipolar Disorder (BD)","inPlainEnglish":"People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment. Although clinical guidelines recommend combining medication and psychosocial support, and research shows that early intervention is associated with improved outcomes, no structured care programs currently exist for individuals in the early stages of BD, contributing to chronic illness progression and preventable hospitalizations.","whoItsFor":["Ages 18 Years to 35 Years","Age: Patient-participants must be between 18 and 35 years old","Diagnosis: Must have been diagnosed with bipolar disorder within the past 24 months","Clinical Features: Must have experienced psychosis and/or a lack of insight into their illness at the time of enrollment"],"whoShouldSkip":["Severe Psychiatric Conditions: Individuals with a severe psychiatric condition that would prevent them from safely engaging in the intervention","Cognitive or Medical Impairment: Those with significant cognitive impairment or a medical condition that interferes with their ability to participate in psychoeducation or peer-support sessions","Substance Use Disorder: Individuals with an active substance use disorder that may impact adherence to the intervention","Concurrent Participation in Similar Programs: Individuals who are already enrolled in another structured psychoeducational or peer-support program that could interfere with study outcomes"],"whatHappens":"If you join, the listed intervention(s) are Group-Based Psychoeducation, Peer Support, or Personalized Support for Community Healthcare Provider. The registry lists allocation as na. People with bipolar disorder (BD) are at high risk of relapse following hospital discharge, partly due to a lack of BD-specific expertise and resources within community services required for comprehensive treatment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Hamilton. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.746Z"},{"nctId":"NCT07213700","title":"InRAD Observational Study","officialTitle":"The International Registry for Alzheimer's Disease and Other Dementias (InRAD): An International Registry Observational Study Dedicated to Evaluating Outcomes Data in Alzheimer's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Stichting International Registry for Alzheimer's Disease and other Dementias Foundation","sponsorClass":"OTHER","summary":"The goal of this international observational study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers.\n\nThe InRAD Registry Observational Study has several aims:\n\n* To collect medical information for many years from a large group of people with Alzheimer's disease. This will be used for research, which will support improved understanding about the disease.\n* To enable researchers to look at the effectiveness, usefulness and safety of treatments for Alzheimer's disease.\n* To enable researchers to answer similar research questions and compare results in many different areas of the world.\n\nPeople with Alzheimer's disease who meet the eligibility criteria and agree to participate in the Study will be asked to visit their doctor (e.g. psychiatrist, geriatrician, or neurologist) at least once a year, or as frequently as is needed for their care. During or after their appointments they may be offered assessments, tests, medications, and treatments as determined by their doctor and their team. This is an observational data collection.","conditions":["Alzheimer's Disease(AD)","Mild Cognitive Impairment (MCI)","Subjective Cognitive Decline (SCD)","Non-Alzheimer Degenerative Dementia"],"keywords":["Alzheimer's disease (AD)","Dementia","Observational study","Real-world data (RWD)","International registry","Cognitive decline","InRAD Registry","InRAD Foundation","Cognitive screening (MoCA, MMSE)","AD-specific therapies","Clinical staging"],"interventions":[{"type":"OTHER","name":"None, this is a non-interventional observational study"}],"enrollment":50000,"startDate":"2026-03-30","completionDate":"2036-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR\n* Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),\n* Be attending an InRAD Center,\n* Have provided informed consent for long-term follow-up\n\nExclusion Criteria:\n\n-Any patient or legal representative who is unable or unwilling to provide a signed informed consent form\n\nThe protocol does not specify a lower or upper age limit. Participants are expected to be predominantly adults, and can include younger adults with early-onset or genetically determined Alzheimer's disease (e.g. Down syndrome-associated Alzheimer's disease).","locations":[{"facility":"Alfred Hospital","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of Graz","city":"Graz","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kardinal Schwarzenberg Klinikum","city":"Schwarzach","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZLeuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade da Santa Casa de São Paulo","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Motol and Homolka University Hospital (UHM)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ain Shams University","city":"Cairo","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aiginition Hospital","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Panhellenic Federation of Alzheimer's Disease and Related Disorders","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Adelaide and Meath Hospital","city":"Dublin","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"B.R.A.N.D. Center - Neurologia Universitaria - Policinico Foggia","city":"Foggia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stichting Amsterdam UMC (location VUmc) - ABOARD Cohort","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stichting Amsterdam UMC (location VUmc) - Amsterdam Dementia Cohort","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuroProtect","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Santo António","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"County Emergency Clinic Hospital Brasov/Spitalul Clinic Judetean de Urgenta Brasov","city":"Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke Hospital for Chronic Disease-Geriatrics and Gerontology II","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundatia Ana Aslan International","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"King Faisal Specialist Hospital","city":"Riyadh","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundació ACE, Institut Català de Neurociències Aplicades","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Taipei Municipal TuCheng Hospital","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul University Çapa Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Scientific Officer","phone":"","email":"office@inradnetwork.org"}],"primaryOutcomes":["Transitions in Alzheimer's Disease Clinical Stage Over Time","Change in Cognition Over Time"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["melbourne-australia","graz-austria","schwarzach-austria","leuven-belgium","s-o-paulo-brazil","prague-czechia","cairo-egypt","athens-greece","thessaloniki-greece","dublin-ireland","foggia-italy","milan-italy","amsterdam-netherlands","warsaw-poland","porto-portugal","brasov-romania","bucharest-romania","riyadh-saudi-arabia","barcelona-spain","new-taipei-city-taiwan","istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: None, this is a non-interventional observational study for Alzheimer's Disease(AD)","inPlainEnglish":"The goal of this international watch-and-measure (no experimental treatment required) study is to evaluate long-term disease outcomes and treatment safety in people with Alzheimer's disease (PwAD), by collecting real-world data from routine clinical practice across global clinical centers. The InRAD Registry watch-and-measure (no experimental treatment required) Study has several aims: * To collect medical information for many years from a large group of people with Alzheimer's disease.","whoItsFor":["Ages 18 Years to any","Be undergoing diagnostic work-up for Alzheimer's disease (AD), OR","Have a confirmed diagnosis of AD (whether currently treated with an AD-specific treatment, or untreated),","Be attending an InRAD Center,"],"whoShouldSkip":["The protocol does not specify a lower or upper age limit. Participants are expected to be predominantly adults, and can include younger adults with early-onset or genetically determined Alzheimer's disease (e.g. Down syndrome-associated Alzheimer's disease)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50,000 people at 23 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.324Z"},{"nctId":"NCT07213791","title":"A Study of LY4337713 in Participants With FAP-Positive Solid Tumors","officialTitle":"A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.","conditions":["Ovarian Neoplasms","Breast Neoplasms","Pancreatic Intraductal Neoplasms","Colorectal Neoplasms","Esophageal Neoplasms","Stomach Neoplasms","Cholangiocarcinoma","Advanced Solid Tumors"],"keywords":["Cancer-associated fibroblasts (CAF)","Lutetium-177","LuFAP","Lu-177-FAP"],"interventions":[{"type":"DRUG","name":"LY4337713"}],"enrollment":340,"startDate":"2025-10-22","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment\n* Must have histologically or cytologically confirmed diagnosis of one of the following:\n\n  * Adenocarcinoma of the pancreas\n  * Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer\n  * HER2-positive breast cancer\n  * Triple negative breast cancer (TNBC)\n  * Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)\n\n    * Gastric cancer (adenocarcinoma)\n    * Colorectal cancer (CRC)\n    * Esophageal cancer (squamous cell carcinoma or adenocarcinoma)\n    * Cholangiocarcinoma\n    * Other non- central nervous system (CNS) solid tumors, which have demonstrated FAP uptake via positron emission tomography (PET),\n* Must have received prior treatments as indicated below:\n\n  * Phase 1a\n\n    * Adenocarcinoma of the pancreas: Participants must have received at least 1, but no more than 2 prior regimens for locally advanced unresectable or metastatic disease.\n    * HR-positive HER2-negative breast cancer: Participants must have received less than or equal to (≤)5 prior lines of treatment for advanced or metastatic disease, which must include a cyclin-dependent kinase 4/6 inhibitor.\n    * HER2-positive breast cancer: Participants must have received at least 2 lines of HER2-targeted therapy, which should include at least 1 antibody-drug conjugate (ADC) for metastatic disease (if locally available).\n    * TNBC: Participants must have received at least 1 prior line of therapy for metastatic disease, and must have received an ADC unless unavailable, ineligible, or refused.\n    * Platinum-resistant or refractory ovarian cancer: Participants must have received or after at least 1 platinum-based therapy.\n    * Gastric cancer, CRC, esophageal cancer (squamous cell carcinoma or adenocarcinoma), and cholangiocarcinoma: Participants must have received greater than or equal to (≥)1 prior line of systemic therapy for advanced or metastatic disease; this may include, but does not require, prior line(s) in combination with immunotherapy or vascular endothelial growth factor inhibitor.\n    * Other non-CNS solid tumors: Participants must have exhausted, be ineligible for, or refused all standard-of-care therapy appropriate for their disease.\n  * Phase 1b:\n\n    * Participants must have advanced or metastatic solid tumors and have received ≥1 prior line of therapy.\n* Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.\n* Measured creatinine clearance ≥60 milliliters per minute (mL/min)\n\nExclusion Criteria:\n\n* Have known active central nervous system (CNS) metastases or carcinomatous meningitis.\n* Have significant cardiovascular disease\n* Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)\n* Have evidence of ongoing and untreated urinary tract obstruction\n* Had previous hemi- or total-body radiation.\n* Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)\n* Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI).","locations":[{"facility":"Hoag Memorial Hospital Presbyterian","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University Medical Center","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biogenix Molecular, LLC","city":"Miami","state":"Florida","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Moffitt","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University (IU) School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"United Theranostics","city":"Glen Burnie","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BAMF Health Inc.","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University (NYU) Clinical Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fox Chase Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW (Sammons CC)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin - Carbone Cancer Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital, Fudan University","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Essen","city":"Essen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Chiba","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kyoto University Hospital","city":"Kyoto","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis (NKI-AVL)","city":"Amsterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC - Locatie VUmc","city":"Amsterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Erasmus MC","city":"GE Rotterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Maastricht University Medical Center","city":"Maastricht","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Stichting Radboud Universitair Medisch Centrum","city":"Nijmegen","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"clinical_inquiry_hub@lilly.com","email":""}],"primaryOutcomes":["Phase 1a: Percentage of Participants with Dose Limited Toxicity (DLT) Toxicities","Phase 1b: Objective Response Rate (ORR): Percentage of Participants with Best Response of Complete Response (CR) or Partial Response (PR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["newport-beach-california","stanford-california","miami-florida","tampa-florida","indianapolis-indiana","glen-burnie-maryland","boston-massachusetts","detroit-michigan","grand-rapids-michigan","rochester-minnesota","st-louis-missouri","new-york-new-york","durham-north-carolina","philadelphia-pennsylvania","dallas-texas","houston-texas","madison-wisconsin","shanghai-china","essen-germany","chiba-japan","kyoto-japan","amsterdam-netherlands","ge-rotterdam-netherlands","maastricht-netherlands","nijmegen-netherlands","utrecht-netherlands"],"enrichment":{"headline":"Phase 1: testing LY4337713 for Ovarian Neoplasms","inPlainEnglish":"This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP).","whoItsFor":["Ages 18 Years to any","Must have clinical or imaging evidence of fibroblast activation protein (FAP) expression per local assessment","Must have histologically or cytologically confirmed diagnosis of one of the following:","Adenocarcinoma of the pancreas","Hormone receptor (HR)-positive human epidermal growth factor 2 (HER2)-negative breast cancer","HER2-positive breast cancer","Triple negative breast cancer (TNBC)","Platinum-resistant or refractory ovarian cancer (including ovarian carcinosarcoma)"],"whoShouldSkip":["Have known active central nervous system (CNS) metastases or carcinomatous meningitis","Have significant cardiovascular disease","Have prolongation of the corrected QTcF \\>470 milliseconds (msec) during screening. QTcF is calculated using Fridericia's Formula: QTcF = QT/(RR0.33)","Have evidence of ongoing and untreated urinary tract obstruction","Had previous hemi- or total-body radiation","Had previous adoptive T-cell therapy (e.g., chimeric antigen receptor T-cell \\[CAR-T therapy, T-cell receptor \\[TCR\\] therapy, etc.)","Unable to lie flat during, or otherwise tolerate, single photon emission computed tomography (SPECT), positron emission tomography (PET), computed tomography (CT) or magnetic resonance imaging (MRI)"],"whatHappens":"If you join, the listed intervention(s) are LY4337713. The registry lists allocation as randomized. This is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 340 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.983Z"},{"nctId":"NCT07214376","title":"A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","officialTitle":"A Randomized Placebo-procedure Controlled Trial of the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System PULmonary Artery Denervation Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Pulnovo Medical, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical study is to evaluate the safety and efficacy of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomized control trial will compare the investigational device (The Enhancor System) to control (medical therapy.)\n\nParticipants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.","conditions":["Pulmonary Hypertension","Heart Failure With Reduced Ejection Fraction","Hypertension","Vascular Diseases","Cardiovascular Diseases","Heart Failure","Heart Failure With Preserved Ejection Fraction","Heart Failure With Mid Range Ejection Fraction"],"keywords":["Pulmonary Artery Denervation","Pulmonary Hypertension Due to Left Heart Disease","Heart Failure","pulmonary hypertension","left heart failure"],"interventions":[{"type":"DEVICE","name":"Pulmonary Artery Denervation (PADN)"},{"type":"DEVICE","name":"Sham procedure control"}],"enrollment":750,"startDate":"2026-08-21","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject is ≥18 and ≤85 years of age\n2. Subject is diagnosed with chronic HF due to left-sided heart disease for at least 6 months prior to screening (regardless of LVEF), and remains symptomatic despite maximally tolerated class I GDMT for left heart failure and CRT as appropriate per US or EU guidelines according to region of enrollment\n3. Subject is clinically stable, defined as:\n\n   * No hospitalizations for heart failure for at least 1 month; no major changes in societal guideline-recommended class I oral GDMT for left heart failure for at least 1 month; no CRT or ICD implant in the prior 3 months; and no anticipated major changes in any HF-GDMT (other than possibly diuretic dose) or planned cardiac rhythm management device implantation after the procedure\n   * SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)\n4. PASP (RVSP) is ≥30 mmHg on the baseline TTE.\n5. Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications).\n6. Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues\n7. Subject has NT-proBNP ≥600 pg/mL for patients with LVEF ≤40% or ≥200 pg/mL for patients with LVEF \\>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)\n8. Subject is able and willing to follow all aspects of the research protocol including medication compliance and follow-up visits and testing.\n9. Subject or the subject's legally designated representative signs an IRB/EC approved informed consent form prior to study participation.\n\nExclusion Criteria:\n\n1. Subject has a life expectancy of less than 1 year due to non-cardiovascular causes.\n2. Subject has known hypertrophic cardiomyopathy with either left ventricular (LV) outflow tract obstruction or systolic anterior motion (SAM) of the anterior leaflet of the mitral valve; pericardial disease; or infiltrative or active inflammatory myocardial disease, including known amyloidosis\n3. Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve\n4. Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4\n5. Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)\n6. Subjects with a known bleeding diathesis or who will refuse blood transfusions\n7. Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation\n8. Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis\n9. Subject has congenital heart disease other than mitral valve prolapse or a PFO\n10. Subject had coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) in the prior 6 months or is anticipated to undergo CABG or PCI within 12 months after randomization.\n11. Subject has any pacemaker with an intracardiac sensing or pacing lead or wire implanted in the prior 3 months, or CardioMEMS HF System or other intracardiac pressure monitoring system, or cardiac contractility modulation system or baroreceptor activation therapy implanted within the prior 3 months, or any plans to implant any of these devices within 12 months after the procedure.\n12. Subject has undergone atrial fibrillation ablation within the prior 6 months or is anticipated to undergo atrial fibrillation ablation within 12 months after randomization.\n13. Subject has undergone heart valve surgery or transcatheter valve intervention within the prior 6 months or is anticipated to undergo heart valve surgery or transcatheter valve intervention (e.g., valve repair or replacement, valvuloplasty) within 12 months after randomization.\n14. Subject has any tricuspid or pulmonic valve implants (implanted annuloplasty rings are allowed).\n15. Subject has an inferior vena cava (IVC) filter implant.\n16. Subject has received a prior heart or heart-lung transplantation or is listed for heart or heart-lung transplantation or is anticipated to receive a ventricular assist device (VAD) implant within 6 months after randomization.\n17. Subjects with intracardiac thrombus on TTE.\n18. Subjects with pericardial effusion ≥10 mm on TTE\n19. Subject's PH is predominantly due to WHO Group 1, 3, 4, or 5. Note: Multifactorial features of PH may be present, but the predominant diagnosis must be WHO Group 2 CpcPH.\n20. Subject has been treated with any group 1 PAH-targeted drugs, including sotatercept, within the prior month or is planned to receive such therapy after randomization.\n21. Subject is anticipated to undergo any surgery within 6 months after randomization (other than minor surgeries requiring only local anesthesia).\n22. Subject has severe renal insufficiency (eGFR \\<30 mL/min/1.73m2 by the CKD-EPI formula, or on dialysis).\n23. Subject has severe liver insufficiency (Child-Pugh classification C).\n24. Subject has platelet count \\<100 × 109/L.\n25. Subject has systemic inflammatory or other disease requiring long-term use of oral glucocorticoids or immunosuppressants.\n26. Subject has active infection requiring oral or intravenous antibiotics.\n27. Subject has a body mass index (BMI) \\>45 kg/m².\n28. Subjects with severe respiratory disease, defined as any disorder of the respiratory system with diffusing capacity of the lungs for carbon monoxide (DLCO) \\<40% AND total lung capacity (TLC) \\<60% AND forced expiratory volume in one second (FEV1) \\<70% by plethysmography; OR who require ambulatory or long-term oxygen therapy\n29. Subject has known severe untreated sleep apnea. Note: Subjects with sleep apnea treated with CPAP/BiPAP for at least the prior 3 months are not excluded.\n30. Subjects with pulmonary embolism or deep vein thrombosis in the prior 6 months.\n31. Subject is a pregnant or breastfeeding woman, or a woman planning to become pregnant within one year. Women of child-bearing potential must have a negative pregnancy test within 1 week of randomization.\n32. Subject is participating in another clinical trial of an investigational drug or device that has not reached its primary endpoint.\n33. Subject has severe cachexia/frailty, substance abuse, or any other condition that the investigator believes may affect the subject's ability to comply with or complete all the study requirements including follow-up visits.\n34. Subject is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, children, impoverished persons, persons in prisons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations may also include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.","locations":[{"facility":"Banner - University Medical Center Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Hospital Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Florida - Weston","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiovascular Institute of the South","city":"Houma","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Shore University Hospital","city":"Manhasset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Morningside","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewYork-Presbyterian Hospital/Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Heart Institute","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Mechanicsburg","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lankenau Institute for Medical Research","city":"Wynnewood","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Fujian Medical University","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiamen Cardiovascular Hospital Xiamen University","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing First Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"MOFFETT LAURA MARY GINTANT","phone":"+1 952 303 2821","email":"laura.moffett@pulnovomed.com"},{"name":"Mark Gu","phone":"+08 13774217349","email":"mark.g@pulnovomed.com"}],"primaryOutcomes":["Primary Efficacy Endpoint","Primary Safety Endpoint"],"hasResults":false,"conditionSlugs":["heart-failure","hypertension"],"drugSlugs":[],"locationSlugs":["tucson-arizona","new-haven-connecticut","washington-d-c-district-of-columbia","weston-florida","houma-louisiana","boston-massachusetts","detroit-michigan","manhasset-new-york","new-york-new-york","cleveland-ohio","tulsa-oklahoma","mechanicsburg-pennsylvania","wynnewood-pennsylvania","fuzhou-china","xiamen-china","nanjing-china","jinan-china"],"enrichment":{"headline":"Not a traditional drug phase: Pulmonary Artery Denervation (PADN) for Pulmonary Hypertension","inPlainEnglish":"The goal of this clinical study is to measure the safety and how well it works of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD). This randomly assigned control trial will compare the investigational device (The Enhancor System) to control (medical therapy.) Participants who will consist of patients with chronic heart failure (HF) who are receiving maximally tolerated guideline-directed medical therapy (GDMT) for left heart failure, are clinically stable, and who have been diagnosed with CpcPH by right heart catheterization (RHC), will be treated with PADN and followed for 3 years.","whoItsFor":["Ages 18 Years to 85 Years","Subject is ≥18 and ≤85 years of age","Subject is clinically stable, defined as:","SBP is ≥90 and ≤160 mmHg and resting HR is ≥50 and ≤100 bpm (≤110 bpm for atrial fibrillation)","PASP (RVSP) is ≥30 mmHg on the baseline TTE","Subject has New York Heart Association (NYHA) class II, III or IVa symptoms (IVa is defined as symptoms with minimal exertion or at rest, but the patient is able to ambulate and does not require continuous intravenous medications)","Subject has 6MWD at baseline ranging from 100 to 450 m limited by dyspnea or fatigue and not orthopedic or other non-HF-related issues","Subject has NT-proBNP ≥600 pg/mL for patients with LVEF ≤40% or ≥200 pg/mL for patients with LVEF \\>40% at the time of screening (a central lab will be made available for sites that cannot measure NT-proBNP)"],"whoShouldSkip":["Subject has a life expectancy of less than 1 year due to non-cardiovascular causes","Subject has severe stenosis or regurgitation of any heart valve, moderate or severe stenosis of the aortic valve, or any degree of stenosis of the pulmonic valve","Subject has symptomatic carotid stenosis, or transient ischemic attack (TIA) or stroke in the prior 30 days or any prior stroke with a permanent residual deficit with modified Rankin Scale (mRS) score ≥4","Subject has any prior intracranial hemorrhage with or without a residual deficit, or any known intracranial pathology pre-disposing to bleeding (e.g. mass, AV fistula, aneurysm, etc.)","Subjects with a known bleeding diathesis or who will refuse blood transfusions","Subjects allergic to heparin (including heparin induced thrombocytopenia), unless bivalirudin or argatroban can be used for procedural anticoagulation","Subjects with life threatening allergy to contrast dye that cannot be adequately pre-medicated, or any prior contrast-related anaphylaxis"],"whatHappens":"If you join, the listed intervention(s) are Pulmonary Artery Denervation (PADN), or Sham procedure control. The registry lists allocation as randomized. The goal of this clinical study is to measure the safety and how well it works of percutaneous pulmonary artery denervation with the Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor System in patients with combined pre- and post-capillary pulmonary hypertension (CpcPH) associated with left heart disease (LHD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 750 people at 19 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.425Z"},{"nctId":"NCT07214545","title":"External Trigeminal Nerve Stimulation for Children With ASD + ADHD to Reduce Elevated Symptoms","officialTitle":"Phase IIa Clinical Trial of External Trigeminal Nerve Stimulation for Autistic Children With Attention Deficit/Hyperactivity Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the efficacy and tolerability of the eTNS device. The main questions it aims to answer are:\n\n* Does eTNS reduce ADHD symptoms?\n* Does eTNS improve core and associated features of ASD?\n\nParticipation spans 8-12 weeks and includes:\n\n* 4-5 in-person visits\n* 4 brief virtual check-ins\n* Nightly use of the eTNS device with a small sticky patch applied to child's forehead\n* Randomized assignment (those who start with the sham device may try the active device later)","conditions":["Attention Deficit Disorder With Hyperactivity (ADHD)","Autism Spectrum Disorder (ASD)"],"keywords":["eTNS","external trigeminal nerve stimulation","eTNS CARES"],"interventions":[{"type":"DEVICE","name":"Trigeminal Nerve Stimulation"},{"type":"DEVICE","name":"Sham Trigeminal Nerve Stimulation"}],"enrollment":60,"startDate":"2025-10-06","completionDate":"2027-09","sex":"ALL","minAge":"7 Years","maxAge":"14 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism Diagnostic Interview-Revised (ADI-R)\n* IQ \\> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)\n* Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \\> 24\n* Stable on current medications for a minimum of 4 weeks before baseline\n* Ability to complete protocol testing\n* Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English.\n\nExclusion Criteria:\n\n* Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm\n* History of moderate to severe coarse brain injury\n* Active medical illness expected to interfere with study assessments\n* Presence of implanted stimulator (e.g., vagal nerve stimulator)\n* Active dermatologic condition likely to interfere with eTNS electrode wearability\n* Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician\n* Inability to communicate discomfort or pain\n* Current and anticipated continued use of antipsychotic or stimulant medication","locations":[{"facility":"UCSF Nancy Friend Pritzker Psychiatry Building","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in ADHD Symptoms"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Not a traditional drug phase: Trigeminal Nerve Stimulation for Attention Deficit Disorder With Hyperactivity (ADHD)","inPlainEnglish":"The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD). It will also learn about the how well it works and tolerability of the eTNS device.","whoItsFor":["Ages 7 Years to 14 Years","Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism Diagnostic Interview-Revised (ADI-R)","IQ \\> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI)","Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \\> 24","Stable on current medications for a minimum of 4 weeks before baseline","Ability to complete protocol testing","Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English"],"whoShouldSkip":["Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm","History of moderate to severe coarse brain injury","Active medical illness expected to interfere with study assessments","Presence of implanted stimulator (e.g., vagal nerve stimulator)","Active dermatologic condition likely to interfere with eTNS electrode wearability","Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician","Inability to communicate discomfort or pain"],"whatHappens":"If you join, the listed intervention(s) are Trigeminal Nerve Stimulation, or Sham Trigeminal Nerve Stimulation. The registry lists allocation as randomized. The goal of this clinical trial is to learn if external trigeminal nerve stimulation (eTNS) works to treat ADHD symptoms in children on the autism spectrum (ASD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at San Francisco. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.652Z"},{"nctId":"NCT07214636","title":"Development and Investigation of the ApneaTheraPlay","officialTitle":"Development and Investigation of the Effectiveness of a Digital Video-Based Game Exercise System (ApneaTheraPlay) for Individuals With Obstructive Sleep Apnea Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Medipol University","sponsorClass":"OTHER","summary":"Obstructive Sleep Apnea Syndrome (OSAS) is commonly treated with CPAP devices, but adherence rates are low. Exercise has been shown to strengthen respiratory muscles, improve upper airway function, and enhance sleep quality. However, most studies have examined only single or dual exercise protocols, and there is little evidence regarding integrated programs with four exercise types or their effects when performed directly before sleep.\n\nThis project aims to develop and evaluate ApneaTheraPlay (ATP), a digital gamified video-based exercise platform combining respiratory, aerobic, strengthening, and oropharyngeal exercises. The randomized controlled, double-blind study will allocate participants into three groups: ATP, a structured pre-sleep exercise group (SPEG), and a control group (CG). Intervention groups will exercise three times per week for 12 weeks, while the control group will only keep a physical activity diary.","conditions":["Apnea, Obstructive","Exercise Addiction","Physiotherapy and Rehabilitation"],"keywords":["Apnea","Exercise","Exergame","Physiotherapy and Rehabilitation","CPAP"],"interventions":[{"type":"BEHAVIORAL","name":"Structured Pre-Sleep Exercise"},{"type":"BEHAVIORAL","name":"ApneaTheraPlay (ATP)"}],"enrollment":54,"startDate":"2026-09-23","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 18-65 years of age\n* Individuals diagnosed with mild, moderate, or severe OSAS (AHI 5-30 events/hour) based on laboratory diagnostic polysomnography assessments\n* Individuals diagnosed by a pulmonologist within the last year and who have started CPAP therapy for at most 12 months and who are regular users\n* Those with habitual snoring\n* All participants in the exercise group must have or have access to a phone, tablet, or computer compatible with SMART technologies using the exercise system app\n* Participants must have sufficient physical function to follow the exercise instructions\n* Familiarity with mobile health applications, as assessed by the VAS, and a willingness to participate in these exercises of \\>7\n* Not having participated in physiotherapy-based interventions targeting OSAS in the last 3 months\n* A score of 68 or higher on the System Usability Scale (SUS)\n\nExclusion Criteria:\n\n* • BMI \\> 40 kg/m2\n\n  * Serious drug or alcohol abuse\n  * Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns or exercise performance\n  * Pregnancy or postpartum (\\<6 months) due to hormonal effects on sleep and respiratory function\n  * Any medical contraindication to physical activity (unstable coronary disease, decompensated heart failure) according to the American College of Sports Medicine (ACSM) exercise guidelines (American College of Sports Medicine, 2021)\n  * History of stroke\n  * Presence of any significant respiratory, neuromuscular, or other disorder causing hypercapnia\n  * Systemic disease associated with an inflammatory entity (e.g., arthritis, sarcoidosis, vasculitis, lupus)\n  * Craniofacial deformity\n  * Presence of secondary respiratory diseases such as severe upper airway obstruction or COPD\n  * Presence of dysphagia\n  * Presence of a frenulum restricting tongue movement","locations":[{"facility":"Istanbul Medipol Universty","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gülay Aras Bayram, PhD","phone":"05054966284","email":"garas@medipol.edu.tr"},{"name":"Gülay Aras Bayram","phone":"05054966284","email":"garas@medipol.edu.tr"}],"primaryOutcomes":["Apnea-hypopnea index (AHI)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Structured Pre-Sleep Exercise for Apnea, Obstructive","inPlainEnglish":"Obstructive Sleep Apnea Syndrome (OSAS) is commonly treated with CPAP devices, but adherence rates are low. Exercise has been shown to strengthen respiratory muscles, improve upper airway function, and enhance sleep quality.","whoItsFor":["Ages 18 Years to 65 Years","Individuals diagnosed with mild, moderate, or severe OSAS (AHI 5-30 events/hour) based on laboratory diagnostic polysomnography assessments","Individuals diagnosed by a pulmonologist within the last year and who have started CPAP therapy for at most 12 months and who are regular users","Those with habitual snoring","All participants in the exercise group must have or have access to a phone, tablet, or computer compatible with SMART technologies using the exercise system app","Participants must have sufficient physical function to follow the exercise instructions","Familiarity with mobile health applications, as assessed by the VAS, and a willingness to participate in these exercises of \\>7","Not having participated in physiotherapy-based interventions targeting OSAS in the last 3 months"],"whoShouldSkip":["Serious drug or alcohol abuse","Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns or exercise performance","Pregnancy or postpartum (\\<6 months) due to hormonal effects on sleep and respiratory function","Any medical contraindication to physical activity (unstable coronary disease, decompensated heart failure) according to the American College of Sports Medicine (ACSM) exercise guidelines (American College of Sports Medicine, 2021)","Presence of any significant respiratory, neuromuscular, or other disorder causing hypercapnia","Systemic disease associated with an inflammatory entity (e.g., arthritis, sarcoidosis, vasculitis, lupus)","Craniofacial deformity"],"whatHappens":"If you join, the listed intervention(s) are Structured Pre-Sleep Exercise, or ApneaTheraPlay (ATP). The registry lists allocation as randomized. Obstructive Sleep Apnea Syndrome (OSAS) is commonly treated with CPAP devices, but adherence rates are low.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 54 people at Istanbul. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.951Z"},{"nctId":"NCT07215195","title":"Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury","officialTitle":"Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Oxford","sponsorClass":"OTHER","summary":"The two most common causes of brain injury are stroke and trauma. Both sleep and mental health problems are common after brain injury; we will investigate whether there is a relationship between poor sleep quality and worse mental health in this group. We will also follow patients up, at approximately three-monthly intervals until one year after injury, to see how sleep and mental health symptoms change over time and with recovery.\n\nWe will assess sleep in detail using questionnaires, a sleep monitor worn on the wrist, a portable brain activity sensor, and a sleep mat. We will assess mental health (neuropsychiatric) symptoms using questionnaires.\n\nParticipants will be asked to complete these assessments at baseline and at approximately 3-monthly intervals until they reach 12 months post-injury.\n\nThis data will allow us to explore the types of sleep disruption seen after brain injury and examine the association between sleep and mental health symptoms.","conditions":["Acquired Brain Injury (Including Stroke)"],"keywords":["stroke","traumatic brain injury","neuropsychiatric disorder","movement","sleep","brain injury"],"interventions":[],"enrollment":150,"startDate":"2025-10-10","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to give informed consent for participation in the study.\n* Aged 18 years or above.\n* At least one week, but less than 12 months post-injury\n* Clinical diagnosis of acquired brain injury (stroke, haemorrhage or traumatic).\n* Participants with Traumatic Brain Injury will have a Mild (probable) or Moderate-severe (definite) brain injury according to the Mayo classification\n* Participants must be willing to consent to us contacting their general practitioner (GP) or direct care team if we have concerns about their mental health\n\nExclusion Criteria:\n\n* Brain injury not caused by trauma, haemorrhage or stroke\n* Previous brain injury.\n* Other relevant neurological conditions which could affect outcome measures (e.g., Parkinson's or Alzheimer's disease)\n* No stable and suitable place to sleep","locations":[{"facility":"Oxford Centre for Integrative Neuroimaging (WIN) FMRIB, Nuffield Department of Clinical Neurosciences, John Radcliffe Hospital, Oxford OX3 9DU","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melanie Fleming, PhD","phone":"00 44 1865 611 461","email":"melanie.fleming@ndcn.ox.ac.uk"},{"name":"Brent Elliott, MBBBS MSc","phone":"00 44 7967 418523","email":"brent.elliott@keble.ox.ac.uk"}],"primaryOutcomes":["Neuropsychiatric (mental health) symptoms at baseline","Self reported sleep quality at baseline"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Neuropsychiatric Outcomes and Disrupted Sleep Following Acquired Brain Injury","inPlainEnglish":"The two most common causes of brain injury are stroke and trauma. Both sleep and mental health problems are common after brain injury; we will see if there is a relationship between poor sleep quality and worse mental health in this group.","whoItsFor":["Ages 18 Years to any","Aged 18 years or above","At least one week, but less than 12 months post-injury","Clinical diagnosis of acquired brain injury (stroke, haemorrhage or traumatic)","Participants with Traumatic Brain Injury will have a Mild (probable) or Moderate-severe (definite) brain injury according to the Mayo classification","Participants must be willing to consent to us contacting their general practitioner (GP) or direct care team if we have concerns about their mental health"],"whoShouldSkip":["Brain injury not caused by trauma, haemorrhage or stroke","Previous brain injury","Other relevant neurological conditions which could affect outcome measures (e.g., Parkinson's or Alzheimer's disease)","No stable and suitable place to sleep"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Oxford. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.221Z"},{"nctId":"NCT07215234","title":"A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","officialTitle":"A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).\n\nThe core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.\n\nThe treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).","conditions":["Geographic Atrophy"],"keywords":[],"interventions":[{"type":"DRUG","name":"SAR446597"},{"type":"DRUG","name":"Sham Comparator"}],"enrollment":104,"startDate":"2025-10-09","completionDate":"2027-10-13","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 60 years old or above\n* Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)\n* Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200\n* Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II\n\nExclusion Criteria:\n\n* GA in the study eye caused by a disease different than AMD\n* Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye\n* Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments\n* Current or history of systemic complement targeting treatment in the past 12 months\n* Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye\n* History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye\n* History of active ocular infection in the study eye in 6 months prior to screening\n* Presence of active ocular or periocular infections\n* Active uncontrolled glaucoma in the study eye\n* History of uveitis or scleritis in either eye\n* Previous gene therapy in either eye\n* Any significant poorly controlled illness that would preclude study compliance and follow up\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Associated Retina Consultants - Peoria- Site Number : 8400011","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Macula Institute of Arizona- Site Number : 8400028","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Retina Partners- Site Number : 8400040","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macula Retina Vitreous Center - Torrance- Site Number : 8400053","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitreo Retinal Associates - Gainesville- Site Number : 8400004","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Florida Eye Institute- Site Number : 8400038","city":"Stuart","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeast Retina Center- Site Number : 8400044","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Retina - Lemont- Site Number : 8400005","city":"Lemont","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Retina Group of Washington - Chevy Chase- Site Number : 8400009","city":"Chevy Chase","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003","city":"Hagerstown","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Specialist- Site Number : 8400055","city":"Towson","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sierra Eye Associates- Site Number : 8400021","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059","city":"Wake Forest","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Retina- Site Number : 8400017","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Atlantic Retina - Bethlehem- Site Number : 8400031","city":"Bethlehem","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erie Retina Research- Site Number : 8400035","city":"Erie","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute - Ladson- Site Number : 8400016","city":"Ladson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute - Ladson- Site Number : 8400046","city":"Ladson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates - Arlington- Site Number : 8400056","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Austin- Site Number : 8400015","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas - Bellaire- Site Number : 8400019","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Foundation of the Southwest- Site Number : 8400001","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates - Dallas- Site Number : 8400006","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants of Texas - San Antonio- Site Number : 8400012","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Center of Texas (RCT) - Southlake- Site Number : 8400048","city":"Southlake","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360003","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360002","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360001","city":"East Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260001","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)","Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["peoria-arizona","scottsdale-arizona","beverly-hills-california","encino-california","oxnard-california","sacramento-california","torrance-california","walnut-creek-california","gainesville-florida","st-petersburg-florida","stuart-florida","augusta-georgia","lemont-illinois","chevy-chase-maryland","hagerstown-maryland","towson-maryland","reno-nevada","wake-forest-north-carolina","eugene-oregon","bethlehem-pennsylvania","erie-pennsylvania","ladson-south-carolina","arlington-texas","austin-texas","bellaire-texas","dallas-texas","san-antonio-texas","southlake-texas","sydney-australia","adelaide-australia","east-melbourne-australia","london-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing SAR446597 for Geographic Atrophy","inPlainEnglish":"This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and how well it works of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant.","whoItsFor":["Ages 60 Years to any","60 years old or above","Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)","Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200","Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II"],"whoShouldSkip":["GA in the study eye caused by a disease different than AMD","Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye","Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or how well it works assessments","Current or history of systemic complement targeting treatment in the past 12 months","Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye","History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye","History of active ocular infection in the study eye in 6 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are SAR446597, or Sham Comparator. The registry lists allocation as randomized. This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and how well it works of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 104 people at 35 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.150Z"},{"nctId":"NCT07216027","title":"A Study to Learn About Study Medicine Called PF-08049820 in People With Eczema","officialTitle":"A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08049820 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.\n\nThe study is seeking participants who:\n\n1. Are 18 to 64 years of age;\n2. Were confirmed to have AD at least 6 months ago;\n3. Do not have a suitable prescribed medicine for AD;\n4. Are considered by their doctors to have moderate to severe AD.\n\nThe study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.","conditions":["Atopic Dermatitis","Eczema, Atopic"],"keywords":["Eczema","Atopic Dermatitis"],"interventions":[{"type":"DRUG","name":"PF-08049820"},{"type":"DRUG","name":"Placebo"}],"enrollment":165,"startDate":"2025-11-20","completionDate":"2028-02-02","sex":"ALL","minAge":"18 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet the following criteria:\n\n1. Are 18 to 64 years of age\n2. Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs\n3. Have moderate to severe AD as defined by the following at screening and baseline visits:\n\n   * Affected body surface area (BSA) greater than or equal to 10% and up to 60%;\n   * Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;\n   * Eczema Area and Severity Index (EASI) greater than or equal to 16;\n\n   AND\n\n   -Peak Pruritis Numeric Rating Scale (PP-NRS) greater than or equal to 4 at screening and a weekly average of greater than or equal to 4 at baseline visit\n4. Do not have a suitable prescribed medicine for AD.\n5. Body Mass Index (BMI) of 18 to 38 kg/m2 and a total body weight greater than 48 kg (106 lbs)\n\nExclusion Criteria:\n\nParticipants must not meet the following criteria:\n\n1. Have an infection that requires treatment\n2. Have other skin conditions other than AD\n3. Have severe uncontrolled asthma\n4. Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit","locations":[{"facility":"Mayo Clinic Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Specialty Building","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marvel Clinical Research","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolis Dermatology - DTLA","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northridge Clinical Trials","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Science Institute","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gsi Clinical Research","city":"Margate","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Research of South Florida","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Montefiore - Jacobi Dermatology Clinic","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore - Clinical Research Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore - Greene Medical Arts Pavillion","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore - The Dermatology Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Apex Clinical Research Center, LLC. - Lorain","city":"Lorain","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Apex Clinical Research Center, LLC.","city":"Mayfield Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paddington Testing Co, Inc","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Department of Dermatology","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASMC - IPSMC - skin and venereal diseases","city":"Sofia","state":"Sofia (stolitsa)","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Consultative Centre (DCC) - Foкus 5","city":"Sofia","state":"Sofia (stolitsa)","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Consultative Center \"Ascendent\"","city":"Sofia","state":"","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Research Institute","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto Research Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Recherche Saint-Louis inc.","city":"Québec","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Fujian Medical University","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Province Dermatology Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"DERMAMEDICA s.r.o.","city":"Náchod","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CCR Ostrava, s.r.o.","city":"Ostrava","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia Czech s.r.o.","city":"Pardubice","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia Czech s.r.o.","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Saint Louis","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Charles Nicolle","city":"Rouen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Larrey","city":"Toulouse","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster","city":"Münster","state":"North Rhine-Westphalia","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein","city":"Lübeck","state":"Schleswig-Holstein","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Schleswig-Holstein","city":"Kiel","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hattori Dermatology Clinic","city":"Takasaki","state":"Gunma","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kosugi Dermatology Clinic","city":"Kawasaki-shi","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen's square Medical Facilities Queen's square Dermatology and Allergology","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology and Ophthalmology Kume Clinic","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nihonbashi Sakura Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laser Clinic S.C. dr Tomasz Kochanowski dr Andrzej Królicki","city":"Szczecin","state":"West Pomeranian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penta Hospitals Badania Kliniczne- Gdańsk 1","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Angelius Provita","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermedic Jacek Zdybski","city":"Kielce","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centrum Nowoczesnych Terapii Dobry Lekarz spółka z ograniczoną odpowiedzialnością","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia - Szczecinskie Centrum Medyczne","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Percent change from baseline in Eczema Area and Severity Index (EASI) total score at Week 12"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","scottsdale-arizona","huntington-beach-california","los-angeles-california","northridge-california","santa-monica-california","margate-florida","miami-florida","the-bronx-new-york","lorain-ohio","mayfield-heights-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","sofia-bulgaria","calgary-canada","toronto-canada","qu-bec-canada","fuzhou-china","guangzhou-china","shanghai-china","beijing-china","n-chod-czechia","ostrava-czechia","pardubice-czechia","prague-czechia","paris-france","rouen-france","toulouse-france","m-nster-germany","l-beck-germany","kiel-germany","takasaki-japan","kawasaki-shi-japan","yokohama-japan","sakai-japan","chuo-ku-japan","krakow-poland","szczecin-poland","gdansk-poland","katowice-poland","kielce-poland"],"enrichment":{"headline":"Phase 2: testing PF-08049820 for Atopic Dermatitis","inPlainEnglish":"This study wants to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin.","whoItsFor":["Ages 18 Years to 64 Years","Participants must meet the following criteria:","Are 18 to 64 years of age","Have clinical diagnosis of AD for at least 6 months prior to Day 1 and have diagnosis of AD confirmed by photographs","Have moderate to severe AD as defined by the following at screening and baseline visits:","Affected body surface area (BSA) greater than or equal to 10% and up to 60%;","Validated Investigator's Global Assessment (vIGA) greater than or equal to 3;","Eczema Area and Severity Index (EASI) greater than or equal to 16;"],"whoShouldSkip":["Participants must not meet the following criteria:","Have an infection that requires treatment","Have other skin conditions other than AD","Have severe uncontrolled asthma","Regular use (more than 2 visits per week) of a tanning booth or phototherapy for AD within 4 weeks of the screening visit"],"whatHappens":"If you join, the listed intervention(s) are PF-08049820, or Placebo. The registry lists allocation as randomized. This study wants to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 165 people at 51 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.821Z"},{"nctId":"NCT07216248","title":"Optimal PSA Triggered Individual Management of Androgen Sensitive Prostate Cancer","officialTitle":"A Phase II Randomized, Decentralized, De-escalation Study in Patients With Metastatic Hormone-Sensitive Prostate Cancer Achieving Optimal PSA Response (OPTIMAS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Utah","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.","conditions":["Metastatic Hormone-sensitive Prostate Cancer (mHSPC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"relugolix + ARPI"},{"type":"DRUG","name":"Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI"},{"type":"DRUG","name":"relugolix or androgen deprivation therapy (ADT) + ARPI"},{"type":"DRUG","name":"relugolix + ARPI."}],"enrollment":160,"startDate":"2025-10-28","completionDate":"2030-10","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCohort A Eligibility (Step 1 Registration)\n\n* Participant aged ≥ 18 years\n* Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.\n* Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site.\n* Baseline testosterone \\>50 ng/dl before start of therapy for metastatic disease\n* PSA ≥ 1 ng/mL before start of therapy for metastatic disease\n* ECOG Performance Status ≤ 2\n* Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.\n* Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.\n\n  * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.\n  * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.\n* Clinically significant adverse effects from any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy) must have resolved or have been determined to be clinically stable per the Investigator.\n* Has access to a smartphone and wireless services and is able to download and navigate study specific applications.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nCohort A Eligibility (Step 2 Registration):\n\n* PSA ≤ 0.2 ng/mL after 6-12 months of relugolix and androgen receptor pathway inhibitor treatment. Androgen receptor pathway inhibitor includes abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.\n\nCohort B Eligibility\n\n* Participant aged ≥ 18 years\n* Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology.\n* Metastasis detected any time prior to study registration on conventional or functional imaging as determined by clinical investigator and can be of any site.\n* PSA ≤ 0.2 ng/mL after treatment with androgen deprivation therapy or androgen receptor pathway inhibitor treatment or both of any duration. Androgen deprivation therapy in this context includes gonadotropin-releasing hormone agonists and antagonists. Androgen receptor pathway inhibitors include abiraterone, enzalutamide, apalutamide, darolutamide or similar drugs.\n* Eligible to receive standard of care treatment with relugolix and APRI per clinical investigator.\n* Participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception requirements as described in Section 5.5.1.\n\n  * If the risk of seminal transfer from the participant is present, the participant must agree to use a condom during sexual intercourse as described in Section 5.5.2.\n  * Participants must agree not to donate sperm from the start of study therapy until 3 months after the last dose of study therapy.\n* Has access to a smartphone and wireless services and is able to download and navigate study specific applications.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\nCohort A Eligibility (Step 1 Registration)\n\n* Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Known brain metastases or cranial epidural disease.\n\n  --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry.\n* Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).\n* Participants taking prohibited medications as described in Section 6.6.2.\n\nCohort A Eligibility (Step 2 Registration)\n\n* Receiving other systemic anti-cancer therapy for prostate cancer. Prior treatment before Step 2 registration is allowed.\n* Progression to metastatic castration-resistant prostate cancer per clinical investigator.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Participants taking prohibited medications as described in Section 6.6.2.\n\nCohort B Eligibility\n\n* Receiving other systemic anti-cancer therapy for prostate cancer.\n* History of surgical castration.\n* The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study.\n* Known brain metastases or cranial epidural disease.\n\n  --Note: Brain metastases or cranial epidural disease adequately treated with radiotherapy and/or surgery and stable for at least 4 weeks before the first dose of study treatment will be allowed on trial. Participants must be neurologically stable and receiving a stable or decreasing corticosteroid dose at the time of study entry\n* Current evidence of uncontrolled, significant intercurrent illness, infection, compliance or other safety concerns which may affect clinical trial participation.\n* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).\n* Participants taking prohibited medications as described in Section 6.6.1.","locations":[{"facility":"Huntsman Cancer Institute at University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erynn Peyton","phone":"801-213-5601","email":"Erynn.Peyton@hci.utah.edu"},{"name":"Umang Swami, MD, MSCI, FASCO","phone":"801-585-0255","email":"Umang.Swami@hci.utah.edu"}],"primaryOutcomes":["Cohort A: Brief Fatigue Inventory (BFI) score 6 months after randomization.","Cohort B: Progression-free survival (PFS) as defined as the time from intermittent study initiation (first treatment break) to the time of documented disease progression or death from any cause at one year."],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["salt-lake-city-utah"],"enrichment":{"headline":"Phase 2: testing relugolix + ARPI for Metastatic Hormone-sensitive Prostate Cancer (mHSPC)","inPlainEnglish":"This study wants to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.","whoItsFor":["Ages 18 Years to any","Men only","Cohort A Eligibility (Step 1 Registration)","Participant aged ≥ 18 years","Hormone-sensitive prostate cancer with histologically/cytologically confirmed adenocarcinoma without small cell histology","Metastasis detected any time prior to study registration on conventional or functional imaging as determined by the treating investigator and can be of any site","Baseline testosterone \\>50 ng/dl before start of therapy for metastatic disease","PSA ≥ 1 ng/mL before start of therapy for metastatic disease","how well you can do daily activities (ECOG score) ≤ 2"],"whoShouldSkip":["Cohort A Eligibility (Step 1 Registration)","Participant received androgen deprivation therapy (defined as leuprolide or surgical castration) for metastatic hormone-sensitive prostate cancer","The diagnosis of another malignancy which, in the opinion of the Investigator, is likely to negatively impact the participant's safety or ability to participate in the study","Known brain metastases or cranial epidural disease","Current evidence of uncontrolled, significant intercurrent illness, infection, non-compliance or other safety concerns which may affect clinical trial participation","Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3)","Participants taking prohibited medications as described in Section 6.6.2"],"whatHappens":"If you join, the listed intervention(s) are relugolix + ARPI, Intermittent- Relugolix or androgen deprivation therapy (ADT) + ARPI, or relugolix or androgen deprivation therapy (ADT) + ARPI. The registry lists allocation as randomized. This study wants to evaluate intermittent relugolix + androgen receptor pathway inhibitor (ARPI) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) achieving optimal PSA response.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at Salt Lake City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.312Z"},{"nctId":"NCT07216703","title":"A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)","officialTitle":"A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb). Metastatic means the cancer has spread to other parts of the body.\n\nResearchers want to learn about giving the study medicine sacituzumab tirumotecan (also called sac-TMT or MK-2870) along with pembrolizumab and bevacizumab treatments. Sac-TMT is an antibody drug conjugate, which is a type of medicine that attaches to specific targets on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this study are to learn:\n\n* About the safety of sac-TMT with pembrolizumab and bevacizumab, and if people tolerate them when given together, and\n* If people who receive sac-TMT and pembrolizumab, with or without bevacizumab, live longer overall or without their cancer getting worse as compared to those who receive standard treatment","conditions":["Cervical Cancer"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","Trophoblast Cell Surface Antigen 2 (TROP2)"],"interventions":[{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"BIOLOGICAL","name":"Sacituzumab Tirumotecan"},{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Rescue Medications"}],"enrollment":1023,"startDate":"2026-01-19","completionDate":"2031-10-29","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix\n* Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \\[FIGO\\]-2018 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)\n* If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy\n* If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has tumor programmed cell death ligand 1 expression of combined positive score ≥1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has received prior systemic anticancer therapy other than what is specified in this protocol\n* Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT\n* Has a diagnosis of immunodeficiency\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and/or carcinomatous meningitis\n* Has active autoimmune disease that has required systemic treatment in the past 2 years; replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments\n* Has a history of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","locations":[{"facility":"University of Alabama- Birmingham ( Site 5015)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Womens Cancer Care ( Site 5046)","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHAO Family Comprehensive Cancer Center and Ambulatory Care ( Site 5037)","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moores Cancer Center-Clinical Trials Office - Gynecological Oncology ( Site 5000)","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine Medical Center ( Site 6006)","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - South ( Site 7001)","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Braman Comprehensive Cancer Center ( Site 5043)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai Comprehensive Cancer Center ( Site 6000)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffit Cancer Center ( Site 5026)","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - East ( Site 7000)","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute of Emory University ( Site 5005)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nancy N. & J.C. Lewis Cancer and Research Pavillion - Research Department ( Site 6005)","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TRIALS 365 ( Site 6008)","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Oncology Hematology (MOH) ( Site 8001)","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minnesota Oncology Hematology, PA ( Site 8003)","city":"Edina","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Methodist Hospital ( Site 5010)","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's Cancer Center of Nevada ( Site 6011)","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5039)","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 6009)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 5020)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 6002)","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Cancer Specialists and Research Institute, LLC ( Site 6001)","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8007)","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Honickman Center ( Site 5033)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asplundh Cancer Pavilion ( Site 5002)","city":"Willow Grove","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women & Infants Hospital ( Site 6003)","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Medical Center ( Site 6012)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8005)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital-Obstetrics and Gynecology ( Site 6010)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology-The Woodlands ( Site 8000)","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas ( Site 8002)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center ( Site 5044)","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Cancer Center ( Site 6014)","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute ( Site 5045)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oncología e Investigación de Buenos Aires ( Site 0107)","city":"Berazategui","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clinicas Mar del Plata ( Site 0105)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar ( Site 0101)","city":"Belgrano","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Misionero del Cancer ( Site 0112)","city":"Posadas","state":"Misiones Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia de Rosario ( Site 0104)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Provincial del Centenario ( Site 0106)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Privado CEMAIC ( Site 0102)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0111)","city":"La Rioja","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Wien ( Site 0302)","city":"Vienna","state":"State of Vienna","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitat Graz ( Site 0303)","city":"Graz","state":"Styria","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitaet Innsbruck ( Site 0301)","city":"Innsbruck","state":"Tyrol","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniklinikum Salzburg Landeskrankenhaus ( Site 0304)","city":"Salzburg","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antwerp University Hospital ( Site 0407)","city":"Edegem","state":"Antwerpen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc ( Site 0402)","city":"Brussels","state":"Bruxelles-Capitale, Region de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Hopital de Charleroi ( Site 0404)","city":"Charleroi","state":"Hainaut","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Liège - 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(OS)"],"hasResults":false,"conditionSlugs":["cervical-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["birmingham-alabama","anchorage-alaska","irvine-california","la-jolla-california","orange-california","fort-myers-florida","miami-beach-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","savannah-georgia","shreveport-louisiana","columbia-maryland","edina-minnesota","omaha-nebraska","las-vegas-nevada","mineola-new-york","new-york-new-york","cincinnati-ohio","columbus-ohio","tulsa-oklahoma","eugene-oregon","philadelphia-pennsylvania","willow-grove-pennsylvania","providence-rhode-island","knoxville-tennessee","fort-worth-texas","houston-texas","the-woodlands-texas","tyler-texas","charlottesville-virginia","fairfax-virginia","berazategui-argentina","mar-del-plata-argentina","belgrano-argentina","posadas-argentina","rosario-argentina","c-rdoba-argentina","la-rioja-argentina","vienna-austria","graz-austria","innsbruck-austria","salzburg-austria","edegem-belgium","brussels-belgium","charleroi-belgium","li-ge-belgium","ghent-belgium","leuven-belgium","goi-nia-brazil","natal-brazil","porto-alegre-brazil","barretos-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","rio-de-janeiro-brazil","calgary-canada","edmonton-canada","halifax-canada","london-canada","toronto-canada","montreal-canada","qu-bec-canada","sherbrooke-canada","temuco-chile","la-serena-chile","santiago-chile","vi-a-del-mar-chile","rionegro-colombia","barranquilla-colombia","bogot-colombia","monter-a-colombia","pereira-colombia","brno-czechia","nov-ji-n-czechia","ostrava-czechia","prague-czechia","odense-c-denmark","strasbourg-france","pierre-b-nite-france","brest-france","caen-france","chambray-l-s-tours-france","bordeaux-france","toulouse-france","paris-france","jena-germany","berlin-germany","hamburg-germany","athens-greece","cha-d-ri-greece","budapest-hungary","debrecen-hungary","visakhapatnam-india","belagavi-india","cork-ireland","dublin-ireland","hadera-israel","haifa-israel","jerusalem-israel","petah-tikva-israel","tel-aviv-israel","meldola-italy","aviano-italy","milan-italy","brescia-italy","catania-italy","padova-italy","roma-italy","torino-italy","treviso-italy","nagoya-japan","t-on-japan","kurume-japan","ta-japan","sapporo-japan","akashi-japan","shiwa-gun-japan","yokohama-japan","ginowan-japan","hidaka-japan","sunto-gun-japan","ch-japan","koto-japan","minato-japan","shinjyuku-japan","fukuoka-japan","niigata-japan","okayama-japan","osaka-japan","guadalajara-mexico","benito-ju-rez-mexico","mexico-city-mexico","monterrey-mexico","chihuahua-city-mexico","oaxaca-city-mexico","cebu-city-philippines","makati-city-philippines","manila-philippines","warsaw-poland","gliwice-poland","siedlce-poland","kielce-poland","johannesburg-south-africa","pretoria-south-africa","soweto-south-africa","hilton-south-africa","cape-town-south-africa","goyang-si-south-korea","jongno-gu-south-korea","seodaemun-gu-south-korea","seoul-south-korea","girona-spain","valencia-spain","barcelona-spain","c-rdoba-spain","madrid-spain","lund-sweden","stockholm-sweden","link-ping-sweden","taiwan-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkok-thailand","chiang-mai-thailand","edinburgh-united-kingdom","truro-united-kingdom","london-united-kingdom","withington-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Pembrolizumab for Cervical Cancer","inPlainEnglish":"Researchers are looking for new ways to treat metastatic cervical cancer. Cervical cancer is cancer in the cervix, the lower part of the uterus (womb).","whoItsFor":["Ages 18 Years to any","Women only","The main include but are not limited to the following:","Has a histologically confirmed diagnosis of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of cervix","Has persistent, recurrent, or newly diagnosed metastatic (International Federation of Gynecology and Obstetrics \\[FIGO\\]-2018 Stage IVB) cervical cancer that is not amenable to curative treatment (surgery and/or radiation)","If infected with human immunodeficiency virus (HIV), has well controlled HIV on antiretroviral therapy","If positive for hepatitis B surface antigen, has received hepatitis B virus (HBV) antiviral therapy and has undetectable HBV viral load","If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load","Has an Eastern Cooperative Oncology Group performance status of 0 or 1"],"whoShouldSkip":["include but are not limited to the following:","Has HIV infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease","Has received prior systemic anticancer therapy other than what is specified in this protocol","Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 that cannot be discontinued for the duration of treatment with sac-TMT"],"whatHappens":"If you join, the listed intervention(s) are Pembrolizumab, Sacituzumab Tirumotecan, or Bevacizumab. The registry lists allocation as randomized. Researchers are looking for new ways to treat metastatic cervical cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,023 people at 191 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.339Z"},{"nctId":"NCT07217067","title":"A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation","officialTitle":"A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation","conditions":["Atrial Fibrillation"],"keywords":["Atrial fibrillation","Atrial fibrillation burden","Arrhythmia"],"interventions":[{"type":"DRUG","name":"PKN605"},{"type":"OTHER","name":"Placebo"}],"enrollment":165,"startDate":"2025-10-28","completionDate":"2027-09-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n-Inclusions at Screening\n\n* Signed informed consent must be obtained prior to participation in the study\n* Male and female participants ≥ 18 years of age\n* History of atrial fibrillation\n* AF (atrial fibrillation or atrial flutter) within the last 12 months (or during screening) documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator\n* Meets one or more of the following criteria:\n\nA. Recurrent AF (≥ 2 episodes), and ≥ 1 of the following\n\n* AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months\n* CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)\n* Stable heart failure or with New York Heart Association class I or II symptoms\n* NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months B. AFB ≥ 1% or an AF episode lasting ≥ 2 h during Screening, including when detected using a study provided ECG patch monitor C. Persistent AF, as confirmed by the Investigator\n\n  * On guideline-directed stroke prevention treatment, as confirmed by the Investigator\n  * Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared\n* Inclusions at Day 1\n\n  * Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)\n\nExclusion Criteria:\n\n-Exclusions at Screening\n\n* Permanent AF\n* Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)\n* Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)\n* History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.\n* Implanted pacemaker, defibrillator, or cardiac monitor\n* Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy\n* Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used\n* Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening","locations":[{"facility":"Cardiology Associates of North MS","city":"Tupelo","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cooper University Hospital","city":"Camden","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Univ Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Medical Center","city":"Murray","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Heart and Vascular Clinic","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Halifax","state":"Nova Scotia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Newmarket","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bad Homburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Arnhem","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Maastricht","state":"Limburg","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Delft","state":"South Holland","country":"Netherlands","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Goes","state":"Zeeland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Groningen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Veldhoven","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Singapore","state":"Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Brighton","state":"East Sussex","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Newcastle upon Tyne","state":"Tyne and Wear","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Liverpool","state":"","country":"United Kingdom","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Atrial fibrillation burden from ECG patch monitors"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["tupelo-mississippi","camden-new-jersey","new-york-new-york","durham-north-carolina","murray-utah","seattle-washington","calgary-canada","vancouver-canada","halifax-canada","hamilton-canada","london-canada","newmarket-canada","toronto-canada","montreal-canada","qu-bec-canada","sherbrooke-canada","beijing-china","xian-china","bad-homburg-germany","berlin-germany","hamburg-germany","arnhem-netherlands","maastricht-netherlands","delft-netherlands","goes-netherlands","groningen-netherlands","veldhoven-netherlands","singapore-singapore","brighton-united-kingdom","newcastle-upon-tyne-united-kingdom","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing PKN605 for Atrial Fibrillation","inPlainEnglish":"A randomly assigned, compared with a dummy treatment, participant-and investigator-blinded study to measure the how well it works in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation","whoItsFor":["Ages 18 Years to any","Inclusions at Screening","Male and female participants ≥ 18 years of age","History of atrial fibrillation","AF (atrial fibrillation or atrial flutter) within the last 12 months (or during screening) documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator","Meets one or more of the following criteria:","A. Recurrent AF (≥ 2 episodes), and ≥ 1 of the following","AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months"],"whoShouldSkip":["Exclusions at Screening","Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)","Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)","History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation","Implanted pacemaker, defibrillator, or cardiac monitor","Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy","Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used"],"whatHappens":"If you join, the listed intervention(s) are PKN605, or Placebo. The registry lists allocation as randomized. A randomly assigned, compared with a dummy treatment, participant-and investigator-blinded study to measure the how well it works in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 165 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.747Z"},{"nctId":"NCT07218211","title":"Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP","officialTitle":"INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.","conditions":["HIV Prevention","HIV Pre-exposure Prophylaxis","HIV Prevention Program","HIV Prevention and Care","HIV Pre-exposure Prophylaxis Use"],"keywords":["Long-acting Injectable PrEP","Lenacapavir","PrEP","PrEP injections"],"interventions":[{"type":"DRUG","name":"Lenacapavir long-acting"}],"enrollment":100,"startDate":"2026-01-13","completionDate":"2027-07-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be assigned male sex at birth.\n* Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative.\n* Identify as Hispanic and/or Latine .\n* Be able to provide informed consent in English or Spanish .\n* Be 18 years or older .\n* Weigh at least 77 lbs (35 kg) by self-reported weight.\n* Interested in PrEP and willing to undergo the study procedures.\n\nExclusion Criteria:\n\n* Individuals living with HIV.\n* Individuals assigned female sex at birth will be excluded.\n* Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded.\n* Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded.\n* Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.","locations":[{"facility":"El Centro Hispano","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Iris Navarro Clinical Research Coordinator","phone":"919-660-3940","email":"inclusion@duke.edu"}],"primaryOutcomes":["Acceptability of the intervention measured by questionnaire","Feasibility of the intervention measured by programmatic indicators","Sustainability of the intervention","The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months."],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Phase 4: testing Lenacapavir long-acting for HIV Prevention","inPlainEnglish":"The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.","whoItsFor":["Ages 18 Years to any","Men only","Participants must be assigned male sex at birth","Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative","Identify as Hispanic and/or Latine","Be 18 years or older","Weigh at least 77 lbs (35 kg) by self-reported weight","Interested in PrEP and willing to undergo the study procedures"],"whoShouldSkip":["Individuals living with HIV","Individuals assigned female sex at birth will be excluded","Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded","Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded","Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study"],"whatHappens":"If you join, the listed intervention(s) are Lenacapavir long-acting. The registry lists allocation as na. The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at Durham. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.396Z"},{"nctId":"NCT07218276","title":"Passive Robots for Stroke Rehabilitation: A Feasibility Study","officialTitle":"Passive Robots for Stroke Rehabilitation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.","conditions":["Stroke"],"keywords":["synergy","upper extremity","stroke survivors","robot","hemiparesis","weakness"],"interventions":[{"type":"DEVICE","name":"Functional Training with SepaRRo and NeuRRoFES"}],"enrollment":4,"startDate":"2025-11-05","completionDate":"2027-10-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 75 years;\n* Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;\n* No major deficits of sensation or proprioception;\n\nExclusion Criteria:\n\n* Bilateral stroke\n* Unable to think clearly and remember (Mini-Mental State Exam score \\< 22 and miniMOCA \\< 8);\n* Uncontrolled Diabetes or Hypertension;\n* Severe limitations of joint range of motion that will lead to inability of testing\n* Severe spasticity and joint contractures that will lead to inability of testing\n* Complete paresis with no possible movements\n* Severe aphasia\n* Any other medical condition that will significantly impact the study results\n* Unable to obtain reliable motor evoked potentials\n* Are pregnant or are actively trying to conceive\n* Have a recent history of repeated fainting spells or syncope.\n* Have a recent history of seizure (epilepsy) while on anti-seizure medication\n* Have a recent history of skull fracture/head injury\n* Have metal implants in the skull\n* Have cardiac pacemakers","locations":[{"facility":"University of Michigan - NeuRRo Lab","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chandramouli Krishnan, PT, PhD","phone":"7349364031","email":"mouli@umich.edu"},{"name":"Thomas E Augenstein, PhD","phone":"7342320898","email":"tomaugen@umich.edu"}],"primaryOutcomes":["Device Survey For Feasibility"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Functional Training with SepaRRo and NeuRRoFES for Stroke","inPlainEnglish":"This study wants to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.","whoItsFor":["Ages 18 Years to 75 Years","Age 18 to 75 years;","Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;","No major deficits of sensation or proprioception;"],"whoShouldSkip":["Unable to think clearly and remember (Mini-Mental State Exam score \\< 22 and miniMOCA \\< 8);","Uncontrolled Diabetes or Hypertension;","Severe limitations of joint range of motion that will lead to inability of testing","Severe spasticity and joint contractures that will lead to inability of testing","Complete paresis with no possible movements","Any other medical condition that will significantly impact the study results","Unable to obtain reliable motor evoked potentials"],"whatHappens":"If you join, the listed intervention(s) are Functional Training with SepaRRo and NeuRRoFES. The registry lists allocation as na. This study wants to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 4 people at Ann Arbor. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.210Z"},{"nctId":"NCT07218315","title":"Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma","officialTitle":"Nanosecond Pulsed Field Ablation in the Management of T1N0M0 Papillary Thyroid Carcinoma","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This study is to evaluate the effectiveness of nsPFA in treating papillary thyroid microcarcinoma. T","conditions":["Thyroid Carcinoma"],"keywords":[],"interventions":[{"type":"DEVICE","name":"CellFX nsPFA Percutaneous Electrode System"}],"enrollment":15,"startDate":"2026-02-11","completionDate":"2029-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must provide voluntary, written informed consent to participate in this clinical investigation.\n* Participant agrees to comply with all study procedures, including all follow-up visits.\n* Participant with a Bethesda VI cytology (tumor size \\<= 1.5 cm, no known regional/distant metastases)\n* Participant with a Bethesda V cytology and normal calcitonin levels.\n* Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases.\n* Participant must have normal complete blood count, blood coagulation profile, and thyroid function test.\n* For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure.\n* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: ). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n  * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n  * History of hysterectomy or bilateral salpingo-oophorectomy.\n  * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n  * History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study procedure.\n\nExclusion Criteria:\n\n* FNA findings suggestive of high-grade malignancy\n* Presence of regional or distant lymph node metastases.\n* Participant had a history of previous neck irradiation.\n* Females who are pregnant at time of enrollment.\n* Participant has any condition or situation, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's participation in the study.","locations":[{"facility":"Sarasota Memorial Hospital","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas M. D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Victoria E Banuchi, MPH","phone":"713-563-7600","email":"vebanuchi@mdanderson.org"}],"primaryOutcomes":["Safety and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["sarasota-florida","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: CellFX nsPFA Percutaneous Electrode System for Thyroid Carcinoma","inPlainEnglish":"This study is to measure the effectiveness of nsPFA in treating papillary thyroid microcarcinoma.","whoItsFor":["Ages 18 Years to any","Participant agrees to comply with all study procedures, including all follow-up visits","Participant with a Bethesda VI cytology (tumor size \\<= 1.5 cm, no known regional/distant metastases)","Participant with a Bethesda V cytology and normal calcitonin levels","Ultrasonographic evaluation of tumor to be ablated must show size of less than or equal to 1.5 cm and no extrathyroidal extension or locoregional metastases","Participant must have normal complete blood count, blood coagulation profile, and thyroid function test","For females of childbearing potential, a negative serum or urine pregnancy test must be obtained at baseline, prior to the procedure","Postmenopausal (no menses in greater than or equal to 12 consecutive months)"],"whoShouldSkip":["FNA findings suggestive of high-grade malignancy","Presence of regional or distant lymph node metastases","Participant had a history of previous neck irradiation","Females who are pregnant at time of enrollment","Participant has any condition or situation, in the opinion of the site Investigator, that puts the subject at significant risk, could confound the study results, or may interfere significantly with subject's participation in the study"],"whatHappens":"If you join, the listed intervention(s) are CellFX nsPFA Percutaneous Electrode System. The registry lists allocation as na. This study is to measure the effectiveness of nsPFA in treating papillary thyroid microcarcinoma.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 15 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.336Z"},{"nctId":"NCT07218445","title":"The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity","officialTitle":"The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.","conditions":["Obesity","Menopause Hot Flashes"],"keywords":["Hot flashes","menopause","Tirzepatide","GLP"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":40,"startDate":"2026-04-08","completionDate":"2027-09-18","sex":"FEMALE","minAge":"46 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria\n\n1. Females\n2. Age 46-60 years old.\n3. BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).\n4. Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).\n5. Hot flashes must be present for \\>30 days prior to study entry.\n6. Willingness to self-inject drug\n7. Provided informed consent to be part of the study.\n8. Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal/day relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal/day. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.\n\nExclusion Criteria\n\n1. Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.\n2. Any current, recent use (past 4 weeks), or planned use of:\n\n   1. Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).\n   2. Vaginal estrogen.\n   3. Androgens.\n   4. Progestogens.\n3. Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.\n4. Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.\n5. Menopause as a result of cancer treatments.\n6. Impaired renal function (GFR ≤30 ml/min/1.73 m²).\n7. Thyroid-stimulating hormone ≥7 with low free T4.\n8. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.\n9. \\>5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).\n10. Other obesity medication was used within the past 3 months.\n11. History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \\> 1 year before screening).\n12. Past or intended endoscopic and/or device-based therapy or removal within last six months.\n13. Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time\n14. Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.\n\n16\\. Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.\n\n15\\. Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.\n\n16\\. Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days.\n\n17\\. Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.","locations":[{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica Hoag","phone":"904-953-5290","email":"hoag.jessica@mayo.edu"},{"name":"Lauren Uy","phone":"904-953-5337","email":"uy.lauren@mayo.edu"}],"primaryOutcomes":["Change in Vasomotor Symptoms Frequency","Change in Vasomotor Symptom Severity","Aging Biomarkers: Cellular Senescence Markers in Plasma","Difference between biological and chronological age"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["jacksonville-florida"],"enrichment":{"headline":"Phase 4: testing Tirzepatide for Obesity","inPlainEnglish":"This study wants to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.","whoItsFor":["Ages 46 Years to 60 Years","Women only","Age 46-60 years old","body-mass index (BMI) ≥30 kg/m2 or body-mass index (BMI) ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease)","Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment)","Hot flashes must be present for \\>30 days prior to study entry","Willingness to self-inject drug"],"whoShouldSkip":["Current or recent use (past 4 weeks) treatment with menopausal hormone therapy","Any current, recent use (past 4 weeks), or planned use of:","Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets)","Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis","Current or recent use (past 4 weeks) of fezolinetant or elinzanetant","Menopause as a result of cancer treatments","Impaired renal function (GFR ≤30 ml/min/1.73 m²)"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Placebo. The registry lists allocation as randomized. This study wants to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 40 people at Jacksonville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.035Z"},{"nctId":"NCT07219173","title":"A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma","officialTitle":"A Phase 2, Multicenter, Randomized, Double-blind, 52-week Study, to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Uncontrolled Moderate to Severe Asthma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the safety and efficacy of brenipatide at different dose levels compared with placebo in participants with moderate-to-severe asthma.\n\nStudy participation will last approximately 65 weeks, including screening, treatment, and follow-up periods.","conditions":["Asthma"],"keywords":["Incretin"],"interventions":[{"type":"DRUG","name":"Brenipatide"},{"type":"DRUG","name":"Brenipatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":531,"startDate":"2025-10-22","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit.\n* Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization.\n* History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit.\n\nExclusion Criteria:\n\n* Participants are excluded from the study if any of the following criteria apply:\n\n  * An established diagnosis of occupational asthma\n* Known pre-existing, clinically important lung condition other than asthma, including but not limited to:\n\n  * chronic respiratory infection\n  * bronchiectasis\n  * pulmonary fibrosis\n  * allergic bronchopulmonary aspergillosis\n  * emphysema\n  * chronic bronchitis\n  * eosinophilic granulomatosis with polyangiitis\n  * chronic obstructive pulmonary disease, and\n  * other mimics of asthma, that is, vocal cord dysfunction.\n* Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.","locations":[{"facility":"AMR Clinical","city":"Tempe","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewportNativeMD, Inc.","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Medical Research Associates","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula Research Associates","city":"Rolling Hills Estates","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asthma & Allergy Associates - Colorado Springs","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avanza Medical Research Center","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USF Health","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axis Clinical Trials - Westchester","city":"Westchester","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy & Asthma Specialists, P.S.C.","city":"Owensboro","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Equity Medical","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy and Clinical Immunology Associates","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt Asthma, Sinus and Allergy Program","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Data Point Clinical - Paramount Clinical Research","city":"Kirkland","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consultorios Médicos, Organización del Buen Ayre S.R.L.","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Metabólicas (CINME)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"IDIM - Instituto de Investigaciones Metabólicas","city":"Ciudad de Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Asma, Alergia y Enfermedades Respiratorias","city":"Corrientes","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Clínicas Baigorria","city":"Granadero Baigorria","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clínicas Mar del Plata","city":"Mar del Plata","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Río Cuarto","city":"Río Cuarto","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"ABC Instituto de Diagnóstico","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ibamedica","city":"Santa Fe","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewData Clinical Research - 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.346Z"},{"nctId":"NCT07219394","title":"Peer-Delivered Behavioral Activation in a CCBHC","officialTitle":"Hybrid Effectiveness-Implementation Trial to Evaluate a Scalable, Peer-Delivered Intervention for Depression Among People With Substance Use Disorder in a Certified Community Behavioral Health Clinic","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Wayne State University","sponsorClass":"OTHER","summary":"Low-income individuals have limited access to evidence-based interventions for mental health. Peer recovery specialists, individuals in recovery from mental health and/or substance use problems, have the potential to increase access to evidence-based interventions for individuals from low-resource communities, particularly when trained and supervised in models that are acceptable and feasible in these communities. 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The trial consists of 2 Parts: a non-randomized Safety-run-in part (Part 1) and the subsequent randomized part (Part 2) with 2 treatment arms (A and B). Randomization of participants into Treatment Arm A and B will continue until 40 efficacy-evaluable participants are enrolled into each Treatment Arm.","conditions":["Unresectable or Metastatic Hepatocellular Carcinoma","Child-Pugh A Hepatocellular Carcinoma","Failure of First-Line Treatment That Included an Approved Anti PD-(L)1 Compound"],"keywords":["CTL-002","Visugromab","GDF-15"],"interventions":[{"type":"BIOLOGICAL","name":"Visugromab RDE (recommended dose for expansion)"},{"type":"BIOLOGICAL","name":"Nivolumab"},{"type":"DRUG","name":"Lenvatinib"},{"type":"OTHER","name":"Placebo Saline Infusion"}],"enrollment":104,"startDate":"2026-03-19","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Main Inclusion Criteria:\n\n* Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach.\n* Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment.\n* Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period.\n* Age ≥ 18 years on the day of signing the informed consent.\n* Life expectancy of at least 3 months as assessed by the Investigator.\n* ECOG performance status ≤1.\n* Child-Pugh score of A6 or better.\n\nMain Exclusion Criteria:\n\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma.\n* More than 1 line of prior systemic treatment for unresectable or metastatic HCC.\n* Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP.\n* Expected to require any other form of antineoplastic therapy during the trial.\n* Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction.\n* Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy.\n* Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors.\n* Have one of the following cardiovascular risk factors: myocardial infarction, peri/myocarditis, or history of ischemic stroke in the past 3 months before planned treatment start, uncontrolled heart failure, uncontrolled ventricular arrhythmia, QT interval corrected for heart rate using Fridericia's formula interval ≥ 470 ms regardless of sex.\n* An active autoimmune disease that has required systemic treatment in past 3 months before planned treatment start.\n* Comedication with metformin or metformin-containing antidiabetics in participants with type II diabetes.\n* Chronic systemic corticosteroid treatment for other reasons.\n* Prior liver or other organ transplantation.","locations":[{"facility":"UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health. Chao Family Comprehensive Cancer Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Hematology/Oncology - Santa Monica","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peidmont Healthcare, Inc","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF St. Francis Medical Center","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montpellier University Hospital Center - Saint Eloi Hospital","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Bordeaux - Hôpital Haut-Lévêque","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poitiers University Hospital Center - Miletrie Hospital","city":"Poitiers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hannover Medical School","city":"Hanover","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Cologne, Clinic of Gastroenterology and Hepatology","city":"Cologne","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center of Johannes Gutenberg University Mainz","city":"Mainz","state":"Rhineland-Palatinate","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Frankfurt Johann Wolfgang Goethe- Universität","city":"Frankfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Polyclinic S. Orsola-Malpighi","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffale, IRCCS","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asst Grande Ospedale Metropolitano Niguarda","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale S.Maria delle Croci","city":"Ravenna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Miguel Servet","city":"Zaragoza","state":"Aragon","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalan Institute of Oncology, Hospital Duran i Reynals","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic of Barcelona","city":"Barcelona","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinic of Navarra - Pamplona","city":"Pamplona","state":"Chartered Community of Navarra","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Ramon y Cajal","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chia-Yi Christian Hospital","city":"Chiayi City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western General Hospital","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tomáš Janík, MD","phone":"+49892000664","email":"regulatory-005@catalym.com"}],"primaryOutcomes":["Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["irvine-california","los-angeles-california","orange-california","santa-monica-california","atlanta-georgia","peoria-illinois","boston-massachusetts","montpellier-france","pessac-france","poitiers-france","villejuif-france","hanover-germany","cologne-germany","mainz-germany","frankfurt-germany","bologna-italy","milan-italy","ravenna-italy","zaragoza-spain","lhospitalet-de-llobregat-spain","barcelona-spain","pamplona-spain","madrid-spain","chiayi-city-taiwan","taipei-taiwan","edinburgh-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Visugromab RDE (recommended dose for expansion) for Unresectable or Metastatic Hepatocellular Carcinoma","inPlainEnglish":"This is a Phase 2b, randomly assigned, blinded clinical trial investigating the how well it works and safety of visugromab in combination with nivolumab and Lenvatinib compared to double dummy treatment (placebo) and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound. The trial consists of 2 Parts: a non-randomly assigned Safety-run-in part (Part 1) and the subsequent randomly assigned part (Part 2) with 2 treatment arms (A and B).","whoItsFor":["Ages 18 Years to 100 Years","Histologically confirmed diagnosis of unresectable or metastatic HCC, not amenable to a curative treatment approach","Measurable disease as per RECIST v1.1 as determined by the Investigator based upon local radiologist assessment","Must have failed one line of prior systemic treatment for unresectable or metastatic HCC containing an approved anti PD (L)-1 checkpoint inhibitor (CPI) with a minimum treatment duration of 12 weeks exposure for the CPI with no documented progression in this period","Life expectancy of at least 3 months as assessed by the Investigator","how well you can do daily activities (ECOG score) ≤1","Child-Pugh score of A6 or better"],"whoShouldSkip":["Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma","More than 1 line of prior systemic treatment for unresectable or metastatic HCC","Received or completed any palliative radiotherapy for symptoms within 28 days of the first dose of IMP","Expected to require any other form of antineoplastic therapy during the trial","Clinically active inflammatory bowel disease, active diverticulitis, intra-abdominal abscess, and/or gastrointestinal obstruction","Known history of other prior malignancy unless participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy","Known or detected clinically active central nervous system (CNS) involvement by HCC or other tumors"],"whatHappens":"If you join, the listed intervention(s) are Visugromab RDE (recommended dose for expansion), Nivolumab, or Lenvatinib. The registry lists allocation as randomized. This is a Phase 2b, randomly assigned, blinded clinical trial investigating the how well it works and safety of visugromab in combination with nivolumab and Lenvatinib compared to double dummy treatment (placebo) and Lenvatinib in participants with unresectable or metastatic HCC and compensated liver function (Child-Pugh A) after failure of 1L treatment that included an anti-PD-(L)1 compound.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 104 people at 29 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.619Z"},{"nctId":"NCT07220824","title":"A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting","officialTitle":"GUselkumab for the Treatment of PsA: Effectiveness Results by Ultrasound","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches) using muscoloskeletal ultrasound (MSUS) in a real-world setting.","conditions":["Arthritis, Psoriatic"],"keywords":[],"interventions":[],"enrollment":200,"startDate":"2025-12-04","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Diagnosis of PsA as per CASPAR classification criteria for at least six months with active PsA defined as a tender joint count (TJC) greater than or equal to (\\>=) 3/68 and a swollen joint count (SJC) \\>= 3/66 at baseline, or C-reactive protein (CRP) \\>=0.3 milligrams per deciliter (mg/dL) if TJC and/or SJC are less than (\\<) 3\n* a) Total synovitis power doppler ultrasound (PDUS) score \\>=2 and inflammation related to power doppler (PD) signal \\>=2 for at least 1 affected joint of 48 joints at the baseline visit (before first Guselkumab administration), or b) Total synovitis PDUS score \\>=2 and inflammation related to PD signal \\>=1 for at least 2 affected joints of 48 joints at the baseline visit (before first Guselkumab administration)\n* Start guselkumab for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study or within a maximum of two weeks after the initial baseline visit\n* Participants must be biologic-naïve or previously exposed to only one biologic Disease-Modifying Antirheumatic Drugs (bDMARD) and/or apremilast/deucravacitinib\n* At least one clinically involved enthesitis site, defined by SPARCC index \\>= 1, and one imaging-detected enthesitis site at baseline\n\nExclusion criteria:\n\n* Previous exposure to Guselkumab or to more than one bDMARD for any indications\n* Prior treatment with Janus kinase (JAK) inhibitors\n* Contraindications to Guselkumab as per the summary of product characteristics (SmPC)\n* Current enrollment in other investigational study or participation in other investigational study completed from less than 30 days\n* Current enrollment in an observational study with Guselkumab sponsored or managed by sponsor","locations":[{"facility":"Policlinico di Bari","city":"Bari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Spedali Civili Brescia","city":"Brescia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Carlo Urbani","city":"Iesi","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale Galeazzi Sant Ambrogio","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Ortopedico Gaetano Pini","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Raffaele Hospital","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST Grande Ospedale Metropolitano Niguarda","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seconda Univesità degli Studi di Napoli, AOU","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone","city":"Palermo","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Fondazione IRCCS Policlinico San Matteo","city":"Pavia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universita degli Studi di Perugia","city":"Perugia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Santa Chiara AO Universitaria Pisana","city":"Pisa","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Carlo Di Potenza - Azienda Ospedaliera Regionale","city":"Potenza","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcispedale Santa Maria Nuova - IRCCS","city":"Reggio Emilia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Di Tor Vergata","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario A Gemelli IRCCS","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"A O Universitaria Senese Ospedale Santa Maria alle Scotte","city":"Siena","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AO Ordine Mauriziano","city":"Torino","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ASST dei Sette Laghi, Ospedale di Circolo e Fonazione Macchi","city":"Varese","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Integrata Verona","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage Reduction From Baseline in Global OMERACT and EULAR Synovitis Score (GLOESS) at Week 12","Percentage of Participants Achieving Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity (LDA) Score Less Than or Equal to 14, at Week 24"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["bari-italy","brescia-italy","iesi-italy","milan-italy","naples-italy","palermo-italy","pavia-italy","perugia-italy","pisa-italy","potenza-italy","reggio-emilia-italy","roma-italy","siena-italy","torino-italy","varese-italy","verona-italy"],"enrichment":{"headline":"A Study of Guselkumab in Participants With Psoriatic Arthritis (PsA) in a Real-World Setting","inPlainEnglish":"This study wants to assess how well guselkumab works in improving symptoms of psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches) using muscoloskeletal ultrasound (MSUS) in a real-world setting.","whoItsFor":["Ages 18 Years to any","Start guselkumab for the indication of PsA as part of standard clinical practice at the time of enrollment into the watch-and-measure (no experimental treatment required) study or within a maximum of two weeks after the initial baseline visit","Participants must be biologic-naïve or previously exposed to only one biologic Disease-Modifying Antirheumatic Drugs (bDMARD) and/or apremilast/deucravacitinib","At least one clinically involved enthesitis site, defined by SPARCC index \\>= 1, and one imaging-detected enthesitis site at baseline"],"whoShouldSkip":["Previous exposure to Guselkumab or to more than one bDMARD for any indications","Prior treatment with Janus kinase (JAK) inhibitors","Contraindications to Guselkumab as per the summary of product characteristics (SmPC)","Current enrollment in other investigational study or participation in other investigational study completed from less than 30 days","Current enrollment in an watch-and-measure (no experimental treatment required) study with Guselkumab sponsored or managed by sponsor"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 21 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.578Z"},{"nctId":"NCT07221032","title":"FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma","officialTitle":"Phase I Study of FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Medical College of Wisconsin","sponsorClass":"OTHER","summary":"This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.","conditions":["Relapse Multiple Myeloma","Refractory Multiple Myeloma"],"keywords":["multiple myeloma","CAR-T therapy"],"interventions":[{"type":"BIOLOGICAL","name":"FT836 CAR T cells (1 x 10^8 cells per dose)"},{"type":"BIOLOGICAL","name":"FT836 CAR T cells (3 x 108 cells per dose)"},{"type":"BIOLOGICAL","name":"FT836 CAR T cells (up to 9 x 108 cells per dose)"},{"type":"DRUG","name":"Daratumumab 16 mg/kg"}],"enrollment":12,"startDate":"2026-08-05","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients must ≥18 years and \\< 80 years old.\n2. Patients must have received \\>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:\n\n   • International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy.\n3. Patients must have measurable disease, including at least one or more of the following criteria:\n\n   1. Serum M-protein ≥ 0.5 g/dl;\n   2. Urine M-protein ≥ 200 mg/24 hrs;\n   3. Involved serum light chain ≥100 mg/L with abnormal light chain ratio;\n4. Karnofsky performance score ≥70.\n5. Adequate hepatic function, defined as:\n\n   1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \\<3x upper limit of normal (ULN);\n   2. Serum bilirubin \\<2.0 mg/dL except for patients with Gilbert's syndrome, who must have serum bilirubin of \\<3 mg/dL.\n6. Absolute neutrophil count (ANC) ≥1,000 with no G-CSF within 72 hours or pegylated G-CSF within 10 days.\n7. Platelets ≥50,000 with no transfusion within 72 hours of eligibility testing.\n8. Adequate renal function, defined as creatinine clearance ≥50 mL/min calculated using the Cockroft-Gault formula.\n9. Able to provide written informed consent.\n10. Agree to practice birth control during the study.\n11. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% -- by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA) -- and adequate pulmonary function as indicated by room air oxygen saturation of ≥90%.\n12. Expected survival \\>12 weeks.\n13. Negative urine or serum pregnancy test in females of childbearing potential at study entry.\n14. No contraindication to central line access. Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of the eligibility criteria. Lactating women are eligible for this study but will be asked not to provide breast milk to their child from Day -11 through Day +90 after CAR T-cell therapy. It is possible they may no longer be able to lactate after receiving chemotherapy and treatment.\n\nDue to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double-barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide.\n* Intrauterine device (IUD).\n* Hormonal-based contraception. Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, tubal ligation, salpingectomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception.\n\nExclusion Criteria:\n\n1. Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab.\n6. Refusal to participate in the long-term follow-up protocol.\n7. Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture.\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing last treatment was ≥2 weeks before start of daratumumab and a remission documented within four weeks of planned CAR T-cell infusion by MRI brain and Cerebrospinal Fluid (CSF) analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\<6 months post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, and AL amyloidosis.\n10. Prior treatment with gene therapy or any gene-modified cellular therapy.\n11. Cytotoxic chemotherapy, oral chemotherapeutic agents, or antibody-directed treatment within 14 days of starting daratumumab or after starting daratumumab.\n\n    1. Corticosteroids are allowable up until seven days prior to starting daratumumab and after starting daratumumab for disease control up until the day prior to cell infusion (Day -1).\n    2. Radiation is allowed to a single symptomatic site.\n12. Patients post solid organ transplant who develop high-grade lymphomas or leukemias.\n13. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n14. Active bacterial, viral, or fungal infection requiring systemic treatment.\n15. Patients who have received major surgery one week prior to starting daratumumab and three weeks prior to lymphodepletion.\n16. Active malignancy that required therapy in the last two years except successfully treated non-metastatic basal or squamous cell carcinoma, or prostate carcinoma that does not require therapy. Other similar conditions may be discussed with and permitted by the medical monitor.","locations":[{"facility":"Froedtert & the Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical College of Wisconsin Cancer Center Clinical Trials Office","phone":"866-680-0505","email":"cccto@mcw.edu"}],"primaryOutcomes":["Incidence of Grade 3 or higher adverse events"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":["car-t"],"locationSlugs":["milwaukee-wisconsin"],"enrichment":{"headline":"Phase 1: testing FT836 CAR T cells (1 x 10^8 cells per dose) for Relapse Multiple Myeloma","inPlainEnglish":"This is a phase I, treatment, single-arm, open-label, dose-finding treatment study designed to measure the safety and preliminary how well it works of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.","whoItsFor":["Ages 18 Years to 80 Years","Patients must ≥18 years and \\< 80 years old","Patients must have received \\>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:","International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy","Patients must have measurable disease, including at least one or more of the following criteria:","Serum M-protein ≥ 0.5 g/dl;","Urine M-protein ≥ 200 mg/24 hrs;","Involved serum light chain ≥100 mg/L with abnormal light chain ratio;"],"whoShouldSkip":["Positive beta-Human Chorionic Gonadotropin (HCG) in female of child-bearing potential","Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection","History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily","Presence of ≥ Grade 3 non-hematologic toxicities as per Common Terminology Criteria for side effects (CTCAE) version 5.0 from any previous treatment unless it is felt to be due to underlying disease","Concurrent use of investigational therapeutic agents or enrollment in another therapeutic clinical trial at any institution. A minimum of 14 days or five half-lives of the drug (whichever is shorter) washout prior to start of daratumumab","Refusal to participate in the long-term follow-up protocol","Patients with active Central Nervous System (CNS) involvement by malignancy on magnetic resonance imaging (MRI) or by lumbar puncture"],"whatHappens":"If you join, the listed intervention(s) are FT836 CAR T cells (1 x 10^8 cells per dose), FT836 CAR T cells (3 x 108 cells per dose), or FT836 CAR T cells (up to 9 x 108 cells per dose). The registry lists allocation as randomized. This is a phase I, treatment, single-arm, open-label, dose-finding treatment study designed to measure the safety and preliminary how well it works of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at Milwaukee. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.501Z"},{"nctId":"NCT07221149","title":"A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (ROSETTA Gastric-204)","officialTitle":"ROSETTA Gastric-204: A Blinded, Randomized, Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy in Participants With Previously Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and efficacy of Pumitamig in combination with chemotherapy versus Nivolumab in combination with chemotherapy in participants with previously untreated advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma","conditions":["Untreated Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma"],"keywords":["Gastric Cancer","Gastroesophageal Junction Cancer","Esophageal Adenocarcinoma"],"interventions":[{"type":"DRUG","name":"Pumitamig"},{"type":"DRUG","name":"Folfox"},{"type":"DRUG","name":"Capox"},{"type":"DRUG","name":"Nivolumab"}],"enrollment":690,"startDate":"2026-03-13","completionDate":"2030-11-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must be previously untreated with systemic treatment for advanced/metastatic disease, histologically or cytologically confirmed advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC) or distal esophageal adenocarcinoma (EAC). GEJ involvement can be confirmed via biopsy, endoscopy, or imaging.\n* Participants must have a documented programmed cell death-(ligand)1 (PD-L1) ≥ 1 or \\< 1 status for Phase 2, and document PD-L1 ≥ 1 status for the Phase 3 part of the study.\n* Participants must have documented human epidermal growth factor receptor 2 (HER2)-negative cancer, as determined according to local guidelines.\n* Participants must have measurable disease as defined by RECIST v1.1.\n\nExclusion Criteria\n\n* Participants must not have untreated known central nervous system (CNS) metastases.\n* Participants must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis, cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.\n* Participants must not have evidence of major coagulation disorders (eg, hemophilia).\n* Participants must not have a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism within 3 months prior to randomization, unless the participant has been fully treated (eg, inferior vena cava filter placed) and/or adequately anticoagulated on a stable dose.\n* Participants must not have a history of abdominal fistula or gastrointestinal (GI) perforation within 6 months of randomization.\n* Participants must not have had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study intervention.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Mayo Clinic in Arizona - 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.975Z"},{"nctId":"NCT07221188","title":"A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.","conditions":["Non-alcoholic Fatty Liver Disease"],"keywords":["Metabolic Dysfunction-Associated Steatohepatitis","efimosfermin alfa","Safety","Tolerability","Phase 3","ZENITH-2"],"interventions":[{"type":"DRUG","name":"Efimosfermin Alfa"},{"type":"DRUG","name":"Placebo"}],"enrollment":1250,"startDate":"2025-12-12","completionDate":"2028-03-24","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures\n* Age \\>=18 through \\<=75 years at enrolment\n* History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition\n* History or presence of known or suspected MASH with evidence of fibrosis\n\nExclusion Criteria:\n\n* ALT or AST \\>=5 × upper limit of normal (ULN)\n* Total bilirubin (BILI) \\>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \\>=1.3 mg/dL and direct BILI is \\<=20% of total BILI; otherwise, the individual will be excluded.\n* Serum albumin \\<=3.5 grams per deciliter (g/dL)\n* International normalized ratio (INR) \\>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.\n* Alkaline phosphatase (ALP) \\>=2 × ULN\n* Platelet (PLT) count \\<140 000 per (/) cubic millimeter (mm\\^3); individuals with a PLT count between 110,000/mm\\^3 and 140,000/mm\\^3 may be enrolled after discussion with the Study Medical Monitor\n* Serum creatinine \\>=1.5 mg/dL or creatinine clearance \\<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.\n* Alpha-fetoprotein \\>=20 nanogram per milliliter (ng/mL)\n* HbA1c \\>=9.0%\n* Model for End-Stage Liver Disease (MELD) 3.0 score \\>=12 unless the score is elevated in the absence of liver dysfunction (eg, Gilbert's syndrome)\n* Phosphatidylethanol (PEth) \\>=80 nanogram per milliliter (ng/mL) at Screening\n* Known co-infection with any of the following: a. Human immunodeficiency virus; b. Hepatitis B virus; c. 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Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor","Alkaline phosphatase (ALP) \\>=2 × ULN","Platelet (PLT) count \\<140 000 per (/) cubic millimeter (mm\\^3); individuals with a PLT count between 110,000/mm\\^3 and 140,000/mm\\^3 may be enrolled after discussion with the Study Medical Monitor","Serum creatinine \\>=1.5 mg/dL or creatinine clearance \\<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation","Alpha-fetoprotein \\>=20 nanogram per milliliter (ng/mL)"],"whatHappens":"If you join, the listed intervention(s) are Efimosfermin Alfa, or Placebo. The registry lists allocation as randomized. This study will measure the whether it is safe and how hard side effects are to live with of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,250 people at 55 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.167Z"},{"nctId":"NCT07221344","title":"Trial of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease or Primary Tauopathies","officialTitle":"A Phase 1/2a Placebo-controlled Dose-escalating Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease or Primary Tauopathies","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Arrowhead Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"Trial to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia, as well as primary tauopathies, including microtubule associated protein tau -related frontotemporal dementia (MAPT-FTD) and progressive supranuclear palsy- Richardson syndrome (PSP-RS).","conditions":["Alzheimer Disease","Tauopathies","Frontotemporal Dementia","Progressive Supranuclear Palsy"],"keywords":["microtubule associated protein tau-related frontotemporal dementia","MAPT-FTD","progressive supranuclear palsy- Richardson syndrome","PSP-RS"],"interventions":[{"type":"DRUG","name":"ARO-MAPT-SC"},{"type":"DRUG","name":"Placebo"}],"enrollment":160,"startDate":"2025-11-18","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria (All Participants):\n\n* Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\\^2) at Screening\n* Not pregnant or breast-feeding\n* Able and willing to provide written informed consent prior to the performance of any trial specific procedures\n* Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the trial and for at least 90 days following the end of the trial or last dose of trial drug, whichever is later; participants must not donate sperm or eggs during the trial and for at least 90 days following the end of the trial or last dose of trial drug whichever is later\n\nInclusion Criteria (Early AD):\n\n* Adults aged 50 to ≤80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis\n* If participant is on non-disease-modifying AD medications, the doses must be stable for ≥8 weeks prior to Screening.\n\n  1. Participants with early AD are not required to be on AD medications.\n  2. Participants previously treated or currently receiving anti-amyloid therapies, including lecanemab and donanemab, are not eligible.\n\nInclusion Criteria (MAPT-FTD)\n\n* Adults ≥18 years of age with Clinical Dementia Rating plus National Alzheimer's Coordinating Center Frontotemporal Lobar Degeneration-Neuropsychiatric and Motor domains Sum of Boxes Global Score of 0.5 or 1 at Screening\n* Frontotemporal Lobar Degeneration (F-causative MAPT mutation, based on source verifiable medical records.\n* If the participant is on medications for symptomatic management of MAPT-FTD, the doses must be stable for ≥8 weeks prior to Screening.\n\nInclusion Criteria (PSP-RS)\n\n* Adults ≥41 to ≤86 years of age with clinical diagnosis of probable PSP-RS phenotype as defined by the 2017 Movement Disorder Society criteria (Höglinger 2017) with symptom onset ≥40 to ≤85 years of age\n* Presence of PSP symptoms ≤3 years at Screening (occurring newly and subsequently progressing during the clinical course in the absence of another identifiable cause) as determined by the Investigator\n* Mini-Mental Status Examination (MMSE) score of 20 to 30 (inclusive) at Screening\n* Able to walk at least 10 steps with minimal assistance (eg, one arm for safety, but not postural support)\n* Reside at home or in the community (assisted living is acceptable); outside of a skilled nursing facility or dementia care facility at the time of screening, with no planned admissions to such a facility at time of Screening.\n* If the participant is on medications for symptomatic management of PSP-RS, the doses must be stable for ≥8 weeks prior to Screening.\n\nInclusion Criteria (AD and primary tauopathies)\n\n* Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to trial visits involving informant-based assessments, to be available to site staff by telephone as needed, and in the opinion of the Investigator, be sufficiently familiar with the participant throughout the trial in order to provide accurate and reliable information relevant to trial outcome measures\n\nExclusion Criteria (All Participants):\n\n* Blood pressure outside of specified range in the protocol\n* Human immunodeficiency virus (HIV) infection (seropositive at Screening)\n* Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening\n* Intellectual disability or significant behavioral neuropsychiatric manifestation\n* Clinically significant cardiac, liver, or renal disease\n* Any contraindications to lumbar puncture\n* Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients\n\nNote: Additional inclusion/exclusion criteria may apply per protocol.","locations":[{"facility":"Research Site 3","city":"East York","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 2","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 4","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 1","city":"Grafton","state":"Auckland","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical Monitor","phone":"626-304-3400","email":"AROMAPT-SC-1001@arrowheadpharma.com"}],"primaryOutcomes":["Number of Participants with Treatment-emergent Adverse Events (TEAEs) Over Time"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["east-york-canada","toronto-canada","montreal-canada","grafton-new-zealand"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ARO-MAPT-SC for Alzheimer Disease","inPlainEnglish":"Trial to measure the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MAPT-SC compared to dummy treatment (placebo) in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia, as well as primary tauopathies, including microtubule associated protein tau -related frontotemporal dementia (MAPT-FTD) and progressive supranuclear palsy- Richardson syndrome (PSP-RS).","whoItsFor":["Ages 18 Years to any","(All Participants):","Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m\\^2) at Screening","Not pregnant or breast-feeding","who can join (Early AD):","Adults aged 50 to ≤80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis","If participant is on non-disease-modifying AD medications, the doses must be stable for ≥8 weeks prior to Screening","Participants with early AD are not required to be on AD medications"],"whoShouldSkip":["(All Participants):","Blood pressure outside of specified range in the protocol","Human immunodeficiency virus (HIV) infection (seropositive at Screening)","Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening","Intellectual disability or significant behavioral neuropsychiatric manifestation","Clinically significant cardiac, liver, or renal disease","Any contraindications to lumbar puncture"],"whatHappens":"If you join, the listed intervention(s) are ARO-MAPT-SC, or Placebo. The registry lists allocation as randomized. Trial to measure the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARO-MAPT-SC compared to dummy treatment (placebo) in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia, as well as primary tauopathies, including microtubule associated protein tau -related frontotemporal dementia (MAPT-FTD) and progressive supranuclear palsy- Richardson syndrome (PSP-RS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.318Z"},{"nctId":"NCT07221734","title":"Study to Compare Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced [Unresectable or Metastatic] Melanoma","officialTitle":"Randomised, Multicentre, Multinational, Double-Blind Integrated Study to Compare the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of MB11 (Proposed Nivolumab Biosimilar) Versus EU-/US-Opdivo® in Subjects With Previously Untreated Advanced (Unresectable or Metastatic) Melanoma (LEON Study)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"mAbxience Research S.L.","sponsorClass":"INDUSTRY","summary":"This is a randomised, multicentre, multinational, double-blind, integrated study to sompare the pharmacokinetics, efficacy, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma","conditions":["Advanced (Unresectable or Metastatic) Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"MB11 (Proposed Nivolumab Biosimilar)"},{"type":"DRUG","name":"EU-Opdivo®"},{"type":"DRUG","name":"US- sourced Opdivo®"}],"enrollment":632,"startDate":"2025-12-29","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years at the time of signing the informed consent (or adulthood where the legalage of majority in the country is established \\>18 years).\n2. Body weight ≥50 kg at baseline.\n3. Signed informed consent must be obtained before initiation of any study-specific procedures or treatment.\n4. ECOG performance status of 0 or 1.\n5. Life expectancy for at least 3 months.\n6. Untreated, histologically confirmed advanced unresectable Stage III or Stage IV melanoma, as per AJCC 8th Edition staging system. Prior melanoma systemic therapy for earlier stages is allowed for patients who have been disease-free for at least 1 year after end of therapy, except if therapy included use of prohibited medications. Prior use of immune therapies (adjuvant or neoadjuvant) is not allowed as per Exclusion Criteria #2.\n7. At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria.\n8. Tumour tissue from an unresectable or metastatic site of disease, collected within 90 days prior to randomisation, must be available and provided for PD-L1 testing. All samples must be classified as PD-L1 positive (≥1% to \\<5% or ≥5%). If only the old sample \\>90 days is available and there is no possibility of having a new biopsy sample, then the subject will be excluded.\n9. In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug administration. No adjuvant radiation therapies are allowed.\n10. Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown).\n11. Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:\n\n    1. Haematologic function: absolute neutrophil count ≥1.5 × 109/L, platelets 9≥100 × 10 /L, and haemoglobin ≥9 g/dL.\n\n       \\*\\* Subjects should not have received RBC transfusion prior to 14 days beforescreening labs.\n    2. Renal function: serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL/min (using the Cockcroft-Gault formula).\n    3. Liver function: total bilirubin level ≤1.5 × ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \\<3.0 mg/dL), albumin level ≥LLN, AST/ALT ≤2.5 × ULN (≤5 × ULN for subjects with liver metastases).\n    4. Endocrine function: TSH within normal limits. If TSH is not within normal limits, the subject may still be eligible if T3 and free T4 are within normal limits.\n    5. Coagulation: INR and aPTT ≤1.5 × ULN unless the subject is receiving anticoagulant therapy. Subjects on anticoagulant therapy must be on a stable anticoagulation regimen and have an INR not above the target therapeutic range for the 14 days preceding the start of the study drug.\n12. Female subjects of childbearing potential and their partners, as well as male subjects with female partners of childbearing potential and their partners, must agree to adhere to the use of a highly effective method of contraception during the study and for at least 5 months after the last dose of nivolumab. Refer to Appendix 15.1 for contraception guidance.\n13. Non-fertile females can be included.\n\nExclusion Criteria:\n\n1. Subjects receiving any prior systemic therapy for advanced, unresectable, or metastatic Stage III or Stage IV melanoma (except for palliative radiotherapy, in accordance with Inclusion Criteria #9).\n2. Subjects receiving any prior immunotherapy (regardless of the melanoma stage), such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-LAG or anti-CTLA-4 therapy (including ipilimumab or any other antibody or drug that specifically targets costimulation of T-cells or immune checkpoints) and/or BRAF-targeted therapy.\n3. Participation in another clinical study or treatment with another investigational agent within 4 weeks or 5 elimination half-lives prior to randomisation (whichever is longer)\n4. Brain metastases or leptomeningeal metastases. A negative brain imaging of less than 90 days prior to screening is required.\n5. Peritoneal melanomatosis.\n6. Ocular melanoma, mucosal melanoma and acral lentiginous melanoma.\n7. History of another malignancy or a concurrent malignancy. Exceptions include subjects who have been disease-free for 3 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible, for example cervical cancer in situ.\n8. Active autoimmune disease that has required systemic treatment in the last 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin or physiological corticosteroid replacement therapy for pituitary or adrenal insufficiency \\[daily prednisone at a dose of ≤10 mg or equivalent\\]) is not considered a form of systemic treatment.\n9. Subjects with hyperthyroidism or hypothyroidism are excluded but those subjects who are stable on hormone replacement will be allowed.\n10. Any diagnosis of immunodeficiency, systemic steroid therapy (replacement therapy outlined in Exclusion Criteria #8, inhaled, intranasal, intraocular, or topical steroids are allowed) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study drug.\n11. Any major surgery (eg, hip or spine surgery) less than 28 days prior to the first dose of the study drug.\n12. Having received a solid organ/tissue allogeneic or haematopoietic transplant.\n13. History and/or current interstitial lung disease or pneumonitis (non-infectious) requiring oral or IV steroids or another immunosuppressive drug.\n14. Any active or previous infection requiring therapy (oral or systemic) within 30 days prior to the first dose of the study drug.\n15. Have received or are about to receive a live virus vaccination within 30 days prior to the first dose of the study drug. Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.\n16. Known active TB or untreated latent TB.\n17. Positive serology for human immunodeficiency virus (HIV 1/2), hepatitis B (HBsAg positive and/or HBcAb positive, and HBV DNA positive, refer to Section 8.3.2.1) or hepatitis C (HCVAb positive and HCV RNA positive). In addition, subjects with untreated positive serology for Strongyloides spp will be excluded.\n18. At the time of signing the informed consent, the subject is a regular user (including \"recreational use\") of any illicit drug or have a recent history (within the past year) of substance abuse (including alcohol).\n19. Be pregnant or lactating or expecting to conceive during the study or up to 5 months after the last dose of the study drug.\n20. Immediate family member who is at the research site or sponsoring staff who is directlyninvolved in this study.\n21. Inability to comply with protocol procedures and/or any other acute or chronic medical condition that may increase the risk for the subject associated with study participation or study drug administration, that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.","locations":[{"facility":"Site 102002","city":"Banja Luka","state":"","country":"Bosnia and Herzegovina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 102001","city":"Sarajevo","state":"","country":"Bosnia and Herzegovina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 102003","city":"Zenica","state":"","country":"Bosnia and Herzegovina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 103009","city":"Barretos","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 103007","city":"Belo 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PhD","phone":"+34917711500","email":"Susana.Millan@mabxience.com"},{"name":"Camino Huerga","phone":"+34917711500","email":"Camino.Huerga@mabxience.com"}],"primaryOutcomes":["To demonstrate the Pharmacokinetic (PK) bioequivalence between MB11 and EU/ US-Opdivo.","To demonstrate the efficacy equivalence of MB11 and Opdivo® administered as first-line treatment in adult subjects with untreated, unresectable, or metastatic Stage III or Stage IV melanoma"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["nivolumab"],"locationSlugs":["banja-luka-bosnia-and-herzegovina","sarajevo-bosnia-and-herzegovina","zenica-bosnia-and-herzegovina","barretos-brazil","belo-horizonte-brazil","bento-gon-alves-brazil","blumenau-brazil","caxias-do-sul-brazil","iju-brazil","ja-brazil","lajeado-brazil","natal-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","rio-de-janeiro-brazil","santa-cruz-do-sul-brazil","s-o-caetano-do-sul-brazil","s-o-paulo-brazil","sorocaba-brazil","independencia-chile","la-florida-chile","providencia-chile","vi-a-del-mar-chile","batumi-georgia","tbilisi-georgia","efkarpia-greece","catanzaro-italy","siena-italy","arequipa-peru","lima-peru","trujillo-peru","funchal-portugal","lisbon-portugal","craiova-romania","bansk-bystrica-slovakia","barcelona-spain","bilbao-spain","huelva-spain","lleida-spain","madrid-spain","m-laga-spain","sabadell-spain","seville-spain","torrej-n-de-ardoz-spain","adapazar-turkey-t-rkiye","ankara-turkey-t-rkiye","ankaya-turkey-t-rkiye","diyarbak-r-turkey-t-rkiye","eski-ehir-turkey-t-rkiye","istanbul-turkey-t-rkiye","y-re-ir-turkey-t-rkiye","chernivtsi-ukraine","ivano-frankivsk-ukraine","kyiv-ukraine","lutsk-ukraine","ternopil-ukraine","uzhhorod-ukraine","vinnytsia-ukraine"],"enrichment":{"headline":"Phase 3: testing MB11 (Proposed Nivolumab Biosimilar) for Advanced (Unresectable or Metastatic) Melanoma","inPlainEnglish":"This is a randomly assigned, multicentre, multinational, neither you nor the study doctors know who gets the real treatment, integrated study to sompare the pharmacokinetics, how well it works, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma","whoItsFor":["Ages 18 Years to any","Body weight ≥50 kg at baseline","how well you can do daily activities (ECOG score) of 0 or 1","Life expectancy for at least 3 months"],"whoShouldSkip":["At least 1 measurable disease lesion by CT or MRI per RECIST v1.1 criteria","In the case of prior palliative radiotherapy (on metastatic lesions), this must have been completed at least 2 weeks prior to the study drug administration. No adjuvant radiation therapies are allowed","Any BRAF mutation status is allowed (BRAF-mutated, BRAF wild-type or non-mutated, or BRAF status unknown)","Adequate organ function (bone marrow, hepatic, renal, haematologic, endocrine, and coagulation function) should be demonstrated during the screening period. This is defined as:","Haematologic function: absolute neutrophil count ≥1.5 × 109/L, platelets 9≥100 × 10 /L, and haemoglobin ≥9 g/dL","\\*\\* Subjects should not have received RBC transfusion prior to 14 days beforescreening labs","Renal function: serum creatinine level ≤1.5 × ULN or calculated CrCl ≥60 mL/min (using the Cockcroft-Gault formula)"],"whatHappens":"If you join, the listed intervention(s) are MB11 (Proposed Nivolumab Biosimilar), EU-Opdivo®, or US- sourced Opdivo®. The registry lists allocation as randomized. This is a randomly assigned, multicentre, multinational, neither you nor the study doctors know who gets the real treatment, integrated study to sompare the pharmacokinetics, how well it works, safety, and immunogenicity of MB11 versus Opdivo® in subjects with previously untreated advanced (unresectable or Metastatic) Melanoma","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 632 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.017Z"},{"nctId":"NCT07221851","title":"Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders","officialTitle":"A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily Somatropin in Prepubertal Children and Adolescents With Growth Failure or Short Stature Due to Growth Hormone Sufficient Disorders - Turner Syndrome, SHOX Deficiency, Small for Gestational Age, and Idiopathic Short Stature","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ascendis Pharma A/S","sponsorClass":"INDUSTRY","summary":"This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin. Approximately 186 participants will be distributed equally (1:1), to receive either lonapegsomatropin for 2 years or somatropin for 1 year followed by lonapegsomatropin for 1 year. This trial will be conducted in the United States, France, Germany, Italy, Romania, Spain and South Korea.","conditions":["Turner Syndrome","Short Stature Homeobox Gene Mutation","Idiopathic Short Stature","Small for Gestational Age at Delivery"],"keywords":["Turner Syndrome","Noonan Syndrome","Growth Hormone","Short Stature","Growth Failure","Sex Chromosome Disorders","Chromosome Disorders","Endocrine System Diseases","Pituitary Hormones, Anterior","Pituitary Hormones","Hormones","Hormone Substitutes","Human Growth Hormone","Lonapegsomatropin","Sex Chromosome Disorders of Sex Development","Impaired Growth","somatropin","Growth Hormone Sufficiency","Short Stature Homeobox Gene Mutation","Short Stature Children Born Small for Gestational Age","Idiopathic Short Stature"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Lonapegsomatropin [SKYTROFA®]"},{"type":"COMBINATION_PRODUCT","name":"Somatropin Pen Injector"}],"enrollment":186,"startDate":"2025-12-12","completionDate":"2028-02","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Chronological age between ≥2 and \\<18 years, at start of screening.\n2. Naïve to growth hormone and growth hormone promoting therapies.\n3. Prepubertal.\n4. Able to stand without assistance.\n5. Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:\n\n   TS or SHOX-D (Léri-Weill dyschondrosteosis):\n   1. Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted.\n   2. Impaired growth or short stature defined as:\n\n   (i.) AHV \\<25th percentile over a time span of 6-16 months prior to screening utilizing a historical height properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\<5th percentile for sex and age according to the Centers for Disease Control Growth Charts for the United States\n\n   SGA without catch-up growth:\n\n   c. Birth weight and/or birth length \\< -2.0 SDS for gestational age according to the 2006 World Health Organization Child Growth Standards. For infants born premature, the Fenton Preterm Infant Growth Chart (Fenton 2013) should be used.\n\n   d. Impaired growth or short stature defined as: (i.) AHV \\<25th percentile over a time span of 6-16 months prior to screening properly documented in a health care setting (self-measurement record is not accepted) OR (ii.) Height \\< -2.0 SDS for age and sex according to the 2000 Centers for Disease Control Growth Charts for the United States for children ≥ 3 years or height \\< -2.5 SDS for age and sex according to the for children ≥ 2 years and \\< 3 years\n\n   ISS:\n\n   e. Height \\< -2.25 SDS for sex and age according to the Centers for Disease Control Growth Charts for the United States with no identifiable cause for short stature.\n\n   f. Documented normal GH-IGF-1 axis, defined as either: (i.)IGF-1 SDS \\>0 at screening based on central laboratory OR (ii.)Historical documentation of normal peak GH upon stimulation test (as defined by local institution) g. 46,XX chromosome as determined by karyotype or microarray if female. For karyotypes, a minimum of 30 cells must be counted.\n6. If on hormone replacement therapies for any hormone deficiencies other than growth hormone (e.g., adrenal, thyroid), must be on adequate and stable doses for ≥4 weeks prior to and throughout screening.\n7. Written, signed informed consent provided by parent(s) or legal guardian(s) of the participant. Assent should be signed by participant as required by IRB/HREC/IEC.\n\nExclusion Criteria:\n\n1. Advanced bone age X-ray by central reading defined as \\>20% above chronological age in months (Greulich 1959).\n2. Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males.\n3. Current clinical diagnosis of diabetic retinopathy\n4. Any diagnosis or presence at screening of the following:\n\n   1. Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study.\n   2. Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment.\n5. Signs/symptoms of intracranial hypertension, active proliferative retinopathy.\n6. Uncontrolled hypo- or hyperthyroidism.\n7. Uncontrolled diabetes mellitus (defined as: HbA1c \\>7.5% from central laboratory at screening).\n8. Known history or diagnosis of any gastrointestinal inflammatory condition, HIV, radiation exposure, other skeletal dysplasias, growth hormone deficiency, and/or cardio-thoracic surgery due to their independent effects on growth.\n9. Any significant hepatic or renal abnormality, such as abnormal renal function (defined as eGFR \\<60 mL/min/1.73m2).\n10. Undiagnosed or uncontrolled hypertension.\n11. Receiving treatment with any agent that might influence growth or interfere with GH secretion or action including any sex steroids and stimulants for attention-deficit/hyperactivity disorder (ADHD).\n12. High dose inhaled glucocorticoid for more than 28 consecutive days total over the course of 12 months.\n13. Female who is pregnant, plans to be pregnant, or breastfeeding.\n14. Participation in another interventional clinical trial involving an investigational compound within 90 days prior to screening or in parallel to this trial.\n15. Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures.\n16. Exclusion Criteria only applicable to TS:\n\n    1. Presence of Y chromosome material on genetic testing without history of gonadectomy.\n    2. Less than 10% of 45,X mosaicism.\n    3. Any known, clinically significant, congenital or acquired cardiovascular dysfunction that might interfere with growth.\n17. Exclusion Criteria only applicable to SGA:\n\n    a. Any known clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements: (i.)Chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors.\n\n    (ii.)Congenital abnormalities (causing skeletal abnormalities), including but not limited to skeletal dysplasias.\n18. Exclusion Criteria only applicable to ISS:\n\n    1. Known history of any condition that causes disproportionate short stature (i.e. skeletal dysplasias), chromosomal aneuploidy, significant gene mutations, or medical syndromes with short stature, including but not limited to Turner syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, abnormal SHOX-1 gene analysis or absence of gH receptors.","locations":[{"facility":"Ascendis Pharma Investigational Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascendis Pharma Investigational Site","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascendis Pharma Investigational Site","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascendis Pharma Investigational Site","city":"Aurora","state":"Colorado","country":"United 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3: Lonapegsomatropin [SKYTROFA®] for Turner Syndrome","inPlainEnglish":"This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\<18 years with open growth plates. The purpose of the study is to see how well treatment with once-weekly lonapegsomatropin works compared to treatment with daily somatropin.","whoItsFor":["Ages 2 Years to 17 Years","Chronological age between ≥2 and \\<18 years, at start of screening","Naïve to growth hormone and growth hormone promoting therapies","Able to stand without assistance","Diagnosis of TS, SHOX-D, SGA, or ISS with impaired growth or short stature, according to the following disease-specific criteria:","TS or SHOX-D (Léri-Weill dyschondrosteosis):","Diagnosis confirmed by a genetic test. NOTE: Historical test results are acceptable for proof of diagnosis. For karyotypes, a minimum of 20 cells must be counted","Impaired growth or short stature defined as:"],"whoShouldSkip":["Advanced bone age X-ray by central reading defined as \\>20% above chronological age in months (Greulich 1959)","Closed epiphyses as defined as bone age of ≥14.0 years in females or ≥16.0 years in males","Current clinical diagnosis of diabetic retinopathy","Any diagnosis or presence at screening of the following:","Untreated moderate or severe sleep apnea as determined by formal (local) read of an inpatient or at-home sleep study","Prader Willi syndrome with severe obesity, history of severe upper airway obstruction, or severe respiratory impairment","Signs/symptoms of intracranial hypertension, active proliferative retinopathy"],"whatHappens":"If you join, the listed intervention(s) are Lonapegsomatropin [SKYTROFA®], or Somatropin Pen Injector. The registry lists allocation as randomized. This basket trial will enroll prepubertal children and adolescents with clinically diagnosed and genetically confirmed (if applicable) TS, SHOX-D, SGA, or ISS between ages of ≥2 and \\<18 years with open growth plates.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 186 people at 50 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.437Z"},{"nctId":"NCT07221877","title":"A Study to Evaluate the Effect of KarXT on Urological Safety","officialTitle":"A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.","conditions":["Schizophrenia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Xanomeline/trospium chloride"}],"enrollment":60,"startDate":"2026-01-20","completionDate":"2027-12-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).\n* Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.\n* Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.\n\nExclusion Criteria\n\n* Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.\n* Other protocol-defined Inclusion/Exclusion criteria apply","locations":[{"facility":"Pillar Clinical Research- Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group, Inc","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel CNS - Garden Grove","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ATP Clinical Research","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kinetic Clinical Research","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Synergy Clinical Research","city":"Boynton Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Clinical Research","city":"Lauderhill","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uptown Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research -Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research Las Vegas","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hassman Research Institute Marlton Site","city":"Marlton","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0001","city":"Austin","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Dallas","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Change from baseline in voiding dynamics (Qmax) over time","Change from baseline in post-void residual volume (PVR) over time"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","bellflower-california","chino-california","garden-grove-california","orange-california","torrance-california","west-covina-california","boynton-beach-florida","lauderhill-florida","chicago-illinois","las-vegas-nevada","marlton-new-jersey","philadelphia-pennsylvania","austin-texas","desoto-texas"],"enrichment":{"headline":"Phase 4: testing Xanomeline/trospium chloride for Schizophrenia","inPlainEnglish":"This study wants to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.","whoItsFor":["Ages 18 Years to 65 Years","Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2)","Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a body-mass index (BMI) ≥18 and ≤ 40 kg/m2","Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements"],"whoShouldSkip":["Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Xanomeline/trospium chloride. The registry lists allocation as na. This study wants to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 60 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.033Z"},{"nctId":"NCT07222436","title":"Circulating Tumor DNA in High Risk Localized Prostate Cancer","officialTitle":"Circulating Tumor DNA in High Risk Localized Prostate Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Pittsburgh","sponsorClass":"OTHER","summary":"This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.","conditions":["Prostate Cancer"],"keywords":["prostatectomy","ctDNA"],"interventions":[],"enrollment":24,"startDate":"2025-09-23","completionDate":"2027-09-30","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Must have histologically confirmed prostate cancer.\n2. Age ≥ 18 years.\n3. ECOG performance status of 0-1.\n4. Must have the ability to understand and the willingness to sign a written informed consent document.\n5. Willing to provide serial blood samples for the study.\n6. Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens.\n7. Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:\n\n   o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20\n\n   \\*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate.\n8. Exploratory Cohort: Men with a diagnosis of prostate adenocarcinoma and one of the following:\n\n   * Localized prostate adenocarcinoma on active surveillance\n   * Biochemically-recurrent prostate adenocarcinoma after definitive local therapy\n   * Hormone-sensitive, metastatic prostate adenocarcinoma\n   * Metastatic CRPC\n\nExclusion Criteria:\n\n1. History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer.\n2. Receiving androgen deprivation or other systemic therapy for prostate cancer.\n3. Medical condition or social situation that may preclude adherence to the protocol.\n\n   \\-","locations":[{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brieanna Marino, MS","phone":"4126478258","email":"rowlesbm@upmc.edu"}],"primaryOutcomes":["ctDNA detection"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Circulating Tumor DNA in High Risk Localized Prostate Cancer","inPlainEnglish":"This prospective, non-therapeutic translational biomarker study will collect blood in patients with high risk localized prostate cancer prior to prostatectomy.","whoItsFor":["Ages 18 Years to any","Men only","Must have histologically confirmed prostate cancer","how well you can do daily activities (ECOG score) of 0-1","Willing to provide serial blood samples for the study","Willing to provide tumor tissue (prostatectomy for primary cohort; prostatectomy or biopsy for exploratory cohort) for correlative studies which will compare ctDNA to tumor specimens","Primary Cohort: High-risk localized prostate adenocarcinoma defined as one or more of the following:","o Clinical stage ≥ cT3a, Grade Group 4 or 5 (Gleason sum 8-10), and PSA ≥ 20","\\*Non-bulky pelvic lymphadenopathy and indeterminate findings on staging imaging (CT, bone scan, PSMA PET CT) are allowed if the surgeon believes RP is appropriate"],"whoShouldSkip":["History of another primary cancer within the last 3 years, except for non-melanomatous skin cancer","Receiving androgen deprivation or other systemic therapy for prostate cancer","Medical condition or social situation that may preclude adherence to the protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 24 people at Pittsburgh. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.313Z"},{"nctId":"NCT07222488","title":"A Clinical Study of MK-3120 in People With Bladder Cancer (MK-3120-003)","officialTitle":"Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder. In standard treatment for HR NMIBC, doctors first remove the tumor with a procedure called transurethral resection of the bladder tumor (TURBT). Researchers want to learn if using MK-3120, the study medicine, can treat HR NMIBC after TURBT. The goal of this study is to learn about the safety of MK-3120 and if people tolerate it.","conditions":["Bladder Cancer","Urinary Bladder Neoplasms"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-3120"}],"enrollment":45,"startDate":"2025-12-09","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally.\n* Is an individual whose most recent transurethral resection of bladder tumor (TURBT) was performed within 12 weeks before allocation and showed high-risk NMIBC histology. For individuals with papillary tumors (Ta and T1), a complete TURBT must have been performed, as characterized by attainment of a visually complete resection of all papillary tumors (Ta and T1).\n* Is either: a) Bacillus Calmette-Guérin (BCG)-naïve, defined as either having never received BCG or having received BCG more than 2 years before CIS +/- papillary high-risk NMIBC recurrence. Recurrence must be at least 24 months from the last exposure to BCG with evidence of complete response during the 2-year period post-BCG OR; b) BCG-exposed and received adequate BCG therapy and had recurrence of CIS +/- papillary high-risk NMIBC \\>12 months but ≤24 months after the last BCG dose.\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy.\n* Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation.\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.\n\nExclusion Criteria:\n\n* Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC).\n* Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years.\n* Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture.\n* Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours).\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active central nervous system metastases and/or carcinomatous meningitis.\n* Has active infection requiring systemic therapy.\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, or has current pneumonitis/ILD.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","locations":[{"facility":"Michael G Oefelein Clinical Trials ( Site 0005)","city":"Bakersfield","state":"California","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey ( Site 0007)","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Urologic Research Center ( Site 0006)","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Austin, PLLC ( Site 0008)","city":"Austin","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Medizinische Universität Wien ( Site 0021)","city":"Vienna","state":"State of Vienna","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent ( Site 0031)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Quebec - Hopital de l'Enfant-Jesus ( Site 0011)","city":"Québec","state":"Quebec","country":"Canada","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy ( Site 0041)","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"European Interbalkan Medical Center ( Site 0051)","city":"Thessaloniki","state":"","country":"Greece","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 0062)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Ricerche Cliniche di Verona ( Site 0072)","city":"Verona","state":"Veneto","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 0081)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Akershus Universitetssykehus ( Site 0091)","city":"Lorenskog","state":"Akershus","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Victoria ( Site 0111)","city":"Málaga","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 0112)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara University Health Practice and Research Hospitals ( Site 0132)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koc Universitesi Hastanesi ( Site 0133)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Number of Participants Who Experience a Dose-limiting Toxicity (DLT)","Number of Participants Who Experience One or More Adverse Events (AEs)","Number of Participants Who Discontinue Study Treatment Due to AEs"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["bakersfield-california","new-brunswick-new-jersey","myrtle-beach-south-carolina","austin-texas","vienna-austria","ghent-belgium","qu-bec-canada","villejuif-france","thessaloniki-greece","petah-tikva-israel","verona-italy","amsterdam-netherlands","lorenskog-norway","m-laga-spain","madrid-spain","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Phase 1 / Phase 2: testing MK-3120 for Bladder Cancer","inPlainEnglish":"Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder and has not spread to the bladder muscle or outside of the bladder.","whoItsFor":["Ages 18 Years to any","Has histologically confirmed carcinoma in situ (CIS) +/- papillary high-risk non-muscle invasive bladder cancer (NMIBC), confirmed locally","Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy","Participants who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation","Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"],"whoShouldSkip":["Has history of or current locally advanced (ie, T2, T3, T4) or metastatic urothelial cancer (UC)","Has concurrent extravesical (ie, urethra, ureter, renal pelvis) non-muscle invasive UC or history of extravesical non-muscle invasive UC that recurred within the last 2 years","Has active total bladder incontinence, active urinary tract infection, neurogenic bladder, or urethral stricture","Has a condition that would prohibit normal voiding (or holding bladder voiding for 1 to 2 hours)","Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has known additional malignancy that is progressing or has required active treatment within the past 3 years"],"whatHappens":"If you join, the listed intervention(s) are MK-3120. The registry lists allocation as na. Researchers are looking for new ways to treat high-risk non-muscle invasive bladder cancer (HR NMIBC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 45 people at 17 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.287Z"},{"nctId":"NCT07222761","title":"A Study to Compare Linvoseltamab Monotherapy and Linvoseltamab + Carfilzomib Combination Therapy With Standard-of-Care Combination Regimens in Adult Participants With Relapsed/Refractory Multiple Myeloma (RRMM)","officialTitle":"An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching a drug called linvoseltamab (also called \"study drug\") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.\n\nThe aim of this study is to see if the safety and efficacy of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)","conditions":["Relapsed and/or Refractory Multiple Myeloma (RRMM)"],"keywords":["BCMA X CD3 Bispecific Monoclonal Antibody","Bispecific combination therapy","Linvoseltamab","Carfilzomib","Proteasome inhibitor"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"},{"type":"DRUG","name":"Carfilzomib"},{"type":"DRUG","name":"Daratumumab"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Bortezomib"}],"enrollment":915,"startDate":"2026-01-02","completionDate":"2029-05-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody\n2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2\n3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy\n\nKey Exclusion Criteria:\n\n1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded\n2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)\n3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement\n4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"Emory Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stony Brook University Hospital","city":"Stony Brook","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OhioHealth","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor University Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center, Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pindara Private Hospital","city":"Benowa","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Misericordiae Ltd","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gold Coast Hospital and Health Service","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epworth Freemasons","city":"East Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Hospital","city":"Heidelberg","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alfred Hospital","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Perth Hospital","city":"Perth","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital","city":"Adelaide","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cetus Oncologia","city":"Belo Horizonte","state":"Minas Gerais","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Erasto Gaertner","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncomed Clinica Oncologica","city":"Niterói","state":"Rio de Janeiro","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Clinicas de Porto Alegre","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Gaucho Integrado, Hospital Mae de Deus","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Hematologia e Oncologia","city":"Joinville","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"ANIMI","city":"Lages","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unidade de Pesquisa Clinica (UPC); Hospital das Clinicas de Ribeirao Preto da Universidade de Sao Paulo","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"AC Camargo Cancer Center","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Medica Sao Germano","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universidad de Los Andes","city":"Santiago","state":"Las Condes","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Alemana de Santiago","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica UC San Carlos de Apoquindo","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"OncoPrecision","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Clinicas Vina del Mar","city":"Viña del Mar","state":"Valparaiso","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chonnam National University Hwasun Hospital","city":"Hwasun","state":"Jeollanam-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital; Division of Hematology","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul St. Mary's Hospital, The Catholic University of Korea","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ulsan University Hospital","city":"Ulsan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital - Linkou Branch","city":"Taoyuan","state":"Hunan Province","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Municipal Wan Fang Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara University Faculty of Medicine","city":"Mamak","state":"Ankara","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Liv Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Florence Nightingale Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Izmir Ekonomi Universitesi (IEU) Medical Point Izmir Hastanesi (Izmir Economy University Medical Point Izmir Hospital)","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aberdeen Royal Infirmary","city":"Aberdeen","state":"Aberdeenshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Cornwall Hospital National Health Service (NHS) Foundation Trust","city":"Truro","state":"Cornwall","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology","city":"Plymouth","state":"Devon","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust","city":"Norwich","state":"Norfolk","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden National Health Service (NHS) Foundation Trust; Royal Marsden Hospital","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Birmingham NHS Trust, Center for Clinical","city":"Birmingham","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ninewells Hospital and Medical School","city":"Dundee","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Manchester, Manchester Royal Infirmary","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Occurrence of Treatment Emergent Adverse Events (TEAEs)","Severity of TEAEs","Occurrence of Adverse Events of Special Interest (AESI)","Severity of AESIs","Occurrence of Serious Adverse Events (SAEs)","Severity of SAEs","Minimal Residual Disease (MRD)-negative Complete Response (CR)","Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC"],"hasResults":false,"conditionSlugs":["multiple-myeloma","als"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","new-york-new-york","stony-brook-new-york","columbus-ohio","dallas-texas","houston-texas","benowa-australia","brisbane-australia","southport-australia","east-melbourne-australia","heidelberg-australia","melbourne-australia","perth-australia","adelaide-australia","belo-horizonte-brazil","curitiba-brazil","niter-i-brazil","porto-alegre-brazil","joinville-brazil","lages-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","santiago-chile","vi-a-del-mar-chile","hwasun-south-korea","seoul-south-korea","ulsan-south-korea","taoyuan-taiwan","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","mamak-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","aberdeen-united-kingdom","truro-united-kingdom","plymouth-united-kingdom","norwich-united-kingdom","sutton-united-kingdom","birmingham-united-kingdom","dundee-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Linvoseltamab for Relapsed and/or Refractory Multiple Myeloma (RRMM)","inPlainEnglish":"This study is researching a drug called linvoseltamab (also called \"study drug\") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies. The aim of this study is to see if the safety and how well it works of linvoseltamab alone or in combination with carfilzomib can deliver better outcomes (deeper and longer responses that help extend life) than standard treatment options.","whoItsFor":["Ages 18 Years to any","Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody","Eastern Cooperative Oncology Group (ECOG) performance status score ≤2","Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy"],"whoShouldSkip":["Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded","Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)","Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement","History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder","NOTE: Other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Linvoseltamab, Carfilzomib, or Daratumumab. The registry lists allocation as randomized. This study is researching a drug called linvoseltamab (also called \"study drug\") either given alone or in combination with another anti-myeloma drug called carfilzomib, compared to several standard treatments for progressive Multiple Myeloma (MM) after at least 1 but no more than 3 prior therapies.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 915 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.515Z"},{"nctId":"NCT07222943","title":"Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","officialTitle":"Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Baylor College of Medicine","sponsorClass":"OTHER","summary":"Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.\n\nParticipants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.\n\nThis intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.","conditions":["Functional Abdominal Pain Disorders","Irritable Bowel Syndrome (IBS)","Functional Gastrointestinal Disorders (FGIDs)","Gastrointestinal and Digestive Disorder","Abdominal Pain/ Discomfort","Pain","Functional Dyspepsia"],"keywords":["abdominal pain","irritable bowel syndrome"],"interventions":[{"type":"BEHAVIORAL","name":"Guided Imagery Therapy"}],"enrollment":63,"startDate":"2026-09-08","completionDate":"2027-04-30","sex":"ALL","minAge":"7 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Texas Children's Pediatrics patients 7 to 12 years old at enrollment\n* A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary\n* Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.\n\nExclusion Criteria:\n\n* Previous abdominal surgeries\n* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)\n* Autism\n* Significant development delay\n* Psychosis\n* Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain\n* Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)","locations":[{"facility":"Baylor College of Medicine/Texas Children's Hospital","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine / Texas Children's Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hollier, MD","phone":"832-824-3814","email":"GITgoStudy@bcm.edu"}],"primaryOutcomes":["Abdominal Pain Intensity"],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["austin-texas","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Guided Imagery Therapy for Functional Abdominal Pain Disorders","inPlainEnglish":"Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies.","whoItsFor":["Ages 7 Years to 12 Years","Texas Children's Pediatrics patients 7 to 12 years old at enrollment","A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary","Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments"],"whoShouldSkip":["Previous abdominal surgeries","Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)","Significant development delay","Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain","Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)"],"whatHappens":"If you join, the listed intervention(s) are Guided Imagery Therapy. The registry lists allocation as na. Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 63 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.438Z"},{"nctId":"NCT07223021","title":"A Study of Fludarabine Dosing in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia","officialTitle":"Improving EveNt Free Survival by Optimizing FLUdarabine Exposure During LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (INFLUENCE)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective. The researchers will also look at whether PK-targeted fludarabine dosing is feasible (practical), the side effects of the study treatment, and how the study treatment affects people's quality of life. The researchers will measure quality of life by having participants complete questionnaires.","conditions":["B-cell Acute Lymphoblastic Leukemia"],"keywords":["Fludarabine"],"interventions":[{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"},{"type":"BIOLOGICAL","name":"CAR-T"}],"enrollment":130,"startDate":"2025-10-20","completionDate":"2028-10","sex":"ALL","minAge":"1 Year","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with B-ALL and eligible to receive commercial tisagenlecleucel.\n* Patient's weight \\> 9 kg at time of lymphodepleting chemotherapy\n* Adequate organ function at time of LD is required and is defined:\n\n  * Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia\n  * Hepatic: AST and ALT \\< 5x the upper limit of normal for age, unless thought to be leukemic disease-related\n  * Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml/min/1.73m\\^2. (based on Schwartz formula GFR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in mg/dL\n  * Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening\n  * Pulmonary: Oxygen saturation as recorded by pulse oximetry of ≥ 90% on room air\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnofsky \\> 60% at treatment\n  * Age \\< 16 years: Lansky ≥ 60% at treatment\n* Willing to participate as research subject and provide written informed consent from parents/legal representative, patient, and age-appropriate assent as appropriate before any study specific screening procedures are conducted, according to local, regional or national law and legislation.\n\nExclusion Criteria:\n\n* Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel.\n* Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol\n* Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)\n* Patient/parent/guardian unable to give informed consent or unable to comply with the treatment protocol.\n* Pregnant or lactating women","locations":[{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College Medical Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Texas Children's Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Children's Hospital Münster (Data Analysis)","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prinses Máxima Centrum (Data Analysis)","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kevin Curran, MD","phone":"1-833-MSK-KIDS","email":"currank@mskcc.org"},{"name":"Jaap Jan Boelens, MD, PhD","phone":"1-833-MSK-KIDS","email":""}],"primaryOutcomes":["compare the event free survival (EFS )"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":["car-t"],"locationSlugs":["new-york-new-york","cincinnati-ohio","philadelphia-pennsylvania","memphis-tennessee","houston-texas","m-nster-germany","utrecht-netherlands"],"enrichment":{"headline":"Phase 3: testing Fludarabine for B-cell Acute Lymphoblastic Leukemia","inPlainEnglish":"The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy. The researchers will compare PK-targeted fludarabine dosing with standard fludarabine dosing to see which treatment approach is more effective.","whoItsFor":["Ages 1 Year to any","Patients with B-ALL and eligible to receive commercial tisagenlecleucel","Patient's weight \\> 9 kg at time of lymphodepleting chemotherapy","Adequate organ function at time of LD is required and is defined:","Hepatic: Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia","Hepatic: AST and ALT \\< 5x the upper limit of normal for age, unless thought to be leukemic disease-related","Renal: Calculated glomerular filtration rate (GFR) ≥ 70 ml/min/1.73m\\^2. (based on Schwartz formula GFR (mL/min/1.73 m²) = (36.2 × Height in cm) / Creatinine in mg/dL","Cardiac: LVEF ≥ 50% by multi-gated acquisition scan (MUGA), resting echocardiogram, or cardiac magnetic resonance imaging (MRI) within 6 weeks of screening"],"whoShouldSkip":["Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drugs, or drugs chemically related to study treatment or excipients that contraindicate their participation, including fludarabine, cyclophosphamide and tisagenlecleucel","Patients with tisagenlecleucel that is deemed out of specification (OOS) will be excluded from this protocol","Clinically significant active and uncontrolled infection confirmed by clinical evidence, imaging, or positive laboratory tests (e.g., blood cultures, PCR for DNA/RNA etc.)","Pregnant or lactating women"],"whatHappens":"If you join, the listed intervention(s) are Fludarabine, Cyclophosphamide, or Fludarabine. The registry lists allocation as randomized. The researchers are doing this study to find out whether PK-targeted fludarabine is an effective Lymphodepletion (LD) chemotherapy approach for people with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who will receive tisagenlecleucel CAR T-cell therapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 130 people at 8 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.403Z"},{"nctId":"NCT07224256","title":"VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration","officialTitle":"VOICE: An Early Feasibility Study of a Precise Robotically Implanted Brain-Computer Interface for Communication Restoration","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Neuralink Corp","sponsorClass":"INDUSTRY","summary":"The VOICE Study is an early feasibility study to evaluate the initial clinical safety and efficacy of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment. It is indicated for adults with neurological conditions of the central speech pathways who have impaired upper limb function. The N1 Implant is a skull-mounted, wireless, rechargeable implant connected to electrode threads that are implanted in the brain by the R1 Robot, a robotic electrode thread inserter.","conditions":["Tetraplegia/Tetraparesis","Quadriplegia","Cervical Spinal Cord Injury","Amyotrophic Lateral Sclerosis","Quadriplegia/Tetraplegia","Tetraplegic; Paralysis","Stroke"],"keywords":["stroke","spinal cord injury","SCI","ALS","brain computer interface","BCI","PLS","voice","speech","dysarthria","neuralink"],"interventions":[{"type":"DEVICE","name":"N1 Implant"},{"type":"DEVICE","name":"R1 Robot"}],"enrollment":6,"startDate":"2025-10-03","completionDate":"2028-10","sex":"ALL","minAge":"22 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAdults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function.\n\n* Life expectancy ≥ 12 months.\n* Ability to communicate in English\n* Presence of a stable caregiver\n\nExclusion Criteria\n\n* Moderate to high risk for serious perioperative adverse events\n* Morbid obesity (Body Mass Index \\> 40)\n* History of poorly controlled seizures or epilepsy\n* History of poorly controlled diabetes\n* Requires magnetic resonance imaging (MRI) for any ongoing medical conditions\n* Acquired or hereditary immunosuppression\n* Psychiatric or psychological disorder\n* Brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.\n* Any condition which, in the opinion of the Investigator, would compromise your ability to safely participate in the study or undergo the implantation procedure","locations":[{"facility":"The University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Neuralink Clinical Team","phone":"+1 (650) 250-0520","email":"voice-study@neuralink.com"}],"primaryOutcomes":["Device-Related Adverse Events (AE)","Procedure-Related Adverse Events (AE)"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["dallas-texas"],"enrichment":{"headline":"Not a traditional drug phase: N1 Implant for Tetraplegia/Tetraparesis","inPlainEnglish":"The VOICE Study is an early feasibility study to measure the initial clinical safety and how well it works of the N1 and R1 Systems device design concept in providing an ability to communicate. The Neuralink N1 Implant is intended to provide the ability to communicate to individuals with severe and irreversible speech production impairment.","whoItsFor":["Ages 22 Years to 75 Years","Adults with diagnosis of ALS, PLS, stroke, or Spinal Cord Injury who have severe speech impairment and impaired upper limb function","Life expectancy ≥ 12 months","Ability to communicate in English","Presence of a stable caregiver"],"whoShouldSkip":["Moderate to high risk for serious perioperative side effects","Morbid obesity (Body Mass Index \\> 40)","History of poorly controlled seizures or epilepsy","History of poorly controlled diabetes","Requires magnetic resonance imaging (MRI) for any ongoing medical conditions","Acquired or hereditary immunosuppression","Psychiatric or psychological disorder"],"whatHappens":"If you join, the listed intervention(s) are N1 Implant, or R1 Robot. The registry lists allocation as na. The VOICE Study is an early feasibility study to measure the initial clinical safety and how well it works of the N1 and R1 Systems device design concept in providing an ability to communicate.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 6 people at Dallas. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.597Z"},{"nctId":"NCT07224360","title":"Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease (SCD)","officialTitle":"Phase 2a, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety of Anumigilimab (CSL324) in Adults With Sickle Cell Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"CSL Behring","sponsorClass":"INDUSTRY","summary":"This is a phase 2a, global, multicenter, randomized, double-blind, placebo-controlled study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.\n\nThe primary aim of the study is to assess the safety of anumigilimab in participants with SCD. Participants will be treated for 64 weeks: for 12 weeks in the dose escalation period, where the dose will be escalated to each participant's individual MTD; and for 52 weeks at the MTD in the maintenance period.","conditions":["Sickle Cell Disease"],"keywords":["Anemia","Genetic Disorder","Vaso-occlusive Crises"],"interventions":[{"type":"BIOLOGICAL","name":"Anumigilimab"},{"type":"DRUG","name":"Placebo"}],"enrollment":63,"startDate":"2026-02-02","completionDate":"2028-08-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged greater than or equal to (\\>=) 18 years on the day of signing the informed consent form.\n* Confirmed diagnosis of SCD of any genotype.\n* Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening.\n* HU Regimen:\n* a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening.\n* or\n* b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect).\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than (\\<) 2.5 ×10\\^9 cells/Litre at Screening or Baseline (Week 1 Day 1).\n* If on SCD preventive medication, dose is not stable in the 30 days before Screening.","locations":[{"facility":"UAMS Medical Center","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Foundation for Sickle Cell Disease","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur M. Blank Hospital- Children's Healthcare of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Cancer and Blood Disorders","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Specialty Research","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYC Health + Hospitals/Queens","city":"Jamaica","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jacobi Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Physicians Comprehensive Adult Sickle Cell Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Antwerpen","city":"Edegem","state":"Antwerp","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Saint-Pierre","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HM Hôpital de La Timone","city":"Marseille","state":"Bouches-du-Rhône","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nantes, Hotel-Dieu","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Rouen-Hôpital Charles-Nicolle","city":"Rouen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Universitaire du Cancer de Toulouse","city":"Toulou","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale Sant' Anna","city":"Cona","state":"Ferrara","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Giannina Gaslini","city":"Genoa","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo dei Tintori","city":"Monza","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AORN Antonio Cardarelli","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Bambino Gesù Children's Hospital","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOUI Verona and University of Verona","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC - VUmc","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"VM Medical Park Mersin Hospital","city":"Mezitli","state":"Mersin","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mersin University Medical Faculty","city":"Yenişehir","state":"Mersin","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Acibadem Adana Hastanesi","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe University Medical Faculty","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manchester Royal Infirmary","city":"Manchester","state":"England","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Liverpool University Hospital","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal London Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Middlesex Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St George's University Hopsitals NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Registration Coordinator","phone":"+1 610-878-4697","email":"clinicaltrials@cslbehring.com"}],"primaryOutcomes":["Number of participants with Treatment Emergent Adverse Events (TEAEs), Overall and by severity, seriousness and relationship to Investigational Product (IP)","Percentage of participants with TEAEs Overall and by severity, seriousness and relationship to IP","Number of participants with Adverse Events of Special Interest (AESI)","Percentage of participants with AESI","Number of participants with clinically relevant changes from baseline in laboratory assessments and vital signs","Percentage of participants with clinically relevant changes from baseline in laboratory assessments and vital signs"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","orange-california","hollywood-florida","atlanta-georgia","bethesda-maryland","boston-massachusetts","minneapolis-minnesota","flowood-mississippi","jamaica-new-york","new-york-new-york","the-bronx-new-york","columbus-ohio","houston-texas","richmond-virginia","edegem-belgium","brussels-belgium","marseille-france","nantes-france","rouen-france","toulou-france","cona-italy","genoa-italy","monza-italy","naples-italy","rome-italy","verona-italy","amsterdam-netherlands","mezitli-turkey-t-rkiye","yeni-ehir-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","manchester-united-kingdom","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Anumigilimab for Sickle Cell Disease","inPlainEnglish":"This is a phase 2a, global, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD. The primary aim of the study is to assess the safety of anumigilimab in participants with SCD.","whoItsFor":["Ages 18 Years to any","Confirmed diagnosis of SCD of any genotype","Experienced 1 to 12 VOCs requiring a visit to a medical facility and treatment with parenteral opioids or a parenteral nonsteroidal anti-inflammatory drug within the 12 months before Screening","a. On stable and well-tolerated Hydroxyurea (HU) regimen for at least 30 days before Screening","b. HU was discontinued or refused (eg, due to concern of side effects or lack of effect)"],"whoShouldSkip":["Absolute neutrophil count less than (\\<) 2.5 ×10\\^9 cells/Litre at Screening or Baseline (Week 1 Day 1)","If on SCD preventive medication, dose is not stable in the 30 days before Screening"],"whatHappens":"If you join, the listed intervention(s) are Anumigilimab, or Placebo. The registry lists allocation as randomized. This is a phase 2a, global, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study investigating the safety of anumigilimab administered subcutaneously (SC) at the maximum tolerated dose (MTD) in adult participants with SCD.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 63 people at 38 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.835Z"},{"nctId":"NCT07226206","title":"A Gene Therapy Study of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A","officialTitle":"A Phase 2b, Single-Arm, Open-Label, Multicenter Study of the Safety of SPK-8011QQ in Adults With Severe or Moderately Severe Hemophilia A","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study will assess the safety and tolerability of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.","conditions":["Hemophilia A"],"keywords":[],"interventions":[{"type":"DRUG","name":"SPK-8011QQ"}],"enrollment":5,"startDate":"2026-09-08","completionDate":"2032-04-30","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed Informed Consent Form (ICF)\n* ≥18 years of age at the time of signing the ICF\n* Male sex assigned at birth\n* Severe or moderately severe hemophilia A, defined as endogenous FVIII:C activity levels ≤3%, as documented (historically or during the Screening Period) by a certified laboratory and where the FVIII:C level is measured more than 96 hours after the prior dose of an extended half-life FVIII replacement product or more than 72 hours after the prior dose of a standard half-life FVIII replacement product\n* Have documented treatment for a minimum of 6 months prior to screening with either of the following: plasma coagulation factor VIII (FVIII) prophylaxis, defined as receiving a prescribed dose and frequency of FVIII infusions with the intent to treat continuously for 52 weeks per year; or FVIII on demand, with a history of ≥ 5 breakthrough bleeds in the 6 months prior to screening\n* No prior history of hypersensitivity or anaphylaxis associated with the administration of any FVIII product\n* Have ≥150 exposure days to a FVIII protein product such as recombinant, plasma-derived, or extended half-life FVIII product\n* Negative screening test for inhibitor against FVIII (i.e., \\<0.6 BU)\n* Candidates with prior FVIII inhibitors who are tolerized having completed successful ITI at least 5 years before screening are eligible provided they have had no evidence of inhibitor recurrence (permanent or temporary) within 5 years prior to screening as may be indicated by detection of an inhibitor, FVIII half-life \\<6 hours, or FVIII recovery \\<66% since completing ITI\n* Confirmed negative anti-Spark200 antibodies as documented through central laboratory testing of a serum sample\n* Acceptable hepatobiliary function according to all of the following criteria: ALT, AST, and ALP ≤2×ULN and INR \\<1.4 at the time of screening; No evidence of cirrhosis or advanced liver disease on screening liver ultrasound; Otherwise no laboratory or clinical evidence of liver disease or cirrhosis, per the Investigator's judgement\n* Adequate renal function, defined as creatinine clearance ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration formula; patients on dialysis are not eligible for the study\n* Platelet count ≥50,0000 cells/µL\n* Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on an antiretroviral treatment regimen, have a cluster of differentiation (CD4) count \\>200/mm3, and undetectable viral load (\\<50 gc/mL)\n* Negative hepatitis B surface antigen (HBsAg) at screening\n* Positive hepatitis surface antibody (HBsAb) at screening, or a negative HBsAb at screening accompanied by either of the following: Negative hepatitis B core antibody (HBcAb); Positive HBcAb and negative hepatitis B virus (HBV) DNA test\n* Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test at screening accompanied by negative HCV RNA test\n* Otherwise appropriate medical history and physical and laboratory evaluation that are acceptable for inclusion in this clinical trial\n* Are able and willing to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures, including the completion of applicable patient-reported outcome questionnaires\n* Agreement to adhere to the contraception requirements described in the protocol\n\nExclusion Criteria:\n\n* Are currently undergoing antiviral therapy for chronic hepatitis B or chronic hepatitis C\n* Have an inherited or acquired bleeding disorder other than hemophilia A\n* Have known inherited or acquired thrombophilia, have signs of thromboembolic disease in the Investigator's judgement, or are on current treatment for thromboembolic disease. A history of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing is not considered an exclusion criterion\n* Have had prior treatment with a vector or gene transfer agent. Nucleic acid-based vaccines, such as the vaccine for coronavirus disease 2019 (COVID-19), are not considered gene transfer agents\n* Are receiving an investigational drug concurrently or have received an investigational drug within 30 days or 5 half-lives of the last investigational drug administration, whichever is longer\n* Have a major surgical procedure planned in the 15-month period following SPK-8011QQ infusion\n* Are unable (or unwilling) to receive blood or blood products (or any standard-of-care treatment for a life-threatening condition)\n* Have concurrent disease, treatment, or abnormality in clinical laboratory tests that could interfere with the conduct of the study or that would, in the opinion of the Investigator preclude the candidate's safe participation in and completion of the study, or the interpretation of the study results\n* History of malignancy within 5 years prior to screening and up to investigational study drug administration (Day 1) with the following exceptions: Participants with curatively treated basal or squamous cell carcinoma of the skin at any time prior to investigational study drug administration (Day 1) are eligible","locations":[{"facility":"Center for Inherited Blood Disorders","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente","city":"Vallejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Newark Beth Israel Medical Center","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Presbyterian Hospital - Weill-Cornell","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: XO46084 https://forpatients.roche.com/ No email attachments.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Incidence of participants with adverse events (AEs)","Severity of AEs as determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 grading scale","Incidence of adverse events of special interest (AESIs)","Incidence of serious adverse events (SAEs)","Incidence of treatment-related AEs","Number of participants with abnormal laboratory values"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["orange-california","san-francisco-california","vallejo-california","new-haven-connecticut","newark-new-jersey","new-york-new-york"],"enrichment":{"headline":"Phase 1 / Phase 2: testing SPK-8011QQ for Hemophilia A","inPlainEnglish":"This study will assess the whether it is safe and how hard side effects are to live with of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.","whoItsFor":["Ages 18 Years to any","Men only","≥18 years of age at the time of signing the ICF","Male sex assigned at birth","No prior history of hypersensitivity or anaphylaxis associated with the administration of any FVIII product","Have ≥150 exposure days to a FVIII protein product such as recombinant, plasma-derived, or extended half-life FVIII product","Negative screening test for inhibitor against FVIII (i.e., \\<0.6 BU)","Confirmed negative anti-Spark200 antibodies as documented through central laboratory testing of a serum sample","Adequate renal function, defined as creatinine clearance ≥30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration formula; patients on dialysis are not eligible for the study"],"whoShouldSkip":["Are currently undergoing antiviral therapy for chronic hepatitis B or chronic hepatitis C","Have an inherited or acquired bleeding disorder other than hemophilia A","Have had prior treatment with a vector or gene transfer agent. Nucleic acid-based vaccines, such as the vaccine for coronavirus disease 2019 (COVID-19), are not considered gene transfer agents","Are receiving an investigational drug concurrently or have received an investigational drug within 30 days or 5 half-lives of the last investigational drug administration, whichever is longer","Have a major surgical procedure planned in the 15-month period following SPK-8011QQ infusion","Are unable (or unwilling) to receive blood or blood products (or any standard-of-care treatment for a life-threatening condition)"],"whatHappens":"If you join, the listed intervention(s) are SPK-8011QQ. The registry lists allocation as na. This study will assess the whether it is safe and how hard side effects are to live with of SPK-8011QQ in adult males with moderately severe to severe hemophilia A.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 5 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.071Z"},{"nctId":"NCT07226232","title":"Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression","officialTitle":"A Multi-site Randomized Controlled Trial of Psilocybin for Treatment-Resistant Depression (TRD) in Veterans","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"VA Office of Research and Development","sponsorClass":"FED","summary":"The purpose of this multi-site randomized controlled trial is to evaluate the efficacy and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.","conditions":["Major Depression"],"keywords":["depression","psilocybin","veterans","post-traumatic stress disorder"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Psilocybin"}],"enrollment":240,"startDate":"2026-08-03","completionDate":"2030-12-02","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Veteran of the U.S. military who is English-speaking\n* Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA)\n* Adults \\</= 75 years of age\n* Meets DSM-5 criteria for current major depressive episode (MDE)\n* Montgomery-Asberg Rating Scale (MADRS)\\>/= 20 at baseline\n* Failure to respond satisfactorily to \\>/= 2 antidepressant treatments for \\>/= 8 weeks, including \\>/= 2 weeks at an adequate dose (\\>/= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.\n* If applicable, concurrent \\& permitted antidepressants must be at stable doses for \\>/= 4 weeks prior to baseline (see allowed \\& prohibited medication list)\n* Participants of child-bearing potential must have negative pregnancy test \\& agree to adhere to a medically acceptable method of birth control during the study\n* Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration\n\nExclusion Criteria:\n\n* Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders\n* First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder\n* Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)\n* Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)\n* Severe alcohol and/or cannabis use disorder within the past 6 months (mild or moderate alcohol and/or cannabis use is allowed at the discretion of the LSI)\n* Lifetime hallucinogen persisting perception or hallucinogen use disorders\n* Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past XX months\n* Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol\n* Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)\n* History of severe traumatic brain injury (TBI)\n* Diagnosis of dementia or related progressive neurocognitive disorder\n* Suicidal ideation/behavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline\n* Psychiatric inpatient treatment within past 3 months of baseline\n* Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline\n* Implanted central nervous system device\n* Treatment with evidence-based psychotherapy (EBP) for MDD or PTSD within 2 weeks prior to baseline. If receiving EBP therapy, he/she must complete treatment at least 2 weeks prior to baseline. Other forms of non-EBP psychotherapy for MDD or PTSD are allowed to continue during the study period.\n* Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase\n* History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and/or severe cardiac disease\n* Clinically significant cardiac, pulmonary, renal, liver and/or other medical disease that, in the opinion of the investigator, may contraindicate the use of psilocybin, interfere with the interpretation of study results and/or constitute a health risk for the participant if they take part in the study\n* Seizure disorder, except for seizures due to fever or withdrawal from a substance\n* Clinically significant hypertension (\\>160/95 mmHg), hypotension (\\<90/60 mmHg) tachycardia (\\>100 bpm at rest), QTc prolongation (\\>450 msec men; \\>470 msec women) or clinically significant arrhythmia on ECG\n* Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and/or thyroid stimulating hormone\n* Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline\n* Prior allergic, adverse reaction or adverse experience to a psilocybin formulation\n* Litigating for disability income for a mental disorder outside the VA compensation and pension process","locations":[{"facility":"Birmingham VA Medical Center, Birmingham, AL","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tuscaloosa VA Medical Center, Tuscaloosa, AL","city":"Tuscaloosa","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VA Portland Health Care System, Portland, OR","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VA Puget Sound Health Care System Seattle Division, Seattle, WA","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lori L Davis, MD AB","phone":"(205) 554-3819","email":"lori.davis@va.gov"},{"name":"Anchal Ghera, MS","phone":"(205) 899-1273","email":"anchal.ghera@va.gov"}],"primaryOutcomes":["Montgomery-Asberg Rating Scale (MADRS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["birmingham-alabama","tuscaloosa-alabama","portland-oregon","philadelphia-pennsylvania","seattle-washington"],"enrichment":{"headline":"Phase 3: testing Psilocybin for Major Depression","inPlainEnglish":"The purpose of this multi-site randomly assigned controlled trial is to measure the how well it works and risks of psilocybin for the treatment of depression in U.S. military Veterans with and without (±) concurrent posttraumatic stress disorder.","whoItsFor":["Ages 18 Years to 75 Years","Veteran of the U.S. military who is English-speaking","Adults \\</= 75 years of age","Meets DSM-5 criteria for current major depressive episode (MDE)","Montgomery-Asberg Rating Scale (MADRS)\\>/= 20 at baseline","If applicable, concurrent \\& permitted antidepressants must be at stable doses for \\>/= 4 weeks prior to baseline (see allowed \\& prohibited medication list)","Participants of child-bearing potential must have negative pregnancy test \\& agree to adhere to a medically acceptable method of birth control during the study","Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration"],"whoShouldSkip":["Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders","First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder","Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)","Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)","Severe alcohol and/or cannabis use disorder within the past 6 months (mild or moderate alcohol and/or cannabis use is allowed at the discretion of the LSI)","Lifetime hallucinogen persisting perception or hallucinogen use disorders","Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past XX months"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, or Psilocybin. The registry lists allocation as randomized. The purpose of this multi-site randomly assigned controlled trial is to measure the how well it works and risks of psilocybin for the treatment of depression in U.S.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 240 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.413Z"},{"nctId":"NCT07226453","title":"Target Validation and Efficacy of Metformin in Patients With Posterior Fossa Group A (PFA) Ependymoma","officialTitle":"A Target Validation and Efficacy Study of Metformin in Patients With Recurrent or Progressive Posterior Fossa Group A (PFA) Ependymoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"This is a multi-site study of the pharmacodynamic effects and efficacy of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.","conditions":["Posterior Fossa Ependymal Tumor"],"keywords":[],"interventions":[{"type":"DRUG","name":"Metformin"},{"type":"PROCEDURE","name":"Planned Surgical Resection"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging (MRI)"},{"type":"PROCEDURE","name":"Specimen Collection"},{"type":"PROCEDURE","name":"MR spectroscopy (MRS)"}],"enrollment":30,"startDate":"2026-05-05","completionDate":"2028-04-30","sex":"ALL","minAge":"1 Year","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants must have recurrent or progressive posterior fossa A (PFA) ependymoma following surgery AND radiation treatment (RT).\n2. Participants must have a diagnosis of PFA ependymoma. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria.\n3. Participants must have adequate tumor tissue available from initial diagnosis or from pre- trial enrollment. Formalin-fixed paraffin-embedded (FFPE) material (1 full block) should be provided. If FFPE material is not available, 10 unstained slides with an accompanying hematoxylin and eosin (H\\&E) report should be provided.\n\n   Target Validation (TV) Phase:\n\n   o Participants are candidates to undergo elective surgery for removal of all or a portion of their recurrent/progressive tumor.\n\n   Efficacy Phase:\n   * Participant must have measurable disease; this will be defined as lesions that can be accurately measured in two dimensions (longest diameter to be recorded) The size threshold is met if both in-plane diameters are ≥10 mm or both in-plane diameters are at least two times the MRI slice thickness, plus the interslice gap with a minimum size of no less than double the slice thickness on MRI.\n   * Participants with an isolated local progression of the tumor following RT (or stereotactic radiosurgery, SRS) must be \\> 6 months from completion of RT to the lesion to rule out pseudo progression or must have tissue confirmation of progression prior to enrollment.\n   * Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy as outlined above.\n4. Prior Therapy: Participants must not be receiving metformin for other medical indications or previous exposure to metformin following their diagnosis of PFA ependymoma. However, participants treated on the TV phase, but did not continue onto maintenance therapy will be allowed to enroll on the efficacy phase with future recurrences or progression of their disease.\n5. Age: 1 -39 years at the time of enrollment.\n6. Performance Score: Karnofsky \\>= 50 for participants \\> 16 years of age and Lansky \\>=50 for participants \\<=16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n7. Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration.\n8. Organ Function Requirements\n\n   1. Peripheral absolute neutrophil count (ANC) \\>= 1000/mm\\^3.\n   2. Platelet count \\>=100,000/mm\\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n   3. Serum creatinine \\< 1.5 Upper Limit normal (ULN) based on age and gender\n   4. Total bilirubin \\<= 1.5 x ULN for age; in presence of Gilbert's syndrome, total bilirubin \\< 3 x ULN or direct bilirubin \\< 1.5 x ULN\n   5. alanine aminotransferase (ALT) \\<= 3 x ULN.\n   6. aspartate aminotransferase (AST) \\<=3 x ULN.\n9. Participants with seizure disorder may be enrolled if well controlled and are on stable dose of anti-seizure medication for \\> 72 hours prior to enrollment. Participants who have neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.\n10. Participants must enroll on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution.\n11. A legal parent/guardian or participant must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n\nExclusion Criteria:\n\n1. Participants with a history of diabetes mellitus or those meeting criteria for pre-diabetes are excluded. Pre-diabetes is defined per American Diabetes Association criteria as any of the following: fasting plasma glucose (FPG) 100-125 mg/dL (5.6-6.9 mmol/L); 2-hour plasma glucose (OGTT) 140-199 mg/dL (7.8-11.0 mmol/L); or hemoglobin A1c (HbA1c) 5.7%-6.4% (39-47 mmol/mol).\n2. Participants without any measurable disease.\n3. Participants who have had chemotherapy or have received radiotherapy to the non-target lesion within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n4. Participants must be at least 7 days since the completion of therapy with a biologic or small molecule agent. For any agent with known adverse events that can occur beyond 7 days after administration, the period prior to enrollment must be beyond the time during which adverse events are known to occur. Such participants should also be discussed with study chairs.\n5. Participants with rapidly progressive symptoms that require urgent surgery that in the investigators assessment cannot be safely deferred for 6 weeks are excluded from target validation phase of the study\n6. Participants who are receiving any other investigational agents.\n7. Concurrent radiation therapy in any form is not permitted while on the study drug\n8. History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin.\n9. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.\n10. Women of childbearing potential must not be pregnant or breast-feeding.\n11. Human immunodeficiency virus- (HIV) positive participants will be ineligible if HIV therapy regimen has not been stable for at least 4 weeks or there is intent to change the regimen within 8 weeks following enrollment, or if they are severely immunocompromised.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children at Indiana University Health","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack Meridian Health","city":"Hackensack","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Duke University","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GRAACC - Grupo de Apoio ao Adolescente e a Crianca com Cancer","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"PNOC Operations Office","phone":"415-502-1600","email":"PNOC041@ucsf.edu"}],"primaryOutcomes":["Proportion of participants with changes in biomarkers between the pre-and post-metformin treated samples (Target Validation Phase)","Disease Stabilization Rate (Efficacy Phase)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["birmingham-alabama","san-francisco-california","washington-d-c-district-of-columbia","indianapolis-indiana","baltimore-maryland","ann-arbor-michigan","st-louis-missouri","hackensack-new-jersey","durham-north-carolina","memphis-tennessee","salt-lake-city-utah","seattle-washington","s-o-paulo-brazil"],"enrichment":{"headline":"Phase 2: testing Metformin for Posterior Fossa Ependymal Tumor","inPlainEnglish":"This is a multi-site study of the pharmacodynamic effects and how well it works of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.","whoItsFor":["Ages 1 Year to 39 Years","Participants must have recurrent or progressive posterior fossa A (PFA) ependymoma following surgery AND radiation treatment (RT)","Participants must have a diagnosis of PFA ependymoma. Any number of previous recurrences are permissible provided the participant meets other enrollment criteria","Target Validation (TV) Phase:","o Participants are candidates to undergo elective surgery for removal of all or a portion of their recurrent/progressive tumor","Participants with an isolated local progression of the tumor following RT (or stereotactic radiosurgery, SRS) must be \\> 6 months from completion of RT to the lesion to rule out pseudo progression or must have tissue confirmation of progression prior to enrollment","Previously irradiated lesions are considered non-measurable except in cases of documented progression of the lesion since the completion of radiation therapy as outlined above","Age: 1 -39 years at the time of enrollment"],"whoShouldSkip":["Participants without any measurable disease","Participants with rapidly progressive symptoms that require urgent surgery that in the investigators assessment cannot be safely deferred for 6 weeks are excluded from target validation phase of the study","Participants who are receiving any other investigational agents","Concurrent radiation therapy in any form is not permitted while on the study drug","History of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin","Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection","Women of childbearing potential must not be pregnant or breast-feeding"],"whatHappens":"If you join, the listed intervention(s) are Metformin, Planned Surgical Resection, or Magnetic Resonance Imaging (MRI). The registry lists allocation as randomized. This is a multi-site study of the pharmacodynamic effects and how well it works of metformin in children and young adults with recurrent or progressive Posterior Fossa Group A (PFA) ependymoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at 13 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.572Z"},{"nctId":"NCT07227246","title":"Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2","officialTitle":"Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial - Part 2","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Joseph Broderick, MD","sponsorClass":"OTHER","summary":"The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.","conditions":["Intracerebral Hemorrhage"],"keywords":["Intracerebral hemorrhage","recombinant factor VIIa"],"interventions":[{"type":"BIOLOGICAL","name":"Recombinant Factor VIIa"},{"type":"BIOLOGICAL","name":"Biological/Vaccine: Placebo"}],"enrollment":350,"startDate":"2025-05-06","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients aged 18-80 years, inclusive\n2. Patients with spontaneous ICH\n3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign.\n4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, Finland, U.K., Japan, Australia)\n\nExclusion Criteria:\n\n1. Score of 3 to 7 on the Glasgow Coma Scale\n2. Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)\n3. ICH volume \\< 2 cc or ≥ 60 cc\n4. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.\n5. Pre-existing disability (mRS \\> 2)\n6. Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)\n7. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia\n8. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)\n9. Refusal to participate in study by patient, legal representative, or family member\n10. Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)\n11. Unfractionated heparin use with abnormal PTT\n12. Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)\n13. Low-molecular weight heparin use within the previous 24 hours\n14. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting\n15. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered\n16. Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment\n17. Planned withdrawal of care or comfort care measures\n18. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)\n19. Known or suspected allergy to trial medication(s), excipients, or related products\n20. Contraindications to study medication\n21. Previous participation in this trial (previously randomized)\n22. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment -","locations":[{"facility":"University of Alabama Hospital","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Baldwin Park Medical Center","city":"Baldwin Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mills Peninsula Medical Center","city":"Burlingame","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Downey Medical Center","city":"Downey","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Fontana Medical Center","city":"Fontana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente South Bay Medical Center","city":"Harbor City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSD Health La Jolla","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente West Los Angeles Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ronald Reagan UCLA Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Medical Center,","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente Riverside Medical Center","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Davis Medical Center","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSD Medical Center - Hillcrest Hospital","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Francisco General Hospital","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health Shands Hospital","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida Jacksonville (UF Health)","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United 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Scale"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","baldwin-park-california","burlingame-california","downey-california","fontana-california","harbor-city-california","la-jolla-california","los-angeles-california","orange-california","riverside-california","sacramento-california","san-diego-california","san-francisco-california","gainesville-florida","jacksonville-florida","atlanta-georgia","marietta-georgia","honolulu-hawaii","chicago-illinois","winfield-illinois","boston-massachusetts","worcester-massachusetts","detroit-michigan","burnsville-minnesota","edina-minnesota","maplewood-minnesota","minneapolis-minnesota","rochester-minnesota","st-louis-missouri","new-york-new-york","stony-brook-new-york","cincinnati-ohio","columbus-ohio","tulsa-oklahoma","portland-oregon","philadelphia-pennsylvania","charleston-south-carolina","greenville-south-carolina","houston-texas","salt-lake-city-utah","richmond-virginia","calgary-canada","edmonton-canada","vancouver-canada","winnipeg-canada","hamilton-canada","ottawa-canada","toronto-canada","montreal-canada","heidelberg-germany","erlangen-germany","frankfurt-am-main-germany","augsburg-germany","berlin-germany","hamburg-germany","t-bingen-germany","suita-japan","fukuoka-japan","gifu-japan","kagoshima-japan","kobe-japan","kyoto-japan","niigata-japan","osaka-japan","sapporo-japan","shimotsuke-japan","tokyo-japan","badalona-spain","horta-spain","lhospitalet-de-llobregat-spain","barcelona-spain","girona-spain","lleida-spain","valladolid-spain","oxford-united-kingdom","stoke-on-trent-united-kingdom","newcastle-upon-tyne-united-kingdom","nottingham-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Recombinant Factor VIIa for Intracerebral Hemorrhage","inPlainEnglish":"The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.","whoItsFor":["Ages 18 Years to 80 Years","Patients aged 18-80 years, inclusive","Patients with spontaneous ICH","Able to treat with study medication (rFVIIa/dummy treatment (placebo)) within 120 minutes of stroke onset or last known well with a positive spot sign on pretreatment CT angiography or treatment within 90 minutes with or without spot sign"],"whoShouldSkip":["Score of 3 to 7 on the Glasgow Coma Scale","Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)","ICH volume \\< 2 cc or ≥ 60 cc","Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles","Pre-existing disability (mRS \\> 2)","Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)","Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia"],"whatHappens":"If you join, the listed intervention(s) are Recombinant Factor VIIa, or Biological/Vaccine: Placebo. The registry lists allocation as randomized. The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 350 people at 88 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.224Z"},{"nctId":"NCT07227350","title":"L19IL2 or L19TNF or L19IL2/TNF in Patients With Basal Cell Carcinoma (BCC)","officialTitle":"A Phase 2 Controlled Randomized Study of the Efficacy of L19IL2 or L19TNF or L19IL2/L19TNF Intralesional Injections for the Treatment of Locally Advanced Basal Cell Carcinoma (LaBCC)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Philogen S.p.A.","sponsorClass":"INDUSTRY","summary":"Open label, randomized study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to evaluate the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate efficacy, safety and pharmacokinetics of immunocytokines. A minimum of 60 patients and a maximum of 180 evaluable patients will be randomized in a 1:1:1 ratio to one of the three different treatment arms of the study and will receive intralesional injections of: (i) Monotherapy 13 Mio IU (\\~2.17 mg) L19IL2; or (ii) Monotherapy 0.4 mg L19TNF; or (iii) Combination of 13 Mio IU L19IL2 + 0.4 mg L19TNF, once weekly for 4 consecutive weeks. Patients will be followed for a maximum of 156 weeks after beginning of treatment.","conditions":["Locally Advanced Basal Cell Carcinoma"],"keywords":["Basal Cell Carcinoma","locally advanced","subcutaneous lesions","cutaneous lesions"],"interventions":[{"type":"DRUG","name":"L19IL2"},{"type":"DRUG","name":"L19TNF"},{"type":"DRUG","name":"L19IL2/L19TNF"}],"enrollment":180,"startDate":"2026-09-28","completionDate":"2031-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with high risk, locally advanced histologically confirmed (non-metastatic, node negative, single or multifocal), BCC and amenable to intratumoral injection, not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.\n* Patients with at least one injectable and measurable cutaneous or subcutaneous lesion.\n* Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment.\n* Patients may have received prior surgery and/or radiation therapy.\n* Radiotherapy must have been previously administered for their locally advanced BCC, unless radiotherapy is contraindicated or inappropriate (e.g., hypersensitivity to radiation due to genetic syndrome such as Gorlin syndrome, limitations because of location of tumor, or cumulative prior radiotherapy dose). For patients whose locally advanced BCC has been irradiated, disease must have progressed after radiation.\n* Patients must have a histologically confirmed disease that is considered to be inoperable or medical contraindication to surgery or radiotherapy, in the opinion of a Mohs dermatologic surgeon, head and neck surgeon, plastic surgeon or surgical/medical oncologist. Acceptable medical contraindications to surgery include:\n\n  * BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely;\n  * Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);\n  * Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);\n  * Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient.\n* Prior radiotherapy to the target lesions must be completed at least 4 weeks prior to first study drug administration, with all acute RT-related toxicities resolved to ≤ Grade 1.\n* Male or female patients, who are capable of giving consent, age ≥ 18 years.\n* ECOG Performance Status/WHO Performance Status ≤ 1.\n* Hemoglobin \\> 10.0 g/dL.\n* Platelets \\> 100 x 109/L.\n* ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).\n* All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.\n* Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the \"Recommendations for contraception and pregnancy testing in clinical trials\" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomized partner.\n* Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.\n* Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.\n\nExclusion Criteria:\n\n* Presence of concomitant malignancies, with the exception of any cancer curatively treated more than 3 years prior to study entry and of tumors with a negligible risk for metastasis or death, such as adequately treated squamous-cell carcinoma of the skin (surgically removed 4 weeks prior to study entry), ductal carcinoma in situ of the breast, or carcinoma in situ of the cervix, early-stage asymptomatic CLL and not under active treatment (Rai 0, Binet A) will be eligible for the study.\n* Current topical or systemic chemotherapy, targeted therapy immunotherapy.\n* Patients with node positive BCC who are candidates for checkpoint inhibitor therapy.\n* Chronically impaired renal function as indicated by creatinine clearance \\< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\< 45 mL/min/1.73m2.\n* Presence of active severe bacterial or viral infections or other severe concurrent disease/infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV). For HBV serology, the determination of HBsAg and anti-HBcAg Ab is required. In patients with serology documenting previous exposure to HBV, negative serum HBV-DNA is required. For HCV, HCV-RNA or HCV antibody test is required. Subjects with a positive test for HCV antibody but no detection of HCV-RNA indicating no current infection are eligible.\n* History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).\n* Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.\n* Known arterial aneurysms.\n* INR \\> 3.\n* Uncontrolled hypertension.\n* Known uncontrolled coagulopathy or bleeding disorder.\n* Known hepatic cirrhosis or severe pre-existing hepatic impairment.\n* Moderate to severe respiratory failure.\n* Active autoimmune disease that has required systemic treatment in past 2 years.\n* Patients have a diagnosis of immunodeficiency or are receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.\n* Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.\n* Pregnancy or breast-feeding.\n* Ischemic peripheral vascular disease (Grade IIb-IV).\n* Severe diabetic retinopathy.\n* Recovery from major trauma including surgery within 4 weeks prior to enrollment.\n* Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.\n* Patients with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Patients who have received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.\n* Any conditions that in the opinion of the investigator could hamper compliance with the study protocol.","locations":[{"facility":"H. Lee Moffitt Cancer Center and Research Institute Hospital, Inc.","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winship Cancer Institute, Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Wexner Medical Center Clinical Laboratories","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Augsburg","city":"Augsburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite Universitaetsmedizin Berlin KöR","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Essen AöR","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Halle (Saale) AöR","city":"Halle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Schleswig-Holstein AöR","city":"Kiel","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Tuebingen AöR","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Andreas Syngros Hospital Of Venereal And Dermatological Diseases","city":"Athens","state":"","country":"Greece","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Nazionale Tumori Fondazione Pascale","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Humanitas Mirasole S.p.A.","city":"Rozzano","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero-Universitaria Senese","city":"Siena","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic De Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Nadal","phone":"05771526723","email":"lisa.nadal@philogen.com"},{"name":"Concetta Aulicino","phone":"+39057717816","email":"regulatory@philogen.com"}],"primaryOutcomes":["Best Overall Response Rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["tampa-florida","atlanta-georgia","durham-north-carolina","cleveland-ohio","columbus-ohio","houston-texas","augsburg-germany","berlin-germany","essen-germany","halle-germany","kiel-germany","t-bingen-germany","athens-greece","naples-italy","roma-italy","rozzano-italy","siena-italy","barcelona-spain"],"enrichment":{"headline":"Phase 2: testing L19IL2 for Locally Advanced Basal Cell Carcinoma","inPlainEnglish":"Open label, randomly assigned study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board. The primary objective of the study is to measure the how well it works of L19IL2 or L19TNF or L19IL2/L19TNF, the secondary objectives of this study are to evaluate how well it works, safety and pharmacokinetics of immunocytokines.","whoItsFor":["Ages 18 Years to any","Patients with at least one injectable and measurable cutaneous or subcutaneous lesion","Patients must not have received prior HHIs and checkpoint inhibitors systemic treatment","Patients may have received prior surgery and/or radiation therapy","BCC that has recurred in the same location after two or more surgical procedures and curative resection is deemed unlikely;","Anticipated substantial morbidity and/or deformity from surgery (e.g., removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation);","Medical conditions predisposing to poor surgical outcome (e.g., diabetes with history of poor wound healing);","Other conditions considered to be medically contraindicating must be discussed with the Medical Monitor before enrolling the patient"],"whoShouldSkip":["Current topical or systemic chemotherapy, targeted therapy immunotherapy","Patients with node positive BCC who are candidates for checkpoint inhibitor therapy","Chronically impaired renal function as indicated by creatinine clearance \\< 60 mL/min/1.73m2 or for patients older than 65 years without albuminuria or proteinuria, creatinine clearance \\< 45 mL/min/1.73m2","History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria)","Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator","Known arterial aneurysms","Uncontrolled hypertension"],"whatHappens":"If you join, the listed intervention(s) are L19IL2, L19TNF, or L19IL2/L19TNF. The registry lists allocation as randomized. Open label, randomly assigned study in patients with LaBCC not eligible or refusing surgery or radiation therapy according to the evaluation of a local interdisciplinary tumor board.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.494Z"},{"nctId":"NCT07227363","title":"Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot","officialTitle":"Symptoms of Polycystic Ovarian Syndrome Ameliorated by Keto-Adaptation Pilot","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ohio State University","sponsorClass":"OTHER","summary":"The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS).\n\nParticipants will be randomly assigned to one of two groups:\n\n* A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.\n* A mixed diet plus ketone supplement group, following general dietary guidelines while taking an exogenous ketone supplement.\n\nThe study will measure whether these approaches help restore regular ovulation and improve hormone balance, metabolism, and overall well-being. Optional imaging using MRI will also examine heart and ovarian health.\n\nThis pilot study will help researchers understand if ketogenic nutrition strategies are a safe, effective way to support menstrual regularity and reduce PCOS-related symptoms, providing groundwork for larger clinical trials.","conditions":["PCOS (Polycystic Ovary Syndrome)"],"keywords":["Ketogenic Diet","Exogenous Ketones","Nutritional Ketosis","Reproductive Hormones","Ovarian Function","Women's Health","Metabolic Health","PCOS"],"interventions":[{"type":"OTHER","name":"Ketogenic diet"},{"type":"DIETARY_SUPPLEMENT","name":"Exogenous Ketone Supplement"}],"enrollment":40,"startDate":"2026-12-01","completionDate":"2026-12","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female participants aged 18-40 years.\n* Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound).\n* Willingness and ability to comply with all study procedures, including fasting (\\>10 hours; water only), avoidance of alcohol (\\>24 hours), and abstaining from exercise (\\>24 hours) prior to each test visit.\n* Willing to maintain current diet, exercise, medication, and supplement habits throughout the study.\n* Body mass index (BMI) ≥18 kg/m².\n* Access to a smartphone, computer, or tablet for digital tracking and study communication.\n\nExclusion Criteria:\n\n* Current adherence to a low-carbohydrate diet (\\<30% of total energy from carbohydrates).\n* Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders).\n* History of type 1 diabetes or uncontrolled type 2 diabetes.\n* Weight loss ≥10% of body weight within the previous 6 months.\n* Pregnancy or breastfeeding.\n* Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment.\n* Active eating disorder or medical condition that could interfere with dietary intervention.\n* Any condition that, in the opinion of the Investigator, could interfere with participation, data integrity, or safety.","locations":[{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Madison Kackley, PhD","phone":"16142479650","email":"Kackley.19@osu.edu"}],"primaryOutcomes":["Change in Ovulatory Status"],"hasResults":false,"conditionSlugs":["als","pcos"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Ketogenic diet for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS). you would be randomly assigned to one of two groups: * A ketogenic diet group, following a low-carbohydrate, nutrient-dense meal plan.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Female participants aged 18-40 years","Clinical diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria (presence of at least two of the following: oligo- or anovulation, clinical or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound)","Willingness and ability to comply with all study procedures, including fasting (\\>10 hours; water only), avoidance of alcohol (\\>24 hours), and abstaining from exercise (\\>24 hours) prior to each test visit","Willing to maintain current diet, exercise, medication, and supplement habits throughout the study","Body mass index (body-mass index (BMI)) ≥18 kg/m²","Access to a smartphone, computer, or tablet for digital tracking and study communication"],"whoShouldSkip":["Current adherence to a low-carbohydrate diet (\\<30% of total energy from carbohydrates)","Non-PCOS etiologies of anovulation (e.g., menopause, oophorectomy, or other reproductive disorders)","History of type 1 diabetes or uncontrolled type 2 diabetes","Weight loss ≥10% of body weight within the previous 6 months","Pregnancy or breastfeeding","Use of hormonal contraception or medications known to alter reproductive hormones within 3 months prior to enrollment","Active eating disorder or medical condition that could interfere with dietary intervention"],"whatHappens":"If you join, the listed intervention(s) are Ketogenic diet, or Exogenous Ketone Supplement. The registry lists allocation as randomized. The SPARK- Pilot study (Symptoms of PCOS Ameliorated by Responses to Keto-adaptation) is a 12-week clinical trial at The Ohio State University designed to explore how different ways of achieving ketosis may improve reproductive and metabolic health in women with Polycystic Ovary Syndrome (PCOS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Columbus. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.799Z"},{"nctId":"NCT07227454","title":"A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder","officialTitle":"A Double-blind, Randomized, Psychoactive Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine 84 mg in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder in Adolescent Participants With Acute Suicidal Ideation or Behavior","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well JNJ-54135419 works (efficacy) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (MDD, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive placebo (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.","conditions":["Depressive Disorder, Major"],"keywords":[],"interventions":[{"type":"DRUG","name":"Esketamine"},{"type":"DRUG","name":"Midazolam"},{"type":"OTHER","name":"Oral Placebo"},{"type":"OTHER","name":"Intranasal Placebo"}],"enrollment":258,"startDate":"2026-01-08","completionDate":"2031-04-09","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (MDD) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)\n* Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of \"Markedly\" or greater (that is, greater than or equal to \\[\\>=\\] 4) at both screening and baseline (predose) visits\n* Must have a children's depression rating scale - revised (CDRS-R) total score \\>= 58 at baseline (predose)\n* In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality\n* Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening\n\nExclusion Criteria:\n\n* Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder\n* Participant currently meets DSM-5 criteria for borderline personality disorder\n* Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or MDD with psychosis\n* Participant has a history of seizure disorder\n* Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Child Study Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's National Medical Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peachford Hospital-Atlanta Behavioral Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health Evanston Hospital","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Childrens Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradley Hospital","city":"East Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John S Dunn Behavioral Sciences Center at UTHealth Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sociedade Literaria e Caritativa Santo Agostinho Hospital Sao Jose","city":"Criciúma","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universidade Federal do Rio Grande do Norte Hospital Universitario Onofre Lopes","city":"Natal","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Apice","city":"Salvador","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Integrado Facili","city":"São Bernardo do Campo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Pesquisa Pensi Sandra Mutarelli Setubal","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Das Clinicas Da Faculdade De Medicina Da USP","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vadaskert Gyermek es Ifjusagpszichiatriai Korhaz es Szakambulancia","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Debreceni Egyetem Klinikai Kozpont","city":"Debrecen","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Petz Aladar Megyei Oktato Korhaz","city":"Győr","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szegedi Tudomanyegyetem","city":"Szeged","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Presidio Ospedaliero Santa Marta e Santa Venera","city":"Acireale","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera G. Brotzu","city":"Cagliari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AOU Meyer","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Riuniti di Foggia","city":"Foggia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"G.Gaslini Institute","city":"Genova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale di Merano","city":"Merano","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Federico II","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria di Sassari","city":"Sassari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic de Psihiatrie Prof Dr Alexandru Obregia","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic de Urgenta pentru Copii Cluj Napoca","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic De Psihiatrie Doctor Gheorghe Preda","city":"Sibiu","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic de Urgenta pentru Copii 'Louis Turcanu' Timisoara","city":"Timișoara","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp Univ Vall D Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Sant Joan de Deu","city":"Esplugues de Llobregat","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Gral. Univ. Gregorio Maranon","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacio Althaia Xarxa Assistencial Universitaria de Manresa","city":"Manresa","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. Central de Asturias","city":"Oviedo","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Univ. de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp.Univ.Parc Tauli","city":"Sabadell","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hosp. Univ. Marques de Valdecilla","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mackay Memorial Hospital Tamsui Branch","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Medical University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tri-Service General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Change from Baseline in Depressive Symptoms Measured by Children's Depression Rating Scale - Revised (CDRS-R) Total Score at 24 Hours Post First Dose"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["birmingham-alabama","new-haven-connecticut","washington-d-c-district-of-columbia","atlanta-georgia","evanston-illinois","baltimore-maryland","boston-massachusetts","rochester-minnesota","chapel-hill-north-carolina","cincinnati-ohio","east-providence-rhode-island","houston-texas","crici-ma-brazil","natal-brazil","salvador-brazil","s-o-bernardo-do-campo-brazil","s-o-paulo-brazil","budapest-hungary","debrecen-hungary","gy-r-hungary","szeged-hungary","acireale-italy","cagliari-italy","florence-italy","foggia-italy","genova-italy","merano-italy","naples-italy","sassari-italy","bucharest-romania","cluj-napoca-romania","sibiu-romania","timi-oara-romania","barcelona-spain","esplugues-de-llobregat-spain","madrid-spain","manresa-spain","oviedo-spain","pamplona-spain","sabadell-spain","santander-spain","new-taipei-city-taiwan","taipei-taiwan"],"enrichment":{"headline":"Phase 3: testing Esketamine for Depressive Disorder, Major","inPlainEnglish":"This study wants to evaluate how well JNJ-54135419 works (how well it works) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (major depression, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive dummy treatment (placebo) (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.","whoItsFor":["Ages 12 Years to 17 Years","Must meet diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for major depressive disorder (major depression) based upon clinical assessment and confirmed by the mini-international neuropsychiatric interview for children and adolescents (MINI-KID)","Must have a clinical global impression - severity of suicidality - revised (CGI-SS-R) score of \"Markedly\" or greater (that is, greater than or equal to \\[\\>=\\] 4) at both screening and baseline (predose) visits","Must have a children's depression rating scale - revised (CDRS-R) total score \\>= 58 at baseline (predose)","In the physician's opinion, acute psychiatric hospitalization is clinically warranted due to subject's acute suicidality","Must be medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening"],"whoShouldSkip":["Participant has a current DSM-5 diagnosis of bipolar (or related disorders), intellectual disability, autism spectrum disorder, conduct disorder, oppositional defiant disorder","Participant currently meets DSM-5 criteria for borderline personality disorder","Participant has a current or prior DSM-5 diagnosis of a psychotic disorder, or major depression with psychosis","Participant has a history of seizure disorder","Participant has known allergies, hypersensitivity, intolerance or contraindications to midazolam, esketamine or ketamine, or their excipients"],"whatHappens":"If you join, the listed intervention(s) are Esketamine, Midazolam, or Oral Placebo. The registry lists allocation as randomized. This study wants to evaluate how well JNJ-54135419 works (how well it works) in addition to comprehensive standard of care (SoC) in rapidly reducing the symptoms of major depressive disorder (major depression, a mental disorder characterized by a persistent feeling of sadness and loss of interest in activities) as compared with psychoactive dummy treatment (placebo) (does not contain JNJ-54135419) plus SoC in adolescent participants with acute suicidal ideation or behavior.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 258 people at 49 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.121Z"},{"nctId":"NCT07227532","title":"A Study Assessing Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With VARIPULSE Catheter System","officialTitle":"BWI202405: Assessment of Long-Term Safety and Effectiveness in Treatment Management of Atrial Fibrillation With the VARIPULSE™ Catheter System","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Biosense Webster, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator"}],"enrollment":276,"startDate":"2025-10-21","completionDate":"2030-12-31","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF\n* Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post-, and follow-up testing and requirements\n\nExclusion Criteria:\n\n* Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)\n* Previous surgical or catheter ablation for AF\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF\n* Current enrollment in an investigational study evaluating another device or drug\n* Life expectancy less than 12 months\n* Any contraindications as defined in the Protocol","locations":[{"facility":"Phoenix Cardiovascular Research Group","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tucson Medical Center Pima Heart and Vascular","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OC Memorial","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Memorial Hospital","city":"Ventura","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Denver Cardiology Associates","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Florida Mercy Hospital","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Heart and Vascular Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edward Hospital Midwest Cardiovascular Institute","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Kansas City Heart Rhythm Institute","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health System","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health","city":"Ypsilanti","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Capital Health Regional Medical Center","city":"Trenton","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health Physician Partners Cardiology","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albert Einstein College Of Medicine - Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Medical Center","city":"Springfield","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Cardiac Arrhythmia Research Foundation","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Scott and White Research Institute","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winchester Medical Center","city":"Winchester","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital","city":"Janesville","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily Purcell","phone":"+1 949 230 3701","email":"EPurcel1@its.jnj.com"}],"primaryOutcomes":["Occurences of Early Onset Primary Adverse Events (PAEs) Within 7 days of the Index Ablation Procedure","Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episodes"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","tucson-arizona","fountain-valley-california","ventura-california","aurora-colorado","jacksonville-florida","miami-florida","orlando-florida","naperville-illinois","iowa-city-iowa","kansas-city-kansas","overland-park-kansas","detroit-michigan","ypsilanti-michigan","rochester-minnesota","trenton-new-jersey","lake-success-new-york","the-bronx-new-york","cincinnati-ohio","springfield-ohio","austin-texas","fort-worth-texas","plano-texas","winchester-virginia","janesville-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator for Atrial Fibrillation","inPlainEnglish":"This study wants to measure the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).","whoItsFor":["Ages 22 Years to any","Symptomatic paroxysmal Atrial Fibrillation (AF) who, in the opinion of the investigator, are candidates for catheter ablation for AF","Refractory (that is, ineffective, not tolerated, or not desired) or contraindicated to at least one Class I/III antiarrhythmic drugs (AAD)","Willing and capable of providing consent"],"whoShouldSkip":["Previously diagnosed with persistent or long-standing persistent AF (more than \\[\\>\\] 7 days in duration)","Previous surgical or catheter ablation for AF","Significant congenital anomaly or medical problem that in the opinion of the investigator would be a contraindication to catheter ablation for AF","Current enrollment in an investigational study evaluating another device or drug","Life expectancy less than 12 months","Any contraindications as defined in the Protocol"],"whatHappens":"If you join, the listed intervention(s) are Pulsed Field Ablation by VARIPULSE Catheter with TRUPULSE Generator. The registry lists allocation as na. This study wants to measure the long-term safety and effectiveness of the FDA approved VARIPULSE catheter system for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 276 people at 25 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.741Z"},{"nctId":"NCT07227896","title":"Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earlier Within Advanced Parkinson Disease","officialTitle":"A Global Real-World Evidence Study on the Effectiveness and Safety/Tolerability of Foslevodopa/Foscarbidopa in Patients Earlier Within Advanced Parkinson's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study will assess how effective Foslevodopa/Foscarbidopa is in treating adult participants earlier within advanced Parkinson disease under routine clinical practice.\n\nFoslevodopa/Foscarbidopa is an approved drug for the treatment of Parkinson's Disease. Approximately 100 adult participants who are prescribed Foslevodopa/Foscarbidopa by their doctors will be enrolled across approximately 40 sites across the world.\n\nParticipants will receive Foslevodopa/Foscarbidopa subcutaneous infusion as prescribed by their physician. Participants will be followed for up to 6 months.\n\nThere are no additional examinations due to the study but the participants and caregivers will need to fill several questionnaires to generate data on their motor function and well-being","conditions":["Parkinson's Disease"],"keywords":["Parkinson's Disease","Foslevodopa/Foscarbidopa"],"interventions":[],"enrollment":100,"startDate":"2026-08-03","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"69 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable\n* A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)\n* Adult male or female between 18 and 69 years of age\n* Disease duration (time since diagnosis) \\<10 years\n* Time since motor fluctuations started ≤5 years\n* H\\&Y Stage \\<3 in best \"on\"\n* \"off\" time of ≤ 4.5 hours per day\n* Naïve to LDp/CDp\n* Treatment has been optimized with oral/transdermal PD medication in the opinion of the Investigator\n* Decision to treat with LDp/CDp made by the clinician prior to any decision to approach the participant to participate in the study\n* Willing and able to comply with procedures required during this study, specifically with entering data and filling questionnaires in an electronic device (tablet).\n* Prior to any study-related procedures being performed, the participant or Legal Authorized Representative (LAR) must voluntarily sign an Authorization for Use/Disclosure of Data (AUDD)/Informed Consent Form (ICF) according to national regulations once the study has been explained and the participant has the opportunity to have any questions answered\n\nExclusion Criteria:\n\n* History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country\n* History of treatment with any Device-Aided Therapy (DAT), such as Deep Brain Stimulation (DBS), Continuous Subcutaneous Apomorphine Infusion (CSAI), Levodopa/Carbidopa Intestinal Gel (LCIG)/ Carbidopa/Levodopa Enteral Suspension (CLES), Levodopa/Entacapone/Carbidopa Intestinal Gel (LECIG)\n* Mini-Mental State Examination (MMSE) score \\<24\n* Participation in a concurrent investigational or observational clinical trial\n* Lack of motivation/insufficient language skills to complete the study questionnaires\n* History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis). In case of temporary affections like recent sunburn or open wounds, or in case of permanent affections like acne, scar tissue, tattoo, branding, or colorations, the participant should not be included if the Investigator considers these as interfering with infusion of study drug or study assessments.","locations":[{"facility":"Parkinson'S Disease & Movement Disorders Center Of Boca Raton /ID# 277190","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida- Neuroscience Institute /ID# 278562","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novant Health /ID# 278567","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Movement Disorder Specialists /ID# 278565","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto Western Hospital /ID# 278384","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIUSSS de l Estrie - CHUS /ID# 278379","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinicka Bolnica Dubrava /ID# 278408","city":"Grad Zagreb","state":"City of Zagreb","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinicki Bolnicki Centar Rijeka /ID# 278277","city":"Rijeka","state":"Primorje-Gorski Kotar County","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center /ID# 276209","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Chaim Sheba Medical Center /ID# 276210","city":"Ramat Gan","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center /ID# 276212","city":"Tel Aviv","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center-Hebrew University /ID# 276211","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Medical University Hospital /ID# 280624","city":"Iruma-gun","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital /ID# 280623","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Noge General Medicine and Neurology /ID# 280741","city":"Kanagawa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Itsuki Hospital /ID# 280743","city":"Tokushima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miwa Internal Medicine Clinic /ID# 280740","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Internacional De Mercadeo /ID# 276088","city":"Guaynabo","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundeni Clinical Institute /ID# 277490","city":"Bucharest","state":"Bucharest","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcadia Spitale Si Centre Medicale /Id# 277525","city":"Iași","state":"Iaşi","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurotim Med /ID# 277500","city":"Timișoara","state":"Timiș County","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean De Urgenta Brasov /ID# 277499","city":"Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Sant Joan Despi Moises Broggi /ID# 276895","city":"Sant Joan Despí","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Plymouth NHS Trust /ID# 284977","city":"Plymouth","state":"Devon","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charing Cross Hospital /ID# 284211","city":"London","state":"Hammersmith and Fulham","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 281752","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lars Bergmann","phone":"+49(0)170 4538568","email":"lars.bergmann@abbvie.com"}],"primaryOutcomes":["Change From Baseline in motor complications as measured by modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV subscore"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["boca-raton-florida","tampa-florida","charlotte-north-carolina","georgetown-texas","toronto-canada","sherbrooke-canada","grad-zagreb-croatia","rijeka-croatia","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","iruma-gun-japan","bunkyo-ku-japan","kanagawa-japan","tokushima-japan","tokyo-japan","guaynabo-puerto-rico","bucharest-romania","ia-i-romania","timi-oara-romania","brasov-romania","sant-joan-desp-spain","plymouth-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom"],"enrichment":{"headline":"Real-World Study of Foslevodopa/Foscarbidopa to Assess Quality of Life Outcomes in Adult Participants Earli…","inPlainEnglish":"Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person.","whoItsFor":["Ages 18 Years to 69 Years","Eligibility for Foslevodopa/Foscarbidopa (LDp/CDp) therapy in accordance with approved local label in the participating country and local reimbursement regulations, if applicable","A diagnosis of levodopa-responsive idiopathic Parkinson's Disease (PD)","Adult male or female between 18 and 69 years of age","Disease duration (time since diagnosis) \\<10 years","Time since motor fluctuations started ≤5 years","H\\&Y Stage \\<3 in best \"on\"","\"off\" time of ≤ 4.5 hours per day"],"whoShouldSkip":["History of any condition included in the contraindications section of the approved local Foslevodopa/Foscarbidopa (LDp/CDp) label in the participating country","Mini-Mental State Examination (MMSE) score \\<24","Participation in a concurrent investigational or watch-and-measure (no experimental treatment required) clinical trial","Lack of motivation/insufficient language skills to complete the study questionnaires"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 26 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.660Z"},{"nctId":"NCT07228832","title":"Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer","officialTitle":"A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Summit Therapeutics","sponsorClass":"INDUSTRY","summary":"A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)","conditions":["Metastatic Colorectal Cancer (CRC)"],"keywords":["mCRC","Ivonescimab"],"interventions":[{"type":"DRUG","name":"Drug: Ivonescimab Injection"},{"type":"DRUG","name":"Drug: Bevacizumab Injection"}],"enrollment":900,"startDate":"2025-11-18","completionDate":"2028-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. ECOG performance status score of 0 or 1\n2. Expected life expectancy ≥ 6 months\n3. Patients with histologically or cytologically confirmed metastatic CRC\n4. No prior systemic therapy for metastatic CRC\n5. At least 1 measurable noncerebral lesion\n\nExclusion Criteria:\n\n1. Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease\n2. Known BRAF V600E mutant status\n3. Current presence of significant radiographic or clinical manifestations of gastrointestinal (GI) obstruction\n4. Ascites requiring paracentesis within last 30 days\n5. Patients who have received prior immunotherapy or anti-angiogenic therapy for colorectal cancer\n6. Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)\n7. Resectable disease","locations":[{"facility":"Clinical Study Site","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Tuscaloosa","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Goodyear","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Cerritos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Corona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Roseville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Santa Clara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Stanford","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Upland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Vallejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"West Hollywood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Highlands Ranch","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Study Site","city":"Lone 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The registry lists allocation as randomized. A randomly assigned, Active-Controlled, neither you nor the study doctors know who gets the real treatment, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 900 people at 211 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.086Z"},{"nctId":"NCT07232030","title":"Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure","officialTitle":"Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure (BENEFIT-HF)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"CVRx, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \\< 50% and NT-proBNP \\< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).","conditions":["Heart Failure","Heart Failure NYHA Class II","Heart Failure NYHA Class III"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Barostim System"},{"type":"OTHER","name":"Usual care medical management"}],"enrollment":2500,"startDate":"2026-04-24","completionDate":"2033-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years or above\n2. NYHA Functional Class II or III heart failure symptoms at the time of screening\n3. Left ventricular ejection fraction \\< 50% within 6 months of consent\n4. Heart failure accompanied by either:\n\n   * Screening local lab NT-proBNP ≥ 400 AND \\< 5,000 pg/mL or a BNP ≥100 AND \\< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting OR\n   * A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \\< 5,000 pg/mL or BNP \\< 1,250 pg/mL, adjusted for BMI in a stable outpatient setting.\n\n   Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for BMI using a 4% reduction per BMI unit over 25 kg/m2.\n5. On optimal, maximally tolerated Guideline Directed Medical Therapy (GDMT) (medications and devices) per current country specific guidelines (e.g. US follows AHA/ACC guidelines, Germany follows DGK/ESC guidelines) for the treatment of heart failure, when appropriate, throughout screening/baseline evaluation and for at least 4 weeks prior to consent:\n\n   * No more than a 100% increase or a 50% decrease of the dosage of any one medication other than an oral diuretic.\n   * Medication changes within a drug class are allowed as long as the equivalent dosage is within the limits specified above.\n   * Unrestricted changes in oral diuretics are allowed.\n   * For participants with LVEF between 40-50%, SGLT2 inhibitors and mineralocorticoid receptor antagonists (MRAs) are encouraged and should be initiated before consent when possible.\n6. Six-minute hall walk (6MHW) ≥ 100 m AND ≤ 450 m within 15 days after consent.\n7. If female and of childbearing potential, must have a negative pregnancy test within 15 days after consent.\n8. Be an appropriate candidate for the trial and the surgical procedure as determined by the investigator or designee and the surgeon.\n9. Have signed an informed consent form for participation in this trial.\n\nExclusion Criteria:\n\n1. Any contraindications to Barostim as noted in Instructions for Use.\n2. An existing device which contraindicates Barostim specifically or unipolar therapy in general.\n3. Advanced heart failure defined by any of the following:\n\n   * AHA/ACC Stage D heart failure.\n   * Two or more NT-proBNP results \\>5,000 pg/mL or BNP \\>1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility.\n   * Current or prior continuous or intermittent intravenous positive inotrope therapy.\n   * Has received, is receiving, or scheduled to receive LVAD therapy.\n   * Solid organ or hematologic transplant or currently being evaluated for cardiac transplant.\n4. Serum estimated glomerular filtration rate (eGFR) \\< 20 mL/min/1.73 m2 or has end-stage renal disease.\n5. Recurring symptomatic hypotension.\n6. Life expectancy less than one year.\n7. An inappropriate trial candidate as evidenced by at least one of the following:\n\n   * Has received or is receiving chronic dialysis.\n   * Is within WHO groups 1, 3, 4, or 5 pulmonary hypertension.\n   * Severe COPD or severe restrictive lung disease requiring chronic oral steroid use or any oxygen use.\n   * Heart failure secondary to a reversible cause, such as cardiac structural valvular disease, acute myocarditis and pericardial constriction.\n   * Active malignancy with the exception of non-melanoma skin cancers.\n   * Infiltrative cardiomyopathy (e.g. cardiac amyloidosis).\n   * Any other serious medical condition that may adversely affect the safety of the participant or validity of the trial, in the opinion of the investigator.\n8. Any of the following within 3 months prior to consent:\n\n   * Myocardial infarction\n   * Unstable angina\n   * Percutaneous coronary intervention (e.g. PTCA)\n   * Cerebral vascular accident or transient ischemic attack\n   * Cardiac arrest\n   * Surgical cardiac intervention (e.g., CABG, cardiac ablation, valve replacement, CRT/ICD implantation, IPG battery replacements)\n9. Surgery planned to occur within 45 days of the Barostim implant procedure. This includes pacemaker or ICD implants or battery replacements.\n10. Enrolled and active in another clinical trial (e.g. device, pharmaceutical, or biological) unless approved by the CVRx Clinical Research department.\n11. Unable or unwilling to fulfill the Protocol medication compliance and follow-up requirements, for reasons including but not limited to an unresolved history of alcohol or substance abuse or psychiatric disorder. Participant is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those permanently incapable of giving informed consent. Vulnerable populations also include university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.","locations":[{"facility":"Cardiology Associates of Mobile","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PIH Health Good Samaritan Hospital","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck School of Medicine of USC","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BayCare Health System","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Coast Cardiovascular Institute","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tallahassee Research Institute","city":"Tallahassee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BayCare Health Systems","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Alexian Brothers","city":"Elk Grove Village","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiovascular Medicine","city":"Moline","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension St. Vincent","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Luke's Hospital of Kansas City","city":"Kansas City","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center/NewYork Presbyterian Hospital","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Francis Hospital","city":"Tulsa","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"North Central Heart","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erlanger Health","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stern Cardiovascular Center","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRISTUS Trinity Mother Frances","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinic Research Institute","city":"Marshfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christina Dierkhising","phone":"+1 763-416-2870","email":"cdierkhising@cvrx.com"}],"primaryOutcomes":["Primary Effectiveness Endpoint","Primary Safety Endpoint"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["mobile-alabama","los-angeles-california","clearwater-florida","jacksonville-florida","orlando-florida","tallahassee-florida","tampa-florida","elk-grove-village-illinois","moline-illinois","indianapolis-indiana","boston-massachusetts","kansas-city-missouri","omaha-nebraska","new-york-new-york","cincinnati-ohio","tulsa-oklahoma","sioux-falls-south-dakota","chattanooga-tennessee","germantown-tennessee","tyler-texas","marshfield-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Barostim System for Heart Failure","inPlainEnglish":"The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \\< 50% and NT-proBNP \\< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices). It includes demonstration that treatment with the Barostim System, relative to usual care medical management, reduces the rate of all-cause mortality and Heart Failure Morbidity (Cardiac Transplant, Durable LVAD, or Worsening Heart Failure Events).","whoItsFor":["Ages 18 Years to any","Age 18 years or above","NYHA Functional Class II or III heart failure symptoms at the time of screening","Left ventricular ejection fraction \\< 50% within 6 months of consent","Heart failure accompanied by either:","Screening local lab NT-proBNP ≥ 400 AND \\< 5,000 pg/mL or a BNP ≥100 AND \\< 1,250 pg/mL, adjusted for body-mass index (BMI) in a stable outpatient setting OR","A documented Worsening Heart Failure Event in the 6 months prior to or concurrent with consent, AND an NT-proBNP \\< 5,000 pg/mL or BNP \\< 1,250 pg/mL, adjusted for body-mass index (BMI) in a stable outpatient setting","Note: If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility. NT-proBNP and BNP to be adjusted for body-mass index (BMI) using a 4% reduction per body-mass index (BMI) unit over 25 kg/m2"],"whoShouldSkip":["Any contraindications to Barostim as noted in Instructions for Use","An existing device which contraindicates Barostim specifically or unipolar therapy in general","Advanced heart failure defined by any of the following:","AHA/ACC Stage D heart failure","Two or more NT-proBNP results \\>5,000 pg/mL or BNP \\>1,250 pg/mL in a stable outpatient setting within 3 months prior to consent. If participant is taking sacubitril/valsartan (i.e. Entresto®), NT-proBNP must be used for screening eligibility","Current or prior continuous or intermittent intravenous positive inotrope therapy","Has received, is receiving, or scheduled to receive LVAD therapy"],"whatHappens":"If you join, the listed intervention(s) are Barostim System, or Usual care medical management. The registry lists allocation as randomized. The purpose of BENEFIT-HF is to demonstrate the safety and effectiveness of Baroreflex Activation Therapy (BAT) with the Barostim System in participants with heart failure, defined as NYHA Functional Class II or III, LVEF \\< 50% and NT-proBNP \\< 5,000 pg/mL despite being treated with Guideline-Directed Medical Therapies (medications and devices).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 2,500 people at 23 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.427Z"},{"nctId":"NCT07232069","title":"PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","officialTitle":"Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"QUADRUPLE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.\n\nPRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called \"plaque\", in their heart arteries. It consists of two phases:\n\n1. A Screening Study - Participants will be assessed for plaque by one or both of these scans.\n\n   * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries.\n   * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque.\n2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos.\n\n   * Rosuvastatin 20 mg: a cholesterol-lowering medicine\n   * Colchicine 0.5 mg: a medication that lowers inflammation\n\nEveryone in the trial will be given information and advice on heart-healthy diet and lifestyle.\n\nParticipants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.","conditions":["Coronary Artery Disease Risk Factors Multiple","Coronary Artery Disease Progression","Prevention & Control","Premature Atherosclerosis"],"keywords":["Prevention","Heart Disease Prevention","Family History of Heart Disease","At risk for heart disease","coronary artery calcium","non-calcified coronary plaque"],"interventions":[{"type":"DRUG","name":"Rosuvastatin 20 Mg Oral Tablet"},{"type":"DRUG","name":"Colchicine 0.5 MG Oral Tablet Once Daily"},{"type":"DRUG","name":"Placebo"}],"enrollment":1500,"startDate":"2026-07-21","completionDate":"2031-07","sex":"ALL","minAge":"30 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Women aged 40-60 years; Men aged 30-50 years\n2. Willing and able to provide informed consent and comply with study procedures\n3. Smart phone user\n4. Use of highly effective contraception by females with reproductive potential.\n5. CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\\<100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)\n6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab\n\nExclusion Criteria:\n\n1. Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)\n2. Current symptoms thought to be from CAD\n3. PREVENT ASCVD 10-year risk ≥5% (if known)\n4. Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)\n5. LDL-C ≥190mg/dL (most recent, if known)\n6. HIV (if known)\n7. Severe liver disease or untreated Hepatitis C infection (if known)\n8. Pregnancy, lactation or intending to become pregnant during the study period of 2 years\n9. eGFR \\<45mL/min/1.73m2 (if known)\n10. AST or ALT \\>1.5x the upper limit of normal (if known)\n11. BMI\\>40kg/m2 or unable to have a CCTA scan for any reason\n12. Allergy to iodinated intravenous contrast or other contraindication to CCTA\n13. Current or previous use of lipid lowering therapy or colchicine\n14. Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.\n15. Systemic cancer undergoing active treatment\n16. PREVENT ASCVD 10-year risk ≥5%\n17. eGFR \\<45 ml/min/1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)\n18. Hemoglobin A1c ≥6.5% per baseline labs\n19. LDL-C ≥190mg/dL per baseline labs\n20. Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)\n21. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)\n22. Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiology Associates","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wellstar Kennestone Hospital","city":"Hiram","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital Brigham","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essentia Health","city":"Duluth","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern Westchester Hospital","city":"Mount Kisco","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"New York University Langone","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Hospital","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University, Advocate Health","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Sciences University","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina (MUSC)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia (UVA)","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Health System","city":"Fairfax","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Marshfield Clinical Research Institute","city":"Marshfield","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rachel Olson, Project Manager","phone":"919-309-5544","email":"rachel.e.olson@duke.edu"}],"primaryOutcomes":["Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","mobile-alabama","los-angeles-california","hiram-georgia","chicago-illinois","baltimore-maryland","boston-massachusetts","duluth-minnesota","mount-kisco-new-york","new-york-new-york","durham-north-carolina","winston-salem-north-carolina","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","charleston-south-carolina","nashville-tennessee","houston-texas","charlottesville-virginia","fairfax-virginia","marshfield-wisconsin"],"enrichment":{"headline":"Phase 3: testing Rosuvastatin 20 Mg Oral Tablet for Coronary Artery Disease Risk Factors Multiple","inPlainEnglish":"Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.","whoItsFor":["Ages 30 Years to 60 Years","Women aged 40-60 years; Men aged 30-50 years","Use of highly effective contraception by females with reproductive potential","CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\\<100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)","Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab"],"whoShouldSkip":["Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)","Current symptoms thought to be from CAD","PREVENT ASCVD 10-year risk ≥5% (if known)","Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)","LDL-C ≥190mg/dL (most recent, if known)","Severe liver disease or untreated Hepatitis C infection (if known)","Pregnancy, lactation or intending to become pregnant during the study period of 2 years"],"whatHappens":"If you join, the listed intervention(s) are Rosuvastatin 20 Mg Oral Tablet, Colchicine 0.5 MG Oral Tablet Once Daily, or Placebo. The registry lists allocation as randomized. Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,500 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.067Z"},{"nctId":"NCT07232485","title":"Retinal Imaging for Systemic Inflammation in Endometriosis","officialTitle":"Retinal Imaging for the Assessment of Systemic Inflammation in Endometriosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Edinburgh","sponsorClass":"OTHER","summary":"There is increasing evidence that examining our eyes can tell us a lot of information about our health, and systemic diseases. Our plan is to compare the images taken of the back of eyes of women who have endometriosis with those of women who don't. We want to study what eyes can reveal about endometriosis by analyzing the retinal images from a simple noninvasive eye scan, that is already being routinely used to provide immediate clinical information in other groups of patients (eg. diabetic eye screening).","conditions":["Endometriosis"],"keywords":["Endometriosis","Retinal imaging","Systemic inflammation"],"interventions":[],"enrollment":100,"startDate":"2025-09-03","completionDate":"2029-08","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants with a previous surgical or imaging diagnosis of endometriosis\n\n   * Pre-menopausal women and those assigned female at birth\n   * Aged 18 years and over\n   * A past surgical or imaging diagnosis of endometriosis within the last 5 years from date of consent\n   * Ability to understand and willingness to sign the informed consent form\n2. Healthy volunteers\n\n   * Women and those assigned female at birth\n   * Aged 18 years and over\n   * No history of endometriosis or chronic pelvic pain\n   * Ability to understand and willingness to sign the informed consent form\n\nExclusion Criteria:\n\n1. Participants with a previous surgical or imaging diagnosis of endometriosis\n\n   * The subject has donated blood (450 ml) within the last 4 weeks\n   * Known reproductive tract malignancy\n   * Ocular Diseases:\n\n     * Subjects with clinically diagnosed glaucoma, optic neuropathy, optic neuritis, cataracts, or other conditions that affect the ocular structures.\n     * Subjects with age-related macular degeneration, retinal vascular diseases, or other retinal disorders.\n     * Subjects with any other ocular conditions that may influence the retinal or optic nerve structure.\n   * Refractive Errors:\n\n     * Subjects with high myopia (\\>6 diopters) or high hyperopia (\\>3 diopters).\n     * Subjects with significant astigmatism (\\>2 dioptres) or other refractive errors.\n   * Ocular Surgery History: Subjects with a history of ocular surgery, particularly involving the lens, cornea, retina, or optic nerve (e.g., laser vision correction, retinal surgeries, etc.).\n   * Subjects with significant ocular trauma, corneal abnormalities, or active ocular infections that may interfere with OCT imaging.\n   * Subjects with diabetes mellitus\n2. Healthy volunteers\n\n   * The subject has donated blood (450 ml) within the last 4 weeks\n   * Known reproductive tract malignancy\n   * A history of symptoms suggestive of endometriosis or chronic pelvic pain\n   * Ocular Diseases:\n\n     * Subjects with clinically diagnosed glaucoma, optic neuropathy, optic neuritis, cataracts, or other conditions that affect the ocular structures.\n     * Subjects with age-related macular degeneration, retinal vascular diseases, or other retinal disorders.\n     * Subjects with any other ocular conditions that may influence the retinal or optic nerve structure.\n   * Refractive Errors:\n\n     * Subjects with high myopia (\\>-6 dioptres) or high hyperopia (\\>+6 dioptres).\n     * Subjects with significant astigmatism (\\>2 dioptres) or other refractive errors.\n   * Ocular Surgery History: Subjects with a history of ocular surgery, particularly involving the lens, cornea, retina, or optic nerve (e.g., laser vision correction, retinal surgeries, etc.).\n   * Subjects with significant ocular trauma, corneal abnormalities, or active ocular infections that may interfere with OCT imaging.\n   * Subjects with diabetes mellitus","locations":[{"facility":"University of Edinburgh","city":"Edinburgh","state":"Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kexin Dong","phone":"+447301394870","email":"K.Dong-2@sms.ed.ac.uk"}],"primaryOutcomes":["Choroidal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)","Retinal Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)","Retinal Nerve Fiber Layer (RNFL) Thickness (Optical Coherence Tomography, Heidelberg SPECTRALIS)","Macular Volume (Optical Coherence Tomography, Heidelberg SPECTRALIS)","Retinal Vessel Density (Optical Coherence Tomography Angiography, Heidelberg SPECTRALIS)"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["edinburgh-united-kingdom"],"enrichment":{"headline":"Retinal Imaging for Systemic Inflammation in Endometriosis","inPlainEnglish":"There is increasing evidence that examining our eyes can tell us a lot of information about our health, and systemic diseases. Our plan is to compare the images taken of the back of eyes of women who have endometriosis with those of women who don't.","whoItsFor":["Ages 18 Years to any","Women only","Participants with a previous surgical or imaging diagnosis of endometriosis","Pre-menopausal women and those assigned female at birth","Aged 18 years and over","A past surgical or imaging diagnosis of endometriosis within the last 5 years from date of consent","Women and those assigned female at birth","No history of endometriosis or chronic pelvic pain"],"whoShouldSkip":["Participants with a previous surgical or imaging diagnosis of endometriosis","The subject has donated blood (450 ml) within the last 4 weeks","Known reproductive tract malignancy","Subjects with clinically diagnosed glaucoma, optic neuropathy, optic neuritis, cataracts, or other conditions that affect the ocular structures","Subjects with age-related macular degeneration, retinal vascular diseases, or other retinal disorders","Subjects with any other ocular conditions that may influence the retinal or optic nerve structure","Subjects with high myopia (\\>6 diopters) or high hyperopia (\\>3 diopters)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Edinburgh. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.110Z"},{"nctId":"NCT07233278","title":"High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety","officialTitle":"High-intensity, Low-frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex for Acute Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Generalized Anxiety Disorder: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-rTMS-2)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Shenyang Medical College","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are:\n\nDoes 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation?\n\nDoes 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation?\n\nResearchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity.\n\nParticipants will:\n\nUndergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC;\n\nHave continuous electrocardiography (ECG) recordings collected during the entire stimulation session;\n\nComplete clinical and psychiatric assessments before participation.","conditions":["Recurrent Pregnancy Loss(RPL)","Anxiety"],"keywords":["Recurrent pregnancy loss","Anxiety","Dorsolateral Prefrontal Cortex","Cardiac Autonomic Regulation","repetitive transcranial magnetic stimulation"],"interventions":[{"type":"DEVICE","name":"Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles"},{"type":"DEVICE","name":"Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles"}],"enrollment":48,"startDate":"2025-11-19","completionDate":"2026-06-22","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* (i) Female, aged 18-45 years, and right-handed;\n* (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;\n* (iii) Not currently pregnant or in a state of missed miscarriage;\n* (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17.\n\nExclusion Criteria:\n\n* (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;\n* (ii) Unstable blood pressure (systolic \\>180 mmHg or \\<90 mmHg);\n* (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;\n* (iv) Significant suicide risk;\n* (v) Other current major psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium. To preserve diagnostic homogeneity of the study sample, participants whose current primary diagnosis is another anxiety-related disorder will also be excluded, including panic disorder, social anxiety disorder, separation anxiety disorder, specific phobia, obsessive-compulsive and related disorders, and trauma- and stressor-related disorders; Current use of psychotropic medication at screening, or continuous use within the 4 weeks before screening of antidepressants, anxiolytics, antipsychotics, mood stabilizers, or sedative-hypnotics, in order to minimize hemodynamic confounding.","locations":[{"facility":"The Second Affiliated Hospital of Shenyang Medical College","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Hospital Affiliated to Shenyang Medical College","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"242 Hospital Affiliated to Shenyang Medical College","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fei Meng, MD","phone":"86-024-85715635","email":"mengfei665@sohu.com"},{"name":"Lin Tao, MM","phone":"86-18802401698","email":"1939908868@qq.com"}],"primaryOutcomes":["The primary endpoint will be the between-group difference in baseline-corrected mean heart rate, averaged across stimulation time windows."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["shenyang-china"],"enrichment":{"headline":"Not a traditional drug phase: Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles for Recurrent Pregnancy Loss(RPL)","inPlainEnglish":"The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are: Does 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation?","whoItsFor":["Ages 18 Years to 45 Years","Women only","(i) Female, aged 18-45 years, and right-handed;","(ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;","(iii) Not currently pregnant or in a state of missed miscarriage;","(iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17"],"whoShouldSkip":["(i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;","(ii) Unstable blood pressure (systolic \\>180 mmHg or \\<90 mmHg);","(iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;","(iv) Significant suicide risk;"],"whatHappens":"If you join, the listed intervention(s) are Rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles, or Sham rhythmic repetitive transcranial magnetic stimulation (rTMS) at 120% RMT, 1 Hz, 60-s cycles. The registry lists allocation as randomized. The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 48 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.345Z"},{"nctId":"NCT07234032","title":"An Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)","officialTitle":"A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Insmed Incorporated","sponsorClass":"INDUSTRY","summary":"The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).","conditions":["Pulmonary Hypertension","Interstitial Lung Disease"],"keywords":["pulmonary hypertension, interstitial lung disease"],"interventions":[{"type":"DRUG","name":"Treprostinil Palmitil Inhalation Powder"},{"type":"DRUG","name":"Placebo"}],"enrollment":344,"startDate":"2026-07-20","completionDate":"2031-01-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380).\n* Capable of giving signed informed consent that includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n* Agree not to participate in any other interventional trials or use investigational drugs or devices while participating in the INS1009-312 study.\n\nExclusion Criteria\n\n* Participants who experienced any adverse events (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant.\n* Current use or expected need for pulmonary arterial hypertension (PAH)-approved therapy, including prostacyclin, prostacyclin analogues or other prostacyclin receptor agonists, endothelin receptor antagonists, and/or soluble guanylate cyclase stimulator, or any PH-ILD approved treprostinil therapy. Use of phosphodiesterase 5 inhibitors in line with applicable guidelines is allowed.\n* Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema).\n* Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH.\n* Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine).\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"USA006","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA003","city":"Bend","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CZE001","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FRA003","city":"Le Kremlin-Bicêtre","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GEO003","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"DEU010","city":"Gauting","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"DEU006","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"JPN004","city":"Narita","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"JPN007","city":"Yokohama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"KOR001","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"ESP006","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"ESP003","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Insmed Incorporated","phone":"18444467633","email":"medicalinformation@insmed.com"}],"primaryOutcomes":["Number of Participants Who Experienced at Least One Treatment-Emergent Adverse Events (TEAEs)"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["naples-florida","bend-oregon","prague-czechia","le-kremlin-bic-tre-france","tbilisi-georgia","gauting-germany","m-nchen-germany","narita-japan","yokohama-japan","seoul-south-korea","madrid-spain"],"enrichment":{"headline":"Phase 3: testing Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension","inPlainEnglish":"The primary objective of this study is to measure the whether it is safe and how hard side effects are to live with of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).","whoItsFor":["Ages 18 Years to any","Participants who have completed the lead-in PH-ILD TPIP Study INS1009-311 (NCT07179380)","Agree not to participate in any other treatment trials or use investigational drugs or devices while participating in the INS1009-312 study"],"whoShouldSkip":["Participants who experienced any side effects (AEs) evaluated as causally related to TPIP by the Investigator in a lead-in study, which in the opinion of the Investigator, could pose an unreasonable risk of continued treatments for the participant","Diagnosis of Pulmonary Hypertension World Health Organisation (WHO) Groups 1, 2, 4, or 5, or subtypes of PH WHO Group 3 other than interstitial lung disease (including combined pulmonary fibrosis and emphysema)","Evidence of left ventricular failure, heart failure with preserved ejection fraction (HFpEF) or postcapillary PH","Known hypersensitivity or contraindication to treprostinil or TPIP or TPIP formulation excipients (eg, mannitol, leucine)","Note: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Treprostinil Palmitil Inhalation Powder, or Placebo. The registry lists allocation as na. The primary objective of this study is to measure the whether it is safe and how hard side effects are to live with of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 344 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.035Z"},{"nctId":"NCT07235059","title":"Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","officialTitle":"A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.","conditions":["Chronic Kidney Disease"],"keywords":["OJR520","safety and tolerability","PK","PD","healthy volunteers","first in human","chronic kidney disease"],"interventions":[{"type":"DRUG","name":"OJR520"},{"type":"OTHER","name":"Placebo"}],"enrollment":112,"startDate":"2025-11-20","completionDate":"2028-01-21","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAble to provide written informed consent before any assessment is performed.\n\nPart A (HV):\n\n• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.\n\nParts B \\& C (CKD)\n\n• Male and female participants 18 to 65 years of age.\n\nExclusion Criteria:\n\n* Women of childbearing potential.\n* Sexually active males unwilling to use contraception.\n\nPart A (HV):\n\n* Clinically significant abnormal blood pressure, defined as SBP \\<90 mmHg or \\>140 mmHg or DBP \\<55 mmHg or \\>95 mmHg.\n* Abnormal resting HR, defined as \\<45 bpm or \\>90 bpm.\n\nPart B \\& C (CKD)\n\n* History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.\n* Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.\n* History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).\n\nOther protocol defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Quotient Sciences Sea View","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["miami-florida","berlin-germany"],"enrichment":{"headline":"Phase 1: testing OJR520 for Chronic Kidney Disease","inPlainEnglish":"The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.","whoItsFor":["Ages 18 Years to 65 Years","Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range","Male and female participants 18 to 65 years of age"],"whoShouldSkip":["Women of childbearing potential","Sexually active males unwilling to use contraception","Clinically significant abnormal blood pressure, defined as SBP \\<90 mmHg or \\>140 mmHg or DBP \\<55 mmHg or \\>95 mmHg","Abnormal resting HR, defined as \\<45 bpm or \\>90 bpm","Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography","History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA)","Other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are OJR520, or Placebo. The registry lists allocation as randomized. The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 112 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.486Z"},{"nctId":"NCT07235280","title":"Testing the Safety of Dapagliflozin Prior to Surgery for the Treatment of Patients With Stage IA Lung Adenocarcinoma","officialTitle":"An Open-Label Safety and Tolerability Pilot Study of Dapagliflozin in Stage IA Lung Adenocarcinoma","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Jonsson Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma. Dapagliflozin is approved by the Food and Drug Administration (FDA) for the treatment of diabetes and heart failure. It is an SGLT2 inhibitor. Stage I lung adenocarcinomas express significantly higher levels of the SGLT2 protein than other stages, and research suggests that SGLT2 inhibition improves lung cancer outcomes in patients with diabetes. In this study, dapagliflozin is being used off-label, which means it is being used for a condition that it was not originally approved for by the FDA. The investigational study drug is a neoadjuvant treatment, meaning the drug is given before surgery to try and help make the surgery more effective.","conditions":["Lung Adenocarcinoma","Stage IA1 Lung Cancer American Joint Committee on Cancer (AJCC) v8","Stage IA2 Lung Cancer AJCC v8","Stage IA3 Lung Cancer AJCC v8","Lung Cancer"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography Assisted Biopsy"},{"type":"DRUG","name":"Dapagliflozin Propanediol"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":48,"startDate":"2025-12-02","completionDate":"2028-06-29","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be able to provide written informed consent\n* Male or female ≥ 22 years of age at visit 1\n* Histologically confirmed stage Ia lung adenocarcinoma, with availability of biopsy tissue for Ki-67 determination\n* Planning to undergo surgery for lung adenocarcinoma\n* Willing and able to receive a research CT-guided lung biopsy\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n* Leukocytes ≥ 3.0 K/mm\\^3\n* Absolute neutrophil count ≥ 1.5 K/mm\\^3\n* Platelets ≥ 100 K/mm\\^3\n* Total bilirubin ≤ 2 mg/dl\n* Aspartate aminotransferase (AST) ≤ 62 IU/L\n* Alanine aminotransferase (ALT) ≤ 70 IU/L\n* Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\\^2\n* Diabetic status: diabetic subjects who are not currently receiving treatment will be included in the study. Diabetic subjects who are under treatment with insulin or oral anti-diabetic drugs will be enrolled under observation by endocrinologists on the team, to adjust the dose of the standard of care diabetic drugs to prevent hypoglycemia\n* Females of child-bearing potential must have a negative pregnancy test during screening and be neither breastfeeding nor intending to become pregnant during study participation. Females of childbearing potential must agree to avoid pregnancy during the study and omit to abstinence from heterosexual intercourse or agree to use two methods of birth control (one highly effective method and one additional effective method) at least 4 weeks before the start of protocol therapy\n* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Women of child-bearing age will receive a urine pregnancy test to confirm eligibility\n* Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study\n* Current or previous treatment with SGLT2 inhibitors\n* History of other malignancies with exception of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma\n* Currently receiving any other investigational agents\n* Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, ketoacidosis, severe kidney disease (estimated glomerular filtration rate \\[eGFR\\] \\< 30 mL/min/1.73m\\^2)\n* Subjects with HIV are eligible unless their cluster of differentiation 4 (CD4+) T-cell counts are \\< 350 cells/µL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective antiretroviral therapy (ART) according to Department of Health and Human Services (DHHS) treatment guidelines is recommended","locations":[{"facility":"UCLA / Jonsson Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amanda R. Gonzalez","phone":"310-794-4376","email":"rngonzalez@mednet.ucla.edu"},{"name":"Tina Tieu","phone":"310-633-8400","email":"TinaTieu@mednet.ucla.edu"}],"primaryOutcomes":["Incidence of adverse events"],"hasResults":false,"conditionSlugs":["lung-cancer","heart-failure"],"drugSlugs":["dapagliflozin"],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Early phase 1: testing Dapagliflozin Propanediol for Lung Adenocarcinoma","inPlainEnglish":"This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma. Dapagliflozin is approved by the Food and Drug Administration (FDA) for the treatment of diabetes and heart failure.","whoItsFor":["Ages 22 Years to any","Male or female ≥ 22 years of age at visit 1","Histologically confirmed stage Ia lung adenocarcinoma, with availability of biopsy tissue for Ki-67 determination","Planning to undergo surgery for lung adenocarcinoma","Willing and able to receive a research CT-guided lung biopsy","Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1","Leukocytes ≥ 3.0 K/mm\\^3","Absolute neutrophil count ≥ 1.5 K/mm\\^3"],"whoShouldSkip":["Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. Women of child-bearing age will receive a urine pregnancy test to confirm eligibility","Unsuitable candidate for the study, based on the opinion of the Investigator (e.g., cognitive impairment), such that participation might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements or complete the study","Current or previous treatment with SGLT2 inhibitors","History of other malignancies with exception of malignancies for which all treatment was completed at least 2 years before registration with no evidence of disease and locally treated skin squamous or basal cell carcinoma","Currently receiving any other investigational agents","Currently receiving regularly scheduled systemic steroids in the form of prednisone or dexamethasone (more than 10 mg prednisone daily or equivalent). Topical steroid ointments or creams for occasional skin rash is allowed","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Computed Tomography Assisted Biopsy, or Dapagliflozin Propanediol. The registry lists allocation as na. This early phase I trial tests the safety and side effects of dapagliflozin given prior to surgery in patients with stage IA lung adenocarcinoma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 48 people at Los Angeles. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.947Z"},{"nctId":"NCT07235384","title":"A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis","officialTitle":"A Phase 1/1b Randomized, Double Blind, Placebo-controlled, Single and Multiple Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis (AD)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Zai Lab (Shanghai) Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)","conditions":["Atopic Dermatitis (AD)"],"keywords":["Atopic Dermatitis"],"interventions":[{"type":"DRUG","name":"ZL-1503"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"ZL-1503"},{"type":"DRUG","name":"Placebo"}],"enrollment":84,"startDate":"2025-12-01","completionDate":"2027-12-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Part A:\n\n  1. Healthy male and female volunteers, 18-65 years of age\n  2. Body mass index (BMI) between ≥ 18.5 and \\< 32.5 kg/m2\n  3. Negative pregnancy tests for women of childbearing potential.\n* Part B:\n\n  1. 18-65 years of age;\n  2. BMI between ≥18.5 and \\<40.0 kg/m2\n  3. Have a diagnosis of AD at least 12 months prior to Day 1;\n  4. Moderate-to-severe AD at Screening and Baseline visit, defined as:\n\n     1. Eczema Area and Severity Index (EASI) score ≥ 16;\n     2. Affected Body Surface Area (BSA)≥ 10%;\n     3. vIGA-AD™ score ≥ 3\n  5. History of an inadequate response to treatment with topical medications\n  6. Average peak pruritus numeric rating scale (PP-NRS) score ≥4 in the 7 days before randomization.\n  7. Negative pregnancy tests for women of childbearing potential.\n\nExclusion Criteria:\n\n* Part A and B:\n\n  1. Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases.\n  2. History of major metabolic, liver, kidney, hematologic or other significant disorders.\n  3. Abnormal Electrocardiogram (ECG) findings\n  4. Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function, in the investigator's judgment, make the participant unsuitable for study participation.\n  5. History of drug abuse or addiction within 6 months prior to screening\n  6. Donated \\>500mL blood within 2 months of dosing.\n* For Part B only:\n\n  1. Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments.\n  2. Uncontrolled chronic disease that might require bursts of oral corticosteroids.\n  3. Any other sound medical, psychiatric, and/or social reason as determined by the investigator.\n  4. Smoke \\> 10 cigarettes or the equivalent (including electronic cigarettes) per day.","locations":[{"facility":"Veracity Clinical Research","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Health Institute","city":"Carlton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Fujian Medical University","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Hospital of Jiangxi Province","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong Provincial Dermatology Hospital","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Skin Disease Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hangzhou First People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aotearoa Clinical Trials","city":"Auckland","state":"Auckland","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Auckland","city":"Takapuna","state":"Auckland","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Hamilton","city":"Hamilton","state":"Hamilton","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Palmerston North","city":"Palmerston North","state":"Mananwatu","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Hutt Valley","city":"Upper Hutt","state":"Wellington Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Kapiti","city":"Waikanae","state":"Wellington Region","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ZaiLab Medical Director","phone":"+86 021-61632588","email":"ZaiLab_1503-001_StudyTeam@zailaboratory.com"}],"primaryOutcomes":["Number of participants with adverse events (AEs)","Number of participants with serious adverse events (SAEs)","Number of participants with clinical laboratory abnormalities","Number of participants with vital sign abnormalities","Number of participants with electrocardiogram (ECG) abnormalities"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["woolloongabba-australia","carlton-australia","beijing-china","fuzhou-china","nanchang-china","jinan-china","shanghai-china","hangzhou-china","auckland-new-zealand","takapuna-new-zealand","hamilton-new-zealand","palmerston-north-new-zealand","upper-hutt-new-zealand","waikanae-new-zealand"],"enrichment":{"headline":"Phase 1: testing ZL-1503 for Atopic Dermatitis (AD)","inPlainEnglish":"This is a phase 1/1b randomly assigned, double blind, compared with a dummy treatment, single dose escalation (SAD) and multiple dose escalation (MAD) study to measure the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)","whoItsFor":["Ages 18 Years to 65 Years","Healthy male and female volunteers, 18-65 years of age","Body mass index (body-mass index (BMI)) between ≥ 18.5 and \\< 32.5 kg/m2","Negative pregnancy tests for women of childbearing potential","18-65 years of age;","body-mass index (BMI) between ≥18.5 and \\<40.0 kg/m2","Have a diagnosis of AD at least 12 months prior to Day 1;","Moderate-to-severe AD at Screening and Baseline visit, defined as:"],"whoShouldSkip":["Significant health issues, such as positive tests for human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), active tuberculosis, immunodeficiencies or autoimmune diseases","History of major metabolic, liver, kidney, hematologic or other significant disorders","Abnormal Electrocardiogram (ECG) findings","Clinically relevant abnormal lab results, including low blood counts, or abnormal liver and kidney function, in the investigator's judgment, make the participant unsuitable for study participation","History of drug abuse or addiction within 6 months prior to screening","Donated \\>500mL blood within 2 months of dosing","Presence of dermatologic conditions and/or comorbidities that might confound the diagnosis of AD and/or might interfere with study assessments"],"whatHappens":"If you join, the listed intervention(s) are ZL-1503, Placebo, or ZL-1503. The registry lists allocation as randomized. This is a phase 1/1b randomly assigned, double blind, compared with a dummy treatment, single dose escalation (SAD) and multiple dose escalation (MAD) study to measure the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 84 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.825Z"},{"nctId":"NCT07237594","title":"IL-17 Blockade to Decrease irAEs (REPLAY)","officialTitle":"A Feasibility Study Utilizing IL-17 Blockade to Decrease Risk of Immune Related Adverse Events","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"The primary objective of this study is to determine the safety and feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody, (Secukinumab, Cosentyx®) to participants with metastatic melanoma who have previously received immune checkpoint inhibitor (ICI) therapy, experienced an immune related adverse event (colitis, hepatitis, skin rash, psoriatic arthritis) to ICI, and are re-initiating ICI therapy.","conditions":["Metastatic Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Secukinumab Injection"}],"enrollment":4,"startDate":"2026-03-12","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Histologically confirmed advanced metastatic melanoma\n2. Participants of any gender who are at least 18 years of age on the day of signing informed consent\n3. Participants must be planned or scheduled by their treating physician to receive PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care. Patients should either be restarting the same ICI regimen which contributed to the prior toxicity or have a clinical need to escalate to doublet (combination) ICI therapy, plan for therapy should be reviewed by the PI of this study.\n4. Participant (or legally acceptable representative if applicable) provides written informed consent for the trial\n5. Participant must have had prior treatment with ICI therapy (either PD-1 therapy or PD-1 plus anti LAG3 or PD-1 plus anti CTLA-4 therapy as standard of care) and experienced grade 2 or higher immune-related colitis, hepatitis, or skin rash leading to treatment interruption or discontinuation or requiring steroid administration (systemic or topical).\n\n   * Note that patients who experience more than one irAEs are eligible to participate\n6. Adequate organ function as defined below. Standard of care labs drawn within 42 days prior to consent may be used for the purposes of determining eligibility.\n\n   * Absolute Neutrophil Count (ANC) ≥ 1500/µL\n   * Platelets ≥ 100,000/µL\n   * Hemoglobin\\* ≥ 9.0 g/dL or ≥ 5.6 mmol/L \\*Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the previous 2 weeks\n   * AST/ALT 2.5x upper limit of normal\n\nExclusion Criteria:\n\n1. Uveal melanoma\n2. Any participants known to be pregnant or breastfeeding.\n3. Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy\n4. Patients with symptomatic CNS metastases and/or carcinomatous meningitis\n\n   * Patients with asymptomatic, clinically stable CNS metastases are allowed provided they do not require steroid treatment\n5. History of or active (non-infectious) pneumonitis that required steroids\n6. Active infection requiring systemic therapy\n7. Known history of Human Immunodeficiency Virus (HIV) infection\n8. Known history of Hepatitis B or known active Hepatitis C virus infection. NOTE: no testing for Hepatitis B or Hepatitis C is required\n9. Known history of active TB (Bacillus Tuberculosis)\n10. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or make it not in the best interest of the subject to participate, in the opinion of the treating physician\n11. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n12. History of allogenic tissue or solid organ transplant\n13. History of active autoimmune disease requiring systemic therapy within the past 12 months, with the exception of ICI induced irAEs.\n14. Has not been treated with secukinumab within the last 12 months\n15. History of prior cardiac, neurologic, ocular IRAE related to ICI; history of blistering cutaneous IRAE related to ICI","locations":[{"facility":"Duke University Health System","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"April Salama, MD","phone":"+1 919 681 9507","email":"april.salama@duke.edu"},{"name":"Emily Bolch","phone":"","email":"emily.bolch@duke.edu"}],"primaryOutcomes":["Safety of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)","Feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody (secukinumab) as determined by occurrence of immune-related Adverse Events (irAEs)"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Phase 1: testing Secukinumab Injection for Metastatic Melanoma","inPlainEnglish":"The primary objective of this study is to determine the safety and feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody, (Secukinumab, Cosentyx®) to participants with metastatic melanoma who have previously received immune checkpoint inhibitor (ICI) therapy, experienced an immune related adverse event (colitis, hepatitis, skin rash, psoriatic arthritis) to ICI, and are re-initiating ICI therapy.","whoItsFor":["Ages 18 Years to any","Histologically confirmed advanced metastatic melanoma","Note that patients who experience more than one irAEs are eligible to participate","Adequate organ function as defined below. Standard of care labs drawn within 42 days prior to consent may be used for the purposes of determining eligibility","Absolute Neutrophil Count (ANC) ≥ 1500/µL","Platelets ≥ 100,000/µL","Hemoglobin\\* ≥ 9.0 g/dL or ≥ 5.6 mmol/L \\*Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within the previous 2 weeks","AST/ALT 2.5x upper limit of normal"],"whoShouldSkip":["Any participants known to be pregnant or breastfeeding","Known diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (in doses exceeding 10 mg daily of prednisone or equivalent), or any other form of immunosuppressive therapy within 7 days prior to first research biopsy","Patients with symptomatic CNS metastases and/or carcinomatous meningitis","Patients with asymptomatic, clinically stable CNS metastases are allowed provided they do not require steroid treatment","History of or active (non-infectious) pneumonitis that required steroids","Active infection requiring systemic therapy","Known history of Human Immunodeficiency Virus (HIV) infection"],"whatHappens":"If you join, the listed intervention(s) are Secukinumab Injection. The registry lists allocation as na. The primary objective of this study is to determine the safety and feasibility of administering an IL-17A (human IgG1κ) monoclonal antibody, (Secukinumab, Cosentyx®) to participants with metastatic melanoma who have previously received immune checkpoint inhibitor (ICI) therapy, experienced an immune related adverse event (colitis, hepatitis, skin rash, psoriatic arthritis) to ICI, and are re-initiating ICI therapy.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 4 people at Durham. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.805Z"},{"nctId":"NCT07237750","title":"iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss","officialTitle":"iWAIST Trial: A Multicenter, Single-Blind, Randomized, Sham-Controlled Trial of Endoscopic Radial Compression Gastroplasty (ERCG) Plus Optimized Lifestyle Intervention for Weight Management in Chinese Adults With Overweight or Mild-to-Moderate Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Liu Yan","sponsorClass":"OTHER","summary":"This randomized, sham-controlled trial evaluates the efficacy and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity. The co-primary outcomes are percentage total weight loss (%TWL) at 12 weeks and the clinical response rate at 12 weeks, defined as the proportion of participants achieving %TWL ≥5%. Secondary outcomes include weight-related, metabolic, hepatic steatosis-related, imaging, symptom, quality-of-life, and safety outcomes.","conditions":["Overweight and/or Obesity","Metabolic Syndrome","Nonalcoholic Fatty Liver Disease"],"keywords":["Endoscopic gastroplasty","Endoscopic bariatric therapy","Weight loss","Overweight","Gastric volume reduction","Chinese","Obesity"],"interventions":[{"type":"PROCEDURE","name":"Endoscopic Radial Compression Gastroplasty"},{"type":"BEHAVIORAL","name":"Optimized Lifestyle Intervention (OLI)"},{"type":"PROCEDURE","name":"Sham Endoscopic Procedure"}],"enrollment":216,"startDate":"2026-03-13","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Asian adults aged 18-65 years.\n* BMI 24.0-27.9 with ≥ 1 obesity-related complication\n* BMI 28.0-37.4kg/m²\n* Failed prior conservative weight loss attempts\n* Willingness to comply with follow-up.\n* Provided written informed consent.\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery with clinically relevant sequelae.\n* Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric/duodenal ulcer), or neoplastic lesions.\n* Any condition associated with an increased risk of upper gastrointestinal bleeding.\n* Hiatal hernia \\>2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control.\n* Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum).\n* Achalasia or other severe esophageal motility disorder.\n* Severe coagulopathy.\n* Insulin-dependent diabetes mellitus.\n* Chronic abdominal pain.\n* Gastrointestinal motility disorder (e.g., gastroparesis).\n* Hepatic impairment or cirrhosis.\n* Severe or uncontrolled psychiatric illness.\n* Alcohol abuse or substance dependence.\n* Unwilling to participate in a physician-supervised diet/behavior modification program and/or unwilling to comply with routine follow-up.\n* Daily regular use of NSAIDs, anticoagulants, or other gastric-irritating medications.\n* Unable or unwilling to take proton pump inhibitor (PPI) therapy as prescribed during the treatment period.\n* Known or suspected hypersensitivity to any material/component of the study system.\n* Pregnant or breastfeeding.\n* Severe cardiopulmonary disease or other serious systemic/organic disease.\n* Active infection not successfully eradicated before enrolment.\n* Use of time-critical medications potentially affected by altered gastric emptying (e.g., antiepileptics, antiarrhythmics).\n* Current systemic corticosteroids, immunosuppressants, or opioid analgesics.\n* Use of any weight-loss medication within the past 3 months or current use.\n* Prior use of any intragastric device.\n* Participation in a weight-affecting clinical trial within the past 6 months.\n* Symptomatic congestive heart failure, clinically significant arrhythmia, or unstable coronary artery disease.\n* Clinically significant respiratory disease.\n* Autoimmune connective tissue disease.\n* Life expectancy \\<1 year or severe renal/hepatic/pulmonary or other serious medical illness.\n* Known genetic or endocrine cause of obesity (e.g., hypothyroidism, Prader-Willi syndrome) or other endocrine disease known to affect body weight.\n* Eating disorder (e.g., night eating syndrome, bulimia nervosa, binge eating disorder, compulsive eating).","locations":[{"facility":"The fifth Medical Center of Chinese PLA General Hospital, Beijing","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yan Liu, M.D. PH.D.","phone":"+8601066947300","email":"13911798288@163.com"},{"name":"Yiyu Qiao, M.D. PH.D.","phone":"+8601066947300","email":"qyy96@126.com"}],"primaryOutcomes":["Percent Total Body Weight Loss (%TBWL)","Clinical Responder Rate (CRR)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Endoscopic Radial Compression Gastroplasty for Overweight and/or Obesity","inPlainEnglish":"This randomly assigned, sham-controlled trial evaluates the how well it works and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity. The co-primary outcomes are percentage total weight loss (%TWL) at 12 weeks and the clinical response rate at 12 weeks, defined as the proportion of participants achieving %TWL ≥5%.","whoItsFor":["Ages 18 Years to 65 Years","Asian adults aged 18-65 years","body-mass index (BMI) 24.0-27.9 with ≥ 1 obesity-related complication","Failed prior conservative weight loss attempts","Willingness to comply with follow-up"],"whoShouldSkip":["Prior gastrointestinal surgery with clinically relevant sequelae","Active or clinically significant gastrointestinal disease, including inflammatory conditions (e.g., esophagitis, Barrett's esophagus, Crohn's disease), peptic ulcer disease (gastric/duodenal ulcer), or neoplastic lesions","Any condition associated with an increased risk of upper gastrointestinal bleeding","Hiatal hernia \\>2 cm or severe/refractory gastroesophageal reflux disease (GERD); acid reflux requiring ≥2 medications for symptom control","Esophageal/pharyngeal structural abnormalities that may impede endoscope passage (e.g., stricture, diverticulum)","Achalasia or other severe esophageal motility disorder","Severe coagulopathy"],"whatHappens":"If you join, the listed intervention(s) are Endoscopic Radial Compression Gastroplasty, Optimized Lifestyle Intervention (OLI), or Sham Endoscopic Procedure. The registry lists allocation as randomized. This randomly assigned, sham-controlled trial evaluates the how well it works and safety of ERCG plus optimized lifestyle intervention compared with sham procedure plus optimized lifestyle intervention in Chinese adults with overweight accompanied by at least one metabolic comorbidity or with mild-to-moderate obesity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 216 people at Beijing. Taking part typically means following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.154Z"},{"nctId":"NCT07239323","title":"In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies","officialTitle":"In Vivo-Generated Chimeric Antigen Receptor T-Cell Therapy for the Treatment of Relapsed or Refractory Hematologic Malignancies","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chongqing Precision Biotech Co., Ltd","sponsorClass":"INDUSTRY","summary":"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.\n\nIt is an early exploratory clinical study of the safety, tolerability and initial efficacy in the treatment of relapsed or refractory malignant hematological tumors.","conditions":["B-Acute Lymphoblastic Leukemia","B Cell Non-Hodgkin's Lymphoma","Multiple Myeloma"],"keywords":["in Vivo","CAR-T","malignant hematological tumors"],"interventions":[{"type":"BIOLOGICAL","name":"Invivo CAR-T"}],"enrollment":24,"startDate":"2025-07-01","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years old, gender unrestricted;\n2. Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;\n3. ECOG performance status score 0-2, with an expected survival period of ≥ 3 months;\n4. Blood routine test results during the screening period meet the following criteria:\n\n   ① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL;\n   * Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL;\n5. Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula);\n6. Liver function during the screening period meets the following criteria:\n\n   ① Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 3.0 × ULN;\n\n   ② Total bilirubin (TBIL) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia such as Gilbert's syndrome, direct bilirubin can be relaxed to ≤ 1.5 × ULN);\n7. Cardiac function during the screening period meets the following criteria:\n\n   ① Left ventricular ejection fraction (LVEF) ≥ 40% (measured by echocardiography or MUGA scan);\n\n   ② No clinically significant pericardial effusion;\n\n   ③ No clinically significant electrocardiogram (ECG) abnormalities;\n8. Pulmonary function during the screening period meets the following criteria: blood oxygen saturation (SpO₂) ≥ 90%;\n9. Women of childbearing age must have a negative pregnancy test during the screening period and before drug administration, and must not be in the lactation period;\n10. Men and women of childbearing age must agree to take effective contraceptive measures and not donate reproductive cells (including sperm or eggs) from the time of signing the informed consent form until 1 year after the end of study drug administration;\n11. The subject or their legally authorized representative has signed the informed consent form (ICF), indicating their understanding of the purpose and procedures of the study and their voluntary participation in this study.\n\nExclusion Criteria:\n\n1. Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):\n\n   ① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;\n\n   ② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);\n2. History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;\n3. History of other malignant tumors (except for this disease), except for the following situations:\n\n   ① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;\n\n   ② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;\n4. Received treatment related to vesicular stomatitis virus glycoprotein (VSVG) pseudotyped virus in the past;\n5. Had severe and uncontrolled infections (bacterial, viral, fungal, etc.) within the screening period;\n6. Clinically significant cardiac diseases:\n\n   * Had symptomatic heart failure or other serious cardiac diseases (such as severe arrhythmia);\n\n     * Had New York Heart Association (NYHA) Class III-IV congestive heart failure; ③ Had a myocardial infarction or received coronary artery bypass grafting (CABG) / coronary artery stent implantation within 6 months before signing the informed consent;\n\n       * Had clinically significant ventricular arrhythmia or a history of unexplained syncope; ⑤ Had a history of syncope (excluding cases caused by vasovagal reactions or dehydration); ⑥ Had a history of severe non-ischemic cardiomyopathy;\n7. Other clinically significant diseases, including but not limited to:\n\n   * Primary immunodeficiency; ② Had a stroke or seizure within 6 months before screening;\n\n     * Had clear clinical evidence of dementia or mental status changes; ④ Had Parkinson's disease, Parkinson-like movement disorders or a history of the above;\n8. Had undergone surgery within 2 weeks before administration, or planned to undergo surgery within 2 weeks after administration (local anesthesia surgery excluded);\n9. Had received live attenuated vaccines within 1 month before administration;\n10. Had a history of severe allergic reactions to this product or its formulation components;\n11. Patients who were not suitable for establishing intravenous access;\n12. The investigator believed that there were other conditions that made the patient unsuitable for participating in this study.","locations":[{"facility":"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China","city":"Kunming","state":"Yunnan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wang Sanbin, PhD","phone":"+86 13187424131","email":"sanbin1011@163.com"}],"primaryOutcomes":["Maximal Tolerated Dose(MTD)","Incidence of adverse events(AE) after infusion"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","multiple-myeloma"],"drugSlugs":["car-t"],"locationSlugs":["kunming-china"],"enrichment":{"headline":"Phase 1: testing Invivo CAR-T for B-Acute Lymphoblastic Leukemia","inPlainEnglish":"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors. It is an early exploratory clinical study of the safety, tolerability and initial how well it works in the treatment of relapsed or refractory malignant hematological tumors.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years old, gender unrestricted;","Confirmed diagnosis of relapsed/refractory malignant hematological tumors, including B-ALL, B-cell lymphoma and multiple myeloma;","how well you can do daily activities (ECOG score) score 0-2, with an expected survival period of ≥ 3 months;","Blood routine test results during the screening period meet the following criteria:","① Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin (rhEPO) is allowed; for patients meeting the hemoglobin ≥ 6 g/dL criterion, red blood cell transfusion can be used to maintain hemoglobin ≥ 6 g/dL;","Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor \\[G-CSF\\] within 1 week before screening, or no use of pegylated G-CSF within 2 weeks before screening); ③ Platelet count ≥ 50,000/μL; ④ Lymphocyte count ≥ 500/μL;","Normal renal function during the screening period: creatinine clearance rate (CrCl) ≥ 45 mL/min (calculated using the Cockcroft-Gault formula);"],"whoShouldSkip":["Other anti-tumor treatments within the screening period (judged by the investigator comprehensively):","① Received chemotherapy, targeted therapy or immunotherapy within 5 half-lives before administration;","② Received radiotherapy within 4 weeks before administration (if the radiotherapy target area covers ≤ 5% of bone marrow reserve, the time limit for radiotherapy completion is not restricted);","History of hematopoietic stem cell transplantation: Received allogeneic or autologous hematopoietic stem cell transplantation within 3 months before administration;","History of other malignant tumors (except for this disease), except for the following situations:","① Received radical treatment and had no known active disease for ≥ 2 years before enrollment;","② Had fully treated non-melanoma skin cancer in the past and had no active lesions at present;"],"whatHappens":"If you join, the listed intervention(s) are Invivo CAR-T. The registry lists allocation as na. This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory malignant hematological tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at Kunming. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.506Z"},{"nctId":"NCT07240220","title":"The Mother-Daughter Project: Merck-4","officialTitle":"The Mother-Daughter Project: Inclusion of Difficult-to-reach Kenyan Families, and Studies of Factors Influencing the Immune Response to HPV Vaccination (Merck-4)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Indiana University","sponsorClass":"OTHER","summary":"This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.\n\nThis project specifically aims to collect additional data on the ability for HR-HPV testing to detect premalignant lesions of the cervix, especially in HIV-infected women, to investigate and identify barriers leading to non-participation in previous MDP efforts, and to examine factors associated with the immune response to HPV vaccination among rural Kenyan girls.","conditions":["Cervical Dysplasia"],"keywords":["cervical dysplasia","cervical cancer screening","HPV infection"],"interventions":[{"type":"BIOLOGICAL","name":"Gardasil-9"},{"type":"DIAGNOSTIC_TEST","name":"High Risk HPV DNA Testing"},{"type":"PROCEDURE","name":"Visual Inspection with acetic acid (VIA) and possible cervical biopsy"}],"enrollment":2500,"startDate":"2026-07-22","completionDate":"2028-08-01","sex":"FEMALE","minAge":"9 Years","maxAge":"49 Years","healthyVolunteers":true,"eligibilityRaw":"Kenyan Adult Women\n\nInclusion Criteria:\n\n* ages 25 through 49 years\n* able/willing to sign informed consent\n* willing to participate in the community meetings\n\nExclusion Criteria:\n\n• pregnant\n\nKenyan Girls\n\nInclusion Criteria:\n\n* ages 9 through 14 years\n* have mother that is able/willing to sign informed consent for vaccination\n* can return for the second HPV vaccine dose in 6 - 12 months\n\nExclusion Criteria:\n\n• girls who are not willing or unable to return for the second HPV vaccine dose","locations":[{"facility":"Moi University","city":"Eldoret","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Phillip Tonui, MD","phone":"0722 609132","email":"tonui46@yahoo.co.uk"}],"primaryOutcomes":["Detection of CIN2/3","Local knowledge and attitudes","Barriers to participation","Factors that influence immunity to the HPV vaccine"],"hasResults":false,"conditionSlugs":["cervical-cancer","hiv"],"drugSlugs":[],"locationSlugs":["eldoret-kenya"],"enrichment":{"headline":"Not a traditional drug phase: testing Gardasil-9 for Cervical Dysplasia","inPlainEnglish":"This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya. The MDP project, since its initiation in 2018, has sought to develop a framework for the eradication of cervical cancer through effective screening of adult women and through the vaccination of female children.","whoItsFor":["Ages 9 Years to 49 Years","Women only","ages 25 through 49 years"],"whoShouldSkip":["who can join:","ages 9 through 14 years","can return for the second HPV vaccine dose in 6 - 12 months"],"whatHappens":"If you join, the listed intervention(s) are Gardasil-9, High Risk HPV DNA Testing, or Visual Inspection with acetic acid (VIA) and possible cervical biopsy. The registry lists allocation as randomized. This project serves to continue a community-based initiative, known as the Kenya Mother-Daughter Cervical Cancer Eradication Project, or the Mother-Daughter Project (MDP), in the Webuye region of Western Kenya.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 2,500 people at Eldoret. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.326Z"},{"nctId":"NCT07241390","title":"A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). Participation in the study will last about 5 years.","conditions":["Atherosclerosis Cardiovascular Disease","Chronic Kidney Disease"],"keywords":["Heart Disease","Kidney Disease","Outcomes","Stroke"],"interventions":[{"type":"DRUG","name":"Orforglipron"},{"type":"DRUG","name":"Placebo"}],"enrollment":7140,"startDate":"2025-12-01","completionDate":"2031-08","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have established ASCVD and/or CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","locations":[{"facility":"Instituto de Investigaciones Clínicas Bahia Blanca","city":"Bahía Blanca","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CONEXA Investigacion Clinica S.A.","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Buenos Aires Macula S.A","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIPREC","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Especializado (IME)","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cicemo Srl","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiología Palermo","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consultorio Medico Investigador Principal Dr Besada","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Glenny Corp. 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.502Z"},{"nctId":"NCT07242248","title":"A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and Crohn's Disease in the United Kingdom (UK)","officialTitle":"Real World Observation of Guselkumab Treatment in Patients With Ulcerative Colitis and Crohn's Disease - a Study of Treatment Outcomes in the UK","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen-Cilag Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. 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Enrolment must take place before or at the day of first administration (but after treatment decision by physician)\n* Must have a confirmed diagnosis of moderate-to-severe Crohn's Disease (CD) or Ulcerative Colitis (UC) recorded in their medical records\n* Must sign a informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion Criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya® (guselkumab), Skyrizi ® (risankizumab) and Omvoh® (mirikizumab). As an exception, participants with history of ustekinumab exposure, may be included\n* Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and /or small molecules)\n* Is unable to provide informed consent","locations":[{"facility":"London North West University Healthcare NHS Trust","city":"Harrow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)","Number of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)","Number of Participants Achieving Clinical Response for CD as Measured by HBI","Number of Participants Achieving Clinical Response for UC as Measured by PMS","Number of Participants Achieving Corticosteroid-free Remission for CD as Measured by HBI","Number of Participants Achieving Corticosteroid-free Remission for UC as Measured by PMS","Number of Participants Achieving Corticosteroid-free Clinical Response for CD as Measured by HBI","Number of Participants Achieving Corticosteroid-free Clinical Response for UC as Measured by PMS","Number of Participants Achieving Patient-Reported Outcome (PRO)-2 Corticosteroid-Free Remission for CD as Measured by HBI","Number of Participants Achieving PRO-2 Corticosteroid-Free Remission for UC as Measured by PMS"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["harrow-united-kingdom"],"enrichment":{"headline":"A Study to Observe Real-world Evidence of Guselkumab Treatment in Participants With Ulcerative Colitis and …","inPlainEnglish":"This study wants to measure the clinical effectiveness (how well the treatment works) of Guselkumab, by lines of treatment and subpopulations, and what are the outcomes of treatment (clinical outcomes) in adult participants with moderately to severely active Ulcerative Colitis (UC) or Crohn's Disease (CD) under real-world settings. 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You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 220 people at Harrow. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.897Z"},{"nctId":"NCT07244211","title":"MAPT Protocol: Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","officialTitle":"Musculoskeletal Adaptive Platform Trial (MAPT): Fixation Versus Arthroplasty Surgical Treatments for Early Recovery After HIP Fracture (FASTER-HIP)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Southern California","sponsorClass":"OTHER","summary":"This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomized, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old. We hypothesize that arthroplasty will reduce death, preserve ambulation, increase days alive and out of hospital, and improve health status compared to internal fixation within 4 months and 12 months from randomization.","conditions":["Femoral Neck Fractures"],"keywords":["Minimally displaced femoral neck fractures","arthroplasty","hip fractures","femoral fractures","orthopaedic procedures","older adults","patient-centered outcomes","adaptive trial","internal fixation","pragmatic trial"],"interventions":[{"type":"PROCEDURE","name":"Hip arthroplasty"},{"type":"PROCEDURE","name":"Internal fixation"}],"enrollment":600,"startDate":"2026-01-23","completionDate":"2029-02-28","sex":"ALL","minAge":"60 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture\n* The patient has a health condition affecting physical mobility.\n* Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging.\n* Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction.\n* Low energy injury mechanism.\n* Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery.\n\nExclusion Criteria:\n\n* The patient is not clinically suitable for either compared treatment.\n* Expected injury survival of less than 12 months.\n* Terminal illness with expected survival of less than 12 months.\n* Incarceration.\n* Unable to obtain informed consent due to language barriers.\n* Unable to obtain informed consent because the legally authorized representative was unavailable.\n* Problems, in the judgment of the study personnel, with maintaining follow-up with the patient.\n* Currently enrolled in a study or intervention domain that does not permit co-enrollment.\n* Prior enrollment in the specific platform trial intervention domain.\n* Patient or legally authorized representative did not provide informed consent (declined participation).\n* Eligible patient or legally authorized representative was not approached within the screening window (missed participant).\n* Other reasons to exclude the patient, as approved by the data coordinating center.\n* Associated lower extremity injury that prevents post-operative weight-bearing.\n* Retained hardware around the hip that precludes either study treatment.\n* Infection around the hip (soft tissue or bone).\n* Pathologic fracture with a lytic lesion in the femoral neck that precludes internal fixation.\n* Injury did not occur within 21 days of screening.\n* Patient is too ill, in the judgment of the attending surgeon, for internal fixation.\n* Patient is too ill, in the judgment of the attending surgeon, for arthroplasty.","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles General Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Bloomington","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland, Baltimore - R Adams Cowley Shock Trauma Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Capital Region Health","city":"Largo","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Brigham","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Mississippi","city":"University","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's University Health System","city":"Allentown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health-Upstate","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Vermont","city":"Burlington","state":"Vermont","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inova Health Care Services","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin - Madison","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of British Columbia","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fraser Health Authority","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"London Health Sciences Centre","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital","city":"Ottawa","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sykehuset Østfold HF / Østfold Hospital Trust","city":"Grålum","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Mutua de Terrassa","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consorci Sanitari de l'Alt Penedès i Garraf (CSAPG)","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"FRCB-IDIBAPS (Hospital Clinic Barcelona)","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Edinburgh","city":"Edinburgh","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joseph Patterson, MD","phone":"+13234426984","email":"OrthoTraumaResearch@med.usc.edu"}],"primaryOutcomes":["Composite outcome of death, ambulation status, and days alive and out of hospital."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["irvine-california","los-angeles-california","san-francisco-california","miami-florida","bloomington-indiana","baltimore-maryland","largo-maryland","boston-massachusetts","university-mississippi","new-york-new-york","cincinnati-ohio","oklahoma-city-oklahoma","allentown-pennsylvania","greenville-south-carolina","nashville-tennessee","salt-lake-city-utah","burlington-vermont","fairfax-virginia","madison-wisconsin","vancouver-canada","london-canada","ottawa-canada","gr-lum-norway","barcelona-spain","edinburgh-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Hip arthroplasty for Femoral Neck Fractures","inPlainEnglish":"This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial. The primary goal of this pragmatic, randomly assigned, open-label, comparative effectiveness trial is to evaluate if arthroplasty is superior to internal fixation when used to treat minimally displaced femoral neck fractures in older adults ≥60 years old.","whoItsFor":["Ages 60 Years to any","60 years of age or older undergoing surgery due to a minimally displaced femoral neck fracture","The patient has a health condition affecting physical mobility","Complete fracture of the femoral neck (AO/OTA 31B) confirmed with anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging","Minimally displaced fracture that could be, in the judgment of the attending surgeon, managed with either arthroplasty or in situ internal fixation without reduction","Low energy injury mechanism","Surgeons with expertise in internal fixation and total hip arthroplasty or hemiarthroplasty are available to perform surgery"],"whoShouldSkip":["The patient is not clinically suitable for either compared treatment","Expected injury survival of less than 12 months","Terminal illness with expected survival of less than 12 months","Problems, in the judgment of the study personnel, with maintaining follow-up with the patient","Currently enrolled in a study or intervention domain that does not permit co-enrollment","Prior enrollment in the specific platform trial intervention domain","Eligible patient or legally authorized representative was not approached within the screening window (missed participant)"],"whatHappens":"If you join, the listed intervention(s) are Hip arthroplasty, or Internal fixation. The registry lists allocation as randomized. This study is an intervention domain of the Musculoskeletal Adaptive Platform Trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 600 people at 32 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.415Z"},{"nctId":"NCT07246044","title":"HD-tDCS for Adolescent Bipolar Depression Targeting S1","officialTitle":"High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Jiangsu Province Nanjing Brain Hospital","sponsorClass":"OTHER","summary":"This randomized, double-blind, sham-controlled clinical trial aims to evaluate the efficacy and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. Participants will be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care. Biological data, including neuroimaging, blood biomarkers, voice and facial features, Photoplethysmography (PPG), Electroencephalography (EEG), and behavioral data, will be collected to explore potential predictors of treatment response.","conditions":["Adolescent","Bipolar Depression","tDCS","Primary Somatosensory Cortex","Bipolar Disorder Depression"],"keywords":["primary somatosensory cortex","adolescent","bipolar depression","high-definition transcranial direct current stimulation"],"interventions":[{"type":"DEVICE","name":"Active HD-tDCS"},{"type":"DRUG","name":"Antipsychotics, mood stabilizers, etc."},{"type":"DEVICE","name":"Sham HD-tDCS"}],"enrollment":100,"startDate":"2025-10-15","completionDate":"2027-12-31","sex":"ALL","minAge":"12 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Between 12 and 18 years of age;\n* Participants fulfill the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic criteria for bipolar disorder (BD). Participants are assessed by the Structured Clinical Interview for DSM-IV for Axis I Disorders (SCID-I, patients' age ≥18 years old), or the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K- SADS-PL, patients' age\\< 18 years old);\n* A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \\<12;\n* Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;\n* Participants and 1 or 2 parents (patients' age\\< 18 years old) provide informed consent after the detailed description of the study.\n\nExclusion Criteria:\n\n* Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;\n* Comorbidity of other DSM-IV axis I disorders or personality disorders;\n* Judged clinically to be at serious suicidal risk;\n* Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;\n* Unstable medical conditions, e.g., severe asthma;\n* Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;\n* Mental retardation or autism spectrum disorder;\n* Contraindications to MRI (e.g., severe claustrophobia, pacemakers, metal implants);\n* Contraindications to tDCS (e.g., metal in head, history of seizure, EEG test suggesting high risk of seizure, known brain lesion);\n* Current drug/alcohol abuse or dependence;\n* Pregnant or lactating female.","locations":[{"facility":"Affiliated Nanjing Brain Hospital, Nanjing Medical University","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lifei Wang","phone":"86-13390599200","email":"lifeiwang@stu.njmu.edu.cn"},{"name":"Jia Duan","phone":"86-025-83295957","email":"jia_duan@yeah.net"}],"primaryOutcomes":["Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2."],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["nanjing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Antipsychotics, mood stabilizers, etc. for Adolescent","inPlainEnglish":"This randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled clinical trial aims to measure the how well it works and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression. you would be randomly assigned to receive either active HD-tDCS or sham stimulation, in addition to routine clinical care.","whoItsFor":["Ages 12 Years to 18 Years","Between 12 and 18 years of age;","A current moderate or severe depressive episode defined by HAMD≥17 and Young Mania Rating Scale (YMRS) \\<12;","Participants receive a stable psychotropic medication regimen prior to randomization to the trial and are willing to remain on the stable regimen during the HD-tDCS treatment phase;"],"whoShouldSkip":["Prior rTMS or tDCS or electroconvulsive therapy (ECT) treatment or standard psychological therapy within 6 months prior to screening;","Comorbidity of other DSM-IV axis I disorders or personality disorders;","Judged clinically to be at serious suicidal risk;","Diabetes mellitus, hypertension, vascular and infectious diseases and other major medical comorbidities;","Unstable medical conditions, e.g., severe asthma;","Neurological disorders, e.g., history of head injury with loss of consciousness for ≥ five minutes, cerebrovascular diseases, brain tumors and neurodegenerative diseases;","Mental retardation or autism spectrum disorder;"],"whatHappens":"If you join, the listed intervention(s) are Active HD-tDCS, Antipsychotics, mood stabilizers, etc., or Sham HD-tDCS. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled clinical trial aims to measure the how well it works and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Nanjing. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.734Z"},{"nctId":"NCT07249216","title":"Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to Vascular Endothelial Growth Factor (VEGF) Inhibition in Neovascular Age-related Macular Degeneration (nAMD) Within a Clinical Trial Setting","officialTitle":"Identification of Molecular Signals in Vitreous Humor Associated With Suboptimal Response to VEGF Inhibition in nAMD Within a Clinical Trial Setting","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Singapore National Eye Centre","sponsorClass":"OTHER_GOV","summary":"Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss. While anti-VEGF (anti Vascular Endothelial Growth Factor) treatments such as ranibizumab help many patients, about 20 40% have a suboptimal response. In this study, the investigators want to identify other factors (beyond VEGF) that might be driving the disease in these non-responding patients. By looking at samples from inside the eye (vitreous humor) and comparing \"good responders\" to \"suboptimal responders\", the investigators hope to find potential new treatment approaches or biomarkers for nAMD.","conditions":["Age Related Macular Degeneration"],"keywords":[],"interventions":[{"type":"DRUG","name":"Faricimab"},{"type":"DRUG","name":"Ranibizumab"}],"enrollment":117,"startDate":"2025-07-18","completionDate":"2029-06","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients aged ≥ 50 years old at the time of informed consent\n2. Willing and able to provide informed consent\n3. Willingness and ability to comply with all scheduled visits and study procedures\n4. Female subjects must be of non-childbearing potential or show a negative pregnancy test at screening and must agree to use appropriate methods of contraception during the study and for one month after the last dose.\n5. Confirmed diagnosis of symptomatic nAMD based on optical coherence tomography (OCT), fluorescein fundus angiography (FFA), and indocyanine green angiography (ICG-A)\n6. nAMD characteristics:\n\n   1. Subfoveal CNV/PCV\n   2. Juxtafoveal/extrafoveal CNV/PCV with a subfoveal component related to the exudative activity.\n7. Either:\n\n   1. Treatment naïve- NO previous treatment with intravitreal anti-VEGF agents, regardless of the indication, NO previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication.\n   2. Eyes that have received 3 prior monthly intravitreal ranibizumab injections within 3 months prior to enrolment for nAMD indication only; and no previous treatment with other intravitreal anti-VEGF agents, no previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication.\n8. BCVA of 24-78 letters as measured by an Early Treatment Diabetic Retinopathy Study (ETDRS) chart (Snellen equivalent 20/32-20/320)\n\nExclusion Criteria:\n\n1. CNV or retinal exudation due to causes other than typical AMD, such as vitelliform dystrophy, ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis\n2. Active intraocular inflammation or suspected or active intraocular or periocular infection (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline\n3. Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that, in the judgment of the Investigator, could either require medical or surgical intervention during the course of the study to prevent or treat visual loss that might result from that condition or that limits the potential to gain visual acuity upon treatment with the investigational product\n\n   * History of cataract surgery within 6 months prior to recruitment\n   * Cataract surgery during the study period is not permitted.\n4. Retinal pigment epithelium (RPE) rip/tear in the study eye at Baseline\n5. Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline\n6. History of rhegmatogenous retinal detachment, stage 3/4 macular hole, or any retinal break unless adequate repair has been performed\n7. History of the following in the study eye:\n\n   * Previous pars plana vitrectomy\n   * Previous photodynamic therapy (PDT)\n   * Intraocular or refractive surgery within the 6 months period prior to Baseline\n   * Previous penetrating keratoplasty or vitrectomy\n   * Previous pan retinal photocoagulation\n   * Previous submacular surgery or macular laser treatment\n8. Uncontrolled glaucoma or ocular hypertension in the study eye defined as intraocular pressure (IOP) \\> 25 mmHg on medication or according to the investigator's judgment at baseline\n9. Intra- or periocular use of corticosteroids in the study eye during the 6-month period prior to baseline:\n\n   1. Use of topical ocular corticosteroids in the study eye for 60 or more consecutive days within the 90-day period prior to baseline\n   2. Use of systemic corticosteroids for 30 or more consecutive days within the 90 days prior to baseline, with the exception of low stable doses of corticosteroids (defined as ≤10 mg prednisolone or equivalent dose used for 90 days or more). Inhaled, nasal or dermal steroids are also permitted\n10. Previous therapeutic radiation near the region of the study eye\n11. History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the investigator, would preclude scheduled study visits, completion of the study, or a safe administration of the investigational product\n12. History of hypersensitivity to any component of the test article or clinically relevant sensitivity to fluorescein dye (or indocyanine green), as assessed by the Investigator\n13. Participation in an investigational drug, biologic, or device study within 30 days or the duration of 5 half-lives of the investigational product (whichever is longer) prior to baseline Note: observational clinical studies solely involving over-the-counter vitamins, supplements, or diets are not exclusionary\n14. Systemic anti-vascular endothelial growth factor (VEGF) therapy within the 90-day period prior to baseline\n15. Stroke or myocardial infarction in the 90-day period prior to baseline\n16. Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg and/or diastolic value ≥ 100 mmHg at screening\n17. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the study period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections","locations":[{"facility":"Singapore National Eye Centre/Singapore Eye Research Institute","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gemmy Cheung","phone":"63227460","email":"gemmy.cheung.c.m@singhealth.com.sg"}],"primaryOutcomes":["Difference in vitreous biomarker concentrations between responders and non-responders"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["singapore-singapore"],"enrichment":{"headline":"Not a traditional drug phase: testing Faricimab for Age Related Macular Degeneration","inPlainEnglish":"Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss. While anti-VEGF (anti Vascular Endothelial Growth Factor) treatments such as ranibizumab help many patients, about 20 40% have a suboptimal response.","whoItsFor":["Ages 50 Years to any","Willingness and ability to comply with all scheduled visits and study procedures","Female subjects must be of non-childbearing potential or show a negative pregnancy test at screening and must agree to use appropriate methods of contraception during the study and for one month after the last dose","Confirmed diagnosis of symptomatic nAMD based on optical coherence tomography (OCT), fluorescein fundus angiography (FFA), and indocyanine green angiography (ICG-A)","nAMD characteristics:","Juxtafoveal/extrafoveal CNV/PCV with a subfoveal component related to the exudative activity","Treatment naïve- NO previous treatment with intravitreal anti-VEGF agents, regardless of the indication, NO previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication","BCVA of 24-78 letters as measured by an Early Treatment Diabetic Retinopathy Study (ETDRS) chart (Snellen equivalent 20/32-20/320)"],"whoShouldSkip":["CNV or retinal exudation due to causes other than typical AMD, such as vitelliform dystrophy, ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis","Active intraocular inflammation or suspected or active intraocular or periocular infection (eg, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at Baseline","History of cataract surgery within 6 months prior to recruitment","Cataract surgery during the study period is not permitted","Retinal pigment epithelium (RPE) rip/tear in the study eye at Baseline","Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline","History of rhegmatogenous retinal detachment, stage 3/4 macular hole, or any retinal break unless adequate repair has been performed"],"whatHappens":"If you join, the listed intervention(s) are Faricimab, or Ranibizumab. The registry lists allocation as randomized. Neovascular age-related macular degeneration (nAMD), also called wet AMD, can cause serious vision loss.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 117 people at Singapore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.130Z"},{"nctId":"NCT07249944","title":"Myofunctional Therapy for Children With OSA","officialTitle":"Myofunctional Therapy for Children With Obstructive Sleep Apnoea - a Multi-centre Randomised Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"Myofunctional therapy (MFT) has been proposed as an adjunctive therapy for obstructive sleep apnoea (OSA) in children.\n\nSome studies have reported improved sleep parameters and reduced oral breathing after MFT. However, the level of evidence in these studies is limited, with most being case series or case-control studies. There have been only a few randomised controlled trials (RCTs), and these studies have had limitations such as low response rate, short follow-up periods, and the existing evidence does not adequately address the potential clinical benefits and the impact on craniofacial structure. Additionally, there is a lack of evidence regarding the effectiveness of additional measures, such as remote guidance and supervision, in improving treatment outcomes in children. Therefore, there is a need for further research to address these gaps and provide more robust evidence on the efficacy of MFT in children with OSA. The objective of this study is to investigate the efficacy of MFT in children with OSA through a multi-centre randomised controlled trial (RCT). 174 children aged 6-12 years old with OSA will be recruited and randomly assigned to either the intervention or control group. All children will undergo standardised evaluation at baseline and follow-up visits. In the intervention arm, a 24-week myofunctional therapy targeting orofacial MFT, breathing, and postural re-education, with incorporation of telemedicine for remote training and monitoring. In the control arm, children will receive standard care without MFT. The primary outcome measure will be obstructive apnoea hypopnoea index measured by polysomnography. Secondary outcome measures will be the oral breathing pattern, OSA-related symptoms, and quality of life. The treatment effect on outcomes will be examined using a mixed-effects model with an intention-to-treat approach. Subgroup analyses will explore potential effect modification by important participant characteristics, such as OSA severity and compliance. This study will generate evidence-based information regarding the efficacy of MFT in children with OSA and will inform clinical practice.","conditions":["Obstructive Sleep Apnea (OSA)"],"keywords":["Children","Obstructive sleep apnoea","Myofunctional therapy","Randomised controlled trial","Intervention"],"interventions":[{"type":"BEHAVIORAL","name":"Myofunctional therapy"}],"enrollment":174,"startDate":"2025-12-01","completionDate":"2028-12-31","sex":"ALL","minAge":"6 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Children aged 6-12 years, with this age range, children start to have a greater ability to understand and follow instructions, making them more likely to comply and cooperate with the treatment procedures, and at the same time this age range remains a critical and modifiable developmental window when interventions can address underlying orofacial muscle and respiratory muscle dysfunctions and enhance the potential for long-term benefits.\n2. Diagnosed with OSA based on clinical evaluation and polysomnography (oAHI ≥ 1/hour). The clinical evaluation will involve assessing the presence of habitual snoring, which is defined as snoring occurring 3 nights or more per week on average as reported by parents or caregivers, and any of the following features suggestive of SDB such as oral breathing, respiratory pauses, observed apnoeas, or increased work of breathing during sleep. Children with persistent OSA, documented by repeat PSG, can be included after receiving standard treatments (such as adenotonsillectomy treatment).\n3. Informed consent from a parent or a legal guardian.\n\nExclusion Criteria:\n\n* Genetic, syndromal, or metabolic disease\n* Congenital or acquired neuromuscular disease\n* Syndromal craniofacial abnormalities or previous craniofacial surgery\n* Severe developmental delay (developmental or functional age \\<66% of chronological age)\n* Children with OSA who are indicated for and will receive other treatments such as adenotonsillectomy, positive airway pressure therapy or orthodontic treatment.","locations":[{"facility":"Prince of Wales Hospital, The Chinese University of Hong Kong","city":"Shatin","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ching Ching, Kate CHAN, MD","phone":"(852) 3505 3515","email":"katechan@cuhk.edu.hk"}],"primaryOutcomes":["oAHI measured by PSG"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["shatin-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: Myofunctional therapy for Obstructive Sleep Apnea (OSA)","inPlainEnglish":"Myofunctional therapy (MFT) has been proposed as an added on top of your current treatment therapy for obstructive sleep apnoea (OSA) in children. Some studies have reported improved sleep parameters and reduced oral breathing after MFT.","whoItsFor":["Ages 6 Years to 12 Years"],"whoShouldSkip":["Genetic, syndromal, or metabolic disease","Congenital or acquired neuromuscular disease","Syndromal craniofacial abnormalities or previous craniofacial surgery","Severe developmental delay (developmental or functional age \\<66% of chronological age)","Children with OSA who are indicated for and will receive other treatments such as adenotonsillectomy, positive airway pressure therapy or orthodontic treatment"],"whatHappens":"If you join, the listed intervention(s) are Myofunctional therapy. The registry lists allocation as randomized. Myofunctional therapy (MFT) has been proposed as an added on top of your current treatment therapy for obstructive sleep apnoea (OSA) in children.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 174 people at Shatin. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.946Z"},{"nctId":"NCT07250269","title":"Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants With Relapsed or Refractory AL Amyloidosis","officialTitle":"A Phase 1b Study of GC012F, a Chimeric Antigen Receptor T Cell Therapy Targeting CD19 and B-cell Maturation Antigen in Chinese Participants With Relapsed or Refractory AL Amyloidosis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Gracell Biotechnologies (Shanghai) Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1b open-label, multicenter, non-randomized study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.","conditions":["Relapsed/Refractory AL Amyloidosis"],"keywords":["AZD0120","GC012F","Amyloidosis","AL Amyloidosis","CAR-T","Cell Therapy"],"interventions":[{"type":"DRUG","name":"GC012F Injection"}],"enrollment":12,"startDate":"2025-10-29","completionDate":"2028-11-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Confirmed histopathological diagnosis of AL amyloidosis\n2. One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines\n3. Measurable hematologic disease: dFLC \\> 20 mg/L or serum M-protein \\> 5g/L\n4. Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy.\n5. ECOG performance status of 0 to 1\n6. Must be able and willing to adhere to the study visit schedule and other protocol requirements\n7. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study.\n\nExclusion Criteria:\n\n1. Have any other form of amyloidosis other than AL amyloidosis\n2. Mayo Stage IIIb AL amyloidosis\n3. Oxygen saturation \\< 95% on room air\n4. Systolic blood pressure \\<100mmHg\n5. Cardiac exclusion criteria:\n\n   1. Mayo Stage IIIb AL amyloidosis as defined by\n\n      \\- NT-proBNP\\>8500ng/L, and\n      * high sensitivity cardiac troponin T ≥ 50 ng/L cardiac Troponin T ≥ 0.035 ng/mL or cardiac Troponin I ≥ 0.1 ng/mL\n   2. NT-proBNP levels as follows:\n\n      \\- NT-proBNP ≥ 2000 ng/L (for dose escalation portion)\n      * NT-proBNP \\< 2000 and \\> 8500 ng/L (for dose extension portion)\n   3. NYHA class III or IV\n\n5\\. Extensive GI involvement with evidence of active GI bleeding/risk of bleeding as determined by Investigator 6. Prior therapies:\n\n1. CAR T cell therapy directed at any target\n2. Prior BCMA-targeting therapy\n3. Prior treatment with any approved or investigational T cell engaging therapies (including T cell-directed bispecific or trispecific therapies) at any target within the last 6 months.\n\n7\\. Toxicity from previous anti-cancer or anti-PC-directed therapy did not resolve to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.\n\n8\\. Active plasma cell leukemia at the time of screening 9. Multiple myeloma defined as clonal bone marrow PCs ≥10% and any one or more of the following myeloma defining events (deemed as attributable to multiple myeloma by Investigator) 10. Seropositive for HIV 11. Serologic status reflecting active hepatitis B or C:\n\n1. Positive HBsAg, or\n2. Patients with positive core antibody (anti-HBc) and HBV-DNA positive.\n3. Patients with positive hepatitis C antibody and HCV RNA positive.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changchun","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Suzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wenzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Number of Participants With incidence and severity of Treatment-emergent Adverse Events","Number of participants with dose-limiting toxicities during dose escalation phase"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["car-t"],"locationSlugs":["beijing-china","changchun-china","guangzhou-china","hangzhou-china","suzhou-china","wenzhou-china","wuhan-china"],"enrichment":{"headline":"Phase 1: testing GC012F Injection for Relapsed/Refractory AL Amyloidosis","inPlainEnglish":"This is a Phase 1b open-label, multicenter, non-randomly assigned study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.","whoItsFor":["Ages 18 Years to any","Confirmed histopathological diagnosis of AL amyloidosis","One or more organs currently or historically impacted by AL amyloidosis according to consensus guidelines","Measurable hematologic disease: dFLC \\> 20 mg/L or serum M-protein \\> 5g/L","Relapsed disease or refractory disease defined as a need for additional therapy after at least 1 line of anti-plasma cell-directed therapy","how well you can do daily activities (ECOG score) of 0 to 1","Must be able and willing to adhere to the study visit schedule and other protocol requirements","Women of child-bearing potential (WCBP) must have a negative serum pregnancy test prior to treatment. All sexually active WCBP and all sexually active male subjects must agree to use effective methods of birth control throughout the study"],"whoShouldSkip":["Have any other form of amyloidosis other than AL amyloidosis","Mayo Stage IIIb AL amyloidosis","Oxygen saturation \\< 95% on room air","Systolic blood pressure \\<100mmHg"],"whatHappens":"If you join, the listed intervention(s) are GC012F Injection. The registry lists allocation as randomized. This is a Phase 1b open-label, multicenter, non-randomly assigned study of GC012F, a CD19/BCMA dual CAR T cell therapy, in adult participants with relapsed/refractory AL amyloidosis.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.402Z"},{"nctId":"NCT07252739","title":"KEYMAKER-U01 Substudy 01J: A Study of Pembrolizumab Plus MK-1084 in Participants With Non-Small Cell Lung Cancer (NSCLC) With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) G12C Mutations (MK-3475-01J/KEYMAKER-U01J)","officialTitle":"KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change. The goal of this study is to learn about the safety of MK-1084 and to learn how many people have the cancer get smaller or go away during the study treatment.","conditions":["Malignant Neoplasm"],"keywords":["Programmed Cell Death-1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)"],"interventions":[{"type":"DRUG","name":"MK-1084"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"BIOLOGICAL","name":"Cetuximab"},{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan (sac-TMT)"},{"type":"DRUG","name":"Rescue medication"}],"enrollment":140,"startDate":"2025-12-19","completionDate":"2029-11-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)\n* Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations\n* Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated\n* Has recovered to ≤Grade 1 or baseline from any Adverse events (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement\n* Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected\n* Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive\n* Has undetectable hepatitis C (HCV) viral load if HCV-infected\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements\n* Has HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease\n* Has uncontrolled, clinically significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of corrected QT interval corrected for heart rate by Fridericia's formula (QTcF) interval to \\>470 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention\n* Has received prior systemic anticancer therapy for advanced or metastatic NSCLC\n* Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis\n* Has received previous treatment with an agent targeting KRAS\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from AE associated with anticancer therapy before allocation/randomization\n* Has received radiation therapy to the lung that is \\>30 Gray within 6 months of start of study intervention\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening\n* Has a history of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","locations":[{"facility":"Clermont Oncology Center ( Site 0041)","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Health Roger Maris Cancer Center ( Site 0039)","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Cancer Center Oncology Clinic ( Site 0038)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Arturo Lopez Perez ( Site 0167)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oncología de Precisión ( Site 0160)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill ( Site 0168)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0318)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0306)","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital Fudan University ( Site 0319)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University ( Site 0315)","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kuopion Yliopistollinen Sairaala ( Site 0261)","city":"Kuopio","state":"Northern Savonia","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vaasan Keskussairaala ( Site 0263)","city":"Vaasa","state":"Pohjanmaa","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Turku University Hospital ( Site 0262)","city":"Turku","state":"Southwest Finland","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"HYKS Syöpätautien klinikka ( Site 0260)","city":"Helsinki","state":"Uusimaa","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelismos General Hospital of Athens ( Site 0200)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hong Kong Integrated Oncology Centre ( Site 0232)","city":"Central","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Mary Hospital ( Site 0230)","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hong Kong United Oncology Centre ( Site 0231)","city":"Kowloon","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0175)","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deventer Ziekenhuis ( Site 0272)","city":"Deventer","state":"Overijssel","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leids Universitair Medisch Centrum ( Site 0273)","city":"Leiden","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0151)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital Yonsei University Health System ( Site 0080)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Macarena ( Site 0093)","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 0351)","city":"Bangkok","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine Siriraj Hospital ( Site 0350)","city":"Bangkok","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erciyes University ( Site 0145)","city":"Talas","state":"Kayseri","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baskent University Dr. Turgut Noyan Research and Training Center ( Site 0141)","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koç Üniversitesi Hastanesi ( Site 0142)","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liv Hospital Ankara ( Site 0146)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri ( Site 0140)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0139)","city":"Cherkasy","state":"Cherkasy Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center \"Mriya Med-Service\"-Clinical Research Department ( Site 0465)","city":"Kryvyi Rih","state":"Dnipropetrovsk Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Non-Commercial Enterprise \"Prykarpatski Clinical On-Surgery department #2 ( Site 0132)","city":"Ivano-Frankivsk","state":"Ivano-Frankivsk Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 0467)","city":"Kropyvnytskyi","state":"Kirovohrad Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lviv Territorial Medical Union Multidisciplinary Clinical Hospital ( Site 0133)","city":"Lviv","state":"Lviv Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Noncommercial Enterprise \"Podillia Regional Oncolog-Cardiothoracic department ( Site 0131)","city":"Vinnitsya","state":"Vinnytsia Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uzhhorod Municipal Multidisciplinary Clinical Hospital of Uzhhorod City Council ( Site 0137)","city":"Uzhhorod","state":"Zakarpattia Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"VISION PARTNER Medical Centre ( Site 0135)","city":"Kyiv","state":"","country":"Ukraine","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"LLC \"MEDICAL CENTER DOBROBUT-CLINIC\" ( Site 0138)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Percentage of Participants with a Dose Limiting Toxicity (DLT)","Percentage of Participants who Experience at Least One Adverse Event (AE)","Percentage of Participants who Discontinue Study Intervention Due to an AE","Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 as assessed by Blinded Independent Central Review (BICR)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["clermont-florida","fargo-north-dakota","sioux-falls-south-dakota","santiago-chile","nanjing-china","nanchang-china","shanghai-china","chengdu-china","kuopio-finland","vaasa-finland","turku-finland","helsinki-finland","athens-greece","central-hong-kong","hong-kong-hong-kong","kowloon-hong-kong","milan-italy","deventer-netherlands","leiden-netherlands","warsaw-poland","seoul-south-korea","seville-spain","bangkok-thailand","talas-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","cherkasy-ukraine","kryvyi-rih-ukraine","ivano-frankivsk-ukraine","kropyvnytskyi-ukraine","lviv-ukraine","vinnitsya-ukraine","uzhhorod-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 2: testing MK-1084 for Malignant Neoplasm","inPlainEnglish":"Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC). MK-1084 is a type of treatment called targeted therapy for the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C gene change.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has histologically or cytologically confirmed diagnosis of advanced or metastatic nonsquamous Non-Small Cell Lung Cancer (NSCLC)","Has tumor tissue or circulating tumor deoxyribonucleic acid (ctDNA) that demonstrates the presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutations","Can provide an archival tumor tissue sample or newly obtained core, incisional, excisional biopsy of a tumor lesion not previously irradiated","Has recovered to ≤Grade 1 or baseline from any side effects (AEs) due to previous anticancer therapies and/or ≤Grade 2 neuropathy and/or endocrine-related AEs adequately treated with hormone replacement","Has well controlled human immunodeficiency virus (HIV) on antiretroviral therapy (ART) if HIV-infected","Has undetectable hepatitis B (HBV) viral load and have received HBV antiviral therapy for at least 4 weeks if hepatitis B surface antigen (HBsAg) positive"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-1084, Pembrolizumab, or Cetuximab. The registry lists allocation as randomized. Researchers want to learn if using a study medicine called MK-1084 can help treat Non-Small Cell Lung Cancer (NSCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 140 people at 40 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.723Z"},{"nctId":"NCT07258745","title":"Pharmacokinetic, Safety, Tolerability, and Immunogenicity Comparison of CKD-704 (Risankizumab Biosimilar), With EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants","officialTitle":"A Randomized, Double-Blind, Single-Dose, Parallel-Group, Three-Arm Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Profiles of CKD-704 (Risankizumab Biosimilar), EU-approved Skyrizi®, and US-licensed Skyrizi® in Healthy Adult Participants","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Chong Kun Dang Pharmaceutical","sponsorClass":"INDUSTRY","summary":"This is a Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.","conditions":["Psoriasis"],"keywords":["Psoriasis"],"interventions":[{"type":"BIOLOGICAL","name":"SKYRIZI"},{"type":"BIOLOGICAL","name":"SKYRIZI"},{"type":"BIOLOGICAL","name":"CKD-704"}],"enrollment":213,"startDate":"2025-11-26","completionDate":"2026-09-30","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Capability of giving signed informed consent and complying with the requirements and restrictions listed in the ICF and Protocol\n* Healthy male or female, 18 to 55 years (inclusive) at the time of signing the ICF\n* smokes ≤ 10 cigarettes per week within 3 months of screening\n* abstain from alcohol from 48 hours prior to study intervention administration and keeping alcohol consumption within WHO limits (more than 14 units per week spread over 3 or more days, equivalent to 6 pints of average strength beer or 6 medium glasses \\[175 mL\\] of wine)\n* have acceptable venous access for blood collection\n* Female participants are eligible to participate if they are not pregnant, not breastfeeding\n* Male participants must refrain from donating sperm from screening (signing the ICF) until at least 30 days after EOS visit\n* All participants must be willing to use effective/highly effective methods of contraception during the study period\n* Participants are willing and able to be confined to the clinical unit prior to and during the study intervention administration and required follow-up periods.\n\nExclusion Criteria:\n\n* History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment\n* History of relevant drug and/or food allergies\n* History of hypersensitivity to Skyrizi or their constituents\n* Presence of psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures\n* Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to participant safety\n* Major surgery within 12 weeks prior to the randomization into the study\n* Documented active or suspected malignancy or history of malignancy within 5 years prior to screening\n* Positive tests for hepatitis B surface antigen, Hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening\n* Positive test for severe acute respiratory syndrome coronavirus 2 on admission (optional)\n* Any current active infections or any recent history (within 1 week prior to study intervention administration) of active infections\n* Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis\n* Abnormal hepatic, renal, or hematological laboratory tests. In such cases, the assessment may be repeated once at screening and admission. The Investigator will check reassessment results to decide if the value is clinically significant and if participant is eligible to receive the treatment\n* Any other laboratory value outside the reference range that the Investigator considers to be of clinical significance\n* Abnormal vital signs(Systolic blood pressure \\< 90 mmHg or \\> 140 mmHg, Diastolic blood pressure \\< 50 mmHg or \\> 90 mmHg, Heart rate \\< 45 or \\> 100 beats per minute)\n* Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG\n* Any past or concurrent medical conditions, or clinically important active infection that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion\n* Have used any prescription or non-prescription medicines or vitamins within 7 days or 5 half-lives (whichever is longer) of admission, unless in the Investigator's opinion will not affect determination of safety or other study assessments\n* Male or females participating in any other clinical trial at the time of consenting\n* Have received any investigational drug within 30 days prior to screening, with minimal washout of at least 5-half-lives of any previous investigational drug, whichever is longer\n* Have received live vaccines during the past 4 weeks before screening or have the intention to receive vaccination during the 21-week treatment and assessment period\n* Participant has donated blood (\\> 500 mL) or blood products within 2 months (56 days) prior to screening\n* History of drug abuse or alcohol abuse as judged by the Investigator or designee\n* Participant is affiliated with the site or Sponsor and/or may be considered to be consenting under duress\n* Participant is unlikely to co-operate with the requirements of the study","locations":[{"facility":"MTZ powered by Pratia","city":"Warsaw","state":"Warszawa","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Dryja, MD","phone":"+48 22 572 59 59","email":"anna.dryja@pratia.com"}],"primaryOutcomes":["Maximum Observed Serum Concentration (Cmax)","AUC From Time 0 to Infinity (AUCinf)"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":["risankizumab"],"locationSlugs":["warsaw-poland"],"enrichment":{"headline":"Phase 1: testing SKYRIZI for Psoriasis","inPlainEnglish":"This is a Phase 1, first-in-human (FIH), randomly assigned, neither you nor the study doctors know who gets the real treatment, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.","whoItsFor":["Ages 18 Years to 55 Years","Healthy male or female, 18 to 55 years (inclusive) at the time of signing the ICF","smokes ≤ 10 cigarettes per week within 3 months of screening","abstain from alcohol from 48 hours prior to study intervention administration and keeping alcohol consumption within WHO limits (more than 14 units per week spread over 3 or more days, equivalent to 6 pints of average strength beer or 6 medium glasses \\[175 mL\\] of wine)","have acceptable venous access for blood collection","Female participants are eligible to participate if they are not pregnant, not breastfeeding","Male participants must refrain from donating sperm from screening (signing the ICF) until at least 30 days after EOS visit","All participants must be willing to use effective/highly effective methods of contraception during the study period"],"whoShouldSkip":["History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment","History of relevant drug and/or food allergies","History of hypersensitivity to Skyrizi or their constituents","Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to participant safety","Major surgery within 12 weeks prior to the randomization into the study","Documented active or suspected malignancy or history of malignancy within 5 years prior to screening","Positive tests for hepatitis B surface antigen, Hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening"],"whatHappens":"If you join, the listed intervention(s) are SKYRIZI, SKYRIZI, or CKD-704. The registry lists allocation as randomized. This is a Phase 1, first-in-human (FIH), randomly assigned, neither you nor the study doctors know who gets the real treatment, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 213 people at Warsaw. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.585Z"},{"nctId":"NCT07262983","title":"Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis","officialTitle":"A Pilot Study to Evaluate the Safety and Tolerability of Baricitinib in Patients With Job s Syndrome With Lupus-like Disease and/or Atopic Dermatitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","sponsorClass":"NIH","summary":"Background:\n\nAutosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones. People with HIES often have lupus-like disease or atopic dermatitis (skin rash). Researchers want to know if a drug approved to treat other immune system diseases (baricitinib) can help people with HIES.\n\nObjective:\n\nTo test baricitinib in people with HIES with lupus-like disease or skin rash.\n\nEligibility:\n\nPeople aged 12 years and older with HIES with lupus-like disease or skin rash.\n\nDesign:\n\nParticipants will have 5 clinic visits, 4 remote visits, and 2 phone visits in 9 months.\n\nParticipants will be screened. They will have a physical exam with blood and urine tests. They will have tests of the speed and pressure of blood flow through their body: Blood pressure cuffs will be placed on each arm and leg; electrodes will be placed on the wrists and a microphone on the chest.\n\nThe study has a 3-month lead-in period. Participants will not take the study drug during this time. They will continue with their usual medical care. They will have 2 phone calls with the study team.\n\nBaricitinib is a tablet taken by mouth. Participants will take 1 or 2 tablets by mouth every day for 6 months. They will start with a low dose and may increase to a higher dose.\n\nBlood and urine tests will be repeated during each study visit. Other tests may also be repeated during some visits. A skin sample may also be taken....","conditions":["Hyper IgE Syndrome From STAT3 Mutation","Job s Syndrome","HIES","Lupus","Atopic Dermatitis"],"keywords":["Hyper IgE Syndrome From STAT3 Mutation","Job s syndrome","HIES","Lupus","Atopic Dermatitis","Lupus-like Disease","JAK Inhibition","Janus Kinases"],"interventions":[{"type":"DRUG","name":"baricitinib"}],"enrollment":20,"startDate":"2026-11-15","completionDate":"2030-05-01","sex":"ALL","minAge":"12 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Must be able to understand and provide informed consent or assent.\n2. Aged \\>=12 years.\n3. Documented STAT3 variant causing hyper-IgE syndrome.\n4. Enrollment in NIH protocol 00-I-0159, Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES).\n\n   a. Presence of SLE and/or AD as follows: SLE patients should meet either Systemic Lupus International Collaborating Clinics (SLICC) or 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE classification criteria. AD is defined as EASI tool score \\>=16 and body surface area tool score of 10% at screening.\n5. Ability to take oral medication and be willing to adhere to the study intervention regimen.\n6. For individuals on glucocorticoids, the dose must be less than 10 mg daily and stable for the 30 days prior to Day 0.\n7. For individuals on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for 90 days prior to Day 0. The maximum allowed dose is hydroxychloroquine 400 mg/day or 6.5 mg/kg/day, whichever is greater. The maximum allowed dose for chloroquine phosphate is 500 mg daily, and for quinacrine is 100 mg daily.\n8. Individuals may be on lipid-lowering medications if initiated at least 90 days prior to Day 0, and the dose must be stable for 30 days prior to Day 0.\n9. Individuals of reproductive potential must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy while on study drug. Acceptable methods of contraception include:\n\n   * Intrauterine device (IUD)\n   * Bilateral tubal ligation\n   * Abstinence\n   * Vasectomized partner\n   * Hormonal contraception used in combination with barrier method: progestogen containing (oral, intravaginal, transdermal) or progestogen-only (oral, injectable, implantable) starting 30 days prior to initiation of baricitinib\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Known history of hypersensitivity to baricitinib or other JAK inhibitors.\n2. Current or recent use of any investigational drug/intervention (within 6 months or 5 half-lives, whichever is longer, prior to Day 0) except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.\n3. Scheduled to participate in another clinical study involving an investigational drug during the course of this study.\n4. Use of systemic immunosuppressive or immune-modulating agents within 90 days prior to Day 0, except systemic steroids \\<=10 mg of prednisone equivalent per day.\n5. Current or prior treatment with rituximab in the 6 months prior to Day 0.\n6. Current treatment with methotrexate, mycophenolate mofetil, other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), belimumab, and other immunosuppressive biologics not otherwise specified herein. Participants previously on methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or belimumab, other immunosuppressive biologics, or DMARDs should have been withdrawn from the drug for at least 90 days prior to Day 0.\n7. Treatment with cyclophosphamide and pulse methylprednisolone within 6 months prior to Day 0.\n8. Hypercholesterolemia: Values after 8- to 12-hour fasting blood specimen: total cholesterol \\>250 mg/dL or LDL \\>180 mg/dL or hypertriglyceridemia (triglyceride \\>300 mg/dL) within 90 days prior to Day 0.\n9. History of alcohol or drug abuse within 6 months prior to Day 0.\n10. Presence of 1 or more of the following clinically significant laboratory abnormalities:\n\n    1. Serum ALT \\>=3 times ULN.\n    2. Serum total bilirubin \\>=2 times ULN.\n    3. ANC \\<=750 cells/microL.\n    4. Hemoglobin \\<=9.0 g/dL.\n    5. Platelet count \\<=100,000/microL.\n    6. Serum creatinine \\>=2 times ULN.\n11. Planned or anticipated major surgical procedure during the study.\n12. Plans to receive any live vaccines within 1 month of the anticipated first dose of baricitinib.\n13. Known or suspected immune-dysregulatory disorders besides Job s syndrome, lupus-like disease, and/or AD.\n14. Active invasive opportunistic infections (eg, non-TB mycobacterial infections, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis) despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged infections suggesting an immune-compromised status as judged by the investigator.\n15. Known active TB. Participants with treated LTB will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease consultant and may become eligible for trial based on infectious disease consultant recommendations.\n16. Infection with HIV.\n17. Untreated infection with hepatitis B or C.\n18. Unwillingness to receive prophylactic entecavir (or similar), only for individuals with evidence of clearance of hepatitis B with positive hepatitis B core and surface antibody and negative hepatitis B surface antigen and PCR.\n19. BK or JC viremia at screening visit.\n20. Active infection that requires the use of oral or intravenous antimicrobials that remains unresolved at least 14 days prior to the administration of the first dose of study medication.\n21. Individuals with active renal or central nervous system disease or a high activity level in any organ system (except articular) that requires immediate immunosuppressive therapy as determined by the investigator.\n22. History of cancer, with the exceptions of basal cell carcinoma, localized squamous cell carcinoma of the skin, or in situ carcinoma of the cervix, provided the participant is in remission and curative therapy was completed at least 12 months prior to screening. History of other malignancies are also permitted provided that the individual is in remission and curative therapy was completed at least 5 years prior to screening.\n23. Planned or anticipated use of any prohibited medications and procedures during the study.\n24. Pregnancy or current breastfeeding.\n25. Currently receiving hemodialysis or peritoneal dialysis.\n26. Past or current medical problems or findings from physical examination, electrocardiogram, or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risk from participation in the study, may interfere with the individual s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. These may include, but are not limited to:\n\n    1. Known coronary artery aneurysm.\n    2. Known history of arterial or venous thrombosis or at high risk for clotting disorder.\n    3. Known history of PE or DVT in the past.\n    4. Psychiatric illness or history of medical non-compliance that the study team feels will make the individual unlikely to complete the study.\n    5. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the investigator, would jeopardize the individual s safety following exposure to the study drug.\n27. Individuals with known increased risk factors for MACE including a history of:\n\n    1. Ischemic heart disease (eg, history of acute myocardial infarction).\n    2. Heart failure.\n    3. Cardiomyopathy.\n    4. Severe valvular heart disease.\n    5. Significant arrhythmias.\n    6. Chronic renal failure.\n    7. Cerebrovascular accident or transient ischemic attack.\n    8. Uncontrolled diabetes mellitus.\n    9. Uncontrolled hypertension.\n    10. Current smokers or former smokers with less than 3 years since complete cessation and/or \\>20 pack-years of smoking history.\n28. History of idiopathic GI perforation or diverticulitis with high risk of perforation.\n29. Treatment with strong organic anion transporter 3 inhibitors (OAT3) (eg, probenecid) due to drug interactions.\n30. Uncontrolled thyroid disease as per principal investigator or medically responsible investigator.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alexandra F Freeman, M.D.","phone":"(301) 594-9045","email":"sarthak.gupta@nih.gov"}],"primaryOutcomes":["Incidence of SAEs, AEs requiring study drug discontinuation."],"hasResults":false,"conditionSlugs":["als","lupus","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing baricitinib for Hyper IgE Syndrome From STAT3 Mutation","inPlainEnglish":"Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones.","whoItsFor":["Ages 12 Years to 120 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Documented STAT3 variant causing hyper-IgE syndrome","Enrollment in NIH protocol 00-I-0159, Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)","Ability to take oral medication and be willing to adhere to the study intervention regimen","For individuals on glucocorticoids, the dose must be less than 10 mg daily and stable for the 30 days prior to Day 0","Individuals may be on lipid-lowering medications if initiated at least 90 days prior to Day 0, and the dose must be stable for 30 days prior to Day 0","Individuals of reproductive potential must agree to use at least one highly effective method of contraception when engaging in sexual activities that can result in pregnancy while on study drug. Acceptable methods of contraception include:"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Known history of hypersensitivity to baricitinib or other JAK inhibitors","Current or recent use of any investigational drug/intervention (within 6 months or 5 half-lives, whichever is longer, prior to Day 0) except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization","Scheduled to participate in another clinical study involving an investigational drug during the course of this study","Use of systemic immunosuppressive or immune-modulating agents within 90 days prior to Day 0, except systemic steroids \\<=10 mg of prednisone equivalent per day","Current or prior treatment with rituximab in the 6 months prior to Day 0","Treatment with cyclophosphamide and pulse methylprednisolone within 6 months prior to Day 0"],"whatHappens":"If you join, the listed intervention(s) are baricitinib. The registry lists allocation as na. Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.813Z"},{"nctId":"NCT07265570","title":"Study Evaluating ISM5411 Administered Orally to Subjects With Active Ulcerative Colitis (BETHESDA)","officialTitle":"A Phase IIa, Multicenter, Randomized, Double-blind, Placebo-controlled, Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of ISM5411 in Adult Patients With Active Ulcerative Colitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"InSilico Medicine Hong Kong Limited","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and clinical efficacy of ISM5411 in adult patients with active ulcerative colitis.","conditions":["Ulcerative Colitis"],"keywords":["Prolyl hydroxylase (PHD) inhibitor","Ulcerative colitis（UC）","Inflammatory bowel disease (IBD)"],"interventions":[{"type":"DRUG","name":"ISM5411 tablets"},{"type":"DRUG","name":"ISM5411 tablets"},{"type":"DRUG","name":"ISM5411 tablets"},{"type":"DRUG","name":"Placebo"}],"enrollment":80,"startDate":"2025-12-10","completionDate":"2027-08-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subject who fully understand the content, process and possible adverse events of the study and capable of giving written informed consent form (ICF).\n2. Female subjects must be nonpregnancy and nonlactating. Subjects (male or female) are willing to take medically approved effective contraceptive measures from the screening period to 3 months after the last administration and have no sperm or egg donation plan during the study period and within 3 months after the last dose.\n3. Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF.\n4. Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol.\n5. If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n6. If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled.\n\nExclusion Criteria:\n\n1. Subjects have suspected or diagnosed Crohn's disease (CD), undefined colitis, ischemic colitis, fulminant colitis, toxic megacolon, radiation colitis, gastrointestinal perforation (other than appendicitis or penetrating injury), diverticular disease associated with colitis, enterophthisis, abdominal abscess or fistula, etc.\n2. Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia.\n3. Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study.\n4. Subjects have evidence of a pathogenic intestinal infection, or have a Clostridium Difficile infection or other intestinal infection within 30 days prior to the screening endoscopy or have tested positive for Clostridium Difficile toxins or other intestinal pathogens at the screening period.\n5. Subjects have chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, make them an unsuitable candidate for the study.\n6. Subjects who are unable to take oral medications and/or have an impact on absorption of medication due to severe malnutrition or disease and surgery, etc., or who are currently receiving or plan to receive total parenteral nutrition (TPN) during the study period.\n7. Subjects who have received the relevant treatments defined in the protocol.\n8. Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection.\n9. Subjects who have the risks of tuberculosis defined in the protocol.\n10. Subjects have any of the infection defined in the protocol.\n11. Subjects who are known to be allergic to the investigational product or any components of it or who have allergic constitution (allergy to multiple drugs or foods).\n12. Subjects have unstable or uncontrolled and clinically significant allergic (except for untreated, asymptomatic, seasonal allergies), hematological, endocrine/metabolic, coagulation, immunologic, pulmonary, cardiovascular, hepatic (expect hepatic steatohepatitis), digestion system (expect UC), genitourinary, psychiatric, oncologic or neurological disease or other medical disorder that would make them ineligible for the study.\n13. Subjects have concomitant illness that in the opinion of the investigator, are likely to require systemic glucocorticosteroid therapy during the study (e.g., moderate to severe asthma).\n14. Subjects have received major organ surgery (except needle biopsy, tracheotomy, gastrotomy, etc.) or significant trauma within 28 days prior to randomization or is likely to require related surgery during the study.\n15. Subjects have history of any malignancy within 5 years of screening, except for successfully treated nonmelanoma skin cancer (NMSC), skin basal cell carcinoma, or localized carcinoma in situ of the cervix.\n16. Any abnormal results defined in the protocol were identified during the screening period.\n17. Subjects with poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) despite medication at screening.\n18. Subjects have a clinically significant abnormal ECG at screening, including QTcF \\> 450 msec for males and \\> 470 msec for females.\n19. Subjects have difficulty in venous blood collection or history of acupuncture syncope reaction or blood phobia.\n20. Subjects have contraindications to colonoscopy, including but not limited to gastrointestinal fistulas, early post abdominal surgery, severe coagulopathy, large abdominal aneurysms, or any condition that the investigator determines significantly increases the risk of colonoscopy complications.\n21. Subjects have a history of alcohol or drug abuse within 3 months of screening, according to the judgement of the investigator. Alcohol abuse refers to consuming alcohol at least twice per day or more than 14 units of alcohol per week.\n22. Subjects have participated in other clinical trials of other drugs or medical devices within 30 days prior to screening period and have already received the investigational product, or are currently participating in another clinical trial of a drug or medical device.\n23. Subjects are deemed by the investigator to be inappropriate for the study; or have any condition which would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or are unable or unwilling to comply with the study protocol.","locations":[{"facility":"Beijing Friendship Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangzhou First People's Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital,Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huizhou First Hospital","city":"Huizhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The People's Hospital of Guangxi Zhuang Autonomous Region","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of HeBei Medical University","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science & Technology","city":"Luoyang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xinxiang Medical University","city":"Xinxiang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renmin Hospital of Wuhan University","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Third Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of University of South China","city":"Hengyang","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"ZhongDa Hospital Southeast University","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Gannan Medical University","city":"Ganzhou","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Meihekou Central Hospital","city":"Tonghua","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengjing Hospital of China Medical University","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Binzhou Medical University Hospital","city":"Binzhou","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tai 'an City Central Hospital","city":"Taian","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Longhua Hospital Shanghai University of Traditional Chinese Medicine","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital, Shanghai Jiaotong University School of Medicine","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Hospital of Shanxi Medical University","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xi'an Central Hospital","city":"Xian","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Provincial People's Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China School of Medicine and West China Hospital Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin People's Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Kunming Medical University","city":"Kunming","state":"Yunnan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lishui Central Hospital","city":"Lishui","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yang Deng","phone":"+86 021-50831718","email":"Insilico-Clinicaltrial@insilico.ai"}],"primaryOutcomes":["The rate of treatment-emergent adverse events (TEAEs) in each group.","The rate of serious adverse events (SAEs) and adverse events (AEs) leading to discontinuation of treatment in each group.","Changes and comparisons of the following data for each group of subjects: vital signs, physical examination, laboratory test(blood routine, blood chemistry, urinalysis, coagulation function, etc.), ECG(Heart rate, RR, PR, QRS,QT, QTcF ), etc."],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["beijing-china","chongqing-china","guangzhou-china","huizhou-china","nanning-china","shijiazhuang-china","luoyang-china","xinxiang-china","wuhan-china","changsha-china","hengyang-china","nanjing-china","ganzhou-china","tonghua-china","shenyang-china","binzhou-china","taian-china","shanghai-china","taiyuan-china","xian-china","chengdu-china","tianjin-china","kunming-china","lishui-china","wenzhou-china"],"enrichment":{"headline":"Phase 2: testing ISM5411 tablets for Ulcerative Colitis","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the safety, tolerability, pharmacokinetics and clinical how well it works of ISM5411 in adult patients with active ulcerative colitis.","whoItsFor":["Ages 18 Years to 75 Years","Male or female between 18 and 75 years of age (inclusive), at the time of signing the ICF","Subject has a diagnosis of ulcerative colitis for at least 3 months prior to colonoscopy during the screening period, and meets the criteria defined in the current protocol","If the subjects have concomitant medication defined in the current protocol, they must meet the relevant criteria to be enrolled","If the subjects have discontinued medication defined in the current protocol, they must meet the relevant criteria to be enrolled"],"whoShouldSkip":["Subjects with previously diagnosed but uneradicated or current gastrointestinal dysplasia","Subjects have received surgery for UC or any other type of major intestinal surgery (i.e., surgical procedure requiring general anesthesia) or are likely to require related surgery during the study","Subjects have chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, make them an unsuitable candidate for the study","Subjects who are unable to take oral medications and/or have an impact on absorption of medication due to severe malnutrition or disease and surgery, etc., or who are currently receiving or plan to receive total parenteral nutrition (TPN) during the study period","Subjects who have received the relevant treatments defined in the protocol","Subjects with recurrent or disseminated (even if single episode) herpes zoster, or cytomegalovirus infection","Subjects who have the risks of tuberculosis defined in the protocol"],"whatHappens":"If you join, the listed intervention(s) are ISM5411 tablets, ISM5411 tablets, or ISM5411 tablets. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to measure the safety, tolerability, pharmacokinetics and clinical how well it works of ISM5411 in adult patients with active ulcerative colitis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.217Z"},{"nctId":"NCT07266831","title":"A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)","officialTitle":"A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV-1","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body. Standard ART helps people live longer, but people must take up to 3 medicines up to twice a day. Standard ART may also cause other health problems. Researchers want to know if a study ART works as well as a standard ART to treat HIV-1. The study ART combines 2 medicines, islatravir and ulonivirine, and is taken once a week. The goals of this study are to learn: 1) If the study ART works as well as a standard ART to treat HIV-1, and 2) About the safety of the study ART and if people tolerate it compared to a standard ART.","conditions":["Human Immunodeficiency Virus Type 1 (HIV-1) Infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"ISL"},{"type":"DRUG","name":"ULO"},{"type":"DRUG","name":"BIC/FTC/TAF"},{"type":"DRUG","name":"Placebo for BIC/FTC/TAF"},{"type":"DRUG","name":"Placebo to ISL/ULO"},{"type":"DRUG","name":"ISL/ULO"}],"enrollment":570,"startDate":"2025-12-18","completionDate":"2029-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL.\n* Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 and ≤1,000,000 copies/mL\n* Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\\^3.\n* Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection.\n\nExclusion Criteria:\n\n* Has human immunodeficiency virus type 2 (HIV-2) infection.\n* Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection.\n* Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection.\n* Has a history of malignancy ≤5 years prior to providing documented informed consent except for adequately treated basal cell or squamous cell skin cancer, in situ cervical or in situ anal cancer, or cutaneous Kaposi's sarcoma.\n* Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1.","locations":[{"facility":"Ruane Clinical Research Group, Inc. ( Site 1513)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vivent Health ( Site 1519)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Whitman-Walker Institute ( Site 1538)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midway Immunology and Research Center ( Site 1503)","city":"Ft. Pierce","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health- Miami Gardens ( Site 1549)","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Immunology Center ( Site 1501)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health ( Site 1510)","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triple O Research Institute ( Site 1505)","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Infectious Diseases Consultants L.L.C. ( Site 1509)","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercer university, Department of internal medicine-Clinical Research ( Site 1512)","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center-Infectious Disease ( Site 1522)","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital ( Site 1535)","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"KC CARE Health Center ( Site 1506)","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ID Care ( Site 1507)","city":"Hillsborough","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Infectious Disease Kenilworth - Charlotte ( Site 1533)","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regional Center for Infectious Diseases ( Site 1516)","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University ( Site 1536)","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania Perelman School of Medicine ( Site 1508)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Hope Foundation, Inc. ( Site 1504)","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prism Health North Texas, Oak Cliff Health Center ( Site 1514)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Texas Infectious Diseases Consultants ( Site 1500)","city":"Dallas","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Texas Center for Infectious Disease Associates ( Site 1502)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCOL Center for Clinical Research ( Site 1511)","city":"Longview","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harborview Medical Center ( Site 1526)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 3102)","city":"Caba","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Huesped ( Site 3100)","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clinicas Mar del Plata ( Site 3103)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación IDEAA ( Site 3101)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto CAICI SRL ( Site 3106)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 3105)","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Health ( Site 3307)","city":"Vancouver","state":"British Columbia","country":"Canada","status":"COMPLETED","lat":null,"lon":null},{"facility":"Gestion clinique médicale l'Actuel ( Site 3303)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biomedica Research Group ( Site 4201)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Universidad de Los Andes ( Site 4207)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Espacio Eme ( Site 4202)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Bordeaux University Hospital - Pellegrin ( Site 3605)","city":"Bordeaux","state":"Gironde","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Toulouse - Hôpital Purpan ( Site 3608)","city":"Toulouse","state":"Haute-Garonne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu-Infectious Disease ( Site 3606)","city":"Nantes","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOPITAL DE LA CROIX ROUSSE ( Site 3613)","city":"Lyon","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Avicenne ( Site 3602)","city":"Bobigny","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Saint-Louis ( Site 3600)","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Bichat - Claude-Bernard ( Site 3601)","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Médica Especializada en Pediatría e Infectología Pediátrica - Dr. Mario Melgar ( Site 3801)","city":"Guatemala City","state":"","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"MEDI-K ( Site 3803)","city":"Guatemala City","state":"","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"CELAN,S.A ( Site 3802)","city":"Guatemala City","state":"","country":"Guatemala","status":"RECRUITING","lat":null,"lon":null},{"facility":"Morales Vargas Centro de Investigacion, S.C. ( Site 4502)","city":"León","state":"Guanajuato","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arké SMO S.A de C.V ( Site 4505)","city":"Veracruz","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Josha Research ( Site 4302)","city":"Bloemfontein","state":"Free State","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wentworth Hospital ( Site 4303)","city":"Durban","state":"KwaZulu-Natal","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Part Yoluntu Centre ( Site 4300)","city":"Mbekweni, Paarl","state":"Western Cape","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz ( Site 3404)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consorcio Hospital General Universitario de Valencia ( Site 3406)","city":"Valencia","state":"Valenciana, Comunitat","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron ( Site 3402)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL CLÍNIC DE BARCELONA ( Site 3400)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 3405)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Virgen De La Victoria ( Site 3409)","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Phase 2: Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL at Week 24","Phase 2: Percentage of Participants Who Experience an Adverse Event (AE) at Week 24","Phase 2: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 24","Phase 3: Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48","Phase 3: Percentage of Participants Who Experience an AE at Week 48","Phase 3: Percentage of Participants Who Discontinue Study Intervention Due to an AE at Week 48"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["los-angeles-california","denver-colorado","washington-d-c-district-of-columbia","ft-pierce-florida","miami-gardens-florida","orlando-florida","sarasota-florida","west-palm-beach-florida","decatur-georgia","macon-georgia","chicago-illinois","detroit-michigan","kansas-city-missouri","hillsborough-new-jersey","charlotte-north-carolina","greensboro-north-carolina","columbus-ohio","philadelphia-pennsylvania","bellaire-texas","dallas-texas","fort-worth-texas","longview-texas","seattle-washington","caba-argentina","mar-del-plata-argentina","buenos-aires-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","vancouver-canada","montreal-canada","santiago-chile","bordeaux-france","toulouse-france","nantes-france","lyon-france","bobigny-france","paris-france","guatemala-city-guatemala","le-n-mexico","veracruz-mexico","bloemfontein-south-africa","durban-south-africa","mbekweni-paarl-south-africa","madrid-spain","valencia-spain","barcelona-spain","m-laga-spain"],"enrichment":{"headline":"Phase 2 / Phase 3: testing ISL for Human Immunodeficiency Virus Type 1 (HIV-1) Infection","inPlainEnglish":"Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1). The usual (standard) treatment for HIV-1 is antiretroviral therapy (ART), which includes taking medicines to lower the amount of HIV-1 in the body.","whoItsFor":["Ages 18 Years to any","Phase 2: Is human immunodeficiency virus type 1 (HIV-1) positive with Plasma HIV-1 ribonucleic acid (RNA) ≥500 and ≤100,000 copies/mL","Phase 3: Is HIV-1 positive with Plasma HIV-1 RNA ≥500 and ≤1,000,000 copies/mL","Phase 2: Has cluster of differentiation 4-positive (CD4+) T-cell count ≥200 cells/mm\\^3","Is naïve to antiretroviral therapy (ART), defined as having received no prior therapy with any antiretroviral agent following a diagnosis of HIV 1 infection"],"whoShouldSkip":["Has human immunodeficiency virus type 2 (HIV-2) infection","Has a diagnosis of an active acquired immune deficiency syndrome (AIDS)-defining opportunistic infection","Has active hepatitis C virus (HCV) or active hepatitis B virus (HBV) infection","Has prior exposure to islatravir (ISL) or ulonivirine (ULO) for any duration any time prior to Day 1"],"whatHappens":"If you join, the listed intervention(s) are ISL, ULO, or BIC/FTC/TAF. The registry lists allocation as randomized. Researchers are looking for new ways to treat HIV-1 (Human Immunodeficiency Virus Type 1).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 570 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.534Z"},{"nctId":"NCT07268638","title":"A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)","officialTitle":"A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Akebia Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label period for an additional 24 weeks. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.","conditions":["Focal Segmental Glomerulosclerosis"],"keywords":["Glomerular Disease","Chronic Kidney Disease","Proteinuria","Urine protein-to-creatinine ratio"],"interventions":[{"type":"DRUG","name":"Praliciguat (Part A)"},{"type":"OTHER","name":"Placebo (Part A)"},{"type":"DRUG","name":"Praliciguat (Part B)"}],"enrollment":60,"startDate":"2025-12-03","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria (Part A):\n\n1. UPCR ≥1 (g/g) during screening.\n2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.\n3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n4. Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.\n\nExclusion Criteria (Part A):\n\n1. Collapsing FSGS in the kidney biopsy report.\n2. Sickle cell disease.\n3. HbA1c \\>8%.\n4. Uncontrolled hypertension (≥160/100 millimeters of mercury).\n\nInclusion Criteria (Part B):\n\n1\\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study.","locations":[{"facility":"Investigator Site #2","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #28","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #14","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #12","city":"San Dimas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #13","city":"Arvada","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #17","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #6","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #25","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #7","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #8","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #29","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site # 1","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #3","city":"Chicago","state":"Illinois","country":"United States","status":"TERMINATED","lat":null,"lon":null},{"facility":"Investigator Site #11","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #32","city":"Catonsville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #24","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #15","city":"Livonia","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #10","city":"Pontiac","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #27","city":"Valhalla","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #16","city":"New Bern","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #31","city":"Shelby","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #20","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #30","city":"Bethlehem","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #19","city":"Bridgeville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #22","city":"Butler","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #23","city":"Goose Creek","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #4","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #5","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #21","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #9","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #18","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigator Site #26","city":"Roanoke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Akebia Therapeutics","phone":"16178446128","email":"trials@akebia.com"}],"primaryOutcomes":["Change from Baseline in urine protein-to-creatinine ratio (UPCR) (Part A)","Proportion of participants with TEAEs, serious adverse events (SAEs), and treatment-emergent adverse events of special interest (AESIs). (Part A)"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["chula-vista-california","garden-grove-california","los-angeles-california","san-dimas-california","arvada-colorado","boca-raton-florida","coral-springs-florida","hialeah-florida","miami-florida","orlando-florida","augusta-georgia","lawrenceville-georgia","chicago-illinois","louisville-kentucky","catonsville-maryland","worcester-massachusetts","livonia-michigan","pontiac-michigan","valhalla-new-york","new-bern-north-carolina","shelby-north-carolina","cleveland-ohio","bethlehem-pennsylvania","bridgeville-pennsylvania","butler-pennsylvania","goose-creek-south-carolina","chattanooga-tennessee","arlington-texas","dallas-texas","houston-texas","roanoke-virginia"],"enrichment":{"headline":"Phase 2: testing Praliciguat (Part A) for Focal Segmental Glomerulosclerosis","inPlainEnglish":"This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study designed to measure the how well it works and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). you would be randomly assigned 1:1 to receive praliciguat or dummy treatment (placebo) for initial 24 week treatment period.","whoItsFor":["Ages 18 Years to any","UPCR ≥1 (g/g) during screening","Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation","Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS"],"whoShouldSkip":["Collapsing FSGS in the kidney biopsy report","Sickle cell disease","Uncontrolled hypertension (≥160/100 millimeters of mercury)","who can join (Part B):","1\\. Participants responding to treatment will be offered the opportunity to participate in the long-term safety extension study"],"whatHappens":"If you join, the listed intervention(s) are Praliciguat (Part A), Placebo (Part A), or Praliciguat (Part B). The registry lists allocation as randomized. This is a Phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, multicenter study designed to measure the how well it works and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.490Z"},{"nctId":"NCT07271238","title":"Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures","officialTitle":"Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"LUMA Vision Ltd.","sponsorClass":"INDUSTRY","summary":"The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).\n\nResults from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.","conditions":["Atrial Fibrillation","Atrial Flutter","Atrial Arrhythmia"],"keywords":[],"interventions":[{"type":"DEVICE","name":"VERAFEYE Imaging and Guidance System"}],"enrollment":50,"startDate":"2026-03-03","completionDate":"2026-12-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* IC1: Subject is at least 18 years of age at the time of consent\n* IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local guidelines and per physician discretion\n* IC3: Subject is able to understand and willing to provide written informed consent\n* IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site\n\nExclusion Criteria:\n\n* EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion\n* EC2: Pregnant women or women who plan to become pregnant during the course of their participation in the study (women should either be of non- childbearing potential at the time of enrolment (as documented in the medical file) or have a negative pregnancy test within the previous 7 days prior to the procedure)\n* EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)\n* EC4: Unrecovered/unresolved Adverse Events from any previous invasive procedure\n* EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure\n* EC6: Life expectancy less than 12 months\n* EC7: Current LA thrombus Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.\n* EC8: Subjects who are currently enrolled in another study","locations":[{"facility":"Klinicki Bolnicki Centar (KBC) Split","city":"Split","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ivan Sikiric","phone":"+385958934912","email":"ivan.sikiric20@gmail.com"},{"name":"Ivan Aranza","phone":"+385917947452","email":"aranza.ivan@gmail.com"}],"primaryOutcomes":["ADEs","VERAFEYE Performance"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["split-croatia"],"enrichment":{"headline":"Not a traditional drug phase: VERAFEYE Imaging and Guidance System for Atrial Fibrillation","inPlainEnglish":"The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF). Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.","whoItsFor":["Ages 18 Years to any","IC1: Subject is at least 18 years of age at the time of consent","IC2: Subject is scheduled to undergo a standard of care catheter-ablation procedure to treat AFL/AF, according to current international and local guidelines and per physician discretion","IC4: Subject is able and willing to complete all study assessments associated with this clinical study at an approved clinical study site"],"whoShouldSkip":["EC1: Subject where placement of VERAFEYE Imaging Catheter is technically not feasible per physician discretion","EC3: Subject implanted with an active cardiac rhythm management device (e.g. pacemaker, CRT, ICD)","EC4: Unrecovered/unresolved side effects from any previous invasive procedure","EC5: Any planned surgical or endovascular intervention within 30 days before or after the ablation procedure","EC6: Life expectancy less than 12 months","EC8: Subjects who are currently enrolled in another study"],"whatHappens":"If you join, the listed intervention(s) are VERAFEYE Imaging and Guidance System. The registry lists allocation as na. The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Split. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.744Z"},{"nctId":"NCT07276724","title":"A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-1)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Generate Biomedicines","sponsorClass":"INDUSTRY","summary":"The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.\n\nAdditional information is available at www.SOLAIRIA.com.","conditions":["Severe Asthma"],"keywords":["Asthma","Severe Asthma","Uncontrolled Asthma","Adolescent Asthma"],"interventions":[{"type":"DRUG","name":"GB-0895"},{"type":"DRUG","name":"Placebo"}],"enrollment":786,"startDate":"2025-12-03","completionDate":"2028-12","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"1. Adults and adolescents ≥ 12 and ≤ 80 years of age.\n2. Documented diagnosis of asthma for \\> 12 months.\n3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.\n4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.\n5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\<80% predicted at Screening Visit 1.\n6. Adolescents 12 to \\< 18 years of age at Screening Visit 1: A pre-BD FEV1 \\< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\< 0.80.\n7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.\n2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis).\n4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \\>1 day during the study.\n13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.\n14. Previous use of tezepelumab within 12 months before Screening Visit 1 is excluded. Previous tezepelumab use is exclusionary regardless of 12-month washout if discontinuation was due to safety (intolerance) or treatment failure (lack of benefit). Prior use (at any time) of any other anti-TSLP or anti-TSLP receptor biologics is excluded.\n15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. Receipt of an investigational biologic within 4 months or 5 half-lives (whichever is longer), OR receipt of an investigational non-biologic within 30 days or 5 half-lives (whichever is longer) before Screening Visit 1.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.","locations":[{"facility":"Research Site 23","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 26","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 29","city":"Rancho Cucamonga","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 34","city":"Valencia","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 13","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 15","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 32","city":"Brooksville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 12","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 14","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 03","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 25","city":"Kendall","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 04","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 01","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 08","city":"North Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 10","city":"Palm Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 02","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 18","city":"Rincon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 31","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 16","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 28","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 20","city":"Towson","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 144","city":"North Dartmouth","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 06","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 30","city":"Olive Branch","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 37","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 27","city":"Gastonia","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 83","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 24","city":"Amarillo","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 19","city":"Baytown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 07","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 17","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 11","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 09","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 22","city":"Kerrville","state":"Texas","country":"United 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3: testing GB-0895 for Severe Asthma","inPlainEnglish":"The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.","whoItsFor":["Ages 12 Years to 80 Years","Adults and adolescents ≥ 12 and ≤ 80 years of age","Documented diagnosis of asthma for \\> 12 months","Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months","Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1","Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\<80% predicted at Screening Visit 1","Adolescents 12 to \\< 18 years of age at Screening Visit 1: A pre-BD FEV1 \\< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\< 0.80","Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period"],"whoShouldSkip":["Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy","Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis)","Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment","A current malignancy or previous history of cancer within 5 years before screening","Clinically significant infection that is not resolved before study enrollment","Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy","Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes"],"whatHappens":"If you join, the listed intervention(s) are GB-0895, or Placebo. The registry lists allocation as randomized. The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 786 people at 153 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.340Z"},{"nctId":"NCT07277322","title":"Neoadjuvant Dupilumab and Toripalimab in MSS CRC Subjects With Resectable Liver Metastases","officialTitle":"Master Protocol for A Phase 1b/2 Study of Neoadjuvant Immunotherapy in Microsatellite Stable (MSS) Colorectal Cancer (CRC) Subjects With Resectable Liver Metastases","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Dan Feng","sponsorClass":"OTHER","summary":"This Phase 1b/2 trial will evaluate the safety and efficacy of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.","conditions":["Metastatic Colorectal Cancer","Liver Metastases"],"keywords":["Colorectal cancer","Liver metastases","Neoadjuvant immunotherapy","Dupilumab","Toripalimab","microsatellite stable"],"interventions":[{"type":"DRUG","name":"Dupilumab"},{"type":"DRUG","name":"Toripalimab"}],"enrollment":24,"startDate":"2026-09-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA:\n\nHistological diagnosis of non-MSI-H/pMMR CRC\n\n• Subjects who have biology-proven non-MSI-H/pMMR CRC and with radiographic findings suggestive of liver metastases may be eligible.\n\nResectable liver metastases including:\n\n* synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve\n* metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy\n* metachronous liver metastasis (developed after resection of the primary tumor) with adjuvant chemotherapy completed greater than 3 months from the time of consent.\n\nSurgical candidate for resection\n\nAge ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects \\<18 years of age, children are excluded from this study.\n\nECOG Performance Status 0-1 (Karnofsky ≥60%,)\n\n• Subjects with performance status \\>1 carrying long-term disability (such as cerebral palsy) where the disability is not acute nor progressive, and unlikely to significantly affect their response to therapy may be enrolled at the investigator's discretion\n\nWomen of child-bearing potential (WOCBP) and men must agree to use adequate contraception upon study entry, for the duration of study participation, and for 3 months following completion of therapy.\n\n* A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n  * Has not undergone a hysterectomy or bilateral oophorectomy; or\n  * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n\nAbility to understand and the willingness to sign a written informed consent. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nAdequate organ and marrow function as defined:\n\n* Hematologic\n\n  o Absolute neutrophil count (ANC) ≥1,000 /mcL\n  * Platelets ≥75,000 /mcL\n  * Hemoglobin ≥8 g/dL\n* Renal\\* o Serum creatinine ≤1.5 X upper limit of normal (ULN) OR Measured or calculated (Creatinine clearance should be calculated per institutional standard) creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥45 mL/min for subjects with creatinine levels \\> 1.5 X institutional ULN\n* Hepatic\\* o Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \\> 1.5 ULN; ≤ 3 X ULN for subjects with liver metastases o AST ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n\n  * ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases\n  * Albumin \\>2.5 mg/dL\n* Coagulation\\*\n\n  * International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT is within therapeutic range of intended use of anticoagulants\n  * Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy as long as PTT is within therapeutic range of intended use of anticoagulants \\* If laboratory criteria are not met due to what the investigator determines to be a biologic cause (e.g. Gilbert's syndrome causing elevated bilirubin or excessive muscle mass affecting creatinine) or drug-related cause (e.g. elevating in transaminases due to HAART therapy, elevated INR due to anticoagulation) then the lab values will not be used to exclude subject from this trial. This determination will be made by PI.\n\nEXCLUSION CRITERIA:\n\nHistory of autoimmune disorder with the following exceptions:\n\n* Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy\n* Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement\n* Celiac disease controlled by diet alone\n\nTreatment, for any reason, with an immunomodulatory drug, within 8 weeks from time of consent.\n\nPrior treatment with dupilumab within the last 8 weeks.\n\nPrior treatment with chemotherapy for MSS CRC or locoregional therapy to the target lesion (that will be biopsied and subsequently resected) within 3 months prior to entering the study.\n\n• Previous therapy for a different cancer (a different primary) is acceptable.\n\nUse of investigational agents for treatment of cancer.\n\nSubjects with extrahepatic metastases that are not amendable to resectable or locoregional therapy, for whom the intent of surgery would not be curative.\n\nUncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10 days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements, as determined the treating investigator.\n\nPregnant or nursing women due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.\n\n• Breastfeeding should be discontinued prior to study enrollment.\n\nHas a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n\n• Chronic steroids equivalent to ≤ 10mg prednisone are permitted.\n\nHas active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n\n• Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted.\n\nHas a known additional malignancy that is progressing and requires active treatment.\n\n• Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical or anal cancer, prostate cancer on stable dose of hormonal therapy without rising PSA, and breast cancer treated with curative intent now on hormonal therapy.\n\nHas a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.\n\nHIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \\<200 CD4+ T cells/microliter in the peripheral blood. HIV testing is mandatory for patients with no known history of HIV. For such patients, HIV testing will be considered SOC.\n\nHas known active Hepatitis B (e.g., HBV detected by PCR (\\>200 IU/ml) or known active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n\n• Subjects who started antiviral therapy \\>/=14days from baseline are permitted.\n\nHistory of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n\nDocumented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps) Principle investigator believes that for one or multiple reasons the subject will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the subject.","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Fitzgerald","phone":"(917) 748-0962","email":"lisa.fitzgerald@mssm.edu"},{"name":"Rashmi Unawane","phone":"(212) 824-2385","email":"rashmi.unawane@mssm.edu"}],"primaryOutcomes":["Number of dose limiting toxicities (DLTs)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":["dupilumab"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Dupilumab for Metastatic Colorectal Cancer","inPlainEnglish":"This Phase 1b/2 trial will measure the safety and how well it works of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.","whoItsFor":["Ages 18 Years to any","Histological diagnosis of non-MSI-H/pMMR CRC","Subjects who have biology-proven non-MSI-H/pMMR CRC and with radiographic findings suggestive of liver metastases may be eligible","Resectable liver metastases including:","synchronous liver metastases (present at the time of diagnosis of MSS CRC) and treatment-naïve","metachronous liver metastasis (developed after resection of the primary tumor) without prior adjuvant chemotherapy","Surgical candidate for resection","Age ≥ 18 years. Rationale: Because no dosing or adverse event data are currently available on the use of dupilumab in combination with toripalimab in subjects \\<18 years of age, children are excluded from this study"],"whoShouldSkip":["History of autoimmune disorder with the following exceptions:","Vitiligo, alopecia, psoriasis or any chronic skin condition that does not require systemic therapy","Hypothyroidism (e.g. following autoimmune thyroiditis) stable on thyroid replacement","Celiac disease controlled by diet alone","Treatment, for any reason, with an immunomodulatory drug, within 8 weeks from time of consent","Prior treatment with dupilumab within the last 8 weeks","Prior treatment with chemotherapy for MSS CRC or locoregional therapy to the target lesion (that will be biopsied and subsequently resected) within 3 months prior to entering the study"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab, or Toripalimab. The registry lists allocation as na. This Phase 1b/2 trial will measure the safety and how well it works of neoadjuvant immunotherapy in microsatellite stable (MSS) colorectal cancer (CRC) subjects with resectable liver metastases.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 24 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.712Z"},{"nctId":"NCT07278856","title":"Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas","officialTitle":"Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma. Ruxolitinib phosphate blocks a protein called janus kinase, which may help keep abnormal blood cells or cancer cells from growing. It may also lower the body's immune response. Ruxolitinib phosphate is a type of tyrosine kinase inhibitor. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Doxorubicin is a type of anthracycline antitumor antibiotic. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving ruxolitinib in combination with CHOP chemotherapy may be safe, tolerable, and/or effective in treating patients with untreated nodal TFH cell lymphoma.","conditions":["Follicular Helper T-Cell Lymphoma","Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type","Follicular Helper T-Cell Lymphoma, Follicular-Type","Follicular Helper T-Cell Lymphoma, Not Otherwise Specified","Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma","Peripheral T-Cell Lymphoma, Not Otherwise Specified"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Doxorubicin"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"FDG-Positron Emission Tomography"},{"type":"BIOLOGICAL","name":"Filgrastim"},{"type":"OTHER","name":"Fludeoxyglucose F-18"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"BIOLOGICAL","name":"Pegfilgrastim"},{"type":"DRUG","name":"Prednisone"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"DRUG","name":"Ruxolitinib Phosphate"},{"type":"DRUG","name":"Vincristine"}],"enrollment":20,"startDate":"2025-12-16","completionDate":"2027-12-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to understand and willingness to sign a written informed consent document\n* Documented informed consent of the participant and/or legally authorized representative.\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Be ≥ 18 years of age on day of signing informed consent\n* Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale (PS) at time of enrollment. Patients with a performance status of 2 on the ECOG scale due to lymphoma may be eligible with principal investigator (PI) approval\n* Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas. Nodal TFH cell lymphomas include encompasses three subtypes:\n\n  * Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization \\[WHO\\]4R)/follicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (ICC)/nodal TFH cell lymphoma, angioimmunoblastic-type (WHO5)\n  * Nodal peripheral T-cell lymphoma (PTCL) with TFH phenotype (nodal PTCL, TFH)(WHO4R)/TFH lymphoma, NOS (ICC)/nodal TFH cell lymphoma, not otherwise specified (NOS) (WHO5)\n  * Follicular T-cell lymphoma (FTCL)(WHO4R)/TFH lymphoma, follicular type (ICC)/ nodal TFH cell lymphoma, follicular-type (WHO5)\n* Must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care for untreated nodal TFH cell lymphoma\n* Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on CT or FDG-PET or marrow-only disease (disease only found on bone marrow biopsy)\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n* Absolute neutrophil count (ANC) ≥ 1,000/mm\\^3\n* Hemoglobin ≥ 8 g/dL\n* Platelets ≥ 100,000/mm\\^3 (≥ 50,000/mm\\^3 in cases of marrow infiltration by lymphoma or hypersplenism per investigator assessment)\n* Measured or calculated creatinine clearance ≥ 60 mL/min (glomerular filtration rate \\[GFR\\] can also be used in place of creatinine clearance \\[CrCl\\])\n\n  * Creatinine clearance should be calculated per institutional standard\n* Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN)\n\n  * (Patients with documented liver or pancreatic involvement with lymphoma may be enrolled if total bilirubin ≤ 3.0 x ULN. Patients with documented Gilbert disease may be enrolled if total bilirubin ≤ 5.0 x ULN) OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x ULN OR ≤ 5 x ULN for patients with liver involvement\n* International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN\n\n  * Note: unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, or patient is shown to have an antiphospholipid antibody on workup\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN\n\n  * Note: unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants, or patient is shown to have an antiphospholipid antibody on workup\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of ≤ 1% per year during the treatment period and for at least 4 months after the last dose of study treatment. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is post-menarchal, has not reached a postmenopausal state (≤ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of ≤ 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception\n* For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test\n* For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 4 months after the last treatment. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of preventing drug exposure. Male patients considering preservation of fertility should bank sperm before study treatment\n* TO BE ASSESSED UPON COMPLETION OF PART A FOR CONSIDERATION FOR PART B ONLY: Completion of first-line multi-agent chemotherapy with ruxolitinib with CHOP\n* TO BE ASSESSED UPON COMPLETION OF PART A FOR CONSIDERATION FOR PART B ONLY: Documentation of response (PR or CR) per Lugano criteria within the previous 3 months\n* TO BE ASSESSED UPON COMPLETION OF PART A FOR CONSIDERATION FOR PART B ONLY: Ineligible for or decline consolidative autologous stem cell transplantation. Ineligibility is defined by:\n\n  * Patient deemed ineligible for high-dose chemotherapy and ASCT based on physician's assessment\n  * AND at least one of the following criteria:\n\n    * Age ≥ 65 years or\n    * Age ≥ 18 years and Hematopoietic Cell Transplantation-specific Comorbidity Index (HCT-CI) score ≥ 3\n* TO BE ASSESSED UPON COMPLETION OF PART A FOR CONSIDERATION FOR PART B ONLY: Recovery to ≤ grade 1 or baseline for any toxicities due to prior treatments, with the exception of peripheral neuropathy (recovery to ≤ grade 2) or alopecia\n\nExclusion Criteria:\n\n* Contraindication to any of the individual components of CHOP, or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (450 mg/m\\^2)\n* Prior systemic treatment or radiation for T-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner:\n\n  * Up to 30 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment). If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of \\> 30-100 mg/day of prednisone or equivalent. Prednisone \\> 30-100 mg/day or equivalent may be given for a maximum of 7 days as a pre-phase treatment. If patients exceed the allowed dosing of corticosteroids, patients may still be eligible for the study provided that baseline imaging is performed (or repeated) after completion of the course of higher dose of steroids. Allowed corticosteroid dosing resets from the point of imaging forward and patients who do not exceed the allowed corticosteroid dosing from the point of imaging until initiation of study treatment may enroll\n* Prior organ transplantation\n* Known history of cirrhosis\n* Current grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:\n\n  * Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible\n  * Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible\n  * Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, stage 1 or 2) with no requirement for therapy at any time prior to study are eligible\n* Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* History of thrombosis, such as stroke or pulmonary embolism/deep vein thrombosis, within the last 6 months\n* Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis\n* History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction in the last 6 months\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for infection, but systemic treatment must be completed by cycle 1 day 1\n\n  * If a patient has signs/symptoms suggestive of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the patient must have a negative molecular (e.g., polymerase chain reaction \\[PCR\\]) test or 2 negative antigen test results at least 24 hours apart. Patients who do not meet SARS-CoV-2 infection eligibility criteria must be screen-failed and may only be rescreened if the following have been met:\n  * At least 10 days since first positive test result have passed in asymptomatic patients or at least 10 days since recovery, defined as resolution of fever without use of antipyretics and improvement in symptoms\n* Current and/or history of active tuberculosis or latent tuberculosis\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology):\n\n  * Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. These patients must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated by institutional standard\n* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing)\n\n  * Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA)\n* History of uncontrolled HIV\n\n  * Patients with known diagnosis of HIV must have undetectable viral load and be on anti-retroviral therapy\n* Known human T cell lymphotropic virus (HTLV) 1/2\n* Untreated latent tuberculosis\n* Patients with known active central nervous system lymphoma\n* Pregnancy or lactation or intending to become pregnant during study\n* Symptomatic inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the study drug (ruxolitinib) and/or predispose the subject to an increased risk of gastrointestinal toxicity\n* Use of medications or consumption of foods that are strong inducers or inhibitors of cytochrome P450 (CYP)3A must be discontinued at least 2 weeks prior to study intervention. Patients who (after enrollment) require use of a strong CYP3A4 inhibitor to treat a fungal/mold infection will require dose reductions\n* Participants who are receiving other investigational agents\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Maximum tolerated dose (MTD) of ruxolitinib when given in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy","Incidence of adverse events"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Cyclophosphamide for Follicular Helper T-Cell Lymphoma","inPlainEnglish":"This phase I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma. Ruxolitinib phosphate blocks a protein called janus kinase, which may help keep abnormal blood cells or cancer cells from growing.","whoItsFor":["Ages 18 Years to any","Assent, when appropriate, will be obtained per institutional guidelines","Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale (PS) at time of enrollment. Patients with a performance status of 2 on the ECOG scale due to lymphoma may be eligible with principal investigator (PI) approval","Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas. Nodal TFH cell lymphomas include encompasses three subtypes:","Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization \\[WHO\\]4R)/follicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (ICC)/nodal TFH cell lymphoma, angioimmunoblastic-type (WHO5)","Nodal peripheral T-cell lymphoma (PTCL) with TFH phenotype (nodal PTCL, TFH)(WHO4R)/TFH lymphoma, NOS (ICC)/nodal TFH cell lymphoma, not otherwise specified (NOS) (WHO5)","Follicular T-cell lymphoma (FTCL)(WHO4R)/TFH lymphoma, follicular type (ICC)/ nodal TFH cell lymphoma, follicular-type (WHO5)","Must be planned to receive full course (6 cycles) chemoimmunotherapy as per clinical standard of care for untreated nodal TFH cell lymphoma"],"whoShouldSkip":["Contraindication to any of the individual components of CHOP, or if receiving an additional 6 cycles of anthracycline would place patient over the anthracycline lifetime cumulative dose (450 mg/m\\^2)","Prior systemic treatment or radiation for T-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner:","Prior organ transplantation","Known history of cirrhosis","Current grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease","History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:","Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Marrow Aspiration, or Bone Marrow Biopsy. The registry lists allocation as na. This phase I trial tests the safety, side effects and best dose of ruxolitinib in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) chemotherapy and how well the combination works in treating patients with untreated nodal T-follicular helper (TFH) cell lymphoma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Duarte. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.161Z"},{"nctId":"NCT07279935","title":"Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC.","officialTitle":"Biomarker-Directed Treatment in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resectable SIB-IIIA NSCLC: A Prospective, Multi-cohort, Interventional Study (REVIVE)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1. In this cohort, approximately 100 patients will be recruited from 25 sites in China. The enrolment period is planned to be approximately 16 months.","conditions":["Non-small Cell Lung Cancer"],"keywords":["Carcinoma, Bronchogenic","Bronchial Neoplasms","Lung Neoplasms","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Lung Diseases","Respiratory Tract Diseases","Carcinoma, Non-Small-Cell Lung","osimertinib"],"interventions":[{"type":"DRUG","name":"Osimertinib+cisplatin or carboplatin + pemetrexed Edit"}],"enrollment":100,"startDate":"2026-05-26","completionDate":"2030-05-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for pre-screening:\n\n1. Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition).\n2. Off-treatment recurrence (including completed 3 years adjuvant osimertinib \\& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason).\n3. Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer \\[IASLC\\] Staging Manual in Thoracic Oncology).\n4. ≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib.\n5. Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)\n6. No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice).\n7. Patients with asymptomatic or stable CNS metastases allowed.\n\nInclusion Criteria for screening:\n\n1. Male or female, at least 18 years of age. Type of patient and disease characteristics\n2. EGFR mutation (Exon 19del/Exon 21 L858R)-reconfirmed for study entry (mandatory undergo NGS by plasma, and tissue if applicable).\n3. Life expectancy \\>12 weeks at Day 1.\n\nExclusion Criteria:\n\n1. Patients with only local/regional recurrence.\n2. Spinal cord compression and symptomatic brain metastases.\n3. Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n4. Adjuvant osimertinib therapy was discontinued due to the occurrence of severe adverse events.\n5. Prior with other adjuvant EGFR-TKIs (excluding osimertinib).\n6. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n7. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.\n8. Contraindication for pemetrexed and cisplatin/carboplatin according to local approved label.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinan","state":"","country":"China","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Kunming","state":"","country":"China","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Ningbo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhengzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["To assess the efficacy of osimertinib + chemotherapy by evaluation of PFS in patients who had distant recurrence after adjuvant osimertinib."],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["beijing-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","hangzhou-china","hefei-china","jinan-china","kunming-china","nanchang-china","nanjing-china","ningbo-china","shanghai-china","shenyang-china","tianjin-china","wuhan-china","xian-china","zhengzhou-china"],"enrichment":{"headline":"Phase 4: testing Osimertinib+cisplatin or carboplatin + pemetrexed Edit for Non-small Cell Lung Cancer","inPlainEnglish":"This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future. EGFR-sensitive mutation-positive patients with distant recurrence after adjuvant osimertinib treatment for EGFRm resectable SIB-IIIA NSCLC and scheduled to receive osimertinib plus chemotherapy will be enrolled in cohort 1.","whoItsFor":["Ages 18 Years to any","Prior complete surgical resection (R0) and adjuvant osimertinib in EGFRm resectable SIB-IIIA NSCLC (AJCC 7th edition)","Off-treatment recurrence (including completed 3 years adjuvant osimertinib \\& discontinued adjuvant osimertinib before 3 years due to non-recurrence reason)","Newly diagnosed distant recurrent NSCLC (IVA or IVB) (per Version 9 of the International Association for the Study of Lung Cancer \\[IASLC\\] Staging Manual in Thoracic Oncology)","≥6 months interval between recurrence and completion or discontinuation of adjuvant osimertinib","Histologically/cytologically confirmed nonsquamous NSCLC (Investigators confirmed recurrence of primary lesion allowed if biopsy not available)","No prior systemic anti-cancer therapy after adjuvant therapy, but can receive local therapy (including surgery, radiotherapy, etc. per investigator choice)","Patients with asymptomatic or stable CNS metastases allowed"],"whoShouldSkip":["Patients with only local/regional recurrence","Spinal cord compression and symptomatic brain metastases","Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening","Adjuvant osimertinib therapy was discontinued due to the occurrence of severe side effects","Prior with other adjuvant EGFR-TKIs (excluding osimertinib)","Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib","History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib+cisplatin or carboplatin + pemetrexed Edit. The registry lists allocation as na. This study is designed as a multi-cohort trial based on various patient biomarkers study with the potential to include new study treatment in the future.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.679Z"},{"nctId":"NCT07281456","title":"Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease","officialTitle":"Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Disease Phase IIa Open-Label Clinical Trial and Associated Mechanistic Studies","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Institute of Dental and Craniofacial Research (NIDCR)","sponsorClass":"NIH","summary":"Background:\n\nSjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune diseases can help people with Sjogren disease.\n\nObjective:\n\nTo test a drug (tofacitinib) in people with Sjogren disease.\n\nEligibility:\n\nPeople aged 18 to 75 years with Sjogren disease. They must be enrolled in protocol 15-D-0051.\n\nDesign:\n\n* Participants will be screened. They will have a physical exam with blood and urine tests. They will give samples of saliva; a small sample of tissue will be taken from a salivary gland. They will have a test of their heart function. They will have an eye exam, including a test for dry eyes.\n* Tofacitinib is a tablet taken by mouth. Participants will take the drug twice a day at home.\n* Participants will have 9 clinic visits over 28 weeks. Each visit will take up to 5 hours. In addition to repeated tests, they will have tests of the speed and pressure of blood flow through their body. They will complete health questionnaires throughout the study.\n* Participants will also have 5 phone visits during the study. They will review their health and study treatments.\n* They will have 1 final visit after they stop taking the drug.","conditions":["Sjogren's Syndrome"],"keywords":["Salivary","Dry Mouth","Safety","Inflammation","Xerostomia","Jak","Autoimmune","Xerophthalmia","Lacrimal","Exocrine"],"interventions":[{"type":"DRUG","name":"Tofacitinib"}],"enrollment":60,"startDate":"2025-12-18","completionDate":"2030-12-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAdult SjD participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naive or have failed immunosuppressive therapy beyond antimalarials and glucocorticoids, to prevent bias in the cohort of participants with more recalcitrant disease. We expect that Tofacitinib is a potential second-line therapy, in addition to antimalarials and glucocorticoids, depending on the participant's initial presentation and response. Women and members of minority groups, if eligible, will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Participants.\n\nAdditionally, 20-D-0131(Safety of Tofacitinib, an oral Janus Kinase Inhibitor, in primary Sjogren's syndrome Phase Ib-IIa placebo-controlled clinical trial and associated mechanistic studies) participants who, at unblinding, received a placebo will be contacted and asked to return to the study to participate in this study.\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document.\n2. Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Male or female, aged between 18-75 years old\n5. In good general health as evidenced by medical history\n6. Meets the 2002 American European Consensus Group classification criteria for Sjogren's disease or 2016 American College of Rheumatology/European League against Rheumatism Classification Criteria (ACR-EULAR) with mild to moderate disease activity defined as ESSDAI between 0 and 13 at the screening visit and \\>0 ml/min/gland stimulated saliva flow.\n7. Ability to take oral medication and be willing to adhere to the study intervention regimen\n8. If on glucocorticoids, the dose must be less than 10 mg daily and stable for the 4 weeks (28 days) prior to the screening visit.\n9. If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for the 12 weeks (96 days) prior to screening visit. The maximum allowed dose is hydroxychloroquine up to 400 mg/day or 6.5 mg/kg/day if more than 400 mg/day. The maximum allowed dose for chloroquine phosphate is up to 500 mg daily and for quinacrine up to 100 mg daily.\n10. Participants may be on lipid lowering medications if initiated at least 3 months prior to the screening visit and dose must be stable for 4 weeks (28 days) prior to study entry.\n11. Males and females with potential for reproduction must agree to practice effective birth control measures. Females should be on adequate contraception if they are of child-bearing potential documented by a clinician, unless participants or spouse have previously undergone a sterilization procedure. Adequate birth control measures are: intrauterine device (IUD) alone or hormone implants, hormone patches, injectable, or oral contraceptives plus a barrier method (male condom, female condom or diaphragm), abstinence or a vasectomized partner.\n12. Agreement to adhere to Lifestyle Considerations throughout study duration\n\nEXCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must not meet any of the following criteria:\n\n1. Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening.\n2. Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening.\n3. Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), not otherwise specified herein. Participants previously on methotrexate, azathioprine, mycophenolate mofetil, cyclosporine or tacrolimus, or other DMARDs should have withdrawn drug for at least 8 weeks (56 days) at the time of screening. The use of topical or ophthalmic preparations of cyclosporine, tacrolimus, or other DMARDs is permitted and does not require an 8-week withdrawal period.\n4. Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening.\n5. Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) that would increase serum availability of Tofacitinib. Past treatment with the agent is allowed if it was more than a week prior to the administration of the first dose of study medication.\n6. History of chronic liver disease, not including well-controlled Sjogren's-related chronic liver disease or elevated LFTs:\n\n   * ALT or AST \\>= 2x upper limit of normal at screening\n   * Serum unconjugated bilirubin \\> 2mg/dL at screening\n7. Serum creatinine \\>1.5mg/dL.\n8. Protein to creatinine ratio of more than 1mg/dL at screening (repeated and confirmed three times or confirmed with 24 hours urine protein of more than 1000mg).\n9. Active urinary sediment (WBC, RBC or mixed cellular casts 1+ or more /hpf).\n10. Hypercholesterolemia: Values after 8-12 hour fasting blood specimen: total cholesterol \\>250 mg/dL or LDL \\>180 mg/dL or hypertriglyceridemia (triglyceride \\>300 mg/dL) within - 45 days of screening visit.\n11. WBC \\<2500/microL or ANC \\<1,000/microL, Hgb \\<9.0 g/dL or platelets \\<70,000/microL or absolute lymphocyte count \\< 500/microL.\n12. Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.\n13. A history of drug or alcohol abuse within the 6 months prior to screening.\n14. Currently receiving hemodialysis, peritoneal dialysis, or intestinal dialysis.\n15. Active infection that requires the use of oral or intravenous antibiotics unresolved at least 14 days prior to the administration of the first dose of study medication.\n16. Active chronic infections including but not limited to HIV, Hepatitis B, Hepatitis C, and BK viremia at screening visit.\n17. Current or previous diagnosis of malignant disease, except for basal cell or squamous cell carcinoma of the skin with complete excision and clear borders or adequately treated in situ carcinoma of the cervix.\n18. Known active tuberculosis. Participants with treated latent tuberculosis (LTB) will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease (I.D.) consultant and may become eligible for trial based on infectious disease consultant recommendations.\n19. History of severe or systemic infections caused by common pathogens, or history of infection with pathogens that do not normally cause human disease.\n20. Participants with active renal or central nervous system disease or a high activity level in any organ system (except articular) in ESSDAI54.\n21. Participants with known increased risk factors for major adverse cardiac event (MACE) including a history of:\n\n    * Ischemic heart disease (e.g., history of acute myocardial infarction)\n    * Heart failure\n    * Cardiomyopathy\n    * Severe valvular heart disease\n    * Significant arrhythmias\n    * Chronic renal failure\n    * Cerebrovascular accident or transient ischemic attack\n    * Uncontrolled diabetes mellitus\n    * Uncontrolled hypertension\n    * Current smokers or former smokers with less than 3 years since complete cessation and/or \\>20 pack-years of smoking history.\n22. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the Investigator, would jeopardize the participant's safety following exposure to the Tofacitinib.\n23. Known history of arterial or venous thrombosis or at high risk for clotting disorder\n24. Psychiatric illness or history of medical non-compliance that the study team feels will make the patient unlikely to complete the study\n25. Uncontrolled thyroid disease as determined by PI or medically responsible investigator.\n26. Known allergic reactions to Tofacitinib or its components\n27. Treatment with another investigational drug/intervention within six months except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sasha D Nuby","phone":"(301) 529-7924","email":"sasha.clary@nih.gov"},{"name":"Blake M Warner, D.D.S.","phone":"(301) 500-8063","email":"blake.warner@nih.gov"}],"primaryOutcomes":["Number of Adverse Events by Grade/Category","Participants With Adverse Events"],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing Tofacitinib for Sjogren's Syndrome","inPlainEnglish":"Background: Sjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs.","whoItsFor":["Ages 18 Years to 75 Years","To be eligible to participate in this study, an individual must meet all of the following criteria:","Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged between 18-75 years old","In good general health as evidenced by medical history","Ability to take oral medication and be willing to adhere to the study intervention regimen","If on glucocorticoids, the dose must be less than 10 mg daily and stable for the 4 weeks (28 days) prior to the screening visit"],"whoShouldSkip":["To be eligible to participate in this study, an individual must not meet any of the following criteria:","Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening","Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening","Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening","History of chronic liver disease, not including well-controlled Sjogren's-related chronic liver disease or elevated LFTs:","ALT or AST \\>= 2x upper limit of normal at screening","Serum unconjugated bilirubin \\> 2mg/dL at screening"],"whatHappens":"If you join, the listed intervention(s) are Tofacitinib. The registry lists allocation as na. Background: Sjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.957Z"},{"nctId":"NCT07281924","title":"Hepzato Kit and Opdualag for Metastatic Melanoma and Liver Metastasis","officialTitle":"A Phase 1b/2 Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of Melphalan Percutaneous Hepatic Perfusion Therapy (HEPZATO KIT™) With Nivolumab and Relatlimab (Opdualag) in Patients With Metastatic Melanoma and Liver Metastasis","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.","conditions":["Metastatic Melanoma","Liver Metastases"],"keywords":["immunotherapy","Liver metastases","Anti-PD-1","Anti-LAG-3","Melphalan","Percutaneous Hepatic Perfusion Therapy","Liver directed therapy","Nivolumab","Relatlimab","Immune Checkpoint Inhibitors","Hepzato","Opdualag"],"interventions":[{"type":"DRUG","name":"Nivolumab and Relatlimab"},{"type":"DEVICE","name":"Melphalan"}],"enrollment":15,"startDate":"2026-11","completionDate":"2030-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required.\n* 0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment.\n* Evaluable/measurable disease according to RECIST v1.1.\n* Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration.\n* Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).\n\nExclusion Criteria:\n\n* Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)\n* Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion.\n* History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related adverse events (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate.\n* Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation.\n* Prednisone use greater than or equal to 10 mg/d or equivalent\n* Organ transplant recipients","locations":[{"facility":"UW Hospital and Clinics","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cancer Connect","phone":"800-622-8922","email":"clinicaltrials@cancer.wisc.edu"}],"primaryOutcomes":["Incidence and Severity of Dose Limiting Toxicities (DLTs)","Incidence of Treatment-Emergent Adverse Events","Incidence of Serious Treatment-Emergent Adverse Events","Number of Participants that Discontinue Treatment due to Adverse Events","Overall Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["nivolumab"],"locationSlugs":["madison-wisconsin"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Nivolumab and Relatlimab for Metastatic Melanoma","inPlainEnglish":"This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed metastatic melanoma with liver metastasis (LM). Liver biopsy positive for presence of melanoma metastases is required","0-1 line of prior systemic therapy in the unresectable/metastatic setting - prior adjuvant anti-programmed cell death-1 (anti-PD-1) or BRAF/MEK targeted therapy is considered 1 line of prior systemic therapy if less than 6 months from the last treatment","Evaluable/measurable disease according to RECIST v1.1","Demonstrate adequate organ function; all screening labs to be obtained within 28 days prior to registration","Patients must weigh greater than or equal to 35 kilograms (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System)"],"whoShouldSkip":["Prior treatment with HEPZATO KIT™ or nivolumab and relatlimab (Opdualag™)","Radiotherapy is permitted within 30 days prior to C1D1 as long as radiation is given with palliative intent and towards a non-target lesion","History of hypersensitivity or treatment discontinuation due to grade 3+ immune-related side effects (irAEs) from prior anti-PD-(L)1 therapy. Patients who are able to successfully resume immune checkpoint therapy without recurrence of grade 3 irAEs are eligible to participate","Symptomatic or uncontrolled brain metastases, leptomeningeal disease, or spinal cord compression not definitively treated with surgery or radiation","Prednisone use greater than or equal to 10 mg/d or equivalent","Organ transplant recipients"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab and Relatlimab, or Melphalan. The registry lists allocation as na. This study is being done to see if combining HEPZATO KIT™ with nivolumab and relatlimab (Opdualag™) in patients with metastatic melanoma with liver metastasis is safe, tolerable, and will have a synergistic effect leading to improved clinical outcomes compared to the historic cohort of patients with liver metastasis treated with combination immune checkpoint inhibitor therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 15 people at Madison. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.016Z"},{"nctId":"NCT07282210","title":"Efficacy and Safety of SIL-8301 for Control of Hemolysis in a Uniform Sickle Cell Disease Endotype","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension to Determine Efficacy and Safety of SIL-8301 in Sickle Cell Disease (SCD) Patients With a Predominantly Hemolytic Phenotype","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Biossil Inc.","sponsorClass":"INDUSTRY","summary":"SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. The purpose of this study is to compare the effects of senicapoc to placebo in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as evidence of ongoing hemolysis and a baseline Hb of 9.5 g/dL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care. Participants will take senicapoc or matching placebo daily and continue on hydroxyurea as prescribed for up to 24 weeks. Eligible participants that complete the 24 weeks will have an opportunity to receive senicapoc for up to 2 years in an optional open label extension.","conditions":["Sickle Cell Disease","Sickle Cell Anaemia","Sickle Cell Anemia"],"keywords":["senicapoc","Anemia, Hemolytic, Congenital","Anemia, Hemolytic","Anemia","Hematologic Diseases","Hemic and Lymphatic Diseases","Hemoglobinopathies","Genetic Diseases, Inborn","Congenital, Hereditary, and Neonatal Diseases and Abnormalities","Anemia, Sickle Cell","Anaemia, Sickle Cell"],"interventions":[{"type":"DRUG","name":"Senicapoc"},{"type":"DRUG","name":"Placebo"}],"enrollment":65,"startDate":"2026-11","completionDate":"2029-10","sex":"ALL","minAge":"16 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented diagnosis of sickle cell disease (SCD)\n* 16-50 years of age\n* Hemoglobin (Hb) ≤ 9.5 g/dL\n* History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years\n* Steady-state hemolysis\n* Current treatment with hydroxyurea\n\nExclusion Criteria:\n\n* Receipt of senicapoc in a previous investigational study\n* Current Red Blood Cell (RBC) transfusion or exchange transfusion program\n* History of pulmonary hypertension\n* Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders\n* Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years\n* History of liver disease","locations":[{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Health Network, Toronto General Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal (CHUM)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Head of Clinical Operations","phone":"(978) 245-7397","email":"trials@biossil.ai"}],"primaryOutcomes":["Hb response rate"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["toronto-canada","montreal-canada"],"enrichment":{"headline":"Phase 2: testing Senicapoc for Sickle Cell Disease","inPlainEnglish":"SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children. this study wants to compare the effects of senicapoc to dummy treatment (placebo) in patients with sickle cell disease that have had fewer than 2 acute sickle-related painful crises per year over the preceding 2 years, and have a predominantly hemolytic phenotype, defined as evidence of ongoing hemolysis and a baseline Hb of 9.5 g/dL or less, despite receiving hydroxyurea (an oral drug used for treatment of sickle cell disease) as standard of care.","whoItsFor":["Ages 16 Years to 50 Years","Documented diagnosis of sickle cell disease (SCD)","Hemoglobin (Hb) ≤ 9.5 g/dL","History of no more than 1 acute SCD-related painful crises requiring a visit to a medical facility per year within the preceding 2 years","Steady-state hemolysis","Current treatment with hydroxyurea"],"whoShouldSkip":["Receipt of senicapoc in a previous investigational study","Current Red Blood Cell (RBC) transfusion or exchange transfusion program","History of pulmonary hypertension","Active cardiovascular, neurologic, endocrine, hepatic, or renal disorders","Diagnosis of cancer (except non-melanoma skin cancer in situ, cervical cancer in situ, or breast cancer in situ) within the last 5 years","History of liver disease"],"whatHappens":"If you join, the listed intervention(s) are Senicapoc, or Placebo. The registry lists allocation as randomized. SIL-8301 (senicapoc) is being developed for the chronic treatment of patients with sickle cell disease in both adults and children.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 65 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.835Z"},{"nctId":"NCT07282574","title":"A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)","officialTitle":"A Multi-center, Double-blind, Placebo-controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, a Monoacylglycerol Lipase Inhibitor, as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.","conditions":["Progressive Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7268489"},{"type":"DRUG","name":"Ocrelizumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":360,"startDate":"2026-03-10","completionDate":"2028-05-30","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PMS, in accordance with the revised 2017 McDonald criteria\n* Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive\n* Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit\n\nExclusion Criteria:\n\n* MS relapse during the 6 months preceding the randomization date\n* Lack of peripheral venous access\n* History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening\n* Inability to complete a magnetic resonance imaging (MRI)\n* Contraindications to ocrelizumab mandatory pre-medications\n* Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening","locations":[{"facility":"Brain and Mind Centre","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Neurology","city":"Kogarah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Hunter Hospital","city":"New Lambton Heights","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Box Hill Hospital","city":"Box Hill","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Health","city":"Heidelberg","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisas Clinicas - 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https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["camperdown-australia","kogarah-australia","new-lambton-heights-australia","box-hill-australia","heidelberg-australia","s-o-paulo-brazil","strasbourg-france","n-mes-france","bordeaux-france","toulouse-france","montpellier-france","saint-herblain-france","nancy-france","clermont-ferrand-france","bron-france","paris-france","rennes-france","freiburg-im-breisgau-germany","mannheim-germany","t-bingen-germany","ulm-germany","erlangen-germany","munich-germany","frankfurt-am-main-germany","bochum-germany","bonn-germany","d-sseldorf-germany","essen-germany","dresden-germany","leipzig-germany","berlin-germany","hamburg-germany","p-cs-hungary","budapest-hungary","debrecen-hungary","kaposv-r-hungary","chieti-italy","naples-italy","salerno-italy","roma-italy","genoa-italy","milan-italy","pavia-italy","christchurch-central-city-new-zealand","auckland-new-zealand","poznan-poland","rzeszw-poland","katowice-poland","ory-poland","d-poland","bydgoszcz-poland","gda-sk-poland","kielce-poland","krakow-poland","lublin-poland","rzesz-w-poland","warsaw-poland","wroc-aw-poland","zabrze-poland","braga-portugal","coimbra-portugal","lisbon-portugal","santa-maria-da-feira-portugal","lhospitalet-de-llobregat-spain","salt-spain","santiago-de-compostela-spain","lleida-spain","pozuelo-de-alarc-n-spain","el-palmar-spain","vigo-spain","barakaldo-spain","albacete-spain","barcelona-spain","madrid-spain","m-laga-spain","seville-spain","valencia-spain","kocaeli-turkey-t-rkiye","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","konya-turkey-t-rkiye","truro-united-kingdom","london-united-kingdom","glasgow-united-kingdom","cardiff-united-kingdom","salford-united-kingdom","swansea-united-kingdom"],"enrichment":{"headline":"Phase 2: testing RO7268489 for Progressive Multiple Sclerosis","inPlainEnglish":"The main purpose of this study is to assess the how well it works of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the neither you nor the study doctors know who gets the real treatment period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.","whoItsFor":["Ages 18 Years to 60 Years","PMS, in accordance with the revised 2017 McDonald criteria","Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive","Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit"],"whoShouldSkip":["MS relapse during the 6 months preceding the randomization date","Lack of peripheral venous access","History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening","Inability to complete a magnetic resonance imaging (MRI)","Contraindications to ocrelizumab mandatory pre-medications","Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening"],"whatHappens":"If you join, the listed intervention(s) are RO7268489, Ocrelizumab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to assess the how well it works of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 360 people at 114 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.991Z"},{"nctId":"NCT07282613","title":"A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.","conditions":["Diabetes Mellitus, Type 2"],"keywords":[],"interventions":[{"type":"DRUG","name":"CagriSema (Cagrilintide B and Semaglutide I)"},{"type":"DRUG","name":"Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)"}],"enrollment":80,"startDate":"2026-08-04","completionDate":"2029-09-07","sex":"ALL","minAge":"10 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n\n  * The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)\n  * The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)\n* Male or female.\n* Age 10 to \\< 18 years at the time of signing the informed consent.\n* Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \\[ISPAD\\] criteria) ≥ 30 days before screening.\n* Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:\n\n  * Insulin (any regimen)\n  * Metformin\n  * SGLT2i\n* HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.\n* Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.\n\n  * (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening.\n  * (b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used.\n\nKey Exclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.\n* Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.\n* Known or previous diagnosis of hypoparathyroidism.\n* Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \\>1 year before screening, (2) lap banding, if the band has been removed \\>1 year before screening, (3) intragastric balloon, if the balloon has been removed \\>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\> 1 year before screening.\n* Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.\n* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.\n* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.\n* Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.","locations":[{"facility":"Yale School of Medicine","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research Boynton Beach","city":"Boynton Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nemours Chld Clnc Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovus Clinical","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"D&H National Research Centers","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Trials of Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbus Research Foundation","city":"Columbus","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastside Bariatric and Gen Surg","city":"Snellville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SIU Medicine","city":"Springfield","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital For Children","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Research Inst.","city":"Southfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UBMD Pediatrics","city":"Buffalo","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Orthopedic Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hosptl Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Monument Health Clinical Rsrch","city":"Rapid City","state":"South Dakota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"LifeDoc Health","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amir Ali Hassan, MD, PA","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UVA Health Systems","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Research Institute","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Metabólicas","city":"Capital Federal","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio","city":"San Miguel de Tucumán","state":"Tucumán Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMOBA","city":"City of Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIPADI","city":"Godoy Cruz","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clínica Mayo de Urgencias Médicas Cruz Blanca","city":"San Miguel de Tucumán","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitário Walter Cantídio","city":"Bairro Rodolfo Teófilo, Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Diabetes Curitiba","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto da Criança com Diabetes - ICD","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IBTED Tecnologia e Educação em Diabetes - EPP","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto da Criança e do Adolescente do HCFMUSP","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Salud SURA Industriales","city":"Bogotá","state":"Antioquia","country":"Colombia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Valle del Lili","city":"Cali","state":"Valle del Cauca Department","country":"Colombia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Endolife Specialty Hospitals","city":"Guntur","state":"Andhra Pradesh","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"BAPS Pramukh Swami Hospital","city":"Surat","state":"Gujarat","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indira Gandhi Institute of child health","city":"Bangalore","state":"Karnataka","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sir Ganga Ram Hospital","city":"New Delhi","state":"National Capital Territory of Delhi","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Maulana Azad Medical College","city":"Delhi","state":"New Delhi","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Regency Hospital","city":"Kanpur","state":"Uttar Pradesh","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institute of Child Health","city":"Kolkata","state":"West Bengal","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Excel Endocrine Centre","city":"Kolhāpur","state":"","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"All India Institute of Medical Sciences (AIIMS)","city":"New Delhi","state":"","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"HaEmek MC - Pediatric Endocrinology department","city":"Afula","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Soroka MC - Pediatric Endocrinology","city":"Beersheba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam MC - Department of Pediatrics A","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carmel MC - Pediatric Endocrinology Unit","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek MC - Pediatric Endocrinology","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Malaya Medical Centre","city":"Lembah Pantai","state":"Kuala Lumpur","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Putrajaya","city":"Putrajaya","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Pediatría","city":"Coyoacán","state":"Mexico City","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IECSI Centro de Investigación Clínica","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigación y Control Metabólico S. C.","city":"San Nicolás de los Garza","state":"Nuevo León","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UMAE CMN Siglo XXI Dept Endocrinología Pediátrica","city":"Cuauhtémoc","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consultorio de Endocrinología y Pediatría","city":"Puebla City","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taipei Mackay Children's Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"King Chulalongkorn Memorial Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maharaj Nakorn Chiang Mai Hospital_Pediatric Endocrinology","city":"Chiang Mai","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["Change in glycated haemoglobin (HbA1c)"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":["semaglutide"],"locationSlugs":["new-haven-connecticut","boynton-beach-florida","jacksonville-florida","kissimmee-florida","tamarac-florida","tampa-florida","columbus-georgia","snellville-georgia","springfield-illinois","indianapolis-indiana","iowa-city-iowa","southfield-michigan","buffalo-new-york","new-york-new-york","philadelphia-pennsylvania","rapid-city-south-dakota","memphis-tennessee","houston-texas","shavano-park-texas","charlottesville-virginia","seattle-washington","capital-federal-argentina","san-miguel-de-tucum-n-argentina","city-of-buenos-aires-argentina","godoy-cruz-argentina","bairro-rodolfo-te-filo-fortaleza-brazil","curitiba-brazil","porto-alegre-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","bogot-colombia","cali-colombia","guntur-india","surat-india","bangalore-india","new-delhi-india","delhi-india","kanpur-india","kolkata-india","kolh-pur-india","afula-israel","beersheba-israel","haifa-israel","jerusalem-israel","lembah-pantai-malaysia","putrajaya-malaysia","coyoac-n-mexico","monterrey-mexico","san-nicol-s-de-los-garza-mexico","cuauht-moc-mexico","puebla-city-mexico","taipei-taiwan","bangkok-thailand","chiang-mai-thailand"],"enrichment":{"headline":"Phase 3: testing CagriSema (Cagrilintide B and Semaglutide I) for Diabetes Mellitus, Type 2","inPlainEnglish":"The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or dummy treatment (placebo), and in the second part participant will get CagriSema.","whoItsFor":["Ages 10 Years to 18 Years","The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)","Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \\[ISPAD\\] criteria) ≥ 30 days before screening","Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:","Insulin (any regimen)","HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening","Body weight ≥ 45 kg and body-mass index (BMI) ≥ 85th percentile(b). body-mass index (BMI) will be calculated in the electronic case report form based on height and body weight at screening","(b) Based on sex-specific body-mass index (BMI)-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used"],"whoShouldSkip":["Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method","Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the who can join within 90 days before screening","Known or previous diagnosis of hypoparathyroidism","Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history","Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator","Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8"],"whatHappens":"If you join, the listed intervention(s) are CagriSema (Cagrilintide B and Semaglutide I), or Placebo matched to CagriSema (Cagrilintide B and Semaglutide I). The registry lists allocation as randomized. The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 80 people at 58 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.733Z"},{"nctId":"NCT07283939","title":"Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays","officialTitle":"PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alliance for Clinical Trials in Oncology","sponsorClass":"OTHER","summary":"This clinical trial is being done to learn whether using the proactive, graduated dose modification algorithm for leucovorin, 5-fluorouracil (5-FU), and oxaliplatin (FOLFOX) (PAGODA) algorithm to guide chemotherapy dosing for the FOLFOX regimen works to reduce unplanned treatment delays for patients with digestive system cancers compared to usual care. During standard of care treatment, chemotherapy dose changes or treatment delays are typically determined by the treating physician based on factors such as a patient's height, weight, and blood test results obtained before each treatment cycle. If certain blood counts are too low, the next cycle of chemotherapy may be delayed or adjusted. The PAGODA algorithm is a step-by-step decision-making tool designed to help health care providers determine whether chemotherapy doses should be adjusted or delayed in patients with low neutrophil or platelet counts. Researchers will compare treatment delays, dose changes, and safety outcomes between patients managed using the PAGODA algorithm and patients receiving usual care.","conditions":["Ampulla of Vater Carcinoma","Appendix Carcinoma","Carcinoma of Unknown Primary With Gastrointestinal Profile","Colon Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Gastroesophageal Junction Carcinoma","Malignant Digestive System Neoplasm","Rectal Carcinoma","Small Intestinal Carcinoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"PAGODA algorithm"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Folinic Acid"},{"type":"DRUG","name":"Fluorouracil"}],"enrollment":420,"startDate":"2026-02-13","completionDate":"2030-05-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* \\* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n  * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract\n  * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)\n  * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin\n  * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted\n  * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg/m\\^2) and infusional 5-FU (2400 mg/m\\^2/46 hours). Use of the 5-FU bolus is at the discretion of the treating physician\n* Concomitant monoclonal antibodies are permitted during FOLFOX-based chemotherapy (e.g. anti-VEGF, anti-EGFRs, anti-PD1/PDL1, and anti-HER2)\n* Patients receiving concomitant therapy with irinotecan or docetaxel are not eligible\n\n  * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible\n  * Patients with history of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Absolute neutrophil count (ANC) ≥ 1,000/mm\\^3\n  * Platelet count ≥ 100,000/mm\\^3\n  * Total bilirubin ≤ 3 x upper limit of normal (ULN)\n  * AST (SGOT)/ALT (SGPT) ≤ 5 x upper limit of normal (ULN)\n  * Calc. creatinine clearance ≥ 30 mL/min\n  * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration\n  * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration\n  * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy\n  * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II\n  * Patients with a known history of congenital long QT syndrome are ineligible\n  * Patients with known DPD deficiency are ineligible\n* Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency are ineligible\n* \\* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:\n\n  * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study\n  * The non-patient participant must be proficient in the English language\n  * The non-patient participant must be age 21 years or older","locations":[{"facility":"Fairbanks Memorial Hospital","city":"Fairbanks","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center at Saint Joseph's","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Fort Smith","city":"Fort Smith","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CARTI Cancer Center","city":"Little Rock","state":"Arkansas","country":"United 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The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair.\n2. A previously established diagnosis of AD dementia.\n3. The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization\n4. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.\n5. Caregiver who is able and willing to comply with all required study procedures and who is in contact with the participant at least on four individual days for at least two hours per day.\n\nExclusion criteria:\n\n1. The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia.\n2. The participant has symptoms of agitation that are not secondary to AD dementia\n3. The participant has a history of uncontrolled seizures or a history of epilepsy.\n4. The participant has a major medical illness or unstable medical condition","locations":[{"facility":"Esperanza Clinical","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Josephson Wallack Munshower Neurology PC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precise Research Centers","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integrative Clinical Trials","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manhattan Behavioral Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Insight Clinical Trials","city":"Independence","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Memory Clinic","city":"Bennington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"North York","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baycrest Centre for Geriatric Care","city":"North York","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kawartha Centre","city":"Peterborough","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ontario Shores Centre for Mental Health Sciences","city":"Whitby","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Brain-Soultherapy s.r.o.","city":"Kladno","state":"Central Bohemia","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuropsychiatrieHK, sro","city":"Hradec Králové","state":"Hradec Králové Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psychiatrie-Ambulance s.r.o","city":"Pilsen","state":"Plzeň Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"FNUSA - St. Anne's University Hospital Brno","city":"Brno","state":"South Moravian","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medicum Gesundheitszentrum Flugfeld - Praxis Bischof & Secheres","city":"Böblingen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Curiositas ad sanum Studien und Beratungs GmbH","city":"Ebersberg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"TUM Klinikum rechts der Isar","city":"München","state":"Bavaria","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Praxis Dr. med. Kirsten Hahn","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Tor Vergata","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universita degli Studi di Roma ''La Sapienza\" - Azienda Ospedaliera Sant'Andrea","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Cardinale Giovanni Panico","city":"Tricase","state":"Lecce","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli","city":"Brescia","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico - Main Campus","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone","city":"Palermo","state":"Sicily","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Sanitaria Locale (ASL) Chieti - Ospedale Policlinico \"SS Annunziata''","city":"Chieti","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne HCP Sp. z o.o.","city":"Poznan","state":"Greater Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Krakowska Akademia Neurologii","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"NZOZ Wroclawskie Centrum Alzheimerowskie","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureMeds Wroclaw","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"NZOZ Neuromed M. i M. Nastaj Spolka Partnerska","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"RCMed Oddzial Sochaczew","city":"Sochaczew","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Neuroscience Sp. z o.o.","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Silmedic Sp. z o.o.","city":"Katowice","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinhouse Sp. z o.o.","city":"Zabrze","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Staszów","city":"Staszów","state":"Świętokrzyskie Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o.","city":"Banská Bystrica","state":"Banská Bystrica Region","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univerzitna nemocnica Bratislava","city":"Bratislava","state":"Bratislava Kraj","country":"Slovakia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"EPAMED s r.o.","city":"Košice","state":"Košice Region","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crystal Comfort S.R.O.","city":"Vranov nad Topľou","state":"Presov","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medicinske Centrum Konzilium, s.r.o.","city":"Dubnica nad Váhom","state":"Trenčín Region","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de la Macarena","city":"Seville","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Rio Hortega","city":"Valladolid","state":"Castille and León","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Virgen de la Concha","city":"Zamora","state":"Castille and León","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Germans Trias i Pujol","city":"Barcelona","state":"Catalonia","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico San Carlos","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottish Brain Sciences","city":"Edinburgh","state":"Midlothian","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottish Brain Sciences","city":"Aberdeen","state":"North East Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Exciva Clinical Studies","phone":"+49 6221-6479990","email":"studies@exciva.com"}],"primaryOutcomes":["Changes from baseline to endpoint (Week 6) in the Cohen-Mansfield Agitation Inventory - International Psychogeriatric Association (CMAI-IPA) score"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["murrieta-california","indianapolis-indiana","flowood-mississippi","brooklyn-new-york","new-york-new-york","independence-ohio","portland-oregon","bennington-vermont","north-york-canada","peterborough-canada","whitby-canada","kladno-czechia","hradec-kr-lov-czechia","pilsen-czechia","brno-czechia","b-blingen-germany","ebersberg-germany","m-nchen-germany","berlin-germany","rome-italy","tricase-italy","brescia-italy","milan-italy","palermo-italy","chieti-italy","poznan-poland","krakow-poland","wroclaw-poland","lublin-poland","sochaczew-poland","warsaw-poland","katowice-poland","zabrze-poland","stasz-w-poland","bansk-bystrica-slovakia","bratislava-slovakia","ko-ice-slovakia","vranov-nad-top-ou-slovakia","dubnica-nad-v-hom-slovakia","seville-spain","valladolid-spain","zamora-spain","barcelona-spain","madrid-spain","edinburgh-united-kingdom","aberdeen-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing EXV-802 for Agitation Associated With Alzheimer's Disease Dementia","inPlainEnglish":"The goal of this clinical trial is to measure the safety and how well it works of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.","whoItsFor":["Ages 55 Years to 90 Years","The participant is an adult male or female between the ages of 55 to 90 years inclusively, who can move around by themselves, with a walker or a wheelchair","A previously established diagnosis of AD dementia","The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization","The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation"],"whoShouldSkip":["The participant has a confirmed primary diagnosis of a dementia-related disease other than AD dementia","The participant has symptoms of agitation that are not secondary to AD dementia","The participant has a history of uncontrolled seizures or a history of epilepsy","The participant has a major medical illness or unstable medical condition"],"whatHappens":"If you join, the listed intervention(s) are EXV-802, Placebo, or EXV-801. The registry lists allocation as randomized. The goal of this clinical trial is to measure the safety and how well it works of EXV-802 and EXV-801 in treatment of agitation in participants with Alzheimer's Disease dementia.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 300 people at 49 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.327Z"},{"nctId":"NCT07284667","title":"ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response","officialTitle":"A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"ACADIA Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).\n\nThe main questions the study aims to answer are:\n\n* Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression?\n* What adverse events do participants have when taking ACP-211?","conditions":["Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant"],"keywords":["Major Depressive Disorder (MDD)","Depressive Disorder, Treatment-Resistant","Antidepressive Agents","Randomized Controlled Trial","Double-Blind Method","Clinical Trial, Phase II","Psychiatric Status Rating Scales","Ketamine"],"interventions":[{"type":"DRUG","name":"ACP-211"},{"type":"DRUG","name":"Placebo"}],"enrollment":153,"startDate":"2025-11-14","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥18 and ≤65 years of age\n* Provides written informed consent\n* Clinical diagnosis of MDD\n* History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode\n* Currently treated with an approved antidepressant at a stable dose prior to Screening\n* MADRS total score ≥28, CGI-S score ≥4, and QIDS-SR16 score ≥14 at Screening and Baseline\n* Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation\n\nExclusion Criteria:\n\n* Current diagnosis of certain personality disorders or persistent depressive disorder\n* Recent substance use disorders, excluding caffeine or nicotine\n* Active suicidal risk or recent suicidal attempt\n* History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features\n* Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD\n* History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)\n* Allergy or sensitivity to ketamine or esketamine\n* Significant cardiovascular disease\n* Positive history of hepatitis B, hepatitis C, or HIV infection\n* Unstable diabetes or uncontrolled medical conditions\n* Positive urine drug test for an illicit drug or cannabis\n* Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode\n* Recent initiation or change in psychotherapy\n\nAdditional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Behavioral Research Specialists, LLC","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kadima Neuropsychiatry Institute","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PNS Clinical Research LLC dba ATP Clinical Research","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Focus Clinical Research, LLC d/b/a Alliance Clinical West Hills","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mountain View Clinical Research","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Access Research and Medical Services, Inc.","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Medici Medical Research","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sandhill Research, LLC/DBA Accel Research Sites","city":"Largo","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IPTB Clinical Research","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuroscience Research Institute, Inc.","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical, Inc.","city":"Watertown","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitalix Clinical, Inc.","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precise Research Centers","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Charles Psychiatric Associates, Inc. dba Midwest Research Group","city":"Saint Charles","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alivation Research, LLC","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Redbird Research LLC","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Hassman Research Institute, LLC","city":"Marlton","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Integrative Clinical Trials LLC","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Magnolia Clinical Research, LLC","city":"Cary","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Behavioral Clinical Research","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dynamed Clinical Research LP d/b/a DM Clinical Research","city":"Houston","state":"Texas","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Olympus Clinical Research, LLC","city":"Katy","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Family Psychiatry of The Woodlands","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aura Wellness","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sandy Filosi","phone":"+1(609) 250-6920","email":"sfilosi@ACADIA-Pharm.com"},{"name":"Lori Lykens","phone":"+1(609) 250-6917","email":"lori.lykens@acadia-pharm.com"}],"primaryOutcomes":["Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["birmingham-alabama","chino-california","glendale-california","la-jolla-california","orange-california","west-hills-california","denver-colorado","fort-myers-florida","hollywood-florida","largo-florida","orlando-florida","tampa-florida","west-palm-beach-florida","watertown-massachusetts","worcester-massachusetts","flowood-mississippi","saint-charles-missouri","lincoln-nebraska","las-vegas-nevada","marlton-new-jersey","brooklyn-new-york","cary-north-carolina","north-canton-ohio","houston-texas","katy-texas","the-woodlands-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 2: testing ACP-211 for Major Depressive Disorder (MDD)","inPlainEnglish":"The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (major depression) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a dummy treatment (placebo) (a look-alike capsule with no medicine) to reduce symptoms of depression?","whoItsFor":["Ages 18 Years to 65 Years","Adults ≥18 and ≤65 years of age","Clinical diagnosis of major depression","History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode","Currently treated with an approved antidepressant at a stable dose prior to Screening","MADRS total score ≥28, CGI-S score ≥4, and QIDS-SR16 score ≥14 at Screening and Baseline","Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation"],"whoShouldSkip":["Current diagnosis of certain personality disorders or persistent depressive disorder","Recent substance use disorders, excluding caffeine or nicotine","Active suicidal risk or recent suicidal attempt","History of schizophrenia, psychotic disorders, bipolar disorder, or major depression with psychotic features","Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD","History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)","Allergy or sensitivity to ketamine or esketamine"],"whatHappens":"If you join, the listed intervention(s) are ACP-211, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (major depression) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 153 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.110Z"},{"nctId":"NCT07284745","title":"A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism","officialTitle":"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.","conditions":["Irritability Associated With Autism Spectrum Disorder"],"keywords":["Cobenfy","Autism Spectrum Disorder"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"DRUG","name":"KarX-EC"},{"type":"DRUG","name":"KarXT + KarX-EC Matching Placebo"}],"enrollment":176,"startDate":"2026-10-06","completionDate":"2029-08-06","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Local Institution - 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The registry lists allocation as randomized. This study wants to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 176 people at 41 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.795Z"},{"nctId":"NCT07285135","title":"Dietary Glycine Supplementation in Metabolic Dysfunction-associated Steatotic Liver Disease","officialTitle":"Investigating the Effects of Dietary Glycine Supplementation in Patients With Metabolic Dysfunction-associated Steatotic Liver Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Singapore General Hospital","sponsorClass":"OTHER","summary":"This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function.\n\nThe study consists of two components. The first is a cross-sectional case-control study comparing urinary acylglycine concentrations and other glycine-dependent metabolic parameters between 60 participants with MASLD and 30 healthy controls. The second is a randomized, double-blind, placebo-controlled trial in which 60 participants with MASLD will receive either oral glycine supplementation (9 g/day) or placebo for 26 weeks.\n\nThe primary outcomes are differences in urinary acylglycine concentrations between participants with MASLD and healthy controls, and changes in hepatic fat content measured by MRI-PDFF and urinary acylglycine concentrations following supplementation. Additional assessments will evaluate amino acid metabolism, glutathione metabolism, oxidative stress, inflammatory responses, and one-carbon metabolism-related biomarkers. Participants will undergo baseline, Week 12, and Week 26 assessments to evaluate metabolic changes and treatment responses.","conditions":["Metabolic Dysfunction Associated Fatty Liver Disease"],"keywords":["Fatty liver","Randomized controlled trial","glycine supplements"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Glycine"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":90,"startDate":"2025-11-01","completionDate":"2028-07","sex":"ALL","minAge":"21 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAll subjects:\n\n1. Age 21-70 years\n2. Ability to provide informed consent.\n\nMASLD group:\n\n1. Hepatic steatosis on MRI\n2. BMI of 25-50 kg/m2\n\nControls:\n\n1. Absence of hepatic steatosis on MRI\n2. BMI of 18.5-24.9 kg/m2\n3. No chronic disease\n4. No long-term medications\n\nExclusion Criteria:\n\n1. Uncontrolled diabetes (HbA1c \\> 8%)\n2. Type 1 Diabetes Mellitus\n3. Clinically significant anemia (Haemoglobin \\< 10 g/dL)\n4. Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis\n5. Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)\n6. Glomerular filtration rate (GFR \\< 30 ml/min)\n7. Serum alanine transaminase (ALT) \\> 3x upper limit of normal (ULN)\n8. Serum aspartate transaminase (AST) \\> 3x ULN\n9. Liver cirrhosis\n10. Significant alcohol consumption (\\> 20g/day for women and \\>30g/day for men)\n11. Pregnancy\n12. Uncontrolled thyroid disease\n13. Previous bariatric surgery\n14. Weight loss \\> 5% in the past 1 month\n15. Metallic implants (including incompatible pacemakers, AICD, metallic heart valves) or other contraindications to MRI\n16. Claustrophobia\n17. Any factors likely to limit adherence to study protocol (e.g., dementia; alcohol or substance abuse; history of unreliability in medication taking or appointment keeping; significant concerns about participation in the study from spouse, significant other, or family members)","locations":[{"facility":"Singapore General Hospital","city":"Singapore","state":"Singapore","country":"Singapore","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hong Chang Tan, MD PhD","phone":"+65 63214658","email":"tan.hong.chang@singhealth.com.sg"}],"primaryOutcomes":["Difference in urinary acylglycine concentrations between MASLD participants and healthy controls","Change in hepatic proton density fat fraction (MRI-PDFF) from baseline to 26 weeks","Changes in urinary acylglycine concentrations following dietary glycine supplementation."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["singapore-singapore"],"enrichment":{"headline":"Not a traditional drug phase: Glycine for Metabolic Dysfunction Associated Fatty Liver Disease","inPlainEnglish":"This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function. The first is a cross-sectional case-control study comparing urinary acylglycine concentrations and other glycine-dependent metabolic parameters between 60 participants with MASLD and 30 healthy controls.","whoItsFor":["Ages 21 Years to 70 Years","Hepatic steatosis on MRI","Absence of hepatic steatosis on MRI","body-mass index (BMI) of 18.5-24.9 kg/m2","No long-term medications"],"whoShouldSkip":["Uncontrolled diabetes (HbA1c \\> 8%)","Type 1 Diabetes Mellitus","Clinically significant anemia (Haemoglobin \\< 10 g/dL)","Chronic liver disorders (except MASLD) such as Hepatitis B, Hepatitis C, Wilson's disease, hemochromatosis, autoimmune hepatitis, chronic cholestatic disorders, and liver cirrhosis","Drugs that may induce hepatic steatosis, such as methotrexate, amiodarone, tamoxifen, or Systemic steroid usage (eg. prednisolone, hydrocortisone, cortisone, dexamethasone)","Glomerular filtration rate (GFR \\< 30 ml/min)","Serum alanine transaminase (ALT) \\> 3x upper limit of normal (ULN)"],"whatHappens":"If you join, the listed intervention(s) are Glycine, or Placebo. The registry lists allocation as randomized. This study aims to investigate abnormalities in glycine-dependent metabolic pathways in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and evaluate whether dietary glycine supplementation improves liver health and metabolic function.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Singapore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.152Z"},{"nctId":"NCT07285213","title":"Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody","officialTitle":"A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides Difficile Infection in Individuals 18 Years of Age and Above","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.","conditions":["Clostridioides Difficile Infection"],"keywords":["Clostridioides Difficile infection","C. Diff","CDiff","Clostridiodes Difficile Infection prevention of recurrence"],"interventions":[{"type":"DRUG","name":"AZD5148"},{"type":"OTHER","name":"Placebo"}],"enrollment":230,"startDate":"2025-12-10","completionDate":"2027-04-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipant must be ≥ 18 years of age at the time of signing the informed consent, capable of giving signed informed consent.\n\nParticipants with a qualifying C. difficile infection episode at the time of providing informed consent defined by:\n\n* History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days, (Note: Diarrhea is not required to be present on the day of IMP administration) and\n* Positive local C. difficile toxin test (eg, immune assay or CCNA) on a stool sample collected during this episode, as part of routine clinical care (Note: Toxin testing, where not part of routine clinical care, may be conducted as a pre- screening activity; if this occurs, participant consent is required), and\n* Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode,\n\nNote: At the time of randomization and IMP administration, the participant must have started receiving the antibacterial drug therapy with a planned total treatment duration of at least 10 and at most 28 days at time of IMP administration. IMP can be administered at any point during the antibacterial drug therapy.\n\nBody weight ≥ 35 kg\n\nExclusion Criteria:\n\nParticipants with a history of uncontrolled inflammatory bowel disease. Participants with a history of inflammatory bowel disease may be included if, in the opinion of the Investigator, their disease is clinically controlled and presenting symptoms are more likely attributable to CDI than to a flare of inflammatory bowel disease.\n\nParticipants with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)\n\nPlanned surgery for C. difficile infection within 24 hours of enrollment\n\nCurrent toxic megacolon and/or small bowel ileus\n\nAny history of total colectomy\n\nMajor gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)\n\nDue to receive more than 28 days of antibacterial drug therapy for the qualifying C. difficile infection episode\n\nParticipants receiving a fecal microbiota transplant, fecal microbiota product, or live biotherapeutic product for the qualifying CDI episode, or planned administration during the 180 days after IMP administration.\n\nTreatment with bezlotoxumab in the 180 days before IMP administration, are receiving or planned administration for the qualifying episode of CDI, or planned administration during the 180 days after IMP administration.","locations":[{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Chula Vista","state":"California","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hamden","state":"Connecticut","country":"United 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Site","city":"Newcastle","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["First occurrence of recurrence of C difficile infection"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","chula-vista-california","sacramento-california","torrance-california","hamden-connecticut","gainesville-florida","hialeah-florida","homestead-florida","jacksonville-florida","miami-lakes-florida","miramar-florida","port-orange-florida","tamarac-florida","tampa-florida","athens-georgia","atlanta-georgia","idaho-falls-idaho","burr-ridge-illinois","lexington-kentucky","louisville-kentucky","new-orleans-louisiana","glen-burnie-maryland","potomac-maryland","boston-massachusetts","detroit-michigan","royal-oak-michigan","columbia-missouri","kansas-city-missouri","st-louis-missouri","union-city-new-jersey","hartsdale-new-york","inwood-new-york","the-bronx-new-york","salisbury-north-carolina","winston-salem-north-carolina","pittsburgh-pennsylvania","johnson-city-tennessee","charlottesville-virginia","lynchburg-virginia","roanoke-virginia","seattle-washington","madison-wisconsin","camperdown-australia","clayton-australia","herston-australia","melbourne-australia","south-brisbane-australia","edmonton-canada","vancouver-canada","victoria-canada","halifax-canada","hamilton-canada","london-canada","montreal-canada","qu-bec-canada","sherbrooke-canada","aarhus-n-denmark","gistrup-denmark","hvidovre-denmark","k-benhavn-denmark","odense-c-denmark","lyon-france","montpellier-france","nantes-france","n-mes-france","paris-france","tours-france","augsburg-germany","berlin-germany","cologne-germany","frankfurt-germany","hamburg-germany","jena-germany","leipzig-germany","m-nchen-germany","athens-greece","heraklion-greece","ioannina-greece","thessaloniki-greece","budapest-hungary","debrecen-hungary","eger-hungary","kistarcsa-hungary","p-cs-hungary","modena-italy","naples-italy","palermo-italy","pisa-italy","roma-italy","varese-italy","kochi-japan","kumamoto-japan","meguro-ku-japan","nagasaki-japan","shimonoseki-shi-japan","yaizu-shi-japan","lublin-poland","warsaw-poland","alicante-spain","badalona-spain","madrid-spain","majadahonda-spain","seville-spain","helsingborg-sweden","lund-sweden","malm-sweden","v-ster-s-sweden","birmingham-united-kingdom","cambridge-united-kingdom","cardiff-united-kingdom","newcastle-united-kingdom"],"enrichment":{"headline":"Phase 2: testing AZD5148 for Clostridioides Difficile Infection","inPlainEnglish":"This study wants to measure the how well it works and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.","whoItsFor":["Ages 18 Years to any","History of 3 or more unformed stools (Bristol stool scale 6 or 7) in ≤ 24 hours for 2 consecutive calendar days, (Note: Diarrhea is not required to be present on the day of IMP administration) and","Planned initiation or receipt of antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode,","Body weight ≥ 35 kg"],"whoShouldSkip":["Participants with a non - CDI (C. difficile infection) condition such that the participant routinely passes loose stool (eg, patients with an ostomy)","Planned surgery for C. difficile infection within 24 hours of enrollment","Current toxic megacolon and/or small bowel ileus","Any history of total colectomy","Major gastrointestinal surgery as assessed by the Investigator (eg, significant bowel resection or diversion) within 90 days before enrollment (this does not include appendectomy or cholecystectomy)","Due to receive more than 28 days of antibacterial drug therapy for the qualifying C. difficile infection episode","Participants receiving a fecal microbiota transplant, fecal microbiota product, or live biotherapeutic product for the qualifying CDI episode, or planned administration during the 180 days after IMP administration"],"whatHappens":"If you join, the listed intervention(s) are AZD5148, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 230 people at 111 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.450Z"},{"nctId":"NCT07285239","title":"Belantamab Mafodotin or Daratumumab With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","officialTitle":"Randomized Phase 3 Trial of Belantamab Mafodotin or Daratumumab in Combination With Bortezomib, Lenalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"PrECOG, LLC.","sponsorClass":"OTHER","summary":"Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. Participants will be randomized to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.\n\nBelantamab mafodotin is a targeted cancer treatment that works against multiple myeloma cells. It combines a homing device (an antibody) with a powerful cell-killing drug (a toxin), delivering the toxin directly to cancer cells while largely sparing healthy cells.\n\nMinimal residual disease (MRD) testing will be done on bone marrow samples obtained standardly during your treatment. MRD shows whether a very small number of cancer cells can still be detected after treatment, even if standard lab tests shows no signs of cancer.\n\nThe purpose of this study is to evaluate if belantamab mafodotin, bortezomib, lenalidomide and dexamethasone (BVRd) improves minimal residual disease (MRD) negative status and/or prolongs progression-free survival (PFS) compared with daratumumab, bortezomib, lenalidomide and dexamethasone (DVRd) in participants with newly diagnosed multiple myeloma.","conditions":["Multiple Myeloma"],"keywords":["Newly Diagnosed High-Risk Multiple Myeloma","Transplant Ineligible Multiple Myeloma","High-Risk Cytogenetic Multiple Myeloma","Belantamab Mafodotin","Daratumumab-Hyaluronidase","Daratumumab","Bortezomib","Lenalidomide","Decadron","Dexamethasone"],"interventions":[{"type":"DRUG","name":"Arm A: Belantamab Mafodotin"},{"type":"DRUG","name":"Arm B: Daratumumab Hyaluronidase"},{"type":"DRUG","name":"Bortezomib"},{"type":"DRUG","name":"Lenalidomide"},{"type":"DRUG","name":"Dexamethasone"}],"enrollment":500,"startDate":"2026-12","completionDate":"2031-11","sex":"ALL","minAge":"18 Years","maxAge":"79 Years","healthyVolunteers":false,"eligibilityRaw":"Eligibility Criteria:\n\n* Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of any myeloma treatment.\n* Patient must be considered ineligible for autologous stem cell transplantation by the treating physician because of their age (≥ 70 years) or aged 18 - 70 years with the presence of underlying medical conditions likely to have a negative impact on tolerability of high-dose chemotherapy with stem-cell transplantation, making them transplant ineligible, OR transplant-eligible and refusing stem-cell transplantation until first relapse or later.\n* Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization.\n\n  * ≥ 1g/dL monoclonal protein (M-protein) on serum protein electrophoresis\n  * Involved free light chain ≥ 10 mg/dL or ≥ 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\<0.26 or \\>1.65)\n  * ≥ 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis\n  * Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)\n* Patient must be ≥ 18 years and \\<80 years of age.\n* Patient must have an Eastern Cooperative Group (ECOG) Performance Status (PS) of 0-2 (PS 3 allowed if secondary to pain).\n* Patient must have IMWG Frailty Score \\<2.\n* Patient must have the ability to understand and willingness to sign a written informed consent document.\n* Patient must be willing to provide bone marrow (aspirate and/or biopsy) and blood samples for determination of International Myeloma Society (IMS) risk status and for research. Indeterminate patients with missing or unevaluable samples will be excluded.\n* Patient must have received no more than one cycle (28 days or less) of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma. Prior radiation therapy to symptomatic lesions is allowed provided there is no residual toxicity related to radiation and blood counts meet the study requirements. NOTE: Patients who have received prior treatment for smoldering multiple myeloma (SMM) are eligible.\n* Patient must have a Serum Protein Electrophoresis (SPEP), Urine Protein Electrophoresis (UPEP), and serum Free Light Chain (FLC) assay performed within 28 days prior to registration. In addition, a bone marrow biopsy and/or aspirate is required within 28 days prior to registration if measurable disease is only present in bone marrow. Otherwise, a bone marrow examination must have been performed within 90 days prior to registration.\n* Patient must have adequate organ function and marrow function as defined below, obtained ≤ 2 weeks prior to registration.\n\n  * Absolute Neutrophil Count (ANC) ≥ 1000/microliter (mcL)\n  * Platelets ˃75,000/mcL\n  * Creatinine clearance (CrCl) ≥ 30 mL/min\n  * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3x upper limit of normal (ULN)\n  * Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with documented Gilbert's disease\n* Patient must agree to register to the mandatory lenalidomide (Revlimid) Risk Evaluation and Mitigation Strategy (REMS) program and be willing and able to comply with the requirements of the REMS program.\n* Patient must not be pregnant or breast-feeding due to the potential harm and teratogenic effects to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.\n* Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 3 months after the last dose of protocol treatment.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patient must be class 2 or better.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients must not have peripheral neuropathy ≥ Grade 2 on clinical examination or Grade 1 with pain at time of registration.\n* Patients must not have any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\n* Patient may have a history of current or previous deep vein thrombosis (DVT) or pulmonary embolism (PE) but must be willing to take some form of anti-coagulation as prophylaxis if they are not currently on full-dose anticoagulation.\n* Patients must not have any known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients, or known sensitivity to mammalian-derived products.\n* Patients must not have current corneal epithelial disease except mild punctuate keratopathy.\n* Contact lenses must be avoided for participants while they are receiving belantamab mafodotin treatment unless cleared by an eye-care specialist. If cleared for use, bandaged contact lenses are specifically recommended. Contact lens use may be restarted after discontinuation of belantamab mafodotin treatment, provided the eye-care specialist confirms there are no other contraindications.\n* Patients must not have symptomatic amyloidosis or active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasma-proliferative disorder, skin changes) at the time of screening.\n* Patients must not receive any other concurrent chemotherapy, or any ancillary therapy considered investigational while on this protocol.","locations":[{"facility":"Gundersen Lutheran","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael Wright, MS","phone":"267-319-3910","email":"PrE1005@precogllc.org"}],"primaryOutcomes":["MRD Negative Status","Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["la-crosse-wisconsin"],"enrichment":{"headline":"Phase 3: testing Arm A: Belantamab Mafodotin for Multiple Myeloma","inPlainEnglish":"Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled. you would be randomly assigned to either belantamab mafodotin or daratumumab given in combination with bortezomib, lenalidomide and dexamethasone.","whoItsFor":["Ages 18 Years to 79 Years","Eligibility Criteria:","Patient must have suspected or confirmed newly diagnosed multiple myeloma (MM) by International Myeloma Working Group (IMWG) criteria and must not have received more than one cycle of any myeloma treatment","Patient must have measurable or evaluable disease as defined by having one or more of the following, obtained within 28 days prior to randomization","≥ 1g/dL monoclonal protein (M-protein) on serum protein electrophoresis","Involved free light chain ≥ 10 mg/dL or ≥ 100 mg/L AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (\\<0.26 or \\>1.65)","≥ 200 mg/24 hours of monoclonal protein on a 24-hour urine protein electrophoresis","Monoclonal bone marrow plasmacytosis ≥ 30% (evaluable disease)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Arm A: Belantamab Mafodotin, Arm B: Daratumumab Hyaluronidase, or Bortezomib. The registry lists allocation as randomized. Eligible participants with newly diagnosed myeloma who are not considered eligible or refuse bone marrow transplant will be enrolled.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 500 people at La Crosse. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.488Z"},{"nctId":"NCT07285798","title":"A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder","officialTitle":"A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.","conditions":["Irritability Associated With Autism Spectrum Disorder"],"keywords":["Autism Spectrum Disorder"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"DRUG","name":"KarX-EC"},{"type":"DRUG","name":"KarXT + KarX-EC Matching Placebo"}],"enrollment":176,"startDate":"2026-10-06","completionDate":"2029-08-06","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.\n* Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).\n\nExclusion Criteria\n\n* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).\n* Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.\n* Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.\n* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.\n* Other protocol-defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Local Institution - 0062","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cortica - Glendale","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0117","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0126","city":"Orange","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0132","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0115","city":"San Juan Capistrano","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cortica - Marin","city":"San Rafael","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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C.","city":"Guadalajara","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"B&B Investigaciones Medicas S.C.","city":"Mazatlán","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigación Clinica Chapultepec","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ketamine Clinic México","city":"Mexico City","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Care and Research SA de CV","city":"Mérida","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigacion Clinica Chapultepec","city":"Morelia","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCB Research Center","city":"Bayamón","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Time to Relapse Defined as Days from Randomization to the Date on Which the Participant Meets Any Relapse Criterion"],"hasResults":false,"conditionSlugs":["bipolar-disorder"],"drugSlugs":[],"locationSlugs":["orange-california","new-haven-connecticut","hialeah-florida","maitland-florida","miami-lakes-florida","naples-florida","orlando-florida","weston-florida","atlanta-georgia","waterloo-iowa","gaithersburg-maryland","springfield-massachusetts","watertown-massachusetts","philadelphia-pennsylvania","mckinney-texas","richardson-texas","clinton-utah","fairfax-virginia","bellevue-washington","abb-argentina","buenos-aires-argentina","c-rdoba-argentina","la-plata-argentina","mendoza-argentina","rosario-argentina","santiago-del-estero-argentina","bras-lia-brazil","campinas-brazil","mar-lia-brazil","rio-de-janeiro-brazil","s-o-bernardo-do-campo-brazil","s-o-paulo-brazil","valinhos-brazil","changsha-china","hangzhou-china","huzhou-china","jinan-china","shanghai-china","shijiazhuang-china","tianjin-china","xiamen-china","zhumadian-china","belgavi-india","bhopal-india","chhatrapati-sambhajinagar-india","dehradun-india","dharwad-india","lucknow-india","mysore-india","nashik-india","pune-india","tiruchirappalli-india","varanasi-india","chikugo-japan","chiyoda-city-japan","fukushima-japan","iruma-japan","karatsu-japan","k-t-city-japan","kumamoto-japan","kure-japan","kurume-japan","sagamihara-japan","shibuya-ku-japan","tokyo-japan","toshima-city-japan","yamagata-japan","yokohama-japan","chihuahua-city-mexico","guadalajara-mexico","mazatl-n-mexico","mexico-city-mexico","m-rida-mexico","morelia-mexico","bayam-n-puerto-rico"],"enrichment":{"headline":"Phase 2: testing Brenipatide for Bipolar Disorder","inPlainEnglish":"This study wants to assess the how well it works and safety of brenipatide when administered with standard of care (SoC), compared with dummy treatment (placebo) plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months.","whoItsFor":["Ages 18 Years to 75 Years","Meet the diagnostic criteria for bipolar disorder I or bipolar disorder II","Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as","self-inject study intervention","store and use the provided blinded study intervention, as directed","maintain electronic and paper study diaries, as applicable, and","complete the required questionnaires","Are on stable standard of care medication for bipolar disorder"],"whoShouldSkip":["Have a lifetime history or current diagnosis of the following according to DSM-5 criteria:","schizophrenia or other psychotic disorder","borderline personality disorder, or","any eating disorder","Have type 1 diabetes mellitus, or a history of","hyperosmolar state or coma","Have evidence of moderate or severe substance or alcohol use disorder within the past 180 days prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Brenipatide, or Placebo. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of brenipatide when administered with standard of care (SoC), compared with dummy treatment (placebo) plus SoC in delaying the worsening of bipolar disorder symptoms.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 400 people at 87 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.729Z"},{"nctId":"NCT07286331","title":"A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)","officialTitle":"A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.","conditions":["Neoplasms, Endometrial"],"keywords":["Endometrial Cancer","Mocertatug rezetecan","Mo-Rez","GSK5733584","Paclitaxel","Doxorubicin","Antibody-drug conjugate","BEHOLD-Endometrial01"],"interventions":[{"type":"DRUG","name":"Mocertatug rezetecan"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Doxorubicin"}],"enrollment":600,"startDate":"2026-06-04","completionDate":"2028-02-29","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has histologically confirmed endometrial carcinoma including but not limited to endometroid, serous, clear cell, and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted.\n* Has undergone at least 1 and no more than 2 lines of prior systemic treatment for EC. Up to 3 lines of prior systemic treatment are acceptable if one line was administered in the adjuvant/neo-adjuvant setting. The definition of prior lines of therapy is as follows:\n\n  * Adjuvant ± neo-adjuvant therapy counts as one line of treatment.\n  * Maintenance therapy is considered part of the preceding line and does not count as an independent line.\n  * Switching to another agent within the same class due to toxicity (without disease progression) is considered part of the same line of therapy.\n  * Unplanned addition or switching to a new anti-cancer therapy in a different class is considered a separate line of therapy.\n  * Hormonal therapy is NOT counted as a separate line.\n* Must have progressed on or after prior platinum-based chemotherapy and have received anti- Programmed cell death 1 (PD-1) /anti- Programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination. Participants deemed unsuitable for a prior PD-1/PD-L1 inhibitor therapy (contraindications such as immunodeficiency, autoimmune disease that required systemic treatment) as determined by the investigator or treating physician are eligible.\n* Participants must have a platinum-free interval of less than 12 months if they previously received platinum-based therapy solely in the adjuvant setting. The platinum-free interval is defined as the date of the last dose of platinum-based chemotherapy to the date of disease progression.\n\n  * If PD-L1/PD-1 inhibitor therapy was administered with platinum-based treatment, participant is eligible regardless of whether the Platinum-free interval (PFI) exceeds 12 months.\n  * Participants with metastatic disease who underwent treatment including gynecological surgery followed by a platinum-based regimen, or those deemed intolerant to platinum-based therapy, are eligible regardless of whether the PFI exceeds 12 months.\n* Has provided a Formalin-fixed, paraffin-embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression, with the result of B7-H4 expression testing available prior to date of randomization.\n* Has ≥1 Target Lesion per RECIST 1.1 by BICR eligibility review of screening scans.\n* Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:\n\n  * Is a Participant of non-childbearing potential (PONCBP) OR\n  * Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective (with a failure rate of \\<1% per year), with low user dependency, 30 days prior to Cycle 1 Day 1 (C1D1) and during the study intervention period and for at least 8 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention\n\n  * If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n  * Additional requirements for pregnancy testing during and after study intervention are described in protocol.\n  * The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a participant with an early undetected pregnancy.\n* Is capable of giving signed informed consent including compliance with the requirements and restrictions listed in the ICF and in the protocol.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within the past 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \\[e.g., breast, cervix, bladder\\] that have been resected with no evidence of metastatic disease, or that is otherwise considered cured by the investigator.\n* Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.\n* Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.\n* Has untreated brain or Central nervous system (CNS) metastases or brain/CNS metastases that have progressed (e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases). Participants with previously treated and clinically stable brain/CNS metastases and who have completed all corticosteroid therapy for ≥14 days before date of C1D1 are not excluded from participation.\n* Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has ongoing adverse reaction(s) from prior therapy that has (have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo and endocrinopathy managed with replacement therapy, or that the investigator, with the agreement of the sponsor, considers to be stable or not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has any serious and/or unstable medical condition (including infection) or any serious and/or unstable psychiatric disorder or other condition(s) (including laboratory assessment abnormalities) that could interfere with the participant's safety, obtainment of informed consent, or compliance to the study procedures.\n* Has had any major surgery within 28 days prior to date of C1D1 or history of local radiotherapy within 21 days prior to C1D1.\n* Has received treatment with an investigational agent within 30 days prior to C1D1.\n* Has received prior therapy with Topo1i (e.g. irinotecan or topotecan) or ADC with a Topo1i payload, or B7-H4 targeted therapy.\n* Has received treatment with any cytotoxic chemotherapy drugs or other antitumor drugs (including endocrine therapy, molecular targeted therapy, immunotherapy, biotherapy and investigational drug) within 30 days or 5 half-lives, whichever is shorter, prior to C1D1; or need to continue these drugs during the study.\n* Has received any live vaccine within 30 days prior to C1D1.Note: mRNA and adenoviral-based Coronavirus disease 2019 (COVID-19) vaccines are considered non-live.\n* Has received treatment with inhibitors of P-glycoprotein (P-gp), Breast cancer resistant protein (BCRP), or OATP1B1/1B3 transporters within 7 days prior to first dose of study drug. P-gp inducers should be discontinued for at least 14 days before the start of the study drug.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte colony stimulating factor (G-CSF), Granulocyte-macrophage colony stimulating factor (GM-CSF), or recombinant erythropoietin) within 14 days prior to C1D1.\n* Has a known Human immunodeficiency virus (HIV) infection AND meets at least 1 of the following criteria:\n\n  * Has documented evidence of plasma HIV-1 Ribonucleic acid (RNA) ≥50 c/mL within 3 months prior to or at screening. In the 3 to 12 months prior to screening, plasma HIV1 RNA levels consistently \\<50 c/mL are required for enrollment; if multiple instances of plasma HIV-1 RNA values ≥50 c/mL occurred in the 3 to 12 months prior to screening, the participant is not eligible for enrollment unless, per the investigator's assessment, the elevations were neither persistent nor associated with antiretroviral resistance; OR\n  * Has not had Cluster of differentiation (CD)4 cell counts measured in the past 12 months (i.e., at least 2 separate measurements taken a minimum of 28 days apart, 1 of which must be conducted at screening); OR\n  * Has had any CD4 cell count values ≤350 cells/mm3 in the past 12 months. OR\n  * Has had 1 or more changes in their combination antiretroviral therapy regimen or has received an antiretroviral therapy regimen that is inconsistent with locally recommended guidelines during the 3 months prior to screening; OR\n  * Has a history of HIV-associated non-Hodgkin lymphoma within 5 years prior to screening or a history of HIV-associated invasive cervical cancer; OR\n  * Has received treatment with an HIV1 immunotherapeutic vaccine within 90 days prior to screening.\n* Has an Alanine aminotransferase (ALT) value \\>2.5× Upper limit of normal (ULN) and/or for participants documented liver metastases/tumor infiltration has an ALT value \\>5x ULN\n* Has a total bilirubin value \\>1.5x ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice.\n* Has documented presence of Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) at screening unless they meet both the following criteria:\n\n  * Participants with chronic Hepatitis B virus (HBV) infection (HBsAg+) or positive HBcAb are required to be receiving effective antiviral therapy (i.e., with nucleos(t)ide analogs \\[Tenofovir or Entecavir\\]) for at least 14 days prior to C1D1 and are willing to continue for at least 6 months after treatment discontinuation or longer at the discretion of the treating hepatologist.\n  * HBV Deoxyribonucleic acid (DNA) must be adequately suppressed, as per institutional or local guidelines, prior to initiation of study intervention.\n* Has a positive Hepatitis C virus (HCV) antibody test result at screening or within 3 months prior to C1D1 unless HCV RNA is negative, indicating past resolved HCV infection, including participants who have undergone curative treatment.\n* Has a positive HCV RNA test result at screening or within 3 months prior to C1D1.\n* Has QTc \\>470 milliseconds (msec)\n* Has a history within 12 months prior to screening of clinically significant or uncontrolled cardiac disease, acute myocardial infarction, New York Heart Association Class III or IV congestive heart failure \\[NYHA 1994\\], or clinically significant arrhythmia not controlled by standard of care therapy.\n* Has Left ventricular ejection fraction (LVEF) \\<50% or less than institutional lower limit of normal.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).","locations":[{"facility":"GSK Investigational Site","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Sugar Land","state":"Texas","country":"United 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Site","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Vitória","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Kfar Saba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Aichi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational 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Site","city":"Okayama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Okinawa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Saitama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Shizuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Panama City","state":"","country":"Panama","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Cheongju Chungcheongbuk-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Seongnam-si Gyeonggi-do","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Objective response rate (ORR) by BICR","Progression Free Survival (PFS) by BICR"],"hasResults":false,"conditionSlugs":["endometrial-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","omaha-nebraska","sugar-land-texas","charlottesville-virginia","florida-argentina","mendoza-argentina","buenos-aires-argentina","ciudad-autonoma-de-buenos-aire-argentina","c-rdoba-argentina","rosario-argentina","dubbo-australia","auchenflower-australia","herston-australia","s-o-lu-s-brazil","curitibapr-brazil","porto-alegre-brazil","s-o-paulo-brazil","vit-ria-brazil","toronto-canada","montreal-canada","haifa-israel","kfar-saba-israel","aichi-japan","fukuoka-japan","hokkaido-japan","hy-go-japan","kanagawa-japan","kyoto-japan","mie-japan","numakunai-japan","okayama-japan","okinawa-japan","osaka-japan","saitama-japan","shizuoka-japan","tokyo-japan","panama-city-panama","cheongju-chungcheongbuk-do-south-korea","daegu-south-korea","seongnam-si-gyeonggi-do-south-korea","seoul-south-korea","sutton-united-kingdom","leicester-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Mocertatug rezetecan for Neoplasms, Endometrial","inPlainEnglish":"This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care. The study also assesses whether Mo-Rez is safe and tolerated well by participants in comparison to standard of care and will help provide a better understanding of the main side effects of the drugs.","whoItsFor":["Ages 18 Years to any","Women only","Participants are eligible to be included in the study only if all of the following criteria apply:","Has histologically confirmed endometrial carcinoma including but not limited to endometroid, serous, clear cell, and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted","Has undergone at least 1 and no more than 2 lines of prior systemic treatment for EC. Up to 3 lines of prior systemic treatment are acceptable if one line was administered in the adjuvant/neo-adjuvant setting. The definition of prior lines of therapy is as follows:","Adjuvant ± neo-adjuvant therapy counts as one line of treatment","Maintenance therapy is considered part of the preceding line and does not count as an independent line","Switching to another agent within the same class due to toxicity (without disease progression) is considered part of the same line of therapy","Unplanned addition or switching to a new anti-cancer therapy in a different class is considered a separate line of therapy"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer","Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant","Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study","Has any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis","Has had any major surgery within 28 days prior to date of C1D1 or history of local radiotherapy within 21 days prior to C1D1","Has received treatment with an investigational agent within 30 days prior to C1D1"],"whatHappens":"If you join, the listed intervention(s) are Mocertatug rezetecan, Paclitaxel, or Doxorubicin. The registry lists allocation as randomized. This study specifically aims to evaluate how well mocertatug rezetecan (Mo-Rez) works in treating Endometrial Cancer (EC) compared to standard of care.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.701Z"},{"nctId":"NCT07286578","title":"A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)","officialTitle":"A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fundación EPIC","sponsorClass":"OTHER","summary":"The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.","conditions":["Cardiovascular Diseases","Myocardial Ischemia","Heart Diseases","Arteriosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Coronary Artery Disease"],"keywords":["IVUS","CT"],"interventions":[{"type":"DEVICE","name":"CT(Computed Tomography) guided Percutaneous Coronary Intervention"},{"type":"DEVICE","name":"IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention"}],"enrollment":700,"startDate":"2025-12-22","completionDate":"2029-12-15","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The subject must be at least 18 years of age and younger than 85 years old\n* Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression\\>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score\\>140.\n* All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm\n* Subject must provide written informed consent before any study-related procedure\n\nExclusion Criteria:\n\n* STEMI as the clinical presentation.\n* Uncontrolled or recurrent ventricular tachycardia.\n* Hemodynamic instability.\n* Hemodialysis or peritoneal dialysis.\n* Left main coronary artery stenosis \\> 50%\n* Atrial fibrillation, flutter, or arrhythmias during CT acquisition.\n* Previous PCI in the target vessel or CABG.\n* BMI ≥ 40 kg/m2\n* Insufficient CT quality assessed by the Core lab.\n* Comorbidity with life expectancy ≤ 2 years.\n* Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.\n* The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.\n* The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.\n* The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.\n* Subject has a platelet count \\<100,000 cells/mm3 or \\>700,000 cells/mm3.\n* The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.\n* The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy \\<2 years for any non-cardiac cause.\n* Subject is currently participating in another investigational drug or device clinical study.\n* Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.\n* Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n* Unable to provide written informed consent (IC).","locations":[{"facility":"Bringham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis Heart Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HACKENSACK MERIDIAN HEALTH, Inc","city":"Jersey City","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NewYork-Presbyterian/Weill Cornell Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Medical College of Cornell University","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azorg Hospital, Aalst","city":"Aalst","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Leon","city":"León","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Leicester NHS Trust","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guys & St Thomas Nhs Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital (Barts Health NHS Trust)","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St George's University Hospitals NHS Foundations Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Newcastle Hospitals NHS Foundations Trust","city":"Newcastle","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"John Radcliffe Hospital, Oxford","city":"Oxford","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"CAROLINA FOCELLA","phone":"001 917 753 6695","email":"cfocella@crf.org"},{"name":"CARLOS COLLET, MD,PhD","phone":"001 917 753 6695","email":"carloscollet@gmail.com"}],"primaryOutcomes":["Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)","Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts","minneapolis-minnesota","jersey-city-new-jersey","new-york-new-york","aalst-belgium","barcelona-spain","le-n-spain","madrid-spain","leicester-united-kingdom","london-united-kingdom","newcastle-united-kingdom","oxford-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: CT(Computed Tomography) guided Percutaneous Coronary Intervention for Cardiovascular Diseases","inPlainEnglish":"The OPTIMAL randomly assigned clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.","whoItsFor":["Ages 18 Years to 85 Years","The subject must be at least 18 years of age and younger than 85 years old","All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm"],"whoShouldSkip":["STEMI as the clinical presentation","Uncontrolled or recurrent ventricular tachycardia","Hemodynamic instability","Hemodialysis or peritoneal dialysis","Left main coronary artery stenosis \\> 50%","Atrial fibrillation, flutter, or arrhythmias during CT acquisition","Previous PCI in the target vessel or CABG"],"whatHappens":"If you join, the listed intervention(s) are CT(Computed Tomography) guided Percutaneous Coronary Intervention, or IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention. The registry lists allocation as randomized. The OPTIMAL randomly assigned clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 700 people at 15 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.442Z"},{"nctId":"NCT07287150","title":"A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer","officialTitle":"A Phase II, Randomized, Multicenter, Open-Label Study Evaluating the Efficacy and Safety of the Combination of Inavolisib Plus Enzalutamide Versus Physician's Choice of ARPI or Docetaxel in Patients With Metastatic Castration-Resistant Prostate Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study will evaluate the efficacy and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.","conditions":["Metastatic Castration-Resistant Prostate Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Inavolisib"},{"type":"DRUG","name":"Enzalutamide"},{"type":"DRUG","name":"Abiraterone"},{"type":"DRUG","name":"Docetaxel"}],"enrollment":100,"startDate":"2026-03-11","completionDate":"2028-03-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features\n* Progressive metastatic CRPC, defined as any of the following: PSA progression, defined by a minimum of two rising PSA values from three consecutive assessments with an interval of at least 7 days between assessments and with a minimal starting value of PSA \\>=1 ng/mL; The most recent qualifying PSA value must be determined within 14 days of enrollment; Soft tissue disease progression, defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); Bone disease progression, defined by PCWG3 criteria, with two or more new metastatic bone lesions on a whole-body radionuclide bone scan\n* Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for at least 12 weeks for HSPC or CRPC\n* Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Fasting glucose \\<126 mg/dL and HbA1c \\< 6%\n\nExclusion Criteria:\n\n* Presence of liver metastasis\n* Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway\n* Type 1 or Type 2 diabetes mellitus\n* Prior treatment for mCRPC with cytotoxic chemotherapy or novel hormonal treatments (e.g., androgen receptor degraders, CYP11 inhibitors), with the following treatments permitted: Prior docetaxel in mHSPC, providing no evidence of disease progression occurred during treatment or within 6 months of treatment completion; Prior docetaxel in the adjuvant or neoadjuvant setting providing no evidence of disease progression occurred during treatment or within 12 months of treatment completion; Prior treatment with sipuleucel-T, with the last dose administered \\>28 days prior to start of treatment; Prior PARPi therapy, as per local prescribing information, with the last dose administered \\>14 days prior to start of treatment; One prior RLT or radiotherapeutic agent (e.g., PSMA-targeted RLT, Radium 223) with the last dose administered \\>8 weeks prior to start of treatment\n* Other concurrent anti-cancer therapy except for androgen deprivation therapy\n* Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment\n* Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment","locations":[{"facility":"VA West Los Angeles Medical Center - (CRS) - NAVREF - PPDS","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSF","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Holden Comprehensive Cancer Center","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Einstein Cancer Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lifespan Cancer Institute","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grand Strand Regional Medical Center","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal North Shore Hospital-Pacific Hwy","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunshine Coast University Hospital","city":"Birtinya","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Brisbane & Women's Hospital","city":"Herston","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Box Hill Hospital","city":"Box Hill","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade Da Santa Casa de Misericordia de Porto Alegre","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia","city":"Santo André","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Cancer - INCa","city":"Rio de Janeiro","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de recherche du Centre Hospitalier de l'Universite de Montreal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jewish General Hospital","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"EDOG - Institut Bergonie - PPDS","city":"Bordeaux","state":"Gironde","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Léon Bérard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Paoli Calmettes","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Freiburg","city":"Freiburg im Breisgau","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Münster","city":"Münster","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Studienpraxis Urologie","city":"Nürtingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituti Fisioterapici Ospitalieri","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele S.r.l. - PPDS","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori","city":"Milan","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Oncologico Veneto - Sede di Castelfranco Veneto c/o Ospedale San Giacomo Apostolo","city":"Castelfranco Veneto","state":"Veneto","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital MAC León","city":"León","state":"Guanajuato","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Productos y Servicios Oncologicos Acacias SA de CV","city":"Benito Juárez","state":"Mexico CITY (federal District)","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Pharma Professional Research S.A de C.V.","city":"Mexico City","state":"Mexico CITY (federal District)","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggido","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center.","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Cruces","city":"Barakaldo","state":"Vizcaya","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"C.H. Regional Reina Sofia - PPDS","city":"Córdoba","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Instituto Valenciano de Oncologia (IVO)","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"VM Medical Park Samsun Hastanesi","city":"Atakum","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koc Universitesi Hastanesi","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Izmir Medical Point Hospital","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Park Seyhan Hospital","city":"Seyhan","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden in Sutton, Surrey - Downs Rd","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre","city":"Cardiff","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CO45813 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Radiographic Progression-free Survival (rPFS)"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","aurora-colorado","iowa-city-iowa","the-bronx-new-york","providence-rhode-island","myrtle-beach-south-carolina","st-leonards-australia","birtinya-australia","herston-australia","box-hill-australia","porto-alegre-brazil","santo-andr-brazil","s-o-jos-do-rio-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","toronto-canada","montreal-canada","bordeaux-france","villejuif-france","lyon-france","marseille-france","freiburg-im-breisgau-germany","hamburg-germany","m-nster-germany","n-rtingen-germany","rome-italy","milan-italy","castelfranco-veneto-italy","le-n-mexico","benito-ju-rez-mexico","mexico-city-mexico","seongnam-si-south-korea","seoul-south-korea","barakaldo-spain","c-rdoba-spain","madrid-spain","valencia-spain","ankara-turkey-t-rkiye","atakum-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","seyhan-turkey-t-rkiye","sutton-united-kingdom","cardiff-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Inavolisib for Metastatic Castration-Resistant Prostate Cancer","inPlainEnglish":"This study will measure the how well it works and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.","whoItsFor":["Ages 18 Years to any","Men only","Histologically or cytologically confirmed adenocarcinoma of the prostate without small-cell or neuroendocrine features","Treatment with at least one, but no more than one, prior second-generation ARPi (abiraterone, apalutamide, enzalutamide, darolutamide) for at least 12 weeks for HSPC or CRPC","Availability of a tumor tissue specimen that is suitable (e.g., adequate quality and quantity) for use in determining biomarker status","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1","Fasting glucose \\<126 mg/dL and HbA1c \\< 6%"],"whoShouldSkip":["Presence of liver metastasis","Prior treatment with any phosphatidylinositol-3-kinase (PI3K), protein kinase B (AKT), or mammalian target of rapamycin (mTOR) inhibitor, or with any agent with a mechanism of action of inhibiting the PI3K/AKT/mTOR pathway","Type 1 or Type 2 diabetes mellitus","Other concurrent anti-cancer therapy except for androgen deprivation therapy","Treatment with strong CYP2C8 inhibitors, strong or moderate CYP2C8 inducers, or strong CYP3A4 inducers within 1 week or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study treatment","Transfusion of any blood product for the sole purpose of making a potential participant eligible for study inclusion or within 28 days of enrollment"],"whatHappens":"If you join, the listed intervention(s) are Inavolisib, Enzalutamide, or Abiraterone. The registry lists allocation as randomized. This study will measure the how well it works and safety of the combination of inavolisib plus enzalutamide compared with physician's choice of alternative androgen receptor pathway inhibitor (ARPi) or docetaxel in biomarker-selected participants with metastatic castrate-resistant prostate cancer (mCRPC) who have received one prior second-generation ARPi.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at 50 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.315Z"},{"nctId":"NCT07287397","title":"Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS","officialTitle":"Phase 1/2 Investigation of Novel Experimental Regimen in Amyotrophic Lateral Sclerosis (Pioneer-ALS): An Open-Label, Uncontrolled, Multicenter Study to Assess the Safety and Tolerability of Two Doses of VTx-002","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Vector Y Therapeutics","sponsorClass":"INDUSTRY","summary":"PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will evaluate the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).\n\nTwo escalating dose (low dose and high dose) cohorts are planned. The duration of the study will be a maximum of 5 years and 5 weeks (265 weeks) for each participant. The screening period may last up to 5 weeks to complete screening procedures.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["ALS"],"interventions":[{"type":"GENETIC","name":"VTx-002"},{"type":"DRUG","name":"Preventative (Prophylactic) Medication - Corticosteroids: Methylprednisolone"}],"enrollment":36,"startDate":"2025-12-19","completionDate":"2027-10-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Capable of, and willing to, provide written informed consent and comply with study procedures, including visits to the study site and visit requirements\n2. Male or female ≥ 18 years of age\n3. Has a diagnosis of ALS according to the El Escorial criteria (Brooks, et al., 2000) (probable, laboratory results supported; clinically probable, clinically definite)\n4. Confirmed absence of ALS caused by FUS and SOD1 gene mutations confirmed by laboratory tests.\n5. A maximum of 18 months since first appearance of weakness (e.g., limb weakness, dysarthria, dysphagia, shortness of breath)\n6. Erect (seated) SVC % predicted ≥ 80% at Screening\n7. Treatment Research Initiative to Cure ALS (TRICALS) risk score between -2 and -6 at Screening\n8. Has a reliable caregiver/partner/legal representative willing and able to support the participant in participation in the study and to give informed consent on behalf of the participant in the case that disease progression prevents the participant of giving consent (local legal rules will apply).\n9. Treatment with riluzole and/or edaravone is allowed if treatment was started and has remained at a stable dose for at least 2 weeks (riluzole) or one treatment cycle (edaravone) before the Screening visit\n10. Women of childbearing potential (WOCBP) and male participants with female partners who are WOCBP must agree to use highly effective contraception during and after the study. WOCBP cannot be pregnant or breastfeeding\n11. Women of nonchildbearing potential must be post-menopausal or surgically sterile (e.g. hysterectomy, bilateral tubal ligation, ovaries removed)\n\nKey Exclusion Criteria:\n\n1. Diagnosis of a significant CNS or peripheral nervous system disease other than ALS that may be a cause for the participant's ALS symptoms or may confound study objectives\n2. Spinal, cervical, or brain MRI/MRA indicating clinically significant abnormality\n3. Presence of tracheostomy and feeding tube at Screening\n4. Contraindications to corticosteroid use (e.g. due to osteoporosis, uncontrolled blood pressure, diabetes or cholesterol).\n\n5\\. Significant concomitant disease or condition within 6 months of Screening that could pose an unacceptable safety risk to the participant or interfere with the participant's ability to comply with study procedures, e.g. heart disease, uncontrolled diabetes, liver disease, autoimmune diseases needing strong immune-suppressing drugs, cancer, etc or a current psychiatric diagnosis.\n\n6\\. Clinically significant abnormalities in laboratory test results at Screening for example poor liver or kidney function, abnormal clotting or infections such as Hepatitis or HIV\n\n7\\. Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) and being unable to safely stop them before certain study procedures.\n\n8\\. Contraindications to imaging methods MRI, MRA, CT due to claustrophobia and/or intolerance to contrast agents.\n\n9\\. Contraindications to general anaesthesia (GA) or deep sedation\n\n10 Positive test for illegal drugs (except prescribed medications or permitted medicinal/recreational marijuana if used responsibly)\n\n11\\. Generally frail or if the Investigator deems participation in the study would not be in the best interest of the participant or is likely to prohibit further participation during the study\n\nOther protocol-defined inclusion/exclusion criteria may apply\n\n\\-","locations":[{"facility":"St Joseph's Hospital and medical Center - Barrow Neurological Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego Medical Center","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Eleanor & Lou Gehrig ALS Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMC Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Hallamshire Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr Olga Uspenskaya Chief medical Officer, VectorY Therapeutics, M.D; PhD","phone":"patients@vectorytx.com","email":"patients@vectorytx.com"}],"primaryOutcomes":["The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)","The number of participants with treatment related adverse events (AEs) and Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","san-diego-california","jacksonville-florida","boston-massachusetts","new-york-new-york","philadelphia-pennsylvania","leuven-belgium","utrecht-netherlands","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Preventative (Prophylactic) Medication - Corticosteroids: Methylprednisolone for Amyotrophic Lateral Sclerosis","inPlainEnglish":"PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will measure the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS). Two escalating dose (low dose and high dose) cohorts are planned.","whoItsFor":["Ages 18 Years to any","Male or female ≥ 18 years of age","Has a diagnosis of ALS according to the El Escorial criteria (Brooks, et al., 2000) (probable, laboratory results supported; clinically probable, clinically definite)","Confirmed absence of ALS caused by FUS and SOD1 gene mutations confirmed by laboratory tests","A maximum of 18 months since first appearance of weakness (e.g., limb weakness, dysarthria, dysphagia, shortness of breath)","Erect (seated) SVC % predicted ≥ 80% at Screening","Treatment Research Initiative to Cure ALS (TRICALS) risk score between -2 and -6 at Screening","Treatment with riluzole and/or edaravone is allowed if treatment was started and has remained at a stable dose for at least 2 weeks (riluzole) or one treatment cycle (edaravone) before the Screening visit"],"whoShouldSkip":["Diagnosis of a significant CNS or peripheral nervous system disease other than ALS that may be a cause for the participant's ALS symptoms or may confound study objectives","Spinal, cervical, or brain MRI/MRA indicating clinically significant abnormality","Presence of tracheostomy and feeding tube at Screening","Contraindications to corticosteroid use (e.g. due to osteoporosis, uncontrolled blood pressure, diabetes or cholesterol)","6\\. Clinically significant abnormalities in laboratory test results at Screening for example poor liver or kidney function, abnormal clotting or infections such as Hepatitis or HIV","7\\. Use of blood thinners (e.g., warfarin, heparin, and novel oral anticoagulants) and being unable to safely stop them before certain study procedures","8\\. Contraindications to imaging methods MRI, MRA, CT due to claustrophobia and/or intolerance to contrast agents"],"whatHappens":"If you join, the listed intervention(s) are VTx-002, or Preventative (Prophylactic) Medication - Corticosteroids: Methylprednisolone. The registry lists allocation as randomized. PIONEER-ALS is a Phase 1/2, multicenter, open-label, ascending dose, uncontrolled, first-in-human study that will measure the safety, tolerability and effects on clinical and biomarker endpoints of intracisternal administration of Vtx-002 in participants with Amyotrophic Lateral Sclerosis (ALS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 36 people at 9 sites. Taking part typically means taking a study drug (or dummy pill), genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.601Z"},{"nctId":"NCT07288138","title":"A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)","officialTitle":"A Phase 2a, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of a THRβ Agonist (ECC4703), an SSAO Inhibitor (ECC0509), and Their Combination in Adults With Presumed MASH","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eccogene","sponsorClass":"INDUSTRY","summary":"The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.","conditions":["Metabolic Dysfunction-associated Steatohepatitis"],"keywords":["Liver Disease","Nonalcoholic Steatohepatitis","ECC0509","ECC4703"],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"ECC4703"},{"type":"DRUG","name":"ECC0509"},{"type":"DRUG","name":"ECC4703"}],"enrollment":160,"startDate":"2025-12-15","completionDate":"2027-09-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults between 18 and 75 years of age, inclusive, who can provide written informed consent and comply with study procedures.\n2. Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP \\>280 dB/m at screening with presence of metabolic risk factors.\n3. Evidence of hepatic steatosis confirmed by FibroScan® LSM \\> 7 kPa and \\< 20 kPa and MRI-PDFF \\>8% at screening.\n4. BMI \\>25 kg/m\\^2 to \\<50 kg/m\\^2 (non-Asian); BMI ≥23.0 to \\<50.0 kg/m\\^2 (Asian).\n5. ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period.\n6. Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\\^2 (Chronic Kidney Disease Epidemiology Collaboration, \\[CKD-EPI\\]).\n7. Stable body weight (no \\>5% change) for at least 6 months prior to screening.\n8. Willing to comply with contraception requirements (as applicable to males and females of childbearing potential).\n9. In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments.\n\nExclusion Criteria:\n\n1. Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury.\n2. Presence of cirrhosis on liver histology according to the assessment of the central reader, and/or cross-sectional imaging evidence consistent with cirrhosis and/or portal hypertension (e.g, nodular liver contour; portosystemic collaterals, ascites, splenomegaly; known presence or history of esophageal varices; and/or elastography evidence consistent with cirrhosis).\n3. ALT and/or AST \\>5× Upper Limit of Normal (ULN) or ALP \\>2×ULN at screening.\n4. Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders.\n5. Type 1 diabetes, HbA1c \\>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days.\n6. Use of medications that affect liver fat or fibrosis (e.g., Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) not on a stable dose, pioglitazone, obeticholic acid, high-dose vitamin E, hepatotoxic drugs) within protocol-specified washout periods.\n7. Significant alcohol use within 1 year prior to screening.\n8. Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \\[NYHA III-IV\\]), or uncontrolled arrhythmia.\n9. Current or recent serious psychiatric illness, including psychosis, active suicidal ideation, or suicide attempt within 5 years.\n10. Pregnancy, breastfeeding, or conditions that increase risk or interfere with study procedures, including MRI contraindications or other investigator-determined safety concerns.","locations":[{"facility":"Arizona Liver Health","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health - Peoria","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adobe Clinical Research, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Liver Health - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Gastroenterology, P.A","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARcare Center for Clinical Research","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research","city":"Apple Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARK Clinical Research - Fountain Valley","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSD Medical Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knowledge Research Center","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research","city":"Victorville","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Awareness, Inc.","city":"Jupiter","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evolution Clinical Trials","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Floridian Clinical Research, LLC","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ocala GI Research","city":"Ocala","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Progressive Medical Research","city":"Port Orange","state":"Florida","country":"United 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Research Institute (STRI)","city":"Edinburg","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dallas Research Institute, LLC","city":"Farmers Branch","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care United Research","city":"Forney","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evidentis Clinical Research","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance Digestive Health Associates of Texas - Garland","city":"Garland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pinnacle Clinical Research - Georgetown","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Research Institute - Medical 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MRI-PDFF, Comparing ECC4703 Monotherapy Versus Placebo"],"hasResults":false,"conditionSlugs":["fatty-liver"],"drugSlugs":[],"locationSlugs":["chandler-arizona","peoria-arizona","tucson-arizona","little-rock-arkansas","apple-valley-california","fountain-valley-california","la-jolla-california","lancaster-california","long-beach-california","orange-california","victorville-california","bradenton-florida","jupiter-florida","miami-florida","miami-lakes-florida","ocala-florida","port-orange-florida","viera-florida","west-palm-beach-florida","decatur-georgia","marietta-georgia","glenview-illinois","gurnee-illinois","south-bend-indiana","covington-louisiana","houma-louisiana","marrero-louisiana","metairie-louisiana","monroe-louisiana","shreveport-louisiana","west-monroe-louisiana","greenbelt-maryland","columbia-missouri","st-louis-missouri","las-vegas-nevada","marlton-new-jersey","sparta-new-jersey","fayetteville-north-carolina","akron-ohio","dayton-ohio","springboro-ohio","westlake-ohio","columbia-south-carolina","cordova-tennessee","austin-texas","bellaire-texas","brownsville-texas","corpus-christi-texas","edinburg-texas","farmers-branch-texas","forney-texas","fort-worth-texas","garland-texas","georgetown-texas","houston-texas","pasadena-texas","san-antonio-texas","sugar-land-texas","waco-texas","webster-texas","wichita-falls-texas","richmond-virginia"],"enrichment":{"headline":"Phase 2: testing Placebo for Metabolic Dysfunction-associated Steatohepatitis","inPlainEnglish":"The primary objective of this trial is to measure the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of presumed MASH based on: liver biopsy within 180 days prior to screening showing an NAFLD activity score (NAS) of ≥3 and a fibrosis score (F) of F1-3 OR FibroScan® CAP \\>280 dB/m at screening with presence of metabolic risk factors","Evidence of hepatic steatosis confirmed by FibroScan® LSM \\> 7 kPa and \\< 20 kPa and MRI-PDFF \\>8% at screening","body-mass index (BMI) \\>25 kg/m\\^2 to \\<50 kg/m\\^2 (non-Asian); body-mass index (BMI) ≥23.0 to \\<50.0 kg/m\\^2 (Asian)","ALT ≥60 U/L at the first screening visit and stability of ALT and AST levels during the screening period","Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m\\^2 (Chronic Kidney Disease Epidemiology Collaboration, \\[CKD-EPI\\])","Stable body weight (no \\>5% change) for at least 6 months prior to screening","In the opinion of the investigator, able to participate safely and complete required MRI/biomarker assessments"],"whoShouldSkip":["Chronic liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)/MASH, including alcoholic liver disease, autoimmune hepatitis, cholestatic disease, genetic liver diseases, or drug-induced liver injury","ALT and/or AST \\>5× Upper Limit of Normal (ULN) or ALP \\>2×ULN at screening","Clinically significant thyroid or adrenal dysfunction, including uncontrolled hypothyroidism, hyperthyroidism, or adrenal disorders","Type 1 diabetes, HbA1c \\>9.5%, or unstable type 2 diabetes requiring medication changes within 90 days","Use of medications that affect liver fat or fibrosis (e.g., Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) not on a stable dose, pioglitazone, obeticholic acid, high-dose vitamin E, hepatotoxic drugs) within protocol-specified washout periods","Significant alcohol use within 1 year prior to screening","Recent cardiovascular events, including myocardial infraction (MI), stroke, unstable angina, heart failure (New York heart association \\[NYHA III-IV\\]), or uncontrolled arrhythmia"],"whatHappens":"If you join, the listed intervention(s) are Placebo, ECC4703, or ECC0509. The registry lists allocation as randomized. The primary objective of this trial is to measure the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 69 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.144Z"},{"nctId":"NCT07288411","title":"Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.","officialTitle":"Pilot Study of the Effects of Transcutaneous Non-Invasive Vagus Nerve Stimulation (nVNS) on Symptoms and Brain Mechanisms in Premenopausal Women With Temporomandibular Disorders (TMD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Arpana Church","sponsorClass":"OTHER","summary":"The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis.\n\nParticipants will be asked to come in for 2 in-clinic visits, at baseline and post treatment. Participants will also be asked to come in 2x/week for 8 consecutive weeks to receive the nVNS treatment. The in-clinic visits will include physical measures, blood draw, saliva sample, and brain MRI. Participants will be asked to collect a stool sample at home and answer online questionnaires regarding, mood, pain, and health behaviors at home, prior to the in-clinic appointments.","conditions":["TMD","Temporomandibular Disorders (TMDs)"],"keywords":["TMD","Temporomandibular Disorders","non-invasive vagus nerve stimulation","nVNS"],"interventions":[{"type":"DEVICE","name":"nVNS Treatment"}],"enrollment":10,"startDate":"2026-12","completionDate":"2027-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ages 18-50\n* Premenopausal menstruating women\\*\n* Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise.\n* Specific screening reveals clinical findings that include TMJ and/or masticatory and cervical muscle pain.\n* Must have a negative urine test for pregnancy\n* Ability to speak the English language fluently due to the standardized assessments involved\n* Right-handed (participants are limited to right-handed individuals to reduce variability in brain lateralization and ensure more consistent, interpretable data).\n\n  * Only premenopausal women are included to control for hormonal variability that may influence the results. Participants will be scheduled during their follicular phase based on self-reported last menstrual period to further reduce hormonal confounds.\n\nExclusion Criteria:\n\n* Medical condition, laboratory finding, or physical exam finding that precludes participation, such as systemic arthritides, juvenile idiopathic arthritis, idiopathic condylar resorption, connective tissue disorders, mandibular osteonecrosis, mandibular and condylar fractures, salivary gland disorders (incl. history of stones or swelling), neoplasms, neurologic/neuropathic, endocrine, or immune/autoimmune diseases and congenital or developmental disorders.\n* Pathologic processes found on imaging including neoplasm (Exception: disc displacements and osseous pathology including osteoarthritis/osteoarthrosis).\n* Radiation treatment to head and neck\n* Prior jaw or open TMJ (including contralateral joint) surgery including plication, chondroplasty, joint replacement, disectomy, and discoplasty.\n* Intra-articular therapies of TMJ being sampled that include arthrocentesis, visco-supplementation, and steroid, platelet-rich plasma/platelet-rich fibrin administration within the last 6mo\n* Recent febrile illness within the past 8 weeks that precludes or delays participation by more than 90 days\n* Trauma to jaw in the last 2mo\n* Presence of non-TMD orofacial pain disorders excluding comorbidity of interest (fibromyalgia).\n* Pregnancy or lactation\n* Undergoing or previously undergone bone anabolic or other hormonal therapies for medical needs\n* Unable to participate due to language barrier or mental/intellectual incompetence\n* Use of antidepressant drugs unless the participants have been on a stable dose for 60 days.\n* Drug and/or alcohol abuse in the past year\n* Ongoing dental treatments requiring invasive procedures (e.g. implant placement, tooth extractions, etc.)\n* Recent dental treatments within past two weeks that required sustained mouth opening for more than 20 minutes.\n* Wearing removable or implant supported dentures or fixed orthodontic appliances\n* Unable or unwilling to give informed consent\n* Participation in another clinical study that interferes with participation in this study\n* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study.\n* Presence of non-TMD orofacial pain disorders such as that from periodontal disease and carious lesions.\n* Presence of major psychiatric diagnosis such as schizophrenia, bipolar disorder, post-traumatic stress disorder, obsessive compulsive disorder, or current history of drug or alcohol abuse.\n* Individuals with current regular use of narcotics and/or opioids. Use of centrally acting medications that will interfere with neuroimaging testing, such as systemic steroids, opiate analgesics.\n* Smokes/Vapes tobacco more than 1/3 pack per day","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Allison Vaughan, MPH","phone":"3108257206","email":"ChurchLab@mednet.ucla.edu"}],"primaryOutcomes":["Pain Intensity","Pain Unpleasantness","Positive and Negative Affect"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: nVNS Treatment for TMD","inPlainEnglish":"The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD). Non-invasive vagus nerve stimulation (nVNS) is the most well researched and possibly the most effective non-invasive neuromodulation treatment for chronic pain conditions that targets the brain-gut-microbiome (BGM) axis.","whoItsFor":["Ages 18 Years to 50 Years","Women only","Premenopausal menstruating women\\*","Participants report or present with at least 1 of 3 cardinal signs of TMD: jaw pain, limited mouth opening, or TMJ noise","Specific screening reveals clinical findings that include TMJ and/or masticatory and cervical muscle pain","Must have a negative urine test for pregnancy","Ability to speak the English language fluently due to the standardized assessments involved","Right-handed (participants are limited to right-handed individuals to reduce variability in brain lateralization and ensure more consistent, interpretable data)","Only premenopausal women are included to control for hormonal variability that may influence the results. you would be scheduled during their follicular phase based on self-reported last menstrual period to further reduce hormonal confounds"],"whoShouldSkip":["Pathologic processes found on imaging including neoplasm (Exception: disc displacements and osseous pathology including osteoarthritis/osteoarthrosis)","Radiation treatment to head and neck","Prior jaw or open TMJ (including contralateral joint) surgery including plication, chondroplasty, joint replacement, disectomy, and discoplasty","Intra-articular therapies of TMJ being sampled that include arthrocentesis, visco-supplementation, and steroid, platelet-rich plasma/platelet-rich fibrin administration within the last 6mo","Recent febrile illness within the past 8 weeks that precludes or delays participation by more than 90 days","Trauma to jaw in the last 2mo","Presence of non-TMD orofacial pain disorders excluding comorbidity of interest (fibromyalgia)"],"whatHappens":"If you join, the listed intervention(s) are nVNS Treatment. The registry lists allocation as na. The study aims to examine the effects of transcutaneous non-invasive vagus nerve stimulation (nVNS) on symptoms and brain mechanisms in premenopausal women with temporomandibular disorders (TMD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Los Angeles. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.446Z"},{"nctId":"NCT07290036","title":"A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults","officialTitle":"An Open-label, Randomized, Parallel-group, Noninferiority Study to Evaluate the Pharmacokinetics of Bimekizumab Administered Intravenously or as a Subcutaneous Injection in Participants With Active Psoriatic Arthritis and/or Active Axial Spondyloarthritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"UCB Biopharma SRL","sponsorClass":"INDUSTRY","summary":"To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.","conditions":["Psoriatic Arthritis","Axial Spondyloarthritis"],"keywords":["Bimekizumab, BKZ, Phase 1B"],"interventions":[{"type":"DRUG","name":"Bimekizumab regimen 1 iv"},{"type":"DRUG","name":"Bimekizumab regimen 2 iv"},{"type":"DRUG","name":"Bimekizumab regimen 3 sc"}],"enrollment":392,"startDate":"2025-12-10","completionDate":"2028-05-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Be 18+ years old and legally able to consent\n2. Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment\n3. Weigh between 45-100 kg (females) or 50-100 kg (males).\n4. Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago\n\nExclusion Criteria:\n\n1. Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)\n2. Severe psychiatric issues or substance abuse in the past year\n3. Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)\n4. Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))\n5. Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)\n6. Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)","locations":[{"facility":"Pa0019 114","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 127","city":"Apple Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 111","city":"Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 119","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 117","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 125","city":"San Leandro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 126","city":"Temecula","state":"California","country":"United 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417","city":"Olsztyn","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 406","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 408","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 411","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 415","city":"Płońsk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 416","city":"Torun","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 405","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 409","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 414","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 420","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 601","city":"Košice","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 602","city":"Košice","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pa0019 603","city":"Piešťany","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"UCB Cares","phone":"+18445992273","email":"ucbcares@ucb.com"},{"name":"UCB Cares","phone":"+18445992273","email":""}],"primaryOutcomes":["Steady-state Trough Concentration (Ctrough,ss) at Week 16"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["peoria-arizona","apple-valley-california","covina-california","fullerton-california","riverside-california","san-leandro-california","temecula-california","upland-california","whittier-california","fort-collins-colorado","ormond-beach-florida","south-miami-florida","zephyrhills-florida","chicago-illinois","lansing-michigan","west-long-branch-new-jersey","albuquerque-new-mexico","vandalia-ohio","duncansville-pennsylvania","rock-hill-south-carolina","jackson-tennessee","murfreesboro-tennessee","baytown-texas","colleyville-texas","mesquite-texas","plano-texas","bellevue-washington","spokane-washington","beckley-west-virginia","lovech-bulgaria","pleven-bulgaria","plovdiv-bulgaria","brno-czechia","hlu-n-czechia","ostrava-czechia","uhersk-hradi-t-czechia","berlin-germany","hamburg-germany","ratingen-germany","wetzlar-germany","bialystok-poland","bydgoszcz-poland","bytom-poland","elblag-poland","krakow-poland","lodz-poland","lublin-poland","nowa-s-l-poland","olsztyn-poland","poznan-poland","p-o-sk-poland","torun-poland","warsaw-poland","wroclaw-poland","ko-ice-slovakia","pie-any-slovakia"],"enrichment":{"headline":"Phase 1: testing Bimekizumab regimen 1 iv for Psoriatic Arthritis","inPlainEnglish":"To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.","whoItsFor":["Ages 18 Years to any","Be 18+ years old and legally able to consent","Have active psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA), suitable for bimekizumab treatment","Weigh between 45-100 kg (females) or 50-100 kg (males)","Be biologic disease-modifying anti-rheumatic drug (bDMARD)-naïve or have stopped bDMARDs ≥3 months or 5 half-lives ago"],"whoShouldSkip":["Serious organ system disorders (e.g., heart, liver, kidney, gastrointestinal, neuro)","Severe psychiatric issues or substance abuse in the past year","Recent or chronic infections, including tuberculosis (TB) or nontuberculous mycobacterium (NTMB)","Other inflammatory diseases (e.g., rheumatoid arthritis (RA), lupus, inflammatory bowel disease (IBD))","Recent live vaccines (within 8 weeks) or Bacillus Calmette-Guerin (BCG) (within 1 year)","Recent use of glucagon-like peptide-1 (GLP-1) agonists (within 28 weeks)"],"whatHappens":"If you join, the listed intervention(s) are Bimekizumab regimen 1 iv, Bimekizumab regimen 2 iv, or Bimekizumab regimen 3 sc. The registry lists allocation as randomized. To demonstrate that bimekizumab administered intravenously is noninferior to subcutaneous administration.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 392 people at 65 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.573Z"},{"nctId":"NCT07290062","title":"A Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection (IT) of INS1202 in Participants With Amyotrophic Lateral Sclerosis (ALS)","officialTitle":"A Phase 1, Multicenter, Open-label, Dose-Finding Study to Investigate the Safety and Pharmacodynamics of a Single Intrathecal Injection of INS1202 in Patients With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Insmed Gene Therapy LLC","sponsorClass":"INDUSTRY","summary":"The primary objective of this dose-finding study is to evaluate the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"GENETIC","name":"INS1202"}],"enrollment":23,"startDate":"2026-01-09","completionDate":"2030-03-31","sex":"ALL","minAge":"18 Years","maxAge":"79 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria: -\n\n* Participant with body mass index (BMI) ≥18 kilograms per square meter (kg/m\\^2).\n* Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria.\n* Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS.\n* SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS.\n* Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention.\n* Baseline ALSFRS-R ≥ 24.\n* ALS disease duration ≤ 42 months.\n\nKey Exclusion Criteria: -\n\n* Previous treatment for ALS with cellular or gene therapies.\n* Any investigational medication or treatment (for ALS or other condition).\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"USA005","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA004","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA002","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA003","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA009","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA001","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA007","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA006","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USA010","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Insmed Medical Information","phone":"1-844-446-7633","email":"medicalinformation@insmed.com"}],"primaryOutcomes":["Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","la-jolla-california","palo-alto-california","baltimore-maryland","worcester-massachusetts","columbia-missouri","columbus-ohio","philadelphia-pennsylvania","houston-texas"],"enrichment":{"headline":"Phase 1: INS1202 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"The primary objective of this dose-finding study is to measure the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.","whoItsFor":["Ages 18 Years to 79 Years","Participant with body mass index (body-mass index (BMI)) ≥18 kilograms per square meter (kg/m\\^2)","Participant with symptomatic ALS as diagnosed by Gold Coast diagnostic criteria","Sporadic ALS cohorts: Negative testing for known monogenic mutations associated with familial ALS","SOD1-ALS (Cohorts 2 and 3 only): Confirmed pathogenic SOD1 mutation, with negative testing for other genetic mutations associated with familial ALS","Any polymorphism or mutation in the coding region will require additional review by the Sponsor to determine compatibility with the study intervention","Baseline ALSFRS-R ≥ 24","ALS disease duration ≤ 42 months"],"whoShouldSkip":["Previous treatment for ALS with cellular or gene therapies","Any investigational medication or treatment (for ALS or other condition)","Note: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are INS1202. The registry lists allocation as randomized. The primary objective of this dose-finding study is to measure the safety, tolerability and pharmacodynamics of single dose of INS1202 via IT administration in participants ≥ 18 to \\<80 years of age with ALS who carry superoxide dismutase type 1 (SOD1) mutations or harbor no known ALS-related genetic mutation.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 23 people at 9 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.597Z"},{"nctId":"NCT07290803","title":"This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis Who Initiate or Switch Any Systemic Treatment","officialTitle":"Atopic Dermatitis Disease Registry of Adult and Adolescent Patients Initiating or Switching Systemic Treatments","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.\n\nThe study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[],"enrollment":1000,"startDate":"2025-11-17","completionDate":"2034-01-30","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged more than or equal to (≥) 12 years at the time of consent.\n* Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20.\n* Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)\n* Signed informed consent for registry participation by the patient or parent/legal representative and assent by the patient appropriate to the patient's age, including willingness to participate in long-term follow-up.\n\nExclusion Criteria:\n\n* Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care.\n* Insufficient understanding of the study by the patient and/or parent/guardian.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Cahaba Dermatology & Skin Health Center- Site Number : 8400006","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"River Region Dermatology and Laser- Site Number : 8400041","city":"Montgomery","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Tan Allergy & Asthma- Site Number : 8400031","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saguaro Dermatology- Site Number : 8400028","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kern Research, Inc.- Site Number : 8400047","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Dermatology Clinical Research- Site Number : 8400014","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Research Associates - Los Angeles- Site Number : 8400020","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northridge Clinical Trials, LLC- Site Number : 8400009","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research, LLC.- Site Number : 8400010","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empire Clinical Research, LLC- Site Number : 8400007","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Trials- Site Number : 8400019","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western States Clinical Research, Inc.- Site Number : 8400051","city":"Wheat Ridge","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Jude Clinical Research- Site Number : 8400049","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ziaderm Research, LLC- Site Number : 8400021","city":"North Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Skin Care Physicians of Georgia - Macon- Site Number : 8400034","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sneeze, Wheeze, & Itch Associates, LLC- Site Number : 8400029","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rosalind Franklin University of Medicine and Science- Site Number: 8400056","city":"North Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David Fivenson, MD, Dermatology, PLLC- Site Number : 8400017","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oakland Hills Dermatology- Site Number : 8400042","city":"Auburn Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Research Group - Bay City- Site Number : 8400052","city":"Bay City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Derm Institute of West Michigan- Site Number : 8400025","city":"Caledonia","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wayne State University - Detroit Medical Center- Site Number : 8400035","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Dermatology Institute - Waterford- Site Number : 8400013","city":"Waterford","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red River Research Partners, Llc- Site Number : 8400054","city":"Bolivar","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleaver Dermatology- Site Number : 8400033","city":"Kirksville","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy Asthma & Immunology- Site Number : 8400044","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Las Vegas Dermatology- Site Number : 8400002","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optima Research Portsmouth- Site Number : 8400032","city":"Portsmouth","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of New Mexico School Of Medicine- Site Number : 8400022","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Plastic Surgery and Dermatology- Site Number : 8400038","city":"Huntersville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest University Health Sciences- Site Number : 8400003","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red River Research Partners - Fargo- Site Number : 8400037","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Associates of Mid-Ohio- Site Number : 8400026","city":"Marion","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatologists of Southwest Ohio - Mason- Site Number : 8400050","city":"Mason","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC - Department of Dermatology- Site Number : 8400024","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access Research - Warwick 2- Site Number : 8400045","city":"Warwick","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Dermatology and Cosmetic Surgery - Spartanburg- Site Number : 8400004","city":"Spartanburg","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Reveal Research Institute - Dallas- Site Number : 8400012","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovate Research - Fort Worth- Site Number : 8400016","city":"Fort Worth","state":"Texas","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Austin Institute for Clinical Research, Inc- Site Number : 8400030","city":"Pflugerville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complete Dermatology - Sugar Land- Site Number : 8400001","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cope Family Medicine - Ogden Clinic- Site Number : 8400053","city":"Bountiful","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springville Dermatology - Springville- Site Number : 8400055","city":"Springville","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fuchs Dermatology- Site Number : 8400027","city":"Falls Church","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Dermatology Partners CRO LLC- Site Number : 8400011","city":"Mill Creek","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington - Roosevelt Location- Site Number : 8400005","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Origins Dermatology Centre-Site Number : 1240003","city":"Regina","state":"Saskatchewan","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital-Site Number: 1560008","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Eighth Affiliated Hospital, Sun Yat-sen University-Site Number: 1560006","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital of Central South University-Site Number : 1560001","city":"Changsha","state":"Hu'nan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University-Site Number: 1560014","city":"Changsha","state":"Hu'nan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xi'an Jiaotong University (Xibei Hospital)-Site Number: 1560002","city":"Xi’an","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University- Site Number: 1560003","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hangzhou First People's Hospital-Site Number: 1560004","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhejiang University School of Medicine-Site Number: 1560007","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Ningbo University-Site Number : 1560009","city":"Ningbo","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University-Site Number : 1560011","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University-Site Number: 1560012","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Besançon - Hôpital Jean Minjoz-Site Number: 2500010","city":"Besançon","state":"Doubs","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Valence-Site Number: 2500005","city":"Valence","state":"Drome","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GHRMSA - Hospital Emile Muller-Site Number : 2500006","city":"Mulhouse","state":"Haut Rhin","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de La Reunion-Site Number: 2500007","city":"Saint-Pierre","state":"Reunion","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopitaux Drome Nord-Site Number : 2500002","city":"Romans-sur-Isère","state":"Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier William Morey-Site Number: 2500008","city":"Chalon-sur-Saône","state":"Saone Et Loire","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier du Mans-Site Number: 2500004","city":"Le Mans","state":"Sarthe","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria delle Marche-Site Number: 3800009","city":"Ancona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Maggiore di Novara-Site Number: 3800005","city":"Novara","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia-Site Number : 3800006","city":"Reggio Emilia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri-Site Number: 3800002","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Takeoka Dermatology Clinic- Site Number : 3920005","city":"Marugame-shi","state":"Kagawa-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Habikino Medical Center-Site Number : 3920001","city":"Habikino-shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"JA-Shizuoka Enshu Hospital-Site Number: 3920003","city":"Hamamatsu","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erfan and Bagedo Hospital-Site Number : 6820002","city":"Jeddah","state":"","country":"Saudi 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Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mediclinic Hospital, AUH-Site Number: 7840004","city":"Abu Dhabi","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr Joseph Polyclinic Amber Clinic-Site Number: 7840005","city":"Al Karama","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology and Aesthetic Center Rashid Hospital-Site Number : 7840003","city":"Dubai","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Number of Participants Utilizing Atopic Dermatitis (AD) Treatment","Duration of Treatment","AD Treatment Sequences","Number of Participants Initiating AD Treatments with Reasons","Number of Participants Interrupting AD Treatment","Number of 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Baseline","Change in Sleep Disturbance as Measured with Sleep Disturbance Numeric Rating Scale (SD-NRS) from Baseline","Remission of AD"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","montgomery-alabama","gilbert-arizona","phoenix-arizona","bakersfield-california","fremont-california","los-angeles-california","northridge-california","oakland-california","pomona-california","san-diego-california","wheat-ridge-colorado","doral-florida","north-miami-beach-florida","macon-georgia","normal-illinois","north-chicago-illinois","ann-arbor-michigan","auburn-hills-michigan","bay-city-michigan","caledonia-michigan","detroit-michigan","waterford-michigan","bolivar-missouri","kirksville-missouri","lincoln-nebraska","las-vegas-nevada","portsmouth-new-hampshire","albuquerque-new-mexico","huntersville-north-carolina","winston-salem-north-carolina","fargo-north-dakota","marion-ohio","mason-ohio","pittsburgh-pennsylvania","warwick-rhode-island","spartanburg-south-carolina","dallas-texas","fort-worth-texas","pflugerville-texas","sugar-land-texas","bountiful-utah","springville-utah","falls-church-virginia","mill-creek-washington","seattle-washington","regina-canada","beijing-china","shenzhen-china","changsha-china","xian-china","chengdu-china","hangzhou-china","ningbo-china","chongqing-china","shanghai-china","besan-on-france","valence-france","mulhouse-france","saint-pierre-france","romans-sur-is-re-france","chalon-sur-sa-ne-france","le-mans-france","ancona-italy","novara-italy","reggio-emilia-italy","roma-italy","marugame-shi-japan","habikino-shi-japan","hamamatsu-japan","jeddah-saudi-arabia","riyadh-saudi-arabia","barcelona-spain","santa-cruz-de-tenerife-spain","alicante-spain","abu-dhabi-united-arab-emirates","al-karama-united-arab-emirates","dubai-united-arab-emirates"],"enrichment":{"headline":"This Study is a Non-interventional Disease Registry of Adolescent and Adult Patients With Atopic Dermatitis…","inPlainEnglish":"The objectives of this prospective non-treatment study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and measure the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions.","whoItsFor":["Ages 12 Years to any","Patients aged more than or equal to (≥) 12 years at the time of consent","Confirmed diagnosis of AD, of any severity, according to the Investigator's assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20","Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral Janus kinase (JAK) inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)"],"whoShouldSkip":["Concurrent participation in an treatment clinical trial that administers an investigational drug that modifies patient care","Insufficient understanding of the study by the patient and/or parent/guardian","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 82 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.828Z"},{"nctId":"NCT07291037","title":"Phase III Study of Datopotamab Deruxtecan Versus Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous NSCLC Without Actionable Genomic Alterations","officialTitle":"A Phase III, Randomised, Open-Label, Multicentre Study of Datopotamab Deruxtecan or Docetaxel in Previously Treated TROP2-positive Advanced or Metastatic Non-squamous Non-Small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung17)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"TROPION-Lung17 will measure the efficacy and safety of datopotamab deruxtecan (Dato-DXd) compared with docetaxel in patients with trophoblast cell surface protein 2 (TROP2) positive advanced or metastatic lung cancer without actionable genomic alterations (AGA).","conditions":["Non-small Cell Lung Cancer (NSCLC)"],"keywords":["TROPION-Lung17","Non-small cell lung cancer (NSCLC)","Advanced non-squamous NSCLC","Metastatic non-squamous NSCLC","Datopotamab deruxtecan (Dato-DXd; DS-1062a)","Docetaxel","Trophoblast cell surface protein 2 (TROP2)","Normalised membrane ratio (NMR)"],"interventions":[{"type":"DRUG","name":"Datopotamab deruxtecan (Dato-DXd)"},{"type":"DRUG","name":"Docetaxel"}],"enrollment":400,"startDate":"2025-10-31","completionDate":"2029-01-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Pathologically documented Stage IIIB, IIIC, or Stage IV non-squamous non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) at the time of randomisation and meets the criteria for NSCLC:\n\n* Participants must have documented negative test results for EGFR (eg, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation), ALK, and ROS1 genomic alterations.\n\nNote: If test results for EGFR, ALK, and ROS1 are not available, participants are required to undergo prospective testing performed centrally for these genomic alterations in a Sponsor-designated central laboratory.\n\n* Has no known tumour genomic alterations in NTRK, BRAF V600, RET, MET exon 14 skipping, KRAS G12C, or HER2. Additionally, participants must not have known tumour genomic alteration of any other actionable driver oncogenes for which there are locally approved targeted first-line therapies.\n\nNote: Participants whose tumours harbour BRAF (exception V600) or KRAS (exception G12C) mutations are eligible for the study.\n\n* Prospectively assessed TROP2 NMR positive based on results from an appropriately validated investigational TROP2 RxDx device in a Sponsor- designated, regulatory compliant central laboratory.\n\n  * Documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.\n  * Participants must have received platinum based chemotherapy (PBC) in combination with anti-programmed death-protein 1 (anti-PD-1)/anti-programmed death-ligand 1 (anti-PD-L1) monoclonal antibody (mAb) as the only prior line of therapy or received PBC and anti-PD-1/anti-PD-L1 monoclonal antibody (in either order) sequentially as the only 2 prior lines of therapy.\n  * Provision of acceptable formalin fixed and paraffin embedded (FFPE) tumour sample for assessment of TROP2.\n  * At least one lesion not previously irradiated that qualifies as a Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) target lesion (TL) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeated measurements.\n  * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.\n  * Adequate bone marrow reserve and organ function within 7 days before randomisation.\n\nExclusion Criteria:\n\n* Squamous, mixed NSCLC, or small cell lung cancer (SCLC) histology.\n* NSCLC disease that is eligible for definitive local therapy alone.\n* History of another primary malignancy other than NSCLC, except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence.\n* Spinal cord compression or brain metastases, unless asymptomatic, stable, and not requiring treatment with corticosteroids or anticonvulsants for at least 7 days prior to randomisation.\n* Clinically significant corneal disease.\n* Has active or uncontrolled hepatitis B or C virus infection.\n* Known human immunodeficiency virus (HIV) infection that is not well controlled.\n* Uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* History of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. 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Istituto Romagnolo per lo Studio dei Tumori (IRST) \"Dino Amadori\"","city":"Meldola","state":"Emilia-Romagna","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Pisana","city":"Pisa","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0089","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0016","city":"Pisa","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0017","city":"Osakasayama-shi","state":"Osaka","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0008","city":"Kashiwa","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0021","city":"Wroclaw","state":"Lower Silesian Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0105","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Uniwersyteckie Centrum Kliniczne","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"National University Hospital","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cha Bundang Medical Center, Cha University","city":"Seongnam-si","state":"Kyǒnggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0015","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Marañon","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0095","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Research UK - The Beatson Institute for Cancer Research (Cancer Research UK Beatson Laboratories)","city":"Glasgow","state":"South Western Scotland","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Clatterbridge Cancer Centre","city":"Metropolitan Borough of Wirral","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Number of participants with adverse events (AEs)","Number of participants with serious adverse events (SAEs) (as per Common Terminology Criteria for Adverse Events v5 (CTCAE v5))","Number of participants with AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria","Number of participants with AEs leading to discontinuation","Number of participants with AEs leading to death","Objective response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","los-angeles-california","chicago-illinois","detroit-michigan","hackensack-new-jersey","mineola-new-york","portland-oregon","nashville-tennessee","seattle-washington","camperdown-australia","westmead-australia","birtinya-australia","parkville-australia","santiago-chile","santiago-region-metropolitana-chile","hefei-china","beijing-china","chongqing-china","fuzhou-china","guangzhou-china","nanning-china","harbin-china","nanyang-china","nanjing-china","nanchang-china","xian-china","jinan-china","shanghai-china","chengdu-china","hangzhou-china","pessac-france","la-tronche-france","montpellier-france","saint-priest-en-jarez-france","bobigny-france","cologne-germany","l-beck-germany","frankfurt-germany","mainz-germany","meldola-italy","pisa-italy","milan-italy","osakasayama-shi-japan","kashiwa-japan","wroclaw-poland","warsaw-poland","gdansk-poland","singapore-singapore","seongnam-si-south-korea","seoul-south-korea","pamplona-spain","barcelona-spain","madrid-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan","london-united-kingdom","glasgow-united-kingdom","metropolitan-borough-of-wirral-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Pumitamig for Hepatocellular Carcinoma (HCC)","inPlainEnglish":"This study wants to measure the whether it is safe and how hard side effects are to live with of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)","whoItsFor":["Ages 18 Years to any","Participants must have a histologically confirmed diagnosis of locally advanced or unresectable Hepatocellular Carcinoma (HCC)","Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Participants must have no prior systemic therapy for advanced/ unresectable HCC","Participants must have measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1"],"whoShouldSkip":["Participants must not have significant bleeding or coagulation disorders or other obvious bleeding risk evidence","Participants must not have an organ transplant or autoimmune disease","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Pumitamig, or Ipilimumab. The registry lists allocation as randomized. This study wants to measure the whether it is safe and how hard side effects are to live with of Pumitamig alone or in combination with Ipilimumab in participants with first-line advanced or unresectable Hepatocellular Carcinoma (HCC)","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 198 people at 67 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.637Z"},{"nctId":"NCT07291453","title":"Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits","officialTitle":"Loving Habits: A Feasibility Study of a Support Program for Building New Parent-child Behavioral Habits","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Okinawa Institute of Science and Technology Graduate University","sponsorClass":"OTHER","summary":"This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content is focused on teaching parents strategies to better manage interactions with children in challenging situations many children experience, e.g., a transition to a non-preferred activity, waiting for delayed reward. Parents with children demonstrating inattentive, hyperactive and impulsive behavior and experiencing difficulties with these daily challenges are invited to participate in the study.","conditions":["ADHD"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Behavioral Parent Training"}],"enrollment":250,"startDate":"2025-10-04","completionDate":"2027-06","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Parents with children aged 4-10 who experience difficulties in situations targeted by the program.\n\n\\*Note: The program will be advertised that it was developed targeting children demonstrating behaviors consistent with ADHD, and the ADHD symptoms will be measured pre-post. However, children are not required to have a diagnosis of ADHD or show elevated levels of ADHD symptoms for the mothers to sign up.\n\nExclusion Criteria:\n\n\\- Parents who do not understand Japanese (the language the program is offered in).","locations":[{"facility":"Okinawa Institute of Science and Technology Graduate University","city":"Onna","state":"Okinawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emi Furukawa, PhD","phone":"+81989668814","email":"lovinghabits@oist.jp"}],"primaryOutcomes":["Number of videos viewed","Percentage of completed daily ratings","Participant satisfaction"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["onna-japan"],"enrichment":{"headline":"Not a traditional drug phase: Behavioral Parent Training for ADHD","inPlainEnglish":"This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, automatically delivered via a popular texting platform. The program content is focused on teaching parents strategies to better manage interactions with children in challenging situations many children experience, e.g., a transition to a non-preferred activity, waiting for delayed reward.","whoItsFor":["\\- Parents with children aged 4-10 who experience difficulties in situations targeted by the program"],"whoShouldSkip":["\\- Parents who do not understand Japanese (the language the program is offered in)"],"whatHappens":"If you join, the listed intervention(s) are Behavioral Parent Training. The registry lists allocation as randomized. This study evaluates the feasibility and preliminary impacts of a new parent support program consisting of a series of educational videos, automatically delivered via a popular texting platform.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 250 people at Onna. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.650Z"},{"nctId":"NCT07292012","title":"Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease","officialTitle":"Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","sponsorClass":"OTHER","summary":"Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease","conditions":["Crohn Disease (CD)"],"keywords":["crohn's disease","transmural healing","mirikizumab"],"interventions":[{"type":"DRUG","name":"Mirikizumab - IV"},{"type":"DRUG","name":"Mirikizumab - SC"}],"enrollment":75,"startDate":"2026-05-11","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with CD\n* ≥ 18 to ≤ 75 years-old\n* Symptomatic CD according to PRO-2 (stool \\> 3 or abdominal pain score \\> 1)\n* Transmural inflammation on baseline MRI (C-score \\> 0.5 in at least one segment)\n\nExclusion Criteria:\n\n* Prior exposure to anti-p19 biological therapy\n* Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase \\[JAK\\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents\n* Exclude any previous use of p19 IL23s agents\n* Contra-indication to mirikizumab\n* Definitive ostomy\n* Colectomy with IPAA\n* Isolated or uncontrolled perianal lesions\n* Severe obstructive symptoms\n* Intra-abdominal abscess\n* Contra-indication to MRI\n* No health insurance\n* Pregnant or lactating women\n* Patients already included in biomedical research other than an observational study (e.g., registry, cohort)\n* Concomitant Clostridioides difficile infection\n* HIV infection\n* Patient under guardianship, curatorship or safeguard of justice","locations":[{"facility":"CHU de Brest - Hôpital de la Cavale Blanche","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Caen Normandie","city":"Caen","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Clermont Ferrand - Hôpital d'Estaing","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nîmes Carémeau","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Mutualiste Monsouris","city":"Paris","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHU Poitiers","city":"Poitiers","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse - Hôpital Rangueil","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CH de Valence","city":"Valence","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie MUSSOT","phone":"+33 6 27 49 29 10","email":"jmussot@getaid.org"},{"name":"Noemie DA COSTA","phone":"+33 9 72 57 61 60","email":"ndacosta@getaid.org"}],"primaryOutcomes":["Transmural response (TR25)"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["brest-france","caen-france","clermont-ferrand-france","n-mes-france","paris-france","poitiers-france","toulouse-france","valence-france"],"enrichment":{"headline":"Phase 4: testing Mirikizumab - IV for Crohn Disease (CD)","inPlainEnglish":"How well it works of Mirikizumab to achieve transmural healing in patients with Crohn's Disease","whoItsFor":["Ages 18 Years to 75 Years","≥ 18 to ≤ 75 years-old","Symptomatic CD according to PRO-2 (stool \\> 3 or abdominal pain score \\> 1)","Transmural inflammation on baseline MRI (C-score \\> 0.5 in at least one segment)"],"whoShouldSkip":["Prior exposure to anti-p19 biological therapy","Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase \\[JAK\\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents","Exclude any previous use of p19 IL23s agents","Contra-indication to mirikizumab","Colectomy with IPAA","Isolated or uncontrolled perianal lesions","Severe obstructive symptoms"],"whatHappens":"If you join, the listed intervention(s) are Mirikizumab - IV, or Mirikizumab - SC. The registry lists allocation as na. How well it works of Mirikizumab to achieve transmural healing in patients with Crohn's Disease","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 75 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.892Z"},{"nctId":"NCT07292168","title":"A Phase 1b/2 Study of the Safety and Efficacy of the Monoclonal Antibody OM-RCA-01 in Patients With Metastatic Tumors Expressing Fibroblast Growth Factor Receptor 1","officialTitle":"A Phase 1b/2 Study Evaluating the Safety and Preliminary Efficacy of OM-RCA-01, an Anti-FGFR1 Monoclonal Antibody, in Patients With Metastatic Cancers Expressing FGFR1.","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Kidney Cancer Research Bureau","sponsorClass":"OTHER","summary":"One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.\n\nThe goal of this clinical trial is to learn if monoclonal anti-FGFR1 antibody (OM-RCA-01) works to treat metastatic cancers expressing FGFR1. It will also learn about the safety of drug OM-RCA-01. The main questions it aims to answer are:\n\n1. What medical problems do participants have when receiving drug OM-RCA-01?\n2. What dose of the drug should patients receive in the next studies?\n3. Does tumor growth slow down in patients receiving OM-RCA-01?\n\nAll patients in this study will receive the antibody treatment. The drug will be given through a vein (by IV infusion) every two weeks, for as long as the disease remains under control and the treatment is well tolerated.","conditions":["Renal Cell Carcinoma Metastatic","Prostate Cancer Metastatic","Non-small Cell Lung Cancer Metastatic","Breast Cancer Metastatic","Head & Neck Cancer"],"keywords":["metastatic cancer","resistance","monoclonal antibody","fibroblast growth factor receptor 1","OM-RCA-01","kidney cancer","prostate cancer","head & neck cancer","lung cancer","breast cancer"],"interventions":[{"type":"BIOLOGICAL","name":"humanized monoclonal anti-FGFR1 antibody OM-RCA-01"}],"enrollment":64,"startDate":"2025-12-02","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed and dated Informed Consent Form confirming voluntary participation in the study.\n2. Age ≥ 18 years at the time of consent.\n3. Body weight ≥ 50 kg.\n4. Histologically confirmed metastatic solid tumors:\n\n   1. clear-cell renal cell carcinoma;\n   2. non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);\n   3. prostate cancer (castration-resistant adenocarcinoma);\n   4. breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);\n   5. head and neck tumors (squamous carcinoma, salivary gland cancer).\n5. Immunohistochemical expression of FGFR1 of 2+ or higher.\n6. Documented disease progression after at least two lines of standard therapy, or lack of available or feasible alternative standard treatment options for any reason.\n7. Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n8. Availability of formalin-fixed and paraffin-embedded tumor tissue samples for biomarker analysis.\n9. ECOG performance status 0 or 1.\n10. Adequate organ function, confirmed by laboratory test results obtained within 7 days prior to Cycle 1 Day 1, meeting the following parameters:\n\n    * Hemoglobin level ≥ 100 g/L\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L\n    * Platelet count ≥ 100 × 10⁹/L\n    * Serum creatinine level ≤ 1.5 × upper limit of normal (ULN)\n    * Glomerular Filtration Rate (GFR) ≥ 30 mL/min\n    * AST and ALT ≤ 3 × ULN (≤ 5 × ULN in patients with liver metastases)\n    * Serum phosphorus within normal limits (≥ lower limit of normal and ≤ upper limit of normal)\n    * Serum calcium ≥ lower limit of normal\n    * Serum potassium ≥ lower limit of normal (note: use of medications to increase potassium during screening is permitted)\n11. Life expectancy of more than 12 weeks.\n12. Absence of any psychological, familial, social or geographical circumstances that could potentially serve as an obstacle to the fulfillment of the study protocol and follow-up procedures according to the prescribed schedule and the ability of the study participant to follow the requirements of the protocol; these circumstances should be discussed with the patient before inclusion in the study.\n13. Women capable of childbearing must be using an effective method of contraception.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study.\n2. Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion.\n\n   Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:\n   * No evidence of new or progressive CNS metastases\n   * No ongoing steroid therapy\n   * Stable mental status sufficient to provide informed consent\n3. History of or current evidence of any condition, therapy, or laboratory abnormality that could:\n\n   * Limit interpretation of study results,\n   * Prevent completion of the study protocol, or\n   * Pose a risk to patient safety or well-being. This includes any serious or unstable general medical, psychiatric, or other conditions potentially jeopardizing safety, informed consent, or compliance.\n4. Any second malignancy within the previous 5 years, except for adequately treated cervical carcinoma in situ, squamous cell carcinoma of the skin, or basal cell carcinoma of the skin with limited growth, provided these are well controlled.\n5. Known regular use of illicit substances or recreational drugs, or a history of drug abuse or alcoholism within the past year.\n6. Plans to conceive during the study period, current pregnancy, or lactation.\n7. Known HIV-positive status.\n8. Known active hepatitis B or C infection.\n9. Evidence of active bleeding or hemorrhagic diathesis.\n10. Radiation therapy within 14 days prior to inclusion.\n11. Receipt of any anti-tumor treatments including:\n\n    * Surgery or tumor embolization within 14 days prior to the first OM-RCA-01 dose, or\n    * Chemotherapy, immunotherapy, biological therapy, investigational therapy, or endocrine therapy (except ongoing androgen deprivation therapy for prostate cancer) within 14 days or within two half-lives of the drug (whichever is longer) prior to the first OM-RCA-01 dose.\n12. Prior treatment with any FGFR-inhibiting or FGFR-blocking agents.","locations":[{"facility":"Republican Dispensary of Tatarstan","city":"Kazan'","state":"","country":"Russia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"A.I. Kryzhanovsky Krasnoyarsk Regional Cancer Center","city":"Krasnoyarsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical","city":"Moscow","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"I.P. Pavlov First Saint Petersburg State Medical University","city":"Saint Petersburg","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Republican Clinical Oncology Dispensary","city":"Ufa","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ilya Tsimafeyeu, MD, PhD","phone":"9178914943","email":"sten_to@mail.ru"}],"primaryOutcomes":["Primary endpoint in the phase 1b study","Primary endpoint in the phase 2 study"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","kidney-cancer","als"],"drugSlugs":[],"locationSlugs":["kazan-russia","krasnoyarsk-russia","moscow-russia","saint-petersburg-russia","ufa-russia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing humanized monoclonal anti-FGFR1 antibody OM-RCA-01 for Renal Cell Carcinoma Metastatic","inPlainEnglish":"One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs). FGFR1 is the main representative of the FGFR family.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years at the time of consent","Body weight ≥ 50 kg","Histologically confirmed metastatic solid tumors:","clear-cell renal cell carcinoma;","non-small cell lung cancer (adenocarcinoma or squamous cell cancer without EGFR and ALK mutations);","prostate cancer (castration-resistant adenocarcinoma);","breast cancer (adenocarcinoma with specified status for estrogen receptors, progesterone receptors, HER2);"],"whoShouldSkip":["Participation in another clinical trial or concomitant treatment with any investigational drug, or administration of any investigational anticancer therapy within 28 days prior to inclusion in this study","Presence of central nervous system (CNS) metastases and/or medullary carcinomatosis at the time of inclusion","Exception: Patients with CNS metastases who have received therapy may participate if they have been clinically stable for at least 1 month prior to enrollment, defined by:","No evidence of new or progressive CNS metastases","No ongoing steroid therapy","History of or current evidence of any condition, therapy, or laboratory abnormality that could:","Limit interpretation of study results,"],"whatHappens":"If you join, the listed intervention(s) are humanized monoclonal anti-FGFR1 antibody OM-RCA-01. The registry lists allocation as na. One of the most relevant targets in the field of novel targeted anticancer therapy is the family of receptors to fibroblast growth factor receptors (FGFRs).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 64 people at 5 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.963Z"},{"nctId":"NCT07292480","title":"Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity","officialTitle":"Monthly Monitoring of Plasma NfL in Treated RRMS to Detect Persistent Infraclinical Disease Activity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Centre Hospitalier Universitaire de Nīmes","sponsorClass":"OTHER","summary":"Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity. When monitoring treatment response in patients treated with disease modifying treatments (DMTs), the measurement of new or enlarging T2/FLAIR hyperintense lesions (NELs) is the preferred MRI method supplemented by contrast-enhancing lesions (CELs) for monitoring treatment response. However, some studies have suggested the deposition of gadolinium-based contrast agents in the basal ganglia and dentate nucleus of patients who underwent serial MRI acquisitions. Although significant clinical consequences of these deposits have not been demonstrated, further studies are required to better understand the potential long-term biological and clinical effects of gadolinium administration. To circumvent this potential risk, several recommendations suggested avoiding unnecessary use of gadolinium for follow-up scans. New sequences are also developed to replace gadolinium injection for the detection of active lesions. Moreover, MRI remains costly and time-consuming. In addition, systematic yearly MRI monitoring is not adapted to detect silent active lesions. This can delay identification of treatment failure and increase the risk of relapses and disability worsening, especially in the context of escalation therapy.\n\nTherefore, biological markers could allow more frequent analysis of disease activity and detect treatment failure earlier than classical clinical and MRI monitoring. Their use would greatly help clinicians to switch for high efficacy treatments (HET) and avoid potential relapses.\n\nMeasurement of a structural axonal protein, neurofilament, in serum or plasma has shown promise as a marker of neuroaxonal injury and a measure of treatment response. In MS, cerebrospinal fluid (CSF) neurofilament-light chain (NfL) is also increased and is positively associated with MRI lesion load and disability scores and is a marker of treatment response.\n\nWThe study authors hypothesize that monthly plasma neurofilament-light chain (pNfL) monitoring can sensitively highlight subclinical (radiological disease activity) RDA by performing early MRI scans to confirm EDA and lead to timely treatment escalation.\n\nThe main objective of this study is to compare the time to EDA in both arms (monthly pNfL monitoring vs. standard care with regular MRI scans), in patients with EDA.","conditions":["Multiple Sclerosis (MS) - Relapsing-remitting"],"keywords":["Biomarker"],"interventions":[{"type":"OTHER","name":"Monthly pNfL monitoring"}],"enrollment":84,"startDate":"2025-12-12","completionDate":"2030-12","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient with RRMS according to 2024 McDonald's criteria.\n* Less than 10 years from disease onset.\n* Active RRMS (EDA) observed during the last 24 months: relapse and/or NELs and/or CELs as compared to a previous MRI performed within 24 months (± 3 months).\n* Current MET (IFN, GA, TE, fumarates) for less than 24 months.\n* Standard MRI follow-up scan performed less than 90 days before inclusion.\n* Clinically stable disease for at least 30 days.\n* Patients included in observational studies and cohorts (OFSEP, PROMISE …) will be eligible for inclusion in MoMo-NfL.\n* For women with reproductive potential: negative pregnancy test at the time of inclusion and use of an effective method to avoid pregnancy for the duration of the trial.\n* Patients able to adhere to the study visit schedule.\n* Patient must have signed and given the consent.\n* Patient affiliated or beneficiary of a health insurance plan.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding woman.\n* Patient unable to perform brain and/or spinal cord MRI scans.\n* Patient not willing to perform monthly blood punctures.\n* Patient treated with HET (S1P agonists, natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine, mitoxantrone).\n* Patient with a relapse within 6 months before inclusion.\n* Patient with CELs within 3 months before inclusion.\n* Patient with progressive MS.\n* Patient unable to sign the consent.\n* It is impossible to correctly inform the patient.\n* Patient already participating in therapeutic research or in an exclusion period. The exclusion period corresponds to five half-lives (t1/2) of the experimental drug.\n* Patient under judicial protection, or is an adult under guardianship.\n* Female patients who are pregnant or breastfeeding or of reproductive potential who are not willing to employ effective birth control for the duration of the trial.","locations":[{"facility":"CHU de Montpellier - Hôpital Guy de Chauliac","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nantes","city":"Nantes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nice","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Nîmes","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HP, Hôpital de la Pitié Salpêtrière","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Rennes","city":"Rennes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric Thouvenot","phone":"04 66 68 32 61","email":"eric.thouvenot@chu-nimes.fr"}],"primaryOutcomes":["Time to evidence of disease activity between groups","Time to evidence of disease activity between groups"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["montpellier-france","nantes-france","nice-france","n-mes-france","paris-france","rennes-france"],"enrichment":{"headline":"Not a traditional drug phase: Monthly pNfL monitoring for Multiple Sclerosis (MS) - Relapsing-remitting","inPlainEnglish":"Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity. When monitoring treatment response in patients treated with disease modifying treatments (DMTs), the measurement of new or enlarging T2/FLAIR hyperintense lesions (NELs) is the preferred MRI method supplemented by contrast-enhancing lesions (CELs) for monitoring treatment response.","whoItsFor":["Ages 18 Years to 55 Years","Patient with RRMS according to 2024 McDonald's criteria","Less than 10 years from disease onset","Active RRMS (EDA) observed during the last 24 months: relapse and/or NELs and/or CELs as compared to a previous MRI performed within 24 months (± 3 months)","Current MET (IFN, GA, TE, fumarates) for less than 24 months","Standard MRI follow-up scan performed less than 90 days before inclusion","Clinically stable disease for at least 30 days","Patients included in watch-and-measure (no experimental treatment required) studies and cohorts (OFSEP, PROMISE …) will be eligible for inclusion in MoMo-NfL"],"whoShouldSkip":["Pregnant or breastfeeding woman","Patient unable to perform brain and/or spinal cord MRI scans","Patient not willing to perform monthly blood punctures","Patient treated with HET (S1P agonists, natalizumab, ocrelizumab, ofatumumab, rituximab, alemtuzumab, cladribine, mitoxantrone)","Patient with a relapse within 6 months before inclusion","Patient with CELs within 3 months before inclusion","Patient with progressive MS"],"whatHappens":"If you join, the listed intervention(s) are Monthly pNfL monitoring. The registry lists allocation as randomized. Reference MRI scan is recommended 6 months after treatment onset in patients with multiple sclerosis (MS), and follow-up scans at 12 months later to monitor subclinical activity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 84 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.976Z"},{"nctId":"NCT07293715","title":"Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM)","officialTitle":"Permissive Versus Strict Intrapartum Glucose Management in Type 1 and Type 2 Diabetes (PRISM)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ohio State University","sponsorClass":"OTHER","summary":"PRISM is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.","conditions":["Pregnancy, High Risk","Type 1 Diabetes","Type 2 Diabetes"],"keywords":["Pregnancy","Continuous Glucose Monitor","Type 1 Diabetes","Automated insulin delivery","Hybrid closed loop","Insulin pump","Type 2 Diabetes"],"interventions":[{"type":"DRUG","name":"Insulin"},{"type":"DEVICE","name":"DEXCOM Continuous Glucose Monitor"}],"enrollment":44,"startDate":"2026-02-25","completionDate":"2027-06","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Pregnant individuals\n* ≥ 18 years old\n* Type 1 and Type 2 diabetes\n* Intention for vaginal delivery and admitted to Labor and Delivery\n* Singleton, non-anomalous fetus\n* Gestational age greater than or equal to 35 weeks gestation.\n* Cervical dilation is less than 6 cm.\n* Delivering at the study institution\n\nExclusion criteria:\n\n* Scheduled cesarean delivery\n* Cervical dilation ≥ 6 cm on presentation to L\\&D\n* Receipt of antenatal corticosteroids within 7 days of randomization\n* Fetal demise\n* Major fetal anomaly (attached)\n* Multiple gestation\n* Non-English speaking","locations":[{"facility":"The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Brewton, MD","phone":"614-293-8045","email":"Anna.Brewton@osumc.edu"}],"primaryOutcomes":["Mean of first neonatal blood glucose (continuous, mean with standard deviation)"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Phase 4: testing Insulin for Pregnancy, High Risk","inPlainEnglish":"PRISM is a single center non-inferiority randomly assigned controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management. you would be randomly assigned in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL).","whoItsFor":["Ages 18 Years to any","Women only","Pregnant individuals","Type 1 and Type 2 diabetes","Intention for vaginal delivery and admitted to Labor and Delivery","Singleton, non-anomalous fetus","Gestational age greater than or equal to 35 weeks gestation","Cervical dilation is less than 6 cm","Delivering at the study institution"],"whoShouldSkip":["Scheduled cesarean delivery","Cervical dilation ≥ 6 cm on presentation to L\\&D","Receipt of antenatal corticosteroids within 7 days of randomization","Major fetal anomaly (attached)","Non-English speaking"],"whatHappens":"If you join, the listed intervention(s) are Insulin, or DEXCOM Continuous Glucose Monitor. The registry lists allocation as randomized. PRISM is a single center non-inferiority randomly assigned controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with pregestational diabetes using hybrid closed loop therapy (HCL) who are admitted for labor management.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 44 people at Columbus. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.521Z"},{"nctId":"NCT07295821","title":"Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study","officialTitle":"Phase II, Single-arm Multicenter Study of Osimertinib Induction Before Radiotherapy and Maintenance in Chemo-ineligible or Refusing Patients With Stage III, Unresectable NSCLC and EGFR Mutation-positive Tumors","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure efficacy and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).","conditions":["Lung Cancer"],"keywords":["NSCLC"],"interventions":[{"type":"DRUG","name":"Osimertinib"}],"enrollment":60,"startDate":"2026-04-01","completionDate":"2029-05-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent form.\n2. Participants with histologically documented NSCLC of predominantly nonsquamous, squamous, and adenosquamous pathology who present with locally advanced, unresectable (Stage III, according to Version 8 of the IASLC Staging Manual in Thoracic Oncology) disease. It is recommended but not required that except for overt cT4 disease, nodal status N2, or N3 should have been proven by biopsy, via endobronchial ultrasound, mediastinoscopy, thoracoscopy, or in absence of biopsy, should have been confirmed with whole body contrast-enhanced CT.\n3. Participants who had recurred from Stage I/II/III after complete surgery or had gross incomplete resections can be included if they didn't receive treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents.\n4. Participants with availability of the EGFRm test results confirming that the tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo T790M\n5. WHO performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose.\n6. Participants who are eligible for and planning to undergo RT treatment per physician assessment.\n7. Participant refusal or ineligible for chemotherapy per physician assessment.\n8. Minimum life expectancy of \\> 12 weeks at Day 1.\n9. At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.\n10. Capable of giving signed informed consent as described which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n\nExclusion Criteria\n\n1. Any presence of small cell and mixed small-cell and non-small cell histology.\n2. Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.\n3. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the participant to participate in the trial or which would jeopardize compliance with the protocol, or active infection.\n4. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib.\n5. History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non-melanoma skin cancer and curatively treated in situ disease. Patients who have received RT with overlapping fields (eg, cured breast cancer) should be excluded.\n6. Patient meets any of the following cardiac criteria: Mean resting QTc \\> 470 msec, obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value. Hypomagnesaemia and hypocalcaemia are acceptable at screening if ≤ CTCAE Grade 1. Values \\> Grade 1 for magnesium or calcium should be corrected to ≤ Grade 1 prior to first dose, with documentation of the correction attempt.\n7. Inadequate bone marrow reserve or organ function.\n8. Patients who are currently taking strong CYP3A4 inducers and cannot discontinue them at least 3 weeks before the first study dose must be excluded. This is because strong CYP3A4 inducers can decrease the exposure of osimertinib.\n9. Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy.\n10. Prior treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents for locally advanced, unresectable Stage III NSCLC. Prior surgical resection (ie, Stage I, II, or III) with no systemic treatment with residual disease or a recurrence is permitted.\n11. Prior exposure to EGFR-TKI therapy.\n12. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n13. Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks.\n14. History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.\n15. History of hypersensitivity to active or inactive excipients of RT.\n16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n17. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n18. Previous enrolment in the present study. Rescreening of individuals who were screen failures is allowed.\n19. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.\n20. Patients should refrain from breastfeeding from enrolment throughout the study and until 6 weeks after last dose of study intervention.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changchun","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Foshan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Harbin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hefei","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kunming","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Qingdao","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wenzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["PFS (Progression-Free Survival)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["beijing-china","changchun-china","changsha-china","chengdu-china","foshan-china","fuzhou-china","guangzhou-china","harbin-china","hefei-china","jinan-china","kunming-china","nanchang-china","qingdao-china","shanghai-china","taiyuan-china","wenzhou-china","xuzhou-china"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Lung Cancer","inPlainEnglish":"This study wants to measure how well it works and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).","whoItsFor":["Ages 18 Years to any","Participants who had recurred from Stage I/II/III after complete surgery or had gross incomplete resections can be included if they didn't receive treatment with any chemotherapy, radiation therapy, immunotherapy, targeted therapy, or investigational agents","Participants with availability of the EGFRm test results confirming that the tumor harbors 1 of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations including de novo T790M","WHO performance status of 0, 1 or 2 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to first dose","Participants who are eligible for and planning to undergo RT treatment per physician assessment","Participant refusal or ineligible for chemotherapy per physician assessment","Minimum life expectancy of \\> 12 weeks at Day 1","At least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements"],"whoShouldSkip":["Any presence of small cell and mixed small-cell and non-small cell histology","Past medical history of ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening","Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of osimertinib","Inadequate bone marrow reserve or organ function","Patients who are currently taking strong CYP3A4 inducers and cannot discontinue them at least 3 weeks before the first study dose must be excluded. This is because strong CYP3A4 inducers can decrease the exposure of osimertinib","Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy","Prior exposure to EGFR-TKI therapy"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib. The registry lists allocation as na. This study wants to measure how well it works and safety of osimertinib as induction therapy prior to curative intent RT and maintenance osimertinib in chemotherapy ineligible or refusal adult patients with Stage III, unresectable NSCLC with common EGFR mutations (exon 19 deletion or L858R).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.677Z"},{"nctId":"NCT07295847","title":"A Study of AZD0120 in Autoimmune Diseases","officialTitle":"A Phase 1b/2, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).","conditions":["Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Rheumatoid Arthritis"],"keywords":["Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Rheumatoid Arthritis","CAR-T","BCMA","CD19"],"interventions":[{"type":"BIOLOGICAL","name":"AZD0120"},{"type":"DRUG","name":"SOC"}],"enrollment":27,"startDate":"2026-01-09","completionDate":"2028-02-22","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* Adequate physiological function and reserve at screening.\n* Able to comply with recommended medication washout period.\n* Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator.\n* Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria.\n* Particpant musy be 18-years-old to ≤ 75-years-old inclusive at the time of signing the informed consent\n* Others as described in Clinical Study Protocol\n\nExclusion Criteria:\n\n* Any prior CAR T exposure.\n* Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 administration.\n* Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list.\n* Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening.\n* Has certain cardiac conditions that could make it unsafe or unsuitable to take part in the study.\n* Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.\n* Uncontrolled hypertension (\\> 160/100 mmHg) or symptomatic hypertension.\n* Any central nervous system disease that may impact participants safety in the investigator's opinion.\n* Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor.\n* Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening\n* History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted.\n* Known genetic inborn error of immunity and/or primary immunodeficiency.\n* Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening.\n* Seropositive for HIV or HTLV.\n* Active viral hepatitis are excluded.\n* Active syphilis, positive for Treponema pallidum antibody.\n* Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.\n* Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals.\n* Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide.\n* Contraindications or hypersensitivity to fludarabine and cyclophosphamide.\n* \\- Major surgery within 8 weeks prior to apheresis or has surgery planned during the study.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later).\n* Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant.\n* Other protocol-defined eligibility criteria may apply.","locations":[{"facility":"Research Site","city":"Tucson","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Duarte","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Stanford","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Seattle","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Clayton","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Darlinghurst","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Waratah","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Erlangen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jena","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mainz","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Würzburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huddinge","state":"","country":"Sweden","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)","Proportion of Participants Achieving a Revised-CRISS Response","Proportion of participants achieving TIS response and low corticosteroid dose","Proportion of participants achieving Disease Activity Score 28 C reactive protein (DAS28-CRP) < 2.6"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":["car-t"],"locationSlugs":["tucson-arizona","duarte-california","stanford-california","miami-florida","chicago-illinois","baltimore-maryland","ann-arbor-michigan","st-louis-missouri","new-york-new-york","chapel-hill-north-carolina","seattle-washington","clayton-australia","darlinghurst-australia","waratah-australia","berlin-germany","erlangen-germany","hamburg-germany","jena-germany","mainz-germany","w-rzburg-germany","barcelona-spain","madrid-spain","huddinge-sweden","edinburgh-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing AZD0120 for Systemic Sclerosis","inPlainEnglish":"This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to measure the whether it is safe and how hard side effects are to live with in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).","whoItsFor":["Ages 18 Years to 75 Years","Adequate physiological function and reserve at screening","Able to comply with recommended medication washout period","Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator","Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria","Others as described in Clinical Study Protocol"],"whoShouldSkip":["Any prior CAR T exposure","Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 administration","Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list","Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening","Has certain cardiac conditions that could make it unsafe or unsuitable to take part in the study","Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation","Uncontrolled hypertension (\\> 160/100 mmHg) or symptomatic hypertension"],"whatHappens":"If you join, the listed intervention(s) are AZD0120, or SOC. The registry lists allocation as na. This trial is a Phase 1b/2, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to measure the whether it is safe and how hard side effects are to live with in adult participants with systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 27 people at 25 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.968Z"},{"nctId":"NCT07296328","title":"Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter","officialTitle":"Effects of Psilocybin on Speech Fluency, Struggle, and Brain Activity in People Who Stutter","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to evaluate the safety, feasibility, and preliminary efficacy of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical outcomes in individuals who stutter, is warranted. The aims of this study include:\n\n* Aim 1: Assess the safety and feasibility of psilocybin as a therapeutic agent for stuttering.\n* Aim 2: Evaluate the effects of psilocybin on objective and subjective measures of stuttering severity, struggle, and well-being.\n* Aim 3: Explore the therapeutic neural mechanisms of psilocybin in stuttering.","conditions":["Stuttering"],"keywords":["Stuttering","Psilocybin","Stutter"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"BEHAVIORAL","name":"Speech therapy"}],"enrollment":25,"startDate":"2026-05-07","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Are able to provide voluntary informed consent\n* Are able to read, speak, and understand English, as documented during the informed consent process.\n\n  o Non-English-speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments.\n* Are 18 to 50 years old, inclusive, at Screening visit.\n* Have diagnosis of mild-moderate to severe stuttering based on either the SSI-4 or OASES; also confirmed stuttering by stuttering specialist.\n* Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments.\n* Agree to refrain from any non-prescribed psychotropic substance or illicit drug use for at least 72 hours prior to investigational product (IP) administration, and for at least 24 hours before each fMRI assessment visit, with the exceptions of nicotine and caffeine. Regarding nicotine, they must agree not to use nicotine for at least 1 hour before and 6 hours following IP administration, and for at least 1 hour before fMRI scans. Regarding caffeine, they must agree to consume approximately their usual amount of caffeine on the morning of Day 0 (prior to IP administration).\n* Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.\n* Can swallow capsules.\n* Subjects who are able to become pregnant must comply with the following conditions:\n\nA. Subjects are considered able to become pregnant unless they\n\n1. Do not have a uterus;\n2. Are postmenopausal (has had 12 months of natural amenorrhea with a matching clinical profile \\[age, history of vasomotor symptoms\\]) prior to Screening Part 2; or\n3. Are surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).\n\nB. Subjects who are able to become pregnant must\n\n1. Have a negative pregnancy test at Screening (Reassessed at Day 0 (pre-IP administration);\n2. Not be currently breastfeeding;\n3. Not intend to become pregnant during participation in this study;\n4. Agree to use a highly effective form of contraception from the time of Screening until 7 days after the IP Administration Session. Highly effective forms of contraception include:\n\n   1. Consistent and correct usage of established oral contraception;\n   2. Injected or implanted hormonal methods of contraception;\n   3. Established intrauterine device or intrauterine system;\n   4. Bilateral tubal ligation;\n   5. Intercourse with a partner who has undergone effective surgical sterilization, provided that partner is the sole sexual partner of the study subject;\n   6. Abstinence from penile/vaginal intercourse, if the Investigator determines that the subject can reliably adhere to the plan, based on evaluation of the participant's preferred and usual lifestyle and social circumstances.\n5. Agree not to donate or bank eggs from the time of Screening Part 2 until 7 days after the IP Administration Session.\n\nIf able to become pregnant or produce viable sperm (male or female), are willing to use approved contraception for duration of the trial.\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests:\n\n  * Seizure disorder\n  * Significantly impaired liver function, defined as 1) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN); 2) ALT or AST \\> 3 × ULN with concomitant total bilirubin \\> 2.0 × ULN; or 3) ALT or AST ≥ 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia.\n  * Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack.\n  * Uncontrolled hypertension with systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg. (Note: participants who otherwise meet all eligibility criteria during the screening visit will have 3 opportunities to produce 1 blood pressure reading ≤ 140/90 mmHg (each reading will be collected at least 15 minutes apart). If blood pressure at Screening is consistently elevated (\\> 140/90 mmHg across all 3 attempts), participants may be referred to their primary care provider (PCP) for management of hypertension. Participants may continue study participation if the Investigator believes that it is likely that hypertension can be controlled prior to the IP administration session, and the patient is able to provide documentation of adequate control (BP \\< 140/90 mmHg) prior to the PI administration session.)\n  * Resting heart rate \\> 100 bpm (Note: participants will have an opportunity to return once within the 30-day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.).\n  * Serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.450 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia.\n  * Hyperthyroidism\n  * Insulin-dependent diabetes\n  * Bradycardia (e.g., heart rate \\<50 bpm)\n  * Orthostatic hypotension\n  * Schizotypal and paranoid personality disorders\n  * Given potential use of diazepam as an ancillary medication, moderate or greater hepatic impairment (Child-Pugh score ≥ 7) is exclusionary.\n  * Any other medical condition which precludes safe participation in the study in the medical opinion of the Investigator. (Note: medical history will be updated on Day 0. Those not meeting the criterion may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator.)\n* Have any of the following Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) psychiatric disorders, as determined by the Mini International Neuropsychiatric Interview (MINI) and Psychiatric History at the Screening Visit: (Note: psychiatric history will be re-evaluated on Day 0, but the MINI will not be re-administered on Day 0)\n\n  * Lifetime history of schizophrenia spectrum or other psychotic disorder (including substance or medication-induced psychosis or psychosis due to a co-occurring medical condition).\n  * Major depressive disorder (MDD)Post traumatic stress disorder (PTSD)\n  * Cluster B personality disorders (antisocial personality disorder, borderline personality disorder, histrionic personality disorder, and narcissistic personality disorder)\n  * Bipolar I disorder, Bipolar II disorder, and Cyclothymic disorder\n* Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS) assessment (severity score \\> 3) at the Screening visit, confirmed by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0. Participants will be discharged if actively suicidal, and appropriate follow-up will be arranged.\n* Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator. (Note: this criterion will be reassessed at each visit that occurs prior to Day 0, and on Day 0. Participants will be discharged if actively suicidal, and appropriate follow-up will be arranged.)\n* Have a family history (first degree relatives) of schizophrenia, schizoaffective disorder, or bipolar disorder type 1.\n* Have a history of hallucinogen use disorder.\n* Have a history of hallucinogen persisting perceptual disorder (HPPD).\n* Have any use of classic psychedelics in the past 1 year.\n* Have \\> 25 lifetime uses of classic psychedelics.\n* Incarcerated or have pending legal action that could prevent participation in study activities.\n* Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements. (A detailed list of exclusionary medications is found in Section 6.5 of the protocol.) Prohibited medications and supplements must have been stopped for at least 5 elimination half-lives or 14 days, whichever is longer, prior to Day 0 (Note: Psychiatric medications will not be discontinued or changed in order to allow study participation. Concomitant medications will be reassessed on Day 0. Any patient who has started prohibited medications will be discharged from the study.)\n* Have a known allergy or hypersensitivity to psilocybin or any of the materials contained in the IP used in the study.\n* Have an allergy, hypersensitivity, or other contraindication that would preclude safe treatment of acute hypertension, anxiety, or psychotic symptoms if necessary, during or immediately after the IP Administration Session, using the adjunctive medications used in this pilot study to treat these symptoms (i.e., unable to take captopril and unable to take clonidine; unable to take diazepam; or unable to take olanzapine).\n* Have any other medical, psychiatric, or psychosocial disorder, symptom, condition, or situation that is likely to interfere with the establishment of rapport, adherence to study requirements, or safe administration of psilocybin or functional magnetic resonance imaging (fMRI) scanning, based on the judgement of the Investigator. (Note: This criterion will be reassessed on Day 0. Those not meeting the criterion will not be randomized but may be rescheduled once within 14 days if the criterion is likely to resolve within 14 days in the judgement of the Investigator.)\n* Inability to safely complete fMRI sessions (MRI screening form)\n* Any history of severe traumatic brain injury (assessed using the Ohio State University Traumatic Brain Injury Identification Method (OSU TBI-ID) modified). (Note: If current (past 12 months) mild/moderate Traumatic Brain Injury (TBI) and Central Sensitization Inventory (CSI) score \\>/= 12 (for either lifetime month or current month), the PI will determine eligibility.)","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eric Jackson, PhD","phone":"212-992-9470","email":"Ej34@nyu.edu"}],"primaryOutcomes":["Change in Stuttering Severity Instrument - 4th Edition (SSI-4) total score","Change in frequency subcomponent score of the SSI-4","Change in duration subcomponent score of the SSI-4","Change in physical concomitants subcomponent score of the SSI-4","Change in Overall Assessment of the Speaker's Experience of Stuttering - Adults (OASES-A) score"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["psilocybin"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Psilocybin for Stuttering","inPlainEnglish":"This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to measure the safety, feasibility, and preliminary how well it works of psilocybin as a therapeutic intervention for adults with developmental stuttering. This pilot study will assess whether further research to explore the potential benefits of psilocybin-assisted therapy for improving clinical outcomes in individuals who stutter, is warranted.","whoItsFor":["Ages 18 Years to 50 Years","o Non-English-speaking subjects will be excluded because the study is using only validated English-language versions of assessment instruments","Are 18 to 50 years old, inclusive, at Screening visit","Have diagnosis of mild-moderate to severe stuttering based on either the SSI-4 or OASES; also confirmed stuttering by stuttering specialist","Are able and willing to adhere to all study requirements, including attending all study visits and therapy sessions, and completing all assessments","Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator","Can swallow capsules","Subjects who are able to become pregnant must comply with the following conditions:"],"whoShouldSkip":["Pregnancy or lactation","Any medical condition that would preclude safe participation in the study, including the following, as determined by medical history review, physical examination, electrocardiogram (ECG), and clinical laboratory tests:","Cardiovascular disease including coronary artery disease, angina, history of arrhythmia (unless a successful ablation has been performed), heart failure, history of heart valve replacement, and history of cerebrovascular accident or transient ischemic attack","Resting heart rate \\> 100 bpm (Note: participants will have an opportunity to return once within the 30-day screening window to make 3 additional attempts at a resting heart rate ≤ 100 bpm.)","Serious ECG abnormalities (e.g., evidence of ischemia, myocardial infarction, QT interval corrected for heart rate \\[QTc\\] prolongation (QTc \\> 0.450 seconds), arrhythmia, or conduction abnormalities that increase the risk of arrhythmia","Insulin-dependent diabetes","Bradycardia (e.g., heart rate \\<50 bpm)"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, or Speech therapy. The registry lists allocation as na. This Phase 2a clinical trial is an open-label, single-group, within-subjects pilot study designed to measure the safety, feasibility, and preliminary how well it works of psilocybin as a therapeutic intervention for adults with developmental stuttering.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 25 people at New York. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.091Z"},{"nctId":"NCT07297212","title":"A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma","officialTitle":"A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BioNTech SE","sponsorClass":"INDUSTRY","summary":"This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.","conditions":["Recurrent Glioblastoma"],"keywords":["Bispecific antibody","Immunotherapy","Immunotherapy in combination with chemotherapy","Brain tumor","Programmed death-ligand 1 (PD-L1)","Vascular endothelial growth factor(-A) (VEGF-A)"],"interventions":[{"type":"DRUG","name":"Pumitamig"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Temozolomide"}],"enrollment":75,"startDate":"2026-01-15","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Adults, aged 18 to 75 years inclusive at the time of giving informed consent. Local laws will be followed in countries where adulthood is defined as older than 18 years.\n* Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria.\n* Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide. Exception: For participants who discontinued temozolomide or switched to an alternative treatment prior to disease recurrence due to temozolomide intolerance, an interval of ≥6 months between the completion of radiotherapy and first disease recurrence is acceptable.\n* Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field.\n* Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria.\n* Have KPS ≥60.\n* Can swallow the medication and maintain oral administration.\n* Have a baseline brain MRI, not more than 14 days before starting the study treatment.\n* Have a stable dose of steroids ≥7 days before the contrast-enhanced scan.\n* Have adequate organ function, as defined in the protocol.\n\nKey Exclusion Criteria:\n\n* Have received any of the following therapies or drugs before study enrollment:\n\n  * Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment. For bevacizumab, the washout period is 4 weeks before the first dose of study treatment.\n  * Programmed death-1 / programmed death-ligand 1/vascular endothelial growth factor bispecific antibodies, cluster of differentiation 137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof.\n  * Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment.\n  * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment.\n  * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment.\n  * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study.\n  * Antiplatelet drugs, such as aspirin (\\>325 mg/day), clopidogrel (\\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study.\n* Have had more than one recurrence of GBM.\n* Are allergic to dacarbazine and temozolomide.\n* Have known leptomeningeal disease, extracranial disease, or multicentric disease.\n* Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma).\n* Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation).\n* Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded.\n* Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment.\n* Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI.\n* Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment prior to the initiation of study treatment.\n* Have received allogeneic hematopoietic stem cell transplantation or organ transplantation.\n* Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer).\n* Have any of the following heart conditions within 6 months before starting the study treatment:\n\n  * Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events.\n  * New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction \\<50%.\n  * Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia/atrial fibrillation are allowed.\n  * Mean QT interval corrected by Fridericia's method (QTcF) \\>480 ms (the electrocardiogram can be repeated at the discretion of the investigator).\n  * Cardiac troponin I or T \\>2 × upper limit normal.\n* Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.\n* Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders.\n* Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed.\n* Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy).\n* Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment.\n* History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment.\n* Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator.\n* Have superior vena cava syndrome or symptoms of spinal cord compression.\n* Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease.\n* Have a known history of tuberculosis that was not successfully treated.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Beijing Tiantan Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Tumor Hospital of Chongqing Medical University","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Cancer Hospital of Shandong First Medical University","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Second People's Hospital","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BioNTech clinical trials patient information","phone":"+49 6131 9084","email":"patients@biontech.de"}],"primaryOutcomes":["Confirmed overall response rate (ORR)","Occurrence of treatment emergent adverse events (TEAEs) by severity","Occurrence of dose interruptions, reductions or discontinuations of study treatment due to TEAEs"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["beijing-china","chongqing-china","jinan-china","shanghai-china","shenzhen-china","wuhan-china"],"enrichment":{"headline":"Phase 2: testing Pumitamig for Recurrent Glioblastoma","inPlainEnglish":"This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.","whoItsFor":["Ages 18 Years to 75 Years","Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria","Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria","Can swallow the medication and maintain oral administration","Have a baseline brain MRI, not more than 14 days before starting the study treatment","Have a stable dose of steroids ≥7 days before the contrast-enhanced scan","Have adequate organ function, as defined in the protocol"],"whoShouldSkip":["Have received any of the following therapies or drugs before study enrollment:","Programmed death-1 / programmed death-ligand 1/vascular endothelial growth factor bispecific antibodies, cluster of differentiation 137 agonists or other immune checkpoint blockade therapies including this drug alone with either category or combinations thereof","Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment","Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment","Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment","Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another treatment clinical study","Antiplatelet drugs, such as aspirin (\\>325 mg/day), clopidogrel (\\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study"],"whatHappens":"If you join, the listed intervention(s) are Pumitamig, Bevacizumab, or Temozolomide. The registry lists allocation as randomized. This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 75 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.488Z"},{"nctId":"NCT07298005","title":"Sonlicromanol in Post-COVID","officialTitle":"SON4PEM Study: Sonlicromanol in Post-COVID: A Randomized, Double-blind, Placebo-controlled, Phase II Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Michele van Vugt","sponsorClass":"OTHER","summary":"The aim of this randomized, double-blind, placebo-controlled, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).","conditions":["Post COVID Condition"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sonlicromanol"},{"type":"DRUG","name":"Placebo"}],"enrollment":80,"startDate":"2026-04-03","completionDate":"2027-02","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Post COVID according to WHO criteria and verified by post COVID physician\n* Post-exertional malaise (PEM) according to DSQ-PEM questionnaire\n* Bell's disability score 20-70%\n* Mild initial SARS-CoV-2 infection (no hospitalisation)\n* WHO performance score of 0 before initial SARS-CoV-2 infection\n\nExclusion Criteria:\n\n* Patients at risk for cardiac conduction disorders\n* History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP\n* Clinically significant respiratory or cardiovascular disease\n* Unstable neurological disease\n* Clinically significant active psychiatric disorder that requires treatment\n* History of substance abuse\n* Active malignancy within the past 5 years\n* History of solid organ transplantation\n* Active HIV, hepatitis B or C infection\n* BMI \\< 18.5 or \\> 35\n* Pregnancy or breastfeeding\n* Clinically relevant laboratory test value outside the reference range\n* Use of the following medication, unless stable for at least one month before study and remaining stable throughout the study: (multi)vitamins, co-enzyme Q10, Vitamin E, riboflavin, amino acids, antioxidant supplements and any medication negatively influencing mitochondrial functioning (including but not limited to valproic acid, glitazones, statins, antivirals, amiodarone and NSAIDs)\n* Use of the following medication: any moderate or strong Cytochrome P450 (CYP)3A4 inhibitors (all 'conazoles-anti-fungals', HIV antivirals, grapefruit), strong CYP3A4 inducers ((including HIV antivirals, carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort, pioglitazone, troglitazone) or any medication metabolized by CYP3A4 with a narrow therapeutic index, medication known to be substrate of Organic Cation Transporter 1 (OCT1) and organic cation transporter 2 (OCT2) or strong P-glycoprotein inhibitors (including amiodarone, azithromycin, captopril, clarithromycin, cyclosporine, piperine, quercetin, quinidine, quinine, reserpine, ritonavir, tariquidar, and verapamil).\n* Use of any medication known to affect cardiac repolarization unless QTc interval at screening is normal during stable treatment for a period of two weeks, or 5 half-lives","locations":[{"facility":"Amsterdam University Medical Center, Location Academic Medical Center (AMC)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Fatigue"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["amsterdam-netherlands"],"enrichment":{"headline":"Phase 2: testing Sonlicromanol for Post COVID Condition","inPlainEnglish":"The aim of this randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).","whoItsFor":["Ages 18 Years to 65 Years","Post COVID according to WHO criteria and verified by post COVID physician","Post-exertional malaise (PEM) according to DSQ-PEM questionnaire","Bell's disability score 20-70%","Mild initial SARS-CoV-2 infection (no hospitalisation)","WHO performance score of 0 before initial SARS-CoV-2 infection"],"whoShouldSkip":["Patients at risk for cardiac conduction disorders","History of clinical significant gastro-intestinal surgery or dysmotility that impairs the adsorption of the IMP","Clinically significant respiratory or cardiovascular disease","Unstable neurological disease","Clinically significant active psychiatric disorder that requires treatment","History of substance abuse","Active malignancy within the past 5 years"],"whatHappens":"If you join, the listed intervention(s) are Sonlicromanol, or Placebo. The registry lists allocation as randomized. The aim of this randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, phase II trial, is to study the effect of sonlicromanol on fatigue in patients with post-COVID who experience post-exertional malaise (PEM).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at Amsterdam. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.244Z"},{"nctId":"NCT07298421","title":"A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).","conditions":["Moderately to Severely Active Crohns Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Afimkibart"}],"enrollment":100,"startDate":"2026-08-18","completionDate":"2030-05-31","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Body weight \\>= 10 kilogram (kg)\n* Active CD confirmed by endoscopy (ileocolonoscopy)\n* Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \\>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \\>=6 (or \\>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy\n* Inadequate response, loss of response, and/or intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and/or immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)\n* History of \\>= 3 bowel resections: \\> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum\n* Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n* Symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Current diagnosis or suspicion of primary sclerosing cholangitis","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Digestive Specialists","city":"Harlingen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Hospital Brisbane","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Children's Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perth Children's Hospital","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Santa Casa de Misericordia de Porto Alegre","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CECIP - Centro de Estudos Clínicos do Interior Paulista","city":"Jaú","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"BR Trials - Pesquisa Clínica","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigación Clínica Acelerada, S.C","city":"Mexico City","state":"Mexico CITY (federal District)","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"FAICIC Clinical Research","city":"Veracruz","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emmed Research","city":"Pretoria","state":"Gauteng","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"IATROS International","city":"Bloemfontein","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chulalongkorn University","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siriraj Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Children's Hospital","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheffield Childrens Hospital","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CP45906 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With Clinical Remission per Pediatric Crohn's Disease Activity Index (PCDAI)","Percentage of Participants With Endoscopic Response"],"hasResults":false,"conditionSlugs":["als","crohns-disease"],"drugSlugs":[],"locationSlugs":["new-york-new-york","harlingen-texas","south-brisbane-australia","parkville-australia","nedlands-australia","porto-alegre-brazil","ja-brazil","s-o-paulo-brazil","mexico-city-mexico","veracruz-mexico","pretoria-south-africa","bloemfontein-south-africa","taipei-taiwan","bangkok-thailand","birmingham-united-kingdom","london-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Afimkibart for Moderately to Severely Active Crohns Disease","inPlainEnglish":"This phase III, neither you nor the study doctors know who gets the real treatment, multi-center treat-through study will measure the how well it works and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).","whoItsFor":["Ages 2 Years to 17 Years","Body weight \\>= 10 kilogram (kg)","Active CD confirmed by endoscopy (ileocolonoscopy)","Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \\>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \\>=6 (or \\>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy"],"whoShouldSkip":["Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)","History of \\>= 3 bowel resections: \\> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum","Current diagnosis of ulcerative colitis (UC), abdominal/intraabdominal/perianal fistula and/or abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease","Symptomatic bowel strictures, fulminant colitis, or toxic megacolon","Presence of abdominal or perianal abscess","Current diagnosis or suspicion of primary sclerosing cholangitis"],"whatHappens":"If you join, the listed intervention(s) are Afimkibart. The registry lists allocation as randomized. This phase III, neither you nor the study doctors know who gets the real treatment, multi-center treat-through study will measure the how well it works and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 100 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.888Z"},{"nctId":"NCT07299019","title":"A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis","officialTitle":"A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-active Secondary Progressive Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Zenas BioPharma (USA), LLC","sponsorClass":"INDUSTRY","summary":"Orelabrutinib is a CNS-penetrable BTK inhibitor. This is a phase 3, randomized, double-blind, parallel-group, multicenter study to evaluate the efficacy and safety of orelabrutinib compared with placebo in patients with non-active Secondary Progress MS. Patients will be treated for approximately 24 to 60 months, with a minimum treatment duration of 12 months. The study will enroll approximately 990 subjects in a 2:1 randomization (orelabrutinib: placebo), globally.","conditions":["Secondary Progressive Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Orelabrutinib"},{"type":"DRUG","name":"Placebo"}],"enrollment":990,"startDate":"2026-03-23","completionDate":"2030-06","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 18 to 60 years of age, inclusive, at the time of signing the informed consent.\n2. Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria\n3. Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013\n4. Participant must have documented evidence of disability progression independent of clinical relapse observed during the 24 months before screening. A written summary of the clinical evidence of disability progression must be discussed and aligned between the Investigator and the Sponsor's dedicated qualified person(s).\n5. Absence of clinical relapses for at least 24 months.\n\nExclusion Criteria:\n\n1. The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria\n2. Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy.\n3. History or current diagnosis of other neurological disorders that may mimic MS\n4. History or current diagnosis of progressive multifocal leukoencephalopathy\n5. Active, clinically significant viral, bacterial, or fungal infection\n6. History of any other significant active medical condition\n7. History of suicidal behavior within 6 months prior to Screening\n8. Any prior history of malignancy\n9. Patients on anticoagulation, or antiplatelet therapy\n10. Patients took strong/moderate CYP3A inhibitors or strong/moderate CYP3A inducers within 14 days\n11. Clinically significant laboratory abnormalities at Screening.\n12. Vaccination with live or live-attenuated virus vaccine within 1 month prior to Screening\n13. History of alcohol abuse or alcohol use disorder or other drug abuse within 12 months prior to screening.","locations":[{"facility":"Arizona Neuroscience Research, LLC","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perseverance Research Center, LLC (PRC)","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fullerton Neurology and Headache Center","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harbor-UCLA Medical Center - The Lundquist Institute (Los Angeles Biomedical Research Institute (LA BioMed))","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Regina Berkovich MD, PhD Inc","city":"West Hollywood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SFM Clinical Research, LLC","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nova Clinical Research, LLC","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MS and Neuromuscular Center of Excellence","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Associates","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aqualane Clinical Research","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida Department of Neurology - 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This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, multicenter study to measure the how well it works and safety of orelabrutinib compared with dummy treatment (placebo) in patients with non-active Secondary Progress MS.","whoItsFor":["Ages 18 Years to 60 Years","Participant must have a previous diagnosis of RRMS in accordance with 2024 McDonald criteria","Participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013","Absence of clinical relapses for at least 24 months"],"whoShouldSkip":["The patient has been diagnosed with primary progressive MS (PPMS) according to 2024 McDonald diagnostic criteria","Immunologic disorder other than MS or any other conditions requiring corticosteroid therapy","History or current diagnosis of other neurological disorders that may mimic MS","History or current diagnosis of progressive multifocal leukoencephalopathy","Active, clinically significant viral, bacterial, or fungal infection","History of any other significant active medical condition","History of suicidal behavior within 6 months prior to Screening"],"whatHappens":"If you join, the listed intervention(s) are Orelabrutinib, or Placebo. The registry lists allocation as randomized. Orelabrutinib is a CNS-penetrable BTK inhibitor.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 990 people at 90 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.975Z"},{"nctId":"NCT07300241","title":"Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","officialTitle":"An Open-Label, First-in-Human, Phase 1/2 Dose Escalation and Expansion Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Neomorph, Inc","sponsorClass":"INDUSTRY","summary":"The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a monotherapy.","conditions":["Clear Cell Renal Cell Carcinoma","Renal Cell Carcinoma","RCC","Clear Cell Renal Cell Carcinoma Metastatic","ccRCC","VHL-Associated Clear Cell Renal Cell Carcinoma","VHL-Associated Renal Cell Carcinoma","Kidney Cancer Metastatic","Kidney Cancers"],"keywords":["ccRCC","Renal Cell Carcinoma","Clear Cell Renal Cell Carcinoma","VHL","Kidney Cancer"],"interventions":[{"type":"DRUG","name":"NEO-811"}],"enrollment":30,"startDate":"2025-12-19","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC).\n* Subjects must have progressed on or refused standard therapies.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.\n* Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks.\n* Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study.\n* Measurable disease as defined by RECIST v1.1.\n* Adequate hematologic, hepatic, and renal function defined as:\n\n  * Hemoglobin ≥10 g/dL,\n  * Absolute neutrophil count ≥1000 cells/µL,\n  * Platelet count ≥100,000/µL,\n  * AST and ALT ≤2.5 × ULN, or AST and ALT ≤5 × ULN for subjects with liver metastases,\n  * Total bilirubin ≤1.5 × ULN,\n  * Estimated glomerular filtration rate (eGFR) ≥60 mL/min.\n* Subject can swallow oral medications and does not have a condition that could impair the oral bioavailability of the study drug.\n* Other inclusion criteria per protocol.\n\nExclusion Criteria:\n\n* Non-clear cell predominant RCC histologic subtypes.\n* Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol.\n* Prior or concurrent malignancies with exceptions per protocol.\n* History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection.\n* Other exclusion criteria per protocol.","locations":[{"facility":"NEO-811 Los Angeles Site","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEO-811 San Diego Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEO-811 Connecticut Site","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEO-811 Florida Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEO-811 Chicago Site","city":"Zion","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEO-811 Grand Rapids Site","city":"Grand Rapids","state":"Michigan","country":"United 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agent."],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","san-diego-california","new-haven-connecticut","miami-florida","zion-illinois","grand-rapids-michigan","st-louis-missouri","omaha-nebraska","lake-success-new-york","new-york-new-york","cincinnati-ohio","cleveland-ohio","myrtle-beach-south-carolina","dallas-texas","houston-texas","fairfax-virginia"],"enrichment":{"headline":"Phase 1: testing NEO-811 for Clear Cell Renal Cell Carcinoma","inPlainEnglish":"The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma. The study will test NEO-811 initially as a this drug alone.","whoItsFor":["Ages 18 Years to any","Subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma (ccRCC)","Subjects must have progressed on or refused standard therapies","Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1","Estimated life expectancy, in the judgment of the Investigator, of at least 12 weeks","Formalin-fixed paraffin-embedded (FFPE) tumor tissue, newly obtained or archival, is mandatory for enrollment to the study","Measurable disease as defined by RECIST v1.1","Adequate hematologic, hepatic, and renal function defined as:"],"whoShouldSkip":["Non-clear cell predominant RCC histologic subtypes","Leptomeningeal disease or symptomatic active CNS metastases with exceptions for asymptomatic treated CNS metastases per protocol","Prior or concurrent malignancies with exceptions per protocol","History of hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV infection"],"whatHappens":"If you join, the listed intervention(s) are NEO-811. The registry lists allocation as na. The NEO-811-101 study is an open-label, first-in-human, Phase 1/2 dose escalation and expansion study testing NEO-811, an ARNT molecular glue degrader, in subjects with locally advanced or metastatic non-resectable clear cell renal cell carcinoma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.916Z"},{"nctId":"NCT07300332","title":"Exercise Training and Vitamin D Metabolism","officialTitle":"The Impact of Hybrid-type High-intensity Interval Training on Vitamin D Metabolism in Adults With Overweight/Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Thessaly","sponsorClass":"OTHER","summary":"The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (BMI). The \"entrapment\" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism. Exercise training has been proposed as a promising strategy to increase mobilization of Vitamin D from adipose tissue, given its well described role in stimulating lipolysis. Indeed, a recent study revealed that participation in moderate-intensity cardiovascular type exercise over winter can mitigate the decline in 25-hydroxyvitamin D \\[25(OH)D\\] in adults with overweight/obesity, independent of weight loss. The aim of this study is to investigate the impact of hybrid-type high-intensity interval training over winter on vitamin D metabolism, in adults with overweight/obesity.","conditions":["Obesity & Overweight","Vitamin D"],"keywords":["overweight","obesity","vitamin D","25-hydroxyvitamin D","high-intensity interval training"],"interventions":[{"type":"OTHER","name":"Exercise training"},{"type":"OTHER","name":"Control"}],"enrollment":30,"startDate":"2025-11-01","completionDate":"2026-01-31","sex":"ALL","minAge":"35 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* BMI = 25-35 kg/m2\n* Absence of musculoskeletal injuries\n* Absence of chronic health-related complications\n* Non-smokers\n\nExclusion Criteria:\n\n* Consumption of Vitamin D supplements\n* Consumption of anti-inflammatory drugs, statins and/or steroids","locations":[{"facility":"Department of Physical Education and Sport Science, University of Thessaly","city":"Trikala","state":"Karyes","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dimitrios Draganidis, PhD","phone":"+302431047078","email":"ddraganidis@uth.gr"},{"name":"Ioannis G Fatouros, PhD","phone":"2431047047","email":"ifatouros@uth.gr"}],"primaryOutcomes":["Change in 25-hydroxyvitamin D concentration","Change in plasma Vitamin D binding protein concentration","Change in calcium concentration","Change in albumin concentration","Change in aspartate aminotransferase (SGOT) concentration","Change in alanine aminotransferase (SGPT) concentration","Change in gamma-glutamyl transferase (γ-GT) concentration"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["trikala-greece"],"enrichment":{"headline":"Not a traditional drug phase: Exercise training for Obesity & Overweight","inPlainEnglish":"The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (body-mass index (BMI)). The \"entrapment\" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism.","whoItsFor":["Ages 35 Years to 50 Years","Absence of musculoskeletal injuries","Absence of chronic health-related complications"],"whoShouldSkip":["Consumption of Vitamin D supplements","Consumption of anti-inflammatory drugs, statins and/or steroids"],"whatHappens":"If you join, the listed intervention(s) are Exercise training, or Control. The registry lists allocation as randomized. The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (body-mass index (BMI)).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Trikala. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.838Z"},{"nctId":"NCT07301268","title":"GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","officialTitle":"MC230719 Window of Opportunity Study of GI-102 in Patients With Recurrent High-Grade Glioma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.","conditions":["Glioblastoma, IDH-Wildtype","Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","Recurrent Gliosarcoma","Resectable Astrocytoma","Resectable Glioblastoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"PROCEDURE","name":"Surgical Procedure"}],"enrollment":36,"startDate":"2026-08-03","completionDate":"2029-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g/dL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500/mm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000/mm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml/min (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and/or blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\< 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose \\< 4 mg/day at time of registration\n  * Received chemotherapy \\< 30 days prior to registration\n  * Received a live vaccine \\< 30 days prior to registration\n\n    * NOTE: No washout is needed for prior immunotherapy\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\< 28 days prior to registration\n  * Radiation therapy \\< 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness/social situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue/solid organ transplant","locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Change in pharmacodynamic markers of interest in tumor tissue"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":["pembrolizumab"],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Phase 2: testing Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102 for Glioblastoma, IDH-Wildtype","inPlainEnglish":"This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults.","whoItsFor":["Ages 18 Years to any","Disease characteristics","Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma","Candidates for surgical resection","Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0","Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)","Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60","NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug"],"whoShouldSkip":["Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:","Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception","Received bevacizumab (AVASTIN) \\< 30 days prior to registration","NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study","Increasing dexamethasone dose prior to registration","NOTE: Patients currently on dexamethasone must be on dose \\< 4 mg/day at time of registration","Received chemotherapy \\< 30 days prior to registration"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bispecific CD80-lgG4Fc-IL-2v Fusion Protein GI-102, or Computed Tomography. The registry lists allocation as randomized. This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 36 people at Rochester. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.484Z"},{"nctId":"NCT07302360","title":"A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis","officialTitle":"Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Xian-Janssen Pharmaceutical Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \\[part of large intestine\\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.","conditions":["Colitis, Ulcerative"],"keywords":[],"interventions":[],"enrollment":200,"startDate":"2025-12-11","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\\>=) 2; c) Mayo rectal bleeding subscore (RBS) \\>= 1 at baseline\n* Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert\n* Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment\n* Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy\n* Contraindicated to guselkumab per the label\n* Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab\n* Participants who will be receiving guselkumab therapy combined with a second advanced therapy\n* Participants with a history of colectomy and/or pouch","locations":[{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhou No 2 Peoples Hospital","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital Sun Yat-Sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Sixth Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhejiang University","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital Zhejiang University School of Medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Hospital of Southern Medical University","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Hebei Medical University","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants Achieving Clinical Response at Week 12"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["beijing-china","changzhou-china","guangzhou-china","hangzhou-china","nanjing-china","shenzhen-china","shijiazhuang-china","tianjin-china"],"enrichment":{"headline":"A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis","inPlainEnglish":"This study wants to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \\[part of large intestine\\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.","whoItsFor":["Ages 18 Years to any","Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\\>=) 2; c) Mayo rectal bleeding subscore (RBS) \\>= 1 at baseline","Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert"],"whoShouldSkip":["Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy","Contraindicated to guselkumab per the label","Participants who will be receiving guselkumab therapy combined with a second advanced therapy","Participants with a history of colectomy and/or pouch"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 11 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.209Z"},{"nctId":"NCT07303582","title":"Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities","officialTitle":"Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"Oxford University Hospitals NHS Trust","sponsorClass":"OTHER","summary":"Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living. Current treatment options are limited, and many people experience only partial reduction in spasticity and frequent repeated treatments are needed.\n\nCryoneurolysis is a medical technique which involves the controlled freezing of the nerves. It has been approved in the UK for the treatment of pain in the context of spasticity through the targeting of nerves which control problematic muscles. Oxford University Hospitals NHS Foundation Trust has been offering this treatment routinely since January 2024. This pilot study aims to improve the understanding of the potential effectiveness of this treatment and its potential side effects when compared with a more commonly used treatment (Botulinum Toxin).\n\nParticipants will be randomly allocated to receive usual care with Botulinum Toxin (control group) or usual care with Cryoneurolysis (intervention group). The investigators will assess pain, goal attainment, side effects, spasticity, disability and independence in daily activities, and movement of the arm and leg. Assessments will be at baseline and then 6-, 12-, 18-, and 24-weeks following treatment. Participants who are randomised to the control group will have the opportunity to receive cryoneurolysis treatment after the 12 week follow up assessment.\n\nThe results of this study will help to guide future studies to examine the effectiveness of this treatment.","conditions":["Centreal Neurological Condition","Acquired Brain Injury (Including Stroke)","Multiple Sclerosis","Spinal Cord Injury"],"keywords":["Cryoneurolysis","Spasticity","Pain","Acquired Brain Injury","Stroke","Multiple Sclerosis","Spinal Cord Injury","Central Neurological Condition","Botulinum Toxin (botox)","Iovera","Chemodenervation","BoNT-A","Cryoneurotomy","Cryoneurectomy","Cryoanalgesia"],"interventions":[{"type":"PROCEDURE","name":"Cryoneurolysis"},{"type":"PROCEDURE","name":"Botulinum toxin"}],"enrollment":50,"startDate":"2025-12-02","completionDate":"2027-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice.\n* Male or Female, aged 18 years or above.\n* Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury.\n* Clinical indication for Botulinum Toxin and Cryoneurolysis treatment, including pain associated with spasticity and with a clinically meaningful response to diagnostic nerve block to specific nerves or nerve branches that can be treated with cryoneurolysis.\n* At least one rehabilitation goal related to management of pain resulting from spasticity.\n\nExclusion Criteria:\n\n* Participant has received Botulinum toxin or cryoneurolysis within the last 90 days.\n* Raynaud's syndrome.\n* Cryoglobulinaemia.\n* Cold urticaria.\n* Bleeding disorders.\n* Localised infection at intended treatment site.\n* Planned oral antispasmodic medication dose changes.\n* Pregnancy, breastfeeding, or planning pregnancy in the trial period.\n* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Participants who are currently enrolled in another trial may be excluded if it is deemed (in the investigator's opinion) that participation could influence the results for either study.","locations":[{"facility":"Oxford Centre for Enablement (OUH NHS-FT)","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anton Pick, MBChB","phone":"(+44) 01865 737306","email":"anton.pick@ouh.nhs.uk"},{"name":"Barbara Robinson, MSc","phone":"","email":"barbara.robinson@ndcn.ox.ac.uk"}],"primaryOutcomes":["Goal Attainment Scale"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als","stroke"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Phase 4: Cryoneurolysis for Centreal Neurological Condition","inPlainEnglish":"Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living.","whoItsFor":["Ages 18 Years to any","Male or Female, aged 18 years or above","Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury","Clinical indication for Botulinum Toxin and Cryoneurolysis treatment, including pain associated with spasticity and with a clinically meaningful response to diagnostic nerve block to specific nerves or nerve branches that can be treated with cryoneurolysis","At least one rehabilitation goal related to management of pain resulting from spasticity"],"whoShouldSkip":["Participant has received Botulinum toxin or cryoneurolysis within the last 90 days","Raynaud's syndrome","Bleeding disorders","Localised infection at intended treatment site","Planned oral antispasmodic medication dose changes","Pregnancy, breastfeeding, or planning pregnancy in the trial period","Scheduled elective surgery or other procedures requiring general anaesthesia during the trial"],"whatHappens":"If you join, the listed intervention(s) are Cryoneurolysis, or Botulinum toxin. The registry lists allocation as randomized. Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 50 people at Oxford. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.974Z"},{"nctId":"NCT07309445","title":"A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) in the United States","officialTitle":"A Multicenter, Prospective, Longitudinal Study to Assess Real-World Use and Outcomes After the Launch of TAR-200 for NMIBC in the US","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).","conditions":["Non-Muscle Invasive Bladder Neoplasms"],"keywords":[],"interventions":[],"enrollment":150,"startDate":"2026-06-12","completionDate":"2029-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy\n* Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1\n* Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice\n* Must provide informed consent as described in the protocol\n\nExclusion criteria:\n\n* Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment\n* Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1\n* Previously received TAR-200 intravesically as part of a clinical trial(s)\n* Previously received greater than (\\>) 2 doses/cycles of TAR-200 in the real-world setting\n* Currently participating in an interventional bladder cancer clinical trial","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic 1","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Urology","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"USC Norris Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Clinical Research","city":"Lakewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Urology Partners","city":"Wimauma","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associated Urological Specialists","city":"Chicago Ridge","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Melvin and Bren Simon Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frederick Health","city":"Frederick","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Institute of Urology","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specialty Clinical Research of St Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Med Univ","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Specialists of the Carolinas PLLC Charlotte","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MidLantic Urology - Haverford Road - Bryn Mawr","city":"Bryn Mawr","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Low Country Urology Clinics","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Specialists of South Dakota","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPNT Research Institute","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington School of Medicine","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spokane Urology","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"},{"name":"Eliza M. Raymundo, MD, DMCC, FPUA, FPCS","phone":"1-669-800-7705","email":""}],"primaryOutcomes":["Disease-Free Survival (DFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","little-rock-arkansas","los-angeles-california","lakewood-colorado","jacksonville-florida","wimauma-florida","chicago-ridge-illinois","indianapolis-indiana","frederick-maryland","troy-michigan","rochester-minnesota","st-louis-missouri","syracuse-new-york","charlotte-north-carolina","bryn-mawr-pennsylvania","north-charleston-south-carolina","sioux-falls-south-dakota","arlington-texas","dallas-texas","seattle-washington","spokane-washington"],"enrichment":{"headline":"A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder …","inPlainEnglish":"This study wants to assess how well TAR-200 works in real-word by measuring the time taken from the first TAR-200 insertion to worsening of cancer or until the signs and symptoms of cancer occur again (disease-free survival) in participants with non-muscle invasive bladder cancer (NMIBC; an early-stage bladder cancer that is limited to the inner lining of bladder).","whoItsFor":["Ages 18 Years to any","Has a confirmed diagnosis of NMIBC based on TURBT or cold cup biopsy","Initiated first dose of TAR-200 in a real-world setting within 6 weeks prior to baseline visit/Study visit 1","Participants with childbearing potential are required to adhere to contraceptive recommendations as specified in the approved product labeling for TAR-200. Additionally, participants should seek consultation with their physician for personalized contraceptive advice"],"whoShouldSkip":["Has any medical condition deemed by the health care practitioner (HCP) as contraindicated to receive TAR-200 treatment","Had previous treatment with TAR-200 discontinued prior to baseline visit/Study visit 1","Previously received TAR-200 intravesically as part of a clinical trial(s)","Previously received greater than (\\>) 2 doses/cycles of TAR-200 in the real-world setting","Currently participating in an treatment bladder cancer clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at 23 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.317Z"},{"nctId":"NCT07309614","title":"A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma","officialTitle":"A Multinational, Investigator-initiated, Parallel Group, Randomised, Double-blind, Placebo-controlled Phase 3b Superiority Trial Assessing the Effect of Dupilumab on Inducing Clinical Remission Outcomes in At-risk Type-2 Inflammatory Asthma (HOTHOT)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Université de Sherbrooke","sponsorClass":"OTHER","summary":"This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called \"remission\") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage. This study explores whether treating high-risk patients earlier could prevent asthma attacks and lung function decline, potentially achieving remission before permanent damage occurs. The study is looking for adults aged 18-79 with moderate asthma who have had at least one asthma attack requiring steroid pills in the past 2 years, use medium or high-dose inhaled steroids regularly, have high levels of inflammation markers in their blood and breath tests, but don't yet meet criteria for severe asthma requiring biologic therapy. Participants receive either dupilumab or placebo injections every 2 weeks for one year, alongside their regular asthma medications. They attend clinic visits every 3 months for breathing tests, questionnaires, and safety monitoring. Neither participants nor doctors know who receives the real medication until the study ends. The goal is to learn whether early treatment with dupilumab helps more people achieve complete asthma control compared to standard care alone, potentially changing how asthma is treated from \"waiting until severe\" to \"preventing severe disease.\" The study runs in Canada, the United Kingdom, and Australia, involving 150 participants","conditions":["Asthma Control"],"keywords":["Asthma","Asthma control","moderate asthma","dupilumab","remission","type-2 inflammation","blood eosinophils","feno","exacerbations","trial","RCT"],"interventions":[{"type":"DRUG","name":"Dupilumab Prefilled Syringe"},{"type":"DRUG","name":"Placebo Injection"}],"enrollment":150,"startDate":"2026-01-29","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":"79 Years","healthyVolunteers":false,"eligibilityRaw":"INCLUSION CRITERIA\n\nStudy participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Participant must be 18-\\<80 years of age at the time of signing the informed consent.\n\n   Type of participant and disease characteristics\n2. Physician diagnosis of asthma (according to GINA 2025) for ≥6 months, with documented historical airflow variability by one of the following:\n\n   * Positive reversibility test: ≥12% and 200 ml in FEV1 after SABA administration at any point prior to randomisation\n   * Airflow variability in clinic FEV1 \\>12% and 200 mL between historical clinical visits\n   * Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine (\\<16 mg/mL or \\<400mcg); or ≥10% with standardised hyperventilation, or exercise challenge test; or ≥15% with hypertonic saline or mannitol challenge\n   * Peak flow variability of \\>20% between two assessments\n3. Evidence of elevated type-2 biomarkers defined as both of:\n\n   1. peripheral BEC ≥ 0.3×109/L at screening visit\n   2. FeNO ≥ 35 ppb at screening visit\n4. At least 1 asthma attack in the last 2 years, defined as acute asthma requiring SCS for ≥ 3 days or an emergency/hospital visit requiring SCS.\n5. Treatment and evident adherence to a stable at-least medium-dose ICS (fluticasone propionate equivalent \\>250 mcg/day) for at least 3 months (including run-in period) \\[additional controllers e.g. LABA, LAMA or LTA are allowed\\]. The ICS dosage will be defined as the dosage received on a regularly basis, excluding extra reliever doses taken in the context of anti-inflammatory reliever (AIR) therapy from the calculation. AIR is allowed in the context of the study. Thus, the high-dose ICS trial population (fluticasone propionate equivalent \\>500 mcg/day)\\* will represent patients who are not meeting the exacerbation criteria for biological reimbursement.\n\n   \\*As per section 6.2, we will cap recruitment to 60% of target population on medium-dose ICS, 40% on high-dose ICS, with randomisation also stratified by these categories.\n6. Presence of one (or more) of the following additional risk factors for asthma attacks32 at screening or baseline: (i) uncontrolled asthma symptoms indicated by ACQ5 score of ≥ 1.5; (ii) impaired lung function indicated by post-bronchodilator FEV1 of ≤ 80% predicted; (iii) high-dose maintenance ICS therapy (iv) severe asthma attack in past 1-\\<12 months.\n\n   Sex, contraceptive/barrier method and pregnancy testing requirements\n7. Female participants\n\n   a. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   i. Is a woman of nonchildbearing potential (WONCBP) as defined in the Study Manual.\n\n   OR ii. Is a WOCBP and agrees to use a contraceptive method that is highly effective, with a failure rate of \\<1%, during the intervention period (to be effective before starting the intervention) and for at least 12 weeks after the last dose of study intervention.\n\n   b. A WOCBP must have a negative highly sensitive serum pregnancy test at V1 (screening visit) and urine or serum pregnancy test (as required by local regulations) on Day 1 before the first dose of study intervention, c. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n\n   d. Additional requirements for pregnancy testing during and after study intervention are imposed.\n\n   e. The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female participant with an early undetected pregnancy.\n\n   Informed consent\n8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\n4.2 EXCLUSION CRITERIA\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical conditions\n\n1. Use of SCS \\< 1 months prior to screening or on maintenance SCS.\n2. Current tobacco smoker or recently stopped smoker (\\<6 months)\n3. Ex-smoker with greater than 10 pack-years AND post bronchodilator FEV1/FVC ratio below the lower limit of normal according to GLI race-neutral standards. 69\n4. Documented nonadherence to ICS, defined as dispensing of less than 75% of the prescribed ICS dose over the past 12 months (or annualised if less than 12 months), based on pharmacy refill records checked at screening.\n5. Presence of significant and uncorrectable inhaler technique deficiencies, as assessed by the research team during inhaler technique evaluation at screening.\n6. Contra-indication to study drug\n7. Immunological disease, condition or medication that may affect the inflammatory response according to Investigator.\n8. History of other significant lung disease e.g. lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, clinically significant bronchiectasis, chronic obstructive lung disease, or Churg-Strauss.\n9. Severe concomitant illness (including known or suspected immunodeficiency) that, in the Investigator's judgement will adversely affect the participant's participation in the study.\n10. Active malignancy or history of malignancy within 5 years (except for basal cell carcinoma of the skin or fully resected Cervical Intraepithelial Neoplasia/dysplasia).\n11. Exposure to monoclonal antibody therapy for asthma or another investigational medicinal product within 5 half-lives of the drug.\n12. Eligibility to Dupilumab based on licensed and reimbursed indications in the participant's jurisdiction (e.g. nasal polyposis, atopic dermatitis, eosinophilic esophagitis, prurigo nodularis, etc.)\n13. Treatment with live (attenuated) vaccine in the past 4 weeks.\n14. Prohibited medication\n15. Current helminth infection","locations":[{"facility":"Sir Charles Gairdner Hospital","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut universitaire de cardiologie et de pneumologie de Québec","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIUSSS de l'Estrie- CHUS","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital","city":"Oxford","state":"Oxfordshire","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Win ratio based on remission criteria"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["dupilumab"],"locationSlugs":["nedlands-australia","montreal-canada","qu-bec-canada","sherbrooke-canada","oxford-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Dupilumab Prefilled Syringe for Asthma Control","inPlainEnglish":"This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called \"remission\") when given earlier in their disease, before asthma becomes severe. Currently, most people with asthma only receive advanced treatments like biologics after their condition has worsened significantly and caused lung damage.","whoItsFor":["Ages 18 Years to 79 Years","Study participants are eligible to be included in the study only if all of the following criteria apply:","Type of participant and disease characteristics","Physician diagnosis of asthma (according to GINA 2025) for ≥6 months, with documented historical airflow variability by one of the following:","Positive reversibility test: ≥12% and 200 ml in FEV1 after SABA administration at any point prior to randomisation","Airflow variability in clinic FEV1 \\>12% and 200 mL between historical clinical visits","Positive bronchial challenge test: fall in FEV1 of ≥20% with standard doses of methacholine (\\<16 mg/mL or \\<400mcg); or ≥10% with standardised hyperventilation, or exercise challenge test; or ≥15% with hypertonic saline or mannitol challenge","Peak flow variability of \\>20% between two assessments"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Use of SCS \\< 1 months prior to screening or on maintenance SCS","Current tobacco smoker or recently stopped smoker (\\<6 months)","Ex-smoker with greater than 10 pack-years AND post bronchodilator FEV1/FVC ratio below the lower limit of normal according to GLI race-neutral standards. 69","Documented nonadherence to ICS, defined as dispensing of less than 75% of the prescribed ICS dose over the past 12 months (or annualised if less than 12 months), based on pharmacy refill records checked at screening","Presence of significant and uncorrectable inhaler technique deficiencies, as assessed by the research team during inhaler technique evaluation at screening","Contra-indication to study drug"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab Prefilled Syringe, or Placebo Injection. The registry lists allocation as randomized. This study tests whether an asthma medication called dupilumab can help people achieve complete asthma control (called \"remission\") when given earlier in their disease, before asthma becomes severe.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 150 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.342Z"},{"nctId":"NCT07310095","title":"A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)","officialTitle":"Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Xian-Janssen Pharmaceutical Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.","conditions":["Crohn Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Guselkumab (GUS)"}],"enrollment":78,"startDate":"2025-12-30","completionDate":"2027-09-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a confirmed diagnosis of Crohn's disease (CD)\n* Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220\n* Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks\n* Initially responded to UST induction therapy and then lose response to UST\n* During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic\n\nExclusion Criteria:\n\n* Received UST dose optimization or multiple intravenous therapy in maintenance phase\n* Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months\n* Is currently enrolled in an interventional clinical study\n* Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome\n* Have a current or be suspected to have an abscess","locations":[{"facility":"The First Affiliated Hospital Sun Yat sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Sixth Affiliated Hospital Sun Yat sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital Zhejiang University School of Medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants Achieving Clinical Remission At Week 48"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["guangzhou-china","hangzhou-china","hefei-china","shanghai-china"],"enrichment":{"headline":"Phase 4: testing Guselkumab (GUS) for Crohn Disease","inPlainEnglish":"This study wants to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.","whoItsFor":["Ages 18 Years to any","Has a confirmed diagnosis of Crohn's disease (CD)","Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220","Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks","Initially responded to UST induction therapy and then lose response to UST","During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic"],"whoShouldSkip":["Received UST dose optimization or multiple intravenous therapy in maintenance phase","Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months","Is currently enrolled in an treatment clinical study","Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome","Have a current or be suspected to have an abscess"],"whatHappens":"If you join, the listed intervention(s) are Guselkumab (GUS). The registry lists allocation as na. This study wants to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 78 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.896Z"},{"nctId":"NCT07310433","title":"Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer","officialTitle":"Dapagliflozin Combined With Next-generation Hormonal Agent (NHA) Versus Single NHA in Participants With Metastatic Castrate-resistant Prostate Cancer: a Phase 2, Multicenter, Open-label, Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Yung NA","sponsorClass":"OTHER","summary":"Dapagliflozin is a well-established medication being marketed and used for treatment Type 2 diabetes mellitus (T2DM). In retrospective cohort studies done by our team, we found that metastatic prostate cancer patients who received Dapagliflozin together with standard anti-cancer treatment, androgen deprivation therapy (ADT) combined with novel hormonal agent (NHA), had better tumor control than those having ADT and NHA.","conditions":["Prostate Cancer","Metastatic Prostate Cancer"],"keywords":["prostate cancer","sglt2"],"interventions":[{"type":"DRUG","name":"Dapagliflozin (10mg Tab)"},{"type":"DRUG","name":"standard medical care (ADT + NHA)"}],"enrollment":68,"startDate":"2026-05-01","completionDate":"2029-04-30","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age of 18 years and above\n* Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine/ small cell histology;\n* PCa progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening: two consecutive rising PSA levels, radiographic soft tissue or bone progression;\n* Current evidence of metastatic disease by radiological scan;\n* Decided to receive any of the NHA (including Abiraterone Acetate, Enzalutamide, Apalutamide or Darolutamide) under standard of care setting, or started NHA for no more than 28 days at the time of treatment period start;\n* Ongoing androgen deprivation with serum testosterone \\<50 ng/dL (\\<1.7 nM);\n* Naïve of taxane-based chemotherapy regimens;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1;\n* Normal hematologic and organ function as defined below: (a) leukocytes ≥ 3,000/mcL; (b) absolute neutrophil count ≥ 1,500/mcL; (c) platelets ≥ 100,000/mcL; (d) total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN); (e) AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN; (f) estimated glomerular filtration rate eGFR ≥ 30 mL/min/1.73m2;\n* Ability to understand and willingness to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Current or previous treatment with SGLT2 inhibitors or thiazolidinedione;\n* Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c \\> 10%, unless approved by endocrinologist);\n* Presence of malignancies other than prostate cancer within two years prior to study enrollment;\n* Disease progressed during or after treatment with one NHA;\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin;\n* Clinically significant abnormal serum potassium or sodium level;\n* Presence of uncontrolled comorbidities including but not limited to ongoing or active infection (e.g., HIV, HBV, HCV and tuberculosis), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, peripheral arterial disease, ketoacidosis, severe kidney disease, symptomatic hypotension, and chronic/frequent urinary tract infections or yeast infections;\n* Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;\n* Inability to swallow capsules/tablets\n* Any medical conditions that might deem unsafe or contraindicated for inclusion in the clinical trial, per investigator's discretion","locations":[{"facility":"Huashan Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Coordinator","phone":"852-22554852","email":"stac@hku.hk"}],"primaryOutcomes":["Radiographic Progression-Free Survival (rPFS)"],"hasResults":false,"conditionSlugs":["prostate-cancer","type-2-diabetes"],"drugSlugs":["dapagliflozin"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing Dapagliflozin (10mg Tab) for Prostate Cancer","inPlainEnglish":"Dapagliflozin is a well-established medication being marketed and used for treatment Type 2 diabetes mellitus (T2DM). In retrospective cohort studies done by our team, we found that metastatic prostate cancer patients who received Dapagliflozin together with standard anti-cancer treatment, androgen deprivation therapy (ADT) combined with novel hormonal agent (NHA), had better tumor control than those having ADT and NHA.","whoItsFor":["Ages 18 Years to any","Men only","Age of 18 years and above","Histologically or cytologically confirmed diagnosis of prostatic adenocarcinoma without neuroendocrine/ small cell histology;","PCa progression while receiving ADT (or post bilateral orchiectomy) within 6 months before screening: two consecutive rising PSA levels, radiographic soft tissue or bone progression;","Current evidence of metastatic disease by radiological scan;","Decided to receive any of the NHA (including Abiraterone Acetate, Enzalutamide, Apalutamide or Darolutamide) under standard of care setting, or started NHA for no more than 28 days at the time of treatment period start;","Ongoing androgen deprivation with serum testosterone \\<50 ng/dL (\\<1.7 nM);","Naïve of taxane-based chemotherapy regimens;"],"whoShouldSkip":["Current or previous treatment with SGLT2 inhibitors or thiazolidinedione;","Presence of type 1 diabetes mellitus, insulin-requiring diabetes mellitus or poorly controlled diabetes mellitus (i.e., HbA1c \\> 10%, unless approved by endocrinologist);","Presence of malignancies other than prostate cancer within two years prior to study enrollment;","Disease progressed during or after treatment with one NHA;","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to dapagliflozin;","Clinically significant abnormal serum potassium or sodium level;","Participation in another clinical trial with therapeutic intent within 28 days prior to enrollment;"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin (10mg Tab), or standard medical care (ADT + NHA). The registry lists allocation as randomized. Dapagliflozin is a well-established medication being marketed and used for treatment Type 2 diabetes mellitus (T2DM).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 68 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.952Z"},{"nctId":"NCT07316127","title":"Immunoadsorption in Autoimmune Long COVID","officialTitle":"A Placebo-Controlled, Double-Blind, Randomized Trial Phase I-II With Immunoadsorption in Autoimmune Long COVID","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)","sponsorClass":"OTHER","summary":"Some people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity. In some patients, this may happen because the immune system is attacking the body by mistake.\n\nThis study will test a treatment called immunoadsorption, which filters the blood to remove harmful antibodies. People with long COVID who have these antibodies will be randomly assigned to receive either the real treatment or a placebo. The main goal is to see whether fatigue improves after one month, and whether other symptoms and daily functioning improve over six months.\n\nThis research will help us find out if this treatment can benefit the group of long COVID patients with immune-related disease.","conditions":["Long COVID","Long COVID Syndrome","Long COVID-19 Syndrome","Post COVID Syndrome"],"keywords":["immunoadsorption","long COVID","post COVID","plasmapheresis"],"interventions":[{"type":"DEVICE","name":"Immunoadsorption"},{"type":"DEVICE","name":"Sham Comparator"}],"enrollment":70,"startDate":"2026-01-01","completionDate":"2027-12-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Long COVID based on the WHO-criteria\n* PEM according to the DSQ-PEM\n* BELL's functionality score 20-70%\n* Good health prior to the long COVID diagnosis (WHO performance score 0)\n\nExclusion Criteria:\n\n* Medical history of clinically significant respiratory- or cardiovascular disease\n* Prior interventional cardiac procedure within 3 months prior to randomization\n* Active immunosuppresive treatment for systemic autoimmune disorders\n* Diabetes type 1\n* Solid organ malignancy in the last 5 years\n* Active psychiatric disorder currently under treatment by a psychiatrist\n* BMI \\> 35\n* Pre-existing fatigue\n* Poor performance score prior to the long COVID diagnosis (WHO performance \\>0)\n* Pregnancy or breastfeeding","locations":[{"facility":"AUMC","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daphne Schouten, MD","phone":"+31 20 566 9111","email":"postcovidtrials@amsterdamumc.nl"}],"primaryOutcomes":["Change in fatigue measured by the Fatigue Assessment Scale (FAS)"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["amsterdam-netherlands"],"enrichment":{"headline":"Phase 2: Immunoadsorption for Long COVID","inPlainEnglish":"Some people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity. In some patients, this may happen because the immune system is attacking the body by mistake.","whoItsFor":["Ages 18 Years to 65 Years","Long COVID based on the WHO-criteria","PEM according to the DSQ-PEM","BELL's functionality score 20-70%","Good health prior to the long COVID diagnosis (WHO performance score 0)"],"whoShouldSkip":["Medical history of clinically significant respiratory- or cardiovascular disease","Prior treatment cardiac procedure within 3 months prior to randomization","Active immunosuppresive treatment for systemic autoimmune disorders","Solid organ malignancy in the last 5 years","Active psychiatric disorder currently under treatment by a psychiatrist","Pre-existing fatigue","Poor performance score prior to the long COVID diagnosis (WHO performance \\>0)"],"whatHappens":"If you join, the listed intervention(s) are Immunoadsorption, or Sham Comparator. The registry lists allocation as randomized. Some people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 70 people at Amsterdam. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.230Z"},{"nctId":"NCT07318389","title":"ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer","officialTitle":"ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.","conditions":["Dynamic Tumor Resistance","Metastatic Colorectal Cancer"],"keywords":[],"interventions":[{"type":"OTHER","name":"SOC (Standard of care)"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Cetuximab"},{"type":"DRUG","name":"Panitumumab"},{"type":"DRUG","name":"FOLFIRI"},{"type":"DRUG","name":"FOLFOX"},{"type":"DRUG","name":"Encorafenib"},{"type":"DRUG","name":"Adagrasib"},{"type":"DRUG","name":"Trifluridine/tipiracil (TAS-102)"},{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Tucatinib"},{"type":"DRUG","name":"Sotorasib"}],"enrollment":100,"startDate":"2026-04-22","completionDate":"2027-11-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Eligibility Criteria\n\n* The participant has a histologically or cytologically confirmed diagnosis of colorectal cancer.\n* Confirmation of non-MSI-H/pMMR status.\n* Tumor that is measurable as per RECIST v1.1 and biopsy able, defined as lesion/tumor that can be biopsied without undue risk.\n* Age ≥ 18 years.\n* ECOG performance status 0-2.\n* Due to the potential teratogenic effect of chemotherapy, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen (Refer to Pregnancy Assessment Policy MD Anderson Institutional\n\nPolicy # CLN1114). This includes all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n* Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n* History of hysterectomy or bilateral salpingo-oophorectomy.\n* Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n* History of bilateral tubal ligation or another surgical sterilization procedure.\n* Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for an adequate amount of time following end of treatment based on the SOC indications for the administered regimen.\n  * The participant is willing and able to sign the informed consent in compliance with protocol requirements, including mandatory biopsies.\n\nExclusion Criteria\n\n* Pregnancy.\n* Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and/or endpoint assessments will be excluded.\n* Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded.\n* Participants who have undergone treatment with both oxaliplatin and irinotecan in the metastatic setting will be excluded. Treatment with oxaliplatin in the adjuvant setting with relapse within 6 months will be counted as treatment in the metastatic setting for the purpose of this criterium.\n* For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded.\n* Concurrent participation in any other interventional trial.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Scott Kopetz, MD","phone":"713-792-2828","email":"skopetz@mdanderson.org"}],"primaryOutcomes":["safety and adverse events (AEs)"],"hasResults":false,"conditionSlugs":["colorectal-cancer"],"drugSlugs":["trastuzumab-deruxtecan","sotorasib"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Early phase 1: testing Bevacizumab for Dynamic Tumor Resistance","inPlainEnglish":"To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.","whoItsFor":["Ages 18 Years to any","Eligibility Criteria","The participant has a histologically or cytologically confirmed diagnosis of colorectal cancer","Confirmation of non-MSI-H/pMMR status","Tumor that is measurable as per RECIST v1.1 and biopsy able, defined as lesion/tumor that can be biopsied without undue risk","how well you can do daily activities (ECOG score) 0-2","Policy # CLN1114). This includes all female participants, between the onset of menses and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:","Postmenopausal (no menses in greater than or equal to 12 consecutive months)"],"whoShouldSkip":["Participants with concurrent or recent (less than 1 year before consent) malignancies that have the potential to interfere with the study safety and/or endpoint assessments will be excluded","Participants for whom there is an intent to proceed to curative therapy (i.e., resection) will be excluded","For participants who have undergone treatment for metastatic disease, participants who have not progressed (clinically or radiographically) on the most recent therapy will be excluded","Concurrent participation in any other treatment trial"],"whatHappens":"If you join, the listed intervention(s) are SOC (Standard of care), Bevacizumab, or Cetuximab. The registry lists allocation as na. To find out if certain drug/therapy combinations that are targeted to individual patients based on characteristics of their disease types may help to control the disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 100 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.362Z"},{"nctId":"NCT07318558","title":"A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)","officialTitle":"A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced Non-HRD Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/GOG-3102)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\n* Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n* Observation, which is watching to see if cancer grows or worsens\n\nThe study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.","conditions":["Ovarian Neoplasms","Ovarian Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Sacituzumab tirumotecan"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Rescue Medications"}],"enrollment":900,"startDate":"2026-02-16","completionDate":"2033-02-25","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The main inclusion criteria include but are not limited to the following:\n\n* Has diagnosis of FIGO 2014 Stage III or Stage IV, histologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma with one of the following histologies: high-grade serous, high-grade endometrioid, clear cell carcinoma, or malignant mixed Müllerian tumour with a high-grade serous component. Tumors reported as Grade 2 may be enrolled only if predominately (\\>50%) Grade 3 features are present.\n* Has completed primary debulking surgery or interval debulking surgery.\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol.\n* Has provided tumor tissue that is not previously irradiated.\n* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV\n* Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n* Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection.\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma.\n* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.\n* Has a history of severe eye disease.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening.\n* Received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria.\n* Had a live or live-attenuated vaccine within 30 days of randomization.\n* Has a known additional malignancy that is progressing or required active treatment within the past 3 years.\n* Has active infection requiring systemic therapy.\n* Has concurrent and active HBV and HCV infections.\n* Has HIV infection and a history of Kaposi's sarcoma and/or multicentric Castleman's disease.\n* Has not recovered from major surgery or has ongoing surgical complications.\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory.\n* Active or ongoing stomatitis of any grade.","locations":[{"facility":"University of Alabama - 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( Site 3402)","city":"Bangkok","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine Siriraj Hospital ( Site 3401)","city":"Bangkoknoi","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine - Khon Kaen University ( Site 3403)","city":"Muang","state":"Changwat Khon Kaen","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal United Hospital Bath NHS Foundation Trust ( Site 2808)","city":"Bath","state":"Bath And North East Somerset","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrookes Hospital ( Site 2802)","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Leicester NHS Trust ( Site 2805)","city":"Leicester","state":"Leicestershire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals ( Site 2801)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust ( Site 2804)","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","la-jolla-california","walnut-creek-california","aurora-colorado","highlands-ranch-colorado","miami-beach-florida","orlando-florida","atlanta-georgia","arlington-heights-illinois","fort-wayne-indiana","indianapolis-indiana","covington-louisiana","scarborough-maine","columbia-maryland","omaha-nebraska","reno-nevada","albany-new-york","new-york-new-york","durham-north-carolina","cincinnati-ohio","hilliard-ohio","tulsa-oklahoma","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","providence-rhode-island","germantown-tennessee","knoxville-tennessee","nashville-tennessee","fort-worth-texas","fairfax-virginia","norfolk-virginia","ciudad-autonoma-de-buenos-aires-argentina","ciudad-aut-noma-de-buenos-aires-argentina","mar-del-plata-argentina","buenos-aires-argentina","rosario-argentina","caba-argentina","la-rioja-argentina","westmead-australia","brisbane-australia","east-melbourne-australia","vienna-austria","innsbruck-austria","linz-austria","charleroi-belgium","ghent-belgium","leuven-belgium","salvador-brazil","natal-brazil","porto-alegre-brazil","lages-brazil","s-o-jos-do-rio-preto-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","chicoutimi-canada","montreal-canada","port-montt-chile","santiago-chile","vi-a-del-mar-chile","medell-n-colombia","bogot-colombia","valledupar-colombia","bogota-colombia","pereira-colombia","brno-czechia","ostrava-poruba-czechia","hradec-kr-lov-czechia","prague-czechia","herlev-denmark","aalborg-denmark","aarhus-denmark","odense-denmark","oulu-finland","kuopio-finland","tampere-finland","turku-finland","lyon-france","strasbourg-france","marseille-france","pl-rin-france","brest-france","toulouse-france","limoges-france","tours-france","lille-france","clermont-ferrand-france","kassel-germany","jena-germany","athens-greece","thessaloniki-greece","kecskem-t-hungary","gy-r-hungary","budapest-hungary","debrecen-hungary","cork-ireland","dublin-ireland","haifa-israel","holon-israel","ramat-gan-israel","brescia-italy","lecco-italy","milan-italy","padova-italy","roma-italy","torino-italy","nagoya-japan","kurume-japan","ta-japan","sapporo-japan","akashi-japan","shiwa-gun-japan","hidaka-japan","sunto-gun-japan","koto-japan","shinjyuku-japan","fukuoka-japan","kagoshima-japan","niigata-japan","okayama-japan","osaka-japan","stavanger-norway","kristiansand-norway","oslo-norway","lima-peru","poznan-poland","siedlce-poland","bialystok-poland","szczecin-poland","seodaemun-gu-south-korea","daegu-south-korea","seoul-south-korea","girona-spain","a-coru-a-spain","madrid-spain","valencia-spain","barcelona-spain","c-rdoba-spain","stockholm-sweden","bern-switzerland","bellinzona-switzerland","chur-switzerland","geneva-switzerland","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkok-thailand","bangkoknoi-thailand","muang-thailand","bath-united-kingdom","cambridge-united-kingdom","leicester-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Sacituzumab tirumotecan for Ovarian Neoplasms","inPlainEnglish":"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible.","whoItsFor":["Ages 18 Years to any","Women only","The main include but are not limited to the following:","Has completed primary debulking surgery or interval debulking surgery","Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol","Has provided tumor tissue that is not previously irradiated","Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if diagnosed with HIV","Has undetectable hepatitis B virus (HBV) viral load and received HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive","Has undetectable hepatitis C virus (HCV) viral load if has a history of HCV infection"],"whoShouldSkip":["include but are not limited to the following:","Has nonepithelial cancers, low-grade serous tumors, low-grade endometrioid tumors, borderline tumors mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor, and undifferentiated carcinoma","Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis","Has a history of severe eye disease","Has active inflammatory bowel disease requiring immunosuppressive medication or a previous history of inflammatory bowel disease","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease","Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD), which required steroids, has current pneumonitis/ILD, or has suspected ILD, or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening"],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Bevacizumab, or Rescue Medications. The registry lists allocation as randomized. Researchers are looking for new ways to treat ovarian cancer (OC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 900 people at 177 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.158Z"},{"nctId":"NCT07318688","title":"Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-associated Pain","officialTitle":"A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of HMI-115 in Women With Moderate to Severe Endometriosis-Associated Pain Over a 24-Week Treatment Period and a 28-Week Extension","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Hope Medicine (Nanjing) Co., Ltd","sponsorClass":"INDUSTRY","summary":"A phase 3 study to evaluate the efficacy and safety of HMI-115 in women with moderate to severe endometriosis-associated pain over a 24-week treatment period and a 28-week extension","conditions":["Endometriosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"HMI-115"},{"type":"DRUG","name":"Placebo"}],"enrollment":540,"startDate":"2026-01-29","completionDate":"2028-03-01","sex":"FEMALE","minAge":"18 Years","maxAge":"49 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Premenopausal female subjects, between 18 and 49 years of age, inclusive.\n* 2\\. Has a surgical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening.\n* 3\\. Has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at screening with a score of at least 2 for DYS and at least 2 for NMPP.\n* 4\\. Subject has reported \"moderate\" or \"severe\" for her endometriosis-associated DYS AND NMPP before randomization.\n* 5\\. Subject has at least two consecutive regular menstrual cycle (i.e. 21 to 35 days in duration) prior to randomization.\n* 6\\. Subject agrees to use required (nonhormonal) birth control methods during the entire length of participation in the study and agrees to avoid pregnancy from signing the informed consent until 12 weeks after the last dose.\n* 7\\. Subject agrees to use only those rescue analgesic medications permitted by the protocol during the Screening, Treatment and Posttreatment follow-up Periods for her endometriosis-associated pain.\n* 8\\. Criteria for Extension Treatment Period：Subject who completes treatment of the placebo-controlled double-blind treatment period and assessments at Week 24.\n\nExclusion Criteria:\n\n* 1\\. Subject who is pregnant or breastfeeding or is planning a pregnancy during the study period or is less than 6 months post-partum or 3 months post-abortion at the time of entry into the Screening Period or pregnancy before randomization.\n* 2\\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening.\n* 3\\. Subject has chronic pelvic pain that is not caused by endometriosis (e.g., interstitial cystitis, irritable bowel syndrome) or has any other chronic pain syndrome (e.g., fibromyalgia, chronic back pain, myofascial pain syndrome, chronic headaches) that requires chronic analgesic or other chronic therapy, which would interfere with the assessment of endometriosis-associated pain.\n* 4\\. Subject with a current history of undiagnosed abnormal genital bleeding.\n* 5\\. Subject with history of hysterectomy and/or bilateral oophorectomy.\n* 6\\. Subject has had surgery for endometriosis within 6 weeks prior to entry into the Screening Period.\n* 7\\. Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti-inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding.\n* 8\\. Subject with known hypersensitivity to any of the IMP ingredients.\n* 9\\. Subject has an estimated glomerular filtration rate (eGFR) of \\< 60mL/min/1.73 m2 at Screening Period.\n* 10\\. Subject is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to the start of Screening Period or 5 half-lives, whichever is longer.\n* 11\\. Subject who has been exposed to HMI-115 treatment.\n* 12\\. Subject has used medications such as hormones, analgesics, medications associated with bone loss, products that affect PRL levels, etc. within specific time window before Screening.\n* 13\\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including:\n\n  1. Alanine transaminase (ALT/SGPT), or aspartate aminotransferase (AST/SGOT) ≥200% of the upper limit of normal, or total bilirubin (unless known diagnosis of Gilbert's syndrome) ≥ 150% of the upper limit of normal range.\n  2. Hemoglobin \\< 100 g/L, Neutrophil count \\< 1.5×109/ L, Platelet count \\< 100×109/ L.\n* 14\\. Subject has clinically significantly abnormal laboratory tests at Screening Period, including: Neutrophil count \\< 1.5×109/ L, Platelet count \\< 100×109/ L.\n* 15\\. Subject has clinically significant abnormal ECG, or ECG with QTcF \\> 450 msec at Screening Period.\n* 16\\. Subject has a history or current has malignancy except for treated basal cell carcinoma and cutaneous squamous cell carcinoma of the skin.\n* 17\\. Subject is using any systemic corticosteroids for over 14 days within 3 months prior to Screening or is likely to require treatment with systemic corticosteroids during the study.\n* 18\\. Subject has any of the following conditions within the last 6 months before Screening:\n\n  1. Myocardial infarction, stroke, unstable angina or transient ischemic attack.\n  2. Classified as being in New York Heart Association Class III or IV.\n* 19\\. Subjects with body weight greater than 300 pounds or 136 kilograms.\n* 20\\. Any other conditions in the Investigator's opinion that prevent the subject from participating.\n* 21\\. Criteria for Extension Treatment Period： Subjects entering the follow-up period after treatment: subjects with a BMD decrease of ≥ 8.0% or Z-value ≤ -2.0 in any part of the lumbar spine, femoral neck, or total hip compared to baseline.","locations":[{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Women and children's healthcare hospital","city":"Nanning","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Second Affiliated Hospital of Soochow University","city":"Suzhu","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The International Peace Maternity and Child Health Hospital of the China Welfare Institute","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xu Yeqing","phone":"86-18717858198","email":"yeqing.xu@hopemedinc.com"}],"primaryOutcomes":["Change from Baseline (CFB) in dysmenorrhea (DYS) measured by Numeric Rating Scale (NRS) at Week 12","CFB in non-menstrual pelvic pain (NMPP) measured by NRS at Week 12"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["beijing-china","nanning-china","suzhu-china","shanghai-china","tianjin-china"],"enrichment":{"headline":"Phase 3: testing HMI-115 for Endometriosis","inPlainEnglish":"A phase 3 study to measure the how well it works and safety of HMI-115 in women with moderate to severe endometriosis-associated pain over a 24-week treatment period and a 28-week extension","whoItsFor":["Ages 18 Years to 49 Years","Women only","1\\. Premenopausal female subjects, between 18 and 49 years of age, inclusive","2\\. Has a surgical diagnosis of endometriosis (laparoscopy or laparotomy) as documented by medical records within 10 years before screening","3\\. Has a Composite Pelvic Signs and Symptoms Score total score of ≥ 6 at screening with a score of at least 2 for DYS and at least 2 for NMPP","4\\. Subject has reported \"moderate\" or \"severe\" for her endometriosis-associated DYS AND NMPP before randomization","5\\. Subject has at least two consecutive regular menstrual cycle (i.e. 21 to 35 days in duration) prior to randomization","7\\. Subject agrees to use only those rescue analgesic medications permitted by the protocol during the Screening, Treatment and Posttreatment follow-up Periods for her endometriosis-associated pain","8\\. Criteria for Extension Treatment Period：Subject who completes treatment of the compared with a dummy treatment neither you nor the study doctors know who gets the real treatment treatment period and assessments at Week 24"],"whoShouldSkip":["1\\. Subject who is pregnant or breastfeeding or is planning a pregnancy during the study period or is less than 6 months post-partum or 3 months post-abortion at the time of entry into the Screening Period or pregnancy before randomization","2\\. Subject has an intra-uterine device (IUD). Subject is eligible if she removes the IUD 1 month before screening","4\\. Subject with a current history of undiagnosed abnormal genital bleeding","5\\. Subject with history of hysterectomy and/or bilateral oophorectomy","6\\. Subject has had surgery for endometriosis within 6 weeks prior to entry into the Screening Period","7\\. Subject has previous history of a severe, life-threatening or other significant sensitivity to any opioids or non-steroidal anti-inflammatory drugs (NSAIDS) or any contraindication to their use such as gastrointestinal ulcer or bleeding","8\\. Subject with known hypersensitivity to any of the IMP ingredients"],"whatHappens":"If you join, the listed intervention(s) are HMI-115, or Placebo. The registry lists allocation as randomized. A phase 3 study to measure the how well it works and safety of HMI-115 in women with moderate to severe endometriosis-associated pain over a 24-week treatment period and a 28-week extension","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 540 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.117Z"},{"nctId":"NCT07318805","title":"A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors","officialTitle":"A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication.\n\nThis study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC).\n\nAll participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles.\n\nDepending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.","conditions":["Advanced Breast Cancer","Metastatic Breast Cancer (HR+/ HER2-)","Colorectal Cancer","Metastatic Colorectal Adenocarcinoma","Triple Negative Breast Cancer"],"keywords":["Carcinoma, Breast","Estrogen Receptor Positive Breast Cancer","HER2- Breast Cancer","Triple Negative Breast Cancer","Colon Cancer"],"interventions":[{"type":"DRUG","name":"PF-08032562"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Cetuximab"},{"type":"DRUG","name":"Fluorouracil"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Leucovorin"},{"type":"DRUG","name":"Bevacizumab"}],"enrollment":260,"startDate":"2025-12-23","completionDate":"2029-04-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 years of age or older\n* Advanced or metastatic cancer of the breast or colon Part 1A: metastatic or advanced breast cancer or colorectal cancer for which no standard therapy is available Part 1B: metastatic or advanced breast cancer with disease progression after at least 1 line of treatment with an endocrine therapy and CDK4/6 inhibitor in the advanced or metastatic setting Part 1C: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 1D: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease Part 2A: metastatic or advanced breast cancer with disease progression after at least 1 prior line of CDK4/6 inhibitor and at least 1 prior line of endocrine therapy Part 2B: metastatic or advanced colorectal cancer with at least having received chemotherapy and/or targeted therapy if appropriate Part 2C: metastatic or advanced colorectal cancer without any prior chemotherapy for advanced or metastatic disease\n* Measurable disease\n* ECOG performance status 0 or 1\n\nExclusion Criteria:\n\n* Active malignancy within 3 years prior to enrollment\n* Known symptomatic brain metastases requiring steroids\n* Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term\n* Prior irradiation to \\>25% of the bone marrow\n* Hypertension that cannot be controlled by optimal medical therapy\n* Renal impairment\n* Hepatic dysfunction\n* Cardiac abnormalities\n* Active bleeding disorder\n* Active or history of clinically significant GI disease\n* Other unacceptable abnormalities as defined by protocol","locations":[{"facility":"City of Hope (City of Hope National Medical Center, City of Hope Medical Center)","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest, LLC","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy","city":"Long Island City","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center 53rd street.","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center - Main Campus","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center - Conroe","city":"Conroe","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas - M.D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - West Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - League City","city":"League City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas, MD Anderson Cancer Center - Sugar Land","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"Val-de-marne","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Poitiers","city":"Poitiers","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"Barcelona [barcelona]","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario HM Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Part 1 (Dose Escalation): Number of participants with Dose-Limiting Toxicities (DLT)","Part 1 (Dose Escalation): Number of participants with laboratory abnormalities","Part 1 (Dose Escalation): Incidence of Adverse Events (AEs)","Part 2 (Dose Expansion): Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["breast-cancer","colorectal-cancer","als"],"drugSlugs":[],"locationSlugs":["duarte-california","grand-rapids-michigan","long-island-city-new-york","new-york-new-york","conroe-texas","houston-texas","league-city-texas","san-antonio-texas","sugar-land-texas","west-valley-city-utah","villejuif-france","poitiers-france","barcelona-spain","madrid-spain"],"enrichment":{"headline":"Phase 1: testing PF-08032562 for Advanced Breast Cancer","inPlainEnglish":"This study wants to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.","whoItsFor":["Ages 18 Years to any","18 years of age or older","how well you can do daily activities (ECOG score) 0 or 1"],"whoShouldSkip":["Active malignancy within 3 years prior to enrollment","Known symptomatic brain metastases requiring steroids","Advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term","Prior irradiation to \\>25% of the bone marrow","Hypertension that cannot be controlled by optimal medical therapy","Hepatic dysfunction","Cardiac abnormalities"],"whatHappens":"If you join, the listed intervention(s) are PF-08032562, Fulvestrant, or Cetuximab. The registry lists allocation as randomized. This study wants to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 260 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.081Z"},{"nctId":"NCT07320014","title":"Descriptive Study of Circulating Gene or Protein Inflammatory Biomarkers and Bioimpedance Parameters in a Population of Patients Hospitalized for Decompensated Heart Failure With Preserved or Mildly Reduced Cardiac Function","officialTitle":"Inflammatory Profile in Patients Hospitalized for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Its Correlation With Bioimpedance Parameters and Other Biomarkers With Prognostic Value","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","sponsorClass":"OTHER","summary":"The goal of this observational study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems.\n\nHeart failure continues to be a major cause of hospital admissions and death in our society. Because of this, it is very important for healthcare professionals to identify which patients are at higher risk of complications, so that we can provide the best possible treatment and follow-up. One method we use to help predict how the disease may evolve is the study of biomarkers, which are measurable biological substances that can help detect, monitor, or treat illnesses in a more personalized way.\n\nIn this study, the investigators will measure mainly inflammatory biomarkers that will be analyzed from a blood sample taken during hospital stay after being diagnosed with heart failure with preserved or mildly reduced ejection fraction. Any important health events that happen during the next six months after patients are discharged from hospital will also be recorded.\n\nIn addition, it is known that more than 2,000 diseases are known to be caused by changes in specific genes. In the case of cardiomyopathies-heart muscle diseases that can lead to heart failure-genetic causes vary depending on the type, and studies suggest that between 10% and 50% of cases may have a genetic origin. Identifying genetic markers linked to heart failure with preserved or mildly reduced ejection fraction may help improve prevention, treatment, and risk assessment, as some genetic changes may be associated with repeated cardiovascular events. By studying not only circulating biomarkers but also genetic factors, the investigators hope to better understand whether certain gene alterations may increase a person's tendency to experience additional heart-related events.\n\nThis is an observational study, which means that medical care and treatment will be exactly the same whether patients choose to participate or not. Participation involves allowing researchers to collect relevant information from medical records and agreeing to the collection of two or three small additional blood samples for research purposes. These samples will be used to measure the biomarkers and to analyze genes in the white blood cell fraction obtained from the same tubes.","conditions":["Inflammation Biomarkers","Heart Failure"],"keywords":["inflammatory profile","heart failure with preserved ejection fraction","heart failure with mildly reduced ejection fraction","bioimpedance"],"interventions":[{"type":"OTHER","name":"Inflammatory biomarker sample collection"}],"enrollment":112,"startDate":"2026-01-12","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years at recruitment.\n* Signed informed consent.\n* Hospitalization due to decompensated heart failure, based on Framingham criteria and elevated natriuretic peptides (N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) ≥450 pg/ml, or ≥900 pg/ml for patients with atrial fibrillation or flutter).\n* Left ventricular ejection fraction(LVEF) ≥40% and evidence of structural heart disease based on the presence of at least one of the following imaging criteria:\n\n  * Left atrial dilation: LA diameter ≥3.8 cm, or area ≥20 cm², or LA volume ≥55 ml, or indexed LA volume ≥29 ml/m².\n  * Left ventricular hypertrophy, defined as septal or posterior wall thickness ≥1.1 cm.\n  * Evidence of increased filling pressures, measured by septal or lateral E/e' ratio \\>15 or \\>12, respectively.\n\nExclusion Criteria:\n\n* Hemodynamic instability at the time of inclusion.\n* Heart failure secondary to acute myocardial infarction (AMI).\n* Pregnant or breastfeeding women.\n* Comorbidities that could influence the clinical course:\n\n  * COPD requiring long-term home oxygen therapy, oral corticosteroids, hospitalization due to exacerbation, or primary pulmonary arterial hypertension.\n  * Chronic treatment with immunosuppressants, corticosteroids, or IL-1 antagonists within the 6 months prior to inclusion.\n  * Confirmed active infection or patients currently receiving antibiotic treatment.\n  * Acute or chronic liver disease.\n  * Chronic kidney disease with eGFR \\<15 ml/min/1.73 m² or need for dialysis during hospitalization.\n  * Hematological disorders, such as blood dyscrasias or hemoglobin \\<9 g/dl on admission.\n  * Active oncological disease, except treated basal cell carcinoma or low-risk prostate cancer.\n  * Patients with limb amputation or carriers of pacemakers or defibrillators (due to possible errors in BIA measurements).\n  * Any disease associated with a life expectancy of less than one year, or patients expected to have difficulty adhering to the study protocol\n* Patients actively participating in other clinical trials involving investigational drugs at the time of inclusion.","locations":[{"facility":"Hospital Fundacion Jimenez Diaz","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ana Venegas","phone":"+34685286550","email":"ana.venegas@quironsalud.es"}],"primaryOutcomes":["Description of circulating inflammatory gene or protein biomarkers and other biomarkers with prognostic value in a population of patients hospitalized for acute HF.","Description of parameters obtained by bioimpedance analysis (BIA) in a population of patients hospitalized for decompensated HF with preserved or mildly reduced ejection fraction."],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["madrid-spain"],"enrichment":{"headline":"Not a traditional drug phase: Inflammatory biomarker sample collection for Inflammation Biomarkers","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to determine whether changes in the inflammatory profile of heart failure patients can help identify those who may have a worse prognosis or who might benefit more from specific treatments. In addition, we aim to explore whether certain genes or gene mutations are related to a higher risk of future cardiovascular problems.","whoItsFor":["Ages 18 Years to any","Age ≥18 years at recruitment","Hospitalization due to decompensated heart failure, based on Framingham criteria and elevated natriuretic peptides (N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) ≥450 pg/ml, or ≥900 pg/ml for patients with atrial fibrillation or flutter)","Left ventricular ejection fraction(LVEF) ≥40% and evidence of structural heart disease based on the presence of at least one of the following imaging criteria:","Left atrial dilation: LA diameter ≥3.8 cm, or area ≥20 cm², or LA volume ≥55 ml, or indexed LA volume ≥29 ml/m²","Left ventricular hypertrophy, defined as septal or posterior wall thickness ≥1.1 cm","Evidence of increased filling pressures, measured by septal or lateral E/e' ratio \\>15 or \\>12, respectively"],"whoShouldSkip":["Hemodynamic instability at the time of inclusion","Heart failure secondary to acute myocardial infarction (AMI)","Pregnant or breastfeeding women","Comorbidities that could influence the clinical course:","COPD requiring long-term home oxygen therapy, oral corticosteroids, hospitalization due to exacerbation, or primary pulmonary arterial hypertension","Chronic treatment with immunosuppressants, corticosteroids, or IL-1 antagonists within the 6 months prior to inclusion","Confirmed active infection or patients currently receiving antibiotic treatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 112 people at Madrid. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.443Z"},{"nctId":"NCT07321093","title":"A Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","officialTitle":"A Double-blind, Randomized Clinical Study of the Efficacy and Safety of BCD-281 in Patients With Relapsing-Remitting Multiple Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Biocad","sponsorClass":"INDUSTRY","summary":"The aim of this study is to compare the efficacy, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.","conditions":["Relapsing-remitting Multiple Sclerosis (RRMS)"],"keywords":["Multiple Sclerosis","anti CD20","monoclonal antibody"],"interventions":[{"type":"BIOLOGICAL","name":"BCD-281"},{"type":"BIOLOGICAL","name":"Ocrelizumab"}],"enrollment":292,"startDate":"2025-11-01","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provided written ICF to participate in the study.\n* Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF.\n* Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision).\n* Relapsing-remitting multiple sclerosis.\n* The total EDSS score 0-5.5 inclusive.\n* Documentary evidence of the following at the time of signing the ICF:\n\n  1. at least one relapse within the last12 months, and/or\n  2. 2 relapses within the last 24 months, and/or\n  3. at least 1 T1 Gd+ lesion detected on brain MRI and 1 relapse within 24 months prior to signing the ICF.\n* Presence of IgG antibodies to the Varicella-Zoster virus.\n* Neurological stability for 30 days prior to signing the ICF.\n* Subject's willingness to discontinue previously prescribed DMTs from the day of the first administration of the IP and throughout the study.\n* The ability of the subject to follow the Protocol procedures, according to the Investigator.\n* Willingness of subjects of both sexes and their sexual partners of childbearing potential to use reliable methods of contraception from the time of signing ICF, throughout the study and for 5 months after the last dose of the drug in this study.\n\nExclusion Criteria:\n\n* Primary progressive or secondary progressive MS.\n* MS duration of more than 10 years with EDSS score of ≤2.0 at screening.\n* Malignant form of MS.\n* Other medical conditions that can affect the assessment of clinical picture of the MS.\n* Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents.\n* Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS.\n* History of progressive multifocal leukoencephalopathy.\n* Any acute or exacerbated chronic infections detected during screening that may have a negative impact on subject's safety during the study therapy.\n* Concomitant diseases and/or conditions that may affect the assessment of the clinical picture of the underlying disease and/or significantly increase the risk of AEs during the study.\n* Known alcohol or drug addiction, or current signs of alcohol/drug addiction.\n* History of severe depression and/or a Beck Depression Inventory score of ≥16 at screening examination.\n* History of a malignant disease within 5 years prior to screening.\n* A diagnosis of HIV infection, hepatitis B or C .\n* Inability to provide the subject with venous access.\n* Pregnancy or breastfeeding, pregnancy planning and oocyte donation throughout the study and for 5 months after the last dose of ocrelizumab.\n* A history of severe allergic or anaphylactic reactions to humanized and/or murine monoclonal antibodies.\n* A history of using any prohibited medications or treatments defined in the study protocol.\n* Abnormal laboratory blood values, as specified in the study protocol.","locations":[{"facility":"LLC \"Medis\"","city":"Nizhny Novgorod","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marina Krasnova","phone":"+7 (812) 380 49 33","email":"krasnovam@biocad.ru"}],"primaryOutcomes":["Total number of T1 gadolinium-enhancing (Gd+) lesions up to Week 24."],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["nizhny-novgorod-russia"],"enrichment":{"headline":"Phase 3: testing BCD-281 for Relapsing-remitting Multiple Sclerosis (RRMS)","inPlainEnglish":"The aim of this study is to compare the how well it works, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.","whoItsFor":["Ages 18 Years to 55 Years","Provided written ICF to participate in the study","Male and female subjects aged 18 to 55 years inclusive at the time of signing the ICF","Diagnosis of multiple sclerosis, established in accordance with the McDonald criteria for the diagnosis of multiple sclerosis (2017 revision)","Relapsing-remitting multiple sclerosis","The total EDSS score 0-5.5 inclusive","Documentary evidence of the following at the time of signing the ICF:","at least one relapse within the last12 months, and/or"],"whoShouldSkip":["Primary progressive or secondary progressive MS","MS duration of more than 10 years with EDSS score of ≤2.0 at screening","Malignant form of MS","Other medical conditions that can affect the assessment of clinical picture of the MS","Inability to obtain high-quality MRI images and/or the presence of contraindications to MRI and the administration of gadolinium-containing contrast agents","Any comorbidities requiring treatment with systemic glucocorticoids and/or immunosuppressive drugs for the duration of the study, with the exception of MS","History of progressive multifocal leukoencephalopathy"],"whatHappens":"If you join, the listed intervention(s) are BCD-281, or Ocrelizumab. The registry lists allocation as randomized. The aim of this study is to compare the how well it works, safety profile, pharmacokinetics, pharmacodynamics, and immunogenicity of BCD-281 and the reference drug in subjects with relapsing multiple sclerosis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 292 people at Nizhny Novgorod. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.995Z"},{"nctId":"NCT07322003","title":"Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Prilenia","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Pridopidine"},{"type":"DRUG","name":"Placebo"}],"enrollment":500,"startDate":"2026-02-01","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","locations":[{"facility":"Barrow Neurological Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Pacific Medical Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado CU Anschutz Neurology","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas","city":"Fairway","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sean M. Healey & AMG Center for ALS","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Somnos Clinical Research","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eleanor and Lou Gehrig ALS Center at Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuroscience Department at LKSM at Temple University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Neurology","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine; McNair Medical Campus","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Washington","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genge Partners","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta","city":"Edmonton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McMaster University Medical Centre","city":"Hamilton","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux Universitaires de Marseille Timone","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Nice","city":"Nice","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospitalier Pitié-Salpêtrière","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre hospitalier régional universitaire de de Tours","city":"Tours","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"ALS outpatient department at Charité - university medicine Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"ALS Clinic Bonn University","city":"Bonn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical School Hannover, ALS Centre","city":"Hanover","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Jena","city":"Jena","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Schleswig-Holstein, Campus Luebeck","city":"Lübeck","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Ulm","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity College Dublin","city":"Dublin","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Campania \"Luigi Vanvitelli\"","city":"Caserta","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Clinico NEMO Fondazione Serena Onlus - ASST Niguarda Hospital","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Auxologico Italiano Ospedale San Luca","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Di Modena","city":"Modena","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Padova","city":"Padova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Torino","city":"Torino","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"UMC Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Neuromed","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linden sp. z o. o. sp. k.","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"City Clinic Research Sp. z o.o.","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital del Mar","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Bellvitge","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz - Carlos III","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Hospital Santiago de Compostela","city":"Santiago de Compostela","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari i Politècnic La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Studieenheten Akademiskt specialistcentrum","city":"Stockholm","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Umeå University Hospital","city":"Umeå","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"MDN Centre Queen Square Institute of Neurology","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Stoke University Hospital","city":"Stoke-on-Trent","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Prilenia Medical Information","phone":"857-574-5755","email":"MedInfo@prilenia.com"}],"primaryOutcomes":["Change from baseline through Week 26 and Week 48 in the Revised ALS Functional Rating Scale (ALSFRS-R) total score adjusted for mortality"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","san-francisco-california","aurora-colorado","jacksonville-florida","tampa-florida","atlanta-georgia","chicago-illinois","fairway-kansas","baltimore-maryland","boston-massachusetts","st-louis-missouri","lincoln-nebraska","new-york-new-york","philadelphia-pennsylvania","dallas-texas","houston-texas","seattle-washington","leuven-belgium","montreal-canada","edmonton-canada","hamilton-canada","lille-france","marseille-france","nice-france","paris-france","tours-france","berlin-germany","bonn-germany","hanover-germany","jena-germany","l-beck-germany","ulm-germany","dublin-ireland","jerusalem-israel","tel-aviv-israel","caserta-italy","milan-italy","modena-italy","padova-italy","torino-italy","utrecht-netherlands","bydgoszcz-poland","krakow-poland","warsaw-poland","barcelona-spain","madrid-spain","santiago-de-compostela-spain","valencia-spain","stockholm-sweden","ume-sweden","london-united-kingdom","stoke-on-trent-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Pridopidine for Amyotrophic Lateral Sclerosis","inPlainEnglish":"The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine.","whoItsFor":["Ages 18 Years to 80 Years","Definite ALS or Probable ALS using the El Escorial criteria","Symptom onset of ≤18 months at screening","Slow vital capacity (SVC) greater or equal to 60% predicted","Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening","Able to swallow a capsule"],"whoShouldSkip":["Presence of tracheostomy or permanent assisted ventilation","Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block","Clinically significant and/or unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and/or to study completion","Use of medications that prolong QT interval","Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides","Confirmed mutation in the SOD1, FUS or C9orf72 gene"],"whatHappens":"If you join, the listed intervention(s) are Pridopidine, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 500 people at 56 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.605Z"},{"nctId":"NCT07322159","title":"IASO206 in Patients With Relapsed/Refractory Multiple Myeloma","officialTitle":"An Exploratory Study of Safety and Efficacy of IASO206 in Patients With Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","sponsorClass":"OTHER","summary":"This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma","conditions":["Relapsed/Refractory Multiple Myeloma (RRMM)"],"keywords":[],"interventions":[{"type":"DRUG","name":"IASO206 injection"}],"enrollment":18,"startDate":"2026-01-08","completionDate":"2026-12-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 to 75 years old, male or female;\n* Diagnosed with relapsed/refractory multiple myeloma (RRMM) according to IMWG criteria, and have received at least 2 lines of treatment including one proteasome inhibitor and one immunomodulator; with documented disease progression (based on examination data) during or within 12 months after the latest anti-myeloma treatment (subjects whose last-line treatment was CAR-T therapy are not required to have progression within 12 months);\n* Presence of measurable lesions during screening according to any of the following criteria:\n\n  * Serum monoclonal protein (M-protein) level: ≥5 g/L f；\n  * Urine M protein level ≥200 mg/24 hours;\n  * Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;\n* BCMA expression on MM cells determined by flow cytometry or pathology immunohistochemistry;\n* ECOG score ≤ 2;\n* Expected survival time ≥12 weeks;\n* Subjects must have adequate organ function:\n* Hematology: Absolute neutrophil count (ANC) ≥ 1×10\\^9/L (supportive treatment within 7 days before laboratory test is not allowed); Absolute lymphocyte count (ALC) )≥0.3×10\\^9/L; platelets≥50×10\\^9/L (blood transfusion support within 7 days before laboratory test is not allowed); hemoglobin ≥60 g/L (without red blood cell \\[RBC\\] transfusion within 7 days before laboratory test);\n\n  * Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤1.5×upper limit of normal (ULN); serum total bilirubin≤1.5×ULN;\n  * Renal function: creatinine clearance calculated according to Cockcroft-Gault formula≥ 40 ml/min.\n  * Coagulation function: fibrinogen ≥1.0 g/L; activated partial thromboplastin time≤1.5×ULN, prothrombin time (PT)≤1.5×ULN;\n  * Blood oxygen saturation\\>91%;\n  * Left ventricular ejection fraction (LVEF) ≥50%;\n* Subjects and their spouses agree to use effective contraceptive methods with tools or drugs from the time the subject signs the informed consent form until one year after administration;\n* Subjects must sign a written informed consent form approved by the ethics committee before initiating the screening process.\n\nExclusion Criteria:\n\n* Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;\n* Multiple myeloma patients with plasma cell leukemia;\n* Patients with amyloidosis;\n* Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);\n* Patients who have received previous BCMA-targeted therapy;\n* Patients who have received plasma cell-targeted cellular therapy within 3 months before the screening period, or in whom received cellular therapy products can still be detected in peripheral blood;\n* Patients who have received other anti-tumor treatments requires an appropriate washout period：\n\n  * Received Bendamustine, fludalabine or high-dose cyclophosphoyl within 9 months before enrollment，or；\n  * Received Monoclonal antibody treatment for multiple myeloma within 21 days before enrollment, or;\n  * Received cytotoxic chemotherapy or proteasome inhibitor treatment within 14 days before enrollment, or；\n  * Received immunomodulatory treatment within 7 days before enrollment, or;\n  * Received other anti-tumor treatments (including but not limited to experimental drugs) listed above within 14 days before enrollment or at least 5 half-lives (whichever is longer);\n* Patients requiring long-term use of therapeutic doses of corticosteroids during the study period (defined as prednisone or equivalent \\>20 mg/day), except for physiological replacement, topical, and inhaled use;\n* Severe heart diseases：including but not limited to unstable angina, myocardial infarction (within 6 months before screening), congestive heart failure (New York Heart Association \\[NYHA\\] classification ≥ grade III), severe arrhythmia，hypertension that cannot be controlled by medication;\n* Unstable systemic diseases judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases；\n* Patient who needs chronic use of immunosuppressive agents;\n* Patients with malignant tumors other than multiple myeloma within 5 years before screening, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical resection, and those after radical resection Ductal carcinoma in situ of breast and papillary thyroid carcinoma;\n* Patients with a history of solid organ transplantation;\n* Major surgery history within 2 weeks before entering the study, or scheduled surgery during the study period or within 2 weeks after the study treatment；\n* Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc. infections;\n* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and detectable hepatitis B virus (HBV) DNA in peripheral blood; hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus ( HCV) RNA positive; human immunodeficiency virus (HIV) antibody positive; cytomegalovirus (CMV) DNA test positive; syphilis test positive;\n* Patients who have received inactivated vaccines within 4 weeks before enrollment;\n* Women who are pregnant or breastfeeding;\n* Patients with mental illness, consciousness disorder, or central nervous system diseases, including but not limited to epilepsy or a history of Parkinson's disease;\n* Known severe allergic reaction to IASO206 or its formulation components (such as tocilizumab);\n* Patients with unresolved non-hematological toxic reactions from previous treatments, which have not returned to baseline or ≤Grade 1 (except for alopecia and Grade 2 peripheral neuropathy);\n* Other situations considered unsuitable by the investigator.","locations":[{"facility":"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The incidence and severity of adverse events（AEs）"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":["car-t"],"locationSlugs":["tianjin-china"],"enrichment":{"headline":"Early phase 1: testing IASO206 injection for Relapsed/Refractory Multiple Myeloma (RRMM)","inPlainEnglish":"This study is an open-label, single-arm early exploratory clinical study, aiming to measure the safety, tolerability and preliminary how well it works of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma","whoItsFor":["Ages 18 Years to 75 Years","18 to 75 years old, male or female;","Presence of measurable lesions during screening according to any of the following criteria:","Serum monoclonal protein (M-protein) level: ≥5 g/L f；","Urine M protein level ≥200 mg/24 hours;","Light chain multiple myeloma without measurable lesions in serum or urine: the affected serum free light chain ≥100 mg/L with abnormal serum κ/λ free light chain ratio;","BCMA expression on MM cells determined by flow cytometry or pathology immunohistochemistry;","Expected survival time ≥12 weeks;"],"whoShouldSkip":["Patients with suspected or confirmed central nervous system involvement by plasma cell neoplasms;","Multiple myeloma patients with plasma cell leukemia;","Patients with amyloidosis;","Patients who have received autologous hematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks before enrollment, or have a history of allogeneic hematopoietic stem cell transplantation (Allo-HSCT);","Patients who have received previous BCMA-targeted therapy;","Patients who have received plasma cell-targeted cellular therapy within 3 months before the screening period, or in whom received cellular therapy products can still be detected in peripheral blood;","Patients who have received other anti-tumor treatments requires an appropriate washout period："],"whatHappens":"If you join, the listed intervention(s) are IASO206 injection. The registry lists allocation as na. This study is an open-label, single-arm early exploratory clinical study, aiming to measure the safety, tolerability and preliminary how well it works of IASO206 Injection(In Vivo CAR-T) in Patients with Relapsed/Refractory Multiple Myeloma","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 18 people at Tianjin. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.483Z"},{"nctId":"NCT07322367","title":"A Mobile Patient Health Technology Intervention for Improving Lung Cancer Screening Rates in Eligible High Risk Patients","officialTitle":"A Pragmatic Randomized-Controlled Learning Health System Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Wake Forest University Health Sciences","sponsorClass":"OTHER","summary":"To evaluate the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomized controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.","conditions":["Lung Cancer"],"keywords":[],"interventions":[{"type":"OTHER","name":"Portal Message with Reminder Text Messages"},{"type":"OTHER","name":"Text Message with Reminder Text Messages"},{"type":"OTHER","name":"Portal message only"},{"type":"OTHER","name":"Usual Care"}],"enrollment":27000,"startDate":"2026-03-25","completionDate":"2027-01","sex":"ALL","minAge":"50 Years","maxAge":"77 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nEligible patients will:\n\n* Meet the Medicare criteria for lung cancer screening, as updated in February 2022:\n* Age 50 - 77 years\n* Smoked at least 20 pack years\n* Current smoker or quit smoking within the past 15 years\n* Be established with a primary care provider within the Atrium Health Wake Forest Baptist health network (defined as having completed at least 1 primary care appointment in the past 6 months or have completed at least 2 primary care appointments within the past 18 months or being scheduled to see a health network primary care provider within the next 30 days).\n* Have a patient portal account or cellphone number listed in the electronic health record\n* Have a North Carolina address listed in the electronic health record\n\nExclusion Criteria:\n\nThe following patients will be excluded:\n\n* Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)\n* Those for whom lung cancer screening would be or may be inappropriate:\n\nelectronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure exclusion criteria based on significant comorbidities and/or frailty.","locations":[{"facility":"Atrium Health Wake Forest Baptist","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Coordinator","phone":"704-355-2000","email":"Aliza.randazzo@advocatehealth.org"},{"name":"Brent Heideman, Jr., MD","phone":"","email":"brent.heideman@advocatehealth.org"}],"primaryOutcomes":["Number of Participants to Complete Lung Screening CT - Primary Effectiveness"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["winston-salem-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Portal Message with Reminder Text Messages for Lung Cancer","inPlainEnglish":"To measure the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomly assigned controlled trial across an academic Learning Health System. The trial will contrast several approaches to participant outreach and will specifically target engaging fully powered cohorts of racial/ethnic minorities and rural residents.","whoItsFor":["Ages 50 Years to 77 Years","Eligible patients will:","Meet the Medicare criteria for lung cancer screening, as updated in February 2022:","Smoked at least 20 pack years","Current smoker or quit smoking within the past 15 years","Have a patient portal account or cellphone number listed in the electronic health record","Have a North Carolina address listed in the electronic health record"],"whoShouldSkip":["The following patients will be excluded:","Patients flagged as needing a language interpreter in the electronic health record for any language other than Spanish (electronic messages and intervention are deliverable in English or Spanish only)","Those for whom lung cancer screening would be or may be inappropriate:","electronic health record Prior history of lung cancer electronic health record Chest CT within the last 12 months electronic health record Those meeting the HEDIS COL-E measure"],"whatHappens":"If you join, the listed intervention(s) are Portal Message with Reminder Text Messages, Text Message with Reminder Text Messages, or Portal message only. The registry lists allocation as randomized. To measure the real-world effectiveness and implementation strategies for mPATH-Lung, investigators propose a pragmatic, randomly assigned controlled trial across an academic Learning Health System.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 27,000 people at Winston-Salem. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.723Z"},{"nctId":"NCT07323524","title":"Dapagliflozin in Active Lupus Nephritis","officialTitle":"Sodium-Glucose Co-Transporter-2 Inhibitors in Lupus Nephritis","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Brigham and Women's Hospital","sponsorClass":"OTHER","summary":"Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease. This pilot and feasibility randomized clinical trial will test the use of dapagliflozin versus placebo in addition to standard of care treatment for patients with early and active lupus nephritis, a group who has not been included in past trials.","conditions":["Lupus Nephritis (LN)"],"keywords":["dapagliflozin","SGLT2 inhibitor","safety","feasibility","pilot trial"],"interventions":[{"type":"DRUG","name":"Dapagliflozin (10Mg Tab) along with standard medical therapy"},{"type":"DRUG","name":"Placebo"}],"enrollment":33,"startDate":"2026-05-22","completionDate":"2028-07-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* • Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN\n\n  * Active (new or relapsing) LN within the prior six months, with at least one of the following:\n\n    * Kidney biopsy with activity index \\>2 and/or\n    * Active urinary sediment (\\>5 RBCs, \\>5 WBCs, or cellular casts)\n  * Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and/or B cell depleting therapies\n  * Recent or ongoing glucocorticoids use for active LN within the past 6 months\n  * Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated\n  * Estimated ≥0.5 g/g 24 hr proteinuria or ≥0.3 mg/g 24 hr microalbuminuria at enrollment (on first morning urine)\n  * Ability to given informed consent\n\nExclusion Criteria:\n\n* GFR \\< 25 ml/min/1.73m2\n\n  * Acute kidney injury at study enrollment (\\>50 percent rise in creatinine within 90 days)\n  * Type I diabetes, underweight (BMI \\<18.5), active malignancy, active infection, or recurrent genitourinary infections\n  * For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception\n  * Current use of \\>1mg/kg/day prednisone equivalent\n  * Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Karen H Costenbader, MD, MPH","phone":"(617) 525-8785","email":"kcostenbader@bwh.harvard.edu"},{"name":"April M Jorge, MD","phone":"617-643-9624","email":"amjorge@mgh.harvard.edu"}],"primaryOutcomes":["Proportion of eligible enrolled"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease","lupus"],"drugSlugs":["dapagliflozin"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 4: testing Dapagliflozin (10Mg Tab) along with standard medical therapy for Lupus Nephritis (LN)","inPlainEnglish":"Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure. Sodium-glucose co-transporter-2 inhibitors, including dapagliflozin, are known to improve outcomes for people with other causes of chronic kidney disease.","whoItsFor":["Ages 18 Years to 70 Years","Age 18-70 years, fulfilling 2012 SLICC or 2019 ACR/EULAR criteria for SLE, with biopsy-proven class III, IV and/or V LN","Active (new or relapsing) LN within the prior six months, with at least one of the following:","Kidney biopsy with activity index \\>2 and/or","Active urinary sediment (\\>5 RBCs, \\>5 WBCs, or cellular casts)","Receiving standard-of-care immunosuppression regimen for active LN, including mycophenolate, cyclophosphamide, belimumab, azathioprine, a calcineurin inhibitor, and/or B cell depleting therapies","Recent or ongoing glucocorticoids use for active LN within the past 6 months","Receiving standard-of-care antimalarial therapy and RAAS blockade, unless contraindicated"],"whoShouldSkip":["GFR \\< 25 ml/min/1.73m2","Acute kidney injury at study enrollment (\\>50 percent rise in creatinine within 90 days)","Type I diabetes, underweight (body-mass index (BMI) \\<18.5), active malignancy, active infection, or recurrent genitourinary infections","For females: pregnancy, or desiring of pregnancy and not using contraception, or unable to use contraception","Current use of \\>1mg/kg/day prednisone equivalent","Current or prior use of SGLT2 inhibitors or GLP-1 receptor agonists"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin (10Mg Tab) along with standard medical therapy, or Placebo. The registry lists allocation as randomized. Lupus nephritis is a chronic and life-threatening autoimmune cause of kidney disease that predominately impacts young people and can lead to kidney failure.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 33 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.270Z"},{"nctId":"NCT07325214","title":"Chemotherapy With or Without IMD10 (Focused Ultrasound) in the Treatment of Borderline Resectable or Locally Advanced Pancreatic Cancer","officialTitle":"A Randomized, Multicenter, Multiregional, Pivotal Clinical Trial to Evaluate the Safety and Efficacy of IMD10 (Focused Ultrasound) in Combination With the Chemotherapy Regimen Consisting of Irinotecan Hydrochloride, Oxaliplatin, Fluorouracil (5-FU) and Leucovorin Improves Overall Survival Compared With the Chemotherapy Regimen Alone in Patients With Borderline Resectable Pancreatic Cancer or Locally Advanced Pancreatic Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"IMGT Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this Interventional clinical trial is to evaluate safety and efficacy of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.","conditions":["Pancreatic Cancer","Borderline Resectable Pancreatic Cancer","Locally Advanced Pancreatic Cancer"],"keywords":["Focused Ultrasound"],"interventions":[{"type":"DEVICE","name":"IMD10"},{"type":"DRUG","name":"chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]"}],"enrollment":366,"startDate":"2026-11-04","completionDate":"2030-01","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAn individual must meet all the following criteria:\n\n-1. Willing and able to understand and sign an ICF and to comply with all aspects of the protocol\n\n* 2\\. Aged between 18 and 85 years, inclusive\n* 3\\. Histologically or cytologically, pathologically confirmed diagnosis of PDAC.\n* 4\\. Classification as BRPC or LAPC according to the NCCN Guidelines (The latest Edition) by radiologic test (CT or MRI), eligible for chemotherapy regimen within 4 weeks of the screening visit\n* 5\\. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit.\n* 6\\. The ECOG performance status 0 or 1\n* 7\\. Trial participant having laboratory values defined as:\n\n  \\-- Neutrophil count ≥ 1.5 x 109/L\n  * Platelet count ≥ 100 x 109/L\n  * AST and ALT ≤ 2.5 x ULN\n  * Serum creatinine ≤ 1.5 x ULN\n* 8\\. Life expectancy is more than 12 weeks\n* 9\\. A female is eligible to trial participate if not pregnant, not breast feeding -and either a woman not of childbearing potential or, if a woman of childbearing potential agrees to use highly effective methods of contraception from screening to EOS\n* 10\\. A male trial participant with female partner(s) of childbearing potential agrees to use highly effective methods of contraception from screening to EOS\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participating in this clinical trial:\n\n* 1\\. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor.\n* 2\\. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass\n* 3\\. Targeted tumor(s) is not clearly visible with IMD10.\n* 4\\. Tumor is not treatable by the working range of IMD10\n* 5\\. Patient has difficulty in lying in supine position.\n* 6\\. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial\n* 7\\. Known, or ongoing receipt at the time of screening, of anti-tumor therapy for pancreatic cancer including chemotherapy, radiation, and/or surgery\n* 8\\. A cardiovascular condition at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:\n\n  * Class III or IV heart failure according to New York Heart Association (NYHA) classification\n\n    * Acute coronary syndrome (unstable angina or myocardial infarction) within the last 24 weeks --③ Uncontrolled heart arrhythmia\n\n      * Other clinically significant cardiovascular abnormalities as determined by the investigator\n* 9\\. Known history at the time of the screening visit that deems trial participation inappropriate due to one or more of the following:\n\n  * Other uncontrolled chronic infectious diseases\n\n    * Active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, etc.)\n\n      * Congenital or acquired immunodeficiency diseases, such as cellular immunodeficiency, hypogammaglobulinemia, and hypergammaglobulinemia.\n\n        * Clinically significant mental illness\n* 10\\. Known history of malignancies other than pancreatic cancer within the last 2 years\n* 11\\. Known history of major surgery within 4 weeks of the cycle 1 day 1 (C1D1)\n* 12\\. Pregnant and breastfeeding women\n* 13\\. Participating in another drug/device clinical trial or have participated in another drug/device clinical trial within 4 weeks of C1D1\n* 14\\. Trial participation in the clinical trial is deemed inappropriate at the investigator's discretion, either for ethical reasons or due to potential impact on the clinical trial's outcome","locations":[{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Virginia Medical Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital,","city":"Gyeonggi-do","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeongmin Jang","phone":"+82-70-5080-2438","email":"jeongmin.jang@nanoimgt.com"}],"primaryOutcomes":["Overall Survival"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["boston-massachusetts","san-antonio-texas","charlottesville-virginia","gyeonggi-do-south-korea","seoul-south-korea"],"enrichment":{"headline":"Not a traditional drug phase: testing chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin] for Pancreatic Cancer","inPlainEnglish":"The purpose of this treatment clinical trial is to evaluate safety and how well it works of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.","whoItsFor":["Ages 18 Years to 85 Years","An individual must meet all the following criteria:","2\\. Aged between 18 and 85 years, inclusive","3\\. Histologically or cytologically, pathologically confirmed diagnosis of PDAC","4\\. Classification as BRPC or LAPC according to the NCCN Guidelines (The latest Edition) by radiologic test (CT or MRI), eligible for chemotherapy regimen within 4 weeks of the screening visit","5\\. Must have at least 1 measurable lesion per RECIST 1.1 criteria at the screening visit","6\\. The how well you can do daily activities (ECOG score) 0 or 1","7\\. Trial participant having laboratory values defined as:"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participating in this clinical trial:","1\\. The presence of a cystic lesion within tumor to be treated, or at the pancreas adjacent to the treated tumor","2\\. Extensive scars or surgical clips observed in the region through which the ultrasound beam will pass","3\\. Targeted tumor(s) is not clearly visible with IMD10","4\\. Tumor is not treatable by the working range of IMD10","5\\. Patient has difficulty in lying in supine position","6\\. Known history of severe hypersensitivity to ultrasound gel or to chemotherapies (irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin) used in this clinical trial"],"whatHappens":"If you join, the listed intervention(s) are IMD10, or chemotherapy regimen [irinotecan hydrochloride, oxaliplatin, fluorouracil (5-FU) and leucovorin]. The registry lists allocation as randomized. The purpose of this treatment clinical trial is to evaluate safety and how well it works of 'IMD10 (focused ultrasound)' in the treatment of borderline resectable pancreatic cancer or locally advanced pancreatic cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 366 people at 5 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.442Z"},{"nctId":"NCT07326566","title":"Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII","officialTitle":"A Phase 2 Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Silevertinib, an Oral EGFR Inhibitor, in Combination With Temozolomide in Patients With Newly Diagnosed Glioblastoma With Unmethylated MGMT Promoter and EGFRvIII","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Black Diamond Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.\n\nSpecifically, this study is being done to find answers to the following questions:\n\n* How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?\n* What are the side effects participants have when taking the study drug (silevertinib combined with temozolomide)?\n* Can the study drug (silevertinib combined with temozolomide) help participants with GBM live longer without disease progression compared to treatment with temozolomide alone?","conditions":["Glioblastoma (GBM)","Newly Diagnosed Glioblastoma","GBM","Glioblastoma Multiforme (GBM)","Glioma","Central Nervous System Diseases","Brain Cancer"],"keywords":["EGFR","Glioblastoma","Unmethylated","Unmethylated MGMT promoter","Newly Diagnosed","temozolomide","Temodar","silevertinib","BDTX-1535","EGFR alterations","epidermal growth factor receptor","EGFRvIII","epidermal growth factor receptor (EGFR)"],"interventions":[{"type":"DRUG","name":"silevertinib in combination with temozolomide"},{"type":"DRUG","name":"temozolomide (TMZ)"}],"enrollment":162,"startDate":"2026-05-05","completionDate":"2028-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT).\n* Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification).\n* For Part 1 (Safety Lead-in) ONLY: EGFR alterations.\n* For Part 2 (Randomized, Controlled Trial) ONLY: EGFRvIII.\n* For Part 2 (Randomized, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay.\n* No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy.\n* At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression.\n\nKey Exclusion Criteria:\n\n* Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri.\n* Progression of GBM prior to Enrollment, Screening, or Randomization.\n* Biopsy-only/no resectional surgery.\n* Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy.\n* Intent to use Optune® (TTF).\n* Significant other uncontrolled health conditions or other malignancies.","locations":[{"facility":"University of Alabama at Birmingham O'Neal Comprehensive Cancer Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSD Moores Cancer Center","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Sibley Memorial Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Oncology Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maine Health Cancer Care and Blood Disorders - Scarborough","city":"Scarborough","state":"Maine","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Sidney Kimmel Cancer Center - Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Cancer- Detroit","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Levine Cancer Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine Siteman Cancer Center","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Health","city":"Summit","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health Center for Advanced Medicine - Brain Tumor Center","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Wake Forest Baptist","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Taussig Cancer Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prisma Health","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute, University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VCU Massey Comprehensive Cancer Center","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Carbone Cancer Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Black Diamond Therapeutics Clinical Trial Navigation Service","phone":"(866) 955-4397","email":"blackdiamondtx@careboxhealth.com"}],"primaryOutcomes":["Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","springdale-arkansas","la-jolla-california","los-angeles-california","orange-california","palo-alto-california","new-haven-connecticut","washington-d-c-district-of-columbia","miami-florida","tampa-florida","atlanta-georgia","scarborough-maine","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","detroit-michigan","minneapolis-minnesota","st-louis-missouri","omaha-nebraska","hackensack-new-jersey","new-brunswick-new-jersey","summit-new-jersey","lake-success-new-york","new-york-new-york","the-bronx-new-york","winston-salem-north-carolina","cleveland-ohio","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","greenville-south-carolina","houston-texas","salt-lake-city-utah","fairfax-virginia","richmond-virginia","madison-wisconsin"],"enrichment":{"headline":"Phase 2: testing silevertinib in combination with temozolomide for Glioblastoma (GBM)","inPlainEnglish":"This study wants to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting. Specifically, this study is being done to find answers to the following questions: * How much of the study drugs (silevertinib combined with temozolomide) should be given to participants with GBM?","whoItsFor":["Ages 18 Years to any","Newly diagnosed histologically confirmed glioblastoma that is isocitrate dehydrogenase wild type (IDH-WT)","Positive EGFR status in the brain tumor as determined by a commercially available test or validated laboratory assay (CLIA or comparable certification)","For Part 1 (Safety Lead-in) ONLY: EGFR alterations","For Part 2 (randomly assigned, Controlled Trial) ONLY: EGFRvIII","For Part 2 (randomly assigned, Controlled Trial) ONLY: Unmethylated MGMT promoter tumor status based on a validated assay","No treatment for newly diagnosed GBM other than surgery followed by standard-of-care adjuvant postoperative radiation (54 to 60 Gy) and TMZ chemotherapy","At least 4 weeks since completion of radiation therapy, with a post-radiation MRI showing no progression"],"whoShouldSkip":["Recurrent multifocal disease, metastatic, leptomeningeal, or extracranial GBM, or gliomatosis cerebri","Progression of GBM prior to Enrollment, Screening, or Randomization","Biopsy-only/no resectional surgery","Prior or concomitant treatment for GBM with an EGFR-targeting agent, including silevertinib, bevacizumab, cytotoxic chemotherapy, immunotherapy, experimental therapies, Gliadel wafers, GammaTile®, or other intratumoral or intracavitary antineoplastic therapy","Intent to use Optune® (TTF)","Significant other uncontrolled health conditions or other malignancies"],"whatHappens":"If you join, the listed intervention(s) are silevertinib in combination with temozolomide, or temozolomide (TMZ). The registry lists allocation as randomized. This study wants to see if combining silevertinib with temozolomide after surgery and radiotherapy helps treat newly diagnosed glioblastoma (GBM) better than using temozolomide alone in the maintenance setting.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 162 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.481Z"},{"nctId":"NCT07327593","title":"Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study","officialTitle":"Exercise Induced Hypoalgesia in Pain-free Stroke and Healthy Populations: a Cohort Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Neuron, Spain","sponsorClass":"OTHER","summary":"Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH). This phenomenon has been studied since 1979 and has shown improvements in pain thresholds with both aerobic and resistance training in healthy, pain-free populations and different chronic pain conditions.\n\nAlthough there has been extensive research on EIH in healthy populations and those with chronic musculoskeletal pain, surprisingly little attention has been given to individuals with neurological pathologies. Chronic pain is found in more than 50% of patients after stroke, and 70% of affected individuals experience pain on daily activities. Reported prevalences of post-stroke pain (PSP) between different studies, but there is a general consensus that it is an underreported phenomenon. Patients with pain experience greater cognitive and functional decline, fatigue, depression and lower quality of life.\n\nMultiple factors contribute to PSP, and various approaches exist to treat all the variables influencing it. This study aims to compare the effects of exercise on pain perception in healthy individuals and stroke patients without pain, using the same cardiovascular training protocol, to better understand the mechanisms of EIH and its maintenance after stroke, ultimately aiming to improve the treatment of people with stroke.","conditions":["Stroke","Pain","Exercise Induced Hypoalgesia"],"keywords":["Stroke","Pain","Exercise induced hypoalgesia","Cardiovascular training"],"interventions":[{"type":"OTHER","name":"Cardiovascular training"}],"enrollment":60,"startDate":"2027-04","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nHealthy cohort:\n\n* Age \\> 18 years\n* No neurological damage\n* No medical conditions that could affect the test\n\nPost-stroke cohort:\n\n* Age \\> 18 years\n* Ischemic or hemorrhagic stroke (time since onset \\> 3 months)\n\nExclusion Criteria:\n\nHealthy cohort:\n\n* Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)\n* Pain in any location, of duration \\> 1 week in the 3 months preceding the trial.\n\nPost-stroke cohort:\n\n* Unable to participate in the test (no possibility of transfer or active pedaling)\n* Medical contraindication to cardiovascular training for any reason\n* Inability to follow instructions or communicate sensations during training\n* Other neurological pathology, cardiac pathology (unstable angina, arrhythmias, aortic or left ventricular problems, myocarditis, pericarditis), pulmonary pathology that affects the test (pulmonary embolisms, pulmonary hypertension, etc.), renal or metabolic problems (severe renal dysfunction, uncontrolled diabetes, etc.), acute infection or fever, neurosurgery within 6 weeks prior to inclusion in the study\n* Pain in any location, lasting \\> 1 week in the 3 months prior to the trial.\n* Use of beta-blockers, antidepressants, or any medication that may alter heart rate measurements","locations":[{"facility":"Neuron Madrid Río","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuron Nuevos Ministerios","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alejandro Herrera Rojas, Physical Therapist","phone":"+ 34 640944777","email":"aherrerar2003@gmail.com"},{"name":"Alfredo Lerín Calvo, Physical Therapist","phone":"+ 34 620187457","email":"alerin@neuronrehab.es"}],"primaryOutcomes":["Pressure pain thresholds","Conditioned pain modulation"],"hasResults":false,"conditionSlugs":["als","stroke","depression"],"drugSlugs":[],"locationSlugs":["madrid-spain"],"enrichment":{"headline":"Not a traditional drug phase: Cardiovascular training for Stroke","inPlainEnglish":"Exercise has shown multiple beneficial effects in both healthy and post-stroke populations. One of these is the acute reduction in sensitivity to painful stimuli, called exercise-induced hypoalgesia (EIH).","whoItsFor":["Ages 18 Years to any","No neurological damage","No medical conditions that could affect the test","Post-stroke cohort:","Ischemic or hemorrhagic stroke (time since onset \\> 3 months)"],"whoShouldSkip":["Any medical condition that could affect the test (respiratory, cardiovascular, metabolic diseases, for example)","Pain in any location, of duration \\> 1 week in the 3 months preceding the trial","Post-stroke cohort:","Unable to participate in the test (no possibility of transfer or active pedaling)","Medical contraindication to cardiovascular training for any reason","Inability to follow instructions or communicate sensations during training","Pain in any location, lasting \\> 1 week in the 3 months prior to the trial"],"whatHappens":"If you join, the listed intervention(s) are Cardiovascular training. The registry lists allocation as randomized. Exercise has shown multiple beneficial effects in both healthy and post-stroke populations.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.211Z"},{"nctId":"NCT07328685","title":"Basic Body Awareness Therapy in Individuals With Migraine","officialTitle":"Examining the Effectiveness of Basic Body Awareness Therapy in Individuals With Migraine","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Mustafa Kemal University","sponsorClass":"OTHER","summary":"One biopsychosocial approach proven effective in headache treatment is basic body awareness therapy. This study was planned to evaluate the effectiveness of basic body awareness training and lifestyle recommendations in individuals diagnosed with migraine. Functional status will be assessed using the Migraine-Related Disability Assessment Scale (MIDAS), sleep quality using the Jenkins Sleep Scale (JUS), and quality of life using the Headache Impact Test. Assessment of functional status, sleep quality, and quality of life will be performed before treatment and after treatment (at the end of week 8).","conditions":["Migraine"],"keywords":["migraine","functional status","sleep","quality of life"],"interventions":[{"type":"BEHAVIORAL","name":"Exercise"},{"type":"BEHAVIORAL","name":"Standart therapy"}],"enrollment":40,"startDate":"2026-01-02","completionDate":"2026-03-20","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with migraine,\n* Experiencing at least 3 migraine attacks per month,\n* Between the ages of 18 and 55 and who volunteer to participate in the study.\n\nExclusion Criteria:\n\n* History of secondary headaches,\n* Being pregnant,\n* Having any other neurological disease besides migraine,\n* Having other secondary headaches in addition to migraine,\n* History of malignancy,\n* Regularly practicing meditation, yoga, or mindfulness-based practices.","locations":[{"facility":"Hatay Mustafa Kemal University","city":"Antakya","state":"Hatay","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yasemin Karaaslan, PhD","phone":"0535 845 96 25","email":"ptyasemindeveci@gmail.com"}],"primaryOutcomes":["Pain Diary"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["antakya-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Exercise for Migraine","inPlainEnglish":"One biopsychosocial approach proven effective in headache treatment is basic body awareness therapy. This study was planned to measure the effectiveness of basic body awareness training and lifestyle recommendations in individuals diagnosed with migraine.","whoItsFor":["Ages 18 Years to 55 Years","Diagnosed with migraine,","Experiencing at least 3 migraine attacks per month,","Between the ages of 18 and 55 and who volunteer to participate in the study"],"whoShouldSkip":["History of secondary headaches,","Having any other neurological disease besides migraine,","Having other secondary headaches in addition to migraine,","History of malignancy,","Regularly practicing meditation, yoga, or mindfulness-based practices"],"whatHappens":"If you join, the listed intervention(s) are Exercise, or Standart therapy. The registry lists allocation as randomized. One biopsychosocial approach proven effective in headache treatment is basic body awareness therapy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Antakya. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.299Z"},{"nctId":"NCT07332143","title":"Psilocybin-Assisted Therapy","officialTitle":"The Safety and Acceptability of Psilocybin With Support and With Massed Prolonged Exposure Therapy for PTSD","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Emory University","sponsorClass":"OTHER","summary":"This pilot study will examine the safety, tolerability, acceptability, and efficacy of combination psilocybin + psychotherapy to decrease PTSD symptoms. Participants will be randomized into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.","conditions":["PTSD"],"keywords":["Psilocybin","PTSD","Supportive therapy","PE therapy"],"interventions":[{"type":"DRUG","name":"psilocybin"},{"type":"BEHAVIORAL","name":"Supportive Therapy"},{"type":"BEHAVIORAL","name":"Prolonged Exposure Therapy"}],"enrollment":150,"startDate":"2026-06-08","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Eligible participants must be over the age of 18. They must self-identify as military veterans, reservists, National Guard members, or active-duty servicemembers. Additionally, they must be seeking treatment for PTSD, which will be confirmed by a CAPS-5-R assessment. The criteria below will be applicable to all participants, regardless of study treatment arm.\n\nInclusion Criteria\n\n1. Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules.\n2. Able to speak and read English (due to standardization of outcome measures).\n3. Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated\n4. Are 18 years and older.\n5. Are able to swallow pills.\n6. Agree to have study visits video and/or audio recorded, including Medicine Session, Independent Rater assessments, and non-drug psychotherapy sessions.\n7. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.\n8. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.\n9. If able to become pregnant, participants must have a negative pregnancy test prior to study entry, at study entry, and prior to each Medicine Session. They must agree to use highly effective birth control for a month prior to the Medicine session and through 10 days after the Medicine session.\n10. Agree to the following lifestyle modifications: comply with requirements for fasting and refraining from certain medications prior to Medicine Session, not participate in any other interventional clinical trials during the duration of the treatment, and agree not to operate their vehicles (or heavy machinery) up to 24 hours after Medicine Session, and commit to medication dosing, therapy, and study procedures.\n\nExclusion Criteria\n\n1. Are not able to give adequate informed consent.\n2. Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives.\n3. Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation.\n4. Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).\n5. Have a history of or current bipolar type 1 disorder, primary psychotic disorder (e.g., schizophrenia), or secondary psychotic features (i.e., Major Depressive disorder with psychotic features.\n6. Have met criteria at any time during their life for amphetamine or cocaine substance use disorder or any drug of abuse the study physician determines to be unfit for the study.\n7. Meet criteria for current (past 3 months) moderate or severe substance use disorder, as defined by 4 or more DSM SUD criteria symptoms.\n8. Have a positive screen for any drug of abuse (amphetamines, etc.) on drug test administered in local community or on site unless being taken as prescribed by a physician.\n9. Any participant presenting current serious suicide risk, as determined through psychiatric interview and clinical judgment of the investigator will be excluded;\n\n   1. Suicidal ideation score of 4 or greater within the last 6 months.\n   2. Any suicidal behavior, including suicide attempts or preparatory acts, within the last 6 months of the assessment\n   3. However, history of suicide attempts is not an exclusion.\n10. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications.\n\n    Medical History\n11. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate, or any medical condition the study physician believes would pose a safety risk or interfere with the effects of the treatment.\n\n    1. This includes, but is not limited to, a history of myocardial infarction, cerebrovascular accident, or aneurysm.\n    2. Participants with other stable chronic medical problems may be enrolled if the site physician believes would not significantly increase the risk of Psilocybin administration or be likely to produce significant symptoms during the study that could interfere with study participation or be confused with side effects of the IMP.\n12. Have any unstable medical or central nervous system-related illness that would interfere with participation.\n13. Systolic blood pressure \\>= 140 mmHg or diastolic blood pressure \\>= 90 mmHg, measured in the supine position after at least five minutes at rest. If the initial blood pressure is \\>= 140/90 mmHg, up to three additional attempts before dosing visit are permitted. The study physician will manage blood pressure monitoring from baseline through 10 days after drug administration.\n14. Have a history of clinically significant arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n    a. Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs and confirmed by a cardiologist.\n15. Have a marked Baseline prolongation of QT/QTc interval e.g., repeated demonstration of a QTc interval \\> 450 milliseconds (ms) in males and \\>470 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth.\n16. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, family history of Long QT Syndrome).\n17. Have significant liver enzyme elevations as evidenced by total bilirubin \\>1.5mg/dL and/or ALT and AST (\\>two times upper limit of normal \\[ULN\\]) per baseline laboratory test.\n18. Creatinine clearance: \\<30 mL/min)\n19. Non-ambulatory or require two-person assistance with transfers (Fall risk)\n20. Body Mass Index (BMI) \\<18\n21. Are pregnant or nursing\n22. fMRI Scan Exclusions Only: History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.\n\n    1. NOTE: these ineligibility criteria preclude participants from undergoing a fmri scan but does not exclude them from the primary study participant and they may proceed without fMRI.","locations":[{"facility":"Emory University Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Wise, PhD","phone":"404-712-1035","email":"patstudy@emory.edu"},{"name":"Jessica Maples-Keller, PhD","phone":"404-778-2075","email":"jmaple2@emory.edu"}],"primaryOutcomes":["Change in PTSD symptoms based on CAPS-5-R total severity score","Change in PCL-5 score","Depression symptoms (PHQ-9)"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":["psilocybin"],"locationSlugs":["atlanta-georgia"],"enrichment":{"headline":"Phase 2: testing psilocybin for PTSD","inPlainEnglish":"This pilot study will examine the safety, tolerability, acceptability, and how well it works of combination psilocybin + psychotherapy to decrease PTSD symptoms. you would be randomly assigned into two different treatment groups, allowing the investigators to directly compare PE augmented with psilocybin and psilocybin-assisted psychotherapy.","whoItsFor":["Ages 18 Years to any","Meet criteria for PTSD due to trauma occurring at least 3 months prior based on CAPS-5-R diagnostic scoring rules","Able to speak and read English (due to standardization of outcome measures)","Willingness of participant to sign a release for the investigators to communicate with their primary care or mental health providers, if indicated","Are 18 years and older","Are able to swallow pills","Agree to have study visits video and/or audio recorded, including Medicine Session, Independent Rater assessments, and non-drug psychotherapy sessions","Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable"],"whoShouldSkip":["Have a family history bipolar disorder type 1 or a psychotic disorder in first degree relatives","Have any current problem which, in the opinion of the investigator or Medical Monitor, might interfere with participation","Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product)","Have a history of or current bipolar type 1 disorder, primary psychotic disorder (e.g., schizophrenia), or secondary psychotic features (i.e., Major Depressive disorder with psychotic features","Have met criteria at any time during their life for amphetamine or cocaine substance use disorder or any drug of abuse the study physician determines to be unfit for the study","Meet criteria for current (past 3 months) moderate or severe substance use disorder, as defined by 4 or more DSM SUD criteria symptoms","Have a positive screen for any drug of abuse (amphetamines, etc.) on drug test administered in local community or on site unless being taken as prescribed by a physician"],"whatHappens":"If you join, the listed intervention(s) are psilocybin, Supportive Therapy, or Prolonged Exposure Therapy. The registry lists allocation as randomized. This pilot study will examine the safety, tolerability, acceptability, and how well it works of combination psilocybin + psychotherapy to decrease PTSD symptoms.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at Atlanta. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.100Z"},{"nctId":"NCT07332455","title":"First-Time-in-Human Study of GSK5471713 in Adults With mCRPC","officialTitle":"A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Dose Optimization Study of GSK5471713 in Adult Participants With Metastatic Castration Resistant Prostate Cancer (mCRPC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This first-time-in-human study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a monotherapy in mCRPC.","conditions":["Neoplasms, Prostate"],"keywords":["Metastatic castration-resistant prostate cancer","First-Time-in-Human","GSK5471713","Prostate cancer"],"interventions":[{"type":"DRUG","name":"GSK5471713"}],"enrollment":54,"startDate":"2026-02-10","completionDate":"2028-03-24","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate.\n* Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT).\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 and life expectancy of ≥3 months (≥12 weeks).\n* Progression on ADT and \\>=1 prior Androgen receptor pathway inhibitors (ARPI) for Hormone-Sensitive Prostate Cancer (HSPC) or Castration resistant prostate cancer (CRPC) and received 1-2 prior taxane-based chemotherapy regimens. Participants should have received all approved standard-of-care therapies for which they are eligible, including biomarker directed therapy, in accordance with current clinical guidelines, unless a documented contraindication or another justified medical reason precluded their use.\n\nExclusion Criteria:\n\n* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality.\n* Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/exclusion criteria apply.","locations":[{"facility":"GSK Investigational Site","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Nijmegen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Seoul","state":"Seoul Teugbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Logroño","state":"La Rioja","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Number of participants with dose limiting toxicities (DLTs)","Number of participants with adverse events (AEs), and serious adverse events (SAEs)","Number of participants with adverse events (AEs), and serious adverse events (SAEs) by Severity","Number of participants with AEs leading to dose modifications"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["la-jolla-california","los-angeles-california","grand-rapids-michigan","philadelphia-pennsylvania","west-valley-city-utah","melbourne-australia","toronto-canada","montreal-canada","montpellier-france","villejuif-france","tokyo-japan","amsterdam-netherlands","nijmegen-netherlands","seoul-south-korea","logro-o-spain","barcelona-spain","m-laga-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing GSK5471713 for Neoplasms, Prostate","inPlainEnglish":"This first-time-in-human study will measure the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a this drug alone in mCRPC.","whoItsFor":["Ages 18 Years to any","Men only","Participants with mCRPC that have histologically or cytologically confirmed adenocarcinoma of the prostate","Participants with mCRPC that has prostate cancer progression while on Androgen deprivation therapy (ADT)","Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 and life expectancy of ≥3 months (≥12 weeks)"],"whoShouldSkip":["Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, or any histology different from adenocarcinoma","Impaired cardiac function or clinically significant cardiac disease","Any significant medical condition, such as uncontrolled infection or clinically significant laboratory abnormality","Prior therapy with Androgen receptor (AR) Degrader targeted therapy. Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are GSK5471713. The registry lists allocation as na. This first-time-in-human study will measure the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary clinical activity, and establish the benefit/risk of GSK5471713 given as a this drug alone in mCRPC.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.315Z"},{"nctId":"NCT07332481","title":"A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease","officialTitle":"A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"EMD Serono Research & Development Institute, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.","conditions":["Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)"],"keywords":["Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus (DLE)","Subacute Cutaneous Lupus Erythematosus (SCLE)","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus (ACLE)","Interferon gene signature"],"interventions":[{"type":"DRUG","name":"Enpatoran"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care (SoC)"}],"enrollment":202,"startDate":"2026-03-10","completionDate":"2029-05-24","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","locations":[{"facility":"Dermatology Research Associates - 300204025","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cohen Medical Centers","city":"Thousand Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GNP Research at Mark Jaffe, MD","city":"Cooper City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advance Medical Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diverse Clinical Research LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"D&H National Research Centers, Inc.","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida, Inc.","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University School of Medicine","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allen Arthritis","city":"Allen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis and Rheumatology Research Institute PLLC","city":"Allen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Care of Texas","city":"Corpus Christi","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Hunter Hospital - PARENT","city":"New Lambton Heights","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rheumatology Research Unit Sunshine Coast","city":"Maroochydore","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred Hospital - PARENT","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven - Internal Medicine","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica SER da Bahia","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"IPC MT Instituto de Pesquisas Clinicas do Mato Grosso","city":"Cuiabá","state":"Mato Grosso","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Freire Pesquisa Clinica","city":"Belo Horizonte","state":"Minas Gerais","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Câncer de Barretos - Fundação Pio XII - Hospital de Amor de Barretos","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCC V Plovdiv Sv. Archbishop Luka EOOD","city":"Plovdiv","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ambulatory for Specialized Medical Help - skin and venereal diseases","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ganzhou People's Hospital - 300165192","city":"Ganzhou","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Saint Etienne - Hôpital Nord - service de medecine interne","city":"Saint-Étienne-de-Montluc","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Tenon - service dermatologie et centre d'allergie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elbekliniken Buxtehude GmbH - Dermatologie","city":"Buxtehude","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité - Campus Charité Mitte - Klinik fuer Dermatol., Venerol., Allergologie","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Carl Gustav Carus TU Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chaim Sheba Medical Center - pt","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda USL Toscana Centro - Ospedale Piero Palagi","city":"Florence","state":"Firenze","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Università Campus Bio-Medico di Roma - UOC Reumatologia","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"JCHO Chukyo Hospital - Dept of Dermatology","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Chibahigashi National Hospital - Dept of Allergy/Rheumatology","city":"Chiba","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital of the University of Occupational and Environmental Health - Dept of Dermatology","city":"Kitakyushu-shi","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukushima Medical University Hospital - Dept of Rheumatology/Immunology","city":"Fukushima","state":"Fukushima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Asahikawa Medical Center - Dept of Gastroenterology","city":"Asahikawa-shi","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo City General Hospital - Dept of Rheumatology/Immunology","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe University Hospital - Dept of Immunology/Rheumatology","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kanazawa University Hospital - Dept of Rheumatology/Immunology","city":"Kanazawa","state":"Ishikawa-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama City University Hospital - Dept of Dermatology","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tohoku Medical and Pharmaceutical University Hospital - Dept of Hematology/Rheumatology","city":"Sendai","state":"Miyagi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital - Dept of Rheumatology/Immunology","city":"Okayama","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital - Dept of Dermatology","city":"Suita-shi","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital - Dept of Dermatology","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nihon University Itabashi Hospital - Dept of Hematology/Immunology","city":"tabashi City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Luke's International Hospital - Dept of Immunology/Allergy","city":"Chūōku","state":"Tokyo-To","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Yamanashi Hospital - Dept of Rheumatology/Immunology","city":"Chūō","state":"Yamanashi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Badan Klinicznych JCI","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Lublin - ETG NETWORK Sp. z o.o.","city":"Lublin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. z o.o.","city":"Malbork","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny im Fryderyka Chopina w Rzeszowie - Klinika Dermatologii i Dermatologii Onkologicznej","city":"Rzeszów","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"SOMED CR","city":"Rzeszów","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"REUMA CENTRUM Specjalistyczna Praktyka Lekarska Dr n. med. Jakub Trefler","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Zamosc","city":"Zamość","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Futuremeds S R L.","city":"Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Univerzitna nemocnica Bratislava, Nemocnica Stare Mesto - Dermatovenerologicka klinika","city":"Bratislava","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artromac n.o. - Reumatologicka ambulancia","city":"Košice","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Ansan Hospital - 300133335","city":"Ansan-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hanyang University Seoul Hospital - 300186741","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Santiago - Dermatology Unit","city":"Santiago de Compostela","state":"La Coruña","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario de Navarra - Nefrologia","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario de Valencia - Rheumatology","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsspital Basel - Klinik fuer Dermatologie","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital St. Gallen - Klinik f. Dermatologie, Venerologie u Allergologie","city":"Sankt Gallen","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chi Mei Medical Center - 300192662","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thammasat University Hospital","city":"Amphur Klongluang","state":"Changwat Pathum Thani","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital - 300195177","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Whipps Cross University Hospital - Dept of Rheumatology","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Freeman Hospital - Dept of Rheumatology","city":"Newcastle upon Tyne","state":"Tyne & Wear","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Communication Center","phone":"+49 6151 72 5200","email":"service@emdgroup.com"}],"primaryOutcomes":["Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["los-angeles-california","thousand-oaks-california","cooper-city-florida","miami-florida","tamarac-florida","tampa-florida","atlanta-georgia","troy-michigan","allen-texas","corpus-christi-texas","new-lambton-heights-australia","maroochydore-australia","melbourne-australia","leuven-belgium","fortaleza-brazil","salvador-brazil","cuiab-brazil","belo-horizonte-brazil","barretos-brazil","plovdiv-bulgaria","sofia-bulgaria","guangzhou-china","ganzhou-china","saint-tienne-de-montluc-france","paris-france","buxtehude-germany","berlin-germany","dresden-germany","ramat-gan-israel","florence-italy","roma-italy","nagoya-japan","chiba-japan","kitakyushu-shi-japan","fukushima-japan","asahikawa-shi-japan","sapporo-japan","kobe-japan","kanazawa-japan","yokohama-japan","sendai-japan","okayama-japan","suita-shi-japan","bunkyo-ku-japan","tabashi-city-japan","ch-ku-japan","ch-japan","krakow-poland","lublin-poland","malbork-poland","rzesz-w-poland","warsaw-poland","zamo-poland","brasov-romania","bratislava-slovakia","ko-ice-slovakia","ansan-si-south-korea","seongnam-si-south-korea","incheon-south-korea","seoul-south-korea","santiago-de-compostela-spain","pamplona-spain","valencia-spain","basel-switzerland","sankt-gallen-switzerland","taichung-taiwan","tainan-taiwan","amphur-klongluang-thailand","bangkok-thailand","london-united-kingdom","newcastle-upon-tyne-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Enpatoran for Systemic Lupus Erythematosus (SLE)","inPlainEnglish":"The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.","whoItsFor":["Ages 18 Years to 75 Years","Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory","Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE)","Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit","Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE","For participants with SLE:","Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria","Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening"],"whoShouldSkip":["Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE","Participants with drug-induced lupus (SLE or CLE)","Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed)","Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures","Other protocol-defined"],"whatHappens":"If you join, the listed intervention(s) are Enpatoran, Placebo, or Standard of care (SoC). The registry lists allocation as randomized. The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 202 people at 74 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.273Z"},{"nctId":"NCT07335289","title":"PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence","officialTitle":"PrEP4U: Assessing the Effectiveness of Integrated Same-Day Lenacapavir Initiation and Follow-up Choice on PrEP Persistence","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"PrEP4U is designed as a pragmatic, randomized implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating:\n\n* Same-day initiation based on rapid HIV testing, and\n* Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.\n\nThe primary hypothesis is that giving participants choice in follow-up location will improve PrEP persistence compared to a clinic-only model. Secondary analyses will evaluate safety of rapid testing, acceptability, and participant costs. Exploratory analyses will assess HIV incidence and resistance.\n\nFindings from PrEP4U will provide essential evidence to guide scalable, equitable, person-centered delivery models for lenacapavir PrEP in the U.S. and globally.","conditions":["HIV Pre-exposure Prophylaxis Use"],"keywords":["HIV PrEP","Injectable PrEP","Lenacapavir"],"interventions":[{"type":"OTHER","name":"Choice of follow up"},{"type":"OTHER","name":"Follow up via standard clinic"}],"enrollment":400,"startDate":"2026-07-17","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* HIV negative\n* Eligible for HIV PrEP per CDC guidelines\n* Able and willing to provide informed consent\n* Willing to receive injectable lenacapavir and adhere to study procedures\n* Residing inMassachusetts with expected availability for 6-month follow-up\n\nExclusion Criteria:\n\n* Known HIV infection at baseline\n* Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)\n* Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)\n* Participation in another interventional HIV prevention study\n* Any condition judged by the investigator to compromise safety or study integrity","locations":[{"facility":"Massachusetts General Hospital Sexual Health Clinic","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meighan Krows","phone":"617-726-2000","email":"mkrows@mgb.org"}],"primaryOutcomes":["PrEP persistence at 6 months"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Choice of follow up for HIV Pre-exposure Prophylaxis Use","inPlainEnglish":"PrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir. By integrating: * Same-day initiation based on rapid HIV testing, and * Choice of follow-up delivery location (home, community, or clinic) the study addresses two of the most pressing implementation questions for long-acting injectable PrEP.","whoItsFor":["Ages 18 Years to any","Eligible for HIV PrEP per CDC guidelines","Willing to receive injectable lenacapavir and adhere to study procedures","Residing inMassachusetts with expected availability for 6-month follow-up"],"whoShouldSkip":["Known HIV infection at baseline","Contraindication to lenacapavir injection (e.g., hypersensitivity, significant drug interactions)","Pregnancy at baseline (participants who become pregnant during the trial may remain enrolled if they choose)","Participation in another treatment HIV prevention study","Any condition judged by the investigator to compromise safety or study integrity"],"whatHappens":"If you join, the listed intervention(s) are Choice of follow up, or Follow up via standard clinic. The registry lists allocation as randomized. PrEP4U is designed as a pragmatic, randomly assigned implementation trial to test strategies that could directly inform real-world roll-out of lenacapavir.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.398Z"},{"nctId":"NCT07339111","title":"Phase 3 Pivotal Trial Comparing CARTISTEM® and Surgical Comparator for Knee Cartilage Lesions and Osteoarthritis","officialTitle":"Randomized, Prospective, Double Blind, Multi-Center, Phase 3 Pivotal Clinical Trial to Compare Efficacy and Safety of CARTISTEM® and Surgical Comparator in Subjects With Knee Cartilage Lesions and Osteoarthritis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Medipost, Inc.","sponsorClass":"INDUSTRY","summary":"This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis.\n\nCARTISTEM is a new treatment made of stem cells from donated umbilical cord blood mixed with a gel (hyaluronic acid) that is placed in the damaged area of the knee\n\nThe main goal is to find out if CARTISTEM® reduces knee pain and improves knee function more than debridement two years after treatment. The study will also use MRI scans to explore whether CARTISTEM® may slow the worsening of osteoarthritis over time.","conditions":["Knee Cartilage Defects"],"keywords":["symptomatic knee cartilage defects","knee cartilage","cartilage repair","osteoarthritis"],"interventions":[{"type":"BIOLOGICAL","name":"CARTISTEM® + Debridement"},{"type":"PROCEDURE","name":"Debridement"}],"enrollment":300,"startDate":"2026-03-11","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years old.\n2. Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening.\n3. Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.).\n4. Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray.\n5. Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and ≤ 9 cm2 and at least a single femoral lesion ≥ 2 cm2 as determined by independent radiologist review of study MRI.\n6. Body Mass Index (BMI) ≤ 35 kg / m2 .\n7. VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening.\n8. VAS PAIN contralateral knee score ≤ 30 based on 100-point scale at screening.\n9. WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at screening.\n10. WOMAC® Pain index knee mean score ≥ 40 to ≤ 90 based on 100-point VAS (visual analogue scale) at screening.\n11. Subjects must be willing to abstain from treatments in the index knee from the time the informed consent is signed until after the last study follow up visit.\n12. Subjects must be willing to discontinue analgesics except:\n\n    * Rescue medication (acetaminophen) allowed for break-through pain throughout the study.\n    * Subjects must be willing to discontinue use of all pain medications at least 48 hours prior to baseline assessment and each follow up visit.\n    * Limited postoperative NSAID use is permissible per IND clinical guidance and site manual, provided washout before scheduled efficacy assessments.\n    * Post operative narcotics.\n13. Subjects with stage 3 hypertension (systolic ≥ 180 mm Hg and diastolic ≥ 120 mmHg) must have blood pressure (BP) controlled prior to surgical procedure.\n14. Subject's central lab results are within normal ranges or deemed as not clinically significant by investigator for CARTISTEM® treatment or surgical comparator.\n15. Female Subjects of childbearing potential must agree to practice adequate methods of birth control to prevent pregnancy during the study.\n16. Subjects must be able to comply fully with the rehabilitation requirements.\n17. Subjects must be able to understand and comply with the requirements of the study.\n18. Subjects must voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. Subject received an IA injection of Hyaluronic Acid (HA), Platelet Rich Plasma (PRP), Bone Marrow Aspirate / Concentrate (BMA / BMAC), long-acting / conventional steroid, or investigational drug in either knee within 3 months of signing informed consent. Note: injections of the contralateral knee are allowed during the trial.\n2. Bone marrow lesion (BML) grade 3 on femur, tibia, or patella except at femoral lesion area (BML grade 3 allowed) in index knee as determined by independent radiologist review of study MRI.\n3. KL index knee grade 0, 1 or 4 as determined by independent radiologist review of study X-Ray.\n4. KL Contralateral knee severity grade 4 as determined by independent radiologist review of study X-Ray.\n5. Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist.\n6. Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or designee.\n7. Complete meniscal deficiency, meniscal root tears and / or severe meniscal extrusion as determined by independent radiologist.\n8. Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined by independent radiologist.\n9. Surgery of the index knee joint within 6 months of signing the informed consent. Investigator confirms that Subject has recovered from any prior surgical intervention to enable treatment within this study protocol. No radiation therapy of the index knee as determined by documented medical history.\n10. Chronic inflammatory articular diseases such as rheumatoid arthritis, gout, pseudogout, gouty arthritis, or fibromyalgia as determined by documented medical history.\n11. Bone disorders of index knee: osteonecrosis including avascular necrosis (AVN); Osteochondritis dissecans (OCD); Spontaneous Osteonecrosis of the Knee (SONK); Subchondral Insufficiency Fracture (SIF); Subchondral / intraosseous bone cyst \\>4mm at femoral treatment location, bone tumors, bone contusion or stress fracture, pathologic fracture, and other bone exclusionary findings as determined by independent radiologist review of study MRI or X-ray.\n12. Joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, and bone marrow infiltration as determined by independent radiologist review of study MRI or X-ray.\n13. Diseases or disorders including Paget's disease, ochronosis, acromegaly, haemochromatosis, Wilson's disease, genetic disease (hyperkinesia, etc.), or genetic collagen disorder as determined by documented medical history.\n14. Vascular or neurological disorders of the lower extremities as determined by documented medical history. Note: Varicose veins are not an exclusion criteria.\n15. Autoimmune diseases - documented medical history. Addison's Disease, Dermatomyositis, Irritable Bowel Diseases (IBD) or Irritable Bowel Syndrome (IBS) (including Crohn's disease and ulcerative colitis), Multiple sclerosis, Myasthenia gravis, Pernicious anemia, Rheumatoid Arthritis, Sjogren's Syndrome, systemic Lupus erythematosus. Note: Celiac disease is not an exclusion criterion.\n16. Subject has documented systemic diseases such as but not limited to HIV, hepatitis, HTVL, syphilis, and blood coagulopathies (including hemophilia, Von Willebrand disease, thrombocytopenia, disseminated intravascular coagulation (DIC)). Note: Occurrence of Deep Vein Thrombosis ≥ 5 years prior to consent is not an exclusion.\n17. Subject is taking anticoagulant medication (e.g., warfarin, (Coumadin), apixaban (Eliquis), rivaroxaban (Xarelto), clopidogrel (Plavix) or equivalent) but not excluding 81mg aspirin.\n18. Uncontrolled diabetes with HbA1c \\> 8% as determined by documented medical history.\n19. Infectious disease requiring parenteral administration of antibiotics.\n20. Administered immunosuppressants such as Cyclosporin A or azathioprine within 6 months of signing the informed consent.\n21. Subject has received chemotherapy in the 12 months prior to signing informed consent.\n22. Subject has received other allogeneic stem cell therapy.\n23. Prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) in the index knee or the index knee contains a uni-compartmental knee replacement. Revision of a prior microfracture procedure is allowed if subchondral plate remains intact and lesion is lacking significant intra-lesional osteophytes.\n24. Prior invasive knee osteoarthritis treatment including subchondroplasty, cryoneurolysis, genicular nerve ablation, genicular artery embolization, in situ MISHA (medial knee implanted shock absorber), prosthetic implants or other knee implants or invasive treatments for the index knee.\n25. Known history of hypersensitivity / allergy to hyaluronan.\n26. Currently pregnant or nursing.\n27. Psychotic diseases, epilepsy, or any history of such diseases.\n28. Known substance or alcohol abuse in the prior 3 years.\n29. Contraindication to MRI imaging or unwillingness to undergo MRI.\n30. Currently receiving or in litigation related to workman's compensation, personal injury, or disability claims.\n31. Considered by principal investigator inappropriate for the clinical trial due to any reasons other than those listed above.\n\nBaseline PRO Assessment Inclusion Criteria:\n\n1. VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at baseline PRO assessment.\n2. WOMAC® FUNCTION index knee mean score ≥ 25 to ≤ 90 based on 100-point scale at baseline PRO assessment.\n\nBaseline Surgical Inclusion Criteria:\n\n1\\. Treated cartilage defects Outerbridge Grade 3 or 4 in index knee with combined femoral lesion area ≤ 9 cm2 as determined arthroscopically or by arthrotomy by treating physician.\n\nBaseline Surgical Exclusion Criteria:\n\n1. Meniscal root tears and / or severe meniscal extrusion or non-functional meniscus as determined arthroscopically or by arthrotomy by treating physician.\n2. Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined arthroscopically or by arthrotomy by treating physician.\n3. Bone or joint disorders of the index knee including infection, osteomyelitis, soft tissue tumors, bone marrow infiltration, osteonecrosis (AVN or OCD) as determined arthroscopically or by arthrotomy by treating physician.\n4. Identification of prior cartilage repair procedure (such as MACI, ACI, OATS, OCA, Agili-C) or uni-compartmental knee replacement in the index knee as determined arthroscopically or by arthrotomy by treating physician. Revision of a prior microfracture procedure is allowed if subchondral bone remains intact and lacking significant intra-lesional osteophytes.\n5. Subject is documented as pregnant based on hCG urine or blood test prior to surgery.","locations":[{"facility":"Flourish Research Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottsdale Clinical Trials, LLC - Elite Clinical Network","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Orthopedic","city":"Tempe","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TriWest Research Associates","city":"El Cajon","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CORE Orthopaedic Medical Center","city":"Encinitas","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Horizon Clinical Research - La Jolla","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Horizon Clinical Research","city":"La Mesa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University - Department of Orthopaedic Surgery","city":"Redwood City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco - Orthopaedic Institute","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Source Healthcare","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orthopedic Centers of Colorado","city":"Parker","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Steamboat Orthopaedic and Spine Institute","city":"Steamboat Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research","city":"Deerfield Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sports and Orthopedic Center","city":"Deerfield Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UK Orthopaedic Surgery & Sports Medicine - Turfland","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Medical Center","city":"Kenner","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Orthopedics and Spine Surgery","city":"Rochester Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Curalta Clinical Trials","city":"Westwood","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Presbyterian Queens","city":"Flushing","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Orthopedic Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atrium Health Mercy","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Clinical Research","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Department of Orthopaedic Surgery","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Jameson Crane Sports Medicine Institute","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helios Clinical Research","city":"Jackson","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zenos Clinical Research","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hermann Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HD Research Corp.","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Futuro Clinical Trials","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Clinical Trials, P.A (ERG)","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JBR Clinical Research","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Adrian Orr, VP Clinical Development","phone":"617-575-2203","email":"cartistem2023-01@medi-post.com"},{"name":"Luis Toro, Medical Monitor for IQVIA, MD","phone":"","email":""}],"primaryOutcomes":["Visual Analog Scale (VAS) Pain Score","Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) Function score"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","scottsdale-arizona","tempe-arizona","el-cajon-california","encinitas-california","la-jolla-california","la-mesa-california","redwood-city-california","san-francisco-california","santa-monica-california","parker-colorado","steamboat-springs-colorado","deerfield-beach-florida","chicago-illinois","lexington-kentucky","kenner-louisiana","ann-arbor-michigan","rochester-hills-michigan","rochester-minnesota","omaha-nebraska","westwood-new-jersey","flushing-new-york","new-york-new-york","charlotte-north-carolina","morehead-city-north-carolina","cincinnati-ohio","columbus-ohio","jackson-tennessee","dallas-texas","houston-texas","mcallen-texas","san-antonio-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 3: testing CARTISTEM® + Debridement for Knee Cartilage Defects","inPlainEnglish":"This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis. CARTISTEM is a new treatment made of stem cells from donated umbilical cord blood mixed with a gel (hyaluronic acid) that is placed in the damaged area of the knee The main goal is to find out if CARTISTEM® reduces knee pain and improves knee function more than debridement two years after treatment.","whoItsFor":["Ages 18 Years to 75 Years","Age ≥ 18 and ≤ 75 years old","Knee Osteoarthritis diagnosed in the index knee according to the clinical definition of American College of Rheumatology (ACR) guidelines at screening","Failed conservative knee osteoarthritis treatment for at least 3 months prior to consent (weight reduction, physical therapy, injections, pain medications, etc.)","Kellgren-Lawrence (KL) in the index knee of grade 2 to 3 as determined by independent radiologist review of study X-Ray","Clinically relevant femoral cartilage defects classified using modified Outerbridge Grade 3 or 4 in index knee with combined lesion area ≥ 2 cm2 and ≤ 9 cm2 and at least a single femoral lesion ≥ 2 cm2 as determined by independent radiologist review of study MRI","Body Mass Index (body-mass index (BMI)) ≤ 35 kg / m2","VAS PAIN index knee score ≥ 40 to ≤ 90 based on 100-point scale at screening"],"whoShouldSkip":["Bone marrow lesion (BML) grade 3 on femur, tibia, or patella except at femoral lesion area (BML grade 3 allowed) in index knee as determined by independent radiologist review of study MRI","KL index knee grade 0, 1 or 4 as determined by independent radiologist review of study X-Ray","KL Contralateral knee severity grade 4 as determined by independent radiologist review of study X-Ray","Anatomical axis varus or valgus malalignment ≥ 6° in either knee as determined by independent radiologist","Joint ligament instability in index knee ≥ Grade 3 or ligament instability that would require surgical intervention as determined by investigator or designee","Complete meniscal deficiency, meniscal root tears and / or severe meniscal extrusion as determined by independent radiologist","Kissing bipolar lesions (tibial or patellar) Outerbridge 4 exceeding 25% of the femoral lesion area in size and/or penetrating through the subchondral bone as determined by independent radiologist"],"whatHappens":"If you join, the listed intervention(s) are CARTISTEM® + Debridement, or Debridement. The registry lists allocation as randomized. This study will test whether CARTISTEM is safe and works better than debridement (a surgery that cleans out damaged tissue) for people with knee cartilage damage and osteoarthritis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 37 sites. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.507Z"},{"nctId":"NCT07339774","title":"Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.","officialTitle":"Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"West China Hospital","sponsorClass":"OTHER","summary":"Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.","conditions":["Radiotherapy-induced Oral Mucositis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Placebo oral liquid and mouthwash"},{"type":"DRUG","name":"Zishui Daohuo oral liquid combined with Kujiu mouthwash"},{"type":"RADIATION","name":"Radiotherapy"}],"enrollment":128,"startDate":"2026-11-05","completionDate":"2027-05-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;\n2. Age range: 18 to 65 years old (including 18 and 65 years old);\n3. Eastern Cooperative Oncology Group performance status of ≤2;\n4. Radiotherapy or concurrent chemoradiotherapy is required;\n5. The main organ functions well;\n6. Sign informed consent.\n\nExclusion Criteria:\n\n1. Allergic constitution (such as those known to be allergic to two or more drugs);\n2. Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;\n3. Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;\n4. Poor oral hygiene and/or severe periodontal diseases;\n5. History of head and neck radiotherapy;\n6. Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).","locations":[{"facility":"West China Hospital","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xingchen Peng Professor","phone":"+8618980606753","email":"pxx2014@163.com"},{"name":"JiaYi Yu Doctor","phone":"","email":"yujiayi2209@163.com"}],"primaryOutcomes":["The duration of severe oral mucositis (RTOG grade≥3)"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["chengdu-china"],"enrichment":{"headline":"Phase 2: testing Placebo oral liquid and mouthwash for Radiotherapy-induced Oral Mucositis","inPlainEnglish":"Measure the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.","whoItsFor":["Ages 18 Years to 65 Years","Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;","Age range: 18 to 65 years old (including 18 and 65 years old);","Eastern Cooperative Oncology Group performance status of ≤2;","Radiotherapy or concurrent chemoradiotherapy is required;","The main organ functions well;"],"whoShouldSkip":["Allergic constitution (such as those known to be allergic to two or more drugs);","Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;","Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;","Poor oral hygiene and/or severe periodontal diseases;","History of head and neck radiotherapy;","Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases)"],"whatHappens":"If you join, the listed intervention(s) are Placebo oral liquid and mouthwash, Zishui Daohuo oral liquid combined with Kujiu mouthwash, or Radiotherapy. The registry lists allocation as randomized. Measure the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 128 people at Chengdu. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.341Z"},{"nctId":"NCT07342478","title":"ROCKET-CLL Global Phase 3 Study: Rocbrutinib vs Pirtobrutinib in cBTKi-Pretreated R/R CLL/SLL","officialTitle":"A Phase 3 Open-Label, Randomized, Multicenter Study of Rocbrutinib (LP-168) vs Pirtobrutinib in Covalent BTK Inhibitor (cBTKi) Pretreated Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) Subjects","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Newave Pharmaceutical Inc","sponsorClass":"INDUSTRY","summary":"This is a Phase 3, randomized, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 participants will be randomized 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met. Randomization will be stratified by presence of del(17p)/TP53 mutation (yes/no), reason for discontinuation of prior cBTKi therapy (toxicity vs disease progression), prior exposure to a BCL2 inhibitor (yes/no), and region (United States/China/rest of world). The primary endpoint is progression-free survival (PFS) assessed by an independent review committee (IRC) using iwCLL 2018 criteria for CLL and Lugano 2014 criteria for SLL. Key secondary objectives include overall survival, overall response rate, time-to-event outcomes, and safety/tolerability; exploratory objectives include health-related quality of life and biomarker assessments.","conditions":["CLL / SLL","CLL (Chronic Lymphocytic Leukemia)","CLL, Refractory","CLL, Relapsed","SLL (Small Lymphocytic Lymphoma)","SLL","CLL","CLL Progression"],"keywords":["Rocbrutinib","LP-168","Pirtobrutinib","Jaypirca","Phase 3","Randomized","Open-label","Relapsed or refractory","CLL","SLL","CLL/SLL","Chronic lymphocytic leukemia","Small lymphocytic lymphoma","Covalent BTK inhibitor pretreated","cBTKi pretreated / cBTKi-exposed","BTK inhibitor","Non-covalent BTK inhibitor","Next-generation BTKi","Dual-binding BTKi","Fourth-generation BTKi","Oral once daily","Progression-free survival","PFS","Independent review committee","IRC-assessed","iwCLL 2018","Lugano 2014","del(17p)","TP53 mutation","Prior BCL2 inhibitor exposure","eason for prior BTKi discontinuation (progression vs intolerance)","Global"],"interventions":[{"type":"DRUG","name":"Rocbrutinib"},{"type":"DRUG","name":"Pirtobrutinib"}],"enrollment":306,"startDate":"2026-04-23","completionDate":"2029-10-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years;\n* Histologically confirmed CLL/SLL iwCLL 2018;\n* Relapsed or refractory disease requiring treatment;\n* Previously treated with prior lines of therapy including a covalent BTK inhibitor;\n* Measurable disease;\n* ECOG 0-2;\n* Adequate marrow, hepatic, and renal function;\n* TP53 mutation status confirmed by NGS;\n* 17p deletion status confirmed by FISH;\n\nExclusion Criteria:\n\n* Prior ncBTKi or BTK degraders;\n* Richter's transformation;\n* Confirmed prolymphocytic leukemia;\n* Uncontrolled comorbidities or infections;\n* Known CNS involvement by CLL/SLL;\n* Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;\n* Pregnancy or breastfeeding;\n* Concomitant medications or conditions prohibited by protocol (e.g., strong drug-drug interaction risk);","locations":[{"facility":"Orchard Healthcare Research","city":"Skokie","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Center for Cancer and Blood Disorders-Bethesda","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optum Medical Group (Rhodes) P.C.","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Adult Blood and Marrow Clinic","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSU Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Associates - Spokane","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Y Chen, M.D., Ph.D.","phone":"1-206-335-3820","email":"ROCKET-CLL@newavepharma.com"},{"name":"Stephen Anthony, D.O.","phone":"1-509-847-5646","email":"ROCKET-CLL@newavepharma.com"}],"primaryOutcomes":["PFS assessed by IRC"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["skokie-illinois","bethesda-maryland","las-vegas-nevada","durham-north-carolina","columbus-ohio","pittsburgh-pennsylvania","spokane-washington"],"enrichment":{"headline":"Phase 3: testing Rocbrutinib for CLL / SLL","inPlainEnglish":"This is a Phase 3, randomly assigned, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi). Approximately 306 you would be randomly assigned 1:1 to receive rocbrutinib 200 mg orally once daily or pirtobrutinib 200 mg orally once daily, administered continuously in 28-day cycles until disease progression, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria are met.","whoItsFor":["Ages 18 Years to any","Histologically confirmed CLL/SLL iwCLL 2018;","Relapsed or refractory disease requiring treatment;","Previously treated with prior lines of therapy including a covalent BTK inhibitor;","Measurable disease;","Adequate marrow, hepatic, and renal function;","TP53 mutation status confirmed by NGS;","17p deletion status confirmed by FISH;"],"whoShouldSkip":["Prior ncBTKi or BTK degraders;","Richter's transformation;","Confirmed prolymphocytic leukemia;","Uncontrolled comorbidities or infections;","Known CNS involvement by CLL/SLL;","Prior malignancy requiring active treatment (except certain adequately treated cancers) per protocol;","Pregnancy or breastfeeding;"],"whatHappens":"If you join, the listed intervention(s) are Rocbrutinib, or Pirtobrutinib. The registry lists allocation as randomized. This is a Phase 3, randomly assigned, open-label, multicenter study comparing rocbrutinib (LP-168) versus pirtobrutinib in adult participants with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received a covalent Bruton's tyrosine kinase inhibitor (cBTKi).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 306 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.812Z"},{"nctId":"NCT07342530","title":"Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry-Guided Breathing Therapy","officialTitle":"Early Intervention for Postpartum PTSD: Comparing Written Exposure and Capnometry Guided Breathing Therapy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Stanford University","sponsorClass":"OTHER","summary":"The purpose of this study is to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.","conditions":["Written Exposure Therapy","Breathing Techniques","PTSD (Childbirth-Related)","Postpartum Care"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Written Exposure Therapy (WET)"},{"type":"DEVICE","name":"Capnometry-Guided Breathing Intervention (CGRI)"}],"enrollment":70,"startDate":"2026-03-09","completionDate":"2027-12","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18\n* Delivered a live infant within 5 days\n* Severe maternal morbidity or infant admitted to NICU\n* PCL-5 ≥28\n* English-speaking\n* Able to consent and participate\n\nExclusion Criteria:\n\n* Active psychosis or mania\n* Current suicidal crisis\n* Current suicidal intent or plan\n* Cognitive impairment preventing participation","locations":[{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Percentage of participants initiating assigned treatment","Percentage of participants completing Written Exposure Therapy (WET)","Percentage adherence to Written Exposure Therapy (WET)","Percentage of participants completing Capnometry Guided Respiratory Intervention (CGRI)","Percentage adherence to Capnometry Guided Respiratory Intervention (CGRI)","Participant Satisfaction Scale Score using Client Satisfaction Questionnaire (CSQ-8)","Treatment credibility using the Opinion About Treatment (OAT) form"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","palo-alto-california"],"enrichment":{"headline":"Not a traditional drug phase: Written Exposure Therapy (WET) for Written Exposure Therapy","inPlainEnglish":"This study wants to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.","whoItsFor":["Ages 18 Years to any","Women only","Delivered a live infant within 5 days","Severe maternal morbidity or infant admitted to NICU","Able to consent and participate"],"whoShouldSkip":["Active psychosis or mania","Current suicidal crisis","Current suicidal intent or plan","Cognitive impairment preventing participation"],"whatHappens":"If you join, the listed intervention(s) are Written Exposure Therapy (WET), or Capnometry-Guided Breathing Intervention (CGRI). The registry lists allocation as randomized. This study wants to examine two early interventions, Written Exposure Therapy and Capnometry Guided Breathing, to reduce post-traumatic stress disorder (PTSD) symptoms in women after childbirth as compared to usual care.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 70 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.411Z"},{"nctId":"NCT07342946","title":"The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome","officialTitle":"Effects of a Mediterranean Diet and Synbiotic Supplementation on Anthropometric and Biochemical Parameters and Quality of Life in Obese Women With Polycystic Ovary Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Atlas University","sponsorClass":"OTHER","summary":"This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. Participants will be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a placebo (a look-alike product with no active ingredients). All participants will follow the same reduced-calorie Mediterranean diet for 8 weeks. The study team will measure body composition and weight-related measurements, and will collect blood samples to evaluate selected laboratory markers before and after the 8-week period. Participants will also complete the PCOSQ-50 quality-of-life questionnaire before and after the intervention. The goal is to better understand the possible role of synbiotic supplementation alongside dietary treatment in PCOS.","conditions":["PCOS (Polycystic Ovary Syndrome)"],"keywords":["synbiotics","pcos","diet","nutrition"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Synbiotic Supplement"},{"type":"OTHER","name":"Placebo"}],"enrollment":32,"startDate":"2026-12-20","completionDate":"2027-04-01","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Premenopausal women who are overweight or obese, with a body mass index (BMI) between 25 and 35 kg/m²\n* Aged 18 to 45 years (reproductive age)\n* Diagnosed with polycystic ovary syndrome (PCOS)\n\nNo underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding within the past 6 months\n* Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders\n* Use of oral contraceptives\n* Following a special dietary treatment or a hypocaloric diet within the last 3 months\n* Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives\n* Participants will be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco","locations":[{"facility":"Atlas University","city":"Istanbul","state":"Istanbul","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ayşenur Emirhuseyinoglu-Calik","phone":"+905315239218","email":"ayse.emirhuseyinoglu@atlas.edu.tr"}],"primaryOutcomes":["Change in body weight","Change in body mass index (BMI)","Change in body composition","Change in waist circumference","Change in hip circumference"],"hasResults":false,"conditionSlugs":["als","obesity","pcos"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Synbiotic Supplement for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity. you would be assigned by chance (like flipping a coin) to receive either the synbiotic supplement or a dummy treatment (placebo) (a look-alike product with no active ingredients).","whoItsFor":["Ages 18 Years to 45 Years","Women only","Premenopausal women who are overweight or obese, with a body mass index (body-mass index (BMI)) between 25 and 35 kg/m²","Aged 18 to 45 years (reproductive age)","Diagnosed with polycystic ovary syndrome (PCOS)","No underlying metabolic diseases, including type 2 diabetes mellitus, hypertension, diagnosed anemia, or any other metabolic condition requiring a special diet"],"whoShouldSkip":["Pregnancy or breastfeeding within the past 6 months","Presence of comorbid conditions, including kidney, liver, or cardiovascular disease, gout, hyperuricemia, or other related disorders","Use of oral contraceptives","Following a special dietary treatment or a hypocaloric diet within the last 3 months","Occasional or current use of medications that may affect fluid balance, including diuretics and laxatives","you would be withdrawn from the study in case of abnormal biochemical parameters, non-adherence to the prescribed diet, or failure to comply with the supplementation protoco"],"whatHappens":"If you join, the listed intervention(s) are Synbiotic Supplement, or Placebo. The registry lists allocation as randomized. This study will look at whether a reduced-calorie Mediterranean-style eating plan, together with a synbiotic supplement, can improve health measures and quality of life in women who have polycystic ovary syndrome (PCOS) and are overweight or have obesity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 32 people at Istanbul. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.786Z"},{"nctId":"NCT07343869","title":"Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection","officialTitle":"Prospective Multicenter Cohort on Esophageal Submucosal Dissection: Evaluation of Technical, Oncological, and Organizational Outcomes in Real-Life Practice","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Société Française d'Endoscopie Digestive","sponsorClass":"OTHER","summary":"In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis.\n\nSurgery was historically the standard treatment for localized disease but carries significant morbidity. Over the past decade, endoscopic treatments, particularly endoscopic submucosal dissection (ESD), have become the reference approach for superficial esophageal cancers.\n\nAfter endoscopic resection, histological analysis allows classification of recurrence risk into very low, low, and high categories. Predicting lymph node or distant recurrence is complex, depending on factors such as depth of wall infiltration, lymphovascular invasion, and tumor differentiation. The frequent combination of unfavorable histological features may have led to an overestimation of lymph node involvement risk in T1b cancers.\n\nESD is widely performed in France, with over 1,600 procedures reported in 2023 for esophageal and gastric lesions, demonstrating the feasibility of a large observational study.\n\nThis multicenter French cohort will evaluate technical, oncological, and organizational outcomes of esophageal ESD, including overall survival, recurrence-free survival, and management of residual Barrett's esophagus. It will also identify predictive factors for treatment success, recurrence, and complications, providing real-world evidence to guide patient management.","conditions":["Superficial Esophageal Cancer","Oesophageal Adenocarcinoma","Oesophageal Squamous Cell Carcinoma","Barretts Esophagus With Dysplasia"],"keywords":["Endoscopic esophageal disection","Endoscopic resection","Endoscopic submucosal dissection","Curative resection"],"interventions":[],"enrollment":750,"startDate":"2026-03-11","completionDate":"2031-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (≥ 18 years old)\n* Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection\n* Patients managed in one of the participating centers\n* Patient who has received oral and written information about the study and has not objected to participation\n* Patients covered by a social security or health insurance scheme.\n\nExclusion Criteria:\n\n* Patient refusal after reading the information sheet\n* Patient under legal protection (guardianship, curatorship, court-ordered protection)\n* Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency\n* Patients previously included for another lesion in the same study\n* Pregnant or breastfeeding women.\n* Patient deprived of liberty.\n* Patient currently enrolled in another clinical trial.","locations":[{"facility":"CHU de Bordeaux - Hôpital Haut-Lévêque","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Limoges - Hôpital Dupuytren 1","city":"Limoges","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Édouard Herriot","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Nancy - Hôpital Brabois","city":"Nancy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jules Verne Clinic","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Rennes - Hôpital Pontchaillou","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Saint-Hilaire","city":"Rouen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bertrand BB BRIEAU, MD","phone":"+33650266383","email":"bertrand.brieau@gmail.com"},{"name":"Maira MORENO, PhD","phone":"+33(0)472117513","email":"rechercheclinique@sfed.org"}],"primaryOutcomes":["Recurrence-free survival according to adjuvant treatment"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bordeaux-france","limoges-france","lyon-france","nancy-france","nantes-france","rennes-france","rouen-france"],"enrichment":{"headline":"Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection","inPlainEnglish":"In France in 2018, there were an estimated 2,074 new cases of esophageal adenocarcinoma and 3,224 cases of squamous cell carcinoma. The estimated deaths from esophageal cancer were 3,725, with a standardized 5-year net survival rate of 20% for cases diagnosed between 2010 and 2015, mainly due to late diagnosis.","whoItsFor":["Ages 18 Years to any","Adults (≥ 18 years old)","Patients referred for endoscopic resection of an esophageal lesion and treated by submucosal dissection","Patients managed in one of the participating centers","Patient who has received oral and written information about the study and has not objected to participation","Patients covered by a social security or health insurance scheme"],"whoShouldSkip":["Patient refusal after reading the information sheet","Patient under legal protection (guardianship, curatorship, court-ordered protection)","Inability to inform the patient due to cognitive impairment, language barrier, or medical emergency","Patients previously included for another lesion in the same study","Pregnant or breastfeeding women","Patient deprived of liberty","Patient currently enrolled in another clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 750 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.340Z"},{"nctId":"NCT07346144","title":"Study of an AAV Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","officialTitle":"A Phase I/II Study of an AAV-1 Mediated Dual-Payload Gene Therapy in Patients With High Grade Glioma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Trogenix ltd","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and efficacy in patients with newly diagnosed or recurrent Glioblastoma.\n\nTGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response. One is herpes simplex virus thymidine kinase (HSV-tk), which converts the pro-drug valaciclovir into an active drug that can kill tumour cells and the other is interleukin 12 (IL-12), which activates the body's immune system to recognise and fight the tumour.\n\nPatients newly diagnosed with glioblastoma suitable for standard of care surgery and chemoradiotherapy or patients with recurrent glioblastoma suitable for further surgery may be eligible for the study. Patients will receive TGX-007 by a direct intratumoural injection and will then take the pro-drug valacyclovir orally for up to 21 days before proceeding to standard of care surgery.\n\nThe study is split into two phases. Phase I will treat patients at different dose levels of TGX-007 to identify the Optimal Biological Dose that will be used to further expand the study into Phase II. Phase II will expand the number of patients treated at the selected OBD to investigate how effective TGX-007 is at treating newly diagnosed and recurrent GBM.\n\nApproximately 68 people aged 18-70 will take part in the study.","conditions":["Glioblastoma (GBM)","High Grade Gliomas","Recurrent Glioblastoma","Newly Diagnosed Glioblastoma"],"keywords":["Glioblastoma","Immunotherapy","Gene Therapy","AAV","HSV-tk","IL-12","TGX-007"],"interventions":[{"type":"DRUG","name":"TGX-007"},{"type":"DRUG","name":"Valaciclovir"}],"enrollment":68,"startDate":"2026-04-21","completionDate":"2030-03","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18-70 years\n* Karnofsky performance status ≥70\n* Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI\n* Recurrent patients: First radiological progression (as determined by the multidisciplinary team \\[MDT\\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological/molecular diagnosis of GBM\n* Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)\n* Debulking surgery is indicated for optimal patient care\n* Able to swallow oral medication\n* Willing to avoid live vaccines\n* Adequate organ function\n* Female patients of childbearing potential must have a negative serum pregnancy test within 7 days prior to Day 0.\n* All patients must agree to practice true abstinence or to use highly effective contraception\n* Patient is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Patient who is pregnant, lactating or planning pregnancy during the course of the study\n* Immunodeficiency or active auto-immune disease requiring systemic therapy.\n* Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery\n* Live vaccine within 28 days prior to Day 0\n* Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0\n* History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection\n* Received previous treatment with a gene therapy\n* Significant history of a central nervous system disorder that, in the opinion of the Investigator, would preclude enrolment\n* Major surgery within 28 days prior to Day 0. A stereotactic biopsy is permitted\n* Known hypersensitivity or contraindications to valaciclovir, gadolinium, or any excipients for TGX-007\n* Contraindication to MRI with gadolinium\n* Any condition expected to interfere with the intended timing of debulking surgery\n* Previous non-glioma cancer within 3 years (other than treated squamous/basal cell skin cancer, treated early-stage cervical cancer or treated/biochemically stable, organ confined prostate cancer)\n* Any other significant disease or disorder which, in the opinion of the Investigator, may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study\n* Patients who have participated in another research study involving an investigational product in the past 12 weeks or 5 half-lives of the product\n* Any psychological, familial, sociological, or geographical consideration potentially hampering compliance with the study protocol and follow up schedule; these conditions should be discussed with the patient before registration in the study\n* Unwilling to allow their general practitioner, if appropriate, to be notified of participation in the study\n\nNewly diagnosed patients only:\n\n* Any prior therapy for glioma\n* Intended use of tumour treating fields\n\nRecurrent patients only:\n\n* Prior toxicities from anti-cancer agents or radiotherapy which have not recovered to ≤Grade 1 severity\n* Intended use of tumour treating fields","locations":[{"facility":"Ohio State University Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Infirmary of Edinburgh","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Project Management","phone":"+44131 287 5960","email":"Contact@trogenix.com"}],"primaryOutcomes":["Safety and tolerability of TGX-007 when administered to patients with newly diagnosed HGG or recurrent GBM and to identify the OBD","Overall Survival rate of patients with newly diagnosed HGG or recurrent GBM treated with TGX-007"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["columbus-ohio","edinburgh-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing TGX-007 for Glioblastoma (GBM)","inPlainEnglish":"The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and how well it works in patients with newly diagnosed or recurrent Glioblastoma. TGX-007 is a gene therapy drug delivered by a harmless adeno-associated virus (AAV) vector which delivers two combined therapeutic payloads to enable killing of proliferative cells and activation of an anti-tumour immune response.","whoItsFor":["Ages 18 Years to 70 Years","Karnofsky performance status ≥70","Newly diagnosed patients: Unifocal, unilateral high-grade glioma based on MRI","Recurrent patients: First radiological progression (as determined by the multidisciplinary team \\[MDT\\]) of GBM previously treated with standard care surgery and chemoradiotherapy. Patients must have a prior confirmed histological/molecular diagnosis of GBM","Newly diagnosed patient: suitable for six weeks of chemoradiotherapy followed by six months of adjuvant temozolomide (Stupp protocol)","Debulking surgery is indicated for optimal patient care","Able to swallow oral medication","Willing to avoid live vaccines"],"whoShouldSkip":["Patient who is pregnant, lactating or planning pregnancy during the course of the study","Immunodeficiency or active auto-immune disease requiring systemic therapy","Active viral, bacterial or fungal infection requiring concurrent antivirals or antibiotics within 7 days of surgery","Live vaccine within 28 days prior to Day 0","Use of immunosuppressant or immune modulatory medicines within 28 days prior to Day 0","History of tuberculosis infection or chest x-ray or computed tomography (CT) chest showing radiological evidence of previous tuberculosis infection","Received previous treatment with a gene therapy"],"whatHappens":"If you join, the listed intervention(s) are TGX-007, or Valaciclovir. The registry lists allocation as randomized. The goal of this clinical trial is to first define the Safety and Optimal Biological Dose (OBD) of study drug TGX-007 and to then further investigate the safety and how well it works in patients with newly diagnosed or recurrent Glioblastoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 68 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.491Z"},{"nctId":"NCT07346911","title":"Digital Interventions for Relapse Prevention in Adolescence","officialTitle":"Digital Interventions for Relapse Prevention in Adolescence","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Oslo","sponsorClass":"OTHER","summary":"Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. The purpose of this study is to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.\n\nThe study includes adolescents aged 16-19 who have previously experienced episodes of depression and/or anxiety to a degree that led them to seek help (e.g., from a school nurse, general practitioner, health clinic, or child and adolescent mental health service). Through a research app on their smartphones, participants complete tasks and answer questionnaires. The study is fully digital. Some participants meet with a therapist in digital group sessions, while others work independently with the digital content.\n\nWe will also examine the cost-benefit aspects of offering such interventions. If the study achieves its goals, digital interventions may eventually become a service offered to adolescents recovering from depression and anxiety.","conditions":["Major Depression Disorder","ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)"],"keywords":["Transdiagnostic interventions"],"interventions":[{"type":"BEHAVIORAL","name":"Transdiagnostic app intervention"},{"type":"BEHAVIORAL","name":"Transdiagnostic mastery course"}],"enrollment":495,"startDate":"2026-08-10","completionDate":"2028-02-01","sex":"ALL","minAge":"16 Years","maxAge":"19 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score \\> 65 and current t-score =\\<65.\n* Native or fluent Scandinavian language skills.\n* Willingness to take part even when allocated to the non-preferred arm of the trial.\n\nExclusion Criteria:\n\n* Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =\\<65 on RCADS-47.\n* Recent completion of one of the interventions in the two interventional arms.\n* no available smartphone.","locations":[{"facility":"University of Oslo","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ragnhild Bø, Ph.D.","phone":"+47 41904595","email":"ragnhild.bo@psykologi.uio.no"}],"primaryOutcomes":["Relapse: Number of participants scoring above the diagnostic cut-off on the PHQ-9 modified for teens during the 12-month follow-up.","Time until relapse; reaching the diagnostic criteria of MDD according to PHQ-9 modified for teens"],"hasResults":false,"conditionSlugs":["als","depression","anxiety"],"drugSlugs":[],"locationSlugs":["oslo-norway"],"enrichment":{"headline":"Not a traditional drug phase: Transdiagnostic app intervention for Major Depression Disorder","inPlainEnglish":"Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time. this study wants to examine whether digital interventions-where individuals work systematically with their own thoughts and feelings during periods when they feel well-can help them maintain well-being for longer.","whoItsFor":["Ages 16 Years to 19 Years","Currently in full or partial remission for a minimum of 2 months from a depressive disorder or an anxiety disorder as defined by self-reported scores on RCADS-47: previous episode(s) of t-score \\> 65 and current t-score =\\<65","Native or fluent Scandinavian language skills","Willingness to take part even when allocated to the non-preferred arm of the trial"],"whoShouldSkip":["Ongoing depressive disorder, ongoing anxiety disorder as defined by current t-score =\\<65 on RCADS-47","Recent completion of one of the interventions in the two treatment arms","no available smartphone"],"whatHappens":"If you join, the listed intervention(s) are Transdiagnostic app intervention, or Transdiagnostic mastery course. The registry lists allocation as randomized. Some adolescents experience periods of anxiety and/or depression, and some find that these periods return over time.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 495 people at Oslo. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.117Z"},{"nctId":"NCT07347600","title":"A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","officialTitle":"A Non-interventional Study to Evaluate the Effectiveness and Safety of Inavolisib in Patients With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (reaINAVO)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.","conditions":["Locally Advanced Breast Cancer","Metastatic Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Inavolisib"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Fulvestrant"}],"enrollment":500,"startDate":"2026-01-21","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy\n* Participants must receive the treatment of inavolisib for the first time\n* PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \\[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\\] by testing of blood or tumor tissue prior to the initiation of inavolisib\n\nExclusion Criteria:\n\n* Participants for which the treatment with inavolisib is not indicated per prescribing information. If the participant starts palbociclib and fulvestrant first, and starts inavolisib after getting a PIK3CA mutation-positive test result later, the palbociclib and fulvestrant will not be deemed as a different line of therapy. However, the medical order of PIK3CA mutation test must be made before or at the same time with the prescription of palbociclib and fulvestrant\n* Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling\n* At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study","locations":[{"facility":"The First Affiliated Hospital of Xiamen University","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Hospital of Traditional Chinese Medicine)","city":"Lanzhou","state":"Gansu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Hospital of Hebei Medical University","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wenzhou Medical University Affiliated Second Hospital","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Chongqing Medical University","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing Cancer Hospital","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen Memorial Hospital","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhujiang Hospital, Southern Medical University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial Traditional Chinese Medicine Hospital","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guizhou Provincial People's Hospital","city":"Guiyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hainan Provincial Peoples Hospital","city":"Haikou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harbin Medical University Cancer Hospital","city":"Harbin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong Provincial Hospital","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Luoyang Central Hospital","city":"Luoyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Cancer Hospital","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liaoning cancer Hospital & Institute","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Provincial Cancer Hospital","city":"Taiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province","city":"Taizhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weifang People's Hospital","city":"Weifang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xian Jiao Tong University","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Subei People's Hospital of Jiangsu province","city":"Yangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital","city":"Zhengzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan City People's Hospital","city":"Zhongshan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: ML46361 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Real-world Progression-free Survival (rwPFS)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["xiamen-china","lanzhou-china","shijiazhuang-china","changchun-china","wenzhou-china","beijing-china","chengdu-china","chongqing-china","guangzhou-china","guiyang-china","haikou-china","harbin-china","hefei-china","jinan-china","luoyang-china","nanchang-china","nanjing-china","shanghai-china","shenyang-china","taiyuan-china","taizhou-china","weifang-china","wuhan-china","xian-china","yangzhou-china","zhengzhou-china","zhongshan-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Inavolisib for Locally Advanced Breast Cancer","inPlainEnglish":"The main purpose of this study is to measure the effectiveness of inavolisib based regimen in participants with endocrine-resistant, phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha gene (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer (LA/mBC), following on or after completing adjuvant endocrine therapy in routine clinical practice in China.","whoItsFor":["Ages 18 Years to any","Participants must be diagnosed with endocrine-resistant, PIK3CA-mutated, HR+/HER2- LA/mBC, following recurrence on or after completing adjuvant endocrine therapy","Participants must receive the treatment of inavolisib for the first time","PIK3CA mutation status should be detected by a National Medical Products Administration (NMPA)-approved or validated assay \\[Polymerase Chain Reaction (PCR) or Next Generation Sequencing (NGS)\\] by testing of blood or tumor tissue prior to the initiation of inavolisib"],"whoShouldSkip":["Participants not receiving treatment for LA/mBC with inavolisib according to standard of care (SOC) and in line with the current summary of product characteristics (SPC)/local labeling","At the investigator's discretion, any reason that makes the participant hard to follow up or unsuitable to participate in the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.709Z"},{"nctId":"NCT07348484","title":"Urinary Biomarker-Based Diagnostic and Monitoring System for Chronic Kidney Disease and Real-World Effectiveness of SGLT2 Inhibitors","officialTitle":"Diagnostic and Monitoring System for Chronic Kidney Disease Based on Urinary Biomarkers and Preventive Treatment With the SGLT2 Inhibitor Empagliflozin","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Instituto de Investigación Biomédica de Salamanca","sponsorClass":"OTHER","summary":"This prospective observational study aims to assess the association between real-world use of sodium-glucose co-transporter 2 inhibitors (SGLT2i; e.g., empagliflozin, dapagliflozin) and renal function decline in adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification). The study will also validate a urinary biomarker panel for early diagnosis and monitoring of CKD progression.\n\nNo investigational product is assigned, and medical practice or prescription patterns are not altered.","conditions":["Chronic Kidney Disease"],"keywords":["SGLT2 inhibitors","empagliflozin","urinary biomarker"],"interventions":[{"type":"DRUG","name":"Empagliflozin"}],"enrollment":300,"startDate":"2026-04-01","completionDate":"2028-04","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥18 years old\n* Diagnosed with chronic kidney disease (KDIGO stages 2-4)\n* Life expectancy ≥12 months\n* Available clinical and laboratory data in the electronic medical record\n\nExclusion Criteria:\n\n* Current or recent renal replacement therapy or kidney transplantation\n* End-stage renal disease\n* Participation in interventional trials that may affect outcomes\n* Allergy or intolerance to SGLT2i (for exposed cohort)","locations":[{"facility":"Hospital Universitario de Salamanca","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carlos Martínez Salgado, PhD","phone":"+34616129633","email":"carlosms@usal.es"}],"primaryOutcomes":["Change in urinary biomarker panel expression (proteomic fingerprint)"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":["empagliflozin","dapagliflozin"],"locationSlugs":["salamanca-spain"],"enrichment":{"headline":"Not a traditional drug phase: testing Empagliflozin for Chronic Kidney Disease","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) study aims to assess the association between real-world use of sodium-glucose co-transporter 2 inhibitors (SGLT2i; e.g., empagliflozin, dapagliflozin) and renal function decline in adults with chronic kidney disease (CKD) stages 2-4 (KDIGO classification). The study will also validate a urinary biomarker panel for early diagnosis and monitoring of CKD progression.","whoItsFor":["Ages 16 Years to any","Diagnosed with chronic kidney disease (KDIGO stages 2-4)","Life expectancy ≥12 months","Available clinical and laboratory data in the electronic medical record"],"whoShouldSkip":["Current or recent renal replacement therapy or kidney transplantation","End-stage renal disease","Participation in treatment trials that may affect outcomes","Allergy or intolerance to SGLT2i (for exposed cohort)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Salamanca. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.498Z"},{"nctId":"NCT07349121","title":"OPTION-EMEA Clinical Trial","officialTitle":"Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation - Europe, Middle East and Africa [OPTION-EMEA]","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Boston Scientific Corporation","sponsorClass":"INDUSTRY","summary":"The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one interventional case.\n\nThe study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.","conditions":["Atrial Fibrillation (AF)","Stroke Prevention in Patients With Atrial Fibrillation","Left Atrial Appendage Closure","Pulsed Field Ablation","Atrial Fibrillation Ablation Procedure","Concomitant Procedures"],"keywords":["WATCHMAN","FARAPULSE","Concomitant","PFA","LAAC"],"interventions":[{"type":"DEVICE","name":"Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case"},{"type":"PROCEDURE","name":"Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure"}],"enrollment":500,"startDate":"2026-06-18","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care.\n2. Subjects who are willing and able to provide informed consent.\n3. Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center.\n4. Subjects whose age is 18 years or above, or who are of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n1. Subjects who underwent prior AF ablation procedure.\n2. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes.\n3. Already surgically closed or otherwise excluded LAA.\n4. The LAA anatomy does not accommodate a Closure Device.\n5. Known or suspected atrial myxoma.\n6. Presence of intracardiac thrombus\\*.\n7. Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device.\n8. Subjects with a presence of a mechanical valve prosthesis in any position.\n9. Subjects with a myocardial infarction within 90 days prior to enrollment.\n10. Subjects had a prior stroke (of any cause, whether ischemic or hemorrhagic) or transient ischemic attack (TIA) within 90 days prior to enrollment.\n11. Any planned electrical cardioversion within 30 days following LAAC device implant.\n12. Subjects with a known inability to obtain vascular access.\n13. Subjects with any contraindication to percutaneous catheterization procedure (e.g., patient size does not accommodate required catheters, ventriculotomy or atriotomy) or congenital abnormalities (severe rotational anomalies of the heart or great vessels) are present.\n14. Subjects with any active conditions (e.g. infection, bleeding disorder, unstable angina).\n15. Subjects with any contraindications to short term use of anticoagulation therapy for conditions different from atrial fibrillation.\n16. Subjects who are pregnant or planning to be pregnant.\n17. Subjects with a life expectancy of ≤ 1 year per investigator's opinion.\n18. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be reviewed by the sponsor to determine eligibility.","locations":[{"facility":"AZORG - Hospital","city":"Aalst","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel (AZ VUB)","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinicki bolnicki centar Zagreb","city":"Zagreb","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Cardiologique du Nord","city":"Saint-Denis","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Pasteur - Toulouse","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Cardiologico Monzino","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Policlinico San Donato","city":"San Donato Milanese","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Salamanca","city":"Salamanca","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Fe","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Alvaro Cunqueiro","city":"Vigo","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Katherine A Beattie, Sr. Clinical Trial Manager, RN","phone":"1-800-CARDIAC","email":"Katherine.beattie@bsci.com"},{"name":"Florence Defresne, Sr. Clinical Trial Manager","phone":"1-800-CARDIAC","email":"florence.defresne@bsci.com"}],"primaryOutcomes":["Primary Safety Endpoint (PSE): Device or Procedure Related Serious Adverse Events","Primary Efficacy Endpoint (PEE): Acute Treatment Success"],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["aalst-belgium","brussels-belgium","zagreb-croatia","clermont-ferrand-france","saint-denis-france","toulouse-france","milan-italy","san-donato-milanese-italy","salamanca-spain","valencia-spain","vigo-spain"],"enrichment":{"headline":"Not a traditional drug phase: Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case for Atrial Fibrillation (AF)","inPlainEnglish":"The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one treatment case. The study will include patients that are clinically indicated for atrial fibrillation (AF) ablation using the FARAPULSE PFA System and for left atrial appendage closure (LAAC) treatment using a WATCHMAN FLX Pro or WATCHMAN FLX device as part of the patient's standard of care determined by their doctor's medical judgement.","whoItsFor":["Ages 18 Years to any","Clinically indicated for treatment with both the FARAPULSE™ PFA system and with WATCHMAN FLX™ Pro or WATCHMAN FLX™ for LAAC, per physician medical judgement and as per hospitals' standard of care","Subjects who are willing and able to participate in all testing associated with this clinical study at an approved investigational center"],"whoShouldSkip":["Subjects who underwent prior AF ablation procedure","Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes","Already surgically closed or otherwise excluded LAA","The LAA anatomy does not accommodate a Closure Device","Known or suspected atrial myxoma","Presence of intracardiac thrombus\\*","Subjects with a current interatrial baffle or patch, history of atrial septal repair or has an atrial septal defect (ASD) / patent foramen ovale (PFO) device"],"whatHappens":"If you join, the listed intervention(s) are Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, or Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure. The registry lists allocation as na. The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with a WATCHMAN FLX™ Pro or WATCHMAN FLX device during one treatment case.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 500 people at 11 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.749Z"},{"nctId":"NCT07349706","title":"IMST for Dementia Risk Reduction","officialTitle":"Randomized Controlled Pilot Trial of Inspiratory Muscle Strength Training (IMST) to Reduce Dementia Risk in Older Adults","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Florida State University","sponsorClass":"OTHER","summary":"Using a 2-arm, RCT approach, the primary goal of the study is to evaluate the feasibility and preliminary efficacy of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function. Finally, investigators will assess participant adherence and acceptability ratings of using an 8-week home-based IMST protocol in a diverse older adult sample.","conditions":["Systolic Blood Pressure","Blood Pressure","Depression - Major Depressive Disorder","Anxiety","Sleep Quality","Physical Function","Cognitive Function"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Inspiratory Muscle Strength Training High-Resistance"},{"type":"DEVICE","name":"Inspiratory Muscle Strength Training Low-Resistance"}],"enrollment":30,"startDate":"2025-11-17","completionDate":"2027-02","sex":"ALL","minAge":"60 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ages 60-80\n* Converted telephone MoCA total score≥18\n* Presence of at least one dementia risk factor (e.g., MCI or subjective cognitive decline, hypertension \\[SBP \\>130 mmHg or on medication\\], sedentary lifestyle \\[\\<150 min/week\\], family history of dementia or self-reported APOE ε4 carrier, or mild sleep-disordered breathing; CAIDE total score \\[\\>5\\]\n* Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)\n* Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)\n* Optional inclusion of inspiratory muscle weakness (MIP \\<80 cmH₂O for men, \\<70 cmH₂O for women) will also be assessed.\n\nExclusion Criteria:\n\n* tMoCA \\<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)\n* Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \\> 20)\n* Unstable cardiovascular or pulmonary disease\n* Recent respiratory therapy or major medication changes\n* Self-reported severe untreated or unstable obstructive sleep apnea (OSA)\n* Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training\n* Lung and eardrum injuries\n* Non-English speaking\n* Participants with a pacemaker or other medical implants containing magnets or electronics will be noted and excluded from body composition analyses.","locations":[{"facility":"Florida State University","city":"Tallahassee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in systolic BP","Change in executive cognitive functioning"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["tallahassee-florida"],"enrichment":{"headline":"Not a traditional drug phase: Inspiratory Muscle Strength Training High-Resistance for Systolic Blood Pressure","inPlainEnglish":"Using a 2-arm, RCT approach, the primary goal of the study is to measure the feasibility and preliminary how well it works of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults. Next, investigators will examine secondary effects of IMST on mood, sleep quality, systemic inflammation, and physical/motor function.","whoItsFor":["Ages 60 Years to 80 Years","Converted telephone MoCA total score≥18","Capable of independently completing or requiring minimal assistance with inspiratory muscle strength training (IMST)","Willing to adhere to the IMST protocol (approximately 5-10 minutes per day for 8 weeks)","Optional inclusion of inspiratory muscle weakness (MIP \\<80 cmH₂O for men, \\<70 cmH₂O for women) will also be assessed"],"whoShouldSkip":["tMoCA \\<18, or diagnosis of neurodegenerative illness at the discretion of principal investigator (except MCI)","Current evidence of any major psychiatric disorder including psychosis (at the discretion of principal investigator), bipolar disorder, severe major depression (PHQ-9 \\> 20)","Unstable cardiovascular or pulmonary disease","Recent respiratory therapy or major medication changes","Self-reported severe untreated or unstable obstructive sleep apnea (OSA)","Recent start (within the past month) of CPAP or BiPAP, or recent use of inspiratory muscle training","Lung and eardrum injuries"],"whatHappens":"If you join, the listed intervention(s) are Inspiratory Muscle Strength Training High-Resistance, or Inspiratory Muscle Strength Training Low-Resistance. The registry lists allocation as randomized. Using a 2-arm, RCT approach, the primary goal of the study is to measure the feasibility and preliminary how well it works of Inspiratory Muscle Strength Training (IMST) as a non-pharmacologic intervention to reduce cardiovascular and cognitive risks in older adults.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Tallahassee. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.120Z"},{"nctId":"NCT07349940","title":"Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care","officialTitle":"Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institute of Health Information and Statistics of the Czech Republic","sponsorClass":"OTHER_GOV","summary":"The project is a national, prospective, multicenter, single-arm interventional pilot of screening skin tumors in the Czech Republic.\n\nThe primary aim of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of skin tumors by using a telemedicine tools and setting up and testing new methods and implementation into the system of social health care.","conditions":["Skin Cancer Prevention","Melanoma In Situ","Skin Lesions","Skin Cancer","Mole (Dermatology)"],"keywords":["skin cancer","melanoma","telemedicine tool","skin tumors"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Intervention with telemedicine tool"}],"enrollment":1440,"startDate":"2026-02-01","completionDate":"2026-08-31","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* at least 1 suspected lession\n* phototype I or phototype II\n\nExclusion Criteria:\n\n* skin lession examination by dermatologist in last 12 months\n* unsigned consent to participate in the project and consent to the processing of personal data","locations":[{"facility":"St. Anne's University Hospital Brno","city":"Brno","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Olomouc University Hospital","city":"Olomouc","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Pilsen","city":"Pilsen","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bulovka University Hospital","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University hospital Kralovske Vinohrady","city":"Prague","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dagmar Obšilová, Msc","phone":"+420606429382","email":"dagmar.obsilova@uzis.cz"},{"name":"Lucie Mandelova, Ph.D.","phone":"+420 770190 828","email":"lucie.mandelova@uzis.cz"}],"primaryOutcomes":["Potential malignancies","Confirmed malignancies","Confirmed malignancies by histology"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["brno-czechia","olomouc-czechia","pilsen-czechia","prague-czechia"],"enrichment":{"headline":"Not a traditional drug phase: Intervention with telemedicine tool for Skin Cancer Prevention","inPlainEnglish":"The project is a national, prospective, multicenter, single-arm treatment pilot of screening skin tumors in the Czech Republic. The primary aim of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of skin tumors by using a telemedicine tools and setting up and testing new methods and implementation into the system of social health care.","whoItsFor":["Ages 50 Years to any","at least 1 suspected lession","phototype I or phototype II"],"whoShouldSkip":["skin lession examination by dermatologist in last 12 months","unsigned consent to participate in the project and consent to the processing of personal data"],"whatHappens":"If you join, the listed intervention(s) are Intervention with telemedicine tool. The registry lists allocation as na. The project is a national, prospective, multicenter, single-arm treatment pilot of screening skin tumors in the Czech Republic.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,440 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.807Z"},{"nctId":"NCT07350551","title":"Pediatric Epilepsy","officialTitle":"Pediatric Epilepsy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Texas Southwestern Medical Center","sponsorClass":"OTHER","summary":"The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, making decisions or choices about presented information and self-control. These investigations are critical to better understand human cognition and to design treatments for disorders of learning, memory, decision making and cognitive control.","conditions":["Epilepsy Intractable"],"keywords":["Epilepsy","Decision-making","Cognitive control","Memory","Depth Electrode","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","ADHD (Attention-Deficit/Hyperactivity Disorder)","Cognitive development"],"interventions":[{"type":"BEHAVIORAL","name":"Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator"}],"enrollment":200,"startDate":"2026-07-01","completionDate":"2031-12","sex":"ALL","minAge":"3 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Candidates will be those who are admitted to the Epilepsy Monitoring Unit and are able to participate in a pre-operative evaluation using depth intracranial electrodes. The candidacy is determined independently by the patient's treating physician as part of the patient's routine medical care.\n* Patients have drug-intractable epilepsy undergoing invasive monitoring in the EMU.\n\nExclusion Criteria:\n\n* Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain.","locations":[{"facility":"Children's Medical Center Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tashinga Mupambo","phone":"214-645-1355","email":"Tashinga.Mupambo@UTSouthwestern.edu"},{"name":"Zhongzheng Fu","phone":"214-648-3884","email":"zhongzheng.fu@utsouthwestern.edu"}],"primaryOutcomes":["Intracranial electroencephalography (iEEG) power in the theta band","iEEG high-gamma activity","iEEG theta-gamma phase-amplitude coupling","Decision-making (firing rates)","Behavioral accuracy (neuromodulation)","Reaction times (neuromodulation)","Firing rate (neuromodulation)"],"hasResults":false,"conditionSlugs":["epilepsy","adhd"],"drugSlugs":[],"locationSlugs":["dallas-texas"],"enrichment":{"headline":"Not a traditional drug phase: Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator for Epilepsy Intractable","inPlainEnglish":"The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, making decisions or choices about presented information and self-control. These investigations are critical to better understand human cognition and to design treatments for disorders of learning, memory, decision making and cognitive control.","whoItsFor":["Ages 3 Years to 25 Years","Patients have drug-intractable epilepsy undergoing invasive monitoring in the EMU"],"whoShouldSkip":["Determination by clinicians and investigators that a patient is unable to complete the behavioral tasks required for the protocol due to either cognitive limits, psychological limits, or pain"],"whatHappens":"If you join, the listed intervention(s) are Cedrus RB series response pad; Adtech Behnke-Fried micro-electrodes; Neuralynx or Blackrock electrophysiology system; Blackrock Cerestim or Natus Nicolet stimulator. The registry lists allocation as na. The purpose of the research is to better understand how the human brain accomplishes the basic cognitive tasks of learning new information, recalling stored information, making decisions or choices about presented information and self-control.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Dallas. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.655Z"},{"nctId":"NCT07351045","title":"A Clinical Study to Evaluate the Effects of Enicepatide (RO7795068) in Participants With Obesity or Overweight Without Type 2 Diabetes","officialTitle":"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight Without Type 2 Diabetes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with placebo for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.","conditions":["Obesity or Overweight"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Placebo"},{"type":"COMBINATION_PRODUCT","name":"Enicepatide"}],"enrollment":2000,"startDate":"2026-03-16","completionDate":"2028-07-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have at screening:\n\n  1. Body mass index (BMI) greater than or equal to (≥)30.0 kg/m\\^2; or\n  2. BMI ≥27.0 kg/m\\^2 and \\<30.0 kg/m\\^2 with at least one weight-related comorbidity, such as prediabetes, hypertension, dyslipidemia, diagnosis of obstructive sleep apnea, or weight-related cardiovascular disease\n* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight\n* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM) or T2DM, or history of ketoacidosis or hyperosmolar state/coma. Prior, but not current, diagnosis of gestational diabetes is allowed if no history of diabetes is recorded since.\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening\n* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)\n* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.\n* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)\n* History of acute or chronic pancreatitis or clinically significant gallbladder disease. History of acute pancreatitis caused by gallstones or clinically significant gallbladder disease is allowed if the participant had a cholecystectomy to resolve the problem at least 3 months prior to screening.\n* Poorly controlled hypertension at screening\n* Any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure.\n* Have a history of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, or other serious mood or anxiety disorder). Participants with MDD or generalized anxiety disorder whose disease state is considered stable within 1 year prior to screening and expected to remain stable throughout the course of the study, in the opinion of the investigator, are allowed provided that they are not receiving prohibited medication.\n* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization","locations":[{"facility":"Pinnacle Research Group","city":"Anniston","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alabama Clinical Therapeutics","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Clinical Trials","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research, LLC","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rophe Adult and Pediatric Medicine/SKYCRNG","city":"Union City","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"East-West Medical Research Institute","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elevate Clinical Research","city":"Gurnee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knownwell","city":"Schaumburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health","city":"Skokie","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension DePaul Health","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baltimore VA Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University School of Nursing","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knownwell","city":"Needham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"International Diabetes Center At Park Nicollet","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research at Gulfport Memorial","city":"Gulfport","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinvest Research LLC","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hometown Urgent Care and Research - 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This study wants to assess the how well it works and safety of enicepatide, a dual glucagon like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with dummy treatment (placebo) for weight management in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,000 people at 209 sites. 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Centre","city":"Blackpool","state":"Lancashire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aberdeen Royal Infirmary","city":"Aberdeen","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antrim Area Hospital","city":"Antrim","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southmead General Hospital","city":"Bristol","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ninewells Hospital and Medical School - Tayside Health Board","city":"Dundee","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"HMC Health Group","city":"Hounslow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hull Royal Infirmary","city":"Hull","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"George Eliot Hospital","city":"Nuneaton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Knowle House Surgery","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Musgrove Park Hospital","city":"Taunton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: WC45726 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percent (%) Change from Baseline in Body Weight at Week 72"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["guntersville-alabama","tucson-arizona","irvine-california","lake-forest-california","long-beach-california","montclair-california","norco-california","rancho-cucamonga-california","spring-valley-california","washington-d-c-district-of-columbia","clearwater-florida","pembroke-pines-florida","port-orange-florida","st-petersburg-florida","columbus-georgia","decatur-georgia","union-city-georgia","blackfoot-idaho","springfield-illinois","lake-charles-louisiana","metairie-louisiana","new-orleans-louisiana","columbia-maryland","olive-branch-mississippi","kansas-city-missouri","morehead-city-north-carolina","winston-salem-north-carolina","columbus-ohio","norman-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","pittsburgh-pennsylvania","north-charleston-south-carolina","sioux-falls-south-dakota","brownsville-texas","dallas-texas","edinburg-texas","houston-texas","pasadena-texas","san-antonio-texas","tomball-texas","manassas-virginia","suffolk-virginia","redmond-washington","buenos-aires-argentina","ciudad-autonoma-buenos-aires-argentina","mar-del-plata-argentina","blacktown-australia","camperdown-australia","meadowbrook-australia","oaklands-park-australia","heidelberg-australia","melbourne-australia","goi-nia-brazil","porto-alegre-brazil","aracaju-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","rio-de-janeiro-brazil","calgary-canada","vancouver-canada","brampton-canada","greater-sudbury-canada","toronto-canada","montreal-canada","sherbrooke-canada","qu-bec-canada","cangzhou-china","kaifeng-china","xuzhou-china","zhenjiang-china","xianyang-china","jinan-china","ningbo-china","beijing-china","changchun-china","hefei-china","herbin-china","huizhou-china","langfang-china","luoyang-china","nanjing-china","pingxiang-china","shanghai-china","siping-china","suzhou-china","wuxi-china","xian-china","yueyang-china","brand-s-nad-labem-czechia","jesenice-czechia","prague-czechia","praha-9-kl-novice-czechia","lyon-france","marseille-france","nice-france","paris-france","tours-france","bad-oeynhausen-germany","erlangen-germany","essen-germany","frankfurt-germany","gelnhausen-germany","hamburg-germany","hof-germany","k-ln-d-nnwald-germany","m-nster-germany","pirna-germany","ahmedabad-india","trivandrum-india","indore-india","mumbai-india","pune-india","chennai-india","hyderabad-india","bergamo-italy","catanzaro-italy","bologna-italy","rome-italy","milan-italy","palermo-italy","perugia-italy","aichi-japan","fukuoka-japan","hokkaido-japan","osaka-japan","tokyo-japan","col-saucito-mexico","guadalajara-mexico","m-xico-mexico","delegacion-cuauhtemoc-mexico","cuernavaca-mexico","san-pedro-garza-garc-a-mexico","ciudad-madero-mexico","bialystok-poland","bydgoszcz-poland","d-bica-poland","lublin-poland","pabianice-poland","poznan-poland","ruda-l-ska-poland","siedlce-poland","warsaw-poland","wroclaw-poland","san-juan-puerto-rico","cluj-napoca-romania","ploie-ti-romania","craiova-romania","ia-i-romania","timi-oara-romania","seongnam-si-south-korea","daejeon-south-korea","gangwon-do-south-korea","gwangju-south-korea","gyeonggi-do-south-korea","seoul-south-korea","badalona-spain","a-coru-a-spain","ferrol-spain","pozuelo-de-alarc-n-spain","barcelona-spain","madrid-spain","m-laga-spain","seville-spain","changhua-taiwan","chiayi-city-taiwan","kaohsiung-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","bangkok-thailand","chiang-mai-thailand","hat-yai-thailand","khlong-luang-thailand","istanbul-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","izmir-turkey-t-rkiye","sari-am-turkey-t-rkiye","blackpool-united-kingdom","aberdeen-united-kingdom","antrim-united-kingdom","bristol-united-kingdom","dundee-united-kingdom","hounslow-united-kingdom","hull-united-kingdom","nuneaton-united-kingdom","plymouth-united-kingdom","taunton-united-kingdom"],"enrichment":{"headline":"Phase 3: Placebo for Obesity or Overweight","inPlainEnglish":"This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with dummy treatment (placebo) for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).","whoItsFor":["Ages 18 Years to any","Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)","Body mass index (body-mass index (BMI)) ≥27.0 kg/m\\^2","History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight"],"whoShouldSkip":["History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening","Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening","At least 2 confirmed fasting blood glucose values \\>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening","Self-reported change in body weight \\>5 kg within 3 months prior to screening","Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)","Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed","Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)"],"whatHappens":"If you join, the listed intervention(s) are Placebo, or Enicepatide. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA), at multiple doses compared with dummy treatment (placebo) for weight management in participants with obesity or overweight and Type 2 diabetes mellitus (T2DM).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,600 people at 222 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.520Z"},{"nctId":"NCT07351643","title":"CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome","officialTitle":"Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Patients With Stage 4 CKM Syndrome Using Photon-counting CT","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Shenyang Northern Hospital","sponsorClass":"OTHER","summary":"The aim of this clinical trial is to investigate whether dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.\n\nCoronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.\n\nThe main questions it aims to answer are\n\n* Does dapagliflozin lower coronary artery inflammation as measured by FAI?\n* Does dapagliflozin slow the progression of coronary plaques?\n\nResearchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.\n\nParticipants will:\n\n* Undergo percutaneous coronary intervention (PCI) for ACS\n* Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone.\n* Have a follow-up CCTA scan at 6 months after randomisation.\n* Receive follow-up phone calls at 3 and 6 months after randomisation","conditions":["ACS (Acute Coronary Syndrome)","SGLT2 Inhibitors"],"keywords":["Fat attenuation index","SGLT2 inhibitors","Pericoronary adipose tissue","Residual inflammatory risk","Coronary CT angiography"],"interventions":[{"type":"DRUG","name":"Dapagliflozin"}],"enrollment":110,"startDate":"2026-06-25","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Aged ≥ 18 years, irrespective of gender;\n2. Meeting the diagnostic criteria for stage 4 CKM syndrome;\n3. Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;\n4. Signed informed consent form.\n\nExclusion Criteria\n\n1. Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;\n2. Severe hepatic dysfunction (Child-Pugh class C);\n3. History of recurrent urogenital tract infections;\n4. History of allergy or intolerance to SGLT2 inhibitors;\n5. Pregnant or lactating women;\n6. Systolic blood pressure \\< 90 mmHg and/or diastolic blood pressure \\< 60 mmHg;\n7. Severe chronic kidney disease (eGFR \\< 30 mL/min/1.73 m²);\n8. Participation in other interventional clinical trials;\n9. Other conditions deemed inappropriate for enrolment by the investigator(s).","locations":[{"facility":"General Hospital of Northern Theater Command","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Changes in FAI from baseline to 6 months in patients assessed by CCTA"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dapagliflozin"],"locationSlugs":["shenyang-china"],"enrichment":{"headline":"Phase 4: testing Dapagliflozin for ACS (Acute Coronary Syndrome)","inPlainEnglish":"The aim of this clinical trial is to see if dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome. Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.","whoItsFor":["Ages 18 Years to any","Aged ≥ 18 years, irrespective of gender;","Meeting the diagnostic criteria for stage 4 CKM syndrome;","Able to cooperate with photon-counting CT examination during the index hospitalisation, with no contraindications to the examination;"],"whoShouldSkip":["Receiving SGLT2 inhibitor therapy within 4 weeks prior to enrolment;","Severe hepatic dysfunction (Child-Pugh class C);","History of recurrent urogenital tract infections;","History of allergy or intolerance to SGLT2 inhibitors;","Pregnant or lactating women;","Systolic blood pressure \\< 90 mmHg and/or diastolic blood pressure \\< 60 mmHg;","Severe chronic kidney disease (eGFR \\< 30 mL/min/1.73 m²);"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin. The registry lists allocation as randomized. The aim of this clinical trial is to see if dapagliflozin (a sodium-glucose cotransporter 2 inhibitor, SGLT2i) can reduce levels of coronary inflammation in patients with stage 4 CKM syndrome.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 110 people at Shenyang. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.947Z"},{"nctId":"NCT07352306","title":"Topical Diacerein in Psoriasis Vulgaris","officialTitle":"The Efficacy of Topical Diacerein Cream in Patients With Psoriasis Vulgaris","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Alaa Ashraf Muhammad Helal","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the safety and effectiveness of topical diacerein in adults with psoriasis vulgaris. The primary objective of the study is to compare the proportion of participants who achieve a clinically meaningful improvement in disease severity between the topical diacerein group and the placebo group.\n\nParticipants will:\n\nBe assigned to receive topical diacerein 1% or placebo twice daily for a treatment period of 2 months.\n\nAttend follow-up visits at Weeks 2, 4, 6, and 8. Undergo an additional evaluation one month after treatment cessation.","conditions":["Psoriasis Vulgaris"],"keywords":["Diacerein","Psoriasis vulgaris","Topical","Interleukin-1β inhibitor","Randomized controlled trial"],"interventions":[{"type":"DRUG","name":"Diacerein"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2026-04-11","completionDate":"2027-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years old of both genders.\n* Patients with mild chronic plaque psoriasis body surface area (BSA \\< 10%) along with Psoriasis Area and Severity Index (PASI) score of \\< 10, and/or Dermatology Life Quality Index (DLQI) score of \\<10.\n\nExclusion Criteria:\n\n* Documented hypersensitivity or idiosyncratic reaction to the investigational product or any excipients contained within the cream formulation.\n* Intake of anti-psoriatic systemic therapy within the last 3 months, or topical treatments within the last 2 weeks.\n* Patients with pustular psoriasis.\n* Pregnant and breast-feeding individuals.\n* Patients with psoriatic arthritis.","locations":[{"facility":"Kasr Al-Ainy Psoriasis Unit","city":"Cairo","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alaa A Helal, BSc in Pharmacy","phone":"1124438381","email":"alaa.ashraf.muhammad@std.pharma.cu.edu.eg"}],"primaryOutcomes":["Proportion of Participants Achieving PASI 75"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["cairo-egypt"],"enrichment":{"headline":"Phase 4: testing Diacerein for Psoriasis Vulgaris","inPlainEnglish":"The goal of this clinical trial is to measure the safety and effectiveness of topical diacerein in adults with psoriasis vulgaris. The primary objective of the study is to compare the proportion of participants who achieve a clinically meaningful improvement in disease severity between the topical diacerein group and the dummy treatment (placebo) group.","whoItsFor":["Ages 18 Years to any","Age ≥18 years old of both genders","Patients with mild chronic plaque psoriasis body surface area (BSA \\< 10%) along with Psoriasis Area and Severity Index (PASI) score of \\< 10, and/or Dermatology Life Quality Index (DLQI) score of \\<10"],"whoShouldSkip":["Documented hypersensitivity or idiosyncratic reaction to the investigational product or any excipients contained within the cream formulation","Intake of anti-psoriatic systemic therapy within the last 3 months, or topical treatments within the last 2 weeks","Patients with pustular psoriasis","Pregnant and breast-feeding individuals","Patients with psoriatic arthritis"],"whatHappens":"If you join, the listed intervention(s) are Diacerein, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to measure the safety and effectiveness of topical diacerein in adults with psoriasis vulgaris.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 60 people at Cairo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.585Z"},{"nctId":"NCT07353216","title":"Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels","officialTitle":"Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels：A Multicenter, Open-Label, Observational Real-World Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Third Affiliated Hospital, Sun Yat-Sen University","sponsorClass":"OTHER","summary":"Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections . Pathologically, MS presents as multiple demyelinating lesions in the CNS, which may be accompanied by damage to nerve cells and their axons. Lesions on MRI show characteristic distributions, morphologies, and signal intensities . MS typically onset in young adults and is more common in women. Frequent symptoms include visual decline, diplopia, limb sensory disturbances, limb motor impairment, ataxia, and bladder or rectal dysfunction . As MS can lead to varying degrees of neurological deficits, and repeated relapses result in disability progression, it impacts patients' normal lives and work, posing a significant burden on individuals, families, and society. Considerable progress has been made in MS treatment in recent years, with agents such as teriflunomide, fingolimod, siponimod, and dimethyl fumarate having been approved for marketing in China.\n\nIn the two concurrently conducted active-comparator trials, ASCLEPIOS I and II, involving patients with relapsing multiple sclerosis, the annualized relapse rate was significantly lower in the ofatumumab group compared to the teriflunomide group. Ofatumumab was also superior to teriflunomide in suppressing MRI lesion activity . Although the aforementioned studies have confirmed the clinical efficacy of ofatumumab in treating MS, data from Chinese populations are lacking. Its clinical effectiveness, safety, and optimal treatment timing require further support from real-world evidence.\n\nExploring more indicators to predict MS disease activity and progression is crucial for identifying high-risk patients, assessing prognosis, and evaluating treatment response. Neurofilament light chain (NfL) is a specific biomarker for neuroaxonal damage, released into the cerebrospinal fluid (CSF) and serum after axonal injury . Serum and CSF NfL concentrations are highly correlated. Numerous studies in recent years have shown that high sNfL levels are associated with active T2 lesions and relapses, as well as brain volume loss. sNfL can not only monitor disease activity and treatment response at the group level in MS patients but also predict disease course, making it a valuable biomarker for predicting MS relapses and disability progression. It helps identify patients at higher risk of future disease activity and assists in clinical decision-making. Previous data from ASCLEPIOS I and II demonstrated that ofatumumab significantly reduced sNfL concentrations at the first assessment (Month 3) and at all subsequent visits in patients with RMS . However, existing studies have not included data from Chinese populations. This study aims to address this data gap for this specific population.","conditions":["Multiple Sclerosis"],"keywords":["NfL, Multiple sclerosis, treatment"],"interventions":[{"type":"DRUG","name":"Ofatumumab"}],"enrollment":80,"startDate":"2023-12-01","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:Signed and dated informed consent must be obtained before participation in the study.\n\nAny gender, aged at least 18 years at the time of study enrollment (signing the informed consent form).\n\nPatients with RMS meeting the 2017 Revised McDonald Criteria. EDSS score between 0 and 7. Regular follow-up with MRI monitoring. Willingness to provide blood samples. Willingness to undergo clinical assessments (including scales and physical examinations).\n\n\\-\n\nExclusion Criteria:Decision by the subject/legal guardian . Pregnancy. Diagnosis of Progressive Multifocal Leukoencephalopathy (PML). Hypersensitivity reaction to the investigational drug. Protocol violation that poses a significant safety risk to the subject. Occurrence of certain adverse events, such as malignancy, hepatic failure, or severe chronic infections (e.g., active hepatitis B, HIV).\n\nAny laboratory abnormality that, considering the subject's overall condition, is deemed to prevent the subject's continued participation in the study.\n\nAny condition that may pose a safety risk due to participation in the study. Non-compliance with the administration of the investigational drug or study procedures\n\n\\-","locations":[{"facility":"The Third Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Qiu Ph.D","phone":"+8615899968330","email":"qiuwei120@vip.163.com"}],"primaryOutcomes":["Ofatumumab treatment reduces sNfL levels in patients with Relapsing Multiple Sclerosis"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":["ofatumumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Ofatumumab for Multiple Sclerosis","inPlainEnglish":"Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections .","whoItsFor":["Ages 18 Years to any","Patients with RMS meeting the 2017 Revised McDonald Criteria. EDSS score between 0 and 7. Regular follow-up with MRI monitoring. Willingness to provide blood samples. Willingness to undergo clinical assessments (including scales and physical examinations)"],"whoShouldSkip":["Any laboratory abnormality that, considering the subject's overall condition, is deemed to prevent the subject's continued participation in the study","Any condition that may pose a safety risk due to participation in the study. Non-compliance with the administration of the investigational drug or study procedures"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 80 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.277Z"},{"nctId":"NCT07353931","title":"Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight","officialTitle":"A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Osteoarthritis Knee Pain, and Obesity or Overweight (ENLIGHTEN-4)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. 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Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain.","whoItsFor":["Ages 18 Years to any","Have a body mass index (body-mass index (BMI)) of 27 kilograms per square meter (kg/m²) or higher at screening","Have a stable body weight (less than 5% body weight change) for 90 days prior to screening","Have tried at least once to lose weight through diet but were unsuccessful","Have osteoarthritis of the knee and at least one of the following conditions:","Be over 50 years old","Have morning knee stiffness that lasts about 30 minutes","Have a crackling or grinding sound or feeling in the knee"],"whoShouldSkip":["Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)","Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)","Have type 1 diabetes, type 2 diabetes, or any other type of diabetes","Have an active knee infection","Have had within 90 days prior to screening:","coronary artery revascularization","unstable angina, or"],"whatHappens":"If you join, the listed intervention(s) are Eloralintide, or Placebo. The registry lists allocation as randomized. The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 900 people at 147 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.519Z"},{"nctId":"NCT07354074","title":"Study to Determine the Efficacy and Safety of Asciminib in Pediatric Patients With Ph+ CML-CP","officialTitle":"A Phase II, Multicenter, Open-label, Single Arm Study to Evaluate the Safety and Efficacy of Asciminib in Pediatric Participants Newly Diagnosed or Previously Treated With Philadelphia Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) With or Without Known T315I Mutation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The aim of this study is to support development of asciminib in the pediatric population (1 to \\< 18 years) with Ph+ CML-CP. The study will evaluate the efficacy and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.","conditions":["Chronic Myelogenous Leukemia","Leukemia, Myelogenous, Chronic, Philadelphia Chromosome Positive"],"keywords":["Asciminib","ABL001","Pediatric participants","Philadelphia chromosome positive chronic myeloid leukemia in chronic phase","Ph+ CML-CP","tyrosine kinase inhibitor","TKI","Molecular Response","MR","CML","Chronic phase","T3151","Ph+"],"interventions":[{"type":"DRUG","name":"Asciminib single agent"}],"enrollment":50,"startDate":"2026-04-28","completionDate":"2033-02-23","sex":"ALL","minAge":"1 Year","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria:\n\n1. Signed informed consent must be obtained prior to participation in the study.\n2. Male or female participants 1 and \\< 18 years of age at study enrollment\n3. Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome\n4. For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:\n\n   1. Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:\n\n      * At three months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS (if confirmed within 1-3 months)\n      * At six months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS\n      * At twelve months after initiation of therapy: BCR::ABL1 ratio \\> 1% IS\n      * At any time loss of previous response\n      * At any time emergent resistant BCR::ABL1 mutations or high-risk ACA from prior TKI treatment as per local test results\n   2. Intolerance to TKI is defined as:\n\n      * Non-hematologic intolerance: participants with grade 3 or 4 toxicity while on therapy (in which case the patient is eligible whether or not there was a dose reduction); or with persistent grade 2 toxicity unresponsive to optimal management including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal)\n      * Hematologic intolerance: participants with grade 3 or 4 toxicity (absolute neutrophil count \\[ANC\\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses of the TKI\n\n6\\. Evidence of typical BCR::ABL1 transcript \\[e14a2 and/or e13a2\\] at the time of screening which are amenable to standardized RQ-PCR quantification.\n\n7\\. Performance status: Karnofsky ≥ 50% for participants ≥ 16 years of age, and Lansky ≥ 50 for participants \\< 16 years of age at the time of screening.\n\nKey Exclusion Criteria:\n\n1. Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)/Blast Phase (BP).\n2. Previous treatment with a hematopoietic stem-cell transplantation.\n3. Patient planned to undergo allogeneic hematopoietic stem cell transplantation\n4. Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry\n\nOther inclusion/exclusion criteria may apply.","locations":[{"facility":"Ann and Robert H Lurie Childs Hosp","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center New York Presbyterian","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cinn Children Hosp Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Childrens Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"North Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Rio de Janeiro","state":"Rio de Janeiro","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative 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48"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["chicago-illinois","new-brunswick-new-jersey","new-york-new-york","cincinnati-ohio","seattle-washington","brisbane-australia","north-adelaide-australia","rio-de-janeiro-brazil","barretos-brazil","s-o-paulo-brazil","edmonton-canada","montreal-canada","zhengzhou-china","tianjin-china","marseille-france","paris-france","poitiers-france","strasbourg-france","frankfurt-am-main-germany","erlangen-germany","hamburg-germany","debrecen-hungary","padova-italy","roma-italy","yokohama-japan","fukuoka-japan","saitama-japan","utrecht-netherlands","gdansk-poland","wroclaw-poland","singapore-singapore","seoul-south-korea","barcelona-spain","madrid-spain","bangkok-thailand","hanoi-vietnam"],"enrichment":{"headline":"Phase 2: testing Asciminib single agent for Chronic Myelogenous Leukemia","inPlainEnglish":"The aim of this study is to support development of asciminib in the pediatric population (1 to \\< 18 years) with Ph+ CML-CP. The study will measure the how well it works and safety of asciminib in pediatric formulation (weigh-based dose, fed state) or adult formulation (fasted) in newly diagnosed and resistant or intolerant Ph+ CML-CP with or without T315I mutation.","whoItsFor":["Ages 1 Year to 18 Years","Participants eligible for inclusion in this study must meet all of the following criteria:","Male or female participants 1 and \\< 18 years of age at study enrollment","Diagnosis of CML-CP (Apperley et al 2025) with cytogenetic confirmation of Philadelphia positive (Ph+) chromosome","For participants with CML-CP newly diagnosed within 3 months of screening OR 5 For participants with CML - CP with high risk of developing resistance or intolerance to previous TKI:","Unfavourable response to TKI is defined following the Apperley et al 2025 guidelines as:","At three months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS (if confirmed within 1-3 months)","At six months after the initiation of therapy: BCR::ABL1 ratio \\> 10% IS"],"whoShouldSkip":["Known second chronic phase (CP) of CML after previous progression to Accelerated Phase (AP)/Blast Phase (BP)","Previous treatment with a hematopoietic stem-cell transplantation","Patient planned to undergo allogeneic hematopoietic stem cell transplantation","Known presence of a BCR::ABL1 mutation with known resistance to study treatment in accordance with the most recent public version of international CML clinical guidelines (e.g. NCCN CML treatment guidelines v 1.2026 and Apperley et al 2025) any time prior to study entry"],"whatHappens":"If you join, the listed intervention(s) are Asciminib single agent. The registry lists allocation as na. The aim of this study is to support development of asciminib in the pediatric population (1 to \\< 18 years) with Ph+ CML-CP.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at 36 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.730Z"},{"nctId":"NCT07355218","title":"A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)","officialTitle":"A Phase 3, Randomized, Double-Blind,Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants With Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care (ELOWEN-2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"EMD Serono Research & Development Institute, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this global, multicenter, Phase 3 study is to evaluate the efficacy and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include:\n\nStudy Duration: Up to 35 weeks. Treatment Duration: 24 weeks. Visit Frequency: every 4 weeks, with the exception of the Week 2 televisit. Study Intervention Name: Enpatoran, Placebo.\n\nIntervention Form: Film-coated tablet.","conditions":["Systematic Lupus Erythematosus","Cutaneous Lupus Erythematosus"],"keywords":["Toll-like Receptor 7","Toll-like Receptor 8","Adults","SLE","CLE","Lupus","Discoid lupus erythematosus","Subacute cutaneous lupus erythematosus","M5049","Enpatoran","Cutaneous manifestations","Lupus erythematosus","Acute cutaneous lupus erythematosus","Systemic lupus erythematosus","Interferon gene signature"],"interventions":[{"type":"DRUG","name":"Enpatoran"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care (SoC)"}],"enrollment":202,"startDate":"2026-04-01","completionDate":"2029-05-25","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n* Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE).\n* Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit.\n* Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE.\n\nFor participants with SLE:\n\n* Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria.\n* Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening.\n* Participants with CLASI-A score \\>= 8 at Screening and Day 1 visits.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria\n\n* Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE.\n* Participants with any condition including dermatological diseases other than cutaneous manifestations of lupus (e.g. psoriasis), any uncontrolled disease (e.g. asthma, chronic obstructive pulmonary disease, interstitial lung disease, bronchiectasis, pulmonary arterial hypertension), or life-threatening manifestations of lupus (e.g. active systemic vasculitis) that in Investigator's or Sponsor/designee's opinion constitutes inappropriate risk or contraindication for participation.\n* Participants with drug-induced lupus (SLE or CLE).\n* Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed).\n* Participants with Urine Protein-to-Creatinine Ratio (UPCR) greater than (\\>) 339 milligrams per millimole (mg/mmol), and/or estimated Glomerular Filtration Rate (eGFR) less than 40 milliliters per minute per 1.73 square meters of body surface area (mL/min/1.73 m\\^2), as calculated by the Modification of Diet in Renal Disease (MDRD) equation.\n* Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures.\n* Other protocol-defined exclusion criteria may apply.","locations":[{"facility":"Inland Rheumatology Clinical Trials, Inc.","city":"Upland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omega Research Debary, LLC","city":"DeBary","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre for Rheumatology, Immunology and Arthritis","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Florida Rheumatology","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GTL Medical And Research Group","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bolanos Clinical Research","city":"Pembroke Pines","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vantage Clinical Trials","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Research Group, LLC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research Inc. - Lake Charles","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oakland Hills Dermatology","city":"Auburn Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis and Osteoporosis Consultants of the Carolinas II, LLC","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Superior Clinical Research, LLC","city":"Smithfield","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Texas Center for Clinical Research","city":"Frisco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prolato Clinical Research Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research","city":"Humble","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Medical Centre Clayton","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Gent - UZG","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"L2IP - Instituto de Pesquisas Clínicas Ltda.","city":"Brasília","state":"Federal District","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"A2Z Clinical Centro Avancado de Pesquisa Clinica","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Alemão Oswaldo Cruz","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"RDSS Ricardo Diaz Scientific Solution","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCC 1 Sevlievo EOOD","city":"Sevlievo","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCC \"Alexandrovska\", EOOD","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Medical Arts Health Research Group - 300128547","city":"Kelowna","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Provincial Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanfang Hospital of Southern Medical University - 300165627","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Hebei Medical University - 300184836","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science and Technology","city":"Luoyang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Baotou Medical College","city":"Baotou","state":"Inner Mongolia","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University - 300163463","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice u sv. Anny v Brne - Dept of I. Dermatovenerologicka klinika","city":"Brno","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prof.MUDr.Petr Arenberger,DrSc.MBA","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"MEDICAL PLUS s.r.o.","city":"Uherské Hradiště","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Tuebingen - Hautklinik","city":"Tübingen","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Oldenburg AoeR - Universitatsklinik f Dermatologie u. Allergologie","city":"Oldenburg","state":"Lower Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helios Klinikum Wuppertal - Klinik fuer Dermatologie, Venerologie","city":"Wuppertal","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Leipzig AoeR - Klinik u. Polikl. f.Dermatol.,Venerol. u. Allergol","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center-Derma - 150314762","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center - Neurosurgery","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Tor Vergata - U.O.C Servizio di Reumatologia","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto San Gallicano IRCCS - Istituti Fisioterapici Ospitalieri - Parent","city":"Rome","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - Dip. Medicina - U.O.C. Reumatologia","city":"Verona","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Plejady","city":"Kraków","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medycyna Kliniczna","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia MCM Krakow","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia Poznan","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"S.C Neurocity S.R.L","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr JM Engelbrecht Trial Site - 300229887","city":"Somerset West","state":"Western Cape","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Network (CTN) Helderberg","city":"Stellenbosch","state":"Western Cape","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyung Hee University Hospital at Gangdong","city":"Seoul","state":"Gangwon-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chung-ang University Gwangmyeong Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System - Division of Infectious Diseases","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Merida - Servicio de Reumatologia","city":"Mérida","state":"Badajoz","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Rio Hortega - Servicio de Medicina Interna","city":"Valladolid","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General de Castellon - Servicio de Reumatologia","city":"Castellón","state":"Castellón","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Reina Sofia - Dermatology Dep","city":"Córdoba","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz - Internal Medicine Department","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatotomi AG","city":"Weinfelden","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"IZZ Immunologie-Zentrum Zuerich - Innere Medizin, Allergologie, Immunologie","city":"Zurich","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Veterans General Hospital - Internal Medicine","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Chang Gung Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siriraj Hospital","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's Hospital - Louise Coote Lupus Unit","city":"London","state":"Greater London","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Doncaster Royal Infirmary - Dept of Rheumatology","city":"Doncaster","state":"South Yorkshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Walsall Manor Hospital","city":"Walsall","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US Medical Information","phone":"888-275-7376","email":"eMediUSA@emdserono.com"},{"name":"Communication Center","phone":"+49 6151 72 5200","email":"service@emdgroup.com"}],"primaryOutcomes":["Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) 70 Response, Defined as >= 70 Percent (%) Decrease in CLASI-A Score From Baseline"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["upland-california","debary-florida","fort-lauderdale-florida","hollywood-florida","miami-florida","pembroke-pines-florida","tampa-florida","indianapolis-indiana","lake-charles-louisiana","auburn-hills-michigan","charlotte-north-carolina","smithfield-north-carolina","frisco-texas","houston-texas","humble-texas","clayton-australia","ghent-belgium","bras-lia-brazil","campinas-brazil","s-o-paulo-brazil","sevlievo-bulgaria","sofia-bulgaria","kelowna-canada","fuzhou-china","guangzhou-china","shijiazhuang-china","luoyang-china","baotou-china","nanjing-china","suzhou-china","changchun-china","jinan-china","chengdu-china","brno-czechia","prague-czechia","uhersk-hradi-t-czechia","t-bingen-germany","oldenburg-germany","wuppertal-germany","leipzig-germany","tel-aviv-israel","rome-italy","verona-italy","krak-w-poland","szczecin-poland","warsaw-poland","bucharest-romania","somerset-west-south-africa","stellenbosch-south-africa","seoul-south-korea","seongnam-si-south-korea","m-rida-spain","valladolid-spain","castell-n-spain","c-rdoba-spain","madrid-spain","weinfelden-switzerland","zurich-switzerland","kaohsiung-city-taiwan","bangkok-thailand","london-united-kingdom","doncaster-united-kingdom","walsall-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Enpatoran for Systematic Lupus Erythematosus","inPlainEnglish":"The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease. Study details include: Study Duration: Up to 35 weeks.","whoItsFor":["Ages 18 Years to 75 Years","Vaccinations are up to date according to local guidelines/recommendations. Recombinant zoster vaccination is encouraged but not mandatory","Participants with diagnosis of Discoid Lupus Erythematosus (DLE) and/or Subacute Cutaneous Lupus Erythematosus (SCLE) documented in medical history, with or without Systemic Lupus Erythematosus (SLE)","Participants with active Acute Cutaneous Lupus Erythematosus (ACLE) as sole cutaneous manifestations is allowed in the presence of SLE and should be present for at least 6 weeks prior to the Screening visit","Participants with diagnosis of SLE fulfilling the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria, must have active DLE and/or SCLE and/or ACLE","For participants with SLE:","Participants with diagnosis of SLE and fulfill EULAR/ACR 2019 classification criteria","Participants with disease duration (cutaneous disease and, where applicable, SLE) of \\>= 6 months from time of diagnosis to Screening"],"whoShouldSkip":["Participants with primary diagnosis of autoimmune rheumatic disease (e.g., systemic sclerosis, rheumatoid arthritis) other than Cutaneous Lupus Erythematosus (CLE) and SLE","Participants with drug-induced lupus (SLE or CLE)","Participants with active lupus nephritis on induction therapy, or induction therapy completed within 3 months of the Screening visit (stable maintenance therapy with either mycophenolate azathioprine or an oral calcineurin inhibitor is allowed)","Participants with any active signs, symptoms, or diagnoses considered related to Central Nervous System (CNS) lupus within the past 3 months, or any history of uncontrolled seizures","Other protocol-defined"],"whatHappens":"If you join, the listed intervention(s) are Enpatoran, Placebo, or Standard of care (SoC). The registry lists allocation as randomized. The purpose of this global, multicenter, Phase 3 study is to measure the how well it works and safety of enpatoran over 24 weeks in participants with active cutaneous manifestations of lupus erythematosus with or without systemic disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 202 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.272Z"},{"nctId":"NCT07356973","title":"Irinotecan-ChemoSeed in Surgically Resectable Glioblastoma","officialTitle":"Open-label Phase 2 Safety and Efficacy Trial of Irinotecan-ChemoSeed Administered Directly Into the Resection Margin in Patients With Surgically Resectable Glioblastoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"CRISM Therapeutics LTD","sponsorClass":"INDUSTRY","summary":"Part 1 (dose escalation, safety, and preliminary efficacy) Part 1 is a non-randomised, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection.\n\nPart 1 will evaluate safety, determine the MTD of irinotecan-ChemoSeed and the RP2D (corresponding to coverage of as much of the resection cavity as possible, up to the MTD) and evaluate efficacy. All Part 1 participants will be administered irinotecan- ChemoSeed concurrent to Standard of Care (SoC) treatment. Part 1 dose- escalation will start at 72 mg of IRN Part 2, in 135 participants with newly diagnosed GBM suitable for maximal safe surgical resection, will assess the efficacy of irinotecan-ChemoSeed. The actual number of irinotecan-ChemoSeeds administered into the resected tumour margin of the tumour cavity after surgical resection will be at the discretion of the neurosurgical consultant up to the MTD, to cover as much of the resection cavity as possible. Participants will be randomised in a 2:1 ratio:\n\n* Arm 1: Irinotecan-ChemoSeed +SoC: Irinotecan-Chemoseeds administered into the resection margin following maximal safe surgical resection, with fractionated RT, concomitant and maintenance TMZ (based on Stupp protocol) starting 4 to 6 weeks after surgery per institution standard practice.\n* Arm 2: SoC treatment only: maximal safe surgical resection with fractionated RT, concomitant and maintenance TMZ (based on Stupp protocol) starting 4 to 6 weeks after surgery per institution standard practice.","conditions":["Glioblastoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM"}],"enrollment":147,"startDate":"2026-08-20","completionDate":"2029-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Radiologically relapsed, neuropathologically verified GBM (by the WHO 2021 criteria) (Part 1) or newly diagnosed, radiologically suspected GBM (Part 2) amenable to surgical resection.\n\n  2\\. Male or female aged 18 years or older. 3. Ability to understand and the willingness to sign a written informed consent form (ICF).\n\n  4\\. KPS ≥ 70. 5. Life expectancy ≥ 6 months. 6. Adequate organ and marrow function as follows (all required):\n  1. Absolute neutrophil count ≥ 1.5 k/µL\n  2. Platelets ≥ 100 k/µL\n  3. Haemoglobin ≥ 9 g/dL\n  4. Serum creatinine ≤ 1.8 mg/dL or creatinine clearance \\> 50 mL/min\n  5. Bilirubin ≤ 1.5 mg/dL\n  6. Alanine aminotransferase (ALT) ≤ 3.0 × upper limit of normal (ULN)\n  7. Aspartate aminotransferase (AST) ≤ 3.0 × ULN\n  8. Prothrombin time ≤ 1.5 × ULN\n  9. International normalised ratio (INR) ≤ 1.5 × ULN\n  10. Partial thromboplastin time ≤ 1.5 × ULN 7. Women of childbearing potential must agree to use a highly effective method of contraception for the duration of the trial or for 5X the systemic half-life (i.e., 6 weeks) plus 6 months following irinotecan-ChemoSeed administration, whichever is the longest.. Female participants must refrain from egg donation during the same time period. 8. Male participants of reproductive potential, who intend to be sexually active with a female partner of childbearing potential, must commit to use barrier contraception (e.g., condom) for the duration of the trial or for 5X the systemic half-life (i.e., 6 weeks) plus 6 months following irinotecan-ChemoSeed administration, whichever is the longest. Male participants must not donate or bank sperm during the same time period.\n\n      Exclusion Criteria:\n* 1\\. Multicentric disease defined by tumours which have multiple discrete areas of contrast enhancing or non-enhancing tumour without connecting T2/ fluid-attenuated inversion recovery (FLAIR) signal abnormality. 2. Diffuse leptomeningeal disease. 3. Not eligible for surgical resection. 4. Known hypersensitivity to IRN or PLGA. 5. Prior IRN treatment (for Part 2 participants) less than 12 months from trial enrolment 6. Pregnant or lactating women or participants who intend to get pregnant during the trial.\n\n  7\\. Prior active malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 years prior to surgical resection and trial drug administration. 8. Part 1 participants with relapsed GBM: treatment with another investigational drug or other intervention within 4 weeks prior to the surgical resection or 5 times the half-life (whichever is longer) before trial drug administration. 9. Part 2 participants with newly diagnosed GBM: prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.","locations":[{"facility":"University Hospitals Birmingham NHS Foundation Trust","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chris McConville, Pr","phone":"+44 (0) 78342 67819","email":"chrismcconville@extrudedpharmaceuticals.com"}],"primaryOutcomes":["Part 1 To determine the optimal Dose of Irinotecan (RP2D) to be administered for Part 2.","Part 2. Determination Of Progression Free Survival (PFS) to demonstrate the superiority of irinotecan-ChemoSeed compared to concurrent to SoC treatment"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["birmingham-united-kingdom"],"enrichment":{"headline":"Phase 2: testing irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM for Glioblastoma","inPlainEnglish":"Part 1 (dose escalation, safety, and preliminary how well it works) Part 1 is a non-randomly assigned, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection. Part 1 will evaluate safety, determine the MTD of irinotecan-ChemoSeed and the RP2D (corresponding to coverage of as much of the resection cavity as possible, up to the MTD) and evaluate how well it works.","whoItsFor":["Ages 18 Years to any","1\\. Radiologically relapsed, neuropathologically verified GBM (by the WHO 2021 criteria) (Part 1) or newly diagnosed, radiologically suspected GBM (Part 2) amenable to surgical resection","4\\. KPS ≥ 70. 5. Life expectancy ≥ 6 months. 6. Adequate organ and marrow function as follows (all required):","Absolute neutrophil count ≥ 1.5 k/µL","Platelets ≥ 100 k/µL","Haemoglobin ≥ 9 g/dL","Serum creatinine ≤ 1.8 mg/dL or creatinine clearance \\> 50 mL/min","Bilirubin ≤ 1.5 mg/dL"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are irinotecan-ChemoSeed implementation into the resection cavity after surgical resection of GBM. The registry lists allocation as randomized. Part 1 (dose escalation, safety, and preliminary how well it works) Part 1 is a non-randomly assigned, single-arm design in 12 participants with recurrent GBM suitable for maximal safe surgical resection.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 147 people at Birmingham. 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(Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kocaeli","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Samsun","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"}],"primaryOutcomes":["Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25","Absolute change from baseline in total symptom score (TSS) at Week 24 in participants with baseline TSS ≥ 25","Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline TSS ≥ 15","Absolute change from baseline in total symptom score (TSS) at Week 24 in participants with baseline TSS ≥ 15"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["denver-colorado","new-haven-connecticut","fort-myers-florida","jupiter-florida","miami-florida","st-petersburg-florida","stuart-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","bethesda-maryland","berkeley-heights-new-jersey","albany-new-york","new-york-new-york","fargo-north-dakota","columbus-ohio","austin-texas","dallas-texas","houston-texas","tyler-texas","fairfax-virginia","seattle-washington","caba-argentina","buenos-aires-argentina","capital-federal-argentina","c-rdoba-argentina","adelaide-australia","clayton-australia","graz-austria","salzburg-austria","sankt-p-lten-austria","vienna-austria","woluwe-saint-lambert-belgium","roeselare-belgium","goi-nia-brazil","curitiba-brazil","florian-polis-brazil","barretos-brazil","montreal-canada","hefei-china","guangzhou-china","wuhan-china","nanjing-china","nantong-china","nanchang-china","changchun-china","jinan-china","yantai-china","kunming-china","hangzhou-china","wenzhou-china","beijing-china","chongqing-china","dalian-china","fuzhou-china","shanghai-china","shenyang-china","tianjin-china","ostrava-czechia","brno-czechia","hradec-kr-lov-czechia","olomouc-czechia","prague-czechia","brest-france","le-kremlin-bic-tre-france","lens-france","marseille-france","n-mes-france","paris-france","pessac-france","poitiers-france","rennes-france","strasbourg-france","toulouse-france","vand-uvre-l-s-nancy-france","mannheim-germany","jena-germany","aachen-germany","cottbus-germany","erlangen-germany","hamburg-germany","hanover-germany","minden-germany","chhatrapati-sambhajinagar-india","pune-india","rishikesh-india","kolkata-india","delhi-india","meldola-italy","florence-italy","monza-italy","palermo-italy","padova-italy","roma-italy","verona-italy","naples-italy","novara-italy","toyoake-japan","kamogawa-japan","sapporo-japan","kobe-japan","shiwa-gun-japan","tsu-japan","kurashiki-japan","bunkyo-ku-japan","ch-japan","fukuoka-japan","kumamoto-japan","miyazaki-japan","george-town-malaysia","kota-kinabalu-malaysia","kuching-malaysia","johor-bahru-malaysia","kuala-selangor-malaysia","puebla-city-mexico","amsterdam-netherlands","utrecht-netherlands","gdansk-poland","katowice-poland","lublin-poland","skorzewo-poland","torun-poland","warsaw-poland","wa-brzych-poland","suwon-south-korea","jeonju-south-korea","seoul-south-korea","busan-south-korea","donostia-san-sebastian-spain","pozuelo-de-alarc-n-spain","el-palmar-spain","pamplona-spain","alicante-spain","barcelona-spain","las-palmas-gc-spain","le-n-spain","madrid-spain","m-laga-spain","salamanca-spain","basel-switzerland","bern-switzerland","geneva-switzerland","genolier-switzerland","changhua-taiwan","kaohsiung-city-taiwan","tainan-taiwan","taipei-taiwan","sakarya-turkey-t-rkiye","istanbul-turkey-t-rkiye","ankara-turkey-t-rkiye","bursa-turkey-t-rkiye","izmir-turkey-t-rkiye","kocaeli-turkey-t-rkiye","samsun-turkey-t-rkiye"],"enrichment":{"headline":"Phase 3: testing Pelabresib for Primary Myelofibrosis (PMF)","inPlainEnglish":"The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.","whoItsFor":["Ages 18 Years to any","DIPSS risk category of intermediate-1, intermediate-2 or high-risk","Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available)","Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation)","Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2","Blasts \\<5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening","Platelet count ≥ 100 x 10\\^9/L in the absence of growth factors or transfusions for the previous 4 weeks"],"whoShouldSkip":["Prior splenectomy at any time or splenic irradiation in the previous 6 months","Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization","Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation","History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment","Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer","Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Pelabresib, Ruxolitinib, or Placebo. The registry lists allocation as randomized. The purpose of this trial is to evaluate whether treatment with pelabresib in combination with ruxolitinib leads to improved clinical outcomes compared to ruxolitinib alone in patients with primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF) who have not previously received Janus kinase (JAK) inhibitor therapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 460 people at 160 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.060Z"},{"nctId":"NCT07358546","title":"A Study of Efimosfermin Alfa in Adults With Hepatic Impairment","officialTitle":"A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.","conditions":["Non-alcoholic Fatty Liver Disease"],"keywords":["efimosfermin alfa","Alcohol","Hepatic Impairment","Steatotic liver disease","Metabolic Dysfunction-Associated Steatohepatitis","Pharmacokinetics"],"interventions":[{"type":"DRUG","name":"Efimosfermin alfa"}],"enrollment":32,"startDate":"2026-03-13","completionDate":"2027-10-13","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Between 18 years and 70 years of age inclusive\n* Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m\\^2)\n* Male or female participants\n* Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:\n\n  * Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and\n  * Be classed during Screening as one of the following Child-Pugh classes:\n\n    * Child-Pugh B: Score 7-9 or\n    * Child-Pugh C: Score 10-15\n* Chronic (greater than \\[\\>\\] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.\n\nExclusion Criteria:\n\n* History of extrahepatic disorders possibly related to etiology of cirrhosis.\n* History of cryoglobulinemia.\n* Participants with Grade 3 ascites or refractory ascites.\n* Participants with refractory encephalopathy or significant central nervous system disease\n* History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.\n* Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.\n* Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.\n* Current, or history of known hepatocellular carcinoma (HCC).\n* Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.\n* Presence of hepatopulmonary or hepatorenal syndrome.\n* Presence of primarily cholestatic liver diseases.\n* Evidence of symptomatic or complicated cholecystitis.\n* History of pancreatic injury, pancreatitis, or other pancreatic disease.\n* History of liver transplantation, or active on the liver transplant waiting list.\n* Participants with signs of active infection\n* History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.\n* History of significant bone disease such as osteoporosis\n* Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.\n* History or presence of drug abuse.\n* Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations\n* Have previously taken efimosfermin alfa\n* Participants with Alanine Aminotransferase (ALT) value \\>3 times (x) upper limit of normal (ULN)\n* Participants with Aspartate aminotransferase (AST) value \\>=300 Units/Liter.\n* Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology \\[CKD-Epi\\] 2021) \\<45 milliliter/minute/1.73 square meter (mL/min/1.73m\\^2).\n* Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) \\>480 milliseconds (msec) (for male and female participants) at Screening\n* For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.","locations":[{"facility":"GSK Investigational Site","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa","Maximum observed serum drug concentration (Cmax) of efimosfermin alfa"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["rialto-california","miami-lakes-florida","tampa-florida","houston-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 1: testing Efimosfermin alfa for Non-alcoholic Fatty Liver Disease","inPlainEnglish":"This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.","whoItsFor":["Ages 18 Years to 70 Years","Between 18 years and 70 years of age inclusive","Body Mass Index (body-mass index (BMI)) within the range 23-40 kilogram per square meter (kg/m\\^2)","Male or female participants","Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:","Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and","Be classed during Screening as one of the following Child-Pugh classes:","Child-Pugh B: Score 7-9 or"],"whoShouldSkip":["History of extrahepatic disorders possibly related to etiology of cirrhosis","History of cryoglobulinemia","Participants with Grade 3 ascites or refractory ascites","Participants with refractory encephalopathy or significant central nervous system disease","History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures","Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease","Current, or history of known hepatocellular carcinoma (HCC)"],"whatHappens":"If you join, the listed intervention(s) are Efimosfermin alfa. The registry lists allocation as randomized. This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 32 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.147Z"},{"nctId":"NCT07359820","title":"A Study of Lirafugratinib in Non-CCA Solid Tumors With FGFR2 Fusion or Rearrangement","officialTitle":"A Phase 2, Open-Label, Single-Arm Study of Lirafugratinib in Patients With Previously Treated, Unresectable, Locally Advanced or Metastatic Solid Tumors (Excluding Cholangiocarcinoma) With FGFR2 Fusion or Rearrangement","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Elevar Therapeutics","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.\n\nParticipants will:\n\n* Take lirafugratinib regularly as instructed by their study doctor.\n* Visit the clinic as instructed for checkups and tests.\n* Keep a diary recording each time a dose of lirafugratinib is taken.","conditions":["FGFR2 Gene Fusion/Rearrangement","Other Solid Tumors, Adult"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lirafugratinib"}],"enrollment":30,"startDate":"2026-06-04","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Unresectable, locally advanced, or metastatic solid tumor (other than CCA).\n* Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor.\n* Patient must have measurable disease per RECIST v1.1• Patient has ECOG performance status of 0-1.\n* Previously (\\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies.\n* Subject has not received prior treatment with an FGFRi.\n\nExclusion Criteria:\n\n* An uncontrolled comorbidity.\n* Patient does not have adequate organ function (defined in protocol).\n* Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol).\n* QT interval corrected using Fridericia's formula (QTcF) \\> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome.\n* Clinically significant, uncontrolled cardiovascular disease.\n* CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms.","locations":[{"facility":"Mayo Clinic","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas M.D. Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Bergonie","city":"Bordeaux","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Georges François Leclerc","city":"Dijon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Leon Berard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy Cancer Campus","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Barcelona-Hospital HM Nou Delfos","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz- START MADRID","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario HM Sanchinarro-START MADRID-CIOCC","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute UK","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elevar Therapeutics","phone":"+1 (385) 276-3800","email":"info-clinicalstudy@elevartx.com"}],"primaryOutcomes":["Objective Response Rate (ORR) assessed by Independent Review Committee per RECIST v1.1."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","jacksonville-florida","tampa-florida","chicago-illinois","boston-massachusetts","rochester-minnesota","new-york-new-york","houston-texas","bordeaux-france","dijon-france","lyon-france","paris-france","seoul-south-korea","barcelona-spain","madrid-spain","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Lirafugratinib for FGFR2 Gene Fusion/Rearrangement","inPlainEnglish":"The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement. Participants will: * Take lirafugratinib regularly as instructed by their study doctor.","whoItsFor":["Ages 18 Years to any","Unresectable, locally advanced, or metastatic solid tumor (other than CCA)","Documented FGFR2 gene fusion or rearrangement per local testing of blood and/or tumor","Patient must have measurable disease per RECIST v1.1• Patient has how well you can do daily activities (ECOG score) of 0-1","Previously (\\>30 days) treated with ≥1 line of systemic therapy including chemotherapy (e.g., gemcitabine/cisplatin), immunotherapy, radiation therapy, or other approved therapies","Subject has not received prior treatment with an FGFRi"],"whoShouldSkip":["An uncontrolled comorbidity","Patient does not have adequate organ function (defined in protocol)","Patient has active infection, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV) (defined in protocol). Patients with well-controlled HBV are eligible (defined in protocol)","QT interval corrected using Fridericia's formula (QTcF) \\> 480 msec or history of prolonged QT syndrome, Torsades de pointes or familial history of prolonged QT syndrome","Clinically significant, uncontrolled cardiovascular disease","CNS metastases or primary CNS tumor that is associated with progressive neurologic symptoms"],"whatHappens":"If you join, the listed intervention(s) are Lirafugratinib. The registry lists allocation as na. The goal of this clinical trial is to evaluate if lirafugratinib is efficacious and safe to treat adult patients with previously treated, unresectable, locally advanced or metastatic solid tumors (excluding cholangiocarcinoma) harboring FGFR2 fusion or rearrangement.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.017Z"},{"nctId":"NCT07359846","title":"A Study to Investigate GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma (SOLAIRIA-2)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents With Severe Uncontrolled Asthma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Generate Biomedicines","sponsorClass":"INDUSTRY","summary":"The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.\n\nAdditional information is available at www.SOLAIRIA.com.","conditions":["Severe Asthma"],"keywords":["Asthma","Severe Asthma","Uncontrolled Asthma","Adolescent Asthma"],"interventions":[{"type":"DRUG","name":"GB-0895"},{"type":"DRUG","name":"Placebo"}],"enrollment":786,"startDate":"2026-01-20","completionDate":"2029-01","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"1. Adults and adolescents ≥ 12 and ≤ 80 years of age.\n2. Documented diagnosis of asthma for \\> 12 months.\n3. Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months.\n4. Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1.\n5. Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\<80% predicted at Screening Visit 1.\n6. Adolescents 12 to \\< 18 years of age at Screening Visit 1: A pre-BD FEV1 \\< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\< 0.80.\n7. Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period.\n8. ACQ-6 score ≥ 1.5 at the Screening Visit.\n9. Weight ≥40 kg at the Screening Visit 1\n\nExclusion Criteria:\n\n1. Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy.\n2. Other concurrent respiratory disease other than asthma, including (but not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, tuberculosis, diagnosis of chronic pulmonary disease (including but not limited to emphysema and/or chronic bronchitis), or a history of lung cancer.\n3. Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis).\n4. Any cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect subject safety, influence study findings or interpretation, or impede completion of the study.\n5. Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment.\n6. A current malignancy or previous history of cancer within 5 years before screening.\n7. Clinically significant infection that is not resolved before study enrollment.\n8. Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy.\n9. Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes.\n10. Former smokers with a smoking history of \\<10 pack-years and users of vaping/e-cigarette products must have stopped for at least 6 months before Screening Visit 1 to be eligible.\n11. Hepatitis B, C, or HIV.\n12. Major surgery within 8 weeks before Screening Visit 1 or planned surgical procedures requiring general anesthesia or inpatient status for \\>1 day during the study.\n13. Use of any anti-IL-5 therapy (e.g., mepolizumab, reslizumab, benralizumab, depemokimab) or other monoclonal antibodies used for asthma within 4 months or 5 half-lives.\n14. Previous use of tezepelumab within 12 months before Screening Visit 1 is excluded. Previous tezepelumab use is exclusionary regardless of 12-month washout if discontinuation was due to safety (intolerance) or treatment failure (lack of benefit). Prior use (at any time) of any other anti-TSLP or anti-TSLP receptor biologics is excluded.\n15. Treatment with systemic immunosuppressive/immunomodulating drugs (e.g., methotrexate, cyclosporine) within 12 weeks prior to randomization.\n16. Receipt of an investigational biologic within 4 months or 5 half-lives (whichever is longer), OR receipt of an investigational non-biologic within 30 days or 5 half-lives (whichever is longer) before Screening Visit 1.\n17. Known history of sensitivity to any component of the study treatment formulation.\n18. History of life-threatening anaphylaxis following any biologic therapy.\n19. Concurrent enrollment in another clinical study involving investigational product (IP).\n20. Subject has been randomized in the current study or previous GB-0895 studies.\n21. Any clinically meaningful abnormal finding in physical examination, vital signs, ECG, hematology, serum chemistry, or urinalysis that, in the opinion of the Investigator, may put the subject at risk, influence study results, or impede study completion.\n22. Cirrhosis (with or without hepatic dysfunction) or other active or clinically significant liver disease.\n23. Receipt of immunoglobulin or blood products within 30 days before Screening Visit 1.\n24. Receipt of live attenuated vaccines within 30 days before randomization and during the study, including the follow-up period.\n25. Receipt of the T2 cytokine inhibitor suplatast tosilate within 15 days before Screening Visit 1.\n26. Subjects treated with bronchial thermoplasty in the last 12 months before Screening Visit 1.\n27. Unwillingness or inability to follow study procedures, including poor adherence to asthma controller medications, in the opinion of the Investigator.\n28. Women who are pregnant, lactating, or planning to become pregnant during the study.\n29. History (or suspected history) of alcohol misuse or substance abuse within 2 years before Screening Visit 1.","locations":[{"facility":"Research Site 13","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 12","city":"Inglewood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 65","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 10","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 06","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 03","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research 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62","city":"London","state":"Westminster","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 70","city":"Metropolitan Borough of Wirral","state":"Wirral","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 85","city":"Honiton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site 48","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Generate Recruitment","phone":"888-469-0033","email":"solairiastudy@generatebiomedicines.com"}],"primaryOutcomes":["To evaluate the annualized asthma exacerbation rate (AAER) in adult and adolescent subjects with severe uncontrolled asthma."],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["bakersfield-california","inglewood-california","lancaster-california","west-covina-california","miami-florida","orlando-florida","tamarac-florida","tampa-florida","kansas-city-kansas","fall-river-massachusetts","southfield-michigan","ypsilanti-michigan","st-louis-missouri","new-york-new-york","dayton-ohio","oklahoma-city-oklahoma","rock-hill-south-carolina","houston-texas","san-antonio-texas","sugar-land-texas","colchester-vermont","williamsburg-virginia","mar-del-plata-argentina","buenos-aires-argentina","ciudad-aut-noma-de-buenos-aires-argentina","concepci-n-del-uruguay-argentina","san-salvador-argentina","mendoza-argentina","rosario-argentina","santa-fe-argentina","san-miguel-de-tucum-n-argentina","coffs-harbour-australia","southport-australia","mechelen-belgium","erpent-belgium","tartu-estonia","strasbourg-france","brest-france","le-kremlin-bic-tre-france","paris-france","batumi-georgia","tbilisi-georgia","vadodara-india","nagpur-india","dublin-ireland","ballinasloe-ireland","drogheda-ireland","reggio-emilia-italy","trieste-italy","brescia-italy","pavia-italy","sassari-italy","seto-shi-japan","matsuyama-japan","fukui-shi-japan","iizuka-shi-japan","isesaki-shi-japan","hiroshima-japan","asahikawa-shi-japan","himeji-japan","naka-gun-japan","yokohama-japan","ebino-japan","niigata-japan","uruma-japan","sakai-japan","toyonaka-japan","iruma-japan","chuo-ku-japan","hachioji-shi-japan","kiyose-shi-japan","shinagawa-ku-japan","tabashi-city-japan","tokyo-japan","toshima-ku-japan","fukuoka-japan","ube-japan","nakano-japan","malacca-malaysia","kuantan-malaysia","kota-kinabalu-malaysia","miri-malaysia","sungai-buloh-malaysia","auckland-new-zealand","christchurch-new-zealand","belgrade-serbia","zaje-ar-serbia","kamenitz-serbia","kragujevac-serbia","novi-sad-serbia","ko-ice-slovakia","spi-sk-nov-ves-slovakia","barcelona-spain","matar-spain","huelva-spain","m-laga-spain","seville-spain","zaragoza-spain","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","denizli-turkey-t-rkiye","samsun-turkey-t-rkiye","trabzon-turkey-t-rkiye","bursa-turkey-t-rkiye","chernivtsi-ukraine","ivano-frankivsk-ukraine","kyiv-ukraine","vinnytsia-ukraine","lutsk-ukraine","high-wycombe-united-kingdom","ashburton-united-kingdom","bristol-united-kingdom","london-united-kingdom","romford-united-kingdom","rotherham-united-kingdom","thetford-united-kingdom","nottingham-united-kingdom","sheffield-united-kingdom","somerton-united-kingdom","metropolitan-borough-of-wirral-united-kingdom","honiton-united-kingdom","plymouth-united-kingdom"],"enrichment":{"headline":"Phase 3: testing GB-0895 for Severe Asthma","inPlainEnglish":"The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers. Additional information is available at www.SOLAIRIA.com.","whoItsFor":["Ages 12 Years to 80 Years","Adults and adolescents ≥ 12 and ≤ 80 years of age","Documented diagnosis of asthma for \\> 12 months","Subjects must be on medium to high dose ICS for ≥ 12 months before Screening Visit 1 plus at least 1 additional asthma controller (e.g., LABA, LAMA) ≥ 3 months before Screening Visit 1 with no change in ICS or controller(s) for at least three months","Subjects must have a well-documented history of at least two asthma exacerbations requiring systemic corticosteroid treatment despite the use of medium-to-high dose ICS in the past 12 months before Screening Visit 1","Adults ≥ 18 years of age at Screening Visit 1, a pre-BD FEV1 \\<80% predicted at Screening Visit 1","Adolescents 12 to \\< 18 years of age at Screening Visit 1: A pre-BD FEV1 \\< 90% predicted OR, FEV1:Forced Vital Capacity (FVC) ratio \\< 0.80","Positive BD responsiveness test: Increase of at least 12% and 200 mL in FEV1 between 15 and 60 minutes after the administration of a short-acting β2-agonist (SABA) at least once during the screening period"],"whoShouldSkip":["Subjects who experience a clinically significant asthma exacerbation within 12 weeks before the Screening Visit or during the run-in period and require a change in asthma maintenance therapy","Eosinophilic disease (e.g., eosinophilic granulomatosis with polyangiitis)","Clinically significant infection that is unresolved and requires systemic antibiotic, antifungal, antiparasitic, or antiviral medications preceding enrollment","A current malignancy or previous history of cancer within 5 years before screening","Clinically significant infection that is not resolved before study enrollment","Subjects with a known, pre-existing helminth parasitic infestation within 6 months before Screening Visit 1 that has not been successfully treated with, or has failed to respond to, standard of care therapy","Current smokers or subjects with a smoking history ≥10 pack-years, and subjects using vaping products, including electronic cigarettes"],"whatHappens":"If you join, the listed intervention(s) are GB-0895, or Placebo. The registry lists allocation as randomized. The objective of this study is to assess the potential for GB-0895 to improve the health of adolescents and adults with severe asthma that is uncontrolled by inhaled corticosteroids (ICS) and conventional asthma controllers.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 786 people at 157 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.348Z"},{"nctId":"NCT07360080","title":"Long-Term Outcomes of Teplizumab in Routine Clinical Care","officialTitle":"Long-Term Outcomes of Participants Treated With Teplizumab in Routine Clinical Care","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.","conditions":["Type 1 Diabetes"],"keywords":[],"interventions":[{"type":"DRUG","name":"Teplizumab"}],"enrollment":1000,"startDate":"2026-03-19","completionDate":"2035-10-29","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria -\n\n* Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment.\n* Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab.\n\n(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)\n\n• Participants (or their legal guardians, as applicable) who provide appropriate written or electronic informed consent/assent as applicable for the age of the participant and as per local regulations.\n\nExclusion Criteria -\n\n* Participants who had participated in a previous clinical trial for teplizumab.\n* Participants enrolled in a clinical trial within 6 months prior to study enrollment.\n\n(Note: Participants enrolled in other observational studies may be included.)\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number: 8400006","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400003","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400004","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400001","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400002","city":"Syosset","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 8400005","city":"Sandy City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760004","city":"Hanover","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3760003","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3760002","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3760001","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 7840001","city":"Abu Dhabi","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 7840002","city":"Abu Dhabi","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Time from teplizumab infusion start to the onset of Stage 3 T1D"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","atlanta-georgia","new-york-new-york","syosset-new-york","sandy-city-utah","hanover-germany","petah-tikva-israel","ramat-gan-israel","abu-dhabi-united-arab-emirates"],"enrichment":{"headline":"Not a traditional drug phase: testing Teplizumab for Type 1 Diabetes","inPlainEnglish":"This is an watch-and-measure (no experimental treatment required), prospective cohort study designed to measure the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites.","whoItsFor":["Participants who have received at least 1 teplizumab infusion within 6 weeks prior to enrollment","Participants must have a confirmed diagnosis of Stage 2 T1D according to the treating physician at the time of the first infusion of teplizumab","(Note: Participants who progress to Stage 3 T1D by Week 6 will still be eligible, provided they were in Stage 2 at the time of the first teplizumab infusion.)"],"whoShouldSkip":["Participants who had participated in a previous clinical trial for teplizumab","Participants enrolled in a clinical trial within 6 months prior to study enrollment","(Note: Participants enrolled in other watch-and-measure (no experimental treatment required) studies may be included.)","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.925Z"},{"nctId":"NCT07360405","title":"Dietary Intervention for Migraine Relief","officialTitle":"Diet-Based Treatment for Migraine Relief","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"American University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate whether a low-glutamate diet can improve migraine symptoms in adults with migraine and to explore possible biological changes associated with dietary improvement. The study focuses on whether reducing dietary glutamate intake may influence processes involved in migraine, such as brain excitation, inflammation, and oxidative stress.\n\nThe main questions this study aims to answer are:\n\nDoes following a low-glutamate diet reduce the number of migraine days and the severity and duration of migraine attacks, and improve quality of life?\n\nAre improvements in migraine symptoms associated with changes in blood-based biological markers related to migraine activity?\n\nResearchers will compare participants assigned to the low-glutamate diet with participants assigned to a wait-list control group to evaluate differences in migraine outcomes and related biological measures.\n\nParticipants will:\n\nComplete a baseline run-in period while tracking headaches using a daily migraine diary\n\nEither follow a low-glutamate dietary intervention or continue their usual diet as part of a wait-list control\n\nComplete standardized questionnaires related to migraine symptoms and quality of life\n\nProvide blood samples for laboratory analyses\n\nUndergo neuroimaging assessments (for a subset of participants)","conditions":["Migraine"],"keywords":["Migraine","Chronic pain","Diet","Glutamate"],"interventions":[{"type":"BEHAVIORAL","name":"Dietary training"}],"enrollment":40,"startDate":"2026-03-02","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Men and women of all races and ethnicities\n* Age 18-75 years\n* Documented diagnosis of chronic or episodic migraine for at least 6 months, based on International Classification of Headache Disorders, 3rd edition (ICHD-III) criteria, defined as:\n\n  * 8 headache days per month, and\n  * 4 migraine days per month\n* Migraine onset before age 50\n* On a stable medication regimen for at least 1 month prior to enrollment\n* Willing to maintain stable medications throughout the study\n* Willing to discontinue supplements during the study period\n* Women of childbearing potential must be willing to use birth control during the study timeframe\n\nExclusion Criteria:\n\n* Current pregnancy, plans to become pregnant during the study timeframe, or current breastfeeding\n* Current use of medications affecting glutamatergic or gamma-Aminobutyric Acid (GABA) neurotransmission (unless discontinued under physician guidance)\n* Current use of quarterly injectable migraine preventive medications\n* Unwillingness to modify dietary intake or to stop alcohol and marijuana use during the study\n* Substance use disorder within the past year\n* Diagnosed seizure disorder\n* Severe asthma requiring past hospitalization","locations":[{"facility":"American University","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kathleen Holton","phone":"5037571578","email":"holton@american.edu"}],"primaryOutcomes":["Migraine days","Patient Global Impression of Change"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia"],"enrichment":{"headline":"Not a traditional drug phase: Dietary training for Migraine","inPlainEnglish":"The goal of this clinical trial is to evaluate whether a low-glutamate diet can improve migraine symptoms in adults with migraine and to explore possible biological changes associated with dietary improvement. The study focuses on whether reducing dietary glutamate intake may influence processes involved in migraine, such as brain excitation, inflammation, and oxidative stress.","whoItsFor":["Ages 18 Years to 75 Years","Men and women of all races and ethnicities","Documented diagnosis of chronic or episodic migraine for at least 6 months, based on International Classification of Headache Disorders, 3rd edition (ICHD-III) criteria, defined as:","8 headache days per month, and","4 migraine days per month","Migraine onset before age 50","On a stable medication regimen for at least 1 month prior to enrollment","Willing to maintain stable medications throughout the study"],"whoShouldSkip":["Current pregnancy, plans to become pregnant during the study timeframe, or current breastfeeding","Current use of medications affecting glutamatergic or gamma-Aminobutyric Acid (GABA) neurotransmission (unless discontinued under physician guidance)","Current use of quarterly injectable migraine preventive medications","Unwillingness to modify dietary intake or to stop alcohol and marijuana use during the study","Substance use disorder within the past year","Diagnosed seizure disorder","Severe asthma requiring past hospitalization"],"whatHappens":"If you join, the listed intervention(s) are Dietary training. The registry lists allocation as randomized. The goal of this clinical trial is to evaluate whether a low-glutamate diet can improve migraine symptoms in adults with migraine and to explore possible biological changes associated with dietary improvement.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Washington D.C.. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.297Z"},{"nctId":"NCT07361302","title":"A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well","officialTitle":"TENACITY - A Phase III, Prospective, Randomized, Open-label, Blinded Endpoint Assessment (PROBE) to Assess Efficacy and Safety of i.v. Tenecteplase vs Standard of Care in Patients With Acute Ischemic Stroke (Including Wake-up Stroke), Last Known Well >4.5 h With Imaging Evidence of Salvageable Ischemic Tissue","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study. Participants need to have imaging that shows there is brain tissue that can still be saved. They also should not be planned to receive a procedure to remove the blood clot.\n\nThe purpose of this study is to find out whether a medicine called tenecteplase helps people recover from an acute stroke. Tenecteplase is already used to treat people within 4.5 hours after they had a stroke. This study tests if tenecteplase also helps if it is given more than 4.5 hours after the stroke.\n\nParticipants are put into 2 groups randomly, which means by chance. One group gets tenecteplase as a single injection into a vein. The other group receives standard medical practice. Participants have an equal chance of receiving tenecteplase or the standard treatment.\n\nParticipants are in the study for about 3 months. In the beginning, participants stay in the hospital for about 1 week. During the study, participants have 7 clinical examinations or visits. The last 2 of these visits will likely be done from home, allowing participants to complete certain assessments remotely. Doctors regularly test participants' recovery using a scale that measures the level of disability or dependence in daily activities. The results are compared between the 2 groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.","conditions":["Acute Ischemic Stroke"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tenecteplase"},{"type":"DRUG","name":"Standard of care treatment"}],"enrollment":1325,"startDate":"2026-02-17","completionDate":"2027-10-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \\>4.5 h before time of presumed randomisation\n4. Pre-stroke modified Rankin scale (mRS) ≤1\n5. Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)\n\nExclusion criteria:\n\n1. Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation\n2. Occlusion of the internal carotid artery (ICA)\n3. High-risk patients (increased risk of thrombolysis related hemorrhage)\n4. Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans\n5. Contra-indication to contrast brain imaging with CT and MRI\n6. Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \\> 25)\n7. Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator\n8. Imaging or clinical findings not indicative of acute ischemic stroke or suggesting stroke older than 72 h\n9. 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3: testing Tenecteplase for Acute Ischemic Stroke","inPlainEnglish":"This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke). This study is for people who had an acute stroke or woke up with a stroke and were last seen well more than 4.5 hours before joining the study.","whoItsFor":["Ages 18 Years to any","Male or female ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years","Acute ischaemic stroke (including wake-up stroke) affecting the supratentorial circulation (anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral arteries (PCA)) last known well \\>4.5 h before time of presumed randomisation","Pre-stroke modified Rankin scale (mRS) ≤1","Imaging eligibility by magnetic resonance imaging (MRI)computed tomography (CT)"],"whoShouldSkip":["Intention to proceed to mechanical thrombectomy (MT) at the same site (hospital) of randomisation","Occlusion of the internal carotid artery (ICA)","High-risk patients (increased risk of thrombolysis related hemorrhage)","Any intracranial hemorrhage detected on non-contrast computed tomography (NCCT) or MRI scans","Contra-indication to contrast brain imaging with CT and MRI","Severe stroke as assessed clinically (National Institute of Health Stroke Scale (NIHSS) \\> 25)","Non-disabling minor stroke symptoms (NIHSS ≤5), or rapidly improving symptoms at the discretion of the investigator"],"whatHappens":"If you join, the listed intervention(s) are Tenecteplase, or Standard of care treatment. The registry lists allocation as randomized. This study is open to adults who had an acute stroke caused by a clot blocking a blood vessel in the brain (acute ischemic stroke).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,325 people at 258 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.215Z"},{"nctId":"NCT07363044","title":"A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease","officialTitle":"A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alimentiv Inc.","sponsorClass":"OTHER","summary":"This is a multicentre, prospective, randomised, controlled, open-label study to assess the efficacy, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).","conditions":["Crohn Disease (CD)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Epigenome-Guided Treatment Arm"},{"type":"OTHER","name":"Investigator-Guided Treatment Arm"}],"enrollment":378,"startDate":"2025-02-01","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all of the following criteria for enrolment into the study:\n\n1. Aged 18 years or older at the time of informed consent.\n2. Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy).\n3. Active CD, as defined by HBI \\> 4 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only.\n4. Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician.\n5. Must meet all eligibility criteria for biologic therapy initiation as per local SOC, including absence of chronic/opportunistic infections as demonstrated by local protocols for human immunodeficiency virus, tuberculosis, active cytomegalovirus, hepatitis B and C, and Clostridioides difficile infection. Local vaccination protocols apply as per SOC.\n6. Nonpregnant and nonlactating. Participants of childbearing potential must agree to follow local SOC guidelines for use of biologics in pregnancy/lactation, including appropriate contraception, during the study; must agree to avoid becoming pregnant from the time of informed consent up until Week 26.\n7. If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening.\n8. If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:\n\n   * The dose is up to a maximum of prednisone ≤ 40 mg/day or budesonide ≤ 9 mg/day or equivalent.\n   * The dose has been stable for ≥ 2 weeks prior to screening.\n   * The participant is willing to initiate a corticosteroid taper within 2 weeks after initiating biologic treatment.\n9. In the opinion of the investigator, the participant is able to understand and comply with protocol requirements including treatment as assigned per the protocol.\n10. Able to participate fully in all aspects of this clinical study. Full comprehension of consent language and informed consent must be obtained from the participant, or the participant's legally acceptable representative, and documented\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria are to be excluded from the study:\n\n1. Prior treatment with VDZ or UST.\n2. Prior treatment with more than 1 advanced therapy (eg, any biologic \\[ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin\\]) or advanced oral small molecule \\[ie, Janus kinase inhibitor\\]) for CD.\n3. CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:\n\n   * Ileorectal anastomosis (rectum \\< 15 cm), or a proctocolectomy.\n   * Short bowel syndrome.\n   * All ostomies.\n   * Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis.\n   * Suspected or diagnosed active intra-abdominal or perianal abscess that have not been appropriately treated.\n4. History or current diagnosis of ulcerative colitis (unless this diagnosis was made erroneously), indeterminate colitis, idiopathic colitis (ie, colitis not consistent with CD), microscopic colitis, or colonic mucosal dysplasia (excluding dysplasia in resected adenomas).\n5. Increased risk of infectious complications (eg, recent pyogenic infection, any congenital or acquired immunodeficiency, or past organ, bone marrow, or stem cell transplantation).\n6. Any topical rectal therapy for treatment of CD within 2 weeks prior to the screening endoscopy.\n7. Nonsteroidal anti-inflammatory drugs (NSAIDs) as chronic treatment, except for cyclooxygenase-2logic selective NSAIDS (celecoxib).\n8. Faecal microbiota transplant (includes human microbiota-based therapeutics) within 4 weeks prior to randomisation.\n9. Any major surgery (in the investigator's opinion) performed within 8 weeks prior to randomisation or planned during the study.\n10. History of excessive alcohol or drug abuse that, in the opinion of the investigator, may interfere with the participant's ability to comply with the study procedures.\n11. Serious underlying disease other than CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study or would compromise participant safety (such as history of malignancies, major neurological disorders, any unstable or uncontrolled medical disorder, or any known or suspected contraindication to any of the study biologics according to local prescribing information).","locations":[{"facility":"ZAS Middelheim","city":"Antwerp","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"ZAS Vincentius","city":"Antwerp","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imeldahospital","city":"Bonheiden","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Klina","city":"Brasschaat","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Sint Jan","city":"Bruges","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"H.U.B. - Hôpital Erasme","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Antwerpen (UZA)","city":"Edegem","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Maria Middelares","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Sint Lucas","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Ghent","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Liege","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Groupe sante CHC/Clique du MontLegia","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Oostende","city":"Ostend","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Delta VZW","city":"Roeselare","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU UCL Namur asbl Site Godinne","city":"Yvoir","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eszak-Pesti Centrumkorhaz-Honvedkorhaz","city":"Budapest","state":"","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem Sebészeti","city":"Budapest","state":"","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Debreceni Egyetem Klinikai Kozpont","city":"Debrecen","state":"","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pecsi Tudomanyegyetem Klinikai Kozpont","city":"Pécs","state":"","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Szegedi Tudományegyetem, Szent-Györgyi Albert Klinikai Központ","city":"Szeged","state":"","country":"Hungary","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS \"Saverio de Bellis\", National Institute of Gastroenterology","city":"Castellana Grotte","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"S. Maria del Prato Hospital","city":"Feltre","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Careggi Padiglione San Luca Nuovo","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Sacro Cuore Don Calabria","city":"Negrar","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedale Università Padova","city":"Padova","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Agostino Gemelli University Policlinic","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Camillo-Forlanini Hospital","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UOC di Gastroenterologia ed Endoscopia Digestiva","city":"San Giovanni Rotondo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flevoziekenhuis Hospitaalweg 1","city":"Almere Stad","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"OLVG Oost","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catharina Ziekenhuis","city":"Eindhoven","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maastricht UMC","city":"Maastricht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Antonius Ziekenhuis","city":"Nieuwegein","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Radboudumc","city":"Nijmegen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elisabeth-TweeSteden Ziekenhuis (ETZ)","city":"Tilburg","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"UKC Ljubljana","city":"Ljubljana","state":"","country":"Slovenia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern Care Alliance - Fairfield General Hospital","city":"Bury","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cambridge University Hospitals NHS Trust","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hull University Teaching Hospital NHS Trust","city":"Cottingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Dudley Group NHS Foundation Trust","city":"Dudley","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiff & Vale UHB","city":"Llandough","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barts Health NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's and St. Thomas' NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oxford University Hospitals NHS Foundation Trust","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Southampton NHS Foundation Trust","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hampshire Hospital NHS Foundation Trust","city":"Winchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Earle","phone":"","email":"jennifer.earle@alimentiv.com"},{"name":"Lauren Schleicher","phone":"","email":"lauren.schleicher@alimentiv.com"}],"primaryOutcomes":["To compare the efficacy of epigenome-guided treatment selection to usual SOC treatment selection for inducing clinical remission and endoscopic response at Week 26 in participants with active CD."],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["antwerp-belgium","bonheiden-belgium","brasschaat-belgium","bruges-belgium","brussels-belgium","edegem-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","ostend-belgium","roeselare-belgium","yvoir-belgium","budapest-hungary","debrecen-hungary","p-cs-hungary","szeged-hungary","castellana-grotte-italy","feltre-italy","florence-italy","milan-italy","negrar-italy","padova-italy","roma-italy","rome-italy","san-giovanni-rotondo-italy","almere-stad-netherlands","amsterdam-netherlands","eindhoven-netherlands","maastricht-netherlands","nieuwegein-netherlands","nijmegen-netherlands","tilburg-netherlands","utrecht-netherlands","ljubljana-slovenia","bury-united-kingdom","cambridge-united-kingdom","cottingham-united-kingdom","dudley-united-kingdom","llandough-united-kingdom","london-united-kingdom","oxford-united-kingdom","southampton-united-kingdom","winchester-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Epigenome-Guided Treatment Arm for Crohn Disease (CD)","inPlainEnglish":"This is a multicentre, prospective, randomly assigned, controlled, open-label study to assess the how well it works, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).","whoItsFor":["Ages 18 Years to any","Participants must meet all of the following criteria for enrolment into the study:","Documented diagnosis of ileal, ileocolonic, or colonic CD (may be confirmed at baseline study endoscopy)","Active CD, as defined by HBI \\> 4 and SES-CD ≥ 6 for colitis/ileocolitis and ≥ 4 for ileitis only","Eligible to receive either VDZ and/or UST therapy for the treatment of CD per the approved drug label requirements and in the opinion of the treating physician","If receiving nonbiologic therapies for inflammatory bowel disease, including thiopurines and methotrexate, must have initiated at least 3 months prior to screening and must be on a stable dose for at least 2 weeks prior to screening","If receiving oral corticosteroids, the participant is eligible if they meet all the following criteria:","The dose is up to a maximum of prednisone ≤ 40 mg/day or budesonide ≤ 9 mg/day or equivalent"],"whoShouldSkip":["Participants who meet any of the following criteria are to be excluded from the study:","Prior treatment with VDZ or UST","Prior treatment with more than 1 advanced therapy (eg, any biologic \\[ie, anti- tumour necrosis factor (TNF), anti-interleukin, anti-integrin\\]) or advanced oral small molecule \\[ie, Janus kinase inhibitor\\]) for CD","CD-related complications that in the opinion of the investigator would interfere with participation in the study, including but not limited to:","Ileorectal anastomosis (rectum \\< 15 cm), or a proctocolectomy","Short bowel syndrome","Symptomatic strictures in the bowel or symptomatic strictures in the ileum or ileocecal valve that have a stenosis"],"whatHappens":"If you join, the listed intervention(s) are Epigenome-Guided Treatment Arm, or Investigator-Guided Treatment Arm. The registry lists allocation as randomized. This is a multicentre, prospective, randomly assigned, controlled, open-label study to assess the how well it works, safety, and cost-effectiveness of epigenome-guided treatment selection compared to usual standard-of-care (SOC) treatment selection in patients initiating biologic therapy for the treatment of their active Crohn's Disease (CD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 378 people at 51 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.896Z"},{"nctId":"NCT07363590","title":"A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)","officialTitle":"A Dose Escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-1045 in Participants With Systemic Lupus Erythematosus and Rheumatoid Arthritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).","conditions":["Systemic Lupus Erythematosus","Rheumatoid Arthritis"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-1045"}],"enrollment":21,"startDate":"2026-02-19","completionDate":"2029-07-16","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a body mass index between 18 and 32 kg/m\\^2, inclusive\n* Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria\n* SLE: Is taking at least one background therapy for SLE\n* RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA\n\nExclusion Criteria:\n\n* Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing\n* History of serious recurrent or chronic infection\n* Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus\n* Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB\n* Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE\n* For RA participants, has a history of any arthritis with onset before age 17 years\n* Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments\n* History of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\<5 years before Day 1 dosing\n* Has had a major surgery within 3 months prior to Screening or has a major surgery planned during the study.\n* Has symptomatic heart failure (New York Heart Association class III or IV) or myocardial infarction or unstable angina pectoris within 6 months prior to Screening\n* Has a severe chronic pulmonary disease requiring oxygen therapy\n* Has current active lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease","locations":[{"facility":"Gold Coast University Hospital ( Site 1601)","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anima Diepenbeek ( Site 0601)","city":"Diepenbeek","state":"Limburg","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent ( Site 0602)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chinese Academy of Medical Science Peking Union Medical College Hospital ( Site 1501)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science &Technology ( Site 1502)","city":"Luoyang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 1504)","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 1505)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica de la Costa S.A.S. ( Site 0101)","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncomédica S.A.S ( Site 0103)","city":"Montería","state":"Departamento de Córdoba","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Valle del Lili ( Site 0102)","city":"Cali","state":"Valle del Cauca Department","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arensia Exploartory Medicine ( Site 1301)","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas- IRCCS ( Site 1902)","city":"Rozzano","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1901)","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Tokyo Hospital ( Site 0301)","city":"Bunkyo","state":"Tokyo","country":"Japan","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Keio University Hospital ( Site 0302)","city":"Shinjyuku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"PMSI Republican Clinical Hospital \"T.Mosneaga\" ( Site 1001)","city":"Chisinau","state":"","country":"Moldova","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica San Juan Bautista ( Site 0203)","city":"Lima","state":"","country":"Peru","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARENSIA Clinics ( Site 0902)","city":"Bucharest","state":"Bucharest","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARENSIA Exploratory Medicine-Country Emergency Hospital- Arensia,Cluj-Napoca ( Site 0901)","city":"Cluj-Napoca","state":"Cluj","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chulalongkorn University ( Site 0501)","city":"Pathumwan","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ramathibodi Hospital ( Site 0503)","city":"Ratchathewi","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part 1: Number of Participants with One or More Adverse Events (AEs)","Part 1: Number of Participants who Discontinue Study Drug Due to an AE","Part 2 and Part 3: Number of Participants with One or More AEs","Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["southport-australia","diepenbeek-belgium","ghent-belgium","beijing-china","luoyang-china","wuhan-china","shanghai-china","barranquilla-colombia","monter-a-colombia","cali-colombia","tbilisi-georgia","rozzano-italy","roma-italy","bunkyo-japan","shinjyuku-japan","chisinau-moldova","lima-peru","bucharest-romania","cluj-napoca-romania","pathumwan-thailand","ratchathewi-thailand"],"enrichment":{"headline":"Phase 1: testing MK-1045 for Systemic Lupus Erythematosus","inPlainEnglish":"This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA). The main goal of the study is to learn about the safety of MK-1045 and if people tolerate it when they receive it at different dose levels (amounts).","whoItsFor":["Ages 18 Years to 75 Years","Has a body mass index between 18 and 32 kg/m\\^2, inclusive","Systemic lupus erythematosus (SLE): Has a diagnosis of SLE for at least 6 months and met the European Alliance of Associations for Rheumatology (EULAR)/ American College of Rheumatology (ACR) 2019 classification criteria","SLE: Is taking at least one background therapy for SLE","RA: Has a diagnosis of RA for at least 6 months and meets the 2010 ACR-EULAR classification criteria for RA"],"whoShouldSkip":["Has a known active infection (excluding fungal infection of nail beds), or any major episode of infection requiring hospitalization or treatment with anti-infectives within 8 weeks prior to the Day 1 dosing","History of serious recurrent or chronic infection","Is known to be infected with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus","Has evidence of active tuberculosis (TB), latent TB, or inadequately treated TB","Has a significant or uncontrolled medical disease in any organ system not related to RA or SLE","For RA participants, has a history of any arthritis with onset before age 17 years","Has a current inflammatory condition other than SLE or RA that could interfere with disease activity assessments"],"whatHappens":"If you join, the listed intervention(s) are MK-1045. The registry lists allocation as randomized. This study looks at a study medicine called MK-1045 in people with lupus and rheumatoid arthritis (RA).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 21 people at 21 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.956Z"},{"nctId":"NCT07363642","title":"Phase 3b Study in Patients With Severe Asthma Treated With Tezepelumab","officialTitle":"TAPER: A Prospective, Interventional, Multicentre, Single-Arm, Phase 3b Study to Evaluate the Step-Down of Maintenance Therapy in Patients With Severe Asthma Treated With Tezepelumab","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.","conditions":["Severe Asthma"],"keywords":["Severe Asthma"],"interventions":[{"type":"DRUG","name":"Tezepelumab"}],"enrollment":400,"startDate":"2026-01-28","completionDate":"2028-02-07","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of informed consent prior to any study-specific procedures. Written informed consent, and assent when applicable for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent\\[s\\]/guardian\\[s\\]) and according to international guidelines and/or applicable local guidelines.\n\n   Age 2. Patient must be aged 12-80 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study.\n\n   Type of Patient and Disease Characteristics 3. Documented history of physician-diagnosed asthma prior to Visit 1 • Evidence of asthma as documented within 12 months prior to Visit 1 by either: (1) a positive bronchodilator (BD) responsiveness (reversibility), defined as an increase in FEV1 of ≥12% and ≥200 mL after inhalation of a bronchodilator, or an increase in FEV1 of ≥12% and ≥200 mL from baseline after 4 weeks of anti-inflammatory treatment containing ICS; or (2) a positive bronchial provocation test, defined as a decrease in FEV1 of ≥20% after inhalation of a provoking agent, commonly methacholine or histamine; or (3) average daily diurnal variability in PEF of \\>10%, calculated over at least 7 consecutive days as the sum of the daily diurnal PEF variability values divided by the number of days; or (4) a excessive variation in lung function between visits, defined as change in FEV1 of ≥12% and ≥200 mL. In the absence of any such positive record in the previous 12 months, variable expiratory airflow must be confirmed and documented at Visit 1 4. Documented current maintenance treatment with MD/HD ICS + LABA with up to one additional controller • Other acceptable asthma controller includes LTRA, LAMA or theophylline 5. On stable MD/HD ICS (\\>250μg fluticasone propionate dry powder formulation equivalents total daily dose) + LABA stable for ≥2 months prior to enrollment 6. On stable LTRA or LAMA or theophylline (≥2 weeks) is allowed 7. In asthma uncontrolled status at Visit 1, asthma uncontrolled defined as at least one of the following:\n   1. Documented ACQ-5 ≥ 1.5 at Visit 1, Or\n   2. Documented exacerbation in the year prior to Visit 1 in either situation as below:\n\n      • ≥ 2 times of symptomatic worsening requiring systemic corticosteroid (including a temporary increase in a stable oral corticosteroid background dose) for at least 3 days; a single depo-injectable dose of corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids , OR,\n\n      • At least one emergency room visit (defined as evaluation and treatment for \\<24 hours in an emergency department) due to asthma, OR, At least one inpatient hospitalization (defined as admission to an inpatient facility and/or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma Source documentation is required for physician-diagnosed asthma, ICS-LABA use and asthma exacerbations over the prior year. A patient verbal history suggestive of asthma symptoms and/or prior asthma exacerbations, but without supporting documentation, is not sufficient to satisfy these inclusion criteria.\n\n      Examples of acceptable documentation of the asthma disease state and prior asthma exacerbations include clinic visit (primary or specialist Health care provider (HCP)), emergency room/urgent care, or hospital records listing asthma as a current problem, plus documentation of at least 1 asthma exacerbations during the 12 months prior to ICF.\n   3. With persistent airflow limitation despite adequate bronchodilator therapy, defined as FEV1 \\<80% predicted, FEV1/FVC\\<70% 8. Documented at least one exacerbation in the year prior to enrolment Visit 1 \\[definition refers to section 8.2.2\\] Sex and Contraceptive/Barrier Requirements 9. Male and/or female Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\n   Female patients:\n\n   • Females not of childbearing potential are defined as females who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Females will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to Visit 1(Week -1 to Week 0) without an alternative medical cause. The following age-specific requirements apply:\n\n   • Females \\< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.\n\n   • Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.\n\n   • Female patients of childbearing potential must use one highly effective form of birth control. A highly effective method of contraception is defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly. Females of childbearing potential who are sexually active with a non-sterilised male partner must agree to use one highly effective method of birth control, as defined below, from enrolment throughout the study and until at least 8 weeks after last dose of study intervention. Cessation of contraception after this point should be discussed with a responsible physician.\n\n   • The following are not acceptable methods of contraception: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea. Female condom and male condom should not be used together.\n   * All WOCBP must have a negative serum pregnancy test result at Visit 1(Week -1 to Week 0).\n   * Highly effective birth control methods include: Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the patient (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments) \\[(periodic abstinence eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of exposure to study intervention, and withdrawal are not acceptable methods of contraception\\], a vasectomised partner, Implanon®, bilateral tubal occlusion, intrauterine device/levonorgestrel intrauterine system, Depo-Provera™ injections, oral contraceptive, and Evra Patch™, Xulane™, or NuvaRing®.\n\n   Exclusion Criteria:\n\n   Medical Conditions\n\n1．Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator.\n\n2\\. Current active clinically important pulmonary disease other than asthma (e.g., active lung infection, chronic obstructive pulmonary disease \\[COPD\\], bronchiectasis, pulmonary fibrosis, cystic fibrosis), or ever been diagnosed with pulmonary or systemic disease, other than asthma, that is associated with elevated peripheral eosinophil counts (e.g., allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome).\n\n* Within the 12 months prior to Visit 1, a CT scan is required to exclude related diseases.\n\n  3．Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of \\<10 pack years must have stopped for at least 6 months to be eligible.\n\n  4．History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0).\n\n  5．A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1(Week -1 to Week 0) that has not been treated with, or has failed to respond to, standard of care therapy.\n\n  6．History of rapid allergic reaction, anaphylaxis to any biologic therapy. 7．Known history of allergy or reaction to any component of the study treatment formulation.\n\n  8．Respiratory exacerbation requiring use of Systemic corticosteroids (SCS) or acute upper/lower respiratory infection that required antibiotics or antiviral medication within 30 days prior to Visit 1(Week -1 to Week 0). An extension of the screening period up to 3 months is allowed to ensure that a patient recovering from any respiratory exacerbation or acute upper/lower respiratory infection can be included.\n\n  9．A history of known immunodeficiency disorder, including human immunodeficiency virus.\n\n  10．Current or history of malignancy within 5 years before the screening visit with the following exceptions:\n* In-situ carcinoma of the cervix where curative therapy has been completed and patients are in remission for at least 12 months prior to screening.\n* Basal cell or superficial squamous skin cancer.\n* Patients who have had other malignancies are eligible provided that the patient is in remission and curative therapy was completed at least 5 years prior to the date informed consent was obtained.\n\n  11．Exclusion for any of the following:\n* Previous allogeneic bone marrow transplant.\n* Tuberculosis requiring treatment within the 12 months before Visit 1.\n* Non-leucocyte depleted whole blood transfusion within 120 days of genetic sample collection.\n\n  12．Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:\n\n  (a) Affect the safety of the patient throughout the study, (b) Confound the study results or impact the scientific validity of the data outcome, (c) Impede the patient's ability to complete the entire duration of study. Prior/Concomitant Therapy 13．Systemic corticosteroid used during 4 weeks prior to Tezepelumab first injection (Week 0).\n\n  14．Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroid, or any experimental anti-inflammatory therapy) within 3 months or 5 half-lives (whichever is longer) prior to the date informed consent is obtained.\n\n  15．Receipt of any marketed or investigational biologic agent within 4 months or 5 half -lives (whichever is longer) prior to Visit 1(Week -1 to Week 0) or receipt of any investigational non biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1(Week -1 to Week 0). Exception:\n  1. For marketed non-respiratory biologics, it is allowed if the patient is stable on treatment for at least 3 months prior to Visit 1(Week -1 to Week 0) and throughout the study.\n  2. Covid-related prevention and treatment 16．Receipt of live attenuated vaccines 30 days prior to the date of first dose of Tezepelumab.\n\n     17．Intention to use any concomitant medication that is not permitted or failure to complete the required washout period for a particular prohibited medication.\n\n     18．Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained.\n\n     19．Received bronchial thermoplasty (BT) as treatment of asthma within 12 months prior to Visit 1.\n\n     20．Received treatment with traditional Chinese herbs or proprietary Chinese medicines that have anti-asthmatic effects (excluding topical Chinese herbs) within 4 weeks prior to Visit 1 (Week -1 to Week 0) Prior/Concurrent Clinical Study Experience 21．Concurrent participation in another clinical study with an Investigational Product or a post-authorization safety study\n\n     Diagnostic Assessments 22．Any clinically significant abnormal findings in physical examination, medical history, vital signs, haematology, or clinical chemistry during the enrolment period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient's ability to complete the entire duration of the study, e.g. active liver disease, Receipt of live attenuated vaccines 30 days prior to the date of visit 1.\n\n     Other Exclusions 23．For females only - currently pregnant (confirmed with positive pregnancy test), breast-feeding, or lactating.\n\n     24．Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n\n     25．Judgement by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.\n\n     26．Previous enrolment in the present study.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Binzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changsha","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Deyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guiyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hohhot","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jiangmen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jining","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kunming","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leshan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Linyi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Luzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Meizhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mianyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanning","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ningbo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Quanzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shantou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenyang","state":"","country":"China","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Shenzhen","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Suining Shi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Suzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taiyuan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Weifang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wenzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuxi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xi'an","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhanjiang","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhengzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhongshan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control","To assess the potential for Tezepelumab treated patients to reduce their standard of care asthma controller regimen in the overall patient population while maintaining asthma control"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["beijing-china","binzhou-china","changsha-china","chengdu-china","chongqing-china","deyang-china","fuzhou-china","guangzhou-china","guiyang-china","hangzhou-china","hefei-china","hohhot-china","jiangmen-china","jinan-china","jining-china","kunming-china","leshan-china","linyi-china","luzhou-china","meizhou-china","mianyang-china","nanchang-china","nanjing-china","nanning-china","ningbo-china","quanzhou-china","shanghai-china","shantou-china","shenyang-china","shenzhen-china","shijiazhuang-china","suining-shi-china","suzhou-china","taiyuan-china","tianjin-china","weifang-china","wenzhou-china","wuhan-china","wuxi-china","xian-china","zhangzhou-china","zhanjiang-china","zhengzhou-china","zhongshan-china"],"enrichment":{"headline":"Phase 3: testing Tezepelumab for Severe Asthma","inPlainEnglish":"This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.","whoItsFor":["Ages 12 Years to 80 Years","Age 2. Patient must be aged 12-80 years old, inclusively, at the time of Visit 1(Week -1 to Week 0) For those patients, who are 17 on the day of Visit 1(Week -1 to Week 0) but will turn 18 after this day, will be considered an adolescent for the purposes of this study","Documented ACQ-5 ≥ 1.5 at Visit 1, Or","Documented exacerbation in the year prior to Visit 1 in either situation as below:","Females \\< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range","Females ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment","The following are not acceptable methods of contraception: periodic abstinence (calendar, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhoea. Female condom and male condom should not be used together","All WOCBP must have a negative serum pregnancy test result at Visit 1(Week -1 to Week 0)"],"whoShouldSkip":["1．Unable to commit to the scheduled visits as required by the protocol, or unable to commit to undergoing protocol guided reductions in asthma therapy, as directed by the Investigator","Within the 12 months prior to Visit 1, a CT scan is required to exclude related diseases","3．Current smokers at Visit 1 are not allowed. Former smokers with smoking history ≥ 10 pack-years at Visit 1 are not allowed; Former smokers with a smoking history of \\<10 pack years must have stopped for at least 6 months to be eligible","4．History of alcohol or drug abuse within 12 months prior to Visit 1(Week -1 to Week 0)","5．A helminth parasitic infection diagnosed within 24 weeks prior to Visit 1(Week -1 to Week 0) that has not been treated with, or has failed to respond to, standard of care therapy","6．History of rapid allergic reaction, anaphylaxis to any biologic therapy. 7．Known history of allergy or reaction to any component of the study treatment formulation","9．A history of known immunodeficiency disorder, including human immunodeficiency virus"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab. The registry lists allocation as na. This study aims to explore the potential for Tezepelumab-treated severe asthmatic patients to effectively and safely reduce their background maintenance medication while maintaining asthma symptom control.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.347Z"},{"nctId":"NCT07366034","title":"A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)","officialTitle":"A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD.\n\nFor participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine.\n\nParticipants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part.\n\nYoung participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years.\n\nDepending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.","conditions":["Fibrosing Interstitial Lung Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nerandomilast"},{"type":"DRUG","name":"Placebo"}],"enrollment":35,"startDate":"2026-07-21","completionDate":"2029-04-27","sex":"ALL","minAge":"2 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children and adolescents 2 to \\<18 years old at Visit 2.\n* Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.\n* For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2.\n* Participants with clinically significant fibrosing ILD at Visit 2, as assessed by the investigator based on any of the following:\n\n  * Fan score ≥3, or\n  * Documented evidence of clinical progression over time based on either\n\n    * a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or\n    * a ≥10% relative decline in FVC % predicted, or\n    * increased fibrosis on HRCT, or\n    * other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous treatment with nerandomilast.\n* Participants treated with other oral/systemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1.\n* Participants treated with pirfenidone in the 8 weeks prior to Visit 1.\n* Unstable pulmonary arterial hypertension (PAH).\n* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period.\n* Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) in the past (lifetime).\n* Any suicidal ideation of type 4 or 5 on the columbia suicidal severity rating scale (C-SSRS) in the past 3 months at Visit 1 or at Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent, and plan).\n* Participants with clinically significant depression symptoms defined as the short version of mood and feeling questionnaire (SMFQ) score ≥8.\n\nFurther exclusion criteria apply.","locations":[{"facility":"Children's Hospital Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M Health Fairview Masonic Children's Hospital","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Respirar","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Women's and Children's Hospital","city":"North Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brussels - UNIV HUDERF","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Serviços Medicos Respirar Sul Fluminense","city":"Barra Mansa","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles","city":"Porto Alegre","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMIP Pernambuco","city":"Recife","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alberta Children's Hospital","city":"Calgary","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Hospital for Sick Children","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Children's Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Provincial People's Hospital","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Motol","city":"Prague","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aarhus University Hospital","city":"Aarhus N","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö","city":"Helsinki","state":"","country":"Finland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tampere University Hospital","city":"Tampere","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Femme Mère Enfant","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Intercommunal","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Timone","city":"Marseille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"HOP Armand-Trousseau","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"HOP Necker - Enfants Malades","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité - Universitätsmedizin Berlin","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamburger Zentrum für Kinder- und Jugendrheumatologie","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Hochschule Hannover","city":"Hanover","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aristotle University, Thessaloniki","city":"Thessaloniki","state":"","country":"Greece","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituto G. Gaslini","city":"Genova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesù","city":"Roma","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka Children's Hospital","city":"Fukuoka, Fukuoka","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Osaka Women's and Children's Hospital","city":"Osaka, Izumi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Center for Child Health and Development","city":"Tokyo, Setagaya-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)","city":"Guadalajara","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute S.C.","city":"Tlalnepantla","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam University Medical Center","city":"Amsterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Center of the Medical University of Warsaw","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ULS de Santa Maria, E.P.E - Hospital de Santa Maria","city":"Lisbon","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Birmingham Children's Hospital","city":"Birmingham","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-0127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Area under the concentration curve (AUC) T,SS based on sampling at steady state using rich sampling in participants from 6 years to less than 18 years and sparse sampling in participants younger than 6 years","Occurrence of a treatment-emergent adverse event"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","aurora-colorado","baltimore-maryland","boston-massachusetts","minneapolis-minnesota","columbus-ohio","philadelphia-pennsylvania","caba-argentina","north-adelaide-australia","brussels-belgium","barra-mansa-brazil","porto-alegre-brazil","recife-brazil","s-o-paulo-brazil","calgary-canada","toronto-canada","beijing-china","changsha-china","shanghai-china","prague-czechia","aarhus-n-denmark","helsinki-finland","tampere-finland","bron-france","cr-teil-france","marseille-france","paris-france","berlin-germany","hamburg-germany","hanover-germany","thessaloniki-greece","genova-italy","roma-italy","fukuoka-fukuoka-japan","osaka-izumi-japan","tokyo-setagaya-ku-japan","guadalajara-mexico","tlalnepantla-mexico","amsterdam-netherlands","warsaw-poland","lisbon-portugal","seoul-south-korea","barcelona-spain","seville-spain","birmingham-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Nerandomilast for Fibrosing Interstitial Lung Disease","inPlainEnglish":"This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis.","whoItsFor":["Ages 2 Years to 17 Years","Children and adolescents 2 to \\<18 years old at Visit 2","Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review","For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2","Participants with clinically significant fibrosing ILD at Visit 2, as assessed by the investigator based on any of the following:","Documented evidence of clinical progression over time based on either","a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or","a ≥10% relative decline in FVC % predicted, or"],"whoShouldSkip":["Previous treatment with nerandomilast","Participants treated with other oral/systemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1","Participants treated with pirfenidone in the 8 weeks prior to Visit 1","Unstable pulmonary arterial hypertension (PAH)","Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period","Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) in the past (lifetime)","Any suicidal ideation of type 4 or 5 on the columbia suicidal severity rating scale (C-SSRS) in the past 3 months at Visit 1 or at Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent, and plan)"],"whatHappens":"If you join, the listed intervention(s) are Nerandomilast, or Placebo. The registry lists allocation as randomized. This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 35 people at 47 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.418Z"},{"nctId":"NCT07366892","title":"Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use","officialTitle":"Fluorescence Visualization and Image Quality Evaluation of Digital Visualization of Suspected Grade III and/or IV Gliomas During Neurosurgery (Leica GLOW400)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Leica Microsystems (Schweiz) AG","sponsorClass":"INDUSTRY","summary":"This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in neurosurgery. It is a non-interventional, observational study conducted in routine care settings across multiple European sites.","conditions":["Suspected Grade III and IV Gliomas Requiring Surgical Intervention","Neurosurgical Procedure","Glioma","Glioblastoma (GBM)"],"keywords":["GLOW400","ARveo8x","Digital surgical microscope","5-ALA fluorescence","Image quality assessment","Grade III gliomas","Grade IV gliomas","High-grade glioma","fluorescence-guided surgery"],"interventions":[{"type":"DEVICE","name":"GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery."}],"enrollment":37,"startDate":"2026-04-28","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Candidates for the for the IMED-GLOW400 Study must be appropriate patients for surgical interventions with suspected intracranial high-grade glioma evidenced by preoperative imaging modalities and have to fulfil all of the following inclusion criteria to be eligible for the recruitment of the study.\n\nInclusion Criteria\n\n1. Participants must be 18 years of age or older at the time of signing the informed consent.\n2. Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention.\n3. The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use.\n4. The participant or their legal representative must understand the study and have voluntarily signed and dated the Informed Consent Form, which has been approved by the Sponsor and the Ethics Committee for this study.\n\nNote for Switzerland only:\n\nEnrollment via legal representative is not permitted. Therefore, only patients who are capable of providing informed consent themselves will be eligible for inclusion in Switzerland.\n\nExclusion Criteria\n\n1. Known allergy to 5-ALA hydrochloride or protoporphyrin.\n2. Patients with porphyria (a condition characterized by the inability to break down protoporphyrin).\n3. Any uncontrolled systemic condition that may adversely affect the surgical outcome.\n4. Patients holding United States citizenship.","locations":[{"facility":"Unidade Local de Saúde de São João","city":"Porto","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Leica Microsystems Clinical Affairs Department","phone":"+41 796428004","email":"clinical.affairs@leica-microsystems.com"}],"primaryOutcomes":["Flourescence visibility","Image quality","Anatomy of the brain, including Vessels (GLOW400 Anatomy only)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["porto-portugal","basel-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery. for Suspected Grade III and IV Gliomas Requiring Surgical Intervention","inPlainEnglish":"This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope. The study evaluates fluorescence visualization and image quality during standard surgical procedures in neurosurgery.","whoItsFor":["Ages 18 Years to any","Participants must have suspected high-grade glioma (WHO grade III-IV) as evidenced by preoperative imaging modalities, which require surgical intervention","The active substance 5-aminolevulinic acid (5-ALA) fluorescence dye is administered according to the 5-ALA instructions for use","Note for Switzerland only:"],"whoShouldSkip":["Known allergy to 5-ALA hydrochloride or protoporphyrin","Patients with porphyria (a condition characterized by the inability to break down protoporphyrin)","Any uncontrolled systemic condition that may adversely affect the surgical outcome","Patients holding United States citizenship"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 37 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.480Z"},{"nctId":"NCT07367282","title":"Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration","officialTitle":"A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Junyeop Lee","sponsorClass":"OTHER","summary":"If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye.\n\nAfter screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes.\n\nThroughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T\\&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections.\n\nIf the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.","conditions":["Macular Degeneration"],"keywords":["Neovascular Age-related Macular Degeneration"],"interventions":[{"type":"DRUG","name":"Faricimab Injection [Vabysmo]"}],"enrollment":64,"startDate":"2026-06-29","completionDate":"2028-04-30","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Individuals who voluntarily agree to participate in this clinical study and provide written informed consent\n2. Male or female adults aged 50 years or older at the time of consent\n3. Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol\n\nOcular Conditions\n\n1. Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.\n2. Confirmed diagnosis, by the investigator, of active nAMD based on sufficiently clear ocular media and adequate pupillary dilation allowing acquisition of good quality retinal images for confirmation.\n3. Treatment naïve patients\n4. For PCV patients, presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy\n5. For PCV patients, greatest liner dimension (GLD) of the total lesion area \\<5400 μm as delineated by ICGA.\n\nExclusion Criteria:\n\n1. Any major illness or major surgical procedure within 1 month before screening.\n2. Any condition that, in the opinion of the investigator, constitutes a contraindication to the use of faricimab, may affect interpretation of study results, or places the participant at high risk for treatment-related complications, based on medical history, non-diabetic metabolic abnormalities, physical examination findings, or past/current clinical laboratory results.\n3. History of active cancer within 12 months prior to screening, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 (Grade Group 1) and stable PSA levels for \\>12 months.\n4. Uncontrolled blood pressure, defined as systolic \\>180 mmHg and/or diastolic \\>100 mmHg while at rest at baseline. A repeat reading within the screening window may be taken to confirm eligibility.\n5. Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH).\n6. History of severe allergic or anaphylactic reaction to biologic agents, or known hypersensitivity to any component of the faricimab injection, study-related procedures (including fluorescein and indocyanine green dyes), dilating drops, or any anesthetic/antimicrobial eye drops used during the study.\n7. Systemic treatment for suspected or active systemic infection at screening. Ongoing prophylactic antibiotic use may be acceptable at the investigator's discretion.\n8. Use of systemic medications known to have toxic effects on the lens, retina, or optic nerve within 6 months prior to screening or within 5 drug half-lives (whichever is longer), or expected future use of such medications.\n9. Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer).\n10. Participation in another clinical study involving an investigational drug, investigational device, or other medical research within 3 months prior to screening, or concurrent participation in such a study.\n11. Pregnant or breastfeeding women.\n12. Women of childbearing potential planning to become pregnant during the study or within 3 months after the last dose of study treatment, or unwilling to use highly effective contraception methods\\* throughout the study period and for 3 months following the last dose.\n\nOcular Conditions\n\n1. Any ocular condition in the study eye that may interfere with the assessment of visual acuity, safety evaluation, or fundus imaging (e.g., advanced cataract).\n2. Any current ocular disease in the study eye that, in the opinion of the investigator, increases the procedural risk of intravitreal injection beyond standard expectations or may interfere with injection, efficacy, or safety evaluations.\n3. Presence of fibrosis or atrophy involving ≥50% of the total lesion area and/or the fovea in the study eye, as determined by the investigator.\n4. Presence of retinal pigment epithelial (RPE) tear involving the macula in the study eye.\n5. High myopia with spherical equivalent refractive error \\>6 diopters in the study eye. For participants with a history of refractive or cataract surgery, pre-surgical refractive error must not have exceeded -6 diopters.\n6. Presence of vitreous hemorrhage in the study eye at screening or baseline visits.\n7. History of other macular diseases in the study eye that are unrelated to nAMD but may lead to visual loss or cause intraretinal fluid (IRF) or subretinal fluid (SRF).\n8. History or clinical evidence of proliferative diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye, other than AMD.\n9. Any current ocular condition in the study eye (e.g., cataract) that, in the opinion of the investigator, may require medical or surgical intervention during the study period.\n10. History of prior intraocular surgery in the study eye, including but not limited to vitrectomy, glaucoma surgery, corneal transplant, radiation therapy, retinal detachment repair (e.g., scleral buckle or pneumatic retinopexy), trabeculectomy, or other filtration surgeries.\n11. History of prior or ongoing treatment for macular neovascularization (MNV) or vitreomacular interface abnormalities in the study eye, including but not limited to intravitreal therapy (faricimab, other anti-VEGF agents, corticosteroids, tissue plasminogen activator, ocriplasmin, C3F8 gas, air), periocular pharmacological interventions, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical procedures.\n12. Presence of glaucoma in the study eye with uncontrolled intraocular pressure ≥25 mmHg despite pharmacological therapy.\n13. Presence of active ocular inflammation or suspected or active ocular or periocular infection in either eye at screening.","locations":[{"facility":"Seoul National University Bundang Hospital","city":"Seongnam","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyung Hee University Medical Center","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Junyeop Lee, PhD","phone":"82-2-3010-3975","email":"j.lee.amc@gmail.com"}],"primaryOutcomes":["ANG-2 level in aqueous humour (AH)"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["seongnam-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 4: testing Faricimab Injection [Vabysmo] for Macular Degeneration","inPlainEnglish":"If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected.","whoItsFor":["Ages 50 Years to any","Male or female adults aged 50 years or older at the time of consent","Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol","Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening","Confirmed diagnosis, by the investigator, of active nAMD based on sufficiently clear ocular media and adequate pupillary dilation allowing acquisition of good quality retinal images for confirmation","Treatment naïve patients","For PCV patients, presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy","For PCV patients, greatest liner dimension (GLD) of the total lesion area \\<5400 μm as delineated by ICGA"],"whoShouldSkip":["Any major illness or major surgical procedure within 1 month before screening","History of active cancer within 12 months prior to screening, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 (Grade Group 1) and stable PSA levels for \\>12 months","Uncontrolled blood pressure, defined as systolic \\>180 mmHg and/or diastolic \\>100 mmHg while at rest at baseline. A repeat reading within the screening window may be taken to confirm eligibility","Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH)","Systemic treatment for suspected or active systemic infection at screening. Ongoing prophylactic antibiotic use may be acceptable at the investigator's discretion","Use of systemic medications known to have toxic effects on the lens, retina, or optic nerve within 6 months prior to screening or within 5 drug half-lives (whichever is longer), or expected future use of such medications","Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer)"],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 64 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.131Z"},{"nctId":"NCT07369011","title":"A Study of Eloralintide (LY3841136) in Participants With Obstructive Sleep Apnea and Obesity or Overweight","officialTitle":"A Master Protocol for Phase 3 Randomized, Double-Blind, Placebo-Controlled Studies to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Moderate to Severe Obstructive Sleep Apnea, and Obesity or Overweight","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of the studies is to evaluate the efficacy and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight. YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2. Study YSA1 will include participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy and study YSA2 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.\n\nParticipants will be assigned to the Intervention-Specific Appendix (ISA) that reflects their current PAP usage. Participation in the study will last about 76 weeks.","conditions":["Sleep Apnea, Obstructive","Obesity","Overweight"],"keywords":[],"interventions":[{"type":"DRUG","name":"Eloralintide"},{"type":"DRUG","name":"Placebo"}],"enrollment":800,"startDate":"2026-02-10","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed history of moderate-to-severe OSA\n* Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening\n* Have a BMI ≥27 kg/m2 at screening\n* Have a stable body weight (\\<5% body weight change) for 90 days prior to screening\n* Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight\n\nFor YSA1 Participants:\n\n* Are unable or unwilling to use PAP therapy\n\nFor YSA2 Participants:\n\n* Have been on PAP therapy for at least three consecutive months prior to screening and plan to continue PAP therapy during the study\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening\n* Have type 1 diabetes, type 2 diabetes, or any other type of diabetes\n* Have had within 90 days prior to screening:\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening","locations":[{"facility":"Cullman Clinical Trials","city":"Cullman","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - 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YDAO is a master protocol designed to support two independent studies: YSA1 and YSA2.","whoItsFor":["Ages 18 Years to any","Confirmed history of moderate-to-severe OSA","Have an AHI ≥ 15 on polysomnography (PSG) as part of the study at screening","Have a body-mass index (BMI) ≥27 kg/m2 at screening","Have a stable body weight (\\<5% body weight change) for 90 days prior to screening","Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight","For YSA1 Participants:","Are unable or unwilling to use PAP therapy"],"whoShouldSkip":["Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)","Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)","Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery that still may affect breathing at time of screening","Have type 1 diabetes, type 2 diabetes, or any other type of diabetes","Have had within 90 days prior to screening:","acute myocardial infarction","cerebrovascular accident (stroke)"],"whatHappens":"If you join, the listed intervention(s) are Eloralintide, or Placebo. The registry lists allocation as randomized. The purpose of the studies is to measure the how well it works and safety of eloralintide in participants with moderate-to-severe obstructive sleep apnea and obesity or overweight.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 800 people at 115 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.942Z"},{"nctId":"NCT07371338","title":"Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients","officialTitle":"Dose-Escalation, Single-Center, Open-label Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Adeno-associated Virus(AAV) Gene Therapy Product IPS101A in Parkinson's Disease Patients With Hoehn-Yahr Stage 4-5, Diagnosed in More Than 10 Years and Uncontrolled by All Available Monotherapy or Combination Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Innopeutics Corporation","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the dose-related safety and tolerability of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \\& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available monotherapy and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary efficacy and pharmacokinetic (PK) characteristics.","conditions":["Parkinson Disease","Parkinson's Disease"],"keywords":["PD","AAV","Adeno-associated Virus","Gene therapy"],"interventions":[{"type":"DRUG","name":"IPS101A"}],"enrollment":6,"startDate":"2026-05-13","completionDate":"2028-06-30","sex":"ALL","minAge":"50 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Subjects who have a diagnosis of Parkinson's disease that meets the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria at the time of the Screening Visit.\n2. Male or female subjects aged 50 to 80 years (inclusive) at the time of providing written informed consent, with a documented diagnosis of Parkinson's disease.\n3. Subjects with a duration of Parkinson's disease of at least 10 years prior to the Screening Visit, based on medical history and/or medical records.\n4. Subjects with Parkinson's disease that is inadequately controlled despite all available standard-of-care treatments, including monotherapy or combination therapy, as determined by the Investigator.\n5. Subjects with a Hoehn \\& Yahr stage of 4 or 5 in the off state at the Screening Visit.\n\nExclusion Criteria:\n\n1. Subjects with Parkinson's disease dementia (PDD) who meet the diagnostic criteria established by the Movement Disorder Society (MDS) Task Force, as determined by the Investigator at Screening.\n2. Subjects with a Korean Mini-Mental State Examination (K-MMSE) score ≤ 24 at the Screening assessment.\n3. Subjects in whom imaging findings suggestive of Parkinsonism-plus syndrome are observed on PET and MRI performed at the Screening Visit, as assessed by the Investigator and/or a qualified imaging specialist.\n4. Subjects who do not meet the diagnostic criteria for Parkinson's disease dementia but present with major visual hallucinations, as judged by the Investigator.\n5. Subjects with drug-induced parkinsonism, confirmed by clinical history and/or medical records, and determined by the Investigator.\n6. Subjects who are judged by the investigator to be unsuitable for participation in this clinical trial.","locations":[{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ChoLong Park","phone":"+82-2-3499-4266","email":"clpark@innopeutics.com"},{"name":"Tae-gyun Kim","phone":"","email":"contact@innopeutics.com"}],"primaryOutcomes":["Safety Evaluation: dose-limiting toxicity (DLT)","Safety Evaluation: Severity and frequency of reported adverse events","Safety Evaluation: clinically-relevant changes in laboratory testing assessed by medical personnel","Safety Evaluation: clinically-relevant changes in physical exams assessed by medical personnel"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing IPS101A for Parkinson Disease","inPlainEnglish":"This study wants to measure the dose-related whether it is safe and how hard side effects are to live with of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \\& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available this drug alone and combination therapy options. In addition, the study aims to assess the maximum tolerated dose (MTD) of IPS101A, as well as its preliminary how well it works and pharmacokinetic (PK) characteristics.","whoItsFor":["Ages 50 Years to 80 Years","Subjects who have a diagnosis of Parkinson's disease that meets the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria at the time of the Screening Visit","Subjects with a duration of Parkinson's disease of at least 10 years prior to the Screening Visit, based on medical history and/or medical records","Subjects with Parkinson's disease that is inadequately controlled despite all available standard-of-care treatments, including this drug alone or combination therapy, as determined by the Investigator","Subjects with a Hoehn \\& Yahr stage of 4 or 5 in the off state at the Screening Visit"],"whoShouldSkip":["Subjects with Parkinson's disease dementia (PDD) who meet the diagnostic criteria established by the Movement Disorder Society (MDS) Task Force, as determined by the Investigator at Screening","Subjects with a Korean Mini-Mental State Examination (K-MMSE) score ≤ 24 at the Screening assessment","Subjects in whom imaging findings suggestive of Parkinsonism-plus syndrome are observed on PET and MRI performed at the Screening Visit, as assessed by the Investigator and/or a qualified imaging specialist","Subjects who do not meet the diagnostic criteria for Parkinson's disease dementia but present with major visual hallucinations, as judged by the Investigator","Subjects with drug-induced parkinsonism, confirmed by clinical history and/or medical records, and determined by the Investigator","Subjects who are judged by the investigator to be unsuitable for participation in this clinical trial"],"whatHappens":"If you join, the listed intervention(s) are IPS101A. The registry lists allocation as randomized. This study wants to measure the dose-related whether it is safe and how hard side effects are to live with of IPS101A, an adeno-associated virus (AAV) gene therapy, in patients with Parkinson's disease who exhibit severe functional impairment corresponding to Hoehn \\& Yahr stages 4-5 and whose symptoms are not adequately controlled despite all available this drug alone and combination therapy options.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 6 people at Seoul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.669Z"},{"nctId":"NCT07372599","title":"Influence of Therapeutic Failure on the Psychosocial Experience in Multiple Sclerosis","officialTitle":"Influence of Therapeutic Failure on the Psychosocial Experience of Patients With Relapsing-remitting Multiple Sclerosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Caen","sponsorClass":"OTHER","summary":"Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole. Early initiation of disease-modifying therapy (DMT) is recommended in relapsing-remitting MS (RRMS). Nevertheless, according to a recent French cohort, 30% of patients initially treated with a first-line FT will switch to a highly effective compound within 5 years due to its ineffectiveness. Therapeutic failure (Th-F) is therefore a frequent occurrence, but its psychological, social and economic consequences are poorly understood. These elements are generally the subject of measurements reported by patients, and several studies have highlighted the importance of taking them into account in the management of these patients.\n\nHere, the investigators will study two categories of these measures in a Th-F situation. On the one hand, patient-reported outcome measurements (PROMs) will be examined. Patients' psychological distress and their QoL are two important examples of psychosocial impacts in patients with MS, compared to the general population. The impact on activity levels is also well known, but the specific effect of Th-F has not yet been studied. On the other hand, patients' experiences of their care pathway and their opinion on the quality of care (patient-reported experience measurement \\[PREM\\]) will also be studied. Some PREMs refer to care coordination, satisfaction with the relationship with carers or doctors' empathy levels. To date, data on the experience of MS patients regarding their care pathway remains limited and non-existent during Th-F.\n\nFinally, the influence of socioeconomic status (SES) on PROMs and PREMs is worth considering. In the general population, patients' experience of care can be influenced by their socioeconomic status. Compared with research on other diseases (notably cardiovascular diseases and cancers), there is relatively little work on the association between socioeconomic status and MS and none has focused on the topic of Th-F.\n\nThe investigators therefore hypothesise that a quality of care perceived favourably by MS patients may moderate the negative impact of Th-F on their QoL, anxiety/depression and activity levels (as recently described in oncology), and a more recent measure of abilities assessing well-being defined in a broad sense, as a function of their SES.","conditions":["Multiple Sclerosis"],"keywords":["Patient-reported-outcome","Patient-reported-experience","Quality of life","Socioeconomic status","Therapeutic failure","Multiple sclerosis"],"interventions":[{"type":"OTHER","name":"Questionnaires"}],"enrollment":150,"startDate":"2026-06-10","completionDate":"2029-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged 18 or over.\n* Patient with RRMS according to McDonald 2024 criteria.\n* Uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months.\n* Collection of non-objection.\n* Patient affiliated to the social security system.\n\nExclusion Criteria:\n\n* Patient with progressive MS.\n* Patient treated continuously with the same DMT for 3 years or more.\n* Patient who received a second line DMT or an immunosuppressant before taking a first line DMT.\n* Patients who have received mitoxantrone as the first treatment\n* Pregnant or breast-feeding woman at the time of inclusion.\n* Severe cognitive and/or psychological disorders which, according to the investigator (with or without a neuropsychological assessment), prevent the participant from completing the self-questionnaires independently and accurately.","locations":[{"facility":"CHU de Caen Normandie","city":"Caen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Groupement des Hôpitaux de l'Institut Catholique de Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Rouen","city":"Rouen","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pierre Branger, MD","phone":"+33231064617","email":"branger-p@chu-caen.fr"}],"primaryOutcomes":["Quality of life : The International Multiple Sclerosis Quality of Life Questionnaire (MusiQoL)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als","depression"],"drugSlugs":[],"locationSlugs":["caen-france","lille-france","rouen-france"],"enrichment":{"headline":"Not a traditional drug phase: Questionnaires for Multiple Sclerosis","inPlainEnglish":"Multiple sclerosis (MS), an inflammatory, neurodegenerative disease of the central nervous system, affects around 120,000 patients in France and is the leading cause of non-traumatic disability in young adults. It affects patients' health-related quality of life (QoL) and has a significant economic impact on patients and society as a whole.","whoItsFor":["Ages 18 Years to any","Patient aged 18 or over","Patient with RRMS according to McDonald 2024 criteria","Uninterrupted use of a moderately effective treatment, or highly effective treatment only if it is the first DMT, for at least 6 months","Collection of non-objection","Patient affiliated to the social security system"],"whoShouldSkip":["Patient with progressive MS","Patient treated continuously with the same DMT for 3 years or more","Patient who received a second line DMT or an immunosuppressant before taking a first line DMT","Patients who have received mitoxantrone as the first treatment","Pregnant or breast-feeding woman at the time of inclusion","Severe cognitive and/or psychological disorders which, according to the investigator (with or without a neuropsychological assessment), prevent the participant from completing the self-questionnaires independently and accurately"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.967Z"},{"nctId":"NCT07374640","title":"Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness","officialTitle":"Virtual Reality and Biofeedback for Adolescents With Chronic Dizziness","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Boston Children's Hospital","sponsorClass":"OTHER","summary":"Both persistent postural-perceptual dizziness (PPPD) and vestibular migraine (VM) are common diagnoses in patients presenting to physicians for evaluation of vestibular symptoms such as dizziness and vertigo. Although they are most often described in the adult population, they are also common in children and adolescents with dizziness. Chronic dizziness profoundly affects quality of life, often keeping children out of school and inhibiting their participation in the normal activities of childhood and adolescence. Overall, chronic dizziness is suspected to be due in large part to a \"rewiring\" of the brain that alters how cues related to balance and orientation are processed, with overreliance on visual inputs to maintain balance and equilibrium being a common development. Thus, chronic dizziness, especially that which is due to PPPD, is often caused by visual triggers.\n\nA multi-modal approach is often taken to treat chronic dizziness, attempting to recalibrate this maladaptive \"rewiring\" and return the sensory system to normal function. Given the role that visual inputs play in developing and perpetuating chronic dizziness, habituation to visual stimuli should be a significant component to treatment. Treatments often include cognitive behavioral therapy (CBT), systematic desensitization exposure response prevention (SDERP), and biofeedback therapy (BFB). However, these visually provoked symptoms are often resistant to treatment. One reason for this may be that visual stimuli are difficult to replicate in the clinic or office. One way to address this gap in treatment is through virtual reality (VR) technology, which immerses patients in realistic visual environments.\n\nVR has not been explicitly described in the treatment of PPPD or chronic dizziness, but it has been piloted, and shown to be effective, in the rehabilitation of peripheral vestibular dysfunction. This study aims to integrate VR into the current PPPD/chronic dizziness techniques of CBT, SDERP, and BFB. The investigators will use a commercially available VR headset, which enables the use of VR in the office setting in a relatively low-cost form of VR technology. This study will evaluate the feasibility and effectiveness of VR in conjunction with CBT, SDERP, and BFB to investigate if VR technology enhances previously established effective treatments to reduce chronic dizziness and PPPD.","conditions":["Persistent Postural Perceptual Dizziness","Vestibular Migraine","Chronic Dizziness"],"keywords":["Persistent Postural-Perceptual Dizziness","Vestibular Migraine","Chronic Dizziness","Virtual Reality","Biofeedback"],"interventions":[{"type":"DEVICE","name":"Virtual Reality"}],"enrollment":12,"startDate":"2026-08-03","completionDate":"2027-03","sex":"ALL","minAge":"13 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Patients who previously or are currently seen in our program who have not already undergone BFB, CBT, and SDERP for treatment of their chronic dizziness.\n\nExclusion Criteria:\n\n* Patients without chronic dizziness.\n* Patients for whom written consent is not available.\n* Patients who exhibit psychotic features, have untreated mental health conditions, or have an intellectual disability, developmental delay, or decisional impairment.\n* Non-English language preference patients.\n* Patients with a history of seizures, at risk of seizures, or who have a diagnosis of epilepsy.","locations":[{"facility":"Boston Children's Hospital at Waltham","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jacob R Brodsky, MD","phone":"781-216-2849","email":"jacob.brodsky@childrens.harvard.edu"},{"name":"Kyle K Pandiscio, BS","phone":"781-216-1633","email":"kyle.pandiscio@childrens.harvard.edu"}],"primaryOutcomes":["Dizziness Handicap Inventory","Nijmegen Questionnaire","Pediatric Quality of Life Inventory","Fear of Pain Questionnaire","Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Measure","Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Measure","Niigata PPPD Questionnaire"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["waltham-massachusetts"],"enrichment":{"headline":"Early phase 1: Virtual Reality for Persistent Postural Perceptual Dizziness","inPlainEnglish":"Both persistent postural-perceptual dizziness (PPPD) and vestibular migraine (VM) are common diagnoses in patients presenting to physicians for evaluation of vestibular symptoms such as dizziness and vertigo. Although they are most often described in the adult population, they are also common in children and adolescents with dizziness.","whoItsFor":["Ages 13 Years to 25 Years","\\- Patients who previously or are currently seen in our program who have not already undergone BFB, CBT, and SDERP for treatment of their chronic dizziness"],"whoShouldSkip":["Patients without chronic dizziness","Patients for whom written consent is not available","Patients who exhibit psychotic features, have untreated mental health conditions, or have an intellectual disability, developmental delay, or decisional impairment","Non-English language preference patients","Patients with a history of seizures, at risk of seizures, or who have a diagnosis of epilepsy"],"whatHappens":"If you join, the listed intervention(s) are Virtual Reality. The registry lists allocation as na. Both persistent postural-perceptual dizziness (PPPD) and vestibular migraine (VM) are common diagnoses in patients presenting to physicians for evaluation of vestibular symptoms such as dizziness and vertigo.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at Waltham. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.301Z"},{"nctId":"NCT07376772","title":"Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study","officialTitle":"Feasibility, Preliminary Efficacy, and User Perspective Usability of Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Florida","sponsorClass":"OTHER","summary":"This pilot mixed-method study will evaluate the feasibility, preliminary efficacy, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.","conditions":["Multiple Sclerosis (MS) - Relapsing-remitting","Upper Extremity Dysfunction"],"keywords":["focal vibration therapy","multiple sclerosis","upper extremity function","wearable","feasbility"],"interventions":[{"type":"DEVICE","name":"wearable focal vibration therapy"}],"enrollment":15,"startDate":"2026-03-04","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged over 18 years\n* Confirmed diagnosis of RRMS according to the McDonald criteria (33)\n* No MS relapse or exacerbation within the past 6 months (ensuring stability of symptoms)\n* Self-report on clinical evidence of UEx impairment (including reduced arm/hand function, muscle weakness, spasticity, or pain).\n* Stable on MS treatment for at least four weeks before recruitment, with no plans to initiate new treatments (participants may continue current treatments during the study)\n* Agree and are able to use the FVT device after training.\n* Sufficient proficiency in English to participate in interviews and follow instructions\n* Able to visit the laboratory for assessments\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) \\< 12)\n* Comorbid neurological or psychiatric conditions affecting the UEx (including stroke and severe carpal tunnel syndrome) that would confound results or make FVT unsafe\n* Unstable cardiac disease or any major medical illness that would preclude participation\n* Any known contraindications to vibration therapy (pregnancy, acute deep vein thrombosis, severe osteoporosis, chronic migraines, epilepsy, active malignancy in the target area, unstable cardiac disease, or an implanted pacemaker without clearance)","locations":[{"facility":"Norman Fixel Institute for Neurological Diseases","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hongwu Wang, PhD","phone":"352-273-9934","email":"hongwu.wang@ufl.edu"}],"primaryOutcomes":["Nine-Hole Peg Test (9HPT)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["gainesville-florida"],"enrichment":{"headline":"Not a traditional drug phase: wearable focal vibration therapy for Multiple Sclerosis (MS) - Relapsing-remitting","inPlainEnglish":"This pilot mixed-method study will measure the feasibility, preliminary how well it works, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.","whoItsFor":["Ages 18 Years to 100 Years","Confirmed diagnosis of RRMS according to the McDonald criteria (33)","No MS relapse or exacerbation within the past 6 months (ensuring stability of symptoms)","Self-report on clinical evidence of UEx impairment (including reduced arm/hand function, muscle weakness, spasticity, or pain)","Stable on MS treatment for at least four weeks before recruitment, with no plans to initiate new treatments (participants may continue current treatments during the study)","Agree and are able to use the FVT device after training","Sufficient proficiency in English to participate in interviews and follow instructions","Able to visit the laboratory for assessments"],"whoShouldSkip":["Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) \\< 12)","Comorbid neurological or psychiatric conditions affecting the UEx (including stroke and severe carpal tunnel syndrome) that would confound results or make FVT unsafe","Unstable cardiac disease or any major medical illness that would preclude participation","Any known contraindications to vibration therapy (pregnancy, acute deep vein thrombosis, severe osteoporosis, chronic migraines, epilepsy, active malignancy in the target area, unstable cardiac disease, or an implanted pacemaker without clearance)"],"whatHappens":"If you join, the listed intervention(s) are wearable focal vibration therapy. The registry lists allocation as na. This pilot mixed-method study will measure the feasibility, preliminary how well it works, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 15 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.975Z"},{"nctId":"NCT07378644","title":"Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","officialTitle":"A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Skyhawk Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.","conditions":["Huntington Disease"],"keywords":["SKY-0515","Skyhawk","HTT","Neurodegenerative","Huntington Disease","mRNA","Splicing","Mutant Huntingtin protein"],"interventions":[{"type":"DRUG","name":"SKY-0515"},{"type":"DRUG","name":"SKY-0515 Placebo"}],"enrollment":400,"startDate":"2026-01-06","completionDate":"2028-12","sex":"ALL","minAge":"25 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 25 years or older.\n* Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more).\n* Total Functional Capacity (TFC) score of 10 or more).\n* Total Motor Score (TMS) of 6 or more).\n* Independence Score (IS) of 70 or more).\n* Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug.\n* Men must agree to use birth control during the study and for 90 days after the last dose.\n* Agree to sign a consent form and follow the study's rules and schedule.\n\nExclusion Criteria:\n\n* Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe.\n* Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI.\n* Cancer, except for some types of skin cancer, or a history of cancer in the last five years.\n* Severe allergies or have reacted badly to similar drugs in the past.\n* Taking medications or treatments that might interfere with the study.\n* Participated in another study or taken experimental drugs in the last two months (or longer for some drugs).\n* Any kind of gene therapy.\n* History of suicidal thoughts, severe depression, or have attempted suicide in the past year.\n* Liver function tests show significant abnormalities.\n* Positive for hepatitis B, hepatitis C, or HIV.\n* Pregnancy, breastfeeding, or planning to become pregnant during the study.","locations":[{"facility":"CenExel Denver CO","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Charlestown","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital El Cruce","city":"Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Buenos Aires British Hospital","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"IADIN (Instituto Argentino de Investigación Neurológica)","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"CINME Centro de Investigaciones Metabólicas","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Mater Dei","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Scherbovsky","city":"Mendoza","state":"Mendoza Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH","city":"Belo Horizonte","state":"Minas Gerais","country":"Brazil","status":"ENROLLING_BY_INVITATION","lat":null,"lon":null},{"facility":"Hospital Angelina Caron","city":"Campina Grande do Sul","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Neurologia de Curitiba","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Pedro Ernesto (HUPE)","city":"Rio de Janeiro","state":"Rio de Janiero","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitário Onofre Lopes (HUOL)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Faculdade de Medicina de Ribeirão Preto - FMRP","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital da Universidade Federal de São Paulo - UNIFESP","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"PSEG Centro de Pesquisa Clinica","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"North York General Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Católica de Chile","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"CETRAM (Centro de Trastornos del Movimiento)","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica de la Costa S.A.S","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pineo Medical Ecosystem","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Simon Khechinashvili University Hospital","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Isar-Amper-Klinikum, Zentrum für Neuro- und Gerontopsychiatrie (ZNGP)","city":"Taufkirchen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal","city":"Madrid","state":"Madrid","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sant Pau Hospital","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NeuroClnx","city":"Motherwell","state":"Lanarkshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College of London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director, MD","phone":"6178580041","email":"sky0515trials@skyhawktx.com"}],"primaryOutcomes":["Change From Baseline in the Z-score from the Composite Unified Huntington's Disease Rating Scale (cUHDRS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["englewood-colorado","boston-massachusetts","charlestown-massachusetts","columbus-ohio","buenos-aires-argentina","caba-argentina","mendoza-argentina","belo-horizonte-brazil","campina-grande-do-sul-brazil","curitiba-brazil","rio-de-janeiro-brazil","natal-brazil","ribeir-o-preto-brazil","s-o-paulo-brazil","toronto-canada","santiago-chile","barranquilla-colombia","tbilisi-georgia","taufkirchen-germany","madrid-spain","barcelona-spain","motherwell-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2 / Phase 3: testing SKY-0515 for Huntington Disease","inPlainEnglish":"The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD. This study includes men and women aged 25 and older who have HD confirmed by genetic testing and meet certain requirements for physical ability and independence.","whoItsFor":["Ages 25 Years to any","Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more)","Total Functional Capacity (TFC) score of 10 or more)","Total Motor Score (TMS) of 6 or more)","Independence Score (IS) of 70 or more)","Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug","Men must agree to use birth control during the study and for 90 days after the last dose","Agree to sign a consent form and follow the study's rules and schedule"],"whoShouldSkip":["Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe","Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI","Cancer, except for some types of skin cancer, or a history of cancer in the last five years","Severe allergies or have reacted badly to similar drugs in the past","Taking medications or treatments that might interfere with the study","Participated in another study or taken experimental drugs in the last two months (or longer for some drugs)","Any kind of gene therapy"],"whatHappens":"If you join, the listed intervention(s) are SKY-0515, or SKY-0515 Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to test if the drug SKY-0515, an oral medication, can lower harmful proteins linked to Huntington's Disease (HD) and improve the symptoms of participants with HD.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 400 people at 31 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.010Z"},{"nctId":"NCT07379827","title":"Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)","officialTitle":"Effectiveness and Adverse-effect Switch Evaluation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States","conditions":["Schizophrenia"],"keywords":["Schizophrenia"],"interventions":[{"type":"DRUG","name":"Xanomeline and trospium chloride (KarXT)"}],"enrollment":1500,"startDate":"2026-02-26","completionDate":"2028-06-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.\n* Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.\n* Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:\n\n  * Be within \\<16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR\n  * On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.\n* Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.\n\nExclusion Criteria:\n\n* Prior use of KarXT that has been discontinued for any reason prior to Baseline.\n* Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.\n* Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.\n* In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are \\< 16 weeks from initiation of KarXT.\n* Participants who are pregnant, planning to become pregnant, or breastfeeding.","locations":[{"facility":"SanRo Clinical Research Group","city":"Bryant","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pamoja Advanced Nursing Practice","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0003","city":"Anaheim","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group (IPMG)-Chino","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0012","city":"La Palma","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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0059","city":"Hartford","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Envision Trials LLC","city":"Bonita Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Galiz Research","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0030","city":"Homestead","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"New Access Research & Medical Services Inc - Kendall","city":"Kendall","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0032","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Banyan Behavioal Care Program - CSU","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0007","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"BioResearch Partner - Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Research of Central Florida","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0040","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emory University.","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avant Psychiatry","city":"Austell","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0044","city":"Marietta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,500 people at 68 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.042Z"},{"nctId":"NCT07380711","title":"Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outcomes","officialTitle":"Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.","conditions":["Chronic Obstructive Pulmonary Disease COPD"],"keywords":[],"interventions":[],"enrollment":500,"startDate":"2026-01-28","completionDate":"2030-08-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.\n* Adult patients.\n* Patients with uncontrolled Chronic Obstructive Pulmonary Disease (COPD) despite long-acting muscarinic antagonist (LAMA)/ Long-acting beta2-agonist (LABA)/ Inhaled Corticosteroid (ICS) (or LAMA/LABA if ICS are not appropriate) therapy and elevated blood eosinophils (a blood eosinophil count ≥ 300 cells/microL).\n* Patients newly initiated on dupilumab treatment as indicated in the dupilumab summary of product characteristics (SmPC) in the specified label for COPD, determined by the treating physician, and independent of participation in the non-interventional study (NIS).\n\nExclusion Criteria:\n\n* Patient not eligible for dupilumab treatment according to SmPC.\n* Participation in an ongoing interventional study or participation in an interventional study up to 12 months before enrolment that might, in the treating physician's opinion, influence the assessments for the current study.\n* Any acute or chronic condition that, in the treating physician's opinion, would limit the patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number : 2500021","city":"Aix-en-Provence","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500022","city":"Antibes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500043","city":"Blois","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500044","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500009","city":"Colmar","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500031","city":"Contamine-sur-Arve","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500046","city":"Évreux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500003","city":"La Tronche","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500020","city":"Le Chesnay","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500038","city":"Libourne","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500006","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500005","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500033","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500024","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500002","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500047","city":"Morlaix","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500040","city":"Niort","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500026","city":"Nîmes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500007","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500017","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500001","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500034","city":"Pierre-Bénite","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500004","city":"Reims","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500048","city":"Saint-Denis","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500028","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500029","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500010","city":"Vantoux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2500035","city":"Villeurbanne","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Descriptive statistical analysis of socio-demographics","Descriptive statistical analysis of medical disease","Descriptive statistical analysis of treatment history","Descriptive statistical analysis of clinical disease characteristics (symptoms)","Descriptive statistical analysis of clinical disease characteristics (exacerbations)","Descriptive statistical analysis of clinical disease characteristics (lung function parameters)","Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])","Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)","Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)","Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group)","Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))","Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)","Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)","Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)","Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)","Date of COPD diagnosis and GOLD grade/group at COPD diagnosis","Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)","Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)","Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).","Descriptive statistical analysis of Vaccine status.","Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":["dupilumab"],"locationSlugs":["aix-en-provence-france","antibes-france","blois-france","brest-france","colmar-france","contamine-sur-arve-france","vreux-france","la-tronche-france","le-chesnay-france","libourne-france","lille-france","lyon-france","marseille-france","montpellier-france","morlaix-france","niort-france","n-mes-france","paris-france","pessac-france","pierre-b-nite-france","reims-france","saint-denis-france","toulouse-france","vantoux-france","villeurbanne-france"],"enrichment":{"headline":"Long-term Real-world Study of Dupilumab in COPD : Patient Characteristics, Safety and Patient-reported Outc…","inPlainEnglish":"The OBS19236 is a retrospective and prospective, non-treatment watch-and-measure (no experimental treatment required) study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.","whoItsFor":["Ages 18 Years to any","Patients newly initiated on dupilumab treatment as indicated in the dupilumab summary of product characteristics (SmPC) in the specified label for COPD, determined by the treating physician, and independent of participation in the non-treatment study (NIS)"],"whoShouldSkip":["Patient not eligible for dupilumab treatment according to SmPC","Participation in an ongoing treatment study or participation in an treatment study up to 12 months before enrolment that might, in the treating physician's opinion, influence the assessments for the current study","Any acute or chronic condition that, in the treating physician's opinion, would limit the patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 28 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.709Z"},{"nctId":"NCT07382323","title":"Metacognitive Therapy Compared to Cognitive-behavioral Therapy","officialTitle":"Transdiagnostic Metacognitive Therapy Compared to Disorder-specific Cognitive-behavioral Therapy for Anxiety Disorders: a Qualitative Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Karolinska Institutet","sponsorClass":"OTHER","summary":"This is a qualitative study of participants who have taken part in a randomized controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.","conditions":["Generalized Anxiety Disorder","Social Anxiety Disorder","Posttraumatic Stress Disorder (PTSD)"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Transdiagnostic metacognitive therapy"},{"type":"BEHAVIORAL","name":"Disorder-specific cognitive-behavioral therapy"}],"enrollment":30,"startDate":"2026-01-28","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older,\n* A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,\n* No change in dose during the last six weeks if on pharmacological treatment, and\n* Ability to read and speak Swedish.\n\nExclusion Criteria:\n\n* A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,\n* Acute suicide risk, or\n* Concurrent psychological treatment.","locations":[{"facility":"Northern Stockholm Psychiatry Clinic","city":"Stockholm","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Benjamin Bohman","phone":"0701713443","email":"benjamin.bohman@ki.se"},{"name":"Nathalie Petersén","phone":"0762082221","email":"nathalie.petersen@ki.se"}],"primaryOutcomes":["Qualitative interview data"],"hasResults":false,"conditionSlugs":["ptsd","anxiety"],"drugSlugs":[],"locationSlugs":["stockholm-sweden"],"enrichment":{"headline":"Not a traditional drug phase: Transdiagnostic metacognitive therapy for Generalized Anxiety Disorder","inPlainEnglish":"This is a qualitative study of participants who have taken part in a randomly assigned controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders. The purpose of the study is to explore participant perceptions of the respective treatment models to facilitate implementation and dissemination of the treatments.","whoItsFor":["Ages 18 Years to any","Age 18 years or older,","A principal diagnosis of generalized anxiety disorder, social anxiety disorder, or posttraumatic stress disorder,","No change in dose during the last six weeks if on pharmacological treatment, and","Ability to read and speak Swedish"],"whoShouldSkip":["A current diagnosis of psychotic disorder, bipolar disorder, neurocognitive disorder, or moderate to severe substance use disorder,","Acute suicide risk, or","Concurrent psychological treatment"],"whatHappens":"If you join, the listed intervention(s) are Transdiagnostic metacognitive therapy, or Disorder-specific cognitive-behavioral therapy. The registry lists allocation as randomized. This is a qualitative study of participants who have taken part in a randomly assigned controlled trial comparing transdiagnostic metacognitive therapy and disorder-specific cognitive-behavioral therapy for anxiety disorders.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Stockholm. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.356Z"},{"nctId":"NCT07382596","title":"Cervical Plexus Hydrodissection With D5W Versus NS for Treatment-Resistant PTSD","officialTitle":"Cervical Plexus Hydrodissection With D5W Versus NS for Treatment-Resistant PTSD","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Dr. Dean Reeves Clinic","sponsorClass":"OTHER","summary":"PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and observational results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD. This randomized trial will compare dextrose injection with an injection control of normal saline (NS)","conditions":["PTSD"],"keywords":["Dextrose","Hydrodissection","Cervical Plexus"],"interventions":[{"type":"DRUG","name":"Dextrose 5% in water bilateral injection"},{"type":"DRUG","name":"Normal saline bilateral injection"}],"enrollment":50,"startDate":"2026-05-16","completionDate":"2030-03-01","sex":"ALL","minAge":"19 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion Criteria:\n* Not involved in another study of PTSD treatment\n* Reliable transportation\n* Comfortable with computers\n* Tried 2 or more medications for treatment of PTSD symptoms\n* Tried 2 or more non-medication treatments for PTSD symptom\n* No known life-threatening illness\n* Not taking daily narcotics\n* Not having 3 or more alcoholic drinks on an average day\n* No active suicidal plans\n* No major surgery plans\n* No major life stress that might interfere with completing study\n* Symptoms for more than 1 year\n* Not planning to move for next 18 months.\n* Living within an hour of Portland, OR, Madison, WI, or Lexington, KY\n* Wiling to provide 2 email and 2 phone contact methods\n* Willing to answer questions on multiple occasions over the course of a year.\n* Willing to be assigned to 3 months of usual care treatment\n* No diagnosis of schizophrenia, Borderline Personality Disorder, or Bipolar Disorder.\n* No severe needle phobia\n* Chronic pain ≤ 5/10\n* PCL-C score ≥ 50\n\nExclusion Criteria:\n\n\\-","locations":[{"facility":"Wellward Medical","city":"Lexington","state":"Kentucky","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NW Regen","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paul Johnson, MD.","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Procedures of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kenneth D Reeves, MD","phone":"9133621600","email":"DeanReevesmd@gmail.com"},{"name":"Clare R Solso, RN","phone":"405 819 7777","email":"cereeves2002@hotmail.com"}],"primaryOutcomes":["Post traumatic checklist for civilians"],"hasResults":false,"conditionSlugs":["depression","ptsd"],"drugSlugs":[],"locationSlugs":["lexington-kentucky","portland-oregon","madison-wisconsin"],"enrichment":{"headline":"Phase 4: testing Dextrose 5% in water bilateral injection for PTSD","inPlainEnglish":"PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and watch-and-measure (no experimental treatment required) results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD. This randomly assigned trial will compare dextrose injection with an injection control of normal saline (NS)","whoItsFor":["Ages 19 Years to 90 Years","who can join:","Not involved in another study of PTSD treatment","Reliable transportation","Comfortable with computers","Tried 2 or more medications for treatment of PTSD symptoms","Tried 2 or more non-medication treatments for PTSD symptom","No known life-threatening illness"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Dextrose 5% in water bilateral injection, or Normal saline bilateral injection. The registry lists allocation as randomized. PTSD is a chronic mental health condition that drastically reduces an individual's quality of life Dextrose injection with a small needle has been used for chronic pain patients and watch-and-measure (no experimental treatment required) results have shown it to be effective in reducing anxiety, brain fog, and depression in patients with PTSD.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 50 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.406Z"},{"nctId":"NCT07386730","title":"A Study of Psychedelics in Healthy Older Adults With Low Well-being","officialTitle":"A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Jennifer Mitchell","sponsorClass":"OTHER","summary":"This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being.\n\nThe main questions it aims to answer are, does psilocybin:\n\n1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology.\n2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology.\n3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI\n\nParticipants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below.\n\nResearchers will compare participants who receive the following drug options:\n\n* A low-to-moderate dose of Psilocybin (5-10 mg)\n* A moderate-to-high dose of Psilocybin (25-30 mg)\n* A low-to-moderate dose of Dextromethorphan (30-60 mg)\n* A moderate-to-high dose of Dextromethorphan (80-90 mg)","conditions":["Anhedonia in Healthy Volunteers","Older Adults (50-90 Years)"],"keywords":["Psilocybin","Dextromethorphan","older adults","well-being","EEG","MRI","neuroinflammation","Alzheimer's disease plasma markers","wearables"],"interventions":[{"type":"DRUG","name":"Psilocybin (drug)"},{"type":"DRUG","name":"Dextromethorphan (DXM)"}],"enrollment":80,"startDate":"2026-06-01","completionDate":"2030-02","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study.\n\nInclusion Criteria:\n\n* Are between 50-85 years inclusive at time of consent signing\n* Have below-average well-being, defined by the World Health Organization Well-Being Index (WHO-5)\n* Have no cognitive impairments, indicated by a Mini-Mental State Examination (MMSE) score \\>24\n* Have an identified willing contact person with at least weekly contact with the participant to be able to provide meaningful information about the participant's daily function and able to pick up the study participant at the end of the Dosing Visit\n* Participants assigned female sex at birth must be non-lactating, and post-menopausal, defined as a period of over 12 months since the last menstrual period, or otherwise physically unable to become pregnant\n* Participants assigned male sex at birth must 1) refrain from sperm donation for 3 months after the Dosing Visit, and 2) if engaging in sexual activities that may result in pregnancy, must use a condom, plus their partner of childbearing potential must use a second, highly effective form of contraception for 3 months after the Dosing Visit\n* Be proficient in English\n* Are able and willing to provide consent as assessed by comprehension questions in informed consent process\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Ability to swallow oral medications (capsules)\n\nExclusion Criteria:\n\nGeneral:\n\n* Have a known allergic or severe reaction to Psilocybin, Dextromethorphan, or any of the non-active components of the IMP capsules\n* Insufficient ability to report on symptoms to make a valid assessment on any required instrument\n* Have a condition or presence of clinical feature which, in the opinion of the investigators might interfere with or prevent appropriate study participation or interfere with data interpretation\n\nMRI Exclusions:\n\n* Any implanted object or device that poses a safety risk or could interfere with MRI scanning (e.g. aneurysm clips, cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, spinal cord stimulators, insulin or infusion pumps, metallic prostheses or fragments, heart valves, vascular stents, or shunts. surgical staples, clips, or joint replacements, radiation seeds, medication patches containing metal, or any other metallic or electronic implants)\n* History of metallic injury to the eyes or body, or those with tattoos containing metallic ink, permanent makeup, or body piercings that cannot be removed.\n* Any condition that poses a safety risk or could interfere with MRI scanning (e.g. severe claustrophobia or motion disorders or breathing problems, etc)\n\nPsychiatric:\n\n•History of hallucinogen persisting perception disorder (HPPD) (as per DSM-5 criteria)\n\nCardiovascular:\n\n* Clinically significant cardiovascular conditions e.g., clinically significant EKG abnormalities, transient ischemic attack in the last 6 months, history of hemorrhagic stroke, history of myocardial infarction within 1 year of signing informed consent form (ICF)\n* Baseline (heart rate \\< 60 bpm or \\> 90 bpm at screening or pre-dose\n* Baseline hypertension (≥140 SBP or ≥90 DBP), after repeated measurements\n* QTc Interval \\> 450msec on 12-lead EKG. Note: If QT-prolonging medications are started or increased in dose after enrollment and prior to dosing visit, a repeat EKG must be done \\>12-hours after this change to assure continued safe enrollment in the trial\n* Clinically significant arrhythmia (e.g., uncontrolled atrial fibrillation, or untreated supraventricular tachycardia)\n* Any current condition where physical activity is associated with palpitations, anginal pain or syncope\n\nGeneral health:\n\n* Major systemic disorders, including seizure, insulin dependent diabetes mellitus, recent history (last 12 months) of advanced cancer or its treatment (radiation therapy or chemotherapy), had major surgery within 6 months from screening or plans to have surgery while enrolled in the study\n* Inadequate hepatic function as determined by total bilirubin or alkaline phosphatase \\>3x institutional upper limit of normal; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \\>3x institutional upper limit of normal. However, participants with Gilbert syndrome are allowed to enroll\n* Inadequate renal function as determined by estimated glomerular filtration rate (eGFR) \\< 60 mL/min/1.73 m2 (based on the MDRD equation)\n* Participant is at increased risk of falls","locations":[{"facility":"University of California San Francisco, Sandler Neuroscience Building","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gabriella Mace","phone":"415-707-5399","email":"agingandpsychedelics@ucsf.edu"}],"primaryOutcomes":["Acute changes in EEG-based ESBA"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["psilocybin"],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Phase 1: testing Psilocybin (drug) for Anhedonia in Healthy Volunteers","inPlainEnglish":"This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1.","whoItsFor":["Ages 50 Years to 85 Years","The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study","Are between 50-85 years inclusive at time of consent signing","Have below-average well-being, defined by the World Health Organization Well-Being Index (WHO-5)","Have no cognitive impairments, indicated by a Mini-Mental State Examination (MMSE) score \\>24","Participants assigned female sex at birth must be non-lactating, and post-menopausal, defined as a period of over 12 months since the last menstrual period, or otherwise physically unable to become pregnant","Be proficient in English","Stated willingness to comply with all study procedures and availability for the duration of the study"],"whoShouldSkip":["Have a known allergic or severe reaction to Psilocybin, Dextromethorphan, or any of the non-active components of the IMP capsules","Insufficient ability to report on symptoms to make a valid assessment on any required instrument","Have a condition or presence of clinical feature which, in the opinion of the investigators might interfere with or prevent appropriate study participation or interfere with data interpretation","History of metallic injury to the eyes or body, or those with tattoos containing metallic ink, permanent makeup, or body piercings that cannot be removed","Any condition that poses a safety risk or could interfere with MRI scanning (e.g. severe claustrophobia or motion disorders or breathing problems, etc)","History of hallucinogen persisting perception disorder (HPPD) (as per DSM-5 criteria)","Baseline (heart rate \\< 60 bpm or \\> 90 bpm at screening or pre-dose"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (drug), or Dextromethorphan (DXM). The registry lists allocation as randomized. This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 80 people at San Francisco. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.104Z"},{"nctId":"NCT07386743","title":"A Phase III Study of GS101 Injection to Dupixent®","officialTitle":"A Multicenter, Randomized, Double-blinded, Parallel, Positive-controlled, Phase III Comparative Study to Evaluate GS101 Injection Versus Dupixent® in Participants With Moderate-to-Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Jiangsu Genscend Biopharmaceutical Co., Ltd","sponsorClass":"INDUSTRY","summary":"This is a a multicenter, randomized, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomized at a ratio of 1:1 to receive GS101 injection or Dupixent®","conditions":["Atopic Dermatitis (AD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"GS101 injection"},{"type":"DRUG","name":"DUPIXENT®"}],"enrollment":572,"startDate":"2026-01-29","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects, male or female, between the ages of 18 and 75 years (inclusive)\n* At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening\n* During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%.\n\nExclusion Criteria:\n\n* Hypersensitivity or known allergy to the investigational product(s) or any of their excipients\n* Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer\n* Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period","locations":[{"facility":"The First Hospital of China Medical University","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sinian Li, Master","phone":"+086-15800767550","email":"lisinian@jxingbio.com"},{"name":"Tao Sun, Master","phone":"+086-15921575347","email":"suntao@jxingbio.com"}],"primaryOutcomes":["Proportion of patients achieving EASI-75 at week 16"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["shenyang-china"],"enrichment":{"headline":"Phase 3: testing GS101 injection for Atopic Dermatitis (AD)","inPlainEnglish":"This is a a multicenter, randomly assigned, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis. A total of 572 subjects are planned to be included and randomly assigned at a ratio of 1:1 to receive GS101 injection or Dupixent®","whoItsFor":["Ages 18 Years to 75 Years","Subjects, male or female, between the ages of 18 and 75 years (inclusive)","At the time of screening, the diagnosis of atopic dermatitis (AD) meets the Hanifin-Rajka criteria, with a disease history for at least 1 year prior to screening","During the screening period and at baseline, patients with moderate-to-severe atopic dermatitis, defined as meeting all of the following 3 criteria concurrently: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA ≥ 10%"],"whoShouldSkip":["Hypersensitivity or known allergy to the investigational product(s) or any of their excipients","Treatment with any investigational drug, medical device, or other biologic agent within 8 weeks prior to randomization or within 5 half-lives (if the half-life is known), whichever is longer","Receipt of any live or live-attenuated vaccine within 3 months prior to randomization, or planned receipt of such vaccines during the study period"],"whatHappens":"If you join, the listed intervention(s) are GS101 injection, or DUPIXENT®. The registry lists allocation as randomized. This is a a multicenter, randomly assigned, double-blinded, parallel, positive-controlled, Phase III comparative study to evaluate GS101 Injection versus Dupixent® in participants with moderate-to-severe atopic dermatitis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 572 people at Shenyang. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.705Z"},{"nctId":"NCT07387900","title":"Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia","officialTitle":"Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Cairo University","sponsorClass":"OTHER","summary":"There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.\n\nWhile metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.","conditions":["Oral Leukoplakia"],"keywords":["Oral Leukoplakia","Metformin"],"interventions":[{"type":"DRUG","name":"Metformin Hydrochloride"},{"type":"DRUG","name":"Placebo"}],"enrollment":34,"startDate":"2026-07-05","completionDate":"2027-09","sex":"ALL","minAge":"21 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients over 21 years.\n* Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.\n* Lesions with mild to moderate degree of dysplasia.\n* Patients who agree to sign a written consent after understanding the nature of the study.\n\nExclusion Criteria:\n\n* Patients with lesions showing sever degree of dysplasia.\n* Patients who have cardiovascular, lung, Renal, Liver diseases\n* Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)\n* Patients on H2 blocker \\& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)\n* Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.\n* Patients on Retinoid, green tea supplements or another natural products therapy\n* Patients with other accompanying oral lesions\n* Pregnant or Lactating females","locations":[{"facility":"Cairo University","city":"Cairo","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mohamed Refaat Ghanem, MSc","phone":"+02 01221493237","email":"Mohamed-Refaat@dentistry.cu.edu.eg"}],"primaryOutcomes":["Change in lesion size"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["cairo-egypt"],"enrichment":{"headline":"Phase 2: testing Metformin Hydrochloride for Oral Leukoplakia","inPlainEnglish":"There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.","whoItsFor":["Ages 21 Years to any","Adult patients over 21 years","Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia","Lesions with mild to moderate degree of dysplasia","Patients who agree to sign a written consent after understanding the nature of the study"],"whoShouldSkip":["Patients with lesions showing sever degree of dysplasia","Patients who have cardiovascular, lung, Renal, Liver diseases","Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)","Patients on H2 blocker \\& proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)","Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use","Patients on Retinoid, green tea supplements or another natural products therapy","Patients with other accompanying oral lesions"],"whatHappens":"If you join, the listed intervention(s) are Metformin Hydrochloride, or Placebo. The registry lists allocation as randomized. There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 34 people at Cairo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.332Z"},{"nctId":"NCT07388563","title":"Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma","officialTitle":"A Phase I Trial of Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nT-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses). Azacitidine and abatacept are 2 drugs that are used to treat other diseases. Researchers want to know if these drugs, used together, can help people with T-cell lymphoma.\n\nObjective:\n\nTo learn if azacitidine combined with abatacept can shrink tumors in people with T-cell lymphoma.\n\nEligibility:\n\nPeople aged 18 years and older with T-cell lymphoma that either came back or did not respond to treatment.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have imaging scans of their tumors. A sample of tumor tissue may be taken.\n\nAzacitidine is injected under the skin of the thigh, abdomen, or upper arm. Abatacept is infused through a needle inserted into a vein in the arm.\n\nParticipants will receive the study drugs in 28-day cycles for up to 13 cycles. They will come to the clinic for each treatment. They will come to the clinic on day 1 and day 15 of the first cycle. After that, they will come to the clinic on the first 5 or 7 days of each cycle. Each clinic visit will take no more than 8 hours.\n\nImaging scans and other tests will be repeated during the study. Participants will have follow-up visits for up to 5 years after they stop taking the study drugs....","conditions":["Lymphoma, T Cell, Peripheral","T-cell Lymphoma","Angioimmunoblastic T-cell Lymphoma","Anaplastic Large Cell Lymphoma","Monomorphic Epitheliotropic Intestinal T-cell Lymphoma","Adult T-cell Leukemia/Lymphoma"],"keywords":["Selective Costimulation Modulators","Immunomodulators","Biological Therapy","Chemotherapy"],"interventions":[{"type":"DRUG","name":"azacitidine"},{"type":"DRUG","name":"abatacept"}],"enrollment":20,"startDate":"2026-03-26","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"-INCLUSION CRITERIA\n\n1. Participants must have a histologically or cytologically confirmed T-cell lymphoma confirmed by the Laboratory of Pathology (LP), NCI. The one of the following T-cell lymphomas are included:\n\n   * Peripheral T-cell lymphoma not otherwise specified (PTCL, NOS)\n   * Angioimmunoblastic T-cell lymphoma (AITL)\n   * T-follicular helper (TFH) lymphoma\n   * Anaplastic large cell lymphoma (ALCL)\n   * Enteropathy-associated T-cell lymphoma (EATL)\n   * Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)\n   * Adult T-cell leukemia/lymphoma (ATLL)\n   * Other T-cell lymphoma (TCL)\n2. Participants must have a disease that is relapsed or refractory after initial systemic treatment.\n3. Participants must have evaluable disease on screening imaging or by laboratory assessment.\n4. Age \\>= 18 years.\n5. ECOG performance status \\<= 2.\n6. Participants must have adequate organ and marrow function as defined below:\n\n   * Absolute neutrophil count (ANC) / \\>= 1,000 cells/mcL OR \\>= 500 cells/mcL if bone marrow involvement with lymphoma\n   * Platelets / \\>= 50,000 cells/mcL OR \\>= 25,000 cells/mcL if bone marrow involvement with lymphoma\n   * Hemoglobin / \\>= 8 g/dL (transfusions permitted)\n   * Renal function / Serum creatinine \\<= 2 mg/dL OR Glomerular filtration rate (GFR) \\>= 40 mL/min/1.73 m\\^2 as estimated by the Modification of Diet in Renal Disease (MDRD).\n\n   Note: there is no limit if involved by lymphoma.\n\n   If not on target, a 24-hour urine creatinine clearance can be used to directly measure creatinine clearance.\n   * Total bilirubin / \\<= 1.5 x upper limit of normal (ULN)\n   * Aspartate Aminotransferase (AST) / \\<= 3.0 x ULN\n   * Alanine Aminotransferase (ALT) / \\<= 3.0 x ULN\n   * Prothrombin time (PT) / \\<1.5 x ULN\n   * Activated partial thromboplastin time (aPTT) / \\<1.5 x ULN; \\< 5.0 x ULN if the aPTT is prolonged because of a positive Lupus Anticoagulant\n\n   International normalized ratio (INR) / \\<1.5 x ULN\n7. Participants, seropositive for human immunodeficiency virus (HIV), must have an undetectable HIV viral load.\n8. Participants, seropositive for hepatitis C virus (HCV) infection, must have been treated and have an undetectable HCV viral load.\n9. Participants who are hepatitis B core antibody (HBcAb) positive must have a hepatitis B virus (HBV) viral load result \\<100 IU/mL. Note: participants who are hepatitis B surface antigen (HBsAg) positive are excluded.\n10. Participants with detectable Epstein-Barr virus (EBV) or Cytomegalovirus (CMV) by polymerase chain reaction will be eligible provided they do not have end organ dysfunction from EBV or CMV infection.\n11. Participants with pulmonary disease such as chronic obstructive pulmonary disease and non-infectious liver disease who otherwise meet the requirements.\n12. Women of child-bearing potential (WOCBP) must agree to use effective methods of contraception (barrier, hormonal, surgical sterilization, abstinence) during the study treatment and for 6 months after the completion of the study treatment. Note: WOCBP is defined as any woman who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\n    Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) during the study treatment and for 3 months after the completion of the study treatment. These men must not freeze or donate sperm within the same period.\n13. Nursing participants must be willing to discontinue nursing from study treatment initiation through six (6) months after the last dose of the study drug(s).\n14. Ability of the participant to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria\n\n1. Any second malignancy that requires current active systemic therapy.\n2. Latent tuberculosis (TB) infection.\n3. Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation.\n4. Anti-cancer therapy within 2 weeks prior to the study treatment initiation. Note: systemic steroids are allowed if \\<= 100 mg/per day of prednisone (or equivalent) and were used for \\<= 7 days during 2 weeks before the study treatment initiation.\n5. Any investigational therapy within 2 weeks prior to the study treatment initiation.\n6. Known allergy or hypersensitivity to any of the study drugs.\n7. Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening.\n8. Active central nervous system involvement with lymphoma. Previously treated central nervous system involvement with lymphoma will be allowed if \\>3 months since end of treatment.\n9. Uncontrolled intercurrent illness, factors, evaluated by medical history, electrocardiogram (EKG), and physical exam that would potentially increase in risk of participant.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"National Cancer Institute Referral Offic","phone":"(888) 624-1937","email":"ncimo_referrals@mail.nih.gov"},{"name":"Samuel Y Ng, M.D.","phone":"(240) 858-7618","email":"samuel.ng@nih.gov"}],"primaryOutcomes":["Arm 2: To estimate the CRR of the combination of azacitidine and abatacept.","Arm 1: To estimate the MTD of the combination of azacitidine and abatacept in relapsed or refractory T-cell lymphoma."],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing azacitidine for Lymphoma, T Cell, Peripheral","inPlainEnglish":"Background: T-cell lymphoma is a blood cancer that affects immune system cells. People tend to survive less than 1 year if this disease does not respond to treatment (is refractory) or comes back after treatment (relapses).","whoItsFor":["Ages 18 Years to 120 Years","Participants must have a histologically or cytologically confirmed T-cell lymphoma confirmed by the Laboratory of Pathology (LP), NCI. The one of the following T-cell lymphomas are included:","Peripheral T-cell lymphoma not otherwise specified (PTCL, NOS)","Angioimmunoblastic T-cell lymphoma (AITL)","T-follicular helper (TFH) lymphoma","Anaplastic large cell lymphoma (ALCL)","Enteropathy-associated T-cell lymphoma (EATL)","Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL)"],"whoShouldSkip":["Any second malignancy that requires current active systemic therapy","Latent tuberculosis (TB) infection","Active systemic bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring anti-infective treatment within 1 day prior to the study treatment initiation","Anti-cancer therapy within 2 weeks prior to the study treatment initiation. Note: systemic steroids are allowed if \\<= 100 mg/per day of prednisone (or equivalent) and were used for \\<= 7 days during 2 weeks before the study treatment initiation","Any investigational therapy within 2 weeks prior to the study treatment initiation","Known allergy or hypersensitivity to any of the study drugs","Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test in WOCBP at screening"],"whatHappens":"If you join, the listed intervention(s) are azacitidine, or abatacept. The registry lists allocation as randomized. Background: T-cell lymphoma is a blood cancer that affects immune system cells.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.836Z"},{"nctId":"NCT07389590","title":"Study of Ublituximab for Ocrelizumab Wearing-Off in Multiple Sclerosis","officialTitle":"A Pilot Study of Ublituximab in People With MS Experiencing Wearing Off Phenomena While Receiving Treatment With Ocrelizumab","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a \"wearing off\" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.","conditions":["Multiple Sclerosis"],"keywords":["wearing off","ocrelizumab","ublituximab"],"interventions":[{"type":"DRUG","name":"Ublituximab"},{"type":"DRUG","name":"Ocrelizumab"}],"enrollment":50,"startDate":"2026-02-10","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with relapsing forms of MS.\n* Age between 18 and 65 years old (inclusive).\n* On treatment with standard interval ocrelizumab for at least one year.\n* Eligible and willing to continue treatment with ocrelizumab or ublituximab.\n* The presence of wearing off phenomena, defined as either worsening in any Neuro-QoL sleep disturbance, fatigue, depression, upper and lower extremity scores (moving from a lower category of symptom severity to a higher category, based on previously defined cutoff scores), a worsening of Neuro-QoL score of 10 points (which equals 1 SD) or more in any domain between a 1-2 month post-infusion assessment (after one ocrelizumab infusion) and a 1-2 month pre-infusion assessment (before the next scheduled infusion).\n\nExclusion Criteria:\n\n* Prior therapy: Has ever received any of the following:\n\n  * B-cell targeted therapies: rituximab, ofatumumab, ublituximab or other anti-CD20 agents besides ocrelizumab.\n  * Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide or HSCT.\n* Lymphopenia: a lymphocyte count \\<500/ millimeter (mm)\\^3. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.\n* Neutrophils \\<1.5X10E9/L. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible.\n* Clinically unstable medical or psychiatric disorder.\n* Substance abuse: has evidence of current drug or alcohol abuse or dependence.\n* 365 Day prior therapy: has received a biologic investigational agent other than B-cell targeted therapy \\[e.g., anti CD40L antibody\\].\n* Malignancy: has a history of malignancy in the past 5 years except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.\n* Have a history of a primary immunodeficiency.\n* Have a significant IgG deficiency (IgG level \\< 400 mg/dL).\n* Have an IgA deficiency (IgA level \\< 10 mg/dL).\n* Infection history:\n\n  * Currently on any suppressive therapy for chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria).\n  * Hospitalization for treatment of infection within 60 days of Screening.\n  * Use of parenteral (IV or IM) antibiotics (anti-bacterial, antiviral, anti-fungal, or anti-parasitic agents) within 60 days of Screening.\n* Other disease/conditions: has any of the following: a) clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.\n* Hepatitis status:\n\n  * Serologic evidence of current or past Hepatitis B (HB) infection based on the results of testing for HBsAg and HBcAb as follows: Patients positive for HBsAg or HBcAb are excluded.\n  * A positive test for Hepatitis C antibody\n* HIV: known to have a historically positive HIV test or tests positive at screening for HIV.\n* Laboratory abnormalities: An abnormal laboratory assessment is made, which is judged clinically significant by the investigator.\n* Drug Sensitivity: has a history of sensitivity to any of the study medications.\n* Any contraindication to undergoing MRI.\n* TB: tests positive at screening for tuberculosis.\n* Impaired decision-making capacity or impaired ability to provide informed consent.","locations":[{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ziyun Research Program Coordinator","phone":"410-614-1522","email":"zwang306@jhu.edu"}],"primaryOutcomes":["Proportion of Patients with Wearing-Off"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 4: testing Ublituximab for Multiple Sclerosis","inPlainEnglish":"The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a \"wearing off\" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.","whoItsFor":["Ages 18 Years to 65 Years","Patients with relapsing forms of MS","Age between 18 and 65 years old (inclusive)","On treatment with standard interval ocrelizumab for at least one year","Eligible and willing to continue treatment with ocrelizumab or ublituximab"],"whoShouldSkip":["Prior therapy: Has ever received any of the following:","B-cell targeted therapies: rituximab, ofatumumab, ublituximab or other anti-CD20 agents besides ocrelizumab","Prior use of cladribine, alemtuzumab, mitoxantrone, cyclophosphamide or HSCT","Lymphopenia: a lymphocyte count \\<500/ millimeter (mm)\\^3. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible","Neutrophils \\<1.5X10E9/L. Historical labs may be used if the collection date is 6 months or less prior to deeming eligible","Clinically unstable medical or psychiatric disorder","Substance abuse: has evidence of current drug or alcohol abuse or dependence"],"whatHappens":"If you join, the listed intervention(s) are Ublituximab, or Ocrelizumab. The registry lists allocation as randomized. The proposed study is a pilot study of ublituximab involving people with multiple sclerosis (MS) who are experiencing a \"wearing off\" phenomenon (return or worsening of MS-related symptoms) while being treated with ocrelizumab, and exploring whether switching to ublituzimab can resolve, improve or delay this phenomenon.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 50 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.994Z"},{"nctId":"NCT07390344","title":"VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)","officialTitle":"VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"W.L.Gore & Associates","sponsorClass":"INDUSTRY","summary":"This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.\n\nAdditionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.","conditions":["Ascites","Variceal Bleeding","Portal Hypertension Related to Cirrhosis"],"keywords":["portal hypertension","TIPS","cirrhosis","decompensated","Transjugular Intrahepatic Portosystemic Shunt"],"interventions":[{"type":"DEVICE","name":"GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)"}],"enrollment":152,"startDate":"2026-07-20","completionDate":"2029-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.\n2. The subject has cirrhotic portal hypertension.\n3. The subject is ≥18 years of age.\n4. The subject is capable of complying with protocol requirements, including follow up.\n5. The subject or legal representative signed the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.\n2. The subject has received a liver transplantation. Patients on the transplant list are still eligible.\n3. The subject has a life expectancy of less than 6 months.\n4. The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible.\n5. The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \\> 25 or Child Pugh Score of \\> 14.\n6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.\n7. The subject is pregnant at the time of informed consent signature.\n8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.","locations":[{"facility":"Emory University Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Careggi","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"The VIATIPS clinical study team","phone":"800-437-8181","email":"viatips@wlgore.com"}],"primaryOutcomes":["Proportion of Subjects achieving primary patency through 2 years"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","minneapolis-minnesota","cleveland-ohio","dallas-texas","florence-italy"],"enrichment":{"headline":"Not a traditional drug phase: GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for Ascites","inPlainEnglish":"This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.","whoItsFor":["Ages 18 Years to any","The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation","The subject has cirrhotic portal hypertension","The subject is ≥18 years of age","The subject is capable of complying with protocol requirements, including follow up"],"whoShouldSkip":["The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis","The subject has received a liver transplantation. Patients on the transplant list are still eligible","The subject has a life expectancy of less than 6 months","The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and/or carcinoma in situ of the cervix remain eligible","The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \\> 25 or Child Pugh Score of \\> 14","The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor","The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 152 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.036Z"},{"nctId":"NCT07390916","title":"Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda","officialTitle":"Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fred Hutchinson Cancer Center","sponsorClass":"OTHER","summary":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. This is even more important at a time when Rwanda has launched a National Cervical Cancer Screening Program (NCCSP) with human papillomavirus (HPV) testing and treatment, mainly using TA with unknown outcomes. Therefore, we will conduct a feasibility study (C1001P-CS5) among 300 Rwandan WLWH to provide evidence needed to launch a future effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030. Rwanda hopes to achieve this goal early, in 2027 under Mission 2027.","conditions":["HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer"],"keywords":["HIV","Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus"],"interventions":[{"type":"PROCEDURE","name":"Thermal ablation (TA) with 1 probe"},{"type":"PROCEDURE","name":"Thermal ablation (TA) with 2 probes"}],"enrollment":300,"startDate":"2026-10-15","completionDate":"2027-12-31","sex":"FEMALE","minAge":"25 Years","maxAge":"49 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","locations":[{"facility":"Research for Development (RD) Rwanda","city":"Kigali","state":"","country":"Rwanda","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Araceli Loera, MPH","phone":"+1 206-667-5816","email":"aloera@fredhutch.org"}],"primaryOutcomes":["Proportion of participants with persistent HPV at 6 months"],"hasResults":false,"conditionSlugs":["cervical-cancer","als","hiv"],"drugSlugs":[],"locationSlugs":["kigali-rwanda"],"enrichment":{"headline":"Not a traditional drug phase: Thermal ablation (TA) with 1 probe for HIV (Human Immunodeficiency Virus)","inPlainEnglish":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its how well it works can be suboptimal in WLWH.","whoItsFor":["Ages 25 Years to 49 Years","Women only","who can join specific to the feasibility study","Willing to return to facility at 6 months","Positive hrHPV or VIA test within 3 months of enrollment","Type 1 transformation zone (TZ1)","Thermal ablation eligible"],"whoShouldSkip":["Screened for cervical cancer outside of study in last 6 months","Currently pregnant or less than 6 weeks postpartum","Prior diagnosis of cervical cancer","A history of treatment for cervical precancer","Currently receiving treatment for any cancer","Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study","Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled"],"whatHappens":"If you join, the listed intervention(s) are Thermal ablation (TA) with 1 probe, or Thermal ablation (TA) with 2 probes. The registry lists allocation as randomized. Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Kigali. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.542Z"},{"nctId":"NCT07391267","title":"Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide.","officialTitle":"Pathogenesis of Chronic Kidney Disease Associated With Metabolic Dysfunction- Associated Fatty Liver Disease (MAFLD) and Treatment Response of Oral Semaglutide - a Randomized Controlled Trial.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Institute of Liver and Biliary Sciences, India","sponsorClass":"OTHER","summary":"This project aims to investigate how Chronic Kidney Disease (CKD) develops and progresses in patients who also have Non-Alcoholic Fatty Liver Disease (NAFLD) and to evaluate whether oral semaglutide (a GLP-1 receptor agonist) can slow or prevent this progression.\n\nNAFLD and CKD frequently coexist due to shared mechanisms such as insulin resistance, inflammation, oxidative stress, dyslipidemia, and metabolic syndrome. Because of these overlapping pathways, a single therapy targeting both organs may offer major benefits.\n\nSemaglutide is known to reduce liver fat, improve inflammation and fibrosis, promote weight loss, and provide renal protection. This project will test whether adding oral semaglutide to standard care leads to better kidney and liver outcomes than standard care alone.\n\nThe study is designed as a randomised controlled trial conducted at ILBS, enrolling adults having NAFLD with CKD (with specific eGFR and albuminuria criteria). Participants will be followed for 2 years, with regular assessment of kidney function (eGFR, ACR), liver health (FibroScan, ALT/AST), metabolic parameters, and cardiovascular outcomes.\n\nA parallel animal study in mice with diet-induced fatty liver disease will validate mechanistic findings through liver and kidney histology, gene expression, metabolic tests, and biochemical markers after semaglutide treatment.\n\nExpected outcome: To demonstrate that semaglutide slows CKD progression and improves NAFLD, supporting its use as a therapeutic option for patients with coexisting both conditions.","conditions":["Chronic Kidney Diseases","MAFLD"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide Oral Tablet"},{"type":"OTHER","name":"Placebo"},{"type":"OTHER","name":"Standard medical treatment"}],"enrollment":90,"startDate":"2026-05-25","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1.Age above or equal to 18 years at the time of signing informed consent. 2.Diagnosed with type 2 diabetes mellitus 3.HbA1c less than or equal to 10% (less than or equal to 86 mmol/mol) 4.Renal impairment defined either by:\n* serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or\n* serum creatinine-based eGFR greater than or equal to 25 and less than 50 mL/min/1.73 m\\^2 (CKD-EPI) and UACR greater than 100 and less than 5000 mg/g 5.Treatment with maximum labelled or tolerated dose of a reninangiotensin-aldosterone system (RAAS) blocking agent including an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of the inclusion criteria for renal impairment and kept stable until screening.\n\nExclusion Criteria:\n\n1. Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)\n2. Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).\n3. Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.\n4. Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).\n5. Treatment with vitamin E (at doses greater than or equal to 800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.\n6. Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).\n7. Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.\n8. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations\n9. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.\n10. Presently classified as being in New York Heart Association (NYHA) Class IV heart failure\n11. Planned coronary, carotid or peripheral artery revascularisation\n12. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis 13 Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupildilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n\n    \\-","locations":[{"facility":"Institute of Liver and Biliary Sciences","city":"New Delhi","state":"National Capital Territory of Delhi","country":"India","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr Chandani Bhagat, DM","phone":"01146300000","email":"chandani.bhagat@gmail.com"}],"primaryOutcomes":["Time to first occurrence of a composite primary outcome event defined as persistent eGFR decline of greater than or equal to 50 percentage from trial start, reaching ESRD, death from kidney disease or death from cardiovascular disease."],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":["semaglutide"],"locationSlugs":["new-delhi-india"],"enrichment":{"headline":"Not a traditional drug phase: testing Semaglutide Oral Tablet for Chronic Kidney Diseases","inPlainEnglish":"This project aims to investigate how Chronic Kidney Disease (CKD) develops and progresses in patients who also have Non-Alcoholic Fatty Liver Disease (NAFLD) and to evaluate whether oral semaglutide (a GLP-1 receptor agonist) can slow or prevent this progression. NAFLD and CKD frequently coexist due to shared mechanisms such as insulin resistance, inflammation, oxidative stress, dyslipidemia, and metabolic syndrome.","whoItsFor":["Ages 18 Years to any","serum creatinine-based eGFR greater than or equal to 50 and less than or equal to 75 mL/min/1.73 m\\^2 (CKD-EPI) and UACR greater than 300 and less than 5000 mg/g or"],"whoShouldSkip":["Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)","Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A)","Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation","Known or suspected excessive consumption of alcohol (greater than 20 g/day for women or greater than 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire))","Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A)","Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations","Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide Oral Tablet, Placebo, or Standard medical treatment. The registry lists allocation as randomized. This project aims to investigate how Chronic Kidney Disease (CKD) develops and progresses in patients who also have Non-Alcoholic Fatty Liver Disease (NAFLD) and to evaluate whether oral semaglutide (a GLP-1 receptor agonist) can slow or prevent this progression.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at New Delhi. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.143Z"},{"nctId":"NCT07391332","title":"Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study","officialTitle":"Psilocybin AsSisted pSychotherapy for the treatmENt of Gambling disordER : a Pilot Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Nantes University Hospital","sponsorClass":"OTHER","summary":"The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomized clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol. Other objectives of the study will be to generate preliminary efficacy data, identify clinical factors potentially associated with the intensity of the psychedelic experience (which determines the expected therapeutic effect), and conduct a preliminary assessment of the safety of the treatment under study.","conditions":["Gambling Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate)"},{"type":"DRUG","name":"Psychotherapy assisted by low-dose psilocybin (1 mg)"}],"enrollment":30,"startDate":"2026-10-08","completionDate":"2029-07-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Men and women aged 18 years or older\n* With a confirmed diagnosis of current gambling disorder (diagnostic criteria according to DSM-5), regardless of severity.\n* Able to complete self-assessment questionnaires\n* Willing to start addiction treatment, or for whom treatment already undertaken is not sufficient\n* Willing to undergo a blood test and ECG\n* Written and oral comprehension of French\n* Having signed an informed consent form before any procedure under study\n* Affiliated with a French social security system\n* Women of childbearing age with a negative pregnancy test and highly effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations in Appendix 7)\n* Men of childbearing age using effective contraception (according to version 1.2 of March 2024 of the CTCG recommendations).\n* Negative result on urinary toxicology screening\n* In the case of psychotropic treatment (excluding nicotine replacement therapy): stabilization of dosage or initiation for more than 1 month.\n\nExclusion Criteria:\n\n* Medical conditions that would prevent safe participation in the trial (epilepsy, significantly impaired liver function (TP\\<50%), significantly impaired kidney function (GFR\\<90 mL/min), coronary artery disease, history of arrhythmia, heart failure, uncontrolled hypertension, history of stroke, severe asthma, hyperthyroidism, narrow-angle glaucoma, symptomatic prostatic hypertrophy, or bladder neck obstruction).\n* Serious ECG abnormalities (including QTc prolongation = corrected QT)\n* Current or past psychotic or bipolar disorder\n* Other unstable psychiatric disorder\n* Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder\n* Current high risk of suicide (according to the MINI 5.0 suicide risk module)\n* History of hallucinogen use disorder or any use in the past year\n* Current alcohol use disorder with a history of withdrawal symptoms\n* Extreme thinness (BMI \\< 16.5) or obesity (BMI \\> 30)\n* Major cognitive impairment (Mini-Mental State Examination score \\< 26)\n* Allergy or hypersensitivity to psilocybin or any of the excipients contained in the investigational drug\n* Taking UGT1A9, UGT1A10, ALDH, or ADH inhibitors\n* Pregnancy or breastfeeding\n* Current protective measures (guardianship and legal protection)\n* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical progression","locations":[{"facility":"Nantes University Hospital","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Benoit SCHRECK","phone":"+33.2.40.84.76.20","email":"benoit.schreck@chu-nantes.fr"}],"primaryOutcomes":["Protocol completion rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["nantes-france"],"enrichment":{"headline":"Phase 2: testing Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate) for Gambling Disorder","inPlainEnglish":"The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomly assigned clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder. Feasibility will be assessed by estimating the ability to retain participants until the end of the protocol.","whoItsFor":["Ages 18 Years to any","Men and women aged 18 years or older","With a confirmed diagnosis of current gambling disorder (diagnostic criteria according to DSM-5), regardless of severity","Able to complete self-assessment questionnaires","Willing to start addiction treatment, or for whom treatment already undertaken is not sufficient","Willing to undergo a blood test and ECG","Written and oral comprehension of French","Affiliated with a French social security system"],"whoShouldSkip":["Serious ECG abnormalities (including QTc prolongation = corrected QT)","Current or past psychotic or bipolar disorder","Other unstable psychiatric disorder","Family history (first-degree relatives) of psychotic disorder or type 1 bipolar disorder","Current high risk of suicide (according to the MINI 5.0 suicide risk module)","History of hallucinogen use disorder or any use in the past year","Current alcohol use disorder with a history of withdrawal symptoms"],"whatHappens":"If you join, the listed intervention(s) are Psychotherapy assisted by high-dose psilocybin (25mg or 40mg where appropriate), or Psychotherapy assisted by low-dose psilocybin (1 mg). The registry lists allocation as randomized. The PASSENGER project aims to conduct a pilot feasibility study of the implementation of a randomly assigned clinical trial on psilocybin-assisted psychotherapy for the treatment of gambling disorder.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Nantes. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.099Z"},{"nctId":"NCT07391982","title":"Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions","officialTitle":"Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The Netherlands Cancer Institute","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.\n\nThe main questions it aims to answer are:\n\n* Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?\n* Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas?\n\nResearchers will compare two treatment approaches:\n\n* One group receives a uniform high dose to the entire prostate.\n* The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas.\n\nParticipants will:\n\n* Receive two sessions of MRI-guided radiotherapy using an MR-Linac.\n* Complete questionnaires about urinary, bowel, and sexual health before and after treatment.\n* Have follow-up visits to monitor side effects and PSA levels for up to 2 years.","conditions":["Prostate Cancer (Adenocarcinoma)"],"keywords":["De-escalation","Radiotherapy","MR-Linac"],"interventions":[{"type":"RADIATION","name":"uniform dose radiotherapy"},{"type":"RADIATION","name":"De-escalated dose radiotherapy"}],"enrollment":54,"startDate":"2025-11-17","completionDate":"2027-02","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Men aged ≥18 years\n2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy\n3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)\n4. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and \\<2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry\n5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported).\n6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)\n7. PSA \\<20 ng/ml prior to starting androgen deprivation therapy (ADT).\n8. WHO Performance status 0-2\n9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form.\n10. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.\n\nExclusion Criteria:\n\n1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)\n2. IPSS Score \\> 19\n3. High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.\n4. Prostate volume \\>90cc\n5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up\n6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging\n7. Previous pelvic radiotherapy\n8. Patients needing \\>6 months of ADT due to disease parameters.\n9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.","locations":[{"facility":"The Netherlands Cancer Institute","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Floris Pos, MD, PhD","phone":"+31205129111","email":"f.pos@nki.nl"}],"primaryOutcomes":["Acute GU toxicity"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["amsterdam-netherlands"],"enrichment":{"headline":"Not a traditional drug phase: uniform dose radiotherapy for Prostate Cancer (Adenocarcinoma)","inPlainEnglish":"The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer. The main questions it aims to answer are: * Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects?","whoItsFor":["Ages 18 Years to any","Men only","Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy","Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)","The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported)","MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018)","PSA \\<20 ng/ml prior to starting androgen deprivation therapy (ADT)","WHO Performance status 0-2","Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study"],"whoShouldSkip":["Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)","High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area","Prostate volume \\>90cc","Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up","Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging","Previous pelvic radiotherapy","Patients needing \\>6 months of ADT due to disease parameters"],"whatHappens":"If you join, the listed intervention(s) are uniform dose radiotherapy, or De-escalated dose radiotherapy. The registry lists allocation as randomized. The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 54 people at Amsterdam. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.316Z"},{"nctId":"NCT07392476","title":"Continuous Glucose Monitoring in Polycystic Ovarian Syndrome","officialTitle":"Continuous Glucose Monitoring in Polycystic Ovarian Syndrome","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"The Cleveland Clinic","sponsorClass":"OTHER","summary":"The purpose of this study is to learn more about blood sugar control in polycystic ovarian syndrome.\n\nThe patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels. The patient will wear this at certain time points throughout the study. There will have a total of 2 blood draws (about 1 tsp. of blood) at screening and the 6-month visit, a measure of the patients body muscle and fat (body composition), and fill out a questionnaire at the end of the first 3 months and 6 months.\n\nStudy participation in the research will last about 6 months.","conditions":["Polycystic Ovarian Syndrome (PCOS)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Stelo glucose biosensor by Dexcom"}],"enrollment":40,"startDate":"2025-12-24","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Adult 18-45 years old\n2. Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria\n3. BMI \\>25 kg/m2\n\nExclusion Criteria\n\n1. Currently on medications that can improve glucose levels such as metformin and glucagon like receptor 1 agonists (GLP1RA) or on medications taken for the purpose of weight loss such as phentermine, topiramate, and bupropion.\n2. Previously intake of above-mentioned medications and less than 3 months since last intake of metformin or weight loss medications, and less than 6 months since last intake of GLP1RA\n3. Currently on insulin\n4. Does not have Stelo-compatible phone\n5. Fasting glucose \\>100 mg/dL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study\n6. HbA1c \\> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)\n7. History of anorexia or bulimia\n8. Current or previous CGM use\n9. Use of oral contraceptives at time of enrolment\n10. Intent to become pregnant within 6 months (will need to terminate study if gets pregnant as glucose readings will be affected)\n11. Menopausal women","locations":[{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrea Parianos, MS","phone":"216-445-8354","email":"debsa@ccf.org"}],"primaryOutcomes":["Continuous Glucose measure derived glucometrics","Continuous Glucose measure derived glucometrics and Polycystic ovarian syndrome","Lifestyle behaviors"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Stelo glucose biosensor by Dexcom for Polycystic Ovarian Syndrome (PCOS)","inPlainEnglish":"This study wants to learn more about blood sugar control in polycystic ovarian syndrome. The patient will be asked to wear a continuous glucose monitor (CGM) device that is applied to the arm with a sensor or filament that goes under the skin to measure your sugar levels.","whoItsFor":["Ages 18 Years to 45 Years","Adult 18-45 years old","Diagnosis of PCOS by usual clinical method such as by Rotterdam criteria"],"whoShouldSkip":["Currently on medications that can improve glucose levels such as metformin and glucagon like receptor 1 agonists (GLP1RA) or on medications taken for the purpose of weight loss such as phentermine, topiramate, and bupropion","Previously intake of above-mentioned medications and less than 3 months since last intake of metformin or weight loss medications, and less than 6 months since last intake of GLP1RA","Currently on insulin","Does not have Stelo-compatible phone","Fasting glucose \\>100 mg/dL (because that is the cutoff for prediabetes) (either labs taken within a week after first visit or within 3 months before start of study","HbA1c \\> 5.7% (because this is the cutoff for prediabetes) (either labs taken after screening visit or within 3 months before start of study)","History of anorexia or bulimia"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Cleveland. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.789Z"},{"nctId":"NCT07392645","title":"Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms","officialTitle":"Clinical Efficacy of Electroacupuncture for Generalized Anxiety Disorder and Its Central Mechanism Based on Neuroimaging Changes","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Lishu Gao","sponsorClass":"OTHER","summary":"This study aims to evaluate the clinical efficacy and safety of electroacupuncture (EA) as an adjunctive treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group. All participants in the clinical trial will receive monotherapy with one of three SSRIs: sertraline, paroxetine, or escitalopram, selected by a psychiatrist according to clinical suitability, previous treatment response, and tolerability. Clinical efficacy will be assessed using the Hamilton Anxiety Rating Scale (HAMA). The neuroimaging substudy will include healthy controls and two groups of patients with GAD receiving SSRI monotherapy with an unchanged medication type and daily dose for at least 2 weeks: an EA group and a sham EA group. Healthy controls will undergo a single resting-state functional MRI (rs-fMRI) scan, whereas patients will undergo scans before and after a single 30-minute EA or sham EA session on the same day. Functional connectivity (FC), regional homogeneity (ReHo), and amplitude of low-frequency fluctuation (ALFF) will be compared between healthy controls and patients before intervention, and pre-to-post changes will be compared between the EA and sham EA groups.","conditions":["Generalized Anxiety Disorder"],"keywords":["Electroacupuncture","Generalized Anxiety Disorder","fMRI","Clinical Efficacy"],"interventions":[{"type":"PROCEDURE","name":"Electroacupuncture (EA)"},{"type":"PROCEDURE","name":"Sham Electroacupuncture (SEA)"},{"type":"DRUG","name":"Medication"}],"enrollment":123,"startDate":"2026-03-10","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD).\n* the patient has been taking the same anxiolytic medication consistently for 2 weeks prior to enrollment.\n* HAMA score ≥ 14.\n* Right-handed（for MRI).\n* Aged 18-60 years, with at least primary school education.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Complicated with severe cardiovascular, cerebrovascular, or organic diseases.\n* History of other psychiatric disorders (e.g., schizophrenia, bipolar disorder).\n* Contraindications for MRI (e.g., metal implants, claustrophobia).\n* Pregnancy or lactation.","locations":[{"facility":"Affiliated Hangzhou First People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lishu Gao","phone":"+86 13858015836","email":"rodelo@sina.com"}],"primaryOutcomes":["Effective rate of HAMA score reduction at Week 4"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Medication for Generalized Anxiety Disorder","inPlainEnglish":"This study aims to measure the clinical how well it works and safety of electroacupuncture (EA) as an added on top of your current treatment treatment for generalized anxiety disorder (GAD). Participants in the clinical trial will be randomly assigned to an EA group, a sham EA group, or a waiting-list control group.","whoItsFor":["Ages 18 Years to 60 Years","Meet the DSM-5 diagnostic criteria for Generalized Anxiety Disorder (GAD)","the patient has been taking the same anxiolytic medication consistently for 2 weeks prior to enrollment","Right-handed（for MRI)","Aged 18-60 years, with at least primary school education"],"whoShouldSkip":["Complicated with severe cardiovascular, cerebrovascular, or organic diseases","History of other psychiatric disorders (e.g., schizophrenia, bipolar disorder)","Contraindications for MRI (e.g., metal implants, claustrophobia)","Pregnancy or lactation"],"whatHappens":"If you join, the listed intervention(s) are Electroacupuncture (EA), Sham Electroacupuncture (SEA), or Medication. The registry lists allocation as randomized. This study aims to measure the clinical how well it works and safety of electroacupuncture (EA) as an added on top of your current treatment treatment for generalized anxiety disorder (GAD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 123 people at Hangzhou. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.349Z"},{"nctId":"NCT07393282","title":"A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)","officialTitle":"A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants With Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called linvoseltamab (also called \"study drug\") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.\n\nThe aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)","conditions":["High Risk Smoldering Multiple Myeloma (HR-SMM)"],"keywords":["Linvoseltamab","Multiple Myeloma (MM)","B Cell Maturation Antigen (BCMA)","Bispecific antibody","Smoldering Multiple Myeloma (SMM)","Smoldering Myeloma","HR-SMM","Linozyfic","Darzalex"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"},{"type":"DRUG","name":"Daratumumab"}],"enrollment":270,"startDate":"2026-05-21","completionDate":"2033-07-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status score ≤1\n2. SMM diagnosis per IMWG criteria as defined in the protocol\n3. Meets HR-SMM criteria by 1 of the risk models as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol\n2. Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma\n3. History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder\n4. History of a seizure within the 12 months of randomization\n5. Prior exposure to any approved or investigational treatments directed against a clonal plasma cell disorder (including but not limited to conventional chemotherapies, radiotherapy, immunomodulatory drugs, proteasome inhibitors, anti-CD38 antibodies). Ongoing treatment with other monoclonal antibodies (eg, infliximab, rituximab) or other treatments likely to interfere with study procedures or results, as described in the protocol.\n\nNOTE: Other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"Mayo Clinic Phoenix, Mayo Clinic Building","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University - Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber / Harvard Cancer Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Ann Karmanos Cancer Institute - Detroit","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de Cannes","city":"Cannes","state":"Cannes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Service d'Hematologie","city":"Pessac","state":"Gironde","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Saint Vincent de Paul","city":"Lille","state":"Nord","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (CHU) de Toulouse","city":"Toulouse","state":"Occitanie","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya City University Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Okayama Medical Center","city":"Okayama","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokushima Prefectural Central Hospital","city":"Tokushima","state":"Tokushima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yamanashi Prefectural Central Hospital","city":"Kofu","state":"Yamanashi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Matsumoto Medical Center","city":"Matsumoto-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aidport Sp. z o.o.","city":"Skorzewo","state":"Wielkopolska","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia Onkologia Katowice","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, St Vincents Hospital","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chonnam National University Hwasun Hospital","city":"Hwasun","state":"Jeollanam-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul St. Mary's Hospital, The Catholic University of Korea","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Cornwall Hospital","city":"Truro","state":"Cornwall","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norfolk and Norwich University Hospital","city":"Norwich","state":"Norfolk","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden NHS Foundation Trust","city":"Sutton","state":"Surrey","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Leicester","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Bartholomew's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hammersmith Hospital, Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Clinical Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) criteria","Biochemical PFS per IMWG criteria"],"hasResults":false,"conditionSlugs":["multiple-myeloma","als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","atlanta-georgia","boston-massachusetts","detroit-michigan","rochester-minnesota","st-louis-missouri","new-york-new-york","columbus-ohio","cannes-france","pessac-france","lille-france","toulouse-france","nagoya-japan","okayama-japan","tokushima-japan","kofu-japan","matsumoto-shi-japan","skorzewo-poland","katowice-poland","suwon-south-korea","hwasun-south-korea","seoul-south-korea","truro-united-kingdom","norwich-united-kingdom","sutton-united-kingdom","leicester-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Linvoseltamab for High Risk Smoldering Multiple Myeloma (HR-SMM)","inPlainEnglish":"This study is researching an experimental drug called linvoseltamab (also called \"study drug\") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma. The aim of this study is to find out whether linvoseltamab is better than daratumumab in delaying the development of MM.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group performance status score ≤1","SMM diagnosis per IMWG criteria as defined in the protocol","Meets HR-SMM criteria by 1 of the risk models as defined in the protocol"],"whoShouldSkip":["Evidence of myeloma-defining events attributable to the underlying plasma cell dyscrasia, as defined in the protocol","Diagnosis of systemic light chain amyloidosis, Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), plasma cell leukemia, or soft tissue plasmacytoma","History of neurodegenerative condition, progressive multifocal leukoencephalopathy, or Central Nervous System (CNS) movement disorder","History of a seizure within the 12 months of randomization","NOTE: Other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Linvoseltamab, or Daratumumab. The registry lists allocation as randomized. This study is researching an experimental drug called linvoseltamab (also called \"study drug\") compared to another drug called daratumumab, in participants with Smoldering Multiple Myeloma (SMM), who are at a High Risk (HR) of developing active multiple myeloma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 270 people at 33 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.502Z"},{"nctId":"NCT07393958","title":"Impact of Food Supplementation on Quality of Life in Patients With Endometriosis and Pelvic Pain.","officialTitle":"Experimental Study of Quality of Life in Patients With Endometriosis and Pelvic Pain Treated With Doliral Dietary Supplementation Versus Placebo.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Arafarma Group, S.A.","sponsorClass":"INDUSTRY","summary":"This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with placebo, over several weeks.","conditions":["Endometriosis (Diagnosis)"],"keywords":["pain","QoL","food supplement"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Food supplement (T1675)"},{"type":"OTHER","name":"Placebo"}],"enrollment":60,"startDate":"2026-02-26","completionDate":"2027-08-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification.\n* Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound.\n* Presence of pelvic pain (VAS \\> 4) during the last three months.\n* No indication for surgical intervention at the time of inclusion in the study.\n* Patients who are able to provide informed consent.\n\nExclusion Criteria:\n\n* Patients under 18 years of age.\n* Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day.\n* Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study.\n* Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study.\n* Patients with known allergy or hypersensitivity to Doliral®.\n* Pregnant or breastfeeding patients.\n* Patients on sick leave: \\> 1 year, or With no intention of returning to work, or Undergoing a disability or permanent incapacity assessment process.","locations":[{"facility":"Hospital Clínic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tamara Rodríguez Araya, Dr","phone":"+34 932 27 54 00","email":"tlrodriguez@clinic.cat"}],"primaryOutcomes":["To measure the improvement of the quality of life.","To measure the improvement of the quality of life.","To measure the improvement of the quality of life.","To measure the improvement in pain intensity."],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["barcelona-spain"],"enrichment":{"headline":"Not a traditional drug phase: Food supplement (T1675) for Endometriosis (Diagnosis)","inPlainEnglish":"This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with dummy treatment (placebo), over several weeks.","whoItsFor":["Ages 18 Years to any","Women only","Women of reproductive age with diagnosed endometriosis stage I, II, or III, according to the American Society for Reproductive Medicine (ASRM) classification","Women with a diagnosis of endometriosis confirmed by laparoscopy or, in the absence of laparoscopy, by magnetic resonance imaging (MRI) and/or ultrasound","Presence of pelvic pain (VAS \\> 4) during the last three months","No indication for surgical intervention at the time of inclusion in the study"],"whoShouldSkip":["Patients under 18 years of age","Use of analgesic or anti-inflammatory pharmacological treatment, except for ibuprofen at doses up to 600 mg/day or naproxen at doses up to 500 mg/day","Surgery within the year prior to inclusion, performed for therapeutic purposes related to the pathology under study","Initiation or discontinuation of hormone therapy within the three months prior to inclusion in the study","Patients with known allergy or hypersensitivity to Doliral®","Pregnant or breastfeeding patients","Patients on sick leave: \\> 1 year, or With no intention of returning to work, or Undergoing a disability or permanent incapacity assessment process"],"whatHappens":"If you join, the listed intervention(s) are Food supplement (T1675), or Placebo. The registry lists allocation as randomized. This study examines whether the food supplement Doliral can improve quality of life and reduce pelvic pain in women with endometriosis, compared with dummy treatment (placebo), over several weeks.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Barcelona. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.109Z"},{"nctId":"NCT07394530","title":"Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS","officialTitle":"A Comparative Study of In Vitro Fertilization Outcomes Between PPOS and Antagonist Protocols in Women With Polycystic Ovary Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Hanoi General Hospital (Vietnam)","sponsorClass":"OTHER","summary":"This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.","conditions":["Polycystic Ovary Syndrome (PCOS)","Female Infertility"],"keywords":[],"interventions":[{"type":"DRUG","name":"Progestin-Primed Ovarian Stimulation (PPOS)"},{"type":"DRUG","name":"GnRH Antagonist Protocol"}],"enrollment":400,"startDate":"2026-01-20","completionDate":"2027-06-30","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged 18-40 years\n* Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)\n* Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)\n* Eligible for controlled ovarian stimulation for IVF\n* Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.\n* History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)\n* History of recurrent pregnancy loss (≥3 spontaneous miscarriages)\n* Known chromosomal abnormalities in either partner\n* Inability to adhere to study protocol or follow-up procedures","locations":[{"facility":"Hanoi General Hospital","city":"Hanoi","state":"Hanoi","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Phuong Duy Nguyen, MD, MSc - PI","phone":"+84 986656835","email":"nguyenduyphuongncs44@gmail.com"},{"name":"Anh Huynh Phuong Nguyen, MD, MSc, Study Coordinator","phone":"","email":"pn991897@gmail.com"}],"primaryOutcomes":["Ongoing pregnancy rate at 12 weeks"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["hanoi-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: testing Progestin-Primed Ovarian Stimulation (PPOS) for Polycystic Ovary Syndrome (PCOS)","inPlainEnglish":"This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Women aged 18-40 years","Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)","Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)","Eligible for controlled ovarian stimulation for IVF","Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)"],"whoShouldSkip":["Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology","History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)","History of recurrent pregnancy loss (≥3 spontaneous miscarriages)","Known chromosomal abnormalities in either partner","Inability to adhere to study protocol or follow-up procedures"],"whatHappens":"If you join, the listed intervention(s) are Progestin-Primed Ovarian Stimulation (PPOS), or GnRH Antagonist Protocol. The registry lists allocation as randomized. This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 400 people at Hanoi. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.794Z"},{"nctId":"NCT07394712","title":"Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.","officialTitle":"Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Institut de Recerca Biomèdica de Lleida","sponsorClass":"OTHER","summary":"Introduction:\n\nPulmonary rehabilitation programs (PRPs) are known to reduce symptoms such as dyspnea and fatigue, while improving functional capacity and quality of life in individuals with chronic obstructive pulmonary disease (COPD). However, the benefits of an initial pulmonary rehabilitation program (PRP) tend to diminish rapidly over time, prompting the development of strategies to maintain these effects. Such strategies include supervised exercise programs, telephone follow-ups, and home-based exercise regimens. Nevertheless, the optimal maintenance strategy remains uncertain.\n\nObjectives:\n\nThe primary objective is to evaluate the impact of a supervised, multidimensional maintenance PRP on symptoms and quality of life in individuals with COPD. Additionally, the study aims to compare exercise capacity, healthcare resource utilization, economic benefits, and participant perceptions between the intervention and control groups.\n\nMethodology:\n\nA 12-month randomized controlled trial (RCT) with two parallel groups will be conducted in adults with COPD who have completed an initial 8-week PRP. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. The intervention group will undergo a maintenance PRP consisting of two weekly supervised exercise sessions and monthly educational sessions on COPD in a comprehensive health center over a 3-month period. The control group will receive standard clinical care recommendations regarding physical activity. Clinical evaluations will be conducted at four time points throughout the study: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3). Full pulmonary function tests and anthropometric assessments will be performed at T0 and T3. Other variables, including symptom burden, quality of life, functional capacity, mental health, physical activity, sleep-wake pattern, and healthcare utilization, will be systematically collected at all four time points.","conditions":["COPD - Chronic Obstructive Pulmonary Disease","Pulmonary Rehabilitation","Randomised Controlled Trial"],"keywords":["Pulmonary rehabilitation","chronic obstructive pulmonary disease (COPD)","Randomised controlled trial"],"interventions":[{"type":"BEHAVIORAL","name":"Interdisciplinary intervention"}],"enrollment":86,"startDate":"2025-10-01","completionDate":"2027-10","sex":"ALL","minAge":"40 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 40 to 75 years.\n* Confirmed medical diagnosis of chronic obstructive pulmonary disease (COPD) of moderate to severe severity, based on clinical evaluation and pulmonary function testing.\n* Clinically stable for at least 4 weeks following the last severe exacerbation, as confirmed by the treating pulmonologist.\n* Referred to an outpatient pulmonary rehabilitation program due to persistent symptoms and a history of exacerbations, with moderate to severe dyspnea (Medical Research Council \\[MRC\\] dyspnea scale score \\> 2), according to physician assessment.\n* Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program.\n\nExclusion Criteria:\n\n* Presence of medical contraindications to physical exercise, including unstable cardiovascular conditions (e.g., recent myocardial infarction, uncontrolled arrhythmias), severe musculoskeletal or neurological disorders, recent surgery, or acute medical conditions (e.g., recent stroke) that impair participation.\n* Severe cognitive impairment that limits the ability to understand instructions or participate actively in the program.\n* Unstable psychiatric disorders that may compromise adherence to or continuity with the exercise regimen.\n* Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program.\n* Participation in another pulmonary rehabilitation program within the 6 months prior to study enrollment.","locations":[{"facility":"Arnau de Vilanova University Hospital","city":"Lleida","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arnau de Vilanova University Hospital","city":"Lleida","state":"Lleida","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica G MD, PhD, MD, PhD","phone":"973702497","email":"jgonzalezgutierrez88@gmail.com"},{"name":"Ferran Barbé, MD, PhD","phone":"973702959","email":"febarbe.lleida.ics@gencat.cat"}],"primaryOutcomes":["Dyspnea (Dyspnea-12 total score)"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["lleida-spain"],"enrichment":{"headline":"Not a traditional drug phase: Interdisciplinary intervention for COPD - Chronic Obstructive Pulmonary Disease","inPlainEnglish":"Introduction: Pulmonary rehabilitation programs (PRPs) are known to reduce symptoms such as dyspnea and fatigue, while improving functional capacity and quality of life in individuals with chronic obstructive pulmonary disease (COPD). However, the benefits of an initial pulmonary rehabilitation program (PRP) tend to diminish rapidly over time, prompting the development of strategies to maintain these effects.","whoItsFor":["Ages 40 Years to 75 Years","Adults aged 40 to 75 years","Confirmed medical diagnosis of chronic obstructive pulmonary disease (COPD) of moderate to severe severity, based on clinical evaluation and pulmonary function testing","Clinically stable for at least 4 weeks following the last severe exacerbation, as confirmed by the treating pulmonologist","Referred to an outpatient pulmonary rehabilitation program due to persistent symptoms and a history of exacerbations, with moderate to severe dyspnea (Medical Research Council \\[MRC\\] dyspnea scale score \\> 2), according to physician assessment","Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program"],"whoShouldSkip":["Severe cognitive impairment that limits the ability to understand instructions or participate actively in the program","Unstable psychiatric disorders that may compromise adherence to or continuity with the exercise regimen","Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program","Participation in another pulmonary rehabilitation program within the 6 months prior to study enrollment"],"whatHappens":"If you join, the listed intervention(s) are Interdisciplinary intervention. The registry lists allocation as randomized. Introduction: Pulmonary rehabilitation programs (PRPs) are known to reduce symptoms such as dyspnea and fatigue, while improving functional capacity and quality of life in individuals with chronic obstructive pulmonary disease (COPD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 86 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.660Z"},{"nctId":"NCT07397715","title":"Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms","officialTitle":"Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms (MUSA 3)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Swiss GO Trial Group","sponsorClass":"NETWORK","summary":"The goal of this study/research is to assess the relationship between ultrasound features of the myometrium suggestive of adenomyosis and clinical symptoms of adenomyosis and to establish a reporting system for adenomyosis assessing disease severity. Consecutive pre- and perimenopausal symptomatic and asymptomicasymptomatic women with an uterus presenting for gynaecological ultrasound exams will be asked to participate in the study. Routine gynecologicalgynaecological ultrasound exams will be performed and study participants will fill out a questionnaire on their symptoms (if any) and bleeding pattern. There will be one visit and no interventions.","conditions":["Adenomyosis of Uterus"],"keywords":["Adenomyoma","Deep infiltrating endometriosis","Gynaecological transvaginal ultrasound","Gynaecological Ultrasound","Myometrium","Uterine anomaly","Asymptomatic adenomyosis","Symptomatic adenomyosis","Menstrual bleeding","Bleeding disorders","Abnormal uterine bleeding","Abdominal pain","Dysmenorrhoea","Dyspareunia","Morphological Uterus Sonographic Assessment (MUSA)","Adenomyosis Grading","Subfertility","Ultrasound features","Myometrial cysts","Hyperechogenic island","Echogenic subendometrial lines and buds","Globular uterus","Asymmetrical myometrial thickening","Fan shaped shadowing","Cyclical/non-cyclical bleeding","menorrhagia","Metrorrhagia","Translesional vascularity","Irregular junctional zone","Interrupted junctional zone","benign fibroid","Myoma"],"interventions":[],"enrollment":1000,"startDate":"2024-03-15","completionDate":"2028-02-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.\n* Symptomatic and asymptomatic women\n* Patients with hormonal contraceptives and Hormone Replacement Therapy (HRT) can be included, but information will be noted.\n\nExclusion Criteria:\n\n* Missing written consent (study consent)\n* Any serious underlying medical, psychiatric or psychological condition, which may interfere with the patient's capacity of discernment.\n* Postmenopausal women\n* Pregnancy\n* History of pelvic urogynaecologic surgery (TVT, mesh surgery, etc.)\n* Malignancy or premalignancy of uterus/cervix\n* Prior myomectomy for FIGO 3-6 fibroids\n* Patients with coagulation disorders under current anticoagulation medication\n* Prior history of diagnosed intraabdominal adhesions (surgery)\n* Prior diagnosis of pelvic congestion syndrome\n* Psychiatric disease precluding a reliable estimation of pain\n* Prior surgery or treatment for deep infiltrating endometriosis\n* Acute other symptoms:\n* Urinary symptoms (dysuria, urgency, grade III stress incontinence)\n* Acute of chronic pelvic infection (cervicitis, endometritis, salpingitis, frozen pelvis)\n* Ovarian lesions\n* Sonographic signs of deep infiltrating endometriosis (DIE)\n* Intracavitary pathology (Fibroid 0-2, polyp, adhesions)\n* Retained products of conception\n* \\>3 small fibroids below 2 cm in largest diameter FIGO 3-8 (i.e. the presence of three fibroids below 2cm is NOT considered an exclusion criterion)\n* Presence of any fibroid \\>2cm.","locations":[{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of Silesia","city":"Sosnowiec","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Dexeus","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"Canton of Basel-City","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Winterthur","city":"Winterthur","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gwendolin Manegold-Brauer, Prof. Dr.","phone":"+41612659046","email":"gwendolin.manegold-brauer@usb.ch"},{"name":"Team Swiss GO Trial Group, +41613284203","phone":"","email":"pm-team@swiss-go.ch"}],"primaryOutcomes":["Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms."],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["leuven-belgium","sosnowiec-poland","barcelona-spain","basel-switzerland","winterthur-switzerland"],"enrichment":{"headline":"Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms","inPlainEnglish":"The goal of this study/research is to assess the relationship between ultrasound features of the myometrium suggestive of adenomyosis and clinical symptoms of adenomyosis and to establish a reporting system for adenomyosis assessing disease severity. Consecutive pre- and perimenopausal symptomatic and asymptomicasymptomatic women with an uterus presenting for gynaecological ultrasound exams will be asked to participate in the study.","whoItsFor":["Ages 18 Years to any","Women only","Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent","Symptomatic and asymptomatic women","Patients with hormonal contraceptives and Hormone Replacement Therapy (HRT) can be included, but information will be noted"],"whoShouldSkip":["Missing written consent (study consent)","Any serious underlying medical, psychiatric or psychological condition, which may interfere with the patient's capacity of discernment","Postmenopausal women","History of pelvic urogynaecologic surgery (TVT, mesh surgery, etc.)","Malignancy or premalignancy of uterus/cervix","Prior myomectomy for FIGO 3-6 fibroids","Patients with coagulation disorders under current anticoagulation medication"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.111Z"},{"nctId":"NCT07398417","title":"Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design","officialTitle":"A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Assess the Efficacy and Safety of AXS-14 in the Management of Fibromyalgia","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Axsome Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The study is a Phase 3, double-blind, placebo-controlled, randomized withdrawal study to assess the efficacy and safety of AXS-14 in the management of fibromyalgia.","conditions":["Fibromyalgia"],"keywords":["Fibromyalgia","Central Sensitization","Allodynia","Hyperalgesia","Hypersensitivity to sensory stimuli","Inhibitor of the norepinephrine transporter (NET)","Esreboxetine","AXS-14","Axsome","Norepinephrine reuptake inhibitor"],"interventions":[{"type":"DRUG","name":"AXS-14 (Esreboxetine)"},{"type":"DRUG","name":"Placebo"}],"enrollment":620,"startDate":"2026-01-14","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria.\n* Male or female, ≥18 years of age.\n* Provides written informed consent to participate in the study before conducting any study procedures.\n\nExclusion Criteria:\n\n* Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition.\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","locations":[{"facility":"Clinical Research Site","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Cromwell","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Norcross","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Tinley Park","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Hazelwood","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Town and Country","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Hartsdale","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Williamsville","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"High Point","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Huber Heights","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Milford","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Plymouth Meeting","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Cranston","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Prosper","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"212-332-5061","email":"AXS-14-FM-301@axsome.com"}],"primaryOutcomes":["Time from randomization to loss of therapeutic response"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["glendale-arizona","phoenix-arizona","tucson-arizona","little-rock-arkansas","anaheim-california","oceanside-california","redlands-california","sacramento-california","santa-ana-california","cromwell-connecticut","hollywood-florida","jacksonville-florida","lakeland-florida","maitland-florida","orlando-florida","tampa-florida","the-villages-florida","atlanta-georgia","marietta-georgia","norcross-georgia","chicago-illinois","tinley-park-illinois","kansas-city-kansas","overland-park-kansas","louisville-kentucky","prairieville-louisiana","rockville-maryland","boston-massachusetts","north-dartmouth-massachusetts","watertown-massachusetts","hazelwood-missouri","springfield-missouri","town-and-country-missouri","las-vegas-nevada","brooklyn-new-york","hartsdale-new-york","williamsville-new-york","high-point-north-carolina","huber-heights-ohio","milford-ohio","tulsa-oklahoma","duncansville-pennsylvania","plymouth-meeting-pennsylvania","cranston-rhode-island","charleston-south-carolina","knoxville-tennessee","memphis-tennessee","austin-texas","dallas-texas","houston-texas","prosper-texas","san-antonio-texas","the-woodlands-texas"],"enrichment":{"headline":"Phase 3: testing AXS-14 (Esreboxetine) for Fibromyalgia","inPlainEnglish":"The study is a Phase 3, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned withdrawal study to assess the how well it works and safety of AXS-14 in the management of fibromyalgia.","whoItsFor":["Ages 18 Years to any","Has a primary diagnosis of fibromyalgia based on the 2016 ACR diagnostic criteria","Male or female, ≥18 years of age"],"whoShouldSkip":["Previous participation in a clinical trial with reboxetine or esreboxetine or currently receiving treatment with reboxetine for any condition","Unable to comply with study procedures","Medically inappropriate for study participation in the opinion of the investigator"],"whatHappens":"If you join, the listed intervention(s) are AXS-14 (Esreboxetine), or Placebo. The registry lists allocation as randomized. The study is a Phase 3, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, randomly assigned withdrawal study to assess the how well it works and safety of AXS-14 in the management of fibromyalgia.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 620 people at 53 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.780Z"},{"nctId":"NCT07399496","title":"Accelerated rTMS for Apathy in Parkinson's Disease","officialTitle":"Accelerated rTMS for Apathy in Parkinson's Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Medical University of South Carolina","sponsorClass":"OTHER","summary":"This single-site, open-label pilot study will evaluate the feasibility, tolerability, and preliminary efficacy of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits. Outcomes include adherence, tolerability, changes in apathy (Lille Apathy Rating Scale), functional engagement, and neural target engagement assessed via resting-state fMRI and EEG. Follow-up assessments will occur at one week, two weeks, and four weeks post-treatment. Fifteen participants with PD without clinically significant apathy will act as a comparison group and will undergo imaging (EEG and MRI), assessments, and questionnaires at baseline. Caregivers for each participant will complete questionnaires regarding their co-participant's symptoms as well as answer questions about their experience as a caregiver.","conditions":["Parkinson Disease","Apathy"],"keywords":["Neuromodulation","iTBS","Transcranial Magnetic Stimulation","Apathy","Parkinson's Disease"],"interventions":[{"type":"DEVICE","name":"Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC)"}],"enrollment":30,"startDate":"2026-09-09","completionDate":"2027-09-09","sex":"ALL","minAge":"45 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"PD Apathy Participant\n\nInclusion criteria:\n\n1. 45-85 years of age\n2. Diagnosis of PD based on UK Brain Bank diagnostic criteria\n3. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37\n4. Stable on Parkinsons medications (not expected to change through the course of the treatment)\n5. Ability to have a co-participant/caregiver who meets criteria below.\n\nExclusion Criteria:\n\n1. Claustrophobia or inability to lie supine in the scanner for an extended period of time\n2. barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)\n3. Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings.\n4. Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder.\n5. Pregnancy\n6. Individuals with a history of seizure(s).\n7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (\\<21)\n8. Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year\n\nCo-participant/Caregiver\n\nInclusion Criteria:\n\n1. 18 years of age or older\n2. Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's apathy and everyday functioning.\n\nExclusion criteria:\n\n1\\) Unable to engage with study procedures in which co-participant input is needed.\n\nPD Control Group\n\nInclusion Criteria:\n\n1. Age matched to participants in the PD Apathy group (45 to 85 years of age)\n2. Diagnosis of PD based on UK Brain Bank diagnostic criteria \\[17\\]\n3. Stable on Parkinsons medications (not expected to change through the course of the study)\n\nExclusion Criteria:\n\n1. Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37\n2. Claustrophobia or inability to lie supine in the scanner for an extended period of time\n3. Contraindications to MRI safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings\n4. Neuropsychiatric disorder diagnosis\n5. Uncorrected visual or hearing impairments, as indicated by self-report\n6. Pregnancy\n7. Presence of cognitive impairment or dementia that would impact participant's capacity to give informed consent or ability to participate in study procedures as indicated by chart review and/or measured by the MoCA (\\<21)\n\nCo-participant/Caregiver\n\nInclusion Criteria:\n\n3\\) 18 years of age or older 4) Is a reliable informant who has at least weekly contact with the participant and can speak to the participant's mood and everyday functioning.\n\nExclusion criteria:\n\n2\\) Unable to engage with study procedures in which co-participant input is needed.","locations":[{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["TMS adherence","Frequency and Severity of TMS-Induced Side effects (TMS tolerability and acceptability)","Apathy severity as measured by the Lille Apathy Rating Scale","Target engagement (dmPFC network modulation)"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["charleston-south-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC) for Parkinson Disease","inPlainEnglish":"This single-site, open-label pilot study will measure the feasibility, tolerability, and preliminary how well it works of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD). Fifteen participants with PD and clinically significant apathy will undergo imaging (EEG and MRI) and one day of TMS including twelve iTBS sessions across two visits.","whoItsFor":["Ages 45 Years to 85 Years","PD Apathy Participant","Diagnosis of PD based on UK Brain Bank diagnostic criteria","Symptomatic apathy as confirmed by a total score on the Apathy Evaluation Scale by the participant or the caregiver/co-participant (AES) of ≥37","Stable on Parkinsons medications (not expected to change through the course of the treatment)","Ability to have a co-participant/caregiver who meets criteria below"],"whoShouldSkip":["Claustrophobia or inability to lie supine in the scanner for an extended period of time","barriers to making contact between the TMS coil and the skin (e.g. braids that cannot be removed)","Contraindications to MRI/TMS safety screening: This includes but is not limited to implanted medical devices (e.g., pacemakers), metallic objects or fragments, and non-removable hair clips or piercings","Individuals with a diagnosis of bipolar disorder, schizophrenia, and/or active substance abuse disorder","Individuals with a history of seizure(s)","Acute suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) or suicide attempt in the previous year","Co-participant/Caregiver"],"whatHappens":"If you join, the listed intervention(s) are Accelerated intermittent theta-burst stimulation (iTBS) rTMS to left dorsomedial prefrontal cortex (dmPFC). The registry lists allocation as na. This single-site, open-label pilot study will measure the feasibility, tolerability, and preliminary how well it works of accelerated intermittent theta-burst stimulation (iTBS) targeting the dorsomedial prefrontal cortex (dmPFC) for apathy in individuals with Parkinson's Disease (PD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Charleston. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.669Z"},{"nctId":"NCT07399665","title":"ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia","officialTitle":"Open-label Single-arm, Non-interventional, Multi-centre Study for Evaluation of Clinical and Patient Reported Outcomes in Adult Patients With CRSwNP on Tezepelumab","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"ARES is a multi-centre, retrospective-prospective, non-comparative and non-interventional (observational) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).","conditions":["Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","Asthma"],"keywords":["Tezepelumab","CRSwNP"],"interventions":[],"enrollment":110,"startDate":"2025-12-25","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged 18 years or older at the time of signing the ICF.\n2. Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation.\n3. Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use / nasal polyps surgery (or information about contraindications / intolerance to).\n4. Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks.\n5. The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment.\n6. Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment.\n7. SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment.\n8. Currently receive care from specialist physicians (e.g., otolaryngologist) at the Investigator's or sub-Investigator's site.\n9. Provision of signed and dated written informed consent.\n10. Participants are able to read, understand and complete the questionnaires required by the protocol.\n\nExclusion Criteria:\n\n1. Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator.\n2. Administration of concurrent biologic drug for CRSwNP / asthma since the index date, except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment). Enrolment of patients who were switched from other biologic(s) to tezepelumab is allowed, and an acceptable timeframe since the last prior biologic drug is ≥ 60 days. The number of participants with prior biologic treatment (switching to tezepelumab) should be targeted at 20% or less.\n3. Participation in an observational study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months.\n4. Pregnancy or lactation period.","locations":[{"facility":"Research Site","city":"Kazan'","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kemerovo","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Krasnoyarsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lermontov","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Moscow","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rostov-on-Don","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ryazan","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Saint-Petesburg","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ulyanovsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yekaterinburg","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["1. Change in endoscopic status of CRSwNP based on NPS","2. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)","3. Change in endoscopic status of CRSwNP based on NPS","4. Change in a nasal congestion status based on Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22)"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["kazan-russia","kemerovo-russia","krasnoyarsk-russia","lermontov-russia","moscow-russia","rostov-on-don-russia","ryazan-russia","saint-petesburg-russia","ulyanovsk-russia","yekaterinburg-russia"],"enrichment":{"headline":"ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia","inPlainEnglish":"ARES is a multi-centre, retrospective-prospective, non-comparative and non-treatment (watch-and-measure (no experimental treatment required)) cohort study involving primary and secondary data collection within real-world settings of participants who have initiated tezepelumab (no more than 4 weeks before inclusion) for treatment of CRSwNP (with or without comorbid asthma).","whoItsFor":["Ages 18 Years to any","Male or female participants aged 18 years or older at the time of signing the ICF","Diagnosis of CRSwNP established for at least 52 weeks prior to tezepelumab initiation","Availability of participants' medical records for at least 52 weeks prior to tezepelumab initiation, including history of sCS use / nasal polyps surgery (or information about contraindications / intolerance to)","Prescribed and initiated treatment with tezepelumab according to SmPC and local market reimbursement criteria. A period between treatment initiation and enrolment should be no more than 4 weeks","The severity of CRSwNP consistent with need for surgery as defined by total NPS ≥ 5 (at least 2 for each nostril) at the enrollment","Nasal Blockage score as part of SNOT-22 (NBS-SNOT-22) ≥ 3 at the enrollment","SNOT-22 total score ≥ 30 at enrollment or up to 12 weeks before enrollment"],"whoShouldSkip":["Any contraindication to tezepelumab as per the approved product SmPC in Russia or in the opinion of the Investigator","Participation in an watch-and-measure (no experimental treatment required) study that might, in the Investigator's opinion, influence the assessment for the current study, or participation in an treatment clinical trial in the last 3 months","Pregnancy or lactation period"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 110 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.863Z"},{"nctId":"NCT07403058","title":"Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction","officialTitle":"Endovascular Ablation Of The Right Greater Splanchnic Nerve In Subjects Having Heart Failure With Reduced Ejection Fraction: Randomized Controlled Feasibility Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Axon Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"This study is a small, early-stage clinical trial designed to test whether a new catheter-based procedure is safe and may help people with heart failure with reduced ejection fraction (HFrEF). The procedure uses the Satera Ablation System to treat the right greater splanchnic nerve, which may play a role in heart failure symptoms. The study also aims to identify which types of patients might benefit most from this treatment in the future.\n\nUp to 50 patients aged 40 or older with HFrEF will take part at as many as 10 hospitals worldwide. The study is prospective, meaning patients are followed forward in time, and it is randomized, double-blinded, and sham-controlled. Patients are randomly assigned in a 2:1 ratio to either receive the actual nerve ablation treatment or a sham (placebo) procedure. Randomization happens during the procedure, after anesthesia or sedation, to reduce the risk of revealing which treatment the patient receives.\n\nNeither the patient nor their heart failure doctor will know whether the patient received the real treatment or the sham. However, the doctor performing the procedure and certain study staff will know, mainly for safety and operational reasons.\n\nThe sham procedure is designed to mimic the real procedure as closely as possible without performing the nerve ablation. It involves placing a small needle in the groin or neck and accessing the vein, but no treatment catheter is inserted. The sham procedure takes about the same amount of time as the real treatment (around 45 minutes) to help account for any placebo effect.\n\nOverall, this study is focused on evaluating safety and early signs of benefit rather than proving long-term effectiveness.","conditions":["Heart Failure With Reduced Ejection Fraction (HFrEF)"],"keywords":["Heart Failure","Reduced Ejection Fraction","Right Greater Splanchnic Nerve (GSN)"],"interventions":[{"type":"DEVICE","name":"Right Greater Splanchnic Nerve (GSN) ablation"},{"type":"PROCEDURE","name":"Sham Control"}],"enrollment":50,"startDate":"2026-06-12","completionDate":"2028-03-01","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Chronic heart failure, defined as:\n\n   1. Symptoms of HF requiring current (QD or QOD or appropriate dosing as per screening committee) treatment with loop diuretics for at least 30 days prior to screening visit, AND\n   2. NYHA class II, NYHA class III, or ambulatory NYHA class IV symptoms at screening or signs of HF, AND\n   3. NT-proBNP \\>800 pg/ml in normal sinus rhythm (\\>1400 pg/ml in atrial fibrillation or flutter) within 3 months of consent, with no adjustment for BMI\n2. Ongoing stable GDMT HF management for a minimum of 30 days prior to screening (unless unable to tolerate GDMT) which refers to those HF drugs carrying a Class I indication, including:\n\n   1. An inhibitor of the renin-angiotensin system (RAS inhibitor), including an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and beta-blocker (BB).\n   2. A mineralocorticoid receptor antagonist (MRA), Sodium-Glucose Transport 2 inhibitor (SGLT2i), or nitrates/hydralazine, should be used in appropriate patients, according to the published guidelines unless intolerant or not indicated.\n   3. Drug intolerance, contraindications, or lack of indications must be attested to by the investigator. Patients should be on appropriate doses of diuretics as required for volume control.\n   4. Stable GDMT refers to consistent dose (change is considered a more than 100% increase or 50% decrease in dose) for at least 30 days prior to screening visit or as appropriate per the screening committee.\n3. Participants cannot have started a glucagon-like peptide (GLP)-1 or gastric inhibitory peptide (GIP) agonist within the last 6 months or plan to start a GLP-1 or GIP agonist within the ensuing 6 months after enrollment.\n4. Considered for Class I recommended cardiac rhythm management device therapy. Specifically: if indicated by class I guidelines, cardiac resynchronization therapy (CRT), an implanted cardioverter- defibrillator (ICD) or a pacemaker should be implanted at least 3 months prior to enrollment. These criteria may be waived if a patient is clinically contraindicated for these therapies or refuses them and must be attested to by the investigator.\n5. LVEF 20% - 40% (at screening visit and determined by echo core lab).\n6. Age ≥40 years.\n7. Subject is willing and able to provide appropriate study-specific informed consent, follow protocol procedures, and comply with follow-up visit requirements.\n\nExclusion Criteria:\n\n1. MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization.\n2. Cardiac resynchronization therapy initiated within 3 months prior to enrollment.\n3. Advanced heart failure defined as one or more of the following:\n\n   1. ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF.\n   2. Inotropic infusion (continuous or intermittent) within 6 months prior to screening.\n   3. Subject is on the cardiac transplant waiting list or has undergone transplant.\n   4. Presence of, or history of, mechanical circulatory support for HF.\n   5. Planned other advanced HF Therapies in the next 12 months.\n4. Right heart dysfunction defined as tricuspid annular plane systolic excursion (TAPSE) \\<12 mm or right ventricular (RV) fractional area change (FAC) \\<25% (at screening visit and determined by echo core lab).\n5. Body mass index (BMI) \\>45 kg/m2.\n6. 6-minute walk test distance \\<100 meters OR \\>450 meters.\n7. Admission for HF within the 30 days prior to planned index procedure.\n8. Any known history of orthostatic hypotension or orthostatic hypotension at the time of screening (regardless of the presence of symptoms). Orthostatic hypotension is defined as a systolic blood pressure (BP) decrease of \\>20 mmHg upon going from supine to standing position or undergoing treatment with Midodrine.\n9. Orthostatic pulse pressure narrowing from supine to standing (+3 minutes) of ≥10mmHg in the absence of a HR increase \\>15bpm\n10. Postural orthostatic tachycardia syndrome or preload insufficiency syndrome or on medical therapy for neurogenic orthostatic hypotension (e.g., midodrine, droxidopa).\n11. Systolic BP \\<100 mmHg or \\>170 mmHg despite appropriate medical management.\n12. Baseline screening ECG resting HR \\>100 beats per minute or ventricular tachycardia.\n13. Catheter ablation for atrial fibrillation within 6 months prior to screening or planned in the next 12 months at the time of screening.\n14. Presence of significant valve disease defined by the site cardiologist as:\n\n    1. Greater than mild mitral valve stenosis.\n    2. Greater than moderate mitral valve regurgitation.\n    3. Greater than moderate-to-severe tricuspid valve regurgitation.\n    4. Greater than moderate aortic valve stenosis or regurgitation.\n15. Any planned procedure to address valve disease in the past 6 months.\n16. Known hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or other infiltrative cardiomyopathy (e.g., hemochromatosis, sarcoidosis).\n17. History of clinically significant liver cirrhosis.\n18. Prior weight loss surgery\n19. Dialysis dependent; or estimated GFR \\<20 ml/min/1.73 m2 by CKD-EPI creatinine equation.\n20. Arterial oxygen saturation \\<90% on room air.\n21. Chronic pulmonary disease requiring continuous home oxygen OR hospitalization for exacerbation of chronic pulmonary disease (including intubation) in the 12 months before study entry OR known history of GOLD Class III or worse chronic obstructive pulmonary disease (COPD).\n22. Participating in conflicting investigational drug or device study that is not completed within 30 days prior to the screening visit.\n23. Life expectancy \\<12 months for non-cardiovascular reasons.\n24. Any condition, or history of illness or surgery that, in the opinion of the site investigator or Screening Committee, might confound the results of the study or pose additional risks to the patient.\n25. Females who are pregnant or lactating or planning to become pregnant during the next year.\n26. LVEDD \\> 7.5 cm (at screening visit and determined by echo core lab)\n27. Estimated peak pulmonary artery pressure (PAP) \\> 70 mmHg (at screening visit and determined by echo core lab).\n\n    Exclusion Criteria Assessed During the index procedure:\n28. Vessel tortuosity or variant vascular anatomy that could preclude the access or maneuvering of the interventional device from the access site to target vessel. This includes previous spine surgery that may impact the ability to access and treat the target sites of T11 and T10.","locations":[{"facility":"Motol and Homolka University Hospital","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heart and Vascular Clinic","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tbilisi Heart Center","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wrocławiu","city":"Wroclaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Quirónsalud Barcelona","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico Universitario de Valencia-INCLIVA","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vithas Valencia Turia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leeds General Infirmary","city":"Leeds","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"King's College London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Judit Adorjan","phone":"+1 650 722-1119","email":"j.adorjan@axontherapies.com"}],"primaryOutcomes":["Device or procedure related serious adverse events","NT-proBNP (6 months)"],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["prague-czechia","tbilisi-georgia","wroclaw-poland","barcelona-spain","valencia-spain","leeds-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Right Greater Splanchnic Nerve (GSN) ablation for Heart Failure With Reduced Ejection Fraction (HFrEF)","inPlainEnglish":"This study is a small, early-stage clinical trial designed to test whether a new catheter-based procedure is safe and may help people with heart failure with reduced ejection fraction (HFrEF). The procedure uses the Satera Ablation System to treat the right greater splanchnic nerve, which may play a role in heart failure symptoms.","whoItsFor":["Ages 40 Years to any","Chronic heart failure, defined as:","Symptoms of HF requiring current (QD or QOD or appropriate dosing as per screening committee) treatment with loop diuretics for at least 30 days prior to screening visit, AND","NYHA class II, NYHA class III, or ambulatory NYHA class IV symptoms at screening or signs of HF, AND","NT-proBNP \\>800 pg/ml in normal sinus rhythm (\\>1400 pg/ml in atrial fibrillation or flutter) within 3 months of consent, with no adjustment for body-mass index (BMI)","Ongoing stable GDMT HF management for a minimum of 30 days prior to screening (unless unable to tolerate GDMT) which refers to those HF drugs carrying a Class I indication, including:","An inhibitor of the renin-angiotensin system (RAS inhibitor), including an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) and beta-blocker (BB)","A mineralocorticoid receptor antagonist (MRA), Sodium-Glucose Transport 2 inhibitor (SGLT2i), or nitrates/hydralazine, should be used in appropriate patients, according to the published guidelines unless intolerant or not indicated"],"whoShouldSkip":["MI (type I) and/or percutaneous cardiac intervention within 3 months prior to screening; CABG in past 3 months prior to screening, or current indication for coronary revascularization","Cardiac resynchronization therapy initiated within 3 months prior to enrollment","Advanced heart failure defined as one or more of the following:","ACC/AHA/ESC Stage D HF or non-ambulatory NYHA Class IV HF","Inotropic infusion (continuous or intermittent) within 6 months prior to screening","Subject is on the cardiac transplant waiting list or has undergone transplant","Presence of, or history of, mechanical circulatory support for HF"],"whatHappens":"If you join, the listed intervention(s) are Right Greater Splanchnic Nerve (GSN) ablation, or Sham Control. The registry lists allocation as randomized. This study is a small, early-stage clinical trial designed to test whether a new catheter-based procedure is safe and may help people with heart failure with reduced ejection fraction (HFrEF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at 9 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.430Z"},{"nctId":"NCT07403825","title":"Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material","officialTitle":"Efficacy of Faricimab in Patients With Subretinal Hyperreflective Material Associated With Type 2 or Mixed Neovascular Membranes Assessed by Multimodal Imaging","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Biobizkaia Health Research Institute","sponsorClass":"OTHER_GOV","summary":"Whose aim is to:\n\nDetermine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16.\n\nThis study is intended to be performed in the ophthalmology departments or ophthalmology clinics of the participating sites, located in Spain.\n\nMacular degeneration is an eye disease characterised by progressive damage to the macula leading to a loss of central vision. There are two types of macular degeneration, dry and wet or exudative. The prevalence of the latter in Spain is 1.9% in people aged 65 and over. Among the subtypes of macular neovascularisation (MNV), type 2 is rare (9%), with the majority being mixed type 1 and 2 cases (13.5%). SHRM is present in about 77% of eyes with neovascular age-related macular degeneration (AMD).\n\nDifferent anti-VEGF (vascular endothelial growth factor) drugs have been used for the treatment of type 2 and mixed 1 and 2 types of MNV. Following treatment, a reduction in SHRM has been observed, although results between studies vary between 34% and 56%. Improvements in best-corrected visual acuity are also achieved in eyes with type 2 MNV with anti-VEGF therapy.","conditions":["Macular Degeneration, Age Related"],"keywords":[],"interventions":[{"type":"DRUG","name":"Vabysmo 6 MG in 0.05 ML Injection"}],"enrollment":100,"startDate":"2026-05-25","completionDate":"2028-10","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* People aged 50 and over.\n* Diagnosed with bilateral or unilateral AMD.\n* Eyes with SHRM and type 2 or mixed (type 1 and 2) neovascular membrane.\n* Näive eyes treated with Faricimab following SmPC (summary of product characteristic).\n* They agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Eyes with type 1, aneurysmal type 1 and type 3 MNV.\n* Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum).\n* Eyes with ocular media opacity.\n* Patients with other retinal diseases, such as central serous chorioretinopathy, diabetic retinopathy, retinal vascular occlusion, uveitis, myopic maculopathy or any other retinal disease that could compromise the best-corrected visual acuity and interfere with retinal parameters.\n* Any neurological condition (including cognitive impairment, stroke, dementia, Parkinson, anxiety or schizophrenia) that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with the assessment, procedures, or completion of the study.\n* People who are participating or will participate in any type of clinical trial.\n* Pregnant women.\n* Breastfeeding women.\n* Women\\* of childbearing potential who are unable or unwilling to use highly effective methods of contraception (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) from the start to the end of the study.\n\n  * Woman of childbearing potential: considered as such if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), or has not undergone surgical sterilization (removal of ovaries and/or uterus).","locations":[{"facility":"Hospital Arruzafa","city":"Córdoba","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Basurto","city":"Bilbao","state":"Bizkaia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico Universitario de Valladolid","city":"Valladolid","state":"Castille and León","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Nuestra Señora del Perpétuo Socorro","city":"Albacete","state":"Castille-La Mancha","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Barraquer","city":"Barcelona","state":"Catalonia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínico San Carlos","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Puerta de Hierro Majadahonda","city":"Majadahonda","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oftalmologico Fernandez-Vega","city":"Oviedo","state":"Principality of Asturias","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oftalvist Valencia","city":"Burjassot","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Valencia","city":"Valencia","state":"Valencia","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["to assess the resolution of subretinal hyperreflective material (SHRM) at week 16"],"hasResults":false,"conditionSlugs":["als","macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["c-rdoba-spain","bilbao-spain","valladolid-spain","albacete-spain","barcelona-spain","madrid-spain","majadahonda-spain","oviedo-spain","burjassot-spain","valencia-spain"],"enrichment":{"headline":"Phase 4: testing Vabysmo 6 MG in 0.05 ML Injection for Macular Degeneration, Age Related","inPlainEnglish":"Whose aim is to: Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16. This study is intended to be performed in the ophthalmology departments or ophthalmology clinics of the participating sites, located in Spain.","whoItsFor":["Ages 50 Years to any","People aged 50 and over","Diagnosed with bilateral or unilateral AMD","Eyes with SHRM and type 2 or mixed (type 1 and 2) neovascular membrane","Näive eyes treated with Faricimab following SmPC (summary of product characteristic)"],"whoShouldSkip":["Eyes with type 1, aneurysmal type 1 and type 3 MNV","Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum)","Eyes with ocular media opacity","Any neurological condition (including cognitive impairment, stroke, dementia, Parkinson, anxiety or schizophrenia) that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with the assessment, procedures, or completion of the study","People who are participating or will participate in any type of clinical trial","Breastfeeding women"],"whatHappens":"If you join, the listed intervention(s) are Vabysmo 6 MG in 0.05 ML Injection. The registry lists allocation as na. Whose aim is to: Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.132Z"},{"nctId":"NCT07404085","title":"Epigenetic Enhancement of Cognitive Training in Aging Mood and Schizophrenia Spectrum Disorder Populations","officialTitle":"Epigenetic Priming to Enhance Cognitive Training Gains and Neuroplasticity in Middle-age and Older Adults With Mood or Schizophrenia Spectrum Disorders (EPIC)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","sponsorClass":"OTHER","summary":"The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders.\n\nThe investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs. a VR-based control treatment combined with placebo will improve global cognition (primary outcome measure) over three weeks.\n\nSecondly, the investigators hypothesize that VR-CRT with placebo will improve cognition relative to the VR control treatment with placebo, although to a lesser extent than VR-CRT with HDACi butyrate.\n\nThirdly, the investigators hypothesize that the HDACi butyrate with VR control treatment will not produce cognitive improvements relative to placebo with VR control treatment.\n\nFinally, the investigators hypothesize that the combined treatment (VR-CRT + HDACi butyrate) will enhance neuroplasticity (exploratory outcome) vs. VR control with placebo, as indicated by increase in hippocampal volume and/or memory-related activity shown with structural and functional MRI.","conditions":["Bipolar Disorder (BD)","Depression - Major Depressive Disorder","Cognitive Impairment","Schizophrenia Disorders"],"keywords":["Cognition","Cognitive impairment","Mood disorders","Cognitive decline","Neuroplasticity","Schizophrenia spectrum disorders"],"interventions":[{"type":"BEHAVIORAL","name":"Virtual Reality-based cognitive remediation therapy (VR-CRT)"},{"type":"BEHAVIORAL","name":"Virtual Reality-based control treatment (VR-CT)"},{"type":"DIETARY_SUPPLEMENT","name":"HDACi butyrate"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":160,"startDate":"2025-11-14","completionDate":"2027-07-01","sex":"ALL","minAge":"35 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14) or SSD assessed relatively stable by primary clinician at time of inclusion.\n* Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected norms)\n* Fluency in Danish language\n\nExclusion Criteria:\n\n* Neurological disorders (including dementia)\n* Dyslexia\n* Severe Physical illness\n* Kidney disease\n* Cardiovascular disease\n* Diabetes\n* Alcohol or substance abuse\n* Previous severe head trauma\n* History of epilepsy\n* Pregnancy or breastfeeding\n* BMI \\>35\n* Bodyweight \\< 45kg\n* Daily use of benzodiazepines \\> 22.5 mg. oxazepam or \\> 7.5 mg. diazepam per day\n* Serum lithium levels \\> 0.8 mmol/L\n* Received electroconvulsive therapy \\< 2 months prior to participation\n* Hypertension (\\>140 systolic or \\> 90 diastolic mm Hg)","locations":[{"facility":"Neurocognition and Emotion Across Disorders (NEAD Brain Centre, Copenhagen Affective Disorder Research Centre (CADIC), Psychiatric Centre Copenhagen, Frederiksberg Hospital","city":"Frederiksberg","state":"Capital Region of Denmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bjørn Ole Barkholt Nordseth, Ph.D.-student","phone":"+4527134653","email":"bjoern.ole.barkholt.nordseth@regionh.dk"},{"name":"Kamilla Woznica Miskowiak, DMSc, DPhil","phone":"+4522771617","email":"kamilla.woznica.miskowiak@regionh.dk"}],"primaryOutcomes":["Cognitive composite measure"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder","schizophrenia"],"drugSlugs":[],"locationSlugs":["frederiksberg-denmark"],"enrichment":{"headline":"Not a traditional drug phase: Virtual Reality-based cognitive remediation therapy (VR-CRT) for Bipolar Disorder (BD)","inPlainEnglish":"The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders. The investigators hypothesize that the VR-based cognitive remediation training (VR-CRT) combined with HDACi butyrate vs.","whoItsFor":["Ages 35 Years to 75 Years","Confirmed ICD-10 diagnosis of BD or recurrent UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14) or SSD assessed relatively stable by primary clinician at time of inclusion","Subjective cognitive complaints (self-reported: COBRA ≥12) or objectively-verified cognitive impairment (measured using Screening for Cognitive Impairment in Psychiatry SCIP: total score or at least two subscores ≥ 0.5 SD below expected norms)","Fluency in Danish language"],"whoShouldSkip":["Neurological disorders (including dementia)","Severe Physical illness","Cardiovascular disease","Alcohol or substance abuse","Previous severe head trauma","History of epilepsy","Pregnancy or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Virtual Reality-based cognitive remediation therapy (VR-CRT), Virtual Reality-based control treatment (VR-CT), or HDACi butyrate. The registry lists allocation as randomized. The aim of this clinical trial is to investigate the effects of a three-week virtual reality-based cognitive remediation training (VR-CRT) programme in combination with daily intake of a histone deacetylase inhibitor (HDACi) sodium butyrate on cognition in symptomatically stable patients with mood (depression or bipolar disorder; MD) or schizophrenia spectrum disorders.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 160 people at Frederiksberg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.745Z"},{"nctId":"NCT07405151","title":"A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F)","officialTitle":"A Phase 2 Open-Label, Umbrella Platform Design Study of Investigational Agent(s) in Participants With 2L/3L Unresectable Locally Advanced or Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06F","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.\n\nThe goal of this trial is to learn how many participants who receive I-DXd have the cancer respond, which means the cancer gets smaller or goes away.","conditions":["Oesophageal Squamous Cell Carcinoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"I-DXd"},{"type":"DRUG","name":"Rescue Medication"}],"enrollment":60,"startDate":"2026-03-27","completionDate":"2027-06-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)\n* Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC\n* Has measurable disease\n* If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy\n* Has adequate organ function\n\nExclusion Criteria:\n\n* Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype\n* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention\n* Has clinically significant corneal disease\n* Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event\n* If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has uncontrolled or significant cardiovascular disease\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has known active central nervous system metastases and/or carcinomatous meningitis\n* Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids or has current diagnosis of ILD or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has active infection requiring systemic therapy other than those permitted.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc), and potential pulmonary involvement caused by any autoimmune, connective tissue, or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), prior pneumonectomy, or requirement for supplemental oxygen","locations":[{"facility":"UPMC Hillman Cancer Center ( Site 3904)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Cancer ( Site 3301)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Nossa Senhora Da Conceicao ( Site 3300)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Arturo López Pérez ( Site 3400)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill ( Site 3401)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anhui Provincial Hospital ( Site 2506)","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer Hospital ( Site 2500)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated hospital of Xiamen University ( Site 2504)","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital ( Site 2501)","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xuzhou Central Hospital ( Site 2502)","city":"Xuzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital ( Site 2507)","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital ( Site 2511)","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Masarykuv onkologicky ustav ( Site 4000)","city":"Brno","state":"Brno-mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU-BREST Cavale Blanche ( Site 2104)","city":"Brest","state":"Finistere","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 2102)","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aichi Cancer Center ( Site 2702)","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kanagawa Cancer Center ( Site 2701)","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital ( Site 2700)","city":"Chūō","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo universitetssykehus, Radiumhospitalet ( Site 3501)","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center ( Site 2902)","city":"Goyang-si","state":"Kyonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 2901)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center ( Site 2900)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kantonsspital Graubünden-Medizin ( Site 3700)","city":"Chur","state":"Kanton Graubünden","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopitaux Universitaires de Geneve HUG ( Site 3701)","city":"Geneva","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital at Kaohsiung ( Site 3003)","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital ( Site 3007)","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital ( Site 3001)","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital ( Site 3000)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Cancer Center (NTUCC) ( Site 3010)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital ( Site 3005)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital - Linkou Branch ( Site 3006)","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine Siriraj Hospital ( Site 3102)","city":"Bangkoknoi","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chulalongkorn University ( Site 3104)","city":"Pathumwan","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Songklanagarind Hospital ( Site 3101)","city":"Hat Yai","state":"Changwat Songkhla","country":"Thailand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["pittsburgh-pennsylvania","natal-brazil","porto-alegre-brazil","santiago-chile","hefei-china","beijing-china","xiamen-china","zhengzhou-china","xuzhou-china","jinan-china","hangzhou-china","brno-czechia","brest-france","paris-france","nagoya-japan","yokohama-japan","ch-japan","oslo-norway","goyang-si-south-korea","seoul-south-korea","chur-switzerland","geneva-switzerland","kaohsiung-city-taiwan","taichung-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan","bangkoknoi-thailand","pathumwan-thailand","hat-yai-thailand"],"enrichment":{"headline":"Phase 1 / Phase 2: testing I-DXd for Oesophageal Squamous Cell Carcinoma","inPlainEnglish":"The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC). I-DXd is an antibody-drug conjugate (ADC).","whoItsFor":["Ages 18 Years to any","Has a histologically or cytologically confirmed diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC)","Has disease progression after 1 or 2 prior lines of systemic therapy for unresectable locally advanced or metastatic ESCC","Has measurable disease","If infected with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy","Has adequate organ function"],"whoShouldSkip":["Has histologically or cytologically confirmed adenocarcinoma or adenosquamous carcinoma subtype","Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention","Has clinically significant corneal disease","Has any of the following within 6 months before screening: cerebrovascular accident, transient ischemic attack, other arterial thromboembolic event","If infected with HIV, has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has uncontrolled or significant cardiovascular disease","Has a known additional malignancy that is progressing or has required active treatment within the past 3 years"],"whatHappens":"If you join, the listed intervention(s) are I-DXd, or Rescue Medication. The registry lists allocation as na. The purpose of this trial is to assess if ifinatamab deruxtecan (I-DXd) can treat esophageal squamous cell carcinoma (ESCC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 34 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.326Z"},{"nctId":"NCT07405606","title":"Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder","officialTitle":"Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder: A Pilot Randomized Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Centre for Addiction and Mental Health","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to determine the safety and efficacy of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (MDD) and Alcohol Use Disorder (AUD). The main question it aims to answer is:\n\n\\- What is the feasibility and safety of administering PAT in adults with MDD-AUD by evaluating recruitment, retention, tolerability, and safety?\n\nResearchers will compare the psilocybin (25 mg) and placebo groups to see if there are any significant differences in frequency of dropouts or serious adverse events.\n\nParticipants will:\n\n* be randomized to receive either psilocybin (25 mg) or placebo\n* visit the site (in-person and remotely) for a total of 14 times to complete study tasks\n* receive psilocybin-assisted therapy (PAT) at five various timepoints","conditions":["Major Depressive Disorder (MDD)","Alcohol Use Disorder (AUD)"],"keywords":["depression","psilocybin","alcohol use disorder"],"interventions":[{"type":"DRUG","name":"Psilocybin 25 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":30,"startDate":"2026-03-23","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Be between the ages of 18-65\n* Must be deemed to have capacity to provide informed consent;\n* Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;\n* Stated willingness to comply with all study procedures;\n* Be deemed in health compatible with the study procedures according to study physician;\n* Ability to take oral medication and be willing to adhere to the PAT regimen;\n* Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;\n* Fulfil Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5) criteria for a primary diagnosis of current single or recurrent episodes of MDD of at least moderate severity but without psychotic features and a comorbid AUD diagnosis (moderate or severe) using the SCID-5;\n* A score of at least 14 on the Hamilton Depression Rating Scale for Depression (HAMD);\n* Participants should not be interested in initiating standard pharmacotherapies for MDD or AUD. The need to start/resume standard pharmacotherapies will be reassessed at Week 6.\n* Individuals who are willing to and tapered off current antidepressant or IMAOs, antipsychotic and anti-alcohol/anti-craving medications for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so;\n* Individuals who are willing to and have tapered off current inhibitors of 5'-diphospho-glucuronosyltransferase (UGT)1A9 and 1A10, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs) for a minimum of 2-weeks (or more depending on the medication) prior to Baseline (V2) and for the duration of the study and whose physician confirms that it is safe for them to do so;\n* Agreement to adhere to Lifestyle Considerations (section 4.5) throughout study duration.\n\nExclusion Criteria:\n\n* Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding;\n* Presence of a relative or absolute contraindication to psilocybin, including a drug allergy, recent stroke history, uncontrolled hypertension (over 160/100 mmHG), low or labile blood pressure, recent myocardial infarction, cardiac arrhythmic, severe coronary artery disease, or moderate to severe renal or hepatic impairment.\n* Diagnosis of cirrhosis, AST or ALT elevations \\> 3x upper limit of normal; significant abnormal liver function that would preclude administration of psilocybin based on the judgement of the QI (assessed notably by bilirubin, albumin, alkaline phosphatase, GGT, and INR functions)\n* Any DSM-5 lifetime diagnosis of a schizophrenia-spectrum disorder; obsessive-compulsive disorder, psychotic disorder (unless substance induced or due to a medical condition), bipolar I or II disorder, paranoid personality disorder, borderline personality disorder, or neurocognitive disorder as determined by medical history and the SCID-5 clinical interview;\n* Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;\n* Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score \\> 9, or any other indication that the participant may experience medically complicated withdrawal from alcohol, such as a score of ≥4 in the Prediction of Alcohol Withdrawal Severity Scale.\n* Use benzodiazepines (with the exception of use of up to 2mg of lorazepam equivalent per day for insomnia and anxiety if it is not taken within 12 hours before the psilocybin dose (Week 2).\n* Have a DSM-5 diagnosis of substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) within the preceding 6 months;\n* Presence of baseline prolonged QTc (more than 0.45 seconds for males and 0.47 seconds for females) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;\n* Use of aldehyde dehydrogenase (ALDH) inhibitors and UDG modulators;\n* Use of hallucinogens in the past 5 years; or total hallucinogen use ≥10 times)\n* Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is \"yes\")\n* Any other clinically significant physical illness including chronic infectious diseases or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.\n* Participants that are responding to anti-alcohol or anti-craving medications","locations":[{"facility":"Centre for Addiction and Mental Health","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bernard Le Foll","phone":"+14165358501","email":"bernard.lefoll@camh.ca"},{"name":"Esther Kim","phone":"+14165358501","email":"esther.kim@camh.ca"}],"primaryOutcomes":["Adherence","Montgomery-Asberg Depression Rating Scale (MADRS)","Hamilton Depression Rating Scale (HAMD-17)","Quick Inventory of Depressive Symptomatology - Self Report (QUIDS-SR)","Alcohol Timeline Followback (TLFB)","Clinical Institute Withdrawal Assessment (CIWA)","Prediction of Alcohol Withdrawal Severity Scale (PAWSS)","Penn Alcohol Craving Scale (PACS)","Addiction Severity Index (ASI)"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 2: testing Psilocybin 25 mg for Major Depressive Disorder (MDD)","inPlainEnglish":"The goal of this clinical trial is to determine the safety and how well it works of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (major depression) and Alcohol Use Disorder (AUD). The main question it aims to answer is: \\- What is the feasibility and safety of administering PAT in adults with major depression-AUD by evaluating recruitment, retention, tolerability, and safety?","whoItsFor":["Ages 18 Years to 65 Years","Be between the ages of 18-65","Ability to read and communicate in English, such that their literacy and comprehension is sufficient for understanding the consent form and study questionnaires, as evaluated by study staff obtaining consent;","Stated willingness to comply with all study procedures;","Be deemed in health compatible with the study procedures according to study physician;","Ability to take oral medication and be willing to adhere to the PAT regimen;","Individuals who are capable of becoming pregnant: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation;","A score of at least 14 on the Hamilton Depression Rating Scale for Depression (HAMD);"],"whoShouldSkip":["Pregnant as assessed by a urine pregnancy test at Screening (V1) and Baseline (V2) or individual's that intend to become pregnant during the study or are breastfeeding;","Diagnosis of cirrhosis, AST or ALT elevations \\> 3x upper limit of normal; significant abnormal liver function that would preclude administration of psilocybin based on the judgement of the QI (assessed notably by bilirubin, albumin, alkaline phosphatase, GGT, and INR functions)","Any first-degree relative with a diagnosis of schizophrenia-spectrum disorder; psychotic disorder (unless substance-induced or due to a medical condition); or bipolar I or II disorder as determined by the family medical history form and discussions with the participant;","Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) score \\> 9, or any other indication that the participant may experience medically complicated withdrawal from alcohol, such as a score of ≥4 in the Prediction of Alcohol Withdrawal Severity Scale","Use benzodiazepines (with the exception of use of up to 2mg of lorazepam equivalent per day for insomnia and anxiety if it is not taken within 12 hours before the psilocybin dose (Week 2)","Have a DSM-5 diagnosis of substance use disorder (excluding alcohol, cannabis, tobacco and caffeine) within the preceding 6 months;","Presence of baseline prolonged QTc (more than 0.45 seconds for males and 0.47 seconds for females) or Torsade de Pointes as measured by the ECG or a history of long QTc syndrome or related risk factors;"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 25 mg, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to determine the safety and how well it works of psilocybin assisted Therapy (PAT) in individuals with comorbid Major Depressive Disorder (major depression) and Alcohol Use Disorder (AUD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Toronto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.096Z"},{"nctId":"NCT07407725","title":"Clinical Outcome Assessment for AT & BCI","officialTitle":"Development of a Clinical Outcome Assessment for Assistive Technologies and Brain-Computer-Interfaces","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Shirley Ryan AbilityLab","sponsorClass":"OTHER","summary":"Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools. This project seeks to address this gap by developing a standardized method to objectively assess or compare the functional benefit of these tools on digital independence, i.e., the ability to independently operate computers, phones, and other digital systems, by creating a unique Digital Assessment Interface (DAI).\n\nThis assessment will be a simulation of online and digital activities that prior work has determined is important to functional daily living in the digital domain. Participants will complete this assessment with various ATs and BCIs, and these scores will be used to create an index, which will be comprised of performance outcomes, clinician-reported outcomes, and patient-reported outcomes.\n\nThe tool aims to quantify and compare digital task performance across devices and user populations. The primary objective of this study is to develop an index. The index will quantify functional performance of individuals using various ATs and BCIs. The secondary objectives are to extensively evaluate the psychometric properties of the index, such as the validity, responsiveness, reliability, and floor/ceiling effects both globally and across different devices and impairment levels, ensuring that it can reliably measure the impact of an AT or BCI on a user's ability to independently operate digital systems; and to characterize the familiarization and use of specific BCI and AT systems with reference to a normative healthy control population.","conditions":["Spinal Cord Injury","ALS (Amyotrophic Lateral Sclerosis)"],"keywords":["iBCI","Brain Computer Interface","Assistive Technology","Clinical Outcome Assessment","dADL","digital activities of daily living"],"interventions":[{"type":"DEVICE","name":"Eye Tracker"},{"type":"DEVICE","name":"Mouth Operated Joystick"},{"type":"DEVICE","name":"Non-invasive electroencephalogram (EEG) Headset"},{"type":"DEVICE","name":"Implantable Brain-Computer-Interface"},{"type":"DEVICE","name":"Personal Assistive Technology"},{"type":"DEVICE","name":"Voice Control"}],"enrollment":60,"startDate":"2026-01-08","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device.\n\nBelow are listed the inclusion and exclusion criteria for each diagnostic group.\n\nSpinal Cord Injury (SCI):\n\nInclusion Criteria:\n\n* Age at or above 18 years old;\n* Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1);\n* Ability to communicate independently or with a support device, or with a legal representative;\n* Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.\n\nExclusion Criteria:\n\n* Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.\n\nAmyotrophic Lateral Sclerosis (ALS):\n\nInclusion criteria:\n\n* Age at or above 18 years old;\n* Diagnosis of amyotrophic lateral sclerosis;\n* Ability to communicate independently, with a support device, or with a legal representative;\n* Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.\n\nExclusion criteria:\n\n● Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.\n\nHealthy Controls:\n\nInclusion criteria:\n\n* Age at or above 18 years old;\n* No history of neurological or psychiatric disorders;\n* Ability to provide written informed consent;\n* Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed.\n\nExclusion criteria:\n\n* Participation in another trial that would conflict with the current study or clinical endpoint interference may occur;\n* Cognitive, visual, or auditory deficits that would interfere with study participation;\n* Current or prior diagnosis or condition that could confound study assessments.","locations":[{"facility":"Shirley Ryan AbilityLab","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arun Jayaraman, PT, PhD","phone":"312-238-6875","email":"ajayaraman@sralab.org"},{"name":"Richa Rai, PhD","phone":"312-238-6538","email":"rrai@sralab.org"}],"primaryOutcomes":["Performance Outcomes (PerfOs)","Demographics and Medical Intake Questionnaire","NASA Task Load Index","NASA Task Load Index - Clinician's perspective","System Usability Scale (SUS)","System Usability Scale (SUS) - Clinician's perspective","Qualitative Questionnaire","Psychosocial Impact of Assistive Devices (PIAD)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: Eye Tracker for Spinal Cord Injury","inPlainEnglish":"Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers. Clinicians and researchers currently lack a common framework to objectively quantify how much a given AT or BCI improves real-world function or to compare across tools.","whoItsFor":["Ages 18 Years to any","Enrollment will involve three different cohorts, namely a cohort of healthy participant, a cohort of ALS/SCI participant who underwent the implant of an invasive BCI device, and a cohort of ALS/SCI participants without any implanted BCI device","Below are listed the inclusion and"],"whoShouldSkip":["for each diagnostic group","Spinal Cord Injury (SCI):","who can join:","Age at or above 18 years old;","Diagnosis of spinal cord injury, at the level of T1 or above levels (between C1 and T1);","Ability to communicate independently or with a support device, or with a legal representative;","Ability to participate in a study session for about 3 hours (e.g., endurance, fatigue), which may include breaks as needed"],"whatHappens":"If you join, the listed intervention(s) are Eye Tracker, Mouth Operated Joystick, or Non-invasive electroencephalogram (EEG) Headset. The registry lists allocation as na. Many individuals with severe motor impairments rely on Assistive Technologies (ATs) or Brain-Computer Interfaces (BCIs) to interact with digital devices such as their computers.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Chicago. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.600Z"},{"nctId":"NCT07408206","title":"Sleep, Dreaming, and Virtual Reality for Mental Health","officialTitle":"Transformative Benefits of Contemplative Sleep Practices and a Novel Pathway to Deliver Benefits to the General Public","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"People spend approximately one-third of their lives asleep, yet sleep is often underused as an opportunity to support psychological well-being. Contemplative traditions, including Tibetan Dream Yoga, have developed practices that use waking imagination and lucid dreaming to explore perception, awareness, and habitual patterns of thinking. Recent advances in sleep monitoring, dream communication, and lucid dream induction now make it possible to study these practices using scientific methods.\n\nThis study is a randomized controlled trial designed to examine the feasibility and effects of a Dream-Yoga-inspired intervention compared with an active control condition. The intervention combines waking and dreaming practices that are adapted for individuals without prior experience and delivered using virtual reality-based training and home sleep technology. The program is designed to be scalable and culturally neutral, without requiring prior knowledge of contemplative or religious traditions.\n\nThe primary goals of the study are to characterize sleep and waking neurophysiology associated with Dream-Yoga-inspired practices and to evaluate whether participation is associated with changes in sleep-related brain activity and cognitive processes. Outcomes include measures of lucid dreaming, sleep physiology, and waking cognitive and perceptual processes. Anxiety will be assessed as an exploratory outcome to examine whether participation may be associated with changes in emotional experience. This study is not designed to provide treatment for anxiety or other clinical conditions.\n\nResults from this study will help inform the development of scalable sleep-based mental training approaches and guide future research on the use of dreaming and sleep practices to support psychological health and well-being.","conditions":["Anxiety"],"keywords":["lucid dreaming","dream yoga","contemplative practices","meditation","mind-body interventions"],"interventions":[{"type":"BEHAVIORAL","name":"Dream Yoga Inspired Intervention"},{"type":"BEHAVIORAL","name":"Sleep Health Enhancement Program (SHEP)"}],"enrollment":70,"startDate":"2026-01-15","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals interested in participating will be screened for eligibility through a Qualtrics survey, a Score between 5-21 points in GAD-7.\n\nHealthy, English-speaking adults (at least 18 years old) with high dream recall (at least 1/week).\n\nExclusion Criteria:\n\n* We will exclude people who self-report any of the following:\n\n  1. history of an established meditative practice\n  2. psychological or psychiatric disorders (other than mild anxiety)\n  3. sleep disorders, nightshift work in the past month, extreme chronotype or irregular sleeping pattern\n  4. use of recreational drugs in the past month\n  5. history of asthma, seizures or heart problems\n  6. unwillingness to wear headband during sleep","locations":[{"facility":"Northwestern University","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Contemplative Sciences Center","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"S. Gabriela Torres Platas, Ph.D.","phone":"(847) 491-3741","email":"gabriela.torresplatas@northwestern.edu"}],"primaryOutcomes":["Changes in frontal midline theta","Changes in Sleep Architecture"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["evanston-illinois","charlottesville-virginia"],"enrichment":{"headline":"Early phase 1: Dream Yoga Inspired Intervention for Anxiety","inPlainEnglish":"People spend approximately one-third of their lives asleep, yet sleep is often underused as an opportunity to support psychological well-being. Contemplative traditions, including Tibetan Dream Yoga, have developed practices that use waking imagination and lucid dreaming to explore perception, awareness, and habitual patterns of thinking.","whoItsFor":["Ages 18 Years to any","Individuals interested in participating will be screened for eligibility through a Qualtrics survey, a Score between 5-21 points in GAD-7","Healthy, English-speaking adults (at least 18 years old) with high dream recall (at least 1/week)"],"whoShouldSkip":["We will exclude people who self-report any of the following:","history of an established meditative practice","psychological or psychiatric disorders (other than mild anxiety)","sleep disorders, nightshift work in the past month, extreme chronotype or irregular sleeping pattern","use of recreational drugs in the past month","history of asthma, seizures or heart problems","unwillingness to wear headband during sleep"],"whatHappens":"If you join, the listed intervention(s) are Dream Yoga Inspired Intervention, or Sleep Health Enhancement Program (SHEP). The registry lists allocation as randomized. People spend approximately one-third of their lives asleep, yet sleep is often underused as an opportunity to support psychological well-being.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 70 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.352Z"},{"nctId":"NCT07409103","title":"A Study to Assess the Safety and Efficacy of Different Doses of ELV001 to Treat Active Rheumatoid Arthritis in Patients With an Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)","officialTitle":"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ELV001 as Add-on Therapy in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition (START SYNERGY)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Elevara Medicines Limited","sponsorClass":"INDUSTRY","summary":"This is a Phase 2 randomized, double-blind, placebo-controlled study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled. The number of participants can be extended to maximally 220 to account for dropouts during the study.","conditions":["Active Rheumatoid Arthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"ELV001 25 mg"},{"type":"DRUG","name":"ELV001 75 mg"},{"type":"DRUG","name":"ELV001 125 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":180,"startDate":"2026-02-18","completionDate":"2027-04-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provided written informed consent to participate to the study and are able and willing to adhere to the study protocol.\n2. Male or female, 18 to 75 years of age, at the time of signing the informed consent.\n3. Body mass index (BMI) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit.\n4. Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening.\n5. Have active RA defined by a DAS28-CRP ≥ 3.2 and the presence of ≥ 3 swollen joints (based on 66 joint count) and ≥ 3 tender joints (based on 68 joint count) at Screening and Baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility.\n6. Have C-reactive protein (CRP) ≥ upper limit of normal (ULN) at Screening.\n7. Have adequate hematologic function at Screening AND at Baseline.\n8. Have adequate liver and renal function at Screening.\n9. Are currently treated with MTX (methotrexate) with folic acid supplementation according to local standard-of-care. The maximum dose of MTX is 25 mg/week for oral use and 20 mg/week for parenteral use. The minimum dose is 15 mg/week, except in case of intolerance or side effects when doses of 7.5 mg/week or above are acceptable. MTX should have been used for at least 6 months, of which at least 3 months at a stable dose.\n10. Are currently treated with a TNFi for at least 6 months, of which at least 3 months at a stable dose. Participants should have demonstrated a partial response to the TNFi, as evidenced by the Investigator or treating physician based on DAS28-CRP, SDAI, CDAI or any other measure of disease activity as per local treatment guidelines.\n11. The following therapies for RA are permitted during the study, if the dose is stable for ≥ 4 weeks prior to Screening: hydroxychloroquine up to 400 mg/day, oral prednisone ≤ 7.5 mg daily or equivalent corticosteroid dose. Prior treatment with other csDMARDs, bDMARDs, or tsDMARD is permitted as long as these treatments have been stopped at least 2 months prior to Screening, with exception of cell depleting therapies (eg, rituximab), which should have been stopped at least 12 months prior to Screening.\n12. Female participants of childbearing potential must:\n\n    1. Have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to first dosing.\n    2. Use highly effective contraception from signing the informed consent until at least 90 days after the last dosing.\n    3. Not donate ova from signing the informed consent until at least 90 days after the last dosing.\n13. Male participants must use condoms and partners of childbearing potential must use highly effective contraception until at least 90 days after the last dosing. Male participants must not donate sperm until at least 90 days after the last dosing\n\nExclusion Criteria:\n\n1. Class IV RA according to ACR revised response criteria.\n2. Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi.\n3. Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator.\n4. Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline.\n5. Have oral prednisone \\> 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline.\n6. Have intra-articular corticosteroids within the last 4 weeks before Baseline.\n7. Had any other csDMARD, bDMARD, or immunosuppressive drug in the last 2 months.\n8. Had any cell depletion therapy (eg, rituximab) in the last 12 months.\n9. Have QT interval corrected for heart rate (QTc) using Fridericia's correction (QTcF) \\> 450 ms for males or QTcF \\> 470 ms for females either at Screening or Baseline, based on safety 12-lead electrocardiogram (ECG). Have a Screening or Baseline ECG with second- or third-degree atrioventricular block, bundle branch block, arrhythmia (but not sinus arrhythmia or supraventricular premature beats), or illegible QT interval.\n10. Have evidence of interstitial lung disease (ILD) based on either medical history, clinical signs and symptoms, imaging and/or lung function test, independently of the etiology of the ILD.\n11. Have a condition which could interfere with drug absorption including but not limited to short bowel syndrome.\n12. Have presence of 1 or more significant concurrent medical conditions, which could interfere with the treatment and/or the study per Investigator judgment, including but not limited to the following: poorly controlled diabetes or hypertension; chronic kidney disease stage IIIb, IV, or V; symptomatic heart failure (New York Heart Association class II, III, or IV); myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization; severe chronic pulmonary disease (eg, requiring oxygen therapy); and major chronic inflammatory disease or connective tissue disease other than RA.\n13. Have a history of chronic alcohol abuse, IV drug abuse or illicit drug abuse within 1 year before Screening.\n14. Have a diagnosis or history of malignant disease, with the exceptions of basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.\n15. Have had any surgical procedure (except for minor surgery requiring local or no anesthesia and without any complications or sequelae) within 12 weeks prior to Screening, or any planned surgical procedure scheduled to occur during the study.\n16. Have received a Bacillus Calmette-Guerin (BCG) vaccination or BCG treatment within 12 months of Screening; or received any other live vaccine(s) (ie, live attenuated) within 3 months of Screening, or intend to receive a live vaccine during the study.\n17. Have had any of the following types of infection within 3 months of Screening or develops any of these infections before the randomization visit:\n\n    * Serious (requiring hospitalization, and/or parenteral antibiotic treatment),\n    * Opportunistic, as defined in (Winthrop et al. 2015) (note, Herpes zoster infection is considered active and ongoing until all vesicles are dry and crusted over),\n    * Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer),\n    * Recurring (including, but not limited to herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis). Participants with recurrent nonserious infections such as cellulitis and uncomplicated orolabial and/or genital herpes may be enrolled at the discretion of the Investigator when deemed not to place participants at an increased risk of complications.\n18. Have any of the following:\n\n    * Human immunodeficiency virus (HIV) infection,\n    * Current infection with hepatitis B virus (HBV) (ie, positive for hepatitis B surface antigen and/or polymerase chain reaction \\[PCR\\] positive for HBV DNA),\n    * Current infection with hepatitis C virus (HCV) (ie, positive for HCV RNA),\n    * Active tuberculosis (TB).\n19. Have or have had latent TB infection (LTBI) that has not been treated with a complete course of appropriate therapy as defined by the World Health Organization (WHO) and/or the United States Centers for Disease Control and Prevention (CDC). Participants with LTBI who have been adequately treated are eligible for the study.\n20. Current or recent acute active infection (ie, participants must have had no symptoms and/or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment within 30 days of Baseline); or fever of 100.5°F (38°C) or above at Screening or Baseline.\n21. Any other concurrent severe and/or uncontrolled medical, surgical or psychiatric and/or social condition which, in the view of the Investigator, could compromise the participant's safety or ability to participate in the study and make them unsuitable for participation.\n22. Use of other investigational medicinal products within 12 weeks or at least 5 half-lives (whichever is longer) before study drug administration.\n23. Women who are pregnant or breast-feeding or planning to become pregnant during the study.","locations":[{"facility":"Arizona Arthritis & Rheumatology Associates","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Arthritis & Rheumatology Associates","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Arthritis & Rheumatology Associates","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Solace Clinical Research - Populace Health (Network)","city":"Tustin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Denver Arthritis Clinic","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rheumatology Associates of South Florida-Clinical Research Inc - Cliniverse Research (Network)","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prophase, LLC - Clinitiative Health Research (Network)","city":"Margate","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Millennium Medical Research LLC - Clinitiative Health Research (Network)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Floridian Clinical Research, LLC - Clinitiative Health Research (Network)","city":"Miami Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioresearch Partner - Cliniverse Research (Network)","city":"South Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research Inc (SMO/ Network)","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Center of Rheumatology","city":"Lansing","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DJL Clinical Research PLLC (Network) cIRB","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Arthritis Associates - Cliniverse Research (Network)","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altoona Arthritis & Osteoporosis Center","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pennsylvania Regional Center for Arthritis & Osteoporosis Research","city":"Wyomissing","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Management, LLC. - Accurate Clinical Research Inc (SMO/ Network)","city":"Baytown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research Inc (SMO/ Network)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heights Rheumatology and Aesthetics - ES Clinical Research Group Network","city":"Jackson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research-Red Oak","city":"Red Oak","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research (Network)","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Special Hospital for Rheumatic Diseases Novi Sad","city":"Novi Sad","state":"Vojvodina","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Rheumatology","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Military Medical Academy,Clinic for Rheumatology","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Panorama Medical Center","city":"Panorama","state":"Cape Town","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Arthritis Clinical Trial Centre","city":"Pinelands","state":"Capetown","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winelands Medical Research Centre - Somerset West (Dr Francois Bouwer INC)","city":"Somerset West","state":"Capetown","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRISMO Research Centre - Bertha Gxowa Hospital","city":"Germiston","state":"Gauteng","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Unit, University of Pretoria, Room 2-54, Pathology Building, Prinshof Medical Campus Dr. Savage Road, incorporating Steve Biko Hospital, Steve Biko Road","city":"Pretoria","state":"Gauteng","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Netcare Jakaranda Hospital Suite 102","city":"Pretoria","state":"Gauteng","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Netcare Umhlanga Medical Centre","city":"Durban","state":"KwaZulu-Natal","country":"South Africa","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winelands Medical Research Centre","city":"Stellenbosch","state":"Western Cape","country":"South Africa","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in Disease activity score 28- C-reactive protein between Baseline and Week 12."],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["gilbert-arizona","glendale-arizona","tucson-arizona","tustin-california","denver-colorado","boca-raton-florida","margate-florida","miami-florida","miami-beach-florida","south-miami-florida","lake-charles-louisiana","lansing-michigan","charlotte-north-carolina","wilmington-north-carolina","duncansville-pennsylvania","wyomissing-pennsylvania","baytown-texas","houston-texas","jackson-texas","red-oak-texas","tomball-texas","novi-sad-serbia","belgrade-serbia","panorama-south-africa","pinelands-south-africa","somerset-west-south-africa","germiston-south-africa","pretoria-south-africa","durban-south-africa","stellenbosch-south-africa"],"enrichment":{"headline":"Phase 2: testing ELV001 25 mg for Active Rheumatoid Arthritis","inPlainEnglish":"This is a Phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit. Approximately 180 participants are planned to be enrolled.","whoItsFor":["Ages 18 Years to 75 Years","Body mass index (body-mass index (BMI)) between 18.5 and 32.0 kg/m2 and minimum weight of 50 kg at the Screening Visit","Have a diagnosis of adult onset RA and fulfill the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (Aletaha et al. 2010) for at least 6 months prior to Screening","Have C-reactive protein (a blood inflammation marker (CRP)) ≥ upper limit of normal (ULN) at Screening","Have adequate hematologic function at Screening AND at Baseline","Have adequate liver and renal function at Screening","Female participants of childbearing potential must:","Have a negative serum pregnancy test at Screening and a negative urine pregnancy test within 24 hours prior to first dosing"],"whoShouldSkip":["Class IV RA according to ACR revised response criteria","Have been treated with more than 1 previous bDMARDs or tsDMARDs, excluding the current TNFi","Has a secondary non-response to the TNFi due to anti-drug antibodies, as assessed by the Investigator","Have a dose change of MTX or TNFi within the last 3 months before Baseline, or a dose change of hydroxychloroquine or oral prednisolone within the last 4 weeks before Baseline","Have oral prednisone \\> 7.5 mg/day equivalent or parenteral corticosteroids within the last 4 weeks before Baseline","Have intra-articular corticosteroids within the last 4 weeks before Baseline","Had any other csDMARD, bDMARD, or immunosuppressive drug in the last 2 months"],"whatHappens":"If you join, the listed intervention(s) are ELV001 25 mg, ELV001 75 mg, or ELV001 125 mg. The registry lists allocation as randomized. This is a Phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study with a total duration of 32 weeks from Screening to End-of-Study (EOS) Visit.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.962Z"},{"nctId":"NCT07409181","title":"A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)","officialTitle":"Randomised, Placebo-controlled, Double-blind, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of Oral BI 3000202 in Patients With Moderate to Severe Systemic Lupus Erythematosus (SLE)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.\n\nParticipants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE.\n\nParticipants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Lupus"],"interventions":[{"type":"DRUG","name":"BI 3000202"},{"type":"DRUG","name":"Placebo"}],"enrollment":405,"startDate":"2026-04-20","completionDate":"2029-02-04","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male and female adult patients from ≥18 years (or alternative age for adults based on local regulations) to \\<75 years\n2. Confirmed Systemic Lupus Erythematosus (SLE) diagnosis meeting the European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria at least 24 weeks prior to screening\n3. At least one of the following positive at screening: Antinuclear Antibodies (ANA) ≥1:80 or anti-double-stranded Deoxyribonucleic Acid (dsDNA) antibody or anti-Smith antibody\n\n   \\- Total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥6 points and clinical SLEDAI-2K score ≥4 points\n4. At least 1 British Isles Lupus Assessment Group (BILAG) A and/or 1 BILAG B grade at screening, with sufficient disease activity according to both investigator and adjudicator\n5. On SLE background therapy with a maximum of 1 immunosuppressant and/or 1 antimalarial for ≥8 weeks and at a stable dose for ≥4 weeks before screening and/or oral corticosteroids at a dose of ≤30 mg/day prednisone or equivalent, stable for ≥2 weeks before screening (Visit 1) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Drug-induced SLE\n2. Scleroderma (except linear scleroderma that does not interfere with assessments of SLE disease activity) or in the opinion of the investigator or adjudicator elements of other connective tissue disease that would interfere with interpretation of test results or SLE clinical assessments\n3. Active or unstable lupus neuropsychiatric manifestations, including but not limited to any condition as defined by BILAG A criteria in the neuropsychiatric system, with the exception of mononeuritis/mononeuropathy multiplex, chorea, and polyneuropathy\n4. Lupus nephritis that may require a change in immune-modulating treatment or which demonstrates serum creatinine that is unstable or \\>2 × Upper Limit of Normal (ULN) and/or Urine Protein Creatinine Ratio (UPCR) that is unstable or \\> 3mg/mg (339 mg/mmol)\n5. Oral corticosteroids (prednisone or equivalent) \\>30 mg/day at screening Further exclusion criteria apply.","locations":[{"facility":"Wallace & Lee Center","city":"Beverly Hills","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Arthritis & Osteoporosis Medical Center, Inc - La Palma","city":"La Palma","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Rheumatology Clinical Trials, Inc","city":"Upland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Focus Clinical 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The registry lists allocation as randomized. This study is open to adults with systemic lupus erythematosus (SLE).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 405 people at 139 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.283Z"},{"nctId":"NCT07409428","title":"A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL","officialTitle":"A Phase III Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hutchmed","sponsorClass":"INDUSTRY","summary":"This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with R/R DLBCL.","conditions":["Relapsed/Refractory Diffuse Large B-Cell Lymphoma"],"keywords":["HMPL-760","R-GemOx (rituximab, gemcitabine, and oxaliplatin)","R/R DLBCL"],"interventions":[{"type":"DRUG","name":"HMPL-760"},{"type":"DRUG","name":"HMPL-760 Placebo"},{"type":"DRUG","name":"R-GemOx"}],"enrollment":240,"startDate":"2026-03-20","completionDate":"2028-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Sign the ICF and be able to follow the requirements of study protocol;\n2. Age ≥18 years;\n3. ECOG performance status score between 0 and 2;\n4. Histopathologically confirmed diagnosis of DLBCL;\n5. The investigator judges that the patient's current condition requires further treatment;\n6. Patients should have at least one bi-dimensionally measurable lesion;\n7. Expected survival is more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;\n2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;\n3. Organ insufficiency;\n4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);\n5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;\n6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);\n7. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);\n8. Clinically significant active infection;","locations":[{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baoding NO.1 Central Hospital","city":"Baoding","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing GoBroad Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"BEIJING TONGREN HOSPITAL, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Bengbu Medical College","city":"Bengbu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer 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First Affiliated Hospital of Kunming Medical University","city":"Kunming","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Cancer Hospital","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Cancer Hospital","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Guangxi Medical University","city":"Nanning","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Qingdao University","city":"Qingdao","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruijin Hospital, Shanghai Jiaotong University School of 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treatment"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["shanghai-china","baoding-china","beijing-china","bengbu-china","changchun-china","changsha-china","chengdu-china","chongqing-china","fujian-china","fuzhou-china","guangzhou-china","guiyang-china","hangzhou-china","harbin-china","hefei-china","jinan-china","kunming-china","nanchang-china","nanjing-china","nanning-china","qingdao-china","shenyang-china","shenzhen-china","taiyuan-china","tangshan-china","tianjin-china","r-mqi-china","wenzhou-china","wuhan-china","xian-china","xiamen-china","xuzhou-china","zhengzhou-china"],"enrichment":{"headline":"Phase 3: testing HMPL-760 for Relapsed/Refractory Diffuse Large B-Cell Lymphoma","inPlainEnglish":"This is a Phase III randomly assigned, neither you nor the study doctors know who gets the real treatment, positive controlled study to measure the how well it works, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus dummy treatment (placebo) in combination with R-GemOx in patients with R/R DLBCL.","whoItsFor":["Ages 18 Years to any","Sign the ICF and be able to follow the requirements of study protocol;","how well you can do daily activities (ECOG score) score between 0 and 2;","Histopathologically confirmed diagnosis of DLBCL;","The investigator judges that the patient's current condition requires further treatment;","Patients should have at least one bi-dimensionally measurable lesion;","Expected survival is more than 12 weeks;"],"whoShouldSkip":["Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;","Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;","Organ insufficiency;","Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);","History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;","Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);","The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and"],"whatHappens":"If you join, the listed intervention(s) are HMPL-760, HMPL-760 Placebo, or R-GemOx. The registry lists allocation as randomized. This is a Phase III randomly assigned, neither you nor the study doctors know who gets the real treatment, positive controlled study to measure the how well it works, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus dummy treatment (placebo) in combination with R-GemOx in patients with R/R DLBCL.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 240 people at 51 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.148Z"},{"nctId":"NCT07412028","title":"Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With \"Classic\" Polycystic Ovary Syndrome (PCOS)","officialTitle":"Identification of Women With Severe Insulin Resistant Syndromes of Genetic Origin Among Patients With \"Classic\" Polycystic Ovary Syndrome (PCOS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+/- 5 years) and Body mass index (+/- 5kg/m2).","conditions":["Polycystic Ovary Syndrome","Familial Partial Lipodystrophy","LMNA (LaMin Nuclear A) Related Disorders"],"keywords":["Polycystic Ovary Syndrome","Familial Partial Lipodystrophy","LMNA related disorders"],"interventions":[{"type":"GENETIC","name":"Genetic analysis"},{"type":"OTHER","name":"Biological analysis"},{"type":"OTHER","name":"imaging test"},{"type":"OTHER","name":"Standard intervention"}],"enrollment":81,"startDate":"2026-07-21","completionDate":"2028-01","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged ≥ 18 years and \\< 45 years ;\n* Discontinuation of estrogen-progestin therapyfor at least 3 months ;\n* Signed informed consent ;\n* Social security affiliation.\n\nCase (n=25):\n\n\\- Patient with a lipodystrophic syndrome due to a known pathogenic variant of the LMNA gene.\n\nControl (n=50), :\n\n\\- patient consulting for polycystic ovary syndrome (PCOS according to the Rotterdam criteria) in day hospital matched on age +/-5 years and BMI+/-5 kg/m2.\n\nExclusion Criteria:\n\n* \\- Severe renal insufficiency (GFR \\< 30 ml/min) ;\n* Hepato-cellular insufficiency (TP \\< 50%) ;\n* Taking corticosteroids or antiretrovirals ;\n* Menopausal women ;\n* Taking estrogen-progestin therapy;\n* Diabetic patients on insulin : type 1 diabetes or pancreatectomised patients\n* Other known causes of hyperandrogenism (21-hydroxylase block, Cushing's syndrome, ovarian tumor).\n* Pregnant woman\n* Breastfeeding woman","locations":[{"facility":"Service Endocrinologie, Hôpital St Antoine","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sophie LAMOTHE, Doctor","phone":"0149282406","email":"sophie.lamothe@aphp.fr"},{"name":"Camille VATIER, Doctor","phone":"0149282406","email":"camille.vatier@aphp.fr"}],"primaryOutcomes":["Measure of Insulinemia rate during an orally induced hyperglycemia","Measure of C-peptide rate during an orally induced hyperglycemia","Measure of glycaemia rate during an orally induced hyperglycemia","Research of mutation of the LMNA (FPLD2) gene"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: Genetic analysis for Polycystic Ovary Syndrome","inPlainEnglish":"Diagnostic case-control study (1 case for 2 controls). Inclusion of patients with severe insulin resistance syndrome of genetic origin, then inclusion of controls: patients examined for PCOS in day hospital with matching age (+/- 5 years) and Body mass index (+/- 5kg/m2).","whoItsFor":["Ages 18 Years to 45 Years","Women only","Women aged ≥ 18 years and \\< 45 years ;","Discontinuation of estrogen-progestin therapyfor at least 3 months ;","Social security affiliation","\\- Patient with a lipodystrophic syndrome due to a known pathogenic variant of the LMNA gene","\\- patient consulting for polycystic ovary syndrome (PCOS according to the Rotterdam criteria) in day hospital matched on age +/-5 years and body-mass index (BMI)+/-5 kg/m2"],"whoShouldSkip":["\\- Severe renal insufficiency (GFR \\< 30 ml/min) ;","Hepato-cellular insufficiency (TP \\< 50%) ;","Taking corticosteroids or antiretrovirals ;","Taking estrogen-progestin therapy;","Diabetic patients on insulin : type 1 diabetes or pancreatectomised patients","Other known causes of hyperandrogenism (21-hydroxylase block, Cushing's syndrome, ovarian tumor)","Breastfeeding woman"],"whatHappens":"If you join, the listed intervention(s) are Genetic analysis, Biological analysis, or imaging test. The registry lists allocation as randomized. Diagnostic case-control study (1 case for 2 controls).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 81 people at Paris. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.794Z"},{"nctId":"NCT07412704","title":"A Study of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","officialTitle":"A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants With Refractory Rheumatoid Arthritis","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and the preliminary evidence of disease-modifying effect of BMS-986528 in participants with refractory, difficult-to-treat rheumatoid arthritis (RA).","conditions":["Arthritis, Rheumatoid"],"keywords":[],"interventions":[{"type":"DRUG","name":"BMS-986528"}],"enrollment":84,"startDate":"2026-10-06","completionDate":"2029-10-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n\\- Adult participants with rheumatoid arthritis (RA) who meet definition of difficult-to-treat.\n\nExclusion Criteria\n\n* Juvenile arthritis or onset of inflammatory arthritis before age 18.\n* Seronegative RA participants in whom polymyalgia rheumatica has not been ruled out.\n* Active fibromyalgia with pain symptoms or signs that would interfere with joint assessment.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 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Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yeungnam Univeristy Medical Center","city":"Gyeongsan-si","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inje University Haeundae Paik Hospital","city":"Pusan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyung Hee University Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kangbuk Samsung Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, Eunpyeong St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wonju Severance Christian Hospital","city":"Wŏnju","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changhua Christian Hospital","city":"Changhua","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tri-Service General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bakent University, Adana Clinic & Research Ctr.","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Antalya Egitim ve Arastırma Hastanesi","city":"Antalya","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ege Universitesi Hastanesi","city":"Bornova","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mustafa Kemal Universitesi","city":"Hatay","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bezmialem Vakf Üniversitesi","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kocaeli University Medical Faculty Hospital","city":"İzmit","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mersin University","city":"Mersin","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chernivtsi Regional Clinical Hospital","city":"Chernivtsi","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center of Limited Liability Company \"Medical Center \"Consilium Medical\"","city":"Kiev","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Edelweiss Medics","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Center Ok!Clinic+","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medbud Clinic","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Nonprofit Enterprise of Kyiv Region Council \"Kyiv Regional Clinical Hospital\"","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center of Family Medicine Plus","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Progastro Clinic","city":"Lviv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Transcarpathian Regional Hospital im.Andriya Novak","city":"Uzhhorod","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal Non-Commercial Enterprise \"Vinnytsia City Clinical Hospital #1\"","city":"Vinnytsia","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percentage of Participants Who Achieve Clinical Remission with Modified Mayo Score (mMS)","Percentage of Participants Who Achieve Clinical Remission with mMS Among Participants Who Achieved Clinical Response with LY4268989 at Week 10"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","scottsdale-arizona","anaheim-california","folsom-california","temple-city-california","victorville-california","colorado-springs-colorado","denver-colorado","lakewood-colorado","hamden-connecticut","daytona-beach-florida","kissimmee-florida","lakewood-rch-florida","orlando-florida","boise-idaho","idaho-falls-idaho","chicago-illinois","des-plaines-illinois","springfield-illinois","new-albany-indiana","louisville-kentucky","mandeville-louisiana","wyoming-michigan","rochester-minnesota","st-louis-missouri","las-vegas-nevada","moorestown-new-jersey","new-brunswick-new-jersey","stony-brook-new-york","greenville-north-carolina","wilmington-north-carolina","hilliard-ohio","springboro-ohio","westlake-ohio","portland-oregon","charleston-south-carolina","sioux-falls-south-dakota","jackson-tennessee","fort-worth-texas","garland-texas","houston-texas","mansfield-texas","san-antonio-texas","san-marcos-texas","tyler-texas","norfolk-virginia","seattle-washington","spokane-washington","tacoma-washington","buenos-aires-argentina","mendoza-argentina","quilmes-argentina","rosario-argentina","san-isidro-argentina","san-miguel-de-tucum-n-argentina","campinas-brazil","caxias-do-sul-brazil","curitiba-brazil","fortaleza-brazil","porto-alegre-brazil","salvador-brazil","santos-brazil","s-o-paulo-brazil","taja-brazil","greater-sudbury-canada","halifax-canada","london-canada","binzhou-china","changzhou-china","chengdu-china","chongqing-china","foshan-china","guangzhou-china","harbin-china","hefei-china","huizhou-china","kunming-china","liaocheng-china","meihekou-china","qingdao-china","shanghai-china","shaoguan-china","shenzhen-china","suzhou-china","taian-china","wuhan-china","zunyi-china","barranquilla-colombia","bogot-colombia","medell-n-colombia","bjelovar-croatia","osijek-croatia","split-croatia","zagreb-croatia","hradec-kr-lov-czechia","pardubice-czechia","prague-czechia","slan-czechia","sternberk-czechia","uhersk-hradi-t-czechia","vset-n-czechia","neuilly-sur-seine-france","pessac-france","pierre-b-nite-france","toulouse-france","athens-greece","heraklion-greece","thessaloniki-greece","budapest-hungary","gy-ngy-s-hungary","tatab-nya-hungary","allahab-d-india","belagavi-india","belgavi-india","hyderabad-india","jaipur-india","kochi-india","lucknow-india","mumbai-india","nagpur-india","new-delhi-india","noida-india","pune-india","ashdod-israel","ashkelon-israel","haifa-israel","jerusalem-israel","kfar-saba-israel","tsrifin-israel","milan-italy","rho-italy","rome-italy","rozzano-italy","asahikawa-japan","bunky-city-japan","fujiidera-japan","fukuoka-japan","hirosaki-japan","kagoshima-japan","kashiwa-japan","mitaka-japan","niigata-japan","nishinomiya-japan","okayama-japan","saitama-japan","sapporo-japan","suita-japan","tokyo-japan","riga-latvia","kaunas-lithuania","klaip-da-lithuania","chihuahua-city-mexico","ciudad-de-tijuana-mexico","guadalajara-mexico","irapuato-mexico","mexico-city-mexico","monterrey-mexico","quer-taro-mexico","chorz-w-poland","katowice-poland","kielce-poland","krakow-poland","lodz-poland","malbork-poland","nowy-targ-poland","poznan-poland","siedlce-poland","szczecin-poland","tychy-poland","warsaw-poland","zamo-poland","braga-portugal","lisbon-portugal","santa-maria-da-feira-portugal","san-juan-puerto-rico","belgrade-serbia","leskovac-serbia","sremska-mitrovica-serbia","zrenjanin-serbia","bratislava-slovakia","pre-ov-slovakia","rimavsk-sobota-slovakia","ahy-slovakia","bloemfontein-south-africa","cape-town-south-africa","johannesburg-south-africa","kempton-park-south-africa","busan-south-korea","daegu-south-korea","daejeon-south-korea","gwangju-south-korea","gyeongsan-si-south-korea","pusan-south-korea","seoul-south-korea","w-nju-south-korea","changhua-taiwan","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","bornova-turkey-t-rkiye","hatay-turkey-t-rkiye","istanbul-turkey-t-rkiye","i-zmit-turkey-t-rkiye","mersin-turkey-t-rkiye","chernivtsi-ukraine","kiev-ukraine","kyiv-ukraine","lviv-ukraine","uzhhorod-ukraine","vinnytsia-ukraine"],"enrichment":{"headline":"Phase 2: testing LY4268989 for Ulcerative Colitis (UC)","inPlainEnglish":"The main purpose of this study is to measure the safety and effectiveness of LY4268989 when compared to dummy treatment (placebo) in adult participants with moderately to severely active ulcerative colitis (UC). The study drug will be administered orally.","whoItsFor":["Ages 18 Years to 80 Years","Have had an established diagnosis of ulcerative colitis (UC) for ≥3 months prior to randomization, which includes endoscopic evidence of UC","Have moderately to severely active UC defined by a Modified Mayo Score (mMS) of 5 to 9 with an Endoscopic Score (ES)≥2 confirmed by central reader and rectal bleeding (RB)≥1","Have evidence of UC extending proximal to the rectum","Have documented evidence of having had a surveillance colonoscopy within 1 year, or according to local guidelines, to evaluate for polyps, dysplasia, or malignancy, prior to randomization, if the participant has a history of UC symptoms for more than 8 years","Must meet contraception requirements"],"whoShouldSkip":["Have a current diagnosis of","Inflammatory Bowel Disease (IBD unclassified) (formerly known as indeterminate colitis), or","primary sclerosing cholangitis","Have an inherited immunodeficiency syndrome or known monogenic cause of UC-like colonic inflammation","Have had or will need bowel resection or intestinal or intra-abdominal surgery","Have evidence of toxic megacolon, intra-abdominal abscess, or stricture or stenosis within small bowel or colon that cannot be traversed by a colonoscope or that are symptomatic","Have any prior or current evidence of cancer gastrointestinal (GI) tract, or specified lesions with increased risk of GI malignancies"],"whatHappens":"If you join, the listed intervention(s) are LY4268989, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to measure the safety and effectiveness of LY4268989 when compared to dummy treatment (placebo) in adult participants with moderately to severely active ulcerative colitis (UC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 1,431 people at 258 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.208Z"},{"nctId":"NCT07417436","title":"Effects of Graded Motor Imagery in Individuals With Foot/Ankle Osteoarthritis","officialTitle":"Effectiveness of Graded Motor Imagery Training in Individuals With Foot/Ankle Osteoarthritis: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alanya Alaaddin Keykubat University","sponsorClass":"OTHER","summary":"The aim of our study is to evaluate the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis.\n\nThe study population will consist of twenty-four individuals diagnosed with foot/ankle osteoarthritis who applied to the Orthopedics and Traumatology Department of Alanya Alaaddin Keykubat University Education and Research Hospital.\n\nIndividuals who volunteer to participate in the study will be invited to participate through face-to-face interviews. The inclusion and exclusion criteria are as follows:\n\nInclusion criteria:\n\n* Being 18 years of age or older\n* Having a diagnosis of foot/ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination\n* Experiencing pain in the ankle joint most days for at least three months\n* Agreeing to participate in randomly assigned treatment and follow-up measurements\n* Having a sufficient level of Turkish language comprehension\n* Having a Standardized Mini Mental Test score of at least 24 points\n\nExclusion criteria:\n\n* Previous arthrodesis or joint replacement surgery on the affected ankle\n* Physical therapy for ankle osteoarthritis within the last three months\n* Vision or hearing problems that would affect compliance with treatment.\n* Presence of a neuromuscular disease\n* History of intra-articular ankle injections within the last 3 months\n* Initiation of a new disease-specific pharmacological treatment during the study period During the study period, participants will receive one of the physical therapy programs. One group will only participate in the structured exercise program, while the other group will receive graded motor imagery training in addition to the exercise program.Both treatment groups will receive a total of 12 treatment sessions over 6 weeks.\n\nThe results of this study may help improve physiotherapy programs for individuals with similar health conditions.","conditions":["Ankle Osteoarthritis","Foot Osteoarthritis"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Exercise Program"},{"type":"BEHAVIORAL","name":"Exercise plus graded motor imagery"}],"enrollment":24,"startDate":"2026-03-10","completionDate":"2026-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Be 18 years of age or older,\n* Have a diagnosis of foot and/or ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination\n* Experience pain in the ankle joint most days for at least three months\n* Agree to participate in randomly assigned treatment and follow-up measurements\n* Have sufficient understanding of the Turkish language\n* Have a Standardized Mini Mental Test score of at least 24 points\n\nExclusion Criteria:\n\n* Previous arthrodesis or joint replacement surgery on the affected ankle,\n* Having received physical therapy for ankle osteoarthritis within the last three months\n* Presence of vision or hearing problems that may affect compliance with treatment.\n* Presence of a neuromuscular disease\n* History of intra-articular ankle injections within the last 3 months\n* Initiation of a new disease-specific pharmacological treatment during the study period","locations":[{"facility":"Alanya Alaaddin Keykubat University Training and Research Hospital","city":"Antalya","state":"Antalya","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alanya Alaaddin Keykubat University Training and Research Hospital","city":"Antalya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Özlem Nur Tok Yaman, PhD","phone":"+90-242-5106060","email":"ozlem.tok@alanya.edu.tr"}],"primaryOutcomes":["Socio-demographic assessment form","Pain Intensity Assessment","Pain Threshold Measurement","Gait Analysis","Foot Function Index","Laterality assessment"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["antalya-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Exercise Program for Ankle Osteoarthritis","inPlainEnglish":"The aim of our study is to measure the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis. The study population will consist of twenty-four individuals diagnosed with foot/ankle osteoarthritis who applied to the Orthopedics and Traumatology Department of Alanya Alaaddin Keykubat University Education and Research Hospital.","whoItsFor":["Ages 18 Years to any","Be 18 years of age or older,","Have a diagnosis of foot and/or ankle osteoarthritis confirmed by a specialist physician through clinical and/or radiological examination","Experience pain in the ankle joint most days for at least three months","Agree to participate in randomly assigned treatment and follow-up measurements","Have sufficient understanding of the Turkish language","Have a Standardized Mini Mental Test score of at least 24 points"],"whoShouldSkip":["Previous arthrodesis or joint replacement surgery on the affected ankle,","Having received physical therapy for ankle osteoarthritis within the last three months","Presence of vision or hearing problems that may affect compliance with treatment","Presence of a neuromuscular disease","History of intra-articular ankle injections within the last 3 months","Initiation of a new disease-specific pharmacological treatment during the study period"],"whatHappens":"If you join, the listed intervention(s) are Exercise Program, or Exercise plus graded motor imagery. The registry lists allocation as randomized. The aim of our study is to measure the effects of graded motor imagery training applied in addition to a structured exercise program in individuals with foot and/or ankle osteoarthritis.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.523Z"},{"nctId":"NCT07418034","title":"A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","officialTitle":"A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Maryland, Baltimore","sponsorClass":"OTHER","summary":"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive. However, the different treatments used for this cancer can cause significant side effects. Because outcomes are often favorable regardless of treatment type, reducing treatment-related side effects should be a priority when choosing care.\n\nStudies have reported that lowering radiation doses for some patients can reduce side effects while still effectively controlling the cancer.\n\nPatients with this type of head and neck cancer typically receive either surgery or radiation as their first treatment.\n\nFor patients who receive surgery first, radiation to the surgical area and nearby neck lymph nodes is often recommended afterward. In these patients, the study will test whether lowering the radiation dose to low-risk lymph nodes on the side of the neck opposite the tumor can reduce side effects while still effectively controlling the cancer (Method A).\n\nFor patients who receive radiation as their first treatment, the study will test one or both of two radiation approaches aimed at reducing both short-term and long-term side effects. These approaches include reduced lymph node radiation (Method A, described above) and a tumor dose reduction approach (Method B), which lowers the radiation dose delivered directly to the tumor.\n\nInformation such as tumor size, the number of cancerous or suspicious lymph nodes, and risk factors like smoking history will be used to determine which patients may be eligible for reduced lymph node radiation (Method A), reduced tumor radiation (Method B), or both. Patients who may qualify for tumor dose reduction (Method B), either alone or combined with Method A, will need an additional blood test called a circulating tumor DNA (ctDNA) test to determine eligibility.\n\nThe ctDNA test measures small amounts of tumor-related DNA in the blood, which are often elevated at the time of diagnosis. Studies have shown that cancer is more likely to return when ctDNA levels remain positive after treatment. This study will evaluate whether ctDNA levels measured before and during treatment can help identify patients who can safely receive lower radiation doses to the tumor (Method B).\n\nOverall, this study aims to safely evaluate two radiation de-escalation approaches in order to lessen short- and long-term side effects while maintaining excellent cancer control.","conditions":["Head and Neck Cancer","Head and Neck Squamous Cell Cancer","Head and Neck Squamous Cell Carcinoma","Oropharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma (OPSCC)","Oropharyngeal Human Papillomavirus-Positive Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Oropharyngeal Squamous Cell Carcinoma (SCC)","Oropharyngeal Squamous Cell Carcinoma (OPSCCA)","Oropharyngeal Cancer","Oropharyngeal Squamous Cell Cancer","HPV Positive Oropharyngeal Squamous Cell Carcinoma","HPV (Human Papillomavirus)-Associated Carcinoma","HPV 16 Positive Oropharyngeal Tumors (OPC)"],"keywords":["Transoral Robotic Surgery (TORS)","Head and Neck Cancer","Oropharynx Cancer","HPV p16 Oropharynx Cancer","Proton Therapy","Photon Therapy","Radiation Therapy","ctDNA","P16 positive"],"interventions":[{"type":"RADIATION","name":"Dose de-escalation to contralateral neck."},{"type":"RADIATION","name":"Dose de-escalation to gross disease to contralateral neck"},{"type":"RADIATION","name":"Dose de-escalation to gross disease"},{"type":"DIAGNOSTIC_TEST","name":"Circulating Tumor DNA test (ctDNA test)"}],"enrollment":132,"startDate":"2026-10-19","completionDate":"2031-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"4.1 Step 1 Registration 4.1.1 Step 1 Inclusion\n\n(Y) 1. Is there pathologically (histologically or cytologically) proven diagnosis of squamous cell carcinoma (including the histological variants papillary squamous cell carcinoma and basaloid squamous cell carcinoma) of the oropharynx or squamous cell carcinoma unknown primary? Note: specimen from cervical lymph nodes with a well-defined primary site documented clinically or radiologically is acceptable; in patients with carcinoma of unknown primary this will be sufficient for pathologic confirmation without a clinically or radiographically defined primary site.\n\n(Y) 2. Is the patient ≥ 18 years of age?\n\n(Y) 3. Did the patient provide study specific informed consent prior to study entry, including consent for mandatory submission of tissue for required p16 review?\n\n(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):\n\nTORS candidate patients must be:\n\n• cT0-4 and N0, N1, N3\n\nNon-TORS candidate patients must be either:\n\n* cT1-4 N0, N1, N3\n* cT1-3 N2 with \\< 10 pack years\n\n4.1.2 Step 1 Exclusion\n\n(N) 1. Patient who are clinical N2 and have ≥10 pack years smoking history\n\n(N) 2. Patients who are clinical T4N2\n\n(N) 3. Patients with distant metastasis (M1)\n\n4.2 Step 2 Registration 4.2.1 Step 2 inclusion\n\n(Y) 1. Does the patient have pathologically (histologically or cytologically) proven P16+ status?\n\n(Y) 2. Does the patient have appropriate imaging (PET/CT preferred, CT neck with IV contrast and CT chest without contrast as recommended alternative to PET/CT) completed within 90 days of enrollment?\n\n(Y) 3. Does the patient have clinical or pathological M0 staging? (Y) 4. Patients who have undergone TORS must have pathological stage pT1-4 N0, N1 or N3. TORS patients found to be clinical N2 post TORS or have contralteral neck dissection and positive nodes will be excluded.\n\n(Y) 5. Is the patient a candidate for bilateral radiation based on evaluation by ENT, Rad Onc, or Med Onc and review at multi-disciplinary tumor board?\n\n(Y) 6. Non-TORS patients who are cT1-3 N0, N1, N2 and have \\<10 PY must have completed a ctDNA evaluation prior to Step 2 enrollment.\n\n(Y) 7. Non-TORS patients who are cT1-3 N2 must have a positive ctDNA result prior to Step 2 enrollment.\n\n(Y) 8. Was a general history and physical examination performed by a radiation oncologist, medical oncologist, or head and neck surgeon within 60 days prior to registration?\n\n(Y) 9. Was the patient's Zubrod Performance Status 0-1 within 30 days prior to registration?\n\n(Y) 10. If a woman of child-bearing potential or sexually active male, is the patient willing to use effective contraception throughout their participation in the treatment phase of the study and at least 180 days following the last study treatment.\n\n4.2.2 Step 2 Exclusion\n\n(N) 1. Does the patient have cancer considered to be from an oral cavity site (oral tongue, floor mouth, alveolar ridge, buccal or lip), nasopharynx, hypopharynx, or larynx?\n\n(N) 2. Does the patient have distant metastasis?\n\n(N) 3. Does the patient have prior invasive malignancy (except non-melanomatous skin cancer and low/intermediate risk prostate cancer) unless disease free for a minimum of 3 years?\n\n(N) 4. Did the patient have prior systemic chemotherapy for the study cancer (prior chemotherapy for a different cancer is allowable)?\n\n(N) 5. Did the patient have prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields?\n\n(N) 6. Did the patient have prior cancer-related surgeries of curative intent of the head and neck excluding superficial removal of cutaneous skin malignancies?\n\n(N) 7. Does the patient have any co-morbid condition or concern that may interfere with follow up per experimental arm?\n\n(N) 8. Does the patient have an active drug or alcohol dependency that in the opinion of the investigator would limit compliance with study requirements?\n\n(N) 9. Is the patient pregnant or nursing (an exception will be made for nursing patients that are not receiving chemotherapy)?","locations":[{"facility":"Maryland Proton Treatment Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Greenebaum Cancer Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Maryland Radiation Oncology","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baltimore Washington Medical Center- Tate Cancer Center","city":"Glen Burnie","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jason K Molitoris","phone":"410-328-6080","email":"jmolitoris@umm.edu"},{"name":"Kelly Kitzmiller","phone":"410-369-5264","email":"kelly.kitzmiller@umm.edu"}],"primaryOutcomes":["Freedom From Regional Failures (FFRF)","Freedom From Local Recurrence (FFLR)"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["baltimore-maryland","columbia-maryland","glen-burnie-maryland"],"enrichment":{"headline":"Phase 2: Dose de-escalation to contralateral neck. for Head and Neck Cancer","inPlainEnglish":"Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes. Patients' treatment responses depend more on their individual cancer characteristics and personal risk factors than on the specific type of treatment they receive.","whoItsFor":["Ages 18 Years to any","1 Step 1 Registration 4.1.1 Step 1 Inclusion","(Y) 2. Is the patient ≥ 18 years of age?","(Y) 4. Clinical TNM staging criteria by cohort (AJCC 8th edition):","TORS candidate patients must be:","cT0-4 and N0, N1, N3","Non-TORS candidate patients must be either:","cT1-3 N2 with \\< 10 pack years"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Dose de-escalation to contralateral neck., Dose de-escalation to gross disease to contralateral neck, or Dose de-escalation to gross disease. The registry lists allocation as na. Patients with human papillomavirus (HPV)-related oropharyngeal cancer generally have very good outcomes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 132 people at 4 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.022Z"},{"nctId":"NCT07418177","title":"Study in Human iPSCs-derived RPE Cells Transplantation for Advanced (Late-stage) AMD","officialTitle":"Study in Human iPSCs-derived Retinal Pigment Epithelium Cells Transplantation for Advanced (Late-stage) Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"The First Affiliated Hospital with Nanjing Medical University","sponsorClass":"OTHER","summary":"Phase I Study of the Safety and Preliminary Efficacy of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial Cells (hiPSC-RPEs) Subretinal Transplantation in Adanced (Late-Stage) Age-Related Macular Degeneration(AMD) Patients.","conditions":["AMD - Age-Related Macular Degeneration"],"keywords":["Age-Related Macular Degeneration","AMD","hiPSC-RPEs","geographic atrophy","wet AMD"],"interventions":[{"type":"BIOLOGICAL","name":"hiPSC-RPEs"}],"enrollment":12,"startDate":"2025-10-14","completionDate":"2028-12-31","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* (1)Age ≥50 years and ≤85 years, regardless of gender.\n* (2)Patients with atrophic AMD in the macular area (geographic atrophy \\>250μm, involving the foveal center); or inactive neovascular AMD patients who have undergone treatment for wet AMD or have naturally converted to non-exudative AMD (referring to patients with fibrovascular scar formation, who are unresponsive to anti-VEGF treatment, and have no macular edema on OCT and/or no fluorescein leakage on FFA), with a scar diameter not exceeding 6 PD.\n* (3)Best-corrected visual acuity (BCVA) of the study eye ≥5 letters and ≤34 letters (using the ETDRS visual acuity chart).\n* (4)If both eyes meet the criteria, the more severely affected eye will be selected; if the severity is the same in both eyes, the right eye will be designated as the study eye.\n* (5)The patient or their legal representative has signed a written informed consent form.\n\nExclusion Criteria:\n\n* Ocular Diseases:\n* (1)Vitreous hemorrhage in the study eye within 2 months prior to screening.\n* (2)Presence of a scar or fibrosis involving the fovea in the study eye, or a peripheral scar area greater than 6 PD, indicating severe irreversible visual loss.\n* (3)Presence of pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage causing visual loss, rhegmatogenous retinal detachment, macular hole, or active choroidal neovascularization in the study eye.\n* (4)Afferent pupillary defect (APD) in the study eye.\n* (5)Significant media opacity in the study eye (excluding lens opacities) that may interfere with visual function assessment or fundus examination.\n* (6)Acute infectious inflammation in either eye during the screening period.\n* (7)Patients with intraocular pressure higher than 25 mmHg despite medical treatment.\n* (8)Monocular blind patients.\n\nOcular Treatments:\n\n* (9)The study eye has undergone focal/grid laser photocoagulation within 3 months prior to screening.\n* (10)The study eye has undergone any intraocular surgery within 3 months prior to screening.\n* (11) Any eye has received anti-angiogenic therapy (including any anti-VEGF agents, e.g., Aflibercept \\[Eylea®\\], Ranibizumab \\[Lucentis®\\], Bevacizumab \\[Avastin®\\]) within 1 month prior to screening; or has undergone cataract surgery within 1 month prior to screening with unstable postoperative ocular conditions.\n\nSystemic Diseases, Treatments, and Other Conditions:\n\n* (12)Patients with an allergic reaction or history of allergy to sodium fluorescein and indocyanine green, a history of allergy to protein products used for treatment or diagnosis, and patients with allergies to two or more drugs and/or non-drug factors, or those currently suffering from allergic diseases.\n* (13)Patients with uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L or 2-hour postprandial blood glucose ≥11.1 mmol/L).\n* (14)Patients with a history of surgical procedures within 1 month prior to screening, or those with unhealed wounds, ulcers, fractures, etc.\n* (15)Patients with uncontrolled hypertension (defined as a single measurement of systolic blood pressure \\>180 mmHg, two consecutive measurements of systolic blood pressure \\>160 mmHg, or diastolic blood pressure \\>100 mmHg despite optimal treatment).\n* (16)Patients with a history of myocardial infarction within 6 months prior to enrollment.\n* (17)Patients with active disseminated intravascular coagulation or a significant tendency to bleed; patients who have used anticoagulant or antiplatelet aggregation drugs within 14 days prior to screening, except for aspirin/nonsteroidal anti-inflammatory drugs.\n* (18) Presence of any uncontrolled systemic clinical conditions, such as interstitial pneumonia, severe psychiatric, neurological, cardiovascular, or respiratory diseases, malignant tumors, Parkinson's disease, Alzheimer's disease, or other severe systemic disorders.\n* (19)Women of childbearing age with a positive pregnancy test during the screening period. Women who wish to breastfeed during the study period, and all patients of childbearing age (male and female) who do not agree to take effective contraceptive measures (such as intrauterine devices, oral contraceptives, or condoms) throughout the study period and for 30 days after the end of the visit period.\n* (20)Patients who have participated in or are currently participating in other clinical studies within 30 days prior to screening.\n* (21)Hemoglobin \\<100 g/L, platelets ≤100×10\\^9/L, neutrophil count \\<1.0×10\\^9/L, ALT/AST \\>1.5×upper limit of normal (ULN), creatinine \\>1.3 mg/dL.\n* (22)Subjects with any clinically significant finding in virological tests (HIV, HBV, HCV and TPPA).\n* (23)Patients deemed unsuitable for inclusion by the investigator, or other medical conditions that limit the subject's compliance, safety, or affect the results of the trial results.","locations":[{"facility":"The First Affiliated Hospital with Nanjing Medical University","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Songtao Yuan, M.D.","phone":"+86159-5108-8899","email":"songtaoyuan@njmu.edu.cn"}],"primaryOutcomes":["Incidence and Severity of Treatment-Related Adverse Events"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["nanjing-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing hiPSC-RPEs for AMD - Age-Related Macular Degeneration","inPlainEnglish":"Phase I Study of the Safety and Preliminary how well it works of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial Cells (hiPSC-RPEs) Subretinal Transplantation in Adanced (Late-Stage) Age-Related Macular Degeneration(AMD) Patients.","whoItsFor":["Ages 50 Years to 85 Years","(1)Age ≥50 years and ≤85 years, regardless of gender","(3)Best-corrected visual acuity (BCVA) of the study eye ≥5 letters and ≤34 letters (using the ETDRS visual acuity chart)","(4)If both eyes meet the criteria, the more severely affected eye will be selected; if the severity is the same in both eyes, the right eye will be designated as the study eye"],"whoShouldSkip":["(1)Vitreous hemorrhage in the study eye within 2 months prior to screening","(2)Presence of a scar or fibrosis involving the fovea in the study eye, or a peripheral scar area greater than 6 PD, indicating severe irreversible visual loss","(3)Presence of pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage causing visual loss, rhegmatogenous retinal detachment, macular hole, or active choroidal neovascularization in the study eye","(4)Afferent pupillary defect (APD) in the study eye","(5)Significant media opacity in the study eye (excluding lens opacities) that may interfere with visual function assessment or fundus examination","(6)Acute infectious inflammation in either eye during the screening period","(7)Patients with intraocular pressure higher than 25 mmHg despite medical treatment"],"whatHappens":"If you join, the listed intervention(s) are hiPSC-RPEs. The registry lists allocation as na. Phase I Study of the Safety and Preliminary how well it works of Human induced pluripotent stem cells-derived Retinal Pigment Epithelial Cells (hiPSC-RPEs) Subretinal Transplantation in Adanced (Late-Stage) Age-Related Macular Degeneration(AMD) Patients.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 12 people at Nanjing. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.152Z"},{"nctId":"NCT07419295","title":"A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) to Treat Urothelial Cancer (MK-2870-031)","officialTitle":"A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator's Choice of Non-platinum Chemotherapy in Participants With Pretreated Locally Advanced/Metastatic Urothelial Carcinoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.\n\nResearchers want to know if giving sacituzumab tirumotecan (sac-TMT), the trial medicine, can treat locally advanced or metastatic UC that got worse after certain treatments. The goal of this trial is to learn if people who receive sac-TMT live longer than those who receive certain non-platinum chemotherapies.","conditions":["Bladder Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Sacituzumab tirumotecan"},{"type":"DRUG","name":"Vinflunine"},{"type":"DRUG","name":"Docetaxel"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Rescue medications for sacituzumab tirumotecan"},{"type":"DRUG","name":"Rescue medications for chemotherapy"}],"enrollment":590,"startDate":"2026-04-23","completionDate":"2029-07-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment\n* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator\n* Has received treatment with anti-programmed cell death \\[ligand\\] 1 (anti-PD-\\[L\\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)\n* Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry\n* Has received a maximum of 2 prior lines of therapy\n* Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\n* Is eligible to receive at least one of the control arm nonplatinum chemotherapy options (paclitaxel, docetaxel, or vinflunine)\n* Is able to provide archival tumor tissue sample or newly obtained biopsy of a tumor lesion not previously irradiated\n* If human immunodeficiency virus (HIV) positive, has well-controlled HIV on antiretroviral therapy (ART)\n* If hepatitis B surface antigen (HBsAg) positive, has received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and has undetectable HBV viral load\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load\n* Has adequate organ function\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) and has not recovered to grade ≤ 1 or baseline from adverse event (AE) associated with anticancer therapy\n* Has received prior therapy with trophoblast cell-surface antigen 2 (TROP2)-targeted antibody drug conjugate (ADC)\n* Has received prior therapy with a topoisomerase 1 inhibitor-containing ADC\n* Has completed prior external radiotherapy within 6 weeks or stereotactic radiotherapy within 4 weeks of start of study intervention, or has radiation related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received prior chemotherapy for urothelial cancer with any of the study therapies in the control arm (paclitaxel, docetaxel, and vinflunine)\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a current or past history of central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has an active infection requiring systemic therapy other than those permitted per protocol\n* Has a history of stem cell/solid organ transplant\n* Has not adequately recovered from major surgery, or has ongoing surgical complications","locations":[{"facility":"Hoag Memorial Hospital Presbyterian ( Site 0814)","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sibley Memorial Hospital ( Site 0849)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital ( Site 0824)","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University ( Site 0843)","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute ( Site 0783)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Munson Medical Center ( Site 0812)","city":"Traverse City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Morristown Memorial Hospital ( Site 0795)","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center ( Site 0832)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WakeMed Raleigh Campus ( Site 0811)","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TriHealth Cancer Institute-Good Samaritan Hospital ( Site 0822)","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Cleveland Case Medical Center ( Site 0834)","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic - Ohio ( Site 0793)","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fox Chase Cancer Center ( Site 0830)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The West Clinic, P.C. ( Site 0791)","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thompson Cancer Survival Center ( Site 0803)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 0831)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah, Huntsman Cancer Institute ( Site 0810)","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Oncology Associates (VOA) ( Site 8002)","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Research Center ( Site 0787)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires ( Site 0004)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asociacion de Beneficencia Hospital Sirio Libanes ( Site 0003)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0002)","city":"Ciudad Autónoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncologia de Rosario ( Site 0005)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University ( Site 0031)","city":"Macquarie","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Hospital Brisbane ( Site 0032)","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc ( Site 0062)","city":"Brussels","state":"Bruxelles-Capitale, Region de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Maria Middelares ( Site 0063)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent ( Site 0064)","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHC Montlegia Clinic ( Site 0061)","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICTRIALS Pesquisa e Desenvolvimento ( Site 0107)","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Moinhos de Vento ( Site 0102)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0110)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Alemao Oswaldo Cruz ( Site 0101)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lakeridge Health ( Site 0122)","city":"Oshawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0123)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0121)","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital ( Site 0184)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chonqing Medical University ( Site 0197)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center ( Site 0183)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center ( Site 0188)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhujiang Hospital of Southern Medical University ( Site 0205)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0189)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fifth Affiliated Hospital of Sun Yat-Sen University ( Site 0900)","city":"Zhuhai","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0198)","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University ( Site 0916)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital ( Site 0182)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Cancer Hospital ( Site 0917)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Cancer Hospital ( Site 0192)","city":"Nanchang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center ( Site 0181)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital Fudan University ( Site 0907)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University ( Site 0185)","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Tianjin Medical University ( Site 0910)","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jiaxing ( Site 0901)","city":"Jiaxing","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Ningbo University ( Site 0193)","city":"Ningbo","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0186)","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Wenzhou Medical University ( Site 0194)","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Brest ( Site 0272)","city":"Brest","state":"Finistere","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0280)","city":"Rennes","state":"Ille-et-Vilaine","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0304)","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Oncology Hospital of Kifisia \"Agioi Anargyroi\" ( Site 0335)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"METROPOLITAN GENERAL HOSPITAL-ONCOLOGIC CLINICAL TRIALS AND RESEARCH CLINIC ( Site 0332)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital ''Attikon'' - General Hospital of West Attica \"H AGIA VARVARA\" ( Site 0333)","city":"Chaïdári","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Athens Medical Center ( Site 0336)","city":"Marousi","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"European Interbalkan Medical Center ( Site 0331)","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0362)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center ( Site 0366)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 0364)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0361)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yitzhak Shamir Medical Center. ( Site 0367)","city":"Tsrifin","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas ( Site 0398)","city":"Rozzano","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 0399)","city":"Naples","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera S. Luigi Gonzaga ( Site 0391)","city":"Orbassano","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Ricerche Cliniche di Verona ( Site 0393)","city":"Verona","state":"Veneto","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Donato. Azienda Sanitaria Toscana Sud Est ( Site 0392)","city":"Arezzo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliera Metropolitana ( Site 0394)","city":"Genova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 0396)","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Generale Provinciale Macerata ( Site 0395)","city":"Province of Macerata","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0397)","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital ( Site 0429)","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hirosaki University Hospital ( Site 0435)","city":"Hirosaki","state":"Aomori","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ehime University Hospital ( Site 0430)","city":"Tōon","state":"Ehime","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hokkaido University Hospital ( Site 0436)","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe University Hospital ( Site 0431)","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tsukuba Hospital ( Site 0432)","city":"Tsukuba","state":"Ibaraki","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kagawa University Hospital ( Site 0424)","city":"Kita-gun","state":"Kagawa-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Marianna University Hospital ( Site 0422)","city":"Kawasaki","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kitasato University Hospital ( Site 0425)","city":"Sagamihara","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nara Medical University Hospital ( Site 0423)","city":"Kashihara","state":"Nara","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Rosai Hospital ( Site 0428)","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital ( Site 0421)","city":"Bunkyo","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Institute Hospital of JFCR ( Site 0426)","city":"Koto","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyushu University Hospital ( Site 0434)","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gifu University Hospital ( Site 0427)","city":"Gifu","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyoto University Hospital ( Site 0433)","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboudumc ( Site 0487)","city":"Nijmegen","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maastricht UMC+ ( Site 0483)","city":"Maastricht","state":"Limburg","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0482)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elisabeth-TweeSteden Ziekenhuis ( Site 0489)","city":"Tilburg","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Isala, locatie Zwolle ( Site 0486)","city":"Zwolle","state":"Overijssel","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Medisch Centrum ( Site 0481)","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Antonius Ziekenhuis, locatie Utrecht ( Site 0488)","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. de Badalona Germans Trias I Pujol ( Site 0603)","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marques de Valdecilla ( Site 0605)","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Insular de Gran Canaria ( Site 0604)","city":"Las Palmas de Gran Canaria","state":"Las Palmas","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramon y Cajal ( Site 0606)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d Hebron ( Site 0607)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico San Carlos ( Site 0608)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 0602)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Virgen del Rocio ( Site 0601)","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Laenssjukhuset Ryhov ( Site 0632)","city":"Jönköping","state":"Jönköping County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karolinska Universitetssjukhuset Solna ( Site 0631)","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cambridge University Hospitals NHS Foundation Trust ( Site 0756)","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital ( Site 0751)","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["newport-beach-california","washington-d-c-district-of-columbia","atlanta-georgia","baltimore-maryland","boston-massachusetts","traverse-city-michigan","morristown-new-jersey","new-york-new-york","raleigh-north-carolina","cincinnati-ohio","cleveland-ohio","philadelphia-pennsylvania","germantown-tennessee","knoxville-tennessee","nashville-tennessee","salt-lake-city-utah","norfolk-virginia","seattle-washington","ciudad-autonoma-de-buenos-aires-argentina","ciudad-aut-noma-de-buenos-aires-argentina","rosario-argentina","macquarie-australia","south-brisbane-australia","brussels-belgium","ghent-belgium","li-ge-belgium","curitiba-brazil","porto-alegre-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","oshawa-canada","toronto-canada","qu-bec-canada","beijing-china","chongqing-china","guangzhou-china","zhuhai-china","wuhan-china","changsha-china","nanjing-china","nanchang-china","shanghai-china","chengdu-china","tianjin-china","jiaxing-china","ningbo-china","wenzhou-china","brest-france","rennes-france","berlin-germany","athens-greece","cha-d-ri-greece","marousi-greece","thessaloniki-greece","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tsrifin-israel","rozzano-italy","naples-italy","orbassano-italy","verona-italy","arezzo-italy","genova-italy","milan-italy","province-of-macerata-italy","roma-italy","nagoya-japan","hirosaki-japan","t-on-japan","sapporo-japan","kobe-japan","tsukuba-japan","kita-gun-japan","kawasaki-japan","sagamihara-japan","kashihara-japan","sakai-japan","bunkyo-japan","koto-japan","fukuoka-japan","gifu-japan","kyoto-japan","nijmegen-netherlands","maastricht-netherlands","amsterdam-netherlands","tilburg-netherlands","zwolle-netherlands","rotterdam-netherlands","utrecht-netherlands","badalona-spain","santander-spain","las-palmas-de-gran-canaria-spain","madrid-spain","barcelona-spain","seville-spain","j-nk-ping-sweden","stockholm-sweden","cambridge-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Sacituzumab tirumotecan for Bladder Cancer","inPlainEnglish":"Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC). Current treatments for locally advanced or metastatic UC include chemotherapy, immunotherapy, and targeted therapy.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has histologically documented locally advanced/metastatic urothelial cancer. Locally advanced disease must not be amenable to resection or radiation with curative intent per investigator assessment","Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the investigator","Has received treatment with anti-programmed cell death \\[ligand\\] 1 (anti-PD-\\[L\\]1) therapy, platinum-based chemotherapy, and enfortumab vedotin (EV)","Prior therapy with disitamab vedotin (DV) is allowed but will not meet the requirement for prior treatment with EV, except in China, where participants may have received DV instead of EV before study entry","Has received a maximum of 2 prior lines of therapy","Has experienced radiographic disease progression on or after the immediate prior line of therapy before study entry"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, Vinflunine, or Docetaxel. The registry lists allocation as randomized. Researchers are looking for new ways to treat locally advanced or metastatic urothelial cancer (UC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 590 people at 113 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.285Z"},{"nctId":"NCT07419425","title":"My Path to Quit Tobacco","officialTitle":"Comparing Three Multicomponent Interventions to Help Adults Quit Smoking","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline. This study compares the relative effectiveness of three different treatments (Standard, Intensive, and Intensive Incentivized) on long-term smoking cessation (biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day) among Black adults who smoke and want to quit.","conditions":["Smoking Cessation"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nicotine patch"},{"type":"OTHER","name":"Quitline Counseling Phone Calls"},{"type":"OTHER","name":"Counseling Sessions"},{"type":"OTHER","name":"Pathways to Freedom"},{"type":"OTHER","name":"Monetary Incentive"}],"enrollment":1550,"startDate":"2026-07-06","completionDate":"2030-01","sex":"ALL","minAge":"21 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* self-identify as Black\n* smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)\n* motivated to quit smoking\n* willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment.\n\nExclusion Criteria:\n\n* currently taking bupropion for non-smoking cessation reasons","locations":[{"facility":"Arizona State University","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center Research Institute, Inc","city":"Kansas City","state":"Kansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University","city":"Richmond","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UW School of Medicine and Public Health","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Megan Piper, PhD","phone":"608-265-5472","email":"mep@ctri.wisc.edu"}],"primaryOutcomes":["Biochemically confirmed abstinence from combusted tobacco at 26-weeks post-target quit day"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","indianapolis-indiana","kansas-city-kansas","richmond-virginia","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 4: testing Nicotine patch for Smoking Cessation","inPlainEnglish":"The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults. The goal of this research proposal is to determine whether more intensive, culturally specific, evidence-based interventions are more effective at promoting long-term cessation and other key patient-centered outcomes compared to the usual evidence-based standard of care: services provided by a state-run quitline.","whoItsFor":["Ages 21 Years to any","self-identify as Black","smoke cigarettes (greater than or equal to 1 cigarette on greater than or equal to 4 days/week)","motivated to quit smoking","willing to discontinue any non-study smoking cessation pharmacotherapy use during study treatment"],"whoShouldSkip":["currently taking bupropion for non-smoking cessation reasons"],"whatHappens":"If you join, the listed intervention(s) are Nicotine patch, Quitline Counseling Phone Calls, or Counseling Sessions. The registry lists allocation as randomized. The overarching goal of this program of research is to reduce smoking-related health disparities by increasing smoking cessation among Black adults.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,550 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.353Z"},{"nctId":"NCT07419438","title":"Supraglottic Airway for Resuscitation in Preemies","officialTitle":"Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth.\n\nThe main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0/7 to 33 6/7 weeks' gestation premature infants?\n\nParticipants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.","conditions":["Respiratory Failure","Premature Neonates","Delivery Room Resuscitation","Positive Pressure Ventilation","Neonatal Resuscitation","Supraglottic Airway","Laryngeal Mask","Laryngeal Mask Airways"],"keywords":["Respiratory failure","Premature neonates","Delivery Room Resuscitation","Positive pressure ventilation","Neonatal resuscitation","Supraglottic Airway","laryngeal mask","Laryngeal Mask Airways"],"interventions":[{"type":"OTHER","name":"Supraglottic Airway"}],"enrollment":20,"startDate":"2026-03-13","completionDate":"2027-02","sex":"ALL","minAge":"0 Days","maxAge":"1 Day","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Gestational age 29 0/7 to 33 6/7 weeks at birth\n* Estimated fetal weight \\>/= 1000 grams at birth\n* Clinical decision to initiate PPV\n* Parental informed consent\n\nExclusion Criteria:\n\n* Major anomalies or aneuploidy\n* Palliative care planned or considered\n* Not resuscitated in the infant resuscitation room","locations":[{"facility":"Hospital of the University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sura Lee","phone":"215-873-9339","email":"sura.lee@pennmedicine.upenn.edu"}],"primaryOutcomes":["Feasibility of Supraglottic Airway as Primary Ventilation Interface"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Supraglottic Airway for Respiratory Failure","inPlainEnglish":"The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth.","whoItsFor":["Ages 0 Days to 1 Day","Gestational age 29 0/7 to 33 6/7 weeks at birth","Estimated fetal weight \\>/= 1000 grams at birth","Clinical decision to initiate PPV"],"whoShouldSkip":["Major anomalies or aneuploidy","Palliative care planned or considered","Not resuscitated in the infant resuscitation room"],"whatHappens":"If you join, the listed intervention(s) are Supraglottic Airway. The registry lists allocation as na. The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Philadelphia. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.786Z"},{"nctId":"NCT07420114","title":"Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery","officialTitle":"Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery: A Randomized Controlled Trial","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Chicago","sponsorClass":"OTHER","summary":"Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients.\n\nPrevious scholarship has demonstrated that telemedicine can be a safe alternative to face-to-face postoperative visits for surgical patients, streamlining recovery with no significant delays in the diagnosis of surgical complications. As healthcare systems continue to emphasize value-based care, it is important to assess whether virtual postoperative visits effectively meet patient needs while optimizing resource utilization.\n\nPatient-reported outcomes and satisfaction surveys can help identify potential gaps in care and ensure that telehealth is implemented in a way to maximize both efficiency and quality. Our primary objective is to determine whether patient satisfaction with postoperative telehealth follow-up is non-inferior to in-person clinic visits.","conditions":["to Determine Whether Patient Satisfaction With Postoperative Telehealth Follow-up is Non-inferior to In-person Clinic Visits"],"keywords":["telehealth","minimally invasive gynecologic surgery","hysterectomy","myomectomy","excision of endometriosis","laparoscopic surgeries","robotic surgeries","adnexal surgery"],"interventions":[],"enrollment":100,"startDate":"2026-07-31","completionDate":"2026-10","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant has provided written informed consent.\n2. Women over the age of 18.\n3. Ability for patients to complete telehealth visits (i.e. working telephone or internet access) and speak and understand English.\n4. Laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, and hysterectomy.\n5. Undergoing minimally invasive gynecologic surgeries with complex pelvic surgeons (AAGL fellowship-trained).\n\nExclusion Criteria:\n\n1. Conversion to open surgery.\n2. Malignancy noted intraoperatively or on final pathology evaluation.\n3. Surgeon or patient preference for in person clinic follow up.\n4. Pregnancy - pregnancy tests will be completed as part of routine preoperative care on the day of surgery","locations":[{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UChicago Medicine Advent Hinsdale","city":"Hinsdale","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Josef Jackson, MD","phone":"773-834-0598","email":"josef.jackson@uchicagomedicine.org"},{"name":"Sumeyra Agambayev, MS","phone":"","email":"sumeyra.agambayev@bsd.uchicago.edu"}],"primaryOutcomes":["Patient satisfaction with surgery and postoperative visits","Patient satisfaction with virtual care delivery"],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["chicago-illinois","hinsdale-illinois"],"enrichment":{"headline":"Outpatient Visits Versus Telehealth for Postoperative Care After Minimally Invasive Gynecologic Surgery","inPlainEnglish":"Telehealth, or telemedicine, utilizes technology to deliver clinical care remotely, either in real time or asynchronously, between clinician and patient. Telemedicine has been successfully implemented to increase healthcare delivery for patients in rural areas with otherwise long travel times, and studies have also determined that telemedicine can increase patient satisfaction scores while simultaneously decreasing direct and indirect costs for patients.","whoItsFor":["Ages 18 Years to any","Women only","Women over the age of 18","Laparoscopic or robotic surgeries including: excision of endometriosis, adnexal surgery with oophorectomy or cystectomy, myomectomy, and hysterectomy","Undergoing minimally invasive gynecologic surgeries with complex pelvic surgeons (AAGL fellowship-trained)"],"whoShouldSkip":["Conversion to open surgery","Malignancy noted intraoperatively or on final pathology evaluation","Surgeon or patient preference for in person clinic follow up","Pregnancy - pregnancy tests will be completed as part of routine preoperative care on the day of surgery"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.118Z"},{"nctId":"NCT07423117","title":"A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy","officialTitle":"A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"IntoCell, Inc","sponsorClass":"INDUSTRY","summary":"The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).\n\nIn Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.","conditions":["Metastatic Castration-resistant Prostate Cancer","Non-small Cell Lung Cancer","Triple Negative Breast Cancer","Metastatic Solid Tumor"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITC-6146RO"}],"enrollment":102,"startDate":"2026-03-24","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)\n2. Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent.\n3. Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease\n4. Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)\n5. Patients who have received standard therapies and have no remaining clinically available approved treatment options.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n7. Estimated life expectancy of ≥ 3 months\n\nExclusion Criteria:\n\n1. Inability to comply with study and follow-up procedures\n2. Patients with a prior history of anticancer therapy before the first dose\n3. History of another active malignancy within the past 3 years\n4. Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.\n5. Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO\n6. Has prior treatment with duocarmycin-containing agents\n7. Pregnancy, lactation, or breastfeeding\n8. Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.\n9. Tuberculosis with active disease\n10. Active infection necessitating systemic therapy\n11. Prior allogenic bone marrow transplantation or solid organ transplantation\n12. History of autoimmune disease, treatment with systemic immunosuppressive medications\n13. Patients with clinically significant pulmonary disease","locations":[{"facility":"Severance Hospital","city":"Seoul","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"EUNJU JEON, PhD","phone":"010-7557-3589","email":"ejjeon@intocell.com"},{"name":"SOOJIN OH, MS","phone":"010-7664-7484","email":"sjoh@intocell.com"}],"primaryOutcomes":["Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)","Phase 1b (Dose Expansion) Incidence of AEs"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer"],"drugSlugs":[],"locationSlugs":["seoul-south-korea"],"enrichment":{"headline":"Phase 1: testing ITC-6146RO for Metastatic Castration-resistant Prostate Cancer","inPlainEnglish":"The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD).","whoItsFor":["Ages 18 Years to any","Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)","Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease","Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3)","Patients who have received standard therapies and have no remaining clinically available approved treatment options","Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1","Estimated life expectancy of ≥ 3 months"],"whoShouldSkip":["Inability to comply with study and follow-up procedures","Patients with a prior history of anticancer therapy before the first dose","History of another active malignancy within the past 3 years","Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression","Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO","Has prior treatment with duocarmycin-containing agents","Pregnancy, lactation, or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are ITC-6146RO. The registry lists allocation as na. The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 102 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.962Z"},{"nctId":"NCT07423533","title":"Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD","officialTitle":"Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Disease-modifying Antirheumatic Drug","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Changchun GeneScience Pharmaceutical Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a multicenter, randomized, double-blind, parallel, placebo- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the efficacy and safety of GenSci120 injection in this patient population. The study consists of a screening period (≤ 4 weeks), a placebo-controlled treatment period (14 weeks), an extension treatment period (14 weeks), and a follow-up period (10 weeks), with a total of 17 scheduled visits.","conditions":["Rheumatoid Arthritis"],"keywords":["rheumatoid arthritis","GenSci120","inadequate response to at least one DMARD","Programmed death receptor-1 (PD-1)","Regulatory T cells"],"interventions":[{"type":"DRUG","name":"GenSci120 150 mg"},{"type":"DRUG","name":"GenSci120 600 mg"},{"type":"DRUG","name":"GenSci120 1000 mg"},{"type":"DRUG","name":"adalimumab injection 40 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":450,"startDate":"2026-04-30","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants who voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and are willing to strictly follow the clinical study protocol to complete this study;\n2. Male or female participants aged 18- 70 years (inclusive) when signing the informed consent form;\n3. Participants diagnosed with RA according to the 2010 RA classification criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), with ACR functional classification Class I-III at screening;\n4. Moderately to severely active RA is defined as TJC ≥ 6 and SJC ≥ 6 at screening and baseline based on 68/66 joint counts, and ESR or C-reactive protein (CRP)/hsCRP exceeding the upper limit of normal at screening. Joints with major surgery history will not be included in TJC and SJC;\n\nExclusion Criteria:\n\n1. Known allergy to any component in the GenSci120 formulation, or a history of allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.\n2. Any autoinflammatory disease or autoimmune disease (excluding secondary Sjogren's syndrome) other than RA, including but not limited to psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, systemic sclerosis or idiopathic inflammatory myopathy, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immunodeficiency syndrome, etc;\n3. Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;\n4. History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;\n5. Those with malignant disease or with a history of malignant disease;","locations":[{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei WANG","phone":"+86 18201085833","email":"wangwei13@genscigroup.com"},{"name":"Xi DENG","phone":"+86 18201085833","email":"dengxi@genscigroup.com"}],"primaryOutcomes":["Proportion of participants achieving the American College of Rheumatology 20% improvement criteria (ACR20) for disease activity assessment in RA from baseline after 14 weeks of administration"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":["adalimumab"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing GenSci120 150 mg for Rheumatoid Arthritis","inPlainEnglish":"This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel, dummy treatment (placebo)- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the how well it works and safety of GenSci120 injection in this patient population. The study consists of a screening period (≤ 4 weeks), a compared with a dummy treatment treatment period (14 weeks), an extension treatment period (14 weeks), and a follow-up period (10 weeks), with a total of 17 scheduled visits.","whoItsFor":["Ages 18 Years to 70 Years","Participants diagnosed with RA according to the 2010 RA classification criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), with ACR functional classification Class I-III at screening;"],"whoShouldSkip":["Known allergy to any component in the GenSci120 formulation, or a history of allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity","Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;","History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;","Those with malignant disease or with a history of malignant disease;"],"whatHappens":"If you join, the listed intervention(s) are GenSci120 150 mg, GenSci120 600 mg, or GenSci120 1000 mg. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel, dummy treatment (placebo)- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the how well it works and safety of GenSci120 injection in this patient population.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 450 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.271Z"},{"nctId":"NCT07424404","title":"A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents","officialTitle":"A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride in Children and Adolescents With Psychiatric Disorders","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents","conditions":["Schizophrenia","Autism-Related Irritability"],"keywords":["KarXT","Adolescent schizophrenia","Autism","Children and adolescents","Irritability"],"interventions":[{"type":"DRUG","name":"KarXT"},{"type":"DRUG","name":"KarX-EC"}],"enrollment":400,"startDate":"2026-04-07","completionDate":"2030-03-08","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participants must have completed the double-blind treatment period (ie, Visit 8) of Study CN0120020 or the double-blind treatment period (ie, Week 8) of Study CN0120044 or CN0120045 without an adverse event (AE) that, in the opinion of the investigator, may indicate an unacceptable safety risk.\n* De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL).\n\nExclusion Criteria\n\n* Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine psychiatric status examination, or those who are homicidal or are considered to be a high risk to others, or who have an answer of \"Yes\" on Questions 4 or 5 on the suicidal ideation section of the \"Since Last Visit\" version of the C-SSRS at baseline (Visit 1). Nonsuicidal, self-injurious behavior is not exclusionary.\n* Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the end of treatment visit of Study CN0120020, CN0120044 or CN00120045 that the investigator, in consultation with the Sponsor Medical Monitor, would jeopardize the safety of the participant.\n* Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Local Institution - 0054","city":"Dothan","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0163","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Center Inc.","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0159","city":"Anaheim","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inland Psychiatric Medical Group.","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proscience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0162","city":"Glendale","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0153","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0158","city":"Orange","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0174","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCSF Neurosciences Clinical Research Unit (NCRU)","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0157","city":"San Rafael","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0154","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0145","city":"Boca Raton","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0160","city":"Gainesville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0164","city":"Gainesville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Centers of America - Hollywood - CenExel - PPDS","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Apg Research, Llc","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0182","city":"Virginia Gardens","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0173","city":"Decatur","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Salveo Integrative Health - Lawrenceville","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Denali Health Atlanta, LLC","city":"Stone Mountain","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0175","city":"Chicago","state":"Illinois","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"EmVenio Research Center - Prime Healthcare","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0170","city":"Louisville","state":"Kentucky","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0132","city":"Lexington","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0059","city":"Worcester","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0152","city":"Bloomfield Hills","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0142","city":"Columbia","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0172","city":"Saint Charles","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0147","city":"Lincoln","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0144","city":"Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0146","city":"Neptune City","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0190","city":"Neptune City","state":"New Jersey","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0061","city":"Great Neck","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0171","city":"Orangeburg","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0156","city":"Staten Island","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0151","city":"The Bronx","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati Cancer Institute","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0148","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0139","city":"West Chester","state":"Ohio","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Local Institution - 0143","city":"Danville","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0150","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0137","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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0008","city":"Iași","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emergency Clinical Hospital For Children Louis Turcanu Timis","city":"Timișoara","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0101","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0099","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0098","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0100","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Number of participants with treatment emergent adverse events (TEAEs)","Number of participants with adverse events of special interest (AESIs)","Number of participants with serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["dothan-alabama","phoenix-arizona","anaheim-california","chino-california","culver-city-california","glendale-california","los-angeles-california","orange-california","san-diego-california","san-francisco-california","san-rafael-california","new-haven-connecticut","boca-raton-florida","gainesville-florida","hollywood-florida","orlando-florida","virginia-gardens-florida","atlanta-georgia","decatur-georgia","lawrenceville-georgia","stone-mountain-georgia","chicago-illinois","louisville-kentucky","boston-massachusetts","lexington-massachusetts","worcester-massachusetts","bloomfield-hills-michigan","columbia-missouri","saint-charles-missouri","lincoln-nebraska","las-vegas-nevada","neptune-city-new-jersey","great-neck-new-york","orangeburg-new-york","staten-island-new-york","the-bronx-new-york","cincinnati-ohio","west-chester-ohio","danville-pennsylvania","pittsburgh-pennsylvania","nashville-tennessee","dallas-texas","garland-texas","houston-texas","plano-texas","san-antonio-texas","spring-texas","orem-utah","west-point-utah","richmond-virginia","everett-washington","westmead-australia","brisbane-australia","melbourne-australia","calgary-canada","edmonton-canada","kingston-canada","toronto-canada","montreal-canada","bordeaux-france","bron-france","paris-france","budapest-hungary","gyula-hungary","szeged-hungary","kozhikode-india","nagpur-india","kanpur-india","chikugo-japan","sapporo-japan","zentsujich-japan","miyakonoj-japan","bunkyo-ku-japan","ta-ku-japan","yokohama-kanagawa-japan","poznan-poland","wroclaw-poland","warsaw-poland","gdansk-poland","szczecin-poland","katowice-poland","lublin-poland","zabrze-poland","san-juan-puerto-rico","bucharest-romania","cluj-napoca-romania","ia-i-romania","timi-oara-romania","barcelona-spain","madrid-spain"],"enrichment":{"headline":"Phase 3: testing KarXT for Schizophrenia","inPlainEnglish":"This study wants to measure the long-term whether it is safe and how hard side effects are to live with of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents","whoItsFor":["Ages 5 Years to 17 Years"],"whoShouldSkip":["Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN), regardless of the presence or absence of symptoms","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are KarXT, or KarX-EC. The registry lists allocation as randomized. This study wants to measure the long-term whether it is safe and how hard side effects are to live with of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 105 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.038Z"},{"nctId":"NCT07425522","title":"A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 in Participants With Diabetic Macular Edema (DME)","officialTitle":"A Phase I, Multicenter, Open-Label, Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of RO7823653 Administered by Intravitreal Injection as Monotherapy and in Combination With Faricimab in Patients With Diabetic Macular Edema","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as monotherapy and co-administered with faricimab.","conditions":["Diabetic Macular Edema"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7823653"},{"type":"DRUG","name":"Faricimab"}],"enrollment":93,"startDate":"2026-04-21","completionDate":"2028-11-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association\n* Glycated hemoglobin (HbA1c) \\<= 12%\n* For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \\>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters\n\nExclusion Criteria:\n\n* Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Uncontrolled blood pressure\n* For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant.\n* For Part 3: History of treatment with any of the following: Aflibercept 2 mg, ranibizumab, bevacizumab, or anti-VEGF biosimilars within 90 days prior to Day 1; Aflibercept 8 mg, brolucizumab, or faricimab within 120 days prior to Day 1; Triamcinolone acetonide (IVT, suprachoroidal, or periocular) within 120 days prior to Day 1; Dexamethasone intravitreal implant within 180 days prior to Day 1; Fluocinolone acetonide (FA) intravitreal implant within 3 years prior to Day 1; Device implant\n* History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye\n* Active intraocular inflammation in either eye\n* Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye","locations":[{"facility":"Associated Retina Consultants - Peoria - DocTrials - PPDS","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina-Vitreous Associates Medical Group","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bay Area Retina Specialists Medical Group - Vestrum - PPDS","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Associates of Florida","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wilmer Eye Institute","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erie Retina Research, LLC - 300 State St","city":"Erie","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wills Eye Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charles Retina Institute","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Research Institute of Texas","city":"Abilene","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Research, LLC","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas Westover Hills Retina Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Eye Center","city":"Lynchburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number GR46431 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With Ocular Adverse Events (AEs) and Systemic AEs"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["faricimab"],"locationSlugs":["peoria-arizona","beverly-hills-california","walnut-creek-california","st-petersburg-florida","baltimore-maryland","erie-pennsylvania","philadelphia-pennsylvania","germantown-tennessee","abilene-texas","austin-texas","san-antonio-texas","lynchburg-virginia"],"enrichment":{"headline":"Phase 1: testing RO7823653 for Diabetic Macular Edema","inPlainEnglish":"This study wants to measure the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as this drug alone and co-administered with faricimab.","whoItsFor":["Ages 18 Years to any","Diagnosis of diabetes mellitus (type 1 or type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association","Glycated hemoglobin (HbA1c) \\<= 12%","For study eye: Macular thickening secondary to DME involving the center of the fovea with central subfield thickness (CST) \\>= 325 micrometers (µm) as measured by SD-OCT and BCVA of 65 to 35 letters"],"whoShouldSkip":["Currently untreated diabetes mellitus or previously untreated participants who initiated oral anti-diabetic medication or insulin within 90 days prior to Day 1","Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required","Uncontrolled blood pressure","For Parts 1 and 2: Any history of ocular injection/implant therapy (e.g., anti-vascular endothelial growth factor agents (anti-VEGF), anti-VEGF/anti-angiopoietin-2 (Ang-2 agents), corticosteroids, device implant","History of uveitis, vitritis (grade trace or above), and/or scleritis in either eye","Active intraocular inflammation in either eye","Any previously documented or current proliferative diabetic retinopathy (PDR) in the study eye"],"whatHappens":"If you join, the listed intervention(s) are RO7823653, or Faricimab. The registry lists allocation as randomized. This study wants to measure the safety, tolerability, Pharmacodynamics (PD), and Pharmacokinetics (PK) of multiple doses of RO7823653 in participants with DME, administered by intravitreal (IVT) injection as this drug alone and co-administered with faricimab.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 93 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.127Z"},{"nctId":"NCT07425574","title":"A Study to Learn How Stargardt-type Eye Conditions Progress in Children and Adults","officialTitle":"An Observational Study of Natural Disease Progression in Participants With Macular Dystrophies Expressing a Stargardt-type Clinical Presentation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Astellas Pharma Global Development, Inc.","sponsorClass":"INDUSTRY","summary":"Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye. In people with macular dystrophies, some of the cells in the macula gradually stop working and may die over time. This leads to vision loss in the center of the eye. Side vision (peripheral vision) is mostly unaffected. Stargardt disease (STGD) is a type of macular dystrophy which is caused by 1 faulty gene (ABCA4). Vision loss most typically happens in childhood, but many people do not develop it until they are adults. As well as STGD, there are other macular dystrophies that look very similar to STGD but that are caused by many other different genes. Together, STGD and STGD-like conditions can be called STGD-type macular dystrophies. This is because they look the same clinically and have similar symptoms. Since different genes can cause these conditions, genetic testing is the only way to be sure which specific condition a person has.\n\nIn this study, researchers want to learn if the disease progresses in a similar way in people with STGD and STGD-like macular dystrophies. People taking part in the study will continue to manage their condition, as agreed with their own doctor. People will visit their clinic every 6 months to have various standard eye tests and imaging. The information collected will include questions about people's wellbeing, general health, medication and supplements taken, and daily activities.\n\nChildren over 6 years old and adults with STGD-type macular dystrophies may take part in this study. They will be in the study for up to 24 months (2 years). The study sponsor (Astellas) will not decide how people's condition is managed. However, the sponsor will provide instructions on when people visit their clinic and what is recorded during the study. If available, medical records, clinical and imaging data from previous visits going back 24 months will also be reviewed.","conditions":["Stargardt Disease","Stargardt Macular Dystrophy","Stargardt-like Macular Dystrophy"],"keywords":["Macular Dystrophies","Stargardt type","ABCA4 related STGD","STGD-like macular dystrophies"],"interventions":[{"type":"OTHER","name":"No Intervention"}],"enrollment":90,"startDate":"2026-02-20","completionDate":"2028-12-31","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant has a documented clinical diagnosis of macular dystrophy expressing a STGD-type clinical presentation and molecular confirmation, defined as either:\n\n  * ABCA4-associated disease: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD.\n  * STGD-like macular dystrophy: presence of one or more pathogenic variants in a gene known to cause macular dystrophy, as appropriate for its expected inheritance mode. Note: All genetic testing should be performed by a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent whenever possible. Acceptable documentation includes a copy of the genetic test report, laboratory certification statement, or clinical notes explicitly referencing CLIA certification. Predicted pathogenic variant of uncertain significance (VUS) that cannot be confirmed by standard laboratory criteria as certainly disease-causing (novel mutations) will be considered on a case by-case basis.\n* Participant has sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures.\n* Participant has intraocular pressure (IOP) both at screening and baseline of ≤ 21 mmHg measured by applanation tonometry. Note: Participant who is on topical IOP lowering treatment may also be included.\n* Participant has a spherical equivalent refractive error between + 8.00 D and - 10.00 D. Eyes with high myopia (\\> -10.00 D) are permitted only if there are no signs of myopic degenerative macular changes.\n* Participant has a BCVA ranging from 20/500 to 20/40 (equivalent to 15 to 70 ETDRS letters read at 1 meter)\n\n  * For participants in the \\> 20/80 to ≤ 20/40 BCVA range (moderate visual impairment \\[MVI\\]): presence of a visible definite or probable residual EZ on spectral-domain optical coherence tomography (SD-OCT) (no minimum residue size required) and a total retinal SD-OCT central subfield retinal thickness ≥ 150 µm\n  * For participants in the ≥ 20/500 to ≤ 20/80 BCVA range (SVI): presence of a residual outer nuclear layer (ONL) within the macular SD-OCT scan area and measurable within the Age-Related Eye Disease Study (AREDS) grading grid and no residual EZ or minimal thickness of the ONL required\n* Participant has evidence of retinal pigment epithelium (RPE) disease/damage on SD-OCT (hypertransmission defects \\[HTDs\\]) and/or FAF imaging.\n* Participant has evidence of at least questionably decreased autofluorescence (QDAF) (incomplete retinal pigment epithelial and outer retinal atrophy \\[iRORA\\]), defined as mottled or speckled hypo-autofluorescence (AF) signal, mixed with or without hyper- AF, on FAF imaging. Note: At study onset, having patches of definitely decreased autofluorescence (DDAF) within the FAF image and/or patches of complete retinal pigment epithelial and outer retinal atrophy (cRORA) on SD-OCT ≥ 250 µm will not be a requirement for participation but will be acceptable for inclusion, so long as:\n\n  * DDAF/cRORA areas are contained within the limits of the AREDS grading grid (≤ 12 disc areas), and physically distinct and separate from other areas of QDAF, DDAF and/or hyper-AF that may be present outside the AREDS grading grid, and\n  * the other BCVA and SD-OCT required inclusion criteria are also met.\n* Participant is able to comply with the protocol and willing to undertake all scheduled visits and assessments during the total study period.\n* Participant is deemed capable of performing reliably all tests required for participation.\n\nExclusion Criteria:\n\n* Participant has a known history of significant systemic disease (e.g., uncontrolled hepatitis, pancreatitis, cirrhosis, liver failure, uncontrolled thyroid disease or immunocompromising conditions such as human immunodeficiency virus \\[HIV\\]) that could impact ocular health or confound study assessments, based on medical history or prior clinical documentation.\n* Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and/or biologics that cause immunosuppression.\n* Participant has a known diagnosis of diabetes mellitus with a documented hemoglobin A1c (HbA1c) value ≥ 7% 3 months prior to screening and based on available medical records. If the documented HbA1c is ≥ 7% and there is no clinical history of diabetic symptoms, diabetic retinopathy, abnormal renal function (e.g., elevated creatinine), or glycosuria noted in medical records, the participant may be enrolled.\n* Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments.\n* Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV), clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months prior to screening.\n* Participant has a history or evidence of ventricular tachyarrhythmia requiring ongoing treatment.\n* Participant has a significant cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening.\n* Participant has any complicating systemic disease or active malignancy. Squamous cell carcinomas will be an exclusionary criterion if lesions are recurrent and/or \\> 2 cm in diameter and/or affect the lip or ear area. Basal cell carcinomas are permitted, provided they are not located in the immediate periocular facial region. A history of any prior malignancy is allowed if the treating physician or oncologist confirms that the participant has been free of recurrence or metastasis for at least 5 years prior to screening.\n* Participant has another known or suspected molecular diagnosis of macular or retinal disease (e.g., pathogenic mutations in other genes) that could confound interpretation of study outcomes, indicate a second concomitant retinal condition or suggest a different etiology for the macular disease.\n* Participant has evidence or history of choroidal neovascularization.\n* Participant has macular atrophy due to any cause other than a genetically or clinically confirmed diagnosis of STGD or STGD-like macular dystrophies.\n* Participant has a known diagnosis of any form of uncontrolled glaucoma (for high tension glaucoma IOP \\> 25 mmHg).\n* Participant has and/or is receiving treatment for thyroid eye disease.\n* Participant has diabetic retinopathy in excess of mild nonproliferative diabetic retinopathy (i.e., presents with widespread retinal microaneurysms, dot-blot hemorrhages, and cotton-wool retinal spots).\n* Participant has any other disease(s) affecting the optic nerve.\n* Participant has a history of anterior or posterior uveitis and/or presence of intraocular inflammation (≥ trace anterior chamber cell or flare), or history of idiopathic or autoimmune-associated uveitis in either eye. Note: A single, sporadic episode of anterior uveitis without recurrences in the past 5 years and not associated with chronic conditions that increase the likelihood of recurrence may be accepted on a case-by-case basis in consultation with the sponsor's medical monitor/lead.\n* Participant has corneal or lenticular opacities impeding the visualization of the fundus and/or the reliable performance of the visual function tests required by the protocol.\n* Participant has sufficiently narrow iridocorneal angles contraindicating pupillary dilation that have not been previously treated with preventative laser iridotomies.\n* Participant has any other ocular disorders that could interfere with or confound visual acuity and other ocular assessments, including OCT or FAF.\n* Participant has a clinically significant epiretinal membrane or evidence of clinically significant vitreomacular traction syndrome. Note: A mild enhancement of the vitreoretinal interface seen on OCT without any alteration of the foveal profile would not be considered an exclusion criterion.\n* Participant has presence of or recurrent vitreous hemorrhages. Note: A one-time episode of a traumatic vitreous hemorrhage would not result in exclusion, so long as resolved.\n* Participant has aphakia.\n* Participant has anticipated need for cataract surgery during the study period.\n* Participant has a macular hole, evident by ophthalmoscopy and/or by SD-OCT examinations, or history of prior macular hole surgery.\n* Participant has a history of any of the following procedures: posterior vitrectomy, retinal detachment surgery, glaucoma filtering surgery (e.g., trabeculectomy), glaucoma drainage device implantation, selective laser trabeculoplasty, full-thickness or partial-thickness corneal transplant (e.g., Descemet's stripping endothelial keratoplasty, Descemet's stripping automated endothelial keratoplasty or Descemet's membrane endothelial keratoplasty).\n* Participant has any lesion that is considered to pose a risk of retinal detachment during the study. Any preexisting lesion may be treated to allow eligibility, but treatment must be completed at least 3 months prior to screening.\n* Participant has had any prior thermal laser or photodynamic therapy treatment in the macular region, regardless of indication. Peripheral retinal thermal laser treatments for holes, lattice degeneration, and/or other lesions with rhegmatogenous potential are permitted within 3 months prior to screening, subject to their potential impact on a future pars plana vitrectomy surgery.\n* Participant has had any intraocular surgery within 3 months of screening.\n* Participant has a history of intraocular metallic foreign bodies.\n* Participant has received (or plans to receive during the study) any treatment including gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or any prior intravitreal treatment for any indication in either eye that may be considered to potentially interfere with the study participation or its conduct.\n* Participant is receiving concomitant treatment with any ocular or systemic medication known to be toxic to the lens, retina or optic nerve.\n\n  * Participant is using hydroxychloroquine (Plaquenil), chloroquine, pentosan polyphosphate (Elmiron), tamoxifen, chlorpromazine, thioridazine (Mellaril), isotretinoin (Accutane) or any related retina-toxic compounds at screening.\n* Participant has received (or plans to receive during the study) therapeutic radiation in the region of the study eye.\n* Participant has had (or plans to have during the study) any major surgical procedure within 1 month prior to screening or anticipates having one during the study, which may interrupt study participation.\n* Participant is taking glucagon-like peptide-1 (GLP-1) receptor agonists and is unable or unwilling to stop the medication at least 4 weeks prior to screening. A history of treatment with a GLP-1 receptor agonist is allowed.\n* Participant is taking metformin and is unable or unwilling to stop this medication at least 4 weeks prior to screening. A history of treatment with metformin is allowed.\n* Participant is participating (or plans to participate) in an interventional study of a vitamin A metabolism inhibitor, a vitamin A analog/derivative, or another investigational drug product within 3 months prior to screening. After a 3 month washout period, participants can be considered for enrollment. Participation in a noninterventional study (NIS) is allowed.\n* Participant has a known or suspected hypersensitivity to eyedrops used for IOP measurement or pupil dilation.\n* Participant has any condition that makes the participant unsuitable for study participation.","locations":[{"facility":"Associated Retina Consultants","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford University School of Medicine","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Health - UC Davis","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida Health - UF Health Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Health System - Bascom Palmer Eye Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois Chicago - UI Health","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Health - Kellogg Eye Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deep Blue Retina","city":"Southaven","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Eye Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Eye Institute","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Casey Eye Institute - Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wills Eye Physicians - Mid Atlantic Retina","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Foundation of the Southwest","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Health - John A Moran Eye Center","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Astellas Pharma Global Development, Inc.","phone":"800-888-7704","email":"Astellas.registration@astellas.com"}],"primaryOutcomes":["Change from baseline in best corrected visual acuity (BCVA) at month 12"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","palo-alto-california","sacramento-california","jacksonville-florida","miami-florida","chicago-illinois","ann-arbor-michigan","southaven-mississippi","durham-north-carolina","cincinnati-ohio","portland-oregon","philadelphia-pennsylvania","pittsburgh-pennsylvania","dallas-texas","salt-lake-city-utah"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention for Stargardt Disease","inPlainEnglish":"Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye.","whoItsFor":["Ages 6 Years to any","Participant has a documented clinical diagnosis of macular dystrophy expressing a STGD-type clinical presentation and molecular confirmation, defined as either:","ABCA4-associated disease: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD","Participant has sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures","Participant has intraocular pressure (IOP) both at screening and baseline of ≤ 21 mmHg measured by applanation tonometry. Note: Participant who is on topical IOP lowering treatment may also be included","Participant has a spherical equivalent refractive error between + 8.00 D and - 10.00 D. Eyes with high myopia (\\> -10.00 D) are permitted only if there are no signs of myopic degenerative macular changes","Participant has a BCVA ranging from 20/500 to 20/40 (equivalent to 15 to 70 ETDRS letters read at 1 meter)","Participant has evidence of retinal pigment epithelium (RPE) disease/damage on SD-OCT (hypertransmission defects \\[HTDs\\]) and/or FAF imaging"],"whoShouldSkip":["Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and/or biologics that cause immunosuppression","Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments","Participant has a history or evidence of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV), clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months prior to screening","Participant has a history or evidence of ventricular tachyarrhythmia requiring ongoing treatment","Participant has a significant cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening","Participant has evidence or history of choroidal neovascularization","Participant has macular atrophy due to any cause other than a genetically or clinically confirmed diagnosis of STGD or STGD-like macular dystrophies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 90 people at 15 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.151Z"},{"nctId":"NCT07428447","title":"Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease","officialTitle":"Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"CND Life Sciences","sponsorClass":"OTHER","summary":"Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually. Post-mortem studies reveal Lewy body pathology in some ET patients, suggesting a subset may have prodromal PD. Current diagnostic tools (DaTscan, SYNTap) are either insufficiently sensitive for early disease, too expensive, or too invasive for routine screening. The Syn-One Test offers a minimally invasive approach to detect phosphorylated α-synuclein (P-SYN) pathology in skin biopsies.\n\nPrimary Objectives\n\n1. Identify which ET patients have P-SYN pathology indicative of prodromal PD\n2. Predict which patients are most likely to phenoconvert to PD","conditions":["Essential Tremor, Movement Disorders","Essential Tremor","Essential Tremor-plus"],"keywords":["skin biopsy","Syn-One"],"interventions":[],"enrollment":300,"startDate":"2026-02-18","completionDate":"2027-02","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 50-85 years old\n* Diagnosis of ET as defined by the 2018 MDS Task force paper \"1) isolated tremor syndrome of bilateral upper limb action tremor 2) at least 3 years' duration 3) with or without tremor in other locations (e.g., head, voice, or lower limbs) 4) absence of other neurological signs, such as dystonia, ataxia, or parkinsonism.\" OR\n* Diagnosis of ET-Plus as stated by the 2018 MDS Task force paper, \"Tremor with the characteristics of ET and additional neurological signs of uncertain significance such as impaired tandem gait, questionable dystonic posturing, memory impairment, or other mild neurologic signs of unknown significance that do not suffice to make an additional syndrome classification or diagnosis. ET with tremor at rest should be classified here.\"\n* Willing to participate in all study procedures\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Under age 50, Over age 85\n* Clinical evidence of severe peripheral vascular disease\n* Clinically active coronary artery or cerebrovascular disease\n* Participant is currently on anticoagulant or dual anti-platelet therapy\n* Alcoholism\n* Allergic reaction to local anesthesia\n* History of or increased risk for impaired wound healing, scarring, or keloid formation\n* Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise\n* History of other neurodegenerative disorder or evidence of neurological co-pathology\n* Abnormal DaTscan\n* Participant is currently receiving treatment with carbidopa-levodopa for PD\n* Isolated focal tremors (head, voice)\n* Task-specific tremor (e.g., primary writing tremor)\n* Position-specific tremors that does not otherwise meet clinical diagnostic criteria for ET\n* Sudden onset and step-wise deterioration\n* Prior to enrollment, receipt of an intracranial procedure intended to treat tremor or parkinsonism, including thalamic deep brain stimulation (DBS) implantation or focused ultrasound (FUS) thalamotomy. Other prior intracranial surgery is exclusionary only when, in the investigator's or Sponsor's Chief Medical Officer's judgment, it could materially affect motor assessments, diagnostic classification, participant safety, or interpretation of study outcomes.","locations":[{"facility":"CND Clinical Research Center","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Movement Disorders Center of Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Irvine Health","city":"Irvine","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Neurology One","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Healthcare","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quest Research Institute","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Veracity Neurosciences LLC","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeannie Director of Clinical Research","phone":"480-434-6446","email":"ClinicalResearch@cndlifesciences.com"}],"primaryOutcomes":["Quantity of P-SYN in skin","Rate of Phenoconversion"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","irvine-california","los-angeles-california","orlando-florida","kansas-city-kansas","louisville-kentucky","farmington-hills-michigan","memphis-tennessee","nashville-tennessee","houston-texas"],"enrichment":{"headline":"Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essen…","inPlainEnglish":"Background and Rationale Essential tremor (ET) affects over 6 million Americans and approximately 5% of adults over age 60. Patients with ET have a 10-20 times higher risk of developing Parkinson's disease (PD) compared to age-matched populations, with approximately 1% converting to PD annually.","whoItsFor":["Ages 50 Years to 85 Years","Age 50-85 years old"],"whoShouldSkip":["Under age 50, Over age 85","Clinical evidence of severe peripheral vascular disease","Clinically active coronary artery or cerebrovascular disease","Participant is currently on anticoagulant or dual anti-platelet therapy","Allergic reaction to local anesthesia","History of or increased risk for impaired wound healing, scarring, or keloid formation","Diagnosis of ET or ET-Plus that is clinically determined to likely be secondary to brain injury or vascular compromise"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 11 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.660Z"},{"nctId":"NCT07428993","title":"Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma","officialTitle":"A Phase II Study Evaluating Efficacy of B7-H3-CAR T Cells Administered at the End of Upfront Map Chemotherapy in Patients With Newly Diagnosed High-Risk Osteosarcoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"St. Jude Children's Research Hospital","sponsorClass":"OTHER","summary":"The purpose of this study is to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy.\n\nPrimary Objectives:\n\n\\- To evaluate 1-year RFS from the time of SJCARB7H3-41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy.\n\nSecondary Objectives:\n\n* To evaluate the OS from time of SJCARB7H3-41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy.\n* To evaluate the feasibility of delivering SJCARB7H3-41BBL at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.\n* To describe the safety of autologous SJCARB7H3-41BBL therapy when delivered at the end of standard therapy in patients with newly diagnosed metastatic osteosarcoma.","conditions":["Pediatric Osteosarcoma"],"keywords":["Osteosarcoma"],"interventions":[{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"},{"type":"DRUG","name":"Mesna"},{"type":"PROCEDURE","name":"Apheresis"},{"type":"PROCEDURE","name":"SJCARB7H3_41BBL infusion"}],"enrollment":41,"startDate":"2026-08-21","completionDate":"2034-12","sex":"ALL","minAge":null,"maxAge":"21 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant and/or legally authorized representative has signed the Informed Consent Form for this study\n2. Prior cancer therapy:\n\n   * Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior.\n   * Regimen B only: has completed all planned cycles of consolidation chemotherapy at least 14 days prior and if clinically indicated, participant has undergone pulmonary metastasectomy. They must have recovered from any surgical complications with no ongoing sequelae of category 2 or higher by the Clavien-Dindo classification system and less than 6 weeks must have passed from time of pulmonary metastasectomy.\n3. No evidence of progressive disease since enrolled on study\n4. Lansky performance status score of ≥ 50 for participants \\<16 years of age or Karnofsky score ≥ 50 for participants ≥ 16 years. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status\n5. Adequate organ function as indicated by:\n\n   * Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) based on enrollment eligibility table.\n   * Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN\n   * Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram\n   * Respiratory: Oxygen saturation ≥ 90% on room air without supplemental oxygen or mechanical ventilation\n6. Laboratory values meet the following criteria:\n\n   * Absolute Neutrophil Count (ANC) ≥ 750 cells/uL\n   * Platelet Count of ≥ 75,000 (can be transfused)\n   * Hemoglobin ≥ 7 g/dL (can be transfused)\n7. Participant is ≥ 7 days from receiving supra-physiologic dosing of systemic (IV or PO) corticosteroids. Glucocorticosteroid physiologic replacement therapy for management of adrenal insufficiency is allowed.\n8. Participant and/or legally authorized representative has signed the Informed Consent Form for the treatment phase of this study.\n\nExclusion Criteria:\n\n1. Major surgical adverse event related to the primary tumor local control defined as Clavien-Dindo category 3 requiring ongoing wound care.\n2. Evidence of clinically significant encephalopathy/new focal neurologic deficits.\n3. Presence of active severe infection, defined as:\n\n   * positive blood culture within 48 hours of enrollment, OR\n   * fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment\n4. Participant has received prior disease-directed therapy other than 1st line therapy with methotrexate, an anthracycline, and a platinum and local control surgery\n\n   • Regimen B only - okay to have undergone initial pulmonary metastasectomy\n5. Pregnant or breastfeeding\n6. Presence of any condition that, in the opinion of the investigator, would prohibit the participant from undergoing treatment under this protocol","locations":[{"facility":"St. Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie Park, MD","phone":"888-226-4343","email":"referralinfo@stjude.org"},{"name":"Judith Durrell","phone":"888-226-4343","email":"referralinfo@stjude.org"}],"primaryOutcomes":["Event-free survival (EFS), defined as time from SJCARB7H3-41BBL infusion to disease relapse, progressive disease, new systemic therapy, secondary malignancy or death"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["memphis-tennessee"],"enrichment":{"headline":"Phase 2: testing Cyclophosphamide for Pediatric Osteosarcoma","inPlainEnglish":"This study wants to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy. Primary Objectives: \\- To evaluate 1-year RFS from the time of SJCARB7H3-41BBL infusion for patients with newly diagnosed metastatic osteosarcoma who received standard chemotherapy.","whoItsFor":["Ages any to 21 Years","Prior cancer therapy:","Regimen A only: Completed all planned cycles of consolidation therapy between 14-28 days prior","No evidence of progressive disease since enrolled on study","Adequate organ function as indicated by:","Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN) based on enrollment eligibility table","Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN","Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram"],"whoShouldSkip":["Major surgical adverse event related to the primary tumor local control defined as Clavien-Dindo category 3 requiring ongoing wound care","Evidence of clinically significant encephalopathy/new focal neurologic deficits","Presence of active severe infection, defined as:","positive blood culture within 48 hours of enrollment, OR","fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment","Participant has received prior disease-directed therapy other than 1st line therapy with methotrexate, an anthracycline, and a platinum and local control surgery","Regimen B only - okay to have undergone initial pulmonary metastasectomy"],"whatHappens":"If you join, the listed intervention(s) are Cyclophosphamide, Fludarabine, or Mesna. The registry lists allocation as na. This study wants to assess the safety, feasibility, and effectiveness of a consolidative B7-H3 CAR T cell therapy in patients with newly diagnosed high-risk osteosarcoma who have undergone upfront standard chemotherapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 41 people at Memphis. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.410Z"},{"nctId":"NCT07430202","title":"A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)","officialTitle":"A Phase 1b Study of a DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab for Patients With Advanced Stage Fibrolamellar Hepatocellular Carcinoma (FLC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins","sponsorClass":"OTHER","summary":"The purpose of this study is to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).","conditions":["Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))"],"keywords":["Fibrolamellar Carcinoma (FLC)","Liver Cancer","DNAJB1-PRKACA Fusion Kinase Peptide Vaccine","DRP-104 (glutamine antagonist peptide)","Nivolumab","Ipilimumab","Immunotherapy","Anti PD-L1 (Anti-Programmed Death Ligand 1)","PD-L1 (Programmed Death Ligand 1)","Carcinoma","Glutamine antagonist"],"interventions":[{"type":"DRUG","name":"DNAJB1-PRKACA Peptide Vaccine"},{"type":"DRUG","name":"DRP-104"},{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Ipilimumab"}],"enrollment":27,"startDate":"2026-10-28","completionDate":"2030-10","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have histologically confirmed FLC that is metastatic or unresectable.\n* Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue.\n* Must have demonstrated radiographic progression on prior or current immunotherapy.\n* Age ≥ 12 years.\n* Patients \\< 18 years old must have a body weight ≥ 40 kg.\n* ECOG (Eastern Cooperative Oncology Group) performance status of ≤2\n* Patients must have adequate organ and marrow function defined by study-specified laboratory tests.\n* Patients must have adequate kidney and liver function defined by study-specified laboratory tests.\n* Must have measurable disease per RECIST 1.1\n* Willingness to provide tissue and blood samples for mandatory translational research.\n* Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test.\n* For both Women and Men, must use acceptable form of birth control while on study.\n* Ability to understand and willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies.\n* Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:\n\n  * Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug.\n  * Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures.\n  * Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug.\n* Patients who have not recovered from acute adverse events to grade ≤1 or baseline due to agents administered, with exception of grade 2 fatigue, rash, and endocrinopathy successfully managed hormone replacement therapy, or alopecia or stable neuropathy, unless approved by the IND Sponsor.\n* Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment.\n* Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and/or DRP-104 and/or nivolumab and/or ipilimumab.\n* History of severe hypersensitivity reaction to any monoclonal antibody.\n* Has an active autoimmune disease.\n* Prior allogeneic stem cell transplantation or organ transplantation.\n* Has a diagnosis of immunodeficiency.\n* Systemic corticosteroids at immunosuppressive doses.\n* Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Has a pulse oximetry of \\<92% on room air or is on supplemental home oxygen.\n* Active or untreated brain metastases or leptomeningeal metastases.\n* Uncontrolled intercurrent active medical and/or psychiatric illness/social psychosocial problems that that would limit compliance with study requirements.\n* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia, metastatic cancer, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Pregnant or breastfeeding.\n* Has a known history of Human Immunodeficiency Virus (HIV)/AIDS.\n* Has active hepatitis B. Patients with chronic or acute HBV infection.\n* Have had evidence of active or acute diverticulitis, intra-abdominal abscess, or GI obstruction which are known risk factors for bowel perforation should be evaluated for the potential need for additional treatment before coming on study.\n* Unwilling or unable to follow the study schedule for any reason.\n* Patient is at the time of signing informed consent a regular user (including \"recreational use\") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol).\n* Evidence of clinical ascites.\n* Patients with QTc prolongation \\> 470 ms according to Fridericia formula.\n* Patients receiving potent inducers of CYP 3A4/5 (including but not limited to apalutamide, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin and St. John's Wort) who cannot safely discontinue drug at least 14 days prior to Cycle 1 Day 1.\n* Have had an allergen hyposensitization therapy within 2 weeks prior to initiation of study treatment.","locations":[{"facility":"Johns Hopkins SKCCC","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Colleen Apostol, RN","phone":"410-614-3644","email":"GIClinicalTrials@jhmi.edu"}],"primaryOutcomes":["Number of participants experiencing grade 3 or above drug-related toxicities","Objective response rate (ORR) using immune Response Evaluation Criteria for Solid Tumors (RECIST 1.1)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":["nivolumab"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1: testing DNAJB1-PRKACA Peptide Vaccine for Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))","inPlainEnglish":"This study wants to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1). Secondary objectives include progression-free survival (PFS) and overall survival (OS).","whoItsFor":["Ages 12 Years to any","Must have histologically confirmed FLC that is metastatic or unresectable","Presence of DNAJB1-PRKACA fusion transcript, assessed by RNA-sequencing, DNA-sequencing, or in situ hybridization in the archival tissue","Must have demonstrated radiographic progression on prior or current immunotherapy","Patients \\< 18 years old must have a body weight ≥ 40 kg","ECOG (Eastern Cooperative Oncology Group) performance status of ≤2","Patients must have adequate organ and marrow function defined by study-specified laboratory tests","Patients must have adequate kidney and liver function defined by study-specified laboratory tests"],"whoShouldSkip":["Patients with a history of prior treatment with checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, anti-CTLA-4, or anti-LAG-3 antibodies","Must have had chemotherapy or other systemic therapy or radiotherapy, as follows:","Patients who have had chemotherapy, biological cancer therapy, or radiation 14 days prior to the first dose of study drug","Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures","Patients who have received other approved or investigational agents or device within 28 days of the first dose of study drug","Patients who have received any non-oncology live vaccine therapy used for prevention of infectious diseases within 28 days of study treatment","Known sensitivity to or history of allergic reactions attributed to compounds of similar chemical or biologic composition of polyinosinic-polycytidylic acid (Poly-ICLC) and/or DRP-104 and/or nivolumab and/or ipilimumab"],"whatHappens":"If you join, the listed intervention(s) are DNAJB1-PRKACA Peptide Vaccine, DRP-104, or Nivolumab. The registry lists allocation as na. This study wants to determine whether the combination of a neoantigen vaccine targeting the DNAJB1-PRKACA fusion kinase in combination with DRP-104, Nivolumab and Ipilimumab is safe and yields a clinically compelling antitumor activity measured as based on objective response rate (ORR, assessed by RECIST 1.1).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 27 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.627Z"},{"nctId":"NCT07430306","title":"A Study to Evaluate the Treatment Outcomes of Subcutaneous Anifrolumab in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus","officialTitle":"Multinational, Interventional, 52-week, Open-label, Single-arm Study to Evaluate the Treatment Outcomes of Anifrolumab 120 mg Subcutaneous Once Weekly in Immunosuppressant-naïve and Biologic-naïve Systemic Lupus Erythematosus (SUNFLOWER)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.\n\nPatients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment. The study will also employ a tapering protocol for a systematic approach to GC tapering, seeking to understand better the proportion of patients in remission who can successfully withdraw chronic GC completely.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Lupus","Immunosuppressant","Glucocorticoid","Anifrolumab","Remission"],"interventions":[{"type":"DRUG","name":"Anifrolumab"}],"enrollment":245,"startDate":"2026-04-13","completionDate":"2029-01-26","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Males or females aged 18 to 70 years of age.\n2. Participants who have a diagnosis of SLE confirmed by a rheumatologist.\n3. ANA-positive per the Central Lab at screening:\n\n   (a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)\n4. Must be on the standard therapy regimen: antimalarials with or without OCSs\n5. Must have at screening and baseline:\n\n   1. Clinical SLEDAI-2K ≥ 4 points OR\n   2. Clinical SLEDAI-2K \\< 4 with GC dose ≥ 7.5 mg/day (prednisone equivalent)\n6. Should have no evidence of current active infection, (e.g., pneumonia, tuberculosis \\[TB\\]) or previous TB\n7. Should have no evidence of malignancy; and clinically significant abnormalities (unless due to SLE).\n8. No medical history or signs or symptoms of active TB prior to or during Screening.\n9. Body weight ≥ 40.0 kg\n10. Negative pregnancy test for females during screening\n11. Normal HPV test result within 2 years prior to Week 0 (Day 1).\n12. Willing and able to participate in all required study evaluations and procedures including completion of PROs.\n13. Willing to not use any other forms of experimental treatment during the study.\n\nExclusion Criteria:\n\n1. Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome.\n2. Subjects with antiphospholipid antibody syndrome on stable anticoagulant therapy at an effective dose (e.g., if on warfarin, an international normalized ratio \\[INR\\] target 2 to 3 or as appropriate for the clinical situation) are only allowed if this is not the sole or the predominant feature of their SLE.\n3. Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded.\n4. Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism.\n5. Subjects with a history of 3 or more unexplained consecutive pregnancy losses.\n6. History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening.\n7. Active severe or unstable neuropsychiatric SLE including, but not limited to aseptic meningitis, cerebral vasculitis, myelopathy, demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy), acute confusional state, impaired level of consciousness, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus, cerebellar ataxia, lupus headache and mononeuritis multiplex, where, protocol-specified standard therapy is insufficient.\n8. Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient.\n9. Current diagnosis of, catastrophic antiphospholipid syndrome (APS).\n10. History of recurrent infection requiring hospitalization and IV antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks).\n11. Known History of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for HIV at Screening.\n12. Confirmed positive test for hepatitis B.\n13. Any clinical cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to signing the ICF.\n14. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years of Week 0 (Day 1).\n15. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to signing the ICF (chronic nail infections are allowed).\n16. Severe HZ or recurrent HZ.\n17. Malignancy. History of cancer, apart from:\n\n    (a) Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy ≥ 3 months prior to Week 0 (Day 1).\n\n    (a) Cervical cancer in situ treated with apparent success with curative therapy ≥ 1 year prior to Week 0 (Day 1).\n18. Received any SLE-related therapies other than antimalarials and GCs.\n19. History of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy.\n20. History of an anaphylactic reaction to human proteins or mAbs.\n21. Received any live or attenuated vaccine within 8 weeks prior to signing the ICF.\n22. Blood transfusion or receipt of blood products except albumin.\n23. Received more than 2 investigational products for the SLE since time of diagnosis.\n24. Received any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to signing of the ICF, whichever is greater.\n25. Concurrent enrollment in another clinical study with a study intervention.\n26. Subjects with any abnormal lab result as specified in the protocol.\n27. Subjects with other autoimmune diseases (e.g., multiple sclerosis, psoriasis, IBD, etc.).\n28. Subjects with SLE overlap syndromes such as scleroderma and mixed connective tissue disease.\n29. Subject with non-SLE concomitant illness, as determined by medical judgment, who is likely to require additional systemic glucocorticosteroid therapy during the study (e.g., asthma).\n30. Any condition would interfere with treatment outcomes of the study intervention or put participant at safety risk.\n31. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding anytime from initiation of Screening until 16 weeks following last dose of study intervention.\n32. Spontaneous or induced abortion, still or live birth, or pregnancy ≤ 4 weeks prior to signing the ICF.\n33. Current alcohol, drug or chemical abuse, or a history of such abuse within 1 year before Week 0 (Day 1).\n34. Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.","locations":[{"facility":"Research Site","city":"Anniston","state":"Alabama","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fontana","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"La Palma","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Menifee","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Leandro","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Temecula","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Brandon","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"St. Petersburg","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research 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Site","city":"Culiacán","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Durango","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guadalajara","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mérida","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"México","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Częstochowa","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research 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3: testing Anifrolumab for Systemic Lupus Erythematosus","inPlainEnglish":"The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment. Patients will be naïve to any prior conventional immunosuppressant including prior biologic therapy at enrolment.","whoItsFor":["Ages 18 Years to 70 Years","Males or females aged 18 to 70 years of age","Participants who have a diagnosis of SLE confirmed by a rheumatologist","ANA-positive per the Central Lab at screening:","(a) ANA (b) Anti-dsDNA (c) Anti-Smith (anti-Sm)","Must be on the standard therapy regimen: antimalarials with or without OCSs","Must have at screening and baseline:","Clinical SLEDAI-2K ≥ 4 points OR"],"whoShouldSkip":["Subjects with history of, or current diagnosis of, a clinically significant non-SLE related vasculitis syndrome","Subjects with a serious thrombotic event (e.g., pulmonary embolism stroke, deep vein thrombosis) or unexplained pregnancy loss within 1 year before the screening visit are excluded","Subjects with a history of catastrophic antiphospholipid syndrome or saddle embolism","Subjects with a history of 3 or more unexplained consecutive pregnancy losses","History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia Suicide Severity Rating Scale (C SSRS) at Screening","Active severe SLE-driven renal disease where, protocol-specified standard therapy is insufficient","Current diagnosis of, catastrophic antiphospholipid syndrome (APS)"],"whatHappens":"If you join, the listed intervention(s) are Anifrolumab. The registry lists allocation as randomized. The purpose of the SUNFLOWER study is to describe clinical outcomes, including DORIS remission, achieved following the initiation of anifrolumab 120 mg SC once weekly (QW) as add-on therapy to an anti-malarial, with or without GC; in patients not in LLDAS at enrolment.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 245 people at 89 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.265Z"},{"nctId":"NCT07430956","title":"Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable","officialTitle":"A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called \"study drugs\"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots.\n\nREGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN7508 or REGN9933\n* How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo\n* How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo\n* How well does REGN7508 or REGN9933 lower the risk of death compared to placebo\n* How much REGN7508 or REGN9933 is in the blood at different times\n* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)","conditions":["Atrial Fibrillation (AF)"],"keywords":["Blood clots","Ischemic stroke","Systemic embolism","Pulmonary embolism","Venous Thromboembolism (VTE)"],"interventions":[{"type":"DRUG","name":"REGN7508"},{"type":"DRUG","name":"REGN9933"},{"type":"DRUG","name":"Placebo"}],"enrollment":2628,"startDate":"2026-04-03","completionDate":"2029-03-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause\n2. At moderate to high risk for stroke defined as:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥4 OR\n   2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol\n3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Had an ischemic stroke within 2 days prior to randomization\n3. Has persistent, uncontrolled hypertension (per investigator's discretion)\n4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization\n5. Has a life expectancy less than 12 months\n6. 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Research, Inc","city":"Johns Creek","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscan Physician Network, Indiana Heart Physicians","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana Medical Research","city":"Merrillville","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research, Powers Health Medical Group - Electrophysiology","city":"Munster","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Research, LLC","city":"West Monroe","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills","city":"Bloomfield Hills","state":"Michigan","country":"United 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bleeding"],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["dothan-alabama","glendale-arizona","little-rock-arkansas","fremont-california","huntington-beach-california","la-jolla-california","northridge-california","pasadena-california","santa-maria-california","ventura-california","west-hills-california","jacksonville-florida","medley-florida","pensacola-florida","sarasota-florida","winter-park-florida","atlanta-georgia","johns-creek-georgia","indianapolis-indiana","merrillville-indiana","munster-indiana","west-monroe-louisiana","bloomfield-hills-michigan","farmington-hills-michigan","flint-michigan","jackson-mississippi","olive-branch-mississippi","staten-island-new-york","concord-north-carolina","marion-ohio","anderson-south-carolina","rapid-city-south-dakota","tullahoma-tennessee","amarillo-texas","brownsville-texas","dallas-texas","houston-texas","lufkin-texas","mckinney-texas","missouri-city-texas","vienna-virginia","hamilton-canada"],"enrichment":{"headline":"Phase 3: testing REGN7508 for Atrial Fibrillation (AF)","inPlainEnglish":"This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called \"study drugs\"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.","whoItsFor":["Ages 18 Years to any","Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause","At moderate to high risk for stroke defined as:","CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥4 OR","CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol","Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol"],"whoShouldSkip":["Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)","Had an ischemic stroke within 2 days prior to randomization","Has persistent, uncontrolled hypertension (per investigator's discretion)","Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization","Has a life expectancy less than 12 months","Has participated in a prior Factor XI (FXI) inhibitor study","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are REGN7508, REGN9933, or Placebo. The registry lists allocation as randomized. This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called \"study drugs\").","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,628 people at 45 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.212Z"},{"nctId":"NCT07431827","title":"MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)","officialTitle":"A Phase 3, Randomized, Double-blind Study of Adjuvant MK-1084 Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) Versus Adjuvant Placebo Plus MK-3475A in Participants With Completely Resected Stage IIA-IIIB (N2), KRAS G12C-mutant Non-small Cell Lung Cancer Following Receipt of Either Neoadjuvant Pembrolizumab Plus Chemotherapy or Adjuvant Chemotherapy (KANDLELIT-013)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"This is a phase 3, randomized, double-blind study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant placebo plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant placebo plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Calderasib"},{"type":"BIOLOGICAL","name":"MK-3475A"},{"type":"DRUG","name":"Placebo"}],"enrollment":400,"startDate":"2026-03-18","completionDate":"2039-10-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:\n\n  * Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC\n  * Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy.\n* Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation\n* No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention.\n* Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization\n* Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention\n* Human immunodeficiency virus-infected participants must have well controlled HIV on antiretroviral therapy\n* Participants who are Hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention\n* Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. 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3: testing Calderasib for Non-small Cell Lung Cancer","inPlainEnglish":"This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant dummy treatment (placebo) plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy. The primary goal of the study is to compare adjuvant calderasib plus MK-3475A to adjuvant dummy treatment (placebo) plus MK-3475A with respect to disease-free survival (DFS) as assessed by the investigator.","whoItsFor":["Ages 18 Years to any","Has a histological/cytological diagnosis of non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology and meets one of the following criteria:","Has newly diagnosed, treatment-naïve, resectable, clinical Stage IIA-IIIB (N2) NSCLC","Has completely resected, pathological Stage IIA-IIIB (N2) NSCLC, including those previously treated outside the study with neoadjuvant platinum-doublet chemotherapy plus pembrolizumab or MK-3475A, or those who received adjuvant platinum-doublet chemotherapy","Tumor tissue shows the presence of Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation","No more than 12 weeks have elapsed between either the surgery following neoadjuvant treatment or last dose of adjuvant platinum-based chemotherapy and the first dose of investigational adjuvant study intervention","Has no evidence of disease based on postsurgical radiological assessment as documented by contrast-enhanced chest/abdomen computed tomography (or magnetic resonance imaging) within 28 days before randomization","Has an Eastern Cooperative Oncology Group performance status of 0 or 1 within 10 days before the first dose of the study intervention"],"whoShouldSkip":["Has a diagnosis of any 1 of the following tumor types/locations: small cell lung cancer or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or NSCLC involving the superior sulcus","HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, chronic diarrhea)","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention","Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction, or malabsorption)","Has known additional malignancy that is progressing or has required active treatment within the past 3 years","Has an active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy"],"whatHappens":"If you join, the listed intervention(s) are Calderasib, MK-3475A, or Placebo. The registry lists allocation as randomized. This is a phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment study of adjuvant calderasib plus subcutaneous pembrolizumab and berahyaluronidase alfa (MK-3475A) versus adjuvant dummy treatment (placebo) plus MK-3475a in participants with completely resected stage IIA-IIIB (N2), KRAS G12C-mutant non-small cell lung cancer following receipt of either neoadjuvant pembrolizumab plus chemotherapy or adjuvant chemotherapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 122 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.741Z"},{"nctId":"NCT07436663","title":"Comparative Study Between (SGLT-2i) and (DPP-4i) in the Prevention of DIC","officialTitle":"A Comparative Clinical Study Evaluating the Efficacy of (SGLT2)Inhibitors Versus (DPP-4) Inhibitors in the Prevention of Doxorubicin-Induced Cardiotoxicity Among Egyptian Women With Breast Cancer","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Tanta University","sponsorClass":"OTHER","summary":"Background:\n\nBreast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure. The search for effective cardioprotective interventions is therefore a key priority in cardio-oncology.\n\nAim:\n\nThis study aims to compare the efficacy of sodium-glucose cotransporter 2 (SGLT2) inhibitors and dipeptidyl peptidase-4 (DPP-4) inhibitors in preventing doxorubicin-induced cardiotoxicity in Egyptian women with breast cancer.\n\nMethods:\n\nA prospective, randomized, controlled clinical trial will be conducted at Oncology Hospital of Tanta University. Eligible adult female patients with histologically confirmed breast cancer scheduled to receive anthracycline-containing chemotherapy will be randomized into three groups: (1) control (standard care), (2) SGLT2 inhibitor group (dapagliflozin 10-25 mg daily), and (3) DPP-4 inhibitor group (sitagliptin 50-100 mg daily). Treatment will start five days before the first chemotherapy cycle and continue for six months, with follow-up for an additional six months. Cardiac function will be assessed by echocardiography (LVEF and GLS) and biomarkers (Cardiac Troponin T, and NT-proBNP). The primary endpoint is the incidence of cardiotoxicity defined by a ≥10% decline in LVEF to \\<50% or a \\>15% relative decline in GLS accompanied by biomarker elevation.\n\nExpected Outcomes:\n\nIt is anticipated that both SGLT2 and DPP-4 inhibitors will reduce the incidence and severity of doxorubicin-induced cardiotoxicity, with SGLT2 inhibitors expected to demonstrate superior cardioprotective efficacy. Findings from this study may support the integration of cardioprotective antidiabetic agents into oncology care pathways to improve the cardiac outcomes and overall survival of breast cancer patients.","conditions":["Breast Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy"},{"type":"DRUG","name":"Sitagliptin (DPP4 inhibitor)"},{"type":"OTHER","name":"Standard Care (in control arm)"}],"enrollment":150,"startDate":"2026-02-01","completionDate":"2027-11-01","sex":"FEMALE","minAge":null,"maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Female, ≥18 years, Egyptian nationality.\n2. Breast cancer (any stage) with planned anthracycline containing chemotherapy (intended cumulative DOX ≥240 mg/m² or epirubicin ≥360 mg/m² equivalents).\n3. Baseline echo suitable for LVEF ≥53%.\n4. Able to consent and comply with follow up.\n\nExclusion Criteria:\n\n* • Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation.\n\n  * Symptomatic HF, cardiomyopathy, significant valvular disease, prior anthracycline exposure.\n  * Baseline hypotension (SBP \\<95 mmHg), recurrent UTIs/mycotic infections, active foot ulcer/critical limb ischemia.\n  * Inflammatory diseases, liver and kidney diseases.\n  * Autoimmune diseases.\n  * Other type of malignancies or metastatic diseases.\n  * Patients who exposed to surgery less than one month.\n  * Concomitant dexrazoxane planned upfront (allowed only for rescue; documented).\n  * Known hypersensitivity to study drugs.","locations":[{"facility":"Tanta University","city":"Tanta","state":"Elgharbeya","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mai Aboelyazed Elgebaly, Associate Lecturer","phone":"+0201061412257","email":"dr.mai.elgebaly@gmail.com"},{"name":"Mai Aboelyazed Elgebaly, Associate Lecturer","phone":"+201115064114","email":"mai.elgebaly@deltauniv.edu.eg"}],"primaryOutcomes":["Percentage of participants experiencing cardiotoxicity"],"hasResults":false,"conditionSlugs":["breast-cancer","heart-failure"],"drugSlugs":["dapagliflozin"],"locationSlugs":["tanta-egypt"],"enrichment":{"headline":"Phase 4: testing Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy for Breast Cancer","inPlainEnglish":"Background: Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality. Anthracycline-based chemotherapy, particularly doxorubicin, remains a cornerstone of treatment; however, its clinical utility is limited by dose-dependent cardiotoxicity that can lead to irreversible cardiac dysfunction and heart failure.","whoItsFor":["Women only","Female, ≥18 years, Egyptian nationality","Breast cancer (any stage) with planned anthracycline containing chemotherapy (intended cumulative DOX ≥240 mg/m² or epirubicin ≥360 mg/m² equivalents)","Baseline echo suitable for LVEF ≥53%","Able to consent and comply with follow up"],"whoShouldSkip":["Type 1 and type 2 diabetes; history of diabetic ketoacidosis; pregnancy/lactation","Symptomatic HF, cardiomyopathy, significant valvular disease, prior anthracycline exposure","Baseline hypotension (SBP \\<95 mmHg), recurrent UTIs/mycotic infections, active foot ulcer/critical limb ischemia","Inflammatory diseases, liver and kidney diseases","Autoimmune diseases","Other type of malignancies or metastatic diseases","Patients who exposed to surgery less than one month"],"whatHappens":"If you join, the listed intervention(s) are Dapagliflozin (5-10 mg daily) - SGLT2 Inhibitor Therapy, Sitagliptin (DPP4 inhibitor), or Standard Care (in control arm). The registry lists allocation as randomized. Background: Breast cancer is the most frequently diagnosed malignancy among women worldwide and a major cause of morbidity and mortality.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 150 people at Tanta. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.962Z"},{"nctId":"NCT07437313","title":"Marine Lipids Ease Painful TMD","officialTitle":"Safety And Analgesic Efficacy of Marine Lipid Precursors of Specialized Pro-Resolving Mediators in Adults With Chronic Temporomandibular Pain","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of North Carolina, Chapel Hill","sponsorClass":"OTHER","summary":"The ADAPT study is a single-site, Phase 2b, randomized, quadruple-masked, placebo-controlled trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain. The trial will enroll 100 adults aged 18 years or older with examiner-confirmed TMD myalgia or arthralgia will be enrolled at the University of North Carolina at Chapel Hill, Adams School of Dentistry.\n\nParticipants are randomized 1:1 to receive either the SPM precursor supplement or a matched placebo daily for 8 weeks. Randomization is stratified by sex, and study agents are identical in appearance to maintain masking.\n\nThe study aims to evaluate whether the SPM precursor supplement:\n\nReduces facial pain intensity compared with placebo.\n\nChanges pressure pain sensitivity at the jaw and other standard body sites.\n\nAffects other aspects of chronic pain, including duration, interference with daily activities, headache burden, anxiety, depression, jaw-related quality of life, and overall patient-reported change.\n\nParticipants will record their daily facial pain intensity in paper diaries, complete short questionnaires at baseline, Week 4, and Week 8, and undergo experimental pain testing with a handheld algometer at baseline, Week 4, and Week 8. Safety is monitored through the documentation of all adverse events throughout the study period.","conditions":["Temporomandibular Disorder (TMD)"],"keywords":["Chronic facial pain","Temporomandibular joint pain","TMD myalgia","TMD arthralgia","Orofacial pain","Specialized pro-resolving mediators (SPMs)","Omega-3 fatty acids","Marine lipid supplement","Dietary supplement intervention","Pressure pain sensitivity","Experimental pain testing","Central sensitization","Chronic pain mechanisms","Randomized controlled trial","Pain interference","Headache impact","Anxiety and depression in chronic pain","Quality of life","Migraine","Body pain distribution"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"SPM Precursor-Enriched Marine Lipid Supplement"},{"type":"DIETARY_SUPPLEMENT","name":"Medium-Chain Triglyceride Supplement"}],"enrollment":100,"startDate":"2026-09-25","completionDate":"2030-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion\n\nPre-screening (before Visit 0):\n\n* Age ≥18 years.\n* Pain in jaws, temples, ears, or in front of ears at least 5 days in the past 30 days, occurring monthly over the last 3 months.\n* Pain not due to toothache or ear infection.\n* Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening.\n* Willing to provide written informed consent and follow all study procedures.\n* Able to be contacted reliably during the study period.\n\nVisit 0 - Screening/Baseline:\n\n* Meets all pre-screening criteria above.\n* Examiner-confirmed TMD diagnosis (myalgia or arthralgia) per DC-TMD criteria.\n* Discontinues omega-3 supplements prior to randomization and agrees not to use them during the study.\n* Will not initiate new occlusal splint therapy during the study. Participants already using a splint ≥30 days prior may continue.\n* Maintains stable facial pain management regimen:\n* No changes to regularly scheduled daily pain medications.\n* No initiation of new facial pain treatments (pharmacologic, injectable, or non-pharmacologic).\n* Episodic prescription pain medications discontinued prior to randomization, except NSAIDs, acetaminophen, or low-dose aspirin.\n\nVisit 1 - Randomization:\n\n* Completes ≥4 of 7 daily symptom diary (DSD) entries before Visit 1.\n* Average weekly pain ≥30 on 0-100 NRS, or ≥30 on at least 4 days that week.\n\nExclusion (Assessed at pre-screening and/or Visit 0):\n\n* Allergy or hypersensitivity to fish or seafood.\n* Botulinum toxin injections for facial pain within past 3 months.\n* Facial trauma or orofacial surgery within past 6 weeks.\n* History of renal failure or dialysis.\n* History of hyperthyroidism.\n* Immunocompromised state or autoimmune disorder.\n* History of seizure disorder or uncontrolled seizures.\n* Use of opioid medications in the past 30 days.\n* Pregnancy.","locations":[{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anne E Sanders, PhD","phone":"(919) 246-5833","email":"adaptsms@adapt.study"},{"name":"Lorraine M King","phone":"(919) 246-5833","email":"adaptsms@adapt.study"}],"primaryOutcomes":["Change in average weekly facial pain intensity","Rate of treatment-emergent adverse events"],"hasResults":false,"conditionSlugs":["migraine","depression"],"drugSlugs":[],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: SPM Precursor-Enriched Marine Lipid Supplement for Temporomandibular Disorder (TMD)","inPlainEnglish":"The ADAPT study is a single-site, Phase 2b, randomly assigned, quadruple-masked, compared with a dummy treatment trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain. The trial will enroll 100 adults aged 18 years or older with examiner-confirmed TMD myalgia or arthralgia will be enrolled at the University of North Carolina at Chapel Hill, Adams School of Dentistry.","whoItsFor":["Ages 18 Years to any","Pre-screening (before Visit 0):","Pain in jaws, temples, ears, or in front of ears at least 5 days in the past 30 days, occurring monthly over the last 3 months","Pain not due to toothache or ear infection","Pain intensity ≥30 on a 0-100 numeric rating scale (NRS) during the week before pre-screening","Able to be contacted reliably during the study period","Visit 0 - Screening/Baseline:","Meets all pre-screening criteria above"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are SPM Precursor-Enriched Marine Lipid Supplement, or Medium-Chain Triglyceride Supplement. The registry lists allocation as randomized. The ADAPT study is a single-site, Phase 2b, randomly assigned, quadruple-masked, compared with a dummy treatment trial evaluating an omega-3 dietary supplement enriched with specialized pro-resolving mediator (SPM) precursors in adults with chronic temporomandibular disorder (TMD) pain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Chapel Hill. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.292Z"},{"nctId":"NCT07437833","title":"Psychophysiological Responses to Six Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder","officialTitle":"Psychophysiological Responses to Six 15-Minute Single-Session Self-Regulation Interventions in a Female Adult With ADHD and Stabilized Bipolar Disorder: A Single-Case Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Poznan University of Physical Education","sponsorClass":"OTHER","summary":"This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include:\n\n* Aerobic exercise\n* Controlled breathing (cyclic sighing)\n* Aromatherapy with lavender essential oil\n* Listening to specific music (Solfeggio 528 Hz)\n* Virtual reality relaxation with forest imagery\n* Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.\n\nThe participant will attend one 15-minute session per week for each technique. Before and after each session, the researchers will measure:\n\n* Heart rate and heart rate variability\n* Stress levels using Subjective Units of Distress Scale\n* Mood using a questionnaire\n* Blood pressure\n* Brain activity using EEG\n* Memory performance with a simple test (N-back)\n* Pain sensitivity The goal is to understand how these short, non-invasive techniques influence both physiological and psychological responses. Sessions are safe, short, and designed to involve minimal risk. The findings may help guide future research on relaxation and exercise strategies for people with ADHD and bipolar disorder.","conditions":["ADHD - Attention Deficit Disorder With Hyperactivity","Bipolar Affective Disorder; Remission in"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Moderate-Intensity Aerobic Exercise on Cycloergometer"},{"type":"BEHAVIORAL","name":"Cyclic Sighing"},{"type":"BEHAVIORAL","name":"Aromatherapy"},{"type":"BEHAVIORAL","name":"Music Therapy"},{"type":"BEHAVIORAL","name":"Virtual Reality Nature Immersion"},{"type":"BEHAVIORAL","name":"Emotional Freedom Technique Tapping"},{"type":"BEHAVIORAL","name":"Resting State (Control Session)"}],"enrollment":1,"startDate":"2026-07-31","completionDate":"2027-04-30","sex":"FEMALE","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission.\n* No active depressive, manic, or psychotic episodes for at least 2 years.\n* No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years.\n* No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders).\n* Regular sleep-wake rhythm during the week preceding the study.\n* Non-smoker.\n* No night-shift work in the week preceding the study.\n\nExclusion Criteria:\n\n* Acute medical conditions that could affect study procedures.\n* Use of medications in the past 3 months that influence cardiovascular or neurological parameters.\n* Consumption of alcohol or psychoactive substances on the day before or day of the study.\n* Intense physical activity on the day before or day of the study.\n* Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions).\n* Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).","locations":[{"facility":"Poznan University of Physical Education","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Beata Jóźwiak","phone":"(61) 835 53 49","email":"b.jozwiak@awf.poznan.pl"}],"primaryOutcomes":["Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)","Heart Rate Variability (HRV)"],"hasResults":false,"conditionSlugs":["bipolar-disorder","adhd"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: Moderate-Intensity Aerobic Exercise on Cycloergometer for ADHD - Attention Deficit Disorder With Hyperactivity","inPlainEnglish":"This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder. The techniques being tested include: * Aerobic exercise * Controlled breathing (cyclic sighing) * Aromatherapy with lavender essential oil * Listening to specific music (Solfeggio 528 Hz) * Virtual reality relaxation with forest imagery * Emotional Freedom Technique (EFT) tapping One session of quiet sitting with eyes open serves as a comparison.","whoItsFor":["Ages 18 Years to 35 Years","Women only","Diagnosis of ADHD and bipolar disorder (type I or II) in stable remission","No active depressive, manic, or psychotic episodes for at least 2 years","No use of psychotropic medications, including mood stabilizers, antidepressants, antipsychotics, or ADHD medications, for at least 2 years","No chronic somatic diseases (including neurological, cardiovascular, or metabolic disorders)","Regular sleep-wake rhythm during the week preceding the study","No night-shift work in the week preceding the study"],"whoShouldSkip":["Acute medical conditions that could affect study procedures","Use of medications in the past 3 months that influence cardiovascular or neurological parameters","Consumption of alcohol or psychoactive substances on the day before or day of the study","Intense physical activity on the day before or day of the study","Contraindications to moderate-intensity exercise on a cycle ergometer (e.g., recent injuries, chronic musculoskeletal conditions)","Contraindications to EEG measurement (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes)"],"whatHappens":"If you join, the listed intervention(s) are Moderate-Intensity Aerobic Exercise on Cycloergometer, Cyclic Sighing, or Aromatherapy. The registry lists allocation as na. This study aims to explore how six short, 15-minute self-regulation techniques affect the body and brain in a female adult with ADHD and stabilized bipolar disorder.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1 people at Poznan. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.732Z"},{"nctId":"NCT07438496","title":"A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well nipocalimab works as compared to placebo in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).","conditions":["Lupus Erythematosus, Systemic"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nipocalimab"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care treatment"}],"enrollment":600,"startDate":"2026-03-05","completionDate":"2028-12-06","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:-\n\n* Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening\n* Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria\n* Must have a systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) score \\>= 6 and a clinical SLEDAI-2K \\>= 4 at screening, AND a clinical SLEDAI-2K score \\>= 4 points at Week 0. For eligibility, points attributed to \"lupus headache,\" \"alopecia,\" and \"organic brain syndrome\" are excluded\n* Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization\n* Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening\n\nExclusion Criteria:\n\n* History of severe, progressive and/or uncontrolled hepatic, gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension, and/or any other medical or uncontrolled autoimmune disorder (s) or clinically significant abnormalities in screening laboratory\n* Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications\n* Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant\n* Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins\n* Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the placebo formulation","locations":[{"facility":"David S Hallegua MD A Professional Corporation","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southland Arthritis and Osteoporosis Medical Center Inc dba Southland Arthritis","city":"Hemet","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Medical Research","city":"La Palma","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Mission Viejo","state":"California","country":"United 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3: testing Nipocalimab for Lupus Erythematosus, Systemic","inPlainEnglish":"This study wants to evaluate how well nipocalimab works as compared to dummy treatment (placebo) in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).","whoItsFor":["Ages 18 Years to 75 Years","Medically stable on the basis of physical examination, medical history, vital signs and 12-lead electrocardiogram (ECG) performed at screening","Clinical diagnosis of systemic lupus erythematosus (SLE) for more than or equal to (\\>=) 24 weeks prior to screening and meeting european league against rheumatism/american college of rheumatology (EULAR/ACR) classification criteria","Participants of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-hCG) test at screening and a negative urine (β- hCG) test at Week 0 prior to randomization","Has at least 1 BILAG-2004 A score or 2 BILAG-2004 B scores observed at screening"],"whoShouldSkip":["Any unstable or progressive manifestation of SLE that is likely to warrant escalation in therapy beyond permitted background medications","Confirmed or suspected clinical immunodeficiency syndrome not related to treatment of SLE or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant","Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis, to therapeutic proteins","Suspected or known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients, or excipients used in the dummy treatment (placebo) formulation"],"whatHappens":"If you join, the listed intervention(s) are Nipocalimab, Placebo, or Standard of care treatment. The registry lists allocation as randomized. This study wants to evaluate how well nipocalimab works as compared to dummy treatment (placebo) in participants with moderate to severe Systemic lupus erythematosus (SLE, a long-term disease where the immune system mistakenly attacks its own healthy tissues, causing swelling and redness in various organs).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 272 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.278Z"},{"nctId":"NCT07439484","title":"Individually Tailored, Supervised, Remote Exercise Intervention to Improve Physical Function for Stage I-III Gastroesophageal Cancer Survivors, PRECISE Trial","officialTitle":"A Pilot Study of an Individually Tailored, Supervised, Remotely Delivered Exercise Intervention to Improve Physical Function in Survivors of Gastroesophageal Cancer (PRECISE Study)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Jonsson Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This clinical trial tests an individually tailored, supervised, remote exercise intervention to improve physical function for stage I-III gastroesophageal cancer survivors. Modern treatments for gastroesophageal cancer are effective at treating the cancer but are often aggressive, can be difficult for patients to tolerate, and can lead to significant debilitation and a loss of independence. Exercise is one promising intervention that could improve physical function in patients with gastroesophageal cancer after finishing systemic treatment. Home based exercise interventions in patients with cancer during and after chemotherapy can improve fatigue and function. An individually tailored, supervised, remote exercise intervention may improve physical function for stage I-III gastroesophageal cancer survivors.","conditions":["Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8","Clinical Stage I Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage I Gastric Cancer AJCC v8","Clinical Stage I Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Adenocarcinoma AJCC v8","Clinical Stage II Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage II Gastric Cancer AJCC v8","Clinical Stage II Gastroesophageal Junction Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Adenocarcinoma AJCC v8","Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8","Clinical Stage III Gastric Cancer AJCC v8","Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8"],"keywords":[],"interventions":[{"type":"OTHER","name":"Actigraphy"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"OTHER","name":"Educational Intervention"},{"type":"OTHER","name":"Educational Intervention"},{"type":"OTHER","name":"Electronic Health Record Review"},{"type":"OTHER","name":"Exercise Intervention"},{"type":"OTHER","name":"Internet-Based Intervention"},{"type":"OTHER","name":"Physical Performance Testing"},{"type":"OTHER","name":"Survey Administration"}],"enrollment":20,"startDate":"2026-09-11","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥ 18 years old at the start of study treatment\n* Diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric cancer. Histology can be adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma\n* Treated with at least one systemic therapy (chemotherapy or immunotherapy) and within 12 months of completing curative intent gastroesophageal cancer (GEC) treatment\n* Have evidence of physical function impairment, defined as a SPPB score of \\< 12) at baseline\n* Ability to understand English and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients with stage I disease who underwent endoscopic resection or surgery alone without perioperative systemic therapy\n* Patients with stage IV disease or unresectable locally advanced disease taking a palliative treatment approach without a clearly defined end of treatment\n* Patients currently receiving ongoing systemic therapy for GEC or another malignancy\n* Patients who are unable to provide informed consent\n* Any other condition or pre-existing co-morbidity that would, in the Investigator's judgment, contraindicate the participation in the study due to safety concerns with study procedures\n* Currently participating in another exercise intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function","locations":[{"facility":"UCLA / Jonsson Comprehensive Cancer Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jingran Ji, MD","phone":"310-829-5471","email":"jingranji@mednet.ucla.edu"}],"primaryOutcomes":["Percentage of participants who attend at least 80% of the exercise sessions and complete the post-intervention functional assessment"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: Actigraphy for Clinical Stage I Esophageal Adenocarcinoma American Joint Committee on Cancer (AJCC) v8","inPlainEnglish":"This clinical trial tests an individually tailored, supervised, remote exercise intervention to improve physical function for stage I-III gastroesophageal cancer survivors. Modern treatments for gastroesophageal cancer are effective at treating the cancer but are often aggressive, can be difficult for patients to tolerate, and can lead to significant debilitation and a loss of independence.","whoItsFor":["Ages 18 Years to any","Adults ≥ 18 years old at the start of study treatment","Diagnosis of early-stage (Stage I, II, III) esophageal, gastroesophageal junction, or gastric cancer. Histology can be adenocarcinoma, squamous cell carcinoma, or poorly differentiated carcinoma","Treated with at least one systemic therapy (chemotherapy or immunotherapy) and within 12 months of completing curative intent gastroesophageal cancer (GEC) treatment","Have evidence of physical function impairment, defined as a SPPB score of \\< 12) at baseline"],"whoShouldSkip":["Patients with stage I disease who underwent endoscopic resection or surgery alone without perioperative systemic therapy","Patients with stage IV disease or unresectable locally advanced disease taking a palliative treatment approach without a clearly defined end of treatment","Patients currently receiving ongoing systemic therapy for GEC or another malignancy","Any other condition or pre-existing co-morbidity that would, in the Investigator's judgment, contraindicate the participation in the study due to safety concerns with study procedures","Currently participating in another exercise intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function"],"whatHappens":"If you join, the listed intervention(s) are Actigraphy, Biospecimen Collection, or Educational Intervention. The registry lists allocation as na. This clinical trial tests an individually tailored, supervised, remote exercise intervention to improve physical function for stage I-III gastroesophageal cancer survivors.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Los Angeles. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.978Z"},{"nctId":"NCT07441642","title":"A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration","officialTitle":"A Randomized, Double Masked, Placebo-controlled, Multicenter, Dose-range Finding Study to Assess the Efficacy and Safety of FWY003 in Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).","conditions":["Geographic Atrophy Secondary to Age-related Macular Degeneration"],"keywords":["FWY003","safety","tolerability","geographical atrophy"],"interventions":[{"type":"DRUG","name":"FWY003"},{"type":"DRUG","name":"Placebo"}],"enrollment":272,"startDate":"2026-03-09","completionDate":"2029-08-21","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nMale or female participants ≥ 50 years of age.\n\n* A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye.\n\n  1. Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)\n  2. If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2\n  3. Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy\n* ETDRS BCVA ≥ 35 letters (20/200) in the study eye.\n\nExclusion Criteria:\n\n* A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye.\n* Previous cell or gene therapy in either eye.\n* Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.\n* Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.\n* Presence of significant media opacity, eye movement disorder (nystagmus), severe ptosis, extraocular motility restriction or head tremor, which in the opinion of the investigator, would prevent adequate fundus visualization or which in the opinion of the Reading Center could interfere with the assessment of study images.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Salehi Retina Institute","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants Medical Group Inc","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Retina Consultants","city":"Santa Barbara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research LLC","city":"Boynton Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research LLC","city":"Deerfield Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Associates of Florida","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates New 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eye"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["huntington-beach-california","sacramento-california","santa-barbara-california","boynton-beach-florida","deerfield-beach-florida","st-petersburg-florida","metairie-louisiana","boston-massachusetts","toms-river-new-jersey","new-york-new-york","erie-pennsylvania","philadelphia-pennsylvania","bellaire-texas","houston-texas","katy-texas","rosario-argentina","caba-argentina","albury-australia","parramatta-australia","strathfield-australia","east-melbourne-australia","serra-brazil","blumenau-brazil","sofia-bulgaria","london-canada","ottawa-canada","shanghai-china","medell-n-colombia","barranquilla-colombia","prague-czechia","lyon-france","cr-teil-france","dijon-france","paris-france","ludwigshafen-germany","bonn-germany","m-nster-germany","t-bingen-germany","p-cs-hungary","debrecen-hungary","budapest-hungary","florence-italy","milan-italy","roma-italy","amagasaki-japan","kobe-japan","bunkyo-ku-japan","chiyoda-ku-japan","bydgoszcz-poland","krakow-poland","arecibo-puerto-rico","cluj-napoca-romania","bucharest-romania","santiago-compostela-spain","sant-cugat-del-v-spain","burjassot-spain","c-rdoba-spain","bristol-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 2: testing FWY003 for Geographic Atrophy Secondary to Age-related Macular Degeneration","inPlainEnglish":"To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).","whoItsFor":["Ages 50 Years to any","Male or female participants ≥ 50 years of age","A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye","Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)","If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2","Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy","ETDRS BCVA ≥ 35 letters (20/200) in the study eye"],"whoShouldSkip":["A history of, or current evidence of, choroidal neovascularization (exudative MNV) in the study eye","Previous cell or gene therapy in either eye","Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc","Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are FWY003, or Placebo. The registry lists allocation as randomized. To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 272 people at 63 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.138Z"},{"nctId":"NCT07444567","title":"Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit From Continued Treatment","officialTitle":"ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study With Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit From Continued Treatment","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term safety and tolerability of benralizumab.","conditions":["Asthma","Eosinophilic Granulomatosis With Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)"],"keywords":["Asthma","Eosinophilic Granulomatosis with Polyangiitis (EGPA)","Hypereosinophilic Syndrome (HES)"],"interventions":[{"type":"DRUG","name":"Benralizumab"}],"enrollment":230,"startDate":"2026-07-24","completionDate":"2029-12-27","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Provision of signed and dated written ICF.\n\n  2\\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment.\n* 3\\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment.\n* 4\\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment.\n* 5\\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation.\n\nExclusion Criteria:\n\n* 1\\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab.\n* 2\\. Participants who are planning to use live/live-attenuated vaccines.\n* 3\\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available.\n* 4\\. Participants with any medical condition (such as cancer or viral infections \\[hepatitis\\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.\n* 5\\. Concurrently enrolled in any clinical study (other than a parent study).\n* 6\\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period.\n* 7\\. Local access to commercially available benralizumab.","locations":[{"facility":"Research Site","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bethesda","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ann Arbor","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Northfield","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"The Bronx","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Durham","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research 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Site","city":"Ahmedabad","state":"","country":"India","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Ajmer","state":"","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Holon","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Petah Tikva","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Roma","state":"","country":"Italy","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Rotterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chęciny","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Gdansk","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lodz","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Incheon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Safety will be evaluated by monitoring and assessing SAEs and non-serious AEs reported throughout the study and until 8 weeks after the last dose of benralizumab"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["aurora-colorado","bethesda-maryland","ann-arbor-michigan","northfield-new-jersey","the-bronx-new-york","durham-north-carolina","cleveland-ohio","salt-lake-city-utah","buenos-aires-argentina","florida-argentina","lobos-argentina","mar-del-plata-argentina","mendoza-argentina","rosario-argentina","san-juan-bautista-argentina","innsbruck-austria","brussels-belgium","edegem-belgium","calgary-canada","hamilton-canada","toronto-canada","bron-france","marseille-france","montpellier-france","nantes-france","paris-france","pessac-france","suresnes-france","ahmedabad-india","ajmer-india","haifa-israel","holon-israel","petah-tikva-israel","roma-italy","rotterdam-netherlands","ch-ciny-poland","gdansk-poland","lodz-poland","incheon-south-korea","istanbul-turkey-t-rkiye","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Benralizumab for Asthma","inPlainEnglish":"The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term whether it is safe and how hard side effects are to live with of benralizumab.","whoItsFor":["Ages 6 Years to any","1\\. Provision of signed and dated written ICF","2\\. Participants completing minimum required OLE period of a parent study and judged by the Investigator to benefit from continued treatment","3\\. Participants must agree to follow the contraception requirements as per their respective parent protocols from study inclusion up to 12 weeks after the last dose of study treatment","4\\. Participants without childbearing potential at enrolment must agree to start appropriate contraception if childbearing potential develops during the study and up to 12 weeks after the last dose of study treatment","5\\. Participants who are unable to access commercially available benralizumab and clinically indicated for continuation"],"whoShouldSkip":["1\\. Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting benralizumab","2\\. Participants who are planning to use live/live-attenuated vaccines","3\\. Participants who are planning to use biologic therapies, including B-cell therapies with the exception for the treatment of co-morbidities where no alternative medicine is available","5\\. Concurrently enrolled in any clinical study (other than a parent study)","6\\. Participants who discontinued the parent study prior to completing the minimum OLE or treatment period","7\\. Local access to commercially available benralizumab"],"whatHappens":"If you join, the listed intervention(s) are Benralizumab. The registry lists allocation as randomized. The rationale of the roll-over study (ROSY) is to provide continuous access to study treatment for participants who have completed or exited a parent study and are deemed appropriate for continued benralizumab treatment, as judged by the Investigator, while monitoring long-term whether it is safe and how hard side effects are to live with of benralizumab.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 230 people at 41 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.340Z"},{"nctId":"NCT07447076","title":"Study of Novel Therapies for Young People With Recurrent/Progressive Atypical Teratoid Rhabdoid Tumor (ATRT)","officialTitle":"A Platform Study of Novel Therapies for Children, Adolescents and Young Adults With Recurrent/Progressive Atypical Teratoid Rhabdoid Tumor (ATRT)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sabine Mueller, MD, PhD","sponsorClass":"OTHER","summary":"This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and efficacy of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.","conditions":["Recurrent Atypical Teratoid/Rhabdoid Tumor","Atypical Teratoid/Rhabdoid Tumor (ATRT) of the CNS"],"keywords":["Novel therapies"],"interventions":[{"type":"PROCEDURE","name":"Lumber Puncture"},{"type":"PROCEDURE","name":"Blood Specimen Collection"},{"type":"PROCEDURE","name":"Magnetic resonance imaging (MRI)"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Paxalisib"},{"type":"PROCEDURE","name":"Tumor Biopsy"}],"enrollment":29,"startDate":"2026-06-17","completionDate":"2035-12-31","sex":"ALL","minAge":"1 Year","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* In addition to the below, investigators are to refer to arm-specific inclusion criteria in the appendix.\n\n  * Participants must have a pathologic diagnosis of central nervous system (CNS) ATRT, with confirmation of SWI/SNF-related, matrix-associated, actin-dependent regulator of chromatin, subfamily b, member 1 (SMARCB1) (INI1) loss by immunohistochemistry (IHC) and/or biallelic loss of function of SMARCB1 by molecular report. Loss of SWI/SNF Related, Matrix Associated, Actin Dependent Regulator of Chromatin, Subfamily A, Member 4 (SMARCA4) as confirmed by IHC or molecular report is also acceptable but requires study chair approval.\n  * Participants must have confirmation of methylation report, co-enrollment on PNOC-030 or sufficient tumor tissue available for methylation-based subgrouping\n  * Participants must have recurrent or progressive ATRT.\n  * Participants age must be ≥1 and ≤ 39 years at the time of study enrollment. Please refer to arm specific inclusion criteria for potential variations in lower age eligibility limit.\n  * Prior Therapy: Participants must have fully recovered from the acute effects of prior anti-cancer therapy, and the following wash-out periods need to be observed prior to enrollment:\n* Systemic myelosuppressive therapy: ≥ 21 days after the last dose (42 days for nitrosoureas or mitomycin C).\n* Intrathecal/intraventricular chemotherapy: \\> 7 days after the last dose.\n* Small molecule/targeted/biologic agent: ≥ 7 days after the last dose.\n* Monoclonal antibodies: ≥ 21 days after the last dose. Other non-myelosuppressive anti-cancer agents: ≥ 3 drug half-lives after the last dose.\n* CAR-T cell therapy (systemic or intraventricular): \\> 21 days.\n\n  • Previous radiotherapy. Participants will be eligible following radiotherapy, if they meet the following criteria:\n* Previous craniospinal or total body radiotherapy: Participants must have received their last fraction ≥ 12 weeks prior to enrollment and have evidence of progressive/recurrent evaluable disease post radiation.\n* Previous focal radiotherapy to target lesions: Participants must have received their last fraction to target lesions ≥12 weeks prior to enrollment and have evidence of progressive/recurrent evaluable disease post radiation; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression.\n* Focal radiotherapy to non-target lesions: Participants may have received radiotherapy to nontarget lesions as long as the last fraction was \\> 14 days prior to enrollment. Participants must have at least one non-irradiated lesion that is evaluable for response.\n\n  * Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n  * Corticosteroids: Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment. Please also refer to arm-specific inclusion criteria for potential variations in steroid limitations.\n  * Organ Function Requirements.\n\nAdequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 750/mm3\n* Platelet count ≥ 75,000/cubic millimeters (mm3) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n\nAdequate Renal Function Defined as:\n\n* Serum creatinine ≤ 1.5 Upper Limit Normal (ULN) based on age and gender\n\nAdequate Liver Function Defined as:\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \\< 3 x ULN or direct bilirubin \\< 1.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 3 x ULN\n* Aspartate aminotransferase (AST) ≤ 3 x ULN\n\nAdequate Neurologic Function Defined as:\n\n* Participants with seizure disorder may be enrolled if well controlled. See arm-specific recommendations for potential interactions between anticonvulsant agent(s) with study drug.\n\n  * Effect on the developing human fetus Recommendations on the potential effect of interventional agents on the developing human fetus will be specified in each study arm's details of therapeutic agents. Unless otherwise specified, the effects of study interventions should be considered potentially teratogenic. Thus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment and four months after its completion. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, or should a male participant's partners become pregnant during study participation, they should inform the treating physician immediately.\n  * A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n  * Participants must enroll on Pediatric Neuro-oncology Consortium (PNOC) COMP if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\n* Evidence of synchronous tumors or other extra-CNS malignancy\n* Participants who are receiving any other investigational agents\n* Participants who are currently receiving other anti-cancer agents\n* Participants with uncontrolled infection or other uncontrolled systemic illness\n* Female participants of childbearing potential who are pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy and throughout study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the intended treatment regimen, as detailed in that arm's treatment description.\n\nArm A\n\nInclusion Criteria:\n\n* Subjects must meet all inclusion criteria for the overall study.\n* Patients must be evaluable per Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria for medulloblastoma and other leptomeningeal seeding tumors to be evaluated for the primary endpoint (Warren et al. 2018); patients with evaluable but non-measurable disease, including leptomeningeal disease or positive CSF cytology only are eligible.\n\nPatients with recurrent or progressive ATRT who receive surgery only for their disease progression and do not have evaluable disease may be eligible for study treatment but would not be included towards the primary efficacy endpoint (to be discussed with study chairs).\n\n* Subjects must be able to swallow intact capsules.\n* Adequate Metabolic Function Defined as:\n\n  * Non-fasting glucose ≤ 140 milligrams per deciliter (mg/dL) without the use of antihyperglycemic agents.\n  * If non-fasting glucose \\> 140 mg/dL, a fasting glucose should be done. If fasting glucose ≤ 125 mg/dL without the use of antihyperglycemic agents, participant will meet adequate metabolic function criteria.\n  * Triglycerides of \\< 300 mg/dl and total cholesterol of \\< 300 mg/dl - can be on lipid lowering medications as needed to achieve.\n* Adequate Cardiac Function Defined as:\n\n  * Electrocardiogram (ECG) must be obtained to verify the Corrected QT Interval (QTC). If an abnormal reading is obtained, the ECG should be repeated in triplicate.\n  * QTC \\< 470 millisecond (msec)\n\nArm A\n\nExclusion Criteria:\n\nIn addition to not meeting any of the exclusion criteria of the overall study, participation on arm A will also require that subjects do not meet any of the following:\n\n* Previous exposure to gemcitabine or paxalisib\n* Concomitant use of an antihyperglycemic agent (e.g. metformin)\n* Chronic diarrhea greater than Grade 2","locations":[{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"John Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital University of Washington, Seattle","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"PNOC Operations Office","phone":"415-502-1600","email":"PNOC035@ucsf.edu"}],"primaryOutcomes":["Arm A (Phase I): Proportion of participants who experience dose-limiting toxicity (DLT)","Arm A (Phase I): Recommended Phase 2 Dose (RP2D) (Phase I)","Arm A (Phase II): Rate of Clinical Benefit"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["san-francisco-california","baltimore-maryland","seattle-washington"],"enrichment":{"headline":"Phase 2: testing Gemcitabine for Recurrent Atypical Teratoid/Rhabdoid Tumor","inPlainEnglish":"This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and how well it works of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.","whoItsFor":["Ages 1 Year to 39 Years","In addition to the below, investigators are to refer to arm-specific who can join in the appendix","Participants must have confirmation of methylation report, co-enrollment on PNOC-030 or sufficient tumor tissue available for methylation-based subgrouping","Participants must have recurrent or progressive ATRT","Participants age must be ≥1 and ≤ 39 years at the time of study enrollment. Please refer to arm specific who can join for potential variations in lower age eligibility limit","Prior Therapy: Participants must have fully recovered from the acute effects of prior anti-cancer therapy, and the following wash-out periods need to be observed prior to enrollment:","Systemic myelosuppressive therapy: ≥ 21 days after the last dose (42 days for nitrosoureas or mitomycin C)","Intrathecal/intraventricular chemotherapy: \\> 7 days after the last dose"],"whoShouldSkip":["Evidence of synchronous tumors or other extra-CNS malignancy","Participants who are receiving any other investigational agents","Participants who are currently receiving other anti-cancer agents","Participants with uncontrolled infection or other uncontrolled systemic illness","Female participants of childbearing potential who are pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy and throughout study treatment","History of allergic reactions attributed to compounds of similar chemical or biologic composition as the intended treatment regimen, as detailed in that arm's treatment description","who can join:"],"whatHappens":"If you join, the listed intervention(s) are Lumber Puncture, Blood Specimen Collection, or Magnetic resonance imaging (MRI). The registry lists allocation as randomized. This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and how well it works of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 29 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.567Z"},{"nctId":"NCT07449442","title":"SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty","officialTitle":"iPACK Block With Adductor Canal Block Mitigates Surgical Stress and Enhances Analgesia in Total Knee Arthroplasty: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.","conditions":["Knee Osteoarthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"sodium Chloride"},{"type":"DRUG","name":"Ropivacaine Hydrocloride"}],"enrollment":60,"startDate":"2026-03-01","completionDate":"2026-11-30","sex":"ALL","minAge":"65 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with ASA classification I-III\n* Aged 65-100 years\n* Who will be scheduled for hip arthroplasty under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who have a history of bleeding diathesis\n* Take anticoagulant therapy\n* History of chronic pain before surgery\n* Multiple trauma\n* patients unable to assess their pain (dementia)\n* patients operated under general anesthesia\n* patients having an infection in the region of the procedure\n* the patient who does not accept the procedure","locations":[{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Malgorzata Reysner, MD PhD","phone":"+48 501 056 924","email":"mreysner@ump.edu.pl"},{"name":"Malgorzata Reysner, MD PhD","phone":"+48 61 83 10 122","email":"mreysner@ump.edu.pl"}],"primaryOutcomes":["Systemic Inflammation Response Index (SIRI)"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: testing sodium Chloride for Knee Osteoarthritis","inPlainEnglish":"This randomly assigned controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response.","whoItsFor":["Ages 65 Years to 100 Years","Patients with ASA classification I-III","Who will be scheduled for hip arthroplasty under spinal anesthesia"],"whoShouldSkip":["Patients who have a history of bleeding diathesis","Take anticoagulant therapy","History of chronic pain before surgery","patients unable to assess their pain (dementia)","patients operated under general anesthesia","patients having an infection in the region of the procedure","the patient who does not accept the procedure"],"whatHappens":"If you join, the listed intervention(s) are sodium Chloride, or Ropivacaine Hydrocloride. The registry lists allocation as randomized. This randomly assigned controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Poznan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.515Z"},{"nctId":"NCT07449520","title":"Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)","officialTitle":"Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IHU Strasbourg","sponsorClass":"OTHER","summary":"EGO-Trial is the first multicenter study in France which aims to evaluate the efficacy of Endoscopic Sleeve Gastroplasty (ESG) in patients with obesity. This project fills a critical national gap by providing real-world, multicentric data from diverse French healthcare settings, offering insight into the safety, efficacy, and variability of ESG practices across institutions\n\nThe project is expected to generate robust, multicentric clinical evidence on the safety and efficacy of ESG in patients with obesity within the French healthcare context.","conditions":["Obesity"],"keywords":["Obesity","Endoscopic Sleeve Gastroplasty","Excess weight loss","Body Mass Index","Quality of Life"],"interventions":[{"type":"PROCEDURE","name":"Endoscopic sleeve gastroplasty"}],"enrollment":300,"startDate":"2026-03-17","completionDate":"2030-03","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 18 to 75 years.\n* Patients with a Body Mass Index (BMI) ≥ 30 kg/m².\n* Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy).\n* Patients not eligible for bariatric surgery or does not wish to undergo it.\n* Patients who can undergo general anesthesia.\n* Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study.\n* Patients who are able to fully understand the study and are willing to give their consent to participate in the study.\n* Patients affiliated with the French social security system.\n\nExclusion Criteria:\n\n* Patients with contraindications to endoscopic gastroplasty\n* Patients with active peptic ulcer disease or significant gastroparesis\n* Patients with a history of bariatric, gastric, or esophageal surgery.\n* Patients who have started medication in the last 3 months that is known to cause weight gain.\n* Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness.\n* Patients with unstable and precarious health, as determined and assessed by the investigator.\n* Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception.\n* Patients who are currently excluded (as determined by a previous or ongoing study).\n* Patients under judicial protection.\n* Patients under guardianship, conservatorship or subject to any form of protective supervision","locations":[{"facility":"Hôpital Privé de Provence","city":"Aix-en-Provence","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Polyclinique de Franche-Comté","city":"Besançon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clnique des Cèdres","city":"Échirolles","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital HURIEZ","city":"Lille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique de la Sauvegarde","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospices Civils de Lyon - Hôpital Edourard HERRIOT","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Clémentville","city":"Montpellier","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Mutualiste de l'Obésité","city":"Saint-Etienne","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHP Saint-Grégoire","city":"Saint-Grégoire","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Polyclinique Sainte Thérèse","city":"Sète","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique les Eaux Claires","city":"Baie-Mahault","state":"","country":"Guadeloupe","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Armelle TAKEDA","phone":"0033 390 413608","email":"armelle.takeda@ihu-strasbourg.eu"},{"name":"Clinical Research Team","phone":"","email":"rc-ihu@ihu-strasbourg.eu"}],"primaryOutcomes":["Total Body Weight Loss"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["aix-en-provence-france","besan-on-france","chirolles-france","lille-france","lyon-france","montpellier-france","saint-etienne-france","saint-gr-goire-france","s-te-france","strasbourg-france","baie-mahault-guadeloupe"],"enrichment":{"headline":"Not a traditional drug phase: Endoscopic sleeve gastroplasty for Obesity","inPlainEnglish":"EGO-Trial is the first multicenter study in France which aims to measure the how well it works of Endoscopic Sleeve Gastroplasty (ESG) in patients with obesity. This project fills a critical national gap by providing real-world, multicentric data from diverse French healthcare settings, offering insight into the safety, how well it works, and variability of ESG practices across institutions The project is expected to generate robust, multicentric clinical evidence on the safety and how well it works of ESG in patients with obesity within the French healthcare context.","whoItsFor":["Ages 18 Years to 75 Years","Patients aged 18 to 75 years","Patients with a Body Mass Index (body-mass index (BMI)) ≥ 30 kg/m²","Patients who have failed non-surgical weight loss interventions (diet, exercise, pharmacological therapy)","Patients not eligible for bariatric surgery or does not wish to undergo it","Patients who can undergo general anesthesia","Patients who are able to participate in all aspects of the study and agree to comply with all study requirements for the entire duration of the study","Patients who are able to fully understand the study and are willing to give their consent to participate in the study"],"whoShouldSkip":["Patients with contraindications to endoscopic gastroplasty","Patients with active peptic ulcer disease or significant gastroparesis","Patients with a history of bariatric, gastric, or esophageal surgery","Patients who have started medication in the last 3 months that is known to cause weight gain","Patients with a history of uncontrolled, poorly controlled, or suspected eating disorders or psychiatric illness","Patients with unstable and precarious health, as determined and assessed by the investigator","Patients who are pregnant, breastfeeding, or of childbearing age and not using effective contraception"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 12 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.837Z"},{"nctId":"NCT07449702","title":"An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis","officialTitle":"An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Oruka Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.","conditions":["Plaque Psoriasis"],"keywords":["Phase 2","ORKA-001","Open Label Extension","OLE"],"interventions":[{"type":"DRUG","name":"ORKA-001"}],"enrollment":240,"startDate":"2026-02-23","completionDate":"2030-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed informed consent by participants from previous trial choosing to transition into the OLE.\n2. Participants who have successfully completed the preceding trial.\n3. For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.\n4. For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception\n\nExclusion Criteria:\n\n1. Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001\n2. Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.\n3. Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.\n4. Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.\n5. Participant is pregnant or breastfeeding.","locations":[{"facility":"Oruka Therapeutics Investigative Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"North Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Cromwell","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Rolling Meadows","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Plainfield","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Bowling Green","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Mason","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Frisco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Webster","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Edmonton","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Fredericton","state":"New Brunswick","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Ajax","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"London","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Markham","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Peterborough","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Waterloo","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oruka Therapeutics Investigative Site","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Oruka Clinical Trials Information","phone":"781-560-0299","email":"clinicaltrials@orukatx.com"}],"primaryOutcomes":["Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs)"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","north-little-rock-arkansas","fountain-valley-california","los-angeles-california","san-diego-california","santa-ana-california","santa-monica-california","cromwell-connecticut","miami-florida","rolling-meadows-illinois","plainfield-indiana","bowling-green-kentucky","rockville-maryland","boston-massachusetts","detroit-michigan","new-york-new-york","cleveland-ohio","mason-ohio","portland-oregon","frisco-texas","houston-texas","webster-texas","norfolk-virginia","edmonton-canada","surrey-canada","fredericton-canada","ajax-canada","london-canada","markham-canada","peterborough-canada","toronto-canada","waterloo-canada","montreal-canada","qu-bec-canada"],"enrichment":{"headline":"Phase 2: testing ORKA-001 for Plaque Psoriasis","inPlainEnglish":"An open-label extension (OLE) study to measure the long-term safety and how well it works of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.","whoItsFor":["Ages 18 Years to any","Participants who have successfully completed the preceding trial","For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit","For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception"],"whoShouldSkip":["Participants who experienced any side effects with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001","Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial","Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data","Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001","Participant is pregnant or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are ORKA-001. The registry lists allocation as randomized. An open-label extension (OLE) study to measure the long-term safety and how well it works of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 240 people at 34 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.584Z"},{"nctId":"NCT07453602","title":"Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234","officialTitle":"A Phase 1a/1b, Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234 in Healthy Volunteers and Subjects With Moderate to Severe Atopic Dermatitis.","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Arcutis Biotherapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This is a first-in-human, Phase 1, double-blind, randomized, placebo-controlled, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD). Healthy volunteers will participate in Single Ascending Dose (SAD) Cohorts 1-5. Participants with moderate to severe AD will be enrolled in SAD Cohorts 6-7, Multiple Ascending Dose (MAD) Cohorts, and a Proof-of-Concept (POC) expansion cohort.","conditions":["Atopic Dermatitis (AD)","Eczema"],"keywords":["ARQ-234"],"interventions":[{"type":"BIOLOGICAL","name":"ARQ-234"},{"type":"DRUG","name":"Placebo"}],"enrollment":125,"startDate":"2026-03-02","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria (All Participants):\n\n* Able and willing to provide written informed consent.\n* Adults 18-65 years (inclusive) at consent.\n* Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator).\n* Contraception requirements: Females of childbearing potential: negative pregnancy tests at screening and baseline and agree to use highly effective contraception (plus barrier method) during the study and for 4 months after last dose. Males if sexually active with a pregnant partner or a female of childbearing potential, agree to condom use during the study and for 4 months after last dose.\n* Body weight by study part: Part A (SAD) \\& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)\n\nInclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):\n\n* Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening.\n* Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline.\n* Inadequate response, intolerance, or medical inappropriateness of topical AD therapies (and/or prior systemic AD therapy failure within the last year may qualify as inadequate response).\n\nExclusion Criteria (All Participants):\n\n* Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator).\n* Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions).\n* Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol).\n* History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics).\n* History of attempted suicide or significant current risk, per investigator).\n* Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB).\n* Known/suspected immunosuppression or history of invasive opportunistic infections or unusually frequent/recurrent/prolonged infections (per investigator).\n* Recent herpes zoster that poses risk or may affect interpretation (per investigator).\n* Malignancy within 5 years prior to screening\n* Positive urine drug screen at screening (Part A/Part B only) or drug/alcohol abuse within 12 months, or other condition likely to impair compliance (per investigator).\n* Unable to discontinue prohibited medications/treatments per protocol.\n* Major surgery within 4 weeks prior to baseline or planned during participation.\n* Participation in another trial or receipt of investigational product within 12 weeks (or 5 half-lives, whichever longer) before baseline.\n* Prior cell-depleting therapy (e.g., rituximab) within 6 months prior to baseline (or until lymphocytes normalize, whichever longer).\n* Blood products within 4 weeks prior to baseline or planned during participation.\n* Live (attenuated) vaccines within 28 days prior to baseline or planned during the study.\n* Pregnant or breastfeeding, or planning pregnancy during the study or within 4 months after last dose.\n* Known/suspected allergy to ARQ-234 or its excipients.\n* Unable to communicate/understand the local language or otherwise unsuitable per investigator.\n* Family member of study staff or sponsor.\n\nExclusion Criteria for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):\n\n* Skin disease(s) other than AD that would interfere with assessments.\n* Active systemic/local infection, including actively infected AD, or infection requiring oral/IV antimicrobials within 14 days before baseline.\n* Phototherapy/tanning bed use within 4 weeks prior to baseline.\n* Biologic therapy for AD within 3 months or 5 half-lives (whichever longer) prior to baseline.\n* Expected need for rescue therapy for AD within the first 2 weeks after baseline.\n* History of eczema herpeticum within 12 months or ≥2 prior episodes.","locations":[{"facility":"Clinical Site 112","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 110","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 106","city":"Plainfield","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 101","city":"Fair Lawn","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 102","city":"College Station","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 104","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site 109","city":"South Jordan","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arcutis Medical Information","phone":"1-844-692-6729","email":"medinfo@arcutis.com"}],"primaryOutcomes":["Number and percentage of participants who experience an adverse event (AE) or serious adverse event (SAE)","Percent change from Baseline in the Eczema Area and Severity Index (EASI) score, a validated measure of disease severity in atopic dermatitis."],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["miami-florida","plainfield-indiana","fair-lawn-new-jersey","college-station-texas","san-antonio-texas","south-jordan-utah"],"enrichment":{"headline":"Phase 1: testing ARQ-234 for Atopic Dermatitis (AD)","inPlainEnglish":"This is a first-in-human, Phase 1, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, dose-escalation study evaluating ARQ-234. The study is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ARQ-234 in two populations: healthy volunteers and participants with moderate to severe atopic dermatitis (AD).","whoItsFor":["Ages 18 Years to 65 Years","(All Participants):","Adults 18-65 years (inclusive) at consent","Generally healthy at screening/baseline (no clinically significant findings on medical history, exam, vitals, ECG, or safety labs, per investigator)","Body weight by study part: Part A (SAD) \\& Part B (MAD): 50-100 kg (inclusive), Part C (POC): 50-125 kg (inclusive)","who can join for atopic dermatitis (AD) Participants (Parts A Cohorts 6-7, Part B, Part C):","Diagnosis of moderate-to-severe atopic dermatitis for ≥ 6 months prior to screening","Meets minimum disease severity at baseline: Part A Cohorts 6-7: BSA ≥7%, vIGA-AD 3-4, EASI ≥10 at Baseline, Parts B and C: BSA ≥10%, vIGA-AD 3-4, EASI ≥16 at Baseline"],"whoShouldSkip":["(All Participants):","Any clinically significant medical or psychiatric condition that could increase risk, interfere with participation, or confound results (per investigator)","Significant renal impairment or clinically significant hepatic impairment (per protocol/part-specific definitions)","Clinically significant cytopenias or clinically significant abnormal liver tests at screening (per protocol)","History of anaphylaxis/serious hypersensitivity (including significant hypersensitivity to local anesthetics)","History of attempted suicide or significant current risk, per investigator)","Chronic or significant infection history or positive screening tests for hepatitis B, hepatitis C, HIV, or tuberculosis (including positive QuantiFERON or history of active/latent TB)"],"whatHappens":"If you join, the listed intervention(s) are ARQ-234, or Placebo. The registry lists allocation as randomized. This is a first-in-human, Phase 1, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, dose-escalation study evaluating ARQ-234.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 125 people at 7 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.833Z"},{"nctId":"NCT07454733","title":"Do Video Recordings of Multidisciplinary Clinics Improve Quality of Life for People With ALS and Their Caregivers?","officialTitle":"Comparing the Impact of Video Integration to Traditional Amyotrophic Lateral Sclerosis Visit Communication on Patient and Caregiver Quality of Life","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Trustees of Dartmouth College","sponsorClass":"OTHER","summary":"Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. The gold standard of care for people with ALS is multidisciplinary clinics (MDC). In these multidisciplinary clinics, which occur every 3 to 4 months, people with ALS see up to 12 different healthcare providers (e.g., speech therapy, physical therapy, the ALS doctor). These clinics can last from three to five hours, and across these three to five hours people with ALS and their caregivers receive a lot of information that is critical to the care and quality of life for people with ALS. However, this information can be difficult to remember given the large amount of information that is conveyed. The current standard for providing take-home information about the visit is to provide patients with a written after-visit summary and access to their doctor's notes about the visit, typically through the patient portal. This study tests whether providing participants with video recordings of their MDC visits improves their quality of life and the quality of life of their caregivers. The study will enroll 400 pairs of people with ALS and their caregivers from eight different sites in the United States. Half of the participants in the study will receive their after-visit summary notes (the NOTES condition) and the other half of the participants will receive both their summary notes, but will also receive video recordings of their MDC visits that they can watch on their own at home (the VIDEO condition). The study will last for 12 months, with participants receiving NOTES or VIDEO at each of their regularly-scheduled MDCs during the 12 months. The study will test whether caregiver and patient participants in the VIDEO condition experience better quality of life than those in the NOTES condition at 1 month, 6 months, and 12 months from study enrollment. The results of this study will help determine what is the most effective approach to communicating MDC information to people with ALS and their caregivers.","conditions":["Amyotrophic Lateral Sclerosis (ALS)"],"keywords":["amyotrophic lateral sclerosis (ALS)","Open Notes","Open Recordings","video recording","after-visit summaries"],"interventions":[{"type":"BEHAVIORAL","name":"Video recording"},{"type":"BEHAVIORAL","name":"Notes Instruction"}],"enrollment":800,"startDate":"2026-08-12","completionDate":"2029-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for People with ALS:\n\n* Diagnosis of ALS by either El- Escorial or Gold Coast Criteria\n* ≥18 years of age\n* Plan to attend MDC visits for 12 months\n* Speak English or Spanish\n* Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial\n* Projected life expectancy of at least 12 months as determined by the site investigator.\n\nExclusion Criteria for People with ALS:\n\n* Unable or unwilling to provide informed consent or follow study procedures\n* Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator\n* Current pregnancy based on participant self-report;\n* Unable to access the internet;\n* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;\n* Do not wish to create a patient portal account, if they do not already have one;\n* Uncorrected hearing or visual impairment that would impair the ability to view video recordings;\n* Incarcerated.\n\nInclusion Criteria for Caregivers:\n\n* Agree to their identified role as a caregiver of a patient with ALS participating in the VITALS trial;\n* Speak English or Spanish;\n* ≥18 years of age.\n\nExclusion Criteria for Caregivers:\n\n* Unable or unwilling to provide consent or follow study procedures;\n* Unable to access the internet;\n* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;\n* Uncorrected hearing or visual impairment;\n* Professional caregiver for the patient;\n* Incarcerated.","locations":[{"facility":"Mayo Clinic Scottsdale","city":"Scottsdale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dartmouth-Hitchcock Health","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn State Health Milton S. Hersey Medical Center","city":"Hershey","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Wisconsin Health","city":"Madison","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paul J Barr, PhD","phone":"603-646-7016","email":"paul.j.barr@dartmouth.edu"},{"name":"Kelly M Goedert, PhD","phone":"603-646-6976","email":"kelly.m.goedert@dartmouth.edu"}],"primaryOutcomes":["For Caregiver Participants: the total score on the PROMIS-10 self report survey","For Patient Participants: The total score on the ALSAQ-40 self report survey."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","jacksonville-florida","boston-massachusetts","lebanon-new-hampshire","hershey-pennsylvania","pittsburgh-pennsylvania","madison-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: Video recording for Amyotrophic Lateral Sclerosis (ALS)","inPlainEnglish":"Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States. The gold standard of care for people with ALS is multidisciplinary clinics (MDC).","whoItsFor":["Ages 18 Years to any","for People with ALS:","Diagnosis of ALS by either El- Escorial or Gold Coast Criteria","Plan to attend MDC visits for 12 months","Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial","Projected life expectancy of at least 12 months as determined by the site investigator"],"whoShouldSkip":["for People with ALS:","Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator","Current pregnancy based on participant self-report;","Unable to access the internet;","Do not have access to a personal or shared email and are not interested in creating a personal or shared email;","Do not wish to create a patient portal account, if they do not already have one;","Uncorrected hearing or visual impairment that would impair the ability to view video recordings;"],"whatHappens":"If you join, the listed intervention(s) are Video recording, or Notes Instruction. The registry lists allocation as randomized. Amyotrophic lateral sclerosis (ALS) is a fatal, rare neurodegenerative disease affecting 30,000 people in the United States.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 800 people at 7 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.611Z"},{"nctId":"NCT07455851","title":"A Trial to Study if REGN17372 in Combination With Linvoseltamab is Tolerable for Adult Participants With Relapsed/Refractory Multiple Myeloma","officialTitle":"A FIH Phase 1/2 Study to Assess Safety, Tolerability, and Preliminary Anti-Tumor Activity of REGN17372, an Anti-GPRC5D x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Linvoseltamab, an Anti-BCMA x Anti-CD3 Bispecific Monoclonal Antibody, in Participants With Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.\n\nThe aim of the study is to understand if REGN17372 can be given safely with linvoseltamab, and if so, what dosing regimen should be used for this treatment combination, in comparison with linvoseltamab alone.\n\nThe study is looking at:\n\n* What side effects may happen from taking REGN17372 with linvoseltamab\n* How well REGN17372 and linvoseltamab, or linvoseltamab alone, work in treating multiple myeloma\n* What is the best dose of REGN17372 when given with linvoseltamab\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)\n* If and how REGN17372 and linvoseltamab affect the overall quality of life, daily activities, symptoms and treatment side effects based on participant own feedback (Phase 2)","conditions":["Relapsed Refractory Multiple Myeloma (RRMM)"],"keywords":["B-cell maturation antigen (BCMA)","Anti-CD3 monoclonal antibodies (mAbs)","G-protein-coupled receptor class C group 5 member D (GPRC5D)"],"interventions":[{"type":"DRUG","name":"Linvoseltamab"},{"type":"DRUG","name":"REGN17372+Linvoseltamab"}],"enrollment":150,"startDate":"2026-03-26","completionDate":"2033-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol\n2. ECOG performance status score ≤1\n3. Participants must have measurable disease for response assessment as described in the protocol\n4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol\n2. Participants who have known MM brain lesions or CNS involvement\n3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening\n4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)\n\nNote: Other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"South Western Sydney Local Health District - Liverpool Hosptial","city":"Liverpool","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital","city":"Randwick","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illawarra Cancer care centre, Wollongong Hospital","city":"Wollongong","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Vincents Hospital Melbourne","city":"Fitzroy","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alfred Hospital","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelismos General Hospital","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"1st Health Region of Athens, Alexandra General Hospital of Athens","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Occurrence of Dose Limiting Toxicities (DLTs) from the first dose of REGN17372 in combination with linvoseltamab","Occurrence of Treatment Emergent Adverse Events (TEAEs) associated with REGN17372 in combination with linvoseltamab","Severity of TEAEs associated with REGN17372 in combination with linvoseltamab","Very Good Partial Response (VGPR) or better as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria in patients receiving combination study drugs","VGPR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy","Partial Response (PR) or better as determined by the investigator using the IMWG response criteria in patients receiving combination study drugs","PR or better as determined by the investigator using the IMWG response criteria in patients receiving Linvoseltamab monotherapy"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["liverpool-australia","randwick-australia","wollongong-australia","adelaide-australia","fitzroy-australia","melbourne-australia","athens-greece"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Linvoseltamab for Relapsed Refractory Multiple Myeloma (RRMM)","inPlainEnglish":"This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma. This study is the first time REGN17372 will be given to humans.","whoItsFor":["Ages 18 Years to any","Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol","how well you can do daily activities (ECOG score) score ≤1","Participants must have measurable disease for response assessment as described in the protocol","Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol"],"whoShouldSkip":["Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol","Participants who have known MM brain lesions or CNS involvement","Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening","Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)","Note: Other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Linvoseltamab, or REGN17372+Linvoseltamab. The registry lists allocation as randomized. This study is researching a drug called REGN17372 used with another drug called linvoseltamab (each individually called \"study drug\" or \"study drugs\" when combined) in participants with relapsed (when a tumor comes back) or refractory (when a tumor does not respond to treatment) multiple myeloma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.497Z"},{"nctId":"NCT07457580","title":"Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","officialTitle":"A Real-World Retrospective Observational Study Characterizing Patients With Stage 2 Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.","conditions":["Type 1 Diabetes"],"keywords":[],"interventions":[{"type":"DRUG","name":"Teplizumab"}],"enrollment":60,"startDate":"2026-03-16","completionDate":"2026-11-30","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient written or electronic informed consent or assent (for patients \\< 18 years old) according to local regulations or appropriate informed consent waivers prior to any study related activity.\n* Patient received ≥ 1 day of teplizumab treatment as part of MAPs.\n\nExclusion Criteria:\n\n• Participation in an interventional clinical study on the index date. Participation in an interventional clinical study is defined as initiating the product/procedure or control under investigation. An interventional clinical study is a study that requires deviation from standard clinical practice by following a study protocol.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number: 0560001","city":"Leuven","state":"","country":"Belgium","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500001","city":"Bron","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500003","city":"Paris","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2500002","city":"Paris","state":"","country":"France","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760003","city":"Augsburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760002","city":"Frankfurt","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760001","city":"Hanover","state":"","country":"Germany","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 2760004","city":"Munich","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 3800001","city":"Ancona","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 3800003","city":"Palermo","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 3800002","city":"Verona","state":"","country":"Italy","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 7240001","city":"Madrid","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 7240002","city":"Madrid","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 7240003","city":"Zaragoza","state":"","country":"Spain","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260001","city":"Birmingham","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null},{"facility":"Investigational Site Number: 8260002","city":"London","state":"","country":"United Kingdom","status":"COMPLETED","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"contact-us@sanofi.com"}],"primaryOutcomes":["Participant demographics at teplizumab initiation","Participants' family history of T1D and autoimmune diseases","Presence of T1D susceptibility genes","Presence of T1D susceptibility genes","Participants' medical history"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["leuven-belgium","bron-france","paris-france","augsburg-germany","frankfurt-germany","hanover-germany","munich-germany","ancona-italy","palermo-italy","verona-italy","madrid-spain","zaragoza-spain","birmingham-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Teplizumab for Type 1 Diabetes","inPlainEnglish":"This study is a multi-country, multi-center retrospective watch-and-measure (no experimental treatment required) cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.","whoItsFor":["Patient received ≥ 1 day of teplizumab treatment as part of MAPs"],"whoShouldSkip":["The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.518Z"},{"nctId":"NCT07458100","title":"The STEP-MIED Trial: Digital Stepped-Care for Emotional Disorders","officialTitle":"Effectiveness and Cost-effectiveness of a Digital Stepped-care Mindfulness Intervention for Recovery From Emotional Disorders: a Multicentre Pragmatic Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Peking University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are:\n\n* Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years?\n* Is this combined approach more cost-effective than usual care alone? Researchers will compare the group receiving the digital mindfulness intervention plus their usual treatment to the group receiving only their usual treatment to see if the intervention leads to better long-term recovery and represents good value for money.\n\nParticipants in the intervention group will:\n\n* Attend eight weekly 2-hour online group mindfulness sessions.\n* Use a WeChat mini-program for 49 days of guided mindfulness exercises and daily tasks.\n* Patients who have not achieved reliable recovery after group retraining voluntarily participate in individual UP\\&MIED counseling.\n* Complete regular questionnaires and interviews over two years to track their progress.\n\nAll participants will continue to receive their usual medical care from their doctors throughout the study.","conditions":["Emotional Disorders","Depressive Disorder","Anxiety Disorders","Obsessive-Compulsive Disorder","Post-Traumatic Stress Disorder, PTSD","Eating Disorders"],"keywords":["Cost-effectiveness","Mindfulness","Recovery","randomized controlled trial","stepped-care","Emotional Disorders"],"interventions":[{"type":"BEHAVIORAL","name":"Mindfulness Intervention for Emotional Distress"}],"enrollment":600,"startDate":"2026-03-23","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age: 18-65 years.\n2. Diagnosed with an emotional disorder by a outpatient psychiatrist, including depressive disorders, anxiety disorders (e.g., generalized anxiety disorder, panic disorder, agoraphobia, social anxiety disorder), obsessive-compulsive disorder, post-traumatic stress disorder, and eating disorders (e.g., anorexia nervosa, bulimia nervosa).\n3. Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8.\n\nExclusion Criteria:\n\n1. Current diagnosis of psychotic disorders or bipolar disorder.\n2. Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders.\n3. Current suicide risk (PHQ-9 item 9 score \\>2).\n4. Antisocial personality disorder.\n5. Severe medical illnesses that may affect intervention participation or require recent hospitalization.\n6. Previous participation in a systematic 8-week mindfulness course.\n7. Inability to access the internet.","locations":[{"facility":"Peking University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dongyang Chen","phone":"+8618810673387","email":"psychen@stu.pku.edu.cn"},{"name":"Elena Gomzyakova","phone":"+8618665380155","email":"lenagom@stu.pku.edu.cn"}],"primaryOutcomes":["Time to Reliable Recovery"],"hasResults":false,"conditionSlugs":["depression","ptsd","anxiety"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Mindfulness Intervention for Emotional Distress for Emotional Disorders","inPlainEnglish":"The goal of this clinical trial is to measure the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety. The main questions it aims to answer are: * Does adding a digital mindfulness intervention to usual care help people recover from emotional disorders faster and more sustainably over two years?","whoItsFor":["Ages 18 Years to 65 Years","Symptom severity meeting the threshold: PHQ-9 score ≥10 or GAD-7 score ≥8"],"whoShouldSkip":["Current diagnosis of psychotic disorders or bipolar disorder","Current organic mental disorders, pervasive developmental disorders, severe cognitive impairment, or substance use disorders","Current suicide risk (PHQ-9 item 9 score \\>2)","Antisocial personality disorder","Severe medical illnesses that may affect intervention participation or require recent hospitalization","Previous participation in a systematic 8-week mindfulness course","Inability to access the internet"],"whatHappens":"If you join, the listed intervention(s) are Mindfulness Intervention for Emotional Distress. The registry lists allocation as randomized. The goal of this clinical trial is to measure the effectiveness and cost-effectiveness of a digital mindfulness-based intervention in adults (aged 18-65) diagnosed with emotional disorders like depression or anxiety.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 600 people at Beijing. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.406Z"},{"nctId":"NCT07458217","title":"Combined CM and STN Stimulation for Motor Epilepsy","officialTitle":"Combined CM and STN Stimulation for Motor Epilepsy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Boston Scientific Corporation","sponsorClass":"INDUSTRY","summary":"This self-crossover, randomized controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.","conditions":["Motor Epilepsy"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Deep brain stimulation"}],"enrollment":10,"startDate":"2026-10-13","completionDate":"2028-05-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\) 18-65 Years.\n* 2\\) Drug Resistant Epilepsy.\n* 3\\) Motor Epilepsy - defined as:\n\n  1. Epilepsy diagnosis meeting ILAE criteria\n  2. Motor Epilepsy defined as including one or more of:\n\n  i. Tonic, Clonic, or Tonic-Clonic activity; ii. Myoclonic Jerks; iii.Epileptic Spasms; iv.Focal Motor Seizures (identified primary lesion will be in motor functional area, such as primary motor cortex (BA4), pre-motor cortex (BA6), Central Posterior Gyrus (BA1-3), or other motor region); v.Motor activity not secondary to non-motor seizure. c.Clinical or Electrographic corroboration of at least one of: i.Video-EEG confirmation of motor seizure semiology; ii.Interictal or ictal EEG findings consistent with epileptic motor network involvement; iii.Consistent clinical description by trained cliniciants.\n* 4\\) \\>3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days.\n* 5\\) Subject or caregiver is able to provide epileptic seizure record within 90 days prior to the surgery.\n* 6\\) Voluntarily participate in the trial, sign the informed consent form, and be willing to comply with study requirements, including follow-ups.\n\nExclusion Criteria:\n\n* 1\\) Non Motor Epilepsy.\n* 2\\) Previous diagnosis of psychogenic/non-epileptic seizures.\n* 3\\) Brain lesion resection or ablation surgery performed less than 6 months.\n* 4\\) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device.\n* 5\\) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential).","locations":[{"facility":"Xuanwu Hospital Capital Medical Univers","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Mean change in seizure frequency","Adverse events related to DBS implantation"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Deep brain stimulation for Motor Epilepsy","inPlainEnglish":"This self-crossover, randomly assigned controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.","whoItsFor":["Ages 18 Years to 65 Years","2\\) Drug Resistant Epilepsy","3\\) Motor Epilepsy - defined as:","Epilepsy diagnosis meeting ILAE criteria","Motor Epilepsy defined as including one or more of:","4\\) \\>3 Focal or Generalized seizures / month with an inter-seizure interval no great than 30 days"],"whoShouldSkip":["1\\) Non Motor Epilepsy","2\\) Previous diagnosis of psychogenic/non-epileptic seizures","3\\) Brain lesion resection or ablation surgery performed less than 6 months","4\\) Implanted Vagus nerve stimulation (VNS) or responsive neurostimulation (RNS) devices recommended neither stimulation off the device at least 6 months nor remove the device","5\\) Pregnant, breastfeeding, or having the intention to become pregnant during the study period (for females of childbearing potential)"],"whatHappens":"If you join, the listed intervention(s) are Deep brain stimulation. The registry lists allocation as randomized. This self-crossover, randomly assigned controlled, pilot study aims to collect clinical data of bilateral stimulation of subthalamic nucleus (STN) combined with centromedian (CM) thalamus deep brain stimulation (DBS) for drug resistant epilepsy with motor symptom in adults.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Beijing. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.910Z"},{"nctId":"NCT07459101","title":"UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4","officialTitle":"UNIty-Based MR-Linac Guided Adaptive RadioThErapy for High GraDe Glioma-4 (UNITED-4): Prospective Evaluation of FLAIR-Guided Clinical Target Volume Reduction","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sunnybrook Health Sciences Centre","sponsorClass":"OTHER","summary":"This study builds on the results of prior studies (UNITED and UNITED-3). The goal of UNITED-4 is to test whether an adaptive radiation therapy (RT) therapy approach ('dose painting'), with reduced margins, impacts approach in participants with glioblastoma impacts local control compared to standard non-adaptive RT approach. The main questions of the study are to see how this adaptive RT approach with reduced margins compares to standard RT in terms of:\n\n* Local control\n* Overall and progression-free survival\n* Patterns of failure\n* Toxicity, Neurological Function, and Quality of Life\n* Longitudinal imaging features","conditions":["Glioblastoma (GBM)","Astrocytoma, Grade IV"],"keywords":[],"interventions":[{"type":"RADIATION","name":"Dose painting + Reduced Margins"}],"enrollment":120,"startDate":"2025-09-10","completionDate":"2029-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma (IDH wild type or mutant)\n* Deemed clinically appropriate for concurrent chemoradiotherapy (with temozolomide) with definitive/radical intent\n* Biopsy or surgical resection performed ≤ 12 weeks prior to study entry\n* Expected survival ≥ 12 weeks\n* ECOG performance status of 0, 1 or 2\n* Sufficient estimated glomerular filtration rate (eGFR) of ≥ 30 mL/ min/1.73 m2 to allow administration of gadolinium-based contrast agent; patients with eGFR \\< 30 mL/min/1.73 m2 not on dialysis may be allowed on the study after discussion of risks and benefits and approval by study neuroradiologist(s)\n* Completed written informed consent\n* Patient must be accessible for treatment and follow-up\n* Patients with multifocal or multicentric disease will be allowed per the discretion of the radiation oncologist\n\nExclusion Criteria:\n\n* Contraindications to MRI examination as per standard MRI screening policy\n* Contraindication to Gadolinium-based contrast media\n* Enhancing disease involving any part of the brainstem on post-gadolinium T1-weighted MRI imaging for patients being treated using the short-course 15-fraction regimen\n* Inability to lie flat in a supine position for at least 30 minutes\n* Inability to tolerate immobilization in a head thermoplastic mask\n* Patients \\> 140 kg and/or a circumference \\> 60 cm (MRI scanner weight and bore size limits)\n* Prior therapeutic cranial irradiation\n* Leptomeningeal dissemination of disease\n* History of other malignancies with the exception of adequately treated non-melanoma skin cancer, or curatively treated other solid tumours with no evidence of disease for ≥ 2 years\n* Patients with any condition (e.g. psychological, geographical, etc.) that does not permit compliance with the protocol","locations":[{"facility":"Sunnybrook Health Sciences Centre - Odette Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hanbo Chen, MD","phone":"416-480-6100","email":"hanbo.chen@sunnybrook.ca"}],"primaryOutcomes":["Disease worsening at 6 months"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: Dose painting + Reduced Margins for Glioblastoma (GBM)","inPlainEnglish":"This study builds on the results of prior studies (UNITED and UNITED-3). The goal of UNITED-4 is to test whether an adaptive radiation therapy (RT) therapy approach ('dose painting'), with reduced margins, impacts approach in participants with glioblastoma impacts local control compared to standard non-adaptive RT approach.","whoItsFor":["Ages 18 Years to any","Histopathologically confirmed, based on biopsy or surgical resection, glioblastoma or WHO grade 4 astrocytoma (IDH wild type or mutant)","Deemed clinically appropriate for concurrent chemoradiotherapy (with temozolomide) with definitive/radical intent","Biopsy or surgical resection performed ≤ 12 weeks prior to study entry","Expected survival ≥ 12 weeks","how well you can do daily activities (ECOG score) of 0, 1 or 2","Patient must be accessible for treatment and follow-up","Patients with multifocal or multicentric disease will be allowed per the discretion of the radiation oncologist"],"whoShouldSkip":["Contraindications to MRI examination as per standard MRI screening policy","Contraindication to Gadolinium-based contrast media","Enhancing disease involving any part of the brainstem on post-gadolinium T1-weighted MRI imaging for patients being treated using the short-course 15-fraction regimen","Inability to lie flat in a supine position for at least 30 minutes","Inability to tolerate immobilization in a head thermoplastic mask","Patients \\> 140 kg and/or a circumference \\> 60 cm (MRI scanner weight and bore size limits)","Prior therapeutic cranial irradiation"],"whatHappens":"If you join, the listed intervention(s) are Dose painting + Reduced Margins. The registry lists allocation as na. This study builds on the results of prior studies (UNITED and UNITED-3).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Toronto. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.489Z"},{"nctId":"NCT07459296","title":"Becotatug Vedotin Plus Sintilimab in Locoregionally Advanced NPC","officialTitle":"Becotatug Vedotin Combined With Sintilimab and Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma：A Multicenter, Randomized, Controlled, Phase 3 Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"First Affiliated Hospital of Guangxi Medical University","sponsorClass":"OTHER","summary":"This study is a multicenter, randomized, controlled phase III clinical trial aiming to investigate the efficacy and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), adverse events, and quality of life.","conditions":["Nasopharyngeal Carcinoma (NPC)"],"keywords":["Nasopharyngeal Carcinoma","Becotatug Vedotin","Sintilimab","Concurrent Chemoradiotherapy"],"interventions":[{"type":"DRUG","name":"Becotatug Vedotin"},{"type":"DRUG","name":"Sintilimab"},{"type":"DRUG","name":"Cisplatin"},{"type":"RADIATION","name":"intensity-modulated radiotherapy"},{"type":"DRUG","name":"Gemcitabine (GEM)"},{"type":"DRUG","name":"Cisplatin"}],"enrollment":266,"startDate":"2026-09-08","completionDate":"2030-04-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form in writing.\n2. Aged 18-70 years, male or non-pregnant female.\n3. Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III).\n4. Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis.\n5. ECOG performance status score of 0-1.\n6. Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L.\n7. Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN.\n8. Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula).\n9. Sexually active females of childbearing potential must agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug. Males who have sexual relations with females of childbearing potential must also agree to use effective contraceptive measures during treatment and for 1 year after the last administration of the study drug.\n\nExclusion Criteria:\n\n1. Aged \\> 70 years or \\< 18 years.\n2. Patients with recurrent or distant metastatic nasopharyngeal carcinoma.\n3. Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I).\n4. Patients who have previously received radiotherapy or systemic chemotherapy.\n5. Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\> 1000 copies/mL or 200 IU/mL.\n6. Positive for hepatitis C virus antibody (anti-HCV).\n7. Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).\n8. Patients who received systemic glucocorticoids (equivalent to prednisone \\> 10 mg/day) or other immunosuppressive therapy within 28 days prior to signing the informed consent form. Patients who received systemic glucocorticoids equivalent to prednisone ≤ 10 mg/day, inhaled or topical glucocorticoids are eligible for enrollment.\n9. Patients with a history of active tuberculosis within the past year; patients with active tuberculosis that has been adequately treated for more than one year are eligible for enrollment. Patients with a history of other malignant tumors (except cured basal cell carcinoma or carcinoma in situ of the cervix).\n10. Patients with a history of interstitial lung disease.\n11. Patients who received live vaccines within 30 days prior to signing the informed consent form or plan to receive live vaccines in the near future.\n12. Pregnant or lactating females.\n13. Patients with a history of other malignant tumors within the past 5 years, except carcinoma in situ, adequately treated non-melanoma skin cancer, and papillary thyroid cancer.\n14. Patients with known hypersensitivity to any component of gemcitabine, cisplatin, becotatug vedotin, or sintilimab.\n15. Patients with known history of HIV infection.\n16. Any other conditions deemed by the investigator to potentially affect the patient's ability to sign the informed consent form, cooperate with and participate in the study, or interfere with the interpretation of results, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illnesses, or family/social factors.","locations":[{"facility":"The First Affiliated Hospital of Guangxi Medical University","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Min Kang, MD","phone":"+86-771-5356509","email":"kangmin@gxmu.edu.cn"}],"primaryOutcomes":["Event-free survival (EFS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["nanning-china"],"enrichment":{"headline":"Phase 3: testing Becotatug Vedotin for Nasopharyngeal Carcinoma (NPC)","inPlainEnglish":"This study is a multicenter, randomly assigned, controlled phase III clinical trial aiming to investigate the how well it works and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC). The study plans to enroll 266 patients with high-risk NPC (AJCC 9th edition, anyT N2-3M0 or T4N1M0), who will be randomly assigned to the experimental group or the control group at a 1:1 ratio.The primary endpoint is 3-year event-free survival (EFS), and the secondary endpoints include overall survival (OS), local-regional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), objective response rate (ORR), side effects, and quality of life.","whoItsFor":["Ages 18 Years to 70 Years","Aged 18-70 years, male or non-pregnant female","Pathologically confirmed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or III)","Staged as anyT N2-3 or T4N1 (9th AJCC/UICC staging) without distant metastasis","how well you can do daily activities (ECOG score) score of 0-1","Hemoglobin (HGB) ≥ 90 g/L, neutrophil count ≥ 1.5×10⁹/L, and platelet (PLT) count ≥ 100×10⁹/L","Liver function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), and total bilirubin ≤ 1.5 times ULN","Normal renal function: Creatinine clearance rate ≥ 60 ml/min (calculated using the Cockcroft-Gault formula)"],"whoShouldSkip":["Aged \\> 70 years or \\< 18 years","Patients with recurrent or distant metastatic nasopharyngeal carcinoma","Pathologically confirmed as keratinizing squamous cell carcinoma (WHO type I)","Patients who have previously received radiotherapy or systemic chemotherapy","Positive for hepatitis B surface antigen (HBsAg) with hepatitis B virus DNA \\> 1000 copies/mL or 200 IU/mL","Positive for hepatitis C virus antibody (anti-HCV)","Patients with active autoimmune diseases, excluding type 1 diabetes mellitus, hypothyroidism controlled by replacement therapy, and skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, or alopecia)"],"whatHappens":"If you join, the listed intervention(s) are Becotatug Vedotin, Sintilimab, or Cisplatin. The registry lists allocation as randomized. This study is a multicenter, randomly assigned, controlled phase III clinical trial aiming to investigate the how well it works and safety of Becotatug Vedotin induction therapy followed by concurrent chemoradiotherapy (CCRT) combined with neoadjuvant and adjuvant sintilimab, versus gemcitabine plus cisplatin (GP) induction chemotherapy followed by CCRT, in the treatment of high-risk locally advanced nasopharyngeal carcinoma (LANPC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 266 people at Nanning. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.335Z"},{"nctId":"NCT07460739","title":"Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis","officialTitle":"Efficacy of a Self-Management Smartphone App in Promoting Safety Skills of Patients With Inflammatory Arthritis Treated by Anti-Rheumatic Drugs","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"Rheumatoid arthritis (RA) and spondyloarthritis (SpA), including psoriatic arthritis (PsA), are chronic painful diseases that impair quality of life. Disease-modifying antirheumatic drugs (DMARDs) are used to control disease activity, reduce functional disability, and improve prognosis. These include conventional DMARDs such as methotrexate, as well as targeted DMARDs (tDMARDs), i.e., biological agents (bDMARDs) like anti-TNF alpha and JAK inhibitors. Patients treated with tDMARDs face a risk of adverse effects, including an increased risk of infections. Therapeutic patient education has been shown to help patients develop safety skills, but its effectiveness is only short-term.\n\nMobile health applications are increasingly used by patients to manage their health.\n\nThe French Society of Rheumatology (SFR) has developed a smartphone self-management application aimed at supporting people with inflammatory arthritis in managing their treatments, symptoms, and information needs. It provides advice on lifestyle and daily living, promotes treatment adherence, and enables self-assessment of disease status. The app includes seven features: a safety checklist before treatment administration, daily life aids based on French academic recommendations, treatment reminders, self-assessment of overall well-being, disease monitoring (pain, fatigue, patient global assessment of disease activity), periodic advisory messages, and a diary.\n\nThe application is not a medical device; collected data are stored on the user's smartphone. Patient data are not directly shared with physicians. Patients can use the app during consultations or share screenshots with their doctors. The app is more widely used and has a longer lifespan than most available apps, but its impact on patients still needs evaluation in a randomized controlled trial.\n\nThe primary hypothesis of the study is that using the app will improve safety skills in patients with inflammatory arthritis treated with tDMARDs compared to usual care, including access to the SFR patient information website.\n\nThe secondary hypothesis is that using the app will improve patient adherence and the patient-rheumatologist relationship.\n\nObjectives : To determine whether the mobile application improves patients' ability to acquire safety-related skills in the daily use of targeted disease-modifying antirheumatic drugs (tDMARDs), compared to usual care, including access to an informational website for patients.\n\nThe primary outcome will be the change in the BioSecure questionnaire score at 6 months after inclusion, comparing the group using the mobile application with the group using the informational website.","conditions":["Rhumatoid Arthisis","Spondyloarthritis (SA)","Psoriatic Arthritis (PsA)"],"keywords":["Rhumatoid Arthisis","spondyloarthritis","Psoriatic Arthritis","Mobile Application"],"interventions":[{"type":"DEVICE","name":"SFR application"}],"enrollment":144,"startDate":"2026-08-31","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Diagnosis of rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria of the American College of Rheumatology, or axial or peripheral spondyloarthritis (SpA) according to the 2009 ASAS criteria of the Assessment of SpondyloArthritis International Society, or psoriatic arthritis according to the 2009 CASPAR criteria.\n* Undergoing a treatment change to a tDMARD (biologic or JAK inhibitor) available in the SFR application.\n* No therapeutic education on tDMARDs in the past two years.\n* Ability to use a smartphone application.\n* Ability to use a website.\n* Ability to complete a questionnaire.\n* Signed informed consent for the study.\n* Covered by social security or entitled to social protection.\n\nExclusion Criteria:\n\n* Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment).\n* Planned treatment with intravenous bDMARDs in the upcoming year.\n* Patients who have already downloaded self-management applications for their rheumatic disease.\n* Patients enrolled in a therapeutic education program: face-to-face education by a nurse or healthcare professional, or group education.\n* Patients who have already received therapeutic education on targeted DMARDs in the past two years: face-to-face education by a nurse or healthcare professional, or group education.\n* Participation in another interventional clinical trial\n* Pregnant or breast-feeding woman\n* Individual under legal protection (tutorship or guardianship) or deprived of freedom","locations":[{"facility":"Rheumatology Hopital Saint Antoine","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Catherine BEAUVAIS, Medical Doctor","phone":"+33149282520","email":"catherine.beauvais@aphp.fr"}],"primaryOutcomes":["safety skills regarding the use of tDMARDS"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: SFR application for Rhumatoid Arthisis","inPlainEnglish":"Rheumatoid arthritis (RA) and spondyloarthritis (SpA), including psoriatic arthritis (PsA), are chronic painful diseases that impair quality of life. Disease-modifying antirheumatic drugs (DMARDs) are used to control disease activity, reduce functional disability, and improve prognosis.","whoItsFor":["Ages 18 Years to 75 Years","Age between 18 and 75 years","Undergoing a treatment change to a tDMARD (biologic or JAK inhibitor) available in the SFR application","No therapeutic education on tDMARDs in the past two years","Ability to use a smartphone application","Ability to use a website","Ability to complete a questionnaire","Covered by social security or entitled to social protection"],"whoShouldSkip":["Any condition that may affect comprehension or treatment adherence (chronic alcoholism, language barrier, severe psychiatric disorders, cognitive impairment)","Planned treatment with intravenous bDMARDs in the upcoming year","Patients who have already downloaded self-management applications for their rheumatic disease","Patients enrolled in a therapeutic education program: face-to-face education by a nurse or healthcare professional, or group education","Patients who have already received therapeutic education on targeted DMARDs in the past two years: face-to-face education by a nurse or healthcare professional, or group education","Participation in another treatment clinical trial","Pregnant or breast-feeding woman"],"whatHappens":"If you join, the listed intervention(s) are SFR application. The registry lists allocation as randomized. Rheumatoid arthritis (RA) and spondyloarthritis (SpA), including psoriatic arthritis (PsA), are chronic painful diseases that impair quality of life.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 144 people at Paris. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.573Z"},{"nctId":"NCT07461441","title":"Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy","officialTitle":"Efficacy and Durability of a Personalized Treat-and-extend Regimen of Faricimab for Treatment-naive Polypoidal Choroidal Vasculopathy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Yeungnam University College of Medicine","sponsorClass":"OTHER","summary":"To evaluate the Efficacy of a personalized treat-and-extend regimen of faricimab for treatment-naive polypoidal choroidal vasculopathy","conditions":["Polypoidal Choroidal Vasculopathy (PCV)","Age Related Macular Degeneration"],"keywords":["Polypoidal Choroidal Vasculopathy (PCV)","Faricimab","Age-related macular degeneration"],"interventions":[{"type":"DRUG","name":"Faricimab Injection [Vabysmo]"}],"enrollment":50,"startDate":"2026-03-01","completionDate":"2028-11-30","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPotential participants are eligible to be included in the study only if all of the following criteria apply:\n\n\\[Ocular Conditions\\]\n\n* Presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy, i.e., exudative or hemorrhagic features involving the macula on color fundus photography (CFP), FA and spectral domain optical coherence tomography (SD-OCT) AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT.\n* BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline.\n* Greatest liner dimension (GLD) of the total lesion area (branching vascular network \\[BVN\\] + polypoidal lesion) \\< 5400 μm (equivalent to 9 macular photocoagulation study \\[MPS\\] Disc Area) as delineated by ICGA.\n\n\\[Systemic Conditions\\]\n\n* Signed Informed Consent Form\n* Age ≥ 50 years at the time of signing Informed Consent Form\n* Participants who are able to comply with the study protocol, in the investigator's judgment\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)\n\nExclusion Criteria:\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n\\[Ocular Conditions\\] in the Study Eye\n\n* Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline.\n* Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline.\n* Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline.\n* Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1\n* Concomitant conditions or ocular disorders in the study eye at Screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period.\n* Presence of subfoveal geographic atrophy or extensive retinal pigment epithelial atrophy involving the central subfield that, in the opinion of the investigator, may limit visual potential.\n* Presence of subfoveal fibrosis or scarring involving the central subfield as identified on color fundus photography or OCT.\n* Presence of subretinal or sub-RPE hemorrhage involving ≥50% of the total lesion area, or any hemorrhage obscuring the fovea.\n* Any active intraocular or periocular infection or active intraocular inflammation (IOI) in study eye or fellow eye at Screening or Baseline.\n* Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) \\> 25 mmHg on medication, or according to Investigator's judgment, at Screening or Baseline.\n* Any PCV masquerades like macular aneurysms, macular telangiectasia, etc. in study eye.\n\nAdd these EC fro both eyes\n\nPotential participants are excluded from the study if any of the following criteria apply:\n\n* History of idiopathic or autoimmune-associated uveitis in either eye\n* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1 \\[Systemic Conditions\\]\n\n  * Systemic anti-VEGF therapy any time prior to Baseline.\n  * Any major illness or major surgical procedure within 1 month before screening\n  * Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of \\< 6 (Grade Group of 1) and a stable prostate-specific antigen for \\>12 months\n  * Continuous use of any medications and treatments (which will be indicated in the Prohibited Therapy section in protocol)\n  * Systemic treatment for suspected or active systemic infection on study Day 1\n  * Uncontrolled blood pressure, defined as systolic blood pressure \\> 180 mmHg and/or diastolic blood pressure \\> 100 mmHg while the participant is at rest on study Day 1\n  * History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1\n  * History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator\n  * History of severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injection, study-related procedure preparations (including fluorescein and indocyanine green dyes), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study\n  * Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab","locations":[{"facility":"Yeungnam university medical center","city":"Daegu","state":"Namgu","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (LV)"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":["faricimab"],"locationSlugs":["daegu-south-korea"],"enrichment":{"headline":"Phase 3: testing Faricimab Injection [Vabysmo] for Polypoidal Choroidal Vasculopathy (PCV)","inPlainEnglish":"To measure the how well it works of a personalized treat-and-extend regimen of faricimab for treatment-who have not tried this kind of treatment before polypoidal choroidal vasculopathy","whoItsFor":["Ages 50 Years to any","Potential participants are eligible to be included in the study only if all of the following criteria apply:","\\[Ocular Conditions\\]","BCVA score must be ≤ 78 and ≥ 24 letters at 4 meters starting distance using early treatment diabetic retinopathy study (ETDRS) visual acuity charts at both Screening and Baseline","Greatest liner dimension (GLD) of the total lesion area (branching vascular network \\[BVN\\] + polypoidal lesion) \\< 5400 μm (equivalent to 9 macular photocoagulation study \\[MPS\\] Disc Area) as delineated by ICGA","\\[Systemic Conditions\\]","Participants who are able to comply with the study protocol, in the investigator's judgment","For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception (will be defined in details in protocol)"],"whoShouldSkip":["Potential participants are excluded from the study if any of the following criteria apply:","\\[Ocular Conditions\\] in the Study Eye","Previous treatment with any anti-VEGF drugs or faricimab or investigational drugs at any time prior to Baseline","Previous use of intraocular or periocular steroids within the 6-month period prior to Baseline","Macular laser photocoagulation (focal/grid) or PDT at any time prior to Baseline and peripheral laser photocoagulation within 3 months prior to Baseline","Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1","Presence of subfoveal geographic atrophy or extensive retinal pigment epithelial atrophy involving the central subfield that, in the opinion of the investigator, may limit visual potential"],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. To measure the how well it works of a personalized treat-and-extend regimen of faricimab for treatment-who have not tried this kind of treatment before polypoidal choroidal vasculopathy","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 50 people at Daegu. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.133Z"},{"nctId":"NCT07462221","title":"Effect of Telenursing on Oral Health","officialTitle":"The Effect of Telenursing Interventions on Oral Health in Individuals With COPD","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Çanakkale Onsekiz Mart University","sponsorClass":"OTHER","summary":"This research will be conducted using a pre-test and post-test control group experimental design to evaluate the effect of telenursing intervention on oral health in individuals with COPD.","conditions":["COPD"],"keywords":["oral health","tele-nursing","COPD"],"interventions":[{"type":"BEHAVIORAL","name":"telenursing"},{"type":"BEHAVIORAL","name":"reminders"}],"enrollment":80,"startDate":"2026-03-04","completionDate":"2026-03-04","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have been diagnosed with COPD for at least 6 months,\n* receive inpatient treatment in internal medicine and surgical clinics,\n* signed the informed consent form to participate in the study,\n* have internet access and a mobile device with Android/iOS operating system,\n* be able to use a phone,\n* ≥ 40 years old,\n* have no communication barriers,\n* mild (Stage 1), moderate (Stage 2), severe (Stage 3), or very severe (Stage 4) stages according to the GOLD (2023) report.\n\nExclusion Criteria:\n\n* Those diagnosed with COPD less than 6 months ago,\n* Those receiving outpatient treatment,\n* Those hospitalized in the intensive care unit,\n* Those without internet access and a mobile device with Android/iOS operating system,\n* Those who do not have the ability to use a phone,\n* Those under 40 years of age,\n* Those with communication barriers,\n* Those who wish to withdraw from the research/withdraw from participation during the research process,","locations":[{"facility":"Department of Nursing, Faculty of Health Sciences, Canakkale Onsekiz Mart University","city":"Çanakkale","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"SEVDA ATEŞ, Associate Professor","phone":"0905536088072","email":"sevdaefil@comu.edu.tr"},{"name":"SEVDA TUREN, Associate Professor","phone":"0905432208074","email":"sevdamercanhm@hotmail.com"}],"primaryOutcomes":["oral healt","Quality of Life Related to Oral Health"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["anakkale-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: telenursing for COPD","inPlainEnglish":"This research will be conducted using a pre-test and post-test control group experimental design to measure the effect of telenursing intervention on oral health in individuals with COPD.","whoItsFor":["Ages 40 Years to any","Participants must have been diagnosed with COPD for at least 6 months,","receive inpatient treatment in internal medicine and surgical clinics,","have internet access and a mobile device with Android/iOS operating system,","be able to use a phone,","have no communication barriers,","mild (Stage 1), moderate (Stage 2), severe (Stage 3), or very severe (Stage 4) stages according to the GOLD (2023) report"],"whoShouldSkip":["Those diagnosed with COPD less than 6 months ago,","Those receiving outpatient treatment,","Those hospitalized in the intensive care unit,","Those without internet access and a mobile device with Android/iOS operating system,","Those who do not have the ability to use a phone,","Those under 40 years of age,","Those with communication barriers,"],"whatHappens":"If you join, the listed intervention(s) are telenursing, or reminders. The registry lists allocation as randomized. This research will be conducted using a pre-test and post-test control group experimental design to measure the effect of telenursing intervention on oral health in individuals with COPD.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Çanakkale. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.647Z"},{"nctId":"NCT07463846","title":"A Study to Evaluate ALN-2232 in Participants With Obesity","officialTitle":"A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Alnylam Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to:\n\n* evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity\n* evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity\n* evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity","conditions":["Obesity"],"keywords":["siRNA, RNAi therepeutic"],"interventions":[{"type":"DRUG","name":"ALN-2232"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Tirzepatide"}],"enrollment":156,"startDate":"2026-03-02","completionDate":"2027-04-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAll Parts:\n\n* Has a body mass index (BMI) of ≥30 kg/m\\^2 and \\<40 kg/m\\^2\n* Has a hemoglobin A1c (HbA1c) \\<6.5%\n\nExclusion Criteria:\n\nAll Parts:\n\n* Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results\n* Receiving therapies for chronic weight management or antidiabetic medications\n\nNote: other protocol defined inclusion/exclusion criteria apply","locations":[{"facility":"Clinical Trial Site","city":"Mount Royal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alnylam Clinical Trial Information Line","phone":"1-877-ALNYLAM","email":"clinicaltrials@alnylam.com"},{"name":"Alnylam Clinical Trial Information Line","phone":"1-877-256-9526","email":"clinicaltrials@alnylam.com"}],"primaryOutcomes":["Part A: Frequency of Adverse Events (AEs)","Part B: Percent Change from Baseline in Body Weight","Part C: Percent Change from Baseline in Body Weight"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["mount-royal-canada"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ALN-2232 for Obesity","inPlainEnglish":"This study wants to: * measure the safety, tolerability, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity","whoItsFor":["Ages 18 Years to 65 Years","Has a body mass index (body-mass index (BMI)) of ≥30 kg/m\\^2 and \\<40 kg/m\\^2","Has a hemoglobin A1c (HbA1c) \\<6.5%"],"whoShouldSkip":["Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results","Receiving therapies for chronic weight management or antidiabetic medications","Note: other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ALN-2232, Placebo, or Tirzepatide. The registry lists allocation as randomized. This study wants to: * measure the safety, tolerability, how well it works, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 in patients with obesity * measure the safety, tolerability, how well it works, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 156 people at Mount Royal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.030Z"},{"nctId":"NCT07464925","title":"A Phase 1 Safety and Dose Finding Study of GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","officialTitle":"An Open-Label Phase 1 Safety and Dose Finding Study of Orally Administered GLIX1 in Adults With Recurrent or Progressive High-grade Glioma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Tetragon Biosciences Ltd","sponsorClass":"INDUSTRY","summary":"This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as monotherapy by reviewing safety and tolerability, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.\n\nPatients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.","conditions":["Glioblastoma Multiforme of Brain","Glioma","Glioblastoma"],"keywords":["GLIX1","Glioma","GBM","Glioblastoma","TET2"],"interventions":[{"type":"DRUG","name":"GLIX1"}],"enrollment":30,"startDate":"2026-04-20","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Main Inclusion Criteria:\n\n* Adult patients aged ≥18 years at the time of informed consent\n* Participants must have histologically confirmed Grade 3 or Grade 4 glioma\n* Recurrent or progressive disease\n* A maximum of two prior treatment lines\n* Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field.\n* Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:\n\n  * for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)\n  * for monoclonal antibodies: 42 days (6 weeks)\n  * for small molecules, 4 weeks or at least 5 half-lives (whatever is longer)\n* Recovered from all toxicities from prior treatments to Grade 1 or less by NCI CTCAE v6.0:\n* Participants receiving corticosteroids must be on a stable or decreasing dose of ≤6 mg daily dexamethasone (or ≤40 mg prednisone) for the 7 days prior to the start of study treatment.\n* Participants with seizures must be adequately controlled on a stable regimen of anti-epileptic drugs.\n* Adequate performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.\n* Ability to swallow tablets or capsules.\n* Adequate hematological, liver and renal function.\n* Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to first dosing. Women must use a highly effective form of contraception (with Pearl Index \\<1%) for the duration of the study and for at least 3 months after the last dose of study medication.\n* Men with partners of childbearing potential must be willing to use condoms in combination with a second effective method of contraception by the partner during the study and for at least 3 months after the last dose of study medication.\n\nMain Exclusion Criteria:\n\n* Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI\n* Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and/or bisphosphonates or denosumab.\n* Participants with known active or uncontrolled infection, and/or unexplained fever \\>38°C in the 3 days prior to the start of study treatment.\n* Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent.\n* Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI.","locations":[{"facility":"Stanford University","city":"Palo Alto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Safety Profile of GLIX1 (%Participants with Treatment-emergent Adverse Events)","Maximal Tolerated Dose and/or Recommended Dose"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["palo-alto-california","tampa-florida","chicago-illinois","new-york-new-york"],"enrichment":{"headline":"Phase 1: testing GLIX1 for Glioblastoma Multiforme of Brain","inPlainEnglish":"This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as this drug alone by reviewing whether it is safe and how hard side effects are to live with, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated. Patients will be treated daily with GLIX1 capsules until disease progression or unacceptable safety.","whoItsFor":["Ages 18 Years to any","Participants must have histologically confirmed Grade 3 or Grade 4 glioma","Recurrent or progressive disease","A maximum of two prior treatment lines","Interval of at least 3 months since the last day off of radiotherapy, unless tumor progression and index lesion is outside the prior radiation field","Interval since last dose of systemic therapy and Baseline MRI of ≥28 days, except:","for nitrosoureas (e.g., lomustine, carmustine, fotemustine): 42 days (6 weeks)","for monoclonal antibodies: 42 days (6 weeks)"],"whoShouldSkip":["Known contraindication for gadolinium (Gd) based, contrast-enhanced MRI","Prior history of another invasive malignancy unless a complete remission was achieved at least 3 years prior to enrolment AND no additional therapy is required during the study period, except for anti-estrogen or androgen therapy and/or bisphosphonates or denosumab","Participants with known active or uncontrolled infection, and/or unexplained fever \\>38°C in the 3 days prior to the start of study treatment","Major non-tumor related surgical procedure or significant traumatic injury within 28 days prior to signing of consent","Receiving any investigational products (defined as treatment for which there is currently no regulatory authority-approved indication) within 4 weeks or 5 half-lives (whichever is the longest) prior to Baseline MRI"],"whatHappens":"If you join, the listed intervention(s) are GLIX1. The registry lists allocation as na. This is an open-label, multicenter dose-escalation study to be followed by a dose expansion to define the optimal dose of GLIX1 as this drug alone by reviewing whether it is safe and how hard side effects are to live with, disease characteristics and pharmacokinetic profiles and preliminary clinical activity in participants with a high grade diffuse glioma that progressed during or recurred after prior standard of care therapies or investigational therapies as clinically indicated.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.479Z"},{"nctId":"NCT07466550","title":"A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants","officialTitle":"A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.","conditions":["Healthy Volunteer"],"keywords":["Healthy Volunteer","Risankizumab"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Risankizumab"}],"enrollment":60,"startDate":"2026-06-04","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.\n* BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.\n* Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.","locations":[{"facility":"CenExel ACT- Anaheim Clinical Trials /ID# 281821","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cpmi /Id# 281783","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Number of Participants with Adverse Events (AEs)","Maximum Observed Serum Concentration (Cmax) of Risankizumab","Time to Cmax (Tmax) of Risankizumab","Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["risankizumab"],"locationSlugs":["anaheim-california","miami-florida"],"enrichment":{"headline":"Phase 1: testing Risankizumab for Healthy Volunteer","inPlainEnglish":"This study wants to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.","whoItsFor":["Ages 18 Years to 65 Years","Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement","body-mass index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. body-mass index (BMI) is calculated as weight in kg divided by the square of height measured in meters","A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG"],"whoShouldSkip":["Exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening","Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab, or Risankizumab. The registry lists allocation as randomized. This study wants to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.581Z"},{"nctId":"NCT07467018","title":"Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County","officialTitle":"Mobile Vehicle-Based Delivery of Lenacapavir Pre-Exposure Prophylaxis in Los Angeles County (MOVE-LA)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of California, Los Angeles","sponsorClass":"OTHER","summary":"This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings. In 2022, approximately 13% of newly diagnosed HIV cases in LAC were experiencing homelessness, a 36% increase over the prior period. The study will work with the University of California, Los Angeles (UCLA) Health's Homeless Healthcare Collaborative (HHC), which operates mobile health vans staffed by clinicians, social workers, and community health workers, to bring LEN PrEP directly to community settings, such as shelters, encampments, community centers, and transitional housing facilities.\n\nThis study has three primary aims:\n\n1. Characterize uptake of LEN PrEP among unstably housed people in LAC receiving health services via HHC's mobile program.\n2. Evaluate how many study participants stay on LEN PrEP through 52 weeks.\n3. Understand costs, acceptability, and sustainability of the mobile LEN PrEP delivery model.","conditions":["HIV Prevention"],"keywords":["lenacapavir","community-based health delivery","HIV prevention","homelessness"],"interventions":[{"type":"OTHER","name":"Community-based healthcare delivery"},{"type":"DRUG","name":"Lenacapavir"}],"enrollment":100,"startDate":"2026-04-21","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Being reached for mobile health services by a UCLA HHC mobile van\n* ≥18 years of age\n* Able to provide informed consent\n* English or Spanish-speaking\n* Willing and able to comply with study procedures\n* HIV unknown or negative status and HIV negative based on rapid 4th generation Ag/Ab test on the day of enrollment\n* At-risk for HIV, based on clinician assessment (based on CDC guidelines; includes any individual requesting PrEP, regardless of reported risk factors for HIV)\n* Pregnant and breastfeeding women/people can be offered LEN with counseling about benefits and risks.\n\nExclusion Criteria:\n\n* Any clinical or psychosocial condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to take LEN PrEP\n* Known hypersensitivity to the study drug, the metabolites, or formulation excipient\n* BMI \\<35 kg/m2 (77 pounds)\n* On oral or other long-acting PrEP and unwilling to discontinue\n* Already taking LEN for HIV prevention\n* Known HIV diagnosis or positive 4th generation HIV Ab/Ag test (on day of enrollment) or subsequent lab-based confirmatory testing.","locations":[{"facility":"UCLA Health Homeless Healthcare Collaborative","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Risa Hoffman, MD, MPH","phone":"310-206-6766","email":"rhoffman@mednet.ucla.edu"},{"name":"Daisy Walker, MPH","phone":"424-832-6674","email":"DaisyWalker@mednet.ucla.edu"}],"primaryOutcomes":["Uptake of LEN PrEP"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["santa-monica-california"],"enrichment":{"headline":"Not a traditional drug phase: testing Lenacapavir for HIV Prevention","inPlainEnglish":"This project evaluates the implementation strategy of the delivery of lenacapavir pre-exposure prophylaxis (LEN PrEP) - a newly available long-acting, injectable medication for human immunodeficiency virus (HIV) prevention - via a mobile health van model for people who are unstably housed in Los Angeles County (LAC). People who are unhoused or are facing housing instability experience significant barriers to accessing HIV prevention care in traditional clinic settings.","whoItsFor":["Ages 18 Years to any","Being reached for mobile health services by a UCLA HHC mobile van","English or Spanish-speaking","Willing and able to comply with study procedures","HIV unknown or negative status and HIV negative based on rapid 4th generation Ag/Ab test on the day of enrollment","At-risk for HIV, based on clinician assessment (based on CDC guidelines; includes any individual requesting PrEP, regardless of reported risk factors for HIV)","Pregnant and breastfeeding women/people can be offered LEN with counseling about benefits and risks"],"whoShouldSkip":["Any clinical or psychosocial condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to take LEN PrEP","Known hypersensitivity to the study drug, the metabolites, or formulation excipient","body-mass index (BMI) \\<35 kg/m2 (77 pounds)","On oral or other long-acting PrEP and unwilling to discontinue","Already taking LEN for HIV prevention","Known HIV diagnosis or positive 4th generation HIV Ab/Ag test (on day of enrollment) or subsequent lab-based confirmatory testing"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Santa Monica. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.400Z"},{"nctId":"NCT07467447","title":"Effect of LY3437943 Versus Placebo in Participants Who Have Obesity or Are Overweight","officialTitle":"A Phase 2 Study of Once-Weekly LY3437943 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Hudson Biotech","sponsorClass":"INDUSTRY","summary":"Phase 2, multicenter, randomized, double-blind, placebo-controlled study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus placebo in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.","conditions":["Obesity"],"keywords":["Retatrutide","LY3437943","triple agonist","GIP receptor agonist","GLP-1 receptor agonist","glucagon receptor agonist","weight loss","body weight","BMI","waist circumference","lifestyle counseling"],"interventions":[{"type":"DRUG","name":"Retatrutide (LY3437943)"},{"type":"DRUG","name":"Placebo"},{"type":"BEHAVIORAL","name":"Standardized diet and physical activity counseling throughout the study."}],"enrollment":300,"startDate":"2026-02-15","completionDate":"2027-03-14","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 75 years (inclusive) at time of informed consent.\n* BMI ≥30 and ≤50 kg/m², OR BMI ≥27 and \\<30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure).\n* Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires.\n* Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum).\n* Male and/or female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding.\n* Capable of giving signed informed consent and complying with protocol requirements.\n\nExclusion Criteria:\n\n* History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma.\n* Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL).\n* Self-reported change in body weight \\>5 kg within 3 months prior to screening.\n* Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty \\>1 year prior).\n* Current/planned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization).\n* Renal impairment: eGFR \\<45 mL/min/1.73 m² (CKD-EPI) at screening.\n* Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility.\n* History of acute or chronic pancreatitis (exception for resolved gallstone pancreatitis post-cholecystectomy).\n* TSH outside 0.4 to 6.0 mIU/L at screening (with protocol-defined exceptions).\n* Obesity due to other endocrine disorders (e.g., Cushing's) or monogenic/syndromic obesity (e.g., Prader-Willi).\n* Psychiatric exclusion criteria including unstable major depressive disorder/severe psychiatric disorder within 2 years; lifetime suicide attempt; PHQ-9 score ≥15; or specified Columbia-Suicide Severity Rating Scale (C-SSRS) findings within past month.\n* Uncontrolled hypertension (systolic ≥160 mmHg and/or diastolic ≥100 mmHg) or elevated resting pulse rate (\\>100 bpm) at baseline.\n* Recent (within 3 months) major cardiovascular events (e.g., MI, stroke, unstable angina, CHF hospitalization); tachyarrhythmia syndromes; NYHA Class III-IV CHF; or ECG abnormalities interfering with interpretation.\n* Acute/chronic hepatitis or liver disease other than NAFLD; or screening labs: ALT \\>3× ULN, ALP \\>1.5× ULN, or total bilirubin \\>1.5× ULN (with exception).\n* Elevated calcitonin at Visit 1 per protocol thresholds; personal/family history of medullary thyroid carcinoma or MEN2.\n* Active/untreated malignancy or remission \\<5 years (with protocol exceptions for certain in-situ/skin cancers).\n* Contraindication to GLP-1 receptor agonists, or other conditions that could prevent protocol compliance (including drug/alcohol abuse or eating disorder), per investigator judgment.\n* Alcohol consumption \\>14 units/week (women) or \\>21 units/week (men).\n* Recent marijuana/THC-containing product use within 3 months or unwillingness to abstain during trial (protocol exception for cannabidiol oil if agrees to refrain).\n* Organ transplant history (except corneal transplant) or awaiting transplant.\n* Hematologic conditions interfering with HbA1c measurement; recent large blood donation/transfusion/severe blood loss; hemoglobin below protocol thresholds.\n* Severe atopy/multiple severe allergies or severe hypersensitivity reactions.\n* Fasting triglycerides \\>500 mg/dL at screening (with stability requirement for lipid-lowering therapy).\n* Significant active, uncontrolled medical condition or history posing risk or interfering with data interpretation, per investigator judgment.\n* History of symptomatic gallbladder disease within past 2 years (protocol-defined exceptions after cholecystectomy).\n* History of documented HIV infection.\n* Chronic systemic glucocorticoid therapy within 3 months or active autoimmune abnormality likely to require systemic steroids during study (with specified formulation exceptions).\n* Recent medications that may cause significant weight gain (e.g., tricyclic antidepressants, atypical antipsychotics, mood stabilizers) within 3 months.\n* Recent use (within 3 months) of medications or remedies intended to promote weight loss (examples listed in protocol, including GLP-1 RAs).\n* Use of metformin or other glucose-lowering medications (e.g., for PCOS or diabetes prevention) not permitted at entry.\n* Started implantable/injectable contraceptives within 18 months prior to screening (IUDs allowed if used ≥3 months).\n* Known allergies to GLP-1 receptor agonists or LY3437943.\n* Currently enrolled in another investigational study or recent participation/treatment within 30 days (or 5 half-lives, whichever longer).\n* Previously received LY3437943 in this or another study.\n* Investigator site personnel directly affiliated with the study and/or their immediate family; or Lilly employees.\n* Note: The publicly posted protocol references additional exclusion criteria numbered 52-57 in a separate protocol addendum (not included in the posted protocol PDF).","locations":[{"facility":"Peking University Shenzhen Hospital","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Seni S Lu, Phd","phone":"+86 13076790030","email":"Seni-Lu@beijing-biotech.com"}],"primaryOutcomes":["Mean percent change in body weight from randomization/baseline to Week 24."],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["retatrutide"],"locationSlugs":["shenzhen-china"],"enrichment":{"headline":"Phase 2: testing Retatrutide (LY3437943) for Obesity","inPlainEnglish":"Phase 2, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus dummy treatment (placebo) in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.","whoItsFor":["Ages 18 Years to 75 Years","body-mass index (BMI) ≥30 and ≤50 kg/m², OR body-mass index (BMI) ≥27 and \\<30 kg/m² with at least 1 weight-related comorbidity (hypertension; dyslipidemia; or cardiovascular disease such as ischemic CVD or NYHA Class I-II heart failure)","Motivated and able/willing to self-inject (or have trained assistance if needed) and follow study procedures, including lifestyle advice and questionnaires","Subgroup (NAFLD addendum): liver fat content ≥10% by MRI-PDFF (for participants invited to the addendum)","Male and/or female; contraception requirements apply; women of childbearing potential must have negative pregnancy tests at specified visits and should not be breastfeeding"],"whoShouldSkip":["History of diabetes mellitus (type 1 or type 2), ketoacidosis, or hyperosmolar state/coma","Screening lab values suggestive of diabetes (HbA1c ≥6.5%; fasting glucose ≥126 mg/dL; or random glucose ≥200 mg/dL)","Self-reported change in body weight \\>5 kg within 3 months prior to screening","Prior or planned surgical treatment for obesity (exceptions: liposuction/abdominoplasty \\>1 year prior)","Current/planned endoscopic or device-based obesity therapy, or device removal within last 6 months (e.g., intragastric balloon, gastric artery embolization)","Renal impairment: eGFR \\<45 mL/min/1.73 m² (CKD-EPI) at screening","Clinically significant gastric emptying abnormality (e.g., severe gastroparesis) or chronic drugs affecting GI motility"],"whatHappens":"If you join, the listed intervention(s) are Retatrutide (LY3437943), Placebo, or Standardized diet and physical activity counseling throughout the study.. The registry lists allocation as randomized. Phase 2, multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating once-weekly subcutaneous retatrutide (LY3437943) at multiple maintenance dose levels versus dummy treatment (placebo) in adults with obesity or overweight with weight-related comorbidities (without type 2 diabetes), alongside standardized diet and physical activity counseling.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 300 people at Shenzhen. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.288Z"},{"nctId":"NCT07467564","title":"The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis","officialTitle":"The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatitis in Gulf Countries","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment. The study enrollment period will be about 9 months with each of the participants undergoing a 6-month observational study period.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab"}],"enrollment":184,"startDate":"2026-02-24","completionDate":"2027-05-24","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression.\n* Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation\n* Participants and/or their legally approved representatives (LAR in case of the minor subject) must agree to sign an informed consent or an assent.\n\nExclusion Criteria:\n\n* Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months.\n* Participants who are participating in another trial.\n* Participants with active chronic or acute infection requiring systemic treatment.\n* Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection.\n* Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.\n* Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site: Hamad Medical Corporation","city":"Doha","state":"","country":"Qatar","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: Saudi Medical Services (Medical Fakeeh)","city":"Jeddah","state":"","country":"Saudi Arabia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: King Faisal Specialist Hospital","city":"Jeddah","state":"","country":"Saudi Arabia","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: NMC Specialty Hospital LTD","city":"Abu Dhabi","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: Dibba Hospital","city":"Fujairah","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: Ibrahem Bin Hamad Hospital","city":"Ras al-Khaimah","state":"","country":"United Arab Emirates","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site: Al Qassimi Hospital","city":"Sharjah city","state":"","country":"United Arab Emirates","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Proportion of Participants with Hospital Anxiety and Depression Scale Anxiety (HADS-A) Sub-scores of Less Than 8","Proportion of Participants with HADS Depression (HADS-D) Sub-scores of less than 8","Change from Baseline in HADS Total Score.","Proportion of Participants with More Than or Equal to 4-point Improvement in POEM Total Score","Change from Baseline in POEM Total Score."],"hasResults":false,"conditionSlugs":["depression","atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["doha-qatar","jeddah-saudi-arabia","abu-dhabi-united-arab-emirates","fujairah-united-arab-emirates","ras-al-khaimah-united-arab-emirates","sharjah-city-united-arab-emirates"],"enrichment":{"headline":"Not a traditional drug phase: testing Dupilumab for Atopic Dermatitis","inPlainEnglish":"This study aims to assess the impact of dupilumab on the mental health and quality of life of moderate-to-severe Atopic Dermatitis (AD) patients. The study will recruit participants from AD patients who are already receiving dupilumab treatment.","whoItsFor":["Ages 12 Years to any","Participants who have moderate to severe AD with signs and symptoms of anxiety and/or depression","Participants who initiate dupilumab therapy within 30 days of enrolment, based on the treating physician's decision, independently of study participation"],"whoShouldSkip":["Females who are pregnant, lactating, or planning/intending to be pregnant in the next 6 months","Participants who are participating in another trial","Participants with active chronic or acute infection requiring systemic treatment","Participants who are diagnosed with active endoparasite infection or are suspected of being at high risk of infection","Participants with human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses","Participants on antidepressants/anti-anxiety within 6 months of enrolment or those who are planning to receive antidepressants/anti-anxiety. In addition, those who will use antidepressants/anti-anxiety medications throughout the study will be excluded from the analysis","The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 184 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.713Z"},{"nctId":"NCT07468695","title":"Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya","officialTitle":"Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fred Hutchinson Cancer Center","sponsorClass":"OTHER","summary":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its efficacy can be suboptimal in WLWH. In Kenya, the estimated incidence rate of cervical cancer is 31-33 per 100,000 women per year among women without HIV and approximately 70-100 per 100,000 among WLWH.\n\nThe proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings. It will also contribute towards achieving the 90-70-90 goals of the WHO strategy for accelerated elimination of cervical cancer as a public health problem by 2030.","conditions":["HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer"],"keywords":["HIV","Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus"],"interventions":[{"type":"PROCEDURE","name":"Thermal ablation (TA) with 1 probe"},{"type":"PROCEDURE","name":"Thermal ablation (TA) with 2 probes"}],"enrollment":300,"startDate":"2026-10-12","completionDate":"2027-12-31","sex":"FEMALE","minAge":"25 Years","maxAge":"49 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","locations":[{"facility":"Coptic Hope Center","city":"Nairobi","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Araceli Loera, MPH","phone":"+1 206-667-5816","email":"aloera@fredhutch.org"},{"name":"Mark A Mounir","phone":"+254 768027841","email":"mmounir@coptichospitals.org"}],"primaryOutcomes":["HPV positive"],"hasResults":false,"conditionSlugs":["cervical-cancer","als","hiv"],"drugSlugs":[],"locationSlugs":["nairobi-kenya"],"enrichment":{"headline":"Not a traditional drug phase: Thermal ablation (TA) with 1 probe for HIV (Human Immunodeficiency Virus)","inPlainEnglish":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. Thermal ablation (TA) is recommended by the World Health Organization (WHO) to treat cervical precancerous lesions, although its how well it works can be suboptimal in WLWH.","whoItsFor":["Ages 25 Years to 49 Years","Women only","who can join specific to the feasibility study","Willing to return to facility at 6 months","Positive hrHPV or VIA test within 3 months of enrollment","Type 1 transformation zone (TZ1)","Thermal ablation eligible"],"whoShouldSkip":["Screened for cervical cancer outside of study in last 6 months","Currently pregnant or less than 6 weeks postpartum","Prior diagnosis of cervical cancer","A history of treatment for cervical precancer","Currently receiving treatment for any cancer","Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study","Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled"],"whatHappens":"If you join, the listed intervention(s) are Thermal ablation (TA) with 1 probe, or Thermal ablation (TA) with 2 probes. The registry lists allocation as randomized. Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Nairobi. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.537Z"},{"nctId":"NCT07470320","title":"Placental Biology in Health and Disease","officialTitle":"Placental Biology in Health and Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Oxford","sponsorClass":"OTHER","summary":"Pre-eclampsia (PET) is a condition characterised by high blood pressure and damage to other organs, and is a leading cause of maternal and fetal complications such as fetal growth restriction (FGR). Gestational diabetes mellitus (GDM) involves abnormal blood sugar levels during pregnancy and can have both short and long-term impacts on the health of the mother and child. Both conditions are linked to placental dysfunction but the precise mechanisms behind these links remain unclear.\n\nA major focus of this study is on extracellular vesicles (EVs) which are tiny, bubble-like particles released by the placenta into the mother's and baby's bloodstreams. These EVs act as messengers, carrying proteins, lipids and genetic material that can influence how cells function, even in parts of the body far from the placenta. Notably, the number and content of these EVs change in conditions like PET and GDM, suggesting they may play a role in the development of these complications.\n\nThis single-site, observational, laboratory study aims to investigate how these EVs contribute to maternal health and disease. To enable analysis across different physiological and pathological conditions pregnant participants with healthy pregnancies, pregnancies predisposed to PET and pregnancies complicated by GDM, FGR and PET will be recruited alongside healthy non-pregnant controls. Recruitment will be from the Oxford University Hospitals NHS Foundation Trust and the Nuffield Department of Women's and Reproductive Health, University of Oxford (who fund the research). Demographic and clinical data will be collected as well as blood, urine, breath, voice, placenta, umbilical cord, umbilical cord blood, amniotic fluid and/or uterine vein blood samples.\n\nThrough examining EV content and function, it is hoped a better understanding of their role in pregnancy complications will be gained, including their potential as non-invasive biomarkers for early detection and targeted treatments, improving outcomes for mothers and babies worldwide.","conditions":["Pre-eclampsia","Gestational Diabetes Mellitus (GDM)","Fetal Growth Restriction (FGR)","Pregnancy Induced Hypertension (PIH)","Placenta","Pregnancy"],"keywords":[],"interventions":[{"type":"OTHER","name":"There are no interventions for this study"}],"enrollment":1000,"startDate":"2025-12-16","completionDate":"2030-05-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Female, aged 18 years or above\n* Willing and able to give informed consent for participation in the study\n* Able to read and understand written and spoken English to comprehend study materials and give informed consent\n* Non-pregnant women in good general health OR pregnant women who fall into one of the following:\n\n  * Healthy pregnancy\n  * Pre-eclampsia (PET) - defined by clinical diagnostic criteria, including hypertension and proteinuria\n  * Gestational diabetes mellitus (GDM) - diagnosed by standard glucose tolerance tests during pregnancy\n  * Fetal growth restriction (FGR) - diagnosed based on fetal weight or Doppler abnormalities\n  * Predisposed to PET - high-risk factors for PET such as maternal type 1 or type 2 diabetes, autoimmune diseases or multiple pregnancies\n\nExclusion Criteria:\n\n* Non-pregnant participants with active health conditions that could confound study outcomes\n* Pregnant participants with conditions unrelated to PET, GDM or FGR that could influence EV profiles e.g. active infections or malignancies","locations":[{"facility":"Oxford University Hospitals NHS Foundation Trust","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Professor Manu Vatish","phone":"+441865 221009","email":"manu.vatish@wrh.ox.ac.uk"}],"primaryOutcomes":["Enhanced understanding of the molecular and cellular mechanisms linking placental EVs to maternal systemic inflammation in PET and GDM."],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: There are no interventions for this study for Pre-eclampsia","inPlainEnglish":"Pre-eclampsia (PET) is a condition characterised by high blood pressure and damage to other organs, and is a leading cause of maternal and fetal complications such as fetal growth restriction (FGR). Gestational diabetes mellitus (GDM) involves abnormal blood sugar levels during pregnancy and can have both short and long-term impacts on the health of the mother and child.","whoItsFor":["Ages 18 Years to any","Women only","Female, aged 18 years or above","Non-pregnant women in good general health OR pregnant women who fall into one of the following:","Pre-eclampsia (PET) - defined by clinical diagnostic criteria, including hypertension and proteinuria","Gestational diabetes mellitus (GDM) - diagnosed by standard glucose tolerance tests during pregnancy","Fetal growth restriction (FGR) - diagnosed based on fetal weight or Doppler abnormalities","Predisposed to PET - high-risk factors for PET such as maternal type 1 or type 2 diabetes, autoimmune diseases or multiple pregnancies"],"whoShouldSkip":["Non-pregnant participants with active health conditions that could confound study outcomes","Pregnant participants with conditions unrelated to PET, GDM or FGR that could influence EV profiles e.g. active infections or malignancies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Oxford. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.037Z"},{"nctId":"NCT07472582","title":"A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men","officialTitle":"A Chatbot to Reduce Chemsex and HIV-related Risk Behaviors Among Men Who Have Sex With Men: a Pilot Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to investigate whether receiving chatbot-delivered stage-of-change-tailored online interventions is effective in reducing chemsex among men who have sex with men in Hong Kong. The main question it aims to answer is:\n\nDoes chatbot-delivered stage-of-changed online interventions reduce chemsex among men who have sex with men\n\nEligible participants will be randomly assigned to either the intervention or the control group. The control group will watch one online video introducing chemsex-related knowledge and harm reduction skills per week for 12 weeks. On top of the interventions received by the control group, participants in the intervention group will have access to a chatbot during the 12-week intervention period. The chatbot will deliver 12 weekly episodes of interventions tailored to once's current stage-of-change related to chemsex. The chatbot will also address questions related to chemsex during the intervention period.","conditions":["Behavior"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Chatbot-delivered online interventions and online videos"},{"type":"BEHAVIORAL","name":"Online videos only"}],"enrollment":100,"startDate":"2026-04-01","completionDate":"2027-03-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Hong Kong men aged at least 18 years\n* Able to understand Cantonese\n* Had anal intercourse with at least one man within the past six months\n* Willingness to provide contact information for follow-up\n* Having access to WhatsApp\n\nExclusion Criteria:\n\n* Self-reported a diagnosis of schizophrenia or bipolar disorder","locations":[{"facility":"Centre for Health Behaviours Research, JC School of Public Health and Primary Care, the Chinese University of Hong Kong","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zixin Wang, PhD","phone":"+852 22528474","email":"wangzx@cuhk.edu.hk"}],"primaryOutcomes":["Presence of chemsex in the past 3 months"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: Chatbot-delivered online interventions and online videos for Behavior","inPlainEnglish":"The goal of this clinical trial is to see if receiving chatbot-delivered stage-of-change-tailored online interventions is effective in reducing chemsex among men who have sex with men in Hong Kong. The main question it aims to answer is: Does chatbot-delivered stage-of-changed online interventions reduce chemsex among men who have sex with men Eligible you would be randomly assigned to either the intervention or the control group.","whoItsFor":["Ages 18 Years to any","Men only","Hong Kong men aged at least 18 years","Had anal intercourse with at least one man within the past six months","Willingness to provide contact information for follow-up","Having access to WhatsApp"],"whoShouldSkip":["Self-reported a diagnosis of schizophrenia or bipolar disorder"],"whatHappens":"If you join, the listed intervention(s) are Chatbot-delivered online interventions and online videos, or Online videos only. The registry lists allocation as randomized. The goal of this clinical trial is to see if receiving chatbot-delivered stage-of-change-tailored online interventions is effective in reducing chemsex among men who have sex with men in Hong Kong.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Hong Kong. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.533Z"},{"nctId":"NCT07472842","title":"Study on the Outcomes of Patients Treated in Gynecological Emergency Departments for Pelvic Endometriosis or Suspected Pelvic Endometriosis","officialTitle":"Study on the Outcomes of Patients Treated in Gynecological Emergency Departments for Pelvic Endometriosis or Suspected Pelvic Endometriosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Centre Hospitalier Intercommunal Creteil","sponsorClass":"OTHER","summary":"Adult patients consulting the gynecological emergency department of CHI Créteil during the inclusion period for endometriosis or symptoms suggestive of endometriosis","conditions":["Endometriosis","Pelvic Pain Syndrome","Chronic Gynaecological Disease"],"keywords":["infertility","dysmenorrhea","pelvic pain"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Emergency care for endometriosis"}],"enrollment":200,"startDate":"2025-10-16","completionDate":"2026-01-15","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria :\n\n* Adult patient (aged 18 or over)\n* Patient consulting the gynecological emergency department at Créteil Hospital for\n* Known endometriosis or\n* Symptoms suggestive of endometriosis: dysmenorrhea, pelvic pain, cyclic dysuria, dyspareunia, cyclic dyschezia, infertility, rectal bleeding, chest pain, catamenial hematuria\n* Patient who speaks French and is able to understand the information sheet\n\nExclusion Criteria:\n\n* Minor or menopausal patient\n* Pregnant and breastfeeding patient\n* Other reason for consultation\n* Patient refusal\n* Patient not affiliated with a social security system\n* Patient cannot be contacted for the 3-months questionnaire","locations":[{"facility":"CHI Créteil","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yann SALHI, MD","phone":"01 57 02 20 00","email":"yann.salhi@chicreteil.fr"}],"primaryOutcomes":["Assessing the impact of treatment in gynecological emergency departments on patients with endometriosis or suspected endometriosis","Assessing the impact of treatment in gynecological emergency departments on patients with endometriosis or suspected endometriosis","Assessing the impact of treatment in gynecological emergency departments on patients endometriosis or suspected endometriosis","Assessing the impact of deprivation on the future of patients after consultation at gynaecological emergency departments."],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["cr-teil-france"],"enrichment":{"headline":"Not a traditional drug phase: Emergency care for endometriosis for Endometriosis","inPlainEnglish":"Adult patients consulting the gynecological emergency department of CHI Créteil during the inclusion period for endometriosis or symptoms suggestive of endometriosis","whoItsFor":["Ages 18 Years to any","Women only","Adult patient (aged 18 or over)","Patient consulting the gynecological emergency department at Créteil Hospital for","Known endometriosis or","Symptoms suggestive of endometriosis: dysmenorrhea, pelvic pain, cyclic dysuria, dyspareunia, cyclic dyschezia, infertility, rectal bleeding, chest pain, catamenial hematuria"],"whoShouldSkip":["Minor or menopausal patient","Pregnant and breastfeeding patient","Other reason for consultation","Patient not affiliated with a social security system","Patient cannot be contacted for the 3-months questionnaire"],"whatHappens":"If you join, the listed intervention(s) are Emergency care for endometriosis. The registry lists allocation as na. Adult patients consulting the gynecological emergency department of CHI Créteil during the inclusion period for endometriosis or symptoms suggestive of endometriosis","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Créteil. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.116Z"},{"nctId":"NCT07473778","title":"Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention","officialTitle":"Pioneering Research to Optimize Pre-exposure Prophylaxis (PrEP) Expansion With Lenacapavir (LEN)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The goal of this observational study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.\n\nThe primary objective of this study is to evaluate real-life persistence on LEN PrEP at Week 52 in diverse clinical settings in the United States.","conditions":["HIV Infections"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lenacapavir Injection"},{"type":"DRUG","name":"Emtricitabine/tenofovir disoproxil fumarate (F/TDF)"},{"type":"DRUG","name":"Emtricitabine/tenofovir alafenamide (F/TAF)"},{"type":"DRUG","name":"Cabotegravir (CAB)"},{"type":"DRUG","name":"Lenacapavir Tablet"}],"enrollment":3000,"startDate":"2026-03-17","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Able to comprehend and provide a signed written informed consent, which must be obtained prior to initiation of screening study procedures;\n* Willing and able to comply with all study requirements;\n* Presents at a study site needing or wanting PrEP for HIV prevention as determined by local clinical practice guidelines and institutional protocols, including new PrEP users (PrEP naïve) and current or former users of oral (emtricitabine/tenofovir disoproxil fumarate (coformulated; Truvada®; F/TDF) or emtricitabine/tenofovir alafenamide (coformulated; Descovy®; F/TAF)) or injectable (LEN or cabotegravir (CAB)) PrEP who indicate interest in discussing PrEP methods that they are clinically eligible to receive;\n* Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;\n* After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:\n\n  1. Selects LEN PrEP as their chosen PrEP method; OR,\n  2. Selects a different PrEP method or chooses not to start or continue PrEP.\n\nKey Exclusion Criteria:\n\n* Any other indication not already listed above that would make the participant ineligible for LEN PrEP at enrollment according to local guidelines, organizational protocols, US Prescribing Information (USPI) for the PrEP product, and/or Center for Disease and Control (CDC) guidance.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"UAB 1917 Research Clinic","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Oaks Medical Group","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruane Clinical Research Group Inc.","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health- East Bay Advanced Care","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Family Health Centers of San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego (UCSD) AntiViral Research Center (AVRC)","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mills Clinical Research","city":"West Hollywood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vivent Health","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bliss Health","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pineapple Healthcare Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AHF - Pensacola","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faebris Medical & Community Education","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grady Memorial Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DOM/Project WISH Research Clinic","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center/Division of Infectious Diseases","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruth M. Rothstein CORE Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Howard Brown Health","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Clinic NOLA","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ochsner Baptist Medical Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chase Brexton Health Care","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fenway Health","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Well Medical Center","city":"Berkley","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Health","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Aliveness Project","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"KC Care Health Center","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine Infectious Disease Clinical Research Unit","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center/Nebraska Medicine Specialty Care Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYC Health + Hospitals / Bellevue","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colombia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BronxCare Health System","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati College of Medicine","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University Infectious Diseases Clinical Trials Unit","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perelman Center for Advanced Medicine","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Philadelphia FIGHT","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Abounding Prosperity Inc.","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prism Health","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Health","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Street at Quentin Mease Health Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kelley-Ross Pharmacy","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia Health Right, Inc.","city":"Charleston","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Proportion of Participants with LEN PrEP Persistence at Week 52"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["birmingham-alabama","beverly-hills-california","los-angeles-california","oakland-california","san-diego-california","west-hollywood-california","denver-colorado","miami-florida","orlando-florida","pensacola-florida","atlanta-georgia","chicago-illinois","new-orleans-louisiana","baltimore-maryland","boston-massachusetts","berkley-michigan","detroit-michigan","minneapolis-minnesota","kansas-city-missouri","st-louis-missouri","omaha-nebraska","new-york-new-york","the-bronx-new-york","cincinnati-ohio","columbus-ohio","philadelphia-pennsylvania","charleston-south-carolina","nashville-tennessee","dallas-texas","houston-texas","seattle-washington","charleston-west-virginia"],"enrichment":{"headline":"Not a traditional drug phase: testing Lenacapavir Injection for HIV Infections","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to generate real-life information on the use of lenacapavir (LEN, YEZTUGO®, (YTG)) for pre-exposure prophylaxis (PrEP) across diverse clinical settings in the United States. The study will characterize how PrEP is initiated, used, and discontinued in routine clinical practice when LEN is added as PrEP option and will evaluate persistence on LEN PrEP.","whoItsFor":["Ages 18 Years to any","Willing and able to comply with all study requirements;","Eligible for LEN PrEP per standard of care procedures, for example, being HIV-1 negative at screening using a Food and Drug Administration (FDA) approved/cleared test for diagnosis of acute or primary HIV-1 infection;","After PrEP counseling to learn about the advantages and disadvantages of various PrEP methods:","Selects LEN PrEP as their chosen PrEP method; OR,","Selects a different PrEP method or chooses not to start or continue PrEP"],"whoShouldSkip":["Note: Other protocol defined Inclusion/"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.396Z"},{"nctId":"NCT07476326","title":"Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma","officialTitle":"A Randomized, Double-Blind, Parallel, Multicenter, Two-Arm Study to Compare the Pharmacokinetics, Safety, and Immunogenicity Between Bmab1700 and Opdivo® After Complete Resection of Stage IIB/C, Stage III, or Stage IV Melanoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Biocon Biologics UK PLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.","conditions":["Melanoma"],"keywords":["Neoplasm","Programmed cell death-protein 1(PD-1)","Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)","Monoclonal antibody","Immunoglobulins"],"interventions":[{"type":"DRUG","name":"Bmab1700"},{"type":"DRUG","name":"Opdivo"}],"enrollment":120,"startDate":"2026-09-09","completionDate":"2027-08-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants greater than or equal to (\\>=)18 years of age on the day of signing informed consent (follow local regulatory requirements if the legal age of consent for study participation is \\>18 years old).\n2. Able to understand and willing to provide consent using the study Informed Consent Form (ICF). The voluntarily signed ICF must be obtained before any study-specific procedures are performed.\n3. Histologically or cytologically confirmed Stage IIB, Stage IIC, Stage III, or Stage IV melanoma (per American Joint Committee on Cancer, 8th edition) that was completely surgically resected. Complete surgical resection requires removal of all clinically or radiographically evident regional disease. Completion of lymph node dissection is not required unless clinically indicated. Participants must have been surgically rendered free of disease with negative margins on resected specimens documented by appropriate pathology and surgical reports.\n4. Complete surgical resection of melanoma must have been performed within 12 weeks before randomization.\n5. All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n7. Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator.\n\nExclusion Criteria:\n\n1. History of ocular/uveal melanoma.\n2. Participants with an active, known, or suspected autoimmune disease are to be excluded from participation. Participants who have received systemic treatment for an autoimmune disease within the past 2 years before randomization (eg, with disease-modifying agents, corticosteroids, or immunosuppressive drugs) are also excluded.\n3. History of active malignancy other than melanoma under study within 3 years before randomization, except for locally curable early-stage cancers (carcinoma in situ or Stage I) that have been curatively treated, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.\n4. Participants with a condition requiring systemic treatment with either corticosteroids \\>10 mg daily prednisone or equivalent or other immunosuppressive medications within 14 days before randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \\<=10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease\n5. Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention.\n6. Use of an investigational agent or an investigational device within 28 days or 5 half-lives (if half-life is known for the investigational agent), whichever is longer, before randomization or have not recovered from AEs associated with such therapies to Grade 1 or below (based on CTCAE Version 6.0).\n7. Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion).\n8. Participants who have received a live/attenuated vaccine within 28 days before randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine.\n9. Expected to receive any other form of antineoplastic therapy during the clinical study.\n10. Participants who received previous systemic therapy with any of the following: anti-programmed cell death-protein 1 (PD-1), anti programmed cell death-ligand 1 (PD-L1), anti-programmed cell death-ligand 2 (PD-L2), anti-CD137, anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibodies (including nivolumab or pembrolizumab or ipilimumab or other CTLA-4 targeting agents), chimeric antigen receptor T-cell therapy cells, or any agents targeting the IL-2 pathway or other T-cell co-stimulation/ checkpoint pathways.\n11. Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care.\n12. Participants will be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:\n\n    1. White blood cells: less than (\\<) 2000 per microliter\n    2. Neutrophils: \\<1500 per microliter\n    3. Platelets: \\<100 \\*103 per microliter\n    4. Hemoglobin: \\<9.0 gram per deciliter (g/dL)\n    5. Participants with estimated creatinine clearance (CrCl) (measured or calculated) less than or equal to (\\<=) 40 milliliter per minute (mL/min).\n\n       • CrCl: using the Cockroft-Gault formula:\n       * Female CrCl = \\[(140 - age in years) \\* weight in kilogram (kg) \\* 0.85\\] divided by (72 \\* serum creatinine in milligram per deciliter \\[mg/dL\\])\n       * Male CrCl = \\[(140 - age in years) \\* weight in kg \\* 1.00\\] divide by (72 \\* serum creatinine in mg/dL)\n    6. Aspartate aminotransferase: greater than (\\>) 2.5 \\* upper limit of normal (ULN)\n    7. Alanine aminotransferase: \\>2.5 \\* ULN\n    8. Total bilirubin \\>1.5 \\* ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of \\<3.0 \\* ULN)\n13. Participants positive for human immune deficiency virus (HIV-1 and HIV-2) tests. Screening for HIV infection must adhere to local regulatory guidelines and confirm the absence of HIV-1 and HIV-2 infection.\n\n    Note: Participants with documented HIV infection may be enrolled where required by local regulatory or ethics committee guidance, provided all the following criteria are met:\n    * The participant is on stable antiretroviral therapy for at least 12 weeks prior to the first dose of study treatment, and no planned change in antiretroviral therapy regimen during the PK sampling period.\n    * Adequate immune function, defined as: CD4+ T cell count greater than or equal to (\\>=) 350 cells per millimeter cube (cells/mm\\^3) at screening\n    * No history of uncontrolled or recent Acquired Immunodeficiency Syndrome (AIDS) defining illness, that is \\[ie\\], no active AIDS defining condition within the past 12 months\n    * Undetectable viral RNA load\n14. Participants having positive test result for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating presence of virus, eg, hepatitis B surface antigen (Australia antigen) positive, or hepatitis C antibody (anti- HCV) positive (except if HCV RNA negative).\n15. Participants with history or current evidence of any clinically significant medical condition (including but not limited to physical examination, vital signs, electrocardiogram \\[ECG\\] findings, laboratory results), or ongoing therapy, that could confound study results, increase participation risk, or are deemed not in the participant's best interest by the treating investigator.\n16. Known history of allergy or hypersensitivity to IMP components.\n17. Known history of severe hypersensitivity reaction (Grade \\>=3) to any monoclonal antibody.\n18. Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n19. Has documented or known current alcohol/drug abuse that precludes the participant's ability to adhere to the protocol.\n20. Prisoners or participants who are involuntarily incarcerated.","locations":[{"facility":"Biocon Investigational Site","city":"Bento Gonçalves","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Ijuí","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Pará","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Porto Alegre","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Rio de Janeiro","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Santa Catarina","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 2","city":"Santa Catarina","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Santa Catarina","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 2","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Providencia","state":"","country":"Chile","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Recoleta","state":"","country":"Chile","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Santiago","state":"","country":"Chile","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Santiago","state":"","country":"Chile","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Batumi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Kutaisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 3","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 4","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 5","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Chisinau","state":"","country":"Moldova","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Cluj-Napoca","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Craiova","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Kamenitz","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Kragujevac","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"George","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Johannesburg","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Johannesburg","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Murcia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Sabadell","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site 1","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Bornova","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Konak","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Biocon Investigational Site","city":"Kyiv","state":"","country":"Ukraine","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr. Gursharan Singh, MBBS; PhD Pharm Med; LLM-IP","phone":"+91 80 2808 2066","email":"gursharan.singh@biocon.com"},{"name":"Rajesh CN","phone":"+91 9725466994","email":"rajesh.cn@biocon.com"}],"primaryOutcomes":["Area Under the Concentration-Time Curve from Time 0 (Day 1) To Day 29 After the First Dose (AUC0-28days) of Bmab 1700 and Opdivo","Area Under the Concentration-Time Curve Over a Dosing Interval (AUC0-tau) of Bmab 1700 and Opdivo"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["nivolumab"],"locationSlugs":["bento-gon-alves-brazil","iju-brazil","par-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","santa-catarina-brazil","s-o-paulo-brazil","providencia-chile","recoleta-chile","santiago-chile","batumi-georgia","kutaisi-georgia","tbilisi-georgia","chisinau-moldova","bucharest-romania","cluj-napoca-romania","craiova-romania","belgrade-serbia","kamenitz-serbia","kragujevac-serbia","ni-serbia","george-south-africa","johannesburg-south-africa","barcelona-spain","madrid-spain","murcia-spain","sabadell-spain","seville-spain","ankara-turkey-t-rkiye","bornova-turkey-t-rkiye","konak-turkey-t-rkiye","ivano-frankivsk-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 1: testing Bmab1700 for Melanoma","inPlainEnglish":"This study wants to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.","whoItsFor":["Ages 18 Years to any","Complete surgical resection of melanoma must have been performed within 12 weeks before randomization","All participants must have disease-free status documented by a complete physical examination and imaging studies before randomization","Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1","Participants must have recovered from melanoma related surgery and its complications before randomization, as per investigator"],"whoShouldSkip":["History of ocular/uveal melanoma","Female participants who are pregnant or breastfeeding at the screening visit, or who intend to become pregnant or breastfeed at any time during the study and for 150 days after the last dose of study intervention","Any antineoplastic therapy after the complete resection of melanoma under study (eg, chemotherapy, radiation therapy, targeted agents, biotherapy, or limb perfusion)","Expected to receive any other form of antineoplastic therapy during the clinical study","Treatment with complementary medications (eg, herbal supplements or traditional medicines) with an antineoplastic intent to treat the melanoma within 2 weeks before randomization. Such medications are permitted if they are used as supportive care","you would be excluded if clinical assessment or laboratory investigations before randomization demonstrate any of the following:","White blood cells: less than (\\<) 2000 per microliter"],"whatHappens":"If you join, the listed intervention(s) are Bmab1700, or Opdivo. The registry lists allocation as randomized. This study wants to investigate the pharmacokinetics (PK) similarity of Bmab1700 (an intended nivolumab biosimilar), compared with United States (US)-licensed Opdivo, in participants after complete surgical removal of melanoma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 120 people at 46 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.804Z"},{"nctId":"NCT07477691","title":"Immune Modulation During Palynziq® Treatment in Adults (IMPALA)","officialTitle":"A Phase 4 Study of Immune Modulation During Palynziq® Treatment in Adults With Phenylketonuria (PKU)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BioMarin Pharmaceutical","sponsorClass":"INDUSTRY","summary":"Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and efficacy in adults with PKU.","conditions":["Phenylketonuria"],"keywords":["PKU","Phenylketonuria","Pegvaliase","Palynziq","Methotrexate","Immune Response","Safety","Immune Modulation","BMN 165-401","Hyperphenylalaninemia","Enzyme Substitution Therapy","Pharmacologic Immunosuppression"],"interventions":[{"type":"BIOLOGICAL","name":"Pegvaliase"},{"type":"DRUG","name":"Methotrexate"}],"enrollment":12,"startDate":"2026-05-29","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults between 18 and 65 years old\n* Have a confirmed diagnosis of phenylketonuria (PKU)\n* Are in generally good health based on medical evaluation\n* Are willing and medically eligible to receive Palynziq and methotrexate (MTX) Cohort A: Have never taken Palynziq before and are willing to start it during the study Cohort B: Have blood \\> 600 μmol/L after taking Palynziq for at least 24 weeks, are on a daily dose of at least 20mg and unable to increase the dose further\n* Agree to use required contraception if they or their partner could become pregnant\n* Are willing to carry two epinephrine devices at all times during Palynziq treatment\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, planning to become pregnant, planning to father a child, or not using effective birth control if applicable\n* Have a known severe allergy or hypersensitivity reaction to methotrexate (MTX), Palynziq, or other PEG-containing medications\n* Have a serious active infection or a history of severe or recurrent infections\n* Have significant medical conditions that may affect safety or participation (such as serious heart, lung, liver, kidney, immune, neurological, psychiatric, or cancer-related conditions)\n* Have a history of substance or alcohol abuse within the past 12 months\n* Have had an organ transplant or are taking chronic immunosuppressive medications\n* Are currently taking medications that are not allowed in the study, including other PKU treatments besides Palynziq\n* Are using, or plan to use, injectable PEG-containing medications other than Palynziq during the study\n* Have major surgery planned during the study participation period\n* Are currently participating in another clinical study involving Palynziq\n* In the opinion of the study doctor, are not a suitable candidate for the study or may have difficulty complying with study requirements","locations":[{"facility":"UCLA Dept. of Human Genetics","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of South Florida Medical Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ann & Robert H. Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota Medical School","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center (URMC)","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University (OHSU) - PARENT","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center (UPMC) - Children's Hospital of Pittsburgh","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Hospital","city":"Salt Lake City","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Specialist","phone":"1-800-983-4587","email":"medinfo@bmrn.com"}],"primaryOutcomes":["Change in blood Phe levels from baseline to Week 25 and Week 49","Anti-PEG IgG, IgM, anti-PAL IgG, IgM levels at Weeks 5, 9, 25, and 49"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","aurora-colorado","tampa-florida","chicago-illinois","indianapolis-indiana","minneapolis-minnesota","rochester-new-york","portland-oregon","pittsburgh-pennsylvania","dallas-texas","salt-lake-city-utah","milwaukee-wisconsin"],"enrichment":{"headline":"Phase 4: testing Pegvaliase for Phenylketonuria","inPlainEnglish":"Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and how well it works in adults with PKU.","whoItsFor":["Ages 18 Years to 65 Years","Adults between 18 and 65 years old","Have a confirmed diagnosis of phenylketonuria (PKU)","Are in generally good health based on medical evaluation","Agree to use required contraception if they or their partner could become pregnant","Are willing to carry two epinephrine devices at all times during Palynziq treatment"],"whoShouldSkip":["Pregnant, breastfeeding, planning to become pregnant, planning to father a child, or not using effective birth control if applicable","Have a known severe allergy or hypersensitivity reaction to methotrexate (MTX), Palynziq, or other PEG-containing medications","Have a serious active infection or a history of severe or recurrent infections","Have significant medical conditions that may affect safety or participation (such as serious heart, lung, liver, kidney, immune, neurological, psychiatric, or cancer-related conditions)","Have a history of substance or alcohol abuse within the past 12 months","Have had an organ transplant or are taking chronic immunosuppressive medications","Are currently taking medications that are not allowed in the study, including other PKU treatments besides Palynziq"],"whatHappens":"If you join, the listed intervention(s) are Pegvaliase, or Methotrexate. The registry lists allocation as randomized. Study 165-401 is a Phase 4, open-label study designed to examine the concomitant use of methotrexate (MTX) to suppress immune responses to Palynziq and improve tolerability and how well it works in adults with PKU.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 12 people at 12 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.779Z"},{"nctId":"NCT07478653","title":"MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease","officialTitle":"MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Oelisoa Andriankaja","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question\\[s\\] it aims to answer \\[is/are\\]:\n\nif dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.\n\nParticipants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.","conditions":["Obesity","Dental Care for Children"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Dental Cleaning and Oral Hygiene Instruction (OHI)"},{"type":"BEHAVIORAL","name":"Oral Hygiene Instruction (OHI)"}],"enrollment":50,"startDate":"2026-08-31","completionDate":"2028-07-31","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)\n* Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex)\n\nExclusion Criteria:\n\n* Same exclusion as parent study.\n* Planning to receive or complete dental services during the 12-month course of the study\n* Ongoing orthodontic treatment\n* Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment\n* Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids)\n* Local or systemic antibiotic use within 15 days prior to enrollment or for \\>10 days within the past 3 months\n* History of bleeding disorders\n* Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months","locations":[{"facility":"University of Kentucky","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Oelisoa Mireille Andriankaja, DDS, MS, PhD","phone":"8595620597","email":"oelisoa.andriankaja@uky.edu"},{"name":"Shaddox","phone":"","email":"oelisoa.andriankaja@uky.edu"}],"primaryOutcomes":["Change in gingival index","Change in probing depth","Change in BOP (Bleeding on probing)","Change in Plaque Index","Change in Clinical Attachment Level (CAL)","Change in Gingival Margin Position (GM)","Number of participants with Supragingival and Subgingival Calculus","Change in Gingival Crevicular Fluid (GCF)","Change in Bacterial Subgingival Biofilm","Change in levels of Interleukin-1 beta (IL-1β)","Change in levels of Tumor Necrosis Factor-alpha","Change in levels of Interleukin-6 (IL-6)","Change in levels of C-reactive protein (CRP)","Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)","Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)","Change in levels of endocan","Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)","Change in Oral Microbiome","Change in active oral microbiome (RNA sequencing)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["lexington-kentucky"],"enrichment":{"headline":"Not a traditional drug phase: Dental Cleaning and Oral Hygiene Instruction (OHI) for Obesity","inPlainEnglish":"The goal of this clinical trial is to assess whether added on top of your current treatment dental cleaning can enhance the effects of semaglutide in children with obesity. The main question\\[s\\] it aims to answer \\[is/are\\]: if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.","whoItsFor":["Ages 12 Years to 17 Years","participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)","Class 2 or 3 obesity (body-mass index (BMI) =120% of the 95th percentile for age and sex)"],"whoShouldSkip":["Same exclusion as parent study","Planning to receive or complete dental services during the 12-month course of the study","Ongoing orthodontic treatment","Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment","Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids)","Local or systemic antibiotic use within 15 days prior to enrollment or for \\>10 days within the past 3 months","History of bleeding disorders"],"whatHappens":"If you join, the listed intervention(s) are Dental Cleaning and Oral Hygiene Instruction (OHI), or Oral Hygiene Instruction (OHI). The registry lists allocation as randomized. The goal of this clinical trial is to assess whether added on top of your current treatment dental cleaning can enhance the effects of semaglutide in children with obesity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Lexington. Taking part typically means following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.736Z"},{"nctId":"NCT07479329","title":"Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes","officialTitle":"Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Institut d'Investigacions Biomèdiques August Pi i Sunyer","sponsorClass":"OTHER","summary":"This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy.\n\nWomen with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.","conditions":["Type 1 Diabetes","Preeclampsia","Preeclampsia (PE) Risk"],"keywords":["Type 1 Diabetes","Preeclampsia","Preeclampsia Risk","Preclinical carotid atherosclerosis","Carotid ultrasonography","Cardiovascular risk","Cardiovascular disease"],"interventions":[],"enrollment":1300,"startDate":"2026-04-10","completionDate":"2028-04-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of type 1 diabetes\n* At least one prior pregnancy with first-trimester preeclampsia screening (\\<14 weeks gestation)\n* ≥3 years since last pregnancy\n\nExclusion Criteria:\n\n* Previous multiple pregnancy\n* Cardiovascular disease before pregnancy (coronary heart disease, stroke/TIA, peripheral artery disease, heart failure)\n* Active pregnancy at time of evaluation\n* Alcohol or substance dependence (except nicotine/caffeine) in the last 3 years\n* Active severe psychiatric disease, dementia, severe disability, or reduced life expectancy","locations":[{"facility":"Hospital Clínic Barcelona","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Mútua Terrassa","city":"Terrassa","state":"Terrassa","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Verónica Perea, MD, PhD","phone":"+34 93 736 50 50","email":"vperea@mutuaterrassa.cat"},{"name":"Antonio J. Amor, MD, PhD","phone":"+34932279846","email":"ajamor@clinic.cat"}],"primaryOutcomes":["Number of carotid plaques","Hemoglobin A1c (HbA1c)","Lipid profile","Blood pressure","Body mass index","Diabetic-related chronic microvascular complications","Incident cardiovascular events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["barcelona-spain","terrassa-spain"],"enrichment":{"headline":"Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis …","inPlainEnglish":"This multicenter watch-and-measure (no experimental treatment required) cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy. Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms.","whoItsFor":["Ages 18 Years to any","Women only","Confirmed diagnosis of type 1 diabetes","At least one prior pregnancy with first-trimester preeclampsia screening (\\<14 weeks gestation)","≥3 years since last pregnancy"],"whoShouldSkip":["Previous multiple pregnancy","Cardiovascular disease before pregnancy (coronary heart disease, stroke/TIA, peripheral artery disease, heart failure)","Active pregnancy at time of evaluation","Alcohol or substance dependence (except nicotine/caffeine) in the last 3 years","Active severe psychiatric disease, dementia, severe disability, or reduced life expectancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,300 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.042Z"},{"nctId":"NCT07483073","title":"A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease","officialTitle":"A Master Protocol for Phase 2, Randomized, Controlled Studies of Multiple Interventions for the Treatment of Adults With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group. The studies aim to evaluate the efficacy and safety of new treatments in adults with moderately to severely active ulcerative colitis or Crohn's disease and will last at least 62 weeks.","conditions":["Colitis, Ulcerative","Crohn Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mirikizumab - Intravenous (IV)"},{"type":"DRUG","name":"Mirikizumab - Subcutaneous (SC)"},{"type":"DRUG","name":"LY4395089"}],"enrollment":60,"startDate":"2026-05-04","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD.\n* For UC:\n\n  * Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1.\n* For CD:\n\n  * Have moderately to severely active CD as defined by a Crohn's disease activity index (CDAI) score ≥ 220 and less than or equal to (≤) 450. Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for participants with ileal-colonic or ≥4 for participants with isolated ileal disease.\n* Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD\n* Have screening laboratory test results within the protocol specified parameters.\n\nExclusion Criteria:\n\n* Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis\n\n  * For UC - must not have a current diagnosis of CD\n  * For CD - must not have a current diagnosis of UC\n* Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol\n* Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome\n* Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data\n* Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action\n* Must not have failed an anti-interleukin-23p19 (anti-IL-23p19) antibody treatment\n* Must not have received or will need any prohibited medications for UC or CD as specified in the protocol","locations":[{"facility":"Mayo Clinic in Arizona - Scottsdale","city":"Scottsdale","state":"Arizona","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Biopharma Informatic, LLC","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research LLC","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Denver Gastroenterology","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Health Research - Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ezy Medical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Gastroenterology Associates - Peachtree Dunwoody","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Digestive Health Center","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Western Michigan, PLC d.b.a. 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Campus Mitte","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Studienzentrum MVZ Dachau","city":"Dachau","state":"","country":"Germany","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Studiengesellschaft Mitteldeutschland GmbH","city":"Halle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Marien- und St. Annastiftskrankenhaus","city":"Ludwigshafen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Geomedical Egészségügyi Központ","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Komarom-Esztergom Varmegyei Szent Borbala Korhaz","city":"Tatabánya","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assuta Ashdod Medical Center","city":"Ashdod","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yitzhak Shamir Medical Center","city":"Tsrifin","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Careggi","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo dei Tintori","city":"Monza","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Sacro Cuore Don G. 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NZOZ Holsamed - oddział Libero","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Oslomed","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medrise Sp. z o.o.","city":"Lublin","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia PCM","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Siedlce","city":"Siedlce","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia SCM","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sonomed Sp. z o. o.","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"WSD MEDI","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Zamość","city":"Zamość","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","los-angeles-california","oxnard-california","englewood-colorado","miami-florida","miami-lakes-florida","atlanta-georgia","chicago-illinois","topeka-kansas","wyoming-michigan","st-louis-missouri","las-vegas-nevada","kingwood-texas","san-antonio-texas","ghent-belgium","leuven-belgium","roeselare-belgium","campinas-brazil","caxias-do-sul-brazil","curitiba-brazil","mar-lia-brazil","s-o-paulo-brazil","vit-ria-brazil","greenfield-park-canada","lethbridge-canada","london-canada","vaughan-canada","changsha-china","changzhou-china","guangzhou-china","hangzhou-china","huizhou-china","suzhou-china","wenzhou-china","xiamen-china","zhenjiang-china","berlin-germany","dachau-germany","halle-germany","ludwigshafen-germany","ulm-germany","budapest-hungary","tatab-nya-hungary","ashdod-israel","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tsrifin-israel","florence-italy","milan-italy","monza-italy","negrar-italy","roma-italy","rozzano-italy","katowice-poland","krakow-poland","lublin-poland","poznan-poland","siedlce-poland","szczecin-poland","warsaw-poland","zamo-poland"],"enrichment":{"headline":"Phase 2: testing Mirikizumab - Intravenous (IV) for Colitis, Ulcerative","inPlainEnglish":"Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. you would be assigned to the appropriate study prior to randomization to a treatment group.","whoItsFor":["Ages 18 Years to 80 Years","Must have an established diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) for at least 3 month duration, which includes clinical and endoscopic evidence of UC or CD and a histopathology report that supports a diagnosis of UC or CD","Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5-9 points and Endoscopic Subscore (ES) greater than or equal to (≥) 2, confirmed by the central reader and rectal bleeding (RB)≥1","Must have demonstrated an inadequate response, loss of response, or intolerance to at least one of the following: corticosteroids, immunomodulators, or an advanced therapy for UC or CD","Have screening laboratory test results within the protocol specified parameters"],"whoShouldSkip":["Must not have a current diagnosis of inflammatory bowel disease (IBD)-unclassified or primary sclerosing cholangitis","For UC - must not have a current diagnosis of CD","For CD - must not have a current diagnosis of UC","Must not have had or will need bowel resection or intestinal or intra-abdominal surgery as specified in the protocol","Must not have complications of UC or CD, including but not limited to stricture or stenosis (some exceptions allowed for CD) or short bowel syndrome","Must not have a significant uncontrolled illness that in the opinion of the investigator may compromise the participant's safety or interfere with interpretation of data","Must not have failed more than 5 approved advanced treatments for UC or CD with different mechanisms of action"],"whatHappens":"If you join, the listed intervention(s) are Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), or LY4395089. The registry lists allocation as randomized. Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.889Z"},{"nctId":"NCT07483099","title":"A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease","officialTitle":"A Phase 2, Multicenter, Randomized, Open-Label, Active-Controlled Study to Investigate LY4395089/Mirikizumab Co-administration Compared With Mirikizumab in Adults With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.","conditions":["Crohn Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4395089"},{"type":"DRUG","name":"Mirikizumab - Intravenous (IV)"},{"type":"DRUG","name":"Mirikizumab - Subcutaneous (SC)"}],"enrollment":60,"startDate":"2026-05-04","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all the inclusion criteria in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:\n\n* Participants taking glucagon-like peptide-1 (GLP-1) receptor agonists (RAs), GLP-1/glucose-dependent insulinotropic polypeptide (GIP) RAs, GLP-1/glucagon (Gcg) RAs, GLP-1/GIP/Gcg RAs, or similar medications for approved indications will be permitted to enroll provided they are on a stable dose at the time of screening\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the exclusion criteria in the IIBD master protocol, except the UC-specific criteria apply, or if any of the following criteria apply:\n\n* Must not have a hepatic disease\n* Must not have a history of any other bone disease that affects bone metabolism\n* Must not have had any of the following within the past 180 days before screening:\n\n  * acute myocardial infarction\n  * cerebrovascular incident\n  * hospitalization for unstable angina\n  * hospitalization due to congestive heart failure, or\n  * coronary revascularization\n* Must not have received or will need any other prohibited medications as specified in the protocol","locations":[{"facility":"Mayo Clinic in Arizona - Scottsdale","city":"Scottsdale","state":"Arizona","country":"United States","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Biopharma Informatic, LLC","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Om Research LLC","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Denver Gastroenterology","city":"Englewood","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Health Research - Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ezy Medical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Gastroenterology Associates - Peachtree Dunwoody","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Digestive Health Center","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center","city":"Wyoming","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"KAD Clinical Research","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vector Clinical Trials","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"One of a Kind Clinical Research Center - Kingwood","city":"Kingwood","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Star Research Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Maria Middelares","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent","city":"Ghent","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Delta vzw","city":"Roeselare","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Loema Instituto de Pesquisa Clinica","city":"Campinas","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Universidade de Caxias do Sul (FUCS)","city":"Caxias do Sul","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Digestivo de Curitiba","city":"Curitiba","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisa Clínica de Marília - CPCLIM","city":"Marília","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CPHosp Medicina, Ensino e Pesquisa (CPQuali)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CPCLIN","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"BR Trials - Ensaios Clinicos e Consultoria","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Hepatogastro JK","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEDOES","city":"Vitória","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre","city":"Greenfield Park","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Prairie Institute of Liver and Luminal Advanced Research Ltd (PILLAR)","city":"Lethbridge","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"London Digestive Disease Institute","city":"London","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tdda Inc.","city":"Vaughan","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhou Second People's Hospital","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Sun Yat-sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated hospital of Zhejiang University school of medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huizhou Central People's Hospital","city":"Huizhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Soochow University","city":"Suzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university","city":"Wenzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital Affiliated to Xiamen University","city":"Xiamen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Jiangsu University","city":"Zhenjiang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité Universitaetsmedizin Berlin - Campus Mitte","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Studienzentrum MVZ Dachau","city":"Dachau","state":"","country":"Germany","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Studiengesellschaft Mitteldeutschland GmbH","city":"Halle","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Marien- und St. Annastiftskrankenhaus","city":"Ludwigshafen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Geomedical Egészségügyi Központ","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Komarom-Esztergom Varmegyei Szent Borbala Korhaz","city":"Tatabánya","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assuta Ashdod Medical Center","city":"Ashdod","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yitzhak Shamir Medical Center","city":"Tsrifin","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Careggi","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale San Raffaele","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS San Gerardo dei Tintori","city":"Monza","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Sacro Cuore Don G. Calabria","city":"Negrar","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli","city":"Roma","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Humanitas","city":"Rozzano","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gyncentrum sp. z o.o. NZOZ Holsamed - oddział Libero","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne Oslomed","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medrise Sp. z o.o.","city":"Lublin","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia PCM","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Siedlce","city":"Siedlce","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Twoja Przychodnia SCM","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sonomed Sp. z o. o.","city":"Szczecin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"WSD MEDI","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś","city":"Warsaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"ETG Zamość","city":"Zamość","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"There may be multiple sites in this clinical trial. (Add \"This 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","los-angeles-california","oxnard-california","englewood-colorado","miami-florida","miami-lakes-florida","atlanta-georgia","chicago-illinois","topeka-kansas","wyoming-michigan","st-louis-missouri","las-vegas-nevada","kingwood-texas","san-antonio-texas","ghent-belgium","leuven-belgium","roeselare-belgium","campinas-brazil","caxias-do-sul-brazil","curitiba-brazil","mar-lia-brazil","s-o-paulo-brazil","vit-ria-brazil","greenfield-park-canada","lethbridge-canada","london-canada","vaughan-canada","changsha-china","changzhou-china","guangzhou-china","hangzhou-china","huizhou-china","suzhou-china","wenzhou-china","xiamen-china","zhenjiang-china","berlin-germany","dachau-germany","halle-germany","ludwigshafen-germany","ulm-germany","budapest-hungary","tatab-nya-hungary","ashdod-israel","haifa-israel","jerusalem-israel","petah-tikva-israel","ramat-gan-israel","tsrifin-israel","florence-italy","milan-italy","monza-italy","negrar-italy","roma-italy","rozzano-italy","katowice-poland","krakow-poland","lublin-poland","poznan-poland","siedlce-poland","szczecin-poland","warsaw-poland","zamo-poland"],"enrichment":{"headline":"Phase 2: testing LY4395089 for Crohn Disease","inPlainEnglish":"The main purpose of this study is to see how the safety and how well it works of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.","whoItsFor":["Ages 18 Years to 80 Years","Participants must meet all the who can join in the IIBD master protocol, except the UC-specific criteria. In addition, they must meet the criteria below:"],"whoShouldSkip":["Participants are excluded from the study if any of the"],"whatHappens":"If you join, the listed intervention(s) are LY4395089, Mirikizumab - Intravenous (IV), or Mirikizumab - Subcutaneous (SC). The registry lists allocation as randomized. The main purpose of this study is to see how the safety and how well it works of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 71 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.889Z"},{"nctId":"NCT07486817","title":"Beamion 44: A Study to Test How Well Zongertinib is Tolerated by People With Advanced Non-small Cell Lung Cancer With HER2 Mutations When Given in Combination With Chemotherapy With or Without Pembrolizumab","officialTitle":"Beamion 44: A Randomized, Open-label, Multi-center Phase IIa Platform Trial to Evaluate the Safety and Tolerability of Zongertinib Plus Platinum-based Doublet Chemotherapy With or Without Pembrolizumab (and Potential Other Combinations) in Treatment-naïve Patients With Locally Advanced/Metastatic Non-squamous NSCLC With Activating HER2 Mutations","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study. The purpose of this study is to find out how well a medicine called zongertinib is tolerated in people with this type of lung cancer, when combined with chemotherapy, with or without pembrolizumab. Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth.\n\nParticipants are put into two groups randomly, which means by chance. One group gets zongertinib tablets combined with platinum-based chemotherapy. The other group gets the same treatment plus an additional medicine called pembrolizumab. Chemotherapy and pembrolizumab are given as an infusion into a vein. Participants take zongertinib by mouth once a day, while chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years.\n\nPembrolizumab is given every 3 weeks for up to 2 years.\n\nThis study does not have a fixed duration. Participants can receive some of the study treatments for up to about 2 years and may continue to take zongertinib as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. Doctors regularly check the size of the tumor and whether it has spread. They also monitor participants' health and take note of any unwanted effects.","conditions":["Lung Cancer, Non-squamous, Non-small Cell"],"keywords":[],"interventions":[{"type":"DRUG","name":"Zongertinib"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":60,"startDate":"2026-06-04","completionDate":"2027-08-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF)\n2. Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)\n3. Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result\n4. An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status\n5. Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease\n6. Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1\n7. Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information\n8. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Tumors with targetable alterations with approved available therapy\n2. Presence or history of leptomeningeal disease\n3. Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start\n4. Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening\n5. Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and efficacy of the test drug\n6. Previous therapy with a HER2-directed agent\n7. History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization Further exclusion criteria apply.","locations":[{"facility":"Royal North Shore Hospital","city":"St Leonards","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cabrini Health","city":"Malvern","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital","city":"Murdoch","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Geriatric Medical Center","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTR Leon Berard","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"INS Curie","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Köln (AöR)","city":"Cologne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kindai University Hospital","city":"Osaka, Sakai","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Tokyo, Chuo-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"St James's University Hospital","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden Hospital, Chelsea","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Royal Marsden Hospital, Sutton","city":"Sutton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"18002430127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Occurrence of discontinuation and/or prolonged interruption (>7 days) of zongertinib due to treatment-related adverse events (AEs) in the first 2 cycles of treatment"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["st-leonards-australia","malvern-australia","murdoch-australia","guangzhou-china","shanghai-china","lyon-france","paris-france","cologne-germany","heidelberg-germany","osaka-sakai-japan","tokyo-chuo-ku-japan","seoul-south-korea","barcelona-spain","madrid-spain","seville-spain","leeds-united-kingdom","london-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Zongertinib for Lung Cancer, Non-squamous, Non-small Cell","inPlainEnglish":"This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread. People who have a tumor with a HER2 mutation and have not received previous treatment for their lung cancer can participate in the study.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous non-small cell lung cancer (NSCLC)","Documented activating human epidermal growth factor receptor 2 (HER2) mutation as per existing local lab result","An archival tumor tissue sample must be submitted to the central laboratory after randomization to retrospectively confirm the HER2 status","Patients who have not received any systemic treatment for unresectable, locally advanced or metastatic disease","Presence of at least one measurable non-Central Nervous System (CNS) lesion according to response evaluation criteria in solid tumors (RECIST) 1.1","Eligible to receive treatment with the selected platinum based doublet chemotherapy and pembrolizumab in accordance with the summary of product characteristics (SmPC)/Product Information","Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 Further who can join apply"],"whoShouldSkip":["Tumors with targetable alterations with approved available therapy","Presence or history of leptomeningeal disease","Radiotherapy within 4 weeks prior to treatment start with exception of palliative radiotherapy to regions other than the chest if completed at least 2 weeks prior to treatment start","Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to randomization or planned within 6 months after screening","Any history of or concomitant condition that, in the opinion of the investigator, would compromise the patient's ability to comply with the trial or interfere with the evaluation of the safety and how well it works of the test drug","Previous therapy with a HER2-directed agent","History or presence of cardiovascular abnormalities which are considered as clinically relevant by the investigator. Myocardial infarction, stroke, or pulmonary embolism within 6 months prior to randomization Further"],"whatHappens":"If you join, the listed intervention(s) are Zongertinib, Cisplatin, or Carboplatin. The registry lists allocation as randomized. This study is open to adults with a type of lung cancer called HER2-mutant non-squamous non-small cell lung cancer (NSCLC) that is advanced or has spread.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.654Z"},{"nctId":"NCT07486843","title":"Preventing Structural Damage in Early Psoriatic Arthritis","officialTitle":"Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain:\n\n\\- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.\n\nParticipants will be:\n\n* Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group.\n* HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.\n\nThe primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.","conditions":["Psoriatic Arthritis (PsA)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Amgevita 40Mg Solution for Injection"},{"type":"DRUG","name":"Methotrexate (Metoject® prefilled pen)"}],"enrollment":108,"startDate":"2026-03-16","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥18 years old\n* without severe deformity in MCPJ\n* with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks\n* with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI\\>1)\n* symptom duration ≤ 2 years\n\nExclusion Criteria:\n\n* on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)\n* limited in ability to perform usual self-care, vocational, and avocational activities\n* pregnancy\n* previous therapy with b/tsDMARDs\n* predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy\n* the presence of active inflammatory diseases other than PsA\n* active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis\n* history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)\n* contraindications to MTX or adalimumab","locations":[{"facility":"The Chinese University of Hong Kong, Prince of Wales Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Phase 4: testing Amgevita 40Mg Solution for Injection for Psoriatic Arthritis (PsA)","inPlainEnglish":"Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain: \\- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.","whoItsFor":["Ages 18 Years to any","without severe deformity in MCPJ","with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks","with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI\\>1)","symptom duration ≤ 2 years"],"whoShouldSkip":["on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)","limited in ability to perform usual self-care, vocational, and avocational activities","previous therapy with b/tsDMARDs","predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy","the presence of active inflammatory diseases other than PsA","active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis","history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)"],"whatHappens":"If you join, the listed intervention(s) are Amgevita 40Mg Solution for Injection, or Methotrexate (Metoject® prefilled pen). The registry lists allocation as randomized. Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 108 people at Hong Kong. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.274Z"},{"nctId":"NCT07487662","title":"TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk","officialTitle":"TACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk: A Multicenter, Multigroup, Randomized, Phase Ⅱ Exploratory Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sun Yat-sen University","sponsorClass":"OTHER","summary":"Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively. Currently, no standard perioperative treatment is recommended in domestic and international guidelines.\n\nRecently, data from a phase III clinical study, investigating neoadjuvant and adjuvant therapy with camrelizumab plus apatinib in resectable HCC patients at intermediate-to-high risk of recurrence, demonstrated that the neoadjuvant and adjuvant therapy combining targeted therapy and immunotherapy could significantly reduce postoperative recurrence. The median recurrence-free survival (RFS) in the target-immunotherapy group was 42.1 months, which was remarkably longer than 19.4 months in the surgery-alone group.\n\nLocal therapies (TACE, ablation) can induce immunogenic cell death of tumors and remodel the tumor microenvironment, thereby exerting synergistic effects with immunotherapy. This strategy is expected to further improve recurrence-free survival in HCC patients after surgery.\n\nThis clinical trial aims to explore the efficacy and tolerability of the following regimens compared with surgery alone:\n\n1. TACE or ablation combined with anti-CTLA-4 and anti-PD-1 immunotherapy;\n2. TACE or ablation combined with anti-CTLA-4 + anti-PD-1 + lenvatinib;\n3. Dual immunotherapy with anti-CTLA-4 and anti-PD-1;\n4. Anti-CTLA-4 + anti-PD-1 + lenvatinib. Efficacy differences between groups will be compared using Bayesian statistical methods based on non-informative priors.","conditions":["Hepato Cellular Carcinoma (HCC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"sintilimab"},{"type":"DRUG","name":"ipilimumab N01"},{"type":"DRUG","name":"Lenvatinib"},{"type":"PROCEDURE","name":"TACE"},{"type":"PROCEDURE","name":"ablation"}],"enrollment":105,"startDate":"2026-03-20","completionDate":"2028-03-19","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion;\n\n  3\\) No prior tumor-related treatment received;\n\n  4\\) At least one measurable target lesion according to the RECIST 1.1 criteria;\n\n  5\\) ECOG PS score of 0-1;\n\n  6\\) Liver function classification: Child-Pugh Class A;\n\n  7\\) Estimated survival time ≥ 12 weeks;\n\n  8\\) Hematological, liver, and renal functions meet the following criteria:\n  1. Hemoglobin concentration ≥ 90 g/L;\n  2. Neutrophil count ≥ 1.5 × 10⁹/L;\n  3. Platelet count ≥ 75 × 10⁹/L;\n  4. Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal);\n  5. AST and ALT \\< 5 × ULN; ALP \\< 4 × ULN;\n  6. Creatinine ≤ 1.5 × ULN;\n  7. INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN;\n  8. Serum albumin concentration ≥ 30 g/L;\n\n     9\\) Women of childbearing age must be excluded from pregnancy;\n\n     10\\) For patients with other concurrent malignant tumors, MDT discussion must confirm that the history and treatment history of other tumors will not interfere with the efficacy and safety evaluation of this study protocol;\n\n     11\\) Ability to understand and sign the informed consent form.\n\n     Exclusion Criteria:\n* 1\\) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis;\n\n  3\\) History of other complex surgeries within 6 weeks;\n\n  4\\) Prior history of organ transplantation;\n\n  5\\) Currently receiving treatment in other clinical trials;\n\n  6\\) Prior history of autoimmune diseases, inflammatory disorders (such as inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome (granulomatosis with polyangiitis, rheumatoid arthritis, etc.), except for the following cases: vitiligo or alopecia areata, hypothyroidism with stable condition after drug replacement therapy, chronic skin diseases that do not require systemic treatment, and celiac disease controllable by diet alone;\n\n  7\\) Prior history of allergy to anti-PD1 drugs, TKI or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies;\n\n  8\\) Uncontrollable intermittent recurrent diseases, including but not limited to: persistent infections (including tuberculosis), hypertension uncontrollable by drugs (\\> 140/90 mmHg), interstitial lung disease, severe chronic gastrointestinal diseases complicated with diarrhea, mental illness or social disorders that cannot comply with clinical research requirements, factors with high risk of side effects, and inability to sign the informed consent form;\n\n  9\\) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration;\n\n  10\\) Untreated active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 5000 copies/mL (1000 IU/mL) or higher than the lower limit of detection, whichever is higher); for subjects with hepatitis B, anti-hepatitis B virus treatment is required during the study treatment; active hepatitis C subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);\n\n  11\\) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year;\n\n  12\\) Primary immunodeficiency disease;\n\n  13\\) Prior positive HIV test or acquired immunodeficiency syndrome (AIDS);\n\n  14\\) Use of immunosuppressive drugs within 14 days before the start of study treatment. The following situations are exempt:\n  1. Intranasal, inhaled, topically used steroids or local steroid injections;\n  2. Systemic application of corticosteroids not exceeding the physiological dose (e.g., 10 mg/day prednisone or its equivalent);\n  3. Steroid application for the treatment of allergic reactions;\n\n     15\\) Vaccination with live-attenuated vaccines within 30 days before the start of study treatment. Note: Live-attenuated vaccines should also be avoided during the study treatment and within 30 days after the end of treatment;\n\n     16\\) Receipt of systemic immunostimulant treatment within the prior 4 weeks;\n\n     17\\) Prior history of severe systemic diseases, including: myocardial infarction or unstable angina pectoris, hypertensive crisis or hypertensive encephalopathy, congestive heart failure of NYHA Class II or above, unstable symptomatic arrhythmia requiring drug intervention, severe vascular disease or symptomatic peripheral vascular disease, occurring within 12 months before the start of study treatment;\n\n     18\\) History of coagulative, hemorrhagic or thrombotic diseases within 12 months before the start of study treatment;\n\n     19\\) Severe, irreversible trauma, ulcers or fractures;\n\n     20\\) Pregnant or lactating women, or subjects planning to have children during the trial period;\n\n     21\\) Dependent on parenteral nutrition to maintain life;\n\n     22\\) Other acute or chronic diseases, mental and psychological diseases, etc., which are not suitable for participating in this study, as judged by the researcher.","locations":[{"facility":"The First Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ming Kuang","phone":"+86 020-87755766","email":"kuangm@mail.sysu.edu.cn"}],"primaryOutcomes":["1-year recurrence-free survival rate"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: testing sintilimab for Hepato Cellular Carcinoma (HCC)","inPlainEnglish":"Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide. The recurrence rate after curative resection for early-stage HCC remains extremely high, with 2-year and 5-year recurrence rates reaching 50% and 70%, respectively.","whoItsFor":["Ages 18 Years to 75 Years","1\\) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion;","3\\) No prior tumor-related treatment received;","4\\) At least one measurable target lesion according to the RECIST 1.1 criteria;","5\\) ECOG PS score of 0-1;","6\\) Liver function classification: Child-Pugh Class A;","7\\) Estimated survival time ≥ 12 weeks;","8\\) Hematological, liver, and renal functions meet the following criteria:"],"whoShouldSkip":["1\\) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis;","3\\) History of other complex surgeries within 6 weeks;","4\\) Prior history of organ transplantation;","5\\) Currently receiving treatment in other clinical trials;","7\\) Prior history of allergy to anti-PD1 drugs, TKI or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies;","9\\) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration;","11\\) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year;"],"whatHappens":"If you join, the listed intervention(s) are sintilimab, ipilimumab N01, or Lenvatinib. The registry lists allocation as randomized. Hepatocellular carcinoma (HCC) is one of the leading causes of cancer-related mortality worldwide.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 105 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.632Z"},{"nctId":"NCT07488520","title":"Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire","officialTitle":"Integrating Point of Care Testing (POCT) For Newborn Screening and Early Care for Sickle Cell Disease in Yopougon, Côte d'Ivoire","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Swiss Tropical & Public Health Institute","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes.\n\nThe main questions it aims to answer are:\n\n* Does the intervention lower the number of SCD-related illnesses?\n* Does the intervention lower the illness incidence defined as seeking health care at any health facility - with or without treatment - for any episode related to a SCD related illness?\n* Does the intervention lower all-cause death rate (at the end of 1, 2, 3 and 3.5 years of follow-up)?\n\nResearchers will compare the multifaceted intervention results with those of historical data (based on erratic SCD testing and treatment) from the region.\n\nParticipants will undergo a SCD screening test using the Gazelle Multispectral platform and if positive they will undergo confirmatory testing with HemoTypeSC™. Participants with SCD will receive early comprehensive clinical interventions i.e. standard administration of antibacterial and antimalarial prophylaxis, vaccinations for pneumococcal and Haemophilus influenzae type b (Hib), hydroxyurea, parental education about the need for regular and, if necessary, urgent medical care.","conditions":["Sickle Cell Disease (SCD)"],"keywords":["Sickle cell disease","Newborn Screening","Early Care for Sickle Cell Disease","Point of care testing"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions"}],"enrollment":120,"startDate":"2026-07-27","completionDate":"2029-12","sex":"ALL","minAge":"0 Months","maxAge":"6 Months","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Children aged 0 - 6 months old identified at selected health facilities within the study area\n2. Babies whose age plus the gestation period reaches 37 weeks or more\n3. Children who did not receive a blood transfusion within the past 90 days\n4. Children whose parents or guardians have consented to participate in the study by signing a consent form\n\nExclusion Criteria:\n\n1. Children already diagnosed with SCD\n2. Children that are participating in another clinical research project\n3. Children that are critically ill and require emergency treatment","locations":[{"facility":"Yopougon Millionnaire extension health center","city":"Abidjan","state":"","country":"Côte d’Ivoire","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yopougon SCD Center of Excellence","city":"Yopougon","state":"","country":"Côte d’Ivoire","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Acellam Charles Abongomera, MD, MPH, PhD","phone":"+41612848629","email":"charles.abongomera@swisstph.ch"},{"name":"Benjamin Koudou, PhD","phone":"+2250777205263","email":"guibehi.koudou@csrs.ci"}],"primaryOutcomes":["The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:","The clinical outcomes of implementing a novel multifaceted intervention composed of a Gazelle SCD POCT, and early initiation of comprehensive SCD care are:"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["abidjan-c-te-divoire","yopougon-c-te-divoire"],"enrichment":{"headline":"Phase 4: Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions for Sickle Cell Disease (SCD)","inPlainEnglish":"The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes. The main questions it aims to answer are: * Does the intervention lower the number of SCD-related illnesses?","whoItsFor":["Ages 0 Months to 6 Months","Children aged 0 - 6 months old identified at selected health facilities within the study area","Babies whose age plus the gestation period reaches 37 weeks or more","Children who did not receive a blood transfusion within the past 90 days","Children whose parents or guardians have consented to participate in the study by signing a consent form"],"whoShouldSkip":["Children already diagnosed with SCD","Children that are participating in another clinical research project","Children that are critically ill and require emergency treatment"],"whatHappens":"If you join, the listed intervention(s) are Gazelle-Multispectral point of care testing for newborn sickle cell disease screening; and initiation of early comprehensive clinical interventions. The registry lists allocation as na. The goal of this clinical trial is to learn if a multifaceted intervention composed of Gazelle-Multispectral sickle cell disease (SCD) point of care testing (POCT) and early initiation of comprehensive SCD care in children with SCD disease aged 0 - 6 months can improve their clinical outcomes.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 120 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.846Z"},{"nctId":"NCT07489495","title":"A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)","officialTitle":"A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).\n\nA standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone.\n\nThe goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.","conditions":["Carcinoma, Renal Cell"],"keywords":[],"interventions":[{"type":"DRUG","name":"Belzutifan"},{"type":"DRUG","name":"Zanzalintinib"},{"type":"DRUG","name":"Placebo"}],"enrollment":758,"startDate":"2026-04-09","completionDate":"2030-11-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)\n* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)\n* Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy\n\nExclusion Criteria:\n\nFor exclusion criteria: The main exclusion criteria include but are not limited to the following:\n\n* Has any of the following: a pulse oximeter reading \\<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention\n* Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization\n* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram\n* Has had major surgery within 8 weeks before randomization\n* Has current pneumonitis/interstitial lung disease\n* Has a history of human immunodeficiency virus infection\n* Has Hepatitis B or Hepatitis C virus infection\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has a history of solid organ transplant\n* Has not adequately recovered from major surgery or has ongoing surgical complications","locations":[{"facility":"City of Hope Comprehensive Cancer Center ( Site 0129)","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Lennar Foundation Cancer Center ( Site 0142)","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Louisville, James Graham Brown Cancer Center ( Site 0133)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104)","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center ( Site 0139)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute ( Site 0135)","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer and Hematology Centers ( Site 0123)","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine ( Site 0114)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 0108)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Health System Morristown Medical Center ( Site 0109)","city":"Morristown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center ( Site 0126)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The West Clinic, P.C. ( Site 0115)","city":"Germantown","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center ( Site 0119)","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Oncologico Korben ( Site 0254)","city":"CABA","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires ( Site 0253)","city":"Ciudad de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)","city":"Río Cuarto","state":"Córdoba Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque ( Site 0251)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Oncología de Rosario ( Site 0257)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0252)","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Oncológico Riojano Integral ( Site 0256)","city":"La Rioja","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"COE (Centro Oncológico de Excelencia) ( Site 0259)","city":"San Juan","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University ( Site 2700)","city":"Macquarie University","state":"New South Wales","country":"Australia","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital ( Site 2703)","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre ( Site 2702)","city":"Melbourne","state":"Victoria","country":"Australia","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital ( Site 2704)","city":"Murdoch","state":"Western Australia","country":"Australia","status":"SUSPENDED","lat":null,"lon":null},{"facility":"CEDOES ( Site 0303)","city":"Vitória","state":"Espírito Santo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto do Câncer e Transplante de Curitiba ( Site 0300)","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra o Câncer ( Site 0307)","city":"Natal","state":"Rio Grande do Norte","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital Cancer Centre ( Site 0003)","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0001)","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"IC La Serena Research ( Site 0405)","city":"La Serena","state":"Coquimbo Region","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Puerto Montt ( Site 0404)","city":"Port Montt","state":"Los Lagos Region","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Arturo Lopez Perez ( Site 0401)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradfordhill ( Site 0400)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"ONCOCENTRO APYS ( Site 0403)","city":"Viña del Mar","state":"Valparaiso","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Masarykuv onkologicky ustav ( Site 0903)","city":"Brno","state":"Brno-mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice Ostrava ( Site 0904)","city":"Ostrava","state":"Ostrava Mesto","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice Hradec Kralove ( Site 0902)","city":"Hradec Králové","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice Olomouc ( Site 0901)","city":"Olomouc","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakulti poliklinika ( Site 0906)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fakultni nemocnice v Motole ( Site 0900)","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herlev Hospital ( Site 1002)","city":"Herlev","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aarhus Universitetshospital, Skejby ( Site 1001)","city":"Aarhus","state":"Central Jutland","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Odense Universitets Hospital ( Site 1000)","city":"Odense","state":"Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Antoine Lacassagne ( Site 1209)","city":"Nice","state":"Alpes-Maritimes","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Europeen Marseille ( Site 1216)","city":"Marseille","state":"Bouches-du-Rhone","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)","city":"Toulouse","state":"Haute-Garonne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Angers ( Site 1204)","city":"Angers","state":"Maine-et-Loire","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)","city":"Le Mans","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Saint-Etienne ( Site 1202)","city":"Saint Priest En Jarez","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy ( Site 1214)","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Augsburg ( Site 1316)","city":"Augsburg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"klinikum rechts der isar der technischen universität münchen ( Site 1315)","city":"Munich","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Jena ( Site 1313)","city":"Jena","state":"Thuringia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alexandra General Hospital of Athens ( Site 1400)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolitan Hospital ( Site 1402)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 1600)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Meir Medical Center. ( Site 1603)","city":"Kfar Saba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rabin Medical Center ( Site 1602)","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 1601)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) \"Dino Amadori\" ( Site 1809)","city":"Meldola","state":"Emilia-Romagna","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas ( Site 1808)","city":"Rozzano","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Oncologico Veneto IRCCS ( Site 1806)","city":"Catselfranco Veneto","state":"Padova","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Careggi ( Site 1807)","city":"Florence","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Policlinico di Bari ( Site 1802)","city":"Bari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"AO Santa Maria della Misericordia ( Site 1805)","city":"Perugia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Nazionale Tumori Regina Elena ( Site 1804)","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maastricht UMC+ ( Site 1901)","city":"Maastricht","state":"Limburg","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1903)","city":"Schiedam","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haga Ziekenhuis locatie Leyweg ( Site 1906)","city":"The Hague","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIDPORT Sp. z o.o. ( Site 2118)","city":"Skórzewo","state":"Greater Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia MCM Krakow ( Site 2115)","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mazowiecki Szpital Wojewódzki im. Sw. Jana Pawla II w Siedlcach Sp. z o.o. ( Site 2102)","city":"Siedlce","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"MTZ Clinical Research Powered by Pratia ( Site 2107)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)","city":"Gliwice","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System ( Site 2903)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center ( Site 2901)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center ( Site 2902)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen del Rocio ( Site 2306)","city":"Seville","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia - L'Hospitalet ( Site 2305)","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d Hebron ( Site 2303)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Insular de Gran Canaria ( Site 2308)","city":"Las Palmas","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 2300)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundación Instituto Valenciano de Oncología ( Site 2307)","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri ( Site 2500)","city":"Sıhhiye","state":"Ankara","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adana Medical Park Seyhan Hastanesi ( Site 2505)","city":"Adana","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ankara University Health Practice and Research Hospitals ( Site 2506)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trakya University Medical Faculty Hospital ( Site 2502)","city":"Edirne","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koc Universitesi Hastanesi ( Site 2501)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ege Universitesi Hastanesi ( Site 2503)","city":"Izmir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrookes Hospital ( Site 2605)","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western General Hospital ( Site 2608)","city":"Edinburgh","state":"Edinburgh, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Beatson West of Scotland Cancer Centre ( Site 2602)","city":"Glasgow","state":"Glasgow City","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary ( Site 2604)","city":"Leicester","state":"Leicestershire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Vernon Hospital ( Site 2607)","city":"Northwood","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie Hospital NHS Foundation Trust ( Site 2601)","city":"Withington","state":"Manchester","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Birmingham NHS Foundation Trust ( Site 2610)","city":"Birmingham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre ( Site 2612)","city":"Cardiff","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Southampton ( Site 2606)","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-free Survival (PFS)","Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","irvine-california","marietta-georgia","louisville-kentucky","boston-massachusetts","grand-rapids-michigan","st-louis-missouri","hackensack-new-jersey","morristown-new-jersey","new-york-new-york","germantown-tennessee","dallas-texas","caba-argentina","ciudad-de-buenos-aires-argentina","mar-del-plata-argentina","r-o-cuarto-argentina","rosario-argentina","la-rioja-argentina","san-juan-argentina","macquarie-university-australia","woolloongabba-australia","melbourne-australia","murdoch-australia","vit-ria-brazil","curitiba-brazil","natal-brazil","ribeir-o-preto-brazil","s-o-jos-do-rio-preto-brazil","ottawa-canada","qu-bec-canada","la-serena-chile","port-montt-chile","santiago-chile","vi-a-del-mar-chile","brno-czechia","ostrava-czechia","hradec-kr-lov-czechia","olomouc-czechia","prague-czechia","herlev-denmark","aarhus-denmark","odense-denmark","nice-france","marseille-france","toulouse-france","angers-france","le-mans-france","saint-priest-en-jarez-france","villejuif-france","augsburg-germany","munich-germany","jena-germany","berlin-germany","athens-greece","haifa-israel","kfar-saba-israel","petah-tikva-israel","ramat-gan-israel","meldola-italy","rozzano-italy","catselfranco-veneto-italy","florence-italy","bari-italy","bologna-italy","milan-italy","perugia-italy","roma-italy","maastricht-netherlands","amsterdam-netherlands","schiedam-netherlands","the-hague-netherlands","sk-rzewo-poland","krakow-poland","siedlce-poland","warsaw-poland","gliwice-poland","seoul-south-korea","seville-spain","lhospitalet-de-llobregat-spain","madrid-spain","barcelona-spain","las-palmas-spain","valencia-spain","s-hhiye-turkey-t-rkiye","adana-turkey-t-rkiye","ankara-turkey-t-rkiye","edirne-turkey-t-rkiye","istanbul-turkey-t-rkiye","izmir-turkey-t-rkiye","cambridge-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","leicester-united-kingdom","northwood-united-kingdom","withington-united-kingdom","birmingham-united-kingdom","cardiff-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Belzutifan for Carcinoma, Renal Cell","inPlainEnglish":"Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)","Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)","Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Belzutifan, Zanzalintinib, or Placebo. The registry lists allocation as randomized. Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 758 people at 111 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.896Z"},{"nctId":"NCT07489651","title":"RE104 Safety and Efficacy Study in Generalized Anxiety Disorder","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of RE104 for Injection in the Treatment of Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Reunion Neuroscience Inc","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to placebo.","conditions":["Generalized Anxiety Disorder"],"keywords":["GAD"],"interventions":[{"type":"DRUG","name":"RE104 for Injection"},{"type":"DRUG","name":"Placebo"}],"enrollment":160,"startDate":"2026-04-20","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has Generalized Anxiety Disorder as defined by DSM-5-TR\n* If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant.\n* Is willing and able to comply with the conditions and requirements of the study\n\nExclusion Criteria:\n\n* Has a significant risk of suicide\n* Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder\n* Has other concurrent psychiatric disorders that is the primary disorder.\n* Has other medically significant conditions rendering unsuitability for the study\n* Has used or will need to use prohibited medications or therapies\n* Has a known sensitivity or intolerance to study intervention or potential rescue medications","locations":[{"facility":"University of Alabama (UAB) Clinical Research Unit (CRU)","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lighthouse Psychiatry","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Preferred Research Partners, Inc.","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kadima Neuropsychiatry Institute","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Open Mind Therapeutics","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TRIP Clinic at Psychedelic Science Institute","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Clinical Research, Inc.","city":"Lauderhill","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of South Florida","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel iResearch, LLC","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evergreen Clinical Trials","city":"Norcross","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel iResearch, LLC","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uptown Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Medical Center - Columbus","city":"Novi","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Research Group","city":"Saint Charles","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNM Research Program Psychedelic Therapies","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU-H+C Clinical and Translational Science Institute","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Behavioral Clinical Research, Inc.","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summit Headlands LLC","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban Research Associates","city":"West Chester","state":"Pennsylvania","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Austin Clinical Trial Partners","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BioBehavioral Research Austion","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aim Trials, LLC","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Clinical Research","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inner Space State Street","city":"Orem","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mark Pollack Chief Medical Officer, M.D.","phone":"1-888-880-REUN","email":"info@reunionneuro.com"}],"primaryOutcomes":["RE104 when administered as a single 30 mg dose or as two 30 mg doses 3 weeks apart versus placebo change from Baseline at Week 4 in Hamilton Anxiety Rating Scale (HAM-A) total score"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","gilbert-arizona","little-rock-arkansas","garden-grove-california","la-jolla-california","san-francisco-california","santa-monica-california","lauderhill-florida","tampa-florida","atlanta-georgia","decatur-georgia","norcross-georgia","savannah-georgia","chicago-illinois","novi-michigan","saint-charles-missouri","albuquerque-new-mexico","new-york-new-york","chapel-hill-north-carolina","north-canton-ohio","portland-oregon","philadelphia-pennsylvania","west-chester-pennsylvania","austin-texas","plano-texas","draper-utah","orem-utah"],"enrichment":{"headline":"Phase 2: testing RE104 for Injection for Generalized Anxiety Disorder","inPlainEnglish":"This study wants to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 74 Years","Has Generalized Anxiety Disorder as defined by DSM-5-TR","If female is not pregnant or planning to become pregnant. If male is not planning to make a partner pregnant","Is willing and able to comply with the conditions and requirements of the study"],"whoShouldSkip":["Has a significant risk of suicide","Has an active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder","Has other concurrent psychiatric disorders that is the primary disorder","Has other medically significant conditions rendering unsuitability for the study","Has used or will need to use prohibited medications or therapies","Has a known sensitivity or intolerance to study intervention or potential rescue medications"],"whatHappens":"If you join, the listed intervention(s) are RE104 for Injection, or Placebo. The registry lists allocation as randomized. This study wants to determine if treatment with a single and/or repeat dose of RE104 for Injection reduces anxiety symptoms in participants with Generalized Anxiety Disorder (GAD) as compared to dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.353Z"},{"nctId":"NCT07490964","title":"Polycystic Ovary Syndrome in Type 1 Diabetes","officialTitle":"Pathogenesis of Functional Hyperandrogenism in Women With Type 1 Diabetes Mellitus: From Genetic-molecular Mechanisms to Clinical Phenotype.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","sponsorClass":"OTHER","summary":"BACKGROUND Functional ovarian hyperandrogenism, including the polycystic ovary syndrome (PCOS), is very prevalent in women with type 1 diabetes (T1D). The pathogenic mechanisms of this association remain unclear.\n\nHYPOTHESIS Individual factors expose or protect women with T1D to/from the development of androgen excess and PCOS. Such androgen excess in women with T1D may increase their cardiometabolic risk.\n\nMAIN OBJECTIVE Unveiling the pathogenic mechanisms behind functional hyperandrogenism in women with T1D from a sex/gender-medicine and sexual dimorphism perspective.\n\nMATERIAL AND METHOS We have designed a cross-sectional comparative clinical study, including 5 groups of study subjects with 12 participans per group:\n\ni) Women with T1D \\& PCOS. ii) Women with T1D without PCOS. iii) Men with T1D and normal gonadal function. iv) Women with PCOS without diabetes mellitus v) Non-hyperandrogenic control women without T1D. All groups will show similar age and body mass index. T1D groups will be matched for duration of disease.\n\nOUTCOMES 1.1 Insulin sensitivity (hyperinsulinaemic euglycaemic clamping). 1.2 Body composition (dual-energy x-ray absorptiometry, bioelectrical impedance analysis \\& sonographic studies).\n\n1.3 Ovarian and adrenal steroidogenesis. 2.1 Differential pattern in genetic variants related with insulin signalling and response, inflammation, adiposity, gonadal function, steroidogenesis, and PCOS itself by whole exome sequencing.\n\n2.2 Microbiopsy studies in deep subcutaneous adipose tissue and skeletal muscle tissue: 2.2.1 Differential DNA methylation patterns in genes associated with PCOS. 2.2.2 Differential transcriptomic pattern in genes associated with PCOS.\n\n2.2.3 Differential proteomic patterns in adipose and muscle tissues. 3. Interaction between T1D and PCOS on parameters of metabolic control (intersticial blood glucose monitoring) and morbidities associated with T1D itself.","conditions":["Type 1 Diabetes Mellitus","Polycystic Ovary Syndrome (PCOS)"],"keywords":["Hyperandrogenism","Type 1 diabetes","Pathogenesis","Steroidogenesis","Insulin resistance","Body composition","Genetics","Epigenetics"],"interventions":[{"type":"OTHER","name":"Type 1 diabetes mellitus"},{"type":"OTHER","name":"Elevated circulating androgen levels"},{"type":"OTHER","name":"Sex dimorphism"}],"enrollment":60,"startDate":"2026-04-01","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"1. Non--hyperandrogenic women with type 1 diabetes INCLUSION CRITERIA\n\n   * Premenopausal women between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n   * Menarche at least three years prior to study entry. EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Pregnancy or lactation.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n2. Women with type 1 diabetes and polycystic ovary syndrome INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n   * Menarche at least three years prior to study entry.\n   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.\n\n   EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Pregnancy/lactation.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease. reatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n3. Men with T1D and normal gonadal function of similar age, BMI, and duration of diabetes.\n\n   INCLUSION CRITERIA\n   * Age between 18 and 45 years old.\n   * Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency.\n   * Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion).\n   * Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry.\n\n   EXCLUSION CRITERIA\n   * Honeymoon period of T1D.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia.\n   * Diagnosis of male hypogonadism.\n4. Women with PCOS of similar age and BMI. INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Menarche at least three years prior to study entry.\n   * PCOS diagnosis based on the 2012 American NIH consensus criteria, including the Rotterdam and AE-PCOS.\n\n   EXCLUSION CRITERIA\n   * Pregnancy/lactation.\n   * Previously known carbohydrate metabolism abnormalities (prediabetes or type 2 diabetes).\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.\n5. Non-hyperandrogenic control women with regular menses of similar age and BMI. INCLUSION CRITERIA\n\n   * Women between 18 and 45 years old.\n   * Menarche at least three years prior to study entry.\n   * Presence of regular menses.\n   * Lack of signs or symptoms of functional hyperandrogenism. EXCLUSION CRITERIA\n   * Pregnancy/lactation.\n   * Previously known carbohydrate metabolism disturbances.\n   * Thyroid hormone dysfunction or hyperprolactinaemia.\n   * Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism.\n   * Diagnosis of other serious chronic disease.\n   * Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study.","locations":[{"facility":"Department of Endocrinology and Clinical Nutrition, Hospital Universitario Ramón y Cajal, Carretera de Colmenar Viejo, Km 9.1, 28034-Madrid (Spain)","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Manuel Luque-Ramírez, Principal Investigator, PhD, MD, MBA","phone":"+34 913368000","email":"manuel.luque@salud.madrid.org"}],"primaryOutcomes":["Differences in insulin sensitivity between study subgroups","Fat mass percentage","Phase angle 50 KHz","Peritoneum-vertebral column fat thickness","Trunk fat mass %","Differences in ovarian and adrenal steroidogenesis between study subgroups"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["madrid-spain"],"enrichment":{"headline":"Not a traditional drug phase: Type 1 diabetes mellitus for Type 1 Diabetes Mellitus","inPlainEnglish":"BACKGROUND Functional ovarian hyperandrogenism, including the polycystic ovary syndrome (PCOS), is very prevalent in women with type 1 diabetes (T1D). The pathogenic mechanisms of this association remain unclear.","whoItsFor":["Ages 18 Years to 45 Years","Non--hyperandrogenic women with type 1 diabetes","Premenopausal women between 18 and 45 years old","Diagnosis of type 1a diabetes at least 12 months before inclusion in the study, confirmed by positive autoimmunity and complete insulin deficiency","Treatment with subcutaneous insulin therapy (multiple doses or continuous infusion)","Availability of metabolic control data (continuous interstitial blood glucose monitoring) at least in the month prior to study entry","Menarche at least three years prior to study entry"],"whoShouldSkip":["Honeymoon period of T1D","Pregnancy or lactation","Thyroid hormone dysfunction or hyperprolactinaemia","Diagnosis of non-classical congenital adrenal hyperplasia or other secondary causes of hyperandrogenism","Diagnosis of other serious chronic disease","Treatment with oral contraceptives or glucocorticoid therapy in the 3 months prior to inclusion in the study","Women with type 1 diabetes and polycystic ovary syndrome who can join"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at Madrid. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.791Z"},{"nctId":"NCT07491380","title":"Validation of Capillary Microsampling for Therapeutic Drug Monitoring of CDK4/6 Inhibitors in Breast Cancer Patients (TDHOME)","officialTitle":"Validation of Capillary Microsampling for Therapeutic Drug Monitoring (TDM) of CDK4/6 Inhibitors in Breast Cancer Patients","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Institut Curie","sponsorClass":"OTHER","summary":"This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.","conditions":["Breast Cancer"],"keywords":["Capillary microsampling, therapeutic drug monitoring, ribociclib, abemaciclib, palbociclib, breast cancer, pharmacokinetics, personalized treatment"],"interventions":[{"type":"OTHER","name":"Capillary samples using the VAMS Mitra device"}],"enrollment":90,"startDate":"2026-06-23","completionDate":"2028-01-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult patients (≥ 18 years) with breast cancer.\n2. Patients currently receiving ribociclib, abemaciclib, or palbociclib.\n3. Patients capable of performing capillary sampling (with or without assistance).\n4. Patient information and signing of informed consent.\n5. Patient ability to comply with protocol requirements.\n6. Patients covered by a health insurance system.\n\nExclusion Criteria:\n\n1. Patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent.\n2. Persons deprived of their liberty or under guardianship.","locations":[{"facility":"Institut Curie Paris","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Curie","city":"Saint-Cloud","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marie-Emmanuelle Legrier","phone":"0033156245649","email":"drci.promotion@curie.fr"}],"primaryOutcomes":["Measurement of the concordance between the drug concentrations obtained from capillary and venous sampling."],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["paris-france","saint-cloud-france"],"enrichment":{"headline":"Not a traditional drug phase: Capillary samples using the VAMS Mitra device for Breast Cancer","inPlainEnglish":"This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.","whoItsFor":["Ages 18 Years to any","Adult patients (≥ 18 years) with breast cancer","Patients currently receiving ribociclib, abemaciclib, or palbociclib","Patients capable of performing capillary sampling (with or without assistance)","Patient ability to comply with protocol requirements","Patients covered by a health insurance system"],"whoShouldSkip":["Persons deprived of their liberty or under guardianship"],"whatHappens":"If you join, the listed intervention(s) are Capillary samples using the VAMS Mitra device. The registry lists allocation as na. This is a prospective validation study, multicenter, open-label, single-arm study, evaluating the concordance between capillary microsampling (using the VAMS Mitra device) and venous sampling in patients undergoing CDK4/6 therapy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.731Z"},{"nctId":"NCT07491718","title":"Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy","officialTitle":"Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Edinburgh","sponsorClass":"OTHER","summary":"The goal of this research study is to further understand the physiological mechanisms involved in a heart condition called takotsubo cardiomyopathy, also known as broken heart syndrome. Furthermore, the investigators will be assessing the effects different cardiac medications have on these physiological mechanisms.\n\nThis will be achieved by performing cardiac MRI scans using a special dye called manganese. Manganese uptake in the heart is altered in patients with takotsubo cardiomyopathy. The investigators will study the effects that different cardiac medications have on manganese uptake.","conditions":["Takotsubo Cardiomyopathy"],"keywords":["Takotsubo","Broken heart syndrome","Stress cardiomyopathy","Manganese"],"interventions":[{"type":"DRUG","name":"Bisoprolol"},{"type":"DRUG","name":"Valsartan"},{"type":"DRUG","name":"sacubitril/ valsartan"},{"type":"DRUG","name":"Dapagliflozin (10mg Tab)"},{"type":"DRUG","name":"No medications"}],"enrollment":100,"startDate":"2025-08-08","completionDate":"2028-08-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Males and females \\>18 years of age\n* Clinical presentation of takotsubo cardiomyopathy\n* Have capacity to give formal consent\n\nExclusion Criteria:\n\n* Unable to tolerate or contraindication to magnetic resonance imaging\n* Renal failure (estimated glomerular filtration rate \\<30 mL/min/1.73 m2) - this would be assessed by performing a blood test\n* Prior history of cardiomyopathy\n* Current pregnancy\n* Weight greater than 250kg\n* Severe asthma for study 1 (given Bisoprolol is contraindicated in this condition)\n* Type 1 diabetes mellitus for study 2 (given Dapaglifozin is contraindicated in this population)\n* Significant hypotension (given the medications prescribed as part of the study can also cause hypotension as a side effect)\n* Significant bradycardia for study 1 (given Bisoprolol can exacerbate any pre-existing significant bradycardia)\n* Prescribed Digoxin (this medication interacts with the Manganese)\n* Unable to give formal consent","locations":[{"facility":"University of Edinburgh","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Ramsay","phone":"01316501000","email":"jramsay5@ed.ac.uk"}],"primaryOutcomes":["Left ventricular myocardial manganese uptake."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["dapagliflozin"],"locationSlugs":["edinburgh-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Bisoprolol for Takotsubo Cardiomyopathy","inPlainEnglish":"The goal of this research study is to further understand the physiological mechanisms involved in a heart condition called takotsubo cardiomyopathy, also known as broken heart syndrome. Furthermore, the investigators will be assessing the effects different cardiac medications have on these physiological mechanisms.","whoItsFor":["Ages 18 Years to any","Males and females \\>18 years of age","Clinical presentation of takotsubo cardiomyopathy","Have capacity to give formal consent"],"whoShouldSkip":["Unable to tolerate or contraindication to magnetic resonance imaging","Renal failure (estimated glomerular filtration rate \\<30 mL/min/1.73 m2) - this would be assessed by performing a blood test","Prior history of cardiomyopathy","Weight greater than 250kg","Severe asthma for study 1 (given Bisoprolol is contraindicated in this condition)","Type 1 diabetes mellitus for study 2 (given Dapaglifozin is contraindicated in this population)","Significant hypotension (given the medications prescribed as part of the study can also cause hypotension as a side effect)"],"whatHappens":"If you join, the listed intervention(s) are Bisoprolol, Valsartan, or sacubitril/ valsartan. The registry lists allocation as randomized. The goal of this research study is to further understand the physiological mechanisms involved in a heart condition called takotsubo cardiomyopathy, also known as broken heart syndrome.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Edinburgh. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.973Z"},{"nctId":"NCT07491913","title":"Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission","officialTitle":"Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Marmara University","sponsorClass":"OTHER","summary":"Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches. Biologic therapies such as tumor necrosis factor inhibitors and tocilizumab are commonly used in patients with refractory or relapsing disease. However, there is limited evidence regarding the optimal duration of biologic therapy and the safety of treatment discontinuation in patients who achieve sustained remission.\n\nThis prospective study aims to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have been in long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during this period will discontinue biologic therapy and will be followed for 12 months.\n\nThe primary objective of the study is to determine the proportion of patients who maintain remission after biologic treatment withdrawal. Secondary objectives include evaluating the rate and timing of disease relapse during the tapering phase and the post-withdrawal follow-up period.","conditions":["Takayasu Arteritis"],"keywords":["Takayasu arteritis","Biologic therapy withdrawal","Treatment discontinuation","TNF inhibitors","Tocilizumab","Large vessel vasculitis"],"interventions":[{"type":"DRUG","name":"Tociliuzumab"},{"type":"DRUG","name":"Infliximab"},{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Certolizumab Pegol"}],"enrollment":40,"startDate":"2025-06-15","completionDate":"2027-12-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of Takayasu arteritis according to the 2022 American College of Rheumatology/EULAR classification criteria\n* Treatment with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years\n* Sustained clinical, laboratory, and radiologic remission\n* No change in treatment during the previous 12 months\n* No glucocorticoid use within the previous 6 months\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)\n* Inability to attend scheduled follow-up visits after treatment tapering and discontinuation\n* Pregnancy or planning pregnancy during the study period","locations":[{"facility":"Marmara University Pendik Training and Research Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fatma Alibaz-Oner, MD","phone":"05326368554","email":"falibaz@gmail.com"}],"primaryOutcomes":["Proportion of Patients Maintaining Remission After Biologic Treatment Withdrawal"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: testing Tociliuzumab for Takayasu Arteritis","inPlainEnglish":"Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches. Biologic therapies such as tumor necrosis factor inhibitors and tocilizumab are commonly used in patients with refractory or relapsing disease.","whoItsFor":["Ages 18 Years to any","Diagnosis of Takayasu arteritis according to the 2022 American College of Rheumatology/EULAR classification criteria","Treatment with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years","Sustained clinical, laboratory, and radiologic remission","No change in treatment during the previous 12 months","No glucocorticoid use within the previous 6 months"],"whoShouldSkip":["Presence of other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)","Inability to attend scheduled follow-up visits after treatment tapering and discontinuation","Pregnancy or planning pregnancy during the study period"],"whatHappens":"If you join, the listed intervention(s) are Tociliuzumab, Infliximab, or Adalimumab. The registry lists allocation as na. Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Istanbul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.274Z"},{"nctId":"NCT07492641","title":"BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease","officialTitle":"An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BeOne Medicines","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to investigate the efficacy and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.","conditions":["HR+/HER2- Breast Cancer"],"keywords":["CDK4 inhibitor","CDK4/6 inhibitor"],"interventions":[{"type":"DRUG","name":"BGB-43395"},{"type":"DRUG","name":"Letrozole"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Palbociclib"},{"type":"DRUG","name":"Ribociclib"}],"enrollment":1056,"startDate":"2026-05-22","completionDate":"2029-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent.\n* Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.\n* Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Participants who have received prior systemic treatment in the advanced or metastatic setting.\n* Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.\n* Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Alabama Oncology Princeton","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alaska Oncology and Hematology, Llc","city":"Anchorage","state":"Alaska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fairbanks Cancer Care Physicians Pc","city":"Fairbanks","state":"Alaska","country":"United 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The registry lists allocation as randomized. This study wants to investigate the how well it works and safety of BGB-43395 in combination with letrozole compared with investigator's choice of cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) in combination with letrozole in patients with advanced or metastatic hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (BC) who have not received prior systemic treatment for advanced or metastatic disease.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,056 people at 241 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.719Z"},{"nctId":"NCT07492680","title":"A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)","officialTitle":"A Phase 2 Open-Label, Multi-Center Study of Navlimetostat (BMS-986504) as Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTap-5)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which Navlimetostat (BMS-986504) is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of Navlimetostat (BMS-986504) alone and in combination regimens.","conditions":["Solid Tumors"],"keywords":["MTAP","CDKN2A","PRMT5","MountainTAP","Targeted therapy","Brain cancer","GBM","Melanoma","NSCLC","Lung cancer","Pancreatic cancer, Pancreatic Ductal Adenocarcinoma (PDAC)","Navlimetostat","Navli"],"interventions":[{"type":"DRUG","name":"Navlimetostat"},{"type":"DRUG","name":"Daraxonrasib"},{"type":"DRUG","name":"Temozolomide"},{"type":"DRUG","name":"Pumitamig"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Nab-paclitaxel"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Cisplatin"}],"enrollment":254,"startDate":"2026-07-27","completionDate":"2028-08-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss detected in tumor tissue.\n* Depending on the cohort enrolled, participants must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment (there must be no available treatment with curative intent or participant is ineligible or declines treatment) or be treatment-naïve with no prior systemic anticancer therapy for their unresectable or metastatic disease.\n* Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline.\n* Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer.\n* Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor.\n* Participants must not have active brain metastases or carcinomatous meningitis. Participants are eligible if brain metastases are adequately treated, and participants are neurologically stable for at least 2 weeks prior to enrollment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent).\n* Participants must not have history of gastrointestinal disease or other gastrointestinal conditions within 6 months prior to enrollment (including uncontrolled nausea, vomiting, malabsorption syndrome or non-gastrointestinal fistula, gastrointestinal perforation, or intra-abdominal abscess) likely to alter absorption of study treatment or result in inability to swallow oral medications.\n* Participants must not have inadequate organ function, as determined by laboratory testing within the screening period.\n* Participants must not have active viral HBV or HCV hepatitis.\n* Other protocol defined inclusion/exclusion criteria applies.","locations":[{"facility":"Local Institution - 0096","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0182","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emory University - Winship Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0124","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0119","city":"Ann Arbor","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0129","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0174","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0181","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0142","city":"Buffalo","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Laura and Isaac Perlmutter Cancer Center at NYU Langone","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0100","city":"Durham","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0086","city":"Seattle","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0134","city":"Madison","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel","city":"Brussels","state":"Bruxelles-Capitale, Région de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cliniques universitaires Saint-Luc","city":"Brussels","state":"Bruxelles-Capitale, Région de","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent","city":"Ghent","state":"Oost-Vlaanderen","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0051","city":"Vancouver","state":"British Columbia","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0021","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0007","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0155","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Cancer Hospital","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0184","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan Medical University","city":"Xinxiang","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai GoBroad Cancer Hospital China Pharmaceutical University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Georges François Leclerc","city":"Dijon","state":"Côte-d'Or","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0075","city":"Pierre-Bénite","state":"Rhône","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0116","city":"Villejuif","state":"Val-de-Marne","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Saint-Louis","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Hamburg","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0039","city":"Heidelberg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Leipzig","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz","city":"Mainz","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Rechts der Isar der Technischen Universitaet Muenchen","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Wuerzburg","city":"Würzburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0150","city":"Hksar","state":"","country":"Hong Kong","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0063","city":"Shatin","state":"","country":"Hong Kong","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cork University Hospital","city":"Cork","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Misericordiae University Hospital (MMUH)","city":"Dublin","state":"","country":"Ireland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0146","city":"Dublin","state":"","country":"Ireland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Senese","city":"Siena","state":"Tuscany","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII","city":"Bergamo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione IRCCS Istituto Nazionale dei Tumori","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Nazionale Tumori IRCCS Fondazione Pascale","city":"Naples","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Santa Maria della Misericordia in Perugia","city":"Perugia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haukeland Universitetssjukehus","city":"Bergen","state":"Hordaland","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oslo Universitetssykehus HF, Ullevål","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"Seoul-teukbyeolsi [Seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"Barcelona [Barcelona]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0071","city":"Hospitalet","state":"Barcelona [Barcelona]","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Marañon","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Part 1: Number of participants who achieve Objective Response (OR)","Part 2: Number of participants with adverse events meeting protocol defined dose limiting toxicities (DLTs) criteria","Part 2: Number of participants with adverse events (AE)","Part 2: Number of participants with Serious AEs (SAEs)","Part 2: Number of participants with treatment related AEs","Part 2: Number of participants with treatment related SAEs","Part 2: Number of participants with AEs leading to study treatment discontinuation","Part 2: Number of participants with AEs leading to death","Part 2: Number of participants with laboratory abnormalities"],"hasResults":false,"conditionSlugs":["lung-cancer","pancreatic-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["san-francisco-california","aurora-colorado","atlanta-georgia","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","rochester-minnesota","buffalo-new-york","new-york-new-york","durham-north-carolina","houston-texas","seattle-washington","madison-wisconsin","brussels-belgium","ghent-belgium","vancouver-canada","toronto-canada","beijing-china","chongqing-china","guangzhou-china","xinxiang-china","shanghai-china","dijon-france","pierre-b-nite-france","villejuif-france","paris-france","hamburg-germany","heidelberg-germany","leipzig-germany","mainz-germany","m-nchen-germany","w-rzburg-germany","hksar-hong-kong","shatin-hong-kong","cork-ireland","dublin-ireland","siena-italy","bergamo-italy","milan-italy","naples-italy","perugia-italy","chuo-ku-japan","bergen-norway","oslo-norway","seoul-south-korea","barcelona-spain","hospitalet-spain","madrid-spain","seville-spain"],"enrichment":{"headline":"Phase 2: testing Navlimetostat for Solid Tumors","inPlainEnglish":"This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a this drug alone component and a combination component in which Navlimetostat (BMS-986504) is given with other anti-cancer agents.","whoItsFor":["Ages 18 Years to any","Participant must have histologically confirmed diagnosis of advanced and/or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene or MTAP loss detected in tumor tissue","Participant must have presence of at least one measurable tumor lesion per RECIST v1.1 or mRECIST at baseline and Radiologic assessment in neuro-oncology (RANO)2.0 as applicable at baseline","Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time (APTT) must be ≤ 1.5 × ULN; or ≤ 2 x ULN in subjects with liver metastasis or liver cancer","Participant must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1"],"whoShouldSkip":["Participants must not have prior treatment with a PRMT5 or Methionine adenosyl transferase 2A (MAT2A) inhibitor","Participants must not have inadequate organ function, as determined by laboratory testing within the screening period","Participants must not have active viral HBV or HCV hepatitis","Other protocol defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Navlimetostat, Daraxonrasib, or Temozolomide. The registry lists allocation as na. This is an open-label, multicenter Phase 2 study evaluating Navlimetostat (BMS-986504) in participants with advanced and/or metastatic solid tumors that have MTAP deletion.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 254 people at 58 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.806Z"},{"nctId":"NCT07497399","title":"Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis","officialTitle":"Targeting Agonists of Glucagon-like Peptide-1 Receptor for Multiple Sclerosis (TAG-MS): A Phase 2, Randomized, Double-Blind, Parallel-Arm Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).\n\nResearchers will compare outcomes from participants randomized to the study drug, versus participants randomized to placebo, to see if there are signs of slowed neurodegeneration (i.e., reduction in brain and retinal atrophy).","conditions":["Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"NLY01"},{"type":"DRUG","name":"Placebo"}],"enrollment":120,"startDate":"2026-04-28","completionDate":"2030-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI\n* Aged 18-60 years\n* Body mass index ≥27.0 kg/m2\n\nExclusion Criteria:\n\n* No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication class\n* No known Barrett's esophagus/gastroesophageal reflux disease, pancreatitis (including past), or gastroparesis\n* No personal/family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2\n* No chronic kidney disease (estimated glomerular filtration rate ≤50 mL/min) in past year, type 1 diabetes, known diabetic retinopathy, use of insulin or insulin-inducing medications\\*, dipeptidyl peptidase IV inhibitors\\*\\*, or warfarin; current/active alcohol or illicit substance abuse\n* No concerns about candidacy of individual on part of person's neurologist or study team clinicians\n* Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\\*\\*\\*\n\n  * currently-approved: Lispro, Aspart, Glulisine, Afrezza, Regular, Concentrated Regular, or Novolin, Velosulin, NPH, glargine, detemir, degludec, and premixed; approved secretagogues: sulphonylureas (e.g. glipizide (± metformin), glyburide (± metformin), glimepiride, pioglitazone/glimepiride) \\& meglitinide analogues (nateglinide and repaglinide); \\*\\* currently-approved:sitagliptin, saxagliptin, linagliptin, alogliptin \\*\\*\\*Contraception: Participants of childbearing potential (participant has a uterus and is pre-menopausal) must agree to use contraception, using either one method with a failure rate of \\<1%/year, or two methods of lesser effectiveness:\n\nContraceptive methods with a failure rate of \\< 1% per year includes the following:\n\n* Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD\n* Complete abstinence from sexual encounters with a person who has testes\n\nThose who do not wish to use one of the above methods of contraception must use two methods. Options include:\n\n* Oral hormonal contraception plus one barrier method during sexual encounter with a person who has testes (below). While typically oral hormonal contraception has a low failure rate, it is possible that the absorption of contraceptive pills taken by mouth will be impacted by the study drug and thus lower contraceptive effectiveness. Thus, people using pills as primary contraception must, during asexual encounter with a person who has testes, use a second form of barrier contraceptive (below) or must change to one of the other contraceptive methods listed above.\n* Two forms of barrier contraception during sexual encounter with a person who has testes. Examples of barrier contraceptive methods include the following:\n\n  * A condom with or without spermicide\n  * A cap, diaphragm, or sponge with or without spermicide\n\n    * Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.","locations":[{"facility":"University of Kansas Medical Center","city":"Kansas City","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mount Sinai School of Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Manager","phone":"667-306-8153","email":"mvieira4@jh.edu"}],"primaryOutcomes":["Change in normalized (for head size) brain parenchymal volume (nBPV)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["kansas-city-kansas","baltimore-maryland","new-york-new-york"],"enrichment":{"headline":"Phase 2: testing NLY01 for Multiple Sclerosis","inPlainEnglish":"The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis. The main outcome for the trial is change in normalized brain parenchymal volume (nBPV), measured by magnetic resonance imaging (MRI).","whoItsFor":["Ages 18 Years to 60 Years","Diagnosis of MS (2024 criteria); clinically stable on MS therapy for ≥12 months without relapse or new lesions on brain MRI","Body mass index ≥27.0 kg/m2"],"whoShouldSkip":["No GLP-1RA or GIP/GLP-1 RA in past year; no known hypersensitivity to medication class","No known Barrett's esophagus/gastroesophageal reflux disease, pancreatitis (including past), or gastroparesis","No personal/family history of medullary thyroid carcinoma or history of multiple endocrine neoplasia syndrome type 2","No concerns about candidacy of individual on part of person's neurologist or study team clinicians","Current or planned (next 2 years) pregnancy/breastfeeding; if able to become pregnant, agree to reliable contraception (contraception requirements as discussed below)\\*\\*\\*","Contraceptive methods with a failure rate of \\< 1% per year includes the following:","Combined (estrogen and progesterone containing) hormonal contraception (vaginal ring, birth control patch) or progesterone-only hormonal contraception (birth control injections, intrauterine device (IUD), or hormone-releasing implant), or copper IUD"],"whatHappens":"If you join, the listed intervention(s) are NLY01, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to evaluate if the study drug will reduce brain and retinal atrophy by reducing inflammation and subsequently slowing neurodegeneration in people with Multiple Sclerosis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.969Z"},{"nctId":"NCT07497594","title":"ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention","officialTitle":"Expanding PrEP Options Among Young MSM, Transgender and Non-binary Persons in Brazil: Incorporating Twice-yearly Lenacapavir for HIV Prevention - The ImPrEP LEN Brasil Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Oswaldo Cruz Foundation","sponsorClass":"OTHER","summary":"The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP). The main questions it aims to answer are:\n\nHow many participants get HIV while using long-acting lenacapavir? How safe is long-acting lenacapavir in real-world health services? How many participants continue using their chosen prevention method over time? What factors help or make it harder for participants to stay on prevention? Researchers will compare two HIV prevention options to understand how they work in routine care: Long-acting lenacapavir, given as an injection under the skin every 6 months, Daily oral pre-exposure prophylaxis (PrEP), taken as a pill containing tenofovir disoproxil fumarate and emtricitabine, Participants will choose the prevention option they prefer after receiving counseling. This is not a randomized study. Researchers will follow participants for up to 2 years. Participants will: Receive either an injection every 6 months or take a daily pill, Visit the clinic regularly for HIV testing and health checkups, Receive testing and treatment for sexually transmitted infections, Answer questions about their health, medication use, and experiences, Receive prevention counseling and condoms. This study will help health services understand how to offer long-acting HIV prevention in Brazil and how to better support people who want to prevent HIV infection.","conditions":["Contact With or Exposure to Human Immunodeficiency Virus"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lenacapavir long-acting"},{"type":"DRUG","name":"Tenofovi-Emtricitabine (TDF/FTC) tablet"}],"enrollment":1500,"startDate":"2026-02-03","completionDate":"2029-02","sex":"ALL","minAge":"16 Years","maxAge":"30 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAbility to understand and sign the Informed Consent Form, which must be obtained before the initiation of any study procedures, and willingness to comply with the protocol requirements\n\nBe a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man\n\nReport having engaged in anal sex with a person designated male at birth within the last six months\n\nBe between 16 and 30 years of age\n\nHave a body weight equal to or greater than 35 kilograms\n\nSeek care at a participating study clinic for human immunodeficiency virus testing or initiation of human immunodeficiency virus pre-exposure prophylaxis, either spontaneously or through peer invitation\n\nHave a non-reactive result on a rapid test for human immunodeficiency virus\n\nBe an individual without prior use of human immunodeficiency virus pre-exposure prophylaxis, or an individual with prior use who remains in a situation of vulnerability, characterized by:\n\na history of oral human immunodeficiency virus pre-exposure prophylaxis with at least two prior dispensations without return for a new pickup in the six months preceding the enrollment visit, or\n\na history of long-acting cabotegravir use with a delay of at least one scheduled reload dose\n\nExclusion Criteria:\n\nKnown hypersensitivity to the study medication, its metabolites, or formulation excipients\n\nSevere hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascites, encephalopathy, or variceal bleeding\n\nKnown or suspected severe active infection, such as active tuberculosis\n\nNeed for continuous use of contraindicated concomitant medications\n\nAny clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements\n\nConfirmed or suspected infection with the human immunodeficiency virus\n\nPlans to move outside the study area during the follow-up period\n\nPrior participation in a clinical study using Lenacapavir in the PURPOSE study\n\nPrior participation in a human immunodeficiency virus vaccine study, except in cases where the participant provides documentation demonstrating receipt of placebo and not the active product\n\nCurrent participation in another interventional human immunodeficiency virus prevention study that, in the opinion of the investigator, may interfere with the conduct of this study","locations":[{"facility":"Fundação de Medicina Tropical Heitor Vieira Dourado","city":"Manaus","state":"Amazonas","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEDAP - Centro Especializado em Diagnóstico, Assistência e Pesquisa","city":"Salvador","state":"Estado de Bahia","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Geral de Nova Iguaçu","city":"Nova Iguaçu","state":"Rio de Janeiro","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Infectologia Evandro Chagas","city":"Rio de Janeiro","state":"Rio de Janeiro","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTA/Policlínica Centro","city":"Florianópolis","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Referência em IST/Aids de Campinas (SMS/PMC)","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Coordenadoria de IST/Aids da Cidade de São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Referência e Treinamento em DST/Aids de São Paulo","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Beatriz Grinsztejn, PhD","phone":"+55 2138659128","email":"gbeatriz@ini.fiocruz.br"},{"name":"Valdiléa Veloso, PhD","phone":"","email":"valdilea.veloso@ini.fiocruz.br"}],"primaryOutcomes":["Proportion of participants who remain persistent on Lenacapavir pre-exposure prophylaxis at 24 months","Time to discontinuation of Lenacapavir pre-exposure prophylaxis"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["manaus-brazil","salvador-brazil","nova-igua-u-brazil","rio-de-janeiro-brazil","florian-polis-brazil","campinas-brazil","s-o-paulo-brazil"],"enrichment":{"headline":"Not a traditional drug phase: testing Lenacapavir long-acting for Contact With or Exposure to Human Immunodeficiency Virus","inPlainEnglish":"The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil. The study will also learn about safety, continued use over time, and whether people prefer this option compared to daily oral pre- exposure prophylaxis (PrEP).","whoItsFor":["Ages 16 Years to 30 Years","Be a cisgender man, a non-binary person designated male at birth, or a transgender woman or transgender man","Report having engaged in anal sex with a person designated male at birth within the last six months","Be between 16 and 30 years of age","Have a body weight equal to or greater than 35 kilograms","Seek care at a participating study clinic for human immunodeficiency virus testing or initiation of human immunodeficiency virus pre-exposure prophylaxis, either spontaneously or through peer invitation","Have a non-reactive result on a rapid test for human immunodeficiency virus","Be an individual without prior use of human immunodeficiency virus pre-exposure prophylaxis, or an individual with prior use who remains in a situation of vulnerability, characterized by:"],"whoShouldSkip":["Known hypersensitivity to the study medication, its metabolites, or formulation excipients","Severe hepatic impairment or a history or current clinical condition of decompensated liver cirrhosis, such as ascites, encephalopathy, or variceal bleeding","Known or suspected severe active infection, such as active tuberculosis","Need for continuous use of contraindicated concomitant medications","Any clinical or psychosocial condition, or prior treatment, that in the opinion of the investigator makes the participant unsuitable for the study or unable to comply with dosing requirements","Confirmed or suspected infection with the human immunodeficiency virus","Plans to move outside the study area during the follow-up period"],"whatHappens":"If you join, the listed intervention(s) are Lenacapavir long-acting, or Tenofovi-Emtricitabine (TDF/FTC) tablet. The registry lists allocation as randomized. The goal of this study is to learn how well long-acting lenacapavir works to prevent human immunodeficiency virus (HIV) infection in people at higher risk of getting HIV in Brazil.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,500 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.401Z"},{"nctId":"NCT07498283","title":"Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation","officialTitle":"Explore and Improve Mental Well-being Among Vulnerable Patients With Atrial Fibrillation - A Randomized Controlled Trial of a Peer-Mentor Intervention","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University College Copenhagen","sponsorClass":"OTHER","summary":"The goal of this randomized clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life. These challenges are particularly pronounced among individuals with low socioeconomic position, who may face additional barriers to accessing supportive care.\n\nThe main question the study aims to answer is:\n\nDoes a 16-week peer-mentor intervention reduce anxiety symptoms among patients with AF compared with usual care?\n\nResearchers will compare peer-mentor support plus usual care with usual care alone.\n\nParticipants will:\n\nComplete questionnaires about anxiety, depressive symptoms, quality of life, and self-efficacy at baseline and after 16 weeks.\n\nBe randomized either to receive peer-mentor support for 16 weeks or to receive usual care only.\n\nIf allocated to the intervention group, be matched with a trained peer mentor with lived experience of atrial fibrillation who provides emotional support and practical guidance through approximately eight contacts over the 16-week period.\n\nThe study will also include follow-up using national health registers and a mixed-methods process evaluation exploring participants' and mentors' experiences with the intervention.","conditions":["Atrial Fibrillation"],"keywords":["Peer mentor support","Mental well-being","Anxiety","Self-efficacy","Socioeconomic vulnerability","Atrial fibrillation","Cardiac patients"],"interventions":[{"type":"BEHAVIORAL","name":"Peer-Mentor Support"}],"enrollment":290,"startDate":"2026-05-26","completionDate":"2027-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (≥18 years) with a confirmed diagnosis of atrial fibrillation\n* Low socioeconomic position, primarily defined as educational attainment of vocational education or below\n* Able to understand and speak Danish\n* Able to provide written informed consent\n* Able to complete study questionnaires\n\nExclusion Criteria:\n\n* Inability to provide informed consent","locations":[{"facility":"Herlev and Gentofte Hospital","city":"Herlev","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nordsjealland Hospital","city":"Hillerød","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amager and Hvidovre Hospital","city":"Hvidovre","state":"Capital Region","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cecilie M L Mielow, MScN","phone":"+4523474229","email":"cecilie.mia.lykke.mielow.01@regionh.dk"}],"primaryOutcomes":["Anxiety symptoms measured by the Hospital Anxiety and Depression Scale (HADS-A)"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["herlev-denmark","hiller-d-denmark","hvidovre-denmark"],"enrichment":{"headline":"Not a traditional drug phase: Peer-Mentor Support for Atrial Fibrillation","inPlainEnglish":"The goal of this randomly assigned clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF). Patients with AF often experience anxiety, uncertainty, and reduced quality of life.","whoItsFor":["Ages 18 Years to any","Adults (≥18 years) with a confirmed diagnosis of atrial fibrillation","Low socioeconomic position, primarily defined as educational attainment of vocational education or below","Able to complete study questionnaires"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Peer-Mentor Support. The registry lists allocation as randomized. The goal of this randomly assigned clinical trial is to evaluate whether a peer-mentor intervention can improve mental well-being among vulnerable patients with atrial fibrillation (AF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 290 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.739Z"},{"nctId":"NCT07498335","title":"Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN","officialTitle":"A Single-arm, Multicenter, Phase III Study to Assess Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients of 2 to <18 Years of Age With Primary Immunoglobulin A Nephropathy (IgAN)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \\<18 years with primary immunoglobulin A nephropathy (IgAN).","conditions":["Berger Disease","Bergers Disease","IgA Nephropathy","Immunoglobulin A Nephropathy","Primary IgAN","Nephritis IgA Type, Nephropathy IgA Type"],"keywords":["Kidney Diseases","Kidney Disease, Chronic","Glomerulonephritis","Urologic Diseases","Glomerular Disease","Glomerulonephritis, IGA","Glomerulopathy","Immunoglobulin Disease","Atrasentan"],"interventions":[{"type":"DRUG","name":"Drug: Atrasentan"}],"enrollment":28,"startDate":"2026-08-06","completionDate":"2031-09-15","sex":"ALL","minAge":"2 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Signed informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed. A consent or assent may also be required for some participants depending upon their age and local requirement.\n2. Male and female participants 2 to \\< 18 years of age as of Day 1.\n3. eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period.\n4. Kidney biopsy-proven primary IgAN\\*, with biopsy performed within 3 years of Screening with \\< 50% tubulointerstitial fibrosis and \\< 25% crescents. In case a kidney biopsy within 3 years from Screening is not available, a kidney biopsy may be performed if it is part of the planned diagnostic approach and clinical management of the participant.\n5. Proteinuria due to primary diagnosis of IgAN as assessed by UPCR ≥ 1 g/g (113 mg/mmoL) sampled from FMV at Screening on Day -90 and Day -60 as well as during the Run-in Period despite treatment with maximum tolerated dose of ACE inhibitor/ARB for at least 120 days prior to Day 1. Note: UPCR will be assessed based on one FMV sample at Day -90 and based on the geometric mean of 2 FMV samples for the Day -60 visit and during the Run-in Period.\n6. All participants must have been on supportive care including stable dose regimen of ACE inhibitor or ARB at either the locally approved maximal daily dose per body weight, or the maximally tolerated dose (per Investigator's judgment for pediatric use), for at least 120 days before first study drug administration. In addition, if participants are taking diuretics, other antihypertensive medication, or other background medication for IgAN (such as SGLT2 inhibitors), the doses should also be stabilized for at least 120 days prior to the first dosing of study treatment. Note: Participants with allergies or intolerance to ACE inhibitors and ARBs are eligible for the study. Participants with allergies or intolerance to RAS inhibitors are eligible but will not exceed \\~5% of the total population treated (maximum of 2 participants).\n7. The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1.\n8. Parent(s)/guardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child.\n\nExclusion Criteria:\n\n1. Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations.\n2. History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.\n3. Any secondary IgAN as defined by the investigator; secondary IgAN can be associated with cirrhosis, celiac disease, Human Immunodeficiency Virus (HIV) infection, Herpes Simplex virus infection, dermatitis herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, and familial mediterranean fever before treatment.\n4. A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain.\n5. Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1.\n6. Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration.\n7. Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening.\n8. Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods.\n9. Presence of nephrotic syndrome at Screening based on the investigator's judgement.\n10. BNP value of \\>200 pg/mL at Screening.\n11. Hemoglobin below 9 g/dL at Screening or prior history of blood transfusion for anemia within 3 months of Screening.\n12. Platelet count \\<80,000/μL at Screening.\n13. On Day 1 participants' body weight falls below the lower limit of the cohort in which the participant was initially screened and lower body weight cohort is not open for enrollment.\n14. Known history of congenital heart disease, heart failure or clinically significant fluid retention such as pulmonary edema, uncontrolled peripheral edema, pleural effusion, or ascites before treatment.\n15. Current use of any homeopathic and/or herbal medications for the treatment of IgAN disease , such as but not limited to Tripterygium wilfordii (Lei Gong Teng), Caulis sinomenii and Sinomenium acutum before treatment.\n16. History of an alcohol or illicit drug-related disorder within the past 3 years at Screening.\n17. Confirmed blood pressure \\>150 mmHg systolic or \\>95 mmHg diastolic for 12 to \\<18 years of age; \\>140 mmHg systolic or \\>90 mmHg diastolic for 6 to \\<12 years of age; \\>120 mmHg systolic or \\>80 mmHg diastolic for 2 to \\<6 years of age; based on the mean of 3 measurements obtained at Screening; or clinically significant hypotension at screening.\n18. Participants previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), calcineurin inhibitors, complement inhibitors, oral budesonide in any dose, systemic corticosteroid exposure ≥0.5 mg/kg/day or \\> 7.5 mg total exposure in a single day of prednisone/prednisolone equivalent within 120 days (or 180 days for rituximab) prior to first study drug administration.\n\n    Participants treated with endothelin (receptor) antagonists (including sparsentan) within 120 days prior to first study drug administration.\n19. History of organ transplantation (subjects with history of corneal transplant are not excluded) before treatment.\n20. Major concurrent comorbidities before treatment including but not limited to advanced cardiac disease (e.g., NYHA class III (for ages 6 to \\<18 years), Ross class III (for ages 2 to \\<6years)), severe pulmonary disease (e.g., WHO class III (for age 17 years); Pulmonary Vascular Research Institute (PVRI) class III (for 2-\\<17 years)), or hepatic disease (e.g., active hepatitis) that in the opinion of the investigator precludes subject's participation in the study.\n21. Any medical condition deemed likely to interfere with the subject's participation in the study before treatment.\n22. Active systemic bacterial, viral (including COVID-19) or fungal infection within 14 days prior to study drug administration.\n23. Presence of fever ≥ 38°C (100.4°F) within 7 days prior to study drug administration.\n24. Human immunodeficiency virus (HIV) infection (known history of HIV or test positive for HIV antibody at Screening).\n25. Liver disease, such as active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection defined as Hepatitis B surface antigen (HBsAg) positive or Hepatitis C virus ribonucleic acid (HCV-RNA) positive at Screening, or liver injury as indicated by abnormal liver function tests at Screening and Baseline as defined below:\n\n    * Any single parameter of ALT, AST, GGT, alkaline phosphatase must not exceed 3X upper limit of normal (ULN)\n    * Serum bilirubin must not exceed 2X ULN\n26. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer treated with curative intent), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases; for children aged 2 to \\<5 years of age, history of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, inclusive of malignancies diagnosed at birth and during the neonatal and childhood time, regardless of whether there is evidence of local recurrence or metastases.\n27. Pregnant or nursing (lactating) female participants (of childbearing potential), where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test at Screening.\n28. Subjects taking prohibited therapies before treatment.\n29. Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \\< 1% per year) while taking study treatment and for 1 month after stopping study treatment.\n\nHighly effective contraception methods include:\n\n* Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.\n* Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.\n* Bilateral tubal occlusion, Bilateral tubal ligation (at least six weeks before taking study treatment).\n* Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to screening provided partner(s) has(have) received medical confirmation of surgical success.\n* Use of hormonal contraception methods:\n* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.\n* Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.\n* Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment. If local regulations are more stringent than the contraception methods listed above, local regulations apply and will be described in the ICF. 30. For fertile male participants, participants must not intend to father a child or donate sperm while taking study treatment and at least 1 month afterward for males.\n* All fertile male participants in a sexual relationship with a WOCBP must agree to the use of a condom during the trial and for up to one month after last study drug administration. A male participant is considered fertile after puberty unless permanently sterile by bilateral orchidectomy/orchiectomy.","locations":[{"facility":"Hackensack Meridian Health","city":"Neptune City","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Childrens Hospital MC","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Science Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Health Science Center- Le Bonheur Research Center","city":"Memphis","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barranquilla","state":"Atlántico","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nantes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kanazawa","state":"Ishikawa-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Chiba","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Seoul","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Cadiz","state":"Andalusia","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Change From Baseline in Proteinuria at Week 36"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["neptune-city-new-jersey","cincinnati-ohio","oklahoma-city-oklahoma","memphis-tennessee","beijing-china","xian-china","medell-n-colombia","barranquilla-colombia","bron-france","nantes-france","paris-france","toulouse-france","nagoya-japan","kanazawa-japan","chiba-japan","fukuoka-japan","seoul-south-korea","cadiz-spain","barcelona-spain","madrid-spain","taipei-taiwan","taoyuan-taiwan"],"enrichment":{"headline":"Phase 3: testing Drug: Atrasentan for Berger Disease","inPlainEnglish":"A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \\<18 years with primary immunoglobulin A nephropathy (IgAN).","whoItsFor":["Ages 2 Years to 18 Years","Male and female participants 2 to \\< 18 years of age as of Day 1","eGFR ≥ 30 mL/min/1.73m2 where eGFR is calculated using the modified Schwartz formula at Screening and confirmed during the Run-in Period","The minimum body weight of enrolled pediatric participants is 10 kg at Screening and confirmed on Day 1","Parent(s)/guardian(s) are to be able to communicate well with the investigator and to understand and comply with the study's requirements for their child"],"whoShouldSkip":["Participation in any other investigational drug trial or use of other investigational drugs at the time of enrollment, or within 5 elimination half-lives of enrollment, or within 30 days of enrollment, whichever is longer; or longer if required by local regulations","History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes","A clinical diagnosis of IgA vasculitis (IgAV or Henoch-Schoenlein purpura) based on typical palpable purpura with or without arthralgia and abdominal pain","Evidence of significant urinary obstruction or difficulty in voiding, any urinary tract disorder causing significant urinary obstruction or difficulty in voiding at Screening and confirmed at Baseline/Day 1","Concurrent diagnosis of CKD other than IgAN at Screening and before first study drug administration","Current acute kidney injury (AKI) defined by Acute Kidney Injury Network (AKIN) criteria within 4 weeks of Screening","Presence of rapidly progressive glomerulonephritis (RPGN) as defined by 50% decline in eGFR within 3 months prior to Screening or during Screening and Run-in periods"],"whatHappens":"If you join, the listed intervention(s) are Drug: Atrasentan. The registry lists allocation as randomized. A Phase III, single-arm, multicenter pediatric clinical study evaluating atrasentan in children and adolescents aged 2 to \\<18 years with primary immunoglobulin A nephropathy (IgAN).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 28 people at 22 sites. 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London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"London North West University Healthcare NHS Trust","city":"Greater London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Middlesex University Hospital","city":"Iselworth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals Nhs Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Free Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chelsea And Westminster Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imperial College London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norfolk and Norwich University Hospital","city":"Norwich","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Cross Hospital","city":"Wolverhampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Participants with Deep Remission at Week 52"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["risankizumab"],"locationSlugs":["dothan-alabama","mobile-alabama","anaheim-california","lancaster-california","los-alamitos-california","los-angeles-california","san-diego-california","colorado-springs-colorado","hamden-connecticut","jacksonville-florida","miami-florida","naples-florida","orlando-florida","tampa-florida","atlanta-georgia","macon-georgia","northbrook-illinois","clive-iowa","topeka-kansas","lafayette-louisiana","shreveport-louisiana","glen-burnie-maryland","new-bedford-massachusetts","farmington-hills-michigan","carmel-new-york","new-york-new-york","chapel-hill-north-carolina","charlotte-north-carolina","mentor-ohio","oklahoma-city-oklahoma","uniontown-pennsylvania","summerville-south-carolina","carrollton-texas","lubbock-texas","san-antonio-texas","tyler-texas","graz-austria","innsbruck-austria","linz-austria","salzburg-austria","vienna-austria","wels-austria","wiener-neustadt-austria","brussels-belgium","genk-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","roeselare-belgium","edmonton-canada","vancouver-canada","hamilton-canada","london-canada","oshawa-canada","toronto-canada","montreal-canada","changzhou-china","chongqing-china","fuzhou-china","guangzhou-china","nanjing-china","wuhan-china","brno-czechia","hradec-kralova-czechia","hradec-kr-lov-czechia","ostrava-poruba-czechia","prague-czechia","aarhus-c-denmark","esbjerg-denmark","gistrup-denmark","herlev-denmark","hilleroed-denmark","hvidovre-denmark","k-benhavn-nv-denmark","odense-c-denmark","amiens-france","clermont-ferrand-france","chirolles-france","marseille-france","nantes-france","neuilly-sur-seine-france","n-mes-france","paris-france","pierre-b-nite-france","reims-france","vand-uvre-l-s-nancy-france","berlin-germany","erlangen-germany","grevenbroich-germany","jena-germany","kiel-germany","ludwigshafen-am-rhein-germany","mannheim-germany","m-nchen-germany","budapest-hungary","gy-ngy-s-hungary","szeged-hungary","bologna-italy","bolzano-italy","genova-italy","milan-italy","roma-italy","rozzano-italy","torino-italy","maastricht-netherlands","nijmegen-netherlands","tilburg-netherlands","bydgoszcz-poland","krakow-poland","rzesz-w-poland","szczecin-poland","torun-poland","warsaw-poland","bansk-bystrica-slovakia","bratislava-slovakia","ko-ice-slovakia","nov-z-mky-slovakia","pre-ov-slovakia","rimavsk-sobota-slovakia","alicante-spain","barcelona-spain","ferrol-spain","gij-n-spain","girona-spain","madrid-spain","navarra-spain","santiago-de-compostela-spain","seville-spain","link-ping-sweden","m-lndal-sweden","stockholm-sweden","uppsala-sweden","greater-london-united-kingdom","iselworth-united-kingdom","london-united-kingdom","norwich-united-kingdom","wolverhampton-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Guselkumab for Crohn Disease","inPlainEnglish":"This study wants to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).","whoItsFor":["Ages 18 Years to any","Has CD or fistulizing Crohn's Disease (CD) of at least 12 weeks' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy","Have moderately to severely active CD, defined as baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 but less than or equal to (\\<=) 450","a minimum score of 1 for the component of \"size of ulcers\" AND","a minimum score of 1 for the component of \"ulcerated surface\"","In the opinion of the investigator, participant's disease is appropriate to treat with the maintenance dosing regimens utilized in the study","Adhere to the requirements for concomitant medications for the treatment of CD as mentioned in the protocol"],"whoShouldSkip":["Currently has or is suspected to have an abscess","Has an active fistula during screening or at Week 0 with an anticipated need for surgery","Has had any kind of bowel resection within 24 weeks, or any other intra-abdominal or other major surgery within 12 weeks, before first dose of study intervention","Currently has a malignancy or has a history of malignancy within 5 years before screening"],"whatHappens":"If you join, the listed intervention(s) are Guselkumab, or Risankizumab. The registry lists allocation as randomized. This study wants to assess how well guselkumab works when compared to risankizumab in participants with moderately to severely active Crohn's Disease (CD; a long-term condition causing severe inflammation of the intestinal tract).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 530 people at 164 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.895Z"},{"nctId":"NCT07500246","title":"Advancing Diagnosis and Treatment of Pediatric Asthma","officialTitle":"Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Luxembourg Institute of Health","sponsorClass":"OTHER_GOV","summary":"Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control. Moreover, there is a growing need for non-invasive biomarkers to support better diagnosis and personalized care. The goal of this clinical trial is to investigate if a new digital inhaler can improve inhalation technique and treatment adherence in children aged 5 to 16 years old, with partly controlled or uncontrolled asthma requiring treatment with inhaled corticosteroids. The main questions it aims to answer are:\n\n* Does the use of a digital inhaler improve adherence to inhaled corticosteroids and asthma control in children?\n* Which biomarkers could support diagnosis and help predict treatment responses in children with asthma?\n* How do environmental factors influence asthma control and treatment outcomes?\n\nResearchers will compare adherence to inhaled corticosteroid therapy between children using a new digital inhaler (Whizz spacer) and those using a standard, non-digital inhaler (AeroChamber Plus® Flow-Vu®) to see if the digital inhaler improves treatment administration and asthma control. They will quantify inflammatory markers in biological samples from asthmatic children and children without respiratory disease, to find biomarkers linked to disease and treatment response.\n\nParticipants will:\n\n* Use the Whizz spacer or the AeroChamber Plus® Flow-Vu® during 12 weeks for corticosteroid inhalation, and complete daily a study diary to follow treatment administration.\n* Complete asthma control and quality of life questionnaires and have an evaluation of asthma control through GINA score at baseline, 6 and 12 weeks.\n* Undergo spirometry tests and FENO measurements at baseline and 12 weeks.\n* Give biological samples at baseline and 12 weeks.\n* Collect children's bedroom dust samples at baseline.\n* Wear a bracelet for 7 days at baseline and 12 weeks to monitor physical activity.","conditions":["Asthma Childhood","Asthma","Inhalation Spacers"],"keywords":["Asthma","Child","Immunophenotyping","Environmental exposure","Inhalation spacers","Allergy and asthma"],"interventions":[{"type":"DEVICE","name":"Whizz spacer system"},{"type":"DEVICE","name":"AeroChamber Plus® Flow-Vu®"}],"enrollment":208,"startDate":"2026-01-02","completionDate":"2027-08","sex":"ALL","minAge":"5 Years","maxAge":"16 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged between 5-16 years, male or female\n* Physician diagnosis of asthma requiring a controller treatment with ICS or ICS/Long-acting beta-agonists (LABA) via MDI\n* Partly controlled or uncontrolled asthma based on GINA criteria and definitions\n* Informed consent signed by legally authorized representatives (LAR) and assent from young patient (only applicable for children ≥ 10 years)\n\nExclusion Criteria:\n\n* Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection\n* Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO/cystic fibrosis etc.)\n* Severe asthma based on GINA definitions\n* Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))\n* Immune deficiency or under immunosuppressive treatments\n* In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)\n* Patients with neurological diseases / impaired cognitive disorder\n* Siblings of patients already included in the study","locations":[{"facility":"CHC Mont Légia","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Luxembourg Research Clinic (LRC)","city":"Luxembourg","state":"","country":"Luxembourg","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christiane Hilger, PhD","phone":"+352 26970258","email":"christiane.hilger@lih.lu"},{"name":"Ali Znati","phone":"+352 26970-811","email":"ALi.Znati@lih.lu"}],"primaryOutcomes":["Measurement of inhaled corticosteroid therapy adherence and comparison between the two spacers"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["li-ge-belgium","luxembourg-luxembourg"],"enrichment":{"headline":"Not a traditional drug phase: Whizz spacer system for Asthma Childhood","inPlainEnglish":"Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control.","whoItsFor":["Ages 5 Years to 16 Years","Patient aged between 5-16 years, male or female","Physician diagnosis of asthma requiring a controller treatment with ICS or ICS/Long-acting beta-agonists (LABA) via MDI","Partly controlled or uncontrolled asthma based on GINA criteria and definitions"],"whoShouldSkip":["Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection","Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO/cystic fibrosis etc.)","Severe asthma based on GINA definitions","Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))","Immune deficiency or under immunosuppressive treatments","In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)","Patients with neurological diseases / impaired cognitive disorder"],"whatHappens":"If you join, the listed intervention(s) are Whizz spacer system, or AeroChamber Plus® Flow-Vu®. The registry lists allocation as randomized. Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 208 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.338Z"},{"nctId":"NCT07501078","title":"Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation","officialTitle":"Aquamin® for Prevention of Ulcerative Colitis J-Pouch-associate Intestinal Inflammation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Muhammad N Aslam, MD","sponsorClass":"OTHER","summary":"Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed. Current treatments are limited, and there are no known ways to prevent pouchitis from starting. This study is being done to find out if a natural mineral supplement called Aquamin® can help reduce inflammation and protect the gut lining in people with a J-pouch, and may reduce the risk of pouchitis. By understanding whether Aquamin® is safe and helpful, the study team hopes to find a new and better way to prevent inflammation and improve the long-term health of people with UC.","conditions":["Ulcerative Colitis","Ileal Pouch"],"keywords":["J-pouch without an ileostomy","Surveys","Sample collection","Placebo","Aquamin®","Randomization"],"interventions":[{"type":"DRUG","name":"Aquamin"}],"enrollment":52,"startDate":"2026-11","completionDate":"2029-08","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be able to give written informed consent (or assent as appropriate)\n* Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last nine months\n* For pre-menopausal women 18 years of age and older with intact reproductive organs, a negative pregnancy test is required within two weeks prior to the baseline visit. Participants in this age group must agree to use an acceptable form of contraception throughout the study per protocol.\n\nExclusion Criteria:\n\n* Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study.\n* Must not be participating in any other interventional trial using an investigational drug.\n* Subjects likely to be uncooperative or unable to comply with study procedures\n* History or diagnosis of Crohn's disease\n* History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors).\n* History or diagnosis of any gastrointestinal malignancy\n* Kidney disease, including kidney \"stones\" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)\n* Congenital coagulopathies or hereditary hemorrhagic disorders; treatment with therapeutic doses of warfarin or heparin\n* Participants will be excluded if they have used any of the following within the past 30 days or are unwilling to withdraw for 30 days prior to entering into the study:\n\n  * Calcium, Magnesium, including multivitamins that have low amounts of Calcium/Magnesium and fiber supplements. (Multivitamins without any minerals are allowed).\n  * Non-steroidal anti-inflammatory medications (NSAIDs), such as Naproxen or Ibuprofen (except for occasional pain control or low dose aspirin for cardiovascular disease prevention) per protocol.\n  * Oral or rectal Corticosteroids (a type of steroid drug such as prednisone or cortisol that helps the body to regulate stress response, immune response and inflammation) and antibiotics (except these can be used briefly during a flare-up once the study treatment has begun after the subject enrolled, if prescribed by the personal physician). Inhaled and skin corticosteroids preparations are ok and not an exclusion criteria.","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lauren Manning","phone":"734-615-7236","email":"lbadish@med.umich.edu"}],"primaryOutcomes":["Changes in Intestinal permeability assessed by urinary Lactulose/mannitol urinary ratio"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Phase 2: testing Aquamin for Ulcerative Colitis","inPlainEnglish":"Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool. Some patients develop a problem called pouchitis, where this pouch becomes inflamed.","whoItsFor":["Ages 18 Years to 80 Years","Must have the following: UC with ileal pouch-anal anastomosis (IPAA) using a J-pouch without an ileostomy within the last nine months"],"whoShouldSkip":["Female subjects must not be pregnant or lactating; and female of childbearing potential unwilling to use acceptable birth control throughout the study","Must not be participating in any other treatment trial using an investigational drug","Subjects likely to be uncooperative or unable to comply with study procedures","History or diagnosis of Crohn's disease","History or diagnosis of hereditary gastrointestinal (GI) syndromes, Severe gastrointestinal bleeding/complications, (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors)","History or diagnosis of any gastrointestinal malignancy","Kidney disease, including kidney \"stones\" or hypercalcemia. acute renal failure (past 12 weeks). (Note: A doubtful stone passed in the urine more than three years ago is not considered evidence of current renal stone disease.)"],"whatHappens":"If you join, the listed intervention(s) are Aquamin. The registry lists allocation as na. Ulcerative colitis (UC) is a disease that causes long-term inflammation in the digestive tract, and many people with this condition require surgery to remove the colon and create a new J-pouch for stool.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 52 people at Ann Arbor. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.215Z"},{"nctId":"NCT07502508","title":"Phase 2 Trial of Icovamenib in Participants With Type 2 Diabetes Mellitus Who Are Not Achieving Glycemic Targets While Using GLP-1-Based Therapy","officialTitle":"Phase 2 Randomized, Double-blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Icovamenib in Participants With Type 2 Diabetes Not Achieving Glycemic Targets Despite GLP-1-Based Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Biomea Fusion Inc.","sponsorClass":"INDUSTRY","summary":"This is a phase 2 randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite GLP-1-based therapy.","conditions":["Type 2 Diabetes"],"keywords":["Type 2 Diabetes"],"interventions":[{"type":"DRUG","name":"icovamenib 100 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":60,"startDate":"2026-04-30","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Males or females, age ≥18 years and ≤75 years\n2. Have been diagnosed with T2D\n3. Taking FDA-approved GLP-1 based therapy (administered as subcutaneous injection) and have been treated with lifestyle management and 0 to 2 additional antihyperglycemic medications (metformin and/or SGLT2 inhibitor) with a stable dose of all medications for at least 3 months prior to screening\n4. Have HbA1c ≥7.0 and ≤10.5%\n5. Have a BMI 25 to 45 kg/m2\n6. Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements.\n7. Willing and able to provide written, signed informed consent and be willing and able to comply with all study procedures and tests.\n\nKey Exclusion Criteria:\n\n1. Have type 1 diabetes mellitus or a secondary form of diabetes\n2. Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening\n3. Have a history of severe hypoglycemia (defined by the occurrence of hypoglycemia symptoms requiring the assistance of another person for recovery) in the 6 months prior to screening or a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms as judged by the investigator\n4. Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma\n5. Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin","locations":[{"facility":"Central Research Associates, LLC dba Flourish Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Clinical Research","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southwest General Healthcare Center","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Panax Clinical Research","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research Orlando","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research, Endocrine Consultants PC","city":"Columbus","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"David Kavtaradze MD, Inc","city":"Cordele","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excel Clinical Research","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research, Lucas Research, Inc.","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diabetes and Endocrinology Associates of Stark County","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elligo Health Research, Inc.","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zenos Clinical Research","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Group Medical","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Clinical Research","city":"Lewisville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Group Medical","city":"Missouri City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diabetes & Glandular Disease Clinic, P.A.","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Burke Internal Medicine and Research","city":"Burke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Biomea Fusion Inc.","phone":"8442450490","email":"clinicaltrials@biomeafusion.com"}],"primaryOutcomes":["To demonstrate that icovamenib 100 mg once daily for 12 weeks is superior to placebo for glycemic control"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","canoga-park-california","long-beach-california","montclair-california","san-diego-california","fort-myers-florida","miami-lakes-florida","winter-park-florida","columbus-georgia","cordele-georgia","las-vegas-nevada","morehead-city-north-carolina","canton-ohio","austin-texas","dallas-texas","houston-texas","lewisville-texas","missouri-city-texas","san-antonio-texas","burke-virginia"],"enrichment":{"headline":"Phase 2: testing icovamenib 100 mg for Type 2 Diabetes","inPlainEnglish":"This is a phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial assessing the how well it works and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite GLP-1-based therapy.","whoItsFor":["Ages 18 Years to 75 Years","Males or females, age ≥18 years and ≤75 years","Have been diagnosed with T2D","Have HbA1c ≥7.0 and ≤10.5%","Have a body-mass index (BMI) 25 to 45 kg/m2","Female participants of childbearing potential must have a negative pregnancy test, must be non-lactating, must be willing to have additional pregnancy tests during the study, must agree to the sex and contraception requirements"],"whoShouldSkip":["Have type 1 diabetes mellitus or a secondary form of diabetes","Have a history of diabetic ketoacidosis or hyperosmolar coma in the 6 months prior to screening","Have personal or family history (first-degree relative) of MEN1 or MEN2 or medullary thyroid carcinoma","Use of any of the following in the 3 months prior to screening: compounded GLP-1-based therapy, sulfonylureas, meglitinides, thiazolidinediones, alpha glucosidase inhibitor, DPP4I, bile acid sequestrants, dopamaine-2 agonists, amylin, or insulin"],"whatHappens":"If you join, the listed intervention(s) are icovamenib 100 mg, or Placebo. The registry lists allocation as randomized. This is a phase 2 randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment trial assessing the how well it works and safety of icovamenib in participants with Type 2 Diabetes (T2D) not achieving glycemic targets despite GLP-1-based therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.732Z"},{"nctId":"NCT07503561","title":"A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection","officialTitle":"A Randomized, Adaptive, Double-Blind, Placebo-Controlled, Operationally Seamless Phase 2/3 Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of AIC263029 in the Treatment of BKV Infection in Kidney Transplant Recipients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"AiCuris Anti-infective Cures AG","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.\n\nResearchers will compare AIC263029 to a placebo (a look-alike injection with no active drug). Participants will be assigned by chance to receive AIC263029 or placebo and will receive weekly injections under the skin for 4 weeks. Participants will have clinic visits and blood tests during treatment and follow-up to monitor safety and measure BKV levels, and will be followed for up to about 24 weeks after treatment.","conditions":["BK Virus Infection","BKV Infection","Kidney Transplant"],"keywords":["BK Virus","BK Viremia in kidney transplant","antisense oligonucleotide","AIC263029","AIC468"],"interventions":[{"type":"DRUG","name":"AIC263029"},{"type":"DRUG","name":"Placebo"}],"enrollment":24,"startDate":"2026-10-05","completionDate":"2027-09-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female aged 18 years or older\n2. Kidney transplantation within 12 months prior to randomization\n3. First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:\n\n   1. positive BKV DNA test of one time \\>104 IU/mL and \\<106 IU/mL, within 30 days prior to randomization, or\n   2. \\>103 IU/mL and ≤104 IU/mL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization.\n4. Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \\<1% per year until the end of the trial.\n\n   Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial.\n5. Negative serum β-HCG (beta-human chorionic gonadotropin) test for women of child-bearing potential at Screening and a negative urine pregnancy test prior to randomization on Day 1.\n6. Able and willing to provide written informed consent and comply with trial protocol.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP\n2. Estimated glomerular filtration rate (\\[e\\]GFR) \\<30 mL/minute/1.73 m2 at screening\n3. Alanine transaminase (ALT) \\>2×upper limit of normal (ULN) or direct bilirubin \\>1.1×ULN (except Gilbert's Disease) at screening\n4. Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period\n5. Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)\n6. Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment.\n7. Participants who received antibody-depletion therapy within 3 months prior to randomization, or in the opinion of the Investigator are likely to require antibody-depletion therapy during trial participation. Antibody-depletion therapies include but are not necessarily limited to plasmapheresis, immunoadsorption, and intravenous immunoglobulins (IVIg)\n8. Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \\[FSGS\\], C3 glomerulopathy)\n9. Participants with known donor-specific antibodies (\\[DSA\\], de novo, or pre-transplantation). Kidney transplant recipients with low-level pretransplant DSAs (\\<1,000 mean fluorescence intensity \\[MFI\\]) can be included if no impact on the trial assessments is expected by the discretion of the Investigator.\n10. Pregnant or nursing (lactating) women\n11. Uncontrolled acute or chronic infections such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), cytomegalovirus (CMV), or Epstein-Barr virus (EBV)\n12. History of malignancy within the past 5 years, except completely excised basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ at least 2 years prior to screening\n13. Documented evidence of the use of another Investigational Medicinal Product (IMP) within 30 days or 5 half-lives of randomization, or until the expected PD effect has returned to baseline (whichever is longer)\n14. Known current alcoholism or drug addiction\n15. Any other condition or laboratory abnormality, that in the opinion of the Investigator, would interfere with the evaluation of the IMP or interpretation of the participant safety data or trial results.","locations":[{"facility":"University of Alabama at Birmingham Hospital","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Keck Hospital of University of Southern California (USC)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA College of Medicine","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Medical Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barnes-Jewish Hospital - St. Louis (Washington University Medical Campus)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cooperman Barnabas Medical Center","city":"Livingston","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York-Presbyterian - Weill Cornell Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest School of Medicine","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center (UPMC)","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Frequency and severity of treatment-emergent adverse events (TEAEs)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","los-angeles-california","tampa-florida","atlanta-georgia","chicago-illinois","baltimore-maryland","st-louis-missouri","livingston-new-jersey","new-york-new-york","winston-salem-north-carolina","cleveland-ohio","pittsburgh-pennsylvania","dallas-texas"],"enrichment":{"headline":"Phase 2: testing AIC263029 for BK Virus Infection","inPlainEnglish":"The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia). The study will also examine how the body processes AIC263029 and whether it lowers BKV levels in the blood.","whoItsFor":["Ages 18 Years to any","Male or female aged 18 years or older","Kidney transplantation within 12 months prior to randomization","First episode of detectable BKV DNA in plasma since last kidney transplantation. As defined by either:","positive BKV DNA test of one time \\>104 IU/mL and \\<106 IU/mL, within 30 days prior to randomization, or","\\>103 IU/mL and ≤104 IU/mL sustained for at least 2 weeks (confirmed by at least 2 consecutive measurements), with the most recent measurement within 14 days prior to randomization","Female participants (if of childbearing potential) must agree to remain abstinent (refrain from heterosexual intercourse) or use at least one highly effective contraceptive method that result in a failure rate of \\<1% per year until the end of the trial","Male participants must agree to refrain from donating sperm, and to remain abstinent (refrain from heterosexual intercourse) or use a condom with a female partner of childbearing potential until the end of the trial"],"whoShouldSkip":["Known hypersensitivity to any component of the IMP","Estimated glomerular filtration rate (\\[e\\]GFR) \\<30 mL/minute/1.73 m2 at screening","Alanine transaminase (ALT) \\>2×upper limit of normal (ULN) or direct bilirubin \\>1.1×ULN (except Gilbert's Disease) at screening","Uncontrolled participants who are treated or planned to be treated with an mTOR inhibitor or belatacept as part of their immunosuppression regimen post-transplantation at the time of enrollment and during the trial period","Participants who have received a multi-organ transplant involving a kidney (e.g. kidney-pancreas, kidney-liver, kidney-heart)","Participants who are treated or planned to be treated during trial participation with leflunomide, cidofovir, or medicinal products potentially active against BKV at the time of randomization and during the trial period until end of treatment","Participants with active kidney transplant rejection or those considered at high-risk of recurrence of native kidney disease (e.g. primary focal segmental glomerulosclerosis \\[FSGS\\], C3 glomerulopathy)"],"whatHappens":"If you join, the listed intervention(s) are AIC263029, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if AIC263029 is safe and well tolerated in adult kidney transplant recipients with BK virus (BKV) in the blood (viremia).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 24 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.061Z"},{"nctId":"NCT07503808","title":"A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types","officialTitle":"An Open-Label, Multicenter Study Evaluating the Safety, Efficacy, and Pharmacokinetics of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"IDEAYA Biosciences","sponsorClass":"INDUSTRY","summary":"This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.","conditions":["Esophageal Squamous Cell Carcinoma","High Grade Serous Ovarian Cancer","Head and Neck Squamous Cell Carcinoma","Colorectal Cancer","Castration-resistant Prostate Cancer","Non Small Cell Lung Cancer","Endometrium Cancer","Triple Negative Breast Cancer"],"keywords":["Esophageal Squamous Cell Carcinoma","ESCC","Endometrial Cancer","Head and Neck Squamous Cell Carcinoma","HNSCC","Triple-negative Breast Cancer","TNBC","Colorectal Cancer","CRC","Non-small Cell Lung Cancer","NSCLC","High-grade Serous Ovarian Cancer","HGSOC","Advanced, Metastic Solid Tumors","B7-H3 (CD276) and Protein Tyrosine Kinase 7 (PTK7)","IDE034"],"interventions":[{"type":"DRUG","name":"IDE034"}],"enrollment":150,"startDate":"2026-02-24","completionDate":"2027-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant must be at least 18 years of age or the age of maturity per local regulations\n2. Participants with advanced recurrent or metastatic solid tumors expressing B7-H3 and PTK7 in the following indications: NSCLC, ESCC, endometrial cancer, HGSOC, HNSCC, TNBC (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 \\[HER2\\] negative), CRC, and CRPC who have radiologically progressed or recurred on at least one line of therapy or is intolerant to additional effective standard therapies.\n3. Archival tissue sample for testing\n4. Measurable disease\n5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n6. Have adequate bone marrow and organ function.\n7. Able to comply with contraceptive/barrier requirements\n\nExclusion Criteria:\n\n1. Known symptomatic brain metastases or leptomeningeal metastasis\n2. Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose.\n3. Have uncontrolled tumor-associated pain\n4. Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose\n5. Active uncontrolled infection\n6. Have history of interstitial pneumonitis, current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose.\n7. Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization.\n8. Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening.\n9. Participants with known or suspected viral hepatitis\n10. Have history of active tuberculosis within 1 year before enrollment\n11. If participants had adverse reactions to previous antitumor treatment that have not recovered to guidelines of CTCAE Grade ≤ 1 and Grade 2 peripheral neurological symptoms\n12. Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 3 weeks before the first dose of IMP or other investigational products within 4 weeks of first dose of IMP\n13. Administration of any of the following\n\n    1. Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers\n    2. Have prior treatment with B7-H3 or PTK7 antibody-drug conjugate (ADC).\n    3. Have prior treatment with a topoisomerase I inhibitor (TOP1i), including an ADC with a TOP1i payload, within 6 months of first dose of IMP\n    4. Have received radiotherapy within 2 weeks prior to study entry\n    5. Have undergone major surgery or trauma within 4 weeks prior to study entry.\n    6. Have received live attenuated vaccine within 28 days prior to the first dose or are expected to receive live attenuated vaccine during the study treatment.\n    7. Female participants who are pregnant, lactating, or planning to become pregnant during the study period to 7 months after the last dose of IMP.\n    8. Are known to be allergic to any component or excipient of the IMP product or have a history of severe allergic reactions to other monoclonal antibody/fusion protein drugs.\n    9. Participants with complications in the eye including ulcers in the eye, and severe dry eye","locations":[{"facility":"City of Hope Comprehensive Cancer Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope Orange County Lennar Foundation Cancer Center","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at HealthONE","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Celebration","city":"Celebration","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Clinical Trials Group","city":"Plantation","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karmanos Cancer Institute","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START New Jersey","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START New York Long Island, LLC","city":"Lake Success","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Texas LLC - Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Dallas Fort Worth, LLC","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Texas LLC - Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Texas LLC - Dallas","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Texas LLC - San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START San Antonio, LLC","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Mountain Region, LLC","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Texas LLC - Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Associates","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LTD High Technology Hospital Medcenter","city":"Batumi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Multiprofile Clinic Consilium Medulla","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Rioja - Hospital Universitario San Pedro","city":"Logroño","state":"La Rioja","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid - Hospital Universitario HM Sanchinarro - CIOCC","city":"Madrid","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"IDEAYA Clinical Trials","phone":"1-855-433-2246","email":"IDEAYAClinicalTrials@ideayabio.com"}],"primaryOutcomes":["Safety and tolerability of IDE034 in Part 1 dose escalation","Safety and tolerability of IDE034 in Part 2 dose expansion","To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion","To evaluate preliminary anti-tumor activity of IDE034 in Part 2 dose expansion"],"hasResults":false,"conditionSlugs":["breast-cancer","prostate-cancer","lung-cancer","colorectal-cancer","ovarian-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["duarte-california","irvine-california","denver-colorado","new-haven-connecticut","celebration-florida","plantation-florida","sarasota-florida","detroit-michigan","east-brunswick-new-jersey","lake-success-new-york","new-york-new-york","nashville-tennessee","austin-texas","fort-worth-texas","houston-texas","irving-texas","san-antonio-texas","west-valley-city-utah","fairfax-virginia","spokane-washington","batumi-georgia","tbilisi-georgia","logro-o-spain","madrid-spain"],"enrichment":{"headline":"Phase 1: testing IDE034 for Esophageal Squamous Cell Carcinoma","inPlainEnglish":"This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to measure the safety, PK, immunogenicity and preliminary how well it works of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.","whoItsFor":["Ages 18 Years to any","Participant must be at least 18 years of age or the age of maturity per local regulations","Archival tissue sample for testing","Have Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1","Have adequate bone marrow and organ function","Able to comply with contraceptive/barrier requirements"],"whoShouldSkip":["Known symptomatic brain metastases or leptomeningeal metastasis","Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose","Have uncontrolled tumor-associated pain","Have clinically significant cardiac abnormalities and/or cerebrovascular disease (stroke) within 6 months before the first dose","Active uncontrolled infection","Have history of severe infections within 4 weeks prior to the start of study treatment, including but not limited to bacteremia, severe pneumonia, or other serious infectious complications requiring hospitalization","Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening"],"whatHappens":"If you join, the listed intervention(s) are IDE034. The registry lists allocation as randomized. This is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to measure the safety, PK, immunogenicity and preliminary how well it works of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 150 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.964Z"},{"nctId":"NCT07504588","title":"Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy","officialTitle":"A Randomized Phase II Trial of Sacituzumab Govitecan-HZIY (SG) and Bevacizumab Versus Standard of Care Carboplatin, Pegylated Liposomal Doxorubicin (PLD) and Bevacizumab in Patients With Platinum-Sensitive Ovarian Cancer That Has Progressed on Prior Maintenance PARP Inhibitor Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan. Sacituzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers govitecan to kill them. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving sacituzumab govitecan and bevacizumab may kill more tumor cells than standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with recurrent platinum-sensitive ovarian cancers that have BRCA1/2 mutations or homologous recombination deficiency.","conditions":["Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma","Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma","Recurrent Platinum-Sensitive Ovarian High Grade Endometrioid Adenocarcinoma","Recurrent Platinum-Sensitive Ovarian High Grade Serous Adenocarcinoma","Recurrent Platinum-Sensitive Primary Peritoneal Endometrioid Adenocarcinoma","Recurrent Platinum-Sensitive Primary Peritoneal High Grade Serous Adenocarcinoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Anti-VEGF Monoclonal Antibody"},{"type":"BIOLOGICAL","name":"Bevacizumab"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"DRUG","name":"Carboplatin"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"Gemcitabine"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Pegylated Liposomal Doxorubicin Hydrochloride"},{"type":"BIOLOGICAL","name":"Sacituzumab Govitecan"}],"enrollment":87,"startDate":"2026-09-24","completionDate":"2029-04-12","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients must have histologic diagnosis of high grade serous or endometrioid epithelial ovarian cancer\n\n  * Ovarian cancer = fallopian tube, ovarian, and primary peritoneal cancer\n* Disease must be platinum sensitive, as defined by progression documented ≥ 6 months (182 days) from the last receipt of platinum\n* Disease must have progressed during first line maintenance PARP inhibitor (PARPi) for advanced ovarian cancer. NO intervening therapies between progression on PARPi and study registration are permitted\n* Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive\n* Disease must be measurable or non-measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1\n* Secondary or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted\n* No previous receipt of any topoisomerase-I inhibiting agents\n* No investigational agents within 4 weeks of study registration\n* No current treatment with any other (non-study) cytotoxic chemotherapy, targeted therapy, biologic therapy, immunotherapy or endocrine therapy for the treatment of the disease under the current study\n* Last dose of PARP inhibitor treatment must be ≥ 3 weeks before study registration\n* Patients with treated brain metastases are eligible if follow-up brain imaging 4 weeks after CNS-directed therapy shows no evidence of disease progression. Patients with brain metastases must have follow up imaging demonstrating no evidence of disease progression and that the disease is stable off of steroids\n* Age ≥ 18\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* Not pregnant and not nursing\n* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\\^3\n* Platelets ≥ 100,000 cells/mm\\^3\n* Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \\[Hgb\\] ≥ 9 g/dl is acceptable)\n* Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula\n* Urinalysis with ≤ 1+ protein and/or urine protein \\< 1.0 g/24 hours (hrs)\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification. To be eligible for this trial, patients should be class 2B or better\n* No active infection requiring parenteral antibiotics\n* No non-healing wound, ulcer, or bone fracture\n* No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube\n* No clinically significant bleeding within 28 days prior to registration\n* No uncontrolled hypertension, defined as systolic ≥ 160 mm Hg or diastolic ≥ 100 mm Hg\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the following exceptions:\n\n  * Patients with grade 2 or lower neuropathy, any grade alopecia, well controlled hypertension, thyroid disease controlled with therapy, and history of thromboembolic disease on anticoagulation are eligible\n  * Patients with laboratory-based grade 2 or higher adverse events (AEs) that meet the criteria outlined above are eligible\n* No major surgery within 3 weeks prior to study registration\n* Patients who underwent major surgery must have recovered adequately from any toxicity and/or complications from surgery prior to study registration\n* No strong inhibitors or inducers of UGT1A1\n* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)","locations":[{"facility":"Highlands Oncology Group - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group - Rogers","city":"Rogers","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highlands Oncology Group","city":"Springdale","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Health - Coeur d'Alene","city":"Coeur d'Alene","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Post Falls","city":"Post Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kootenai Clinic Cancer Services - Sandpoint","city":"Sandpoint","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle at The Riverfront","city":"Danville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Effingham","city":"Effingham","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Physician Group-Mattoon/Charleston","city":"Mattoon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle BroMenn Medical Center","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Institute Normal","city":"Normal","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carle Cancer Center","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates at Mercy Medical Center","city":"Cedar Rapids","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital Springfield","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Hospital of Anaconda","city":"Anaconda","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic Cancer Center","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Benefis Sletten Cancer Institute","city":"Great Falls","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Logan Health Medical Center","city":"Kalispell","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Medical Center","city":"Missoula","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monmouth Medical Center","city":"Long Branch","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Progression-free survival"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["fayetteville-arkansas","rogers-arkansas","springdale-arkansas","coeur-dalene-idaho","post-falls-idaho","sandpoint-idaho","danville-illinois","effingham-illinois","mattoon-illinois","normal-illinois","urbana-illinois","cedar-rapids-iowa","springfield-missouri","anaconda-montana","billings-montana","great-falls-montana","kalispell-montana","missoula-montana","long-branch-new-jersey","new-brunswick-new-jersey","oklahoma-city-oklahoma"],"enrichment":{"headline":"Phase 2: testing Anti-VEGF Monoclonal Antibody for Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma","inPlainEnglish":"This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient. Sacituzumab govitecan is a monoclonal antibody, called sacituzumab, linked to a drug called govitecan.","whoItsFor":["Ages 18 Years to any","Women only","Patients must have histologic diagnosis of high grade serous or endometrioid epithelial ovarian cancer","Ovarian cancer = fallopian tube, ovarian, and primary peritoneal cancer","Disease must be platinum sensitive, as defined by progression documented ≥ 6 months (182 days) from the last receipt of platinum","Disease must have progressed during first line maintenance PARP inhibitor (PARPi) for advanced ovarian cancer. NO intervening therapies between progression on PARPi and study registration are permitted","Disease must be germline or somatic BRCA1 or BRCA2 mutated or homologous recombination deficiency test positive","Disease must be measurable or non-measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1","Secondary or cytoreductive surgery, after start of treatment on this trial, and prior to documentation of disease progression, is NOT permitted"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Anti-VEGF Monoclonal Antibody, Bevacizumab, or Biospecimen Collection. The registry lists allocation as randomized. This phase II trial compares the effect of sacituzumab govitecan and bevacizumab to standard care (carboplatin, pegylated liposomal doxorubicin, and bevacizumab) in patients with ovarian cancer that has come back after an initial response to platinum therapy (platinum-sensitive), that has progressed after poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor maintenance therapy (recurrent), and that has a mutation in the BRCA1 or BRCA2 genes or is homologous recombination deficient.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 87 people at 23 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.162Z"},{"nctId":"NCT07507435","title":"Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults","officialTitle":"Optimizing Medications and Lung Health in People With HIV Through Pharmacist-led Proactive E-Consults (OPTIMIZE Lung-HIV)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Seattle Institute for Biomedical and Clinical Research","sponsorClass":"OTHER","summary":"People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality. Several modifiable factors increase this risk, including active smoking, inadequate receipt of respiratory vaccinations, and inappropriate or prolonged use of inhaled corticosteroids (ICS) or proton-pump inhibitors (PPIs).\n\nOPTIMIZE Lung-HIV is a multicenter, patient-level randomized controlled hybrid Type 1 effectiveness-implementation trial evaluating whether a proactive, pharmacist-led E-consult intervention can improve evidence-based pulmonary pharmacotherapy for PWH. Pharmacists will review electronic health records, generate tailored recommendations, and pre-enter orders related to smoking cessation pharmacotherapy, vaccinations, and deprescribing of ICS or PPIs. Providers may enact or modify recommendations as clinically appropriate.\n\nThe trial will assess the proportion of recommendations enacted within 3 months (primary outcome) and at 12 months (maintenance) and will use mixed methods guided by CFIR and RE-AIM to evaluate adoption, feasibility, acceptability, and implementation barriers and facilitators.","conditions":["HIV","Inhaled Corticosteroid","Proton Pump Inhibitor","Smoking Cessation","Pneumonia"],"keywords":["Pharmacist","E-consult","HIV"],"interventions":[{"type":"OTHER","name":"E-consult"}],"enrollment":480,"startDate":"2026-09-24","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PWH with an active prescription of ART any time in past 6 months and \\<200 copies/mL within past 12 months, actively receiving care at the VA, and one of the following:\n\n  1. Actively smoking\n  2. Prescribed ICS for \\>90 days\n  3. Prescribed a PPI for \\>90 days\n\n     Exclusion Criteria:\n* Enrolled in palliative care or hospice\n* If a non-VA provider is the main primary care or HIV provider\n* Are currently participating in a separate ongoing interventional clinical trial","locations":[{"facility":"Boise VA Medical Center","city":"Boise","state":"Idaho","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis VA Health Care System","city":"Minneapolis","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"VA Puget Sound Health Care System","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"John R Kundzins, BS","phone":"206-277-1182","email":"OPTIMIZEStudyTeam@va.gov"}],"primaryOutcomes":["Proportion of recommended medication changes enacted within 3 months"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["boise-idaho","minneapolis-minnesota","seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: E-consult for HIV","inPlainEnglish":"People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy. Pneumonia contributes to hospitalization, respiratory failure, cardiovascular complications, long-term decline in lung function, and mortality.","whoItsFor":["Ages 18 Years to any","PWH with an active prescription of ART any time in past 6 months and \\<200 copies/mL within past 12 months, actively receiving care at the VA, and one of the following:","Prescribed ICS for \\>90 days","Prescribed a PPI for \\>90 days"],"whoShouldSkip":["Enrolled in palliative care or hospice","If a non-VA provider is the main primary care or HIV provider","Are currently participating in a separate ongoing treatment clinical trial"],"whatHappens":"If you join, the listed intervention(s) are E-consult. The registry lists allocation as randomized. People with HIV (PWH) continue to experience elevated risk of community-acquired pneumonia despite effective antiretroviral therapy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 480 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.527Z"},{"nctId":"NCT07510191","title":"TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response","officialTitle":"Efficacy and Safety of Standard-Dose TNF Inhibitor Plus Low-Dose Upadacitinib Versus TNF Inhibitor Intensification for Crohn's Disease With Suboptimal Response to Standard-Dose TNF Inhibitors: A Multicenter, Randomized, Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","sponsorClass":"OTHER","summary":"This multicenter, randomized, controlled trial aims to evaluate the efficacy and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment. Participants will be randomly assigned in a 1:1 ratio to either continue standard-dose TNFi with oral upadacitinib 15 mg once daily, or receive TNFi dose intensification according to the protocol. Clinical assessments will be performed at baseline and during follow-up, with the primary endpoint assessed at Week 14. The primary outcome is the proportion of participants achieving clinical remission, defined as a Crohn's Disease Activity Index (CDAI) score \\<150 at Week 14. Secondary outcomes include clinical response, endoscopic response and remission, changes in inflammatory biomarkers such as C-reactive protein and fecal calprotectin, quality of life, and safety outcomes including adverse events and serious adverse events. Participants will continue follow-up after Week 14 to evaluate treatment durability and longer-term safety. This study is designed to determine whether a dual-target strategy with standard-dose TNFi plus low-dose upadacitinib provides superior short-term efficacy and acceptable safety compared with conventional TNFi intensification in Crohn's disease patients with insufficient benefit from standard-dose TNFi therapy.","conditions":["Crohn Disease (CD)"],"keywords":["Crohn Disease","TNF inhibitor","Infliximab","Adalimumab","Upadacitinib","Dose intensification","Dual-target therapy","Multicenter randomized controlled trial"],"interventions":[{"type":"DRUG","name":"Upadacitinib"},{"type":"DRUG","name":"Infliximab Dose Intensification"},{"type":"DRUG","name":"Adalimumab Dose Intensification"},{"type":"DRUG","name":"Standard-Dose infliximab"},{"type":"DRUG","name":"Standard-Dose Adalimumab"}],"enrollment":312,"startDate":"2026-03-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment:\n\n1. Age 18-65 years, regardless of sex.\n2. Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria.\n3. Prior exposure to TNFα inhibitors (including infliximab, adalimumab, or its biosimilars) for at least 12 weeks, and currently receiving a standard-dose treatment regimen. After comprehensive evaluation by the investigators, the participant is considered to have partial response to TNFα inhibitor therapy with residual room for optimization. This is defined as failure to achieve the prespecified treatment target after standard induction and/or maintenance therapy, while still being considered by the investigator to have potential for further optimization. Eligible participants should meet either of the following: (1)Loss of response (LOR): The participant previously achieved clinical remission and/or objective improvement after TNFα inhibitor treatment, but subsequently developed recurrent disease activity during the maintenance phase. Based on the prior response trajectory, current objective evidence of disease activity, treatment adherence, and available reactive therapeutic drug monitoring (TDM) results, the investigator judges that the participant has not developed complete pharmacodynamic failure to TNFi, and still has room for further therapeutic optimization. (2)Primary inadequate response: After completion of standard induction therapy, the participant achieved some but insufficient improvement compared with pretreatment baseline, defined as meeting at least one of the following: ①CDAI decrease of ≥100 points, but CDAI remains ≥150, ②SES-CD decrease of ≥50%, but active ulcerative lesions persist or endoscopic remission has not been achieved, ③CRP and/or FCP decrease of ≥50%, but inflammatory markers have not normalized (e.g., FCP ≥250 μg/g), ④Based on a comprehensive assessment of symptoms, endoscopy, inflammatory biomarkers, and imaging, the investigator determines that the participant has achieved partial response to TNFi but has not reached the anticipated treatment target, with further room for optimization.\n4. Active Crohn's disease with objective evidence of active inflammation, defined as meeting all of the following: 150 ≤ CDAI \\< 450; at least one of the following objective indicators of active inflammation: (1)Endoscopy showing active ulcerative lesions, (2)Elevated inflammatory markers such as C-reactive protein (CRP), (3)Fecal calprotectin (FCP) ≥250 μg/g, (4)Imaging evidence of active intestinal inflammation, such as CTE, MRE, or intestinal ultrasound.\n5. At enrollment, the participant must simultaneously meet both requirements:\n\n   Partial response to TNFα inhibitor therapy with residual room for optimization, and\n6. Objective evidence of active inflammation at the current active stage of CD. Baseline TDM and pharmacokinetic assessment are feasible at enrollment, and relevant results may be used for baseline stratification, efficacy analysis, and exploratory research.\n7. The participant fully understands the study objectives, procedures, and potential risks, voluntarily agrees to participate, and has signed the written informed consent form.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization.\n2. Documented immunogenic clearance confirmed by therapeutic drug monitoring (TDM), defined as positive anti-drug antibodies against a TNFα inhibitor with extremely low or undetectable trough drug levels, and judged by the investigator to be unsuitable for continued treatment with the original TNFα inhibitor.\n3. Current symptoms are judged, after comprehensive evaluation, to be caused primarily by non-inflammatory factors, with no objective evidence of active inflammation, such as irritable bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, or other non-inflammatory causes.\n4. Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment.\n5. Presence of severe intestinal complications rendering the participant unsuitable for this study, including but not limited to inadequately controlled active intra-abdominal abscess, intestinal perforation, severe stricture requiring urgent surgical intervention, or severe active intestinal fistula.\n6. Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect efficacy assessment or safety evaluation.\n7. Active infection or high risk of severe infection, including but not limited to active tuberculosis, uncontrolled serious bacterial/fungal/viral infection, active herpes zoster, HBV reactivation, HIV infection, or other clinically significant immunodeficiency states.\n8. Severe dysfunction of major organs, such as significant hepatic impairment, severe renal insufficiency, severe cardiac insufficiency, or other serious underlying diseases judged by the investigator to make participation inappropriate.\n9. History of gastrointestinal malignancy, or presence of any other malignant disease that may significantly affect study safety or efficacy assessment.\n10. Pregnant or breastfeeding women, or women planning pregnancy who are unwilling to use effective contraception during the study period.\n11. Severe psychiatric or neurologic disorders that may impair the ability to provide informed consent, adhere to treatment, or complete study follow-up.\n12. Participation in another interventional clinical study within 30 days prior to enrollment, where the prior intervention may affect the efficacy or safety assessment of this study.\n13. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment in this study.","locations":[{"facility":"The Sixth Affiliated Hospital, Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Wang, MD","phone":"86-18702046420","email":"wangw239@mail.sysu.edu.cn"}],"primaryOutcomes":["Clinical remission rate"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 4: testing Upadacitinib for Crohn Disease (CD)","inPlainEnglish":"This multicenter, randomly assigned, controlled trial aims to measure the how well it works and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy. Eligible participants are adults with active Crohn's disease receiving standard-dose infliximab or adalimumab who remain inadequately controlled despite ongoing treatment.","whoItsFor":["Ages 18 Years to 65 Years","Participants must meet all of the following criteria to be eligible for enrollment:","Age 18-65 years, regardless of sex","Established diagnosis of Crohn's disease (CD) based on a comprehensive assessment including clinical manifestations, imaging, endoscopy, histopathology, and other relevant evaluations, and meeting currently accepted domestic and international diagnostic criteria","At enrollment, the participant must simultaneously meet both requirements:","Partial response to TNFα inhibitor therapy with residual room for optimization, and","Objective evidence of active inflammation at the current active stage of CD. Baseline TDM and pharmacokinetic assessment are feasible at enrollment, and relevant results may be used for baseline stratification, how well it works analysis, and exploratory research"],"whoShouldSkip":["Participants meeting any of the following criteria will be excluded from the study:","No improvement at all after adequate induction therapy with a TNFα inhibitor, with investigator judgment indicating clear mechanistic non-response and minimal likelihood of benefit from further optimization","Prior exposure to JAK inhibitors (including but not limited to upadacitinib), known hypersensitivity to any component of the investigational treatment, or other clear contraindications to study treatment","Major bowel resection, stoma creation, or other major abdominal surgery within 3 months prior to enrollment, if judged by the investigator to affect how well it works assessment or safety evaluation","Active infection or high risk of severe infection, including but not limited to active tuberculosis, uncontrolled serious bacterial/fungal/viral infection, active herpes zoster, HBV reactivation, HIV infection, or other clinically significant immunodeficiency states","Severe dysfunction of major organs, such as significant hepatic impairment, severe renal insufficiency, severe cardiac insufficiency, or other serious underlying diseases judged by the investigator to make participation inappropriate","History of gastrointestinal malignancy, or presence of any other malignant disease that may significantly affect study safety or how well it works assessment"],"whatHappens":"If you join, the listed intervention(s) are Upadacitinib, Infliximab Dose Intensification, or Adalimumab Dose Intensification. The registry lists allocation as randomized. This multicenter, randomly assigned, controlled trial aims to measure the how well it works and safety of standard-dose tumor necrosis factor inhibitor (TNFi) plus low-dose upadacitinib compared with TNFi dose intensification in patients with moderate-to-severe Crohn's disease who have a suboptimal response to standard-dose TNFi therapy.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 312 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.271Z"},{"nctId":"NCT07510607","title":"Hyperpolarized Carbon Metabolic Imaging in Multiple Sclerosis","officialTitle":"Assessing Metabolic Changes in Multiple Sclerosis Using Hyper-polarized Carbon 13 MRI","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Ari Green","sponsorClass":"OTHER","summary":"The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression.\n\nThis method of imaging utilizes the Warburg effect, where innate immune cells utilize a metabolic shift to glycolysis instead of oxidative phosphorylation. In pre-clinical data, increased hyperpolarized lactate production has been found to be associated with increased microglial/macrophage infiltration in the brain. Although hyperpolarized carbon imaging in humans has been established and used in the field of oncology, this will be one of the first applications of hyperpolarized carbon the study of neuroinflammation in humans. We predict that hyperpolarized carbon imaging may have the potential to monitor and evaluate neuroinflammation in MS, and in particular the innate immune activation state that plays a role in MS progression. This imaging method may provide non-invasive monitoring of disease progression and therapy response for MS patients.","conditions":["Multiple Sclerosis","RRMS","Relapsing Remitting MS"],"keywords":["Hyperpolarized Carbon","Multiple Sclerosis","Anti-CD20","Ocrevus","RRMS","MS","Metabolic Imaging","Hyperpolarized Pyruvate","MRI","Magnetic Resonance Imaging","UCSF","Ari Green","Relapsing Remitting MS","ocrelizumab","Jeremy Gordon","MS biomarker","MS prognosis"],"interventions":[{"type":"DRUG","name":"HP 13C pyruvate injection"},{"type":"DEVICE","name":"MRI Scanner"}],"enrollment":40,"startDate":"2026-06-03","completionDate":"2029-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Subjects must be 18 years or older.\n2. Relapsing remitting MS, naïve to DMTs for the past two years minimum\n3. Patients must be naive to anti-CD20 therapy with plans to begin the therapy as part of their physician's multiple sclerosis treatment plan. The patients must remain on a form of anti-CD20 therapy for the entirety of their enrollment in the study.\n4. Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane.\n\nExclusion criteria:\n\n1. Treatment with corticosteroids within 30 days prior to screening.\n2. Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.\n3. Poorly controlled hypertension, defined as either systolic \\>160 or diastolic \\>110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination.\n4. Congestive Heart Failure ≥ NYHA Class II.\n5. History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome.\n6. Myocardial infarction within 6 months of study entry.\n7. Individuals who are pregnant. Individuals of childbearing potential (defined below) must agree to undergo a urine pregnancy test prior to participating in the study scans. Pregnant individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn child secondary to administration of HP 13C pyruvate to the study participant.\n\n   A female is considered to not be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).\n8. Individuals who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant.\n\n   Breastfeeding/chestfeeding should be discontinued before administration of HP 13C pyruvate.\n9. Known hypersensitivity to HP 13C pyruvate or any of its excipients.\n10. History of cancer within five years of enrollment date and/or history of chemotherapy within two years of enrollment date.\n11. Any dental braces or permanent or undetachable metals in the jaw or face.\n12. Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases that in the PI's judgment may affect the interpretation of study results or patient safety.\n13. Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.\n14. Glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m² on baseline visit or subsequent study visits, history of kidney disease or history of hypersensitivity to gadolinium contrast agent.\n15. Baseline EDSS \\>6.5","locations":[{"facility":"Byers Hall","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["To determine the percent changes in MS lesions, white matter, and whole brain HP 13C pyruvate metabolism measures between the pre-treatment scan and the scan obtained 1.5-months following treatment initiation."],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Phase 2: testing HP 13C pyruvate injection for Multiple Sclerosis","inPlainEnglish":"The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy. Study procedures will include magnetic resonance imaging (MRI) assessments with a hyperpolarized pyruvate sequence, clinical assessment as well as blood markers of disease progression.","whoItsFor":["Ages 18 Years to any","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Subjects must be 18 years or older","Relapsing remitting MS, naïve to DMTs for the past two years minimum","Patients must be who have not tried this kind of treatment before to anti-CD20 therapy with plans to begin the therapy as part of their physician's multiple sclerosis treatment plan. The patients must remain on a form of anti-CD20 therapy for the entirety of their enrollment in the study","Patients enrolled will be screened for at least one MS lesion with a 10mm diameter in one plane"],"whoShouldSkip":["Treatment with corticosteroids within 30 days prior to screening","Patients unwilling or unable to undergo MR imaging, including patients with contra-indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips","Poorly controlled hypertension, defined as either systolic \\>160 or diastolic \\>110. The addition of anti-hypertensives to control blood pressure is allowed for eligibility determination","Congestive Heart Failure ≥ NYHA Class II","History of clinically significant EKG abnormalities, including QT prolongation or a family history of prolonged QT syndrome","Myocardial infarction within 6 months of study entry","Individuals who are breastfeeding/chestfeeding. Breastfeeding/chestfeeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to administration of HP 13C pyruvate to the study participant"],"whatHappens":"If you join, the listed intervention(s) are HP 13C pyruvate injection, or MRI Scanner. The registry lists allocation as na. The main purpose of this study is to assess whether hyperpolarized carbon imaging in relapsing remitting multiple sclerosis (MS) patients can be used to predict response to anti-CD20 disease modifying therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at San Francisco. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.993Z"},{"nctId":"NCT07511166","title":"A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation","officialTitle":"High-quality Pulmonary Veins Isolation Using Varipulse Catheter Under Contact and Continuity Guidance in Patients With Paroxysmal Atrial Fibrillation Under Optimized Sedation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Johnson & Johnson Medical (Shanghai) Ltd.","sponsorClass":"INDUSTRY","summary":"The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[],"enrollment":300,"startDate":"2026-10-12","completionDate":"2028-07-28","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records\n* Age 18-80 years\n* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements\n* Signed patient informed consent form (ICF)\n\nExclusion criteria:\n\n* Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause\n* Previous left atrium (LA) ablation or surgery\n* Left atrium diameter (LAD) greater than (\\>) 50 millimeters (mm) by transthoracic echocardiography (TTE)\n* Left ventricular ejection fraction (LVEF) less than (\\<) 40 percent (%)\n* Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* Presenting contra-indications for the devices used in the study, as indicated in the respective instructions for use (IFU)\n* Presenting contra-indications for catheter ablation at physicians' discretion, for example LA/Left atrial appendage (LAA) thrombus, systematic infection, situations preventing catheter access\n* Other conditions that, at discretion of the investigators, would preclude enrollment in this study","locations":[{"facility":"Zhongshan Hospital Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"YanTing Zhang","phone":"13162835013","email":"yzhan365@ITS.JNJ.com"}],"primaryOutcomes":["Freedom From Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmias Episode"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"A Study of Varipulse Catheter in Participants With Paroxysmal Atrial Fibrillation Under Optimized Sedation","inPlainEnglish":"The main purpose of the study is to assess how well the standard ablation procedure (Varipulse Catheter) works over long term when used with different types of anesthesia in participants with symptomatic paroxysmal atrial fibrillation (PAF, irregular heartbeat that comes and goes on its own, causing noticeable symptoms like a racing heart, or shortness of breath).","whoItsFor":["Ages 18 Years to 80 Years","Diagnosed with I and/or III antiarrhythmic drugs (AAD)-refractory symptomatic paroxysmal atrial fibrillation (PAF) or intolerable to class I and/or III AAD based on medical records"],"whoShouldSkip":["Atrial fibrillation (AF) secondary to electrolyte imbalance, hyperthyroidism, or reversible or non-cardiac cause","Previous left atrium (LA) ablation or surgery","Left atrium diameter (LAD) greater than (\\>) 50 millimeters (mm) by transthoracic echocardiography (TTE)","Left ventricular ejection fraction (LVEF) less than (\\<) 40 percent (%)","Known significant pulmonary vein (PV) anomaly that in the opinion of the investigator would preclude enrollment in this study","Current enrollment in an investigational study evaluating another device or drug","Women who are pregnant (as evidenced by pregnancy test or oral confirmation if pre-menopausal), lactating, or who are of childbearing age and plan on becoming pregnant during the course of the clinical investigation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.743Z"},{"nctId":"NCT07511205","title":"A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participants Living With Overweight and/or Obesity.","officialTitle":"A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD1043 Following Single and Multiple Ascending Doses Via Subcutaneous and/or Intravenous Administration in Healthy Adult Participants Living With Overweight and/or Obesity.","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.","conditions":["Healthy Participants","Obesity"],"keywords":["First time in human","Single ascending dose","Multiple ascending dose","Pharmacokinetics","Pharmacodynamics"],"interventions":[{"type":"DRUG","name":"AZD1043"},{"type":"OTHER","name":"Placebo"}],"enrollment":104,"startDate":"2026-03-30","completionDate":"2027-04-09","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.\n* Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy.\n* Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts \\[Parts A1 and B1\\]), or 23 and 39.9 kg/m2 (Japanese \\[Parts A2 and B2\\] and Chinese \\[Part A3\\] cohorts) inclusive and weigh at least 50 kg.\n* For the Parts A2 and B2, participants should be Japanese (natives of Japan or Japanese Americans), having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.\n* For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.\n* Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs.\n* History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043.\n* Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit.\n* History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable.","locations":[{"facility":"Research Site","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Brooklyn","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Harrow","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Number of participants with adverse events (AEs), serious adverse events (SAEs), AE leading to discontinuation (DAEs), and AEs of special interest (AESIs)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["glendale-california","brooklyn-maryland","harrow-united-kingdom"],"enrichment":{"headline":"Phase 1: testing AZD1043 for Healthy Participants","inPlainEnglish":"The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.","whoItsFor":["Ages 18 Years to 65 Years","All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit","Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy","Have a body mass index between 25 and 39.9 kg/m2 (Global cohorts \\[Parts A1 and B1\\]), or 23 and 39.9 kg/m2 (Japanese \\[Parts A2 and B2\\] and Chinese \\[Part A3\\] cohorts) inclusive and weigh at least 50 kg","For the Part A3, participants should be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China"],"whoShouldSkip":["History of any clinically important disease or disorder","History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs","Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention","Any clinically important abnormalities in laboratory values, clinical chemistry, hematology, urinalysis results, or vital signs","History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity to drugs of a similar class to AZD1043","Has received prescription, non-prescription, or experimental medications for weight loss within 3 months prior to the Screening Visit","History of psychosis or bipolar disorder or major depressive disorder within the past 2 years with the participant being clinically unstable"],"whatHappens":"If you join, the listed intervention(s) are AZD1043, or Placebo. The registry lists allocation as randomized. The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD1043 following single and multiple ascending doses in healthy adult participants living with overweight and/or obesity, including participants of Japanese and Chinese descent.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 104 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.833Z"},{"nctId":"NCT07513376","title":"A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)","officialTitle":"A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.\n\nPeople with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.\n\nThe main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Intismeran"},{"type":"BIOLOGICAL","name":"Pembrolizumab coformulated with berahyaluronidase alfa"},{"type":"OTHER","name":"Placebo"}],"enrollment":876,"startDate":"2026-05-04","completionDate":"2034-08-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \\>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology\n* Has undergone a complete surgical resection of the primary NSCLC\n* Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC\n* Has provided a tissue sample from recent surgery along with the required blood sample\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs\n* Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia\n* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed\n* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease\n* Has active infection requiring systemic therapy other than those permitted in protocol\n* Has history of stem cell/solid organ transplant\n* Participants who have not adequately recovered from major surgery or have ongoing surgical complications","locations":[{"facility":"UC Davis Comprehensive Cancer Center ( Site 3204)","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Cancer Center ( Site 3268)","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Center at Yale-New Haven ( Site 3253)","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UF Health Cancer Center ( Site 3257)","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Cancer Care ( Site 7000)","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine ( Site 3279)","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Billings Clinic ( Site 3255)","city":"Billings","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Revive Research Institute, LLC ( Site 3218)","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)","city":"Reno","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Oncology Hematology, P.C. ( Site 9000)","city":"Albany","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SUNY Upstate Medical University ( Site 3270)","city":"Syracuse","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"White Plains Hospital ( Site 3213)","city":"White Plains","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charles George VA Medical Center ( Site 3233)","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Lineberger Comprehensive Cancer Center ( Site 3250)","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WakeMed Raleigh Campus ( Site 3214)","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Fargo Medical Center ( Site 3236)","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altru Health System ( Site 3254)","city":"Grand Forks","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Perelman Center for Advanced Medicine ( Site 3205)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanford Cancer Center ( Site 3266)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avera Cancer Institute ( Site 3209)","city":"Sioux Falls","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Tennessee Medical Center ( Site 3223)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas-MD Anderson Cancer Center ( Site 3283)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology Oncology Associates of Fredericksburg ( Site 3275)","city":"Fredericksburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Center ( Site 3202)","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University ( Site 3237)","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gundersen Health System ( Site 3200)","city":"La Crosse","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal North Shore Hospital ( Site 0502)","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital ( Site 0503)","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"One Clinical Research ( Site 0501)","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Clínicas de Passo Fundo ( Site 3601)","city":"Pasos Fundo","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Samaritano De Sao Paulo ( Site 3612)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sírio Libanês ( Site 3611)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)","city":"Kingston","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital Cancer Centre ( Site 2508)","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier de l'Université de Montréal ( Site 2501)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica MEDS La Dehesa ( Site 3708)","city":"Lo Barnechea","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro de Oncología de Precisión ( Site 3706)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"FALP-UIDO ( Site 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People with high-risk, localized NSCLC are often treated with surgery.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has undergone a complete surgical resection of the primary NSCLC","Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC","Has provided a tissue sample from recent surgery along with the required blood sample","Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization","Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Intismeran, Pembrolizumab coformulated with berahyaluronidase alfa, or Placebo. The registry lists allocation as randomized. Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 876 people at 126 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.650Z"},{"nctId":"NCT07513662","title":"Headache Education and Awareness vs. Daily Mindfulness Strategies - Understanding Pain","officialTitle":"Feasibility Trial of a Remotely-Delivered Mindfulness-Based Intervention for Adolescents With Migraine","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable:\n\n1. Telehealth group mindfulness-based intervention\n2. Telehealth group headache education","conditions":["Migraine","Migraine in Adolescence"],"keywords":["Adolescent","Mindfulness","Mindfulness Intervention","Migraine","Headache","Headache Education","Randomized controlled trial"],"interventions":[{"type":"BEHAVIORAL","name":"BREATHE with Headache (BREATHE-HA)"},{"type":"BEHAVIORAL","name":"Enhanced Standard-of-Care: Headache Education"}],"enrollment":72,"startDate":"2026-11-10","completionDate":"2028-08","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 12 to 17 years old\n* Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition\n* Patient report of at least 6 headache days per month\n* At least mild headache-related disability, as assessed by PedMIDAS score \\> 10\n* Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment\n* Adolescent participant fluent in English for the intervention content\n\nExclusion Criteria:\n\n* Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months\n* Current psychiatric crisis (e.g., active suicidal ideation)\n* Cognitive impairments or developmental delays that interfere with their ability to participate in the study\n* Inability to provide consent/assent","locations":[{"facility":"Children's Hospital Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michelle A Clementi, Ph.D.","phone":"720-777-7487","email":"michelle.clementi@childrenscolorado.org"},{"name":"Arlet Campuzano, B.S.","phone":"","email":"arlet.campuzano@childrenscolorado.org"}],"primaryOutcomes":["Recruitment Feasibility (Primary)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["aurora-colorado"],"enrichment":{"headline":"Not a traditional drug phase: BREATHE with Headache (BREATHE-HA) for Migraine","inPlainEnglish":"The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable: 1. Telehealth group mindfulness-based intervention 2.","whoItsFor":["Ages 12 Years to 17 Years","Age 12 to 17 years old","Diagnosed with migraine by medical provider using criteria from the International Classification of Headache Disorders, Third Edition","Patient report of at least 6 headache days per month","At least mild headache-related disability, as assessed by PedMIDAS score \\> 10","Stable dose (≥4 weeks) of prophylactic migraine medication or no current prophylactic medication at enrollment","Adolescent participant fluent in English for the intervention content"],"whoShouldSkip":["Currently engaged in, or previously received 4 or more sessions of behavioral interventions for pain management (e.g., mindfulness or cognitive-behavioral therapy) in the past 6 months","Current psychiatric crisis (e.g., active suicidal ideation)","Cognitive impairments or developmental delays that interfere with their ability to participate in the study","Inability to provide consent/assent"],"whatHappens":"If you join, the listed intervention(s) are BREATHE with Headache (BREATHE-HA), or Enhanced Standard-of-Care: Headache Education. The registry lists allocation as randomized. The goal of this study (supported by and included in the NIH HEAL Initiative: https://heal.nih.gov/) is to learn if a fully virtual study comparing two telehealth group interventions for adolescents with migraine is feasible and acceptable: 1.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 72 people at Aurora. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.291Z"},{"nctId":"NCT07516405","title":"Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","officialTitle":"A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.","conditions":["Healthy Volunteer","Older Adults (65-85 Years)"],"keywords":["healthy older adults ages 65-85","psilocybin safety","psilocybin tolerability"],"interventions":[{"type":"DRUG","name":"Psilocybin (Usona Institute)"}],"enrollment":40,"startDate":"2026-04-01","completionDate":"2028-03","sex":"ALL","minAge":"65 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 65-85 years \\& be male, female, or non-binary\n* Generally healthy\n* Have an identified support person\n* Capacity to Consent\n\nExclusion Criteria:\n\n* Unstable medical condition\n* Risk for hypertensive crisis (screening blood pressure \\>140/90 mmHg)\n* Significant central nervous system (CNS) pathology\n* Primary psychotic or affective psychotic disorders\n* Family history of psychotic or serious bipolar spectrum illnesses\n* High risk of adverse emotional or behavioral reaction\n* Active substance use disorders (SUDs)\n* Extensive use of serotonergic hallucinogens\n* High risk of completed suicide\n* History of hallucinogen persisting perception disorder (HPPD)\n* Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10\n* Certain psychiatric conditions\n* Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study","locations":[{"facility":"University of California San Francisco (UCSF) Department of Neurology","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Brain Health Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Langone Health, Center for Psychedelic Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mary P Mancuso, MA (dual degrees)","phone":"3037245729","email":"inspire@cuanschutz.edu"},{"name":"Lila Harris, BS","phone":"","email":"lila.m.harris@cuanschutz.edu"}],"primaryOutcomes":["Adverse Events"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["san-francisco-california","aurora-colorado","atlanta-georgia","boston-massachusetts","omaha-nebraska","new-york-new-york"],"enrichment":{"headline":"Phase 1: testing Psilocybin (Usona Institute) for Healthy Volunteer","inPlainEnglish":"This study plans to learn more about the whether it is safe and how hard side effects are to live with of psychedelic administration (psilocybin) in healthy older adults ages 65-85.","whoItsFor":["Ages 65 Years to 85 Years","Aged 65-85 years \\& be male, female, or non-binary","Have an identified support person","Capacity to Consent"],"whoShouldSkip":["Unstable medical condition","Risk for hypertensive crisis (screening blood pressure \\>140/90 mmHg)","Significant central nervous system (CNS) pathology","Primary psychotic or affective psychotic disorders","Family history of psychotic or serious bipolar spectrum illnesses","High risk of adverse emotional or behavioral reaction","Active substance use disorders (SUDs)"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (Usona Institute). The registry lists allocation as na. This study plans to learn more about the whether it is safe and how hard side effects are to live with of psychedelic administration (psilocybin) in healthy older adults ages 65-85.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 40 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.102Z"},{"nctId":"NCT07516444","title":"VDyne TriNova Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial)","officialTitle":"VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"VDyne, Inc.","sponsorClass":"INDUSTRY","summary":"Pivotal trial to evaluate the safety and clinical efficacy of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.","conditions":["Tricuspid Valve Regurgitation","Tricuspid Valve Disease","Cardiovascular Diseases (CVD)","Heart Valve Diseases","Tricuspid Valve Insufficiency","Severe Heart Valve Disease","Randomized Controlled Trial (RCT)","Symptomatic Tricuspid Regurgitation"],"keywords":["VDyne","TRIVITA","TRIVITA Pivotal","Tricuspid Regurgitation"],"interventions":[{"type":"DEVICE","name":"Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System"},{"type":"DEVICE","name":"Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System"}],"enrollment":520,"startDate":"2026-07-28","completionDate":"2029-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years old\n* Subject is willing and able to comply with all study evaluations and provide consent\n* Subject must agree not to participate in any other clinical trial for a period of one year following index procedure\n* New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory\n* At least severe symptomatic tricuspid regurgitation.\n* Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR\n* Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement\n* Functional and/or degenerative TR graded as at least severe\n\nExclusion Criteria:\n\n* Subject unable or unwilling to comply with study required testing and follow-up visits\n* Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study\n* Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure.\n* Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically\n* Life expectancy ≤12 months due to non-cardiac comorbidities\n* Current IV Drug user (must be free from drug abuse for ≥1 year)\n* Subject unable or unwilling to provide written, informed consent before study enrollment\n* Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System\n* Hypersensitivity to metals (such as nickel or titanium)\n* Prior tricuspid valve surgery or catheter-based therapy with permanent residual device(s) implanted that would preclude delivery or implantation of the VDyne valve (e.g., valve replacement, edge to edge repair, etc.)\n* Severe valvular heart disease using established echocardiographic criteria requiring intervention other than the tricuspid valve\n* Known significant intracardiac shunt (e.g., septal defect).\n* Cerebrovascular accident (stroke, TIA) within 90 days of treatment procedure\n* Severe lung disease (severe COPD) or continuous use of home oxygen or oral steroids\n* Acute myocardial infarction (AMI) within 30 days of SSC determination of eligibility\n* Leukopenia, chronic anemia (Hgb \\< 9 g/dL), current thrombocytopenia (platelets \\<70/mcL), history of bleeding diathesis, or coagulopathy\n* Unwilling to receive blood products\n* Deep vein thrombosis and/or pulmonary embolism in the last 6-months","locations":[{"facility":"Banner Health","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Honor Health","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health/ California Pacific Medical Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Via Christi Hospital","city":"Wichita","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detriot","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis Heart Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christ Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health and Science Unversity","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Medical Center","city":"Murray","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vinny Podichetty","phone":"763-777-5969","email":"vpodichetty@vdyne.com"},{"name":"Jeya Satheesh","phone":"952-686-8158","email":"jsatheesh@vdyne.com"}],"primaryOutcomes":["Composite of major adverse events (MAEs)","Composite of all-cause mortality, heart failure hospitalization, or non-elective tricuspid valve reintervention","Change in Quality of Life (QOL) as measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)","Change in Quality of Life (QOL) as measured by New York Heart Association (NYHA)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","scottsdale-arizona","san-francisco-california","wichita-kansas","detriot-michigan","minneapolis-minnesota","rochester-minnesota","cincinnati-ohio","portland-oregon","charleston-south-carolina","murray-utah"],"enrichment":{"headline":"Not a traditional drug phase: Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System for Tricuspid Valve Regurgitation","inPlainEnglish":"Pivotal trial to measure the safety and clinical how well it works of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.","whoItsFor":["Ages 18 Years to any","Subject is willing and able to comply with all study evaluations and provide consent","Subject must agree not to participate in any other clinical trial for a period of one year following index procedure","New York Heart Association (NYHA) Functional Class II, III, or IV and ambulatory","At least severe symptomatic tricuspid regurgitation","Despite adequate and Optimized Medical Therapy (OMT), subject has signs and symptoms from TR, or prior heart failure hospitalization from TR","Heart team determines that the subject is appropriate for transcatheter tricuspid valve replacement","Functional and/or degenerative TR graded as at least severe"],"whoShouldSkip":["Subject is currently participating in another clinical trial (drug, biologic, or device) that has not yet completed its primary endpoint or is likely to interfere with this study","Pregnant, lactating subjects, and /or those who plan pregnancy in the period up to one year following index procedure","Known hypersensitivity or contraindication to procedural or post-procedural medications (e.g., contrast solution, anticoagulation, etc.) which cannot be adequately managed medically","Life expectancy ≤12 months due to non-cardiac comorbidities","Current IV Drug user (must be free from drug abuse for ≥1 year)","Tricuspid valve anatomy (cardiac and vascular) that is not suitable for the VDyne System","Hypersensitivity to metals (such as nickel or titanium)"],"whatHappens":"If you join, the listed intervention(s) are Transcatheter Tricuspid Valve Replacement (TTVR) with VDyne TriNova System, or Transcatheter Tricuspid Valve Replacement (TTVR) with Edwards EVOQUE System. The registry lists allocation as randomized. Pivotal trial to measure the safety and clinical how well it works of the VDyne TriNova System for the treatment of symptomatic severe or greater tricuspid regurgitation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 520 people at 12 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.565Z"},{"nctId":"NCT07518914","title":"Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa ( PROTECT-L)","officialTitle":"Protecting Against Lenacapavir Misinformation With Young Women in Gauteng, South Africa","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women. Lenacapavir (LEN), the first long-acting injectable PrEP administered twice yearly, offers a promising alternative that could improve persistence and protection. However, LEN's potential may be undermined by misinformation, particularly around safety and trust, which has been shown in other HIV prevention contexts to reduce uptake and demand. Proactive strategies, such as psychological inoculation, are therefore needed to prebunk misinformation and support future LEN implementation among AGYW.\n\nPrimary objective: To compare changes in intentions to receive Lenacapavir following misinformation exposure in groups with and without psychological inoculation and behavioural economics boost.\n\nSecondary objectives: (1) To compare believability and persuasiveness of misinformation claims and motivational threat associated with misinformation in groups with and without psychological inoculation and behavioural economics boost. (2) To explore subgroup effects by relevant sociodemographic and behavioural factors including HIV risk, PrEP history, COVID-19 vaccine history, general vaccine hesitancy, and information avoidance. The investigators will conduct a two-arm randomized controlled trial of 2-3 inoculation messages that address emerging myths and misinformation about Lenacapavir in South Africa. Participants will be randomly assigned to a control group or an intervention arm: enhanced inoculation message with insights from behavioural economics.","conditions":["Misinformation","Lenacapavir"],"keywords":["South Africa","Lenacapavir","Adolescent Girls and Young WOmen","PrEP"],"interventions":[{"type":"BEHAVIORAL","name":"Diabetes information"},{"type":"BEHAVIORAL","name":"Enhanced inoculation message"}],"enrollment":1500,"startDate":"2026-05-19","completionDate":"2028-04","sex":"FEMALE","minAge":"18 Years","maxAge":"29 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Female (cisgender or transgender)\n* Age 18-29 years\n* Self-reported history of sexual activity in the past 12 months\n* Self-reported HIV-negative status or unknown HIV status at enrolment\n* Willing and able to provide consent\n* Able to read and understand English\n\nExclusion Criteria:\n\nUnwilling or unable to provide consent for study participation.","locations":[{"facility":"Health Economics and Epidemiology Research Office, University of the Witwatersrand","city":"Johannesburg","state":"","country":"South Africa","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Teniola Egbe, MPH, MBE","phone":"215-898-2939","email":"tegbe@pennmedicine.upenn.edu"},{"name":"Alison Buttenheim, PhD","phone":"","email":"butt@nursing.upenn.edu"}],"primaryOutcomes":["Lenacapavir intention, at the end of the baseline assessment"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["johannesburg-south-africa"],"enrichment":{"headline":"Not a traditional drug phase: Diabetes information for Misinformation","inPlainEnglish":"Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP. While oral PrEP is effective, its reliance on daily adherence and regular follow-up has limited impact for many young women.","whoItsFor":["Ages 18 Years to 29 Years","Women only","Female (cisgender or transgender)","Self-reported history of sexual activity in the past 12 months","Self-reported HIV-negative status or unknown HIV status at enrolment","Able to read and understand English"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Diabetes information, or Enhanced inoculation message. The registry lists allocation as randomized. Adolescent girls and young women (AGYW) in South Africa remain disproportionately affected by HIV, with prevalence among 15-24-year-olds at 9.4% in 2024 despite expanded access to condoms, HIV testing, and oral PrEP.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,500 people at Johannesburg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.397Z"},{"nctId":"NCT07519395","title":"A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)","officialTitle":"BALANCE - A Two-part, 26-week, Randomized, Double-Blind, Dose-rAnging, pLAcebo-coNtrolled, Phase 2b Study to Evaluate the effiCacy and safEty of Camlipixant in Adults With IBS-D and IBS-M","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study is designed to evaluate the efficacy and safety of camlipixant in adults with IBS-D and IBS-M. The study has two parts. After the first part, some participants will be randomly chosen again to either get a higher dose or stop the drug.","conditions":["Irritable Bowel Syndrome"],"keywords":["Camlipixant","Irritable bowel syndrome - Mixed","Irritable bowel syndrome - Diarrhea","Dose Ranging"],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Camlipixant"}],"enrollment":420,"startDate":"2026-04-08","completionDate":"2027-03-09","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF).\n* Diagnosis of IBS-D or IBS-M according to the Rome IV V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis\n* Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit\n* Weekly API score \\>=4.0 in each week of the run-in period\n* IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period\n* IBS-M: an average of at least 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\\>)25% of abnormal bowel movements must be Type 6 or 7 and \\>25% Type 1 or 2\n\nExclusion Criteria:\n\n* Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)\n* History or presence of inflammatory or immune-mediated disorders of the small or large intestine e.g. inflammatory bowel disease, microscopic colitis, or celiac disease\n* History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening\n* History or presence of small intestinal bacterial overgrowth within 6 months prior to screening\n* History or presence of bile salt diarrhea\n* History of a primary psychiatric diagnosis that the Investigator considers may interfere with study assessments (e.g., schizophrenia, schizoaffective disorder, major depression, anxiety, panic attacks or bipolar disorder) OR Hospital Anxiety and Depression Scale (HADS) score of \\>10 on either the anxiety or depression sub-scale at screening.\n* Prior use of more than two of the following therapies or classes of therapy for the management of IBS:\n\n  * Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \\[TCAs\\], Selective serotonin reuptake inhibitor \\[SSRIs\\], gabapentinoids)\n  * Antibiotics (e.g., rifaximin, neomycin)\n  * 5-hydroxytryptamine 3 (5-HT3) receptor antagonists (e.g., alosetron, ramosetron, ondansetron)\n  * Mu-opioid receptor agonists (e.g., eluxadoline)\n  * Secretagogues (e.g., linaclotide, lubiprostone, plecanatide, tenapanor)\n  * 5-hydroxytryptamine 4 (5-HT4) receptor agonists (e.g., tegaserod)\n* Abnormal thyroid function tests less than (\\<) Lower limit of normal (LLN) or greater than (\\>) upper limit of normal (ULN) confirmed at screening with Thyroid stimulating hormone (TSH)\n* Positive celiac serology\n* Elevated fecal calprotectin levels\n* QT interval corrected using Fridericia's formula (QTcF) \\>450 millisecond (msec) or QTcF \\>480 msec for participants with bundle branch block using the Fridericia's corrected QT interval (performed during Run-in period considered as screening ECG).\n* Clinically significant abnormal laboratory tests at screening, after one repeat laboratory test if allowed by the Medical Monitor, including the following:\n\n  * Alanine aminotransferase (ALT) \\>2\\*ULN\n  * Total Bilirubin \\>1.5\\*ULN\n  * Aspartate aminotransferase (AST) \\>2\\*ULN\n* Current or chronic history of liver disease (Child-Pugh class A, B, or C) or biliary abnormalities (with the exception of asymptomatic gallstones). Participants with known or suspected Gilbert's Syndrome are not permissible.","locations":[{"facility":"GSK Investigational Site","city":"Anniston","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Guntersville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Saraland","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tempe","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Lancaster","state":"California","country":"United 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Site","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Brandon","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Doral","state":"Florida","country":"United 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2: testing Placebo for Irritable Bowel Syndrome","inPlainEnglish":"This study is designed to measure the how well it works and safety of camlipixant in adults with IBS-D and IBS-M. After the first part, some you would be randomly chosen again to either get a higher dose or stop the drug.","whoItsFor":["Ages 18 Years to 80 Years","Diagnosis of IBS-D or IBS-M according to the Rome IV V criteria at screening with documented IBS symptoms onset at least 6 months prior to the diagnosis","Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Scoring System (IBS SSS) at screening visit","Weekly API score \\>=4.0 in each week of the run-in period","IBS-D: at least one stool with BSFS Type 6 or 7 consistency on at least 2 days in each week of the run-in period","IBS-M: an average of at least 2 days per week with abnormal bowel movements (BSFS Type 1, 2, 6, or 7) during the run-in period, and greater than (\\>)25% of abnormal bowel movements must be Type 6 or 7 and \\>25% Type 1 or 2"],"whoShouldSkip":["Diagnosis of Irritable bowel syndrome - constipation (IBS-C) or Irritable bowel syndrome - unclassified (IBS-U)","History or presence of inflammatory or immune-mediated disorders of the small or large intestine e.g. inflammatory bowel disease, microscopic colitis, or celiac disease","History or presence of GI infection (confirmed with stool culture) within 3 months prior to screening","History or presence of small intestinal bacterial overgrowth within 6 months prior to screening","History or presence of bile salt diarrhea","Prior use of more than two of the following therapies or classes of therapy for the management of IBS:","Antidepressants or neuromodulators (e.g., Tricyclic antidepressant \\[TCAs\\], Selective serotonin reuptake inhibitor \\[SSRIs\\], gabapentinoids)"],"whatHappens":"If you join, the listed intervention(s) are Placebo, or Camlipixant. The registry lists allocation as randomized. This study is designed to measure the how well it works and safety of camlipixant in adults with IBS-D and IBS-M.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 420 people at 94 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.438Z"},{"nctId":"NCT07519655","title":"Phase 1 Study of PF-08046033 in Advanced Solid Tumors","officialTitle":"A Phase 1 Study to Investigate PF-08046033 in Participants With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.\n\nThe study includes adult participants who have advanced cancers that cannot be removed by surgery or have spread to other parts of the body. These cancers include non-small cell lung cancer, esophageal squamous cell cancer, and melanoma.\n\nThe study has two parts:\n\nIn the first part, small groups of participants receive increasing doses of the study medicine. This helps researchers find a dose that is safe and suitable for further testing.\n\nOnce a suitable dose is identified, the second part enrolls more participants with specific cancer types to better understand the safety of the medicine and whether it shows signs of helping control the cancer.\n\nParticipants receive the study medicine through regular treatment cycles and are closely monitored for side effects and how their cancer responds. The information from this study will help researchers decide whether PF-08046033 should be studied further in later-stage clinical trials.","conditions":["Non-Small-Cell Lung","Esophageal Cancer","Cutaneous Melanoma"],"keywords":["Lung cancer","Esophageal cancer","Melanoma","Antibody drug conjugate"],"interventions":[{"type":"DRUG","name":"PF-08046033"}],"enrollment":250,"startDate":"2026-04-08","completionDate":"2028-07-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma.\n2. Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2).\n3. Participants must have measurable disease.\n4. Eastern Cooperative Oncology Group (ECOG) performance status is 0-1.\n\nExclusion Criteria:\n\n1. Participants with known clinically active central nervous system (CNS) metastases.\n2. Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0.\n3. Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%.\n4. Untreated clinically significant thromboembolic disease.\n5. Previous exposure to GPNMB-targeted therapy.\n6. Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention.","locations":[{"facility":"Presbyterian/St Lukes Medical Center","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute at HealthONE","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Yale New Haven Health","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale - New Haven Hospital - Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Phase 1 Unit","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital - Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute- Pharmacy","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Infusion Pharmacy","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncopole Claudius Regaud","city":"Toulouse","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Oncologico Dr. Isaac Gonzalez-Martinez","city":"Rio Piedras","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pan American Center for Oncology Trials, LLC","city":"Rio Piedras","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul-teukbyeolsi [seoul]","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"Barcelona [barcelona]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Fundación Jiménez Díaz","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Type, incidence and severity of participants with adverse events (AEs)","Type, incidence, and severity of participants with laboratory abnormalities","Number of participants with dose modifications","Incidence of dose-limiting toxicities (DLTs)","Recommended dose and schedule of PF-08046033 for expansion (RDE)"],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma","als"],"drugSlugs":[],"locationSlugs":["denver-colorado","new-haven-connecticut","trumbull-connecticut","nashville-tennessee","fairfax-virginia","toulouse-france","villejuif-france","amsterdam-netherlands","rio-piedras-puerto-rico","seoul-south-korea","barcelona-spain","madrid-spain"],"enrichment":{"headline":"Phase 1: testing PF-08046033 for Non-Small-Cell Lung","inPlainEnglish":"This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033. The goal of the study is to understand how safe the medicine is, how well people tolerate it, how it behaves in the body, and whether it shows early signs of helping to treat cancer.","whoItsFor":["Ages 18 Years to any","Participants must have histologically-confirmed metastatic or unresectable locally advanced NSCLC, ESCC, or cutaneous melanoma","Participants must have disease that has progressed on or be unable to tolerate standard treatments (Part 1) or 1-2 prior systemic therapies (Part 2)","Participants must have measurable disease","Eastern Cooperative Oncology Group (ECOG) performance status is 0-1"],"whoShouldSkip":["Participants with known clinically active central nervous system (CNS) metastases","Participants with pre-existing neuropathy ≥Grade 2 per NCI CTCAE v 5.0","Uncontrolled diabetes mellitus with hemoglobin (Hgb) A1C ≥10.0%","Untreated clinically significant thromboembolic disease","Previous exposure to GPNMB-targeted therapy","Known or suspected hypersensitivity to any component or excipient contained in the drug formulation of study intervention"],"whatHappens":"If you join, the listed intervention(s) are PF-08046033. The registry lists allocation as randomized. This is an early-stage (Phase 1) clinical study testing a new study medicine called PF-08046033.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 250 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.806Z"},{"nctId":"NCT07519772","title":"A Clinical Study of MK-1045 in People With Non-Hodgkin Lymphoma (MK-1045-008)","officialTitle":"A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK-1045 Monotherapy or in Combination With Other Anticancer Agents in Participants With Non-Hodgkin Lymphoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). FL is a slow-growing type of NHL. DLBCL is a fast-growing type of NHL. NHL is a cancer in the lymphatic system that causes swollen lymph nodes. The lymphatic system is part of the immune system.\n\nIn this study, researchers want to learn if MK-1045 can treat FL and DLBCL. MK-1045 is a study treatment that is an immunotherapy, which helps the immune system fight cancer.\n\nThe goals of this study are to learn how safe MK-1045 is and if people tolerate it. Researchers also want to see if FL and DLBCL respond (the cancer gets smaller or goes away) to treatment.","conditions":["Lymphoma, Non-Hodgkin","Lymphoma, Follicular","Lymphoma, Large B-Cell, Diffuse"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-1045"}],"enrollment":280,"startDate":"2026-05-03","completionDate":"2030-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.\n* Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).\n* DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.\n* Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).\n* Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.\n* Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.\n* Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.\n* Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.\n* Has radiographically measurable disease per Lugano Response Criteria.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has received a solid organ transplant.\n* Had or has clinically relevant central nervous system (CNS) diseases.\n* Has a history of serious cardiovascular or cerebrovascular diseases.\n* Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.\n* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has received a live or live-attenuated vaccine within 30 days of randomization.\n* Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.\n* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.\n* Has known active CNS lymphoma or involvement.\n* Has active autoimmune disease that required systemic treatment in the past 2 years.\n* Has active infection requiring systemic therapy.\n* Has a history of severe bleeding disorders.\n* Has not recovered from major surgery or has ongoing surgical complications.\n* Has diagnosis of primary mediastinal B-cell lymphoma.","locations":[{"facility":"Cedar Sinai Cancer Center ( Site 0119)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Blood Cancer Institute ( Site 7000)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Cleveland ( Site 0113)","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 0100)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry-Joyce Cancer Clinic ( Site 0115)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 1404)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Austral ( Site 1402)","city":"Pilar","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Nuestra Senora del Rosario ( Site 1403)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Aleman ( Site 1400)","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Townsville University Hospital ( Site 0204)","city":"Townsville","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital ( Site 0205)","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Box Hill Hospital ( Site 0202)","city":"Box Hill","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Erasto Gaertner ( Site 1503)","city":"Curitiba","state":"Paraná","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clinicas FMUSP ( Site 1502)","city":"São Paulo","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Paulistano ( Site 1504)","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre ( Site 0301)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0305)","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Alemana de Santiago ( Site 1608)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Catolica de Chile-CICUC ( Site 1603)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital ( Site 1701)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Provincial Cancer Hospital.. ( Site 1704)","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center ( Site 1712)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henan Cancer Hospital ( Site 1702)","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center ( Site 1711)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Saint Louis ( Site 0405)","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"UKGM Gießen/Marburg ( Site 0505)","city":"Giessen","state":"Hesse","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitatsklinikum Essen AoR ( Site 0507)","city":"Essen","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carmel Hospital ( Site 0602)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center ( Site 0603)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haddasah Medical Center ( Site 0600)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0601)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center. ( Site 0604)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Nazionale Tumori IRCCS Fondazione Pascale-SC Ematologia Oncologica ( Site 0700)","city":"Campania","state":"Napoli","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"INOC - Istituto Nazionale Oncologico Candiolo ( Site 0701)","city":"Candiolo","state":"Piedmont","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Europeo di Oncologia IRCCS ( Site 0702)","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli ( Site 0705)","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia MCM Krakow ( Site 0903)","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Chłonnego ( Site 0900)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)","city":"Gliwice","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia Onkologia Katowice ( Site 0902)","city":"Katowice","state":"Silesian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 0800)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, Yeouido St. Mary's Hospital ( Site 0801)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia (ICO) - Badalona ( Site 1103)","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Virgen de la Victoria ( Site 1104)","city":"Málaga","state":"Malaga","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall de Hebron ( Site 1102)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Gregorio Maranon ( Site 1101)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre ( Site 1105)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1000)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Antalya Egitim ve Arastirma Hastanesi ( Site 1003)","city":"Antalya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Koç Üniversitesi Hastanesi ( Site 1001)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medipol Mega Universite Hastanesi ( Site 1002)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsun Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi ( Site 1005)","city":"Samsun","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Derriford Hospital ( Site 1304)","city":"Plymouth","state":"Devon","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation Trust ( Site 1300)","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Number of Participants Who Experience an Adverse Event (AE)","Number of Participants Who Discontinue Study Treatment Due to an AE","Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)","Arms 1, 2, and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","denver-colorado","cleveland-ohio","nashville-tennessee","ciudad-autonoma-de-buenos-aires-argentina","pilar-argentina","rosario-argentina","caba-argentina","townsville-australia","adelaide-australia","box-hill-australia","curitiba-brazil","s-o-paulo-brazil","toronto-canada","montreal-canada","santiago-chile","beijing-china","fuzhou-china","guangzhou-china","zhengzhou-china","shanghai-china","paris-france","giessen-germany","essen-germany","haifa-israel","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","campania-italy","candiolo-italy","milan-italy","roma-italy","krakow-poland","warsaw-poland","gliwice-poland","katowice-poland","seoul-south-korea","badalona-spain","m-laga-spain","barcelona-spain","madrid-spain","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","istanbul-turkey-t-rkiye","samsun-turkey-t-rkiye","plymouth-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing MK-1045 for Lymphoma, Non-Hodgkin","inPlainEnglish":"Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL). NHL is a cancer in the lymphatic system that causes swollen lymph nodes.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy","Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)","DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy","Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care)","Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy","Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-1045. The registry lists allocation as randomized. Researchers are looking for new ways to treat 2 types of non-Hodgkin lymphoma (NHL) called follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 280 people at 54 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.150Z"},{"nctId":"NCT07520045","title":"Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab","officialTitle":"A Comparative Analysis of OCT and OCT Angiography Biomarkers and Systemic Laboratory Parameters in Patients With Diabetic Retinopathy Undergoing Treatment With Faricimab or Biosimilar Ranibizumab Following Three Loading Doses","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Osijek University Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are:\n\nWhich OCT and OCT angiography biomarkers predict early treatment response? How do imaging biomarkers change after three loading doses of treatment? Are imaging biomarkers associated with systemic laboratory parameters? Researchers will compare faricimab to biosimilar ranibizumab to see if there are differences in imaging biomarkers and early treatment response.\n\nParticipants will:\n\n* be randomized in a 1:1 ratio using a computer-generated randomization sequence\n* undergo comprehensive ophthalmic examinations, including visual acuity and intraocular pressure measurement\n* undergo OCT and OCT angiography imaging at each visit\n* receive three intravitreal injections during the loading phase\n* attend follow-up visits from baseline to 4-5 weeks after the third injection\n* provide blood samples for systemic laboratory analysis","conditions":["Diabetic Retinopathy (DR)","Diabetic Macular Edema (DME)"],"keywords":["Diabetic Retinopathy","ranibizumab","faricimab","biomarkers","OCT"],"interventions":[{"type":"DRUG","name":"Faricimab"},{"type":"DRUG","name":"Biosimilar ranibizumab"}],"enrollment":100,"startDate":"2026-03-12","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Diabetic retinopathy with or without central macular edema\n* Indication for intravitreal anti-VEGF therapy according to current clinical guidelines\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment\n* Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment\n* Retinal laser photocoagulation in the study eye within 3 months prior to enrollment\n* Presence of other ocular, retinal or macular diseases that may affect OCT/OCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)\n* Retinal detachment, preretinal fibrosis, vitreomacular traction\n* Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT/OCTA imaging\n* Uncontrolled glaucoma (intraocular pressure \\> 30 mmHg in study eye)\n* Active ocular inflammation\n* Suspected active ocular infection in either eye\n* Any febrile illness within 1 week prior to first injection\n* History or presence of any clinically significant disease, non-diabetic metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the opinion of the investigator, may contraindicate treatment with faricimab or biosimilar ranibizumab, interfere with the interpretation of study results, or place the participant at increased risk of treatment-related complications.\n* Women who are pregnant, breastfeeding, or planning pregnancy within the next 100 weeks\n* Known hypersensitivity to faricimab or biosimilar ranibizumab or any of its excipients\n* Participation in another clinical trial that may affect study outcomes\n* Inability to comply with study procedures or follow-up","locations":[{"facility":"University Hospital Osijek","city":"Osijek","state":"","country":"Croatia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ivanka Maduna, MD","phone":"+385981962588","email":"ivankamadun@gmail.com"},{"name":"Andrijana Kopić, MD, PhD","phone":"+385981776750","email":"andrijanakopic@gmail.com"}],"primaryOutcomes":["Comparison of OCT and OCTA biomarkers associated with early anatomical treatment response to faricimab and biosimilar ranibizumab"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["faricimab"],"locationSlugs":["osijek-croatia"],"enrichment":{"headline":"Not a traditional drug phase: testing Faricimab for Diabetic Retinopathy (DR)","inPlainEnglish":"The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies. The main questions it aims to answer are: Which OCT and OCT angiography biomarkers predict early treatment response?","whoItsFor":["Ages 18 Years to any","Adults aged ≥18 years","Diabetic retinopathy with or without central macular edema","Indication for intravitreal anti-VEGF therapy according to current clinical guidelines"],"whoShouldSkip":["Intravitreal anti-VEGF or corticosteroid treatment in the study eye within 5 months prior to enrollment","Any intraocular surgery (including cataract surgery) 3 months prior intraocular surgery to enrollment","Retinal laser photocoagulation in the study eye within 3 months prior to enrollment","Presence of other ocular, retinal or macular diseases that may affect OCT/OCTA findings or visual acuity (e.g., age-related macular degeneration, retinal vascular occlusions)","Retinal detachment, preretinal fibrosis, vitreomacular traction","Significant media opacities (e.g., dense cataract, vitreous hemorrhage) precluding reliable OCT/OCTA imaging","Uncontrolled glaucoma (intraocular pressure \\> 30 mmHg in study eye)"],"whatHappens":"If you join, the listed intervention(s) are Faricimab, or Biosimilar ranibizumab. The registry lists allocation as randomized. The goal of this clinical trial is to see if treatment with faricimab or biosimilar ranibizumab leads to different early imaging changes in adults with diabetic retinopathy requiring anti-VEGF treatment and to identify OCT and OCTA biomarkers predictive of differential early treatment response between the two therapies.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Osijek. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.133Z"},{"nctId":"NCT07520162","title":"A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab","officialTitle":"BIFANG: A Multicentre, Single-Arm, Phase 3b Study to Assess Nasal Polyps Score and Symptoms in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.","conditions":["Chronic Rhinosinusitis With Nasal Polyps"],"keywords":["CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)"],"interventions":[{"type":"DRUG","name":"Tezepelumab"}],"enrollment":230,"startDate":"2026-04-24","completionDate":"2028-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age\n\n  1\\. Participant must be 18 years of age or older, at the time of signing the informed consent.\n* Type of Participant and Disease Characteristics 2. Participants who are with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:\n* Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader\n* Mean NCS ≥ 2 in the 2 weeks prior to Visit 2\n* Ongoing documented NP symptoms for \\> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep\n* SNOT-22 total score ≥ 30 as assessed at screening. 3. Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also ensure that participants are compliant and on a stable dose of the background INCS during study period.\n\n  4\\. Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance or intolerance to surgery) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance or intolerance to surgery).\n\n  5\\. Participants with JESREC score of ≥ 11.\n* Weight 6. Body weight of ≥ 40 kg at Visit 1.\n* Sex and Contraceptive/Barrier Requirements 7. Male and/or female\n\nFemale participants:\n\n* Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non-childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.\n* Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first tezepelumab administration without an alternative medical cause.\n* The following age-specific requirements apply:\n\n  * Women \\< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels within the postmenopausal range.\n  * Women \\> 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.\n* WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:\n\n  * Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal\n  * Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable\n  * Intrauterine device\n  * Intrauterine hormone-releasing system\n  * Bilateral tubal occlusion\n  * Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)\n  * Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.\n  * Cessation of contraception after this point should be discussed with a responsible physician.\n* Informed Consent 8. Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n-Medical Conditions\n\n1. Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.\n2. Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.\n3. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:\n\n   * Affect the safety of the participant throughout the study\n   * Influence the findings of the study or the interpretation\n   * Impede the participant's ability to complete the entire duration of study\n4. Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.\n5. Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:\n\n   * Antrochoanal polyps\n   * Nasal septal deviation that occludes at least one nostril\n   * Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome\n6. History of cancer:\n\n   * Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1\n   * Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1\n7. Uncontrolled epistaxis within 2 months of Visit 1.\n8. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.\n9. For participants with comorbid asthma: Current smokers or participants with a smoking history \\> 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \\< 10 packs per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.\n10. History of chronic alcohol or drug abuse within 12 months prior to Visit 1.\n11. Tuberculosis requiring treatment within the 12 months prior to Visit 1. Particpiants who in the opinion of the investigator have evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. Evaluation will be according to the local standard of care as determined by local guidelines and may consist of medical history and physical examinations, chest x-ray, sputum stain and/or culture, and/or TB test (eg, purified protein derivative or QuantiFeron test).\n12. Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.\n13. History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.\n14. Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.\n\n    -Prior/Concomitant Therapy\n15. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.\n16. Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.\n17. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.\n18. Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study including the follow-up period.\n19. Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.\n20. History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.\n21. Regular use of decongestants (topical or systemic) from Visit 1 onward is not allowed unless used for endoscopic procedure.\n22. Use of corticosteroid-eluting intranasal stents within 6 months prior to Visit 1 and during the study period.\n23. Recent aspirin desensitisation within 6 months of enrolment.\n\n    -Prior/Concurrent Clinical Study Experience\n24. Concurrent enrolment in another clinical study involving a study intervention.\n\n    -Diagnostic Assessments\n25. Any clinically meaningful abnormal finding in physical examination, haematology, or clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.\n26. Evidence of active liver disease, including jaundice or AST, ALT, or ALP \\> 2 times ULN at Visit 1.\n27. Positive hepatitis B surface antigen, or hepatitis C antibody serology at screening, or a positive medical history for hepatitis B or C. Participants with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.\n\n    -Other Exclusions\n28. Participants with JESREC score of \\<11\n29. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site), or participants employed by or relatives of the relatives of the employees of the site or sponsor.\n30. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.\n31. For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancy test must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the tezepelumab, a participant may be enrolled on the basis of a negative urine pregnancy test, though serum β-HCG must still be obtained. If either test is positive, the participant should be excluded. Since urine and serum tests may miss a pregnancy in the first days after conception, relevant menstrual history and sexual history, including methods of contraception, should be considered. Any participant whose menstrual and/or sexual history suggests the possibility of early pregnancy should be excluded.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bengbu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Foshan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guiyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huaian","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kunming","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lanzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ningbo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Qingdao","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taizhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ürümqi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zibo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["To describe changes from baseline in nasal polyp score (NPS)","To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["tezepelumab"],"locationSlugs":["beijing-china","bengbu-china","cangzhou-china","changsha-china","chengdu-china","chongqing-china","foshan-china","fuzhou-china","guangzhou-china","guiyang-china","huaian-china","kunming-china","lanzhou-china","nanchang-china","ningbo-china","qingdao-china","shenyang-china","shenzhen-china","shijiazhuang-china","taiyuan-china","taizhou-china","tianjin-china","r-mqi-china","wuhan-china","wuhu-china","xian-china","yangzhou-china","zibo-china"],"enrichment":{"headline":"Phase 3: testing Tezepelumab for Chronic Rhinosinusitis With Nasal Polyps","inPlainEnglish":"This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.","whoItsFor":["Ages 18 Years to any","Type of Participant and Disease Characteristics 2. Participants who are with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:","Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader","Mean NCS ≥ 2 in the 2 weeks prior to Visit 2","Ongoing documented NP symptoms for \\> 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep","5\\. Participants with JESREC score of ≥ 11","Weight 6. Body weight of ≥ 40 kg at Visit 1","Sex and Contraceptive/Barrier Requirements 7. Male and/or female"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease","Affect the safety of the participant throughout the study","Influence the findings of the study or the interpretation","Impede the participant's ability to complete the entire duration of study","Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible","Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab. The registry lists allocation as na. This is a multicentre, open-label, single-arm, Phase 3b study to assess nasal polyps score and symptoms in Chinese adult participants with chronic rhinosinusitis with nasal polyposis initiating treatment with tezepelumab.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 230 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.860Z"},{"nctId":"NCT07520461","title":"Microbiome-targeted Diet Therapy in Ulcerative Colitis","officialTitle":"Microbiome-targeted Diet Therapy in Ulcerative Colitis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Minnesota","sponsorClass":"OTHER","summary":"The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.","conditions":["Ulcerative Colitis"],"keywords":[],"interventions":[{"type":"OTHER","name":"High Protein, High Fiber (HPHF) Diet"}],"enrollment":40,"startDate":"2026-11-04","completionDate":"2029-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability and willingness to provide informed consent\n* Age at least 18 years old\n* Diagnosis of UC based on clinical and endoscopic criteria\n* UC duration of at least 3 months\n* Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization\n* On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below).\n\n  1. ≥4 weeks if no medication, 5-ASA\n  2. ≥8 wk for immunomodulatory therapy\n  3. ≥12 wk for biologics\n* Ability to comply with study requirements in the opinion of the primary investigator\n\nExclusion Criteria:\n\n* Moderate or severe UC as defined by UCEIS ≥5\n* History of stomach surgery or bowel resection\n* Antibiotic use within 3 months\n* Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)\n* Pregnancy or breastfeeding\n* History of anaphylactic food allergies\n* Intolerance of high dietary fiber content\n* Ongoing alcohol or drug abuse\n* Habitual vegan diet pattern\n* Insufficient freezer space to accommodate meal delivery","locations":[{"facility":"University Of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lulu Chen","phone":"612-301-8294","email":"chen8124@umn.edu"}],"primaryOutcomes":["Fecal H2S Production"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["minneapolis-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: High Protein, High Fiber (HPHF) Diet for Ulcerative Colitis","inPlainEnglish":"The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.","whoItsFor":["Ages 18 Years to any","Age at least 18 years old","Diagnosis of UC based on clinical and endoscopic criteria","UC duration of at least 3 months","Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score ≤4 within 90 days of randomization","On a stable dose or no existing UC therapies (apart from steroids) for defined periods (as outlined below)","≥4 weeks if no medication, 5-ASA","≥8 wk for immunomodulatory therapy"],"whoShouldSkip":["Moderate or severe UC as defined by UCEIS ≥5","History of stomach surgery or bowel resection","Antibiotic use within 3 months","Anticipated antibiotic exposure during the study period (e.g. perioperative antibiotics)","Pregnancy or breastfeeding","History of anaphylactic food allergies","Intolerance of high dietary fiber content"],"whatHappens":"If you join, the listed intervention(s) are High Protein, High Fiber (HPHF) Diet. The registry lists allocation as na. The central objective of this proposal is to test a novel diet capable of meeting the elevated protein requirements in ulcerative colitis (UC), while simultaneously decreasing microbial hydrogen sulfide (H2S) production in the colon with fiber.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Minneapolis. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.202Z"},{"nctId":"NCT07521319","title":"Wearable Voice-Guided BBTi for Comorbid Insomnia and Sleep Apnea (COMISA)","officialTitle":"Wearable Voice-Guided Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea (COMISA): Effects on Insomnia Severity and CPAP Adherence From Mechanism Evaluation and Device Development to a Multicenter Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"National Sun Yat-sen University","sponsorClass":"OTHER","summary":"This study investigates the efficacy of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomized controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants. Primary outcomes include insomnia severity (ISI), daytime sleepiness (ESS), and CPAP adherence. The study aims to establish an evidence-based digital health intervention for improving sleep outcomes in COMISA patients.","conditions":["Comorbid Insomnia and Sleep Apnea","Insomnia","Obstructive Sleep Apnea"],"keywords":["BBTi","COMISA","CPAP","Wearable Device","Sleep"],"interventions":[{"type":"BEHAVIORAL","name":"Brief Behavioral Therapy for Insomnia (BBTi)"},{"type":"DEVICE","name":"Smart Eye-Mask with Voice-Guided Modules"}],"enrollment":361,"startDate":"2026-08-01","completionDate":"2030-07-31","sex":"ALL","minAge":"20 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥20 years.\n* Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events/hour.\n* Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15.\n* Able to understand study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment,\n* Major psychiatric disorder,\n* Severe chronic illness (e.g., severe heart failure or receiving hemodialysis).\n* Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders).\n* Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months.\n* Pregnant or breastfeeding.","locations":[{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"Taiwan","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yen-Chin Chen","phone":"0963412677","email":"yenchin2427@gmail.com"}],"primaryOutcomes":["Change in Insomnia Severity Index (ISI)_T0","Change in Insomnia Severity Index (ISI)_T1","Change in Insomnia Severity Index (ISI)_T2","Change in Insomnia Severity Index (ISI)_T3","Change in Arousal Predisposition Scale (APS)_T0","Change in Arousal Predisposition Scale (APS)_T1","Change in Arousal Predisposition Scale (APS)_T2","Change in Arousal Predisposition Scale (APS)_T3","Change in Pre-Sleep Arousal Scale (PSAS)_T0","Change in Pre-Sleep Arousal Scale (PSAS)_T1","Change in Pre-Sleep Arousal Scale (PSAS)_T2","Change in Pre-Sleep Arousal Scale (PSAS)_T3","Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T0","Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T1","Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T2","Change in Cognitive Emotion Regulation Questionnaire (CERQ)_T3","Change in subjective sleep diary_T0","Change in subjective sleep diary_T1","Change in subjective sleep diary_T2","Change in subjective sleep parameter_T3","Change in Epworth Sleepiness Scale (ESS)_T0","Change in Epworth Sleepiness Scale (ESS)_T1","Change in Epworth Sleepiness Scale (ESS)_T2","Change in Epworth Sleepiness Scale (ESS)_T3","Change in objective sleep parameter(total sleep time)_T0","Change in objective sleep parameter(total sleep time)_T1","Change in objective sleep parameter(total sleep time)_T2","Change in objective sleep parameter(total sleep time)_T3","Change in objective sleep parameter(sleep latency)_T0","Change in objective sleep parameter(sleep latency)_T1","Change in objective sleep parameter(sleep latency)_T2","Change in objective sleep parameter(sleep latency)_T3","Change in objective sleep parameter(number of awakenings)_T0","Change in objective sleep parameter(number of awakenings)_T1","Change in objective sleep parameter(number of awakenings)_T2","Change in objective sleep parameter(number of awakenings)_T3","Change in objective sleep parameter(sleep efficiency)_T0","Change in objective sleep parameter(sleep efficiency)_T1","Change in objective sleep parameter(sleep efficiency)_T2","Change in objective sleep parameter(sleep efficiency)_T3","CPAP Adherence_T0","CPAP Adherence_T1","CPAP Adherence_T2","CPAP Adherence_T3"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["tainan-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: Brief Behavioral Therapy for Insomnia (BBTi) for Comorbid Insomnia and Sleep Apnea","inPlainEnglish":"This study investigates the how well it works of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA). The four-year study comprises three phases: (1) exploration of cognitive-emotion regulation-arousal system mechanisms in COMISA and pilot BBTi intervention testing, (2) development and usability testing of an integrated smart eye-mask with BBTi voice-guided modules, and (3) a multi-center randomly assigned controlled trial (RCT) evaluating the combined BBTi plus smart eye-mask intervention versus BBTi alone, smart eye-mask alone, and standard sleep hygiene education in 160 COMISA participants.","whoItsFor":["Ages 20 Years to 80 Years","Obstructive sleep apnea (OSA) diagnosed by clinical polysomnography (PSG), defined as apnea-hypopnea index (AHI) ≥5 events/hour","Insomnia disorder diagnosed by a physician according to DSM-5 criteria, with Insomnia Severity Index (ISI) score ≥15"],"whoShouldSkip":["Severe cognitive impairment,","Major psychiatric disorder,","Severe chronic illness (e.g., severe heart failure or receiving hemodialysis)","Other sleep disorders (e.g., restless legs syndrome, narcolepsy, circadian rhythm sleep-wake disorders)","Receipt of CBT-I, BBTi, or other behavioral sleep interventions within the past 3 months","Pregnant or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Brief Behavioral Therapy for Insomnia (BBTi), or Smart Eye-Mask with Voice-Guided Modules. The registry lists allocation as randomized. This study investigates the how well it works of a wearable voice-guided Brief Behavioral Therapy for Insomnia (BBTi) combined with a smart eye-mask device for individuals with Comorbid Insomnia and Sleep Apnea (COMISA).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 361 people at Tainan. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.950Z"},{"nctId":"NCT07521930","title":"Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)","officialTitle":"Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.","conditions":["Tetraplegia/Tetraparesis","Amyotrophic Lateral Sclerosis (ALS)","Muscular Disorders, Atrophic","Brain Stem Stroke","Spinal Cord Injuries (SCI)","Muscular Dystrophies","Muscular Atrophy, Progressive","Pontine Hemorrhage","Pontine Infarction"],"keywords":["Assistive device","Brain Computer Interface"],"interventions":[{"type":"DEVICE","name":"INTENT Neural Interface System"}],"enrollment":5,"startDate":"2027-01","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be combined with severe motor-related speech impairment (dysarthria or anarthria), as in Locked In Syndrome (LIS) and amyotrophic lateral sclerosis (ALS), including the bulbar variant of ALS.\n* Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\\*, traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular dystrophy and motor neuron disease, including amyotrophic lateral sclerosis (ALS). \\*Brain stem stroke is defined as an acute onset of neurological deficit with clinical features of brain stem or cerebellar dysfunction lasting more than 24 hours together with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of ischemic infarction or parenchymal hemorrhage.\n* Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.\n* Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities. Candidate must also have less than antigravity strength (\\< 3) throughout the lower limbs.\n* Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\\<3) throughout the upper limbs.\n* Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury\n* Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants\n* Ability to communicate reliably, such as through speech or eye movement\n* Stable psychosocial support system with caregiver capable of monitoring participant throughout the study\n* Ability and willingness to travel to study location up to five days per week for the duration of the study\n* Ability to understand and comply with study session instructions\n* Corrected visual acuity sufficient for use of computer monitor\n\nExclusion Criteria:\n\n* Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.\n* Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).\n* Contraindications to MRI or anticipated need for an MRI during the study period\n* Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)\n* Chronic anti-coagulation and medical contraindication to temporary suspension for surgery\n* Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)\n* Participants with dental caries and a significant risk of dental or periodontal infection\n* Chronic oral or intravenous use of steroids or immunosuppressive therapy\n* Active cancer within the past year or ongoing chemotherapy\n* Uncontrolled autonomic dysreflexia within the past 3 months\n* Hydrocephalus with or without an implanted ventricular shunt\n* Other chronic, unstable medical conditions that could interfere with subject participation.\n* Persistent suicidal ideation within the past 12 months.\n* History of substance use disorder within the past year\n* Pregnancy (confirmation through blood test)\n* Nursing an infant, planning to become pregnant, or not using adequate birth control","locations":[{"facility":"Johns Hopkins Medicine","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nathan E Crone, MD","phone":"4109559441","email":"ncrone@jhmi.edu"},{"name":"Francesco Tenore, PhD","phone":"4437789774","email":"francesco.tenore@jhuapl.edu"}],"primaryOutcomes":["Incidence of Device-Related Adverse Events [Safety and Tolerability]"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: INTENT Neural Interface System for Tetraplegia/Tetraparesis","inPlainEnglish":"The goal of this clinical trial is to measure the safety and preliminary how well it works of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.","whoItsFor":["Ages 18 Years to 80 Years","Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher","Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\\<3) throughout the upper limbs","Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury","Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants","Ability to communicate reliably, such as through speech or eye movement","Stable psychosocial support system with caregiver capable of monitoring participant throughout the study","Ability and willingness to travel to study location up to five days per week for the duration of the study"],"whoShouldSkip":["Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI)","Contraindications to MRI or anticipated need for an MRI during the study period","Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)","Chronic anti-coagulation and medical contraindication to temporary suspension for surgery","Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)","Participants with dental caries and a significant risk of dental or periodontal infection","Chronic oral or intravenous use of steroids or immunosuppressive therapy"],"whatHappens":"If you join, the listed intervention(s) are INTENT Neural Interface System. The registry lists allocation as na. The goal of this clinical trial is to measure the safety and preliminary how well it works of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 5 people at Baltimore. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.610Z"},{"nctId":"NCT07522528","title":"Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study","officialTitle":"Biologics and Paediatric Enteral Nutrition in Crohn's Disease Study (BIOPIC-Kids): Combining Enteral Nutrition With Biologics to Optimise Induction and Maintenance Therapy for Children With Active Crohn's Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Glasgow","sponsorClass":"OTHER","summary":"Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes. However, treatment with biologics is only successful in approximately 55-60%. The liquid-only diet also has a better safety and effectiveness profile than traditional treatments like steroids. However, gut inflammation often returns not long after the normal diet is re-introduced, and it is difficult for patients to stick to as their sole source of nutrition for 6-8 weeks.\n\nThe BIOPIC-Kids study aims to investigate whether replacing the normal diet with specialised milkshakes for 6 weeks improves response to treatment and maintenance of remission with biologics in children and young adults with CD. To achieve this, children and young adults (aged 6-18 years) with active CD commencing biologics as standard of care treatment will be randomly allocated to follow their normal diet OR replace varying amounts of their normal diet with specialised milkshakes for 6 weeks. Participants not wanting to be randomised can choose the group of their preference. Patients starting a liquid-only diet OR biologics alongside a liquid-only diet as standard of care treatment will also be recruited to compare different treatment outcomes.","conditions":["Crohn's Disease (CD)"],"keywords":["Crohn's Disease","Partial Enteral Nutrition","Exclusive Enteral Nutrition","Biologic Therapy","Infliximab","Adalimumab","Combination Therapy","Paediatric"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"enteral nutrition"}],"enrollment":90,"startDate":"2026-03-27","completionDate":"2030-08","sex":"ALL","minAge":"6 Years","maxAge":"18 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Eligible participants to the RCT are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg/kg and who have a clinical indication to initiate standard of care induction treatment with TNFα inhibitors (infliximab or adalimumab).\n* Eligible participants to the observational cohorts are children or young adults (aged 6 to 18 years old) who have active CD (defined as a weighted paediatric Crohn's disease Activity Index score (wPCDAI) ≥ 12.5 or a Faecal Calprotectin level \\>250 mg/kg and who are due to initiate standard of care induction treatment with EEN therapy alongside TNFα inhibitors (infliximab or adalimumab) or standard of care induction treatment with EEN therapy without TNFα inhibitors (infliximab or adalimumab)\n\nExclusion Criteria:\n\n* Inability to provide consent to participate in the study (i.e., this applies to young adults (aged 16-18 years) who are old enough but unable to provide consent and carers (of children aged 6-15 years old) who are unable to provide consent on behalf of their child).\n* Presence of stoma or of short bowel syndrome.\n* Patients currently receiving oral or intravenous steroids at a dosage \\>20mg/day prednisolone or \\>9mg/day budesonide.\n* Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks.\n* CD with a major fistulising or symptomatic fibrotic stricturing phenotype.\n* Patients with comorbid anorexia nervosa.\n* Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition.\n* Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C.\n* Patients with untreated tuberculosis (latent or active).\n* Current enrolment in other studies of an investigational product or dietary intervention.\n* Food allergies, which do not permit participation in the study (e.g., cow's milk allergy).\n* Pregnant and/or breastfeeding individuals.","locations":[{"facility":"The Royal Aberdeen Children's Hospital","city":"Aberdeen","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Crosshouse","city":"Crosshouse","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ninewells Hospital","city":"Dundee","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Royal Hospital for Children & Young People","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Hospital For Children","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Wishaw","city":"Wishaw","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Konstantinos Gerasimidis, Professor","phone":"+441419560580","email":"Konstantinos.Gerasimidis@glasgow.ac.uk"},{"name":"Sophie F Morris, BSc (Hons)","phone":"+447887804802","email":"s.morris.2@research.gla.ac.uk"}],"primaryOutcomes":["Faecal Calprotectin"],"hasResults":false,"conditionSlugs":["als","crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["aberdeen-united-kingdom","crosshouse-united-kingdom","dundee-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","wishaw-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: enteral nutrition for Crohn's Disease (CD)","inPlainEnglish":"Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation. Two important treatments currently used to manage CD are special drug injections (biologics) or a liquid-only diet using specialised milkshakes.","whoItsFor":["Ages 6 Years to 18 Years"],"whoShouldSkip":["Presence of stoma or of short bowel syndrome","Patients currently receiving oral or intravenous steroids at a dosage \\>20mg/day prednisolone or \\>9mg/day budesonide","Patients who start another induction therapy (e.g., high dosage of steroids) or change the dose of background immunomodulator (azathioprine, mercaptopurine, methotrexate) within the past 4 weeks","CD with a major fistulising or symptomatic fibrotic stricturing phenotype","Patients with comorbid anorexia nervosa","Any clinical contraindication to use of exclusive enteral nutrition or partial enteral nutrition","Patients tested positive for blood-borne viruses such as HIV and Hepatitis B and C"],"whatHappens":"If you join, the listed intervention(s) are enteral nutrition. The registry lists allocation as randomized. Crohn's disease (CD) is a chronic, incurable condition associated with gut inflammation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.273Z"},{"nctId":"NCT07523750","title":"A Study of VARIPULSE Pulsed Field Ablation (PFA) Catheter and FARAWAVE PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation","officialTitle":"Comparison of Safety and Effectiveness of a VARIPULSE™ PFA Catheter to FARAWAVE™ PFA Catheter in the Treatment of Participants With Persistent Atrial Fibrillation: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Biosense Webster, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"VARIPULSE Catheter"},{"type":"DEVICE","name":"FARAWAVE Catheter"}],"enrollment":566,"startDate":"2026-04-02","completionDate":"2028-05-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days and less than 365 days in duration documented by: i. A physician's note documenting diagnosis of symptomatic PsAF as defined above and ii. Two electrocardiograms showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than \\[\\>\\] 365 days prior to enrollment) or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirements\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has severe dilatation of the LA (LAD \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \\[\\<\\] 40%) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including TIA) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute MI within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical/percutaneous procedure (for example, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]/beat, regurgitant fraction \\>= 50 percent \\[%\\], and/or effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetra.) and/or a double-coiled implantable cardioverter-defibrillators (ICD), (this exclusion does not include coronary stents, implanted pacemakers, single-coiled ICD and implantable loop recorders \\[ILR\\])\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter)\n* Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy less than 365 days\n\nFor magnetic resonance imaging (MRI) subset:\n\n* Contraindication to use of contrast agents for MRI such as advanced renal disease etcetera\n* Presence of iron-containing metal fragments in the body that renders the participant contraindicated for an MRI\n* Unresolved pre-existing neurological deficit","locations":[{"facility":"Arrhythmia Research Group","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OC Medical Center","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Memorial Hospital","city":"Ventura","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Vincents Medical Center","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Florida Mercy Hospital","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NCH Healthcare","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Saint Joseph's Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Health University Medical Center","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Health Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beth Israel Deaconess Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Trinity Health Michigan Heart - Ann Arbor Campus","city":"Ypsilanti","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Robert Wood Johnson Medical School","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lenox Hill Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester General Hospital","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WakeMed Hospital","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Cardiac Arrhythmia Research Foundation","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor Research Institute","city":"Plano","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Medical Center","city":"Murray","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jesal Parekh","phone":"1 858 2108727","email":"jparekh@its.jnj.com"},{"name":"Josiah M Gillespie","phone":"14059240777","email":"jgille12@its.jnj.com"}],"primaryOutcomes":["Occurrence of Early Onset Primary Adverse Events (PAEs)","Time to Occurrence of Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["jonesboro-arkansas","fountain-valley-california","ventura-california","jacksonville-florida","miami-florida","naples-florida","atlanta-georgia","savannah-georgia","lexington-kentucky","boston-massachusetts","ypsilanti-michigan","new-brunswick-new-jersey","new-york-new-york","rochester-new-york","the-bronx-new-york","raleigh-north-carolina","austin-texas","plano-texas","murray-utah"],"enrichment":{"headline":"Not a traditional drug phase: VARIPULSE Catheter for Atrial Fibrillation","inPlainEnglish":"This study wants to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).","whoItsFor":["Ages 18 Years to 80 Years"],"whoShouldSkip":["Participant has continuous AF \\> 365 days (longstanding persistent AF)","Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)","Participant has had previous surgical or catheter ablation for AF","Participant has severe dilatation of the LA (LAD \\> 50 millimeters \\[mm\\]) of the antero-posterior diameter confirmed by imaging performed within 180 days prior to enrollment","Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure","Participant has severely compromised Left Ventricular Ejection Fraction (LVEF less than \\[\\<\\] 40%) confirmed by imaging performed within 180 days prior to enrollment","Participant has uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV"],"whatHappens":"If you join, the listed intervention(s) are VARIPULSE Catheter, or FARAWAVE Catheter. The registry lists allocation as randomized. This study wants to assess how safe VARIPULSE pulsed field ablation (PFA) catheter is and how well it works compared to food and drug administration (FDA) approved FARAWAVE PFA catheter in participants with symptomatic persistent atrial fibrillation (PsAF; continuous irregular, rapid heartbeat that lasts over 7 days and doesn't stop on its own).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 566 people at 20 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.746Z"},{"nctId":"NCT07524140","title":"A First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","officialTitle":"A Phase 1, First-in-Human Study of ZE94-0605 in Patients With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Eilean Therapeutics","sponsorClass":"INDUSTRY","summary":"ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors. Phase 1a will use sequential dose escalation to determine the maximally tolerated dose and biologically effective dose. Phase 1b will randomize participants with CCNE1 amplification between two dose levels to select the recommended Phase 2 dose.","conditions":["Advanced Solid Tumor Cancer","Metastatic Solid Tumor"],"keywords":["ZE94-0605","Selective CDK2 inhibitor","CCNE1 amplification","Cyclin E1","First-in-human","Dose escalation","Dose optimization","Recommended Phase 2 dose","Project Optimus","Brain-penetrant CDK2 inhibitor","Glioblastoma","RANO 2.0"],"interventions":[{"type":"DRUG","name":"ZE94-0605"}],"enrollment":60,"startDate":"2026-06-25","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nPhase 1a Dose-Escalation Cohorts:\n\n1. Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, and with measurable disease.\n\n   Phase 1b Dose-Expansion Cohorts:\n2. Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, or who has declined such therapy, with CCNE1 amplification and measurable disease.\n\n   Common Inclusion Criteria:\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Adequate end-organ function: creatinine clearance \\>60 mL/min; AST and ALT \\<3 × upper limit of normal (ULN); and total bilirubin \\<1.5 × ULN, except for participants with Gilbert's disease.\n5. Absolute neutrophil count ≥1.5 × 10\\^9/L and platelets ≥100 × 10\\^9/L.\n6. Female participants of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended contraceptive method from signing informed consent through treatment and for 90 days after the last study-drug dose.\n7. Male participants of childbearing potential having intercourse with females of childbearing potential must be willing to abstain from heterosexual intercourse or use a protocol-recommended contraceptive method from signing informed consent through treatment and for 90 days after the last study-drug dose. Male participants must refrain from sperm donation for the same period.\n8. Willingness to comply with scheduled visits, drug administration, imaging, laboratory tests, other study procedures, and restrictions.\n\nExclusion Criteria\n\n1. History of another malignancy, except adequately treated localized basal-cell or squamous-cell skin cancer, cervical carcinoma in situ, superficial bladder cancer, asymptomatic prostate cancer without known metastatic disease, or another cancer in complete remission without treatment for ≥2 years, or one with an anticipated 24-month life expectancy that does not require treatment confounding study assessments. Such cases must be discussed with the Sponsor Medical Monitor before screening for enrollment.\n2. Known active hepatitis C, hepatitis B, or HIV infection.\n3. Pregnancy or breastfeeding.\n4. Concurrent participation in an investigational-drug trial with therapeutic intent or receipt of an investigational agent within 14 days or five half-lives (whichever is longer) before the first study dose; if half-life is unknown, a minimum 14-day washout is required. An investigational agent is one without an approved indication from the U.S. FDA.\n5. Inability to tolerate oral medication, including symptomatic gastrointestinal disease significantly affecting gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel.\n6. Current use of or anticipated need for a medication or therapy prohibited under protocol Section 7.6.2 during the applicable prohibited period, including proton pump inhibitors, prohibited strong CYP3A4 inducers, and prohibited concomitant anticancer treatments; relevant use of strong CYP3A4 inhibitors requires protocol-directed review.\n7. Psychological, familial, social, or geographic factors, another significant medical condition, or laboratory abnormalities that preclude informed consent or adherence, hamper compliance with treatment/follow-up, or confound interpretation.\n8. Uncontrolled intercurrent illness, including symptomatic congestive heart failure, unstable angina, serious cardiac arrhythmia, New York Heart Association Class III/IV heart failure, severe uncontrolled ventricular arrhythmia, or ECG evidence of acute ischemia or active conduction-system abnormality; or comorbidities that preclude safety evaluation of ZE94-0605.\n9. QT interval corrected by Fridericia (QTcF) ≥470 ms unless the participant has a pacemaker. Participants with incomplete or complete bundle branch block may participate following cardiology clearance. A pacemaker does not automatically exclude participation, but device and lead compatibility and institutional MRI safety clearance are required when MRI is necessary. If required MRI cannot be safely performed, the participant is ineligible unless the Sponsor Medical Monitor approves an alternative imaging method acceptable for central response assessment.\n\nNote: This text is faithfully condensed for a public registry; original criterion numbering differs. The protocol places the newly prohibited medication reconciliation instruction at the end of exclusion criterion 9; keep this in investigator instructions rather than individual eligibility criteria, unless preferred by sponsor.\n\nNote: Especially material changes: contraceptive window for women 90 days (older entry used 30 days); washout changed to longer of 14 days or 5 half-lives; PPI exclusion; newly explicit MRI/pacemaker safeguards.","locations":[{"facility":"St. George Private hospital","city":"Kogarah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"SOCRU - Southern Oncology Clinical Research Unit","city":"Bedford Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology Uzbekistan","city":"Tashkent","state":"","country":"Uzbekistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ekaterina Dokukina","phone":"+1 858 353 4108","email":"kdokukina@eilenther.com"}],"primaryOutcomes":["Number of Participants With Dose-Limiting Toxicities","Maximally Tolerated Dose of ZE94-0605","Recommended Phase 2 Dose of ZE94-0605"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["kogarah-australia","bedford-park-australia","tashkent-uzbekistan"],"enrichment":{"headline":"Phase 1: testing ZE94-0605 for Advanced Solid Tumor Cancer","inPlainEnglish":"ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor. This multicenter, open-label, first-in-human Phase 1 study will evaluate ZE94-0605 in adults with advanced, unresectable or metastatic solid tumors.","whoItsFor":["Ages 18 Years to any","Phase 1a Dose-Escalation Cohorts:","Age ≥18 years, with a pathologically confirmed, advanced, unresectable or metastatic solid tumor refractory to, or intolerant of, available therapies known to provide clinical benefit for the participant's condition, if available, and with measurable disease","Phase 1b Dose-Expansion Cohorts:","Common who can join:","Eastern Cooperative Oncology Group (ECOG) performance status 0-1","Adequate end-organ function: creatinine clearance \\>60 mL/min; AST and ALT \\<3 × upper limit of normal (ULN); and total bilirubin \\<1.5 × ULN, except for participants with Gilbert's disease","Absolute neutrophil count ≥1.5 × 10\\^9/L and platelets ≥100 × 10\\^9/L"],"whoShouldSkip":["Known active hepatitis C, hepatitis B, or HIV infection","Pregnancy or breastfeeding","Inability to tolerate oral medication, including symptomatic gastrointestinal disease significantly affecting gastrointestinal function, such as inflammatory bowel disease or resection of the stomach or small bowel","Note: Especially material changes: contraceptive window for women 90 days (older entry used 30 days); washout changed to longer of 14 days or 5 half-lives; PPI exclusion; newly explicit MRI/pacemaker safeguards"],"whatHappens":"If you join, the listed intervention(s) are ZE94-0605. The registry lists allocation as randomized. ZE94-0605 is an oral, selective cyclin-dependent kinase 2 (CDK2) inhibitor.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.473Z"},{"nctId":"NCT07524322","title":"Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors","officialTitle":"A Phase 1/1b Open-Label, Multicenter, First-in-Human Study Evaluating Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of RGT-490 as a Single Agent in Adult Subjects With Locally Advanced or Metastatic PIK3CA-Mutated Solid Tumors Including HR+/HER2- Breast Cancers","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Regor Pharmaceuticals Inc.","sponsorClass":"INDUSTRY","summary":"This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.\n\nParticipants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.","conditions":["Breast Cancer","Ovarian Cancer","Endometrial Cancer","PIK3CA Mutation","HER2- Negative Breast Cancer","Advanced Breast Cancer","Unresectable Solid Tumor","Hormone Receptor Positive Tumor","Cervical Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"RGT-490"}],"enrollment":63,"startDate":"2026-07-21","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy.\n* Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood.\n* At least 1 measurable lesion or evaluable disease per RECIST v1.1.\n* An ECOG performance status of 0 or 1.\n* Adequate organ function\n\nExclusion Criteria:\n\n* Diabetes mellitus requiring anti-hyperglycemic medication.\n* Prior treatment with PI3Kα inhibitors\n* Symptomatic, untreated, or uncontrolled central nervous system metastases.\n* Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment.\n* Unresolved clinically significant toxicities from prior anticancer therapy\n* History of a another malignancy within 2 years prior to screening (exception adequately treated cancers).","locations":[{"facility":"START Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Wheeler","phone":"857-331-3898","email":"Sarah.Wheeler@regor.com"},{"name":"Regor Pharmaceuticals Central Office","phone":"617-315-9070","email":"RGT-490-101@regor.com"}],"primaryOutcomes":["Incidence of dose limiting toxicities (DLTs)","Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer","cervical-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","pittsburgh-pennsylvania","houston-texas","san-antonio-texas","fairfax-virginia"],"enrichment":{"headline":"Phase 1: testing RGT-490 for Breast Cancer","inPlainEnglish":"This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to measure the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer. Participants enrolled in the study have advanced disease that is not amendable to curative treatment and whose tumors harbor alterations in the PI3KCA gene.","whoItsFor":["Ages 18 Years to any","Adults with metastatic or locally advanced, unresectable solid tumors that have progressed on or after at least one available therapy","Presence of one or more documented activating PIK3CA mutation in tumor tissue and/or blood","At least 1 measurable lesion or evaluable disease per RECIST v1.1","An how well you can do daily activities (ECOG score) of 0 or 1","Adequate organ function"],"whoShouldSkip":["Diabetes mellitus requiring anti-hyperglycemic medication","Prior treatment with PI3Kα inhibitors","Symptomatic, untreated, or uncontrolled central nervous system metastases","Receipt of any local or systemic anticancer therapy or investigational anticancer agent within a protocol-defined washout period prior to study treatment","Unresolved clinically significant toxicities from prior anticancer therapy","History of a another malignancy within 2 years prior to screening (exception adequately treated cancers)"],"whatHappens":"If you join, the listed intervention(s) are RGT-490. The registry lists allocation as randomized. This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to measure the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors including breast cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 63 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.702Z"},{"nctId":"NCT07525271","title":"Trial Phase: Syndemic Adapted Medly Uganda","officialTitle":"An mHealth Implementation Strategy to Address the Syndemic of Mental Illness, Hypertension, and HIV in Uganda, Clinical Trial: Syndemic Adapted Medly Uganda (SAMU)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD). PLHIV who experience depression are less likely to link to HIV care, adhere to antiretroviral therapy, and achieve viral suppression. Building on research conducted to adapt Medly Uganda for mental health using a syndemic framework, this study aims to assess the effectiveness of SAMU on mental health screening and diagnosis. This will be accomplished through a two-arm trial in which 1. participants will be enrolled, screened, re-screened, and assessed for diagnosis and linkage to care for depression, anxiety and AUD and 2. evaluate the factors impacting sustained engagement in the SAMU program, through mixed methods.","conditions":["Mental Health"],"keywords":["Depression","Anxiety","HIV","Alcohol Use Disorder","hypertension"],"interventions":[{"type":"DEVICE","name":"Syndemic-Adapted Medly Uganda (SAMU)"}],"enrollment":1500,"startDate":"2026-09-14","completionDate":"2028-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient at a participating HIV clinic site\n* Currently living in Uganda with no intention of moving abroad in next 2 years\n* Access to a mobile phone\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant.\n\nExclusion Criteria:\n\n* No access to a mobile phone\n* Inability to provide informed consent based on assessment by the onsite Research Assistant or HCW\n\nHealthcare Workers/Caregivers Criteria:\n\n* Age \\>=18 years\n* Healthcare worker at participating site or caregiver for study participant at site\n* Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant","locations":[{"facility":"Kawaala Hospital","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Naguru Hospital","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nsambya Hospital","city":"Kampala","state":"","country":"Uganda","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeremy Schwartz, MD","phone":"203-530-7261","email":"jeremy.schwartz@yale.edu"},{"name":"Sarah Christie, PhD, MPH","phone":"475-439-4660","email":"sarah.christie@yale.edu"}],"primaryOutcomes":["Number of participants diagnosed"],"hasResults":false,"conditionSlugs":["depression","hypertension","hiv"],"drugSlugs":[],"locationSlugs":["kampala-uganda"],"enrichment":{"headline":"Not a traditional drug phase: Syndemic-Adapted Medly Uganda (SAMU) for Mental Health","inPlainEnglish":"This study wants to measure the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda. In sub-Saharan Africa (SSA), there is a high prevalence of depression and anxiety among people living with HIV (PLHIV) as well as alcohol use disorder (AUD).","whoItsFor":["Ages 18 Years to any","Patient at a participating HIV clinic site","Currently living in Uganda with no intention of moving abroad in next 2 years","Access to a mobile phone","Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant"],"whoShouldSkip":["No access to a mobile phone","Healthcare Workers/Caregivers Criteria:","Healthcare worker at participating site or caregiver for study participant at site","Basic reading skills in one or more of the offered languages (English, Luganda) as determined by the Research Assistant"],"whatHappens":"If you join, the listed intervention(s) are Syndemic-Adapted Medly Uganda (SAMU). The registry lists allocation as randomized. This study wants to measure the effectiveness of the Syndemic-Adapted Medly Uganda (SAMU) in improving mental health care among adults living with HIV and hypertension in Uganda.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,500 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.039Z"},{"nctId":"NCT07527299","title":"A Study of VARIPULSE Catheter in Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein and Superior Vena Cava Isolation","officialTitle":"Assessment of the Safety and Effectiveness of the VARIPULSE™ Catheter System in the Treatment of Participants With Persistent Atrial Fibrillation Undergoing Pulmonary Vein (With or Without Posterior Wall Isolation) and Superior Vena Cava Isolation: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Biosense Webster, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \\[PVI\\] and superior vena cava isolation \\[SVCI\\]), with or without another technique called posterior wall isolation (PWI). Also, to assess how safe it is for participants who are having a catheter ablation procedure and at the same time receiving another procedure called left atrial appendage occlusion (LAAO; to reduce stroke risk). Additionally, to assess how well VARIPULSE catheter system works over a long period of time for treatment of PsAF in participants undergoing catheter ablation for PVI, SVCI and SVCI+PWI.","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"VARIPULSE Catheter System"},{"type":"DEVICE","name":"LAAO Device"}],"enrollment":1070,"startDate":"2026-08-26","completionDate":"2028-11-30","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Participant has been diagnosed with symptomatic persistent atrial fibrillation (PsAF), which is defined as continuous atrial fibrillation (AF) sustained beyond 7 days in duration and less than 365 days in duration, documented by: i. A physician's note documenting diagnosis of symptomatic PsAF, as defined above; and ii. Two electrocardiograms (ECGs) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrocardiograms cannot be greater than (\\>) 365 days prior to enrollment); or iii. A 24-hour arrhythmia monitor documenting continuous AF within the last 365 days\n* Participant is aged 18 - 80 years at the time of informed consent\n* Participant is willing and capable of providing informed consent\n* Participant is able and willing to comply with all pre-, post- and follow-up testing and requirement\n\nLeft atrial appendage occlusion (LAAO) concomitant subset:\n\n\\- Participant is clinically indicated for a LAAO procedure\n\nExclusion criteria:\n\n* Participant has continuous AF \\> 365 days (longstanding persistent AF)\n* Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)\n* Participant has had previous surgical or catheter ablation for AF\n* Participant is known to require ablation outside the left atrium (LA), superior vena cava (SVC), and the cavotricuspid isthmus (CTI) region (for example, atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, ventricular tachycardia and Wolff-Parkinson-White)\n* Participant has LA (left atrial) anteroposterior \\>= 55 millimeter (mm) (by magnetic resonance imaging \\[MRI\\], computed tomography \\[CT\\], or transthoracic echocardiogram \\[TTE\\]), or if LA diameter is not available, non-index volume \\>100 milliliter (mL) confirmed within 365 days prior to enrollment\n* Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure\n* Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \\[LVEF\\] less than \\[\\<\\] 40 percent \\[%\\]) confirmed by imaging performed within 180 days prior to enrollment\n* Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification\n* Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)\n* Participant has had a thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 180 days prior to enrollment\n* Participant has had a percutaneous coronary intervention or acute myocardial infarction (MI) within past 60 days prior to enrollment\n* Participant has had coronary artery bypass grafting (CABG) surgery within the past 180 days prior to enrollment\n* Participant has had valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Participant has unstable angina within past 6 months prior to enrollment\n* Participant has anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 365 days post-procedure\n* Participant has significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Participant has a significant congenital anomaly (for example, atrial septal defects \\[ASDs\\]) including repaired defects or medical problems that in the opinion of the Investigator would preclude enrollment in this study\n* Participant has an existing diagnosis of pulmonary vein stenosis (PVS)\n* Participant has a pre-existing hemi-diaphragmatic paralysis\n* Participant has an acute illness, active systemic infection, or sepsis\n* Participant has an intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Participant has severe mitral regurgitation (Regurgitant volume greater than or equal to \\[\\>=\\] 60 milliliters \\[mL\\]/beat, Regurgitant fraction \\>= 50%, and/or Effective regurgitant orifice area \\>= 0.40 square centimeter \\[cm\\^2\\])\n* Participants with an implanted metal cardiac device that may interfere with the pulsed field energy field are excluded, including but not limited to: -MitraClip, -LAAO devices (for example, WATCHMAN, Amulet), -Double-coiled implantable cardioverter-defibrillators (ICDs). This exclusion does not apply to participants with any of the following devices: -Coronary stents, -Implanted pacemakers, -Single-coiled ICDs, -Implantable loop recorders (ILRs)\n* Participant has a condition that precludes vascular access (such as inferior vena cava \\[IVC\\] filter) - Participant is currently enrolled in an investigational study evaluating another device or drug\n* Participant is pregnant, lactating, or is of child-bearing potential and plans on trying to become pregnant during the course of the clinical investigation\n* Participant has a life expectancy of less than 365 days\n* Participant has contraindications for the devices used in the study, as indicated in the respective instructions for use (IFUs)\n* Participant has contraindications for the ablation of the SVC\n\nLAAO concomitant subset:\n\n* Participant is contraindicated for a LAAO procedure per the instructions of use of the planned LAAO device\n* Participant with prior LAAO procedure (attempted or successful)","locations":[{"facility":"Grandview Medical Center","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pima Heart and Vascular","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arrhythmia Research Group","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pacific Heart Institute Cedars Sinai Medical Center","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aurora Denver Cardiology Associates","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hartford Hospital","city":"Hartford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JFK Medical Center","city":"Atlantis","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Elizabeth Medical Center","city":"Edgewood","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Munson Medical Center","city":"Traverse City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albert Einstein College Of Medicine - Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Heart Hospital","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penn Presbyterian Medical Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Hospital","city":"Janesville","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Narvelle Delabruere","phone":"949-933-1710","email":"NDelabru@its.jnj.com"},{"name":"Josiah M Gillespie","phone":"405-924-0777","email":"jgille12@its.jnj.com"}],"primaryOutcomes":["Number of Participants with Early Onset Primary Adverse Events (PAEs)","Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes"],"hasResults":false,"conditionSlugs":["als","stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","tucson-arizona","jonesboro-arkansas","santa-monica-california","aurora-colorado","hartford-connecticut","atlantis-florida","edgewood-kentucky","traverse-city-michigan","the-bronx-new-york","oklahoma-city-oklahoma","philadelphia-pennsylvania","janesville-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: VARIPULSE Catheter System for Atrial Fibrillation","inPlainEnglish":"This study wants to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease). This includes isolation of pulmonary vein and superior vena cava (heart veins; pulmonary vein isolation \\[PVI\\] and superior vena cava isolation \\[SVCI\\]), with or without another technique called posterior wall isolation (PWI).","whoItsFor":["Ages 18 Years to 80 Years","Left atrial appendage occlusion (LAAO) concomitant subset:","\\- Participant is clinically indicated for a LAAO procedure"],"whoShouldSkip":["Participant has continuous AF \\> 365 days (longstanding persistent AF)","Participant has AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, untreated documented obstructive sleep apnea, acute alcohol toxicity, etc.)","Participant has had previous surgical or catheter ablation for AF","Participant has LA thrombus confirmed by imaging within 48 hours prior to the procedure","Participant has severely compromised left ventricular ejection fraction (left ventricle ejection fraction \\[LVEF\\] less than \\[\\<\\] 40 percent \\[%\\]) confirmed by imaging performed within 180 days prior to enrollment","Participant has uncontrolled heart failure or New York heart association (NYHA) Class III or IV functional classification","Participant has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (for example, heparin)"],"whatHappens":"If you join, the listed intervention(s) are VARIPULSE Catheter System, or LAAO Device. The registry lists allocation as randomized. This study wants to assess how safe VARIPULSE catheter system is for treatment of a heart rhythm disease called persistent atrial fibrillation (PsAF) in participants who are having a catheter ablation procedure (treat heart rhythm disease).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,070 people at 13 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.745Z"},{"nctId":"NCT07527910","title":"A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD","officialTitle":"A Two-Part, Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of ALN-PNP With and Without a GLP1R Agonist in Adults With Homozygous PNPLA3-Related Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein.\n\nThe goal of this study is to understand the effect of ALN-PNP with or without tirzepatide on reducing liver fat.\n\nThe study is looking at:\n\n* How well ALN-PNP with and without tirzepatide works\n* What side effects ALN-PNP might cause\n* How much ALN-PNP is in the blood at different times\n* How the body and the liver change after having ALN-PNP, which can help researchers understand why ALN-PNP works better in some people than others","conditions":["Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)"],"keywords":["Homozygous PNPLA3-Related MASLD","Fatty Liver Disease","Metabolic Dysfunction-Associated Steatohepatitis (MASH)","Non-Alcoholic Fatty Liver Disease (NAFLD)","Nonalcoholic Steatohepatitis (NASH)"],"interventions":[{"type":"DRUG","name":"ALN-PNP"},{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":204,"startDate":"2026-05-22","completionDate":"2030-03-15","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\nPart A and Part B:\n\n1. Homozygous for the PNPLA3 p.I148M genotype\n2. Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3\n3. Has a Body Mass Index (BMI) ≥30 to \\<45 kg/m\\^2 at visit 2\n\nPart A: To be eligible for randomization on study day 1:\n\n1. Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol\n2. On a stable dose of tirzepatide at randomization (≥5 mg weekly)\n\nKey Exclusion Criteria:\n\n1. Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and/or liver biopsy\n2. Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol\n3. Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions\n4. Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol\n\nNOTE: Other protocol-defined inclusion/exclusion criteria apply.","locations":[{"facility":"Arizona Liver Health - Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Liver Research Institute","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Awareness, Inc","city":"Jupiter","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evolution Clinical Trials","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research, Plaza II","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Research Corporation","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Medical Trials","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Research Corporation at The Texas Liver Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Percent change in liver fat","Percent change in liver fat"],"hasResults":false,"conditionSlugs":["als","fatty-liver"],"drugSlugs":["tirzepatide"],"locationSlugs":["tucson-arizona","coronado-california","pasadena-california","jupiter-florida","miami-florida","metairie-louisiana","austin-texas","georgetown-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 2: testing ALN-PNP for Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","inPlainEnglish":"This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease. ALN-PNP reduces the amount of Patatin-like phospholipase domain-containing protein 3 (PNPLA3), a protein that liver cells make, which may help decrease liver fat if there is an abnormal PNPLA3 protein.","whoItsFor":["Ages 18 Years to 75 Years","Homozygous for the PNPLA3 p.I148M genotype","Liver fat by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) ≥15% at visit 3","Has a Body Mass Index (body-mass index (BMI)) ≥30 to \\<45 kg/m\\^2 at visit 2","Part A: To be eligible for randomization on study day 1:","Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3 × Upper Limit of Normal (ULN) as described in the protocol","On a stable dose of tirzepatide at randomization (≥5 mg weekly)"],"whoShouldSkip":["Evidence or diagnosis of portal hypertension or cirrhosis from any cause, including cirrhosis due to MASH, as determined by the investigator, based on medical history, clinical assessment, imaging, and/or liver biopsy","Known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol","Contraindications to MRI examinations, including but not limited to persons with MRI-incompatible cardiac pacemaker and implants made of metal, severe claustrophobia, size restrictions","Any contraindication listed in the Zepbound United States Prescribing Information (USPI), as defined in the protocol","NOTE: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ALN-PNP, Tirzepatide, or Placebo. The registry lists allocation as randomized. This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty liver disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 204 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.164Z"},{"nctId":"NCT07527923","title":"First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis","officialTitle":"A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test an experimental study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.\n\nThe study is looking at:\n\n* What side effects REGN20423 might cause\n* How much REGN20423 is in the blood at different times\n* How well REGN20423 works in adults with atopic dermatitis\n* Whether the body makes antibodies against REGN20423\n* How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others\n* What the best dose of REGN20423 is","conditions":["Healthy Volunteer","Atopic Dermatitis"],"keywords":["Eczema","Inflammatory skin disease"],"interventions":[{"type":"DRUG","name":"REGN20423"},{"type":"OTHER","name":"Placebo"}],"enrollment":160,"startDate":"2026-05-22","completionDate":"2028-08-14","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis\n\nKey Inclusion Criteria:\n\nPart A:\n\n1. Maximum age of 65 years of age (Part A Only)\n2. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention\n3. Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit\n\n   Part B:\n4. Has a history of AD for at least 6 months at screening\n5. Has EASI score ≥5 at both the screening and baseline visits\n6. Has IGA score ≥2 at both the screening and baseline visits\n\nKey Exclusion Criteria\n\nPart A:\n\n1. Hospitalized (\\>24 hours) for any reason within 30 days prior to the screening visit\n2. Hypersensitivity to the study treatment or any of its excipients\n3. History of clinical parasite infection, except treated trichomoniasis\n4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study\n5. History of alcohol or drug abuse as determined by the investigator\n\n   Part B:\n6. Known or suspected history of immunosuppression\n7. Presence of skin comorbidities at screening that may interfere with study assessments\n8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list\n9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study\n\nNote: Other protocol defined Inclusion/ Exclusion criteria apply","locations":[{"facility":"Cahaba Dermatology & Skin Health Center, LLC","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Research Trials","city":"North Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Clinical, Focus Clinical Research","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida International Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research of Weston LLC","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rophe Adult and Pediatric Medicine","city":"Union City","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Allergy and Asthma Research, LLC","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Dermatology and Laser Specialists","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Occurrence of Treatment Emergent Adverse Events (TEAEs)","Severity of TEAEs"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","north-little-rock-arkansas","west-hills-california","miami-florida","weston-florida","union-city-georgia","north-charleston-south-carolina","san-antonio-texas","leuven-belgium"],"enrichment":{"headline":"Phase 1: testing REGN20423 for Healthy Volunteer","inPlainEnglish":"This study will test an experimental study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies.","whoItsFor":["Ages 18 Years to 65 Years","Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis","Maximum age of 65 years of age (Part A Only)","Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention","Has a body-mass index (BMI) within 18 to 31 kg/m² (inclusive) at the screening visit","Has a history of AD for at least 6 months at screening","Has EASI score ≥5 at both the screening and baseline visits","Has IGA score ≥2 at both the screening and baseline visits"],"whoShouldSkip":["Hospitalized (\\>24 hours) for any reason within 30 days prior to the screening visit","Hypersensitivity to the study treatment or any of its excipients","History of clinical parasite infection, except treated trichomoniasis","Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study","History of alcohol or drug abuse as determined by the investigator","Known or suspected history of immunosuppression","Presence of skin comorbidities at screening that may interfere with study assessments"],"whatHappens":"If you join, the listed intervention(s) are REGN20423, or Placebo. The registry lists allocation as randomized. This study will test an experimental study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 160 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.820Z"},{"nctId":"NCT07530757","title":"SuperCAP Program to Improve Cognition and Daily Functioning in Post-COVID-19 Condition","officialTitle":"Randomized Controlled Trial to Assess the Efficacy of a Supervised Computerized Active Program (SuperCAP) to Improve Cognition and Daily Functioning in People With Post-COVID-19 Condition","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia","sponsorClass":"OTHER","summary":"The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.\n\nThe main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.\n\nParticipants assigned to the SuperCAP intervention will undergo a series of sessions that include psychoeducation, adaptive cognitive training exercises, fatigue self-management strategies, and multidisciplinary content.","conditions":["Post COVID Condition"],"keywords":["Post COVID Condition","Long COVID","SuperCAP"],"interventions":[{"type":"DEVICE","name":"SuperCAP intervention program"},{"type":"OTHER","name":"Psychoeducational intervention"}],"enrollment":100,"startDate":"2026-07-15","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases.\n* Age 18 to 65 years.\n* Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC.\n* Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score \\> 6 at baseline via RedCAP.\n* Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP.\n* Self-reported ability to use a mobile application for approximately 15 minutes per day, 5 days per week, considering their current symptoms.\n* Possession of a personal smartphone compatible with the study mobile application (eSalut), with sufficient storage space and operating system version required for installation.\n\nExclusion Criteria:\n\n* Inability to undergo neuropsychological tests or additional assessments.\n* Prior use of the SuperCAP program.\n* Current participation in a trial or program aimed at improving PCC symptoms.\n* Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant's ability to complete the study.","locations":[{"facility":"Fundació Lluita contra les Infeccions - Hospital Universitari Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Prats, PhD","phone":"+34934657897","email":"aprats@lluita.org"},{"name":"David Rovira","phone":"+34934978849","email":"drovira@scienhub.org"}],"primaryOutcomes":["To determine whether the SuperCAP intervention program is superior to control in reducing disability."],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["badalona-spain"],"enrichment":{"headline":"Not a traditional drug phase: SuperCAP intervention program for Post COVID Condition","inPlainEnglish":"The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition. The main question it aims to answer is whether participants assigned to SuperCAP experience a greater reduction in disability, defined as an improvement of at least 5 points on the WHODAS 2.0 from baseline to the post-intervention visit, compared with participants in the control group.","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of PCC, defined as the presence of three or more symptoms associated with COVID-19 infection for at least three months, not explained by other diseases","Age 18 to 65 years","Willingness to participate in an app-based intervention program aimed at improving daily Functioning in People Living with PCC","Evidence of patient-reported cognitive difficulties emerging after COVID-19, operationalized as a WHODAS 2.0 Cognition Domain (D1) score \\> 6 at baseline via RedCAP","Digital proficiency defined as scoring ≥4 on MDPQ-16 item 2a (sending emails) and ≥3 on item 6a (using the device's app store) via RedCAP","Self-reported ability to use a mobile application for approximately 15 minutes per day, 5 days per week, considering their current symptoms","Possession of a personal smartphone compatible with the study mobile application (eSalut), with sufficient storage space and operating system version required for installation"],"whoShouldSkip":["Inability to undergo neuropsychological tests or additional assessments","Prior use of the SuperCAP program","Current participation in a trial or program aimed at improving PCC symptoms","Any condition that, in the investigator's opinion, could make participation unsafe, complicate interpretation of study results, interfere with achievement of study objectives, or otherwise affect the participant's ability to complete the study"],"whatHappens":"If you join, the listed intervention(s) are SuperCAP intervention program, or Psychoeducational intervention. The registry lists allocation as randomized. The goal of this study is to determine whether the SuperCAP intervention program is superior to control in reducing disability from baseline to the post-intervention assessment in people with Post-COVID-19 Condition.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Badalona. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.242Z"},{"nctId":"NCT07531745","title":"ASCEND: Safety and Tolerability of ION337 for the Treatment of Dravet Syndrome","officialTitle":"Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients With Dravet Syndrome","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Ionis Pharmaceuticals, Inc.","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to evaluate the safety and tolerability of ION337 in participants with Dravet syndrome (DS).","conditions":["Dravet Syndrome"],"keywords":["Dravet syndrome"],"interventions":[{"type":"DRUG","name":"ION337"}],"enrollment":32,"startDate":"2026-05-21","completionDate":"2030-12","sex":"ALL","minAge":"2 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participant is aged ≥ 2 to ≤ 12 years old at the time of informed consent.\n2. Participant has at least 1 parent or caregiver ≥ 18 years old who is willing and able to provide informed consent (signed and dated) and attend all scheduled study visits.\n3. Has a documented diagnosis of DS according to the International League Against Epilepsy (ILAE) criteria and as agreed by the Epilepsy Study Consortium, Inc (ESCI).\n4. Has confirmation of a pathogenic or likely pathogenic SCN1A variant.\n5. Must be currently receiving ≥ 1 concomitant ASM at a stable dose/regimen for ≥ 4 weeks prior to informed consent.\n6. Must have all other interventions for epilepsy (including ketogenic diet or VNS) as well as any other concomitant medications including medications for behavioral management, sleep, and supplements or nutritional support stable for ≥ 4 weeks prior to informed consent. Vagus nerve stimulator implantation must have occurred ≥ 6 months prior to informed consent.\n7. Experiences the required number of major motor seizures during the Screening Period.\n\nKey Exclusion Criteria:\n\n1. Known brain or spinal disease that would interfere with the LP procedure or CSF circulation, or presence of other factors that would affect the safety of the LP procedure.\n2. Pathogenic or likely pathogenic variant in another gene that causes epilepsy.\n3. Has had prior treatment with or is currently enrolled in an interventional clinical trial for a gene therapy or for another antisense oligonucleotide (ASO) for the treatment of DS.\n4. Has had treatment with or is currently enrolled in an interventional clinical trial of any other investigational drug, biological agent, or device within 30 days prior to Screening, or 5 half-lives of investigational agent, whichever is longer.\n5. Current treatment with an anti-seizure medication (ASM) acting primarily as a sodium channel blocker, as maintenance treatment.\n6. Prior brain surgeries including: corpus callosotomy, implantation of device for deep brain stimulation or any other palliative brain surgery intended to reduce seizure burden.\n\nNote: Other protocol pre-specified inclusion/exclusion criteria may apply.","locations":[{"facility":"University of Michigan Health System","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke University Health Systems","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Children's Hospital of Philadelphia (CHOP)","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Le Bonheur Children's Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Hospital","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Center - Research Institute","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ionis Pharmaceuticals, Inc.","phone":"(844) 867-4309","email":"IonisDravetSyndrome@clinicaltrialmedia.com"}],"primaryOutcomes":["Parts 1 and 2: Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs","Number of Participants With Clinically Significant Change From Baseline in Safety Laboratory Values","Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Vital Signs","Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG)","Parts 1 and 2: Number of Participants With Clinically Significant Change From Baseline in Physical and Neurological Examination Findings","Parts 1 and 2: Number of Participants with Change in Columbia Suicidality Severity Rating Scale (C-SSRS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan","rochester-minnesota","durham-north-carolina","philadelphia-pennsylvania","memphis-tennessee","seattle-washington","montreal-canada"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ION337 for Dravet Syndrome","inPlainEnglish":"The primary purpose of this study is to measure the whether it is safe and how hard side effects are to live with of ION337 in participants with Dravet syndrome (DS).","whoItsFor":["Ages 2 Years to 12 Years","Has a documented diagnosis of DS according to the International League Against Epilepsy (ILAE) criteria and as agreed by the Epilepsy Study Consortium, Inc (ESCI)","Has confirmation of a pathogenic or likely pathogenic SCN1A variant","Experiences the required number of major motor seizures during the Screening Period"],"whoShouldSkip":["Known brain or spinal disease that would interfere with the LP procedure or CSF circulation, or presence of other factors that would affect the safety of the LP procedure","Pathogenic or likely pathogenic variant in another gene that causes epilepsy","Has had prior treatment with or is currently enrolled in an treatment clinical trial for a gene therapy or for another antisense oligonucleotide (ASO) for the treatment of DS","Has had treatment with or is currently enrolled in an treatment clinical trial of any other investigational drug, biological agent, or device within 30 days prior to Screening, or 5 half-lives of investigational agent, whichever is longer","Current treatment with an anti-seizure medication (ASM) acting primarily as a sodium channel blocker, as maintenance treatment","Prior brain surgeries including: corpus callosotomy, implantation of device for deep brain stimulation or any other palliative brain surgery intended to reduce seizure burden","Note: Other protocol pre-specified inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ION337. The registry lists allocation as randomized. The primary purpose of this study is to measure the whether it is safe and how hard side effects are to live with of ION337 in participants with Dravet syndrome (DS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.909Z"},{"nctId":"NCT07532226","title":"A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants","officialTitle":"A Real-World, Prospective Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Patients","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen-Cilag Ltd.","sponsorClass":"INDUSTRY","summary":"This observational study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).","conditions":["Arthritis, Psoriatic"],"keywords":[],"interventions":[],"enrollment":200,"startDate":"2026-04-17","completionDate":"2029-12-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR)\n* Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the observational study\n* Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication\n* The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations\n* Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements\n\nExclusion Criteria:\n\n* Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment.\n* Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase \\[JAK\\] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time\n* Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis)\n* Unwilling or unable to participate in long-term data collection\n* Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before the start of the study ( that is, signing of informed consent)\n* Currently enrolled in any interventional study or any Janssen-Cilag France-sponsored observational clinical study\n* Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization","locations":[{"facility":"Hopital Roger Salengro - CHU Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Proportion of Participants Still Receiving Treatment at 1 Year","Percentage of Participants Still Receiving Treatment at Persistence Time","Number of Participants Starting New Treatment"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["lille-france"],"enrichment":{"headline":"A Study of Guselkumab Treatment Persistence in Psoriatic Arthritis Participants","inPlainEnglish":"This watch-and-measure (no experimental treatment required) study aims to assess the 1-year persistence of guselkumab in adult patients with psoriatic arthritis (an inflammatory disease that affects the joints in participants with psoriasis, a skin condition that causes red, scaly patches).","whoItsFor":["Ages 18 Years to any","Have a confirmed diagnosis of psoriatic arthritis (PsA) as determined by a rheumatologist with reference to ClASsification criteria for Psoriatic ARthritis (CASPAR)","Start guselkumab as a first, second, third, or fourth line of disease-modifying antirheumatic drug (bDMARD) therapy for the indication of PsA as part of standard clinical practice at the time of enrollment into the watch-and-measure (no experimental treatment required) study","Initiating guselkumab treatment according to Summary of Product Characteristics (SmPC) indication","The treatment decision must be taken by the participating rheumatologist prior to, and independently of the patient's inclusion into the study, following clinical practice in accordance with local and overarching guidelines and local regulations","Must have received the information note, given his/her oral agreement and has not objected to the collection of his/her data in accordance with French requirements"],"whoShouldSkip":["Have already taken a specific interleukin-23 inhibitor (IL-23i) treatment","Are receiving combination therapy: 2 or more targeted therapies (biotherapy, Janus kinase \\[JAK\\] inhibitor, phosphodiesterase 4 (PDE4) inhibitor) indicated for PsA/PsO at the same time","Has a contra-indication to guselkumab according to the SmPC (for hypersensitivity or due to active clinically important infection, example active tuberculosis)","Unwilling or unable to participate in long-term data collection","Currently enrolled in any treatment study or any Janssen-Cilag France-sponsored watch-and-measure (no experimental treatment required) clinical study","Is under guardianship or curatorship, judicial protection, future protection mandate or under family authorization"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Lille. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.577Z"},{"nctId":"NCT07532954","title":"The Impact Of A Patient Support Community On Patients With Neuroendocrine Cervical Cancer: NECC Peer Support","officialTitle":"The Impact Of A Patient Support Community On Patients With Neuroendocrine Cervical Cancer: NECC Peer Support","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To learn about the effects of a participant support community on illness perception, emotional well-being, and feelings of isolation among participants with NECC.","conditions":["Neuroendocrine Cervical Cancer","Patient Support"],"keywords":[],"interventions":[{"type":"OTHER","name":"Questionnaire"}],"enrollment":40,"startDate":"2026-04-13","completionDate":"2028-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Eligibility Criteria\n\n* Histologically confirmed NECC.\n* Aged 18 years or older.\n* English proficient.\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access).\n\nExclusion Criteria None","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Larissa Meyer, MD","phone":"Meyer","email":"lmeyer@mdanderson.org"}],"primaryOutcomes":["Demographic questionnaire"],"hasResults":false,"conditionSlugs":["cervical-cancer"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Questionnaire for Neuroendocrine Cervical Cancer","inPlainEnglish":"To learn about the effects of a participant support community on illness perception, emotional well-being, and feelings of isolation among participants with NECC.","whoItsFor":["Ages 18 Years to any","Eligibility Criteria","Histologically confirmed NECC","Aged 18 years or older","English proficient","Stated willingness to comply with all study procedures and availability for the duration of the study","Access to necessary resources for participating in a technology-based intervention (i.e., computer, smartphone, internet access)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Houston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.326Z"},{"nctId":"NCT07533955","title":"A Phase 1 Study of JADE201 in Participants With Rheumatoid Arthritis","officialTitle":"A Phase 1, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JADE201 Administered Subcutaneously in Participants With Rheumatoid Arthritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Jade Biosciences, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1, first in human study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to placebo in participants with Rheumatoid Arthritis","conditions":["Rhematoid Arthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"JADE201"},{"type":"DRUG","name":"Placebo"}],"enrollment":36,"startDate":"2026-05-19","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male and female participants 18-70 years of age, inclusive.\n2. A body weight between 50-100 kg and a body mass index (BMI) between 18-32 kg/m2 (all inclusive) at screening.\n3. Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria\n4. Willing and able to comply with the inpatient stay at the site, scheduled visits, treatment plans, laboratory tests, and other study procedures specified in the protocol.\n5. Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol.\n\nExclusion Criteria:\n\n1. With the exception of RA, known history of clinically significant disease\n2. Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA\n3. positive serology for Hep A, Hep B, or Hep C virus\n4. Positive, indeterminate, or invalid test of TB\n5. Current tobacco users who smoke \\>5 cigarettes per day or equivalent\n6. Nursing, lactating or pregnant, or who have plans to become pregnant during the study\n7. Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration","locations":[{"facility":"Jade Clinical Site","city":"Sofia","state":"","country":"Bulgaria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Tbilisi","state":"","country":"Georgia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Chisinau","state":"Moldova","country":"Moldova","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Ivano-Frankivsk","state":"Ukraine","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jade Clinical Site","city":"Kyiv","state":"Ukraine","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jade201 Study Contact","phone":"781-201-4781","email":"JADE201clinicaltrials@jadebiosciences.com"}],"primaryOutcomes":["Safety and Tolerability of Single Ascending Doses of JADE201 in participants with Rheumatoid Arthritis"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["sofia-bulgaria","tbilisi-georgia","berlin-germany","chisinau-moldova","bucharest-romania","cluj-napoca-romania","ivano-frankivsk-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 1: testing JADE201 for Rhematoid Arthritis","inPlainEnglish":"This is a Phase 1, first in human study to measure the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to dummy treatment (placebo) in participants with Rheumatoid Arthritis","whoItsFor":["Ages 18 Years to 70 Years","Male and female participants 18-70 years of age, inclusive","A body weight between 50-100 kg and a body mass index (body-mass index (BMI)) between 18-32 kg/m2 (all inclusive) at screening","Confirmed diagnosis of RA according to 2010 ACR/EULAR criteria","Willing and able to comply with the inpatient stay at the site, scheduled visits, treatment plans, laboratory tests, and other study procedures specified in the protocol","Willing and able to comply with contraceptive and lifestyle requirements specified in the protocol"],"whoShouldSkip":["With the exception of RA, known history of clinically significant disease","Diagnosis or symptoms suggestive of any systemic autoimmune or inflammatory condition other than RA","positive serology for Hep A, Hep B, or Hep C virus","Positive, indeterminate, or invalid test of TB","Current tobacco users who smoke \\>5 cigarettes per day or equivalent","Nursing, lactating or pregnant, or who have plans to become pregnant during the study","Treatment with an investigational drug within 30 days or 5 half lives prior to study drug administration"],"whatHappens":"If you join, the listed intervention(s) are JADE201, or Placebo. The registry lists allocation as randomized. This is a Phase 1, first in human study to measure the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of JADE201 compared to dummy treatment (placebo) in participants with Rheumatoid Arthritis","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.961Z"},{"nctId":"NCT07540143","title":"The REACH-OUT Trial","officialTitle":"A Technology-based, Primary Care Strategy to Optimize Blood Pressure Before Pregnancy: The REACH-OUT Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.","conditions":["Hypertension","Reproductive Behavior","Primary Health Care","Electronic Health Record"],"keywords":[],"interventions":[{"type":"OTHER","name":"Health literacy-informed patient education materials"},{"type":"BEHAVIORAL","name":"BP monitor, brief orientation, and portal tools"},{"type":"OTHER","name":"The MeDS assessment"},{"type":"OTHER","name":"Patient navigator support"}],"enrollment":350,"startDate":"2026-06-16","completionDate":"2029-04-01","sex":"FEMALE","minAge":"18 Years","maxAge":"44 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* biologically female\n* age 18-44\n* English or Spanish-speaking\n* prescribed an antiHTN\n* have a systolic BP \\>140 or diastolic BP\\>90 at their index visit\n* have access to the internet\n\nExclusion Criteria:\n\n* not pregnant or within 3 months postpartum\n* severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation","locations":[{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stacy C Bailey, PhD MPH","phone":"(312) 503-3272","email":"stacy-bailey@northwestern.edu"},{"name":"Guisselle Wismer, MPH","phone":"","email":"guisselle.wismer@northwestern.edu"}],"primaryOutcomes":["Systolic blood pressure"],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: Health literacy-informed patient education materials for Hypertension","inPlainEnglish":"Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.","whoItsFor":["Ages 18 Years to 44 Years","Women only","biologically female","English or Spanish-speaking","prescribed an antiHTN","have a systolic BP \\>140 or diastolic BP\\>90 at their index visit","have access to the internet"],"whoShouldSkip":["not pregnant or within 3 months postpartum","severe, uncorrectable vision, hearing, or cognitive impairment that would preclude study consent or participation"],"whatHappens":"If you join, the listed intervention(s) are Health literacy-informed patient education materials, BP monitor, brief orientation, and portal tools, or The MeDS assessment. The registry lists allocation as randomized. Test the effectiveness of a technology-enabled strategy to optimize blood pressure among reproductive-aged women with hypertension receiving care in Federally Qualified Health Centers.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 350 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.036Z"},{"nctId":"NCT07540221","title":"A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","officialTitle":"An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Grifols Therapeutics LLC","sponsorClass":"INDUSTRY","summary":"The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.\n\nParticipants with CIDP will first have up to 28 days of screening to make sure they can join the study. Those who qualify will then start a 19-week treatment period with Gamunex-C. During this period, they will receive Gamunex-C through a vein once every 3 weeks, for a total of 7 doses. Approximately, one week after their last Gamunex-C dose, they will begin a 16-week treatment period with XEMBIFY under the skin, once a week for a total of 16 doses. Blood samples will be collected during both treatment periods to measure IgG level in the blood.","conditions":["CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)"],"keywords":["XEMBIFY","CIDP","IgG","Gamunex-C"],"interventions":[{"type":"BIOLOGICAL","name":"Gamunex-C"},{"type":"BIOLOGICAL","name":"Xembify"}],"enrollment":40,"startDate":"2026-04-02","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP.\n* Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g/kg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive.\n* Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through baseline visit.\n\nExclusion Criteria:\n\n* Diagnosis of polyneuropathy of any other cause (including multifocal motor neuropathy; monoclonal gammopathy of uncertain significance with anti-myelin-associated glycoprotein IgM antibodies; hereditary demyelinating neuropathy; polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes syndrome; lumbosacral radiculoplexus neuropathy; polyneuropathy associated with diabetes mellitus; polyneuropathy associated with systemic illnesses; or drug or toxin induced polyneuropathy).\n* Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the following:\n\n  1. current malignancy or history of allogeneic bone marrow/stem cell transplant,\n  2. cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension\n  3. chronic kidney disease stage IV or V\n  4. an acquired medical condition that is known to cause secondary immune deficiency, such as chronic lymphocytic leukemia, lymphoma, multiple myeloma, chronic or recurrent neutropenia (absolute neutrophil count less than 1000/µL \\[1.0 × 10\\^9/L\\]), or human immunodeficiency virus (HIV) infection/acquired immune deficiency syndrome\n  5. known bleeding disorders\n  6. severe skin disease at the planned injection sites\n  7. alcohol, drug or medication abuse, or\n  8. other disorders where IGSC therapy would be contraindicated during the study.\n* History of a thrombotic episode (including deep vein thrombosis, known hypercoagulable state, myocardial infarction, pulmonary embolism, or thromboembolic stroke)\n* Known allergic or other severe adverse reactions to blood products including intolerability to previous IVIG up to 1 g/kg Q3W, history of hemolysis after IVIG infusion, aseptic meningitis, recurrent severe headache, hypersensitivity, or severe generalized skin reaction\n* Has had a CIDP relapse requiring treatment modification within 12 weeks prior to Screening or between Screening and baseline visit\n* Treatment with any of the following:\n\n  1. alemtuzumab or rituximab within 12 months of Screening.\n  2. cyclophosphamide, interferon, tumor necrosis factor-alpha inhibitors, fingolimod, or fragment crystallizable receptor (FCRn) blockers, within six months of Screening\n  3. plasma exchange or complement inhibitors within three months of Screening.\n  4. changes to the following treatment within three months of Screening: methotrexate, azathioprine, or mycophenolate or any other immunosuppressants within six months of Screening\n  5. participants on corticosteroids ≥ 20 mg/day prednisone equivalent. Participants on low dose corticosteroids (\\< 20 mg/day prednisone equivalent) may be enrolled if dose has been stable over the last three months prior to Screening and the dosage is not likely to be adjusted during the duration of the trial (inhaled or topical corticosteroids are allowed).\n* Participants requiring an IGIV dose equivalent to:\n\n  1. greater than 1.0 g/kg every three weeks (Q3W) or\n  2. less than 0.3 g/kg Q3W or\n  3. greater than 90 g of IGIV Q3W or\n  4. less than 20 g of IGIV Q3W.\n* Known IgA deficient patients with known antibodies against IgA\n* Known significant proteinuria (≥ 3+ or known urinary protein loss \\>1 g/24 hours or nephrotic syndrome), acute renal failure, are on dialysis, and/or have severe renal impairment on Screening laboratory testing (blood urea nitrogen \\[BUN\\] \\> 3 times the upper limit of normal \\[ULN\\] or creatinine more than 1.5 times ULN).\n* Screening values of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels exceeding ≥ 2.5 times the ULN for the expected normal range for the testing laboratory.\n* Hemoglobin levels \\< 10 g/dL at Screening.\n* Current administration of anti-coagulation therapy which would make IGSC administration inadvisable per investigator judgement (i.e., vitamin K antagonists, nonvitamin K antagonist oral anticoagulants \\[e.g., dabigatran etexilate targeting Factor IIa, rivaroxaban, edoxaban, and apixaban targeting Factor Xa\\], and parenteral anticoagulants \\[e.g., fondaparinux\\]).\n* Known hyperviscosity syndrome.\n* Known HIV, chronic hepatitis B virus (HBV), or chronic hepatitis C virus (HCV) infection.\n* Participation in another clinical trial within 30 days or if known, 5 half-lives of the interventional product prior to Screening (observational studies without investigative treatments \\[non-interventional\\] are permitted).","locations":[{"facility":"GC2402 Study Site 104","city":"Rancho Mirage","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 109","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 105","city":"Miami","state":"Florida","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"GC2402 Study Site 103","city":"Port Charlotte","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 110","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 114","city":"Fayetteville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 111","city":"Cordova","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 115","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 106","city":"Sherman","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 401","city":"Hradec Králové","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 206","city":"Bydgoszcz","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 203","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 201","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 205","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 207","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"GC2402 Study Site 302","city":"Târgu Mureş","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Duggan","phone":"+353 87 429 2411","email":"sarah.duggan@grifols.com"},{"name":"Olga Titova","phone":"","email":"olga.titova@grifols.com"}],"primaryOutcomes":["AUC in the IV Phase: Steady-state area under the concentration-time curve (AUC) of total IgG over a 3-week intravenous dosing interval (τ) (i.e., AUC(0-21days) in participants with CIDP","AUC in the SC Phase: Steady-state AUC of total IgG over a weekly SC dosing interval (τ) (i.e., AUC(0-7days)) in participants with CIDP"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["rancho-mirage-california","coral-springs-florida","miami-florida","port-charlotte-florida","new-york-new-york","fayetteville-north-carolina","cordova-tennessee","houston-texas","sherman-texas","hradec-kr-lov-czechia","bydgoszcz-poland","katowice-poland","krakow-poland","wroclaw-poland","t-rgu-mure-romania"],"enrichment":{"headline":"Phase 3: testing Gamunex-C for CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy)","inPlainEnglish":"The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP. Participants with CIDP will first have up to 28 days of screening to make sure they can join the study.","whoItsFor":["Ages 18 Years to any","Have typical CIDP or a CIDP variant according to the 2021 criteria established by the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS). The level of diagnostic certainty may be CIDP or possible CIDP","Participants ≤ 90 kg in body weight and requiring an IGIV dose equivalent to 0.3-1.0 g/kg every three weeks (Q3W) inclusive and between 20-90 g of IGIV Q3W inclusive","Clinically stable on IGIV, defined as no recent change in CIDP treatment or experienced a CIDP relapse requiring treatment, within 12 weeks prior to Screening and through baseline visit"],"whoShouldSkip":["Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study such as the following:","current malignancy or history of allogeneic bone marrow/stem cell transplant,","cardiac insufficiency (New York Heart Association classes III/IV), cardiomyopathy, significant cardiac arrhythmia requiring treatment, unstable or advanced ischemic heart disease, congestive heart failure or severe hypertension","chronic kidney disease stage IV or V","known bleeding disorders","severe skin disease at the planned injection sites","alcohol, drug or medication abuse, or"],"whatHappens":"If you join, the listed intervention(s) are Gamunex-C, or Xembify. The registry lists allocation as randomized. The main goal of the study is to find out whether XEMBIFY, given once a week under the skin, provides similar levels of immunoglobulin G in the blood over time as Gamunex-C, which is given into a vein once every 3 weeks in people with CIDP.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 40 people at 16 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.125Z"},{"nctId":"NCT07540416","title":"Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch","officialTitle":"Tenecteplase Thrombolysis for Acute Ischemic Stroke in the 4.5-9-Hour Window Guided by DWI-FLAIR Mismatch: A Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"The First Affiliated Hospital of Zhengzhou University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the efficacy and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are:\n\n1. Does tenecteplase improve functional outcomes at 90 days compared with standard treatments in AIS patients administered 4.5-9 hours after stroke onset guided by DWI-FLAIR mismatch?\n2. The safety of tenecteplase thrombolysis for AIS patients in the 4.5-9 hours guided by DWI-FLAIR mismatch.\n\nResearchers will compare tenecteplase to placebo to see if it is effective and safe for these patients.\n\nParticipants will be randomly assigned (1:1) immediately after randomization:\n\n* Tenecteplase group: received tenecteplase, intravenously as a bolus administered over a period of 5 to 10 seconds at a dose of 0.25 mg per kilogram (maximum dose, 25 mg), plus aspirin placebo (300 mg).\n* Control group: aspirin (300 mg) plus tenecteplase placebo. From day 2 to day 90, all patients will be conformed to the 2023 Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke.","conditions":["Acute Ischemic Stroke"],"keywords":["Tenecteplase","Thrombolysis","diffusion weighted imaging","fluid attenuated inversion recovery"],"interventions":[{"type":"DRUG","name":"TNK-tPA"},{"type":"DRUG","name":"Aspirin"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Placebo"}],"enrollment":564,"startDate":"2026-11-02","completionDate":"2028-02-29","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);\n3. Imaging criteria:\n\n   1. DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;\n   2. DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;\n4. NIHSS score 4-25;\n5. First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);\n6. Signed informed consent from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Planned endovascular treatment;\n2. Contradictory to MRI examination;\n3. MRI image not qualified for evaluation;\n4. Obvious head injuries or strokes within 3 months;\n5. Subarachnoid or intracranial hemorrhage;\n6. History of intracranial hemorrhage;\n7. Intracranial tumor, arteriovenous malformation or aneurysm;\n8. Intracranial or spinal cord surgery within 3 months;\n9. Active internal hemorrhage;\n10. platelet count of \\<100000/mm3;\n11. Aortic arch dissection;\n12. Heparin therapy within 24 hours;\n13. Oral warfarin is being taken and INR\\>1.6 or APTT abnormal;\n14. Oral anticoagulation therapy;\n15. Systolic pressure≥185 mmHg or diastolic pressure≥110 mmHg;\n16. Blood glucose \\< 50 mg/dl (2.7mmol/L);\n17. Pregnancy;\n18. Neurological deficit after epileptic seizures;\n19. Major surgery within 1 month;\n20. Gastrointestinal or urinary tract hemorrhage within the previous 30 days;\n21. Myocardial infarction within 3 months;\n22. Allergy to study drugs;\n23. Unlikely to adhere to the trial protocol or follow-up;\n24. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study;\n25. Participation in other interventional clinical trials within the previous 3 months.","locations":[{"facility":"The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bo Song, MD","phone":"+86-371-66278068","email":"fccsongb@zzu.edu.cn"}],"primaryOutcomes":["Modified Rankin Scale (mRS)"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["zhengzhou-china"],"enrichment":{"headline":"Phase 3: testing TNK-tPA for Acute Ischemic Stroke","inPlainEnglish":"The goal of this clinical trial is to measure the how well it works and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI. The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to any","AIS with symptom onset 4.5-9 hours before enrollment, including wake-up stroke and unwitnessed stroke (onset time defined as when symptoms were first noticed);","DWI-FLAIR mismatch: visible lesion on DWI with no marked visible lesion on FLAIR;","DWI infarct core not exceeding one-third of the middle cerebral artery territory, one-half of the anterior cerebral artery territory, or one-half of the posterior cerebral artery territory;","First-ever stroke or previous stroke without significant disability (pre-stroke mRS ≤ 1);"],"whoShouldSkip":["Planned endovascular treatment;","Contradictory to MRI examination;","MRI image not qualified for evaluation;","Obvious head injuries or strokes within 3 months;","Subarachnoid or intracranial hemorrhage;","History of intracranial hemorrhage;","Intracranial tumor, arteriovenous malformation or aneurysm;"],"whatHappens":"If you join, the listed intervention(s) are TNK-tPA, Aspirin, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to measure the how well it works and safety of tenecteplase administered 4.5-9 hours after stroke onset (defined as the time the patient was first found with symptoms, including wake-up stroke and unwitnessed stroke) in patients with acute ischemic stroke (AIS) guided by DWI-FLAIR mismatch on MRI.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 564 people at Zhengzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.218Z"},{"nctId":"NCT07541170","title":"A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)","officialTitle":"A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Divarasib"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Nivolumab"}],"enrollment":400,"startDate":"2026-10-06","completionDate":"2032-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology\n* Participants must have had complete resection of NSCLC\n* Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy\n* Participants must be randomized within 12 weeks of their surgery date\n* No evidence of disease recurrence or metastatic disease\n* Documentation of the presence of a KRAS G12C mutation\n\nExclusion Criteria:\n\n* Participants who achieve pCR 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only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Disease-free Survival (DFS), as Determined by the Investigator"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab","nivolumab"],"locationSlugs":["clovis-california","bay-pines-florida","atlanta-georgia","boston-massachusetts","farmington-hills-michigan","reno-nevada","farmington-new-mexico","columbus-ohio","memphis-tennessee","rosario-argentina","capital-federal-argentina","ciudad-autonoma-buenos-aires-argentina","mar-del-plata-argentina","hasselt-belgium","mons-belgium","belo-horizonte-brazil","porto-alegre-brazil","itaja-brazil","s-o-paulo-brazil","montreal-canada","hefei-china","shenzhen-china","jinan-china","chengdu-china","hangzhou-china","beijing-china","changchun-china","foshan-china","guangzhou-china","hangzhouzhejiang-china","nanchang-china","nanjing-china","suzhou-china","taizhou-china","tianjin-china","barranquilla-colombia","bogota-d-c-colombia","florindablanca-colombia","medell-n-colombia","avignon-france","quimper-france","reims-france","suresnes-france","berlin-germany","bielefeld-germany","essen-germany","esslingen-am-neckar-germany","athens-greece","marousi-greece","thessaloniki-greece","hong-kong-hong-kong","shatin-hong-kong","cork-ireland","dublin-ireland","rome-italy","bergamo-italy","milan-italy","florence-italy","perugia-italy","peschiera-del-garda-vr-italy","gifu-japan","hiroshima-japan","hy-go-japan","ita-japan","bystra-poland","gda-sk-poland","kielce-poland","olsztyn-poland","warsaw-poland","wroc-aw-poland","lisbon-portugal","loures-portugal","seongnam-si-south-korea","busan-south-korea","daegu-south-korea","daejeon-south-korea","gyeonggi-do-south-korea","incheon-south-korea","jeollanam-do-south-korea","seoul-south-korea","palma-de-mallorca-spain","badalona-spain","sabadell-barcelona-spain","santa-cruz-de-tenerife-spain","bilbao-spain","a-coru-a-spain","alicante-spain","granada-spain","madrid-spain","m-laga-spain","seville-spain","zaragoza-spain","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Divarasib for Non-small Cell Lung Cancer","inPlainEnglish":"The main purpose of this study is to measure the how well it works of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1","Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology","Participants must have had complete resection of NSCLC","Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy","Participants must be randomly assigned within 12 weeks of their surgery date","No evidence of disease recurrence or metastatic disease","Documentation of the presence of a KRAS G12C mutation"],"whoShouldSkip":["Participants who achieve pCR following neoadjuvant treatment","Prior treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol","Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection","Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy","Active or history of autoimmune disease or immune deficiency","Significant cardiovascular disease"],"whatHappens":"If you join, the listed intervention(s) are Divarasib, Pembrolizumab, or Nivolumab. The registry lists allocation as randomized. The main purpose of this study is to measure the how well it works of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 104 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.658Z"},{"nctId":"NCT07542210","title":"Barriers and Facilitators of Persistence With Adjuvant Osimertinib","officialTitle":"Cross-sectional Qualitative Study to Identify Barriers and Facilitators of Persistence With 3rd Generation EGFR-TKI Osimertinib as Adjuvant Treatment (SECURE)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a cross-sectional, non-interventional qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 participants will be enrolled, comprising around 85 patients and 15 physicians. All participants will be interviewed online or in-person using a COM-B (Capability, Opportunity, Motivation - Behaviour) based guide. Interviews will be conducted in waves, recorded, transcribed, and analysed using both deductive and inductive methods.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[],"enrollment":100,"startDate":"2026-08-13","completionDate":"2026-10-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"For patient\n\nInclusion Criteria:\n\n* Adults (≥18 years) with NSCLC who have received osimertinib as the 3rd generation EGFR-TKI adjuvant therapy and meet one of the following: Patients who received adjuvant osimertinib for less than 34 months and discontinued treatment (off treatment), or Patients who received adjuvant osimertinib for at least 34 months (either off treatment or still on treatment).\n* For off treatment patients, discontinuation or completion of osimertinib is required to occur within 6 months by screening.\n* Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.\n\nExclusion Criteria:\n\n* Prior receipt of 3rd generation EGFR-TKI as adjuvant therapy as part of any interventional clinical trial.\n* Prior receipt of 1st generation EGFR-TKIs as adjuvant therapy.\n* Evidence of cognitive impairment that would likely to interfere with participation in an interview, as informally assessed during screening.\n* Unaware of or do not understand their own medical condition.\n\nFor physicians\n\nInclusion Criteria:\n\n* Licensed medical oncologists, thoracic surgeons, or pulmonologists with experience of prescribing osimertinib as adjuvant treatment and actively managing patients who will participate the interview.\n* Managed 5 patients with early-stage NSCLC receiving osimertinib within the past 6 months.\n* Holding a professional title equivalent to or higher than attending physician.\n* Willing and able to provide informed consent, participate in an online or in-person qualitative interview, and permit audio recording for research purposes.\n\nExclusion Criteria:\n\n* Unable or unwilling to follow study procedures.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Barriers to persistence","Facilitators of persistence"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Barriers and Facilitators of Persistence With Adjuvant Osimertinib","inPlainEnglish":"This is a cross-sectional, non-treatment qualitative study using individual interviews to investigate determinants of persistence with 3rd generation EGFR-TKI osimertinib as adjuvant therapy among patients with early-stage NSCLC in China. Approximately 100 you would be enrolled, comprising around 85 patients and 15 physicians.","whoItsFor":["Ages 18 Years to any","For off treatment patients, discontinuation or completion of osimertinib is required to occur within 6 months by screening"],"whoShouldSkip":["Prior receipt of 3rd generation EGFR-TKI as adjuvant therapy as part of any treatment clinical trial","Prior receipt of 1st generation EGFR-TKIs as adjuvant therapy","Evidence of cognitive impairment that would likely to interfere with participation in an interview, as informally assessed during screening","Unaware of or do not understand their own medical condition","who can join:","Licensed medical oncologists, thoracic surgeons, or pulmonologists with experience of prescribing osimertinib as adjuvant treatment and actively managing patients who will participate the interview","Managed 5 patients with early-stage NSCLC receiving osimertinib within the past 6 months"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.680Z"},{"nctId":"NCT07543289","title":"Hydroxyurea Optimisation in Sickle Cell Disease","officialTitle":"Pharmacogenetics and Model-Informed Optimisation of Hydroxyurea Therapy in Sickle Cell Disease Patients of Nigerian Descent","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ochuko Orherhe","sponsorClass":"OTHER","summary":"The wide interindividual variability in clinical response to hydroxyurea therapy in the management of sickle cell disease has limited its use. These variabilities have been linked to differences in pharmacodynamics, pharmacokinetics, and pharmacogenetics. This study, therefore, aims to enhance understanding of these factors as they relate to hydroxyurea therapy, with the overall goal of developing a precision medicine algorithm.\n\nThe study will be a prospective cohort pharmacokinetic study of 100 Nigerian patients with sickle cell disease, including current hydroxyurea users and naive patients. Pharmacodynamic markers will be collected to evaluate response. PopPK and PK-PD models will be developed in Monolix, exposure-response relationships will be analysed in R, and pregnancy, lactation, and paediatrics PBPK models will be developed in Simcyp or PK-SIM to inform dose optimisation.\n\nThis study aims to build a pharmacometric model by integrating differences in pharmacokinetics, pharmacodynamics, and pharmacogenetics of hydroxyurea, which could aid the optimisation of hydroxyurea for sickle cell patients in Nigeria.\n\nThe objectives of the study are i. To determine the prevalence of genetic polymorphisms in metabolic enzymes and transporters relevant to the disposition of hydroxyurea in the Nigerian sickle cell disease population, ii. To develop and validate an analytical method for the quantification of hydroxyurea using high-performance liquid chromatography.\n\niii. To evaluate the influence of genetic and other covariates on hydroxyurea disposition in the Nigerian sickle cell disease population using population pharmacokinetic modelling, iv. To investigate the relationship between hydroxyurea exposure and clinical outcomes (foetal haemoglobin, mean corpuscular volume, reduction in vaso-occlusive crises (VOC), and improved blood count) using pharmacokinetic-pharmacodynamic modelling, v. To develop physiologically-based pharmacokinetic (PBPK) models that could predict hydroxyurea concentrations in special populations of sickle cell disease patients in Nigeria i.e. pregnant women, lactating mothers, breastfed infants, and paediatrics.\n\nvi. To develop a dosing guideline for hydroxyurea therapy in Nigerian sickle cell patients.\n\nOverall, this study will provide scientific knowledge that can enhance clinical decision-making in sickle cell management within the Nigerian population, and the models could serve as a template to optimize hydroxyurea use in this population.","conditions":["Sickle Cell Disease"],"keywords":["Modelling","Genetic Polymorphism","Pharmacokinetics","Clinical Outcomes","Hydroxyurea","Pharmacogenetics"],"interventions":[{"type":"DRUG","name":"Hydroxyurea (HU)"}],"enrollment":100,"startDate":"2026-05-08","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with confirmed diagnosis of sickle cell disease (SCD) (e.g., HbSS, HbSC) and of Nigerian descent.\n* Patients currently on hydroxyurea therapy or hydroxyurea-naive patients who are willing to commence hydroxyurea therapy.\n* Patients whose genotypic profile for the major metabolising enzymes has been previously done e.g. CYP2D6.\n* Patients who consent to be part of the study\n\nExclusion Criteria:\n\n* Patients with severe comorbidities that may significantly alter pharmacokinetics (e.g., advanced renal or hepatic failure)\n* Patients in acute crisis at the time of sampling.\n* Patients with documented poor adherence to other medications previously on.\n* Pregnant females and lactating mothers.","locations":[{"facility":"Obafemi Awolowo University Teaching Hospital Complex","city":"Ile-Ife","state":"Osun State","country":"Nigeria","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ochuko M. Orherhe, M.Phil.","phone":"+2348051589453","email":"oorherhe@oauife.edu.ng"},{"name":"Babatunde A Adeagbo, PhD","phone":"+2348069019643","email":"badeagbo@oauife.edu.ng"}],"primaryOutcomes":["Increase in foetal haemoglobin"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["ile-ife-nigeria"],"enrichment":{"headline":"Not a traditional drug phase: testing Hydroxyurea (HU) for Sickle Cell Disease","inPlainEnglish":"The wide interindividual variability in clinical response to hydroxyurea therapy in the management of sickle cell disease has limited its use. These variabilities have been linked to differences in pharmacodynamics, pharmacokinetics, and pharmacogenetics.","whoItsFor":["Ages 18 Years to any","Patients with confirmed diagnosis of sickle cell disease (SCD) (e.g., HbSS, HbSC) and of Nigerian descent","Patients currently on hydroxyurea therapy or hydroxyurea-who have not tried this kind of treatment before patients who are willing to commence hydroxyurea therapy","Patients whose genotypic profile for the major metabolising enzymes has been previously done e.g. CYP2D6","Patients who consent to be part of the study"],"whoShouldSkip":["Patients with severe comorbidities that may significantly alter pharmacokinetics (e.g., advanced renal or hepatic failure)","Patients in acute crisis at the time of sampling","Patients with documented poor adherence to other medications previously on","Pregnant females and lactating mothers"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Ile-Ife. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.836Z"},{"nctId":"NCT07544654","title":"DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","officialTitle":"A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.","conditions":["Extrapulmonary Neuroendocrine Cancer (epNEC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Obrixtamig"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Etoposide"},{"type":"DEVICE","name":"Ventana DLL3 RxDx assay"}],"enrollment":390,"startDate":"2026-07-10","completionDate":"2029-12-13","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg/m2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg/m2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and/or carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia/fatigue, amenorrhea/menstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and/or CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.","locations":[{"facility":"Mayo Clinic","city":"Scottsdale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"City of Hope-Duarte-56419","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles","city":"Santa Monica","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Skip Viragh Outpatient Cancer Research Building","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic, Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan-Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Pittsburgh Medical Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt-Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Baylor University Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huntsman Cancer Institute","city":"Salt Lake City","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fred Hutchinson Cancer Research Center","city":"Seattle","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Reumatologico - OMI","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Britanico de Buenos Aires","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Medico Especializado Alexander Fleming","city":"Ciudad Autónoma de Bs As","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinica Privada Independencia","city":"Munro","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque S.A.","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal North Shore Hospital","city":"St Leonards","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flinders Medical Centre","city":"Bedford Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peter MacCallum Cancer Centre","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fiona Stanley Hospital","city":"Murdoch","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University of Graz","city":"Graz","state":"","country":"Austria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical University of Vienna","city":"Vienna","state":"","country":"Austria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Antwerpen","city":"Edegem","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Liège","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Amor","city":"Barretos","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto D'Or de Pesquisa E Ensino - Pe","city":"Recife","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto","city":"São José do Rio Preto","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICESP - Instituto do Cancer do Estado de Sao Paulo","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"A.C. Camargo","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthur J. E. Child Comprehensive Cancer Centre","city":"Calgary","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ottawa Hospital","city":"Ottawa","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oncologico FALP","city":"Providencia","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradford Hill- Centro de Investigacion Clinica","city":"Recoleta","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Alemana de Santiago S.A.","city":"Santiago","state":"","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing GoBroad Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital, Central South University","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Province Tumor Hospital","city":"Changsha","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Affiliated Cancer Hospital","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Cancer Hospital","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital,Sun Yat-sen University","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harbin Medical University Cancer Hospital","city":"Harbin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital, Shangdong University","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong Cancer Hospital","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Linyi Cancer Hospital","city":"Linyi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science and Technology","city":"Luoyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Cancer Hospital, Guangxi Medical University","city":"Nanning","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai General Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital","city":"Wuhan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Affiliated Hospital of Xi'an JiaoTong University","city":"Xi'an","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"First Affiliated Hospital of Xiamen University","city":"Xiamen","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Masaryk Memorial Cancer Institute","city":"Brno","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Hradec Kralove (FNHK)","city":"Hradec Králové","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aarhus University Hospital","city":"Aarhus N","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet","city":"Copenhagen","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Odense University Hospital","city":"Odense C","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Helsinki University Hospital","city":"Helsinki","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"KYS Sädesairaala","city":"Kuopio","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tampere University Hospital","city":"Tampere","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Turku University Hospital / TYKS","city":"Turku","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Beaujon","city":"Clichy","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP François Mitterrand","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Edouard Herriot","city":"Lyon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"INS Paoli-Calmettes","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOP Haut-Leveque","city":"Pessac","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTR Eugène Marquis","city":"Rennes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Rangueil - CHU de Toulouse","city":"Toulouse","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"DRK Kliniken Berlin Köpenick","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Bonn AöR","city":"Bonn","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Köln (AöR)","city":"Cologne","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Technische Universität Dresden","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Düsseldorf","city":"Düsseldorf","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Erlangen","city":"Erlangen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Freiburg","city":"Freiburg im Breisgau","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asklepios Klinik St Georg","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Heidelberg","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin der Johannes Gutenberg-Universität Mainz","city":"Mainz","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Westfälische Wilhelms-Universität Münster","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Würzburg AÖR","city":"Würzburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital-Hong Kong-20715","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Mary Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Soroka Univ. 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Chuo-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Nacional de Occidente/ Centro De Investigacion Biomedica De Occidente","city":"Guadalajara, Jalisco","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Health Pharma Professional Research S.A. de C.V.","city":"Mexico City","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Oncologico Personalizado","city":"México","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Oncologico Estatal ISSEMYM","city":"Toluca","state":"","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Jaliciense de Cancerología","city":"Zapopan","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nederlands Kanker Instituut - Antoni van Leeuwenhoek Amsterdam (METC 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Radiumhospitalet","city":"Oslo","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helse Stavanger, Stavanger Universitetssykehus","city":"Stavanger","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Olavs Hospital, Universitetssykehuset i Trondheim","city":"Trondheim","state":"","country":"Norway","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical University Gdansk","city":"Gdansk","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Silesian Medical University in Katowice","city":"Katowice","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IPO Lisboa Francisco Gentil, EPE","city":"Lisbon","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Lusiadas 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Hospital","city":"Uppsala","state":"","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital, Linkou","city":"Taoyuan City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Addenbrooke's Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western General Hospital","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie","city":"Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-012","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Overall survival (OS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","duarte-california","san-francisco-california","santa-monica-california","jacksonville-florida","atlanta-georgia","chicago-illinois","baltimore-maryland","boston-massachusetts","rochester-minnesota","st-louis-missouri","new-york-new-york","columbus-ohio","pittsburgh-pennsylvania","knoxville-tennessee","nashville-tennessee","dallas-texas","houston-texas","salt-lake-city-utah","seattle-washington","caba-argentina","ciudad-aut-noma-de-bs-as-argentina","munro-argentina","rosario-argentina","st-leonards-australia","bedford-park-australia","melbourne-australia","murdoch-australia","graz-austria","vienna-austria","brussels-belgium","edegem-belgium","leuven-belgium","li-ge-belgium","barretos-brazil","recife-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","calgary-canada","ottawa-canada","toronto-canada","providencia-chile","recoleta-chile","santiago-chile","beijing-china","changchun-china","changsha-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","hangzhou-china","harbin-china","jinan-china","linyi-china","luoyang-china","nanning-china","shanghai-china","wuhan-china","xian-china","xiamen-china","zhengzhou-china","brno-czechia","hradec-kr-lov-czechia","aarhus-n-denmark","copenhagen-denmark","odense-c-denmark","helsinki-finland","kuopio-finland","tampere-finland","turku-finland","clichy-france","dijon-france","lyon-france","marseille-france","pessac-france","rennes-france","toulouse-france","villejuif-france","berlin-germany","bonn-germany","cologne-germany","dresden-germany","d-sseldorf-germany","erlangen-germany","freiburg-im-breisgau-germany","hamburg-germany","heidelberg-germany","mainz-germany","m-nster-germany","t-bingen-germany","w-rzburg-germany","hong-kong-hong-kong","beersheba-israel","haifa-israel","jerusalem-israel","tel-aviv-israel","florence-italy","milan-italy","naples-italy","palermo-italy","roma-italy","verona-italy","aichi-nagoya-japan","chiba-kashiwa-japan","ehime-matsuyama-japan","fukuoka-fukuoka-japan","hokkaido-sapporo-japan","ishikawa-kanazawa-japan","kanagawa-yokohama-japan","kyoto-kyoto-japan","miyagi-sendai-japan","okayama-okayama-japan","osaka-osaka-japan","shizuoka-sunto-gun-japan","tokyo-chuo-ku-japan","guadalajara-jalisco-mexico","mexico-city-mexico","m-xico-mexico","toluca-mexico","zapopan-mexico","amsterdam-netherlands","groningen-netherlands","maastricht-netherlands","rotterdam-netherlands","grafton-auckland-new-zealand","bergen-norway","oslo-norway","stavanger-norway","trondheim-norway","gdansk-poland","katowice-poland","lisbon-portugal","porto-portugal","seoul-south-korea","badalona-spain","barcelona-spain","lhospitalet-del-llobregat-spain","madrid-spain","m-laga-spain","pamplona-spain","santander-spain","seville-spain","valencia-spain","gothenburg-sweden","lund-sweden","uppsala-sweden","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan","cambridge-united-kingdom","edinburgh-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Obrixtamig for Extrapulmonary Neuroendocrine Cancer (epNEC)","inPlainEnglish":"This study is open to adults with advanced extrapulmonary neuroendocrine cancer. this study wants to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone.","whoItsFor":["Ages 18 Years to any","Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)","Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue","Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)","Eastern Cooperative Oncology Group (ECOG) score of 0 or 1"],"whoShouldSkip":["Presence of leptomeningeal disease and/or carcinomatous meningitis","Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma","Patients with neuroendocrine prostate cancer","Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition","Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)","Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)","Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)"],"whatHappens":"If you join, the listed intervention(s) are Obrixtamig, Carboplatin, or Etoposide. The registry lists allocation as randomized. This study is open to adults with advanced extrapulmonary neuroendocrine cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 390 people at 170 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.420Z"},{"nctId":"NCT07544992","title":"Locoregional Administration of Genetically Engineered Cells (EGFR/IL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas","officialTitle":"A Phase 1 Trial to Evaluate the Safety of EGFR/IL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers.","conditions":["Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells"},{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"FDG-Positron Emission Tomography"},{"type":"PROCEDURE","name":"Intracranial Catheter Placement"},{"type":"PROCEDURE","name":"Leukapheresis"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Resection"}],"enrollment":24,"startDate":"2026-05-26","completionDate":"2031-11-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Main Inclusion Criteria\n\n* Documented informed consent of the participant and/or legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.\n* Age 18 years and older.\n* KPS ≥ 70%, ECOG ≤ 2 (Appendix A).\n* Life expectancy ≥ 4 weeks.\n* Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.\n* Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.\n* COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):\n\n  * IL13Rα2+ expression by IHC \\> 20, and\n  * EGFR gene-altered by NGS or FISH analysis\n* No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.\n* WBC \\> 2000 /dl (or ANC ≥ 1,000/mm3)\n* Platelets ≥ 75,000/mm3\n* Hemoglobin \\> 9g/dL\n* Total bilirubin ≤ 1.5x ULN\n* AST ≤ 2.5x ULN\n* ALT ≤ 2.5x ULN\n* Serum creatinine ≤1.6 mg/dL\n* O2 saturation ≥ 95% on room air.\n* Seronegative for HIV Ag/Ab combo, HCV, and active HBV\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.\n\nMain Exclusion Criteria\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.\n* Participant has not yet recovered from toxicities of prior therapy.\n* Participant has received any live vaccine within 30 days prior to enrollment.\n* Uncontrolled seizure activity and/or clinically evident progressive encephalopathy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Clinically significant uncontrolled illness.\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.\n* Other active malignancy.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of adverse events","Maximum tolerated dose (MTD)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":["car-t"],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Phase 1: testing Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells for Recurrent Astrocytoma, IDH-Mutant, Grade 4","inPlainEnglish":"This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR/IL13Rα2 pool-CAR T cells are a type of CAR T cell therapy.","whoItsFor":["Ages 18 Years to any","Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval","Age 18 years and older","KPS ≥ 70%, ECOG ≤ 2 (Appendix A)","Life expectancy ≥ 4 weeks","Relapsed disease: radiographic evidence of recurrence/progression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy","COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):","IL13Rα2+ expression by IHC \\> 20, and"],"whoShouldSkip":["Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded","Participant has not yet recovered from toxicities of prior therapy","Participant has received any live vaccine within 30 days prior to enrollment","Uncontrolled seizure activity and/or clinically evident progressive encephalopathy","History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent","Clinically significant uncontrolled illness","Active autoimmune disease requiring systemic immunosuppressive therapy"],"whatHappens":"If you join, the listed intervention(s) are Autologous Anti-EGFR/Anti-IL13Ralpha2 CAR T-cells, Biopsy Procedure, or Biospecimen Collection. The registry lists allocation as na. This phase I trial studies the side effects and best dose of EGFR/IL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at Duarte. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.490Z"},{"nctId":"NCT07545317","title":"Real-World Study of IL-23 Inhibitors in Active Crohn's Disease","officialTitle":"Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sixth Affiliated Hospital, Sun Yat-sen University","sponsorClass":"OTHER","summary":"The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:\n\n* What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?\n* What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?\n\nThis is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.\n\nParticipants will:\n\n* Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors\n* Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52\n* Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available\n* Be monitored for adverse events and treatment changes during the study\n* Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response","conditions":["Crohn's Disease"],"keywords":["Crohn's disease","IL-23 inhibitor","TNF inhibitor","Bio-naive","Real-world study","Observational cohort","Clinical remission","Endoscopic remission"],"interventions":[{"type":"DRUG","name":"IL-23 inhibitor"},{"type":"DRUG","name":"TNF inhibitors"}],"enrollment":665,"startDate":"2026-04-16","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 to 75 years\n2. Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria\n3. Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) \\>=6 for ileocolonic or colonic disease, or SES-CD \\>=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) \\>=250 ug/g\n4. Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors\n5. Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted\n6. If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid\n7. Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements\n8. Additional criteria for the concurrent prospective TNF inhibitor cohort used in the nested comparative analysis: (1) Participants must be bio-naive, defined as no prior exposure to any biologic agent (including TNF inhibitors, vedolizumab, ustekinumab, etc.) or targeted small-molecule therapy (such as JAK inhibitors), (2) Participants must also meet Inclusion Criteria 1, 2, 3, 6, and 7 above, (3) Participants must be planned to initiate TNF inhibitor therapy in routine clinical practice\n\nExclusion Criteria:\n\n1. Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents\n2. Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis\n3. Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction\n4. Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe/recurrent infection history\n5. Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence\n6. Pregnancy, breastfeeding, or planned pregnancy during the study period\n7. Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence\n8. Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial","locations":[{"facility":"The Sixth Affiliated Hospital, Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Wang, MD & PhD","phone":"+86-020-82514458","email":"weiwang0303@gmail.com"}],"primaryOutcomes":["Clinical Remission Rate"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Not a traditional drug phase: testing IL-23 inhibitor for Crohn's Disease","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are: * What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria","Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors","Prior treatment history for the IL-23 inhibitor cohort may include biologic-who have not tried this kind of treatment before or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted","If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid"],"whoShouldSkip":["Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents","Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis","Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction","Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe/recurrent infection history","Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence","Pregnancy, breastfeeding, or planned pregnancy during the study period","Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 665 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.269Z"},{"nctId":"NCT07545759","title":"A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)","officialTitle":"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 36 weeks.","conditions":["Irritable Bowel Syndrome","Diarrhea"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY3537031"},{"type":"DRUG","name":"Placebo"}],"enrollment":531,"startDate":"2026-05-06","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\<25% of bowel movements with BSFS Types 1 or 2\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n  * Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization\n* Have had no major changes in diet in the 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality","locations":[{"facility":"Del Sol Research Management - Mesa","city":"Mesa","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smart Cures Clinical Research","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Om Research LLC","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"United Medical Doctors - Los Alamitos","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Osceola","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic - First","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Health Partners","city":"New Albany","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Health Partners","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center","city":"Wyoming","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester, Minnesota","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ohio Gastroenterology","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Gastroenterology","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biopharma Informatic, LLC","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Star Research Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sint Vincentius Ziekenhuis","city":"Antwerp","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AZ Sint-Lucas","city":"Bruges","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel","city":"Brussels","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Antwerp University Hospital","city":"Edegem","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AZ Maria Middelares","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Sint-Lucas","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"UZ Gent","city":"Ghent","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Chc Montlégia","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"AZ Delta vzw","city":"Roeselare","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bluewater Clinical Research Group Inc.","city":"Sarnia","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scarborough Center for Inflammatory Bowel Disease","city":"Scarborough","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"ClinSurge Research - 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Hamburg","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinische Forschung Karlsruhe","city":"Karlsruhe","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"AmBeNet GmbH","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureMeds Offenbach","city":"Offenbach","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sai Gastroenterology/Proctology Clinic","city":"Fujiidera","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokai University Hospital","city":"Isehara","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aoyama Internal Medicine Clinic","city":"Kobe","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aono Clinic","city":"Kobe","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hattori Clinic - 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The study drug will be administered subcutaneously (SC) (under the skin) when compared with dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 75 Years","Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and \\<25% of bowel movements with BSFS Types 1 or 2","Based on the daily eDiary collection during the screening period:","Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization","Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization","Have had no major changes in diet in the 4 weeks prior to screening"],"whoShouldSkip":["Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria","Have a history of inflammatory or immune-mediated gastrointestinal disorders","Have a known clinically significant gastric emptying abnormality"],"whatHappens":"If you join, the listed intervention(s) are LY3537031, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and how well it works in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 531 people at 89 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.430Z"},{"nctId":"NCT07545772","title":"A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)","officialTitle":"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-C","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.\n\nThe study will last approximately 36 weeks.","conditions":["Irritable Bowel Syndrome","Constipation"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY3537031"},{"type":"DRUG","name":"Placebo"}],"enrollment":342,"startDate":"2026-04-29","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7\n* Based on the daily eDiary collection during the screening period:\n\n  * Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization\n\nExclusion Criteria:\n\n* Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria\n* Have a history of inflammatory or immune-mediated gastrointestinal disorders\n* Have a known clinically significant gastric emptying abnormality","locations":[{"facility":"Del Sol Research Management - 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The study drug will be administered subcutaneously (SC) (under the skin) when compared with dummy treatment (placebo).","whoItsFor":["Ages 18 Years to 75 Years","Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7","Based on the daily eDiary collection during the screening period:","Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization"],"whoShouldSkip":["Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, mixed IBS, or unclassified IBS by the Rome IV criteria","Have a history of inflammatory or immune-mediated gastrointestinal disorders","Have a known clinically significant gastric emptying abnormality"],"whatHappens":"If you join, the listed intervention(s) are LY3537031, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and how well it works in participants with Irritable Bowel Syndrome-Constipation (IBS-C).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 342 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.428Z"},{"nctId":"NCT07546500","title":"A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression","officialTitle":"A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator's Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc","sponsorClass":"INDUSTRY","summary":"This is a randomized, Phase 3 trial designed to evaluate the efficacy and safety of azenosertib compared to Investigator's choice of chemotherapy in subjects with platinum-resistant ovarian cancer whose tumors are positive for cyclin E1 protein expression.","conditions":["Ovarian Cancer"],"keywords":["Platinum-Resistant Ovarian Cancer (PROC)","OvCa"],"interventions":[{"type":"DRUG","name":"Investigator's choice of Chemotherapy"},{"type":"DRUG","name":"Azenosertib"}],"enrollment":420,"startDate":"2026-04-17","completionDate":"2028-05-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 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Significant gastrointestinal abnormalities, including an inability to take oral medication, requirement for IV alimentation, active peptic ulcer, chronic diarrhea or vomiting considered to be clinically significant in the judgment of the Investigator, or prior surgical procedures affecting absorption.\n   4. Any evidence of small bowel obstruction as determined by air/fluid levels on computed tomography (CT) scan, recent hospitalization for small bowel obstruction within 3 months before randomization, or recurrent paracentesis or thoracentesis within 6 weeks before randomization.\n   5. Active, uncontrolled infection. Subjects with an infection receiving treatment (antibiotic, antifungal, or antiviral) must have completed such treatment and the infection must be considered controlled/resolved (and afebrile) by the Investigator for at least 7 days before randomization\n   6. Myocardial impairment of any cause resulting in heart failure by New York Heart Association criteria (Class II, III or IV).\n   7. Medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results\n5. Any of the following treatment interventions within the specified time frame before randomization:\n\n   1. Hospitalization within 14 days\n   2. Major surgery within 28 days\n   3. Any chemotherapy or targeted tumor therapy within 21 days or 5 half-lives (whichever is shorter)\n   4. Radiation therapy within 21 days\n   5. Autologous or allogeneic stem cell transplant within 3 months\n   6. Current use of any other investigational drug therapy \\< 28 days or 5 half-lives (whichever is shorter)\n6. Inability to discontinue treatment with prescription or nonprescription drugs that are prohibited per protocol.\n7. 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Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.160Z"},{"nctId":"NCT07549061","title":"Vebreltinib Plus Chemotherapy as First-line Treatment for MET-overexpressing NSCLC","officialTitle":"Vebreltinib in Combination With Platinum-based Doublet Chemotherapy as First-line Treatment for Driver Mutation-negative, MET-overexpressing, PD-L1 TPS < 50%, Locally Advanced or Metastatic Non-small Cell Lung Cancer: a Prospective, Single-arm, Phase II Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Shanghai Chest Hospital","sponsorClass":"OTHER","summary":"To explore the efficacy and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver mutation-negative, MET-overexpressing, PD-L1 TPS \\< 50%, locally advanced or metastatic NSCLC .","conditions":["NSCLC (Advanced Non-small Cell Lung Cancer)"],"keywords":["NSCLC","Vebreltinib","Met","Overexpression"],"interventions":[{"type":"DRUG","name":"Vebreltinib"},{"type":"DRUG","name":"Chemotherapy"}],"enrollment":19,"startDate":"2026-09-03","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria\n\nPatients must meet all of the following inclusion criteria:\n\n1. Provide written informed consent before initiation of any study-specific procedure and be willing and able to comply with study procedures.\n2. Be aged ≥18 years.\n3. Have histologically or cytologically confirmed NSCLC. (pathology reports from outside institutions are acceptable).\n4. Have newly diagnosed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy according to the AJCC 9th edition staging system.\n5. Have no prior systemic anticancer therapy for advanced or metastatic disease. Prior neoadjuvant or adjuvant systemic therapy, definitive chemoradiotherapy or radiotherapy is permitted provided that treatment was completed ≥12 months before recurrence.\n6. Have an ECOG performance status of 0-2.\n7. Have no actionable driver oncogene alteration identified by tissue and/or blood-based molecular testing. At a minimum, testing must exclude EGFR sensitising mutations, ALK rearrangements, ROS1 rearrangements, RET fusions, NTRK fusions, KRAS G12C mutations, BRAF V600E mutations, MET exon 14 skipping alterations and other actionable alterations according to current clinical practice and locally available testing. Concurrent MET amplification is permitted provided that the tumour meets the prespecified MET protein overexpression criterion.\n8. Have MET protein overexpression, defined as moderate-to-strong (2+ or 3+) MET staining in ≥50% of viable tumour cells by IHC.\n9. Have a PD-L1 TPS \\<50%\n10. Have an estimated life expectancy of at least 3 months.\n11. Have at least one measurable lesion according to RECIST version 1.1.\n12. Have adequate organ function as defined by the following laboratory criteria:\n\n1\\) absolute neutrophil count ≥1.5 × 10⁹/L; 2) hemoglobin ≥90 g/L; 3) platelets ≥75 × 10⁹/L; 4) total serum bilirubin ≤1.5 × ULN; 5) AST and ALT ≤3 × ULN, or ≤5 × ULN in patients with liver metastases; 6) serum creatinine \\<1.5 × ULN. 7) creatinine clearance \\>50 mL/min, calculated using the Cockcroft-Gault formula.\n\n13\\. Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose and all participants of reproductive potential must agree to use effective contraception from informed consent until 3 months after the last dose of study treatment.\n\nExclusion criteria\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1\\. Central nervous system conditions\n\n1. Spinal cord compression or symptomatic, unstable brain metastases requiring urgent local treatment\n2. Patients with symptomatic brain metastases may be eligible if definitive local treatment has been completed, corticosteroid therapy has been discontinued, and neurological status has remained stable for at least 2 weeks after completion of definitive treatment and corticosteroid therapy.\n3. Asymptomatic brain metastases may be permitted if, in the investigator's judgement, immediate local treatment is not clinically indicated.\n\n2\\. Prior treatment and medication history\n\n1. Major surgery, including intrathoracic, intra-abdominal, or intrapelvic surgery, within 4 weeks before enrolment, or failure to recover adequately from the effects of previous surgery. Thoracoscopic biopsy and mediastinoscopy are not considered major surgery; patients may be enrolled ≥1 week after these procedures if adequately recovered.\n2. Treatment with traditional Chinese medicines or Chinese patent medicines with an antitumour indication within 1 week before the first dose of study treatment.\n3. Concomitant treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors that cannot be discontinued for at least 1 week before initiation of study treatment and avoided during study treatment.\n4. Any prior systemic antitumour therapy for advanced or metastatic NSCLC, including chemotherapy, immunotherapy, biologic therapy, targeted therapy, or investigational agents. For patients with recurrent disease, prior neoadjuvant or adjuvant systemic therapy, or definitive radiotherapy or chemoradiotherapy, with or without immunotherapy, biologic therapy, or investigational agents, is permitted provided that treatment was completed ≥12 months before documented disease recurrence.\n5. Radiotherapy involving \\>30% of the bone marrow or radiotherapy with a large treatment field within 4 weeks before the first dose of vebreltinib.\n6. Use of any investigational drug within 2 weeks before the first dose of study treatment or concurrent participation in another interventional clinical trial.\n\n3\\. Other malignancies Diagnosis of another malignancy requiring active treatment within the previous 3 years, except for completely resected basal cell carcinoma or squamous cell carcinoma of the skin, or completely resected carcinoma in situ without evidence of recurrence.\n\n4\\. Active infection and pulmonary or gastrointestinal conditions\n\n1. Active infection requiring systemic anti-infective treatment within 2 weeks before the first dose of study treatment, including clinically significant pneumonia.\n2. Active tuberculosis or other clinically significant uncontrolled infection.\n3. Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, as defined by the following:\n\n   * hepatitis B: positive hepatitis B surface antigen (HBsAg) with HBV DNA ≥500 IU/mL;\n   * hepatitis C: positive HCV antibody with detectable HCV RNA;\n   * HIV infection: positive HIV antibody;\n4. History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring systemic corticosteroid treatment, or current active interstitial lung disease requiring treatment or clinical intervention.\n5. Active gastrointestinal disease or other conditions that may significantly affect the absorption, distribution, metabolism, or excretion of oral vebreltinib, including active ulcerative gastrointestinal lesions, uncontrolled nausea, vomiting or diarrhoea, clinically significant malabsorption syndrome, in·ability to swallow oral medication, or previous major gastrointestinal surgery that may affect drug absorption.\n\n5\\. Hypersensitivity Known hypersensitivity to vebreltinib, platinum compounds, pemetrexed, gemcitabine, nab-paclitaxel, or any of their excipients, where applicable to the planned treatment regimen.\n\n6\\. Other serious medical conditions Any serious, uncontrolled, or clinically significant medical condition that, in the investigator's judgement, could increase the risk associated with study treatment, interfere with the interpretation of study results, compromise protocol compliance, or otherwise make the participant unsuitable for the study. This includes, but is not limited to, severe or uncontrolled psychiatric disorders, active primary immunodeficiency, or a history of allogeneic organ transplantation.\n\n7\\. Pregnancy and lactation Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use highly effective contraception during the study treatment period and for 3 months after the last dose of study treatment.\n\n8\\. Other conditions affecting study participation Any other condition or circumstance that, in the investigator's judgement, would make the participant unsuitable for study participation or would compromise participant safety, study compliance, or the integrity of study assessments.","locations":[{"facility":"241 West Huaihai Road, Xuhui District, Shanghai, 200030, China.","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Nie","phone":"021-63846590","email":"niewei-1001@163.com"}],"primaryOutcomes":["Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing Vebreltinib for NSCLC (Advanced Non-small Cell Lung Cancer)","inPlainEnglish":"To explore the how well it works and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver mutation-negative, MET-overexpressing, PD-L1 TPS \\< 50%, locally advanced or metastatic NSCLC .","whoItsFor":["Ages 18 Years to any","Patients must meet all of the following who can join:","Have histologically or cytologically confirmed NSCLC. (pathology reports from outside institutions are acceptable)","Have newly diagnosed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy according to the AJCC 9th edition staging system","Have no prior systemic anticancer therapy for advanced or metastatic disease. Prior neoadjuvant or adjuvant systemic therapy, definitive chemoradiotherapy or radiotherapy is permitted provided that treatment was completed ≥12 months before recurrence","Have an how well you can do daily activities (ECOG score) of 0-2","Have MET protein overexpression, defined as moderate-to-strong (2+ or 3+) MET staining in ≥50% of viable tumour cells by IHC","Have a PD-L1 TPS \\<50%"],"whoShouldSkip":["Participants meeting any of the following criteria will be excluded from the study:","1\\. Central nervous system conditions","Spinal cord compression or symptomatic, unstable brain metastases requiring urgent local treatment","Asymptomatic brain metastases may be permitted if, in the investigator's judgement, immediate local treatment is not clinically indicated","2\\. Prior treatment and medication history","Treatment with traditional Chinese medicines or Chinese patent medicines with an antitumour indication within 1 week before the first dose of study treatment","Concomitant treatment with strong CYP3A4 inducers or strong CYP3A4 inhibitors that cannot be discontinued for at least 1 week before initiation of study treatment and avoided during study treatment"],"whatHappens":"If you join, the listed intervention(s) are Vebreltinib, or Chemotherapy. The registry lists allocation as na. To explore the how well it works and safety of vebreltinib plus platinum-doublet chemotherapy as first-line therapy in patients with driver mutation-negative, MET-overexpressing, PD-L1 TPS \\< 50%, locally advanced or metastatic NSCLC .","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 19 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.710Z"},{"nctId":"NCT07549516","title":"A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany","officialTitle":"A Non-Interventional Study on the Tolerability, Safety and Effectiveness of Asciminib in Newly Diagnosed and Pre-treated Patients With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in the Chronic Phase in Germany - the ASC2ADHERE Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The aim of this study is to assess the real-world effectiveness of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) patients who were either newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor (TKI).","conditions":["Leukemia, Chronic Myeloid"],"keywords":["Asciminib","CML-CP","Philadelphia chromosome-positive","Real-world evidence","Non-interventional study","Germany","BCR::ABL1","Major Molecular Response","Adherence","MARS-5","EORTC QLQ-C30","EORTC QLQ-CML24","WPAI-GH","Tyrosine kinase inhibitors"],"interventions":[],"enrollment":380,"startDate":"2026-04-17","completionDate":"2030-09-30","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Written informed consent must be obtained before participation in the study/prior to any study-related documentation.\n2. Adult patients (≥18 years of age) with a confirmed diagnosis of Ph+ CML-CP. The presence of the Philadelphia chromosome may alternatively be confirmed by molecular detection of a BCR::ABL1 fusion gene/transcript (e.g., by reverse transcription polymerase chain reaction (RT-PCR)), in accordance with the World Health Organization (WHO) 2022 classification.\n3. Patients who are either newly diagnosed or have received treatment with exactly one prior TKI. Prior TKI treatment is only permitted for patients in the Asciminib Cohort. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be newly diagnosed and must not have received any prior TKI treatment.\n4. Patients for whom the treating physician has made a clinical decision to initiate treatment with asciminib or another TKI (imatinib, dasatinib, bosutinib, nilotinib) as part of routine care. The clinical decision for treatment must have been made prior to enrollment. Treatment must not have started more than 14 days before study inclusion, and treatment may also begin after baseline assessment.\n5. Patients willing to participate in routine follow-up visits and complete patient-reported outcome questionnaires over the course of the study.\n\nExclusion criteria:\n\n1. Patients with contraindications to their respective chronic myeloid leukemia (CML) treatment as per the applicable Summary of Product Characteristics (SmPC) and relevant national treatment guidelines (e.g. Onkopedia CML), as well as additional disease- or treatment-related characteristics associated with distinct clinical scenarios that differ from the intended study population, including situations with specific treatment requirements or limited comparability, in which reliable interpretation of study outcomes may not be feasible, including the following asciminib specific considerations:\n\n   * In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3, e1a3).\n   * In second-line treatment:\n\n     * known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C).\n     * presence of the BCR::ABL1 T315I mutation, regardless of eligibility for treatment according to SmPC (e.g., specific indication and dosing regimens).\n2. Patients receiving or planned to receive asciminib or other TKIs outside the approved label (off-label use), including use in unapproved dosing regimens or frequency not covered by the respective SmPC.\n3. Patients currently participating in an interventional clinical trial.\n4. Patients unable or unwilling to provide written informed consent.\n5. Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments.\n6. Patients for whom long-term follow-up is not feasible due to expected relocation or other logistical constraints.\n7. The restriction to a maximum of one prior ATP-competitive TKI applies exclusively to patients treated with asciminib. Patients in the comparator cohorts (imatinib, dasatinib, bosutinib, nilotinib) must be TKI-naïve and are included at the start of their first-line TKI therapy and are not eligible if they have received any prior TKI treatment.","locations":[{"facility":"Novartis Investigative Site","city":"Baden-Baden","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Heidenheim","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Schwäbisch Hall","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Winnenden","state":"Baden-Wurttemberg","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative 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Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Percentage of Patients With Major Molecular Response (MMR) at 12 Months"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["baden-baden-germany","heidenheim-germany","schw-bisch-hall-germany","winnenden-germany","aschaffenburg-germany","augsburg-germany","donauw-rth-germany","herrsching-am-ammersee-germany","kempten-allg-u-germany","landsberg-am-lech-germany","munich-germany","regensburg-germany","bremerhaven-germany","kassel-germany","offenbach-germany","goslar-germany","rotenburg-w-mme-germany","twistringen-germany","cologne-germany","solingen-germany","wesel-germany","zittau-germany","halle-germany","merseburg-germany","oldenburg-in-holstein-germany","altenburg-germany","saalfeld-germany","amberg-germany","bad-friedrichshall-germany","bad-liebenwerda-germany","bad-saarow-germany","berlin-germany","buchholz-nordheide-germany","cottbus-germany","deggendorf-germany","detmold-germany","dorfen-germany","dortmund-germany","dresden-germany","d-ren-germany","erfurt-germany","eschweiler-germany","g-ttingen-germany","hanover-germany","hildesheim-germany","kiel-germany","leipzig-germany","leverkusen-germany","mutlangen-germany","naunhof-germany","neuss-germany","offenburg-germany","oldenburg-germany","parchim-germany","potsdam-germany","schorndorf-germany","schwetzingen-germany","soest-germany","stade-germany","torgau-germany","ulm-germany","wetzlar-germany"],"enrichment":{"headline":"A Study on the Tolerability, Safety and Effectiveness of Asciminib in Patients With Philadelphia Chromosome…","inPlainEnglish":"The aim of this study is to assess the real-world effectiveness of asciminib in Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) patients who were either newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor (TKI).","whoItsFor":["Ages 18 Years to 100 Years"],"whoShouldSkip":["In first- or second-line treatment: presence of BCR::ABL1 fusion transcripts lacking exon a2 (e.g. e13a3, e14a3, e1a3)","In second-line treatment:","known BCR::ABL1 mutations associated with partial or complete resistance to asciminib (e.g. M244V, F359I/V/C)","presence of the BCR::ABL1 T315I mutation, regardless of eligibility for treatment according to SmPC (e.g., specific indication and dosing regimens)","Patients receiving or planned to receive asciminib or other TKIs outside the approved label (off-label use), including use in unapproved dosing regimens or frequency not covered by the respective SmPC","Patients currently participating in an treatment clinical trial","Patients who are unable to reliably complete patient-reported outcome questionnaires due to cognitive or language limitations relevant to the study assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 380 people at 63 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.822Z"},{"nctId":"NCT07554339","title":"A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015)","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.\n\nThe goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.","conditions":["Non-small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Calderasib"},{"type":"BIOLOGICAL","name":"Durvalumab"},{"type":"OTHER","name":"Placebo to MK-1084"}],"enrollment":310,"startDate":"2026-06-18","completionDate":"2032-12-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology.\n* Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression.\n* Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research.\n* Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result.\n* If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n* Has a body weight ≥35 kg.\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of small cell lung cancer or mixed tumors with small cell elements.\n* Has a gastrointestinal disorder affecting absorption or is unable to swallow orally administered medication.\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous clear history of inflammatory bowel disease.\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has received prior treatment (other than definitive CCRT) for NSCLC.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has a history of, or has current, (noninfectious) pneumonitis/interstitial lung disease that required/requires steroids.\n* Has an active infection requiring systemic therapy.\n* Has a history of stem cell/solid organ transplant.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","locations":[{"facility":"Low Country Cancer Care ( Site 0155)","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duly Healthcare ( Site 0158)","city":"Lisle","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NHO Revive Research Institute LLC ( Site 0118)","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute of New Jersey ( Site 0100)","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Oncology Hematology P.C ( Site 9000)","city":"Albany","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WakeMed Raleigh Campus ( Site 0144)","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists ( Site 0114)","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0301)","city":"Ciudad Autonoma de Buenos Aires.","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires. ( Site 0300)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Adventista Belgrano ( Site 0304)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigaciones Clínicas Mar del Plata ( Site 0303)","city":"Mar del Plata","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Britanico de Buenos Aires ( Site 0305)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque ( Site 0302)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northern Beaches Hospital ( Site 2401)","city":"Frenchs Forest","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Misericordiae Limited ( Site 2402)","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Alexandra Hospital ( Site 2406)","city":"Woolloongabba","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frankston Hospital ( Site 2403)","city":"Frankston","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA ( Site 0406)","city":"Fortaleza","state":"Ceará","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"AFECC ASSOCIACAO FEMININA EDUCACAO COMBATE CANCER ( Site 0416)","city":"Vitória","state":"Espírito Santo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0415)","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEPON ( Site 0413)","city":"Florianópolis","state":"Santa Catarina","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0401)","city":"Barretos","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anhui Provincial Cancer Hospital ( Site 2209)","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital ( Site 2226)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Peking Union Medical College Hospital ( Site 2220)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Cancer Hospital ( Site 2232)","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital Affiliated to Xiamen University ( Site 2213)","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xiamen University. ( Site 2239)","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Guangzhou Medical University ( Site 2211)","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guilin Medical University ( Site 2212)","city":"Guilin","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangxi Medical University Cancer Hospital ( Site 2202)","city":"Nanning","state":"Guangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fourth Hospital of Hebei Medical University ( Site 2201)","city":"Shijiazhuang","state":"Hebei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 2206)","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital ( Site 2203)","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital Of Central South University ( Site 2207)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital ( Site 2214)","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital ( Site 2224)","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong Cancer Hospital ( Site 2200)","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Chest Hospital ( Site 2229)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital affiliated to Fudan University ( Site 2215)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center ( Site 2216)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Provincial Cancer Hospital ( Site 2227)","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer hospital. 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2005)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shalimov Institute of Surgery and Transplantation ( Site 2003)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velindre Cancer Centre ( Site 2104)","city":"Cardiff","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St James's University Hospital ( Site 2100)","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-Free Survival 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3: testing Calderasib for Non-small Cell Lung Cancer","inPlainEnglish":"Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has a histological or cytological diagnosis of locally advanced, unresected Stage II (node-positive) to III non-small cell lung cancer (NSCLC) with predominantly nonsquamous histology","Has completed definitive platinum-based concurrent chemoradiotherapy (CCRT) prior to enrollment, without disease progression","Has provided a tumor tissue sample for central laboratory testing of Kirsten rat sarcoma G12C (KRAS G12C) status, programmed cell death ligand 1 (PD-L1) status, and biomarker research","Tumor tissue sample has a demonstrated presence of KRAS G12C mutation and an evaluable PD-L1 status result","If human immunodeficiency virus (HIV)-infected, has well-controlled HIV on antiretroviral therapy (ART)","If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Calderasib, Durvalumab, or Placebo to MK-1084. The registry lists allocation as randomized. Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 310 people at 115 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.722Z"},{"nctId":"NCT07554378","title":"A Multilevel Intervention to Prevent Noise Exposure in Farmworkers","officialTitle":"A Multilevel Intervention to Prevent Noise Exposure in Farmworkers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"San Diego State University","sponsorClass":"OTHER","summary":"This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. Farmworkers are often exposed to high levels of noise from machinery, which can lead to hearing loss over time.\n\nFarms will be randomly assigned to either receive the program or serve as a comparison group. The program includes a short educational video, group discussion, and hands-on training on how to use hearing protection (such as earplugs). Supervisors will also receive brief training on how to support hearing protection use in the workplace.\n\nParticipants will wear a small device (dosimeter) during a work shift to measure noise exposure before the program and again about one month later. Participants will also complete surveys about their knowledge, attitudes, and behaviors related to hearing protection.\n\nA subset of participants will be invited to take part in interviews to understand barriers and facilitators to using hearing protection and implementing the program.\n\nThe results of this study will help inform future efforts to improve hearing health and reduce noise exposure in agricultural settings.","conditions":["Noise Exposure","Hearing Loss, Noise-Induced","Occupational Exposure"],"keywords":["farmworkers","agriculture","hearing protection","earplugs","occupational noise","hearing conservation","implementation science","Community Health Workers","Workplace intervention","Cluster randomized trial"],"interventions":[{"type":"BEHAVIORAL","name":"Multilevel Hearing Protection Training"}],"enrollment":200,"startDate":"2026-10-30","completionDate":"2031-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Currently employed as a farmworker or supervisor at a participating farm\n* Able to provide informed consent\n* Able to understand and communicate in Spanish or English\n\nExclusion Criteria:\n\n* Not currently working at a participating farm at the time of recruitment\n* Unable or unwilling to wear a personal noise dosimeter during a work shift\n* Unable to complete study procedures (e.g., surveys or training)","locations":[{"facility":"San Diego State University","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laura Coco, PhD, AuD","phone":"16195943151","email":"lcoco@sdsu.edu"}],"primaryOutcomes":["Change in Time-Weighted Average Noise Exposure (dBA)","Change in Noise Dose (%)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: Multilevel Hearing Protection Training for Noise Exposure","inPlainEnglish":"This study will test a program to reduce noise exposure and prevent hearing loss among farmworkers. 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Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:35.048Z"},{"nctId":"NCT07555938","title":"Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Participants With Previously Treated Multiple Myeloma","officialTitle":"A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone Versus Standard of Care in Patients With Multiple Myeloma Who Have Received One to Three Prior Lines of Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cevostamab"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Daratumumab"},{"type":"DRUG","name":"Elotuzumab"},{"type":"DRUG","name":"Carfilzomib"}],"enrollment":380,"startDate":"2026-06-23","completionDate":"2028-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment.\n* Individuals with ECOG Performance Status of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible\n* MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria\n* Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide\n* Participants must have measurable disease during screening\n\nExclusion Criteria:\n\n* Known history of systemic light chain amyloidosis with major organ involvement (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)\n* Known history or current plasma cell leukemia\n* GI disease that might significantly alter absorption of oral drugs\n* Participants must not have any ongoing CNS disease or non-secretory myeloma","locations":[{"facility":"City of Hope National Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope - 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below.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Minimal Residual Disease (MRD)-Negative Complete Response (CR) Rate","Progression-Free Survival 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3: testing Cevostamab for Multiple Myeloma","inPlainEnglish":"This study wants to assess the how well it works and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to start of administration of study treatment","Individuals with how well you can do daily activities (ECOG score) of 2 solely due to local symptoms of myeloma (e.g., pain) are eligible","MM diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria","Received one to three lines of prior therapy that included at least two consecutive cycles of either of the following: A regimen containing an anti-CD38 therapy, a regimen containing lenalidomide","Participants must have measurable disease during screening"],"whoShouldSkip":["Known history of systemic light chain amyloidosis with major organ involvement (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)","Known history or current plasma cell leukemia","GI disease that might significantly alter absorption of oral drugs","Participants must not have any ongoing CNS disease or non-secretory myeloma"],"whatHappens":"If you join, the listed intervention(s) are Cevostamab, Pomalidomide, or Dexamethasone. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) versus standard of care (SOC) in participants with multiple myeloma (MM) who have received one to three prior lines of therapy and have been exposed to an anti-CD38 monoclonal antibody (mAb) and lenalidomide.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 380 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.480Z"},{"nctId":"NCT07556159","title":"A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice","officialTitle":"A Hybrid Cross-sectional and Prospective Study to Assess Patient Characteristics, Disease Burden, Disease Control, Phenotypes, Endotypes, and Outcomes in a Real-world Setting in Patients With Asthma","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life.\n\nThe study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.","conditions":["Asthma"],"keywords":["Cross-Sectional","Multicenter","Inhaled Corticosteroids"],"interventions":[{"type":"OTHER","name":"Procedure: Investigational Procedures"},{"type":"OTHER","name":"Procedure: Investigational Procedures"}],"enrollment":2500,"startDate":"2026-04-01","completionDate":"2029-04-04","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nApplicable for Part 1 participants:\n\n* Age 6 years and older, at the time of signing the informed consent\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n\nApplicable for Part 2 participants:\n\n* Age 18 years and older, at the time of signing the informed consent.\n* Physician diagnosis of asthma for at least 12 months\n* Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps\n* Participant or legally authorized representative (where applicable) has consented to participate\n* Participants must meet the criteria for at least one of the cohorts below:\n\nA) Asthma control cohorts\n\n1. ACQ-5 \\>= 1.5\n2. ACQ-5 \\< 1.5 (B) Type-2 biomarker cohorts\n3. Elevated T2 biomarkers (B1: Type-2-high cohort)\n4. Low T2 biomarkers (B2: Type-2-low cohort)\n\nParticipants are excluded from the study if any of the following criteria apply (applicable for both Part 1 and Part 2 participants):\n\n* Current diagnosis of chronic obstructive pulmonary disease (COPD) or congestive heart failure\n* Participants with moderate/severe cognitive impairment.\n* Participants with moderate/severe cardiac disease.\n* Participants on immunosuppressive medication for a chronic condition.\n* Participation in other interventional and noninterventional clinical study (currently or in the past 3 months)\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","locations":[{"facility":"Trinity Clinical Research, LLC - Bessemer - Site Number: 840150","city":"Bessemer","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chandler Clinical Trials - Site Number: 840106","city":"Chandler","state":"Arizona","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC - 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Miami Lakes - Site Number: 840146","city":"Miami Lakes","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Deluxe Health Center - Site Number: 840117","city":"Miami Lakes","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"MedQuest Translation Sciences, LLC - Site Number: 840162","city":"Miami Lakes","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Biscayne Clinical Research - Site Number: 840157","city":"North Miami Beach","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CTMD Research, Inc - Site Number: 840147","city":"Palm Springs","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Edward Jenner Research Group, LLC - Site Number: 840169","city":"Plantation","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mark J. Pamer D.O., LLC - Site Number: 840121","city":"Port Saint Lucie","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"TBC Research Corp - Site Number: 840132","city":"Tamarac","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Avita Clinical Research - Tampa - Site Number: 840125","city":"Tampa","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Palm Beach Medical & Research Center, Inc. - Site Number: 840165","city":"West Palm Beach","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"The Allergy Center at Brookstone - Site Number: 840114","city":"Columbus","state":"Georgia","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Next Innovation Clinical Research - Chicago - Site Number: 840159","city":"Chicago","state":"Illinois","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Bluegrass Allergy Care - Lexington - Site Number:840112","city":"Lexington","state":"Kentucky","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Columbia Medical Practice - Site Number: 840172","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Rockville - Site Number: 840163","city":"Rockville","state":"Maryland","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan - Ann Arbor - Site Number: 840140","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montana Medical Research - Site Number: 840137","city":"Missoula","state":"Montana","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Primary Clinical Research, LLC - Papillion - Site Number: 840168","city":"Papillion","state":"Nebraska","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"MedCorps Asthma and Pulmonary Specialists LLC - Sewell - Site Number: 840136","city":"Sewell","state":"New Jersey","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Finger Lakes Medical Research, PLLC - Site Number: 840155","city":"Cortland","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Mid Hudson Medical Research, PLLC - Site Number: 840139","city":"New Windsor","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai - Center for Advanced Medicine - Site Number: 840119","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Allergy Partners of Western North Carolina - Site Number: 840131","city":"Asheville","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Gastonia (CRG) - Site Number: 840160","city":"Gastonia","state":"North Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"East Carolina University Physicians - Pulmonary and Critical Care Medicine - Site Number: 840142","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NexGen Research - Site Number: 840154","city":"Lima","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Toledo Institute of Clinical Research Inc - Site Number: 840105","city":"Toledo","state":"Ohio","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Allergy and Clinical Immunology Associates - Site Number: 840127","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Rock Hill - Site Number: 840115","city":"Rock Hill","state":"South Carolina","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Allergy Associates, PA dba Allergy, Asthma and Sinus Center - Site Number: 840144","city":"Tennessee City","state":"Tennessee","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Southwest Family Medicine Associates - Site Number: 840126","city":"Dallas","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"El Paso Pulmonary Association (EPPA) - West El Paso - Site Number: 840108","city":"El Paso","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Lumi Research - Site Number: 840156","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Pioneer Research Solutions - Site Number: 840104","city":"Houston","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Lumi Research - Hurst - Site Number: 840164","city":"Hurst","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical - Tomball - Site Number: 840130","city":"Tomball","state":"Texas","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Bellingham Asthma, Allergy & Immunology Clinic - Site Number: 840138","city":"Bellingham","state":"Washington","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 124203","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 124201","city":"Windsor","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 124204","city":"Trois-Rivières","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250603","city":"Brest","state":"Brittany Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250612","city":"Lunel","state":"Occitanie","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250607","city":"Toulouse","state":"Occitanie","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250613","city":"La Roche-sur-Yon","state":"Pays de la Loire Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250616","city":"Argenteuil","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 250609","city":"Créteil","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 276503","city":"München","state":"Bayern (Bavaria)","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 276505","city":"Bonn","state":"North Rhine-Westphalia","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 276501","city":"Hohenstein-Ernstthal","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 276502","city":"Schleswig","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392705","city":"Kitakyushu-Shi","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392702","city":"Takamatsu","state":"Kagawa-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392711","city":"Saga","state":"Saga-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392710","city":"Bunkyo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392709","city":"tabashi City","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 392707","city":"Niigata","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number: 724408","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended-Toll free for US & Canada","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Part 1: Descriptive Characterization of Participants With Asthma Across the Spectrum of Severities","Part 1: ACQ-5 Scores to Evaluate Characteristics of Participants With Asthma","Part 1: Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ) Scores to Evaluate Characteristics of Participants With Asthma","Part 1: Physician Global Assessment of Asthma Severity and Symptom Control","Part 2: Descriptive Statistical Analysis of Difference in Asthma Symptom Control (ACQ-5) Between Part 2 Cohorts A1 and A2","Part 2: Number of Participants Analyzed with Treatment Utilization Pattern between Part 2 Cohorts A1 and A2","Part 2: Descriptive Statistical Analysis of Difference in Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (Pre-BD FEV₁) between Part 2 Cohorts B1 and Cohort B2"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["bessemer-alabama","chandler-arizona","mesa-arizona","scottsdale-arizona","sun-city-arizona","california-city-california","la-palma-california","los-angeles-california","newport-beach-california","pasadena-california","tarzana-california","walnut-creek-california","altamonte-springs-florida","boca-raton-florida","brandon-florida","greenacres-city-florida","miami-florida","miami-gardens-florida","miami-lakes-florida","north-miami-beach-florida","palm-springs-florida","plantation-florida","port-saint-lucie-florida","tamarac-florida","tampa-florida","west-palm-beach-florida","columbus-georgia","chicago-illinois","lexington-kentucky","columbia-maryland","rockville-maryland","ann-arbor-michigan","missoula-montana","papillion-nebraska","sewell-new-jersey","cortland-new-york","new-windsor-new-york","new-york-new-york","asheville-north-carolina","gastonia-north-carolina","greenville-north-carolina","lima-ohio","toledo-ohio","pittsburgh-pennsylvania","rock-hill-south-carolina","tennessee-city-tennessee","dallas-texas","el-paso-texas","houston-texas","hurst-texas","tomball-texas","bellingham-washington","calgary-canada","windsor-canada","trois-rivi-res-canada","brest-france","lunel-france","toulouse-france","la-roche-sur-yon-france","argenteuil-france","cr-teil-france","m-nchen-germany","bonn-germany","hohenstein-ernstthal-germany","schleswig-germany","kitakyushu-shi-japan","takamatsu-japan","saga-japan","bunkyo-ku-japan","tabashi-city-japan","niigata-japan","madrid-spain"],"enrichment":{"headline":"Not a traditional drug phase: Procedure: Investigational Procedures for Asthma","inPlainEnglish":"The main aim of the study to describe the characteristics of participants with asthma across the spectrum of disease severity, including sociodemographic and clinical characteristics, treatment and disease burden, biomarkers, and both disease-specific and generic health-related quality of life. The study consists of two parts: a cross-sectional study, and a prospective follow-up evaluate changes in disease trajectories in participants with asthma.","whoItsFor":["Ages 6 Years to any","Applicable for Part 1 participants:","Physician diagnosis of asthma for at least 12 months","Existing treatment with low, medium, or high dose ICS and other asthma therapies as reflected in GINA 2-5 steps","Participant or legally authorized representative (where applicable) has consented to participate","Applicable for Part 2 participants:","Existing treatment with low or medium ICS and other asthma therapies as reflected in GINA 2-4 steps","Participants must meet the criteria for at least one of the cohorts below:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,500 people at 83 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.346Z"},{"nctId":"NCT07557121","title":"Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration","officialTitle":"A Phase 2, Multicenter, Randomized, Active-controlled Trial of the Safety and Efficacy of AIV007 by Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"AiViva BioPharma, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile.\n\nParticipants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.","conditions":["Neovascular (Wet) Age-Related Macular Degeneration"],"keywords":["wet AMD","anti-VEGF","periocular","Eylea","tyrosine kinase inhibitor"],"interventions":[{"type":"DRUG","name":"AIV007"},{"type":"BIOLOGICAL","name":"EYLEA® (aflibercept) Injection 2 mg (0.05mL)"}],"enrollment":35,"startDate":"2026-07-01","completionDate":"2027-06-30","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Previously treated neovascular (wet) age-related macular degeneration (nAMD)\n* Responsive to prior intravitreal anti-VEGF therapy\n* Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent)\n* Active choroidal neovascularization lesion in the study eye secondary to nAMD.\n* Central subfield thickness in the study eye of less than or equal to 370 microns.\n* Compliance to all study protocol requirements\n\nExclusion Criteria:\n\n* Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy\n* History of uncontrolled intraocular pressure\n* Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye\n* History of vitreoretinal surgery, corneal transplant, glaucoma surgery in the study eye or cataract surgery within 3 months before screening visit\n* History of vitreous hemorrhage within 3 months prior to screening visit in the study eye\n* A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye\n* Anterior chamber intraocular lens, aphakia, or violation of the posterior capsule in the study eye; prior Nd:YAG laser posterior capsulotomy in association with posterior intraocular lens implantation is allowed provided it occurred at least 30 days before the screening visit\n* Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye\n* Intraretinal fluid (IRF) in the proposed study eye of less than 30 µm confirmed by the CRC following the screening visit","locations":[{"facility":"Macula and Vitreous Center","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Retina Institute, P.A.","city":"McAllen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Darlene C. Deecher, phd","phone":"2674544560","email":"darlene@aiviva.com"},{"name":"Diane DS Tang-Liu, PHD","phone":"7023371797","email":"diane@aiviva.com"}],"primaryOutcomes":["Best-corrected Visual Acuity"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["torrance-california","mcallen-texas"],"enrichment":{"headline":"Phase 2: testing AIV007 for Neovascular (Wet) Age-Related Macular Degeneration","inPlainEnglish":"The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile. Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and how well it works observations and/or continued treatment.","whoItsFor":["Ages 50 Years to 85 Years","Previously treated neovascular (wet) age-related macular degeneration (nAMD)","Responsive to prior intravitreal anti-VEGF therapy","Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent)","Active choroidal neovascularization lesion in the study eye secondary to nAMD","Central subfield thickness in the study eye of less than or equal to 370 microns","Compliance to all study protocol requirements"],"whoShouldSkip":["Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy","History of uncontrolled intraocular pressure","Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye","History of vitreoretinal surgery, corneal transplant, glaucoma surgery in the study eye or cataract surgery within 3 months before screening visit","History of vitreous hemorrhage within 3 months prior to screening visit in the study eye","A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye","Anterior chamber intraocular lens, aphakia, or violation of the posterior capsule in the study eye; prior Nd:YAG laser posterior capsulotomy in association with posterior intraocular lens implantation is allowed provided it occurred at least 30 days before the screening visit"],"whatHappens":"If you join, the listed intervention(s) are AIV007, or EYLEA® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.141Z"},{"nctId":"NCT07557914","title":"Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes","officialTitle":"A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Haibo Shao","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.","conditions":["HCC - Hepatocellular Carcinoma","Diabetes"],"keywords":["hepatic arterial infusion chemotherapy","Donafenib","Tislelizumab","HCC - Hepatocellular Carcinoma","Diabetes"],"interventions":[{"type":"DRUG","name":"Epalrestat"},{"type":"DRUG","name":"Donafenib + Tislelizumab"},{"type":"PROCEDURE","name":"HAIC"}],"enrollment":32,"startDate":"2026-01-21","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);\n2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;\n3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;\n4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;\n\nExclusion Criteria:\n\n1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;\n2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);\n3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;\n4. Renal failure: Creatinine clearance rate \\< 30 mL/min;\n5. Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);\n6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \\> 2000 IU/mL);\n7. ECOG PS ≥ 2 or extremely poor overall condition;\n8. Diabetic patients with acute ketoacidosis or during the period of severe infection;\n9. Pregnant and lactating women;\n10. Known history of other malignancy.","locations":[{"facility":"Harbin Medical University Cancer Hospital","city":"Harbin","state":"Heilongjiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yanbian University Hospital","city":"Yanji","state":"Jilin","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of China Medical University","city":"Shenyang","state":"Liaoning","country":"China","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Liaoning Cancer Hospital","city":"Shenyang","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hongbin Zou","phone":"+8618040026871","email":"hongbinzou300@gmail.com"}],"primaryOutcomes":["12-month Event-free survival (EFS) Rate"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["harbin-china","yanji-china","shenyang-china"],"enrichment":{"headline":"Phase 2: testing Epalrestat for HCC - Hepatocellular Carcinoma","inPlainEnglish":"This study wants to measure the comprehensive therapeutic how well it works and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.","whoItsFor":["Ages 18 Years to 80 Years","Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);","Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;","Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;","Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;"],"whoShouldSkip":["Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;","Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);","Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;","Renal failure: Creatinine clearance rate \\< 30 mL/min;","Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);","Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \\> 2000 IU/mL);","ECOG PS ≥ 2 or extremely poor overall condition;"],"whatHappens":"If you join, the listed intervention(s) are Epalrestat, Donafenib + Tislelizumab, or HAIC. The registry lists allocation as na. This study wants to measure the comprehensive therapeutic how well it works and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.620Z"},{"nctId":"NCT07558265","title":"WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department","officialTitle":"WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ohio State University","sponsorClass":"OTHER","summary":"The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support. Participants will be randomly assigned (with an equal chance) to receive one of the following treatments:\n\n* Non-Invasive Positive Pressure Ventilation (NIPPV): Oxygen delivered under pressure through a face mask.\n* High-Flow Nasal Oxygen (HFNO): Oxygen delivered at high-flow through a specially designed nasal cannula placed in the nostrils.\n\nResearchers will compare the two treatment strategies using a hierarchical assessment of major pulmonary outcomes, including:\n\n* Hospital survival\n* Days on mechanical ventilation\n* Duration of non-invasive respiratory support\n\nAs part of the study, researchers will collect:\n\n* Blood and urine samples\n* Physiologic measurements (such as chest movement measured through sensors placed on the skin)\n* Information from participants' medical records","conditions":["Acute Hypoxic Respiratory Failure","Acute Respiratory Distress Syndrome (ARDS)"],"keywords":["Acute Hypoxemic Respiratory Failure","Acute Decompensated Heart Failure","Acute Respiratory Distress Syndrome","BiPAP","BPAP","COPD","Chronic Obstructive Pulmonary Disease","Continuous Positive Airway Pressure","HFNO","High-Flow Nasal Oxygen","EPAP","Expiratory Positive Airway Pressure","FiO2","Inspired Oxygen Fraction","IMV","Invasive Mechanical Ventilation","IPAP","Inspiratory Positive Airway Pressure","MAPE","Major Adverse Pulmonary Events","MV","Mechanical Ventilation","NIRS","Non-Invasive Respiratory Support","NIPPV","Non-Invasive Positive Pressure Ventilation","PaCO2","Partial pressure of carbon dioxide in arterial blood","PaO2","Partial pressure of oxygen in arterial blood","P:F","Ratio of PaO2 to FiO2","RR","Respiratory Rate","P-SILI","Patient Self-Inflicted Lung Injury","RRT","Renal Replacement Therapy","RSFD","Respiratory Support Free Days","S:F","Ratio of SpO2 to FiO2","SpO2","Transcutaneous measurement of peripheral arterial saturation","UADE","Unanticipated Adverse Device Effects","VAS","Visual Analog Scale","VDays","Ventilator Days","VFD","Ventilator-Free Days","WINDSURFER","WIN ratio analysis to determine a strategy of non-invasive support for respiratory failure in the emergency department trial","WR","WIN Ratio","Bilevel Positive Airway Pressure"],"interventions":[{"type":"DEVICE","name":"Non-Invasive Positive Pressure Ventilation"},{"type":"DEVICE","name":"High Flow Nasal Oxygen"}],"enrollment":500,"startDate":"2026-08-18","completionDate":"2031-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as:\n\n  * \\[(respiratory rate ≥25 breaths/min) AND (requiring ≥6 L/min of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\\<250\\] OR\n  * Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS).\n* Clinical need for NIRS\n* Randomization ≤2 hours after identification of need for NIRS\n* Randomization ≤6 hours of ED arrival\n\nExclusion Criteria:\n\n* Urgent need for intubation\n* Cardiac arrest\n* Respiratory arrest\n* Patient not located in the ED\n* Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface\n* Tracheostomy or laryngectomy stoma\n* Hemodynamic instability requiring \\>0.2mcg/kg/min of norepinepherine (or equivalent) to maintain mean arterial pressure \\>65mmHg\n* Pre-existing \"do not resuscitate\" or \"do not intubate\" order\n* Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea\n* Transferred from another Emergency Department\n* History of advanced chronic obstructive pulmonary disease\n* History of advanced heart failure\n* Presence of opt-out identification\n* Prisoner\n* Known or apparent pregnant\n* Previous enrollment in WINDSURFER\n* A patient-specific contraindication makes one assigned study intervention unsafe","locations":[{"facility":"Banner University Medical Center Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale New Haven Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan Medical Center","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wake Forest Baptist Medical Center","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State East Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSU Wexner Medical Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Temple University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Medical Center","city":"Murray","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harborview Medical Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Henry E Wang, MD, MS","phone":"614-648-1372","email":"Henry.wang@osumc.edu"},{"name":"Valerie L Durkalski-Mauldin, PhD","phone":"843-876-1911","email":"durkalsv@musc.edu"}],"primaryOutcomes":["Number of Subjects with Major Adverse Pulmonary Event (MAPE)"],"hasResults":false,"conditionSlugs":["heart-failure","copd"],"drugSlugs":[],"locationSlugs":["tucson-arizona","new-haven-connecticut","ann-arbor-michigan","winston-salem-north-carolina","columbus-ohio","philadelphia-pennsylvania","murray-utah","seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: Non-Invasive Positive Pressure Ventilation for Acute Hypoxic Respiratory Failure","inPlainEnglish":"The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment. This study compares two commonly used non-invasive respiratory support strategies to evaluate their effectiveness and safety, based on important patient outcomes during hospitalization, including survival, the need for invasive mechanical ventilation, and the duration of respiratory support.","whoItsFor":["Ages 18 Years to any","Presenting to the Emergency Department (ED) with Acute Hypoxemic Respiratory failure (AHRF), defined as:","\\[(respiratory rate ≥25 breaths/min) AND (requiring ≥6 L/min of oxygen required to maintain SpO2 ≥90%), OR SpO2:FiO2 ratio\\<250\\] OR","Arrival at ED on prehospital Non-Invasive Respiratory Support (NIRS)","Clinical need for NIRS","Randomization ≤2 hours after identification of need for NIRS","Randomization ≤6 hours of ED arrival"],"whoShouldSkip":["Urgent need for intubation","Patient not located in the ED","Craniofacial anatomic features that prohibit either Non-Invasive Positive Pressure Ventilation (NIPPV) or High Flow Nasal Oxygen (HFNO) interface","Tracheostomy or laryngectomy stoma","Hemodynamic instability requiring \\>0.2mcg/kg/min of norepinepherine (or equivalent) to maintain mean arterial pressure \\>65mmHg","Pre-existing \"do not resuscitate\" or \"do not intubate\" order","Home use of non-invasive positive-pressure ventilation for respiratory support of a medical condition other than sleep apnea"],"whatHappens":"If you join, the listed intervention(s) are Non-Invasive Positive Pressure Ventilation, or High Flow Nasal Oxygen. The registry lists allocation as randomized. The purpose of this clinical trial is to determine the best initial non-invasive respiratory support (NIRS) strategy for adults who present to the emergency department with acute hypoxemic respiratory failure, a condition in which blood oxygen levels are dangerously low and require urgent treatment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 500 people at 9 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.499Z"},{"nctId":"NCT07558733","title":"Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer","officialTitle":"Open-Label Umbrella Study to Evaluate Safety and Efficacy of Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Faeth Therapeutics","sponsorClass":"INDUSTRY","summary":"The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.","conditions":["HR+ HER2- Breast Cancer"],"keywords":["Serabelisib","Sapanisertib","Fulvestrant","Palbociclib","PI3K","mTOR","Dual PI3K/mTOR inhibition","Genetic Mutation","Faslodex","SERDs","Select Estrogen Receptor Degraders","CDK","CDK46","CDK4-6","HER2-","HER2 negative","HR+","HR positive","Hormone Receptor Positive","Advanced Breast Cancer","Metastatic Breast Cancer","Recurrent Breast Cancer","Breast Cancer","Cancer of the breast","Carcinoma of the breast","Neoplasms, Breast","Metabolism","Synthetic Lethality","Metabolism Programming","PIK3CA","Oral Medications","Antineoplastic agents","AKT"],"interventions":[{"type":"DRUG","name":"Serabelisib"},{"type":"DRUG","name":"Sapanisertib"},{"type":"DRUG","name":"Fulvestrant"}],"enrollment":32,"startDate":"2026-04-22","completionDate":"2029-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically confirmed diagnosis of HR+/HER2- breast cancer.\n* Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent.\n* Participant has received at least one prior systemic therapy.\n* At least 1 measurable or evaluable target lesion according to RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening.\n* Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods.\n\nExclusion Criteria:\n\n* Participants with triple-negative breast cancer.\n* Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study.\n* Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible.\n* Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment.\n* Significant cardiovascular impairment.\n* Active, uncontrolled infection.\n* Concurrent participation in another therapeutic clinical trial.\n* Prior radiation therapy within 21 days prior to start of study treatment.\n* Participants who have received a prior PI3K, AKT, mTORC1/2, or dual PI3K/mTOR inhibitor.\n* Strong CYP3A4 inhibitors, strong CYP1A2 inhibitors or CYP1A2 inducers, or clinically significant CYP3A4 inducers within 7 days before the first dose of study intervention, or participants who require treatment with strong CYP3A4 inhibitors or inducers during the study.\n* Prolongation of QTc interval to \\>480 ms.\n* Type 1 or Type 2 diabetes mellitus on insulin.","locations":[{"facility":"START Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates of Oregon","city":"Springfield","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Central/South","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - San Aantonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Medical Monitor","phone":"(708) 406-9282","email":"clinicaltrials@faeththerapeutics.com"}],"primaryOutcomes":["Safety and tolerability of drugs by assessment of adverse events (AEs) / serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["palbociclib"],"locationSlugs":["los-angeles-california","lone-tree-colorado","springfield-oregon","nashville-tennessee","austin-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Serabelisib for HR+ HER2- Breast Cancer","inPlainEnglish":"The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary how well it works of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.","whoItsFor":["Ages 18 Years to any","Histologically confirmed diagnosis of HR+/HER2- breast cancer","Documented evidence of advanced or recurrent disease that is not amenable to surgery/radiation for curative intent","Participant has received at least one prior systemic therapy","At least 1 measurable or evaluable target lesion according to RECIST v1.1","Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 at Screening","Non-pregnant, non-lactating females who are postmenopausal, surgically sterile or who agree to use effective contraceptive methods"],"whoShouldSkip":["Participants with triple-negative breast cancer","Participants with central nervous system metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study","Active malignancy (except for breast cancer, definitively treated in-situ carcinomas \\[e.g., breast, cervix, bladder\\], or basal or squamous cell carcinoma of the skin) within the past 24 months prior to treatment. Fully resected localized malignancies are eligible","Gastric feeding tube (gastrostomy tube), gastrointestinal malabsorption, gastrointestinal anastomosis, bowel obstruction, or any other condition that might affect the absorption of study treatment","Significant cardiovascular impairment","Active, uncontrolled infection","Concurrent participation in another therapeutic clinical trial"],"whatHappens":"If you join, the listed intervention(s) are Serabelisib, Sapanisertib, or Fulvestrant. The registry lists allocation as randomized. The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary how well it works of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 32 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.732Z"},{"nctId":"NCT07558915","title":"A Study to Evaluate RO7851624 in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)","officialTitle":"An Open-Label, Multicenter, Phase Ia/b Study Evaluating the Safety and Pharmacokinetics of RO7851624 in Patients With Relapsed/Refractory Multiple Myeloma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \\[PIs\\], immunomodulators \\[IMiDs\\], and anti-cluster of differentiation 38 \\[anti-CD38\\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.","conditions":["Relapsed/Refractory Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7851624"}],"enrollment":160,"startDate":"2026-06-23","completionDate":"2030-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Life expectancy of at least 12 weeks.\n* Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria.\n* Measurable disease.\n\nExclusion Criteria:\n\n* Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment.\n* Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment.\n* Prior allogeneic SCT.\n* Prior solid organ transplantation.","locations":[{"facility":"Peter MacCallum Cancer Center","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Gangnam-gu","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: GO46140 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["parkville-australia","gangnam-gu-south-korea"],"enrichment":{"headline":"Phase 1: testing RO7851624 for Relapsed/Refractory Multiple Myeloma","inPlainEnglish":"This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \\[PIs\\], immunomodulators \\[IMiDs\\], and anti-cluster of differentiation 38 \\[anti-CD38\\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1","Life expectancy of at least 12 weeks","Diagnosis of multiple myeloma per International Myeloma Working Group (IMWG) criteria","Measurable disease"],"whoShouldSkip":["Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) with insufficient washout prior to first dose of study treatment","Autologous stem cell transplant (SCT) with insufficient time prior to first dose of study treatment","Prior allogeneic SCT","Prior solid organ transplantation"],"whatHappens":"If you join, the listed intervention(s) are RO7851624. The registry lists allocation as na. This study will evaluate safety, pharmacokinetics (PK), clinical activity and pharmacodynamics (PD) of RO7851624 in participants with RRMM who are triple-class exposed (treated with proteasome inhibitors \\[PIs\\], immunomodulators \\[IMiDs\\], and anti-cluster of differentiation 38 \\[anti-CD38\\] monoclonal antibodies), and have limited remaining standard treatment options due to refractoriness, intolerance, or multiple prior therapies.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 160 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.483Z"},{"nctId":"NCT07559500","title":"Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD)","officialTitle":"Tirzepatide s Dopaminergic Effects in Alcohol Use Disorders (AUD), a Phase 1b Study","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)","sponsorClass":"NIH","summary":"Background:\n\nGlucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol. Researchers want to know if a GLP-1 drug (tirzepatide) can lessen the urge to drink in people with alcohol use disorder (AUD).\n\nObjective:\n\nTo learn how the brains of people with AUD respond to a GLP-1 drug.\n\nEligibility:\n\nPeople aged 21 to 65 years with AUD who are non-treatment seeking. They must be enrolled in protocol 14-AA-0181. Healthy volunteers are also needed.\n\nDesign:\n\nThis study consists of Part 1 and Part 2.\n\nPart 1 (Imaging Procedures): Five healthy volunteers will undergo 2 to 3 combined positron emission tomography/magnetic resonance imaging (PET/MRI) scans, with an interval of 2 to 3 weeks between scans. For each scan, a radioactive substance (tracer) will be administered intravenously. Participants will undergo PET/MRI scanning to assess brain activity during resting state. Methylphenidate (Ritalin) will be administered during each scan. Each imaging session will last approximately 2 hours. Tirzepatide and placebo will not be administered in Part 1. Participants with alcohol use disorder (AUD) are not included in Part 1. The purpose of this part of the study is to assess test/retest reproducibility of the PET/MRI combined scan measures.\n\nPart 2 (Randomization to Tirzepatide \\& Placebo): Participants will be randomized to receive either Tirzepatide or Placebo first. Healthy Volunteers and AUD participants will receive both treatments in a crossover design. Tirzepatide and placebo will be administered via subcutaneous injection (under the skin) once weekly for 2 to 3 weeks. This treatment period will be followed by 2 to 3 PET/MRI combined imaging scans described in the next paragraph. After a washout interval of approximately 2 to 3 weeks, participants will cross over to the alternate treatment (tirzepatide or placebo), administered once weekly for 2 to 3 weeks. This second treatment period will be followed by an additional 2 to 3 PET/MRI scans. Participants may receive up to 3 doses of tirzepatide and 3 doses of placebo.\n\nPart 2 (Imaging Procedures): Healthy Volunteers and participants with an AUD will undergo PET/MRI scans at two time points: following tirzepatide administration and following placebo administration. For each scan a radioactive substance (tracer) will be administered intravenously. Brain activity will be measured during PET/MRI acquisition during resting state. Methylphenidate will be administered during 1 of the scans at each time point. Each imaging session will last approximately 2 hours. Participants will wear a device to track their activity for at least 1 week before each set of scans. They will have tests of their thinking, memory, and attention.","conditions":["Alcohol Use Disorder (AUD)"],"keywords":["Tirzepatide","Dopamine","Alcohol Use Disorder (AUD)","Normal Physiology","GLP-1"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"[11C]raclopride plus drug"},{"type":"DRUG","name":"[11C]NNC-112"}],"enrollment":176,"startDate":"2026-05-20","completionDate":"2031-12-31","sex":"ALL","minAge":"21 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nHealthy Volunteer Participants\n\nTo be eligible to participate in this study, an individual must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n\nAUD Participants\n\nTo be eligible, individuals with AUD must meet the following criteria:\n\n1. Enrollment in 14AA0181.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. Male or female, ages 21-65 years old.\n4. Ability to understand and willingness to sign a written informed consent document.\n5. DSM 5 diagnosis of mild to moderate AUD.\n6. Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder.\n7. Minimum 2-year history of heavy drinking (SAMSHA s criteria for heavy drinking: for men 5 or more drinks/day on at least 5 different days per month; and for women 4 or more\n\n   drinks/day on at least 5 different days per month.\n8. Non treatment seeking AUD participants.\n\nEXCLUSION CRITERIA:\n\nAll Participants (Healthy Volunteers and AUD)\n\n1. Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI\n2. Cannot lie comfortably flat on his/her back for up to 2 hours in the PET/MRI scanner.\n3. BMI \\<23 or \\>35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs.\n4. Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam.\n5. Pregnant or breast-feeding: Females of childbearing potential, or with tubal ligation, or are post-menopausal and are age 55 or less will undergo a urine pregnancy test and it must be negative to continue participation. Urine pregnancy tests will be repeated on subsequent days of study (i.e., within 24 hours before study procedures). Females must not be currently breastfeeding.\n6. Women using oral contraceptives (Part 2 of study). Women of childbearing age who are taking oral contraceptives will be required to switch to a non-oral hormonal contraceptive method (ie implants, injections, or IUDs) or add a barrier method (condoms) for the duration of the study and for 4 weeks after the last dose of study drug after explaining to them that Tirzepatide could make contraceptive less effective. We will not provide nonoral contraceptive medications to participants.\n7. Severe head trauma with loss of consciousness \\> 60 minutes\n8. Current severe mental illness (schizophrenia, bipolar disorder).\n9. Montgomery-Asberg depression rating scale (MADRS) total score \\> 35 or suicidal thoughts item score \\> 3, indicating severe depression or moderate suicidality, respectively.\n10. Thyroid cancer or family history of thyroid cancer or personal or family history of multiple endocrine neoplasia syndrome type-2 (MEN-2).\n11. History for cerebral aneurysm.\n12. Past or present history of chest pain and trouble breathing with activity.\n13. History of Heart Disease, Hypertension or Cardiovascular disorders.\n14. History of seizures, anxiety, panic attacks, psychosis or glaucoma which are contraindicated with receiving methylphenidate.\n15. History of gallbladder disease, pancreatitis, gastroparesis, diabetic retinopathy, acute kidney injury (AKI), as these are contraindicated for Tirzepatide.\n16. History of allergic reaction to methylphenidate, Tirzepatide or allergic reactions to dyes or preservatives.\n17. Major medical problems that can permanently impact brain function (e.g., seizures, psychosis, stroke, Alzheimer s disease, Parkinson s disease, traumatic brain injury with\n\n    loss of consciousness \\> 30 minutes, clinically significant arrhythmias except bradycardia, and HIV+).\n18. Clinically significant laboratory findings that could impact brain function or study procedures (e.g., active infections, significant EKG results, hepatic or renal failure) will be\n\n    exclusionary.\n19. Current DSM-5 diagnosis of a psychiatric disorder that required daily psychoactive medications (antidepressant, antipsychotics, stimulants, opioids, benzodiazepines or barbiturates) in the past two months and that could impact brain function at the time of the study as determined by history and clinical exam.\n20. History of moderate or severe SUD (other than nicotine in HV s, and nicotine, cannabis or alcohol for AUD participants).\n21. Daily current use (past 2 months) of the following drugs/medications are exclusionary: stimulant or stimulant-like drugs or medications (cocaine, methamphetamine, amphetamine, methylphenidate, modafinil); opioid drugs or medications; other GLP-1 or anti-diabetic drugs (e.g., insulin, sulfonylureas) medications, antianginal agents; antiarrhythmics; systemic corticosteroids; anticholinergics; anticoagulants; anticonvulsants; antidepressants with dopaminergic effects (bupropion, sertraline, and dopamine agonists like pramipexole and ropinirole); beta-blocker antihypertensives; antineoplastics; antipsychotics; anxiolytics (benzodiazepine or barbiturates); or lithium. Note that alcohol and cannabis use are not exclusionary but participants cannot be intoxicated on the day of study as evidence of alcohol in breathalyzer or cannabis in saliva. Caffeine and nicotine are permitted but participants will be asked to refrain from consuming caffeine or nicotine products (including cigarettes) two hours prior to the study. Antihistamines are also not exclusionary but should not be used on the day of study.\n22. \\*Non-English speakers (must also be able to read and comprehend English\n\n    * We are excluding non-English speakers since the study includes questionnaires that are validated for English and only some are available in Spanish. The fMRI paradigms also require that the subject be able to speak, read and comprehend English.\n\nNote that subjects will not be excluded from enrollment onto this study if their urine test or breath alcohol level (BAL) is positive for alcohol/drugs on initial screening. The following guidelines will be followed for positive drug/alcohol screens on study procedure days involving imaging scans and neuropsychological testing for all participants:\n\n* If a subject s breath alcohol (\\>0.08%) screen test is positive on days involving imaging (PET/MRI) and NP testing, the procedures will be postponed and rescheduled. We will allow for up to 3 rescheduled study days resulting from positive breath alcohol screens. If subject continues to show up intoxicated they will be withdrawn.\n* If urine drug screen is positive for THC-COOH a saliva drug screen will be performed and subject may proceed with study day testing procedures if saliva results for THC are negative. If we are unable to perform the saliva drug screen for any reason, the study day procedures will be postponed. If the urine/saliva drug test is positive on the third rescheduled visit, the participant will be withdrawn from the study. Saliva THC is not required for determining eligibility.\n* If a participants urine drug screen test is positive for cocaine, heroin or methamphetamine after 3 days of rescheduling they will be excluded.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michele-Vera I Yonga, C.R.N.P.","phone":"(301) 273-4169","email":"michele-vera.yonga@nih.gov"},{"name":"Nora D Volkow Adler, M.D.","phone":"(301) 443-6480","email":"nvolkow@nida.nih.gov"}],"primaryOutcomes":["Part 1 (n=5 healthy volunteers): We will assess the reproducibility of striatal dopamine (DA) measures in response to iv methylphenidate (MP) using PET/MR combined scanning and the bolus infusion protocol in healthy controls.","Part 2 (n=88, 44 healthy volunteers and 44 AUD) : Effects of Tirzepatide on striatal dopamine D1R and D2R availability; striatal DA increase; brain reactivity to MP and to food and alcohol cues in AUD and in healthy controls."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["tirzepatide"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing Tirzepatide for Alcohol Use Disorder (AUD)","inPlainEnglish":"Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss. They may also help reduce cravings for drugs and alcohol.","whoItsFor":["Ages 21 Years to 65 Years","Healthy Volunteer Participants","To be eligible to participate in this study, an individual must meet the following criteria:","Enrollment in 14AA0181","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, ages 21-65 years old","Have or had any prior experience with stimulant drugs including cocaine, methylphenidate, amphetamine or methamphetamine, or prescription stimulants (prescription or recreational use), whether or not they have had a past substance use disorder","To be eligible, individuals with AUD must meet the following criteria:"],"whoShouldSkip":["All Participants (Healthy Volunteers and AUD)","Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI","Cannot lie comfortably flat on his/her back for up to 2 hours in the PET/MRI scanner","body-mass index (BMI) \\<23 or \\>35 (but no more than 500 lbs). The PET/MRI scanner bed is tested to a weight limit of 500 lbs","Have had previous radiation exposure (from X-rays, PET scans, or other exposure) that, with the exposure from this study, would exceed NIH annual research limits as determined by medical history and physical exam","Severe head trauma with loss of consciousness \\> 60 minutes","Current severe mental illness (schizophrenia, bipolar disorder)"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, Placebo, or [11C]raclopride plus drug. The registry lists allocation as randomized. Background: Glucagon-like peptide 1 (GLP-1) agonist drugs are used to treat diabetes and aid weight loss.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 176 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.030Z"},{"nctId":"NCT07562152","title":"Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma","officialTitle":"A Phase 3 Randomized, Open-Label Study of Atebimetinib in Combination With the Modified Gemcitabine and Nab-Paclitaxel Regimen Versus the Standard Gemcitabine and Nab-Paclitaxel Regimen for the Treatment of Patients With Metastatic Pancreatic Ductal Pancreatic Adenocarcinoma Cancer (MAPKeeper 301)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Immuneering Corporation","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.","conditions":["Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma","Pancreatic Adenocarcinoma Metastatic","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma"],"keywords":["mitogen-activated protein kinase (MAPK)","MAPK","MEK","metastatic cancer","gemcitabine","nab-paclitaxel","nab-p","atebimetinib","KRAS","pan-RAS"],"interventions":[{"type":"DRUG","name":"Atebimetinib"},{"type":"DRUG","name":"GnP"},{"type":"DRUG","name":"mGnP"}],"enrollment":570,"startDate":"2026-06-05","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be ≥18 years of age\n* Must have confirmed diagnosis according to AJCC staging as follows:\n\n  * Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Participants must be treatment naive as follows:\n\n  * First-line PDAC participants will have received no previous systemic anti-cancer therapy\n* Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria\n* Adequate organ function, hepatic function, coagulation studies and protocol determined clinical laboratory values\n\nExclusion Criteria:\n\n* Inability to swallow oral medications\n* Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma\n* Participants with only locally advanced disease\n* Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases","locations":[{"facility":"Clearview Cancer Institute","city":"Huntsville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"City of Hope","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poudre Valley Health Care, Inc","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rocky Mountain Cancer Centers","city":"Lone Tree","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Oncology Hematology Consultants","city":"Newark","state":"Delaware","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Miami Cancer Institute","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hematology Oncology Associates of the Treasure Coast","city":"Port Saint Lucie","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists - 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Galati","city":"Galati","state":"GL","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"SC Sigmedical S.R.L","city":"Suceava","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Investigacion Sanitaria de Aragon (IIS-A)","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Coventry and Warwickshire NHS Trust","city":"Coventry","state":"COV","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals","city":"London","state":"LND","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imperial College Healthcare NHS","city":"London","state":"LND","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scri Uk, Ltd","city":"London","state":"LND","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Christie NHS Foundation","city":"Manchester","state":"MAN","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Immuneering Study Team","phone":"860-321-1302","email":"clinicaltrials@immuneering.com"}],"primaryOutcomes":["Overall Survival"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["huntsville-alabama","phoenix-arizona","duarte-california","san-diego-california","fort-collins-colorado","lone-tree-colorado","newark-delaware","miami-florida","port-saint-lucie-florida","sarasota-florida","st-petersburg-florida","west-palm-beach-florida","atlanta-georgia","arlington-heights-illinois","chicago-illinois","peoria-illinois","fairway-kansas","columbia-maryland","columbia-missouri","omaha-nebraska","las-vegas-nevada","belleville-new-jersey","east-brunswick-new-jersey","new-york-new-york","pinehurst-north-carolina","cincinnati-ohio","maumee-ohio","eugene-oregon","portland-oregon","philadelphia-pennsylvania","greenville-south-carolina","sioux-falls-south-dakota","germantown-tennessee","nashville-tennessee","abilene-texas","austin-texas","san-antonio-texas","webster-texas","blacksburg-virginia","fairfax-virginia","seattle-washington","vancouver-washington","madison-wisconsin","kingswood-australia","waratah-australia","chermside-australia","woolloongabba-australia","adelaide-australia","frankston-east-australia","murdoch-australia","nedlands-australia","tbilisi-georgia","heilbronn-germany","riesa-germany","budapest-hungary","debrecen-hungary","poznan-poland","wroclaw-poland","galati-romania","suceava-romania","pamplona-spain","zaragoza-spain","coventry-united-kingdom","london-united-kingdom","manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Atebimetinib for Pancreatic Cancer","inPlainEnglish":"This study wants to measure the safety and how well it works of atebimetinib in combination with modified GnP compared with SOC GnP alone.","whoItsFor":["Ages 18 Years to any","Must be ≥18 years of age","Must have confirmed diagnosis according to AJCC staging as follows:","Metastatic pancreatic adenocarcinoma within 12 weeks prior to screening","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Participants must be treatment who have not tried this kind of treatment before as follows:","First-line PDAC participants will have received no previous systemic anti-cancer therapy","Must have evidence of measurable disease (at least one target lesion) per RECIST v1.1 criteria"],"whoShouldSkip":["Inability to swallow oral medications","Participant has squamous, adenosquamous, neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma","Participants with only locally advanced disease","Symptomatic, untreated, or actively progressing known central nervous system (CNS) metastases"],"whatHappens":"If you join, the listed intervention(s) are Atebimetinib, GnP, or mGnP. The registry lists allocation as randomized. This study wants to measure the safety and how well it works of atebimetinib in combination with modified GnP compared with SOC GnP alone.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 570 people at 76 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.446Z"},{"nctId":"NCT07562178","title":"Pemafibrate for Symptomatic ICAS RCT","officialTitle":"Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Tokyo Women's Medical University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA).\n\nThe main questions this study aims to answer are:\n\n1. Does pemafibrate lower the chance that ICAS gets worse over 12 months?\n2. Does pemafibrate improve TG levels and other vascular risk markers?\n3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months?\n\nResearchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking.\n\nParticipants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (\\>=150 mg/dL) or non-fasting (\\>=175 mg/dL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy.\n\nParticipants will:\n\n* Be randomly assigned to a pemafibrate group or a non-pemafibrate group\n* Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function\n* Have blood tests and clinical assessments at baseline and during follow-up\n* Undergo brain CTA at study entry and again at 12 months\n* Undergo brain MRI/MRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule\n* Be followed for vascular events, functional outcome, and adverse events for 1 year","conditions":["Intracranial Atherosclerotic Disease (ICAD)","Hypertriglyceridaemia","Stroke (CVA) or TIA"],"keywords":[],"interventions":[{"type":"DRUG","name":"Pemafibrate"}],"enrollment":270,"startDate":"2026-05-26","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \\>=4) between 24 hours and 3 years from onset at enrollment.\n2. Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial artery: intracranial internal carotid artery, middle cerebral artery (M1/M2), anterior cerebral artery (A1), vertebral artery (V4), basilar artery, or posterior cerebral artery (P1).\n3. Fasting triglycerides (TG) 150-499 mg/dL, or non-fasting TG 175-499 mg/dL, measured within 4 weeks prior to consent.\n4. Men or women aged \\>=18 years at the time of consent.\n5. Ability to obtain written informed consent from the patient or a legally authorized representative.\n\nExclusion Criteria:\n\n1. Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection).\n2. Patients with \\>=70% stenosis of the extracranial carotid artery (NASCET criteria).\n3. Patients with neurological deterioration within 24 hours prior to enrollment.\n4. Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment.\n5. Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery).\n6. Patients who meet any contraindication to pemafibrate, including:\n\n(1) History of hypersensitivity to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as Child-Pugh B or C; (3) Cholelithiasis; (4) Pregnancy or suspected pregnancy; (5) Concomitant use of cyclosporine or rifampin. 7. Patients who have taken pemafibrate or any fibrate within 12 weeks prior to consent.\n\n8\\. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia.\n\n11\\. Patients with severe systemic comorbidities with an expected survival \\<12 months.\n\n12\\. Patients who may be pregnant, are pregnant, or are breastfeeding. 13. Any other condition for which the principal or sub-investigator judges participation to be inappropriate.","locations":[{"facility":"Fujita Health University Hospital","city":"Toyoake","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Women's Medical University Yachiyo Medical Center","city":"Yachiyo","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Fukui Hospital","city":"Yoshida","state":"Fukui","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Brain Attack Center Ota Memorial Hospital","city":"Fukuyama","state":"Hiroshima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hiroshima City Hiroshima Citizens Hospital","city":"Hiroshima","state":"Hiroshima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kobe City Medical Center General Hospital","city":"Kobe","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Tsukuba Hospital","city":"Tsukuba","state":"Ibaraki","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iwate Medical University Hospital","city":"Hizume","state":"Iwate","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kagoshima City Hospital","city":"Kagoshima","state":"Kagoshima-ken","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kagoshima Medical Center","city":"Kagoshima","state":"Kagoshima-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokai University Hopital","city":"Isehara","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nippon Medical School Musashikosugi 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Hospital","city":"Kurashiki","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Hirakata","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka National Hospital","city":"Osaka","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Keisatsu Hospital","city":"Osaka","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka General Medical Center","city":"Osaka","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kindai University Hopital","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital","city":"Suita","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saitama Medical University International Medical Center","city":"Hidaka","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Saitama Hospital","city":"Saitama","state":"Saitama","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dokkyo Medical University Hospital","city":"Mibu","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jichi Medical University Hospital","city":"Shimotsuke","state":"Tochigi","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokushima University Hospital","city":"Tokushima","state":"Tokushima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Women's Medical University Adachi Medical Center","city":"Adachi-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Science Tokyo Hospital","city":"Bunkyō-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nippon Medical School Hospital","city":"Bunkyō-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Showa General Hospital","city":"Kodaira","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Showa Medical University Koto Toyosu Hospital","city":"Koto-ku","state":"Tokyo","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Jikei University Hspital","city":"Minato-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Saiseikai Central Hospital","city":"Minato-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyorin University Hospital","city":"Mitaka","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toho University Omori Medical Center","city":"Ōta-ku","state":"Tokyo","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Medical University Hospital","city":"Shinjuku-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Women's Medical University Hospital","city":"Shinjuku-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nippon Medical School Tamanagayama Hospital","city":"Tama","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Yamanashi Hospital","city":"Chūō","state":"Yamanashi","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kenichi Todo, MD, PhD","phone":"+81-3-3353-8111","email":"todo.kenichi@twmu.ac.jp"},{"name":"Takao Hoshino, MD, PhD","phone":"+81-3-3353-8111","email":"hoshino.takao@twmu.ac.jp"}],"primaryOutcomes":["Progression in intracranial arterial stenosis on CTA at 12 months from enrollment (progression vs. no progression [no change or improvement])"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["toyoake-japan","yachiyo-japan","yoshida-japan","fukuyama-japan","hiroshima-japan","kobe-japan","tsukuba-japan","hizume-japan","kagoshima-japan","isehara-japan","kawasaki-japan","kumamoto-japan","kyoto-japan","nagasaki-japan","kurashiki-japan","hirakata-japan","osaka-japan","sakai-japan","suita-japan","hidaka-japan","saitama-japan","mibu-japan","shimotsuke-japan","tokushima-japan","adachi-ku-japan","bunky-ku-japan","kodaira-japan","koto-ku-japan","minato-ku-japan","mitaka-japan","ta-ku-japan","shinjuku-ku-japan","tama-japan","ch-japan"],"enrichment":{"headline":"Not a traditional drug phase: testing Pemafibrate for Intracranial Atherosclerotic Disease (ICAD)","inPlainEnglish":"The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA). The main questions this study aims to answer are: 1.","whoItsFor":["Ages 18 Years to any","Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \\>=4) between 24 hours and 3 years from onset at enrollment","Fasting triglycerides (TG) 150-499 mg/dL, or non-fasting TG 175-499 mg/dL, measured within 4 weeks prior to consent","Men or women aged \\>=18 years at the time of consent"],"whoShouldSkip":["Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection)","Patients with \\>=70% stenosis of the extracranial carotid artery (NASCET criteria)","Patients with neurological deterioration within 24 hours prior to enrollment","Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment","Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery)","Patients who meet any contraindication to pemafibrate, including:","8\\. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia"],"whatHappens":"If you join, the listed intervention(s) are Pemafibrate. The registry lists allocation as randomized. The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 270 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.220Z"},{"nctId":"NCT07563270","title":"GAPcareAD: A Brief Emergency Department Intervention to Address Post-Fall Care Needs of Persons Living With Dementia and Care Partners","officialTitle":"GAPcareAD: A Brief Emergency Department Intervention to Address Post-Fall Care Needs of Persons Living With Dementia and Care Partners","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"Persons living with dementia (PLWD) are at significantly increased risk for falls, which are the leading cause of emergency department (ED) visits in this population and contribute to serious injuries, functional decline, and caregiver burden. GAPcareAD is an ED-initiated, caregiver-inclusive intervention designed to address fall risk at the point of care. This multi-site trial will compare GAPcareAD (intervention) to usual care for 350 PLWD and caregivers after a fall.","conditions":["Alzheimer's Disease and Related Dementia"],"keywords":[],"interventions":[{"type":"OTHER","name":"Fall Prevention"}],"enrollment":700,"startDate":"2026-10-13","completionDate":"2029-03-30","sex":"ALL","minAge":"65 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Community-dwelling adult (living at home or assisted living) 65 years-old or older presenting to ED after a fall within the last seven days\n* Fall not due to syncope or external force (i.e., struck by car,assault, intoxication)\n* Fall not due to serious illness (i.e., stroke, acute myocardial infarction)\n* Patients have an identified caregiver\n* Patient must have known ADRD or score ≥2 on the AD8 Dementia Interview.\n* Anticipated to be discharged to home/assisted living/rehabilitation at the time of consent (i.e. not admitted)\n* The patient and/or caregiver have a reliable phone number where they can be reached throughout the intervention\n\nExclusion Criteria:\n\n* Living in a nursing home\n* Patients are admitted to the hospital\n* Patients who have advanced cancer and/or are in hospice\n* Patients have presence of injuries that prevent mobilization (i.e. pelvic or lower extremity fractures)","locations":[{"facility":"UCH University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Effect of intervention"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["aurora-colorado","st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: Fall Prevention for Alzheimer's Disease and Related Dementia","inPlainEnglish":"Persons living with dementia (PLWD) are at significantly increased risk for falls, which are the leading cause of emergency department (ED) visits in this population and contribute to serious injuries, functional decline, and caregiver burden. GAPcareAD is an ED-initiated, caregiver-inclusive intervention designed to address fall risk at the point of care.","whoItsFor":["Ages 65 Years to any","Community-dwelling adult (living at home or assisted living) 65 years-old or older presenting to ED after a fall within the last seven days","Fall not due to syncope or external force (i.e., struck by car,assault, intoxication)","Fall not due to serious illness (i.e., stroke, acute myocardial infarction)","Patients have an identified caregiver","Patient must have known ADRD or score ≥2 on the AD8 Dementia Interview","Anticipated to be discharged to home/assisted living/rehabilitation at the time of consent (i.e. not admitted)","The patient and/or caregiver have a reliable phone number where they can be reached throughout the intervention"],"whoShouldSkip":["Living in a nursing home","Patients are admitted to the hospital","Patients who have advanced cancer and/or are in hospice","Patients have presence of injuries that prevent mobilization (i.e. pelvic or lower extremity fractures)"],"whatHappens":"If you join, the listed intervention(s) are Fall Prevention. The registry lists allocation as randomized. Persons living with dementia (PLWD) are at significantly increased risk for falls, which are the leading cause of emergency department (ED) visits in this population and contribute to serious injuries, functional decline, and caregiver burden.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 700 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.321Z"},{"nctId":"NCT07563517","title":"Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches & Across INcarceration Settings","officialTitle":"Linking Individuals Needing Care for Substance Use Disorders to Peer Coaches & Across INcarceration Settings","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Emory University","sponsorClass":"OTHER","summary":"The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders.\n\nThe main questions it aims to answer are:\n\n* Does the PRC intervention increase engagement with at least one recovery resource at 30 and 90 days?\n* Does it improve secondary outcomes such as substance use, recovery capital, overdose events, and recidivism?\n\nResearchers will compare Treatment-as-Usual with the PRC telehealth intervention to see if PRC support improves engagement in addiction care.\n\nParticipants will:\n\n* Complete baseline and follow-up assessments\n* Receive either Treatment-as-Usual or a virtual PRC session focused on motivational interviewing and linkage to recovery resources","conditions":["Substance Use"],"keywords":["Support groups","Recovery","Substance use disorders during incarceration"],"interventions":[{"type":"BEHAVIORAL","name":"Virtual Peer Recovery Coaching"},{"type":"BEHAVIORAL","name":"Treatment as Usual"}],"enrollment":550,"startDate":"2027-01","completionDate":"2030-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Incarcerated at participating jail\n* Able to speak and understand English\n* Score of 3 or greater - \"moderate level\", \"substantial level\", or \"severe level\" of problems related to drug abuse - on DAST-10.\n* Willing to follow study procedures and complete research follow-up calls\n* Have at least two reliable contact numbers, e.g. participant and one or more relatives or close friends\n\nExclusion Criteria:\n\n* Cognitive impairment (inability to comprehend the informed consent document as assessed by study staff during enrollment)\n* Prior participation in the study\n* Awaiting transfer to prison or jail outside the state of Georgia","locations":[{"facility":"Atlanta City Detention Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fulton County Jail","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dekalb County Jail","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joseph Carpenter, MD","phone":"404-778-5975","email":"jecarpe@emory.edu"},{"name":"Yan Li","phone":"","email":"yan.li@emory.edu"}],"primaryOutcomes":["Engagement With at Least One Recovery Resource"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","decatur-georgia"],"enrichment":{"headline":"Not a traditional drug phase: Virtual Peer Recovery Coaching for Substance Use","inPlainEnglish":"The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders. The main questions it aims to answer are: * Does the PRC intervention increase engagement with at least one recovery resource at 30 and 90 days?","whoItsFor":["Ages 18 Years to any","Incarcerated at participating jail","Score of 3 or greater - \"moderate level\", \"substantial level\", or \"severe level\" of problems related to drug abuse - on DAST-10","Willing to follow study procedures and complete research follow-up calls","Have at least two reliable contact numbers, e.g. participant and one or more relatives or close friends"],"whoShouldSkip":["Prior participation in the study","Awaiting transfer to prison or jail outside the state of Georgia"],"whatHappens":"If you join, the listed intervention(s) are Virtual Peer Recovery Coaching, or Treatment as Usual. The registry lists allocation as randomized. The goal of this study is to learn whether a virtual peer recovery coach (PRC) intervention can improve engagement in addiction treatment among incarcerated adults with substance use disorders.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 550 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.490Z"},{"nctId":"NCT07563738","title":"A 2-part Phase 1/2 Open-label Trial on ODM-212","officialTitle":"A 2-part Phase 1/2 Open-label Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ODM-212 in Combination With Anti-cancer Therapy in Participants With Advanced Solid Tumours","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Orion Corporation, Orion Pharma","sponsorClass":"INDUSTRY","summary":"An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)","conditions":["Mesothelioma","Pancreatic Cancer","NSCLC (Advanced Non-small Cell Lung Cancer)"],"keywords":[],"interventions":[{"type":"DRUG","name":"ODM-212"},{"type":"DRUG","name":"Ipilimumab and nivolumab"},{"type":"DRUG","name":"Gemcitabine and nab-paclitaxel"},{"type":"DRUG","name":"sotorasib"}],"enrollment":229,"startDate":"2026-03-27","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female participants ≥18 years old.\n* Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.\n* Life expectancy of \\>12 weeks, in the opinion of the investigator.\n* Ability to take oral medications and willing to record daily adherence to investigational product.\n* Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator.\n\n  * Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab/nivolumab; participants must not have undergone surgical therapy for mesothelioma.\n  * Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine.\n  * Arm C: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who have received the available 1st line treatment and who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.\n\nPart 2:\n\n* Ipilimumab/nivolumab cohort: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive a treatment with ipilimumab/nivolumab. Prior treatment with ipilimumab, nivolumab and/or other PD-1/PD-L1/CTLA-4 inhibitors for advanced or metastatic disease is not allowed.\n* Nab-paclitaxel/gemcitabine cohort: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive a treatment with nab-paclitaxel and gemcitabine. Previous treatments with nab-paclitaxel and/or gemcitabine for metastatic disease are not allowed.\n* Sotorasib cohort, treatment naïve: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who are eligible for a treatment with sotorasib and have not received a KRAS G12C inhibitor as prior treatment.\n* Sotorasib cohort, pretreated: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C mutation, confirmed using a validated test, who have documented progression on a prior KRAS G12C inhibitor (approved or investigational).\n\n  * Part 2 only: Participants must have measurable disease by response evaluation criteria in solid tumours (RECIST) v. 1.1 (modified RECIST for MPM).\n  * A recent (taken up to 1 year ago), representative tumour tissue sample (from primary tumour or from metastasis) must be available. Tissue must be a core needle biopsy, excisional or incisional biopsy. Biopsies of bone lesions that do not have a soft tissue component or decalcified bone tumour samples are also not acceptable.\n  * Amenable for paired fresh tumour biopsy at screening period and on-treatment.\n\nExclusion Criteria:\n\n* Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants has completed curative therapy.\n* Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment administration.\n* Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and asymptomatic laboratory abnormalities). Ongoing adjuvant treatments for previous cancers are allowed as concomitant treatments if they do not have direct anti-tumour effect on the index tumour (e.g. hormone-suppressing agents).\n* Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared sufficiently from the participant's body before trial treatment administration.\n* Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy.\n* Any severe active infection within 1 week of trial enrolment.\n* Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive of HIV, HBV or HCV infection.\n* Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).\n* Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \\>10 mg/day prednisone or equivalent) within 2 days before trial treatment administration.\n* Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.\n* Use of other investigational medicinal products within 2 weeks or at least 5 half-lives (whichever is longer) before trial treatment administration, or any persistent unresolved toxicity from such treatment that, according to the judgement of the investigator, may pose a health risk for the participant, if taking part in the trial. For drugs such as investigational monoclonal antibodies with half-lives \\>10 days, at least 8 weeks is required. In addition, all visits (apart from survival follow-up) related to the use of another IMP must be completed before dosing with trial treatments may commence.\n* Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, shingles, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of study drug.\n* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\>250 ms, a prolonged QTc interval (QTcF/B \\>470 ms) as demonstrated by 2 out of 3 repeated ECG at screening, performed according to local practice. A history of risk factors for torsade de pointes (e.g. heart failure, hypokalaemia, family history of long QT Syndrome) or the use of drugs that prolong the QT interval and are clearly associated with a known risk of torsade de pointes, even when taken as recommended per Crediblemeds.org QTdrugs list.\n* Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left ventricular ejection fraction (LVEF) \\<50%, cardiac arrhythmia requiring medical treatment (including oral anticoagulation) within 6 months prior to the first dose of trial treatment.\n* Female participants who are breastfeeding or pregnant at screening or baseline. A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.","locations":[{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC Irvine Health","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Dallas-Fort Worth","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Oncology Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aalborg Universitets hospital","city":"Aalborg","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet University","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Helsinki University Hospital","city":"Helsinki","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Turku University Hospital","city":"Turku","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Bergonie","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marseille University Hospital Timone","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Poitiers","city":"Poitiers","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"HM Nou Delfos","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICO Hospitale","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vall D'Hebron University Hospital","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HM Sanchinarro","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Madrid FJD","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Regionale Bellinzona","city":"Bellinzona","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leicester Royal Infirmary","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Southampton","city":"Southampton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Study Director","phone":"+358104261","email":"clinicaltrials@orionpharma.com"}],"primaryOutcomes":["Incidence of Dose Limiting Toxicities and Adverse Events"],"hasResults":false,"conditionSlugs":["lung-cancer","pancreatic-cancer"],"drugSlugs":["nivolumab","sotorasib"],"locationSlugs":["los-angeles-california","orange-california","fort-worth-texas","irving-texas","fairfax-virginia","aalborg-denmark","copenhagen-denmark","helsinki-finland","turku-finland","bordeaux-france","marseille-france","poitiers-france","villejuif-france","barcelona-spain","madrid-spain","bellinzona-switzerland","leicester-united-kingdom","london-united-kingdom","southampton-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ODM-212 for Mesothelioma","inPlainEnglish":"An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)","whoItsFor":["Ages 18 Years to any","Male or female participants ≥18 years old","Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale","Life expectancy of \\>12 weeks, in the opinion of the investigator","Ability to take oral medications and willing to record daily adherence to investigational product","Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial according to the investigator","Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab/nivolumab; participants must not have undergone surgical therapy for mesothelioma","Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine"],"whoShouldSkip":["Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants has completed curative therapy","Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment administration","Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy","Any severe active infection within 1 week of trial enrolment","Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive of HIV, HBV or HCV infection","Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2)","Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \\>10 mg/day prednisone or equivalent) within 2 days before trial treatment administration"],"whatHappens":"If you join, the listed intervention(s) are ODM-212, Ipilimumab and nivolumab, or Gemcitabine and nab-paclitaxel. The registry lists allocation as randomized. An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 229 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.457Z"},{"nctId":"NCT07563868","title":"Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression","officialTitle":"Coaching as an Adjunct to Ketamine Therapy for Treatment-Resistant Depression","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD). The investigators are currently enrolling participants who are receiving ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment at the MGH Ketamine Clinic. Participation in the study will involve adding coaching sessions to your existing ketamine maintenance treatment.","conditions":["Treatment Resistant Depression (TRD)"],"keywords":["Psychedelic Coaching","Ketamine Coaching","Depression"],"interventions":[{"type":"BEHAVIORAL","name":"Psychedelic Integration Coaching"}],"enrollment":20,"startDate":"2026-04-17","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years or older at the time of informed consent/study enrollment.\n2. Ability to understand and provide informed consent.\n3. Fluent in English (spoken and written).\n4. Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform.\n5. Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit.\n6. Lifetime diagnosis of a depressive disorder according to the MINI.\n7. In the maintenance phase of ketamine or esketamine treatment, defined as the period following the initial acute treatment series (typically 2 treatments per week for 3 weeks).\n8. Patients must have completed at least 3 maintenance treatments prior to screening visit with a QIDS-SR score ≥ 11 noted from EPIC medical records from the 3 most recent maintenance treatments.\n9. Currently receiving maintenance IV ketamine or intranasal esketamine at the MGH Ketamine Clinic, with at least one treatment administered within the past 8 weeks, and planning to continue to be an active patient at the MGH Ketamine Clinic for the duration of the study.\n10. Has established care with a mental health provider (e.g., psychiatrist, therapist, or other licensed mental health clinician), and, if outside the MGB-healthcare system, agrees to sign a Release of Information form (ROI) with the study team.\n\nExclusion Criteria:\n\n1. Presence of an unstable medical condition, as determined by the study clinician.\n2. Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment.\n3. Newly initiated psychotherapy within the past 3 months.\n4. Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable.\n5. Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would interfere with study participation, per clinician judgment.\n6. Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point during study.\n7. Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months.\n8. A ≥25% reduction in QIDS total score from screen to baseline visit.","locations":[{"facility":"Massachusetts General Hospital's Depression and Clinical Research program","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maren Nyer, PhD","phone":"6176434897","email":"mnyer@mgh.harvard.edu"},{"name":"Franklin King, MD","phone":"","email":"fking@mgh.harvard.edu"}],"primaryOutcomes":["To assess the feasibility of adjunctive coaching during ketamine/esketamine maintenance treatment.","To assess the acceptability of adjunctive coaching during ketamine/esketamine maintenance treatment."],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Psychedelic Integration Coaching for Treatment Resistant Depression (TRD)","inPlainEnglish":"This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD). The investigators are currently enrolling participants who are receiving ongoing maintenance intravenous (IV) ketamine or intranasal esketamine (Spravato) treatment at the MGH Ketamine Clinic.","whoItsFor":["Ages 18 Years to any","Fluent in English (spoken and written)","Willingness to have coaching sessions recorded via HIPAA-compliant MGB approved video-based platform","Has a QIDS-SR score ≥ 11, indicating at least moderate depressive symptom severity at screening visit","Lifetime diagnosis of a depressive disorder according to the MINI","In the maintenance phase of ketamine or esketamine treatment, defined as the period following the initial acute treatment series (typically 2 treatments per week for 3 weeks)","Patients must have completed at least 3 maintenance treatments prior to screening visit with a QIDS-SR score ≥ 11 noted from EPIC medical records from the 3 most recent maintenance treatments","Currently receiving maintenance IV ketamine or intranasal esketamine at the MGH Ketamine Clinic, with at least one treatment administered within the past 8 weeks, and planning to continue to be an active patient at the MGH Ketamine Clinic for the duration of the study"],"whoShouldSkip":["Presence of an unstable medical condition, as determined by the study clinician","Significant neurocognitive impairment that impairs with individual's ability to maintain ADLs and would interfere with study participation, per study clinician judgment","Newly initiated psychotherapy within the past 3 months","Any condition or circumstance that, in the judgment of the Principal Investigator, makes participation unsafe or unsuitable","Any psychiatric condition that is currently primary, clinically predominant to their depression, or insufficiently stable such that it would interfere with study participation, per clinician judgment","Plan to switch from IV ketamine treatment to intranasal esketamine or plan to switch from intranasal esketamine to IV ketamine treatment at any point during study","Suicidality determined by the judgment of the study clinicians at screen, with a plan to act in next 6 months"],"whatHappens":"If you join, the listed intervention(s) are Psychedelic Integration Coaching. The registry lists allocation as na. This study is being conducted at Massachusetts General Hospital (MGH) to explore whether adding psychedelic coaching can enhance the effects of ketamine or esketamine maintenance treatment in individuals with treatment-resistant depression (TRD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.793Z"},{"nctId":"NCT07563881","title":"Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Rapport Therapeutics Inc.","sponsorClass":"INDUSTRY","summary":"This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.","conditions":["Focal Seizure","Epilepsy","Focal Epilepsy"],"keywords":["Focal Preserved Consciousness","Focal Impaired Consciousness"],"interventions":[{"type":"DRUG","name":"RAP-219"},{"type":"DRUG","name":"RAP-219"},{"type":"OTHER","name":"Placebo"}],"enrollment":333,"startDate":"2026-06-05","completionDate":"2029-07","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 - 75\n2. BMI 18-45 kg/m2\n3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1\n4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis\n5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs\n6. Ability to keep accurate daily focal seizure records using an e-diary\n\nExclusion Criteria:\n\n1. Known hypersensitivity or prior exposure to RAP-219.\n2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur\n3. Anticipated need for surgery during the study period\n4. Medical history of any of the following:\n\n   1. generalized epilepsy\n   2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type\n   3. psychogenic nonepileptic seizure (PNES)\n   4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).\n   5. epilepsy surgery within 12 months prior to Visit 1 (Day -56).\n5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amicis Research Center","city":"Palmdale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Panhandle Research and Medical Clinic, LLC","city":"Gulf Breeze","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory Brain Health Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consultants in Epilepsy & Neurology, PLLC","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois University Neurology Clinic","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University Health Fort Wayne Neurology","city":"Fort Wayne","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid-Atlantic Epilepsy and Sleep Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northeast Regional Epilepsy Group","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of Neurology and Neurosurgery at St. Barnabas","city":"Livingston","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health - Comprehensive Epilepsy Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asheville Neurology Specialists","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurological Associates","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred Hospital","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital","city":"Sydney","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dong-A University Hospital","city":"Busan","state":"Republic of Korea","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"Republic of Korea","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital","city":"Seoul","state":"Republic of Korea","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hopsital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Plymouth NHS Trust","city":"Plymouth","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rapport Medical","phone":"857 323 9048","email":"RAP-219-FOS@rapportrx.com"}],"primaryOutcomes":["Median Percent Change in Seizure Frequency"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","palmdale-california","gulf-breeze-florida","atlanta-georgia","boise-idaho","springfield-illinois","fort-wayne-indiana","bethesda-maryland","hackensack-new-jersey","livingston-new-jersey","new-york-new-york","the-bronx-new-york","asheville-north-carolina","cleveland-ohio","philadelphia-pennsylvania","richmond-virginia","melbourne-australia","sydney-australia","busan-south-korea","seoul-south-korea","plymouth-united-kingdom"],"enrichment":{"headline":"Phase 3: testing RAP-219 for Focal Seizure","inPlainEnglish":"This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of focal epilepsy for ≥24 months prior to Visit 1","Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis","Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs","Ability to keep accurate daily focal seizure records using an e-diary"],"whoShouldSkip":["Known hypersensitivity or prior exposure to RAP-219","Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur","Anticipated need for surgery during the study period","Medical history of any of the following:","generalized epilepsy","focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type","psychogenic nonepileptic seizure (PNES)"],"whatHappens":"If you join, the listed intervention(s) are RAP-219, RAP-219, or Placebo. The registry lists allocation as randomized. This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 333 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.901Z"},{"nctId":"NCT07564505","title":"A Clinical Trial of Taibowei® Adalimumab Injection in the Treatment of Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease","officialTitle":"Post-marketing Case Registration Study on the Safety and Efficacy of Taibowei® Adalimumab Injection for Chinese Pediatric Patients With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to evaluate the incidence of serious adverse events (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of adverse events (AEs), adverse drug reactions (ADRs), adverse events of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.","conditions":["Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Adalimumab Solution for Injection"}],"enrollment":30,"startDate":"2026-08-13","completionDate":"2029-03","sex":"ALL","minAge":"6 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender.\n* Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the \"Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019\".\n* (3) Pediatric Crohn's disease patients who have been prescribed Adalimumab Solution for Injection by doctors after a full assessment of risks/benefits.Both the patient and their guardian must sign the informed consent form. The research protocol/informed consent form used for data collection and data verification should comply with local laws and regulatory requirements.\n\nExclusion Criteria:\n\n* (1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection.\n* (2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period.\n* Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial.","locations":[{"facility":"Women and Children's Medical Center, Guangzhou Medical University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lanlan Geng, Doctor","phone":"18902268612","email":"13622237569@163.com"}],"primaryOutcomes":["The incidence of adverse events (AE), adverse drug reactions (ADR), adverse events of special interest (AESI) and serious ADR at 12, 26 and 52 weeks after treatment"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 4: testing Adalimumab Solution for Injection for Children Aged 6 Years and Above With Moderate - to - Severe Active Crohn's Disease","inPlainEnglish":"This study is a real - world clinical research of adalimumab. The project plans to enroll 30 subjects, aiming to measure the incidence of serious side effects (SAEs) within 12, 26, and 52 weeks after treatment; as well as the incidence of side effects (AEs), adverse drug reactions (ADRs), side effects of special interest (AESIs), and serious ADRs at 12, 26, and 52 weeks after treatment.","whoItsFor":["Ages 6 Years to 17 Years","Age is between 6 years old (inclusive) and 17 years old (inclusive), regardless of gender","Diagnosed as having moderate - to - severe active pediatric Crohn's disease according to the \"Expert Consensus on the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease 2019\""],"whoShouldSkip":["(1) According to the instruction manual of Adalimumab Solution for Injection and the judgment of the treating physician, the patient is not suitable for treatment with Adalimumab Solution for Injection","(2) Pediatric Crohn's disease patients who have received any live vaccines within 3 months prior to the first dose of Adalimumab Solution for Injection or who plan to receive any live vaccines during the study period","Patients who are participating in other clinical studies. (4) Patients whom the investigator deems unsuitable for participation in this trial"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab Solution for Injection. The registry lists allocation as na. This study is a real - world clinical research of adalimumab.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 30 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.267Z"},{"nctId":"NCT07565493","title":"Psilocybin Administration With 5-HT1a Blockade","officialTitle":"Psilocybin Administration With 5-HT1a Blockade","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.","conditions":["Psychedelic Effects in Healthy Volunteers"],"keywords":["Psilocybin","Sleep","Dreaming","EEG","5-HT1A","Antagonism","Altered state of consciousness","Subjective experience","Serotonin receptor","Psychedelic"],"interventions":[{"type":"DRUG","name":"Pindolol"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Psilocybin"}],"enrollment":18,"startDate":"2026-08-12","completionDate":"2028-06-15","sex":"ALL","minAge":"21 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion criteria:\n\n* 21 - 60 years old\n* Must give written or electronic informed consent\n* Must have at least a high-school level of education or equivalent (e.g. GED) and are fluent in English\n* Must be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Must agree not to take any as needed (PRN) medications on the mornings of drug sessions\n* Must agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n* Must agree to refrain from using all psychoactive substances within 24 hours or 5 elimination half-lives (whichever is greater) before psilocybin administration. Caffeine is the exception.\n* Must have a negative urine toxicology report on the same day as drug dosing.\n* Who are female and of child-bearing potential and are sexually active, must agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study.\n* Who are male and sexually active, must agree to use contraception and refrain from sperm donation within 90 days of completing dosing sessions. Effective methods of contraception are barrier, hormonal, and sterilization methods.\n\nExclusion Criteria:\n\n* Are currently taking a medication with any significant pharmacokinetic or pharmacodynamic interactions with pindolol (e.g. beta-blockers or other anti-hypertensive medications).\n* Have a history of orthostatic hypotension or low blood-pressure.\n* Have elevated transaminases (2x the upper limit of normal)\n* Have a Child-Pugh score that falls within classes B or C.\n* Are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing.\n* Have cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation, corrected QT interval (QTc) \\> 450 msec), artificial heart valve, symptomatic valvopathy, history of pulmonary hypertension or transient ischemic attack (TIA) in the past year; systolic blood pressure \\> 139, diastolic blood pressure \\> 89\n* Have epilepsy or a history of seizures\n* Have insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Are currently taking on a regular (e.g. daily) basis any medications having a centrally acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.\n* Have a current diagnosis of schizophrenia spectrum disorders\n* Have a current diagnosis of bipolar spectrum disorders\n* Have a current diagnosis of major depressive disorder or Generalized Anxiety Disorder\n* Have a current diagnosis or history of substance induced psychotic disorder\n* Have a current DSM-5 moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)\n* Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder.\n* Have a psychiatric condition judged to be incompatible with establishment of safe exposure to psilocybin.\n* Have a BMI ≥ 40\n* Report a known history of sleep apnea, symptoms indicative of sleep apnea, or have an Apnea-Hypopnea Index (AHI) \\> 15, or STOP BANG \\>5\n* Taking prescribed hypnotics or other medications known to alter sleep physiology: i.e., Z-drugs, Benzodiazepines, Orexin Agonists or Antagonist, Beta Blockers.\n* Regularly taking over-the-counter sleep aids (inc. melatonin and diphenhydramine) and unwilling to abstain during the study.\n* Insomnia Severity Index ≥ 10","locations":[{"facility":"Center for Psychedelics and Consciousness Research","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zarmeen Zahid, PhD","phone":"667-208-8099","email":"psilblock@jh.edu"}],"primaryOutcomes":["Mystical Experiences Questionnaire"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Early phase 1: testing Pindolol for Psychedelic Effects in Healthy Volunteers","inPlainEnglish":"This study wants to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.","whoItsFor":["Ages 21 Years to 60 Years","Must have at least a high-school level of education or equivalent (e.g. GED) and are fluent in English","Must be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests","Must agree not to take any as needed (PRN) medications on the mornings of drug sessions","Must agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration","Must agree to refrain from using all psychoactive substances within 24 hours or 5 elimination half-lives (whichever is greater) before psilocybin administration. Caffeine is the exception","Must have a negative urine toxicology report on the same day as drug dosing","Who are male and sexually active, must agree to use contraception and refrain from sperm donation within 90 days of completing dosing sessions. Effective methods of contraception are barrier, hormonal, and sterilization methods"],"whoShouldSkip":["Are currently taking a medication with any significant pharmacokinetic or pharmacodynamic interactions with pindolol (e.g. beta-blockers or other anti-hypertensive medications)","Have a history of orthostatic hypotension or low blood-pressure","Have elevated transaminases (2x the upper limit of normal)","Have a Child-Pugh score that falls within classes B or C","Are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing","Have epilepsy or a history of seizures","Have insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia"],"whatHappens":"If you join, the listed intervention(s) are Pindolol, Placebo, or Psilocybin. The registry lists allocation as randomized. This study wants to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 18 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.104Z"},{"nctId":"NCT07566468","title":"Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)","officialTitle":"Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention Deficit Hyperactivity Disorder (ADHD) and Obsessive Compulsive Disorder (OCD)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nAttention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses. Obsessive compulsive disorder (OCD) is less common in children but not rare. It involves ongoing thoughts, urges, impulses, and repeated behaviors. Researchers want to study differences in brain activity between healthy children, those with ADHD, and those with OCD.\n\nObjective:\n\nTo learn more about how the brain controls thinking and behavior.\n\nEligibility:\n\nPeople aged 10 to 17 years with ADHD, OCD, or neither.\n\nDesign:\n\nParticipants will have 3 to 10 clinic visits in up to 1 year. Each visit will last 2 to 3 hours.\n\nThree visits are required:\n\nBehavioral. Participants will complete a computer task. Their mood, memory, attention, and thinking skills will be tested.\n\nEEG. Participants will undergo electroencephalography (EEG) to measure signals in their brain. Small electrodes will be placed on the scalp. A cap will be stretched over the head. Signals will be recorded while participants rest or do tasks on a computer.\n\nMRI. Participants will have a magnetic resonance imaging scan (MRI). They will lie on a table that rolls into a tube. The MRI will take pictures of their brain while they do tasks on a computer.\n\nSeven more visits are optional. These include 2 more EEG visits and 2 more MRI visits.\n\nThree will be magnetoencephalography (MEG) visits: MEG measures small magnetic field changes in the brain. A helmet with sensors will be placed on the head. Brain changes will be recorded while participants rest or do tasks on a computer.","conditions":["ADHD","Obsessive Compulsive Disorder (OCD)","Healthy Volunteer"],"keywords":["EEG","MRI","fMRI"],"interventions":[],"enrollment":110,"startDate":"2026-09-30","completionDate":"2029-05-31","sex":"ALL","minAge":"10 Years","maxAge":"17 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Ability to provide informed assent and parent consent\n  2. Age: 10-17 years\n  3. ADHD Group: Diagnosis of ADHD based on DSM-5 criteria\n\n     OCD Group: Diagnosis of OCD based on DSM-5 criteria\n\n     HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria\n  4. Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \\> 70.\n  5. Normal or corrected to normal vision\n\nEXCLUSION CRITERIA:\n\nParticipants will be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid.\n\n1. Non-English Speakers\n2. Pregnancy\n3. Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;\n4. Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;\n5. Individuals currently taking stimulant medications who cannot tolerate being off their medication for up to 48 hours prior to the study visit and experience an exacerbation of symptoms that necessitates the resumption of medication prior to completion of the study visit.\n6. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n7. For the HV group, any impairing current psychiatric diagnosis.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lindsay M Oberman, Ph.D.","phone":"(301) 435-7962","email":"lindsay.oberman@nih.gov"}],"primaryOutcomes":["Participant Retention for all visits of the study and task performance.","Adverse Events reported related to study procedures","Percentage of EEG and fMRI data deemed to be of sufficient quality for analysis (e.g. without artifact or excessive motion).","Structural cortical region source localized from a combination of the EEG (and MEG in a subset of patients) and fMRI data"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Role of Theta Frequency Oscillations in Proactive and Reactive Control Processes in Youth With Attention De…","inPlainEnglish":"Background: Attention deficit hyperactivity disorder (ADHD) is common in children. It can cause problems with attention and the ability to control actions and impulses.","whoItsFor":["Ages 10 Years to 17 Years","Ability to provide informed assent and parent consent","ADHD Group: Diagnosis of ADHD based on DSM-5 criteria","OCD Group: Diagnosis of OCD based on DSM-5 criteria","HV Group: No Neurological or Psychiatric diagnosis based on DSM-5 criteria","Wechsler Abbreviated Scale of Intelligence, Second Edition (WASI-II). WASI-II will be used as a measure of intellectual function. Children will be included when FSIQ \\> 70","Normal or corrected to normal vision"],"whoShouldSkip":["you would be screened to exclude participants in whom MRI or EEG might result in increased risk of side effects or complications or whose data would not be scientifically valid","Non-English Speakers","Any implant, prosthesis or alteration of the body that, in the opinion of the investigator, would be unsafe with MRI or EEG or that would produce an artifact that would compromise the integrity of data;","Active or History of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments;","Individuals currently taking stimulant medications who cannot tolerate being off their medication for up to 48 hours prior to the study visit and experience an exacerbation of symptoms that necessitates the resumption of medication prior to completion of the study visit","For the HV group, any impairing current psychiatric diagnosis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 110 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.656Z"},{"nctId":"NCT07566494","title":"Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease","officialTitle":"A Phase 1 Study to Evaluate the Safety and Tolerability of Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"Background:\n\nSickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen. Research has shown that curcumin, a natural compound found in turmeric, can improve the health of red blood cells in people with SCD. But the body cannot absorb curcumin well when it is taken by mouth. Researchers want to know if a skin gel (VAS-101) can help the body better absorb curcumin. VAS-101 contains curcumin, which comes from turmeric.\n\nObjective:\n\nTo test VAS-101 in people with stable SCD.\n\nEligibility:\n\nPeople aged 18 to 70 years with stable SCD.\n\nDesign:\n\nPeople who want to join the study will be screened with physical exam with blood tests to see if they are eligible. If they qualify, they can enroll in the study.\n\nParticipants will have up to 15 clinic visits over about 14 weeks. Some may need to stay overnight in the hospital for up to 2 days to make it easier to collect blood samples after the gel is applied.\n\nFor 6 weeks, a special gel called VAS-101 will be put on the forearms in the clinic two times a week. Staff will rub the gel into the skin for at least 30 seconds using a soft toothbrush. The area stays uncovered for at least 10 minutes, then is covered with a bandage or sleeve. After 24 hours, the dressing can be removed and the skin can be washed.\n\nSome visits will include blood tests and other exams. On three visits, a test called near infrared spectroscopy (NIRS) will be done. For this test, probes are placed on the skin to measure blood flow, oxygen levels, and the makeup of skin and muscle. A blood pressure cuff is used to squeeze the arm for up to 5 minutes.\n\nThe last clinic visit will happen about 4 weeks after the final gel application....","conditions":["Sickle Cell Disease, Hemolytic Anemia"],"keywords":[],"interventions":[{"type":"DRUG","name":"VAS-101"}],"enrollment":25,"startDate":"2026-07-31","completionDate":"2027-04-27","sex":"ALL","minAge":"18 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nSubjects will enroll onto the study and undergo screening. Subjects who do not meet any of the following criteria during screening will not receive the study intervention but will be counted toward study accrual. Screen failures may be rescreened at a later time. In order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Have provided signed written informed consent prior to performing any study procedure, including screening procedures.\n* Age between 18-70 years. Adults over 70 years of age will be excluded from this study due to an increased risk of more severe disease and higher prevalence of multiple comobodities.\n* Unequivocal diagnosis of SCD (HbSS, HbSC, HbSbeta+ or HbSbeta\\^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused.\n* No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)\n* Serum aspartate aminotransferase (AST) \\<= 1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\<=1.5 x ULN.\n* Hemoglobin \\>= 7 g/dL\n* Serum creatinine \\<=1.25 x ULN. If serum creatinine is \\>1.25 x ULN, then glomerular filtration rate (based on creatinine) must be \\>=60 mL/min.\n* If on hydroxyurea, participant must have been on stable dose of hydroxyurea (defined as a stable dose for at least 90 days and inclusive of dose modifications for hematological toxicity per PI discretion) prior to signing consent.\n* If on L-glutamine and/or crizanlizumab, participant must have been on a stable dose for ast least 90 days prior to signing consent.\n* Agree to abstain from taking any other products/supplements containing turmeric or curcumin until all study visits have been completed (oral, topical, etc.)\n* For women of reproductive potential, have a negative serum pregnancy test during the screening period. Women of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion; or who have not been naturally postmenopausal (i.e., who have not menstruated at all for at least the preceding 1 year prior to signing informed consent unrelated to hormonal contraception).\n* Women of reproductive potential be abstinent as part of their usual lifestyle, or agree to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 28 days following the last dose of study treatment. An effective form of contraception is defined as hormonal oral contraceptives, injectables, patches, intrauterine or subdermal contraceptive implants, and barrier methods.\n* Be willing to comply with all study procedures for the duration of the study.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Vaso-occlusive crisis requiring parenteral treatment within 14 days of signing consent.\n* Three or more vaso-occlusive crises in the 12 months prior to screening that resulted in receiving treatment in an urgent care, outpatient infusion center/day-clinic, emergency department or inpatient setting.\n* Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:\n\n  * Poorly controlled hypertension (defined as systolic blood pressure \\[BP\\] \\>150 mmHg or diastolic BP \\>90 mmHg) refractory to medical management.\n  * History of recent (within 24 weeks prior to signing consent) decompensated congestive heart failure; myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism.\n  * Clinically symptomatic cholelithiasis or cholecystitis. Prior cholecystectomy is not exclusionary. Subjects with symptomatic cholelithiasis or cholecystitis may be rescreened once the disorder has been treated and clinical symptoms have resolved.\n  * History of drug-induced cholestatic hepatitis.\n  * Iron overload sufficiently severe to result in a clinical diagnosis by the Investigator of cardiac (e.g., clinically significant impaired left ventricular ejection fraction), hepatic (e.g., fibrosis, cirrhosis), or pancreatic (e.g., diabetes) dysfunction.\n  * Positive test for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (Ab) with signs of active hepatitis B or C virus infection. If the subject is positive for HCVAb, a reverse transcriptase-polymerase chain reaction test will be conducted. Subjects with hepatitis C may be rescreened after receiving appropriate hepatitis C treatment.\n  * Active infection requiring any use of systemic antimicrobial agents (parenteral or oral) or Grade \\>=3 in severity (per National Cancer Institute Common Terminology Criteria for Adverse Events) within 4 weeks prior to signing consent.\n  * Diabetes mellitus judged to be under poor control by the Investigator or requiring \\>3 antidiabetic agents, including insulin (all insulins are considered 1 agent); use of insulin per se is not exclusionary.\n  * History of any primary malignancy, with the exception of: curatively treated nonmelanomatous skin cancer; curatively treated cervical or breast carcinoma in situ; or other primary tumor treated with curative intent, no known active disease present, and no treatment administered during the last 3 years.\n  * Current or recent history of psychiatric disorder that, in the opinion of the Investigator or Medical Monitor, could compromise the ability of the subject to cooperate with study visits and procedures.\n  * Have had a prior bone marrow or stem cell transplant.\n* Are currently enrolled in another therapeutic clinical trial involving ongoing therapy with any investigational or marketed product or placebo.\n* Taking nitroglycerin, or any other nitrate-enhancing drug.\n* Have exposure to any investigational drug, device, or invasive procedure within 12 weeks prior to signing consent. All non-investigational invasive procedures within 12 weeks of signing consent may be considered as a potential exclusion criteria per the PI's discretion.\n* Currently pregnant or breastfeeding.\n* Currently receiving hematopoietic stimulating agents (e.g., erythropoietins, granulocyte colony stimulating factors, thrombopoietins) that have not been stopped for a duration of at least 90 days prior to signing consent.\n* Have a history of allergy to turmeric, curcuminoids, or formulations thereof.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jordan B Branch","phone":"(301) 221-3820","email":"jordan.branch@nih.gov"},{"name":"Swee Lay Thein, M.D.","phone":"(301) 435-2345","email":"sweelay.thein@nih.gov"}],"primaryOutcomes":["To assess the clinical safety and tolerability of escalating doses of a patented, bioavailability-enhanced, transdermal application of curcuminoids, VAS-101 / Vasceptor (8.5% curcuminoids transdermal gel), in adult patients with stable SCD."],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing VAS-101 for Sickle Cell Disease, Hemolytic Anemia","inPlainEnglish":"Background: Sickle cell disease (SCD) is an inherited blood disorder. The disease affects the ability of red blood cells to carry oxygen.","whoItsFor":["Ages 18 Years to 90 Years","Age between 18-70 years. Adults over 70 years of age will be excluded from this study due to an increased risk of more severe disease and higher prevalence of multiple comobodities","Unequivocal diagnosis of SCD (HbSS, HbSC, HbSbeta+ or HbSbeta\\^0) confirmed by hemoglobin electrophoresis performed on patients at least 60 days after a blood transfusion if previously transfused","No transfusion in the 60 days prior to signing consent, or absence of Hb A on hemoglobin analysis (by high-performance liquid chromatography; HPLC)","Serum aspartate aminotransferase (AST) \\<= 1.5 x Upper Limit of Normal (ULN) (unless the increased AST is assessed by the Investigator as due to hemolysis) and alanine aminotransferase (ALT) \\<=1.5 x ULN","Hemoglobin \\>= 7 g/dL","Serum creatinine \\<=1.25 x ULN. If serum creatinine is \\>1.25 x ULN, then glomerular filtration rate (based on creatinine) must be \\>=60 mL/min","If on hydroxyurea, participant must have been on stable dose of hydroxyurea (defined as a stable dose for at least 90 days and inclusive of dose modifications for hematological toxicity per PI discretion) prior to signing consent"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Vaso-occlusive crisis requiring parenteral treatment within 14 days of signing consent","Three or more vaso-occlusive crises in the 12 months prior to screening that resulted in receiving treatment in an urgent care, outpatient infusion center/day-clinic, emergency department or inpatient setting","Have a significant medical condition that confers an unacceptable risk to participating in the study, and/or that could confound the interpretation of the study data. Such significant medical conditions include, but are not limited to the following:","Poorly controlled hypertension (defined as systolic blood pressure \\[BP\\] \\>150 mmHg or diastolic BP \\>90 mmHg) refractory to medical management","History of recent (within 24 weeks prior to signing consent) decompensated congestive heart failure; myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism","Clinically symptomatic cholelithiasis or cholecystitis. Prior cholecystectomy is not exclusionary. Subjects with symptomatic cholelithiasis or cholecystitis may be rescreened once the disorder has been treated and clinical symptoms have resolved"],"whatHappens":"If you join, the listed intervention(s) are VAS-101. The registry lists allocation as na. Background: Sickle cell disease (SCD) is an inherited blood disorder.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 25 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.840Z"},{"nctId":"NCT07568496","title":"Greater Occipital Nerve Block for Migraine With Medication Overuse Headache","officialTitle":"Greater Occipital Nerve Block for Migraine With Medication Overuse Headache","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Mahidol University","sponsorClass":"OTHER","summary":"Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH). Treatment of MOH is challenging and the primary therapeutic approach is reducing painkillers which helps decrease the number of headache days. As a part of the detoxification process to discontinue acute medications, bridging therapy is often needed to reduce withdrawal headache. Currently, there are data supporting the use of greater occipital nerve block as a preventive treatment in chronic migraine, but no placebo-controlled trial has evaluated the efficacy of greater occipital nerve block in MOH. Therefore, this research aims to demonstrate the efficacy of greater occipital nerve block in detoxification of migraine patients with MOH. Patients will be recruited from Headache Clinic at 3 centers in Thailand from February 2026 to January 2028. After recruitment, patients will be randomized into 2 groups at a 1:1 ratio using a block of four, namely group A and B. A 5-mL syringe of 2 mL of lidocaine 2% and 2 mL of methylprednisolone 40 mg/mL (80 mg) will be prepared for each patient in group while a 5-mL syringe of 4 mL normal saline will be prepared for each patient in group B. Monthly headache days, duration, severity, acute medication type and number of usage days and relative headache status according to a 5-point Likert scale will be investigated at the 2 weeks, 1st, 2nd and 3rd month, MIDAS at the end of 3rd month.","conditions":["Migraine Disorders","Medication Overuse Headache","Greater Occipital Nerve Block"],"keywords":["GONB","Nerve Block","Detoxification","MOH","Methylprednisolone","Lidocaine"],"interventions":[{"type":"DRUG","name":"Lidocaine 2% and Methylprednisolone 80 mg"},{"type":"OTHER","name":"Placebo"}],"enrollment":130,"startDate":"2026-05-12","completionDate":"2028-11-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist\n* Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test\n\nExclusion Criteria:\n\n* Patients who have other types of headache disorders other than migraine\n* Patients who have a previous history of allergy to corticosteroid or lidocaine\n* Patients who had previous skull surgery\n* Pregnant women\n* Patients with a history of uncontrolled depression, or psychosis\n* Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection\n* Patients with an increased risk of bleeding or underlying bleeding disorders","locations":[{"facility":"Faculty of Medicine Siriraj Hospital, Mahidol University","city":"Bangkok","state":"Bangkok","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine, Prince of Songkla University","city":"Hat Yai","state":"Changwat Songkhla","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Faculty of Medicine, Chiang Mai University","city":"Chiang Mai","state":"Chiang Mai","country":"Thailand","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pannathat Soontrapa, M.D.","phone":"+6690-568-6388","email":"pannathat.soo@mahidol.ac.th"}],"primaryOutcomes":["Percentage of patients with Medication Overuse Headache (MOH)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["bangkok-thailand","hat-yai-thailand","chiang-mai-thailand"],"enrichment":{"headline":"Not a traditional drug phase: testing Lidocaine 2% and Methylprednisolone 80 mg for Migraine Disorders","inPlainEnglish":"Migraine is among the leading causes of disability worldwide. Inappropriate use of acute medications in the setting of primary headache, particularly migraine can result in a debilitating condition known as medication overuse headache (MOH).","whoItsFor":["Ages 18 Years to 80 Years","Patients who have a diagnosis of migraine with medication overuse headache according to ICHD-3 criteria confirmed by a neurologist","Female patients will be screened for pregnancy planning and married female patients must undergo a urine pregnancy test"],"whoShouldSkip":["Patients who have other types of headache disorders other than migraine","Patients who have a previous history of allergy to corticosteroid or lidocaine","Patients who had previous skull surgery","Patients with a history of uncontrolled depression, or psychosis","Patients who get or plan to get CGRP-targeted therapies or botulinum toxin injection","Patients with an increased risk of bleeding or underlying bleeding disorders"],"whatHappens":"If you join, the listed intervention(s) are Lidocaine 2% and Methylprednisolone 80 mg, or Placebo. The registry lists allocation as randomized. Migraine is among the leading causes of disability worldwide.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 130 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.308Z"},{"nctId":"NCT07569198","title":"Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder (KET-DBT)","officialTitle":"Combining Ketamine With Dialectical Behavioural Therapy (DBT) for Suicidality in Individuals With Treatment-Resistant Depression and Borderline Personality Disorder: A Phase II Randomized, Midazolam-Controlled Clinical Trial (KET-DBT)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Joshua Rosenblat","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is:\n\nDoes IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?\n\nResearchers will compare six IV ketamine infusions and DBT to an active placebo (a look-alike substance that mimics some of ketamine's effects and not others) and DBT to see if IV ketamine with DBT is more effective at reducing SI severity.\n\nParticipants will:\n\n* Complete six infusions of either IV ketamine or IV midazolam\n* Take part in 6 months of DBT (includes both weekly one-on-one sessions, and group sessions, starting week 5 of the trial)\n* Visit the hospital for scheduled in-person visits\n* Join a call or videocall for scheduled remote visits\n* Complete a variety of different mood, cognitive and behavioral assessments","conditions":["Borderline Personality Disorder (BPD)","Treatment-Resistant Major Depressive Disorder","Treatment-resistant Bipolar Depression","Major Depressive Disorder (MDD)","Bipolar Disorder (BD)","Bipolar Disorder I or II","Suicidal Ideation"],"keywords":["Dialectical Behavioural Therapy (DBT)","ketamine","Borderline Personality Disorder","Treatment-Resistant Depression","Bipolar Disorder (BD)","Major Depressive Disorder (MDD)","Suicidality"],"interventions":[{"type":"DRUG","name":"Ketamine Hydrochloride"},{"type":"DRUG","name":"Midazolam Hydrochloride"},{"type":"BEHAVIORAL","name":"Dialectical Behavioral Therapy (DBT)"}],"enrollment":120,"startDate":"2026-07-16","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults between the age of 18 to 70, inclusive;\n2. Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);\n3. Meets DSM-5 criteria for MDD or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);\n4. Current MDE must be moderate to severe, as determined by the MADRS score \\>20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);\n5. No changes in pharmacotherapy for MDD/BD in the last month or changes in psychotherapy in the past month;\n6. Baseline SI as shown by two consecutive MSSI scores \\> 10 two weeks apart.\n\nExclusion Criteria:\n\n1. Past or current history of a psychotic disorder as determined by clinical assessment and MINI;\n2. Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \\> 12) and the MINI;\n3. Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;\n4. Lifetime history of ketamine use disorder or illicit ketamine use.\n5. Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA).\n6. Presence of a relative or absolute contraindication to ketamine or midazolam, including a drug allergy, lifetime history of stroke, uncontrolled hypertension (Systolic BP \\> 160 or Diastolic BP \\> 100), low or labile blood pressure (Systolic BP \\< 100 or Diastolic BP \\< 60), recent (within the past 6 months) myocardial infarction, severe coronary artery disease (ascertained through participant's medical history), or moderate to severe renal (GFR scores ≤ 44) or hepatic impairment (A Child-Pugh score of ≥ 7);\n7. Currently pregnant or breastfeeding or planning on getting pregnant within the first two months of the trial or planning on getting someone else pregnant within the first two months of trial. Participants who are sexually active must agree to use a highly effective contraceptive method (please see exhaustive list in Section 3.6.1);\n8. Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;\n9. Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;\n10. Those engaged in other forms of psychotherapy must be willing to discontinue for the duration of the 6-month DBT intervention (standard for DBT). There should be no changes in psychotherapy 30 days prior to baseline (i.e., Screening Visit 2).","locations":[{"facility":"Toronto Western Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Diana Orsini","phone":"437-882-9458","email":"ket.dbt@uhn.ca"},{"name":"Deep Grewal","phone":"","email":"actu@uhn.ca"}],"primaryOutcomes":["Change in suicidal ideation severity using the Modified Scale for Suicidal Ideation (MSSI)"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":["ketamine"],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Phase 2: testing Ketamine Hydrochloride for Borderline Personality Disorder (BPD)","inPlainEnglish":"The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder. The main question it aims to answer is: Does IV ketamine and DBT produce more rapid and robust improvements in suicidal ideation (SI) severity between baseline and Day 35 compared to IV midazolam and DBT, as measured by changes in the Modified Scale for Suicidal Ideation (MSSI) scores ?","whoItsFor":["Ages 18 Years to 70 Years","Adults between the age of 18 to 70, inclusive;","Meets criteria for BPD, as determined by clinical assessment by a psychiatrist or psychologist and confirmed by the International Personality Disorder Examination (IPDE);","Meets DSM-5 criteria for major depression or BD (I or II), currently experiencing a MDE without psychotic features, as diagnosed by a study psychiatrist or psychologist. Diagnosis will be confirmed using the Mini- International Neuropsychiatric Interview (MINI);","Current MDE must be moderate to severe, as determined by the MADRS score \\>20 with an inadequate response to two or more guideline-concordant treatment trials as defined by the Antidepressant Treatment History Form-Short Form (ATHF- SF);","No changes in pharmacotherapy for major depression/BD in the last month or changes in psychotherapy in the past month;","Baseline SI as shown by two consecutive MSSI scores \\> 10 two weeks apart"],"whoShouldSkip":["Past or current history of a psychotic disorder as determined by clinical assessment and MINI;","Current or recent (within the past 3 months) manic or hypomanic episode as determined by clinical assessment via YMRS (score \\> 12) and the MINI;","Meeting criteria for Moderate to Severe Alcohol or substance use disorders currently or within the past 3 months;","Lifetime history of ketamine use disorder or illicit ketamine use","Acute suicide risk requiring involuntary inpatient treatment under the Mental Health Act (MHA)","Current use of prohibited concomitant medications, including other forms of ketamine or esketamine, high dose daily benzodiazepines (greater than 4 mg lorazepam equivalent daily) or monoamine oxidase inhibitors;","Currently engaged (or completed within the past year) in DBT treatment. NOTE: Individuals who have received only DBT skills training in the past year will be considered eligible to participate;"],"whatHappens":"If you join, the listed intervention(s) are Ketamine Hydrochloride, Midazolam Hydrochloride, or Dialectical Behavioral Therapy (DBT). The registry lists allocation as randomized. The goal of this clinical trial is to learn if intravenous (IV) ketamine with Dialectical Behavioural Therapy (DBT) reduces suicidal ideation in individuals with suicidality who have been diagnosed with Borderline Personality Disorder and either Major Depressive Disorder or Bipolar Disorder.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at Toronto. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.792Z"},{"nctId":"NCT07569640","title":"HFrEF Polypill in Sri Lanka RCT","officialTitle":"Heart Failure With Reduced Ejection Fraction Polypill in Sri Lanka: A Multi-Center Type I Hybrid Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up.\n\nPrimary outcome of the study:\n\n1\\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration\n\nSecondary outcomes of the study:\n\n1. Rate of cardiovascular disease mortality over study duration\n2. Rate of recurrent heart failure hospitalizations over the study duration\n3. Rate of all-cause mortality over the study duration\n4. Change in left ventricular ejection fraction at 12-months and end of study assessed by transthoracic echocardiogram\n5. Change in BNP levels at 12 months and end of study\n6. Change in overall and domain specific health-related quality of life at 12-months and end of study assessed by a translated validated version of the Kansas City Cardiomyopathy Questionnaire (KCCQ-23)\n7. Change in physician-reported New York Heart Association class at 12-months and end of study\n8. Adherence to guideline-directed medical therapy assessed by pill count and MARS-5 questionnaire at baseline, 1-, 6-, 12-months, and end of study. Persistence assessed as continuation of assigned therapy at each follow-up visit. Dose optimization assessed as proportion achieving target doses (Strength 3 of the polypill, or comparable individual GDMT doses in the comparator arm) at 6-, 12-months, and end of study.\n\nSafety outcomes:\n\n1. Proportion of participants with serious adverse events according to Good Clinical Practice guidelines over study duration\n2. Proportion of participants with adverse events of special interest over study duration\n3. Proportion of participants with adverse events leading to HF drug discontinuation over study duration\n4. Mean change from baseline to 12-months and end of study in serum potassium (mEq/L)\n5. Mean change from baseline to 12-months and end of study in serum creatinine (mg/dL)\n\nParticipants will be randomly assigned 1:1 stratified by sex and site to one of two groups, intervention (experimental arm) or usual care (control arm). The intervention group will be given four guideline-recommended medications for heart failure with reduced ejection fraction, combined in one over-encapsulated pill, with three dose strength options. Both groups will be observed over a minimum of 12-months of follow-up to assess key outcomes.","conditions":["Heart Failure With Reduced Ejection Fraction"],"keywords":["HFrEF","Heart Failure","Heart Failure with Reduced Ejection Fraction","South Asia","Sri Lanka","Polypill","type I hybrid-effectiveness"],"interventions":[{"type":"OTHER","name":"Usual Care"},{"type":"DRUG","name":"HFrEF Polypill"}],"enrollment":1672,"startDate":"2026-08-17","completionDate":"2029-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults (≥18 years old)\n2. Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced left ventricular ejection fraction (EF ≤40%)\n3. New York Heart Association Class II, III, or IV symptoms\n\nExclusion Criteria:\n\n1. Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others).\n2. Significant renal impairment (estimated glomerular filtration rate \\<30 mL/min/1.73 m2).\n3. Raised serum potassium \\>5 mEq/L.\n4. Symptomatic hypotension or systolic BP \\<100 mmHg as per the average of last 2 of the 3 measurements at visit 1.\n5. Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1.\n6. History of type 1 diabetes mellitus.\n7. Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly acceptable form of contraception throughout the study (pharmacological or barrier methods).\n8. Concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary physician could interfere with the conduct of the study including outcome assessment.\n9. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.\n10. Participant's responsible physician believes it is not appropriate for participant to participate in the study.\n11. Inability or unwillingness to provide written informed consent.\n12. Involvement in the planning and/or conduct of the study.\n13. Unable to complete study procedures and/or plan to move out of the study site area in the next 12 months.","locations":[{"facility":"National Hospital Kandy","city":"Kandy","state":"Central Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teaching Hospital Anuradhapura","city":"Anuradhapura","state":"North Central Province","country":"Sri Lanka","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Teaching Hospital Kurunegala","city":"Kurunegala","state":"North Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teaching Hospital Jaffna","city":"Jaffna","state":"Northern Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rathnapura Teaching Hospital","city":"Colombo","state":"Ratnapura","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Galle","city":"Galle","state":"Southern Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital of Sri Lanka","city":"Colombo","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital - General Sir John Kotelawala Defence University","city":"Colombo","state":"Western Province","country":"Sri Lanka","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Colombo South Teaching Hospital","city":"Dehiwala","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gampaha District General Hospital","city":"Gampaha","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"District General Hospital Negombo","city":"Negombo","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colombo North Teaching Hospital","city":"Ragama","state":"Western Province","country":"Sri Lanka","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anubha Agarwal, MD MSc","phone":"+1 314-362-1291","email":"anubha@wustl.edu"},{"name":"Asita de Silva, MBBS DPhil FRCP","phone":"+94 11 2961241","email":"asita@kln.ac.lk"}],"primaryOutcomes":["Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["kandy-sri-lanka","anuradhapura-sri-lanka","kurunegala-sri-lanka","jaffna-sri-lanka","colombo-sri-lanka","galle-sri-lanka","dehiwala-sri-lanka","gampaha-sri-lanka","negombo-sri-lanka","ragama-sri-lanka"],"enrichment":{"headline":"Phase 3: testing HFrEF Polypill for Heart Failure With Reduced Ejection Fraction","inPlainEnglish":"The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up. Primary outcome of the study: 1\\) Composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations over study duration Secondary outcomes of the study: 1.","whoItsFor":["Ages 18 Years to any","Adults (≥18 years old)","Diagnosis of heart failure with reduced ejection fraction (HFrEF) including clinical symptoms or clinical signs or natriuretic peptide elevation AND echocardiographic or other evidence of reduced left ventricular ejection fraction (EF ≤40%)","New York Heart Association Class II, III, or IV symptoms"],"whoShouldSkip":["Known contraindication to any of the HFrEF polypill components (e.g., advanced renal disease, bradycardia, allergy, amongst others)","Significant renal impairment (estimated glomerular filtration rate \\<30 mL/min/1.73 m2)","Raised serum potassium \\>5 mEq/L","Symptomatic hypotension or systolic BP \\<100 mmHg as per the average of last 2 of the 3 measurements at visit 1","Symptomatic bradycardia or second or third-degree heart block without a pacemaker on ECG review at visit 1","History of type 1 diabetes mellitus","Women who are pregnant, breastfeeding or of childbearing potential and are not using and do not plan to continue using a highly acceptable form of contraception throughout the study (pharmacological or barrier methods)"],"whatHappens":"If you join, the listed intervention(s) are Usual Care, or HFrEF Polypill. The registry lists allocation as randomized. The aim of this study is to evaluate, in adults with HFrEF in Sri Lanka, the effects of an HFrEF polypill implementation strategy on the composite rate of cardiovascular disease mortality and recurrent heart failure hospitalizations, compared with usual care over a minimum of 12-months of follow-up.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,672 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.953Z"},{"nctId":"NCT07569913","title":"A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test","officialTitle":"A Study to Evaluate the Performance, and Usability of TruPlex HIV/HepB/Syphilis Rapid Test by Trained Personnel at Near-Patient and Point-of-Care Settings","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"bioLytical Laboratories","sponsorClass":"INDUSTRY","summary":"To evaluate the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to evaluate the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.","conditions":["HIV1 Infection","HIV 2 Infection","Syphilis Infection","Hepatitis B Infection"],"keywords":["TruPlex HIV/HepB/Syphilis Rapid Test"],"interventions":[{"type":"DEVICE","name":"TruPlex HIV/HepB/Syphilis Rapid Test"}],"enrollment":500,"startDate":"2026-05-14","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 years of age or older\n* Subject is able to provide and willing to sign and date the Informed Consent Form\n* Subject is able to complete the required testing on the allocated testing day.\n* Subject is able to speak/read/write English or a translator is available\n* Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons:\n\n  * At risk for any one of the target diseases\n  * Having signs or symptoms indicative of the target diseases\n  * Routine testing\n  * Note: Subjects who are pregnant and re-infected are eligible to participate\n* Unknown HIV or known HIV positive status with less than 12 months of Anti-Retroviral Treatment (ART).\n* Subject is willing to provide the fingerstick blood sample(s) and whole blood samples collected through venous blood draw (approximately 16 ml) required for the study.\n* Subject willing to participate in the study site's standard of care counselling and testing program and receive the study site's standard of care test results\n\nExclusion Criteria:\n\n* Subject has a bleeding disorder\n* Subject is currently undergoing Syphilis treatment\n* Subject has received any experimental HIV vaccine\n* Subject received HBV vaccine within the last 7 days\n* Known HIV positive subjects and currently on ART for 12 months or longer\n* Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome.","locations":[{"facility":"St Vincent's Hospital (Melbourne), Dept. of Gastroenterology","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ana Subramanian","phone":"16042046784","email":"asubramanian@biolytical.com"},{"name":"Patrick Diaz","phone":"16042046784","email":"pdiaz@biolytical.com"}],"primaryOutcomes":["Performance Evaluation"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["melbourne-australia"],"enrichment":{"headline":"Not a traditional drug phase: TruPlex HIV/HepB/Syphilis Rapid Test for HIV1 Infection","inPlainEnglish":"To measure the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings. Additionally, to measure the usability of the TruPlex test through: structured usability assessments, via a questionnaire, completed by trained operators in point-of-care settings.","whoItsFor":["Ages 18 Years to any","18 years of age or older","Subject is able to complete the required testing on the allocated testing day","Subject is able to speak/read/write English or a translator is available","Subject is getting tested for HIV, and/or Syphilis, and/or Hepatitis B for one or more of the following reasons:","At risk for any one of the target diseases","Having signs or symptoms indicative of the target diseases","Note: Subjects who are pregnant and re-infected are eligible to participate"],"whoShouldSkip":["Subject has a bleeding disorder","Subject is currently undergoing Syphilis treatment","Subject has received any experimental HIV vaccine","Subject received HBV vaccine within the last 7 days","Known HIV positive subjects and currently on ART for 12 months or longer","Any condition which, in the opinion of the Investigator, would make the participant unsuitable or unsafe for enrolment or could interfere with the completion of study assessment, consent form and questionnaire etc. or bias the study outcome"],"whatHappens":"If you join, the listed intervention(s) are TruPlex HIV/HepB/Syphilis Rapid Test. The registry lists allocation as na. To measure the clinical performance of each analyte (HIV, HBsAg, and Syphilis) on the TruPlex HIV/HepB/Syphilis Rapid Test (TruPlex Test) using capillary blood (fingerstick), EDTA whole blood, EDTA-plasma, and SST-serum samples collected by trained operators at point-of-care settings.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 500 people at Melbourne. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.535Z"},{"nctId":"NCT07570173","title":"A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)","officialTitle":"A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer. This trial will compare MK-1045 to a standard immunotherapy called blinatumomab. The goals of this trial are to learn if more people who receive MK-1045 have no cancer cells in their bone marrow compared to people who receive blinatumomab and if people who receive MK-1045 live longer compared to people who receive blinatumomab.","conditions":["B-cell Acute Lymphoblastic Leukemia"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-1045"},{"type":"BIOLOGICAL","name":"Blinatumomab"},{"type":"DRUG","name":"Acetaminophen"},{"type":"DRUG","name":"Diphenhydramine"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Tocilizumab"},{"type":"DRUG","name":"Siltuximab"},{"type":"DRUG","name":"Avtozma"},{"type":"DRUG","name":"Tyenne"}],"enrollment":340,"startDate":"2026-05-18","completionDate":"2033-10-18","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow\n* Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment\n* Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment\n* Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline\n* Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\n* Has Burkitt's leukemia\n* History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis\n* Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded\n* History of serious cardiovascular and cerebrovascular diseases.\n* HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Received prior treatment with blinatumomab within 12 weeks for Part 1 and 24 weeks for Part 2 before the first dose of study intervention (individuals known to be refractory or intolerant to blinatumomab are to be excluded). Refractory to blinatumomab is defined as failure to achieve a response after at least 2 cycles of previous blinatumomab treatment\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Isolated extramedullary disease (EMD)\n* Active autoimmune disease unrelated to ALL that has required systemic treatment in the past 2 years or history of autoimmune disease with potential CNS involvement\n* Active infection requiring systemic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications","locations":[{"facility":"Princess Margaret Cancer Center ( Site 0102)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rigshospitalet ( Site 0802)","city":"Copenhagen","state":"Capital Region","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aarhus Universitetshospital. Hæmatologisk afdeling ( Site 0804)","city":"Aarhus Nord","state":"Central Jutland","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Odense Universitetshospital ( Site 0801)","city":"Odense C","state":"Region Syddanmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Bordeaux Haut-Leveque ( Site 4103)","city":"Pessac","state":"Gironde","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Saint-Louis ( Site 4100)","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelismos General Hospital of Athens ( Site 5100)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Athens \"Laiko\" ( Site 5101)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Athens \"Laiko\" ( Site 5104)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University General Hospital ''Attikon'' - General Hospital of West Attica \"H AGIA VARVARA\" ( Site 5102)","city":"Chaïdári","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of Ioannina ( Site 5103)","city":"Ioannina","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0903)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haddasah Medical Center ( Site 0900)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0902)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center. ( Site 0904)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 1002)","city":"Bergamo","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Universitario Agostino Gemelli ( Site 1003)","city":"Rome","state":"Roma","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Komagome Hospital ( Site 2106)","city":"Bunkyo","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toranomon Hospital ( Site 2101)","city":"Minato","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboud UMC ( Site 2003)","city":"Geert Grooteplein-Zuid 8","state":"Gelderland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam UMC ( Site 2001)","city":"Amsterdam","state":"North Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erasmus Medisch Centrum ( Site 2000)","city":"Rotterdam","state":"South Holland","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia (ICO) - Badalona ( Site 3001)","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Universidad de Navarra ( Site 3006)","city":"Pamplona","state":"Navarre","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Central de Asturias ( Site 3008)","city":"Oviedo","state":"Principality of Asturias","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL CLINICO DE VALENCIA ( Site 3005)","city":"Valencia","state":"Valenciana, Comunitat","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Marañón ( Site 3003)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID ( Site 3009)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Salamanca ( Site 3002)","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Karolinska Universitetssjukhuset ( Site 4002)","city":"Stockholm","state":"Stockholm County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2","Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1","Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1","Overall Survival (OS) in Study Part 2"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":[],"locationSlugs":["toronto-canada","copenhagen-denmark","aarhus-nord-denmark","odense-c-denmark","pessac-france","paris-france","athens-greece","cha-d-ri-greece","ioannina-greece","haifa-israel","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","bergamo-italy","rome-italy","bunkyo-japan","minato-japan","geert-grooteplein-zuid-8-netherlands","amsterdam-netherlands","rotterdam-netherlands","badalona-spain","pamplona-spain","oviedo-spain","valencia-spain","madrid-spain","salamanca-spain","stockholm-sweden"],"enrichment":{"headline":"Phase 2 / Phase 3: testing MK-1045 for B-cell Acute Lymphoblastic Leukemia","inPlainEnglish":"Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045. MK-1045 is an immunotherapy, which is a treatment that helps the immune system fight cancer.","whoItsFor":["Ages 12 Years to any","Has a confirmed diagnosis of relapsed/refractory (R/R) B-precursor acute lymphoblastic leukemia (ALL) with 5% or more lymphoblasts in the bone marrow","Has CD19+ disease, confirmed by local flow cytometry and/or immunohistochemistry testing at the time of enrollment","Has Philadelphia-negative disease, confirmed by testing, at the time of enrollment","Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline","Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)"],"whoShouldSkip":["Has Burkitt's leukemia","History or presence of clinically relevant central nervous system (CNS) diseases such as epilepsy, hemorrhagic/ischemic stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, and psychosis","Has active acute graft versus host disease (GvHD) or chronic GvHD. NOTE: Participants who have received CNI for GvHD within 4 weeks before the first dose of study intervention are also excluded","History of serious cardiovascular and cerebrovascular diseases","HIV-infection with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention","Known additional malignancy that is progressing or has required active treatment within the past 2 years"],"whatHappens":"If you join, the listed intervention(s) are MK-1045, Blinatumomab, or Acetaminophen. The registry lists allocation as randomized. Researchers are looking for new ways to treat people with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) that is CD19 positive using a medicine called MK-1045.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 340 people at 30 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.810Z"},{"nctId":"NCT07570654","title":"Redefine Study: A Study Evaluating the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","officialTitle":"A Phase 2b/3, Multicentre, Randomised, Double-blind, Controlled Trial, With an Open Label Extension, to Investigate the Efficacy, Safety, and Tolerability of COMP360 in Participants With Post-traumatic Stress Disorder","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"COMPASS Pathways","sponsorClass":"INDUSTRY","summary":"The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.","conditions":["PTSD - Post Traumatic Stress Disorder","PTSD","PTSD Symptoms","PTSD, Post Traumatic Stress Disorder"],"keywords":["COMP360","psilocybin","Redefine","PTSD","trauma"],"interventions":[{"type":"DRUG","name":"COMP360 psilocybin"}],"enrollment":300,"startDate":"2026-09-14","completionDate":"2028-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 years or older\n* Diagnosed with PTSD at least 6 months ago\n\nExclusion Criteria:\n\n\\- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions","locations":[{"facility":"AZ","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CA","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CA","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CA","city":"Moorpark","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FL","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FL","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IL","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MA","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MN","city":"Eden Prairie","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NE","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NV","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NY","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NY","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OH","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TX","city":"Carrollton","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC","city":"Kamloops","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BC","city":"North Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"www.redefineptsdstudy.com Redefine Study Call Center","phone":"202-459-9258","email":"TheRedefineStudy@compasspathways.com"}],"primaryOutcomes":["COMP360 25 mg versus COMP360 1 mg change from Baseline to Week 8 in CAPS-5 total severity score"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":["psilocybin"],"locationSlugs":["tucson-arizona","irvine-california","los-angeles-california","moorpark-california","miami-florida","orlando-florida","chicago-illinois","boston-massachusetts","eden-prairie-minnesota","lincoln-nebraska","las-vegas-nevada","new-york-new-york","the-bronx-new-york","north-canton-ohio","carrollton-texas","kamloops-canada","north-vancouver-canada"],"enrichment":{"headline":"Phase 2 / Phase 3: testing COMP360 psilocybin for PTSD - Post Traumatic Stress Disorder","inPlainEnglish":"The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team. COMP360 is a lab-made form of the naturally occurring chemical compound psilocybin.","whoItsFor":["Ages 18 Years to any","Diagnosed with PTSD at least 6 months ago"],"whoShouldSkip":["\\- Diagnosed with certain psychiatric conditions such as bipolar disorder, schizophrenia, OCD, anorexia, or other conditions"],"whatHappens":"If you join, the listed intervention(s) are COMP360 psilocybin. The registry lists allocation as randomized. The Redefine Study (COMP202) is testing COMP360 to see if it may reduce post-traumatic stress disorder (PTSD) symptoms when administered alongside monitoring and support from a trained study team.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 300 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.407Z"},{"nctId":"NCT07570719","title":"Community-based Screening for Alzheimer's Disease","officialTitle":"Stratified Screening of Blood Biomarkers for Alzheimer's Disease: a Prospective, Real World, Community-based Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Kuang XiaoJun","sponsorClass":"OTHER","summary":"The goal of this prospective, multicenter, observational cohort study is to evaluate the screening performance of blood-based biomarkers for Alzheimer's disease (AD) in a real-world community screening setting, and to establish the population baseline levels and reference intervals of these biomarkers in Chinese older adults.\n\nThe main questions it aims to answer is:\n\nWhat is the clinical screening value of blood biomarkers (phosphorylated tau 217 to amyloid β 42 ratio \\[pTau217/Aβ42\\] and glial fibrillary acidic protein \\[GFAP\\]) for AD among community-dwelling older adults? Eligible study participants will be randomly enrolled from community-dwelling older adults undergoing routine physical examinations and outpatient clinic attendees. All enrolled participants will undergo AD screening via blood biomarker testing. Participants with positive blood biomarker results (defined as abnormal pTau217/Aβ42 ratio and/or GFAP levels) will further complete a full battery of cognitive scale assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Activities of Daily Living (ADL) scale, and 17-item Hamilton Depression Rating Scale (HAMD-17). In addition, 15% of participants with negative blood biomarker results, selected via random sampling, will also complete the same cognitive scale assessments.","conditions":["Alzheimer's Disease(AD)","Mild Cognitive Impairment (MCI)","Cognitive Impairment"],"keywords":["Alzheimer's disease","Cognitive Impairment","Screening","Blood biomarker"],"interventions":[{"type":"OTHER","name":"No study-specific intervention"}],"enrollment":3000,"startDate":"2026-05-27","completionDate":"2027-03-31","sex":"ALL","minAge":"60 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 60-80 years\n* Capable of normal communication and able to complete the questionnaire\n\nExclusion Criteria:\n\n* Severe mental disorders\n* Severe visual, auditory, comprehension or mobility impairments\n* Current participation in other health intervention clinical studies\n* Severe renal insufficiency, heart failure, cerebrovascular disease, anemia, hyperthyroidism, hypothyroidism\n* Multiple cerebral infarctions, severe white matter hyperintensities, history of cerebral hemorrhage, current anticoagulant use, MRI abnormalities (cortical iron deposition, cerebral contusion)\n* Unable to comply with study procedures with no legal guardian","locations":[{"facility":"Fengcheng Community Health Service Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fengpu Community Health Service Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qingcun Community Health Service Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xidu Community Health Service Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaojun Kuang, PhD","phone":"021-57426172","email":"xj_kuang@126.com"}],"primaryOutcomes":["Blood biomarkers （pTau217、Aβ42、GFAP）"],"hasResults":false,"conditionSlugs":["alzheimer","als","depression"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: No study-specific intervention for Alzheimer's Disease(AD)","inPlainEnglish":"The goal of this prospective, multicenter, watch-and-measure (no experimental treatment required) cohort study is to measure the screening performance of blood-based biomarkers for Alzheimer's disease (AD) in a real-world community screening setting, and to establish the population baseline levels and reference intervals of these biomarkers in Chinese older adults. The main questions it aims to answer is: What is the clinical screening value of blood biomarkers (phosphorylated tau 217 to amyloid β 42 ratio \\[pTau217/Aβ42\\] and glial fibrillary acidic protein \\[GFAP\\]) for AD among community-dwelling older adults?","whoItsFor":["Ages 60 Years to 80 Years","Capable of normal communication and able to complete the questionnaire"],"whoShouldSkip":["Severe mental disorders","Severe visual, auditory, comprehension or mobility impairments","Current participation in other health intervention clinical studies","Severe renal insufficiency, heart failure, cerebrovascular disease, anemia, hyperthyroidism, hypothyroidism","Multiple cerebral infarctions, severe white matter hyperintensities, history of cerebral hemorrhage, current anticoagulant use, MRI abnormalities (cortical iron deposition, cerebral contusion)","Unable to comply with study procedures with no legal guardian"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at 4 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.326Z"},{"nctId":"NCT07571096","title":"Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia","officialTitle":"Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome Complicated With Thrombophilia","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Guangdong Women and Children Hospital","sponsorClass":"OTHER","summary":"This observational case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and/or protein S levels in participants with PCOS. The results are expected to provide evidence for risk stratification and individualized management in this population.","conditions":["Polycystic Ovary Syndrome (PCOS)","Thrombophilia"],"keywords":[],"interventions":[],"enrollment":100,"startDate":"2025-03-04","completionDate":"2026-08-01","sex":"FEMALE","minAge":"14 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female participants aged 14 to 45 years\n* Diagnosis of polycystic ovary syndrome (PCOS)\n* For adult participants, PCOS diagnosed according to the 2023 international evidence-based guideline. After exclusion of related disorders, diagnosis is based on ovulatory dysfunction and/or irregular menstrual cycles together with clinical hyperandrogenism, biochemical hyperandrogenism, or polycystic ovarian morphology on ultrasound where appropriate\n* For adolescent participants, PCOS diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and/or irregular menstrual cycles and clinical or biochemical hyperandrogenism are required\n* Irregular menstrual cycles are defined as follows: more than 1 year and less than 3 years after menarche, menstrual cycles shorter than 21 days or longer than 45 days; more than 3 years after menarche to perimenopause, menstrual cycles shorter than 21 days or longer than 35 days, or fewer than 8 cycles per year; any cycle longer than 90 days more than 1 year after menarche; or primary amenorrhea by age 15 years or more than 3 years after thelarche\n* No use within 3 months before blood sampling of anticoagulant drugs, procoagulant drugs, oral contraceptives, or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function\n\nExclusion Criteria:\n\n* Confirmed pregnancy\n* Hematologic disease\n* History of malignant tumor\n* Use of medications within 12 weeks before enrollment that may interfere with study assessments\n* Disorders that may cause hyperandrogenism or ovulatory dysfunction, including congenital adrenal hyperplasia, Cushing syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, or primary ovarian insufficiency\n* Disorders that may affect protein C or protein S levels, including antiphospholipid syndrome, liver disease, or tumor-related conditions\n* In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS","locations":[{"facility":"Guangdong Women and Children Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Decreased protein C and/or protein S levels"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Construction of a Multi-dimensional Risk Assessment System: a Clinical Study of Polycystic Ovary Syndrome C…","inPlainEnglish":"This watch-and-measure (no experimental treatment required) case-control study aims to develop a multidimensional risk assessment model for thrombophilia-related abnormalities in females with polycystic ovary syndrome (PCOS). The study will analyze endocrine, metabolic, and genetic factors associated with decreased protein C and/or protein S levels in participants with PCOS.","whoItsFor":["Ages 14 Years to 45 Years","Women only","Female participants aged 14 to 45 years","Diagnosis of polycystic ovary syndrome (PCOS)","For adolescent participants, PCOS diagnosed according to adolescent-specific recommendations. After exclusion of related disorders, both ovulatory dysfunction and/or irregular menstrual cycles and clinical or biochemical hyperandrogenism are required","No use within 3 months before blood sampling of anticoagulant drugs, procoagulant drugs, oral contraceptives, or other medications that may affect sex hormones, insulin, glucose metabolism, or coagulation function"],"whoShouldSkip":["Confirmed pregnancy","Hematologic disease","History of malignant tumor","Use of medications within 12 weeks before enrollment that may interfere with study assessments","Disorders that may cause hyperandrogenism or ovulatory dysfunction, including congenital adrenal hyperplasia, Cushing syndrome, functional hypothalamic amenorrhea, thyroid disease, hyperprolactinemia, or primary ovarian insufficiency","Disorders that may affect protein C or protein S levels, including antiphospholipid syndrome, liver disease, or tumor-related conditions","In adolescents, polycystic ovarian morphology alone will not be used to establish the diagnosis of PCOS"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Guangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.795Z"},{"nctId":"NCT07571109","title":"AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea","officialTitle":"Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Participants With Overweight or Obesity, and Obstructive Sleep Apnoea Treated With Positive Airway Pressure (AMAZE 4)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and which treatment participants get is decided by chance.","conditions":["Obesity","Overweight","Obstructive Sleep Apnoea"],"keywords":[],"interventions":[{"type":"DRUG","name":"NNC0487-0111"},{"type":"DRUG","name":"Placebo (matched to NNC0487-0111)"}],"enrollment":300,"startDate":"2026-05-05","completionDate":"2028-06-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Male or female (sex at birth)\n* Age 18 years or above at the time of signing informed consent\n* Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening\n\nKey Exclusion Criteria:\n\n* Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening\n* History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records\n* Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy\n* Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence\n* Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening","locations":[{"facility":"Dignity Health, Mercy Gilbert","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Essence MD Research","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palm Beach Research Center","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuroTrials Research, Inc.","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians Research Associates","city":"Lawrenceville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Research Center, Inc","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weil Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lillestol Research LLC","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTI Clinical Research Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Associates of Central PA, LLC","city":"DuBois","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bogan Sleep Consultants, LLC","city":"Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Neurology Epilepsy and Sleep Center ANESC","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biorhythms Center for Integrative Sleep Medicine","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Pulm Med Res Network","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sleep Therapy Research Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tricoastal Sleep Center","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rainier Clin Res Ctr Inc","city":"Renton","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Clinical Research Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woolcock Institute","city":"Macquarie Park","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Sunshine Coast - Vitality Village","city":"Birtinya","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mater Research - RIO Clinical Trials Unit","city":"South Brisbane","state":"Queensland","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nightingale Research Adelaide","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Western Australia - Centre for Sleep Science","city":"Crawley","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital-Endocrinology","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanfang Hospital, Southern Medical University-Department of Psychiatry and Psychology","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen People's Hospital-Sleep Medicine Department","city":"Shenzhen","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science and Technology-Endocrinology","city":"Luoyang","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanjing Medical University-Endocrinology","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital-Respiratory","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Siteworks GmbH Bochum","city":"Bochum","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wendisch - 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There are 2 study treatments in this study taken as injections under the skin once a week.","whoItsFor":["Ages 18 Years to any","Male or female (sex at birth)","Previously diagnosed moderate-to-severe OSA with an AHI ≥ 15, as diagnosed with polysomnography (PSG), home sleep apnoea test (HSAT), or other method that meets local guidelines prior to screening"],"whoShouldSkip":["Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening","History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records","Any planned or previous surgery within 90 days prior to screening for sleep apnoea, including septoplasty, turbinoplasty, or other ear, nose, and throat surgeries, including tonsillectomy and adenoidectomy","Significant craniofacial abnormalities that may affect breathing at baseline, for example Treacher Collins syndrome and Pierre Robin Sequence","Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonist (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment) or amylin analogues before screening"],"whatHappens":"If you join, the listed intervention(s) are NNC0487-0111, or Placebo (matched to NNC0487-0111). The registry lists allocation as randomized. This study is being done to look at the how well it works and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 92 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.952Z"},{"nctId":"NCT07571161","title":"Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease","officialTitle":"A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).\n\nThe study drug will be administered intravenously (IV) (into a vein in the arm).\n\nThe study will last up to approximately 156 weeks, excluding screening.","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Donanemab"},{"type":"DRUG","name":"Placebo"}],"enrollment":140,"startDate":"2026-04-30","completionDate":"2030-04","sex":"ALL","minAge":"55 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)\n* Clinical Dementia Rating-Global Score (CDR-GS) of 0\n* A plasma P-tau result consistent with amyloid pathology\n* A reliable study partner who:\n\n  * Provides written informed consent to participate in the study in their role\n  * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities\n  * Is of legal age (18 years of age or older) to consent\n  * Is available to conduct functional scales\n* Have adequate literacy, vision, and hearing for neuropsychological testing\n\nExclusion Criteria:\n\n* Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition\n* Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer\n* Have received active or passive immunization against amyloid beta (Aβ) in any other study\n* Have current or prior use of prescription medications for treatment of MCI or AD\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants\n* Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening","locations":[{"facility":"Peking University Third Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Jilin University","city":"Changchun","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital Central South University","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Provincial People's Hospital","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"2nd Affiliated Hospital Chongqing Medical University","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fujian Medical University Union Hospital","city":"Fuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anhui Provincial Hospital","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Jiaxing","city":"Jiaxing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanchang University","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Official Hospital","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Brain Hospital","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Hospital of Nanjing Medical University","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Nanyang Medical College","city":"Nanyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Sixth People's Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pudong New Area People's Hospital Shanghai","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"ShenZhen People's Hospital","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Hebei Medical University","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University General Hospital","city":"Tianjin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaanxi provincial people's hospital","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Xianyang Hospital of Yan'an University","city":"Xianyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qinghai Provincial People's Hospital","city":"Xining","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zigong First People's Hospital","city":"Zigong","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zunyi First People's Hospital","city":"Zunyi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["beijing-china","changchun-china","changsha-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","hefei-china","jiaxing-china","jinan-china","nanchang-china","nanjing-china","nanyang-china","shanghai-china","shenzhen-china","shijiazhuang-china","tianjin-china","wenzhou-china","xian-china","xianyang-china","xining-china","zigong-china","zunyi-china"],"enrichment":{"headline":"Phase 3: testing Donanemab for Alzheimer Disease","inPlainEnglish":"The main purpose of this study is to measure the effects of donanemab (LY3002813) versus dummy treatment (placebo) in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD). The study drug will be administered intravenously (IV) (into a vein in the arm).","whoItsFor":["Ages 55 Years to 80 Years","A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)","Clinical Dementia Rating-Global Score (CDR-GS) of 0","A plasma P-tau result consistent with amyloid pathology","A reliable study partner who:","Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities","Is of legal age (18 years of age or older) to consent","Is available to conduct functional scales"],"whoShouldSkip":["Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition","Have received active or passive immunization against amyloid beta (Aβ) in any other study","Have current or prior use of prescription medications for treatment of MCI or AD","Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants"],"whatHappens":"If you join, the listed intervention(s) are Donanemab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to measure the effects of donanemab (LY3002813) versus dummy treatment (placebo) in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 140 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.499Z"},{"nctId":"NCT07571174","title":"A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis","officialTitle":"A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4256984"}],"enrollment":32,"startDate":"2026-05-14","completionDate":"2029-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study.\n\nInclusion Criteria:\n\n* Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.\n\nExclusion Criteria:\n\n* The participant has conditions that preclude a lumbar puncture (LP), such as:\n\n  * A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.\n  * Allergy to local anesthetics, such as lidocaine or its derivatives.\n  * A local infection at the intended site of the LP.\n  * Less than 100 giga per liter \\[(\\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or\n  * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.","locations":[{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Heritage Medical Research Clinic","city":"Calgary","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital - London Health Sciences Centre","city":"London","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Research Institute","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein","city":"Lübeck","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Rostock","city":"Rostock","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari de Bellvitge","city":"L'Hospitalet de Llobregat","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari i Politecnic La Fe","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"3176154559","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["leuven-belgium","calgary-canada","london-canada","montreal-canada","toronto-canada","l-beck-germany","rostock-germany","ulm-germany","utrecht-netherlands","lhospitalet-de-llobregat-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing LY4256984 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"The main purpose of this study is to assess the long-term whether it is safe and how hard side effects are to live with of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.","whoItsFor":["Ages 18 Years to 80 Years","Participants must meet eligibility criteria in the \\[L0U-MC-OLMP\\] screening protocol before entry into the treatment study","Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA"],"whoShouldSkip":["The participant has conditions that preclude a lumbar puncture (LP), such as:","A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP","Allergy to local anesthetics, such as lidocaine or its derivatives","A local infection at the intended site of the LP","Less than 100 giga per liter \\[(\\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\\] platelets or clinically significant coagulation abnormality or significant active bleeding, or","Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted"],"whatHappens":"If you join, the listed intervention(s) are LY4256984. The registry lists allocation as na. The main purpose of this study is to assess the long-term whether it is safe and how hard side effects are to live with of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 32 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.622Z"},{"nctId":"NCT07571200","title":"A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)","officialTitle":"A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4256984"}],"enrollment":32,"startDate":"2026-05-14","completionDate":"2029-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria:\n\n* Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.\n\n  * Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol.\n  * Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.\n\nExclusion Criteria:\n\n* During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.\n* During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.\n* During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.","locations":[{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Heritage Medical Research Clinic","city":"Calgary","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Hospital - London Health Sciences Centre","city":"London","state":"","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Research Institute","city":"Toronto","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein","city":"Lübeck","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Rostock","city":"Rostock","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari de Bellvitge","city":"L'Hospitalet de Llobregat","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari i Politecnic La Fe","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["leuven-belgium","calgary-canada","london-canada","montreal-canada","toronto-canada","l-beck-germany","rostock-germany","ulm-germany","utrecht-netherlands","lhospitalet-de-llobregat-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing LY4256984 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174).","whoItsFor":["Ages 18 Years to 80 Years","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll","Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS","Note 1: To be considered a \"completer\" of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol","Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant"],"whoShouldSkip":["During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator","During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator"],"whatHappens":"If you join, the listed intervention(s) are LY4256984. The registry lists allocation as na. Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 32 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.622Z"},{"nctId":"NCT07572032","title":"Delayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected Aetiology (DELAY-HF), Pilot Study","officialTitle":"DELayed Initiation of ARNI and SGLT2i in Heart Failure With Corrected aetiologY (DELAY-HF), Pilot Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Kyungsub Song","sponsorClass":"OTHER","summary":"In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair/replacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators. In this clinical setting, a substantial proportion of patients may not require the full set of guideline-directed medical therapies routinely prescribed for chronic HFrEF. The purpose of this study is to determine whether ARNI (angiotensin receptor-neprilysin inhibitor) and SGLT2 inhibitors are truly necessary in patients whose left ventricular function recovers spontaneously after treatment of a correctable cause of heart failure.\n\nThe DELAY-HF trial (DELayed initiation of ARNI and SGLT2i in heart failure with corrected aetiologY) is a multicentre, randomised, open-label pilot trial with blinded end-point assessment (PROBE design) evaluating the safety and feasibility of a delayed-initiation strategy of ARNI and SGLT2i, compared with immediate initiation, in patients with heart failure whose underlying cause has been completely corrected by surgical or procedural intervention. A total of 80 patients (40 per arm) will be enrolled at four centres in South Korea.\n\nAdults with a preoperative left ventricular ejection fraction (LVEF) ≤40% who have undergone successful correction of a reversible cause of heart failure-either revascularization (PCI or CABG) for ischemic cardiomyopathy or valvular surgery (including TAVI) for left-sided valvular heart disease causing volume overload-will be randomized 1:1 to (1) delayed initiation, in which ARNI/SGLT2i are withheld for 6 months and started only in patients whose LVEF remains ≤40% at the 6-month assessment, versus (2) immediate guideline-directed medical therapy (GDMT) including ARNI/SGLT2i started shortly after the corrective procedure. All patients are followed for 12 months.\n\nThe primary outcome is the absolute change in LVEF from baseline to 12 months. The between-group difference (delayed minus immediate) will be reported as a point estimate with a two-sided 95% confidence interval and evaluated against a pre-specified decision criterion (lower confidence limit above -5 percentage points). As a pilot trial, DELAY-HF is not powered for a confirmatory non-inferiority test; it aims to estimate the standard deviation of the primary outcome, recruitment and dropout rates, the rescue-therapy rate and safety data needed to design a subsequent confirmatory trial. Key secondary outcomes include cardiovascular and all-cause mortality, heart failure hospitalisation, additional echocardiographic indices, NT-proBNP, KCCQ-12 score, 6-minute walk distance, feasibility metrics, and a cost-effectiveness analysis.\n\nBy comparing these two strategies, this pilot trial will provide preliminary estimates of the incremental contribution of ARNI and SGLT2i-to further LVEF recovery and to clinical outcomes-in patients who have already demonstrated spontaneous improvement in cardiac function after correction of the underlying cause, and will inform the design of a subsequent confirmatory trial addressing whether these agents are truly necessary in this population.","conditions":["Heart Failure Due to Coronary Artery Disease","Valvular Cardiomyopathy","Heart Failure"],"keywords":["Heart failure","Recovered ejection fraction","ARNI (Angiotensin receptor-neprilysin inhibitor)","SGLT2 inhibitor","Valvular heart disease","Ischemic cardiomyopathy"],"interventions":[{"type":"DRUG","name":"Sacubitril / Valsartan"},{"type":"DRUG","name":"SGLT-2 inhibitor"},{"type":"DRUG","name":"Sacubitril / Valsartan"},{"type":"DRUG","name":"SGLT2 Inhibition"}],"enrollment":80,"startDate":"2026-05-20","completionDate":"2028-05-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Preoperative left ventricular ejection fraction (LVEF) ≤ 40% on echocardiography.\n* Successful surgical or procedural correction of a correctable underlying cause of heart failure: Valvular heart disease: mitral valve surgery, aortic valve surgery, transcatheter aortic valve implantation (TAVI), or tricuspid valve surgery, OR Ischemic cardiomyopathy: complete revascularization by coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI).\n* Enrollment between 3 months before and 10 days after the corrective procedure.\n* Hemodynamically stable post-operative state with NYHA class I, defined at the time of randomization as: Systolic blood pressure ≥ 90 mmHg sustained for at least 6 hours; No up-titration of intravenous diuretics within the preceding 6 hours; No use of intravenous vasodilators within the preceding 6 hours; No use of intravenous inotropes within the preceding 24 hours; Heart rate 50-110 bpm and no clinical signs of volume overload.\n* Patients receiving ARNI or SGLT2 inhibitors prior to enrollment must complete a 1-week washout period before randomization.\n\nProvision of written informed consent.\n\nExclusion Criteria:\n\n* Prior history of sustained ventricular tachycardia or ventricular fibrillation.\n* Greater-than-moderate paravalvular leak or residual mitral regurgitation after aortic or mitral valve surgery.\n* Incomplete revascularization in patients with coronary artery disease (residual significant disease in any major coronary territory: LAD, LCX, or RCA).\n* Graft occlusion documented on coronary CT angiography after CABG. Planned pregnancy during the study period.\n* Uncontrolled hypertension on medical therapy (systolic blood pressure \\> 160 mmHg).\n* Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m².\n* Inability to tolerate ARNI, defined as inability to take sacubitril/valsartan 25 mg twice daily (e.g., due to symptomatic hypotension, history of angioedema, or bilateral renal artery stenosis).\n* Inability to tolerate SGLT2 inhibitors (e.g., type 1 diabetes mellitus or history of recurrent diabetic ketoacidosis).\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or follow-up.","locations":[{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"Daegu","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ajou University Hospital","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"Seoul","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kyungsub Song, MD","phone":"82)053-258-7307","email":"chest.songks@gmail.com"}],"primaryOutcomes":["Change in left ventricular ejection fraction (LVEF) at 12 months"],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["daegu-south-korea","seongnam-si-south-korea","suwon-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 4: testing Sacubitril / Valsartan for Heart Failure Due to Coronary Artery Disease","inPlainEnglish":"In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair/replacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators. In this clinical setting, a substantial proportion of patients may not require the full set of guideline-directed medical therapies routinely prescribed for chronic HFrEF.","whoItsFor":["Ages 18 Years to any","Preoperative left ventricular ejection fraction (LVEF) ≤ 40% on echocardiography","Enrollment between 3 months before and 10 days after the corrective procedure","Patients receiving ARNI or SGLT2 inhibitors prior to enrollment must complete a 1-week washout period before randomization"],"whoShouldSkip":["Prior history of sustained ventricular tachycardia or ventricular fibrillation","Greater-than-moderate paravalvular leak or residual mitral regurgitation after aortic or mitral valve surgery","Incomplete revascularization in patients with coronary artery disease (residual significant disease in any major coronary territory: LAD, LCX, or RCA)","Graft occlusion documented on coronary CT angiography after CABG. Planned pregnancy during the study period","Uncontrolled hypertension on medical therapy (systolic blood pressure \\> 160 mmHg)","Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m²","Inability to tolerate ARNI, defined as inability to take sacubitril/valsartan 25 mg twice daily (e.g., due to symptomatic hypotension, history of angioedema, or bilateral renal artery stenosis)"],"whatHappens":"If you join, the listed intervention(s) are Sacubitril / Valsartan, SGLT-2 inhibitor, or Sacubitril / Valsartan. The registry lists allocation as randomized. In patients with heart failure due to a reversible underlying cause-such as valvular heart disease or coronary artery disease-surgical or procedural correction of the underlying lesion (valve repair/replacement, TAVI, PCI, or CABG) frequently leads to spontaneous recovery of cardiac function, even without neurohormonal modulators.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 80 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.619Z"},{"nctId":"NCT07572136","title":"Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)","officialTitle":"Phase I Dose Escalation Study of Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-cell Acute Lymphoblastic Leukemia (B-ALL)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nB-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat. The mutation causes cancer cells to make too much of a protein called thymic stromal lymphopoietin receptor (TSLPR). Chimeric antigen receptor (CAR) T cell therapy is a treatment that takes immune cells (T cells) from a person s body and modifies them to attack specific proteins. Researchers want to test whether TSLPR-CART cells can be given safely to adults with forms of B-cell leukemia, and to learn whether the treatment may help fight these cancers.\n\nObjective:\n\nTo test TSLPR-CART in people with B-ALL.\n\nEligibility:\n\nPeople aged 18 years and older with B-ALL that did not respond or returned after treatment. They must have TSLPR on their B-ALL.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. Samples will be taken from their bone marrow. They will have a lumbar puncture: A needle will be inserted into their back to collect a sample of the fluid around the spinal cord.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a tube. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different tube. The T cells will be used to create TSLPR-CART.\n\nParticipants will take chemotherapy over 5 days to prepare their body for the therapy; then they will receive the modified cells through a tube inserted into a vein. Staying in the hospital during part of the treatment is expected and participants will be monitored locally to evaluate for side effects. Approximately 1 month after receiving TSLPR-CART, participants will undergo evaluations to see how the TSLPR-CART impacted their leukemia. Participants will have follow-up visits for 2 years after TSLPR-CART either at NIH or at home....","conditions":["B-All","Acute Lymphoblastic Leukemia"],"keywords":["Adoptive Immunotherapy","CRLF2-R/TSLPR Expressing Tumor","Acute Lymphoblastic Leukemia","B-All"],"interventions":[{"type":"BIOLOGICAL","name":"TSLPR-CART"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Fludarabine"}],"enrollment":57,"startDate":"2026-11-15","completionDate":"2030-06-30","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\n  1. Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL).\n  2. TSLPR+ expression must be detected on \\>=80% of the malignant cells by NSR device. Note: TSLPR+ expression does not need to be repeated by NSR device if there is a documentation of TSLPR surface expression by flow cytometry from a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.\n  3. Participants must have a disease that is relapsed or refractory after initial systemic therapy and at least one salvage treatment, and must either be ineligible for, cannot access in a timely manner, or declined alternative curative options (including commercial CAR Tcell constructs\\*, and/or have relapsed after allogeneic HSCT).\n\n     \\*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs.\n  4. Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease\n  5. Age \\>= 18 years\n  6. Clinical performance status: Karnofsky \\>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.\n  7. Participants must have adequate organ and marrow function as defined below:\n\n     * Leukocytes \\>= 750/mcL\\*\n     * Platelets \\>= 50,000/mcL\\*\n     * Total bilirubin \\<= 2 x upper limit of normal (ULN) (except in the case of participants with documented Gilbert s disease \\> 3 X ULN)\n     * Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) \\<= 5 X institutional ULN\n     * Creatinine \\< 1.5X ULN OR Creatinine clearance \\>= 60 mL/min/1.73m\\^2 for participants with creatinine levels above max listed above\n\n       * A participant will not be excluded because of pancytopenia \\>=Grade 3 if it is due to underlying bone marrow involvement by leukemia\n  8. Cardiac function: left ventricular ejection fraction (LVEF) \\>=45% or fractional shortening \\>= 28%, and no clinically significant electrocardiogram (EKG) findings\n  9. Pulmonary Function: Baseline oxygen saturation \\> 92% on room air at rest without oxygen supplementation\n  10. Participants with the following central nervous system (CNS) status are eligible:\n\n      * CNS 1, defined as absence of blasts in CSF on cytospin preparation, regardless of the number of WBCs;\n      * CNS 2, defined as presence of \\< 5/mcL WBCs in CSF and cytospin positive for blasts, or \\> 5/mcL WBCs but negative by Steinherz/Bleyer algorithm:\n\n        * CNS 2a: \\< 10/mcL red blood cells (RBCs); \\< 5/mcL WBCs and cytospin positive for blasts;\n        * CNS 2b: \\>=10/mcL RBCs; \\< 5/mcL WBCs and cytospin positive for blasts;\n        * CNS 2c: \\>=10/mcL RBCs; \\>= 5/mcL WBCs and cytospin positive for blasts but negative by Steinherz/Bleyer algorithm.\n  11. Contraception:\n\n      * Women of child-bearing potential (WOCBP) must agree to use a highly effective contraception (hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at the study entry and up to 12 months after the last dose of combined chemotherapy. Note: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n      * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and for 4 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men able to father a child must not freeze or donate sperm within the same period.\n  12. Nursing participants must be willing to discontinue nursing from study treatment initiation through 1 month after the last dose of the study drug(s).\n  13. Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n  14. Participant or LAR must understand and sign a written informed consent.\n\n      EXCLUSION CRITERIA:\n\n  <!-- -->\n\n  1. Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease\n  2. CNS 3 disease including participants with radiologically detected active CNS lymphoma, or participants who have cranial nerve palsy from active CNS leukemia. Note: Chronic complications of prior CNS disease are not exclusionary in the absence of active disease (e.g., blindness from prior ocular CNS disease or persistent cranial nerve palsy)\n  3. Hyperleukocytosis (\\>=50,000 blasts/mcL)\n  4. Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening.\n  5. Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):\n\n     ====\n\n     Therapy: Systemic chemotherapy, antineoplastic investigational agents, or antibody-based therapies, any investigational therapy\n\n     Washout\\*: \\>= 2 weeks\n\n     Exceptions: 6 weeks for clofarabine or nitrosoureas No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance type chemotherapy (vincristine, 6- mercaptopurine, oral methotrexate, or a tyrosine kinase for participants with Ph+ or Ph-like ALL) provided there is recovery from any acute toxic effects.\n\n     ====\n\n     Therapy: Radiation therapy\n\n     Washout\\*: \\>= 3 weeks\n\n     Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable/evaluable disease outside the radiation window.\n\n     ====\n\n     Therapy: History of allogeneic HSCT\n\n     Washout\\*: \\>=100 days since HSCT; \\>=30 days since completion of immunosuppression; \\>=6 weeks since donor lymphocyte infusion (DLI)\n\n     ====\n\n     Therapy: History of prior CAR therapy or other adoptive cell therapies\n\n     Washout\\*: \\> 30 days post infusion\n     * Time between prior therapy and apheresis or prior to start of LD if apheresis is not done on this protocol.\n  6. Human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.\n  7. Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HbsAg).\n  8. Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.\n  9. Active second malignancy with the exception of in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n  10. History of severe, immediate hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n  11. Evidence of active graft-versus- host disease (GVHD).\n  12. Uncontrolled, symptomatic, intercurrent illness or social situations as evaluated by medical history, physical exam, and laboratory evaluations that would limit compliance with study requirements or would pose an unacceptable risk to the participant.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NCI Ped LeukemiaLymph Cell Tx Tm","phone":"(240) 760-6970","email":"ncilltct@mail.nih.gov"},{"name":"John W Glod, M.D.","phone":"(240) 760-6194","email":"john.glod@nih.gov"}],"primaryOutcomes":["To assess the safety of administering escalating doses of TSLPR-CART containing a tEGFR suicide switch to determine an MTD"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":["car-t"],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1: testing TSLPR-CART for B-All","inPlainEnglish":"Background: B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat.","whoItsFor":["Ages 18 Years to 120 Years","Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL)","\\*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs","Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease","Clinical performance status: Karnofsky \\>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score","Participants must have adequate organ and marrow function as defined below:","Leukocytes \\>= 750/mcL\\*","Platelets \\>= 50,000/mcL\\*"],"whoShouldSkip":["Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease","Hyperleukocytosis (\\>=50,000 blasts/mcL)","Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening","Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):","Therapy: Systemic chemotherapy, antineoplastic investigational agents, or antibody-based therapies, any investigational therapy","Washout\\*: \\>= 2 weeks","Therapy: Radiation therapy"],"whatHappens":"If you join, the listed intervention(s) are TSLPR-CART, Cyclophosphamide, or Fludarabine. The registry lists allocation as na. Background: B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 57 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.805Z"},{"nctId":"NCT07572812","title":"A Phase I Clinical Trial of UX-GIP001 in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy","officialTitle":"A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of UX-GIP001 (Human GABAergic Interneuron Progenitor Cells Injection) in the Treatment of Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Shanghai UniXell Biotechnology Co., Ltd","sponsorClass":"INDUSTRY","summary":"This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE). The primary objective is to assess the safety, tolerability, and preliminary efficacy of UX-GIP001. This is an open-label, single-arm study. All enrolled participants will receive the active investigational cell therapy. Seizure frequency and safety parameters will be evaluated by comparing post-transplant outcomes to pre-transplant baselines.","conditions":["Epilepsy"],"keywords":["Epilepsy","MTLE","Cell therapy"],"interventions":[{"type":"DRUG","name":"UX-GIP001"}],"enrollment":12,"startDate":"2026-09-05","completionDate":"2029-07-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-75 years (inclusive), male or female;\n* Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;\n* Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);\n* Meeting the diagnostic criteria for drug-resistant epilepsy;\n* Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;\n* On a stable dose of anti-seizure medications for ≥1 month prior to enrollment;\n* Patient has adequate organ function as follows: absolute neutrophil count ≥2.0×10⁹/L; white blood cell count ≥4.0×10⁹/L; platelet count ≥100×10⁹/L; AST and ALT ≤2.5× upper limit of normal (ULN); total bilirubin ≤1.5× ULN; serum creatinine ≤1.5× ULN; estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using the CKD-EPI formula);\n* Women of childbearing potential must have a negative serum pregnancy test during the screening period. All participants and their partners agree to have no plans for pregnancy, sperm donation, or egg donation from the time of signing the informed consent form until 2 years after cell transplantation treatment, and voluntarily adopt contraceptive measures deemed effective by the investigator;\n* Patient has good compliance, with a patient diary completion rate ≥80% prior to enrollment.\n\nExclusion Criteria:\n\n* Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations.\n* History of epilepsy surgery.\n* History of status epilepticus within 12 months prior to screening.\n* Presence of long-term implants in the skull or intracranial space.\n* Severe systemic disease or dysfunction.\n* Primary or secondary immunodeficiency.\n* History of clear suicidal intent, plan, or behavior within one year prior to screening.\n* Severe psychiatric disorders.\n* History of malignancy within the past 5 years, except for cervical carcinoma in situ, basal cell or squamous cell skin cancer cured for \\>5 years.\n* Pregnant or breastfeeding women.","locations":[{"facility":"Beijing Tiantan Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"West China School of Medicine and West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xianwei Zhi","phone":"+86-21-60197620","email":"xianweizhi@unixell.com"}],"primaryOutcomes":["Incidence and severity of Adverse Events (AEs)/Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["beijing-china","zhengzhou-china","chengdu-china"],"enrichment":{"headline":"Phase 1: testing UX-GIP001 for Epilepsy","inPlainEnglish":"This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE). The primary objective is to assess the safety, tolerability, and preliminary how well it works of UX-GIP001.","whoItsFor":["Ages 18 Years to 75 Years","Age 18-75 years (inclusive), male or female;","Diagnosis of focal epilepsy according to the International League Against Epilepsy (ILAE) 2025 epilepsy classification, with disease duration ≥2 years;","Clinical presentation consistent with unilateral mesial temporal lobe epilepsy (MTLE);","Meeting the diagnostic criteria for drug-resistant epilepsy;","Average focal seizure frequency ≥4 per 28 days within the 3 months prior to screening;","On a stable dose of anti-seizure medications for ≥1 month prior to enrollment;","Patient has good compliance, with a patient diary completion rate ≥80% prior to enrollment"],"whoShouldSkip":["Epilepsy caused by other/or progressive neurological diseases , or patients - experiencing only focal aware seizures without observable manifestations","History of epilepsy surgery","History of status epilepticus within 12 months prior to screening","Presence of long-term implants in the skull or intracranial space","Severe systemic disease or dysfunction","Primary or secondary immunodeficiency","History of clear suicidal intent, plan, or behavior within one year prior to screening"],"whatHappens":"If you join, the listed intervention(s) are UX-GIP001. The registry lists allocation as na. This is a phase I study (Protocol: UX-GIP001-102) investigating UX-GIP001 Injection, a novel cell therapy product consisting of human GABAergic interneuron progenitor cells (GIP), for treating adult patients with drug-resistant unilateral medial temporal lobe epilepsy (MTLE).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.903Z"},{"nctId":"NCT07574541","title":"Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","officialTitle":"Phase II Trial of a Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nProstate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring. However, 35% of men with this cancer will need treatment within 5 years because of tumor growth. Researchers want to know if a new vaccine that targets 3 anti-cancer proteins (TriAdeno) plus a drug (N-803) approved for bladder cancer can help stop prostate tumors from growing.\n\nObjective:\n\nTo test TriAdeno and N-803 in people with early-stage prostate cancer.\n\nEligibility:\n\nPeople aged 18 years and older with early-stage low- or medium-risk prostate cancer.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They will have an imaging scan. They may have a rectal exam.\n\nTriAdeno is injected under the skin of the upper thigh; N-803 is injected under the skin of the abdomen. Participants will be treated in up to four 21-day cycles. They will get both injections on the first day of each cycle.\n\nParticipants may opt to complete a memory aid: They may record all of their symptoms for 7 days after each injection. They may also complete a questionnaire about their prostate symptoms.\n\nBlood tests, imaging scans, and other tests will be repeated during the study.\n\nA tissue sample (biopsy) of the tumor will be collected during or after cycle 2; a second biopsy may be taken about 1 year later.\n\nParticipants will have follow-up phone calls for 5 years....","conditions":["Adenocarcinoma","Prostate Cancer","Neoplasms","Carcinoma","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type"],"keywords":["Immune Infiltration"],"interventions":[{"type":"BIOLOGICAL","name":"TriAdeno vaccine"},{"type":"DRUG","name":"N-803"}],"enrollment":52,"startDate":"2026-11-15","completionDate":"2028-06-15","sex":"MALE","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Histologically confirmed diagnosis of organ confined, low- or intermediate-risk PCa (Gleason grade group 1 or 2) identified in at least one prostate biopsy core. Biopsies performed at outside institutions should have Gleason score confirmed at the NCI by a genitourinary (GU) pathologist.\n* Participants must be on active surveillance.\n* Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H\\&E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation.\n* Serum PSA level of \\<20 ng/mL (or \\<10ng/mL for participants being treated with 5- alpha-reductase inhibitors)\n* Clinical stage \\<=T2a by digital rectal exam (DRE)\n* Age \\>=18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\<=1.\n* Adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\>=1.0 x 10\\^9/L\n  * Hemoglobin (Hgb) \\>=9 g/dL\n  * Platelets \\>=75,000/mcL\n  * Prothrombin International Normalized Ratio (INR) \\<1.5 x upper limit of normal (ULN)\n  * Partial thromboplastin time (PTT) \\<1.5 x ULN\n  * Total bilirubin \\<1.5 x ULN\n  * Aspartate aminotransferase (AST) \\<=2.5 x ULN\n  * Alanine aminotransferase (ALT) \\<=2.5 x ULN\n  * Creatinine \\<=1.5 x ULN\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL/min/1.73 m\\^2 for individuals with creatinine levels above institutional normal (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n* Treatment with steroid therapy must have a washout of at least 6 weeks prior to initiation of study treatment. Physiologic (replacement) doses of steroids as well as nasal, topical, or inhaled steroids are allowed.\n* Vaccination with a live (attenuated) vaccine (e.g., FluMist(R)) or a killed (inactivated)/subunit vaccine (e.g., PNEUMOVAX(R), Fluzone(R)) must occur not sooner than 28 days or 14 days, respectively, prior to initiation of study treatment.\n* Participants must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to one (1) month after the last study drug injection. Participants must not freeze or donate sperm within the same period.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy.\n* Evidence of PCa with metastatic disease.\n* Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines.\n* Prior solid organ or bone marrow transplant.\n* Immunodeficiency or splenectomy.\n* Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology.\n* History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled.\n* History of heart disease, such as congestive heart failure (class II, III, or IV defined by the New York Heart Association functional classification), history of unstable or poorly\n\ncontrolled angina, or history (\\<1 year prior to initiation of study therapy) of ventricular arrhythmia.\n\n* Acute or chronic skin disorders that will interfere with injection into the skin of the extremities or subsequent assessment of potential skin reactions.\n* Second malignancy within 3 years prior to initiation of study therapy. Note: Individuals with curatively treated non-melanoma skin cancers or non-muscle invasive bladder cancer will not be excluded.\n* History of herbal products that may decrease PSA levels (e.g., saw palmetto).\n* Participants who have undergone surgery within 4 weeks prior to initiation of study therapy.\n* Participants receiving any other investigational agents within 30 days prior to initiation of study therapy.\n* History of allergic reaction attributed to compounds of similar chemical or biological composition to the study drugs.\n* Uncontrolled intercurrent illness that would limit compliance with study requirements suggested by medical history, physical examination, or standard clinical assessments such as imaging, EKG, and laboratory studies.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Genevieve C Fromm","phone":"(240) 858-3663","email":"genevieve.fromm@nih.gov"},{"name":"Peter A Pinto, M.D.","phone":"(240) 858-3700","email":"pp173u@nih.gov"}],"primaryOutcomes":["To determine the effect of TriAdeno vaccine with N-803 on immune infiltration of the local tumor environment"],"hasResults":false,"conditionSlugs":["prostate-cancer","bladder-cancer","als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 2: testing TriAdeno vaccine for Adenocarcinoma","inPlainEnglish":"Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States. Early-stage, low-grade prostate cancer is managed with active monitoring.","whoItsFor":["Ages 18 Years to 120 Years","Men only","Participants must be on active surveillance","Pre-study treatment tissue availability (at least one formalin-fixed paraffin embedded \\[FFPE\\] biopsy core or one H\\&E-stained slide and at least 5 unstained slides) obtained between 3 and 24 months prior to treatment initiation is mandatory for study initiation","Serum PSA level of \\<20 ng/mL (or \\<10ng/mL for participants being treated with 5- alpha-reductase inhibitors)","Clinical stage \\<=T2a by digital rectal exam (DRE)","Eastern Cooperative Oncology Group (ECOG) performance status \\<=1","Adequate organ and marrow function as defined below:","Absolute neutrophil count (ANC) \\>=1.0 x 10\\^9/L"],"whoShouldSkip":["Prior treatment for PCa by surgery, radiation, local ablative (i.e., cryosurgery or highintensity focused ultrasound), or androgen-deprivation therapy","Evidence of PCa with metastatic disease","Prior treatment with adenovirus-based vector immunotherapy, adenovirus-based vaccines, or investigational vaccines","Prior solid organ or bone marrow transplant","Immunodeficiency or splenectomy","Presence of a known active acute or chronic infection, including human immunodeficiency virus (HIV), confirmed by PCR, and hepatitis B virus (HBV) and hepatitis C virus (HCV), as determined by hepatitis B surface antigen (HBsAg) and HCV serology","History of autoimmune disease (active or past), except for autoimmune-related thyroid disease, type I diabetes, and vitiligo if the condition(s) is well controlled"],"whatHappens":"If you join, the listed intervention(s) are TriAdeno vaccine, or N-803. The registry lists allocation as na. Background: Prostate cancer is the second most common cause of cancer-related death among men in the United States.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 52 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.305Z"},{"nctId":"NCT07574723","title":"Tirzepatide Titration to Reduce Side Effects in Individuals With Obesity","officialTitle":"Tirzepatide Titration to Reduce Side Effects (TiTRE) in Individuals With Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Dasman Diabetes Institute","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness. The main questions it aims to answer are:\n\n* Does flexible, symptom-guided titration increase time on treatment (delay treatment discontinuation) compared with standard per-label titration over 76 weeks?\n* Does flexible titration reduce gastrointestinal side effects, such as nausea and vomiting, compared with standard titration?\n* Does flexible titration achieve weight loss comparable to standard titration?\n\nResearchers will compare standard per-label titration with a click-based, symptom-guided titration approach to assess differences in treatment persistence, tolerability, and effectiveness.\n\nParticipants will:\n\n* Be randomly assigned to standard or flexible tirzepatide titration\n* Use a click-based dosing method that allows small dose increases based on tolerability (flexible group)\n* Attend study visits over 76 weeks for safety and outcome assessments\n\nThis study addresses the lack of evidence for individualized titration strategies in obesity treatment and aims to improve tolerability, treatment persistence, and long-term treatment outcomes.","conditions":["Obesity"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tirzepatide (Per-label titration)"},{"type":"DRUG","name":"Tirzepatide (Flexible titration)"}],"enrollment":68,"startDate":"2026-05-15","completionDate":"2029-05-15","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 18 years and older\n2. A diagnosis of obesity (BMI ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight.\n3. No diagnosis of diabetes mellites.\n4. Able to understand and sign the consent form\n5. Able to undergo DEXA scan.\n\nExclusion Criteria:\n\n* 1\\. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:\n\n  * A self-reported change in body weight \\>5 kg (11 lbs) within 90 days before screening irrespective of medical records.\n  * Treatment with any medication for the indication of obesity within the past 90 days before screening.\n  * Current use, or use within 90 days before screening, of medications with the potential to increase body weight (e.g., systemic glucocorticosteroids, antipsychotics, antidepressants, and antiepileptics) or to reduce body weight (e.g., diuretics).\n  * Previous or planned (during the trial period) obesity treatment with surgery or a weight-loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \\>1 year before screening; (2) lap banding, if the band has been removed \\>1 year before screening; (3) intragastric balloon, if the balloon has been removed \\>1 year before screening; or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \\>1 year before screening.\n  * Uncontrolled thyroid disease, defined as thyroid stimulating hormone \\>6.0 mIU/L or \\<0.4 mIU/L as measured by the central laboratory at screening.\n\n    3\\. Mental health:\n  * History of major depressive disorder within 2 years before screening.\n  * Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder).\n  * A Patient Health Questionnaire-9 score of ≥15 at screening.\n  * A lifetime history of a suicidal attempt.\n  * Suicidal behavior within 30 days before screening. 4. General safety:\n  * Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening.\n  * Presence of acute pancreatitis within the past 180 days prior to the day of screening.\n  * History or presence of chronic pancreatitis.\n  * Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.\n  * Renal impairment measured as estimated glomerular filtration rate value of \\<15 mL/min/1.73 m2 as defined by KDIGO 2012 by the central laboratory at screening.\n  * History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.\n  * Any of the following: myocardial infarction, stroke, hospitalization for unstable angina, or transient ischemic attack within the past 60 days prior to screening.\n  * Subject presently classified as being in New York Heart Association Class IV.\n  * Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator.\n  * Known or suspected abuse of alcohol or recreational drugs.\n  * Known or suspected hypersensitivity to trial product(s) or related products.\n  * Previous participation in this trial. Participation is defined as signed informed consent.\n  * Participation in another clinical trial within 90 days before screening.\n  * Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.\n  * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol.","locations":[{"facility":"Dasman Diabetes Institute","city":"Kuwait City","state":"","country":"Kuwait","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Time to discontinuation of the treatment regimen"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["kuwait-city-kuwait"],"enrichment":{"headline":"Not a traditional drug phase: testing Tirzepatide (Per-label titration) for Obesity","inPlainEnglish":"The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness. The main questions it aims to answer are: * Does flexible, symptom-guided titration increase time on treatment (delay treatment discontinuation) compared with standard per-label titration over 76 weeks?","whoItsFor":["Ages 18 Years to 100 Years","Adults aged 18 years and older","A diagnosis of obesity (body-mass index (BMI) ≥ 27 kg/m2) at screening with self-reported unsuccessful dietary efforts to lose weight","No diagnosis of diabetes mellites","Able to undergo DEXA scan"],"whoShouldSkip":["1\\. History of type 1 or type 2 diabetes mellites. 2. Obesity-related:","A self-reported change in body weight \\>5 kg (11 lbs) within 90 days before screening irrespective of medical records","Treatment with any medication for the indication of obesity within the past 90 days before screening","Current use, or use within 90 days before screening, of medications with the potential to increase body weight (e.g., systemic glucocorticosteroids, antipsychotics, antidepressants, and antiepileptics) or to reduce body weight (e.g., diuretics)","Uncontrolled thyroid disease, defined as thyroid stimulating hormone \\>6.0 mIU/L or \\<0.4 mIU/L as measured by the central laboratory at screening","History of major depressive disorder within 2 years before screening","Diagnosis of other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide (Per-label titration), or Tirzepatide (Flexible titration). The registry lists allocation as randomized. The goal of this clinical trial is to determine whether a flexible, symptom-guided titration strategy for tirzepatide can help adults with obesity without diabetes stay on treatment longer, while maintaining weight-loss effectiveness.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 68 people at Kuwait City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.025Z"},{"nctId":"NCT07574879","title":"Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:","officialTitle":"Impact of Eradication Therapy on Helicobacter Pylori Infection in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Study","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Zagazig University","sponsorClass":"OTHER_GOV","summary":"Helicobacter pylori (HP) is a well-established pathogen responsible for chronic gastritis and peptic ulcer disease. Its presence has been implicated in the development of gastric malignancies such as adenocarcinoma and mucosa-associated lymphoid tissue lymphoma. Chronic H. pylori infection is associated with systemic inflammatory responses and various extra gastric diseases, including cardiovascular, metabolic, and neurological disorders. Furthermore, H. pylori infection contributes to gastrointestinal dysbiosis by interacting with gastrointestinal microbiota, which may be involved in gastric carcinogenesis and other systemic disorders. Growing evidence highlights the role of dysbiosis in chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) and asthma. Emerging epidemiological evidence suggests a potential association between H. pylori infection and respiratory diseases, including COPD. Several observational studies and meta-analyses have found that H. pylori infection in patients with COPD may be associated with systemic inflammatory markers and altered pulmonary function parameters. Despite these associations, the causal mechanisms underlying this relationship remain unclear. Furthermore, it is uncertain whether eradication of H. pylori yields measurable benefits on clinical outcomes in COPD patients. So, Our aim to evaluate changes in symptoms, pulmonary function, and inflammatory markers after H. pylori eradication therapy in the H. pylori-positive COPD patients.\n\nan intervention study (quasi experimental), study will be carried out in the inpatient and outpatient clinics of Chest Department, Faculty of Medicine, Zagazig University hospitals.\n\nPatients included in the study:\n\nwell controlled COPD patients attending outpatient clinics for a period of 6 months fulfilling inclusion and exclusion criteria will be included in this study.","conditions":["Chronic Obstructive Pulmonary Disease (COPD)","With Poitive H Pylori"],"keywords":["Chronic Obstructive Pulmonary disease","Helicobacter Pylori","eradication therapy"],"interventions":[{"type":"DRUG","name":"Eradication of Helcobacter Pylori"}],"enrollment":54,"startDate":"2026-03-01","completionDate":"2026-09-30","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged ≥40 years.\n* Diagnosed with COPD confirmed by spirometry (post-bronchodilator FEV1/FVC \\< 0.70) and H. pylori positive.\n* Willing to participate and provide consent for testing and follow-up.\n\nExclusion Criteria:\n\n* patients with asthma, known peptic ulcers, acute exacerbation of COPD\n* patients who took antibiotics and PPIs within the last month,\n* Patients who took histamine-2-receptor antagonists within the last week or antacid within the last 24 hours a\n* those having H. pylori eradication treatment within the last 6 months","locations":[{"facility":"Zagazig University outpatients clinics","city":"Zagazig","state":"Elsharkia","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hanaa A Nofal, MD","phone":"01006806873","email":"hanofal@medicine.zu.edu.eg"},{"name":"Maha Elsayed Alsadik, MD","phone":"01127123248","email":""}],"primaryOutcomes":["Primary outcome measures"],"hasResults":false,"conditionSlugs":["lymphoma","als","asthma","copd"],"drugSlugs":[],"locationSlugs":["zagazig-egypt"],"enrichment":{"headline":"Phase 1: testing Eradication of Helcobacter Pylori for Chronic Obstructive Pulmonary Disease (COPD)","inPlainEnglish":"Helicobacter pylori (HP) is a well-established pathogen responsible for chronic gastritis and peptic ulcer disease. Its presence has been implicated in the development of gastric malignancies such as adenocarcinoma and mucosa-associated lymphoid tissue lymphoma.","whoItsFor":["Ages 40 Years to any","Adults aged ≥40 years","Diagnosed with COPD confirmed by spirometry (post-bronchodilator FEV1/FVC \\< 0.70) and H. pylori positive"],"whoShouldSkip":["patients with asthma, known peptic ulcers, acute exacerbation of COPD","patients who took antibiotics and PPIs within the last month,","Patients who took histamine-2-receptor antagonists within the last week or antacid within the last 24 hours a","those having H. pylori eradication treatment within the last 6 months"],"whatHappens":"If you join, the listed intervention(s) are Eradication of Helcobacter Pylori. The registry lists allocation as na. Helicobacter pylori (HP) is a well-established pathogen responsible for chronic gastritis and peptic ulcer disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 54 people at Zagazig. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.657Z"},{"nctId":"NCT07576790","title":"Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting (EMBO-PROTECT)","officialTitle":"Evaluation of Balloon Guide Catheter as Proximal Protection During Carotid Artery Stenting: A Randomized Study (EMBO-PROTECT)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Instituto de Investigación Marqués de Valdecilla","sponsorClass":"OTHER","summary":"Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomized study evaluates the safety and efficacy of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.","conditions":["Carotid Artery Stenosis (Symptomatic and Asymptomatic)"],"keywords":["Carotid stenosis","Carotid artery stenting","Balloon guide catheter","Proximal embolic protection","Cerebral microembolism","Diffusion-weighted MRI","Stroke prevention"],"interventions":[{"type":"DEVICE","name":"balloon guide catheter"},{"type":"OTHER","name":"No Proximal Protection Group"}],"enrollment":126,"startDate":"2026-07-01","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptomatic or asymptomatic carotid artery stenosis\n* Candidate for carotid artery stenting\n* Written informed consent provided\n\nExclusion Criteria:\n\n* Vascular anatomy unsuitable for balloon guide catheter placement\n* Severe renal failure\n* Previous disabling stroke or symptomatic intracranial hemorrhage\n* Evidence of carotid thrombus\n* Severe common carotid artery lesion\n* Chronic atrial fibrillation on oral anticoagulation\n* Acute coronary syndrome within 30 days\n* Contraindications to anticoagulant or antiplatelet therapy\n* Contraindications to MRI\n* Contrast media allergy\n* Lack of prior dual antiplatelet therapy","locations":[{"facility":"Hospital Universitario Marqués de Valdecilla","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"veronica vidal","phone":"942203389","email":"veronica.vidal@idival.org"},{"name":"lucia lavin","phone":"","email":"lucia.lavin@idival.org"}],"primaryOutcomes":["Incidence, number, and volume of new cerebral ischemic lesions detected by diffusion-weighted MRI within 48 hours after carotid artery stenting"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["santander-spain"],"enrichment":{"headline":"Not a traditional drug phase: balloon guide catheter for Carotid Artery Stenosis (Symptomatic and Asymptomatic)","inPlainEnglish":"Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization. This prospective randomly assigned study evaluates the safety and how well it works of proximal embolic protection using a balloon guide catheter during CAS by comparing the incidence of diffusion-weighted MRI-detected microembolisms and symptomatic thromboembolic events between protected and unprotected procedures.","whoItsFor":["Ages 18 Years to any","Symptomatic or asymptomatic carotid artery stenosis","Candidate for carotid artery stenting"],"whoShouldSkip":["Vascular anatomy unsuitable for balloon guide catheter placement","Severe renal failure","Previous disabling stroke or symptomatic intracranial hemorrhage","Evidence of carotid thrombus","Severe common carotid artery lesion","Chronic atrial fibrillation on oral anticoagulation","Acute coronary syndrome within 30 days"],"whatHappens":"If you join, the listed intervention(s) are balloon guide catheter, or No Proximal Protection Group. The registry lists allocation as randomized. Carotid angioplasty and stenting (CAS) is an effective treatment for carotid artery stenosis but carries a risk of cerebral embolization.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 126 people at Santander. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.206Z"},{"nctId":"NCT07577843","title":"A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","officialTitle":"A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \\[worsens with time\\] and life-threatening disease of the intestine).","conditions":["Crohn Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"JNJ-78934804"},{"type":"DRUG","name":"Guselkumab"}],"enrollment":460,"startDate":"2026-05-22","completionDate":"2028-06-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \\>= 220 but less than or equal to (\\<=) 450 and either: a. Mean daily stool frequency (SF) count \\>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \\>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)\n* Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria\n* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies\n\nExclusion criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC\n* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study\n* Presence of draining (that is, functioning) stoma or ostomy\n* Has a history of short bowel syndrome, is missing greater than (\\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to 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3: testing JNJ-78934804 for Colitis, Ulcerative","inPlainEnglish":"This study wants to assess how well JNJ-78934804 works (how well it works) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).","whoItsFor":["Ages 18 Years to any","Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC","Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy","An endoscopy subscore \\>=2 as obtained during central review of the screening video endoscopy","Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies"],"whoShouldSkip":["Isolated proctitis (UC limited to the rectum only or to less than \\[\\<\\] 20 centimeter \\[cm\\] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis","Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD","Has a history of or ongoing chronic or recurrent infectious disease","Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab","Is a participant who is pregnant, breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention"],"whatHappens":"If you join, the listed intervention(s) are JNJ-78934804, or Guselkumab. The registry lists allocation as randomized. This study wants to assess how well JNJ-78934804 works (how well it works) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 644 people at 318 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.212Z"},{"nctId":"NCT07578116","title":"Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis","officialTitle":"Randomized Phase III Trial of Multimodality Therapy Versus Standard of Care Systemic Therapy in HER2 Positive (HER2+) De Novo (AJCC Stage IV) Oligometastatic Breast Cancer With Response to Initial Chemotherapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"SWOG Cancer Research Network","sponsorClass":"NETWORK","summary":"This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread. There are a number of approved HER2-targeted systemic therapy regimens available to patients. These typically include immunotherapy and/or chemotherapy. Immunotherapy drugs may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Unlike systemic therapy, locoregional therapies like surgery and radiation are focused treatments at the site of disease, delivered with the intent of sparing healthy tissues. Breast surgeries such as breast conserving therapy or total mastectomy are procedures in which the cancerous breast tissue (and healthy breast tissue in the case of total mastectomy) are surgically removed from the body. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Adding locoregional therapy, as well as metastasis-directed SBRT, to standard systemic therapy may help patients with (oligo)metastatic, HER2-positive stage IV breast cancer live longer overall or before their cancer progresses, and may help more patients achieve no evidence of disease, when compared to standard systemic therapy alone.","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Metastatic HER2-Positive Breast Carcinoma","Oligometastatic Breast Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Breast Conservation Treatment"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Cyclin-Dependent Kinase 4 Inhibitor"},{"type":"DRUG","name":"Cyclin-Dependent Kinase 6 Inhibitor"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"HER2-targeted Therapy"},{"type":"DRUG","name":"Hormone Therapy"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"PROCEDURE","name":"Mammography"},{"type":"BIOLOGICAL","name":"Pertuzumab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"RADIATION","name":"Radiation Boost"},{"type":"RADIATION","name":"Radiation Therapy"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy"},{"type":"RADIATION","name":"Stereotactic Radiosurgery"},{"type":"DRUG","name":"Taxane Compound"},{"type":"PROCEDURE","name":"Total Mastectomy"},{"type":"BIOLOGICAL","name":"Trastuzumab"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"},{"type":"BIOLOGICAL","name":"Trastuzumab Emtansine"},{"type":"PROCEDURE","name":"Ultrasound Imaging"}],"enrollment":562,"startDate":"2027-03-09","completionDate":"2032-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* REGISTRATION STEP 1 - SCREENING \\& INITIAL TREATMENT:\n* Participants must have histologically confirmed de novo metastatic (i.e. American Joint Committee on Cancer \\[AJCC\\] stage IV, no prior history of breast cancer) HER2+ breast cancer with 1 to 5 distant metastatic lesions (oligometastatic). Metastatic breast cancer must be histologically confirmed through biopsy of a distant metastatic lesion unless it is not feasible or safe to biopsy a metastatic lesion, then there must be unequivocal evidence of metastasis on imaging and laboratory studies. HER2+ status must be confirmed in the breast tumor and distant metastatic site as defined per NCCN guidelines version 4.2025\n\n  * NOTE: If HER2 positivity at metastatic site is equivocal due to limitations in HER2 analysis in bone, or it is not feasible or safe to biopsy the metastatic lesion, then HER2 positivity based on breast tumor only is acceptable. If there is no breast lesion, HER2+ must be confirmed in at least one metastatic site\n* Participants with brain metastases are eligible if they meet all of the following criteria at baseline:\n\n  * There are 5 or fewer intracranial lesions\n  * Each intracranial lesions is no larger than 2cm in longest dimension\n  * NOTE: The brain is counted as 1 distant site towards the oligometastatic definition. Brain imaging is not required for participants who have no neurological signs or symptoms suggestive of central nervous system (CNS) involvement; however, assessment of neurological symptoms and brain MRI is strongly encouraged to rule out CNS disease\n* Participants must have no known leptomeningeal disease\n* Participants must meet one of the following criteria prior to Step 1 registration:\n\n  * Treatment naïve and planning to initiate standard of care systemic HER2+ targeted treatment OR\n  * Have already initiated standard of care systemic HER2+ targeted treatment and have completed at least one (≥ 1) but no more than three (≤ 3) cycles prior to enrollment, without progression\n\n    * NOTE: Standard of care scans for baseline disease assessment must have been performed within 28 days prior to initiation of treatment\n* Participants must not be receiving or planning to receive any investigational systemic therapy during study before disease progression\n* Participants must not have received whole brain irradiation\n\n  * NOTE: Participants with up to five brain metastases may have received SRS/SRT either before or after initiation of systemic therapy. If lesions are small and asymptomatic and the participant is receiving CNS penetration they may be managed with observation\n* Participants must be ≥ 18 years old at the time of registration\n* Participants must have Zubrod performance status of 0-2\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants must be able to safely receive the physician's choice of standard of care systemic HER2+ targeted treatment per the current Food and Drug Administration (FDA)-approved package insert(s), treating physician's discretion, and institutional guidelines\n* Participants must be candidates for definitive surgical and radiotherapeutic management of locoregional disease opinion per the discretion of the treating physician\n* Participants must be able to receive ablative dose stereotactic body radiation therapy (SBRT) to all metastatic lesions identified at baseline, in the opinion of the treating physician\n* Participants must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and CIRB regulations\n* REGISTRATION STEP 2 - COHORT ASSIGNMENT AND RANDOMIZATION:\n* COHORT A: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT A: Participants must have standard of care (SOC) staging scans and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT A: Participants must have experienced partial or complete response in the breast (in the opinion of the treating physician) following 12-24 weeks of initial systemic therapy based on staging scans performed within 14 days prior to Step 2 registration\n\n  * Participants with breast lesion(s) at diagnosis must have a clinical response on breast imaging per the treating physician\n  * Metastatic lesions, as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) and bone response criteria, must have at least stable disease\n  * Brain metastases treated with SRS/SRT must have at least stable disease as per Response Assessment in Neuro-Oncology Brain Metastases (RANO BM) and must not require steroid treatment\n  * Participants with no known breast lesions at diagnosis must have at least partial response in the metastatic sites as assessed by RECIST and bone response criteria\n  * NOTE: The same imaging modality must be used as in Step 1\n* COHORT A: Participants must be eligible for definitive surgical and radiotherapeutic management of locoregional disease per the discretion of the treating physician\n* COHORT A: Participants must not have metastatic lesions that are not amenable to ablative dose stereotactic body radiation therapy (SBRT)\n\n  * Lung lesions that completely resolve after systemic therapy will not be targeted with SBRT, as it is not possible to achieve dose build-up\n  * The development of new sclerotic bone lesions after systemic therapy is not to be interpreted as disease progression, and all such lesions should be targeted with SBRT\n* COHORT B: Participants must be registered to Step 2 within 14 days of staging scans performed after completing Step 1 systemic therapy\n* COHORT B: Participants must have standard of care (SOC) staging and breast imaging performed following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n* COHORT B: Participants must experience clinically stable disease or progression following 12-24 weeks (minimum of 4 cycles) of initial systemic therapy and within 14 days prior to Step 2 registration\n\n  * Participants must have progression in metastatic lesions as assessed by RECIST and bone response criteria or may have stable disease in metastatic lesions by RECIST and bone response criteria if there is progression or no clinical response in the breast\n  * Participants with known breast lesion must have progression or no clinical response on breast imaging as per the treating physician\n  * NOTE: The same modality must be used as in Step 1","locations":[{"facility":"NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Derby Care Center","city":"Derby","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center-Fairfield","city":"Fairfield","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center at Greenwich","city":"Greenwich","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Guilford","city":"Guilford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Hamden Care Center","city":"Hamden","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Center/Yale-New Haven Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale-New Haven Hospital North Haven Medical Center","city":"North Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center at Long Ridge","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Torrington Care Center","city":"Torrington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center-Trumbull","city":"Trumbull","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital-Waterbury Care Center","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Waterford","city":"Waterford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Joseph Medical Center","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Bloomington","city":"Bloomington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Canton","city":"Canton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Carthage","city":"Carthage","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Specialists of Illinois - Decatur","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Decatur Memorial Hospital","city":"Decatur","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Eureka","city":"Eureka","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Galesburg","city":"Galesburg","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Kewanee Clinic","city":"Kewanee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Macomb","city":"Macomb","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Care Center of O'Fallon","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HSHS Saint Elizabeth's Hospital","city":"O'Fallon","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Ottawa Clinic","city":"Ottawa","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Pekin","city":"Pekin","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peoria","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Francis Radiation Oncology at Peoria Cancer Center","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OSF Saint Francis Medical Center","city":"Peoria","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Peru","city":"Peru","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare-Princeton","city":"Princeton","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Illinois University School of Medicine","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Clinic","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Springfield Memorial Hospital","city":"Springfield","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois CancerCare - Washington","city":"Washington","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Cancer Center-West Lakes","city":"Clive","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Iowa Methodist Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Broadlawns Medical Center","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center - Des Moines","city":"Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Medical Center-West Lakes","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ascension Via Christi Hospitals Wichita","city":"Wichita","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Hospital and Cancer Center-Golden Triangle","city":"Columbus","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Cancer Center-Grenada","city":"Grenada","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Hospital and Cancer Center-Union County","city":"New Albany","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Hospital and Cancer Center-Oxford","city":"Oxford","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Francis Medical Center","city":"Cape Girardeau","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asplundh Cancer Pavilion","city":"Willow Grove","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Smilow Cancer Hospital Care Center - Westerly","city":"Westerly","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lexington Health","city":"West Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Hospital and Cancer Center-Collierville","city":"Collierville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baptist Memorial Hospital and Cancer Center-Memphis","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Memorial Regional Medical Center","city":"Mechanicsville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Saint Francis Medical Center","city":"Midlothian","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Saint Mary's Hospital","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bon Secours Cancer Institute at Reynolds Crossing","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Overall survival (OS) (Cohort A)","Progression-free survival (PFS) (Observational Cohort B)","Overall survival (Observational Cohort B)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["jonesboro-arkansas","derby-connecticut","fairfield-connecticut","greenwich-connecticut","guilford-connecticut","hamden-connecticut","new-haven-connecticut","north-haven-connecticut","stamford-connecticut","torrington-connecticut","trumbull-connecticut","waterbury-connecticut","waterford-connecticut","orlando-florida","bloomington-illinois","canton-illinois","carthage-illinois","decatur-illinois","eureka-illinois","galesburg-illinois","kewanee-illinois","macomb-illinois","ofallon-illinois","ottawa-illinois","pekin-illinois","peoria-illinois","peru-illinois","princeton-illinois","springfield-illinois","washington-illinois","clive-iowa","des-moines-iowa","west-des-moines-iowa","wichita-kansas","columbus-mississippi","grenada-mississippi","new-albany-mississippi","oxford-mississippi","cape-girardeau-missouri","philadelphia-pennsylvania","willow-grove-pennsylvania","westerly-rhode-island","west-columbia-south-carolina","collierville-tennessee","memphis-tennessee","mechanicsville-virginia","midlothian-virginia","richmond-virginia"],"enrichment":{"headline":"Phase 3: testing Cyclin-Dependent Kinase 4 Inhibitor for Anatomic Stage IV Breast Cancer AJCC v8","inPlainEnglish":"This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic). The usual approach for patients with (oligo)metastatic HER2-positive breast cancer is systemic drug treatment, which means medicines that travel through the whole body to treat both the breast and any areas where the cancer has spread.","whoItsFor":["Ages 18 Years to any","REGISTRATION STEP 1 - SCREENING \\& INITIAL TREATMENT:","Participants with brain metastases are eligible if they meet all of the following criteria at baseline:","There are 5 or fewer intracranial lesions","Each intracranial lesions is no larger than 2cm in longest dimension","Participants must have no known leptomeningeal disease","Participants must meet one of the following criteria prior to Step 1 registration:","Treatment naïve and planning to initiate standard of care systemic HER2+ targeted treatment OR"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Breast Conservation Treatment. The registry lists allocation as randomized. This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted systemic therapy, compared to standard systemic therapy alone, in treating patients with HER2-positive stage IV breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or to a limited number of sites (oligometastatic).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 562 people at 59 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.363Z"},{"nctId":"NCT07580638","title":"Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes","officialTitle":"Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Chipscreen Biosciences, Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are:\n\nWhat is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control? What are the effects of this combination therapy on cardiovascular, renal, and hepatic outcomes? What is the overall safety of this treatment regimen?\n\nThis is a non-interventional study. Participants will be prescribed Chiglitazar or other oral antidiabetic drugs by their treating physician as part of their routine clinical care. For the purpose of this registry study, data will be collected from their regular medical follow-ups. Participants will:\n\nAttend regular follow-up visits as part of their standard diabetes care. Have data collected from their routine clinical assessments.","conditions":["T2DM (Type 2 Diabetes Mellitus)"],"keywords":[],"interventions":[{"type":"DRUG","name":"SGLT-2 inhibitor and Chiglitazar"},{"type":"DRUG","name":"SGLT-2 inhibitor and Other Oral Antidiabetic Drugs (OADs)"}],"enrollment":3550,"startDate":"2026-09-04","completionDate":"2028-01-18","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive.\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM) .\n* Receiving stable-dose SGLT-2 inhibitor monotherapy or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%.\n* Must be willing to participate and have provided written informed consent.\n\nExclusion Criteria:\n\n* Current or routine use of insulin therapy.\n* Use of three or more antidiabetic drugs within one month prior to screening.\n* Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA).\n* Prior treatment with Chiglitazar Sodium.\n* Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C).\n* Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m².","locations":[{"facility":"Beijing Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital of Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wang","phone":"+86 0755-36993550","email":"xinhwang@chipscreen.com"}],"primaryOutcomes":["Glycated Hemoglobin (HbA1c)"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["beijing-china","chengdu-china"],"enrichment":{"headline":"Not a traditional drug phase: testing SGLT-2 inhibitor and Chiglitazar for T2DM (Type 2 Diabetes Mellitus)","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to measure the comprehensive clinical how well it works, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are: What is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control?","whoItsFor":["Ages 18 Years to 75 Years","Age between 18 and 75 years, inclusive","Diagnosis of Type 2 Diabetes Mellitus (T2DM)","Receiving stable-dose SGLT-2 inhibitor this drug alone or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%"],"whoShouldSkip":["Current or routine use of insulin therapy","Use of three or more antidiabetic drugs within one month prior to screening","Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA)","Prior treatment with Chiglitazar Sodium","Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C)","Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \\< 30 mL/min/1.73 m²"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,550 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.527Z"},{"nctId":"NCT07581405","title":"GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","officialTitle":"GI-05: The Impact of Olanzapine Among Patients Receiving Neoadjuvant Chemotherapy for Gastric Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Illinois Chicago","sponsorClass":"OTHER","summary":"This is a single-center, randomized, open-label clinical trial designed to evaluate the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomized to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection. Patients will otherwise receive standard-of-care (SOC) oncologic treatment, with no alterations to chemotherapy regimens or surgical management. The study is designed to prospectively assess whether olanzapine improves appetite, mitigates weight loss, and enhances nutritional status and quality of life (QoL) during neoadjuvant therapy. This study will be conducted at the University of Illinois Cancer Center (UICC) as a single-site investigator-initiated trial, with an anticipated accrual of 26 participants over 2 years.","conditions":["Gastric Adenocarcinoma","Gastric Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Neoadjuvant chemotherapy"},{"type":"DRUG","name":"Olanzapine"}],"enrollment":26,"startDate":"2026-11-03","completionDate":"2028-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years of age at time of consent\n* Eastern Cooperative Oncology Group (ECOG) score of 0-2\n* Histologically confirmed gastric adenocarcinoma, documented by biopsy.\n* Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist.\n* Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.\n* Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.\n* Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n* As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy\n* Uncontrolled HIV/AIDS or active viral hepatitis\n* Pregnant or nursing\n* Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n* Patients with a feeding tube (e.g., gastrostomy or jejunostomy) who receive their primary source of nutritional intake via enteral tube feeding at the time of enrollment are excluded because the primary endpoints of appetite and weight change may not accurately reflect oral intake or appetite response in this population.\n* Other major comorbidity, as determined by the study PI\n* Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists.\n* Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe.\n* Patients with uncontrolled hyperglycemia that, in the opinion of the treating investigator, would make olanzapine administration unsafe.","locations":[{"facility":"University of Illinois Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aslam Ejaz, MD","phone":"312-996-6666","email":"aejaz@uic.edu"},{"name":"Meredith Russell","phone":"312-355-5112","email":"mrussel3@uic.edu"}],"primaryOutcomes":["To evaluate weight change","To evaluate appetite"],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Phase 2: testing Neoadjuvant chemotherapy for Gastric Adenocarcinoma","inPlainEnglish":"This is a single-center, randomly assigned, open-label clinical trial designed to measure the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy. Eligible patients will be randomly assigned to receive olanzapine 2.5 mg orally once daily (QD) in addition to standard neoadjuvant chemotherapy, beginning prior to initiation of chemotherapy and continuing until surgical resection.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years of age at time of consent","Eastern Cooperative Oncology Group (ECOG) score of 0-2","Histologically confirmed gastric adenocarcinoma, documented by biopsy","Planned to receive neoadjuvant chemotherapy followed by surgical resection, as determined by the treating oncologist","Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration","Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines","As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study"],"whoShouldSkip":["Active infection requiring systemic therapy","Uncontrolled HIV/AIDS or active viral hepatitis","Pregnant or nursing","Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of this investigational regimen, as determined by the treating medical oncologist","Other major comorbidity, as determined by the study PI","Patients currently taking medications that may interact with olanzapine, including, but not limited to, other anti-psychotics, CNS depressants, or dopamine agonists","Patients with a clinically significant cardiac history or clinically significant QTc prolongation that, in the opinion of the treating investigator, would make olanzapine administration unsafe"],"whatHappens":"If you join, the listed intervention(s) are Neoadjuvant chemotherapy, or Olanzapine. The registry lists allocation as randomized. This is a single-center, randomly assigned, open-label clinical trial designed to measure the impact of low-dose olanzapine on weight loss, appetite, and nutritional outcomes in patients with gastric cancer receiving neoadjuvant chemotherapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 26 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.967Z"},{"nctId":"NCT07581470","title":"Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty","officialTitle":"Trial Evaluating Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"his study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best. Patients will be randomly assigned to receive either no dexamethasone, 4 mg, or 8 mg, in addition to standard anesthesia and a nerve block (PENG block). The main goal is to see how long patients go without needing additional pain medication after surgery. The study will also look at pain levels, use of opioid painkillers, nausea and vomiting, blood sugar levels, and possible side effects.","conditions":["Osteoarthritis, Hip","Hip Osteoarthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dexamethasone 4mg"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Dexamethasone 8mg"}],"enrollment":198,"startDate":"2026-05-08","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Scheduled for elective total hip arthroplasty (THA)\n* Planned use of regional anesthesia including PENG block\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand the study procedures and provide written informed consent\n* Ability to assess pain using the Numeric Rating Scale (NRS)\n\nExclusion Criteria:\n\n* Known hypersensitivity to dexamethasone or any component of the study medication\n* Chronic corticosteroid therapy or use of systemic steroids within 14 days prior to surgery\n* Active systemic infection or sepsis\n* Significant immunosuppression (e.g., chemotherapy, biological therapy)\n* Pregnancy or breastfeeding\n* Severe cognitive impairment or inability to reliably assess pain\n* Uncontrolled diabetes mellitus (e.g., HbA1c \\> 8.5% or baseline blood glucose \\> 200 mg/dL)","locations":[{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Małgorzata Reysner, MD PhD","phone":"+48 (61) 8310122","email":"mreysner@ump.edu.pl"},{"name":"Tomasz Reysner, MD PhD","phone":"+48 (61) 8310122","email":"mreysner@ump.edu.pl"}],"primaryOutcomes":["Time to First Rescue Analgesia"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: testing Dexamethasone 4mg for Osteoarthritis, Hip","inPlainEnglish":"His study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery. Dexamethasone is commonly used to reduce nausea and may also help with pain, but it is not clear which dose works best.","whoItsFor":["Ages 18 Years to 100 Years","Scheduled for elective total hip arthroplasty (THA)","Planned use of regional anesthesia including PENG block","American Society of Anesthesiologists (ASA) physical status I-III","Ability to assess pain using the Numeric Rating Scale (NRS)"],"whoShouldSkip":["Known hypersensitivity to dexamethasone or any component of the study medication","Chronic corticosteroid therapy or use of systemic steroids within 14 days prior to surgery","Active systemic infection or sepsis","Significant immunosuppression (e.g., chemotherapy, biological therapy)","Pregnancy or breastfeeding","Severe cognitive impairment or inability to reliably assess pain","Uncontrolled diabetes mellitus (e.g., HbA1c \\> 8.5% or baseline blood glucose \\> 200 mg/dL)"],"whatHappens":"If you join, the listed intervention(s) are Dexamethasone 4mg, Placebo, or Dexamethasone 8mg. The registry lists allocation as randomized. His study will test whether giving dexamethasone through a vein can improve pain control after total hip replacement surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 198 people at Poznan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.512Z"},{"nctId":"NCT07581795","title":"Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer","officialTitle":"A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study of Paclitaxel Polymeric Micelles Combined With Trastuzumab and Pertuzumab (HP) and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fudan University","sponsorClass":"OTHER","summary":"This study is a randomized, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the efficacy and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment.\n\nEligible subjects with histologically or cytologically confirmed advanced HER2-positive breast cancer were enrolled after obtaining informed consent. They were randomly assigned to two groups: the experimental group received paclitaxel polymer micelles for injection combined with trastuzumab, pertuzumab, and adrelumab; the control group received taxanes (paclitaxel, docetaxel, albumin-bound paclitaxel, paclitaxel polymer micelles) combined with trastuzumab and pertuzumab. Each treatment cycle lasted 3 weeks (Q3W), with administration on day 1 (D1) of each cycle. Therapy continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of alternative antitumor therapy, death, or any other treatment discontinuation criteria specified in the protocol-whichever occurred first.","conditions":["Advanced HER2-positive Breast Cancer"],"keywords":["Advanced breast cancer，HER2-positive，Paclitaxel Polymeric Micelles，Adebelimab"],"interventions":[{"type":"DRUG","name":"Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab"},{"type":"DRUG","name":"Taxanes combined with trastuzumab and pertuzumab."}],"enrollment":140,"startDate":"2026-07-28","completionDate":"2029-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"1. Age: ≥18 years, no gender restriction;\n2. Pathologically confirmed breast cancer: a) Advanced or metastatic breast cancer; b) Locally assessed as HER2-positive (IHC 3+ or IHC 2+ with ISH+);\n3. For advanced or metastatic breast cancer, patients should have not previously received chemotherapy or HER2-targeted therapy, or have received only first-line endocrine therapy. Subjects receiving chemotherapy or HER2-targeted therapy as neoadjuvant or adjuvant treatment are eligible if the interval from treatment completion to metastasis diagnosis exceeds 6 months;\n4. PD-L1 testing is positive (combined positive score CPS ≥ 1);\n5. ECOG score is 0-1;\n6. Estimated survival is at least 3 months;\n7. There is at least one measurable lesion assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) (according to RECIST 1.1);\n8. Basic normal function of major organs such as the heart, lungs, liver, and kidneys;\n9. Sufficient organ and bone marrow function, meeting the following criteria: (1) Complete blood count must meet: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; c) Platelet count (PLT) ≥ 75×10⁹/L; (2) Biochemical tests must meet: a) Serum total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); b) ALT and AST ≤ 2.5× ULN; if liver metastases are present, ALT and AST ≤ 5× ULN; c) Cr ≤ 1.5× ULN or creatinine clearance (CCr) ≥ 60 mL/min (Cockcroft-Gault formula);\n10. Patients voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.\n\nExclusion Criteria:\n\nSubjects were ineligible for this trial if they met any of the following criteria:\n\n1. Known allergy or intolerance to any study agent or excipient;\n2. Primary central nervous system malignancy or meningeal metastasis; symptomatic patients with central nervous system metastases; patients with asymptomatic brain metastases or clinically stable conditions requiring no steroid therapy for at least 4 weeks were eligible;\n3. History of chemotherapy, targeted therapy, or major surgery within 4 weeks prior to first dose; history of endocrine therapy or local radiotherapy within 2 weeks prior to first dose;\n4. Active or previously documented interstitial lung disease (ILD), pneumonia, or suspected ILD that could not be excluded by imaging during screening; pneumonia that could not be excluded by imaging during screening;\n5. History of other malignancies within 5 years that could be locally treated and cured (excluding basal cell carcinoma of the skin, superficial or non-invasive bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma, etc.);\n6. History of live vaccine vaccination within 28 days prior to treatment;\n7. Active autoimmune diseases (including but not limited to myasthenia gravis, myositis, asthma, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vitiligo, psoriasis, etc.); stable-dose hormone replacement therapy for hypothyroidism was excluded;\n8. Patients with significant coagulation disorders or other clear evidence of bleeding risk.\n9. Patients with the following cardiac conditions within 6 months prior to treatment initiation: acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events; cardiac dysfunction classified ≥ Class II on the New York Heart Association (NYHA) scale or left ventricular ejection fraction (LVEF) \\<50%; myocardial infarction, severe/unstable angina, cerebrovascular accident/stroke, transient ischemic attack, subarachnoid hemorrhage, or severe cardiac rhythm/conductance abnormalities requiring clinical intervention (e.g., ventricular arrhythmias, second-to-third-degree atrioventricular block, congenital long QT syndrome);\n10. Patients with active hepatitis B or C virus infection, HIV infection, or active pulmonary tuberculosis;\n11. Patients with active infections requiring antimicrobial therapy (e.g., antibiotics, antiviral agents, or antifungal drugs);\n12. Patients with a known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;\n13. Patients with a history of substance abuse (e.g., psychiatric medications) that cannot be discontinued or those with mental disorders;\n14. Pregnant or breastfeeding women; or patients of reproductive age who are unwilling or unable to use effective contraceptive measures.","locations":[{"facility":"Fudan University Shanghai Cancer center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jian Zhang","phone":"+8618017312991","email":"syner2000@163.com"}],"primaryOutcomes":["Objective response rate （ORR）"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["adalimumab"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab for Advanced HER2-positive Breast Cancer","inPlainEnglish":"This study is a randomly assigned, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the how well it works and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment. Eligible subjects with histologically or cytologically confirmed advanced HER2-positive breast cancer were enrolled after obtaining informed consent.","whoItsFor":["Ages 18 Years to any","Age: ≥18 years, no gender restriction;","Pathologically confirmed breast cancer: a) Advanced or metastatic breast cancer; b) Locally assessed as HER2-positive (IHC 3+ or IHC 2+ with ISH+);","PD-L1 testing is positive (combined positive score CPS ≥ 1);","Estimated survival is at least 3 months;","There is at least one measurable lesion assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) (according to RECIST 1.1);","Basic normal function of major organs such as the heart, lungs, liver, and kidneys;"],"whoShouldSkip":["Subjects were ineligible for this trial if they met any of the following criteria:","Known allergy or intolerance to any study agent or excipient;","Primary central nervous system malignancy or meningeal metastasis; symptomatic patients with central nervous system metastases; patients with asymptomatic brain metastases or clinically stable conditions requiring no steroid therapy for at least 4 weeks were eligible;","History of chemotherapy, targeted therapy, or major surgery within 4 weeks prior to first dose; history of endocrine therapy or local radiotherapy within 2 weeks prior to first dose;","Active or previously documented interstitial lung disease (ILD), pneumonia, or suspected ILD that could not be excluded by imaging during screening; pneumonia that could not be excluded by imaging during screening;","History of other malignancies within 5 years that could be locally treated and cured (excluding basal cell carcinoma of the skin, superficial or non-invasive bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma, etc.);","History of live vaccine vaccination within 28 days prior to treatment;"],"whatHappens":"If you join, the listed intervention(s) are Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab, or Taxanes combined with trastuzumab and pertuzumab.. The registry lists allocation as randomized. This study is a randomly assigned, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the how well it works and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 140 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.263Z"},{"nctId":"NCT07581951","title":"A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of HSK31679 in Patients With Metabolic Dysfunction Associated Steatohepatitis (MASH)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Haisco Pharmaceutical Group Co., Ltd.","sponsorClass":"INDUSTRY","summary":"A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .","conditions":["MASH - Metabolic Dysfunction-Associated Steatohepatitis","NASH (Non-Alcoholic Steatohepatitis)"],"keywords":[],"interventions":[{"type":"DRUG","name":"HSK31679"},{"type":"DRUG","name":"Placebo"}],"enrollment":886,"startDate":"2026-06-30","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* 1\\. Must be willing to participate in the study and provide written informed consent.\n* 2.Male and female adults ≥ 18 years of age.\n* 3.Have at least one cardiometabolic risk factors at screening.\n* 4.MRI-PDFF fat fraction ≥8%.\n* 5.Have a liver biopsy performed within 6 months prior to randomization, with histologically confirmed MASH assessed by the central laboratory; NAS score ≥ 4 points with at least 1 point each for inflammation and hepatocellular ballooning; meanwhile, CRN fibrosis stage is F2 ≤ fibrosis \\< F4. If no liver biopsy data are available within 6 months prior to randomization, a liver biopsy must be completed during the screening period.\n* 6.Body weight fluctuation \\< 5% for at least 6 weeks before randomization.\n\nKey Exclusion Criteria:\n\n* 1\\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening.\n* 2.MELD score ≥12 due to hepatic disease。\n* 3.Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy).\n* 4.Participants who had not been on stable medication with vitamin E (dose\\>400 IU/day) or polyunsaturated fatty acids or ursodeoxycholic acid within 6 months prior to liver biopsy (including historical biopsy); or had not been on stable medication with thiazolidinediones (TZD), sodium-glucose cotransporter 2 (SGLT2) inhibitors, or complex oral antidiabetic (OAD) regimens (≥3 OADs) within 3 months prior to liver biopsy (including historical biopsy).\n* 5.Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study.\n* 6.HbA1c ≥ 8.0%.\n* 7.Chronic liver diseases other than NASH.\n* 8.Active autoimmune disease. 9.Serum ALT \\> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \\< 2 years.","locations":[{"facility":"Beijing Tsinghua Changgung Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"fangqiong li","phone":"028-67258840","email":"lifangq@haisco.com"}],"primaryOutcomes":["Number of Participants With Resolution of Steatohepatitis Without Worsening of Fibrosis at Week 52.","Number of Participants With at Least an Improvement of Fibrosis ≥1 Stage Without Worsening of Steatohepatitis at Week 52.","Time to First Occurrence of Disease Progression"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 3: testing HSK31679 for MASH - Metabolic Dysfunction-Associated Steatohepatitis","inPlainEnglish":"A phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the whether it is safe and how hard side effects are to live with of HSK31679 compared to dummy treatment (placebo) in patients with metabolic dysfunction-associated steatohepatitis (MASH) .","whoItsFor":["Ages 18 Years to any","Male and female adults ≥ 18 years of age","Have at least one cardiometabolic risk factors at screening","MRI-PDFF fat fraction ≥8%","Body weight fluctuation \\< 5% for at least 6 weeks before randomization"],"whoShouldSkip":["1\\. History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Screening","MELD score ≥12 due to hepatic disease。","Received medication therapy that may induce MAFLD/MASH for ≥ 2 weeks within 12 months prior to liver biopsy (including historical biopsy)","Participants who have undergone bariatric surgery (e.g., gastroplasty, Roux-en-Y gastric bypass, etc.) within 5 years prior to screening or plan to receive such surgery during the study","Chronic liver diseases other than NASH","Active autoimmune disease. 9.Serum ALT \\> 250 U/L. 10.Active, serious medical disease with a likely life expectancy \\< 2 years"],"whatHappens":"If you join, the listed intervention(s) are HSK31679, or Placebo. The registry lists allocation as randomized. A phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating the whether it is safe and how hard side effects are to live with of HSK31679 compared to dummy treatment (placebo) in patients with metabolic dysfunction-associated steatohepatitis (MASH) .","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 886 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.166Z"},{"nctId":"NCT07582783","title":"A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in Romania","officialTitle":"Persistence to Treatment With Guselkumab in Bio-Naive Patients With Moderate-to-Severe Plaque Psoriasis: A Romanian Non-Interventional Multi-center Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.","conditions":["Psoriasis"],"keywords":[],"interventions":[],"enrollment":200,"startDate":"2026-05-15","completionDate":"2028-09-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Has a confirmed diagnosis of moderate-to-severe plaque psoriasis\n* Participant must sign an informed consent form allowing source data verification in accordance with local requirements\n* Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments\n* No previous exposure to biological treatment, including guselkumab (bio-naive patient)\n* Intended for the treatment with guselkumab according to the approved indication\n\nExclusion criteria:\n\n* Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)\n* Is pregnant or lactating\n* Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any interventional study with investigational product.\n* Currently enrolled in another observational study sponsored or managed by a Johnson \\& Johnson company","locations":[{"facility":"Mihaila G. Georgiana - Cabinet Medical Individual Dermatovenerologie","city":"Bârlad","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qualimed SRL","city":"Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Universitar de Urgenta Elias, Clinica de Cardiologie","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Colentina 1","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Colentina","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alin Nicolescu Medic Primar Dermato Venerologie","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"OptiDerm Estet","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean de Urgenta Cluj Napoca","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ambulator Specialitate Sp Militar de Urgenta Dr Constantin Papilian Cluj Napoca","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Derm SRL","city":"Constanța","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"MC Medica SRL","city":"Craiova","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinica Dr.Corbeanu","city":"Craiova","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinica Top Med Buna Vestire","city":"Craiova","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Derma Lux SRL","city":"Iași","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean de Urgenta Bihor","city":"Oradea","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Derma Lux SRL 1","city":"Reghin","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evaderm Health SRL","city":"Slatina","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Judetean de Urgenta 'Sf.Ioan cel Nou', Sectia Oncologie","city":"Suceava","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Cabimed","city":"Târgu-Mures","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr Tirziu Dermato Chirurgie SRL","city":"Timișoara","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Time to Guselkumab Discontinuation Throughout 2 Years"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["b-rlad-romania","brasov-romania","bucharest-romania","cluj-napoca-romania","constan-a-romania","craiova-romania","ia-i-romania","oradea-romania","reghin-romania","slatina-romania","suceava-romania","t-rgu-mures-romania","timi-oara-romania"],"enrichment":{"headline":"A Study of Persistence to Guselkumab Treatment in Participants With Moderate-to-Severe Plaque Psoriasis in …","inPlainEnglish":"This study aims to assess the proportion of participants with moderate-to-severe plaque psoriasis who continue treatment with guselkumab over a two-year period.","whoItsFor":["Ages 18 Years to any","Has a confirmed diagnosis of moderate-to-severe plaque psoriasis","Is able to read, understand, and complete the patient reported outcomes (PRO) instruments in local language and comply with completion of all PRO instruments","No previous exposure to biological treatment, including guselkumab (bio-who have not tried this kind of treatment before patient)","Intended for the treatment with guselkumab according to the approved indication"],"whoShouldSkip":["Meets any of the contraindications according to the latest version of the locally approved summary of product characteristics (SmPC)","Is pregnant or lactating","Current or recent (in the last 30 days prior to first SC dose of guselkumab) participation in any treatment study with investigational product","Currently enrolled in another watch-and-measure (no experimental treatment required) study sponsored or managed by a Johnson \\& Johnson company"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 20 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.578Z"},{"nctId":"NCT07584200","title":"Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty","officialTitle":"Comparison of the Efficacy and Safety of Three Regional Anesthesia Strategies in Patients Undergoing Elective Total Hip Arthroplasty: A Prospective, Randomized, Multicenter Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.\n\nThe main questions this study aims to answer are:\n\nWhich anesthesia method provides better pain control after surgery? Which method reduces the need for opioid pain medicines? Are there differences in side effects and recovery between the approaches? Participants will be randomly assigned to one of three groups. All participants will receive spinal anesthesia. One group will receive spinal anesthesia with intrathecal morphine. The other two groups will receive spinal anesthesia combined with a nerve block called the pericapsular nerve group (PENG) block, with or without the addition of dexamethasone.\n\nParticipants will have their pain levels measured at regular times during the first two days after surgery. Researchers will also record opioid use, time to first pain medication, ability to move after surgery, length of hospital stay, and any side effects such as nausea or itching. Blood tests will be used to measure markers of inflammation.\n\nThe results of this study may help doctors choose safer and more effective pain control strategies for people undergoing hip replacement surgery.","conditions":["Arthropathy of Hip","Hip Osteoarthritis"],"keywords":["total hip arthroplasty"],"interventions":[{"type":"DRUG","name":"Intrathecal Morphine"},{"type":"PROCEDURE","name":"Pericapsular Nerve Group Block"},{"type":"DRUG","name":"Dexamethasone"}],"enrollment":90,"startDate":"2026-05-07","completionDate":"2027-03-31","sex":"ALL","minAge":"60 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 60 to 100 years\n* Scheduled for elective total hip arthroplasty\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand the study procedures and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone\n* Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks\n* Infection at the site of spinal or peripheral nerve block injection\n* Pre-existing neurological disorders affecting sensory or motor function\n* Severe hepatic or renal insufficiency\n* Chronic opioid use for more than 3 months prior to surgery\n* Refusal or inability to provide informed consent","locations":[{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Malgorzata Reysenr, MD PhD","phone":"608762068","email":"mreysner@ump.edu.pl"},{"name":"Malgorzata Reysner, MD PhD","phone":"608762068","email":"mreysner@ump.edu.pl"}],"primaryOutcomes":["Total Postoperative Opioid Consumption"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: testing Intrathecal Morphine for Arthropathy of Hip","inPlainEnglish":"The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery. Researchers will study people aged 60 years and older who are scheduled for elective total hip arthroplasty.","whoItsFor":["Ages 60 Years to 100 Years","Adults aged 60 to 100 years","Scheduled for elective total hip arthroplasty","American Society of Anesthesiologists (ASA) physical status I-III"],"whoShouldSkip":["Known allergy or hypersensitivity to ropivacaine, morphine, or dexamethasone","Coagulation disorders or ongoing anticoagulant therapy contraindicating spinal anesthesia or regional nerve blocks","Infection at the site of spinal or peripheral nerve block injection","Pre-existing neurological disorders affecting sensory or motor function","Severe hepatic or renal insufficiency","Chronic opioid use for more than 3 months prior to surgery"],"whatHappens":"If you join, the listed intervention(s) are Intrathecal Morphine, Pericapsular Nerve Group Block, or Dexamethasone. The registry lists allocation as randomized. The goal of this clinical trial is to learn which of three regional anesthesia approaches provides better pain relief and safety for older adults having planned hip replacement surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Poznan. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.507Z"},{"nctId":"NCT07584226","title":"A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors","officialTitle":"A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Relay Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1/2 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors.","conditions":["Advanced NRAS-Mutant Melanoma","Advanced NRAS-Mutant Solid Tumors","NRAS Mutation","NRAS G12D","NRAS G13R","NRAS G13D","NRAS G12V","NRAS Q61R","NRAS Q61K","NRAS Q61L","NRAS Q61H","Advanced NRAS-mutant Colorectal Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"RLY-8161"}],"enrollment":180,"startDate":"2026-03-09","completionDate":"2029-05-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.\n* Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.\n* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n* One or more documented primary oncogenic NRAS mutation(s).\n\nExclusion Criteria:\n\n* Known activating KRAS, HRAS, BRAF, or EGFR mutation or known alterations in other driver oncogenes that are recognized as actionable oncogenic drivers for the participant's specific tumor type.\n* Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.\n* For participants with melanoma: lactate dehydrogenase (LDH) \\>2×ULN.\n* Central nervous system (CNS) metastases associated with progressive neurologic symptoms or requiring ongoing corticosteroids to control the CNS disease.","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest, LLC","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NEXT Virginia","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Relay Therapeutics, Inc","phone":"617-322-0731","email":"ClinicalTrials@relaytx.com"}],"primaryOutcomes":["Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161","Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests","Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1"],"hasResults":false,"conditionSlugs":["colorectal-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","aurora-colorado","boston-massachusetts","grand-rapids-michigan","new-york-new-york","nashville-tennessee","fairfax-virginia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing RLY-8161 for Advanced NRAS-Mutant Melanoma","inPlainEnglish":"This is a Phase 1/2 first-in-human, open-label multicenter study designed to measure the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1","Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor","Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy","Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1","One or more documented primary oncogenic NRAS mutation(s)"],"whoShouldSkip":["Known activating KRAS, HRAS, BRAF, or EGFR mutation or known alterations in other driver oncogenes that are recognized as actionable oncogenic drivers for the participant's specific tumor type","Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway","For participants with melanoma: lactate dehydrogenase (LDH) \\>2×ULN","Central nervous system (CNS) metastases associated with progressive neurologic symptoms or requiring ongoing corticosteroids to control the CNS disease"],"whatHappens":"If you join, the listed intervention(s) are RLY-8161. The registry lists allocation as randomized. This is a Phase 1/2 first-in-human, open-label multicenter study designed to measure the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal and other solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 180 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.819Z"},{"nctId":"NCT07587658","title":"This After Market Study is Seeing if Dupilumab Plus Usual Standard of Care (SOC) is Better Than Usual Care Alone for Adult Participants After a Severe Chronic Obstructive Pulmonary Disease (COPD) Flare-Up Requiring Hospitalization","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy of Dupilumab Added on to Standard of Care (SOC) Treatment vs SOC Treatment Following Hospitalization for a COPD Exacerbation","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching a drug called dupilumab, referred to as \"study drug\". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a \"flare-up\") happening within the study treatment duration (around 90 days).\n\nThe study is looking at another research question:\n\n• What side effects may happen from taking the study drug","conditions":["Chronic Obstructive Pulmonary Disease (COPD)"],"keywords":["Moderate and/or Severe Exacerbation","Eosinophilic phenotype","Elevated blood eosinophil counts","Type 2 inflammation","dupilumab"],"interventions":[{"type":"DRUG","name":"dupilumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":754,"startDate":"2026-10-06","completionDate":"2028-07-30","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol\n2. Hospitalized or admitted to the ED \\>24 hours (from time of first admission or presentation to the ED) for acute exacerbation of COPD as primary diagnosis according to the principal investigator and exacerbation is managed by Systemic Corticosteroids (SCS) ± antibiotics and other appropriate treatments as per SOC\n3. Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital\n\nKey Exclusion Criteria:\n\n1. Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay\n2. Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol\n3. Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments\n4. Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments\n5. Cardiac-related comorbidity, as defined in the protocol\n6. Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol\n7. Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol\n\nNOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply","locations":[{"facility":"Inspira Medical Center Mullica Hill","city":"Mullica Hill","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Time to first all-cause event","Number of moderate or severe COPD exacerbations"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":["dupilumab"],"locationSlugs":["mullica-hill-new-jersey"],"enrichment":{"headline":"Phase 4: testing dupilumab for Chronic Obstructive Pulmonary Disease (COPD)","inPlainEnglish":"This study is researching a drug called dupilumab, referred to as \"study drug\". The study is focused on people diagnosed with COPD to determine if the study drug, in addition to standard of care treatment for COPD, might reduce the reoccurrence of a COPD exacerbation (a \"flare-up\") happening within the study treatment duration (around 90 days).","whoItsFor":["Ages 40 Years to any","Has a clinical diagnosis of COPD prior to randomization, as defined in the protocol","Elevated blood eosinophil counts during the current exacerbation, as defined in the protocol. The exacerbation event starts from the day Systemic Corticosteroids (SCS) ± antibiotics are administered continuously up to the day they presented to ED/hospital"],"whoShouldSkip":["Clinical evidence of pneumonia as the primary cause of admission in the investigator's opinion or acquired during hospital stay","Complicating pulmonary conditions during the 8 weeks prior to randomization which may confound treatment assessments, as defined in the protocol","Clinically significant pulmonary diseases other than COPD which may impair lung function and interfere with treatment assessments","Participants with clinically significant α-1 anti-trypsin deficiency which may impair lung function and interfere with treatment assessments","Cardiac-related comorbidity, as defined in the protocol","Treatment with invasive mechanical ventilation in-hospital during the index event, as defined in the protocol","Any biologic therapy or biologic Investigational Medicinal Product (IMP) to treat type 2 inflammatory diseases within 6 months prior to the screening visit or 5 half-lives, whichever is longer, as defined in the protocol"],"whatHappens":"If you join, the listed intervention(s) are dupilumab, or Placebo. The registry lists allocation as randomized. This study is researching a drug called dupilumab, referred to as \"study drug\".","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 754 people at Mullica Hill. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.704Z"},{"nctId":"NCT07587710","title":"A Research Study Looking Into Blood Levels of the Medicine NNC0487-0111 in the Body and How Well it is Tolerated in People With Reduced Liver Function and Normal Liver Function","officialTitle":"A Study Investigating the Pharmacokinetic Properties, Safety and Tolerability of NNC0487-0111 in Participants With Various Degrees of Hepatic Impairment and Participants With Normal Hepatic Function","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.","conditions":["Overweight","Obesity"],"keywords":[],"interventions":[{"type":"DRUG","name":"NNC0487-0111"}],"enrollment":35,"startDate":"2026-05-13","completionDate":"2027-12-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female (sex at birth).\n* Age 18-80 years (both inclusive) at the time of signing informed consent.\n* Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.","locations":[{"facility":"Summit Clinical Research s.r.o.","city":"Bratislava","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summit Clinical Research s.r.o.","city":"Malacky","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["AUC0-∞: The area under the NNC0487-0111 plasma concentration-time curve from time 0 to infinity after a single dose"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["bratislava-slovakia","malacky-slovakia"],"enrichment":{"headline":"Phase 1: testing NNC0487-0111 for Overweight","inPlainEnglish":"The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes. The aim of this study is to see if it is safe and to find out how it works in people with reduced liver function and people with normal liver function.","whoItsFor":["Ages 18 Years to 80 Years","Male or female (sex at birth)","Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator"],"whoShouldSkip":["Known or suspected hypersensitivity to study intervention(s) or related products","Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method"],"whatHappens":"If you join, the listed intervention(s) are NNC0487-0111. The registry lists allocation as randomized. The study is testing a new study medicine to treat people with overweight/obesity and type 2 diabetes.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 35 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.826Z"},{"nctId":"NCT07589244","title":"A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC","officialTitle":"A Multicenter, Open-label Phase II/III Clinical Trial of VRT106 in Combination With Camrelizumab and Apatinib in Patients With Advanced Hepatocellular Carcinoma Who Have Failed Immune Checkpoint Inhibitor Therapy","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Guangzhou Virotech Pharmaceutical Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage. The phase III study will be initiated following discussions with National Medical Products Administration (NMPA) regarding the phase III protocol, based on accumulated data from phase II including safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD).","conditions":["HCC"],"keywords":["HCC"],"interventions":[{"type":"DRUG","name":"VRT106"},{"type":"DRUG","name":"VRT106 in combination with camrelizumab and apatinib"},{"type":"DRUG","name":"Investigator's Choice of Standard of Care"}],"enrollment":66,"startDate":"2026-05-13","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily sign the informed consent form (ICF), understand the nature of this study, and agree to comply with and complete all required study procedures.\n* Be aged between 18 and 75 years (inclusive) on the date of signing the ICF, regardless of gender.\n* Have a histologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), or a clinical diagnosis of advanced HCC according to the Standard for Diagnosis and Treatment of Primary Liver Cancer(2024 Edition).\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Have an anticipated life expectancy of ≥ 3 months.\n* Have no severe hematologic, hepatic, renal, coagulation, or cardiac function abnormalities.\n\nExclusion Criteria:\n\n* Prior receipt of camrelizumab, apatinib, oncolytic viruses, or other gene therapies.\n* Receipt of other unapproved investigational drugs/devices within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose administration in this study, or immunocompromised status.\n* History of splenectomy.\n* Pregnant or breastfeeding women.","locations":[{"facility":"The Third Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liang Peng","phone":"020-85252621","email":"pliang@mail.sysu.edu.cn"},{"name":"Chan Xie","phone":"","email":""}],"primaryOutcomes":["Incidence of Dose-Limiting Toxicities"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2 / Phase 3: testing VRT106 for HCC","inPlainEnglish":"This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs. The phase II portion consists of a part A dose-escalation stage and a part B dose-expansion stage.","whoItsFor":["Ages 18 Years to 75 Years","Be aged between 18 and 75 years (inclusive) on the date of signing the ICF, regardless of gender","Have a histologically or cytologically confirmed diagnosis of advanced hepatocellular carcinoma (HCC), or a clinical diagnosis of advanced HCC according to the Standard for Diagnosis and Treatment of Primary Liver Cancer(2024 Edition)","Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1","Have an anticipated life expectancy of ≥ 3 months","Have no severe hematologic, hepatic, renal, coagulation, or cardiac function abnormalities"],"whoShouldSkip":["Prior receipt of camrelizumab, apatinib, oncolytic viruses, or other gene therapies","Receipt of other unapproved investigational drugs/devices within 4 weeks or 5 half-lives (whichever is shorter) prior to first dose administration in this study, or immunocompromised status","History of splenectomy","Pregnant or breastfeeding women"],"whatHappens":"If you join, the listed intervention(s) are VRT106, VRT106 in combination with camrelizumab and apatinib, or Investigator's Choice of Standard of Care. The registry lists allocation as randomized. This is an open-label phase II/III clinical trial enrolling patients with advanced HCC who have failed prior ICIs.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 66 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.628Z"},{"nctId":"NCT07589595","title":"A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)","officialTitle":"A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.","conditions":["Cognitive Dysfunction","Lewy Body Disease","Synucleinopathies","Amyloid"],"keywords":["Mild Cognitive Impairment","Mild Dementia","Brain Diseases","Nervous System Diseases","Neurodegenerative Diseases","Neurocognitive Disorders","Cognition Disorders","Alzheimer Disease","Cognitive Dysfunction"],"interventions":[{"type":"DRUG","name":"Donanemab"},{"type":"DRUG","name":"Placebo"}],"enrollment":350,"startDate":"2026-05-20","completionDate":"2028-08","sex":"ALL","minAge":"55 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.\n* Have least 1 core clinical feature of dementia with Lewy bodies (DLB).\n* Have a score ≥20 on Montreal Cognitive Assessment (MoCA).\n* Meet plasma P-tau217 criteria.\n* Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.\n* Have a CSF result consistent with the presence of alpha-synuclein pathology.\n* Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n\nExclusion Criteria:\n\n* Have a disease or condition that could interfere with this study or is a current serious or unstable illness.\n* Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.\n* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.\n* Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.\n* Have previously received amyloid-targeting therapy.\n* Active immunization against amyloid-beta.\n* Have a centrally read MRI that does not meet study entry criteria.\n* Have contraindication to MRI or PET scans.\n* Have any contraindication to lumbar puncture.","locations":[{"facility":"TrialSphere Corp","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HonorHealth Research Institute","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC","city":"Carlsbad","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irvine Clinical Research","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCSD - Altman Clinical and Translational Research Institute (ACTRI)","city":"La Jolla","state":"California","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuropsychiatric Research Center of Southwest Florida","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Norman Fixel Institute for Neurological Diseases (FIND)","city":"Gainesville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research ORLANDO","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRP-Kendal Lakes","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United 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Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Houston Methodist Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Texas Neurology Consultants","city":"Round Rock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Re:Cognition Health","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"EvergreenHealth","city":"Kirkland","state":"Washington","country":"United 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Hospital","city":"Kobe","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo Tokyo Koto Geriatric Medical Center","city":"Kōtoku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Katayama Medical Clinic","city":"Kurashiki","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya Ekisaikai Hospital","city":"Nagoya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital","city":"Nagoya","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Center for Geriatrics and Gerontology","city":"Ōbu","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Osaka Hospital","city":"Suita","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Institute for Geriatrics and Gerontology","city":"tabashi City","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tachikawa Hospital","city":"Tachikawa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memory Clinic Toride","city":"Toride","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yokohama Minami Kyosai Hospital","city":"Yokohama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oita University Hospital","city":"Yufu","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gangnam Severance Hospital, Yonsei University Health System","city":"Gangnam-gu","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inha University Hospital","city":"Incheon","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Namdong-gu","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hanyang University Seoul Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Konkuk University Medical Center","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ewha Womans University Mokdong Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taipei Medical University Shuang Ho Hospital","city":"New Taipei City","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"New Taipei Municipal TuCheng Hospital","city":"New Taipei City","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital","city":"Tainan","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation-Linkou Branch","city":"Taoyuan","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["chandler-arizona","scottsdale-arizona","carlsbad-california","irvine-california","la-jolla-california","palo-alto-california","englewood-colorado","stamford-connecticut","atlantis-florida","aventura-florida","delray-beach-florida","fort-myers-florida","gainesville-florida","jacksonville-florida","maitland-florida","miami-florida","ocala-florida","orlando-florida","tampa-florida","west-palm-beach-florida","winter-park-florida","indianapolis-indiana","fairway-kansas","charlestown-massachusetts","foxborough-massachusetts","plymouth-massachusetts","farmington-hills-michigan","golden-valley-minnesota","rochester-minnesota","bolivar-missouri","portland-oregon","philadelphia-pennsylvania","beaumont-texas","dallas-texas","houston-texas","round-rock-texas","san-antonio-texas","fairfax-virginia","kirkland-washington","bunky-city-japan","fujisawa-japan","himeji-japan","inage-japan","kawasaki-japan","kobe-japan","k-toku-japan","kurashiki-japan","nagoya-japan","bu-japan","suita-japan","tabashi-city-japan","tachikawa-japan","toride-japan","yokohama-japan","yufu-japan","gangnam-gu-south-korea","incheon-south-korea","namdong-gu-south-korea","seoul-south-korea","new-taipei-city-taiwan","tainan-taiwan","taipei-taiwan","taoyuan-taiwan"],"enrichment":{"headline":"Phase 2: testing Donanemab for Cognitive Dysfunction","inPlainEnglish":"The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.","whoItsFor":["Ages 55 Years to 85 Years","Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months","Have least 1 core clinical feature of dementia with Lewy bodies (DLB)","Have a score ≥20 on Montreal Cognitive Assessment (MoCA)","Meet plasma P-tau217 criteria","Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology","Have a CSF result consistent with the presence of alpha-synuclein pathology"],"whoShouldSkip":["Have a disease or condition that could interfere with this study or is a current serious or unstable illness","Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study","Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study","Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions","Have previously received amyloid-targeting therapy","Active immunization against amyloid-beta","Have a centrally read MRI that does not meet study entry criteria"],"whatHappens":"If you join, the listed intervention(s) are Donanemab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 350 people at 72 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.331Z"},{"nctId":"NCT07591246","title":"Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction","officialTitle":"Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Cairo University","sponsorClass":"OTHER","summary":"females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)","conditions":["Polycystic Ovary Syndrome","Non-Alcoholic Fatty Pancreatic Disease","Subclinical hypothyroïdism"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"physical exercise program"},{"type":"OTHER","name":"usual care"}],"enrollment":40,"startDate":"2026-03-07","completionDate":"2026-12-30","sex":"FEMALE","minAge":"20 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PCOS\n* fattty pancrease (non-alcoholic)\n* subclinical hypothyroid (signifcant with thyroid stimauted horomone more than 10 mIU/L) and normal non-disordered free thyroxine horomones\n\nExclusion Criteria:\n\n* cardiac disesase\n* renal diseases\n* respiratory disease","locations":[{"facility":"Cairo Unoversity","city":"Giza","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ali MA Ismail, lecturer","phone":"01005154209","email":"ali.mohamed@pt.cu.edu.eg"},{"name":"ali mohamed","phone":"01031321109","email":"allooka2012@gmail.com"}],"primaryOutcomes":["Dehydroepiandrosterone"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["giza-egypt"],"enrichment":{"headline":"Not a traditional drug phase: physical exercise program for Polycystic Ovary Syndrome","inPlainEnglish":"Females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)","whoItsFor":["Ages 20 Years to 40 Years","Women only","fattty pancrease (non-alcoholic)","subclinical hypothyroid (signifcant with thyroid stimauted horomone more than 10 mIU/L) and normal non-disordered free thyroxine horomones"],"whoShouldSkip":["respiratory disease"],"whatHappens":"If you join, the listed intervention(s) are physical exercise program, or usual care. The registry lists allocation as randomized. Females of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Giza. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.798Z"},{"nctId":"NCT07592169","title":"Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia","officialTitle":"Confirmatory Efficacy Trial to Confirm the Effects of Gamma EEG-Neurofeedback on Working Memory in Schizophrenia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"This study is a confirmatory, double-blind, placebo-controlled randomized clinical trial (RCT) testing whether gamma EEG neurofeedback (EEG-NFB) improves working memory in adults with schizophrenia or schizoaffective disorder. Participants are randomly assigned to receive either active gamma EEG-NFB (real-time feedback of frontal gamma brain activity) or sham EEG-NFB (false pre-recorded feedback), twice weekly for 12 weeks. Working memory (N-back task), brain gamma coherence, and everyday community functioning are assessed at baseline, mid-treatment, end of treatment, and follow-up.","conditions":["SCHIZOPHRENIA 1 (Disorder)","Schizoaffecitve Disorder"],"keywords":["schizophrenia","neurofeedback","EEG","gamma oscillations","working memory","randomized controlled trial","n-back","community functioning"],"interventions":[{"type":"BEHAVIORAL","name":"EEG Neurofeedback"}],"enrollment":104,"startDate":"2026-11-05","completionDate":"2029-11-30","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) 2. Age 18-55 years 3. Clinically stable: no psychiatric hospitalization in the 3 months prior to enrollment 4. No change in antipsychotic medication type or dosage within 4 weeks prior to baseline assessment 5. Ascertained to be clinically and medically stable by a study investigator 6. Does not meet DSM-5 diagnostic criteria for bipolar disorder or current major depressive episode 7. No electroconvulsive therapy (ECT) within 6 months of baseline assessment 8. Able to read and speak English (corrected vision or hearing aids acceptable) 9. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* 1\\. Self-reported history of seizure disorder 2. Diagnosed with multiple sclerosis 3. History of stroke or major vascular disease, including insulin-dependent diabetes mellitus 4. HIV/AIDS diagnosis 5. Current (not past) major depressive episode 6. Substance use disorder other than nicotine use disorder or caffeine use disorder in the past year 7. Brain cancer (primary or metastatic) 8. Prior head injury involving loss of consciousness 9. Inability to read or speak English 10. Color blindness that interferes with administration of study assessments 11. Neuropsychological or cognitive testing in the past 6 months using the same measures as this study 12. Score on Letter-Number Sequencing greater than 1 standard deviation above the age-normed mean","locations":[{"facility":"UC San Diego School of Medicine","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Autumn Harris Study Coordinator","phone":"858-267-2257","email":"fnlab@health.ucsd.edu"},{"name":"Jason Holden Lab Manager, PhD","phone":"858-267-2257","email":"fnlab@health.ucsd.edu"}],"primaryOutcomes":["N-back 2-back target accuracy (d-prime)","Frontal gamma coherence during N-back task","Independent Living Skills Survey (ILSS) total score"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Phase 2: EEG Neurofeedback for SCHIZOPHRENIA 1 (Disorder)","inPlainEnglish":"This study is a confirmatory, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment randomly assigned clinical trial (RCT) testing whether gamma EEG neurofeedback (EEG-NFB) improves working memory in adults with schizophrenia or schizoaffective disorder. Participants are randomly assigned to receive either active gamma EEG-NFB (real-time feedback of frontal gamma brain activity) or sham EEG-NFB (false pre-recorded feedback), twice weekly for 12 weeks.","whoItsFor":["Ages 18 Years to 55 Years"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are EEG Neurofeedback. The registry lists allocation as randomized. This study is a confirmatory, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment randomly assigned clinical trial (RCT) testing whether gamma EEG neurofeedback (EEG-NFB) improves working memory in adults with schizophrenia or schizoaffective disorder.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 104 people at La Jolla. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.033Z"},{"nctId":"NCT07592546","title":"Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss","officialTitle":"Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Alain Dagher","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn about the nature of brain abnormalities associated with excess body fat in healthy adults aged 35-55. The main questions it aims to answer are:\n\n* Will excessive fat be associated with brain abnormalities on MRI measures?\n* Will weight loss change brain health on MRI measures?\n\nParticipants will:\n\n* Self-administer study drug, semaglutide, once a week for 80 weeks\n* Complete metabolic and basic body measurements\n* Complete cognitive, mood, and dietary assessments\n* Complete questionnaires\n* Undergo MRIs","conditions":["Class I/II Obesity"],"keywords":["weight loss","BMI","Obesity","overweight","obese","semaglutide","Ozempic","Wegovy","GLP-1"],"interventions":[{"type":"DRUG","name":"semaglutide"}],"enrollment":240,"startDate":"2026-10-21","completionDate":"2028-12-01","sex":"ALL","minAge":"35 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nKey inclusion criteria for obese group:\n\n* Individuals of age 35-55 years with BMI 27 - 40 kg/m2\n* Able to provide informed consent\n* Willing to self-inject semaglutide and follow study procedures for its entire duration.\n\nKey inclusion criteria for lean control group:\n\n* Individuals of age 35-55 years with BMI 20 - 25 kg/m2\n* Able to provide informed consent\n\nExclusion Criteria for both groups:\n\n* Current type 2 diabetes mellitus;\n* Neurological disorders affecting the CNS;\n* History or family history of medullary thyroid carcinoma or MEN2 syndrome\n* CNS-active medications (outside of medications used to control psychiatric disorders);\n* Poorly controlled psychiatric disorders including major depression or previous suicidality;\n* Class III obesity (BMI\\>40 or BMI\\>35 with complications) as these individuals are eligible for bariatric surgery in Canada and will be referred for appropriate medical care;\n* Clinical safety blood measures indicative of a medical issue.\n* History of weight change \\> 5 kg in past 90 days;\n* History of pancreatitis\n* Previous or planned bariatric surgery;\n* Use of another weight loss medication during trial participation and within 90 days before enrolment;\n* History of serious medical illness, monogenic obesity, uncontrolled hypertension (sBP\\>160 mmHg, dBP\\>100 mmHg), active malignancy, illicit substance use, cigarette smoking, diagnosed eating disorder, as listed in the study protocol associated with; Other obesity comorbidities, e.g. hypertension, pre-diabetes (HbA1C = 6% to 6.4%), hyperlipidemia, controlled depressive disorder or anxiety, ADHD, and polycystic ovary syndrome, will not be exclusion criteria as this would reduce the representativeness of our sample.\n* Female subjects of childbearing potential (i.e., a premenopausal female capable of becoming pregnant) are eligible to enroll if they are either sexually inactive/abstinent or using an effective contraceptive from screening until 4 weeks after the last dose. Medically accepted contraception are hormonal implants, hormonal patches, IDU, diaphragm and spermicide, cervical cape with spermicide, and condom with spermicide.","locations":[{"facility":"The Montreal Neurological Institute-Hospital","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael Pileggi, M.Sc.","phone":"514-396-2085","email":"michael.pileggi@mcgill.ca"},{"name":"Filip Morys","phone":"","email":"filip.morys@mcgill.ca"}],"primaryOutcomes":["Serum C-reactive Protein (CRP)","Serum Pro-inflammatory Cytokines (Interleukin-6, TNF-α, Interleukin-1β, and IL-1 Receptor Antagonist)","Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)","Fasting Plasma Glucose","Glycated Hemoglobin A1c (HbA1c)","Serum Leptin","Serum Ghrelin","Serum Adiponectin","Fasting Serum Insulin","Serum Glucagon-Like Peptide-1 (GLP-1)","Serum C-peptide","Serum Lipid Panel (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides, and Non-Esterified Fatty Acids [NEFA])","Serum Apolipoprotein B (ApoB)","Red Blood Cell Phospholipid Fatty Acid Composition","Cerebral Blood Flow as Measured by Pseudo-Continuous Arterial Spin Labeling (pCASL) MRI","Oxygen Extraction Fraction (OEF) as Measured by Quantitative Susceptibility Mapping (QSM) and T2* MRI","Cerebral Metabolic Rate of Oxygen (CMRO₂) as Measured by QSM and T2* MRI","Cortical Thickness as Measured by Structural MRI","Grey Matter Volume as Measured by Structural MRI","Grey Matter Surface Area as Measured by Structural MRI","White Matter Fractional Anisotropy (FA) as Measured by Diffusion Tensor Imaging (DTI)","White Matter Mean Diffusivity (MD) as Measured by Diffusion Tensor Imaging (DTI)","White Matter Microstructure as Measured by NODDI (intracellular volume fraction [ICVF], isotropic volume fraction [ISOVF], and Orientation Dispersion Index [ODI])","White Matter Hyperintensity Volume as Measured by FLAIR MRI","Cerebrovascular Reactivity (CVR) as Measured by BOLD fMRI with End-Tidal CO₂ (EtCO₂) Challenge","Neuroinflammation proxy as Measured by T2* relaxation times","Neuromelanin Contrast Ratio in the Substantia Nigra as Measured by Neuromelanin-Sensitive MRI","Intracranial Artery Lumen Diameter as Measured by Time-of-Flight MRA","Body Mass Index (BMI)","Waist Circumference, Hip Circumference","Waist-to-height ratio, Waist-to-hip ratio","Visceral Adipose Tissue as Measured by MRI","Subcutaneous Adipose Tissue as Measured by MRI","Body Composition"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Phase 4: testing semaglutide for Class I/II Obesity","inPlainEnglish":"The goal of this clinical trial is to learn about the nature of brain abnormalities associated with excess body fat in healthy adults aged 35-55. The main questions it aims to answer are: * Will excessive fat be associated with brain abnormalities on MRI measures?","whoItsFor":["Ages 35 Years to 55 Years","Key who can join for obese group:","Individuals of age 35-55 years with body-mass index (BMI) 27 - 40 kg/m2","Willing to self-inject semaglutide and follow study procedures for its entire duration","Key who can join for lean control group:","Individuals of age 35-55 years with body-mass index (BMI) 20 - 25 kg/m2"],"whoShouldSkip":["Current type 2 diabetes mellitus;","Neurological disorders affecting the CNS;","History or family history of medullary thyroid carcinoma or MEN2 syndrome","CNS-active medications (outside of medications used to control psychiatric disorders);","Poorly controlled psychiatric disorders including major depression or previous suicidality;","Class III obesity (body-mass index (BMI)\\>40 or body-mass index (BMI)\\>35 with complications) as these individuals are eligible for bariatric surgery in Canada and will be referred for appropriate medical care;","Clinical safety blood measures indicative of a medical issue"],"whatHappens":"If you join, the listed intervention(s) are semaglutide. The registry lists allocation as randomized. The goal of this clinical trial is to learn about the nature of brain abnormalities associated with excess body fat in healthy adults aged 35-55.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 240 people at Montreal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.727Z"},{"nctId":"NCT07592689","title":"A Phase 3 Trial of DT120 for Major Depressive Disorder (Ascend)","officialTitle":"A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40-Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral DT120 Compared to Placebo in the Treatment of Adults With Major Depressive Disorder - Ascend","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Definium Therapeutics US, Inc.","sponsorClass":"INDUSTRY","summary":"A Phase 3 Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Major Depressive Disorder - Ascend","conditions":["Major Depressive Disorder"],"keywords":[],"interventions":[{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"DT120"}],"enrollment":165,"startDate":"2026-05-10","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of MDD per DSM-5\n2. Male or female aged 18 to 74\n3. Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration\n4. MADRS Total Score ≥26\n5. CGI-S Score ≥4\n\nExclusion Criteria:\n\n1. Certain psychiatric disorders (other than major depressive disorder)\n2. First degree relative with or lifetime history of a psychotic disorder or bipolar disorder\n3. Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine\n4. Any clinically significant unstable illness","locations":[{"facility":"Preferred Research Partners, Inc.","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ATP Clinical Research Orange County","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kadima Neuropsychiatry Institute","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psychedelic Science Institute","city":"Santa Monica","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mountain View Clinical Research, Inc","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC (Jacksonville)","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research (Maitland)","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC (Orlando)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research (Tampa)","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel - Atlanta Center for Medical Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel - iResearch Atlanta","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel - iResearch Savannah","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uptown Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Boston","city":"Boston","state":"Massachusetts","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Watertown","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitalix Clinical","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arch Clinical Trials, LLC","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Redbird Research","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Harlem","city":"New York","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Coastal Carolina Research","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Trial Partners","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Clinical Research","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inner Space Research","city":"Orem","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memory Clinic Inc.","city":"Bennington","state":"Vermont","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Neuropsychiatric Treatment Center","city":"Seattle","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Definium Therapeutics Clinical Trials Info Requests","phone":"1-332-282-0479","email":"clinicaltrials@definiumtx.com"}],"primaryOutcomes":["Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","orange-california","san-diego-california","santa-monica-california","denver-colorado","jacksonville-florida","maitland-florida","orlando-florida","tampa-florida","atlanta-georgia","decatur-georgia","savannah-georgia","chicago-illinois","boston-massachusetts","worcester-massachusetts","st-louis-missouri","las-vegas-nevada","new-york-new-york","philadelphia-pennsylvania","north-charleston-south-carolina","austin-texas","draper-utah","orem-utah","bennington-vermont","seattle-washington"],"enrichment":{"headline":"Phase 3: testing DT120 for Major Depressive Disorder","inPlainEnglish":"A Phase 3 neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to dummy treatment (placebo) in Major Depressive Disorder - Ascend","whoItsFor":["Ages 18 Years to 74 Years","Diagnosis of major depression per DSM-5","Male or female aged 18 to 74","Currently experiencing a major depressive episode (MDE) of ≥8 weeks and ≤24 months duration","MADRS Total Score ≥26"],"whoShouldSkip":["Certain psychiatric disorders (other than major depressive disorder)","First degree relative with or lifetime history of a psychotic disorder or bipolar disorder","Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine","Any clinically significant unstable illness"],"whatHappens":"If you join, the listed intervention(s) are Placebo, or DT120. The registry lists allocation as randomized. A Phase 3 neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to dummy treatment (placebo) in Major Depressive Disorder - Ascend","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 165 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.104Z"},{"nctId":"NCT07594119","title":"Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Rapport Therapeutics Inc.","sponsorClass":"INDUSTRY","summary":"This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.","conditions":["Focal Seizure","Epilepsy","Focal Epilepsy"],"keywords":["Focal Preserved Consciousness","Focal Impaired Consciousness"],"interventions":[{"type":"DRUG","name":"RAP-219"},{"type":"DRUG","name":"RAP-219"},{"type":"OTHER","name":"Placebo"}],"enrollment":312,"startDate":"2026-09-01","completionDate":"2029-07","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 - 75\n2. BMI 18-45 kg/m2\n3. Diagnosis of focal epilepsy for ≥24 months prior to Visit 1\n4. Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis\n5. Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs\n6. Ability to keep accurate daily focal seizure records using an e-diary\n\nExclusion Criteria:\n\n1. Known hypersensitivity or prior exposure to RAP-219.\n2. Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur\n3. Anticipated need for surgery during the study period\n4. Medical history of any of the following:\n\n   1. generalized epilepsy\n   2. focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type\n   3. psychogenic nonepileptic seizure (PNES)\n   4. status epilepticus or seizure clusters (when individual seizures cannot be counted) within 12 months prior to Visit 1 (Day -56).\n   5. epilepsy surgery within 12 months prior to Visit 1 (Day -56).\n5. Participation in another clinical study of an investigational product within 12 weeks or 5 half-lives of this other investigational product","locations":[{"facility":"Clinic for Neurology","city":"Huntsville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Colorado Springs Neurological Associates","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Serenity Research Center, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hawaii Pacific Neuroscience","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Re:Cognition Health-Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lenox Hill Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baylor College of Medicine","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center in Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Health Clinical School, Monach University Box Hill","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rapport Medical","phone":"857 323 9048","email":"RAP-219-FOS@rapportrx.com"}],"primaryOutcomes":["Median Percent Change in Seizure Frequency"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["huntsville-alabama","bentonville-arkansas","colorado-springs-colorado","maitland-florida","miami-florida","honolulu-hawaii","chicago-illinois","omaha-nebraska","new-york-new-york","raleigh-north-carolina","nashville-tennessee","houston-texas","melbourne-australia"],"enrichment":{"headline":"Phase 3: testing RAP-219 for Focal Seizure","inPlainEnglish":"This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures. This study is being conducted to determine if RAP-219 is safe and effective in reducing focal seizure frequency.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of focal epilepsy for ≥24 months prior to Visit 1","Report from at least 1 brain MRI or CT scan and 1 EEG study, each completed within 10 years prior to Visit 1, consistent with focal epilepsy diagnosis","Concomitant use of between 1 and 3, inclusive, antiseizure medication(s) ASM(s) as maintenance, not including rescue or pro re nata (PRN) ASMs","Ability to keep accurate daily focal seizure records using an e-diary"],"whoShouldSkip":["Known hypersensitivity or prior exposure to RAP-219","Unstable or uncontrolled serious medical, neurologic (other than focal epilepsy), or psychiatric condition that is ongoing or considered likely to recur","Anticipated need for surgery during the study period","Medical history of any of the following:","generalized epilepsy","focal preserved consciousness without observable manifestations (also known as focal aware nonmotor) as the participant's only seizure type","psychogenic nonepileptic seizure (PNES)"],"whatHappens":"If you join, the listed intervention(s) are RAP-219, RAP-219, or Placebo. The registry lists allocation as randomized. This is a clinical research study for an investigational drug called RAP-219 in adult participants with focal seizures.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 312 people at 14 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.900Z"},{"nctId":"NCT07594236","title":"Phase 1 Study of C.001 in Retinal Degeneration","officialTitle":"A Phase I Single-Center Open-label Study of C.001 in Patients With Significant Retinal Pigment Epithelium Mediated Maculopathy (RMM)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Cellio Therapeutics Inc","sponsorClass":"INDUSTRY","summary":"This is a first-in-human Phase 1 study evaluating the safety and tolerability of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium.\n\nParticipants will receive a single administration of C.001 delivered by subretinal injection. The study will evaluate three dose levels in a sequential manner.\n\nThe primary objective is to assess the safety of C.001 over a 3-month period following administration. Participants will be followed for up to 12 months to further evaluate safety and explore changes in visual function and retinal structure.","conditions":["Geographic Atrophy","Stargardt Disease","RPE-mediated Maculopathy","Age Related Macular Degeneration"],"keywords":["macular degeneration","macular distrophy","C.001"],"interventions":[{"type":"BIOLOGICAL","name":"Injection"}],"enrollment":15,"startDate":"2026-04-07","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of retinal disease associated with retinal pigment epithelium degeneration (e.g., geographic atrophy or Stargardt disease)\n* Visual acuity within protocol-defined limits\n* Stable ocular condition prior to enrollment\n* Medically suitable for ophthalmic surgery and anesthesia\n* Willingness to comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Active or prior choroidal neovascularization (CNV)\n* Recent myocardial infarction or significant uncontrolled cardiovascular disease\n* Uncontrolled glaucoma\n* Significant ocular inflammatory disease\n* Recent intraocular surgery within protocol-defined timeframe\n* Active systemic infection\n* Poorly controlled diabetes (e.g., HbA1c \\>8.5%)\n* Participation in another investigational study within 3 months prior to screening","locations":[{"facility":"Retina Vision Consultants","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palo Alto Medical Foundation","city":"Palo Alto","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants Medical Group","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trial Administrator","phone":"999-999-9999","email":"trials@celliotherapeutics.com"}],"primaryOutcomes":["Incidence of Ocular and Systemic Adverse Events"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["beverly-hills-california","palo-alto-california","sacramento-california"],"enrichment":{"headline":"Phase 1: testing Injection for Geographic Atrophy","inPlainEnglish":"This is a first-in-human Phase 1 study evaluating the whether it is safe and how hard side effects are to live with of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium. Participants will receive a single administration of C.001 delivered by subretinal injection.","whoItsFor":["Ages 18 Years to any","Diagnosis of retinal disease associated with retinal pigment epithelium degeneration (e.g., geographic atrophy or Stargardt disease)","Visual acuity within protocol-defined limits","Stable ocular condition prior to enrollment","Medically suitable for ophthalmic surgery and anesthesia","Willingness to comply with study procedures and follow-up"],"whoShouldSkip":["Active or prior choroidal neovascularization (CNV)","Recent myocardial infarction or significant uncontrolled cardiovascular disease","Uncontrolled glaucoma","Significant ocular inflammatory disease","Recent intraocular surgery within protocol-defined timeframe","Active systemic infection","Poorly controlled diabetes (e.g., HbA1c \\>8.5%)"],"whatHappens":"If you join, the listed intervention(s) are Injection. The registry lists allocation as randomized. This is a first-in-human Phase 1 study evaluating the whether it is safe and how hard side effects are to live with of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at 3 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.142Z"},{"nctId":"NCT07594483","title":"Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium","officialTitle":"Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Motif Neurotech, Inc.","sponsorClass":"INDUSTRY","summary":"The objective of this study is to evaluate the safety, tolerability, and preliminary efficacy of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).","conditions":["Major Depressive Disorder"],"keywords":["Depression","Treatment-resistant depression"],"interventions":[{"type":"DEVICE","name":"Motif XCS System"}],"enrollment":20,"startDate":"2026-10-02","completionDate":"2027-12","sex":"ALL","minAge":"22 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (MDD) and is currently experiencing a major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)\n2. Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20\n3. Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes in at least one episode of major depressive disorder, according to the Antidepressant Treatment History Form (ATHF)\n4. Is willing and able to provide written informed consent\n5. Is 22-85 years of age\n6. Is willing and able to comply with the protocol, including follow-up visits\n7. Has been on a stable psychiatric treatment regimen for 30 days before the study screening MADRS and is willing to maintain a stable psychiatric treatment regimen through the Week 4 follow-up visit\n\nExclusion Criteria:\n\n1. Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator\n2. Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant\n3. Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)\n4. In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient\n5. Is currently taking blood thinners and cannot be taken off blood thinners\n6. Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit\n7. Has taken hallucinogenic or dissociative medications in the past 30 days or is planning on taking hallucinogenic or dissociative medications for the treatment of mood or anxiety disorders before the 4-week follow-up visit\n8. Has a history of bipolar disorder\n9. Has a history of schizophrenia, schizoaffective disorder, or other psychotic disorder\n10. Has psychotic features in the current depressive episode\n11. Has a chronic and clinically significant neurological disorder (epilepsy, dementia, delirium, amnestic disorder, brain tumor), or neuroimaging findings that would potentially impact the efficacy of treatment (e.g., extensive white matter disease, demyelinating lesions, atrophy, brain tumor)\n12. Currently taking medication that would alter the seizure threshold, increasing potential seizure risks\n13. Has a history of brain injury that resulted in current cognitive impairment\n14. Has a history of bony disorders that impact the safe and effective use of the device as well as device implantation\n15. Has a history of skin disorders that impact the safe and effective use of the device as well as device implantation\n16. Has failed all attempts to achieve at least 50% reduction in depressive symptoms after completion of approved treatment courses of electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) for treatment of MDD\n17. Is planning to receive any other neuromodulation therapy during the study\n18. Meets the DSM-5 criteria for alcohol use disorder or other substance use disorder (not including tobacco/nicotine) within 12 months prior to study enrollment or, in the opinion of the investigator, is using illicit drugs recreationally or therapeutically which could impact the safety or effectiveness of the therapy\n19. Female who is pregnant at the time of inclusion, or planning to become pregnant during the duration of the study, or not willing to use an effective method of birth control\n20. Has a life expectancy less than 12 months\n21. In the opinion of the investigator, is considered to be acutely suicidal (e.g., Type 4 or 5 on the Columbia-Suicide Severity Rating Scale \\[C-SSRS\\])\n22. In the investigator's opinion, any known comorbidity that would complicate the assessment of safety or prevent participation in follow-up visits\n\nBefore implantation of the Motif Digitally Programmable Over-Brain Therapeutic (DOT) Implant, subjects must continue to meet all study eligibility criteria. Subjects must also meet the following additional criteria:\n\n1. Psychiatric treatment regimen has remained stable\n2. Has skull thickness ≥5.5 mm and ≤15.5 mm over the implant target","locations":[{"facility":"Emory Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brain Health Consultants and TMS Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brandon Thio","phone":"201-381-1534","email":"support@motifneuro.tech"},{"name":"Ted Meehan","phone":"","email":"ted.meehan@brightresearch.com"}],"primaryOutcomes":["Incidence of device and/or procedure-related adverse events (AEs)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["atlanta-georgia","iowa-city-iowa","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Motif XCS System for Major Depressive Disorder","inPlainEnglish":"The objective of this study is to measure the safety, tolerability, and preliminary how well it works of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).","whoItsFor":["Ages 22 Years to 85 Years","Has a diagnosis of unipolar non-psychotic Major Depressive Disorder (major depression) and is currently experiencing a major depressive episode (MDE) as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-5)","Has a screening Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥20","Has not had a sustained response to 2 or more adequately dosed antidepressant treatments from at least 2 different antidepressant treatment classes in at least one episode of major depressive disorder, according to the Antidepressant Treatment History Form (ATHF)","Is 22-85 years of age","Is willing and able to comply with the protocol, including follow-up visits","Has been on a stable psychiatric treatment regimen for 30 days before the study screening MADRS and is willing to maintain a stable psychiatric treatment regimen through the Week 4 follow-up visit"],"whoShouldSkip":["Has a cranial implant (with the exception of dental implants), neurostimulator, implanted medication pump, spinal cord stimulator, or pacemaker/implantable cardioverter-defibrillator","Has knowledge of planned magnetic resonance imaging (MRIs) in the next 12 months, after implant","Is unable to undergo imaging with computed tomography (CT), magnetic resonance imaging (MRI), diffusion tensor imaging (DTI), or functional magnetic resonance imaging (fMRI)","In the opinion of the investigator, the implant and therapy pose an unacceptable surgical or medical risk to the patient","Is currently taking blood thinners and cannot be taken off blood thinners","Has taken ketamine or esketamine in the past 30 days or is planning on taking ketamine or esketamine before the 4-week follow-up visit","Has taken hallucinogenic or dissociative medications in the past 30 days or is planning on taking hallucinogenic or dissociative medications for the treatment of mood or anxiety disorders before the 4-week follow-up visit"],"whatHappens":"If you join, the listed intervention(s) are Motif XCS System. The registry lists allocation as na. The objective of this study is to measure the safety, tolerability, and preliminary how well it works of the Motif eXternally powered Cortical Stimulation (XCS) System when used as indicated for treatment-resistant depression (TRD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.108Z"},{"nctId":"NCT07595549","title":"A Study to Learn About the Study Medicine Called Berobenatide (PF-08653944) in People With Overweight or Obesity","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF-08653944 IN ADULTS WITH OVERWEIGHT OR OBESITY (VESPER-6)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight. People in this study may also have type 2 diabetes.\n\nAbout 950 adults will be in this study. Berobenatide will be compared to a placebo. A placebo does not have any medicine in it but looks just like the medicine being studied. Berobenatide or placebo is given by a shot under the skin in the belly area. The objective of the study is to compare the experiences of people receiving berobenatide to those of the people who do not to assess if the study medicine is effective and safe.\n\nPeople will take part in this study for about 20 months. During this time, they will have about 15 study visits at the site. They will also have 2 study visits over the phone.","conditions":["Obesity","Overweight and/or Obesity","Overweight"],"keywords":["Overnutrition","Nutrition Disorders","Diabetes Mellitus, Type 2","Type 2 Diabetes","Body Weight","Diabetes Mellitus","Glucose Metabolism Disorders","Endocrine System Diseases","Overweight","Obesity","Nutritional and Metabolic Diseases","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Metabolic Diseases"],"interventions":[{"type":"DRUG","name":"PF-08653944"},{"type":"OTHER","name":"Placebo"}],"enrollment":954,"startDate":"2026-06-10","completionDate":"2028-05-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥18 years.\n* BMI of: ≥30 kg/m2 or ≥27.0 kg/m2 to \\<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.\n\nExclusion Criteria:\n\n* Have a self-reported body weight change greater than 5% within 90 days prior to Screening.\n* Diagnosis of type 1 diabetes or any other form of diabetes other than T2D.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).","locations":[{"facility":"San Fernando Valley Health Institute","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research California, LLC","city":"Escondido","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ImmuniMet, LLC","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials Research","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Clinical Investigators, Inc.","city":"Tustin","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research, Inc.","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Retina Specialists","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nature Coast Clinical Research","city":"Crystal River","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Coast Eye Institute","city":"Lecanto","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Broward Research","city":"Miramar","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"West Coast Medical Associates","city":"New Port Richey","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Center for Diabetes, Obesity and Metabolism Inc","city":"Pembroke Pines","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Crosse Research Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health - Family Medicine Administration","city":"Evanston","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health- Endocrinology Research","city":"Skokie","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MediSphere Medical Research Center, LLC","city":"Evansville","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Louisville","state":"Kentucky","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Louisville Retina, PLLC","city":"Louisville","state":"Kentucky","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Ascension Saint Agnes Heart Care","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aa Mrc Llc","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Of Nebraska Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albuquerque Clinical Trials, Inc.","city":"Albuquerque","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine - Comprehensive Weight Control Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research, LLC","city":"Rochester","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Medication Management, LLC","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Wilmington","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jeffrey Coleman, OD","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Eye Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Mt. Auburn","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PlanIt Research, LLC (Monitoring Room)","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PlanIt Research, LLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VIP Trials","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"York Clinical Research, LLC","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associação de Amparo à Saúde, Ensino e Pesquisa","city":"Brasília","state":"Federal District","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saraiva & Berlinger Ltda EPP Instituto de Pesquisa Clínica de Campinas","city":"Campinas","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundação Faculdade Regional de Medicina de São José do Rio Preto","city":"São José do Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"CEPIC - Centro Paulista de Investigação Clínica","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clínicas da Faculdade de Medicina da USP","city":"São Paulo","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ocean West Research Clinic","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GA Research Associates Ltd.","city":"Moncton","state":"New Brunswick","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Winterberry Research Inc.","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Wharton Medical Clinic Clinical Trials Inc","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Canadian Phase Onward Inc.","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes","city":"Saint-Herblain","state":"Loire Atlantique","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Montpellier - Hôpital Lapeyronie","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Georges Pompidou European hospital","city":"Paris","state":"Île-de-France Region","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinische Forschung Schwerin GmbH","city":"Schwerin","state":"Mecklenburg-Vorpommern","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Schleswig-Holstein, Campus Lübeck","city":"Lübeck","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"RED - lnstitut für medizinische Forschung GmbH","city":"Oldenburg in Holstein","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS MultiMedica","city":"Sesto San Giovanni","state":"Milano","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Azienda Ospedaliero Universitaria di Bologna, Policlinico di Sant'Orsola","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Università degli Studi \"G. d'Annunzio\" Chieti-Pescara","city":"Chieti","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone","city":"Palermo","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Campus Bio-Medico","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Corporation Heishinkai OCROM Clinic","city":"Suita","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Center Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo-Eki Center-Building Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Corporation Heishinkai ToCROM Clinic","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - INCMNSZ","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Diabetes Obesidad y Nutrición S.C.","city":"Cuernavaca","state":"Morelos","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMED Investigación Médica SC","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eukarya PharmaSite","city":"Monterrey","state":"Nuevo León","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"ZDROWIE OSTEO-MEDIC s.c. L i A Racewicz, A i J Supronik","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Penta Hospitals Badania Kliniczne sp. z o.o.","city":"Gdansk","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna","city":"Lublin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Zdrowia Metabolicznego Pawel Bogdanski","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne AD-MED Sp. z o.o.","city":"Wroclaw","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Konyang University Hospital","city":"Daejeon","state":"Daejeon","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hallym University Sacred Heart Hospital","city":"Anyang-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pusan National University Yangsan Hospital","city":"Yangsan","state":"Gyeongsangnam-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gachon University Gil Medical Center","city":"Incheon","state":"Incheon-gwangyeoksi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kangbuk Samsung Hospital","city":"Seoul","state":"Seoul- Teukbyeolsi","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramón y Cajal","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital San Rafael","city":"A Coruña","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Marañon","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario QuironSalud Madrid","city":"Pozuelo de Alarcón","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Percent change from baseline in body weight"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["canoga-park-california","escondido-california","modesto-california","sacramento-california","tustin-california","walnut-creek-california","west-hills-california","crystal-river-florida","lecanto-florida","miramar-florida","new-port-richey-florida","pembroke-pines-florida","chicago-illinois","evanston-illinois","skokie-illinois","evansville-indiana","louisville-kentucky","baltimore-maryland","flint-michigan","omaha-nebraska","albuquerque-new-mexico","new-york-new-york","rochester-new-york","greensboro-north-carolina","wilmington-north-carolina","cincinnati-ohio","houston-texas","san-antonio-texas","norfolk-virginia","bras-lia-brazil","campinas-brazil","s-o-jos-do-rio-preto-brazil","s-o-paulo-brazil","surrey-canada","moncton-canada","hamilton-canada","toronto-canada","saint-herblain-france","montpellier-france","paris-france","schwerin-germany","l-beck-germany","oldenburg-in-holstein-germany","sesto-san-giovanni-italy","bologna-italy","chieti-italy","palermo-italy","roma-italy","suita-japan","chuo-ku-japan","shinjuku-ku-japan","mexico-city-mexico","cuernavaca-mexico","monterrey-mexico","bialystok-poland","gdansk-poland","lublin-poland","poznan-poland","wroclaw-poland","daejeon-south-korea","anyang-si-south-korea","yangsan-south-korea","incheon-south-korea","seoul-south-korea","madrid-spain","a-coru-a-spain","pozuelo-de-alarc-n-spain","seville-spain"],"enrichment":{"headline":"Phase 3: testing PF-08653944 for Obesity","inPlainEnglish":"The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944). This may help people with overweight or obesity lose weight.","whoItsFor":["Ages 18 Years to any","body-mass index (BMI) of: ≥30 kg/m2 or ≥27.0 kg/m2 to \\<30.0 kg/m2 and must have at least 1 of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D"],"whoShouldSkip":["Have a self-reported body weight change greater than 5% within 90 days prior to Screening","Diagnosis of type 1 diabetes or any other form of diabetes other than T2D","History of acute or chronic pancreatitis","Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2)"],"whatHappens":"If you join, the listed intervention(s) are PF-08653944, or Placebo. The registry lists allocation as randomized. The purpose of this clinical study is to learn about the effects and safety of berobenatide (PF-08653944).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 954 people at 80 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.525Z"},{"nctId":"NCT07595770","title":"Adebrelimab Combined With Neoadjuvant Chemoradiotherapy for Esophageal Squamous Cell Carcinoma","officialTitle":"A Study on the Safety and Efficacy of Adalimumab Combined With Chemoradiotherapy as Neoadjuvant Therapy for Esophageal Squamous Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","sponsorClass":"OTHER","summary":"This study aims to systematically evaluate the safety and efficacy of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.","conditions":["Esophageal Squamous Cell Carcinoma (ESCC)"],"keywords":["chemotherapy","radiotherapy","immune checkpoint inhibitors","adebrelimab"],"interventions":[{"type":"DRUG","name":"• Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy"}],"enrollment":37,"startDate":"2026-05-22","completionDate":"2028-01-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \\- 1. Provided informed consent and sign the informed consent form;\n* 2\\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);\n* 3\\. Pathological confirmed ESCC;\n* 4\\. Patients assessed by thoracic oncologists as resectable without distant metastasis\n* 5\\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;\n* 6\\. Have at least one assessable lesion according to the RECIST V1.1\n* 7\\. ECOG-PS score: 0-1;\n* 8\\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;\n* 9\\. With a life expectancy of ≥ 6 weeks;\n* 10\\. Adequate major organ function without severe hematologic, cardiac, pulmonary, hepatic, renal, or bone marrow dysfunction, and no immunodeficiency disease;\n\nExclusion Criteria:\n\n* 1\\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy\n* 2\\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons\n* 3\\. Simultaneously developing tumors in other parts of the body\n* 4\\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)\n* 5\\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\\>10 mg/day or oral prednisone for more than 2 weeks\n* 6\\. Severe allergy to immune preparations\n* 7\\. Abnormal coagulation function: (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy\n* 8\\. Pregnancy or lactation period\n* 9\\. Other situations as judged by investigators not suitable for inclusion.;","locations":[{"facility":"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Baisheng Chen, M.D, PhD","phone":"+86-13560471611","email":"Pason06213367@163.com"}],"primaryOutcomes":["Pathological complete response (pCR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: testing • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy for Esophageal Squamous Cell Carcinoma (ESCC)","inPlainEnglish":"This study aims to systematically measure the safety and how well it works of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.","whoItsFor":["Ages 18 Years to 75 Years","3\\. Pathological confirmed ESCC;","4\\. Patients assessed by thoracic oncologists as resectable without distant metastasis","5\\. Patients evaluate with clinical staging of T1-4aN1-3M0 or T3-4aN0M0(AJCC 9.0) based on imaging and pathological examination results;","6\\. Have at least one assessable lesion according to the RECIST V1.1","7\\. ECOG-PS score: 0-1;","8\\. Patients with normal function of organs such as heart, brain, lungs, and kidneys who can tolerate surgery;","9\\. With a life expectancy of ≥ 6 weeks;"],"whoShouldSkip":["1\\. Patients who have received or are currently receiving chemotherapy, radiotherapy, immunotherapy, or targeted therapy","2\\. Patients with distant metastasis or inability to undergo resection after evaluation by thoracic surgeons","3\\. Simultaneously developing tumors in other parts of the body","4\\. Severe impairment of heart, liver, and kidney function (heart function grade 3-4, ALT and/or AST exceeding the upper limit of normal by more than 1.5 times, Cr (serum creatinine) exceeding the upper limit of normal by more than 1.5 times)","5\\. Patients with a history of autoimmune diseases who were receiving immunosuppressive therapy prior to enrollment, with immunosuppressive doses\\>10 mg/day or oral prednisone for more than 2 weeks","6\\. Severe allergy to immune preparations","7\\. Abnormal coagulation function: (PT\\>16s, APTT\\>53s, TT\\>21s, Fib\\<1.5 g/L), bleeding tendency or during thrombolytic or anticoagulant therapy"],"whatHappens":"If you join, the listed intervention(s) are • Adebrelimab and nab-paclitaxel, carboplatin in Combination With radiotherapy. The registry lists allocation as na. This study aims to systematically measure the safety and how well it works of adalimumab combined with paclitaxel, carboplatin, and short-course radiotherapy in the neoadjuvant treatment of esophageal squamous cell carcinoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 37 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.272Z"},{"nctId":"NCT07597902","title":"SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction","officialTitle":"SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction (SHIELD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a placebo (this does not contain the medications).","conditions":["Post-acute Sequelae of COVID-19","Long COVID"],"keywords":[],"interventions":[{"type":"DRUG","name":"Valacyclovir"},{"type":"DRUG","name":"Celecoxib"},{"type":"DRUG","name":"Paxlovid"},{"type":"DRUG","name":"Placebo"}],"enrollment":150,"startDate":"2026-10-20","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18-65 years of age at the time of study entry\n* Diagnosed with Long COVID\n* Individuals of child-bearing potential must have a negative serum pregnancy test at screening and agree to on-site urine pregnancy testing at all subsequent study visits\n* A urine drug screen performed at the Screening Visit must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), and non-disclosed amphetamines and opioids/opiates.\n* Those with mild to moderate depression should be clinically stable for three months, without risk of suicidal ideation or behavior.\n\nExclusion Criteria:\n\n* Breastfeeding, pregnant, or planning to become pregnant during the next six months.\n* In the opinion of the Investigator, any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the individual's ability to participate in the study or potentially compromise their well-being while enrolled in the study.\n* In the opinion of the Investigator or based on results of the HADS, evidence of a clinically significant psychiatric disorder, e.g., severe, unstable or poorly controlled depression, anxiety or obsessive-compulsive disorder; moderate or severe alcohol use disorder; substance use disorder other than mild cannabis use disorder; or any history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder.\n* Currently meeting criteria for ME/CFS at the pre-screening or screening visit, or a prior confirmed diagnosis of ME/CFS within the last 5 years. This may be determined as part of the initial screening call or visit.\n* Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the participant's ability to comply with the protocol.\n* Symptomatic and/or otherwise clinically significant cardiac disease\n* Acute non-COVID systemic infection (e.g., HIV, hepatitis) or other active viral or bacterial infection during the screening/washout period or at the Baseline visit.\n* Currently receiving chronic systemic corticosteroids (\\>5 mg prednisone daily, or equivalent)\n* Routine treatment with warfarin, heparin, lithium, digoxin, amiodarone, isoniazid, phenytoin, fluconazole, methotrexate, probenecid, or raloxifene. Participants on these medications should not be screened.\n* Uncontrolled sleep apnea.\n* Use of chronic nucleoside analog antiviral suppression therapy within one month of the Screening Visit or requiring on average more than one acute treatment course every two months.\n* Current use of celecoxib either alone or in combination with valacyclovir or famciclovir\n* In the opinion of the Investigator, evidence of current drug or alcohol abuse or dependency, or history of abuse or dependence during the preceding 12 months.\n* The participant has undergone a malabsorptive weight loss procedure (e.g., Roux-en-Y or other bypass procedure).\n* Severe IBS-C or colonic inertia as evidenced by seven or more days between bowel movements.","locations":[{"facility":"The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David Putrino, PhD","phone":"212-241-7658","email":"CoreResearch@mountsinai.org"}],"primaryOutcomes":["EQ-5D-5L Visual Analogue Scale (VAS)"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Valacyclovir for Post-acute Sequelae of COVID-19","inPlainEnglish":"The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a dummy treatment (placebo) (this does not contain the medications).","whoItsFor":["Ages 18 Years to 65 Years","18-65 years of age at the time of study entry","Diagnosed with Long COVID","Individuals of child-bearing potential must have a negative serum pregnancy test at screening and agree to on-site urine pregnancy testing at all subsequent study visits","A urine drug screen performed at the Screening Visit must be negative for drugs of abuse such as methamphetamine, cocaine, phencyclidine (PCP), and non-disclosed amphetamines and opioids/opiates","Those with mild to moderate depression should be clinically stable for three months, without risk of suicidal ideation or behavior"],"whoShouldSkip":["Breastfeeding, pregnant, or planning to become pregnant during the next six months","In the opinion of the Investigator, any clinically significant, uncontrolled, or unstable medical or surgical condition that could affect the individual's ability to participate in the study or potentially compromise their well-being while enrolled in the study","Currently meeting criteria for ME/CFS at the pre-screening or screening visit, or a prior confirmed diagnosis of ME/CFS within the last 5 years. This may be determined as part of the initial screening call or visit","Any anticipated need for surgery that in the opinion of the Principal Investigator or Sub-I might confound results or interfere with the participant's ability to comply with the protocol","Symptomatic and/or otherwise clinically significant cardiac disease","Acute non-COVID systemic infection (e.g., HIV, hepatitis) or other active viral or bacterial infection during the screening/washout period or at the Baseline visit","Currently receiving chronic systemic corticosteroids (\\>5 mg prednisone daily, or equivalent)"],"whatHappens":"If you join, the listed intervention(s) are Valacyclovir, Celecoxib, or Paxlovid. The registry lists allocation as randomized. The purpose of this research study is to test if the combination of three drugs, valacyclovir, celecoxib, and Paxlovid will decrease the symptoms of Long COVID in adults compared to a dummy treatment (placebo) (this does not contain the medications).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.231Z"},{"nctId":"NCT07598370","title":"A Study of LY3439539 in Participants With Alzheimer's Disease","officialTitle":"A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.\n\nParticipation in the study will last approximately 9 months with visits about once a month.","conditions":["Alzheimer Disease"],"keywords":["Cognitive Impairment","Neurodegenerative Diseases","Dementia"],"interventions":[{"type":"DRUG","name":"LY3439539"}],"enrollment":30,"startDate":"2026-05-21","completionDate":"2027-08","sex":"ALL","minAge":"50 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease\n* Have a Mini Mental Score Examination score of 16 to 24, inclusive\n* Meet plasma pTau criteria, as defined by the sponsor\n* Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening\n* Are women not of childbearing potential and men willing to practice effective contraception throughout the study.\n* Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.\n* Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).\n\nExclusion Criteria:\n\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.\n* Have a screening MRI that shows evidence of significant abnormality.\n* Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.\n* Have a history of\n\n  * Severe or ongoing allergy or hypersensitivity reactions\n  * Hypersensitivity to immunizations or immunoglobulins\n  * Two or more clinically significant or severe drug allergies,\n  * Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions\n* Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions\n* Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.\n* Have criteria that would preclude a lumbar puncture (LP).\n* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.\n* Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.","locations":[{"facility":"Irvine Clinical Research","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthy Brain Clinic","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inglewood Clinical","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oakland Clinical","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - The Villages","city":"Lady Lake","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AdventHealth Orlando","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"QUEST Research Institute","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flinders Medical Centre","city":"Adelaide","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Austin Health - Heidelberg Repatriation Hospital","city":"Ivanhoe","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Neurology","city":"Kogarah","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University Hospital","city":"Macquarie University","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Alfred","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Christchurch Neurology Trials","city":"Christchurch","state":"","country":"New Zealand","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lilly Centre for Clinical Pharmacology","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["irvine-california","long-beach-california","los-angeles-california","oakland-california","lady-lake-florida","maitland-florida","orlando-florida","farmington-hills-michigan","adelaide-australia","ivanhoe-australia","kogarah-australia","macquarie-university-australia","melbourne-australia","christchurch-new-zealand","singapore-singapore"],"enrichment":{"headline":"Phase 1: testing LY3439539 for Alzheimer Disease","inPlainEnglish":"This study wants to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease. Participation in the study will last approximately 9 months with visits about once a month.","whoItsFor":["Ages 50 Years to 85 Years","Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease","Have a Mini Mental Score Examination score of 16 to 24, inclusive","Meet plasma pTau criteria, as defined by the sponsor","Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening","Are women not of childbearing potential and men willing to practice effective contraception throughout the study","Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures","Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week)"],"whoShouldSkip":["Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker","Have a screening MRI that shows evidence of significant abnormality","Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality","Severe or ongoing allergy or hypersensitivity reactions","Hypersensitivity to immunizations or immunoglobulins","Two or more clinically significant or severe drug allergies,","Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions"],"whatHappens":"If you join, the listed intervention(s) are LY3439539. The registry lists allocation as na. This study wants to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.332Z"},{"nctId":"NCT07599176","title":"Partial Stem Cell Transplant for Sickle Cell Disease From Matched Donors","officialTitle":"Matched Related Donor Non-myeloablative Hematopoietic Cell Transplantation With Alemtuzumab, 400 cGy TBI, and Abatacept for Sickle Cell Disease and Beta-Thalassemia","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Heart, Lung, and Blood Institute (NHLBI)","sponsorClass":"NIH","summary":"This is a non-ablative (partial) stem cell transplant for patients with severe sickle cell disease or beta-thalassemia requiring red cell transfusions. The intensity of the transplant is slightly increased from our previous transplant regimens. The goal is to aim for higher percentage of donor cells to stably remain in the recipients long term.","conditions":["Sickle Cell Disease","Beta-thalassemia"],"keywords":["Sickle Cell Disease","Beta-Thalassemia","Stem Cell Transplant","Chimerism"],"interventions":[{"type":"RADIATION","name":"Total Body Irradiation"},{"type":"DRUG","name":"Alemtuzumab"},{"type":"DRUG","name":"Abatacept"},{"type":"OTHER","name":"Research blood draw"}],"enrollment":90,"startDate":"2026-07-08","completionDate":"2032-06-30","sex":"ALL","minAge":"4 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA\n\nRECIPIENT:\n\nParticipants must fulfill one disease category (1 or 2) and 3\n\n1. Patients with sickle cell disease at high risk for disease related morbidity or mortality, defined by having an end-organ damage (A, B, C, D, OR E) or complication(s) not ameliorated by sickle cell-specific therapies (F):\n\n   A. Stroke defined as a clinically significant neurologic event that is accompanied by an infarct on cerebral MRI ORb\n\n   B. Abnormal trans-cranial Doppler examination (\\>=200 cm/s); OR\n\n   C. Silent cerebral infarct defined as an infarct-like lesion based on an MRI signal abnormality at least 3 mm in one dimension and visible in two planes on FLAIR or T2- weighted images (or similar image with 3D imaging) and documented neurological examination performed by a neurologist demonstrating the participant has a normal neurologic examination, or an abnormality on examination that could not be explained by the location of the brain lesion(s); OR\n\n   D. Sickle cell related renal insufficiency defined by a creatinine level \\>=1.5 times the upper limit of normal and kidney biopsy consistent with sickle cell nephropathy OR nephrotic syndrome OR creatinine clearance \\<60mL/min/1.73m2 for patients \\<16 years of age or \\<50mL/min for patients \\>16 years of age OR requiring peritoneal or hemodialysis; OR\n\n   Age (Years): \\<= 5 / Upper limit of normal serum creatinine (mg/dl): 0.8\n\n   Age (Years): 5 \\< age \\<= 10 / Upper limit of normal serum creatinine (mg/dl): 1.0\n\n   Age (Years): 10 \\< age \\<= 15 / Upper limit of normal serum creatinine (mg/dl): 1.2\n\n   Age (Years): \\> 15 / Upper limit of normal serum creatinine (mg/dl): 1.3\n\n   E. Tricuspid regurgitant jet velocity (TRV) of \\>=2.5 m/s in patients at least 3 weeks after a vaso-occlusive crisis; OR\n\n   F. Recurrent severe priapism defined as at least two episodes of an erection lasting \\>=4 hours requiring medical intervention (e.g. aspiration, injection of vasoconstrictor, prior penile surgery.); OR\n\n   G. Sickle hepatopathy defined as EITHER ferritin \\>1000mcg/L OR direct bilirubin \\>0.4 mg/dL at baseline; OR\n\n   H. Vaso-occlusive crises: more than 1 hospital admission per year while on a therapeutic dose of sickle cell treatment /medication; OR\n\n   I. Acute chest syndrome (ACS): any ACS while on sickle cell treatment /medication\n2. Patients with beta-thalassemia who have grade 2 or 3 iron overload, determined by the presence of 2 or more of the following:\n\n   * Portal fibrosis by liver biopsy\n   * Inadequate chelation history (defined as failure to maintain adequate compliance with chelation with deferoxamine initiated within 18 months of the first transfusion and administered at least 5 days each week)\n   * Hepatomegaly of greater than 2 cm below the costochondral margin or by other imaging scans\n3. Non disease specific\n\n   * Ages \\>=4 years and less than 65 years old\n   * Fully matched human leukocyte antigen (HLA) donors at A, B, C, and DR loci (8 of 8 or 10 of 10)\n   * Ability to comprehend and willing to sign an informed consent, assent obtained from minors when applicable. Negative serum or urine beta-HCG, when applicable\n   * Agree to use birth control throughout the study and 3 months after abatacept or sirolimus administration.\n\n     * Female subjects must agree to use a medically acceptable method of birth control such as oral contraceptive, intrauterine device, barrier and spermicide, or implant/injection from start of screening until immunosuppression is stopped.\n     * Male subjects must agree to use effective contraception (including condoms) from start of screening until immunosuppression is stopped.\n\nDONOR:\n\n* Fully matched human leukocyte antigen (HLA) donors at A, B, C, and DR loci (8 of 8 or 10 of 10) are intended for this study.\n* Donors age 4 or older and \\>=15 kg (or weight deemed acceptable by IR for line placement, DTM for apheresis, and pediatric consult service) eligible to donate hematopoietic stem cells, are eligible for this study.\n* Donors will be evaluated in accordance with existing Standard NIH Policies and Procedures for determination of eligibility and suitability for clinical donation. Donors will sign on a separate protocol, 20-H-0099 NHLBI standard of care protocol for the mobilization and collection of HSCs. Note that participation in this study is offered to all eligible donors, but is not required for a donor to make a stem cell donation, so it is possible that not all donors will enroll onto this study.\n\nEXCLUSION CRITERIA\n\nRECIPIENT:\n\n* Karnofsky or Lanksy performance status of \\<40\n* Diffusing capacity of carbon monoxide \\<35% predicted: DLCO corrected for hemoglobin or KCO (corrected for lung volume). This criterion may be omitted in young children (e.g. near age 5) or other individuals who may have difficulty understanding or complying with instructions of testing.\n* Baseline oxygen saturation of \\<85% or PaO2 \\<70\n* Left ventricular ejection fraction: \\<35% estimated by ECHO\n* Transaminases \\>5x upper limit of normal for age\n* Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to starting the conditioning regimen\n* Major anticipated illness or organ failure incompatible with survival from HCT\n* Pregnant or breastfeeding\n\nDONOR:\n\n* Pregnant or breastfeeding\n* Cognitively impaired subjects","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kelly S Norris, R.N.","phone":"(301) 529-7104","email":"kelly.norris@nih.gov"},{"name":"John F Tisdale, M.D.","phone":"(301) 402-6497","email":"johntis@mail.nih.gov"}],"primaryOutcomes":["Donor myeloid chimerism"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Alemtuzumab for Sickle Cell Disease","inPlainEnglish":"This is a non-ablative (partial) stem cell transplant for patients with severe sickle cell disease or beta-thalassemia requiring red cell transfusions. The intensity of the transplant is slightly increased from our previous transplant regimens.","whoItsFor":["Ages 4 Years to 65 Years","Participants must fulfill one disease category (1 or 2) and 3","Patients with sickle cell disease at high risk for disease related morbidity or mortality, defined by having an end-organ damage (A, B, C, D, OR E) or complication(s) not ameliorated by sickle cell-specific therapies (F):","A. Stroke defined as a clinically significant neurologic event that is accompanied by an infarct on cerebral MRI ORb","B. Abnormal trans-cranial Doppler examination (\\>=200 cm/s); OR","Age (Years): \\<= 5 / Upper limit of normal serum creatinine (mg/dl): 0.8","Age (Years): 5 \\< age \\<= 10 / Upper limit of normal serum creatinine (mg/dl): 1.0","Age (Years): 10 \\< age \\<= 15 / Upper limit of normal serum creatinine (mg/dl): 1.2"],"whoShouldSkip":["Karnofsky or Lanksy performance status of \\<40","Baseline oxygen saturation of \\<85% or PaO2 \\<70","Left ventricular ejection fraction: \\<35% estimated by ECHO","Transaminases \\>5x upper limit of normal for age","Evidence of uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms) within one month prior to starting the conditioning regimen","Major anticipated illness or organ failure incompatible with survival from HCT","Pregnant or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Total Body Irradiation, Alemtuzumab, or Abatacept. The registry lists allocation as randomized. This is a non-ablative (partial) stem cell transplant for patients with severe sickle cell disease or beta-thalassemia requiring red cell transfusions.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at Bethesda. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.844Z"},{"nctId":"NCT07599774","title":"Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments","officialTitle":"Optimal Targeted High-definition tDCS for Reducing Post-stroke Upper Limb Motor Impairments","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Carle Foundation Hospital","sponsorClass":"OTHER","summary":"Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation. Stimulating the brain can improve its function and help with recovery after a stroke. It has been a challenge to do this non-invasively. This is because the brain is reshaped after a stroke, and thus, it is difficult to find the right places to stimulate from the outside. In previous research, investigators found that optimal type and target of tDCS varied among subjects. The goal of this pilot trial is to test the feasibility of combining individually optimized, targeted high-definition tDCS (THD-tDCS) with rehabilitation therapy. Investigators will include 16 chronic stroke subjects with their optimal stimulation setup, obtained from their previous research. The participants will be computer-randomized into two equal-sized groups to receive either optimal THD-tDCS or sham stimulation, together with rehabilitation therapy (modified constraint-induced movement therapy, mCIMT) for five sessions over two weeks. Outcome measures will be collected at the baseline and right after the final intervention session. The primary outcome measure will be the change in the FM-UE score from baseline to immediately post the final intervention to assess the immediate effect of the intervention on upper extremity motor impairment. The secondary outcome measure will be the Wolf Motor Function Test time score to evaluate the immediate effect on functional motor performance.","conditions":["Hemiparetic Stroke"],"keywords":["Upper limb","Stroke rehabilitation","Individualized intervention","High-definition transcranial direct current stimulation"],"interventions":[{"type":"DEVICE","name":"High-definition transcranial direct stimulation: sham"},{"type":"DEVICE","name":"High-definition transcranial direct stimulation: optimal"},{"type":"BEHAVIORAL","name":"Modified constraint-induced movement therapy"}],"enrollment":16,"startDate":"2026-11-09","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be 18 years or older\n* Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary.\n* Must have substantial motor impairment of the paretic upper limb\n* Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb\n* Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)\n* Fugl-Meyer Upper Extremity Score of 8-50 based on assessment performed during the baseline visit.\n* Must have had either MRI or CT of the brain performed at Carle as part of their stroke care. Imaging may have been performed either during the diagnostic work-up for stroke or as follow-up after diagnosis. The most recent images from either MRI or CT will be collected for this study.\n* Capacity to provide informed consent and participate in English (Since this study is a clinical trial and the team is yet to provide the translation service at this stage, the study is restricted to those who can consent and participate in English only).\n* Must be willing and able to perform study procedures\n\nExclusion Criteria:\n\n* Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire\n* Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device\n* Has metal implants in the head and/or brain\n* Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb\n* Presence of severe muscle wasting or contracture or significant sensory deficits in the paretic upper limb\n* Currently pregnant or planning to become pregnant during the study period\n* History of epilepsy, febrile convulsion, recurrent fainting spells or unexplained recurring headaches\n* Current use of illicit/recreational drugs\n* Currently undergoing anti-malarial treatment. (Note: participants can be considered for study participation after ant-malarial treatment has been discontinued)\n* Has known adverse reaction to TMS or tDCS","locations":[{"facility":"Carle Foundation Hospital","city":"Urbana","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yuan Yang, PhD, MS","phone":"217-244-5870","email":"yuan.yang@carle.com"},{"name":"Sanjiv Jain, MD","phone":"217-383-3800","email":"sanjiv.jain@carle.com"}],"primaryOutcomes":["Change in the Fugl-Meyer Upper Extremity score from baseline"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["urbana-illinois"],"enrichment":{"headline":"Not a traditional drug phase: High-definition transcranial direct stimulation: sham for Hemiparetic Stroke","inPlainEnglish":"Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades. Among these, non-invasive brain stimulation such as transcranial direct current stimulation (tDCS) promotes neuroplasticity in injured brains, with fewer side effects and risks than invasive, implanted approaches such as deep-brain stimulation.","whoItsFor":["Ages 18 Years to any","Must be 18 years or older","Must have had a stroke that resulted in paresis confined to one side. The use of a wheelchair or other assisting devices are not exclusionary","Must have substantial motor impairment of the paretic upper limb","Absence of severe wasting or contracture or significant sensory deficits in the paretic upper limb","Absence of severe concurrent medical problems (e.g. cardiorespiratory impairment)","Fugl-Meyer Upper Extremity Score of 8-50 based on assessment performed during the baseline visit","Must be willing and able to perform study procedures"],"whoShouldSkip":["Self-reported sensitive skin or adhesive allergy as assessed by the tDCS Safety Screening Questionnaire","Has a cardiac pacemaker, defibrillator or an implantable cardiac resynchronization therapy device","Has metal implants in the head and/or brain","Presence of muscle tone abnormalities and motor or sensory impairment in the non-paretic limb","Presence of severe muscle wasting or contracture or significant sensory deficits in the paretic upper limb","Currently pregnant or planning to become pregnant during the study period","History of epilepsy, febrile convulsion, recurrent fainting spells or unexplained recurring headaches"],"whatHappens":"If you join, the listed intervention(s) are High-definition transcranial direct stimulation: sham, High-definition transcranial direct stimulation: optimal, or Modified constraint-induced movement therapy. The registry lists allocation as randomized. Non-invasive, non-pharmaceutical technologies that augment routine clinical practice for brain diseases and manage chronic symptoms have advanced rapidly over the past two decades.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 16 people at Urbana. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.210Z"},{"nctId":"NCT07601425","title":"Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)","officialTitle":"A Randomized, Placebo-Controlled, Double-Blind, Proof-of-Concept Study of ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Atavistik Bio, Inc","sponsorClass":"INDUSTRY","summary":"This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomized, double-blind, placebo-controlled study evaluating 3 dosing regimens of ATV-1601. Patients completing Part 1 may participate in the Part 2 open-label extension to receive ATV-1601.","conditions":["Hereditary Hemorrhagic Telangiectasia (HHT)","Osler Weber Rendu Disease"],"keywords":["Arteriovenous malformations","ATV-1601","HarmonyHHT","Harmony-HHT","HarmonyHHTStudy","Vascular Diseases","Bleeding disorders","Hematologic disorders","Disorders","Telangiectasias","Hereditary hemorrhagic","Hemorrhagic disorders","Cardiovascular diseases","Vascular malformations","HHT"],"interventions":[{"type":"DRUG","name":"ATV-1601"},{"type":"DRUG","name":"Placebo"}],"enrollment":100,"startDate":"2026-07-27","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Ability to provide informed consent prior to any study-specific procedures\n* Confirmed diagnosis of hereditary hemorrhagic telangiectasia (HHT) based on Curaçao criteria\n* Moderate to severe HHT with an ESS ≥ 4\n* Anemia at Screening and/or requirement for at least 1 red-cell unit (RUE) in the previous 6 months\n* Adequate hematologic, renal, and hepatic function per protocol-defined laboratory criteria\n* Use highly effective contraception during the study and for a protocol-defined period after last dose\n\nExclusion Criteria:\n\n* Clinically significant abnormalities of glucose metabolism including diagnosed Type 1 or uncontrolled Type 2 diabetes\n* Chronic cardiac disease, or cardiac rhythm abnormalities\n* History of significant cardiovascular, hepatic, renal, or hematologic disease not related to HHT that may confound study results\n* Use of prohibited concomitant medications within a protocol-defined washout period prior to first dose (including strong CYP modulators and certain herbal supplements)\n* Recent (within 6 weeks) major surgery or local ablative procedures, or procedures on nasal telangiectasias\n* Prior AKT inhibitor\n* Pregnant or breastfeeding women\n\nAdditional Criteria for Open-Label Extension:\n\n* Participants must complete the double-blind treatment period (Part 1)","locations":[{"facility":"Arizona Pulmonary Specialists","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Diego","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Augusta University Medical Center","city":"Augusta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovative Hematology","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Utah Health Sciences Center","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Part 1: Safety and tolerability","Part 2: Safety and tolerability"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona","san-diego-california","augusta-georgia","indianapolis-indiana","boston-massachusetts","rochester-minnesota","st-louis-missouri","chapel-hill-north-carolina","salt-lake-city-utah","buenos-aires-argentina"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ATV-1601 for Hereditary Hemorrhagic Telangiectasia (HHT)","inPlainEnglish":"This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT. Part 1 is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study evaluating 3 dosing regimens of ATV-1601.","whoItsFor":["Ages 18 Years to any","Confirmed diagnosis of hereditary hemorrhagic telangiectasia (HHT) based on Curaçao criteria","Moderate to severe HHT with an ESS ≥ 4","Anemia at Screening and/or requirement for at least 1 red-cell unit (RUE) in the previous 6 months","Adequate hematologic, renal, and hepatic function per protocol-defined laboratory criteria","Use highly effective contraception during the study and for a protocol-defined period after last dose"],"whoShouldSkip":["Clinically significant abnormalities of glucose metabolism including diagnosed Type 1 or uncontrolled Type 2 diabetes","Chronic cardiac disease, or cardiac rhythm abnormalities","History of significant cardiovascular, hepatic, renal, or hematologic disease not related to HHT that may confound study results","Use of prohibited concomitant medications within a protocol-defined washout period prior to first dose (including strong CYP modulators and certain herbal supplements)","Recent (within 6 weeks) major surgery or local ablative procedures, or procedures on nasal telangiectasias","Prior AKT inhibitor","Pregnant or breastfeeding women"],"whatHappens":"If you join, the listed intervention(s) are ATV-1601, or Placebo. The registry lists allocation as randomized. This is a 2-part study evaluating ATV-1601 in participants with moderate to severe HHT.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 100 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:35.064Z"},{"nctId":"NCT07602036","title":"Type 2 Diabetes and Pregnancy a Single-arm Interventional Study","officialTitle":"Type 2 Diabetes and Pregnancy a Single-arm Interventional Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments. The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg/dL). Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.","conditions":["Pregnancy","Type 2 Diabetes"],"keywords":["type 2 diabetes","pregnancy","insulin pump","Automated insulin delivery system"],"interventions":[{"type":"DEVICE","name":"Automated insulin delivery system - Medtronic 780G"}],"enrollment":20,"startDate":"2026-05-08","completionDate":"2028-10","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Women with diagnosed pregestational type 2 diabetes or HbA1c \\>6.5% in the 1st trimester (ADA, PTD)\n2. Age 18-45 years\n3. Gestational age of 16 weeks +0 days or less at baseline\n4. Singleton pregnancy\n5. HbA1c at baseline 5.0-10%\n6. A viable pregnancy at the recruitment\n7. Willingness to continue the treatment until delivery in the clinic\n\nExclusion Criteria:\n\n1. Other types of diabetes including T1D and Monogenic diabetes\n2. Major fetal congenital defects\n3. Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial\n4. Pump therapy before pregnancy","locations":[{"facility":"Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences","city":"Poznan","state":"Wielkopolska","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ewa Wender-Ozegowska, Prof. MD PhD","phone":"+48 (61) 841-93-02","email":"ewozegow@ump.edu.pl"}],"primaryOutcomes":["Time in range","Mean sensor glycemia"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: Automated insulin delivery system - Medtronic 780G for Pregnancy","inPlainEnglish":"This single-arm treatment study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Women with diagnosed pregestational type 2 diabetes or HbA1c \\>6.5% in the 1st trimester (ADA, PTD)","Gestational age of 16 weeks +0 days or less at baseline","Singleton pregnancy","HbA1c at baseline 5.0-10%","A viable pregnancy at the recruitment","Willingness to continue the treatment until delivery in the clinic"],"whoShouldSkip":["Other types of diabetes including T1D and Monogenic diabetes","Major fetal congenital defects","Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial","Pump therapy before pregnancy"],"whatHappens":"If you join, the listed intervention(s) are Automated insulin delivery system - Medtronic 780G. The registry lists allocation as na. This single-arm treatment study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Poznan. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.515Z"},{"nctId":"NCT07602166","title":"Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans","officialTitle":"Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Vanderbilt University Medical Center","sponsorClass":"OTHER","summary":"Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+).\n\nThis trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks.\n\nThis phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.","conditions":["Salt Sensitivity of Blood Pressure","High Blood Pressure","Inflammation","Renin-Angiotensin-Aldosterone System"],"keywords":["salt sensitivity","hypertension","renin-angiotensin-aldosterone system","immune cells"],"interventions":[{"type":"DRUG","name":"2-hydroxybenzylamine"},{"type":"DRUG","name":"Placebo"}],"enrollment":20,"startDate":"2026-10-30","completionDate":"2031-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* We will perform analyses in participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion,\n* Over 18 years of age. Able to give informed consent,\n\nExclusion criteria:\n\n* Salt-resistant people,\n* Acute cardiovascular event(s) within the previous 6 months,\n* inability to understand the nature, scope, and possible consequences of the study or to participate in/comply with the protocol,\n* Current excessive alcohol or illicit drug use,\n* BP below the inclusion criteria levels after discontinuation of therapy,\n* Concomitant diabetes mellitus, type I or II,\n* Autoimmune disease,\n* Recent vaccination,\n* Younger or older than inclusion criteria,\n* Pregnant or breastfeeding\n* Women of childbearing potential unwilling to use highly effective contraceptive (see Risk section),\n* Confirmed or suspected renal, renovascular or endocrine causes of secondary hypertension,\n* Treatment with agents known to increase BP (e.g., adrenergic agonists for ADHD, SSRI and SNRI antidepressants, chronic use of decongestants or non-steroidal anti-inflammatory drugs,\n* Active or ongoing infection, including HIV/AIDS,\n* Active or ongoing malignancy with the exception of basal cell carcinoma of the skin,\n* Severe psychiatric disorders,\n* Any condition that may alter the immunological results of the study including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, giant cell arteritis, psoriasis, inflammatory bowel disease, and multiple sclerosis,\n* Use of glucocorticoids, immunosuppressants, direct immunomodulators or chemotherapeutic drugs that in the judgment of the investigators may include a major inflammatory component,\n* Individuals who have contraindications to high salt diets (e.g. heart, renal, or liver failure) or low salt diets (e.g. postural orthostatic tachycardia syndrome, prescribed salt tablets, fludrocortisone or midodrine) or 24-hr ambulatory blood pressure monitoring (e.g. women with bilateral upper extremity lymphedema following breast cancer surgeries),\n* Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT \\>1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl,\n* Use of Aspirin,\n* Use of monoamine oxidase inhibitors (MAO-I),\n* Individuals with medical contraindications to certain food content,\n* Use of nitrate therapy. (Participants who are taking PDE-5 inhibitors will be instructed to discontinue use at least 48 hours prior to testing),\n* Patients with resistant hypertension, defined as above-goal blood pressure despite the concurrent use of three antihypertensive drug classes at screening, will be excluded for safety reasons,\n* Average of three office-based blood pressure readings greater than 160 mmHg systolic or 100 mmHg diastolic will not be eligible for enrollment,\n* Use of drugs such as anticoagulants (e.g., warfarin), beta-blockers, antiarrhythmics, antidepressants/antipsychotics, and other medications primarily metabolized by CYP2C9, CYP2C19, and CYP2D6 that may cause drug-drug interaction.","locations":[{"facility":"Vanderbilt University Medical Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Annet Kirabo, D.V.M., M.Sc., Ph.D. F.A.H.A.","phone":"615-343-0933","email":"annet.kirabo@vumc.org"},{"name":"Cindy Mambungu, LPN","phone":"615-343-5828","email":"cindy.a.booker@vumc.org"}],"primaryOutcomes":["Change in 24-hour ambulatory systolic blood pressure (SBP)"],"hasResults":false,"conditionSlugs":["als","stroke","heart-failure","hypertension"],"drugSlugs":[],"locationSlugs":["nashville-tennessee"],"enrichment":{"headline":"Phase 2: testing 2-hydroxybenzylamine for Salt Sensitivity of Blood Pressure","inPlainEnglish":"Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S.","whoItsFor":["Ages 18 Years to any","We will perform analyses in participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion,"],"whoShouldSkip":["Salt-resistant people,","Acute cardiovascular event(s) within the previous 6 months,","inability to understand the nature, scope, and possible consequences of the study or to participate in/comply with the protocol,","Current excessive alcohol or illicit drug use,","BP below the who can join levels after discontinuation of therapy,","Concomitant diabetes mellitus, type I or II,","Autoimmune disease,"],"whatHappens":"If you join, the listed intervention(s) are 2-hydroxybenzylamine, or Placebo. The registry lists allocation as randomized. Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Nashville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.045Z"},{"nctId":"NCT07602582","title":"A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT).","officialTitle":"An Annual Dosing Study of Donanemab in Participants Who Completed Donanemab Study AACM","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.","conditions":["Alzheimer Disease","Dementia","Plaque, Amyloid"],"keywords":["Donanemab"],"interventions":[{"type":"DRUG","name":"Donanemab"},{"type":"DRUG","name":"Placebo"}],"enrollment":550,"startDate":"2026-05-22","completionDate":"2029-09","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have completed study AACM Addendum 7.\n* Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n* Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study.\n* Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.\n* Have any intracranial abnormality or lesion, including but not limited to macrohemorrhage, inflammation, or structural findings that, in the opinion of the investigator, may pose an unacceptable safety risk to the participant. Screening MRI finding of amyloid-related imaging abnormalities with edema (ARIA-E) may be monitored for resolution.\n* Contraindication to florbetapir F 18 PET.\n* Have had history of amyloid-targeting therapy treatment outside donanemab trials.\n* Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study.","locations":[{"facility":"Banner Alzheimer's Institute","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Huntington Beach","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irvine Clinical Research","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthy Brain Clinic","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research- Sacramento","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Syrentis Clinical Research","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Providence Medical Foundation","city":"Santa Rosa","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Infectious Disease Doctors Medical Group, APC","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VIN - Aventura","city":"Aventura","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradenton Research Center, Inc.","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research WINTER GARDEN","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Daytona Beach","city":"Daytona Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Finlay Medical Research","city":"Greenacres City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jacksonville Center for Clinical Research","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 MEDICAL Research THE VILLAGES","city":"Lady Lake","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research ORLANDO","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Merritt Island Medical Research, LLC","city":"Merritt Island","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Finlay Medical Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"VIN-Andrew Lerman","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indago Research & Health Center, Inc","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adult Medicine of Lake County, Inc.","city":"Mt. Dora","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emerald Coast Neurology - Airport Boulevard","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Progressive Medical Research","city":"Port Orange","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Tampa","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Tampa","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - The Villages","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Advanced Research & Education","city":"Gainesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Trials","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Clinical Trials - Andersonville","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - South Indianapolis","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Josephson Wallack Munshower Neurology, PC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Covenant Medical Center","city":"Waterloo","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Lake Charles (Bayou Pines)","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Center for Memory","city":"Newton","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedVadis Research Corporation","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Southfield","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Citizens Memorial Hospital District","city":"Bolivar","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vector Clinical Trials","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cognitive and Research Center of New Jersey","city":"Springfield","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NDx Clinical Research, Inc.","city":"Dayton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Lima","city":"Lima","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Senior Adults Specialty Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gadolin Research","city":"Beaumont","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universal Research Group","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo-Eki Center-building Clinic","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"P-One Clinic","city":"Hachiōji","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Center for Geriatrics and Gerontology","city":"Ōbu","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Samoncho Clinic","city":"Shinjuku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yotsuya Internal Medicine Clinic","city":"Shinjyuku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Metropolitan Institute for Geriatrics and Gerontology","city":"tabashi City","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCB Research Center","city":"Bayamón","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Change from Baseline as Measured by Clinical Dementia Rating - Sum of Boxes (CDR-SB)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["donanemab"],"locationSlugs":["phoenix-arizona","huntington-beach-california","irvine-california","long-beach-california","riverside-california","sacramento-california","san-diego-california","santa-ana-california","santa-rosa-california","walnut-creek-california","aventura-florida","bradenton-florida","clermont-florida","daytona-beach-florida","greenacres-city-florida","jacksonville-florida","lady-lake-florida","maitland-florida","merritt-island-florida","miami-florida","miami-lakes-florida","mt-dora-florida","new-port-richey-florida","orlando-florida","pensacola-florida","port-orange-florida","tampa-florida","the-villages-florida","winter-park-florida","gainesville-georgia","woodstock-georgia","boise-idaho","chicago-illinois","indianapolis-indiana","waterloo-iowa","lake-charles-louisiana","newton-massachusetts","waltham-massachusetts","southfield-michigan","bolivar-missouri","las-vegas-nevada","springfield-new-jersey","monroe-north-carolina","dayton-ohio","lima-ohio","austin-texas","beaumont-texas","houston-texas","shavano-park-texas","bellevue-washington","tacoma-washington","ch-ku-japan","hachi-ji-japan","bu-japan","shinjuku-japan","shinjyuku-japan","tabashi-city-japan","bayam-n-puerto-rico"],"enrichment":{"headline":"Phase 3: testing Donanemab for Alzheimer Disease","inPlainEnglish":"The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses. For each participant, the study will last up to 2.5 years and will include 6 visits.","whoItsFor":["Ages 55 Years to any","Have completed study AACM Addendum 7","Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities","Are individuals assigned female at birth who are not of childbearing potential, or are individuals assigned male at birth","Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies"],"whoShouldSkip":["Current serious or unstable illnesses that, in the investigator's opinion, could interfere with participation in this study","Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker","Contraindication to florbetapir F 18 PET","Have had history of amyloid-targeting therapy treatment outside donanemab trials","Have participated, within the last 30 days, in a clinical trial involving a study intervention judged not to be scientifically or medically compatible with this study"],"whatHappens":"If you join, the listed intervention(s) are Donanemab, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to determine if participants who previously took donanemab get clinical benefit when they receive annual doses.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 550 people at 62 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.496Z"},{"nctId":"NCT07604324","title":"A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Volunteers and Multiple Doses in Participants With Moderate to Severe Atopic Dermatitis","officialTitle":"A Two-part, Randomized, Participant- and Investigator-blinded, Placebo Controlled First-in-human Study to Investigate the Safety, Tolerability and Pharmacokinetics of DCY636 in a Single Ascending Dose Part in Healthy Participants and in a Multiple Dose Part in Participants With Moderate to Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this first-in-human (FIH) study is to assess the safety and tolerability, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.","conditions":["Dermatitis, Atopic"],"keywords":["Phase 1","FIH","safety and tolerability","healthy volunteers","PK","atopic dermatitis","AD","eczema"],"interventions":[{"type":"DRUG","name":"DCY636"},{"type":"DRUG","name":"Placebo"}],"enrollment":63,"startDate":"2026-06-02","completionDate":"2028-01-27","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Key Inclusion Criteria:\n\nHealthy Participants (Part 1)\n\n• Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive.\n\nParticipants with moderate to severe atopic dermatitis (Part 2)\n\n* Males and non-pregnant females age 18 years or older\n* Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals\n* Moderate to severe atopic dermatitis as defined by all of the following:\n\n  * EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit\n  * IGA score ≥3 at screening visit and baseline visit\n  * Total Body surface area (BSA) affected by AD ≥ 10 % at screening visit and baseline visit\n  * Peak Pruritus NRS score ≥4 at baseline visit, based on weekly average of daily assessment in the week prior to baseline visit\n\nKey Exclusion Criteria:\n\nAll Participants (Part 1, Part 2)\n\n* Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer.\n* Meet any of the prohibited medication use criteria at baseline visit.\n* A positive syphilis test result during screening period.\n* Evidence of active or latent TB infection, as determined by T-Spot test during screening period.\n* History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result.\n* Recent (within last half year) or ongoing helminth infection.\n* History of hepatitis B or hepatitis C or serologic evidence for viral hepatitis. A positive Hepatitis B virus surface antigen (HBsAg), Hepatitis B virus core antibody (HBcAb) and/or Hepatitis B surface antibody (HBsAb) test during screening period excludes a participant. A positive test for HBsAb can be included if the test for HBsAg and HBcAb are negative and the history of hepatitis B vaccination is known. Participants with a positive Hepatitis C virus (HCV) antibody test should be excluded.\n\nHealthy Participants (Part 1)\n\n* Women of childbearing potential\n* Smokers Participants with moderate to severe atopic dermatitis (Part 2)\n* Regular use (more than 2 visits per week) of a tanning booth/parlor or extended sun exposure (per investigator judgement) within 4 weeks prior to baseline visit\n* Have any chronic, uncontrolled medical condition, which would put the participant at increased risk during study participation, such as uncontrolled: diabetes, hypertension, morbid obesity, thyroid, adrenal, cardiovascular, pulmonary, hepatic, renal, neurologic or psychiatric disease, or other disease of concern, as per investigator judgment\n* Women of childbearing potential (WOCBP) are excluded unless they are using highly effective methods of contraception (failure rate \\< 1% per year) while taking study treatment and for 202 days (= 5 times the terminal half-life) of study treatment after stopping study treatment.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Novartis Investigative Site","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+81337978748","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Part 1-Incidence of adverse events (AEs) and serious adverse events (SAEs)","Part 2-Incidence of adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["fukuoka-japan"],"enrichment":{"headline":"Phase 1: testing DCY636 for Dermatitis, Atopic","inPlainEnglish":"The purpose of this first-in-human (FIH) study is to assess the whether it is safe and how hard side effects are to live with, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636. The results are intended to support the further clinical development of DCY636 in future studies.","whoItsFor":["Ages 18 Years to 55 Years","Healthy Participants (Part 1)","Healthy male and non-childbearing potential female participants 18 to 55 years of age inclusive","Participants with moderate to severe atopic dermatitis (Part 2)","Males and non-pregnant females age 18 years or older","Diagnosis of atopic dermatitis for at least 1 year not adequately controlled by topicals","Moderate to severe atopic dermatitis as defined by all of the following:","EASI score ≥12 at screening visit and ≥16 at baseline (BL) visit"],"whoShouldSkip":["All Participants (Part 1, Part 2)","Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer","Meet any of the prohibited medication use criteria at baseline visit","A positive syphilis test result during screening period","Evidence of active or latent TB infection, as determined by T-Spot test during screening period","History of immunodeficiency diseases, or a positive human immunodeficiency virus (HIV) test result","Recent (within last half year) or ongoing helminth infection"],"whatHappens":"If you join, the listed intervention(s) are DCY636, or Placebo. The registry lists allocation as randomized. The purpose of this first-in-human (FIH) study is to assess the whether it is safe and how hard side effects are to live with, pharmacokinetics (PK), immunogenicity (IG) and pharmacodynamics (PD) of DCY636.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 63 people at Fukuoka. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.812Z"},{"nctId":"NCT07604896","title":"Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","officialTitle":"Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"First Affiliated Hospital of Wenzhou Medical University","sponsorClass":"OTHER","summary":"This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.\n\nThe primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.","conditions":["Alzheimer s Disease","Alzheimer Dementia (AD)","MCI-AD, Early Stage Alzheimer's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lecanemab 10 mg/kg"},{"type":"DRUG","name":"Conventional anti-dementia treatment group"}],"enrollment":200,"startDate":"2026-01-01","completionDate":"2027-12-31","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age: 50 to 90 years old.\n* No gender restrictions.\n* Patients with MCI and mild AD.\n* The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.\n* Positive Amyloid protein confirmed by amyloid-PET or CSF.\n* There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.\n* Agree to participate in the research and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment caused by reasons other than AD.\n* There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.\n* A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.\n* Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.\n* There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.\n* There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).\n* There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.\n* Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.\n* Surgical operations under general anesthesia are planned to be performed during the research period.\n* Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.","locations":[{"facility":"First Affiliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zhen Wang, M.D.","phone":"+8613858868961","email":"wangzhen@wzhospital.cn"}],"primaryOutcomes":["Change in Aβ-PET centiloid values"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["wenzhou-china"],"enrichment":{"headline":"Phase 4: testing Lecanemab 10 mg/kg for Alzheimer s Disease","inPlainEnglish":"This research proposal outlines a multi-center, randomly assigned, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited.","whoItsFor":["Ages 50 Years to 90 Years","Age: 50 to 90 years old","No gender restrictions","Patients with MCI and mild AD","The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point","Positive Amyloid protein confirmed by amyloid-PET or CSF","There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial"],"whoShouldSkip":["Patients with cognitive impairment caused by reasons other than AD","There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening","Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study","There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment","There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans)","There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening","Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the dummy treatment (placebo) treatment group"],"whatHappens":"If you join, the listed intervention(s) are Lecanemab 10 mg/kg, or Conventional anti-dementia treatment group. The registry lists allocation as randomized. This research proposal outlines a multi-center, randomly assigned, trial.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 200 people at Wenzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.232Z"},{"nctId":"NCT07604922","title":"Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","officialTitle":"Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Institut National de la Santé Et de la Recherche Médicale, France","sponsorClass":"OTHER_GOV","summary":"This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD. The primary objective is to compare baseline small vessel pressure measured with the HEMI (Multi-spectral optical system for microcirculation hemodynamics) device across groups in order to identify microvascular alterations associated with cardiometabolic and renal disease. Secondary objectives include assessment of microvascular responses after post-ischemic hyperemia, evaluation of SPG-derived (Speckle plethysmography) small vessel flow and volume parameters, comparison with reference vascular measurements (including SphygmoCor and ultra-high frequency ultrasound), and evaluation of feasibility, acceptability, and measurement reproducibility. Participation is non-randomized, based on participants' pre-existing clinical condition, and study procedures are non-invasive with an expected visit duration of approximately 60 minutes.","conditions":["Chronic Kidney Disease","Hypertension (HTN)","Type 2 Diabetes Mellitus (T2DM)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"HEMI device"},{"type":"DEVICE","name":"SPG-NINOX device"}],"enrollment":165,"startDate":"2026-09-17","completionDate":"2028-03-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  * Adults aged over 18 years, of both sexes\n  * Patients eligible for or affiliated with a social security scheme\n  * Patients who have provided written informed consent to participate in the study\n\nCommon Exclusion Criteria:\n\n* Inability to give informed consent\n* Persons under legal protection (guardianship, trusteeship, or court protection)\n* Language barrier or psychological refusal to read the information\n* Medical conditions with a life expectancy \\< 1 year according to clinical judgment\n* Ongoing participation restriction due to another clinical research study\n* Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)\n* Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block\n\nExclusion Criteria:\n\n* Hypertension Group\n\n  * Inclusion: Prior diagnosis of arterial hypertension\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\<60 mL/min\n    * ACR \\> 30 mg/mmol\n    * Type 2 diabetes Type 2 Diabetes Group\n  * Inclusion:\n  * Prior diagnosis of type 2 diabetes\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n\n    * CKD with GFR \\< 60 mL/min\n    * ACR \\> 30 mg/mmol Moderate CKD Group\n  * Inclusion:\n  * Moderate CKD (eGFR between 30 and 60 mL/min) (CKD-EPI)\n  * Patients scheduled for arterial stiffness assessment as part of routine care\n  * Stable cardiovascular treatment in the previous 1 month\n  * Exclusion:\n  * No specific exclusion criteria beyond common exclusions Severe CKD Group\n  * Inclusion:\n\n    * Severe CKD (GFR \\< 30 mL/min for ≥ 2 months)\n    * Patients scheduled for arterial stiffness assessment as part of routine care\n    * Stable cardiovascular treatment the previous 1 month\n  * Exclusion: No specific exclusion criteria beyond common exclusions20 / 48 C25-07\\_Protocole\\_ V1.0\\_01.12.2025 Healthy Volunteers Group\n  * Inclusion: No documented chronic disease\n  * Exclusion:\n\n    * Moderate or severe CKD (GFR \\< 60 mL/min) (CKD-EPI)\n    * Hypertension\n    * Type 2 diabetes\n    * Stable cardiovascular treatment in the previous 1 month","locations":[{"facility":"INSERM U970, Equipe 7, 56 rue Leblanc","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rosa Maria BRUNO, Professor","phone":"+33 1 53 98 79 67","email":"rosa-maria.bruno@inserm.fr"}],"primaryOutcomes":["HEMI-derived small vessel pressure at baseline"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","chronic-kidney-disease","hypertension"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: HEMI device for Chronic Kidney Disease","inPlainEnglish":"This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults. The study will include 165 participants divided into five groups (33 per group): healthy volunteers, patients with hypertension without chronic kidney disease (CKD), patients with type 2 diabetes without CKD, patients with moderate CKD, and patients with severe CKD.","whoItsFor":["Ages 18 Years to any","Common who can join:","Adults aged over 18 years, of both sexes","Patients eligible for or affiliated with a social security scheme"],"whoShouldSkip":["Persons under legal protection (guardianship, trusteeship, or court protection)","Language barrier or psychological refusal to read the information","Medical conditions with a life expectancy \\< 1 year according to clinical judgment","Ongoing participation restriction due to another clinical research study","Pregnant women (due to physiological hemodynamic changes in blood pressure and arterial stiffness during pregnancy)","Cardiac arrhythmias: current atrial fibrillation or high-degree atrioventricular block"],"whatHappens":"If you join, the listed intervention(s) are HEMI device, or SPG-NINOX device. The registry lists allocation as randomized. This prospective, single-center clinical investigation conducted in France will evaluate two non-invasive investigational devices (HEMI and SPG-NINOX) designed to assess microcirculation in adults.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 165 people at Paris. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.523Z"},{"nctId":"NCT07606339","title":"A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis","officialTitle":"Real-world, International, Non-interventional Study of Guselkumab Persistence in Patients With Crohn's Disease and Ulcerative Colitis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen-Cilag Pharma GmbH","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.","conditions":["Crohn Disease","Colitis, Ulcerative"],"keywords":[],"interventions":[],"enrollment":35,"startDate":"2026-06-10","completionDate":"2029-06-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics (SmPC) of drug. Decision to prescribe must solely be made by the treating physician. Enrolment must take place before or on the day of the first administration\n* Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records\n* Must sign a participation agreement/informed consent form (ICF) allowing source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindicated to guselkumab per the label\n* Is currently enrolled in an interventional clinical study\n* Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included\n* History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)\n* Is unable to provide informed consent","locations":[{"facility":"Medical University Vienna","city":"Vienna","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Persistence with Guselkumab Treatment"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["vienna-austria"],"enrichment":{"headline":"A Study of Guselkumab in Participants With Crohn's Disease and Ulcerative Colitis","inPlainEnglish":"This study wants to evaluate how long a participant keeps taking guselkumab or continues with their treatment plan without stopping (treatment persistence) in participants with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) in real-world setting. CD and UC are inflammatory bowel diseases, a group of inflammatory conditions of the colon and small intestine.","whoItsFor":["Ages 18 Years to any","Confirmed diagnosis of moderate-to-severe UC or CD disease record in their medical records"],"whoShouldSkip":["Contraindicated to guselkumab per the label","Is currently enrolled in an treatment clinical study","Has been previously exposed to interleukin (IL)-23 inhibitors, including Tremfya (guselkumab), Skyrizi (risankizumab) and Omvoh (mirikizumab). As an exception, participants with history of Ustekinumab exposure may be included","History of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy (biologics and/or small molecules)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 35 people at Vienna. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.893Z"},{"nctId":"NCT07607678","title":"A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab","officialTitle":"A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.\n\nParticipants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.\n\nParticipants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.","conditions":["Advanced Solid Cancer","Metastatic Solid Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"BI 3819026"},{"type":"DRUG","name":"Ezabenlimab (BI 754091)"}],"enrollment":60,"startDate":"2026-05-01","completionDate":"2028-06-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria :\n\n1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.\n2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1\n3. Patients with brain metastases are eligible provided they meet the following criteria:\n\n   * Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,\n   * Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,\n   * Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.\n4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor\n5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible \\[like hypothyroidism\\], and amenorrhea/menstrual disorders which can be any grade)\n6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.\n\nExclusion Criteria :\n\n1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:\n\n   * Effectively treated non-melanoma skin cancers\n   * Effectively treated carcinoma in situ of the cervix\n   * Effectively treated ductal carcinoma in situ of the breast\n   * Other effectively treated malignancy that is considered cured by local treatment\n2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)\n3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment\n4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:\n\n   * Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)\n   * Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed\n5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)\n6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible\n7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)\n8. Patients with history of HIV infection who meet one or more of the following criteria:\n\n   * CD4+ count \\<350 cells/µL\n   * Viral load \\>400 copies/mL\n   * Not receiving antiretroviral therapy\n   * Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment\n   * History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.","locations":[{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hackensack University Medical Center","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Langone Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Chiba, Kashiwa","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Tokyo, Chuo-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clínica Universidad de Navarra","city":"Pamplona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Valencia","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-0127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","hackensack-new-jersey","new-york-new-york","nashville-tennessee","chiba-kashiwa-japan","tokyo-chuo-ku-japan","barcelona-spain","pamplona-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing BI 3819026 for Advanced Solid Cancer","inPlainEnglish":"This study is open to adults with advanced cancer. this study wants to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab.","whoItsFor":["Ages 18 Years to any","Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy","At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1","Patients with brain metastases are eligible provided they meet the following criteria:","Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,","Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,","Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment","Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor"],"whoShouldSkip":["Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:","Effectively treated non-melanoma skin cancers","Effectively treated carcinoma in situ of the cervix","Effectively treated ductal carcinoma in situ of the breast","Other effectively treated malignancy that is considered cured by local treatment","Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related side effects (AE)","Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment"],"whatHappens":"If you join, the listed intervention(s) are BI 3819026, or Ezabenlimab (BI 754091). The registry lists allocation as randomized. This study is open to adults with advanced cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.058Z"},{"nctId":"NCT07607782","title":"Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)","officialTitle":"Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Beth Israel Deaconess Medical Center","sponsorClass":"OTHER","summary":"This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.\n\nAdults aged 18-40 years who live in the United States and have not meditated regularly (defined as more than four times per week at any point in their lives) are invited to participate.\n\nParticipants will be randomly assigned to one of three groups for 4 weeks:\n\n1. Intervention group: Participants will complete a 7-minute Miracle of Mind meditation each day using a mobile app.\n2. Active comparator group: Participants will listen to a neutral 7-minute audio lesson each day.\n3. Control group: Participants will continue their usual daily routine without adding anything new.\n\nAll participants will complete brief online surveys at the start of the study and several times during the 4-week study period. Surveys will ask about mood, stress, anxiety, overall well-being, and mindfulness.\n\nParticipants who already wear a smartwatch, such as a Fitbit or Apple Watch, may choose to share heart rate and related data so that researchers can examine whether meditation may also affect physical signs of stress.\n\nInvestigators will compare changes over time among the three groups to determine whether the daily 7-minute meditation helps young adults feel better, experience less stress, and become more emotionally resilient.","conditions":["Mental Health and General Well-being"],"keywords":["Digital meditation","App-based guided meditation","Miracle of Mind meditation","Young adults mental health","Stress and anxiety reduction","Emotional well-being","Mindfulness","Randomized controlled trial","Active and passive control groups","Well-being questionnaires","Physiological stress indicator"],"interventions":[{"type":"BEHAVIORAL","name":"Miracle of Mind meditation"},{"type":"BEHAVIORAL","name":"Neutral audio learning task"}],"enrollment":354,"startDate":"2026-10-27","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals between the ages of 18-40 years\n* Currently residing in the USA\n* Individuals who are English speaking\n* Willing and able to download an application on iOS/Android\n\nExclusion Criteria:\n\n* Individuals who are non-English speaking\n* Unable to access an iOS/Android smartphone\n* Individuals who regularly practice any form of meditation \\>4 times per week\n* Individuals scoring 9-12 on the PHQ-4, or ≥3 on either the PHQ-2 or GAD-2 subscale","locations":[{"facility":"Beth Israel Deaconess Medical Centre","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Balachundhar Subramaniam, MD, MPH","phone":"617-667-2721","email":"sadhgurucenter_research@bidmc.harvard.edu"},{"name":"Sepideh Hariri, PhD","phone":"617-667-2721","email":"sadhgurucenter_research@bidmc.harvard.edu"}],"primaryOutcomes":["Well-being"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Miracle of Mind meditation for Mental Health and General Well-being","inPlainEnglish":"This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives. Adults aged 18-40 years who live in the United States and have not meditated regularly (defined as more than four times per week at any point in their lives) are invited to participate.","whoItsFor":["Ages 18 Years to 40 Years","Individuals between the ages of 18-40 years","Currently residing in the USA","Individuals who are English speaking","Willing and able to download an application on iOS/Android"],"whoShouldSkip":["Individuals who are non-English speaking","Unable to access an iOS/Android smartphone","Individuals who regularly practice any form of meditation \\>4 times per week","Individuals scoring 9-12 on the PHQ-4, or ≥3 on either the PHQ-2 or GAD-2 subscale"],"whatHappens":"If you join, the listed intervention(s) are Miracle of Mind meditation, or Neutral audio learning task. The registry lists allocation as randomized. This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 354 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.343Z"},{"nctId":"NCT07607938","title":"Psilocybin as a Novel Therapy for Residual Anhedonia","officialTitle":"Targeting Reward Circuits: Psilocybin as a Novel Therapy for Residual Anhedonia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting.\n\nThe study will test whether a single 25 mg dose of psilocybin, compared with placebo, can improve these symptoms and improve the function of brain circuits involved in reward and motivation. Researchers will measure changes using brain imaging (fMRI) and clinical questionnaires, including the Dimensional Anhedonia Rating Scale (DARS).","conditions":["Anhedonia","Emotional Blunting"],"keywords":["SSRI","SNR","Depression","Anhedonia","Emotional Blunting","Psilocybin"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Placebo"}],"enrollment":90,"startDate":"2026-09","completionDate":"2030-08-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Able to provide voluntary signed and dated informed consent.\n* Females of childbearing potential (FOCBP) must agree to practice an effective means of birth control throughout the duration of the trial\n* Males who have FOCBPs as partners must agree to practice an effective means of birth control throughout the duration of the trial\n* State willingness to comply and be available for all study requirements, including psychological, cognitive, imaging and procedural evaluations for the duration of the study\n* Meet DSM-5 criteria for major depressive disorder (MDD)\n* Screening Dimensional Anhedonia Rating Scale (DARS) total score of \\< 28.5 points\n* Have an identified support person\n* Agree to refrain from taking all non-prescription medications and supplements (nutritional and herbal) for at least 1 week prior to the IP administration session unless approved by the Investigator.\n\nExclusion Criteria:\n\n* Inability to speak and understand English sufficiently to complete informed consent and study procedures.\n* Inability to provide informed consent.\n* Women who are pregnant or who intend to become pregnant or nurse during the study duration.\n* Prior exposure to classic psychedelics (i.e., psilocybin, LSD, ayahuasca, and/or mescaline) within the past 1 year.\n* Current or previous psychiatric conditions that meet DSM-5 criteria for psychotic disorders (i.e., schizophrenia, schizoaffective disorder, MDD with psychosis), bipolar 1 or 2 disorder, or current diagnosis of active substance use disorder.\n* Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS assessment (severity score \\> 3) at the Screening visit, confirmed by the Investigator.\n* Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator.\n* Immediate family history (i.e., parents, full siblings, or half siblings) with known or suspected psychotic disorder.\n* Presence of medical conditions that may confound results of imaging study or that are contraindications to or psilocybin exposure (i.e., neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);\n* Presence of contraindications to MRI scanning (implantable devices, bone hardware, various IUD).\n* Participants who received electroconvulsive therapy (ECT), trans magnetic cranial stimulation (TMS), and/or ketamine in the past 90 days.\n* Has any other physical or psychological symptom, medication, or other relevant finding prior to randomization that, based on the clinical judgment of trial personnel, would make a participant unsuitable for the trial.\n* Are unable or unwilling to discontinue taking any protocol-prohibited medications and supplements.","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julia Diamond","phone":"646-754-4744","email":"Julia.Diamond@nyulangone.org"}],"primaryOutcomes":["Change in Dimensional Anhedonia Rating Scale (DARS) Score","Change in Fronto-Striatal Connectivity (pgACC-NAcc FC)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["psilocybin"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 1: testing Psilocybin for Anhedonia","inPlainEnglish":"This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting. The study will test whether a single 25 mg dose of psilocybin, compared with dummy treatment (placebo), can improve these symptoms and improve the function of brain circuits involved in reward and motivation.","whoItsFor":["Ages 18 Years to 65 Years","Age between 18 and 65 years","Females of childbearing potential (FOCBP) must agree to practice an effective means of birth control throughout the duration of the trial","Males who have FOCBPs as partners must agree to practice an effective means of birth control throughout the duration of the trial","State willingness to comply and be available for all study requirements, including psychological, cognitive, imaging and procedural evaluations for the duration of the study","Meet DSM-5 criteria for major depressive disorder (major depression)","Screening Dimensional Anhedonia Rating Scale (DARS) total score of \\< 28.5 points","Have an identified support person"],"whoShouldSkip":["Women who are pregnant or who intend to become pregnant or nurse during the study duration","Prior exposure to classic psychedelics (i.e., psilocybin, LSD, ayahuasca, and/or mescaline) within the past 1 year","Current or previous psychiatric conditions that meet DSM-5 criteria for psychotic disorders (i.e., schizophrenia, schizoaffective disorder, major depression with psychosis), bipolar 1 or 2 disorder, or current diagnosis of active substance use disorder","Have active suicidal ideation with intent, based on Columbia-Suicide Severity Rating Scale (C-SSRS assessment (severity score \\> 3) at the Screening visit, confirmed by the Investigator","Have made a medically significant suicide attempt (i.e., one that had a significant possibility of causing death or permanent harm in the absence of intervention) within the past 12 months, based on Screening C-SSRS assessment and confirmation by the Investigator","Immediate family history (i.e., parents, full siblings, or half siblings) with known or suspected psychotic disorder","Presence of medical conditions that may confound results of imaging study or that are contraindications to or psilocybin exposure (i.e., neurological, renal, hypertension, metabolic or cardiovascular disease or pregnancy);"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, or Placebo. The registry lists allocation as randomized. This study is for adults with major depressive disorder (depression) who are currently taking an SSRI or SNRI antidepressant but continue to experience anhedonia (reduced interest or pleasure) and emotional blunting.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.103Z"},{"nctId":"NCT07609381","title":"Clinical Information System Impact on Hospitalized Patients With Chronic Disease","officialTitle":"Evaluating the Impact of Alberta Health Services' New Provincial Clinical Information System on Patient Outcomes and Experiences With Chronic Diseases - Study Protocol for a Multi-center Interrupted Time Series Analysis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Calgary","sponsorClass":"OTHER","summary":"This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.","conditions":["Diabete Mellitus","Kidney Disease","Heart Failure","Coronary Artery Disease","Chronic Lung Diseases"],"keywords":["Clinical Information System"],"interventions":[{"type":"OTHER","name":"Clinical Information System (CIS) / Connect Care Implementation"}],"enrollment":124240,"startDate":"2026-01-01","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of hospital admission.\n* Residents of Alberta eligible to receive acute-care services in AHS facilities.\n* Hospitalized for any cause during the study period (5 years pre-implementation and 2 years post-implementation of the CIS).\n* Meet the validated case definition for one or more of the five key NCDs (diabetes mellitus, chronic kidney disease, coronary artery disease, heart failure, or chronic lung disease) based on ICD codes, laboratory measures, or pharmacy records during standardized lookback periods (up to 5 years for diagnoses; up to 1 year for labs/pharmacy).\n* Have a qualifying date for the NCD(s) that occurs prior to or during the index hospital admission.\n* Eligible for inclusion in the primary and patient experience outcomes if they survive to hospital discharge.\n* May enter multiple sub-cohorts if more than one NCD is present.\n\nExclusion Criteria:\n\n* Individuals younger than 18 years at the time of hospital admission.\n* Non-residents of Alberta or individuals not eligible for care within AHS facilities.\n* Hospitalizations that end in death (excluded from analyses of the primary outcome and patient experience measures).\n* Patients without evidence of any of the five key NCDs during the lookback period or at the index hospital admission.\n* Admissions outside the study period or admissions for which necessary administrative, laboratory, or pharmacy data are unavailable.","locations":[{"facility":"University of Calgary","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nusrat S Shommu, PhD","phone":"4032103991","email":"nsshommu@ucalgary.ca"}],"primaryOutcomes":["All-cause unplanned hospital readmission or death within 30 days after hospital discharge"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","heart-failure"],"drugSlugs":[],"locationSlugs":["calgary-canada"],"enrichment":{"headline":"Not a traditional drug phase: Clinical Information System (CIS) / Connect Care Implementation for Diabete Mellitus","inPlainEnglish":"This is a retrospective, watch-and-measure (no experimental treatment required) study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older at the time of hospital admission","Residents of Alberta eligible to receive acute-care services in AHS facilities","Hospitalized for any cause during the study period (5 years pre-implementation and 2 years post-implementation of the CIS)","Have a qualifying date for the NCD(s) that occurs prior to or during the index hospital admission","Eligible for inclusion in the primary and patient experience outcomes if they survive to hospital discharge","May enter multiple sub-cohorts if more than one NCD is present"],"whoShouldSkip":["Individuals younger than 18 years at the time of hospital admission","Non-residents of Alberta or individuals not eligible for care within AHS facilities","Hospitalizations that end in death (excluded from analyses of the primary outcome and patient experience measures)","Patients without evidence of any of the five key NCDs during the lookback period or at the index hospital admission","Admissions outside the study period or admissions for which necessary administrative, laboratory, or pharmacy data are unavailable"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 124,240 people at Calgary. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.490Z"},{"nctId":"NCT07609719","title":"A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy","officialTitle":"A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \\[IV\\], ocrelizumab IV) or PPMS (ocrelizumab IV).","conditions":["Multiple Sclerosis"],"keywords":["Primary Progressive Multiple Sclerosis","Relapsing Multiple Sclerosis"],"interventions":[{"type":"DRUG","name":"OCR SC"}],"enrollment":100,"startDate":"2026-09-02","completionDate":"2029-02-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria\n* Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)\n* Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study\n* Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy\n\nExclusion Criteria:\n\n* Participants who have demonstrated suboptimal response to aCD20 therapy\n* Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy\n* Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure\n* Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \\[HIV\\], syphilis, human papillomavirus \\[HPV\\], tuberculosis \\[TB\\])\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS\n* Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study\n* Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation\n* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation\n* Treatment with any live-attenuated vaccine within 6 weeks prior to baseline\n* Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)\n* Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone\n* Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening\n\nOther protocol defined inclusion and exclusion criteria may apply.","locations":[{"facility":"Alabama Neurology Associates","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Endpoints, LLC","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Neurology of Colorado, LLC","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Associates, PA","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Neuroscience Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Savannah Neurology Specialists,PC","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Clinic PC","city":"Cordova","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Caribbean Center for Clinical Research","city":"Guaynabo","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S.)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With no Change or Reduction From Baseline in Number of T1 Gadolinium-enhanced (Gd+) Lesions as Detected by Brain Magnetic Resonance Imaging (MRI) at Week 24"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab","ofatumumab"],"locationSlugs":["birmingham-alabama","scottsdale-arizona","fort-collins-colorado","maitland-florida","atlanta-georgia","savannah-georgia","cordova-tennessee","guaynabo-puerto-rico"],"enrichment":{"headline":"Phase 4: testing OCR SC for Multiple Sclerosis","inPlainEnglish":"This study wants to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \\[IV\\], ocrelizumab IV) or PPMS (ocrelizumab IV).","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria","Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening)","Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy"],"whoShouldSkip":["Participants who have demonstrated suboptimal response to aCD20 therapy","Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure","Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \\[HIV\\], syphilis, human papillomavirus \\[HPV\\], tuberculosis \\[TB\\])","History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)","Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS","Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study","Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation"],"whatHappens":"If you join, the listed intervention(s) are OCR SC. The registry lists allocation as na. This study wants to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \\[IV\\], ocrelizumab IV) or PPMS (ocrelizumab IV).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.980Z"},{"nctId":"NCT07609914","title":"A Study to Learn About the Safety of Taking an Additional Dose of the Medicine Rimegepant in Adults With Migraine","officialTitle":"A PHASE 4, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF REDOSING OF RIMEGEPANT IN PARTICIPANTS 18 YEARS OF AGE OR OLDER FOR THE ACUTE TREATMENT OF MIGRAINE","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.\n\nThe primary purpose of this study is to evaluate the safety and tolerability of redosing of rimegepant when taken for the acute treatment of a migraine attack, as it is possible that some patients may benefit from a second dose of rimegepant in this setting.","conditions":["Acute Treatment of Migraine"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rimegepant"}],"enrollment":400,"startDate":"2026-05-28","completionDate":"2028-06-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion:\n\n* Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition\n* Eligible participants must be currently using acute migraine treatment in accordance with the local label and have all of the following on average across the 12 weeks prior to the Screening Visit and, during the first 28 days of the observation phase (OP): (1) 6-14 monthly migraine days (MMDs); (2) \\<15 monthly headache days (MHDs) (migraine or non-migraine); and (3) \\<7 monthly non-migraine headache days.\n\nExclusion:\n\n* Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible.","locations":[{"facility":"Hope Clinical Research","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Pain Research Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Offices of South Florida","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AppleMedical Research Group, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brainstorm Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Crosse Research Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Josephson Wallack Munshower Neurology","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"New England Regional Headache Center","city":"Worcester","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Headache & Neurological Institute","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Minneapolis Clinic of Neurology - Burnsville Office","city":"Burnsville","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proven Endpoints, LLC","city":"Ridgeland","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Clinical Research Las Vegas (Excel Clinical Research)","city":"Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research - Las Vegas Rainbow","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headache Wellness Center","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Abington Neurological Associates","city":"Abington","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red Star Research, LLC","city":"Lake Jackson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medstar Health - Department of Neurology","city":"McLean","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center","city":"Ramat Gan","state":"Central District","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Incidence of Treatment-Emergent Adverse Events (TEAEs), serious TEAEs, and TEAEs leading to study intervention discontinuation on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall","Incidence of LFT elevations, AST >3x ULN, alanine aminotransferase ALT >3x ULN, and total bilirubin >2x ULN on treatment by average monthly redosing frequency over the entire OLT phase (<3, ≥3 to <6, ≥6 re-doses per month) and overall"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["canoga-park-california","fresno-california","los-angeles-california","boca-raton-florida","miami-florida","orlando-florida","chicago-illinois","indianapolis-indiana","worcester-massachusetts","ann-arbor-michigan","burnsville-minnesota","ridgeland-mississippi","las-vegas-nevada","greensboro-north-carolina","abington-pennsylvania","austin-texas","dallas-texas","lake-jackson-texas","mclean-virginia","ramat-gan-israel","jerusalem-israel","tel-aviv-israel"],"enrichment":{"headline":"Phase 4: testing Rimegepant for Acute Treatment of Migraine","inPlainEnglish":"Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack. International Headache Society (IHS) global practice recommendations for the Acute Treatment of Migraine suggest a second dose of the same medication within the recommended dose limit in people with headache relapse after successful initial treatment of a migraine attack.","whoItsFor":["Ages 18 Years to any","Eligible participants include adult participants aged 18 years of age or older with a minimum 1-year history of migraine (with or without aura) consistent with International Classification of Headache Disorders, 3rd Edition","Participants with headaches occurring ≥15 days per month (migraine or non-migraine) on average across the 12 weeks prior to the Screening Visit and ≥7 non-migraine headache days per month on average across the 12 weeks prior to the Screening Visit would not be eligible"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Rimegepant. The registry lists allocation as randomized. Acute treatments for migraine may not provide sufficient pain relief after an initial dose, and a second dose of a given medication may be needed to fully abort an attack.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 400 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.305Z"},{"nctId":"NCT07610135","title":"Psilocybin Efficacy With or Without Pimavanserin Pretreatment","officialTitle":"PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration.\n\nThe purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.","conditions":["Mood (Psychological Function)","Well Being","Mood","Healthy"],"keywords":["Psilocybin","Randomized Controlled Trial","Tryptamine","Pimavanserin","Indoles","Indole Alkaloid"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"DRUG","name":"Pimavanserin"},{"type":"DRUG","name":"Inactive Placebo"}],"enrollment":20,"startDate":"2026-10-29","completionDate":"2028-06","sex":"ALL","minAge":"21 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 21 to 65 years old\n* Provision of written informed consent\n* Fluency in English\n* At least high school level of education\n* Right-handed\n* Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report.\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the mornings of drug session days. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on session days.\n* Agree not to take any PRN medications on the mornings of drug sessions\n* Agree that for one week before the drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n* Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study.\n* Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year.\n* Condoms alone are not considered highly effective.\n* Abstinence is not considered a highly effective method. However, at the investigator's discretion, abstinence may be accepted if, based on the investigator's judgment and knowledge of the participant's usual and preferred lifestyle, it can be reasonably expected to result in 100% effectiveness.\n\nExclusion Criteria:\n\n* Non-English speakers and those with language or hearing impairments\n* Left-handedness (assessed by the Edinburgh Handedness Inventory)\n* Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)\n* History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder.\n* Current use of neuropsychiatric medications, including but not limited to typical/atypical antidepressants, antipsychotics, and stimulants.\n* Lifetime history of substance use disorder\n* Current (within past six months) substance use disorder of moderate or greater severity\n* Clinically significant suicidal ideation (with strong intent or means) within the past 6 months or lifetime history of suicide attempt, current suicidal ideation, or otherwise judged by a study clinician to be more than low risk for suicidality\n* Current use/positive toxicology for illicit drugs at screening and prior to drug administration session (includes illicit, non-prescribed, or prohibited substances such as amphetamines, barbiturates, buprenorphine, benzodiazepines, cocaine, MDMA, methadone, opioids, phencyclidine (PCP), and tetrahydrocannabinol (THC))\n* Nicotine user consuming the equivalent of ≥ 10 cigarettes/day\n* Altered gastrointestinal anatomy \\[history of surgeries that promote a general intestinal malabsorption (e.g., jejunoileal bypass, jejunocolic bypass, roux-en-Y gastric bypass, vertical banded gastroplasty, gastric band, gastric stapling, sleeve gastrectomy, biliopancreatic diversion with partial gastrectomy, distal gastric bypass, duodenal switch)\\]\n* Weight \\< 40kg\n* Have a first degree relative with schizophrenia or other psychotic disorders (except substance/medication-induced or due to another medical condition), or bipolar I disorder\n* MRI contraindications (e.g., claustrophobia incompatible with MRI scanning, medical device or implant incompatible with MRI, prior history as a metal worker and/or certain metallic objects in the body). Must complete MRI screening form and be approved by MRI technologist before each scan.\n* Unable or unwilling to perform study procedures, or inappropriate for further study participation as determined by the PI and/or study clinicians","locations":[{"facility":"Johns Hopkins Center for Psychedelic and Consciousness Research","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arozo Azimi","phone":"410-550-0007","email":"aazimi2@jh.edu"},{"name":"Mazen A. Atiq, MD","phone":"","email":"matiq3@jh.edu"}],"primaryOutcomes":["Persisting Effects Questionnaire (PEQ) score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Psilocybin for Mood (Psychological Function)","inPlainEnglish":"Twenty healthy adults (≥21 years old) will be enrolled to measure the how well it works of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or dummy treatment (placebo). Outcome assessments will occur at 1 week and 1 month following psilocybin administration.","whoItsFor":["Ages 21 Years to 65 Years","Age 21 to 65 years old","At least high school level of education","Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report","Agree not to take any PRN medications on the mornings of drug sessions","Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study","Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year","Condoms alone are not considered highly effective"],"whoShouldSkip":["Non-English speakers and those with language or hearing impairments","Left-handedness (assessed by the Edinburgh Handedness Inventory)","Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)","History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder","Current use of neuropsychiatric medications, including but not limited to typical/atypical antidepressants, antipsychotics, and stimulants","Lifetime history of substance use disorder","Current (within past six months) substance use disorder of moderate or greater severity"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, Pimavanserin, or Inactive Placebo. The registry lists allocation as randomized. Twenty healthy adults (≥21 years old) will be enrolled to measure the how well it works of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.094Z"},{"nctId":"NCT07610369","title":"The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","officialTitle":"The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.","conditions":["Depression","Parkinson's Disease (PD)"],"keywords":["Parkinson's Diesease","Depression","Psilocybin","Psilocybin therapy","Movement disorder"],"interventions":[{"type":"DRUG","name":"Psilocybin (drug)"},{"type":"DRUG","name":"Psilocybin (drug)"}],"enrollment":40,"startDate":"2026-07-10","completionDate":"2030-07","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to understand and provide informed consent\n* Comfortable speaking and writing in English\n* Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an \"on\" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)\n* Have no changes in medication or major surgical procedures anticipated for treatment duration\n* Have a score \\>/=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline.\n* For people who can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy.\n* Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study.\n* Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions.\n* Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree not to use products or substances containing Δ9-tetrahydrocannabinol (THC) and/or cannabidiol for at least 7 days prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to not use non-prescribed narcotics (eg. heroine, fentanyl), depressants (eg. Barbiturates, benzodiazepines) and/or inhalants for the duration of participation in the trial.\n* Agree not to consume alcoholic beverages for at least 24 hours prior to and 24 hours following each psilocybin administration session.\n* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating care and is available for consultation with the study medical monitor.\n\nExclusion Criteria:\n\n* Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.\n* Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\<24.\n* Symptomatic orthostatic hypotension.\n* Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and/or TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.\n* Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial.\n* Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial.\n* Current severity of psychiatric symptoms warranting immediate treatment as determined by the study medical staff (e.g. due to inability to provide for basic needs/safety). The study medical staff will assess these individuals, determine the appropriate level of care, and coordinate with the individual's primary providers to ensure close follow-up.\n* High risk of self-harm/suicide, as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) risk screen, specifically: participant answers \"yes\" to item 4 or 5 suggesting intent to act on suicidal thoughts OR participant has made a serious suicide attempt within the 12 months prior to entry into this trial.\n* History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features.\n* History of delusional symptoms or any other psychotic symptoms accompanied by a loss of insight. Exceptions may be made at the investigators' discretion in cases of a history of psychotic symptoms that were attributable to substance or medication use.\n* Current delusional symptoms or any other psychotic symptoms accompanied by a loss of insight.\n* History of a schizophrenia spectrum disorder in a first-degree relative.\n* History of bipolar disorder 1 in a first-degree relative, in whom illness onset was prior to age 40.\n* Current or history of meeting DSM-5 criteria for a bipolar disorder.\n* Current or history within the last 2 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder, excluding caffeine.\n* Currently meeting DSM-5 criteria for another psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin treatment procedures as determined by the investigators.\n* History of meeting DSM-5 criteria for Hallucinogen Persisting Perception Disorder (HPPD).\n* History of using any psychedelic substances including psilocybin, lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy-methamphetamine (MDMA), or methylone during the past 6 months at dosages and/or frequencies determined clinically significant by the investigators.\n* Cancer with known central nervous system (CNS) involvement, CNS infection, or other major CNS disease aside from PD.\n* Epilepsy or other seizure disorder in adulthood.\n* Supplemental oxygen requirement.\n* Allergy or intolerance to any of the materials contained in the drug products.\n* Renal insufficiency defined as creatinine clearance \\< 40 ml/min using Cockraft and Gault equation\n* Insufficiently managed endocrine conditions, including diabetes mellitus and clinically significant thyroid dysfunction.\n* Cardiovascular conditions, including:\n\n  * Elevated blood pressure defined as systolic blood pressure (SBP) \\>150 or diastolic blood pressure (DBP) \\>95 taken during Enrollment\n  * Tachycardia defined as heart rate (HR) \\>90 beats per minute taken during Enrollment\n  * Bradycardia defined as HR \\<50 bpm taken during Enrollment\n  * Angina\n  * History of stroke within the past year\n  * Clinically significant ECG abnormality as determined by the investigators, including but not limited to QTc \\> 450\n* Hepatic dysfunction as indicated by any of the following laboratory values:\n\n  * AST \\> 3 x upper limit of normal\n  * ALT \\> 3 x upper limit of normal\n  * Total bilirubin \\> 3.0 mg/dl\n* Use of any of the following concomitant medications AND inability/unwillingness to discontinue for at least 5 times the elimination half-life of the agent (specific exceptions are noted) prior to psilocybin administration, including:\n\n  * Agents that may be associated with serotonin syndrome:\n\n    * MAO inhibitors (participants must have discontinued 2 weeks prior to baseline)\n    * St. John's Wort\n    * S-adenosyl-methionine (SAM-e)\n    * 5-Hydroxytryptophan (5-HTP)\n    * Dextromethorphan\n    * Opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n    * Lithium\n    * Linezolid\n    * Buspirone\n  * Agents that may interact with psilocybin metabolism/effects:\n\n    * Serotonin antagonists (e.g., cyclobenzaprine, ondansetron)\n    * Antipsychotics\n    * Other dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine)\n    * Nicotine\n    * Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g. valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors)\n    * L-methyl folate (\\>/= 7.5mg/day)\n    * Efavirenz\n  * Agents that may increase the risk of psychotic symptoms:\n\n    * Stimulants (e.g. modafinil, methylphenidate, atomoxetine, methamphetamine, cocaine, amphetamine derivatives)\n    * Anticholinergics (e.g. benztropine, trihexyphenidyl, scopolamine, hyoscyamine)\n    * Systemic steroids\n  * Tricyclic antidepressants\n* Other medical condition or diagnosis, concomitant medication(s), physical exam finding, laboratory abnormality or health risk identified that precludes participation in study procedures due to safety or feasibility concerns at the discretion of the investigators.","locations":[{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sophie Holmes, PhD","phone":"203-685-4066","email":"sophie.holmes@yale.edu"},{"name":"Gerard Sanacora, MD","phone":"","email":"gerard.sanacora@yale.edu"}],"primaryOutcomes":["Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)"],"hasResults":false,"conditionSlugs":["parkinson","depression"],"drugSlugs":["psilocybin"],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Phase 2: testing Psilocybin (drug) for Depression","inPlainEnglish":"This study wants to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.","whoItsFor":["Ages 40 Years to 80 Years","Comfortable speaking and writing in English","Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an \"on\" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)","Have no changes in medication or major surgical procedures anticipated for treatment duration","Have a score \\>/=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline","Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions","Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session","Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session"],"whoShouldSkip":["Any indication of forms of parkinsonism other than idiopathic Parkinson's disease","Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\<24","Symptomatic orthostatic hypotension","Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and/or TMS is permitted; last treatment must be at least 30 days prior to entry into this trial","Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial","Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial","History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (drug), or Psilocybin (drug). The registry lists allocation as randomized. This study wants to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.101Z"},{"nctId":"NCT07611747","title":"Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)","officialTitle":"Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Instituto de Investigación Marqués de Valdecilla","sponsorClass":"OTHER","summary":"PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).\n\nPatients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2/OP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.\n\nPatients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2/OP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \\<55 mg/dL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.","conditions":["Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Systemic Lupus Erythematosus (SLE)","Carotid Artery Diseases","Cardio Vascular Disease","Atheroscleroses","Axial Spondyloarthritis"],"keywords":["Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Carotid Ultrasound"},{"type":"DRUG","name":"High-intensity lipid-lowering therapy"},{"type":"OTHER","name":"Standard care according to ESC 2021 guidelines"}],"enrollment":1944,"startDate":"2026-04-22","completionDate":"2031-04-22","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients aged ≥50 years who have provided written informed consent.\n2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:\n\n   * Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria\n   * Psoriatic arthritis (PsA) according to CASPAR criteria\n   * Axial spondyloarthritis (AxSpA) according to ASAS criteria\n   * Systemic lupus erythematosus (SLE) according to ACR/EULAR 2019 criteria\n3. Low-to-moderate cardiovascular risk according to SCORE2/OP classification.\n\nExclusion Criteria:\n\n1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.\n2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.\n3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).","locations":[{"facility":"Hospital General Universitario de Alicante","city":"Alicante","state":"Alicante","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Elche","city":"Elche","state":"Alicante","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Vega Baja de Orihuela","city":"Orihuela","state":"Alicante","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebrón","city":"Barcelona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Laredo","city":"Laredo","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Marqués de Valdecilla","city":"Santander","state":"Cantabria","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sierrallana","city":"Torrelavega","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario de Ciudad Real","city":"Ciudad Real","state":"Ciudad Real","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Reina Sofía","city":"Córdoba","state":"Córdoba","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Son LLàtzer","city":"Palma","state":"Isla Baleares","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Gran Canaria Dr. Negrín","city":"Las Palmas de Gran Canaria","state":"Las Palmas","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario La Paz","city":"Madrid","state":"Madrid","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Ramón y Cajal","city":"Madrid","state":"Madrid","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hispital Universitario Virgen de la Arrixaca","city":"Murcia","state":"Murcia","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Canarias","city":"San Cristóbal de La Laguna","state":"Santa Cruz de Tenerife","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Basurto","city":"Bilbao","state":"Vizcaya","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Araba","city":"Vitoria-Gasteiz","state":"Álava","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence of Major Adverse Cardiovascular Events (MACE)"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["alicante-spain","elche-spain","orihuela-spain","barcelona-spain","laredo-spain","santander-spain","torrelavega-spain","ciudad-real-spain","c-rdoba-spain","palma-spain","las-palmas-de-gran-canaria-spain","madrid-spain","murcia-spain","san-crist-bal-de-la-laguna-spain","bilbao-spain","vitoria-gasteiz-spain"],"enrichment":{"headline":"Phase 4: testing High-intensity lipid-lowering therapy for Rheumatoid Arthritis (RA)","inPlainEnglish":"PREVENER is a randomly assigned, open-label, multicenter, phase IV clinical trial designed to measure the how well it works and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD). Patients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population.","whoItsFor":["Ages 50 Years to any","Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:","Rheumatoid arthritis (RA) according to ACR/EULAR 2010 criteria","Psoriatic arthritis (PsA) according to CASPAR criteria","Axial spondyloarthritis (AxSpA) according to ASAS criteria","Systemic lupus erythematosus (SLE) according to ACR/EULAR 2019 criteria","Low-to-moderate cardiovascular risk according to SCORE2/OP classification"],"whoShouldSkip":["Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk","Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice","Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe)"],"whatHappens":"If you join, the listed intervention(s) are Carotid Ultrasound, High-intensity lipid-lowering therapy, or Standard care according to ESC 2021 guidelines. The registry lists allocation as randomized. PREVENER is a randomly assigned, open-label, multicenter, phase IV clinical trial designed to measure the how well it works and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 1,944 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.948Z"},{"nctId":"NCT07612878","title":"The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry","officialTitle":"The Study of Chronic Obstructive Pulmonary Disease (COPD) Participants Treated With Dupilumab (STRIDE) Registry","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"The STRIDE Registry will evaluate the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD. Secondary objectives are to determine whether treatment with dupilumab reduces moderate and/or severe COPD exacerbations; to determine the impact of treatment on lung function in COPD participants; to determine whether treatment with dupilumab improves the quality of life in COPD participants; and to describe safety of dupilumab among COPD participants. The external control cohort will include participants with COPD from the National Patient-Centered Clinical Research Network (PCORnet) consortium who are not being treated with dupilumab. In addition, chest images will be collected and banked for future research projects and consented participants will perform home spirometry.","conditions":["COPD (Chronic Obstructive Pulmonary Disease)"],"keywords":["COPD","Dupilumab","Dupixent","Chronic Obstructive Pulmonary Disease","Exacerbation","Home Spirometry"],"interventions":[{"type":"DRUG","name":"Cohort 1: Dupilumab"},{"type":"OTHER","name":"Cohort 2: usual care only"}],"enrollment":350,"startDate":"2026-08-06","completionDate":"2029-06-30","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* COPD patients who are newly referred to start dupilumab treatment\n* Age ≥ 40 years\n* Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit\n\nExclusion Criteria:\n\n* Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)\n* Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments\n* Patients currently participating in any interventional clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial","locations":[{"facility":"IU Health Pulmonology & Critical Care Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kansas","city":"Lawrence","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Respire Institute","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Activian Clinical Research","city":"Kingwood","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Lung & Sleep Institute of North Texas","city":"North Richland Hills","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency Trial Transparency","phone":"800-633-1610 option 6","email":"Contact-us@sanofi.com"}],"primaryOutcomes":["Participant Characteristics","Participant Characteristics","Patient Characteristics","Participant Characteristics","Patients Characteristics","Patients Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics","Patient Characteristics"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":["dupilumab"],"locationSlugs":["indianapolis-indiana","lawrence-kansas","durham-north-carolina","columbus-ohio","houston-texas","kingwood-texas","north-richland-hills-texas"],"enrichment":{"headline":"Not a traditional drug phase: testing Cohort 1: Dupilumab for COPD (Chronic Obstructive Pulmonary Disease)","inPlainEnglish":"The STRIDE Registry will measure the real-world effectiveness and safety of dupilumab in participants with COPD. The primary objective is to describe characteristics of participants newly initiated with dupilumab for COPD.","whoItsFor":["Ages 40 Years to any","COPD patients who are newly referred to start dupilumab treatment","Standard of care spirometry performed concurrently with the baseline visit or within 90 days prior to the baseline visit"],"whoShouldSkip":["Patients who have contraindication to dupilumab according to the United States Prescribing Information (USPI)","Any condition that, in the opinion of the Investigator, may interfere with the patient's ability to participate in the study, such as short life expectancy, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments","Patients currently participating in any treatment clinical trial The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 350 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.706Z"},{"nctId":"NCT07613359","title":"A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant","officialTitle":"A Double-Blind, Placebo-Controlled, Multicenter, Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Mezagitamab (TAK-079) in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Takeda","sponsorClass":"INDUSTRY","summary":"Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Antibodies are proteins made by the immune system to recognize foreign cells. Over time, this attack can damage kidney tissue and cause the transplant to fail. Because AMR can be serious, there is a need for treatments that are safe, work well, and are supported by good evidence.\n\nThe main aim of this study is to find out how safe mezagitamab is and how well adults with AMR tolerate it compared with placebo. A placebo looks like medicine but has no active ingredients. The study will also look at whether mezagitamab helps to control inflammation in the transplanted kidney and helps keep kidney function stable, compared with placebo.\n\nParticipants will be placed by chance in 1 of the 3 treatment groups in equal numbers. Two groups will receive mezagitamab in two different doses. One group will receive placebo. This means that out of every 3 participants, 2 will receive mezagitamab and 1 will receive placebo.\n\nDuring the study, participants will visit their study clinic several times.","conditions":["Antibody-Mediated Rejection (AMR)"],"keywords":["Drug Therapy","TAK-079"],"interventions":[{"type":"DRUG","name":"Mezagitamab"},{"type":"DRUG","name":"Placebo"}],"enrollment":36,"startDate":"2026-10-27","completionDate":"2029-01-15","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Key inclusion criteria:\n\n1. The participant aged 18 to 80 years.\n2. The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than \\[\\>\\] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification.\n3. Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.\n4. If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment.\n5. The participant with either human leukocyte antigen (HLA) class I and/or II DSA.\n6. eGFR \\> 30 milliliters per minute per 1.73 square meters (mL/min/1.73m\\^2).\n\nKey exclusion criteria:\n\n1. The participant has blood type A, B, AB, or O (ABO) incompatible transplant.\n2. The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.\n3. Participant likely to require renal replacement therapy within the subsequent 30 days.\n4. Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy.\n5. The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy:\n\n   a) Within 6 months of signing the informed consent form (ICF) as listed below:\n   * Complement system inhibitors (such as, eculizumab).\n   * Proteasome inhibitors (such as, bortezomib).\n   * Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab).\n   * Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below:\n   * Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis\n6. The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n7. Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded.\n8. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.\n\nKey Note: Other protocol specified inclusion and exclusion criteria apply.","locations":[{"facility":"UCLA University of California Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Hospital and Clinics","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tampa General Hospital","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cooperman Barnabas Medical Center","city":"Livingston","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health - Transplant Associates","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic - Cleveland","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Intermountain Healthcare","city":"Murray","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Virginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC)","city":"Richmond","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Froedtert and The Medical College of Wisconsin","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Friendship Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Sun Yat-sen University","city":"Guangdong","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guangxi Medical University","city":"Nanning","state":"Guangxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tongji Hospital Affiliated to Tongji Medicine University","city":"Wuhan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi'an","state":"Shaanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shandong Provincial Qianfoshan Hospital","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Bordeaux, CHU Pellegrin","city":"Bordeaux","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Henri Mondor","city":"Créteil","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Edouard Herriot (HEH)","city":"Lyon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse - Hopital Rangueil","city":"Toulouse","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kliniken Universitatsklinikum Bochum GmbH","city":"Bochum","state":"North Rhine-Westphalia","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Essen","city":"Essen","state":"North Rhine-Westphalia","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen","city":"München","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitaetsklinikum Muenster","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Japanese Red Cross Kumamoto Hospital","city":"Kumamoto","state":"Kumamoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yochomachi Clinic","city":"Shinjuku-ku","state":"Tokyo","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Niigata University Medical and Dental Hospital","city":"Niigata","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Osaka Metropolitan University Hospital","city":"Osaka","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Takeda Contact","phone":"+1-877-825-3327","email":"medinfoUS@takeda.com"}],"primaryOutcomes":["Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)","Arms A, B, and C: Number of Participants With Related TEAEs","Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs)","Arms A, B, and C: Number of Participants With AEs of Special Interest","Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation","Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","miami-florida","tampa-florida","baltimore-maryland","st-louis-missouri","livingston-new-jersey","new-york-new-york","cleveland-ohio","dallas-texas","murray-utah","richmond-virginia","milwaukee-wisconsin","beijing-china","guangdong-china","nanning-china","wuhan-china","xian-china","jinan-china","chengdu-china","hangzhou-china","bordeaux-france","cr-teil-france","lyon-france","toulouse-france","bochum-germany","essen-germany","m-nchen-germany","m-nster-germany","nagoya-japan","kumamoto-japan","shinjuku-ku-japan","niigata-japan","osaka-japan"],"enrichment":{"headline":"Phase 2: testing Mezagitamab for Antibody-Mediated Rejection (AMR)","inPlainEnglish":"Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney.","whoItsFor":["Ages 18 Years to 80 Years","The participant aged 18 to 80 years","The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than \\[\\>\\] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification","Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window","If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment","The participant with either human leukocyte antigen (HLA) class I and/or II DSA","eGFR \\> 30 milliliters per minute per 1.73 square meters (mL/min/1.73m\\^2)"],"whoShouldSkip":["The participant has blood type A, B, AB, or O (ABO) incompatible transplant","The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants","Participant likely to require renal replacement therapy within the subsequent 30 days","Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy","The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy:","Complement system inhibitors (such as, eculizumab)","Proteasome inhibitors (such as, bortezomib)"],"whatHappens":"If you join, the listed intervention(s) are Mezagitamab, or Placebo. The registry lists allocation as randomized. Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 36 people at 35 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.448Z"},{"nctId":"NCT07615426","title":"A Study of the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia","officialTitle":"A Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Phase 1b Study to Investigate the Feasibility, Safety and Tolerability of Aticaprant as Adjunctive Treatment in Participants With Schizophrenia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with placebo in participants with schizophrenia.","conditions":["Schizophrenia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Aticaprant"},{"type":"DRUG","name":"Placebo"}],"enrollment":64,"startDate":"2026-03-02","completionDate":"2027-06-21","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \\[MINI\\] for psychotic disorders\n* The participant must be on a stable dose of only one atypical antipyschotic medication\n* Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening\n* At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit\n* If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase\n\nExclusion criteria:\n\n* Has one or more of the current or prior (lifetime) diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnoses (based on the MINI for psychotic disorders): intellectual disability, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, psychotic disorder not otherwise specified (NOS), substance-induced psychotic disorder, bipolar disorder, major depressive disorder (recurrent or current episode)\n* Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)\n* Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire\n* Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)\n* Has current homicidal ideation/intent, per the investigator's clinical judgment","locations":[{"facility":"CNS Network","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US Inc","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uptown Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Western Michigan University","city":"Kalamazoo","state":"Michigan","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"Neurobehavioral Research Inc","city":"Cedarhurst","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evolution Research Group","city":"Staten Island","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Community Clinical Research, Inc.","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research, LLC","city":"Richardson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Screen Pass Rate","Exploratory Assessment-Specific Completion Rate","Total Assessment Completion Rate","Study Completion Rate","Adverse Events (AEs) Including AEs of Special Interest (AESI)","Number of Participants with Abnormalities in Vital Signs","Number of Participants with Abnormalities in 12-lead Electrocardiogram (ECG)","Number of Participants with Abnormalities in Laboratory Parameters","Number of Participants Reporting Changes in Body Weight","Number of Participants Reporting Changes in Body Mass Index (BMI)","Suicidality Using the Columbia Suicide Severity Rating Scale (C-SSRS) Over Time","Extrapyramidal Symptoms (EPS) Assessment Using the Modified Simpson-Angus Scale (MSAS) Total Score"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["garden-grove-california","atlanta-georgia","chicago-illinois","kalamazoo-michigan","cedarhurst-new-york","staten-island-new-york","austin-texas","richardson-texas"],"enrichment":{"headline":"Phase 1: testing Aticaprant for Schizophrenia","inPlainEnglish":"This study wants to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments. It will also assess how safe and tolerable aticaprant is when compared with dummy treatment (placebo) in participants with schizophrenia.","whoItsFor":["Ages 18 Years to 60 Years","Clinically stable with a diagnosis of schizophrenia confirmed by the mini international neuropsychiatric interview \\[MINI\\] for psychotic disorders","The participant must be on a stable dose of only one atypical antipyschotic medication","Must be receiving outpatient treatment for schizophrenia from a psychiatric provider at the time of screening","At the Baseline visit, must have a presence of permitted background antipsychotic medication based on blood samples drawn at the screening visit","If taking an antidepressant or anxiolytic, no dose changes are allowed to have occurred within 8 weeks prior to screening or throughout the double blind treatment phase"],"whoShouldSkip":["Has a history of moderate-to-severe substance use disorder, including alcohol use disorder, according to DSM-5 criteria within 6 months before screening except for nicotine or caffeine (based on the MINI and clinical judgment)","Current cannabis (marijuana, pot, grass, hash, etcetera) use exceeds 3 to 5 times over the past 30 days as measured by items from the national survey on drug use and health (NSDUH) questionnaire","Has a history in the past 6 months of a peptic ulcer, or lifetime history of upper gastrointestinal bleeding, or known untreated helicobacter pylori infection, or has a diagnosis of zollinger-ellison syndrome (ZES)","Has current homicidal ideation/intent, per the investigator's clinical judgment"],"whatHappens":"If you join, the listed intervention(s) are Aticaprant, or Placebo. The registry lists allocation as randomized. This study wants to see how feasible it is to enroll participants with schizophrenia and for them to complete the study/assessments.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 64 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.041Z"},{"nctId":"NCT07616037","title":"Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS","officialTitle":"A Preliminary Study to Explore the Efficacy of a GLP-1/FGF21 Dual Agonist (HEC88473) in Patients With Polycystic Ovary Syndrome (PCOS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Shanghai Zhongshan Hospital","sponsorClass":"OTHER","summary":"Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age. It is characterized by oligo-ovulation or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology. In addition, PCOS is frequently accompanied by multiple metabolic abnormalities, including insulin resistance, obesity, impaired glucose tolerance, and dyslipidemia. Clinical studies have demonstrated that treatment with glucagon-like peptide-1 receptor agonists (GLP-1RAs) in women with PCOS results in significant weight reduction, decreased free testosterone levels, improvement in menstrual regularity, and increased clinical pregnancy rates. Fibroblast growth factor 21 (FGF21) has been shown to enhance insulin sensitivity, promote fatty acid oxidation, and improve lipid distribution.\n\nHEC88473 is a novel long-acting dual agonist targeting both the glucagon-like peptide-1 (GLP-1) receptor and the fibroblast growth factor 21 (FGF21) receptor. This study is initiated to evaluate the clinical efficacy of HEC88473 in women with PCOS and to explore its potential as a new therapeutic option for the management of PCOS.","conditions":["PCOS (Polycystic Ovary Syndrome)"],"keywords":["PCOS","GLP-1/FGF21 dual agonist"],"interventions":[{"type":"DRUG","name":"GLP-1/FGF21 dual agonist (HEC88473)"}],"enrollment":30,"startDate":"2026-06","completionDate":"2027-06","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 40 years.\n* Female.\n* No plan for pregnancy from the time of signing the informed consent until 2 months after the last dose of study drug, and willingness to use study-approved contraceptive methods during this period.\n* Fulfillment of at least two of the diagnostic criteria for PCOS according to the 2023 International Guideline, including:\n\n  1. Irregular menstrual cycles:\n\n     1-3 years after menarche: cycle length \\<21 days or \\>45 days; ≥3 years after menarche to perimenopause: cycle length \\<21 days or \\>35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any cycle \\>90 days;\n  2. Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter \\<10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;\n  3. Hyperandrogenism: biochemical hyperandrogenism (total testosterone \\>1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey \\[mFG\\] score \\>4).\n\nExclusion Criteria:\n\n* Use of hormonal contraceptives within 2 months prior to screening.\n* History of acute or chronic pancreatitis or pancreatic injury.\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B.\n* History of type 1 or type 2 diabetes mellitus.\n* Presence of other endocrine disorders that may cause polycystic ovarian morphology, such as 21-hydroxylase deficiency, pituitary prolactinoma, hypothyroidism, or Cushing's syndrome.\n* Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH agonists or antagonists, anti-androgens, and gonadotropins.\n* Current use of other medications that may affect metabolism, with discontinuation less than 1 month prior to screening, including metformin, thiazolidinediones, and SGLT2 inhibitors.\n* History of bariatric surgery within the past 12 months.\n* Treatment with GLP-1 receptor agonists within the past 12 months.\n* Pregnancy or lactation.\n* Presence of other serious diseases of major organs such as the heart, liver, or kidney, or any malignancy.\n* Any other condition that, in the investigator's opinion, may interfere with the evaluation of efficacy or safety or render the participant unsuitable for this study.","locations":[{"facility":"Zhongshan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jingjing JIANG, MD, PhD","phone":"86-021-64041990","email":"jiang.jingjing@zs-hospital.sh.cn"}],"primaryOutcomes":["Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment"],"hasResults":false,"conditionSlugs":["obesity","pcos"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 2: testing GLP-1/FGF21 dual agonist (HEC88473) for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age. It is characterized by oligo-ovulation or anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Age between 18 and 40 years","Fulfillment of at least two of the diagnostic criteria for PCOS according to the 2023 International Guideline, including:","Irregular menstrual cycles:","1-3 years after menarche: cycle length \\<21 days or \\>45 days; ≥3 years after menarche to perimenopause: cycle length \\<21 days or \\>35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any cycle \\>90 days;","Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter \\<10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;","Hyperandrogenism: biochemical hyperandrogenism (total testosterone \\>1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey \\[mFG\\] score \\>4)"],"whoShouldSkip":["Use of hormonal contraceptives within 2 months prior to screening","History of acute or chronic pancreatitis or pancreatic injury","Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B","History of type 1 or type 2 diabetes mellitus","Presence of other endocrine disorders that may cause polycystic ovarian morphology, such as 21-hydroxylase deficiency, pituitary prolactinoma, hypothyroidism, or Cushing's syndrome","Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH agonists or antagonists, anti-androgens, and gonadotropins","Current use of other medications that may affect metabolism, with discontinuation less than 1 month prior to screening, including metformin, thiazolidinediones, and SGLT2 inhibitors"],"whatHappens":"If you join, the listed intervention(s) are GLP-1/FGF21 dual agonist (HEC88473). The registry lists allocation as na. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disorder among women of reproductive age.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.798Z"},{"nctId":"NCT07616128","title":"Study of EVO756 in Adults With Migraine","officialTitle":"A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Evommune, Inc.","sponsorClass":"INDUSTRY","summary":"This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.","conditions":["Migraine"],"keywords":["Migraine Disease","Migraine Disorder","Migraine Disorders","Migraine Headache","Migraine Headaches","Migraine","Migraines","Migraine in Adults","Migraine Prophylaxis","Migraine With Aura","Migraine With or Without Aura","Migraine With and Without Aura","Migraine Without Aura","Episodic Migraine Headache","Chronic Migraine Headache"],"interventions":[{"type":"DRUG","name":"EVO756, Dose 1"},{"type":"DRUG","name":"EVO756, Dose 2"},{"type":"DRUG","name":"Placebo"}],"enrollment":330,"startDate":"2026-07-29","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Adults aged 18 to \\<65 years\n* Migraine with or without aura, per ICHD-3 criteria\n* History of failure with prior preventive migraine treatments\n* Not currently using migraine preventive therapy\n\nKey Exclusion Criteria:\n\n* Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders\n* Use of certain medications\n* Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities","locations":[{"facility":"Trialsphere Corp","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Buena Park Research Center","city":"Buena Park","state":"California","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Neuro Pain Research Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Salma Health La Jolla","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CA Medical Clinic for Headache","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research dba Flourish Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Denver Neurological Clinic","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hasbani Neurology","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Institute for Neurology and Headache","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Jacksonville","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Apple Medical Research Group, Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Blessed Healthcase & Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Research Center, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, Inc.","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vantage Clinical Trials","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Premiere Research Institute at Palm Beach Neurology","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Site-Decatur-Alcanza","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Center of New England P.C.","city":"Foxborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass Institute of Clinical Research","city":"Westborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Headache and Neurological Institute","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quest Research Institute-Alcanza","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Papillion Research Center - Avacare Clinical Research","city":"Papillion","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bio Behavoural health","city":"Toms River","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinosis - Dent Neurologic Instite","city":"Amherst","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asheville Neurology Specialists, Pa","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eximia Research NC","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuroScience Research Center","city":"Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dayton Center for Neurological Disorders","city":"Centerville","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials of South Carolina","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Campbell Clinical Research","city":"Franklin","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SFF Medical Research Group LLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercury Clinical Research Inc. - Houston Neurology Associates","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedStar Health: Headache Center at McLean","city":"McLean","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vaught Neurological Services","city":"Crab Orchard","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paratus Clinical Research Western Sydney","city":"Blacktown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Sunshine Melbourne","city":"Saint Albans","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre de Recherche St-Louis","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Auckland","city":"Auckland","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Christchurch","city":"Christchurch","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Hutt Valley","city":"Upper Hutt","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Kapiti","city":"Waikanae","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research - Wellington","city":"Wellington","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nichole Baio","phone":"(650) 319-4553","email":"nichole.baio@evommune.com"}],"primaryOutcomes":["Mean change from baseline in the number of monthly migraine days (MMD)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["chandler-arizona","buena-park-california","fresno-california","la-jolla-california","los-angeles-california","walnut-creek-california","denver-colorado","new-haven-connecticut","stamford-connecticut","jacksonville-florida","miami-florida","orlando-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","decatur-georgia","foxborough-massachusetts","westborough-massachusetts","ann-arbor-michigan","farmington-hills-michigan","papillion-nebraska","toms-river-new-jersey","amherst-new-york","asheville-north-carolina","raleigh-north-carolina","canton-ohio","centerville-ohio","charleston-south-carolina","franklin-tennessee","austin-texas","dallas-texas","houston-texas","mclean-virginia","crab-orchard-west-virginia","blacktown-australia","saint-albans-australia","qu-bec-canada","auckland-new-zealand","christchurch-new-zealand","upper-hutt-new-zealand","waikanae-new-zealand","wellington-new-zealand"],"enrichment":{"headline":"Phase 2: testing EVO756, Dose 1 for Migraine","inPlainEnglish":"This study will measure the how well it works and safety of EVO756 against dummy treatment (placebo) in adults with migraine.","whoItsFor":["Ages 18 Years to 64 Years","Adults aged 18 to \\<65 years","Migraine with or without aura, per ICHD-3 criteria","History of failure with prior preventive migraine treatments","Not currently using migraine preventive therapy"],"whoShouldSkip":["Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders","Use of certain medications","Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities"],"whatHappens":"If you join, the listed intervention(s) are EVO756, Dose 1, EVO756, Dose 2, or Placebo. The registry lists allocation as randomized. This study will measure the how well it works and safety of EVO756 against dummy treatment (placebo) in adults with migraine.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 330 people at 45 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.292Z"},{"nctId":"NCT07616206","title":"Cadisegliatin as Adjunctive Therapy to Insulin in Participants With Type 1 Diabetes Who Are Using Hybrid Closed Loop (HCL) Systems","officialTitle":"Hybrid CATT1: Hybrid Closed Loop Insulin Pumps With Cadisegliatin as Adjunctive Treatment in Patients With Type 1 Diabetes A Phase 2a Double Blind Randomized Cross-Over Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"vTv Therapeutics","sponsorClass":"INDUSTRY","summary":"TTP399-206 is a Phase 2a multicenter double blind cross over randomized study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomized to either receive blinded cadisegliatin 800 mg QD as an adjunctive therapy to their insulin treatment or placebo QD along with their insulin treatment. The trial begins with a screening period of up to 2 weeks, followed by a device training and insulin adjustment period of 1-2 weeks leading into the first double-blind treatment period of 6 weeks. There will then be a washout period of 2 weeks followed by the second double-blind treatment period of 6 weeks where the participants will cross-over to the treatment that they did not receive in the first treatment period.","conditions":["Type 1 Diabetes (T1D)"],"keywords":["Hybrid Closed Loop"],"interventions":[{"type":"DRUG","name":"Cadisegliatin 800 mg QD"},{"type":"DRUG","name":"Placebo"}],"enrollment":40,"startDate":"2026-09-29","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Participants \\>= 18 years of age\n* Fasting C-peptide levels \\<0.6 ng/ml\n* Average TIR \\< 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1\n* Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration\n* Willing to wear a study provided CGM for study duration\n* Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN\n\nKey Exclusion Criteria:\n\n* Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease.\n* Have been hospitalized for DKA within 3 months\n* Have uncontrolled hypothyroidism or hyperthyroidism\n* Have QTcF interval \\> 450 msec for males or \\> 470 msec for females\n* Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias\n* Have persistent, uncontrolled hypertension\n* Have clinically significant cardiovascular or cerebrovascular disease\n* Have proliferative retinopathy or maculopathy requiring acute treatment\n* Have a serious concomitant systemic disorder including but not limited to HIV or active Hep B or Hep C\n* Have been diagnosed and/or treated for malignancy within 3 years\n* Have used any of the following medications within the specified time periods: any non-insulin anti-diabetic therapies (e.g.SGLT-2 inhibitors, GLP-1 receptor agonists, metformin, sulfonylureas, DPP-4 inhibitors, pramlintide, a-glucosidase inhibitors, or glucose dependent insulinotropic polypeptide agonists) within 30 days, antipsychotic medications (e.g. olanzapine, risperidone, clozapine, quetiapine, and haloperidol) within 30 days, systemic corticosteroids for ≥7 days for a temporary medical condition within 30 days,","locations":[{"facility":"Paradigm Clinical Research -Modesto","city":"Modesto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Barbara Davis Center for Diabetes","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta Diabetes Associates","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Eastowne Medical Office Building","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Diabetes & Endocrinology, P.A.","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meaghan Marnell","phone":"(336) 888-0435","email":"clinicaltrials@vtvtherapeutics.com"}],"primaryOutcomes":["To assess the change in Time in Range (TIR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["modesto-california","san-diego-california","aurora-colorado","atlanta-georgia","chapel-hill-north-carolina","austin-texas"],"enrichment":{"headline":"Phase 2: testing Cadisegliatin 800 mg QD for Type 1 Diabetes (T1D)","inPlainEnglish":"TTP399-206 is a Phase 2a multicenter double blind cross over randomly assigned study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes. Participants using a hybrid closed loop insulin pump to manage their diabetes will be randomly assigned to either receive blinded cadisegliatin 800 mg QD as an added on top of your current treatment therapy to their insulin treatment or dummy treatment (placebo) QD along with their insulin treatment.","whoItsFor":["Ages 18 Years to any","Participants \\>= 18 years of age","Fasting C-peptide levels \\<0.6 ng/ml","Average TIR \\< 70% recorded on their personal CGM data collected over the past 7 days prior to Visit 1","Currently on a hybrid closed loop device for at least 3 months and willing to stay on the same model of pump device for study duration","Willing to wear a study provided CGM for study duration","Total bilirubin ≤2×ULN, ALT and AST ≤3×ULN"],"whoShouldSkip":["Have Type 2 Diabetes Mellitus (DM), monogenic diabetes, maturity-onset diabetes, other unusual or rare forms of DM, or diabetes resulting from a secondary disease","Have been hospitalized for DKA within 3 months","Have uncontrolled hypothyroidism or hyperthyroidism","Have QTcF interval \\> 450 msec for males or \\> 470 msec for females","Have a personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias","Have persistent, uncontrolled hypertension","Have clinically significant cardiovascular or cerebrovascular disease"],"whatHappens":"If you join, the listed intervention(s) are Cadisegliatin 800 mg QD, or Placebo. The registry lists allocation as randomized. TTP399-206 is a Phase 2a multicenter double blind cross over randomly assigned study of cadisegliatin in participants with T1D using hybrid closed loop systems to manage their diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.494Z"},{"nctId":"NCT07618208","title":"Student Precarity and Psychiatry","officialTitle":"Impact of Precarity on the Emergence of Psychiatric Disorders and the Use of Care Among Students","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Assistance Publique - Hôpitaux de Paris","sponsorClass":"OTHER","summary":"Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021. This phenomenon particularly affects students, who are already identified as being at greater risk of mental health disorders than the general population. Medical students seem to be particularly vulnerable: in 2021, a national study showed very high rates of depression and suicidal thoughts in this population. The main factor associated with depression was the feeling of financial hardship.\n\nStudents often face multiple forms of insecurity. Financially, they have limited resources and struggle to cover their basic needs such as housing, food and healthcare. Socially, many experience significant isolation, particularly when they are away from their families or under pressure from their studies. All of this has a significant impact on their mental health. Unfortunately, many students do not seek help due to lack of time, resources, or awareness of support services. The 2021 study showed that only one-third of medical students suffering from depression received appropriate treatment.\n\nThe aim of our study is to assess the impact of precariousness on the onset of psychiatric disorders and on the use or non-use of healthcare services.\n\nOur study will involve nearly 45,000 students from PSL and UPC universities. It is based on a longitudinal cohort (via questionnaires) over three years. The aim is to identify precisely the different aspects of student precariousness (housing, transport, isolation, economic difficulties, etc.) and their link with psychological distress. The study will measure the extent of the phenomenon and identify modifiable factors that could be targeted by preventive measures. The results will enable us to better target preventive measures and propose concrete solutions to improve students' well-being and promote their success.","conditions":["Depressive Disorder, Major","Generalized Anxiety Disorder","Suicidal Ideation","Loneliness"],"keywords":["Students","Depression","Use of care","Precarity"],"interventions":[{"type":"OTHER","name":"Questionnaires"}],"enrollment":45000,"startDate":"2026-10-19","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Student enrolled at Paris Sciences et Lettres University (PSL, 17,000 students) or the Faculty of Health Sciences at Paris Cité University (UPC, 28,000 students),\n* Aged 18 or over,\n* Fluent in French,\n* Affiliated to a health insurance.\n\nExclusion Criteria:\n\n* Applicants under the age of 18,\n* Not enrolled at PSL universities or the UPCS Faculty of Health,\n* Insufficient level of French.","locations":[{"facility":"Hôtel-Dieu hospital - APHP","city":"Paris","state":"IDF","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cédric LEMOGNE, PR","phone":"00331 42 34 85 76","email":"cedric.lemogne@aphp.fr"},{"name":"Marie Benhammani-Godard","phone":"0033158411190","email":"marie.godard@aphp.fr"}],"primaryOutcomes":["Composite International Diagnostic Interview Short-Form (CIDI-SF)","Composite International Diagnostic Interview Short-Form (CIDI-SF)","Use of care","Use of care","Precarity","Precarity"],"hasResults":false,"conditionSlugs":["depression","anxiety"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Not a traditional drug phase: Questionnaires for Depressive Disorder, Major","inPlainEnglish":"Since the COVID-19 pandemic, mental health disorders have increased significantly, particularly among young people. In France, the proportion of young people aged 18 to 25 suffering from depression almost doubled between 2017 and 2021.","whoItsFor":["Ages 18 Years to any","Student enrolled at Paris Sciences et Lettres University (PSL, 17,000 students) or the Faculty of Health Sciences at Paris Cité University (UPC, 28,000 students),","Affiliated to a health insurance"],"whoShouldSkip":["Applicants under the age of 18,","Not enrolled at PSL universities or the UPCS Faculty of Health,","Insufficient level of French"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 45,000 people at Paris. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.109Z"},{"nctId":"NCT07619521","title":"Testing the Combination of Anti-Cancer Drugs, Selumetinib and DS-8201a (Trastuzumab Deruxtecan), for Advanced Pancreatic Ductal Adenocarcinoma","officialTitle":"Phase I/II Study of the MEK Inhibitor Selumetinib Plus DS-8201a (Trastuzumab Deruxtecan) in KRAS-Mutant, HER2-Expressing Pancreatic Ductal Adenocarcinoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. DS-8201a is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving selumetinib with DS-8201a may be safe, tolerable and/or effective in treating patients with advanced, unresectable or metastatic pancreatic ductal adenocarcinoma.","conditions":["Advanced Pancreatic Ductal Adenocarcinoma","Metastatic Pancreatic Ductal Adenocarcinoma","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","Unresectable Pancreatic Ductal Adenocarcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Diagnostic Imaging Testing"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"PROCEDURE","name":"Multigated Acquisition Scan"},{"type":"DRUG","name":"Selumetinib"},{"type":"BIOLOGICAL","name":"Trastuzumab Deruxtecan"}],"enrollment":31,"startDate":"2027-06-01","completionDate":"2028-09-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Review of eligibility criteria by the study principal investigator (PI) is required prior to enrollment\n* Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas\n* Patients must have unresectable or metastatic disease with KRAS mutation per Next Generation Sequencing (NGS) tumor testing and HER2 immunohistochemistry (IHC) positivity (2+ or above for dose escalation and per decision rule for phase II), as determined by a Clinical Laboratory Improvement Act (CLIA)-certified kit using gastric cancer criteria\n* Patients must have measurable disease that can fulfill Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria\n* Patients must have exposure to at least one line of systemic chemotherapy for metastatic or unresectable PDAC (for both escalation and phase II cohorts) or a documented patient decision to forego therapy that has an otherwise proven survival advantage (for escalation cohort only)\n* Patients who have received prior topoisomerase inhibitors including irinotecan and nanoliposomal irinotecan will be eligible for this study\n* Only 1 prior line of therapy for metastatic or unresectable PDAC will be allowed for patients in the phase II cohort. Adjuvant or neoadjuvant therapy does not count, assuming it was completed \\> 6 months prior to the start of systemic therapy for metastatic or unresectable disease\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of selumetinib (AZD6244 hydrogen sulfate) in combination with DS-8201a (trastuzumab deruxtecan) in patients \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%). Regardless of performance status, enrollment should be based on the judgment of the treating physician that the patient will be able to be safely treated with the proposed therapeutic intervention\n* Hemoglobin ≥ 9 g/dL (within 14 days of enrollment)\n\n  * No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment\n* Leukocytes ≥ 3,000/mcL (within 14 days of enrollment)\n* Absolute neutrophil count ≥ 1,500/mcL (within 14 days of enrollment)\n\n  * No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment\n* Platelets ≥ 100,000/mcL (within 14 days of enrollment)\n* Total bilirubin ≤ 1.5 × institutional upper limit of normal (ULN), (\\< 3 × ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) (within 14 days of enrollment)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])/ alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) \\< 5 × ULN in participants with liver metastases (within 14 days of enrollment)\n* Serum albumin ≥ 2.5 g/dL (within 14 days of enrollment)\n* International Normalized Ratio (INR)/Prothrombin Time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (within 14 days of enrollment)\n* Creatine phosphokinase (CPK) ≤ 2.5 × ULN (within 14 days of enrollment)\n* Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\\^2 (within 14 days of enrollment)\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging, performed at least 6 months after central nervous system (CNS)-directed therapy, shows no evidence of progression\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must undergo a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible, patients must be NYHA Class II or better and have no history of myocardial infarction within 6 months prior to enrollment, no symptomatic congestive heart failure (NYHA Class IIb-IV), and no troponin levels consistent with myocardial infarction (as defined by the manufacturer) within 28 days prior to enrollment\n* Patients must have a baseline left ventricular ejection fraction (LVEF) ≥ 50% as measured by echocardiogram (ECHO) or mutilated acquisition scan (MUGA) scan within 28 days before randomization/enrollment\n* Patients must be willing to undergo baseline ophthalmic evaluation, including visual acuity and slit-lamp examination\n* The effects of selumetinib (AZD6244 hydrogen sulfate) and DS-8201a (trastuzumab deruxtecan) on the developing human fetus are unknown. For this reason and because MEK inhibitor agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 7 months (for WOCBP) or 4 months (for men) after completion of drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \\[FSH\\] \\> 40 mIU/mL and estradiol \\< 40 pg/mL \\[\\< 147 pmol/L\\] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method\n* Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study\n* Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients with prior MEK inhibitor, ERK inhibitor, or HER2-directed therapy treatment\n* Patients who have had chemotherapy (including antibody drug therapy, retinoid therapy, hormonal therapy for cancer) within 3 weeks (2 weeks or five half-lives, whichever is longer for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents), weekly paclitaxel; 6 weeks for nitrosoureas or mitomycin C\n* Patients who have had immunotherapy including monoclonal antibody therapy within 4 weeks\n* Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies\n* Patients who have had a major surgery within 4 weeks\n* Patients with a history of allogeneic organ or stem cell transplant\n* Patients who are receiving any other investigational agents or received any other investigational agents within the past 21 days prior to protocol treatment initiation\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib (ADZ6244 hydrogen sulfate) or DS-8201a (trastuzumab deruxtecan)\n* Current use or anticipated need for alternative, holistic, naturopathic, or botanical formulations used for the purpose of cancer treatment\n* Patients with prior use of immunosuppressive medication within 14 days prior to first study dose, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses less than 10 mg/day of prednisone or equivalent\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patients with a corrected QT interval (QTc) prolongation to \\> 470 ms (females) or \\> 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)\n* Patients with a history of (non-infectious) interstitial lung disease (ILD) that required steroids, presence of ILD that is symptomatic or may interfere with the detection or management of suspected treatment-related pulmonary toxicity, or where suspected ILD cannot be ruled out by imaging at screening. These patients will be excluded because DS-8201a (trastuzumab deruxtecan) is known to increase the risk of developing ILD and pneumonitis\n* Patients with lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months prior to study enrollment, severe asthma, severe chronic obstructive pulmonary disorder (COPD), restrictive lung disease, significant pleural effusion, etc.), and any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), and/or prior pneumonectomy. These patients will be excluded because DS-8201a is known to increase the risk of developing ILD and pneumonitis\n* Patients with gastrointestinal conditions which could impair absorption of selumetinib (AZD6244 hydrogen sulfate) or inability to ingest selumetinib (AZD6244 hydrogen sulfate)\n* Patients with a history of significant retinal pathology (including but not limited to, retinal vein occlusion, retinal detachment, or macular degeneration) or clinically significant ophthalmic abnormalities that may increase the risk of retinal adverse events\n* Active ocular disease requiring systemic therapy or current use of contact lenses that may interfere with ophthalmic evaluations\n* Based on pre-clinical and clinical data, DS-8201a (trastuzumab deruxtecan) and selumetinib (AZD6244 hydrogen sulfate) are associated with ocular toxicity. Patients with clinically significant corneal disease, in the opinion of the investigator, will be excluded from this study\n* Patients who have had chest radiation therapy within 4 weeks (2 weeks for palliative stereotactic body radiation therapy). These patients will be excluded because DS-8201a (trastuzumab deruxtecan) is known to increase the risk of developing pneumonitis\n* Patients with spinal cord compression, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms\n* Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n* Patients that have received a live vaccine within 30 days prior to the first dose of study drug will be excluded. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed\n* Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia or peripheral neuropathy) not yet resolved to grade ≤ 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy). Subjects should no longer be symptomatic nor require treatment with corticosteroids or anticonvulsants and must have recovered from the acute toxic effect of radiotherapy\n* Patients with ongoing muscle disorders or elevated baseline creatine phosphokinase (CPK) levels suggestive of rhabdomyolysis or myopathy\n* Patients currently using high-dose vitamin E supplements exceeding the recommended daily intake (≥ 400 IU/day) or concurrent use of anticoagulants/antiplatelets that may increase bleeding risk, unless clinically indicated and closely monitored\n* Pregnant women are excluded from this study because selumetinib (AZD6244 hydrogen sulfate) is a MEK inhibitor agent with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with selumetinib (AZD6244 hydrogen sulfate) breastfeeding should be discontinued if the mother is treated with selumetinib (AZD6244 hydrogen sulfate). These potential risks also apply to treatment with DS-8201a (trastuzumab deruxtecan)\n* Patients who have received prior systemic anticancer therapy, investigational agents, or radiotherapy without completion of an adequate washout period prior to study treatment initiation defined as at least 14 days or \\> 5 half-lives of the prior agent (whichever is shorter). This applies to therapies with potential overlapping toxicities with DS-8201a (trastuzumab deruxtecan) or selumetinib (AZD6244 hydrogen sulfate) including but not limited to agents associated with pulmonary toxicity, cytopenias, or gastrointestinal toxicity","locations":[{"facility":"UPMC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Occurrence of dose limiting toxicities (DLTs) (dose escalation phase)","HER2 expression status (dose escalation phase)","Overall response rate (phase II)"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Selumetinib for Advanced Pancreatic Ductal Adenocarcinoma","inPlainEnglish":"This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic). Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.","whoItsFor":["Ages 18 Years to any","Review of eligibility criteria by the study principal investigator (PI) is required prior to enrollment","Patients must have histologically or cytologically confirmed adenocarcinoma of the pancreas","Patients must have measurable disease that can fulfill Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria","Patients who have received prior topoisomerase inhibitors including irinotecan and nanoliposomal irinotecan will be eligible for this study","Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of selumetinib (AZD6244 hydrogen sulfate) in combination with DS-8201a (trastuzumab deruxtecan) in patients \\< 18 years of age, children are excluded from this study","Hemoglobin ≥ 9 g/dL (within 14 days of enrollment)","No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment"],"whoShouldSkip":["Patients with prior MEK inhibitor, ERK inhibitor, or HER2-directed therapy treatment","Patients who have had immunotherapy including monoclonal antibody therapy within 4 weeks","Patients who have a history of severe hypersensitivity reactions to other monoclonal antibodies","Patients who have had a major surgery within 4 weeks","Patients with a history of allogeneic organ or stem cell transplant","Patients who are receiving any other investigational agents or received any other investigational agents within the past 21 days prior to protocol treatment initiation","History of allergic reactions attributed to compounds of similar chemical or biologic composition to selumetinib (ADZ6244 hydrogen sulfate) or DS-8201a (trastuzumab deruxtecan)"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Diagnostic Imaging Testing, or Echocardiography Test. The registry lists allocation as na. This phase I/II trial tests the safety, side effects, best dose and how well giving selumetinib with trastuzumab deruxtecan (DS-8201a) works for the treatment of pancreatic ductal adenocarcinoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced), that cannot be removed by surgery (unresectable) or that has spread from where it first started (primary site) to other places in the body (metastatic).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 31 people at Pittsburgh. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.352Z"},{"nctId":"NCT07619534","title":"Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases","officialTitle":"Sample Collection Study to Analyze Cerebral Spinal Fluid as a Biomarker for Brain Metastasis in Metastatic Breast Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nBreast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain. Breast cancer that spreads to the brain is often fatal. Researchers want to know if tumor DNA found in spinal fluid, blood, or tumor tissue can help predict when the cancer will spread to the brain. They want to collect these fluid and tissue samples for research.\n\nObjective:\n\nTo collect spinal fluid and other samples from people with breast cancer that has spread to other parts of the body.\n\nEligibility:\n\nPeople aged 18 years and older with HER2-positive or triple negative breast cancer. The cancer must have spread to other parts of the body but not to the brain.\n\nDesign:\n\nParticipants will be screened. They will have blood tests to assess kidney function. They will have an imaging scan of the brain.\n\nParticipants will come to the NIH clinic to have their samples collected:\n\n* Spinal fluid. A thin needle will be inserted into the lower back to draw out a sample of fluid from the space around the spinal cord. A physical exam and blood tests will be done to make sure it is safe for participants to have this procedure.\n* Blood.\n* Saliva or cheek swabs. They will rub a cotton swab inside of their mouth.\n* Tumor samples. If participants have had samples of tumor tissue (biopsies) collected in the past, leftover tissue may be used for this study.\n\nParticipants will be contacted for follow-up every 6 months for 3 years. They may return once a year to provide further samples.","conditions":["Breast Cancer","Breast Carcinoma","Cancer of the Breast","Malignant Neoplasm of Breast"],"keywords":["Triple Negative Breast Cancer (TNBC)","HER2-Postitive","Metastatic Breast Cancer","Cerebral Spinal Fluid Collection"],"interventions":[{"type":"OTHER","name":"Arm 1"}],"enrollment":139,"startDate":"2026-11-15","completionDate":"2033-07-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n* Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease.\n* Participants must be able to undergo lumbar puncture (LP) and brain MRI.\n* Women age \\>= 18 years\n* Adequate organ function as defined below:\n\n  * Creatinine \\<=1.5 x institutional upper limit of normal (ULN)\n\nOR\n\n--Calculated Creatinine clearance \\>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)\n\n\\- Participants must be able to understand and willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Prior history or current MRI-detected brain metastasis or leptomeningeal disease\n* Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies.\n* Pregnancy","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ann C McCoy, R.N.","phone":"(240) 760-6021","email":"ann.mccoy@nih.gov"},{"name":"Takeo Fujii, M.D.","phone":"(240) 858-3558","email":"takeo.fujii@nih.gov"}],"primaryOutcomes":["Collection of CSF samples"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Arm 1 for Breast Cancer","inPlainEnglish":"Background: Breast cancer is the most common cancer among women. It can often spread to the liver, lungs, bones, or brain.","whoItsFor":["Ages 18 Years to 120 Years","Pathology documentation of histologically confirmed HER2+ BC or TNBC with a history of metastatic disease","Participants must be able to undergo lumbar puncture (LP) and brain MRI","Women age \\>= 18 years","Adequate organ function as defined below:","Creatinine \\<=1.5 x institutional upper limit of normal (ULN)","Calculated Creatinine clearance \\>=40 mL/min/1.73 m2 for individuals with creatinine levels above institutional ULN (using either Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\] equation)"],"whoShouldSkip":["Prior history or current MRI-detected brain metastasis or leptomeningeal disease","Previous history of any invasive malignancies, except for surgically resected local cutaneous malignancies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 139 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.949Z"},{"nctId":"NCT07619547","title":"Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","officialTitle":"Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","sponsorClass":"NIH","summary":"Background:\n\nInflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding. Crohn's disease and ulcerative colitis are the 2 main types of IBD. Researchers want to conduct a natural history study to learn more about whether genetic factors can cause IBD; how immune cells contribute to IBD; and how diet, drugs, and disease affect those cells.\n\nObjective:\n\nTo better understand IBD over time.\n\nEligibility:\n\nAdults aged 18 to 85 years with Crohn's disease, ulcerative colitis, or another IBD. Their healthy relatives are also needed.\n\nDesign:\n\nAffected participants will have clinic visits every 6 months for 3 years.\n\nOnce a year, they will have these procedures:\n\nA physical exam with blood and stool samples.\n\nUltrasound of the abdomen. A wand will be rolled over the skin. It uses sound waves to capture images of the intestines.\n\nMagnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Magnetic fields will capture images of the intestines.\n\nColonoscopy. A long, flexible tube with a video camera will be inserted into the rectum to view the entire colon. Up to 12 tissue samples may be taken.\n\nUpper endoscopy, for those with Crohn's disease. A long, thin tube with a camera will be inserted through the mouth and into the first part of the small intestine. Up to 12 small tissue samples may be taken.\n\nQuestionnaires. Participants will answer questions about their disease and their diet.\n\nMidyear visits will include a physical exam, blood and stool collection, ultrasound, and questionnaires\n\nHealthy relatives will have 1 blood draw for genetic tests.","conditions":["Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis"],"keywords":["Immune System","Inflammation","gastroenterology"],"interventions":[],"enrollment":100,"startDate":"2026-11-05","completionDate":"2036-06-01","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nAffected Participant cohort:\n\n1. Adults 18 - 85 years of age\n2. History of:\n\n   1. a verifiable diagnosis of Crohn's disease, ulcerative colitis, or IBD known to be associated with a co-existing condition (such as CTLA4 deficiency or common variable immune deficiency) and which is supported by characteristic clinical features, radiographic or endoscopic findings, or consistent histopathologic mucosal changes related to chronic inflammation; and/or\n   2. a defined genetic syndrome/mutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD\n3. Presence of a referring community physician who would be able to manage care outside of NIH\n\nUnaffected family member of participant: immediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD\n\n1. Adults 18 - 99 years of age\n2. In good general health\n3. No medical diagnosis of IBD\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Unable or unwilling to provide informed consent\n2. Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kristi C Briggs, M.D.","phone":"(301) 480-2785","email":"kristi.briggs@nih.gov"}],"primaryOutcomes":["To collect longitudinal clinical data and specimens, with the goal of identifying novel biomarkers correlating with disease activity or response to therapy"],"hasResults":false,"conditionSlugs":["als","crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease","inPlainEnglish":"Background: Inflammatory bowel disease (IBD) is a term used to describe disorders that cause long-term inflammation in the digestive tract. Symptoms include stomach pain, diarrhea, and bleeding.","whoItsFor":["Ages 18 Years to 85 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Affected Participant cohort:","Adults 18 - 85 years of age","a defined genetic syndrome/mutation linked to inflammatory bowel disease risk with or without symptoms or findings consistent with IBD","Presence of a referring community physician who would be able to manage care outside of NIH","Unaffected family member of participant: immediate relative to the enrolled participant (mother, father, sibling, or adult child) may be recruited and enrolled to improve interpretation of genetic results or expand the phenotype of the IBD","Adults 18 - 99 years of age"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Evidence of significant medical illnesses that the investigators feel may interfere with study evaluations and procedures"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Bethesda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.884Z"},{"nctId":"NCT07621718","title":"Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","officialTitle":"RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Revolution Medicines, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.","conditions":["Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Pancreatic Adenosquamous Carcinoma"],"keywords":["Pancreatic Cancer","PDAC","Pancreatic Ductal Adenocarcinoma","RAS","KRAS","RAS Mutation","Pancreatic Cancer Metastatic","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenosquamous Carcinoma","Pancreatic Adenocarcinoma"],"interventions":[{"type":"DRUG","name":"Zoldonrasib"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Leucovorin (Calcium Folinate)"},{"type":"DRUG","name":"5-Fluorouracil"},{"type":"DRUG","name":"Irinotecan"},{"type":"DRUG","name":"Gemcitabine (GEM)"},{"type":"DRUG","name":"Nab-paclitaxel"}],"enrollment":670,"startDate":"2026-05-22","completionDate":"2028-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.","locations":[{"facility":"Mayo Clinic Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Arizona Cancer Center-North Campus","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Florida","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Cancer Institute","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Astera Cancer Care","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer University","city":"New Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt-Ingram Cancer Center","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitatsklinikum der PMU Salzburg Landeskrankenhaus","city":"Salzburg","state":"","country":"Austria","status":"RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Careggi","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oncologico Veneto - IRCCS","city":"Padova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radboud UMC","city":"Nijmegen","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Bartholomew's Hospital - Barts Health NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Imperial College Healthcare NHS Foundation Trust - Hammersmith Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Revolution Medicines Study Director","phone":"1-844-2-REVMED","email":"medinfo@revmed.com"}],"primaryOutcomes":["Progression free survival (PFS)","Overall survival (OS)"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","tucson-arizona","new-haven-connecticut","gainesville-florida","jacksonville-florida","tampa-florida","atlanta-georgia","chicago-illinois","baltimore-maryland","boston-massachusetts","rochester-minnesota","east-brunswick-new-jersey","new-brunswick-new-jersey","new-york-new-york","durham-north-carolina","nashville-tennessee","houston-texas","salzburg-austria","florence-italy","padova-italy","nijmegen-netherlands","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Zoldonrasib for Pancreatic Cancer","inPlainEnglish":"This study wants to measure the how well it works of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to dummy treatment (placebo) in combination with chemotherapy.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Histologically or cytologically confirmed pancreatic adenocarcinoma","Diagnosis of metastatic disease ≤ 6 weeks prior to screening","Documented KRAS G12D mutation status","Measurable disease per RECIST v1.1","Adequate organ function (bone marrow, liver, kidney, coagulation)","Able to take oral medications"],"whoShouldSkip":["Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting","Prior systemic RAS-targeted therapy any time prior to randomization","Presence of other known driver mutations with approved targeted therapies","Active or known history of untreated central nervous system metastatic disease","Any conditions that may affect the ability to take or absorb study drug","Major surgery within 28 days prior to randomization"],"whatHappens":"If you join, the listed intervention(s) are Zoldonrasib, Placebo, or Oxaliplatin. The registry lists allocation as randomized. This study wants to measure the how well it works of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to dummy treatment (placebo) in combination with chemotherapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 670 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.451Z"},{"nctId":"NCT07621809","title":"Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden","officialTitle":"A Randomized, Double-blind, Placebo-controlled, 2-arm Multicenter Phase III Study to Assess the Efficacy and Safety of Ianalumab in Participants With Sjogren's Disease With High Symptom Burden (THALASSA)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to demonstrate the efficacy and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.","conditions":["Sjögren´s Disease"],"keywords":["Sjögren´s disease","ianalumab","VAY736","high symptom burden","B cell depleting therapy","BAFF receptor","BAFF-R","ESSDAI","ESSPRI","SSSD","monoclonal antibody","dryness","fatigue","autoimmune disease","sicca syndrome","THALASSA"],"interventions":[{"type":"DRUG","name":"VAY736"},{"type":"DRUG","name":"Placebo"}],"enrollment":570,"startDate":"2026-07-16","completionDate":"2029-08-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher\n* Classification of Sjögren's disease according to ACR/EULAR 2016 criteria.\n* Seropositive for anti-Ro/SSA antibodies at screening\n* SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period\n* Screening ESSDAI biologic and/or hematologic domain \\> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions.\n* Stimulated whole salivary flow (sSF) rate \\> 0.3 mL/min at screening\n* Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period.\n* Predniso(lo)ne ≤ 5 mg/day or equivalent are allowed for up to 16 weeks post-randomization.\n\nExclusion Criteria:\n\n* Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:\n* Systemic sclerosis (SSc)\n* Any other associated connective tissue disease (e.g., lupus nephritis (LN), large vessel vasculitis (LVV), Sharp syndrome (mixed connective tissue disease)) that is active and requires immunosuppressive treatment outside the scope of this trial and would impede on Sjögren's disease organ domain assessments.\n* Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases\n* Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:\n* 36 weeks prior to randomization, or\n* As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening.\n* Prior treatment with ianalumab\n* Prior treatment with any of the following within the given period prior to Screening:\n* Within 5 half-lives prior to Screening: iscalimab (anti-CD 40 mAb), belimumab (anti-BAFF mAb), abatacept (CTLA4-Fc Ig), anti-tumor necrosis factor alpha (TNFα) biologic agents, immunoglobulins (i.v./s.c.), plasmapheresis, any other investigational biologic medicines under investigation for Sjögren's disease\n* Within 4 weeks OR drug-specific 5 half-lives elimination period (if longer than 4 weeks) prior to screening: i.v. or oral cyclophosphamide, mycophenolate mofetil (MMF), methotrexate, azathioprine, i.v. or oral cyclosporine A or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors).\n* History of hypersensitivity to any of the study drugs or their excipients, or to drugs of similar chemical classes (e.g., mAb of IgG1 class) or to any of the constituents of the study drug formulation (sucrose, L-histidine hydrochloride/L-histidine, polysorbate 20).","locations":[{"facility":"Sun Valley Arthritis Center Ltd","city":"Peoria","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Unity Health Rheumatology","city":"Searcy","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medvin Clinical Research","city":"Van Nuys","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Res Of W Florida","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GNP Research","city":"Cooper City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida Inc","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Willow Rheumatology Wellness","city":"Willowbrook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Inst of MI","city":"Saint Clair Shores","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Rheumatology and Bone Disease Associates PA","city":"Voorhees Township","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Lawrence Health System","city":"Potsdam","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"On Site Clinical Solutions Llc","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carolina Arthritis Associates","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"RAO Research LLC","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Tennessee Research Institute","city":"Jackson","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shelby Research LLC","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novel Research LLC","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Care of Texas","city":"Corpus Christi","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precision Comprehensive Clinical Research Solutions","city":"Euless","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Abigail Neiman MD PA","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accurate Clinical Research","city":"League City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TEKTON","city":"Leander","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Northwest PLLC","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative 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Site","city":"Braga","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Košice","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Poprad","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bundang Gu","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Gwangju","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Santander","state":"Cantabria","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bern","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hsinchu","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Swindon","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Change from baseline in SSSD oral dryness score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["peoria-arizona","searcy-arkansas","van-nuys-california","clearwater-florida","cooper-city-florida","tampa-florida","willowbrook-illinois","boston-massachusetts","saint-clair-shores-michigan","voorhees-township-new-jersey","potsdam-new-york","charlotte-north-carolina","wilmington-north-carolina","oklahoma-city-oklahoma","jackson-tennessee","memphis-tennessee","bellaire-texas","corpus-christi-texas","euless-texas","houston-texas","league-city-texas","leander-texas","spokane-washington","maroochydore-australia","graz-austria","s-o-paulo-brazil","sydney-canada","rimouski-canada","sherbrooke-canada","shenzhen-china","nanjing-china","taiyuan-china","chengdu-china","wenzhou-china","ningbo-china","beijing-china","jiujiang-china","bogota-colombia","bogot-colombia","brno-czechia","dijon-france","la-roche-sur-yon-france","le-kremlin-bic-tre-france","le-mans-france","lille-france","montpellier-france","paris-france","saint-priest-en-jarez-france","erlangen-germany","budapest-hungary","kochi-india","nashik-india","jaipur-india","belagavi-india","leeuwarden-netherlands","groningen-netherlands","rotterdam-netherlands","braga-portugal","ko-ice-slovakia","poprad-slovakia","bundang-gu-south-korea","suwon-south-korea","gwangju-south-korea","seoul-south-korea","santander-spain","madrid-spain","seville-spain","bern-switzerland","hsinchu-taiwan","swindon-united-kingdom"],"enrichment":{"headline":"Phase 3: testing VAY736 for Sjögren´s Disease","inPlainEnglish":"This study wants to demonstrate the how well it works and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.","whoItsFor":["Ages 18 Years to any","Male or female participants ≥ 18 years of age or as per country-specific legal adult age, whichever is higher","Classification of Sjögren's disease according to ACR/EULAR 2016 criteria","Seropositive for anti-Ro/SSA antibodies at screening","SSSD oral dryness score ≥ 5 and overall SSSD summary score ≥5 collected over 14 consecutive days during the Screening 2 period","Screening ESSDAI biologic and/or hematologic domain \\> 0 Note: laboratory abnormalities for scoring must be confirmed as associated with Sjögren's disease and not be due to other underlying conditions","Stimulated whole salivary flow (sSF) rate \\> 0.3 mL/min at screening","Participants taking hydroxychloroquine (≤ 400 mg/day) are allowed to continue their medication, and must have been on a stable dose for at least 4 weeks prior to screening, which should be maintained throughout the 52 weeks of the blinded treatment period"],"whoShouldSkip":["Presence of another autoimmune rheumatic disease that is active and constitutes the principal illness, specifically:","Systemic sclerosis (SSc)","Concurrent diagnosis or history of fibromyalgia or overlapping inflammatory diseases","Prior treatment with B-cell-depleting therapy (e.g., rituximab, other anti-CD20 mAb, anti-CD22 mAb, or anti-CD52 mAb) within:","36 weeks prior to randomization, or","As long as B-cell count is less than the lower limit of normal (LLN) or baseline value prior to receipt of previous B-cell-depleting therapy (whichever is lower) at Screening","Prior treatment with ianalumab"],"whatHappens":"If you join, the listed intervention(s) are VAY736, or Placebo. The registry lists allocation as randomized. This study wants to demonstrate the how well it works and safety of ianalumab (VAY736) 300 mg administered subcutaneously (s.c.) monthly for 52 weeks in adult participants with Sjögren's disease who have high symptom burden.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 570 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.951Z"},{"nctId":"NCT07622771","title":"Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial","officialTitle":"Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sun Yat-sen University","sponsorClass":"OTHER","summary":"To explore the efficacy and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer","conditions":["Rectal Cancers"],"keywords":["radiotherapy","immunotherapy","neoadjuvant therapy","rectal cancer"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX"},{"type":"COMBINATION_PRODUCT","name":"Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX"}],"enrollment":84,"startDate":"2026-05-26","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients or their family members agree to participate in the study and sign the informed consent form;\n2. Age 18-75 years, male or female;\n3. Locally advanced rectal adenocarcinoma confirmed by histopathology;\n4. Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;\n5. without intestinal obstruction;\n6. ECOG PS 0-1;\n7. expect survival up to 2 years;\n8. White blood cell count \\> 3.5×109/L；Platelet count ≥ 100×109/L；Hemoglobin ≥ 80 g/L；\n9. ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；\n10. Serum creatinine ≤ 100μmol/l,\n\nExclusion Criteria:\n\n1. With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);\n2. Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;\n3. Severe hypertension poorly controlled with medication;\n4. History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);\n5. Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;\n6. Other active clinically severe infections (NCI-CTCAE Version 5.0);\n7. Preoperative evidence of distant metastasis outside the pelvis;\n8. Cachexia or organ function decompensation.\n9. History of pelvic or abdominal radiotherapy;\n10. Multiple primary colorectal cancers;\n11. Patients with seizures requiring treatment (e.g., corticosteroids or antiepileptic therapy);\n12. History of other malignancies within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;\n13. Drug abuse, or medical, psychological, or social conditions that may interfere with the patient's participation in the study or affect the evaluation of study results;\n14. Active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, enterocolitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism);\n15. Receipt of any anti-infective vaccine (e.g., influenza vaccine, varicella vaccine, etc.) within 4 weeks prior to enrollment;\n16. Comorbidities requiring long-term treatment with immunosuppressive agents, or requiring systemic or local administration of corticosteroids at immunosuppressive doses (dose \\>10 mg/day of prednisone or other glucocorticoids with equivalent efficacy);\n17. Known or suspected hypersensitivity to the investigational drug, or to any medication administered in relation to this study;\n18. Any unstable condition that may jeopardize patient safety or compliance;\n19. Pregnant or lactating women, or women of childbearing potential not using adequate contraception;\n20. Refusal to sign the informed consent form.","locations":[{"facility":"Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chi Zhou","phone":"+86 20 87343920","email":"447486353@qq.com"}],"primaryOutcomes":["CR rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX for Rectal Cancers","inPlainEnglish":"To explore the how well it works and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer","whoItsFor":["Ages 18 Years to 75 Years","Age 18-75 years, male or female;","Locally advanced rectal adenocarcinoma confirmed by histopathology;","Clinical stage cT3-4bN0M0 or cTxN+M0, with or without MRF positive, with or without EMVI positive, expected to R0 resection;","without intestinal obstruction;","expect survival up to 2 years;","White blood cell count \\> 3.5×109/L；Platelet count ≥ 100×109/L；Hemoglobin ≥ 80 g/L；","ALT ≤ 1.5×ULN, AST ≤ 1.5×ULN ；"],"whoShouldSkip":["With inguinal lymph node metastasis or lateral lymph node metastasis (lymph node diameter ≥7 mm, or lymph node morphology and MRI features consistent with typical metastatic lymph nodes);","Arrhythmia requiring antiarrhythmic treatment (except beta-blockers or digoxin), symptomatic coronary artery disease or myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure exceeding NYHA Class II;","Severe hypertension poorly controlled with medication;","History of HIV infection, or active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay);","Active pulmonary tuberculosis (TB), currently receiving anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening;","Other active clinically severe infections (NCI-CTCAE Version 5.0);","Preoperative evidence of distant metastasis outside the pelvis;"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab+NALIRIFOX→Short course radiotherapy →Adalimumab+NALIRIFOX, or Adalimumab+NALIRIFOX→Long course chemoradiotherapy →Adalimumab+NALIRIFOX. The registry lists allocation as randomized. To explore the how well it works and safety of radiotherapy combined with Adebrelimab and NALIRIFOX in patients with pMMR/MSS locally advanced rectal cancer","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 84 people at Guangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.266Z"},{"nctId":"NCT07624305","title":"A Phase III Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With CKD Stage 3b and 4 (BalanceD-CKD)","officialTitle":"A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared With Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Chronic Kidney Disease (Stage 3b and 4)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \\< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.\n\nThis is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.","conditions":["Renal Insufficiency, Chronic"],"keywords":[],"interventions":[{"type":"DRUG","name":"Balcinrenone/dapagliflozin"},{"type":"DRUG","name":"Dapagliflozin"},{"type":"DRUG","name":"Placebo matching Dapagliflozin"},{"type":"DRUG","name":"Placebo matching balcinrenone/dapagliflozin"}],"enrollment":2800,"startDate":"2026-09-01","completionDate":"2030-07-01","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of CKD and at least one of the following:\n\n  1. eGFR ≥ 15 to \\< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory).\n  2. eGFR ≥ 15 to \\< 30 mL/min/1.73 m2 and UACR \\< 30 mg/g (local or central laboratory UACR value).\n* Serum/plasma K+ ≤ 5.0 mmol/L\n* Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.\n\nExclusion Criteria:\n\n* Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation\n* UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening.\n* SBP \\> 180 mmHg or DBP \\> 110 mmHg at screening.\n* SBP \\< 90 mmHg at screening.\n* HbA1c \\> 9% at screening\n* T1DM, except:\n\n  1. For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible.\n  2. For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.\n* Autosomal dominant polycystic kidney disease.\n* Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.\n* Severe hepatic impairment (Child-Pugh Class C).\n* Adrenal insufficiency.\n* Clinically significant acute kidney injury within 12 weeks prior to the screening.\n* New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.\n* Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months) prior to screening.\n* Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.\n* Any use of the following medications and supplements:\n\n  1. MRAs\n  2. Aldosterone analogues\n  3. Aldosterone synthase inhibitors\n  4. Any use of potassium binders within 2 weeks prior to screening. Use is allowed after randomisation.\n  5. Strong or moderate inducers or inhibitors of CYP3A4, prohibited at least one week prior to randomisation","locations":[{"facility":"Research Site","city":"Huntsville","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Surprise","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tempe","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Concord","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Daly City","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research 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3: testing Balcinrenone/dapagliflozin for Renal Insufficiency, Chronic","inPlainEnglish":"This study wants to measure the how well it works, whether it is safe and how hard side effects are to live with of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \\< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC. This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from treatment trials.","whoItsFor":["Ages 18 Years to 99 Years","Diagnosis of CKD and at least one of the following:","eGFR ≥ 15 to \\< 45 mL/min/1.73 m2 AND: UACR ≥ 30 mg/g (central laboratory) or UACR ≥ 100 mg/g (local laboratory ) or UPCR ≥ 200 mg/g (local laboratory)","eGFR ≥ 15 to \\< 30 mL/min/1.73 m2 and UACR \\< 30 mg/g (local or central laboratory UACR value)","Serum/plasma K+ ≤ 5.0 mmol/L","Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening"],"whoShouldSkip":["Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation","UACR ≥ 5000 mg/g or UPCR ≥ 7000 mg/g at screening","SBP \\> 180 mmHg or DBP \\> 110 mmHg at screening","SBP \\< 90 mmHg at screening","HbA1c \\> 9% at screening","For US only: patients with T1DM treated with SGLT2i for at least 4 months prior to screening, without DKA during that period, and who have experience with ketone monitoring are eligible","For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion"],"whatHappens":"If you join, the listed intervention(s) are Balcinrenone/dapagliflozin, Dapagliflozin, or Placebo matching Dapagliflozin. The registry lists allocation as randomized. This study wants to measure the how well it works, whether it is safe and how hard side effects are to live with of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \\< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,800 people at 374 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.971Z"},{"nctId":"NCT07625800","title":"Switch to Ofatumumab and Level of Immunoglobulins","officialTitle":"Switch to Ofatumumab and Level of Immunoglobulins","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Lille","sponsorClass":"OTHER","summary":"This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.\n\nThe primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.","conditions":["Multiple Sclerosis"],"keywords":["Multiple Sclerosis","NIS","Ofatumumab","Kesimpta","Ocrelizumab","IgG","IgM"],"interventions":[{"type":"DRUG","name":"ofatumumab"}],"enrollment":115,"startDate":"2026-10-12","completionDate":"2029-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months.\n2. Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment\\*.\n3. Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study\\*).\n4. Patients agreeing to participate to the study.\n5. Able to provide their non-opposition\n\n   * At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics\n\nExclusion Criteria:\n\n1. Patients with ocrelizumab dose spacing \\> 8 months in the last 18 months before switch\n2. Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch\n3. Ongoing or planned pregnancy","locations":[{"facility":"CHU de Lille","city":"Lille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"PATRICK VERMERSCH, Pr","phone":"06.33.38.32.60","email":"patrick.vermersch@chu-lille.fr"}],"primaryOutcomes":["Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)","Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab","ofatumumab"],"locationSlugs":["lille-france"],"enrichment":{"headline":"Not a traditional drug phase: testing ofatumumab for Multiple Sclerosis","inPlainEnglish":"This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up. The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.","whoItsFor":["Ages 18 Years to 65 Years","Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months","Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment\\*","Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study\\*)","Patients agreeing to participate to the study","At the discretion of the investigator, if a benefit for patients is expected based on their experience and depending on patient's characteristics"],"whoShouldSkip":["Patients with ocrelizumab dose spacing \\> 8 months in the last 18 months before switch","Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch","Ongoing or planned pregnancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 115 people at Lille. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.979Z"},{"nctId":"NCT07626411","title":"Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation","officialTitle":"A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.\n\nThe aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)","conditions":["Atrial Fibrillation (AF)"],"keywords":["Bleeding","Stroke","Systemic embolism","Blood clots"],"interventions":[{"type":"DRUG","name":"REGN7508"},{"type":"DRUG","name":"Apixaban"},{"type":"DRUG","name":"Placebo"}],"enrollment":15364,"startDate":"2026-08-10","completionDate":"2029-09-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol\n2. Meets one of the following:\n\n   1. CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve OR\n   2. CHA2DS2-VA score ≥3 OR\n   3. CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol\n3. Must have an International Normalized Ratio (INR) \\<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)\n\nKey Exclusion Criteria:\n\n1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)\n2. Has known moderate-to-severe mitral stenosis\n3. Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization\n4. Had an ischemic stroke within 2 days prior to randomization\n5. Has persistent, uncontrolled hypertension (per investigator's discretion)\n6. Has estimated Glomerular Filtration Rate (eGFR) \\<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization\n\nNote: Other protocol-defined Inclusion/ Exclusion criteria apply","locations":[{"facility":"Advanced Cardiovascular","city":"Alexander City","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SEC Clinical Research","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Shore Research Institute","city":"Fairhope","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Valley Clinical Trials","city":"Glendale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Scottsdale Clinical Trials","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Cardiology P.A.","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Clinical Trials, Inc","city":"Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mission Cardiovascular Research Institute","city":"Fremont","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Institute of California Heart and Vein Specialists","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Clinical Los Angeles","city":"Inglewood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC at San Diego Cardiovascular Associates","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radin Cardiovascular Medical Group","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valley Clinical Trials, LLC dba Flourish Research","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Heart Specialists","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FOMAT - 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PharmaTex Research","city":"Amarillo","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PanAmerican Clinical Research","city":"Brownsville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Groups Medical","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Houston Area Clinical Trial Consultants, LLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Group Medical, LLC","city":"Missouri City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Permian Research Foundation","city":"Odessa","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tyler Cardiovascular Consultants","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alpine Research TC","city":"Clinton","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carient Heart & Vascular","city":"Manassas","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research","city":"Vienna","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Premiere Clinical Trial Network","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diex Recherche Inc.","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Viacar Recherches Cliniques inc.","city":"Longueuil","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hanaoka Seishu Memorial Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Veritas Hospital","city":"Kawanishi","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Mito Medical Center","city":"Higashiibaraki District","state":"Ibaraki","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Kasumigaura Medical Center","city":"Tsuchiura","state":"Ibaraki","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saiseikai Yokohama-shi Nanbu Hospital","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rakuwakai Otowa Hospital","city":"Kyoto","state":"Kyoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"JA Tsuchiura Kyodo General Hospital","city":"Kanagawa","state":"Yokohama-shi","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism","Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding"],"hasResults":false,"conditionSlugs":["stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["alexander-city-alabama","dothan-alabama","fairhope-alabama","glendale-arizona","scottsdale-arizona","little-rock-arkansas","covina-california","fremont-california","huntington-beach-california","inglewood-california","la-jolla-california","newport-beach-california","northridge-california","pasadena-california","santa-maria-california","ventura-california","west-hills-california","boca-raton-florida","cutler-bay-florida","inverness-florida","medley-florida","new-smyrna-beach-florida","pensacola-florida","saint-augustine-florida","sarasota-florida","winter-park-florida","atlanta-georgia","johns-creek-georgia","hobart-indiana","munster-indiana","west-monroe-louisiana","ft-washington-maryland","foxborough-massachusetts","bloomfield-hills-michigan","farmington-hills-michigan","flint-michigan","staten-island-new-york","concord-north-carolina","high-point-north-carolina","fargo-north-dakota","marion-ohio","maumee-ohio","rapid-city-south-dakota","tullahoma-tennessee","amarillo-texas","brownsville-texas","houston-texas","missouri-city-texas","odessa-texas","tyler-texas","clinton-utah","manassas-virginia","vienna-virginia","hamilton-canada","sherbrooke-canada","longueuil-canada","sapporo-japan","kawanishi-japan","higashiibaraki-district-japan","tsuchiura-japan","yokohama-japan","kyoto-japan","kanagawa-japan"],"enrichment":{"headline":"Phase 3: testing REGN7508 for Atrial Fibrillation (AF)","inPlainEnglish":"This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly.","whoItsFor":["Ages 18 Years to any","Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol","Meets one of the following:","CHA2DS2-VA \\[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\\] score ≥2 and Oral Anticoagulant (OAC) naïve OR","CHA2DS2-VA score ≥3 OR","CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol","Must have an International Normalized Ratio (INR) \\<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)"],"whoShouldSkip":["Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)","Has known moderate-to-severe mitral stenosis","Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization","Had an ischemic stroke within 2 days prior to randomization","Has persistent, uncontrolled hypertension (per investigator's discretion)","Has estimated Glomerular Filtration Rate (eGFR) \\<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization","Note: Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are REGN7508, Apixaban, or Placebo. The registry lists allocation as randomized. This study is researching an experimental drug called REGN7508 (called \"study drug\") and how it compares against another treatment called apixaban.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 15,364 people at 66 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.740Z"},{"nctId":"NCT07628647","title":"Living Well With Brain Cancer: A Group-Based Intervention to Promote Whole-Person Well-Being","officialTitle":"Pilot Study of the Living Well With Brain Cancer Intervention","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are:\n\n* Is it feasible to conduct this program?\n* Does the new group self-management program improve behavioral health outcomes more than in the control group that will not be in a group setting?","conditions":["Brain Cancer"],"keywords":["Brain cancer","Glioblastoma","Astrocytoma","Ependymoma","Oligodendroglioma","Brain tumor","Mental health","Glioma","Quality of life"],"interventions":[{"type":"BEHAVIORAL","name":"Group Self-Management Sessions"},{"type":"OTHER","name":"Educational Materials Only"}],"enrollment":64,"startDate":"2026-06-10","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Currently living in the United States\n* Aged 18 years or older\n* Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)\n* Treating prescribing provider who follows regularly with participant\n\nExclusion Criteria:\n\n* \\<1 month since initial diagnosis and/or \\<1 month since surgical resection\n* Enrollment in hospice\n* Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed\n* Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)\n* Not able to communicate in English at a conversational level","locations":[{"facility":"University of Colorado Anschutz","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals Cleveland Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Services Professional","phone":"303-724-1723","email":"lwbc@cuanschutz.edu"}],"primaryOutcomes":["Change from Baseline of Overall Score from the RAND 36-Item Short Form Survey Instrument (SF-36)"],"hasResults":false,"conditionSlugs":["glioblastoma","als"],"drugSlugs":[],"locationSlugs":["aurora-colorado","cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Group Self-Management Sessions for Brain Cancer","inPlainEnglish":"The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer. The main questions it aims to answer are: * Is it feasible to conduct this program?","whoItsFor":["Ages 18 Years to any","Currently living in the United States","Aged 18 years or older","Confirmed diagnosis of a malignant brain tumor including diffuse gliomas, World Health Organization (WHO) grades II, III, and IV (either by directly sharing their pathology report or confirmation from their prescribing treating provider)","Treating prescribing provider who follows regularly with participant"],"whoShouldSkip":["\\<1 month since initial diagnosis and/or \\<1 month since surgical resection","Enrollment in hospice","Significant physical or cognitive disabilities that prohibit involvement using our clinician's judgement as a self-management expert, with consultation with personal clinician if needed","Currently receiving psychiatric treatment for a serious mental illness (e.g., schizophrenia)","Not able to communicate in English at a conversational level"],"whatHappens":"If you join, the listed intervention(s) are Group Self-Management Sessions, or Educational Materials Only. The registry lists allocation as randomized. The goal of this clinical trial is to learn if the newly designed group self-management program is feasible to conduct and improves mental and behavioral health outcomes compared to a control group in people diagnosed with brain cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 64 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.480Z"},{"nctId":"NCT07629583","title":"To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","officialTitle":"An Open-Label, Multicenter, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cevostamab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).","conditions":["Lupus Erythematosus, Systemic"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cevostamab"},{"type":"DRUG","name":"Tocilizumab"}],"enrollment":46,"startDate":"2026-11-02","completionDate":"2030-03-29","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit\n* Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria\n* Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score\n* Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required\n* Treatment with investigational or non-investigational biologic therapies that directly deplete B cells (e.g., anti-CD20 or anti-CD19 monoclonal antibodies) (or blinded comparators) is prohibited within 6 months or 5 drug elimination half-lives, whichever is longer, prior to screening and during the study\n* Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study\n* Treatment of SLE/LN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study\n* Treatment with CYC within 3 months prior to screening or during the study\n* History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* History of serious recurrent or chronic infection\n* Tuberculosis (TB) infection\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease, which, in the opinion of the investigator, is likely to require treatment with protocol-prohibited therapies\n* Non-SLE related CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease","locations":[{"facility":"Royal Melbourne Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Moinhos de Vento","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital de Clnicas de Porto Alegre","city":"Porto Alegre","state":"Rio Grande do Sul","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital das Clínicas FMRP-USP","city":"Ribeirão Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto","city":"Sao Jose Rio Preto","state":"São Paulo","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pingxiang People's Hospital","city":"Pingxiang","state":"Jiangxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Rangueil","city":"Toulouse","state":"Haute Garonne","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituto Clinico Humanitas","city":"Rozzano","state":"Lombardy","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: GA46280 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants with Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["parkville-australia","porto-alegre-brazil","ribeir-o-preto-brazil","sao-jose-rio-preto-brazil","beijing-china","pingxiang-china","toulouse-france","rozzano-italy","seville-spain"],"enrichment":{"headline":"Phase 1: testing Cevostamab for Lupus Erythematosus, Systemic","inPlainEnglish":"The study will measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria at least 6 months prior to the first screening visit","Active biopsy-proven LN established within 9 months of screening, demonstrating LN per 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria","Diagnosis of active SLE disease, as demonstrated by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score","Inadequate response or intolerance to, in the investigator's judgement, standard of care regimens for active SLE with or without LN"],"whoShouldSkip":["Pregnant or breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required","Treatment with investigational biologic therapies that do not directly deplete B cells (or blinded comparators) is prohibited within 90 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study drug and during the study","Treatment of SLE/LN with non-investigational biologic therapies that do not directly deplete B cells (e.g., belimumab, anifrolumab) is prohibited within 4 weeks prior to screening and during the study","Treatment with CYC within 3 months prior to screening or during the study","History of known or suspected allergic reaction or anaphylactic reaction to cevostamab or its excipients","Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration","Alcohol or substance abuse within the 12 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Cevostamab, or Tocilizumab. The registry lists allocation as na. The study will measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of cevostamab in participants with systemic lupus erythematosus (SLE) with or without active lupus nephritis (LN).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 46 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.271Z"},{"nctId":"NCT07630714","title":"A Study to Investigate Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus","officialTitle":"A Multicenter, Open-Label, Phase II Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Systemic Lupus Erythematosus","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.","conditions":["Systemic Lupus Erythematosus"],"keywords":["Human immunoglobulin (Ig) G1κ monoclonal antibody (mAb) directed against subunit 1 of the type I interferon (IFN) receptor","Accessorized pre-filled syringe","Pharmacokinetics","Pharmacodynamics"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Anifrolumab + APFS"}],"enrollment":24,"startDate":"2026-08-31","completionDate":"2030-09-02","sex":"ALL","minAge":"5 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of SLE.\n* Must be receiving at least one of the following SoC regimens for ≥ 4 weeks: oral glucocorticoids (≤1.0 mg/kg/day or ≤ 40 mg/day prednisone equivalent), antimalarials (hydroxychloroquine, chloroquine, or quinacrine), or a single permitted immunosuppressant (azathioprine, mycophenolate mofetil/mycophenolic acid, methotrexate, mizoribine, or tacrolimus) within specified dose limits.\n* Participant must have moderate to severe active SLE disease defined as Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) ≥ 6 total points.\n* Body weight ≥ 15 kg.\n* Participants must agree to follow study specific contraception requirements as per local regulations.\n\nExclusion Criteria:\n\n* Known diagnosis of an IFN mediated autoinflammatory interferonopathy.\n* History of, or current diagnosis of, clinically significant non-SLE related vasculitides.\n* Active, severe SLE-driven renal disease with significant proteinuria.\n* Active severe or unstable neuropsychiatric SLE including but not limited to aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex.\n* In participants ≥ 11 years of age, a history or evidence of suicidal ideation (severity of 4 \\[active: method and intent, but no plan\\] or 5 \\[active: method, intent, and plan\\]) within the past 6 months; or any suicidal behavior within the past 12 months or recurrent suicidal behavior in the lifetime of the participant based on an assessment with the Columbia suicide severity rating scale (C-SSRS).\n* History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS).\n* History of recurrent or opportunistic infection requiring hospitalization and intravenous (IV) antibiotics.\n* Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection.\n* Active hepatitis B and C infection.\n* Any active or recent herpes zoster (HZ) infection that has not completely resolved within 12 weeks prior to study entry or that emerges between screening and Day 1.\n* Any history of severe or recurrent HZ, including non-cutaneous HZ, herpes encephalitis, ophthalmic herpes, or 2 or more prior HZ episodes.\n* Any cytomegalovirus (CMV) or Epstein Barr virus (EBV) infection that has not completely resolved.\n* History of cancer.\n* Prior receipt of anifrolumab.\n* Prior treatment with directly acting cytotoxic B-cell depleting therapeutics.\n* A known history of allergy or reaction to any component of the study intervention formulation or history of anaphylaxis to any human gamma globulin therapy, human proteins, or monoclonal antibodies (mAbs).","locations":[{"facility":"Research Site","city":"Nedlands","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Parkville","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Southport","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Westmead","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Brussels","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ghent","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leuven","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Liège","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santiago","state":"","country":"Chile","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Haifa","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kfar Saba","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Petah Tikva","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ramat Gan","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tel Aviv","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ginowan-shi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kagoshima","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kanazawa","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Niigata","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Setagaya-ku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Amsterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rotterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Utrecht","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lima","state":"","country":"Peru","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cebu City","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Dagupan","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Davao City","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Manila","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lisbon","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Porto","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Belgrade","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Niš","state":"","country":"Serbia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Maximum observed serum (peak) concentration (Cmax)","Area under the serum concentration-time curve (AUC)","Time to maximum plasma concentration (tmax)","Apparent total body clearance of drug from plasma (CL/F)","Trough drug concentration at steady state (Ctrough,ss)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["nedlands-australia","parkville-australia","southport-australia","westmead-australia","brussels-belgium","ghent-belgium","leuven-belgium","li-ge-belgium","santiago-chile","haifa-israel","kfar-saba-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","ginowan-shi-japan","kagoshima-japan","kanazawa-japan","niigata-japan","setagaya-ku-japan","amsterdam-netherlands","rotterdam-netherlands","utrecht-netherlands","lima-peru","cebu-city-philippines","dagupan-philippines","davao-city-philippines","manila-philippines","lisbon-portugal","porto-portugal","belgrade-serbia","ni-serbia"],"enrichment":{"headline":"Phase 2: Anifrolumab + APFS for Systemic Lupus Erythematosus","inPlainEnglish":"This study wants to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.","whoItsFor":["Ages 5 Years to 17 Years","Participant must have moderate to severe active SLE disease defined as Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) ≥ 6 total points","Body weight ≥ 15 kg","Participants must agree to follow study specific contraception requirements as per local regulations"],"whoShouldSkip":["Known diagnosis of an IFN mediated autoinflammatory interferonopathy","History of, or current diagnosis of, clinically significant non-SLE related vasculitides","Active, severe SLE-driven renal disease with significant proteinuria","History of, or current diagnosis of, catastrophic antiphospholipid syndrome (APS)","History of recurrent or opportunistic infection requiring hospitalization and intravenous (IV) antibiotics","Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus (HIV) infection","Active hepatitis B and C infection"],"whatHappens":"If you join, the listed intervention(s) are Anifrolumab + APFS. The registry lists allocation as randomized. This study wants to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of subcutaneous (SC) anifrolumab in pediatric participants with moderate to severe systemic lupus erythematosus (SLE) while on background standard of care (SoC) therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 24 people at 31 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.283Z"},{"nctId":"NCT07630779","title":"Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients","officialTitle":"A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Beni-Suef University","sponsorClass":"OTHER","summary":"This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.","conditions":["Poly Cystic Ovary Syndrome"],"keywords":["PCOS Myo-Inositol Alpha Lipoic Acid Metformin Insulin Resistance Ovulation"],"interventions":[{"type":"DRUG","name":"Myo-inositol"},{"type":"DIETARY_SUPPLEMENT","name":"Folic Acid"},{"type":"DRUG","name":"Alpha Lipoic Acid"},{"type":"DRUG","name":"Metfomin"}],"enrollment":180,"startDate":"2026-03-10","completionDate":"2026-09-10","sex":"FEMALE","minAge":"21 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged 21 to 40 years\n* Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria\n* Not currently pregnant or lactating\n* No hormonal therapy within the last 3 months\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* \\- History of diabetes mellitus, hypertension, or thyroid disorders\n* History of cardiovascular, renal, or hepatic disease\n* Use of hormonal contraceptives or insulin sensitizers within the last 3 months\n* Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)\n* Non-Egyptian ethnicity","locations":[{"facility":"Faculty of Medicine, Cairo University","city":"Cairo","state":"Cairo Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ahmed A Abdelkader, Lecturer Assistant","phone":"+201050095206","email":"ahmed.abdelkader@hu.edu.eg"},{"name":"Marwa Mohsen Mahmoud, Lecturer","phone":"+201202203223","email":"Marwa.Mohsen@pharm.bsu.edu.eg"}],"primaryOutcomes":["Ovulation Rate","Menstrual Cycle Regularity"],"hasResults":false,"conditionSlugs":["als","pcos"],"drugSlugs":[],"locationSlugs":["cairo-egypt"],"enrichment":{"headline":"Phase 3: testing Myo-inositol for Poly Cystic Ovary Syndrome","inPlainEnglish":"This study evaluates the how well it works of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.","whoItsFor":["Ages 21 Years to 40 Years","Women only","Women aged 21 to 40 years","Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria","Not currently pregnant or lactating","No hormonal therapy within the last 3 months"],"whoShouldSkip":["\\- History of diabetes mellitus, hypertension, or thyroid disorders","History of cardiovascular, renal, or hepatic disease","Use of hormonal contraceptives or insulin sensitizers within the last 3 months","Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)","Non-Egyptian ethnicity"],"whatHappens":"If you join, the listed intervention(s) are Myo-inositol, Folic Acid, or Alpha Lipoic Acid. The registry lists allocation as randomized. This study evaluates the how well it works of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 180 people at Cairo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.796Z"},{"nctId":"NCT07631156","title":"STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure","officialTitle":"STEPwise De-escalation and Optimizing Withdrawal of ARNI and SGLT2i in Normalized Heart Failure (STEP-DOWN HF Trial)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Kyungsub Song","sponsorClass":"OTHER","summary":"This is a multicenter, randomized, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.\n\nEighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng/L will be randomized 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.\n\nThe primary outcome is the change in LVEF at 12 months, with non-inferiority of the withdrawal strategy declared if the LVEF decline is within 5 percentage points of the continuation arm. Secondary outcomes include cardiovascular death, heart failure hospitalization, NT-proBNP, quality of life (KCCQ-12), 6-minute walk distance, and adverse events.\n\nResults from this pilot will inform the design and sample size of a subsequent definitive non-inferiority trial and may provide initial evidence to guide deprescribing decisions in clinical practice.","conditions":["Heart Failure With Reduced Ejection Fraction","Heart Failure","Ventricular Dysfunction, Left"],"keywords":["HFimpEF","ARNI","Sacubitril/Valsartan","SGLT2 Inhibitor","Guideline-Directed Medical Therapy","Reverse Remodeling","Valvular Heart Disease","Ischemic Cardiomyopathy"],"interventions":[{"type":"DRUG","name":"Stepwise Withdrawal of ARNI and SGLT2i"},{"type":"DRUG","name":"Continued Guideline-Directed Medical Therapy"}],"enrollment":80,"startDate":"2026-08-12","completionDate":"2029-06-30","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment\n* N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\<250 ng/L\n* Complete correction of a reversible underlying cause of heart failure: surgical or transcatheter correction of valvular heart disease (mitral regurgitation, aortic stenosis, aortic regurgitation), or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ischemic cardiomyopathy\n* Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and/or beta-blocker may also be used)\n* Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy)\n* For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation\n* For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT\n* Chronic kidney disease stage 4 or higher (eGFR \\<30 mL/min/1.73 m²)\n* Symptomatic hypotension (systolic blood pressure \\<90 mmHg) or symptomatic bradycardia (heart rate \\<50 beats/min)\n* Pregnant, suspected pregnancy, or breastfeeding\n* Terminal malignancy or end-stage organ failure with life expectancy \\<12 months\n* Participation in another clinical trial within 3 months prior to screening\n* Any condition that, in the investigator's judgment, makes the participant unsuitable for the study","locations":[{"facility":"Keimyung University Dongsan Hospital","city":"Daegu","state":"Daegu","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ajou University Hospital","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pusan National University Yangsan Hospital","city":"Yangsan","state":"Gyeongsangnam-do","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"Seoul","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kyungsub Song, Professor","phone":"82)1065564907","email":"chest.songks@gmail.com"},{"name":"In Cheol Kim, Professor","phone":"","email":""}],"primaryOutcomes":["Change in Left Ventricular Ejection Fraction (LVEF) at 12 Months"],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["daegu-south-korea","seongnam-si-south-korea","suwon-south-korea","yangsan-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 4: testing Stepwise Withdrawal of ARNI and SGLT2i for Heart Failure With Reduced Ejection Fraction","inPlainEnglish":"This is a multicenter, randomly assigned, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention. Eighty adult patients (40 per arm) whose left ventricular ejection fraction (LVEF) has recovered to 50% or higher and whose NT-proBNP is ≤ 250 ng/L will be randomly assigned 1:1 to either (1) stepwise withdrawal of ARNI followed by SGLT2i over one month under close echocardiographic monitoring, or (2) continuation of their current guideline-directed medical therapy.","whoItsFor":["Ages 19 Years to any","Adults aged 19 years or older","Prior left ventricular ejection fraction (LVEF) ≤40% before surgery or intervention, with recovery to ≥50% (normalized range) at the time of enrollment","N-terminal pro-B-type natriuretic peptide (NT-proBNP) \\<250 ng/L","Currently receiving both ARNI and SGLT2i for at least 3 months at enrollment (MRA and/or beta-blocker may also be used)","Clinically stable outpatient with no heart failure-related hospitalization within the prior 6 months"],"whoShouldSkip":["Heart failure due to irreversible etiology (e.g., idiopathic dilated cardiomyopathy, toxic cardiomyopathy, genetic cardiomyopathy)","For valvular disease: moderate or greater paravalvular leak, or residual moderate or greater mitral or aortic regurgitation","For ischemic disease: incomplete revascularization or graft occlusion on post-operative coronary CT","Chronic kidney disease stage 4 or higher (eGFR \\<30 mL/min/1.73 m²)","Symptomatic hypotension (systolic blood pressure \\<90 mmHg) or symptomatic bradycardia (heart rate \\<50 beats/min)","Pregnant, suspected pregnancy, or breastfeeding","Terminal malignancy or end-stage organ failure with life expectancy \\<12 months"],"whatHappens":"If you join, the listed intervention(s) are Stepwise Withdrawal of ARNI and SGLT2i, or Continued Guideline-Directed Medical Therapy. The registry lists allocation as randomized. This is a multicenter, randomly assigned, open-label pilot study to evaluate whether stepwise withdrawal of two heart failure medications-angiotensin receptor-neprilysin inhibitor (ARNI) and sodium-glucose cotransporter-2 inhibitor (SGLT2i)-is safe in patients with Heart Failure with improved Ejection Fraction (HFimpEF) whose underlying structural cause (valvular heart disease or ischemic cardiomyopathy) has been completely corrected by surgery or intervention.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 80 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.620Z"},{"nctId":"NCT07631637","title":"Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","officialTitle":"A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study of ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.\n\nIn this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring. The study will compare ALN-CIDEB with placebo to understand how well ALN-CIDEB works to lower the amount of fat in the liver.\n\nThe study is looking at:\n\n* What side effects ALN-CIDEB might cause\n* How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring\n* How the body and the liver change after having ALN-CIDEB, which can help researchers understand why ALN-CIDEB works better for some people than others","conditions":["Metabolic Dysfunction-Associated Steatohepatitis","MASH"],"keywords":["F2 or F3 MASH","Fibrotic MASH","Nonalcoholic Fatty Liver Disease","NAFLD","Metabolic dysfunction-Associated Steatotic Liver Disease","MASLD","Liver Inflammation","Liver Fibrosis","Cirrhosis","Gene silencing","siRNA"],"interventions":[{"type":"DRUG","name":"ALN-CIDEB"},{"type":"DRUG","name":"Placebo"}],"enrollment":360,"startDate":"2026-07-06","completionDate":"2029-01-29","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol\n2. Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol\n3. Has a FibroScan Aspartate aminotransferase (FAST) score \\>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol\n2. Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1\n3. History of liver transplantation, current placement on a liver transplant list, or MELD score \\>12\n4. Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion\n5. Prior, current, or planned future use of a Glucagon-Like Peptide-1 (GLP-1) receptor agonist-based therapy or any medication approved for the treatment of MASH unless used at a generally stable dose and regimen since at least 3 months prior to Screening Visit 1 or the qualifying historical liver biopsy and use is continued throughout the screening period with no change to the dose or regimen anticipated during the treatment period as described in the protocol\n\nNOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply","locations":[{"facility":"Adobe Clinical Research","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Institute for Liver Health II LLC dba Arizona Liver Health","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Del Sol Research Management, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Liver Research Institute","city":"Pasadena","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Clinical Trials","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universal Axon Clinical Research","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southwest General Healthcare Center","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Genoma Research Group, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Med Research of Florida, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indiana University School of Medicine","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansas Medical Clinic","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Marrero","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Geisinger Medical Center","city":"Danville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quality Medical Research - Nashville","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Clinical Research Institute, LLC","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Research Corporation","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Methodist Dallas Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Medical Trials","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pioneer Research Solutions, Inc.","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Research Corporation at The Texas Liver Institute","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Siena Research Network","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion de Investigacion (FDI) Clinical Research","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Newcastle upon Tyne Hospitals NHS Trust","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Percent Change from Baseline in Liver Fat by Magnetic Resonance Imaging-derived Proton Density Fat Fraction (MRI-PDFF)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["tucson-arizona","pasadena-california","rialto-california","doral-florida","fort-myers-florida","miami-florida","indianapolis-indiana","topeka-kansas","marrero-louisiana","metairie-louisiana","danville-pennsylvania","nashville-tennessee","arlington-texas","austin-texas","dallas-texas","georgetown-texas","houston-texas","san-antonio-texas","sugar-land-texas","san-juan-puerto-rico","newcastle-upon-tyne-united-kingdom"],"enrichment":{"headline":"Phase 2: testing ALN-CIDEB for Metabolic Dysfunction-Associated Steatohepatitis","inPlainEnglish":"This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver injury, and liver scarring.","whoItsFor":["Ages 18 Years to 75 Years","A diagnosis of MASH documented in the participant's medical history, or a clinical suspicion of MASH based on non-invasive biomarkers and clinical risk factors, including having a history of 1 or more elements of metabolic syndrome as described in the protocol","Screening percutaneous liver biopsy demonstrating a NAFLD Activity Score (NAS) ≥4 and fibrosis stage F2 or F3 as described in the protocol","Has a FibroScan Aspartate aminotransferase (FAST) score \\>0.35 either at Screening Visit 1 or within approximately 3 months of Screening Visit 1 as described in the protocol"],"whoShouldSkip":["Known chronic liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD), as determined by the investigator as described in the protocol","Prior or current suspected or known drug-induced liver injury within approximately 1 year prior to Screening Visit 1","History of liver transplantation, current placement on a liver transplant list, or MELD score \\>12","Known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion","NOTE: Other Protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ALN-CIDEB, or Placebo. The registry lists allocation as randomized. This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 360 people at 24 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.144Z"},{"nctId":"NCT07631650","title":"Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients","officialTitle":"A Phase 2 Trial of Systemic Administration of Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Patients Undergoing Thyroidectomy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Matthew Spector","sponsorClass":"OTHER","summary":"Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.","conditions":["Head and Neck Disorder","Head and Neck Cancer"],"keywords":["vocal fold immobility","electromyographic (EMG) monitoring","thyroidectomy","intraoperative nerve visualization"],"interventions":[{"type":"DRUG","name":"Bevonescein (ALM 488) Infusion"}],"enrollment":40,"startDate":"2026-11-04","completionDate":"2027-11-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm\n2. Must be a minimum of 18 years old or older\n3. Must be able to give documented informed consent to participate in this study\n4. Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator\n5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry and during the course of the study. An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   o Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n7. Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n1. Previous history of surgery and/or radiation to the head, neck, or shoulder\n2. Abnormal cardiac rhythm not controlled with medication\n3. The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator\n4. Presence or history of any hypersensitivity to bevonescein (or fluorescein) or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects\n5. Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction (MI) or cerebrovascular accident (CVA)\n6. Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study\n7. Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments\n8. The subject has current evidence of renal disease defined as glomerular filtration rate (GFR) \\< 60 mL/min/1.73 m2","locations":[{"facility":"UMPC Hillman Cancer Center","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jennifer Ruth","phone":"412-623-8963","email":"ruthj2@upmc.edu"},{"name":"Mel J Mendez, BS, BS","phone":"878-261-6071","email":"mendezmj@upmc.edu"}],"primaryOutcomes":["Change in Voice Handicap Index (VHI) scores"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["pittsburgh-pennsylvania"],"enrichment":{"headline":"Phase 2: testing Bevonescein (ALM 488) Infusion for Head and Neck Disorder","inPlainEnglish":"Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.","whoItsFor":["Ages 18 Years to any","Scheduled to undergo hemi thyroidectomy or total thyroidectomy for thyroid disease, including neoplasm","Must be a minimum of 18 years old or older","Must be a surgical candidate according to standard of care practices, as determined by the clinical judgement of the investigator","Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:","Willing and able to comply with all study procedures"],"whoShouldSkip":["Previous history of surgery and/or radiation to the head, neck, or shoulder","Abnormal cardiac rhythm not controlled with medication","The patient has a history of drug-related anaphylactic or severe allergic reactions (CTCAE grade 3+), at the discretion of the treating investigator","Presence or history of any hypersensitivity to bevonescein (or fluorescein) or its excipients that, in the judgment of the investigator, places the patient at increased risk for adverse effects","Presence of a concurrent disease or condition that may interfere with study participation including recent (within 6 months of screening) NYHA Class III or IV heart failure, myocardial infarction (MI) or cerebrovascular accident (CVA)","Presence or history of any condition that, in the view of the Investigator, places the patient at high risk of poor treatment compliance or of not completing the study","Use of any Investigational Product or investigational medical device within 30 days prior to surgery date, or requirement for any investigational agent prior to completion of all scheduled study assessments"],"whatHappens":"If you join, the listed intervention(s) are Bevonescein (ALM 488) Infusion. The registry lists allocation as na. Bevonescein (ALM-488) is a novel fluorescein-containing peptide that is intended as a visualization adjunct for the real-time enhanced structural delineation of major nerves during Head and Neck surgery to potentially improve patient outcomes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at Pittsburgh. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.325Z"},{"nctId":"NCT07633158","title":"Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)","officialTitle":"Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"PETRICHOR is a prospective, non-interventional, single-arm, multi-centre study in Germany evaluating real-world clinical and patient-reported outcomes in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), whose disease is inadequately controlled with systemic corticosteroids (SCS) and/or surgery. Eligible participants are newly initiated on subcutaneous tezepelumab in routine clinical practice, in accordance with the European Summary of Product Characteristics (SmPC). Treatment decisions are made jointly by patients and their physicians, independent of study enrollment. No additional diagnostic or monitoring procedures are applied; data are collected using epidemiological methods at baseline and during routine clinical visits for up to 104 weeks.","conditions":["Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)"],"keywords":["Tezepelumab","Chronic rhinosinusitis with nasal polyps (CRSwNP)"],"interventions":[],"enrollment":200,"startDate":"2026-06-10","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"130 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \\- Participant must be 18 years of age or older, at the time of signing the informed consent.\n* \\- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1.\n* \\- Stable standard of care (SoC) treatment with Intranasal corticosteroids (INCS) for CRSwNP for at least 30 days prior to routine care visit 1.\n* \\- Physician decision that participant is eligible for treatment with Tezepelumab according to locally approved CRSwNP label.\n* Participants must be able and willing to read and comprehend written instructions, to collect Patient-reported outcome (PROs) and medication intake via app or alternative mode (paper) and to sign the informed consent document. Use of the mobile app is optional; participants without smartphones will not be excluded. Mode of data capture will be recorded and adjusted for in analyses where relevant.\n* \\- Participants who will be enrolled after index date need to have at least one measurement for SNOT-22 prior (within a maximum of 4 weeks) to index date.\n* \\- -\n\nExclusion Criteria:\n\n* \\- Participants who participate in an observational study that might influence the assessment of the current study (participants can be part of the German National Registry for Chronic rhinosinusitis (GENRE-CRS)); or participate in an interventional clinical trial in the last 3 months.\n* \\- Concurrent biologic therapy for CRSwNP or Asthma except where the last dose was administered ≥ 30 days. Stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment) is allowed.\n* \\- Endoscopic NP surgery within 6 months prior to index date.\n* \\- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant's ability to complete questionnaires or participate in this study.\n* \\- History of documented anaphylactic reactions/hypersensitivity/serious allergic reactions (immune complex disease) following any biologic therapy.\n* \\- Known hypersensitivity to Tezepelumab or any of its excipients.\n* \\- Pregnancy, planned pregnancy or lactation period.\n* \\- -","locations":[{"facility":"Research Site","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bochum","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Braunschweig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Dortmund","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Dresden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Erfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Göppingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hagen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Heilbronn","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jena","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kiel","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Neuenhagen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rosenheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Schweinfurt","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Starnberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tübingen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wiesbaden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Mean change from baseline in sino-nasal symptoms measured by SNOT-22 total score at clinical routine visits."],"hasResults":false,"conditionSlugs":[],"drugSlugs":["tezepelumab"],"locationSlugs":["berlin-germany","bochum-germany","braunschweig-germany","dortmund-germany","dresden-germany","erfurt-germany","g-ppingen-germany","hagen-germany","hamburg-germany","heilbronn-germany","jena-germany","kiel-germany","m-nchen-germany","neuenhagen-germany","rosenheim-germany","schweinfurt-germany","starnberg-germany","t-bingen-germany","wiesbaden-germany"],"enrichment":{"headline":"Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and…","inPlainEnglish":"PETRICHOR is a prospective, non-treatment, single-arm, multi-centre study in Germany evaluating real-world clinical and patient-reported outcomes in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), whose disease is inadequately controlled with systemic corticosteroids (SCS) and/or surgery. Eligible participants are newly initiated on subcutaneous tezepelumab in routine clinical practice, in accordance with the European Summary of Product Characteristics (SmPC).","whoItsFor":["Ages 18 Years to 130 Years","\\- Confirmed diagnosis of CRSwNP for at least 12 months prior to routine care visit 1","\\- Stable standard of care (SoC) treatment with Intranasal corticosteroids (INCS) for CRSwNP for at least 30 days prior to routine care visit 1","\\- Physician decision that participant is eligible for treatment with Tezepelumab according to locally approved CRSwNP label","\\- Participants who will be enrolled after index date need to have at least one measurement for SNOT-22 prior (within a maximum of 4 weeks) to index date"],"whoShouldSkip":["\\- Concurrent biologic therapy for CRSwNP or Asthma except where the last dose was administered ≥ 30 days. Stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment) is allowed","\\- Endoscopic NP surgery within 6 months prior to index date","\\- Condition (acute or chronic) that, in the investigator's opinion, would limit the participant's ability to complete questionnaires or participate in this study","\\- History of documented anaphylactic reactions/hypersensitivity/serious allergic reactions (immune complex disease) following any biologic therapy","\\- Known hypersensitivity to Tezepelumab or any of its excipients","\\- Pregnancy, planned pregnancy or lactation period"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 19 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.858Z"},{"nctId":"NCT07634471","title":"A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)","officialTitle":"A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy. In this study, researchers want to learn if giving a study medicine called MK-1045 and rituximab can treat FL. MK-1045 is a type of treatment called immunotherapy.\n\nThe goals of this study are to learn:\n\n* About the safety of MK-1045 and rituximab, and if people tolerate them when given together\n* If people who receive MK-1045 and rituximab have the cancer go away\n* If people who receive MK-1045 and rituximab live longer without their cancer getting worse compared to those who receive standard treatment (rituximab and chemotherapy)","conditions":["Follicular Lymphoma"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-1045"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"BIOLOGICAL","name":"Rituximab biosimilar"},{"type":"DRUG","name":"Bendamustine"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Vincristine"},{"type":"DRUG","name":"Prednisone"},{"type":"DRUG","name":"Prednisolone"},{"type":"DRUG","name":"Doxorubicin Hydrochloride"}],"enrollment":960,"startDate":"2026-06-22","completionDate":"2032-07-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5.\n* Has radiographically measurable disease per the Lugano Response Criteria.\n* Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated.\n* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART).\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it.\n* If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Has received prior systemic anticancer therapy or radiotherapy for FL.\n* Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL.\n* Has FL that has transformed into a more aggressive type of lymphoma.\n* History or presence of clinically relevant central nervous system (CNS) diseases.\n* Has history of serious cardiovascular and cerebrovascular diseases.\n* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.\n* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n* Has known active CNS lymphoma or involvement.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years.\n* Has active infection requiring systemic therapy.\n* Has chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.","locations":[{"facility":"City of Hope - Duarte Cancer Center ( Site 1301)","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Kentucky ( Site 1303)","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"John Theurer Cancer Center at Hackensack University Medical Center ( Site 1311)","city":"Hackensack","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai ( Site 1325)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Duke Cancer Center Clinic 1B/C Onc/Heme ( Site 1307)","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Cleveland ( Site 1321)","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners ( Site 7000)","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming ( Site 0105)","city":"Ciudad Autonoma de Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Aleman ( Site 0101)","city":"Buenos Aires","state":"Buenos Aires F.D.","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Nuestra Senora del Rosario ( Site 0104)","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Privado Universitario de Córdoba ( Site 0102)","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Box Hill Hospital ( Site 0201)","city":"Box Hill","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biocenter ( Site 0402)","city":"Concepción","state":"Biobio","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Arturo Lopez Perez FALP ( Site 0404)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pontificia Universidad Catolica de Chile ( Site 0407)","city":"Santiago","state":"Region M. de Santiago","country":"Chile","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer hospital ( Site 0501)","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center ( Site 0504)","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 0604)","city":"Tours","state":"Indre-et-Loire","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evangelismos General Hospital of Athens ( Site 1501)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Athens \"Laiko\" ( Site 1502)","city":"Athens","state":"Attica","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center ( Site 0701)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0702)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center ( Site 0704)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)","city":"Rome","state":"Lazio","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"INOC - Istituto Nazionale Oncologico Candiolo ( Site 1602)","city":"Candiolo","state":"Torino","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pratia MCM Krakow ( Site 1702)","city":"Krakow","state":"Lesser Poland Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1701)","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center ( Site 0801)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Català d'Oncologia (ICO) - Badalona ( Site 0904)","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Virgen de la Victoria ( Site 0905)","city":"Málaga","state":"Malaga","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall de Hebron ( Site 0903)","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Gregorio Maranon ( Site 0902)","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Salamanca ( Site 0906)","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital ( Site 1001)","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Medical Foundation-Linkou Branch ( Site 1002)","city":"Taoyuan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hacettepe Universite Hastaneleri ( Site 1110)","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sisli Florence Nightingale Hastanesi ( Site 1112)","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ondokuz Mayıs Universitesi ( Site 1113)","city":"Samsun","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Part 1: Number of Participants Who Experience an Adverse Event (AE)","Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE","Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)","Part 1: Complete Response (CR) Rate","Part 2: Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":[],"locationSlugs":["duarte-california","lexington-kentucky","hackensack-new-jersey","new-york-new-york","durham-north-carolina","cleveland-ohio","nashville-tennessee","ciudad-autonoma-de-buenos-aires-argentina","buenos-aires-argentina","rosario-argentina","c-rdoba-argentina","box-hill-australia","concepci-n-chile","santiago-chile","beijing-china","shanghai-china","tours-france","athens-greece","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","rome-italy","candiolo-italy","krakow-poland","warsaw-poland","seoul-south-korea","badalona-spain","m-laga-spain","barcelona-spain","madrid-spain","salamanca-spain","taipei-taiwan","taoyuan-taiwan","ankara-turkey-t-rkiye","istanbul-turkey-t-rkiye","samsun-turkey-t-rkiye"],"enrichment":{"headline":"Phase 2 / Phase 3: testing MK-1045 for Follicular Lymphoma","inPlainEnglish":"Researchers are looking for new ways to treat follicular lymphoma (FL). A standard (usual) treatment for FL includes a targeted therapy called rituximab and chemotherapy.","whoItsFor":["Ages 18 Years to any","Has biopsy-proven, previously untreated, histologically confirmed cluster of differentiation (CD)19-positive and CD20-positive classical follicular lymphoma (FL), with Ann Arbor Stage II-IV disease and a Follicular Lymphoma International Prognostic Index (FLIPI) score of 2-5","Has radiographically measurable disease per the Lugano Response Criteria","Has provided a newly obtained core or excisional biopsy or archival tissue of a tumor lesion not previously irradiated","If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy (ART)","If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral therapy for at least 4 weeks and will continue it","If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load"],"whoShouldSkip":["Has received prior systemic anticancer therapy or radiotherapy for FL","Has follicular large B-cell lymphoma or any other subtype of FL other than classical FL","Has FL that has transformed into a more aggressive type of lymphoma","History or presence of clinically relevant central nervous system (CNS) diseases","Has history of serious cardiovascular and cerebrovascular diseases","Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention"],"whatHappens":"If you join, the listed intervention(s) are MK-1045, Rituximab, or Rituximab biosimilar. The registry lists allocation as randomized. Researchers are looking for new ways to treat follicular lymphoma (FL).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 960 people at 38 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.153Z"},{"nctId":"NCT07635394","title":"Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome","officialTitle":"Efficacy and Safety of Pregabalin in Patients With Irritable Bowel Syndrome : A Multi-center Prospective Randomized Open Blinded End-point Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Beijing Tiantan Hospital","sponsorClass":"OTHER","summary":"To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).","conditions":["Irritable Bowel Syndrome (IBS)"],"keywords":["Irritable Bowel Syndrome","pregabalin"],"interventions":[{"type":"DRUG","name":"The pregabalin group"},{"type":"DRUG","name":"Routine Treatment"}],"enrollment":258,"startDate":"2026-04-07","completionDate":"2026-04-08","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age range: 18-70 years old;\n2. According to the Rome IV diagnostic criteria for IBS, the screening result is positive;\n3. Mild to moderate IBS patients assessed based on the IBS-SSS.\n\nExclusion Criteria:\n\n1. Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities;\n2. Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months;\n3. Current or intended pregnancy or lactation;\n4. Cognitive impairment;\n5. Recent use of pregabalin (within 30 days) or known allergy to pregabalin;\n6. Concomitant use of medications that may interact with the study drug, mimic its effects, or aggravate expected adverse reactions (including but not limited to rosiglitazone, pioglitazone, opioids, anxiolytics, non opioid analgesics, mexiletine, dextromethorphan, and sedative hypnotics);\n7. Use of IBS specific agents such as alosetron;\n8. Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol).","locations":[{"facility":"Beijing Tiantan Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fang Luo","phone":"+86 13611326978","email":"13611326978@163.com"}],"primaryOutcomes":["The IBS Severity Scoring System (IBS-SSS) and respnse rate"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing The pregabalin group for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"To explore the how well it works of pregabalin for patients with irritable bowel syndrome (IBS).","whoItsFor":["Ages 18 Years to 70 Years","Age range: 18-70 years old;","According to the Rome IV diagnostic criteria for IBS, the screening result is positive;","Mild to moderate IBS patients assessed based on the IBS-SSS"],"whoShouldSkip":["Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities;","Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months;","Current or intended pregnancy or lactation;","Cognitive impairment;","Recent use of pregabalin (within 30 days) or known allergy to pregabalin;","Use of IBS specific agents such as alosetron;","Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol)"],"whatHappens":"If you join, the listed intervention(s) are The pregabalin group, or Routine Treatment. The registry lists allocation as randomized. To explore the how well it works of pregabalin for patients with irritable bowel syndrome (IBS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 258 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.444Z"},{"nctId":"NCT07635563","title":"DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.","officialTitle":"Phase II, Randomized, Double-Blind, Multidose Crossover Clinical Trial to Determine the Safety and Efficacy of IHL-42X in Subjects With Obstructive Sleep Apnea","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Incannex Healthcare Ltd","sponsorClass":"INDUSTRY","summary":"The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea.\n\nThe primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).\n\nThe study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.","conditions":["Obstructive Sleep Apnea (OSA)"],"keywords":["OSA","Obstructive sleep apnea","Obstructive sleep apnoea","CPAP","Cannabinoid","IHL-42X","Incannex","Dronabinol","THC","Aceazolamide","ACZ","AHI","PSG","Polysomnography","PAP","FOS-Q","FOSQ","PROMIS","PGI","ESS","REM","Phase II"],"interventions":[{"type":"DRUG","name":"IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 5 mg dronabinol + 125 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 5 mg dronabinol + 250 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 5 mg dronabinol + 375 mg acetazolamide"},{"type":"DRUG","name":"IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide"},{"type":"DRUG","name":"Placebo: Negative control"}],"enrollment":120,"startDate":"2026-07-21","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nParticipants must satisfy all the following criteria at screening unless otherwise stated:\n\n1. Aged ≥18 and ≤65 years of age at the time of consent.\n2. Two screening PSG findings confirmed on central over-read that both must meet the below criteria:\n\n   1. AHI4 ≥5\n   2. ≤25% central or mixed apneas out of total AHI\n   3. no Cheyne-Stokes respiration\n   4. total sleep time ≥ 4 hours in each PSG\n   5. \\< 30 periodic leg movement disorder arousals per hour.\n3. A difference in AHI4 of ≤15 between screening PSG 1 and screening PSG 2.\n4. A PROMIS-SRI 8a score of \\>16.\n5. Intolerant or non-compliant to PAP, or has refused PAP after physician recommendation. Participants will be identified as intolerant or non-compliant to PAP devices by the following criteria (NB: OSA diagnosis must be entered in participant medical history):\n\n   1. Participants are regarded as PAP-non-compliant if they do not use PAP for ≥ 4 hours for at least 63 nights during consecutive 90-day period based on data collected from the PAP device (e.g., SD storage cards) and/or a cloud-based repository of PAP device data.\n   2. Participants are regarded as PAP-intolerant if they are former PAP users, i.e., a PAP device that they have not used for \\>90 days, have tried PAP and not continued to use it or refusal of PAP after prior positive sleep study or prior refusal of provider recommended sleep study due to unwillingness to consider PAP.\n\n   NB: Participants will have the benefits and risks of PAP explained at screening, including that PAP is standard of care for OSA. Participants also have the option to withdraw from the study at any time if he/she elects to be treated with PAP or other alternative therapy such as an oral appliance or surgery.\n6. Must agree not to take any form of cannabis or cannabinoid with the exception of the IP, or any other illicit or recreational drug while participating in this study.\n7. A female participant of childbearing potential must agree to at least one approved highly effective method of contraception. Approved methods of contraception include the following:\n\n   1. Intra-uterine device in place for at least 3 months prior to Day 1 through to 10 days following the last dose of the study drug.\n   2. Stable hormonal contraceptive which includes oral, intravaginal, intrauterine, transdermal, injectable, or implantable methods of hormonal contraception for at least 3 months prior to Day 1 through to 10 days after the last dose of the study drug.\n\n      NB: Barrier method (condom or diaphragm) is not considered 'highly effective' for the purpose of this study and should be used in combination with one of the approved highly effective methods listed above.\n\n      A female will not be considered of childbearing potential if:\n   3. 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\> 40 mIU/ml.\n   4. Undergone bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months prior to Day 1.\n8. A male participant must agree to use at least 1 approved method of contraception (or as required by local regulations) while engaging in sexual activity from study Day -1 through EOS follow-up and/or up to 10 days following the last administration of the study drug. Male participants must not donate sperm during this same period. Approved methods of contraception include the following:\n\n   1. Barrier method (condom) from date of consent through to 10 days after the final dose of the study drug.\n   2. Surgical sterilization (vasectomy) at least 6 months prior to Day 1 with proof of azoospermia.\n9. Voluntarily written consent to participate in the study and be willing and able to participate in all scheduled visits, treatment plans, tests, and other study procedures according to the protocol.\n\nExclusion Criteria:\n\nParticipants will be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:\n\n1. Body mass index (BMI) \\>40 kg/m2 (men) and \\>42 kg/m2 (women).\n2. Diagnosed obesity hypoventilation syndrome or hypercapnia.\n3. PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period.\n4. Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study.\n5. Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment.\n6. Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months.\n7. Use of benzodiazepines, sedative-hypnotics or stimulants (Anatomical Therapeutic Chemical \\[ATC\\] N06B, N05C, N05BA, N03AE, and N01AF categories) to treat insomnia, OSA, and other sleep disorders, or other disorders that require the drug to be taken prior to sleep.\n8. Use of other prescription medications to treat insomnia.\n9. Pierre Robin, Treacher Collins, or other craniofacial malformation syndrome, or grade ≥3 tonsillar hypertrophy.\n10. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n11. Known allergic or other severe reaction to cannabis products with previous use.\n12. Known allergic reaction to sesame oil.\n13. Known allergic reaction to acetazolamide.\n14. Pregnant or breastfeeding.\n15. Current illicit drug abuse (within the last 6 months prior to screening); \"abuse\" has some subsets that are objective and some that require investigator judgement; questions should be discussed with the medical monitor or with the sponsor\n\n    1. An objective subset includes consumption of substances that are \"illicit\", i.e., not legal per local laws\n    2. Investigator judgement is expected for legally marketed products ingested for other than the approved indication(s)\n    3. Participants who test positive to THC should be screen failed and can be considered for rescreening after a \\>6-week washout period. Participants can only be rescreened once. Positive test results for all other substances shall be reviewed by the investigator and participants shall only be screen failed if the investigator believes the use of the substance may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings.\n16. Severe depression, defined as a score of ≥30 on the Major Depression Inventory (MDI) questionnaire.\n17. Severe anxiety, defined as score of \\>15 on the General Anxiety Disorder-7 (GAD-7) questionnaire.\n18. Any of the following co-morbid conditions (NB: clarification on co-morbidities and inclusion/exclusion criteria may be discussed with the medical monitor and/or sponsor):\n\n    1. Severe psychiatric disorder that might be aggravated or exacerbated by dronabinol's potential to cause anxiety/nervousness, depersonalization, hallucination, etc.\n    2. Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.\n    3. Cardiac dysfunction and/or its treatment that might augment dronabinol's potential to cause tachycardia or vasodilation.\n    4. Marked hepatic dysfunction as defined by elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3 × the upper limit of normal (ULN), that would reduce dronabinol metabolism.\n\n    i. One retest per participant is permitted at the discretion of the investigator; the participant may continue if BOTH repeat transaminase levels are within acceptable range (i.e., less than 3 × ULN).\n\n    e. Current or history of encephalopathy or cirrhosis Child-Pugh category B or C (see Appendix 8) since acetazolamide can increase blood ammonia levels precipitating a bout of hepatic encephalopathy.\n\n    f. Marked renal dysfunction that would reduce acetazolamide excretion, including eGFR \\<60 mL/min/1.73 m2, as determined using the National Kidney Foundation calculator (https://www.kidney.org/professionals /kdoqi/gfr\\_calculator) and instructions in Appendix 9.\n\n    g. Hypokalemia (low blood potassium), hyponatremia (low blood sodium), hyperchloremic acidosis, and/or adrenal insufficiency that might be aggravated or exacerbated by acetazolamide's activity as a carbonic anhydrase inhibitor.\n19. Known CYP2C9 poor metabolizers (NB: this is based on medical history and does not need to be tested genetically).\n20. Other ongoing condition(s) that the investigator considers may be clinically significant with regards to the participant's safe participation in this study or may confound this study's findings; any consideration should be discussed with the medical monitor or with the sponsor (such as known alcohol abuse).\n21. Shift workers whose shift pattern has the potential to disrupt sleep patterns.\n22. Participation in any other interventional studies involving investigational or marketed products within 30 days or 5.5 half-lives, whichever is longer, prior to screening.","locations":[{"facility":"Exalt Clinical Research","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Teradan Clinical Trials LLC","city":"Brandon","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare - Jacksonville","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palm Beach Research Center","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Marrero","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Rockville","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTI Clinical Research Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Intrepid Research","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Anderson","city":"Anderson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare - Memphis","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sleep Therapy & Research Center","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mark Bleackley","phone":"+61 2 9634 4508","email":"mark@incannex.com.au"},{"name":"Pia Kroner","phone":"+61 (2) 9634 4508","email":"pia@incannex.com.au"}],"primaryOutcomes":["Change in AHI4 at the end of each treatment period compared to baseline"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["chula-vista-california","brandon-florida","jacksonville-florida","orlando-florida","west-palm-beach-florida","marrero-louisiana","rockville-maryland","cincinnati-ohio","anderson-south-carolina","memphis-tennessee","dallas-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 2: testing IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide for Obstructive Sleep Apnea (OSA)","inPlainEnglish":"The goal of this randomly assigned, neither you nor the study doctors know who gets the real treatment, multi-dose crossover clinical trial is to determine the safety and how well it works of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days).","whoItsFor":["Ages 18 Years to 65 Years","Participants must satisfy all the following criteria at screening unless otherwise stated:","Aged ≥18 and ≤65 years of age at the time of consent","Two screening PSG findings confirmed on central over-read that both must meet the below criteria:","≤25% central or mixed apneas out of total AHI","no Cheyne-Stokes respiration","total sleep time ≥ 4 hours in each PSG","\\< 30 periodic leg movement disorder arousals per hour"],"whoShouldSkip":["you would be excluded from the study if they satisfy any of the following criteria at screening, unless otherwise stated:","Body mass index (body-mass index (BMI)) \\>40 kg/m2 (men) and \\>42 kg/m2 (women)","Diagnosed obesity hypoventilation syndrome or hypercapnia","PAP-compliant, defined by use of PAP for ≥4 hours for at least 63 nights during the consecutive 90-day period","Current use of custom-made oral appliances (mandibular advancement device, tongue retaining device, or mouth guard) or hypoglossal nerve stimulation devices. Devices must not be used for the duration of the study","Maxillomandibular advancement, upper airway, or bariatric surgery within the last 6 months prior to first administration of the study drug; or participants who are planning surgical treatment","Have commenced glucagon-like peptide-1 receptor agonist therapy within the last 6 months"],"whatHappens":"If you join, the listed intervention(s) are IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide, IHL-42X: 5 mg dronabinol + 125 mg acetazolamide, or IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide. The registry lists allocation as randomized. The goal of this randomly assigned, neither you nor the study doctors know who gets the real treatment, multi-dose crossover clinical trial is to determine the safety and how well it works of IHL-42X in subjects with obstructive sleep apnea.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 13 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.951Z"},{"nctId":"NCT07636785","title":"A Phase 1 and 2 Study of VMD-102 in Hepatocellular Carcinoma and Other Solid Tumors","officialTitle":"A Phase 1 and 2 First-in-human, Open-label, Multicenter Study to Assess the Safety, Tolerability and Preliminary Efficacy of VMD-102 in Participants With Hepatocellular Carcinoma and Other Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"VM Discovery, Inc.","sponsorClass":"INDUSTRY","summary":"This study is to evaluate the safety and tolerability to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor efficacy (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.\n\nVMD-102 will be the first selective PKC epsilon (PKCε or PKCe) kinase inhibitor to enter human clinical testing. Preclinical VMD-102 anti-tumor activities in mouse liver/HCC tumor models and preclinical toxicology and pharmacology studies support this study.","conditions":["Hepatocellular Carcinoma (HCC)","Metastatic Uveal Melanoma","Renal Cell Carcinoma (RCC)","Nonsmall Cell Lung Cancer","Colorectal Cancer (CRC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"VMD-102"}],"enrollment":111,"startDate":"2026-07-16","completionDate":"2031-05","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histological or cytological or radiological diagnosis of advanced (unresectable and/or metastatic) HCC, MUM, RCC, NSCLC and CRC that is not responsive to standard of care (SOC), had progressed following SOC, is intolerant to SOC, or for whom the SOC is not considered appropriate by the investigator.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1.\n* Has at least one measurable target lesion according to RECIST v1.1 \\[Response Evaluation Criteria In Solid Tumors\\], or mRECIST \\[modified RECIST\\] for unresectable HCC participants, and either (a). has not been previously treated with local therapy (e.g., radiation therapy, hepatic arterial embolization, radiofrequency ablation, and percutaneous interventional therapy), or (b). if the target lesion was within the field of local therapy, the lesion has shown an increase in size of 25% or greater following local therapy.\n* Adequate organ function evidenced by:\n\nHematology\n\n* Hemoglobin ≥ 9 g/dL (SI Units: 90 g/L) (post-transfusion if transfusion-dependent)\n* Platelet count ≥ 60000/mm3 (60 x109/L) without support(transfusion) within 7 days of testing\n* Absolute neutrophil count (ANC) ≥ 1500/mm3 (1.5x109/L) Chemistry\n* Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\<30% of the TBIL)\n* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)\n* AST and/or ALT 1 ≤ 3 x ULN (participants without known liver disease or liver metastases)\n* Calculated creatinine clearance or 24h urine creatinine clearance ≥50 mL/min using Cockroft-Gault formula.\n* Serum creatinine ≤ 1.5x ULN\n\nCoagulation (unless taking an anti-coagulant):\n\n* Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for participants receiving therapeutic anticoagulants)\n* International normalized ratio (INR) ≤ 1.5 unless the participant is receiving anticoagulant therapy as long as the participant is within therapeutic range of intended use of anticoagulants\n* Albumin ≥2.8g/d/L.\n\n  * For HCC participants: the diagnosis must be made based on American Association for the Study of Liver Diseases (AASLD) Guidelines with confirmed advanced (unresectable) HCC staged by Barcelona Clinic Liver cancer criteria (BCLC). Cirrhosis will be staged by Child-Pugh score, and such a score ≤ 6 will be eligible for Phase 1 and ≤7 for Phase 2.\n  * Participants must either have available archival tumor tissue samples, or consent to fresh tumor tissue sampling prior to the first dose unless the biopsy is not safe or not feasible per investigator assessment and with medical monitor approval.\n  * Women of childbearing potential (WOCBP) must have a negative pregnancy test prior to enrolment and agree to use a highly effective and acceptable method of contraception from the time of informed consent (or screening) until 6 months after the last dose of investigational agent.\n  * Male participants who are sexually active with a female partner of childbearing potential must agree to use a condom with spermicide from first dose of investigational agent until 6 months after the last dose, and refrain from sperm donation during that period. Abstinence from heterosexual intercourse is an acceptable method only if the participant's usual lifestyle already includes abstinence.\n  * Participant has a life expectancy of ≥3 months.\n  * No history of liver transplantation.\n  * Ability to swallow and absorb an orally self-administered medication in tablet form.\n  * Have completed any prior chemotherapy, monoclonal antibody or immunotherapy (e.g., tumor vaccine, cytokine, or growth factor given to control the cancer) at least 4 weeks or 5 half-lives (whichever is shorter) before study drug administration. Exceptions to these prior therapy timeframes are possible, on a case by case basis, following discussion and mutual agreement between Investigator and Sponsor.\n  * Adverse effects related to prior anticancer therapies must have either returned to baseline or resolved to Grade 0 or 1. Some toxicities with higher grades such as alopecia, immunotherapy-induced hypothyroidism or adrenal insufficiency or panhypopituitarism requiring stable doses of hormone replacement therapy or rash from prior therapy may be permitted with medical monitor approval.\n\nExclusion Criteria:\n\n* Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer).\n* Currently pregnant, nursing, or planning to become pregnant during the course of study.\n* The Fridericia Corrected QT (QTcF) interval ≥ 480 msec.\n* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system (Section 14.8); or presence of clinically significant and uncontrolled cardiac disease, as assessed by the investigator. Such as but not limited to: symptomatic congestive heart failure, unstable angina, cardiac arrhythmia.\n* Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug.\n* Psychological, familial, sociological, geographical or other concurrent conditions that would interfere with safety evaluation, limit the participant's ability to follow the procedures in the protocol or otherwise jeopardize compliance with the protocol. Participants with uncontrolled major depression, bipolar disorder, or severe anxiety disorder are excluded.\n* Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection).\n* Participants have long-term unhealed wounds or fractures.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage.\n* Any current medical conditions, including impairment of GI function or GI disease, which would alter the absorption, distribution, metabolism or excretion of VMD-102 including but not limited to:\n\n  * Severe uncontrolled nausea or vomiting.\n  * Severe uncontrolled diarrhea or ongoing active diarrhea requires medications (e.g. bile acid sequestrant, loperamide).\n  * A history of short bowel syndrome; irritable bowel syndrome with diarrheal signs/symptoms or require medications.\n  * Clinically diagnosed malabsorption secondary to bowel resection.\n  * Active Ulcerative colitis or Crohn's disease requiring medication for control.\n  * Surgical procedures of the GI tract impacting the drug absorption such as but not limited to small bowel resection and gastric bypass.\n* Unstable central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least one cycle prior to the first dose and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are on stable doses of steroids for at least one cycle prior to the first dose.\n* Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC or HCC due to cirrhosis caused from autoimmune-associated hepatitis.\n* Hepatitis B surface antigen (HBsAg) positive with detectable the hepatitis B virus load (HBV DNA) \\>100 IU/mL. Participants on active HBV therapy with viral loads \\<100 IU/mL should stay on the same therapy throughout study intervention and at least 12 weeks after the study is over. Participants cannot be actively co-infected with hepatitis C virus (HCV; HCV RNA detectable) or hepatitis delta virus (HDV; HDV RNA detectable).\n* Positive HBsAg, with or without detectable HBV DNA, if there is evidence in the medical history of an advanced stage of cirrhosis ( Child-Pugh B) or history of decompensated chronic liver disease\n* HCV antibody (HCVAb) positive and HCV viral load (HCV RNA) detectable. Previous HCVAb positive with HCV RNA undetectable due to treatment (DAAs or interferon) is allowed but the treated participants must have completed their treatment at least 12 weeks prior to starting study intervention and HCV RNA must be documented at below the limit of quantification.\n* History of allogeneic tissue/organ transplantation (including bone marrow, stem cell, liver, or kidney transplants), except those that do not require immunosuppressive therapy (e.g., corneal or hair transplants).\n* Coronavirus disease 2019 (COVID-19) or any live attenuated vaccine within 4 weeks of study entry.\n* Participants with active alcohol and/or substances abuse, Phosphatidylethanol (Peth) must be \\<50 ng/mL).\n* Concurrent secondary malignancy other than that being treated in this study. Exceptions to this exclusion include malignancies treated curatively and have not recurred within 2 years prior to study entry or tumors treated with curative intent that have expected cure rates of \\>90% such as but not limited to: basal cell and squamous skin cancer and completely resected carcinoma in situs.\n* Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage. Exception may be possible, on a case by case basis, e.g. if no more than one paracentesis in a month and a drain is pre-placed for the participant to drain, following discussion and mutual agreement between Investigator and Sponsor\n* Participants have long-term unhealed wounds or fractures.\n* Participants receiving known potent P-glycoprotein (P-gp) efflux transporter inhibitors that cannot be discontinued 3 days prior to the start of study treatment and during the course of the Phase 1 study.\n* Known immediate or delayed hypersensitivity reaction or idiosyncrasy to the study drug, or excipients.\n* Known history of uncontrolled human immunodeficiency virus (HIV) infection.\n* Any other condition that, in the opinion of the Investigator or the medical monitor, could increase the risk to the participant, interfere with study participation, or affect the proper interpretation of study results and objectives. Such conditions may include but are not limited to, active infections, uncontrolled diabetes, psychiatric illness, social situations, and concomitant therapies.","locations":[{"facility":"HonorHealth Research Institute (#600)","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Angeles Clinic and Research Institute (#601)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jay Wu, PhD","phone":"+1-510-661-6770 ext. 101","email":"OM@VMDiscovery.com"}],"primaryOutcomes":["Number and severity of treatment-emergent adverse events (TEAE) (Phase 1)","To determine the recommended Phase 2 dose (RP2D) for VMD-102 (Phase 1)","Progression-Free Survival (PFS) (Phase 2)"],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer","melanoma","kidney-cancer","liver-cancer","als"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","los-angeles-california"],"enrichment":{"headline":"Phase 1 / Phase 2: testing VMD-102 for Hepatocellular Carcinoma (HCC)","inPlainEnglish":"This study is to measure the whether it is safe and how hard side effects are to live with to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor how well it works (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC). The pharmacokinetics (PK), preliminary anti-tumor activity, and potential biomarkers of VMD-102 will also be assessed.","whoItsFor":["Ages 18 Years to 75 Years","Eastern Cooperative Oncology Group (ECOG) Performance Status 0, or 1","Adequate organ function evidenced by:","Hemoglobin ≥ 9 g/dL (SI Units: 90 g/L) (post-transfusion if transfusion-dependent)","Platelet count ≥ 60000/mm3 (60 x109/L) without support(transfusion) within 7 days of testing","Absolute neutrophil count (ANC) ≥ 1500/mm3 (1.5x109/L) Chemistry","Total bilirubin (TBIL) ≤ 2.0 x upper limit of normal (ULN). (For participants with Gilbert's syndrome, TBIL ≤3.0 x ULN provided that direct bilirubin DBIL) is \\<30% of the TBIL)","Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) 1 ≤ 5 x U LN (participants with advanced HCC or liver metastases)"],"whoShouldSkip":["Received anticancer therapy with radiation, immunotherapy, a biologic, surgery and/or tumor embolization within the past 2 weeks or 5 half-lives (whichever is longer)","Currently pregnant, nursing, or planning to become pregnant during the course of study","The Fridericia Corrected QT (QTcF) interval ≥ 480 msec","Unstable or uncompensated respiratory, hepatic, renal, or cardiac disease that would compromise the participant's safety or interfere with assessment of the drug","Participants have multiple factors that affect their oral medication (such as inability to swallow and intestinal obstruction or resection)","Participants have long-term unhealed wounds or fractures","Participants have uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage"],"whatHappens":"If you join, the listed intervention(s) are VMD-102. The registry lists allocation as na. This study is to measure the whether it is safe and how hard side effects are to live with to determine (i) the recommended Phase 2 dose (RP2D) of VMD-102 (Phase 1), and (ii) preliminary anti-tumor how well it works (Phase 2), in participants with advanced HCC, metastatic uveal melanoma (MUM), renal cell carcinoma (RCC), non-small cell lung cancer (NSCLC), and colorectal cancer (CRC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 111 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.818Z"},{"nctId":"NCT07637669","title":"Olfactory Function and Model-Based Behavior in People Living With HIV and SUD","officialTitle":"Olfactory Function and Model-based Behavior in People Living With HIV and SUD","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute on Drug Abuse (NIDA)","sponsorClass":"NIH","summary":"Background:\n\nHuman immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell. HIV infection is common in people with substance use disorder (SUD). SUD also affects thinking ability. Researchers want to learn more about the connection between the sense of smell and decision-making ability in people with HIV, SUD, or both.\n\nObjective:\n\nTo test the sense of smell in people with HIV and/or SUD and how they make choices based on odors.\n\nEligibility:\n\nPeople aged 18 to 65 years with any of these: (1) HIV, (2) SUD, (3) both HIV and SUD, or (4) neither SUD nor HIV.\n\nDesign:\n\nParticipants will have 2 visits. Each visit will last 3 to 5 hours.\n\nIn visit 1, participants will have a blood draw and a saliva swab. They will answer questions about their health, sleep habits, food intake, and substance use. They will have smell tests:\n\nThey will smell scented sticks and answer questions about them. They will be blindfolded for some tests.\n\nThey will perform tasks on a computer. They will look at pictures and smell pleasant food odors, such as chocolate cake or pizza. Smells will be delivered using a nasal mask. Their sniffing and breathing will be measured. They may also be exposed to odor-free air. They will eat food that corresponds to one of the food odors they smelled.\n\nIn visit 2, participants will do a saliva swab and a different computer task that involves odors. They will also have tests of their attention and memory. Participants may opt to have an imaging scan of the brain.","conditions":["HIV","Substance Use Disorder"],"keywords":["HIV","Substance Use Disorder","Olfaction","Decision Making"],"interventions":[],"enrollment":120,"startDate":"2026-11-15","completionDate":"2031-06-27","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\nFor all participants:\n\n1. Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97.\n2. Ability of subject to understand and the willingness to sign a written informed consent document.\n\nFor participants in the HIV+ and SUD+ and HIV+ and SUD- groups:\n\n1\\. HIV positive.\n\nFor participants in the HIV+ and SUD+ and HIV- \\& SUD+ groups:\n\n1\\. Current history (past 12 months) of Substance Use Disorder (SUD) or medical treatment for SUD, other than Alcohol Use Disorder (AUD), mild Cannabis Use Disorder (CUD), or Tobacco Use Disorder (TUD). Non-medical treatments for SUD will be evaluated on a case-by-case-basis by the MAI.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nFor all participants:\n\n1. History of neurological illnesses or neurosurgery including but not limited to cerebrovascular accident, Parkinson disease, Alzheimer disease, Huntington disease, central nervous system (CNS) tumor, significant head trauma with sequelae, multiple sclerosis or other demyelinating diseases, epilepsy, movement disorders. The MAI will also retain discretion to exclude based on a history of a neurological illness or trauma that may compromise data integrity.\n2. History of current (past 3 months) symptomatic, more than mild DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI.\n3. Candidates who recently (12 hours prior to a study visit) used medications and/or substances that are psychoactive or otherwise affect alertness will have to pass a clinical assessment for intoxication on the day of the study visit. Based on participant preferences and MAI/PI judgment, participants who fail the clinical assessment for intoxication will either be withdrawn or rescheduled.\n4. History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion.\n5. Uncorrected impairments in visual acuity severe enough to affect task performance.\n6. Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English.\n7. Pregnancy.\n8. Any other condition that in the judgment of the investigators is incompatible with participation.\n\nFor participants in the HIV+ and SUD- and HIV- and SUD- groups:\n\n1. History (past 5 years) of SUD, excluding tobacco use disorder (TUD).\n2. Pattern of alcohol and drug use in the past 12 months that is indicative of harmful use, loss of control over use, or physical dependence.\n3. Daily alcohol or drug use (excluding caffeine and nicotine) for at least 4 continuous weeks in the past 12 months.\n\nFor participants in the HIV- and SUD+ and HIV- and SUD- groups:\n\n1\\. HIV positive.\n\nFor participants in the HIV- \\& SUD- group:\n\n1\\. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.\n\nFor the Optional MRI Segment:\n\n1\\. Unable to undergo MRI scanning due to certain metallic or magnetic devices or implants in the body, or claustrophobia.","locations":[{"facility":"National Institute on Drug Abuse","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"NIDA IRP Screening Team","phone":"(800) 535-8254","email":"researchstudies@nida.nih.gov"},{"name":"Thorsten Kahnt, Ph.D.","phone":"(667) 312-5175","email":"thorsten.kahnt@nih.gov"}],"primaryOutcomes":["Olfactory function","Model-based decision making"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Olfactory Function and Model-Based Behavior in People Living With HIV and SUD","inPlainEnglish":"Background: Human immunodeficiency virus (HIV) infection can affect areas of the brain that control thinking ability. These same areas of the brain also control the sense of smell.","whoItsFor":["Ages 18 Years to 65 Years","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","For all participants:","Aged 18-65 years old. Justification: prevalence of olfactory impairments increases with age; after age 53, the prevalence is 24.5 percent, increasing to 62.5 percent in people ages 80-97","For participants in the HIV+ and SUD+ and HIV+ and SUD- groups:","For participants in the HIV+ and SUD+ and HIV- \\& SUD+ groups:"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","For all participants:","History of current (past 3 months) symptomatic, more than mild DSM-5 psychiatric disorder including major affective disorder, obsessive-compulsive disorder, schizophrenia, or posttraumatic stress disorder, excluding SUD. This will be determined at the discretion of the MAI","History of clinically significant anaphylaxis, e.g., due to severe asthma or food and nonfood allergies (e.g., latex, detergents, soap, etc.). The MAI will retain discretion to exclude a participant based on this criterion","Uncorrected impairments in visual acuity severe enough to affect task performance","Non-English speaking. Justification: The data integrity of some of the behavioral tasks used in this study would be compromised as they have only been validated in English","Any other condition that in the judgment of the investigators is incompatible with participation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.526Z"},{"nctId":"NCT07637942","title":"Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy","officialTitle":"Phase IV Study of the Pharmacokinetics of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Women With HIV in the United States","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"International Maternal Pediatric Adolescent AIDS Clinical Trials Group","sponsorClass":"NETWORK","summary":"Phase IV, multi-site, open-label, non-randomized study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.","conditions":["HIV -1 Infection"],"keywords":["HIV","Pregnancy","CAB LA + RPV LA"],"interventions":[{"type":"DRUG","name":"Every 4-week long-acting injectable cabotegravir and rilpivirine"},{"type":"DRUG","name":"Every 4-week long-acting injectable cabotegravir and rilpivirine"}],"enrollment":40,"startDate":"2026-10-01","completionDate":"2028-04-22","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to provide written informed consent for study participation for self and infant\n* At screening, age 18 years or older\n* Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry\n* At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up\n* Was diagnosed with HIV prior to the current pregnancy\n* Has a documented plasma HIV RNA result less than 50 copies/mL from a specimen collected within 28 days prior to entry\n* Has the following laboratory test results from a specimen collected within 28 days prior to entry (1) Grade 2 or lower platelets (greater than or equal to 50,000 cells/mm3 or greater than or equal to 50.00 x 109 cells/L); (2) Grade 1 or lower ALT (less than 2.5 x upper limit of normal; (3) Grade 1 or lower aspartate aminotransferase (AST)\n* Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation\n\nExclusion Criteria:\n\n* History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)\n* Has any of the following (1) HIV Subtype A6; (2) History of hypersensitivity reaction (HSR), known or suspected allergy to drugs under study, or any other contraindication to CAB or RPV; (3) Current contraindication to IM injection such as a current inflammatory skin condition that compromises the safety of IM injections or a dermatological condition which may interfere with the interpretation of ISRs; (4) Current use or anticipated need of therapeutic anticoagulation; (5) History of known or suspected bleeding disorder; (6) Current severe hepatic impairment (Class C) as determined by Child-Pugh classification; (7) History of suicidal ideation or attempt within six months of entry; (8) History of unstable or poorly controlled seizure disorder; (9) Current tuberculosis infection; (10) Current cervical intraepithelial neoplasia (CIN) 2 or 3, or malignancy other than Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma\n* Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy\n* Had any of the following in a previous pregnancy: (1) Eclampsia/Hemolysis, Elevated Liver enzymes and Low Platelets (HELLP) syndrome; (2) Intrauterine fetal demise (EGA greater than 20 weeks) without known nonrecurrent etiology; (3) Spontaneous very preterm delivery (less than 32 weeks); (4) Very LBW (less than 1500 g); (5) Cervical or abdominal cerclage due to cervical incompetence\n* Receipt of any prohibited medication within seven days prior to entry\n* Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV\n* Receipt of an investigational agent or chemotherapy within 30 days prior to study entry\n* Adult-participant or fetus has any condition, such as uncontrolled diabetes, hypertension, or other comorbidities, that, in the opinion of the site investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives","locations":[{"facility":"Site 4601, University of California, UC San Diego CRS","city":"La Jolla","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 5048, University of Southern California","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 5052, University of Colorado","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 5030, Emory University School of Medicine","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 4001, Lurie Children's Hospital of Chicago CRS","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 5092, Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 5013, Jacobi Medical Center Bronx","city":"The Bronx","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 6201, University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Site 6501, St Jude Children's Research Hospital","city":"Memphis","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Site 5128, Baylor College of Medicine/Texas Children's Hospital","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lisa Levy","phone":"2028848480","email":"LLEVY@FHI360.ORG"}],"primaryOutcomes":["Population PK: geometric mean clearance of CAB and RPV in second trimester, third trimester, and postpartum derived from a population PK model","Geometric mean pharmacokinetic trough of CAB and RPV from every 4 week (Q4W) CAB LA and RPV LA measured every 4 weeks in plasma in second trimester, third trimester, and postpartum"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["la-jolla-california","los-angeles-california","aurora-colorado","atlanta-georgia","chicago-illinois","baltimore-maryland","the-bronx-new-york","philadelphia-pennsylvania","memphis-tennessee","houston-texas"],"enrichment":{"headline":"Phase 4: testing Every 4-week long-acting injectable cabotegravir and rilpivirine for HIV -1 Infection","inPlainEnglish":"Phase IV, multi-site, open-label, non-randomly assigned study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.","whoItsFor":["Ages 18 Years to any","Women only","At screening, age 18 years or older","Has a viable, intrauterine, singleton pregnancy with fetal ultrasound with an estimated gestational age (EGA) between 10 0/7 and 23 6/7 weeks (inclusive) at entry","At entry, intending to deliver at a study-associated medical facility and remain in the geographic area of the study for the duration of anticipated follow-up","Was diagnosed with HIV prior to the current pregnancy","Has a documented plasma HIV RNA result less than 50 copies/mL from a specimen collected within 28 days prior to entry","Received first dose of CAB LA + RPV LA prior to entry (before or after conception of the current pregnancy) and is expected to receive CAB LA + RPV LA on a Q4W schedule for the duration of study participation"],"whoShouldSkip":["History of treatment/virologic failure associated with documented or suspected viral resistance to CAB or RPV (including oral RPV)","Has any of the following during the current pregnancy: (1) Abnormal placentation, including placenta previa (complete) and placenta accreta/increta/percreta; (2) Cervical cerclage/cervical incompetence; (3) Abnormal fetal anatomy","Receipt of any prohibited medication within seven days prior to entry","Enrolled in another clinical trial of an investigational agent, device, or vaccine that may impact the PK of CAB or RPV","Receipt of an investigational agent or chemotherapy within 30 days prior to study entry"],"whatHappens":"If you join, the listed intervention(s) are Every 4-week long-acting injectable cabotegravir and rilpivirine, or Every 4-week long-acting injectable cabotegravir and rilpivirine. The registry lists allocation as randomized. Phase IV, multi-site, open-label, non-randomly assigned study of the pharmacokinetics (PK) of long-acting injectable cabotegravir and rilpivirine (CAB LA + RPV LA) during pregnancy and postpartum.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 40 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.536Z"},{"nctId":"NCT07639359","title":"Subanesthetic Ketamine Infusions for Depressive Symptoms in Intensive Care Unit Patients","officialTitle":"Ketamine In Depression - Intensive Care Unit Trial (KID-ICU): A Phase II Randomized, Double-Blind, Placebo-Controlled Multicenter Study of Ketamine Infusion for Depressive Symptoms in Intensive Care Unit Patients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hospital Italiano de Buenos Aires","sponsorClass":"OTHER","summary":"Depressive symptoms are common among patients admitted to the intensive care unit (ICU) and may adversely affect recovery, participation in care, treatment adherence, quality of life, and outcomes after critical illness. Conventional antidepressants have limited utility for rapidly treating depressive symptoms during an ICU admission because of their delayed onset of action and potential drug interactions in medically complex patients.\n\nKetamine is an N-methyl-D-aspartate receptor antagonist with rapid antidepressant effects when administered intravenously at subanesthetic doses. However, evidence regarding its efficacy and safety for depressive symptoms developing during critical illness remains limited.\n\nThe KID-ICU trial is a Phase II randomized, double-blind, placebo-controlled, multicenter trial evaluating subanesthetic intravenous ketamine for moderate-to-severe depressive symptoms in adult ICU patients. Eligible participants are adults who have been admitted to an ICU for 6 or more days and have a Patient Health Questionnaire-9 (PHQ-9) score of 10 or greater.\n\nParticipants will be randomized in a 1:1 ratio to receive either intravenous ketamine at 0.5 mg/kg, with a maximum dose of 60 mg per infusion, administered over 60 minutes once daily for 2 consecutive days, or normal saline placebo with an identical volume, appearance, and infusion duration.\n\nThe primary efficacy outcome is the change in PHQ-9 total score from baseline to Day 14 after the second scheduled infusion. Secondary outcomes include the longitudinal trajectory of PHQ-9 scores through Day 30, clinically meaningful PHQ-9 response at Day 14, anxiety and depressive symptoms assessed with the Hospital Anxiety and Depression Scale, Clinical Global Impression scores, prespecified safety events, time to ICU and hospital discharge alive, and 30-day all-cause mortality.\n\nA total of 50 participants will be enrolled across participating ICUs in Argentina. Psychiatric and clinical follow-up will be provided to all participants regardless of treatment assignment.","conditions":["Critical Illness","Depressive Symptoms"],"keywords":["ketamine","intensive care","Depressive Symptoms","Critical Illness","PHQ-9"],"interventions":[{"type":"DRUG","name":"Ketamine (0.5 mg/kg)"},{"type":"OTHER","name":"Normal Saline (0.9% NaCl)"}],"enrollment":50,"startDate":"2026-05-14","completionDate":"2028-05-01","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"\\*\\*Inclusion Criteria:\\*\\*\n\n* Age 18 to 99 years.\n* Male or female.\n* Admission to an intensive care unit for 6 or more days at the time of screening.\n* Moderate to severe depressive symptoms, defined as a Patient Health Questionnaire-9 score of 10 or greater at screening.\n* Ability to provide informed consent.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* History of psychosis or hallucinations, as assessed by review of the electronic medical record and patient interview during screening.\n* History of prolonged QT interval.\n* History of dementia.\n* History of major depressive disorder before the current intensive care unit admission.\n* History of psychiatric diagnosis, including dissociative disorder, primary psychotic disorder, mania with psychosis, pervasive developmental disorder, cognitive disorder, or anorexia nervosa.\n* Known allergy to ketamine or diphenhydramine.\n* History of increased intracranial pressure, hypertensive hydrocephalus, or increased intraocular pressure.\n* Hemodynamic instability at the time of screening, defined as peripheral oxygen saturation \\<95%, systolic blood pressure \\<90 mmHg or \\>180 mmHg, heart rate \\<50 or \\>120 beats/min, or respiratory rate \\<10 or \\>30 breaths/min.\n* Patient refusal to participate or to provide informed consent.\n* Pregnancy, postpartum period within 2 months, or breastfeeding.\n* Presence of intracranial mass or vascular lesion.\n* Altered mental status precluding informed consent.\n* Body weight \\>115 kg or \\<45 kg.\n* Active psychosis.\n* Current treatment with medications that may interfere with the N-methyl-D-aspartate receptor system, including lamotrigine, acamprosate, memantine, riluzole, or lithium.\n* Current treatment with aminophylline or theophylline.\n* Active substance withdrawal or use of hallucinogens, including cannabis, in the past month, as determined by clinical interview and urine drug screening.","locations":[{"facility":"Mayo Clinic","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Italiano de Buenos Aires - Sede Central","city":"Buenos Aires","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ivan A. Huespe, M.D., M.P.H.","phone":"+5493425382554","email":"ivan.huespe@hospitalitaliano.org.ar"}],"primaryOutcomes":["Change in PHQ-9 Score from Baseline to Day 14 Post-Last Infusion","Incidence of Safety Events During and After Ketamine Infusion"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["ketamine"],"locationSlugs":["jacksonville-florida","buenos-aires-argentina"],"enrichment":{"headline":"Phase 2: testing Ketamine (0.5 mg/kg) for Critical Illness","inPlainEnglish":"Depressive symptoms are common among patients admitted to the intensive care unit (ICU) and may adversely affect recovery, participation in care, treatment adherence, quality of life, and outcomes after critical illness. Conventional antidepressants have limited utility for rapidly treating depressive symptoms during an ICU admission because of their delayed onset of action and potential drug interactions in medically complex patients.","whoItsFor":["Ages 18 Years to 99 Years","Age 18 to 99 years","Admission to an intensive care unit for 6 or more days at the time of screening","Moderate to severe depressive symptoms, defined as a Patient Health Questionnaire-9 score of 10 or greater at screening"],"whoShouldSkip":["History of psychosis or hallucinations, as assessed by review of the electronic medical record and patient interview during screening","History of prolonged QT interval","History of dementia","History of major depressive disorder before the current intensive care unit admission","History of psychiatric diagnosis, including dissociative disorder, primary psychotic disorder, mania with psychosis, pervasive developmental disorder, cognitive disorder, or anorexia nervosa","Known allergy to ketamine or diphenhydramine","History of increased intracranial pressure, hypertensive hydrocephalus, or increased intraocular pressure"],"whatHappens":"If you join, the listed intervention(s) are Ketamine (0.5 mg/kg), or Normal Saline (0.9% NaCl). The registry lists allocation as randomized. Depressive symptoms are common among patients admitted to the intensive care unit (ICU) and may adversely affect recovery, participation in care, treatment adherence, quality of life, and outcomes after critical illness.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.791Z"},{"nctId":"NCT07640802","title":"Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy","officialTitle":"Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nIrritability is defined as proneness to anger that may impair a person's ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.\n\nObjective:\n\nTo test different types of therapy for children and teens with severe irritability.\n\nEligibility:\n\nPeople aged 8 to 16.5 years with severe irritability. Their parents are also needed.\n\nDesign:\n\nParticipants will have 28 study visits in 18 months.\n\nThey will have a baseline visit. They will answer questions about their mood, behavior, and daily life.\n\nAll parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.\n\nEach parent and child will have 1 of 3 therapy types:\n\nExposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.\n\nManagement therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.\n\nPsychoeducation/supportive psychotherapy (child and/or parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.\n\nSessions may be videotaped. Participants may opt out of being recorded.\n\nParticipants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.","conditions":["Irritability","Disruptive Mood Dysregulation Disorder","Oppositional Defiant Disorder","Attention Deficit Hyperactivity Disorder"],"keywords":["Irritability","Parent Management Training","Psychosocial Treatment","Exposure Therapy","Children","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy"],"interventions":[{"type":"BEHAVIORAL","name":"Psychotherapy"}],"enrollment":410,"startDate":"2026-11-15","completionDate":"2036-12-31","sex":"ALL","minAge":"8 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA FOR YOUTH:\n\n  1. Age 8-16.5 years\n  2. Caregiver and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property.\n\n  2a. Such events occur, on average, at least three times a week.\n\n  2b. This irritability is impairing in at least two of three domains (home, school, peers)\n\n  3\\. Patients must be fluent in English\n\n  3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are\n\ncurrently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance/support are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n\n4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n\n5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment.\n\nINCLUSION CRITERIA FOR PARENT:\n\n1. Parent of a child eligible for this protocol that can attend 12 parent sessions\n2. Fluent in English\n\nEXCLUSION CRITERIA FOR YOUTH:\n\nParticipants will be screened to exclude participants who would not be able to engage in psychotherapy.\n\n1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.\n2. IQ \\< 70 as assessed by a WASI or assessment by trained clinical staff\n3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nEXCLUSION CRITERIA FOR PARENTS:\n\n1. IQ \\< 70\n2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melissa A Brotman, Ph.D.","phone":"(301) 435-6645","email":"irritablekids@mail.nih.gov"}],"primaryOutcomes":["Clinician Affective Reactivity Index (CL-ARI)","Clinical Global Impressions Improvement (CGI-I)","CBT for Irritability-Adherence Scale","Working Alliance Inventory (WAI)","Therapeutic Alliance Scale for Children-revised (TASC-r)"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Psychotherapy for Irritability","inPlainEnglish":"Background: Irritability is defined as proneness to anger that may impair a person's ability to function. It is a common reason for why some children need mental health care.","whoItsFor":["Ages 8 Years to 17 Years","2a. Such events occur, on average, at least three times a week","2b. This irritability is impairing in at least two of three domains (home, school, peers)","3\\. Patients must be fluent in English","3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are","4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more)","5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment","who can join FOR PARENT:"],"whoShouldSkip":["you would be screened to exclude participants who would not be able to engage in psychotherapy","Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments","IQ \\< 70 as assessed by a WASI or assessment by trained clinical staff"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 410 people at Bethesda. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.640Z"},{"nctId":"NCT07641517","title":"A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain","officialTitle":"Randomized, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate LY4065967 for the Treatment of Osteoarthritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.","conditions":["Osteoarthritis, Knee","Chronic Pain"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4065967"},{"type":"DRUG","name":"Placebo"}],"enrollment":150,"startDate":"2026-06-25","completionDate":"2027-04","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have presence of index knee pain for more than 12 weeks at screening\n* Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee\n* Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)\n* Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening\n\nExclusion Criteria:\n\n* Are pregnant or breastfeeding\n* Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening\n* Have presence of surgical hardware or other foreign body in the index knee\n* Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.\n* Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening\n* Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (\\>140 mm Hg) and diastolic BP\\>90 mm Hg) at screening\n* Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator","locations":[{"facility":"Central Research Associates","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synexus Clinical Research US, Inc.","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arizona Research Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Desert Oasis Healthcare Medical Group","city":"Palm Springs","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CMR of Greater New Haven","city":"Hamden","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradenton Research Center, Inc.","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - DeLand Clinical Research Unit","city":"DeLand","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 MEDICAL Research THE VILLAGES","city":"Lady Lake","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research ORLANDO","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Merritt Island Medical Research, LLC","city":"Merritt Island","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Research Group","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New Horizon Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc.","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precision Clinical Research","city":"Sunrise","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Lady Lake","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucida Clinical Trials","city":"New Bedford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedVadis Research Corporation","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Research Group, Inc.","city":"Bay City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinvest Research LLC","city":"Springfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research, LLC","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lillestol Research","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"META Medical Research Institute","city":"Dayton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altoona Center For Clinical Research","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northwest Clinical Research Center","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rainier Clinical Research Center","city":"Renton","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ponce Medical School Foundation Inc.","city":"Ponce","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","phoenix-arizona","palm-springs-california","riverside-california","san-diego-california","hamden-connecticut","bradenton-florida","deland-florida","lady-lake-florida","maitland-florida","merritt-island-florida","miami-florida","new-port-richey-florida","ocala-florida","sunrise-florida","the-villages-florida","winter-park-florida","woodstock-georgia","chicago-illinois","new-orleans-louisiana","new-bedford-massachusetts","waltham-massachusetts","bay-city-michigan","city-of-saint-peters-missouri","springfield-missouri","rochester-new-york","fargo-north-dakota","dayton-ohio","tulsa-oklahoma","duncansville-pennsylvania","austin-texas","bellevue-washington","renton-washington","ponce-puerto-rico"],"enrichment":{"headline":"Phase 2: testing LY4065967 for Osteoarthritis, Knee","inPlainEnglish":"The main purpose of this study is to test the safety and how well it works of study drug for the treatment of knee pain due to osteoarthritis (OA). This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292), which is a protocol to accelerate the development of new treatments for chronic pain.","whoItsFor":["Ages 40 Years to any","Have presence of index knee pain for more than 12 weeks at screening","Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee","Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)","Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening"],"whoShouldSkip":["Are pregnant or breastfeeding","Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening","Have presence of surgical hardware or other foreign body in the index knee","Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee","Have had any joint replacement of the lower extremity, such as hip, knee or ankle, in the 6 months prior to screening","Have an abnormal blood pressure (BP) (systolic BP greater than 140 millimeters mercury (\\>140 mm Hg) and diastolic BP\\>90 mm Hg) at screening","Have history or current clinically significant cardiac disease, including arrhythmia, aortic aneurysm, heart failure, current electrolyte abnormalities, or any other conditions that could predispose to arrhythmia in the judgement of the investigator"],"whatHappens":"If you join, the listed intervention(s) are LY4065967, or Placebo. The registry lists allocation as randomized. The main purpose of this study is to test the safety and how well it works of study drug for the treatment of knee pain due to osteoarthritis (OA).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at 36 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.517Z"},{"nctId":"NCT07642908","title":"Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation","officialTitle":"Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"This study explores how a specific genetic mutation of leucine-rich repeat kinase 2 (LRRK2) affects individuals with Parkinson's disease (PD), comparing those with the mutation to others with Parkinson's disease and without the mutation (iPD). Participants will complete positron emission tomography (PET) and magnetic resonance imaging (MRI) brain imaging, cognitive tests, motor tests, sensory tests, and questionnaires. The aims of this study are to compare brain chemicals in LRRK2 PD patients with iPD patients and to correlate brain chemicals with motor and cognitive tests in LRRK2 PD and iPD patients.","conditions":["Parkinson Disease"],"keywords":["Parkinson's Disease","LRRK","LRRK2","functional neuroimaging"],"interventions":[],"enrollment":15,"startDate":"2025-09-18","completionDate":"2027-04-01","sex":"ALL","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or Female, age 45 years and over.\n2. Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992).\n3. Presence of LRRK2 mutation as confirmed by referral from UM Movement Disorders clinic, medical record review, or participation in the PDGENEration study.\n\nExclusion Criteria:\n\n1. Evidence of atypical parkinsonism.\n2. Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia.\n3. Evidence of large vessel stroke or mass lesion on MRI.\n4. Regular use of typical anti-cholinergic drugs or cholinesterase inhibitors.\n5. History of deep brain stimulation surgery.\n6. Pregnant or nursing.\n7. Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.\n8. Cognitive impairment that results in the inability to give consent, as demonstrated by the Decision Making Capacity Tool.\n9. Any other condition or criterion that would preclude safe and meaningful participation in the study.","locations":[{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nathan Alexander, BSc","phone":"734-998-6894","email":"natealex@med.umich.edu"}],"primaryOutcomes":["Cholinergic Differences Between leucine-rich repeat kinase 2 (LRRK2) Parkinson's disease (PD) and Idiopathic/non-LRRK2 PD (iPD)","Dopaminergic Differences Between LRRK2-PD and iPD","Association of Cholinergic Data With Cognition in LRRK2-PD","Association of Cholinergic Data With Postural Instability and Gait Difficulties (PIGD) in LRRK2-PD","Association of Dopaminergic Data With Cognition in LRRK2-PD","Association of Dopaminergic Data With PIGD in LRRK2-PD"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Striatal and Extra-Striatal Cholinergic Terminal Density in LRRK2-PD Mutation","inPlainEnglish":"This study explores how a specific genetic mutation of leucine-rich repeat kinase 2 (LRRK2) affects individuals with Parkinson's disease (PD), comparing those with the mutation to others with Parkinson's disease and without the mutation (iPD). Participants will complete positron emission tomography (PET) and magnetic resonance imaging (MRI) brain imaging, cognitive tests, motor tests, sensory tests, and questionnaires.","whoItsFor":["Ages 45 Years to any","Male or Female, age 45 years and over","Diagnosis of PD based on the United Kingdom Parkinson's Disease Society Brain Bank Diagnostic Research Criteria (Hughes et al., 1992)","Presence of LRRK2 mutation as confirmed by referral from UM Movement Disorders clinic, medical record review, or participation in the PDGENEration study"],"whoShouldSkip":["Evidence of atypical parkinsonism","Contra-indications to MR imaging including but not limited to pacemakers, aneurysm clips, intraocular metal, cochlear implant, or severe claustrophobia","Evidence of large vessel stroke or mass lesion on MRI","Regular use of typical anti-cholinergic drugs or cholinesterase inhibitors","History of deep brain stimulation surgery","Pregnant or nursing","Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 15 people at Ann Arbor. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.667Z"},{"nctId":"NCT07644117","title":"Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease","officialTitle":"Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Shmuel Kivity, MD","sponsorClass":"OTHER_GOV","summary":"This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.\n\nParticipants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.","conditions":["IBD (Inflammatory Bowel Disease)","Crohn Disease (CD)","Ulcerative Colitis (UC)"],"keywords":["IBD","Anti-TNF","Response to treatment"],"interventions":[{"type":"OTHER","name":"This is an observational study with no intervention. Patients will receive anti- TNF therapy as part of their standard care"}],"enrollment":40,"startDate":"2025-01-04","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)\n* Anti-TNF naïve\n* Clinically active disease (HBI\\>5 for CD, p-MS≥ 3 for UC)\n* Elevated inflammatory indices CRP\\>10 or fecal calprotectin\\>250\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Anti-TNF experienced\n* Unable to complete the study protocol","locations":[{"facility":"Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rony Izhar, PhD","phone":"+97237772613","email":"ronyi@tlvmc.gov.il"},{"name":"Ayal Hirsch, MD","phone":"+972535289492","email":"ayalh@tlvmc.gov.il"}],"primaryOutcomes":["Rates of clinical response in UC patients","Rates of clinical response in UC patients","Rates of clinical response in UC patients","Rates of clinical response in CD patients","Rates of clinical response in CD patients","Rates of clinical response in CD patients","Rates of clinical remission for UC","Rates of clinical remission for UC","Rates of clinical remission for UC","Rates of clinical remission for CD","Rates of clinical remission for CD","Rates of clinical remission for CD"],"hasResults":false,"conditionSlugs":["als","crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["tel-aviv-israel"],"enrichment":{"headline":"Not a traditional drug phase: This is an observational study with no intervention. Patients will receive anti- TNF therapy as part of their standard care for IBD (Inflammatory Bowel Disease)","inPlainEnglish":"This watch-and-measure (no experimental treatment required) study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.","whoItsFor":["Ages 18 Years to any","Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)","Clinically active disease (HBI\\>5 for CD, p-MS≥ 3 for UC)","Elevated inflammatory indices a blood inflammation marker (CRP)\\>10 or fecal calprotectin\\>250"],"whoShouldSkip":["Anti-TNF experienced","Unable to complete the study protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Tel Aviv. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.270Z"},{"nctId":"NCT07644403","title":"Phase I/IIa Clinical Trial of IMC001 in Patients With Advanced Epithelial Solid Tumors.","officialTitle":"Phase I/IIa Clinical Trial Evaluating the Safety and Efficacy of IMC001 in Patients With Advanced Epithelial Solid Tumors.","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Suzhou Immunofoco Biotechnology Co., Ltd","sponsorClass":"INDUSTRY","summary":"This is an open -label phase I /IIa study designed to evaluate the safety and efficacy of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate efficacy .In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to evaluate the safety and tolerability of autologous IMC001 treatment . In the expansion phase, at least two dose groups will be selected , each recruiting 5-10 subjects. Combined with the subjects from the escalation phase, each dose group will be expanded to approximately 10 subjects to determine the recommended RP2D dose for progression to Phase IIa . DLT ( digestive tract aging) assessment will be performed on subjects in each cohort within 28 days of IMC001 infusion . the RP2D is determined , approximately 6-20 subjects will be initially enrolled at this dose for each selected tumor type to further explore the efficacy and safety of autologous IMC001 for this indication. Subsequently, the protocol may be revised based on statistical hypotheses and regulatory requirements to continue enrolling subjects in the selected tumor types to further validate the efficacy and safety in specific tumor types.the date on which the last participant completes a two-year follow-up visit, is lost to follow up, withdraws informed consent, or dies (whichever occurs first) . It is important to note that for long-term follow-up programs such as ADA, RCL, and VIS (up to 15 years), which require protocol-based follow-up, these follow-ups will be conducted continuously according to protocol and regulatory requirements. However, the actual study participation time for each participant will vary depending on screening requirements, response to treatment, long-term follow-up arrangements, and survival status .","conditions":["Epithelial Cancer Patients"],"keywords":[],"interventions":[{"type":"DRUG","name":"Autologous CAR-T cell injection targeting EpCAM"}],"enrollment":30,"startDate":"2026-03-05","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. to provide a signed and dated informed consent form before conducting any research-related procedures , and willing and able to comply with all research procedures.\n2. Applicants must be 18 years of age or older and 75 years of age or younger; both male and female applicants are welcome .\n3. Subjects with histologically or cytologically confirmed locally advanced/metastatic epithelial solid tumors , including but not limited to subjects with advanced gastric cancer/gastroesophageal junction adenocarcinoma, triple-negative breast cancer, biliary tract tumors, ovarian cancer, colorectal cancer, pancreatic cancer, gastrointestinal and pancreatic neuroendocrine tumors, etc.\n4. Disease progression or intolerance to standard systemic therapy , including:\n\n   * Gastric cancer and gastroesophageal junction adenocarcinoma that have failed or are intolerant of at least two lines of standard systemic therapy. If first-line three-drug combination therapy has failed or is intolerant, enrollment may be made after thorough investigator evaluation.\n   * Triple-negative breast cancer: Subjects with unresectable locally advanced or metastatic triple-negative breast cancer who have failed at least two lines of standard systemic therapy. All subjects must have previously received taxane therapy, regardless of the stage of disease at the time of treatment.\n   * Other subjects with epithelial solid tumors who have failed or are intolerant of standard treatment.\n5. Tumor tissue samples (primary or metastatic, archived or newly collected) from the expected subjects, tested by the central laboratory, are EpCAM histologically positive (defined as tumor cell positivity ≥10% and staining intensity ≥1+).\n6. The expected survival period of the subjects is ≥12 weeks .\n7. According to RECIST 1.1 criteria, there should be at least one stably measurable target lesion (where the largest lesion should be ≤4). In the 3×10⁵ CAR -T cells/kg dose group, subjects with evaluable lesions (unmeasurable lesions) can be admitted.\n8. ECOG performance status score 0-1 .\n9. The subject has adequate organ and bone marrow function. Laboratory screening must meet the following criteria: all laboratory test results should be within the stable ranges outlined below, and there should be no ongoing supportive treatment. If any laboratory test result is abnormal according to the following criteria, a repeat test may be performed within one week. If the test results still do not meet the following criteria, the subject's screening has failed.\n\n   1. Blood tests \\[No intensive blood transfusions (≥2 times within 1 week), platelet transfusions, or cell growth factor injections (excluding recombinant erythropoietin)) within 7 days prior to the test\\]: Neutrophil count (ANC) ≥1.5×10⁹ / L; Platelet count (PLT) ≥100 × 10⁹ / L; Hemoglobin content (Hb) ≥9.0g / dL; Lymphocyte count ( ALC ) ≥0.5× 10⁹ /L ;\n   2. Liver function: alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, serum total bilirubin (TB) ≤ 2 × ULN; for subjects with liver metastases, AST and ALT \\< 5 × ULN ;\n   3. Kidney function: Serum creatinine ≤1.5×ULN; if serum creatinine \\>1.5×ULN, creatinine clearance rate \\>50mL/min is required (according to the Cockcroft-Gault formula); qualitative urine protein ≤1+; if qualitative urine protein ≥2+, a 24-hour urine protein quantification test is required (if the 24-hour urine protein quantification test is \\<1g, it is acceptable).\n   4. Amylase and lipase ≤1.5×ULN; alkaline phosphatase (ALP) ≤2.5×ULN, and for subjects with bone metastases, ALP \\<5×ULN ;\n   5. Coagulation function: Activated partial thromboplastin time ≤ 1.5 ULN, prothrombin time ≤ 1.5 × ULN ;\n10. All toxicities resulting from prior antitumor therapy were reduced to grade 0-1 (according to NCI CTCAE version 5.0) or to a level acceptable to the inclusion criteria. Other toxicities, such as alopecia and vitiligo, which the investigators deemed not to pose a safety risk to the subjects, were excluded .\n\nReproductive status: Female subjects of reproductive age or male subjects whose sexual partners are women of reproductive age, who are willing to use medically approved and highly effective contraceptive methods, such as intrauterine devices or condoms, from the time they sign the informed consent form until 12 months after cell infusion (women of reproductive age include premenopausal women and women within 24 months after menopause) .\n\nExclusion Criteria:\n\n1. Pregnant and breastfeeding women .\n2. Positive for human immunodeficiency virus (HIV) antibodies; hepatitis B virus infection ( if the subject is positive for hepatitis B surface antigen, regardless of whether the core antibody is negative or positive, they can also be enrolled if the viral DNA load is negative, and prophylactic antiviral treatment should be considered ); acute or chronic active hepatitis C (positive for HCV antibodies); positive for syphilis antibodies; Epstein-Barr virus (EBV) infection ( positive for IgM or known EBV infection ); cytomegalovirus (CMV) infection (positive for IgM); positive for human T-lymphotropic virus (HTLV). The results of the above pathogen tests are subject to the results of the central laboratory .\n3. Severe infections that are in an active phase or poorly controlled clinically .\n4. The patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment .\n5. Extensive or diffuse lung metastases , extensive or diffuse liver metastases , extensive or diffuse bone metastases .\n6. Subjects with intestinal obstruction or obstructive jaundice who are deemed unsuitable for participation in this trial by the researchers .\n7. Blood oxygen saturation ≤95% without oxygen supplementation .\n8. Patients with other serious lung diseases that may limit their participation in this study, such as pulmonary embolism, chronic obstructive pulmonary disease, symptomatic or poorly controlled interstitial lung disease, or clinically significant abnormalities in pulmonary function tests .\n9. Subjects with a known history or current hepatic encephalopathy requiring treatment; subjects with a current or history of central nervous system disorders, such as seizures, cerebral ischemia/hemorrhagic disease, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system .\n10. Central nervous system metastasis or meningeal metastasis .\n11. Currently, patients have unstable heart disease requiring treatment or heart disease that cannot be controlled by treatment, or hypertension that is poorly controlled according to investigators (defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure \\>100 mmHg after standard antihypertensive drug treatment); or diabetes that is poorly controlled despite standard treatment (fasting blood glucose ≥10.2 mmol/L) .\n12. If any of the following cardiac clinical symptoms or conditions exist within 6 months prior to cell infusion:\n\n    1. Left ventricular ejection fraction (LVEF) \\< 50%;\n    2. History of myocardial infarction within the past year; or unstable angina; or percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG); or use of a pacemaker;\n    3. Resting electrocardiogram examination: QTc F \\> 450ms (male) or QTc F \\> 470ms (female);\n    4. An electrocardiogram at rest reveals clinically significant abnormalities (such as abnormalities in heart rate, conduction, or morphological characteristics) or complete left bundle branch block or third-degree atrioventricular block or a PR interval \\>250 ms.\n13. Evidence of a significant coagulation disorder or other obvious risk of bleeding, including:\n\n    1. Abnormal coagulation function that is clinically significant;\n    2. History of intracranial hemorrhage or spinal cord hemorrhage;\n    3. Patients with tumor lesions invading major blood vessels and posing a significant risk of bleeding;\n    4. Subjects who currently have unstable or active ulcers or active gastrointestinal bleeding;\n    5. An embolic event occurred within 6 months prior to cell reinfusion;\n    6. Within one month prior to cell reinfusion, there has been clinically significant hemoptysis or obvious bleeding from tumor lesions;\n    7. Had a major trauma or major surgery within one month prior to enrollment;\n    8. The presence of any bleeding disorder, such as hemophilia, von Willebrand disease, etc.;\n    9. The patient has received anticoagulation therapy (excluding low molecular weight heparin) for therapeutic purposes within 2 weeks prior to cell reinfusion.\n    10. Subjects are receiving routine anticoagulation therapy (such as warfarin or heparin). Subjects require long-term antiplatelet therapy (aspirin \\>300 mg/day; clopidogrel \\>75 mg/day); dipyridamole, ticlopidine, or cilostazol, etc.\n14. The patient has received systemic steroids equivalent to \\>15 mg/day of prednisone for more than 3 days within 2 weeks prior to apheresis, excluding inhaled steroids .\n15. Subjects requiring systemic therapy with corticosteroids or other immunosuppressive drugs during treatment. Subjects with any active autoimmune disease, or a history of autoimmune disease with anticipated relapse (including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, and asthma requiring medical intervention with bronchodilators). Exceptions include: type 1 diabetes; skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis); alopecia; hypothyroidism requiring only hormone replacement therapy; asthma that was completely remitted in childhood and requires no intervention in adulthood; or other conditions not expected to relapse in the absence of external triggers .\n16. Subjects with a prior or concurrent history of other malignant tumors, except in the following circumstances:\n\n    1. Basal cell or squamous cell carcinoma that has undergone adequate treatment (sufficient wound healing is required before enrollment in the study).\n    2. Cervical cancer or breast cancer in situ, cured and with no signs of recurrence for at least 3 years prior to the study;\n    3. The primary malignant tumor has been completely removed and has been in complete remission for ≥5 years ; d ) The concurrent malignant tumor was an epithelial tumor that expressed EpCAM .\n17. Subjects who have previously received other gene therapies, including but not limited to CAR-T therapy and TCR-T therapy .\n18. The following treatments or medications were received before cell reinfusion: chemotherapy, targeted therapy, biotherapy, endocrine therapy, immunotherapy, or other anti-tumor treatments (excluding treatments that meet the protocol requirements before reinfusion, such as lymph node pretreatment and bridging therapy); less than 28 days or less than 5 half-lives since the first infusion treatment in this study (whichever is shorter); or traditional Chinese medicine treatment with anti-tumor indications received within 2 weeks before cell reinfusion .\n19. of severe allergies, such as anaphylactic shock .\n20. Subjects with severe mental disorders .\n21. Subjects who develop new cardiac arrhythmias, including but not limited to arrhythmias that cannot be controlled by medication; hypotension requiring vasopressors; or bacterial, fungal, or viral infections requiring intravenous antibiotics. Subjects receiving antibiotics to prevent infection may continue to participate in the trial at the investigator's discretion .\n22. The patient had participated in other interventional clinical studies and used investigational drugs within one month prior to the planned infusion of IMC001 .\n23. Subjects who received a live attenuated vaccine within 4 weeks prior to the planned single-donor administration or who are scheduled to receive a live attenuated vaccine during the study.\n24. Subjects with any other concurrent serious and /or uncontrolled medical conditions that the investigators deem unsuitable for participation in this trial.\n\nResearchers assessed that participants were unable or unwilling to comply with the requirements of the research protocol .","locations":[{"facility":"Beijing Cancer Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lin Shen, PhD","phone":"+86-010-88196561","email":"doctorshenlin@sina.cn"}],"primaryOutcomes":["Observe dose limiting toxicity (DLTs) of IMC001 within 28 days after administration according to the DLT definition in the protocol","After treatment with IMC001, the recommended Phase II dose (RP2D) is determined based on dose limiting toxicity (DLT) and clinical response, including potential side effects","Evaluate the objective response rate (ORR) of tumors based on RECIST 1.1"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["car-t"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Autologous CAR-T cell injection targeting EpCAM for Epithelial Cancer Patients","inPlainEnglish":"This is an open -label phase I /IIa study designed to measure the safety and how well it works of IMC001 in patients with advanced epithelial solid tumors. The study comprises two parts: a phase I dose-escalation phase and a phase IIa phase to further explore and validate how well it works .In the Phase I dose-escalation phase of this study, approximately 7-15 subjects with advanced epithelial solid tumors will be recruited to measure the whether it is safe and how hard side effects are to live with of autologous IMC001 treatment .","whoItsFor":["Ages 18 Years to 75 Years","Applicants must be 18 years of age or older and 75 years of age or younger; both male and female applicants are welcome","Disease progression or intolerance to standard systemic therapy , including:","Other subjects with epithelial solid tumors who have failed or are intolerant of standard treatment","Tumor tissue samples (primary or metastatic, archived or newly collected) from the expected subjects, tested by the central laboratory, are EpCAM histologically positive (defined as tumor cell positivity ≥10% and staining intensity ≥1+)","The expected survival period of the subjects is ≥12 weeks","According to RECIST 1.1 criteria, there should be at least one stably measurable target lesion (where the largest lesion should be ≤4). In the 3×10⁵ CAR -T cells/kg dose group, subjects with evaluable lesions (unmeasurable lesions) can be admitted","how well you can do daily activities (ECOG score) score 0-1"],"whoShouldSkip":["Pregnant and breastfeeding women","Severe infections that are in an active phase or poorly controlled clinically","The patients had uncontrollable pleural effusion, pericardial effusion, and ascites before enrollment","Extensive or diffuse lung metastases , extensive or diffuse liver metastases , extensive or diffuse bone metastases","Subjects with intestinal obstruction or obstructive jaundice who are deemed unsuitable for participation in this trial by the researchers","Blood oxygen saturation ≤95% without oxygen supplementation","Central nervous system metastasis or meningeal metastasis"],"whatHappens":"If you join, the listed intervention(s) are Autologous CAR-T cell injection targeting EpCAM. The registry lists allocation as na. This is an open -label phase I /IIa study designed to measure the safety and how well it works of IMC001 in patients with advanced epithelial solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.400Z"},{"nctId":"NCT07644559","title":"A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer","officialTitle":"A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, as Monotherapy and With Cetuximab, in Patients With Metastatic KRAS G12D-Mutated Pancreatic Cancer (TARGET-D 201)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Verastem, Inc.","sponsorClass":"INDUSTRY","summary":"This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer","conditions":["Pancreatic Ductal Adenocarcinoma (PDAC)","G12D Mutated KRAS"],"keywords":["KRAS G12D mutation","KRAS","PDAC","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer","Pancreatic Neoplasms","RAS"],"interventions":[{"type":"DRUG","name":"VS-7375"},{"type":"DRUG","name":"cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction)"}],"enrollment":185,"startDate":"2026-06-16","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologic or cytologic confirmed PDAC\n* Measurable disease per RECIST 1.1\n* Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)\n* ECOG PS=0 or 1\n\nAdequate organ function\n\nVS-7375 + cetuximab (2L PDAC) :\n\n-Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months\n\nVS-7375 + cetuximab (1L PDAC) :\n\n-Treatment-naïve or received ≤ 1 cycle of SoC for metastatic disease\n\nExclusion criteria:\n\n* Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS\n* Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter\n* Major surgery within 4 weeks of first treatment dose\n* Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose\n* History of drug-induced Interstitial Lung Disease\n* Receipt of prior direct RAS inhibitor\n* Untreated or symptomatic CNS metastasis\n* Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter\n* Receipt of PPI, P-CABs, or H2 blocker within 5 days\n* Inability to swallow oral medication\n* Other protocol-defined inclusion/exclusion criteria may apply","locations":[{"facility":"START- Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars-Sinai Medical Center","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Valkyrie Clinical Trials","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global- Coral Springs","city":"Coral Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinical Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global- Tamarac","city":"Tamarac","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinical Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START New Jersey","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU-Manhattan","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Dallas","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START- San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START- Mountain Region","city":"West Valley City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UVA Health","city":"Charlottesville","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Cancer Specialists","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Mason","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UW Health","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Macquarie University Hospital","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Calvary Mater Newcastle","city":"Waratah","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre Townsville","city":"Hyde Park","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Kurralta Park","city":"Kurralta Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre- Hobart","city":"Hobart","state":"Tasmania","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alfred Hospital","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICON Cancer Centre","city":"South Brisbane","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Health Sciences Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Center","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global- San Juan","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR- Yauco","city":"Yauco","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Verastem Call Center","phone":"7812924204","email":"VS-7375-201TrialSupport@verastem.com"},{"name":"Luke Chung, MD","phone":"","email":"VS-7375-201Medical@verastem.com"}],"primaryOutcomes":["Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1","To characterize the safety and tolerability of VS-7375 monotherapy or in combination with cetuximab, administered on a daily oral schedule in participants with KRAS G12D-mutated PDAC."],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["los-angeles-california","coral-springs-florida","jacksonville-florida","tamarac-florida","tampa-florida","chicago-illinois","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","grand-rapids-michigan","rochester-minnesota","st-louis-missouri","east-brunswick-new-jersey","new-york-new-york","chapel-hill-north-carolina","nashville-tennessee","fort-worth-texas","houston-texas","san-antonio-texas","west-valley-city-utah","charlottesville-virginia","fairfax-virginia","seattle-washington","madison-wisconsin","sydney-australia","waratah-australia","hyde-park-australia","kurralta-park-australia","hobart-australia","melbourne-australia","south-brisbane-australia","toronto-canada","san-juan-puerto-rico","yauco-puerto-rico"],"enrichment":{"headline":"Phase 2: testing VS-7375 for Pancreatic Ductal Adenocarcinoma (PDAC)","inPlainEnglish":"This study will assess the safety and how well it works of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer","whoItsFor":["Ages 18 Years to any","Histologic or cytologic confirmed PDAC","Measurable disease per RECIST 1.1","Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)","Adequate organ function","VS-7375 + cetuximab (2L PDAC) :","Received only 1 prior Tx in the metastatic setting; prior adjuvant counts as a line if progressed within 6 months","VS-7375 + cetuximab (1L PDAC) :"],"whoShouldSkip":["Have any documented co-existing pathogenic or likely pathogenic RAS mutation(s) in KRAS","Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter","Major surgery within 4 weeks of first treatment dose","Radiation therapy (RT) within 1 week of first treatment dose; RT to brain or lung within 2 weeks of first treatment dose","History of drug-induced Interstitial Lung Disease","Receipt of prior direct RAS inhibitor","Untreated or symptomatic CNS metastasis"],"whatHappens":"If you join, the listed intervention(s) are VS-7375, or cetuximab (or panitumumab if α-gal IgE+ or cetuximab reaction). The registry lists allocation as randomized. This study will assess the safety and how well it works of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 185 people at 38 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.448Z"},{"nctId":"NCT07645014","title":"Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Polycystic Ovarian Syndrome.","officialTitle":"Comparative Effects of Neurodynamic Stretch and Myofascial Pain Release in Dysmenorrhea, Quality Of Sleep And Stress In Polycystic Ovarian Syndrome.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Riphah International University","sponsorClass":"OTHER","summary":"The study will be a non-blinded randomized controlled trial, consisting of two groups. Non-probability Convenience sampling will be used to recruit participants who will meet the inclusion criteria. Group allocation will be performed using the sealed envelope method to ensure randomization of participants into experimental and control groups. The sample size will be 38 (19 in each group). Group A will receive neurodynamic stretches while Group B will receive myofascial pain release technique.","conditions":["Polycystic Ovarian Syndrome"],"keywords":["Dysmenorrhea","Myofascial pain release Neurodynamic stretch","Polycystic ovarian syndrome","Quality of sleep","Stress"],"interventions":[{"type":"OTHER","name":"Neurodynamic stretches"},{"type":"OTHER","name":"myofascial pain release technique Interventions:"}],"enrollment":38,"startDate":"2025-10-01","completionDate":"2026-07-01","sex":"FEMALE","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* • Age 18-35 years\n\n  * Diagnosed cases of PCOS\n  * Irregular periods until 3 months.\n  * Presence of dysmenorrhea (Check WaLIDD Questionnaire)\n  * BMI\n  * Age of Menarche (13 years)\n\nExclusion Criteria:\n\n* • History of endocrine disorders\n\n  * Endometriosis\n  * Tumour\n  * Any major surgeries\n  * Marital Status (un married)","locations":[{"facility":"Shaikh Zayed Hospital","city":"Lahore","state":"Punjab Province","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Imran Amjad, PhD","phone":"03324390125","email":"imran.amjad@riphah.edu.pk"}],"primaryOutcomes":["Mc Gill Questionnaire","WaLIDD Score","PSQI Scale"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["lahore-pakistan"],"enrichment":{"headline":"Not a traditional drug phase: Neurodynamic stretches for Polycystic Ovarian Syndrome","inPlainEnglish":"The study will be a non-blinded randomly assigned controlled trial, consisting of two groups. Non-probability Convenience sampling will be used to recruit participants who will meet the who can join.","whoItsFor":["Ages 18 Years to 35 Years","Women only","Diagnosed cases of PCOS","Irregular periods until 3 months","Presence of dysmenorrhea (Check WaLIDD Questionnaire)","Age of Menarche (13 years)"],"whoShouldSkip":["History of endocrine disorders","Any major surgeries","Marital Status (un married)"],"whatHappens":"If you join, the listed intervention(s) are Neurodynamic stretches, or myofascial pain release technique Interventions:. The registry lists allocation as randomized. The study will be a non-blinded randomly assigned controlled trial, consisting of two groups.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 38 people at Lahore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.796Z"},{"nctId":"NCT07645248","title":"A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)","officialTitle":"A Randomized, Double-blind, 2-way Crossover, Multicenter Study to Evaluate the Safety of Test Propellant HFA-152a and Reference Propellant HFA-134a When Administered Via Metered Dose Inhalers","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).","conditions":["Asthma"],"keywords":["Asthma","Bronchospasm","Hydrofluoroalkane","Metered dose inhaler","Propellant"],"interventions":[{"type":"DRUG","name":"HFA-152a"},{"type":"DRUG","name":"HFA-134a"}],"enrollment":110,"startDate":"2026-09-01","completionDate":"2026-12-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must be aged greater than equal to (\\>=)18 years at the time of signing the informed consent.\n* Participants with asthma for \\>= 6 months, defined as:\n\n  * Documented history of asthma, as defined by Global Initiative for Asthma (GINA)\n* Receiving one of following asthma treatments for at least 12 weeks prior to the screening visit and which is anticipated to remain stable for the duration of the study:\n* Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only\n* Inhaled corticosteroid (ICS)/SABA prn only\n* SABA prn plus ICS prn\n* SABA prn plus ICS maintenance\n* ICS/SABA prn plus ICS maintenance\n* SABA prn plus ICS/ Long-acting beta agonist (LABA) maintenance\n* ICS/SABA prn plus ICS/LABA maintenance\n* SABA prn plus ICS/ Long-acting muscarinic antagonist (LAMA)/LABA maintenance (open or closed triple therapy)\n* ICS/Formoterol combination therapy as reliever therapy\n* ICS/Formoterol combination therapy as maintenance therapy plus ICS/Formoterol combination as reliever therapy.\n* Leukotriene receptor antagonist (LTRA) as add-on any of the above is permitted\n* Xanthines as add-on to any of the above permitted\n* Biological therapies indicated for the treatment of asthma as add-on to any of the above are permitted (for example, but not limited to, mepolizumab, dupilumab, tezepelumab).\n* Participants with severity of disease:\n* Baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) \\>=50 percent (%) of predicted at screening.\n* Asthma Control Status\n* Asthma Control Questionnaire (ACQ)-6 score less than (\\<) 1.5 at screening (and randomization).\n* Asthma that has remained stable with no severe exacerbations within the last 3 months.\n* Participants who are current non-smokers, who have not used any inhaled tobacco or vaping products within 12 months of the start of the study, and with a total pack year history of less than equal to (\\<=)10 pack. The use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.\n* Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee.\n* Male and female participants are eligible.\n\nA female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:\n\n* Is a Participant of nonchildbearing potential (PONCBP) or\n* Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of \\<1%, 30 days prior to and during the study intervention period and for at least 24 hours after the last dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention in each Treatment Period.\n\n  * Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF).\n\nExclusion Criteria:\n\n* Participants with a history of life-threatening asthma.\n* Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than asthma.\n* Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening.\n* Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring \\>=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening.\n* Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results.\n* Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis).\n* Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines.\n* Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.).\n* Participants with exposure to more than four new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.\n* Participants with a known or suspected history of alcohol or drug abuse.\n* Any planned or anticipated changes in asthma medications during the study period.\n* Any planned environmental changes (e.g. employment changes, travel) which, in the Investigator's opinion, could lead to e.g. increased allergen exposure.\n* 12-Lead ECG abnormality: Significant abnormality in the 12-lead ECG performed at screening.\n* Alanine transaminase (ALT) \\>2 times Upper limit of normal (ULN).\n* Total bilirubin \\>1.5 times ULN; For participants with Gilbert's syndrome can be included with total bilirubin \\>1.5 times ULN if direct bilirubin is \\<=1.5 times ULN.\n* Participants with Cirrhosis or current unstable liver or biliary disease.\n* Participants with QTc \\>480 milliseconds (msec).","locations":[{"facility":"GSK Investigational Site","city":"Aventura","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Owensboro","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Columbia","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Henderson","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Medford","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Spartanburg","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Cypress","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Ciudad Autonoma de Buenos Aire","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Lujan de Cuyo","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Ajax","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Trois-Rivières","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Great Cambourne","state":"Cambridge","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Greater Manchester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Number of participants with adverse events (AEs)"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["aventura-florida","miami-florida","naples-florida","owensboro-kentucky","columbia-missouri","henderson-nevada","medford-oregon","spartanburg-south-carolina","cypress-texas","tomball-texas","buenos-aires-argentina","ciudad-autonoma-de-buenos-aire-argentina","lujan-de-cuyo-argentina","ajax-canada","qu-bec-canada","trois-rivi-res-canada","great-cambourne-united-kingdom","greater-manchester-united-kingdom"],"enrichment":{"headline":"Phase 3: testing HFA-152a for Asthma","inPlainEnglish":"This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).","whoItsFor":["Ages 18 Years to any","Participants with asthma for \\>= 6 months, defined as:","Documented history of asthma, as defined by Global Initiative for Asthma (GINA)","Receiving one of following asthma treatments for at least 12 weeks prior to the screening visit and which is anticipated to remain stable for the duration of the study:","Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only","Inhaled corticosteroid (ICS)/SABA prn only","SABA prn plus ICS prn","SABA prn plus ICS maintenance"],"whoShouldSkip":["Participants with a history of life-threatening asthma","Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening","Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis)","Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines","Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.)","Participants with exposure to more than four new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer","Participants with a known or suspected history of alcohol or drug abuse"],"whatHappens":"If you join, the listed intervention(s) are HFA-152a, or HFA-134a. The registry lists allocation as randomized. This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 110 people at 18 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.346Z"},{"nctId":"NCT07645287","title":"A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1","officialTitle":"A Phase 2 Randomized, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV-1","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35. In Part B the goal of the study is to compare the effectiveness of switching to the study drugs, GS-3242 and LEN versus continuing B/F/TAF in Groups 4 and 3 at Week 26.\n\nThe primary objective of part A is to evaluate the efficacy of switching to intramuscular (IM) GS-3242 plus IM LEN versus continuing on B/F/TAF PWH who are virologically suppressed in treatment Groups 1, 2, and 3 at Week 35 and Part B is to evaluate the efficacy of switching to IM GS-3242 plus IM LEN versus continuing on B/F/TAF in PWH who are virologically suppressed in Treatment Groups 4 and 3 at Week 26.","conditions":["HIV-1-infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"GS-3242 Tablet"},{"type":"DRUG","name":"GS-3242 Injection"},{"type":"DRUG","name":"Lenacapavir Tablet"},{"type":"DRUG","name":"Lenacapavir Injection"},{"type":"DRUG","name":"B/F/TAF"}],"enrollment":175,"startDate":"2026-06-15","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\< 50 copies/mL for ≥ 6 months before screening.\n* Plasma HIV-1 RNA levels \\< 50 copies/mL at screening.\n* Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening.\n* No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S).\n\nKey Exclusion Criteria:\n\n* Prior use of, or exposure to GS-3242 or LEN.\n* History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen.\n* Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Pueblo Family Physicians","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pacific Oak Medical Group","city":"Beverly Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ruane Clinical Research Group Inc.","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optimus Medical Group","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California San Francisco, Community and Clinical Research Center","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mills Clinical Research","city":"West Hollywood","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Clinical and Translational Research Center","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vivent Health","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midland Florida Clinical Research Center, LLC","city":"DeLand","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health Fort Lauderdale","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midway Immunology and Research Center","city":"Ft. Pierce","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AIDS Healthcare Foundation -Coconut Grove","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Floridian Clinical Research, LLC","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Immunology Center, PA","city":"Orlanda","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AHF - Pensacola","city":"Pensacola","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health Inc.","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triple O Research Institute, PA","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown Infectious Disease Clinic","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Infectious Disease Consultants, P.L.L.C.","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercer University, Department of Internal Medicine","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chatham County Health Department","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Well Medical Center","city":"Berkeley","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"KC CARE Health Center","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southampton Community Healthcare","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ID care","city":"Hillsborough","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Michael's Medical Center","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Jersey Infectious Disease","city":"Somers Point","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AXCES Research Group, LLC","city":"Sante Fe","state":"New Mexico","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brooklyn Clinical Research","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewYork-Presbyterian Queens","city":"Flushing","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health Vaccine Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montefiore Medical Center","city":"The Bronx","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Brody School of Medicine at East Carolina University","city":"Greenville","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rosedale Health and Wellness","city":"Huntersville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Philadelphia FIGHT Community Health Centers, Jonathan Lax Treatment Center","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Texas Clinical Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Hope Foundation","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prism Health North Texas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Texas Infectious Disease Consultants, P.A.","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AXCES Research Group, LLC","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Centers for Infectious Disease Associates","city":"Fort Worth","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Crofoot Research Center, INC.","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diagnostic Clinic of Longview","city":"Longview","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AXCES Research Group, LLC","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Alliance for Research& Education - Infectious Diseases, LLC(CARE-ID","city":"Annandale","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TribalMed PLLC","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MultiCare-Deaconess Medical Office Building 2","city":"Spokane","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taylor Square Private Clinic","city":"Surry Hills","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Clinical Research Darlinghurst","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Sydney Doctors","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prahran Market Clinic,","city":"South Yarra","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"CMU du Quartier Latin","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spectrum Health","city":"Vancouver","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proyecto ACTU","city":"Rio Piedras","state":"PR","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Puerto Rico","city":"San Juan","state":"PR","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOPE Clinical Research","city":"San Juan","state":"PR","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Part A: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm","Part B: Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["phoenix-arizona","beverly-hills-california","los-angeles-california","san-francisco-california","torrance-california","west-hollywood-california","aurora-colorado","denver-colorado","deland-florida","fort-lauderdale-florida","ft-pierce-florida","miami-florida","miami-lakes-florida","orlanda-florida","pensacola-florida","sarasota-florida","west-palm-beach-florida","atlanta-georgia","decatur-georgia","macon-georgia","savannah-georgia","berkeley-michigan","kansas-city-missouri","st-louis-missouri","hillsborough-new-jersey","newark-new-jersey","somers-point-new-jersey","sante-fe-new-mexico","brooklyn-new-york","flushing-new-york","new-york-new-york","the-bronx-new-york","greenville-north-carolina","huntersville-north-carolina","cincinnati-ohio","philadelphia-pennsylvania","austin-texas","bellaire-texas","dallas-texas","el-paso-texas","fort-worth-texas","houston-texas","longview-texas","salt-lake-city-utah","annandale-virginia","seattle-washington","spokane-washington","surry-hills-australia","sydney-australia","south-yarra-australia","montreal-canada","vancouver-canada","rio-piedras-puerto-rico","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 2: testing GS-3242 Tablet for HIV-1-infection","inPlainEnglish":"The study will have two parts: Part A and Part B. In Part A, the goal of the study is to compare the effectiveness of switching to the study drugs GS-3242 plus Lenacapavir (LEN) versus continuing Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in virologically suppressed people with HIV-1 (PWH) in treatment Group 1, 2 and 3 at Week 35.","whoItsFor":["Ages 18 Years to any","Documented human immunodeficiency virus type 1 (HIV-1) ribonucleic acid (RNA) \\< 50 copies/mL for ≥ 6 months before screening","Plasma HIV-1 RNA levels \\< 50 copies/mL at screening","Receiving bictegravir/emtricitabine/tenofovir alafenamide (coformulated; Biktarvy®) (B/F/TAF) for ≥ 6 months prior to screening","No documented resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S)"],"whoShouldSkip":["Prior use of, or exposure to GS-3242 or LEN","History of virologic failure while on an integrase strand transfer inhibitor (INSTI)-based regimen","Prior use of any long-acting parenteral antiretroviral therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are GS-3242 Tablet, GS-3242 Injection, or Lenacapavir Tablet. The registry lists allocation as randomized. The study will have two parts: Part A and Part B.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 175 people at 59 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.394Z"},{"nctId":"NCT07645352","title":"Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe","officialTitle":"Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fred Hutchinson Cancer Center","sponsorClass":"OTHER","summary":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.","conditions":["HIV (Human Immunodeficiency Virus)","HPV","Cervical Precancer","Cervical Neoplasia"],"keywords":["HIV","Cervical cancer screening","Treatment of Cervical Precancer","Thermal ablation","Human papillomavirus"],"interventions":[{"type":"PROCEDURE","name":"Thermal ablation (TA) with 1 probe"},{"type":"PROCEDURE","name":"Thermal ablation (TA) with 2 probes"}],"enrollment":300,"startDate":"2026-10-15","completionDate":"2027-12-31","sex":"FEMALE","minAge":"25 Years","maxAge":"49 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 25-49 years old\n2. Living with HIV\n\nInclusion criteria specific to the feasibility study\n\n1. Intact cervix\n2. Willing to return to facility at 6 months\n3. Willing and able to provide informed consent\n4. Positive hrHPV or VIA test within 3 months of enrollment\n5. Type 1 transformation zone (TZ1)\n6. Thermal ablation eligible\n\nExclusion Criteria:\n\n1. Screened for cervical cancer outside of study in last 6 months\n2. Currently pregnant or less than 6 weeks postpartum\n3. Prior diagnosis of cervical cancer\n4. A history of treatment for cervical precancer\n5. Total hysterectomy\n6. Currently receiving treatment for any cancer\n7. Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study\n8. Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled","locations":[{"facility":"University of Zimbabwe, Centre for Research","city":"Harare","state":"","country":"Zimbabwe","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Araceli Loera, MPH","phone":"+1 206-667-5816","email":"aloera@fredhutch.org"}],"primaryOutcomes":["Proportion of participants with persistent HPV at 6 months"],"hasResults":false,"conditionSlugs":["cervical-cancer","als","hiv"],"drugSlugs":[],"locationSlugs":["harare-zimbabwe"],"enrichment":{"headline":"Not a traditional drug phase: Thermal ablation (TA) with 1 probe for HIV (Human Immunodeficiency Virus)","inPlainEnglish":"Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its how well it works can be suboptimal in WLWH.","whoItsFor":["Ages 25 Years to 49 Years","Women only","who can join specific to the feasibility study","Willing to return to facility at 6 months","Positive hrHPV or VIA test within 3 months of enrollment","Type 1 transformation zone (TZ1)","Thermal ablation eligible"],"whoShouldSkip":["Screened for cervical cancer outside of study in last 6 months","Currently pregnant or less than 6 weeks postpartum","Prior diagnosis of cervical cancer","A history of treatment for cervical precancer","Currently receiving treatment for any cancer","Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study","Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled"],"whatHappens":"If you join, the listed intervention(s) are Thermal ablation (TA) with 1 probe, or Thermal ablation (TA) with 2 probes. The registry lists allocation as randomized. Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Harare. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.541Z"},{"nctId":"NCT07645820","title":"Evaluation of a Non-Invasive Device for Early Detection of Atopic Dermatitis Flares","officialTitle":"Evaluation of a Non-Invasive Device for Early Detection of Flares in Adults and Adolescents With Atopic Dermatitis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Castle Biosciences Incorporated","sponsorClass":"INDUSTRY","summary":"This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days. Participants will complete device measurements, electronic diary entries, and up to five in-person study visits. The study is based on the idea that changes in skin barrier function may occur before an AD flare becomes visible or symptoms begin. Information collected during the study, including device measurements, diary entries, and investigator assessments, will be used to evaluate whether these changes may help estimate the likelihood of an AD flare before visible signs or symptoms occur.","conditions":["Atopic Dermatitis"],"keywords":["Electrical Impedance Spectroscopy","EIS","Atopic Dermatitis","Eczema","Flare","Skin barrier function","Flare Prediction","Dermatology","Nevisense Go","Skin Barrier Dysfunction"],"interventions":[{"type":"DEVICE","name":"Nevisense electrical impedance spectroscopy"}],"enrollment":450,"startDate":"2026-06-04","completionDate":"2027-04-01","sex":"ALL","minAge":"12 Years","maxAge":"89 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nParticipants may be eligible if they:\n\n* Are 12 to 89 years old.\n* Have been diagnosed with atopic dermatitis (eczema).\n* Have had at least one atopic dermatitis flare within the past 2 months.\n* Are willing and able to use the Nevisense Go device at home, complete an electronic symptom diary, and attend study visits.\n* If currently using systemic treatment for atopic dermatitis, have been on the same treatment for at least 3 months and do not plan to change treatment during the study.\n\nExclusion Criteria:\n\nParticipants may not be eligible if they:\n\n* Are unwilling or unable to avoid applying creams, lotions, ointments, or soap to measurement areas for 6 hours before measurements.\n* Do not have suitable skin areas for study measurements.\n* Have another skin condition that may affect study assessments.\n* Are pregnant.","locations":[{"facility":"U.S. Dermatology Partners","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"James Y. Wang MD, Inc","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"True Blue Clinical Research","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"U.S. Dermatology Partners Rockville","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Derm Research Institute, PLC","city":"Caledonia","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"U.S. Dermatology Partners Lee's Summit","city":"Lee's Summit","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Dermatology and Cosmetic Surgery - Henderson","city":"Henderson","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Las Vegas Dermatology","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StracSkin, PLLC","city":"Portsmouth","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Skin Center Dermatology Group","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Columbus, OH","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DCOL Center for Clinical Research","city":"Longview","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Harrison Dermatology","city":"Missouri City","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jordan Valley Dermatology","city":"South Jordan","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Clinical Research, Inc","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia Research Institute","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clare Johnson E VP Clinical Research","phone":"602-499-0301","email":"cjohnson@castlebiosciences.com"}],"primaryOutcomes":["Relationship between skin measurements and subsequent atopic dermatitis flares","Develop and validate an algorithm using Nevisense Go EIS"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","los-angeles-california","tampa-florida","rockville-maryland","caledonia-michigan","lees-summit-missouri","henderson-nevada","las-vegas-nevada","portsmouth-new-hampshire","new-york-new-york","columbus-ohio","longview-texas","missouri-city-texas","south-jordan-utah","norfolk-virginia","morgantown-west-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Nevisense electrical impedance spectroscopy for Atopic Dermatitis","inPlainEnglish":"This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days.","whoItsFor":["Ages 12 Years to 89 Years","Participants may be eligible if they:","Are 12 to 89 years old","Have been diagnosed with atopic dermatitis (eczema)","Have had at least one atopic dermatitis flare within the past 2 months","Are willing and able to use the Nevisense Go device at home, complete an electronic symptom diary, and attend study visits","If currently using systemic treatment for atopic dermatitis, have been on the same treatment for at least 3 months and do not plan to change treatment during the study"],"whoShouldSkip":["Participants may not be eligible if they:","Are unwilling or unable to avoid applying creams, lotions, ointments, or soap to measurement areas for 6 hours before measurements","Do not have suitable skin areas for study measurements","Have another skin condition that may affect study assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 450 people at 16 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.816Z"},{"nctId":"NCT07645924","title":"A Study to Evaluate the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine","officialTitle":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"TriGemX Bio, Inc.","sponsorClass":"INDUSTRY","summary":"This is a double-blind, randomized, multicenter, outpatient evaluation of the efficacy, safety, and tolerability of elismetrep, as compared with placebo, in the acute treatment of migraine.","conditions":["Migraine"],"keywords":[],"interventions":[{"type":"DRUG","name":"Elismetrep"},{"type":"DRUG","name":"Placebo"}],"enrollment":1800,"startDate":"2026-07-01","completionDate":"2027-02","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent. 2. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:\n\na. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:\n\n1. A minimum of 12 months of spontaneous amenorrhea or\n2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \\> 40 mIU/mL or\n3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the participant's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.\n\nAcceptable methods of birth control are:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).\n3. Intrauterine device (IUD);\n4. Intrauterine hormone-releasing system (IUS);\n5. Bilateral tubal occlusion;\n6. Vasectomized partner;\n7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;\n8. Male or female condom with or without spermicide;\n9. Cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).\n\n5\\. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.\n\nExclusion Criteria:\n\nParticipants are excluded from the trial if any of the following criteria apply:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial.\n\n   Migraine history-related\n2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.\n3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.\n4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).\n5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.\n6. Was \\>50 years old at age of first migraine onset.\n7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.\n\n   Medical history related\n8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine \\[Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\\].\n9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.\n10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.\n11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.\n12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.\n13. Has a history of human immunodeficiency virus disease.\n14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption or may otherwise alter the absorption of orally administered drugs (e.g. upper gastrointestinal dysmotility).\n\n    Laboratory, vital sign, and electrocardiogram related\n15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.\n16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of \\<30 mL/min/1.73 m2.\n17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of \\>2.0 X upper limit of normal (ULN) or total bilirubin \\>1.5 X ULN at the Screening visit. Note: An isolated bilirubin \\>1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.\n18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) \\>450 ms for males and \\>470 ms for females at screening.\n19. Has a mean value for triplicate seated systolic blood pressure \\>160 mmHg and/or diastolic blood pressure \\>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.\n\n    Medication use and substance abuse related\n20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.\n21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol \\[THC\\] or cannabidiol \\[CBD\\] within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.\n22. Has a positive drug screen at screening. Note:\n\n    1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.\n    2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.\n23. Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol). Note: Any use of the following within 8 weeks of the screening visit, or anticipated use at any point during study participation are exclusionary:\n\n    1. Devices for the acute and/or preventative treatment of headache (migraine and/or other type of headache)\n    2. Nerve blocks and/or trigger point injections for the acute and/or preventative treatment of headache (migraine and/or other type of headache).\n24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.\n25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.\n26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.\n\n    Other\n27. Has known or suspected hypersensitivity to trial product(s) or related products.\n28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.\n29. Has any surgery scheduled for the duration of the trial.\n30. Has a screening hemoglobin \\<11.0 g/dL (males) or \\<10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).\n31. Has previous participation in this trial. Participation is defined as signed informed consent.\n32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P004. Note: Patients may not be screened at more than one trial site for this study.\n33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.\n34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site.","locations":[{"facility":"Central Research Associates, LLC (CRA) dba Flourish Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Mobile","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TrialSphere","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Clinical Research","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Research, LLC","city":"Colton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProScience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leading Edge Research LA, LLC","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Research, Orange County","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Downtown L.A. Research Center, Inc.","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research - Mission Mental Health (WR-MMH)","city":"Mission Viejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empire Clinical Research","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Neurology Group","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Acclaim Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Sherman Oaks CA (California Neuroscience Research)","city":"Sherman Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encompass Clinical Research","city":"Spring Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kinetic Clinical Research","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Focus Clinical Research","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMMUNOe Research Centers","city":"Centennial","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCB Clinical Research Centers","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Neurosciences Research","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chase Medical Research, LLC","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Drug Studies America","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge","city":"Stockbridge","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Crosse Research Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Headache Center & Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthcare Research Network II, LLC","city":"Flossmoor","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Headache Center & Research Institute","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integrated Clinical Trials Solution","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collective Medical Research","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Associates Midwest, LLC","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heartland Research Associates, LLC - An AMR Company","city":"Wichita","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)","city":"Bardstown","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTI Clinical Research Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crescent City Headache & Neurology Center","city":"Chalmette","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research - PharmaSite","city":"Pikesville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Clinical Trials - 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Lewis Research, Inc. / Foothill Family Clinic Draper","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Granger Medical Clinic","city":"Riverton","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"J. Lewis Research, Inc. / Foothill Family Clinic","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Research of Hampton Roads, Inc. (HRHR)","city":"Newport News","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Norfolk","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Clinical Research Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Investigation Specialists, Inc.","city":"Kenosha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Annemarie Vance","phone":"917-336-3654","email":"annemarie@kallyope.com"}],"primaryOutcomes":["Pain freedom at 2 hours post-dose","Freedom from most bothersome symptoms (MBS) at 2 hours post-dose"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","mobile-alabama","chandler-arizona","little-rock-arkansas","colton-california","culver-city-california","encino-california","irvine-california","los-angeles-california","mission-viejo-california","oceanside-california","pomona-california","riverside-california","san-diego-california","sherman-oaks-california","spring-valley-california","walnut-creek-california","west-covina-california","west-hills-california","centennial-colorado","colorado-springs-colorado","fort-collins-colorado","waterbury-connecticut","atlanta-georgia","marietta-georgia","stockbridge-georgia","chicago-illinois","flossmoor-illinois","naperville-illinois","west-des-moines-iowa","overland-park-kansas","wichita-kansas","bardstown-kentucky","lexington-kentucky","chalmette-louisiana","new-orleans-louisiana","pikesville-maryland","boston-massachusetts","waltham-massachusetts","ann-arbor-michigan","minneapolis-minnesota","gulfport-mississippi","ridgeland-mississippi","city-of-saint-peters-missouri","hazelwood-missouri","kansas-city-missouri","springfield-missouri","st-louis-missouri","las-vegas-nevada","north-las-vegas-nevada","reno-nevada","albuquerque-new-mexico","amherst-new-york","brooklyn-new-york","commack-new-york","manlius-new-york","new-york-new-york","rochester-new-york","williamsville-new-york","charlotte-north-carolina","greensboro-north-carolina","raleigh-north-carolina","shelby-north-carolina","columbus-ohio","milford-ohio","west-chester-ohio","edmond-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","yukon-oklahoma","portland-oregon","allentown-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","scottdale-pennsylvania","smithfield-pennsylvania","north-charleston-south-carolina","chattanooga-tennessee","nashville-tennessee","austin-texas","cypress-texas","dallas-texas","houston-texas","lampasas-texas","plano-texas","waxahachie-texas","bountiful-utah","draper-utah","ogden-utah","riverton-utah","salt-lake-city-utah","newport-news-virginia","norfolk-virginia","seattle-washington","morgantown-west-virginia","kenosha-wisconsin"],"enrichment":{"headline":"Phase 3: testing Elismetrep for Migraine","inPlainEnglish":"This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, multicenter, outpatient evaluation of the how well it works, safety, and tolerability of elismetrep, as compared with dummy treatment (placebo), in the acute treatment of migraine.","whoItsFor":["Ages 18 Years to 75 Years","a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:","A minimum of 12 months of spontaneous amenorrhea or","A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \\> 40 mIU/mL or","Acceptable methods of birth control are:","Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)","Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable)","Intrauterine device (IUD);"],"whoShouldSkip":["Participants are excluded from the trial if any of the following criteria apply:","Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the trial","Migraine history-related","Has difficulty distinguishing his/her migraine attacks from tension-type headaches","Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours","Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1)","Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine"],"whatHappens":"If you join, the listed intervention(s) are Elismetrep, or Placebo. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, multicenter, outpatient evaluation of the how well it works, safety, and tolerability of elismetrep, as compared with dummy treatment (placebo), in the acute treatment of migraine.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,800 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.294Z"},{"nctId":"NCT07646613","title":"Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"Aspeya, Inc.","sponsorClass":"INDUSTRY","summary":"This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.\n\nFollowing screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.\n\nThe study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.","conditions":["Migraine"],"keywords":["Migraine","DHE","Dihydroergotamine Mesylate"],"interventions":[{"type":"COMBINATION_PRODUCT","name":"ASY202"},{"type":"COMBINATION_PRODUCT","name":"Placebo"}],"enrollment":108,"startDate":"2026-05-19","completionDate":"2027-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to understand study procedures and provide written informed consent\n* Male or female, 18-65 years of age at Screening\n* BMI between 18.5-35 kg/m² at Screening\n* Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)\n* Female participants must be either:\n\n  * of non-childbearing potential, or\n  * of childbearing potential using protocol required contraception\n\nExclusion Criteria:\n\n* Diagnosis of headache conditions other than migraine\n* History or current diagnosis of coronary artery disease (CAD)\n* History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)\n* History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery\n* History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage\n* Known history or current diagnosis of psychological and/or psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.\n* Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation\n* Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization\n* Any clinically significant symptoms or conditions at screening, other than migraine, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions, or history of such conditions that in the opinion of the Investigator, might interfere with study assessments or participant safety","locations":[{"facility":"Arizona Research Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy San Diego","city":"Lemon Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research, Llc","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Institute for Clinical Research","city":"Stamford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chase Medical Research","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscineces Solutions - Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscineces Solutions","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Clinical Trials","city":"Roslindale","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mass. Institute of Clinical Research","city":"Westborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research - Las Vegas Rainbow","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Marlton NJ","city":"Marlton","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SPRI Clinical Trials","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Associates, Inc.","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highland Clinical Research","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eken","phone":"+41 76 358 88 30","email":"clinicaltrials@aspeya.com"}],"primaryOutcomes":["Proportion of patients with freedom from headache pain at 2 hours post-dose"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","lemon-grove-california","walnut-creek-california","stamford-connecticut","waterbury-connecticut","orlando-florida","atlanta-georgia","roslindale-massachusetts","westborough-massachusetts","city-of-saint-peters-missouri","las-vegas-nevada","marlton-new-jersey","brooklyn-new-york","raleigh-north-carolina","memphis-tennessee","nashville-tennessee","austin-texas","dallas-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 2: ASY202 for Migraine","inPlainEnglish":"This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a dummy treatment (placebo) (inactive treatment) at different times during the study.","whoItsFor":["Ages 18 Years to 65 Years","Male or female, 18-65 years of age at Screening","body-mass index (BMI) between 18.5-35 kg/m² at Screening","Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)","Female participants must be either:","of non-childbearing potential, or","of childbearing potential using protocol required contraception"],"whoShouldSkip":["Diagnosis of headache conditions other than migraine","History or current diagnosis of coronary artery disease (CAD)","History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery","History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage","Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation","Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization"],"whatHappens":"If you join, the listed intervention(s) are ASY202, or Placebo. The registry lists allocation as randomized. This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 108 people at 20 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.308Z"},{"nctId":"NCT07648329","title":"Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation","officialTitle":"Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre Hospitalier Universitaire Dijon","sponsorClass":"OTHER","summary":"trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality. Characterized by rapid, irregular, and weakened contractions of the atria, AF is considered one of the \"visible\" electrophysiological manifestations of a broader condition known as atrial cardiomyopathy (ACM). Disruption of normal blood flow in the atrium, particularly in the context of an endocardium predisposed to thrombosis, predisposes to thrombus formation. Once dislodged from the atrial cavity and migrating to the cerebral arteries, these thrombi can cause a cardioembolic stroke. The main risk factors for ACI/AF are metabolic syndrome and aging. CMA is a condition that is difficult to diagnose because it is not clearly defined, except through histological analysis. Guided by the results of our experimental approaches, we aim to address this challenge by approaching CMA through one of its complications: persistent atrial fibrillation. Indeed, CMA can be assessed using electroanatomical mapping during atrial fibrillation ablation (AFA) procedures. During radiofrequency ablation of AF, electroanatomical mapping of the left atrium is performed to measure left atrial voltage, which serves as an indirect marker of the presence of atrial fibrosis, strongly associated with CMA. Other parameters relevant to the identification of CMA can be assessed during this procedure, such as conduction velocities and specific electrographic characteristics.\n\nWe plan to include 150 patients undergoing ablation for persistent atrial fibrillation at the Dijon Bourgogne University Hospital and to correlate circulating levels of BDNF (brain-derived neurotrophic factor) with electroanatomical mapping data of the left atrium. The electrical remodeling of the left atrium, including low-voltage areas and conduction velocity, as well as left atrial morphology assessed by pre-procedural cardiac computed tomography using the ADAS3 Galgo LA Module software, will be correlated with BDNF levels. Blood samples for BDNF assessment will be collected before or at the start of the ablation procedure, prior to any catheter insertion into the vessels.\n\nWhile investigating the association between BDNF levels and CMA characteristics during AF ablation, thereby confirming the pathophysiological relationship with atrial remodeling, our objective is also to evaluate the prognostic role of BDNF levels in clinical and rhythm outcomes following AF ablation. Thus, we will compare changes in BDNF levels after AF ablation at one-year follow-up, correlating them with the evolution of CMA-based on left atrial parameters assessed by echocardiography or cardiac computed tomography-autonomic nervous system balance and heart rhythm obtained via Holter monitoring, as well as clinical outcomes.","conditions":["Atrial Fibrillation (AF)","Cardiac Arrhythmia","Atrial Fibrillation Ablation","BDNF","Atrial Cardiomyopathy"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"blood draw"},{"type":"PROCEDURE","name":"CT scan"}],"enrollment":150,"startDate":"2026-10-20","completionDate":"2029-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants who have provided written consent\n* Patients aged 18 years or older.\n* Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital\n\nExclusion Criteria:\n\n* A person who is not enrolled in or eligible for a social security program\n* A person subject to a legal protective measure (guardianship, conservatorship)\n* Person subject to a judicial safeguard measure\n* Pregnant or breastfeeding woman\n* Adult who is legally incapacitated or unable to give consent\n* Ablation of paroxysmal AF with or without electroanatomical mapping","locations":[{"facility":"Chu Dijon Bourogne","city":"Dijon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Charles GUENANCIA","phone":"03.80.29.56.23","email":"charles.guenancia@chu-dijon.fr"}],"primaryOutcomes":["First recurrence of AF between 3 and 12 months following an initial ablation for persistent AF"],"hasResults":false,"conditionSlugs":["als","stroke","heart-failure","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["dijon-france"],"enrichment":{"headline":"Not a traditional drug phase: testing blood draw for Atrial Fibrillation (AF)","inPlainEnglish":"Trial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and its prevalence continues to rise. AF is associated with serious complications, including embolic strokes, heart failure, and mortality.","whoItsFor":["Ages 18 Years to any","Participants who have provided written consent","Patients aged 18 years or older","Patients scheduled to undergo their first ablation procedure for persistent atrial fibrillation at the Dijon Bourgogne University Hospital"],"whoShouldSkip":["A person who is not enrolled in or eligible for a social security program","A person subject to a legal protective measure (guardianship, conservatorship)","Person subject to a judicial safeguard measure","Pregnant or breastfeeding woman","Ablation of paroxysmal AF with or without electroanatomical mapping"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Dijon. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.751Z"},{"nctId":"NCT07649265","title":"A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body","officialTitle":"A Phase 1 Open-Label, Multicenter Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HBM7020 in Healthy Adult Participants and Adults With Seropositive Autoimmune Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsorClass":"INDUSTRY","summary":"This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement. Eligible participants include patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), Sjögren's disease (SjD), and rheumatoid arthritis (RA).","conditions":["Rheumatoid Arthritis","Systemic Lupus Erythematosus","Systemic Sclerosis","Sjögren's Disease"],"keywords":["Autoimmune disease"],"interventions":[{"type":"DRUG","name":"HBM7020"}],"enrollment":63,"startDate":"2026-09-24","completionDate":"2028-11-20","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"Key Inclusion Criteria for Healthy Participants (Part 1)\n\n1. Participants who are of non-childbearing potential or are using acceptable contraception.\n2. Body mass index (BMI) and body weight within an acceptable range.\n3. Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments.\n\nKey Disease-Agnostic Inclusion Criteria for Patient Participants (Part 2)\n\n1. BMI and body weight within an acceptable range.\n2. Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters.\n\nKey Disease-Specific Inclusion Criteria for Patient Participants (Part 2)\n\n1. Confirmed autoimmune disease with appropriate supporting autoantibody findings.\n2. Stable background therapy prior to dosing.\n3. Active moderate to severe disease consistent with protocol-defined disease activity criteria for:\n\n   * Systemic lupus erythematosus (SLE)\n   * Systemic sclerosis (SSc)\n   * Rheumatoid arthritis (RA)\n   * Sjögren's disease (SjD)\n\nKey Inclusion Criteria for Rescreening Participants (Part 2)\n\n1. Meets Part 2 disease-agnostic inclusion criteria.\n2. Stable background autoimmune therapy prior to dosing.\n3. Ongoing active moderate to severe disease based on protocol-defined disease-specific criteria.\n\nKey Exclusion Criteria for Parts 1 and 2\n\n1. Pregnant or breastfeeding participants.\n2. Recent vaccination within protocol-defined timelines.\n3. Clinically significant medical history or abnormal physical examination findings.\n4. Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings.\n5. Prior or recent therapies or conditions that may interfere with study participation or safety evaluations.\n6. Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension.","locations":[{"facility":"Q-Pharm Pty Ltd","city":"Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Otsuka Call Center","phone":"844-687-3522","email":"otsukaprofessionalservices@otsuka-us.com"}],"primaryOutcomes":["Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Study Discontinuations Due to Adverse Events Through Week 48","Number of Participants With Signs Characteristic of Cytokine Release Syndrome (CRS), Immune Related Reaction (IRR), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), Including Immunosuppression-Related Infection","Number of Participants With Dose limiting AE Evaluation During Dose Escalation","Number of Participants With Clinically Significant Changes in Vital Signs","Number of Participants With Clinically Significant Changes in Physical Examination Findings","Change From Baseline in Serum High Sensitivity C-Reactive Protein (hsCRP)","Change From Baseline in Serum Erythrocyte Sedimentation Rate (ESR)","Change From Baseline in Serum Ferritin","Change From Baseline in Serum Immunoglobulin G (IgG)"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["brisbane-australia"],"enrichment":{"headline":"Phase 1: testing HBM7020 for Rheumatoid Arthritis","inPlainEnglish":"This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020. The study will enroll healthy participants at low doses, followed by participants with moderate to severe autoimmune diseases with predominant B-cell involvement.","whoItsFor":["Ages 18 Years to 75 Years","Key for Healthy Participants (Part 1)","Participants who are of non-childbearing potential or are using acceptable contraception","Body mass index (body-mass index (BMI)) and body weight within an acceptable range","Good general health based on medical history, physical examination, electrocardiogram (ECG), and laboratory assessments","Key Disease-Agnostic who can join for Patient Participants (Part 2)","body-mass index (BMI) and body weight within an acceptable range","Adequate hematologic, renal, hepatic, immunologic, and lymphocyte parameters"],"whoShouldSkip":["Pregnant or breastfeeding participants","Recent vaccination within protocol-defined timelines","Clinically significant medical history or abnormal physical examination findings","Clinically significant cardiovascular abnormalities, including blood pressure, heart rate, syncope, or ECG findings","Prior or recent therapies or conditions that may interfere with study participation or safety evaluations","Severe pulmonary, renal, or cardiac disease, or clinically significant pulmonary hypertension"],"whatHappens":"If you join, the listed intervention(s) are HBM7020. The registry lists allocation as randomized. This first-in-human study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of HBM7020.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 63 people at Brisbane. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.953Z"},{"nctId":"NCT07649304","title":"AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The \"Glofit-RCHOP Study\")","officialTitle":"A Feasibility Study of Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time. This may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving glofitamab in combination with the R-CHOP regimen may be a safe treatment for patients with newly-diagnosed with HIV-associated large B-cell lymphoma.","conditions":["AIDS-Related Diffuse Large B-cell Lymphoma","Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements","High Grade B-Cell Lymphoma, Not Otherwise Specified","Lugano Classification Stage II Adult Non-Hodgkin Lymphoma AJCC v8","Lugano Classification Stage III Adult Non-Hodgkin Lymphoma AJCC v8","Lugano Classification Stage IV Adult Non-Hodgkin Lymphoma AJCC v8","Plasmablastic Lymphoma","Primary Effusion Lymphoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"DRUG","name":"Cyclophosphamide"},{"type":"DRUG","name":"Doxorubicin Hydrochloride"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"BIOLOGICAL","name":"Glofitamab"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"DRUG","name":"Prednisone"},{"type":"OTHER","name":"Questionnaire Administration"},{"type":"BIOLOGICAL","name":"Rituximab"},{"type":"DRUG","name":"Vincristine Sulfate"}],"enrollment":15,"startDate":"2027-07-05","completionDate":"2028-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant is able to understand and willing to sign a written informed consent document\n* Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive newly diagnosed HIV-associated LBCL as per World Health Organization (WHO) 5th edition, diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B-cell lymphoma-NOS or DLBCL/high grade B-cell lymphoma with MYC and BCL2 rearrangement. Plasmablastic lymphoma and primary effusion lymphoma may be included only if CD20-positive\n* Stage II-IV disease (as per Lugano Staging Criteria) that is measurable as defined below:\n\n  * Measurable lymph nodes with longest diameter \\> 1.5 cm, or\n  * Measurable extranodal lesions with longest diameter \\> 1.0 cm\n  * Participants with bone marrow involvement only will be eligible as long as the morphological bone marrow involvement is documented on a bone marrow biopsy. These participants, however, will need to be willing to undergo subsequent bone marrow biopsies for response assessment and documentation\n* Evidence of HIV infection. Participants must have documentation of HIV-1 infection by means of any one of the following:\n\n  * Documentation of HIV diagnosis in the medical record by a licensed health care provider;\n  * Documentation of receipt of ART (at least two different medications that do not constitute a prescription for pre-exposure prophylaxis) by a licensed health care provider. Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name;\n  * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay at any time;\n  * Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.\n\n    * Note: The term \"licensed\" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., United States \\[US\\] Food and Drug Administration \\[FDA\\]).\n\nWorld Health Organization and Centers for Disease Control and Prevention guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.\n\n* Participants with HIV must be on treatment with effective ART that is in accordance with the current International AIDS Society guidelines concurrently with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine (including Combivir and Trizivir) or ritonavir (includes Norvir® or Kaletra®), cobicistat, didanosine (Videx® or Videx EC®), or similar potent CYP3 inhibitors are prohibited. In order to be eligible, participants taking zidovudine or ritonavir, cobicistat, didanosine, or other CYP3 inhibitors must change to a different regimen 7 days prior to protocol therapy initiation. Changes to ART therapy during the study may be made if medically necessary (toxicity, failure of regimen, etc.). Participants must be on ART for at least 7 days prior to initiation of protocol therapy except for ART-naïve participants who need to get started on ART within the 1st cycle of study treatment (before cycle 2 day 1). ART needs to be approved by protocol chair or co-chair prior to enrollment\n* Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in participants \\< 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥50%)\n* Absolute neutrophil count (ANC) ≥ 1,000/mcL unless decreased due to bone marrow involvement. Also, in participants with the Duffy antigen null phenotype, neutrophil counts may be lower and a lower threshold required for enrollment can be discussed with the protocol chair on a case-by-case basis\n* Platelets ≥ 75,000/mcL unless decreased due to bone marrow involvement\n* Hemoglobin of ≥ 8 g/dL unless decreased due to bone marrow involvement\n* Aspartate aminotransferase (AST \\[serum glutamic oxaloacetic transaminase (SGOT)\\])/alanine aminotransferase (ALT \\[serum glutamate pyruvate transaminase (SGPT)\\]) ≤ 3 × institutional upper limit of normal (ULN; ≤ 5 × ULN is acceptable if secondary to liver involvement by lymphoma)\n* Total serum bilirubin ≤ 1.5 × institutional ULN (\\< 3.0 × ULN for participants with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to ART, the total bilirubin must be ≤ 3.5 mg/dL, provided that the direct bilirubin is normal and the AST and ALT ≤ 3 x the ULN\n* Glomerular filtration rate (GFR) no lower than 30 mL/min/1.73 m\\^2. GFR can be measured directly or estimated using the site's institutional standards\n* Participants must have adequate cardiac function defined as a left ventricular ejection fraction of at least 45% as determined by echocardiogram or multigated acquisition within 6 weeks before enrollment\n* The effects of glofitamab on the developing human fetus are unknown. For this reason and because CD20/CD3 bispecific antibodies, as well as other therapeutic agents used in this trial, are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; total abstinence) from study entry and for at least 1 months from the last glofitamab administration or 12 months from the last rituximab administration, whichever is the longest. Women of childbearing potential, defined as pre- or perimenopausal females with an intact uterus, must have a negative serum β-HCG within 7 days prior to enrollment. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately. Men treated with glofitamab must also agree to use adequate contraception with partners who are women of childbearing potential (condom plus an additional contraceptive method, such as bilateral tubal occlusion, male sterilization, hormone-releasing intrauterine devices, and copper intrauterine devices) or use contraceptive measures such as a condom with pregnant female partners to avoid exposing the embryo during intercourse, from study entry, for the duration of study participation, and 1 months after the last glofitamab dose or 12 months after completion of rituximab administration, whichever is the longest\n* Any CD4 count is allowed\n* Participants with leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required during the first cycle of therapy, except during the initial safety run-in phase, during which participants with leptomeningeal disease will be excluded. For the first three study participants, enrollment will be halted until the third participant completes two target doses (30 mg) of glofitamab and dose-limiting toxicity (DLT) assessment is completed\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n\nExclusion Criteria:\n\n* Participants who are receiving any other investigational agents\n* Participants with active parenchymal central nervous system (CNS) lymphomatous involvement are excluded; however, asymptomatic leptomeningeal disease is allowed as long as participants have ongoing CNS directed therapy, except during the initial safety-run in phase, during which participants with leptomeningeal disease will also be excluded\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study\n* Uncontrolled intercurrent illness including, but not limited to: symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (including, but not limited to clinically significant obstructive pulmonary disease or history of bronchospasm), clinically significant liver disease (including viral or other hepatitis or cirrhosis) or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements or make participation in this protocol unreasonably hazardous\n* Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with the study agent(s), breastfeeding should be discontinued if the mother is treated with the study agent(s). These potential risks may also apply to other agents used in this study\n* Participants with refractory HIV disease will not be eligible. Refractory HIV will be defined as prior ART exposure and HIV viral load \\> 1000 copies/uL and no options for HIV control evaluated by HIV genotyping. Participants with HIV viral load \\> 1000 copies/uL can be enrolled if additional ART will be initiated\n* Participants who have had chemotherapy other than allowable pre-trial therapy outlined below, or radiotherapy other than palliative radiation for medical emergencies (i.e., cord compression or impending fracture), within the last four weeks.\n\n  * Allowable prior therapy:\n\n    * A maximum of one cycle of combination chemotherapy, including CHOP ± rituximab and etoposide-prednisone-Oncovin-cyclophosphamide-hydroxydaunorubicin (EPOCH) ± rituximab. The start of previous chemotherapy cycle must occur at least 21 days but no more than 35 days prior to beginning treatment under this protocol, and this cycle will count towards the maximum of six cycles under this study (i.e., cycle received prior to study enrollment will count as cycle 1) OR\n    * One prior course of limited therapy including cyclophosphamide and/or glucocorticoids and/or rituximab to improve fitness for combination chemotherapy (i.e., those with impaired hepatic function, renal function and or performance status due to lymphomatous involvement). The start of this therapy may occur up to 35 days prior to beginning treatment under this protocol; cyclophosphamide administration must have been completed at least 14 days prior to initiation of protocol therapy. Such treatment will not count towards the maximum of six cycles under this study (i.e., participants will receive six cycles on study and start with cycle 1 of RCHOP)\n* Participants must not have had previous anthracycline treatment within the last two years, except for one cycle off protocol or liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the left ventricular ejection fraction is ≥ 45%. It is at the discretion of the investigator if prior exposure to doxorubicin more than two years prior is acceptable\n* Known active bacterial, viral (HIV infection allowed), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 4 weeks before the start of cycle 1\n* Participants with chronic hepatitis B (defined by a positive test for hepatitis B surface antigen \\[HBsAg\\]). All participants will be required to be screened for Hepatitis B. Participants with resolved infection (i.e., participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen \\[anti-HBc\\] and/or antibodies to hepatitis B surface antigen \\[anti-HBs\\]) must be screened using real-time polymerase chain reaction (PCR) measurement of Hepatitis B virus (HBV) DNA levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. For participants who have evidence of prior Hepatitis B exposure and are PCR negative, hepatitis B (Hep B) reactivation prophylaxis is mandated using institutional guidelines\n* If hepatitis C antibody positive, participants will be excluded from study unless hepatitis C viral load is undetectable. Additionally, participants must have no evidence of cirrhosis and have liver function tests (LFTs)\n* Participants with baseline peripheral neuropathy \\> grade 2 or painful \\>/= grade 2 neuropathy\n* Participants who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Concomitant medications: Participants should only be excluded from trial participation when clinically relevant known or predicted drug-drug interactions or potential overlapping toxicities will impact safety or efficacy. Please include scientific or clinically based rationale for exclusion.\n\n  * Please note that this must account for all agents to be used on this study, including commercial agents. Please refer to the FDA product labels for all commercial agents and include information on prohibited concomitant medications in all applicable sections of the protocol\n  * A wash out period prior to the start of cycle 1 of at least 4 weeks for prior use of any monoclonal antibody, systemic immunotherapeutic agents, immunosuppressive agents (such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) is required\n* Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the principal investigator (PI). Participants with impaired decision-making capacity (IDMC) with a legally authorized representative (LAR) may be included if they fulfill all other eligibility requirements.\"\n* Major surgery, other than diagnostic surgery, occurring within 4 weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery\n* Having received a live, attenuated vaccine within 28 days prior to registration\n* Myocardial infarction within the preceding 3 months\n* Prior solid organ or allogeneic hematopoietic cell transplant\n* Prior diagnosis of progressive multifocal leukoencephalopathy (PML)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following exceptions apply:\n\n  * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone\n  * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for study\n  * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases\n  * Participants with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., participants with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n    * Rash must cover \\< 10% of body surface area\n    * Disease is well controlled at baseline and requires only low-potency topical corticosteroids","locations":[{"facility":"AIDS Malignancy Consortium","city":"Rockville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Ability to deliver at least 4 full cycles of glofitamab-rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (Glofit-RCHOP) (Feasibility)"],"hasResults":false,"conditionSlugs":["lymphoma","als","hiv"],"drugSlugs":[],"locationSlugs":["rockville-maryland"],"enrichment":{"headline":"Phase 1: testing Cyclophosphamide for AIDS-Related Diffuse Large B-cell Lymphoma","inPlainEnglish":"This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma. Glofitamab is a bispecific monoclonal antibody, which can bind to two different antigens that are expressed by cancer cells (CD3 and CD20) at the same time.","whoItsFor":["Ages 18 Years to any","Stage II-IV disease (as per Lugano Staging Criteria) that is measurable as defined below:","Measurable lymph nodes with longest diameter \\> 1.5 cm, or","Measurable extranodal lesions with longest diameter \\> 1.0 cm","Evidence of HIV infection. Participants must have documentation of HIV-1 infection by means of any one of the following:","Documentation of HIV diagnosis in the medical record by a licensed health care provider;","HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay at any time;","Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay"],"whoShouldSkip":["Participants who are receiving any other investigational agents","History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study","Participants who have had chemotherapy other than allowable pre-trial therapy outlined below, or radiotherapy other than palliative radiation for medical emergencies (i.e., cord compression or impending fracture), within the last four weeks","Allowable prior therapy:","Known active bacterial, viral (HIV infection allowed), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 4 weeks before the start of cycle 1","If hepatitis C antibody positive, you would be excluded from study unless hepatitis C viral load is undetectable. Additionally, participants must have no evidence of cirrhosis and have liver function tests (LFTs)","Participants with baseline peripheral neuropathy \\> grade 2 or painful \\>/= grade 2 neuropathy"],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Bone Marrow Aspiration. The registry lists allocation as na. This phase I trial studies the safety and side effects of glofitamab plus a chemoimmunotherapy regimen called R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in treating patients newly-diagnosed with HIV-associated large B-cell lymphoma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 15 people at Rockville. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.532Z"},{"nctId":"NCT07650448","title":"WATER IV PCa (AS Sub-study)","officialTitle":"WATER IV Prostate Cancer: Aquablation Versus Active Surveillance for the Treatment of Localized Prostate Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"PROCEPT BioRobotics","sponsorClass":"INDUSTRY","summary":"The WATER IV study is a multicenter, prospective, randomized clinical trial that aims to evaluate the safety and efficacy of Aquablation therapy in men with localized prostate cancer.","conditions":["Localized Prostate Cancer"],"keywords":["Aquablation","AquaBeam","HYDROS","Active Surveillance","Prostate Cancer","Aquablation Therapy"],"interventions":[{"type":"DEVICE","name":"Aquablation Therapy"},{"type":"OTHER","name":"Active Surveillance"}],"enrollment":333,"startDate":"2026-09-11","completionDate":"2028-12","sex":"MALE","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Biological male with age ≥ 45 years at the time of consent\n2. Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)\n3. First prostate cancer diagnoses within 18 months (545 days) of consent\n4. Are candidates for active surveillance\n5. Clinical Stage ≤ T2c\n6. PSA \\< 15 ng/ml\n7. Prostate volume ≥25 ml\n\nExclusion Criteria:\n\n1. Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy.\n2. Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment.\n3. Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion.\n4. Patient is unwilling to accept a blood transfusion if required.\n5. Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:\n\n5a. Medical conditions that preclude the use of anesthesia; 5b. Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of rectal injury (i.e. fistula formation); 5c. Patient is unable to stop anticoagulants or antiplatelet agents prior to study treatment per standard of care; 5d. Any other condition or history of infection, illness or surgery that in the opinion of the investigator might affect the outcome of the study procedure, study conduct, and study results; or pose additional risks to the patient (e.g., other cancer, active urethral stricture disease).\n\n6\\. Patients who are unable to provide informed consent due to cognitive impairment, legal status (such as incarceration), or other factors limiting autonomy or unwilling or unable to follow study instructions including randomization and complete all required study visits through 10 years. This includes individuals with severe cognitive disabilities, those under legal guardianship, or those currently incarcerated.\n\n7\\. Patient currently participating in other studies unless approved by Sponsor in writing.\n\n8\\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3).\n\n9\\. GG2 disease with PSA ≥ 10 OR stage ≥ T2b OR ≥ 50% of biopsy cores positive (multiple cores taken from any MRI visible lesion are counted as one continuous core).","locations":[{"facility":"Arizona State Urological Institute","city":"Chandler","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Southern California","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tri Valley Urology","city":"Murrieta","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boulder Medical Center","city":"Boulder","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research","city":"Delray Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Trophy Point Urology","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Georgia Urology","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mountain View Hospital","city":"Idaho Falls","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Endeavor Health","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United 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States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Rochester Medical Center","city":"Rochester","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic Foundation","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"MUSC Hollings Cancer Center","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tidelands Health Urology","city":"Murrells Inlet","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Midtown Urology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Urology Clinics of 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2"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["chandler-arizona","los-angeles-california","murrieta-california","boulder-colorado","delray-beach-florida","miami-florida","tampa-florida","atlanta-georgia","idaho-falls-idaho","chicago-illinois","glenview-illinois","baltimore-maryland","north-kansas-city-missouri","kearney-nebraska","omaha-nebraska","hackensack-new-jersey","albany-new-york","new-york-new-york","rochester-new-york","cleveland-ohio","charleston-south-carolina","murrells-inlet-south-carolina","austin-texas","dallas-texas","alexandria-virginia","sheboygan-wisconsin","shatin-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: Aquablation Therapy for Localized Prostate Cancer","inPlainEnglish":"The WATER IV study is a multicenter, prospective, randomly assigned clinical trial that aims to measure the safety and how well it works of Aquablation therapy in men with localized prostate cancer.","whoItsFor":["Ages 45 Years to any","Men only","Biological male with age ≥ 45 years at the time of consent","Biopsy positive Grade Group 2 prostate cancer or biopsy positive Grade Group 1 MRI visible lesion (PI-RADS/Likert ≥ 3)","First prostate cancer diagnoses within 18 months (545 days) of consent","Are candidates for active surveillance","Clinical Stage ≤ T2c","Prostate volume ≥25 ml"],"whoShouldSkip":["Any prior or current local or systemic treatment for prostate cancer, including but not limited to surgery, radiation therapy (external or brachytherapy), tissue ablation, hormone therapy or chemotherapy","Patients with previous surgical or minimally invasive treatment of benign prostatic hyperplasia within the prior 3 months of study treatment","Evidence of lymph node, bone metastasis, extracapsular extension or seminal vesicle invasion","Patient is unwilling to accept a blood transfusion if required","Any condition or history of illness or surgery that may pose an additional risk to patients undergoing the Aquablation or radical prostatectomy procedure such as:","7\\. Patient currently participating in other studies unless approved by Sponsor in writing","8\\. More than one complete biopsy beyond the diagnostic biopsy comprising both a systematic biopsy and biopsy of any MRI visible lesion (PI-RADS/Likert ≥ 3)"],"whatHappens":"If you join, the listed intervention(s) are Aquablation Therapy, or Active Surveillance. The registry lists allocation as randomized. The WATER IV study is a multicenter, prospective, randomly assigned clinical trial that aims to measure the safety and how well it works of Aquablation therapy in men with localized prostate cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 333 people at 28 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.318Z"},{"nctId":"NCT07650916","title":"A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed","officialTitle":"A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"ViiV Healthcare","sponsorClass":"INDUSTRY","summary":"This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).","conditions":["HIV"],"keywords":["Cabotegravir","Rilpivirine","HIV","Non-inferiority","Efficacy","Safety","Tolerability"],"interventions":[{"type":"DRUG","name":"CAB ULA"},{"type":"DRUG","name":"RPV ULA"},{"type":"DRUG","name":"CAB LA"},{"type":"DRUG","name":"RPV LA"}],"enrollment":564,"startDate":"2026-06-25","completionDate":"2029-08-13","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\nPatient Study Participant (PSP) Inclusion criteria\n\n* Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg.\n* Documented HIV-1 RNA measurements \\<50 copies/mL in the 12 months prior to Screening.\n* HIV-1 RNA \\<50 copies/mL at screening assessment.\n* Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening.\n* Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL).\n\nExclusion criteria:\n\nPatient Study Participant (PSP) Exclusion criteria\n\n* Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation\n* Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening\n* Any history of receiving long-acting therapy for treatment or prevention of HIV\n* Previous exposure to injectable CAB and/or injectable RPV for treatment or prevention of HIV-1 infection\n* Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"GSK Investigational Site","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"West Hollywood","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"DeLand","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Ft. 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Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Vigo Pontevedra","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Birmingham","state":"West Midlands","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Liverpool","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","bakersfield-california","los-angeles-california","san-diego-california","west-hollywood-california","new-haven-connecticut","washington-d-c-district-of-columbia","deland-florida","fort-lauderdale-florida","ft-pierce-florida","jacksonville-florida","miami-florida","orlando-florida","pensacola-florida","vero-beach-florida","west-palm-beach-florida","decatur-georgia","chicago-illinois","baltimore-maryland","grosse-pointe-woods-michigan","kansas-city-missouri","las-vegas-nevada","newark-new-jersey","santa-fe-new-mexico","stony-brook-new-york","syracuse-new-york","greensboro-north-carolina","winston-salem-north-carolina","columbus-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","memphis-tennessee","austin-texas","dallas-texas","el-paso-texas","houston-texas","salt-lake-city-utah","lynchburg-virginia","seattle-washington","buenos-aires-argentina","ciudad-autonoma-buenos-aires-argentina","c-rdoba-argentina","rosario-argentina","san-miguel-de-tucum-n-argentina","darlinghurst-australia","sydney-australia","taringa-australia","perth-australia","curitiba-brazil","nova-igua-u-brazil","rio-de-janeiro-brazil","salvador-brazil","s-o-paulo-brazil","vancouver-canada","ottawa-canada","toronto-canada","montreal-canada","qu-bec-canada","regina-canada","aichi-japan","kanagawa-japan","osaka-japan","tokyo-japan","san-pedro-garza-garc-a-mexico","guadajalara-mexico","mexico-city-mexico","m-rida-mexico","san-juan-puerto-rico","pozuelo-de-alarc-n-spain","alicante-spain","badalona-spain","barcelona-spain","burgos-spain","cartagena-murcia-spain","c-rdoba-spain","elche-alicante-spain","madrid-spain","sabadell-barcelona-spain","seville-spain","valencia-spain","vigo-pontevedra-spain","birmingham-united-kingdom","liverpool-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 3: testing CAB ULA for HIV","inPlainEnglish":"This study compares the how well it works, whether it is safe and how hard side effects are to live with of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).","whoItsFor":["Ages 12 Years to any","Patient Study Participant (PSP) who can join","Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \\>35 kg","Documented HIV-1 RNA measurements \\<50 copies/mL in the 12 months prior to Screening","HIV-1 RNA \\<50 copies/mL at screening assessment","Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening","Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL)"],"whoShouldSkip":["Patient Study Participant (PSP)"],"whatHappens":"If you join, the listed intervention(s) are CAB ULA, RPV ULA, or CAB LA. The registry lists allocation as randomized. This study compares the how well it works, whether it is safe and how hard side effects are to live with of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 564 people at 84 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.525Z"},{"nctId":"NCT07651319","title":"Interleukine-2 (IL-2) Plus Semaglutide in Alzheimer's Disease","officialTitle":"A Phase Ib Clinical Trial, Using Interleukin-2 (IL-2) and Semaglutide in Patients With Alzheimer's Disease","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"The Methodist Hospital Research Institute","sponsorClass":"OTHER","summary":"Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited. Growing evidence suggests that inflammation in the brain and the body plays a key role in the onset and progression of AD. In particular, immune cells called regulatory T cells (Tregs), which normally help control inflammation, are impaired in AD individuals. This leads to increased activity of harmful immune pathways that worsen brain injury. Interleukin-2 (IL-2) is a drug that can restore the function of Tregs. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), such as semaglutide, are a class of drugs currently used to treat diabetes and obesity. Beyond their metabolic effects, GLP-1RAs also reduce inflammation, protect brain cells, and improve cellular energy balance. Laboratory studies, including our own, show that combining IL-2 with semaglutide has stronger effects than either drug alone. Together, they enhance Treg function, dampen harmful inflammatory responses, and improve cell survival. These findings support testing IL-2 plus semaglutide as a novel combination therapy for AD. We now propose a clinical trial to evaluate the safety, feasibility, and biological effects of this strategy. The study will enroll 30 individuals with AD, ages 50 to 86, who have a confirmed diagnosis by amyloid PET brain imaging and a Mini-Mental State Exam score between 16 and 26. Participants will be randomly assigned to one of three groups: (1) placebo, (2) low-dose IL-2 alone, or (3) IL-2 combined with semaglutide. Throughout the trial, participants will undergo regular medical exams, blood tests, and safety monitoring. We will measure how the treatment affects Tregs and other immune cells, inflammatory markers in blood and CSF, and established Alzheimer's biomarkers such as amyloid beta, tau, and neurofilament light chain. Cognitive and functional assessments will also be conducted to explore potential benefits on memory and daily living skills. If successful, this study will provide the first evidence that a dual immunotherapeutic strategy can safely modify disease-related processes in AD. Such findings would lay the foundation for larger clinical trials and could open the door to a new, multimodal approach to slowing or preventing Alzheimer's progression.","conditions":["Alzheimer Dementia (AD)"],"keywords":["Alzheimer's Disease","inflammation","Immunotherapy","IL-2","Semaglutide"],"interventions":[{"type":"DRUG","name":"IL-2 (Aldesleukin)"},{"type":"DRUG","name":"Semaglutide Plus IL-2"},{"type":"DRUG","name":"Placebo"}],"enrollment":30,"startDate":"2026-09-01","completionDate":"2029-06","sex":"ALL","minAge":"50 Years","maxAge":"86 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13.\n* Male or female age 50 to 86 years\n* MMSE between 16-26\n* Albumin greater than or equal to 3.0mg/dL\n* White Blood Count (WBC) \\>3,500/mm3; platelets \\>100,000/mm3; hematocrit (HCT) \\>32%.\n* INR\\<1.4\n* If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study.\n* English language speaking\n* Formal education of eight or more years\n* Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening\n* A family member or caretaker who is expected to be consistently available, administer study drugs of IL-2 and attend study visits throughout the study.\n* For AD patients with limited decision-making capacity, the legally authorized representative (LAR) should be present and consent based on the patient's best interest.\n\nExclusion Criteria:\n\n* Any untreated bacterial, fungal or viral infection\n* Renal dysfunction indicated by serum creatinine greater than 1.5 mg/dL\n* Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal\n* Clinically significant pulmonary dysfunction, including a history of chronic pulmonary disease (e.g., chronic obstructive pulmonary disease \\[COPD\\]) associated with functional limitation, or FEV₁ \\< 75% of predicted for age and height when pulmonary function testing indicated to evaluate ongoing respiratory symptoms\n* Clinically significant cardiac dysfunction, including a history of uncontrolled cardiac arrhythmias, prior cardiac tamponade, or unstable angina or myocardial infarction within 3 months prior to screening, or clinically significant abnormalities on baseline electrocardiogram (ECG). LVEF\\< 40% in echocardiography if clinically indicated based on ongoing cardiac symptoms or abnormal ECG findings\n* Hypersensitivity or allergy to IL-2\n* History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening.\n* History of hemorrhage or infarct or \\> 3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abscess or brain tumor with the exception of small incidental meningiomas) in prior CT or MRI.\n* Clinical or laboratory findings consistent with:\n\n  1. Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)\n  2. Other neurodegenerative condition (Parkinson's disease, amyotrophic lateral sclerosis, etc.)\n  3. Seizure disorder\n  4. History of infectious, metabolic or systemic diseases affecting the central nervous system (syphilis, vitamin B12 or folate deficiency, other laboratory values, etc.)\n  5. Clinically significant abnormal T4 or TSH\n* Clinically significant, advanced or unstable disease that may interfere with outcome evaluations, such as:\n\n  1. Respiratory insufficiency\n  2. Bradycardia (\\<45/min.) or tachycardia (\\>100/min.)\n  3. Poorly managed hypertension (systolic \\>160 mm Hg and/or diastolic \\>95 mm Hg) or hypotension (systolic \\<90 mm Hg and/or diastolic \\<60 mm Hg)\n  4. Uncontrolled diabetes defined by HbA1c \\>8%\n* History of cancer within 3 years of screening with the exception of fully excised non-melanoma skin cancers or non-metastatic prostate cancer that has been stable for at least 6 months.\n* History of acute/chronic hepatitis B or C and/or carriers of hepatitis B\n* History of organ allografts\n* Current treatment with insulin or insulin secretagogues (including sulfonylureas or meglitinides)\n* Prior GLP-1 RA administration or natural GLP1 supplements intake within the past 6 months\n* Disability that may prevent the patient from completing all study requirements (e.g., blindness, deafness, severe language difficulty, etc.).\n* Within 4 weeks of screening visit or during the course of the study, concurrent treatment with antipsychotic agents (except risperidone ≤1.5 mg/day, quetiapine ≤100 mg/day, olanzapine ≤5 mg/day, and aripiprazole ≤10 mg/day), antiepileptics (except lamotrigine, gabapentin and pregabalin for nonseizure indications), centrally active anti-hypertensive drugs (e.g., clonidine, l-methyl dopa, guanidine, guanfacine, etc.), opiate analgesics, systemic corticosteroids, psychostimulants, antiparkinsonian medications (except for non-parkinsonian indications) and mood stabilizers (e.g., valproate, lithium), sedatives, and anxiolytics with the exception that use of short- to medium-acting benzodiazepines for treatment of insomnia is permitted, however, use of sedatives or hypnotics should be avoided for 8 hours before administration of cognitive tests.\n* Nootropic drugs except stable AD meds (acetylcholinesterase inhibitors and memantine.\n* Use of concomitant CYP-metabolized medications with a narrow therapeutic index including warfarin, calcineurin inhibitors, or theophylline)\n* Suspected or known drug or alcohol abuse, i.e., more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) indicated by elevated MCV significantly above normal value at screening\n* Suspected or known allergy to any components of the study treatments.\n* Intake of investigational drug within the previous 30 days or five half-lives of the investigational drug, whichever is longer.\n* Contraindication to undergoing an LP including, but not limited to: inability to tolerate an appropriately flexed position for the time necessary to perform an LP; INR \\>1.4 or other coagulopathy; platelet count of \\<100,000/μL; infection at the desired lumbar puncture site; taking anti-coagulant medication within 90 days of screening (Note: low dose aspirin is permitted); suspected non-communicating hydrocephalus or intracranial mass; prior history of spinal mass or trauma.\n* Any condition, which in the opinion of the investigator makes the patient unsuitable for inclusion.","locations":[{"facility":"Houston Methodist Research Institute","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Alireza Alireza, MD","phone":"713-441-1150","email":"afaridar@houstonmethodist.org"}],"primaryOutcomes":["Evaluate the Incidence of Treatment-Emergent Adverse Events of IL-2 plus Semaglutide in AD patients"],"hasResults":false,"conditionSlugs":["alzheimer","als","obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing IL-2 (Aldesleukin) for Alzheimer Dementia (AD)","inPlainEnglish":"Alzheimer's disease (AD) is the most common cause of dementia. Despite major research efforts, effective treatments that slow or stop disease progression remain limited.","whoItsFor":["Ages 50 Years to 86 Years","Diagnosis of probable Alzheimer disease according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria13","Male or female age 50 to 86 years","Albumin greater than or equal to 3.0mg/dL","White Blood Count (WBC) \\>3,500/mm3; platelets \\>100,000/mm3; hematocrit (HCT) \\>32%","If on medications affecting cognition (rivastigmine, galantamine, donepezil, memantine), participants must be on stable dosage for at least 4 weeks prior to screening and should remain at a stable dosage during the course of the study","English language speaking","Formal education of eight or more years"],"whoShouldSkip":["Any untreated bacterial, fungal or viral infection","Renal dysfunction indicated by serum creatinine greater than 1.5 mg/dL","Hepatic impairment indicated by Alanine aminotransferase level (ALT) and aspartate aminotransferase (AST) greater than two times normal","Hypersensitivity or allergy to IL-2","History of severe gastrointestinal disease Hospitalization or change of chronic concomitant medication within one month prior to screening","Clinical or laboratory findings consistent with:","Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Creutzfeld-Jakob Disease(CJD), Down's syndrome, etc.)"],"whatHappens":"If you join, the listed intervention(s) are IL-2 (Aldesleukin), Semaglutide Plus IL-2, or Placebo. The registry lists allocation as randomized. Alzheimer's disease (AD) is the most common cause of dementia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.328Z"},{"nctId":"NCT07651852","title":"Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation","officialTitle":"Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Kardium Inc.","sponsorClass":"INDUSTRY","summary":"This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Globe Pulsed Field System"}],"enrollment":500,"startDate":"2026-10-09","completionDate":"2029-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Patients with a planned ablation procedure using the commercially available Globe PF System\n\nKey Exclusion Criteria:\n\n* Patients whose life expectancy is 1 year or less\n* Contraindication to left atrial catheter ablation or PF ablation\n* Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium","locations":[{"facility":"Arrhythmia Research Group","city":"Jonesboro","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Overlake Hospital","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Affairs","phone":"+1 (604) 248 8891","email":"Clinical.Affairs@kardium.com"}],"primaryOutcomes":["Effectiveness endpoint","Safety endpoint"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["jonesboro-arkansas","bellevue-washington"],"enrichment":{"headline":"Not a traditional drug phase: Globe Pulsed Field System for Atrial Fibrillation","inPlainEnglish":"This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).","whoItsFor":["Ages 18 Years to any","Patients with a planned ablation procedure using the commercially available Globe PF System"],"whoShouldSkip":["Patients whose life expectancy is 1 year or less","Contraindication to left atrial catheter ablation or PF ablation","Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.751Z"},{"nctId":"NCT07652242","title":"Phase 1 Study of a Self-amplifying RNA Vaccine (ITI-5000) in Stage 2-3 Triple Negative Breast Cancer","officialTitle":"A Phase 1, Multicenter, Open-label, First-in-Human Study of ITI-5000 (Self-Amplifying RNA Vaccine) Alone and in Combination With Standard of Care Adjuvant Therapy in Participants With Stage II-III Triple-Negative Breast Cancer (TNBC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Immunomic Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).\n\nITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly. The vaccine is delivered inside lipid nanoparticles (LNPs), similar to other approved mRNA vaccines.\n\nThe study has two parts:\n\n* Part A: Participants receive ITI-5000 alone at one of two dose levels (1 µg or 10 µg), given as an injection into the upper arm muscle every 28 days for 3 doses total. The goal is to find the safest dose.\n* Part B: Participants receive ITI-5000 at the best dose identified in Part A, combined with the following approved immunotherapy drugs pembrolizumab (Keytruda) and either olaparib or capecitabine.","conditions":["Triple Negative Breast Cancer (TNBC)"],"keywords":["TNBC","saRNA","Pembrolizumab","Phase I Clinical Trial","Immunotherapy","HERV-K","First in Human (FIH)","CT83"],"interventions":[{"type":"BIOLOGICAL","name":"ITI-5000 mRNA Vaccine"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"BIOLOGICAL","name":"ITI-5000 mRNA Vaccine"},{"type":"DRUG","name":"Olaparib"},{"type":"DRUG","name":"Capecitabine"},{"type":"BIOLOGICAL","name":"ITI-5000 MTD (Maximum Tolerated Dose)"}],"enrollment":60,"startDate":"2026-07-14","completionDate":"2028-02","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study.\n2. Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surgery. At the time of surgery, participant must not have achieved pCR.\n3. Applicable to Part B only. Participant is currently receiving or is planned to receive standard of care adjuvant therapy, including pembrolizumab in combination with capecitabine or olaparib in accordance with the FDA-approved label, with ≥3 cycles remaining if receiving 200mg Q3W or ≥2 cycles remaining if receiving 400 mg Q6W at the time of first ITI-5000 dose.\n4. Adults aged 18 years or over.\n5. Participants provided a signed and dated ICF.\n6. Participant agrees not to receive any routine vaccinations until at least 30 days after receiving the last study vaccine.\n7. TNBC diagnosed as pathologic stage 2-3 according to American Joint Committee on Cancer (AJCC) and confirmed by histological examination, e.g., negative for HER2 as defined by ASCO CAP 2023 guidelines. ER and PgR receptor negative by immunohistochemistry. Participants with BRCA mutations will be allowed.\n\n   a. Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation. Concurrent CDK4/6 inhibitors (ribociclib/abemaciclib) are not allowed.\n8. Applicable to Part A only. Participants with more than 4 weeks since last active therapy (chemotherapy, radiation therapy, or surgery) and 36 months or less following definitive surgery, based on the period of highest risk for recurrence in participants with stages 2-3 TNBC.\n9. Applicable to Part A only. Participants completed all planned previous cancer treatment (e.g., chemotherapy, radiation, therapy, surgery).\n10. Participant's ECOG performance status is 0 or 1.\n11. Participant had no significant ischemic heart disease or myocardial infarction within 3 months before vaccination #1 and has adequate cardiac function during eligibility evaluation, as evidenced by QTc of ≤470 msec for females or ≤450 msec for males assessed by the Fridericia method (QTcF) and evidenced by the average of measurements from triplicate ECGs at the screening visit.\n\n    a. The eligibility of participants with ventricular pacemakers for whom the QT interval may not be accurately measurable will be determined on a case-by-case basis by the sponsor in consultation with the medical monitor.\n12. Participant has an adequate organ function, as evidenced by the following tests conducted within 7 days before enrollment:\n\n    i. Hematology examination (excluding blood transfusion or use of hematopoietic stimulating agents for correction):\n\n1\\. Hemoglobin ≥8.0 g/L 2. Absolute neutrophil count (ANC) ≥1.0 × 109/L 3. Platelet count ≥100 × 109/L ii. Serum biochemistry examination (excluding recent blood transfusion or albumin administration):\n\n1\\. Alanine aminotransferase and AST ≤1.5 times the ULN 2. Alkaline phosphatase ≤2.5 ULN 3. Total bilirubin ≤ 1.5 ULN 4. Serum creatinine ≤1.5 ULN, with creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula) 13. Women of childbearing potential have a negative serum pregnancy test within 3 days before vaccination #1, and they and their partners agree to use highly effective methods of contraception during the study and for 6 months after the last administration of the study drug.\n\na. NOTE: A woman is considered of non-childbearing potential if she has had a documented bilateral oophorectomy, tubal ligation, or hysterectomy, or if she is postmenopausal, defined as ≥12 months of spontaneous amenorrhea without an alternative medical cause (with serum FSH confirmation if \\<55 years old). 14. Participant is able to attend the required study visits and follow-up as required by this protocol.\n\n15\\. Participant is able to understand and provide a signed informed consent that fulfills the relevant IRB or IEC guidelines prior to study registration.\n\n16\\. Participant agrees not to use alternative therapies from the time of informed consent through 30 days following vaccination #3. Participants may be asked to complete a \"wash out\" period before vaccination #1 at the principal investigator's discretion to ensure the absence of all alternative therapies.\n\nNOTE: \"Alternative therapies\" refer to non-prescription or non-standard medical interventions used with the intent to treat or prevent cancer or its symptoms, including but not limited to herbal remedies, high-dose dietary supplements marketed for therapeutic benefit, homeopathic preparations, or naturopathic treatments. Routine vitamins, minerals, or supportive care measures not expected to affect immune function may be continued at the investigator's discretion.\n\nExclusion Criteria:\n\n1. Applicable to Part B only. Participant discontinued prior treatment with an ICI due to irAEs.\n2. Participant underwent major surgery within 4 weeks before the planned day of vaccination #1 or received any other investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1.\n\n   i. Applicable to Part A only. Participant received cancer-directed therapy (chemotherapy, radiotherapy, biologic or immunotherapy, etc.) within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1. ii. Applicable to Part B only. Participants who received any PD-1 or PD-L1 inhibitor other than pembrolizumab will be excluded unless they have completed a washout period of ≥ 4 weeks or 5 half-lives of that agent (whichever is shorter) before Vaccination #1.\n3. Participant has toxicities due to prior immunotherapy. For the participant to be eligible, these toxicities must either have returned to ≤ Grade 1 or baseline or been deemed irreversible and in the opinion of the investigator not worsened by immunotherapy (e.g., ICI-endocrinopathies). Participants with any cardiac toxicities (regardless of the grade, etc.) will be excluded.\n4. Participant has toxicities due to prior chemotherapy that have not been resolved or considered stable and clinically manageable (e.g., neuropathies). Participants with any cardiac toxicities will be excluded.\n5. Participant has a significant medical illness, underlying health condition, or abnormal laboratory finding that, in the investigator's opinion, would increase the risk of participating in the study.\n6. Participants with an active autoimmune disease requiring immunosuppressive treatment within the last year (excluding irAEs), such as chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more).\n7. Female participants who are trying to conceive, are pregnant, or lactating.\n8. A positive serum pregnancy test at screening and/ or a positive human chorionic gonadotropin (hCG) urine test at baseline in women of childbearing potential.\n9. Participant concurrently participates in any other interventional clinical trial.\n10. Participant has known allergies to any of the components of the study vaccine.\n11. Participant has a history of anaphylaxis requiring medical intervention (including severe reactions to other mRNA vaccines, such as those against SARS-COV-2, etc.).\n12. Participant has a history of stroke, transient ischemic attack, unstable angina, or myocardial infarction within 3 months prior to the first dose of study treatment.\n13. Participant has a history of myocarditis or pericarditis.\n14. Participant has symptomatic congestive heart failure according to New York Heart Association (NYHA) classification, Class III or IV (per NYHA Classification), clinically significant cardiac arrhythmia, or a known left ventricular ejection fraction \\<45%.\n15. Participant has a history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome) or requires the use during study participation of concomitant medications known or suspected to prolong the QT/QTc interval, with the exception of drugs with low risk of QT/QTc prolongation that are used as standard premedication (e.g., diphenhydramine, famotidine, ondansetron).\n16. Participant received an mRNA or a live virus vaccine within 28 days of the planned vaccination #1. Flu and COVID vaccinations/boosters are also prohibited within 28 days before the planned day of vaccination #1. Vaccines that do not contain live virus are permitted.\n17. Participant has prior malignancy, except for the following:\n\n    i. adequately treated basal-cell or squamous-cell skin cancer, ii. in situ cervical cancer, iii. any other cancer from which the participant has been disease-free for at least 3 years.\n18. Participant has a history of organ transplant requiring immunosuppression. Participants with unstable human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) are not eligible.\n\n    a. Stable and well controlled HIV/AIDS participants on retroviral therapy, defined as those with no dose change within 4 weeks before the planned day of vaccination #1 and no anticipated dose change, are eligible.\n19. Participant with known active hepatitis B or C are not eligible. Active hepatitis B is defined as a known positive hepatitis B surface antigen (HBsAg) result. Active hepatitis C is defined by a known positive hepatitis C antibody result and known quantitative hepatitis C virus RNA results greater than the lower limits of detection of the assay.\n\n    a. Participants with a history of infection with hepatitis B virus or HCV may enroll if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.\n20. Participant was assessed by the investigator as being unable or unwilling to comply with the requirements of the treatment schedule and study procedures for any reason.\n21. Participant has a contraindication to IM injections or blood draws.","locations":[{"facility":"The Angeles Clinic and Research Institute (TACRI)","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START Midwest","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"START San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Scott L Wehage, M.S.","phone":"301-968-3501","email":"studyinquiries@immunomix.com"}],"primaryOutcomes":["Incidence of Dose-Limiting Toxicities as Assessed by CTCAE v5.0"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["los-angeles-california","grand-rapids-michigan","nashville-tennessee","san-antonio-texas"],"enrichment":{"headline":"Phase 1: testing ITI-5000 mRNA Vaccine for Triple Negative Breast Cancer (TNBC)","inPlainEnglish":"This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC). ITI-5000 is a self-amplifying RNA (saRNA) vaccine that instructs the immune system to recognize and attack cancer cells expressing two proteins found on TNBC cells-HERV-K and CT83-fused with a molecule called LAMP-1 that helps the immune system respond more strongly.","whoItsFor":["Ages 18 Years to any","Women only","Applicable to Part A only. Participants must have completed adjuvant pembrolizumab if they were receiving it before enrolling in the study","Applicable to Cohort 3A and Part B only. Participant must have received neoadjuvant chemotherapy with pembrolizumab, then undergone definitive surgery. At the time of surgery, participant must not have achieved pCR","Adults aged 18 years or over","Participants provided a signed and dated ICF","Participant agrees not to receive any routine vaccinations until at least 30 days after receiving the last study vaccine","a. Concurrent endocrine therapy (e.g., tamoxifen, aromatase inhibitors, ovarian suppression) is not permitted during study participation. Concurrent CDK4/6 inhibitors (ribociclib/abemaciclib) are not allowed","Applicable to Part A only. Participants with more than 4 weeks since last active therapy (chemotherapy, radiation therapy, or surgery) and 36 months or less following definitive surgery, based on the period of highest risk for recurrence in participants with stages 2-3 TNBC"],"whoShouldSkip":["Applicable to Part B only. Participant discontinued prior treatment with an ICI due to irAEs","Participant underwent major surgery within 4 weeks before the planned day of vaccination #1 or received any other investigational drug or device within 4 weeks or 5 half-lives of that agent (whichever is shorter) before the planned day of Vaccination #1","Participant has toxicities due to prior chemotherapy that have not been resolved or considered stable and clinically manageable (e.g., neuropathies). Participants with any cardiac toxicities will be excluded","Participant has a significant medical illness, underlying health condition, or abnormal laboratory finding that, in the investigator's opinion, would increase the risk of participating in the study","Participants with an active autoimmune disease requiring immunosuppressive treatment within the last year (excluding irAEs), such as chronic prolonged systemic corticosteroid use (defined as corticosteroid use lasting one month or more)","Female participants who are trying to conceive, are pregnant, or lactating","A positive serum pregnancy test at screening and/ or a positive human chorionic gonadotropin (hCG) urine test at baseline in women of childbearing potential"],"whatHappens":"If you join, the listed intervention(s) are ITI-5000 mRNA Vaccine, Pembrolizumab, or ITI-5000 mRNA Vaccine. The registry lists allocation as randomized. This study tests an investigational cancer vaccine called ITI-5000 in people who have completed standard treatment for early-stage triple-negative breast cancer (TNBC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.658Z"},{"nctId":"NCT07654751","title":"A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","officialTitle":"A Phase 4, Open-Label, Milk-Only Lactation Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.\n\nThis is a fully remote (virtual) study. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.","conditions":["Psoriasis","Colitis, Ulcerative","Crohn Disease","Arthritis, Psoriatic"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Breast Milk Sample Collection"},{"type":"DRUG","name":"Guselkumab"}],"enrollment":10,"startDate":"2026-08-07","completionDate":"2027-08-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records\n* Be medically stable on the basis of medical history review performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator\n* Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1\n* Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study\n* Must be at least 5 weeks postpartum on Day 1\n* Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study\n* Must plan to continue breastfeeding throughout the duration of the study\n\nExclusion criteria\n\n* Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments\n* Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening\n* Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study\n* Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed\n* Has a positive urine pregnancy test on Day 1","locations":[{"facility":"University of North Carolina at Chapel Hill","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Guselkumab Concentrations at Steady State in Breast Milk (Q4W Maintenance Regimen)","Guselkumab Concentrations at Steady State in Breast Milk (Q8W Maintenance Regimen)","Estimated Daily Infant Dosage of Guselkumab Q4W Maintenance Regimen","Estimated Daily Infant Dosage of Guselkumab Q8W Maintenance Regimen"],"hasResults":false,"conditionSlugs":["psoriasis","crohns-disease"],"drugSlugs":[],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Phase 4: testing Guselkumab for Psoriasis","inPlainEnglish":"The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications. Participants can complete all study-related activities, including consent, study visits, and breast milk sample collection, from home without attending an in-person study site.","whoItsFor":["Ages 18 Years to any","Women only","Has an active diagnosis of at least one approved indication for guselkumab (psoriasis, psoriatic arthritis \\[PsA\\], UC and CD) as confirmed by medical records","Currently is on established guselkumab maintenance therapy, that is, has received at least 2 guselkumab subcutaneous (SC) maintenance doses before Day 1","Has made the decision to be treated with guselkumab and to breastfeed independently prior to the participant consenting to participate in this study","Must be at least 5 weeks postpartum on Day 1","Have well-established lactation; participant must be exclusively breastfeeding their infant(s) (or not providing more than 1 supplemental bottle of formula/day) when enrolled in the study","Must plan to continue breastfeeding throughout the duration of the study"],"whoShouldSkip":["Has any current or previous illness that, in the opinion of the investigator, might confound the results of the study or that could prevent, limit, or confound the protocol specified assessments","Has history of drug or alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) criteria within 1 year before screening","Uses or has used an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month before enrolling in the study","Has received or plans to receive any live, attenuated vaccine within 12 weeks prior to administration of guselkumab. Non-live vaccines approved or authorized for emergency use (for example, Coronavirus disease-19 \\[COVID-19\\]) by local health authorities are allowed","Has a positive urine pregnancy test on Day 1"],"whatHappens":"If you join, the listed intervention(s) are Breast Milk Sample Collection, or Guselkumab. The registry lists allocation as randomized. The purpose of this post-marketing study is to assess the amount of guselkumab in breast milk of lactating women receiving guselkumab as part of their standard clinical care provided by their treating physician, for any of the approved indications.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 10 people at Chapel Hill. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.576Z"},{"nctId":"NCT07655375","title":"Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut","officialTitle":"Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Guy Boeckxstaens","sponsorClass":"OTHER","summary":"Study evaluating the effect of UCB8600 on mast cell activation in the human gut:\n\nIBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.\n\nRecently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called \"UCB8600\" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.","conditions":["IBS (Irritable Bowel Syndrome)"],"keywords":["IBS","irritable bowel syndrome","UCB8600","mast cells"],"interventions":[{"type":"OTHER","name":"Sample collection"}],"enrollment":60,"startDate":"2026-08-18","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):\n\n1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures\n2. At least 18 years of age at the time of signing the Informed Consent Form (ICF)\n3. Undergoing surgery for colorectal cancer\n4. No preoperative radiotherapy or chemotherapy\n\nExclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):\n\n1. Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery\n2. Inflammatory bowel disease (IBD) or diverticulitis\n3. Diabetes or BMI ≥ 30 kg/m²\n4. Subject is legally incapacitated\n\nInclusion Criteria group 2 (rectal biopsies from IBS patients):\n\n1. Voluntary written informed consent of the subject has been obtained prior to any screening procedures\n2. At least 18 years of age and maximum age of 65 years of age at the time of signing the Informed Consent Form (ICF)\n3. Diagnosed with IBS\n\nExclusion Criteria group 2 (rectal biopsies from IBS patients):\n\n1. Subject has internal/external hemorrhoids at the moment of biopsy sampling.\n2. Using bloodthinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).\n3. Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. These should be stopped 2 weeks prior to the biopsy sampling.\n4. Subject is legally incapacitated","locations":[{"facility":"University Hospitals Leuven","city":"Leuven","state":"Vlaams-Brabant","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ine De Booser, MSc","phone":"0032-16-341943","email":"ine.debooser@uzleuven.be"}],"primaryOutcomes":["Total percentage of degranulated mast cells, detected using fluorescence microscopy","Total corrected cellular fluorescence (TCCF) per mast cell"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["leuven-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Sample collection for IBS (Irritable Bowel Syndrome)","inPlainEnglish":"Study evaluating the effect of UCB8600 on mast cell activation in the human gut: IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.","whoItsFor":["Ages 18 Years to 65 Years","group 1 (resection tissue from surgery patients = healthy volunteers):","Undergoing surgery for colorectal cancer","No preoperative radiotherapy or chemotherapy"],"whoShouldSkip":["group 1 (resection tissue from surgery patients = healthy volunteers):","Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery","Inflammatory bowel disease (IBD) or diverticulitis","Diabetes or body-mass index (BMI) ≥ 30 kg/m²","Subject is legally incapacitated","who can join group 2 (rectal biopsies from IBS patients):"],"whatHappens":"If you join, the listed intervention(s) are Sample collection. The registry lists allocation as randomized. Study evaluating the effect of UCB8600 on mast cell activation in the human gut: IBS is a disease characterized by abdominal pain and a change in stool.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Leuven. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.439Z"},{"nctId":"NCT07655583","title":"OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy","officialTitle":"OBSERVE: A Pilot Study Of Omission Of Brain Metastasis Stereotactic Radiosurgery Following Resection With CNS-Active Systemic Therapy","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.","conditions":["Brain Metastasis","Stereotactic Radiosurgery","Resection","Systemic Therapy"],"keywords":[],"interventions":[{"type":"OTHER","name":"Systemic therapy"}],"enrollment":20,"startDate":"2026-05-27","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Eligibility Criteria\n\n1. Age ≥ 18 years.\n2. ECOG performance status ≤ 2.\n3. Participants with a resected brain metastasis with gross total resection and pathologic confirmation of NSCLC or melanoma. Gross total resection must be confirmed based on a review of the operative report, pathology, and all post-operative images available at the time of enrollment.\n4. Brain metastasis resection occurred ≤ 5 weeks ago.\n5. Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is confirmed pathologically at the most recent resection.\n6. The resected lesion has never previously been targeted by radiotherapy.\n7. Evaluation by a brain metastasis multidisciplinary team (BM-MDT), consisting of a medical oncologist (can be the patient's primary medical oncologist), a radiation oncologist who regularly performs SRS, and a neurosurgeon, and agreement that the intracranial cavity does not or will not require immediate post-operative radiation (i.e. it is judged to be safe to omit post-operative radiation). This BM-MDT evaluation can take place in clinic or during a multidisciplinary conference, either before or after the surgical resection. If the BM-MDT evaluation was before the surgical resection, there can be no new findings in the interim (e.g. during or after the surgical resection) that would change the BM-MDT's recommendation, as determined by one or more of the patient's treating physicians.\n8. Documentation by the patient's primary medical oncologist of a planned study systemic therapy regimen consisting of one of the following: dual-agent immune checkpoint inhibitors (e.g. ipilimumab and nivolumab) for melanoma, osimertinib for EGFR Mutant (e.g. Exon 19 deletion; L858R) NSCLC, and brigatinib, alectinib, or lorlatinib for ALK rearranged/fusion positive NSCLC. As new agents are approved, other highly-CNS active tyrosine kinase inhibitors for participants with NSCLC may be included at the discretion of the principal investigator.\n9. For a participant with more than one recently resected brain metastasis that meets eligibility criteria #3-#7 above, it is permissible (but not mandated) for more than one surgical cavity to proceed without immediate post-operative radiation. All other intracranial disease must proceed with treatment according to standard-of-care practices at the time of enrollment. This may include treatment with SRS or observation if clinically appropriate.\n10. Regarding prior systemic therapy:\n\n    1. For participants with melanoma: no prior disease progression on any immune checkpoint inhibitor agent and ≥ 6 months between the last dose of any immune checkpoint inhibitor agent and initiation of the study systemic therapy regimen.\n    2. For participants with EGFR Mutant NSCLC: no prior disease progression on any EGFR-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any EGFR-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen.\n    3. For participants with ALK rearranged/fusion positive NSCLC: no prior disease progression on any ALK-targeted tyrosine kinase inhibitor and ≥ 6 month between the last dose of any ALK-targeted tyrosine kinase inhibitor and initiation of the study systemic therapy regimen.\n11. This study will allow non-English speaking subjects to be enrolled. Verbal Translation Preparative Sheet (VTPS) will be used if a translated consent form is not available in the subject's language. The consent form will be translated into the language of the subject after 2 or more occurrences. This will apply to any MD Anderson patient.\n\nExclusion Criteria\n\n1. History of known leptomeningeal involvement (radiographic or cytological).\n2. Subjects that have previously received or are currently planned for whole brain radiotherapy.\n3. Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy.\n4. Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled.\n5. Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast.\n6. Pregnancy or plans to become pregnant during the duration of the study.","locations":[{"facility":"MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas H Beckham, MD","phone":"(281) 217-2904","email":"thbeckham@mdanderson.org"}],"primaryOutcomes":["safety and adverse events (AEs)."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 1: Systemic therapy for Brain Metastasis","inPlainEnglish":"To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.","whoItsFor":["Ages 18 Years to any","Eligibility Criteria","how well you can do daily activities (ECOG score) ≤ 2","Brain metastasis resection occurred ≤ 5 weeks ago","Additional prior surgeries, including Laser Interstitial Thermal Therapy (LITT), to the same or nearby location are permitted, provided that residual disease or local recurrence is confirmed pathologically at the most recent resection","The resected lesion has never previously been targeted by radiotherapy","Regarding prior systemic therapy:","For participants with melanoma: no prior disease progression on any immune checkpoint inhibitor agent and ≥ 6 months between the last dose of any immune checkpoint inhibitor agent and initiation of the study systemic therapy regimen"],"whoShouldSkip":["History of known leptomeningeal involvement (radiographic or cytological)","Subjects that have previously received or are currently planned for whole brain radiotherapy","Prior unacceptable toxicity on one or more of the agents comprising the planned study systemic therapy","Cognitively impaired subjects with a major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled","Participant unable to receive a brain MRI (implanted metal devices or foreign bodies) or MRI contrast","Pregnancy or plans to become pregnant during the duration of the study"],"whatHappens":"If you join, the listed intervention(s) are Systemic therapy. The registry lists allocation as na. To remove a brain tumor, patients usually receive radiation to lower the chance that the cancer will come back in the spot where the tumor was removed.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Houston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.687Z"},{"nctId":"NCT07656415","title":"A Study to Investigate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease (SCD)","officialTitle":"A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Agios Pharmaceuticals, Inc.","sponsorClass":"INDUSTRY","summary":"The primary objective of this study is to determine the effect of mitapivat versus placebo on the need for transfusions in subjects with SCD.","conditions":["Sickle Cell Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Mitapivat Matched Placebo"},{"type":"DRUG","name":"Mitapivat"}],"enrollment":159,"startDate":"2026-07-21","completionDate":"2029-08","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥12 years.\n* Documented diagnosis of SCD (hemoglobin SS (HbSS), combined heterozygosity for hemoglobins S and C (HbSC), sickle cell hemoglobin (HbS)/β0-thalassemia, HbS/β+-thalassemia, or other sickle cell syndrome variants).\n* No more than 10 SCPCs in the 12 months before providing informed assent/consent.\n* At least 1 transfusion of packed RBCs in the 12 months before informed assent/consent.\n* Hb ≥5.5 and ≤10.5 g/dL. Hb concentration must be based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the Screening Period.\n* Additional signs or symptoms of hemolysis, as evidenced by any laboratory assessment during the Screening Period with\n\n  * Hb \\<8 g/dL, or\n  * Absolute reticulocyte count \\> upper limit of normal (ULN), or\n  * Indirect bilirubin \\>ULN, or\n  * LDH \\>ULN\n* If taking hydroxyurea, the hydroxyurea dose must be stable for at least 90 days prior to randomization. Discontinuation of hydroxyurea requires a 90-day washout prior to informed assent/consent.\n* Women of childbearing potential (WOCBP) and pediatric female subjects who have attained menarche must be abstinent of sexual activities that may induce pregnancy as part of their usual lifestyle or agree to use a highly effective method of contraception from the time of providing informed assent/consent, throughout the study, and for 28 days after the last dose of study drug; if the highly effective method of contraception is hormonal contraception, then an acceptable barrier method must also be used.\n* Written informed assent/consent (for subjects under 18 years of age, or prior to the age at which a subject is considered legally an adult per local regulations, parental permission and child assent will be obtained) must be obtained before any study-related procedures are conducted and subjects must be willing to comply with all study procedures for the duration of the study.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or parturient.\n* Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventative transfusion); episodic transfusion in response to worsened anemia or vaso-occlusive crisis (VOC) is permitted. Additionally, a subject who requires episodic transfusion(s) may not have received a transfusion(s) within 60 days before providing informed assent/consent or during the Screening Period.\n* Hospitalized for an SCPC and/or other vaso-occlusive event within 14 days prior to providing informed assent/consent or during the Screening Period. A hospitalization is defined as an in-patient admission to a hospital that may or may not be preceded by an emergency room or outpatient clinic visit. A visit to an emergency room that does not result in an in-patient admission does not meet the definition of hospitalization.\n* Currently receiving treatment with a disease-modifying therapy for SCD (eg, voxelotor, crizanlizumab, L-glutamine), with the exception of hydroxyurea. The last dose of voxelotor, crizanlizumab, and L-glutamine must have been administered at least 90 days before randomization.\n* History of any malignancy except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ. Subjects must not have active disease or received anticancer treatment ≤5 years before providing informed assent/consent.\n* History of active and uncontrolled cardiac or pulmonary disease within 6 months before randomization, including but not limited to:\n\n  * New York Heart Association Class III or IV heart failure or clinically significant dysrhythmia.\n  * Myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism.\n  * Heart rate-corrected QT interval using Fridericia's method of ≥470 milliseconds for female subjects and ≥450 milliseconds for male subjects, except for right or left bundle branch block.\n  * Severe pulmonary fibrosis as defined by severe hypoxia, evidence of right-sided heart failure, and radiographic pulmonary fibrosis \\>50%.\n  * Severe pulmonary hypertension as defined by severe symptoms associated with hypoxia, right heart failure, and oxygen indicated.\n* Hepatobiliary disorders including but not limited to:\n\n  * Liver disease with histopathological evidence or clinical diagnosis of cirrhosis or severe fibrosis.\n  * Clinically symptomatic cholelithiasis or cholecystitis (subjects with prior cholecystectomy are eligible).\n  * History of drug-induced cholestatic hepatitis.\n  * Aspartate aminotransferase (AST) \\>2.5× ULN (unless due to hemolysis and/or hepatic iron deposition) and alanine aminotransferase (ALT) \\>2.5× ULN (unless due to hepatic iron deposition).\n* Renal dysfunction as defined by an estimated glomerular filtration rate \\<30 milliliters per minute (mL/min)/1.73-meter square (m\\^2) by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation.\n* Active uncontrolled infection requiring systemic antimicrobial therapy.\n* Positive test for hepatitis C virus (HCV) antibody (Ab) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg).\n* Positive test for human immunodeficiency virus (HIV)-1 antibody or HIV-2 antibody.\n* History of major surgery (including splenectomy) ≤16 weeks before providing informed assent/consent and/or planning on undergoing a major surgical procedure during the study.\n* Current enrollment or past participation (within 90 days before randomization or a time frame equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational study drug or device.\n* Past enrollment in a clinical study involving mitapivat.\n* Prior exposure to gene therapy or prior bone marrow or stem cell transplantation.\n* Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered at least 90 days before randomization.\n* Receiving products that are strong inhibitors of Cytochrome3A4/5 (CYP3A4/5) that have not been stopped for ≥5 days or a time frame equivalent to 5 half-lives (whichever is longer), or strong inducers of Cytochrome3A4 (CYP3A4) that have not been stopped for ≥28 days or a time frame equivalent to 5 half-lives (whichever is longer), prior to randomization.\n* Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed; the testosterone dose and preparation must be stable for ≥10 weeks before randomization.\n* Known allergy to mitapivat or tablet excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, magnesium stearate, and the Opadry Blue II film-coat \\[hypromellose, titanium dioxide, lactose monohydrate, triacetin, and FD\\&C Blue #2\\]).\n* Any medical, hematological, psychological, or behavioral condition(s), including alcohol use disorder, or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:\n\n  * Subjects unable to receive RBC transfusions (eg, due to presence of allo-antibodies, lack of blood availability).\n  * Subjects deprived of liberty by court or administrative decision (eg, persons accommodated in an institution by order of an authority or court).\n  * Subjects undergoing psychiatric care without their consent.\n  * Subjects admitted to a health or social establishment for purposes other than research.\n  * Adult Subjects subject to a legal protection measure (guardian, curatorship, legal protection).\n  * Subjects unable to express their consent.\n* Receiving herbal or dietary supplements that have not been stable in dose and preparation for ≥8 weeks prior to randomization.","locations":[{"facility":"Indiana Hemophilia & Thrombosis Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer and Hematology Centers (CHC)","city":"Grand Rapids","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Specialty Clinic","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Agios Medical Affairs","phone":"08332288474","email":"medinfo@agios.com"}],"primaryOutcomes":["Percentage of Subjects who are Transfusion Free From Week 4 Through Week 52"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["indianapolis-indiana","grand-rapids-michigan","flowood-mississippi","new-york-new-york","houston-texas"],"enrichment":{"headline":"Phase 3: testing Mitapivat Matched Placebo for Sickle Cell Disease","inPlainEnglish":"The primary objective of this study is to determine the effect of mitapivat versus dummy treatment (placebo) on the need for transfusions in subjects with SCD.","whoItsFor":["Ages 12 Years to any","Documented diagnosis of SCD (hemoglobin SS (HbSS), combined heterozygosity for hemoglobins S and C (HbSC), sickle cell hemoglobin (HbS)/β0-thalassemia, HbS/β+-thalassemia, or other sickle cell syndrome variants)","No more than 10 SCPCs in the 12 months before providing informed assent/consent","At least 1 transfusion of packed RBCs in the 12 months before informed assent/consent","Hb ≥5.5 and ≤10.5 g/dL. Hb concentration must be based on an average of at least 2 Hb concentration measurements (separated by ≥7 days) collected during the Screening Period","Additional signs or symptoms of hemolysis, as evidenced by any laboratory assessment during the Screening Period with","Absolute reticulocyte count \\> upper limit of normal (ULN), or","Indirect bilirubin \\>ULN, or"],"whoShouldSkip":["Pregnant, breastfeeding, or parturient","Currently receiving treatment with a disease-modifying therapy for SCD (eg, voxelotor, crizanlizumab, L-glutamine), with the exception of hydroxyurea. The last dose of voxelotor, crizanlizumab, and L-glutamine must have been administered at least 90 days before randomization","History of any malignancy except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ. Subjects must not have active disease or received anticancer treatment ≤5 years before providing informed assent/consent","History of active and uncontrolled cardiac or pulmonary disease within 6 months before randomization, including but not limited to:","New York Heart Association Class III or IV heart failure or clinically significant dysrhythmia","Myocardial infarction or unstable angina pectoris; hemorrhagic, embolic, or thrombotic stroke; deep venous thrombosis; or pulmonary or arterial embolism","Heart rate-corrected QT interval using Fridericia's method of ≥470 milliseconds for female subjects and ≥450 milliseconds for male subjects, except for right or left bundle branch block"],"whatHappens":"If you join, the listed intervention(s) are Mitapivat Matched Placebo, or Mitapivat. The registry lists allocation as randomized. The primary objective of this study is to determine the effect of mitapivat versus dummy treatment (placebo) on the need for transfusions in subjects with SCD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 159 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.835Z"},{"nctId":"NCT07660731","title":"A Study to Learn How Different Amounts of the Study Medicine Called PF-08103402 Are Tolerated and Act in the Body in Healthy Adults or Adults With Mild To-moderate Asthma","officialTitle":"A PHASE 1 STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, FOOD EFFECT, METABOLISM & EXCRETION, AND DRUG-DRUG INTERACTION POTENTIAL OF PF-08103402 IN HEALTHY ADULTS AND/OR ADULTS WITH MILD TO MODERATE ASTHMA","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.\n\nFor Parts A, B, C, D and F, the study is seeking participants who:\n\n* Are healthy (do not have disease) males or females who can no longer have children,\n* Are 18 to 65 years old,\n* Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a body weight of more than 50 kilograms (110 pounds). Body mass index is a way to measure body fat by using a person's height and weight\n\nFor Part A (optional group or cohort 3: Japanese participants only):\n\n* A body weight of more than 45 kilograms (100 pounds).\n* Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n* Adults with a documented history of asthma (confirmed by a doctor) for at least 12 months before entering the study.\n* Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nThe study has six parts: Part A, Part B, Part C, Part D, Part E and Part F. The study medicine will be taken as a suspension or tablet by mouth 1 time a day (except in Parts B and E where it will be taken 1 time a day for 14 days) at the study clinic. The study will help understand:\n\n* how the body processes the study medicine in healthy participants (Parts A and B),\n* how much of the study medicine gets into the bloodstream and if food affects the amount of study medicine in the blood in healthy participants (Part C),\n* how the study medicine is broken down and leaves the body in healthy participants (Optional Part D),\n* how the study medicine is processed in adults with mild-to-moderate asthma (Optional Part E),\n* if taking the study medicine together with another medicine affects how each medicine is processed by the body in healthy participants (Optional Part F).\n\nParticipants will take part in the study for about 10 weeks (Parts A and F), 12 weeks (Part B), 9 weeks (Parts C and D), and 16 weeks (Part E).\n\nDuring this time, they will have 2 study visits at the study clinic and up to 28 overnight stays (Part A), 18 overnight stays (Parts B and E), 10 overnight stays (Part C), 11 overnight stays (Part D), and 16 overnight stays (Part F). The study team will also call participants 1 time over the phone at the end of the study to assess how they are doing.\n\nStudy measurements will be taken by body examination, monitoring side effects, blood and urine tests, heart tests (ECG), vital signs (blood pressure, pulse and respiratory rate), questionnaires (Parts C and E), stool samples (Part D only), and breathing tests (Part E only).","conditions":["Healthy Volunteer Study","Healthy Adults","Healthy Participants","Asthma"],"keywords":["Human","Randomized","Metabolism","Excretion","Drug-Drug Interaction","Food effect"],"interventions":[{"type":"DRUG","name":"PF-08103402"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Midazolam"}],"enrollment":133,"startDate":"2026-06-17","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Key Inclusion criteria (Parts A, B, C, D and F):\n\n1. Are males or females who can no longer have children,\n2. Are 18 to 65 years old,\n3. Have a body mass index (BMI) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nFor Part A (Optional group or cohort 3: Japanese participants only):\n\n1. A total body weight of more than 45 kg (100 pounds).\n2. Have 4 biological Japanese grandparents who were born in Japan.\n\nFor Part E only:\n\n1. Adults with a documented doctor's-diagnosis history of asthma for at least 12 months before entering the study.\n2. Have a body mass index (BMI) of 16 to 35 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds).\n\nKey Exclusion criteria\n\n1. Evidence or history of clinically significant medical conditions.\n2. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb).\n3. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.\n4. Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study.\n5. Any history of parasitic infection requiring treatment within 28 days prior to screening.\n6. Positive tuberculosis infection test result.\n7. Part C only: Evidence or history of conditions interfering with the ability to taste.\n8. Part D only: History of irregular bowel movements.\n9. Part E only: Evidence of lung disease(s) other than asthma.\n10. Part E only: Asthma exacerbation within 3 months prior to screening.\n11. Part F only: History of acute narrow-angle glaucoma, untreated open-angle glaucoma, sleep apnea, respiratory insufficiency, myasthenia gravis or adverse reaction to midazolam or other benzodiazepines.","locations":[{"facility":"Pfizer Clinical Research Unit - New Haven","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pfizer Clinical Research Unit - Brussels","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Number of Participants with Treatment Emergent Adverse Events (TEAEs)","Number of Participants with Serious Adverse Events (SAEs)","Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities","Number of Participants With Clinically Significant Change From Baseline in Vital Signs","Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings","Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise (AUClast) in the fasted state","Maximum observed plasma concentration (Cmax) in the fasted state","Total recovery of drug-related material in urine and feces separately, and both routes combined, expressed as a percent of total dose administered","Maximum observed plasma concentration (Cmax)","Area under the curve from time zero to extrapolated infinite time (AUCinf) if data permit, otherwise AUClast"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","brussels-belgium"],"enrichment":{"headline":"Phase 1: testing PF-08103402 for Healthy Volunteer Study","inPlainEnglish":"This study wants to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma. This is the first time the study medicine is being given to people.","whoItsFor":["Ages 18 Years to 65 Years","Key (Parts A, B, C, D and F):","Are males or females who can no longer have children,","Are 18 to 65 years old,","Have a body mass index (body-mass index (BMI)) of 16 to 32 kilograms per meter squared and a total body weight of more than 50 kilograms (110 pounds)","For Part A (Optional group or cohort 3: Japanese participants only):","A total body weight of more than 45 kg (100 pounds)","Have 4 biological Japanese grandparents who were born in Japan"],"whoShouldSkip":["Evidence or history of clinically significant medical conditions","History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCVAb)","History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening","Participation in studies of other investigational products (drug or vaccine) at any time during their participation in this study","Any history of parasitic infection requiring treatment within 28 days prior to screening","Positive tuberculosis infection test result","Part C only: Evidence or history of conditions interfering with the ability to taste"],"whatHappens":"If you join, the listed intervention(s) are PF-08103402, Placebo, or Midazolam. The registry lists allocation as randomized. This study wants to learn about the safety of a new study medicine called PF-08103402 in healthy adults (do not have disease) and or in adults with mild-to-moderate asthma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 133 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.350Z"},{"nctId":"NCT07661095","title":"A Study of CRD3874-SI in People With Leukemia","officialTitle":"A Phase 1 Study of the STING Agonist CRD3874-SI for Relapsed and Refractory Acute Myeloid Leukemia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).","conditions":["Acute Myeloid Leukemia","AML","Refractory Acute Myeloid Leukemia"],"keywords":["Acute Myeloid Leukemia","AML","Refractory Acute Myeloid Leukemia","CRD3874-SI","Memorial Sloan Kettering Cancer Center","26-144"],"interventions":[{"type":"DRUG","name":"CRD3874-SI"}],"enrollment":24,"startDate":"2026-06-15","completionDate":"2028-06-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Participant has relapsed or refractory acute myeloid leukemia, defined as bone marrow blasts ≥ 5%, and/or reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, and/or development of extramedullary disease; or, no CR, CRh or CRi at response assessment after at least 1 line of therapy, as defined by standardized European LeukemiaNet 2022 Criteria. Patients must have failed treatment with available therapies known to be active for treatment of their AML.\n* Participant must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)\n* For patients with known HIV, HBV, and/or HCV infection \\[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\\]:\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Required Organ Function\n\n  * Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  * Serum total bilirubin \\< 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL/min by Cockcroft-Gault formula or CKD-EPI 2021 or estimated glomerular filtration rate 60 mL/min or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  * Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Blast phase of chronic myeloid leukemia\n* Known active central nervous system leukemia\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG; National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] v6.0 Grade ≥ 3)\n* Prior organ transplantation, other than allogeneic or autologous hematopoietic stem cell transplantation.\n* Received a live vaccine within 30 days of the planned start of study drug.\n\n  a. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.)\n* Evidence of clinically significant immunosuppression including the following:\n\n  a. Primary immunodeficiency state such as SCID b. Concurrent opportunistic infection c. Receiving systemic immunosuppressive therapy (\\>2 weeks) including oral steroid doses \\> 10 mg/day of prednisone or equivalent within seven days prior to enrollment. In the setting of non-immune mediated indications for use, chronic/active low dose steroid use (equivalent to ≤ 10 mg/day prednisone) may be permitted at the discretion of the Principal Investigator i. (Note: Other steroid formulations or steroid use for other indications may be permitted and include: 1) Intranasal, inhaled, ocular, or topical steroids, or local steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent; 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past two years prior to enrollment\n\n  a. (Note: Replacement therapy \\[e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency\\] is not considered a form of systemic treatment for autoimmune disease.)\n* Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and/or stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 470 ms. Patients with a QTcF over 470 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment).\n* Participant with active use of strong or moderate CYP3A4 inhibitors.\n* Female participant who is pregnant or lactating.\n* Because STING agonist agents impact immune and cellular functioning posing potential risk for impacting normal embryonic development, and because other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy. Male or female participants not willing to comply with contraceptive requirements will be excluded, which adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy","locations":[{"facility":"Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (All protocol activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (All Protocol Activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (All protocol activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (All Protocol Activities)","city":"Rockville Centre","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Leora Boussi, MD","phone":"646-608-4442","email":"boussil@mskcc.org"},{"name":"Eytan Stein, MD","phone":"646-608-3749","email":""}],"primaryOutcomes":["Maximum tolerated dose of CRD3874-SI"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","rockville-centre-new-york"],"enrichment":{"headline":"Phase 1: testing CRD3874-SI for Acute Myeloid Leukemia","inPlainEnglish":"This study wants to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).","whoItsFor":["Ages 18 Years to any","Documentation of Disease","Participant must weigh at least 40 kg","Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)","For patients with known HIV, HBV, and/or HCV infection \\[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and/or HCV infection\\]:","HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial","For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated","Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load"],"whoShouldSkip":["Participants with acute promyelocytic leukemia","Participants with isolated myeloid sarcoma","Blast phase of chronic myeloid leukemia","Known active central nervous system leukemia","Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome","Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study","Participants with concurrent other malignancy that will confound interpretation of study endpoints"],"whatHappens":"If you join, the listed intervention(s) are CRD3874-SI. The registry lists allocation as randomized. This study wants to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.823Z"},{"nctId":"NCT07661862","title":"PERCEIVE-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID","officialTitle":"Persistent Cardiovascular Effects of COVID-19 Viral Infection Trial (PERCEIVE)-Outreach: A Scalable, Risk-Based Model for Managing Persistent Cardiovascular Impact in Long COVID","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Tasmania","sponsorClass":"OTHER","summary":"Some people who had COVID-19 continue to have symptoms for weeks, months, or even years after their infection. This is often called \"Long COVID\" or Post-Acute Sequelae of SARS-CoV-2 (PASC). For some people, Long COVID can affect the heart and lungs, making it harder to exercise or carry out daily activities. It can also affect mental health and quality of life.\n\nThis study is testing a new care model called PERCEIVE-Outreach, designed to help people living with Long COVID who may have ongoing heart or lung problems. The model involves three parts:\n\n1. Screening: A simple assessment to identify people most likely to benefit from further care, based on symptoms and activity levels.\n2. Clinical review: A thorough check of heart and lung health conducted remotely via telehealth.\n3. Personalised exercise program: A tailored program to help improve fitness and reduce time spent sitting, delivered entirely via telehealth.\n\nThe main thing this study is measuring is whether participants can walk further after 6 months compared to when they started (measured using a 6-minute walk test), which correlates well with an individuals ability to complete normal daily functions. The study will also look at quality of life, mental health, physical activity, heart function, and hospital visits over 2 years.\n\nThe study is designed with input from patients and healthcare providers to ensure it meets real-world needs. All care is delivered remotely, meaning participants can take part from home anywhere in Australia.","conditions":["Long COVID"],"keywords":["Long COVID","Exercise","PERCEIVE-Outreach","PERCEIVE","Australia","Rural Health","Cardiovascular"],"interventions":[{"type":"OTHER","name":"PERCEIVE-Outreach Disease Management Program"}],"enrollment":577,"startDate":"2026-04-01","completionDate":"2029-04-01","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged forty years or older\n* Impaired estimated functional capacity using DASI as proxy (defined by age-normative metabolic equivalent of tasks \\[METs\\])\n* History of COVID-19 (stratified by hospital admission)\n* Currently symptomatic with fatigue, dyspnoea or chest pain symptoms\n* Medicare eligibility\n* Ability and willingness to provide written informed consent to participate in the study. The patient will need to be able to communicate fluently with the investigator. The investigator will need to be satisfied that the patient understands the study by having them explain the study plan back to the investigator.\n\nExclusion Criteria:\n\n* Unable to provide written informed consent to participate in this study\n* Participating in another research trial where randomized treatment would be unacceptable\n* Mobility impairment that would impact participants' ability to perform exercise\n* History of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)\n* Known valvular stenosis or regurgitation of \\>moderate severity, history of previous heart failure (baseline New York Heart Association \\[NYHA\\] \\>2)\n* Oncologic (or other) life expectancy \\<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial","locations":[{"facility":"Menzies Insititute for Medical Research","city":"Hobart","state":"Tasmania","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baker Heart and Diabetes Institute","city":"Melbourne","state":"Victoria","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Quan Huynh, PhD","phone":"+61 03 8532 1833","email":"quan.huynh@utas.edu.au; quan.huynh@baker.edu.au"}],"primaryOutcomes":["Changes in 6-min walk distance (6MWD) at 6 months"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["hobart-australia","melbourne-australia"],"enrichment":{"headline":"Not a traditional drug phase: PERCEIVE-Outreach Disease Management Program for Long COVID","inPlainEnglish":"Some people who had COVID-19 continue to have symptoms for weeks, months, or even years after their infection. This is often called \"Long COVID\" or Post-Acute Sequelae of SARS-CoV-2 (PASC).","whoItsFor":["Ages 40 Years to any","Aged forty years or older","Impaired estimated functional capacity using DASI as proxy (defined by age-normative metabolic equivalent of tasks \\[METs\\])","History of COVID-19 (stratified by hospital admission)","Currently symptomatic with fatigue, dyspnoea or chest pain symptoms","Medicare eligibility"],"whoShouldSkip":["Participating in another research trial where randomly assigned treatment would be unacceptable","Mobility impairment that would impact participants' ability to perform exercise","History of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)","Known valvular stenosis or regurgitation of \\>moderate severity, history of previous heart failure (baseline New York Heart Association \\[NYHA\\] \\>2)","Oncologic (or other) life expectancy \\<12 months or any other medical condition (including pregnancy) that results in the belief (deemed by the Chief Investigators) that it is not appropriate for the patient to participate in this trial"],"whatHappens":"If you join, the listed intervention(s) are PERCEIVE-Outreach Disease Management Program. The registry lists allocation as randomized. Some people who had COVID-19 continue to have symptoms for weeks, months, or even years after their infection.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 577 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.236Z"},{"nctId":"NCT07662044","title":"A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus","officialTitle":"A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus (Eluminate-1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.","conditions":["Type 2 Diabetes Mellitus"],"keywords":[],"interventions":[{"type":"DRUG","name":"Elecoglipron"},{"type":"DRUG","name":"Dapagliflozin"},{"type":"DRUG","name":"Elecoglipron-matched placebo"},{"type":"DRUG","name":"Dapagliflozin-matched placebo"}],"enrollment":800,"startDate":"2026-07-06","completionDate":"2028-07-14","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening\n* T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication\n* HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)\n* Body mass index (BMI) of ≥ 23 kg/m2 at screening\n* Stable body weight (self-reported or documented) for 90 days prior to screening\n\nExclusion Criteria:\n\n* Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma\n* Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema\n* Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms\n* Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying\n* History of acute or chronic pancreatitis\n* Severe congestive heart failure (New York Heart Association IV)\n* History/family history of medullary thyroid cancer or multiple endocrine neoplasia type 2","locations":[{"facility":"Research Site","city":"Birmingham","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Daphne","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lomita","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Los Alamitos","state":"California","country":"United 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The registry lists allocation as randomized. This study wants to measure the how well it works, safety, and tolerability of elecoglipron compared with oral semaglutide in adults with T2DM and increased cardiovascular risk that is inadequately managed alone or on stable treatment with other background glucose-lowering medication(s).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,200 people at 184 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.730Z"},{"nctId":"NCT07663331","title":"A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis","officialTitle":"A Multicenter, Open-label Study on the Efficacy and Safety of Tebiovio® (Adalimumab) in Treating Chinese Children With Severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This study is a real-world clinical research on adalimumab. The project plans to enroll 30 subjects. The safety and efficacy of adalimumab injection for adult non-infectious uveitis are being investigated. The time of treatment failure for subjects at 6 weeks of treatment or between 6 and 24 weeks of treatment is the primary endpoint.","conditions":["Adult Non-infectious Uveitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"TyboWe® Adalimumab Injection"}],"enrollment":30,"startDate":"2026-07-14","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The subject must sign an informed consent form for data collection and data validation, and the research protocol/informed consent form must comply with local legal and regulatory requirements;\n* Age 18 or above, gender unrestricted;\n* Diagnosed with active non-infectious intermediate, posterior, or panuveitis, defined as the presence of at least one of the following conditions in at least one eye: active, inflammatory chorioretinopathy and/or inflammatory retinal vasculitis; ≥2+ AC cells (according to the Standardization of Uveitis Nomenclature \\[SUN\\] criteria); or ≥2+ VH (National Eye Institute/SUN criteria);\n* The subject had received oral prednisone (or equivalent corticosteroid medication) at a dose of ≥10 mg to 60 mg/day for ≥2 weeks prior to screening and remained on the same dose at baseline, with corresponding documentation provided;\n* The subject (including their partner) agrees to have no pregnancy or sperm donation plans during the entire trial period and for six months after the study concludes, and voluntarily adopts effective contraceptive measures;\n* Adult subjects with non-infectious uveitis who were prescribed TEBOV® adalimumab injection by physicians after a thorough risk/benefit assessment.\n\nExclusion Criteria:\n\n* (Based on the instructions for Tymphul® Adalimumab Injection and the judgment of the treating physician, the subject is not suitable for treatment with Tymphul® Adalimumab Injection.);\n* The subject had any of the following ocular events during screening: isolated anterior uveitis; confirmed or suspected infectious uveitis; ocular masquerade syndrome, such as ocular lymphoma; ocular histoplasmosis syndrome; serpiginous choroidopathy; scleritis; corneal or lens opacity impairing fundus visualization or requiring cataract surgery during the trial; macular edema as the sole sign of uveitis; severe VH impairing fundus visualization at baseline; intraocular pressure ≥25 mmHg with use of ≥2 glaucoma medications or evidence of glaucomatous optic neuropathy; best-corrected visual acuity (BCVA) of less than 20 letters (ETDRS) in either eye at baseline; proliferative or severe nonproliferative diabetic retinopathy or clinically significant macular edema caused by diabetic retinopathy; neovascular (wet) age-related macular degeneration; vitreoretinal interface abnormalities (e.g., vitreomacular traction, epiretinal membrane, etc.) that may lead to macular structural damage unrelated to inflammatory processes; ocular surgery performed within 90 days prior to the baseline visit, excluding refractive laser surgery, retinal laser photocoagulation, or Yttrium Aluminum Garnet (YAG) (neodymium-doped yttrium-aluminum-garnet) posterior capsulotomy;\n* The subject has any of the following medical conditions or diseases: current or past history of demyelinating diseases (including multiple sclerosis and optic neuritis) or neurological symptoms indicative of demyelinating diseases, including but not limited to optic neuritis; current or past history of systemic lupus erythematosus; arrhythmia (QTc ≥450ms for males, QTc ≥470ms for females); moderate to severe congestive heart failure (New York Heart Association Class III-IV); recent cerebrovascular accident and any other medical history deemed by the investigator to pose a risk to the subject's participation in the study; any malignant tumor (except successfully treated non-melanoma skin cancer or localized cervical carcinoma in situ); any other clinically significant medical condition that the investigator deems to interfere with the subject's participation in the study or render the subject ineligible for the investigational drug, or any other reason;\n* Individuals allergic to the active ingredients (and their excipients) and/or similar products;\n* During the screening period or baseline visit, individuals with systemic inflammatory diseases requiring continued oral corticosteroid therapy or immunosuppressive treatment;\n* Infections requiring intravenous antimicrobial treatment within 30 days prior to the baseline visit, or infections requiring oral antimicrobial treatment within 14 days prior to the baseline visit;\n* Within 30 days prior to the baseline, an increase in the dose of other concomitant immunosuppressive therapy or failure to meet any of the following conditions: methotrexate (MTX) ≤25 mg/week; cyclosporine ≤4 mg/kg/day; mycophenolate (or equivalent dose of mycophenolic acid) ≤2 g/day; azathioprine ≤175 mg/day; tacrolimus oral ≤8 mg/day;Subjects who have received any live vaccine within 3 months prior to the first dose of Tadabow® Adalimumab injection, or who plan to receive live vaccines during the study;(7) Subjects currently participating in other clinical studies;\n* Subjects deemed unsuitable for participation in this trial by the investigator.\n* Within 90 days prior to baseline, intravitreal injection of anti Vascular Endothelial Growth Factor (VEGF) therapy (such as ranibizumab, aflibercept, or conbercept) has been administered;\n* Within 90 days prior to baseline, methotrexate was injected into the vitreous body for treatment;\n* Ozurdex implantation (dexamethasone implantation) was performed within 6 months prior to baseline;\n* Have received treatment with anti-tumor necrosis factor TNF or other potential therapeutic agents for uveitis within the past 6 months (excluding intravitreal injection of anti VEGF drugs);\n* After receiving the first dose of Taibowei ® Individuals who have received any live vaccine within the past 3 months prior to Adalimumab injection, or those who plan to receive a live vaccine during the study period;\n* Participants who are currently participating in other clinical studies;\n* Researchers believe that participants who are not suitable to participate in this trial.","locations":[{"facility":"Tianjin Medical University Eye Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Manli Li, Doctor","phone":"15093292527","email":"343507699@qq.com"}],"primaryOutcomes":["Time of treatment failure in subjects"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":["adalimumab"],"locationSlugs":["tianjin-china"],"enrichment":{"headline":"Phase 4: testing TyboWe® Adalimumab Injection for Adult Non-infectious Uveitis","inPlainEnglish":"This study is a real-world clinical research on adalimumab. The safety and how well it works of adalimumab injection for adult non-infectious uveitis are being investigated.","whoItsFor":["Ages 18 Years to any","Age 18 or above, gender unrestricted;","The subject had received oral prednisone (or equivalent corticosteroid medication) at a dose of ≥10 mg to 60 mg/day for ≥2 weeks prior to screening and remained on the same dose at baseline, with corresponding documentation provided;","The subject (including their partner) agrees to have no pregnancy or sperm donation plans during the entire trial period and for six months after the study concludes, and voluntarily adopts effective contraceptive measures;","Adult subjects with non-infectious uveitis who were prescribed TEBOV® adalimumab injection by physicians after a thorough risk/benefit assessment"],"whoShouldSkip":["(Based on the instructions for Tymphul® Adalimumab Injection and the judgment of the treating physician, the subject is not suitable for treatment with Tymphul® Adalimumab Injection.);","Individuals allergic to the active ingredients (and their excipients) and/or similar products;","During the screening period or baseline visit, individuals with systemic inflammatory diseases requiring continued oral corticosteroid therapy or immunosuppressive treatment;","Infections requiring intravenous antimicrobial treatment within 30 days prior to the baseline visit, or infections requiring oral antimicrobial treatment within 14 days prior to the baseline visit;","Subjects deemed unsuitable for participation in this trial by the investigator","Within 90 days prior to baseline, intravitreal injection of anti Vascular Endothelial Growth Factor (VEGF) therapy (such as ranibizumab, aflibercept, or conbercept) has been administered;","Within 90 days prior to baseline, methotrexate was injected into the vitreous body for treatment;"],"whatHappens":"If you join, the listed intervention(s) are TyboWe® Adalimumab Injection. The registry lists allocation as na. This study is a real-world clinical research on adalimumab.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 30 people at Tianjin. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.268Z"},{"nctId":"NCT07663526","title":"Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®","officialTitle":"A Multicenter, Single-Arm Study to Evaluate the Effectiveness and Safety of Tabellvi® (Adalimumab) in Chinese Adult Subjects With Moderate to Severe Active Crohn's Disease in the Real-World Setting","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled. The primary endpoints include the incidence rates of adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs) and serious ADRs, as well as the proportion of subjects achieving clinical remission (CDAI score \\< 150) at Week 26.","conditions":["Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"TyboWe® Adalimumab Injection"}],"enrollment":50,"startDate":"2026-09-23","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The subject must sign the informed consent form.\n* Aged 18 to 70 years inclusive, no gender restriction.\n* Subjects with definite diagnosis of Crohn's disease in accordance with Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (Guangzhou, 2023), presenting moderate to severe active Crohn's disease with inadequate response, intolerance or contraindication to adequate glucocorticoid and/or immunosuppressant therapy.\n* Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment.\n* Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator.\n\nExclusion Criteria:\n\n* Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician.\n* Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period.\n* Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection.\n* Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis).\n* Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose.\n* Subjects with active tuberculosis infection; or latent tuberculosis infection without adequate treatment; subjects infected with human immunodeficiency virus (HIV); subjects positive for hepatitis C virus antibody (HCV Ab) indicating previous or current infection; subjects positive for hepatitis B surface antigen (HBsAg), or positive for total hepatitis B core antibody (total Hepatitis B core Ab) with positive hepatitis B virus (HBV)-DNA polymerase chain reaction test result.\n* Subjects with syphilis infection requiring treatment.\n* Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study.\n* Subjects with current evidence of dysplasia or a history of malignant tumors (including lymphoma and leukemia), except cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized cervical carcinoma in situ.\n* Subjects with a history of demyelinating diseases (including myelitis), or neurological symptoms suggestive of demyelinating diseases.\n* Subjects who have undergone intestinal resection within the past 6 months, or plan to undergo intestinal resection at any time in the future.\n* Subjects receiving total parenteral nutrition (TPN), or planning to receive TPN at any time during the study period.\n* Subjects with an ostomy or an ileal pouch-anal anastomosis (IPAA) pouch.\n* Subjects with internal or external fistulas, except perianal fistulas without abscess.\n* Subjects with known symptomatic obstructive intestinal strictures.\n* Subjects diagnosed with ulcerative colitis or indeterminate colitis.\n* Subjects with any of the following abnormal laboratory or other examination results during the screening period: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 1.5 times the upper limit of the reference range; white blood cell count \\< 3.0×10⁹/L; electrocardiogram (ECG) with clinically significant abnormalities; total bilirubin ≥3 mg/dL (isolated elevated indirect bilirubin caused by Gilbert's syndrome excluded); serum creatinine \\>1.6 mg/dL.\n* Subjects with other clinically significant abnormal laboratory test results (other than those listed above) identified by the investigator during screening.\n* Subjects who have received other tumor necrosis factor-alpha (TNF-α) inhibitor therapy within 12 weeks before receiving the first dose of Tabellvi® Adalimumab Injection.\n* Subjects currently participating in another clinical study.\n* Subjects deemed unsuitable for participation in this trial by the investigator.","locations":[{"facility":"Fuyang People's Hospital","city":"Fuyang","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhoukou Central Hospital","city":"Zhoukou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huai'an First People's Hospital","city":"Huaian","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yancheng No.1 People's Hospital","city":"Yancheng","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Meihekou Central Hospital","city":"Meihekou","state":"Jilin","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Jiao Tong University School of Medicine, Renji Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jun Shen, Doctor","phone":"13651829887","email":"shenjun@vip.163.com"}],"primaryOutcomes":["Serious Adverse Event (SAE)","Adverse Event (AE)","Adverse Drug Reaction (ADR)","Serious Adverse Drug Reaction","Clinical remission (CDAI < 150)"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["fuyang-china","zhengzhou-china","zhoukou-china","huaian-china","yancheng-china","meihekou-china","shanghai-china"],"enrichment":{"headline":"Phase 4: testing TyboWe® Adalimumab Injection for Crohn's Disease","inPlainEnglish":"This is a post-marketing real-world study designed to measure the how well it works and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial. A total of 50 subjects are planned to be enrolled.","whoItsFor":["Ages 18 Years to 70 Years","Aged 18 to 70 years inclusive, no gender restriction","Adult patients with Crohn's disease who are prescribed Tabellvi® Adalimumab Injection by physicians following thorough risk-benefit assessment","Female subjects of childbearing potential must agree to use one contraceptive method approved by the investigator"],"whoShouldSkip":["Subjects who are not suitable for treatment with Tabellvi® Adalimumab Injection based on the prescribing information of Tabellvi® Adalimumab Injection and the judgment of the treating physician","Female subjects who are pregnant or breastfeeding, or who plan to become pregnant during the study period","Subjects with hypersensitivity to any component of Tabellvi® Adalimumab Injection","Subjects with active, chronic or recurrent infections, or a medical history of invasive infections (e.g., listeriosis, histoplasmosis)","Subjects with active infections requiring intravenous anti-infective therapy within 30 days prior to the first dose, or those who have received oral anti-infective drugs within 14 days prior to the first dose","Subjects with syphilis infection requiring treatment","Subjects with moderate to severe heart failure (NYHA Class III/IV), recent cerebrovascular accident, or other medical conditions that may put the subject at risk by participating in this study"],"whatHappens":"If you join, the listed intervention(s) are TyboWe® Adalimumab Injection. The registry lists allocation as na. This is a post-marketing real-world study designed to measure the how well it works and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 50 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.266Z"},{"nctId":"NCT07664579","title":"Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer","officialTitle":"Investigating the Feasibility and Acceptability of an Innovative Interdisciplinary Supportive Care Program: Couples Coping Together Against Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This study evaluates how useful and acceptable the components of the \"Couples Coping Together Against Cancer\", referred to as \"The Program\", are to the participants with cancer.","conditions":["Anatomic Stage IV Breast Cancer AJCC v8","Glioblastoma","Lung Carcinoma","Malignant Solid Neoplasm","Metastatic Breast Carcinoma"],"keywords":[],"interventions":[{"type":"OTHER","name":"Non-Interventional Study"}],"enrollment":160,"startDate":"2024-07-05","completionDate":"2027-01-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Have received a diagnosis of a primary brain tumor (glioblastoma), or other cancers (breast, lung, etc.)\n* Are new patients to City of Hope (COH) (all sites) or receive at least some of their care at City of Hope- Duarte Campus (care is defined as: procedures, consults, laboratories, imaging, surgery, and/or treatment)\n* The patient is in a committed relationship/partnership with a partner and the partner is available and willing to participate\n* Are English or Spanish speaking\n* ≥ 18 years of age\n* Have access to a smartphone, computer/laptop or internet connection to complete all study procedures\n\nExclusion Criteria:\n\n* Significant cognitive impairment\n* Inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)\n* Visual, hearing, voice, or motor impairment that prevents completion of study procedures as evidenced by clinical judgment\n* Committed partners will be excluded from the study if they:\n\n  * Refuse to complete informed consent\n  * Have cognitive impairment\n  * Have severe mental illness that would prevent informed consent and completion of study activities as evidenced by clinical judgment","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Accrual rate (AR)","Retention rate (RR)","Adherence rate (AdR)","Study Satisfaction (SS)"],"hasResults":false,"conditionSlugs":["breast-cancer","glioblastoma"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Not a traditional drug phase: Non-Interventional Study for Anatomic Stage IV Breast Cancer AJCC v8","inPlainEnglish":"This study evaluates how useful and acceptable the components of the \"Couples Coping Together Against Cancer\", referred to as \"The Program\", are to the participants with cancer.","whoItsFor":["Ages 18 Years to any","Have received a diagnosis of a primary brain tumor (glioblastoma), or other cancers (breast, lung, etc.)","Are new patients to City of Hope (COH) (all sites) or receive at least some of their care at City of Hope- Duarte Campus (care is defined as: procedures, consults, laboratories, imaging, surgery, and/or treatment)","Are English or Spanish speaking","Have access to a smartphone, computer/laptop or internet connection to complete all study procedures"],"whoShouldSkip":["Significant cognitive impairment","Inpatient psychiatric treatment for severe mental illness or overt signs of severe psychopathology (e.g., psychosis)","Visual, hearing, voice, or motor impairment that prevents completion of study procedures as evidenced by clinical judgment","Committed partners will be excluded from the study if they:","Have cognitive impairment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 160 people at Duarte. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.972Z"},{"nctId":"NCT07664852","title":"Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression","officialTitle":"B-HAPPI: Bipolar Disorder and High-dose Adjunctive Pramipexole in Anhedonic Depression - a Phase III, Double-blind, Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Daniel Lindqvist","sponsorClass":"OTHER","summary":"Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide. B-HAPPI is an academic randomized controlled trial to evaluate a new medication for bipolar depression. It will investigate the efficacy and safety of pramipexole, a potent dopamine agonist that has demonstrated significant effectiveness in bipolar disorder in preliminary studies, showing large effect sizes.\n\n* Population: 126 patients with bipolar depression\n* Intervention: Pramipexole added to ongoing treatment with mood stabilizer, flexible dosing - target dose 2.1 mg/day\n* Control: Add-on identical placebo\n* Outcomes: Primary outcome is change in anhedonia symptoms between baseline and 6 weeks of intervention. Key secondary outcomes include (for example) general depression symptoms and safety measures.\n\nThere will be a 15 weeks open label follow up. If shown to be effective and safe, this intervention could become a key treatment option for bipolar depression, reducing suffering and potentially lowering suicide risk.","conditions":["Bipolar Disorder (BD)"],"keywords":["Randomized controlled trial","Pramipexole","Dopamine agonist","Anhedonia"],"interventions":[{"type":"DRUG","name":"Pramipexole"},{"type":"DRUG","name":"Placebo"}],"enrollment":126,"startDate":"2026-10","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* The participant has given their written consent to participate in the trial.\n* For WOCBP, adequate contraception should be used (see section 9.6) and a negative pregnancy test is (u-hCG) required. WOCBP: For the purpose of this protocol, a woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.\n* Age ≥18 years ≤80 years.\n* Diagnosis of bipolar disorder type I or II as verified by ICD-11.\n* Ongoing depressive state according to ICD-11 (at least 2 weeks, maximum 18 months).\n* Significant anhedonia, defined as 3 or 4 points on ≥3 items on the SHAPS self-rating scale\n* Minimum score on the MADRS expert rating scale ≥ 20\n* Ongoing treatment with at least one mood stabilising agent (with sufficient antimanic protection as determined by clinical judgment). If treatment with lithium is ongoing, serum levels must be within the reference range of 0.4-0.9. The latest concentration measurement should be within one month before treatment initiation. If treatment is ongoing with a mood stabilising anticonvulsant or an antipsychotic, any dose adjustments made within 4 weeks prior to study start must be reported. Mood-stabilising anticonvulsants and antipsychotics must not be newly initiated within 4 weeks prior to study start. If treatment with antidepressants is ongoing the dose must have been stable for at least 4 weeks.\n\nExclusion Criteria:\n\n* Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification.\n* Meets criteria for a mixed episode according to ICD-11.\n* High suicide risk according to the overall clinical assessment of the research physician.\n* Ongoing substance abuse (within 6 months).\n* Ongoing psychotic symptoms.\n* Prior diagnosis of schizophrenia or schizoaffective disorder.\n* Clinical presentation is primarily attributable to a personality disorder.\n* Subject to compulsory psychiatric care (LPT).\n* History of, or strong clinical suspicion of, impulse control disorder (including current binge-eating disorder). A diagnosis of ADHD is not, in itself, an exclusion criterion; however, participants will be excluded if the clinical presentation is primarily characterised by impulse control-related symptoms.\n* Diagnosis of intellectual disability, dementia, cognitive impairment, or other conditions (including those related to the depressive disorder itself) that, in the judgment of the study physician, may substantially impair the participant's ability to understand the study and provide informed consent.\n* Diagnosis of renal failure (eGFR \\<50 ml/min/1.73m2) or severe cardiovascular disease (specifically symptomatic heart failure \\>Class II New York Heart Association (NYHA)).\n* Recently started psychotherapy (within 6 weeks) or planning to start such treatment during participation in the trial. Psychoeducational treatment, which is standard care at bipolar units, is not an exclusion criterion.\n* Ongoing treatment with ECT, ketamine or rTMS.\n* Other medical conditions, other ongoing interventions or other concomitant drug treatment (see section 7.3) that, in the opinion of the investigators, may affect the evaluability of the trial or conditions that increase trial risk. For example: Parkinson's disease, hepatic insufficiency, ongoing cancer not in remission for more than one year.\n* Known or suspected allergy to any active substance or excipient in the medicinal product included in the trial.\n* Participation in other treatment studies.\n* Other reason, as assessed by the investigator, that prevents the research participant's participation, such as the risk that the research participant is unable to complete the trial (non-compliance).","locations":[{"facility":"Adult Psychiatry","city":"Lund","state":"Skåne County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mirjam Wolfschlag, PhD","phone":"+46724596431","email":"mirjam_katharina.wolfschlag@med.lu.se"}],"primaryOutcomes":["Change in Snaith-Hamilton Pleasure Scale (SHAPS) self-reported total score after 6 weeks of treatment compared to baseline"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["lund-sweden"],"enrichment":{"headline":"Phase 3: testing Pramipexole for Bipolar Disorder (BD)","inPlainEnglish":"Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates. This condition presents unique management challenges, especially during its depressive phase, which carries the highest risk of suicide.","whoItsFor":["Ages 18 Years to 80 Years","The participant has given their written consent to participate in the trial","Age ≥18 years ≤80 years","Diagnosis of bipolar disorder type I or II as verified by ICD-11","Ongoing depressive state according to ICD-11 (at least 2 weeks, maximum 18 months)","Significant anhedonia, defined as 3 or 4 points on ≥3 items on the SHAPS self-rating scale","Minimum score on the MADRS expert rating scale ≥ 20"],"whoShouldSkip":["Pregnancy, breastfeeding or planned pregnancy (if female). See also section 8.6 below for clarification","Meets criteria for a mixed episode according to ICD-11","High suicide risk according to the overall clinical assessment of the research physician","Ongoing substance abuse (within 6 months)","Ongoing psychotic symptoms","Prior diagnosis of schizophrenia or schizoaffective disorder","Clinical presentation is primarily attributable to a personality disorder"],"whatHappens":"If you join, the listed intervention(s) are Pramipexole, or Placebo. The registry lists allocation as randomized. Among psychiatric disorders, bipolar disorder stands out due to its alarmingly high suicide rates.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 126 people at Lund. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.741Z"},{"nctId":"NCT07665450","title":"A Study of Ramantamig Plus Daratumumab Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With NDMM For Whom Stem Cell Transplant is Not Planned","officialTitle":"A Phase 3 Randomized Study Comparing Ramantamig Plus Daratumumab Versus Investigator's Choice of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (DVRd) or Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \\[WBCs\\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ramantamig"},{"type":"DRUG","name":"Daratumumab"},{"type":"DRUG","name":"Lenalidomide"},{"type":"DRUG","name":"Bortezomib"},{"type":"DRUG","name":"Dexamethasone"}],"enrollment":1000,"startDate":"2026-09-09","completionDate":"2030-09-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria\n* Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT\n* Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2\n* Must sign an informed consent form (ICF)\n* Measurable disease at screening as assessed by central laboratory as defined in the protocol\n\nExclusion criteria:\n\n* Myeloma Frailty Score of greater than or equal to (\\>=) 2 with the exception of participants who have a score of 2 based on age alone\n* Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients\n* Had major surgery (for example, requiring general anesthesia) or had significant traumatic injury within 2 weeks prior to first dose of trial intervention or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the trial\n* Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM\n* Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of 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3: testing Ramantamig for Multiple Myeloma","inPlainEnglish":"The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \\[WBCs\\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.","whoItsFor":["Ages 18 Years to any","Documented diagnosis of multiple myeloma (MM) according to the IMWG diagnostic criteria","Not considered for high-dose chemotherapy with autologous stem cell transplantation (ASCT) due to: i. ineligible due to advanced age; or ii. ineligible due to presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT","Have an eastern cooperative oncology status (ECOG) performance status of 0 to 2","Measurable disease at screening as assessed by central laboratory as defined in the protocol"],"whoShouldSkip":["Myeloma Frailty Score of greater than or equal to (\\>=) 2 with the exception of participants who have a score of 2 based on age alone","Suspected or known allergies, hypersensitivity, intolerance or other contraindications to any trial intervention or its excipients","Known active or prior CNS involvement or exhibits clinical signs of meningeal involvement of MM","Received any prior therapy(ies) for treatment of MM or smoldering myeloma, with the exception of emergency use of a short course of corticosteroids"],"whatHappens":"If you join, the listed intervention(s) are Ramantamig, Daratumumab, or Lenalidomide. The registry lists allocation as randomized. The main purpose of this study is to see how well a new treatment ramantamig-D works compared to standard treatments that is either DVRd or DRd on progression-free survival (PFS; time until a participant's disease worsens) and 12-month minimal residue disease (MRD)-negative complete response (CR) rate (percentage of participants in whom cancer cells are not detected) in participants with newly diagnosed multiple myeloma (NDMM; an initial stage of blood cancer that forms in a type of white blood cells \\[WBCs\\] called plasma cells) for whom stem cell transplant is not planned as initial therapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.520Z"},{"nctId":"NCT07665515","title":"Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer","officialTitle":"A Phase I/Ib, Multi-centre, Open-label Study to Evaluate the Safety, Tolerability, and Immunogenicity of CryptiVax-1001, a mRNA Lipid Nanoparticle Therapeutic Cancer Vaccine, in Participants With FIGO Stage III-IV High-Grade Serous or Predominantly Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Following Optimal Primary/Interval Debulking Surgery and First-Line Platinum-Based Chemotherapy (OVACT Study)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Epitopea Ltd","sponsorClass":"INDUSTRY","summary":"Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.\n\nThe main purpose of this study is to understand whether an experimental study vaccine, CryptiVax-1001, is safe when administered to patients with high-grade serous ovarian cancer (HGSOC). The study vaccine is a cancer vaccine, which aims to delay or possibly prevent the cancer from coming back. However, as this is the first study of the vaccine in patients, the primary purpose of this study is to assess the safety of the study vaccine.\n\nFollowing surgery and platinum-based chemotherapy participants may enter the trial and receive CryptiVax-1001 as an explorative maintenance therapy.\n\nThe main purposes of this study are therefore to:\n\n* assess how well the study vaccine is tolerated and identify any side effects.\n* analyse the study vaccine's capacity to activate your immune system\n\nThe study will test escalating dose levels of CryptiVax-1001 based on the safety evaluations to estimate appropriate future dose levels for CryptiVax-1001.","conditions":["Ovarian Cancer","HGSOC","HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer"],"keywords":["ovarian cancer","Maintenance","FIGO stage III-IV","HRP","BRCAwt","mRNA vaccine","CryptiVax-1001"],"interventions":[{"type":"BIOLOGICAL","name":"CryptiVax-1001"}],"enrollment":50,"startDate":"2026-11-05","completionDate":"2029-03","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Able to comprehend and are willing to sign the ICF and willing to follow the study procedures\n* Female, aged 18 years of age or older at the time of informed consent.\n* Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes\n* The FIGO 2014 stage III or IV disease at initial diagnosis.\n* Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)\n* Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings).\n* In the presence of measurable target lesion, achieved CR or PR per investigator assessment based on RECIST 1.1 after completion of chemotherapy. In the absence of measurable target lesion, no new lesion or overt progression per investigator assessment based on RECIST 1.1 after completion of chemotherapy.\n* A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy.\n* No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening.\n* Known BRCAwt status.\n* HRP confirmed\n* No prior, current, or planned treatment with bevacizumab or PARPi in the first-line maintenance setting.\n* ECOG performance status of 0 or 1.\n* Adequate haematologic and organ function\n* Negative pregnancy test for WOCBP.\n* HLA type matching Cryptivax-1001\n\nExclusion Criteria:\n\n* Non-epithelial or low malignant potential ovarian tumours\n* Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening.\n* Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death\n* Active autoimmune disease requiring systemic immunosuppression\n* Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments\n* History of anaphylactic reaction to mRNA-LNP therapies.\n* Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy.\n* Administration of any vaccine within 30 days prior to first dosing.\n* Participation in a clinical study involving administration of an IMP (new chemical entity) in the past 90 days or 5 half-lives of that drug (if known) prior to first dosing, whichever is longer.","locations":[{"facility":"Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital","city":"Cambridge","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Edinburgh - Western General Hospital - Edinburgh Cancer Research Centre","city":"Edinburgh","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Beatson West of Scotland Cancer Centre","city":"Glasgow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. James's University Hospital","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospitals of Leicester NHS Trust -Leicester Royal Infirmary","city":"Leicester","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals NHS Foundation Trust - Cancer Clinical Trials Unit","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden NHS Foundation Trust - Royal Marsden Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital","city":"Preston","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Marsden NHS Foundation Trust - Institute of Cancer Research","city":"Sutton","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Head of Development Operations","phone":"+4530660105","email":"Gertrud.Rasmussen@epitopea.com"},{"name":"Head of Oncology Development","phone":"+4795113393","email":"Siri.Torhaug@Epitopea.com"}],"primaryOutcomes":["To evaluate the safety and tolerability of CryptiVax-1001","To evaluate the safety and tolerability of CryptiVax-1001","To evaluate the safety and tolerability of CryptiVax-1001","To evaluate the safety and tolerability of CryptiVax-1001"],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":[],"locationSlugs":["cambridge-united-kingdom","edinburgh-united-kingdom","glasgow-united-kingdom","leeds-united-kingdom","leicester-united-kingdom","london-united-kingdom","preston-united-kingdom","sutton-united-kingdom"],"enrichment":{"headline":"Phase 1: testing CryptiVax-1001 for Ovarian Cancer","inPlainEnglish":"Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer. The most common and aggressive form is called high-grade serous ovarian cancer.","whoItsFor":["Ages 18 Years to any","Women only","Able to comprehend and are willing to sign the ICF and willing to follow the study procedures","Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma of high-grade serous histology or other high-grade predominantly serous subtypes","The FIGO 2014 stage III or IV disease at initial diagnosis","Underwent optimal PDS or IDS with residual disease ≤1 cm (R0 or R1 resection)","Completed first-line platinum-based chemotherapy (minimum 4 cycles of carboplatin and paclitaxel, or equivalent, received in either neoadjuvant or adjuvant, or both settings)","A minimum of 4 weeks from screening since the last dose of first-line platinum-based chemotherapy but not more than 12 weeks from screening since the last dose of first-line platinum-based chemotherapy","No evidence of radiologic or clinical progression between the end of chemotherapy and baseline screening"],"whoShouldSkip":["Non-epithelial or low malignant potential ovarian tumours","Presence of uncontrolled ascites or pleural effusion requiring drainage within 4 weeks of screening","Concurrent malignancy or history of another malignancy within the past 3 years except for malignancies with a negligible risk of metastasis or death","Active autoimmune disease requiring systemic immunosuppression","Uncontrolled intercurrent illness that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments","History of anaphylactic reaction to mRNA-LNP therapies","Previous treatment with any cancer vaccine, checkpoint inhibitor, or adoptive cellular immunotherapy"],"whatHappens":"If you join, the listed intervention(s) are CryptiVax-1001. The registry lists allocation as randomized. Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at 10 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.153Z"},{"nctId":"NCT07667400","title":"Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","officialTitle":"Phase I/II Trial of Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"National Cancer Institute (NCI)","sponsorClass":"NIH","summary":"Background:\n\nHead and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands. Prostate cancer is the most common cancer in men in the United States. Survival rates for these cancers are lower than 50% if they spread to other parts of the body or return after treatment. Better treatments are needed.\n\nObjective:\n\nTo test a new drug (SX-682), combined with an approved drug (docetaxel, or DTX), in people with HNCs or prostate cancer.\n\nEligibility\n\nPeople aged 18 years and older with an HNC or prostate cancer that has returned after treatment or has spread.\n\nDesign:\n\nParticipants will be screened. They will have blood tests, imaging scans, and a test of their heart function. A tissue sample (biopsy) of the tumor may be taken.\n\nParticipants will take the study drugs in 3-week cycles. SX-682 is a tablet taken by mouth twice a day from Days 1 to 11 of each cycle. Participants will get a supply of the drug to take home. DTX is given on Day 8 of each cycle through a tube attached to a needle inserted into a vein in the arm. Participants will come to the clinic on Days 1 and 8 of every cycle. They will take both drugs for up to 6 cycles.\n\nParticipants will have follow-up visits 1 week and 1 month after they finish taking the drugs. Follow-ups will continue every 3 months for 2 years. Then they will have phone or email check-ins twice a year until 5 years have passed.","conditions":["Head and Neck Cancer","Head and Neck Squamous Cell Carcinoma","Paranasal Sinus Neoplasms","Nasopharyngeal Carcinoma","Oropharyngeal Squamous Cell Carcinoma","Hypopharyngeal Cancer","Carcinoma of Larynx","Oral Squamous Cell Carcinoma","Salivary Gland Cancer","Adenoid Cystic Carcinoma","Prostate Cancer","Metastatic Castration Resistant Prostate Cancer"],"keywords":["Solid Tumors","Infusion","Chemotherapy","Carcinoma","Head and Neck","Prostate","molecule inhibitor"],"interventions":[{"type":"DRUG","name":"SX-682"},{"type":"DRUG","name":"DTX"}],"enrollment":120,"startDate":"2026-11-15","completionDate":"2036-10-01","sex":"ALL","minAge":"18 Years","maxAge":"120 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nAll Participants\n\n* Age \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\<= 2\n* Participants must have adequate organ and marrow function as defined below:\n\n  * ANC \\>= 1,500/mcL\n  * Hemoglobin (Hgb) \\>= 9 g/dL\n  * Platelets (PLTs) \\>= 100,000/mcL\n  * Creatinine clearance \\>= 50 mL/min (by Cockroft-Gault formula)\n  * Total bilirubin \\<= 1.5 x iULN (\\<= 3 x ULN in participants with known/suspected Gilbert s disease)\n  * ALT/AST \\<= 2.5 x iULN\n  * Activated partial thromboplastin time (aPTT) \\<= 1.5 x iULN\n* Contraception as follows:\n* Women of child-bearing potential (WOCBP) must agree to use an effective method of contraception (barrier, hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) prior to study entry, for the duration of study treatment, and for up to 2 months after discontinuation of the study drugs. A participant may request a male partner to use an effective form of contraception to fulfill this requirement.\n* Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) for the duration of the study treatment and up to 4 months after discontinuation of the study drugs. A participant may request a female partner to use an effective form of contraception to fulfill this requirement. Men able to father a child must not freeze or donate sperm within the same period.\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through one week after the last dose of study drugs.\n* Participants must be able to swallow oral medications.\n* Human immunodeficiency virus (HIV)-infected participants must have undetectable viral load (VL) and be on effective anti-retroviral therapy within 4 weeks prior to the study treatment initiation and have no history of opportunistic infections or Castleman s disease within 12 months prior to the study treatment initiation.\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV VL.\n* Participants with evidence of chronic hepatitis C virus (HCV) infection must have undetectable HCV VL.\n* Participants must be able to understand and willing to sign a written informed consent document.\n\nParticipants with HNC\n\n* Histologically confirmed HNSCC (including oral cavity, oropharynx, larynx, hypopharynx, paranasal sinuses, nasopharynx) or SGC (including ACC and non-ACC) and recurrent/metastatic (R/M) or advanced incurable disease.\n* Prior treatment as follows:\n\n  * Participants with R/M HNSCC must have prior systemic treatment (platinum-based chemotherapy and/or anti-PD(L)1 treatment).\n  * Participants with R/M SGC may have any number of prior systemic treatment lines; prior systemic treatment not required for participation.\n  * Participants must not have received systemic anticancer treatment within 3 weeks prior to first treatment administration. Note: Treatment-related toxicities must have resolved to Grade \\<2 or be minimal and not constitute a safety risk. Participants with SGC previously treated with hormonal therapies (e.g., drugs targeting the androgen receptor) may continue these drugs concomitantly with study therapy. Participants with bone metastases or hypercalcemia on intravenous bisphosphonate medications, denosumab, or similar agents, are eligible to participate and may continue this treatment.\n* Presence of \\>= 1 measurable lesion by RECIST v 1.1 criteria.\n\nParticipants with mCRPC\n\n* Documented histopathological confirmation of prostate cancer. If no pathologic report or specimen is available, participants may enroll with a history of clinical course consistent with the disease.\n* Participants must have mCRPC, defined as at least one lesion on TC-99 bone scan or at least one lesion that is measurable per RECIST 1.1.\n* Participants must need ADT as part of their cancer therapy (unless previous orchiectomy)\n* Castrate testosterone level (\\<50 ng/dl or 1.7 nmol/L)\n* Prior treatment as follows:\n\n  * DTX for mCRPC is allowed but participants must not have had progression while on docetaxel or within 3 months after completing DTX for mCRPC\n  * Participants must have been previously treated with modern anti-androgens such as abiraterone, enzalutamide, apalutamide, or darolutamide.\n* Progression defined as two consecutive rising PSA values at least 1 week apart or radiographic evidence of progression seen on computed tomography (CT) scan or TC- 99 bone scan.\n* Toxicities related to prior therapy, including surgery and/or radiation, must have resolved to \\< Grade 1 per CTCAE v.6.0.\n\nEXCLUSION CRITERIA:\n\nAll participants\n\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80).\n* Known active brain metastases. Note: Participants with previously treated brain metastases are eligible if imaging at least four weeks prior to first trial treatment shows no evidence of progression and neurologic symptoms have resolved, have no new or enlarging brain metastases, and are not using glucocorticoids for at least a week prior to first trial treatment\n* Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s).\n* Participants must not have received major surgery within 14 days prior to the first drug administration (minimally invasive procedures such as diagnostic biopsies are permitted). If participant underwent major surgery, they must have recovered adequately (according to the Principal Investigator) from the toxicity and/or complications from the intervention prior to starting study treatment.\n* Treatment (systemic) with any medications or substances that are moderate or strong inducers or moderate or strong inhibitors of cytochrome P450 (CYP3A4) listed at https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-druginteractions- table-substrates-inhibitors-and-inducers#table2-2,table3-3,table5-2 within 2 weeks or 5 half-lives (whichever is shorter) prior to the start of the study treatment.\n* Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or efficacy assessment of the study treatment.\n* Participants with serious uncontrolled intercurrent illness evaluated by medical history, electrocardiogram (EKG), and physical exam that would unacceptably increase risk for the participant or impair the ability to evaluate the endpoints of the study or that would limit compliance with study requirements.\n\nParticipants with HNC\n\n* Participants must not have received large-field radiotherapy within 2 weeks prior to first treatment administration. All residual treatment-related toxicities must have resolved to Grade \\<2 (except for radiation-induced xerostomia/dysgeusia) or be minimal and not constitute a safety risk.\n* Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test\n\nParticipants with mCRPC\n\n* Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation.\n* Cancer related neuropathy at screening\n* Baseline QTcF \\>= 470 ms","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michele L Reed, R.N.","phone":"(240) 760-6121","email":"michele.reed@nih.gov"},{"name":"Charalampos Floudas, M.D.","phone":"(240) 474-1575","email":"charalampos.floudas@nih.gov"}],"primaryOutcomes":["Phase I: To determine the RP2D of SX-682 in combination with DTX in participants with HNSCC, SGC, or mCRPC","Phase II: To determine the efficacy of the combination of SX-682 and DTX in participants with HNSCC or SGC using ORR per RECIST v 1.1 or with mCRPC using RECIST v1.1 and Prostate Cancer Working Group 3"],"hasResults":false,"conditionSlugs":["prostate-cancer","head-and-neck-cancer"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing SX-682 for Head and Neck Cancer","inPlainEnglish":"Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide. They grow in the mouth, throat, nasal cavity, or salivary glands.","whoItsFor":["Ages 18 Years to 120 Years","Eastern Cooperative Oncology Group (ECOG) performance status (PS) \\<= 2","Participants must have adequate organ and marrow function as defined below:","Hemoglobin (Hgb) \\>= 9 g/dL","Platelets (PLTs) \\>= 100,000/mcL","Creatinine clearance \\>= 50 mL/min (by Cockroft-Gault formula)","Total bilirubin \\<= 1.5 x iULN (\\<= 3 x ULN in participants with known/suspected Gilbert s disease)","ALT/AST \\<= 2.5 x iULN"],"whoShouldSkip":["History of allergic reactions attributed to compounds of similar chemical or biologic composition to DTX, SX-682, or other agents used in study (e.g., polysorbate 80)","Participants must not have received other investigational agents within 3 weeks prior to the first dose of the study drug(s)","Prior or concurrent malignancy whose natural history or treatment has potential to interfere with the safety or how well it works assessment of the study treatment","Participants with HNC","Positive pregnancy serum or urine beta-human chorionic gonadotropin (beta-hCG) test","Participants with mCRPC","Use of other medications for urinary symptoms including 5-alpha reductase inhibitors (finasteride and dutasteride) and alternative medications known to alter PSA (e.g., phytoestrogens and saw palmetto) within 1 week prior to the study treatment initiation"],"whatHappens":"If you join, the listed intervention(s) are SX-682, or DTX. The registry lists allocation as randomized. Background: Head and neck cancers (HNCs) account for about 5% of all cancers worldwide.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at Bethesda. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.304Z"},{"nctId":"NCT07667621","title":"A Prospective, Open-Label Study Evaluating the Effectiveness of Gepants for Acute Treatment of Migraine in the Emergency Department","officialTitle":"A Prospective, Open-Label Study Evaluating the Effectiveness of Rimegepant ODT or Zavegepant Nasal Spray for Acute Treatment of Migraine in the Emergency Department","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of South Florida","sponsorClass":"OTHER","summary":"Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days. Participants will be allocated to either the rimegepant trial or the zavegepant trial. The study design does not include a placebo or active comparator control group, and the two gepant study drugs are not designed to function as active comparator groups. The objective in this investigation is to examine relief from either rimegepant or zavegepant in separate parallel trials.","conditions":["Migraine","Migraine Disease","Migraine in Adults","Migraine Headache","Acute Migraine","Migraine Without Aura","Migraine With Aura"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rimegepant"},{"type":"DRUG","name":"Zavegepant"}],"enrollment":100,"startDate":"2026-09-15","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* • At least 18 years of age\n\n  * Capacity to provide informed consent (without a Representative)\n  * Emergency Department presentation for a headache consistent with migraine, based either on the treating clinical team's judgement, or fulfillment of International Classification of Headache Disorders (ICHD-3) criteria for migraine without aura or with typical aura, or for probable migraine without aura or with typical aura. It is acceptable if current headache duration is \\>72 hours. Must have been headache free for \\>48 hours prior to current attack.\n  * Willing to participate in post-discharge telephone assessments\n  * English and/or Spanish speaking patients\n\nExclusion Criteria:\n\n* • Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant.\n\n  * Use of analgesics or abortive headache medications within 60 minutes of study medication administration\n  * Use of the following drug/food categories with potential for drug interactions within 7 days or 5 half-lives, whichever is longer: 1) CYP3A strong or moderate inducers, 2) CYP3A4 strong inhibitors, 3) P-glycoprotein (P-gp) inhibitors, 4) OATP1B3 transporter potent inhibitors/inducers, 5) NTCP transporter potent inhibitors/inducers\n  * History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable\n  * History of any stroke within 3 months, or any lifetime stroke and age ≥65 years\n  * History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate\n  * History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)\n  * History of severe hepatic impairment, as assessed by the investigator or qualified delegate\n  * History of kidney disease stage 4 (eGFR \\<30 mL/min/1.73 m2)\n  * History of hypersensitivity reaction to rimegepant, zavegepant, or to any included inactive ingredients\n  * Lifetime use of CGRP-targeting acute or preventive migraine medications\n  * In custody of law enforcement\n  * Current pregnancy or lactation\n\n    * All individuals of childbearing potential must have a negative pregnancy test at screening (urine or serum).\n    * A person is considered to be of childbearing potential if possessing female reproductive organs at birth, post-menarchal, has not reached a post-menopausal state (≥12 continuous months of amenorrhea with no cause identified other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis).","locations":[{"facility":"Tampa General Hospital Emergency Room","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Pain relief at 2 hours without rescue medication"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["tampa-florida"],"enrichment":{"headline":"Phase 1: testing Rimegepant for Migraine","inPlainEnglish":"Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials. Participants will receive rimegepant or zavegepant for acute migraine treatment during a single Emergency Department visit, with post-discharge follow-up through 28 days.","whoItsFor":["Ages 18 Years to any","At least 18 years of age","English and/or Spanish speaking patients"],"whoShouldSkip":["Use of intranasal decongestants within 1 hour prior to study drug administration, due to the potential to decrease absorption of intranasal zavegepant","Use of analgesics or abortive headache medications within 60 minutes of study medication administration","History of ischemic cardiovascular disease, diabetes, or hypertension (diagnosed or likely based on multiple readings), that was recently diagnosed within 3 months of screening or is currently uncontrolled or unstable","History of any stroke within 3 months, or any lifetime stroke and age ≥65 years","History of significant peripheral vascular disease, as assessed by the investigator or qualified delegate","History of Raynaud's Phenomenon (medically diagnosed, or non-medically diagnosed with affirmative responses to both unusual sensitivity and finger color change with cold exposure)","History of severe hepatic impairment, as assessed by the investigator or qualified delegate"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant, or Zavegepant. The registry lists allocation as randomized. Prospective, single-site, open-label, non-controlled pilot study consisting of two parallel trials.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 100 people at Tampa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.298Z"},{"nctId":"NCT07668388","title":"A Research Study Comparing How Well Different Doses of the Medicine UBT251 Lower Blood Sugar in People With Type 2 Diabetes","officialTitle":"Efficacy and Safety of Once-weekly Subcutaneous UBT251 in Participants With Type 2 Diabetes - a Dose-finding Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes. Participants will either get UBT251, UBT251 placebo, semaglutide, or semaglutide placebo. Which treatment participants get is decided by chance. UBT251 is the treatment being tested and is not yet available for doctors to prescribe, while semaglutide is a medicine used to treat type 2 diabetes that doctors can already prescribe.","conditions":["Diabetes Mellitus, Type 2"],"keywords":[],"interventions":[{"type":"DRUG","name":"UBT251"},{"type":"DRUG","name":"UBT251 Placebo"},{"type":"DRUG","name":"Semaglutide"},{"type":"DRUG","name":"Semaglutide Placebo"}],"enrollment":300,"startDate":"2026-06-22","completionDate":"2027-10-04","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18-75 years (both inclusive) at the time of signing the informed consent.\n* Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening.\n* Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:\n\nmetformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor.\n\n* HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening.\n* Body mass index between 25.0 kg/m\\^2 and 50.0 kg/m\\^2 (both inclusive) at screening.\n\nExclusion Criteria:\n\n* Treatment with any medication (prescription or over-the counter) or alternative remedies for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.\n* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8.","locations":[{"facility":"Flourish Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Institute for Metabolic Research","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Catalina Research Institute, LLC","city":"Montclair","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research LLC","city":"Hollywood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"South Broward Research LLC","city":"Miramar","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research of Weston","city":"Weston","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Inst For Clin Res","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cotton O'Neil Diabetes & Endocrinology","city":"Topeka","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Medical Research","city":"Oxon Hill","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PharmQuest","city":"Greensboro","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"KDCILM, LLC & Accellacare US, Inc.","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Plains Clinical Research Center, LLC_Fargo","city":"Fargo","state":"North Dakota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Preferred Primary Care Physicians, Inc.","city":"Uniontown","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research, LLC","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LifeDoc Health","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Private Practice - Dr. Laila A. Hassan","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Radiance Clinical Research","city":"Lampasas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Quality Research Inc","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tekton Research Inc","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consano Clin Res-Shavano Park","city":"Shavano Park","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chrysalis Clinical Research","city":"St. George","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Vancouver Clinic","city":"Vancouver","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Castle Hill Medical Centre","city":"Castle Hill","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novatrials","city":"Charlestown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hunter Medical Research Institute - Endocrinology and Diabetes","city":"New Lambton Heights","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Roger Chih Yu Chen","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Adelaide Hospital - Cardiology Department","city":"Adelaide","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Baker Heart and Diabetes Institute","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Versdias - Diabetologikum Amberg","city":"Amberg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Herz- und Diabeteszentrum NRW - Bad Oeynhausen","city":"Bad Oeynhausen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"DSP Bochum, Diabetes- und Stoffwechselpraxis","city":"Bochum","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Studiengesellschaft Dres. Könemann/Steinmann GbR","city":"Bünde","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"InnoDiab Forschung GmbH","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mesut Durmaz, Hof","city":"Hof","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"CRS Clinical Research Services Mannheim GmbH (hVIVO Mannheim)","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ","city":"Szeged","state":"Csongrád-Csanád","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Szent Margit Rendelőintézet Nonprofit Kft.","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Semmelweis Egyetem","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"PVN Kutató Kft.","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pécsi Tudományegyetem ÁOK","city":"Pécs","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"1 Wojskowy Szpital Kliniczny z Poliklinika SPZOZ","city":"Lublin","state":"Lublin Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"NZOZ Vita-Diabetica Malgorzata Buraczyk","city":"Bialystok","state":"Podlaskie Voivodeship","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny w Bialymstoku","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otyłości lek. Monika Piwowar","city":"Kielce","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Best Solutions Sp. z o.o., Sp. k","city":"Lublin","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Formed 2 Sp. z o.o.","city":"Oświęcim","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"S.C. Top Diabet Srl","city":"Craiova","state":"Dolj","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mariodiab Clinic SRL","city":"Brasov","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"SC Nutrilife SRL","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"S.C Milena Sante SRL","city":"Galati","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinica Korall S.R.L. Satu Mare","city":"Satu Mare","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara","city":"Timișoara","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"MEDISPEKTRUM s.r.o.","city":"Bratislava","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"IN-DIA s.r.o.","city":"Lučenec","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"MEDI-DIA s.r.o.","city":"Sabinov","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"ARETEUS s.r.o.","city":"Trebišov","state":"","country":"Slovakia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chosun University Hospital_Endocrinology","city":"Gwangju","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center_Endocrinology","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, Seoul ST. Mary's Hospital_Endocrinology","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital_Endocrinology","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Equip D'assistencia Primaria Vic S.L.P.","city":"Vic","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eap Osona Sud Alt Congost S.L.P","city":"Centelles (Barcelona)","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de la Princesa","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. Univ. Marqués de Valdecilla_Endocrinología","city":"Santander","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"H. Infanta Luisa_Endocrino y Obesidad","city":"Seville","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["UBT251: Change in glycated haemoglobin (HbA1c)"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":["semaglutide"],"locationSlugs":["birmingham-alabama","fountain-valley-california","long-beach-california","los-angeles-california","montclair-california","hollywood-florida","miramar-florida","weston-florida","indianapolis-indiana","topeka-kansas","oxon-hill-maryland","greensboro-north-carolina","wilmington-north-carolina","fargo-north-dakota","uniontown-pennsylvania","north-charleston-south-carolina","memphis-tennessee","austin-texas","houston-texas","lampasas-texas","san-antonio-texas","shavano-park-texas","st-george-utah","vancouver-washington","castle-hill-australia","charlestown-australia","new-lambton-heights-australia","sydney-australia","adelaide-australia","melbourne-australia","amberg-germany","bad-oeynhausen-germany","berlin-germany","bochum-germany","b-nde-germany","essen-germany","hof-germany","mannheim-germany","szeged-hungary","budapest-hungary","p-cs-hungary","lublin-poland","bialystok-poland","kielce-poland","o-wi-cim-poland","craiova-romania","brasov-romania","bucharest-romania","galati-romania","satu-mare-romania","timi-oara-romania","bratislava-slovakia","lu-enec-slovakia","sabinov-slovakia","trebi-ov-slovakia","gwangju-south-korea","seoul-south-korea","vic-spain","barcelona-spain","centelles-barcelona-spain","madrid-spain","santander-spain","seville-spain"],"enrichment":{"headline":"Phase 2: testing UBT251 for Diabetes Mellitus, Type 2","inPlainEnglish":"The study is testing UBT251 in participants with type 2 diabetes. The purpose of this clinical study is to find out if UBT251 is effective and safe for treating participants with type 2 diabetes.","whoItsFor":["Ages 18 Years to 75 Years","Male or female (sex assigned at birth, inclusive of all gender identities)","Diagnosed with type 2 diabetes greater than or equal to (≥) 180 days before screening","Stable daily dose(s) ≥ 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:","metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitor","HbA1c of 7.0-10.5 percent (%) (53-91 millimoles per mole (mmol/mol)) (both inclusive) as assessed by central laboratory at screening","Body mass index between 25.0 kg/m\\^2 and 50.0 kg/m\\^2 (both inclusive) at screening"],"whoShouldSkip":["Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire, question 8"],"whatHappens":"If you join, the listed intervention(s) are UBT251, UBT251 Placebo, or Semaglutide. The registry lists allocation as randomized. The study is testing UBT251 in participants with type 2 diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 300 people at 70 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.737Z"},{"nctId":"NCT07669935","title":"Advancing Stillbirth Prevention Through Innovative Risk Evaluation (ASPIRE) Clinical Study","officialTitle":"A Multi-Site, Prospective, Two-Part Longitudinal, Observational Cohort Study Of Pregnant Women To Evaluate Biomarkers For Prediction Of Pregnancy Complications","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Medicines360","sponsorClass":"OTHER","summary":"ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional observational cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \\[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\\] and risk of adverse outcomes.","conditions":["GDM","Preterm Preeclampsia","Preeclampsia","Fetal Growth Restriction (FGR)","Pregnancy Complications"],"keywords":[],"interventions":[{"type":"OTHER","name":"None (this is an observational study with no intervention)"}],"enrollment":5500,"startDate":"2026-09-08","completionDate":"2028-07-01","sex":"FEMALE","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Nulliparous (no previous births ≥20wk GA)\n* Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation\n* Ability to consent and comply with study procedures and follow-up\n\nExclusion Criteria:\n\n* Multiple gestation\n* Inability to provide blood\n* Known fetal chromosomal abnormalities or structural Anomaly (a structural or functional defect with the following three characteristics: 1) of prenatal origin; 2) present at the time of live birth or fetal demise, or in utero; 3) affecting (or has the propensity to affect) the health, survival, or physical or cognitive functioning of the individual\n* Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)\n* Current or recent (within two months) participation in an interventional clinical study.","locations":[{"facility":"Yale New Haven Health System","city":"Bridgeport","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale New Haven Health System","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Woman's Hospital","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Lawrence Health","city":"Potsdam","state":"New York","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"UTHealth Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carrie Fralick, MS","phone":"225-512-5546","email":"Carie.Fralick@womans.org"}],"primaryOutcomes":["Identification of cut-offs for risk stratification for conditions such as preeclampsia, fetal growth restriction and gestational diabetes at different timepoints in gestation.","To perform clinical validation of blood-based biomarkers using cut-offs at different timepoints in gestation.","To develop a retinal imaging algorithm for risk prediction for preeclampsia.","To validate the accuracy and test parameters of retinal imaging for risk prediction and management of pregnancies at risk for preeclampsia."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["bridgeport-connecticut","new-haven-connecticut","baton-rouge-louisiana","potsdam-new-york","houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: None (this is an observational study with no intervention) for GDM","inPlainEnglish":"ASPIRE will be a multi-site, prospective, two-part longitudinal, noninterventional watch-and-measure (no experimental treatment required) cohort study of nulliparous singleton pregnant women to evaluate biomarkers from blood and ocular imaging for prediction of pregnancy complications \\[i.e., preeclampsia (PE), fetal growth restriction (FGR), and gestational diabetes (GDM)\\] and risk of adverse outcomes.","whoItsFor":["Ages 18 Years to 99 Years","Women only","Nulliparous (no previous births ≥20wk GA)","Single viable fetus at the dating ultrasound scan with an ultrasound estimated gestational age of 10 0/7-17 6/7 weeks of gestation","Ability to consent and comply with study procedures and follow-up"],"whoShouldSkip":["Inability to provide blood","Known or anticipated inability to complete study follow-up through delivery at the study site (e.g., planned relocation, transfer of obstetric care to a non-participating institution, or other circumstances making delivery outcome data unavailable)","Current or recent (within two months) participation in an treatment clinical study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,500 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.035Z"},{"nctId":"NCT07670416","title":"A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes","officialTitle":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 in Adult Chinese Patients With Obesity or Overweight, With or Without Type 2 Diabetes Mellitus","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the efficacy and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.","conditions":["Obesity","Overweight","Type 2 Diabetes Mellitus (T2DM)"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Enicepatide"},{"type":"COMBINATION_PRODUCT","name":"Placebo"}],"enrollment":300,"startDate":"2026-07-03","completionDate":"2028-02-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Body mass index (BMI) ≥24.0 kilograms per meter squared (kg/m\\^2) for participants with type 2 diabetes mellitus (T2DM)\n* BMI ≥28.0 kg/m\\^2 or BMI ≥24.0 and \\<28.0 kg/m\\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM\n* Agreement to adhere to the contraception requirements\n\nExclusion Criteria:\n\n* History of Type 1 diabetes mellitus (T1DM)\n* Obesity induced by other endocrinologic disorders\n* Any planned major medical procedure or surgery during the study\n* History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder\n* Any lifetime history of suicide attempt\n* History of any hematologic conditions that may interfere with HbA1c measurement\n* History of acute or chronic pancreatitis or clinically significant gallbladder disease\n* Treatment with any approved or investigational GLP-1-RA-based therapy within 6 months prior to randomization\n* Treatment with other investigational therapy within 3 months prior to randomization or less than 5 elimination half-lives prior to randomization, whichever is longer\n* Known allergy to any component of the study drug formulation or any other condition that is a contraindication to GLP-1 RAs or GLP-1/GIP RAs","locations":[{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yan'an University Xianyang Hospital","city":"Xianyang","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Ningbo University(Ningbo First Hospital)","city":"Ningbo","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Jilin University","city":"Changchun","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Affiliated Hospital of Harbin Medical University","city":"Herbin","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huai'an First People's Hospital","city":"Huai'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huzhou Central Hospital","city":"Huzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hebei Petro China Central Hospital","city":"Langfang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Luoyang Third People's Hospital","city":"Luoyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Jiangning Hospital of Nanjing Medical University","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Tenth People's Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tongren Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Fifth People's Hospital Affiliated to Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The People's Hospital of Liaoning Province","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shenyang Fifth People Hospital","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hebei Medical University - The Second Hospital","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zibo Municipal Hospital.","city":"Zibo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: YC46401 https://forpatients.roche.com No attachments to email below.","phone":"888-662-6728 (U.S. Only)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percent Change From Baseline in Body Weight at Week 52"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["zhengzhou-china","xianyang-china","ningbo-china","beijing-china","changchun-china","hefei-china","herbin-china","huaian-china","huzhou-china","jinan-china","langfang-china","luoyang-china","nanjing-china","shanghai-china","shenyang-china","shijiazhuang-china","zibo-china"],"enrichment":{"headline":"Phase 3: Enicepatide for Obesity","inPlainEnglish":"This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.","whoItsFor":["Ages 18 Years to any","Body mass index (body-mass index (BMI)) ≥24.0 kilograms per meter squared (kg/m\\^2) for participants with type 2 diabetes mellitus (T2DM)","body-mass index (BMI) ≥28.0 kg/m\\^2 or body-mass index (BMI) ≥24.0 and \\<28.0 kg/m\\^2 and diagnosed with at least one weight-related comorbidity (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea, or weight-related cardiovascular disease) for participants without T2DM","Agreement to adhere to the contraception requirements"],"whoShouldSkip":["History of Type 1 diabetes mellitus (T1DM)","Obesity induced by other endocrinologic disorders","Any planned major medical procedure or surgery during the study","History of significant active or unstable major depressive disorder (major depression) or other severe psychiatric disorder","Any lifetime history of suicide attempt","History of any hematologic conditions that may interfere with HbA1c measurement","History of acute or chronic pancreatitis or clinically significant gallbladder disease"],"whatHappens":"If you join, the listed intervention(s) are Enicepatide, or Placebo. The registry lists allocation as randomized. This study wants to assess the how well it works and safety of enicepatide, a dual glucagon-like peptide-1 (GLP-1)/glucose-dependent insulinotropic polypeptide (GIP) receptor agonist (RA) being developed for chronic weight management, as an adjunct to a reduced-calorie diet and increased physical activity in participants without Type 2 diabetes mellitus (T2DM) who have obesity or overweight with at least one weight-related comorbidity, and in participants with T2DM who have obesity or overweight.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 21 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.527Z"},{"nctId":"NCT07671677","title":"BOdygUardian MOnitoriNg for ReCurrencE of AF","officialTitle":"BOdygUardian MOnitoriNg for ReCurrencE of AF (BOUNCE-AF)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Heart Rhythm Clinical and Research Solutions, LLC","sponsorClass":"OTHER","summary":"The DISRUPT-AF Registry is an observational, prospective, multi-center, non-randomized, real-world registry designed to obtain clinical experience with the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation (AF). The data collected for this study will be from a subset of patients enrolled in the pre-existing DISRUPT AF Registry. Additionally, patients in the Full Monitoring Arm may be approached and consented for participation in BOUNCE-AF. The post-ablation monitoring timepoints will reflect the site's standard of care (SOC), which is typically at 6- and 12-months post-ablation. Consented patients will complete 1 survey about their experience after wearing the BodyGuardian at 6-months. Clinical staff that consent will also complete a survey on their experience using BodyGuardian. The clinical staff include those that either directly prescribe the monitor, place the monitor on the patient and/or train the patient on the use of the monitor, or those involved in reviewing the data.","conditions":["Atrial Fibrillation (AF)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"BodyGuardian"}],"enrollment":100,"startDate":"2026-08-13","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:\n\n1. Eligible for and willing to consent for participation in DISRUPT-AF\n2. Willing to consent to the sub-study\n3. Willing to complete the post-ablation BodyGuardian wearable monitoring\n4. Willing to complete the BOUNCE AF survey\n\nClinical staff willing to consent to complete surveys must meet one of the following requirements:\n\n1. Prescribe the monitor by enrolling patients into the BodyGuardian platform.\n2. Review monitor data using the BodyGuardian platform.\n\nExclusion Criteria:\n\n1\\. Known allergy to adhesives that would contraindicate wearing BodyGuardian","locations":[{"facility":"Arrhythmia Center of South Florida","city":"Delray Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HCA Research Institute (FL Mercy Miami)","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Iowa Hospitals and Clinics","city":"Iowa City","state":"Iowa","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Allegheny General Hospital","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St. Mark's Hospital","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kayla Oliver","phone":"763-381-7972","email":"koliver@hrcrs.com"},{"name":"Megan Goodfellow","phone":"563-599-4146","email":"mgoodfellow@hrcrs.com"}],"primaryOutcomes":["Primary Objectives"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["delray-beach-florida","miami-florida","iowa-city-iowa","pittsburgh-pennsylvania","salt-lake-city-utah"],"enrichment":{"headline":"Not a traditional drug phase: BodyGuardian for Atrial Fibrillation (AF)","inPlainEnglish":"The DISRUPT-AF Registry is an watch-and-measure (no experimental treatment required), prospective, multi-center, non-randomly assigned, real-world registry designed to obtain clinical experience with the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of atrial fibrillation (AF). The data collected for this study will be from a subset of patients enrolled in the pre-existing DISRUPT AF Registry.","whoItsFor":["Ages 18 Years to any","Patients must meet all the following criteria to be eligible for inclusion in the BOUNCE-AF sub-study:","Eligible for and willing to consent for participation in DISRUPT-AF","Willing to consent to the sub-study","Willing to complete the post-ablation BodyGuardian wearable monitoring","Willing to complete the BOUNCE AF survey","Clinical staff willing to consent to complete surveys must meet one of the following requirements:","Prescribe the monitor by enrolling patients into the BodyGuardian platform"],"whoShouldSkip":["1\\. Known allergy to adhesives that would contraindicate wearing BodyGuardian"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 5 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.748Z"},{"nctId":"NCT07671937","title":"INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study","officialTitle":"INtegrating Systematic PatIent-Reported Evaluations in Multi-Disciplinary Tumor Boards: The INSPIRE Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Alabama at Birmingham","sponsorClass":"OTHER","summary":"The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, evaluate the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.","conditions":["Breast Cancer","Corpus Uteri Cancer","Ovary Cancer","Pancreas Cancer","Other Female Genital Malignant Neoplasms"],"keywords":["PROs","Multidiscipinary tumor board","INSPIRE intervention","Pancreatic Cancer","Breast Cancer","gynecologic cancers"],"interventions":[{"type":"BEHAVIORAL","name":"INSPIRE (INtegrating Systematic PatIent-Reported Evaluations)"},{"type":"BEHAVIORAL","name":"Capture of patient-reported outcomes"},{"type":"BEHAVIORAL","name":"Enhanced Clinician Awareness"}],"enrollment":2748,"startDate":"2026-10-02","completionDate":"2030-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion/Exclusion Criteria: We will include two populations: (1) patients and (2) clinical team members involved in the MDTB.\n\nInclusion Criteria:\n\n* Inclusions Criteria- Patients:\n\n  1. aged 18 years or older;\n  2. with suspected or confirmed diagnosis of pancreatic, breast, and gynecologic cancer (all stages) within 8 weeks of diagnosis. This may include diagnosis of a new recurrence. Patients may have had some treatment prior to being seen at a participating institution as long as they are within the 8-week timeframe. Patients may be diagnosed at a participating institution or outside. If there is diagnostic uncertainty and/or patient has not received treatment they will be allowed to participate if they are beyond the 8 weeks of diagnosis.\n  3. intention to be treated at a participating institution;\n  4. with verbal fluency in English or Spanish; and\n  5. scheduled to be discussed at MDTB.\n* Inclusion criteria - Clinicians:\n\nAll clinical team members participating in the pancreatic, breast, or gynecologic MDTB at a participating site will be included and have pre-emptively agreed to participation.\n\nExclusion Criteria:\n\n* Exclusion criteria - Patients:\n\nIndividuals with plans to receive cancer treatment outside the participating institution and inability to speak English or Spanish.\n\n* Exclusion criteria - Clinician:\n\nClinicians will retain the opportunity to opt-out of participation, in which case their portions of the discussion will not be included in the analysis; however, this is not anticipated based on pilot data.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of California Los Angeles (UCLA)","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma (OU) Health Campus","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gabrielle B Rocque, MD","phone":"(205) 975-2914","email":"grocque@uabmc.edu"},{"name":"Margaret A Thomas, MPH","phone":"2058421632","email":"margaretathomas@uabmc.edu"}],"primaryOutcomes":["Treatment modifications"],"hasResults":false,"conditionSlugs":["breast-cancer","pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","los-angeles-california","oklahoma-city-oklahoma"],"enrichment":{"headline":"Not a traditional drug phase: INSPIRE (INtegrating Systematic PatIent-Reported Evaluations) for Breast Cancer","inPlainEnglish":"The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, measure the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.","whoItsFor":["Ages 18 Years to any"],"whoShouldSkip":["We will include two populations: (1) patients and (2) clinical team members involved in the MDTB","who can join:","Inclusions Criteria- Patients:","aged 18 years or older;","intention to be treated at a participating institution;","with verbal fluency in English or Spanish; and","scheduled to be discussed at MDTB"],"whatHappens":"If you join, the listed intervention(s) are INSPIRE (INtegrating Systematic PatIent-Reported Evaluations), Capture of patient-reported outcomes, or Enhanced Clinician Awareness. The registry lists allocation as randomized. The purpose of the study is to characterize baseline multidisciplinary tumor board (MDTB) context and variability, measure the relationship between baseline fitness of patients with cancer and initial treatment recommendations, and assess the impact of the INSPIRE intervention, which involves including electronic patient reported outcomes (ePROs) within MDTB on MDTB discussion content, provider burden, treatment recommended and received, healthcare utilization, and patient-reported outcomes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 2,748 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.458Z"},{"nctId":"NCT07673887","title":"A Study of ASP2138 Together With Chemotherapy and Pembrolizumab in Adults With Gastric Cancer","officialTitle":"A Phase 3, Global, Multi-center, Double-blind, Randomized Study of ASP2138 Plus Chemotherapy (CAPOX or mFOLFOX6) With Pembrolizumab vs Placebo Plus Chemotherapy With or Without Pembrolizumab in First-line Treatment of Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma in Participants Whose Tumors Are HER2-negative and Claudin (CLDN) 18.2-positive","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Astellas Pharma Global Development, Inc.","sponsorClass":"INDUSTRY","summary":"Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. It is also found in some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors. ASP2138 is thought to bind to CLDN18.2 and a type of immune cell called a T cell. This \"tells\" the immune system to attack the tumor. ASP2138 is a potential treatment for people with gastric cancer (also known as stomach cancer) or gastroesophageal junction cancer (GEJ cancer). GEJ is where the tube that carries food (esophagus) joins the stomach.\n\nThis study is for people with gastric or GEJ cancer that has spread nearby (locally advanced) and is not removable by surgery (unresectable), or has spread to other parts of the body (metastatic). It is for those whose cancer is human epidermal growth factor receptor 2 (HER2)-negative and CLDN18.2-positive. HER2-negative means the cancer does not have extra HER2 protein, so medicines that target HER2 do not work and are therefore not used. CLDN18.2-positive means people have a certain amount of CLDN18.2 proteins on their cancer cells. In this study, researchers want to learn if ASP2138 given together with standard treatments (chemotherapy and pembrolizumab) help people with HER2-negative and CLDN18.2-positive gastric or GEJ cancer. The main aim is to learn how long people who are given ASP2138 with chemotherapy and pembrolizumab live without their cancer getting worse, compared with placebo given with chemotherapy with or without pembrolizumab, and if they live for longer. Placebo looks like the study treatment but does not have any medicine in it.\n\nThe main aim of this study is to check how well ASP2138 works when given together with chemotherapy and pembrolizumab compared with placebo plus chemotherapy with or without pembrolizumab.\n\nPeople aged 18 years or older with locally advanced unresectable or metastatic gastric or GEJ cancer can take part. Their tumor should be HER2-negative and CLDN18.2-positive. The study doctors will check people for any health conditions that can exclude them from taking part, interfere with the study procedures, or pose an unacceptable risk.\n\nThis is a double-blind study. That means the people and the study doctors will not know who will receive which treatment. People will be assigned to one of 2 treatment groups by chance:\n\nGroup A: People will receive ASP2138 along with chemotherapy and pembrolizumab. Group B: People will receive placebo along with chemotherapy, with or without pembrolizumab.\n\nPeople will keep receiving treatment until their cancer gets worse, they have medical problems that require stopping treatment, or a study rule says they must stop. There will be regular safety checks. People will continue to have scans of their tumor until their cancer becomes worse.","conditions":["Gastric Adenocarcinoma","Gastroesophageal Junction (GEJ) Adenocarcinoma"],"keywords":["Claudin (CLDN) 18.2","ASP2138","Advanced Unresectable or Metastatic Gastric Adenocarcinoma","Advanced Unresectable or Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma"],"interventions":[{"type":"DRUG","name":"ASP2138"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Oxaliplatin"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Folinic acid"},{"type":"DRUG","name":"5-FU"},{"type":"DRUG","name":"Placebo for ASP2138"},{"type":"DRUG","name":"Placebo for Pembrolizumab"}],"enrollment":570,"startDate":"2026-07-28","completionDate":"2031-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma.\n* Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization.\n* Participant has predicted life expectancy \\>= 12 weeks.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a women of childbearing potential (WOCBP)\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum human chorionic gonadotropin (HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after the final administration of study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after the final administration of study intervention.\n* Male participant must not donate sperm during the treatment period and for 6 months after the final administration of study intervention.\n* Participant has radiologically evaluable disease (measurable and/or non measurable) according to RECIST V1.1, per investigator assessment, \\<= 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy \\<= 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy.\n* Participant's tumor is HER2-negative (HER2 immunohistochemistry (IHC) score 0+/1+ or HER2 IHC score 2+/in situ hybridization (ISH) negative) as determined by local or central testing.\n* Participant has provided an formalin-fixed paraffin-embedded (FFPE) tumor sample which meets the requirements of the study as specified in the laboratory manual.\n* Participant has CLDN18.2-positive tumor as determined by central testing.\n* Participant has a valid programmed death-ligand 1 (PD-L1) result as determined by central testing of a tumor sample.\n* Participant with known microsatellite instability-high or mismatch repair deficient status may enroll as long as their tumor expresses PD-L1 combined positive score (CPS) \\>= 1 as determined by central IHC testing.\n* Participant has ECOG performance status 0 to 1.\n* Participant must meet all of the criteria based on the centrally or locally analyzed laboratory tests collected within 14 days prior to randomization. In case of multiple central laboratory data within this period, the most recent data should be used (transfusion is allowed, but posttransfusion hemoglobin \\[24 hours or later following transfusion\\] must be \\>= 9 g/dL).\n\nSouth Korea Specific:\n\n* Participant is \\>= 19 years of age at the time of signing informed consent.\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening and agrees to follow the contraceptive guidance from the time of informed consent through at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG) and a demonstrated nonpregnant status through additional testing are eligible.)\n* Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for at least 15 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period, and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n* Male participant must not donate sperm during the treatment period and for 12 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention.\n\nJapan Specific:\n\n* Female participant is not pregnant and at least 1 of the following conditions apply:\n\n  * Not a WOCBP\n  * WOCBP who has a negative serum pregnancy test at screening with a medical interview and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention. (Note: For screening, participants with elevated serum HCG and a demonstrated nonpregnant status through additional testing are eligible.)\n\nExclusion Criteria:\n\n* Participant has mixed histology or non-adenocarcinoma gastric or GEJ cancer.\n* Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (i.e., without evidence of progression) for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to randomization.\n* Participant has gastrointestinal (GI) perforation, fistulae, untreated gastric ulcers that would preclude the participant from study participation, or any arterial thromboembolic event within 6 months, or any significant GI bleeding or any significant venous thromboembolism within 3 months prior to randomization.\n* Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.\n* Participant has pre existing peripheral neuropathy \\> Grade 1.\n* Participant has poorly controlled hypertension.\n* Participant has significant cardiovascular disease, including any of the following:\n\n  * Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization.\n  * corrected QT (QTc) interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants.\n  * Documented history or family history of congenital long QT syndrome.\n  * Cardiac arrhythmias requiring anti-arrhythmic medications (Exception: Participant with rate-controlled atrial fibrillation for \\> 1 month prior to randomization is eligible), obligate use of cardiac pacemaker, or a history of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes).\n* Participant has a diagnosis of immunodeficiency or has been diagnosed with an autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Participants that require replacement therapy (e.g., thyroxine (T4), insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) may be enrolled.\n* Participant has psychiatric illness or social situations that would preclude study compliance.\n* Participant has history of another malignancy within 3 years prior to randomization, or any evidence of residual disease from a previously diagnosed malignancy. Participants with nonmelanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed.\n* Participant has history of (non-infectious) pneumonitis that required steroids, current pneumonitis, or has a history of interstitial lung disease.\n* Participant has known, existing uncontrolled coagulopathy. Concomitant treatment with medications that affect the coagulation cascade with an international normalized ratio (INR) \\> 2 (e.g., vitamin K antagonists) is not allowed.\n* Participant may receive low molecular weight heparin (LMWH) (such as enoxaparin and dalteparin) and direct oral anticoagulant (DOAC) for management of deep venous thrombosis (DVT).\n* Participant has a history of bleeding diathesis or recent major bleeding events (i.e. Grade \\>= 2 bleeding events 28 days prior to randomization).\n* Participant has uncontrolled intercurrent illness.\n* Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to randomization.\n* Participant is known to have human immunodeficiency virus (HIV) infection except for those with cluster of differentiation (CD) 4+ T cell counts \\>= 350 cells/microliter (µL) and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 12 months are eligible. NOTE: Screening for HIV infection should be conducted if indicated per local requirements.\n* Participant is known to have active hepatitis B (positive hepatitis B surface antigen \\[HBsAg\\]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. NOTE: Screening for these infections should be conducted if indicated per local requirements.\n\n  * For participant who is negative for HBsAg, but hepatitis B core (HBc) antibody positive, an hepatitis B virus (HBV) DNA test will be performed and if positive the participant will be excluded.\n  * Participant with positive hepatitis C virus (HCV) serology, but negative HCV RNA test results is eligible.\n  * Participant treated for HCV with undetectable viral load results is eligible.\n* Participant has a known history of a positive test for tuberculosis or known active tuberculosis infection. NOTE: Screening for these infections should be conducted per local requirements.\n* Participant has known complete dihydropyrimidine dehydrogenase (DPD) deficiency (screening for DPD deficiency should be conducted per local requirements).\n* Participant has pernicious anemia or other anemias due to vitamin B12 deficiency.\n* Participant has received prior systemic chemotherapy and/or immunotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. However, a maximum of 1 cycle of mFOLFOX6 or CAPOX with or without immunotherapy (for those participants with CPS \\>= 1) is allowed to be administered prior to randomization (Note: No dose modifications are allowed for the lead-in treatment). Participants may have received either neoadjuvant or adjuvant chemotherapy, immunotherapy, or other systemic anticancer therapies as long as they were completed at least 6 months prior to randomization and there was disease progression occurs at least 6 months after the last dose. Participant may have received treatment with herbal medications that have known antitumor activity \\> 28 days prior to randomization. NOTE: Participants must have recovered from all AEs due to previous therapies to \\<= Grade 1 or baseline.\n* Participant has received systemic immunosuppressive therapy, including systemic corticosteroids \\<= 7 days prior to randomization. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 10 mg per day of prednisone or equivalent), receiving a single dose of systemic corticosteroids or receiving systemic corticosteroids as premedication for radiologic imaging contrast use are allowed.\n* Participant has had a major surgical procedure \\<= 28 days before randomization and has not fully recovered.\n* Participant has received a CLDN18.2-targeted therapy \\<= 28 days or 5 half-lives (whichever is longer) prior to randomization, or participant has experienced Grade \\>= 3 GI toxicity after receiving a CLDN18.2-targeted therapy.\n* Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma \\<= 14 days prior to randomization and has NOT recovered from any related toxicity. A 7-day washout is permitted for palliative radiation (\\<= 14 days duration time for radiotherapy) to non-CNS disease.\n* Participant has received prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 \\[CTLA-4\\], OX-40, CD137) unless received in the perioperative setting.\n* Participant received a live or live-attenuated vaccine within 30 days prior to randomization. NOTE: Inactivated seasonal influenza vaccines are allowed.\n* Participant has received treatment with brivudine, sorivudine or their chemically related analogues within 28 days prior to randomization or within 5 half-lives of the drug, whichever is shorter.\n* Participant has received any investigational therapy within 28 days prior to randomization or within 5 half-lives of the investigational medicinal product (IMP), whichever is longer.\n* Participant has any condition including clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.\n* Participant has prior severe allergic reaction; suspected, known immediate or delayed hypersensitivity; or intolerance or contraindication to any study intervention.\n\nEU Specific:\n\n* Participant has known complete DPD deficiency (screening for DPD deficiency should be conducted per local requirements). All participants in the EU must be tested for DPD deficiency before receiving fluoropyrimidine-based chemotherapy, in accordance with European Society for Medical Oncology and European Medicines Agency (EMA) recommendations.","locations":[{"facility":"Metro Minnesota Community Oncology Research Consortium","city":"Saint Louis Park","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-Sen University Cancer Center - Huangpu Campus","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer","city":"Guangzhou","state":"Guangzhou","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa","state":"Chiba","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Shikoku Cancer Center","city":"Matsuyama","state":"Ehime","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Hokkaido Cancer Center","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hyogo Cancer Center","city":"Akashi","state":"Hyōgo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cancer Institute Hospital of JFCR","city":"Koto-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Niigata Cancer Center Hospital","city":"Niigata","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka International Cancer Institute","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pan American Center for Oncology Trials","city":"Dorado","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Astellas Pharma Global Development Inc","phone":"800-888-7704","email":"Astellas.registration@astellas.com"}],"primaryOutcomes":["Overall Survival (OS)","Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST V1.1) by Blinded Independent Central Review (BICR)"],"hasResults":false,"conditionSlugs":["stomach-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["saint-louis-park-minnesota","guangzhou-china","kashiwa-japan","matsuyama-japan","sapporo-japan","akashi-japan","chuo-ku-japan","koto-ku-japan","niigata-japan","osaka-japan","dorado-puerto-rico"],"enrichment":{"headline":"Phase 3: testing ASP2138 for Gastric Adenocarcinoma","inPlainEnglish":"Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system. Researchers are looking at ways to attack CLDN18.2 to help control tumors.","whoItsFor":["Ages 18 Years to any","Participant has histologically or cytologically confirmed gastric or GEJ adenocarcinoma","Participant has radiographically confirmed, locally advanced unresectable or metastatic disease within 28 days prior to randomization","Participant has predicted life expectancy \\>= 12 weeks","Female participant is not pregnant and at least 1 of the following conditions apply:","Not a women of childbearing potential (WOCBP)","Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period, and at least 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention","Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period, and for 9 months after the final oxaliplatin administration and 6 months after the final administration of all other study intervention"],"whoShouldSkip":["Participant has mixed histology or non-adenocarcinoma gastric or GEJ cancer","Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting","Participant has pre existing peripheral neuropathy \\> Grade 1","Participant has poorly controlled hypertension","Participant has significant cardiovascular disease, including any of the following:","Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization","corrected QT (QTc) interval \\> 450 msec for male participants; QTc interval \\> 470 msec for female participants"],"whatHappens":"If you join, the listed intervention(s) are ASP2138, Pembrolizumab, or Oxaliplatin. The registry lists allocation as randomized. Claudin 18.2 or CLDN18.2 is a protein found on cells in the digestive system.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 570 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.967Z"},{"nctId":"NCT07674277","title":"Virtual Reality for SCD VOC","officialTitle":"Randomized EvaLuation of ImmErsive Virtual Experiences in Sickle Cell Disease (RELIEVE-SCD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Maryland, Baltimore","sponsorClass":"OTHER","summary":"This randomized pilot study will evaluate the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality (VR) interventions for adults with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) treated in an infusion center. Up to 50 participants will be enrolled, provide informed consent, and undergo randomization during routine outpatient sickle cell clinic visits when they are clinically stable and not experiencing an acute VOC.\n\nUsing a randomized, two-period crossover design, each participant will be assigned to receive two of three headset-based interventions during separate qualifying infusion center visits for vaso-occlusive pain occurring within six months of enrollment: sham 2D headset control, passive immersive 3D VR, or active immersive interactive 3D VR. Each intervention will be delivered during a 45-minute session as an adjunct to usual clinical care.\n\nThe primary outcome is pain burden during the first 60 minutes after intervention start, measured as the area under the curve of 0-10 numeric rating scale pain scores. Secondary outcomes include feasibility of intervention delivery, headset tolerability, pain at 120 minutes, opioid consumption, and participant-reported immersion and acceptability. Findings will inform the design of future trials evaluating VR as an adjunctive treatment for acute vaso-occlusive pain.","conditions":["Sickle Cell Disease"],"keywords":["virtual reality (VR)","Sickle Cell Disease","vaso-occlusive crisis"],"interventions":[{"type":"DEVICE","name":"Sham 2D Headset Control"},{"type":"DEVICE","name":"Passive Immersive 3D Virtual Reality"},{"type":"DEVICE","name":"Active Immersive Interactive 3D Virtual Reality"}],"enrollment":50,"startDate":"2026-11-01","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"88 Years","healthyVolunteers":false,"eligibilityRaw":"Participants will be identified, screened, and consented during routine outpatient sickle cell disease clinic visits when they are clinically stable and not experiencing an acute vaso-occlusive crisis (VOC). Following enrollment, eligibility for each study intervention session will be confirmed during a qualifying VOC visit to the Stoler Infusion Center. Participants must meet the applicable clinical eligibility criteria and be receiving intravenous opioid treatment for acute vaso-occlusive pain at the time of the intervention visit.\n\n\\*\\*Inclusion Criteria:\\*\\*\n\n* Adult patients aged 18 years or older.\n* History of sickle cell disease.\n* Treatment plan by the clinical care team includes intravenous opioids for acute pain.\n* Receiving treatment through the Stoler Infusion Center.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Prior enrollment in this study.\n* Presentation with a chief complaint suggestive of a complicated vaso-occlusive crisis, including concern for acute chest syndrome, splenic sequestration, hepatic sequestration, or pulmonary embolism, as determined by the treating clinician.\n* Not receiving intravenous opioids for the vaso-occlusive crisis.\n* Inability to provide informed consent.\n* Medical history of seizures or known intolerance to virtual reality devices.\n* Preexisting visual or hearing impairments that, in the investigator's judgment, preclude use of a head-mounted virtual reality device.\n* Known pregnancy.\n* Incarceration at the time of evaluation.\n* Age greater than 88 years.","locations":[{"facility":"University of Maryland Medical Center, Stoler Infusion Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Soowon Lee, MSPH","phone":"254-400-4894","email":"Soowon.Lee@som.umaryland.edu"},{"name":"Rose Corcoran","phone":"2407439858","email":"rose.corcoran@som.umaryland.edu"}],"primaryOutcomes":["Pain burden during the first 60 minutes after intervention start"],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Sham 2D Headset Control for Sickle Cell Disease","inPlainEnglish":"This randomly assigned pilot study will measure the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality (VR) interventions for adults with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) treated in an infusion center. Up to 50 you would be enrolled, provide informed consent, and undergo randomization during routine outpatient sickle cell clinic visits when they are clinically stable and not experiencing an acute VOC.","whoItsFor":["Ages 18 Years to 88 Years","Adult patients aged 18 years or older","History of sickle cell disease","Treatment plan by the clinical care team includes intravenous opioids for acute pain","Receiving treatment through the Stoler Infusion Center"],"whoShouldSkip":["Prior enrollment in this study","Presentation with a chief complaint suggestive of a complicated vaso-occlusive crisis, including concern for acute chest syndrome, splenic sequestration, hepatic sequestration, or pulmonary embolism, as determined by the treating clinician","Not receiving intravenous opioids for the vaso-occlusive crisis","Medical history of seizures or known intolerance to virtual reality devices","Preexisting visual or hearing impairments that, in the investigator's judgment, preclude use of a head-mounted virtual reality device","Incarceration at the time of evaluation","Age greater than 88 years"],"whatHappens":"If you join, the listed intervention(s) are Sham 2D Headset Control, Passive Immersive 3D Virtual Reality, or Active Immersive Interactive 3D Virtual Reality. The registry lists allocation as randomized. This randomly assigned pilot study will measure the feasibility, tolerability, and preliminary analgesic effect of headset-based virtual reality (VR) interventions for adults with sickle cell disease (SCD) experiencing vaso-occlusive crisis (VOC) treated in an infusion center.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Baltimore. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.842Z"},{"nctId":"NCT07674654","title":"A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine","officialTitle":"A Long-Term Safety Study of Elismetrep (K-304) in the Acute Treatment of Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"TriGemX Bio, Inc.","sponsorClass":"INDUSTRY","summary":"This is a long-term safety study to evaluate the safety and tolerability of intermittent use of elismetrep in the acute treatment of migraine attacks.","conditions":["Acute Migraine"],"keywords":[],"interventions":[{"type":"DRUG","name":"Elismetrep"}],"enrollment":1000,"startDate":"2026-08-03","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participant completing an acute treatment trial of elismetrep (Study K-304 P003; attending the EoS Visit 3 within the allowed visit window of the acute treatment study), treated a qualifying migraine in that study, was at least 80% compliant with the daily e-Diary 'check-ins' in the base study and completed the 2-hour and 4-hour post-dose assessments in the eDiary.\n\n   Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was \\<80%;\n2. Participant voluntarily agrees to participate in the study by giving written informed consent;\n3. Participant is able to read, understand, and complete the study questionnaires and diary;\n4. Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;\n5. Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;\n6. For females of reproductive potential (as determined in the base study), continues to agree to remain abstinent from heterosexual activity or a. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the EoS visit.\n\nAcceptable methods of birth control are:\n\ni. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. ii. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral; injectable; implantable; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence\\*; progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; male or female condom with or without spermicide; cap, diaphragm or sponge with spermicide; a combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods).\n\n* Abstinence can be used as the sole method of contraception if it is in line with the participant's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.\n\nExclusion Criteria:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);\n2. Has, at the time of the base study EoS/Visit 3, had any change in medical history or a laboratory finding since screening in the acute treatment study that in the opinion of the investigator renders the participant unsuitable for this study (e.g., development of a finding that would have precluded participation in the base acute treatment study);\n3. Participant is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS) taken during the base study E0S/Visit 3, or of harm to others in the opinion of the investigator. Participants must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in 'since last version' version of the C-SSRS;\n4. Participant is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during trial participation) as assessed for the base study E0S/Visit 3;\n5. Has any major surgery scheduled for the duration of the trial;\n6. Has any other unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol, or otherwise interfere with the interpretation of efficacy and/or safety results;\n7. At Visit 1, has an open/ongoing adverse event from the base study EoS visit;\n8. Experienced a serious adverse event in the base study;\n9. Has previous participation in this trial. Participation is defined as signed informed consent following completion of the base study EoS/Visit 3 procedures.","locations":[{"facility":"Central Research Associates, LLC (CRA) dba Flourish Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Mobile","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TrialSphere","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Clinical Research","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Research, LLC","city":"Colton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"ProScience Research Group","city":"Culver City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Leading Edge Research LA, LLC","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Research, Orange County","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Downtown L.A. Research Center, Inc.","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research - Mission Mental Health (WR-MMH)","city":"Mission Viejo","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excell Research","city":"Oceanside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empire Clinical Research","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Neurology Group","city":"Pomona","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Acclaim Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Sherman Oaks CA (California Neuroscience Research)","city":"Sherman Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Encompass Clinical Research","city":"Spring Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunwise Clinical Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kinetic Clinical Research","city":"West Covina","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Focus Clinical Research","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMMUNOe Research Centers","city":"Centennial","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MCB Clinical Research Centers","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Neurosciences Research","city":"Fort Collins","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chase Medical Research, LLC","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Drug Studies America","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sleep Care Research Institute d/b/a Clinical Research Atlanta-Stockbridge","city":"Stockbridge","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Crosse Research Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Headache Center & Research Institute","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthcare Research Network II, LLC","city":"Flossmoor","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Headache Center & Research Institute","city":"Naperville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integrated Clinical Trials Solution","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collective Medical Research","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Associates Midwest, LLC","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Heartland Research Associates, LLC - An AMR Company","city":"Wichita","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Physicians to Children & Adolescents, PSC (Kentucky Pediatric / Adult Research)","city":"Bardstown","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CTI Clinical Research Center","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Crescent City Headache & Neurology Center","city":"Chalmette","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research - PharmaSite","city":"Pikesville","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Clinical Trials - Alcanza","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MedVadis Research Corporation, LLC","city":"Waltham","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Michigan Headache Pain & Neurological Institute","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DelRicht Research","city":"Gulfport","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Proven Endpoints","city":"Ridgeland","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Healthcare Research Network","city":"Hazelwood","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - 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Lewis Research, Inc. / Foothill Family Clinic Draper","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Granger Medical Clinic","city":"Riverton","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"J. Lewis Research, Inc. / Foothill Family Clinic","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Health Research of Hampton Roads, Inc. (HRHR)","city":"Newport News","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Norfolk","city":"Norfolk","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seattle Clinical Research Center","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Frontier Clinical Research","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Investigation Specialists, Inc.","city":"Kenosha","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Annemarie Vance","phone":"917-336-3654","email":"annemarie@kallyope.com"}],"primaryOutcomes":["Proportion of participants with at least one treatment-emergent adverse event (TEAE)","Proportion of participants with at least one treatment-emergent serious adverse event (SAE)","Proportion of participants with TEAEs leading to study drug discontinuation","Proportion of participants with TEAEs that occur in at least 5% of treated participants in either treatment arm"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","mobile-alabama","chandler-arizona","little-rock-arkansas","colton-california","culver-city-california","encino-california","irvine-california","los-angeles-california","mission-viejo-california","oceanside-california","pomona-california","riverside-california","san-diego-california","sherman-oaks-california","spring-valley-california","walnut-creek-california","west-covina-california","west-hills-california","centennial-colorado","colorado-springs-colorado","fort-collins-colorado","waterbury-connecticut","atlanta-georgia","marietta-georgia","stockbridge-georgia","chicago-illinois","flossmoor-illinois","naperville-illinois","west-des-moines-iowa","overland-park-kansas","wichita-kansas","bardstown-kentucky","lexington-kentucky","chalmette-louisiana","new-orleans-louisiana","pikesville-maryland","boston-massachusetts","waltham-massachusetts","ann-arbor-michigan","minneapolis-minnesota","gulfport-mississippi","ridgeland-mississippi","city-of-saint-peters-missouri","hazelwood-missouri","kansas-city-missouri","springfield-missouri","st-louis-missouri","las-vegas-nevada","north-las-vegas-nevada","reno-nevada","albuquerque-new-mexico","amherst-new-york","brooklyn-new-york","commack-new-york","manlius-new-york","new-york-new-york","rochester-new-york","williamsville-new-york","charlotte-north-carolina","greensboro-north-carolina","raleigh-north-carolina","shelby-north-carolina","columbus-ohio","milford-ohio","west-chester-ohio","edmond-oklahoma","oklahoma-city-oklahoma","tulsa-oklahoma","yukon-oklahoma","portland-oregon","allentown-pennsylvania","philadelphia-pennsylvania","pittsburgh-pennsylvania","scottdale-pennsylvania","smithfield-pennsylvania","north-charleston-south-carolina","chattanooga-tennessee","nashville-tennessee","austin-texas","cypress-texas","dallas-texas","houston-texas","lampasas-texas","plano-texas","waxahachie-texas","bountiful-utah","draper-utah","ogden-utah","riverton-utah","salt-lake-city-utah","newport-news-virginia","norfolk-virginia","seattle-washington","morgantown-west-virginia","kenosha-wisconsin"],"enrichment":{"headline":"Phase 3: testing Elismetrep for Acute Migraine","inPlainEnglish":"This is a long-term safety study to measure the whether it is safe and how hard side effects are to live with of intermittent use of elismetrep in the acute treatment of migraine attacks.","whoItsFor":["Ages 18 Years to any","Note: If a subject treats their qualifying migraine in the base study within 5 days of randomization (i.e. ≤ 4 daily check-ins should have been completed in the eDiary), they are eligible for this study if they missed 1 daily check-in, even though compliance was \\<80%;","Participant is able to read, understand, and complete the study questionnaires and diary;","Participant is willing and able to comply with the study schedule of visits, all trial procedures and restrictions;","Participant is willing to use his/her own personal, qualified smartphone to download any specific eDiary applications for use for the entire duration of the study;","Acceptable methods of birth control are:"],"whoShouldSkip":["Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Participants must have a negative urine pregnancy result at the base study EoS/Visit 3 (i.e., pre-randomization for this study);","Has any major surgery scheduled for the duration of the trial;","Has any other unwillingness or inability, not covered by any of the other"],"whatHappens":"If you join, the listed intervention(s) are Elismetrep. The registry lists allocation as randomized. This is a long-term safety study to measure the whether it is safe and how hard side effects are to live with of intermittent use of elismetrep in the acute treatment of migraine attacks.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 112 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.296Z"},{"nctId":"NCT07674667","title":"FUNCtion ALS: Aiming to Restore UNC13A Function in People Living With ALS","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Phase 1 / 2 Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Exploratory Efficacy of TRCN-1023 Administered by Intrathecal Injections to Adult People Living With Amyotrophic Lateral Sclerosis","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Trace Neuroscience, Inc.","sponsorClass":"INDUSTRY","summary":"The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomized, double-blind, placebo-controlled Phase 1/2 trial to evaluate the safety and tolerability of TRCN-1023 in adults living with ALS. TRCN-1023 is an investigational medicine given as a single injection into the fluid surrounding the spine (intrathecal injection). The trial will also assess how the body processes the drug and whether it shows early signs of benefit over 24 weeks.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"TRCN-1023"},{"type":"OTHER","name":"Placebo"}],"enrollment":30,"startDate":"2026-08-20","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Adults aged 18 to 75 years\n* Diagnosis of ALS (clinically definite, clinically probable, or clinically probable laboratory supported)\n* ALS symptoms began within the past 24 months\n* Able to perform breathing tests: slow vital capacity (SVC) with consistent results, with breathing capacity of at least 60% of the expected value\n* Able and willing to meet all study requirements, including travel to the study site, brain magnetic resonance imaging (MRI) scans, lumbar punctures, and blood draws\n* Able and willing to use wearable sensors and complete speech assessments at home\n* On a stable dose of approved ALS medication for at least 4 weeks prior to screening\n* Capable of providing informed consent\n\nKey Exclusion Criteria:\n\n* Carries a confirmed SOD1 or FUS gene mutation\n* Has a tracheostomy or requires continuous assisted ventilation more than 22 hours per day during the preceding 3 months before the first Screening Visit\n* Has a contraindication to brain MRI (e.g., pacemaker, metal implants)\n* Has a contraindication to lumbar puncture or spinal injection (e.g., blood clotting disorders, certain blood thinners, signs of increased pressure in the brain)\n* Has significant abnormal liver, kidney, or blood test results\n* Is currently enrolled in another clinical trial or has received an investigational treatment within the past 4 weeks\n* Has previously received gene therapy, stem cell therapy, or another Antisense oligonucleotide (ASO) treatment\n* Has a clinically significant condition other than ALS that could interfere with study participation","locations":[{"facility":"Universitätsklinikum Schleswig-Holstein","city":"Lübeck","state":"Schleswig-Holstein","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"TUM Klinikum Rechts der Isar","city":"Munich","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Rostock","city":"Rostock","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center Utrecht","city":"Utrecht","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"University College London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Sheffield","city":"Sheffield","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trace Neuroscience Clinical Trials","phone":"+1 415-390-9509","email":"Clinicaltrials@traceneuro.com"}],"primaryOutcomes":["Frequency of Adverse Events"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["l-beck-germany","munich-germany","rostock-germany","utrecht-netherlands","london-united-kingdom","sheffield-united-kingdom"],"enrichment":{"headline":"Phase 1 / Phase 2: testing TRCN-1023 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1/2 trial to measure the whether it is safe and how hard side effects are to live with of TRCN-1023 in adults living with ALS. TRCN-1023 is an investigational medicine given as a single injection into the fluid surrounding the spine (intrathecal injection).","whoItsFor":["Ages 18 Years to 75 Years","Adults aged 18 to 75 years","Diagnosis of ALS (clinically definite, clinically probable, or clinically probable laboratory supported)","ALS symptoms began within the past 24 months","Able to perform breathing tests: slow vital capacity (SVC) with consistent results, with breathing capacity of at least 60% of the expected value","Able and willing to meet all study requirements, including travel to the study site, brain magnetic resonance imaging (MRI) scans, lumbar punctures, and blood draws","Able and willing to use wearable sensors and complete speech assessments at home","On a stable dose of approved ALS medication for at least 4 weeks prior to screening"],"whoShouldSkip":["Carries a confirmed SOD1 or FUS gene mutation","Has a tracheostomy or requires continuous assisted ventilation more than 22 hours per day during the preceding 3 months before the first Screening Visit","Has a contraindication to brain MRI (e.g., pacemaker, metal implants)","Has a contraindication to lumbar puncture or spinal injection (e.g., blood clotting disorders, certain blood thinners, signs of increased pressure in the brain)","Has significant abnormal liver, kidney, or blood test results","Is currently enrolled in another clinical trial or has received an investigational treatment within the past 4 weeks","Has previously received gene therapy, stem cell therapy, or another Antisense oligonucleotide (ASO) treatment"],"whatHappens":"If you join, the listed intervention(s) are TRCN-1023, or Placebo. The registry lists allocation as randomized. The FUNCtion Amyotrophic Lateral Sclerosis (ALS) trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1/2 trial to measure the whether it is safe and how hard side effects are to live with of TRCN-1023 in adults living with ALS.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.608Z"},{"nctId":"NCT07677215","title":"ACB and iPACK Blocks With Intravenous Dexamethasone and Perineural Dexmedetomidine in Total Knee Arthroplasty","officialTitle":"Comparison of the Efficacy and Safety of Three Adjuvant Strategies for ACB and iPACK Blocks in Patients Undergoing Elective Total Knee Arthroplasty: A Prospective, Randomized Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"This prospective randomized controlled trial aims to compare the analgesic efficacy and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine. Patients will be randomized into one of three groups: standard ACB + iPACK without adjuvants, ACB + iPACK with intravenous dexamethasone 8 mg, or ACB + iPACK with intravenous dexamethasone 8 mg combined with perineural dexmedetomidine added to both regional blocks.\n\nThe primary outcome will be total postoperative opioid consumption during the first 48 hours after surgery expressed as intravenous morphine equivalents. Secondary outcomes will include pain intensity at rest and during movement, duration of analgesia, time to first rescue analgesia, quadriceps muscle strength, early mobilization, adverse events, inflammatory markers, and length of hospital stay.","conditions":["Knee Osteoarthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ropivacaine 0.2% Injectable Solution"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Dexmedetomidine"}],"enrollment":120,"startDate":"2026-05-20","completionDate":"2027-09-01","sex":"ALL","minAge":"60 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 60 and 100 years\n* Scheduled for elective primary unilateral total knee arthroplasty\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Ability to understand study procedures and provide written informed consent\n* Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication\n* Contraindications to spinal anesthesia or peripheral nerve blocks\n* Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia\n* Infection at the planned puncture site or systemic infection\n* Severe neurological disorders affecting lower limb sensory or motor function\n* Severe hepatic, renal, or uncontrolled cardiovascular disease\n* Clinically significant bradycardia or advanced atrioventricular conduction abnormalities\n* Chronic opioid use for more than 3 months before surgery\n* Uncontrolled diabetes mellitus or contraindications to dexamethasone administration\n* Inability or refusal to provide written informed consent","locations":[{"facility":"The John Paul II Catholic University of Lublin","city":"Lublin","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Malgorzata Reysner, MD PhD","phone":"+48 61 8310122","email":"mreysner@ump.edu.pl"},{"name":"Tomasz Reysner, MD PhD","phone":"+48 61 8310122","email":"treysner@ump.edu.pl"}],"primaryOutcomes":["Total postoperative opioid consumption during the first 48 hours after surgery"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["lublin-poland","poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: testing Ropivacaine 0.2% Injectable Solution for Knee Osteoarthritis","inPlainEnglish":"This prospective randomly assigned controlled trial aims to compare the analgesic how well it works and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia. All participants will receive standardized spinal anesthesia with 0.5% ropivacaine combined with ACB and iPACK blocks using 0.2% ropivacaine.","whoItsFor":["Ages 60 Years to 100 Years","Age between 60 and 100 years","Scheduled for elective primary unilateral total knee arthroplasty","American Society of Anesthesiologists (ASA) physical status I-III","Eligibility for spinal anesthesia and ultrasound-guided regional anesthesia according to institutional standards"],"whoShouldSkip":["Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any study-related medication","Contraindications to spinal anesthesia or peripheral nerve blocks","Coagulation disorders or anticoagulant therapy preventing safe regional anesthesia","Infection at the planned puncture site or systemic infection","Severe neurological disorders affecting lower limb sensory or motor function","Severe hepatic, renal, or uncontrolled cardiovascular disease","Clinically significant bradycardia or advanced atrioventricular conduction abnormalities"],"whatHappens":"If you join, the listed intervention(s) are Ropivacaine 0.2% Injectable Solution, Dexamethasone, or Dexmedetomidine. The registry lists allocation as randomized. This prospective randomly assigned controlled trial aims to compare the analgesic how well it works and safety of three adjuvant strategies for ultrasound-guided Adductor Canal Block (ACB) and iPACK block in patients undergoing elective total knee arthroplasty under spinal anesthesia.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.512Z"},{"nctId":"NCT07679282","title":"A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults","officialTitle":"Comparative Effectiveness of Positive Airway Pressure Therapy, Dental Device, and Atomoxetine-Oxybutynin for Sleep Apnea: the ADAPT-OSA Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Sairam Parthasarathy","sponsorClass":"OTHER","summary":"Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible participants will be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions. Over the course of one year, participants will attend two in-person visits and take part in four phone check-ins to complete surveys, report any side effects, and discuss how well they are following their assigned treatment.","conditions":["Obstructive Sleep Apnea (OSA)"],"keywords":["Sleep apnea treatments","Dental device for sleep","Positive airway pressure","Atomoxetine-oxybutynin","Comparative effectiveness"],"interventions":[{"type":"DEVICE","name":"Positive airway pressure (PAP) therapy"},{"type":"DEVICE","name":"Sleep dental device"},{"type":"DRUG","name":"Atomoxetine-oxybutynin"}],"enrollment":2400,"startDate":"2026-09-04","completionDate":"2030-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Obstructive sleep apnea (AHI \\>/= 5 per hour), diagnosed in the past 6 months\n* Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness\n* Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)\n* Health insurance of any type\n\nExclusion Criteria:\n\n* Prior treatment for OSA in past year\n* Central sleep apnea or narcolepsy\n* Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)\n* Heart failure with reduced ejection fraction of \\</= 45%\n* Active coronary artery disease (angina or infarction within 3 months of enrollment)\n* Current untreated depression\n* Untreated narrow angle glaucoma\n* Untreated hypothyroidism\n* Clinically significant gastric retention\n* Clinically significant urinary retention\n* History of liver disease\n* Seizure disorder\n* Pregnant or nursing, or plans to become pregnant within the year\n* Concomitant medication use that is incompatible with atomoxetine or oxybutynin\n* Participation in another clinical study with an investigational product","locations":[{"facility":"Banner University Medical Center Tucson","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stanford Medical Center","city":"Redwood City","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Miller School of Medicine","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Heidi Erickson, BSN, RN","phone":"1-520-626-5287","email":"herickso@arizona.edu"}],"primaryOutcomes":["Health-related quality of life"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["tucson-arizona","redwood-city-california","miami-florida","baltimore-maryland"],"enrichment":{"headline":"Phase 4: testing Atomoxetine-oxybutynin for Obstructive Sleep Apnea (OSA)","inPlainEnglish":"Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently. Eligible you would be randomly assigned one of three OSA treatments: traditional PAP therapy, a dental device, or a combination of two FDA-approved medications (atomoxetine and oxybutynin) that are currently approved for other conditions.","whoItsFor":["Ages 18 Years to any","Obstructive sleep apnea (AHI \\>/= 5 per hour), diagnosed in the past 6 months","Two or more of the following symptoms: snoring, fragmented sleep, witnessed apneas, or daytime sleepiness","Willingness/ability to use any of the 3 treatments for OSA (PAP, dental device, or atomoxetine-oxybutynin)","Health insurance of any type"],"whoShouldSkip":["Prior treatment for OSA in past year","Central sleep apnea or narcolepsy","Contraindication for dental device (temporomandibular joint problems, severe periodontal disease, insufficient dentition)","Heart failure with reduced ejection fraction of \\</= 45%","Active coronary artery disease (angina or infarction within 3 months of enrollment)","Current untreated depression","Untreated narrow angle glaucoma"],"whatHappens":"If you join, the listed intervention(s) are Positive airway pressure (PAP) therapy, Sleep dental device, or Atomoxetine-oxybutynin. The registry lists allocation as randomized. Researchers want to identify which treatments for obstructive sleep apnea (OSA) work best and are easiest for patients to use consistently.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 2,400 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.949Z"},{"nctId":"NCT07679828","title":"Polypills Approach for Multiple Cardiovascular Risk Factors","officialTitle":"Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"China Medical University, China","sponsorClass":"OTHER","summary":"The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes compared with usual care at Phase 2.","conditions":["Hypertension","Dyslipidemia","Diabetes"],"keywords":["Hypertension","Dyslipidemia","Diabetes","Polypill","Cardiovascular disease risk","Cardiovascular Diseases","Cognitive function","Randomized controlled trial"],"interventions":[{"type":"DRUG","name":"Fixed-Dose Combination Strategy"}],"enrollment":8252,"startDate":"2026-07-11","completionDate":"2029-12-31","sex":"ALL","minAge":"50 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Men or women\n* Age ≥50 years and \\<75 years\n* Systolic blood pressure ≥130 mmHg\n* LDL-C ≥1.8 mmol/L (70 mg/dL)\n* Type 2 diabetes with HbA1c ≥6.5% and \\<12%\n* Willing to participate and able to sign informed consent\n\nExclusion Criteria:\n\n* Known secondary cause of hypertension\n* Type 1 diabetes\n* Pancreatic insufficiency or diabetes secondary to pancreatitis\n* Triglycerides ≥5.65 mmol/L (500 mg/dL)\n* History of myocardial infarction, stroke, or heart failure\n* History of coronary, cerebrovascular, or peripheral arterial revascularization\n* Abnormal kidney function, defined as estimated glomerular filtration rate \\<30 mL/min/1.73 m² or dialysis\n* Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal\n* Abnormal serum potassium, defined as serum potassium \\>5.5 mmol/L or \\<3.5 mmol/L\n* Contraindication to any of the components of the polypill\n* Currently living with another PACIF participant\n* Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control\n* Clinical diagnosis of dementia or treatment with medications for dementia\n* History of malignancy\n* Life expectancy \\<3 years\n* Currently participating in another intervention study\n* Any factors judged by the clinic team to be likely to limit adherence to interventions","locations":[{"facility":"The First Affiliated Hospital of Henan University of Chinese Medicine","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Chifeng University","city":"Chifeng","state":"Inner Mongolia","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tongliao People's Hospital","city":"Tongliao","state":"Inner Mongolia","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kunshan Hospital of Chinese Medicine","city":"Kunshan","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Suzhou Wujiang District Hospital of Traditional Chinese Medicine","city":"Suzhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fifth People's Hospital of Wujiang District","city":"Suzhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Soochow University","city":"Suzhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taixing Second People's Hospital","city":"Taizhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Central Hospital of Jinzhou","city":"Jinzhou","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Panjin Central Hospital","city":"Panjin","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"First Hospital of China Medical University","city":"Shenyang","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shengjing Hospital of China Medical University","city":"Shenyang","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tieling Central Hospital","city":"Tieling","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tiemei General Hospital of Liaoning Health Industry Group","city":"Tieling","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shandong Provincial Hospital Affiliated to Shandong First Medical University","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["10-year CVD risk","Composite cardiovascular disease outcome"],"hasResults":false,"conditionSlugs":["type-2-diabetes","hypertension"],"drugSlugs":[],"locationSlugs":["zhengzhou-china","chifeng-china","tongliao-china","kunshan-china","suzhou-china","taizhou-china","jinzhou-china","panjin-china","shenyang-china","tieling-china","jinan-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Fixed-Dose Combination Strategy for Hypertension","inPlainEnglish":"The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomly assigned controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1.","whoItsFor":["Ages 50 Years to 75 Years","Age ≥50 years and \\<75 years","Systolic blood pressure ≥130 mmHg","LDL-C ≥1.8 mmol/L (70 mg/dL)","Type 2 diabetes with HbA1c ≥6.5% and \\<12%"],"whoShouldSkip":["Known secondary cause of hypertension","Pancreatic insufficiency or diabetes secondary to pancreatitis","Triglycerides ≥5.65 mmol/L (500 mg/dL)","History of myocardial infarction, stroke, or heart failure","History of coronary, cerebrovascular, or peripheral arterial revascularization","Abnormal kidney function, defined as estimated glomerular filtration rate \\<30 mL/min/1.73 m² or dialysis","Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \\>3 times the upper limit of normal"],"whatHappens":"If you join, the listed intervention(s) are Fixed-Dose Combination Strategy. The registry lists allocation as randomized. The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomly assigned controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 8,252 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.973Z"},{"nctId":"NCT07680140","title":"Biomarker-Guided Antidepressant Selection","officialTitle":"Biomarker-Guided Antidepressant Selection for Treatment-Resistant Depression","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Weill Medical College of Cornell University","sponsorClass":"OTHER","summary":"Depression is one of the leading causes of disability worldwide. Common treatments like antidepressant medications and talk therapy work well for some people, but many others do not improve, even after trying multiple treatments.\n\nThis study will investigate two alternative treatment options for people whose depression has not responded to standard treatments: repetitive transcranial magnetic stimulation (rTMS), a non-invasive form of brain stimulation, and ketamine, a fast-acting medication. It can be difficult to decide between these interventions in clinical practice, and selecting between them often comes down to patient preference and trial and error. This study is working to optimize the selection approach: using biological and behavioral markers to match each person to identify biomarkers that may predict response to rTMS or ketamine. Investigators believe that differences in how individuals respond to rTMS versus ketamine are partly explained by differences in how their brains are organized, and that these differences can be measured and used to guide intervention decisions. This is an early-stage pilot study designed to test whether this biomarker-based approach is practical and acceptable to patients. Investigators will evaluate how well a combination of brain imaging and clinical data can predict, at the individual level, who is likely to respond to rTMS versus ketamine. The ultimate goal is to develop a reliable, scalable tool that helps clinicians make faster and more informed intervention decisions, reducing the time people with treatment-resistant depression spend searching for an antidepressant that works.","conditions":["Depression - Major Depressive Disorder","Treatment-resistant Depression (TRD)","rTMS","Ketamine","fMRI"],"keywords":[],"interventions":[{"type":"DEVICE","name":"TMS"},{"type":"DRUG","name":"Ketamine"}],"enrollment":27,"startDate":"2026-08-10","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Adults of all genders aged 18-70 at the time of screening\n3. Diagnosis of Major Depressive Disorder (by DSM-5 criteria)\n4. Depressive symptoms of at least moderate severity (GRID HDRS-17 score \\>= 14 or as determined by a study clinician)\n5. Failed at least 1 prior trial of standard first-line treatment for MDD per the modified Antidepressant Treatment History form, the Maudsley Staging Method, and APA Practice Guidelines (e.g., SSRI, SNRI, CBT) OR initiated and discontinued a trial of a first-line treatment for MDD (e.g. could not tolerate side effects, etc.)\n6. Not currently taking antidepressants OR on a stable dose of antidepressant for at least 1month prior to screening and plans to remain off antidepressants OR on this stable dose for the duration of participation\n7. Current medication regimen is compatible with safe participation in the trial in the assessment of a study clinician\n8. Access to psychiatric care before, during, and after completion of the study\n9. For females of reproductive potential: agreement to use effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation\n10. Proficiency in English sufficient to complete assessments and follow study procedure instructions\n11. Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n1. Imminent risk of suicide\n2. Presence of primary psychiatric diagnosis other than MDD (e.g., post-traumatic stress disorder, obsessive-compulsive disorder, MDD with psychotic features, primary psychotic illness, bipolar I or II disorder)\n3. History of epilepsy or a history of seizures that would influence the participant's risk for TMS-evoked seizures; history of any condition / concurrent medication that could notably lower seizure threshold in the estimation of a study clinician\n4. Met criteria for any clinically significant substance use disorder (by DSM-V criteria) with active substance misuse in the 6 months prior to screening\n5. Lifetime history of PCP/ketamine abuse\n6. History or presence of significant neurological disorder that may be contributing to current depressive symptoms in the judgment of a study clinician (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy)\n7. Presence of medical contraindications to ketamine, including liver function tests \\> 2.5x normal limit, recent myocardial infarction, congestive heart failure \\> stage 2, angina pectoris, clinically significant bradycardia or tachycardia at the baseline assessment, or uncontrolled hypertension\n8. MRI contraindication, including presence of ferromagnetic foreign metal bodies or implants, implanted or conductive ferromagnetic objects in or near the head (e.g., stents, deep brain stimulators, vagus nerve stimulators, aneurysm coils, ocular implants, cochlear implants), and ferromagnetic permanent make-up that may undergo heating in an MRI scanner\n9. Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation\n10. Abnormal bloodwork that may be contributing to depressive symptoms in the estimation of a study clinician (e.g. indicators of clinically significant hypothyroidism, kidney failure, liver failure, etc.)\n11. History or presence of any disorder or medical condition that, in the opinion of the study team, may compromise, interfere, or limit the individual's ability to complete the intervention or study procedures","locations":[{"facility":"Ichan School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Coordinator, Interventional Psychiatry Program","phone":"646-962-2900","email":"tmsinfo@med.cornell.edu"}],"primaryOutcomes":["Change from Baseline to 2-Week Post-Intervention Score in Hamilton Depression Rating Scale (HDRS) Score"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 4: testing Ketamine for Depression - Major Depressive Disorder","inPlainEnglish":"Depression is one of the leading causes of disability worldwide. Common treatments like antidepressant medications and talk therapy work well for some people, but many others do not improve, even after trying multiple treatments.","whoItsFor":["Ages 18 Years to 70 Years","Adults of all genders aged 18-70 at the time of screening","Diagnosis of Major Depressive Disorder (by DSM-5 criteria)","Depressive symptoms of at least moderate severity (GRID HDRS-17 score \\>= 14 or as determined by a study clinician)","Not currently taking antidepressants OR on a stable dose of antidepressant for at least 1month prior to screening and plans to remain off antidepressants OR on this stable dose for the duration of participation","Current medication regimen is compatible with safe participation in the trial in the assessment of a study clinician","Access to psychiatric care before, during, and after completion of the study","For females of reproductive potential: agreement to use effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation"],"whoShouldSkip":["Imminent risk of suicide","Presence of primary psychiatric diagnosis other than major depression (e.g., post-traumatic stress disorder, obsessive-compulsive disorder, major depression with psychotic features, primary psychotic illness, bipolar I or II disorder)","History of epilepsy or a history of seizures that would influence the participant's risk for TMS-evoked seizures; history of any condition / concurrent medication that could notably lower seizure threshold in the estimation of a study clinician","Met criteria for any clinically significant substance use disorder (by DSM-V criteria) with active substance misuse in the 6 months prior to screening","Lifetime history of PCP/ketamine abuse","History or presence of significant neurological disorder that may be contributing to current depressive symptoms in the judgment of a study clinician (e.g., traumatic brain injury, stroke, Parkinson's disease or other movement disorder, epilepsy)","Individuals who are nursing, pregnant, or contemplating pregnancy within the length of study participation"],"whatHappens":"If you join, the listed intervention(s) are TMS, or Ketamine. The registry lists allocation as randomized. Depression is one of the leading causes of disability worldwide.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 27 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.110Z"},{"nctId":"NCT07680790","title":"Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)","officialTitle":"A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Bristol-Myers Squibb","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy","conditions":["Non-Small Cell Lung Cancer"],"keywords":["NSCLC","EGFR","First line","Izalontamab brengitecan","Osimertinib","ADC","IZABRIGHT-Lung02"],"interventions":[{"type":"DRUG","name":"Iza-bren"},{"type":"DRUG","name":"Osimertinib"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Cisplatin"}],"enrollment":850,"startDate":"2026-09-08","completionDate":"2031-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment\n* Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)\n* Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator\n* Participants must have ECOG Performance Status 0-1\n\nExclusion Criteria:\n\n* Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression\n* Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis\n* Participants must not have clinically significant cardiac disease\n* Other protocol-defined inclusion/exclusion criteria apply.","locations":[{"facility":"Local Institution - 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3: testing Iza-bren for Non-Small Cell Lung Cancer","inPlainEnglish":"This study wants to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy","whoItsFor":["Ages 18 Years to any","Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatment","Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution)","Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator","Participants must have how well you can do daily activities (ECOG score) 0-1"],"whoShouldSkip":["Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression","Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis","Participants must not have clinically significant cardiac disease","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Iza-bren, Osimertinib, or Pemetrexed. The registry lists allocation as randomized. This study wants to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 850 people at 205 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.712Z"},{"nctId":"NCT07680946","title":"Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia","officialTitle":"Evaluating Safety and Efficacy of Ublituximab in Participants With Schizophrenia","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"TG Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The main objective of this Phase 2 study is to assess the efficacy of ublituximab as measured by Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia.","conditions":["Schizophrenia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ublituximab"}],"enrollment":60,"startDate":"2026-07-27","completionDate":"2028-12-12","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Primary diagnosis of schizophrenia.\n2. Treatment-resistant.\n3. Requires antipsychotic treatment and is currently receiving \"standard of care\".\n4. PANSS total score between 80 and 120, inclusive at screening and baseline.\n\nExclusion Criteria\n\n1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia.\n2. Ongoing clozapine treatment.\n3. Risk for suicidal behavior.\n4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate.\n\nNote: Other protocol-specified Inclusion/Exclusion criteria may apply","locations":[{"facility":"TG Therapeutics Investigational Trial Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TG Therapeutics Investigational Trial Site","city":"Richardson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"TG Therapeutics Clinical Support Team","phone":"1-877-575-8489","email":"clinicalsupport@tgtxinc.com"}],"primaryOutcomes":["Percentage of Participants with at Least 20% Reduction From Baseline in PANSS Total Score"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","richardson-texas"],"enrichment":{"headline":"Phase 2: testing Ublituximab for Schizophrenia","inPlainEnglish":"The main objective of this Phase 2 study is to assess the how well it works of ublituximab as measured by Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia.","whoItsFor":["Ages 18 Years to 60 Years","Primary diagnosis of schizophrenia","Treatment-resistant","Requires antipsychotic treatment and is currently receiving \"standard of care\"","PANSS total score between 80 and 120, inclusive at screening and baseline"],"whoShouldSkip":["Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia","Ongoing clozapine treatment","Risk for suicidal behavior","Any severe or uncontrolled medical condition that could affect the participant's ability to participate","Note: Other protocol-specified Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Ublituximab. The registry lists allocation as na. The main objective of this Phase 2 study is to assess the how well it works of ublituximab as measured by Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.043Z"},{"nctId":"NCT07682961","title":"Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","officialTitle":"A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.\n\nThe primary objective of this study are to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.","conditions":["HIV Infections"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lenacapavir"},{"type":"DRUG","name":"Lenacapavir Tablet"},{"type":"DRUG","name":"Teropavimab"},{"type":"DRUG","name":"Zinlirvimab"},{"type":"DRUG","name":"Cabotegravir"},{"type":"DRUG","name":"Rilpivirine"}],"enrollment":590,"startDate":"2026-07-14","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:\n\n  1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.\n* At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and \\< 400 copies/mL (transient detectable viremia or \"blips\") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \\< 50 copies/mL.\n* A plasma HIV-1 RNA test \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening.\n\n  1\\) If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).\n* On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening.\n\n  1. A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (VF) (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be \\< 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.\n\nKey Exclusion Criteria:\n\n* History of an opportunistic infection or illness indicative of Stage 3 HIV disease.\n* History of treatment failure.\n* Known or suspected resistance to either CAB or RPV.\n\n  1. Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H.\n  2. Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N.\n* Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV.\n* Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.\n* Active, serious infections (other than HIV-1) requiring therapy \\< 30 days prior to randomization.\n* Active tuberculosis infection.\n* Acute hepatitis of any cause \\< 30 days before randomization.\n* History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).\n* Active malignancy requiring acute systemic therapy.\n* Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.\n* Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.\n* Prior use of, or exposure to, long-acting (LA) injectable CAB or LA injectable RPV.\n* Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.\n* Baseline regimen consisting of monotherapy with any single antiretroviral (ARV).\n* Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.\n* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.\n* Chronic hepatitis B virus (HBV) infection, as determined by either:\n\n  1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.\n  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.\n* Severe renal impairment-estimated glomerular filtration rate \\< 30 mL/min according to the Cockcroft-Gault formula.\n* Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.\n* Any of the following laboratory values at screening:\n\n  1. Alanine aminotransferase \\> 5 x upper limit of normal (ULN).\n  2. Direct bilirubin \\> 1.5 x ULN.\n  3. Platelets \\< 50,000/mm\\^3.\n  4. Hemoglobin \\< 8.0 g/dL.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Optimus Medical Group","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midland Florida Clinical Research Center, LLC","city":"DeLand","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health Fort Lauderdale","city":"Fort Lauderdale","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midway Immunology and Research Center","city":"Ft. Pierce","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CAN Community Health Miami Gardens","city":"Miami Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"BLISS Health Inc.","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MOORE Clinical Research, Inc d/b/a TrueBlue Clinical Research","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triple O Research Institute, P.A.","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Clinical Research Institute","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlanta ID Group, PC","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chatham County Health Department","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Be Well Medical Center","city":"Berkley","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"KC CARE Health Center","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Texas Infectious Diseases Consultants, P.A.","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)","city":"Annandale","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"TribalMed PLLC","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taylor Square Private Clinic","city":"Surry Hills","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"East Sydney Doctors","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Osaka National Hospital","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Proportion of Participants With HIV-1 ribonucleic acid (RNA) ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm."],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["san-francisco-california","deland-florida","fort-lauderdale-florida","ft-pierce-florida","miami-gardens-florida","orlando-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","savannah-georgia","berkley-michigan","kansas-city-missouri","dallas-texas","annandale-virginia","seattle-washington","surry-hills-australia","sydney-australia","osaka-japan"],"enrichment":{"headline":"Phase 3: testing Lenacapavir for HIV Infections","inPlainEnglish":"The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment. The primary objective of this study are to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus switching to CAB and RPV in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.","whoItsFor":["Ages 18 Years to any","Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:","1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening","A plasma HIV-1 RNA test \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior to screening","1\\) If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)","On a stable oral ARV therapy (ART) for ≥ 6 months prior to screening"],"whoShouldSkip":["History of an opportunistic infection or illness indicative of Stage 3 HIV disease","History of treatment failure","Known or suspected resistance to either CAB or RPV","Resistance to CAB defined as the following mutations: G118R, Q148K, Q148R, T66K+L74M, E92Q+N155H, E138A+Q148R, E138K+Q148K/R, G140C+Q148R, G140S+Q148H/K/R, Y143H+N155H, and Q148R+N155H","Resistance to RPV defined as the following mutations: K101E and P; E138A, G, K, R, and Q; V179L; Y181C, I, and V; Y188L; H221Y; F227C; M230I and L, and the combination of L100I/K103N","Individuals with a dermatologic condition or implanted prothesis overlying the gluteal injection site for CAB + RPV","Known hypersensitivity to the study intervention, its metabolites, or formulation excipients"],"whatHappens":"If you join, the listed intervention(s) are Lenacapavir, Lenacapavir Tablet, or Teropavimab. The registry lists allocation as randomized. The goal of this clinical study is to compare how effective a long-acting injectable treatment of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) versus (CAB) and rilpivirine (RPV) injections given every 8 weeks in adults with HIV-1 whose virus is well controlled on daily oral treatment, after 1 year (52 weeks) of the treatment.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 590 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.399Z"},{"nctId":"NCT07683000","title":"Study of Lenacapavir, Teropavimab, and Zinlirvimab in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens","officialTitle":"A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir Twice-Yearly in Virologically Suppressed Adults With HIV-1 on Stable Oral Treatment Regimens","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment.\n\nThe primary objective of this study is to evaluate the efficacy of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.","conditions":["HIV-1-infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lenacapavir"},{"type":"DRUG","name":"Lenacapavir Tablet"},{"type":"DRUG","name":"Teropavimab"},{"type":"DRUG","name":"Zinlirvimab"},{"type":"DRUG","name":"SBR"}],"enrollment":590,"startDate":"2026-07-14","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:\n\n  1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening.\n* Plasma HIV-1 RNA levels \\< 50 copies/mL at screening.\n* At least 1 documented HIV-1 RNA level measured between 6 months and 12 months (+2 months) prior to screening. This and any other HIV-1 RNA measurements documented in this period must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL). A single virologic elevation of ≥ 50 copies/mL and \\< 400 copies/mL (transient detectable viremia or \"blips\") prior to screening are acceptable if the subsequent plasma HIV-1 RNA level is \\< 50 copies/mL.\n* A plasma HIV-1 RNA test \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior.\n* If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL).\n* On a stable oral antiretroviral (ARV) therapy (ART) for ≥ 6 months prior to screening.\n* A change in ART regimen ≥ 3 months prior to the screening visit for reasons other than virologic failure (eg, tolerability, simplification, drug-drug interaction profile) is allowed; individuals with a change in ART regimen ≥ 3 months prior to screening must have been on the regimen for ≥ 3 months prior to screening, and all HIV-1 RNA measurements in that period must be \\< 50 copies/mL. There are no permitted changes to ART regimens between screening and Day 1.\n\nKey Exclusion Criteria:\n\n* History of an opportunistic infection or illness indicative of Stage 3 HIV disease.\n* Known hypersensitivity to the study intervention, its metabolites, or formulation excipients.\n* Active, serious infections (other than HIV-1) requiring therapy \\< 30 days prior to randomization.\n* Active tuberculosis infection.\n* Acute hepatitis of any cause \\< 30 days before randomization.\n* History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C).\n* Active malignancy requiring acute systemic therapy.\n* Have poor venous access that would limit phlebotomy or intravenous (IV) infusion of study drugs.\n* Prior use of, or exposure to, LEN or a broadly neutralizing antibody (bNAb) for HIV-1.\n* Prior use of, or exposure to, long-acting (LA) injectable cabotegravir (CAB) or LA injectable rilpivirine (RPV).\n* Prior use of, or exposure to, ibalizumab, fostemsavir, or maraviroc.\n* Current use of, or exposure to, nevirapine or zidovudine.\n* Baseline regimen consisting of monotherapy with any single ARV.\n* Treatment with immunosuppressant therapies (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies) within 4 weeks of screening (with the exception of a single short course of corticosteroids lasting ≤ 7 days) or have a comorbid condition with an anticipated need ongoing immunosuppressive treatment during the study.\n* Hepatitis C virus (HCV) antibody positive and HCV RNA detectable.\n* Chronic hepatitis B virus (HBV) infection, as determined by either:\n\n  1. Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit.\n  2. Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit.\n\nNote: Individuals found to be susceptible to HBV infection (eg, negative hepatitis B surface antibody at the screening visit, regardless of prior HBV vaccination history) should be recommended to receive an HBV vaccination. Those who remain non-immune will receive regular testing for HBV.\n\n* Severe renal impairment-estimated glomerular filtration rate \\< 30 mL/min according to the Cockcroft-Gault formula.\n* Abnormal electrocardiogram (ECG) at the screening visit that is clinically significant, as determined by the investigator.\n* Any of the following laboratory values at screening:\n\n  1. Alanine aminotransferase \\> 5 × upper limit of normal (ULN).\n  2. Direct bilirubin \\> 1.5 × ULN\n  3. Platelets \\< 50,000/mm\\^3.\n  4. Hemoglobin \\< 8.0 g/dL.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Be Well Medical Center","city":"Berkeley","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)","city":"Annandale","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Proportion of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Defined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm."],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["berkeley-michigan","annandale-virginia"],"enrichment":{"headline":"Phase 3: testing Lenacapavir for HIV-1-infection","inPlainEnglish":"The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment. The primary objective of this study is to measure the how well it works of switching to the regimen of LEN, TAB, and ZAB versus continuing an oral stable baseline regimen (SBR) in virologically suppressed people with HIV-1 (PWH) as determined by the proportion of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52.","whoItsFor":["Ages 18 Years to any","Human immunodeficiency virus type 1 (HIV-1) susceptibility results from screening meeting specific criteria:","1\\) Proviral phenotypic susceptibility to both TAB and ZAB by the investigational protocol-defined assay at screening","Plasma HIV-1 RNA levels \\< 50 copies/mL at screening","A plasma HIV-1 RNA test \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL) within the last 6 months prior","If \\> 1 plasma HIV-1 RNA measurements in the last 6 months prior to screening are available, all must be \\< 50 copies/mL (undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)","On a stable oral antiretroviral (ARV) therapy (ART) for ≥ 6 months prior to screening"],"whoShouldSkip":["History of an opportunistic infection or illness indicative of Stage 3 HIV disease","Known hypersensitivity to the study intervention, its metabolites, or formulation excipients","Active, serious infections (other than HIV-1) requiring therapy \\< 30 days prior to randomization","Active tuberculosis infection","Acute hepatitis of any cause \\< 30 days before randomization","History of, or current clinical decompensated liver cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or severe hepatic impairment (Child-Pugh Class C)","Active malignancy requiring acute systemic therapy"],"whatHappens":"If you join, the listed intervention(s) are Lenacapavir, Lenacapavir Tablet, or Teropavimab. The registry lists allocation as randomized. The goal of this clinical study is to compare how effective a long-acting treatment of injectable combination of lenacapavir (LEN), teropavimab (TAB), and zinlirvimab (ZAB) is versus continuing a daily oral HIV treatment in adults with HIV-1 whose virus is already well controlled, after 1 year (52 weeks) of treatment.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 590 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.399Z"},{"nctId":"NCT07683065","title":"A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD","officialTitle":"SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \\[PsA\\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.","conditions":["Plaque Psoriasis","Metabolic Dysfunction-Associated Steatotic Liver Disease"],"keywords":["Plaque psoriasis","MASLD Hepatic Biomarkers Trajectories"],"interventions":[],"enrollment":150,"startDate":"2026-07-08","completionDate":"2027-01-15","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023.\n* Patients aged ≥18 years at index date.\n* Patients with no prior secukinumab exposure in available EMR history.\n* Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA).\n* Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC).\n* Patients with confirmed plaque psoriasis with or without PsA.\n* Patients with at least one cardiometabolic risk factor.\n* Patients with a confirmed MASLD diagnosis.\n* Patients with baseline laboratory data available.\n\nExclusion criteria:\n\n* Patients with evidence of MASLD absence.\n* Patients with malignant liver disease.\n* Patients with a history of liver transplantation.\n* Patients with alcohol use disorder.\n* Patients with other chronic liver diseases.\n* Patients with diseases or treatments which cause thrombocytopenia.\n* Patients with decompensated cirrhosis.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Novartis Investigative Site","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"San Cristóbal de La Laguna","state":"Santa Cruz De Tenerife","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Number of Definitive Discontinuation Events Per Patient-Year"],"hasResults":false,"conditionSlugs":["als","psoriasis"],"drugSlugs":[],"locationSlugs":["badalona-spain","san-crist-bal-de-la-laguna-spain","barcelona-spain","madrid-spain","m-laga-spain","valencia-spain","zaragoza-spain"],"enrichment":{"headline":"A Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD","inPlainEnglish":"This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis \\[PsA\\]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.","whoItsFor":["Ages 18 Years to 100 Years","Patients with a first recorded secukinumab prescription between 01 January 2021 and 31 December 2023","Patients aged ≥18 years at index date","Patients with no prior secukinumab exposure in available EMR history","Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA)","Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC)","Patients with confirmed plaque psoriasis with or without PsA","Patients with at least one cardiometabolic risk factor"],"whoShouldSkip":["Patients with evidence of MASLD absence","Patients with malignant liver disease","Patients with a history of liver transplantation","Patients with alcohol use disorder","Patients with other chronic liver diseases","Patients with diseases or treatments which cause thrombocytopenia","Patients with decompensated cirrhosis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.571Z"},{"nctId":"NCT07683754","title":"T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd","officialTitle":"A Global, Interventional, Open-label Trial of T-DXd-based Therapy Followed by Palbociclib, Endocrine Therapy and Dual HER2 Blockade in First-line HER2+/ HR+ Advanced or Metastatic Breast Cancer and Retreatment With T-DXd (DB-Guide)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.","conditions":["Advanced Breast Cancer","Metastatic Breast Cancer","HER2 Positive","HR Positive"],"keywords":["Advanced Breast Cancer","Metastatic Breast Cancer","T-DXd","HER2 positive","HR positive"],"interventions":[{"type":"DRUG","name":"Trastuzumab deruxtecan"},{"type":"DRUG","name":"Trastuzumab"},{"type":"DRUG","name":"Pertuzumab"},{"type":"DRUG","name":"Endocrine Therapy"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":200,"startDate":"2026-09-18","completionDate":"2030-07-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria for Upfront Treatment Phase\n\n1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.\n2. Participant must be ≥18 years of age at the time the ICF is signed.\n3. Have pathologically documented breast cancer that:\n\n   * Is locally advanced and unresectable or metastatic (participants who can be treated with curative intent are not eligible).\n   * Participant must have histologically confirmed HER2+ and HR+ (ER+ and/or PR+), mBC. ER, PR, and HER2 measurements should be locally performed according to institutional guidelines.\n   * Is documented by local testing as HR-positive (either ER and/or PgR positive \\[ER or PgR ≥1%\\]) per ASCO/CAP guidelines in the metastatic setting or from the primary tumor with the latest sample available.\n4. Has not received prior chemotherapy or HER2-targeted therapy for mBC. Participant who has received chemotherapy or HER2-targeted therapy or radiotherapy or surgery in the neoadjuvant or adjuvant setting are eligible, with a DFI of \\>6 months (\\>183 days) from completion of systemic chemotherapy or any HER2-targeted therapy (antibody, TKI or T-DM1) to diagnosis of advanced or metastatic disease.\n5. ECOG PS of 0 or 1 assessed no more than 3 days prior to initiation of trial intervention.\n6. Has at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short axis ≥15 mm) with CT or MRI, which is suitable for accurate repeated measurements, or nonmeasurable, bone-only disease that can be assessed by CT, MRI, or X-ray.\n7. Participant with brain metastases are allowed if participant is asymptomatic and does not require immediate local intervention.\n\nAdditional Key Criteria to Transition into the Maintenance Treatment Phase\n\n1\\. Participant transitioning into the Maintenance Treatment Phase must meet the following inclusion criteria for Maintenance Treatment:\n\n* Participant is without evidence of disease progression under T-DXd + pertuzumab treatment by local assessment according to RECIST v1.1 (ie, CR, PR, or SD), and\n* Participant is willing to switch therapy, and\n* Participant completed at least 8 cycles of T-DXd + pertuzumab and achieved cCR (confirmation of CR should be obtained during the next protocol defined scheduled tumor assessment.), or\n* Participant completed 18 cycles (in total) of T-DXd and achieved a SD or PR, and the last 2 scans showed no further tumor shrinkage (defined as 2 subsequent scans at least 6 weeks apart) or has an unconfirmed CR.\n\nAdditional Key Criteria for T-DXd Retreatment Phase\n\n1. Has received at least 1 dose of Maintenance Treatment.\n2. Has documented disease progression per RECIST v1.1 per investigator assessment during Maintenance Treatment.\n3. Participant who experienced ILD Grade 1 during the Maintenance Treatment Phase, must have fully resolved before starting T-DXd during the Retreatment Phase.\n\nKey Exclusion Criteria for Upfront Treatment Phase\n\n1. Has prior therapy with any CDK inhibitor.\n2. Previous T-DXd therapy for early BC with an EFS or disease-free interval of \\< 12 months from completion of T-DXd therapy in the neoadjuvant or post-neoadjuvant setting.\n\nKey Exclusion Criteria for Maintenance Treatment Phase\n\n1. Is receiving concurrent therapy with other trial interventions (except pertuzumab which is part of Upfront Treatment and Maintenance Treatment).\n2. Has prior therapy with any CDK inhibitor.\n3. Has any unresolved SAE related to prior T-DXd + pertuzumab treatment from the Upfront Treatment Phase, defined as an event that has not resolved to baseline by the time of the eligibility assessment for the Maintenance Treatment Phase.\n4. Has experienced Grade 3 or 4 ILD/pneumonitis during the Upfront Treatment Phase.\n5. Has spinal cord compression or clinically active CNS metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.\n\nKey Exclusion Criteria for T-DXd Retreatment Phase\n\n1. Participant who developed ILD/pneumonitis Grade ≥2 during the Upfront Treatment Phase or Maintenance Treatment Phase.\n2. Participant has any unresolved SAE related to prior Maintenance Treatment Phase therapies defined as an event that has not resolved to baseline by the time of the eligibility assessment for the T-DXd Retreatment Phase.\n3. Participant who developed non-ILD toxicities related to T-DXd in the Upfront Treatment Phase that required T-DXd discontinuation.","locations":[{"facility":"Maryland Oncology Hematology, P.A.","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Comprehensive Cancer Centers of Nevada","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - West Texas","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - San Antonio","city":"New Braunfels","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Contact for Clinical Trial Information","phone":"908-992-6400","email":"CTRinfo_us@daiichisankyo.com"}],"primaryOutcomes":["Progression-free Survival (PFS) Rate at 24 Months"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":["trastuzumab-deruxtecan","palbociclib"],"locationSlugs":["columbia-maryland","las-vegas-nevada","nashville-tennessee","el-paso-texas","new-braunfels-texas"],"enrichment":{"headline":"Phase 3: testing Trastuzumab deruxtecan for Advanced Breast Cancer","inPlainEnglish":"This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.","whoItsFor":["Ages 18 Years to any","Key for Upfront Treatment Phase","Participant must be ≥18 years of age at the time the ICF is signed","Have pathologically documented breast cancer that:","Is locally advanced and unresectable or metastatic (participants who can be treated with curative intent are not eligible)","Participant must have histologically confirmed HER2+ and HR+ (ER+ and/or PR+), mBC. ER, PR, and HER2 measurements should be locally performed according to institutional guidelines","Is documented by local testing as HR-positive (either ER and/or PgR positive \\[ER or PgR ≥1%\\]) per ASCO/CAP guidelines in the metastatic setting or from the primary tumor with the latest sample available","ECOG PS of 0 or 1 assessed no more than 3 days prior to initiation of trial intervention"],"whoShouldSkip":["for Upfront Treatment Phase","Has prior therapy with any CDK inhibitor","Previous T-DXd therapy for early BC with an EFS or disease-free interval of \\< 12 months from completion of T-DXd therapy in the neoadjuvant or post-neoadjuvant setting"],"whatHappens":"If you join, the listed intervention(s) are Trastuzumab deruxtecan, Trastuzumab, or Pertuzumab. The registry lists allocation as na. This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 200 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.358Z"},{"nctId":"NCT07684599","title":"A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)","officialTitle":"A Randomized, Open-label, Multicenter, Phase 3 Study to Investigate Mocertatug Rezetecan in Combination With Immune Checkpoint Inhibition for Maintenance Treatment of Participants With Mismatch Repair Proficient (MMRp) Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of care and will help us better understand its impact on Health-Related Quality of Life of participants.","conditions":["Neoplasms, Endometrial"],"keywords":["Mocertatug rezetecan","Mo-Rez","GSK5733584","Dostarlimab","Pembrolizumab","Endometrial Cancer","Antibody-Drug Conjugate","BEHOLD-Endometrial02"],"interventions":[{"type":"DRUG","name":"Mocertatug rezetecan"},{"type":"DRUG","name":"Dostarlimab"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":610,"startDate":"2026-09-24","completionDate":"2029-07-23","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF).\n* Has received 6 cycles of first-line therapy (i.e. induction therapy), consisting of platinum-based doublet chemotherapy (e.g., carboplatin/paclitaxel) with immune checkpoint inhibition as part of standard of care (either pembrolizumab or dostarlimab) or via trial Run-In (dostarlimab). Receipt of only 4 cycles of chemotherapy is permitted if chemotherapy was discontinued due to toxicity, provided that the participant received at least 12 weeks of immune checkpoint inhibitor therapy during the induction period.\n* Is able to commence C1D1 of study treatment within 3 - 9 weeks of the final dose of first-line therapy.\n* Is deemed suitable to continue with maintenance therapy with immune checkpoint inhibition (dostarlimab or pembrolizumab).\n* Demonstrates no clinical or radiographic progression of disease per investigator after the final dose of induction therapy. Final dose is defined as the last day that either platinum chemotherapy, taxane chemotherapy or immune checkpoint inhibition was given within the last cycle of induction therapy\n* Has histologically confirmed endometrial carcinoma including but not limited to endometrioid, serous, clear cell and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted.\n* Meets one of the following criteria:\n\n  * Has newly diagnosed stage III disease \\[2023 International Federation of Gynecology and Obstetrics (FIGO) staging\\] with measurable residual disease \\>1 cm after primary debulking surgery (incomplete cytoreduction).\n  * Has newly diagnosed stage III disease (2023 FIGO staging) that is not suitable for primary debulking surgery with measurable disease.\n  * Has newly diagnosed stage IV disease (2023 FIGO staging) and any residual disease status (measurable or non-measurable) following debulking surgery. Participants not suitable for primary debulking surgery are also permitted.\n  * Has recurrent disease and is naïve to systemic anticancer therapy and any disease status (measurable or non-measurable).\n  * Has recurrent disease after receiving prior neo-adjuvant/adjuvant systemic anticancer therapy and had a recurrence \\>12 months after last dose of neo-adjuvant/adjuvant treatment. Participants with any disease status (measurable or non-measurable) are permitted.\n* Has a tumor demonstrating either Mismatch Repair proficient (MMRp) or Microsatellite stable (MSS).\n* Has provided a Formalin fixed, paraffin embedded (FFPE) tumor tissue sample sufficient for the central assessment of B7 homolog 4 protein (B7-H4) expression and MMR (if local MMRp/MSS test result(s) not available), with the result of B7-H4 expression testing available prior to date of randomization.\n* Is willing to use adequate contraception. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer.\n* Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas.\n* Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis.\n* Has experienced any of the following with prior immunotherapy: any imAE ≥ Grade 3, immune-mediated severe neurologic events of any grade (e.g., myasthenic syndrome/myasthenia gravis, encephalitis, Guillain-Barré Syndrome, or transverse myelitis), exfoliative dermatitis of any grade (Stevens-Johnson syndrome \\[SJS\\], Toxic Epidermal Necrolysis \\[TEN\\], or Drug Reaction with Eosinophilia and Systemic Symptoms \\[DRESS\\] syndrome, or myocarditis of any grade.\n* Has ongoing adverse reaction(s) from prior therapy that has(have) not recovered to ≤ Grade 1 or to the baseline status preceding prior therapy, excluding alopecia, hearing loss, vitiligo, endocrinopathy managed with replacement therapy, and Grade 2 neuropathy, or adverse reactions that the investigator, with the agreement of the sponsor, considers to be not clinically relevant for the tolerability of study intervention in the current clinical study.\n* Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1.\n* Has received treatment with an investigational agent within 30 days prior to C1D1.\n* Has received prior therapy with topoisomerase I inhibitors (e.g. irinotecan or topotecan) or Antibody-Drug Conjugate (ADC)with a topoisomerase I inhibitor warhead, B7-H4 targeted therapy, or immune checkpoint inhibitor.\n* Has received treatment with inhibitors of P-glycoprotein (P-gp) or Breast cancer resistant protein (BCRP), or OATP1B1/1B3 transporterswithin 7 days prior to the date of C1D1. Inducers of P-gp should be discontinued for at least 14 days prior to the date of C1D1.\n* Has received any transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including Granulocyte-Colony Stimulating Factor \\[G-CSF\\], Granulocyte-Macrophage Colony-Stimulating Factor \\[GM-CSF\\], or recombinant erythropoietin) within 14 days prior to C1D1.\n* Has an Alanine aminotransferase (ALT) value \\>2.5 × Upper limit of normal (ULN) or for participants with documented liver metastases/tumor infiltration has an ALT value \\>5 × ULN.\n* Has a total bilirubin value \\>1.5 × ULN.\n* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice. Participants who exhibit these signs or symptoms as a result of the malignancy under investigation and whose conditions are deemed adequately controlled by the investigator may be eligible for inclusion.\n* Has Corrected QT interval (QTc) \\>470 milliseconds (msec).\n* Has a history of symptomatic pericarditis of any cause within 6 months prior to screening or evidence of cardiac abnormalities within 12 months prior to screening such as serious, uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.\n* Has any active renal condition (e.g., infection, requirement for dialysis, or any other significant renal condition that could affect the participant's safety).","locations":[{"facility":"GSK Investigational Site","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fukushima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Hokkaido","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Ibaraki","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miyagi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Numakunai","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Osaka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Saitama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Daegu","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Progression free survival (PFS) by BICR assessment"],"hasResults":false,"conditionSlugs":["endometrial-cancer","als"],"drugSlugs":["pembrolizumab"],"locationSlugs":["toronto-canada","montreal-canada","fukuoka-japan","fukushima-japan","hokkaido-japan","ibaraki-japan","miyagi-japan","numakunai-japan","osaka-japan","saitama-japan","tokyo-japan","daegu-south-korea"],"enrichment":{"headline":"Phase 3: testing Mocertatug rezetecan for Neoplasms, Endometrial","inPlainEnglish":"This study wants to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care. The study will also assess whether the drug combination is safe and tolerated well by participants compared to standard of care and will help us better understand its impact on Health-Related Quality of Life of participants.","whoItsFor":["Ages 18 Years to any","Women only","Is able to commence C1D1 of study treatment within 3 - 9 weeks of the final dose of first-line therapy","Is deemed suitable to continue with maintenance therapy with immune checkpoint inhibition (dostarlimab or pembrolizumab)","Has histologically confirmed endometrial carcinoma including but not limited to endometrioid, serous, clear cell and endometrial carcinosarcoma. Mixed epithelial carcinomas are permitted","Meets one of the following criteria:","Has newly diagnosed stage III disease \\[2023 International Federation of Gynecology and Obstetrics (FIGO) staging\\] with measurable residual disease \\>1 cm after primary debulking surgery (incomplete cytoreduction)","Has newly diagnosed stage III disease (2023 FIGO staging) that is not suitable for primary debulking surgery with measurable disease","Has newly diagnosed stage IV disease (2023 FIGO staging) and any residual disease status (measurable or non-measurable) following debulking surgery. Participants not suitable for primary debulking surgery are also permitted"],"whoShouldSkip":["Mesenchymal tumors of the uterus (uterine sarcomas) and neuroendocrine uterine cancer","Has a malignancy (except disease under study) that has progressed or required active treatment within 36 months prior to date of randomization except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas","Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or non-infectious pneumonitis","Has had any major surgery within 28 days prior to date of C1D1 or received focal radiotherapy within 21 days prior to date of C1D1","Has received treatment with an investigational agent within 30 days prior to C1D1","Has received prior therapy with topoisomerase I inhibitors (e.g. irinotecan or topotecan) or Antibody-Drug Conjugate (ADC)with a topoisomerase I inhibitor warhead, B7-H4 targeted therapy, or immune checkpoint inhibitor","Has received treatment with inhibitors of P-glycoprotein (P-gp) or Breast cancer resistant protein (BCRP), or OATP1B1/1B3 transporterswithin 7 days prior to the date of C1D1. Inducers of P-gp should be discontinued for at least 14 days prior to the date of C1D1"],"whatHappens":"If you join, the listed intervention(s) are Mocertatug rezetecan, Dostarlimab, or Pembrolizumab. The registry lists allocation as randomized. This study wants to see how well mocertatug rezetecan (Mo-Rez) in combination with physician's choice of immunotherapy (dostarlimab or pembrolizumab) works as maintenance therapy in participants with advanced or recurrent endometrial cancer (EC) compared with the physician's choice of immunotherapy (dostarlimab or pembrolizumab) alone, which represents the current standard of care.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 610 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.700Z"},{"nctId":"NCT07685249","title":"Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment","officialTitle":"RESTORE-PC: Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment: A Randomized Feasibility Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.\n\nAll participants receive pelvic floor physical therapy and education about penile rehabilitation, including use of a vacuum erection device. Participants are randomly assigned to one of two groups. One group receives pelvic floor physical therapy plus telehealth sex therapy, with about ten sessions over six months. The other group receives pelvic floor physical therapy alone.\n\nParticipants complete questionnaires about urinary and sexual health at the start of the study and over the next two years. Short interviews are also done at 6 and 12 months. Medicines for erectile function are prescribed as part of usual clinical care and are not part of the study treatment.","conditions":["Prostate Cancer","Urinary Incontinence","Erectile Dysfunction"],"keywords":["Pelvic Floor Physical Therapy","Sex Therapy","Penile Rehabilitation"],"interventions":[{"type":"BEHAVIORAL","name":"Sex Therapy"},{"type":"BEHAVIORAL","name":"Pelvic Floor Physical Therapy"},{"type":"DEVICE","name":"Vacuum Erection Device (VED)"}],"enrollment":30,"startDate":"2026-11","completionDate":"2029-11","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Age 18 years or older.\n* Biopsy-confirmed localized prostate adenocarcinoma.\n* Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health.\n* Initiating pelvic floor physical therapy as part of routine clinical care.\n* Pre-treatment International Index of Erectile Function-5 (IIEF-5) score meeting the eligibility threshold, with or without aids, determined by medical record chart review (when documented within 4 months prior to index treatment) or collected post-treatment with participant recall anchored to the month prior to treatment. Eligibility threshold for the IIEF-5 is at or above 17.\n* Able to read and understand English to complete patient-reported outcome measures.\n* Ability to provide informed consent.\n\nExclusion Criteria\n\n* Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT.\n* Recieved non-nerve-sparing treatment (when applicable).\n* Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol.\n* Need for additional or secondary prostate cancer treatment during the intervention period.\n* Documented cognitive impairment or impairment that would interfere with participation.\n* Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment.\n* Inability to complete study video visits or questionnaires.\n* History of prior local or systemic treatment for prostate cancer","locations":[{"facility":"Duke University Medical Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael W Willis, BA","phone":"919-681-8437","email":"michael.w.willis@duke.edu"},{"name":"Smrithi Divakaran, MPH","phone":"919-681-7695","email":"smrithi.divakaran@duke.edu"}],"primaryOutcomes":["Recruitment feasibility as measured by number of participants recruited","Enrollment feasibility, as measured by consent rate","Randomization feasibility","Retention feasibility","Number of participants who complete study assessments","Number of participants who participate in pelvic floor physical therapy (PFPT)","Number of participants who participate in sex therapy","Number of participants who use recommended penile rehabilitation","Fidelity-monitoring feasibility"],"hasResults":false,"conditionSlugs":["prostate-cancer","als"],"drugSlugs":[],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Sex Therapy for Prostate Cancer","inPlainEnglish":"This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer. The goal is to see if it is feasible and acceptable to offer sex therapy by telehealth after prostate cancer treatment.","whoItsFor":["Ages 18 Years to any","Men only","Age 18 years or older","Biopsy-confirmed localized prostate adenocarcinoma","Treated with nerve-sparing radical prostatectomy, radiotherapy, or cryoablation as primary index therapy for prostate cancer at Duke Health","Initiating pelvic floor physical therapy as part of routine clinical care","Able to read and understand English to complete patient-reported outcome measures"],"whoShouldSkip":["Any androgen deprivation therapy (ADT) given for prostate cancer treatment or planned during the intervention or follow-up period, including neoadjuvant, concurrent, or adjuvant ADT","Recieved non-nerve-sparing treatment (when applicable)","Unable to engage in pelvic floor physical therapy or penile rehabilitation protocol","Need for additional or secondary prostate cancer treatment during the intervention period","Documented cognitive impairment or impairment that would interfere with participation","Major psychiatric concern that would interfere with ability to consent or participate, such as schizophrenia, based on the medical record or treating clinician assessment","Inability to complete study video visits or questionnaires"],"whatHappens":"If you join, the listed intervention(s) are Sex Therapy, Pelvic Floor Physical Therapy, or Vacuum Erection Device (VED). The registry lists allocation as randomized. This study is being done at Duke Health and includes adult men who have been treated for localized prostate cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Durham. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.318Z"},{"nctId":"NCT07685769","title":"A Study to Find Out if the Medicine Called Rimegepant is Safe for Adults in India","officialTitle":"AN OPEN-LABEL MULTICENTER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF RIMEGEPANT 75 MG ODT FOR ACUTE TREATMENT OF MIGRAINE IN ADULT PARTICIPANTS IN INDIA WITH PREVIOUS INSUFFICIENT RESPONSE TO TRIPTANS","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This is a multicenter, single-arm, open-label Phase 4 study evaluating the safety and tolerability of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.","conditions":["Acute Treatment of Migraine"],"keywords":["migraine","Rimegepant"],"interventions":[{"type":"DRUG","name":"Rimegepant 75 mg ODT"}],"enrollment":60,"startDate":"2026-07-24","completionDate":"2028-01-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nParticipants are eligible to be included in this study only if all of the following criteria apply:\n\nAge and Reproductive Status:\n\n1. 18 years of age or older who meet the reproductive criteria.\n\n   Disease Characteristics:\n2. Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:\n\n   1. At least 5 attacks fulfilling criteria 1-3:\n\n      1. Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated).\n      2. Headache has at least 2 of the following 4 characteristics:\n\n         * Unilateral location\n         * Pulsating quality\n         * Moderate or severe pain intensity\n         * Aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)\n      3. During headache, at least 1 of the following:\n\n         -Nausea and/or vomiting\n         * Photophobia and phonophobia\n   2. Not better accounted for by another ICHD-3 diagnosis.\n3. Participants experience 4-14 migraine days / month and fewer than 7 non-migraine headache days / month on average and overall, less than 15 days with headache (migraine or non-migraine) per month across the 3 months prior to screening.\n4. Participants on prophylactic migraine medication (non-CGRP) are permitted to remain on therapy if they have been on a stable dose for at least 3 months prior to screening visit, and the dose is not expected to change during the study.\n5. Participants have previous insufficient response and/or prior intolerance to at least one triptan or documented contraindication to the use of triptan.\n\n   1. Insufficient response - Previous treatment with one or more triptan has yielded no, unsatisfactory or inconsistent therapeutic effect (eg, recurrent, incomplete relief of migraine related symptoms \\[including pain, nausea, photophobia, phonophobia etc\\] at 2 hours post dose, non-sustained relief of migraine related symptoms through 24 hours post dose, etc), after repeated dosing (≥2 attempts) at recommended dose level.\n   2. Prior intolerance - treatment with triptan has been interrupted because of an adverse event that made continuation of the drug intolerable for the individual.\n\n      -Prior triptan associated overuse headache\n\n      -Arrhythmia associated with prior triptan use\n\n      -Chest/throat/neck/jaw pain, tightness, pressure or heaviness associated with prior use of triptan\n\n      -Gastrointestinal ischemia or peripheral vasospastic reaction associated with prior use of triptan\n      * Serotonin syndrome associated with prior triptan use\n   3. Documented contraindication to triptans -\n\n      1. Documented hypersensitivity to triptan\n      2. Cardiovascular events, conditions and procedures considered contraindications to the use of triptan medications.\n\n   i. Events: Myocardial infractions, prior cardiac arrest, transient ischemic attack, cerebrovascular accident (Intracerebral haemorrhage, intracranial haemorrhage, subarachnoid haemorrhage, ischemic stroke) ii. Conditions: Angina pectoris, coronary artery vasospasm, ischemic coronary artery disease, peripheral artery disease, ischemic bowel disease, cardiac conduction disorders (life threatening arrhythmia/heart block) iii. Procedure: Angioplasty, coronary artery bypass grafting, carotid endarterectomy 3) Uncontrolled hypertension\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\n\n   * PHQ-8 total score ≥15\n   * Suicidal ideation and behavior (one, or more, of the below is exclusionary):\n\n     * a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;\n     * suicidal ideation associated with actual intent and/or a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;\n     * any previous lifetime history of suicidal behavior: \"Yes\" to answer to any of the suicidal behavior items of the C-SSRS.\n   * Current diagnosis of schizophrenia, bipolar, or borderline personality disorder.\n   * History of severe drug allergy, including anaphylaxis or known hypersensitivity or intolerance to rimegepant or any of its excipients.\n2. Any of the following:\n\n   * History of any trigeminal autonomic cephalalgia (eg. cluster headache, Short-lasting, Unilateral, Neuralgiform headache attacks with Conjunctival injection and Tearing \\[SUNCT\\], Short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms \\[SUNA\\], hemicrania continua, paroxysmal hemicrania).\n   * Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome \\[CRPS\\]); Other pain syndromes (including trigeminal neuralgia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion, interfere with study assessments of safety.\n\n   Prior/Concomitant Therapy:\n3. Current use of any prohibited concomitant medication(s).\n4. History of use of ergotamine medications or triptans for greater than/equal to 10 days per month on a regular basis for greater than/equal to 3 months, or history of non-narcotic analgesic intake for greater than/equal to 15 days per month for greater than/equal to 3 months (eg, acetaminophen, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], gabapentin) for other pain indications.\n\n   Prior/Concurrent Clinical Study Experience:\n5. Participation in clinical trial with non-biological investigational agents or interventional treatments (last study visit occurring) within the 30 days or 5 half-lives of investigational drug (whichever is longer) prior to Baseline Visit. Participation in clinical trial with biological investigational agents (last study visit occurring) within 90 days or 5 half-lives (whichever is longer) prior to Baseline Visit. Participation in any other investigational clinical trial while participating in this clinical trial.\n\n   Diagnostic Assessments:\n6. ANY of the following findings at the Screening Visit and laboratory tests as assessed by the study-specific laboratory:\n\n   * eGFR (using CKD-EPI-Scr-Scys Combined) \\<30 mL/min/1.73m²\n   * Total bilirubin \\>1.5 × ULN (may be repeated once, with fractionation, for confirmation during the Screening Phase, and direct bilirubin \\>ULN is exclusionary if Gilbert's syndrome is suspected)\n   * AST (SGOT) or ALT (SGPT) \\>2.0 × ULN\n\n   Other Exclusion Criteria:\n7. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.","locations":[{"facility":"Visakha Institute Medical Sciences","city":"Visakhapatnam","state":"Andhra Pradesh","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Hospital","city":"Gurugram","state":"Haryana","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"BGS Global Institute of Medical Sciences","city":"Bangalore","state":"Karnataka","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mallikatta Neuro Centre","city":"Mangalore","state":"Karnataka","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chopda Medicare & Research Centre Pvt. Ltd: Magnum Heart Institute","city":"Nashik","state":"Maharashtra","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bhaktivedanta Hospital & Research Institute","city":"Thane","state":"Maharashtra","country":"India","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bangur Institute of Neurosciences, IPGME&R - SSKM Hospital","city":"Kolkata","state":"West Bengal","country":"India","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Incidence of Treatment-emergent adverse events (TEAEs)","Incidence of Serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["visakhapatnam-india","gurugram-india","bangalore-india","mangalore-india","nashik-india","thane-india","kolkata-india"],"enrichment":{"headline":"Phase 4: testing Rimegepant 75 mg ODT for Acute Treatment of Migraine","inPlainEnglish":"This is a multicenter, single-arm, open-label Phase 4 study evaluating the whether it is safe and how hard side effects are to live with of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans. It will enroll approximately 60 participants.","whoItsFor":["Ages 18 Years to any","Participants are eligible to be included in this study only if all of the following criteria apply:","Age and Reproductive Status:","18 years of age or older who meet the reproductive criteria","Disease Characteristics:","Participant has at least a 1-year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:","At least 5 attacks fulfilling criteria 1-3:","Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated)"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Medical Conditions:","PHQ-8 total score ≥15","Suicidal ideation and behavior (one, or more, of the below is exclusionary):","a positive response to item 1 or 2 of the C-SSRS within 30 days prior to Screening;","suicidal ideation associated with actual intent and/or a method or plan at any time in their lifetime: any positive response on items 3, 4 or 5 of the C-SSRS;","any previous lifetime history of suicidal behavior: \"Yes\" to answer to any of the suicidal behavior items of the C-SSRS"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant 75 mg ODT. The registry lists allocation as na. This is a multicenter, single-arm, open-label Phase 4 study evaluating the whether it is safe and how hard side effects are to live with of rimegepant 75 mg orally disintegrating tablet (ODT) for the acute treatment of migraine (with or without aura) in adult patients in India who have had an insufficient response, intolerance, or contraindication to triptans.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 60 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.304Z"},{"nctId":"NCT07685808","title":"Study of Olatorepatide in Adult Participants Living With Overweight or Obesity Without Diabetes","officialTitle":"A Phase 2, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Efficacy of Olatorepatide, a GLP-1/GIP Receptor Agonist, With Different Doses and Drug-Titration Algorithms in Participants Living With Overweight or Obesity","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test an experimental drug called olatorepatide (\"study drug\") to determine how safe and effective this drug is compared to placebo and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.\n\nThe study is looking at:\n\n* What side effects the study drug might cause\n* How much study drug is in the blood at different times\n* How well the study drug works\n* What effects the study drug may have on the body at different dosing schedules\n* If the body makes antibodies to the study drug as this may cause the study drug to not work as well","conditions":["Overweight or Obesity"],"keywords":["Body weight","Glucagon-Like Peptide-1 (GLP-1)/Gastric inhibitory polypeptide (GIP) receptor agonist","Dose-finding","Control appetite"],"interventions":[{"type":"DRUG","name":"Olatorepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":360,"startDate":"2026-07-28","completionDate":"2028-01-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Body Mass Index (BMI) ≥30.0 kg/m\\^2 to \\<45.0 kg/m\\^2 at screening OR\n2. BMI ≥27.0 kg/m\\^2 at screening with at least 1 of the following weight-related co-morbidities: Hypertension, Dyslipidemia, Prediabetes, established Obstructive Sleep Apnea (OSA), established Coronary Artery Disease (CAD), Heart failure, established cerebrovascular disease as described in the protocol\n\nKey Exclusion Criteria:\n\n1. Previous or current diagnosis of Type 1 or Type 2 diabetes at screening\n2. Change in body weight \\>5 kg within approximately 3 months before screening as described in the protocol\n3. Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol\n4. History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones\n5. History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n\nNote: Other Protocol Defined Inclusion/ Exclusion Criteria Apply","locations":[{"facility":"AMR Clinical - Mobile","city":"Mobile","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research - Flourish Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chase Medical Research","city":"Waterbury","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance for Multispecialty Research (AMR) Clinical Miami","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Fort Myers","city":"Fort Myers","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AGA Clinical Trials","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research, Nature Coast Clinical Research","city":"Inverness","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research, Jacksonville Center for Clinical Research","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research Maitland LLC, Main Office","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The IMA Group, IMA Clinical Research St. Petersburg","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research LLC - The Villages","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site Partners, LLC DBA Flourish Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research LLC - Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research, Ravenswood Rheumatology","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Chicago Oak Brook","city":"Oak Brook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical Wichita","city":"Wichita","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical - Lexington","city":"Lexington","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Omaha","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYC Research Inc","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tribe Clinical Research","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Occurrence of Treatment-Emergent Adverse Events (TEAEs)","Severity of TEAEs","Percent change in body weight"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["mobile-alabama","walnut-creek-california","waterbury-connecticut","doral-florida","fort-myers-florida","hialeah-florida","inverness-florida","jacksonville-florida","maitland-florida","st-petersburg-florida","the-villages-florida","winter-park-florida","chicago-illinois","oak-brook-illinois","wichita-kansas","lexington-kentucky","omaha-nebraska","new-york-new-york","rochester-new-york","greenville-south-carolina"],"enrichment":{"headline":"Phase 2: testing Olatorepatide for Overweight or Obesity","inPlainEnglish":"This study will test an experimental drug called olatorepatide (\"study drug\") to determine how safe and effective this drug is compared to dummy treatment (placebo) and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes. The study is looking at: * What side effects the study drug might cause * How much study drug is in the blood at different times * How well the study drug works * What effects the study drug may have on the body at different dosing schedules * If the body makes antibodies to the study drug as this may cause the study drug to not work as well","whoItsFor":["Ages 18 Years to any","Body Mass Index (body-mass index (BMI)) ≥30.0 kg/m\\^2 to \\<45.0 kg/m\\^2 at screening OR"],"whoShouldSkip":["Previous or current diagnosis of Type 1 or Type 2 diabetes at screening","Change in body weight \\>5 kg within approximately 3 months before screening as described in the protocol","Bariatric surgery, including any procedures to revise, reverse, or remove any previous bariatric surgery interventions as described in the protocol","History of acute or chronic pancreatitis, cholecystitis, or symptomatic gallbladder stones","History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2","Note: Other Protocol Defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Olatorepatide, or Placebo. The registry lists allocation as randomized. This study will test an experimental drug called olatorepatide (\"study drug\") to determine how safe and effective this drug is compared to dummy treatment (placebo) and how easily the body can accept this drug at different doses and dosing schedules without causing side effects, as well as how the drug is processed in the body by participants with overweight or obesity but do not have diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 360 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.837Z"},{"nctId":"NCT07686263","title":"Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia","officialTitle":"A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Karuna Therapeutics, Inc., a Bristol Myers Squibb company","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia","conditions":["Schizophrenia"],"keywords":["KarXT","Cobenfy"],"interventions":[{"type":"DRUG","name":"Xanomeline/Trospium Chloride"},{"type":"DRUG","name":"Placebo"}],"enrollment":472,"startDate":"2026-08-20","completionDate":"2029-03-03","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.\n* Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.\n* Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.\n* Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:\n\n  1. Item 1 (P1; delusions)\n  2. Item 2 (P2; conceptual disorganization)\n  3. Item 3 (P3; hallucinatory behavior)\n  4. Item 6 (P6; suspiciousness/persecution)\n* Participant must have a CGI-S score of ≥ 4 at screening and Day -1\n* Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.\n\nExclusion Criteria\n\n* Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening\n* Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.\n* Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).\n* Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.\n* Participant must not have a history of treatment resistance to schizophrenia medications\n* Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.\n* Other protocol-defined Inclusion/Exclusion criteria apply.","locations":[{"facility":"Pillar Clinical Research - Bentonville","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pillar Clinical Research- Little Rock","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0021","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0153","city":"Rogers","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0190","city":"Anaheim","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Innovations, Inc. dba CITrials","city":"Bellflower","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0032","city":"Culver City","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Research, LLC","city":"Garden Grove","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0068","city":"La Habra","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0128","city":"Lemon Grove","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0187","city":"Montclair","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NRC Research Institute","city":"Orange","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0030","city":"Pico Rivera","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0185","city":"Redlands","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0186","city":"Riverside","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 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0191","city":"Novi Iskar","state":"","country":"Bulgaria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0162","city":"Brno","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0014","city":"Klecany","state":"","country":"Czechia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0123","city":"Warsaw","state":"Masovian Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0122","city":"Bialystok","state":"Podlaskie Voivodeship","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0001","city":"Poznan","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0104","city":"Brașov","state":"Brăila County","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0103","city":"Bucharest","state":"Bucharest","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0105","city":"Bucharest","state":"Bucharest","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0107","city":"Bucharest","state":"Bucharest","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0110","city":"Bucharest","state":"Bucharest","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0174","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0106","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0109","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0112","city":"Barcelona","state":"Barcelona [Barcelona]","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0167","city":"Valladolid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - 0181","city":"Zamora","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"BMS Clinical Trials Contact Center www.BMSClinicalTrials.com","phone":"855-907-3286","email":"Clinical.Trials@bms.com"},{"name":"First line of the email MUST contain NCT # and Site #.","phone":"","email":""}],"primaryOutcomes":["Time From Randomization to the First Relapse Event"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["bentonville-arkansas","little-rock-arkansas","rogers-arkansas","anaheim-california","bellflower-california","culver-city-california","garden-grove-california","la-habra-california","lemon-grove-california","montclair-california","orange-california","pico-rivera-california","redlands-california","riverside-california","torrance-california","boynton-beach-florida","hollywood-florida","miami-florida","miami-lakes-florida","miami-springs-florida","oakland-park-florida","atlanta-georgia","sandy-springs-georgia","savannah-georgia","chicago-illinois","gaithersburg-maryland","cincinnati-ohio","oklahoma-city-oklahoma","austin-texas","richardson-texas","r-o-cuarto-argentina","buenos-aires-argentina","c-rdoba-argentina","santiago-del-estero-argentina","novi-iskar-bulgaria","brno-czechia","klecany-czechia","warsaw-poland","bialystok-poland","poznan-poland","bra-ov-romania","bucharest-romania","barcelona-spain","valladolid-spain","zamora-spain"],"enrichment":{"headline":"Phase 3: testing Xanomeline/Trospium Chloride for Schizophrenia","inPlainEnglish":"The purpose of the study is to measure the relapse prevention of KarXT in the treatment of participants with Schizophrenia","whoItsFor":["Ages 18 Years to 65 Years","Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date","Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1","Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:","Item 1 (P1; delusions)","Item 2 (P2; conceptual disorganization)","Item 3 (P3; hallucinatory behavior)","Item 6 (P6; suspiciousness/persecution)"],"whoShouldSkip":["Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening","Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia","Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS)","Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening","Participant must not have a history of treatment resistance to schizophrenia medications","Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%","Other protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Xanomeline/Trospium Chloride, or Placebo. The registry lists allocation as randomized. The purpose of the study is to measure the relapse prevention of KarXT in the treatment of participants with Schizophrenia","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 472 people at 54 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.044Z"},{"nctId":"NCT07686354","title":"LIFU for Chronic Pain and Generalized Anxiety Disorder","officialTitle":"Accelerated Low-Intensity Focused Ultrasound (LIFU) for Chronic Pain and Generalized Anxiety Disorder: A Proof-of-Concept Case Series","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Virginia Polytechnic Institute and State University","sponsorClass":"OTHER","summary":"A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.","conditions":["Chronic Pain","Generalized Anxiety Disorder"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Low Intensity Focused Ultrasound"}],"enrollment":10,"startDate":"2026-12","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* GAD Symptoms - GAD-7 score \\>= 10, OASIS score \\>= 8, or PSWQ score \\>= 45. OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months.\n\nExclusion Criteria:\n\n* Claustrophobia\n* Contraindications to MRI or CT\n* Active medical disorder with CNS effects\n* History of neurologic disorder\n* History of head injury with LOC \\> 10 minutes\n* Active drug or alcohol dependence","locations":[{"facility":"Fralin Biomedical Research Institute at VTC","city":"Roanoke","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica Research Associate, MPH","phone":"540-526-2261","email":"jnw@vtc.vt.edu"}],"primaryOutcomes":["Safety - monitoring of possible symptoms","Changes in Chronic Pain - self report","Changes in Anxiety - self report"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["roanoke-virginia"],"enrichment":{"headline":"Not a traditional drug phase: Low Intensity Focused Ultrasound for Chronic Pain","inPlainEnglish":"A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.","whoItsFor":["Ages 18 Years to 65 Years","GAD Symptoms - GAD-7 score \\>= 10, OASIS score \\>= 8, or PSWQ score \\>= 45. OR Chronic pain symptoms - moderate to severe pain, present for at least 3 months"],"whoShouldSkip":["Contraindications to MRI or CT","Active medical disorder with CNS effects","History of neurologic disorder","History of head injury with LOC \\> 10 minutes","Active drug or alcohol dependence"],"whatHappens":"If you join, the listed intervention(s) are Low Intensity Focused Ultrasound. The registry lists allocation as na. A proof of concept case study to investigate accelerated LIFU protocol in chronic pain and anxiety populations.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Roanoke. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.342Z"},{"nctId":"NCT07686783","title":"Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts","officialTitle":"Ovarian Reserve After Laparoscopic Cystectomy for Endometriotic and Non-Endometriotic Cysts: A Comparative Prospective Cohort Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Benha University","sponsorClass":"OTHER","summary":"We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.","conditions":["Ovarian Cysts","Endometriosis","Benign Ovarian Cyst","Ovarian Reserve","Cystectomy"],"keywords":["Laparoscopy","Cystectomy","Endometriotic Ovarian Cysts","Benign Ovarian Cysts","Ovarian Reserve Markers"],"interventions":[{"type":"PROCEDURE","name":"Laparoscopic Ovarian Cystectomy"}],"enrollment":60,"startDate":"2026-06-30","completionDate":"2027-06","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female patients aged 18-45 years\n* Ovarian cyst measuring 6-15 cm in diameter, confirmed by transvaginal ultrasound or MRI\n* Cyst is persistent for more than 3 months if asymptomatic, OR any symptomatic cyst regardless of duration of diagnosis\n* Serum anti-Müllerian hormone (AMH) level ≥ 2 ng/mL, measured within 1 month preoperatively\n* Willingness to participate and provide written informed consent\n\nExclusion Criteria:\n\n* Clinical or ultrasonic suspicion of ovarian malignancy\n* Ovarian cyst associated with pregnancy\n* Previous history of ovarian surgery\n* History of pelvic irradiation or chemotherapy\n* Known endocrine disorders affecting ovarian function (e.g., PCOS, premature ovarian insufficiency, thyroid dysfunction, hyperprolactinemia)\n* Current use of hormonal contraceptives or hormonal therapy within 3 months prior to enrollment\n* Presence of severe systemic disease that contraindicates surgery or general anesthesia\n* Refusal to participate or inability to provide informed consent","locations":[{"facility":"Benha Univesity Hospital","city":"Banhā","state":"Qalyubia Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AHMED ALNEZAMY, MD","phone":"01224849065","email":"AHMED.ALNZAMY@fmed.bu.edu.eg"}],"primaryOutcomes":["Absolute Change in Serum Anti-Müllerian Hormone (AMH) Level"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["banh-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Laparoscopic Ovarian Cystectomy for Ovarian Cysts","inPlainEnglish":"We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Female patients aged 18-45 years","Ovarian cyst measuring 6-15 cm in diameter, confirmed by transvaginal ultrasound or MRI","Cyst is persistent for more than 3 months if asymptomatic, OR any symptomatic cyst regardless of duration of diagnosis","Serum anti-Müllerian hormone (AMH) level ≥ 2 ng/mL, measured within 1 month preoperatively"],"whoShouldSkip":["Clinical or ultrasonic suspicion of ovarian malignancy","Ovarian cyst associated with pregnancy","Previous history of ovarian surgery","History of pelvic irradiation or chemotherapy","Known endocrine disorders affecting ovarian function (e.g., PCOS, premature ovarian insufficiency, thyroid dysfunction, hyperprolactinemia)","Current use of hormonal contraceptives or hormonal therapy within 3 months prior to enrollment","Presence of severe systemic disease that contraindicates surgery or general anesthesia"],"whatHappens":"If you join, the listed intervention(s) are Laparoscopic Ovarian Cystectomy. The registry lists allocation as randomized. We will conduct this study to estimate the effect of laparoscopic cystectomy on ovarian reserve in endometriotic cysts versus non-endometriotic cysts.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Banhā. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.113Z"},{"nctId":"NCT07688044","title":"The Role That Food and Bacteria Play in Generating Abdominal Pain","officialTitle":"The Role of Gut Microbiota in Patient Responses to a Dietary Therapy for Abdominal Pain","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"David Reed","sponsorClass":"OTHER","summary":"Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat. Our research will explore how a type of dietary carbohydrate, called FODMAPS, contributes to chronic abdominal pain in irritable bowel syndrome (IBS). FODMAPs, are poorly digested carbohydrates and removing FODMAPs from the diet relieves abdominal pain in approximately half of IBS patients. Unfortunately, FODMAPs are contained in many foods, which makes it challenging for patients to remain on a low FODMAP diet for extended periods. Our proposed research will identify which subtypes of FODMAPs are most responsible for increasing pain and will tease apart whether the pain-causing effects of FODMAPs rely on the gut microbiota or not. To identify which specific type of FODMAP causes pain, IBS patients will adopt a low FODMAP diet and then individual FODMAP subtypes will be added back to their diet while monitoring changes to their pain. Stool samples will be collected from the participants to determine whether the composition of the gut microbiota or the chemicals that it produces are changed when symptoms are improved or exacerbated by manipulating FODMAP availability. In parallel studies, the microbiota of each IBS patient will be grown in specialized conditions to mimic the environment of the gut. These patient microbial communities will be exposed to the same FODMAP manipulations as the patients themselves experience. This will allow us to test whether the changes in gut microbiota composition and the chemicals produced that occur in IBS patients in response to FODMAP manipulations also occur when only the microbiota is exposed to these manipulations. Together, these studies will aim to optimize a dietary therapy for a common chronic pain condition and will provide novel insights into how diet affects the chemicals the gut microbiota produces that contribute to abdominal pain.","conditions":["Irritable Bowel Syndrome (IBS)"],"keywords":["FODMAPs","Microbiota","Neuroactive mediators","Abdominal pain","GI pain signaling"],"interventions":[{"type":"OTHER","name":"FODMAP Challenge"}],"enrollment":60,"startDate":"2026-03-16","completionDate":"2030-03","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18-70 with IBS (Rome IV (now V) criteria)\n* PROMIS belly pain score \\>12\n\nExclusion Criteria:\n\n1. Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS.\n2. Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.\n3. Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS.\n4. Body mass index above 35 kg/m2 as it is unknown how mediators in the GI tract that may be involved in pain signaling in the gut are affected by obesity.\n5. History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract.\n6. Pregnant or breastfeeding women.\n7. Active or recent participation (\\< 1 month) in a clinical study.\n8. Use of antibiotics, probiotics, during, or one month prior to the study as may affect gut microbiota.\n9. Use of new medications less than 4 weeks prior to the study as may alter gut microbiota and/or IBS symptoms.\n10. Allergies to any of the ingredients used in the study.\n11. Any immune-compromising conditions as may affect GI symptoms.\n12. Currently being treated for eating disorder, schizophrenia, psychosis or other acute mental disorders as participating in a diet challenge study may have negative impact on these disorders.","locations":[{"facility":"Hotel Dieu Hospital","city":"Kingston","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in Dorsal Root Ganglion (DRG) neuron rheobase by chemostat supernatant","Change in Dorsal Root Ganglion (DRG) neuron rheobase by fecal supernatant"],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["kingston-canada"],"enrichment":{"headline":"Not a traditional drug phase: FODMAP Challenge for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat. Our research will explore how a type of dietary carbohydrate, called FODMAPS, contributes to chronic abdominal pain in irritable bowel syndrome (IBS).","whoItsFor":["Ages 18 Years to 70 Years","Adults aged 18-70 with IBS (Rome IV (now V) criteria)","PROMIS belly pain score \\>12"],"whoShouldSkip":["Concurrent significant organic GI pathology (i.e. celiac, IBD, etc.) as some symptoms may be related to their disease and not IBS","Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection","Major gastrointestinal surgery (e.g. Roux en y, bowel resection) as symptoms may be related to previous surgery rather than IBS","Body mass index above 35 kg/m2 as it is unknown how mediators in the GI tract that may be involved in pain signaling in the gut are affected by obesity","History of active cancer in the last 5 years, other than basal cell cancer as the treatment may have impacted the GI tract","Pregnant or breastfeeding women","Active or recent participation (\\< 1 month) in a clinical study"],"whatHappens":"If you join, the listed intervention(s) are FODMAP Challenge. The registry lists allocation as na. Irritable Bowel Syndrom (IBS) affects up to five percent of Canadians and has proven difficult to treat.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Kingston. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.444Z"},{"nctId":"NCT07688213","title":"A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease","officialTitle":"A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"This is a randomized, placebo-controlled Phase 2 study to evaluate the efficacy and safety of SAR448851 in early Alzheimer's disease (AD) participants. The purpose of this study is to measure efficacy and safety with once daily oral SAR448851 compared to placebo in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.\n\nThis Phase 2 study has 2 parts: Part A is a randomized, double-blind, parallel-group, placebo-controlled study with SAR448851 oral once daily. Part B is an open-label extension. All participants who complete Part A may continue to Part B. An optional dose 2 cohort will be considered to evaluate the efficacy and safety of SAR448851 dose 2 oral once daily.\n\nThe study duration will be up to 111 weeks for Part A and B, and up to 63 weeks for the dose 2 cohort. The treatment duration will be up to 96 weeks for Part A and B, and up to 48 weeks for the dose 2 cohort.\n\nUp to 160 participants will be included in this study.","conditions":["Dementia, Alzheimer's Type","Alzheimer's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"SAR448851"},{"type":"DRUG","name":"Placebo"}],"enrollment":160,"startDate":"2026-07-28","completionDate":"2029-07-31","sex":"ALL","minAge":"55 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.\n* Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \\[NIA-AA\\] Stage 3) or mild AD dementia (NIA-AA Stage 4).\n* Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.\n* Have a study partner who must provide separate written informed consent at screening. Study partner should be \\>18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.\n* The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening.\n\nExclusion Criteria:\n\n* The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).\n* The participant has evidence of more than 4 microhemorrhages (\\<10 mm in diameter) or superficial siderosis.\n* The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).\n* The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.\n* The participant is currently receiving anticoagulant therapies.\n* The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","locations":[{"facility":"Healthy Brain Clinic- Site Number : 8400011","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oakland Clinical- Site Number : 8400010","city":"Oakland","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aqualane Clinical Research- Site Number : 8400001","city":"Naples","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Orlando - South Orlando Avenue- Site Number : 8400008","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alzheimer's Research and Treatment Center - Stuart, FL- Site Number : 8400014","city":"Stuart","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Brain Health- Site Number : 8400019","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - Lady Lake- Site Number : 8400004","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alzheimer's Research and Treatment Center - Wellington- Site Number : 8400012","city":"Wellington","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Center for Memory - Newton- Site Number : 8400007","city":"Newton","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Cognitive and Research Center of New Jersey - Springfield- Site Number : 8400005","city":"Springfield","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summit Research Network - Portland - Northwest Vaughn Street- Site Number : 8400002","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research - Keystone Clinical Studies- Site Number : 8400003","city":"Plymouth Meeting","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rhode Island Mood & Memory Research Institute- Site Number : 8400015","city":"East Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kerwin Medical Center- Site Number : 8400006","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360001","city":"Macquarie Park","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360003","city":"Ivanhoe","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 0360004","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240001","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240005","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1240008","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 1560001","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760003","city":"Berlin","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 2760002","city":"Cologne","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240008","city":"Barcelona","state":"Barcelona [Barcelona]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240006","city":"Barcelona","state":"Barcelona [Barcelona]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240004","city":"Barcelona","state":"Catalunya [Cataluña]","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240003","city":"Pozuelo de Alarcón","state":"Madrid","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240001","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240005","city":"Zaragoza","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260002","city":"London","state":"Hammersmith and Fulham","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260001","city":"London","state":"London, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 8260004","city":"Bath","state":"Somerset","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217","Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["long-beach-california","oakland-california","naples-florida","orlando-florida","stuart-florida","tampa-florida","the-villages-florida","wellington-florida","newton-massachusetts","springfield-new-jersey","portland-oregon","plymouth-meeting-pennsylvania","east-providence-rhode-island","dallas-texas","macquarie-park-australia","ivanhoe-australia","melbourne-australia","ottawa-canada","toronto-canada","montreal-canada","beijing-china","berlin-germany","cologne-germany","barcelona-spain","pozuelo-de-alarc-n-spain","valencia-spain","zaragoza-spain","london-united-kingdom","bath-united-kingdom"],"enrichment":{"headline":"Phase 2: testing SAR448851 for Dementia, Alzheimer's Type","inPlainEnglish":"This is a randomly assigned, compared with a dummy treatment Phase 2 study to measure the how well it works and safety of SAR448851 in early Alzheimer's disease (AD) participants. this study wants to measure how well it works and safety with once daily oral SAR448851 compared to dummy treatment (placebo) in participants with mild cognitive impairment due to AD or mild AD dementia and with evidence of cerebral amyloid pathology.","whoItsFor":["Ages 55 Years to 85 Years","Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association \\[NIA-AA\\] Stage 3) or mild AD dementia (NIA-AA Stage 4)","Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening","The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening"],"whoShouldSkip":["The participant has evidence of more than 4 microhemorrhages (\\<10 mm in diameter) or superficial siderosis","The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4)","The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy","The participant is currently receiving anticoagulant therapies","The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial"],"whatHappens":"If you join, the listed intervention(s) are SAR448851, or Placebo. The registry lists allocation as randomized. This is a randomly assigned, compared with a dummy treatment Phase 2 study to measure the how well it works and safety of SAR448851 in early Alzheimer's disease (AD) participants.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at 32 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.325Z"},{"nctId":"NCT07688460","title":"Evaluation System for Lecanemab Efficacy Using Gold Electrode ECL to Monitor Alzheimer's Biomarkers","officialTitle":"Construction of a Lecanemab Therapeutic Efficacy Evaluation System Based on Mesoporous Gold Electrode Surface-enhanced Electrochemiluminescence for Monitoring Dynamic Changes of Alzheimer's Disease Plasma Biomarkers","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The Fourth Affiliated Hospital of Zhejiang University School of Medicine","sponsorClass":"OTHER","summary":"This study aims to evaluate the therapeutic efficacy of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma. By tracking changes in these biomarkers, the study seeks to determine how effectively Lecanemab treats the disease and to validate this new ECL-based monitoring system as a useful tool for clinical assessment.","conditions":["Alzheimer Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Lecanemab"}],"enrollment":100,"startDate":"2026-07-10","completionDate":"2029-03-30","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia.\n2. Age between 50 and 90 years (inclusive).\n3. Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers).\n4. Mini-Mental State Examination (MMSE) score between 22 and 30.\n5. Clinical Dementia Rating (CDR) global score of 0.5 or 1.\n6. Stable dose of allowed concomitant medications for at least 4 weeks prior to screening.\n7. Willing and able to comply with the study procedures, including blood draws for ECL monitoring.\n8. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease).\n2. History of brain hemorrhage, microbleeds, or superficial siderosis on MRI.\n3. Use of anticoagulants that cannot be safely interrupted.\n4. Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study.\n5. Known hypersensitivity to Lecanemab or any excipients.\n6. Pregnant or breastfeeding women.\n7. Participation in another interventional clinical trial within the last 30 days.","locations":[{"facility":"The First Affiliated Hospital, Zhejiang University School of Medicine","city":"Yiwu","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xuhua Xu","phone":"+8613705790560","email":"fupinglangying@zju.edu.cn"}],"primaryOutcomes":["Change in Plasma Alzheimer's Biomarkers"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["yiwu-china"],"enrichment":{"headline":"Phase 4: testing Lecanemab for Alzheimer Disease","inPlainEnglish":"This study aims to measure the therapeutic how well it works of Lecanemab in patients with Alzheimer's disease. The researchers will use a novel detection method based on mesoporous gold electrode surface-enhanced electrochemiluminescence (ECL) to monitor specific biomarkers in the patients' plasma.","whoItsFor":["Ages 50 Years to 90 Years","Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia","Age between 50 and 90 years (inclusive)","Confirmed presence of amyloid pathology (positive amyloid PET scan or CSF biomarkers)","Mini-Mental State Examination (MMSE) score between 22 and 30","Clinical Dementia Rating (CDR) global score of 0.5 or 1","Stable dose of allowed concomitant medications for at least 4 weeks prior to screening","Willing and able to comply with the study procedures, including blood draws for ECL monitoring"],"whoShouldSkip":["Significant neurological disorders other than Alzheimer's disease (e.g., stroke, Parkinson's disease)","History of brain hemorrhage, microbleeds, or superficial siderosis on MRI","Use of anticoagulants that cannot be safely interrupted","Severe systemic diseases (e.g., severe heart failure, uncontrolled diabetes) that may interfere with the study","Known hypersensitivity to Lecanemab or any excipients","Pregnant or breastfeeding women","Participation in another treatment clinical trial within the last 30 days"],"whatHappens":"If you join, the listed intervention(s) are Lecanemab. The registry lists allocation as na. This study aims to measure the therapeutic how well it works of Lecanemab in patients with Alzheimer's disease.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 100 people at Yiwu. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.231Z"},{"nctId":"NCT07691970","title":"Rollover Study for Participants Who Have Completed a Previous Clinical Study With Anifrolumab (Saphnelo) and Clinically Benefited From Continued Treatment","officialTitle":"ROSY-S: Rollover Study for Participants Who Have Completed a Previous Study With Anifrolumab (Saphnelo) and Are Assessed by the Investigator to Clinically Benefit From Continued Treatment","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring safety and tolerability.\n\nStudy details include:\n\n* Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study. Participants with a treatment gap from parent studies and/or who are on compassionate use are eligible to rollover to ROSY-S study.\n* The earliest that the Enrolment Visit may occur is at the time of the last visit of the parent study (ie, completion of the parent study's final safety follow-up visit). All required assessments from the safety follow-up visit of the parent study must be completed before the Enrolment Visit of ROSY-S study.\n* The participants will continue to receive anifrolumab the same way they received it in the parent trial\n* A participant is considered to have completed the study when they meet one of the discontinuation criteria.\n* Safety will be monitored throughout the study. Both serious and nonserious AEs will be collected up to 12 weeks after the last dose of anifrolumab and will be reported as part of the primary safety endpoint.","conditions":["Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Anifrolumab"},{"type":"COMBINATION_PRODUCT","name":"Anifrolumab"},{"type":"DRUG","name":"Anifrolumab"}],"enrollment":1072,"startDate":"2026-08-31","completionDate":"2032-12-30","sex":"ALL","minAge":"5 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants are eligible to be included in the study only if all of the following criteria apply:\n\n  1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study.\n* In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk.\n* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Participants should continue following the contraception requirements as per Appendix B from study enrolment up to 16 weeks after the last dose of study treatment.\n* Capable of giving signed informed consent described in Appendix A which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.\n* Capable of adhering to the treatment plan related to this ROSY-S study.\n\nExclusion Criteria:\n\n* Participant develops hypersensitivity to any of the components of anifrolumab.\n* Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study.\n* Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer.\n* Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab.\n* Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF.\n* Participants who are planning to use live/live-attenuated vaccines.\n* Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator.\n* Participants with any medical condition (such as cancer or viral infections \\[hepatitis\\]) or psychiatric condition that, in the opinion of the Investigator, could jeopardise or would compromise the participant's ability to participate in this study as determined by the Investigator based on protocol required assessments.\n* Participants who discontinued the parent study prior to completion of all study visits.\n* Local access to approved and commercially available (reimbursed) drug for the defined indication as permitted by local/country regulation.","locations":[{"facility":"Research Site","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Irvine","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fort Lauderdale","state":"Florida","country":"United 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Yai","state":"","country":"Thailand","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Khon Kaen","state":"","country":"Thailand","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Klong Luang","state":"","country":"Thailand","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fatih-Istanbul","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ümraniye","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cambridge","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Leeds","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Newcastle upon Tyne","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sheffield","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hà Nội","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"+1877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["SAEs and Non-Serious AEs"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","irvine-california","los-angeles-california","san-francisco-california","boca-raton-florida","fort-lauderdale-florida","chicago-illinois","indianapolis-indiana","baltimore-maryland","boston-massachusetts","ann-arbor-michigan","rochester-minnesota","omaha-nebraska","new-york-new-york","charlotte-north-carolina","cleveland-ohio","columbus-ohio","portland-oregon","charleston-south-carolina","dallas-texas","roanoke-virginia","quilmes-argentina","san-miguel-argentina","melbourne-australia","mitcham-australia","westmead-australia","graz-austria","linz-austria","vienna-austria","ghent-belgium","leuven-belgium","belo-horizonte-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","salvador-brazil","s-o-paulo-brazil","haskovo-bulgaria","plovdiv-bulgaria","sofia-bulgaria","toronto-canada","qu-bec-canada","santiago-chile","beijing-china","chongqing-china","guangzhou-china","jinan-china","lanzhou-china","shanghai-china","shenzhen-china","bogot-colombia","prague-czechia","bordeaux-france","nantes-france","paris-france","poitiers-france","rennes-france","strasbourg-france","toulouse-france","berlin-germany","dresden-germany","essen-germany","freiburg-im-breisgau-germany","hanover-germany","kiel-germany","mainz-germany","marburg-germany","m-nster-germany","regensburg-germany","t-bingen-germany","wuppertal-germany","cha-d-ri-greece","hyderabad-india","kolkata-india","new-delhi-india","pune-india","haifa-israel","kfar-saba-israel","brescia-italy","catania-italy","cona-italy","florence-italy","milan-italy","naples-italy","pavia-italy","roma-italy","fukuoka-japan","kanazawa-japan","maebashi-japan","nagoya-japan","sapporo-japan","yokohama-japan","guadalajara-mexico","m-xico-mexico","san-luis-potos-city-mexico","veracruz-mexico","rotterdam-netherlands","iloilo-city-philippines","lipa-city-philippines","manila-philippines","bydgoszcz-poland","katowice-poland","kielce-poland","krakow-poland","lodz-poland","ossy-poland","warsaw-poland","braga-portugal","lisbon-portugal","porto-portugal","bucharest-romania","cluj-napoca-romania","ia-i-romania","belgrade-serbia","kragujevac-serbia","ko-ice-slovakia","pie-any-slovakia","johannesburg-south-africa","seoul-south-korea","a-coru-a-spain","barcelona-spain","castellon-spain","granada-spain","las-palmas-de-gran-canaria-spain","madrid-spain","valencia-spain","valladolid-spain","vigo-spain","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","bangkok-thailand","hat-yai-thailand","khon-kaen-thailand","klong-luang-thailand","fatih-istanbul-turkey-t-rkiye","mraniye-turkey-t-rkiye","cambridge-united-kingdom","leeds-united-kingdom","london-united-kingdom","newcastle-upon-tyne-united-kingdom","sheffield-united-kingdom","h-n-i-vietnam"],"enrichment":{"headline":"Phase 3: testing Anifrolumab for Systemic Sclerosis Cutaneous Lupus E Myopathies Systemic Lupus Erythematosus","inPlainEnglish":"This study wants to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring whether it is safe and how hard side effects are to live with. Study details include: * Participants can transition in ROSY-S once they complete their participation in the parent study and should have received at least one dose of anifrolumab in the parent study.","whoItsFor":["Ages 5 Years to 80 Years","Participants are eligible to be included in the study only if all of the following criteria apply:","1 Participants must have completed the entirety of the parent study and should have received at least one dose of anifrolumab in the parent study","In the opinion of the Investigator, the potential benefit to the participant of continuing anifrolumab at the end of the parent study outweighs the risk","Capable of adhering to the treatment plan related to this ROSY-S study"],"whoShouldSkip":["Participant develops hypersensitivity to any of the components of anifrolumab","Female participant who is breastfeeding, pregnant, or intends to become pregnant during participation in this study","Currently participating in any investigational study or participated in an investigational study within 30 days prior to enrolment or within 5 half-lives of the investigational medicinal product (other than the parent study for anifrolumab) whichever is longer","Ongoing, unresolved AE requiring interruption of treatment at the end of the prior parent study (ie, when the parent study is either completed or closed) that in the Investigator's opinion would prevent restarting anifrolumab","Currently receiving or have received prohibited medication(s) as specified in parent protocols prior to signing ICF","Participants who are planning to use live/live-attenuated vaccines","Participants who are planning to use any other therapies, including B-cell therapies, that in the opinion of the Investigator could jeopardize or would compromise the participant's ability to participate in the program as determined by the Investigator"],"whatHappens":"If you join, the listed intervention(s) are Anifrolumab, Anifrolumab, or Anifrolumab. The registry lists allocation as randomized. This study wants to provide continued access to anifrolumab to eligible participants who are continuing to derive clinical benefit from treatment at the end of a parent clinical study, as assessed by the Investigator, while monitoring whether it is safe and how hard side effects are to live with.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,072 people at 142 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.267Z"},{"nctId":"NCT07694674","title":"Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease","officialTitle":"Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Shanghai 10th People's Hospital","sponsorClass":"OTHER","summary":"This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.","conditions":["Inflamatory Bowel Disease","Crohn Disease (CD)"],"keywords":["Crohn's disease","biologics","postoperative","recurrence","efficacy"],"interventions":[{"type":"BIOLOGICAL","name":"Infliximab"},{"type":"BIOLOGICAL","name":"Adalimumab"},{"type":"BIOLOGICAL","name":"Vedolizumab"},{"type":"BIOLOGICAL","name":"Ustekinumab (UST)"}],"enrollment":198,"startDate":"2026-01-16","completionDate":"2026-09-30","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.\n* Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.\n* Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.\n* Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.\n* Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.\n\nExclusion Criteria:\n\n* Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.\n* Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.\n* No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.\n* Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.\n* Other conditions considered by the investigators to be inappropriate for inclusion.","locations":[{"facility":"The Tenth People's Hospital of Shanghai","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Endoscopic recurrence rate"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["adalimumab"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Infliximab for Inflamatory Bowel Disease","inPlainEnglish":"This retrospective cohort study aims to compare the how well it works of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025.","whoItsFor":["Ages 18 Years to 85 Years","Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings","Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection","Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery","Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months","Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence"],"whoShouldSkip":["Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy","Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy","No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment","Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment how well it works difficult to evaluate","Other conditions considered by the investigators to be inappropriate for inclusion"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 198 people at Shanghai. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.269Z"},{"nctId":"NCT07695298","title":"A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome","officialTitle":"A Prospective Longitudinal Analysis of Faricimab (Vabysmo 6mg) For Choroidal Neovascularization in Presumed Ocular Histoplasmosis Syndrome [PLANE Study]","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Cincinnati Eye Institute, Southwest Ohio","sponsorClass":"OTHER","summary":"This study will evaluate the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal conditions, but its use is considered investigational when used specifically for choroidal neovascularization (CNV) related to presumed ocular histoplasmosis (POHS)","conditions":["Presumed Ocular Histoplasmosis"],"keywords":["POHS"],"interventions":[{"type":"DRUG","name":"Faricimab Injection [Vabysmo]"}],"enrollment":25,"startDate":"2026-07","completionDate":"2028-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the Informed Consent Form\n* Ability to comply with study protocol requirements, in the investigator's judgment\n* Willingness to comply with study visits and procedures for the full duration of the 52-week study period\n* For women of childbearing potential: agreement to use highly effective contraception methods or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product, in accordance with local regulatory guidelines\n* For men with partners of childbearing potential: agreement to use effective contraception or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product\n* Presence of choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS), confirmed by funduscopic examination and supported by OCT imaging\n* Best-Corrected Visual Acuity (BCVA) between 20/40 and 20/400, inclusive, using the ETDRS letter score system at screening\n* Central macular subfield thickness (CST) \\>300 microns, as measured by spectral-domain OCT\n* No prior treatment with anti-VEGF agents in the study eye within 6 months prior to screening\n* No presence of other ocular diseases or conditions in the study eye that could confound visual outcomes, interfere with assessment of treatment efficacy, or pose a safety risk (see exclusion criteria)\n\nExclusion Criteria:\n\n* Known hypersensitivity to faricimab or any of its excipients Faricimab\n* Known hypersensitivity to contrast agents (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), anesthetics, or antimicrobial preparations used during the study\n* History of other significant systemic disease, non-diabetic metabolic dysfunction, abnormal physical examination findings, or clinical laboratory abnormalities that, in the opinion of the investigator, could pose a risk to the patient, interfere with study participation, or confound interpretation of study results\n* Active malignancy within 12 months prior to Day 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 and stable PSA for \\>12 months\n* History of stroke (cerebrovascular accident) or myocardial infarction within 12 months prior to Day 1\n* Febrile illness within 1 week prior to Day 1\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab\n\n  o Women of childbearing potential must have a negative urine pregnancy test within 28 days prior to initiation and again at the baseline (Day 1) visit\n* Uncontrolled hypertension, defined as systolic BP \\>180 mmHg and/or diastolic BP \\>100 mmHg at rest; a repeat measurement ≥30 minutes later on the same day is permitted if the initial reading is elevated\n* Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within 6 months prior to Day 1, or anticipated need for dialysis during the study\n* Participation in another investigational trial involving treatment with any drug or device (excluding vitamins/minerals) within 3 months or 5 half-lives (whichever is longer) prior to Day 1, or during the study\n* Clinically significant substance abuse within 12 months prior to screening, in the investigator's judgment\n* Use of systemic immunomodulatory treatments (e.g., IL-6 inhibitors) within 6 months or 5 half-lives (whichever is longer) prior to Day 1\n* Use of systemic corticosteroids within 1 month prior to Day 1\n* Systemic treatment for suspected or active systemic infection\n\n  o Note: Ongoing prophylactic antibiotic therapy is allowed\n* Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1\n* Use of systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, or ethambutol) within 6 months or 5 half-lives (whichever is longer) prior to Day 1\n* Receipt of any treatment resulting in systemic immunosuppression within 6 months or 5 half-lives (whichever is longer) prior to Day 1\n* Requirement for continuous use of medications or therapies listed as prohibited by the protocol\n\nOcular exclusion criteria for study eye:\n\nPatients will be excluded if the study eye meets any of the following criteria:\n\n* Prior intravitreal anti-VEGF therapy within 6 months prior to Day 1 Faricimab\n* Presence of significant ocular pathology other than POHS that may affect visual outcomes or confound study assessments (e.g., retinal vein occlusion, proliferative diabetic retinopathy, central serous chorioretinopathy, or advanced age-related macular degeneration)\n* Presence of a visually significant cataract or other media opacity expected to affect visual acuity or interfere with fundus imaging or OCT evaluation\n* Active intraocular inflammation (e.g., iritis, uveitis, vitritis) in the study eye at screening\n* History of endophthalmitis in the study eye\n* Intraocular pressure \\>25 mmHg in the study eye at screening despite maximum tolerated medical therapy\n* History of vitrectomy or glaucoma filtration surgery in the study eye\n* Any planned ocular surgery in the study eye during the course of the study\n\nOcular exclusion criteria for non-study eye:\n\nPatients will be excluded if the non-study eye meets any of the following criteria:\n\n* Presence of any ocular condition that could interfere with study assessments or the safety of the patient, including but not limited to:\n\n  * Active ocular infection or inflammation\n  * Uncontrolled glaucoma or intraocular pressure ≥ 25 mmHg despite treatment\n  * Advanced diabetic retinopathy requiring immediate treatment\n  * Significant media opacity preventing adequate fundus examination or imaging (e.g., dense cataract, vitreous hemorrhage)\n  * History of vitrectomy or ocular surgery in the past 3 months\n  * Any condition likely to require intraocular injections or ocular surgery during the study period\n* Any known hypersensitivity or allergy to components of faricimab or agents used in ocular procedures (e.g., fluorescein dye, dilating drops)\n* Any ocular comorbidity that, in the investigator's opinion, could confound the evaluation of the study eye or impact patient safety","locations":[{"facility":"Cincinnati Eye Institute","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CVP Physicians Dayton","city":"Dayton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kelye Conrad, Clinical Research Manager","phone":"1+513-569-3688","email":"kconrad@cvphealth.com"}],"primaryOutcomes":["CST Value"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["faricimab"],"locationSlugs":["cincinnati-ohio","dayton-ohio"],"enrichment":{"headline":"Phase 4: testing Faricimab Injection [Vabysmo] for Presumed Ocular Histoplasmosis","inPlainEnglish":"This study will measure the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S. Food and Drug Administration (FDA) for other retinal conditions, but its use is considered investigational when used specifically for choroidal neovascularization (CNV) related to presumed ocular histoplasmosis (POHS)","whoItsFor":["Ages 18 Years to any","Ability to comply with study protocol requirements, in the investigator's judgment","Willingness to comply with study visits and procedures for the full duration of the 52-week study period","For women of childbearing potential: agreement to use highly effective contraception methods or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product, in accordance with local regulatory guidelines","For men with partners of childbearing potential: agreement to use effective contraception or practice complete abstinence during the study and for at least 3 months following the last dose of the investigational product","Presence of choroidal neovascularization (CNV) secondary to presumed ocular histoplasmosis syndrome (POHS), confirmed by funduscopic examination and supported by OCT imaging","Best-Corrected Visual Acuity (BCVA) between 20/40 and 20/400, inclusive, using the ETDRS letter score system at screening","Central macular subfield thickness (CST) \\>300 microns, as measured by spectral-domain OCT"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. This study will measure the safety and effects, good or bad of faricimab (Vabysmo®), a drug that is approved by the U.S.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 25 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.131Z"},{"nctId":"NCT07696962","title":"Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease","officialTitle":"Phase 1 Study of ChoironeX GalKO Porcine Thymokidney Xenotransplantation in End-Stage Renal Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Xeno Holdings (US), LLC dba ChoironeX","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.","conditions":["End Stage Renal Disease"],"keywords":["Kidney, Porcine, Xeno-Transplant"],"interventions":[{"type":"BIOLOGICAL","name":"ChoironeX GalKO Porcine Thymokidney"}],"enrollment":4,"startDate":"2026-11","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months\n* Eligible for kidney transplantation per site criteria\n* \\<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months\n* Blood type and immunologic compatibility with study transplant confirmed by testing\n* EBV seropositive\n* Up to date on recommended vaccinations for immunocompromised individuals\n* Willing to use protocol-required contraception\n* Able to provide informed consent and comply with lifelong follow-up\n\nExclusion Criteria:\n\n* Requirement for multi-organ transplantation\n* Living donor available who is ABO-incompatible\n* Kidney disease with high risk of post-transplant recurrence\n* Polycystic kidney disease without prior native nephrectomy\n* Unable or unwilling to comply with study procedures\n* History of non-adherence to medical treatment\n* Identified as vulnerable by psychological assessment\n* Significant uncontrolled psychiatric illness\n* Inadequate social support or caregiver unavailable/unwilling\n* Current drug or alcohol misuse\n* Serious non-renal illness with life expectancy \\<1 year\n* BMI \\<16 or \\>35 kg/m²\n* Known hypercoagulable disorder\n* Uncontrolled hypertension or hemodynamic instability at enrollment\n* Clinically significant cardiovascular disease, including poorly controlled coronary artery disease, reduced left ventricular function, recent myocardial infarction or cardiac intervention, or clinically significant arrhythmia requiring treatment\n* Serious liver disease or impaired liver function\n* Diabetes mellitus with poor glycemic control (HbA1c \\>10%)\n* Active infection at time of transplantation\n* Positive serology for hepatitis B, hepatitis C, or HIV\n* Current, active, or untreated tuberculosis\n* Malignancy within 5 years prior to enrollment, excluding adequately treated non-melanoma skin cancer\n* Current systemic immunosuppressive therapy (excluding permitted corticosteroids)\n* Participation in another interventional drug trial within 60 days prior to enrollment\n* Pregnant or breastfeeding\n* Known severe hypersensitivity to a required study medication with no acceptable alternative","locations":[{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Study Site 2","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gemma Hodgson","phone":"443-842-0861","email":"ghodgson@xeno-holdings.com"},{"name":"Anna Danilewicz","phone":"662-300-9413","email":"adanilewicz@xeno-holdings.com"}],"primaryOutcomes":["Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) from Day 0 through Month 6.","Overall survival of the recipient without the need for chronic dialysis at Month 6."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 1: testing ChoironeX GalKO Porcine Thymokidney for End Stage Renal Disease","inPlainEnglish":"The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.","whoItsFor":["Ages 18 Years to 70 Years","ESRD receiving hemodialysis or peritoneal dialysis for ≥6 months","Eligible for kidney transplantation per site criteria","\\<50% likelihood of receiving a standard deceased-donor kidney transplant within 12 months","Blood type and immunologic compatibility with study transplant confirmed by testing","Up to date on recommended vaccinations for immunocompromised individuals","Willing to use protocol-required contraception"],"whoShouldSkip":["Requirement for multi-organ transplantation","Living donor available who is ABO-incompatible","Kidney disease with high risk of post-transplant recurrence","Polycystic kidney disease without prior native nephrectomy","History of non-adherence to medical treatment","Identified as vulnerable by psychological assessment","Significant uncontrolled psychiatric illness"],"whatHappens":"If you join, the listed intervention(s) are ChoironeX GalKO Porcine Thymokidney. The registry lists allocation as na. The goal of this clinical trial is to learn if a GalKO Porcine Thymokidney can maintain renal function, without the need for dialysis, after transplantation into adult subjects with End Stage Renal Disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 4 people at 2 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.487Z"},{"nctId":"NCT07697391","title":"AI-Assisted Lifestyle Intervention Versus Tirzepatide for Obesity and Newly Diagnosed Type 2 Diabetes","officialTitle":"A Multicenter Randomized Controlled Trial Evaluating AI-Assisted Intensive Lifestyle Intervention Versus Tirzepatide for Glycemic and Weight Management in Patients With Obesity and Newly Diagnosed Type 2 Diabetes","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The First Affiliated Hospital of Anhui Medical University","sponsorClass":"OTHER","summary":"This multicenter randomized controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible participants will be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.\n\nParticipants will be randomly assigned to one of three groups: an AI-assisted intensive lifestyle intervention group, a tirzepatide treatment group, or a standard lifestyle management control group. The intervention period will last 52 weeks, followed by a 12-week post-intervention follow-up period. The main outcome is the percentage change in body weight at week 52. The study will also assess glycemic control, body composition, continuous glucose monitoring metrics, safety, and other metabolic outcomes.","conditions":["Obesity","Diabetes Mellitus, Type 2"],"keywords":["AI-Assisted Lifestyle Intervention","Tirzepatide","Weight Management","Glycemic Control","Continuous Glucose Monitoring","Randomized Controlled Trial"],"interventions":[{"type":"BEHAVIORAL","name":"AI-Assisted Intensive Lifestyle Intervention"},{"type":"DRUG","name":"Tirzepatide"},{"type":"BEHAVIORAL","name":"Standard Lifestyle Management"}],"enrollment":285,"startDate":"2026-07-16","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged 18 to 65 years.\n2. Newly diagnosed type 2 diabetes mellitus, defined as diagnosis within 3 years and no use of glucose-lowering medications within the past 3 months. Diagnosis should meet the 1999 World Health Organization criteria, including at least one of the following: random plasma glucose ≥11.1 mmol/L, fasting blood glucose ≥7.0 mmol/L, 2-hour postprandial blood glucose ≥11.1 mmol/L, or HbA1c ≥6.5% and ≤10.0%. Participants without typical diabetes symptoms should have repeat testing for confirmation.\n3. Body mass index ≥28 kg/m² and \\<40 kg/m².\n4. Willing to use effective contraception and have no pregnancy plan within 12 months after signing the informed consent form; female participants must have a negative pregnancy test at screening.\n5. Able to communicate with the investigators, willing to comply with the study protocol, and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes.\n2. Body weight change \\>5% within 12 weeks before screening.\n3. Pregnant or breastfeeding women.\n4. Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control.\n5. Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events.\n6. History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \\>1.5 × upper limit of normal at screening.\n7. Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening.\n8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2, or history of thyroid nodules.\n9. Blood dyscrasia or any disease causing hemolysis or unstable red blood cells, or hemoglobinopathy that may affect HbA1c measurement.\n10. History of organ transplantation or acquired or congenital immune system disease.\n11. Schizophrenia or other psychiatric disorder that may interfere with participation in the study.\n12. Unstable or treatment-requiring endocrine disease related to glycemic control, such as hyperthyroidism, acromegaly, or Cushing syndrome, as judged by the investigator.\n13. Hypertension with systolic blood pressure \\>150 mmHg and/or diastolic blood pressure \\>90 mmHg after stable antihypertensive treatment.\n14. Clinically significant abnormal gastric emptying, severe chronic gastrointestinal disease, diabetic gastroparesis, long-term use of medications directly affecting gastrointestinal motility, or history of gastrointestinal surgery.\n15. Special dietary requirements or allergy to foods such as soy products or dairy products.\n16. Use of medications affecting glucose regulation within 3 months before randomization, such as glucocorticoids, growth hormone, thyroid hormone, sex hormones, cyclosporine, or phenytoin.\n17. Allergic constitution, defined as allergy to two or more categories of substances.\n18. Fasting C-peptide \\<0.81 ng/mL.\n19. Calcitonin ≥50 pg/mL.\n20. Abnormal laboratory results, including AST or ALT \\>2.5 × upper limit of normal, bilirubin \\>2.5 × upper limit of normal, triglycerides ≥5.7 mmol/L, estimated creatinine clearance \\<60 mL/min using the Cockcroft-Gault formula, or clinically significant anemia with hemoglobin \\<120 g/L in men or \\<110 g/L in women.\n21. Unstable proliferative retinopathy or maculopathy requiring urgent treatment within 1 year before randomization, or history of diabetic ketoacidosis, hyperosmolar nonketotic coma, or severe metabolic disorder causing neuropsychiatric dysfunction.\n22. History or risk factors of epilepsy, syncope, cardiac arrest, arrhythmia, atrioventricular block, structural heart disease, torsades de pointes, hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia.\n23. Active bacterial, viral, or fungal infection requiring hospitalization or intravenous antibiotic treatment.\n24. Positive HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody.\n25. Positive urine drug screening and/or drug dependence.\n26. Participation in another clinical trial within 3 months before enrollment or current participation in another drug or device clinical trial.\n27. Any other condition that, in the investigator's opinion, makes the participant unsuitable for this study.","locations":[{"facility":"The First Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"First Hospital of Shanxi Medical University","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xueying Zheng","phone":"+8619966188536","email":"lisazhengxy@163.com"}],"primaryOutcomes":["Percent Change in Body Weight From Baseline to Week 52"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["hefei-china","taiyuan-china","wenzhou-china","chongqing-china"],"enrichment":{"headline":"Phase 4: testing Tirzepatide for Obesity","inPlainEnglish":"This multicenter randomly assigned controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management. Eligible you would be adults aged 18 to 65 years with a body mass index of 28 to less than 40 kg/m² and newly diagnosed type 2 diabetes who have not used glucose-lowering medications in the past 3 months.","whoItsFor":["Ages 18 Years to 65 Years","Male or female participants aged 18 to 65 years","Body mass index ≥28 kg/m² and \\<40 kg/m²"],"whoShouldSkip":["Type 1 diabetes mellitus, type 2 diabetes requiring insulin treatment, or other specific types of diabetes","Body weight change \\>5% within 12 weeks before screening","Pregnant or breastfeeding women","Severe trauma, severe infection, or surgery within 1 month before screening that may affect glycemic control","Severe cardiovascular or cerebrovascular events within 6 months before screening, including angina, myocardial infarction, arrhythmia, cerebral infarction, cerebral hemorrhage, or other clinically significant events","History of acute or chronic pancreatitis, history of pancreatic injury, or amylase \\>1.5 × upper limit of normal at screening","Current or previous malignancy, except local basal cell carcinoma of the skin, carcinoma in situ of the cervix, or carcinoma in situ of the prostate; diagnosis of malignancy within 5 years before screening"],"whatHappens":"If you join, the listed intervention(s) are AI-Assisted Intensive Lifestyle Intervention, Tirzepatide, or Standard Lifestyle Management. The registry lists allocation as randomized. This multicenter randomly assigned controlled trial will evaluate whether an AI-assisted intensive lifestyle intervention can improve weight and glycemic management in adults with obesity and newly diagnosed type 2 diabetes, compared with tirzepatide treatment and standard lifestyle management.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 285 people at 5 sites. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.021Z"},{"nctId":"NCT07697456","title":"Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","officialTitle":"A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"AbbVie","sponsorClass":"INDUSTRY","summary":"Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.","conditions":["Crohn's Disease","Ulcerative Colitis"],"keywords":["Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066"],"interventions":[{"type":"DRUG","name":"Risankizumab"},{"type":"DRUG","name":"Trosunilimab"},{"type":"DRUG","name":"ABBV-701"}],"enrollment":2000,"startDate":"2026-07-31","completionDate":"2031-10","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\< 10 cm of rectum","locations":[{"facility":"Digestive Health Specialists /ID# 280827","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Elite Clinical Studies /ID# 280477","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gi Alliance - Arizona Digestive Health - Sun City /ID# 284084","city":"Sun City","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinnova Research /ID# 280509","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Res. Ctr /ID# 280476","city":"Coronado","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Care Institute /ID# 281071","city":"Lancaster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"United Medical Doctors - Los Alamitos /ID# 281125","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Liver Foundation - Rialto /ID# 280775","city":"Rialto","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 280507","city":"Colorado Springs","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Synergy Healthcare - Bradenton /ID# 284157","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Osceola /ID# 280593","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Center For Gastroenterology - Largo /ID# 281059","city":"Largo","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Associates of South Florida /ID# 280929","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Research Institute, Inc /ID# 281062","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive And Liver Center Of Florida - Orlando /ID# 280924","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gcp Clinical Research /ID# 280469","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates of Central Georgia /ID# 280464","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Consultants - Roswell /ID# 281235","city":"Roswell","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Treasure Valley Medical Research /ID# 281778","city":"Boise","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Digestive Health & Nutrition /ID# 285250","city":"Des Plaines","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gi Alliance - Glenview /ID# 283932","city":"Glenview","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Illinois Gastroenterology Group /ID# 283933","city":"Gurnee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southwest Gastroenterology - Oak Lawn /ID# 280841","city":"Oak Lawn","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Health Partners /ID# 284145","city":"New Albany","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Health Partners /ID# 284144","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Group and Endocenter: Mandeville, la /ID# 284186","city":"Mandeville","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metropolitan Gastroenterology Associates - Metairie /ID# 283922","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Willis-Knighton Medical Center /ID# 280572","city":"Shreveport","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lucida Clinical Trials /ID# 282000","city":"New Bedford","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Michigan Clinical Research Center /ID# 280480","city":"Wyoming","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gi Associates - Gia And Endoscopy Center - Flowood /ID# 283967","city":"Flowood","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates Of North Mississippi /ID# 285243","city":"Oxford","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Specialists In Gastroenterology /ID# 283939","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vector Clinical Trials /ID# 280843","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York Gastroenterology Associates - Upper East Side /ID# 281767","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Digestive Health Partners /ID# 280490","city":"Asheville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dayton Gastroenterology - Beavercreek /ID# 284065","city":"Beavercreek","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro Intestinal Research Institute of Northern Ohio /ID# 283860","city":"Westlake","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Gastroenterology - Providence - Staniford Street /ID# 280919","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastroenterology Associates - Patewood /ID# 283870","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastrointestinal Associates - Knoxville - Dowell Springs Boulevard /ID# 283861","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gastro One - Memphis /ID# 283948","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novel Research - Bellaire /ID# 280925","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gi Alliance - Texas Digestive Disease Consultants - Fort Worth /ID# 283977","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance -Garland /ID# 284253","city":"Garland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Amel Med /ID# 283864","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integrity Advanced Therapeutics /ID# 283871","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Lubbock /ID# 283920","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Caprock Gastro Research - Lubbock /ID# 283921","city":"Lubbock","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Mansfield /ID# 283924","city":"Mansfield","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Star Research Institute /ID# 280822","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Digestive Disease /ID# 280870","city":"Shenandoah","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Digestive Disease Consultants - Southlake /ID# 283931","city":"Southlake","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tyler Research Institute /ID# 284247","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Digestive Disease Consultants /ID# 284245","city":"Webster","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emeritas Research Group /ID# 284388","city":"Lansdowne Town Center","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GI Alliance - Richmond /ID# 284244","city":"Richmond","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Gastroenterology - Bellevue /ID# 283966","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington Gastroenterology - Tacoma /ID# 284143","city":"Tacoma","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Vancouver Clinic /ID# 280497","city":"Vancouver","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wisconsin Center for Advanced Research /ID# 284250","city":"Milwaukee","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diex Recherche Quebec Inc. /ID# 282307","city":"Québec","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Assuta Ashdod Medical Center /ID# 280535","city":"Ashdod","state":"Southern District","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kure Kyosai Hospital /ID# 282006","city":"Kure","state":"Hiroshima","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 280640","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital /ID# 280630","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ABBVIE CALL CENTER","phone":"844-663-3742","email":"abbvieclinicaltrials@abbvie.com"}],"primaryOutcomes":["Crohn's Disease Specific: Percentage of Participants Achieving Endoscopic Remission","Ulcerative Colitis Specific: Percentage of Participants who Achieve Endoscopic Remission","Number of Participants with Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":["risankizumab"],"locationSlugs":["dothan-alabama","phoenix-arizona","sun-city-arizona","anaheim-california","coronado-california","lancaster-california","los-alamitos-california","rialto-california","colorado-springs-colorado","bradenton-florida","kissimmee-florida","largo-florida","miami-florida","new-port-richey-florida","orlando-florida","tampa-florida","macon-georgia","roswell-georgia","boise-idaho","des-plaines-illinois","glenview-illinois","gurnee-illinois","oak-lawn-illinois","new-albany-indiana","louisville-kentucky","mandeville-louisiana","metairie-louisiana","shreveport-louisiana","new-bedford-massachusetts","wyoming-michigan","flowood-mississippi","oxford-mississippi","st-louis-missouri","las-vegas-nevada","new-york-new-york","asheville-north-carolina","beavercreek-ohio","westlake-ohio","providence-rhode-island","greenville-south-carolina","knoxville-tennessee","memphis-tennessee","bellaire-texas","fort-worth-texas","garland-texas","georgetown-texas","houston-texas","lubbock-texas","mansfield-texas","san-antonio-texas","shenandoah-texas","southlake-texas","tyler-texas","webster-texas","lansdowne-town-center-virginia","richmond-virginia","bellevue-washington","tacoma-washington","vancouver-washington","milwaukee-wisconsin","qu-bec-canada","ashdod-israel","kure-japan","kaohsiung-city-taiwan","taichung-taiwan"],"enrichment":{"headline":"Phase 2: testing Risankizumab for Crohn's Disease","inPlainEnglish":"Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss.","whoItsFor":["Ages 18 Years to 75 Years","Crohn's Disease Activity Index (CDAI) score of ≥ 220","Confirmed diagnosis of CD at least 90 days prior to Baseline","Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease","Demonstrated failure of 1 or more therapy for CD","Confirmed diagnosis of UC at least 90 days prior to Baseline","Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3","Demonstrated failure of 1 or more therapy for UC"],"whoShouldSkip":["Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)","Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment","Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame","Participants with surgical bowel resection within the past 3 months prior to Baseline","Participants with \\>3 prior bowel resections","Participants with previous small bowel resection(s) of combined length \\>100 cm","Participants with prior colectomy (total or subtotal)"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab, Trosunilimab, or ABBV-701. The registry lists allocation as randomized. Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 2,000 people at 66 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.569Z"},{"nctId":"NCT07698925","title":"Diaphragmatic Breathing Exercises on Sleep Disorders un Polycystic Ovarian Syndrome","officialTitle":"Effect of Diaphragmatic Breathing on Sleep Disorders in Polycystic Ovarian Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Adly A Adam","sponsorClass":"OTHER","summary":"Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood. Women with PCOS appear to have an increased frequency of sleep problems. Diaphragmatic Breathing (DB) exercises has positive effects on improving sleep quality. The purpose of this study will evaluate the effect of diaphragmatic breathing exercises on improving sleep quality in polycystic ovarian syndrome women.","conditions":["Polycystic Ovarian Syndrome (PCOS)","Pittsburg Sleep Quality Index","Fatigue Severity Scale","Insomnia Severity Index","Diaphragmatic Breathing Exercise","Sleep Disorders"],"keywords":["Polycystic ovary syndrome","Diaphragmatic breathing exercises","Sleep disorders","Pittsburg sleep quality index","Insomnia severity index","Fatigue severity scale"],"interventions":[{"type":"OTHER","name":"Diaphragmatic breathing exercises"},{"type":"OTHER","name":"Lifestyle modification advices"}],"enrollment":54,"startDate":"2026-07-11","completionDate":"2026-09-01","sex":"FEMALE","minAge":"25 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria.\n\n  * They have a Pittsburgh sleep quality index (PSQI) score greater than 5.\n  * Not participating in any physical exercise for the previous 3 months.\n  * They have an insomnia severity index score greater than 15.\n  * They have a fatigue severity scale score greater than 36.\n  * Ability to use internet and phone services\n\nExclusion Criteria:\n\n* • Women with autoimmune diseases and cancer.\n\n  * Women with neurological, mental, cardiopulmonary and musculoskeletal disorders.\n  * Pregnant or lactating women.\n  * Women who showed regular adherence to sleeping pills, antidepressants and hormonal replacement agents.\n  * Inability to perform diaphragmatic breathing due to physical limitations.\n  * Women who participate or receive any interventions that could affect their sleep","locations":[{"facility":"Cairo University; Faculty of Physical Therapy","city":"Cairo","state":"Cairo Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naira H Mohamed, B.Sc","phone":"01287797493","email":"nairahesham083@gmail.com"},{"name":"Mai M Shehata, PHD","phone":"01287797493","email":"adampt80a@gmail.com"}],"primaryOutcomes":["Pittsburgh Sleep Quality Index (PSQI)"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["cairo-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Diaphragmatic breathing exercises for Polycystic Ovarian Syndrome (PCOS)","inPlainEnglish":"Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood. Women with PCOS appear to have an increased frequency of sleep problems.","whoItsFor":["Ages 25 Years to 35 Years","Women only","Women aged from 25-35 years old, Diagnosed with PCOS by gynecologist, diagnosis of PCOS will be based on the 2003 Rotterdam criteria","They have a Pittsburgh sleep quality index (PSQI) score greater than 5","Not participating in any physical exercise for the previous 3 months","They have an insomnia severity index score greater than 15","They have a fatigue severity scale score greater than 36","Ability to use internet and phone services"],"whoShouldSkip":["Women with autoimmune diseases and cancer","Women with neurological, mental, cardiopulmonary and musculoskeletal disorders","Pregnant or lactating women","Women who showed regular adherence to sleeping pills, antidepressants and hormonal replacement agents","Inability to perform diaphragmatic breathing due to physical limitations","Women who participate or receive any interventions that could affect their sleep"],"whatHappens":"If you join, the listed intervention(s) are Diaphragmatic breathing exercises, or Lifestyle modification advices. The registry lists allocation as randomized. Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in females in reproductive age and not completely understood.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 54 people at Cairo. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.796Z"},{"nctId":"NCT07699328","title":"A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer","officialTitle":"A Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of VRN110755 in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Voronoi, Inc","sponsorClass":"INDUSTRY","summary":"This first-in-human, Phase 1/2, multicenter, open-label, non-randomized study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).\n\nThe study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation. The study is designed to determine the maximum tolerated dose and recommended Phase 2 dose of VRN110755 and to evaluate preliminary and confirmatory antitumor activity in patients with EGFR-mutant NSCLC, including patients with acquired resistance following EGFR tyrosine kinase inhibitor therapy.","conditions":["EGFR-Mutant Non-Small Cell Lung Cancer"],"keywords":["NSCLC","EGFR","Epidermal Growth Factor Receptor","Non-Small Cell Lung Cancer","EGFR Mutation","C797S","EGFR Tyrosine Kinase Inhibitor Resistance"],"interventions":[{"type":"DRUG","name":"VRN110755"}],"enrollment":315,"startDate":"2024-03-26","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older (19 years or older in the Republic of Korea).\n* Able to understand, sign, and provide written informed consent.\n* Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation.\n* At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n* Documented EGFR mutation determined by tumor tissue or liquid biopsy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Able to swallow oral capsules and comply with study procedures.\n* Women of childbearing potential must have a negative pregnancy test, must not be breastfeeding, and must agree to use effective contraception during the study and for 7 months after the last safety follow-up visit. Men must agree to use effective contraception during the study and for 6 months after the last safety follow-up visit.\n* No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator.\n* Participants must meet the disease-specific eligibility criteria for one of the following study groups:\n\n  * Phase 1a\n\n    * NSCLC with EGFR activating, resistant, uncommon, or complex mutations, including but not limited to exon 19 deletion (Del19), L858R, C797S, or other uncommon EGFR mutations.\n    * Radiographic disease progression following at least 2 cycles of prior EGFR tyrosine kinase inhibitor (TKI) therapy or discontinuation of prior EGFR TKI therapy because of toxicity, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort A\n\n    * NSCLC with EGFR exon 19 deletion or L858R mutation plus a C797X resistance mutation following disease progression after first-line treatment with a third-generation EGFR TKI (including osimertinib, lazertinib, or aumolertinib).\n  * Phase 1b - Cohort B\n\n    * Treatment-naïve NSCLC with common EGFR mutations.\n  * Phase 1b - Cohort C\n\n    * NSCLC with atypical or uncommon EGFR mutations (including G719X, L861Q, S768I, E709X, R776H, L747S, or combinations of these mutations) previously treated with at least one systemic therapy, including an EGFR TKI, with no remaining standard therapy expected to provide clinical benefit.\n  * Phase 1b - Cohort D\n\n    * Treatment-naïve NSCLC with atypical EGFR mutations.\n\nExclusion Criteria:\n\n* Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment.\n* Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), except for Grade 2 peripheral neuropathy or alopecia.\n* Pregnant or breastfeeding, or planning to become pregnant during the study.\n* NSCLC with an EGFR or HER2 exon 20 insertion mutation.\n* Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured.\n* Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria.\n* Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.\n* Active hepatitis B or hepatitis C infection, or known human immunodeficiency virus (HIV) infection.\n* Receipt of a live vaccine within 4 weeks before the first dose of study treatment.\n* Use of strong or moderate cytochrome P450 (CYP) 3A inhibitors or inducers, certain herbal supplements, or other prohibited medications within the protocol-defined washout period.\n* Major surgery within 4 weeks before the first dose of study treatment or incomplete recovery from major surgery.\n* Receipt of prior anticancer therapy within the protocol-defined washout period, including systemic therapy, immunotherapy, or radiotherapy.\n* Symptomatic or uncontrolled central nervous system (CNS) metastases or spinal cord compression requiring increasing doses of corticosteroids. Participants with treated and stable CNS metastases or asymptomatic CNS disease may be eligible.\n* Requirement for systemic corticosteroid therapy exceeding the protocol-defined limit.\n* Clinically significant cardiovascular disease, including prolonged QT interval, clinically significant arrhythmias, recent myocardial infarction, unstable angina, congestive heart failure, uncontrolled hypertension, reduced left ventricular ejection fraction, or use of medications known to prolong the QT interval.\n* History of interstitial lung disease, noninfectious pneumonitis requiring steroid treatment, or current interstitial lung disease or pneumonitis.\n* Inability to swallow oral capsules or gastrointestinal disorders that may interfere with absorption of study treatment.\n* Known allergy or hypersensitivity to VRN110755 or any of its components.\n* Alcohol or drug abuse within the previous 2 years or any medical, psychological, or social condition that, in the opinion of the investigator, would interfere with study participation or interpretation of study results.\n* Use of proton pump inhibitors, histamine-2 receptor antagonists, or locally acting antacids within the protocol-defined washout period or inability to comply with protocol requirements for acid-reducing medications.\n* For Phase 1b and Phase 2 only: Presence of another targetable oncogenic driver alteration with an approved targeted therapy, including MET or HER2 amplification; ALK, ROS1, NTRK, or RET fusion; or BRAF V600E or KRAS G12X mutation.","locations":[{"facility":"Southern Oncology Clinical Research Unit","city":"Bedford Park","state":"South Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monash Medical Centre Clayton","city":"Clayton","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Princess Margaret Cancer Centre","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"AP-HM Hôpital Nord","city":"Marseille","state":"Bouches-du-Rhône","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Georges François Leclerc","city":"Dijon","state":"Côte-d'Or","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prince of Wales Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Mary Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Umum Sarawak","city":"Kuching","state":"Sarawak","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Kuala Lumpur","city":"Kuala Lumpur","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Malaya Medical Centre","city":"Kuala Lumpur","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institut Kanser Negara","city":"Putrajaya","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Centre Singapore","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tan Tock Seng Hospital","city":"Singapore","state":"","country":"Singapore","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, St. Vincent's Hospital","city":"Suwon","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chungbuk National University Hospital","city":"Cheongju-si","state":"North Chungcheong","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICO Badalona - Hospital Universitari Germans Trias i Pujol","city":"Badalona","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICO l'Hospitalet - Hospital Duran i Reynals","city":"L'Hospitalet de Llobregat","state":"Barcelona","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Málaga - Hospital Civil","city":"Málaga","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kaohsiung Medical University Chung-Ho Memorial Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Medical University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Phramongkutklao Hospital","city":"Thung Phaya Thai","state":"Bangkok Metropolis","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Songklanagarind Hospital Prince of Songkla University","city":"Hat Yai","state":"Changwat Songkhla","country":"Thailand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Information","phone":"+82 32 219 7849","email":"information_clinicaltrial_11@voronoi.io"}],"primaryOutcomes":["Estimate of Maximum Tolerated Dose (MTD) of VRN110755","Number of participants with dose-limiting toxicities (DLTs) following treatment with VRN110755","Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events leading to discontinuation","Number of participants with changes in vital signs from baseline following treatment with VRN110755","Number of participants with changes in laboratory test results from baseline following treatment with VRN110755","Number of participants with changes in physical examination findings from baseline following treatment with VRN110755","Number of participants with changes in ophthalmologic examination findings from baseline following treatment with VRN110755","Number of participants with changes in electrocardiogram (ECG) parameters from baseline following treatment with VRN110755","Number of participants with changes in Eastern Cooperative Oncology Group (ECOG) Performance Status from baseline following treatment with VRN110755"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["bedford-park-australia","clayton-australia","toronto-canada","marseille-france","dijon-france","hong-kong-hong-kong","kuching-malaysia","kuala-lumpur-malaysia","putrajaya-malaysia","singapore-singapore","seongnam-si-south-korea","suwon-south-korea","cheongju-si-south-korea","seoul-south-korea","badalona-spain","lhospitalet-de-llobregat-spain","madrid-spain","m-laga-spain","kaohsiung-city-taiwan","taichung-taiwan","taipei-taiwan","thung-phaya-thai-thailand","hat-yai-thailand"],"enrichment":{"headline":"Phase 1 / Phase 2: testing VRN110755 for EGFR-Mutant Non-Small Cell Lung Cancer","inPlainEnglish":"This first-in-human, Phase 1/2, multicenter, open-label, non-randomly assigned study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC). The study includes a Phase 1a dose-escalation portion, a Phase 1b dose-expansion portion, and a Phase 2 evaluation.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older (19 years or older in the Republic of Korea)","Histologically or cytologically confirmed advanced, metastatic, or recurrent predominantly nonsquamous non-small cell lung cancer (NSCLC) with a documented epidermal growth factor receptor (EGFR) mutation","At least one measurable extracranial lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1","Documented EGFR mutation determined by tumor tissue or liquid biopsy","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Able to swallow oral capsules and comply with study procedures","No appropriate standard treatment options are available or standard treatment is not considered feasible, in the opinion of the investigator"],"whoShouldSkip":["Received an investigational anticancer therapy within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment","Unresolved side effects from previous anticancer therapy greater than Grade 1 according to the National Cancer Institute Common Terminology Criteria for side effects (CTCAE), except for Grade 2 peripheral neuropathy or alopecia","Pregnant or breastfeeding, or planning to become pregnant during the study","NSCLC with an EGFR or HER2 exon 20 insertion mutation","Another active malignancy within the past 3 years, with the exception of adequately treated cancers considered cured","Inadequate bone marrow, kidney, or liver function based on protocol-defined laboratory criteria","Active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment"],"whatHappens":"If you join, the listed intervention(s) are VRN110755. The registry lists allocation as randomized. This first-in-human, Phase 1/2, multicenter, open-label, non-randomly assigned study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of VRN110755, a highly selective oral epidermal growth factor receptor (EGFR) inhibitor, in patients with EGFR-mutant non-small cell lung cancer (NSCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 315 people at 29 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.671Z"},{"nctId":"NCT07700056","title":"A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","officialTitle":"A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).","conditions":["Chronic Pruritus of Unknown Origin"],"keywords":["BTK inhibitor","chronic pruritus","chronic pruritus of unknown origin","CPUO","remibrutinib"],"interventions":[{"type":"DRUG","name":"Remibrutinib"},{"type":"DRUG","name":"Placebo"}],"enrollment":180,"startDate":"2026-08-24","completionDate":"2029-12-19","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age, at the time of signing the informed consent.\n* Participants with chronic pruritus for at least 4 months prior to screening.\n* Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures).\n* Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution).\n* Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy.\n* Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch.\n* Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit.\n* The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10).\n* Participants must have PGIS of pruritus scored as 3 \"severe\" at screening and baseline visits.\n\nKey Exclusion Criteria:\n\n* Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO.\n* Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus.\n* Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected HIV infection.\n* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.\n* Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited.\n* History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.","locations":[{"facility":"Aller Vie Health-Cullman","city":"Cullman","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Driven Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aeroallergy Research Laboratories","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Rea Group","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern IN Clinical Trials","city":"New Albany","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Equity Medical","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optima Research-Boardman","city":"Boardman","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy and Clinical Immunology Associates","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Allergy and Asthma Research LLS","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Inst for Clinical Research","city":"Pflugerville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Caba","state":"Buenos Aires","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Rosario","state":"Santa Fe Province","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Québec","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kitakyushu","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kumamoto","state":"Kumamoto","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Habikino","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tachikawa","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ansan","state":"Gyeonggi-do","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["cullman-alabama","miami-florida","savannah-georgia","indianapolis-indiana","new-albany-indiana","the-bronx-new-york","boardman-ohio","pittsburgh-pennsylvania","north-charleston-south-carolina","pflugerville-texas","caba-argentina","rosario-argentina","hamilton-canada","qu-bec-canada","kitakyushu-japan","yokohama-japan","kumamoto-japan","habikino-japan","sakai-japan","tachikawa-japan","ansan-south-korea","seoul-south-korea"],"enrichment":{"headline":"Phase 3: testing Remibrutinib for Chronic Pruritus of Unknown Origin","inPlainEnglish":"The purpose of this phase 3 study is to establish the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).","whoItsFor":["Ages 18 Years to any","Participants with chronic pruritus for at least 4 months prior to screening","Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures)","Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution)","Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy","Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch","Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit","The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10)"],"whoShouldSkip":["Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO","Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus","History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases"],"whatHappens":"If you join, the listed intervention(s) are Remibrutinib, or Placebo. The registry lists allocation as randomized. The purpose of this phase 3 study is to establish the how well it works, whether it is safe and how hard side effects are to live with of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 180 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:30.836Z"},{"nctId":"NCT07701343","title":"tACS for Working Memory in Schizophrenia","officialTitle":"Efficacy and Mechanisms of Transcranial Alternating Current Stimulation in Improving Working Memory in Patients With Schizophrenia","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Central South University","sponsorClass":"OTHER","summary":"This study is a randomized, single-blind, sham-controlled crossover trial enrolling 30 schizophrenia patients, each receiving one active and one sham tACS session (7-day washout), targeting P3/P4 at individual alpha frequency (2mA, 30min) during a working memory task, with accuracy and reaction time as primary outcomes, alongside EEG and neurophysiological measures, to test the efficacy and mechanisms of individualized alpha-tACS on working memory.","conditions":["Schizophrenia","Working Memory"],"keywords":["Schizophrenia","Working Memory","Transcranial Alternating Current Stimulation"],"interventions":[{"type":"DEVICE","name":"transcranial alternating current stimulation"},{"type":"DEVICE","name":"sham stimulation"}],"enrollment":30,"startDate":"2026-10-26","completionDate":"2026-10-31","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18-50 years, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).\n* Spatial span T-score \\<40 on the MATRICS Consensus Cognitive Battery (MCCB).\n* Taking 1-2 antipsychotic medications, with stable dosage for at least 1 week prior to enrollment. No use of mood stabilizers, antidepressants, or excessive benzodiazepines (lorazepam equivalent \\>2 mg/day). The type and dosage of antipsychotic medications remain unchanged during the treatment period.\n* Impaired functioning in daily activities.\n* Willing to participate in this study and provide written informed consent.\n\nExclusion Criteria:\n\n* Previously diagnosed with or comorbid any other DSM-5 mental disorder besides schizophrenia.\n* Presence of significant mood symptoms or substance use disorder (other than caffeine and/or tobacco).\n* Presence of any contraindication to transcranial alternating current stimulation (tACS).\n* Received other forms of electrical or magnetic stimulation therapy within 1 month prior to enrollment.\n* History or current presence of any major physical illness, neurological disorder, or traumatic brain injury that may affect brain structure or function.\n* Pregnant or breastfeeding women, or women planning to become pregnant during the study period.","locations":[{"facility":"The Second Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Renrong Wu","phone":"15874179855","email":"wurenrong@csu.edu.cn"}],"primaryOutcomes":["Working Memory Accuracy","Working Memory Reaction Time"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["changsha-china"],"enrichment":{"headline":"Not a traditional drug phase: transcranial alternating current stimulation for Schizophrenia","inPlainEnglish":"This study is a randomly assigned, you will not be told which treatment you get, sham-controlled crossover trial enrolling 30 schizophrenia patients, each receiving one active and one sham tACS session (7-day washout), targeting P3/P4 at individual alpha frequency (2mA, 30min) during a working memory task, with accuracy and reaction time as primary outcomes, alongside EEG and neurophysiological measures, to test the how well it works and mechanisms of individualized alpha-tACS on working memory.","whoItsFor":["Ages 18 Years to 50 Years","Aged 18-50 years, meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)","Spatial span T-score \\<40 on the MATRICS Consensus Cognitive Battery (MCCB)","Impaired functioning in daily activities"],"whoShouldSkip":["Previously diagnosed with or comorbid any other DSM-5 mental disorder besides schizophrenia","Presence of significant mood symptoms or substance use disorder (other than caffeine and/or tobacco)","Presence of any contraindication to transcranial alternating current stimulation (tACS)","Received other forms of electrical or magnetic stimulation therapy within 1 month prior to enrollment","History or current presence of any major physical illness, neurological disorder, or traumatic brain injury that may affect brain structure or function","Pregnant or breastfeeding women, or women planning to become pregnant during the study period"],"whatHappens":"If you join, the listed intervention(s) are transcranial alternating current stimulation, or sham stimulation. The registry lists allocation as randomized. This study is a randomly assigned, you will not be told which treatment you get, sham-controlled crossover trial enrolling 30 schizophrenia patients, each receiving one active and one sham tACS session (7-day washout), targeting P3/P4 at individual alpha frequency (2mA, 30min) during a working memory task, with accuracy and reaction time as primary outcomes, alongside EEG and neurophysiological measures, to test the how well it works and mechanisms of individualized alpha-tACS on working memory.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Changsha. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.045Z"},{"nctId":"NCT07702175","title":"Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy","officialTitle":"The Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography Procedure in Individuals With Type 2 Diabetes Who Have Diabetic Neuropathy: A Randomized Controlled Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Nurgül Gün","sponsorClass":"OTHER","summary":"This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes.\n\nEMG is a diagnostic method that can cause pain and anxiety in patients. Due to the limited number of non-pharmacological studies in the literature focusing on pain management in diabetic individuals during this process, the investigation of the effectiveness of the 4-7-8 breathing technique, which strengthens parasympathetic activity, using a randomized controlled design constitutes the unique value of this study.\n\nThe research will be conducted in a randomized controlled experimental design. The sample will consist of individuals diagnosed with Type 2 diabetes who are referred to the EMG outpatient clinic of Osmaniye Training and Research Hospital. The experimental group will receive training on the 4-7-8 breathing technique and will be instructed to apply it during the procedure, while the control group will receive the routine clinical protocol. Data will be collected using the Patient Identification Form, Numerical Rating Scale (NRS), State Anxiety Scale (SAS), and Neuropathic Pain Questionnaire (DN4). The study expects the 4-7-8 breathing technique to significantly reduce pain and anxiety levels. It aims to improve the comfort of diabetic patients during procedures and the quality of diagnostic data, and to introduce this method into the literature as a low-cost and independent pain management strategy in nursing care. Furthermore, the study aligns with the \"Health and Quality of Life\" (SDG3) goal, which is part of the Sustainable Development Goals set by the United Nations. SDG3 offers a comprehensive global framework aimed at ensuring healthy living for all individuals and promoting well-being at all ages; it includes increasing access to health services, improving the quality of care, and strengthening patient-centered approaches.","conditions":["Diabetic Neuropathies","Diabetes Mellitus (Type 2)","Pain","Anxiety"],"keywords":["Type 2 Diabetes","Electromyography","4-7-8 Breathing Technique","Pain","Anxiety"],"interventions":[{"type":"BEHAVIORAL","name":"4-7-8 Breathing Technique"}],"enrollment":100,"startDate":"2026-07-13","completionDate":"2027-02-15","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals aged 18-70 years who:\n\n  * Have been diagnosed with Type 2 DM for at least one year,\n  * Have diabetic peripheral neuropathy and are taking medications with a DN4 score \\>3,\n  * Are cooperative and can communicate in Turkish. • Do not have orthopedic or surgical contraindications that would prevent them from undergoing testing.\n\nExclusion Criteria:\n\n* • Individuals with severe autonomic neuropathy findings (resting tachycardia, etc.),\n\n  * Individuals with respiratory system diseases that prevent deep breathing, such as COPD and asthma,\n  * Individuals with active infection or compromised skin integrity (dryness, cracks, open wounds, lesions, etc.) in the area where EMG will be performed,\n  * Individuals with a mass (tumor, cystic formation, etc.) in the anatomical area where EMG will be performed,\n  * Individuals with varicose veins (signs of venous insufficiency) in the anatomical area where EMG will be performed,\n  * Individuals with edema in the area where EMG will be performed that may affect the quality of electrophysiological recordings,\n  * Individuals with a dialysis catheter, central venous catheter, or implanted venous port,\n  * Individuals who have used analgesics (painkillers) within 24 hours prior to the procedure,\n  * Individuals who cannot follow breath commands due to hearing or visual impairment. • Individuals with any muscle disease,\n  * Individuals receiving chemotherapy/radiotherapy treatment at any time,\n  * Individuals who have undergone knee, hip, or lumbar surgery,\n  * Pregnant women,\n  * Individuals with any inflammatory rheumatic disease,\n  * Patients with pacemakers or ICDs,\n  * Individuals with chronic kidney failure","locations":[{"facility":"Osmaniye Training and Research Hospital","city":"Osmaniye","state":"Osmaniye","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nurgül GÜN, MSc, RN","phone":"+90 553 869 46 78","email":"nurgul.gun@hku.edu.tr"}],"primaryOutcomes":["Pain Score"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":[],"locationSlugs":["osmaniye-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: 4-7-8 Breathing Technique for Diabetic Neuropathies","inPlainEnglish":"This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes. EMG is a diagnostic method that can cause pain and anxiety in patients.","whoItsFor":["Ages 18 Years to 70 Years","Individuals aged 18-70 years who:","Have been diagnosed with Type 2 DM for at least one year,","Have diabetic peripheral neuropathy and are taking medications with a DN4 score \\>3,","Are cooperative and can communicate in Turkish. • Do not have orthopedic or surgical contraindications that would prevent them from undergoing testing"],"whoShouldSkip":["Individuals with severe autonomic neuropathy findings (resting tachycardia, etc.),","Individuals with respiratory system diseases that prevent deep breathing, such as COPD and asthma,","Individuals with active infection or compromised skin integrity (dryness, cracks, open wounds, lesions, etc.) in the area where EMG will be performed,","Individuals with a mass (tumor, cystic formation, etc.) in the anatomical area where EMG will be performed,","Individuals with varicose veins (signs of venous insufficiency) in the anatomical area where EMG will be performed,","Individuals with edema in the area where EMG will be performed that may affect the quality of electrophysiological recordings,","Individuals with a dialysis catheter, central venous catheter, or implanted venous port,"],"whatHappens":"If you join, the listed intervention(s) are 4-7-8 Breathing Technique. The registry lists allocation as randomized. This study aims to determine the effect of the 4-7-8 breathing technique, applied during Electromyography (EMG) for the diagnosis of diabetic peripheral neuropathy, on the pain and anxiety levels experienced by patients with Type 2 diabetes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Osmaniye. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.525Z"},{"nctId":"NCT07703436","title":"Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","officialTitle":"A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Nuvation Bio Inc.","sponsorClass":"INDUSTRY","summary":"This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \\[BICR\\] per modified Response Assessment in Neuro-Oncology \\[RANO\\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.","conditions":["Grade 2 IDH1-mutant Glioma","Grade 3 IDH1-mutant Glioma","Glioma","IDH1-mutant Glioma","Oligodendroglioma","Oligodendroglioma IDH-1 Mutant and 1/p19q-codeleted","Astrocytoma IDH Mutant Grade 3","Astrocytoma IDH Mutant Grade 2"],"keywords":[],"interventions":[{"type":"DRUG","name":"Safusidenib"}],"enrollment":40,"startDate":"2027-03","completionDate":"2030-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria\n* IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).\n* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).\n* Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.\n* Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0.\n* Adequate hematologic and organ function\n* Expected survival of ≥12 months\n\nKey Exclusion Criteria:\n\n* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.\n* Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression\n* Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.\n* Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n* Significant functional or neurocognitive deficits, including uncontrolled seizures\n* Evidence of leptomeningeal disease.\n* Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\<1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.","locations":[{"facility":"University of California, Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Miami Health","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indiana University","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"LSU LCMC Health Cancer Center","city":"New Orleans","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rutgers Cancer Institute","city":"New Brunswick","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials at Nuvation Bio","phone":"332-208-6102","email":"ClinicalTrials@nuvationbio.com"}],"primaryOutcomes":["Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","new-haven-connecticut","miami-florida","indianapolis-indiana","new-orleans-louisiana","boston-massachusetts","new-brunswick-new-jersey","new-york-new-york","cleveland-ohio","columbus-ohio"],"enrichment":{"headline":"Phase 2: testing Safusidenib for Grade 2 IDH1-mutant Glioma","inPlainEnglish":"This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \\[BICR\\] per modified Response Assessment in Neuro-Oncology \\[RANO\\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.","whoItsFor":["Ages 18 Years to any","Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria","IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS)","Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection)","Measurable disease per modified RANO 2.0 confirmed by BICR during Screening","Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0","Adequate hematologic and organ function","Expected survival of ≥12 months"],"whoShouldSkip":["Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma","Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression","Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma","Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension","Significant functional or neurocognitive deficits, including uncontrolled seizures","Evidence of leptomeningeal disease","Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\<1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted"],"whatHappens":"If you join, the listed intervention(s) are Safusidenib. The registry lists allocation as na. This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review \\[BICR\\] per modified Response Assessment in Neuro-Oncology \\[RANO\\] 2.0), and are not in need of immediate chemotherapy or radiotherapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.419Z"},{"nctId":"NCT07703891","title":"Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa","officialTitle":"Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"Consistent use of antiretroviral therapy (ART) is essential for achieving suppression among people with HIV (PWH). Yet despite improvements in access to ART and improving viral suppression rates, an estimated one-third of PWH globally do not take ART as prescribed, thus allowing the virus to remain detectable and transmissible. This study tests whether a low-cost visual education tool, B-OK bottles, improves understanding of HIV, antiretroviral therapy (ART), and the concept of Undetectable = Untransmittable (U=U) among adults in Gauteng, South Africa using a randomized trial. Participants will be randomly assigned to one of three groups: (1) standard-of-care verbal information based on Department of Health guidelines, (2) information delivered in person using B-OK bottles, or (3) information delivered via a video demonstrating the B-OK bottles. The study will compare the two intervention formats to standard care, and to each other, to assess whether the tool improves knowledge, attitudes, and intentions related to HIV treatment and prevention, and whether the intervention results depend on delivery mode (in-person vs. video). Outcomes will be measured at baseline, immediately after the intervention, and at six-week follow-up.","conditions":["HIV","HIV Treatment"],"keywords":["South Africa","HIV","Treatment adherence","Visual tools"],"interventions":[{"type":"BEHAVIORAL","name":"B-OK Bead Bottles Intervention (delivered in person)"},{"type":"BEHAVIORAL","name":"B-OK Bottles Intervention (delivered by video)"},{"type":"BEHAVIORAL","name":"Control"}],"enrollment":600,"startDate":"2026-07-27","completionDate":"2027-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18 years or older\n* Residing in Gauteng\n* Able to understand and communicate in English or another study-supported language\n* Willing to attend an in-person study visit at the HE2RO offices\n* Willing to provide contact details for follow-up at six weeks\n\nExclusion Criteria:\n\n* Unwilling or unable to provide written informed consent for study participation","locations":[{"facility":"Health Economics and Epidemiology Research Office (HE2RO), University of the Witwatersrand","city":"Johannesburg","state":"Gauteng","country":"South Africa","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Divya Pandey, PhD","phone":"6123230324","email":"Divya.Pandey@PennMedicine.upenn.edu"},{"name":"Teniola Egbe, MPH, MBE","phone":"215-898-2939","email":"tegbe@pennmedicine.upenn.edu"}],"primaryOutcomes":["Accuracy of beliefs about ART effectiveness (composite), post-intervention"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":[],"locationSlugs":["johannesburg-south-africa"],"enrichment":{"headline":"Not a traditional drug phase: B-OK Bead Bottles Intervention (delivered in person) for HIV","inPlainEnglish":"Consistent use of antiretroviral therapy (ART) is essential for achieving suppression among people with HIV (PWH). Yet despite improvements in access to ART and improving viral suppression rates, an estimated one-third of PWH globally do not take ART as prescribed, thus allowing the virus to remain detectable and transmissible.","whoItsFor":["Ages 18 Years to any","Aged 18 years or older","Residing in Gauteng","Willing to provide contact details for follow-up at six weeks"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are B-OK Bead Bottles Intervention (delivered in person), B-OK Bottles Intervention (delivered by video), or Control. The registry lists allocation as randomized. Consistent use of antiretroviral therapy (ART) is essential for achieving suppression among people with HIV (PWH).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 600 people at Johannesburg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.531Z"},{"nctId":"NCT07704918","title":"Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma","officialTitle":"Lipid Lowering Therapy for Atherosclerotic Disease in Melanoma Patients Receiving Immune Checkpoint Inhibitors","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood. In this study, melanoma patients receiving ICIs for the first time will undergo a coronary computed tomography angiography (CCTA) scan. CCTA results will be analyzed by the FDA-approved Cleerly TM image analysis pipeline. Patients with disease in their heart arteries will be randomized to usual care or aggressive lipid lowering therapy. Those in the aggressive lipid lowering therapy arm will be seen by a cardiologist and placed on standard lipid lowering medications with a goal of achieving an LDL-C ≤ 55mg/dL. Follow-up CCTA scans will occur at 12-month and 24-month timepoints. The primary outcome of interest will be differences in LDL-C levels between the two arms at the 12-month timepoint. The secondary outcome of interest will be the differences in total plaque volume between the two arms at the 12-month timepoint.","conditions":["Melanoma"],"keywords":["atherosclerosis","coronary artery disease","coronary atherosclerosis"],"interventions":[{"type":"DRUG","name":"Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran)"}],"enrollment":40,"startDate":"2026-10-19","completionDate":"2027-12","sex":"ALL","minAge":"55 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Be a male aged ≥55 years or a female aged ≥65 years.\n* For those able to bear children, documentation or report of menopausal status via approximate last menstrual period or hysterectomy due to contraindication of pregnancy for the CCTA procedure. Those without documentation or report of menopausal status require a negative urine pregnancy test (serum pregnancy test will only be done if needed to confirm an ambiguous or positive urine test).\n* 5\\. Have a melanoma diagnosis without prior course(s) of ICI use and planning to start (or currently on) first course of ICI therapy (PD-1, PD-L1, CTLA-4, LAG3). ICI start can occur prior to consent (up to 90 days prior to eligibility CCTA) as long as it is first exposure. ICI therapy can be received as standard of care or other trial treatment for their cancer.\n* Plaque stage ≥ 1 on screening CCTA.\n\nExclusion Criteria:\n\n* Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator.\n* Meeting any of the standard CCTA contraindications listed below:\n* Allergy to iodinated contrast or history of contrast-induced nephropathy\n* Renal insufficiency (eGFR \\< 45 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) or Modification of Diet in Renal Disease (MDRD) equation). A current eGFR value (collected/calculated within 3 months prior to signing the consent form or at screening) is required at baseline.\n* Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute). EKG must be performed within 1 year prior to signing the consent form or at screening.\n* Hemodynamic instability\n* Weight \\> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower\n* Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment\n* Pregnancy\n* Inability to hold breath for \\> 10 seconds\n* Contraindication to dosing with beta blocker as needed or nitroglycerin prior to CCTA procedure\n* Inability to cooperate with scan acquisition and/or breath-hold instructions\n* Any other factor that, in the opinion of the investigator, would increase participant risk or increase the chance of an uninterpretable CCTA\n* If a patient's fast LDL-C is \\> 190 mg/dL, this is consistent with underlying familial hypercholesterolemia, and they will not be eligible for the study. A current value must be collected within 90 days prior to signing the consent form or at screening.\n* If a patient's CCTA demonstrates previously undiagnosed obstructive coronary disease, they will not be eligible for the study. Obstructive disease will be defined as \\>50% obstruction in the left main coronary artery, or \\>70% obstruction elsewhere in the coronary tree.","locations":[{"facility":"University of Colorado Hospital","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zackry Morgan","phone":"720-848-5494","email":"zackry.morgan@cuanschutz.edu"}],"primaryOutcomes":["Mean change in LDL-C from baseline to 12 months"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["aurora-colorado"],"enrichment":{"headline":"Not a traditional drug phase: testing Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran) for Melanoma","inPlainEnglish":"Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma. These are standard therapy for melanoma, but long-term side effects on disease in the heart arteries is poorly understood.","whoItsFor":["Ages 55 Years to any","Provision to sign and date the consent form","Stated willingness to comply with all study procedures and be available for the duration of the study","Be a male aged ≥55 years or a female aged ≥65 years","Plaque stage ≥ 1 on screening CCTA"],"whoShouldSkip":["Any prior major cardiovascular event, defined as myocardial infarction, stroke, coronary revascularization, or other major cardiovascular event determined to be significant by the principal investigator","Meeting any of the standard CCTA contraindications listed below:","Allergy to iodinated contrast or history of contrast-induced nephropathy","Active arrhythmia (atrial fibrillation, atrial flutter, frequent premature atrial, or ventricular contractions) with poorly controlled rate (i.e., \\> 80 beats per minute). EKG must be performed within 1 year prior to signing the consent form or at screening","Hemodynamic instability","Weight \\> 400 lbs. (181 kg) or above manufacturer-recommended limit for scanner and table, whichever is lower","Thyroid cancer in the previous five (5) years or planned radioactive iodine treatment"],"whatHappens":"If you join, the listed intervention(s) are Statins (atorvastatin, rosuvastatin, simvastatin, or pravastatin), +/- ezetimibe, +/- PCSK9 inhibitor (alirocumab, evolocumab, inclisiran). The registry lists allocation as randomized. Immune checkpoint inhibitors (ICIs) are a class of medications that are now standard in the treatment of melanoma.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Aurora. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.820Z"},{"nctId":"NCT07705555","title":"A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-004)","officialTitle":"A Randomized, Double-Masked, Multicenter, 3-Arm, Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) MK-8748 Compared With Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person.\n\nThe main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.","conditions":["Diabetic Retinopathy","Macular Edema"],"keywords":["Diabetic Macular Edema (DME)"],"interventions":[{"type":"DRUG","name":"MK-8748"},{"type":"DRUG","name":"Aflibercept"}],"enrollment":960,"startDate":"2026-08-27","completionDate":"2028-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%\n* Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)\n* For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study\n* Has history of stroke (cerebral vascular accident) or myocardial infarction within 180 days to first dose of study intervention\n* Has newly diagnosed or previously untreated diabetes mellitus and initiated oral or injectable anti-diabetic medication within 3 months to first dose of study intervention\n* Has history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening\n* Has any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 90 days of screening\n* Has advanced or uncontrolled glaucoma in the study eye\n* Has any history of retinal detachment or treatment or surgery for retinal detachment in the study eye\n* Has active retinal disease other than the condition under investigation in the study eye\n* Has uncontrolled blood pressure at screening","locations":[{"facility":"Associated Retina Consultants, Ltd ( Site 0084)","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Global Research Management ( Site 0066)","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants Medical Group ( Site 0013)","city":"Sacramento","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Specialists of Colorado ( Site 0068)","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants ( Site 0065)","city":"Manchester","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitreo Retinal Associates ( Site 0042)","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Care Specialists ( Site 0095)","city":"Palm Beach Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Associates of Florida ( Site 0034)","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Retina Institute ( Site 0105)","city":"Wildwood","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Eye Institute ( Site 0113)","city":"Carmel","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates LLC ( Site 0024)","city":"Lenexa","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Atlantic Retina ( Site 0062)","city":"Hagerstown","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Specialists ( Site 0074)","city":"Towson","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mississippi Retina Associates, P.A. ( Site 0061)","city":"Madison","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Envision Ocular, LLC ( Site 0039)","city":"Bloomfield","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mid Atlantic Retina ( Site 0048)","city":"Cherry Hill","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Western NY, PC ( Site 0038)","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Carolina Retina Associates ( Site 0064)","city":"Wake Forest","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute ( Site 0087)","city":"Bluffton","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palmetto Retina Center ( Site 0063)","city":"Florence","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute ( Site 0022)","city":"Mt. Pleasant","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palmetto Retina Center ( Site 0014)","city":"West Columbia","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeastern Retina Associates PC ( Site 0071)","city":"Johnson City","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southeastern Retina Associates PC ( Site 0018)","city":"Knoxville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Retina Associates ( Site 0008)","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas ( Site 0001)","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Retina Associates ( Site 0080)","city":"San Marcos","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas ( Site 0029)","city":"Schertz","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants ( Site 0104)","city":"Charleston","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Zambrano ( Site 0402)","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eyeclinic Albury-Wodonga ( Site 2204)","city":"Albury","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marsden Eye Specialists ( Site 2200)","city":"Parramatta","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Strathfield Retina Clinic ( Site 2202)","city":"Strathfield","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sydney Retina Clinic and Day Surgery ( Site 2203)","city":"Sydney","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bristol Eye Hospital ( Site 0902)","city":"Bristol","state":"Bristol, City of","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["gilbert-arizona","glendale-california","sacramento-california","denver-colorado","manchester-connecticut","gainesville-florida","palm-beach-gardens-florida","tampa-florida","wildwood-florida","carmel-indiana","lenexa-kansas","hagerstown-maryland","towson-maryland","madison-mississippi","bloomfield-new-jersey","cherry-hill-new-jersey","rochester-new-york","wake-forest-north-carolina","bluffton-south-carolina","florence-south-carolina","mt-pleasant-south-carolina","west-columbia-south-carolina","johnson-city-tennessee","knoxville-tennessee","austin-texas","bellaire-texas","san-marcos-texas","schertz-texas","charleston-west-virginia","caba-argentina","albury-australia","parramatta-australia","strathfield-australia","sydney-australia","bristol-united-kingdom"],"enrichment":{"headline":"Phase 3: testing MK-8748 for Diabetic Retinopathy","inPlainEnglish":"Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%","Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)","For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-8748, or Aflibercept. The registry lists allocation as randomized. Researchers are looking for new ways to treat diabetic macular edema (DME).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 960 people at 35 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.143Z"},{"nctId":"NCT07705607","title":"A Clinical Trial of MK-8748 Compared to Aflibercept in Participants With Diabetic Macular Edema (MK-8748-005)","officialTitle":"A Randomized, Double-Masked, Multicenter, 3-Arm, Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal (IVT) MK-8748 Compared With Aflibercept (2 mg) in Participants With Diabetic Macular Edema (DME)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME. An available standard (usual) treatment for DME is aflibercept. However, standard treatments such as aflibercept may not work for every person.\n\nThe main goal of this trial is to learn if MK-8748 works as well as aflibercept to treat DME.","conditions":["Diabetic Retinopathy","Macular Edema"],"keywords":["Diabetic Macular Edema (DME)"],"interventions":[{"type":"DRUG","name":"MK-8748"},{"type":"DRUG","name":"Aflibercept"}],"enrollment":1104,"startDate":"2026-09-25","completionDate":"2028-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%\n* Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)\n* For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or has renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study\n* Has history of stroke (cerebral vascular accident) or myocardial infarction within 180 days to first dose of study intervention\n* Has newly diagnosed or previously untreated diabetes mellitus and initiated oral or injectable anti-diabetic medication within 3 months to first dose of study intervention\n* Has history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening\n* Has any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy in the study eye within 90 days of screening\n* Has advanced or uncontrolled glaucoma in the study eye\n* Has any history of retinal detachment or treatment or surgery for retinal detachment in the study eye\n* Has active retinal disease other than the condition under investigation in the study eye\n* Has uncontrolled blood pressure at screening","locations":[{"facility":"South Coast Retina Center ( Site 0121)","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Group of New England ( Site 0101)","city":"Waterford","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Retina Institute ( Site 0035)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Vitreous Associates of Florida ( Site 0036)","city":"St. Petersburg","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Retina and Macular Disease ( Site 0047)","city":"Winter Haven","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Associated Vitreoretinal and Uveitis Consultants ( Site 0099)","city":"Carmel","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolfe Eye Clinic ( Site 0044)","city":"West Des Moines","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cumberland Valley Retina Consultants ( Site 0003)","city":"Hagerstown","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina-Vitreous Surgeons of Central NY ( Site 0021)","city":"Liverpool","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Carolina Retina Associates ( Site 0122)","city":"Greenville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Graystone Eye ( Site 0059)","city":"Hickory","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Retina Specialists ( Site 0049)","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palmetto Retina Center ( Site 0073)","city":"Aiken","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute ( Site 0090)","city":"Beaufort","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charleston Neuroscience Institute ( Site 0076)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of South Carolina ( Site 0026)","city":"Ladson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina ( Site 0051)","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates ( Site 0055)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Texas - Katy/Cinco Ranch ( Site 0100)","city":"Katy","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Center of Texas ( Site 0096)","city":"Southlake","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Mean Change in Best-Corrected Visual Acuity (BCVA) (Early Treatment of Diabetic Retinopathy Study [ETDRS] Letters) From Baseline to Year 1"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["long-beach-california","waterford-connecticut","orlando-florida","st-petersburg-florida","winter-haven-florida","carmel-indiana","west-des-moines-iowa","hagerstown-maryland","liverpool-new-york","greenville-north-carolina","hickory-north-carolina","winston-salem-north-carolina","aiken-south-carolina","beaufort-south-carolina","charleston-south-carolina","ladson-south-carolina","arlington-texas","fort-worth-texas","katy-texas","southlake-texas"],"enrichment":{"headline":"Phase 3: testing MK-8748 for Diabetic Retinopathy","inPlainEnglish":"Researchers are looking for new ways to treat diabetic macular edema (DME). In this trial, researchers want to learn if a trial medicine called MK-8748 can treat DME.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has Type 1 or Type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%","Has a decrease in vision in the study eye determined by the Investigator to be primarily the result of diabetic macular edema (DME)","For participants who are treatment-naïve for DME, the diagnosis must have been made within 9 months of screening. For all treatment-experienced participants, the first treatment should have been no longer than 3 years prior to the Screening visit"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-8748, or Aflibercept. The registry lists allocation as randomized. Researchers are looking for new ways to treat diabetic macular edema (DME).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,104 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.143Z"},{"nctId":"NCT07705737","title":"Rademikibart IV for Acute Asthma and COPD Exacerbation","officialTitle":"A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Connect Biopharm LLC","sponsorClass":"INDUSTRY","summary":"A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation","conditions":["Asthma Acute","COPD Exacerbation Acute"],"keywords":["Acute exacerbation","Asthma","Asthma exacerbation","CBP-201","Rademikibart","Connect Biopharma","COPD exacerbation","COPD acute","COPD","COPD flare","Asthma attack"],"interventions":[{"type":"DRUG","name":"Rademikibart"}],"enrollment":40,"startDate":"2026-08-21","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria - Asthma cohort\n\n* Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a.\n* Physician-diagnosed asthma\n* Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.\n* Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.\n* Participants in a stable condition, must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.\n* Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.\n* Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.\n* Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.\n* FEV1 ≥30% predicted.\n\nExclusion Criteria - Asthma cohort\n\n* Regular use of immunosuppressive medication.\n* Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.\n* Current or former smoker, with a smoking history of ≥5 pack-years if \\<30 years old or ≥10 pack-years if ≥30 years old\n* COPD and other clinically significant pulmonary disease other than asthma.\n* Known or suspected history of immunosuppression.\n* History of known immunodeficiency disorder or hepatitis B or C.\n* History of alcohol abuse and/or drug abuse.\n* Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix or other malignancies treated with apparent success with curative therapy.\n* Female participant who is pregnant, lactating or breast-feeding.\n* Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines.\n* Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.\n* Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.\n* Participants that have been recently treated with bronchial thermoplasty.\n* Recent receipt of any investigational nonbiologic drug.\n* A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population.\n\nInclusion Criteria - COPD cohort\n\n* Body weight of ≥45 kg and BMI ≤45 kg/m2\n* Physician-diagnosed COPD\n* Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.\n* Participants in a stable condition must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.\n* Current or former smoker with a history of smoking of ≥10 pack-years.\n* Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.\n* Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.\n* Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.\n\nExclusion Criteria - COPD cohort\n\n* Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, whichever is longer.\n* Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.\n* Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.\n* Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.\n* Transient ischemic attack or stroke \\<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \\<6 months from Screening Visit.\n* Known or suspected history of immunosuppression.\n* History of known immunodeficiency disorder or hepatitis B or C.\n* History of alcohol abuse and/or drug abuse.\n* Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.\n* Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for \\>15 hours a day.\n* Participants on long-term macrolide.\n* Current acute COPD exacerbation for which SoC was started \\>48 hours prior to Screening.\n* A recent chest X-ray or computed tomography scan reveals evidence of clinically significant abnormalities or pulmonary infection.\n* Female participant who is pregnant, lactating or breast-feeding.\n* Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer.\n* Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer.\n* Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial.\n\nThe above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","locations":[{"facility":"Columbus Clinical Services, LLC","city":"Miami","state":"Florida","country":"United States","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Pharmax Research of South Florida, Inc.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University- Cardiovascular Imaging and Clinical Research Core Laboratory","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Radha Adivikolanu","phone":"213-522-7990","email":"clinical209@connectpharm.com"}],"primaryOutcomes":["Change from baseline in post-BD FEV1"],"hasResults":false,"conditionSlugs":["asthma","copd"],"drugSlugs":[],"locationSlugs":["miami-florida","st-louis-missouri"],"enrichment":{"headline":"Phase 2: testing Rademikibart for Asthma Acute","inPlainEnglish":"A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation","whoItsFor":["Ages 18 Years to 85 Years","Body weight of ≥40 kg and body-mass index (BMI) ≤45 kg/m2 at SV1a","Physician-diagnosed asthma","Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication","Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids","Participants in a stable condition, must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb","Current acute asthma exacerbation requiring an urgent healthcare visit for treatment","Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation"],"whoShouldSkip":["Regular use of immunosuppressive medication","Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension","Current or former smoker, with a smoking history of ≥5 pack-years if \\<30 years old or ≥10 pack-years if ≥30 years old","COPD and other clinically significant pulmonary disease other than asthma","Known or suspected history of immunosuppression","History of known immunodeficiency disorder or hepatitis B or C","History of alcohol abuse and/or drug abuse"],"whatHappens":"If you join, the listed intervention(s) are Rademikibart. The registry lists allocation as na. A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.347Z"},{"nctId":"NCT07706244","title":"Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care","officialTitle":"A Prospective Cohort Study Comparing Preoperative Anxiety and One-Year Patient-Reported Outcomes Between Enhanced Recovery After Surgery and Conventional Care in Orthopedic Surgery Patients","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Buddhist Tzu Chi General Hospital","sponsorClass":"OTHER","summary":"This study investigates whether an Enhanced Recovery After Surgery (ERAS) program can help orthopedic surgery patients feel less anxious before their operation and recover better one year after surgery, compared to conventional (standard) surgical care.\n\nPatients who undergo orthopedic surgery, such as joint replacement, often experience significant anxiety before the operation. While ERAS programs, which combine patient education, pain management, and early mobilization, have been shown to shorten hospital stays and reduce complications, less is known about whether they also reduce preoperative anxiety and lead to better long-term outcomes reported by patients themselves.\n\nIn this prospective cohort study, patients receiving ERAS care will be compared with patients receiving conventional care. Preoperative anxiety will be measured using a validated questionnaire (APAIS). Clinical recovery during hospitalization, including length of stay, pain scores, and opioid use, will also be recorded. Patients will then be followed for one year to assess their quality of life (EQ-5D-5L) and their own impression of overall improvement (Patient Global Impression of Change).\n\nThe goal of this study is to determine whether ERAS not only improves short-term surgical recovery, but also reduces preoperative anxiety and leads to better long-term, patient-centered outcomes.","conditions":["Preoperative Anxiety","Orthopedic Surgery","Patient Reported Outcome (PRO)"],"keywords":["Enhanced Recovery After Surgery","ERAS","APAIS","EQ-5D-5L","Patient Global Impression of Change","Quality of Life","Cohort Study","Perioperative Care"],"interventions":[{"type":"OTHER","name":"Enhanced Recovery After Surgery (ERAS) pathway"},{"type":"OTHER","name":"Conventional care group"}],"enrollment":220,"startDate":"2025-11-01","completionDate":"2027-11-01","sex":"ALL","minAge":"20 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion Criteria:\n\n  1. Age \\>= 20 years.\n  2. Hospitalized patients scheduled for elective major orthopedic surgery (such as total knee arthroplasty, total hip arthroplasty, or spinal surgery).\n  3. Possess sufficient language comprehension and expression skills to complete interviews and questionnaires in Mandarin, Taiwanese, Hakka, or English.\n  4. Agree to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients requiring immediate management due to emergency or traumatic urgent surgery.\n2. Diagnosed by a physician with significant cognitive impairment, delirium, or severe mental illness resulting in the inability to complete evaluation and follow-up.\n3. Severe and unstable medical conditions (such as ASA-V, shock, or requiring long-term intensive care treatment).\n4. Anticipated requirement for intensive care unit (ICU) admission postoperatively.\n5. Concurrent participation in other clinical trials or intervention studies that would affect anxiety or functional outcomes.\n6. Patients for whom follow-up up to 12 months is inconvenient or difficult during the study period.","locations":[{"facility":"Hualien Tzu Chi Hospital","city":"Hualien City","state":"Hualien County","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jing-Ru Wu, MSN, RN;PhD Student","phone":"+886-922095954","email":"113330117@gms.tcu.edu.tw"}],"primaryOutcomes":["Preoperative Anxiety (APAIS Score)","1-Year Patient-Reported Quality of Life (EQ-5D-5L Index)","EQ-VAS Self-Rated Health Score","Time to First Out-of-Bed Mobilization"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["hualien-city-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: Enhanced Recovery After Surgery (ERAS) pathway for Preoperative Anxiety","inPlainEnglish":"This study investigates whether an Enhanced Recovery After Surgery (ERAS) program can help orthopedic surgery patients feel less anxious before their operation and recover better one year after surgery, compared to conventional (standard) surgical care. Patients who undergo orthopedic surgery, such as joint replacement, often experience significant anxiety before the operation.","whoItsFor":["Ages 20 Years to 100 Years","who can join:","Hospitalized patients scheduled for elective major orthopedic surgery (such as total knee arthroplasty, total hip arthroplasty, or spinal surgery)","Possess sufficient language comprehension and expression skills to complete interviews and questionnaires in Mandarin, Taiwanese, Hakka, or English"],"whoShouldSkip":["Patients requiring immediate management due to emergency or traumatic urgent surgery","Diagnosed by a physician with significant cognitive impairment, delirium, or severe mental illness resulting in the inability to complete evaluation and follow-up","Severe and unstable medical conditions (such as ASA-V, shock, or requiring long-term intensive care treatment)","Anticipated requirement for intensive care unit (ICU) admission postoperatively","Concurrent participation in other clinical trials or intervention studies that would affect anxiety or functional outcomes","Patients for whom follow-up up to 12 months is inconvenient or difficult during the study period"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 220 people at Hualien City. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.347Z"},{"nctId":"NCT07706478","title":"Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients","officialTitle":"Effectiveness and Underlying Mechanisms of an Innovative Treatment Program for Persistent Mood and Anxiety Conditions","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Senz","sponsorClass":"OTHER","summary":"Ketamine-Assisted Psychotherapy (KAP) is an innovative treatment that combines intravenous ketamine with psychotherapy in a carefully monitored clinical setting. At Senz, this treatment is being evaluated in an open-label clinical trial for individuals with persistent depression who have not responded sufficiently to previous treatments. The combination of ketamine, psychological support, and integration sessions aims to promote emotional processing, psychological flexibility, and lasting therapeutic change.","conditions":["Treatment Resistant Depression"],"keywords":["KAP","TRD","Depression","IV ketamine"],"interventions":[],"enrollment":120,"startDate":"2025-06-01","completionDate":"2033-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (18 years and older)\n* TRD\n* A MADRS score above the established clinical cut-off, indicating clinically significant depressive symptoms\n* Insufficient response to at least two adequate antidepressant treatment trials and one evidence-based psychotherapy, or failure to achieve adequate improvement following at least three consecutive treatment steps in accordance with the Dutch Multidisciplinary Guideline for Depression\n\nExclusion Criteria:\n\n* Current substance use disorder or recent illicit drug use\n* Substance use disorder not in remission for at least 3 months\n* Inability to abstain from alcohol for 24 hours before and after treatment\n* Acute suicidality\n* Current or past psychotic disorder\n* Significant neurological disorders (e.g., epilepsy, elevated intracranial pressure)\n* Uncontrolled hypertension or medical conditions associated with increased cardiovascular or cerebrovascular risk (e.g., aneurysms, recent myocardial infarction or intracerebral hemorrhage)\n* Significant bladder disease (e.g., cystitis)\n* Severe hepatic impairment\n* Pregnancy, breastfeeding, or ongoing IVF treatment\n* Extreme underweight or obesity where treatment is deemed medically unsafe Inability to arrange an accompanying adult for transport and support after treatment","locations":[{"facility":"SENZ","city":"Doorn","state":"Utrecht","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rutger Engels, dr","phone":"+31 343 235300","email":"r.engels@senzggz.nl"},{"name":"karlijn kindt, dr","phone":"+31343 235300","email":"k.kindt@senzggz.nl"}],"primaryOutcomes":["Beck Depression Inventory"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["doorn-netherlands"],"enrichment":{"headline":"Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients","inPlainEnglish":"Ketamine-Assisted Psychotherapy (KAP) is an innovative treatment that combines intravenous ketamine with psychotherapy in a carefully monitored clinical setting. At Senz, this treatment is being evaluated in an open-label clinical trial for individuals with persistent depression who have not responded sufficiently to previous treatments.","whoItsFor":["Ages 18 Years to 70 Years","Adults (18 years and older)","A MADRS score above the established clinical cut-off, indicating clinically significant depressive symptoms"],"whoShouldSkip":["Current substance use disorder or recent illicit drug use","Substance use disorder not in remission for at least 3 months","Inability to abstain from alcohol for 24 hours before and after treatment","Current or past psychotic disorder","Significant neurological disorders (e.g., epilepsy, elevated intracranial pressure)","Uncontrolled hypertension or medical conditions associated with increased cardiovascular or cerebrovascular risk (e.g., aneurysms, recent myocardial infarction or intracerebral hemorrhage)","Significant bladder disease (e.g., cystitis)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Doorn. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.793Z"},{"nctId":"NCT07706543","title":"Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)","officialTitle":"Evaluation of a Therapeutic Patient Education Program for Discharge (ETPsh) by Nurses in a French Hospital Setting Among Patients With Heart Failure","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Hospital, Clermont-Ferrand","sponsorClass":"OTHER","summary":"Heart failure affects 2.3% of the adult French population. Readmission within 30 days doubles the risk of early death within the following 30 to 60 days, as well as the risk of rehospitalization over the subsequent two years. Incorporating nurse-led discharge education can significantly reduce readmissions for heart failure as well as all-cause readmissions. Drawing on practices from English-speaking countries and Switzerland regarding patient discharge education at hospital, we propose to evaluate a discharge education program in the French hospital setting for patients with heart failure.\n\nThe objective of this multicenter before-and-after study is to evaluate the impact of a nurse-led discharge education delivered at hospital on the quality of the care pathway for patients with heart failure, assessed 30 days after hospital discharge. The primary outcome is the reduction in 30-day unplanned all-cause hospital readmissions, including emergency department visits. An informal (non-professional) caregiver may also be enrolled in the study if identified by the patient and present during the hospitalization.\n\nPatients enrolled before implementation of the discharge education will constitute the control group (standard therapeutic patient education group). They will receive usual hospital care, including educational sessions throughout hospitalization covering the disease, treatments, and self-care, as well as a follow-up consultation with a nurse 30 days after hospital discharge. This usual care is referred to as standard therapeutic patient education and does not include a structured therapeutic patient education intervention at hospital discharge.\n\nPatients receiving the discharge education will constitute the intervention group (standard therapeutic patient education with discharge education group). They will receive the same usual care (i.e., standard therapeutic patient education and the 30-day post-discharge nurse follow-up consultation), supplemented by the nurse-led discharge education intervention during their hospitalization.\n\nTo minimize the risk of contamination (diffusion bias), the control group will be enrolled and complete follow-up before nurses receive training in the discharge education intervention.","conditions":["Heart Failure"],"keywords":["Heart failure","Discharge education","Nurses","Therapeutic education as topic","Readmission"],"interventions":[{"type":"BEHAVIORAL","name":"Nurse-led discharge education"}],"enrollment":412,"startDate":"2026-10-29","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged 18 years old or more,\n* Fluent in spoken and written French,\n* Willing to participate in the study,\n* Hospitalized for heart failure in one of the participating centers for at least 2 days,\n* Affiliated with a French social security scheme\n* Discharged either to home or transferred to a Medical and Rehabilitation Care unit.\n\nExclusion Criteria:\n\n* Hospitalized for a reason other than heart failure,\n* Previously included in the study during a prior hospitalization,\n* Presenting with identified cognitive impairment,\n* In a situation deemed inappropriate by the care team (end of life),\n* Living in an institutional setting,\n* Pregnant women,\n* Breastfeeding women,\n* Under legal protective measures,\n* Enrolled in another interventional research study that may interfere with the results of the present study, according to the investigator's judgment.","locations":[{"facility":"CHU Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Poitiers","city":"Poitiers","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CH Vichy","city":"Vichy","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Laclautre","phone":"0473754963","email":"promo_interne_drci@chu-clermontferrand.fr"}],"primaryOutcomes":["Unplanned all-cause rehospitalizations, including emergency department visits."],"hasResults":false,"conditionSlugs":["als","heart-failure"],"drugSlugs":[],"locationSlugs":["clermont-ferrand-france","poitiers-france","vichy-france"],"enrichment":{"headline":"Not a traditional drug phase: Nurse-led discharge education for Heart Failure","inPlainEnglish":"Heart failure affects 2.3% of the adult French population. Readmission within 30 days doubles the risk of early death within the following 30 to 60 days, as well as the risk of rehospitalization over the subsequent two years.","whoItsFor":["Ages 18 Years to any","Patient aged 18 years old or more,","Fluent in spoken and written French,","Hospitalized for heart failure in one of the participating centers for at least 2 days,","Affiliated with a French social security scheme","Discharged either to home or transferred to a Medical and Rehabilitation Care unit"],"whoShouldSkip":["Hospitalized for a reason other than heart failure,","Previously included in the study during a prior hospitalization,","Presenting with identified cognitive impairment,","In a situation deemed inappropriate by the care team (end of life),","Living in an institutional setting,","Breastfeeding women,","Under legal protective measures,"],"whatHappens":"If you join, the listed intervention(s) are Nurse-led discharge education. The registry lists allocation as randomized. Heart failure affects 2.3% of the adult French population.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 412 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.431Z"},{"nctId":"NCT07707102","title":"Advancing Skills Through Consultation, Education, and Novel Technologies","officialTitle":"Increasing the Reach of Evidence-Based PTSD Treatment: Development and Clinical Trial of Artificial Intelligence (AI)-Facilitated, Web-Based Written Exposure Therapy Training","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"The University of Texas Health Science Center at San Antonio","sponsorClass":"OTHER","summary":"This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD). There are a number of evidence-based treatments for posttraumatic stress disorder (PTSD). However, most behavioral health providers have not received training in these PTSD treatments and do not offer them regularly to their patients.\n\nThe researchers hope to learn about the optimal way to train behavioral providers in this type of treatment. This study is designed to determine the comparative effectiveness of different training strategies on key outcomes such as how much competency providers develop in the therapy and to how many patients they deliver the therapy. This study will help the researchers understand if we can help more providers learn to competently delivery Written Exposure Therapy by using strategies that are more convenient and cost less money, including web-based and AI-facilitated training supports. This study will also help us learn which training strategies work best for which providers so that in the future we can make personalized training recommendations.","conditions":["PTSD - Post Traumatic Stress Disorder"],"keywords":["Written Exposure Therapy","AI-facilitated training"],"interventions":[{"type":"BEHAVIORAL","name":"Live workshop"},{"type":"BEHAVIORAL","name":"AI-enhanced Web-based training"},{"type":"BEHAVIORAL","name":"Consultation video calls"},{"type":"BEHAVIORAL","name":"TherapyTrainer"}],"enrollment":300,"startDate":"2026-08-20","completionDate":"2028-08-31","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. mental health provider;\n2. serves U.S. veterans and/or U.S. service members with PTSD;\n3. willing to participate in either live or web-based training.\n\nExclusion Criteria:\n\n1\\. has already completed formal training in Written Exposure Therapy","locations":[{"facility":"University of Texas Health Science Center at San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stefanie Losavio, PhD","phone":"(210) 562-6714","email":"ASCENT@uthscsa.edu"}],"primaryOutcomes":["Provider WET Competency"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["san-antonio-texas"],"enrichment":{"headline":"Not a traditional drug phase: Live workshop for PTSD - Post Traumatic Stress Disorder","inPlainEnglish":"This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD). There are a number of evidence-based treatments for posttraumatic stress disorder (PTSD).","whoItsFor":["mental health provider;","serves U.S. veterans and/or U.S. service members with PTSD;"],"whoShouldSkip":["1\\. has already completed formal training in Written Exposure Therapy"],"whatHappens":"If you join, the listed intervention(s) are Live workshop, AI-enhanced Web-based training, or Consultation video calls. The registry lists allocation as randomized. This research study tests strategies to train behavioral health providers in Written Exposure Therapy (WET), an evidence-based treatment for posttraumatic stress disorder (PTSD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at San Antonio. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.407Z"},{"nctId":"NCT07707635","title":"IBS-Oriented CDED Versus Low FODMAP Diet for Irritable Bowel Syndrome","officialTitle":"Open-Label, Randomized Controlled Study to Assess the Efficacy of a Modified Crohn's Disease Exclusion Diet (CDED) Versus Low FODMAP Diet for Managing Non-Constipation Irritable Bowel Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Ariel University","sponsorClass":"OTHER","summary":"Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M). Most patients report food-related symptom exacerbation, making dietary intervention a cornerstone of treatment. While the low-FODMAP diet (LFD) is widely used to reduce fermentable carbohydrates and alleviate symptoms, it may negatively affect microbial diversity and lacks anti-inflammatory effects. In contrast, the Crohn's Disease Exclusion Diet (CDED), developed for Crohn's disease, has demonstrated the ability to reduce intestinal inflammation, improve barrier function, and promote a favorable microbiota profile. These mechanisms may be relevant and beneficial in IBS, but have yet to be studied in this population.\n\nObjectives: To compare the efficacy of a modified CDED to the LFD for the treatment of non-constipated IBS symptoms, Hypothesis: A modified CDED will be at least as effective as the LFD in alleviating non-constipation IBS symptoms, stool consistency, quality of life, and psychological distress, while demonstrating superior effects on markers of low-grade inflammation, gut microbiota composition, and intestinal permeability.\n\nMethods: This is a single-center, open-label, randomized study to be conducted at the Gastroenterology Department of Sheba Medical Center. 136 adults diagnosed with Rome IV-defined IBS-D or IBS-M and an IBS Symptom Severity Score (IBS-SSS) ≥175 will be randomized 1:1 to receive either a modified CDED or the LFD for 6 weeks. Accounting for a 10% dropout rate, the total sample size will be 150.\n\nFollowing a 14-day screening period, eligible participants will undergo data collection at baseline, week 3 and week 6. Visit 1 (screening) will be conducted on-site; visits 2-4 will be remote. Participants will complete daily symptom diaries \\[Bristol Stool Form Scale (BSFS) and GI Visual Analogue Scale (VAS)\\], and weekly IBS-SSS. Validated questionnaires assessing psychological distress, somatization, extraintestinal symptoms, and quality of life will be administered at each time point.\n\nStool samples will be collected at baseline, week 3, and week 6. Fecal calprotectin (FC) and α1-Antitrypsin (A1AT) will be analyzed as markers of intestinal inflammation and permeability. Microbiota analysis will be conducted using 16S rRNA gene sequencing, with evaluation of microbial diversity, taxonomic shifts, and associations with clinical and biological outcomes.\n\nSignificance: This is the first study to evaluate the modified CDED as a dietary intervention for the treatment of IBS. It may offer a novel, inflammation-targeted alternative treatment for IBS.","conditions":["Irritable Bowel Syndrome (IBS)"],"keywords":["Crohn's Disease Exclusion Diet (CDED)","Low FODMAP Diet","Diet Therapy","Gut Microbiota","Intestinal Permeability","Fecal Calprotectin","Alpha-1 Antitrypsin","IBS-D","IBS-M"],"interventions":[{"type":"OTHER","name":"Modified Crohn's Disease Exclusion Diet (CDED)"},{"type":"OTHER","name":"Low FODMAP Diet"}],"enrollment":150,"startDate":"2026-07-19","completionDate":"2028-07-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria.\n* Moderate-to-severe symptoms (IBS-SSS score ≥175).\n* Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics\n\nExclusion Criteria:\n\n* Coexisting GI diseases \\[e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease \\[positive transglutaminase (TTG) serology\\].\n* Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease \\[abnormal Thyroid-Stimulating Hormone (TSH)\\], and bariatric surgery.\n* Recent intestinal resection.\n* Pregnancy or breastfeeding.\n* Known food allergies.\n* Current active eating disorder\n* Participants already following a restrictive diet, including diets that overlap with the interventions in this study, will be excluded to prevent confounding effects on gut microbiota composition and gastrointestinal symptoms, and to ensure consistent baseline conditions. However, individuals who have discontinued such diets at least two to four weeks prior to enrollment may be eligible, allowing for a sufficient dietary washout period to minimize residual effects on the gut microbiota.\n* Currently under obesity management medication treatment.\n* Vegans\n* Use of antibiotics within the 4 weeks prior to enrollment or during the study period.\n* Abnormal hemoglobin levels (for women\\<11.5 gr/dl, for men\\<13 gr/dl)29\n* Baseline CRP≥5","locations":[{"facility":"Sheba Medical Center, Tel Hashomer","city":"Ramat Gan","state":"Tel Aviv","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Keren Hod, RD PhD","phone":"+972-53-2214380","email":"kerenho@ariel.ac.il"},{"name":"Tal Engel, MD","phone":"+972-52-5752211","email":"talengel@gmail.com"}],"primaryOutcomes":["Proportion of participants achieving a clinically meaningful response (≥50-point reduction in IBS Symptom Severity Score [IBS-SSS])"],"hasResults":false,"conditionSlugs":["crohns-disease","ibs"],"drugSlugs":[],"locationSlugs":["ramat-gan-israel"],"enrichment":{"headline":"Not a traditional drug phase: Modified Crohn's Disease Exclusion Diet (CDED) for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden. Recent evidence highlights the role of low-grade inflammation, impaired intestinal permeability and gut microbiota dysbiosis in the pathophysiology of non-constipated IBS (IBS with predominate diarrhea; IBS-D and mixed type IBS; IBS-M).","whoItsFor":["Ages 18 Years to any","Adults, men, and women (≥18 years) are diagnosed with IBS-D or IBS-M according to Rome IV criteria","Moderate-to-severe symptoms (IBS-SSS score ≥175)","Stable use of any IBS-related medications for ≥6 weeks before study enrollment, except for antibiotics"],"whoShouldSkip":["Coexisting GI diseases \\[e.g., Crohn's disease, ulcerative colitis, SIBO, celiac disease \\[positive transglutaminase (TTG) serology\\]","Disease that could explain or influence symptoms or GI function, including diabetes, thyroid disease \\[abnormal Thyroid-Stimulating Hormone (TSH)\\], and bariatric surgery","Recent intestinal resection","Pregnancy or breastfeeding","Known food allergies","Current active eating disorder","Currently under obesity management medication treatment"],"whatHappens":"If you join, the listed intervention(s) are Modified Crohn's Disease Exclusion Diet (CDED), or Low FODMAP Diet. The registry lists allocation as randomized. Background: Irritable Bowel Syndrome (IBS) affects approximately 4.1% of the global population and imposes a significant personal and healthcare burden.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at Ramat Gan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.887Z"},{"nctId":"NCT07708064","title":"Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain","officialTitle":"Testing Just-in-Time Adaptive Interventions (JITAIs) to Prevent Goal Disengagement in Response to Weight Regain","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"ORI Community and Evaluation Services","sponsorClass":"OTHER","summary":"This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. Participants will be randomly assigned to one of two conditions. In one condition, participants will receive brief exercises (e.g., written reflections, videos) sent to through a smartphone app immediately after they regain weight or miss a weigh-in. These exercises will use mindfulness, acceptance, and self-compassion strategies to help participants stay motivated for their long term goals, even when weight regain feels demoralizing. In the comparison condition, participants will receive weekly reminders of standard weight control strategies strategies.","conditions":["Overweight or Obesity"],"keywords":["just-in-time adaptive interventions","weight regain","self-weighing","self-compassion","acceptance-based behavioral treatments","mindfulness","behavioral weight loss"],"interventions":[{"type":"BEHAVIORAL","name":"JITAI Combined with psychological intervention"},{"type":"BEHAVIORAL","name":"Active Control"}],"enrollment":120,"startDate":"2026-07-14","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Ages 18-75 years\n* BMI of 25-50 kg/m2\n* Current weight is 3% lower than their highest weight in the past 3 years\n* Desire to maintain their weight or lose more\n* Ability to engage in PA, as defined as being able to walk two full city blocks without stopping\n* Smartphone and Internet access\n* Successful completion of all enrollment procedures\n* Ability to attend a workshop(s) on a Monday or Tuesday evening\n\nExclusion Criteria:\n\n* History of bariatric surgery\n* History of being diagnosed with an eating disorder\n* Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months\n* Enrolled in another formal weight loss/weight maintenance program\n* Currently taking a GLP-1 medication.","locations":[{"facility":"Oregon Research Institute Community and Evaluation Services","city":"Springfield","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Charlotte Hagerman, PhD","phone":"14109372035","email":"chagerman@ori.org"}],"primaryOutcomes":["State negative affect","State shame","State Motivation","State Self-Efficacy","Current confidence in the effectiveness of weight control behaviors","State self-compassion","State mindfulness","State acceptance","Self-serving interpretation of weight gain","Daily Calorie Tracking (Yes/No)","Daily MVPA","Likelihood of weighing in the following day","Weight change","Intervention acceptability","Calorie Tracking Frequency","Average Weekly MVPA","Frequency of Weighing In"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":[],"locationSlugs":["springfield-oregon"],"enrichment":{"headline":"Not a traditional drug phase: JITAI Combined with psychological intervention for Overweight or Obesity","inPlainEnglish":"This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain. you would be randomly assigned to one of two conditions.","whoItsFor":["Ages 18 Years to 75 Years","Current weight is 3% lower than their highest weight in the past 3 years","Desire to maintain their weight or lose more","Ability to engage in PA, as defined as being able to walk two full city blocks without stopping","Smartphone and Internet access","Successful completion of all enrollment procedures","Ability to attend a workshop(s) on a Monday or Tuesday evening"],"whoShouldSkip":["History of bariatric surgery","History of being diagnosed with an eating disorder","Currently pregnant, breastfeeding, or planning to become pregnant in the next 24 months","Enrolled in another formal weight loss/weight maintenance program","Currently taking a GLP-1 medication"],"whatHappens":"If you join, the listed intervention(s) are JITAI Combined with psychological intervention, or Active Control. The registry lists allocation as randomized. This trial will test the effectiveness of a weight loss maintenance intervention designed to help participants respond more adaptively to weight regain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Springfield. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.824Z"},{"nctId":"NCT07708350","title":"Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Sickle Cell Disease","officialTitle":"A Pilot Trial of Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Sickle Cell Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Daniel Bauer","sponsorClass":"OTHER","summary":"A promising approach for the treatment of genetic diseases is called gene therapy. Gene therapy is a relatively new field of medicine that uses genetic material (mostly deoxyribonucleic acid (DNA)) from the patient to treat his or her own disease. In gene therapy, the investigators introduce new genetic material in order to fix or replace a diseased gene, with the goal of curing the disease. The procedure is similar to a bone marrow transplant, in that the patient's malfunctioning blood stem cells are reduced or eliminated using chemotherapy, but it is different because instead of using a different person's (donor) blood stem cells for the transplant, the patient's own blood stem cells are given back after the new genetic material has been introduced into those cells. This approach has the advantage of eliminating any risk of Graft-Versus-Host Disease (GVHD), reducing the risk of graft rejection, and may also allow less chemotherapy to be utilized for the conditioning portion of the transplant procedure. The method used to fix or replace a diseased gene is called gene editing. A person's own cells are edited using a specialized biological medicine that has been formulated for use in human beings.\n\nFetal hemoglobin (HbF) is a healthy, non-sickling kind of hemoglobin. Investigators have recently discovered a gene called BCL11A that is very important in the control of fetal hemoglobin expression. Increasing the expression of this gene in sickle cell patients could increase the amount of fetal hemoglobin while simultaneously reducing the amount of sickle hemoglobin in their blood, and therefore potentially cure the condition.","conditions":["Sickle Cell Disease","Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)"],"keywords":["gene therapy","stem cell transplant","bone marrow transplant","autologous hematopoietic stem cell transplant","gene editing","hematopoietic stem cell transplant"],"interventions":[{"type":"BIOLOGICAL","name":"autologous bone marrow derived CD34+ HSPCs electroporated with BCL11A enhancer targeting Cas9 ribonucleoprotein"},{"type":"DEVICE","name":"Sequencing Assay for Variant rs114518452"}],"enrollment":5,"startDate":"2026-08-01","completionDate":"2028-12","sex":"ALL","minAge":"13 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of either a) sickle cell disease with genotype HbSS, HbS/B0 thalassemia, HbSD, or HbSO\n2. Age 13-35 years.\n3. Clinically severe disease, defined as: The presence of one or more of the following clinical complications: i) Minimum of two episodes of acute chest syndrome (ACS) in the 2 years before study entry. ii) History of three or more episodes of severe pain events requiring a visit to a medical facility and treatment with parenteral opioids in the 2 years before study entry.\n4. Adequate hematologic parameters including:\n\n   a. White blood cell (WBC) count within the range of 2.5 - 25.0 x 109 /L b. Platelet count within the range of 150 - 700 x 109 /L\n5. Adequate organ function and performance status:\n\n   1. Karnofsky performance status ≥70%\n   2. Serum creatinine \\</=1.5 times the upper limit of normal for age, and calculated creatinine clearance or Glomerular Filtration Rate (GFR) \\</= 60 mL/min/1.73 m2.\n   3. Direct bilirubin ≤ 2.0 mg/dL\n   4. Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) (corrected for hemoglobin), Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC) \\>50% of predicted\n   5. Left ventricular ejection fraction \\>40% or shortening fraction \\>25%\n6. Failure of hydroxyurea therapy due to lack of clinical improvement, inability to tolerate due to side effects (e.g., myelosuppression, gastrointestinal symptoms, or hepatic enzyme elevations) or not clinically indicated (such as in a patient on a chronic transfusion regimen). Clinical criteria (per above) must be met despite taking hydroxyurea for greater than or equal to 6 months, unless not indicated or not tolerated. Patients taking hydroxyurea who still meet all inclusion criteria are eligible for the trial. Hydroxyurea should be discontinued when transfusions prior to gene therapy begin.\n7. Confirmed sickle cell disease diagnosis by molecular genetic testing.\n8. No Human Leukocyte Antigen (HLA) genotypically-identical related appropriate bone marrow donor available.\n9. Parental/guardian/patient signed informed consent.\n10. Willingness to return for follow-up for 15 years.\n\nExclusion Criteria:\n\n1. Subjects who have concomitant condition or illness including, but not limited to:\n\n   1. Uncontrolled infection, such as current febrile illness, infection requiring parenteral antibiotics, or systemic fungal infection.\n   2. Active malignancy.\n   3. Active complication of underlying hemoglobinopathy that would place the patient at unacceptable risk for participation, in the judgment of the Investigators.\n   4. Major surgery in the past 30 days.\n   5. Medical/psychiatric illness/social situations that would limit compliance with study requirements as determined by the treating physician.\n\n      * Contraindication to administration of conditioning medication (busulfan).\n\n3\\. Subjects who have undergone allogeneic or autologous hematopoietic stem cell transplant previously.\n\n4\\. Either or both of the following findings on screening bone marrow aspirate/biopsy: a) diagnosis of myelodysplastic syndrome (MDS) based on morphology and/or cytogenetics (based on WHO definitions) or b) pathogenic mutation in any gene on the Rapid Heme Panel (RHP), a next-generation targeted sequencing clinical assay for hematologic malignancy associated mutations.\n\n5\\. For SCD patients:\n\n1. Severe cerebral vasculopathy (defined by occlusion or stenosis in the circle of Willis; or presence of Moyamoya disease)\n2. Receiving a chronic transfusion regimen for primary or secondary stroke prophylaxis. (Note: patients with a history of abnormal transcranial Doppler (TCD) who have transitioned from transfusions to hydroxyurea for stroke prophylaxis are also not eligible for the study. Most recent TCD must be within one year of screening for patients up to 16 years old.)\n3. History of overt stroke or any neurologic event lasting \\> 24 hours. (Note: patients with imaging evidence of silent stroke but not on a chronic transfusion regimen are not excluded.) 6. Severe iron overload that is deemed to be grounds for exclusion based on the opinion of the Principal Investigator.\n\n   7\\. Known positive Human Immunodeficiency Virus (HIV) serology or HIV nucleic acid testing, or positive serology for Hepatitis C (HCV), Hepatitis B (HBV), or Human T-Lymphotropic Virus (HTLV).\n\n   8\\. Known acute hepatitis or evidence of moderate or severe portal fibrosis or cirrhosis on prior biopsy.\n\n   9\\. Receipt of an investigational study drug or procedure within 90 days of study enrollment.\n\n   10\\. Pregnancy, or breastfeeding in a postpartum female, or absence of adequate contraception for fertile subjects. Females of child-bearing potential must agree to use a medically acceptable method of birth control such as oral contraceptive, intrauterine device, barrier and spermicide, or contraceptive implant/injection from Screening through at least 6 months after drug product infusion. Male subjects must agree to use effective contraception (including condoms) from Screening through at least 6 months after drug product infusion.\n\n   11\\. An assessment by the Investigators that the subject will not comply with the study procedures outlined in the study protocol, or that, as determined by the investigators and/or transplant physician, the subject has any other condition rendering the subject ineligible for Hematopoietic Stem Cell Transplantation (HSCT) or other study procedures.\n\n   12\\. Patients carrying at least one cytosine (C) alternate allele at the SNP site rs114518452, chr2:210530659-210530659 (GRCh38/hg38), where guanine (G) is the reference allele.","locations":[{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emily Morris","phone":"631-355-8724","email":"gene.therapy@childrens.harvard.edu"}],"primaryOutcomes":["Primary engraftment"],"hasResults":false,"conditionSlugs":["als","sickle-cell"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 1: testing autologous bone marrow derived CD34+ HSPCs electroporated with BCL11A enhancer targeting Cas9 ribonucleoprotein for Sickle Cell Disease","inPlainEnglish":"A promising approach for the treatment of genetic diseases is called gene therapy. Gene therapy is a relatively new field of medicine that uses genetic material (mostly deoxyribonucleic acid (DNA)) from the patient to treat his or her own disease.","whoItsFor":["Ages 13 Years to 35 Years","Diagnosis of either a) sickle cell disease with genotype HbSS, HbS/B0 thalassemia, HbSD, or HbSO","Adequate hematologic parameters including:","a. White blood cell (WBC) count within the range of 2.5 - 25.0 x 109 /L b. Platelet count within the range of 150 - 700 x 109 /L","Adequate organ function and performance status:","Karnofsky performance status ≥70%","Serum creatinine \\</=1.5 times the upper limit of normal for age, and calculated creatinine clearance or Glomerular Filtration Rate (GFR) \\</= 60 mL/min/1.73 m2","Direct bilirubin ≤ 2.0 mg/dL"],"whoShouldSkip":["Subjects who have concomitant condition or illness including, but not limited to:","Uncontrolled infection, such as current febrile illness, infection requiring parenteral antibiotics, or systemic fungal infection","Active complication of underlying hemoglobinopathy that would place the patient at unacceptable risk for participation, in the judgment of the Investigators","Major surgery in the past 30 days","Medical/psychiatric illness/social situations that would limit compliance with study requirements as determined by the treating physician","Contraindication to administration of conditioning medication (busulfan)","3\\. Subjects who have undergone allogeneic or autologous hematopoietic stem cell transplant previously"],"whatHappens":"If you join, the listed intervention(s) are autologous bone marrow derived CD34+ HSPCs electroporated with BCL11A enhancer targeting Cas9 ribonucleoprotein, or Sequencing Assay for Variant rs114518452. The registry lists allocation as na. A promising approach for the treatment of genetic diseases is called gene therapy.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 5 people at Boston. Taking part typically means an infusion or injection of a biologic, using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.841Z"},{"nctId":"NCT07708727","title":"Study of an Injectable Regimen of GS-3242 With Lenacapavir Compared to Biktarvy in People New to HIV-1 Treatment","officialTitle":"An Operationally Seamless Phase 2/3 Randomized, Open-label, Active-Controlled Study Evaluating the Safety and Efficacy of an Injectable Regimen of GS-3242 in Combination With Lenacapavir Versus Biktarvy (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Treatment-Naive People With HIV-1","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.\n\nThe goal of Phase 2, Part A is to assess the effectiveness of study drugs GS-3242 plus Lenacapavir (LEN) versus Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF)), in people with HIV-1 (PWH) who are new to treatment. This will be done in Treatment Groups 1, 2 and 3 at Week 35.\n\nThe goal of Phase 2, Part B is to compare the effectiveness of study drugs, GS-3242 and LEN versus B/F/TAF in Groups 4 and 3 at Week 26.\n\nThe goal of Phase 3 is to assess the long-term effectiveness of study drug GS-3242 and LEN versus B/F/TAF, at Week 52.\n\nThe primary objectives of this study are:\n\nPhase 2, Part A: To evaluate the efficacy of intramuscular (IM) GS-3242 plus IM LEN versus B/F/TAF in treatment-naive people with HIV-1 (PWH) in Treatment Groups 1, 2, and 3 at Week 35. Phase 2, Part B: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH in Treatment Groups 4 and 3 at Week 26.\n\nPhase 3: To evaluate the efficacy of IM GS-3242 plus IM LEN versus B/F/TAF in treatment-naive PWH at Week 52.","conditions":["HIV-1-infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"GS-3242 Tablet"},{"type":"DRUG","name":"GS-3242 Injection"},{"type":"DRUG","name":"Lenacapavir Tablet"},{"type":"DRUG","name":"Lenacapavir Injection"},{"type":"DRUG","name":"B/F/TAF"}],"enrollment":700,"startDate":"2026-07-29","completionDate":"2030-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening.\n* Antiretroviral (ARV) treatment-naive, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening.\n\nKey Exclusion Criteria:\n\n* Prior usage of, or exposure to LEN or GS-3242\n* Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.","locations":[{"facility":"Lundquist Inst Biomedical Innovation Harbor-UCLA","city":"Torrance","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yale University; School of Medicine; AIDS Program","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midway Immunology and Research Center","city":"Ft. Pierce","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Floridian Clinical Research, LLC","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Immunology Center, PA","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triple O Research Institute, P.A.","city":"West Palm Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown Infectious Disease Clinic","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Metro Infectious Disease Consultants, P.L.L.C","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"KC care Health Center","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Saint Michael's Medical Center","city":"Newark","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Hope Foundation, Inc,","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Prism Health North Texas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Texas Infectious Diseases Consultants, PA","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Centers for Infectious Disease Associates","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MultiCare Health System - Deaconess Medical Office Building 2","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"McGill University Health Centre","city":"Decarie Montreal","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Québec-Université Laval","city":"Québec","state":"","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICH Study Center GmbH & Co. KG","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Proyecto ACTU","city":"Rio Piedras","state":"PR","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"HOPE Clinical Research","city":"San Juan","state":"PR","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de las Nieves","city":"Granada","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"leadClinicalTrials@gilead.com"}],"primaryOutcomes":["Phase 2: Part A: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 35 as Determined by the United States (US) Food and Drug Administration (FDA) Snapshot Algorithm","Phase 2: Part B: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA Snapshot Algorithm","Phase 3: Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA Snapshot Algorithm"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["torrance-california","new-haven-connecticut","ft-pierce-florida","miami-lakes-florida","orlando-florida","west-palm-beach-florida","atlanta-georgia","decatur-georgia","kansas-city-missouri","newark-new-jersey","bellaire-texas","dallas-texas","fort-worth-texas","spokane-washington","decarie-montreal-canada","qu-bec-canada","hamburg-germany","rio-piedras-puerto-rico","san-juan-puerto-rico","granada-spain"],"enrichment":{"headline":"Phase 2 / Phase 3: testing GS-3242 Tablet for HIV-1-infection","inPlainEnglish":"The study will have two portions: Phase 2 and Phase 3. Phase 2 will further have 2 parts: Part A and Part B.","whoItsFor":["Ages 18 Years to any","HIV-1 ribonucleic acid (RNA) ≥ 500 copies/mL at screening","Antiretroviral (ARV) treatment-who have not tried this kind of treatment before, except for prior use of oral daily pre-exposure prophylaxis (PrEP) or postexposure prophylaxis (PEP) up to 1 month prior to screening"],"whoShouldSkip":["Prior usage of, or exposure to LEN or GS-3242","Prior use of any long-acting parenteral ARV therapy (ART) medications such as monoclonal antibodies or broadly neutralizing antibodies targeting HIV-1, injectable cabotegravir (including oral cabotegravir lead-in), or injectable rilpivirine","Note: Other protocol defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are GS-3242 Tablet, GS-3242 Injection, or Lenacapavir Tablet. The registry lists allocation as randomized. The study will have two portions: Phase 2 and Phase 3.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 700 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.395Z"},{"nctId":"NCT07708961","title":"Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma","officialTitle":"Randomized Phase II Trial to Evaluate the Efficacy of WSD0922-FU When Combined With Adjuvant Temozolomide in Patients With EGFR Mutant Glioblastoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. WSD0922-FU is a targeted treatment which blocks EGFR. It is able to get into the brain and spinal cord and help treat those types of tumors. Adding WSD0922-FU to the usual treatment with temozolomide may be more effective in slowing disease progression, compared to temozolomide alone, in patients with EGFR-mutant, IDH-wildtype glioblastoma.","conditions":["Glioblastoma, IDH-Wildtype"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Archive Sample Retrieval"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Chest Radiography"},{"type":"PROCEDURE","name":"Echocardiography Test"},{"type":"DRUG","name":"EGFR/EGFRvIII Inhibitor WSD0922-FU"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Temozolomide"}],"enrollment":60,"startDate":"2026-08-28","completionDate":"2036-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>= 18 years\n* Histopathologic diagnosis of glioblastoma, IDH-wildtype \\[as defined by the 2021 World Health Organization (WHO) classification of central nervous system (CNS) tumors\\] on primary pathology review\n\n  * NOTE: MGMT promoter methylation status must have been performed\n* Glioblastomas must have a pathogenic EGFR mutation, with or without EGFR amplification, detected by Clinical Laboratory Improvement Act (CLIA)-certified next-generation sequencing\n\n  * EGFR mutation includes both deoxyribonucleic acid (DNA) sequence variants (e.g. point mutations, etc.) and transcript variants (e.g. EGFRvIII, etc.)\n  * EXCEPTIONS: Glioblastomas which are EGFR wildtype with amplification are excluded. Glioblastomas which only have EGFR variants of unknown significance (without any pathogenic EGFR mutations) are also excluded\n* Patients must have completed standard radiation (60 Gy in 30 fractions) with concurrent temozolomide (missing no more than 2 weeks of temozolomide), and adequately recovered from treatment related toxicities\n\n  * NOTE: Adjuvant temozolomide must not have been initiated\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2\n* Hemoglobin \\> 9.0 g/dL (obtained =\\< 14 days prior to registration)\n* Leukocytes \\> 3.0 x 10\\^9/L (obtained =\\< 14 days prior to registration)\n* Absolute neutrophil count (ANC) \\> 1.5 x 10\\^9/L (obtained =\\< 14 days prior to registration)\n* Platelet count \\> 100 x 10\\^9/L (obtained =\\< 14 days prior to registration)\n* Total bilirubin =\\< 1.5 x upper limit of normal (ULN) (\\< 3 x ULN for patients with Gilbert's disease) (obtained =\\< 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) =\\< 3 x ULN (obtained =\\< 14 days prior to registration)\n* Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) =\\< 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained =\\< 14 days prior to registration)\n* Calculated creatinine clearance \\>= 45 mL/min using the Cockcroft-Gault formula (obtained =\\< 14 days prior to registration)\n* Negative pregnancy test done =\\< 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Must be willing to take light-protective measures during the study and for two weeks after last dose of WSD0922-FU\n* Willingness to provide mandatory tissue specimens for correlative research\n\nExclusion Criteria:\n\n* Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field\n\n  * EXCEPTION: Patients deemed to have pseudoprogression are eligible; however, this should be controlled on =\\< 4 mg of dexamethasone and should not require bevacizumab at study onset\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception\n* Any of the following prior therapies:\n\n  * Surgery for glioblastoma =\\< 3 weeks prior to registration\n  * Radiation therapy =\\< 2 weeks prior to registration\n  * Systemic therapies intended for the management of the glioblastoma, including but not limited to:\n\n    * Targeted therapies\n    * EGFR inhibitors\n    * Alkylating chemotherapy\n    * Adjuvant temozolomide (note that temozolomide administered concurrent with radiation is NOT an exclusion criterion)\n    * Immunotherapy\n    * Biologics\n    * Any other systemic therapies \\[Food and Drug Administration (FDA) approved, off-label, investigational\\]\n    * Bevacizumab\n  * Non-enzyme-inducing anticonvulsants \\< 2 weeks prior to registration\n  * Strong inducers and strong inhibitors of CYP3A \\< 14 days prior to registration\n* Failure to adequately recover from any adverse events or complications related to any of the following therapies received prior to registration:\n\n  * Craniotomy and resection of tumor\n  * Stereotactic biopsy of tumor\n  * Other major surgical procedure\n  * Radiation therapy \\< 2 weeks prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Examples include (but are not limited to) refractory nausea and vomiting (if not controlled by supportive therapy), inability to swallow the formulated product, previous significant bowel resection, other chronic gastrointestinal diseases, etc\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Severe skin lesions such as skin/pressure ulcers, chronic leg ulcers or non-healing wounds.\n  * Active history of keratitis\n  * Symptomatic CNS complications that require urgent neurosurgical or medical (e.g. mannitol) intervention\n  * Known intracranial hemorrhage which is unrelated to tumor\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Or psychiatric illness/social situations that would limit compliance with study requirements\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm\n* Other active malignancy within the last 3 years that would interfere with treatment on this protocol\n\n  * EXCEPTIONS: non-melanoma skin cancer, carcinoma in situ of the cervix, patients on hormonal therapy for treated breast or prostate cancer\n* History of myocardial infarction =\\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias","locations":[{"facility":"Mayo Clinic in Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"},{"name":"Cancer Center Clinical Trials","phone":"507-293-6386","email":""}],"primaryOutcomes":["Progression-free survival (PFS)"],"hasResults":false,"conditionSlugs":["glioblastoma","hiv"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","jacksonville-florida","rochester-minnesota"],"enrichment":{"headline":"Phase 2: testing EGFR/EGFRvIII Inhibitor WSD0922-FU for Glioblastoma, IDH-Wildtype","inPlainEnglish":"This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma. Temozolomide is in a class of medications called alkylating agents.","whoItsFor":["Ages 18 Years to any","Histopathologic diagnosis of glioblastoma, IDH-wildtype \\[as defined by the 2021 World Health Organization (WHO) classification of central nervous system (CNS) tumors\\] on primary pathology review","NOTE: MGMT promoter methylation status must have been performed","Glioblastomas must have a pathogenic EGFR mutation, with or without EGFR amplification, detected by Clinical Laboratory Improvement Act (CLIA)-certified next-generation sequencing","EGFR mutation includes both deoxyribonucleic acid (DNA) sequence variants (e.g. point mutations, etc.) and transcript variants (e.g. EGFRvIII, etc.)","EXCEPTIONS: Glioblastomas which are EGFR wildtype with amplification are excluded. Glioblastomas which only have EGFR variants of unknown significance (without any pathogenic EGFR mutations) are also excluded","Patients must have completed standard radiation (60 Gy in 30 fractions) with concurrent temozolomide (missing no more than 2 weeks of temozolomide), and adequately recovered from treatment related toxicities","NOTE: Adjuvant temozolomide must not have been initiated"],"whoShouldSkip":["Patients deemed to have progressive disease based on clinical deterioration after chemoradiation or radiographic progression outside of the radiation field","EXCEPTION: Patients deemed to have pseudoprogression are eligible; however, this should be controlled on =\\< 4 mg of dexamethasone and should not require bevacizumab at study onset","Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown:","Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception","Any of the following prior therapies:","Surgery for glioblastoma =\\< 3 weeks prior to registration","Radiation therapy =\\< 2 weeks prior to registration"],"whatHappens":"If you join, the listed intervention(s) are Archive Sample Retrieval, Biospecimen Collection, or Chest Radiography. The registry lists allocation as randomized. This phase II trial compares the effect of adding WSD0922-FU to temozolomide versus temozolomide alone in slowing disease progression in patients with Epidermal Growth Factor Receptor (EGFR)-mutant, IDH-wildtype glioblastoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.489Z"},{"nctId":"NCT07709000","title":"A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)","officialTitle":"A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK-1045 in Participants With Hematologic Malignancies","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes.\n\nThe goals of this trial are to learn about:\n\n* The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems.\n* The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.","conditions":["Chronic Lymphocytic Leukaemia","Small Lymphocytic Lymphoma","Hematologic Malignancies"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"MK-1045"},{"type":"DRUG","name":"Acetaminophen (or similar antipyretic)"},{"type":"DRUG","name":"Diphenhydramine (or similar antihistamine)"},{"type":"DRUG","name":"Dexamethasone"},{"type":"BIOLOGICAL","name":"Tocilizumab"},{"type":"BIOLOGICAL","name":"Tocilizumab biosimilar"},{"type":"BIOLOGICAL","name":"Siltuximab"}],"enrollment":60,"startDate":"2026-10-14","completionDate":"2033-11-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy.\n* Has confirmed CD19-positive disease.\n* If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy.\n* If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load.\n* If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load.\n\nExclusion Criteria:\n\n* Has a history of serious cardiovascular and cerebrovascular diseases.\n* Has a history or presence of central nervous system disease.\n* Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.\n* Has a diagnosis of immunodeficiency.\n* Has a known additional malignancy that is progressing or required active treatment within the past 2 years.\n* Has active autoimmune disease (not related to underlying leukemia diagnosis) that required systemic treatment in the past 2 years.\n* Has any active acute graft versus host disease (GvHD) or active chronic GvHD requiring systemic treatment.\n* Has active infection requiring systemic therapy.\n* Has not adequately recovered from major surgery or has ongoing surgical complications.\n* Has a diagnosis of Richter Transformation.","locations":[{"facility":"Hospital Pablo Tobon Uribe ( Site 0601)","city":"Medellín","state":"Antioquia","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Los Cobos Medical Center ( Site 0607)","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 0803)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center ( Site 0801)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Haddasah Medical Center ( Site 0800)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sheba Medical Center ( Site 0802)","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center ( Site 0804)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Salamanca ( Site 1102)","city":"Salamanca","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT)","Cohort A Part 1: Number of Participants Who Experience an AE","Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE","Cohort A Parts 1 and 2: Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma","als"],"drugSlugs":[],"locationSlugs":["medell-n-colombia","bogot-colombia","haifa-israel","jerusalem-israel","ramat-gan-israel","tel-aviv-israel","salamanca-spain"],"enrichment":{"headline":"Phase 2: testing MK-1045 for Chronic Lymphocytic Leukaemia","inPlainEnglish":"Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).","whoItsFor":["Ages 18 Years to any","Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy","Has confirmed CD19-positive disease","If human immunodeficiency virus (HIV)-positive, has well-controlled HIV on antiretroviral therapy","If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load","If has a history of hepatitis C virus (HCV) infection, has undetectable HCV viral load"],"whoShouldSkip":["Has a history of serious cardiovascular and cerebrovascular diseases","Has a history or presence of central nervous system disease","Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease","Has a diagnosis of immunodeficiency","Has a known additional malignancy that is progressing or required active treatment within the past 2 years","Has active autoimmune disease (not related to underlying leukemia diagnosis) that required systemic treatment in the past 2 years","Has any active acute graft versus host disease (GvHD) or active chronic GvHD requiring systemic treatment"],"whatHappens":"If you join, the listed intervention(s) are MK-1045, Acetaminophen (or similar antipyretic), or Diphenhydramine (or similar antihistamine). The registry lists allocation as randomized. Researchers are looking for new ways to treat people with B-cell cancers.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 8 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.809Z"},{"nctId":"NCT07710014","title":"Evaluation of Foquest in Adults 65 Years and Older With ADHD","officialTitle":"Evaluation of Foquest® (Multilayer-Release Methylphenidate) in Adults ≥ 65 Years With ADHD: An Open-Label, Investigator-Initiated Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Dar Clinical Research Inc.","sponsorClass":"NETWORK","summary":"This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older.\n\nADHD can persist into older age and is associated with reduced quality of life and difficulties with executive function. Foquest is currently approved in Canada for the treatment of ADHD in adults up to age 65, but there is very limited research on its use in older adults. People over 65 may respond differently to stimulant medications due to age-related changes in how the body processes drugs, other medical conditions, and increased sensitivity to cardiovascular side effects.\n\nThis is an open-label study, meaning all participants will know they are receiving the study medication. There is no placebo group. Participants will take Foquest once daily for approximately 10 weeks, including a 6-week dose adjustment period, a 2-week maintenance period, and a 2-week follow-up period. The dose will start at 25 mg daily and may be increased weekly up to a maximum of 100 mg daily based on how well the participant responds and tolerates the medication.\n\nThe main goal of the study is to measure changes in ADHD symptoms using a clinician-rated scale called the Adult ADHD Investigator Symptom Rating Scale (AISRS). The study will also assess changes in executive function, overall clinical improvement, and cardiovascular safety measures including blood pressure, heart rate, and electrocardiograms (ECGs). Safety will be closely monitored throughout the study, with enhanced cardiovascular monitoring during the first 6 weeks of treatment.","conditions":["Attention Deficit Hyperactivity Disorder"],"keywords":["ADHD","Methylphenidate","Foquest","Geriatric","Extended-Release Stimulant","Attention Deficit Disorder"],"interventions":[{"type":"DRUG","name":"Methylphenidate hydrochloride extended-release capsules"}],"enrollment":36,"startDate":"2026-10-06","completionDate":"2027-07-21","sex":"ALL","minAge":"65 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female aged 65 years or older at the time of consent.\n2. Mentally and physically competent to provide informed consent and willing to comply with the study protocol\n3. Meets DSM-5 criteria for ADHD combined presentation, inattentive presentation, or hyperactive/impulsive presentation based on clinical history\n4. SRS-5 score of 14 or greater at screening\n5. AISRS total score of 24 or greater at baseline\n6. Montreal Cognitive Assessment (MoCA) score of 26 or greater\n\nExclusion Criteria:\n\n1. Satisfied with current ADHD treatment\n2. History of myocardial infarction, arrhythmia, or congenital heart disease\n3. Mean systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg measured in triplicate at screening despite treatment\n4. Treated hypertension not stable on medication or with dose changes in the last 30 days\n5. History of transient ischemic attack or stroke\n6. Current or lifetime DSM-5 diagnosis of bipolar I or II disorder, cyclothymic disorder, or bipolar disorder not otherwise specified\n7. Clinical history strongly suggestive of undiagnosed bipolar spectrum disorder\n8. Active suicidal ideation or behavior per C-SSRS at screening\n9. Current substance use disorder\n10. History of drug or alcohol abuse in the last 10 years as defined by DSM-5 criteria for substance use disorder (moderate or severe)\n11. True allergy to methylphenidate, history of serious adverse reactions to methylphenidate, or known non-response to methylphenidate\n12. History of seizure disorder other than a single childhood febrile seizure before age 3\n13. History of glaucoma, hyperthyroidism, thyrotoxicosis, advanced arteriosclerosis, or severe renal insufficiency (eGFR less than 30 mL/min/1.73 m²)\n14. Use of a monoamine oxidase inhibitor currently or within the past 14 days\n15. Abnormal baseline ECG including left ventricular hypertrophy or QTc greater than 450 ms (males) or greater than 470 ms (females)\n16. History of heart failure, unexplained dyspnea on exertion, or newly identified murmur\n17. MoCA score less than 26 or evidence of cognitive impairment\n18. Currently considered a suicide risk in the opinion of the investigator","locations":[{"facility":"DAR Clinical Research Inc.","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Judy van Stralen, M.D, FRCPC","phone":"613-726-7355","email":"judy@cfpe.ca"},{"name":"Doron Almagor, MD, FRCPC","phone":"613-726-7355 ext. 101","email":"doron.almagor@possibilitiesclinic.com"}],"primaryOutcomes":["Mean Change in Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["ottawa-canada"],"enrichment":{"headline":"Phase 4: testing Methylphenidate hydrochloride extended-release capsules for Attention Deficit Hyperactivity Disorder","inPlainEnglish":"This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older. ADHD can persist into older age and is associated with reduced quality of life and difficulties with executive function.","whoItsFor":["Ages 65 Years to any","Male or female aged 65 years or older at the time of consent","Meets DSM-5 criteria for ADHD combined presentation, inattentive presentation, or hyperactive/impulsive presentation based on clinical history","SRS-5 score of 14 or greater at screening","AISRS total score of 24 or greater at baseline","Montreal Cognitive Assessment (MoCA) score of 26 or greater"],"whoShouldSkip":["Satisfied with current ADHD treatment","History of myocardial infarction, arrhythmia, or congenital heart disease","Mean systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg measured in triplicate at screening despite treatment","Treated hypertension not stable on medication or with dose changes in the last 30 days","History of transient ischemic attack or stroke","Current or lifetime DSM-5 diagnosis of bipolar I or II disorder, cyclothymic disorder, or bipolar disorder not otherwise specified","Clinical history strongly suggestive of undiagnosed bipolar spectrum disorder"],"whatHappens":"If you join, the listed intervention(s) are Methylphenidate hydrochloride extended-release capsules. The registry lists allocation as na. This study is evaluating the safety and effectiveness of Foquest (multilayer-release methylphenidate), a once-daily extended-release medication for attention-deficit/hyperactivity disorder (ADHD), in adults aged 65 years and older.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 36 people at Ottawa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.655Z"},{"nctId":"NCT07710105","title":"Ocrevus Zunovo for MS: Mixed Methods","officialTitle":"Ocrevus Zunovo for Patients With Multiple Sclerosis: Mixed Methods on Barriers and Facilitators to Use and Retention","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"Ocrevus Zunovo implementation, feasibility, acceptability, patient satisfaction, treatment persistence, and impact on MS disease outcomes will be analyzed in this mixed methods study. This study will incorporate clinical data and questionnaire results from MS patients who take Ocrevus Zunovo as well as qualitative interviews with MS patients, family members, and other individuals involved in Ocrevus Zunovo treatment. The purpose of this study is to synthesize implementation strategies that improve patient access to high-efficacy MS therapies in real-world settings.","conditions":["Multiple Sclerosis"],"keywords":["Ocrevus Zunovo","Ocrelizumab","Multiple Sclerosis","Disease-modifying therapy","Subcutaneous injection"],"interventions":[{"type":"OTHER","name":"Clinical Questionnaires"},{"type":"OTHER","name":"Semi-Structured Interviews"},{"type":"DRUG","name":"Ocrevus Zunovo"}],"enrollment":150,"startDate":"2026-06-12","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age of 18 years or older\n* Resident of the USA\n* Seen at Northwestern Medicine\n* Meets diagnostic criteria (2024) for MS, either RMS or PPMS\n* Diagnosis of MS (G35) on file by a neurologist\n* Wants to start or restart a DMT for MS\n* Willing to be in a 12-month follow up study\n\nExclusion Criteria:\n\n* Unclear diagnosis of MS\n* Incarcerated\n* Unable to provide informed consent\n* Current participant in an MS or any experimental therapy clinical trial\n* Moribund\n* Unable to speak a language for which consent processes are available at Northwestern Hospitals\n* Currently taking a DMT that has not been washed out (e.g. recent treatment with Cladribine, Natalizumab, sphingosine 1-phosphate inhibitor, implying the last DMT is still actively immunosuppressing the patient)\n* Current chemotherapy\n* History of stem cell transplant, CAR-T or other chemo-ablative procedures\n* Unwilling to complete surveys over the course of the following 12 months\n* No access to computer or telephone\n* Prior allergic reaction or intolerance to Ocrelizumab IV or SubQ or any monoclonal antibody therapy\n* Hypogammaglobulinemia IgG level \\<500\n* Leukopenia \\<2.0\n* Active hepatitis or latent hepatitis B\n* Elevated liver enzymes 3 times the upper limit of normal\n* Tuberculosis\n* Current serious infection, e.g. COVID-19, shingles, active pneumonia, progressive multifocal leukoencephalopathy, etc.\n* Currently pregnant, breastfeeding, or a person of childbearing capacity who is sexually active without a documented plan of current contraceptive methods.\n* Any other diagnosis or reason deemed to make the participant unfit for participation by the study PI","locations":[{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dylan Rice, B.A.","phone":"312-503-5298","email":"dylan.rice@northwestern.edu"},{"name":"Audrey Chang, B.A.","phone":"312-503-8639","email":"audrey.chang@northwestern.edu"}],"primaryOutcomes":["Patient Satisfaction and Treatment Persistence"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":["ocrelizumab"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: testing Ocrevus Zunovo for Multiple Sclerosis","inPlainEnglish":"Ocrevus Zunovo implementation, feasibility, acceptability, patient satisfaction, treatment persistence, and impact on MS disease outcomes will be analyzed in this mixed methods study. This study will incorporate clinical data and questionnaire results from MS patients who take Ocrevus Zunovo as well as qualitative interviews with MS patients, family members, and other individuals involved in Ocrevus Zunovo treatment.","whoItsFor":["Ages 18 Years to any","Age of 18 years or older","Resident of the USA","Seen at Northwestern Medicine","Meets diagnostic criteria (2024) for MS, either RMS or PPMS","Diagnosis of MS (G35) on file by a neurologist","Wants to start or restart a DMT for MS","Willing to be in a 12-month follow up study"],"whoShouldSkip":["Unclear diagnosis of MS","Current participant in an MS or any experimental therapy clinical trial","Unable to speak a language for which consent processes are available at Northwestern Hospitals","Currently taking a DMT that has not been washed out (e.g. recent treatment with Cladribine, Natalizumab, sphingosine 1-phosphate inhibitor, implying the last DMT is still actively immunosuppressing the patient)","Current chemotherapy","History of stem cell transplant, CAR-T or other chemo-ablative procedures","Unwilling to complete surveys over the course of the following 12 months"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.992Z"},{"nctId":"NCT07712939","title":"A Phase 1, First-in-Human Study of CND319 in Healthy Participants and Patients With Rheumatic Diseases","officialTitle":"A Phase 1, First-In-Human, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CND319 in Healthy Participants and Patients With Rheumatic Diseases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Candid Therapeutics","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.","conditions":["Healthy Participants Study","Rheumatoid Arthritis","Sjogren's Syndrome"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"CND319"}],"enrollment":105,"startDate":"2026-07-22","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria (SAD):\n\n1. 18 to 65 years old\n2. Body mass index 18-30 kg/m2 and weight 55-100 kg\n3. Individuals in good health\n4. Agree to abstain from consumption of alcohol 48 hours prior to study visits\n5. Agree to the use of highly effective contraception as defined in the protocol\n\nInclusion Criteria (MAD and Part 2 Expansion):\n\nPatients with RA:\n\n1. 18 to 75 years old\n2. Diagnosis of adult-onset RA\n3. Class I-III RA\n4. Moderately to severely active RA\n\nPatients with SjD:\n\n1. 18 to 75 years old\n2. Diagnosis of primary SjD\n\nExclusion Criteria (SAD):\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons\n5. History of alcohol or drug abuse within last 12 months\n6. Positive alcohol breathalyzer or drug screen prior to dosing\n7. Inability to comply with protocol-mandated requirements\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug\n9. Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study\n10. Blood donation or significant blood loss within 30 days\n11. Individuals considered to be part of a vulnerable population (eg, incarceration)\n12. Individuals that in the opinion of the Investigator, are not suitable for participation in the trial\n\nExclusion Criteria for patients with RA or SjD:\n\n1. Inadequate clinical laboratory parameters at Screening\n2. Active infection\n3. Receipt of or inability to discontinue any excluded therapies\n4. History of progressive multifocal leukoencephalopathy\n5. Central nervous system disease\n6. Presence of 1 or more significant concurrent medical conditions\n7. Have a diagnosis or history of malignant disease within 5 years\n8. History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of study drug\n9. Women who are pregnant or breastfeeding\n10. Patients who do not agree to the use of highly effective contraception as defined by the protocol","locations":[{"facility":"Candid Clinical Site","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Operations","phone":"8582470550","email":"ClinicalTrials@candidrx.com"}],"primaryOutcomes":["Incidence proportion and severity of treatment-emergent adverse events through end of study","Changes to body temperature","Changes to heart rate","Changes to respiratory rate","Changes to blood pressure","Changes to pulse oximetry","Changes from baseline in ECG parameters through end of study: PR interval","Changes from baseline in ECG parameters through end of study: QRS interval","Changes from baseline in ECG parameters through end of study: QT interval","Changes from baseline in safety laboratory assessments through end of study"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["melbourne-australia"],"enrichment":{"headline":"Phase 1: testing CND319 for Healthy Participants Study","inPlainEnglish":"This study wants to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.","whoItsFor":["Ages 18 Years to 65 Years","Body mass index 18-30 kg/m2 and weight 55-100 kg","Individuals in good health","Agree to abstain from consumption of alcohol 48 hours prior to study visits","Agree to the use of highly effective contraception as defined in the protocol","who can join (MAD and Part 2 Expansion):","Diagnosis of adult-onset RA","Moderately to severely active RA"],"whoShouldSkip":["Inadequate clinical laboratory parameters at Screening","Receipt of or inability to discontinue any excluded therapies","Individuals with immediate household contact with your children (eg, ≤ 6 years old) or immunocompromised persons","History of alcohol or drug abuse within last 12 months","Positive alcohol breathalyzer or drug screen prior to dosing","Inability to comply with protocol-mandated requirements","History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant anti-body-related fusion proteins) or any constituents of study drug"],"whatHappens":"If you join, the listed intervention(s) are CND319. The registry lists allocation as na. This study wants to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary clinical activity of CND319 in healthy adult participants and patients with rheumatic diseases.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 105 people at Melbourne. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.966Z"},{"nctId":"NCT07713797","title":"Biomarkers for Endometriosis","officialTitle":"A Prospective, Observational and Multicentric Study to Evaluate the Performance and Clinical Utility of EndoID ELISA Kit to Determine Circulating Synuclein Gamma (SNCG) and B-cell Lymphoma-6 (BCL6) Levels as Potential Biomarkers for Endometriosis\"","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Trio Fertility","sponsorClass":"OTHER","summary":"Endometriosis is a condition in which tissue similar to the lining of the uterus grows outside the uterus, often causing pain and infertility. Currently, endometriosis can only be definitively diagnosed through invasive procedures like laparoscopy and biopsy.\n\nThe purpose of this study is to investigate whether the proteins Synuclein Gamma (SNCG) and B-Cell Lymphoma 6 (BCL6), measurable in blood and menstrual fluid, can serve as non-invasive biomarkers to diagnose or monitor endometriosis.","conditions":["Endometriosis"],"keywords":["endometriosis","biomarkers","BCL6","SNCG"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"SNCG Protein"},{"type":"DIAGNOSTIC_TEST","name":"BCL-6 Protein"}],"enrollment":100,"startDate":"2026-01-16","completionDate":"2027-01-01","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria for Endometriosis Group:\n\n* Women of reproductive age group (18Y-45Y).\n* Women with active endometriosis diagnosed by ultrasound/MRI/laparoscopy.\n\nExclusion Criteria for Endometriosis Group:\n\n* Women \\<18Y and \\>45Y.\n* Women with endometriosis during stimulation with gonadotropins.\n* Current or prior history of uterine, ovarian, colon, pancreatic, breast or any other type of cancer.\n* Any prior history of chronic illness.\n* Pregnant women.\n\nInclusion Criteria for Control Group:\n\n* Women of reproductive age group (18Y-45Y).\n* Women without endometriosis and any other gynaecological problem.\n\nExclusion Criteria for Endometriosis Group:\n\n* Women \\<18Y and \\>45Y\n* Prior history of any disease including cancer or chronic illness.\n* Pregnant women.","locations":[{"facility":"Trio Fertility","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yasaman Sadeghi, M.Sc.","phone":"4165060804","email":"yasamans@triofertility.com"}],"primaryOutcomes":["Synuclein Gamma (SNCG) and B-cell Lymphoma 6 (BCL-6) Levels"],"hasResults":false,"conditionSlugs":["lymphoma","endometriosis"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: SNCG Protein for Endometriosis","inPlainEnglish":"Endometriosis is a condition in which tissue similar to the lining of the uterus grows outside the uterus, often causing pain and infertility. Currently, endometriosis can only be definitively diagnosed through invasive procedures like laparoscopy and biopsy.","whoItsFor":["Ages 18 Years to 45 Years","Women only","for Endometriosis Group:","Women of reproductive age group (18Y-45Y)","Women with active endometriosis diagnosed by ultrasound/MRI/laparoscopy"],"whoShouldSkip":["for Endometriosis Group:","Women \\<18Y and \\>45Y","Women with endometriosis during stimulation with gonadotropins","Current or prior history of uterine, ovarian, colon, pancreatic, breast or any other type of cancer","Any prior history of chronic illness","who can join for Control Group:","Women of reproductive age group (18Y-45Y)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Toronto. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.118Z"},{"nctId":"NCT07713940","title":"Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous","officialTitle":"Effect of Anti-inflammatory Diet in Systemic Lupus Erythematous","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus","conditions":["Systemic Lupus Erthematosus (SLE)"],"keywords":["lupus","diet","anti-inflammatory diet","mediterranean diet","cellcept","mycophenalate","microbiome"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"anti-inflammatory diet"}],"enrollment":36,"startDate":"2026-07-01","completionDate":"2028-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients who meet the 2019 EULAR/ACR Classification Criteria for SLE\n* patients who are on Cellcept or Myfortic for at least 3 months prior to screening\n* patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale.\n\nExclusion Criteria:\n\n* pregnant or lactating patients,\n* patients with food allergy\n* patients on antibiotics within 4 weeks of the screening\n* patients that change the SLE therapy during the length of the study (12 weeks).","locations":[{"facility":"Altman Clinical Translational Research Insitute (UC San Diego)","city":"La Jolla","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Monica Guma, MD, PhD","phone":"858-822-6523","email":"mguma@health.ucsd.edu"}],"primaryOutcomes":["PROMIS pain interference","PROMIS fatigue"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["la-jolla-california"],"enrichment":{"headline":"Not a traditional drug phase: anti-inflammatory diet for Systemic Lupus Erthematosus (SLE)","inPlainEnglish":"To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus","whoItsFor":["Ages 18 Years to any","patients who meet the 2019 EULAR/ACR Classification Criteria for SLE","patients who are on Cellcept or Myfortic for at least 3 months prior to screening","patients with a score of ≥55 on the Patient Reported Outcomes Measurement Information System (PROMIS) Pain interference scale"],"whoShouldSkip":["pregnant or lactating patients,","patients with food allergy","patients on antibiotics within 4 weeks of the screening","patients that change the SLE therapy during the length of the study (12 weeks)"],"whatHappens":"If you join, the listed intervention(s) are anti-inflammatory diet. The registry lists allocation as na. To study the effect of anti-inflammatory diet on clinical and biological outcomes in lupus","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at La Jolla. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:35.071Z"},{"nctId":"NCT07716098","title":"A Study of Esketamine Nasal Spray Versus Placebo Spray in Adult Participants With Treatment-resistant Depression","officialTitle":"A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate how well each individual dose of esketamine (56 milligrams \\[mg\\] and 84 mg) works when compared with placebo in improving depressive symptoms in participants with treatment resistant depression (individuals with major depressive disorder \\[MDD\\] who have not responded to at least 2 different antidepressant treatments given at an adequate dose for an adequate duration in the current episode of depression).","conditions":["Depressive Disorder, Treatment-Resistant"],"keywords":[],"interventions":[{"type":"DRUG","name":"Esketamine 56 mg"},{"type":"DRUG","name":"Esketamine 84 mg"},{"type":"DRUG","name":"Placebo"}],"enrollment":348,"startDate":"2026-07-23","completionDate":"2028-12-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must meet the diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single episode MDD, the duration of the episode must be greater than or equal to \\[\\>=\\] 12 months) or recurrent MDD, without psychotic features, based upon clinical assessment and confirmed by the mini international neuropsychiatric interview (MINI) as the primary diagnosis. Participant must have had the first onset of depression prior to 55 years of age\n* Participant must have had nonresponse (less than or equal to \\[\\<=\\] 25 percent \\[%\\] improvement) to \\>=2 oral antidepressant treatments in the current episode of depression, assessed using the massachusetts general hospital-antidepressant treatment response questionnaire (MGH-ATRQ), and confirmed by documented records (for example, medical/pharmacy/prescription records or a letter from a treating physician)\n* The participant's current major depressive episode, depression symptom severity, and antidepressant treatment response in the current depressive episode, must be confirmed by the state versus trait, assessability, face validity, ecological validity, rule of three P's (SAFER) Interview\n* Participant must be comfortable with self-administration of nasal spray medication and be able to follow the nasal spray administration instructions provided\n* A female participant of childbearing potential must have a negative highly sensitive serum (β-human chorionic gonadotropin \\[β-hCG\\]) at the start of screening and a negative urine pregnancy test must be obtained before the first dose of study drug on Day 1, prior to randomization\n\nExclusion Criteria:\n\n* The participant has used ketamine/esketamine (lifetime)\n* The participant's depressive symptoms have demonstrated nonresponse in the current major depressive episode to an adequate course of treatment with electroconvulsive therapy (ECT), defined as at least 7 treatments with unilateral/bilateral ECT, or to adequate course of treatment with transcranial magnetic stimulation (TMS), defined as at least 4 weeks of treatment with 5 sessions per week\n* Participant has received vagal nerve stimulation (VNS) or deep brain stimulation (DBS) in the current episode of depression\n* Participant has homicidal ideation/intent, per the investigator's clinical judgment, or has suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator's clinical judgment or based on the columbia suicide severity rating scale (C-SSRS), corresponding to a response of \"Yes\" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation on the C-SSRS, or a history of suicidal behavior within the past year prior to the start of the screening phase. Participants reporting suicidal ideation with intent to act or suicidal behavior prior to the start of the double-blind treatment phase should be excluded\n* Participant has a history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria, except nicotine or caffeine, within 6 months before the start of the screening phase. a. A history (lifetime) of ketamine, phencyclidine (PCP), lysergic acid diethylamide (LSD), or 3, 4-methylenedioxy-methamphetamine (MDMA) hallucinogen-related use disorder is exclusionary\n* Participant has a current or history of seizures (uncomplicated childhood febrile seizures with no sequelae are not exclusionary)","locations":[{"facility":"Anderson Clinical Research","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Artemis Institute for Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Connecticut Health Center","city":"Farmington","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Family Research Group","city":"Cape Coral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pharmax Research Clinic Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psych Atlanta, P.C.","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accelerated Clinical Research Group LLC","city":"Snellville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Research Group","city":"Saint Maries","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Psychiatric Medicine Associates LLC","city":"Skokie","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Watertown","city":"Watertown","state":"Massachusetts","country":"United 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6"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["dothan-alabama","little-rock-arkansas","anaheim-california","irvine-california","long-beach-california","orange-california","walnut-creek-california","coral-gables-florida","gainesville-florida","jacksonville-florida","maitland-florida","orlando-florida","atlanta-georgia","union-city-georgia","bardstown-kentucky","owensboro-kentucky","springfield-massachusetts","worcester-massachusetts","jackson-mississippi","las-vegas-nevada","staten-island-new-york","portland-oregon","north-charleston-south-carolina","memphis-tennessee","austin-texas","friendswood-texas","san-antonio-texas","provo-utah","fairfax-virginia","petersburg-virginia","everett-washington"],"enrichment":{"headline":"Phase 3: testing Solriamfetol Dose A for ADHD","inPlainEnglish":"This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 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The registry lists allocation as randomized. This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in children aged 6 to \\<12 years with ADHD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 468 people at 31 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.641Z"},{"nctId":"NCT07717892","title":"Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-3)","officialTitle":"A Phase 3, Randomized, 6-Week, Double-blind, Placebo- Controlled Trial of Solriamfetol in Adolescents Aged 12 to <18 Years With Attention Deficit Hyperactivity Disorder (ADHD)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Axsome Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This study is a Phase 3, multi-center, randomized, 6-week, double-blind, placebo-controlled, parallel-group trial to assess the efficacy and safety of solriamfetol in adolescents aged 12 to \\<18 years with ADHD.","conditions":["ADHD"],"keywords":["Attention deficit hyperactivity disorder","ADHD","Sunosi","Solriamfetol","Axsome","Non-stimulant therapy","Dopamine norepinephrine reuptake inhibitor"],"interventions":[{"type":"DRUG","name":"Solriamfetol Dose A"},{"type":"DRUG","name":"Solriamfetol Dose B"},{"type":"DRUG","name":"Placebo"}],"enrollment":468,"startDate":"2026-06-25","completionDate":"2028-06-30","sex":"ALL","minAge":"12 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female, aged 12 to \\<18 years.\n* Primary diagnosis of ADHD according to DSM-5 criteria.\n* Has parents/legal guardians provide written informed consent and has child provide written informed assent to participate in the study before the conduct of any study procedures.\n\nExclusion Criteria:\n\n* Unable to comply with study procedures.\n* Medically inappropriate for study participation in the opinion of the investigator.","locations":[{"facility":"Clinical Research Site","city":"Dothan","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Site","city":"Irvine","state":"California","country":"United 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Solriamfetol Dose A for ADHD","inPlainEnglish":"This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in adolescents aged 12 to \\<18 years with ADHD.","whoItsFor":["Ages 12 Years to 17 Years","Male or female, aged 12 to \\<18 years","Primary diagnosis of ADHD according to DSM-5 criteria"],"whoShouldSkip":["Unable to comply with study procedures","Medically inappropriate for study participation in the opinion of the investigator"],"whatHappens":"If you join, the listed intervention(s) are Solriamfetol Dose A, Solriamfetol Dose B, or Placebo. The registry lists allocation as randomized. This study is a Phase 3, multi-center, randomly assigned, 6-week, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial to assess the how well it works and safety of solriamfetol in adolescents aged 12 to \\<18 years with ADHD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 468 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.644Z"},{"nctId":"NCT07718854","title":"Sacituzumab Tirumotecan +/- Pembrolizumab in I/O Exposed Metastatic or Recurrent Ovarian Clear Cell Cancer","officialTitle":"A Phase 2 Non-comparative Screening Trial of Sacituzumab Tirumotecan (MK2870) Alone and in Combination With Pembrolizumab in Ovarian Clear Cell Carcinoma Previously Exposed to Immunotherapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Tufts Medical Center","sponsorClass":"OTHER","summary":"This is a phase II, two-arm, noncomparative screening study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy. The regimens will be evaluated separately, and the study is not designed or powered to compare the regimens.","conditions":["Ovarian Clear Cell Carcinoma","Metastatic Ovarian Cancer","Recurrent Ovarian Clear Cell Adenocarcinoma"],"keywords":["clear cell carcinoma","ovarian","Sacituzumab","MK2870","pembrolizumab"],"interventions":[{"type":"DRUG","name":"Sacituzumab tirumotecan"},{"type":"DRUG","name":"Pembrolizumab"}],"enrollment":50,"startDate":"2026-09-12","completionDate":"2036-09","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nAn individual is eligible for inclusion in the study if the individual meets all of the following criteria:\n\nType of Participant and Disease Characteristics\n\n1. Age ≥18 years (at the time of informed consent).\n2. Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial.\n3. Has measurable disease per RECIST 1.1 as assessed by the local site investigator/ radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions.\n4. Patients must have received at least one prior platinum and taxane-based chemotherapy regimen; maintenance treatment will not be counted as a separate regimen. Radiation therapy (including the use of chemotherapy as a radiosensitizer) will not count as a prior systemic regimen. There is otherwise no line limit for entry in to this trial.\n5. Patients must have also received one prior line containing an immune checkpoint inhibitor (ICI). More than one prior line of ICI treatment will be exclusionary.\n6. Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.\n7. ECOG performance status 0-1\n8. Is an individual of assigned female sex at birth\n9. Participant is not pregnant or breastfeeding, and at least one of the following conditions applies:\n\n   • Is not a Person of Child-Bearing Potential (POCBP) OR\n\n   • Is a POCBP and:\n\n   \\- Agrees to use of a contraceptive method that is highly effective (with a failure rate of \\<1% per year), with low user dependency, or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) beginning at the time of informed consent, during the study treatment, and for at least 210 days after the last dose of study drug. During this period, the participant agrees not to donate eggs (ova, oocytes) to others or freeze/store eggs during this period for the purpose of reproduction.\n\n   \\- The investigator should evaluate the potential for contraceptive method failure (i.e., noncompliance, recently initiated) in relationship to the first dose of study intervention. Contraceptive use by POCBPs should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions are more stringent than the requirements above, the local label requirements are to be followed.\n\n   \\- Has a negative highly sensitive pregnancy test (urine or serum) as required by local regulations within 24 hours (for a urine test) or 72 hours (for a serum test) before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are in Section 8.3.5.\n\n   \\- Abstains from breastfeeding during the study intervention period and for at least 10 days after study intervention.\n\n   \\- Medical history, menstrual history, and recent sexual activity have been reviewed by the investigator to decrease the risk for inclusion of a POCBP with an early undetected pregnancy.\n\n   Informed Consent\n10. The participant provides written informed consent for the study. Additional Categories\n11. Has provided an archival tumor tissue sample (slides or block) for pathologic confirmation of diagnosis at Tufts Medical Center.\n12. Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible.\n13. Adequate organ function as defined in protocol Table 3. Specimens must be collected within 10 days before the start of study intervention.\n14. Any other medical condition that will prevent the safe administration of study drugs in the opinion of the treating physician.\n15. Be willing and able to comply with study procedures, laboratory tests, and other requirements of the study.\n16. HIV-infected participants must have well-controlled HIV on ART, defined as:\n\n    a. Having a CD4+ T-cell count ≥350 cells/mm3 at the time of screening b. Having achieved and maintained virologic suppression, defined as confirmed HIV RNA level below 50 or the LLOQ using the locally available assay, at the time of screening and for at least 12 weeks before screening.\n\n    c. Absence of any AIDS-defining opportunistic infections within the past 12 months d. Being on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before randomization and agreeing to continue ART throughout the study Note: The ART regimen must not contain any antiretroviral medications that are strong CYP3A4 inducers/inhibitors/substrates. Refer to https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers. Please note that this list is not exhaustive and that investigators should review the locally-approved label for all concomitant therapy to ensure it is not a strong inducer/inhibitor/substrate of CYP3A4.\n\n    HIV testing at screening is not otherwise required.\n17. Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load before randomization.\n\n    Note: Participants should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.\n\n    Hepatitis B testing at screening is not required unless:\n    * There is a known history of HBV infection\n    * Mandated by local guidelines\n18. Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening.\n\nNote: Participants must have completed curative antiviral therapy at least 4 weeks before randomization.\n\nHepatitis C testing at screening is not required unless:\n\n* There is a known history of HCV infection\n* Mandated by local guidelines\n\nExclusion Criteria\n\nAn individual must be excluded from the study if the individual meets any of the following criteria:\n\nMedical Conditions 18. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.\n\n19\\. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \\>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months before the first dose of study intervention.\n\n20\\. Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n\n21\\. Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) 22. History of stem cell/solid organ transplant. Prior/Concomitant Therapy 23. Received prior treatment with a TROP2-targeted ADC. 24. Received prior treatment with a topoisomerase 1 inhibitor-containing ADC. 25. Received prior systemic anticancer therapy within 2 weeks before the first dose of study intervention.\n\n26\\. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has radiation pneumonitis.\n\nNote: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.\n\n27\\. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.\n\n28\\. Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks.\n\nPrior/Concurrent Clinical Study Experience 29. Is currently enrolled on another therapeutic clinical trial. Concurrent enrollment on another therapeutic clinical trial or any trial designed to impact the efficacy of anti-cancer therapy is prohibited.\n\n30\\. Has received an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention.\n\nDiagnostic Assessments 31. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.\n\nNote: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ of any organ (excluding carcinoma in situ of the bladder) who have undergone potentially curative resection are not excluded.\n\nNote: Participants with low-risk early-stage prostate cancer (T1-T2a, Gleason score ≤6, and PSA \\<10 ng/mL) either treated with definitive intent or untreated in active surveillance with stable disease are not excluded.\n\n32\\. Has CNS metastases and/or carcinomatous meningitis. 33. Has an active infection requiring systemic therapy. 34. Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the individual's ability to cooperate with the requirements of the study, or interfere with the individual's participation for the full duration of the study, such that it is not in the best interest of the individual to participate, in the opinion of the treating investigator.\n\nOther Exclusions 35. Severe hypersensitivity (Grades ≥3) to study interventions, any of their excipients, and/or to another biologic therapy.\n\n36\\. Has had major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention. Anticipation of the need for major surgery during the course of treatment with study intervention is also exclusionary.\n\nNote: Participants who underwent major surgery must have adequately recovered from toxicity and/or complications from the surgery before starting study intervention.\n\n37\\. Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.\n\n38\\. History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.","locations":[{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Neely Center for Clinical Cancer Research","phone":"617-636-5000","email":"TMNCCCR@tuftsmedicine.org"}],"primaryOutcomes":["Objective response rate for sacituzumab tirumotecan alone and sacituzumab tirumotecan plus pembrolizumab, defined as the proportion of treated participants with a best overall response of complete response or partial response."],"hasResults":false,"conditionSlugs":["ovarian-cancer","endometriosis"],"drugSlugs":["pembrolizumab"],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Phase 2: testing Sacituzumab tirumotecan for Ovarian Clear Cell Carcinoma","inPlainEnglish":"This is a phase II, two-arm, noncomparative screening study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy. The regimens will be evaluated separately, and the study is not designed or powered to compare the regimens.","whoItsFor":["Ages 18 Years to any","Women only","An individual is eligible for inclusion in the study if the individual meets all of the following criteria:","Type of Participant and Disease Characteristics","Has a histologically-confirmed diagnosis of pure OCCC. Patients with mixed histologies that include a clear cell component will not be eligible for this trial","Has measurable disease per RECIST 1.1 as assessed by the local site investigator/ radiology. Lesions situated in a previously-irradiated area are considered measurable if progression has been shown in such lesions","Patients must have also received one prior line containing an immune checkpoint inhibitor (ICI). More than one prior line of ICI treatment will be exclusionary","Participants with known brain metastases are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other side effects","how well you can do daily activities (ECOG score) 0-1"],"whoShouldSkip":["An individual must be excluded from the study if the individual meets any of the following criteria:","Medical Conditions 18. Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing","20\\. Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug","26\\. Received prior radiotherapy within 2 weeks before the first dose of study intervention, has radiation-related toxicities, requiring corticosteroids, and/or has radiation pneumonitis","Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention","27\\. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed","28\\. Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of treatment with study intervention. The required washout period before starting study intervention is 2 weeks"],"whatHappens":"If you join, the listed intervention(s) are Sacituzumab tirumotecan, or Pembrolizumab. The registry lists allocation as randomized. This is a phase II, two-arm, noncomparative screening study of Sacituzumab tirumotecan, an intravenous antibody-drug conjugate (ADC) that targets Trop-1, administered alone or in combination with pembrolizumab, a monoclonal antibody to PD-1 in patients with relapsed clear cell cancers that originated in the ovary, fallopian tube or peritoneal cavity, inclusive of endometriosis (collectively referred to as OCCC throughout the protocol) after previous treatment with anti-PD1 therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Boston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.159Z"},{"nctId":"NCT07719426","title":"Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study","officialTitle":"Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","sponsorClass":"OTHER","summary":"Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1). The incidence of CRC in IBD has gradually declined, attributed to enhanced detection of preneoplastic lesions (dysplasia), improved adherence to screening recommendations, utilization of advanced high-definition endoscopes (2-4), and the implementation of more efficacious therapeutic strategies (5-9).\n\nPresently, there is no consensus on the endoscopic management of dysplastic lesions. Recent techniques such as submucosal dissection (ESD) enable the resection of non-polypoid flat lesions larger than 2 cm. Lesions previously treated with colectomy can now be resected by ESD with en-bloc resection rates of approximately 85.7% (17). However, long-term data on the risk of local or distant recurrence after endoscopic resection in IBD is lacking. It is crucial to evaluate complete (R0) and curative resection rates, as well as the rate of local recurrence, based on the type of endoscopic treatment.\n\nIn light of the 21st century advancements, characterized by high-definition endoscopes and targeted treatments, it is imperative to:\n\n* Assess the prevalence and incidence of dysplasia in IBD and its risk of progression to CRC.\n* Specifically characterize the endoscopy and histology of pre-neoplastic lesions in IBD to facilitate better selection of lesions amenable to endoscopic treatment or surgery.\n* Evaluate the rates of local and distant recurrence over time, considering factors associated with this evolving risk (IBD characteristics, endoscopic appearance, histology, type of resection, etc.).","conditions":["Crohn Disease (CD)","Colitis Ulcerative"],"keywords":["All IBD patients requiring colonoscopy for screening or treatment of dysplasia are eligible for inclusion"],"interventions":[],"enrollment":800,"startDate":"2026-09-17","completionDate":"2033-09-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients age ≥ 18 years\n* Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria.\n* IBD patients requiring screening colonoscopy for dysplasia as following:\n\n  * IBD (CD/UC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)\n  * For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)\n  * For CD: Colonic (L2) or ileocolonic (L3) Crohn's disease with \\> 50% involvement of the colon.\n* Patient affiliated to the health security system\n* Patient who has received information about the study by the investigator and agreed to participate.\n\nExclusion Criteria:\n\n* Patient followed for ileal Crohn's disease (L1)\n* Patient followed for rectal ulcerative colitis (E1)\n* Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center\n* Patients \\< 18 years old\n* Patient under guardianship or curatorship\n* Patient objects to their personal data being used in the context of research","locations":[{"facility":"CHU d'Amiens","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Besançon","city":"Besançon","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"SEGUIN A Project manager","phone":"+ 33 (0) 7 66 42 69 85","email":"aseguin@getaid.org"}],"primaryOutcomes":["To evaluate the prevalence of dysplasia in patients with IBD at high risk of preneoplastic lesions followed prospectively in a screening program at the time of high-definition endoscopes."],"hasResults":false,"conditionSlugs":["colorectal-cancer","crohns-disease"],"drugSlugs":[],"locationSlugs":["amiens-france","besan-on-france"],"enrichment":{"headline":"Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory …","inPlainEnglish":"Inflammatory Bowel Disease (IBD) patients have an increased risk of ColoRectal Cancer (CRC). The cumulative risk of CRC development is estimated at 1% after 10 years of disease progression, 2% after 20 years, and 5% after more than 20 years of disease progression (1).","whoItsFor":["Ages 18 Years to any","Patients age ≥ 18 years","Documented diagnosis of CD or UC established based on standard clinical, endoscopic and histological criteria","IBD patients requiring screening colonoscopy for dysplasia as following:","IBD (CD/UC) evolving for more than 8 years, or for ≥1 year if associated with Primary Sclerosing Cholangitis (PSC)","For UC: Extended ulcerative colitis (E2 or E3 in the Montreal classification)","For CD: Colonic (L2) or ileocolonic (L3) Crohn's disease with \\> 50% involvement of the colon","Patient affiliated to the health security system"],"whoShouldSkip":["Patient followed for ileal Crohn's disease (L1)","Patient followed for rectal ulcerative colitis (E1)","Patient referred for a therapeutic endoscopic procedure, without prior or subsequent follow-up in the participating center","Patients \\< 18 years old","Patient under guardianship or curatorship","Patient objects to their personal data being used in the context of research"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 800 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.888Z"},{"nctId":"NCT07719972","title":"Universal Newborn Screening For Sickle Cell Disease In Mozambique","officialTitle":"Universal Newborn Screening For Sickle Cell Disease In Mozambique","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"St. Jude Children's Research Hospital","sponsorClass":"OTHER","summary":"The overarching goal of this study is to evaluate the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings. The study will be done in Mozambique.","conditions":["Sickle Cell Disease"],"keywords":["Mozambique","Patient participants","Healthy control participants","Health facility staff participants","Supply chain expert participants","National public health system expert participants"],"interventions":[{"type":"OTHER","name":"Point-of-care testing (POCT) -Patient participants"},{"type":"OTHER","name":"Point-of-care testing (POCT) - Healthy control participants"},{"type":"OTHER","name":"Context Assessment for Community Health (COACH) survey"},{"type":"OTHER","name":"Semi-structured interview"}],"enrollment":6750,"startDate":"2026-09-24","completionDate":"2031-08","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Children participants: All infants between birth and 6.0 months of age who are born or receive care at secondary-level facilities involved in the UNIQUE study.\n* Children participants will fall into one of two categories:\n\n  * Patient participants: All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results.\n  * Healthy control participants: Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS).\n* Health facility staff participants: Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study.\n* Supply chain expert participants: Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products.\n* National public health system expert participants: Administrative professionals with experience working in the national public health system (e.g., Ministry of Health, MISAU) who oversee the delivery of health services to infants in-country, such as neonatal testing and vaccination programs.\n\nExclusion Criteria:\n\n* Children participants:\n\n  * Stillbirths.\n  * Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.\n* Patient participants: none\n* Healthy control participants:\n\n  * Stillbirths.\n  * Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results.\n* Health facility staff participants: none.\n* Supply chain expert participants: none.\n* National public health system expert participants: none.","locations":[{"facility":"Hospital Rural de Nhamatanda","city":"Nhamatanda","state":"Sofala","country":"Mozambique","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jane Hankins, MD","phone":"888-226-4343","email":"referralinfo@stjude.org"}],"primaryOutcomes":["Percentage of eligible population screened for Sickle Cell Disease","Percentage of new SCD cases linked to care"],"hasResults":false,"conditionSlugs":["sickle-cell"],"drugSlugs":[],"locationSlugs":["nhamatanda-mozambique"],"enrichment":{"headline":"Not a traditional drug phase: Point-of-care testing (POCT) -Patient participants for Sickle Cell Disease","inPlainEnglish":"The overarching goal of this study is to measure the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings.","whoItsFor":["Children participants: All infants between birth and 6.0 months of age who are born or receive care at secondary-level facilities involved in the UNIQUE study","Children participants will fall into one of two categories:","Patient participants: All infants between birth and 6.0 months of age who were screened through the UNIQUE study and tested positive for SCD (HbSS, HbSC, or other form of SCD) or had indeterminate results","Healthy control participants: Infants between birth and 6.0 months of age who screen negative for SCD (HbAA) through the UNIQUE study or tested positive for sickle cell trait (HbAS)","Health facility staff participants: Healthcare staff ages ≥18 years working at secondary-level facilities involved in the UNIQUE study","Supply chain expert participants: Administrative professionals with experience working in or around the national supply chain systems in Mozambique to support procurement, importation, customs clearance, storage, and in-country distribution of medical products"],"whoShouldSkip":["Children participants:","Children who received an erythrocyte (blood) transfusion within 3 months of testing. Exogenous (transfused) HbA could artificially lower the sickle hemoglobin concentration, thus causing false-negative results","Patient participants: none","Healthy control participants:","Health facility staff participants: none","Supply chain expert participants: none","National public health system expert participants: none"],"whatHappens":"If you join, the listed intervention(s) are Point-of-care testing (POCT) -Patient participants, Point-of-care testing (POCT) - Healthy control participants, or Context Assessment for Community Health (COACH) survey. The registry lists allocation as randomized. The overarching goal of this study is to measure the feasibility of a new methodology that combines three multi-level implementation strategies to optimize the population-level uptake of essential evidence-based, standard of care treatments for infants with sickle cell disease (SCD) in low-resource settings.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 6,750 people at Nhamatanda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.832Z"},{"nctId":"NCT07721467","title":"Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin","officialTitle":"Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin (NECTAR) in Aging and Alzheimer's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Institute on Aging (NIA)","sponsorClass":"NIH","summary":"Background:\n\nNormal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults. They also want to know if psilocybin, a compound found in certain mushrooms, can further support improved brain function.\n\nObjective:\n\nTo learn how regular cognitive training, with or without psilocybin, can improve brain health in older adults.\n\nEligibility:\n\nPeople aged 65 years and older with mild cognitive impairment or early-stage Alzheimer s disease. Healthy older adults with normal cognition are also needed.\n\nDesign:\n\nParticipants will be screened. They will have a test of their heart function and an imaging scan. They will have mental health screening and tests of their thinking and memory. They will practice brain-training tasks on a tablet.\n\nParticipants will be divided into 2 groups: 1 will have cognitive training plus psilocybin; 1 will have cognitive training only.\n\nThose having cognitive training only will have 5 or 6 clinic visits. They will take the tablet home to practice brain training daily. They will wear a device to measure brain waves as they sleep; they may have 1 overnight stay in the clinic, or they may wear the device at home. Imaging scans and other tests will be repeated at each visit.\n\nThose taking psilocybin will have up to 9 clinic visits. In addition to the visits for cognitive training, they will take 1 psilocybin capsule by mouth 2 weeks apart (the second dose is optional). They will remain in the clinic for 24 hours after each dose.","conditions":["Alzheimer's Disease"],"keywords":["Aging","Psilocybin","Cognitive Training"],"interventions":[{"type":"DRUG","name":"Psilocybin"},{"type":"OTHER","name":"Cognitive Training"}],"enrollment":200,"startDate":"2026-11-15","completionDate":"2030-12-31","sex":"ALL","minAge":"65 Years","maxAge":"120 Years","healthyVolunteers":true,"eligibilityRaw":"* Pending Web Eligibility","locations":[{"facility":"National Institute of Aging, Clinical Research Unit","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sierra D Kunkosi","phone":"(410) 350-3941","email":"sierra.kunkoski@nih.gov"},{"name":"Dimitrios I Kapogiannis, M.D.","phone":"(667) 391-0063","email":"kapogiannisd@mail.nih.gov"}],"primaryOutcomes":["Determine whether psilocybin enhances neuroplasticity (Neuroplasticity Composite Score (NPCS))"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":["psilocybin"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 2: testing Psilocybin for Alzheimer's Disease","inPlainEnglish":"Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking. Researchers want to know if regular mental tasks (cognitive training) can improve brain function in older adults.","whoItsFor":["Ages 65 Years to 120 Years","Pending Web Eligibility"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Psilocybin, or Cognitive Training. The registry lists allocation as randomized. Background: Normal aging, as well as dementias such as Alzheimer s disease, can cause changes in the brain that affect memory, attention, and thinking.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 200 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.317Z"},{"nctId":"NCT07723963","title":"A Study to Evaluate the Safety and Efficacy of JZP926 Capsule for the Treatment of Juvenile Myoclonic Epilepsy","officialTitle":"A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of JZP926 in Participants Aged 10 Years and Older for the Treatment of Juvenile Myoclonic Epilepsy","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Jazz Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is being conducted to evaluate the safety and efficacy of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).","conditions":["Juvenile Myoclonic Epilepsy"],"keywords":["Juvenile myoclonic epilepsy","JME","JZP926 capsule"],"interventions":[{"type":"DRUG","name":"JZP926 capsule"},{"type":"DRUG","name":"Placebo"}],"enrollment":260,"startDate":"2026-09-18","completionDate":"2028-08-01","sex":"ALL","minAge":"10 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Is ≥ 10 years of age at the time of screening.\n2. Has a diagnosis of JME per ILAE criteria as specified in the protocol.\n3. Has at least 4 myoclonic seizure days per 28 days historical seizure frequency.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Presence of seizure types other than GTC, myoclonic, and absence seizures.\n2. If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other than JME.\n3. Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the efficacy measures, in the opinion of the investigator.\n4. The etiology of the participant's seizures is a progressive neurologic disease.\n5. Has clinically unstable or progressive epilepsy.\n6. Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders.\n7. Has a history of status epilepticus in the 3 months prior to screening.\n8. History of suicidal behavior, current suicidal risk as determined from history, or presence of active suicidal ideation as indicated by a positive response to Item 4 or Item 5 on the C-SSRS or is considered at risk of suicide or self-harm based on the clinical judgement of the investigator following interview with the participant and/or caregiver.\n9. Has known or suspected hypersensitivity to cannabinoids or any of the excipients of the study intervention.\n10. Is currently treated with Epidiolex or recently received treatment with Epidiolex within 28 days prior to screening.\n11. Has a body weight \\< 20 kg or \\> 150 kg.\n12. Is currently using or has used recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) within 28 days prior to screening.\n13. Is unwilling or unable to abstain from recreational or medicinal cannabis, cannabinoid/CBD based medications, products, or supplements (botanical or synthetic) for the duration of the study.","locations":[{"facility":"Banner University Medical Center","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCLA Mattel Children's Hospital","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sutter Health","city":"Sacramento","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yale University","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pediatric Epilepsy & Neurology Specialists","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emory Healthcare","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Savannah Neurology Specialists","city":"Savannah","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hawaii Pacific Neuroscience, LLC","city":"Honolulu","state":"Hawaii","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Consultants in Epilepsy and Neurology","city":"Boise","state":"Idaho","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwesthern Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bluegrass Epilepsy Research","city":"Lexington","state":"Kentucky","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Corewell Health","city":"Grand Rapids","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Saint Peter's University Hospital","city":"New Brunswick","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Health Physicians","city":"Hawthorne","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwell Health - Division of Pediatric Neurology","city":"Lake Success","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Weill Cornell Medicine - Pediatric Neurology","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Scottish Rite Hospital","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Carilion Clinic Neurology","city":"Roanoke","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sentara Neurology Specialists","city":"Virginia Beach","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Winchester Neurological Consultants","city":"Winchester","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trial Disclosure & Transparency","phone":"215-832-3750","email":"ClinicalTrialDisclosure@JazzPharma.com"}],"primaryOutcomes":["Change from baseline in myoclonic seizure days per 28 days (Part A and Part B)"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","los-angeles-california","sacramento-california","new-haven-connecticut","tampa-florida","atlanta-georgia","savannah-georgia","honolulu-hawaii","boise-idaho","chicago-illinois","lexington-kentucky","grand-rapids-michigan","new-brunswick-new-jersey","hawthorne-new-york","lake-success-new-york","new-york-new-york","cincinnati-ohio","portland-oregon","philadelphia-pennsylvania","dallas-texas","roanoke-virginia","virginia-beach-virginia","winchester-virginia"],"enrichment":{"headline":"Phase 2 / Phase 3: testing JZP926 capsule for Juvenile Myoclonic Epilepsy","inPlainEnglish":"This study is being conducted to measure the safety and how well it works of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).","whoItsFor":["Ages 10 Years to any","Participants are eligible to be included in the study only if all of the following criteria apply:","Is ≥ 10 years of age at the time of screening","Has a diagnosis of JME per ILAE criteria as specified in the protocol","Has at least 4 myoclonic seizure days per 28 days historical seizure frequency"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Presence of seizure types other than GTC, myoclonic, and absence seizures","If historical MRI has been performed, participant's MRI reveals a cause of epilepsy other than JME","Has a concurrent, confirmed diagnosis of non-epileptic seizures or events that can confound the assessment of the how well it works measures, in the opinion of the investigator","The etiology of the participant's seizures is a progressive neurologic disease","Has clinically unstable or progressive epilepsy","Has clinically significant unstable medical condition(s), other than epilepsy, including unstable psychiatric disorders"],"whatHappens":"If you join, the listed intervention(s) are JZP926 capsule, or Placebo. The registry lists allocation as randomized. This study is being conducted to measure the safety and how well it works of JZP926 capsule in participants with Juvenile Myoclonic Epilepsy (JME).","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 260 people at 23 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.904Z"},{"nctId":"NCT07725939","title":"A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) With Chronic Bronchitis","officialTitle":"A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Study Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis (SCALA)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"UCB Biopharma SRL","sponsorClass":"INDUSTRY","summary":"The purpose of the study is to investigate the efficacy of galvokimig versus placebo in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.","conditions":["Chronic Obstructive Pulmonary Disease With Chronic Bronchitis"],"keywords":["Phase 2","COPD","SCALA","Galvokimig","UCB9741","Chronic bronchitis","AECOPD"],"interventions":[{"type":"BIOLOGICAL","name":"Galvokimig"},{"type":"BIOLOGICAL","name":"Placebo"}],"enrollment":402,"startDate":"2026-07-27","completionDate":"2029-06-29","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Participant must be aged ≥40 to ≤80 years of age, inclusive, at the time of signing the Informed Consent form (ICF)\n* Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype\n* Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of:\n\n  • long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)\n* Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening\n* Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening\n* Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit\n* Participant can be male or female.\n\n  * A male participant must agree to use contraception during the Intervention Periods and for at least 60 days after the final dose of study intervention and refrain from donating sperm during this period\n  * A female participant is eligible to participate if she is not pregnant not breastfeeding, and at least one of the following conditions applies:\n\n    * Not a women of childbearing potential (WOCBP) OR\n    * A WOCBP who agrees to follow the contraceptive guidance during the Intervention Periods and for at least 60 days after the final dose of study intervention\n* Participant is a current or ex-smoker (with tobacco smoking history of ≥10 pack-years)\n\nExclusion criteria:\n\n* Participant has any history or presence of any medical or psychiatric condition, physical examination finding, laboratory test result, or electrocardiogram (ECG) signal that, in the opinion of the investigator, could constitute a risk when taking the study intervention; or interfere with the interpretation of data and could jeopardize or would compromise the study participant's ability to participate in this study\n* Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening\n* Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)\n* Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior\n* Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline\n* Participant has clinically important pulmonary disease other than COPD with chronic bronchitis\n* Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)\n* Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study\n* Participant has relevant safety events to one or more interleukin (IL)-13 or IL-17 biologic response modifiers that resulted in discontinuation and change of treatment\n* Participant has absolute neutrophil count (ANC) \\<1.5 × 10³/μL\n* Participant has a corrected QT interval (QTc) \\>450msec for male participants or QTc \\>470msec for female participants or QTc \\>480 msec in participants with bundle branch block\n* Participant has a history of past or current chronic alcohol or drug abuse within the previous 12 months","locations":[{"facility":"Copd01 50021","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50016","city":"Westminster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50011","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50008","city":"Rincon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50017","city":"Charlotte","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50003","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50019","city":"Medford","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50002","city":"DuBois","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50020","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50004","city":"Rock Hill","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50009","city":"Spartanburg","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50010","city":"Union","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50001","city":"Boerne","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50006","city":"McKinney","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50005","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 50013","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20001","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20004","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20006","city":"Guangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20003","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20005","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20002","city":"Nanchang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20008","city":"Shenzhen","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20012","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20015","city":"Yangzhou SHI","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Copd01 20007","city":"Zhanjiang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"UCB Cares","phone":"1-844-599-2273 (USA)","email":"ucbcares@ucb.com"},{"name":"UCB Care","phone":"0018445992273","email":"ucbcares@ucb.com"}],"primaryOutcomes":["Time from treatment assignment to first moderate or severe acute exacerbation of chronic obstructive pulmonary disease (AECOPD)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["encino-california","westminster-california","miami-florida","rincon-georgia","charlotte-north-carolina","columbus-ohio","medford-oregon","dubois-pennsylvania","north-charleston-south-carolina","rock-hill-south-carolina","spartanburg-south-carolina","union-south-carolina","boerne-texas","mckinney-texas","tomball-texas","seattle-washington","beijing-china","chengdu-china","guangzhou-china","hangzhou-china","nanchang-china","shenzhen-china","shijiazhuang-china","yangzhou-shi-china","zhanjiang-china"],"enrichment":{"headline":"Phase 2: testing Galvokimig for Chronic Obstructive Pulmonary Disease With Chronic Bronchitis","inPlainEnglish":"The purpose of the study is to investigate the how well it works of galvokimig versus dummy treatment (placebo) in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.","whoItsFor":["Ages 40 Years to 80 Years","Participant with a documented physician-diagnosed moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) with chronic bronchitis phenotype","Participant has a documented record of receiving maintenance inhaled therapy at a stable dose for ≥3 months prior to Screening comprised of:","long-acting beta2 agonist (LABA) +long-acting muscarinic antagonist (LAMA) ±inhaled corticosteroid (ICS)","Participant at a high risk of exacerbations, defined as a documented exacerbation history of ≥2 moderate or severe acute exacerbation(s) of chronic obstructive pulmonary disease (AECOPD) in the 12 months prior to Screening or 1 severe AECOPD in the 6 months prior to Screening","Participant has a Chronic Airways Assessment Test (CAAT) score of ≥15 at Screening","Participant has acceptable inhaler and spirometry techniques according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines during the Screening Visit","Participant can be male or female"],"whoShouldSkip":["Participant has a history of uncompensated heart failure, fluid overload, or myocardial infarction, or evidence of new onset ischemic heart disease or in the opinion of the investigator other serious cardiac disease, within 12 months prior to Screening","Participant has a presence or a family history (first degree) of inflammatory bowel disease (IBD)","Participant has uncontrolled neuropsychiatric disorder, active suicidal ideation, or positive suicidal behavior","Participant has a history of chronic or recurrent clinically significant infections, or a serious extrapulmonary infection within the 6 months prior to Baseline","Participant has clinically important pulmonary disease other than COPD with chronic bronchitis","Participant has hypercapnia requiring bilevel positive airway pressure (BiPAP)","Participant has had a live or attenuated vaccines within 4 weeks prior to Screening or plans to receive such vaccines during the study"],"whatHappens":"If you join, the listed intervention(s) are Galvokimig, or Placebo. The registry lists allocation as randomized. The purpose of the study is to investigate the how well it works of galvokimig versus dummy treatment (placebo) in the time to the first acute exacerbation of chronic obstructive pulmonary disease (AECOPD) in study participants with moderate-to-severe COPD with chronic bronchitis.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 402 people at 26 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.654Z"},{"nctId":"NCT07726082","title":"Micro-choice-based Intervention for Multicausal Fatigue","officialTitle":"Micro-choice-based Intervention for Multicausal Fatigue: Proof of Concept Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital, Basel, Switzerland","sponsorClass":"OTHER","summary":"This proof-of-concept study aims to evaluate the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.","conditions":["Multicausal Fatigue","Fatigue","Post COVID Condition","Long COVID Syndrome","Postviral Fatigue"],"keywords":["neuroplastic therapy","group intervention"],"interventions":[{"type":"BEHAVIORAL","name":"Micro-choice-based intervention"}],"enrollment":24,"startDate":"2026-08-13","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)\n\nExclusion Criteria:\n\n* Have insufficient proficiency in German to complete study-related questionnaires\n* Lack the cognitive capacity to understand study procedures (e.g. due to dementia)\n* Present with severe medical conditions that may interfere with participation (e.g., advanced organ failure, uncontrolled inflammatory or autoimmune diseases, or severe psychiatric disorders)\n* Have active cancer or are currently undergoing cancer treatment\n* Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:\n\n  1. Need for a level of individual therapeutic support that exceeds what can be provided in a group setting; b) Refusal to engage in group-based therapy; c) Personality traits that are considered incompatible with group dynamics; d) Failure to attend the mandatory preparatory webinar (no-show is considered a no-go); e) Other significant reasons as determined by the therapeutic team)","locations":[{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Katrin Bopp, Dr.","phone":"+41 61 265 50 05","email":"katrin.bopp@usb.ch"}],"primaryOutcomes":["Retention rate"],"hasResults":false,"conditionSlugs":["long-covid"],"drugSlugs":[],"locationSlugs":["basel-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: Micro-choice-based intervention for Multicausal Fatigue","inPlainEnglish":"This proof-of-concept study aims to measure the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.","whoItsFor":["Ages 18 Years to 65 Years","\\- Experiencing persistent fatigue with a significant impact on daily functioning (Chalder Fatigue- Scale bimodal ≥ 4)"],"whoShouldSkip":["Have insufficient proficiency in German to complete study-related questionnaires","Lack the cognitive capacity to understand study procedures (e.g. due to dementia)","Present with severe medical conditions that may interfere with participation (e.g., advanced organ failure, uncontrolled inflammatory or autoimmune diseases, or severe psychiatric disorders)","Have active cancer or are currently undergoing cancer treatment","Are deemed incompatible with group participation during the preparation phase, based on a team assessment. Reasons for exclusion based on group incompatibility include:"],"whatHappens":"If you join, the listed intervention(s) are Micro-choice-based intervention. The registry lists allocation as na. This proof-of-concept study aims to measure the feasibility, acceptability, and potential benefits of a novel multimodal approach: the micro-choice-based intervention.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 24 people at Basel. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.244Z"},{"nctId":"NCT07726342","title":"SMP-656 for HER2-Positive Advanced Breast Cancer","officialTitle":"A Randomized, Open-Label, Dose-Optimization Phase II Clinical Trial to Evaluate the Efficacy and Safety of Single-Agent SMP-656 in Patients With HER2-Positive Locally Advanced or Metastatic Breast Cancer Who Progressed After Prior Treatment With HER2-Targeted Topoisomerase Inhibitor ADCs","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Chengdu SciMount Pharmatech Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are:\n\nWhat is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks.\n\nParticipants will:\n\nComplete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies","conditions":["HER2-positive Breast Cancer","Metastatic Breast Cancer","Locally Advanced Breast Cancer (LABC)"],"keywords":["SMP-656","Randomized Open-Label Trial","HER2","Antibody-Drug Conjugate","Trastuzumab Deruxtecan resistant","Phase II Trial","Dose Optimization","Topoisomerase Inhibitor","Metastatic Breast Cancer"],"interventions":[{"type":"DRUG","name":"SMP-656 Injection"},{"type":"DRUG","name":"SMP-656 Injection"}],"enrollment":60,"startDate":"2026-08-10","completionDate":"2027-07-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Voluntarily participate in this clinical trial, understand and comply with study procedures, and provide written informed consent voluntarily.\n2. Female patients aged ≥ 18 years at the time of signing the informed consent form.\n3. Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of hormone receptor (HR) status.\n4. HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ with positive fluorescence in situ hybridization (FISH+) results.\n5. Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior treatment with one TOP inhibitor ADC targeting HER2 (e.g., DS-8201 and other ADCs with topoisomerase inhibitor payloads), and have experienced disease progression.\n\n1\\) Endocrine monotherapy is excluded from the abovementioned standard therapy lines; 2) Disease recurrence occurring within 12 months following neoadjuvant or adjuvant chemotherapy will be regarded as progression after first-line standard therapy; 6. Have at least one measurable target lesion per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) .\n\n7\\. ECOG performance status 0-1. 8. Expected survival ≥ 3 months. 9. Bone marrow, hepatic, renal and coagulation function shall be deemed adequate based on laboratory tests performed within 7 days prior to the first dose of the investigational product. Blood transfusion or growth factor supportive therapy is prohibited within 14 days before the first administration of the investigational product：\n\n* Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 80 × 10⁹/L; hemoglobin (Hb) ≥ 90 g/L;\n* Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total serum bilirubin (TBIL) ≤ 1.5 × ULN, with the following exceptions;\n* For participants with confirmed liver metastases: AST and/or ALT ≤ 5 × ULN;\n* For participants diagnosed with Gilbert's syndrome: TBIL ≤ 3 × ULN;\n* Serum albumin ≥ 30 g/L;\n* Renal function: Creatinine clearance (CrCL) ≥ 50 mL/min (calculated via the Cockcroft-Gault formula), OR serum creatinine ≤ 1.5 × ULN;\n* Coagulation function: International Normalized Ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n  10\\. Women of childbearing potential (WOCBP) must agree to use highly effective contraception or maintain abstinence from the time of informed consent signature through 6 months after the last administration of the investigational product；For WOCBP, serum pregnancy testing performed within 7 days prior to the first dose of the investigational product must yield a negative result.\n\nExclusion Criteria:\n\n1. Patients with inflammatory breast cancer.\n2. Have received eribulin in prior lines of therapy.\n3. Have received prior treatment with an ADC with a tubulin inhibitor payload for recurrent or metastatic disease following prior treatment with an ADC with a topoisomerase inhibitor payload.\n4. Prior anti-tumor therapy consisting of utidelone or vinca alkaloids as the last regimen.\n5. Patients with a known history of severe hypersensitivity to inetetamab, SMP-656, or any of their excipients.\n6. Patients with meningeal metastases.\n7. Patients with active central nervous system (CNS) metastases are excluded, with the following exception: symptomatic CNS metastases limited to supratentorial region and/or cerebellum (i.e., no midbrain, pons, medulla oblongata or spinal cord metastases) that have received local therapy, with neurological symptoms stabilized for at least 2 weeks prior to the first dose of investigational product, and no requirement for steroid therapy or receiving prednisone ≤10 mg/day (or equivalent corticosteroids).\n8. Patients diagnosed with any other malignancy (other than the study tumor type) within 5 years prior to the first dose of the investigational product, except curatively treated localized malignancies such as basal cell carcinoma of the skin.\n9. History of interstitial lung disease (ILD) requiring corticosteroid intervention; current or suspected ILD; or has evidence of clinically significant active pneumonia at screening; or has active radiation pneumonitis requiring ongoing medical therapy; or has other severe pulmonary disease impairing respiratory function.\n10. Patients with a clinically significant history of cardiovascular disease, including but not limited to： (1) Left ventricular ejection fraction (LVEF) \\< 50%; congestive heart failure with New York Heart Association (NYHA) functional class \\> 2; (2) Have experienced myocardial infarction, unstable angina, severe pericardial disease or severe myocardial disease within the previous 6 months; (3) Presence of cardiac valve regurgitation or stenosis requiring therapeutic intervention; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention; poorly controlled malignant arrhythmias despite medication; complete left bundle branch block, second-degree or third-degree atrioventricular block; (5) QTc interval \\> 470 ms at screening (for female participants), or known family history of long QT syndrome; (6) Uncontrolled hypertension (defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite antihypertensive medication, or prior history of hypertensive crisis or hypertensive encephalopathy).\n11. History of arterial or venous thromboembolic events within 6 months prior to the first dose of the investigational product, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism.\n12. Participants with uncontrollable pleural effusion, pericardial effusion or ascites as judged by the Investigator, which requires repeated drainage once every two weeks or more frequently. Participants with indwelling pleural catheters are permitted to enroll.\n13. Have received live attenuated vaccines within 4 weeks prior to the first dose of the investigational produc, or plan to receive live attenuated vaccines during the study.\n14. Patients with severe infection within 4 weeks prior to the first dose of the investigational product, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infection with CTCAE Grade ≥2 requiring systemic antibiotic therapy within 2 weeks before the first dose (prophylactic antibiotics excluded) .\n15. Patients meeting any of the following criteria will be excluded: patients with active hepatitis B or hepatitis C；For patients positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), enrollment is permitted only if quantitative hepatitis B virus DNA (HBV-DNA) is below the upper limit of normal (ULN) of the study site laboratory；For patients positive for hepatitis C antibody (HCV-Ab), enrollment is permitted only if HCV RNA is below the ULN of the study site laboratory；Positive human immunodeficiency virus (HIV) antibody test; active syphilis infection; active tuberculosis infection.\n16. Patients with unresolved prior anti-tumor treatment-related toxicities (alopecia excluded) remaining at Grade \\>1 or not recovered to baseline, except adverse events (AEs) deemed not to pose a safety risk by the Investigator.\n17. Patients with Grade ≥2 peripheral neuropathy; or prior history of Grade ≥3 neurotoxicity / peripheral neuropathy; or permanent discontinuation of previous anti-tumor treatment due to neurotoxicity or peripheral neuropathy.\n18. Patients with a history of allogeneic stem cell transplantation or solid organ transplantation, or those planning to receive allogeneic stem cell transplantation or solid organ transplantation during the study.\n19. Patients who have participated in any other clinical trial within 4 weeks or 5 half-lives prior to the first dose of the investigational product, whichever is shorter.\n20. Patients who received radiotherapy within 4 weeks prior to the first dose of the investigational product are excluded, except palliative radiotherapy administered for symptom control within 2 weeks before the first dose of investigational product.\n21. Patients who received systemic anti-tumor therapy within 4 weeks prior to the first dose of the investigational product are excluded, except for the following： 1) Enrollment is permitted only if at least 6 weeks have elapsed between the completion of prior nitrosourea or mitomycin chemotherapy and the first dose of the investigational product; 2) Enrollment is allowed only if a minimum of 1 week has passed between the discontinuation of prior small-molecule targeted therapy and the first dose of the investigational product; 3) Enrollment is permitted only if a minimum of 2 weeks have elapsed between discontinuation of prior traditional Chinese medicine with anti-tumor effects and the first dose of the investigational product.\n22. articipants who have undergone major surgery within 4 weeks prior to the first dose of the investigational product, or are expected to receive major surgery during the study period (diagnostic surgery excluded); those who received diagnostic or minimally invasive surgery within 1 week before the first dose are also excluded.\n23. Patients requiring long-term treatment with corticosteroids or immunosuppressive agents (e.g., active autoimmune diseases requiring systemic therapy). Replacement therapies such as thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency are permitted.\n24. Prior documented history of neurological or psychiatric disorders, including epilepsy or dementia.\n25. Female Patients who are pregnant, breastfeeding, or planning to become pregnant during the study.\n26. Patients with severe concomitant diseases that may compromise patient safety or interfere with study completion as judged by the Investigator (e.g., severe hypertension, diabetes mellitus, thyroid disorders), or any other conditions deemed inappropriate for study participation by the Investigator.","locations":[{"facility":"The Second Affiliated Hospital of Anhui Medical University","city":"Hefei","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Cancer Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cancer Hospital, Chinese Academy of Medical Sciences","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Hospital of Hebei Medical University","city":"Shijiazhuang","state":"Hebei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Henan Provincial People's Hospital","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhongnan Hospital of Wuhan University","city":"Wuhan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhongda Hospital, Southeast University","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Liaoning Cancer Hospital & Institute","city":"Shenyang","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shandong Cancer Hospital and Institute","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Jiaotong University","city":"Xi’an","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital & Institute","city":"Chengdu","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaoxia Li","phone":"86-15308035028","email":"xiaoxial@xilinglab.com"}],"primaryOutcomes":["Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)","Recommended Dose in Pivotal Clinical Trials"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":["trastuzumab-deruxtecan"],"locationSlugs":["hefei-china","beijing-china","guangzhou-china","shijiazhuang-china","zhengzhou-china","wuhan-china","changsha-china","nanjing-china","shenyang-china","jinan-china","xian-china","chengdu-china","hangzhou-china"],"enrichment":{"headline":"Phase 2: testing SMP-656 Injection for HER2-positive Breast Cancer","inPlainEnglish":"The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also measure the safety of SMP-656 and identify the optimal dose for future trials.","whoItsFor":["Ages 18 Years to any","Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of hormone receptor (HR) status","HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ with positive fluorescence in situ hybridization (FISH+) results","Patients with HER2-positive locally advanced or metastatic breast cancer who have received prior treatment with one TOP inhibitor ADC targeting HER2 (e.g., DS-8201 and other ADCs with topoisomerase inhibitor payloads), and have experienced disease progression","Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 80 × 10⁹/L; hemoglobin (Hb) ≥ 90 g/L;","Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN); total serum bilirubin (TBIL) ≤ 1.5 × ULN, with the following exceptions;","For participants with confirmed liver metastases: AST and/or ALT ≤ 5 × ULN;","For participants diagnosed with Gilbert's syndrome: TBIL ≤ 3 × ULN;"],"whoShouldSkip":["Patients with inflammatory breast cancer","Have received eribulin in prior lines of therapy","Have received prior treatment with an ADC with a tubulin inhibitor payload for recurrent or metastatic disease following prior treatment with an ADC with a topoisomerase inhibitor payload","Prior anti-tumor therapy consisting of utidelone or vinca alkaloids as the last regimen","Patients with a known history of severe hypersensitivity to inetetamab, SMP-656, or any of their excipients","Patients with meningeal metastases","Patients diagnosed with any other malignancy (other than the study tumor type) within 5 years prior to the first dose of the investigational product, except curatively treated localized malignancies such as basal cell carcinoma of the skin"],"whatHappens":"If you join, the listed intervention(s) are SMP-656 Injection, or SMP-656 Injection. The registry lists allocation as randomized. The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at 15 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.360Z"},{"nctId":"NCT07727395","title":"INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy","officialTitle":"INtra-arterial AltEplase folloWing successfuL reperfusIoN After mEchanical Thrombectomy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"115 People's Hospital","sponsorClass":"OTHER_GOV","summary":"The NEWLINE trial is a multicenter, randomized, open-label, blinded endpoint (PROBE) trial evaluating whether adjunctive low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Eligible participants achieving successful reperfusion (eTICI 2b-3) within 24 hours of symptom onset will be randomized 1:1 to receive intra-arterial alteplase plus standard care or standard care alone. The primary outcome is excellent functional outcome (modified Rankin Scale score 0-1) at 90 days.","conditions":["Stroke, Acute Ischemic","Large Vessel Occlusion","Thrombectomy"],"keywords":["Intra-artery thrombolysis","successful reperfusion"],"interventions":[{"type":"DRUG","name":"Alteplase"},{"type":"DEVICE","name":"Endovascular thrombectomy"}],"enrollment":416,"startDate":"2026-08-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years old.\n2. No significant pre-stroke functional disability (pre-stroke mRS 0-1)\n3. Clinical diagnosis of acute ischemic stroke with anterior LVO\n4. Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to \"Last Known Well\" (LKW).\n5. Baseline NIHSS of 6 - 25\n6. Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8\n7. Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA)\n8. Treated with EVT resulting eTICI score of 2b-3. Patients with an eTICI score of 2b-3 on the diagnostic cerebral angiography before MT are also eligible for the study.\n9. Informed consent obtained from patient or acceptable patient surrogate.\n\nExclusion Criteria:\n\n1. mRS score ≥ 2 before stroke onset\n2. Anticipated advanced comorbid disease with life expectancy \\< 12 months\n3. Acute head trauma\n4. Severe hypertension with SBP \\> 185 mmHg or DBP \\> 110 mmHg and refractory to treatment.\n5. Any active or recent major bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 30 days.\n6. Contraindication to recombinant human tissue plasminogen activator (rt-PA) (except time to therapy).\n7. Women who are pregnant at stroke onset.\n8. Recent intracranial surgery in the past 30 days.\n9. Known genetic or acquired bleeding disposition with anticoagulation factor deficiency.\n10. Coagulation disorder with INR \\> 1.7 or use of new oral anticoagulants (within 48 hours of symptom onset).\n11. Platelet count \\< 50 G/L.\n12. Blood glucose \\< 2,8 mmol/L (50 mg/dl) or \\> 22,2 mmol/L (400 mg/dl)\n13. Known severe renal insufficiency with glomerular filtration rate \\< 30 ml/min or blood creatinine \\> 220 µmol/L (2,5 mg/dl).\n14. Requiring hemodialysis or peritoneal dialysis\n15. Suspected vascular occlusion as a result of infective endocarditis\n16. Suspected cerebral vasculitis based on medical history and/or angiographic evaluation.\n17. Suspected aortic dissection\n18. Severe allergy to contrast (non-mild rash allergy) or absolute contraindication to iodine contrast, heparin.\n19. Acute ischemic stroke with significant mass effect or evidence of midline shift on baseline neuroimaging, or clinical signs of brain herniation\n20. Suspected acute ischemic stroke involving multiple vascular territories or occlusion of two or more distinct vascular systems on neuroimaging\n21. Evidence of intracranial hemorrhage (including hemorrhagic transformation) on neuroimaging\n22. Brain tumor (with significant mass effect)\n23. Stent placement and other situations during the EVT procedure that requires antiplatelet therapy or anti coagulation within the first 24 hours.\n24. Extracranial segment occlusion of the ICA and post-procedural etiology suggests vascular dissection.\n25. Intravenous heparin administration (however, heparinised saline flushes are allowed)\n26. Procedure time \\> 90 min\n27. Number of thrombectomy passes \\> 5\n28. Complications occur during EVT: Vascular rupture, dissection, or contrast extravasation\n29. Complete clinical recovery after rapid recanalization.\n30. Participation in other interventional randomized clinical trials that may confound the outcome assessment of the study.\n31. Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).\n32. Unlikely to be available for 90-day follow-up","locations":[{"facility":"Chau Doc General Hospital","city":"An Giang","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kien Giang General Hospital","city":"An Giang","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Can Tho Central General Hospital","city":"Can Tho","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Da Nang Hospital","city":"Da Nang","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Viet Tiep Friendship Hospital","city":"Haiphong","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hanoi Medical University Hospital","city":"Hà Nội","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Military Hospital 103","city":"Hà Nội","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"175 Military Hospital","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"People's Hospital 115","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thong Nhat Hospital","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thu Duc General Hospital","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University Medical Center","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hue Central Hospital","city":"Huế","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thang H Nguyen, Assoc. Prof.","phone":"+84909982115","email":"nguyenhuythang115@gmail.com"},{"name":"Trung Q Nguyen, MsC","phone":"+84938477516","email":"quoctrungyds09@gmail.com"}],"primaryOutcomes":["Modified Rankin Scale at day 90","SAFETY OUTCOME: symptomatic intracerebral hemorrahge (sICH ) rate at 24 hours."],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["an-giang-vietnam","can-tho-vietnam","da-nang-vietnam","haiphong-vietnam","h-n-i-vietnam","ho-chi-minh-city-vietnam","hu-vietnam"],"enrichment":{"headline":"Phase 3: testing Alteplase for Stroke, Acute Ischemic","inPlainEnglish":"The NEWLINE trial is a multicenter, randomly assigned, open-label, blinded endpoint (PROBE) trial evaluating whether added on top of your current treatment low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion. Eligible participants achieving successful reperfusion (eTICI 2b-3) within 24 hours of symptom onset will be randomly assigned 1:1 to receive intra-arterial alteplase plus standard care or standard care alone.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years old","No significant pre-stroke functional disability (pre-stroke mRS 0-1)","Clinical diagnosis of acute ischemic stroke with anterior LVO","Time from symptom onset to randomization within 24 hours, including wake-up stroke or unwitness stroke; the onset time refers to \"Last Known Well\" (LKW)","Baseline NIHSS of 6 - 25","Non-contrast CT (NCCT) or diffusion-weighted imaging (DWI)-MRI Alberta Stroke Program Early CT Score (ASPECTS) ≥ 6. For patients with available perfusion imaging (CTP/MRP), additional criteria include: Ischemic core volume ≤ 70mL; Mismatch volume ≥ 15 ml; Mismatch ratio ≥ 1.8","Evidence of oclussion of the intracranial segment of the internal carotid artery (ICA), or M1 or M2 segment of the middle cerebral artery (MCA) on CT angiography (CTA) or MR angiography (MRA)"],"whoShouldSkip":["mRS score ≥ 2 before stroke onset","Anticipated advanced comorbid disease with life expectancy \\< 12 months","Severe hypertension with SBP \\> 185 mmHg or DBP \\> 110 mmHg and refractory to treatment","Any active or recent major bleeding (gastrointestinal, urinary tract bleeding, etc.) in the last 30 days","Contraindication to recombinant human tissue plasminogen activator (rt-PA) (except time to therapy)","Women who are pregnant at stroke onset","Recent intracranial surgery in the past 30 days"],"whatHappens":"If you join, the listed intervention(s) are Alteplase, or Endovascular thrombectomy. The registry lists allocation as randomized. The NEWLINE trial is a multicenter, randomly assigned, open-label, blinded endpoint (PROBE) trial evaluating whether added on top of your current treatment low-dose intra-arterial alteplase administered immediately after successful endovascular thrombectomy improves functional outcomes in adults with acute ischemic stroke due to anterior circulation large vessel occlusion.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 416 people at 13 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.219Z"},{"nctId":"NCT07727512","title":"PCOS and Brain Health","officialTitle":"Functional and Structural Impacts of Polycystic Ovary Syndrome (PCOS) on Brain Health","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"The purpose of this study is to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period.","conditions":["PCOS"],"keywords":["brain health","cerebral blood flow","polycystic ovarian syndrome","brain structure","cognition"],"interventions":[{"type":"DEVICE","name":"MRI Visit"},{"type":"OTHER","name":"Laboratory Visit"}],"enrollment":45,"startDate":"2026-08-07","completionDate":"2028-08","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria (Participants with PCOS):\n\n* Rotterdam criteria demonstrating two out of the three criteria. These are:\n\n  1. Presence of clinical hyperandrogenism or biochemical hyperandrogenism\n  2. A history of irregular menstrual cycles\n  3. Presence of polycystic ovarian morphology on ultrasound\n\nInclusion Criteria (Healthy Controls):\n\n* Regular menstrual cycles (not meeting criteria for irregular cycles above)\n* No diagnosis of PCOS\n* Controls may have isolated hirsutism or polycystic ovaries on ultrasound as long as they do not meet Rotterdam criteria for PCOS\n\nExclusion Criteria:\n\n* Current pregnancy\n* Preexisting diagnosis of type 1 diabetes\n* Severe obesity (body mass index (BMI) greater than 45kg/m2)\n* Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160/100 on two separate occasions during clinical care\n* History of neurologic disease or stroke\n* History of myocardial infarction or deep venous thrombosis\n* Endometriosis confirmed by prior laparoscopy\n* Autoimmune conditions including lupus, multiple sclerosis, and active malignancy\n* Immuno-modulating medications\n* Conditions incompatible with MRI scanning, including but not limited to\n\n  * Certain implanted metal devices or foreign bodies\n  * Severe claustrophobia\n* Post-menopausal\n* Participants will be excluded if they have taken hormonal contraception or fertility medication in the last month","locations":[{"facility":"University of Wisconsin","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sharon Blohowiak","phone":"(608) 262-5977","email":"sblohowiak@wisc.edu"}],"primaryOutcomes":["Cerebral Blood Flow (CBF) at rest","Circulating Sex Hormone Levels"],"hasResults":false,"conditionSlugs":["als","pcos"],"drugSlugs":[],"locationSlugs":["madison-wisconsin"],"enrichment":{"headline":"Not a traditional drug phase: MRI Visit for PCOS","inPlainEnglish":"This study wants to determine how polycystic ovary syndrome (PCOS) impacts overall brain health, such as cerebral blood flow (CBF), brain structure and connectivity, and cognitive performance. 45 reproductive aged (18-45 years) individuals with ovaries, with and without PCOS, will be enrolled to complete brain structure and CBF scans via magnetic resonance imaging (MRI) over 2 testing visits and can expect to be on study for approximately 5 hours over a 1 to 3 month period.","whoItsFor":["Ages 18 Years to 45 Years","Women only","(Participants with PCOS):","Rotterdam criteria demonstrating two out of the three criteria. These are:","Presence of clinical hyperandrogenism or biochemical hyperandrogenism","A history of irregular menstrual cycles","Presence of polycystic ovarian morphology on ultrasound","who can join (Healthy Controls):","Regular menstrual cycles (not meeting criteria for irregular cycles above)"],"whoShouldSkip":["Preexisting diagnosis of type 1 diabetes","Severe obesity (body mass index (body-mass index (BMI)) greater than 45kg/m2)","Preexisting diagnosis of hypertension requiring antihypertensive medication or blood pressure of greater than 160/100 on two separate occasions during clinical care","History of neurologic disease or stroke","History of myocardial infarction or deep venous thrombosis","Endometriosis confirmed by prior laparoscopy","Autoimmune conditions including lupus, multiple sclerosis, and active malignancy"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 45 people at Madison. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.792Z"},{"nctId":"NCT07729462","title":"A Study to Learn About the Study Medicine Called Rimegepant in Adults When Used for the Prevention of Chronic Migraine","officialTitle":"AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 3, DOUBLE-BLIND, RANDOMIZED, 2-ARM STUDY TO INVESTIGATE THE PREVENTION OF CHRONIC MIGRAINE WITH RIMEGEPANT COMPARED WITH PLACEBO IN PARTICIPANTS 18 YEARS OF AGE OR OLDER","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.\n\nAfter a 28-day observation period without study intervention, eligible participants will be randomized in a 1:1 ratio to receive either rimegepant 75 mg orally disintegrating tablet (ODT) or matching placebo once daily for 12 weeks under double-blind conditions. Participants who remain eligible at the end of the double-blind treatment phase will enter a 12-week open-label treatment period, during which all participants will receive open-label rimegepant 75 mg once daily. During this period, participants may also take an additional rimegepant tablet for the acute treatment of breakthrough migraine attacks, up to 10 doses per month. A 28-day follow-up period completes the approximately 32-week study.\n\nThe primary objective of the study is to determine whether once-daily rimegepant is more effective than placebo in reducing monthly migraine days relative to the observation period in adults with chronic migraine. Secondary objectives include evaluating differences between rimegepant and placebo in migraine responder rates, headache severity, acute migraine medication use, quality of life, work productivity, cognitive functioning, and safety and tolerability.\n\nApproximately 400 adults aged 18 years or older with a diagnosis of chronic migraine for at least 1 year will be enrolled at multiple study sites.","conditions":["Preventive Treatment of Migraine"],"keywords":["Migraine Prevention"],"interventions":[{"type":"DRUG","name":"Rimegepant"},{"type":"DRUG","name":"Placebo"}],"enrollment":400,"startDate":"2026-08-26","completionDate":"2028-10-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female participants ≥18 years of age.\n* Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.\n* History of migraine for at least 1 year before screening.\n* Migraine onset before 50 years of age and chronic migraine onset before 65 years of age.\n* Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated.\n* During the 3 months prior to screening, an average of:\n* ≥15 monthly headache days (MHDs),\n* including ≥8 monthly migraine days (MMDs),\n* and ≥1 non-headache day per month.\n* Completion of the Observation Phase and fulfillment of all protocol-defined eligibility requirements prior to randomization.\n* Willing and able to comply with study procedures, including completion of the electronic diary.\n\nExclusion Criteria:\n\n* Prior use of rimegepant for migraine prevention.\n* History of treatment failure of:\n\n  * 2 gepants, or\n  * 2 CGRP-targeting biologics, or\n  * 1 gepant and ≥1 CGRP-targeting biologic.\n* Failure of \\>4 migraine preventive medications, including at least 2 with different mechanisms of action.\n* Any medical or psychiatric condition, or clinically significant laboratory abnormality, that in the investigator's judgment may increase risk to the participant or interfere with study participation or interpretation of results. This includes, but is not limited to, uncontrolled hypertension or a history of Raynaud's phenomenon.\n* Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study.\n* Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation.\n* Use of investigational products or participation in another clinical study within protocol-defined exclusion windows.\n* Any other condition that, in the opinion of the investigator or sponsor, would make study participation unsafe or compromise study conduct.","locations":[{"facility":"Clinical Endpoints","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hope Clinical Research","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neuro-Pain Research Center","city":"Fresno","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Neurology Offices of South Florida PLLC","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research-Winter Park","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Josephson Wallack Munshower Neurology,PC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Collective Medical Research","city":"Overland Park","state":"Kansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New England Regional Headache Center, Inc.","city":"Worcester","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Michigan Headache & Neurological Institute","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"StudyMetrix Research","city":"City of Saint Peters","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Papillion Research Center / Avacare","city":"Papillion","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Upstate Clinical Research Associates, LLC","city":"Williamsville","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hightower Clinical","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC.","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Neurology","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Clinical Trial Partners","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Highland Clinical Research","city":"Salt Lake City","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"Jerusalem","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change From Observation Phase in Monthly Migraine Days (MMDs) Over the Entire Double-Blind Treatment Phase"],"hasResults":false,"conditionSlugs":["migraine","als"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","canoga-park-california","fresno-california","los-angeles-california","boca-raton-florida","winter-park-florida","indianapolis-indiana","overland-park-kansas","worcester-massachusetts","ann-arbor-michigan","city-of-saint-peters-missouri","papillion-nebraska","williamsville-new-york","oklahoma-city-oklahoma","memphis-tennessee","austin-texas","dallas-texas","salt-lake-city-utah","jerusalem-israel","tel-aviv-israel"],"enrichment":{"headline":"Phase 3: testing Rimegepant for Preventive Treatment of Migraine","inPlainEnglish":"Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day. This study evaluates once daily rimegepant for the preventive treatment of chronic migraine.","whoItsFor":["Ages 18 Years to any","Male or female participants ≥18 years of age","Diagnosis of chronic migraine, with or without aura, according to International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria","History of migraine for at least 1 year before screening","Migraine onset before 50 years of age and chronic migraine onset before 65 years of age","Migraine attacks lasting 4 to 72 hours when untreated or unsuccessfully treated","During the 3 months prior to screening, an average of:","≥15 monthly headache days (MHDs),"],"whoShouldSkip":["Prior use of rimegepant for migraine prevention","History of treatment failure of:","2 CGRP-targeting biologics, or","1 gepant and ≥1 CGRP-targeting biologic","Failure of \\>4 migraine preventive medications, including at least 2 with different mechanisms of action","Pregnant, breastfeeding, planning to become pregnant, or planning to initiate breastfeeding during the study","Positive amphetamine screening result unless attributable to prescribed stimulant therapy that has been stable for at least 3 months prior to Visit 1 and is expected to remain stable throughout study participation"],"whatHappens":"If you join, the listed intervention(s) are Rimegepant, or Placebo. The registry lists allocation as randomized. Rimegepant is a calcitonin gene-related peptide (CGRP) receptor antagonist approved for the acute treatment of migraine attacks in adults and for the preventive treatment of episodic migraine in adults when administered every other day.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 21 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.304Z"},{"nctId":"NCT07732309","title":"A Study of ATG-201 in Adult Participants With Autoimmune Diseases","officialTitle":"A Phase I, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of ATG-201 in Adult Participants With Autoimmune Diseases","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Antengene Biologics Limited","sponsorClass":"INDUSTRY","summary":"This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.","conditions":["Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Sjogren's Disease","Autoimmune Diseases"],"keywords":[],"interventions":[{"type":"DRUG","name":"ATG-201"}],"enrollment":149,"startDate":"2026-09-26","completionDate":"2028-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Participants who give consent to this study participation and sign informed consent form.\n2. Participants at least 18 years of age inclusive at screening visit.\n3. Must be able to adhere to the study visit schedule and other protocol .requirements.\n4. Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening.\n5. Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment.\n\nExclusion Criteria:\n\n1. Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab).\n2. Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis.\n3. Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening.\n4. Severe (requiring oxygen support) or rapidly progressing interstitial lung disease.\n5. Uncontrolled other diseases: history or clinical evidence of active significant acute or chronic diseases (i.e., cardiovascular, pulmonary, untreated hypertension, anemia, gastrointestinal, hepatic, renal, neurological, cancer, or infectious diseases) which, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.\n6. History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant.\n7. Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study.\n8. Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\\>60 mg/day) within 2 months prior to screening.\n9. Live or attenuated vaccine within 28 days prior to screening or during screening.\n10. Participants who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months or who, in the investigator's opinion, pose a significant suicide risk.\n11. The participant has an abnormality on 12-lead electrocardiogram at screening which is clinically significant in the opinion of the investigator, and which could confound the results of the study.","locations":[{"facility":"The First Affiliated Hospital of Bengbu Medical University","city":"Bengbu","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of University of Science and Technology of China","city":"Hefei","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xiamen University","city":"Xiamen","state":"Fujian","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanfang Hospital of Southern Medical Universit","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sun Yat-sen Memorial Hospital, Sun Yat-sen Universit","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Guangzhou University of Chinese Medicine","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Third Affiliated Hospital of Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science and Technology","city":"Luoyang","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nuclear Industry General Hospital","city":"Suzhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Linyi People's Hospital","city":"Linyi","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital Affiliated to Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Shanxi Medical University","city":"Taiyuan","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xi'an Jiaotong University","city":"Xi’an","state":"Shanxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Iris Li","phone":"021-32501095","email":"iris.li@antengene.com"}],"primaryOutcomes":["Safety and TolerabilitySafety and Tolerability"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["bengbu-china","hefei-china","beijing-china","xiamen-china","guangzhou-china","luoyang-china","zhengzhou-china","wuhan-china","changsha-china","nanjing-china","suzhou-china","jinan-china","linyi-china","shanghai-china","taiyuan-china","xian-china","hangzhou-china"],"enrichment":{"headline":"Phase 1: testing ATG-201 for Systemic Lupus Erythematosus","inPlainEnglish":"This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.","whoItsFor":["Ages 18 Years to any","Participants at least 18 years of age inclusive at screening visit","Must be able to adhere to the study visit schedule and other protocol .requirements","Female of childbearing potential must agree to use adequate contraceptive measures from 28 days before starting study treatment to until 48 weeks after last dose of treatment, not breastfeeding, and have a negative serum pregnancy test at screening","Male participants must agree to use an effective barrier method of contraception during sexual contact with a female of childbearing potential during screening and throughout the study until 48 weeks after the final dose of study treatment"],"whoShouldSkip":["Intolerance or allergy to the investigational product, or to any component thereof, or to any concomitant medications that may be used in the study (e.g., tocilizumab)","Presence of central nervous system disorders of either autoimmune or non-autoimmune etiology, including but not limited to: epilepsy, psychotic disorders, organic brain syndrome, cerebrovascular accident, encephalitis, or central nervous system vasculitis","Catastrophic or severe antiphospholipid syndrome within 12 months prior to screening or during screening","Severe (requiring oxygen support) or rapidly progressing interstitial lung disease","History of a major organ transplant (e.g. heart, lung, renal, liver) or hematopoietic stem cell/marrow transplant","Have a planned surgical procedure, or a history of any other medical disease, or laboratory abnormalities, or conditions which would make the participant (in the opinion of the investigator) unsuitable for the study","Received intravenous immunoglobulin, plasmapheresis, hemodialysis, intravenous cyclophosphamide, or high dose prednisone and its equivalents (\\>60 mg/day) within 2 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are ATG-201. The registry lists allocation as na. This is a phase I, open-label study of ATG-201 in participants with autoimmune diseases.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 149 people at 22 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.958Z"},{"nctId":"NCT07733349","title":"Phase I/II Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease","officialTitle":"Phase I/II Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection in Patients With Parkinson's Disease","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Shanghai UniXell Biotechnology Co., Ltd","sponsorClass":"INDUSTRY","summary":"This clinical study is designed to explore the safety and tolerability of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.","conditions":["Parkinson's Disease"],"keywords":["allogeneic iPSC derived mDAPs","Parkinson's Disease"],"interventions":[{"type":"DRUG","name":"UX-DA003"}],"enrollment":12,"startDate":"2026-09-24","completionDate":"2029-08-31","sex":"ALL","minAge":"30 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged between 30 and 75 years, regardless of gender\n* Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years\n* Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined\n* Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%\n* The modified H\\&Y staging (Off period) of ≥2.5 and ≤4, with total daily \"off\" time \\>2 hours\n* Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening\n* Good physical condition or stable concomitant diseases\n\nExclusion Criteria:\n\n* The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome\n* Severe systemic diseases or functional impairments\n* Evidence of active infection or chronic infection, which may pose a risk to the subject\n* Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders\n* Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks\n* Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months\n* Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them\n* Pregnant or breastfeeding women","locations":[{"facility":"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jun Liu, MD, PhD","phone":"+86-21-64370045","email":"jly0520@hotmail.com"}],"primaryOutcomes":["Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing UX-DA003 for Parkinson's Disease","inPlainEnglish":"This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.","whoItsFor":["Ages 30 Years to 75 Years","Aged between 30 and 75 years, regardless of gender","Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years","Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the how well it works has significantly declined","Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%","The modified H\\&Y staging (Off period) of ≥2.5 and ≤4, with total daily \"off\" time \\>2 hours","Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening","Good physical condition or stable concomitant diseases"],"whoShouldSkip":["The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome","Severe systemic diseases or functional impairments","Evidence of active infection or chronic infection, which may pose a risk to the subject","Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders","Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other treatment clinical trials within the last 3 months","Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them","Pregnant or breastfeeding women"],"whatHappens":"If you join, the listed intervention(s) are UX-DA003. The registry lists allocation as na. This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 12 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.670Z"},{"nctId":"NCT07734038","title":"Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma","officialTitle":"A Phase Two Study of Venetoclax Plus Zanubrutinib in Newly Diagnosed CLL and After Front-Line Time-Limited Venetoclax-Based Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Kerry Rogers","sponsorClass":"OTHER","summary":"This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Zanubrutinib blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. It is a type of tyrosine kinase inhibitor. Giving venetoclax in combination with SOC zanubrutinib may be safe and tolerable and may reduce the number of cancer cells that remain in the body in patients with CLL or SLL that have not previously received treatment or at least two years have passed since completing initial treatment.","conditions":["Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Bone Marrow Aspiration"},{"type":"PROCEDURE","name":"Bone Marrow Biopsy"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"DRUG","name":"Venetoclax"},{"type":"DRUG","name":"Zanubrutinib"}],"enrollment":155,"startDate":"2026-09-16","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of CLL/SLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria\n* Age ≥ 18 years\n* Indications for treatment as defined by the iwCLL 2018 Guidelines\n* Received prior treatment or not depending on cohort\n\n  * Frontline cohort:\n\n    * CLL/SLL who are treatment-naïve and have met criteria 1 through 3 above\n  * Second line cohort:\n\n    * Must have received time-limited venetoclax based therapy in the front line. This is defined as treatment with venetoclax and an-anti-CD20 antibody, venetoclax and a BTKi, or treatment with venetoclax and a BTKi, and an anti-CD20 monoclonal antibody that was given for a fixed-duration. Patients who discontinue ibrutinib, due to intolerance, in a BTKi and venetoclax +/- obinutuzumab combination are eligible provided they completed other drugs in the regimen and in the opinion of the treating investigator the intolerance will not limit treatment with zanubrutinib and venetoclax. Patients who discontinued BTKi other than ibrutinib or who discontinued venetoclax due to intolerance will be excluded\n    * At least 2 years since completion of initial CLL treatment\n    * Only 1 prior line of therapy. Treatment with rituximab or other anti-CD20 monoclonal antibody for idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA) is not considered a prior line of CLL/SLL therapy\n* Eastern Cooperative Oncology Group (ECOG) performance 0-2\n* Absolute neutrophil count (ANC) \\> 1000/mm\\^3 (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL/SLL)\n* Platelets \\> 30,000/mm\\^3 at screening (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL/SLL)\n* Hemoglobin \\> 7 g/dL (independent of growth factor support at screening, unless cytopenias are due to marrow involvement by CLL/SLL)\n* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x the upper limit of normal (ULN) or ≤ 5 x ULN with documented liver involvement\n* Bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN with documented liver involvement and/or Gilbert's disease\n* Creatinine clearance (CrCl) ≥ 50 according to modified Cockcroft-Gault equation\n* Willing and able to complete study activities and treatment\n* Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol\n* Willingness of men and women of reproductive potential and their partners to observe conventional and highly effective or acceptable birth control methods for the duration of treatment and for 1 week following the last dose of zanubrutinib or 30 days following the last dose of venetoclax, whichever is longer\n\nExclusion Criteria:\n\n* Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment\n* Frontline arm only: Patients with deletion 17p and/or TP53 mutation\n* Active Richter's transformation\n* Prior zanubrutinib exposure\n* Known hypersensitivity to any of the excipients of zanubrutinib or venetoclax\n* Need for treatment with warfarin or other vitamin K antagonist during study treatment\n* History of stroke or intracranial hemorrhage within 6 months\n* Known bleeding diathesis\n* Inability to take pills or oral medications\n* Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption of either zanubrutinib or venetoclax\n* Active second malignancy unless in remission and with life expectancy \\> 2 years. Adjuvant endocrine therapy for breast or prostate cancer that is expected to be cured is allowed. Non-melanoma skin cancers are permitted if adequately treated\n* Psychiatric illness, or social situations that would limit compliance with study requirements\n* Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts\n* Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or other clinically significant active disease process which in the opinion of the investigator may pose a risk for patient participation. Screening for chronic conditions is not required\n* Significant cardiovascular disease defined as:\n\n  * Unstable angina or acute coronary syndrome within the past 2 months\n  * History of myocardial infarction within 3 months\n  * Documented left ventricular ejection fraction (LVEF) by any method of ≤ 40% within 12 months\n  * ≥ grade 3 New York Heart Association (NYHA) functional classification system of heart failure\n  * Uncontrolled or symptomatic arrhythmias\n\n    * Note: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n* Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF)\n\n  * Correction of suspected drug induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation\n  * Correction for underlying bundle branch block (BBB) allowed\n* Known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection based on criteria below:\n\n  * Hepatitis B virus (HBV): Patients with positive hepatitis B surface antibody (HBsAb) are not excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require hepatitis B polymerase chain reaction (PCR) evaluation before inclusion. Patients who are hepatitis B PCR positive at time of screening will be excluded. Those who have hepatitis B core antibody positive and a negative PCR will be included if they are agreeable to receive antiviral prophylaxis\n  * Hepatitis C virus (HCV): If hepatitis C antibody is positive, patients will need to have a negative result for hepatitis C ribonucleic acid (RNA) before inclusion. Patients who are hepatitis C RNA positive at time of screening will be excluded. Patients previously treated for hepatitis C \\> 6 months previously with a negative RNA test are eligible\n  * Patients who are receiving intravenous immunoglobulin (IVIG) who test positive for any hepatitis B or C serologies and have a negative PCR and who are deemed likely to have received antibodies passively through IVIG and not from prior infection will be included without viral prophylaxis\n* Treatment with a strong cytochrome P450 (CYP)3A inhibitor or inducer and/or strong P-glycoprotein (P-gp) inhibitors within 3 days of starting and during study treatment\n* Patients may not plan to consume grapefruit or grapefruit products, Seville oranges or products from Seville oranges, or star fruit\n* Pregnancy, lactation, or plan to breastfeed during treatment with or within 2 weeks of the last dose of zanubrutinib or 1 month of the last dose of venetoclax\n* Major surgery within 4 weeks prior to screening\n* Vaccination with live vaccine within 28 days of screening\n* Currently incarcerated\n* Current central nervous system involvement by CLL/SLL","locations":[{"facility":"Ohio State University Comprehensive Cancer Center","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"The Ohio State University Comprehensive Cancer Center","phone":"800-293-5066","email":"OSUCCCClinicaltrials@osumc.edu"}],"primaryOutcomes":["Rate of undetectable minimal residual disease (uMRD) (Firstline Cohort)","Rate of uMRD (Second Line Cohort)"],"hasResults":false,"conditionSlugs":["leukemia","lymphoma"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Phase 2: testing Venetoclax for Chronic Lymphocytic Leukemia","inPlainEnglish":"This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors.","whoItsFor":["Ages 18 Years to any","Diagnosis of CLL/SLL meeting criteria established in International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria","Indications for treatment as defined by the iwCLL 2018 Guidelines","Received prior treatment or not depending on cohort","CLL/SLL who are treatment-naïve and have met criteria 1 through 3 above","Second line cohort:","At least 2 years since completion of initial CLL treatment","Only 1 prior line of therapy. Treatment with rituximab or other anti-CD20 monoclonal antibody for idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA) is not considered a prior line of CLL/SLL therapy"],"whoShouldSkip":["Second line arm only: Patients who progressed per iwCLL 2018 criteria on therapy or within two years of completing time-limited, venetoclax based treatment","Frontline arm only: Patients with deletion 17p and/or TP53 mutation","Active Richter's transformation","Prior zanubrutinib exposure","Known hypersensitivity to any of the excipients of zanubrutinib or venetoclax","Need for treatment with warfarin or other vitamin K antagonist during study treatment","History of stroke or intracranial hemorrhage within 6 months"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Bone Marrow Aspiration, or Bone Marrow Biopsy. The registry lists allocation as randomized. This phase II trial tests the effect of venetoclax in combination with standard of care (SOC) zanubrutinib in treating patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 155 people at Columbus. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.819Z"},{"nctId":"NCT07734064","title":"A Study About the Safety of a Single ASP2020 Eye Injection and if it Helps People With Vision Loss From Stargardt-type Eye Conditions","officialTitle":"A Phase 1b, Open-label, Multicenter Dose-escalation Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Single Subretinal Dose of ASP2020 in Participants With Macular Dystrophies With a Stargardt-type Clinical Presentation","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Astellas Institute for Regenerative Medicine","sponsorClass":"INDUSTRY","summary":"Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye. In people with macular dystrophies, some of the cells in the macula gradually stop working and may die over time. This leads to loss of central vision, which can make it harder to read, recognize faces or see fine details. What's seen out of the corner of the eye (peripheral vision) is mostly unaffected. Stargardt disease (STGD) is a type of macular dystrophy which is caused by 1 faulty gene (ABCA4). Vision loss most typically begins in childhood or teenage years but may also develop in adulthood. As well as STGD, there are other macular dystrophies that look very similar to STGD and are called STGD-like macular dystrophies. These are caused by many other different genes. Together, STGD and STGD-like conditions can be called STGD-type macular dystrophies.\n\nThis is an early development study of ASP2020 in adults, teenagers, and children with STGD-type macular dystrophies. ASP2020 are human stem cells which have been changed into cells found in the macula. In this study ASP2020 will be given to people for the first time. The main aim of the study is to check the safety of ASP2020 and how well people tolerate it. Other aims are to learn if people have an immune reaction to ASP2020, and if there are signs that the stem cells replace damaged cells in the retina, and vision improves for people with STGD-type macular dystrophies.\n\nASP2020 will be given as a single injection into the eye, under the retina. This requires a surgical procedure where the person is put to sleep by a general anesthetic. At the end of surgery, a steroid will be injected into the eye to reduce any swelling.\n\nThe study has 2 parts. In Part 1, different small groups will receive a lower to higher dose of ASP2020. This is done to find a suitable dose to use in Part 2. The adults will receive the lower dose and higher dose before the teenagers. There will be a 6-month gap between the last adult receiving the lower dose of ASP2020 and the first teenager receiving the same lower dose. This will also happen for the last adult receiving the higher dose of ASP2020 and the first teenager receiving the higher dose of ASP2020. Any medical problems will be recorded for each dose in each group. Children will not receive ASP2020 in Part 1.\n\nIn Part 2, different groups of adults, teenagers and children will receive the most suitable dose of ASP2020 worked out from Part 1.\n\nPeople will be in the study for about 1 year and they will visit the clinic several times. In both parts of the study, safety checks will be done at each visit, and the study doctors will continue to check for any medical problems throughout the study. Various eye tests and eye imaging will be done throughout the study. Blood tests will also be done at some of the visits during the study.","conditions":["Stargardt Disease","Stargardt Macular Dystrophy","Stargardt-like Macular Dystrophy"],"keywords":["Macular Dystrophies","Stargardt type","ABCA4 related STGD","STGD-like macular dystrophies","Safety","STGD","STGD-like","STGD-type"],"interventions":[{"type":"DRUG","name":"ASP2020"}],"enrollment":30,"startDate":"2026-08-14","completionDate":"2029-09-30","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented clinical diagnosis of macular dystrophy with a STGD-type clinical presentation and molecular confirmation, defined as either:\n\n  * STGD: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD.\n  * STGD-like macular dystrophy: presence of one or more pathogenic variants in a gene known to cause macular dystrophy, as appropriate for its expected inheritance mode.\n* Sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures.\n* Intraocular pressure (IOP) of ≤ 21 mmHg\n* Participant has a spherical equivalent refractive error between +8.00 D and -10.00 D.\n* BCVA ranging from 20/500 to 20/40 (equivalent to 15 to 70 ETDRS letters)\n\n  * For participants in the \\> 20/80 to ≤ 20/40 BCVA range (moderate visual impairment \\[MVI\\]): presence of a visible definite or probable residual ellipsoid zone (EZ) on SD-OCT, and a total retinal SD-OCT central subfield thickness ≥ 150 micrometers (µm)\n  * For participants in the ≥ 20/500 to ≤ 20/80 BCVA range (severe visual impairment): Presence of a residual ONL within the macular optical coherence tomography (OCT) scan area and Evidence of RPE disease/damage by means of SD-OCT (hypertransmission defect) and/or FAF imaging (questionably decreased autofluorescence/definitely decreased autofluorescence).\n\nExclusion Criteria:\n\n* Participant has a known history of significant systemic disease that could impact ocular health or confound study assessments, based on medical history or prior clinical documentation.\n* Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and/or biologics that cause immunosuppression.\n* Participant has known diagnosis of diabetes mellitus with a documented glycated hemoglobin (HbA1c) value ≥ 7% 3 months prior to screening and based on available medical records.\n* Participant has a history or evidence of severe cardiac disease, cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening.\n* Participant has any complicating systemic disease or active malignancy.\n* Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments.\n* Participant has presence of another known or suspected molecular diagnosis of macular or retinal disease that could confound interpretation of study outcomes, indicate a second concomitant retinal condition, or suggest a different etiology for the macular disease.\n* Participant has macular atrophy due to any cause other than a genetically or clinically confirmed diagnosis of STGD or STGD-like macular dystrophy.\n* Participant has evidence or history of choroidal neovascularization.\n* Participant has diagnosis of any form of uncontrolled glaucoma (for high-tension glaucoma IOP \\> 25 mmHg).\n* Participant has a history of steroid-induced IOP elevation or known steroid responder status.\n* Participant has and/or is receiving treatment for thyroid eye disease.\n* Participant has diabetic retinopathy in excess of mild nonproliferative diabetic retinopathy\n* Participant has any other disease(s) affecting the optic nerve.\n* Participant has a history of anterior or posterior uveitis and/or presence of intraocular inflammation (trace anterior chamber cell or flare), or history of idiopathic or autoimmune-associated uveitis in either eye.\n* Participant has media opacities impeding the visualization of the fundus and/or the reliable performance of the visual function tests required by the protocol.\n* Participant has aphakia.\n* Participant has a clinically significant epiretinal membrane or evidence of clinically significant vitreomacular traction syndrome.\n* Participant has any other disorders which could interfere with or confound visual acuity and other ocular assessments, including OCT or FAF.\n* Participant has history of any of the following procedures: posterior vitrectomy, retinal detachment surgery, glaucoma filtering surgery, glaucoma drainage device implantation, selective laser trabeculoplasty, full-thickness or partial- thickness corneal transplant.\n* Participant has had any intraocular surgery within 3 months of screening.\n* Participant has a history of intraocular metallic foreign bodies.\n* Participant has received any treatment including gene therapy, stem cell therapy, surgical implantation of prosthetic retinal chips, or any prior intravitreal treatment for any indication in either eye that may be considered to potentially interfere with the study participation or its conduct.\n* Participant has received within 1 month prior to screening or is receiving concomitant treatment with any ocular or systemic medication known to be toxic to the lens, retina, or optic nerve.\n* Participant has received any investigational therapy within 3 months prior to screening.\n* Participant has any condition, which makes the participant unsuitable for study participation.","locations":[{"facility":"Associated Retina Consultants","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deep Blue Retina","city":"Southaven","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Eye Institute","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Foundation of Southwest","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Astellas Institute for Regenerative Medicine","phone":"800-888-7704","email":"Astellas.registration@astellas.com"}],"primaryOutcomes":["Number of participants with treatment-emergent adverse events (TEAEs)","Number of participants with serious adverse events (SAEs)","Number of participants with adverse events of special interest (AESIs)","Number of participants with greater than or equal to 15 letter loss in best corrected visual acuity (BCVA) from baseline","Number of participants with significant changes in vital signs from baseline","Number of participants with significant changes in laboratory values from baseline"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","southaven-mississippi","cincinnati-ohio","dallas-texas"],"enrichment":{"headline":"Phase 1: testing ASP2020 for Stargardt Disease","inPlainEnglish":"Macular dystrophies are a group of inherited eye conditions that affect the macula. The macula is in the center of the retina, the light sensitive part at the back of the eye.","whoItsFor":["Ages 6 Years to any","Documented clinical diagnosis of macular dystrophy with a STGD-type clinical presentation and molecular confirmation, defined as either:","STGD: presence of biallelic (pathogenic or likely pathogenic) ABCA4 variants, or one definite disease-causing ABCA4 variant together with a typical phenotype consistent with STGD","STGD-like macular dystrophy: presence of one or more pathogenic variants in a gene known to cause macular dystrophy, as appropriate for its expected inheritance mode","Sufficiently clear ocular media and adequate pupillary dilation to allow for all imaging procedures","Intraocular pressure (IOP) of ≤ 21 mmHg","Participant has a spherical equivalent refractive error between +8.00 D and -10.00 D","BCVA ranging from 20/500 to 20/40 (equivalent to 15 to 70 ETDRS letters)"],"whoShouldSkip":["Participant has a known history of significant systemic disease that could impact ocular health or confound study assessments, based on medical history or prior clinical documentation","Participant has an autoimmune condition that requires treatment with immunomodulatory therapy and/or biologics that cause immunosuppression","Participant has known diagnosis of diabetes mellitus with a documented glycated hemoglobin (HbA1c) value ≥ 7% 3 months prior to screening and based on available medical records","Participant has a history or evidence of severe cardiac disease, cardiovascular or cerebrovascular disease, including a history of stroke within 12 months prior to screening","Participant has any complicating systemic disease or active malignancy","Participant has a known history of any systemic or metabolic condition, or physical examination finding that may significantly affect ocular health or interfere with the interpretation of study assessments","Participant has presence of another known or suspected molecular diagnosis of macular or retinal disease that could confound interpretation of study outcomes, indicate a second concomitant retinal condition, or suggest a different etiology for the macular disease"],"whatHappens":"If you join, the listed intervention(s) are ASP2020. The registry lists allocation as randomized. Macular dystrophies are a group of inherited eye conditions that affect the macula.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.147Z"},{"nctId":"NCT07734857","title":"Peripheral Blood Biomarkers and Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma","officialTitle":"Peripheral Blood Biomarkers for Predicting Response to Atezolizumab Plus Bevacizumab in Hepatocellular Carcinoma: A Single-Center Prospective Observational Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Shanghai Zhongshan Hospital","sponsorClass":"OTHER","summary":"This single-center prospective observational cohort study aims to evaluate the predictive value of peripheral blood-based biomarkers for treatment response in patients with hepatocellular carcinoma (HCC) receiving first-line atezolizumab plus bevacizumab (T+A) therapy. Residual peripheral blood samples obtained during routine clinical testing will be analyzed without additional blood draws. The study hypothesizes that baseline and longitudinal peripheral blood biomarkers are associated with treatment response and can be used to identify patients more likely to benefit from T+A therapy. Treatment response will be evaluated based on the best overall response (BOR) during treatment. The primary efficacy assessment will be performed according to RECIST 1.1, while modified RECIST (mRECIST) will be used as a supportive assessment. Predictive models based on peripheral blood biomarkers will be developed using RECIST 1.1-defined treatment response as the primary analysis, with mRECIST used for supportive and sensitivity analyses.","conditions":["Hepatocellular Carcinoma (HCC)"],"keywords":[],"interventions":[{"type":"OTHER","name":"No intervention (observational study)"}],"enrollment":100,"startDate":"2026-09-01","completionDate":"2028-07-10","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-80 years\n* Histologically or clinically confirmed unresectable or advanced HCC, classified according to the BCLC staging system\n* Planned to receive first-line atezolizumab plus bevacizumab therapy, with no prior systemic therapy for unresectable or advanced HCC\n* At least one measurable target lesion with a longest diameter of ≥10 mm on CT or MRI according to RECIST 1.1, with mRECIST assessment performed when applicable\n* Availability of baseline and follow-up clinical and radiological data\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of another active malignancy, except for malignancies that have been curatively treated and remain recurrence-free\n* Prior systemic treatment with immune checkpoint inhibitors or anti-angiogenic agents for unresectable or advanced HCC\n* Expected inability to complete the required clinical or radiological follow-up assessments\n* Severe comorbid conditions that may interfere with study participation\n* No qualified residual blood sample available for planned biomarker analyses because of insufficient volume, contamination, loss, or other sample-related issues\n* Any condition deemed unsuitable for participation by the investigator","locations":[{"facility":"Zhongshan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Objective Response Rate"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: No intervention (observational study) for Hepatocellular Carcinoma (HCC)","inPlainEnglish":"This single-center prospective watch-and-measure (no experimental treatment required) cohort study aims to measure the predictive value of peripheral blood-based biomarkers for treatment response in patients with hepatocellular carcinoma (HCC) receiving first-line atezolizumab plus bevacizumab (T+A) therapy. Residual peripheral blood samples obtained during routine clinical testing will be analyzed without additional blood draws.","whoItsFor":["Ages 18 Years to 80 Years","Histologically or clinically confirmed unresectable or advanced HCC, classified according to the BCLC staging system","Planned to receive first-line atezolizumab plus bevacizumab therapy, with no prior systemic therapy for unresectable or advanced HCC","At least one measurable target lesion with a longest diameter of ≥10 mm on CT or MRI according to RECIST 1.1, with mRECIST assessment performed when applicable","Availability of baseline and follow-up clinical and radiological data"],"whoShouldSkip":["Presence of another active malignancy, except for malignancies that have been curatively treated and remain recurrence-free","Prior systemic treatment with immune checkpoint inhibitors or anti-angiogenic agents for unresectable or advanced HCC","Expected inability to complete the required clinical or radiological follow-up assessments","Severe comorbid conditions that may interfere with study participation","No qualified residual blood sample available for planned biomarker analyses because of insufficient volume, contamination, loss, or other sample-related issues","Any condition deemed unsuitable for participation by the investigator"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.618Z"},{"nctId":"NCT07734870","title":"Tirzepatide for Treatment of CCCA","officialTitle":"Tirzepatide for Treatment of CCCA","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are:\n\n* Does tirzepatide improve the symptoms and signs of active CCCA?\n* Does tirzepatide change the activity of genes in the scalp, especially genes related to scarring?\n* Does tirzepatide promote hair regrowth?\n\nParticipants will:\n\n* Inject tirzepatide once a week for 12 months.\n* Visit the clinic for scalp examinations, photographs, and other health assessments.\n* Have scalp biopsies at the beginning of the study and after 6 months of treatment.\n* Have blood tests and other safety monitoring during the study.\n\nThere is no separate comparison group. Researchers will compare each participant's results during treatment with the participant's results at the beginning of the study.","conditions":["Central Centrifugal Cicatricial Alopecia (CCCA)"],"keywords":["Scarring alopecia","Hair loss","Hair regrowth","Scalp fibrosis","Tirzepatide","Metabolic dysfunction","Insulin Resistance","Gene expression"],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":20,"startDate":"2026-09-15","completionDate":"2028-05-25","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Clinical and/or biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA).\n* Active CCCA, defined as a C-CAT disease activity score greater than 1.\n* No treatment for CCCA during the 6 weeks before enrollment.\n* Able and willing to complete the study and follow all study procedures.\n* Managed by a Johns Hopkins dermatologist throughout the study.\n\nExclusion Criteria:\n\n* Currently taking an oral or systemic blood glucose-lowering medication.\n* Currently taking another medication for weight loss.\n* Hemoglobin A1C below 5.4%.\n* Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below 2.\n* Body mass index below 19 kg/m².\n* Pregnant, breastfeeding, or planning a pregnancy.\n* Personal or family history of medullary thyroid cancer.\n* Personal or family history of multiple endocrine neoplasia type 2.\n* History of chronic kidney disease.\n* History of pancreatitis.\n* History of diabetic retinopathy.\n* Severe gastrointestinal disease.\n* Recent or planned major surgery.\n* Type 1 diabetes.\n* Any other contraindication to tirzepatide.\n* History of keloids or hypertrophic scarring.\n* History of poor wound healing.\n* History of a blood-clotting disorder.\n* Allergy to lidocaine or epinephrine.\n* Known sensitivity to local numbing medication.\n* Any significant medical condition that the investigator believes would make participation unsafe or prevent completion of the study.","locations":[{"facility":"Johns Hopkins Outpatient Center","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medical Pavilion at Howard County","city":"Columbia","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dakarai A Dunbar, BS","phone":"4435976380","email":"ddunbar7@jh.edu"},{"name":"Crystal U Aguh, M.D.","phone":"","email":"cagi1@jhmi.edu"}],"primaryOutcomes":["Change in Central Centrifugal Cicatricial Alopecia Clinical Activity Tool Score","Change in Scalp Gene-Expression Profiles"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["tirzepatide"],"locationSlugs":["baltimore-maryland","columbia-maryland"],"enrichment":{"headline":"Phase 2: testing Tirzepatide for Central Centrifugal Cicatricial Alopecia (CCCA)","inPlainEnglish":"The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults. The main questions it aims to answer are: * Does tirzepatide improve the symptoms and signs of active CCCA?","whoItsFor":["Ages 18 Years to 80 Years","Age 18 to 80 years","Clinical and/or biopsy-confirmed diagnosis of central centrifugal cicatricial alopecia (CCCA)","Active CCCA, defined as a C-CAT disease activity score greater than 1","No treatment for CCCA during the 6 weeks before enrollment","Able and willing to complete the study and follow all study procedures","Managed by a Johns Hopkins dermatologist throughout the study"],"whoShouldSkip":["Currently taking an oral or systemic blood glucose-lowering medication","Currently taking another medication for weight loss","Hemoglobin A1C below 5.4%","Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) score below 2","Body mass index below 19 kg/m²","Pregnant, breastfeeding, or planning a pregnancy","Personal or family history of medullary thyroid cancer"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. The goal of this pilot clinical trial is to learn if tirzepatide can treat active central centrifugal cicatricial alopecia (CCCA), a type of permanent scarring hair loss, in adults.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.022Z"},{"nctId":"NCT07735494","title":"Physical Activity Promotion and Clinical Remission in Severe Asthma","officialTitle":"Impact of Physical Activity Promotion on Clinical Remission in Adults With Severe Asthma Receiving Tezepelumab: A Multicentre, Open Label, Randomised Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Leeds","sponsorClass":"OTHER","summary":"This study will investigate whether a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases objectively measured physical activity and the proportion of adults with severe asthma achieving clinical remission compared with standard care alone. Although biologic therapies have improved asthma control for many people with severe asthma, many individuals remain physically inactive, experience reduced exercise tolerance, and continue to report symptoms that affect their quality of life. Physical inactivity may represent a modifiable factor that limits the achievement of optimal health outcomes.\n\nAdults with severe asthma who are starting tezepelumab as part of routine clinical care will be randomly assigned to receive either standard care alone or standard care plus a 12-week physical activity promotion programme. The programme includes an individual consultation, group behavioural support sessions, personalised goal setting, self-monitoring using a smartphone application, and strategies to help participants increase and maintain their physical activity levels. Participants will be followed for 12 months.\n\nThe study will primarily assess change in objectively measured daily step count after 3 months. The primary clinical outcome will be the proportion of participants achieving clinical remission after 12 months. Additional outcomes include asthma disease stability, asthma exacerbations, objectively measured physical activity at 12 months and functional exercise capacity. The findings will help determine whether combining physical activity promotion with biologic therapy improves outcomes for adults with severe asthma and could inform future models of routine severe asthma care.","conditions":["Severe Asthma"],"keywords":["Severe Asthma","Treatable Traits","Tezepelumab","Self-management","Behavioural Intervention"],"interventions":[{"type":"BEHAVIORAL","name":"Physical activity promotion"},{"type":"DRUG","name":"Tezepelumab"}],"enrollment":140,"startDate":"2026-07-31","completionDate":"2029-07-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18-70 years.\n* Physician-diagnosed severe asthma.\n* Eligible for tezepelumab according to NICE TA880.\n* History of ≥3 asthma exacerbations requiring oral corticosteroids in the previous 12 months or receiving maintenance oral corticosteroid therapy.\n* Objective confirmation of asthma, including bronchodilator reversibility, bronchial hyperresponsiveness and/or variable airflow obstruction, as part of routine clinical assessment.\n* Decision to commence tezepelumab made by the treating multidisciplinary severe asthma team prior to study enrolment.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Non-asthma respiratory disease that may confound study outcomes (e.g. obstructive sleep apnoea).\n* Pregnancy.\n* Significant non-asthma medical conditions likely to impair physical activity or functional exercise capacity (e.g. acute musculoskeletal injury).\n* Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study completion.","locations":[{"facility":"Leeds Teaching Hospitals NHS Trust","city":"Leeds","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Oliver J Price, PhD","phone":"+44(0)113 343 2909","email":"o.price1@leeds.ac.uk"},{"name":"Ian J Clifton, MD","phone":"","email":"i.clifton@nhs.net"}],"primaryOutcomes":["Daily step count"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":["tezepelumab"],"locationSlugs":["leeds-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Tezepelumab for Severe Asthma","inPlainEnglish":"This study will see if a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases objectively measured physical activity and the proportion of adults with severe asthma achieving clinical remission compared with standard care alone. Although biologic therapies have improved asthma control for many people with severe asthma, many individuals remain physically inactive, experience reduced exercise tolerance, and continue to report symptoms that affect their quality of life.","whoItsFor":["Ages 18 Years to 70 Years","Adults aged 18-70 years","Physician-diagnosed severe asthma","Eligible for tezepelumab according to NICE TA880","History of ≥3 asthma exacerbations requiring oral corticosteroids in the previous 12 months or receiving maintenance oral corticosteroid therapy","Objective confirmation of asthma, including bronchodilator reversibility, bronchial hyperresponsiveness and/or variable airflow obstruction, as part of routine clinical assessment","Decision to commence tezepelumab made by the treating multidisciplinary severe asthma team prior to study enrolment"],"whoShouldSkip":["Non-asthma respiratory disease that may confound study outcomes (e.g. obstructive sleep apnoea)","Significant non-asthma medical conditions likely to impair physical activity or functional exercise capacity (e.g. acute musculoskeletal injury)","Any condition that, in the opinion of the investigator, would make participation unsafe or compromise study completion"],"whatHappens":"If you join, the listed intervention(s) are Physical activity promotion, or Tezepelumab. The registry lists allocation as randomized. This study will see if a structured physical activity promotion programme, delivered alongside standard treatment with tezepelumab, increases objectively measured physical activity and the proportion of adults with severe asthma achieving clinical remission compared with standard care alone.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 140 people at Leeds. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.870Z"},{"nctId":"NCT07735533","title":"A Phase 1/2 Study of UB-VV400 With Rapamycin in Relapsed/Refractory B-cell Malignancies","officialTitle":"A Phase 1/2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Umoja Biopharma","sponsorClass":"INDUSTRY","summary":"This study is a Phase 1/2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).","conditions":["Lymphoma, B Cell","Lymphoma Non-Hodgkin","High Grade B Cell Lymphoma","Richter Transformation Lymphoma","Grade 3b Follicular Lymphoma","Primary Mediastinal B Cell Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)"],"keywords":["CAR T","chimeric antigen receptor","CD22"],"interventions":[{"type":"GENETIC","name":"UB-VV400"},{"type":"DRUG","name":"Rapamycin (sirolimus)"}],"enrollment":274,"startDate":"2026-11","completionDate":"2031-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 18 years or older\n2. Provides voluntary written informed consent\n3. Relapsed or refractory large B-cell lymphoma (LBCL)\n4. Measurable disease according to Lugano 2014 criteria\n5. Confirmed CD22 expression\n6. No serious concomitant diseases or active/uncontrolled infections\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Adequate organ function\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding\n2. Current isolated central nervous system (CNS) involvement\n3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \\[TCR\\] fusion constructs, TCR T cells, and CAR T cells)\n4. History of or active human immunodeficiency virus (HIV)\n5. Active or chronic hepatitis B, or active hepatitis C\n6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease\n7. Ongoing CNS disease that would preclude neurologic assessment\n8. Uncontrolled angina or other acute heart disease\n9. Currently receiving treatment in another interventional clinical trial.","locations":[{"facility":"City of Hope","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luke Walker, MD","phone":"206-227-5056","email":"luke.walker@umoja-biopharma.com"},{"name":"Christine Dehner","phone":"","email":"christine.dehner@umoja-biopharma.com"}],"primaryOutcomes":["Phase 1: Percentage of participants with common adverse events (AEs)","Phase 2: Overall response rate (ORR)"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":["car-t"],"locationSlugs":["irvine-california","nashville-tennessee"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Rapamycin (sirolimus) for Lymphoma, B Cell","inPlainEnglish":"This study is a Phase 1/2 dose-finding and dose-confirmation study to measure the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed/refractory B-cell malignancies, including large B-cell lymphoma (LBCL).","whoItsFor":["Ages 18 Years to any","Relapsed or refractory large B-cell lymphoma (LBCL)","Measurable disease according to Lugano 2014 criteria","Confirmed CD22 expression","No serious concomitant diseases or active/uncontrolled infections","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Adequate organ function"],"whoShouldSkip":["Women who are pregnant or breastfeeding","Current isolated central nervous system (CNS) involvement","Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \\[TCR\\] fusion constructs, TCR T cells, and CAR T cells)","History of or active human immunodeficiency virus (HIV)","Active or chronic hepatitis B, or active hepatitis C","Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease","Ongoing CNS disease that would preclude neurologic assessment"],"whatHappens":"If you join, the listed intervention(s) are UB-VV400, or Rapamycin (sirolimus). The registry lists allocation as na. This study is a Phase 1/2 dose-finding and dose-confirmation study to measure the safety and antitumor activity of UB-VV400.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 274 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), genetic testing or a gene-targeted therapy plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.142Z"},{"nctId":"NCT07735715","title":"HOBSCOTCH-YOUTH and Young Adults","officialTitle":"HOBSCOTCH-YOUTH and Young Adults","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Dartmouth-Hitchcock Medical Center","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy. It will also learn if a modification of the program for youth with epilepsy, ages 13 - 17, improves thinking and memory and quality of life and reduces stress for their parents.\n\nResearchers will enroll 260 young adults with epilepsy and 40 youth with epilepsy and their parent or guardian. Researchers will compare responses to questionnaires and surveys before and after participation in the HOBSCOTCH program to see if thinking, memory and quality of life have improved for young adults and youth with epilepsy and to see if parents have improved quality of life as well.\n\nParticipants will:\n\n* Attend 9 weekly one-hour sessions of the HOBSCOTH program in their homes with a one-on-one coach using their computer or their phone; youth with epilepsy (ages 13 - 17) will attend alongside a parent or legal guardian.\n* Keep a short daily diary about their seizures and activity in the program using a smart phone app(lication)\n* Complete surveys and questionnaires before HOBSCOTCH and 3 months and 6 months later.\n\nThere are no study visits to a medical center. HOBSCOTCH is a virtual or telehealth intervention.","conditions":["Epilepsy","Cognitive Dysfunction, Cognitive Disorder","Memory and Thinking Problems"],"keywords":["Epilepsy","Seizures","Cognitive Dysfunction, Cognitive Disorder","Memory and thinking problems","Epilepsy Self-Management"],"interventions":[{"type":"OTHER","name":"HOBSCOTCH/HOBSCOTCH-YOUTH"}],"enrollment":300,"startDate":"2026-09-01","completionDate":"2029-05-01","sex":"ALL","minAge":"13 Years","maxAge":"29 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion Criteria for Young Adults with Epilepsy (YAWE) and Youth with Epilepsy (YWE):\n\n  * Age 18 - 29 years for YAWE\n  * Age 13 - 17 years for YWE\n  * For YWE at least one parent or legal guardian provides consent and agrees to participate\n  * Diagnosis of epilepsy (controlled or uncontrolled seizures)\n  * Subjective cognitive complaints (memory, attention, learning, problem solving, executive function, planning)\n  * Literate and proficient in English\n  * Telephone access\n  * Internet Access.\n\nInclusion Criteria for Parent of Youth with Epilepsy (YWE):\n\n* Parent or legal guardian of a youth with epilepsy (age 13 - 17 years)\n* Literate and proficient in English\n* Telephone access\n* Internet Access\n\nExclusion Criteria:\n\n* Active psychosis (any participant)\n* Illicit substance abuse (any participant)\n* Severe cognitive/intellectual disability (any participant)\n* YWE cannot participate without a parent and parent's consent (or legal guardian)\n* YWE cannot participate without assent even if a parent or legal guardian gives consent","locations":[{"facility":"Dartmouth-Hitchcock","city":"Lebanon","state":"New Hampshire","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wren M Kaden, BA","phone":"603-650-4225","email":"wren.m.kaden@hitchcock.org"},{"name":"Trina K Dawson, BA","phone":"603-650-4225","email":"trina.k.dawson@hitchcock.org"}],"primaryOutcomes":["Change in quality of life as measured by comparing QOLIE-31 scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)","Change in subjective cognition as measured by comparing NeuroQOL - Cognitive Function sub-scale scores at baseline to 3 months and 6 months post HOBSCOTCH intervention in young adults with epilepsy (YAWE)","Change in quality of life as measured by comparing QOLIE-AD-48 scores at baseline to 3 months and 6 months post- HOBSCOTCH-YOUTH intervention in youth with epilepsy (YWE)","Change in caregiver burden for parent/legal guardian of youth with epilepsy as measured by comparing Zarit Burden Interview scores at baseline to 3 months and 6 months post-HOBSCOTH-YOUTH intervention by their child"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["lebanon-new-hampshire"],"enrichment":{"headline":"Not a traditional drug phase: HOBSCOTCH/HOBSCOTCH-YOUTH for Epilepsy","inPlainEnglish":"The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy. It will also learn if a modification of the program for youth with epilepsy, ages 13 - 17, improves thinking and memory and quality of life and reduces stress for their parents.","whoItsFor":["Ages 13 Years to 29 Years","who can join for Young Adults with Epilepsy (YAWE) and Youth with Epilepsy (YWE):","Age 18 - 29 years for YAWE","Age 13 - 17 years for YWE","For YWE at least one parent or legal guardian provides consent and agrees to participate","Diagnosis of epilepsy (controlled or uncontrolled seizures)","Subjective cognitive complaints (memory, attention, learning, problem solving, executive function, planning)","Literate and proficient in English"],"whoShouldSkip":["Active psychosis (any participant)","Illicit substance abuse (any participant)","Severe cognitive/intellectual disability (any participant)","YWE cannot participate without a parent and parent's consent (or legal guardian)","YWE cannot participate without assent even if a parent or legal guardian gives consent"],"whatHappens":"If you join, the listed intervention(s) are HOBSCOTCH/HOBSCOTCH-YOUTH. The registry lists allocation as na. The goal of this clinical trial is to learn more about the home-based epilepsy self-management program, HOBSCOTCH, for improving cognitive function (thinking and memory) and quality of life specifically in young adults, ages 18 - 29 years, who have epilepsy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 300 people at Lebanon. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.908Z"},{"nctId":"NCT07735793","title":"A Real-world Study in Participants With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin Therapy in Korea","officialTitle":"A Real-world Study to Describe the Patient Journey, Treatment Patterns, and Outcomes of Patients With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmette-Guérin Therapy in Korea Using HIRA Claims Data","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen Korea, Ltd., Korea","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess participant's overall well-being and the extent to which medical services are used by participants with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have received Bacillus Calmette-Guérin (BCG) therapy. HR-NMIBC is a type of bladder cancer in which cancer is confined to the inner lining of the bladder and has a high risk of returning or becoming more serious. BCG therapy is a treatment administered directly into the bladder to help prevent the cancer from returning or progressing.","conditions":["Urinary Bladder Neoplasms"],"keywords":[],"interventions":[],"enrollment":1,"startDate":"2026-10-12","completionDate":"2026-11-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of bladder cancer (BC) based on International Classification of Diseases, 10th Revision (ICD-10) codes (C67 or D090) and cancer-specific insurance code V193 within the patient identification period of September 1, 2015, to August 31, 2024.\n* Two outpatient or one inpatient visit anytime during the study period for bladder cancer.\n* Received intravesical Bacillus Calmette-Guérin (BCG) following the qualifying transurethral resection of bladder tumor (TURBT). The date of first BCG instillation serves as the index date.\n* No evidence of bladder cancer diagnosis, intravesical chemotherapy, or BCG in the 5-year look-back period prior to the qualifying TURBT, to ensure an incident BC definition.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease based on confirmed diagnosis (ICD-10: C77-C80) on or before index TURBT, or within 30 days after the index TURBT.\n* Evidence of confirmed cancer diagnosis other than bladder cancer (ICD-10: C00-C76, C81-C97, excluding C67) on or before the index TURBT.\n* Evidence of systemic treatments or radical cystectomy within 30 days after index TURBT.\n* Less than 12 months of potential follow-up to the data cutoff after the index date (including patients with a claims-inactivity-based death proxy within 12 months from the index date).","locations":[{"facility":"Sungkyunkwan University Research and Business Foundation","city":"Suwon","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants Receiving Bacillus Calmette-Guérin (BCG) Induction and Maintenance Therapy","Number of Participants Reporting BCG Treatment Completion","Time Between Successive BCG Instillations","Number of Intravesical Chemotherapy Instillations","Duration of Intravesical Chemotherapy","Frequency of Intravesical Chemotherapy Instillations","Time Between Successive Intravesical Chemotherapy Instillations","Number of Participants Requiring BCG Re-treatment","Number of Participants Requiring Intravesical Chemotherapy","Time to Next Treatment","Time to Cystectomy","Radical Cystectomy Incidence","Metastasis-Free Survival","Overall Survival"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["suwon-south-korea"],"enrichment":{"headline":"A Real-world Study in Participants With High-risk Non-Muscle-Invasive Bladder Cancer After Bacillus Calmett…","inPlainEnglish":"This study wants to assess participant's overall well-being and the extent to which medical services are used by participants with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) who have received Bacillus Calmette-Guérin (BCG) therapy. HR-NMIBC is a type of bladder cancer in which cancer is confined to the inner lining of the bladder and has a high risk of returning or becoming more serious.","whoItsFor":["Ages 18 Years to any","Confirmed diagnosis of bladder cancer (BC) based on International Classification of Diseases, 10th Revision (ICD-10) codes (C67 or D090) and cancer-specific insurance code V193 within the patient identification period of September 1, 2015, to August 31, 2024","Two outpatient or one inpatient visit anytime during the study period for bladder cancer","Received intravesical Bacillus Calmette-Guérin (BCG) following the qualifying transurethral resection of bladder tumor (TURBT). The date of first BCG instillation serves as the index date","No evidence of bladder cancer diagnosis, intravesical chemotherapy, or BCG in the 5-year look-back period prior to the qualifying TURBT, to ensure an incident BC definition"],"whoShouldSkip":["Evidence of metastatic disease based on confirmed diagnosis (ICD-10: C77-C80) on or before index TURBT, or within 30 days after the index TURBT","Evidence of confirmed cancer diagnosis other than bladder cancer (ICD-10: C00-C76, C81-C97, excluding C67) on or before the index TURBT","Evidence of systemic treatments or radical cystectomy within 30 days after index TURBT","Less than 12 months of potential follow-up to the data cutoff after the index date (including patients with a claims-inactivity-based death proxy within 12 months from the index date)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1 people at Suwon. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.290Z"},{"nctId":"NCT07736586","title":"A Study of HL40626S Tablets in Healthy Adults","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, 2-Part, Phase Ι Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HL40626S Tablets Following Oral Administration of Single and Multiple Ascending Doses to Healthy Adult Participants.","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"HighsLab Therapeutics Inc.","sponsorClass":"INDUSTRY","summary":"This is a single-centre, randomized, double-blind, placebo-controlled Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.","conditions":["Skin Disease","Immune System Disease","Skin Diseases, Papulosquamous","Psoriasis (PsO)"],"keywords":["Phase 1","Healthy Participants","HL40626S","Oral Tablets","SAD","MAD","Safety","Pharmacokinetics","Immunogenicity","Pharmacodynamics","IL-23R"],"interventions":[{"type":"DRUG","name":"HL40626S tablets"},{"type":"DRUG","name":"HL40626S placebo"}],"enrollment":64,"startDate":"2026-08-05","completionDate":"2027-02","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Capable of understanding the written informed consent document; willingly provides valid, signed written informed consent; willing and able to comply with the schedule, requirements and restrictions of the study.\n2. Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening.\n3. BMI between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg.\n4. In good general health, as determined by the Investigator.\n5. Female participants must be non-pregnant and non-lactating.\n6. Female participants must be of non-childbearing potential, or agree to use dual contraception methods (female participants exclusively in same-sex relationships are exempt from the above contraception requirements), and abstain from ova (egg) donation throughout the entire duration of the study and for at least 90 days after the last dose, and have negative pregnancy test results at Screening (serum) and Day -1 (urine). (Note: As this is a first-in-human \\[FIH\\] study, the applicable t₁/₂ and corresponding restriction period may be adjusted based on emerging PK data).\n7. Male participants with female partners of reproductive potential must agree to practice complete abstinence or to use a condom (male participant) plus an additional highly effective method (female partner) of contraception for the duration of the study and for at least 90 days after last dosing (Male participants exclusively in same-sex relationships are exempt from the above contraception requirements); all male participants must also agree to refrain from sperm donation for at least 90 days after the last dose. (Note: As this is a FIH study, the applicable t₁/₂ and corresponding restriction period will be adjusted based on real-time PK data).\n\nExclusion Criteria:\n\n1. Clinically significant abnormal medical history, such as gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, drug hypersensitivity, as determined by the Investigator, any abnormal findings on physical examination, VS measurements, ECG or laboratory tests at Screening, Admission or pre dose on Day 1 that, in the opinion of the Investigator, could jeopardize achieving the study objectives and/or compromise the participant's safety.\n2. Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:\n\n   1. Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator.\n   2. Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and/or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities).\n   3. Participants with QTcF \\>450 msec (if male) or \\>470 msec (if female) will be excluded.\n3. Resting HR \\< 40 bpm or \\>100 bpm when vital signs are measured at Screening\n4. SARS-CoV-2 positive by PCR at Admission regardless of symptoms.\n5. Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia.\n6. Ongoing liver disease or unexplained liver function test (LFT) elevations, defined as ALT, AST, gamma glutamyltransferase (GGT), alkaline phosphatase (ALP) or total/direct bilirubin \\> upper limit of the reference range (ULRR) at Screening or Admission. Participants with confirmed Gilbert's syndrome will not be permitted to enroll in the study.\n7. Indications of pre-metabolic syndrome and/or systemic inflammation, as suggested by high-sensitivity C-reactive protein (hsCRP) of \\> 3 mg/L, elevated erythrocyte sedimentation rate (Male ≥ 15 mm/hr, Female ≥ 20 mm/hr) or Hemoglobin A1c (HbA1c) \\>5.3% at Screening.\n8. History of cancer (malignancy) with the exception of basal or squamous cell carcinoma of the skin.\n9. Respiratory tract infection (upper and/or lower) treated with antibiotics within 12 weeks of Screening.\n10. Clinically significant infection or known inflammatory condition or history of clinically significant infection within 28 days prior to study drug administration on Day 1 that, in the opinion of the Investigator, would affect the participant's ability to participate in the trial.\n11. History of drug or alcohol abuse (as defined by DSM-V) within 12 months prior to Screening.\n12. Positive test result for alcohol (breath) or drugs of abuse (urine) at Screening or Admission.\n13. Positive serology result for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus antibody (HIV Ab) at Screening.\n14. Active or recent herpes simplex or herpes zoster infection, if considered clinically relevant as per investigator discretion.\n15. Venous access considered inadequate for PK sample collection; history of evidence of adverse symptoms associated with phlebotomy or blood donation.\n16. Participation in a study of any investigational drug, device, biologic or other agent within 30 days (or 5 half-lives, whichever is longer \\[as applicable\\]) prior to Day 1.\n17. Loss or donation of blood \\>500 mL (within 30 days prior to Screening); donation of bone marrow or peripheral stem cells (within 90 days prior to Day 1); or donation of plasma (within 7 days prior to Screening).\n18. No more than 10 standard drinks per week per NHMRC alcohol guidelines within 90 days prior to screening.\n19. Use of alcohol within 72 hours prior to study drug administration on Day 1.\n20. Use of prescription drugs within 14 days (or 5 half-lives, whichever is longer), or non-prescription drugs and/or herbal supplements within 7 days (or 5 half-lives, whichever is longer) prior to study drug administration on Day 1. Exception: hormonal contraceptives, acetaminophen ≤ 1 gram/day or ibuprofen ≤ 800 mg/day may be administered at Investigator's discretion.","locations":[{"facility":"Nucleus Network","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nucleus Network Pty Ltd","city":"Melbourne","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arockiaa P Aarthy Joseph, MBBS","phone":"61-459 361 568","email":"a.joseph@nucleusnetwork.com.au"}],"primaryOutcomes":["Parts 1 (SAD) and 2 (MAD): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","Parts 1 (SAD) and 2 (MAD): Incidence of serious adverse events (SAEs) [Safety and Tolerability]","Parts 1 (SAD) and 2 (MAD): Proportion of participants with clinically significant abnormal findings in physical examinations, vital signs, clinical laboratory tests, and 12-lead ECG assessments relative to baseline [Safety and Tolerability]"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["melbourne-australia"],"enrichment":{"headline":"Phase 1: testing HL40626S tablets for Skin Disease","inPlainEnglish":"This is a single-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.","whoItsFor":["Ages 18 Years to 55 Years","Between the ages of 18.0 and 55.0 years (inclusive) at the time of Screening","body-mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive) at the time of Screening, with a body weight ≥ 50 kg","In good general health, as determined by the Investigator","Female participants must be non-pregnant and non-lactating"],"whoShouldSkip":["Any of the following ECG findings at Screening, Admission and/or pre dose on Day 1:","Any out-of-range ECG parameter(s) or abnormal finding(s) considered clinically significant by the Investigator","Any ECG finding that, in the opinion of the Investigator, may compromise interpretation of ECG for cardiac safety assessments and/or complicate interpretation of events that may occur post dose (e.g., QT not accurately measurable, conduction abnormalities)","Participants with QTcF \\>450 msec (if male) or \\>470 msec (if female) will be excluded","Resting HR \\< 40 bpm or \\>100 bpm when vital signs are measured at Screening","SARS-CoV-2 positive by PCR at Admission regardless of symptoms","Unstable cardiovascular disease, including recent (within 6 months of screening) myocardial infarction or cardiac arrhythmia"],"whatHappens":"If you join, the listed intervention(s) are HL40626S tablets, or HL40626S placebo. The registry lists allocation as randomized. This is a single-centre, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment Phase 1 study to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HL40626S tablets following single and multiple ascending oral doses to healthy adult participants aged 18-55 years.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 64 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.579Z"},{"nctId":"NCT07737743","title":"A Phase 2a/b Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Sjögren's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"To evaluate efficacy, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.","conditions":["Sjögren's Disease"],"keywords":["Sjögren's Disease","ESSDAI","ESSPRI"],"interventions":[{"type":"DRUG","name":"DDY391"},{"type":"DRUG","name":"Placebo"}],"enrollment":344,"startDate":"2026-08-24","completionDate":"2029-02-19","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n• Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening:\n\n\\- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD.\n\nKey Exclusion Criteria:\n\n* Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness.\n* Exclusion based on medications being used for SjD:\n\n  * Participants taking \\> 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.\n  * Participants taking \\> 400 mg/day hydroxychloroquine are excluded. Participants on ≤ 400 mg/day of hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization.\n* Prior treatment with any of the following within 3 months prior to randomization: belimumab, abatacept, anti-tumor necrosis factor alpha biologic agents, immunoglobulins, plasmapheresis, intravenous (i.v.) or oral cyclophosphamide, mycophenolate mofetil, i.v. or oral cyclosporine A, or any other immunosuppressants (e.g., JAK inhibitors or other kinase inhibitors, IL-2, anti-IL-6, anti-IL-17).\n* Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening.\n* Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection.\n* History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Arizona Arthritis and Rheumatology Associates PLLC","city":"Avondale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Res Of W Florida","city":"Clearwater","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida Inc","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Clinical Research Inst","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Willow Rheumatology Wellness","city":"Willowbrook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"RAO Research LLC","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altoona Center for Clin Res","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rheumatology Specialty Center - Willow Grove Office","city":"Willow Grove","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shelby Research LLC","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stryde Research-Allen Arthritis","city":"Allen","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novel Research LLC","city":"Bellaire","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Care of Texas","city":"Corpus Christi","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Southport","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nedlands","state":"Western Australia","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Rimouski","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Sherbrooke","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Trois-Rivières","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Taiyuan","state":"Shanxi","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Bogota","state":"Cundinamarca","country":"Colombia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kaposvár","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Kfar Saba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Ramat Gan","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Tsrifin","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Novartis Investigative Site","city":"Groningen","state":"Provincie Groningen","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Part A and B: Change from baseline in ESSDAI score","Part C: Change from baseline in ESSPRI"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["avondale-arizona","clearwater-florida","tampa-florida","chicago-illinois","willowbrook-illinois","oklahoma-city-oklahoma","duncansville-pennsylvania","willow-grove-pennsylvania","memphis-tennessee","allen-texas","bellaire-texas","corpus-christi-texas","southport-australia","nedlands-australia","rimouski-canada","sherbrooke-canada","trois-rivi-res-canada","hefei-china","nanjing-china","taiyuan-china","beijing-china","bogota-colombia","paris-france","kaposv-r-hungary","kfar-saba-israel","petah-tikva-israel","ramat-gan-israel","tel-aviv-israel","tsrifin-israel","groningen-netherlands"],"enrichment":{"headline":"Phase 2: testing DDY391 for Sjögren's Disease","inPlainEnglish":"To evaluate how well it works, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.","whoItsFor":["Ages 18 Years to 100 Years","Participants must have a diagnosis of SjD according to the ACR/EULAR 2016 classification criteria at screening:","\\- Positive anti-Ro (SSA) antibodies at screening. Participants negative for anti-Ro/SSA antibodies are eligible if they have documented previous biopsy showing evidence of salivary gland inflammation consistent with SjD"],"whoShouldSkip":["Presence of another autoimmune rheumatic disease that is active at screening and constitutes the principal illness","Exclusion based on medications being used for SjD:","Participants taking \\> 400 mg/day hydroxychloroquine are excluded. Participants taking ≤400 mg/day hydroxychloroquine should be on a stable dose for at least 4 weeks prior to randomization","Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to screening","Any viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infection","History of malignancy of any organ system (other than localized non melanoma carcinoma of the skin or in situ cervical cancer) within the last five years of randomization or any malignancy not in remission","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are DDY391, or Placebo. The registry lists allocation as randomized. To evaluate how well it works, safety, and tolerability of DDY391 up to 52 weeks in participants with Sjögren's disease (SjD) and to determine the dose response relationship of DDY391 in participants with SjD, to support dose selection for Phase 3.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 344 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.950Z"},{"nctId":"NCT07737899","title":"Primary Palliative Care - a Feasibility Cluster Trial","officialTitle":"Primary Palliative Care - a Feasibility Cluster Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Coimbra","sponsorClass":"OTHER","summary":"This feasibility cluster-controlled randomized trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness. One FHU will receive the intervention and one FHU will follow usual care. The primary goal is to assess feasibility metrics (GP adherence, patient recruitment rate, and patient retention rate), which will inform the design of a subsequent full-scale cluster RCT.","conditions":["Palliative Care","Primary Palliative Care","Advanced Cancer","Chronic Obstructive Pulmonary Disease (COPD)","Congestive Heart Failure Chronic","Chronic Kidney Disease (Stages 4 and 5)"],"keywords":["Palliative care","Primary Palliative Care","General practice","Family medicine","Feasibility study","Cluster randomized controlled trial","Complex intervention","Chronic disease"],"interventions":[{"type":"OTHER","name":"Primary Palliative Care Complex Intervention (PrimPal)"}],"enrollment":30,"startDate":"2026-10-01","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18 years or older.\n* Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units.\n* Diagnosed with one or more of the following advanced chronic conditions:\n* Advanced-stage neoplasm (metastatic/stage IV cancer);\n* Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;\n* Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;\n* Chronic Kidney Disease (CKD) - stage IV or V.\n\nExclusion Criteria:\n\n* Refusal to provide informed consent or to participate in the study at any point.\n* Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment).","locations":[{"facility":"Family Health Unit 1 - ULS Coimbra (Intervention)","city":"Coimbra","state":"","country":"Portugal","status":"RECRUITING","lat":null,"lon":null},{"facility":"Family Health Unit 2 - ULS Coimbra (Control)","city":"Coimbra","state":"","country":"Portugal","status":"ENROLLING_BY_INVITATION","lat":null,"lon":null}],"contacts":[{"name":"Carlos S Cardoso, PhD","phone":"00351 239 857 700","email":"carlosseicacardoso@uc.pt"}],"primaryOutcomes":["GP Feasibility Rate (Implementation Rate)"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","heart-failure","copd"],"drugSlugs":[],"locationSlugs":["coimbra-portugal"],"enrichment":{"headline":"Not a traditional drug phase: Primary Palliative Care Complex Intervention (PrimPal) for Palliative Care","inPlainEnglish":"This feasibility cluster-controlled randomly assigned trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs). The intervention consists of training General Practitioners (GPs) in palliative care through a 30 hour e-learning program and implementing a structured consultation model (4 consultations over 12 weeks) for adult patients with advanced chronic illness.","whoItsFor":["Ages 18 Years to any","Aged 18 years or older","Enrolled as a patient on the list of a recruited General Practitioner in one of the participating Family Health Units","Diagnosed with one or more of the following advanced chronic conditions:","Advanced-stage neoplasm (metastatic/stage IV cancer);","Chronic Obstructive Pulmonary Disease (COPD) - GOLD classification III or IV;","Congestive Heart Failure (CHF) - New York Heart Association (NYHA) functional classification III or IV;","Chronic Kidney Disease (CKD) - stage IV or V"],"whoShouldSkip":["Disease severity requiring urgent medical intervention (acute crisis/emergency care need at time of recruitment)"],"whatHappens":"If you join, the listed intervention(s) are Primary Palliative Care Complex Intervention (PrimPal). The registry lists allocation as randomized. This feasibility cluster-controlled randomly assigned trial (RCT) evaluates a complex intervention for the delivery of primary palliative care in Family Health Units (FHUs).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.489Z"},{"nctId":"NCT07738978","title":"Understanding and Enhancing Human Health and Movement","officialTitle":"Understanding and Enhancing Human Health and Movement","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Louis Stokes VA Medical Center","sponsorClass":"FED","summary":"By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.","conditions":["Spinal Cord Injury","Stroke (CVA) or Transient Ischemic Attack","Multiple Sclerosis"],"keywords":["paralysis","electrical stimulation","neuroprosthesis","implanted device"],"interventions":[{"type":"DEVICE","name":"Neural Prosthesis"}],"enrollment":75,"startDate":"2021-03-21","completionDate":"2031-03-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Skeletal maturity and ability to sign informed consent (\\>18 years)\n* Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs\n* Innervated and excitable lower extremity and trunk musculature\n* Adequate social support and stability\n* Willingness to comply with follow-up procedures\n* Time post injury greater than six months\n* Appropriate body habitus (height and weight within acceptable limits as determined by study physician)\n* Neurologically stable as determined by a physician\n\nExclusion Criteria:\n\n* Non-English speaking\n* Females who are pregnant\n* Current pressure injuries that would be exacerbated by study activities\n* Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities\n* History of spontaneous fractures or other evidence of excessively low bone density\n* History of vestibular dysfunction, balance problems, or spontaneous falls\n* Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.\n* Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension\n* Presence of a demand pacemaker or cardiac defibrillator\n* Any other medical or psychological condition that would be a contraindication\n* Current pressure ulcers\n* Significant range of motion limitations that would compromise study activities\n* Body habitus that would compromise study activities","locations":[{"facility":"Louis Stokes Cleveland VA Medical Center","city":"Cleveland","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maura Malenchek, PTA","phone":"216-791-3800","email":"maura.malenchek@va.gov"},{"name":"Lisa Lombardo, MPT","phone":"2167913800","email":"lisa.lombardo2@va.gov"}],"primaryOutcomes":["Max Standing Time","Percent body weight","Walking Distance","Walking Time","Modified functional reach"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","stroke"],"drugSlugs":[],"locationSlugs":["cleveland-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Neural Prosthesis for Spinal Cord Injury","inPlainEnglish":"By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.","whoItsFor":["Ages 18 Years to any","Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs","Innervated and excitable lower extremity and trunk musculature","Adequate social support and stability","Willingness to comply with follow-up procedures","Time post injury greater than six months","Appropriate body habitus (height and weight within acceptable limits as determined by study physician)","Neurologically stable as determined by a physician"],"whoShouldSkip":["Non-English speaking","Females who are pregnant","Current pressure injuries that would be exacerbated by study activities","Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities","History of spontaneous fractures or other evidence of excessively low bone density","History of vestibular dysfunction, balance problems, or spontaneous falls","Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture"],"whatHappens":"If you join, the listed intervention(s) are Neural Prosthesis. The registry lists allocation as na. By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 75 people at Cleveland. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.977Z"},{"nctId":"NCT07739966","title":"A Study of DS-3939a in Participants With Solid Tumors","officialTitle":"A Phase 1b/2, Multicenter, 2-part, Open-label Trial to Evaluate DS-3939a in Participants With Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Daiichi Sankyo","sponsorClass":"INDUSTRY","summary":"The primary purpose of the study is to evaluate the safety, tolerability, and efficacy of DS-3939a in combination with other anticancer agents or as a monotherapy in participants with solid tumors.","conditions":["Solid Tumor","Locally Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"DS-3939a"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Pemetrexed"},{"type":"DRUG","name":"DS-1103a"}],"enrollment":400,"startDate":"2026-10-13","completionDate":"2030-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures.\n2. Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old).\n3. Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC.\n4. Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions.\n6. Has adequate organ function.\n7. Participants must have measurable disease by investigator assessment according to RECIST v1.1.\n\nAdditional Inclusion Criteria for Substudy 1:\n\n1\\. Participants must not have received prior systemic therapy for locally advanced unresectable or metastatic NSCLC.\n\nAdditional Inclusion Criteria for Substudy 2:\n\n1. Participants with AGA (excluding EGFR mutation): Participants have been previously treated with targeted therapy for the AGA and platinum-based chemotherapy for the advanced disease setting.\n2. Participants without AGA: Participants have been previously treated with platinum-based chemotherapy and anti-programmed death-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibody\n3. Part 2 only: Participants must have received only 1 or 2 prior lines of anticancer therapy for the advanced disease setting.\n\nExclusion Criteria:\n\n1. Prior systemic anticancer therapy targeting MUC1 or TA-MUC1.\n2. Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan).\n3. Has spinal cord compression or clinically active central nervous system (CNS) metastases.\n4. Has multiple primary malignancies.\n5. Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening\n6. Has active or uncontrolled human immunodeficiency virus (HIV) infection.\n7. Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection.\n8. Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.\n9. Current participation in other therapeutic investigational procedures, except for participation in long term survival follow-up (LTSFU) without any investigational treatment.","locations":[{"facility":"Highlands Oncology Group (Hog) - Fayetteville","city":"Fayetteville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UCLA Health","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center - Magnolia Campus","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lifespan Cancer Institute - Rhode Island Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas Md Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inova Schar Cancer Institute","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto Alexander Fleming","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Oncologico de Cordoba (Ionc) - Fundacion Richardet Longo","city":"Córdoba","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sanatorio Parque","city":"Rosario","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cer San Juan - Centro Polivalente de Asistencia E Investigacion Clinica","city":"San Juan","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinica Viedma S.A.","city":"Viedma","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Universitat Innsbruck","city":"Innsbruck","state":"","country":"Austria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Karl Landsteiner Institut Fur Lungenforschung Und Pneumologische Onkologie","city":"Vienna","state":"","country":"Austria","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universite Libre de Bruxelles (Ulb) - Institut Jules","city":"Brussels","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jessa Ziekenhuis - Hartcentrum Hasselt","city":"Sint-Truiden","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundacao Pio Xii-Hospital de Cancer de Barretos","city":"Barretos","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Liga Norte Riograndense Contra O Cancer - Pesquisa Clinica","city":"Natal","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Irmandade Da Santa Casa de Misericordia de Porto Alegre","city":"Porto Alegre","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Sao Lucas Da Pucrs","city":"Porto Alegre","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Obras Sociais Irma Dulce - Centro de Pesquisa Oncologica E Clinica (Cpoc)","city":"Salvador","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Israelita Albert Einstein","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Chest Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jilin Cancer Hospital","city":"Changchun","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hunan Cancer Hospital","city":"Changsha","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Sun Yat-Sen University","city":"Guangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Zhejiang University School of Medicine (Zhejiang Provincial First Hos","city":"Hangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital","city":"Hangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Harbin Medical University Cancer Hospital","city":"Harbin","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University Cancer Institute and Hospital","city":"Hexi District, Tianjin","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jiamusi Cancer Hospital","city":"Jiamusi","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shandong University - Shandong Cancer Hospital","city":"Jinan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lin Yi Cancer Hospital","city":"Linyi","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai East Hospital","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province","city":"Taizhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hubei Cancer Hospital","city":"Wuhan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Henan Provincial Cancer Hospital","city":"Zhengzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aphm - Hopital Nord","city":"Marseille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire de Montpellier (Chu Montpellier) - Hopital Lapeyronie","city":"Montpellier","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospitalier Paris Saint-Joseph","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Universitaire (Chu) de Rennes - Hopital de Pontchaillou","city":"Rennes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut de Cancerologie de L'Ouest (Ico) - Saint-Herblain","city":"Saint-Herblain","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Foch","city":"Suresnes","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Unicancer-Institut de Cancerologie de Lorraine (Icl)","city":"Vandœuvre-lès-Nancy","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituto Europeo Di Oncologia","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero - Universitaria San Luigi Gonzaga","city":"Orbassano","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universita Degli Studi Di Pavia-Fondazione Irccs Policlinico San Matteo","city":"Pavia","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Di Perugia - Ospedale Santa Maria Della Misericordia","city":"Perugia","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Servizio Sanitario Regionale Emilia-Romagna - Azienda Unita Sanitaria Locale Della Romagna - Ospedal","city":"Ravenna","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Hirakata","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cancer Center Hospital East","city":"Kashiwa-shi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization (Nho) Shikoku Cancer Center","city":"Matsuyama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sendai Kousei Hospital","city":"Sendai","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Hokkaido Cancer Center","city":"Shiroishi-ku, Sapporo-shi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Del Mar","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Arnau de Vilanova (Lleida)","city":"Lleida","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital General Universitario Gregorio Maranon","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico San Carlos","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen de La Victoria","city":"Málaga","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico Universitario de Santiago","city":"Santiago de Compostela","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Macarena","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio (Huvr)","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taichung Veterans General Hospital","city":"Taichung","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital Nckuh","city":"Tainan","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taipei Veterans General Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ankara Bilkent Sehir Hastanesi (Ankara City Hospital)","city":"Ankara","state":"","country":"Tunisia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Ankara Hospital","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Liv Hospital Ankara","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"T.C. Saglik Bakanligi Ankara Ataturk Egitim Ve Arastirma Hastanesi (Ankara Ataturk Training and Rese","city":"Ankara","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ege Universitesi Tip Fakultesi Hastanesi","city":"Bornova","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Adana City Training & Research Hospital","city":"Yüreğir","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daiichi Sankyo Contact for Clinical Trial Information","phone":"9089926400","email":"CTRinfo_us@daiichisankyo.com"}],"primaryOutcomes":["Part 1: Number of Participants With Dose-limiting Toxicities (DLTs)","Part 1: Number of Participants With TEAEs","Part 2: Objective Response (OR) Per RECIST v1.1 as Assessed by Investigator"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["fayetteville-arkansas","los-angeles-california","tampa-florida","portland-oregon","providence-rhode-island","houston-texas","fairfax-virginia","buenos-aires-argentina","c-rdoba-argentina","rosario-argentina","san-juan-argentina","viedma-argentina","innsbruck-austria","vienna-austria","brussels-belgium","sint-truiden-belgium","barretos-brazil","natal-brazil","porto-alegre-brazil","salvador-brazil","s-o-paulo-brazil","beijing-china","changchun-china","changsha-china","guangzhou-china","hangzhou-china","harbin-china","hexi-district-tianjin-china","jiamusi-china","jinan-china","linyi-china","shanghai-china","taizhou-china","wuhan-china","zhengzhou-china","marseille-france","montpellier-france","paris-france","rennes-france","saint-herblain-france","suresnes-france","vand-uvre-l-s-nancy-france","villejuif-france","milan-italy","orbassano-italy","pavia-italy","perugia-italy","ravenna-italy","rome-italy","hirakata-japan","kashiwa-shi-japan","matsuyama-japan","sendai-japan","shiroishi-ku-sapporo-shi-japan","barcelona-spain","lleida-spain","madrid-spain","m-laga-spain","santiago-de-compostela-spain","seville-spain","taichung-taiwan","tainan-taiwan","taipei-taiwan","ankara-tunisia","ankara-turkey-t-rkiye","bornova-turkey-t-rkiye","istanbul-turkey-t-rkiye","y-re-ir-turkey-t-rkiye"],"enrichment":{"headline":"Phase 1 / Phase 2: testing DS-3939a for Solid Tumor","inPlainEnglish":"The primary purpose of the study is to measure the safety, tolerability, and how well it works of DS-3939a in combination with other anticancer agents or as a this drug alone in participants with solid tumors.","whoItsFor":["Ages 18 Years to any","Adults greater than or equal to (≥)18 years of age at the time the Main Trial ICF is signed (follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old)","Histologically documented Stage IIIB, IIIC disease who is not candidate for surgical resection or definitive chemoradiation, or Stage IV NSQ NSCLC","Has a left ventricular ejection fraction (LVEF) ≥50 percent (%) by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days of the first trial intervention","Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 assessed no more than 14 days prior to initiation of trial interventions","Has adequate organ function","Participants must have measurable disease by investigator assessment according to RECIST v1.1","Additional who can join for Substudy 1:"],"whoShouldSkip":["Prior systemic anticancer therapy targeting MUC1 or TA-MUC1","Prior systemic anticancer therapy with topoisomerase 1 inhibitor or topoisomerase 1 inhibitor-based antibody-drug conjugate (ADCs) (e.g., datopotamab deruxtexan and Sacituzumab govitecan)","Has spinal cord compression or clinically active central nervous system (CNS) metastases","Has multiple primary malignancies","Has any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at screening","Has active or uncontrolled human immunodeficiency virus (HIV) infection","Has active or uncontrolled hepatitis B virus (HBV)/hepatitis C virus (HCV) infection"],"whatHappens":"If you join, the listed intervention(s) are DS-3939a, Pembrolizumab, or Carboplatin. The registry lists allocation as randomized. The primary purpose of the study is to measure the safety, tolerability, and how well it works of DS-3939a in combination with other anticancer agents or as a this drug alone in participants with solid tumors.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 400 people at 76 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.713Z"},{"nctId":"NCT07741396","title":"BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation","officialTitle":"BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation as a Model for Chronic Disease Management","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Illinois Chicago","sponsorClass":"OTHER","summary":"The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes.\n\nCardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes. Although cardiac rehabilitation is highly recommended and beneficial, many patients do not receive the full benefits of the program. Some patients attend fewer sessions than recommended, and many find it difficult to maintain healthy habits outside of the clinic, such as regular physical activity, heart-healthy eating, taking medications as prescribed, monitoring blood pressure, and managing weight.\n\nThis study will test whether combining CBCR with mobile health tools may improve participation and support healthy behaviors at home. Mobile health tools include mobile phone applications, connected devices such as a weight scale, blood pressure monitor, and activity tracker, as well as personalized text messages designed to encourage and support healthy self-care.\n\nThis study will help determine whether these mobile health tools can make cardiac rehabilitation more effective and help patients maintain healthy behaviors beyond the clinic setting.","conditions":["Acute Myocardial Infarction (AMI)","Percutaneous Coronary Intervention (PCI)","Coronary Artery Bypass Graft Surgery (CABG)","Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Valve Repair or Replacement","Stable Angina Pectoris"],"keywords":["cardiac rehabilitation","mHealth","digital tool","consumer-grade technology"],"interventions":[{"type":"OTHER","name":"CBCR"},{"type":"BEHAVIORAL","name":"BRIDGE mHealth intervention"}],"enrollment":30,"startDate":"2026-11-02","completionDate":"2027-03-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 18 years or older.\n2. Enrolled in or referred to Phase II Center-based Cardiac Rehabilitation Program.\n3. Have a qualifying cardiovascular diagnosis or event that meets standard eligibility for Phase II Center-based Cardiac Rehabilitation, such as:\n\n   * Acute myocardial infarction\n   * Percutaneous coronary intervention\n   * Coronary artery bypass graft surgery\n   * Chronic heart failure with reduced ejection fraction\n   * Heart valve repair or replacement\n   * Stable angina\n4. Able to ambulate and participate in exercise testing and training as required by the CR program\n5. Ability to speak and read in English\n6. Willing and able to provide informed consent.\n7. Willing to use study-related devices/apps and complete study assessments.\n\nExclusion Criteria:\n\n1. Not enrolled in or not planning to participate in Phase II Center-based Cardiac Rehabilitation Program.\n2. Presence of a medical, cognitive, psychiatric, or physical condition that, in the opinion of the investigators or CR team, would preclude safe participation in the study or adherence to study procedures.\n3. Severe cognitive impairment or active psychiatric illness that would interfere with informed consent or study participation.\n4. Terminal illness or other serious medical condition that in the judgement of the treating clinician or investigator would likely preclude completion of the study follow-up period. .\n5. Current hospice enrollment or residence in a long-term care facility that would preclude participation in the intervention or completion of study follow-up procedures.\n6. Currently participating in another behavioral or digital health intervention trial that could confound study outcomes.\n7. Inability or unwillingness to use the required mobile devices, applications, or monitoring equipment, if applicable.","locations":[{"facility":"University of Illinois Hospital and Health Sciences System","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Leah Li, MSN, RN","phone":"13123553519","email":"yli351@uic.edu"}],"primaryOutcomes":["Functional capacity as measured by peak metabolic equivalents (METs)."],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: CBCR for Acute Myocardial Infarction (AMI)","inPlainEnglish":"The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes. Cardiac rehabilitation is an evidence-based outpatient program designed to help people recover from heart-related conditions through supervised exercise, education, counseling, and support for healthy lifestyle changes.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Enrolled in or referred to Phase II Center-based Cardiac Rehabilitation Program","Have a qualifying cardiovascular diagnosis or event that meets standard eligibility for Phase II Center-based Cardiac Rehabilitation, such as:","Acute myocardial infarction","Percutaneous coronary intervention","Coronary artery bypass graft surgery","Chronic heart failure with reduced ejection fraction"],"whoShouldSkip":["Not enrolled in or not planning to participate in Phase II Center-based Cardiac Rehabilitation Program","Presence of a medical, cognitive, psychiatric, or physical condition that, in the opinion of the investigators or CR team, would preclude safe participation in the study or adherence to study procedures","Terminal illness or other serious medical condition that in the judgement of the treating clinician or investigator would likely preclude completion of the study follow-up period.","Current hospice enrollment or residence in a long-term care facility that would preclude participation in the intervention or completion of study follow-up procedures","Currently participating in another behavioral or digital health intervention trial that could confound study outcomes","Inability or unwillingness to use the required mobile devices, applications, or monitoring equipment, if applicable"],"whatHappens":"If you join, the listed intervention(s) are CBCR, or BRIDGE mHealth intervention. The registry lists allocation as randomized. The purpose of the BRIDGE study is to learn whether supplementing traditional center-based cardiac rehabilitation (CBCR) with a mobile health technology intervention can help patients monitor their health, stay engaged in healthy lifestyle behaviors, better manage cardiovascular risk factors, and improve overall health outcomes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.426Z"},{"nctId":"NCT07743164","title":"A Clinical Trial of Raludotatug Deruxtecan (R-DXd) With or Without Bevacizumab in Participants With Ovarian Cancer Who Have Progressed During Treatment With PARP-inhibitors Treatment on First Line Maintenance (MK-5909-008/ENGOT-ov107/GOG-3142 / REJOICE-Ovarian05)","officialTitle":"A Phase 3, Open-Label, Multicenter, Randomized Study of Raludotatug Deruxtecan (MK-5909, R-DXd) With or Without Bevacizumab Versus Standard-of-Care Platinum-Based Doublet Chemotherapy With or Without Bevacizumab in Participants With Advanced Platinum-Sensitive High-Grade Serous or High-Grade Endometrioid Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Have Progressed During First-Line PARPi Maintenance (ENGOT-ov107 / GOG-3142 / REJOICE-Ovarian05)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery. High-grade means the cancer cells grow and spread quickly. This trial includes types of OC that started in cells that cover the ovaries, in the lining of the belly, or in the fallopian tubes.\n\nThe usual treatment for high-grade OC may include one or both of these:\n\n* Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing.\n* Bevacizumab, which is a targeted therapy that works to control how specific types of cancer cells grow and spread and targets tumor blood vessels.\n\nResearchers want to learn about the trial medicine, raludotatug deruxtecan (also called R-DXd or MK-5909), when given with and without bevacizumab and how participants respond to it. R-DXd is an antibody drug conjugate (ADC). An ADC is a type of medicine that attaches to a specific target on cancer cells and delivers treatment to destroy those cells.\n\nThe goals of this trial are to learn if participants who receive R-DXd, with or without bevacizumab, live longer overall and without their cancer growing or spreading compared to those who receive usual treatment.","conditions":["Ovarian Cancer","Peritoneal Cancer","Fallopian Tube Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"R-DXd"},{"type":"DRUG","name":"Bevacizumab"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Paclitaxel"},{"type":"DRUG","name":"Gemcitabine"},{"type":"DRUG","name":"Pegylated liposomal doxorubicin (PLD)"}],"enrollment":646,"startDate":"2026-10-07","completionDate":"2031-08-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"The main inclusion criteria include but are not limited to the following:\n\n* Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n* Has received 1 line of platinum-based therapy with a minimum of 4 cycles of platinum-doublet chemotherapy and have platinum-sensitive disease.\n* Has received a poly (ADP-ribose) polymerase inhibitor (PARPi) as maintenance treatment after the first line platinum-based chemotherapy course and experienced radiographic progression during treatment or within 42 days of the last dose of PARPi.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization.\n* Has recovered from any AEs due to previous anticancer therapies.\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer.\n* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active GI bleeding within 6 months before randomization.\n* Has uncontrolled or significant cardiovascular disease.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of randomization, severe asthma, severe chronic obstructive pulmonary disease \\[COPD\\], restrictive lung disease, pleural effusion) and any autoimmune, connective tissue, or inflammatory disorders with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis), or prior pneumonectomy.\n* Has received chronic steroid treatment, with some exceptions.\n* Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial ovarian cancer, abdominal fistula or GI perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam.\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years.","locations":[{"facility":"MemorialCare Orange Coast Medical Center ( Site 0032)","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orlando Health Cancer Institute ( Site 0018)","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lahey Clinic ( Site 0042)","city":"Burlington","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"JPS Oncology and Infusion Center ( Site 0019)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center ( Site 2700)","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center ( Site 2701)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital ( Site 5304)","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-free Survival (PFS)","Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["ovarian-cancer","als"],"drugSlugs":[],"locationSlugs":["fountain-valley-california","orlando-florida","burlington-massachusetts","fort-worth-texas","jerusalem-israel","tel-aviv-israel","tainan-taiwan"],"enrichment":{"headline":"Phase 3: testing R-DXd for Ovarian Cancer","inPlainEnglish":"Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body (metastatic) and may not be removed with surgery.","whoItsFor":["Ages 18 Years to any","Women only","The main include but are not limited to the following:","Has a histologically or cytologically documented advanced high-grade serous or high-grade endometrioid epithelial ovarian, primary peritoneal, or fallopian tube cancer","Has received 1 line of platinum-based therapy with a minimum of 4 cycles of platinum-doublet chemotherapy and have platinum-sensitive disease","Has received a poly (ADP-ribose) polymerase inhibitor (PARPi) as maintenance treatment after the first line platinum-based chemotherapy course and experienced radiographic progression during treatment or within 42 days of the last dose of PARPi","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization","Has recovered from any AEs due to previous anticancer therapies"],"whoShouldSkip":["include but are not limited to the following:","Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline ovarian cancer","Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active GI bleeding within 6 months before randomization","Has uncontrolled or significant cardiovascular disease","Has received chronic steroid treatment, with some exceptions","Has current, clinically relevant bowel obstruction (including subocclusive disease) including obstruction related to underlying epithelial ovarian cancer, abdominal fistula or GI perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam","Has known additional malignancy that is progressing or has required active treatment within the past 3 years"],"whatHappens":"If you join, the listed intervention(s) are R-DXd, Bevacizumab, or Carboplatin. The registry lists allocation as randomized. Researchers are looking for new ways to treat advanced, high-grade ovarian cancer (OC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 646 people at 7 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.155Z"},{"nctId":"NCT07743645","title":"Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention","officialTitle":"Developing Biomarker-Supported SSD Prevention","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The University of Texas Health Science Center, Houston","sponsorClass":"OTHER","summary":"The purpose of this study is to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns","conditions":["Schizophrenia Spectrum Disorders (SSD)"],"keywords":["Risk Reduction Therapy (RRT)","Prevention","family history of schizophrenia spectrum disorder"],"interventions":[{"type":"BEHAVIORAL","name":"Psychosocial intervention group"}],"enrollment":100,"startDate":"2026-09-01","completionDate":"2031-04-01","sex":"ALL","minAge":"9 Years","maxAge":"26 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Family history of SSD (defined as first-degree (e.g., a parent or a sibling), second-degree (e.g., an uncle or a grandparent), or other combinations of biological relatives in the family have or likely have a diagnosis of SSD or other closely related severe mental illnesses equivalent to at least 25% of genetic sharing) per medical record review and/or parent/legal guardian/self report and confirmed by a structured interview;\n2. screening positive for two or more risk factors targeted by the intervention;\n3. aged ≥ 9 and \\<26 years of birthday;\n4. Participants and parent(s)/legal guardian(s)/other family member(s) agree to participate;\n5. psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks.\n\nExclusion Criteria:\n\n1. Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview;\n2. Current or past antipsychotic medication use to specifically treat a psychotic disorder;\n3. major medical and neurological conditions;\n4. moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments;\n5. current drug or alcohol use that impacts functioning and study engagement;\n6. Not able to give assent, permission, or consent;\n7. Not able to undergo MRI.","locations":[{"facility":"The University of Texas Health Science Center at Houston","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yizhou Ma, PhD","phone":"713-486-2740","email":"Yizhou.Ma@uth.tmc.edu"},{"name":"Oluwabunmi Akindona, BA","phone":"713-486-2740","email":"Oluwabunmi.Akindona@uth.tmc.edu"}],"primaryOutcomes":["Change in persistent distressing psychotic-like experiences as assessed by a modified Prodromal Questionnaire Brief-Child Version (PQ-BC) questionnaire"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Not a traditional drug phase: Psychosocial intervention group for Schizophrenia Spectrum Disorders (SSD)","inPlainEnglish":"This study wants to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns","whoItsFor":["Ages 9 Years to 26 Years","screening positive for two or more risk factors targeted by the intervention;","aged ≥ 9 and \\<26 years of birthday;","Participants and parent(s)/legal guardian(s)/other family member(s) agree to participate;","psychiatrically stable and have no major changes in antidepressant, stimulant, or antipsychotic medication in the past 4 weeks"],"whoShouldSkip":["Current or past history of psychotic disorders or clinical high risk for psychosis (CHR-p) per study interview;","Current or past antipsychotic medication use to specifically treat a psychotic disorder;","major medical and neurological conditions;","moderate to severe intellectual disabilities or mild intellectual disabilities but expected to have difficulty completing the study assessments;","current drug or alcohol use that impacts functioning and study engagement;","Not able to undergo MRI"],"whatHappens":"If you join, the listed intervention(s) are Psychosocial intervention group. The registry lists allocation as na. This study wants to compare the effect of a brief family-based psychosocial intervention that addresses modifiable SSD risk factors on persistent and distressing psychotic-like experiences in children and young adults with a family history of SSD and high versus low baseline SSD-like brain patterns","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Houston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.043Z"},{"nctId":"NCT07743853","title":"Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator","officialTitle":"Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator in Total Hip Arthroplasty: a Randomized Double-Blind Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Poznan University of Medical Sciences","sponsorClass":"OTHER","summary":"Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period. However, the extent to which intravenous dexmedetomidine influences perioperative inflammatory biomarkers and clinical recovery in patients undergoing total hip arthroplasty under regional anesthesia remains unclear.\n\nThis prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the effects of two doses of intravenous dexmedetomidine administered during spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, and quality of recovery following elective primary total hip arthroplasty.","conditions":["Hip Osteoarthritis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Dexmedetomidine"},{"type":"DRUG","name":"Dexmedetomidine"}],"enrollment":90,"startDate":"2026-08-01","completionDate":"2027-11-30","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 50-90 years.\n* Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Planned spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block.\n* Ability to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate or inability to provide written informed consent.\n* Contraindications to spinal anesthesia.\n* Contraindications to PENG block.\n* Allergy or hypersensitivity to dexmedetomidine, ropivacaine, bupivacaine, or study medications.\n* Second- or third-degree atrioventricular block without a permanent pacemaker.\n* Resting heart rate \\<50 beats/min.\n* Severe hepatic impairment (Child-Pugh class C).\n* Severe renal failure requiring dialysis.\n* Chronic opioid therapy (\\>3 months before surgery).\n* Chronic treatment with α2-adrenergic agonists.\n* Cognitive impairment or inability to complete postoperative questionnaires.\n* Infection at the injection site.\n* Coagulopathy or ongoing anticoagulation precluding neuraxial anesthesia according to current guidelines.\n* Revision total hip arthroplasty.\n* Simultaneous bilateral total hip arthroplasty.\n* Participation in another interventional clinical trial within the previous 30 days.","locations":[{"facility":"Poznan University of Medical Sciences","city":"Poznan","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"MAlgorzata Reysner, MD PhD","phone":"+48 61 8310122","email":"mreysner@ump.edu.pl"},{"name":"Malgorzata Reysner, MD PhD","phone":"","email":""}],"primaryOutcomes":["Change in the Systemic Immune-Inflammation Index (SII)"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["poznan-poland"],"enrichment":{"headline":"Not a traditional drug phase: testing Placebo for Hip Osteoarthritis","inPlainEnglish":"Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period.","whoItsFor":["Ages 50 Years to 90 Years","Adults aged 50-90 years","Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis","American Society of Anesthesiologists (ASA) physical status I-III","Planned spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block"],"whoShouldSkip":["Contraindications to spinal anesthesia","Contraindications to PENG block","Allergy or hypersensitivity to dexmedetomidine, ropivacaine, bupivacaine, or study medications","Second- or third-degree atrioventricular block without a permanent pacemaker","Resting heart rate \\<50 beats/min","Severe hepatic impairment (Child-Pugh class C)","Severe renal failure requiring dialysis"],"whatHappens":"If you join, the listed intervention(s) are Placebo, Dexmedetomidine, or Dexmedetomidine. The registry lists allocation as randomized. Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Poznan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.508Z"},{"nctId":"NCT07743983","title":"A Study of BGM0504 in Early T2DM With Obesity","officialTitle":"A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BrightGene Bio-Medical Technology Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This trial is conducted in China. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, efficacy and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.","conditions":["Type 2 Diabetes (T2DM)"],"keywords":[],"interventions":[{"type":"DRUG","name":"BGM0504"},{"type":"DRUG","name":"semaglutide"}],"enrollment":372,"startDate":"2026-09-17","completionDate":"2028-09-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* ○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening.\n\n  * BMI 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening.\n  * Have HbA1c between ≥7.5% and ≤10.5% at screening.\n  * FPG ≤15.0 mmol/L at screening.\n  * If hypertensive: SBP \\<180 mmHg and DBP \\<110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks.\n  * Willing to comply with protocol, use effective contraception, and provide informed consent.\n\nExclusion Criteria:\n\n* ● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes.\n\n  * Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months.\n  * History of acute/chronic pancreatitis.\n  * Medullary thyroid carcinoma, MEN 2A/2B, or family history.\n  * Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence).\n  * Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias.\n  * Hemorrhagic or ischemic stroke within 6 months.\n  * Severe renal disease or eGFR ≤60 mL/min/1.73 m² (CKD-EPI).\n  * Pregnant or lactating woman.\n  * Prior clinical trial participation with investigational drug or device within 3 months.\n  * Other situations that are deemed as inappropriate for participation by investigators.","locations":[{"facility":"Nanjing Drum Tower Hospital（The Affiliated Hospital of Nanjing University Medical School）","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zhu","phone":"+86025-68182432","email":"zhudalong@nju.edu.cn"}],"primaryOutcomes":["Proportion of Participants Achieving HbA1c < 7.0% and Body Weight Reduction ≥ 10% from Baseline"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["nanjing-china"],"enrichment":{"headline":"Phase 3: testing BGM0504 for Type 2 Diabetes (T2DM)","inPlainEnglish":"The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise. Over 52 weeks of once weekly treatment, how well it works and safety are evaluated, including the rate of diabetes remission at 12 weeks after treatment discontinuation.","whoItsFor":["Ages 18 Years to 75 Years","○ Have been diagnosed with type 2 diabetes mellitus (T2DM)， disease duration ≤5 years, treatment naïve with ≥8 weeks diet/exercise, or off antidiabetic therapy ≥8 weeks prior to screening","body-mass index (BMI) 28.0-35.0 kg/m² at screening, with stable weight (±5%) for 3 months prior to screening","Have HbA1c between ≥7.5% and ≤10.5% at screening","FPG ≤15.0 mmol/L at screening","If hypertensive: SBP \\<180 mmHg and DBP \\<110 mmHg at enrollment, on stable (≥2 weeks) ≤2 antihypertensives, or no medication with diet/exercise ≥4 weeks"],"whoShouldSkip":["● Previous diagnosis of type 1 diabetes, special type diabetes or gestational diabetes","Prior use of antidiabetics or systemic glucocorticoids within 8 weeks, prior GLP-1/GIP/GCG receptor agonists with intolerance/poor response, or weight-loss drugs within 3 months","History of acute/chronic pancreatitis","Medullary thyroid carcinoma, MEN 2A/2B, or family history","Malignancy within 5 years (except treated BCC/SCC, cervical/PSC/thyroid papillary carcinoma in situ with no recurrence)","Severe cardiac conditions within 6 months: NYHA III/IV HF, unstable angina, MI, CABG/stent, severe arrhythmias","Hemorrhagic or ischemic stroke within 6 months"],"whatHappens":"If you join, the listed intervention(s) are BGM0504, or semaglutide. The registry lists allocation as randomized. The aim is to compare BGM0504 Injection 15 mg with semaglutide 1.0 mg in Chinese T2DM patients with obesity and inadequate control despite diet and exercise.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 372 people at Nanjing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.734Z"},{"nctId":"NCT07745374","title":"Safety and Feasibility of DBS for Bipolar Depression","officialTitle":"Deep Brain Stimulation for Bipolar Depression: Assessing the Safety and Use of Intracranial Neurophenotyping of State Switches","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation. This approach could establish a new paradigm for personalized neuromodulation therapy that uses real-time neural monitoring to optimize outcomes while minimizing risks. By incorporating bilateral, dual-site LFP monitoring from both the SCC and amygdala, this research will allow the researchers to assess the therapeutic efficacy of continuous SCC-DBS and develop novel safety biomarkers that could transform the clinical management of DBS therapy in psychiatry. The findings will have immediate implications for clinical practice and will advance the study team's fundamental understanding of the neural circuits underlying mood regulation and dysregulation in bipolar disorder.","conditions":["Bipolar I Disorder","Bipolar Depression"],"keywords":["deep brain stimulation","safety","subcallosal cingulate","local field potentials","Bipolar 1 depression"],"interventions":[{"type":"DEVICE","name":"Medtronic Percept PC DBS system"}],"enrollment":5,"startDate":"2026-09-21","completionDate":"2028-10","sex":"ALL","minAge":"22 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 22-70 years\n* Ability to provide written informed consent\n* Primary diagnosis of Bipolar I Disorder confirmed by SCID-5\n* Current major depressive episode (MDE) of at least 12 months duration\n* Stable control of mania for a minimum of 1 year\n* Agreement to remain on current anti-mania medication regimen\n* Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline\n* Young Mania Rating Scale (YMRS) score \\<12 at screening and baseline\n* Treatment-resistant depression: failure to respond to at least 4 adequate trials of antidepressant treatment in the current episode. Antidepressant treatments include: Medications (Must include 2 antidepressant medications from different pharmacological classes), Psychotherapy, ECT, repetitive transcranial magnetic stimulation (rTMS), IV ketamine or intra-nasal esketamine.\n* All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit.\n* Able to provide informed consent\n* English-speaking\n* Deemed suitable surgical candidate by neurosurgical evaluation\n* Under care of treating psychiatrist willing to collaborate with study team\n* Able to reside in New York Metropolitan area during first 6 months or willing/able to travel monthly to study site\n* Provision of at least two emergency contacts age ≥22 residing within reasonable proximity\n\nExclusion Criteria\n\n* Current manic or hypomanic episode (YMRS ≥12)\n* Rapid cycling pattern (≥4 mood episodes in the past 12 months)\n* Active suicidal ideation with intent or plan\n* Suicide attempt within six months prior to baseline\n* Current psychotic symptoms\n* Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder\n* History (current and/or lifetime) of one or more schizophrenia-spectrum or other psychotic disorders including: schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, and major depressive disorder with psychosis (unipolar or bipolar), and/or psychotic depression (unipolar or bipolar) (does not include psychosis occurring in the context of a manic episode of a subject with bipolar disorder)\n* Substance use disorder (moderate or severe) within 6 months\n* Presence of any type of dementia / Major Neurocognitive Disorder / significant cognitive impairment interfering with study participation\n* Subject has had a prior VNS Therapy or deep brain stimulation (DBS) implant\n* Subject has a diagnosis of Substance Use Disorder as defined by the DSM-V without sustained remission (12 months or longer)\n* History of borderline or severe personality disorder, as determined by clinical judgment, which would significantly interfere with a subject's participation in the study\n* Active primary diagnosis of one or more of the following disorders: obsessive-compulsive disorder, eating disorder, or post-traumatic stress disorder\n* Cognitive or psychiatric deficit (e.g., amnesia, delirium) that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments\n* Current or lifetime history of psychotic features in any major depressive episode (MDE)\n* Treatment with another investigational device or investigational drugs\n* Contraindications to MRI (metallic implants, claustrophobia unmanageable with anxiolytics)\n* Contraindications to general anesthesia or neurosurgery\n* Significant structural brain abnormalities precluding safe electrode placement\n* Active infection or immunocompromised state\n* Active unstable medial condition (diabetes, heart disease, hypertension, cancer, endocrine)\n* BMI \\>35; and/or CRP \\>3\n* Coagulopathy or anticoagulation that cannot be safely interrupted\n* Pregnancy or planning pregnancy during study period\n* Women of childbearing potential unwilling to use effective contraception\n* Prisoners or institutionalized individuals\n* Decisionally impaired individuals (unless previously consented when capacitated)\n* Special status patients (employees, VIPs, celebrities, public figures) unless consented before special status known","locations":[{"facility":"Center for Advanced Circuit Therapeutics, Clinical Neurosciences Center, Mount Sinai West","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ellie Rapp","phone":"646-493-1607","email":"ellie.rapp@mssm.edu"},{"name":"Avantika Vardhan","phone":"","email":"avantika.vardhan@mssm.edu"}],"primaryOutcomes":["Hamilton Depression Rating Scale (HDRS)"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Medtronic Percept PC DBS system for Bipolar I Disorder","inPlainEnglish":"This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches. The researchers propose to accomplish this by incorporating monitoring of the SCC local field potentials (LFP) for depression tracking and amygdala LFP monitoring for mania prediction while treating Bipolar I patients with SCC DBS Stimulation.","whoItsFor":["Ages 22 Years to 70 Years","Primary diagnosis of Bipolar I Disorder confirmed by SCID-5","Current major depressive episode (MDE) of at least 12 months duration","Stable control of mania for a minimum of 1 year","Agreement to remain on current anti-mania medication regimen","Hamilton Depression Rating Scale-17 (HDRS-17) score ≥20 at screening and baseline","Young Mania Rating Scale (YMRS) score \\<12 at screening and baseline","All patients must be receiving at least one mood stabilizing medication at entry into the trial. Medication regimen must be stable for a minimum of 4 weeks before the baseline visit"],"whoShouldSkip":["Current manic or hypomanic episode (YMRS ≥12)","Rapid cycling pattern (≥4 mood episodes in the past 12 months)","Active suicidal ideation with intent or plan","Suicide attempt within six months prior to baseline","Current psychotic symptoms","Primary diagnosis of schizophrenia, schizoaffective disorder, or other psychotic disorder","Substance use disorder (moderate or severe) within 6 months"],"whatHappens":"If you join, the listed intervention(s) are Medtronic Percept PC DBS system. The registry lists allocation as na. This study addresses a critical unmet need in the treatment of bipolar disorder by investigating whether Subcallosal Cingulate (SCC) Deep Brain Stimulation (DBS) can safely and effectively treat treatment-resistant bipolar depression without inducing manic switches.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 5 people at New York. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.728Z"},{"nctId":"NCT07746427","title":"Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis","officialTitle":"Outcomes of a Digital Mindfulness Meditation App-Based Intervention in Adolescents With Moderate to Severe Atopic Dermatitis (MIND-AD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Weill Medical College of Cornell University","sponsorClass":"OTHER","summary":"Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients. The investigators hypothesize that regular use of a digital mindfulness meditation app will improve disease control and quality of life in adolescents with moderate to severe atopic dermatitis based on validated survey measures.","conditions":["Atopic Dermatitis","Eczema"],"keywords":["Meditation","mindfulness","digital health"],"interventions":[{"type":"BEHAVIORAL","name":"Digital App Mindfulness Meditation"},{"type":"BEHAVIORAL","name":"Mindfulness Meditation Sheet"}],"enrollment":40,"startDate":"2026-11-15","completionDate":"2028-07","sex":"ALL","minAge":"13 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Adolescents age 13-17 years.\n* Atopic dermatitis refractory to standard topical treatment including topical steroids or topical calcineurin inhibitors.\n* Moderate to severe atopic dermatitis via PO-SCORAD score on enrollment.\n\nExclusion Criteria\n\n* Started on a biologic agent (i.e. dupxient) within the past 3 months.\n* Mild atopic dermatitis via PO-SCORAD score on enrollment.","locations":[{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dana A O'Toole, MD","phone":"646-962-3410","email":"wcmpedsallergy@med.cornell.edu"}],"primaryOutcomes":["Mean Atopic Dermatitis Control Tool (ADCT) score."],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Digital App Mindfulness Meditation for Atopic Dermatitis","inPlainEnglish":"Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention. The investigators aim to identify an accessible, effective digital health intervention for these patients.","whoItsFor":["Ages 13 Years to 17 Years","Adolescents age 13-17 years","Atopic dermatitis refractory to standard topical treatment including topical steroids or topical calcineurin inhibitors","Moderate to severe atopic dermatitis via PO-SCORAD score on enrollment"],"whoShouldSkip":["Started on a biologic agent (i.e. dupxient) within the past 3 months","Mild atopic dermatitis via PO-SCORAD score on enrollment"],"whatHappens":"If you join, the listed intervention(s) are Digital App Mindfulness Meditation, or Mindfulness Meditation Sheet. The registry lists allocation as randomized. Atopic dermatitis is well reported to have a significant impact on well-being in adolescents with atopic dermatitis, without clear recommendations for intervention.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.832Z"},{"nctId":"NCT07746505","title":"Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery","officialTitle":"Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","sponsorClass":"OTHER","summary":"This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.","conditions":["General Anesthesia","Aged","Intraoperative Hypotension","Anxiety"],"keywords":["Remimazolam","Midazolam","Elderly","Non-cardiac surgery","Anesthesia induction","Hemodynamic stability","Quality of recovery"],"interventions":[],"enrollment":1000,"startDate":"2026-06-15","completionDate":"2027-06-16","sex":"ALL","minAge":"65 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 65 years or older.\n2. Scheduled for elective non-cardiac surgery under general anesthesia.\n3. American Society of Anesthesiologists physical status I to IV.\n4. Planned airway management with tracheal intubation or a laryngeal mask airway.\n5. Written informed consent provided by the participant or the participant's legally authorized representative.\n\n   \\-\n\nExclusion Criteria:\n\n1. Long-term preoperative benzodiazepine use.\n2. Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.\n3. History of drug abuse or alcoholism within the past 2 years.\n4. No preoperative cognitive assessment available.\n5. Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.\n\n7.Refusal to provide informed consent.\n\n\\-","locations":[{"facility":"The Second Affiliated Hospital of Zhejiang University School of Medicin","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"min Yan, doctor","phone":"+86 13757118632","email":"zryanmin@zju.edu.cn"}],"primaryOutcomes":["Intraoperative Hypotension Burden Measured by the Time-Weighted Average of Mean Arterial Pressure (TWA-MAP) Below an Absolute Threshold (<65 mmHg) or a Relative Threshold (>20% Decrease From Baseline)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Su…","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics/pharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium.","whoItsFor":["Ages 65 Years to any","Age 65 years or older","Scheduled for elective non-cardiac surgery under general anesthesia","American Society of Anesthesiologists physical status I to IV","Planned airway management with tracheal intubation or a laryngeal mask airway"],"whoShouldSkip":["Long-term preoperative benzodiazepine use","Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs","History of drug abuse or alcoholism within the past 2 years","No preoperative cognitive assessment available","Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.357Z"},{"nctId":"NCT07746583","title":"A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine Clinical Practice","officialTitle":"A Non-Interventional, Multi-Centric, Single Country Observational Study to Assess the Safety and Effectiveness of Guselkumab After Ustekinumab (Originator or Biosimilar) in Moderate to Severe Psoriasis Patients in Clinical Routine","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Janssen-Cilag Kft.","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.","conditions":["Psoriasis"],"keywords":[],"interventions":[],"enrollment":100,"startDate":"2026-09-03","completionDate":"2029-01-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment\n* Participants who are currently being treated with Ustekinumab (either the originator or its biosimilar) and who are medically indicated to switch to Guselkumab, or for whom this switch is medically indicated, based on the current and valid national psoriasis (PsO) therapeutic protocol\n* Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab\n* Participants must sign an informed consent form (ICF) allowing for data collection and source data verification in accordance with local requirements\n\nExclusion criteria:\n\n* Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution\n* Pregnancy or breastfeeding\n* Currently enrolled in an interventional study\n* Currently enrolled in an observational study sponsored or managed by a Janssen company\n* Previous use of guselkumab in any indication in participant history","locations":[{"facility":"Semmelweis University","city":"Budapest","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Percentage of Participants Achieving Absolute Psoriasis Area Severity Index (aPASI) <=3 at Week 20 Following Switch from Ustekinumab to Guselkumab"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["budapest-hungary"],"enrichment":{"headline":"A Study of Guselkumab Given After Ustekinumab in Participants With Moderate to Severe Psoriasis in Routine …","inPlainEnglish":"The main purpose of this study is to describe how well Guselkumab works after switching from Ustekinumab in participants with moderate to severe psoriasis in a routine clinical setting. A long-term skin disease that causes red, scaly and sometimes painful, itchy patches on the skin.","whoItsFor":["Ages 18 Years to any","Must have a confirmed diagnosis of moderate-to-severe plaque psoriasis requiring systemic treatment","Participants who, based on the Investigator's decision, should initiate treatment with Guselkumab"],"whoShouldSkip":["Contraindication or hypersensitivity to Guselkumab or any other ingredient in the injection solution","Pregnancy or breastfeeding","Currently enrolled in an treatment study","Currently enrolled in an watch-and-measure (no experimental treatment required) study sponsored or managed by a Janssen company","Previous use of guselkumab in any indication in participant history"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Budapest. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.578Z"},{"nctId":"NCT07746635","title":"Fecal Microbiota Transplantation for Obese Women With Polyendocrine Metabolic Ovarian Syndrome","officialTitle":"Fecal Microbiota Transplantation for the Treatment of Polyendocrine Metabolic Ovarian Syndrome in Obese Women:A Phase Ⅰ/ⅡSingle-Arm Pilot Study and Planned Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Shanghai Changzheng Hospital","sponsorClass":"OTHER","summary":"This prospective, two-stage clinical trial aims to evaluate the safety, preliminary efficacy, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases:\n\nPhase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.\n\nPhase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomized controlled trial (RCT) designed to validate the clinical efficacy and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.","conditions":["PCOS (Polycystic Ovary Syndrome)"],"keywords":["FMT","PCOS","PMOS"],"interventions":[{"type":"BIOLOGICAL","name":"oral Fecal Microbiota Transplantation"},{"type":"OTHER","name":"Placebo"}],"enrollment":411,"startDate":"2025-04-15","completionDate":"2028-12-31","sex":"FEMALE","minAge":"20 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Females aged 20 to 40 years old.\n* 2\\. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS).\n* 3\\. Body Mass Index (BMI): \\>24.0 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24.0 kg/m² upwards).\n* 4\\. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center.\n* 5\\. Voluntary participation with signed Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Age \\< 20 or \\> 40 years.\n* Pregnancy or lactation.\n* Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month.\n* Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders.\n* Concurrent participation in other clinical trials.","locations":[{"facility":"Center for Reproductive Medicine,Shanghai Changzheng Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ningxia Sun, Chief","phone":"13817975897","email":"suesunchzh@126.com"},{"name":"Yichi Zhang, MD","phone":"19121277344","email":"zorzhang@163.com"}],"primaryOutcomes":["Clinical Pregnancy Rate","Biochemical Pregnancy Rate","Incidence of Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: testing oral Fecal Microbiota Transplantation for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"This prospective, two-stage clinical trial aims to measure the safety, preliminary how well it works, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases: Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET. Phase Ⅱ (Confirmatory RCT): A planned multicenter, prospective, randomly assigned controlled trial (RCT) designed to validate the clinical how well it works and underlying mechanisms of oral FMT capsules compared with control interventions, based on findings established in Phase Ⅰ.","whoItsFor":["Ages 20 Years to 40 Years","Women only","1\\. Females aged 20 to 40 years old","2\\. Meeting the diagnostic criteria for Polyendocrine Metabolic Ovarian Syndrome (PMOS)","3\\. Body Mass Index (body-mass index (BMI)): \\>24.0 kg/m²(covering overweight and obese patients according to Asian criteria, addressing the actual recruited cohort ranging from 24.0 kg/m² upwards)","4\\. Scheduled to undergo Frozen-Thawed Embryo Transfer (FET) at the Reproductive Medicine Center"],"whoShouldSkip":["Age \\< 20 or \\> 40 years","Pregnancy or lactation","Other endocrine disorders (e.g., Cushing's syndrome, thyroid dysfunction); severe organ dysfunction or impaired intestinal mucosal barrier; use of antibiotics, probiotics, or prebiotics within 1 month","Use of ovulation-modifying or anti-androgen drugs within 3 months; severe psychiatric disorders","Concurrent participation in other clinical trials"],"whatHappens":"If you join, the listed intervention(s) are oral Fecal Microbiota Transplantation, or Placebo. The registry lists allocation as randomized. This prospective, two-stage clinical trial aims to measure the safety, preliminary how well it works, and reproductive outcomes of oral Fecal Microbiota Transplantation (FMT) freeze-dried capsules in overweight and obese patients with Polyendocrine Metabolic Ovarian Syndrome (PMOS) undergoing Frozen-Thawed Embryo Transfer (FET).The study is implemented in two sequential phases: Phase Ⅰ (Pilot Exploration): A prospective, open-label, single-arm exploratory study in an initial evaluable cohort (n=11) to evaluate preliminary safety, dynamic gut microbiota colonization, endocrine/metabolic parameters, and pregnancy outcomes following FET.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 411 people at Shanghai. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.152Z"},{"nctId":"NCT07746687","title":"A Study of JNJ-95597528 in Participants With Inadequately Controlled Moderate to Severe Asthma","officialTitle":"A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of JNJ-95597528 for the Treatment of Adult Participants With Inadequately Controlled Moderate to Severe Asthma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Janssen Research & Development, LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how well JNJ-95597528 works when compared to placebo in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).","conditions":["Asthma"],"keywords":[],"interventions":[{"type":"DRUG","name":"JNJ-95597528"},{"type":"DRUG","name":"Placebo"}],"enrollment":440,"startDate":"2026-10-05","completionDate":"2029-09-11","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline\n* Confirmed variable expiratory flow (1 or more of the following) per global initiative for asthma (GINA) 2025 at the baseline visit: a. Evidence of bronchodilator responsiveness at screening and baseline: Post-bronchodilator forced expiratory volume in 1 second (FEV1) increases by greater than or equal to (\\>=) 200 milliliter (mL) and \\>=12 percent (%) of pre- bronchodilator value, or increase in peak expiratory flow (PEF) \\>=20%, if spirometry is not available; b. Demonstrated increase in lung function within the past 3 years after \\>=4 weeks of daily inhaled corticosteroids (ICS)-containing treatment, shown by: increase from baseline FEV1 by \\>=12% and \\>=200 mL, or increase in PEF by \\>=20%; c. Positive bronchial provocation test within the past 3 years, as defined by: \\>=20% decrease from baseline in FEV1 with standard doses of methacholine, or \\>=15% decrease from baseline in FEV1 with standardized hyperventilation, hypertonic saline or mannitol challenge, or decrease from baseline in FEV1 of \\>10% and \\>200 mL with standardized exercise challenge\n* Inhaled corticosteroid: Prescribed medium- or high-dose ICS for at least 1 year and a stable dose of medium- or high-dose ICS for at least 3 months prior to the screening visit per GINA 2025: • High-dose ICS is defined as a total daily dose \\>=500 microgram (mcg) fluticasone propionate or equivalent, • Medium-dose ICS is defined as a total daily dose \\>=250 to 500 mcg fluticasone propionate or equivalent\n* Additional controller medication: Must be on a stable dose of at least 1 additional maintenance asthma controller, in addition to ICS, per GINA 2025, for at least 3 months prior to screening (for example, long-acting beta-agonist \\[LABA\\], long-acting muscarinic antagonist \\[LAMA\\] \\[can be combined with ICS in 1 inhaler or can be separate inhalers\\], leukotriene receptor antagonist \\[LTRA\\])\n* Asthma control questionnaire, 5-item (ACQ-5) score \\>=1.5 at the screening visit and the baseline visit\n\nExclusion criteria:\n\n* History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment\n* Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts\n* Experienced primary efficacy failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling\n* Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma\n* Current smokers or former smokers with a smoking history \\>=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes","locations":[{"facility":"Allianz Research Institute, Inc.","city":"Westminster","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boston Specialists","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Institute","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Midwest Clinical Research LLC","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Equity Medical","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OK Clinical Research","city":"Edmond","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Allergy Asthma and Clinical Research Center Martha Tarpay MD","city":"Oklahoma","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"INAER - Investigacion en Alergias y Enfermedades Respiratorias","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Medicina Respiratoria IMER","city":"Córdoba","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fundacion Scherbovsky","city":"Mendoza","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto De Especialidades De La Salud SRL","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"IBAMEDICA Propiedad de IBA Santa Fe S.A.S","city":"Santa Fe","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"China Japan Friendship Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Changzhou No 2 Peoples Hospital","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ningbo medical center lihuili hospital","city":"Ningbo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanxi Bethune Hospital","city":"Taiyuan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tel Aviv Sourasky Medical Center","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Idaimae Minami4jo Internal Medicine","city":"Sapporo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Shinagawa Hospital","city":"Shinagawa City","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Asthma Exacerbations Through Week 48"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["westminster-california","boston-massachusetts","minneapolis-minnesota","st-louis-missouri","the-bronx-new-york","edmond-oklahoma","oklahoma-texas","buenos-aires-argentina","c-rdoba-argentina","mendoza-argentina","rosario-argentina","santa-fe-argentina","beijing-china","changzhou-china","ningbo-china","taiyuan-china","tel-aviv-israel","sapporo-japan","shinagawa-city-japan"],"enrichment":{"headline":"Phase 2: testing JNJ-95597528 for Asthma","inPlainEnglish":"This study wants to assess how well JNJ-95597528 works when compared to dummy treatment (placebo) in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).","whoItsFor":["Ages 18 Years to 85 Years","Medically stable on the basis of physical examination, medical history, and vital signs performed at screening or at baseline","Asthma control questionnaire, 5-item (ACQ-5) score \\>=1.5 at the screening visit and the baseline visit"],"whoShouldSkip":["History of uncontrolled, significant renal, cardiac, vascular, pulmonary (other than asthma), gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances that makes the participant unsuitable for the trial per investigator judgment","Any clinically important pulmonary disease other than asthma or pulmonary or systemic diseases, other than asthma, that are associated with elevated peripheral eosinophil counts","Experienced primary how well it works failure (no response within 16 weeks) or an adverse event (AE) requiring discontinuation related to agents inhibiting interleukin (IL)-13, IL-4Rα, and IL-4 signaling","Participants with either of the following events within the 2 weeks prior to the screening visit: a. Treatment with systemic steroids (oral or parenteral) for worsening asthma, b. Hospitalization or an emergency medical care visit for worsening asthma","Current smokers or former smokers with a smoking history \\>=20 pack-years. Former smokers must have stopped smoking within 6 months of the screening visit. This includes participants using vaping products and e-cigarettes"],"whatHappens":"If you join, the listed intervention(s) are JNJ-95597528, or Placebo. The registry lists allocation as randomized. This study wants to assess how well JNJ-95597528 works when compared to dummy treatment (placebo) in adult participants with moderate to severe asthma (long-term condition that affects the airways in your lungs).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 440 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.348Z"},{"nctId":"NCT07747467","title":"A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis","officialTitle":"A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study Utilizing a Master Protocol to Investigate the Safety and Tolerability of Multiple Study Interventions in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.","conditions":["Colitis, Ulcerative"],"keywords":["Ulcerative Colitis","Anti-Interleukin-18 (anti-IL-18)","Inflammatory bowel disease","aletekitug","GSK1070806","Gastrointestinal Diseases"],"interventions":[{"type":"BIOLOGICAL","name":"Aletekitug (GSK1070806)"}],"enrollment":8,"startDate":"2026-09-03","completionDate":"2029-03-21","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC, in the assessment of the investigator, must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis.\n* Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture/stenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening (\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening.\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions .\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (ATs) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* History of a significant allergic reaction (anaphylaxis, urticaria) or significant sensitivity to study intervention or any constituents of the study interventions (including excipients).\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site.","locations":[{"facility":"GSK Investigational Site","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Number of Participants with Adverse Events (AEs)","Number of Participants with Serious AEs (SAEs)","Number of Participants who Discontinue Study Intervention due to AEs","Number of Participants with Clinically Significant Changes in Laboratory Readings","Number of Participants with Clinically Significant Changes in Vital Signs","Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Aletekitug (GSK1070806) for Colitis, Ulcerative","inPlainEnglish":"This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC). The platform design uses one single master protocol that explains how the overall study is organized, whereas each treatment, as sub-study will be tested to see how well the study drug works and how it affects participants.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC, in the assessment of the investigator, must be available","Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection","Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy)","Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines)","May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy"],"whoShouldSkip":["Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis","Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture/stenosis within the small bowel or colon","Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy","Have a history of malignant neoplasm within the last 5 years","Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease","Have any active, chronic, or recurrent infections based on the investigator's assessment","Have history of opportunistic infections within 1 year of screening ("],"whatHappens":"If you join, the listed intervention(s) are Aletekitug (GSK1070806). The registry lists allocation as na. This study will look at how safe and tolerable different treatments are for adults who have moderate to severe ulcerative colitis (UC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 8 people at Oxford. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.220Z"},{"nctId":"NCT07747480","title":"A Sub Study to Investigate the Safety and Tolerability of Aletekitug in Participants With Moderate To Severe Ulcerative Colitis","officialTitle":"A Phase 1b, Non-Randomized, Open-Label, Repeat-Dose, Single Center Study to Investigate the Safety and Tolerability of Aletekitug in Advanced Therapy Naïve Participants With Moderate to Severe Ulcerative Colitis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.","conditions":["Colitis, Ulcerative"],"keywords":["Ulcerative Colitis","Anti-Interleukin-18 (anti-IL-18)","Inflammatory bowel disease","Aletekitug","GSK1070806","Gastrointestinal Diseases"],"interventions":[{"type":"BIOLOGICAL","name":"Aletekitug"}],"enrollment":16,"startDate":"2026-09-03","completionDate":"2028-03-05","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC must be available.\n* Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection.\n* Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy).\n* Documentation of a surveillance colonoscopy (performed according to local standard) within 12 months before screening (may be performed during screening) for participants with pancolitis of \\>8 years duration or left-sided colitis of \\>12 years duration, or primary sclerosing cholangitis\n* Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines).\n* May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy.\n* Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)\n\nExclusion Criteria:\n\n* Participants with current diagnosis of Crohn's disease (CD) or Inflammatory bowel disease-unclassified (IBD-U) or a history of radiation colitis, microscopic colitis or ischemic colitis. Have currently known complications of UC such as fulminant colitis, or toxic megacolon, stoma, or stricture/stenosis within the small bowel or colon.\n* Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy.\n* Have a history of malignant neoplasm within the last 5 years.\n* Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease\n* Have any active, chronic, or recurrent infections based on the investigator's assessment.\n* Have history of opportunistic infections within 1 year of screening\n* Have history or presence of significant medical illness including but not limited to cardiovascular, respiratory, gastrointestinal (excluding UC), hepatic, renal, endocrine, hematologic, neurological, and psychiatric disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of the data.\n* Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:\n* Have significant allergies to humanized monoclonal antibodies.\n* Have clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions\n* Have had previous colectomy (total or subtotal), or any other manifestation that might require surgery while enrolled in the trial.\n* Have ostomy or ileoanal pouch.\n* Have received any of the following for treatments of UC:\n\n  * Immunomodulatory medications, including cyclosporine, tacrolimus, mycophenolate mofetil, thalidomide, within 4 weeks before screening endoscopy.\n  * Topical (rectal) treatment of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of screening endoscopy.\n  * Have received approved or investigational advanced therapy (Ats) (i.e., biologics or small molecules including biosimilars).\n  * Interferon therapy within 8 weeks before screening endoscopy.\n  * Agents that deplete B- or T-cells (e.g., rituximab) within 12 months of baseline. Participants remain excluded if there is evidence of persistent targeted lymphocyte depletion at the time of screening endoscopy.\n* Had Clostridium difficile infection within 30 days of screening endoscopy or have a positive test result at screening, or other intestinal pathogen within 30 days before screening endoscopy.\n* Participant must not have signs of an ongoing infection related to an intestinal pathogen.\n* In the investigator's opinion, any clinically significant abnormalities of laboratory results from chemistry, hematology or urinalysis tests obtained at the screening visit that cannot be attributed to the underlying moderate-to-severe UC.\n* Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.\n* Positive for hepatitis B or C, HIV (Human Immunodeficiency Virus), as assessed by method available at each site;\n* Uncontrolled hypertension (i.e., blood pressure consistently measures \\>=140/90 millimeters of mercury (mmHg) while actively taking 1 or more antihypertensive medications).","locations":[{"facility":"GSK Investigational Site","city":"Oxford","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Number of Participants with Adverse events (AEs)","Number of Participants with Serious AEs (SAEs)","Number of Participants who Discontinue Study Intervention due to AEs","Number of Participants with Clinically Significant Changes in Laboratory Readings","Number of Participants with Clinically Significant Changes in Vital Signs","Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Readings"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Phase 1: testing Aletekitug for Colitis, Ulcerative","inPlainEnglish":"This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC). This study is the sub-study of the platform trial.","whoItsFor":["Ages 18 Years to 75 Years","Diagnosis of UC for greater than or equal (\\>=) 3 months before screening. Appropriate documentation of endoscopy and biopsy results consistent with the diagnosis of UC must be available","Active UC with a modified Mayo score (mMS) of 5 to 9 points and endoscopy sub score of 2 to 3 within 14 days before baseline biopsy collection","Active disease beyond the rectum (greater than \\[\\>\\]15 centimeter \\[cm\\] of active disease from the anal verge at the screening colonoscopy)","Demonstrated an inadequate response to, loss of response to, or intolerance to conventional therapy (e.g., oral 5- aminosalicyclic acid \\[5-ASA\\] compounds, corticosteroids, thiopurines)","May have been receiving a conventional therapy if the prescribed dose has been stable for the required time period before the screening endoscopy","Must meet contraception requirements if a female participant is a woman of childbearing potential (WOCBP)"],"whoShouldSkip":["Have prior history of dysplasia of the gastrointestinal tract or found to have dysplasia, other than completely removed low-grade dysplastic lesions, in any biopsy performed during the screening endoscopy","Have a history of malignant neoplasm within the last 5 years","Have history of lymphoproliferative disorder, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease","Have any active, chronic, or recurrent infections based on the investigator's assessment","Have history of opportunistic infections within 1 year of screening","Have evidence of active or latent Tuberculosis (TB) as documented by medical history, examination, and TB testing at Screening:","Have significant allergies to humanized monoclonal antibodies"],"whatHappens":"If you join, the listed intervention(s) are Aletekitug. The registry lists allocation as na. This goal of this sub-study is to learn how safe and tolerable the study drug, aletekitug (anti-IL-18), in participants with moderately to severely active ulcerative colitis (UC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 16 people at Oxford. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.203Z"},{"nctId":"NCT07747701","title":"Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring","officialTitle":"Ultra-early Identification of Futile Recanalization After Reperfusion Therapy in Acute Ischemic Stroke Based on Cerebral Autoregulation Monitoring: a Multicenter, Prospective, Interventional Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Beijing Shijitan Hospital, Capital Medical University","sponsorClass":"OTHER","summary":"This multicenter, prospective, and interventional diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.","conditions":["Acute Ischemic Stroke","Cerebral Autoregulation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"NIRS-based cerebral oxygenation and blood pressure monitoring"},{"type":"PROCEDURE","name":"Carotid compression test"}],"enrollment":227,"startDate":"2026-07-31","completionDate":"2027-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18\n2. Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery).\n3. National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation.\n4. Pre-stroke modified Rankin Scale (mRS) score ≤ 1.\n5. Symptom onset ≤ 24 hours.\n6. For patients with symptom onset within 6 hours: ASPECTS ≥ 6; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3.\n7. Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3).\n8. Patient or legally authorized representative provides written informed consent.\n\nExclusion Criteria:\n\n1. Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors.\n2. Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery.\n3. Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias.\n4. Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock).\n5. Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy.\n6. Severe systemic active infection, multiple organ failure, or expected survival \\< 6 months.\n7. Severe hepatic or renal dysfunction (ALT/AST \\> 3× upper limit of normal; estimated glomerular filtration rate \\< 30 mL/min) or severe coagulation disorders (platelet count \\< 40 × 10⁹/L, APTT \\> 50 s, INR \\> 3.0).\n8. Blood glucose \\< 2.7 mmol/L or \\> 22.2 mmol/L.\n9. Heart failure with NYHA class \\> II, or persistent systolic blood pressure \\< 100 mmHg.\n10. Central nervous system infection or intracranial tumor.\n11. Unstable vital signs.\n12. Severe alcohol dependence or drug dependence.\n13. Cognitive impairment or psychiatric disorders that may affect follow-up assessments.\n14. Pregnant or breastfeeding women.\n15. Participation in another clinical drug or device study within the past 30 days.\n16. Local skin damage or other conditions preventing proper placement of monitoring electrodes.\n17. Severe agitation or other conditions that interfere with data acquisition.\n18. Any other condition judged by investigators to potentially affect study results.","locations":[{"facility":"Beijing Shijitan Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital)","city":"Dalian","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Harbin Medical University","city":"Heilongjiang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Weifang People's Hospital Affiliated to Weifang Medical University","city":"Shandong","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Simeng Wang","phone":"010-63925615","email":"wsm990419@163.com"},{"name":"Shen Li","phone":"010-63925616","email":"lishen@mail.ccmu.edu.cn"}],"primaryOutcomes":["Distribution of Modified Rankin scale"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["beijing-china","dalian-china","heilongjiang-china","shandong-china"],"enrichment":{"headline":"Not a traditional drug phase: NIRS-based cerebral oxygenation and blood pressure monitoring for Acute Ischemic Stroke","inPlainEnglish":"This multicenter, prospective, and treatment diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.","whoItsFor":["Ages 18 Years to any","Diagnosis of acute ischemic stroke caused by anterior circulation large vessel occlusion (intracranial internal carotid artery or M1 segment of the middle cerebral artery)","National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 at presentation","Pre-stroke modified Rankin Scale (mRS) score ≤ 1","Symptom onset ≤ 24 hours","For patients with symptom onset within 6 hours: ASPECTS ≥ 6; for patients with symptom onset between 6 and 24 hours: age ≤ 80 years and ASPECTS ≥ 3","Underwent mechanical thrombectomy and achieved successful recanalization (mTICI 2b-3)"],"whoShouldSkip":["Pre-procedural baseline imaging showing significant intracranial hemorrhagic transformation, intracranial arterial dissection, large chronic cerebral infarction, or intracranial metastasis from malignant tumors","Any degree of stenosis, plaque, dissection, severe tortuosity, or imaging evidence of unstable/vulnerable plaque in the target-side or bilateral common carotid artery or the origin of the internal carotid artery","Known history of carotid sinus hypersensitivity syndrome, severe autonomic dysfunction, sick sinus syndrome, high-grade atrioventricular conduction block, or other malignant arrhythmias","Refractory malignant hypertensive crisis (systolic blood pressure persistently ≥ 200 mmHg despite standardized intravenous antihypertensive therapy, or hemodynamic instability with shock)","Known severe allergy to contrast agents or anesthetic drugs, or contraindications to antiplatelet/anticoagulation therapy","Severe systemic active infection, multiple organ failure, or expected survival \\< 6 months","Severe hepatic or renal dysfunction (ALT/AST \\> 3× upper limit of normal; estimated glomerular filtration rate \\< 30 mL/min) or severe coagulation disorders (platelet count \\< 40 × 10⁹/L, APTT \\> 50 s, INR \\> 3.0)"],"whatHappens":"If you join, the listed intervention(s) are NIRS-based cerebral oxygenation and blood pressure monitoring, or Carotid compression test. The registry lists allocation as na. This multicenter, prospective, and treatment diagnostic accuracy study enrolls patients undergoing thrombectomy with intraoperative cerebral autoregulation monitoring and follows them up at predefined time points up to 90 days post-enrollment.This study aims to evaluate a monitoring system based on cerebral autoregulation function and explore its predictive value for adverse neurological outcomes at the ultra-early stage following mechanical thrombectomy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 227 people at 4 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.223Z"},{"nctId":"NCT07747909","title":"Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial","officialTitle":"Effect of Orlistat on Metabolic and Hormonal Features in Women With Polycystic Ovary Syndrome (PCOS): a Randomized Controlled Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Khyber Medical University Peshawar","sponsorClass":"OTHER","summary":"This randomized controlled clinical trial aims to evaluate the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or placebo plus standard lifestyle advice for three months. The study will assess the effect of orlistat on hormonal parameters, glucose metabolism, lipid profile, liver function, anthropometric measures, non-alcoholic fatty liver disease, and quality of life to determine its effectiveness as an adjunctive treatment for women with PCOS.","conditions":["Polycystic Ovary Syndrome"],"keywords":["PCOS","Orlistat","Lifestyle Intervention","Quality of Life"],"interventions":[{"type":"DRUG","name":"Orlistat"},{"type":"DRUG","name":"Placebo"},{"type":"BEHAVIORAL","name":"Standard Lifestyle Advice"}],"enrollment":120,"startDate":"2026-01-01","completionDate":"2026-08-10","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Females aged 18-45 years.\n* Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):\n* Oligomenorrhea or amenorrhea.\n* Clinical or biochemical hyperandrogenism.\n* Polycystic ovaries on ultrasonography.\n* Body mass index (BMI) between 18.5 and 35 kg/m² (Asian criteria).\n\nExclusion Criteria:\n\n* Current or recent use of oral contraceptives, ovulation induction medications, anti-obesity medications, cholesterol-lowering medications, or other therapies/supplements known to affect insulin physiology or androgen metabolism (e.g., inositols, curcumin, lipoic acid, cinnamon, gymnemic, or other botanical extracts).\n* Women undergoing in vitro fertilization (IVF) treatment.\n* Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus.\n* Presence of severe renal or liver disease.\n* Menopausal, pregnant, or breastfeeding women.\n* Anti-Müllerian Hormone (AMH) \\< 0.7 ng/mL.","locations":[{"facility":"Ayub Teaching Hospital","city":"Abbottābād","state":"Khyber Pakhtunkhwa","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Prof Dr Ruqqiya Sultana, MBBS","phone":"+92 314 5014992","email":"ruqqia_sultana@yahoo.com"},{"name":"Dr Noman Arif, PhD","phone":"+92 345 3059391","email":"nomanarif@kmu.edu.pk"}],"primaryOutcomes":["Polycystic Ovary Syndrome (PCOS) Features","Luteinizing Hormone/Follicle Stimulating Hormone (LH/FSH) Ratio","Anti-Müllerian Hormone (AMH)","Follicle Stimulating Hormone (FSH)","Luteinizing Hormone (LH)","Free Testosterone","Fasting Blood Glucose"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["abbott-b-d-pakistan"],"enrichment":{"headline":"Not a traditional drug phase: testing Orlistat for Polycystic Ovary Syndrome","inPlainEnglish":"This randomly assigned controlled clinical trial aims to measure the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS). Eligible women diagnosed with PCOS according to the Rotterdam criteria will be randomly assigned to receive either orlistat plus standard lifestyle advice or dummy treatment (placebo) plus standard lifestyle advice for three months.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Females aged 18-45 years","Diagnosis of polycystic ovary syndrome (PCOS) according to the Rotterdam Criteria (presence of any two of the following):","Oligomenorrhea or amenorrhea","Clinical or biochemical hyperandrogenism","Polycystic ovaries on ultrasonography","Body mass index (body-mass index (BMI)) between 18.5 and 35 kg/m² (Asian criteria)"],"whoShouldSkip":["Women undergoing in vitro fertilization (IVF) treatment","Known congenital adrenal hyperplasia, thyroid disorders, hyperprolactinemia, or diabetes mellitus","Presence of severe renal or liver disease","Menopausal, pregnant, or breastfeeding women","Anti-Müllerian Hormone (AMH) \\< 0.7 ng/mL"],"whatHappens":"If you join, the listed intervention(s) are Orlistat, Placebo, or Standard Lifestyle Advice. The registry lists allocation as randomized. This randomly assigned controlled clinical trial aims to measure the effect of orlistat on the metabolic and hormonal features of women with polycystic ovary syndrome (PCOS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Abbottābād. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.794Z"},{"nctId":"NCT07748208","title":"A Study Evaluating the Safety of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With Advanced Breast Cancer (ABC) and Type 2 Diabetes","officialTitle":"A Phase II Prospective, Open-Label Safety Study of Inavolisib and Fulvestrant With or Without Palbociclib in Participants With PIK3CA-Mutated Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer and Type 2 Diabetes","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study will evaluate the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.","conditions":["Breast Cancer","Diabetes Type II"],"keywords":[],"interventions":[{"type":"DRUG","name":"Inavolisib"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Palbociclib"}],"enrollment":40,"startDate":"2026-10-30","completionDate":"2029-06-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Type 2 diabetes with laboratory fasting blood glucose \\< 185 milligrams per deciliter (mg/dL) and HbA1c \\<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing\n* Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease\n* Confirmed diagnosis of HR+/HER2- breast cancer\n* Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any history of Type 1 diabetes\n* Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of active bowel inflammation or active inflammatory bowel disease","locations":[{"facility":"MedStar Washington Hosp Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Grady Memorial Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital Midtown","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University Hospital","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists St Francis - Grand Island","city":"Grand Island","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nebraska Cancer Specialists","city":"Omaha","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Hospital Long Island Clinical Research","city":"Mineola","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone?s Perlmutter Cancer Center - 160 E 34th St","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University","city":"Morgantown","state":"West Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pan American Center for Oncology Trials, LLC","city":"Dorado","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: GO45322 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage of Participants With Grade 4 Hyperglycemia Adverse Events (AEs) After Cycle 1","Percentage of Participants Hospitalized for Hyperglycemia or its Complications After Cycle 1","Percentage of Participants with AEs After Cycle 1"],"hasResults":false,"conditionSlugs":["breast-cancer","type-2-diabetes"],"drugSlugs":["palbociclib"],"locationSlugs":["washington-d-c-district-of-columbia","atlanta-georgia","grand-island-nebraska","omaha-nebraska","mineola-new-york","new-york-new-york","morgantown-west-virginia","dorado-puerto-rico"],"enrichment":{"headline":"Phase 2: testing Inavolisib for Breast Cancer","inPlainEnglish":"This study will measure the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.","whoItsFor":["Ages 18 Years to any","Type 2 diabetes with laboratory fasting blood glucose \\< 185 milligrams per deciliter (mg/dL) and HbA1c \\<= 8% on any stable anti-hyperglycemic regimen excluding insulin short-term insulin dosing","Eligible for triplet of inavolisib, fulvestrant and palbociclib: no prior systemic therapy for locally advanced unresectable or metastatic disease","Confirmed diagnosis of HR+/HER2- breast cancer","Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)","Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1","Adequate hematologic and organ function within 14 days prior to initiation of study treatment"],"whoShouldSkip":["Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required","Metaplastic breast cancer","Any history of Type 1 diabetes","Severe hyper- or hypoglycemia event within 6 months of initiation of study treatment","Any history of leptomeningeal disease or carcinomatous meningitis","Known and untreated, or active central nervous system (CNS) metastases Participants with a history of treated CNS metastases are eligible","Active inflammatory or conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye"],"whatHappens":"If you join, the listed intervention(s) are Inavolisib, Fulvestrant, or Palbociclib. The registry lists allocation as na. This study will measure the safety of inavolisib in combination with fulvestrant, with or without palbociclib, in participants with PIK3CA-mutated, HR+, HER2-negative ABC and type 2 diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.720Z"},{"nctId":"NCT07749053","title":"Guangdong Provincial Endometriosis Clinical Research Cohort","officialTitle":"Guangdong Provincial Endometriosis Clinical Research Cohort","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Li Li","sponsorClass":"OTHER","summary":"Endometriosis is a chronic condition that may cause pelvic pain, ovarian cysts, infertility, and recurrent symptoms. This prospective observational cohort study will enroll women aged 18 to 45 years with endometriosis and age- and body mass index-matched healthy women. Participants will receive routine clinical care, and the study will not assign medications or procedures. Baseline clinical information will be collected, and participants will be followed for 24 months, every 3 months during the first year and every 6 months thereafter. The study will assess cyst recurrence, pain recurrence, pregnancy and live birth outcomes, and other long-term clinical outcomes. It will also evaluate associations between disease characteristics, rASRM stage, routine medical treatment, and subsequent clinical and reproductive outcomes, and will support the establishment of an endometriosis clinical research database.","conditions":["Endometriosis"],"keywords":["Prospective Cohort","Ovarian Endometrioma","Pelvic Pain","Disease Recurrence","Pregnancy Outcome","Live Birth","Infertility"],"interventions":[],"enrollment":716,"startDate":"2026-02-02","completionDate":"2029-07","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Inclusion Criteria:\n\nFemale participants aged 18 to 45 years. Able and willing to provide written informed consent. For the endometriosis cohort: diagnosis of endometriosis based on clinical findings, imaging, and/or laparoscopy.\n\nFor the endometriosis cohort: availability of complete baseline clinical data, including revised American Society for Reproductive Medicine stage and lesion type.\n\nFor the healthy control cohort: healthy women matched by age and body mass index to participants in the endometriosis cohort.\n\nFor the healthy control cohort: regular menstrual cycles of 28 to 30 days.\n\nExclusion Criteria:\n\nFor the endometriosis cohort: concurrent malignant tumor or severe cardiac, hepatic, or renal disease.\n\nFor the endometriosis cohort: previous hysterectomy. For the endometriosis cohort: a mental disorder that prevents adherence to study follow-up.\n\nExclusion Criteria:\n\n\\-","locations":[{"facility":"Guangdong Women and Children Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Li Li, MD","phone":"+85213631446859","email":"lili-1406@163.com"}],"primaryOutcomes":["Endometriosis-Related Pain Recurrence"],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Guangdong Provincial Endometriosis Clinical Research Cohort","inPlainEnglish":"Endometriosis is a chronic condition that may cause pelvic pain, ovarian cysts, infertility, and recurrent symptoms. This prospective watch-and-measure (no experimental treatment required) cohort study will enroll women aged 18 to 45 years with endometriosis and age- and body mass index-matched healthy women.","whoItsFor":["Ages 18 Years to 45 Years","Women only","who can join:","For the endometriosis cohort: availability of complete baseline clinical data, including revised American Society for Reproductive Medicine stage and lesion type","For the healthy control cohort: healthy women matched by age and body mass index to participants in the endometriosis cohort","For the healthy control cohort: regular menstrual cycles of 28 to 30 days"],"whoShouldSkip":["For the endometriosis cohort: concurrent malignant tumor or severe cardiac, hepatic, or renal disease","For the endometriosis cohort: previous hysterectomy. For the endometriosis cohort: a mental disorder that prevents adherence to study follow-up"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 716 people at Guangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.118Z"},{"nctId":"NCT07749092","title":"Kimchi Powder on Gut Health","officialTitle":"The Effect of Kimchi Powder Supplementation on Gut Health: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial (KIMCHI-GUT Trial)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pusan National University Yangsan Hospital","sponsorClass":"OTHER","summary":"The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects of Kimchi powder supplementation on gut health in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) for 8 weeks.","conditions":["Irritable Bowel Syndrome - Diarrhoea"],"keywords":["Kimchi","Irritable bowel syndrome - Diarrhea","Gut microbiome","Fermented food"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Kimchi power"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":100,"startDate":"2026-08-03","completionDate":"2027-12-30","sex":"ALL","minAge":"20 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults, male or female, aged 20 to 70 years\n* Body mass index of 25 kg/m2 or more and less than 30 kg/m2\n* Meeting the Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D), defined as Bristol Stool Form Scale type 6 or 7 in 25% or more of bowel movements from 2 weeks before screening through the day of the screening visit\n* No inflammatory bowel disease or malignancy\n* Provided written agreement to refrain from consuming kimchi-containing foods for the duration of the study (approximately 2 months)\n\nExclusion Criteria:\n\n* Drug-induced constipation\n* Constipation secondary to another condition, such as diabetes mellitus or thyroid disease\n* History of intra-abdominal surgery other than appendectomy (including gastrectomy, gastric bypass, gallbladder or biliary tract surgery, pancreatectomy, bowel resection with particular reference to the ileum, and colorectal surgery or insertion procedures)\n* Uncontrolled hypertension (resting blood pressure 160/100 mmHg or higher)\n* Uncontrolled diabetes mellitus (fasting blood glucose 160 mg/dL or higher)\n* Uncontrolled hypothyroidism or hyperthyroidism\n* AST or ALT concentration 3 times or more the upper limit of the reference range of the testing laboratory\n* Creatinine concentration 2 times or more the upper limit of the reference range of the testing laboratory\n* Severe cardiovascular or cerebrovascular disease or malignancy within the previous 6 months\n* Psychiatric disorder such as severe affective disorder, schizophrenia, or substance use disorder, or current use of related psychiatric medication (intermittent use for sleep disturbance is permitted)\n* Severe alcohol use disorder\n* Heavy smoking (20 cigarettes per day or more)\n* Hypersensitivity to the main ingredient or components of the study food\n* Severe gastrointestinal symptoms such as heartburn or dyspepsia\n* Use of medications or foods that may affect the study results, including kimchi and probiotics\n* For female volunteers, suspected pregnancy, lactation, or plan to become pregnant during the study period\n* Participation in another drug clinical trial within one month prior to the screening date, or planned participation\n* Judged unsuitable for participation by the principal investigator for reasons other than those listed above","locations":[{"facility":"Pusan National University Yangsan Hospital","city":"Yangsan","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Professor","phone":"+82-55-360-2860","email":"drsaylee@gmail.com"}],"primaryOutcomes":["Change in IBS Severity Scoring System (IBS-SSS) total score"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["yangsan-south-korea"],"enrichment":{"headline":"Not a traditional drug phase: Kimchi power for Irritable Bowel Syndrome - Diarrhoea","inPlainEnglish":"The investigators will conduct a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to investigate the effects of Kimchi powder supplementation on gut health in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) for 8 weeks.","whoItsFor":["Ages 20 Years to 70 Years","Adults, male or female, aged 20 to 70 years","Body mass index of 25 kg/m2 or more and less than 30 kg/m2","Meeting the Rome IV criteria for diarrhea-predominant irritable bowel syndrome (IBS-D), defined as Bristol Stool Form Scale type 6 or 7 in 25% or more of bowel movements from 2 weeks before screening through the day of the screening visit","No inflammatory bowel disease or malignancy","Provided written agreement to refrain from consuming kimchi-containing foods for the duration of the study (approximately 2 months)"],"whoShouldSkip":["Drug-induced constipation","Constipation secondary to another condition, such as diabetes mellitus or thyroid disease","History of intra-abdominal surgery other than appendectomy (including gastrectomy, gastric bypass, gallbladder or biliary tract surgery, pancreatectomy, bowel resection with particular reference to the ileum, and colorectal surgery or insertion procedures)","Uncontrolled hypertension (resting blood pressure 160/100 mmHg or higher)","Uncontrolled diabetes mellitus (fasting blood glucose 160 mg/dL or higher)","Uncontrolled hypothyroidism or hyperthyroidism","AST or ALT concentration 3 times or more the upper limit of the reference range of the testing laboratory"],"whatHappens":"If you join, the listed intervention(s) are Kimchi power, or Placebo. The registry lists allocation as randomized. The investigators will conduct a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study to investigate the effects of Kimchi powder supplementation on gut health in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) for 8 weeks.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Yangsan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.442Z"},{"nctId":"NCT07749521","title":"Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems","officialTitle":"Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"University of Toronto","sponsorClass":"OTHER","summary":"Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression. As such, the Addressing Depression and Positive Parenting Techniques (ADAPT) intervention is a novel BPT tailored to address the unique emotional and cognitive needs of depressed parents to improve treatment outcomes.\n\nThe objective of this study is to determine the efficacy of ADAPT in reducing child emotional and behavioral difficulties compared to the gold-standard Incredible Years Parenting Program (IYPP).\n\nThis study is a 4-year, individually-randomized group treatment (IRGT), parallel-group trial. We aim to recruit 210 caregivers and their children (aged 6-11 years) seeking treatment for their child's emotional and behavioral difficulties from multiple mental health centres across Toronto, including but not limited to the University of Toronto, Centre for Addiction and Mental Health (CAMH), and Women's College Hospital (WCH).\n\nParticipants will be asked to complete research measures:\n\n* before randomization\n* post-treatment\n* 6 months after the end of treatment\n\nParticipants will be randomized to either the experimental ADAPT intervention - A 10-session virtual program (1 individual, 9 group) focused on emotion regulation, distress tolerance, and cognitive restructuring, or the control intervention: Incredible Years Parent Program (IYPP) - A 12-session gold-standard BPT delivered virtually.","conditions":["Depression / Major Depressive Disorder","Conduct Disorders in Children","Disruptive Behaviour in Children","Parenting Intervention"],"keywords":["behavioural parent training","depression","parenting skills","child disruptive behaviour"],"interventions":[{"type":"BEHAVIORAL","name":"ADAPT Treatment"},{"type":"BEHAVIORAL","name":"Incredible Years Parenting Program (IYPP)"}],"enrollment":210,"startDate":"2026-08-01","completionDate":"2030-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 18 years of age or above\n2. has a child aged 6-11 years with clinically elevated emotional and behavioural disorders (Abnormal Range, 90th percentile or above) on the Total Difficulties Scale or the Conduct Problems subscale of the Strength and Difficulties Questionnaire (SDQ)\n3. parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (\\>4 and \\<15)\n4. capacity to tolerate a virtual group context assessed by clinical interview\n\nExclusion Criteria:\n\n1. Parent shows active suicidal ideation, substance use disorder, or psychosis\n2. they cannot communicate in English\n3. child previously diagnosed with autism or an intellectual disability","locations":[{"facility":"Ontario Institute for Studies in Education (OISE)","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brendan Andrade, PhD","phone":"416-946-5905","email":"brendan.andrade@utoronto.ca"}],"primaryOutcomes":["Changes in child emotional and behavioral difficulties"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["toronto-canada"],"enrichment":{"headline":"Not a traditional drug phase: ADAPT Treatment for Depression / Major Depressive Disorder","inPlainEnglish":"Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression. As such, the Addressing Depression and Positive Parenting Techniques (ADAPT) intervention is a novel BPT tailored to address the unique emotional and cognitive needs of depressed parents to improve treatment outcomes.","whoItsFor":["Ages 18 Years to any","18 years of age or above","has a child aged 6-11 years with clinically elevated emotional and behavioural disorders (Abnormal Range, 90th percentile or above) on the Total Difficulties Scale or the Conduct Problems subscale of the Strength and Difficulties Questionnaire (SDQ)","parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (\\>4 and \\<15)","capacity to tolerate a virtual group context assessed by clinical interview"],"whoShouldSkip":["Parent shows active suicidal ideation, substance use disorder, or psychosis","they cannot communicate in English","child previously diagnosed with autism or an intellectual disability"],"whatHappens":"If you join, the listed intervention(s) are ADAPT Treatment, or Incredible Years Parenting Program (IYPP). The registry lists allocation as randomized. Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 210 people at Toronto. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.103Z"},{"nctId":"NCT07750535","title":"Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","officialTitle":"Prevalence and Risk Factors of Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Palermo","sponsorClass":"OTHER","summary":"Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a double-blind placebo-controlled wheat challenge. Steatosis was confirmed by ultrasound examination. Our retrospective data showed that the frequency of liver of steatosis was lower in NCWS than in IBS patients. In addition, it seems that pre-diagnosis avoidance of wheat in NCWS correlates with protection from steatosis. A subset of NCWS patients, recently exposed to wheat, with clinical features suggesting increased IP, seems to be predisposed to liver steatosis and fibrosis.\n\nTo validate the results of the retrospective study, the researchers planned the present prospective study, to analyze the prevalence of liver steatosis and fibrosis, evaluated by ultrasound (US) examination, FibroScan analysis \\[CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values\\], FIB-4 (Fibrosis-4) index, and NFS \\[Non-alcoholic fatty liver disease (NAFLD) Fibrosis Score\\], in patients with NCWS at the time of diagnosis, comparing them with two control populations of newly diagnosed IBS/FD and CeD patients.","conditions":["Metabolic Dysfunction-Associated Steatotic Liver Disease","Non Celiac Wheat Sensitivity","Irritable Bowel Syndrome","Functional Dyspepsia","Celiac Disease"],"keywords":["non-celiac wheat sensitivity","metabolic dysfunction-associated steatotic liver disease"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Prevalence and severity of liver steatosis and fibrosis,"}],"enrollment":250,"startDate":"2024-01-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"The inclusion/exclusion criteria used to select the study population have been previously validated in other retrospective studies. Additional exclusion criteria related to steatosis and other liver diseases and specifically required for this study were adopted.\n\nInclusion criteria for Non-Celiac Wheat Sensitivity (NCWS) patients\n\n* age \\>18 and \\<65 years;\n* subjects with wheat-dependent symptoms, both gastrointestinal and extra-intestinal;\n* negativity of IgA and IgG anti-deamidated gliadin peptide (DPG) antibodies, immunoglobulin (Ig)A and IgG anti-tissue transglutaminase (tTG) antibodies, and anti-endomysial antibodies (EMA);\n* absence of duodenal villous atrophy, documented in all patients carrying the human leukocyte antigen (HLA) DQ2 and/or DQ8 haplotypes (therefore regardless of the negativity of celiac disease (CeD)-specific serum antibodies), evaluated when the patients had consumed a minimum of 100g of pasta and/or bread a day, for at least 45 days;\n* absence of IgE-mediated wheat allergy (WA): negative skin prick-test and/or specific serum IgE assay for wheat, gluten and gliadin);\n* resolution of symptoms on a strict standard elimination diet (i.e. extended oligoantigenic, excluding wheat, cow's milk, egg, tomato and chocolate and other foods self-reported by the patient as causing symptoms), followed for at least 4 weeks, and the recurrence of the same symptoms after double-blind placebo-controlled challenge (DBPCC) with wheat (for further details see below);\n* complete medical records;\n* duration of follow-up longer than 12 months after initial diagnosis, with at least 2 outpatient visits during the follow-up period.\n\nInclusion criteria for Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) and other functional gastrointestinal disorders unrelated to NCWS or other food allergies/intolerances patients\n\n* age \\>18 and \\<65 years;\n* subjects diagnosed with IBS/FD and other functional gastrointestinal disorders, according to the Rome IV classification, 1 who did not specifically report symptoms/signs, whether gastrointestinal or extra-intestinal, following ingestion of wheat or other foods and who did not respond to gluten-free diet (GFD).\n\nInclusion criteria for Celiac Disease (CeD) patients\n\n* age \\>18 and \\<65 years;\n* subjects with gastrointestinal and extra-intestinal wheat-dependent symptoms that meet the diagnostic criteria of CeD 2: positivity of anti-tTG IgA and/or IgG antibodies and evidence of villous atrophy, according to the Marsh-Oberhuber classification, demonstrated by histology on duodenal biopsy;\n* clinical response to the GFD: resolution of gastrointestinal and/or extra-intestinal symptoms.\n\nExclusion criteria for all the patients enrolled in the study\n\n* self-exclusion of wheat from the diet and refusal to reintroduce it for diagnostic purposes, before entering the study;\n* drug abuse;\n* treatment with steroids and/or non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system (e.g., wheat allergy, microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.), neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity;\n* incomplete medical records;\n* lack of clinical follow-up for at least 12 months after diagnosis with \\>2 outpatient visits during the follow-up period.\n\nAdditional exclusion criteria related to liver steatosis and other liver diseases\n\n* absence of abdominal ultrasound (US) imaging performed before diagnosis (i.e. before starting the wheat-free/gluten-free diet in NCWS and CeD patients, and before any lifestyle modifications and/or drug/prebiotic/probiotic intake in IBS/FD patients);\n* incomplete clinical records, lacking the data considered for the present study;\n* chronic alcohol intake (\\>30 g/day for men and \\>20 g/day for women);\n* chronic hepatotropic virus infections \\[hepatitis B virus (HBV) and hepatitis C virus (HCV)\\];\n* autoimmune liver diseases;\n* congenital metabolic liver diseases (e.g. alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, porphyria, other storage diseases, etc.);\n* chronic long-term treatment with drugs associated with both macrovesicular (glucocorticoids, estrogens, tamoxifen, amiodarone, methotrexate, and 5-fluorouracil) and microvesicular (glucocorticoids, valproic acid, tetracycline, and zidovudine) steatosis.","locations":[{"facility":"Internal Medicine Unit, University Hospital of Palermo","city":"Palermo","state":"Palermo","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Internal Medicine Unit, \"Villa-Sofia-Cervello\" Hospital","city":"Palermo","state":"Palermo","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Antonio Carroccio, MD","phone":"+393477279879","email":"antonio.carroccio@unipa.it"}],"primaryOutcomes":["Prevalence and severity of liver steatosis and fibrosis by Ultrasound examination","Prevalence and severity of liver steatosis by FibroScan analysis","Prevalence and severity of liver steatosis and fibrosis by FIB-4","Prevalence and severity of liver steatosis and fibrosis by NFS"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["palermo-italy"],"enrichment":{"headline":"Not a traditional drug phase: Prevalence and severity of liver steatosis and fibrosis, for Metabolic Dysfunction-Associated Steatotic Liver Disease","inPlainEnglish":"Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome/Functional Dyspepsia (IBS/FD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a neither you nor the study doctors know who gets the real treatment compared with a dummy treatment wheat challenge.","whoItsFor":["Ages 18 Years to 65 Years"],"whoShouldSkip":["used to select the study population have been previously validated in other retrospective studies. Additional"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 250 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.441Z"},{"nctId":"NCT07752511","title":"Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism","officialTitle":"The Impact of Anticipated Illness Stigma and Illness Identity on Quality of Life in Men With Hypogonadism: A Comparative Study With Other Chronic Endocrine Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hacettepe University","sponsorClass":"OTHER","summary":"This study aims to systematically compare the levels of anticipated illness stigma and illness identity among men diagnosed with hypogonadism to those of men with other chronic endocrine conditions (e.g., diabetes mellitus, hypothyroidism, and hypertension). Furthermore, it examines whether these psychosocial variables predict quality-of-life deterioration specifically within the hypogonadism cohort.","conditions":["Hypogonadism, Male","Endocrine Disease","Hypertension"],"keywords":["Hypogonadism","Anticipated Stigma","Illness Identity","Quality of Life","Chronic Endocrine Diseases","Psychosocial Factors"],"interventions":[],"enrollment":90,"startDate":"2026-10-20","completionDate":"2027-10-20","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCases:\n\n* Male, aged 18 years or older.\n* Biochemically confirmed hypogonadism (total testosterone \\< 300 ng/dL with at least one clinical symptom).\n* Regular follow-up at the endocrinology outpatient clinic.\n* Fluent in reading and understanding Turkish.\n* Signed informed consent.\n\nControls:\n\n* Male, aged 18 years or older.\n* Diagnosed with diabetes, hypertension, or hypothyroidism under regular endocrinology follow-up.\n* Total testosterone ≥ 300 ng/dL.\n* Age-matched to a participant in the case group (±5 years).\n* Fluent in reading and understanding Turkish.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Active psychiatric diagnosis (e.g., active psychosis, bipolar disorder).\n* Chronic inflammatory or rheumatological diseases affecting body composition (e.g., chronic kidney disease, IBD, rheumatoid arthritis, SLE, ankylosing spondylitis).\n* Uncontrolled co-existing endocrine conditions or severe complications (e.g., HbA1c \\> 8.0%, diabetic neuropathy/nephropathy/retinopathy, non-euthyroid state).\n* Cognitive impairment or dementia precluding questionnaire completion.\n* Klinefelter syndrome.\n* Literacy limitations preventing completion of self-report measures.\n* Additional control exclusion: Diagnosis or clinical suspicion of hypogonadism.","locations":[{"facility":"Bingöl University Faculty of Physical Therapy and Rehabilitation","city":"Bingoel","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Malatya Training and Research Hospital","city":"Malatya","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Chronic Illness Anticipated Stigma Scale (CIASS) Score","Brief Illness Perception Questionnaire (Brief IPQ) Score"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["bingoel-turkey-t-rkiye","malatya-turkey-t-rkiye"],"enrichment":{"headline":"Anticipated Stigma, Illness Identity, and Quality of Life in Male Hypogonadism","inPlainEnglish":"This study aims to systematically compare the levels of anticipated illness stigma and illness identity among men diagnosed with hypogonadism to those of men with other chronic endocrine conditions (e.g., diabetes mellitus, hypothyroidism, and hypertension). Furthermore, it examines whether these psychosocial variables predict quality-of-life deterioration specifically within the hypogonadism cohort.","whoItsFor":["Ages 18 Years to any","Men only","Male, aged 18 years or older","Biochemically confirmed hypogonadism (total testosterone \\< 300 ng/dL with at least one clinical symptom)","Regular follow-up at the endocrinology outpatient clinic","Fluent in reading and understanding Turkish","Diagnosed with diabetes, hypertension, or hypothyroidism under regular endocrinology follow-up","Total testosterone ≥ 300 ng/dL","Age-matched to a participant in the case group (±5 years)"],"whoShouldSkip":["Active psychiatric diagnosis (e.g., active psychosis, bipolar disorder)","Chronic inflammatory or rheumatological diseases affecting body composition (e.g., chronic kidney disease, IBD, rheumatoid arthritis, SLE, ankylosing spondylitis)","Uncontrolled co-existing endocrine conditions or severe complications (e.g., HbA1c \\> 8.0%, diabetic neuropathy/nephropathy/retinopathy, non-euthyroid state)","Cognitive impairment or dementia precluding questionnaire completion","Klinefelter syndrome","Literacy limitations preventing completion of self-report measures","Additional control exclusion: Diagnosis or clinical suspicion of hypogonadism"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 90 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.038Z"},{"nctId":"NCT07753330","title":"Efficacy of Expectancy Focused Exposure Therapy for Anxiety Disorders","officialTitle":"Efficacy of Expectancy Focused Exposure Therapy in Reducing Fear and Preventing the Return of Anxiety Over Time: A Longitudinal Randomized Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of Chile","sponsorClass":"OTHER","summary":"This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders. Specifically, it examines whether Expectancy Focused Exposure (EFE), based on the inhibitory learning model, is more effective than Anxiety Focused Exposure (AFE) in reducing anxiety symptoms and preventing the return of fear over time. The study includes adults aged 18 years and older diagnosed with an anxiety disorder, including social anxiety disorder, specific phobia, generalized anxiety disorder, and panic disorder with or without agoraphobia. Anxiety disorders are highly prevalent and can significantly interfere with daily functioning, work performance, and interpersonal relationships. Exposure therapy is a central component of cognitive behavioral treatment for anxiety disorders. Traditional exposure approaches often focus on reducing anxiety during exposure sessions, but many individuals experience a return of fear after treatment. New theoretical models suggest that exposure may be more effective when designed to violate threat expectations and strengthen inhibitory learning. Participants will be recruited in sequential cohorts and randomly assigned to immediate treatment or a brief waitlist before treatment begins. Those assigned to the waitlist will start treatment at the next study step. When treatment begins, participants will receive either EFE or AFE. Both treatments consist of approximately 10 weekly individual psychotherapy sessions delivered by trained therapists. Participants will complete clinical assessments before treatment, during treatment, immediately after treatment, and at 6, 12, and 18 months after treatment completion. In AFE, exposure exercises are organized along an anxiety hierarchy and focus on reducing anxiety responses through repeated confrontation with feared stimuli. In EFE, exposure focuses on identifying and testing threat expectations, and exercises are designed to maximize expectancy violation and strengthen inhibitory learning. Potential risks include temporary emotional discomfort during exposure exercises. All sessions will be conducted by trained clinicians who monitor participant safety throughout the study. The results may help improve exposure-based treatments for anxiety disorders by identifying strategies that enhance long-term outcomes and reduce relapse.","conditions":["Anxiety Disorders","Panic Disorder","Social Anxiety Disorder (SAD)","Generalised Anxiety Disorder","Specific Phobia"],"keywords":["Exposure Therapy","Randomized Controlled Trial","Expectancy Violation","Optimized Exposure","Inhibitory Retrieval Model","Extinction Learning","Anxiety Disorders","Associative Map","Fear Extinction","Relapse Prevention"],"interventions":[{"type":"BEHAVIORAL","name":"Expectancy Focused Exposure"},{"type":"BEHAVIORAL","name":"Anxiety Focused Exposure"}],"enrollment":203,"startDate":"2026-07-01","completionDate":"2028-07-30","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Population Description The study sample will consist of adult participants from the general population seeking psychological treatment for anxiety-related problems. Participants will be recruited through multiple sources, including university mental health services, student wellbeing units, community mental health centers, social media advertisements, and other public outreach channels. Recruitment will be intentionally broad to maximize accessibility and ecological validity.\n\nScreening and Selection Procedures Eligibility will be determined through a multi-stage screening process. Initial Screening: DSM-5 Cross-Cutting Measures, Levels 1 and 2 Participants responding to recruitment will first complete the DSM-5 Level 1 Cross-Cutting Symptom Measure (APA, 2013; Spanish version APA, 2014). This self-report instrument includes 23 items assessing 13 domains of psychopathology over the past 14 days using a 5-point Likert scale. It has shown good reliability and clinical utility in prior studies (APA, 2014; Bravo et al., 2018).\n\nParticipants who meet threshold criteria for anxiety-related symptoms on the Level 1 measure will then complete the corresponding DSM-5 Level 2 anxiety measures to further characterize symptom severity.\n\nDisorder-Specific Symptom Assessment, Level 3 Participants who meet screening criteria on Levels 1 and 2 will complete disorder-specific symptom scales according to the anxiety disorder suspected or reported, including measures for social anxiety disorder, specific phobia, generalized anxiety disorder, and panic disorder with or without agoraphobia.\n\nDiagnostic Assessment Participants who remain eligible after the screening and disorder-specific symptom assessment will undergo a structured clinical interview using the Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5). The ADIS-5 will be used to establish the principal anxiety disorder diagnosis and to assess exclusion criteria, including psychotic disorder, bipolar disorder, high suicide risk, and severe or uncontrolled substance use disorder.\n\nInclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Age between 18 and 70 years.\n* Seeking treatment for anxiety-related difficulties.\n* Meet DSM-5 diagnostic criteria for a principal anxiety disorder, including:\n\nsocial anxiety disorder, specific phobia, generalized anxiety disorder, panic disorder with or without agoraphobia.\n\n* Diagnosis will be established using the ADIS-5 structured clinical interview.\n* For participants with generalized anxiety disorder, treatment will focus on the principal anxiety problem identified during assessment.\n* Present clinically significant anxiety symptoms associated with the principal diagnosis.\n* If currently taking anxiolytic medication, the dosage must have remained stable for at least three months before the start of treatment and should be maintained during the treatment phase whenever possible.\n* Willingness and ability to participate in weekly psychotherapy sessions and complete all study assessments.\n* Provide informed consent.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following conditions are present:\n\n* Current psychotic disorder.\n* Current manic or hypomanic episode, consistent with bipolar disorder.\n* High suicide risk requiring immediate clinical intervention.\n* Severe or uncontrolled substance use disorder.\n* Concurrent participation in psychological treatment specifically targeting the anxiety disorder during the study period.\n* Medical conditions that contraindicate exposure procedures (e.g., severe cardiovascular conditions).\n* Cognitive impairment or insufficient language proficiency that would interfere with participation in psychotherapy or completion of assessments.","locations":[{"facility":"Facultad de Ciencias Sociales, Universidad de Chile","city":"Santiago","state":"Santiago Metropolitan","country":"Chile","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Vanetza E Quezada-Scholz, PhD","phone":"+56977361470","email":"qvanetza@u.uchile.cl"}],"primaryOutcomes":["Change in standardized disorder-specific anxiety symptom severity"],"hasResults":false,"conditionSlugs":["als","anxiety"],"drugSlugs":[],"locationSlugs":["santiago-chile"],"enrichment":{"headline":"Not a traditional drug phase: Expectancy Focused Exposure for Anxiety Disorders","inPlainEnglish":"This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders. Specifically, it examines whether Expectancy Focused Exposure (EFE), based on the inhibitory learning model, is more effective than Anxiety Focused Exposure (AFE) in reducing anxiety symptoms and preventing the return of fear over time.","whoItsFor":["Ages 18 Years to 70 Years","Participants who meet threshold criteria for anxiety-related symptoms on the Level 1 measure will then complete the corresponding DSM-5 Level 2 anxiety measures to further characterize symptom severity"],"whoShouldSkip":[", including psychotic disorder, bipolar disorder, high suicide risk, and severe or uncontrolled substance use disorder","who can join:","Participants must meet all of the following criteria:","Age between 18 and 70 years","Seeking treatment for anxiety-related difficulties","Meet DSM-5 diagnostic criteria for a principal anxiety disorder, including:","social anxiety disorder, specific phobia, generalized anxiety disorder, panic disorder with or without agoraphobia"],"whatHappens":"If you join, the listed intervention(s) are Expectancy Focused Exposure, or Anxiety Focused Exposure. The registry lists allocation as randomized. This clinical trial evaluates whether an optimized exposure-based treatment improves long-term outcomes for adults with anxiety disorders.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 203 people at Santiago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.357Z"},{"nctId":"NCT07753850","title":"A Study of SL-325 in Crohn's Disease Patients","officialTitle":"A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SL-325 in Participants With Moderately to Severely Active Crohn's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Shattuck Labs, Inc.","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to evaluate the efficacy of SL-325 in adult participants with moderate to severely active Crohn's disease.\n\nThe study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.","conditions":["Crohn's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"SL-325"},{"type":"DRUG","name":"Placebo"}],"enrollment":232,"startDate":"2026-10-21","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening\n* Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450\n* SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following Crohn's disease treatments: corticosteroids, immunomodulators, or an approved anti-tumor necrosis factor (TNF), anti-integrin, anti-interleukin (IL)-12/23, anti-interleukin (IL)-23p19, or Janus kinase inhibitor (JAK)\n\nKey Exclusion Criteria:\n\n* Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD\n* CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement\n* Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome\n* Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of \\> 2 segments\n* Diagnosis of primary sclerosing cholangitis\n* Has a stoma, ileostomy, or colostomy.\n* Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion.\n* Has active tuberculosis (TB) or inadequately treated latent tuberculosis (LTBI)\n* Prior exposure to any anti-DR3 or anti-TL1A agent or agent with an anti-DR3 or anti-TL1A component","locations":[{"facility":"Clinical Trial Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Oxnard","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Temple City","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"West Hills","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Inverness","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Kissimmee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Naples","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Kansas City","state":"Kansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Houma","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Marrero","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Glen Burnie","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Liberty","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Maspeth","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trial Site","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shattuck Medical Director","phone":"919-864-2700","email":"clinicaltrials@shattucklabs.com"}],"primaryOutcomes":["Proportion of participants who achieve endoscopic response"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","oxnard-california","temple-city-california","west-hills-california","inverness-florida","kissimmee-florida","naples-florida","orlando-florida","tampa-florida","kansas-city-kansas","houma-louisiana","marrero-louisiana","glen-burnie-maryland","boston-massachusetts","liberty-missouri","st-louis-missouri","maspeth-new-york","cincinnati-ohio","columbus-ohio","nashville-tennessee"],"enrichment":{"headline":"Phase 2: testing SL-325 for Crohn's Disease","inPlainEnglish":"The primary purpose of this study is to measure the how well it works of SL-325 in adult participants with moderate to severely active Crohn's disease. The study consists of a screening period of up to 6 weeks, a 12-week induction period, 38-week maintenance period, 52-week long-term extension period, and a 10-week follow-up period.","whoItsFor":["Ages 18 Years to 80 Years","A diagnosis of Crohn's disease confirmed by endoscopy and histopathology ≥ 3 months prior to Screening","Moderately to severely active CD as defined by CDAI of ≥ 220 and ≤ 450","SES-CD score ≥ 6 if ileocolonic or colonic disease, or ≥ 4 if isolated ileal disease, as assessed by central review"],"whoShouldSkip":["Diagnosis of UC, indeterminate colitis, or any other gastrointestinal condition that could undermine the diagnosis of CD","CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement","Presence or suspicion of any of the following CD complications: intra-abdominal or perianal abscess; symptomatic stricture or colonic stenosis not passable in ileocolonoscopy, fistula, except for perianal fistula; active toxic megacolon or fulminant colitis; short bowel syndrome","Surgical bowel resection within 3 months before Screening, ≥ 3 bowel resections, or previous ileo-colonic resection of \\> 2 segments","Diagnosis of primary sclerosing cholangitis","Has a stoma, ileostomy, or colostomy","Has prior or current gastrointestinal dysplasia, other than a completely removed low-grade dysplastic lesion"],"whatHappens":"If you join, the listed intervention(s) are SL-325, or Placebo. The registry lists allocation as randomized. The primary purpose of this study is to measure the how well it works of SL-325 in adult participants with moderate to severely active Crohn's disease.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 232 people at 20 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.894Z"},{"nctId":"NCT07754084","title":"Comprehensive Clinical Prediction Rule for Acute Heart Failure","officialTitle":"Establishing a Comprehensive Clinical Prediction Rule for the Diagnosis of Acute Heart Failure in the Emergency Department","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Chinese University of Hong Kong","sponsorClass":"OTHER","summary":"The goal of this prospective observational cohort study is to establish a comprehensive clinical prediction rule integrating clinical characteristics, point-of-care testing (POCT) of NT-proBNP, an 8-point LUS, and a rapid cardiac assessment using bedside echocardiography for diagnosing acute heart failure (AHF) in the emergency department. A clinical prediction rule with high diagnostic accuracy will minimize delays and misdiagnoses, as well as the potential harm they may cause to patients. The primary outcome measure is the adjudicated AHF diagnosis. Secondary outcome measures include ED and discharge diagnosis of the patients.","conditions":["Acute Heart Failure (AHF)"],"keywords":["Acute Heart Failure","LUS","CXR","ECG","NT-proBNP"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Acute Heart Failure Diagnostic Method"}],"enrollment":560,"startDate":"2026-08-17","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult (aged ≥ 18 years)\n* Suspected AHF or acute dyspnea\n* Symptoms include shortness of breath, swelling of legs, orthopnea, paroxysmal nocturnal dyspnoea, exertional dyspnea or weight gain\n\nExclusion Criteria:\n\n* Trauma patients\n* Pregnancy\n* Unstable patients requiring invasive airway intervention\n* Patients who refuse to participate","locations":[{"facility":"Prince of Wales Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Mary Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tuen Mun Hospital","city":"Hong Kong","state":"","country":"Hong Kong","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Theresa Hui","phone":"+85235051698","email":"theresahui@cuhk.edu.hk"}],"primaryOutcomes":["Adjudicated acute heart failure diagnosis"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["hong-kong-hong-kong"],"enrichment":{"headline":"Not a traditional drug phase: Acute Heart Failure Diagnostic Method for Acute Heart Failure (AHF)","inPlainEnglish":"The goal of this prospective watch-and-measure (no experimental treatment required) cohort study is to establish a comprehensive clinical prediction rule integrating clinical characteristics, point-of-care testing (POCT) of NT-proBNP, an 8-point LUS, and a rapid cardiac assessment using bedside echocardiography for diagnosing acute heart failure (AHF) in the emergency department. A clinical prediction rule with high diagnostic accuracy will minimize delays and misdiagnoses, as well as the potential harm they may cause to patients.","whoItsFor":["Ages 18 Years to any","Adult (aged ≥ 18 years)","Suspected AHF or acute dyspnea","Symptoms include shortness of breath, swelling of legs, orthopnea, paroxysmal nocturnal dyspnoea, exertional dyspnea or weight gain"],"whoShouldSkip":["Unstable patients requiring invasive airway intervention","Patients who refuse to participate"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 560 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.433Z"},{"nctId":"NCT07754786","title":"A Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","officialTitle":"A Multicenter, Randomized, Double-blind, Parallel, and Positive-controlled Phase III Clinical Study to Evaluate the Equivalence of IBI3027 and Dupilumab Injection in Participants With Moderate to Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Innovent Biologics (Suzhou) Co. Ltd.","sponsorClass":"INDUSTRY","summary":"This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.\n\nStudy period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).\n\nAfter screening is completed, participants will be randomly grouped in a 1:1 ratio. On Day 1 (D1), they will receive a loading dose of either IBI3027 or Dupilumab Injection 600 mg by subcutaneous injection (SC), followed by 300 mg each time, SC administration, once every 2 weeks (Q2W), until the last administration on W44. After the treatment is completed, a 8-week safety follow-up will be conducted.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Dupilumab Injection"},{"type":"DRUG","name":"IBI3027"}],"enrollment":520,"startDate":"2026-09-15","completionDate":"2028-07-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key inclusion criteria:\n\n1. Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;\n2. Male or female participants aged 18 to 75;\n3. AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;\n4. Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;\n5. Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;\n6. As assessed by investigator, records indicating poor treatment response with topical local medications, or not suitable for topical treatment due to other medical reasons (such as severe adverse reactions or safety risks, etc.), within 6 months prior to the screening\n\nKey exclusion criteria：\n\n1. Have active skin diseases that may affect the assessment of AD (such as psoriasis or lupus erythematosus), or other skin complications caused by other diseases. Those who are in an acute exacerbation state of AD at the time of randomization (such as participants having rapidly progressing erythroderma or a tendency towards erythroderma, as assessed by the investigators);\n2. Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;\n3. Suspected immunosuppressive disease within 6 months prior to screen;\n4. Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);\n5. Participants at high risk of infection;\n6. Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;\n7. Positive for human immunodeficiency virus (HIV) antibody;\n8. Participants with syphilis infection;\n9. Positive for the hepatitis C virus (HCV) antibody and HCV RNA (if HCV antibody positive);\n10. Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA (if HBsAg positive);\n11. Previous use IL-4 and/or IL-13 targeting drugs (such as dupilumab, etc.) for the treatment of AD with no response or poor efficacy;\n12. Systemic use of IL-4Rα or IL-13 antibody treatment ≤ 3 months or 5 half-lives (if the half-life is known) prior to randomization;\n13. ≥ 2 bleach baths ≤ 2 weeks prior to randomization;\n14. Use of drugs containing main active ingredients such as compound glycyrrhizin or total polysaccharides of peony ≤ 2 weeks prior to randomization;\n15. Following treatments ≤4 weeks prior to randomization: a. systemic use of glucocorticoids or immunosuppressants; b. systemic use of traditional Chinese medicine; c. calcium channel-based anti-epileptic drugs, anti-serotonin agents, and opioid receptor antagonists, with antipruritic effects; d. ultraviolet therapy.\n16. Treatment of allergen-specific immunotherapy ≤ 6 months prior to randomization;\n17. Use of any cell depletion agents including but not limited to rituximab ≤12 months prior to randomization.","locations":[{"facility":"Southern Medical University Dermatology Hospital Medicine","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aoling Chen","phone":"0512-69566088","email":"aoling.chen@innoventbio.com"}],"primaryOutcomes":["The proportion of participants who achieved EASI-75"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 3: testing Dupilumab Injection for Atopic Dermatitis","inPlainEnglish":"This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio. Study period: It includes a screening period (4 weeks), a treatment period (44 weeks), and a follow-up period (8 weeks).","whoItsFor":["Ages 18 Years to 75 Years","Understand the requirements and process, voluntarily participate in clinical trials and sign consent, willing and able to comply with the requirements of protocol;","Male or female participants aged 18 to 75;","AD diagnosis at screening meeting the Hanifin-Rajka criteria, and the course of AD ≥ 1 year before screening as judged by the investigator;","Moderate to severe AD at screening and baseline, meeting all the following criteria: a. IGA score ≥ 3; b. EASI score ≥ 16; c. BSA≥10%;","Average daily PP-NRS score within 7 days prior to randomization ≥ 4 points;","As assessed by investigator, records indicating poor treatment response with topical local medications, or not suitable for topical treatment due to other medical reasons (such as severe adverse reactions or safety risks, etc.), within 6 months prior to the screening"],"whoShouldSkip":["Have history of active spring keratoconjunctivitis (VKC) and atopic keratoconjunctivitis (AKC) within 6 months prior to screen;","Suspected immunosuppressive disease within 6 months prior to screen;","Within 2 weeks prior to screen, systemic use of antimicrobial treatment (for viral, bacterial, fungal, or parasitic infections) or having superficial skin infections (such as impetigo);","Participants at high risk of infection;","Within 1 year prior to screen, recurrent herpes zoster or Kaposi's varicelliform eruption (≥ 2 times), disseminated herpes zoster or disseminated herpes simplex;","Positive for human immunodeficiency virus (HIV) antibody;","Participants with syphilis infection;"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab Injection, or IBI3027. The registry lists allocation as randomized. This study is expected to include approximately 520 patients with moderate to severe AD, and they will be randomly assigned to the treatment group (IBI3027) and the control group (Dupilumab Injection ) in a 1:1 ratio.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 520 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.706Z"},{"nctId":"NCT07755241","title":"A Study of AC-101 Tablets in Patients With Ulcerative Colitis","officialTitle":"A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of AC-101 Tablets in Patients With Moderately to Severely Active Ulcerative Colitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Accro Bioscience (Suzhou) Limited","sponsorClass":"INDUSTRY","summary":"This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will evaluate the efficacy, safety, and pharmacokinetics of AC-101 compared with placebo in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies. The study consists of a screening period (up to 4 weeks), a 12-week induction period, a 40-week extension period, and a 4-week safety follow-up period.","conditions":["Ulcerative Colitis (UC)"],"keywords":["IBD","AC-101","dose finding"],"interventions":[{"type":"DRUG","name":"AC-101"},{"type":"DRUG","name":"AC-101"},{"type":"DRUG","name":"Placebo"}],"enrollment":153,"startDate":"2026-09-10","completionDate":"2027-11-30","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 and ≤ 75 years；\n2. Must sign the Informed Consent Form and be willing to participate in the study.\n3. Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence.\n4. Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2.\n5. Documented failure to prior advanced therapies or prior conventional therapies\n6. Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:\n\n   1. Female participants of non-childbearing potential;\n   2. Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;\n   3. Male participants with a pregnant or non-pregnant female partner of childbearing potential must agree to use contraception during the treatment period and for at least 1 month after the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Severe extensive colitis.\n2. Hospitalization for exacerbation of UC within 12 weeks prior to screening.\n3. History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy.\n4. Adenomatous colonic polyps that have not been removed prior to study enrollment.\n5. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease.\n6. Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening.\n7. Presence of an ostomy or fistula.\n8. Risk of tuberculosis .\n9. History of current or prior serious opportunistic infection.\n10. Presence of active or chronic recurrent infection.\n11. Patients with any of the following hepatitis B screening results:\n\n    Acute or chronic hepatitis B infection; or Positive hepatitis B virus (HBV) test at screening (HBsAg positive); or HBsAg negative, hepatitis B core antibody (HBcAb) positive, with detectable HBV-DNA.\n12. Current hepatitis C infection, or positive hepatitis C virus (HCV) test at screening.\n13. Human immunodeficiency virus (HIV) infection/acquired immunodeficiency syndrome , or positive HIV antibody test at screening.\n14. Syphilis, or positive syphilis-specific antibody test at screening.\n15. Treatment with advanced therapies for UC within 8 weeks or 5 half-lives prior to randomization.\n16. Treatment with intravenous corticosteroids within 2 weeks prior to randomization.\n17. Treatment with leukocyte apheresis within 12 weeks prior to randomization.\n18. Treatment with intravenous immunoglobulins or plasmapheresis within 12 weeks prior to randomization.\n19. Treatment with lymphocyte-depleting therapy.\n20. History of fecal microbiota transplantation.\n21. Vaccination with live attenuated vaccines within 4 weeks prior to randomization, or a plan to receive such vaccines during the study period.\n22. Requirement for parenteral nutrition.\n23. History of myocardial infarction, acute stroke, transient ischemic attack, thromboembolic events, clinically significant arrhythmia, unstable angina, coronary artery bypass grafting, or severe pulmonary heart disease/pulmonary hypertension within 3 months prior to randomization, which, in the investigator's judgment, may affect the evaluation of study results.\n24. Presence of any other unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurological/psychiatric, or other medical condition that, in the investigator's judgment, may interfere with the study results.\n25. Known history of immunodeficiency; other acquired or congenital immunodeficiency disorders; or history of organ transplantation.\n26. History of malignancy within 5 years prior to screening, with the exception of adequately treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.\n27. Female patients who are pregnant, lactating, or have a positive serum pregnancy test at screening.\n28. Any other condition that, in the investigator's opinion, may affect the patient's safety or compliance, or preclude the patient from completing the study.","locations":[{"facility":"The First Affiliated Hospital, Sun Yat-sen University","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yin Lin","phone":"86-020-87330631","email":"zsyyiec2020@mail.sysu.edu.cn"}],"primaryOutcomes":["Clinical Remission"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 2: testing AC-101 for Ulcerative Colitis (UC)","inPlainEnglish":"This is a Phase Ⅱb, multicenter, randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC). The study will measure the how well it works, safety, and pharmacokinetics of AC-101 compared with dummy treatment (placebo) in patients who have had an inadequate response, loss of response, or intolerance to prior advanced therapies or to prior conventional therapies.","whoItsFor":["Ages 18 Years to 75 Years","Male or female participants aged ≥ 18 and ≤ 75 years；","Diagnosis of UC confirmed at least 3 months prior to screening, supported by both endoscopic and histological evidence","Evidence of UC extending ≥ 15 cm from the anal verge as assessed by colonoscopy. Moderately to severely active UC, defined as a modified Mayo Score of 5 to 9, with an Endoscopic Subscore ≥ 2","Documented failure to prior advanced therapies or prior conventional therapies","Female participants must meet either criterion a) or b), and male participants must meet criterion c) to be eligible for enrollment:","Female participants of non-childbearing potential;","Female participants of childbearing potential who are not pregnant must agree to use highly effective contraception during the treatment period and for at least 1 month after the last dose of study treatment;"],"whoShouldSkip":["Severe extensive colitis","Hospitalization for exacerbation of UC within 12 weeks prior to screening","History of gastrointestinal dysplasia, or presence of dysplasia detected in any biopsy performed during the screening colonoscopy","Adenomatous colonic polyps that have not been removed prior to study enrollment","Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or Crohn's disease, or clinical findings suggestive of Crohn's disease","Positive stool pathogen test or positive test for Clostridioides difficile toxin at screening","Presence of an ostomy or fistula"],"whatHappens":"If you join, the listed intervention(s) are AC-101, AC-101, or Placebo. The registry lists allocation as randomized. This is a Phase Ⅱb, multicenter, randomly assigned, parallel-group, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 153 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.221Z"},{"nctId":"NCT07755410","title":"A Study to Evaluate Safety and Efficacy of ALKS 7290 Compared With Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder (ALKS 7290-201)","officialTitle":"A Phase 2, Randomized, Parallel-Group, Double-Blind, Study to Evaluate the Safety and Efficacy of ALKS 7290 Compared to Placebo in Adult Participants With Attention Deficit Hyperactivity Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Alkermes, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with placebo tablets.","conditions":["Attention Deficit Disorder With Hyperactivity (ADHD)"],"keywords":["ADHD","Attention Deficit Disorder with Hyperactivity"],"interventions":[{"type":"DRUG","name":"ALKS 7290"},{"type":"DRUG","name":"Placebo"}],"enrollment":312,"startDate":"2026-08-10","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2.\n* Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose.\n* AISRS total score of ≥26\n* CGI-S score ≥ 4 (moderately ill or worse)\n* Has a Body Mass Index within 18 to 35 kg/m2\n\nExclusion Criteria:\n\n* Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation.\n* Has any of the following psychiatric conditions per the DSM-5 criteria, as assessed by the MINI. Conditions not assessable by the MINI should be assessed by clinical judgement; Diagnosis of schizophrenia, schizoaffective disorder, or bipolar I or II disorder, or current, unstable, MDD or GAD.\n* Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study.\n* Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance.\n* Any other psychiatric condition that could interfere with participation in the study.","locations":[{"facility":"Alkermes Investigational Site","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigator Site","city":"Chino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Clermont","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Largo","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigator Site","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Orange City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Foxborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Watertown","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Memphis","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Lincoln","state":"Nebraska","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"North Canton","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"East Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"The Woodlands","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alkermes Investigational Site","city":"Bellevue","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Global Clinical Services","phone":"888-235-8008 (US Only)","email":"clinicaltrials@alkermes.com"},{"name":"Global Clinical Services","phone":"571-599-2702 (Global)","email":"clinicaltrials@alkermes.com"}],"primaryOutcomes":["Change from Baseline to Week 4 in Attention Deficit Disorder Investigator Symptom Rating Scale (AISRS) total score"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas","chino-california","clermont-florida","jacksonville-florida","lakeland-florida","largo-florida","maitland-florida","orange-city-florida","orlando-florida","tampa-florida","decatur-georgia","foxborough-massachusetts","watertown-massachusetts","detroit-michigan","memphis-michigan","lincoln-nebraska","las-vegas-nevada","north-canton-ohio","east-providence-rhode-island","north-charleston-south-carolina","austin-texas","the-woodlands-texas","bellevue-washington"],"enrichment":{"headline":"Phase 2: testing ALKS 7290 for Attention Deficit Disorder With Hyperactivity (ADHD)","inPlainEnglish":"This study wants to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with dummy treatment (placebo) tablets.","whoItsFor":["Ages 18 Years to 65 Years","Meets the Diagnostic and Statistical Manual of Mental Disorders -5 criteria for ADHD, as confirmed by the Mini-International Neuropsychiatric Interview (MINI) for ADHD Studies 7.0.2","Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. Participants must be stable on permitted medication for 2 months prior to first visit, without anticipated changes to dose","AISRS total score of ≥26","CGI-S score ≥ 4 (moderately ill or worse)","Has a Body Mass Index within 18 to 35 kg/m2"],"whoShouldSkip":["Has a known history of intellectual developmental disorder or cognitive impairment that, in the opinion of the Investigator, would interfere with study participation","Clinically significant cognitive difficulties including dementia, delirium or amnestic syndromes, or any other cognitive disorder present with the past 2 years that could interfere with participation in the study","Moderate to severe substance use disorder according to DSM-5 guidelines, including use of alcohol, nicotine, cannabis, narcotics, or any illicit substance","Any other psychiatric condition that could interfere with participation in the study"],"whatHappens":"If you join, the listed intervention(s) are ALKS 7290, or Placebo. The registry lists allocation as randomized. This study wants to measure safety and the improvement in symptoms in subjects with ADHD when taking ALKS 7290 tablets compared with dummy treatment (placebo) tablets.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 312 people at 25 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.648Z"},{"nctId":"NCT07755956","title":"Phase Ia Trial of HHK001 Compared With Enantone in Patients With Endometriosis","officialTitle":"A Phase Ia Clinical Trial to Compare Pharmacokinetics, Pharmacodynamics, Safety and Preliminary Efficacy of HHK001 Versus Enantone in Patients With Endometriosis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate. We will check how the body absorbs and responds to each medicine, monitor possible side effects and treatment benefits.\n\nResearchers will compare HHK001 to Enantone to test the advantages of its updated formulation.","conditions":["Endometriosis"],"keywords":["leuprorelin","pharmacokinetics","pharmacodynamics","endometriosis"],"interventions":[{"type":"DRUG","name":"HHK001"},{"type":"DRUG","name":"Enantone"}],"enrollment":20,"startDate":"2026-10-31","completionDate":"2027-03-31","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily provide written informed consent;\n* Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;\n* The most recent menstrual cycle 21-35 days;\n* Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;\n* Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;\n* No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing.\n\nExclusion Criteria:\n\n* Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;\n* With contraindications to rescue medication (ibuprofen);\n* Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;\n* Received any GnRH agonist/antagonist within 12 weeks before screening;\n* Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;\n* History of miscarriage within 4 weeks before screening;\n* History of alcohol dependence, drug abuse or illicit substance use;\n* Other conditions unsuitable for the trial judged by the investigator.","locations":[{"facility":"The Third Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suzhou Municipal Hospital (The Affiliated Suzhou Hospital of Nanjing Medical University)","city":"Suzhou","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liang Li","phone":"+86 15800440760","email":"liliang@hhkmed.cn"}],"primaryOutcomes":["Concentrations of leuprorelin acetate","Concentrations of estradiol"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["changsha-china","suzhou-china"],"enrichment":{"headline":"Phase 1: testing HHK001 for Endometriosis","inPlainEnglish":"The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis. Both products contain the same active ingredient: leuprorelin acetate.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Female, aged 18-45 years, weight ≥ 40 kg, body mass index 19-28 kg/m²;","The most recent menstrual cycle 21-35 days;","Confirmed diagnosis of endometriosis, and suitable for GnRH agonist;","Cervical cytology test result showing No Intraepithelial Lesion or Malignancy;","No plan for pregnancy, egg cryopreservation or donation, and agree to use effective contraception from screening through 3 months after dosing"],"whoShouldSkip":["Allergic to GnRH agonists/antagonists, or history of allergies to ≥3 different substances, or active allergic disease;","With contraindications to rescue medication (ibuprofen);","Current or past medical history of osteoporosis/osteopenia, pituitary tumor, epilepsy, depressive disorder, thromboembolic events, malignant tumors, unexplained abnormal uterine bleeding;","Received any GnRH agonist/antagonist within 12 weeks before screening;","Received medications that may significantly alter hypothalamic-pituitary-gonadal axis hormone levels within 4 weeks before screening;","History of miscarriage within 4 weeks before screening;","History of alcohol dependence, drug abuse or illicit substance use;"],"whatHappens":"If you join, the listed intervention(s) are HHK001, or Enantone. The registry lists allocation as randomized. The goal of this clinical trial is to find out how the study drug HHK001 compares to Enantone (an approved treatment for endometriosis) when given as a single 3.75 mg injection to participants with endometriosis.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.108Z"},{"nctId":"NCT07756736","title":"Psilocybin Therapy for Methamphetamine Use Disorder and HIV","officialTitle":"Psilocybin Recovery Intervention for Stopping Methamphetamine Use","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Nicky Mehtani, MD, MPH","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are:\n\n* Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?\n* Is psilocybin safe and tolerable among people with HIV and MeUD?\n\nParticipants will:\n\n* Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin\n* Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session.\n* Report their methamphetamine use prior to, during, and up to 3 months following the intervention\n* Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible","conditions":["Methamphetamine Use Disorder","Human Immunodeficiency Virus (HIV)"],"keywords":["methamphetamine use disorder","HIV","methamphetamine","psilocybin","amphetamine-related disorders","stimulant use disorder","people with HIV","psychedelics","psychedelic-assisted therapy"],"interventions":[{"type":"DRUG","name":"Psilocybin 5 mg"},{"type":"DRUG","name":"Psilocybin 25 mg"},{"type":"BEHAVIORAL","name":"Motivational Support"}],"enrollment":30,"startDate":"2026-12","completionDate":"2029-04","sex":"ALL","minAge":"25 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 25 to 64\n* Diagnosed with HIV at least 3 months ago\n* Moderate-to-severe methamphetamine use disorder\n* Uses methamphetamine regularly and identifies it as their primary drug\n* Has a goal of quitting methamphetamine use\n* Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions\n* Currently living indoors with stable housing anticipated for the duration of the study\n* Has a text-capable cellphone\n* Willing to use highly effective contraception and not donate sperm throughout the study\n* Able to participate in study procedures in English\n\nExclusion Criteria:\n\n* History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment\n* Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)\n* Currently taking certain medications that may interact with psilocybin\n* Recent use of a psychedelic drug\n* Certain significant heart, liver, or kidney conditions\n* Uncontrolled high blood presure (i.e., \\>150/90 mmHg)\n* History of stroke or seizure in the past year\n* Current pregnancy or breastfeeding\n* Current involvement in the criminal legal system that would be expected to interfere with study participation\n* Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month\n\nNote: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.","locations":[{"facility":"UCSF at Zuckerberg San Francisco General Hospital","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eliza Banbury, BA","phone":"510-985-3522","email":"prism.trial@ucsf.edu"}],"primaryOutcomes":["Recruitment Efficiency","Dosing Completion","Retention","Acceptability","Adverse Events"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["psilocybin"],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Phase 2: testing Psilocybin 5 mg for Methamphetamine Use Disorder","inPlainEnglish":"The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are: * Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?","whoItsFor":["Ages 25 Years to 64 Years","Diagnosed with HIV at least 3 months ago","Moderate-to-severe methamphetamine use disorder","Uses methamphetamine regularly and identifies it as their primary drug","Has a goal of quitting methamphetamine use","Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions","Currently living indoors with stable housing anticipated for the duration of the study","Has a text-capable cellphone"],"whoShouldSkip":["History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment","Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)","Currently taking certain medications that may interact with psilocybin","Recent use of a psychedelic drug","Certain significant heart, liver, or kidney conditions","Uncontrolled high blood presure (i.e., \\>150/90 mmHg)","History of stroke or seizure in the past year"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin 5 mg, Psilocybin 25 mg, or Motivational Support. The registry lists allocation as randomized. The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at San Francisco. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.528Z"},{"nctId":"NCT07757880","title":"Randomized Evaluation of Operating Room Extubation After Cardiac Surgery","officialTitle":"Randomized Evaluation of Operating Room Extubation Versus Intensive Care Unit Extubation After Cardiac Surgery","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Massachusetts General Hospital","sponsorClass":"OTHER","summary":"We are studying whether waking patients up and removing the breathing tube (also known as \"extubation\") in the operating room after cardiac surgery improves postoperative recovery without causing harm.","conditions":["Cardiac Surgery"],"keywords":["Extubation","Cardiac surgery","Cardiac surgery recovery"],"interventions":[{"type":"PROCEDURE","name":"OR extubation"},{"type":"PROCEDURE","name":"ICU extubation"}],"enrollment":120,"startDate":"2026-11-09","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass\n* Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator\n* Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Underlying pulmonary disease requiring use of home supplemental oxygen\n* Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR \\> 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation\n* Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram\n* BMI ≥ 35\n* Obstructive sleep apnea with home CPAP or biPAP use or recommended use\n* Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy\n* Airway abnormalities including tracheostomy, history of difficult mask ventilation, history of difficult intubation requiring fiberoptic rescue or multiple (\\>2) attempts, known anatomic abnormalities including limited mouth opening (\\< 3cm), severe micrognathia, tracheal stenosis, or tracheal compression due to mass or goiter\n\nWe will also exclude patients undergoing the following procedures:\n\n* Transplant surgery\n* Pulmonary thromboendarterectomy\n* Implantation of mechanical circulatory support including LVAD, Impella, intra-aortic balloon pump, RVAD, or ECMO","locations":[{"facility":"Massachusetts General Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lauren Gibson, MD","phone":"617-726-3030","email":"legibson@mgh.harvard.edu"},{"name":"Jordan Bloom, MD, MPH","phone":"617-643-6058","email":"jpbloom@mgh.harvard.edu"}],"primaryOutcomes":["Hierarchical composite endpoint, ordered by clinical priority"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: OR extubation for Cardiac Surgery","inPlainEnglish":"We are studying whether waking patients up and removing the breathing tube (also known as \"extubation\") in the operating room after cardiac surgery improves postoperative recovery without causing harm.","whoItsFor":["Ages 18 Years to any","Adults (age 18+) scheduled for elective cardiac surgery requiring cardiopulmonary bypass","Low perioperative risk defined as STS Predicted Risk of Mortality (PROM) ≤ 3% based on the latest STS Adult Cardiac Surgery Database (ACSD) Risk Calculator","Deemed appropriate for OR extubation preoperatively by the attending cardiac surgeon"],"whoShouldSkip":["Underlying pulmonary disease requiring use of home supplemental oxygen","Pre-capillary pulmonary hypertension (mPAP ≥ 25 mmHg or PVR \\> 2 Wood units) on most recent right heart catheterization for any patient for which there is suspicion for pulmonary hypertension at the time of preoperative evaluation","Preoperative right ventricular dysfunction greater than mild on most recent echocardiogram","Obstructive sleep apnea with home CPAP or biPAP use or recommended use","Neuromuscular disease associated with respiratory muscle weakness including myasthenia gravis, Lambert-Eaton myasthenic syndrome, or muscular dystrophy","We will also exclude patients undergoing the following procedures:","Pulmonary thromboendarterectomy"],"whatHappens":"If you join, the listed intervention(s) are OR extubation, or ICU extubation. The registry lists allocation as randomized. We are studying whether waking patients up and removing the breathing tube (also known as \"extubation\") in the operating room after cardiac surgery improves postoperative recovery without causing harm.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 2 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.441Z"},{"nctId":"NCT07758270","title":"Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.","officialTitle":"REMIBRUTINIB: EVALUATION OF FLUID AND INFLAMMATORY NEUROIMAGING ENDPOINTS IN MULTIPLE SCLEROSIS (REDEFINE-MS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later. \\[REDEFINE\\_p...2026\\_clean \\| Word\\] The main question the study is trying to answer is whether remibrutinib changes immune activity and inflammation in people with MS, and whether these changes can be measured using imaging and biological markers that may help predict future disease progression and treatment response.","conditions":["Multiple Sclerosis (MS) - Relapsing-remitting"],"keywords":["Multiple Sclerosis, Relapsing Multiple Sclerosis and Neuroinflammation"],"interventions":[{"type":"DRUG","name":"Remibrutinib"},{"type":"DRUG","name":"Ocrelizumab (US)"}],"enrollment":15,"startDate":"2026-08-15","completionDate":"2029-08-15","sex":"ALL","minAge":"40 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Capable of providing written informed consent for volunteering to undergo research procedures.\n* Male or female, any race\n* Age between 40 and 70 years of age, inclusive\n* Diagnosis of RMS according to revised 2017 McDonald criteria at screening 15\n* EDSS score of 0 to 6.5 (inclusive) at screening\n* Treated with ocrelizumab according to routine clinical practice and at standard dose for at least 18 months. The last administration of ocrelizumab must have occurred within 5 to 9 months prior to randomization.\n* Neurologically stable within 30 days prior to screening, including no MS relapse during this period.\n* Suitable to be switched to remibrutinib based on physician judgement or patient preference.\n\nExclusion Criteria:\n\nThe exclusion criteria of the parent study are adapted and inherited under this section (See parent study protocol section 5.2). In addition, the following exclusion criteria apply:\n\n* Hypersensitivity to \\[11C\\]-DPA-713 or any of its excipients\n* Contraindications to PET or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate\n* Presence of a low affinity binding TSPO polymorphism.\n* Any condition that, in the opinion of the Principal Investigator or his designee, could increase the risk to the participant or limits their ability to participate (e.g., liver or kidney disease, advanced cancer)\n* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.","locations":[{"facility":"Washington University School of Medicine in St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nicole Shelley","phone":"314-362-7666","email":"nshelley@wustl.edu"},{"name":"Kelley M Jackson, BS","phone":"314-362-3613","email":"kelleyj@wustl.edu"}],"primaryOutcomes":["Change in Microglial Activity Measured by [11C]-DPA-713 PET"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: testing Remibrutinib for Multiple Sclerosis (MS) - Relapsing-remitting","inPlainEnglish":"REDEFINE-MS is a research study for people with relapsing multiple sclerosis (MS) who are participating in the RESHAPE-MS trial. The study aims to better understand how remibrutinib affects inflammation in the brain and spinal cord by using PET imaging, MRI scans, blood samples, and cerebrospinal fluid (CSF) samples collected before treatment and again six months later.","whoItsFor":["Ages 40 Years to 70 Years","Male or female, any race","Age between 40 and 70 years of age, inclusive","Diagnosis of RMS according to revised 2017 McDonald criteria at screening 15","EDSS score of 0 to 6.5 (inclusive) at screening","Treated with ocrelizumab according to routine clinical practice and at standard dose for at least 18 months. The last administration of ocrelizumab must have occurred within 5 to 9 months prior to randomization","Neurologically stable within 30 days prior to screening, including no MS relapse during this period","Suitable to be switched to remibrutinib based on physician judgement or patient preference"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 15 people at St Louis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.992Z"},{"nctId":"NCT07759128","title":"A Trial of the Efficacy and Safety of Fixed Doses of SEP-363856 in Adults With Generalized Anxiety Disorder","officialTitle":"A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of Fixed Doses of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsorClass":"INDUSTRY","summary":"This is a global, phase 3, randomized, double-blind, parallel-group, 3-arm, placebo-controlled, multicenter study designed to compare the efficacy, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \\[mg/day\\]) to placebo in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.","conditions":["Generalized Anxiety Disorder"],"keywords":["Generalized Anxiety Disorder","GAD","anxiety"],"interventions":[{"type":"DRUG","name":"SEP-363856"},{"type":"OTHER","name":"Placebo"}],"enrollment":576,"startDate":"2026-07-28","completionDate":"2028-12-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Male or female participants at least 18 years of age at the time of informed consent\n2. Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation\n3. Body Mass Index (BMI) between 18 and 40 kilograms per square meter (kg/m\\^2) (inclusive)\n4. Participant is willing and able to comply with study procedures and visit schedule\n5. Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests\n6. Willing and able to discontinue prohibited medications/therapies per protocol\n7. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions\n8. Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period.\n\nKey Exclusion Criteria:\n\n1. Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening\n2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening\n3. Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)\n4. Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \\[C-SSRS\\] or MADRS)\n5. Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)\n6. Prior exposure to restricted treatments\n7. Pregnant or breastfeeding females\n8. Participation in another investigational study within 180 days (or more than \\[\\>\\] 1 trial in last year)\n9. Known history of human immunodeficiency virus seropositivity, hepatitis B or C","locations":[{"facility":"Del Sol Research Management","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pharmacology Research Institute","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Neuroscience Research Medical Group, Inc","city":"Sherman Oaks","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emerson Clinical Research Institute - Washington, DC","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sarkis Clinical Trials - Gainesville","city":"Gainesville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - Maitland","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Conventions Research, Inc","city":"Warrenville","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Works, Inc","city":"New Orleans","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Boston","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vector Clinical Trials - Las Vegas","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Harlem","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manhattan Behavioral Medicine PLLC","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Insight Clinical Trials","city":"Independence","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sooner Clinical Research, Inc.","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"FutureSearch Trials of Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Dallas","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Otsuka Call Center","phone":"844-687-8522","email":"ProfessionalServices@otsuka-us.com"}],"primaryOutcomes":["Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["tucson-arizona","encino-california","sherman-oaks-california","washington-d-c-district-of-columbia","gainesville-florida","jacksonville-florida","maitland-florida","warrenville-illinois","new-orleans-louisiana","boston-massachusetts","las-vegas-nevada","new-york-new-york","independence-ohio","oklahoma-city-oklahoma","dallas-texas","desoto-texas"],"enrichment":{"headline":"Phase 3: testing SEP-363856 for Generalized Anxiety Disorder","inPlainEnglish":"This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 3-arm, compared with a dummy treatment, multicenter study designed to compare the how well it works, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \\[mg/day\\]) to dummy treatment (placebo) in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.","whoItsFor":["Ages 18 Years to any","Primary diagnosis of Generalized Anxiety Disorder (GAD) per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation","Body Mass Index (body-mass index (BMI)) between 18 and 40 kilograms per square meter (kg/m\\^2) (inclusive)","Participant is willing and able to comply with study procedures and visit schedule","Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests","Willing and able to discontinue prohibited medications/therapies per protocol","i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions","Participant is willing and able to safely discontinue all prohibited medications/therapies/herbal supplements in accordance with the protocol-required washouts prior to baseline/Day 1 and during the trial period"],"whoShouldSkip":["Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening","Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening","Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)","Significant suicide risk (e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \\[C-SSRS\\] or MADRS)","Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)","Prior exposure to restricted treatments","Pregnant or breastfeeding females"],"whatHappens":"If you join, the listed intervention(s) are SEP-363856, or Placebo. The registry lists allocation as randomized. This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 3-arm, compared with a dummy treatment, multicenter study designed to compare the how well it works, safety, and tolerability of fixed doses of SEP-363856 (50 and 75 milligrams per day \\[mg/day\\]) to dummy treatment (placebo) in adults at least 18 years of age with generalized anxiety disorder (GAD) over 8 weeks.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 576 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.350Z"},{"nctId":"NCT07759154","title":"A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation","officialTitle":"A Phase 3b, Multicenter, Open-label, Single-arm Trial to Evaluate the Efficacy and Safety of Orally Administered Centanafadine QD XR Capsules in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to evaluate the efficacy of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).","conditions":["Attention-deficit/Hyperactivity Disorder","Emotional Dysregulation"],"keywords":["ADHD","ED"],"interventions":[{"type":"DRUG","name":"Centanafadine XR"}],"enrollment":80,"startDate":"2026-09-01","completionDate":"2027-05-27","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Primary diagnosis of ADHD per the Adult ADHD Clinical Diagnostic Scale (ACDS).\n2. Adult ADHD Investigator Symptom Rating Scale (AISRS) total score of ≥ 28 at baseline.\n3. Symptoms of ED as determined by the WRAADDS-ED subscale score ≥ 7 at baseline.\n4. CGI-S-ADHD rating ≥ 4 (at least moderate severity) at baseline.\n\nExclusion Criteria\n\n1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a lifetime diagnosis of bipolar and related disorders, schizophrenia spectrum and other psychotic disorders, borderline and antisocial personality disorders, neurocognitive disorders, autism spectrum disorder, or intellectual disability.\n2. DSM-5 criteria for a current diagnosis of major depressive disorder, post-traumatic stress disorder, any substance use disorder, untreated/unstable obstructive sleep apnea, eating disorders, or obsessive compulsive disorder.\n3. Any other current DSM-5 comorbid psychiatric disorder identified by the Mini International Neuropsychiatric Interview (MINI) or any medical condition that, in the judgment of the investigator, could be expected to require treatment with medications prohibited in this trial that cannot be safely discontinued with completion of an appropriate washout, could confound efficacy or safety assessments, or be the primary driver of ED.\n4. Presence of an unstable or uncontrolled medical condition that, in the opinion of the investigator, could pose a safety risk to the participant or could manifest with psychiatric symptoms (eg, thyroid disease).\n5. In the clinical opinion of the investigator, the participant has not derived significant therapeutic benefit from 2 or more ADHD therapies of 2 different classes (eg, amphetamine and methylphenidate, or amphetamine and atomoxetine) given with an acceptable dose and duration during adulthood (aged 18 years or older).\n6. Current use of prohibited psychotropic medications that cannot be discontinued within 7 to 28 days prior to enrollment.\n7. Any disorder that is the primary focus of treatment other than ADHD.\n8. Evidence of current substance use disorder or history in the past 12 months.\n9. History of any prior exposure to centanafadine.\n10. Participated in other clinical trials involving investigational drugs within 180 days prior to screening or participated in more than 2 interventional clinical trials involving investigational drugs within the past year.\n11. 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The registry lists allocation as na. The primary purpose of this study is to measure the how well it works of centanafadine once daily (QD) extended-release (XR) capsules in adults with attention-deficit/hyperactivity disorder (ADHD) and emotional dysregulation (ED).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 80 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.643Z"},{"nctId":"NCT07759245","title":"A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","officialTitle":"A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.","conditions":["Pulmonary Disease, Chronic Obstructive"],"keywords":["Emphysema","Chronic Bronchitis","Lung Disease"],"interventions":[{"type":"DRUG","name":"Brenipatide"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of Care"}],"enrollment":606,"startDate":"2026-08-07","completionDate":"2028-05","sex":"ALL","minAge":"40 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)/forced vital capacity (FVC) less than (\\<) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"NewportNativeMD, Inc.","city":"Newport Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Institute of HealthCare Assessment d/b/a Apex Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Jewish Health Medical Center","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Millennium Medical Research - 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De C.V.","city":"Mérida","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Unidad Medica para la Salud Integral Interior A","city":"San Nicolás de los Garza","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medimanage Research","city":"Tlalpan","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Uniwersytecki Szpital Kliniczny w Białymstoku","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centrum Medyczne ,,All - Med'' Badania Kliniczne","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diamond Clinic","city":"Krakow","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Juan Bautista School of Medicine - Clinical Research Unit","city":"Caguas","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global Puerto Rico","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arensia Clinics S.R.L.","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Delta Health Care","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Anima Speciality Medical Services","city":"Bucharest","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic Judetean de Urgenta Cluj Napoca","city":"Cluj-Napoca","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic de Pneumoftiziologie \"Leon Daniello\" Cluj","city":"Cluj-Napoca","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul de Boli Infecțioase Victor Babeș","city":"Craiova","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spital de Pneumologie Dr. Lavinia Davidescu","city":"Oradea","state":"","country":"Romania","status":"RECRUITING","lat":null,"lon":null},{"facility":"Spitalul Clinic de Boli Infecţioase si Pneumoftiziologie Dr. Victor Babeş Timișoara","city":"Timișoara","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, Incheon St. Mary's Hospital","city":"Bupyeong-gu","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chung-Ang University Hospital","city":"Dongjak-gu","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yeungnam Univeristy Medical Center","city":"Gyeongsan-si","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea, Eunpyeong St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Konkuk University Medical Center","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic Univ. of Korea Seoul St. Mary's Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ulsan University Hospital","city":"Ulsan","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University-Wonju Severance Christian Hospital","city":"Wŏnju","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cheadle Community Hospital","city":"Cheadle","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Staploe Medical Centre","city":"Ely","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"HMC Health Group - Meadows Centre for Health","city":"Hounslow","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Queen Anne Street Medical Centre","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Atlantic Medical","city":"Penzance","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marine Lake Medical Practice","city":"West Kirby","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Change from Baseline in Pre-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","newport-beach-california","san-diego-california","denver-colorado","miami-florida","miami-lakes-florida","orlando-florida","westchester-illinois","indianapolis-indiana","muncie-indiana","boston-massachusetts","southfield-michigan","maplewood-minnesota","dubois-pennsylvania","denison-texas","houston-texas","lewisville-texas","kirkland-washington","buenos-aires-argentina","mendoza-argentina","r-o-cuarto-argentina","santa-rosa-argentina","feldbach-austria","klagenfurt-austria","linz-austria","vienna-austria","ajax-canada","kelowna-canada","sherbrooke-canada","trois-rivi-res-canada","windsor-canada","baotou-china","beijing-china","chengdu-china","guangzhou-china","jiangyin-china","jinan-china","pingxiang-china","shanghai-china","shenzhen-china","tianjin-china","xian-china","xinxiang-china","jindichv-hradec-czechia","miroslav-czechia","ostrava-czechia","prague-czechia","aalborg-denmark","copenhagen-denmark","hvidovre-denmark","roskilde-denmark","vejle-denmark","brest-france","cholet-france","cr-teil-france","la-tronche-france","lyon-france","marseille-france","montpellier-france","paris-france","pessac-france","toulouse-france","vand-uvre-l-s-nancy-france","frankfurt-germany","hamburg-germany","landsberg-am-lech-germany","leipzig-germany","mainz-germany","rheine-germany","budapest-hungary","edel-ny-hungary","g-d-ll-hungary","p-cs-hungary","ahmedabad-india","allahab-d-india","bangalore-india","bhopal-india","chhatrapati-sambhajinagar-india","lucknow-india","nagpur-india","new-delhi-india","noida-india","pune-india","udaipur-india","ch-ku-japan","fukuoka-japan","iizuka-japan","osaka-japan","sendai-japan","ube-japan","chihuahua-city-mexico","m-rida-mexico","san-nicol-s-de-los-garza-mexico","tlalpan-mexico","bialystok-poland","krakow-poland","caguas-puerto-rico","san-juan-puerto-rico","bucharest-romania","cluj-napoca-romania","craiova-romania","oradea-romania","timi-oara-romania","bupyeong-gu-south-korea","dongjak-gu-south-korea","gyeongsan-si-south-korea","seoul-south-korea","ulsan-south-korea","w-nju-south-korea","cheadle-united-kingdom","ely-united-kingdom","hounslow-united-kingdom","london-united-kingdom","penzance-united-kingdom","west-kirby-united-kingdom"],"enrichment":{"headline":"Phase 2: testing Brenipatide for Pulmonary Disease, Chronic Obstructive","inPlainEnglish":"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with dummy treatment (placebo). The study will last approximately one year.","whoItsFor":["Ages 40 Years to 75 Years","Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:","Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years","Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)/forced vital capacity (FVC) less than (\\<) 70 percent (%)","Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2","Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion","Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening"],"whoShouldSkip":["Have a known pre-existing, clinically important lung condition other than COPD","Have a current or recent acute, active infection before screening and up to randomization"],"whatHappens":"If you join, the listed intervention(s) are Brenipatide, Placebo, or Standard of Care. The registry lists allocation as randomized. The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with dummy treatment (placebo).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 606 people at 127 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.656Z"},{"nctId":"NCT07761910","title":"Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)","officialTitle":"Prospective Study on Radiation Induced Cardiotoxicity Assessed By PET-CT for Locally Advanced Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Indiana University","sponsorClass":"OTHER","summary":"Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).","conditions":["Non Small Cell Lung Cancer","Cardiotoxicity","Locally Advanced Non-Small Cell Lung Cancer","Radiation Therapy"],"keywords":["PET-CT","Radiation Injury","locally advanced Non-Small Cell Lung Cancer","Cardiotoxicity"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"PET/CT 18F-Flurpiridaz Rest/Stress Test"},{"type":"DEVICE","name":"Coronary CT Angiography (CCTA)"},{"type":"DRUG","name":"18F-Flurpiridaz"}],"enrollment":10,"startDate":"2027-01","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 at time of consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT.\n4. To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines.\n5. Tumor estimated to be within 2cm of heart contour or anticipated MHD\\>10Gy per treating physician.\n\nExclusion Criteria:\n\n1. Patients treated with stereotactic body radiotherapy (SBRT).\n2. Prior thoracic radiotherapy.\n\nExclusion for Coronary computed tomography angiography (CCTA)\n\n1. History of a severe anaphylactic reaction to iodinated contrast.\n2. Renal insufficiency (defined as estimated CrCl less than 30 mL/min).\n3. Inability to hold breath for more than 5 seconds.\n4. Patients on radioactive iodine therapy.\n\nExclusion for 18F-Flurpiridaz PET/CT Test\n\n1. Second-degree AV block, third-degree AV block, and sinus node disease (such as sick sinus syndrome or symptomatic bradycardia) without a functioning pacemaker.\n\n   Note: Resting 12-lead EKG will be ordered at the time of enrollment to be performed prior to PET/CT stress test.\n2. Patients with bronchospastic diseases including asthma and chronic obstructive pulmonary disease (COPD) who have an acute exacerbation or active wheezing (a high-pitched, musical, adventitious lung sound produced by airflow through the narrowed airways) on the day of PET CT exam.\n3. Patients who are hypotensive (systolic blood pressure less than 90 mm Hg) on the day of the PET/CT scan.","locations":[{"facility":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica Anders","phone":"1 317-278-2722","email":"jemlynn@iu.edu"}],"primaryOutcomes":["Change of MBF (myocardial blood flow)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["indianapolis-indiana"],"enrichment":{"headline":"Phase 2: testing 18F-Flurpiridaz for Non Small Cell Lung Cancer","inPlainEnglish":"Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).","whoItsFor":["Ages 18 Years to any","Age ≥ 18 at time of consent","Stage III NSCLC per AJCC 8th edition guideline, confirmed by pathological diagnosis and PET/CT","To receive standard definitive concurrent chemoradiation therapy per NCCN guidelines","Tumor estimated to be within 2cm of heart contour or anticipated MHD\\>10Gy per treating physician"],"whoShouldSkip":["Patients treated with stereotactic body radiotherapy (SBRT)","Prior thoracic radiotherapy","Exclusion for Coronary computed tomography angiography (CCTA)","History of a severe anaphylactic reaction to iodinated contrast","Renal insufficiency (defined as estimated CrCl less than 30 mL/min)","Inability to hold breath for more than 5 seconds","Patients on radioactive iodine therapy"],"whatHappens":"If you join, the listed intervention(s) are PET/CT 18F-Flurpiridaz Rest/Stress Test, Coronary CT Angiography (CCTA), or 18F-Flurpiridaz. The registry lists allocation as na. Prospective clinical study designed to evaluate damage to the heart after receiving standard of care chemotherapy and radiation therapy for locally advanced Non-Small Cell Lung Cancer (NSCLC).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 10 people at Indianapolis. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.715Z"},{"nctId":"NCT07762092","title":"A Post Authorization Registry Study of Participants Treated With LEQEMBI","officialTitle":"Post Authorization Registry Study of Patients Treated With LEQEMBI","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eisai Limited","sponsorClass":"INDUSTRY","summary":"To describe the incidence and severity of known adverse events, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \\[CAA\\]).\n\nThe secondary purpose of this study is,\n\nTo describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.\n\nTo describe previously unknown adverse events related to the long-term safety of LEQEMBI in routine clinical practice, which were not identified in clinical development, as assessed by serious suspected adverse reactions, adverse reactions leading to discontinuation of LEQEMBI treatment, and deaths that occur within 30 days of discontinuation of LEQEMBI treatment (regardless of causality).\n\nTo describe drug utilization of LEQEMBI and to assess the effectiveness of risk minimization measures in routine clinical practice.","conditions":["Alzheimers Disease"],"keywords":["Alzheimer's Disease","Early Alzheimer's Disease","LEQEMBI","ARIA"],"interventions":[{"type":"OTHER","name":"No Intervention"}],"enrollment":400,"startDate":"2026-07-30","completionDate":"2036-04-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada.\n\nExclusion Criteria:\n\n* None","locations":[{"facility":"University of Calgary - Hotchkiss Brain Institute","city":"Calgary","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Alberta, Geriatric Division","city":"Edmonton","state":"Alberta","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of British Columbia - CARD","city":"Vancouver","state":"British Columbia","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UBC Victoria - Neil and Susan Manning Cognitive Health Initiative","city":"Victoria","state":"British Columbia","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kingston HHC (Queen University)","city":"Kingston","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Parkwood Hospital - London","city":"London","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Trillium Hospital","city":"Mississauga","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bruyère Institute","city":"Ottawa","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kawartha Center","city":"Peterborough","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunnybrook Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Toronto Memory Program","city":"Toronto","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Toronto Western Hospital","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinique Neuro-Outaouais","city":"Gatineau","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"MOCA","city":"Greenfield Park","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"IUGM","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"McGill University, Douglas Mental Health","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Québec-Université Laval Research Center","city":"Québec","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eisai Medical Information","phone":"+1-888-274-2378","email":"esi_medinfo@eisai.com"}],"primaryOutcomes":["Incidence and Severity of Known AEs"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["calgary-canada","edmonton-canada","vancouver-canada","victoria-canada","kingston-canada","london-canada","mississauga-canada","ottawa-canada","peterborough-canada","toronto-canada","gatineau-canada","greenfield-park-canada","montreal-canada","qu-bec-canada"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention for Alzheimers Disease","inPlainEnglish":"To describe the incidence and severity of known side effects, including amyloid-related imaging abnormalities-edema (ARIA-E), ARIA microhemorrhage and hemosiderin deposit (ARIA-H), and intracerebral hemorrhage greater than 1 cm in diameter in participants treated with LEQEMBI during routine clinical practice, summarizing the data overall and by apolipoprotein E4 variant (APOE4) genotype, concomitant antithrombotic therapy, and baseline magnetic resonance imaging (MRI) findings (comorbid cerebral amyloid angiopathy \\[CAA\\]). The secondary purpose of this study is, To describe progression to the next stage of Alzheimer's Disease (AD), stratified by ARIA and intracerebral hemorrhage greater than 1 cm.","whoItsFor":["Participants with Alzheimer's Disease who are prescribed LEQEMBI in Canada"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at 17 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.330Z"},{"nctId":"NCT07762560","title":"Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock","officialTitle":"Routine Microaxial Flow Pump Versus Radial Access Revascularization Without Routine Microaxial Flow Pump in Infarct-Related Cardiogenic Shock & Routine Pulmonary Artery Catheterization-based Monitoring With Protocolized Hemodynamic Optimization Versus Simplified Monitoring Without Protocolized Hemodynamic Optimization in Infarct-Related Cardiogenic Shock","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"NONE","sponsor":"Leipzig Heart Science gGmbH","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).\n\nThe main questions it aims to answer are:\n\n* Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?\n* Does protocol-based hemodynamic monitoring and optimization using a pulmonary artery catheter (PAC) improve survival compared to conventional intensive care monitoring?\n\nResearchers will compare four treatment combinations to see if mechanical circulatory support and/or advanced hemodynamic monitoring reduce mortality in AMI-CS patients:\n\n* Microaxial flow pump + pulmonary artery catheter\n* Microaxial flow pump + conventional monitoring\n* Medical therapy alone + pulmonary artery catheter\n* Medical therapy alone + conventional monitoring\n\nParticipants will:\n\n* Undergo immediate coronary angiography and PCI upon hospital admission Be randomly assigned to one of four treatment groups\n* Receive either immediate implantation of a microaxial flow pump or initial medical therapy with vasoactive agents following PCI\n* Be monitored either via pulmonary artery catheter with protocol-based hemodynamic optimization or via conventional intensive care monitoring\n* Be followed up at 30 days, 6 months and 12 monthsafter Randomization, with planned annual follow-up assessments for up to 10 years","conditions":["Cardiogenic Shock","Acute Myocardial Infarction (AMI)","Heart Failure, Acute"],"keywords":["2x2 factorial design","Mortality","Intensive care","Percutaneous coronary intervention","Hemodynamic monitoring","Mechanical circulatory support","Impella","Microaxial flow pump","AMI-CS","Acute myocardial infarction","Cardiogenic shock"],"interventions":[{"type":"DEVICE","name":"Microaxial flow pump (left ventricular assist device)"},{"type":"DEVICE","name":"Pulmonary artery catheter"},{"type":"PROCEDURE","name":"Conventional hemodynamic monitoring"},{"type":"PROCEDURE","name":"Hemodynamic stabilization"}],"enrollment":780,"startDate":"2026-10-31","completionDate":"2030-10","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nCardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:\n\n1. Planned immediate angiography and revascularization (preferred PCI)\n2. Systolic blood pressure \\<100 mmHg or catecholamines required to maintain pressure \\>90 mmHg during systole\n3. Arterial lactate \\>2.0 mmol/L\n4. Echocardiogram with LVEF \\<40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm\n\nExclusion Criteria:\n\n1. Age \\<18 and \\>80 years\n2. Shock duration \\>12 hours\n3. Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis).\n4. Shock due to mechanical complication of AMI\n5. Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \\>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \\<10 min are also eligible)\n6. After 390 included patients with OHCA, any OHCA will be an exclusion criterion\n7. Any unwitnessed OHCA\n8. Refractory cardiac arrest with ongoing chest compression\n9. Evidence of severe right ventricular failure\n10. Severe aorta valve regurgitation/stenosis\n11. Severe peripheral arterial obstructive disease precluding mAFP placement\n12. Abnormalities of the aorta precluding mAFP device placement\n13. Presence of a mechanical aortic valve prosthesis\n14. Left ventricular thrombus\n15. Infective endocarditis\n16. Life expectancy \\<1 year due to comorbidities\n17. Mental disorder or language barrier that preclude informed consent\n18. Known pregnancy","locations":[{"facility":"Heart Center Leipzig at University of Leipzig","city":"Leipzig","state":"Saxony","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"DOUBLE SHOCK Leipzig Heart Science gGmbH","phone":"+49 341 865 251542","email":"DOUBLE-SHOCK@leipzig-heart.de"}],"primaryOutcomes":["all-cause death"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["leipzig-germany"],"enrichment":{"headline":"Not a traditional drug phase: Microaxial flow pump (left ventricular assist device) for Cardiogenic Shock","inPlainEnglish":"The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS). The main questions it aims to answer are: * Does the immediate use of a left-sided microaxial flow pump (Impella) after percutaneous coronary intervention (PCI) improve survival compared to initial medical therapy alone?","whoItsFor":["Ages 18 Years to 80 Years","Cardiogenic shock complicating AMI (STEMI or NSTEMI) plus obligatory all 4 of these:","Planned immediate angiography and revascularization (preferred PCI)","Systolic blood pressure \\<100 mmHg or catecholamines required to maintain pressure \\>90 mmHg during systole","Arterial lactate \\>2.0 mmol/L","Echocardiogram with LVEF \\<40% or left ventricular outflow tract velocity time integral (LVOT-VTI) ≤12 cm"],"whoShouldSkip":["Age \\<18 and \\>80 years","Shock duration \\>12 hours","Other causes of shock (hypovolemia, sepsis, pulmonary embolism or anaphylaxis)","Shock due to mechanical complication of AMI","Witnessed out-of-hospital cardiac arrest (OHCA) with chest compression \\>10 min in total (cardiac arrest occurring in ambulance or after hospital arrival is NOT an exclusion criterion and witnessed OHCA with duration of chest compression \\<10 min are also eligible)","After 390 included patients with OHCA, any OHCA will be an exclusion criterion","Any unwitnessed OHCA"],"whatHappens":"If you join, the listed intervention(s) are Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, or Conventional hemodynamic monitoring. The registry lists allocation as randomized. The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 780 people at Leipzig. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.429Z"},{"nctId":"NCT07764328","title":"This Study Aims to Evaluate Whether Milamend's Product Could Improve Hormone Balance in Women Who Suffer From Self-reported PCOS Symptoms.","officialTitle":"A Randomized, Double-blind, Placebo-controlled Study Evaluating the Impact of Milamend on Quality of Life and Hormonal Health in Women With Self-Reported Symptoms Associated With Polycystic Ovary Syndrome (PCOS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Mila Mend Inc.","sponsorClass":"INDUSTRY","summary":"The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with Polycystic Ovarian Syndrome (PCOS). Additionally, the study aims to observe the impact of the product on menstrual cycle structure and associated symptoms, on reproductive and metabolic markers, on body image concerns, anxiety and general well-being. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this product in this population.\n\nWe will examine the outcomes in a broad age-range of premenopausal women who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home blood specimen collection. There is no \"doctor-patient\" relationship as part of this research since the participant as a consumer is making the informed choice to try the product and take part in the observational process with self-reported measures, cycle tracking and at-home blood sample collection. Findings from this study will contribute knowledge toward the tolerability and formulation of the product and the design of future studies.","conditions":["Polycystic Ovarian Syndrome (PCOS)"],"keywords":["Polycystic Ovarian Syndrome","PCOS","Quality of Life","Hormonal Health","Oligomenorrhea","hyperandrogenism"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"A dietary supplement powder for women"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":225,"startDate":"2025-12-23","completionDate":"2026-10-27","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Females between 18-40 years old, inclusive\n2. Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:\n3. Oligomenorrhea (\\<9 menstrual cycles in the past year)\n4. Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)\n5. Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year\n6. BMI of 18.5-35\n7. Owns or is willing to purchase a personal digital weight scale for monthly weight measurement.\n8. In good general health at the time of screening (Investigator discretion).\n9. Able to read and understand English.\n10. Able to read, understand, and provide informed consent.\n11. Able to use a personal smartphone device and download Chloe by People Science.\n12. Able to receive shipment of the product at an address within the United States.\n13. Able to complete study assessments over the course of up to 16 weeks.\n\nExclusion Criteria:\n\nAny potential participants who:\n\n1. Do not have a personal smartphone, internet access, or unwilling to download Chloe.\n2. Rates the impact of PCOS on their overall quality of life as \"Rarely/Seldom\" or \"Not at all\"\n3. Average cycle length of last 3 cycles is \\>50 days\n4. Concomitant Therapies:\n\n   1. Use of hormonal contraceptives within the last 6 months.\n   2. Use of a Co-Q10 supplement within the last 6 months.\n   3. Use of any high dose vitamin B supplements in the last 6 months.\n   4. Received any investigational therapies or treatments within 30 days prior to randomization.\n   5. Use of any other alpha-inositol/myo-inositol supplement in the last 6 months.\n   6. Pioglitazone, spironolactone or metformin in the previous 6 months.\n5. Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:\n6. Perimenopausal or menopausal.\n7. Participants diagnosed with Diabetes Mellitus (DM) for both Type I and Type II, who are managed with Insulin, Thiazolidinediones (TZDs) or Metformin.\n8. Known diagnosis of other causes of oligomenorrhea (e.g. thyroid disease, primary ovarian insufficiency, hyperprolactinemia, Cushing syndrome, any disorders of sexual development or Obesity).\n9. Chronic hepatic, renal, or cardiovascular disease (excluding hypertension).\n10. Known disorders that would affect nutrient absorption (e.g., Crohn's Disease, ulcerative colitis, chronic diarrhea, Celiac Disease, Irritable Bowel Syndrome, eating disorder).\n11. Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding\n12. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.\n13. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.\n14. Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.\n15. Other possible causes of oligomenorrhea such as history of disordered eating, chronic jetlag or shiftwork\n16. Known hypersensitivity or previous allergic reaction to the product ingredients: Vitamin B6 (as Pyridoxal-5-Phosphate), Folate (as L-5-Methyltetrahydrofolate Calcium), Zinc (as Zinc Picolinate), Selenium (as L-Selenomethionine), Chromium (as Chromium Picolinate), Myo-inositol, D-chiro-inositol, Co-enzyme Q10, Alpha Lipoic Acid, L-Glutamine, L-Carnitine Tartrate, L-Lysine (as L-Lysine HCl), L-Threonine, L-Tryptophan, beet root powder, hibiscus, or spirulina (algae) or citric acid.\n17. Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.","locations":[{"facility":"People Science, Inc.","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Noah Craft, M.D., Ph.D","phone":"213-328-0919","email":"noah@peoplescience.health"},{"name":"Crisel Erfe, M.D","phone":"310-922-0609","email":"crisel@peoplescience.health"}],"primaryOutcomes":["Quality of Life Impact"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["los-angeles-california"],"enrichment":{"headline":"Not a traditional drug phase: A dietary supplement powder for women for Polycystic Ovarian Syndrome (PCOS)","inPlainEnglish":"The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with Polycystic Ovarian Syndrome (PCOS). Additionally, the study aims to observe the impact of the product on menstrual cycle structure and associated symptoms, on reproductive and metabolic markers, on body image concerns, anxiety and general well-being.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Females between 18-40 years old, inclusive","Known diagnosis of Polycystic Ovarian Syndrome (PCOS) OR likely have PCOS as defined by presence of:","Oligomenorrhea (\\<9 menstrual cycles in the past year)","Signs of hyperandrogenism (hirsutism, acne, female-pattern hair loss)","Has recorded menstrual cycle duration of at least 3 menstrual cycles in the past year","Owns or is willing to purchase a personal digital weight scale for monthly weight measurement","In good general health at the time of screening (Investigator discretion)"],"whoShouldSkip":["Any potential participants who:","Do not have a personal smartphone, internet access, or unwilling to download Chloe","Rates the impact of PCOS on their overall quality of life as \"Rarely/Seldom\" or \"Not at all\"","Average cycle length of last 3 cycles is \\>50 days","Concomitant Therapies:","Use of hormonal contraceptives within the last 6 months","Use of a Co-Q10 supplement within the last 6 months"],"whatHappens":"If you join, the listed intervention(s) are A dietary supplement powder for women, or Placebo. The registry lists allocation as randomized. The rationale for this study is to observe the impact of a consumer-grade commercially available product called Milamend Hormone Balance on quality of life and hormonal health in women with self-reported symptoms associated with Polycystic Ovarian Syndrome (PCOS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 225 people at Los Angeles. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.793Z"},{"nctId":"NCT07764536","title":"Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool","officialTitle":"Augmenting Parent Management Training With Naturalistic Skills for Child Temper Outbursts Using a Digital Tool","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Mental Health (NIMH)","sponsorClass":"NIH","summary":"Background:\n\nPediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT). PMT teaches parents how to reward desired behaviors and not to reward undesired ones. Researchers want to find out if a smartphone app can help parents apply these skills more effectively.\n\nObjective:\n\nTo test a smartphone app to enhance PMT.\n\nEligibility:\n\nChildren aged 8 to 13 years with DBDs. A parent or guardian is also needed.\n\nDesign:\n\nParents will have 12 weekly sessions of PMT. PMT teaches them how to manage their child s mood and behaviors. Parents will learn to actively ignore, praise, set limits, and handle temper outbursts. PMT can be either in person or via video. Sessions last 30 to 60 minutes. They will be video and audio recorded.\n\nParents will be divided into 2 groups. Only 1 group will download a smartphone app. The app helps parents practice PMT skills. It offers videos, a resource library, and alerts when a child may be at risk for various behaviors.\n\nAll parents will be prompted every day to answer questions about their child s mood and their own behavior. These will continue until 12 weeks after their last PMT session.\n\nChildren will also answer questions on their phone daily for 1 week at a time. They will do this on 3 different weeks, each about 2 months apart. They will also have check-ins by phone every 2 weeks for up to 6 months.\n\nParents will have follow-up calls 3, 6, and 12 months after they finish PMT.","conditions":["Disruptive Behavior Disorders","Conduct Disorder","Oppositional Defiant Disorder","Attention-deficit/Hyperactivity Disorder"],"keywords":["Disruptive Behavior Disorders","Parent Management Training","Children","Parents","Digital tool","Irritability","Temper outbursts"],"interventions":[{"type":"BEHAVIORAL","name":"Psychotherapy"}],"enrollment":200,"startDate":"2026-11-15","completionDate":"2036-12-31","sex":"ALL","minAge":"8 Years","maxAge":"13 Years","healthyVolunteers":false,"eligibilityRaw":"* INCLUSION CRITERIA:\n\nInclusion Criteria for Youth:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into protocol 01-M-0254 for screening purposes\n* Age 8-13 years (8 years 0 months through 13 years 11 months)\n* Parent/guardian and/or child reports irritability as a primary clinical concern. Specifically, compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.\n* On the basis of record review and interviews with child and parent or guardian, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e., CGI-S of 3 or more). This criterion is assessed based on the clinical interview conducted with parent/guardian and child after consenting into protocol 01-M-0254 for screening.\n* Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement.\n\n  --This study uses English-language manualized PMT. The PMT intervention materials, digital tool, therapist and rater training and supervision procedures, fidelity ratings, and outcome measures are currently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Enrolling non-English speakers can introduce a confound to our research objectives around feasibility, symptom and behavior change, and acceptability and fidelity. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n* At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent.\n* The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document.\n\nInclusion Criteria for Parent or Guardian:\n\nTo be eligible to participate, an individual must be enrolled in the 01-M-0254 protocol. All screening will occur under 01-M-0254 and all inclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. To be eligible to participate, an individual must meet all the following criteria:\n\n* Enrollment into 01-M-0254 for screening purposes\n* Parent or guardian of a child eligible for this protocol that can attend 12 PMT sessions and is willing to use the digital tool\n* Fluent in English after consenting into protocol 01-M-0254 as determined through clinical judgement\n* Ability of parent or guardian to understand the consent form and the willingness to sign a written informed consent document\n\nEXCLUSION CRITERIA:\n\nExclusion Criteria for Youth:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), have active suicidal intent or plan as detected on screening instruments\n* IQ \\< 70\n* Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nExclusion Criteria for Parent or Guardian:\n\nAll screening will occur under 01-M-0254 and all exclusion criteria for youth and parent or guardian will be determined under the 01-M-0254 protocol. Participants will be screened to exclude participants who would not be able to engage in psychotherapy. All individuals meeting any of the exclusion criteria at baseline will be excluded from participation.\n\n* IQ \\< 70 as assessed via a neuropsychological assessment or via assessment by trained clinical staff\n* Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n* Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment but not including self-help groups).","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Melissa A Brotman, Ph.D.","phone":"(301) 435-6645","email":"irritablekids@mail.nih.gov"}],"primaryOutcomes":["Dropout in each arm of the trial"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Psychotherapy for Disruptive Behavior Disorders","inPlainEnglish":"Background: Pediatric disruptive behavior disorders (DBDs) are characterized by severe irritability, anger, and temper outbursts. The primary way to treat children with DBDs is parent management training (PMT).","whoItsFor":["Ages 8 Years to 13 Years","who can join for Youth:","Enrollment into protocol 01-M-0254 for screening purposes","Age 8-13 years (8 years 0 months through 13 years 11 months)","Patients must be fluent in (speaking, reading) English after consenting into protocol 01-M-0254 as determined through clinical judgement","At least one parent or guardian of the minor subject must be willing to enroll in the protocol and have the cognitive ability to consent","The minor subject must be able understand a written assent document as determined through clinical judgement, as well as be willing to sign a written assent document","who can join for Parent or Guardian:"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Bethesda. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.639Z"},{"nctId":"NCT07766213","title":"Pain Phenotypes in Individuals With Multiple Sclerosis","officialTitle":"Pain Phenotyping in Multiple Sclerosis Based on IASP Criteria","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Kutahya Health Sciences University","sponsorClass":"OTHER","summary":"This observational cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes. The assessment will include clinical history, pain characteristics and distribution, quantitative sensory testing, pain intensity, disease severity, fatigue, health-related quality of life, and pain catastrophizing. The clinical characteristics of participants with different pain phenotypes will subsequently be compared.","conditions":["Multiple Sclerosis","Chronic Pain"],"keywords":["CHRONIC PAIN","NEUROPATHIC PAIN","NOCIPLASTIC PAIN","MULTIPLE SCLEROSIS"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Pain classification method"}],"enrollment":60,"startDate":"2026-08-15","completionDate":"2027-06-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Definite diagnosis of multiple sclerosis according to the McDonald criteria\n* No MS relapse or high-dose steroid treatment within the previous 3 months\n* Pain intensity ≥2 on the Numeric Rating Scale in at least one body region for at least 3 months\n* Ability to read, understand, and communicate in Turkish\n\nExclusion Criteria:\n\n* Pregnancy\n* Severe psychiatric disorder and/or severe cognitive impairment confirmed by a neurologist or neuropsychiatrist\n* Presence of a serious pathology or disease that may compromise the assessment process or affect clinical decision-making, including metastasis, cancer, untreated or unhealed fractures, neurological disorders other than multiple sclerosis, or a history of diabetes","locations":[{"facility":"Kutahya Health Sciences University Physical Medicine and Rehabilitation Department","city":"Kütahya","state":"Turkiye","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nisa TURUTGEN, Msc.","phone":"00902742651300","email":"nisa.turutgen@ksbu.edu.tr"}],"primaryOutcomes":["Quantitative sensory test: static tactile mechanical threshold","Quantitative sensory test: hot-cold pain threshold","Quantitative sensory test: static mechanical allodynia","Quantitative sensory test: dynamic mechanical allodynia","Quantitative sensory test: vibration sense","Margolis Pain Diagram"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["k-tahya-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Pain classification method for Multiple Sclerosis","inPlainEnglish":"This watch-and-measure (no experimental treatment required) cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Definite diagnosis of multiple sclerosis according to the McDonald criteria","No MS relapse or high-dose steroid treatment within the previous 3 months","Pain intensity ≥2 on the Numeric Rating Scale in at least one body region for at least 3 months","Ability to read, understand, and communicate in Turkish"],"whoShouldSkip":["Severe psychiatric disorder and/or severe cognitive impairment confirmed by a neurologist or neuropsychiatrist","Presence of a serious pathology or disease that may compromise the assessment process or affect clinical decision-making, including metastasis, cancer, untreated or unhealed fractures, neurological disorders other than multiple sclerosis, or a history of diabetes"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at Kütahya. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.971Z"},{"nctId":"NCT07766265","title":"NEST: A Group Intervention for Parents With Complex PTSD","officialTitle":"NEST - Nurturing Emotional Safety in Trauma-Affected Parenting: A Pilot Feasibility and Acceptability Study of a Trauma-Informed Parenting Intervention for Parents With ICD-11 Complex Post-Traumatic Stress Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"St.Gallen University of Applied Sciences","sponsorClass":"OTHER","summary":"The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need. The main questions it aims to answer are:\n\n* Is the NEST group intervention feasible to deliver and acceptable to parents with Complex PTSD?\n* Do parents' trauma-related symptoms and their experience of the parenting role change from before to after the intervention?\n\nParticipants will:\n\n* Complete online questionnaires about trauma-related symptoms and parenting before the group therapy, after it ends, and again three months later\n* Take part in nine weekly 90-minute group therapy sessions, co-led by a member of the study team and a mental health professional from the treatment site\n* Some participants will additionally be invited to a short interview about their experience with the group therapy","conditions":["Complex Post-Traumatic Stress Disorder"],"keywords":["Complex Post-Traumatic Stress Disorder","CPTSD","ICD-11","Trauma-Informed Intervention","Parents","Parenting Intervention","Group Therapy"],"interventions":[{"type":"BEHAVIORAL","name":"Trauma-Informed Parenting Group Intervention"}],"enrollment":32,"startDate":"2026-08-01","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist\n* Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)\n* Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)\n* Age 18 years or older\n* Sufficient German language proficiency to participate in group sessions and complete study questionnaires\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment\n* Severe cognitive impairment or inability to participate adequately in group-based procedures\n* No current contact with the child\n* Insufficient German language proficiency","locations":[{"facility":"Psychiatrische Dienste Aargau (PDAG)","city":"Windisch","state":"Canton of Aargau","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Switzerland University of Applied Sciences (OST)","city":"Sankt Gallen","state":"Canton of St. Gallen","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Integrierte Psychiatrie Winterthur (ipw)","city":"Winterthur","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joelle Albrecht, MSc","phone":"+41 58 257 32 99","email":"joelle.albrecht@ost.ch"},{"name":"Rahel Bachem, PhD","phone":"+41 58 257 35 26","email":"rahel.bachem@ost.ch"}],"primaryOutcomes":["Feasibility - Enrollment/ Recruitment Rate","Feasibility - Retention Rate","Feasibility - Intervention Adherence (Session Attendance)","Feasibility - Protocol Deviations","Acceptability - TFA Questionnaire","Acceptability - Qualitative Interviews"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["windisch-switzerland","sankt-gallen-switzerland","winterthur-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: Trauma-Informed Parenting Group Intervention for Complex Post-Traumatic Stress Disorder","inPlainEnglish":"The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences. Parenting can be especially challenging for people with this condition, and few treatment programs currently address this specific need.","whoItsFor":["Ages 18 Years to any","Diagnosis of CPTSD according to ICD-11, confirmed by the treating psychotherapist or psychiatrist","Caregiver of at least one child aged 0-18 years (including biological, adoptive, step-, or foster parents and other primary caregivers)","Currently receiving individual psychotherapeutic treatment (outpatient or inpatient setting)","Age 18 years or older","Sufficient German language proficiency to participate in group sessions and complete study questionnaires"],"whoShouldSkip":["Current acute psychosis or severe psychiatric instability requiring immediate intensive treatment","Severe cognitive impairment or inability to participate adequately in group-based procedures","No current contact with the child","Insufficient German language proficiency"],"whatHappens":"If you join, the listed intervention(s) are Trauma-Informed Parenting Group Intervention. The registry lists allocation as na. The goal of this pilot clinical trial is to learn whether NEST, a new trauma-informed group therapy program, is feasible and acceptable for parents with Complex PTSD, a condition that can develop after prolonged or repeated traumatic experiences.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 32 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.405Z"},{"nctId":"NCT07767396","title":"Eye Movement Intervention With Different Memory Reactivation Procedures for Intrusive Traumatic Memories","officialTitle":"The Effects of Different Memory Reactivation Procedures Combined With Bilateral Eye Movements on Intrusive Memories and PTSD Symptoms: A Three-Arm Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Shaanxi Normal University","sponsorClass":"OTHER","summary":"Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) may be effective, they often involve engagement with trauma-related memories, which can be distressing for some individuals and may affect treatment acceptability. This randomized controlled trial will evaluate a standardized eye-movement-based procedure for trauma-exposed individuals experiencing recurrent intrusive memories. Participants will be randomly assigned to one of several memory-related task conditions involving eye movements. The study will assess the frequency and distress of trauma-related intrusive memories at prespecified assessment points, as well as PTSD symptoms, intervention-related distress, acceptability, and safety. Findings from this trial may help inform the development of tolerable approaches for targeting trauma-related intrusive memories.","conditions":["Post-traumatic Stress Disorder (PTSD)","Intrusive Memories of Traumatic Event(s)"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Unconscious Trauma Reactivation plus Eye Movements"},{"type":"BEHAVIORAL","name":"Active Trauma Memory Reactivation plus Eye Movements"},{"type":"BEHAVIORAL","name":"Neutral Memory Reactivation plus Eye Movements"}],"enrollment":117,"startDate":"2026-10-30","completionDate":"2028-09-15","sex":"ALL","minAge":"18 Years","maxAge":"50 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Meet DSM-5 PTSD Criterion A, such as exposure to actual or threatened death, serious injury, or sexual violence; have experienced one or more traumatic events.\n2. Experienced five or more trauma-related intrusive memories during the baseline week.\n3. Have internet access and access to a personal computer suitable for completing the online study tasks.\n4. Have normal or corrected-to-normal vision and be able to complete computerized visual and eye movement tasks.\n5. Be willing to provide informed consent, able to complete study procedures, and able to be contacted by the study team.\n\nExclusion Criteria:\n\n1. Have fewer than five trauma-related intrusive memories during the baseline week.\n2. Have a current or past psychotic disorder, current manic episode, severe obsessive-compulsive disorder, severe personality disorder, or another severe psychiatric condition judged to interfere with study participation, adherence, or safety.\n3. Have current acute suicidal ideation or behavior, significant risk of harm to self or others, or any condition requiring urgent clinical intervention.\n4. Have current severe substance use disorder or severe substance dependence judged to interfere with study participation or safety.\n5. Have a current organic disorder, neurological condition, history of epilepsy or seizures, significant brain injury, or other medical condition judged to interfere with safe participation or completion of the computerized visual or eye movement tasks.\n6. Have visual impairment or other condition that prevents completion of the computerized visual or eye movement tasks.\n7. Current participation in another intervention study or current treatment judged by the research team to interfere with study participation, safety, or outcome assessment.","locations":[{"facility":"School of Psychology, Shaanxi Normal University","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zhu Zijian","phone":"+86 13572494696","email":"zhuzijian0203@snnu.edu.cn"}],"primaryOutcomes":["Number of trauma-related intrusive memories"],"hasResults":false,"conditionSlugs":["als","ptsd"],"drugSlugs":[],"locationSlugs":["xian-china"],"enrichment":{"headline":"Not a traditional drug phase: Unconscious Trauma Reactivation plus Eye Movements for Post-traumatic Stress Disorder (PTSD)","inPlainEnglish":"Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) may be effective, they often involve engagement with trauma-related memories, which can be distressing for some individuals and may affect treatment acceptability.","whoItsFor":["Ages 18 Years to 50 Years","Meet DSM-5 PTSD Criterion A, such as exposure to actual or threatened death, serious injury, or sexual violence; have experienced one or more traumatic events","Experienced five or more trauma-related intrusive memories during the baseline week","Have internet access and access to a personal computer suitable for completing the online study tasks","Have normal or corrected-to-normal vision and be able to complete computerized visual and eye movement tasks"],"whoShouldSkip":["Have fewer than five trauma-related intrusive memories during the baseline week","Have a current or past psychotic disorder, current manic episode, severe obsessive-compulsive disorder, severe personality disorder, or another severe psychiatric condition judged to interfere with study participation, adherence, or safety","Have current acute suicidal ideation or behavior, significant risk of harm to self or others, or any condition requiring urgent clinical intervention","Have current severe substance use disorder or severe substance dependence judged to interfere with study participation or safety","Have a current organic disorder, neurological condition, history of epilepsy or seizures, significant brain injury, or other medical condition judged to interfere with safe participation or completion of the computerized visual or eye movement tasks","Have visual impairment or other condition that prevents completion of the computerized visual or eye movement tasks","Current participation in another intervention study or current treatment judged by the research team to interfere with study participation, safety, or outcome assessment"],"whatHappens":"If you join, the listed intervention(s) are Unconscious Trauma Reactivation plus Eye Movements, Active Trauma Memory Reactivation plus Eye Movements, or Neutral Memory Reactivation plus Eye Movements. The registry lists allocation as randomized. Post-Traumatic Stress Disorder (PTSD) and trauma-related symptoms are often characterized by recurrent intrusive memories that cause distress and interfere with daily functioning.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 117 people at Xi'an. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.417Z"},{"nctId":"NCT07767903","title":"A Trial of the Efficacy and Safety of a Fixed Dose of SEP-363856 in Adults With Generalized Anxiety Disorder","officialTitle":"A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Trial to Compare the Efficacy and Safety of a Fixed Dose of SEP-363856 to Placebo in the Treatment of Adults With Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsorClass":"INDUSTRY","summary":"This is a global, phase 3, randomized, double-blind, parallel-group, 2-arm, placebo controlled, multicenter trial designed to compare the efficacy, safety and tolerability of a fixed dose of SEP-363856 (75 millligrams per day \\[mg/day\\]) to placebo over an 8-week double-blind treatment period in adults with generalized anxiety disorder (GAD).","conditions":["Generalized Anxiety Disorder"],"keywords":["Generalized Anxiety Disorder","GAD","Anxiety"],"interventions":[{"type":"DRUG","name":"SEP-363856"},{"type":"DRUG","name":"Placebo"}],"enrollment":384,"startDate":"2026-08-06","completionDate":"2028-10-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n1. Male or female participants at least 18 years of age at the time of informed consent\n2. Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation\n3. Body Mass Index (BMI) 18-40 kilograms per square meter (kg/m\\^2)\n4. Participant is willing and able to comply with study procedures and visit schedule\n5. Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures\n6. Willing and able to discontinue prohibited medications/therapies per protocol\n7. (i ) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception (ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions\n8. Willing and able to discontinue prohibited medications/therapies per protocol\n\nKey Exclusion Criteria\n\n1. Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening\n2. Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening\n3. Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)\n4. Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \\[C-SSRS\\] or MADRS)\n5. Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)\n6. Prior exposure to restricted treatments\n7. Pregnant or breastfeeding females\n8. Participation in another investigational study within 180 days (or more than \\[\\>\\] 1 trial in last year)\n9. Known history of human immunodeficiency virus seropositivity, hepatitis B or C","locations":[{"facility":"Anderson Clinical Research","city":"Redlands","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions Inc. (CNS) - Orlando","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical - Watertown","city":"Watertown","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lumina Clinical Research Center","city":"Cherry Hill","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Basil Clinical","city":"Jamaica","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research NYC Uptown","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Summit Research Network","city":"Portland","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Adams Clinical Philadelphia","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare - Memphis","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research - Bellaire","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Core Clinical Research","city":"Everett","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Otsuka Call Center","phone":"844-687-8522","email":"ProfessionalServices@otsuka-us.com"}],"primaryOutcomes":["Change From Baseline at Week 8 in Hamilton Anxiety Rating Scale (HAM-A) Total Score"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["redlands-california","orlando-florida","watertown-massachusetts","cherry-hill-new-jersey","jamaica-new-york","new-york-new-york","portland-oregon","philadelphia-pennsylvania","memphis-tennessee","houston-texas","everett-washington"],"enrichment":{"headline":"Phase 3: testing SEP-363856 for Generalized Anxiety Disorder","inPlainEnglish":"This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 2-arm, dummy treatment (placebo) controlled, multicenter trial designed to compare the how well it works, whether it is safe and how hard side effects are to live with of a fixed dose of SEP-363856 (75 millligrams per day \\[mg/day\\]) to dummy treatment (placebo) over an 8-week neither you nor the study doctors know who gets the real treatment treatment period in adults with generalized anxiety disorder (GAD).","whoItsFor":["Ages 18 Years to any","Primary diagnosis of GAD per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by Mini-International Neuropsychiatric Interview (MINI) and clinical psychiatric evaluation","Body Mass Index (body-mass index (BMI)) 18-40 kilograms per square meter (kg/m\\^2)","Participant is willing and able to comply with study procedures and visit schedule","Medically stable as determined by medical history, physical exam, vital signs, and laboratory tests and able to comply with study procedures","Willing and able to discontinue prohibited medications/therapies per protocol","(i ) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception (ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions"],"whoShouldSkip":["Current DSM-5 diagnosis of major depressive episode, post traumatic stress disorder (PTSD), or any psychiatric disorder other than GAD that was the primary focus of treatment within 12 months prior to screening","Substance use disorder (excluding nicotine/caffeine) within 12 months prior to screening","Lifetime history of certain psychiatric disorders (e.g., schizophrenia spectrum disorders, bipolar disorder, obsessive-compulsive disorder, borderline or antisocial personality disorder)","Significant suicide risk e.g., recent suicidal behavior/ideation per Columbia-Suicide Severity Rating Scale \\[C-SSRS\\] or MADRS)","Use of prohibited medications/therapies within protocol-defined timeframes (e.g., certain antipsychotics, mood stabilizers, benzodiazepines, investigational treatments)","Prior exposure to restricted treatments","Pregnant or breastfeeding females"],"whatHappens":"If you join, the listed intervention(s) are SEP-363856, or Placebo. The registry lists allocation as randomized. This is a global, phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-group, 2-arm, dummy treatment (placebo) controlled, multicenter trial designed to compare the how well it works, whether it is safe and how hard side effects are to live with of a fixed dose of SEP-363856 (75 millligrams per day \\[mg/day\\]) to dummy treatment (placebo) over an 8-week neither you nor the study doctors know who gets the real treatment treatment period in adults with generalized anxiety disorder (GAD).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 384 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.351Z"},{"nctId":"NCT07770022","title":"Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER)","officialTitle":"Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor Cohort (VIPER)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"The purpose of this study is to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection.\n\nParticipants will provide health information and biological samples, such as blood, saliva, stool, and, for some participants, tissue biopsies. These samples will be used to study the biological processes involved in Long COVID and to support the development of new diagnostic tests that may improve future research, clinical trials, and patient care.","conditions":["Long Covid"],"keywords":["Long COVID"],"interventions":[],"enrollment":150,"startDate":"2026-05-18","completionDate":"2031-05-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to provide written informed consent, and\n* Age \\>/= 18 years, and\n* Either:\n\nHistory of a SARS-CoV-2 infection resulting in Long COVID symptoms, confirmed by the investigator, or\n\nExposure to SARS-CoV-2 without establishment of Long COVID.\n\n* Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC).\n* Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols.\n\nExclusion Criteria:\n\n* Self-reported or documented chronic anemia with hemoglobin \\< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary.\n* Serious medical or psychiatric illness that, in the opinion of the site investigator, would interfere with the ability to adhere to study requirements or to give informed consent.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.","locations":[{"facility":"Zuckerberg San Francisco General Hospital","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"VIPER Study UCSF","phone":"(415) 502-2449","email":"VIPERStudy@ucsf.edu"},{"name":"Lynn Ngo, MPH","phone":"(415) 322-8432","email":"Lynn.Ngo@ucsf.edu"}],"primaryOutcomes":["Participant age","Participant sex","Participant race/ethnicity","Proportion of participants previously hospitalized","Colonoscopy Completed"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Validation of Biomarkers for Long COVID in the LIINC Viral Immunopathogenesis and Persistence Repeat Donor …","inPlainEnglish":"This study wants to better understand the biological changes associated with Long COVID and to identify laboratory tests (biomarkers) that may help diagnose the condition and measure how it changes over time. Researchers will enroll people with Long COVID as well as people who have fully recovered after COVID-19 infection.","whoItsFor":["Ages 18 Years to any","Age \\>/= 18 years, and","History of a SARS-CoV-2 infection resulting in Long COVID symptoms, confirmed by the investigator, or","Exposure to SARS-CoV-2 without establishment of Long COVID","Enrolled or willing to enroll and complete at least 1 visit in the UCSF Long-term Impact of Infection with Novel Coronavirus (LIINC)","Enrolled or willing to be referred for a gut biopsy procedure under related IRB-approved protocols"],"whoShouldSkip":["Self-reported or documented chronic anemia with hemoglobin \\< 9 g/dL. Anemia during a preceding acute illness will not be exclusionary","Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at San Francisco. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.243Z"},{"nctId":"NCT07770152","title":"Semaglutide in Youth With Autism Spectrum Disorder","officialTitle":"Semaglutide for Metabolic and Adiposity-Related Targets in Youth With Autism Spectrum Disorder (SMART-ASD)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Children's Hospital Medical Center, Cincinnati","sponsorClass":"OTHER","summary":"This study is a 6-month, two-arm, RCT which will evaluate the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (BMI, kg/m²) from baseline to Month 6. Secondary, descriptive outcomes are changes in metabolic parameters (e.g., lipid levels), side effects, and compliance with semaglutide.","conditions":["Autism Spectrum Disorder","Obesity"],"keywords":["Autism Spectrum Disorder","Obesity","Semaglutide"],"interventions":[{"type":"DRUG","name":"Glucagon-like peptide-1 receptor agonist：Semaglutide"},{"type":"BEHAVIORAL","name":"Lifestyle Management (LSM) Counseling"}],"enrollment":42,"startDate":"2026-10-18","completionDate":"2028-09-01","sex":"ALL","minAge":"12 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria (Semaglutide Group):\n\n* 12-18 years of age\n* Epic-confirmed diagnosis of ASD\n* Obesity defined as BMI ≥95th percentile for age and sex\n* Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket\n* Have a parent who is willing to provide informed consent\n* Can attend in-person, e-visits, or telehealth visits for 12 months\n* English speaking\n\nExclusion Criteria (Semaglutide Group):\n\n* Healthworks patient who has lost \\>5% body weight over the past 3 months\n* Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months\n* Have Type 1 or Type 2 diabetes\n* Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2\n* Have been on GLP-1 RAs in the past 12 months\n* Have significant GI conditions (e.g., pancreatitis),\n* Are pregnant or breastfeeding\n* Have catatonia or a condition that may affect compliance and safety\n\nInclusion Criteria (Historical Control Group):\n\n* Healthworks patients treated between January 1, 2021-December 31, 2025\n* 12-18 years of age\n* Confirmed diagnosis of ASD\n* Have obesity defined as BMI ≥95th percentile for age and sex\n* Have BMI and SMM outcomes assessed at M0, M6, or M12\n* Age groups 12-14 years old and 15-18 years old and sex matched to youth in the semaglutide group","locations":[{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mary Banks","phone":"513-803-3123","email":"mary.banks@cchmc.org"}],"primaryOutcomes":["Number of Participants With Percent Change in BMI (kg/m2)","Number of Participants With Change in Skeletal Muscle Mass (SMM)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["cincinnati-ohio"],"enrichment":{"headline":"Phase 4: testing Glucagon-like peptide-1 receptor agonist：Semaglutide for Autism Spectrum Disorder","inPlainEnglish":"This study is a 6-month, two-arm, RCT which will measure the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity. The primary outcome is change in body mass index (body-mass index (BMI), kg/m²) from baseline to Month 6.","whoItsFor":["Ages 12 Years to 18 Years","(Semaglutide Group):","Epic-confirmed diagnosis of ASD","Obesity defined as body-mass index (BMI) ≥95th percentile for age and sex","Have Medicaid or other insurance that will cover semaglutide or the parent is willing to pay for semaglutide out of pocket","Can attend in-person, e-visits, or telehealth visits for 12 months"],"whoShouldSkip":["(Semaglutide Group):","Healthworks patient who has lost \\>5% body weight over the past 3 months","Are on a weight loss-promoting medication such as Metformin or Topamax with a dose change in the past 3 months","Have Type 1 or Type 2 diabetes","Have a personal or first-degree family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia 2","Have been on GLP-1 RAs in the past 12 months","Have significant GI conditions (e.g., pancreatitis),"],"whatHappens":"If you join, the listed intervention(s) are Glucagon-like peptide-1 receptor agonist：Semaglutide, or Lifestyle Management (LSM) Counseling. The registry lists allocation as randomized. This study is a 6-month, two-arm, RCT which will measure the effectiveness and safety of semaglutide in adolescents aged 12-18 years with autism spectrum disorder (ASD) and obesity.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 42 people at Cincinnati. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.835Z"},{"nctId":"NCT07770711","title":"Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With PCOS","officialTitle":"Comparison of Inositol and Metformin Administration in Mediterranean Diet and Low-Carbohydrate Diets in Women With Polycystic Ovary Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Dicle University","sponsorClass":"OTHER","summary":"Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain. This randomized, controlled, open-label, parallel-group trial aims to compare the effects of a Mediterranean diet (MD) and a low-carbohydrate diet (LCD), each combined with metformin, inositol, or folic acid (active control), in obese women with PCOS and IR. A total of 102 participants will be randomly assigned to one of six intervention groups and followed for two months. Anthropometric measurements, body composition, biochemical parameters, and hedonic hunger will be assessed at baseline and after the intervention. The primary outcome is the change in insulin resistance, assessed by the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), from baseline to 2 months. Secondary outcomes include changes in body composition, metabolic and biochemical parameters, and hedonic hunger.","conditions":["PCOS (Polycystic Ovary Syndrome)","Insulin Resistance","Obesity (BMI>30)"],"keywords":["Mediterranean diet","low-carbohydrate diet","insulin resistance","inositol","pcos"],"interventions":[{"type":"DRUG","name":"Metformin"},{"type":"DIETARY_SUPPLEMENT","name":"İnositol"},{"type":"DIETARY_SUPPLEMENT","name":"Folic Acid"},{"type":"OTHER","name":"Mediterranean diet"},{"type":"OTHER","name":"Low-Carbohydrate Diet"}],"enrollment":90,"startDate":"2026-08-13","completionDate":"2027-09","sex":"FEMALE","minAge":"20 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged 20-40\n* Diagnosed with PCOS (Rotterdam, 2004)\n* Insulin resistant (newly diagnosed or diagnosed within the last 3 months)\n* Obese according to the World Health Organization (2006) in grades 1 and 2 (BMI: 30-40 kg/m²)\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Those undergoing/contemplating IVF treatment\n* Early menopause diagnosis\n* Diabetes diagnosis, use of oral antidiabetic agents\n* Chronic diseases (liver, kidney diseases, cancer)\n* Psychiatric illnesses\n* Those taking routine medication for any reason\n* Use of hormonal contraceptive methods within the last 3 months\n* Active smokers and alcohol users or social drinkers\n* Change in body weight of more than 10% in the last 6 months for any reason","locations":[{"facility":"Dicle University Hospital","city":"Diyarbakır","state":"Diyarbakır","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Esra Ucar, MSc","phone":"+90 555 993 1894","email":"esra.ucar@dicle.edu.tr"}],"primaryOutcomes":["Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) from Baseline to 2 Months"],"hasResults":false,"conditionSlugs":["obesity","pcos"],"drugSlugs":[],"locationSlugs":["diyarbak-r-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: testing Metformin for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction. Although lifestyle modification is recommended as first-line therapy, the optimal dietary approach for women with PCOS remains uncertain.","whoItsFor":["Ages 20 Years to 40 Years","Women only","Diagnosed with PCOS (Rotterdam, 2004)","Insulin resistant (newly diagnosed or diagnosed within the last 3 months)","Obese according to the World Health Organization (2006) in grades 1 and 2 (body-mass index (BMI): 30-40 kg/m²)"],"whoShouldSkip":["Pregnant or breastfeeding women","Those undergoing/contemplating IVF treatment","Early menopause diagnosis","Diabetes diagnosis, use of oral antidiabetic agents","Chronic diseases (liver, kidney diseases, cancer)","Psychiatric illnesses","Those taking routine medication for any reason"],"whatHappens":"If you join, the listed intervention(s) are Metformin, İnositol, or Folic Acid. The registry lists allocation as randomized. Polycystic ovary syndrome (PCOS) is a common endocrine disorder frequently associated with obesity, insulin resistance (IR), and metabolic dysfunction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Diyarbakır. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.788Z"},{"nctId":"NCT07770919","title":"Continuous Theta Burst Stimulation for Generalized Anxiety Disorder","officialTitle":"A Randomized Rater-Blinded Trial Comparing Continuous Theta Burst Stimulation Targeting the Right Posterior Parietal Cortex and Right Dorsolateral Prefrontal Cortex for Generalized Anxiety Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Military Hospital 175","sponsorClass":"OTHER","summary":"This randomized, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). Participants will be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC). Participants may be psychotropic-medication naïve or may continue stable psychotropic medication according to the protocol-defined medication stability criteria.\n\nThe primary objective is to compare changes in anxiety symptom severity, measured using the Hamilton Anxiety Rating Scale (HAM-A), from baseline to the end-of-treatment assessment. Secondary and exploratory assessments include treatment response and remission, quality of life, sleep quality, cognitive function, safety and tolerability, resting electroencephalography (EEG), and transcranial magnetic stimulation combined with EEG (TMS-EEG).","conditions":["Generalized Anxiety Disorder"],"keywords":["Generalized Anxiety Disorder","Continuous Theta Burst Stimulation","cTBS","Transcranial Magnetic Stimulation","Posterior Parietal Cortex","Dorsolateral Prefrontal Cortex"],"interventions":[{"type":"DEVICE","name":"Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex"},{"type":"DEVICE","name":"Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex"}],"enrollment":40,"startDate":"2026-09-09","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Right-handed.\n* Diagnosis of generalized anxiety disorder (GAD) according to ICD-10 criteria (F41.1), confirmed by a psychiatrist.\n* GAD must be the primary diagnosis and the main reason for treatment at the time of enrollment. Current or past comorbid major depressive disorder will be identified and recorded.\n* Hamilton Anxiety Rating Scale (HAM-A) total score \\>18 at screening/baseline.\n* Able and willing to provide written informed consent and comply with essential study procedures.\n* Participants may be psychotropic-medication naïve or may be receiving psychotropic medication. Participants currently receiving psychotropic medication must have maintained the same medication(s) and dose(s) for at least 2 weeks before randomization; for fluoxetine, the required stable period is at least 4 weeks.\n\nExclusion Criteria:\n\n* Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI.\n* Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator.\n* Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels.\n* Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures.\n* History of epilepsy or seizures, except febrile seizures in childhood.\n* Bipolar disorder.\n* Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders.\n* Acute suicide risk, including clear suicidal ideation or behavior.\n* Alcohol or substance abuse or dependence within the previous 6 months.\n* A medical condition associated with a high seizure risk or a history of cranial surgery.\n* Current use of medication judged by the screening physician to substantially increase seizure risk, or rapid reduction/discontinuation of benzodiazepines, antiseizure medications, or other centrally acting medications associated with withdrawal or increased seizure risk.\n* Serum vitamin D level \\<20 ng/mL that has not been adequately corrected.\n* Elevated C-reactive protein associated with clinically significant acute infection or acute inflammatory illness that, in the investigator's judgment, may affect participant safety or study outcome assessment.\n* Pregnant or breastfeeding.\n* Unable to understand or complete essential study procedures. Participants with potentially reversible temporary exclusion conditions may be rescreened once the condition has been adequately corrected or clinically stabilized.","locations":[{"facility":"Military Hospital 175","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dang Minh Ly, MD","phone":"+84359999741","email":"drminhdang@outlook.com"}],"primaryOutcomes":["Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex for Generalized Anxiety Disorder","inPlainEnglish":"This randomly assigned, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD). you would be randomly assigned in a 1:1 ratio to receive cTBS targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC).","whoItsFor":["Ages 18 Years to 65 Years","Age 18 to 65 years","Diagnosis of generalized anxiety disorder (GAD) according to ICD-10 criteria (F41.1), confirmed by a psychiatrist","GAD must be the primary diagnosis and the main reason for treatment at the time of enrollment. Current or past comorbid major depressive disorder will be identified and recorded","Hamilton Anxiety Rating Scale (HAM-A) total score \\>18 at screening/baseline"],"whoShouldSkip":["Intracranial or head/neck metallic foreign bodies or implants that constitute a contraindication to TMS or MRI","Implanted electronic devices such as a cardiac pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator","Untreated or clinically unstable thyroid dysfunction based on abnormal TSH and/or free T4 levels","Clinically significant intracranial structural abnormalities that may affect TMS safety, neuropsychiatric presentation, or study neurophysiological measures","History of epilepsy or seizures, except febrile seizures in childhood","Other major psychiatric disorders, including schizophrenia, delusional disorder, or eating disorders","Acute suicide risk, including clear suicidal ideation or behavior"],"whatHappens":"If you join, the listed intervention(s) are Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex, or Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex. The registry lists allocation as randomized. This randomly assigned, rater-blinded clinical trial evaluates the effectiveness, safety, and tolerability of continuous theta burst stimulation (cTBS) in adults with generalized anxiety disorder (GAD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Ho Chi Minh City. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.355Z"},{"nctId":"NCT07771010","title":"The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus","officialTitle":"The Effect of Empagliflozin and Metformin on Oxidative Capacity and Microvascular Reactivity of Skeletal Muscle in Patients With Type 2 Diabetes Mellitus","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University Medical Centre Ljubljana","sponsorClass":"OTHER","summary":"The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle? The study will enroll 54 individuals with type 2 diabetes in a prospective, randomized, interventional, open-label study. Participants will be randomized into 3 equally sized groups: 1) a group receiving empagliflozin; 2) a group receiving metformin; and 3) a group receiving a combination of both drugs (empagliflozin and metformin). The investigators will analyze the clinical variables of the subjects, near-infrared spectroscopy (NIRS) measurements over the flexor digitorum superficialis muscle of the non-dominant arm at rest, after submaximal muscular work, and during transient brachial artery occlusion at specified time intervals (14 days, 1 month, 3 months, 6 months), as well as body composition, physical performance, and glycemic control following the pharmacological intervention.","conditions":["Diabetes Type 2"],"keywords":["type 2 diabetes mellitus","Empagliflozin","Metformin","Skeletal muscle oxidative capacity","Near-infrared spectroscopy","Microvascular reactivity"],"interventions":[{"type":"DRUG","name":"Empagliflozin (Jardiance®)"},{"type":"DRUG","name":"Metformin"},{"type":"COMBINATION_PRODUCT","name":"Synjardy® 12.5mg/1000mg film-coated tablets"}],"enrollment":54,"startDate":"2026-04-16","completionDate":"2027-12-31","sex":"MALE","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male sex\n* Age 18-75 years\n* Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment\n* Body mass index (BMI) 25-35 kg/m²\n* Currently managed at a diabetes outpatient clinic\n* No known chronic diabetes-related complications\n* No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas\n\nExclusion Criteria:\n\n* Other forms of diabetes mellitus (i.e., not type 2)\n* Type 2 diabetes mellitus known for more than 2 years\n* Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia\n* Known mitochondrial disease\n* Heart failure, NYHA class II or higher\n* Chronic kidney disease, stage 3 or higher\n* Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism)\n* Recurrent urinary tract infections\n* Active malignancy currently undergoing oncologic treatment\n* Life expectancy less than 3 months\n* Symptomatic hyperglycemia with fasting plasma glucose above 18 mmol/L, HbA1c ≥ 10%\n* Unwillingness to provide informed consent","locations":[{"facility":"UMC Ljubljana","city":"Ljubljana","state":"","country":"Slovenia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eva Podbregar Kolar, MD","phone":"+38640762768","email":"evapodbregar@gmail.com"}],"primaryOutcomes":["Change in skeletal muscle mitochondrial oxidative capacity"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":["empagliflozin"],"locationSlugs":["ljubljana-slovenia"],"enrichment":{"headline":"Phase 4: testing Empagliflozin (Jardiance®) for Diabetes Type 2","inPlainEnglish":"The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes. As the primary outcome, the investigators selected the change in skeletal muscle oxidative capacity and posed the following scientific question: Does empagliflozin significantly improve the oxidative capacity of skeletal muscle?","whoItsFor":["Ages 18 Years to 75 Years","Men only","Newly diagnosed type 2 diabetes mellitus, confirmed no more than 2 years prior to enrollment","Body mass index (body-mass index (BMI)) 25-35 kg/m²","Currently managed at a diabetes outpatient clinic","No known chronic diabetes-related complications","No prior antidiabetic pharmacological treatment, with the exception of sulfonylureas"],"whoShouldSkip":["Other forms of diabetes mellitus (i.e., not type 2)","Type 2 diabetes mellitus known for more than 2 years","Comorbidities known to independently affect skeletal muscle oxidative capacity, including: spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, cystic fibrosis, local joint immobility, or hemiplegia","Known mitochondrial disease","Heart failure, NYHA class II or higher","Chronic kidney disease, stage 3 or higher","Poorly controlled chronic medical conditions (e.g., arterial hypertension, hypothyroidism)"],"whatHappens":"If you join, the listed intervention(s) are Empagliflozin (Jardiance®), Metformin, or Synjardy® 12.5mg/1000mg film-coated tablets. The registry lists allocation as randomized. The purpose of the study is to compare the effect of empagliflozin, metformin, and the combination of both on the oxidative capacity of skeletal muscle and its microvascular reactivity in individuals with newly diagnosed type 2 diabetes.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 54 people at Ljubljana. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.622Z"},{"nctId":"NCT07771439","title":"A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease","officialTitle":"A Parallel Group, Phase 3, Randomized, Open-label, 2-arm Study to Demonstrate the Superiority of Belumosudil Versus Best Available Therapy (BAT) in Participants at Least 12 Years of Age With Chronic Graft Versus Host Disease (cGVHD) Refractory to or Recurrent After 2 to 5 Prior Lines of Systemic Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sanofi","sponsorClass":"INDUSTRY","summary":"Participants will be randomized 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation. The study will target patients post-ruxolitinib treatment, except where Investigators deemed ruxolitinib treatment for cGVHD not suitable. In the BAT arm, the study doctor will select one BAT based on clinical judgement, local availability etc. prior to randomization.\n\nParticipants randomized to the BAT arm will have the option to cross-over to open-label belumosudil treatment upon meeting predefined criteria.\n\nStudy details include:\n\n* The study duration will be defined as 3 years from LPI.\n* Individual participant duration on study will consist of:\n\n  * Up to 28 days for screening.\n  * Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD (except change from BAT to belumosudil during the cross-over), experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first.\n  * Thirty days of post treatment safety follow-up.\n  * Follow-up for cGVHD status as applicable.\n  * Long-term follow-up until death or end of study, whichever occurs first.","conditions":["Chronic Graft Versus Host Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Belumosudil"},{"type":"OTHER","name":"Best available therapy (BAT)"}],"enrollment":356,"startDate":"2026-10-12","completionDate":"2029-09-14","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participant must be at least 12 years of age at the time of signing the informed consent.\n* Participants who have undergone allo-HCT.\n* Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required.\n* Participant receiving systemic CNI and/or CS must be on a stable dose/regimen (prednisone equivalent \\<1 mg/kg/day for CS) for at least 2 weeks prior to randomization.\n* cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD.\n* Participant must have received ruxolitinib for the treatment of cGVHD unless the Investigator believes treatment with ruxolitinib for cGVHD was not suitable for the participant.\n* Participants and/or their LAR must accept to be treated with 1 of the following BAT options as recommended to them by the Investigator on Cycle 1 Day 1:\n\n  * ECP,\n  * Low-dose MTX,\n  * MMF,\n  * Rituximab,\n  * mTOR inhibitors (sirolimus, everolimus)\n  * Imatinib,\n  * Ibrutinib,\n  * Proteasome inhibitors,\n  * Pentostatin.\n* Body weight ≥ 30 kg I 09. Life expectancy of \\> 6 months.\n* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT.\n* Participants who meet any of the following criteria regarding systemic cGVHD treatments:\n\n  * Participants who newly initiated any systemic cGVHD treatment within 14 days prior to the date of randomization.\n  * Participants receiving systemic ruxolitinib treatment who are unable to meet the following requirements:\n* Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment).\n* No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period).\n\n  * Participants receiving other systemic cGVHD treatment (apart from CS and CNI) including investigational treatments who have not completed a washout period of at least 14 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil or BAT treatment.\n\nNote: Topical and organ-specific treatment for cGVHD and other supportive agents are allowed.\n\n* Participant has had previous exposure to belumosudil.\n* Participants with a Karnofsky Performance Scale (KPS) score \\<60 (if aged ≥16 years) or Lansky Performance Score of \\<60 (if aged \\<16 years).\n* Clinically uncontrolled chronic or ongoing infectious disease requiring antibiotic, antiviral, or antifungal treatment within 14 days prior to the date of randomization.\n* Impairment of GI function (unrelated to cGVHD) or GI disease (unrelated to cGVHD) that may significantly alter the absorption of belumosudil (such as ulcerative disease, malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or small bowel resection).\n* Administration of live or live-attenuated vaccines is prohibited within 28 days or 5 elimination half-lives of the respective vaccine, whichever is longer, prior to study treatment administration and until study intervention discontinuation.\n* Has a forced expiratory volume in the first second (FEV1) ≤39% or has lung score of 3 according to 2014 NIH consensus diagnostic and staging criteria.\n* Has any of the following lab results:\n\n  * Absolute neutrophil count \\<1.5 × 10⁹/L (for participants aged \\<18 years) or \\<1.0 × 109/L (for participants aged ≥18 years). The use of G-CSF is not allowed within 7 days before the screening hematological test.\n  * Platelet count \\<50 × 10⁹/L (for participants aged \\<18 years) or \\<25 × 109/L (for participants aged ≥18 years). Platelet transfusions are not allowed within 72 hours before the screening hematological test.\n  * ALT and/or AST \\>3 × ULN (\\>5 × ULN if abnormalities are due to cGVHD).\n  * Total bilirubin \\>1.5 × ULN (\\>3 × ULN if Gilbert's syndrome or due to cGVHD).\n  * eGFR \\<30 mL/min/1.73 m2 using the MDRD-4 variable formula (if aged ≥18 years) or using the Bedside Schwartz formula (if aged \\<18 years).\n* Participants with active viral diseases\n* Diagnosed or treated for another malignancy other than the underlying disease allo-HCT was indicated for, within 3 years prior to randomization with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in-situ malignancy, or low risk prostate cancer after curative therapy.\n* Hepatic impairment classified as Child-Pugh C or worse, with the exception of transient liver impairment attributable to GVHD.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","locations":[{"facility":"Investigational Site Number : 5280001","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240008","city":"Madrid","state":"Madrid, Comunidad de","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"Investigational Site Number : 7240009","city":"Madrid","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial Transparency email recommended (Toll free for US & Canada)","phone":"800-633-1610","email":"Contact-US@sanofi.com"}],"primaryOutcomes":["Overall response rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["amsterdam-netherlands","madrid-spain"],"enrichment":{"headline":"Phase 3: testing Belumosudil for Chronic Graft Versus Host Disease","inPlainEnglish":"You would be randomly assigned 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2). While treatment practices for cGVHD differ across regions, ruxolitinib has been approved by the European Commission since May 2022 and is expected to be broadly accessible throughout most EU member states by study initiation.","whoItsFor":["Ages 12 Years to any","Participants who have undergone allo-HCT","Participants with active moderate to severe cGVHD at the time of enrollment, defined using the NIH Consensus diagnosis and staging criteria for which the physician believes a new line of systemic therapy is required","Participant receiving systemic CNI and/or CS must be on a stable dose/regimen (prednisone equivalent \\<1 mg/kg/day for CS) for at least 2 weeks prior to randomization","cGVHD is refractory to, or has recurred following, at least 2 prior lines of systemic treatment. Participants must have received a minimum of 2 and a maximum of 5 prior systemic therapies for cGVHD","Participant must have received ruxolitinib for the treatment of cGVHD unless the Investigator believes treatment with ruxolitinib for cGVHD was not suitable for the participant","Participants and/or their LAR must accept to be treated with 1 of the following BAT options as recommended to them by the Investigator on Cycle 1 Day 1:","mTOR inhibitors (sirolimus, everolimus)"],"whoShouldSkip":["Any evidence (histologic, cytogenetic, molecular, hematologic, or mixed) of progressive or relapsed underlying disease or post-transplant lymphoproliferative disease after most recent allo-HCT","Participants who meet any of the following criteria regarding systemic cGVHD treatments:","Participants who newly initiated any systemic cGVHD treatment within 14 days prior to the date of randomization","Participants receiving systemic ruxolitinib treatment who are unable to meet the following requirements:","Ruxolitinib must be tapered and discontinued within 14 days following the first dose of belumosudil or BAT (allowing for a maximum overlap period of up to 14 days with belumosudil or BAT treatment)","No dose increases of ruxolitinib are permitted from 14 days prior to the date of randomization until permanent discontinuation of ruxolitinib (dose reductions and discontinuations are permitted during this period)","Participants receiving other systemic cGVHD treatment (apart from CS and CNI) including investigational treatments who have not completed a washout period of at least 14 days or 5 half-lives (whichever is shorter) prior to the first dose of belumosudil or BAT treatment"],"whatHappens":"If you join, the listed intervention(s) are Belumosudil, or Best available therapy (BAT). The registry lists allocation as randomized. You would be randomly assigned 1:1 to receive either belumosudil or Best Available Therapy (BAT), with stratification based on baseline cGVHD severity as defined by the 2014◦NIH consensus criteria (moderate versus severe), use of concomitant CS and/or CNI (ie, tacrolimus or cyclosporine) at baseline (Yes versus No), and the number of prior lines of therapies (2 versus more than 2).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 356 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.653Z"},{"nctId":"NCT07771855","title":"Efficacy of an Anti-TSLP Monoclonal Antibody in the Management of Chronic Bronchial Disease Induced by Bronchiolitis Obliterans Syndrome in Allogeneic Hematopoietic Stem Cells Transplantation Recipients","officialTitle":"Efficacy of an Anti-TSLP Monoclonal Antibody in the Management of Chronic Bronchial Disease Induced by Bronchiolitis Obliterans Syndrome in Allogeneic Hematopoietic Stem Cells Transplantation Recipients","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hopital Foch","sponsorClass":"OTHER","summary":"Allogeneic hematopoietic stem cell transplantation (HSCT) is burdened with a high morbidity and mortality rates. Graft versus host disease (GVHD) is the clinical manifestation of an immune conflict. The expression of GVHD in the bronchioles is responsible for bronchiolitis obliterans syndrome (BOS), defined by the appearance of an obstructive ventilatory disorder. BOS may affect up to 10% of allogeneic transplant recipients. Repeated aggression-repair phenomena of the bronchial epithelium lead to an irreversible fibrous remodeling. The management of BOS remains a therapeutic challenge. A number of patients worsen their ventilatory disorder despite the available treatments and progress to obstructive respiratory failure complicated by repeated bronchial exacerbations. When the patient is far from the allograft and in the absence of any sign of active extrathoracic GVHD, the mechanisms of aggravation of the ventilatory disorder are equivocal. It seems more likely that the bronchial disease evolves on its own due to a persistent local inflammation without any immunological conflict. In this case, it would be reasonable to model the management on that of severe bronchial diseases for which the logic of cortisone sparing is now permitted by the arrival of targeted biotherapies.\n\nSince 2006, the therapeutic arsenal of bronchial inflammatory pathologies, mainly asthma, has been enriched with the class of targeted biotherapies. These therapies, targeting IgE (omalizumab), Th2 cytokines IL-5, IL-4, IL-13 (mepolizumab, benralizumab, dupilumab) and more recently the cytokine derived from the bronchial epithelium TSLP (tezepelumab), have shown effectiveness in reducing bronchial exacerbations, improving quality of life and reducing dependence on corticosteroids. TSLP is an alarmin that reflects bronchial epithelial involvement.\n\nThe objective of this study is to test the performance of an anti-TSLP biotherapy (tezepelumab) in the reduction of bronchial exacerbations in alloHSCT recipients suffering from obstructive bronchial disorders not supposed to be still related to an active GVHD.","conditions":["Bronchiolitis Obliterans Syndrome (BOS)","HSCT","Bronchial Disease"],"keywords":["Efficacy anti-TSLP monoclonal antibody (tezepelumab) in chronic bronchial disease induced Bronchiolitis obliterans syndrome (BOS) in HSCT recipient.","BOS","HSCT","tezepzlumab"],"interventions":[{"type":"DRUG","name":"Tezepelumab"}],"enrollment":36,"startDate":"2026-06-24","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult recipients, minimum age 18\n2. Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant\n3. At more than 3 years after the date of the transplantation\n4. BOS defined by the occurrence of a new fixed obstructive ventilatory disorder after the allograft (accepted criteria: FEV1/FVC ≤70% and FEV1 \\< 75% pred value and decline of more than 10% over less than 2 years OR FEV1/FVC \\> 70% and FEV1 \\< 75% pred value and decline of FEV1 more than 10% over less than 2 years and Normal TLC \\> 80% OR decline of FEV1 more than 10% over less than 2 years and TLC \\> 120% and/or RV/TLC \\> 40%)\n5. Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months\n6. On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months.\n7. Stable dose of systemic immunosuppressive regimen for the last 4 weeks\n8. Being covered by a national health insurance\n9. Signed consent form\n\nExclusion Criteria:\n\n1. Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH\n2. FEV1\\< 20% theorical value\n3. Being deprived of liberty or under guardianship\n4. Absence of signed consent\n5. Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE\n6. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy\n7. Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria)\n8. History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy\n9. Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult\n10. Pregnant, breastfeeding or lactating women","locations":[{"facility":"CHU de Besançon","city":"Besançon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Haut-Lévêque - CHU Bordeaux","city":"Bordeaux","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU Caen Normandie","city":"Caen","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHRU de Lille","city":"Lille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hôpital Saint-Louis APHP","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Foch Hospital","city":"Suresnes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yahya DEBZA","phone":"+33 1 46 25 36 42","email":"y.debza@hopital-foch.com"},{"name":"DRCI Promotion","phone":"","email":"drci-promotion@hopital-fcoh.com"}],"primaryOutcomes":["Change in the annualized number of bronchial exacerbations"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":["dupilumab","tezepelumab"],"locationSlugs":["besan-on-france","bordeaux-france","caen-france","lille-france","paris-france","suresnes-france"],"enrichment":{"headline":"Phase 2: testing Tezepelumab for Bronchiolitis Obliterans Syndrome (BOS)","inPlainEnglish":"Allogeneic hematopoietic stem cell transplantation (HSCT) is burdened with a high morbidity and mortality rates. Graft versus host disease (GVHD) is the clinical manifestation of an immune conflict.","whoItsFor":["Ages 18 Years to any","Adult recipients, minimum age 18","Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant","At more than 3 years after the date of the transplantation","Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months","On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months","Stable dose of systemic immunosuppressive regimen for the last 4 weeks","Being covered by a national health insurance"],"whoShouldSkip":["Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH","FEV1\\< 20% theorical value","Being deprived of liberty or under guardianship","Absence of signed consent","Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE","A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy","Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria)"],"whatHappens":"If you join, the listed intervention(s) are Tezepelumab. The registry lists allocation as na. Allogeneic hematopoietic stem cell transplantation (HSCT) is burdened with a high morbidity and mortality rates.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 36 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.865Z"},{"nctId":"NCT07772921","title":"A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.\n\nThe study is seeking participants who:\n\n* Have a history of severe asthma for at least 12 months\n* Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic.\n\nThe study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.","conditions":["Asthma"],"keywords":[],"interventions":[{"type":"DRUG","name":"tilrekimig"},{"type":"OTHER","name":"Placebo"}],"enrollment":1100,"startDate":"2026-08-20","completionDate":"2029-06-01","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nMust meet the following asthma criteria:\n\n1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines.\n2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\\<24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma with within 12 months of the screening visit.\n3. Positive bronchodilator responsiveness of FEV1 or FVC \\>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol/albuterol (or equivalent SABA) at least once for spirometry conducted during screening period.\n\n   Other Inclusion Criteria:\n4. Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to, chronic obstructive pulmonary disease, other emphysematous lung disease such as alpha-1 antitrypsin disease, cystic fibrosis, emphysema, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.\n2. Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\n   Prior/Concomitant Therapy:\n3. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.\n4. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40/OX40L, IL-13, IL-33 / ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.\n5. Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).\n6. Bronchial thermoplasty within the previous 24 months.\n\n   Prior/Concurrent Clinical Study Experience:\n7. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.","locations":[{"facility":"Kern Research, Inc.","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovations Biotech","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chesapeake Clinical Research, Inc.","city":"White Marsh","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aa Mrc Llc","city":"Flint","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Revive Research Institute, Inc.","city":"Southfield","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hudson County Clinical Trials Research Center, LLC","city":"Union City","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vital Prospects Clinical Research Institute., PC","city":"Tulsa","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Smyrna Advanced Research, LLC","city":"Smyrna","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inquest Clinical Research","city":"Baytown","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"SMS Clinical Research LLC","city":"Garland","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SMS Clinical Research, LLC","city":"Mesquite","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Victoria Clinical Research Group","city":"Victoria","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kyushu Central Hospital","city":"Minamiku","state":"Fukuoka","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Showa Medical University Hospital","city":"Shinagawa","state":"Tokyo","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hiroshima Allergy & Respiratory Clinic Hacchobori","city":"Hiroshima","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Annualized asthma exacerbation rate over 52 weeks"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["bakersfield-california","miami-florida","white-marsh-maryland","flint-michigan","southfield-michigan","union-city-new-jersey","monroe-north-carolina","tulsa-oklahoma","smyrna-tennessee","baytown-texas","garland-texas","mesquite-texas","victoria-texas","minamiku-japan","shinagawa-japan","hiroshima-japan"],"enrichment":{"headline":"Phase 3: testing tilrekimig for Asthma","inPlainEnglish":"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.","whoItsFor":["Ages 12 Years to 80 Years","Must meet the following asthma criteria:","History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines","Other who can join:","Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening)"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Medical Conditions:","Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study","Prior/Concomitant Therapy:","Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit","Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig)","Bronchial thermoplasty within the previous 24 months"],"whatHappens":"If you join, the listed intervention(s) are tilrekimig, or Placebo. The registry lists allocation as randomized. The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,100 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.351Z"},{"nctId":"NCT07772960","title":"Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes","officialTitle":"Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Yale University","sponsorClass":"OTHER","summary":"This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus placebo in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.","conditions":["Alcohol Use Disorder (AUD)","Obesity (BMI Equal to or >30)"],"keywords":["Alcohol Use Disorder","alcohol craving","Semaglutide","food craving","alcohol intake"],"interventions":[{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"Semaglutide 1.0 mg"},{"type":"DRUG","name":"Semaglutide 2.0 mg"}],"enrollment":90,"startDate":"2026-10-01","completionDate":"2031-10-31","sex":"ALL","minAge":"18 Years","maxAge":"68 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male and females ages 18-60 and BMI in 30-49.9 kg/m2;\n* regular weekly alcohol use (at least 3X/week) prior to admission;\n* must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;\n* Good health as verified by screening and physical examination;\n* Able to read English and complete study evaluation;\n* Able to provide informed written and verbal consent.\n\nExclusion Criteria:\n\n* Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;\n* Current use of opiates;\n* Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;\n* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);\n* Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \\>6.5% and on current medications for T2D treatment;\n* Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;\n* Current use of any anti-obesity medications;\n* Prior history of bariatric surgery or current intragastric balloon;\n* Current participation in structured meal replacement or weight loss program;\n* Weight loss of \\>=10% over the preceding 6 months;\n* Women who are pregnant, nursing or refuse use of reliable form of birth control.","locations":[{"facility":"Yale Stress Center","city":"New Haven","state":"Connecticut","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"RAJITA SINHA, PHD","phone":"2037375805","email":"rajita.sinha@yale.edu"}],"primaryOutcomes":["Alcohol use days"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["new-haven-connecticut"],"enrichment":{"headline":"Phase 1: testing Semaglutide 1.0 mg for Alcohol Use Disorder (AUD)","inPlainEnglish":"This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus dummy treatment (placebo) in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.","whoItsFor":["Ages 18 Years to 68 Years","Male and females ages 18-60 and body-mass index (BMI) in 30-49.9 kg/m2;","regular weekly alcohol use (at least 3X/week) prior to admission;","must meet current DSM-V criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-V;","Good health as verified by screening and physical examination;","Able to read English and complete study evaluation;"],"whoShouldSkip":["Meet current criteria for moderate to severe substance use disorders from abuse of any another psychoactive substance, excluding nicotine;","Current use of opiates;","Current use of psychiatric medications, including benzodiazepine-based sedatives/anxiolytics and anticonvulsants, non SSRI antidepressants, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), acamprosate, naltrexone, antabuse, baclofen, varenicline;","Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);","Endocrine or immune disorders, including diagnosis of diabetes (T2D or T1D) by American Diabetes Association (ADA) criteria or a history of HgbA1c \\>6.5% and on current medications for T2D treatment;","Significant underlying medical conditions, including history of pancreatitis, acute kidney injury, medullary thyroid cancer, or MEN syndrome, as well as other cerebral, renal, thyroid or cardiac pathology that would preclude study participation;","Current use of any anti-obesity medications;"],"whatHappens":"If you join, the listed intervention(s) are Placebo, Semaglutide 1.0 mg, or Semaglutide 2.0 mg. The registry lists allocation as randomized. This study will examine two doses of 1.0 mg and 2.0 mg of Semaglutide versus dummy treatment (placebo) in patients with Alcohol Use Disorder (AUD) and Obesity (Ob) to assess if these doses improve alcohol craving, stress and alcohol use outcomes.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.723Z"},{"nctId":"NCT07774481","title":"Anxiety Skills Study","officialTitle":"Personalizing and Optimizing CBT Skills for Anxiety","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Ohio State University","sponsorClass":"OTHER","summary":"The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.","conditions":["Anxiety","Anxiety Acute","Anxiety Chronic","Anxiety and Mood Disorders","Social Anxiety Disorder","Panic Disorder (With or Without Agoraphobia)","Generalized Anxiety Disorder","Obsessive-Compulsive Disorder","Specific Phobia"],"keywords":["anxiety","CBT","treatment"],"interventions":[{"type":"BEHAVIORAL","name":"Cognitive therapy"},{"type":"BEHAVIORAL","name":"Behavioral therapy"},{"type":"BEHAVIORAL","name":"Mindfulness-based therapy"}],"enrollment":600,"startDate":"2025-10-20","completionDate":"2029-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Presence of clinically elevated anxiety\n* Living in Ohio\n\nExclusion Criteria:\n\n* No access to a smartphone\n* Presence of conditions that would necessitate alternative care","locations":[{"facility":"Psychology Building at Ohio State University","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Coordinator, PhD","phone":"614-398-1624","email":"anxietyskillsstudy@gmail.com"}],"primaryOutcomes":["Overall Anxiety Severity and Impairment Scale (OASIS)"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Cognitive therapy for Anxiety","inPlainEnglish":"The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.","whoItsFor":["Ages 18 Years to any","Presence of clinically elevated anxiety"],"whoShouldSkip":["No access to a smartphone","Presence of conditions that would necessitate alternative care"],"whatHappens":"If you join, the listed intervention(s) are Cognitive therapy, Behavioral therapy, or Mindfulness-based therapy. The registry lists allocation as randomized. The purposes of this study are: (1) to identify baseline predictors of relative success in cognitive, behavioral, and mindfulness-based treatments for anxiety, (2) explore who benefits from a brief, video-based skill training compared to receiving 4 sessions of therapy, and (3) to evaluate how durable these effects are over 1 year.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 600 people at Columbus. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.356Z"},{"nctId":"NCT07775404","title":"A Study to Investigate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus","officialTitle":"A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Evaluate the Efficacy and Safety of Elecoglipron in Asian Participants With Obesity or Overweight With or Without Type 2 Diabetes Mellitus (EMBOLD-Asia)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of elecoglipron compared with placebo adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.","conditions":["Obesity","Overweight"],"keywords":["elecoglipron","AZD5004","ECC5004","GLP-1 receptor agonist","Weight loss","Weight management","Type 2 diabetes mellitus"],"interventions":[{"type":"DRUG","name":"Elecoglipron"},{"type":"DRUG","name":"Placebo"}],"enrollment":351,"startDate":"2026-08-21","completionDate":"2028-04-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult participant aged 18 years or older at the time of informed consent.\n* Body mass index (BMI) at screening of:\n* 28 kg/m\\^2 or higher, or\n* 24 kg/m\\^2 to less than 28 kg/m\\^2 with at least 1 weight-related comorbidity.\n* Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)\n* History of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n* Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening.\n\nExclusion Criteria:\n\n* Any of the following medical history, laboratory values, or complications related to diabetes:\n* T1DM\n* HbA1c ≥ 10% (86 mmol/mol) at the screening visit\n* Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema.\n* Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis.\n* History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2.","locations":[{"facility":"Research Site","city":"Baotou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changde","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changsha","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hefei","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huangshi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jincheng","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinzhou Shi","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Langfang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Luoyang","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Meihekou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shantou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shijiazhuang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhu","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xianyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xuzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yan’an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yueyang","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhumadian","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zibo","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shatin, Hong Kong","state":"","country":"Hong Kong","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Alor Star","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kuala Lumpur","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kuching","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Putrajaya","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sarawak Miri","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Seremban","state":"","country":"Malaysia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Seri Manjung","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Sungai Buloh","state":"","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Davao City","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Iloilo City","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Manila","state":"","country":"Philippines","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bangkok","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chiang Mai","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Phutthamonthon","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Songkhla","state":"","country":"Thailand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Percent change from baseline to Week 52 in body weight","Participants achieving at least 5% body weight loss at Week 52"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["baotou-china","beijing-china","changde-china","changsha-china","changzhou-china","chengdu-china","hefei-china","huangshi-china","jincheng-china","jinzhou-shi-china","langfang-china","luoyang-china","meihekou-china","nanjing-china","nanyang-china","shanghai-china","shantou-china","shenyang-china","shijiazhuang-china","wuhan-china","wuhu-china","xianyang-china","xuzhou-china","yanan-china","yueyang-china","zhumadian-china","zibo-china","hong-kong-hong-kong","shatin-hong-kong-hong-kong","alor-star-malaysia","kuala-lumpur-malaysia","kuching-malaysia","putrajaya-malaysia","sarawak-miri-malaysia","seremban-malaysia","seri-manjung-malaysia","sungai-buloh-malaysia","davao-city-philippines","iloilo-city-philippines","manila-philippines","bangkok-thailand","chiang-mai-thailand","phutthamonthon-thailand","songkhla-thailand"],"enrichment":{"headline":"Phase 3: testing Elecoglipron for Obesity","inPlainEnglish":"This study wants to measure the how well it works and safety of elecoglipron compared with dummy treatment (placebo) adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.","whoItsFor":["Ages 18 Years to any","Body mass index (body-mass index (BMI)) at screening of:","28 kg/m\\^2 or higher, or","24 kg/m\\^2 to less than 28 kg/m\\^2 with at least 1 weight-related comorbidity","Stable body weight (self-reported or documented) for 90 days prior to the screening visit (± 5% body weight change)","History of at least 1 self-reported unsuccessful dietary effort to lose body weight","Participants with type 2 diabetes mellitus, if enrolled, and have HbA1c from 6.5% to less than 10.0% at screening"],"whoShouldSkip":["Any of the following medical history, laboratory values, or complications related to diabetes:","HbA1c ≥ 10% (86 mmol/mol) at the screening visit","Currently receiving, or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema","Have had more than one episode of severe hypoglycemia within 180 days prior to the screening visit, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms","History of acute (unless due to previously resolved gallstone pancreatitis and post-cholecystectomy) or chronic pancreatitis","History/family history (first degree biologic relatives) of medullary thyroid cancer or multiple endocrine neoplasia type 2"],"whatHappens":"If you join, the listed intervention(s) are Elecoglipron, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works and safety of elecoglipron compared with dummy treatment (placebo) adjunct to diet and exercise for weight management, in adult participants living with obesity or overweight with or without T2DM.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 351 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.515Z"},{"nctId":"NCT07775534","title":"Tear Fluid for the Detection of Tumor-associated Extracellular Vesicles in Glioblastoma Patients","officialTitle":"Molecular Analysis of Tear Fluid Collected From Glioblastoma Patients: A Two-Phased Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"City of Hope Medical Center","sponsorClass":"OTHER","summary":"This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma. Brain tumors release small particles, called TEVs, that may provide information about the tumor, including how it responds to treatment. These particles can be found in cerebrospinal fluid (CSF), which is the fluid that surrounds the brain and spinal cord. Collecting CSF can be difficult and expensive, especially if samples are needed frequently to track these particles over time. Tear fluid is easier to collect than spinal fluid. If tears are found to contain similar tumor-related particles, changes in the tumor may be tracked by studying the particles found in tear fluid.","conditions":["Glioblastoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"OTHER","name":"Electronic Health Record Review"},{"type":"OTHER","name":"Questionnaire Administration"}],"enrollment":30,"startDate":"2026-10-23","completionDate":"2029-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults (age ≥ 18)\n* Male and female\n* All racial and ethnic groups\n* Pathologically-proven diagnosis of GBM or healthy volunteers\n* For GBM patients, presence of a previously placed Rickham reservoir or shunt\n* Able to provide informed consent (or via legal representative)\n* Willing to undergo Schirmer strip procedure\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation\n* Recent ocular surgery (within 3 months)\n* Chronic dry eyes\n* Known allergy or hypersensitivity to topical anesthetics\n* Cognitive impairment\n* Pregnancy\n* Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk","locations":[{"facility":"City of Hope Medical Center","city":"Duarte","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Proportion of samples containing at least 2 uL of tear (feasibility)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["duarte-california"],"enrichment":{"headline":"Not a traditional drug phase: Biospecimen Collection for Glioblastoma","inPlainEnglish":"This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma. Brain tumors release small particles, called TEVs, that may provide information about the tumor, including how it responds to treatment.","whoItsFor":["Ages 18 Years to any","All racial and ethnic groups","Pathologically-proven diagnosis of GBM or healthy volunteers","For GBM patients, presence of a previously placed Rickham reservoir or shunt","Willing to undergo Schirmer strip procedure"],"whoShouldSkip":["Active ocular infection or inflammation","Recent ocular surgery (within 3 months)","Known allergy or hypersensitivity to topical anesthetics","Cognitive impairment","Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study procedures or place the participant at undue risk"],"whatHappens":"If you join, the listed intervention(s) are Biospecimen Collection, Biospecimen Collection, or Electronic Health Record Review. The registry lists allocation as randomized. This clinical trial tests the impact of tear fluid in detecting tumor-associated extracellular vesicles (TEVs) in patients with glioblastoma.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Duarte. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.483Z"},{"nctId":"NCT07775846","title":"QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy","officialTitle":"QUAdruple Therapy With RASi, Empagliflozin, Finerenone, and Mazdutide in Type 2 Diabetes and Early Treatment of Nephropathy(QUARTET-DKD)","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Huijie Zhang","sponsorClass":"OTHER","summary":"This study employs a prospective, randomized, double-blind, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all participants will be randomized in a 1:1:1:1 ratio into four treatment groups:\n\nGroup 1 (G1): ARB + empagliflozin + finerenone placebo + mazdutide placebo; Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide placebo; Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone placebo; Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone. The primary comparisons include G2 vs. G1, G3 vs. G1, G4 vs. G2, and G4 vs. G3, designed to evaluate the superiority of triple therapy over dual therapy, and quadruple therapy over triple therapy, in reducing the urine albumin-to-creatinine ratio (UACR).","conditions":["Type 2 Diabetic Kidney Disease"],"keywords":["SGLT2 inhibitors","Mineralocorticoid receptor antagonists","GLP-1 receptor agonists","Randomized controlled trial","angiotensin II receptor blocker","urinary albumin-to-creatinine ratio"],"interventions":[{"type":"DRUG","name":"empagliflozin"},{"type":"DRUG","name":"Finerenone"},{"type":"DRUG","name":"Mazdutide"},{"type":"DRUG","name":"Finerenone Placebo"},{"type":"DRUG","name":"Mazdutide Placebo"},{"type":"DRUG","name":"Angiotensin Receptor Blocker (ARB)"}],"enrollment":820,"startDate":"2026-11-03","completionDate":"2029-02-28","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM).\n* Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period.\n* Body Mass Index (BMI) ≥ 24.0 kg/m2.\n* Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and \\< 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days.\n* Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2.\n* Serum potassium level ≤ 4.8 mmol/L.\n* Glycated hemoglobin (HbA1c) \\< 11%.\n* Voluntarily understood and signed the written Informed Consent Form (ICF).\n\nExclusion Criteria:\n\n* Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc).\n* Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2).\n* History of severe acute or chronic pancreatitis.\n* History of diabetic ketoacidosis (DKA).\n* Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) \\< 110 mmHg.\n* Refractory hypertension, defined as a resting SBP \\> 170 mmHg despite the concurrent use of three antihypertensive medications.\n* History of severe dehydration, severe diarrhea, or acute volume depletion within 30 days prior to screening.\n* History of acute kidney injury (AKI) within 30 days prior to screening.\n* Use of traditional Chinese medicines with potential proteinuria-lowering effects (e.g., Keluoxin capsules, Huangkui capsules, or Shenyan Kangfu tablets) within 30 days prior to screening.\n* Use of potassium-sparing diuretics (e.g., triamterene or amiloride) or mineralocorticoid receptor antagonists (e.g., spironolactone, eplerenone, or finerenone) within 2 months prior to screening.\n* Use of GLP-1 receptor agonists, GLP-1/GIP dual receptor agonists, or GLP-1/glucagon (GCG) dual receptor agonists within 6 months prior to screening.\n* Current use of strong CYP3A4 inhibitors (e.g., itraconazole or clarithromycin) or CYP3A4 inducers that may significantly interfere with finerenone metabolism.\n* Myocardial infarction, unstable angina, stroke, or hospitalization due to heart failure (NYHA Class III-IV) within 3 months prior to screening.\n* Active urogenital tract infection, or a history of urogenital tract infection associated with the prior use of SGLT2 inhibitors.\n* Women who are pregnant, planning to become pregnant, or lactating.\n* Inability to complete the 6-month follow-up due to general health conditions or geographic relocation.\n* Any other condition that, in the opinion of the investigator, renders the participant unsuitable for participation in the study.","locations":[{"facility":"Zhongshan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"jingjing jiang, PhD","phone":"13402003919","email":"jiang.jingjing@zs-hospital.sh.cn"}],"primaryOutcomes":["Relative Change From Baseline in Urine Albumin-to-Creatinine Ratio (UACR) at Month 6"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["empagliflozin"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 4: testing empagliflozin for Type 2 Diabetic Kidney Disease","inPlainEnglish":"This study employs a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria. With an angiotensin receptor blocker (ARB) as the background therapy, all you would be randomly assigned in a 1:1:1:1 ratio into four treatment groups: Group 1 (G1): ARB + empagliflozin + finerenone dummy treatment (placebo) + mazdutide dummy treatment (placebo); Group 2 (G2): ARB + empagliflozin + finerenone + mazdutide dummy treatment (placebo); Group 3 (G3): ARB + empagliflozin + mazdutide + finerenone dummy treatment (placebo); Group 4 (G4): ARB + empagliflozin + mazdutide + finerenone.","whoItsFor":["Ages 18 Years to 70 Years","Age ≥18 years, with a confirmed diagnosis of type 2 diabetes mellitus (T2DM)","Receiving a standard dose of an Angiotensin-Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) therapy for at least 4 consecutive weeks prior to screening, with the dose expected to remain stable throughout the study period","Body Mass Index (body-mass index (BMI)) ≥ 24.0 kg/m2","Mean urine albumin-to-creatinine ratio (UACR) ≥ 100 mg/g and \\< 5000 mg/g, calculated from first morning void urine samples collected over 3 consecutive days","Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥ 30 mL/min/1.73m2","Serum potassium level ≤ 4.8 mmol/L","Glycated hemoglobin (HbA1c) \\< 11%"],"whoShouldSkip":["Definite diagnosis of non-diabetic kidney disease (e.g., IgA nephropathy, polycystic kidney disease, lupus nephritis, etc)","Personal or family history of medullary thyroid carcinoma (MTC), or a diagnosis of multiple endocrine neoplasia syndrome type 2 (MEN 2)","History of severe acute or chronic pancreatitis","History of diabetic ketoacidosis (DKA)","Symptomatic hypotension during the screening period, or a resting systolic blood pressure (SBP) \\< 110 mmHg","Refractory hypertension, defined as a resting SBP \\> 170 mmHg despite the concurrent use of three antihypertensive medications","History of severe dehydration, severe diarrhea, or acute volume depletion within 30 days prior to screening"],"whatHappens":"If you join, the listed intervention(s) are empagliflozin, Finerenone, or Mazdutide. The registry lists allocation as randomized. This study employs a prospective, randomly assigned, neither you nor the study doctors know who gets the real treatment, parallel-controlled design, aiming to enroll adult participants with type 2 diabetic kidney disease (DKD) who meet the eligibility criteria.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 820 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.513Z"},{"nctId":"NCT07776054","title":"Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent AF With HFpEF","officialTitle":"Clinical Impact of SGLT2 Inhibitor After DC Cardioversion in Persistent Atrial Fibrillation Patients With Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Samsung Medical Center","sponsorClass":"OTHER","summary":"SGLT2 inhibitors improve outcomes in heart failure across the ejection fraction spectrum, but their effect on maintenance of sinus rhythm after rhythm-control therapy is largely unknown. This prospective, single-center, open-label randomized controlled trial evaluates whether an SGLT2 inhibitor started after successful electrical cardioversion reduces recurrence of atrial tachyarrhythmia at 1 month in patients with persistent atrial fibrillation and heart failure with preserved ejection fraction. 200 patients will be randomized 1:1 to receive an SGLT2 inhibitor or no SGLT2 inhibitor.","conditions":["Atrial Fibrillation","SGLT2 Inhibitor","DC Cardioversion"],"keywords":[],"interventions":[{"type":"DRUG","name":"SGLT2 inhibitors (Dapagliflozin and Empagliflozin)"}],"enrollment":200,"startDate":"2024-02-01","completionDate":"2027-08-01","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥19 years\n* Persistent atrial fibrillation\n* H2FPEF score ≥6 or HFA-PEFF score ≥5\n* Restoration of sinus rhythm after electrical cardioversion\n\nExclusion Criteria:\n\n* Previous use of an SGLT2 inhibitor\n* Intracardiac thrombus on transesophageal echocardiography\n* Refusal to participate","locations":[{"facility":"Samsung Medical Center","city":"Seoul","state":"Seoul","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juwon Kim","phone":"+82-2-3410-2578","email":"abcd186a@naver.com"}],"primaryOutcomes":["Recurrence of atrial tachyarrhythmia"],"hasResults":false,"conditionSlugs":["heart-failure","atrial-fibrillation"],"drugSlugs":["empagliflozin","dapagliflozin"],"locationSlugs":["seoul-south-korea"],"enrichment":{"headline":"Phase 4: testing SGLT2 inhibitors (Dapagliflozin and Empagliflozin) for Atrial Fibrillation","inPlainEnglish":"SGLT2 inhibitors improve outcomes in heart failure across the ejection fraction spectrum, but their effect on maintenance of sinus rhythm after rhythm-control therapy is largely unknown. This prospective, single-center, open-label randomly assigned controlled trial evaluates whether an SGLT2 inhibitor started after successful electrical cardioversion reduces recurrence of atrial tachyarrhythmia at 1 month in patients with persistent atrial fibrillation and heart failure with preserved ejection fraction.","whoItsFor":["Ages 19 Years to any","Persistent atrial fibrillation","H2FPEF score ≥6 or HFA-PEFF score ≥5","Restoration of sinus rhythm after electrical cardioversion"],"whoShouldSkip":["Previous use of an SGLT2 inhibitor","Intracardiac thrombus on transesophageal echocardiography","Refusal to participate"],"whatHappens":"If you join, the listed intervention(s) are SGLT2 inhibitors (Dapagliflozin and Empagliflozin). The registry lists allocation as randomized. SGLT2 inhibitors improve outcomes in heart failure across the ejection fraction spectrum, but their effect on maintenance of sinus rhythm after rhythm-control therapy is largely unknown.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 200 people at Seoul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.621Z"},{"nctId":"NCT07776509","title":"A Study to Evaluate Effect of AZD6234 as an Adjunct to Incretin-based Therapies in Adult Participants With Obesity or Overweight With Weight-related Comorbidity With or Without Type 2 Diabetes Mellitus","officialTitle":"A Phase III Randomised, Double-Blind, Placebo-Controlled Multicentre Trial to Evaluate the Efficacy and Safety of AZD6234 as an Adjunct to Incretin-based Therapies in Participants With Obesity or Overweight With at Least One Weight-Related Comorbidity With or Without Type 2 Diabetes Mellitus (SELENE 3)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. Efficacy of AZD6234 will be compared to placebo in percent body weight change from baseline at 68 weeks of treatment.","conditions":["Obesity or Overweight","Weight-Related Comorbidity","With/Without Diabetes Mellitus, Type 2"],"keywords":["Obesity","Overweight","AZD6234","Lenbelintide","Diabetes Mellitus, Type 2"],"interventions":[{"type":"DRUG","name":"Lenbelintide"},{"type":"DRUG","name":"Placebo"}],"enrollment":500,"startDate":"2026-08-24","completionDate":"2028-08-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Males \\& females (inclusive of all gender identities) age ≥18 years\n* BMI ≥ 30 kg/m2 OR BMI ≥ 27 kg/m2 with at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea, cardiovascular disease, heart failure, chronic kidney disease, metabolic dysfunction associated steatotic liver disease, osteoarthritis of the knee, or stress urinary incontinence\n* For participants with T2DM only:\n\n  * Diagnosed with T2DM ≥ 90 days prior to Screening\n  * HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication\n* Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation.\n* Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation\n* History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime\n\nExclusion Criteria:\n\n* Obesity primarily caused by other endocrine disorders\n* Type 1 diabetes mellitus\n* Significant hepatobiliary disease and/or any of the following results at Screening:\n\n  * ALT ≥ 3.0 × ULN\n  * AST ≥ 3.0 × ULN\n  * TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)\n* Use of insulin therapy for T2DM within 3 months prior to screening","locations":[{"facility":"Research Site","city":"Escondido","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lincoln","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Walnut Creek","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Stockbridge","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Champaign","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beltsville","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Oxon Hill","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kansas City","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Somerset","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Statesville","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Smithfield","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Franklin","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Manassas","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Renton","state":"Washington","country":"United States","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"CABA","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ciudad de Buenos Aires","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ramos Mejía","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rosario","state":"","country":"Argentina","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"San Nicolás","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Belo Horizonte","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Campinas","state":"","country":"Brazil","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Surrey","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guelph","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Stouffville","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Toronto","state":"Ontario","country":"Canada","status":"WITHDRAWN","lat":null,"lon":null},{"facility":"Research Site","city":"Joliette","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changchun","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Huzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ningbo","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Aarhus N","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Gandrup","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Herlev","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Holbæk","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hvidovre","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Middelfart","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Odense","state":"","country":"Denmark","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Vejle","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Holon","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jerusalem","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kfar Saba","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Petah Tikva","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chūōku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ichinomiya-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Izunokuni-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kamakura-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kawagoe-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kitakyushu-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kyoto","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Mito","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nishinomiya-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ōmihachiman","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Yokohama","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Linköping","state":"","country":"Sweden","status":"SUSPENDED","lat":null,"lon":null},{"facility":"Research 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(Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Airdrie","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chippenham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hull","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Llandough","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rotherham","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Percent change in body weight from baseline at 68 weeks of treatment"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["escondido-california","lincoln-california","walnut-creek-california","jacksonville-florida","stockbridge-georgia","woodstock-georgia","champaign-illinois","chicago-illinois","beltsville-maryland","oxon-hill-maryland","kansas-city-missouri","las-vegas-nevada","somerset-new-jersey","statesville-north-carolina","fargo-north-dakota","columbus-ohio","portland-oregon","smithfield-pennsylvania","franklin-tennessee","houston-texas","manassas-virginia","renton-washington","buenos-aires-argentina","caba-argentina","ciudad-de-buenos-aires-argentina","ramos-mej-a-argentina","rosario-argentina","san-nicol-s-argentina","belo-horizonte-brazil","campinas-brazil","s-o-paulo-brazil","calgary-canada","surrey-canada","vancouver-canada","guelph-canada","hamilton-canada","stouffville-canada","toronto-canada","joliette-canada","montreal-canada","beijing-china","changchun-china","chengdu-china","guangzhou-china","huzhou-china","nanjing-china","ningbo-china","aarhus-n-denmark","gandrup-denmark","herlev-denmark","holb-k-denmark","hvidovre-denmark","middelfart-denmark","odense-denmark","vejle-denmark","holon-israel","jerusalem-israel","kfar-saba-israel","petah-tikva-israel","tel-aviv-israel","ch-ku-japan","ichinomiya-shi-japan","izunokuni-shi-japan","kamakura-shi-japan","kawagoe-shi-japan","kitakyushu-shi-japan","kyoto-japan","mito-japan","nishinomiya-shi-japan","mihachiman-japan","yokohama-japan","link-ping-sweden","lund-sweden","m-lndal-sweden","rebro-sweden","stockholm-sweden","ankara-turkey-t-rkiye","antalya-turkey-t-rkiye","center-turkey-t-rkiye","istanbul-turkey-t-rkiye","airdrie-united-kingdom","chippenham-united-kingdom","hull-united-kingdom","llandough-united-kingdom","rotherham-united-kingdom"],"enrichment":{"headline":"Phase 3: testing Lenbelintide for Obesity or Overweight","inPlainEnglish":"The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity. how well it works of AZD6234 will be compared to dummy treatment (placebo) in percent body weight change from baseline at 68 weeks of treatment.","whoItsFor":["Ages 18 Years to any","Males \\& females (inclusive of all gender identities) age ≥18 years","For participants with T2DM only:","Diagnosed with T2DM ≥ 90 days prior to Screening","HbA1c value at Screening of ≥6.0% (42 mmol/mol) and ≤9.0% (75 mmol/mol) managed with diet and exercise alone or with a stable dose of any oral glycaemic-lowering agent and/or incretin-based medication","Receiving a stable dose of incretin- based medications at a dose level that is sufficient for chronic weight management for at least 3 months prior to Screening and Randomisation","Stable body weight (≤ 3% body weight change) for at least 3 months prior to Randomisation","History of at least one self-reported unsuccessful attempt to lose body weight in their lifetime"],"whoShouldSkip":["Obesity primarily caused by other endocrine disorders","Type 1 diabetes mellitus","Significant hepatobiliary disease and/or any of the following results at Screening:","TBL \\> 1.5 × ULN (except for cases of known Gilbert's Syndrome)","Use of insulin therapy for T2DM within 3 months prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Lenbelintide, or Placebo. The registry lists allocation as randomized. The study will evaluate how well AZD6234 works and how safe it is in adults with excess weight or obesity.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 500 people at 85 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.522Z"},{"nctId":"NCT07776574","title":"Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function","officialTitle":"Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Charles University, Czech Republic","sponsorClass":"OTHER","summary":"Endometriosis is a chronic estrogen-dependent disease characterized by the presence and growth of endometrium-like tissue outside the uterine cavity.\n\nThis ectopic endometrial tissue induces a chronic local and systemic inflammatory response, resulting in the most common manifestations of the disease: chronic pelvic pain, infertility, and pelvic adhesions. In deep endometriosis (DE), adhesions and infiltrative growth may damage adjacent organs.\n\nOverall, endometriosis affects approximately 10% of women of reproductive age. Its prevalence is higher among women with infertility (20-50%) and among patients with chronic pelvic pain (up to 90%).\n\nThe disease is usually categorized as superficial peritoneal, ovarian, or deep endometriosis (DE). Deep endometriosis is a progressive form of the disease that may affect organs beyond the pelvic cavity, including the urinary tract, alter their anatomy, and cause functional impairment.\n\nUrogenital involvement occurs in approximately 1-5.5% of all women with endometriosis; the prevalence is substantially higher among patients with DE, reaching 16-53% according to the available literature.\n\nWithin the urinary tract, the bladder is most commonly affected (70-85%), followed by the ureters (9-23%), kidneys (approximately 4%), and urethra (approximately 2%).\n\nUreteral endometriosis is therefore a relatively rare but clinically significant entity. It may be unilateral or bilateral, with a predominance of left-sided involvement.\n\nTwo basic forms are distinguished:\n\n* \"Extrinsic\" - ureteral stenosis caused by periureteral fibrosis and the presence of DE lesions without infiltration of the ureteral wall.\n* \"Intrinsic\" - ureteral stenosis caused by direct infiltration of the ureteral wall by endometriotic tissue.\n\nUreteral stenosis causes secondary hydronephrosis and, unless treated in a timely manner, may lead to a progressive loss of renal function.\n\nThe disease frequently remains asymptomatic for a prolonged period. Up to half of cases are diagnosed incidentally or only at an advanced stage, when renal damage is already irreversible.\n\nEarly detection and timely planning of surgical management are therefore essential for preserving renal function.\n\nThe main surgical procedures are:\n\n* ureterolysis - release of the ureter from fibrotic adhesions, preferred for the extrinsic form;\n* ureteroneocystostomy (UCNA) - indicated for the intrinsic form when the affected segment must be resected and the ureter reimplanted into the bladder;\n* ureteroureterostomy (ureteral anastomosis) - appropriate for the intrinsic form when, following resection, the distal ureteral segment is sufficiently long to allow anastomosis of healthy margins.\n\nDespite the clinical significance of the condition, prospective studies objectively evaluating the evolution of renal function after the individual types of surgical management of ureteral endometriosis are still lacking.\n\nA modern diagnostic strategy combining specialized ultrasound, dynamic renal scintigraphy (MAG3), and analysis of urinary biomarkers of tubular injury (KIM-1, CCL-2, L-FABP) enables earlier detection of renal dysfunction and more accurate monitoring of postoperative recovery. Identification of sensitive biomarkers of early renal injury and validation of an algorithm for their use could substantially improve decisions regarding the timing of surgery and subsequent postoperative follow-up.\n\nBased on our experience, some patients surgically treated for hydronephrosis caused by DE-related ureteral stenosis show persistent morphological changes on renal ultrasound and the manifestation of systemic conditions such as arterial hypertension during long-term follow-up. To date, no study has focused on the long-term follow-up of patients with ureteral DE and its potential consequences. The expected benefit of this study is to establish clear criteria for the indication of surgical treatment of ureteral endometriosis and to develop an evidence-based protocol for long-term follow-up.","conditions":["Endometriosis","Endometriosis (Diagnosis)","Urinary Tract Diseases"],"keywords":["deep infiltrated endometriosis","ureteral endometriosis","nephrectomy"],"interventions":[],"enrollment":20,"startDate":"2026-04-01","completionDate":"2029-01-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:• age ≥ 18 years;\n\n* hydronephrosis caused by DE-related ureteral stenosis;\n* for Group F: a history of surgical treatment of ureteral endometriosis (ureterolysis, ureteroureterostomy, UCNA) at our center at least 24 months previously;\n* for Group S: indication for surgical treatment because of hydronephrosis or clinically significant ureteral stenosis;\n* signed informed consent.\n\nExclusion Criteria:• pregnancy;\n\n* malignancy;\n* congenital uropathy;\n* other renal diseases;\n* inability to undergo dynamic renal scintigraphy (e.g., allergy to the radiopharmaceutical or severe comorbidities precluding the examination);\n* previous urinary tract surgery unrelated to ureteral endometriosis that could substantially confound the assessment of renal function.","locations":[{"facility":"General University in Prague","city":"Prague","state":"","country":"Czechia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kristýna HLinecká, MD PhD","phone":"+420605413210","email":"Kristyna.Hlinecka2@vfn.cz"}],"primaryOutcomes":["The project will comprise two complementary components: Group F (long-term follow-up of patients at least 2 years after surgery) and Group S (the pilot component of the project - patients assessed before surgery).","Hydronephrosis Grade Assessed by Renal Ultrasound","Intrarenal Arterial Peak Systolic Velocity Measured by Pulsed-Wave Doppler Ultrasound","Intrarenal Arterial End-Diastolic Velocity Measured by Pulsed-Wave Doppler Ultrasound","Intrarenal Arterial Resistive Index Measured by Pulsed-Wave Doppler Ultrasound"],"hasResults":false,"conditionSlugs":["endometriosis","hypertension"],"drugSlugs":[],"locationSlugs":["prague-czechia"],"enrichment":{"headline":"Deep Endometriosis Affecting the Urogenital Tract: Long-term Outcomes and Impact on Renal Function","inPlainEnglish":"Endometriosis is a chronic estrogen-dependent disease characterized by the presence and growth of endometrium-like tissue outside the uterine cavity. This ectopic endometrial tissue induces a chronic local and systemic inflammatory response, resulting in the most common manifestations of the disease: chronic pelvic pain, infertility, and pelvic adhesions.","whoItsFor":["Ages 18 Years to any","Women only","hydronephrosis caused by DE-related ureteral stenosis;","for Group F: a history of surgical treatment of ureteral endometriosis (ureterolysis, ureteroureterostomy, UCNA) at our center at least 24 months previously;","for Group S: indication for surgical treatment because of hydronephrosis or clinically significant ureteral stenosis;"],"whoShouldSkip":["congenital uropathy;","other renal diseases;","inability to undergo dynamic renal scintigraphy (e.g., allergy to the radiopharmaceutical or severe comorbidities precluding the examination);","previous urinary tract surgery unrelated to ureteral endometriosis that could substantially confound the assessment of renal function"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20 people at Prague. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.116Z"},{"nctId":"NCT07776691","title":"A Study of Raludotatug Deruxtecan With or Without Bevacizumab as First-Line Maintenance Treatment in Non-HRD-Positive Advanced Ovarian Cancer (MK-5909-006, (ENGOT-ov102/GOG-3141/ REJOICE-Ovarian 04)","officialTitle":"A Phase 3, Randomized, Open-label Study of Raludotatug Deruxtecan (MK-5909, R-DXd) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly-Diagnosed Advanced Non-HRD-Positive Ovarian Cancer Following First-line Platinum-based Chemotherapy (ENGOT-ov102/MITO/GOG-3141/ REJOICE-Ovarian 04)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include:\n\nMaintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread.\n\nObservation, which is watching to see if cancer grows or worsens. The study medicine, raludotatug deruxtecan- R-DXd, is a targeted therapy. The goal of this study is to learn if people who receive R-DXd maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.","conditions":["Ovarian Cancer","Ovarian Neoplasms","Peritoneal Cancer","Fallopian Tube Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"R-DXd"},{"type":"DRUG","name":"Bevacizumab"}],"enrollment":802,"startDate":"2026-09-18","completionDate":"2032-03-19","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer\n* Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)\n* Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol\n* Has provided tumor tissue that is not previously irradiated\n* Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has non-serous or non-endometrioid high-grade epithelial histology, nonepithelial ovarian cancers, borderline tumors, mucinous tumor, seromucinous tumor that is predominately mucinous, malignant Brenner's tumor, and undifferentiated carcinoma\n* Has received 1L platinum-based chemotherapy without bevacizumab and have a response of SD or PR at the time of screening\n* Has received prior systemic anticancer therapy, with the exception of the first-line platinum-based chemotherapy required by the inclusion criteria\n* Has not recovered from major surgery or has ongoing surgical complications\n* Has a homologous recombination deficiency (HRD)-positive, unknown, or inconclusive tumor status as determined by the central laboratory\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder or prior pneumonectomy\n* Has current, clinically relevant bowel obstruction including obstruction related to underlying EOC, abdominal fistula or gastrointestinal perforation, intra-abdominal abscess, or evidence of rectosigmoid involvement by pelvic exam\n* HIV-infected participants with a history of Kaposi's sarcoma and/or multicentric Castleman disease\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Has active infection requiring systemic therapy","locations":[{"facility":"MedStar Washington Hospital Center ( Site 0026)","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lahey Hospital & Medical Center ( Site 0031)","city":"Burlington","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8000)","city":"Eugene","state":"Oregon","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - West Texas ( Site 8009)","city":"Amarillo","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Central/South Texas ( Site 8002)","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - DFW ( Site 8005)","city":"Fort Worth","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Oncology - Northeast Texas ( Site 8004)","city":"Tyler","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus ( Site 1402)","city":"Haifa","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sourasky Medical Center ( Site 1403)","city":"Tel Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Hospital ( Site 2301)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Samsung Medical Center ( Site 2303)","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Cheng Kung University Hospital ( Site 2601)","city":"Tainan","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Lancaster Infirmary ( Site 2808)","city":"Lancaster","state":"Lancashire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Progression-Free Survival (PFS)","Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia","burlington-massachusetts","eugene-oregon","amarillo-texas","austin-texas","fort-worth-texas","tyler-texas","haifa-israel","tel-aviv-israel","seoul-south-korea","tainan-taiwan","lancaster-united-kingdom"],"enrichment":{"headline":"Phase 3: testing R-DXd for Ovarian Cancer","inPlainEnglish":"Researchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible.","whoItsFor":["Ages 18 Years to any","Women only","The main who can join include but are not limited to the following:","Has a new, histologically confirmed diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or Stage IV epithelial ovarian cancer (EOC) (high grade serous or high grade endometrioid), fallopian tube cancer, or primary peritoneal cancer","Has undergone primary debulking surgery (PDS) or interval debulking surgery (IDS)","Has completed first-line (1L) platinum-based chemotherapy, with a response of stable disease, partial response, complete response or no evidence of disease per protocol","Has provided tumor tissue that is not previously irradiated","Who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (except alopecia or vitiligo), as assessed by the physician investigator","Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are R-DXd, or Bevacizumab. The registry lists allocation as randomized. Researchers are looking for new ways to treat ovarian cancer (OC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 802 people at 13 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.182Z"},{"nctId":"NCT07777575","title":"Resistance Training to Prevent Muscle Loss During Treatment With Tirzepatide","officialTitle":"A Phase IV, Randomized Controlled Trial to Evaluate the Effects of Resistance Training Versus Usual Care on Thigh Muscle Volume During Treatment With the Dual GIP/GLP-1 Receptor Agonist Tirzepatide in Adults With Obesity","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Technical University of Munich","sponsorClass":"OTHER","summary":"Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects. The aim of this clinical trial is to examine the effects of resistance training versus standard of care on contractile thigh muscle volume in patients receiving the dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonists 'tirzepatide'.","conditions":["Obesity (BMI>30)"],"keywords":["skeletal muscle","weight loss","exercise training","strength training","incretin-based therapy"],"interventions":[{"type":"DRUG","name":"Dual GIP/GLP-1 Receptor Agonist Tirzepatide"},{"type":"BEHAVIORAL","name":"Resistance Training"}],"enrollment":150,"startDate":"2026-10-07","completionDate":"2027-08-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAge\n\n1. Are ≥ 18 years and ≤ 60 years of age\n\n   Weight\n2. Have a body mass index (BMI) of ≥ 30 kg/m2\n3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight\n4. In the investigator's opinion, are well motivated, capable, and willing to\n\n   * learn how to self-inject the investigational medicinal product (IMP), as required for this protocol\n   * inject the IMP, and\n   * comply with trial procedures for the duration of the trial, including adherence to scheduled visits, the prescribed resistance training program (if assigned to the experimental group), lifestyle recommendations, and other requirements as specified in the protocol\n\n   Sex and contraceptive/barrier requirements \\[only for women\\]\n5. Women of childbearing potential (WOCBP) may be enrolled only if one of the following applies:\n\n   * They are completely abstinent as their preferred and usual lifestyle or exclusively in a same-sex relationship as their preferred and usual lifestyle and agree to remain abstinent or stay in a same-sex relationship without sexual relationships with males until 30 days after the last injection (\\> 5 half-lives of tirzepatide)\n   * They have a negative serum pregnancy test result at screening followed by a negative urine result ≤ 24 hours prior to the first injection, and they agree to use, from screening until 30 days after the last injection, either:\n   * one highly effective method of contraception (failure rate \\<1% per year) or\n   * two complementary forms of effective contraception Note: The summary of product characteristics (SmPC) indicates that concomitant use with tirzepatide may reduce systemic exposure to oral contraceptives, particularly during dose escalation, potentially decreasing their contraceptive effectiveness. Therefore, the use of a barrier method in combination with oral contraceptives is required.\n\n   Informed Consent\n6. Are sufficiently proficient in German to understand the trial procedures and informed consent information\n7. Are capable of providing written informed consent\n\nExclusion Criteria:\n\nMedical Conditions Diabetes Related\n\n1. Have known Type 1 Diabetes, a history of Type 2 Diabetes (including those in remission), a history of ketoacidosis of any aetiology, or a history of hyperosmolar hyperglycaemic state or coma\n2. Have at least one laboratory value suggestive of diabetes during screening including:\n\n   * glycated hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol)\n   * fasting glucose ≥126 mg/dL (≥7.0 mmol/L) Note: If a blood sample is collected under non-fasting conditions and the random glucose value is ≥200 mg/dL (≥11.1 mmol/L), an additional fasting blood sample will be obtained to confirm or exclude diabetes.\n\n   Obesity Related\n3. Have a self-reported reduction in body weight \\>5 kg within 3 months prior to screening\n4. Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n5. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to screening (e.g., mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal liner)\n6. Have obesity induced by other known endocrinologic disorders (e.g., Cushing syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., Melanocortin 4 Receptor deficiency or Prader Willi Syndrome) Note: If endocrinological disorder is suspected, a dexamethasone suppression test should be performed to assess for possible hypercortisolism\n\n   Other Medical\n7. Are currently breastfeeding\n8. Have structural cardiovascular disease (e.g., ischemic cardiovascular disease, heart failure, previous cerebrovascular accident \\[stroke\\])\n9. Have atrial fibrillation\n10. Have uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg)\n11. Have any visual, neurological, musculoskeletal, or other physical impairment that, in the opinion of the investigator, would prevent the participant from independently and appropriately self-administering the IMP and/or performing the resistance training program as required by the protocol (e.g., significant muscle or joint pain, significantly limited range of motion)\n12. Have renal impairment measured as estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2, calculated by Chronic Kidney Disease Epidemiology (CKD-EPI) 2021 creatinine-based equation during screening\n13. Have a known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility\n14. Have a history of chronic or acute pancreatitis Note: If acute pancreatitis is suspected, laboratory assessment of pancreatic amylase and/or lipase\n15. Have thyroid-stimulating hormone (TSH) outside the range of 0.4 to 6.0 mIU/L at the screening visit Note: Participants receiving treatment for hypothyroidism may be included, provided their thyroid hormone replacement dose has been stable for at least 3 months and their TSH at screening falls within the range indicated above.\n\n    Note: Participants with a history of subclinical hypothyroidism but a TSH at screening within the range indicated above may be included if, in the investigator's opinion, the participant is unlikely to require initiation of thyroid hormone replacement during the course of the study.\n16. Have a history of significant active or unstable major depressive disorder or other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) or other serious mood or anxiety disorder within the last 2 years Note: Participants with major depressive disorder or generalized anxiety disorder whose disease state is considered stable for the past 2 years and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications.\n17. Have a PHQ-9 score of 15 or more during screening\n18. Have acute suicidality, defined as endorsement of Item 4 and/or Item 5 of the Columbia-Suicide-Severity Scale (C-SSRS) at screening, or any condition that, in the judgment of the investigator, indicates a significant and immediate risk of suicide Note: The C-SSRS will only be assessed if PHQ-9 Item 9 is greater than 0\n19. Have a history of lifetime suicidal behavior, defined as any positive response within the \"Suicidal Behavior\" section of the C-SSRS (except non-suicidal self-injurious behavior) Note: The C-SSRS will only be assessed if PHQ-9 Item 9 is greater than 0\n20. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than metabolic dysfunction-associated fatty liver disease (MAFLD), or any of the following, as determined during screening:\n\n    * Alanine aminotransferase (ALAT) level \\>3.0x upper limit of normal (ULN) for the reference range\n    * Total bilirubin (TBL) level \\>1.5x ULN for the reference range (except for cases of known Gilbert's Syndrome) Note: If cholestatic liver disease is suspected, alkaline phosphatase level (ALP) must be \\<1.5x ULN for the reference range.\n\n    Note: Participants with MAFLD are eligible to participate in this trial if their ALAT level is ≤3.0x ULN for the reference range.\n21. Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2 or a serum calcitonin level during screening of:\n\n    * ≥20 ng/L, if eGFR ≥60 mL/min/1.73 m2, or\n    * ≥35 ng/L, if eGFR \\<60 mL/min/1.73 m2\n22. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years\n23. Have a history of any other condition, such as known drug, alcohol, or substance abuse (including regular use of marijuana or tetrahydrocannabinol-containing products), a diagnosed eating disorder, or other psychiatric disorder, that, in the opinion of the investigator, may interfere with the participant's ability to comply with and/or complete the protocol\n24. Have had a transplanted organ (other than corneal transplants \\[keratoplasty\\]) or awaiting an organ transplant\n25. Have any clinically significant hematological condition that may interfere with accurate HbA1c measurement or interpretation (e.g., hemolytic anemias or sickle cell disease)\n26. Have any other medical condition not listed above that, based on current clinical guidelines or in the opinion of the investigator, constitutes a contraindication to moderate-to-high intensity resistance training (e.g., active proliferative retinopathy, unstable musculoskeletal, neurological, or cardiovascular conditions, or other conditions associated with an increased risk of serious adverse events during resistance exercise)\n\n    Prior/concomitant therapy\n27. Have previously used a GLP-1 receptor agonist or a dual incretin receptor agonist at any time\n28. Are currently receiving, or have received within 3 months prior to screening, chronic systemic glucocorticoid therapy (\\>14 days), or have a clinically significant active autoimmune disease (e.g., lupus or rheumatoid arthritis) that, in the opinion of the investigator, requires or is likely to require systemic glucocorticoid treatment during the trial Note: Topical, intraocular, intranasal, intra-articular, or inhaled glucocorticoids are allowed\n29. Have current or history of (within 3 months prior to screening) treatment with medications that may cause significant weight gain, including but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.\n30. Have taken, within 3 months prior to screening, medications (other than GLP-1 or dual GIP/GLP-1 receptor agonists) or alternative remedies that promote weight loss Note: Use of metformin or any other glucose-lowering medication, whether prescribed for polycystic ovary syndrome or diabetes prevention, is not permitted.\n\n    Prior/concurrent clinical study / resistance training experience\n31. Are currently enrolled in any other clinical study involving an IMP or any other type of medical research judged not to be scientifically or medically compatible with this clinical trial\n32. Within the last 30 days of screening, have participated in a clinical trial and received treatment, whether active, or placebo. If the trial involved an IMP, 5 half-lives or 30 days, whichever is longer, should have passed.\n33. Have participated in structured resistance training program (≥ 2x/week for ≥ 4 consecutive weeks) within the last 3 months\n\n    Other exclusions\n34. Have any contraindication to MRI (e.g., non-MRI-compatible implanted devices, metallic foreign bodies, severe claustrophobia, or body size exceeding MRI scanner limitations \\[maximum bore diameter 70 cm\\])\n35. Have a planned absence of ≥14 consecutive days (or a total of ≥ 30 days) within the next 6 months that would prevent adherence to scheduled trial visits and/or the training intervention","locations":[{"facility":"Klinikum der Technischen Universität München (TUM Klinikum)","city":"München","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephan Mueller-Stegner, Dr rer nat","phone":"+49 (0)89 289-24494","email":"stephan.mueller@mri.tum.de"}],"primaryOutcomes":["Change in contractile thigh muscle volume (mL), as assessed by magnetic resonance imaging (MRI)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["m-nchen-germany"],"enrichment":{"headline":"Phase 4: testing Dual GIP/GLP-1 Receptor Agonist Tirzepatide for Obesity (BMI>30)","inPlainEnglish":"Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment. However, particularly fast weight loss may be accompanied by a significant loss of muscle mass, which is associated with a reduced metabolic rate at rest and during physical activity, increased insulin resistance, limited mobility, and potential long-term adverse effects.","whoItsFor":["Ages 18 Years to 60 Years","Are ≥ 18 years and ≤ 60 years of age","Have a body mass index (body-mass index (BMI)) of ≥ 30 kg/m2","Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight","In the investigator's opinion, are well motivated, capable, and willing to","learn how to self-inject the investigational medicinal product (IMP), as required for this protocol","inject the IMP, and","comply with trial procedures for the duration of the trial, including adherence to scheduled visits, the prescribed resistance training program (if assigned to the experimental group), lifestyle recommendations, and other requirements as specified in the protocol"],"whoShouldSkip":["Medical Conditions Diabetes Related","Have known Type 1 Diabetes, a history of Type 2 Diabetes (including those in remission), a history of ketoacidosis of any aetiology, or a history of hyperosmolar hyperglycaemic state or coma","Have at least one laboratory value suggestive of diabetes during screening including:","glycated hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol)","fasting glucose ≥126 mg/dL (≥7.0 mmol/L) Note: If a blood sample is collected under non-fasting conditions and the random glucose value is ≥200 mg/dL (≥11.1 mmol/L), an additional fasting blood sample will be obtained to confirm or exclude diabetes","Have a self-reported reduction in body weight \\>5 kg within 3 months prior to screening","Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)"],"whatHappens":"If you join, the listed intervention(s) are Dual GIP/GLP-1 Receptor Agonist Tirzepatide, or Resistance Training. The registry lists allocation as randomized. Incretin-based pharmacotherapies induce significant weight loss and represent a paradigm shift in obesity treatment.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 150 people at München. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.028Z"},{"nctId":"NCT07779460","title":"A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice","officialTitle":"Comparative Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice: A Retrospective Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC). This study will use two primary data sources that capture longitudinal, de-identified healthcare utilization derived from claims submitted for reimbursement.","conditions":["Multiple Sclerosis"],"keywords":["Multiple sclerosis","Ofatumumab","Ocrelizumab","Anti-CD20 therapy","Comparative effectiveness","Real-world evidence"],"interventions":[],"enrollment":7466,"startDate":"2026-04-08","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\nPatients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:\n\n* ≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period.\n* No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim.\n* ≥2 outpatient (OP) medical claims (at least 30 days apart) with a diagnosis code for MS (International Classification of Diseases, Tenth Revision, Clinical Modification \\[ICD-10-CM\\] code: G35) in any position, with the first claim occurring in the 12 months prior to or on index date and the second claim up to 6 months after index date, or ≥1 inpatient (IP) claim with MS recorded as the primary diagnosis in the 12 months prior to or on index date.\n* ≥18 years of age on index date.\n* Continuous healthcare plan enrollment for ≥12 months prior to index date and ≥6 months after index date.\n* Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date.\n\nPatients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria:\n\n* Included in pooled OMB cohort or pooled OCR cohort.\n* No claims for a disease-modifying therapy (DMT) used for the treatment of MS in the 12-month baseline period.\n\nExclusion criteria:\n\n• Patients who do not meet the study inclusion criteria.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Novartis","city":"East Hanover","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"","email":""}],"primaryOutcomes":["Annualized Relapse Rate (ARR) in Treatment-naïve MS Patients"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab","ofatumumab"],"locationSlugs":["east-hanover-new-jersey"],"enrichment":{"headline":"A Study Comparing Effectiveness of Kesimpta® (Ofatumumab) Versus Ocrevus® (Ocrelizumab) in Real-world Practice","inPlainEnglish":"This study aims to generate real-world evidence on the clinical effectiveness and economic burden of ofatumumab (OMB) versus ocrelizumab (OCR) in patients diagnosed with multiple sclerosis (MS) in the United States (US). Clinical effectiveness will be assessed using annualized relapse rate (ARR), while economic burden will be assessed using healthcare resource utilization (HCRU) and healthcare costs (HCC).","whoItsFor":["Ages 18 Years to 100 Years","Patients in the pooled OMB and pooled OCR cohorts are required to meet the following eligibility criteria:","≥1 incident claim for OMB (pooled OMB cohort) or OCR (pooled OCR cohort) in the patient identification period","No claims for OMB or OCR within the 12 months prior to the index date. The index date is the date of the first OMB or OCR claim","≥18 years of age on index date","Continuous healthcare plan enrollment for ≥12 months prior to index date and ≥6 months after index date","Persistent use of OMB (pooled OMB cohort) or OCR (pooled OCR cohort) for ≥6 months after index date","Patients in the treatment-naïve OMB and treatment-naïve OCR cohorts are required to meet the following eligibility criteria:"],"whoShouldSkip":["Patients who do not meet the study who can join","Other protocol-defined inclusion/"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 7,466 people at East Hanover. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.992Z"},{"nctId":"NCT07779616","title":"Study of PTC844 in Participants With Active Rheumatoid Arthritis","officialTitle":"A Phase 2A, Proof-of-Concept, Randomized, Parallel, Double-Blind, Placebo-Controlled Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of PTC844 in Participants With Active Rheumatoid Arthritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"PTC Therapeutics","sponsorClass":"INDUSTRY","summary":"This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to placebo in participants with active rheumatoid arthritis (RA).","conditions":["Rheumatoid Arthritis"],"keywords":["Immune-mediated disease","Autoimmune disease","Dihydroorotate dehydrogenase (DHODH) inhibitors","PTC844","Rheumatoid arthritis"],"interventions":[{"type":"DRUG","name":"PTC844"},{"type":"DRUG","name":"Placebo"}],"enrollment":75,"startDate":"2026-09-24","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria.\n* Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-CRP (score of ≥3.2) at screening.\n* Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and/or inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion.\n* Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study.\n* CRP of ≥5 milligrams (mg)/liter (L) at screening.\n\nKey Exclusion Criteria:\n\n* Presence of any clinically significant abnormality at screening, or prior or ongoing medical condition (for example, concomitant illness, psychiatric condition), surgical procedure, medical history, or physical findings that, in the investigator's opinion, could adversely affect the safety of the participant or could impair the assessment of study results.\n* Participants with Class IV RA.\n* Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis.\n* Past medical history of inflammatory joint disease other than RA or fibromyalgia.\n* Rheumatoid arthritis onset at \\<17 years of age.\n* Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection.\n* Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug.\n* Use or intended use of any prescribed disease-modifying treatments for RA within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit, except for methotrexate, low dose prednisone (\\<10 mg/day), hydroxychloroquine, or sulfasalazine, which are permitted as established background single-therapy medications.\n* Use or intended use of a combination of methotrexate, low dose prednisone (\\<10 mg/day), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit.\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"AARA Clinical Research - Arizona Arthritis and Rheumatology Associates - Chandler","city":"Chandler","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Flagstaff","city":"Flagstaff","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Millennium Clinical Trials","city":"Westlake Village","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nouvelle Clinical Research LLC","city":"Cutler Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vitaly Clinical Research, LLC","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Millennium Medical Research, LLC.","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research, Inc. - New Port Richey","city":"New Port Richey","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chicago Arthritis and Regenerative Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DJL Clinical Research PLLC","city":"Charlotte","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rheumatology Specialty Center","city":"Willow Grove","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Precision Comprehensive Clinical Research Solutions - Irving","city":"Irving","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis & Rheumatism Associates - Fairfax","city":"Fairfax","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aversi Clinic LLC","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"JSC Jerarsi","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"JSC Vian - Iv. Bokeria University Hospital","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"JSC VIAN Caraps Medline","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"LTD Caucasus Medical Centre","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"LTD Innova","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Medical Center LLC","city":"Tbilisi","state":"","country":"Georgia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CAP Research ltd","city":"Quatre Bornes","state":"","country":"Mauritius","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Clinical Research Trials CC","city":"Cape Town","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dr IC Louw","city":"Cape Town","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinresco Centres (Pty) Ltd","city":"Kempton Park","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials Network - Helderberg","city":"Somerset West","state":"","country":"South Africa","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patient Advocacy","phone":"1-866-562-4620","email":"medinfo@ptcbio.com"}],"primaryOutcomes":["Number of Participants With Treatment-emergent Adverse Events (TEAEs)","Change From Baseline to Week 2 in Dihydroorotate (DHO)"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["chandler-arizona","flagstaff-arizona","phoenix-arizona","westlake-village-california","cutler-bay-florida","miami-florida","new-port-richey-florida","winter-park-florida","chicago-illinois","charlotte-north-carolina","willow-grove-pennsylvania","irving-texas","fairfax-virginia","tbilisi-georgia","quatre-bornes-mauritius","cape-town-south-africa","kempton-park-south-africa","somerset-west-south-africa"],"enrichment":{"headline":"Phase 2: testing PTC844 for Rheumatoid Arthritis","inPlainEnglish":"This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to dummy treatment (placebo) in participants with active rheumatoid arthritis (RA).","whoItsFor":["Ages 18 Years to 70 Years","Historical diagnosis of RA as per the American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) diagnostic criteria","Active RA disease with a threshold of moderate activity or higher as confirmed via DAS28-a blood inflammation marker (CRP) (score of ≥3.2) at screening","Naïve to disease-modifying treatments for RA or have had an inadequate response to background treatment for RA and/or inability to tolerate disease-modifying antirheumatic drugs, as per investigator's discretion","Disease-modifying antirheumatic drugs should be stable and unchanged from 30 days prior to the start of the Screening Period and intend to remain stable and unchanged throughout the course of the study","a blood inflammation marker (CRP) of ≥5 milligrams (mg)/liter (L) at screening"],"whoShouldSkip":["Participants with Class IV RA","Past medical history of blood dyscrasia, bone marrow abnormality and/or suppression, drug induced thrombocytopenia or idiopathic thrombocytopenia, or bleeding diathesis","Past medical history of inflammatory joint disease other than RA or fibromyalgia","Rheumatoid arthritis onset at \\<17 years of age","Past medical history of malignancy within 5 years prior to screening, except for nonmelanoma skin cancers cursed via local resection","Participant has a known hypersensitivity to any of the ingredients of PTC844 or to any excipients of the study drug","Use or intended use of a combination of methotrexate, low dose prednisone (\\<10 mg/day), hydroxychloroquine, or sulfasalazine within 30 days or 5 half-lives (whichever is longer) before the Screening Period until completion of the Follow-Up Visit"],"whatHappens":"If you join, the listed intervention(s) are PTC844, or Placebo. The registry lists allocation as randomized. This study is designed to assess the safety, pharmacokinetics (PK), and biomarker effects of PTC844 compared to dummy treatment (placebo) in participants with active rheumatoid arthritis (RA).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 75 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.951Z"},{"nctId":"NCT07780188","title":"Lean Beef as Part of a Healthy Meal Plan in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)","officialTitle":"Effect of Increasing Lean Beef Intake as Part of a Healthy Meal Plan on Glycemic Control in Adolescents With Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Texas A&M University","sponsorClass":"OTHER","summary":"This pilot randomized controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to evaluate the effectiveness and feasibility of a tailored dietary intervention which will be termed \"Beef+\", that will emphasize the incorporation of unprocessed, lean beef (\\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life","conditions":["PCOS (Polycystic Ovary Syndrome)","Obese Adolescents","Overweight (Without Type 2 Diabetes) With Weight-related Comorbidities","Overweight Adolescents","Irregular Menstrual Cycle","Irregular Menstrual Cycles","Hirsutism","Hyperandrogenism"],"keywords":["Dietary Intervention","Polycystic Ovary Syndrome (PCOS)","Adolescents","Randomized Control Trial"],"interventions":[{"type":"OTHER","name":"Beef+"}],"enrollment":36,"startDate":"2026-09-01","completionDate":"2028-04-30","sex":"FEMALE","minAge":"11 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female Adolescent\n* 11-17 years old\n* Suspected or confirmed diagnosis of PCOS\n* ≥1-year post-menarche\n* BMI ≥85th percentile for age/height\n* Able to read and speak English\n\nExclusion Criteria:\n\n* Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)\n* Unable or unwilling to eat beef\n* Pregnant or planning pregnancy during study\n* HbA1c ≥6.5%\n* Unwilling or unable to complete study procedures\n* Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)\n* Conditions affecting reproductive function other than PCOS\n* Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies/reactions to medical adhesives\n\nConditional Exclusion Criteria:\n\n\\- Current use of hormonal contraceptives if in the suspected PCOS group (allowable if current for at least the previous 3 months with physician-confirmed PCOS)","locations":[{"facility":"Texas A&M AgriLife","city":"College Station","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Heidi K Vanden Brink, PhD, MSc, RDMS","phone":"979-321-7073","email":"heidi.vandenbrink@ag.tamu.edu"}],"primaryOutcomes":["Change in HbA1c"],"hasResults":false,"conditionSlugs":["type-2-diabetes","pcos"],"drugSlugs":[],"locationSlugs":["college-station-texas"],"enrichment":{"headline":"Not a traditional drug phase: Beef+ for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"This pilot randomly assigned controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to measure the effectiveness and feasibility of a tailored dietary intervention which will be termed \"Beef+\", that will emphasize the incorporation of unprocessed, lean beef (\\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life","whoItsFor":["Ages 11 Years to 17 Years","Women only","Suspected or confirmed diagnosis of PCOS","≥1-year post-menarche","body-mass index (BMI) ≥85th percentile for age/height"],"whoShouldSkip":["Medications affecting glucoregulation, metabolic health, and/or appetite (e.g., metformin, GLP-1)","Unable or unwilling to eat beef","Pregnant or planning pregnancy during study","Unwilling or unable to complete study procedures","Conditions affecting ability to complete study procedures or the intervention such as gastrointestinal diseases or syndromes, bleeding disorders, ongoing or unresolved eating disorder)","Conditions affecting reproductive function other than PCOS","Conditions that may interfere with continuous glucose monitor (CGM) application or use, including dermatological conditions such as eczema or allergies/reactions to medical adhesives"],"whatHappens":"If you join, the listed intervention(s) are Beef+. The registry lists allocation as randomized. This pilot randomly assigned controlled study will plan to enroll 36 adolescent females with Polycystic Ovary Syndrome (PCOS)/Polyendocrine Metabolic Ovarian Syndrome (PMOS) to measure the effectiveness and feasibility of a tailored dietary intervention which will be termed \"Beef+\", that will emphasize the incorporation of unprocessed, lean beef (\\<10% fat) as part of a healthy meal plan to improve glycemic control, diet quality, and health-related quality of life","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at College Station. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.792Z"},{"nctId":"NCT07780656","title":"A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-2)","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","conditions":["Pulmonary Disease, Chronic Obstructive"],"keywords":["Chronic obstructive pulmonary disease","GSK5784283","Eosinophilic phenotype","Felcorekibart","Monoclonal antibody","Thymic Stromal Lymphopoietin"],"interventions":[{"type":"DRUG","name":"GSK5784283"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care"}],"enrollment":624,"startDate":"2026-09-11","completionDate":"2029-07-20","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or eligible female participants.\n* Participants with \\>=40 to less than or equal to (\\<=) 80 years of age.\n* An eosinophilic phenotype with elevated BEC.\n* Moderate to very severe COPD with frequent exacerbations.\n* Participants with elevated COPD assessment test (CAT) score.\n* Current or former cigarette smokers.\n* On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate.\n\nExclusion Criteria:\n\n* Current or prior physician diagnosis of asthma.\n* Other clinically significant lung disease.\n* Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.\n* Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.\n* Continuous oxygen therapy (more than 16 hours/ day).\n* Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.\n* A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.","locations":[{"facility":"GSK Investigational Site","city":"Cape Coral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Greenacres City","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Rapid City","state":"South Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"West Point","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Annualized rate of moderate or severe COPD Exacerbations"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["cape-coral-florida","greenacres-city-florida","miami-florida","tampa-florida","new-york-new-york","rapid-city-south-dakota","west-point-utah","spokane-washington"],"enrichment":{"headline":"Phase 3: testing GSK5784283 for Pulmonary Disease, Chronic Obstructive","inPlainEnglish":"The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to dummy treatment (placebo) in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","whoItsFor":["Ages 40 Years to 80 Years","Male or eligible female participants","Participants with \\>=40 to less than or equal to (\\<=) 80 years of age","An eosinophilic phenotype with elevated BEC","Moderate to very severe COPD with frequent exacerbations","Participants with elevated COPD assessment test (CAT) score","Current or former cigarette smokers","On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate"],"whoShouldSkip":["Current or prior physician diagnosis of asthma","Other clinically significant lung disease","Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1","Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure","Continuous oxygen therapy (more than 16 hours/ day)","Cor pulmonale resulting in right heart failure and severe pulmonary hypertension","A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix)"],"whatHappens":"If you join, the listed intervention(s) are GSK5784283, Placebo, or Standard of care. The registry lists allocation as randomized. The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to dummy treatment (placebo) in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 624 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.657Z"},{"nctId":"NCT07780669","title":"A Study to Investigate the Efficacy and Safety of GSK5784283 (Felcorekibart) Compared With Placebo in Participants With Moderate to Very Severe COPD (PERSIST COPD-1)","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study of the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants 40 to 80 Years of Age With Moderate to Very Severe COPD (PERSIST COPD-1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to placebo in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","conditions":["Pulmonary Disease, Chronic Obstructive"],"keywords":["Chronic obstructive pulmonary disease","GSK5784283","Eosinophilic phenotype","Felcorekibart","Monoclonal antibody","Thymic Stromal Lymphopoietin"],"interventions":[{"type":"DRUG","name":"GSK5784283"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care"}],"enrollment":624,"startDate":"2026-08-27","completionDate":"2029-07-20","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or eligible female participants\n* Participants with \\>=40 to less than or equal to (\\<=) 80 years of age.\n* An eosinophilic phenotype with elevated BEC.\n* Moderate to very severe COPD with frequent exacerbations.\n* Participants with elevated COPD assessment test (CAT) score.\n* Current or former cigarette smokers.\n* On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate.\n\nExclusion Criteria:\n\n* Current or prior physician diagnosis of asthma\n* Other clinically significant lung disease.\n* Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1.\n* Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure.\n* Continuous oxygen therapy (more than 16 hours/ day).\n* Cor pulmonale resulting in right heart failure and severe pulmonary hypertension.\n* A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.","locations":[{"facility":"GSK Investigational Site","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Humble","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Huntsville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"West Jordan","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Fukuoka","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tokyo","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Annualized rate of moderate or severe COPD Exacerbations"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["doral-florida","lake-charles-louisiana","humble-texas","huntsville-texas","west-jordan-utah","fukuoka-japan","tokyo-japan"],"enrichment":{"headline":"Phase 3: testing GSK5784283 for Pulmonary Disease, Chronic Obstructive","inPlainEnglish":"The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to dummy treatment (placebo) in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","whoItsFor":["Ages 40 Years to 80 Years","Male or eligible female participants","Participants with \\>=40 to less than or equal to (\\<=) 80 years of age","An eosinophilic phenotype with elevated BEC","Moderate to very severe COPD with frequent exacerbations","Participants with elevated COPD assessment test (CAT) score","Current or former cigarette smokers","On triple (Inhaled corticosteroid \\[ICS\\]+ Long-acting muscarinic antagonist \\[LAMA\\]+ Long-acting beta-agonist \\[LABA\\]) or dual inhaled COPD therapy, if ICS is considered not appropriate"],"whoShouldSkip":["Current or prior physician diagnosis of asthma","Other clinically significant lung disease","Pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1","Participants with a history of, or plan for lung volume reduction surgery / endobronchial valve procedure","Continuous oxygen therapy (more than 16 hours/ day)","Cor pulmonale resulting in right heart failure and severe pulmonary hypertension","A current malignancy or history of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix)"],"whatHappens":"If you join, the listed intervention(s) are GSK5784283, Placebo, or Standard of care. The registry lists allocation as randomized. The study primarily aims to demonstrate the superiority of GSK5784283 as an add-on therapy compared to dummy treatment (placebo) in reducing the annualized rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 624 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.655Z"},{"nctId":"NCT07781501","title":"Long-Term Study of COVID-19 Infection and Long COVID","officialTitle":"Longitudinal Study of Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and Post-Acute Sequelae of COVID-19 (PASC)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of North Carolina, Chapel Hill","sponsorClass":"OTHER","summary":"This study will examine how common Long COVID is and how symptoms may persist over time in people who have previously had COVID-19. Researchers will collect information about participants' health and symptoms through questionnaires and may collect saliva and other non-invasive oral samples. The study will also examine biological factors in these samples that may be associated with persistent symptoms. The goal is to better understand why some people develop Long COVID and identify factors that may help predict who is more likely to experience persistent symptoms.","conditions":["SARS CoV-2 Post-Acute Sequelae"],"keywords":["COVID-19","SARS-CoV-2","Long COVID"],"interventions":[{"type":"OTHER","name":"This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms."}],"enrollment":500,"startDate":"2024-09-04","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 75 years.\n* Previous laboratory-confirmed SARS-CoV-2 infection.\n* Willing and able to provide informed consent.\n* Able to complete study questionnaires and study procedures.\n\nExclusion Criteria:\n\n* Current severe periodontal disease with bleeding gums.\n* Current oral herpes flare, aphthous ulcer, or oral candidiasis (thrush).\n* Oral viral or bacterial infection within the previous 30 days.\n* Dry mouth that would prevent adequate saliva collection.\n* Active alcohol or drug abuse.\n* Medical or genetic syndrome or developmental delay that would prevent completion of study procedures or questionnaires.","locations":[{"facility":"University of North Carolina","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Laura A Jacox, PhD, DMD, MS","phone":"+1 847-702-0988","email":"ljacox@live.unc.edu"},{"name":"Jeannene L Matthews, MA, M.Ed., CCC-SLP","phone":"+1 919-907-9685","email":"jlab@unc.edu"}],"primaryOutcomes":["Salivary Proteomic Profile","Salivary Metabolomic Profile","Validated Health Questionnaires: SBQ-LC (Symptom Burden Questionnaire - Long COVID)","Validated Health Questionnaire: C19-YRS (COVID-19 Yorkshire Rehabilitation Scale)","Validated Health Questionnaire: EFTER-COVID survey"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: This study is observational. Only patients who have previously tested positive for SARS-CoV-2 infection or are experiencing ongoing symptoms. for SARS CoV-2 Post-Acute Sequelae","inPlainEnglish":"This study will examine how common Long COVID is and how symptoms may persist over time in people who have previously had COVID-19. Researchers will collect information about participants' health and symptoms through questionnaires and may collect saliva and other non-invasive oral samples.","whoItsFor":["Ages 18 Years to 75 Years","Age 18 to 75 years","Previous laboratory-confirmed SARS-CoV-2 infection","Able to complete study questionnaires and study procedures"],"whoShouldSkip":["Current severe periodontal disease with bleeding gums","Current oral herpes flare, aphthous ulcer, or oral candidiasis (thrush)","Oral viral or bacterial infection within the previous 30 days","Dry mouth that would prevent adequate saliva collection","Active alcohol or drug abuse","Medical or genetic syndrome or developmental delay that would prevent completion of study procedures or questionnaires"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Chapel Hill. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.238Z"},{"nctId":"NCT07781644","title":"Study to Test Effects and Safety of RO7568282 in Early Parkinson's Disease","officialTitle":"A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early-stage Parkinson's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of RO7568282 compared with placebo in participants with early-stage Parkinson's disease (PD) on stable symptomatic monotherapy with levodopa.","conditions":["Parkinson's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7568282"},{"type":"DRUG","name":"Placebo"}],"enrollment":474,"startDate":"2026-11-10","completionDate":"2028-12-15","sex":"ALL","minAge":"40 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be aged 40 to 85 years inclusive\n* Diagnosis of idiopathic PD\n* Has received stable doses of monotherapy treatment with levodopa for at least 2 months prior to baseline\n* Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline\n* Hoehn and Yahr (H\\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline\n* Able to swallow whole capsules\n\nExclusion Criteria:\n\n* Medical history indicating a parkinsonian syndrome other than idiopathic PD\n* Diagnosis of PD dementia\n* Diagnosis of a significant neurologic disease other than PD\n* Within the last year, unstable or clinically significant cardiovascular disease\n* Chronic uncontrolled hypertension\n* History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD\n\nNote: Other protocol-defined inclusion/exclusion criteria also apply","locations":[{"facility":"Parkinson's Disease and Movement Disorders Center of Boca Raton","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ninewells Hospital, Dundee- Scotland","city":"Dundee","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal London Hospital","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: BP46441 https://forpatients.roche.com/ No email attachments.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Time to a Confirmed Motor Progression Event From the Randomization Date, as Measured by the MDS-UPDRS Part III Score"],"hasResults":false,"conditionSlugs":["parkinson"],"drugSlugs":[],"locationSlugs":["boca-raton-florida","shanghai-china","dundee-united-kingdom","london-united-kingdom"],"enrichment":{"headline":"Phase 2: testing RO7568282 for Parkinson's Disease","inPlainEnglish":"This study wants to measure the how well it works, safety, and pharmacokinetics (PK) of RO7568282 compared with dummy treatment (placebo) in participants with early-stage Parkinson's disease (PD) on stable symptomatic this drug alone with levodopa.","whoItsFor":["Ages 40 Years to 85 Years","Must be aged 40 to 85 years inclusive","Diagnosis of idiopathic PD","Has received stable doses of this drug alone treatment with levodopa for at least 2 months prior to baseline","Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV score of 0 at screening and prior to randomization at baseline","Hoehn and Yahr (H\\&Y) Stage ≤ 3 (assessed in off medication state) at screening and prior to randomization at baseline","Able to swallow whole capsules"],"whoShouldSkip":["Medical history indicating a parkinsonian syndrome other than idiopathic PD","Diagnosis of PD dementia","Diagnosis of a significant neurologic disease other than PD","Within the last year, unstable or clinically significant cardiovascular disease","Chronic uncontrolled hypertension","History or presence of brain magnetic resonance imaging (MRI) scan showing evidence of structural abnormalities, other than related to PD","Note: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are RO7568282, or Placebo. The registry lists allocation as randomized. This study wants to measure the how well it works, safety, and pharmacokinetics (PK) of RO7568282 compared with dummy treatment (placebo) in participants with early-stage Parkinson's disease (PD) on stable symptomatic this drug alone with levodopa.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 474 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.665Z"},{"nctId":"NCT07781657","title":"Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease","officialTitle":"A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).","conditions":["Alzheimer's Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7568282"},{"type":"DRUG","name":"Placebo"}],"enrollment":450,"startDate":"2026-11-15","completionDate":"2029-11-01","sex":"ALL","minAge":"50 Years","maxAge":"90 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF)\n* Mild cognitive impairment (MCI) or mild dementia due to AD\n* Able to swallow whole capsules\n* Body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening)\n* Availability of an appropriate study partner\n\nExclusion Criteria:\n\n* Any evidence of a condition other than AD that may affect cognition\n* Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities\n* History or presence of clinically significant cerebrovascular disease\n* Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI)\n\nNote: Other protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Alzheimer's Research and Treatment Center","city":"Stuart","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alzheimer?s Research and Treatment Center","city":"Wellington","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research, LLC","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Basil Clinical","city":"Laurelton","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Prince Alfred Hospital","city":"Camperdown","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Royal Melbourne Hospital","city":"Parkville","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Groupement Hospitalier Est - Hôpital Neurologique","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["stuart-florida","wellington-florida","winter-park-florida","laurelton-new-york","camperdown-australia","parkville-australia","bron-france"],"enrichment":{"headline":"Phase 2: testing RO7568282 for Alzheimer's Disease","inPlainEnglish":"This study aims to compare the effects of RO7568282 versus a dummy treatment (placebo) in people in the early stages of Alzheimer's disease (AD).","whoItsFor":["Ages 50 Years to 90 Years","Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF)","Mild cognitive impairment (MCI) or mild dementia due to AD","Able to swallow whole capsules","Body mass index (body-mass index (BMI)) within the range of 18-34 kilograms per square metre (kg/m²) (at screening)","Availability of an appropriate study partner"],"whoShouldSkip":["Any evidence of a condition other than AD that may affect cognition","Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities","History or presence of clinically significant cerebrovascular disease","Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI)","Note: Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are RO7568282, or Placebo. The registry lists allocation as randomized. This study aims to compare the effects of RO7568282 versus a dummy treatment (placebo) in people in the early stages of Alzheimer's disease (AD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 450 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.326Z"},{"nctId":"NCT07781709","title":"Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Substudy","officialTitle":"Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass-Penn Pilot Low Load Resistance Exercise Training Substudy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy. The substudy will implement a low-load resistance exercise training for the lower extremities, focusing primarily on the gastrocnemius muscles. The goal of this intervention is to understand how low-load resistance training will impact blood flow and oxygen tissue extraction on the lower legs.","conditions":["Pulmonary Arterial Hypertension"],"keywords":["PAH","Exercise"],"interventions":[{"type":"DEVICE","name":"Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12."},{"type":"DIAGNOSTIC_TEST","name":"Blood draw"}],"enrollment":20,"startDate":"2026-11-02","completionDate":"2029-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria: Participating the main MUSCLE UP Study:\n\n* Signed informed consent prior to initiation of any study mandated procedure.\n* Male and female patient's ≥ 18 years of age.\n* Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \\[Humbert 2022\\]\n* Idiopathic (IPAH)\n* Heritable (HPAH)\n* Drugs or toxins induced\n* Associated (APAH) with one of the following:\n* Connective tissue disease;\n* Human immunodeficiency virus (HIV) infection;\n* Congenital heart disease; or\n* Portopulmonary hypertension\n* Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment\n* Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:\n* mPAP \\> 20 mmHg; and\n* PAWP or LVEDP ≤ 15 mmHg\n* PVR \\> 2 Wood units\n\nExclusion Criteria:\n\n* Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:\n* FEV1/FVC ≤ 5th percentile; and\n* FEV1 z-score \\< -2.5\n* Prior to enrollment, evidence of severe restrictive defect with\n* TLC \\< 5th percentile\n* FEV1 z-score \\< -4\n* More than moderate aortic or mitral valve disease\n* LVEF \\< 40% within 1 year of screening\n* Pregnancy","locations":[{"facility":"University of Pennsylvania Hospital","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rebecca Gallagher Research Project Manager, MSEd","phone":"215-662-4088","email":"rebecca.lang@pennmedicine.upenn.edu"},{"name":"Nicole Denney, MS","phone":"215-615-4156","email":"nicole.denney@pennmedicine.upenn.edu"}],"primaryOutcomes":["Difference in circulating level of adiponectin (ng/mL) pre- and post-exercise at baseline and at Week 12"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12. for Pulmonary Arterial Hypertension","inPlainEnglish":"After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy. The substudy will implement a low-load resistance exercise training for the lower extremities, focusing primarily on the gastrocnemius muscles.","whoItsFor":["Ages 18 Years to any","Participating the main MUSCLE UP Study:","Male and female patient's ≥ 18 years of age","Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification \\[Humbert 2022\\]","Drugs or toxins induced","Associated (APAH) with one of the following:","Connective tissue disease;","Human immunodeficiency virus (HIV) infection;"],"whoShouldSkip":["Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:","FEV1/FVC ≤ 5th percentile; and","FEV1 z-score \\< -2.5","Prior to enrollment, evidence of severe restrictive defect with","TLC \\< 5th percentile","More than moderate aortic or mitral valve disease","LVEF \\< 40% within 1 year of screening"],"whatHappens":"If you join, the listed intervention(s) are Measurement of oxyhemoglobin and deoxyhemoglobin concentration pre and post- exercise at baseline and Week 12. Measurement of time to recovery of oxyhemglobin post-exercise at baseline and at Week 12., or Blood draw. The registry lists allocation as na. After completion of the Baseline study visit for the main study (MUSCLE UP-PH), participants at the University of Pennsylvania location will be invited to participate in an optional substudy.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Philadelphia. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.034Z"},{"nctId":"NCT07782333","title":"A Study Evaluating TRIV-573 in Atopic Dermatitis","officialTitle":"A Phase 2, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Multiple Subcutaneous Doses of TRIV-573 in Participants With Moderate to Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Triveni Bio","sponsorClass":"INDUSTRY","summary":"The goal of this interventional study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also evaluate the safety of TRIV-573.\n\nParticipants will receive 5 doses of the study intervention that they are randomized to (TRIV-573 or placebo).\n\nThe study duration for individual participants is up to 40 weeks, including a Screening period of up to 30 days.","conditions":["Atopic Dermatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"TRIV-573"},{"type":"DRUG","name":"Placebo"}],"enrollment":90,"startDate":"2026-09-09","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Has Atopic Dermatitis.\n* Has moderate to severe, active and symptomatic atopic dermatitis.\n\nExclusion Criteria:\n\n* Severe or uncontrolled medical conditions.\n* Use of prohibited medications within stated washout periods.","locations":[{"facility":"Triveni Bio Site #15","city":"Fountain Valley","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #4","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #11","city":"Boca Raton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #7","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #3","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #2","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #13","city":"Bay City","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #16","city":"Boardman","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #1","city":"Camp Hill","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #14","city":"Myrtle Beach","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #9","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #6","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #8","city":"Spokane","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #17","city":"Calgary","state":"Alberta","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #5","city":"Barrie","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #12","city":"Ivano-Frankivsk","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Triveni Bio Site #10","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Triveni Bio, Inc","phone":"+1 (781) 472-2230","email":"clinicaltrials@triveni.bio"}],"primaryOutcomes":["Percentage of participants with improvement of AD"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["fountain-valley-california","los-angeles-california","boca-raton-florida","miami-florida","indianapolis-indiana","bay-city-michigan","boardman-ohio","camp-hill-pennsylvania","myrtle-beach-south-carolina","san-antonio-texas","spokane-washington","calgary-canada","barrie-canada","ivano-frankivsk-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 2: testing TRIV-573 for Atopic Dermatitis","inPlainEnglish":"The goal of this treatment study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults. It will also measure the safety of TRIV-573.","whoItsFor":["Ages 18 Years to 75 Years","Has Atopic Dermatitis","Has moderate to severe, active and symptomatic atopic dermatitis"],"whoShouldSkip":["Severe or uncontrolled medical conditions","Use of prohibited medications within stated washout periods"],"whatHappens":"If you join, the listed intervention(s) are TRIV-573, or Placebo. The registry lists allocation as randomized. The goal of this treatment study is to learn if TRIV-573 works to treat moderate to severe atopic dermatitis in adults.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at 17 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.830Z"},{"nctId":"NCT07782359","title":"Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib","officialTitle":"Impact of Tirzepatide on Lorlatinib-Associated Weight Gain and Metabolic Derangements in Patients With Non-Small Cell Lung Cancer (NSCLC)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Chicago","sponsorClass":"OTHER","summary":"The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated efficacy in weight reduction and metabolic improvement. This study seeks to evaluate its potential to mitigate side effects while preserving the therapeutic efficacy of lorlatinib.","conditions":["Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":30,"startDate":"2026-10-22","completionDate":"2030-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Receiving lorlatinib as first-line treatment for advanced NSCLC ALK-positive, already prescribed and administered by the patient's treating oncologist as standard of care at the time of study enrollment. This study does not initiate lorlatinib therapy or assign lorlatinib dosing; participants must already be receiving lorlatinib prior to enrollment\n\nExclusion Criteria:\n\n* Known hypersensitivity to GLP-1 agonists.\n* Active, unstable psychiatric illness; current suicidal ideation\n* Severe organ dysfunction or systemic illness.\n* Anorexia nervosa\n* History of pancreatitis\n* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2\n* Current use of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) or glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) \\[GLP-1 RA/GIP\\] co-agonist use within the last 90 days prior to screening\n* Current anti-obesity medication use (other than GLP-1 RA) or dipeptidyl peptidase-4 (DPP4) inhibitor use or use within the last 30 days prior to screening\n* Pregnant, breastfeeding or planning pregnancy","locations":[{"facility":"University of Chicago Medicine Comprehensive Cancer Center","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Intake Intake","phone":"855-702-8222","email":"cancerclinicaltrials@bsd.uchicago.edu"}],"primaryOutcomes":["Body weight changes","Lipid changes","Change in Cmax","Change in Tmax","Bioavailability"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["tirzepatide"],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Phase 1: testing Tirzepatide for Lung Cancer","inPlainEnglish":"The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes. In this study patients with non-small cell lung cancer (NSCLC) receiving lorlatinib treatment will receive tirzepatide, a dual GIP/GLP-1 receptor agonist with demonstrated how well it works in weight reduction and metabolic improvement.","whoItsFor":["Ages 18 Years to any"],"whoShouldSkip":["Known hypersensitivity to GLP-1 agonists","Active, unstable psychiatric illness; current suicidal ideation","Severe organ dysfunction or systemic illness","History of pancreatitis","Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2","Current use of Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RA) or glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) \\[GLP-1 RA/GIP\\] co-agonist use within the last 90 days prior to screening","Current anti-obesity medication use (other than GLP-1 RA) or dipeptidyl peptidase-4 (DPP4) inhibitor use or use within the last 30 days prior to screening"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient outcomes.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Chicago. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.022Z"},{"nctId":"NCT07782996","title":"A Study to Investigate the Efficacy and Safety of GSK5784283 Compared With Placebo in Participants With Uncontrolled Asthma (PERSIST ASTHMA-2)","officialTitle":"A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of GSK5784283 (Felcorekibart) as an Add-On Therapy in Adults and Adolescents With Uncontrolled Asthma (PERSIST ASTHMA-2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"GlaxoSmithKline","sponsorClass":"INDUSTRY","summary":"The study aims to demonstrate the superiority of GSK5784283 compared to placebo in reducing the annualized rate of clinically meaningful asthma exacerbations.","conditions":["Asthma"],"keywords":["Asthma","Felcorekibart","GSK5784283","Placebo","Standard of care"],"interventions":[{"type":"DRUG","name":"GSK5784283"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Standard of care"}],"enrollment":370,"startDate":"2026-08-27","completionDate":"2029-05-04","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in Informed consent form (ICF), For participants aged 12 to 17 years, signed assent must be obtained from the participant in addition to signed consent from their Legally acceptable representative (LAR).\n* Participants aged 12 to 80 years at the time of signing the informed consent.\n* Male or eligible female participants:\n\n  * Female participants:\n\n    * A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:\n\n      i. Is a Participant of non-childbearing potential (PONCBP) or ii. Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (\\<) 1 percent (%), 28 days prior to the first dose of the study drug, and during the study intervention period and follow-up period for at least 60 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., non-compliance, recently initiated) in relationship to the first dose of study intervention.\n* A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention.\n* If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.\n* Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials.\n* A documented physician diagnosis of asthma for at least 12 months prior to Visit 1, according to the Global Initiative for Asthma (GINA) 2026 guidelines.\n* Evidence of variable airflow obstruction consistent with asthma.\n* Documented history of asthma exacerbation within 12 months prior to Visit 1.\n* A well-documented requirement for regular treatment with medium or high dose Inhaled corticosteroid (ICS) for at least 3 months prior to screening with or without maintenance oral corticosteroids (OCS).\n* At least 1 additional maintenance asthma controller medication is required according to standard practice of care (e.g., Long-acting beta-2 agonist \\[LABA\\], Leukotriene receptor antagonists \\[LTRA\\], theophylline, Long-acting muscarinic agonists \\[LAMA\\], chromones, etc.). Use of additional asthma controller medications must be documented for at least 3 months prior to screening.\n* Uncontrolled asthma based on ACQ-5 score.\n\nExclusion Criteria:\n\n* Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results.\n* History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix).\n* Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia.\n* New York Heart Association (NYHA) class III or IV heart failure.\n* Other significant medical conditions that could impact participants' safety or study outcomes.\n* History of an unresolved clinically significant infection within 30 days prior to Visit 1.\n* A known immunodeficiency other than that explained by the use of corticosteroids taken as therapy for asthma.\n* Receipt of any marketed or investigational biologic agent or investigational non-biologic agent, prior to Visit 1.\n* Use of systemic immunosuppressive medication within 3 months prior to Visit 1 (other than systemic corticosteroid burst or stable maintenance OCS for treatment of asthma).\n* Current smokers (tobacco and/or marijuana), current users of vaping products/electronic-cigarettes or participants with a smoking history \\>=10 pack-years.","locations":[{"facility":"GSK Investigational Site","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"DuBois","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"GSK Investigational Site","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US GSK Clinical Trials Call Center","phone":"877-379-3718","email":"GSKClinicalSupportHD@gsk.com"},{"name":"EU GSK Clinical Trials Call Center","phone":"+44 (0) 20 89904466","email":"GSKClinicalSupportHD@gsk.com"}],"primaryOutcomes":["Annualized rate of clinically significant asthma exacerbations"],"hasResults":false,"conditionSlugs":["asthma"],"drugSlugs":[],"locationSlugs":["san-diego-california","miami-florida","miami-lakes-florida","tampa-florida","dubois-pennsylvania","houston-texas"],"enrichment":{"headline":"Phase 3: testing GSK5784283 for Asthma","inPlainEnglish":"The study aims to demonstrate the superiority of GSK5784283 compared to dummy treatment (placebo) in reducing the annualized rate of clinically meaningful asthma exacerbations.","whoItsFor":["Ages 12 Years to 80 Years","Male or eligible female participants:","Female participants:","A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:","A POCBP must have a negative serum pregnancy test at screening and a highly sensitive pregnancy test (urine or serum, as required by local regulations) within 24 hours before each dose of study intervention","If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive","The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy","Contraceptive use by women should be consistent with local regulations regarding the methods of highly effective contraception for those participating in clinical trials"],"whoShouldSkip":["Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the investigational product or interpretation of participant safety or study results","History of malignant neoplasm within the last 5 years (except definitively treated non-melanoma skin cancer or carcinoma in situ of the uterine cervix)","Myocardial infarction, unstable angina or stroke within 6 months of screening, unstable arrhythmia","New York Heart Association (NYHA) class III or IV heart failure","Other significant medical conditions that could impact participants' safety or study outcomes","History of an unresolved clinically significant infection within 30 days prior to Visit 1","A known immunodeficiency other than that explained by the use of corticosteroids taken as therapy for asthma"],"whatHappens":"If you join, the listed intervention(s) are GSK5784283, Placebo, or Standard of care. The registry lists allocation as randomized. The study aims to demonstrate the superiority of GSK5784283 compared to dummy treatment (placebo) in reducing the annualized rate of clinically meaningful asthma exacerbations.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 370 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.345Z"},{"nctId":"NCT07783074","title":"Fatigue Investigation Using Digital Outcomes","officialTitle":"Fatigue Investigation Using Digital Outcomes (FIDO) - An Exploratory Project","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Liliana Barrios","sponsorClass":"OTHER","summary":"This study investigates objective methods to measure and monitor fatigue in patients with post-COVID-19 condition (long COVID) and multiple sclerosis (MS), and includes a group of healthy volunteers for comparison. Fatigue is a common and debilitating symptom of both conditions, but current assessment methods rely mainly on questionnaires, which can be limited by subjectivity and recall bias. The study uses a smartphone application (the FIDO app) together with wearable devices to continuously collect data on fatigue and its fluctuations during daily life, in order to evaluate the potential of digital, objective measures compared to standard assessments.\n\nParticipation lasts approximately eight weeks and includes two in-person clinic visits along with a continuous data collection phase. At the initial visit, participants complete baseline assessments and questionnaires and are introduced to the study's digital tools. During the following weeks, participants wear two wearable devices continuously (24 hours a day) and use the FIDO app to complete short daily tasks (approximately 7 minutes every two days) and brief questionnaires (approximately 5 minutes per day). All participants collect a stool sample at home at weeks 4 and 8 for gut microbiome analysis, and complete the Fatigue Scale for Motor and Cognitive Functions at week 4. At the final study visit, participants repeat a subset of the baseline assessments, provide feedback on the digital technology used, and return the study devices.","conditions":["Multiple Sclerosis","Long Covid","Healthy"],"keywords":["digital biomarker","wearable devices","passive sensing","smartphone application","remote monitoring","actigraphy","heart rate variability","long COVID","Post-Acute COVID-19 Syndrome","feasibility study","compliance","adherence","fatigue monitoring","gut microbiome","post-exertional malaise","PEM","MS","FSMC","fatigue","fatigability","motor fatigue","cognitive fatigue","physical fatigue","smartwatch","ActiGraph LEAP","Apple Watch","Garmin","smartphone"],"interventions":[],"enrollment":122,"startDate":"2026-05-26","completionDate":"2028-05-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria Multiple Sclerosis or Long COVID\n\n* Confirmed diagnosis of MS (by neurologist) or Long COVID (by medical doctor).\n* Smartphone ownership.\n* Provide written informed consent.\n* Fluent in German or English.\n\nInclusion Criteria Healthy:\n\n* Smartphone ownership.\n* Provide written informed consent.\n* Fluent in German or English.\n\nExclusion Criteria:\n\n* Concomitant medication affecting fatigue or ANS such as antidepressants prescribed or adjusted 1 month before the initial visit.\n* Unable to provide informed consent.\n* Unwilling or unable to comply with the study protocol.\n* Pregnancy or lactation.\n* For controls: Diagnosis of any chronic disorders or diseases that may affect fatigue or ANS.\n* For MS: Additional comorbidities that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease.\n* For long COVID: Additional comorbidities diagnosed prior to the first acute COVID-19 infection that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease.","locations":[{"facility":"Neurozentrum Basel Messeturm","city":"Basel","state":"Basel","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellevue Medical Group - Neurozentrum Sternen / Neurozentrum Bellevue","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Zurich","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"NeuroPraxis Zürich GmbH","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bellevue Medical Group - Neurozentrum Seefeld","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Klinik Lengg AG","city":"Zurich","state":"Canton of Zurich","country":"Switzerland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liliana Barrios, Dr. sc. ETH Zürich","phone":"+41774141174","email":"fido@dsi.uzh.ch"}],"primaryOutcomes":["Percentage of Expected Smartwatch Wear Time Recorded Over Two Months","Percentage of Expected Armband Activity Monitor Wear Time Recorded Over Two Months","Percentage of Scheduled Study Application Questionnaires Completed Over Two Months","Percentage of Scheduled Study Application Performance Tasks Completed Over Two Months"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","long-covid"],"drugSlugs":[],"locationSlugs":["basel-switzerland","zurich-switzerland"],"enrichment":{"headline":"Fatigue Investigation Using Digital Outcomes","inPlainEnglish":"This study investigates objective methods to measure and monitor fatigue in patients with post-COVID-19 condition (long COVID) and multiple sclerosis (MS), and includes a group of healthy volunteers for comparison. Fatigue is a common and debilitating symptom of both conditions, but current assessment methods rely mainly on questionnaires, which can be limited by subjectivity and recall bias.","whoItsFor":["Ages 18 Years to 65 Years","Multiple Sclerosis or Long COVID","Confirmed diagnosis of MS (by neurologist) or Long COVID (by medical doctor)","Smartphone ownership","Fluent in German or English","who can join Healthy:"],"whoShouldSkip":["Concomitant medication affecting fatigue or ANS such as antidepressants prescribed or adjusted 1 month before the initial visit","Unwilling or unable to comply with the study protocol","Pregnancy or lactation","For controls: Diagnosis of any chronic disorders or diseases that may affect fatigue or ANS","For MS: Additional comorbidities that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease","For long COVID: Additional comorbidities diagnosed prior to the first acute COVID-19 infection that may affect fatigue or ANS such as autoimmune disease and cardiovascular disease"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 122 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.243Z"},{"nctId":"NCT07783425","title":"A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema","officialTitle":"A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, ACTIVE- AND PLACEBO-CONTROLLED PHASE 3 MONOTHERAPY STUDY WITH MAINTENANCE PERIOD TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS 12 YEARS OF AGE AND OLDER WITH MODERATE-TO-SEVERE ATOPIC DERMATITIS","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin.\n\nThe study is seeking participants who:\n\n* Are aged 12 years or older.\n* Were confirmed to have atopic dermatitis (AD) at least 12 months ago.\n* Are not having an effective treatment result from medicines that are applied on skin for AD.\n* Are considered by their doctors to have moderate to severe AD.\n\nThe study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48.\n\nSome participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.","conditions":["Atopic Dermatitis"],"keywords":["Immune system diseases","skin diseases, genetic","eczema","atopic dermatitis","Dermatitis","skin diseases","Skin Diseases, Eczematous"],"interventions":[{"type":"DRUG","name":"Tilrekimig"},{"type":"DRUG","name":"Dupilumab"},{"type":"OTHER","name":"Placebo for Tilrekimig"},{"type":"OTHER","name":"Placebo for Dupilumab"}],"enrollment":1375,"startDate":"2026-08-24","completionDate":"2028-09-08","sex":"ALL","minAge":"12 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n* You are \\[12\\] years of age or older\n* You have had moderate-to-severe eczema for at least 1 year\n* Topical medicines for eczema have not worked well for you\n\nKey Exclusion Criteria\n\n* Clinically Significant Autoimmune Disease\n* Significant Infection History or Active Infection\n* Known or Suspected Immunodeficiency/Immunosuppression\n* Significant psychiatric illness or suicidality\n* Clinically significant hepatic, renal, or hematologic abnormalities","locations":[{"facility":"AllerVie Clinical Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cahaba Dermatology & Skin Health Center","city":"Birmingham","state":"Alabama","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Alliance Dermatology & MOHS Center","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Trial Associates, Inc.","city":"Bryant","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kern Research, Inc.","city":"Bakersfield","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"First OC Dermatology Research Inc","city":"Fountain Valley","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Marvel Clinical Research","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Avance Clinical Trials","city":"Laguna Niguel","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"California Allergy & Asthma Medical Group","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Northridge Clinical Trials, LLC","city":"Northridge","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wolverine Clinical Trials","city":"Santa Ana","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Direct Helpers Research Center","city":"Hialeah","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Associates of South Florida, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Global Health Research Center, Inc.","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Clinical Research Institute","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Skin Care Physicians of Georgia","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Marietta Dermatology Clinical Research, Inc.","city":"Marietta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Treasure Valley Medical Research","city":"Boise","state":"Idaho","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dawes Fretzin Clinical Research Group, LLC","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maryland Laser Skin and Vein","city":"Hunt Valley","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Troy","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Respiratory Medicine Research Institute of Michigan, PLC","city":"Ypsilanti","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Empire Dermatology","city":"East Syracuse","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vital Prospects Clinical Research Institute., PC","city":"Tulsa","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Medical Research Center","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Best Skin Research, LLC","city":"Camp Hill","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions, LLC.","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arlington Research Center","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dermatology Treatment and Research Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Derm Texas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Stryde Research-Epiphany Dermatology","city":"Southlake","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Complete Dermatology","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alexandria Associates in Dermatology","city":"Arlington","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Innovaderm Research Inc","city":"Montreal","state":"Quebec","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Japan Community Healthcare Organization Chukyo Hospital","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Iwate Medical University Hospital","city":"Yahaba-cho","state":"Iwate","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Queen's Square Medical Facilities Queen's Square Medical Center, Dermatology and Allergology","city":"Yokohama","state":"Kanagawa","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Osaka Habikino Medical Center","city":"Habikino","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Izumigaoka Skin Clinic","city":"Sakai","state":"Osaka","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dermatology and Ophthalmology Kume Clinic","city":"Sakai","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dokkyo Medical University Hospital","city":"Shimotsuga-gun","state":"Tochigi","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nihonbashi Sakura Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fukuwa Clinic","city":"Chuo-ku","state":"Tokyo","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tachikawa Dermatology Clinic","city":"Tachikawa","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ikebukuro-nishiguchi Fukurou Dermatology Clinic","city":"Toshima-ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Katahira Dermatology Urology Clinic","city":"Kagoshima","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital","city":"Okayama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pansy Skin Clinic","city":"Saitama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"China Medical University Hospital","city":"Taichung","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Difference in the proportion of Eczema Area and Severity Index (EASI)75 responders between tilrekimig versus placebo.","Difference in the proportion of validated Investigator Global Assessment- Atopic Dermatitis (vIGA-AD) 0/1 responders between tilrekimig versus placebo."],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["birmingham-alabama","phoenix-arizona","bryant-arkansas","bakersfield-california","fountain-valley-california","huntington-beach-california","laguna-niguel-california","los-angeles-california","northridge-california","santa-ana-california","hialeah-florida","miami-florida","miami-lakes-florida","orlando-florida","tampa-florida","macon-georgia","marietta-georgia","boise-idaho","indianapolis-indiana","hunt-valley-maryland","troy-michigan","ypsilanti-michigan","east-syracuse-new-york","tulsa-oklahoma","portland-oregon","camp-hill-pennsylvania","memphis-tennessee","arlington-texas","dallas-texas","southlake-texas","sugar-land-texas","arlington-virginia","montreal-canada","nagoya-japan","yahaba-cho-japan","yokohama-japan","habikino-japan","sakai-japan","shimotsuga-gun-japan","chuo-ku-japan","tachikawa-japan","toshima-ku-japan","kagoshima-japan","okayama-japan","saitama-japan","taichung-taiwan"],"enrichment":{"headline":"Phase 3: testing Tilrekimig for Atopic Dermatitis","inPlainEnglish":"This study wants to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin.","whoItsFor":["Ages 12 Years to any","You are \\[12\\] years of age or older","You have had moderate-to-severe eczema for at least 1 year","Topical medicines for eczema have not worked well for you"],"whoShouldSkip":["Clinically Significant Autoimmune Disease","Significant Infection History or Active Infection","Known or Suspected Immunodeficiency/Immunosuppression","Significant psychiatric illness or suicidality","Clinically significant hepatic, renal, or hematologic abnormalities"],"whatHappens":"If you join, the listed intervention(s) are Tilrekimig, Dupilumab, or Placebo for Tilrekimig. The registry lists allocation as randomized. This study wants to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,375 people at 50 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.819Z"},{"nctId":"NCT07783581","title":"Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial","officialTitle":"Phase II: Randomized Neoadjuvant Treatment of Oral Cavity Cancer With Spatially Fractionated Proton Radiotherapy and Immunotherapy (OSPRI)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"This phase II trial compares the effect of adding proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT) to standard immunotherapy pembrolizumab before surgery (neoadjuvant) in treating patients with oral cavity squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back where it first started (primary site) or near it (locoregionally recurrent) and have not had (naive) prior radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Proton SFRT is a type of external beam radiation treatment that uses streams of protons (tiny particles with a positive charge) to deliver different doses of radiation to different parts of the tumor in a grid like pattern. This type of radiation kills tumor cells but does not damage nearby tissues. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant proton SFRT or SBRT in combination with pembrolizumab may be safe and tolerable and may be an effective approach to shrink the tumor, reduce the extent of surgery and/or the need for further treatment in patients with locally advanced or locoregionally recurrent oral cavity squamous cell cancer.","conditions":["Locally Advanced Oral Cavity Squamous Cell Carcinoma","Locally Recurrent Oral Cavity Squamous Cell Carcinoma","Oral Cavity Squamous Cell Carcinoma"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Biopsy Procedure"},{"type":"PROCEDURE","name":"Biospecimen Collection"},{"type":"PROCEDURE","name":"Computed Tomography"},{"type":"PROCEDURE","name":"Magnetic Resonance Imaging"},{"type":"BIOLOGICAL","name":"Pembrolizumab"},{"type":"RADIATION","name":"Photon Stereotactic Body Radiation Therapy"},{"type":"PROCEDURE","name":"Positron Emission Tomography"},{"type":"RADIATION","name":"Spatially-fractionated Radiation Therapy"},{"type":"PROCEDURE","name":"Surgical Procedure"}],"enrollment":30,"startDate":"2026-11-04","completionDate":"2030-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with histologically confirmed human papillomavirus (HPV)/p16-unrelated squamous cell carcinoma of the oral cavity and:\n\n  * Either locally advanced (T3-T4) non-metastatic disease, or\n  * Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted)\n* Age ≥ 18 years old\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2\n* Eligible to receive immunotherapy on multidisciplinary evaluation\n* Ability to complete questionnaire(s) by themselves or with assistance\n* Provide signed written informed consent in accordance with ethical, regulatory, and institutional requirements\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Willing to consent to and provide tissue and blood samples for correlative research purposes (not the optional Riskguard and OncoExtra testing)\n* PD-L1 combined positive score ≥ 1\n\nExclusion Criteria:\n\n* Participation in another clinical study with an investigational product during the last 3 months (12 weeks)\n\n  * Exception: Unless it is an observational (non-interventional) clinical study during the follow-up period of the study\n* Contraindications to pembrolizumab\n* Prior radiation therapy to the head and neck\n* Previous anticancer therapeutic received ≤ 30 days prior to registration, or adequate washout period on a per-agent basis, or concurrent anti-cancer therapeutic not specified by this protocol\n* Uncontrolled pre-existing condition(s), such as infection, congestive heart failure, hypertension, angina, arrhythmia, chronic diarrhea, psychiatric conditions, or others, that in the opinion of the treating investigator limits the ability to provide consent or longitudinal participation in this study\n* Inability to place 2 or more SFRT spheres within the tumor target\n* Prophylactic placement of feeding tubes is not allowed","locations":[{"facility":"Mayo Clinic in Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Referral Office","phone":"855-776-0015","email":"mayocliniccancerstudies@mayo.edu"}],"primaryOutcomes":["Improvement in major pathologic response rate (MPR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["pembrolizumab"],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Phase 2: testing Pembrolizumab for Locally Advanced Oral Cavity Squamous Cell Carcinoma","inPlainEnglish":"This phase II trial compares the effect of adding proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT) to standard immunotherapy pembrolizumab before surgery (neoadjuvant) in treating patients with oral cavity squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back where it first started (primary site) or near it (locoregionally recurrent) and have not had (who have not tried this kind of treatment before) prior radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors.","whoItsFor":["Ages 18 Years to any","Patients with histologically confirmed human papillomavirus (HPV)/p16-unrelated squamous cell carcinoma of the oral cavity and:","Either locally advanced (T3-T4) non-metastatic disease, or","Radiation-naïve locoregionally recurrent disease (prior radiation to a site outside of the treatment fields is permitted)","Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2","Eligible to receive immunotherapy on multidisciplinary evaluation","Ability to complete questionnaire(s) by themselves or with assistance","Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)"],"whoShouldSkip":["Participation in another clinical study with an investigational product during the last 3 months (12 weeks)","Exception: Unless it is an watch-and-measure (no experimental treatment required) (non-treatment) clinical study during the follow-up period of the study","Contraindications to pembrolizumab","Prior radiation therapy to the head and neck","Previous anticancer therapeutic received ≤ 30 days prior to registration, or adequate washout period on a per-agent basis, or concurrent anti-cancer therapeutic not specified by this protocol","Inability to place 2 or more SFRT spheres within the tumor target","Prophylactic placement of feeding tubes is not allowed"],"whatHappens":"If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase II trial compares the effect of adding proton spatially fractionated radiotherapy (SFRT) or photon stereotactic body radiotherapy (SBRT) to standard immunotherapy pembrolizumab before surgery (neoadjuvant) in treating patients with oral cavity squamous cell cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has come back where it first started (primary site) or near it (locoregionally recurrent) and have not had (who have not tried this kind of treatment before) prior radiation.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Rochester. Taking part typically means an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.342Z"},{"nctId":"NCT07783802","title":"A Study of Clazakizumab (LY5724886) in Adults With Elevated hsCRP and at Increased Risk for Cardiovascular Event","officialTitle":"A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Clazakizumab in Reducing hsCRP in Adults With Elevated hsCRP and Established ASCVD or at Increased Risk for ASCVD Events","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with placebo in adults who have elevated hsCRP and at increased risk for cardiovascular event.\n\nParticipation in the study will last about 9 months.","conditions":["Atherosclerosis","Cardiovascular Disease","Obesity","Hypertension","Diabetes Mellitus, Type 2","Renal Insufficiency, Chronic"],"keywords":["Interleukin-6 (IL-6)","IL-6 inhibition","C-reactive protein","Residual inflammatory risk","Cardiovascular risk","Monoclonal antibody"],"interventions":[{"type":"DRUG","name":"Clazakizumab"},{"type":"DRUG","name":"Placebo"}],"enrollment":120,"startDate":"2026-08-27","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* hsCRP ≥2 mg/L and ≤15 mg/L at screening\n* At least one of the following chronic conditions:\n\n  * Established atherosclerotic cardiovascular disease (ASCVD)\n  * Obesity (body mass index (BMI) ≥30 kg/m2)\n  * Type 2 diabetes\n  * Hypertension\n  * Chronic kidney disease Grade 3 or 4\n\nExclusion Criteria:\n\n* Acute cardiovascular event within 60 days prior to screening\n* Acute decompensated heart failure hospitalization within 60 days prior to screening\n* Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization\n* New York Heart Association Class III or IV heart failure\n* Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg)\n* Type 1 diabetes\n* Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol/mol) at screening\n* Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \\<15 mL/min/1.73 m², or history of kidney transplant\n* Dialysis or acute kidney injury within 60 days prior to screening\n* Congenital/hereditary kidney disease, polycystic kidney disease, lupus nephritis, or antineutrophil cytoplasmic antibody-associated vasculitis\n* Active tuberculosis, untreated latent tuberculosis, or known hepatitis B or hepatitis C infection\n* Serious, opportunistic, chronic, or recurrent infection requiring treatment within 12 weeks prior to screening\n* Significant active autoimmune disease\n* Suspected or confirmed immunocompromised state (e.g., HIV infection)\n* History of peptic ulcer disease or gastrointestinal ulceration within 12 months prior to screening\n* History of symptomatic diverticular disease (diverticulitis), gastrointestinal perforation, or major gastrointestinal surgery\n* Mechanical heart valve prosthesis requiring chronic vitamin K antagonist anticoagulation\n* Use of colchicine within 14 days prior to screening or anticipated need during the study\n* Use of immunosuppressive or immunomodulatory agents, including other biologic anti-IL-6 therapies, within specified windows prior to screening\n* Use of systemic corticosteroids within 14 days prior to screening\n* Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs)","locations":[{"facility":"Heart Center Research, LLC","city":"Huntsville","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pima Heart","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eclipse Clinical Research","city":"Tucson","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thrive Clinical Research Group","city":"Glendora","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omega Research Orlando","city":"Altamonte Springs","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"American Research Institute","city":"Cutler Bay","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Maitland","city":"Maitland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Institute For Clinical Research, LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - DuPage","city":"Lombard","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Franciscan Physician Network - Indiana Heart Physicians","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Foxborough","city":"Foxborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"Dearborn","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Olive Branch Family Medical Center","city":"Olive Branch","state":"Mississippi","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Excel Clinical Research, LLC","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Palm Research Center Tenaya","city":"Las Vegas","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research - Buffalo","city":"Buffalo","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHEAR Center LLC","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Cincinnati, Springdale","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suburban Research Associates","city":"West Chester","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiology Consultants of Philadelphia Yardley","city":"Yardley","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research - Charleston","city":"North Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Horizon Clinical Research Group","city":"Cypress","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cardiovascular Specialists of Willowbrook","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Cardiology Associates of Houston","city":"Kingwood","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revival Research Institute, LLC","city":"McKinney","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Institute of Cardiology, PA","city":"McKinney","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ogden Clinic - Canyon View","city":"Ogden","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carient Heart & Vascular - Manassas","city":"Manassas","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Carient Heart and Vascular LLC-Reston","city":"Reston","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CIPREC","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cicemo Srl","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CARDIAMET Investigaciones Médicas","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mautalen Salud e Investigación","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CEMEDIC","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fundación Respirar","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Médico Catamarca IMEC","city":"Rosario","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigaciones Clinicas del Litoral","city":"Santa Fe","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Salud e Investigaciones Médicas","city":"Santa Rosa","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Minamino Cardiovascular Hospital","city":"Hachiōji","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Takai Internal Medicine Clinic","city":"Kamakura-shi","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nakakinen clinic","city":"Naka","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"International University of Health and Welfare Narita Hospital","city":"Narita","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dorado Medical Complex","city":"Dorado","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wellness clinical Research Vega Baja","city":"Vega Baja","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percent Change from Baseline in hsCRP"],"hasResults":false,"conditionSlugs":["obesity","hypertension"],"drugSlugs":[],"locationSlugs":["huntsville-alabama","tucson-arizona","glendora-california","altamonte-springs-florida","cutler-bay-florida","maitland-florida","orlando-florida","woodstock-georgia","lombard-illinois","indianapolis-indiana","foxborough-massachusetts","dearborn-michigan","olive-branch-mississippi","las-vegas-nevada","buffalo-new-york","the-bronx-new-york","cincinnati-ohio","west-chester-pennsylvania","yardley-pennsylvania","north-charleston-south-carolina","cypress-texas","houston-texas","kingwood-texas","mckinney-texas","ogden-utah","manassas-virginia","reston-virginia","buenos-aires-argentina","rosario-argentina","santa-fe-argentina","santa-rosa-argentina","hachi-ji-japan","kamakura-shi-japan","naka-japan","narita-japan","dorado-puerto-rico","vega-baja-puerto-rico"],"enrichment":{"headline":"Phase 2: testing Clazakizumab for Atherosclerosis","inPlainEnglish":"This study wants to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with dummy treatment (placebo) in adults who have elevated hsCRP and at increased risk for cardiovascular event. Participation in the study will last about 9 months.","whoItsFor":["Ages 18 Years to any","hsCRP ≥2 mg/L and ≤15 mg/L at screening","At least one of the following chronic conditions:","Established atherosclerotic cardiovascular disease (ASCVD)","Obesity (body mass index (body-mass index (BMI)) ≥30 kg/m2)","Chronic kidney disease Grade 3 or 4"],"whoShouldSkip":["Acute cardiovascular event within 60 days prior to screening","Acute decompensated heart failure hospitalization within 60 days prior to screening","Planned coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or major surgery at the time of randomization","New York Heart Association Class III or IV heart failure","Uncontrolled hypertension at screening (systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg)","Type 2 diabetes with Hemoglobin A1c ≥9.0% (86 mmol/mol) at screening","Nephrotic syndrome, estimated glomerular filtration rate (eGFR) \\<15 mL/min/1.73 m², or history of kidney transplant"],"whatHappens":"If you join, the listed intervention(s) are Clazakizumab, or Placebo. The registry lists allocation as randomized. This study wants to measure the change in high-sensitivity C-reactive protein (hsCRP), a marker of inflammation in the body, with clazakizumab compared with dummy treatment (placebo) in adults who have elevated hsCRP and at increased risk for cardiovascular event.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 120 people at 46 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.508Z"},{"nctId":"NCT07786454","title":"A Trial of the Safety and Tolerability of SEP-363856 in Adults With Generalized Anxiety Disorder","officialTitle":"A Phase 3, Multicenter, Open-Label Extension Trial to Evaluate the Safety and Tolerability of SEP-363856 in the Treatment of Adults With Generalized Anxiety Disorder","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Otsuka Pharmaceutical Development & Commercialization, Inc.","sponsorClass":"INDUSTRY","summary":"This is a global, Phase 3, multicenter, open-label extension trial designed to evaluate the long-term safety, tolerability and efficacy of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.","conditions":["Generalized Anxiety Disorder"],"keywords":["Generalized Anxiety Disorder","GAD","Anxiety"],"interventions":[{"type":"DRUG","name":"SEP-363856"}],"enrollment":1120,"startDate":"2026-10-08","completionDate":"2029-05-26","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria\n\n1. Male or female participants at least 18 years of age at the time of informed consent\n2. Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention\n3. Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856\n4. Participant is willing and able to comply with study procedures and visit schedule\n5. i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions\n\nKey Exclusion Criteria\n\n1. Diagnosis other than GAD that is the primary focus of treatment\n2. Clinically significant psychiatric or medical condition that may interfere with study participation\n3. Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and efficacy outcomes\n4. Clinically significant abnormal laboratory values or ECG findings\n5. Significant suicide risk\n6. Substance use/positive drug screen\n7. Use of prohibited medications/therapies\n8. Known sensitivity to SEP-363856","locations":[{"facility":"Clinical Neuroscience Solutions, LLC","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Basil Clinical","city":"Jamaica","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Otsuka Call Center","phone":"844-687-8522","email":"ProfessionalServices@otsuka-us.com"}],"primaryOutcomes":["Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and TEAEs Leading to Discontinuation"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["jacksonville-florida","jamaica-new-york"],"enrichment":{"headline":"Phase 3: testing SEP-363856 for Generalized Anxiety Disorder","inPlainEnglish":"This is a global, Phase 3, multicenter, open-label extension trial designed to measure the long-term safety, tolerability and how well it works of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.","whoItsFor":["Ages 18 Years to any","Completed one of the prior GAD Phase 3 studies involving SEP-363856 through Week 8 without discontinuation of trial intervention","Able to continue treatment without interruption, and is considered by investigator to potentially benefit from SEP-363856","Participant is willing and able to comply with study procedures and visit schedule","i) Females of childbearing potential: negative pregnancy test and agreement to use acceptable contraception ii) Males: agreement to follow protocol-defined contraception and reproductive restrictions"],"whoShouldSkip":["Diagnosis other than GAD that is the primary focus of treatment","Clinically significant psychiatric or medical condition that may interfere with study participation","Lifetime history of meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for, or was diagnosed during the prior study with, a psychiatric disorder that would compromise accurate assessment of safety and how well it works outcomes","Clinically significant abnormal laboratory values or ECG findings","Significant suicide risk","Substance use/positive drug screen","Use of prohibited medications/therapies"],"whatHappens":"If you join, the listed intervention(s) are SEP-363856. The registry lists allocation as na. This is a global, Phase 3, multicenter, open-label extension trial designed to measure the long-term safety, tolerability and how well it works of SEP-363856 administered at doses of 50 milligrams (mg) or 75 mg per day in adult participants with generalized anxiety disorder (GAD) over a treatment period of 26 weeks.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,120 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.352Z"},{"nctId":"NCT07786870","title":"Expression of TSLP Isoforms in Asthma","officialTitle":"TSLP and Its Isoforms (Short and Long Form TSLP) in Different Asthma Phenotypes","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Medical University of Warsaw","sponsorClass":"OTHER","summary":"Asthma is a heterogeneous disease characterized by chronic airway inflammation, leading to variable airflow obstruction, bronchial hyperresponsiveness, excessive mucus secretion, and, consequently, structural airway remodeling. Asthma is defined by the presence of symptoms such as wheezing, dyspnea, chest tightness, and cough, with variable intensity and frequency.\n\nThymic stromal lymphopoietin (TSLP) is a cytokine produced primarily by epithelial cells in the lungs. Two distinct isoforms of TSLP have been identified: a long form (lfTSLP) and a short form (sfTSLP). The long isoform is induced during inflammatory conditions and promotes a T2-dependent immune response. In contrast, the short isoform is believed to exert homeostatic and anti-inflammatory functions and exhibits antimicrobial properties.\n\nStudies have demonstrated an association between elevated serum and airway TSLP levels and increased disease severity, as well as reduced spirometric parameters. However, the literature contains limited data regarding the expression of TSLP isoforms across different asthma phenotypes and their relationship with the degree of disease control.\n\nThe goal of this study is:\n\n1. To assess the expression of TSLP protein and TSLP mRNA, including its isoforms (sfTSLP and lfTSLP), in serum and in airway-derived samples (nasal epithelial cells),\n2. To compare these levels among patients with different asthma phenotypes (allergic and non-allergic asthma; eosinophilic, neutrophilic, and paucigranulocytic asthma; early-onset and late-onset asthma; obesity-associated asthma; cough-variant asthma), as well as between patients with asthma and healthy controls.\n3. To analyze the correlations between the expression of TSLP isoforms (sfTSLP and lfTSLP) and asthma severity, level of disease control (as measured by the Asthma Control Questionnaire \\[ACQ\\]), pulmonary function parameters, blood eosinophil count and other clinical parameters.","conditions":["Asthma Atopic","Asthma Severe Persistent Uncontrolled"],"keywords":["TSLP","asthma","airway epithelium"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"No Intervention: Observational Cohort"}],"enrollment":70,"startDate":"2024-04-30","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"1. Inclusion criteria\n\n   * age \\> 18 years, without the upper age limit,\n   * asthma (diagnosis in accordance with the GINA 2023 guidelines),\n2. Exclusion criteria\n\n   * other respiratory diseases (e.g., chronic obstructive pulmonary disease \\[COPD\\]);\n   * active cigarette smoking or a smoking history of \\>10 pack-years;\n   * active malignancy;\n   * active pulmonary tuberculosis or active respiratory tract infection;\n   * use of antibiotics within 4 weeks prior to study enrollment;\n   * current long-term home oxygen therapy (\\>15 hours per day);\n   * current treatment with monoclonal antibody therapies (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, or other biologics);\n   * pregnancy.","locations":[{"facility":"Department of Internal Medicine, Pulmonary Diseases and Allergy, Medical University of Warsaw, Warsaw, Poland,","city":"Warsaw","state":"Warsaw","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Izabela Orzołek, MD","phone":"+48516223281","email":"izabela.orzolek@wum.edu.pl"}],"primaryOutcomes":["TSLP mRNA expression, including the sfTSLP and lfTSLP isoforms in nasal epithelial cells and TSLP protein expression in blood and nasal epithelial cells"],"hasResults":false,"conditionSlugs":["obesity","asthma"],"drugSlugs":[],"locationSlugs":["warsaw-poland"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention: Observational Cohort for Asthma Atopic","inPlainEnglish":"Asthma is a heterogeneous disease characterized by chronic airway inflammation, leading to variable airflow obstruction, bronchial hyperresponsiveness, excessive mucus secretion, and, consequently, structural airway remodeling. Asthma is defined by the presence of symptoms such as wheezing, dyspnea, chest tightness, and cough, with variable intensity and frequency.","whoItsFor":["Ages 18 Years to any","age \\> 18 years, without the upper age limit,","asthma (diagnosis in accordance with the GINA 2023 guidelines),"],"whoShouldSkip":["other respiratory diseases (e.g., chronic obstructive pulmonary disease \\[COPD\\]);","active cigarette smoking or a smoking history of \\>10 pack-years;","active pulmonary tuberculosis or active respiratory tract infection;","use of antibiotics within 4 weeks prior to study enrollment;","current long-term home oxygen therapy (\\>15 hours per day);","current treatment with monoclonal antibody therapies (e.g., omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, or other biologics);"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 70 people at Warsaw. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.711Z"},{"nctId":"NCT07787169","title":"A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease","officialTitle":"A Master Protocol for Phase 1 Clinical Trials of Multiple Amyloid-Targeting Therapies for the Treatment of Alzheimer's Disease","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this Master Protocol is to support multiple studies looking at safety and tolerability of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease. Participants will enroll into either A1D-MC-AT01 (NCT07787182) or A1D-MC-AT02 (upcoming).","conditions":["Alzheimer Disease","Amyloid","Plaque, Amyloid","Healthy Volunteers"],"keywords":[],"interventions":[{"type":"DRUG","name":"LY4405094"},{"type":"DRUG","name":"LY4405094"},{"type":"DRUG","name":"Placebo"},{"type":"DRUG","name":"Placebo"},{"type":"OTHER","name":"Florbetapir F18"},{"type":"OTHER","name":"Florbetaben F 18"}],"enrollment":179,"startDate":"2026-09-09","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll.\n\nInclusion Criteria for Healthy Participants:\n\n* Are between 18 and 45 years of age\n* Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²)\n* Are overtly healthy as determined by medical evaluation, including medical history, physical examination, and electrocardiograms (ECGs).\n\nInclusion Criteria for Participants with Alzheimer's Disease (AD):\n\n* Are between 55-85 years of age\n* Have gradual and progressive changes in memory function, as reported by the participant or their study partner, for greater than or equal to (≥) 6 months at screening, as well as a clinical diagnosis of mild cognitive impairment due to AD or mild-to-moderate AD dementia as determined by the investigator or based on medical history.\n* Have Mini-Mental State Exam (MMSE) score ≥16\n* Have positive amyloid positron emission tomography (PET)\n* Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant. A second person may serve as backup.\n* For participants on symptomatic treatments for AD (for example, cholinesterase inhibitors, memantine) the dosing regimen must be stable, in the opinion of the investigator, for at least 8 weeks before randomization to a study intervention, and the dosing regimen is planned to remain stable.\n\nExclusion Criteria for all Participants:\n\n* Have currently, or a history of, serious or unstable neurological or psychological disease (except for AD for participants in the AD cohorts).\n* Have currently, or a history of, significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological diseases.\n* Have currently, or a history of, allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone.\n* Have currently, or a history of, clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions.\n* Have currently, or a history of cancer within the past 5 years except for some early skin cancers that have been resected with no evidence of metastatic disease for 3 years.\n* Have received any amyloid-targeting therapy (ATT), whether marketed or investigational; or have received active immunization against amyloid beta (Aβ).\n* Have received an active study intervention, within the last 30 days, in a clinical study involving an IMP.\n* Are pregnant or breastfeeding or intend to become pregnant or to breastfeed during the study;\n* Have an abnormal blood pressure, pulse rate, or both, as determined by the investigator, or a preexisting history of hypertension.\n\nExclusion Criteria for Healthy Participants:\n\n* Have a locally read brain magnetic resonance imaging (MRI) that demonstrates any clinically significant findings, including but not limited to, findings suggestive of CAA, that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.\n* Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), or have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP.\n* Have a family history of early onset AD (AD diagnosed before 65 years of age).\n\nExclusion Criteria for Participants with AD:\n\n* Contraindications or unable to tolerate MRI\n* Have a centrally read brain MRI that demonstrates the presence of Amyloid-Related Imaging Abnormalities with Edema/Effusion (ARIA-E), greater than (\\>)4 cerebral microhemorrhages, any evidence of superficial siderosis, any macrohemorrhage, or severe white matter disease; \\>2 lacunar infarcts or any territorial infarct \\>1 square centimeters (cm²); significant abnormalities that suggest another potential etiology for progressive dementia, or clinically significant finding that, in the opinion of the investigator, may impact the participant's ability to safely participate in the study.\n* Contraindications to amyloid PET scan.","locations":[{"facility":"CenExel ACT","city":"Anaheim","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Irvine Clinical Research","city":"Irvine","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Collaborative Neuroscience Network - CNS","city":"Los Alamitos","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fortrea Clinical Research Unit","city":"Daytona Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - The Villages","city":"Lady Lake","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research","city":"Maitland","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Charter Research","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Progressive Medical Research","city":"Port Orange","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Alzheimer's Research and Treatment Center","city":"Stuart","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research - Tampa","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Charter Research","city":"The Villages","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accel Research Sites - NeuroStudies Clinical Research Unit","city":"Decatur","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"QUEST Research Institute","city":"Farmington Hills","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xuanwu Hospital Capital Medical University","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Minhang District","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Tokyo Hospital","city":"Bunkyō City","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Center for Geriatrics and Gerontology","city":"Ōbu","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["The number of participants allocated to each substudy"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["anaheim-california","irvine-california","los-alamitos-california","daytona-beach-florida","lady-lake-florida","maitland-florida","orlando-florida","port-orange-florida","stuart-florida","tampa-florida","the-villages-florida","decatur-georgia","farmington-hills-michigan","beijing-china","minhang-district-china","shanghai-china","bunky-city-japan","bu-japan"],"enrichment":{"headline":"Phase 1: testing LY4405094 for Alzheimer Disease","inPlainEnglish":"The purpose of this Master Protocol is to support multiple studies looking at whether it is safe and how hard side effects are to live with of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease. Participants will enroll into either A1D-MC-AT01 (NCT07787182) or A1D-MC-AT02 (upcoming).","whoItsFor":["Ages 18 Years to 85 Years","Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll","for Healthy Participants:","Are between 18 and 45 years of age","Have a body mass index (body-mass index (BMI)) of 18.0 to 32.0 kilograms per square meter (kg/m²)","Are overtly healthy as determined by medical evaluation, including medical history, physical examination, and electrocardiograms (ECGs)","who can join for Participants with Alzheimer's Disease (AD):","Are between 55-85 years of age"],"whoShouldSkip":["for all Participants:","Have currently, or a history of, serious or unstable neurological or psychological disease (except for AD for participants in the AD cohorts)","Have currently, or a history of, significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological diseases","Have currently, or a history of, allergies to monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisolone","Have currently, or a history of, clinically significant multiple or severe drug allergies or severe posttreatment hypersensitivity reactions","Have currently, or a history of cancer within the past 5 years except for some early skin cancers that have been resected with no evidence of metastatic disease for 3 years","Have received any amyloid-targeting therapy (ATT), whether marketed or investigational; or have received active immunization against amyloid beta (Aβ)"],"whatHappens":"If you join, the listed intervention(s) are LY4405094, LY4405094, or Placebo. The registry lists allocation as randomized. The purpose of this Master Protocol is to support multiple studies looking at whether it is safe and how hard side effects are to live with of different drugs in healthy participants and participants with Alzheimer's disease, and if they remove clumps of protein (amyloid plaque) in the brain in participants with Alzheimer's Disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 179 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.331Z"},{"nctId":"NCT07788807","title":"A Study to Investigate How Well an Intracolonic Formulation of Two Monoclonal Antibodies is Tolerated in Healthy Participants and the Ability for the Antibodies to be Taken up by the Body Via the Colon","officialTitle":"An Open-label, Phase 1, Pharmacokinetic Study of a Single Dose of Transcolonically Administered Adalimumab and Guselkumab in Healthy Adult Participants","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Surmount Services, Inc.","sponsorClass":"INDUSTRY","summary":"This is a proof-of-concept study to investigate whether antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation. The study endpoints chosen for this study are commonly used for evaluating the safety, tolerability, and PK of single doses of IPs. No interim analysis is planned.","conditions":["Healthy Subjects"],"keywords":[],"interventions":[{"type":"DRUG","name":"Adalimumab"},{"type":"DRUG","name":"Guselkumab"},{"type":"DRUG","name":"SDL-001"}],"enrollment":18,"startDate":"2026-10-07","completionDate":"2026-11-20","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of the study drug, at the discretion of the PI or designee.\n* Body mass index (BMI) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 and ≤ 100 kg.\n\nExclusion Criteria:\n\n* Pregnant, planning to become pregnant, or currently breastfeeding\n* Current or recent clinically significant infection\n* Any history of inflammatory bowel disease\n* History of malignancy, except for non-melanoma skin cancer excised","locations":[{"facility":"University of the Sunshine Coast Clinical Trials, Maroochydore","city":"Maroochydore","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christopher Moller","phone":"+61 7 5409 8659","email":"cmoller@usc.edu.au"}],"primaryOutcomes":["Plasma PK parameters Cmax","Plasma PK parameters- Tmax","Plasma PK parameters- AUC0-last","Serum concentration of adalimumab","Serum concentration of guselkumab"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["adalimumab"],"locationSlugs":["maroochydore-australia"],"enrichment":{"headline":"Phase 1: testing Adalimumab for Healthy Subjects","inPlainEnglish":"This is a proof-of-concept study to see if antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation. The study endpoints chosen for this study are commonly used for evaluating the safety, tolerability, and PK of single doses of IPs.","whoItsFor":["Ages 18 Years to 45 Years","In good general health, with no significant medical history, and have no clinically significant abnormalities on physical examination at Screening and/or before the first administration of the study drug, at the discretion of the PI or designee","Body mass index (body-mass index (BMI)) between ≥ 18.0 and ≤ 32.0 kg/m2 and weight ≥ 50 and ≤ 100 kg"],"whoShouldSkip":["Pregnant, planning to become pregnant, or currently breastfeeding","Current or recent clinically significant infection","Any history of inflammatory bowel disease","History of malignancy, except for non-melanoma skin cancer excised"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab, Guselkumab, or SDL-001. The registry lists allocation as randomized. This is a proof-of-concept study to see if antibodies (guselkumab and adalimumab) delivered directly to the colon can enter the systemic circulation.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 18 people at Maroochydore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.262Z"},{"nctId":"NCT07789340","title":"Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain","officialTitle":"Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain: A Randomized Single-Blinded Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Tanta University","sponsorClass":"OTHER","summary":"This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.","conditions":["Bipolar Radiofrequency Ablation","Unipolar Radiofrequency Ablation","Knee Osteoarthritis","Pain"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Unipolar radiofrequency ablation"},{"type":"PROCEDURE","name":"Bipolar radiofrequency ablation"}],"enrollment":64,"startDate":"2026-08-29","completionDate":"2027-06-01","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> 50 years.\n* Both genders.\n* Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA.\n* One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids.\n* Kellgren-Lawrence grade (II-IV).\n\nExclusion Criteria:\n\n* Chronic knee pain induced by infection, inflammation, tumors, and fractures.\n* Prior knee surgery.\n* Acute knee pain.\n* Connective tissue diseases.\n* Neurologic or psychiatric disorders.\n* Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months.\n* Anticoagulant medication.\n* Local infection of the site of intervention.\n* Cognitive impairment.","locations":[{"facility":"Tanta University","city":"Tanta","state":"El-Gharbia","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mohammed S Elsharkawy, MD","phone":"00201148207870","email":"mselsharkawy@med.tanta.edu.eg"}],"primaryOutcomes":["Proportion of successful responders with a reduction 50% of pain"],"hasResults":false,"conditionSlugs":["osteoarthritis"],"drugSlugs":[],"locationSlugs":["tanta-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Unipolar radiofrequency ablation for Bipolar Radiofrequency Ablation","inPlainEnglish":"This study aims to compare the how well it works of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.","whoItsFor":["Ages 50 Years to any","Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA","One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids","Kellgren-Lawrence grade (II-IV)"],"whoShouldSkip":["Chronic knee pain induced by infection, inflammation, tumors, and fractures","Prior knee surgery","Connective tissue diseases","Neurologic or psychiatric disorders","Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months","Anticoagulant medication","Local infection of the site of intervention"],"whatHappens":"If you join, the listed intervention(s) are Unipolar radiofrequency ablation, or Bipolar radiofrequency ablation. The registry lists allocation as randomized. This study aims to compare the how well it works of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 64 people at Tanta. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.729Z"},{"nctId":"NCT07789574","title":"Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations","officialTitle":"Efficacy of Asciminib in Chronic Phase CML Patients With T315I Mutations","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Thomas Ernst, Prof. Dr. med.","sponsorClass":"OTHER","summary":"This is a multi-center, prospective, single-arm, non-randomized, interventional phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation. All patients will be treated with asciminib 200 mg BID. 50 patients will be enrolled from approximately 20 study sites in Germany.","conditions":["Chronic Myeloid Leukemia (CML)"],"keywords":[],"interventions":[{"type":"DRUG","name":"asciminib 200 mg BID"}],"enrollment":50,"startDate":"2026-11","completionDate":"2030-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female patients with BCR::ABL1 positive CML in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven T315I mutations detected by Sanger sequencing or NGS.\n* Age ≥ 18 years old (no upper age limit is given)\n* ECOG performance status of ≤2.\n* Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN \\[lower limit of normal\\] and ≤ULN \\[upper limit of normal\\]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed.\n* AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia\n* Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia\n* Total bilirubin ≤1.5 x ULN, except known Gilbert disease\n* Serum creatinine ≤2 x ULN\n* Written informed consent prior to any study procedures being performed\n\nExclusion Criteria:\n\n* Pre-treatment with asciminib\n* BCR::ABL1 variants lacking ABL1 exon a2\n* Known impaired cardiac function, including any of the following:\n\n  * Congenital long QT syndrome\n  * History of or presence of clinically significant ventricular or atrial tachyarrhythmia\n  * QTc \\>450 msec on screening ECG\n  * Myocardial infarction within 12 months prior to starting therapy\n* Other clinically significant heart disease (e.g., unstable angina, congestive heart failure)\n* Acute or chronic viral hepatitis with moderate or severe hepatic impairment (Child-Pugh scores \\>6), even if controlled\n* Other concurrent uncontrolled medical conditions (e.g., active or uncontrolled infections, acute or chronic liver and renal disease) that could cause unacceptable safety risks or compromise compliance with the protocol\n* Impaired gastrointestinal function or disease that may alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting and diarrhea, malabsorption syndrome, small bowel resection or gastric by-pass surgery)\n* Known chronic pancreatitis\n* Concomitant medications known to be strong inducers or inhibitors of the CYP450 isoenzyme CYP3A4\n* Patients who have undergone major surgery ≤2 weeks prior to starting study drug or who have not recovered from side effects of such therapy\n* Patients who are pregnant or breastfeeding or women of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 14 days of study start. Post-menopausal women must be amenorrheic for at least 12 months in order to be considered of non-childbearing potential.\n* Male and female patients must agree to employ an effective method of birth control throughout the study and for up to 2 weeks following discontinuation of study drug. (It is required that sexually active men use condom during intercourse while taking the drug and for 2 weeks after stopping treatment and not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid. Female partners of male patients must be advised to use highly effective methods of contraception.)\n* Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory)\n* Active autoimmune disorder, including autoimmune hepatitis\n* Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention\n* hypersensitivity to the active ingredient asciminib or to any of the other ingredients listed according to the latest version of the SmPC\n* Patients unwilling or unable to comply with the protocol.","locations":[{"facility":"Uniklinik der RWTH Aachen","city":"Aachen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charite CVK","city":"Berlin","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Klinikum Chemnitz gGmbH","city":"Chemnitz","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden","city":"Dresden","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Hochschule Hannover","city":"Hanover","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Jena","city":"Jena","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Leipzig AöR","city":"Leipzig","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medizinische Fakultät Mannheim der Universität Heidelberg","city":"Mannheim","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Ulm","city":"Ulm","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christian Fabisch, Dr.","phone":"+49 3641 939 66 70","email":"estimation@med.uni-jena.de"}],"primaryOutcomes":["Rate of MR2 at 12 months"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["aachen-germany","berlin-germany","chemnitz-germany","dresden-germany","hamburg-germany","hanover-germany","jena-germany","leipzig-germany","mannheim-germany","ulm-germany"],"enrichment":{"headline":"Phase 2: testing asciminib 200 mg BID for Chronic Myeloid Leukemia (CML)","inPlainEnglish":"This is a multi-center, prospective, single-arm, non-randomly assigned, treatment phase II study of CML patients in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven BCR::ABL1 T315I mutation.","whoItsFor":["Ages 18 Years to any","Male or female patients with BCR::ABL1 positive CML in first or second chronic phase (i.e. after allogeneic stem cell transplantation) and proven T315I mutations detected by Sanger sequencing or NGS","Age ≥ 18 years old (no upper age limit is given)","how well you can do daily activities (ECOG score) of ≤2","Serum levels of potassium, magnesium, total calcium within the normal limits (≥LLN \\[lower limit of normal\\] and ≤ULN \\[upper limit of normal\\]). Correction of electrolytes levels with supplements to fulfil enrolment criteria is allowed","AST and ALT ≤2.5 x ULN or 5.0 x ULN if considered due to leukemia","Alkaline phosphatase ≤2.5 x ULN unless considered due to leukemia","Total bilirubin ≤1.5 x ULN, except known Gilbert disease"],"whoShouldSkip":["Pre-treatment with asciminib","BCR::ABL1 variants lacking ABL1 exon a2","Known impaired cardiac function, including any of the following:","Congenital long QT syndrome","History of or presence of clinically significant ventricular or atrial tachyarrhythmia","QTc \\>450 msec on screening ECG","Myocardial infarction within 12 months prior to starting therapy"],"whatHappens":"If you join, the listed intervention(s) are asciminib 200 mg BID. The registry lists allocation as na. This is a multi-center, prospective, single-arm, non-randomly assigned, treatment phase II study of CML patients in first or second chronic phase (i.e.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.816Z"},{"nctId":"NCT07789834","title":"Application of the Patient-reported Longitudinal Assessment Tool for OSA (PLATO) Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea","officialTitle":"Application of the PLATO Questionnaire in Oral Appliance Therapy for Obstructive Sleep Apnea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Nevada Dental Sleep","sponsorClass":"OTHER","summary":"Prospective, real-world observational study in a dental sleep practice to assess the feasibility of incorporating the PLATO into a dental sleep practice and applicability for patients who are undergoing oral appliance therapy for the treatment of obstructive sleep apnea(OSA).\n\nThe PLATO questionnaire was recently developed by the American Academy of Sleep Medicine specifically for use in patients with obstructive sleep apnea.","conditions":["Obstructive Sleep Apnea (OSA)","Oral Applliance Therapy"],"keywords":["Obstructive Sleep Apnea","Observational, Real World Study","PLATO Questionnaire","Oral Appliance Therapy"],"interventions":[{"type":"OTHER","name":"The study will assess the feasibility of incorporating the PLATO questionnaire into a dental sleep practice. The PLATO questionnaire was developed as a patient reported outcome measure"}],"enrollment":20,"startDate":"2026-10-01","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion Criteria\n\n* All ethnicities and genders\n* 18 years of age\n* AHI ≥5 ≤ 30\n* Dentally suitable for OAT\n* AHI \\> 30 if refusal or intolerance for CPAP therapy\n* Smartphone ( for home sleep test)\n* Only using oral appliance therapy (i.e., no combination therapy)\n\nExclusion Criteria:\n\n* Pregnancy\n* Use of home oxygen\n* Serious/uncontrolled illness (such as angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure, chronic respiratory illness), significant sleep-related disorder)\n* The investigator feels, for any reason, that the patient's participation may not be in their best interests\n* Any condition or circumstance that, in the opinion of the investigator, is likely to preclude study completion, prevent accurate data collection, or bias the results","locations":[{"facility":"Nevada Dental Sleep","city":"Henderson","state":"Nevada","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change from baseline of the PLATO questionnaire at the completion of the oral appliance titration period."],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["henderson-nevada"],"enrichment":{"headline":"Not a traditional drug phase: The study will assess the feasibility of incorporating the PLATO questionnaire into a dental sleep practice. The PLATO questionnaire was developed as a patient reported outcome measure for Obstructive Sleep Apnea (OSA)","inPlainEnglish":"Prospective, real-world watch-and-measure (no experimental treatment required) study in a dental sleep practice to assess the feasibility of incorporating the PLATO into a dental sleep practice and applicability for patients who are undergoing oral appliance therapy for the treatment of obstructive sleep apnea(OSA). The PLATO questionnaire was recently developed by the American Academy of Sleep Medicine specifically for use in patients with obstructive sleep apnea.","whoItsFor":["Ages 18 Years to any","All ethnicities and genders","Dentally suitable for OAT","AHI \\> 30 if refusal or intolerance for CPAP therapy","Smartphone ( for home sleep test)","Only using oral appliance therapy (i.e., no combination therapy)"],"whoShouldSkip":["Serious/uncontrolled illness (such as angina/myocardial infarction, cancer, stroke, dementia, congestive heart failure, chronic respiratory illness), significant sleep-related disorder)","The investigator feels, for any reason, that the patient's participation may not be in their best interests","Any condition or circumstance that, in the opinion of the investigator, is likely to preclude study completion, prevent accurate data collection, or bias the results"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20 people at Henderson. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.952Z"},{"nctId":"NCT07792681","title":"Efficacy and Safety of BR005-036C Tablets for the Acute Treatment of Migraine in Adults","officialTitle":"A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Study Evaluating the Efficacy and Safety of BR005-036C Tablets in the Acute Treatment of Migraine in Adults","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Brise Pharmaceuticals Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to compare the efficacy and safety of BR005-036C versus placebo in subjects with Acute Migraines","conditions":["Migraine, With or Without Aura"],"keywords":[],"interventions":[{"type":"DRUG","name":"BR005-036C"},{"type":"DRUG","name":"BR005-036C"},{"type":"DRUG","name":"Placebo"}],"enrollment":2079,"startDate":"2026-09-30","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female Participants aged 18 years or older.\n2. Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year.\n3. Onset age of migraine shall be less than 50 years old.\n4. At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit.\n5. Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit.\n6. Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.\n\nExclusion Criteria:\n\n1. Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia.\n2. Patient with clinically significant cardiovascular, cerebrovascular, hematological, endocrine, hepatic, renal, pulmonary, gastrointestinal, neurological or psychiatric disorders; patient with other confounding acute or chronic pain syndromes, dementia, epilepsy, or other diseases (other than migraine) that may interfere with study assessments.\n3. Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis.\n4. Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening.\n5. Abnormal electrocardiogram findings at screening: QTcF \\>450 msec for male subjects; QTcF \\>470 msec for female subjects.\n6. Patient with uncontrolled hypertension.\n7. History of alcohol or substance abuse within 6 months prior to screening.\n8. Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \\>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73 m².\n9. Use of CGRP receptor antagonists within 1 month prior to screening or randomization; use of anti-CGRP or anti-CGRP-receptor monoclonal antibodies within 6 months prior to screening or randomization.\n10. Use of acute migraine treatment medications for more than 10 days per month in 3 months prior to randomization (refer to Concomitant Medications section).","locations":[{"facility":"Baoji Central Hospital","city":"Shanxi","state":"Baoji","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology","city":"Inner Mongolia","state":"Baotou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking Union Medical College Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Friendship Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xuanwu Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"First Medical Center of Chinese PLA General Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Bengbu Medical College","city":"Anhui","state":"Bengbu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cangzhou Central Hospital","city":"Hebei","state":"Cangzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Jilin University","city":"Jilin City","state":"Changchun","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Changde First People's Hospital","city":"Hunan","state":"Changde","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Third Hospital of Changsha","city":"Hunan","state":"Changsha","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Changsha Central Hospital","city":"Hunan","state":"Changsha","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xiangya Hospital of Central South University","city":"Hunan","state":"Changsha","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Xiangya Hospital of Central South University","city":"Hunan","state":"Changsha","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Third Xiangya Hospital of Central South University","city":"Hunan","state":"Changsha","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fourth People's Hospital of Chongqing (Chongqing Emergency Medical Center)","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Chongqing Medical University","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chonggang General Hospital","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chongqing University Three Gorges Hospital","city":"Chongqing","state":"Chongqing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dalian Municipal Central Hospital, Affiliated to Dalian University of Technology","city":"Liaoning","state":"Dalian","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dazhou Central Hospital","city":"Sichuan","state":"Dazhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Guangdong Provincial People's Hospital","city":"Guangzhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Guangzhou First People's Hospital","city":"Guangdong","state":"Guangzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Guangzhou Medical University","city":"Guangdong","state":"Guangzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital, Zhejiang University School of Medicine","city":"Zhejiang","state":"Hangzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","city":"Zhejiang","state":"Hangzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Fourth Affiliated Hospital of Harbin Medical University","city":"Heilongjiang","state":"Harbin","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second People's Hospital of Hefei","city":"Anhui","state":"Hefei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Anhui Medical University","city":"Anhui","state":"Hefei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inner Mongolia Autonomous Region People's Hospital","city":"Inner Mongolia","state":"Hohhot","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huanggang Central Hospital","city":"Hubei","state":"Huanggang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huzhou Central Hospital","city":"Zhejiang","state":"Huzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Shandong","state":"Jinan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital","city":"Shandong","state":"Jinan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)","city":"Shandong","state":"Jinan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jingzhou First People's Hospital","city":"Hubei","state":"Jingzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Hospital of Jining Medical University","city":"Shandong","state":"Jining","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Kunming Medical University","city":"Yunnan","state":"Kunming","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Kunming Medical University","city":"Yunnan","state":"Kunming","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Lanzhou University","city":"Gansu","state":"Lanzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The 940th Hospital of PLA Joint Logistic Support Force","city":"Gansu","state":"Lanzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second People's Hospital of Lianyungang","city":"Jiangsu","state":"Lianyungang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Liaocheng People's Hospital","city":"Shandong","state":"Liaocheng","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science and Technology","city":"Henan","state":"Luoyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Jiangsu","state":"Nanjing","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)","city":"Jiangsu","state":"Nanjing","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nanjing Brain Hospital","city":"Jiangsu","state":"Nanjing","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Nanyang Medical College","city":"Henan","state":"Nanyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Qingdao Central Hospital","city":"Shandong","state":"Qingdao","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rizhao People's Hospital of Shandong Province","city":"Shandong","state":"Rizhao","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rui'an People's Hospital","city":"Zhejiang","state":"Ruian","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huashan Hospital, Fudan University","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Fourth People's Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaoyang Central Hospital","city":"Hunan","state":"Shaoyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"General Hospital of Northern Theater Command of Chinese PLA","city":"Liaoning","state":"Shenyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The People's Hospital of Liaoning Province","city":"Liaoning","state":"Shenyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen People's Hospital","city":"Guangdong","state":"Shenzhen","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shenzhen Second People's Hospital","city":"Guangdong","state":"Shenzhen","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hebei General Hospital","city":"Hebei","state":"Shijiazhuang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taihe Hospital, Shiyan","city":"Hubei","state":"Shiyan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Soochow University","city":"Jiangsu","state":"Suzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Soochow University","city":"Jiangsu","state":"Suzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin People's Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Xinjiang Medical University","city":"Xinjiang","state":"Urumqi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Renmin Hospital of Wuhan University","city":"Hubei","state":"Wuhan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Wuhan Third Hospital (Wuhan Tongren Hospital)","city":"Hubei","state":"Wuhan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhongnan Hospital of Wuhan University","city":"Hubei","state":"Wuhan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Wuxi People's Hospital","city":"Jiangsu","state":"Wuxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaanxi Provincial People's Hospital","city":"Shanxi","state":"Xi'an","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xi'an Gaoxin Hospital","city":"Shanxi","state":"Xi'an","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xi'an Medical University","city":"Shanxi","state":"Xi'an","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Xiamen University","city":"Fujian","state":"Xiamen","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xianyang Hospital of Yan'an University","city":"Shanxi","state":"Xianyang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Xuancheng People's Hospital","city":"Anhui","state":"Xuancheng","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Yinchuan","city":"Ningxia","state":"Yinchuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zaozhuang Municipal Hospital","city":"Shandong","state":"Zaozhuang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhengzhou People's Hospital","city":"Henan","state":"Zhengzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second People's Hospital of Zhengzhou","city":"Henan","state":"Zhengzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhengzhou University","city":"Henan","state":"Zhengzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhuzhou Central Hospital","city":"Hunan","state":"Zhuzhou","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First People's Hospital of Zigong","city":"Sichuan","state":"Zigong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brise Pharmaceuticals Co., Ltd.","phone":"+81-21-80517689","email":"ra@brisepharma.com"}],"primaryOutcomes":["Percentage of Participants with Freedom from Pain at 2 hours post-dose","Percentage of Participants with Freedom from Most Bothersome Symptom (MBS) at 2 hours post-dose"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["shanxi-china","inner-mongolia-china","beijing-china","anhui-china","hebei-china","jilin-city-china","hunan-china","chongqing-china","liaoning-china","sichuan-china","guangzhou-china","guangdong-china","zhejiang-china","heilongjiang-china","hubei-china","shandong-china","yunnan-china","gansu-china","jiangsu-china","henan-china","shanghai-china","tianjin-china","xinjiang-china","fujian-china","ningxia-china"],"enrichment":{"headline":"Phase 2 / Phase 3: testing BR005-036C for Migraine, With or Without Aura","inPlainEnglish":"This study wants to compare the how well it works and safety of BR005-036C versus dummy treatment (placebo) in subjects with Acute Migraines","whoItsFor":["Ages 18 Years to any","Male or female Participants aged 18 years or older","Patients diagnosed with migraine with or without aura in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3), with a disease history of at least 1 year","Onset age of migraine shall be less than 50 years old","At least 2-8 moderate-to-severe migraine attacks per month within 3 months prior to screening visit","Fewer than 15 headache days (migraine or non-migraine) per month within 3 months prior to screening visit","Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry"],"whoShouldSkip":["Patient with a history of or diagnosed with brainstem aura migraine, hemiplegic migraine, retinal migraine, new-daily-persistent headache, trigeminal autonomic cephalalgias or cranial neuralgia","Patient with a history of acute hepatitis within 6 months prior to screening, or any chronic liver diseases including non-alcoholic fatty liver disease, chronic viral hepatitis, liver cirrhosis","Patient with a history of hematological or solid malignant neoplasms within 5 years prior to screening","Abnormal electrocardiogram findings at screening: QTcF \\>450 msec for male subjects; QTcF \\>470 msec for female subjects","Patient with uncontrolled hypertension","History of alcohol or substance abuse within 6 months prior to screening","Clinically significant laboratory abnormalities at screening: ALT, AST or total bilirubin \\>1.5 × upper limit of normal (ULN); estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73 m²"],"whatHappens":"If you join, the listed intervention(s) are BR005-036C, BR005-036C, or Placebo. The registry lists allocation as randomized. This study wants to compare the how well it works and safety of BR005-036C versus dummy treatment (placebo) in subjects with Acute Migraines","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 2,079 people at 83 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.301Z"},{"nctId":"NCT07792837","title":"An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being","officialTitle":"Feasibility and Preliminary Effects of an Online Intuitive Eating Intervention on Gestational Weight Gain and Well-Being in Pregnant Women","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"San Diego State University","sponsorClass":"OTHER","summary":"The goal of this feasibility randomized controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main research questions are:\n\nRQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women? RQ2: How does participation in the Pregnancy Intuitive Eating Intervention (PIE-I) impact key maternal health outcomes (i.e., gestational weight gain, intuitive eating behaviors, dietary quality, body image, and mental health) compared to a wait-list control?\n\nResearchers will compare the Pregnancy Intuitive Eating Intervention (PIE-I) intervention group with the wait-list control to see what impact the PIE-I has on maternal well-being.\n\nParticipants randomized to the intervention group will complete the 8 week asynchronous IE intervention and have an opportunity to interview at the end of the study.","conditions":["Excessive Gestational Weight Gain","Pregnancy","INTUITIVE EATING","Perceived Stress","Prenatal Depression","Anxiety","Diet Quality","Physical Activity","Body Awareness"],"keywords":["Excessive Gestational Weight Gain","Obesity","Intuitive Eating","Pregnancy","Body Image","Body Appreciation","Gestational Weight Gain","Maternal Health"],"interventions":[{"type":"OTHER","name":"Intuitive Eating Intervention"}],"enrollment":80,"startDate":"2026-11","completionDate":"2027-08","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Pregnant women between 12 weeks and \\<22 weeks gestation\n* Pre-pregnancy BMI 30.0 kg/m² or greater\n* Able to read and understand English (for intervention materials and questionnaires)\n* Receiving prenatal care at UC San Diego Health (UCSD)\n* Reliable access to a device (e.g., smartphone, tablet, or computer) with internet connection\n\nExclusion Criteria:\n\n* Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, ARFID)\n* High-risk pregnancy or medical complications that may significantly affect diet, physical activity, or weight gain (e.g., gestational diabetes requiring insulin, preeclampsia, hyperemesis gravidarum)\n* Multiple gestation pregnancy (e.g., twins or higher-order multiples)\n* Current participation in another nutrition, weight management, or behavioral intervention study\n* Severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or current substance use disorder that would interfere with participation\n* Inability to provide informed consent or comply with study procedures","locations":[{"facility":"San Diego State University","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UC San Diego Health","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeni Green, PhD","phone":"619-594-6489","email":"jgreen5@sdsu.edu"}],"primaryOutcomes":["Intervention Acceptability as Assessed by the Post-Intervention Satisfaction Survey at 8 Weeks","Burden of the Intervention at 8 Weeks","Participant Retention Through the 8-Week Intervention","Participant Adherence to the Intervention During the 8-Week Intervention","Participant Engagement with the Intervention During the 8-Week Intervention"],"hasResults":false,"conditionSlugs":["obesity","depression"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: Intuitive Eating Intervention for Excessive Gestational Weight Gain","inPlainEnglish":"The goal of this feasibility randomly assigned controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity. The main research questions are: RQ1: What is the feasibility (acceptability and demand) of implementing an Intuitive Eating Intervention among pregnant and postpartum women?","whoItsFor":["Ages 18 Years to any","Women only","Pregnant women between 12 weeks and \\<22 weeks gestation","Pre-pregnancy body-mass index (BMI) 30.0 kg/m² or greater","Able to read and understand English (for intervention materials and questionnaires)","Receiving prenatal care at UC San Diego Health (UCSD)","Reliable access to a device (e.g., smartphone, tablet, or computer) with internet connection"],"whoShouldSkip":["Current or past diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, binge eating disorder, ARFID)","High-risk pregnancy or medical complications that may significantly affect diet, physical activity, or weight gain (e.g., gestational diabetes requiring insulin, preeclampsia, hyperemesis gravidarum)","Multiple gestation pregnancy (e.g., twins or higher-order multiples)","Current participation in another nutrition, weight management, or behavioral intervention study","Severe psychiatric illness (e.g., schizophrenia, bipolar disorder) or current substance use disorder that would interfere with participation"],"whatHappens":"If you join, the listed intervention(s) are Intuitive Eating Intervention. The registry lists allocation as randomized. The goal of this feasibility randomly assigned controlled trial is to assess the feasibility, acceptability, and demand, as well as preliminary effects of an evidence-based Intuitive Eating (IE) intervention among pregnant women who have obesity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.837Z"},{"nctId":"NCT07795554","title":"The Safety and Effectiveness of dTMS for Reducing Antipsychotic-induced Weight Gain","officialTitle":"The Effects of Improving Antipsychotic-induced Weight Gain by Accelerated dTMS After Food Cue-induced Craving, A Double-Blind, Randomized, Sham-Controlled Clinical Trial.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Second Xiangya Hospital of Central South University","sponsorClass":"OTHER","summary":"Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain. Recently, research suggest that Accelerated dTMS (a-dTMS) which deliver more than one daily TMS session indicates greater efficacy than other TMS treatment. Symptom provocation is believed to improve the clinical responses to TMS. In this study, the investigators, firstly, evaluate the safety and effectiveness of a-dTMS for reducing antipsychotic-induced weight gain and secondly, to establish a predictive model of therapeutic response and to explore the underlying mechanisms of dTMS for reducing antipsychotic-induced weight gain, based on multimodal radiomics and metabolomics approaches.","conditions":["Schizophrenia Spectrum","Schizophrenia","Antipsychotic Induced Weight Gain"],"keywords":["Schizophrenia","Antipsychotic induced weight gain","dTMS"],"interventions":[{"type":"DEVICE","name":"dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS"},{"type":"DEVICE","name":"Sham stimulation"}],"enrollment":60,"startDate":"2026-11-01","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged between 18-60.\n* Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).\n* Gaining body weight around 7% after intaking antipsychotics within 2 years.\n* Participants were on a stable medication regimen at the time of enrollment. ●Written informed consent was obtained from both the participants and their legally authorized guardians.\n\nExclusion Criteria:\n\n* Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.\n* Diagnosed with other mental diseases in accordance with DSM-V.\n* Comorbid with other severe physiological diseases.\n* Active suicidal ideation.\n* A history of alcohol or substance use disorder (or abuse).\n* Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI).\n* Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation.\n* Receipt of regular transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month.\n* Pregnant or lactating women","locations":[{"facility":"The Second Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"PING SHAO","phone":"+86-13755112445","email":"shp97jw@163.com"},{"name":"Renrong Wu","phone":"+86-15874179855","email":"wurenrong@csu.edu.cn"}],"primaryOutcomes":["Change in BMI","Change in body weight"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["changsha-china"],"enrichment":{"headline":"Not a traditional drug phase: dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS for Schizophrenia Spectrum","inPlainEnglish":"Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain.","whoItsFor":["Ages 18 Years to 60 Years","Aged between 18-60","Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)","Gaining body weight around 7% after intaking antipsychotics within 2 years"],"whoShouldSkip":["Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period","Diagnosed with other mental diseases in accordance with DSM-V","Comorbid with other severe physiological diseases","Active suicidal ideation","A history of alcohol or substance use disorder (or abuse)","Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)","Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation"],"whatHappens":"If you join, the listed intervention(s) are dTMS of accelerated intermittent theta burst stimulation, ACC-iTBS, or Sham stimulation. The registry lists allocation as randomized. Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Changsha. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.047Z"},{"nctId":"NCT07796061","title":"Blood-Brain Barrier Disruption Using Exablate Magnetic Resonance-Guided Low Intensity Focused Ultrasound With Microbubbles in Combination With T-Cell Infusion in Patients With Newly Diagnosed Diffuse Midline Glioma (LIFT)","officialTitle":"A Safety and Feasibility Study to Evaluate Blood-Brain Barrier Disruption Using Exablate MR-Guided Low Intensity Focused Ultrasound With Microbubbles in Combination With Preferentially Expressed Antigen of Melanoma (PRAME), Survivin, and Wilms Tumor 1 (WT1)-Targeting Tumor Associated Antigen-specific T-Cell Infusion in Patients With Newly Diagnosed Diffuse Midline Glioma (LIFT)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Children's National Research Institute","sponsorClass":"OTHER","summary":"This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for Diffuse Midline Glioma (DMG), an aggressive brain tumor with a very poor prognosis - an average one-year overall survival. This study combines blood-brain barrier (BBB) disruption (BBBD) using low-intensity focused ultrasound (LIFU) and microbubble treatment, and intravenous infusion of autologous, tumor multi-antigen associated specific cytotoxic T lymphocyte (TAA-T) therapy. The TAA-T cell investigational product in this protocol is manufactured to target Preferentially Expressed Antigen of Melanoma (PRAME), Wilms Tumor 1 (WT1), and survivin.","conditions":["DMG","DIPG"],"keywords":["Low-intensity focused ultrasound","microbubble treatment","blood-brain barrier disruption","T cell therapy","TAA-T cell therapy","LIFU","FUS"],"interventions":[{"type":"BIOLOGICAL","name":"TAA-T Cell"},{"type":"DEVICE","name":"BBB Disruption"}],"enrollment":45,"startDate":"2026-12","completionDate":"2031-12","sex":"ALL","minAge":"3 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion Criteria for Screening and Procurement:\n\n* Age ≥ 3 and ≤ 25 years\n* Diagnosis of pontine or thalamic DMG\n\n  * Group A: newly diagnosed pontine DMG after completion of standard radiation therapy; radiographic diagnosis is defined as tumors with a pontine epicenter and diffuse intrinsic involvement of the pons - tissue diagnosis is not required\n  * Group B: newly diagnosed thalamic DMG after completion of standard radiation therapy; tissue diagnosis is required NOTE: Tumor extending outside of the pons or the thalamus can remain eligible if the LIFU treatment is not contraindicated based on the neurosurgeon's assessment and the tumor does not meet any of the exclusion criteria below\n* The first procurement blood draw must occur between 4 and 14 weeks after completion of radiation therapy for Group A, and between 4 and 22 weeks after completion of radiation therapy for Group B\n* Lansky/Karnofsky rating ≥ 60 (participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status)\n* Head circumference ≥ 49 cm\n* Organ function:\n\n  * Hemoglobin ≥ 8 g/dL, unsupported\n  * Absolute Neutrophil Count (ANC) ≥750/μL\n  * Absolute Lymphocyte Count (ALC) \\>500/μL\n  * Platelets ≥75K, unsupported\n  * Total Bilirubin ≤3x upper limit of normal (ULN)\n  * AST/ALT ≤5x ULN\n  * Serum creatinine ≤1.0 mg/dL or ≤1.5x ULN for age (whichever is higher)\n  * Pulse oximetry \\>90% on room air\n* If the participant is on corticosteroids, the dose must be stable or decreasing for at least 7 days prior to procurement, and the treating investigator must anticipate that steroids can be weaned to ≤ 0.4 mg/m2/day of dexamethasone or equivalent by the start of the first LIFT protocol therapy cycle\n* Deemed to be of sufficient size (≥10 kg) to provide the necessary blood volume for TAA-T generation with no contra-indications to research blood draw, as determined by the treating PI/Sub-I\n* Adult participant or LAR of minor participant demonstrates willingness to have intracerebroventricular access device placed prior to initiation of LIFT protocol therapy, if a suitable Rickham, Ommaya, or accessible VP shunt is not already in place at study entry\n* For females of childbearing potential (FOCBP): negative pregnancy test within 7 days prior to procurement (urine or serum)\n* Adult participant or LAR of minor participant capable of providing informed consent. When appropriate, pediatric participants ≥7 years of age will participate in an age-appropriate discussion and provide assent, unless an IRB-approved waiver of assent applies and documentation of the participant's eligibility for the waiver is maintained\n\nInclusion Criteria for BBBD Procedure and TAA-T Infusion:\n\n* Lansky/Karnofsky rating ≥ 60 (participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status)\n* Group A: must have their initial planned LIFU and TAA-T infusion within 20 weeks from completion of radiation therapy; Group B: must have their initial planned LIFU and TAA-T infusion within 28 weeks from completion of radiation therapy\n* For participant with a history of prior intracranial surgery, at least 14 days must have elapsed since surgery and the participant must have fully recovered from acute surgical effects\n* For participant with a history of bevacizumab (Avastin) exposure, at least 28 days must have elapsed since the last dose\n* If on steroids, stable or decreasing dose ≤ 0.4 mg/m2/day of dexamethasone or equivalent on the date of eligibility confirmation for LIFT treatment\n* Stable or improving neurological status for ≥14 days prior to the date of eligibility confirmation for the first LIFU and TAA-T infusion, and for ≥7 days prior to the date of eligibility confirmation for subsequent cycles\n* Intracerebroventricular access device (such as an Ommaya or Rickham reservoir and catheter) or VP shunt present, and in a location that does not interfere with Exablate BBBD procedure\n* Organ function:\n\n  * Hemoglobin ≥ 8 g/dL, unsupported\n  * Absolute Neutrophil Count (ANC) ≥750/μL\n  * Platelets ≥75K, unsupported\n  * Normal coagulation studies: PT (\\<14 sec) or PTT (\\<36 sec), and INR (\\<1.2)\n  * Total Bilirubin ≤3x upper limit of normal (ULN)\n  * AST/ALT ≤5x ULN\n  * Serum creatinine ≤1.0mg/dL or ≤1.5x ULN for age (whichever is higher)\n  * Pulse oximetry \\>90% on room air\n* For FOCBP: negative pregnancy test (urine or serum)\n* Agree to use contraceptive measures for at least 6 months following final TAA-T infusion (when age appropriate)\n* Suitability for prolonged anesthesia for LIFU procedure, in the opinion of treating PI or qualified Sub-I\n* Agree to a brief course of steroids or bevacizumab or anti-cytokine agent/s if the treating investigator deems it clinically necessary in the context of clinical deterioration that may be attributed to the LIFT protocol therapy\n* Adult participant or LAR of a minor participant capable of providing informed consent. When appropriate, pediatric participants ≥7 years of age will participate in an age-appropriate discussion and provide assent, unless an IRB-approved waiver of assent applies and documentation of the participant's eligibility for the waiver is maintained\n* Adult participant or LAR of a minor participant must attest to the participant's ability to remain in close geographic proximity to CNH (within 60-mile radius) for the initial dose limiting toxicity (DLT) monitoring period, and for the first 14 days after each subsequent infusion\n\nExclusion Criteria:\n\nExclusion Criteria for Screening and Procurement:\n\n* Tumor not visible on any pre-LIFT therapy imaging\n* Previous participation in other conventional or investigational chemotherapy, molecularly targeted therapy, or immunotherapy (Exceptions: Temozolomide during radiation in Group B patients is allowed; Bevacizumab use is allowed)\n* Disseminated disease\n* Primary disease in the spinal cord\n* Clinical or radiologic evidence of increased intracranial pressure\n* For a participant with a ventricular peritoneal (VP) shunt or similar device: presence of a device that, in the judgment of the institutional neurosurgeon (based on a technical evaluation of the screening non-contrast CT imaging and Exablate system target mapping), would interfere with safe delivery of the Exablate BBBD procedure\n* Previous or current uncontrolled infection/s\n* Known HIV infection\n* Pregnant or lactating females\n* Prior allogeneic stem cell transplantation (patients who have received autologous stem cell infusions will remain eligible)\n* Unable to fit comfortably into the MRI scanner (generally greater than 114 kg)\n* History of a bleeding disorder or clinically significant coagulopathy at treating PI/Sub-I's discretion\n* Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis\n* Known hypersensitivity to gadolinium-based contrast agents that, in the judgment of the PI or Sub-I in consultation with Radiology, is not expected to be safely mitigated with standard premedication and supportive care measures\n* Known hypersensitivity to DEFINITY®, or its components (e.g., polyethylene glycol), or to other perflutren microsphere agent/s\n* History of severe allergy or hypersensitivity to a study product excipient (e.g., DMSO) that, in the judgment of the PI or Sub-I, cannot be adequately managed with standard supportive measures and would pose an unacceptable risk to the participant\n* Cardiac disease, anomalies, or unstable hemodynamics\n\n  * Left ventricular ejection fraction below the lower limit of normal, as defined by age per institutional standards\n  * History of a hemodynamically unstable cardiac arrhythmia\n* The planned sonication pathway to the tumor involves:\n\n  * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n  * Clips, or other non-MRI compatible metallic implanted objects in the skull or the brain, except for shunts\n* \"Overly bulky tumor\", defined as follows:\n\n  * Group A: tumor \\>5 cm in a single maximal dimension, or clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction as determined by the clinical investigator;\n  * Group B: tumor \\>6 cm in a single maximal dimension, or tumor causing uncal herniation\n* Tumor presenting with the following imaging characteristics:\n\n  * Edema and/or mass effect that causes hydrocephalus\n  * Necrosis within the tumor and the neurosurgeon cannot ensure that all areas of necrosis within the ultrasound sonication beam path can be avoided\n  * Evidence of a significant new hemorrhage following radiation therapy. Area of microhemorrhage (defined as less than 5 mm in diameter) in the treatment area can be acceptable but requires the review of the neurosurgeon\n\nExclusion Criteria for BBBD Procedure and TAA-T Infusion:\n\n* Tumor not visible on most recent pre-LIFT therapy imaging\n* Previous participation in other conventional or investigational chemotherapy, molecularly targeted therapy, or immunotherapy. (Exceptions: Temozolomide during radiation in Group B patients is allowed; Bevacizumab use is allowed)\n* Disseminated disease\n* Clinical and radiographic evidence of increased intracranial pressure\n* For a participant with a ventricular peritoneal (VP) shunt or similar device: presence of a device that, in the judgment of the institutional neurosurgeon (based on a technical evaluation of the screening non-contrast CT imaging and Exablate system target mapping), would interfere with safe delivery of the Exablate BBBD procedure\n* \"Overly bulky tumor\", defined as follows:\n\n  * Group A: tumor \\>5 cm in a single maximal dimension, or clinically significant swallowing dysfunction/dysphagia or prominent medullary dysfunction as determined by the clinical investigator;\n  * Group B: tumor \\>6 cm in a single maximal dimension, or tumor causing uncal herniation\n* Tumor presenting with the following imaging characteristics:\n* Edema and/or mass effect that causes hydrocephalus.\n* Necrosis within the tumor and the neurosurgeon cannot ensure that all areas of necrosis within the ultrasound sonication beam path can be avoided\n* Evidence of a significant new hemorrhage following radiation therapy. Area of microhemorrhage (defined as less than 5 mm in diameter) in the treatment area can be acceptable but requires the review of the neurosurgeon\n* Containing calcifications in the focused ultrasound sonication beam path and system tools cannot tailor the treatment around these calcification spots.\n* Confirmed radiographic progressive disease (for subsequent cycles, participants with pseudoprogression may continue to be eligible if they demonstrate radiographic stability relative to prior indeterminate scan)\n* The sonication pathway to the tumor involves:\n* More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp\n* Clips, or other non-MRI compatible metallic implanted objects in the skull or the brain, except for shunts\n* Anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., acetylsalicylic acid \\[ASA/aspirin\\], non-steroidal anti-inflammatory drugs \\[NSAIDs\\], statins) within washout period prior to treatment (There is no required washout for eligibility assessment, but patients should be off agents for at least 3 days at the time of LIFU procedure or until 5 half-lives of the agent, whichever is longer)\n* Immunosuppression (corticosteroids to prevent/treat brain edema are permitted)\n* Active seizure disorder or epilepsy (clinically significant seizures despite medical treatment) for a minimum of 4 weeks prior to first cycle/Exablate BBBD procedure captured by history\n* Evidence of cranial or systemic infection\n* Known HIV infection\n* For participants for whom PI or medically licensed sub-I have suspicion of changed cardiac function since their prior pre-treatment echocardiogram/ECG: Repeat echo/ECG is indicative of cardiac disease, anomalies, or unstable hemodynamics (including left ventricular ejection fraction below the lower limit of normal, as defined by age per institutional standards OR hemodynamically unstable cardiac arrhythmia)\n* History of a bleeding disorder or clinically significant coagulopathy at treating PI/Sub-I's discretion\n* Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis\n* Known hypersensitivity to gadolinium-based contrast agents that, in the judgment of the PI or Sub-I in consultation with Radiology, is not expected to be safely mitigated with standard premedication and supportive care measures\n* Known hypersensitivity to DEFINITY®, or its components (e.g., polyethylene glycol), or to other perflutren microsphere agent/s\n* History of severe allergy or hypersensitivity to a study product excipient (e.g., DMSO) that, in the judgment of the PI or Sub-I, cannot be adequately managed with standard supportive measures and would pose an unacceptable risk to the participant\n* Pregnant or lactating females","locations":[{"facility":"Children's National Hospital","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Luca Szalontay, MD","phone":"202-476-1725","email":"LSZALONTAY@childrensnational.org"},{"name":"Fahmida Hoq, MBBS","phone":"202-476-3634","email":"FHoq@childrensnational.org"}],"primaryOutcomes":["Safety Evaluation","Feasibility evaluation"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia"],"enrichment":{"headline":"Phase 1: testing TAA-T Cell for DMG","inPlainEnglish":"This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for Diffuse Midline Glioma (DMG), an aggressive brain tumor with a very poor prognosis - an average one-year overall survival. This study combines blood-brain barrier (BBB) disruption (BBBD) using low-intensity focused ultrasound (LIFU) and microbubble treatment, and intravenous infusion of autologous, tumor multi-antigen associated specific cytotoxic T lymphocyte (TAA-T) therapy.","whoItsFor":["Ages 3 Years to 25 Years","who can join for Screening and Procurement:","Age ≥ 3 and ≤ 25 years","Diagnosis of pontine or thalamic DMG","Group A: newly diagnosed pontine DMG after completion of standard radiation therapy; radiographic diagnosis is defined as tumors with a pontine epicenter and diffuse intrinsic involvement of the pons - tissue diagnosis is not required"],"whoShouldSkip":["The first procurement blood draw must occur between 4 and 14 weeks after completion of radiation therapy for Group A, and between 4 and 22 weeks after completion of radiation therapy for Group B","Lansky/Karnofsky rating ≥ 60 (participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status)","Head circumference ≥ 49 cm","Hemoglobin ≥ 8 g/dL, unsupported","Absolute Neutrophil Count (ANC) ≥750/μL","Absolute Lymphocyte Count (ALC) \\>500/μL","Platelets ≥75K, unsupported"],"whatHappens":"If you join, the listed intervention(s) are TAA-T Cell, or BBB Disruption. The registry lists allocation as randomized. This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for Diffuse Midline Glioma (DMG), an aggressive brain tumor with a very poor prognosis - an average one-year overall survival.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 45 people at Washington D.C.. Taking part typically means an infusion or injection of a biologic, using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.798Z"},{"nctId":"NCT07797933","title":"A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3","officialTitle":"A Universal Primary Care Based Intervention to Reduce Youth Overdose Risk Aim 3","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boston Medical Center","sponsorClass":"OTHER","summary":"Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.\n\nTo address the gap in evidence-based overdose prevention interventions for youth, the investigators propose a randomized controlled trial (RCT) to evaluate the efficacy of a brief universal overdose prevention intervention in pediatric primary care. Twenty-four providers and 624 youth patient participants randomized (at the provider level) will be enrolled to receive either the brief overdose prevention intervention or usual care will be enrolled.","conditions":["Overdose"],"keywords":["Brief overdose prevention","Naloxone","Youth patients","Health care providers","Primary care"],"interventions":[{"type":"BEHAVIORAL","name":"Brief youth overdose prevention education"},{"type":"OTHER","name":"Usual Standard of Care"}],"enrollment":648,"startDate":"2026-11","completionDate":"2029-08","sex":"ALL","minAge":"13 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nProviders:\n\n* Physicians and advanced practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center\n* ≥ 1 clinic session per week\n\nYouth:\n\n* Ages 13 - 26\n* Scheduled for a comprehensive physical exam (CPE) or follow-up clinical appointment with a provider who is participating in the trial\n* English or Spanish speaking\n\nExclusion Criteria:\n\nProviders:\n\n* Participated as an intervention provider in the R61 pilot RCT (H-45731)\n* Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)\n\nYouth:\n\n* Caregivers of youth ages 13-17 unable to provide informed consent or are not English speaking\n* Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research\n* Young adults ages 18-26 with a legal guardian\n* Any medical/psychiatric condition that causes acute distress and requires emergency evaluation\n* Under legal custody of the Department of Children and Families (DCF)\n* Participated in the intervention arm of the R61 pilot RCT (H-45731)","locations":[{"facility":"Boston Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Bagley, MD, MSc","phone":"(617) 414-7399","email":"sarah.bagley@bmc.org"},{"name":"Sarah Kosakowski, MPH","phone":"(617) 414-6906","email":"sarah.kosakowski@bmc.org"}],"primaryOutcomes":["Youth knowledge of risk associated with exposure to fentanyl and other emerging drugs"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Brief youth overdose prevention education for Overdose","inPlainEnglish":"Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit). However, currently there is no evidence-based intervention for pediatric primary care to reduce youth overdose risk and ensure youth can recognize and respond to an overdose.","whoItsFor":["Ages 13 Years to any","Physicians and advanced practice providers (nurse practitioners and physician assistants) within Pediatric Primary Care and Family Medicine at Boston Medical Center, NeighborHealth, and South Boston Community Health Center","≥ 1 clinic session per week","Scheduled for a comprehensive physical exam (CPE) or follow-up clinical appointment with a provider who is participating in the trial","English or Spanish speaking"],"whoShouldSkip":["Participated as an intervention provider in the R61 pilot RCT (H-45731)","Participated in the Community Advisory Board that assisted in the development of the intervention (H-45388)","Cognitive limitation or intellectual disability that in the opinion of their provider would not be able to complete the requirements of the research","Young adults ages 18-26 with a legal guardian","Any medical/psychiatric condition that causes acute distress and requires emergency evaluation","Under legal custody of the Department of Children and Families (DCF)","Participated in the intervention arm of the R61 pilot RCT (H-45731)"],"whatHappens":"If you join, the listed intervention(s) are Brief youth overdose prevention education, or Usual Standard of Care. The registry lists allocation as randomized. Between 2015 and 2019, overdose deaths translated to 1.25 million years of life lost among adolescents and young adults (youth) aged 12 to 24 years, and the percent change in fatal overdose rates among adolescents ages 14 to 18 was higher than adults between 2019 and 2020.3-5 Primary care providers are uniquely positioned to provide evidence-based information to youth to both improve awareness of overdose risk (individual benefit) and simultaneously ensure that youth are prepared to recognize and respond to an overdose (public health benefit).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 648 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.437Z"},{"nctId":"NCT07798063","title":"Effectiveness of Solution-Focused Therapy for Generalized Anxiety Disorder in Emerging Adults","officialTitle":"Effectiveness of Solution-Focused Therapy for Generalized Anxiety Disorder in Emerging Adults","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"International Islamic University, Islamabad","sponsorClass":"OTHER","summary":"This study will evaluate whether Solution-Focused Therapy (SFT) helps reduce symptoms of Generalized Anxiety Disorder (GAD) in emerging adults in Pakistan. Participants will first be screened to identify those with mild to moderate levels of GAD. Eligible participants will be randomly assigned to receive either SFT or be placed on a waitlist. The researcher will measure changes in anxiety symptoms before and after the intervention to determine whether SFT is effective for emerging adults with GAD in Pakistan.","conditions":["Generalized Anxiety Disorder (GAD)"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Solution-Focused Therapy"}],"enrollment":50,"startDate":"2026-01-05","completionDate":"2026-12-15","sex":"ALL","minAge":"18 Years","maxAge":"29 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria: Participants with mild to moderate scores of generalized anxiety disorder upon baseline assessment will be included in the study.\n\nExclusion Criteria: Individuals will be excluded if they reported a diagnosis of psychotic disorder, and those receiving psychotherapy or counseling for anxiety.","locations":[{"facility":"International Islamic University Islamabad (IIUI)","city":"Islamabad","state":"","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fariha Hayat, MS","phone":"+92 3365288229","email":"fariha.hayat87@gmail.com"}],"primaryOutcomes":["Generalized Anxiety Disorder 7-item (GAD-7)","Depression Anxiety Stress Scales - Short Form (DASS-21)"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["islamabad-pakistan"],"enrichment":{"headline":"Not a traditional drug phase: Solution-Focused Therapy for Generalized Anxiety Disorder (GAD)","inPlainEnglish":"This study will evaluate whether Solution-Focused Therapy (SFT) helps reduce symptoms of Generalized Anxiety Disorder (GAD) in emerging adults in Pakistan. Participants will first be screened to identify those with mild to moderate levels of GAD.","whoItsFor":["Ages 18 Years to 29 Years","Participants with mild to moderate scores of generalized anxiety disorder upon baseline assessment will be included in the study"],"whoShouldSkip":["Individuals will be excluded if they reported a diagnosis of psychotic disorder, and those receiving psychotherapy or counseling for anxiety"],"whatHappens":"If you join, the listed intervention(s) are Solution-Focused Therapy. The registry lists allocation as randomized. This study will evaluate whether Solution-Focused Therapy (SFT) helps reduce symptoms of Generalized Anxiety Disorder (GAD) in emerging adults in Pakistan.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Islamabad. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.355Z"},{"nctId":"NCT07798180","title":"Transauricular Neurostimulation for Abdominal Pain Due to DGBI","officialTitle":"Transauricular Neurostimulation for Irritable Bowel Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Nationwide Children's Hospital","sponsorClass":"OTHER","summary":"This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 participants will be enrolled, with a goal of 20 completing the study. Participants will use the device for at least one hour daily for 4 weeks and complete questionnaires through week 8. The study will assess adherence, retention, safety, and preliminary changes in abdominal pain, bowel symptoms, quality of life, and anxiety.","conditions":["Abdominal Pain (AP)","Disorders of Gut-brain Interaction"],"keywords":["transcutaneous auricular neurostimulation","neuromodulation","pediatric abdominal pain","DGBI"],"interventions":[{"type":"DEVICE","name":"Transcutaneous auricular neurostimulation"}],"enrollment":30,"startDate":"2025-10-23","completionDate":"2026-10-30","sex":"ALL","minAge":"12 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 12-18 years.\n* Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria.\n* Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week.\n* Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel.\n\nExclusion Criteria:\n\n* Medical or psychiatric condition that contraindicates transauricular neurostimulation or creates a safety risk.\n* Abnormal ear anatomy preventing earpiece placement.\n* Developmental delay.\n* Implanted electronic device or hearing aid.\n* Participation in another interventional trial.\n* Pregnancy\n* Unable to communicate in English.\n* Prisoner.\n* Change in medications used to treat abdominal pain or gastrointestinal symptoms within 2 weeks before enrollment. Participants must be on stable doses for at least 2 weeks before enrollment.","locations":[{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Peter Lu, MD","phone":"(614) 722-3421","email":"Peter.Lu@nationwidechildrens.org"},{"name":"Eduardo Castillo Leon, MD","phone":"617-722-3874","email":"eduardo.castilloleon@nationwidechildrens.org"}],"primaryOutcomes":["Treatment Adherence Rate","Study completion rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["columbus-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Transcutaneous auricular neurostimulation for Abdominal Pain (AP)","inPlainEnglish":"This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction. Up to 30 you would be enrolled, with a goal of 20 completing the study.","whoItsFor":["Ages 12 Years to 18 Years","Clinical diagnosis of an abdominal pain-related disorder of gut-brain interaction (DGBI) meeting Rome IV criteria","Average abdominal pain intensity ≥3 on a 0-10 scale and pain on at least 2 days per week","Proper fit of the Sparrow earpiece on the left ear, as determined by study personnel"],"whoShouldSkip":["Medical or psychiatric condition that contraindicates transauricular neurostimulation or creates a safety risk","Abnormal ear anatomy preventing earpiece placement","Developmental delay","Implanted electronic device or hearing aid","Participation in another treatment trial","Unable to communicate in English","Change in medications used to treat abdominal pain or gastrointestinal symptoms within 2 weeks before enrollment. Participants must be on stable doses for at least 2 weeks before enrollment"],"whatHappens":"If you join, the listed intervention(s) are Transcutaneous auricular neurostimulation. The registry lists allocation as na. This single-site, open-label pilot study will evaluate transcutaneous auricular neurostimulation using the Sparrow Link device as a treatment for adolescents aged 12 to 18 years with abdominal pain related to disorders of gut-brain interaction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Columbus. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.440Z"},{"nctId":"NCT07798570","title":"Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS)","officialTitle":"Observational Study With CICR-NAM as a Food for Special Medicinal Purposes in Post-COVID Syndrome (PCS)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University Hospital Schleswig-Holstein","sponsorClass":"OTHER","summary":"In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur. In an earlier nutritional study, patients with COVID-19 recovered their physical performance more quickly when taking nicotinamide (vitamin B3). Patients who responded to nicotinamide also developed post-COVID syndrome less frequently. At the University Hospital Schleswig-Holstein in Kiel, special nicotinamide tablets (CICR-NAM) were developed that release the active substance selectively in the lower intestine and have been shown to be very well tolerated in several studies.\n\nPatients with post-COVID syndrome and documented tryptophan deficiency may therefore take one tablet (500 mg) of CICR-NAM daily for up to approximately 4 months as a food for special medicinal purposes within the therapy groups of the outpatient clinic for patients with post-COVID syndrome at the University Hospital Schleswig-Holstein in Kiel. This intake is far below the Upper Level defined by the European Food Safety Authority for lifelong daily intake (900 mg per day). Therefore, there are no safety concerns. CICR-NAM intake is intended to complement the therapy group programme by supporting energy metabolism.","conditions":["Post COVID Syndrome Long Covid"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"CICR-NAM"}],"enrollment":100,"startDate":"2026-09-08","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* all sexes;\n* minimum age 18 years; no upper age limit;\n* post-COVID syndrome (PCS)\n* serum tryptophan \\<55 µmol/L (UKSH reference range: 48-109 µmol/L);\n* participation in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel.\n\nExclusion Criteria:\n\n* Known allergies or intolerances to any component of CICR-NAM;\n* inability to provide informed consent;\n* pregnancy or breastfeeding;\n* severe comorbid disease (especially renal insufficiency, uncontrolled autoimmune diseases, liver disease, or malignancy);\n* long-term use of higher doses of medications that raise gastric pH (for example proton pump inhibitors, H2 receptor antagonists, or antacids), as an increase in pH toward approximately 7 may cause premature release of nicotinamide from CICR-NAM;\n* use of supplements containing more than 20 mg nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, nicotinic acid, or NAD+ per daily dose.","locations":[{"facility":"University Hospital Schleswig Holstein","city":"Kiel","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lennart Reinke, Dr. med.","phone":"+49 431 500-22200","email":"lennartmichel.reinke@uksh.de"}],"primaryOutcomes":["Serum tryptophan level"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["kiel-germany"],"enrichment":{"headline":"Not a traditional drug phase: CICR-NAM for Post COVID Syndrome Long Covid","inPlainEnglish":"In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur. In an earlier nutritional study, patients with COVID-19 recovered their physical performance more quickly when taking nicotinamide (vitamin B3).","whoItsFor":["Ages 18 Years to any","minimum age 18 years; no upper age limit;","post-COVID syndrome (PCS)","serum tryptophan \\<55 µmol/L (UKSH reference range: 48-109 µmol/L);","participation in the therapy groups of the PCS outpatient clinic at UKSH Campus Kiel"],"whoShouldSkip":["Known allergies or intolerances to any component of CICR-NAM;","pregnancy or breastfeeding;","severe comorbid disease (especially renal insufficiency, uncontrolled autoimmune diseases, liver disease, or malignancy);","long-term use of higher doses of medications that raise gastric pH (for example proton pump inhibitors, H2 receptor antagonists, or antacids), as an increase in pH toward approximately 7 may cause premature release of nicotinamide from CICR-NAM;","use of supplements containing more than 20 mg nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, nicotinic acid, or NAD+ per daily dose"],"whatHappens":"If you join, the listed intervention(s) are CICR-NAM. The registry lists allocation as na. In patients with post-COVID syndrome, changes in tryptophan metabolism, energy metabolism, and the gut microbiome may occur.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Kiel. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.230Z"},{"nctId":"NCT07799428","title":"Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease","officialTitle":"Evaluating the Efficacy of Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease (IBD): An Interventional Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Anabio R&D","sponsorClass":"INDUSTRY","summary":"Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis. Although current therapies can control inflammation, many patients still experience recurrent symptoms, treatment resistance, adverse effects, and impaired quality of life. Probiotics represent a promising adjunctive approach for IBD by restoring gut microbial balance, modulating mucosal immunity, supporting intestinal barrier function, and potentially improving symptoms while reducing unnecessary reliance on antibiotics or intensive treatments.\n\nIn this study, researchers propose that oral supplementation with multi-strain Bacillus spore probiotics, when used in combination with standard IBD treatment, is safe and may provide additional clinical benefits by improving gastrointestinal symptoms, quality of life, and disease activity in patients with IBD.\n\nThe objective of this study is to evaluate the safety and efficacy of Bacillus spore probiotics, including LiveSpo® COLON and LiveSpo® DIA30, in patients with inflammatory bowel disease. LiveSpo® COLON contains Bacillus subtilis ANA3 and Bacillus clausii ANA39 at a concentration of 3 × 10⁹ CFU/5 mL, while LiveSpo® DIA30 contains Bacillus subtilis ANA48, Bacillus clausii ANA39, and Bacillus coagulans ANA40 at a concentration of 5 × 10⁹ CFU/5 mL.\n\nStudy Design:\n\n* Sample Size: 150 participants\n* Study Location: Department of Gastroenterology\n\nIntervention Description: A total of 150 eligible participants will be randomly assigned to three groups (n = per group).\n\n* The Placebo Group will receive standard IBD treatment combined with oral RO water, one ampoule per dose, three times daily for 30 consecutive days.\n* The COLON Group will receive standard IBD treatment combined with LiveSpo® COLON, one ampoule per dose, three times daily for 30 consecutive days\n* The DIA30-COLON Group will receive standard IBD treatment combined with LiveSpo® DIA30, one ampoule per dose, three times daily for the first 14 days, followed by LiveSpo® COLON, one ampoule per dose, three times daily for the next 16 days.\n\nAll participants in the three groups will receive blinded, coded study products. Patients in all groups will follow the standard IBD treatment regimen of the hospital and use the assigned study products throughout the study period. Caregivers or clinical staff will monitor the health status of participants and record relevant information in their medical records. During the study, participants will be instructed not to use any additional probiotic products or solutions containing similar components.\n\nStudy Duration: 12 months.","conditions":["Crohn Disease and Ulcerative Colitis"],"keywords":["probiotics","spore","Bacillus","Inflammatory Bowel Disease"],"interventions":[{"type":"OTHER","name":"RO"},{"type":"COMBINATION_PRODUCT","name":"LiveSpo® DIA30"},{"type":"COMBINATION_PRODUCT","name":"LiveSpo® COLON"}],"enrollment":150,"startDate":"2026-09-04","completionDate":"2027-07-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 65 years.\n* Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital.\n* Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* Withdrawal from the study before completing 14 days of treatment.\n* Inability to comply with study procedures or inability to ensure adherence to the investigational product, as assessed by the investigator.\n* Moderate to severe hepatic or renal dysfunction, or other moderate to severe chronic cardiovascular, pulmonary, hepatic, or renal diseases that may affect general health status or require specialist treatment.\n* Presence of immune-related diseases.\n* Current use, or use within 4 weeks prior to screening, of biologic immunosuppressive therapies (for example, anti-TNF-α agents or vedolizumab).","locations":[{"facility":"Department of Gastroenterology","city":"Hà Nội","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anh N Tran, Assoc.Prof.","phone":"(84)904831512","email":"anhtn69@yahoo.com"},{"name":"Chi T Nguyen, MD, Specialist II","phone":"(84)912153567","email":"chint0366@hmuh.vn"}],"primaryOutcomes":["Change in IBD-related quality of life"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["h-n-i-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: RO for Crohn Disease and Ulcerative Colitis","inPlainEnglish":"Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis. Although current therapies can control inflammation, many patients still experience recurrent symptoms, treatment resistance, adverse effects, and impaired quality of life.","whoItsFor":["Ages 18 Years to 65 Years","Age 18 to 65 years","Confirmed diagnosis of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, according to the routine diagnostic procedures of Hanoi Medical University Hospital","Receiving examination and treatment at Hanoi Medical University Hospital (including both inpatients and outpatients), with a minimum treatment or follow-up duration of 14 days"],"whoShouldSkip":["Refusal to participate in the study","Withdrawal from the study before completing 14 days of treatment","Inability to comply with study procedures or inability to ensure adherence to the investigational product, as assessed by the investigator","Moderate to severe hepatic or renal dysfunction, or other moderate to severe chronic cardiovascular, pulmonary, hepatic, or renal diseases that may affect general health status or require specialist treatment","Presence of immune-related diseases","Current use, or use within 4 weeks prior to screening, of biologic immunosuppressive therapies (for example, anti-TNF-α agents or vedolizumab)"],"whatHappens":"If you join, the listed intervention(s) are RO, LiveSpo® DIA30, or LiveSpo® COLON. The registry lists allocation as randomized. Inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease, is a chronic relapsing intestinal disorder driven by immune dysregulation, impaired mucosal barrier function, and gut microbiome dysbiosis.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at Hà Nội. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.218Z"},{"nctId":"NCT07800754","title":"A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Everyday Medical Practice","officialTitle":"Epidemiological Characteristics And Management Strategies Of Gastric/Gastrophaegal Junction Cancer Patients In Routine Clinical Practice: A Greek Multicenter Observational Study (The GRACE Study)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This is a retrospective-prospective observational, multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.","conditions":["Gastric Cancer","Gastroesophageal Junction Cancer"],"keywords":["Gastric Cancer","Gastroesophageal Junction Cancer","Adenocarcinoma","Observational Study","Real-World Evidence","Epidemiology","Treatment Patterns","Greece"],"interventions":[],"enrollment":300,"startDate":"2026-09-30","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"130 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis.\n* Written signed and dated informed consent by the patient (or their legally acceptable representative, as applicable). For deceased patients on the date of study entry a waiver of consent must be approved by the Hospital EC/IRB.\n* Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027).\n\nExclusion Criteria:\n\n* Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice.\n* Patients who have participated in the design and/or the conduct of the study.\n* Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer.","locations":[{"facility":"Research Site","city":"Alexandroupoli","state":"","country":"Greece","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Athens","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Crete","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ioannina","state":"","country":"Greece","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Pátrai","state":"","country":"Greece","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Thessaloniki","state":"","country":"Greece","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["Distribution of GC/GEJ cancer types","Clinicopathological characteristics of patients with histologically confirmed stage II to IVB gastric/GEJ cancer.","To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma.","To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma, measured as frequencies per stage","Estimation of key time intervals, measured by time (months) from diagnosis to neoadjuvant or perioperative treatment and/or surgery (if applicable)","Estimation of key time intervals, measured by time (months) from surgery to adjuvant systemic treatment (for Stage II-IVA)","Estimation of key time intervals, measured by time (months) from first to second-line.","Estimation of key time intervals, measured by time (months) from second-line to third-line systemic treatment (for Stage IVB).","Duration of each systemic treatment line (overall and by type: chemotherapy, targeted therapy/immunotherapy; up to 3rd line)","Description of dosing schemes","To capture the current treatment strategies of patients with stage II to IVB gastric/GEJ adenocarcinoma."],"hasResults":false,"conditionSlugs":["stomach-cancer"],"drugSlugs":[],"locationSlugs":["alexandroupoli-greece","athens-greece","crete-greece","ioannina-greece","p-trai-greece","thessaloniki-greece"],"enrichment":{"headline":"A Study in Greece Observing How Patients With Stomach and Esophageal Cancer Are Diagnosed and Treated in Ev…","inPlainEnglish":"This is a retrospective-prospective watch-and-measure (no experimental treatment required), multicenter, single-country study aiming to describe the epidemiological characteristics and management strategies in patients with stage II-IVB gastric/GEJ adenocarcinoma in routine clinical practice in Greece.","whoItsFor":["Ages 18 Years to 130 Years","Patients aged ≥18 years upon gastric/GEJ adenocarcinoma diagnosis","Patients diagnosed with histologically confirmed, stage II to IVB adenocarcinoma of gastric/GEJ, between June 1st, 2025 and the end of the recruitment period (Q3 2027)"],"whoShouldSkip":["Patients who participate or participated during the data collection period (prospective and retrospective) in any clinical investigation/clinical trial that includes interventions that fall outside the everyday clinical practice","Patients who have participated in the design and/or the conduct of the study","Patients with another primary malignancy within the last 5 years, for which systemic anticancer treatment is required after the diagnosis of gastric/GEJ cancer"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 6 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.968Z"},{"nctId":"NCT07801495","title":"A Study to Assess the Efficacy, Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis","officialTitle":"A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2a/b Study Assessing the Efficacy, Safety and Tolerability of DDY391 in Participants With Active Moderate to Severe Psoriatic Arthritis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"The purpose of this Phase 2a/b study is:\n\n1. to evaluate the efficacy, safety and tolerability of DDY391 in participants with psoriatic arthritis (PsA).\n2. to determine the dose-response relationship of DDY391 in participants with PsA to support dose selection for Phase 3.","conditions":["Moderate to Severe Psoriatic Arthritis"],"keywords":["Psoriatic arthritis","Psoriasis","bDMARD","csDMARD","ACR50","Molecular Glue Degrader","VAV1"],"interventions":[{"type":"DRUG","name":"DDY391"},{"type":"DRUG","name":"Placebo"}],"enrollment":220,"startDate":"2026-10-19","completionDate":"2028-12-13","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Female or male participants at least 18 years of age.\n* Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening.\n* Moderate to severe PsA at screening and baseline.\n\nKey Exclusion Criteria:\n\n* Presence of inflammatory conditions other than psoriasis or PsA including but not limited to those associated with arthralgia or arthritis (e.g., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, sarcoidosis) or presence of fibromyalgia or osteoarthritis with articular symptoms.\n* Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer\n* Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline.\n* Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline.\n* History of lymphoproliferative disease or any known malignancy or history of malignancy of any organ system within the past 5 years (except for basal cell carcinoma or actinic keratosis that have been treated with no evidence of recurrence in the past 3 months, carcinoma in situ of the cervix or non-invasive malignant colon polyps that have been removed).\n* Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Newport Huntington Medical Group","city":"Huntington Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Altoona Center for Clin Res","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"WCG CR Philadelphia LLC","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shelby Research LLC","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Precision Comprehensive Research","city":"Colleyville","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arthritis Care of Texas","city":"Corpus Christi","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biopharma Informatic LLC","city":"Katy","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rheumatology Associates of South Texas","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Part A: Number of participants achieving American College of Rheumatology 50 (ACR50) response","Part A and B: Number of participants achieving American College of Rheumatology 50 (ACR50) response"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["huntington-beach-california","duncansville-pennsylvania","philadelphia-pennsylvania","memphis-tennessee","colleyville-texas","corpus-christi-texas","katy-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 2: testing DDY391 for Moderate to Severe Psoriatic Arthritis","inPlainEnglish":"The purpose of this Phase 2a/b study is: 1. to measure the how well it works, whether it is safe and how hard side effects are to live with of DDY391 in participants with psoriatic arthritis (PsA).","whoItsFor":["Ages 18 Years to 100 Years","Female or male participants at least 18 years of age","Diagnosis of PsA and meeting classification criteria for Psoriatic arthritis (CASPAR) at screening","Moderate to severe PsA at screening and baseline"],"whoShouldSkip":["Use of bDMARD treatment within 4 weeks or 5 half-lives of randomization, whichever is longer","Prior use of JAK inhibitors or TYK2 inhibitors (e.g., deucravacitinib). Prior use of apremilast is allowed but must not be taken within 4 weeks of baseline","Previous treatment with any cell-depleting therapies, including but not limited to anti-CD20, unless ≥ 12 months prior to baseline","Any active viral, bacterial or other infections at the time of screening or randomization, or history of recurrent clinically significant infection or of recurrent bacterial infections","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are DDY391, or Placebo. The registry lists allocation as randomized. The purpose of this Phase 2a/b study is: 1.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 220 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.570Z"},{"nctId":"NCT07801703","title":"Behavioural Activation Therapy and Ketamine for Treatment-Resistant Depression","officialTitle":"Optimizing the Synergy Between Behavioural Activation Therapy and Intravenous Ketamine for Treatment-Resistant Depression","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"The Royal's Institute of Mental Health Research","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.\n\nWe aim to find out whether participants who receive both treatments:\n\n1. Have greater reductions in depression symptoms than those who receive ketamine only\n2. Have better response and remission rates than those who receive ketamine only\n3. Experience better overall functioning, including mood, anxiety, quality of life, and physical activity than those who receive ketamine only\n\nParticipants will be randomized to one of two groups: Arm 1) concurrent ketamine and BA therapy started from treatment initiation, or Arm 2) ketamine treatment alone.\n\n* All participants will undergo IV ketamine infusions administered twice weekly for three weeks.\n* Half of the participants in will also undergo BA therapy sessions twice weekly for three weeks.\n* Individuals with a sufficient treatment response after 3 weeks will proceed to undergo an additional 12 weeks of ketamine infusions (and those receiving BA therapy will continue to receive therapy for an additional 12 weeks).","conditions":["Treatment Resistant Depression","Major Depressive Disorder (MDD)"],"keywords":["Treatment Resistant Depression","Major Depressive Disorder","Ketamine","Behavioural Activation Therapy","Psychotherapy"],"interventions":[{"type":"DRUG","name":"Ketamine (0.5 mg/kg)"},{"type":"BEHAVIORAL","name":"Behavioural Activation Therapy"}],"enrollment":60,"startDate":"2026-10-30","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. English speaking\n2. Age 18-65 at Screening\n3. Meeting criteria for major depressive disorder (MDD), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)\n4. Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode\n5. Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening\n6. Be under the care of a designated health care provider (e.g., family physician or psychiatrist) to follow their care after the completion of the study\n7. Willing to maintain stable doses of concomitant psychotropic medications throughout the study\n8. Willing to abstain from taking prohibited medications on the days of treatment (i.e., for 12 hours prior to treatment) as per study physician instruction (e.g., benzodiazepines, cannabis)\n9. Able to secure a ride/chaperone home from all ketamine infusions.\n\nExclusion Criteria:\n\n1. Body mass index (BMI) ≥35\n2. Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement\n3. Not medically cleared to receive ketamine treatment due to presence of clinically relevant disease, per study physician judgement (e.g., uncontrolled hypertension, renal or hepatic impairment, significant coronary artery disease, vascular disease, diabetes mellitus, seizure disorder, intracerebral hemorrhage, history of cerebrovascular accident \\[CVA\\])\n4. Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance\n5. History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\\<2 years) acute episode of psychosis\n6. Current and/or recent history (\\<12 months) of substance use disorder/dependence (except for alcohol, cannabis, caffeine or nicotine) as defined by DSM-5 criteria\n7. Current and/or recent history (\\<6 months) of cannabis use disorder as defined by DSM-5 criteria, or unable to abstain from using cannabis 12 hours before and 12 hours after each ketamine infusion\n8. Current and/or recent history (\\<6 months) of alcohol use disorder as defined by DSM-5 criteria, or unable to abstain from using alcohol 12 hours before and 12 hours after each ketamine infusion\n9. Concurrent use of ketamine or psychedelics in any form\n10. A previous history or known diagnosis of major neurocognitive disorder\n11. Known or suspected history of intolerance, allergy or hypersensitivity to ketamine\n12. Any other condition or circumstance that, in the opinion of the QI/study physicians, would adversely affect the participant's ability to complete the study procedures or its measures\n13. Concurrent psychotherapy treatment outside the clinical trial. A participant may opt to pause or terminate their current ongoing psychotherapy to participate in the study, at their own discretion.\n14. Concurrent active electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) therapy.","locations":[{"facility":"The Royal","city":"Ottawa","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Coordinator","phone":"613-722-6521","email":"suwojcik@theroyal.ca"}],"primaryOutcomes":["Change in MADRS from Baseline"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":["ketamine"],"locationSlugs":["ottawa-canada"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Ketamine (0.5 mg/kg) for Treatment Resistant Depression","inPlainEnglish":"The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone. We aim to find out whether participants who receive both treatments: 1.","whoItsFor":["Ages 18 Years to 65 Years","Age 18-65 at Screening","Meeting criteria for major depressive disorder (major depression), in a major depressive episode without psychotic symptoms according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5)","Have not responded adequately to at least two separate courses of treatment with different antidepressants, each of adequate dose and duration, in the current depressive episode","Currently in a moderate to severe depressive episode, with a minimum MADRS score of ≥22 at Screening","Be under the care of a designated health care provider (e.g., family physician or psychiatrist) to follow their care after the completion of the study","Willing to maintain stable doses of concomitant psychotropic medications throughout the study","Willing to abstain from taking prohibited medications on the days of treatment (i.e., for 12 hours prior to treatment) as per study physician instruction (e.g., benzodiazepines, cannabis)"],"whoShouldSkip":["Body mass index (body-mass index (BMI)) ≥35","Depression secondary to a stroke, cancer, or other clinically significant medical illness, per study physician judgement","Pregnant, breastfeeding or of childbearing potential and unwilling to use an approved method of contraception during the study, as assessed during the Screening Visit medical clearance","History of a primary psychotic disorder (e.g., schizophrenia), or current or recent (\\<2 years) acute episode of psychosis","Current and/or recent history (\\<12 months) of substance use disorder/dependence (except for alcohol, cannabis, caffeine or nicotine) as defined by DSM-5 criteria","Current and/or recent history (\\<6 months) of cannabis use disorder as defined by DSM-5 criteria, or unable to abstain from using cannabis 12 hours before and 12 hours after each ketamine infusion","Current and/or recent history (\\<6 months) of alcohol use disorder as defined by DSM-5 criteria, or unable to abstain from using alcohol 12 hours before and 12 hours after each ketamine infusion"],"whatHappens":"If you join, the listed intervention(s) are Ketamine (0.5 mg/kg), or Behavioural Activation Therapy. The registry lists allocation as randomized. The goal of this clinical trial is to see if combining ketamine with behavioral activation (BA) therapy to treat moderate to severe treatment-resistant depression improves depressive symptoms and general functioning more than ketamine alone.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 60 people at Ottawa. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.102Z"},{"nctId":"NCT07802184","title":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Metastatic PDAC","officialTitle":"GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Metastatic Pancreatic Ductal Adenocarcinoma: A Single-Center, Open-Label, Phase Ib/II Trial","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"West China Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma.","conditions":["Metastatic Pancreatic Cancer"],"keywords":["Metastatic pancreatic cancer","SHR-1701","Apatinib","GnP"],"interventions":[{"type":"DRUG","name":"SHR-1701"},{"type":"DRUG","name":"Apatinib"},{"type":"DRUG","name":"gemcitabine"},{"type":"DRUG","name":"Nab-paclitaxel"}],"enrollment":45,"startDate":"2026-09-21","completionDate":"2029-01-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\) Age 18-75 years, regardless of sex; 2) patients with histologically confirmed pancreatic ductal adenocarcinoma (PDAC); 3) previously untreated patients with metastatic PDAC, with at least one measurable lesion according to RECIST v1.1, and target lesions must not have received prior radiotherapy or local treatment; 4) ECOG performance status of 0-1; 5) life expectancy ≥3 months; 6) willingness to comply with study procedures and able to receive treatment and undergo follow-up; 7) adequate major organ function, with laboratory test results meeting the following criteria within 7 days before enrollment: white blood cell (WBC) count ≥2.5×10⁹/L, absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet (PLT) count ≥75×10⁹/L, hemoglobin (HGB) ≥90 g/L (without blood transfusion or erythropoietin \\[EPO\\] dependence within 7 days), total bilirubin (TBIL) ≤1.5× the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN, albumin ≥30 g/L, international normalized ratio (INR) ≤1.5×ULN, serum creatinine (Cr) ≤1.5×ULN, and urinary protein ≤1+; 8) patients who are hepatitis B surface antigen (HBsAg)-positive with a peripheral blood hepatitis B virus DNA (HBV-DNA) level ≤1×10³/L; patients who are HBsAg-positive with a peripheral blood HBV-DNA level ≥1×10³/L may also be eligible if, in the investigator's judgment, chronic hepatitis B is clinically stable and does not increase the patient's risk; 9) voluntary participation in the study and provision of written informed consent.\n\nExclusion Criteria:\n\n1\\) Known hypersensitivity to any study drug; 2) known or suspected central nervous system metastases, defined as signs or symptoms suggestive of CNS metastasis, unless CNS metastasis has been excluded by CT or MRI; 3) history of other malignancies within 5 years, except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix; 4) requiring any concomitant anticancer treatment other than the study treatment during the study, including chemotherapy, targeted therapy, hormonal therapy, immunotherapy, radiotherapy, or traditional Chinese medicine with antitumor activity; 5) prior or current treatment with chemotherapy, FAK inhibitors, or antibodies targeting PD-1, PD-L1, PD-L2, CD137, or cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), including ipilimumab or any other antibody or drug targeting T-cell costimulatory or checkpoint pathways; 6) diagnosis of immunodeficiency or chronic systemic corticosteroid therapy (prednisone \\>10 mg/day or equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment; 7) receipt of a live vaccine within 30 days before the first dose of study treatment, including but not limited to measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccines; inactivated seasonal influenza vaccines are permitted, whereas live attenuated vaccines such as intranasal influenza vaccines (e.g., FluMist) are not permitted; 8) uncontrolled hypertension, defined as systolic blood pressure \\>160 mmHg and/or diastolic blood pressure \\>100 mmHg despite treatment; 9) significant cardiac disease, including congestive heart failure (NYHA class III-IV), previous myocardial infarction, or uncontrolled angina within 6 months; 10) clinically significant arrhythmias requiring treatment, including atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, or ECG abnormalities confirmed on repeat examination that, in the investigator's judgment, require clinical intervention or treatment; 11) history of hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major tumor-related bleeding; 12) surgery required within 28 days before or anticipated within 28 days after the last dose of study treatment; 13) uncontrolled third-space fluid accumulation, such as large pleural effusion or ascites; 14) definite gastrointestinal bleeding tendency within 4 weeks before the first dose, including: ① active localized ulcerative lesions with positive fecal occult blood; ② melena or hematemesis within 28 days; or ③ positive fecal occult blood in patients with unresected tumor invasion of the gastrointestinal tract who, in the opinion of the principal investigator at the study center, may be at risk of major gastrointestinal bleeding; 15) previous gastrointestinal perforation or suspected risk of gastrointestinal perforation, or intestinal obstruction; 16) concomitant medications that, in the investigator's judgment, are required during the trial and may affect the metabolism of the investigational drug, such as strong CYP3A4 inhibitors or inducers, or drugs with a narrow therapeutic index that are primarily metabolized by CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2D6; 17) severe psychiatric disorders; 18) women who are pregnant, breastfeeding, or potentially pregnant; 19) women or men of childbearing potential unwilling to use effective contraception during the study and for 3 months after the last dose of study treatment; 20) participation in another clinical trial of a drug or medical device within 4 weeks before enrollment; 21) any other condition that, in the investigator's judgment, makes the patient unsuitable for enrollment.","locations":[{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dan Cao","phone":"+8618980605963","email":"caodan@scu.edu.cn"},{"name":"Min Ren","phone":"","email":""}],"primaryOutcomes":["Recommended Phase II Dose (RP2D)","Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["chengdu-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing SHR-1701 for Metastatic Pancreatic Cancer","inPlainEnglish":"The goal of this clinical trial is to measure the safety and how well it works of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma.","whoItsFor":["Ages 18 Years to 75 Years"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are SHR-1701, Apatinib, or gemcitabine. The registry lists allocation as na. The goal of this clinical trial is to measure the safety and how well it works of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 45 people at Chengdu. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.438Z"},{"nctId":"NCT07803536","title":"Effect of Late Ripcord Removal From Glaucoma Drainage Device","officialTitle":"Prospective, Single-arm Interventional Study to Determine Effect of Late Ripcord Removal From Glaucoma Drainage Device","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Duke University","sponsorClass":"OTHER","summary":"This is a research study to find out if removing the ripcord from a glaucoma drainage device more than 3 months after it has been placed has any effect on intraocular pressure. Participation in research studies is voluntary.\n\nThe ripcord will be removed at a routine glaucoma care visit and intraocular pressure will be measured before removal, 30 minutes following, and at 1 week, 6 weeks and 3-month intervals during regular clinic visits.","conditions":["GLAUCOMA 1, OPEN ANGLE, D (Disorder)","Glaucoma"],"keywords":["glaucoma drainage device","ripcord"],"interventions":[{"type":"PROCEDURE","name":"Ripcord removal"}],"enrollment":80,"startDate":"2026-12","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> 18 years\n* Placement of Ahmed Clear Path or Baervelt drainage device with ripcord \\> 3 months\n* Diagnosis of Glaucoma, under active management at Duke Eye Center Glaucoma Clinic\n* Ripcord suture still in place and accessible for removal\n* Able to provide written informed consent\n* IOP \\> 10 mm Hg\n\nExclusion Criteria:\n\n* Active ocular infection or conjunctivitis in either eye\n* Inability to undergo ripcord removal procedure\n* Scheduled for further glaucoma surgery","locations":[{"facility":"Duke University Eye Center","city":"Durham","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jonathan Shepherd","phone":"(919) 681-3937","email":"j_shepherd0829@email.campbell.edu"}],"primaryOutcomes":["Change in intraocular pressure (IOP)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["durham-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: Ripcord removal for GLAUCOMA 1, OPEN ANGLE, D (Disorder)","inPlainEnglish":"This is a research study to find out if removing the ripcord from a glaucoma drainage device more than 3 months after it has been placed has any effect on intraocular pressure. Participation in research studies is voluntary.","whoItsFor":["Ages 18 Years to any","Placement of Ahmed Clear Path or Baervelt drainage device with ripcord \\> 3 months","Diagnosis of Glaucoma, under active management at Duke Eye Center Glaucoma Clinic","Ripcord suture still in place and accessible for removal"],"whoShouldSkip":["Active ocular infection or conjunctivitis in either eye","Inability to undergo ripcord removal procedure","Scheduled for further glaucoma surgery"],"whatHappens":"If you join, the listed intervention(s) are Ripcord removal. The registry lists allocation as na. This is a research study to find out if removing the ripcord from a glaucoma drainage device more than 3 months after it has been placed has any effect on intraocular pressure.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Durham. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.036Z"},{"nctId":"NCT07804615","title":"A Study to Evaluate the Efficacy, PK, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy","officialTitle":"A Phase 2 Study to Evaluate the Efficacy, Pharmacokinetics, Safety, and Tolerability of VIM0423 in Adults With Parkinson's Disease Tremor Insufficiently Responsive to Dopaminergic Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Vima Therapeutics","sponsorClass":"INDUSTRY","summary":"Vista PD is a randomized, placebo-controlled, multicenter study to evaluate the efficacy, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy.\n\nThe main objectives of this clinical trial are to determine the following:\n\n* Does VIM0423 therapy improve tremor symptoms in adults with Parkinson's disease?\n* Is VIM0423 well tolerated in individuals with Parkinsons's disease? and\n* Do the therapeutic effects of VIM0423 confer improvements on daily function and quality of life?","conditions":["PARKINSON DISEASE (Disorder)"],"keywords":["Parkinsonian Disorders","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Neurodegenerative Diseases","Parkinson Disease","Tremor","Movement Disorder"],"interventions":[{"type":"DRUG","name":"VIM0423"},{"type":"DRUG","name":"VIM0423 Placebo"}],"enrollment":80,"startDate":"2026-09-15","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening).\n* Diagnosis of clinically probable or clinically established idiopathic Parkinson's disease (PD) at Visit 1 (Screening) established by the MDS 2015 criteria which must include tremor as one of the cardinal characteristics.\n* Cohort 1: Currently using levodopa (any oral form only) or oral dopamine agonist at a stable dose and regimen of at least 10 weeks prior to Visit 1 (Screening); with no anticipated changes to said therapies for the duration of the study; and on a minimum of 300 mg LEDD. Cohort 2: Individuals who are dopaminergic naïve, as defined by: no prior or ongoing usage of levodopa (in any form) or dopamine agonist (in any form), and no anticipated plans to initiate said therapies for the duration of the study.\n* The participants must meet protocol-specified requirements for baseline tremor scores.\n\nExclusion Criteria\n\n* Currently (within 7 days of Screening) taking any anticholinergic medication.\n* Prior deep brain stimulation (DBS) or any other form of invasive neurosurgical intervention (including, but not limited to, magnetic resonance-guided focused ultrasound thalamotomy, ablative thalamotomy, gamma knife thalamotomy)\n\nOther protocol-specified inclusion and exclusion criteria may apply.","locations":[{"facility":"Vima Site #039","city":"Scottsdale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #064","city":"Scottsdale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #048","city":"Murrieta","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #050","city":"Stamford","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #065","city":"Altamonte Springs","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #054","city":"Aventura","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #008","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #046","city":"Naples","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #053","city":"Palm Beach","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #062","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #047","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #045","city":"Decatur","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #041","city":"Overland Park","state":"Kansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #043","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #007","city":"Olney","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #002","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #014","city":"Albuquerque","state":"New Mexico","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #055","city":"Amherst","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #024","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #052","city":"Patchogue","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #067","city":"Raleigh","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #051","city":"Canton","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #016","city":"Memphis","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #049","city":"Cypress","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #063","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #058","city":"Round Rock","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #066","city":"Arlington","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #023","city":"Kirkland","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #015","city":"Spokane","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vima Site #060","city":"Toronto","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"617-430-7027","email":"Clinicaltrials@vimatx.com"}],"primaryOutcomes":["Change from baseline in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","murrieta-california","stamford-connecticut","altamonte-springs-florida","aventura-florida","miami-florida","naples-florida","palm-beach-florida","tampa-florida","atlanta-georgia","decatur-georgia","overland-park-kansas","baltimore-maryland","olney-maryland","farmington-hills-michigan","albuquerque-new-mexico","amherst-new-york","new-york-new-york","patchogue-new-york","raleigh-north-carolina","canton-ohio","memphis-tennessee","cypress-texas","dallas-texas","round-rock-texas","arlington-virginia","kirkland-washington","spokane-washington","toronto-canada"],"enrichment":{"headline":"Phase 2: testing VIM0423 for PARKINSON DISEASE (Disorder)","inPlainEnglish":"Vista PD is a randomly assigned, compared with a dummy treatment, multicenter study to measure the how well it works, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy. The main objectives of this clinical trial are to determine the following: * Does VIM0423 therapy improve tremor symptoms in adults with Parkinson's disease?","whoItsFor":["Ages 18 Years to 65 Years","Participant must be male or nonpregnant female between 18 and 65 years of age (inclusive) at Visit 1 (Screening)","Diagnosis of clinically probable or clinically established idiopathic Parkinson's disease (PD) at Visit 1 (Screening) established by the MDS 2015 criteria which must include tremor as one of the cardinal characteristics","The participants must meet protocol-specified requirements for baseline tremor scores"],"whoShouldSkip":["Currently (within 7 days of Screening) taking any anticholinergic medication","Prior deep brain stimulation (DBS) or any other form of invasive neurosurgical intervention (including, but not limited to, magnetic resonance-guided focused ultrasound thalamotomy, ablative thalamotomy, gamma knife thalamotomy)","Other protocol-specified inclusion and"],"whatHappens":"If you join, the listed intervention(s) are VIM0423, or VIM0423 Placebo. The registry lists allocation as randomized. Vista PD is a randomly assigned, compared with a dummy treatment, multicenter study to measure the how well it works, PK, safety, and tolerability of VIM0423 in adults with Parkinson's disease tremor insufficiently responsive to dopaminergic therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 80 people at 30 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.659Z"},{"nctId":"NCT07805486","title":"Development of a Multimodal Deep Learning Model for Pediatric Patients","officialTitle":"Development of an Artificial Intelligence-Based Model for Assessing the Severity of Pediatric Obstructive Sleep Apnea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fu Jen Catholic University","sponsorClass":"OTHER","summary":"This study aims to develop a multimodal data-driven model integrating multiple noninvasive physiological signals to assess the severity of pediatric sleep-disordered breathing, using standard clinical sleep study results as the reference.","conditions":["Pediatric Obstructive Sleep Apnea","Polysomnography"],"keywords":["pediatric obstructive sleep apnea","polysomnography","smart mattress","millimeter-wave radar","multimodal deep learning"],"interventions":[{"type":"DEVICE","name":"fingertip pulse oximeter"},{"type":"DEVICE","name":"pressure-sensing mattresses"},{"type":"DEVICE","name":"millimeter-wave radar"}],"enrollment":50,"startDate":"2026-10-08","completionDate":"2027-07-31","sex":"ALL","minAge":"4 Years","maxAge":"18 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals with clinical suspicion of obstructive sleep apnea who are referred for polysomnography\n\nExclusion Criteria:\n\n* Intolerance to a fingertip or wrap-around pulse oximeter\n* Presence of significant structural abnormalities of the upper airway\n* Cardiac arrhythmia\n* Neuromuscular disease\n* Hospitalization within the previous one month","locations":[{"facility":"Fu Jen Catholic University Hospital, Fu Jen Catholic University","city":"New Taipei City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ke-Yun Chao, PhD","phone":"+886-905-301-879","email":"C00152@mail.fjuh.fju.edu.tw"}],"primaryOutcomes":["the correlation among the apnea-hypopnea index, millimeter-wave radar signals, and ballistocardiography waveforms"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["new-taipei-city-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: fingertip pulse oximeter for Pediatric Obstructive Sleep Apnea","inPlainEnglish":"This study aims to develop a multimodal data-driven model integrating multiple noninvasive physiological signals to assess the severity of pediatric sleep-disordered breathing, using standard clinical sleep study results as the reference.","whoItsFor":["Ages 4 Years to 18 Years","Individuals with clinical suspicion of obstructive sleep apnea who are referred for polysomnography"],"whoShouldSkip":["Intolerance to a fingertip or wrap-around pulse oximeter","Presence of significant structural abnormalities of the upper airway","Neuromuscular disease","Hospitalization within the previous one month"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at New Taipei City. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.943Z"},{"nctId":"NCT07805954","title":"Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma","officialTitle":"A Phase 3, Randomized, Open-Label Study of Zoldonrasib (RMC-9805) Plus Daraxonrasib (RMC-6236) Versus Gemcitabine and Nab-Paclitaxel as First-Line Treatment in Patients With Metastatic KRAS G12D-Mutated Pancreatic Adenocarcinoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Revolution Medicines, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.","conditions":["Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Pancreatic Adenosquamous Carcinoma"],"keywords":["Pancreatic Cancer","PDAC","Pancreatic Ductal Adenocarcinoma","RAS","KRAS","RAS Mutation","Pancreatic Cancer Metastatic","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenosquamous Carcinoma","Pancreatic Adenocarcinoma"],"interventions":[{"type":"DRUG","name":"daraxonrasib"},{"type":"DRUG","name":"gemcitabine"},{"type":"DRUG","name":"nab-paclitaxel"},{"type":"DRUG","name":"zoldonrasib"}],"enrollment":400,"startDate":"2026-08-28","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting.\n* No prior treatment in the locally advanced unresectable or metastatic setting\n* Diagnosis of metastatic disease ≤ 6 weeks prior to informed consent.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n\nExclusion Criteria:\n\n* Mutation status with known driver mutations for which there are approved targeted therapies.\n* Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies.\n* Tumors determined to originate from non-pancreatic primary sites.\n* Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting.\n* Active or known history of untreated central nervous system metastatic or leptomeningeal disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.\n* Additional inclusion \\& exclusion criteria may apply.","locations":[{"facility":"Mayo Clinic Arizona","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"HonorHealth Research Institute","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Florida","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic Rochester","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rhode Island Hospital","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Revolution Medicines Study Director","phone":"1-844-2-REVMED","email":"medinfo@revmed.com"}],"primaryOutcomes":["Progression free survival (PFS)","Overall survival (OS)"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["phoenix-arizona","scottsdale-arizona","jacksonville-florida","tampa-florida","rochester-minnesota","providence-rhode-island"],"enrichment":{"headline":"Phase 3: testing daraxonrasib for Pancreatic Cancer","inPlainEnglish":"This study wants to measure the how well it works of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Histologically or cytologically confirmed pancreatic adenocarcinoma, including adenosquamous carcinoma, not previously treated in the locally advanced unresectable or metastatic setting","No prior treatment in the locally advanced unresectable or metastatic setting","Documented KRAS G12D mutation status","Measurable disease per RECIST v1.1","Adequate organ function (bone marrow, liver, kidney, coagulation)"],"whoShouldSkip":["Mutation status with known driver mutations for which there are approved targeted therapies","Acinar cell carcinoma, pancreatic neuroendocrine tumors, tumors involving islet cells or islet cell neoplasms, and other non-adenocarcinoma pancreatic malignancies","Tumors determined to originate from non-pancreatic primary sites","Prior treatment with MAPK-pathway targeted therapy or administration of RAS-targeted vaccine in the metastatic setting","Active or known history of untreated central nervous system metastatic or leptomeningeal disease","Any conditions that may affect the ability to take or absorb study drug","Major surgery within 28 days prior to randomization"],"whatHappens":"If you join, the listed intervention(s) are daraxonrasib, gemcitabine, or nab-paclitaxel. The registry lists allocation as randomized. This study wants to measure the how well it works of combination therapy with two investigational RAS(ON) inhibitors (daraxonrasib and zoldonrasib) compared to chemotherapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.449Z"},{"nctId":"NCT07805980","title":"A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia","officialTitle":"The Study of Improving Antipsychotic-induced Appetite by Deep Transcranial Magnetic Stimulation: The Effects of Improving Antipsychotic-induced Appetite by Single Session dTMS After Food Cue-induced Craving, A Randomized, Crossover and Sham-Controlled Trail","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"Second Xiangya Hospital of Central South University","sponsorClass":"OTHER","summary":"Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics. There are no hitherto effective treatments for reducing antipsychotic-induced weight gain. dTMS which is a safe and non-invasive physical treatment indicates greater efficacy than other transcranial magnetic stimulation (TMS) by some research. Apart from that, symptom provocation is believed to improve the clinical responses to TMS. In this study, the investigators, firstly, evaluate the safety and effectiveness of dTMS for reducing antipsychotic-induced weight gain and secondly, unveil whether symptom provocation can affect the clinical responses to TMS.","conditions":["Schizophrenia","Antipsychotic Induced Weight Gain"],"keywords":["Schizophrenia","Antipsychotic induced weight gain","dTMS"],"interventions":[{"type":"DEVICE","name":"Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active"},{"type":"DEVICE","name":"Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham"}],"enrollment":30,"startDate":"2026-10-01","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged between 18-60\n* Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).\n* Gaining body weight around 7% after intaking antipsychotics within 2 years\n* Participants were on a stable medication regimen at the time of enrollment\n* Written informed consent was obtained from both the participants and their legally authorized guardians\n\nExclusion Criteria:\n\n* Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.\n* Diagnosed with other mental diseases in accordance with DSM-V\n* Comorbid with other severe physiological diseases\n* Active suicidal ideation\n* A history of alcohol or substance use disorder (or abuse)\n* Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)\n* Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation\n* Receipt of regular repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month\n* Pregnant or lactating women","locations":[{"facility":"The Second Xiangya Hospital of Central South University","city":"Changsha","state":"Hunan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ping Shao","phone":"+86-13755112445","email":"shp97jw@163.com"},{"name":"Renrong Wu","phone":"+86-15874179855","email":"wurenrong@csu.edu.cn"}],"primaryOutcomes":["Food Craving Questionnaire State, FCQ-S"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["changsha-china"],"enrichment":{"headline":"Not a traditional drug phase: Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active for Schizophrenia","inPlainEnglish":"Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia. Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics.","whoItsFor":["Ages 18 Years to 60 Years","Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)","Gaining body weight around 7% after intaking antipsychotics within 2 years","Participants were on a stable medication regimen at the time of enrollment"],"whoShouldSkip":["Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period","Diagnosed with other mental diseases in accordance with DSM-V","Comorbid with other severe physiological diseases","Active suicidal ideation","A history of alcohol or substance use disorder (or abuse)","Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)","Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation"],"whatHappens":"If you join, the listed intervention(s) are Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Active, or Deep Transcranial Magnetic Stimulation (dTMS) H4 coil - Sham. The registry lists allocation as randomized. Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Changsha. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.046Z"},{"nctId":"NCT07807475","title":"DNP-MRSI of HCC Metabolism to Predict Therapeutic Response","officialTitle":"Dynamic Nuclear Polarization-MR Spectroscopic Imaging of Hepatocellular Carcinoma Metabolism to Predict Response Following Locoregional or Systemic Therapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Abramson Cancer Center at Penn Medicine","sponsorClass":"OTHER","summary":"This proposal describes a non-therapeutic diagnostic clinical trial to estimate the ability of DNP-MRS imaging of hyperpolarized 1-13C-pyruvate uptake and metabolism to predict response following LRT with TACE/TARE/Microwave Ablation or ST in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B or C HCC. The primary hypothesis is that intratumoral pyruvate, lactate, alanine and carbon dioxide/bicarbonate measured by DNP-MRSI correspond to cellular viability resulting from recurrent or progressive HCC following LRT or ST. The secondary hypothesis is that lactate-to-alanine ratios measured by DNP-MRSI can distinguish well- vs. poorly perfused tumor regions as identified on contrast-enhanced MR imaging.","conditions":["Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC","Hepatocellular Carcinoma (HCC)"],"keywords":["HCC"],"interventions":[{"type":"DRUG","name":"Hyperpolarized 1-13C -Pyruvate"}],"enrollment":232,"startDate":"2026-09-17","completionDate":"2031-09-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female, aged ≥ 18 years\n2. At least one HCC tumor meeting criteria for diagnosis of BCLC A, B or C HCC based on cross-sectional imaging as determined by a board-certified, sub-specialty trained radiologist\n3. Baseline systolic blood pressure \\>90 mmHg or \\<180 mmHg\n4. Signed and dated informed consent form\n5. Willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast feeding at the time of screening will not be eligible for this study. Females who are breast feeding are excluded because breast feeding is not recommended during the therapies which are included in the inclusion criteria for this study. For females with childbearing potential, a serum or urine pregnancy test will be performed within 1 day prior to the injection of \\[1-13C\\]-pyruvate in women of child-bearing potential. A lack of childbearing potential is defined as A) ≥50 years old, without menstrual activity for \\>12 consecutive months, or B) Surgical sterilizations other than only tubal ligation. Females who do not meet the criteria defined in A, but have had tubal ligation, must still undergo pregnancy testing. Patient self-reporting the use of contraception, abstinence or same-sex partnership does not replace the need for pregnancy testing in women of childbearing potential\n2. Prior LRT or systemic cancer therapy to the target lesion\n3. Contraindication to MRI including prior MRI contrast reaction\n4. Metallic implant within the liver\n5. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician including but not limited to the inability to lie still in the magnet for 1 hour and/or cooperate with breath holding instructions\n6. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study\n7. Baseline systolic blood pressure \\<90 mmHg or \\>180 mmHg, or symptomatic orthostatic hypotension, measured within 1 hour prior to injection of hyperpolarized 1-13C-pyruvate\n8. Congestive heart failure with New York Heart Association (NYHA) status ≥2\n9. A history of clinically significant EKG abnormalities, including QT prolongation, a family history of prolonged QT interval syndrome, or myocardial infarction (MI) within 6 months of study entry\n10. Decompensated cirrhosis (Child-Pugh C)\n11. Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2 within 28 days prior to contrast-enhanced MRI, unless patient is already on chronic dialysis\n12. Current use of high-dose beta-adrenergic antagonists (e.g., propranolol \\> 160 mg/day, metoprolol \\>200 mg/day, as these medications may impair compensatory tachycardia in response to pyruvate-induced vasodilation","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Terence Gade, MD, PhD","phone":"2155739756","email":"TGade@pennmedicine.upenn.edu"},{"name":"Jelsia Cottone","phone":"2157466788","email":"jelsia.cottone@pennmedicine.upenn.edu"}],"primaryOutcomes":["Primary Objective:"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Not a traditional drug phase: testing Hyperpolarized 1-13C -Pyruvate for Barcelona Clinic Liver Cancer (BCLC) Stage A, B or C HCC","inPlainEnglish":"This proposal describes a non-therapeutic diagnostic clinical trial to estimate the ability of DNP-MRS imaging of hyperpolarized 1-13C-pyruvate uptake and metabolism to predict response following LRT with TACE/TARE/Microwave Ablation or ST in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B or C HCC. The primary hypothesis is that intratumoral pyruvate, lactate, alanine and carbon dioxide/bicarbonate measured by DNP-MRSI correspond to cellular viability resulting from recurrent or progressive HCC following LRT or ST.","whoItsFor":["Ages 18 Years to any","Male or female, aged ≥ 18 years","At least one HCC tumor meeting criteria for diagnosis of BCLC A, B or C HCC based on cross-sectional imaging as determined by a board-certified, sub-specialty trained radiologist","Baseline systolic blood pressure \\>90 mmHg or \\<180 mmHg","Willingness to comply with all study procedures and availability for the duration of the study"],"whoShouldSkip":["Prior LRT or systemic cancer therapy to the target lesion","Contraindication to MRI including prior MRI contrast reaction","Metallic implant within the liver","Inability to tolerate imaging procedures in the opinion of an investigator or treating physician including but not limited to the inability to lie still in the magnet for 1 hour and/or cooperate with breath holding instructions","Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study","Baseline systolic blood pressure \\<90 mmHg or \\>180 mmHg, or symptomatic orthostatic hypotension, measured within 1 hour prior to injection of hyperpolarized 1-13C-pyruvate","Congestive heart failure with New York Heart Association (NYHA) status ≥2"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 232 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.627Z"},{"nctId":"NCT07807865","title":"A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)","officialTitle":"An Open-label, Multicenter Trial to Assess the Long-term Safety and Tolerability of ITI 1284 as Either Adjunctive or Monotherapy Treatment in Patients With Generalized Anxiety Disorder (GAD) With a History of Inadequate Response to GAD Treatment","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.","conditions":["Generalized Anxiety Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"ITI-1284"}],"enrollment":900,"startDate":"2026-09-03","completionDate":"2030-02-18","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria for Roll-over participants:\n\n* Provide written informed consent before the initiation of any study specific procedures\n* Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study\n* Male or female of childbearing potential and agrees to use a highly effective method of birth control from the time informed consent is provided until 30 days after the last dose of ITI-1284 for females and 90 days after the last dose of ITI-1284 for males\n* Ability to follow study instructions and likely to complete all required visits\n* In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)\n* If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study\n\nInclusion criteria for De-novo participants:\n\n* Provide written informed consent before the initiation of any study-specific procedures\n* Male or female participants greater than or equal to (\\>=) 18 years of age\n* Has a body mass index (BMI) of 19-40 kilogram per meter squared (kg/m\\^2), inclusive\n* At screening, meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (DSM-5-TR) diagnostic criteria for moderate or severe generalized anxiety disorder (GAD) (current GAD) as confirmed by the investigator or sponsor-approved rater using the structured clinical interview for DSM-5, clinical trials version (SCID 5-CT)\n* Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study\n\nExclusion criteria for Roll-over participants\n\n* In the opinion of the Investigator, the participant has a significant risk for suicidal behavior during the course of her/his participation in the study or is considered to be an imminent danger to her/himself or others, and/or: a. At baseline, the participant scores \"yes\" on suicidal Ideation Items 4 or 5 of the Columbia-suicide severity rating scale (C-SSRS) \"Since Last Visit\" version; b. At baseline, the participant scores \\>= 5 on the Montgomery-Asberg depression rating scale (MADRS) Item 10 (suicidal Thoughts); c. The participant is considered to be an imminent danger to themself or others based on the assessment of the Investigator\n* The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline\n* Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study\n* The participant has any other condition that may be detrimental to the participant if they participate in the study\n* In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study\n\nExclusion criteria for De-novo participants\n\n* Within the participant's lifetime, has one of the following confirmed DSM-5-TR psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder\n* Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders; b. moderate or severe alcohol or substance use disorders; c. moderate or severe major depressive disorder (MDD)\n* MADRS total score greater than (\\>) 18 at screening or baseline\n* The participant has received electroconvulsive therapy (ECT) or vagal nerve stimulation within the past 5 years, or repetitive trans cranial magnetic stimulation within the last 2 years, or had a failure in response to ECT at any time\n* The participant has known hypersensitivity or intolerance to ITI-007 (lumateperone), ITI-1284, or to any of the excipients","locations":[{"facility":"CalNeuro Research","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sunshine Medical Research Studies Inc","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SPRI Clinical Trials, LLC","city":"Brooklyn","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Number of Participants with Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["los-angeles-california","miami-florida","brooklyn-new-york"],"enrichment":{"headline":"Phase 3: testing ITI-1284 for Generalized Anxiety Disorder","inPlainEnglish":"This study wants to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously. GAD is a mental health condition defined by constant, uncontrollable worry about everyday things that lasts for six months or more.","whoItsFor":["Ages 18 Years to any","for Roll-over participants:","Is currently an outpatient, and is anticipated to maintain outpatient status for the duration of the study","Ability to follow study instructions and likely to complete all required visits","In the opinion of the Investigator, the patient must have safely completed the lead-in study (ITI-1284-301 or ITI-1284-302)","If entering from lead-in study ITI-1284-301, must be expected to continue their ongoing anti-depressant therapy (ADT) or buspirone from the lead-in study","who can join for De-novo participants:","Male or female participants greater than or equal to (\\>=) 18 years of age"],"whoShouldSkip":["for Roll-over participants","The participant is breast-feeding or pregnant; female participants of childbearing potential must have a negative urine pregnancy test at baseline","Based on the Investigator's clinical judgement, any abnormal clinical laboratory test or electrocardiogram (ECG) results obtained throughout the lead-in study that are considered clinically significant and preclude safe participation in the study","The participant has any other condition that may be detrimental to the participant if they participate in the study","In the opinion of the Investigator, the participant is unable to comply with study procedures or judged to be inappropriate for the study"],"whatHappens":"If you join, the listed intervention(s) are ITI-1284. The registry lists allocation as na. This study wants to assess how safe ITI-1284 is and how well it can be tolerated in long-term, when given alone or with other medicines, in participants with generalized anxiety disorder (GAD) who have not responded to treatment previously.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 900 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.346Z"},{"nctId":"NCT07808164","title":"ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort","officialTitle":"ENPP1/cGAS (EG) and FAP Expression Profiles in Solid Tumors: An Immunohistochemical Study in a Vietnamese Cohort","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Tam Anh Research Institute","sponsorClass":"OTHER","summary":"This Vietnam-based observational study examines ecto-nucleotide pyrophosphatase/phosphodiesterase 1/cyclic GMP-AMP synthase (ENPP1/cGAS) protein and stromal fibroblast activation protein (FAP) expression in multiple solid tumor samples using immunohistochemistry (IHC). The study involves no investigational treatments or participant-facing procedures. Tumor samples used in this study consist exclusively of archived formalin-fixed paraffin- embedded (FFPE) tumor samples that were collected as part of routine clinical diagnosis or treatment and for which all required procedures for standard clinical care have been completed. Only archived tumor samples obtained from routine clinical care will be included in this study. No additional biopsy, surgical resection, or specimen collection will be performed for research purposes, and no sample will be diverted prior to completion of clinical requirements. All included archived tumor samples will undergo ENPP1, cGAS, and FAP IHC analysis according to the procedures specified in the Laboratory Manual.","conditions":["HCC - Hepatocellular Carcinoma","CRC (Colorectal Cancer)","Gastric Carcinoma","Breast Cancer","Lung Cancer","Endometrial Cancer","Melanoma (Skin Cancer)","Pancreatic Cancer"],"keywords":["cancer","IHC","ENPP1/cGAS (EG)","FAP","Vietnam","Tam Anh TP. Ho Chi Minh Hospital","Tam Anh General Hospital","observation","Immunohistochemical Study"],"interventions":[{"type":"OTHER","name":"IHC analysis for ENPP1, cGAS, and FAP expression"}],"enrollment":162,"startDate":"2026-03-19","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis: Patients with a histopathologically or cytologically confirmed diagnosis of malignant solid tumors, including but not limited to colorectal cancer (CRC), hepatocellular carcinoma (HCC), lung cancer, melanoma, pancreatic cancer,breast cancer, or other solid tumors relevant to the study objectives.\n* Age: Vietnamese patients aged ≥ 18 years at the time of tumor tissue collection.\n* Availability and quality of biospecimens:\n\n  1. Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens collected within 24 months prior to specimen eligibility verification and currently stored at the study site.\n  2. Tumor tissue specimens confirmed by a study pathologist to contain an adequate proportion of viable tumor cells (minimum of 1500 tumor cells per section) and sufficient material for analysis (at least one FFPE block or four unstained slides, 3-5 um in thickness).\n  3. Only archived residual tissue specimens remaining after completion of all routine clinical diagnostic and/or therapeutic purposes will be used for study purposes.\n* Availability of clinical data: Patient medical records must contain essential baseline information required for the study, including at minimum basic demographic data (age, sex) and histopathological diagnosis.\n* Ethical considerations: The study will be conducted using tissue specimens classified as archived samples at the time of eligibility assessment and is eligible for a waiver of informed consent in accordance with the requirements and approval of the Local Ethics Committee/Institutional Review Board (LEC/IRB).\n\nExclusion Criteria:\n\n* Discordance between clinical diagnosis and tissue histopathology: The diagnosis documented in the medical record is inconsistent with the histopathological findings of the tissue specimen intended for study use.\n* Legal or policy restrictions: Patients or their legally authorized representatives have declined the use of tissue specimens for secondary research purposes, or the specimens are not permitted for research use under institutional policies or decisions of the LEC/IRB.","locations":[{"facility":"Tam Anh General Hospital","city":"Hanoi","state":"Hanoi","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tam Anh TP. Ho Chi Minh Hospital","city":"Ho Chi Minh City","state":"Ho Chi Minh","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Prevalence of EG+ phenotype (ENPP1/cGAS co-expression) and stromal FAP expression"],"hasResults":false,"conditionSlugs":["breast-cancer","lung-cancer","colorectal-cancer","pancreatic-cancer","melanoma","liver-cancer","endometrial-cancer","hiv"],"drugSlugs":[],"locationSlugs":["hanoi-vietnam","ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: IHC analysis for ENPP1, cGAS, and FAP expression for HCC - Hepatocellular Carcinoma","inPlainEnglish":"This Vietnam-based watch-and-measure (no experimental treatment required) study examines ecto-nucleotide pyrophosphatase/phosphodiesterase 1/cyclic GMP-AMP synthase (ENPP1/cGAS) protein and stromal fibroblast activation protein (FAP) expression in multiple solid tumor samples using immunohistochemistry (IHC). The study involves no investigational treatments or participant-facing procedures.","whoItsFor":["Ages 18 Years to any","Age: Vietnamese patients aged ≥ 18 years at the time of tumor tissue collection","Availability and quality of biospecimens:","Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens collected within 24 months prior to specimen eligibility verification and currently stored at the study site","Tumor tissue specimens confirmed by a study pathologist to contain an adequate proportion of viable tumor cells (minimum of 1500 tumor cells per section) and sufficient material for analysis (at least one FFPE block or four unstained slides, 3-5 um in thickness)","Only archived residual tissue specimens remaining after completion of all routine clinical diagnostic and/or therapeutic purposes will be used for study purposes","Availability of clinical data: Patient medical records must contain essential baseline information required for the study, including at minimum basic demographic data (age, sex) and histopathological diagnosis"],"whoShouldSkip":["Discordance between clinical diagnosis and tissue histopathology: The diagnosis documented in the medical record is inconsistent with the histopathological findings of the tissue specimen intended for study use","Legal or policy restrictions: Patients or their legally authorized representatives have declined the use of tissue specimens for secondary research purposes, or the specimens are not permitted for research use under institutional policies or decisions of the LEC/IRB"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 162 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.634Z"},{"nctId":"NCT07809503","title":"Multimodal Ocular Diagnosis-Guided Precision Acupuncture and Lifestyle Intervention for PCOS","officialTitle":"MulticenterClinical Study of Intelligent and Precise Acupuncture and Lifestyle Interventions for Polycystic Ovary Syndrome Guided by Multimodal With Ocular Diagnosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Peking University Third Hospital","sponsorClass":"OTHER","summary":"This study is designed as a prospective, multicenter, parallel-group randomized controlled trial to evaluate the effectiveness of a \"precision acupuncture + personalized lifestyle\" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS). Compared with \"conventional acupuncture + standard lifestyle intervention,\" the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment. The safety of the intervention, improvements in endocrine and metabolic profiles, menstrual and ovulatory outcomes, psychological status, quality of life, and health-economic outcomes will also be evaluated. The study aims to provide evidence for establishing an intelligent and individualized clinical management model for PCOS.","conditions":["Polycystic Ovary Syndrome"],"keywords":[],"interventions":[{"type":"OTHER","name":"Model-Guided Precision Acupuncture"},{"type":"BEHAVIORAL","name":"Personalized Lifestyle Intervention"},{"type":"OTHER","name":"Conventional Acupuncture"},{"type":"BEHAVIORAL","name":"Standard Lifestyle Intervention"}],"enrollment":210,"startDate":"2026-07-10","completionDate":"2028-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged18-40 years, inclusive.\n* Body mass index (BMI) of 25-40 kg/m², inclusive.\n* Meeting the 2003 Rotterdam diagnostic criteria for polycystic ovary syndrome (PCOS), defined by the presence of at least two of the following three criteria: Oligo-ovulation or anovulation; Clinical and/or biochemical signs of hyperandrogenism; Polycystic ovarian morphology on ultrasonography.\n* Willing to participate voluntarily in the study, able to understand the study procedures, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of hyperandrogenemia due to other causes, such as hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, or exogenous androgen use.\n* Presence of renal disease (creatinine clearance \\<60 mL/min), hepatic impairment, autoimmune disease, or malignancy.\n* Type 1 diabetes mellitus or glycated hemoglobin (HbA1c) \\>53 mmol/mol (7%). - Use, within the past 3 months, of medications that may affect study assessments, including glucocorticoids, insulin, glucose-lowering agents such as acarbose, antidepressants, hormonal contraceptives, ovulation-inducing agents, or other relevant medications.\n* Blood pressure \\>160/100 mmHg.\n* Currently pregnant or breastfeeding, pregnancy within the past 6 months, or planning to become pregnant during the study period.\n* Having received continuous acupuncture treatment for at least 2 months prior to study treatment.\n* Daily smoking or alcohol consumption.\n* Presence of language barriers, psychiatric disorders, or other conditions that may impair the participant's ability to understand the study, comply with the intervention, or complete follow-up assessments.","locations":[{"facility":"Beijing Haidian Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University Third Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Haolin Zhang, PhD","phone":"+86 15611963539","email":"zoe@bjmu.edu.cn"}],"primaryOutcomes":["HOMA-IR level after 12 weeks of treatment"],"hasResults":false,"conditionSlugs":["als","pcos"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Model-Guided Precision Acupuncture for Polycystic Ovary Syndrome","inPlainEnglish":"This study is designed as a prospective, multicenter, parallel-group randomly assigned controlled trial to measure the effectiveness of a \"precision acupuncture + personalized lifestyle\" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS). Compared with \"conventional acupuncture + standard lifestyle intervention,\" the study will primarily assess changes in the homeostatic model assessment of insulin resistance (HOMA-IR) after 12 weeks of treatment.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Aged18-40 years, inclusive","Body mass index (body-mass index (BMI)) of 25-40 kg/m², inclusive"],"whoShouldSkip":["Presence of hyperandrogenemia due to other causes, such as hyperprolactinemia, thyroid disorders, congenital adrenal hyperplasia, or exogenous androgen use","Presence of renal disease (creatinine clearance \\<60 mL/min), hepatic impairment, autoimmune disease, or malignancy","Blood pressure \\>160/100 mmHg","Currently pregnant or breastfeeding, pregnancy within the past 6 months, or planning to become pregnant during the study period","Having received continuous acupuncture treatment for at least 2 months prior to study treatment","Daily smoking or alcohol consumption","Presence of language barriers, psychiatric disorders, or other conditions that may impair the participant's ability to understand the study, comply with the intervention, or complete follow-up assessments"],"whatHappens":"If you join, the listed intervention(s) are Model-Guided Precision Acupuncture, Personalized Lifestyle Intervention, or Conventional Acupuncture. The registry lists allocation as randomized. This study is designed as a prospective, multicenter, parallel-group randomly assigned controlled trial to measure the effectiveness of a \"precision acupuncture + personalized lifestyle\" intervention, guided by dynamic multimodal risk monitoring based on the four diagnostic methods of Traditional Chinese Medicine (TCM), in improving insulin resistance in patients with polycystic ovary syndrome (PCOS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 210 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.790Z"},{"nctId":"NCT07810218","title":"Personalized Exercise Recommendations for Chronic Pelvic Pain Using Reinforcement Learning","officialTitle":"WorkoutCPP: A Pilot Series of N-of-1 Trials Evaluating RL-Generated Adaptive Exercise Recommendations for Pelvic Pain Management","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs). The study uses reinforcement learning (RL), a type of artificial intelligence that adapts recommendations over time based on each participant's reported pain levels, symptom burden, and exercise compliance. Participants receive daily exercise recommendations that alternate between standard, non-personalized guidance and personalized, RL-generated recommendations across four 2-week phases, allowing within-person comparison of outcomes under each condition. The primary hypothesis is that an RL-based adaptive recommendation system is feasible to deliver in a CPPD population.","conditions":["Pelvic Pain","Endometriosis","Chronic Pelvic Pain"],"keywords":["Mobile health","Reinforcement learning","Physical activity","N-of-1 trial","exercise","personalized","intervention"],"interventions":[{"type":"BEHAVIORAL","name":"Reinforcement Learning (RL)-Based Personalized Exercise Recommendations"},{"type":"BEHAVIORAL","name":"Generic Exercise Recommendation"}],"enrollment":45,"startDate":"2026-02-06","completionDate":"2027-08","sex":"FEMALE","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Self-reported CPPD (e.g., endometriosis, adenomyosis, fibroids, etc.) based on clinician diagnosis\n* Aged 18-55 years.\n* Ownership of an iOS or Android smartphone.\n* Willingness to self-track daily symptoms, exercise activities, and self-management behaviors using a smartphone research app.\n* Willingness to wear an activity tracker for the study duration.\n* Willingness to follow exercise recommendations from a smartphone research app, provided no adverse symptoms occur.\n* Ability to read and write in English sufficient to understand study materials and communications.\n* At least intermittently physically active (e.g., ≥30 minutes of walking twice per week).\n\nExclusion criteria:\n\n* Absolute contraindications to PA (e.g., recent myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, or uncontrolled severe hypertension, BP ≥180/110 mm Hg).\n* More than two \"Yes\" responses on the Physical Activity Readiness Questionnaire (PAR-Q) (16) without physician clearance.\n* Major life events expected during the next 10 weeks (e.g., pregnancy, planned surgery, or extended travel likely to interfere with participation).\n* Current or planned pregnancy within the next 6 months.\n* Having given birth in the past 6 months or currently nursing.\n* Inability to wear an activity tracker or use the app for the study duration.\n* Complete inactivity (i.e., \\<60 minutes of moderate-intensity PA per week).","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ipek Ensari, PhD","phone":"631-565-1829","email":"ipek.ensari@mssm.edu"},{"name":"Gerard M Ona, MD","phone":"347-835-8115","email":"GerardAnneAprilOna@mssm.edu"}],"primaryOutcomes":["Exercise Recommendation Adherence Rate","Participant Retention Rate"],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Reinforcement Learning (RL)-Based Personalized Exercise Recommendations for Pelvic Pain","inPlainEnglish":"WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs). The study uses reinforcement learning (RL), a type of artificial intelligence that adapts recommendations over time based on each participant's reported pain levels, symptom burden, and exercise compliance.","whoItsFor":["Ages 18 Years to 55 Years","Women only","Self-reported CPPD (e.g., endometriosis, adenomyosis, fibroids, etc.) based on clinician diagnosis","Ownership of an iOS or Android smartphone","Willingness to self-track daily symptoms, exercise activities, and self-management behaviors using a smartphone research app","Willingness to wear an activity tracker for the study duration","Willingness to follow exercise recommendations from a smartphone research app, provided no adverse symptoms occur","Ability to read and write in English sufficient to understand study materials and communications","At least intermittently physically active (e.g., ≥30 minutes of walking twice per week)"],"whoShouldSkip":["Absolute contraindications to PA (e.g., recent myocardial infarction, complete heart block, acute congestive heart failure, unstable angina, or uncontrolled severe hypertension, BP ≥180/110 mm Hg)","More than two \"Yes\" responses on the Physical Activity Readiness Questionnaire (PAR-Q) (16) without physician clearance","Major life events expected during the next 10 weeks (e.g., pregnancy, planned surgery, or extended travel likely to interfere with participation)","Current or planned pregnancy within the next 6 months","Having given birth in the past 6 months or currently nursing","Inability to wear an activity tracker or use the app for the study duration","Complete inactivity (i.e., \\<60 minutes of moderate-intensity PA per week)"],"whatHappens":"If you join, the listed intervention(s) are Reinforcement Learning (RL)-Based Personalized Exercise Recommendations, or Generic Exercise Recommendation. The registry lists allocation as randomized. WorkoutCPP is a pilot study evaluating the feasibility of a personalized exercise recommendation system for individuals with chronic pelvic pain disorders (CPPDs).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at New York. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.115Z"},{"nctId":"NCT07810777","title":"PRA-216 Atopic Dermatitis Safety and Efficacy Study","officialTitle":"A Phase 2 Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of PRA-216 in Participants With Moderate to Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Prana Therapies Inc","sponsorClass":"INDUSTRY","summary":"This study will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to placebo in patients with moderate to severe Atopic Dermatitis (AD)","conditions":["Atopic Dermatitis (AD)"],"keywords":["Inflammatory response","pharmacokinetics","pharmacodynamics","immunogenicity"],"interventions":[{"type":"DRUG","name":"Active PRA-216"},{"type":"DRUG","name":"Placebo"}],"enrollment":39,"startDate":"2026-09-17","completionDate":"2027-09-30","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Must be in good health with no significant medical history\n* Willing and able to attend all study visits, comply with study requirements.\n* Able and willing to provide written informed consent\n* Documented AD diagnosis prior to enrollment.\n* History of inadequate response to topical medications for AD\n\nExclusion Criteria:\n\n* Evidence of clinically significant skin condition or disease other than AD\n* Any physical or psychological condition that prohibits study completion\n* Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent\n* History of severe allergic reactions or hypersensitivity\n* Receipt of antibody therapy within 4 months or 5 half-lives\n* Other investigational agent(s) within 30 days or 5 half-lives","locations":[{"facility":"Emeritus Sydney","city":"Botany","state":"New South Wales","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aperio Clinical Research","city":"Liverpool","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cornerstone Centre for Clinical Research","city":"Coorparoo","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emeritus Melbourne","city":"Camberwell","state":"Victoria","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Momentum Sunshine","city":"Melbourne","state":"Victoria","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Optimal Clinical Trials (North)","city":"Auckland","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aotearoa Clinical Trials","city":"Auckland","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Momentum Christchurch","city":"Christchurch","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials New Zealand","city":"Hamilton","state":"","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Incidence, nature, and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["botany-australia","liverpool-australia","coorparoo-australia","camberwell-australia","melbourne-australia","auckland-new-zealand","christchurch-new-zealand","hamilton-new-zealand"],"enrichment":{"headline":"Phase 2: testing Active PRA-216 for Atopic Dermatitis (AD)","inPlainEnglish":"This study will measure the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to dummy treatment (placebo) in patients with moderate to severe Atopic Dermatitis (AD)","whoItsFor":["Ages 18 Years to 70 Years","Must be in good health with no significant medical history","Willing and able to attend all study visits, comply with study requirements","Documented AD diagnosis prior to enrollment","History of inadequate response to topical medications for AD"],"whoShouldSkip":["Evidence of clinically significant skin condition or disease other than AD","Any physical or psychological condition that prohibits study completion","Known history of illicit drug use or alcoholism within 12 months prior to the first dose of study agent","History of severe allergic reactions or hypersensitivity","Receipt of antibody therapy within 4 months or 5 half-lives","Other investigational agent(s) within 30 days or 5 half-lives"],"whatHappens":"If you join, the listed intervention(s) are Active PRA-216, or Placebo. The registry lists allocation as randomized. This study will measure the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 compared to dummy treatment (placebo) in patients with moderate to severe Atopic Dermatitis (AD)","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 39 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.832Z"},{"nctId":"NCT07810920","title":"Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine","officialTitle":"Innovation for Women's Health: the Integration of Artificial Intelligence in the Diagnostic Ultrasound Assessment of Reproductive Medicine","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Semmelweis University","sponsorClass":"OTHER","summary":"The goal of this observational study is to develop and validate artificial intelligence (AI)-based algorithms that support ultrasound diagnosis of endometriosis, adenomyosis, myometrial masses, uterine malformations, and impaired endometrial receptivity in women aged 18-45 years. The main questions it aims to answer are:\n\nCan AI algorithms, applied to standardized transvaginal ultrasound images, accurately detect and classify endometriosis and adenomyosis in real time during routine examination? Can AI-based ultrasound assessment predict the histological dignity of myometrial masses, and the likelihood of successful assisted reproduction (AR/IVF) outcome from endometrial features?\n\nParticipants attending the Department of Obstetrics and Gynecology, Semmelweis University, with clinical suspicion of endometriosis or adenomyosis, a confirmed myometrial mass scheduled for surgery, a suspected uterine anomaly, or scheduled IVF treatment, will undergo standardized transvaginal ultrasound examination (following the IDEA, MUSA, and IETA protocols) alongside collection of clinical, questionnaire, and, where surgery is performed, histopathological data. Imaging and clinical data will be used to build a database supporting the development and validation of the AI algorithms.","conditions":["Endometriosis","Adenomyosis of Uterus","Leiomyoma (Uterine Fibroids)","Uterine Neoplasms","Congenital Abnormalities","Infertility, Female"],"keywords":["reproductive medicine","artificial intelligence","deep learning","endometriosis","endometrial receptivity","adenomyosis","uterine leiomyoma"],"interventions":[],"enrollment":1600,"startDate":"2026-09-01","completionDate":"2030-05-31","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women aged 18-45 years with clinical suspicion of endometriosis or adenomyosis, in whom the diagnosis of endometriosis is subsequently confirmed, including peritoneal, ovarian, and deep infiltrating endometriosis. The diagnosis is established by imaging, laparoscopy, or laparotomy, based on characteristic intraoperative findings and histological analysis (#Enzian classification).\n* Women undergoing ultrasound examination for suspected congenital uterine anomaly or other intracavitary uterine pathology.\n* Women with previously confirmed leiomyoma scheduled for surgical treatment.\n* Women scheduled for IVF treatment or embryo transfer.\n* Willingness and capacity to provide written informed consent prior to enrolment.\n\nExclusion Criteria:\n\n* TVUS is not technically feasible.\n* Postmenopausal status.\n* Pregnancy.\n* Puerperium (up to 3 months postpartum).\n* Suspected premalignancy, or presence or history of malignancy.\n* Chronic comorbidities, including uncontrolled diabetes mellitus, severe cardiovascular or respiratory disease, systemic autoimmune disease, or uncontrolled thyroid dysfunction.\n* Other conditions, including psychiatric illness or substance use, and any circumstance in which study participation could pose a risk to the patient, or in which enrolment could bias the study results.\n* For the endometrial receptivity sub-study, confirmed uterine or endometrial pathology other than adenomyosis.","locations":[{"facility":"Department of Obstetrics and Gynecology, Semmelweis University","city":"Budapest","state":"Budapest","country":"Hungary","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nandor Acs, PhD","phone":"+3620825001","email":"acs.nandor@semmelweis.hu"}],"primaryOutcomes":["Diagnostic accuracy of the AI algorithm for detection of endometriosis and adenomyosis on transvaginal ultrasound"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["budapest-hungary"],"enrichment":{"headline":"Artificial Intelligence Into Ultrasound Diagnostics in Reproductive Medicine","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to develop and validate artificial intelligence (AI)-based algorithms that support ultrasound diagnosis of endometriosis, adenomyosis, myometrial masses, uterine malformations, and impaired endometrial receptivity in women aged 18-45 years. The main questions it aims to answer are: Can AI algorithms, applied to standardized transvaginal ultrasound images, accurately detect and classify endometriosis and adenomyosis in real time during routine examination?","whoItsFor":["Ages 18 Years to 45 Years","Women only","Women undergoing ultrasound examination for suspected congenital uterine anomaly or other intracavitary uterine pathology","Women with previously confirmed leiomyoma scheduled for surgical treatment","Women scheduled for IVF treatment or embryo transfer"],"whoShouldSkip":["TVUS is not technically feasible","Postmenopausal status","Puerperium (up to 3 months postpartum)","Suspected premalignancy, or presence or history of malignancy","Chronic comorbidities, including uncontrolled diabetes mellitus, severe cardiovascular or respiratory disease, systemic autoimmune disease, or uncontrolled thyroid dysfunction","Other conditions, including psychiatric illness or substance use, and any circumstance in which study participation could pose a risk to the patient, or in which enrolment could bias the study results","For the endometrial receptivity sub-study, confirmed uterine or endometrial pathology other than adenomyosis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,600 people at Budapest. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.114Z"},{"nctId":"NCT07815990","title":"Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking","officialTitle":"The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Suleyman Demirel University","sponsorClass":"OTHER","summary":"The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS.\n\nResearch hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.\n\nH2: In sensory dual-task tests involving proprioceptive and vestibular manipulations (BOSU ball, soft surface, and head movements synchronized with a metronome), MS patients with high aerobic fitness demonstrate better performance than the group with low aerobic fitness.\n\nH3: MS patients with high aerobic fitness report higher levels of balance confidence compared to the group with low aerobic fitness.\n\nH4: Perceived fatigue is greater in MS patients with low aerobic fitness compared to the group with high aerobic fitness.\n\nH5: There is a significant relationship between aerobic capacity levels and sensory dual-task performance, balance confidence, and fatigue severity in MS patients.","conditions":["Multiple Sclerosis"],"keywords":["Multiple Sclerosis","Aerobic Capacity","Dual-Task Performance","Postural Control","Dynamic Balance"],"interventions":[],"enrollment":70,"startDate":"2026-09-15","completionDate":"2027-01-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Having been diagnosed with Relapsing-Remitting or Progressive MS.\n* Being between 18-65 years of age.\n* Having an Expanded Disability Status Scale score between 1.5-5.\n* Being able to walk independently or with a unilateral assistive device.\n* Having full cooperation and orientation, and a cognitive level to understand given commands: Mini Mental Test score of 24 or higher.\n\nExclusion Criteria:\n\n* Having experienced an MS relapse or received acute corticosteroid treatment within the last 3 months.\n* Having an additional neurological, orthopedic, or rheumatological condition unrelated to MS that may affect balance and walking.\n* Having severe cardiovascular or respiratory disease that may make aerobic fitness assessment risky.\n* Having significant vision or hearing loss that would impede understanding test instructions.\n* Experiencing significant pain during measurements.\n* Having cognitive impairment that would prevent understanding or answering questions - scoring below 24 on the Minimental Test.","locations":[{"facility":"Süleyman Demirel Üniversitesi Araştırma ve Uygulama Hastanesi","city":"Isparta","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"ALEYNA OZDAMAR YUCEL, MSc","phone":"+90 507 950 74 57","email":"aleynayucel@sdu.edu.tr"},{"name":"MEHMET DURAY, associate professor","phone":"+90 506 473 11 65","email":"mehmetduray@sdu.edu.tr"}],"primaryOutcomes":["6-Minute Walk Test"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["isparta-turkey-t-rkiye"],"enrichment":{"headline":"Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking","inPlainEnglish":"The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS. Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.","whoItsFor":["Ages 18 Years to 65 Years","Having been diagnosed with Relapsing-Remitting or Progressive MS","Being between 18-65 years of age","Having an Expanded Disability Status Scale score between 1.5-5","Being able to walk independently or with a unilateral assistive device","Having full cooperation and orientation, and a cognitive level to understand given commands: Mini Mental Test score of 24 or higher"],"whoShouldSkip":["Having experienced an MS relapse or received acute corticosteroid treatment within the last 3 months","Having an additional neurological, orthopedic, or rheumatological condition unrelated to MS that may affect balance and walking","Having severe cardiovascular or respiratory disease that may make aerobic fitness assessment risky","Having significant vision or hearing loss that would impede understanding test instructions","Experiencing significant pain during measurements","Having cognitive impairment that would prevent understanding or answering questions - scoring below 24 on the Minimental Test"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 70 people at Isparta. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.979Z"},{"nctId":"NCT07816133","title":"Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.","officialTitle":"Endometriosis \"Atypical\" and Cancerized: Anatomopathological and Clinical-instrumental Characterization on the Ultrasound and Biological Characteristics of Atypical Endometriosis.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Casa di Cura Dott. Pederzoli","sponsorClass":"OTHER","summary":"This study hypothesizes that the histological, immunophenotypic, and molecular characterization of atypical endometriotic lesions may be related to specific clinical and ultrasound features.Identifying potentially atypical lesions would allow for more accurate stratification of patients, distinguishing definitely benign from potentially atypical endometriosis.\n\nThe targeted study of endometriosis, both typical and atypical, also with reference to the inflammatory microenvironment, as well as immunophenotypic and molecular characteristics, could allow the formulation of pathogenic hypotheses on the development and progression of atypia towards malignant neoplasms.","conditions":["Endometriosis"],"keywords":["endometrioma","immunohistochemical and molecular analysis","anatomopathological analysis"],"interventions":[{"type":"OTHER","name":"Retrospective case-control analysis"},{"type":"OTHER","name":"prospective case-control group"}],"enrollment":200,"startDate":"2026-10","completionDate":"2029-01","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\> 18 years\n* Candidate patients for endometriosis surgery with deep endometriosis (intestine, LUS) and/or endometrioma localizations.\n* Patients who are candidates for surgery for established or suspected endometrial and/or ovarian neoplasm\n* Patients who have performed a level II gynecological ultrasound with an experienced operator in the preoperative process.\n* Patients where there is the technical possibility of performing a transvaginal and/or transrectal ultrasound and the patient's willingness to undergo such an investigation.\n* Signing of informed consent.\n\nExclusion Criteria:\n\n* Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal).\n* Previous neoplasms\n* Patient who does not provide their informed consent.","locations":[{"facility":"Ospedale P. Pederzoli Casa di Cura Privata S.p.A.","city":"Peschiera del Garda","state":"Verona","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Identification of specific histopathological, immunohistochemical and molecular biology features for definable \"atypical\", \"preneoplastic\" or \"cancerized-neoplastic\" lesions and the surrounding microenvironment"],"hasResults":false,"conditionSlugs":["als","endometriosis"],"drugSlugs":[],"locationSlugs":["peschiera-del-garda-italy"],"enrichment":{"headline":"Not a traditional drug phase: Retrospective case-control analysis for Endometriosis","inPlainEnglish":"This study hypothesizes that the histological, immunophenotypic, and molecular characterization of atypical endometriotic lesions may be related to specific clinical and ultrasound features.Identifying potentially atypical lesions would allow for more accurate stratification of patients, distinguishing definitely benign from potentially atypical endometriosis. The targeted study of endometriosis, both typical and atypical, also with reference to the inflammatory microenvironment, as well as immunophenotypic and molecular characteristics, could allow the formulation of pathogenic hypotheses on the development and progression of atypia towards malignant neoplasms.","whoItsFor":["Ages 18 Years to any","Women only","Candidate patients for endometriosis surgery with deep endometriosis (intestine, LUS) and/or endometrioma localizations","Patients who are candidates for surgery for established or suspected endometrial and/or ovarian neoplasm","Patients who have performed a level II gynecological ultrasound with an experienced operator in the preoperative process","Patients where there is the technical possibility of performing a transvaginal and/or transrectal ultrasound and the patient's willingness to undergo such an investigation"],"whoShouldSkip":["Technical impossibility of performing a transvaginal ultrasound (patient virgo, patient refusal)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Peschiera del Garda. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.114Z"},{"nctId":"NCT07816367","title":"A Study to Assess the Efficacy and Safety of Elismetrep (K-304) in the Acute Treatment of Migraine","officialTitle":"A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Elismetrep (K-304) in the Acute Treatment of Migraine","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"TriGemX Bio, Inc.","sponsorClass":"INDUSTRY","summary":"This is a double-blind, randomized, multicenter, outpatient evaluation of the safety and efficacy of elismetrep, as compared with placebo, in the treatment of moderate or severe of migraine.","conditions":["Migraine"],"keywords":[],"interventions":[{"type":"DRUG","name":"Elismetrep"},{"type":"DRUG","name":"Placebo"}],"enrollment":1500,"startDate":"2026-10-02","completionDate":"2027-10","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1\\. Be a male or female, age 18 to 75 years, inclusive, at the time of signing informed consent.\n\n2\\. Has greater than a one-year history of migraine with or without aura as defined by International Headache Society criteria 1.1 and 1.2 and his/her migraines typically last between 4 to 72 hours, if untreated as documented in the patient's medical records from his/her treating physician or with pharmacy records confirming use of a migraine-specific medication (e.g. triptan, gepant, ditan) for \\> 1 year, and confirmed by the investigator. 3. Has had ≥2 and ≤10 moderate or severe migraine attacks per month in each of the 2 months prior to screening (Visit 1). 4. Meet the following requirements:\n\na. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:\n\n1. A minimum of 12 months of spontaneous amenorrhea or\n2. A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \\> 40 mIU/mL or\n3. At least 6 weeks post bilateral oophorectomy (with or without hysterectomy). OR ii. Post hysterectomy or bilateral salpingectomy, based on the subject's recall of their medical history OR c. Is a female of reproductive potential and: i. Agrees to remain abstinent from heterosexual activity\\* OR ii. Agrees to use (or have their partner use) a birth control method that is acceptable from the first dose of study drug until the End of Study visit.\n\nAcceptable methods of birth control are:\n\n1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal).\n2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable).\n3. Intrauterine device (IUD);\n4. Intrauterine hormone-releasing system (IUS);\n5. Bilateral tubal occlusion;\n6. Vasectomized partner;\n7. Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action;\n8. Male or female condom with or without spermicide;\n9. Cap, diaphragm or sponge with spermicide;\n10. A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods). \\* Abstinence can be used as the sole method of contraception if it is in line with the subject's preferred and usual lifestyle and if considered acceptable by local regulatory agencies and ethics committees. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.\n\n5\\. Voluntarily agrees to participate in the study by giving written informed consent. 6. Is able to read, understand and complete the study questionnaires and eDiary. 7. Be willing and able to comply with the study schedule of visits, all trial procedures and restrictions. 8. Be willing to use their own personal, qualified smartphone to download study specific eDiary applications for use during the study.\n\nExclusion Criteria:\n\nPatients are excluded from the trial if any of the following criteria apply:\n\n1. Is a female who is pregnant, breast-feeding, or intends to become pregnant during the planned course of the study. Note: Female participants of child-bearing potential must have a negative serum pregnancy test (β-human chorionic gonadotropin) performed by the central laboratory prior to enrollment in the study and negative urine pregnancy result at the randomization visit.\n\n   Migraine history-related\n2. Has difficulty distinguishing his/her migraine attacks from tension-type headaches.\n3. Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours.\n4. Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1).\n5. Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine.\n6. Was \\>50 years old at age of first migraine onset.\n7. Is taking migraine prophylactic medication where the prescribed dose has changed during the 3 months prior to screening (Visit 1) or anticipates any change during the study. Any withdrawal of preventive medications for the treatment of migraine should be completed at least 30 days prior to screening.\n\n   Medical history related\n8. Has, in the opinion of the investigator, other confounding pain syndromes, psychiatric conditions such as uncontrolled major depression, history of psychosis, dementia, or significant neurological disorders other than migraine \\[Patients who are currently being treated with non-prohibited medication for depression and symptoms are well controlled, in the opinion of the investigator, are eligible to participate in this study\\].\n9. Is at imminent risk of self-harm, based on clinical interview and responses on the Columbia Suicidality Severity Rating Scale (C-SSRS), or of harm to others in the opinion of the investigator. Patients must be excluded if they report suicidal ideation with intent, with or without a plan (i.e., Type 4 or 5 on the C-SSRS) in the past 2 months or suicidal behavior in the past 6 months.\n10. Has a recent history (within the past 3 years of the screening visit) or current diagnosis or evidence of endocrine, hematological, immunological (including Sjogren's syndrome), renal, respiratory, neurologic, gastrointestinal, biliary, or genitourinary abnormalities or diseases or hepatic impairment that, per the investigator's judgement, may jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.\n11. Has a history of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed if they have received treatment and follow-up consistent with local standard of care.\n12. Has a history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke or transient ischemic attack during the 6 months prior to screening.\n13. Has a history of human immunodeficiency virus disease.\n14. Has a history of gastric or small intestinal surgery (including gastric bypass surgery or banding but not including cholecystectomy or appendectomy) or has a disease that causes malabsorption.\n\n    Laboratory, vital sign, and electrocardiogram related\n15. Has a positive test result at screening for hepatitis B surface antigen, hepatitis C virus antibody.\n16. Has a screening estimated glomerular filtration rate estimated with the Modification of Diet in Renal Disease (MDRD) equation of \\<30 mL/min/1.73 m2.\n17. Has a screening result for alanine aminotransferase or aspartate aminotransferase of \\>2.0 X upper limit of normal (ULN) or total bilirubin \\>1.5 X ULN at the Screening visit. Note: An isolated bilirubin \\>1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin is within the laboratory normal range.\n18. Has a mean value for triplicate corrected QT interval to Fridericia's formula (QTcF) \\>450 ms for males and \\>470 ms for females at screening.\n19. Has a mean value for triplicate seated systolic blood pressure \\>160 mmHg and/or diastolic blood pressure \\>95 mmHg measured after at least 5 minutes at rest at the Screening Visit. Note: If a participant's blood pressure is exclusionary on the first triplicate assessment at the Screening Visit, they may have one repeat triplicate blood pressure assessment at that visit after another rest of at least 10 minutes.\n\n    Medication use and substance abuse related\n20. Has known history of or suspected abuse of alcohol or recreational drugs at Screening.\n21. Has use of soft drugs (such as marijuana or any substances containing tetrahydrocannabinol (THC) or cannabidiol (CBD) within 3 months prior to screening, or hard drugs (such as cocaine, illicit narcotics/opiates) within 6 months prior to screening.\n22. Has a positive drug screen at screening. Note:\n\n    1. If benzodiazepines are detected on the drug screen, this is not exclusionary if they are prescribed a benzodiazepine for a therapeutic purpose (e.g., for insomnia) and confirmatory documentation is obtained from the prescribing physician.\n    2. If amphetamines are detected on the drug screen, this is not exclusionary if the participant is taking a stimulant medication for a therapeutic purpose (e.g., Adderall for attention deficit hyperactivity disorder), confirmatory documentation is obtained from the prescribing physician, and the stimulant medication in question is known to be detected as amphetamine on the drug screen being used.\n23. Is currently in violation of study requirements for prohibited and permissible concomitant medications or treatments (not already specified in other criteria) or is anticipated to violate these requirements during study participation (detailed in the protocol).\n24. Has any use of prescription opiate medications within 14 days of screening or any anticipated/potential use of opiates during study participation.\n25. Has a history of use of ergotamine medications ≥10 days per month on a regular basis for ≥3 months prior to screening.\n26. Has a history of non-narcotic analgesic intake ≥15 days per month for ≥3 months prior to screening.\n\n    Other\n27. Has known or suspected hypersensitivity to trial product(s) or related products.\n28. Has a history of multiple significant and/or any severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.\n29. Has any surgery scheduled for the duration of the trial.\n30. Has a screening hemoglobin \\<11.0 g/dL (males) or \\<10.0 g/dL (females) or has a known hemoglobinopathy (e.g., sickle cell anemia, hemolytic anemia).\n31. Has previous participation in this trial. Participation is defined as signed informed consent.\n32. Has participated in any clinical trial of an approved or non-approved investigational biological medicinal product (e.g., antibody therapy) within 90 days of screening or has participated in any clinical trial of an approved or non-approved investigational small molecule medicinal product within 30 days or 5 half-lives (whichever is longer) of screening or ever signed an informed consent for Study K-304 P003. Note: Patients may not be screened at more than one trial site for this study.\n33. Has any other disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol, or otherwise interfere with interpretation of efficacy and/or safety results.\n34. Is an employee or immediate family member (e.g., spouse, parent, child, sibling) of the Sponsor or study site. Note: Rescreening/retesting is not permitted unless specified above.","locations":[{"facility":"Sun City Clinical Research","city":"Glendale","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research - Phoenix","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Preferred Research Partners, Inc.","city":"Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Alliance Research Institute, Canoga Park","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Chula Vista","city":"Chula Vista","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ark Clinical Research, Fountain Valley","city":"Fountain Valley","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Neurology Center of North Orange County","city":"Fullerton","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Axiom Research, Los Angeles LLC","city":"Glendale","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Long Beach Clinical Trials Services, Inc","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Long Beach","city":"Long Beach","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance Research Institute, Lynwood","city":"Lynwood","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northridge Clinical Trials","city":"Northridge","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pasadena Clinical Trials","city":"Pasadena","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC","city":"Redding","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Infinity Clinical Trials","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Optimus Medical Group","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Paragon Rx Clinical","city":"Santa Ana","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Van Nuys","city":"Van Nuys","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC; Aurora","city":"Aurora","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centennial Clinical Trials","city":"Denver","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ki Health Partners, LLC","city":"Stamford","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Hallandale Beach","city":"Hallandale","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of Central Florida","city":"Lakeland","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AppleMedical Research Group, LLC","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sensible Healthcare, LLC","city":"Ocoee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Associates of Orlando, LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cenexel Tampa FL","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Premiere Research Institute at Palm Beach Neurology","city":"West Palm Beach","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Integrative Research Center of Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evergreen Clinical Trials","city":"Norcross","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Savannah","city":"Savannah","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Paradigm Clinical Research Centers, LLC","city":"Boise","state":"Idaho","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Investigation Specialists, Inc.","city":"Gurnee","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Evanston Premier Healthcare Research, LLC","city":"Skokie","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research, Indianapolis","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Indiana Medical Research Institute","city":"Merrillville","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - McFarland |","city":"Ames","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Sioux City","city":"Sioux City","state":"Iowa","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NECCR PrimaCare Research, LLC","city":"Fall River","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Neurology Center of New England P.C.","city":"Foxborough","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Montana Medical Research, Inc","city":"Missoula","state":"Montana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Norfolk","city":"Norfolk","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Quality Clinical Research, Inc.","city":"Omaha","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oasis Clinical Research","city":"Las Vegas","state":"Nevada","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bio Behavioral Health","city":"Toms River","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Cary (Cary Medical Group)","city":"Cary","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"West Clinical Research","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Raleigh (Raleigh Medical Group, P.A.)","city":"Raleigh","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Wilmington","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Winston-Salem","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lillestol Research","city":"Fargo","state":"North Dakota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Cleveland","city":"Beachwood","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Cincinnati, Blue Ash","city":"Blue Ash","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Headache Center of Hope","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research; Columbus, Ohio","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Providence","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Anderson","city":"Anderson","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Gaffney","city":"Gaffney","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Central Texas Clinical Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Gadolin Research, LLC","city":"Beaumont","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research - DeSoto","city":"DeSoto","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Newco 3A Researh LLC, DBA 3A Research","city":"El Paso","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Red Star Research","city":"Lake Jackson","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Trials of Texas, LLC, A Flourish Research Site","city":"San Antonio","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Antonio Clinical Trials","city":"San Antonio","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research, Sugar Land","city":"Sugar Land","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research, Tomball","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wasatch Clinical Research, LLC","city":"Salt Lake City","state":"Utah","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Highland Clinical Research","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Annemarie Vance","phone":"917-336-3654","email":"annemarie@kallyope.com"}],"primaryOutcomes":["Pain freedom at 2 hours post-dose","Freedom from most bothersome symptoms (MBS) at 2 hours post-dose"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["glendale-arizona","phoenix-arizona","little-rock-arkansas","canoga-park-california","chula-vista-california","fountain-valley-california","fullerton-california","glendale-california","long-beach-california","lynwood-california","northridge-california","pasadena-california","redding-california","san-diego-california","san-francisco-california","santa-ana-california","van-nuys-california","aurora-colorado","denver-colorado","stamford-connecticut","hallandale-florida","lakeland-florida","miami-florida","ocoee-florida","orlando-florida","tampa-florida","west-palm-beach-florida","atlanta-georgia","norcross-georgia","savannah-georgia","boise-idaho","gurnee-illinois","skokie-illinois","indianapolis-indiana","merrillville-indiana","ames-iowa","sioux-city-iowa","fall-river-massachusetts","foxborough-massachusetts","missoula-montana","norfolk-nebraska","omaha-nebraska","las-vegas-nevada","toms-river-new-jersey","cary-north-carolina","morehead-city-north-carolina","raleigh-north-carolina","wilmington-north-carolina","winston-salem-north-carolina","fargo-north-dakota","beachwood-ohio","blue-ash-ohio","cincinnati-ohio","columbus-ohio","providence-rhode-island","anderson-south-carolina","gaffney-south-carolina","austin-texas","beaumont-texas","dallas-texas","desoto-texas","el-paso-texas","lake-jackson-texas","san-antonio-texas","sugar-land-texas","tomball-texas","salt-lake-city-utah"],"enrichment":{"headline":"Phase 3: testing Elismetrep for Migraine","inPlainEnglish":"This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, multicenter, outpatient evaluation of the safety and how well it works of elismetrep, as compared with dummy treatment (placebo), in the treatment of moderate or severe of migraine.","whoItsFor":["Ages 18 Years to 75 Years","a. Is a male OR b. Is a female who is of non-childbearing potential defined by at least one of the following criteria: i. Postmenopausal as defined by one of the following:","A minimum of 12 months of spontaneous amenorrhea or","A minimum of 6 months of spontaneous amenorrhea with a screening serum follicle-stimulating hormone level \\> 40 mIU/mL or","Acceptable methods of birth control are:","Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal)","Progestogen-only hormonal contraception associated with inhibition of ovulation (oral; injectable; or implantable)","Intrauterine device (IUD);"],"whoShouldSkip":["Patients are excluded from the trial if any of the following criteria apply:","Migraine history-related","Has difficulty distinguishing his/her migraine attacks from tension-type headaches","Has a history of predominantly mild migraine attacks or migraines that usually resolve spontaneously in less than 2 hours","Has more than 15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening (Visit 1)","Has brainstem (also known as basilar-type) or hemiplegic migraine headache, or retinal migraine","Was \\>50 years old at age of first migraine onset"],"whatHappens":"If you join, the listed intervention(s) are Elismetrep, or Placebo. The registry lists allocation as randomized. This is a neither you nor the study doctors know who gets the real treatment, randomly assigned, multicenter, outpatient evaluation of the safety and how well it works of elismetrep, as compared with dummy treatment (placebo), in the treatment of moderate or severe of migraine.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,500 people at 72 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.295Z"},{"nctId":"NCT07817147","title":"CREO - Microwave Ablation Feasibility Study","officialTitle":"Investigator-Initiated Feasibility Study of a Novel Endoscopic Ultrasound Guided Microwave Ablation Device in Patients With Locally Advanced, Unresectable, or Metastatic Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Banner Health","sponsorClass":"OTHER","summary":"The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.","conditions":["Pancreatic Cancer","Liver Cancer (Locally Advanced or Metastatic)","Pancreatic Cancer Non-resectable","Pancreatic Cancer Stage III","Pancreatic Cancer Stage IV","Liver Cancer Stage IV","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc"],"keywords":["Locally Advanced","Unresectable","Metastatic"],"interventions":[{"type":"DEVICE","name":"EUS-Guided MWA Device"}],"enrollment":75,"startDate":"2026-02-19","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female ≥18 years of age\n* Willing and able to provide written informed consent\n* Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV)\n* At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc).\n* The tumor(s) must be ≥1 cm in diameter\n\nExclusion Criteria:\n\n* Participant is a candidate for upfront resection of pancreatic cancer\n* Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study\n* Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being","locations":[{"facility":"Banner MD Anderson Cancer Center and Gateway Hospital","city":"Gilbert","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedars Sinai","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rush University Medical Center","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Tennessee Medical","city":"Knoxville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Memorial Hermann-Texas Medical Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"West Virginia University Medicine","city":"Morgantown","state":"West Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Neil Sharma, MD","phone":"(480) 356 - 6444","email":"neil.sharma@bannerhealth.com"}],"primaryOutcomes":["To assess the success of energy delivery during treatment with the device"],"hasResults":false,"conditionSlugs":["pancreatic-cancer","liver-cancer"],"drugSlugs":[],"locationSlugs":["gilbert-arizona","los-angeles-california","chicago-illinois","knoxville-tennessee","houston-texas","morgantown-west-virginia"],"enrichment":{"headline":"Not a traditional drug phase: EUS-Guided MWA Device for Pancreatic Cancer","inPlainEnglish":"The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer. Secondly, this study aims to explore the procedural/clinical safety of treatment with the device and the antitumor effect following treatment with the device.","whoItsFor":["Ages 18 Years to any","Male or female ≥18 years of age","Histologically confirmed locally advanced, unresectable or metastatic cancer (Stage III or IV)","At least 1 tumor that is indicated for MWA, and the location of target tumor must be accessible via EUS through the gastric wall (eg, pancreas, liver, etc)","The tumor(s) must be ≥1 cm in diameter"],"whoShouldSkip":["Participant is a candidate for upfront resection of pancreatic cancer","Participation in another clinical trial that involves local ablation or any other local therapy that could affect the target organ or lesions treated in this study","Any condition that, in the opinion of the investigator, may increase the risk to the participant's safety or well-being"],"whatHappens":"If you join, the listed intervention(s) are EUS-Guided MWA Device. The registry lists allocation as na. The goal of this study is to assess the overall success of energy delivery during treatment using the ultrasound guided microwave ablation device in patients with locally advanced, unresectable, or metastatic cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 75 people at 6 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.454Z"},{"nctId":"NCT07817875","title":"Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)","officialTitle":"Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks.\n\nParticipants who have completed the primary 104-week PW02 study (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.","conditions":["Obesity"],"keywords":["Pediatric","Children"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":150,"startDate":"2026-09-25","completionDate":"2029-12","sex":"ALL","minAge":"6 Years","maxAge":"11 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nJ4M-MC-PW02\n\n* Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)\n* Have:\n\n  * a body weight of ≥ 40 kilograms (kg) (88 pounds), and\n  * been diagnosed with obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart\n\nJ4M-MC-PWMP\n\n* Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening.\n* Obesity as defined by BMI equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \\[CDC-NCHS, 2022\\])\n\nExclusion Criteria:\n\nJ4M-MC-PW02\n\n* Have a history of\n\n  * proliferative diabetic retinopathy\n  * diabetic macular edema, or\n  * nonproliferative diabetic retinopathy that requires acute treatment\n\nJ4M-MC-PWMP\n\n* Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:\n\n  * gastric bypass\n  * sleeve gastrectomy\n  * restrictive bariatric surgery, such as Lap-Band® gastric banding, or\n  * any other procedure intended to result in weight reduction.\n* Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes.\n* Have type 1 diabetes or history of ketoacidosis, or hyperosmolar state.\n* Have HbA1c \\>9.0% (75 mmol/mol) as measured by central laboratory at screening.\n* Have a family or personal history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2.","locations":[{"facility":"University of Arizona","city":"Tucson","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Loma Linda University School of Medicine","city":"Loma Linda","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Childrens Hospital of Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UCLA Mattel Children's Hospital","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital of Orange County","city":"Orange","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Carey Chronis MD Pediatric, Infant and Adolescent Medicine","city":"Oxnard","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital Colorado","city":"Colorado Springs","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yale New Haven Children's Hospital","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Florida Hospital- Center for Pediatric Research","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nemours Children's Health","city":"Orlando","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"All Childrens Hospital","city":"St. Petersburg","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Healthcare of Atlanta - Center for Advanced Pediatrics","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ann and Robert H Lurie Children's Hospital of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Illinois at Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Riley Hospital for Children","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Norton Children's Endocrinology","city":"Louisville","state":"Kentucky","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Johns Hopkins Children's Center","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Boston Children's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Helen Devos Childrens' Hospital - PIN","city":"Grand Rapids","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota Masonic Children's Hospital","city":"Minneapolis","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mayo Clinic - PIN","city":"Rochester","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Minnesota Pediatric Endocrinology Clinic & McNeeley Diabetes Center","city":"Saint Paul","state":"Minnesota","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Children's Hospital & Medical Center","city":"Omaha","state":"Nebraska","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UBMD Pediatrics","city":"Buffalo","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UNC Children's Hospital","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Duke Children's Primary Care","city":"Durham","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lucas Research, Inc","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cincinnati Children's Hospital Medical Center","city":"Cincinnati","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Clinic","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nationwide Children's Hospital","city":"Columbus","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma Childrens Memorial Hospital","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Coastal Pediatric Associates","city":"Charleston","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical University of South Carolina Children Hospital","city":"Charleston","state":"South Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vanderbilt Health One Hundred Oaks","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dell Children's Medical Center - PIN","city":"Austin","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Driscoll Children's Hospital","city":"Corpus Christi","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"McGovern Medical School","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Texas Childrens Hospital","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"VCU Health - Center for Endocrinology Diabetes and Metabolism","city":"Richmond","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seattle Children's Research Institute - Hughes Building - PIN","city":"Seattle","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"MultiCare Health System - Mary Bridge Children's Health Center","city":"Tacoma","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc - PPDS","city":"Brussels","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Brussel","city":"Jette","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shamir Medical Center","city":"Beer Jacob","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Soroka Medical Center","city":"Beersheba","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Rambam Health Care Campus","city":"Haifa","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaare Zedek Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hadassah Medical Center","city":"Jerusalem","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Schneider Children's Medical Center","city":"Petah Tikva","state":"","country":"Israel","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Meyer","city":"Florence","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliera Universitaria Policlinico de Modena","city":"Modena","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria Maggiore della Carità","city":"Novara","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Azienda Ospedaliero Universitaria di Parma","city":"Parma","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesù","city":"Roma","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"PanAmerican Clinical Research - Guadalajara","city":"Guadalajara","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Investigacion Farmacologica Del Bajio Sc","city":"León","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Christus - Latam Hub Center of Excellence and Innovation S.C.","city":"Monterrey","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Panamerican Clinical Research Mexico","city":"Querétaro","state":"","country":"Mexico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UMED Clinical Trials","city":"Lodz","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kliniczny Szpital Wojewódzki Nr 2 im. SW Jadwigi Królowej w Rzeszowie","city":"Rzeszów","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ELIPSA - Elżbieta Lipska praktyka lekarska Ośrodek Endokrynologii i Diabetologii Dziecięcej","city":"Stanisławów Pierwszy","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ETG Justmed - PPDS","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Futuremeds Targowek","city":"Warsaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instytut Diabetologii - Warsaw","city":"Warszewo","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Premium Clinic Wrocław Centrum Medyczne","city":"Wroclaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Przychodnia FutureMeds Wrocław","city":"Wroclaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital da Luz Lisboa","city":"Lisbon","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro Materno Infantil do Norte","city":"Porto","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital CUF Porto","city":"Porto","state":"","country":"Portugal","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam-si","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Guro Hospital","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Infantil Universitario Niño Jesús","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Regional Universitario de Malaga - Hospital Materno-Infantil","city":"Málaga","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Corporacio Sanitaria Parc Tauli","city":"Sabadell","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Instituto Hispalense de Pediatria","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de Araba (HUA)- Hospital Txagorritxu","city":"Vitoria-Gasteiz","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Cheng-Kung Uni. Hosp.","city":"Tainan","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Taiwan University Hospital","city":"Taipei","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital - Linkou","city":"Taoyuan City","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"1-317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percent Change from Baseline in Body Mass Index (BMI)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["tucson-arizona","loma-linda-california","los-angeles-california","orange-california","oxnard-california","colorado-springs-colorado","new-haven-connecticut","orlando-florida","st-petersburg-florida","atlanta-georgia","chicago-illinois","indianapolis-indiana","louisville-kentucky","baltimore-maryland","boston-massachusetts","grand-rapids-michigan","minneapolis-minnesota","rochester-minnesota","saint-paul-minnesota","omaha-nebraska","buffalo-new-york","chapel-hill-north-carolina","durham-north-carolina","morehead-city-north-carolina","cincinnati-ohio","cleveland-ohio","columbus-ohio","oklahoma-city-oklahoma","charleston-south-carolina","nashville-tennessee","austin-texas","corpus-christi-texas","houston-texas","richmond-virginia","seattle-washington","tacoma-washington","brussels-belgium","jette-belgium","leuven-belgium","beer-jacob-israel","beersheba-israel","haifa-israel","jerusalem-israel","petah-tikva-israel","florence-italy","modena-italy","novara-italy","parma-italy","roma-italy","guadalajara-mexico","le-n-mexico","monterrey-mexico","quer-taro-mexico","lodz-poland","rzesz-w-poland","stanis-aw-w-pierwszy-poland","warsaw-poland","warszewo-poland","wroclaw-poland","lisbon-portugal","porto-portugal","seongnam-si-south-korea","seoul-south-korea","barcelona-spain","madrid-spain","m-laga-spain","sabadell-spain","seville-spain","vitoria-gasteiz-spain","tainan-taiwan","taipei-taiwan","taoyuan-city-taiwan"],"enrichment":{"headline":"Phase 3: testing Tirzepatide for Obesity","inPlainEnglish":"The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to measure the how well it works, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity. Participation in the study will last about 104 weeks.","whoItsFor":["Ages 6 Years to 11 Years","Are 6 to less than 12 years of age (Tanner stage 1 to 5 inclusive)","a body weight of ≥ 40 kilograms (kg) (88 pounds), and","been diagnosed with obesity, as defined by body-mass index (BMI) equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart","Have a history of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification program (diet and exercise counseling for at least 3 months) prior to screening","Obesity as defined by body-mass index (BMI) equal to or above the 95th percentile for age and sex (on age- and gender-specific growth chart \\[CDC-NCHS, 2022\\])"],"whoShouldSkip":["proliferative diabetic retinopathy","diabetic macular edema, or","nonproliferative diabetic retinopathy that requires acute treatment","Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to:","restrictive bariatric surgery, such as Lap-Band® gastric banding, or","any other procedure intended to result in weight reduction","Have a diagnosis that is a secondary cause of obesity or have a history of abrupt onset of obesity suggesting a secondary cause, such as hypothalamic, monogenetic, syndromic, or endocrine causes"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Placebo. The registry lists allocation as randomized. The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to measure the how well it works, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less than 12 years of age, with obesity.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 150 people at 82 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.019Z"},{"nctId":"NCT07818564","title":"Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation","officialTitle":"Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Brown University","sponsorClass":"OTHER","summary":"The primary aim of this phase I mechanistic pilot study is to evaluate the effects of psilocybin on aspects of cognition in healthy adult volunteers. Up to 24 participants will receive a single dose of either psilocybin or inert placebo, and they will be asked to complete several computer-based behavioral tasks measuring features of learning, belief updating, and abstraction. Participants will also complete measures of subjective experience and expectancy, as well as semi-structured interviews at follow up, to assess whether experience correlates with behavior. This is a Voluntary Submission.","conditions":["Phase I"],"keywords":["psilocybin","psychedelic","cognition","learning","healthy volunteers"],"interventions":[{"type":"DRUG","name":"Psilocybin (Usona Institute)"},{"type":"DRUG","name":"Inactive Placebo (Usona Institute)"}],"enrollment":24,"startDate":"2026-11","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. be at least 18 years old at time of signing informed consent\n2. be fluent in speaking and reading English\n3. be able to swallow pills (capsules)\n4. agree to use highly effective birth control for at least one month prior to enrollment, and for the duration of study enrollment, whether male or female assigned at birth. Acceptable methods include: copper or hormonal coil intrauterine device (IUD), implanted or injected hormonal method, documented permanent sterilization, documented not able to become pregnant, or oral/intravaginal/transdermal hormones plus a barrier contraception. Two forms of contraception are required with any barrier method or with any oral, intravaginal, or transdermal hormonal method due to these methods not being considered highly effective alone. Abstinence alone is not an acceptable contraceptive method for this study.\n5. be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a clinical interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine laboratory tests\n6. agree to inform investigators within 48 hours of any new medical conditions, treatments, or procedures\n7. agree to refrain from using any psychoactive or recreational drugs, including cannabis, for the duration of study enrollment (with the exception of limited alcohol, nicotine, and caffeine as below)\n8. agree to refrain from drinking alcohol within 24 hours of all experimental sessions\n9. agree to consume approximately the same amount of caffeine and nicotine as on a usual day before experimental sessions, but to not consume any nicotine or caffeine closer than 1 hour prior to the scheduled dosing time. If the participant does not routinely consume caffeine or nicotine, they must agree not to do so for the duration of the study.\n10. agree to refrain from taking any \"as needed\" or \"over the counter\" medications (e.g., medications for pain, insomnia, or allergies) within 24 hours of all experimental sessions, unless previously approved by a study physician\n11. agree to store their phone and car keys in a locked storage locker for the duration of the experimental dosing session, and agree to stay on site for at least 6 hours after drug administration and until a physician agrees they are safe to leave the premises\n12. be able to identify two trusted support people (e.g. friend or family member, at least age 18 years of age), who are willing and able to serve as an emergency contact, and to pick the participant up and transport them home after the dosing session. One of these will be designated the primary support person, and the second will be backup to pick the person up in the event that the primary becomes unavailable.\n13. agree to not drive a motor vehicle or heavy machinery for 24 hours after the dosing session\n14. have used a classical psychedelic (5-HT2A agonist, such as psilocybin, LSD, DMT, 5-MeO-DMT, ayahuasca, mescaline) at least once in lifetime without clinically significant adverse effects\n\nExclusion Criteria:\n\n1. have used any psychedelic, hallucinogen, or entactogen, including 3,4-methylenedioxymethamphetamine (MDMA) and ketamine/esketamine, but not including cannabis, within the past 3 months\n2. unwilling or unable to stop using cannabis a minimum of one week prior to enrollment and to refrain from cannabis use for the duration of the study enrollment, to be tested with urine drug screens\n3. currently pregnant (as indicated by a positive urine pregnancy test assessed at intake and before the drug session), nursing, intending to become pregnant within 3 months of enrollment, intending to father a child within 3 months of enrollment, intending to donate sperm or eggs within 3 months of enrollment, or not practicing a highly effective means of birth control as noted in the Inclusion Criteria.\n4. history of traumatic brain injury, or history of seizure disorder in adulthood\n5. history of any clinically significant cardiovascular condition, or condition that could make receiving the study drug harmful because of increases in blood pressure and heart rate. This includes, but is not limited to, uncontrolled hypertension, coronary artery disease, heart failure, stroke, myocardial infarction, artificial heart valve, aneurism, or clinically significant arrhythmia. Uncontrolled hypertension is defined here as repeated blood pressure readings of \\>= 140 mmHg systolic or \\>= 90 mmHg diastolic.\n6. baseline QTc \\> 450 milliseconds (QTc is defined as the QT interval corrected for heart rate, either machine-read or manually over-read)\n7. current poorly controlled or insulin dependent diabetes mellitus (type I or type II)\n8. current clinically significant respiratory condition (supplemental oxygen requirement, or requiring hospitalization within the last year)\n9. current clinically significant liver or biliary disease, including recent laboratory abnormalities (AST or ALT \\> 3x institutional upper limit of normal (ULN); total bilirubin \\> 1.5 x ULN or direct bilirubin \\< 35%), or based on the presence of ascites, encephalopathy, jaundice, esophageal varices, or coagulopathy\n10. clinically significant renal disease, including but not limited to CKD stage 3 or greater\n11. history of ever meeting Diagnostic and Statistical Manual, version 5 (DSM-5) criteria for any schizophrenia spectrum disorder, bipolar spectrum disorder, major depressive disorder with psychotic features, or any other psychotic disorder, including substance-induced psychotic disorders ever in lifetime\n12. have a first or second-degree relative with history of schizophrenia spectrum disorder, bipolar spectrum disorder, major depressive disorder with psychotic features, or other psychotic disorder including substance-induced psychotic disorders ever in lifetime\n13. clinically significant suicide risk, as determined by clinician judgment and the C-SSRS. Participants will be excluded if any current active suicidal ideation, including intent to kill oneself or preparatory behavior, or a lifetime history of suicide attempts including aborted or interrupted.\n14. history within last 5 years of inpatient psychiatric hospitalization for any reason\n15. lifetime history of hallucinogen persisting perception disorder\n16. current or history within the last 1 year of meeting DSM-5 criteria for an alcohol or substance use disorder, excluding caffeine and nicotine; or a lifetime history of hallucinogen use disorder\n17. a positive urine drug screen or alcohol breathalyzer test result on any study visit, or unwillingness to provide these tests\n18. history of antisocial personality disorder, borderline personality disorder, or narcissistic personality disorder\n19. taking a primary psychoactive medication on a regular basis within 3 months of study participation, including but not limited to antidepressants (SSRIs, SNRIs, NDRIs, MAOIs, TCAs), antipsychotics, mood stabilizers, anxiolytics, stimulants, or sedative-hypnotics\n20. current clinically significant episode of any other psychiatric disorder, including but not limited to a current episode of major depressive disorder, anxiety disorder, trauma- or stressor-related disorder, obsessive-compulsive disorder, neurodevelopmental disorder, and personality disorder that is not in full remission\n21. any other current problem which, in the opinion of study clinicians, might pose an unacceptable risk to participant or staff safety and/or significantly interfere with study participation","locations":[{"facility":"Brown University School of Public Health","city":"Providence","state":"Rhode Island","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Reinforcement Learning and Abstraction Task","Belief Updating Task"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["psilocybin"],"locationSlugs":["providence-rhode-island"],"enrichment":{"headline":"Phase 1: testing Psilocybin (Usona Institute) for Phase I","inPlainEnglish":"The primary aim of this phase I mechanistic pilot study is to measure the effects of psilocybin on aspects of cognition in healthy adult volunteers. Up to 24 participants will receive a single dose of either psilocybin or inert dummy treatment (placebo), and they will be asked to complete several computer-based behavioral tasks measuring features of learning, belief updating, and abstraction.","whoItsFor":["Ages 18 Years to any","be fluent in speaking and reading English","be able to swallow pills (capsules)","be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a clinical interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine laboratory tests","agree to inform investigators within 48 hours of any new medical conditions, treatments, or procedures","agree to refrain from using any psychoactive or recreational drugs, including cannabis, for the duration of study enrollment (with the exception of limited alcohol, nicotine, and caffeine as below)","agree to refrain from drinking alcohol within 24 hours of all experimental sessions","agree to refrain from taking any \"as needed\" or \"over the counter\" medications (e.g., medications for pain, insomnia, or allergies) within 24 hours of all experimental sessions, unless previously approved by a study physician"],"whoShouldSkip":["have used any psychedelic, hallucinogen, or entactogen, including 3,4-methylenedioxymethamphetamine (MDMA) and ketamine/esketamine, but not including cannabis, within the past 3 months","unwilling or unable to stop using cannabis a minimum of one week prior to enrollment and to refrain from cannabis use for the duration of the study enrollment, to be tested with urine drug screens","history of traumatic brain injury, or history of seizure disorder in adulthood","baseline QTc \\> 450 milliseconds (QTc is defined as the QT interval corrected for heart rate, either machine-read or manually over-read)","current poorly controlled or insulin dependent diabetes mellitus (type I or type II)","current clinically significant respiratory condition (supplemental oxygen requirement, or requiring hospitalization within the last year)","clinically significant renal disease, including but not limited to CKD stage 3 or greater"],"whatHappens":"If you join, the listed intervention(s) are Psilocybin (Usona Institute), or Inactive Placebo (Usona Institute). The registry lists allocation as randomized. The primary aim of this phase I mechanistic pilot study is to measure the effects of psilocybin on aspects of cognition in healthy adult volunteers.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 24 people at Providence. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.100Z"},{"nctId":"NCT07819773","title":"Device for Treating Generalized Anxiety","officialTitle":"Evaluation of the Efficacy and Safety of an Accelerated Protocol for Treating Generalized Anxiety Disorder Using the BTL-699-2 Device","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"BTL Industries Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with Generalized Anxiety Disorder (GAD). The main questions it aims to answer are:\n\nDoes the accelerated treatment protocol using the BTL-699-2 device reduce self-reported anxiety symptoms (as measured by the GAD-7 scale) 3 months after the final treatment? What are the safety and side effects associated with the use of the BTL-699-2 device during this accelerated protocol? Researchers will compare the active treatment group (Group A, receiving stimulation intensity of up to 70% of the individual's motor threshold) to a sham control group (Group B, receiving an inactive stimulation intensity of 5% of their motor threshold) to see if the active brain stimulation works to treat Generalized Anxiety Disorder.\n\nParticipants will:\n\n* Attend a screening/baseline visit to confirm GAD diagnosis (using the MINI diagnostic interview), review medical history, and establish their individual motor threshold.\n* Complete 8 study treatment visits scheduled twice weekly (2 to 4 days apart) over approximately 4 weeks. Each visit will consist of two consecutive 19-minute treatment sessions delivered at least 15 minutes apart (for a total of 16 treatments).\n* Complete self-reported and clinician-reported questionnaires assessing anxiety (GAD-7, HAM-A), depressive symptoms (PHQ-9), well-being (WEMWBS), suicidal risk (CSSRS), clinical improvement (CGI-I, PGI-I), and treatment comfort/satisfaction (TCQ, SSQ) at designated baseline, treatment, and follow-up visits.\n* Undergo a urine pregnancy test at baseline and once weekly (every other treatment visit) if they are women of childbearing potential.\n* Attend 2 follow-up visits scheduled at 1 month and 3 months after the final treatment to evaluate long-term outcomes and safety","conditions":["Generalized Anxiety Disorder (GAD)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"EXOMIND (BTL-699-2) Active treatment"},{"type":"DEVICE","name":"EXOMIND (BTL-699-2) Sham treatment"}],"enrollment":40,"startDate":"2026-09-09","completionDate":"2027-04-09","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 22 years\n* A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening\n* Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb\n* Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of anxiety, including non-invasive brain stimulation treatments other than the study procedure during study participation\n* Willingness to comply with study instructions and to return to the clinic for the required visits\n* Women of child-bearing potential\\* are required to use birth control measures during the whole duration of the study\n* If applicable, subjects must be maintained on their pre-study psychotherapeutic regimen and any prescribed chronic medications at a stable therapeutic dose for ≥4 weeks prior to enrollment, with no dose or usage frequency changes permitted during the study\n\n  * Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.\n\nExclusion Criteria:\n\n* Metallic objects in or near the head rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil.\\*\n* Implanted stimulator devices\n* Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death.\n* Drug pumps\n* Application in the heart area\n* Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)\n* Anticoagulation therapy\n* Severe or life-threatening condition\n* Pulmonary insufficiency\n* Heart disorders\n* Renal insufficiency\n* Decompensated\\*\\* hemorrhagic conditions\n* Decompensated\\*\\* blood coagulation disorders\n* Decompensated\\*\\* cardiovascular diseases\n* Malignant tumor or benign tumor\n* Fever\n* Pregnancy\n* Active suicidal intent\\*\\*\\*\n* History of suicide attempts in the last 3 years\n* History or concurrent use of electroconvulsive therapy or vagus nerve stimulation\n* Substance-induced depression or depression secondary to a general medical condition\n* Seasonal affective disorder\n* Substance abuse\n* Substance dependence 3 months prior\n* A psychotic disorder including schizoaffective disorder, bipolar disease, borderline personality disorder or major depression with psychotic features\n* Neurological disorders, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, cerebral aneurysm, dementia, or movement disorders\n* Ongoing intake disorders such as bulimia or anorexia, or intake disorder in the past fiscal year\n* History of increased intracranial pressure or head trauma\n* Nursing\n* Any other disease or condition at the investigator's discretion that may pose risk to the patient or compromise the study\n\n  * Examples include cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes. Failure to follow this restriction could result in serious injury or death. Certain exceptions apply to mouth implants, such as standard amalgam dental fillings, single post dental implants, dental bridge work, and braces. If these items are present, the therapy can still be administered.\n\n    * By means of decompensation, it means a patient with a proven medical history of a decompensated health condition and long-term medication. Patients who use certain medications only for preventive purposes, without any proven previous health condition failure, are not considered contraindicated.\n\n      * Defined by a score of Level 4 or Level 5 on the Columbia-Suicide Severity Rating Scale (CSSRS).","locations":[{"facility":"Aria Integrative Health","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Study by AC","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cady Wellness Institute","city":"Newburgh","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Evaluation of the change in self-reported anxiety symptoms 3 months post-treatment."],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["denver-colorado","chicago-illinois","newburgh-indiana"],"enrichment":{"headline":"Not a traditional drug phase: EXOMIND (BTL-699-2) Active treatment for Generalized Anxiety Disorder (GAD)","inPlainEnglish":"The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with Generalized Anxiety Disorder (GAD). The main questions it aims to answer are: Does the accelerated treatment protocol using the BTL-699-2 device reduce self-reported anxiety symptoms (as measured by the GAD-7 scale) 3 months after the final treatment?","whoItsFor":["Ages 22 Years to any","A diagnosis of GAD according to DSM-5 criteria, confirmed by a qualified clinician at screening","Ability to determine the motor threshold of the participant. The participant's motor threshold could be established as the minimum stimulus required to induce contraction of the right thumb","Subjects willing and able to abstain from partaking in any treatments other than the pre-procedure therapy regime for the treatment of anxiety, including non-invasive brain stimulation treatments other than the study procedure during study participation","Willingness to comply with study instructions and to return to the clinic for the required visits","Women of child-bearing potential\\* are required to use birth control measures during the whole duration of the study","If applicable, subjects must be maintained on their pre-study psychotherapeutic regimen and any prescribed chronic medications at a stable therapeutic dose for ≥4 weeks prior to enrollment, with no dose or usage frequency changes permitted during the study","Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause"],"whoShouldSkip":["Metallic objects in or near the head rTMS devices are contraindicated for use in patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or within 12 in (30 cm) of the treatment coil.\\*","Implanted stimulator devices","Active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, ocular implants and vagus nerve stimulators. Contraindicated use could result in serious injury or death","Application in the heart area","Persons with a tendency to seizure (e.g., persons suffering from hypotonia and epilepsy)","Anticoagulation therapy","Severe or life-threatening condition"],"whatHappens":"If you join, the listed intervention(s) are EXOMIND (BTL-699-2) Active treatment, or EXOMIND (BTL-699-2) Sham treatment. The registry lists allocation as randomized. The goal of this clinical trial is to learn if treatment with the BTL-699-2 device (non-invasive repetitive transcranial magnetic stimulation) can decrease anxiety symptoms in adults (aged 22 years and older) diagnosed with Generalized Anxiety Disorder (GAD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at 3 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.354Z"},{"nctId":"NCT07820046","title":"Nitazoxanide as Adjunct Therapy in Mild-to-Moderate Ulcerative Colitis","officialTitle":"Nitazoxanide in Mild-to-Moderate Ulcerative Colitis: A Randomized, Double-Blind, Placebo-Controlled Trial","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Tanta University","sponsorClass":"OTHER","summary":"Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance. Emerging evidence suggests that intestinal barrier dysfunction, microbiota dysbiosis, and immune dysregulation play central roles in UC pathogenesis.\n\nNitazoxanide is a broad-spectrum antiparasitic agent with demonstrated antimicrobial, anti-inflammatory, and immunomodulatory effects, including inhibition of NF-κB signaling and improvement of intestinal barrier integrity. Preclinical studies suggest potential benefit in experimental colitis models; however, clinical evidence remains limited.\n\nThis randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of nitazoxanide as an adjunct to standard therapy in patients with mild-to-moderate ulcerative colitis over a 12-week treatment period.","conditions":["Ulcerative Colitis (UC)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nitazoxanide (NTZ)"}],"enrollment":44,"startDate":"2026-10-25","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n* Age 18-65 years\n* Confirmed ulcerative colitis ≥ 6 months\n* Mild-to-moderate active disease (Mayo score 3-10)\n* Stable UC therapy ≥ 8 weeks before enrollment Exclusion Criteria\n* Severe/fulminant UC requiring hospitalization or surgery\n* Active intestinal infection (e.g., C. difficile)\n* Antibiotics/probiotics/investigational drugs within 4 weeks\n* Recent biologic initiation or dose change\n* Severe hepatic, renal, cardiovascular disease, or malignancy\n* Pregnancy or lactation\n* Known hypersensitivity to nitazoxanide","locations":[{"facility":"Tanta university hospital","city":"Tanta","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tanta University Hospital","city":"Tanta","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Khadija Glal","phone":"+201118969649","email":"khadija.ahmed@pharm.tanta.edu.eg"}],"primaryOutcomes":["Change in Mayo Score (Mayo Scoring System for Ulcerative Colitis)"],"hasResults":false,"conditionSlugs":["ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["tanta-egypt"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Nitazoxanide (NTZ) for Ulcerative Colitis (UC)","inPlainEnglish":"Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa. Despite advances in therapeutic options, many patients experience incomplete remission or treatment resistance.","whoItsFor":["Ages 18 Years to 65 Years","Confirmed ulcerative colitis ≥ 6 months","Mild-to-moderate active disease (Mayo score 3-10)","Stable UC therapy ≥ 8 weeks before enrollment"],"whoShouldSkip":["Severe/fulminant UC requiring hospitalization or surgery","Active intestinal infection (e.g., C. difficile)","Antibiotics/probiotics/investigational drugs within 4 weeks","Recent biologic initiation or dose change","Severe hepatic, renal, cardiovascular disease, or malignancy","Pregnancy or lactation","Known hypersensitivity to nitazoxanide"],"whatHappens":"If you join, the listed intervention(s) are Nitazoxanide (NTZ). The registry lists allocation as randomized. Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the colonic mucosa.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 44 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.202Z"},{"nctId":"NCT07820189","title":"Effects of Microelectrode-based Brain Stimulation in Humans","officialTitle":"Effects of Microelectrode-based Brain Stimulation in Humans","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Lund University","sponsorClass":"OTHER","summary":"The currently available treatments of Parkinson's disease (PD) and Essential Tremor (ET) are inadequate and accompanied by adverse side effects making the treatment much less effective. This includes treatments with pharmaceuticals as well as electrical brain stimulation (DBS; Deep Brain Stimulation). To address this challenge, we have systematically worked to identify and overcome the shortcomings with current brain stimulation. Essential has been to achieve an understanding of the mechanisms behind the ubiquitous tissue reactions (often referred to as \"foreign body reactions\"), with loss of nerve cells near implanted electrodes and how to accomplish minimal tissue reactions/damage, which is necessary to enable therapeutically efficient low-intensity stimulation at precise locations. A further challenge relates to individual differences at the level of neuronal networks, making the exact sites in the brain that cause therapeutic and adverse side effects when stimulated not known in advance and thus requiring individual determination. Our strategy has therefore been to develop highly biocompatible microelectrodes (thinner than a human hair and highly flexible) and a guiding investigational device for controlled insertion of a cluster of such microelectrodes in deep target tissue. This enables individualized selection of appropriate stimulation sites. This technique, termed by us \"High Definition Brain Stimulation\" (HDBS), proved remarkably successful in animal models of both Parkinson's disease and pain by reliably providing powerful symptom relief without noticeable adverse side effects. For this first in human (FIH) investigation of microelectrode-based brain stimulation, we have systematically minimized all identified and foreseeable risks through optimization of the microelectrodes, the design of the investigational device for HDBS and development of simple minimally invasive surgical insertion methods. Extensive monitored safety tests in animals have confirmed the picture of negligeable tissue reactions/damage and absence of bleeding in the target area. Biological safety is also ensured by using only well-established materials documented for chronic implantation in the brain, established sterilization methods, identified safe stimulation intensities, and that the insertion procedures are adapted to well-established precision neurosurgical instruments and routines. The study is an early (FIH) feasibility clinical investigation which will be conducted in up to 12 patients with Parkinson's disease and/or Essential Tremor who are already scheduled for implantation of established DBS. The HDBS device will be inserted into awake patients in the same track as planned for the established DBS electrode. The evaluation will follow a protocol that includes stimulation of predetermined subsets of microelectrodes at up to 4 predetermined levels (depth) in the brain. The stimulation intensity for each subgroup is gradually increased until either a therapeutic effect or an undesirable side effect has been achieved. If an unacceptable effect is elicited, stimulation is immediately interrupted and a new subset of electrodes will be tested. After completion of the evaluation, the HDBS cluster electrode is removed and the implantation of an established permanent DBS electrode is completed. The evaluation will take up to 2.5 hours per patient. The patient's verbal responses, gestures, changes (if any) in tremors, rigidity, speech ability (such as slurring) or facial expressions before, during and after stimulation will be linked to the stimulation parameters (stimulation intensity, subgroup of microelectrodes, depth in the brain and time of reaction) and documented in writing and through video recordings. The analysis will only be made on anonymized data. The primary objective of this early feasibility, FIH, clinical investigation is to clarify whether HDBS (High Definition Brain Stimulation), through individualized stimulation of appropriate subgroups of implanted biocompatible microelectrodes, can provide a powerful therapeutic effect with minimal negative side effects also in humans. In addition, it is intended to simultaneously obtain important information that can be used by the neurosurgeon to improve the subsequent placement of the already scheduled permanent DBS electrode in the individual patient and thereby improve the treatment. Consequently, the secondary objective is to clarify whether HDBS can be used by the neurosurgeon to improve the placement of a permanent DBS electrode. The project paves the way for permanent HDBS with completely new opportunities for powerful, sustainable therapy with minimal side-effects in Parkinson's disease, Essential Tremor and other intractable neurologic disorders. Moreover, the HDBS technology enables new and potent opportunities for brain research.","conditions":["Essential Tremor","Parkinsons Disease (PD)"],"keywords":["First in human feasibility study","Microelectrode based deep brain stimulation","Essential Tremor","Parkinson's disease"],"interventions":[{"type":"DEVICE","name":"High Definition Brain Stimulation (HDBS)"}],"enrollment":12,"startDate":"2026-10-15","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The target population for the clinical device to be investigated are adult patients with Parkinson's disease or essential tremor that are already scheduled for permanent implantation of devices for deep brain stimulation. This implies that these patients are an already selected group of patients deemed to be appropriate patients for DBS.\n* Patients that are fully capable of understanding the patient information.\n* Patients that accept to be awake during the investigation\n* Patients that accept to be video-filmed during the investigation.\n\nExclusion Criteria:\n\n* Patients that do not accept to be awake during the stimulation procedure.\n* Patients for which the intended extension of surgery time (up to 2,5 hours) is considered by the neurosurgeon to be an unacceptable risk.\n* Patients with a known history of blood clotting disorder.\n* Patients with a known history of bleeding disorder.\n* Patients under age 18.\n* Pregnant women and women that are breast feeding.","locations":[{"facility":"Skane University Hospital","city":"Lund","state":"Skåne County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jens Schouenborg, PhD","phone":"+46702924572","email":"jens.schouenborg@med.lu.se"},{"name":"Hjalmar Bjartmarz, MD","phone":"+46705343055","email":"hjalmar.bjartmarz@skane.se"}],"primaryOutcomes":["Changes in motor performance during microelectrode based deep brain stimulation"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["lund-sweden"],"enrichment":{"headline":"Not a traditional drug phase: High Definition Brain Stimulation (HDBS) for Essential Tremor","inPlainEnglish":"The currently available treatments of Parkinson's disease (PD) and Essential Tremor (ET) are inadequate and accompanied by adverse side effects making the treatment much less effective. This includes treatments with pharmaceuticals as well as electrical brain stimulation (DBS; Deep Brain Stimulation).","whoItsFor":["Ages 18 Years to any","Patients that are fully capable of understanding the patient information","Patients that accept to be awake during the investigation","Patients that accept to be video-filmed during the investigation"],"whoShouldSkip":["Patients that do not accept to be awake during the stimulation procedure","Patients for which the intended extension of surgery time (up to 2,5 hours) is considered by the neurosurgeon to be an unacceptable risk","Patients with a known history of blood clotting disorder","Patients with a known history of bleeding disorder","Patients under age 18","Pregnant women and women that are breast feeding"],"whatHappens":"If you join, the listed intervention(s) are High Definition Brain Stimulation (HDBS). The registry lists allocation as na. The currently available treatments of Parkinson's disease (PD) and Essential Tremor (ET) are inadequate and accompanied by adverse side effects making the treatment much less effective.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 12 people at Lund. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.671Z"},{"nctId":"NCT07820800","title":"NMR Metabolomics-Based Risk Assessment and Stratified Digital Health Interventions in Middle-Aged Adults (PREMAP)","officialTitle":"Effectiveness and Cost-Effectiveness of NMR Metabolomics-Based Risk Assessment and Stratified Preventive Digital and Guideline-Directed Interventions in a Middle-Aged Population: A Population Cohort Study With an Embedded Pragmatic Randomised Trial and Health Economic Evaluation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University of Eastern Finland","sponsorClass":"OTHER","summary":"PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, and fatty liver disease), alongside a mental wellbeing assessment (WHO-5 Well-Being Index). Based on this risk profile, participants are classified as low, moderate, or high multi-disease risk. Participants at moderate or high risk are individually randomized in a 1:1:1 ratio to one of three digital health interventions for up to 12 months: a habit-based lifestyle application (BitHabit), a structured digital lifestyle coaching programme (Onnikka), or a guideline-based digital self-care pathway (Oma Eloisa, comparator). Participants at high risk additionally receive a physician consultation and optimization of guideline-directed medical therapy. All participants, including the non-randomized low-risk group, are followed prospectively at baseline, 6 months, and 12 months. The study evaluates whether early risk identification and risk-stratified digital interventions reduce future disease risk and improve wellbeing and estimates the cost-effectiveness of the overall approach for the Finnish healthcare system.","conditions":["Type 2 Diabetes","Coronary Heart Disease","Myocardial Infarction","Cerebrovascular Disease","Stroke","Chronic Kidney Disease","Fatty Liver Disease"],"keywords":["cardio-renal-metabolic risk","preventive medicine","metabolomics","digital health intervention","risk stratification","primary prevention","wellbeing","health economics"],"interventions":[{"type":"BEHAVIORAL","name":"Digital health interventions"}],"enrollment":1400,"startDate":"2026-09","completionDate":"2027-09","sex":"ALL","minAge":"45 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Permanent resident of the Eloisa Wellbeing Services County (South Savo, Finland), or has selected Eloisa primary health care as their primary public care provider\n* Turning 45, 50, or 55 years of age during calendar year 2026\n* NMR metabolomics-based risk assessment result classified as low, moderate, or high multi-disease risk\n* Able to provide written informed consent digitally\n* Able to use a smartphone, tablet, or computer for digital application access\n* Resident of Finland with a Finnish personal identity code (required for health register linkage)\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding\n* Incarcerated or under forensic psychiatric care\n* Significantly impaired capacity for self-determination\n* Insufficient proficiency in Finnish to provide informed consent and complete study procedures\n* No Finnish personal identity code","locations":[{"facility":"Wellbeing Services County of South Savo (Eloisa) (provide social and healthcare services and emergency services in the Enonkoski, Hirvensalmi, Juva, Kangasniemi, Mikkeli, Mäntyharju, Pieksämäki, Puumala, Rantasalmi, Savonlinna ja Sulkava)","city":"Savonlinna","state":"","country":"Finland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Janne Martikainen, PhD, Professor","phone":"+3583552600","email":"janne.martikainen@uef.fi"}],"primaryOutcomes":["NMR-derived disease-specific 10-year risk predictions","The World Health Organization-Five Well-Being Index (WHO-5)"],"hasResults":false,"conditionSlugs":["stroke","type-2-diabetes","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["savonlinna-finland"],"enrichment":{"headline":"Not a traditional drug phase: Digital health interventions for Type 2 Diabetes","inPlainEnglish":"PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, and fatty liver disease), alongside a mental wellbeing assessment (WHO-5 Well-Being Index). Based on this risk profile, participants are classified as low, moderate, or high multi-disease risk.","whoItsFor":["Ages 45 Years to 55 Years","Permanent resident of the Eloisa Wellbeing Services County (South Savo, Finland), or has selected Eloisa primary health care as their primary public care provider","Turning 45, 50, or 55 years of age during calendar year 2026","NMR metabolomics-based risk assessment result classified as low, moderate, or high multi-disease risk","Able to use a smartphone, tablet, or computer for digital application access","Resident of Finland with a Finnish personal identity code (required for health register linkage)"],"whoShouldSkip":["Currently pregnant or breastfeeding","Incarcerated or under forensic psychiatric care","Significantly impaired capacity for self-determination","No Finnish personal identity code"],"whatHappens":"If you join, the listed intervention(s) are Digital health interventions. The registry lists allocation as randomized. PREMAP invites residents of the Eloisa region (South Savo, Finland) turning 45, 50, or 55 years of age in 2026 to undergo a blood-based NMR metabolomics risk assessment for five interlinked cardio-renal-metabolic conditions (type 2 diabetes, coronary heart disease/myocardial infarction, stroke/cardiovascular disease, chronic kidney disease, and fatty liver disease), alongside a mental wellbeing assessment (WHO-5 Well-Being Index).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,400 people at Savonlinna. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.164Z"},{"nctId":"NCT07821450","title":"Blepharoptosis After Repeated Intravitreal Anti-VEGF Injections: A Prospective Study","officialTitle":"Prospective Evaluation of Blepharoptosis Development in Patients Undergoing Repeated Intravitreal Anti-VEGF Injections","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Abdulkadir Küçük","sponsorClass":"OTHER","summary":"Intravitreal anti-VEGF injections are a mainstay of treatment for retinal diseases such as neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, and usually require repeated administration over years. During each injection an eyelid speculum holds the lids open and the upper eyelid is exposed to repeated mechanical stretch. Aponeurotic ptosis after intraocular surgery is well described, but evidence on blepharoptosis after repeated intravitreal injections is limited and conflicting.\n\nThis single-center prospective observational study enrolls 60 patients who are starting intravitreal anti-VEGF therapy in one eye only; the untreated fellow eye of each patient serves as an internal control. Upper eyelid position and function are assessed with margin reflex distance-1 (MRD-1), margin reflex distance-2 (MRD-2) and levator function at baseline and at months 1, 3 and 6. The primary endpoint is the difference between the injected eye and the fellow eye in the change in MRD-1 from baseline to month 6.","conditions":["Blepharoptosis","Age-Related Macular Degeneration","Diabetic Macular Edema"],"keywords":["intravitreal injection","anti-VEGF","eyelid speculum","blepharostat","margin reflex distance","aponeurotic ptosis"],"interventions":[{"type":"OTHER","name":"Repeated intravitreal anti-VEGF injection with eyelid speculum"}],"enrollment":60,"startDate":"2026-09-25","completionDate":"2027-06-25","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Planned initiation of intravitreal anti-VEGF injection in one eye only for a retinal disease\n* No prior intravitreal injection in either eye\n* Able to attend the scheduled follow-up visits and to cooperate for the duration of the study\n* Reliable MRD-1, MRD-2 and levator function measurement possible in both eyes (clear corneal light reflex, clearly visible eyelid margin, able to maintain primary gaze)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pre-existing blepharoptosis or significant eyelid malposition at the baseline examination\n* Previous ptosis surgery, blepharoplasty or other eyelid surgery that may affect upper eyelid anatomy\n* History of myasthenia gravis, oculomotor nerve palsy, Horner syndrome, facial nerve palsy or a similar neurologic or neuromuscular disorder\n* History of orbital trauma, orbital surgery or orbital disease\n* Advanced dermatochalasis, eyelid retraction, entropion, ectropion or marked facial asymmetry precluding reliable eyelid measurement\n* Need for intravitreal injection in both eyes during the study period\n* Ocular or periocular surgery during follow-up that may affect upper eyelid position\n* Inability to comply with follow-up visits or incomplete measurements\n* Withdrawal of consent\n* Inability to obtain reliable eyelid measurements due to severe blepharospasm, advanced corneal opacity, marked eyelid edema, or inability to maintain head or neck position or to cooperate","locations":[{"facility":"University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Abdulkadir Küçük, MD","phone":"+90 538 572 5722","email":"akkucuk42@gmail.com"},{"name":"Fatih Çoban, MD","phone":"+90 5392346206","email":"cobanfatih_92@hotmail.com"}],"primaryOutcomes":["Between-eye difference in the change in margin reflex distance-1 (MRD-1) from baseline to month 6"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Repeated intravitreal anti-VEGF injection with eyelid speculum for Blepharoptosis","inPlainEnglish":"Intravitreal anti-VEGF injections are a mainstay of treatment for retinal diseases such as neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, and usually require repeated administration over years. During each injection an eyelid speculum holds the lids open and the upper eyelid is exposed to repeated mechanical stretch.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Planned initiation of intravitreal anti-VEGF injection in one eye only for a retinal disease","No prior intravitreal injection in either eye","Able to attend the scheduled follow-up visits and to cooperate for the duration of the study","Reliable MRD-1, MRD-2 and levator function measurement possible in both eyes (clear corneal light reflex, clearly visible eyelid margin, able to maintain primary gaze)"],"whoShouldSkip":["Pre-existing blepharoptosis or significant eyelid malposition at the baseline examination","Previous ptosis surgery, blepharoplasty or other eyelid surgery that may affect upper eyelid anatomy","History of myasthenia gravis, oculomotor nerve palsy, Horner syndrome, facial nerve palsy or a similar neurologic or neuromuscular disorder","History of orbital trauma, orbital surgery or orbital disease","Advanced dermatochalasis, eyelid retraction, entropion, ectropion or marked facial asymmetry precluding reliable eyelid measurement","Need for intravitreal injection in both eyes during the study period","Ocular or periocular surgery during follow-up that may affect upper eyelid position"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at Istanbul. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.144Z"},{"nctId":"NCT07821658","title":"A Postmarketing Study of Lecanemab for the Treatment of Participants With Alzheimer's Disease","officialTitle":"A 10-Year, Postmarketing, Multicenter, Safety Surveillance Study of Lecanemab-irmb for the Treatment of Participants With Alzheimer's Disease in Real-World Clinical Practice (Using Alzheimer's Network for Treatment and Diagnostics [ALZ-NET] Registry Data)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Eisai Inc.","sponsorClass":"INDUSTRY","summary":"The primary purpose of this study is to evaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 cm in participants treated with lecanemab-irmb.\n\nThe secondary purpose of this study is to:\n\nEvaluate the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.\n\nAssess the safety of lecanemab-irmb when stratified by baseline characteristics including apolipoprotein E (APOE) genotype, baseline magnetic resonance imaging (MRI) findings consistent with a high risk for cerebral amyloid angiopathy (CAA), prior Alzheimer's Disease (AD) treatments, and antithrombotic therapy.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior AD treatment, and antithrombotic therapy within participants exposed to lecanemab-irmb in ALZ-NET.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and subjects exposed to lecanemab irmb in Study 301.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event,and death) between participants exposed to lecanemabirmb in ALZ-NET and subjects exposed to placebo (PBO) in Study 301.\n\nAssess the risk of safety outcomes (ARIA-E, ARIA-H, ICH greater than 1 cm, seizures, anaphylaxis, CNS ischemic event, and death) between participants exposed to lecanemab-irmb in ALZ-NET and participants not exposed to anti-amyloid therapies in ALZ-NET.\n\nAssess whether the risk of safety outcomes associated with APOE genotype, baseline MRI findings consistent with high risk for CAA, prior Alzheimer's Disease treatments, and antithrombotic therapy differs between participants exposed to lecanemab-irmb in ALZ-NET versus those not exposed to anti-amyloid therapies in ALZ-NET.","conditions":["Alzheimer's Disease"],"keywords":["Alzheimer's Disease","Early Alzheimer's Disease","LEQEMBI","ARIA"],"interventions":[{"type":"OTHER","name":"No Intervention"}],"enrollment":6700,"startDate":"2025-05-23","completionDate":"2035-01-15","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Enrolled in ALZ-NET\n* Either currently receiving or previously received lecanemab-irmb.\n\nExclusion Criteria:\n\n-None","locations":[{"facility":"Eisai Trial Site #1","city":"Nutley","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Eisai Medical Information","phone":"+1-888-274-2378","email":"esi_medinfo@eisai.com"}],"primaryOutcomes":["Incidence and exposure-adjusted incidence rate of the adverse events of special interest (AESIs) of ARIA-E, symptomatic ARIA-E, ARIA-H, symptomatic ARIA-H, and ICH greater-than 1 cm in diameter"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":["lecanemab"],"locationSlugs":["nutley-new-jersey"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention for Alzheimer's Disease","inPlainEnglish":"The primary purpose of this study is to measure the safety of lecanemab-irmb in the real-world clinical setting as reported by events of amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E), ARIA-hemosiderin deposition (ARIA-H), symptomatic ARIA-E, symptomatic ARIA-H, and intracerebral hemorrhage (ICH) greater-than 1 cm in participants treated with lecanemab-irmb. The secondary purpose of this study is to: measure the safety of lecanemab-irmb in the real-world clinical setting as reported by events of seizures, anaphylaxis, central nervous system (CNS) ischemic event, and death.","whoItsFor":["Enrolled in ALZ-NET","Either currently receiving or previously received lecanemab-irmb"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 6,700 people at Nutley. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:23.230Z"},{"nctId":"NCT07823101","title":"Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis","officialTitle":"Advancing Bulbar Assessment in Inclusion Body Myositis Through a Multimodal Imaging Approach","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"This study will evaluate whether neuromuscular ultrasound and MRI can be used as imaging markers of bulbar involvement and swallowing dysfunction in individuals with inclusion body myositis (IBM). Researchers will compare imaging and clinical findings in participants with IBM with those in participants with other myopathies, ALS, PLS, and healthy volunteers.\n\nThe study is a one-time visit. Study procedures may include neurological assessments, swallowing questionnaires, tongue strength testing, neuromuscular ultrasound, and MRI. The goal is to identify more sensitive and objective ways to assess bulbar dysfunction biomarkers.","conditions":["IBM","Inclusion Body Myositis","Myopathy","Myositis","ALS (Amyotrophic Lateral Sclerosis)","PLS"],"keywords":["swallowing","tongue weakness","bulbar weakness","weakness"],"interventions":[],"enrollment":30,"startDate":"2026-11","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of inclusion body myositis (IBM), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), or myopathy in accordance with the respective diagnostic criteria.\n* Participants with disease must have clinically relevant laboratory testing for disease biomarkers (e.g., Creatine Kinase (CK), Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC)) within the last 12 months.\n* Participants must be able to remain supine for 30 minutes or longer and cannot have significant breathing difficulties.\n* Healthy controls must not have any neuromuscular disease.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide written informed consent.\n* Medical history or clinically significant physical examination or laboratory results that, in the opinion of the investigator, would render the participant unsuitable for the study.\n* Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.\n* Patients with IBM, ALS, or myopathy who have another known neuromuscular condition with known bulbar involvement.\n* Any patient who has undergone a procedure for dysphagia, including myotomy, dilatation, or Botox.","locations":[{"facility":"The Johns Hopkins Hospital","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joseph D Niang, B.A.","phone":"410-570-3949","email":"jniang1@jh.edu"},{"name":"Pamela Arrazola, M.S.","phone":"410-955-0749","email":"parrazo1@jh.edu"}],"primaryOutcomes":["Bulbar Muscle Thickness Assessed by Neuromuscular Ultrasound","Bulbar Muscle Cross-Sectional Area Assessed by Neuromuscular Ultrasound","Bulbar Muscle Echogenicity Assessed by Quantitative Grayscale Ultrasound","Bulbar Muscle Echogenicity Assessed by the Heckmatt Grading Scale","Bulbar Muscle Volume Assessed by Magnetic Resonance Imaging","Bulbar Muscle Cross-Sectional Area Assessed by Magnetic Resonance Imaging","Bulbar Muscle Fat Content Assessed by Magnetic Resonance Imaging","Tongue Muscle Stiffness Assessed by Ultrasound Elastography"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Imaging Assessment of Swallowing and Speech Muscles in Inclusion Body Myositis","inPlainEnglish":"This study will evaluate whether neuromuscular ultrasound and MRI can be used as imaging markers of bulbar involvement and swallowing dysfunction in individuals with inclusion body myositis (IBM). Researchers will compare imaging and clinical findings in participants with IBM with those in participants with other myopathies, ALS, PLS, and healthy volunteers.","whoItsFor":["Ages 18 Years to any","Participants must have a confirmed diagnosis of inclusion body myositis (IBM), amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), or myopathy in accordance with the respective diagnostic criteria","Participants with disease must have clinically relevant laboratory testing for disease biomarkers (e.g., Creatine Kinase (CK), Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC)) within the last 12 months","Participants must be able to remain supine for 30 minutes or longer and cannot have significant breathing difficulties","Healthy controls must not have any neuromuscular disease"],"whoShouldSkip":["Medical history or clinically significant physical examination or laboratory results that, in the opinion of the investigator, would render the participant unsuitable for the study","Participants who are unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study","Patients with IBM, ALS, or myopathy who have another known neuromuscular condition with known bulbar involvement","Any patient who has undergone a procedure for dysphagia, including myotomy, dilatation, or Botox"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 30 people at Baltimore. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.604Z"},{"nctId":"NCT07823608","title":"A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \\[OSA\\]) and overweight or obesity who use a breathing machine (positive airway pressure \\[PAP\\] machine).\n\nPeople may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training.\n\nDuring the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.","conditions":["Apnea","Sleep Disorders","Overweight and/or Obesity"],"keywords":["Sleep Apnea","Obesity","Overweight","Sleep Disorders","Vesper"],"interventions":[{"type":"DRUG","name":"Berobenatide"},{"type":"OTHER","name":"Placebo"}],"enrollment":258,"startDate":"2026-09-17","completionDate":"2028-04-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Body mass index (BMI) ≥27 kg/m² at screening\n* Previously diagnosed with moderate to severe obstructive sleep apnea (OSA)\n* Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study.\n\nExclusion Criteria:\n\n* Self-reported body weight change of more than 5% within 90 days prior to screening\n* Diagnosis of any type of diabetes (resolved gestational diabetes is permitted)\n* History of acute or chronic pancreatitis\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) Sleep-disordered breathing conditions other than obstructive sleep apnea that could interfere with study assessments or interpretation of results (eg, central sleep apnea, mixed sleep apnea, Cheyne-Stokes respiration, obesity hypoventilation syndrome, or significant craniofacial abnormalities).","locations":[{"facility":"Cullman Clinical Trials","city":"Cullman","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Preferred Research Partners, Inc.","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Probe Clinical Research Corporation","city":"Riverside","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revive Research Institute, Inc.","city":"Southfield","state":"Michigan","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research - Twin Cities","city":"Maplewood","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Dallas","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research","city":"Tomball","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change From Baseline in Apnea-Hypopnea Index (AHI)"],"hasResults":false,"conditionSlugs":["obesity","sleep-apnea"],"drugSlugs":[],"locationSlugs":["cullman-alabama","little-rock-arkansas","riverside-california","bradenton-florida","southfield-michigan","maplewood-minnesota","dallas-texas","tomball-texas"],"enrichment":{"headline":"Phase 3: testing Berobenatide for Apnea","inPlainEnglish":"This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \\[OSA\\]) and overweight or obesity who use a breathing machine (positive airway pressure \\[PAP\\] machine).","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Body mass index (body-mass index (BMI)) ≥27 kg/m² at screening","Previously diagnosed with moderate to severe obstructive sleep apnea (OSA)","Ongoing positive airway pressure (PAP) therapy for obstructive sleep apnea that is expected to continue during the study"],"whoShouldSkip":["Self-reported body weight change of more than 5% within 90 days prior to screening","Diagnosis of any type of diabetes (resolved gestational diabetes is permitted)","History of acute or chronic pancreatitis"],"whatHappens":"If you join, the listed intervention(s) are Berobenatide, or Placebo. The registry lists allocation as randomized. This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 258 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.941Z"},{"nctId":"NCT07823842","title":"T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD","officialTitle":"Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation Across the Spectrum of Chronic Airway Diseases - A Prospective Observational Study in Asthma and COPD","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Shanghai Pulmonary Hospital, Shanghai, China","sponsorClass":"OTHER","summary":"This prospective, real-world observational study (T2AIR Study) evaluates the long-term efficacy and safety of six biologics targeting Type 2 inflammation - omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and depemokimab - in patients with chronic airway diseases, including asthma and COPD under routine clinical practice in China.\n\nThe primary objective is to determine the annualized exacerbation rate (AER) over 12 months of treatment. Secondary objectives include time to first exacerbation, frequency of severe exacerbations, improvements in symptom control and quality of life (using disease-specific questionnaires), lung function (FEV₁, FVC), airway inflammatory biomarkers (FeNO, blood eosinophils, serum IgE), oral corticosteroid (OCS) sparing effect in asthma patients, and treatment persistence.\n\nSafety outcomes will assess the incidence, types, and severity of adverse events (AEs) and serious adverse events (SAEs). Exploratory endpoints include high-resolution CT (HRCT)-based imaging markers of airway remodeling and the development of deep learning-based multimodal predictive models integrating clinical, biomarker, and radiomics data to support personalized treatment. Additionally, blood, sputum, and urine samples will be collected for translational research to explore underlying mechanisms and predictors of biologic response.\n\nThis study aims to generate robust real-world evidence on the effectiveness and safety of Type 2-targeted biologics across the broad spectrum of chronic airway diseases in a diverse Chinese patient population.","conditions":["Asthma","COPD (Chronic Obstructive Pulmonary Disease)"],"keywords":["asthma","copd","bronchiectasis","ABPA","Biologics","Type 2 inflammation"],"interventions":[{"type":"DRUG","name":"Biologics targeting Type 2 inflammation"},{"type":"DRUG","name":"Patients with asthma and copd who received standard of care"}],"enrollment":538,"startDate":"2026-07-30","completionDate":"2029-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nSubjects must meet all of the following criteria:\n\n1\\. Age ≥ 18 years; 2. Confirmed diagnosis of at least one of the following chronic airway diseases:\n\n1. Asthma: Diagnosed according to the 2025 GINA guidelines, with typical variable respiratory symptoms (wheeze, shortness of breath, chest tightness, or cough) and objective evidence of variable expiratory airflow limitation (positive bronchodilator reversibility test, positive bronchial provocation test, average daily PEF variability \\>10%, improvement in lung function after ICS treatment, or significant variability in lung function between two visits).\n2. Chronic Obstructive Pulmonary Disease (COPD): Diagnosed according to the 2026 GOLD guidelines, with symptoms of dyspnea, chronic cough, or sputum production, and/or history of exposure to risk factors, and post-bronchodilator FEV₁/FVC \\< 70%.\n\n3\\. Meets clinical indications for biologic therapy as judged by a respiratory or allergy specialist according to current guidelines:\n\n1. Asthma: Poor control despite optimized high-dose ICS-LABA therapy, presence of allergic or eosinophilic inflammatory biomarkers, or severe/refractory disease requiring maintenance oral corticosteroids (OCS).\n2. COPD: Frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), with blood eosinophil count (EOS) ≥ 300/μL and chronic bronchitis phenotype.\n\n4\\. The treating respiratory or allergy specialist has decided to initiate or switch to one of the following approved biologics targeting Type 2 inflammation, based on 2025 GINA and 2026 GOLD guidelines: omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, or depemokimab (tezepelumab may be used in both Type 2 and non-Type 2 inflammation).\n\n5\\. Able and willing to provide written informed consent and commit to at least 12 months of follow-up.\n\nExclusion Criteria\n\nSubjects will be excluded if they meet any of the following criteria:\n\n1. Presence of severe or uncontrolled pulmonary or systemic diseases (e.g., active malignancy, autoimmune disease) or active infectious respiratory diseases (e.g., active pulmonary tuberculosis or infectious pneumonia);\n2. Pregnant, breastfeeding, or planning pregnancy during the study period;\n3. Known history of hypersensitivity or allergy to any component of the planned biologic agent;\n4. Expected life expectancy less than 12 months;\n5. Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation (e.g., poor compliance or inability to complete follow-up).","locations":[{"facility":"Shanghai Pulmonary Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gao Yong-hua, PhD, MD","phone":"+8617321278520","email":"gaoyonghuahust@163.com"}],"primaryOutcomes":["Annual rate of protocol-defined exacerbations of chronic airway disease over 12 months"],"hasResults":false,"conditionSlugs":["asthma","copd"],"drugSlugs":["dupilumab","tezepelumab"],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Biologics targeting Type 2 inflammation for Asthma","inPlainEnglish":"This prospective, real-world watch-and-measure (no experimental treatment required) study (T2AIR Study) evaluates the long-term how well it works and safety of six biologics targeting Type 2 inflammation - omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and depemokimab - in patients with chronic airway diseases, including asthma and COPD under routine clinical practice in China. The primary objective is to determine the annualized exacerbation rate (AER) over 12 months of treatment.","whoItsFor":["Ages 18 Years to any","Subjects must meet all of the following criteria:","1\\. Age ≥ 18 years; 2. Confirmed diagnosis of at least one of the following chronic airway diseases:","Chronic Obstructive Pulmonary Disease (COPD): Diagnosed according to the 2026 GOLD guidelines, with symptoms of dyspnea, chronic cough, or sputum production, and/or history of exposure to risk factors, and post-bronchodilator FEV₁/FVC \\< 70%","3\\. Meets clinical indications for biologic therapy as judged by a respiratory or allergy specialist according to current guidelines:","Asthma: Poor control despite optimized high-dose ICS-LABA therapy, presence of allergic or eosinophilic inflammatory biomarkers, or severe/refractory disease requiring maintenance oral corticosteroids (OCS)","COPD: Frequent exacerbations despite triple inhaled therapy (ICS + LABA + LAMA), with blood eosinophil count (EOS) ≥ 300/μL and chronic bronchitis phenotype"],"whoShouldSkip":["Subjects will be excluded if they meet any of the following criteria:","Presence of severe or uncontrolled pulmonary or systemic diseases (e.g., active malignancy, autoimmune disease) or active infectious respiratory diseases (e.g., active pulmonary tuberculosis or infectious pneumonia);","Pregnant, breastfeeding, or planning pregnancy during the study period;","Known history of hypersensitivity or allergy to any component of the planned biologic agent;","Expected life expectancy less than 12 months;","Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation (e.g., poor compliance or inability to complete follow-up)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 538 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.710Z"},{"nctId":"NCT07825064","title":"Cevostamab in Combination With Pomalidomide and Dexamethasone After BCMA- Targeting CAR T-Cell Therapy in Participants With Previously Treated Multiple Myeloma","officialTitle":"A Phase II, Single Arm, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination With Pomalidomide and Dexamethasone in Patients With Multiple Myeloma Who Have Received a Prior BCMA-Targeting CAR T-Cell Therapy","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess the efficacy and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.","conditions":["Multiple Myeloma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Cevostamab"},{"type":"DRUG","name":"Pomalidomide"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Tocilizumab"}],"enrollment":45,"startDate":"2026-11-03","completionDate":"2029-04-13","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment.\n* Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy\n* Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria\n* Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line\n* Participants must have measurable disease during screening\n\nExclusion Criteria:\n\n* Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)\n* Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells\n* History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab\n* Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs\n* Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required.","locations":[{"facility":"Klinikum Nürnberg Nord","city":"Nuremberg","state":"Bavaria","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsmedizin Greifswald","city":"Greifswald","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNI-Klinikum Heidelberg Medizinische Klinik Innere Medizin V","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Jena, Klinik für Innere Medizin II","city":"Jena","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"UKSH, Campus Kiel","city":"Kiel","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CO46577 https://forpatients.roche.com/No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest Response:use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Overall Response Rate (ORR) as assessed by an Independent Review Committee"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":["car-t"],"locationSlugs":["nuremberg-germany","greifswald-germany","heidelberg-germany","jena-germany","kiel-germany"],"enrichment":{"headline":"Phase 2: testing Cevostamab for Multiple Myeloma","inPlainEnglish":"This study wants to assess the how well it works and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening and immediately prior to the start of administration of study treatment","Received one to four lines of prior therapy, including prior B-cell maturation antigen (BCMA)-targeting Chimeric Antigen Receptors (CAR) T-cell therapy","Multiple Myeloma diagnosis according to the International Myeloma Working Group (IMWG) diagnostic criteria","Is triple-class exposed, i.e. received anti- cluster of differentiation 38 (CD38) therapy, a proteasome inhibitor (PI) and lenalidomide in any prior line","Participants must have measurable disease during screening"],"whoShouldSkip":["Known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy or documented within serum amyloid P component scan)","Plasma cell leukemia or circulating plasma cell count exceeding 500 cells/µL or 5% of the peripheral blood white cells","History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or known hypersensitivity to any of the excipients of cevostamab","Gastrointestinal (GI) disease that might significantly alter absorption of oral drugs","Known active Central Nervous System (CNS) involvement, or exhibits clinical signs of meningeal involvement of MM. If either is suspected, negative whole-brain MRI and lumbar cytology are required"],"whatHappens":"If you join, the listed intervention(s) are Cevostamab, Pomalidomide, or Dexamethasone. The registry lists allocation as na. This study wants to assess the how well it works and safety of cevostamab in combination with pomalidomide and dexamethasone (CevosPd) in patients with multiple myeloma (MM) who have received one to four prior lines of therapy and have been exposed to an anti-cluster of differentiation 38 (CD38) antibody, lenalidomide, a proteasome inhibitor (PI) and a B cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 45 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.496Z"},{"nctId":"NCT07825311","title":"Prevention of Ischemic Stroke Recurrence Using Digital Technology Application","officialTitle":"Prevention of Ischemic Stroke Recurrence Using Digital Technology Application: a Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Affiliated Hospital of Nantong University","sponsorClass":"OTHER","summary":"The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke. The investigators also want to see whether this program helps with controlling blood pressure, blood sugar, and blood lipids, as well as with taking medications correctly, improving daily habits, and supporting emotional well-being.\n\nThe investigators are focusing on two main questions:\n\n* After using this digital management tool, will the chance of having another stroke within one year after leaving the hospital be lower?\n* Compared with people who only receive regular care, will those who use the tool show better control of blood pressure, blood sugar, and blood lipids, better medication adherence, and healthier lifestyles?\n\nPeople who join the study will be randomly assigned to one of two groups. One group will receive usual stroke prevention care (the control group). The other group will get the same usual care plus an additional 12-month program that includes a smart bracelet and a mobile app (the intervention group).\n\nIf participants are in the intervention group, participants will:\n\n* Wear a smart bracelet continuously and use a mobile app for 12 months.\n* Receive health tips, medication reminders, blood-pressure measurement reminders, activity goals, and vibration alerts when participants have been sitting too long through the app.\n\nIf participants are in either group, participants will:\n\n* Come to the clinic for check-ups and assessments at the start of the study, and again at 3 months, 6 months, and 12 months.\n* Have neurological function of participants, daily activity abilities, quality of life, medication adherence, and mood (depression and anxiety) assessed at those visits.\n* Have blood tests to check metabolic risk factors of participants(e.g., blood lipids and glucose) at the same visits.\n* Report to the research team if participants experience another stroke, any cardiovascular event, or death at each follow-up visit.\n\nThe investigators will compare the two groups to see if the digital program makes a real difference in reducing stroke recurrence and improving overall health after a stroke.","conditions":["Ischemic Stroke","Digital Health"],"keywords":["ischemic stroke","digital health","risk factor"],"interventions":[{"type":"DEVICE","name":"Digital Prevention Management"},{"type":"OTHER","name":"Usual Stroke Secondary Prevention Management"}],"enrollment":1696,"startDate":"2026-09-01","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosed with ischemic stroke within the past 3 months, confirmed by cranial CT or MRI.\n* Have both hypertension and diabetes as concurrent metabolic risk factors for stroke recurrence.\n* Possess basic communication skills and ability to understand the study content and provide written informed consent.\n* The participant or their primary caregiver is able to use a smart wearable device, has access to a smartphone, and is willing to complete follow-up visits as required by the study protocol.\n\nExclusion Criteria:\n\n* Life expectancy less than 12 months, or presence of severe cardiac, hepatic, renal, or other systemic diseases that would make participation in follow-up inappropriate.\n* Severe cognitive impairment, aphasia, psychiatric disorders, or disturbance of consciousness that prevents cooperation with the study, without a stable caregiver to assist.\n* Severe physical disability or other reasons that preclude wearing or using the wearable device.\n* Currently participating in another interventional study that may affect stroke recurrence outcomes.","locations":[{"facility":"Affiliated Hospital of Nantong University","city":"Nantong","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Qiuhong Ji","phone":"+8613962916293","email":"jiqiuhong@ntu.edu.cn"},{"name":"Lei Li","phone":"+8613815434184","email":"lilei.nj@live.cn"}],"primaryOutcomes":["Number of Participants With First Recurrent Stroke"],"hasResults":false,"conditionSlugs":["als","stroke","depression"],"drugSlugs":[],"locationSlugs":["nantong-china"],"enrichment":{"headline":"Not a traditional drug phase: Digital Prevention Management for Ischemic Stroke","inPlainEnglish":"The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke. The investigators also want to see whether this program helps with controlling blood pressure, blood sugar, and blood lipids, as well as with taking medications correctly, improving daily habits, and supporting emotional well-being.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Diagnosed with ischemic stroke within the past 3 months, confirmed by cranial CT or MRI","Have both hypertension and diabetes as concurrent metabolic risk factors for stroke recurrence","The participant or their primary caregiver is able to use a smart wearable device, has access to a smartphone, and is willing to complete follow-up visits as required by the study protocol"],"whoShouldSkip":["Life expectancy less than 12 months, or presence of severe cardiac, hepatic, renal, or other systemic diseases that would make participation in follow-up inappropriate","Severe cognitive impairment, aphasia, psychiatric disorders, or disturbance of consciousness that prevents cooperation with the study, without a stable caregiver to assist","Severe physical disability or other reasons that preclude wearing or using the wearable device","Currently participating in another treatment study that may affect stroke recurrence outcomes"],"whatHappens":"If you join, the listed intervention(s) are Digital Prevention Management, or Usual Stroke Secondary Prevention Management. The registry lists allocation as randomized. The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 1,696 people at Nantong. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.213Z"},{"nctId":"NCT07825454","title":"Pilot Study of Hydroxychloroquine for the Treatment of AIMSS","officialTitle":"A Phase II Single-Arm Pilot Study of Hydroxychloroquine for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Indiana University","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.","conditions":["Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)","Joint Pain","Breast Cancer"],"keywords":["Hydroxychloroquine","Joint Pain","Aromatase Inhibitor Associated Musculoskeletal Symptoms (AMISS)"],"interventions":[{"type":"DRUG","name":"Hydroxychloroquine Sulfate (HCQ)"}],"enrollment":35,"startDate":"2026-10-19","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of informed consent\n2. Ability to provide written informed consent and HIPAA authorization\n3. Diagnosis of DCIS or stage I, II, or III breast cancer\n4. Currently receiving adjuvant aromatase inhibitor therapy (anastrozole, letrozole or exemestane) for ≥ 4 weeks prior to enrollment Note: Concurrent use of ovarian suppression is allowed Note: Concurrent use of CDK4/6 inhibitors is not allowed due to cytopenia risk\n5. New or worsening self-reported musculoskeletal pain that began or significantly worsened after initiation of AI therapy\n6. BPI average pain score of ≥ 4 during screening\n7. ECOG PS 0-2\n8. Adequate organ function:\n\n   1. Absolute neutrophil count ≥1,500/µL\n   2. Hemoglobin ≥11.0 g/dL\n   3. Platelet count ≥100,000/µL\n   4. Serum creatinine ≤1.5× upper limit of normal (ULN) or eGFR ≥60 mL/min/1.73m2\n   5. Total bilirubin ≤1.5× ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin \\< 3.0 mg/dL)\n   6. AST and ALT ≤1.5× ULN\n9. Must agree to maintain stable doses of any analgesic medications or other AIMSS related therapies during the study period Note: rescue doses of acetaminophen or ibuprofen allowed on a non-daily basis, unless not new\n\nExclusion Criteria:\n\n1. Current or prior use of hydroxychloroquine or chloroquine within 6 months\n2. Known hypersensitivity to hydroxychloroquine, chloroquine, or 4-aminoquinoline compounds\n3. History of retinopathy or retinal vein occlusion issues Note: While there is an association between retinopathy and HCQ use, this occurs rarely and with long term use with higher cumulative doses that used here. Other clinical trials have not required retinal exam (example: CTO-TBCRC04627, approved by IU IRB)\n4. History of congestive heart failure (any NYHA class)\n5. QTc prolongation (\\>450 msec) at screening or history of significant arrhythmias requiring treatment\n6. Moderate to severe renal impairment (eGFR \\<60 mL/min/1.73m2)\n7. Use of a prohibited concomitant medication (refer to Section 6.3.2) that cannot be discontinued or changed to an alternate therapy\n8. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency\n9. History of porphyria\n10. History of psoriasis\n11. History of antiepileptic medications\n12. Known history of inflammatory arthritis (example: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) or connective tissue disease (example: systemic lupus erythematosus, scleroderma, polymyositis)\n13. Recent initiation or dose change (within 4 weeks) of medications for pain management (NSAIDs, duloxetine, gabapentin, pregabalin, opioids) Note: Patients on stable doses for \\>4 weeks are eligible\n14. Patients currently receiving or planned to receive high dose systemic treatment with corticosteroids defined as: cortisone \\>50mg; hydrocortisone \\>40mg, prednisone \\>10mg, methylprednisolone \\>8mg or dexamethasone \\>1.5mg; or another immunosuppressive agent Note: Topical or inhaled corticosteroids are allowed\n15. Other active malignancy other than breast cancer requiring systemic therapy\n16. Pregnant or lactating\n17. Co-enrollment in another clinical trial Note: Patients may co-enroll in other clinical trial(s) if the trial(s) does not interfere with the objectives of this trial\n18. Significant psychiatric illness, in the opinion of the investigator, that would limit compliance with study requirements\n19. Any active suicidality or history of active suicidal ideation/behavior/attempt within 1 year prior to screening\n20. Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation","locations":[{"facility":"Indiana University Melvin and Bren Simon Comprehensive Cancer Center","city":"Indianapolis","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Niraj Shah, MS","phone":"317-278-3420","email":"shahnir@iu.edu"}],"primaryOutcomes":["To evaluate the efficacy of hydroxychloroquine"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["indianapolis-indiana"],"enrichment":{"headline":"Phase 2: testing Hydroxychloroquine Sulfate (HCQ) for Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)","inPlainEnglish":"This study wants to measure the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.","whoItsFor":["Ages 18 Years to any","Diagnosis of DCIS or stage I, II, or III breast cancer","Currently receiving adjuvant aromatase inhibitor therapy (anastrozole, letrozole or exemestane) for ≥ 4 weeks prior to enrollment Note: Concurrent use of ovarian suppression is allowed Note: Concurrent use of CDK4/6 inhibitors is not allowed due to cytopenia risk","New or worsening self-reported musculoskeletal pain that began or significantly worsened after initiation of AI therapy","BPI average pain score of ≥ 4 during screening","Adequate organ function:","Absolute neutrophil count ≥1,500/µL","Hemoglobin ≥11.0 g/dL"],"whoShouldSkip":["Current or prior use of hydroxychloroquine or chloroquine within 6 months","Known hypersensitivity to hydroxychloroquine, chloroquine, or 4-aminoquinoline compounds","History of congestive heart failure (any NYHA class)","QTc prolongation (\\>450 msec) at screening or history of significant arrhythmias requiring treatment","Moderate to severe renal impairment (eGFR \\<60 mL/min/1.73m2)","Use of a prohibited concomitant medication (refer to Section 6.3.2) that cannot be discontinued or changed to an alternate therapy","Known glucose-6-phosphate dehydrogenase (G6PD) deficiency"],"whatHappens":"If you join, the listed intervention(s) are Hydroxychloroquine Sulfate (HCQ). The registry lists allocation as na. This study wants to measure the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 35 people at Indianapolis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.965Z"},{"nctId":"NCT07825597","title":"Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma","officialTitle":"Low-Dose Incremental First-Window Indocyanine Green With Near Infrared Imaging for Intraoperative Visualization of Head and Neck Squamous Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"This study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery. Patients receive ICG as part of their clinical care, independently of whether they participate in this study. The study plans to enroll 25 adults undergoing surgery for confirmed or strongly suspected cancer. Researchers will record near-infrared images obtained during clinical ICG use, compare them with tissue pathology, and measure the strength, timing, and duration of fluorescence. The research analysis will not guide clinical or surgical decisions. Participants will be followed through 24 hours after surgery.","conditions":["Head and Neck Squamous Cell Carcinoma"],"keywords":["Indocyanine green","ICG","First-window imaging","Near-infrared fluorescence imaging","Tumor-to-background ratio","Intraoperative imaging"],"interventions":[{"type":"DRUG","name":"Indocyanine green"},{"type":"PROCEDURE","name":"Near-infrared fluorescence imaging"}],"enrollment":25,"startDate":"2026-09-30","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection.\n* At least 18 years of age.\n* The effects of ICG on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to surgery and for 1 week after surgery. Should a woman become pregnant or suspect she is pregnant during this time or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study.\n* Thyroid radioactive uptake study within 1 week of ICG administration.\n* Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery.","locations":[{"facility":"Washington University School of Medicine","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bharat Panuganti, MD, FACS","phone":"314-362-7522","email":"bharatp@wustl.edu"}],"primaryOutcomes":["Tumor-to-background ratio (TBR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Phase 2: testing Indocyanine green for Head and Neck Squamous Cell Carcinoma","inPlainEnglish":"This study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy. ICG is a fluorescent dye given into a vein during surgery.","whoItsFor":["Ages 18 Years to any","Histologically or cytologically confirmed, or strong clinical suspicion contingent on standard of care pre-operative assessment, of head and neck squamous cell carcinoma (HNSCC), preparing to undergo surgical resection","At least 18 years of age"],"whoShouldSkip":["A history of allergic reactions attributed to compounds of similar chemical or biologic composition to ICG, sodium iodide, or other agents used in the study","Thyroid radioactive uptake study within 1 week of ICG administration","Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 1 day of surgery"],"whatHappens":"If you join, the listed intervention(s) are Indocyanine green, or Near-infrared fluorescence imaging. The registry lists allocation as na. This study will examine how closely first-window indocyanine green (ICG) fluorescence corresponds to the extent of head and neck squamous cell carcinoma identified by tissue biopsy.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 25 people at St Louis. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.337Z"},{"nctId":"NCT07825857","title":"Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder","officialTitle":"Randomized Controlled Trial of Tirzepatide for Methamphetamine Use Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of Texas Southwestern Medical Center","sponsorClass":"OTHER","summary":"This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial evaluating the tolerability, safety, and preliminary efficacy of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD.\n\nParticipants will undergo study procedures over 32 weeks, including:\n\n1. completing self-assessments\n2. undergo brief physical and review of medical and psychiatric history\n3. provide urine and blood samples\n4. medical management sessions\n5. weekly subcutaneous study medication injections","conditions":["Methamphetamine Use Disorder"],"keywords":["methamphetamine","MUD","methamphetamine use disorder","tirzepatide","substance use","GLP-1"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Placebo (saline)"}],"enrollment":228,"startDate":"2026-10-23","completionDate":"2031-07-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* be aged 18 to 65 years;\n* have moderate or severe methamphetamine use disorder;\n* have active pattern of methamphetamine use;\n* be interested in reducing or stopping methamphetamine use;\n* be able and willing to provide informed consent, comply with all study procedures, and adhere to weekly study medication injections;\n* be overweight or obese (body mass index ≥25 kg/m²); and\n* (only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant\n\nExclusion Criteria:\n\n* report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days;\n* have a current eating disorder or severe alcohol or substance use disorder;\n* have personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia type 2, or hypersensitivity, angioedema, or anaphylaxis to GLP-1RAs or tirzepatide;\n* have Stage 3 or higher chronic kidney disease, inadequately controlled diabetes, history of diabetic retinopathy, any unstable or serious medical or psychiatric condition, or any other reason or clinical condition that may either interfere with study participation or make the study participation unsafe (per investigator judgement);\n* are currently pregnant, breastfeeding, or planning pregnancy;\n* have received an investigational drug within 30 days of informed consent;\n* require psychiatric hospitalization;\n* have recent suicidal or current homicidal ideation;\n* are incarcerated or in court-mandated residential placement;\n* have unsafe use of alcohol, benzodiazepines, sedative/hypnotics, or other substances; or\n* have use of concurrent medications that may pose safety risks or interfere with study procedures.","locations":[{"facility":"University of Southern California (USC)","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Center of Substance Use and Health","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Oklahoma State University (OSU) Center for Health Services","city":"Tulsa","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"UT Southwestern Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elizabeth Dedrick, BS","phone":"469-602-2356","email":"elizabeth.dedrick@utsouthwestern.edu"},{"name":"Shavonna Williams","phone":"469-602-1926","email":"shavonna.williams@utsouthwestern.edu"}],"primaryOutcomes":["Treatment response"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["tirzepatide"],"locationSlugs":["los-angeles-california","san-francisco-california","tulsa-oklahoma","dallas-texas"],"enrichment":{"headline":"Phase 2: testing Tirzepatide for Methamphetamine Use Disorder","inPlainEnglish":"This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial evaluating the tolerability, safety, and preliminary how well it works of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD). The central hypothesis of the proposed research is that tirzepatide is a safe and potentially efficacious treatment of MtUD.","whoItsFor":["Ages 18 Years to 65 Years","be aged 18 to 65 years;","have moderate or severe methamphetamine use disorder;","have active pattern of methamphetamine use;","be interested in reducing or stopping methamphetamine use;","be overweight or obese (body mass index ≥25 kg/m²); and","(only for biological females) agree to use acceptable contraception and undergo urine pregnancy testing unless unable to become pregnant"],"whoShouldSkip":["report using any glucagon like peptide 1 receptor agonists (GLP-1RA, including tirzepatide), sulfonylureas, or insulin in the past 90 days;","have a current eating disorder or severe alcohol or substance use disorder;","have personal or family history of medullary thyroid carcinoma, history of multiple endocrine neoplasia type 2, or hypersensitivity, angioedema, or anaphylaxis to GLP-1RAs or tirzepatide;","are currently pregnant, breastfeeding, or planning pregnancy;","require psychiatric hospitalization;","have recent suicidal or current homicidal ideation;","are incarcerated or in court-mandated residential placement;"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Placebo (saline). The registry lists allocation as randomized. This is a phase 2, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, parallel-group trial evaluating the tolerability, safety, and preliminary how well it works of tirzepatide for the treatment of individuals with moderate or severe methamphetamine use disorder (MtUD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 228 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.023Z"},{"nctId":"NCT07826429","title":"Evaluation of the F&P Mask, US, 2026","officialTitle":"Evaluation of the F&P PAP Mask, US, 2026","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Fisher and Paykel Healthcare","sponsorClass":"INDUSTRY","summary":"This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\\&P PAP mask in a home environment.","conditions":["Chronic Respiratory Conditions","Obstructive Sleep Apnea (OSA)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"F&P Licorice Mask"}],"enrollment":45,"startDate":"2026-09-28","completionDate":"2027-04-21","sex":"ALL","minAge":"22 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Are ≥22 years of age\n* Weigh ≥66 pounds\n* Have been prescribed PAP/NIV therapy by a physician\n* Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation\\*\n* Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation\n* Are fluent in spoken and written English\n* Possess the capacity to provide informed consent\n\nExclusion Criteria:\n\n* Are intolerant to PAP/NIV therapy\n* Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate\n* Are required to use PAP/NIV therapy for \\>12 hours per day or for extensive periods, not including sleep or naps\n* Are trying to get pregnant, are pregnant, or think they may be pregnant\n* Have an IPAP pressure of \\>30 cmH2O if on BPAP\n* Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2\n* Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site\n* Have a history of light-induced seizures (for optional anthropometric scan only)","locations":[{"facility":"Clayton Sleep Institute","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Research Scientist","phone":"+6421436485","email":"cpap.trial@fphcare.co.nz"}],"primaryOutcomes":["Therapeutic Efficacy","Epworth Sleepiness Scale","Patient and Clinical Global Impression (PGI/CGI)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: F&P Licorice Mask for Chronic Respiratory Conditions","inPlainEnglish":"This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\\&P PAP mask in a home environment.","whoItsFor":["Ages 22 Years to any","Are ≥22 years of age","Have been prescribed PAP/NIV therapy by a physician","Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation\\*","Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation","Are fluent in spoken and written English"],"whoShouldSkip":["Are intolerant to PAP/NIV therapy","Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate","Are required to use PAP/NIV therapy for \\>12 hours per day or for extensive periods, not including sleep or naps","Are trying to get pregnant, are pregnant, or think they may be pregnant","Have an IPAP pressure of \\>30 cmH2O if on BPAP","Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2","Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site"],"whatHappens":"If you join, the listed intervention(s) are F&P Licorice Mask. The registry lists allocation as na. This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\\&P PAP mask in a home environment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at St Louis. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.950Z"},{"nctId":"NCT07827586","title":"Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis","officialTitle":"A Prospective Longitudinal Multicenter, Multi-Country, Observational Study Assessing Patient Satisfaction After Subcutaneous Ocrelizumab Administration in Persons With Relapsing-Remitting Multiple Sclerosis (SONATA-MS)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-naive, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c. ocrelizumab.","conditions":["Relapsing-Remitting Multiple Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ocrelizumab"}],"enrollment":1800,"startDate":"2026-09-23","completionDate":"2029-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions).\n* Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information.\n* The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation.\n* Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable.\n\nExclusion Criteria:\n\n* Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment.\n* Prior treatment with rituximab.\n* Contraindications to ocrelizumab as per the local prescribing information.\n* Severe psychiatric or cognitive impairment that, in the opinion of the treating physician, would preclude informed consent, reliable participation in the study, or completion of patient-reported outcomes.\n* Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results.\n* For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available.","locations":[{"facility":"Nemocnice Pardubickeho kraje, a.s., Pardubicka nemocnice","city":"Pardubice","state":"Pardubice Region","country":"Czechia","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Medical Centre","city":"Ljubljana","state":"","country":"Slovenia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: MN46738 https://forpatients.roche.com/ No attachments to email below.","phone":"888-662-6728","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Proportion of Satisfied/Very Satisfied Responses on the Treatment Administration Satisfaction Questionnaire (TASQ) - Satisfaction Item Score at Month 12"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab"],"locationSlugs":["pardubice-czechia","ljubljana-slovenia"],"enrichment":{"headline":"Not a traditional drug phase: testing Ocrelizumab for Relapsing-Remitting Multiple Sclerosis","inPlainEnglish":"The main purpose of the study is to assess patient-reported satisfaction with subcutaneous (s.c.) ocrelizumab administration in participants with relapsing-remitting multiple sclerosis (RRMS) who are treatment-who have not tried this kind of treatment before, switching from intravenous (i.v.) ocrelizumab to s.c. ocrelizumab, or switching from a prior disease-modifying therapy (DMT) to s.c.","whoItsFor":["Ages 18 Years to any","Diagnosis of RRMS according to the revised McDonald criteria (2017 or 2024 revisions)","Initiation of ocrelizumab s.c in accordance with routine clinical practice and local prescribing information","The decision to initiate ocrelizumab s.c. has been made by the treating physician prior to and independently of study participation","Willingness to complete the patient-reported outcome questionnaire TASQ, where applicable"],"whoShouldSkip":["Participation in any clinical study involving disease modifying therapies for multiple sclerosis during the study period or at the time of enrollment","Prior treatment with rituximab","Contraindications to ocrelizumab as per the local prescribing information","Any condition which, in the opinion of the treating physician, would interfere with participation in the study or the interpretation of study results","For participants participating in a Market Research and Patient Support Program (MAP), inclusion is permitted only when a cross-reference to the unique MAP patient identifier is available"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,800 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.979Z"},{"nctId":"NCT07828002","title":"The GranStone Trial","officialTitle":"Prevention of Kidney Stones Due to Paraffin Oil Induced Granuloma: A Prospective Interventional Study","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Martin Blomberg Jensen","sponsorClass":"OTHER","summary":"This study will investigate whether treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue for cosmetic muscle enlargement.\n\nParaffin disease can lead to chronic inflammation, disturbances in calcium regulation, high blood calcium levels, kidney stones, and impaired kidney function. Previous studies from Herlev-Gentofte Hospital have shown that kidney stones occur in nearly half of affected patients, while approximately one-third develop reduced kidney function. Current treatment primarily consists of high-dose corticosteroids, which can reduce blood calcium levels but cause substantial adverse effects and may not adequately control the underlying disease process.\n\nBoth empagliflozin and losartan are widely used medications with documented kidney-protective effects in other chronic kidney diseases. This randomized clinical trial will evaluate whether either treatment can prevent kidney stone formation and slow kidney-related complications in patients with paraffin disease.\n\nThe purpose of this study is to determine whether treatment with empagliflozin or losartan can prevent kidney stone formation and improve kidney health in patients with paraffin disease.","conditions":["Paraffinoma","Granuloma, Foreign-Body"],"keywords":["Nephrocalcinosis","Nephrolithiasis","Paraffin Oil","Intra-Muscular Oil Injection","Hypercalcemia","Vitamin D","Paraffinoma","Foreign-Body Granuloma"],"interventions":[{"type":"DRUG","name":"empagliflozin (Jardiance) 25 mg"},{"type":"DRUG","name":"Losartan 100 mg"}],"enrollment":100,"startDate":"2026-10-20","completionDate":"2029-03","sex":"MALE","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Signed informed consent by participant\n* Male\n* 18-70 years\n* Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis\n\nExclusion Criteria:\n\n* eGFR \\< 30 ml/min\n* Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial\n* Type 1 DM\n* Known chronic kidney disease in whom RAS-blockade and SGLT2-inhibition is indicated.\n* Severely impaired liver function\n* History of organ transplantation\n* Receiving therapy with an SGLT2 inhibitor or ATII antagonist within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor or ATII antagonist.\n* Known history of angioedema\n* Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the trial, as judged by the investigator","locations":[{"facility":"Division of Translational Endocrinology, Department of Endocrinology and Internal Medicine, Copenhagen University Hospital Herlev, Herlev","city":"Herlev","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Martin B Jensen, Professor","phone":"+4538687318","email":"martin.blomberg.jensen@regionh.dk"},{"name":"Emil B Wriedt, MD","phone":"+4551185797","email":"emil.brink.wriedt@regionh.dk"}],"primaryOutcomes":["Image verified new or increased nephrolithiasis or nephrocalcinosis (from 0-24 months)."],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":["empagliflozin"],"locationSlugs":["herlev-denmark"],"enrichment":{"headline":"Phase 2 / Phase 3: testing empagliflozin (Jardiance) 25 mg for Paraffinoma","inPlainEnglish":"This study will see if treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue for cosmetic muscle enlargement. Paraffin disease can lead to chronic inflammation, disturbances in calcium regulation, high blood calcium levels, kidney stones, and impaired kidney function.","whoItsFor":["Ages 18 Years to 70 Years","Men only","Paraffin granuloma disease with hypercalcemia, hypoparathyroidism, hypercalciuria or a history of nephrolithiasis"],"whoShouldSkip":["Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial","Known chronic kidney disease in whom RAS-blockade and SGLT2-inhibition is indicated","Severely impaired liver function","History of organ transplantation","Receiving therapy with an SGLT2 inhibitor or ATII antagonist within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor or ATII antagonist","Known history of angioedema","Mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the trial, as judged by the investigator"],"whatHappens":"If you join, the listed intervention(s) are empagliflozin (Jardiance) 25 mg, or Losartan 100 mg. The registry lists allocation as randomized. This study will see if treatment with empagliflozin or losartan can reduce the risk of kidney stone formation in patients with paraffin disease, a condition caused by the injection of paraffin oil into muscle tissue for cosmetic muscle enlargement.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 100 people at Herlev. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.604Z"},{"nctId":"NCT07828236","title":"Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma","officialTitle":"Phase 1, Open-Label, First-In-Human Trial of Intraperitoneal Lm-LLO-TT And Gemcitabine in Participants With Unresectable Pancreatic Ductal Adenocarcinoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Loki Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"ClinicalTrials.gov Brief Summary\n\nThis Phase 1, open-label, first-in-human study is designed to evaluate the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Up to 18 participants will be enrolled.\n\nLm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen. The study will assess the safety of administering Lm-LLO-TT directly into the peritoneal cavity and characterize its use in combination with low-dose gemcitabine.\n\nEligible participants will receive a tetanus toxoid booster vaccination during screening and undergo placement of an intraperitoneal access port before treatment. Participants will receive a single loading dose of Lm-LLO-TT followed by five cycles of low-dose gemcitabine and low-dose Lm-LLO-TT administered over approximately 17 days. Participants will be monitored for adverse events, laboratory abnormalities, dose-limiting toxicities, and disease outcomes throughout the study.\n\nThe primary objective is to assess safety and tolerability and to determine the maximum tolerated dose and recommended dose for future clinical studies. Secondary objectives include evaluation of anti-tumor activity. Exploratory objectives include assessment of immune biomarkers, changes in pancreatic cancer-related symptoms, and changes in pain medication use.\n\nParticipants will undergo tumor imaging assessments following treatment and during follow-up. A post-treatment tumor biopsy will be required for the first 10 enrolled participants and optional for subsequent participants. Participants will be followed for safety, disease status, and survival for up to 6 months after treatment initiation.","conditions":["Pancreas Cancer, Duct Cell Adenocarcinoma","Pancreatic Cancer","Advanced Pancreatic Adenocarcinoma"],"keywords":["Unresectable Pancreatic Cancer","cancer immunotherapy","Lm-LLO-TT","tetanus toxoid","Listeria","Gemcitabine","Memory T-cells","Listeria monocytogenes Immunotherapy"],"interventions":[{"type":"BIOLOGICAL","name":"Lm-LLO-TT"}],"enrollment":18,"startDate":"2026-10-15","completionDate":"2028-10-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nAble and willing to provide written informed consent. Adults aged 18 years or older. Histologically confirmed pancreatic ductal adenocarcinoma (PDAC) with measurable disease per RECIST v1.1.\n\nPreviously treated with at least one line of chemotherapy for metastatic or unresectable disease, including a fluoropyrimidine-based or gemcitabine-based regimen, or have a contraindication to these therapies.\n\nNo radiation therapy, targeted therapy, or chemotherapy within 14 days prior to first study treatment; no immunotherapy or biologic therapy within 28 days prior to first study treatment.\n\nRecovery to ≤ Grade 2 from clinically significant toxicities of prior therapy. ECOG Performance Status 0-2. Estimated life expectancy greater than 3 months. Adequate organ function, including adequate hematologic, hepatic, and renal function.\n\nParticipants with treated brain metastases may be enrolled if clinically stable for at least 1 month.\n\nWilling to comply with study procedures and contraceptive requirements. Participants with HIV may be enrolled if receiving antiretroviral therapy and CD4 count is \\>400 cells/µL.\n\nParticipants with hepatitis B may be enrolled if viral load is undetectable and appropriately treated; participants with hepatitis C may be enrolled following curative treatment.\n\nDemonstrated tetanus toxoid (TT) immune responsiveness, either at baseline or following administration of a tetanus toxoid booster during screening.\n\nExclusion Criteria:\n\n* History of chronic comorbidities that would significantly limit participation in the study, including severe heart failure (NYHA Class III-IV), end-stage renal disease, substance dependence, or inadequate venous access, as determined by the investigator.\n\nCandidate for curative-intent surgical resection.\n\nSurgery within 2 weeks prior to first study treatment.\n\nEvidence of hepatic cirrhosis or clinically/radiographically significant ascites.\n\nBlood transfusion within 14 days prior to study treatment or requirement for frequent blood transfusions (\\>2 per month).\n\nTreatment with systemically active corticosteroids within 28 days before study treatment (except low-dose dexamethasone ≤2 mg/day or prednisone ≤10 mg/day).\n\nSystemic antibiotic therapy within 14 days prior to first dose of Lm-LLO-TT.\n\nReceipt of another investigational product or vaccine within 28 days prior to first study treatment.\n\nReceipt of any vaccine other than the protocol-required tetanus toxoid booster within 4 weeks before study treatment or during the initial DLT evaluation period.\n\nMajor surgery, significant traumatic injury, unhealed surgical wounds, or planned surgery requiring general anesthesia within 28 days before study treatment.\n\nActive, uncontrolled HIV, hepatitis B, hepatitis C, or HTLV-1 infection, or CD4 count \\<400 cells/µL.\n\nPresence of implanted prosthetic devices, including orthopedic prostheses, pacemakers, or prosthetic heart valves.\n\nChronic immunosuppressive therapy for autoimmune or rheumatologic conditions.\n\nPregnant or breastfeeding individuals.\n\nActive uncontrolled bacterial infection requiring intravenous antibiotics, fever \\>38.1°C, or unexplained fever within 7 days before Day 1.\n\nHistory of Guillain-Barré syndrome within 6 weeks of a previous tetanus toxoid vaccination or prior Arthus-type hypersensitivity reaction to tetanus vaccine.","locations":[{"facility":"Einstein College of Medicine/Montefiore Hospital","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Corrina Pavetto, Clinical Operations Director","phone":"2023215786","email":"cpavetto@clinregconsults.com"}],"primaryOutcomes":["Safety and tolerability"],"hasResults":false,"conditionSlugs":["pancreatic-cancer","als"],"drugSlugs":[],"locationSlugs":["the-bronx-new-york"],"enrichment":{"headline":"Phase 1: testing Lm-LLO-TT for Pancreas Cancer, Duct Cell Adenocarcinoma","inPlainEnglish":"ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to measure the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC). Lm-LLO-TT is a live attenuated Listeria monocytogenes-based immunotherapy engineered to express a tetanus toxoid antigen.","whoItsFor":["Ages 18 Years to any","Previously treated with at least one line of chemotherapy for metastatic or unresectable disease, including a fluoropyrimidine-based or gemcitabine-based regimen, or have a contraindication to these therapies","No radiation therapy, targeted therapy, or chemotherapy within 14 days prior to first study treatment; no immunotherapy or biologic therapy within 28 days prior to first study treatment","Recovery to ≤ Grade 2 from clinically significant toxicities of prior therapy. how well you can do daily activities (ECOG score) 0-2. Estimated life expectancy greater than 3 months. Adequate organ function, including adequate hematologic, hepatic, and renal function","Participants with treated brain metastases may be enrolled if clinically stable for at least 1 month","Participants with hepatitis B may be enrolled if viral load is undetectable and appropriately treated; participants with hepatitis C may be enrolled following curative treatment","Demonstrated tetanus toxoid (TT) immune responsiveness, either at baseline or following administration of a tetanus toxoid booster during screening"],"whoShouldSkip":["History of chronic comorbidities that would significantly limit participation in the study, including severe heart failure (NYHA Class III-IV), end-stage renal disease, substance dependence, or inadequate venous access, as determined by the investigator","Candidate for curative-intent surgical resection","Surgery within 2 weeks prior to first study treatment","Evidence of hepatic cirrhosis or clinically/radiographically significant ascites","Blood transfusion within 14 days prior to study treatment or requirement for frequent blood transfusions (\\>2 per month)","Treatment with systemically active corticosteroids within 28 days before study treatment (except low-dose dexamethasone ≤2 mg/day or prednisone ≤10 mg/day)","Systemic antibiotic therapy within 14 days prior to first dose of Lm-LLO-TT"],"whatHappens":"If you join, the listed intervention(s) are Lm-LLO-TT. The registry lists allocation as randomized. ClinicalTrials.gov Brief Summary This Phase 1, open-label, first-in-human study is designed to measure the safety, tolerability, and recommended dose of intraperitoneal (IP) administration of Lm-LLO-TT in combination with low-dose gemcitabine in adults with previously treated, unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 18 people at The Bronx. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.452Z"},{"nctId":"NCT07829185","title":"Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer","officialTitle":"Modified FOLFIRINOX and Pentamidine as First-line Treatment in Advanced and Metastatic Pancreatic Ductal Adenocarcinoma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Oklahoma","sponsorClass":"OTHER","summary":"The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.","conditions":["Pancreatic Ductal Adenocarcinoma (PDAC)"],"keywords":["modified FOLFIRINOX","Pentamidine","Advanced","Metastatic"],"interventions":[{"type":"DRUG","name":"modified FOLFIRINOX"},{"type":"DRUG","name":"Pentamidine 300 MG Injection"}],"enrollment":30,"startDate":"2026-10-06","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent signed and dated by the patient\n* At least 18 years-of-age at the time of signature of the informed consent form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1\n* Patients with a confirmed diagnosis of locally advanced, unresectable and/or metastatic pancreatic cancer\n* Patients must have at least one measurable disease per RECIST v1.1,\n* Patients must have at least 1 tumor lesion amenable to biopsy and must be willing to undergo a biopsy prior to first treatment and after receiving 8th cycle of therapy.\n* Adequate bone marrow function defined as ANC\\> 1000/μL and platelets\\>75,000/μL\n* Adequate liver function defined as total bilirubin\\<1.5g/L\n* Adequate renal function defined as creatinine \\<1.5ULN or creatinine clearance greater than 30 ml/m2.\n* AST and ALT \\<2.5x ULN or AST and ALT\\<5xULN if liver function abnormalities are due to liver metastases\n* Male or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following the last dose. Male patients must also refrain from donating sperm during their participation in the study.\n* Life expectancy ≥ 3 months according to the Investigator's judgment.\n\nExclusion Criteria:\n\n* Any systemic anti-cancer chemotherapy, small molecule, biologic, or from a previous treatment regimen or clinical study in a metastatic setting before the first dose of study drug.\n* Active bacterial infection\n* Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment\n* Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment\n* Any of the following cardiac criteria currently or within the last 6 months:\n\n  1. Mean resting corrected QT interval (QTc) \\>480 msec\n  2. Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block\n  3. Congestive heart failure (New York Heart Association ≥ Grade 2\n  4. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age, or any concomitant medication known to prolong the QT interval\n* Incidences of chronic hypokalemia that cannot be corrected.\n* As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection requiring treatment including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.\n* Presence of other active invasive cancers other than the one treated in this study within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ carcinoma of uterine cervix, or other local tumors considered cured by local treatment\n* Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.\n* Prisoners","locations":[{"facility":"University of Oklahoma Health Campus","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marisha Williams","phone":"572-244-0111","email":"SCC-IIT-Office@ouhsc.edu"},{"name":"Lead Nurse","phone":"572-244-0111","email":"SCC-IIT-Office@ouhsc.edu"}],"primaryOutcomes":["Number and proportion of patients with Grade 3 and higher adverse events deemed related to pentamidine during trial treatment, using CTCAE v.6.0."],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["oklahoma-city-oklahoma"],"enrichment":{"headline":"Phase 1: testing modified FOLFIRINOX for Pancreatic Ductal Adenocarcinoma (PDAC)","inPlainEnglish":"The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1","Patients with a confirmed diagnosis of locally advanced, unresectable and/or metastatic pancreatic cancer","Patients must have at least one measurable disease per RECIST v1.1,","Patients must have at least 1 tumor lesion amenable to biopsy and must be willing to undergo a biopsy prior to first treatment and after receiving 8th cycle of therapy","Adequate bone marrow function defined as ANC\\> 1000/μL and platelets\\>75,000/μL","Adequate liver function defined as total bilirubin\\<1.5g/L","Adequate renal function defined as creatinine \\<1.5ULN or creatinine clearance greater than 30 ml/m2"],"whoShouldSkip":["Any systemic anti-cancer chemotherapy, small molecule, biologic, or from a previous treatment regimen or clinical study in a metastatic setting before the first dose of study drug","Active bacterial infection","Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least 6 months after the last administration of study treatment","Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment","Any of the following cardiac criteria currently or within the last 6 months:","Mean resting corrected QT interval (QTc) \\>480 msec","Any clinically important abnormalities (as assessed by the Investigator) in rhythm, conduction, or morphology of resting electrocardiograms (ECGs), e.g., complete left bundle branch block, third degree heart block"],"whatHappens":"If you join, the listed intervention(s) are modified FOLFIRINOX, or Pentamidine 300 MG Injection. The registry lists allocation as randomized. The purpose of this research is to observe the effects of using a new combination of drugs to inhibit tumor growth.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Oklahoma City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.444Z"},{"nctId":"NCT07829497","title":"Pain Phenotyping of Rheumatic Diseases - An Observational Study","officialTitle":"Pain Phenotyping of Rheumatic Diseases - An Observational Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","sponsorClass":"NIH","summary":"Background:\n\nRheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain. This can lead to ongoing pain that interferes with daily life. Researchers want to know more about how pain affects the lives of those with rheumatic diseases.\n\nObjective:\n\nTo learn how the body and brain experience pain in people with and without rheumatic diseases.\n\nEligibility:\n\nPeople aged 9 to 85 years with a diagnosed or suspected rheumatic disease and ongoing pain. They must be enrolled in protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223. Healthy volunteers are also needed.\n\nDesign:\n\nAll participants will have an initial visit and may have up to 5 follow-up clinic visits spaced about 6 months apart. Each visit may last 3 to 4 hours. Patients with rheumatic diseases may have up to 2 more visits if they have a disease flare-up.\n\nAll participants will have these procedures at each visit:\n\nBedside quantitative sensory testing (B-QST): The participant's body will be touched with various probes: a cotton tip, a tuning fork, an ice-cold tuning fork, a heat probe, a device that applies pressure, and a probe with a sharp tip. These probes will not cause injury. Participants will describe how the touches feel and rate the intensity on a scale of 1 to 10.\n\nQuestionnaires: They will rate their overall health, quality of life, and any disease activity.\n\nResearch blood: Blood will be collected during the visits. Some blood will be used for how environmental factors affect our genes.\n\nPhysical exam and History review: They will provide information about their medical history and physical exam will be performed by a clinician.","conditions":["Rheumatic Diseases","Lupus Erythematosus, Systemic","Lupus Vasculitis, Central Nervous System","Arthritis","Spondylarthritis","Ankylosing Spondylarthritis","Rheumatoid Arthritis","Sjogren's Syndrome"],"keywords":["Pain Phenotyping","Rheumatic Diseases","Observational Study"],"interventions":[{"type":"DEVICE","name":"Bedside quantitative sensory testing"}],"enrollment":225,"startDate":"2026-11-16","completionDate":"2033-06-15","sex":"ALL","minAge":"9 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"* INCLUSION CRITERIA\n\nInclusion Criteria for Subjects Suspected or Diagnosed with Rheumatic Diseases\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 9-85 years\n3. Diagnosed or suspected of having a rheumatic disease.\n4. Ability of the subject to understand and the willingness to sign a written informed consent document or assent.\n5. Must be enrolled in one of the NIAMS protocols (01-AR-0227, 94-AR-0066, 11-AR-0223)\n6. To be able to answer PRO questionnaires in either English and/or Spanish languages.\n\nInclusion Criteria Healthy Volunteers\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Aged 9-85 years\n3. No known history of a rheumatic disease or any other chronic medical illness.\n4. Ability of the subject to understand and the willingness to sign a written informed consent document or assent.\n5. To be enrolled in either of the ongoing NIAMS protocols 01-AR-0227, 94-AR-0066, or 11-AR-0223.\n6. To be able to answer PRO questionnaires in either English and/or Spanish languages.\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Treatment with investigational drug or other investigational intervention while enrolled in this study.\n2. Any physical exam finding that precludes bedside QST.\n3. Developmental delay or cognitive impairment that interfere with following or understanding the test instructions.\n4. Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded.\n5. Any chronic medical condition that may hinder participation in the study as determined by the study PI.","locations":[{"facility":"National Institutes of Health Clinical Center","city":"Bethesda","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lubna K Hooda, R.N.","phone":"(301) 480-1391","email":"lubna.hooda@nih.gov"},{"name":"Sarfaraz A Hasni, M.D.","phone":"(301) 451-1599","email":"hasnisa@mail.nih.gov"}],"primaryOutcomes":["Pain phenotype based on measurements from PRO's and bedside quantitative sensory testing (QST)."],"hasResults":false,"conditionSlugs":["als","rheumatoid-arthritis","lupus"],"drugSlugs":[],"locationSlugs":["bethesda-maryland"],"enrichment":{"headline":"Not a traditional drug phase: Bedside quantitative sensory testing for Rheumatic Diseases","inPlainEnglish":"Background: Rheumatic diseases can affect the joints, ligaments, tendons, bones, muscles, and skin. They can also cause inflammation, damage body tissues, and change nerve signals in the brain.","whoItsFor":["Ages 9 Years to 85 Years","who can join for Subjects Suspected or Diagnosed with Rheumatic Diseases","In order to be eligible to participate in this study, an individual must meet all of the following criteria:","Stated willingness to comply with all study procedures and availability for the duration of the study","Diagnosed or suspected of having a rheumatic disease","Must be enrolled in one of the NIAMS protocols (01-AR-0227, 94-AR-0066, 11-AR-0223)","To be able to answer PRO questionnaires in either English and/or Spanish languages","who can join Healthy Volunteers"],"whoShouldSkip":["An individual who meets any of the following criteria will be excluded from participation in this study:","Treatment with investigational drug or other investigational intervention while enrolled in this study","Any physical exam finding that precludes bedside QST","Developmental delay or cognitive impairment that interfere with following or understanding the test instructions","Subjects using illicit or street drugs will be excluded. Subjects taking prescribed pain medications will not be excluded","Any chronic medical condition that may hinder participation in the study as determined by the study PI"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 225 people at Bethesda. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.952Z"},{"nctId":"NCT07829783","title":"A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)","officialTitle":"A Phase 3 Study Evaluating Sacituzumab Tirumotecan Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) as Induction Therapy, Followed by Local Therapy With Chemoradiation and MK-3475A Consolidation Versus Local Therapy With Chemoradiation in Participants With MIBC Who Elect Bladder Preservation","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.\n\nThe usual treatment for MIBC is surgery to remove the bladder but some people choose to have other treatments, such as chemoradiotherapy (CRT), instead of surgery so they can keep their bladder.\n\nResearchers want to know if giving 2 trial treatments with CRT can treat MIBC. One trial treatment is called sacituzumab tirumotecan (sac-TMT) and the other trial treatment is called subcutaneous (SC) pembrolizumab (or pembrolizumab and berahyaluronidase alfa). The main goal of this trial is to learn if participants who receive sac-TMT, SC pembrolizumab, and CRT live longer without their cancer growing, spreading, or coming back compared to those who receive CRT alone.","conditions":["Bladder Cancer"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"Sac-TMT"},{"type":"BIOLOGICAL","name":"Pembrolizumab and Berahyaluronidase alfa"},{"type":"DRUG","name":"Cisplatin"},{"type":"DRUG","name":"5-FU"},{"type":"DRUG","name":"MMC"},{"type":"DRUG","name":"Capecitabine"},{"type":"DRUG","name":"Gemcitabine"},{"type":"RADIATION","name":"Conventional Radiotherapy"},{"type":"RADIATION","name":"Hypofractionated radiotherapy"},{"type":"DRUG","name":"Rescue Medications"}],"enrollment":400,"startDate":"2026-10-23","completionDate":"2031-11-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)\n* Has clinically nonmetastatic bladder cancer (N0-N1M0)\n* Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has known presence of diffuse carcinoma in situ (CIS) throughout the bladder\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has received prior pelvic/local radiation therapy for any reason or any systemic antineoplastic treatment for MIBC\n* Has not recovered to Grade ≤1 or baseline from AE associated with anticancer therapy before randomization\n* Has a known additional malignancy that is progressing or has required active treatment within the past 2 years\n* Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/interstitial lung disease, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments","locations":[{"facility":"Chang Gung Memorial Hospital at Kaohsiung ( Site 2702)","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"MNPE ClinCenter of Oncology,Hematology,Transplantology and Palliative Care of CherkasyRegCouncil ( Site 3004)","city":"Cherkasy","state":"Cherkasy Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Communal non-profit enterprise \"Regional clinical hospital of Ivano-Frankivsk Regional Council\" ( Site 3000)","city":"Ivano-Frankivsk","state":"Ivano-Frankivsk Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Limited Liability Company Ukrainian Center of Tomotherapy ( Site 3008)","city":"Kropyvnytskyi","state":"Kirovohrad Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital of the State Nonprofit Company \"Danylo Halytsky Lviv National Medical University ( Site 3002)","city":"Lviv","state":"Lviv Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"MNPE Lviv Oncology Regional Treatment and Diagnostic Center of Lviv Regional Council ( Site 3005)","city":"Lviv","state":"Lviv Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 3010)","city":"Rivne","state":"Rivne Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal Enterprise \"Volyn Regional Medical Oncology Centre\" of the Volyn Regional Council ( Site 3007)","city":"Lutsk","state":"Volyn Oblast","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Municipal non-profit enterprise \"Kyiv City Clinical Oncology Center\" of executive body of Kyiv City ( Site 3006)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shalimov Institute of Surgery and Transplantation ( Site 3009)","city":"Kyiv","state":"","country":"Ukraine","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@merck.com"}],"primaryOutcomes":["Event-Free Survival (EFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["kaohsiung-city-taiwan","cherkasy-ukraine","ivano-frankivsk-ukraine","kropyvnytskyi-ukraine","lviv-ukraine","rivne-ukraine","lutsk-ukraine","kyiv-ukraine"],"enrichment":{"headline":"Phase 3: testing Sac-TMT for Bladder Cancer","inPlainEnglish":"Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC). MIBC is a type of bladder cancer that has spread into the muscle layer of the bladder but has not spread to other distant parts of the body.","whoItsFor":["Ages 18 Years to any","The main who can join include but are not limited to the following:","Has a diagnosis of muscle-invasive bladder cancer (MIBC) (cT2-T4aN0-N1)","Has clinically nonmetastatic bladder cancer (N0-N1M0)","Is either ineligible for radical cystectomy or has opted for bladder preservation and is planned to receive chemoradiotherapy (CRT)","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Sac-TMT, Pembrolizumab and Berahyaluronidase alfa, or Cisplatin. The registry lists allocation as randomized. Researchers are looking for new ways to treat muscle-invasive bladder cancer (MIBC).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 400 people at 10 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.291Z"},{"nctId":"NCT07830329","title":"Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity","officialTitle":"A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 52-Week Trial to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1/GIP Receptor Agonist, in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test an experimental Regeneron drug called olatorepatide (\"study drug\") to see if it can help treat Hidradenitis Suppurativa (HS).\n\nIn this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.\n\nThe study is looking at:\n\n* What side effects olatorepatide might cause\n* How well olatorepatide works\n* How much olatorepatide is in the blood at different times\n* If the body makes antibodies to olatorepatide, which may cause olatorepatide to not work as well","conditions":["Hidradenitis Suppurativa"],"keywords":["Acne inversa","Skin problems","Inflammatory skin lesions","Painful nodules and abscesses","HS inflammatory nodules","Abscesses","Overweight or obesity","Weight loss"],"interventions":[{"type":"DRUG","name":"Olatorepatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":300,"startDate":"2026-10-29","completionDate":"2028-11-24","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Diagnosis of HS based on:\n\n   1. Documented or reported history of HS for ≥6 months prior to baseline visit\n   2. Confirmation of HS by the investigator during physical examination at screening\n2. HS lesions present in at least 2 distinct anatomic areas as described in the protocol\n3. Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)\n4. Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach \\[bath\\], or alternative antiseptic agents in accordance with local/country guidelines) applied to HS-affected areas as described in the protocol\n5. Body Mass Index (BMI) ≥27.0 kg/m2 at screening\n\nKey Exclusion Criteria:\n\n1. Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial\n2. Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol\n3. Current heart failure classified as being in NYHA Class IV at screening\n4. History of chronic pancreatitis or acute pancreatitis\n5. Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening\n6. Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol\n\nNote: Other Protocol Defined Inclusion/ Exclusion Criteria Apply","locations":[{"facility":"Equity Medical, LLC","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Percent change in total Abscess and inflammatory Nodule (AN) count"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["the-bronx-new-york"],"enrichment":{"headline":"Phase 2: testing Olatorepatide for Hidradenitis Suppurativa","inPlainEnglish":"This study will test an experimental Regeneron drug called olatorepatide (\"study drug\") to see if it can help treat Hidradenitis Suppurativa (HS). In this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.","whoItsFor":["Ages 18 Years to any","Diagnosis of HS based on:","Documented or reported history of HS for ≥6 months prior to baseline visit","Confirmation of HS by the investigator during physical examination at screening","HS lesions present in at least 2 distinct anatomic areas as described in the protocol","Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)","Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach \\[bath\\], or alternative antiseptic agents in accordance with local/country guidelines) applied to HS-affected areas as described in the protocol","Body Mass Index (body-mass index (BMI)) ≥27.0 kg/m2 at screening"],"whoShouldSkip":["Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial","Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol","Current heart failure classified as being in NYHA Class IV at screening","History of chronic pancreatitis or acute pancreatitis","Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening","Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol","Note: Other Protocol Defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are Olatorepatide, or Placebo. The registry lists allocation as randomized. This study will test an experimental Regeneron drug called olatorepatide (\"study drug\") to see if it can help treat Hidradenitis Suppurativa (HS).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 300 people at The Bronx. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.825Z"},{"nctId":"NCT07830771","title":"Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis","officialTitle":"Fibroblast Activating Protein (FAP) PET/CT in Adults With Tuberculosis","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis. The Investigators propose to use FAP PET/CT to define the extent and location of FAP signals in lungs of TB patients early in TB treatment and after TB cure. These timepoints are chosen as they could be utilized to deliver treatments designed to prevent, predict, or treat Post-transplant Lymphoproliferative Disorder (PTLD). The overarching hypothesis is that greater FAP signals in lungs of adult TB patients are associated with greater imaging manifestations of PTLD after cure.","conditions":["Tuberculosis, Pulmonary"],"keywords":["pTB","Tuberculosis"],"interventions":[{"type":"DRUG","name":"[18F]-FAPI-74"}],"enrollment":10,"startDate":"2026-09-22","completionDate":"2028-09-30","sex":"ALL","minAge":"21 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Participants will be ≥ 21 years of age\n2. Diagnosed with microbiologically confirmed (culture or Xpert MTB/RIF PCR positive on at least one respiratory sample) pTB\n3. Be currently on or able to initiate standard drug-sensitive pTB treatment according to IDSA guidelines.\n4. Have initiated or planning to initiate TB treatment prior to screening and enrollment.\n5. Have a Timika CXR score indicating cavitary disease\n6. Be able and willing to provide written informed consent to participate in the study\n\nExclusion Criteria\n\n1. Diagnosed with TB that is resistant to rifampin per medical record review or have only extrapulmonary TB.\n2. Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \\[F-18\\]-FAPI-74 injection.\n3. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician\n4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study, including completion of the study follow-up or TB treatment.\n5. History of major alternative pulmonary disease such as asthma, chronic obstructive pulmonary disease (COPD), or interstitial lung disease as per medical record review or patient self-report. \"Major\" is defined as potentially resulting in pulmonary radiographic abnormalities that could interfere with interpretation of PET-CT scan data.\n6. Have been administered at least 7 days of corticosteroids or any duration of another systemic investigational agent within 3 months of enrollment per medical record review or patient self-report\n7. Have symptoms or signs that, in the opinion of the investigative team, are suggestive of active TB at the time of pre-screening per patient self-report","locations":[{"facility":"Perelman School of Medicine, Nuclear Medicine","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mark A Sellmyer, MD","phone":"(215) 573-3212","email":"mark.sellmyer@pennmedicine.upenn.edu"},{"name":"Erin Schubert","phone":"(215) 573-6569","email":"erin.schubert@pennmedicine.upenn.edu"}],"primaryOutcomes":["Determine the relationship between change in FAP PET signals in lungs during TB treatment and change in lung structural damage in adult patients treated for pulmonary TB."],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Early phase 1: testing [18F]-FAPI-74 for Tuberculosis, Pulmonary","inPlainEnglish":"This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis. The Investigators propose to use FAP PET/CT to define the extent and location of FAP signals in lungs of TB patients early in TB treatment and after TB cure.","whoItsFor":["Ages 21 Years to any","you would be ≥ 21 years of age","Diagnosed with microbiologically confirmed (culture or Xpert MTB/RIF PCR positive on at least one respiratory sample) pTB","Be currently on or able to initiate standard drug-sensitive pTB treatment according to IDSA guidelines","Have initiated or planning to initiate TB treatment prior to screening and enrollment","Have a Timika CXR score indicating cavitary disease"],"whoShouldSkip":["Diagnosed with TB that is resistant to rifampin per medical record review or have only extrapulmonary TB","Women of childbearing potential may not be pregnant or breast-feeding. A negative pregnancy test will be required before \\[F-18\\]-FAPI-74 injection","Inability to tolerate imaging procedures in the opinion of an investigator or treating physician","Have been administered at least 7 days of corticosteroids or any duration of another systemic investigational agent within 3 months of enrollment per medical record review or patient self-report","Have symptoms or signs that, in the opinion of the investigative team, are suggestive of active TB at the time of pre-screening per patient self-report"],"whatHappens":"If you join, the listed intervention(s) are [18F]-FAPI-74. The registry lists allocation as na. This is an early phase study in patients with Tuberculosis (TB) to evaluate Fibroblast Activating Protein (FAP) activation as a marker of fibrosis.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 10 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.770Z"},{"nctId":"NCT07832994","title":"Metaboic Syndrome and Fatty Liver in Celiac Disease Females: Reponse to Exercise in Adolescents","officialTitle":"Metaboic Syndrome and Fatty Liver in Celiac Disease Females: Reponse to Exercise in Adolescents","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Cairo University","sponsorClass":"OTHER","summary":"metabolic syndrome and fatty liver is common in adolescents with celiac diseases. exercise may control these cardiovascular risk factors","conditions":["Celiac Disease","Metabolic Syndrome","Non Alcoholic Fatty Liver"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"walking exercise"}],"enrollment":40,"startDate":"2026-08-15","completionDate":"2026-12-15","sex":"FEMALE","minAge":"13 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* celiac disease\n* metabolic syndrome\n* nonalcholic fatty liver\n\nExclusion Criteria:\n\n* cardiac disease\n* renal failure\n* respiratory disease","locations":[{"facility":"Cairo University","city":"Giza","state":"Dokki","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ali MA Ismail, PhD","phone":"+201005154209","email":"ali.mohamed@pt.cu.edu.eg"},{"name":"Fatma mohamed, PhD","phone":"+201033321109","email":"fatmaraed1994@gmail.com"}],"primaryOutcomes":["alanine transamianse"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["giza-egypt"],"enrichment":{"headline":"Not a traditional drug phase: walking exercise for Celiac Disease","inPlainEnglish":"Metabolic syndrome and fatty liver is common in adolescents with celiac diseases. exercise may control these cardiovascular risk factors","whoItsFor":["Ages 13 Years to 17 Years","Women only","nonalcholic fatty liver"],"whoShouldSkip":["respiratory disease"],"whatHappens":"If you join, the listed intervention(s) are walking exercise. The registry lists allocation as randomized. Metabolic syndrome and fatty liver is common in adolescents with celiac diseases.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Giza. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.166Z"},{"nctId":"NCT07833488","title":"Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.","officialTitle":"Imperial Knee Health Cohort: New Exploration of Early-stage Changes Study.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Imperial College London","sponsorClass":"OTHER","summary":"The goal of this observational, non-interventional cohort study is to identify tests or markers in blood or knee fluid, or any genetic risk factors that might contribute to worsening or improvement of knee osteoarthritis.\n\nMales and females aged ≥18 with early-stage knee osteoarthritis, prior proven acute knee injury, or degenerative meniscal tear will be recruited at Imperial College Healthcare NHS Trust. Participants with prior proven acute knee injury must be aged ≤ 50. A single knee per participant will be followed throughout the study; this will be referred to as ''affected knee'', identified at baseline.\n\nThe study involves:\n\n1. Samples collection:\n\n   * From individuals recruited in-person: blood or buccal (cheek) swab and/or knee joint (synovial) fluid - this will be collected during routine NHS visit, if individuals undergo scheduled knee surgery or knee aspiration procedure (Knee aspiration is a procedure to remove excess fluid from the knee joint for diagnosis or treatment).\n   * From individuals recruited remotely: saliva sample.\n2. Clinical data collection at baseline:\n\n   Participants will complete study Core Questionnaire Pack. These are questionnaires asking about participants' knee pain, function, and activity level.\n3. Clinical data collection at yearly remote visits, through years 1-5:\n\n   Participants will complete study Follow-Up Questionnaire Pack, asking about participants' knee pain, function, and activity level - same as at baseline, but additionally participants will be asked about any knee surgeries on the affected knee, since the last study visit.\n4. Imaging data collection at baseline and at Year 2 or Year 3 follow-up visit:\n\nIf at baseline visit X-ray imaging is available as a part of usual NHS care, then participants will only be invited to attend one X-ray appointment at Year 2 or Year 3 follow-up visit.\n\nThe study expect to recruit up to 200 participants with approximately 100 participants having early-stage knee osteoarthritis or degenerative meniscal tear and the remaining participants having prior proven acute knee injury.\n\nIndividuals will be able join the study for between 2-3 years. Follow up visits will last up to 5 years.","conditions":["Knee Osteoarthritis"],"keywords":["post-traumatic knee osteoarthritis","genetics","synovial fluid","protein marker","knee injury","knee"],"interventions":[],"enrollment":200,"startDate":"2026-09-14","completionDate":"2031-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nALL participants must meet the following criteria:\n\n* Male or female, aged ≥18 years of age AND at least one of the following (a-d):\n\n  1. A definite diagnosis of knee osteoarthritis , evidenced by consistent knee symptoms and imaging findings, commensurate with non-advanced KL grade changes (KL 0-2 where an X-ray grade is available)\n  2. A symptomatic degenerative meniscal tear with or without definite imaging findings suggesting knee osteoarthritis\n  3. Probable early-stage symptomatic knee osteoarthritis without definite imaging changes, fulfilling NICE diagnostic criteria for osteoarthritis:\n\n     * Age 45 or over\n     * Activity-related knee pain.\n     * Either no morning stiffness or that lasts \\<30 minutes\n  4. A definite clinically significant acute knee injury at the age of 50 or younger at any stage in the past, evidenced by appropriate clinical history of a traumatic knee episode AND documented imaging or surgical confirmation of a relevant structural injury.\n* Willing to provide at least one of the following samples: synovial fluid or blood (a salivary sample is an acceptable alternative for remote participants with a history of knee injury. This alternative also applies to existing participants from ICHTB/IHKB, for whom no prior DNA sample is currently banked)\n* Understand English sufficiently to be able to read PIS, ICF and/or Participant Invitation Letter\n* Provide an ICF, signed by the participant\n* Be capable of complying with Protocol requirements, i.e. completing study questionnaire packs.\n\nExclusion Criteria:\n\n* Known advanced radiographic changes of KOA on available imaging (KL grade 3-4 where available), or other commensurate findings, such as those present on MRI\n* Knee joint replacement (uni-compartmental arthroplasty or total knee arthroplasty) of the index knee, prior to consent, or planned during current episode of care, or within next 12 months\n* Other clinically significant knee pathology such as infection or malignancy affecting the index knee joint or surrounding bone (at any time)\n* Surgery to the index knee in the last 3 months\n* Any other systemic inflammatory disease (e.g. inflammatory bowel disease), systemic infection, or inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, gout)\n* Systemic/intra-articular steroid use to index knee in the last 3 months\n* Any use of immunosuppressive drugs or chemotherapy in the last 12 months\n* Unwilling or unable to provide follow-up data for minimum 2 years and/or maximum 5 years\n* Pregnancy, expecting to be pregnant, near the scheduled Year 2 or Year 3 X-ray visit.\n* Other medical reason which would prevent participation, at the discretion of the investigator.","locations":[{"facility":"Centre for Inflammatory Disease, 9th Floor, Commonwealth Building, Imperial College London, Department of Immunology and Inflammation, Hammersmith Campus, Du Cane Road, London","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Fiona Watt","phone":"+44 07858 367326","email":"f.watt@imperial.ac.uk"},{"name":"Malgorzata Kochanska","phone":"+44 07858 367326","email":"oaresearchgroup@imperial.ac.uk"}],"primaryOutcomes":["Knee injury and Osteoarthritis Outcome Score (KOOS)"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["london-united-kingdom"],"enrichment":{"headline":"Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those Wi…","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required), non-treatment cohort study is to identify tests or markers in blood or knee fluid, or any genetic risk factors that might contribute to worsening or improvement of knee osteoarthritis. Males and females aged ≥18 with early-stage knee osteoarthritis, prior proven acute knee injury, or degenerative meniscal tear will be recruited at Imperial College Healthcare NHS Trust.","whoItsFor":["Ages 18 Years to any","ALL participants must meet the following criteria:","Male or female, aged ≥18 years of age AND at least one of the following (a-d):","A definite diagnosis of knee osteoarthritis , evidenced by consistent knee symptoms and imaging findings, commensurate with non-advanced KL grade changes (KL 0-2 where an X-ray grade is available)","A symptomatic degenerative meniscal tear with or without definite imaging findings suggesting knee osteoarthritis","Probable early-stage symptomatic knee osteoarthritis without definite imaging changes, fulfilling NICE diagnostic criteria for osteoarthritis:","Activity-related knee pain","Either no morning stiffness or that lasts \\<30 minutes"],"whoShouldSkip":["Known advanced radiographic changes of KOA on available imaging (KL grade 3-4 where available), or other commensurate findings, such as those present on MRI","Knee joint replacement (uni-compartmental arthroplasty or total knee arthroplasty) of the index knee, prior to consent, or planned during current episode of care, or within next 12 months","Other clinically significant knee pathology such as infection or malignancy affecting the index knee joint or surrounding bone (at any time)","Surgery to the index knee in the last 3 months","Any other systemic inflammatory disease (e.g. inflammatory bowel disease), systemic infection, or inflammatory arthritis (e.g. rheumatoid arthritis, psoriatic arthritis, gout)","Systemic/intra-articular steroid use to index knee in the last 3 months","Any use of immunosuppressive drugs or chemotherapy in the last 12 months"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at London. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.506Z"},{"nctId":"NCT07834684","title":"Singula Phase 0.1 Primary Care Pilot","officialTitle":"Validation of an Artificial Intelligence (AI)-Powered Clinical Decision Support System for Anxiety and Depression in Primary Care Settings","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Singula Health, Inc.","sponsorClass":"INDUSTRY","summary":"This prospective, single-arm, observational pilot study evaluates a clinical decision support system developed by Singula Health for use in primary care. Adult patients complete a self-report assessment before a routine primary care visit. The system uses the responses to generate a clinician-facing Companion Brief that summarizes relevant information for the treating clinician. Each Companion Brief is reviewed by the Principal Investigator before it is provided to the clinician. The study will evaluate whether the system can reliably generate and deliver the Companion Briefs, whether clinicians find the Briefs useful and acceptable, and whether patients can successfully complete and accept the pre-visit assessment.","conditions":["Depression - Major Depressive Disorder","Anxiety"],"keywords":["Clinical Decision Support System","Artificial Intelligence","Primary Care","Mental Health Screening","Companion Brief","Patient Health Questionnaire-9 (PHQ-9)","Generalized Anxiety Disorder-7 (GAD-7)"],"interventions":[],"enrollment":100,"startDate":"2026-07-13","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult, aged 18 years or older at the time of consent.\n* Scheduled for a routine, non-urgent primary care visit at a participating practice.\n* Able to read and understand English at a level sufficient to complete the electronic informed consent and Survey 0.1 independently.\n* Has personal-device access to complete the survey (smartphone, tablet, or computer with internet).\n* Capable of providing informed consent.\n\nExclusion Criteria:\n\n* Non-English-speaking, defined as inability to read English at a level sufficient to complete electronic informed consent and the survey independently.\n* Visually impaired to a degree that prevents independent reading of an electronic consent form on a personal device, without specialized assistive technology beyond standard mobile-device accessibility features.\n* Unable to read for any reason (literacy, cognitive impairment, or other).\n* Presenting with an acute psychiatric emergency or in acute crisis at the time of the scheduled visit, as identified by clinic staff during routine check-in.\n* Patient is a known minor at the time of scheduling (under 18 years).\n* Patient or clinician declines participation.","locations":[{"facility":"Morris Medical Office","city":"Brentwood","state":"New York","country":"United States","status":"COMPLETED","lat":null,"lon":null},{"facility":"WestDocs Concierge","city":"Mount Kisco","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marc S Lener, MD","phone":"(240) 389-2381","email":"marc.lener@singulahealth.com"}],"primaryOutcomes":["Successful Production and Delivery of the Companion Brief","Clinician-Rated Overall Clinical Utility of the Companion Brief"],"hasResults":false,"conditionSlugs":["depression","anxiety"],"drugSlugs":[],"locationSlugs":["brentwood-new-york","mount-kisco-new-york"],"enrichment":{"headline":"Singula Phase 0.1 Primary Care Pilot","inPlainEnglish":"This prospective, single-arm, watch-and-measure (no experimental treatment required) pilot study evaluates a clinical decision support system developed by Singula Health for use in primary care. Adult patients complete a self-report assessment before a routine primary care visit.","whoItsFor":["Ages 18 Years to any","Adult, aged 18 years or older at the time of consent","Scheduled for a routine, non-urgent primary care visit at a participating practice","Has personal-device access to complete the survey (smartphone, tablet, or computer with internet)"],"whoShouldSkip":["Visually impaired to a degree that prevents independent reading of an electronic consent form on a personal device, without specialized assistive technology beyond standard mobile-device accessibility features","Unable to read for any reason (literacy, cognitive impairment, or other)","Presenting with an acute psychiatric emergency or in acute crisis at the time of the scheduled visit, as identified by clinic staff during routine check-in","Patient is a known minor at the time of scheduling (under 18 years)","Patient or clinician declines participation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.354Z"},{"nctId":"NCT07835360","title":"Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes","officialTitle":"Cambios en la composición Corporal Tras el Inicio de Agonistas Del Receptor de GLP-1 (GLP-1RA) en Adultos Con Obesidad o Diabetes Tipo 2: Cohorte Prospectiva multicéntrica en Vida Real","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","sponsorClass":"OTHER","summary":"Researchers want to understand what happens to muscle and fat in the body after adults with obesity and/or type 2 diabetes start taking a GLP-1 receptor agonist medication (GLP-1RA), a type of drug already approved and commonly prescribed for weight loss and blood sugar control. This is not a drug trial. No experimental medication will be given. Instead, the study will follow people who are already starting this treatment or having their dose adjusted, as part of their regular medical care, and it will not change or interfere with any decision made by the participant's own doctor.\n\nThese medications help people lose weight, but not all weight loss is the same. Some of it can come from muscle instead of fat, and losing muscle can affect strength and daily function over time. This study will use a scan called DXA (dual-energy X-ray absorptiometry.) to measure how much muscle and fat change over about one year, along with tests of grip strength, walking speed, and everyday physical performance.\n\nAbout 168 adults will take part at two centers in Mexico: the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán in Mexico City and the Instituto de Diabetes, Obesidad y Nutrición in Cuernavaca. After an initial visit, participants will have a phone check-in at 12 weeks and follow-up visits at 24 and 52 weeks, including blood tests, body measurements, and short questionnaires about diet, physical activity, and muscle health. Some participants may also choose to give an extra blood sample for optional genetic testing; this is voluntary and does not affect participation in the main study.\n\nThere is no placebo, randomization, cost, or payment involved. All treatment decisions remain with the participant's own physician. By observing these changes under real-world conditions, the study aims to help doctors better protect muscle while patients lose fat during treatment with these medications.","conditions":["Obesity (Disorder)","Type 2 Diabetes Mellitus"],"keywords":["GLP-1 receptor agonists","Body composition","Appendicular lean mass","DXA","Real-world evidence","Muscle strength","Visceral adipose tissue","Tirzepatide"],"interventions":[],"enrollment":200,"startDate":"2026-07-10","completionDate":"2029-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Agrees to participate in the study by signing informed consent\n2. Age 18 years or older\n3. Diagnosis of obesity and/or type 2 diabetes mellitus, documented in the clinical record\n4. Receiving, on indication of the treating physician and as part of routine clinical care, a therapy with activity on the GLP-1 receptor, including a) GLP-1 receptor monoagonists, b) dual GIP/GLP-1 coagonists, or c) other multiple coagonists with activity on the GLP-1 receptor holding current health authorization for clinical use in Mexico\n5. Meeting one of the following conditions at the time of recruitment: a) starting an eligible therapy during the recruitment period, or b) being in an active dose titration phase, with an upward dose escalation documented by the treating physician, even if treatment started four or more weeks earlier, provided the participant has not yet reached a stable maintenance dose\n6. Willingness and ability to attend follow up evaluations at 24 weeks (plus or minus 3 weeks) and 52 weeks (plus or minus 6 weeks)\n\nExclusion Criteria:\n\n1. Diagnosis of type 1 diabetes or other specific forms of diabetes\n2. Pregnancy or breastfeeding at the time of recruitment\n3. Conditions that limit adequate measurement of body composition by DXA, including body weight above the equipment's technical limit of 159 kg, the presence of metallic devices or materials that interfere with the measurement, or having undergone a radiologic contrast study within the 7 days before the evaluation\n4. Acute illness at the time of recruitment that could interfere with the study evaluations or with longitudinal follow up, including hospitalization within the 4 weeks before the baseline visit, active pneumonia, acute COVID-19 infection, diabetic ketoacidosis, or major surgery within the 6 weeks before recruitment\n5. Chronic diseases or conditions associated with severe alterations in body composition, such as active cancer, active systemic inflammatory disease, advanced heart failure, or kidney disease on replacement therapy\n6. Current or recent use, within 3 months, of systemic corticosteroids at chronic pharmacologic doses or medications with a direct modulating effect on muscle mass\n7. Current or recent use, within 3 months before the index date, of weight loss medications other than GLP-1RA, such as phentermine, topiramate, or naltrexone/bupropion\n8. Simultaneous participation in a double blind randomized clinical trial","locations":[{"facility":"Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"RECRUITING","lat":null,"lon":null},{"facility":"Instituto de Diabetes, Obesidad y Nutrición, S.C","city":"Mexico City","state":"Mexico City","country":"Mexico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in Appendicular Lean Mass","Change in Appendicular Skeletal Muscle Index (ASMI)"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["mexico-city-mexico"],"enrichment":{"headline":"Body Composition Changes After Initiation of GLP-1 Receptor Agonists in Adults With Obesity or Type 2 Diabetes","inPlainEnglish":"Researchers want to understand what happens to muscle and fat in the body after adults with obesity and/or type 2 diabetes start taking a GLP-1 receptor agonist medication (GLP-1RA), a type of drug already approved and commonly prescribed for weight loss and blood sugar control. No experimental medication will be given.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Diagnosis of obesity and/or type 2 diabetes mellitus, documented in the clinical record","Willingness and ability to attend follow up evaluations at 24 weeks (plus or minus 3 weeks) and 52 weeks (plus or minus 6 weeks)"],"whoShouldSkip":["Diagnosis of type 1 diabetes or other specific forms of diabetes","Pregnancy or breastfeeding at the time of recruitment","Chronic diseases or conditions associated with severe alterations in body composition, such as active cancer, active systemic inflammatory disease, advanced heart failure, or kidney disease on replacement therapy","Current or recent use, within 3 months, of systemic corticosteroids at chronic pharmacologic doses or medications with a direct modulating effect on muscle mass","Current or recent use, within 3 months before the index date, of weight loss medications other than GLP-1RA, such as phentermine, topiramate, or naltrexone/bupropion","Simultaneous participation in a double blind randomly assigned clinical trial"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.036Z"},{"nctId":"NCT07836530","title":"Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Advanced Hepatocellular Carcinoma","officialTitle":"A Randomized, Open-Label, Phase 3 Study to Investigate the Efficacy and Safety of BGB-B2033 Compared With Investigator Choice of Sorafenib or Lenvatinib in Patients With Hepatocellular Carcinoma That Progressed Upon Prior Systemic Treatment","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"BeOne Medicines","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer.\n\nThe main questions it aims to answer are:\n\n* Does BGB-B2033 help control or slow the growth of liver cancer?\n* What medical problems or side effects do participants have while taking BGB-B2033?\n* Does BGB-B2033 help to prolong the survival for liver cancer participants over Lenvatinib/sorafenib?","conditions":["Hepatocellular Carcinoma","Liver Cancer"],"keywords":["Liver Cancer","Hepatocellular Carcinoma","Sorafenib","Lenvatinib","BGB-B2033"],"interventions":[{"type":"DRUG","name":"BGB-B2033"},{"type":"DRUG","name":"Lenvatinib"},{"type":"DRUG","name":"Sorafenib"}],"enrollment":492,"startDate":"2026-10-23","completionDate":"2029-09-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.\n2. Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing Programmed Cell Death Protein 1 / Programmed Death-Ligand 1 (PD-1/PD-L1). Prior cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting therapy or v ascular endothelial growth factor (VEGF) is permitted but not required.\n3. Glypican-3 (GPC3) expression level must be known for stratification.\n4. Participants must have at least 1 measurable lesion as assessed by RECIST v1.1\n5. Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n\nKey Exclusion Criteria:\n\n1. Prior therapy targeting GPC3 or 4-1BB\n2. Participants not feasible to be treated with lenvatinib or sorafenib\n\n   1. prior exposure to both medications\n   2. significant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thrombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,\n   3. any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,\n   4. or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug.\n3. Active leptomeningeal disease or uncontrolled and untreated brain metastasis\n4. History of previous or present encephalopathy\n5. Presence of clinically significant ascites ((≥ Grade 2).\n6. History of liver transplantation\n\nNOTE: Other eligibility criteria may apply.","locations":[{"facility":"Icon Cancer Centre South Brisbane","city":"South Brisbane","state":"Queensland","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Auckland City Hospital","city":"Grafton","state":"Auckland","country":"New Zealand","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"1-877-828-5568","email":"clinicaltrials@beonemed.com"}],"primaryOutcomes":["Overall Survival (OS)"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["south-brisbane-australia","grafton-new-zealand"],"enrichment":{"headline":"Phase 3: testing BGB-B2033 for Hepatocellular Carcinoma","inPlainEnglish":"The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer.","whoItsFor":["Ages 18 Years to any","Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies","Glypican-3 (GPC3) expression level must be known for stratification","Participants must have at least 1 measurable lesion as assessed by RECIST v1.1","Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1"],"whoShouldSkip":["Prior therapy targeting GPC3 or 4-1BB","Participants not feasible to be treated with lenvatinib or sorafenib","prior exposure to both medications","significant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thrombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,","any history of gastrointestinal perforation or larger than grade 3 fistula within 6 months prior to the first dose,","or any history of heart failure meeting NYHA classification III or IV ≤ 6 months before the first dose of study drug","Active leptomeningeal disease or uncontrolled and untreated brain metastasis"],"whatHappens":"If you join, the listed intervention(s) are BGB-B2033, Lenvatinib, or Sorafenib. The registry lists allocation as randomized. The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 492 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.619Z"},{"nctId":"NCT07836647","title":"An Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of TSND-201 for the Treatment of PTSD","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Transcend Therapeutics","sponsorClass":"INDUSTRY","summary":"This study is evaluating the safety and efficacy of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomized 1:1:1 to receive one of two doses of TSND-201 or placebo, once per week. Following the Treatment Period, participants will enter an 8-week Follow-up Period.","conditions":["Post Traumatic Stress Disorder"],"keywords":["PTSD","EMPOWER-2","Transcend Therapeutics","TSND-201","Neuroplastogen"],"interventions":[{"type":"DRUG","name":"TSND-201"},{"type":"DRUG","name":"Placebo"}],"enrollment":300,"startDate":"2026-09-25","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months.\n* Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy.\n* Proficient in communication (verbal and reading) to complete interviews and written questionnaires.\n* Free from any other clinically significant illness or disease.\n\nExclusion Criteria:\n\n* Primary diagnosis of any other DSM-5 disorder.\n* Body mass index (BMI) \\<18kg/m2 or ≥40 kg/m2.\n* Unable to refrain from nicotine use for at least 8 hours.\n* Use of prohibited concomitant medications or therapies.\n* Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions.","locations":[{"facility":"Mountain View Clinical Research","city":"Denver","state":"Colorado","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bradenton Research Center","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CNS Healthcare","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Tampa","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"K2 Medical Research Tampa","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Atlanta","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CenExel Marlton","city":"Marlton","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bio Behavioral Health","city":"Toms River","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Clinical Research","city":"Draper","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"650-769-6472","email":"amanda@transcendtherapeutics.com"}],"primaryOutcomes":["Change from Baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Total Severity Score"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["denver-colorado","bradenton-florida","orlando-florida","tampa-florida","atlanta-georgia","marlton-new-jersey","toms-river-new-jersey","draper-utah"],"enrichment":{"headline":"Phase 3: testing TSND-201 for Post Traumatic Stress Disorder","inPlainEnglish":"This study is evaluating the safety and how well it works of TSND-201 in adults with PTSD. Eligible participants will enter a 4-week Treatment Period where they will be randomly assigned 1:1:1 to receive one of two doses of TSND-201 or dummy treatment (placebo), once per week.","whoItsFor":["Ages 18 Years to any","Meets DSM-5 criteria for current PTSD diagnosis, with a symptom duration of at least 6 months","Tried at least one pharmacological treatment for PTSD or trauma-focused psychotherapy","Proficient in communication (verbal and reading) to complete interviews and written questionnaires","Free from any other clinically significant illness or disease"],"whoShouldSkip":["Primary diagnosis of any other DSM-5 disorder","Body mass index (body-mass index (BMI)) \\<18kg/m2 or ≥40 kg/m2","Unable to refrain from nicotine use for at least 8 hours","Use of prohibited concomitant medications or therapies","Current or previous history of clinically significant cardiovascular (including current uncontrolled hypertension) / cerebrovascular conditions"],"whatHappens":"If you join, the listed intervention(s) are TSND-201, or Placebo. The registry lists allocation as randomized. This study is evaluating the safety and how well it works of TSND-201 in adults with PTSD.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.408Z"},{"nctId":"NCT07836751","title":"Using Gaze to Enable Head-neck Movements in Patients With Head Drop","officialTitle":"Using Gaze to Enable Personalized Head-neck Movements Through a Powered Neck Exoskeleton","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Utah","sponsorClass":"OTHER","summary":"The investigators will develop and evaluate controllers for a powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand how to allow adequate personalization and function and achieves satisfaction from users. In this small device feasibility study, participants will be enrolled from the ALS clinic at the University of Utah Hospital. After obtaining written consent, participants will perform tasks while using the neck exoskeleton with the controllers. Tasks include computerized tracking tasks and simulated activities of daily living. Breaks will be added between tasks to avoid fatigue. Head-neck kinematics, gaze data, controller preferences, and survey responses will be recorded.","conditions":["Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders"],"keywords":["dropped head syndrome"],"interventions":[{"type":"DEVICE","name":"neck exoskeleton controller"}],"enrollment":12,"startDate":"2025-06-30","completionDate":"2026-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* neck weakness and age over 18\n\nExclusion Criteria:\n\n* Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting.","locations":[{"facility":"Utah Wearable Robotics Laboratory, Dept. of Mechanical Engineering","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Research Coordinator","phone":"801-585-2536","email":"uwrl@UofUtah.onmicrosoft.com"}],"primaryOutcomes":["number of tuning"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["salt-lake-city-utah"],"enrichment":{"headline":"Not a traditional drug phase: neck exoskeleton controller for Amyotrophic Lateral Sclerosis & Other Neuromuscular Disorders","inPlainEnglish":"The investigators will develop and evaluate controllers for a powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand how to allow adequate personalization and function and achieves satisfaction from users. In this small device feasibility study, you would be enrolled from the ALS clinic at the University of Utah Hospital.","whoItsFor":["Ages 18 Years to any","neck weakness and age over 18"],"whoShouldSkip":["Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting"],"whatHappens":"If you join, the listed intervention(s) are neck exoskeleton controller. The registry lists allocation as randomized. The investigators will develop and evaluate controllers for a powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand how to allow adequate personalization and function and achieves satisfaction from users.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 12 people at Salt Lake City. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.621Z"},{"nctId":"NCT07837739","title":"Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC","officialTitle":"A Multicenter Registry Study of Adjuvant EGFR-TKI Therapy Following Curative Resection for EGFR-Mutant High-Risk Stage IA2-IIB Non-Small Cell Lung Cancer","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Tongji Hospital","sponsorClass":"OTHER","summary":"This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection.\n\nPostoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.","conditions":["Non-Small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Adjuvant EGFR-TKI Therapy"}],"enrollment":100,"startDate":"2025-07-02","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-75 years, male or female, with written informed consent.\n* Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma / predominantly non-squamous histology.\n* For stage IA2 disease, at least one protocol-defined high-risk feature: invasive component \\>2 cm; lymphovascular invasion; high-grade pattern comprising ≥20% solid, micropapillary, cribriform, or complex glandular components; spread through air spaces (STAS); or sublobar resection (segmentectomy/wedge resection).\n* EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation.\n* Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol.\n* No previous antitumor treatment, including no neoadjuvant radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n* ECOG Performance Status 0-1.\n* Hematologic criteria: RBC ≥3.0×10\\^12/L; WBC ≥3.5×10\\^9/L; ANC ≥1.5×10\\^9/L; platelet count ≥100×10\\^9/L; hemoglobin ≥90 g/L.\n* Renal function: serum creatinine ≤1.2×ULN.\n* Hepatic function: total bilirubin ≤1.5×ULN; ALT and AST ≤1.5×ULN.\n* Able and willing to comply with protocol-specified treatment/observation and follow-up.\n* Adequate tumor tissue available and willingness to provide tissue and blood samples for study analyses.\n* Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study.\n\nExclusion Criteria:\n\n* Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment/evaluation.\n* Any systemic disease incompatible with participation in the clinical study or inability to provide written informed consent.\n* Pregnancy or breastfeeding.\n* Known active alcohol or drug abuse or dependence.\n* Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","locations":[{"facility":"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wei Ping, Dr.","phone":"13437101581","email":"pingwei@tjh.tjmu.edu.cn"}],"primaryOutcomes":["Disease-Free Survival (DFS)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["wuhan-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Adjuvant EGFR-TKI Therapy for Non-Small Cell Lung Cancer","inPlainEnglish":"This prospective, multicenter patient registry is designed to measure the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers.","whoItsFor":["Ages 18 Years to 75 Years","Histologically confirmed primary non-small cell lung cancer, pathologic stage IA2 to IIB; protocol summary further specifies lung adenocarcinoma / predominantly non-squamous histology","EGFR mutation-positive disease confirmed by the central laboratory, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutation","Complete surgical resection with negative margins (R0); lobectomy or sublobar resection may be included according to the protocol","No previous antitumor treatment, including no neoadjuvant radiotherapy, chemotherapy, targeted therapy, or immunotherapy","how well you can do daily activities (ECOG score) 0-1","Hematologic criteria: RBC ≥3.0×10\\^12/L; WBC ≥3.5×10\\^9/L; ANC ≥1.5×10\\^9/L; platelet count ≥100×10\\^9/L; hemoglobin ≥90 g/L","Renal function: serum creatinine ≤1.2×ULN"],"whoShouldSkip":["Contraindication to anesthesia or surgery, or death attributable to the surgical procedure before study enrollment/evaluation","Pregnancy or breastfeeding","Known active alcohol or drug abuse or dependence","Any serious or unstable medical condition or psychiatric disorder that, in the investigator's judgment, would make participation inappropriate","Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Wuhan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.686Z"},{"nctId":"NCT07839247","title":"Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed PCNSL","officialTitle":"Zanubrutinib Plus Lenalidomide for Frail Elderly Patients With Newly Diagnosed Primary CNS Lymphoma: a Prospective, Single-arm, Phase II Clinical Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Xiaohui Ren","sponsorClass":"OTHER","summary":"This is a prospective, single-arm, phase II clinical study evaluating the efficacy and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study plans to enroll 33 patients who are aged ≥ 70 years and classified as frail, a population for whom standard first-line treatment regimens, high-dose methotrexate-based chemotherapy, may be \"unfit\". This study includes screening phase, induction phase, consolidation phase and maintenance phase. The screening period is defined as within 1 week prior to the first dose. During induction, participants will receive Zanubrutinib 160 mg orally twice daily continuously and Lenalidomide 25 mg orally once daily on days 1-21 of each 28-day cycle for three cycles. Participants who achieve a partial response (PR) or complete response (CR) after induction will receive three additional 28-day consolidation cycles of the same regimen. Participants who achieve a CR after consolidation will continue maintenance treatment with Zanubrutinib and Lenalidomide until disease progression. Treatment response will be assessed throughout the study using the International Primary CNS Lymphoma Collaborative Group (IPCG) criteria and assessed every 3 months. The primary endpoint is the complete response rate (CRR) at the end of induction therapy. Secondary endpoints include overall response rate (ORR) at the end of induction therapy, CRR and ORR at the end of consolidation therapy, One-year and two-year progression-free survival (PFS) rates, Duration of response (DOR), overall survival (OS), adverse event (AE) and serious adverse event (SAE). Exploratory liquid-biopsy analyses will be performed to evaluate treatment response and prognosis.","conditions":["Primary Central Nervous System Lymphoma (PCNSL)","Zanubrutinib","Lenalidomide","Frail Elderly"],"keywords":["primary central nervous system lymphoma","elderly","frail","zanubrutinib","lenalidomide"],"interventions":[{"type":"DRUG","name":"Zanubrutinib"},{"type":"DRUG","name":"Lenalidomide"}],"enrollment":33,"startDate":"2026-09-25","completionDate":"2027-10-01","sex":"ALL","minAge":"70 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\n1. Age ≥ 70 years.\n2. patients classified as \"Frail\"according to the simplified Geriatric Assessment (sGA):\n\n   --ADL ≤ 4 residual functions, or\n   * IADL ≤ 5 residual functions, or\n   * CIRS: ≥ 1 comorbidity of grade 3-4 or \\> 8 comorbidities of grade 2, or\n   * Age ≥ 80 years with \"UNFIT\" profile \"UNFIT\" profile: ADL = 5 residual functions or IADL = 6-7 residual functions, or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2.\n3. Voluntary provision of written informed consent.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n5. Considered able to safely undergo lumbar puncture.\n6. Life expectancy of ≥ 3 months, as judged by the investigator.\n7. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) confined to the central nervous system (CNS).\n8. Hematologic function: absolute neutrophil count ≥ 1.5 x 10\\^9/L, hemoglobin ≥ 90 g/L, and platelet count ≥ 80 x 10\\^9/L.\n9. Hepatic function: serum total bilirubin ≤ 1.5 x the upper limit of normal (ULN), and serum alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN.\n10. Renal function: creatinine clearance ≥ 30 mL/min, as estimated using the Cockcroft-Gault formula, or serum creatinine ≤ 1.5 x ULN.\n11. Coagulation function: international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN.\n12. Female participants of childbearing potential must have a negative pregnancy test within 7 days before the first dose and agree not to donate oocytes for reproductive purposes throughout the treatment and follow-up periods. Their male sexual partners must use condoms during sexual intercourse.\n13. Male participants with female partners of childbearing potential must use condoms during sexual intercourse throughout the study and refrain from donating or cryopreserving sperm during this period.\n14. Participants with stable and adequately controlled comorbidities may be enrolled, including those with hypertension (blood pressure ≤ 160/100 mmHg), type 2 diabetes mellitus (HbA1c ≤ 8%), or mild coronary artery disease without myocardial infarction within the preceding 6 months.\n\nExclusion Criteria\n\n1. Any disease or condition that may impair drug absorption (e.g., active inflammatory gastrointestinal disease, active gastric ulcer, chronic diarrhea, dysphagia, prior gastrectomy, gastroparesis, or short bowel syndrome).\n2. Known hypersensitivity to zanubrutinib, lenalidomide, or any excipient contained in either drug.\n3. Active bleeding within 1 month before treatment; a need for therapeutic anticoagulation during the study (e.g., warfarin or other vitamin K antagonists); or any condition associated with an increased risk of bleeding or coagulopathy (e.g., high-risk esophageal varices or active ulcer disease).\n4. High risk of thrombosis.\n5. Concurrent participation in another interventional clinical study (participation in noninterventional observational studies is permitted).\n6. Major surgery within 4 weeks before treatment or an incompletely healed surgical incision.\n7. Treatment with systemic corticosteroids within 4 weeks before treatment.\n8. Another active malignancy or a history of another malignancy within 5 years before the initiation of study treatment, except for malignancies adequately treated with curative intent, such as basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast.\n9. Receipt of any vaccine, including but not limited to a vaccine against COVID-19, influenza, pneumonia, herpes zoster, or hepatitis B, within 4 weeks before the first dose.\n10. Requirement for treatment with a moderate or strong CYP3A4/5 inhibitor or inducer within 2 weeks before the first dose or during the study;\n11. Stroke or intracranial hemorrhage within 6 months before the first dose.\n12. Known liver disease, including but not limited to alcoholic liver disease, cirrhosis, active hepatitis B virus (HBV) infection (detectable HBV DNA), active hepatitis C virus (HCV) infection (detectable HCV RNA), or other active hepatitis. Participants with HBV DNA below the limit of detection or cured HCV infection are not excluded. Participants with HBV or HCV infection may be enrolled after antiviral therapy, provided that HBV DNA is below the limit of detection or HCV RNA is undetectable, as applicable.\n13. Active syphilis.\n14. Human immunodeficiency virus (HIV) infection\n15. Epstein-Barr virus (EBV) infection\n16. An active infection requiring systemic treatment or unexplained fever with a body temperature ≥ 38.5℃ within 1 week before treatment;\n17. Any of the following cardiac or cardiovascular criteria:\n\n（1）A heart rate-corrected QT interval calculated using Fridericia's formula (QTcF) \\> 470 ms in females or \\> 450 ms in males, or other risk factors for QT-interval prolongation or arrhythmic events (e.g., hypokalemia or a personal or family history of long QT syndrome); （2）A clinically significant arrhythmia or other cardiovascular disease requiring clinical intervention, including but not limited to acute myocardial infarction, unstable angina, or coronary artery bypass grafting within 6 months before treatment; congestive heart failure of New York Heart Association (NYHA) class II or higher; left ventricular ejection fraction (LVEF) \\< 50%; hypertension not controlled with medication (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg); atrial fibrillation of European Heart Rhythm Association (EHRA) class ≥ 2b; or primary cardiomyopathy.\n\n18\\. Prior organ transplantation or allogeneic stem cell transplantation.\n\n19\\. Prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, or radiation pneumonitis considered by the investigator to render the patient unsuitable for the study.\n\n20\\. An autoimmune disease requiring systemic treatment within the previous 2 years.\n\n21\\. Incomplete clinical data (e.g., no pathology report or inability to undergo MRI or PET/CT assessment).\n\n22\\. Pregnant (positive pregnancy test before dosing) or breastfeeding.\n\n23\\. Any other disease, psychiatric disorder, metabolic abnormality, physical examination finding, or clinically significant laboratory abnormality that, in the investigator's judgment, may compromise the participant's adherence to the study requirements, expose the participant to an unacceptable risk, interfere with the interpretation of the study results, or otherwise render the participant unsuitable for treatment with the study drugs.\n\n24\\. Any other circumstance that, in the investigator's judgment, renders the patient unsuitable for participation in the study.","locations":[{"facility":"Deparment of neurosurgery, Beijing tiantan hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaohui Ren, MD","phone":"+86-010-59975567","email":"xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com"},{"name":"Haoyi Li, MD","phone":"+86-010-59975567","email":"lee_627269051@163.com"}],"primaryOutcomes":["CRR"],"hasResults":false,"conditionSlugs":["lymphoma"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing Zanubrutinib for Primary Central Nervous System Lymphoma (PCNSL)","inPlainEnglish":"This is a prospective, single-arm, phase II clinical study evaluating the how well it works and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL). The study plans to enroll 33 patients who are aged ≥ 70 years and classified as frail, a population for whom standard first-line treatment regimens, high-dose methotrexate-based chemotherapy, may be \"unfit\".","whoItsFor":["Ages 70 Years to any","patients classified as \"Frail\"according to the simplified Geriatric Assessment (sGA):","ADL ≤ 4 residual functions, or","IADL ≤ 5 residual functions, or","CIRS: ≥ 1 comorbidity of grade 3-4 or \\> 8 comorbidities of grade 2, or","Age ≥ 80 years with \"UNFIT\" profile \"UNFIT\" profile: ADL = 5 residual functions or IADL = 6-7 residual functions, or CIRS: 0 comorbidity of grade 3-4 and 5-8 comorbidities of grade 2","Eastern Cooperative Oncology Group (ECOG) performance status of 0-3","Considered able to safely undergo lumbar puncture"],"whoShouldSkip":["Any disease or condition that may impair drug absorption (e.g., active inflammatory gastrointestinal disease, active gastric ulcer, chronic diarrhea, dysphagia, prior gastrectomy, gastroparesis, or short bowel syndrome)","Known hypersensitivity to zanubrutinib, lenalidomide, or any excipient contained in either drug","High risk of thrombosis","Concurrent participation in another treatment clinical study (participation in noninterventional watch-and-measure (no experimental treatment required) studies is permitted)","Major surgery within 4 weeks before treatment or an incompletely healed surgical incision","Treatment with systemic corticosteroids within 4 weeks before treatment","Receipt of any vaccine, including but not limited to a vaccine against COVID-19, influenza, pneumonia, herpes zoster, or hepatitis B, within 4 weeks before the first dose"],"whatHappens":"If you join, the listed intervention(s) are Zanubrutinib, or Lenalidomide. The registry lists allocation as na. This is a prospective, single-arm, phase II clinical study evaluating the how well it works and safety of Zanubrutinib (a BTK inhibitor) plus Lenalidomide (an immunomodulatory drug) in frail elderly patients with newly diagnosed primary central nervous system lymphoma (PCNSL).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 33 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.144Z"},{"nctId":"NCT07839650","title":"Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training in Alzheimer's Disease","officialTitle":"Interventional Study to Evaluate the Effectiveness of Transcranial Alternating Current Stimulation (tACS) Combined With Cognitive Training on Cognitive Performance in Patients With Alzheimer's Disease","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"IRCCS Centro San Giovanni di Dio Fatebenefratelli","sponsorClass":"OTHER","summary":"The aim of the study is to evaluate the clinical and biological efficacy, as well as predictors of efficacy, of a home-based intervention combining transcranial alternating current stimulation (tACS) with individualized computerized cognitive training in patients with mild Alzheimer's disease (AD).\n\nIn neurodegenerative diseases, including AD, neurodegeneration is accompanied by alterations in brain oscillatory activity. Restoration of these oscillations through neuronal entrainment has shown beneficial effects in animal models, while previous studies in patients with AD have demonstrated that gamma-frequency tACS applied over the precuneus is safe and well tolerated and is associated with improvements in cognitive performance and cholinergic function, as well as modulation of brain oscillatory activity. Cognitive rehabilitation may also improve memory performance in patients with mild AD. Based on this evidence, the present study investigates a multimodal approach combining gamma-tACS with individualized computerized memory training.\n\nThe study is a multicenter, randomized, placebo-controlled, double-blind trial involving 30 participants with mild AD. Participants will be randomly assigned to one of two groups: Group 1 will receive real gamma-tACS for 8 weeks (5 sessions/week, 60 minutes/session) combined with cognitive training (2 sessions/week, 30 minutes/session); Group 2 will receive sham tACS according to the same schedule, combined with the same cognitive training. tACS will be applied over the precuneus. Treatment will initially be performed in the hospital and will subsequently be administered at home under remote supervision by the study team.\n\nAssessments will be performed at baseline (T00), after 8 weeks of treatment (T08), and at follow-up visits at 16 weeks (T16) and 24 weeks (T24) from baseline. At each time point, participants will undergo clinical and neuropsychological assessment, blood sampling, and transcranial magnetic stimulation (TMS). The occurrence of adverse events will be monitored throughout the duration of the study.\n\nThe main objectives of the study are: 1) to evaluate the short- and long-term effects of the combined intervention on cognitive performance; 2) to investigate intervention-induced changes in biological markers of neurodegeneration, inflammation, and synaptic function; 3) to evaluate the effects of the intervention on cholinergic transmission through the TMS short-latency afferent inhibition (SAI) measure; and 4) to investigate potential predictors of treatment efficacy.","conditions":["Transcranial Alternating Current Stimulation","Alzheimer Disease (AD)","Alzheimer Dementia (AD)","Cognitive Rehabilitation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Transcranial Alternating Current Stimulation"},{"type":"DEVICE","name":"Sham Transcranial Alternating Current Stimulation"},{"type":"BEHAVIORAL","name":"Individualized Computerized Memory Training"}],"enrollment":30,"startDate":"2026-09-16","completionDate":"2031-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPatients:\n\n* Male or female participants aged ≥18 years at the time of signing the informed consent form;\n* Clinical diagnosis of mild Alzheimer's disease (AD) according to current clinical criteria;\n* Availability of a caregiver who can assist the participant and who has successfully completed the required training for the use of the device at home.\n\nCaregivers:\n\n* Male or female caregivers aged ≥18 years;\n* Compliance with participation in the in-hospital training;\n* Mini-Mental State Examination (MMSE) score \\>27/30.\n\nExclusion Criteria:\n\n* Age below that specified in the inclusion criteria;\n* Inability to understand;\n* Contraindications to tACS and TMS (e.g., presence of a cardiac pacemaker or metallic implants incompatible with electrical or magnetic fields, history of epilepsy, or current pregnancy, as assessed using the safety questionnaire).","locations":[{"facility":"IRCCS Istituto Centro San Giovanni Di Dio - Fatebenefratelli","city":"Brescia","state":"Brescia","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS S. Maria Nascente - Fondazione Don Carlo Gnocchi","city":"Milan","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Mini-Mental State Examination (MMSE)","Semantic Fluency Test","Trail Making Test (TMT - A, B)","Rey Auditory Verbal Learning Test (RAVLT)","Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13)","Face-Name Associative Memory Test (FNAT)","Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)","Neuropsychiatric Inventory (NPI)","Clinical Dementia Rating scale - Sum of Boxes (CDR-SoB)","Clinical Dementia Rating scale - Global Score (CDR-GS)","Zarit Burden Interview (ZBI)"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["brescia-italy","milan-italy"],"enrichment":{"headline":"Not a traditional drug phase: Transcranial Alternating Current Stimulation for Transcranial Alternating Current Stimulation","inPlainEnglish":"The aim of the study is to measure the clinical and biological how well it works, as well as predictors of how well it works, of a home-based intervention combining transcranial alternating current stimulation (tACS) with individualized computerized cognitive training in patients with mild Alzheimer's disease (AD). In neurodegenerative diseases, including AD, neurodegeneration is accompanied by alterations in brain oscillatory activity.","whoItsFor":["Ages 18 Years to any","Clinical diagnosis of mild Alzheimer's disease (AD) according to current clinical criteria;","Availability of a caregiver who can assist the participant and who has successfully completed the required training for the use of the device at home","Male or female caregivers aged ≥18 years;","Compliance with participation in the in-hospital training;","Mini-Mental State Examination (MMSE) score \\>27/30"],"whoShouldSkip":["Age below that specified in the who can join;","Inability to understand;","Contraindications to tACS and TMS (e.g., presence of a cardiac pacemaker or metallic implants incompatible with electrical or magnetic fields, history of epilepsy, or current pregnancy, as assessed using the safety questionnaire)"],"whatHappens":"If you join, the listed intervention(s) are Transcranial Alternating Current Stimulation, Sham Transcranial Alternating Current Stimulation, or Individualized Computerized Memory Training. The registry lists allocation as randomized. The aim of the study is to measure the clinical and biological how well it works, as well as predictors of how well it works, of a home-based intervention combining transcranial alternating current stimulation (tACS) with individualized computerized cognitive training in patients with mild Alzheimer's disease (AD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at 2 sites. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.329Z"},{"nctId":"NCT07839936","title":"A Study of VERVE-102 (LY4636581) in Adults With or at High Risk for Cardiovascular Disease","officialTitle":"A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of VERVE-102, a One-Time Dose Gene Editing Medicine, in Adults With or at High Risk for Atherosclerotic Cardiovascular Disease (ASCVD) Who Require Additional Low-Density Lipoprotein-Cholesterol (LDL-C) Lowering","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Verve Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to placebo in adults who have plaque buildup in their arteries or are at high risk of developing it.","conditions":["Atherosclerosis","Cardiovascular Disease","Hypercholesterolemia"],"keywords":["Heterozygous Familial Hypercholesterolemia","LDL cholesterol","High cholesterol","Cardiovascular risk factors","Coronary Artery Disease","Heart attack","Stroke","Base editing"],"interventions":[{"type":"DRUG","name":"VERVE-102"},{"type":"DRUG","name":"Placebo"}],"enrollment":175,"startDate":"2026-09-24","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD\n\nExclusion Criteria:\n\n* History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)\n* Chronic liver disease\n* Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe","locations":[{"facility":"Epic Medical Research","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percent Change from Baseline in LDL-C"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["desoto-texas"],"enrichment":{"headline":"Phase 2: testing VERVE-102 for Atherosclerosis","inPlainEnglish":"This study wants to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to dummy treatment (placebo) in adults who have plaque buildup in their arteries or are at high risk of developing it.","whoItsFor":["Ages 18 Years to 70 Years","Established atherosclerotic cardiovascular disease (ASCVD) and/or at a high risk of ASCVD"],"whoShouldSkip":["History of confirmed or suspected homozygous familial hypercholesterolemia (HoFH)","Chronic liver disease","Current treatment with PCSK9 inhibitor or prior treatment within specified timeframe"],"whatHappens":"If you join, the listed intervention(s) are VERVE-102, or Placebo. The registry lists allocation as randomized. This study wants to measure the change in bad cholesterol (LDL-C) with VERVE-102 compared to dummy treatment (placebo) in adults who have plaque buildup in their arteries or are at high risk of developing it.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 175 people at DeSoto. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.215Z"},{"nctId":"NCT07840287","title":"A Long-Term Extension (LTE) Study Of Enpatoran In Cutaneous Manifestations Of Lupus With Or Without Systemic Disease [Elowen-LTE]","officialTitle":"A Phase 3, Single-Arm, Open-Label, Long-Term Extension Study To Evaluate The Safety And Efficacy Of Enpatoran In Participants With Active Cutaneous Manifestations Of Lupus Erythematosus With Or Without Systemic Disease Receiving Standard Of Care [Elowen-LTE]","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"EMD Serono Research & Development Institute, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the long-term safety and efficacy of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\\_0001) (NCT07332481) and Elowen-2 (MS504908\\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include:\n\nStudy Duration: 120 weeks. Treatment Duration: 108 weeks. Visit Frequency: Every 4 weeks (from Week 4 to Week 24) and every 12 weeks (from Week 36 to Week 120).\n\nStudy Intervention: Enpatoran. Intervention Form: Film-coated tablet.","conditions":["Systemic Lupus Erythematosus (SLE)","Cutaneous Lupus Erythematosus (CLE)"],"keywords":["Toll-like receptor 7","Toll-like receptor 8","WILLOW","Elowen-1","Elowen-2","Adults","Systemic lupus erythematosus","Cutaneous lupus erythematosus","Discoid lupus erythematosus","Subacute cutaneous lupus erythematosus","Acute cutaneous lupus erythematosus","Interferon-gene signature"],"interventions":[{"type":"DRUG","name":"Enpatoran"}],"enrollment":404,"startDate":"2026-10-22","completionDate":"2031-09-01","sex":"ALL","minAge":"18 Years","maxAge":"76 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory.\n2. Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit.\n\nExclusion Criteria:\n\n1. Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study.\n2. Other severe acute or chronic medical or psychiatric condition. Clinically significant ECG findings or laboratory abnormality that may increase the risk associated with LTE study participation or study intervention administration and, in the judgment of the Investigator, would make the participant inappropriate to participate in this LTE study.\n3. Active clinically significant viral (including Severe Acute Respiratory Syndrome Coronavirus \\[SARS CoV\\] 2), bacterial (including active tuberculosis or untreated latent tuberculosis), parasitic, or fungal infection or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives. Vaginal candidiasis, onychomycosis, and genital or oral herpes simplex virus considered sufficiently controlled will not be exclusionary.\n\n   Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor.\n\n   • All participants who entered Elowen-1 and Elowen-2 studies with positive anti-hepatitis B core (HBc) antibody and/or anti hepatitis B surface (HBs) antibody with non-detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) at Screening must provide a negative HBV DNA polymerase chain reaction (PCR) result.\n4. Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor).\n5. Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit.\n6. Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal.\n7. Planned major elective medical or surgical procedure.","locations":[{"facility":"Revival Research Institute, LLC","city":"Troy","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US Medical Information","phone":"888-275-7376","email":"eMediUSA@emdserono.com"},{"name":"Communication Center","phone":"+49 6151 72 5200","email":"service@emdgroup.com"}],"primaryOutcomes":["Number of Participants With Treatment Emergent adverse events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["troy-michigan"],"enrichment":{"headline":"Phase 3: testing Enpatoran for Systemic Lupus Erythematosus (SLE)","inPlainEnglish":"This study wants to measure the long-term safety and how well it works of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\\_0001) (NCT07332481) and Elowen-2 (MS504908\\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study. Study details include: Study Duration: 120 weeks.","whoItsFor":["Ages 18 Years to 76 Years","Are up to date according to local guidelines/ recommendations. Recombinant zoster vaccination is encouraged but not mandatory","Are participants with active cutaneous manifestations of lupus erythematosus that have successfully completed the 24-week treatment of the Elowen-1 or Elowen-2 study, including the Week 24 end of treatment (EOT) visit"],"whoShouldSkip":["Participants who experienced serious event(s) related to the study intervention during the Elowen-1 and Elowen-2 studies, an unstable medical condition, or any other reason, in the opinion of the Investigator that would preclude participation in this LTE study","Note: if sign/symptoms suggest any underlying infection (at Investigator discretion), a negative or normal test result must be provided and discussed with the Medical Monitor","Received LTE-prohibited medication during participation in Elowen 1 or Elowen-2 study or after Elowen-1 or Elowen-2 study Week 24/EOT visit (may require prior discussion with Medical Monitor)","Participation in any other investigational drug study after Elowen-1 or Elowen-2 study Week 24/EOT visit","Withdrawn during participation in Elowen-1 or Elowen-2 study due to any of the predefined criteria for study intervention or study withdrawal","Planned major elective medical or surgical procedure"],"whatHappens":"If you join, the listed intervention(s) are Enpatoran. The registry lists allocation as na. This study wants to measure the long-term safety and how well it works of orally administered enpatoran in participants with cutaneous manifestations of lupus erythematosus who have completed the Elowen-1 (MS504908\\_0001) (NCT07332481) and Elowen-2 (MS504908\\_0008) (NCT07355218) study treatment and to provide participants an opportunity to receive active treatment with enpatoran for up to 108 weeks in this open-label study.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 404 people at Troy. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.268Z"},{"nctId":"NCT07840326","title":"A Phase 2a Study of SUN-627 in Participants With Non-Active Secondary Progressive and Primary Progressive Multiple Sclerosis (SPMS/PPMS)","officialTitle":"A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of SUN-627 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Impact on Measures of Neuroinflammation in the Central Nervous System in Participants With Non-Active Progressive Multiple Sclerosis (SPMS/PPMS)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Sundance Biosciences, Inc.","sponsorClass":"INDUSTRY","summary":"The goal of this Phase 2 clinical trial is to investigate the safety and tolerability of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.","conditions":["Primary Progressive Multiple Sclerosis","Primary Progressive MS","Primary Progressive Multiple Sclerosis (PPMS)","Secondary Progressive MS (SPMS)","Secondary Progressive Multiple Sclerosis (SPMS)","Secondary Progressive MS","Non-Active SPMS","Non-Active Secondary Progressive Multiple Sclerosis","Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity"],"keywords":["Primary Progressive Multiple Sclerosis","Primary Progressive MS","Primary Progressive Multiple Sclerosis (PPMS)","Secondary Progressive Multiple Sclerosis (SPMS)","Secondary Progressive MS (SPMS)","Secondary Progressive Multiple Sclerosis","Secondary Progressive MS","Primary Progressive MS (PPMS)","Non-Active SPMS","Non-Active Secondary Progressive Multiple Sclerosis","Secondary Progressive Multiple Sclerosis with inflammatory disease activity","TYK2","CNS penetrant TYK2","Demyelinating disease","CNS demyelinating disease","Multiple Sclerosis","Confirmed disability progression","NfL","GFAP","Neuroinflammation","chronic active lesions","Slowly expanding lesions","Paramagnetic rim lesions","Progressive Multiple sclerosis"],"interventions":[{"type":"DRUG","name":"SUN-627"},{"type":"OTHER","name":"Placebo"}],"enrollment":20,"startDate":"2026-10","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 18-70, inclusive\n2. Diagnosis of PPMS or non-active SPMS\n3. No MS relapses in the past 2 years\n4. Evidence that MS has continued to get worse over time\n5. A level of disability that fits the study requirements\n\nExclusion Criteria:\n\n1. Use of certain medications or treatments before the study, or need for these treatments during the study\n2. Current participation in another research study\n3. Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk\n4. Certain serious or unstable medical conditions that could make the study unsafe\n5. Active infection, recent infection, or a history of repeated infections\n\nAdditional inclusion and exclusion criteria are outlined in the full study protocol.","locations":[{"facility":"Local Institution - Site 103","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 102","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 106","city":"Stony Brook","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 101","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 104","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 105","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Local Institution - Site 107","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chetan Gandhy, MD","phone":"650-442-3187","email":"clinicaltrials@sundancebio.com"}],"primaryOutcomes":["Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) compared to placebo"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["tampa-florida","atlanta-georgia","stony-brook-new-york","raleigh-north-carolina","columbus-ohio","oklahoma-city-oklahoma","dallas-texas"],"enrichment":{"headline":"Phase 2: testing SUN-627 for Primary Progressive Multiple Sclerosis","inPlainEnglish":"The goal of this Phase 2 clinical trial is to investigate the whether it is safe and how hard side effects are to live with of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.","whoItsFor":["Ages 18 Years to 70 Years","Aged 18-70, inclusive","Diagnosis of PPMS or non-active SPMS","No MS relapses in the past 2 years","Evidence that MS has continued to get worse over time","A level of disability that fits the study requirements"],"whoShouldSkip":["Use of certain medications or treatments before the study, or need for these treatments during the study","Current participation in another research study","Certain abnormal heart rhythm findings on ECG or other heart conditions that may increase risk","Certain serious or unstable medical conditions that could make the study unsafe","Active infection, recent infection, or a history of repeated infections","Additional inclusion and"],"whatHappens":"If you join, the listed intervention(s) are SUN-627, or Placebo. The registry lists allocation as randomized. The goal of this Phase 2 clinical trial is to investigate the whether it is safe and how hard side effects are to live with of SUN-627 in men and women aged 18-70 years old with a diagnosis of non-active SPMS/PPMS.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.980Z"},{"nctId":"NCT07840729","title":"Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants","officialTitle":"Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is \"Individual Patients.\" A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Shanghai JMT-Bio Inc.","sponsorClass":"INDUSTRY","summary":"Use these resources to provide understandable information about this study to patients, families, and health care providers:","conditions":["Valid MeSH Conditiongs"],"keywords":[],"interventions":[{"type":"DRUG","name":"JMT206 injection"},{"type":"COMBINATION_PRODUCT","name":"Semaglutide injection"},{"type":"DRUG","name":"Placebo injection"}],"enrollment":90,"startDate":"2026-10-20","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18\\~65 (including threshold values), male or female participants;\n2. BMI ≥ 30 kg/m²;\n3. Weight change \\<5% within the 3 months prior to screening\n4. Voluntarily sign the informed consent form before the trial..\n\nExclusion Criteria:\n\n1\\) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.\n\n\\-","locations":[{"facility":"Peking University People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Information Group officer","phone":"86-0311-69085587","email":"ctr-contact@mail.ecspc.com"}],"primaryOutcomes":["Incidence of Adverse Events (AE) assessed by CTCAE v6.0"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["semaglutide"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 1: testing JMT206 injection for Valid MeSH Conditiongs","inPlainEnglish":"Use these resources to provide understandable information about this study to patients, families, and health care providers:","whoItsFor":["Ages 18 Years to 65 Years","Age 18\\~65 (including threshold values), male or female participants;","Weight change \\<5% within the 3 months prior to screening"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are JMT206 injection, Semaglutide injection, or Placebo injection. The registry lists allocation as randomized. Use these resources to provide understandable information about this study to patients, families, and health care providers:","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.724Z"},{"nctId":"NCT07841990","title":"Substudy-01: A Study of Long-Acting HIV-1 Treatments Taken by Mouth in People With HIV-1 With Undetectable Virus Levels","officialTitle":"A Platform, Active-Controlled Study Evaluating the Safety and Efficacy of Long-Acting Oral Regimens in People With HIV-1; Substudy-01: Phase 2, Open-Label, Weekly, Long-Acting, Oral Regimens in Virologically Suppressed People With HIV-1","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Gilead Sciences","sponsorClass":"INDUSTRY","summary":"Master Protocol: The main goal of this master clinical study is to evaluate the safety, tolerability, efficacy, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).\n\nThe main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.\n\nThe primary objective is to evaluate the efficacy of switching to each LAO regimen versus continuing B/F/TAF in virologically suppressed PWH at Week 24.","conditions":["HIV-1 Infection"],"keywords":[],"interventions":[{"type":"DRUG","name":"B/F/TAF"},{"type":"DRUG","name":"GS-3242"},{"type":"DRUG","name":"Lenacapavir"}],"enrollment":125,"startDate":"2026-10-01","completionDate":"2027-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Individuals assigned male or female at birth, 18 years of age or older, able to understand and give written informed consent and comply with treatment and follow-up.\n* Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception.\n* Negative serum pregnancy test at screening and negative urine test at enrollment.\n* Receiving B/F/TAF for ≥ 6 months prior to screening.\n* Documented plasma HIV-1 RNA \\< 50 copies/mL for ≥ 6 months before and at screening.\n* No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports.\n* CD4 ≥ 200 cells/mm\\^3 at screening\n\nKey Exclusion Criteria:\n\n* Plans to breastfeed during the study period and 60 days following the last dose of study intervention.\n* History of virologic failure while on an integrase strand-transfer inhibitor-based regimen.\n* Creatinine clearance according to the Cockcroft-Gault formula \\< 60 mL/min.","locations":[{"facility":"Midway Immunology and Research Center","city":"Ft. Pierce","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Crofoot Research Center, INC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gilead Clinical Study Information Center","phone":"1-833-445-3230 (GILEAD-0)","email":"GileadClinicalTrials@gilead.com"}],"primaryOutcomes":["Proportion of Participants With HIV-1 Ribonucleic Acid (RNA) ≥ 50 copies/mL at Week 24 as Determined by the United States (US) Food and Drug Administration (FDA)-Defined Snapshot Algorithm"],"hasResults":false,"conditionSlugs":["hiv"],"drugSlugs":["lenacapavir"],"locationSlugs":["ft-pierce-florida","houston-texas"],"enrichment":{"headline":"Phase 2: testing B/F/TAF for HIV-1 Infection","inPlainEnglish":"Master Protocol: The main goal of this master clinical study is to measure the safety, tolerability, how well it works, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH). The main goal of this Substudy-01 is to assess the safety, tolerability, effectiveness, and PK of switching to weekly LAO regimens, including GS-3242 + LEN, versus continuing on once daily oral bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF; coformulated; Biktarvy®) in PWH with controlled HIV infection, B/F/TAF for at least 6 months prior to study start.","whoItsFor":["Ages 18 Years to any","Individuals assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use approved method(s) of contraception","Negative serum pregnancy test at screening and negative urine test at enrollment","Receiving B/F/TAF for ≥ 6 months prior to screening","Documented plasma HIV-1 RNA \\< 50 copies/mL for ≥ 6 months before and at screening","No resistance to GS-3242 (integrase mutation Q148H/K/R plus at least 2 of the following integrase mutations: L74I/M, T97A, E138A/K/T, or G140A/C/S) on available historical resistance reports","CD4 ≥ 200 cells/mm\\^3 at screening"],"whoShouldSkip":["Plans to breastfeed during the study period and 60 days following the last dose of study intervention","History of virologic failure while on an integrase strand-transfer inhibitor-based regimen","Creatinine clearance according to the Cockcroft-Gault formula \\< 60 mL/min"],"whatHappens":"If you join, the listed intervention(s) are B/F/TAF, GS-3242, or Lenacapavir. The registry lists allocation as randomized. Master Protocol: The main goal of this master clinical study is to measure the safety, tolerability, how well it works, and pharmacokinetic (PK) of long-acting oral (LAO) regimens in people with HIV-1 (PWH).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 125 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.395Z"},{"nctId":"NCT07842640","title":"A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection in Participants With Obesity or Overweight","officialTitle":"A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ASC35 Injection, for Subcutaneous Use (Once-monthly Formulation) in Adult Participants With Obesity or Overweight","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"TRIPLE","sponsor":"Ascletis Pharma (China) Co., Limited","sponsorClass":"INDUSTRY","summary":"This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection","conditions":["Chronic Weight Management"],"keywords":[],"interventions":[{"type":"DRUG","name":"ASC35 Injection B, for subcutaneous use"},{"type":"DRUG","name":"ASC35 Placebo Injection B, for subcutaneous use"},{"type":"DRUG","name":"Tirzepatide"}],"enrollment":84,"startDate":"2026-08-27","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Have given written informed consent to participate in this study in accordance with local regulations and the Institutional Review Boards (IRB) governing the study site.\n* Are between 18 and 65 years of age (both inclusive) at time of screening.\n* No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.\n\nExclusion Criteria:\n\n* Have evidence of any clinically significant active or chronic disease.\n* Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma.\n* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.\n* Have a history of acute or chronic pancreatitis.\n* Have a known clinically significant gastric emptying abnormality.\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.\n* Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.","locations":[{"facility":"Ascletis Clinical Site","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ascletis Recruiting","phone":"+1 2068073688","email":"clinicaltrials@ascletis.com"}],"primaryOutcomes":["Adverse events"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1: testing ASC35 Injection B, for subcutaneous use for Chronic Weight Management","inPlainEnglish":"This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection","whoItsFor":["Ages 18 Years to 65 Years","Are between 18 and 65 years of age (both inclusive) at time of screening","No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures"],"whoShouldSkip":["Have evidence of any clinically significant active or chronic disease","Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), history of ketoacidosis, or hyperosmolar state/coma","Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised","Have a history of acute or chronic pancreatitis","Have a known clinically significant gastric emptying abnormality","Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy","Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol"],"whatHappens":"If you join, the listed intervention(s) are ASC35 Injection B, for subcutaneous use, ASC35 Placebo Injection B, for subcutaneous use, or Tirzepatide. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to measure the safety, tolerability, pharmacokinetics, and pharmacodynamics of ASC35 injection","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 84 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.036Z"},{"nctId":"NCT07842835","title":"Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary CNS Lymphoma in China","officialTitle":"Registry of an Integrated Longitudinal Multimodal Biospecimen Biobank for Primary Central Nervous System Lymphoma in China（CLIMB）","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Xiaohui Ren","sponsorClass":"OTHER","summary":"This project aims to establish and prospectively register a longitudinal, multimodal biobank for primary central nervous system lymphoma (PCNSL). The study will primarily enroll patients undergoing needle biopsy or surgical resection of lesions involving the brain, spinal cord, or meninges, with a pathological diagnosis of central nervous system lymphoma. To ensure population homogeneity, patients with PCNSL will constitute the core analysis cohort. Patients with imaging findings suggestive of PCNSL but a final pathological diagnosis other than PCNSL will serve as disease controls, and matched healthy volunteers will be recruited as baseline controls.\n\nAt baseline, biopsy tissue, cerebrospinal fluid (CSF), peripheral blood, urine, saliva, and stool samples will be collected. Follow-up visits will be scheduled at 1 month after biopsy and every 3-6 months thereafter, with contrast-enhanced brain magnetic resonance imaging (MRI) and serial collection of CSF and peripheral blood. After the requirements of routine pathological diagnosis have been met, biopsy specimens will undergo tiered multi-omics profiling according to sample availability and freshness, including whole-exome sequencing, bulk RNA sequencing, single-cell RNA sequencing, metabolomics, spatial transcriptomics, and spatial metabolomics. Analyses of CSF and blood samples will focus on circulating tumor DNA and cell-free RNA (ctDNA/cfRNA), supplemented by conventional cytology, flow cytometry, and other clinical data for longitudinal disease monitoring.\n\nThe project will develop an integrated database incorporating clinical, imaging, pathological, molecular, and biospecimen data. It will characterize the relationships of baseline tissue multi-omics features and longitudinal changes in CSF- and blood-derived ctDNA/cfRNA with treatment response, recurrence prediction, and prognosis. The study will also develop diagnostic and risk-stratification models applicable to patients at our institution, across the region, and potentially throughout mainland China, while establishing standardized operating procedures for biospecimen collection and processing. This work is expected to provide high-quality evidence and a sustainable translational research platform for elucidating the biological heterogeneity of PCNSL, validating liquid-biopsy biomarkers, and optimizing precision follow-up strategies.","conditions":["Primary Central Nervous System Lymphoma (PCNSL)"],"keywords":["Primary central nervous system lymphoma","Multimodal biobank","Prospective longitudinal cohort","Liquid biopsy","Circulating tumor DNA","Cell-free RNA","Multi-omics","Recurrence prediction"],"interventions":[{"type":"DRUG","name":"High-dose methotrexate-based therapy"},{"type":"DRUG","name":"Bruton tyrosine kinase inhibitor-based therapy"}],"enrollment":400,"startDate":"2026-10-01","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"100 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* General Criteria for Patient Participants\n* Age ≥18 years.\n* Radiological findings suspicious for primary central nervous system lymphoma (PCNSL).\n* Scheduled to undergo needle biopsy or surgical resection of a lesion involving the brain, spinal cord, or meninges.\n* Willing and able to provide written informed consent.\n* Core PCNSL Cohort\n* Patient participants must additionally meet all of the following criteria:\n* Histopathologically confirmed PCNSL.\n* Able and willing to comply with scheduled study follow-up.\n* Able to undergo magnetic resonance imaging examinations.\n* Non-PCNSL Disease Control Cohort\n* Patient participants must meet the following criterion:\n* Initially suspected of having PCNSL based on imaging findings but ultimately diagnosed with a condition other than PCNSL by histopathological examination.\n* Healthy Control Cohort\n* Age ≥18 years.\n* Eligible for recruitment as a healthy control according to the study screening procedures.\n* Meets the prespecified matching requirements for the study cohorts.\n* Willing and able to provide written informed consent.\n* Additional Criteria for the Longitudinal CSF/Peripheral Blood Subcohort\n* Participants entering this subcohort must additionally meet all of the following criteria:\n* No contraindication to lumbar puncture, as determined by the study physician.\n* Willing and able to undergo serial cerebrospinal fluid and peripheral blood collection.\n* Provides separate explicit informed consent for longitudinal biospecimen collection.\n* Final eligibility for all cohorts will be determined by the study investigator based on the participant's clinical condition, pathological findings, and relevant examination results.\n\nExclusion Criteria:\n\n* Exclusion Criteria for Patient Cohorts\n* PCNSL is suspected based on imaging findings, but no definitive histopathological diagnosis can be obtained.\n* Estimated life expectancy of less than 3 months and, in the investigator's judgment, inability to complete the minimum required clinical data or biospecimen collection.\n* Refusal to provide written informed consent or withdrawal of informed consent.\n* Additional Exclusion Criteria for the Longitudinal CSF/Peripheral Blood Subcohort\n* Participants will be excluded from research lumbar puncture if any of the following conditions are present:\n* Severe coagulation disorder.\n* Marked or severe intracranial hypertension.\n* Evidence of, or substantial risk for, cerebral herniation.\n* Spinal infection or central nervous system infection.\n* Any other definite contraindication to lumbar puncture, as determined by the investigator.\n\nExclusion Criteria for Healthy Controls\n\n* Presence of a severe systemic disease.\n* Any condition that, in the investigator's judgment, makes the individual unsuitable for participation.\n* Refusal to provide written informed consent or withdrawal of informed consent.","locations":[{"facility":"Deparment of neurosurgery, Beijing tiantan hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deparment of neurosurgery, Shandong Provincial Hospital","city":"Shandong","state":"Jinan","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Deparment of neurosurgery, Tianjin huanhu hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaohui Ren, MD","phone":"+86-010-59975567","email":"xiaohuiren@mail.ccmu.edu.cn/xiaohuiren@aliyun.com"},{"name":"Haoyi Li, MD","phone":"+86-010-59975567","email":"lee_627269051@163.com"}],"primaryOutcomes":["Baseline data completeness rate","Paired tumor tissue and cerebrospinal fluid sample acquisition rate","Participant follow-up completion rate","Adherence to longitudinal cerebrospinal fluid sampling","Association between cerebrospinal fluid ctDNA clearance and MRI response","Association of baseline and longitudinal ctDNA/cfRNA status with progression-free survival"],"hasResults":false,"conditionSlugs":["lymphoma","als"],"drugSlugs":[],"locationSlugs":["beijing-china","shandong-china","tianjin-china"],"enrichment":{"headline":"Not a traditional drug phase: testing High-dose methotrexate-based therapy for Primary Central Nervous System Lymphoma (PCNSL)","inPlainEnglish":"This project aims to establish and prospectively register a longitudinal, multimodal biobank for primary central nervous system lymphoma (PCNSL). The study will primarily enroll patients undergoing needle biopsy or surgical resection of lesions involving the brain, spinal cord, or meninges, with a pathological diagnosis of central nervous system lymphoma.","whoItsFor":["Ages 18 Years to 100 Years","General Criteria for Patient Participants","Radiological findings suspicious for primary central nervous system lymphoma (PCNSL)","Scheduled to undergo needle biopsy or surgical resection of a lesion involving the brain, spinal cord, or meninges","Patient participants must additionally meet all of the following criteria:","Histopathologically confirmed PCNSL","Able to undergo magnetic resonance imaging examinations","Non-PCNSL Disease Control Cohort"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 400 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.143Z"},{"nctId":"NCT07843212","title":"Effects of SPSIP Block on Perioperative Inflammation and TLR4 in Breast Cancer Surgery","officialTitle":"Effects of Serratus Posterior Superior Intercostal Plane Block on Perioperative Inflammatory Response and TLR4-Mediated Innate Immune Activation in Breast Cancer Surgery: A Prospective, Randomized, Double-Blind, Sham-Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Mucahide Emine Fidancı Kuas","sponsorClass":"OTHER","summary":"This study will investigate whether the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.\n\nParticipants will be randomly assigned to one of two groups. One group will receive an ultrasound-guided SPSIP block, while the other group will undergo a similar procedure without active medication (sham procedure). Both groups will receive standard general anesthesia and postoperative pain management.\n\nPostoperative pain intensity, need for additional pain medication, nausea and vomiting, length of hospital stay, and persistent pain at 3 months after surgery will be assessed. Blood samples collected before surgery and at predetermined postoperative time points will be used to evaluate the body's inflammatory response to surgery and innate immune system activity. These assessments will include toll-like receptor 4 (TLR4), an immune-system marker, and selected inflammatory markers.\n\nThe main question of this study is whether the SPSIP block, compared with the sham procedure, reduces the surgery-related inflammatory response and improves postoperative pain outcomes.","conditions":["Serratus Posterior Superior Intercostal Plane Block (SPSIPB)","Breast Cancer","Toll-Like Receptors"],"keywords":["serratus posterior superior intercostal plane block","SPSIP block","postoperative pain","inflammatory response","Toll-like receptor 4","breast surgery"],"interventions":[{"type":"PROCEDURE","name":"Serratus posterior superior intercostal plane block"},{"type":"PROCEDURE","name":"Sham SPSIP Procedure"}],"enrollment":80,"startDate":"2026-06-22","completionDate":"2027-01-30","sex":"FEMALE","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Female patients aged 18 to 85 years.\n* Scheduled for elective breast cancer surgery under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I-III.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate or inability to provide informed consent.\n* Allergy or contraindication to the study local anesthetic.\n* Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia.\n* Infection at the planned injection site.\n* Pre-existing chronic pain condition or regular opioid use.\n* Inability to communicate pain scores or comply with study assessments.","locations":[{"facility":"Hitit University Erol Olçok Training and Research Hospital","city":"Çorum","state":"Çorum","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mucahide Emine Fidancı Kuas, MD","phone":"+90-553-204-9918","email":"efidanci02@gmail.com"}],"primaryOutcomes":["Change in serum TLR4 concentration from baseline to 24 hours after surgery"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["orum-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Serratus posterior superior intercostal plane block for Serratus Posterior Superior Intercostal Plane Block (SPSIPB)","inPlainEnglish":"This study will see if the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery. you would be randomly assigned to one of two groups.","whoItsFor":["Ages 18 Years to 85 Years","Women only","Female patients aged 18 to 85 years","Scheduled for elective breast cancer surgery under general anesthesia","American Society of Anesthesiologists (ASA) physical status I-III"],"whoShouldSkip":["Allergy or contraindication to the study local anesthetic","Coagulopathy or ongoing anticoagulant treatment contraindicating regional anesthesia","Infection at the planned injection site","Pre-existing chronic pain condition or regular opioid use","Inability to communicate pain scores or comply with study assessments"],"whatHappens":"If you join, the listed intervention(s) are Serratus posterior superior intercostal plane block, or Sham SPSIP Procedure. The registry lists allocation as randomized. This study will see if the serratus posterior superior intercostal plane (SPSIP) block improves postoperative recovery after breast cancer surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 80 people at Çorum. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.149Z"},{"nctId":"NCT07843485","title":"A Phase III Study to Evaluate the Efficacy and Safety of Petrelintide in Participants With Overweight or Obesity and Type 2 Diabetes","officialTitle":"A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once Weekly Petrelintide vs. Placebo in Participants With Overweight or Obesity and Type 2 Diabetes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Hoffmann-La Roche","sponsorClass":"INDUSTRY","summary":"This study will evaluate the efficacy and safety of petrelintide compared with placebo, in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and with Type 2 Diabetes (T2D).","conditions":["Obesity or Overweight","Type 2 Diabetes"],"keywords":[],"interventions":[{"type":"COMBINATION_PRODUCT","name":"Petrelintide"},{"type":"COMBINATION_PRODUCT","name":"Placebo"}],"enrollment":600,"startDate":"2026-10-09","completionDate":"2028-10-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants with BMI ≥ 27 kg/m²\n* T2D diagnosis as per World Health Organization (WHO) classification (or other locally applicable standards) with HbA1c ≥ 6.5% to ≤ 10% (48-86 mmol/mol), measured by the central laboratory at screening\n* Stable treatment with either diet and exercise alone, basal insulin, or selected oral glucose-lowering agents, for at least 90 days prior to and during screening\n* History of at least one self-reported unsuccessful dietary effort to lose body weight\n\nExclusion Criteria:\n\n* History or presence of proliferative diabetic retinopathy, or diabetic macular edema\n* Current or previous treatment with petrelintide or any other amylin analog","locations":[{"facility":"Institute for Metabolic Research Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Manassas Clinical Research Center","city":"Manassas","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: CC46369 https://forpatients.roche.com/No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Percentage Change in Body Weight from Baseline"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["los-angeles-california","manassas-virginia"],"enrichment":{"headline":"Phase 3: Petrelintide for Obesity or Overweight","inPlainEnglish":"This study will measure the how well it works and safety of petrelintide compared with dummy treatment (placebo), in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and with Type 2 Diabetes (T2D).","whoItsFor":["Ages 18 Years to any","Participants with body-mass index (BMI) ≥ 27 kg/m²","T2D diagnosis as per World Health Organization (WHO) classification (or other locally applicable standards) with HbA1c ≥ 6.5% to ≤ 10% (48-86 mmol/mol), measured by the central laboratory at screening","Stable treatment with either diet and exercise alone, basal insulin, or selected oral glucose-lowering agents, for at least 90 days prior to and during screening","History of at least one self-reported unsuccessful dietary effort to lose body weight"],"whoShouldSkip":["History or presence of proliferative diabetic retinopathy, or diabetic macular edema","Current or previous treatment with petrelintide or any other amylin analog"],"whatHappens":"If you join, the listed intervention(s) are Petrelintide, or Placebo. The registry lists allocation as randomized. This study will measure the how well it works and safety of petrelintide compared with dummy treatment (placebo), in conjunction with a reduced-calorie diet and increased physical activity, for weight management in participants living with overweight or obesity and with Type 2 Diabetes (T2D).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 600 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.526Z"},{"nctId":"NCT07843602","title":"Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR","officialTitle":"The Effect of Cyclic Sighing Breathing Exercise on Catheter-Related Bladder Discomfort, Pain, and Sleep Quality in Patients Undergoing Transurethral Resection: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Mersin University","sponsorClass":"OTHER","summary":"Transurethral resection (TUR) is a common minimally invasive surgical procedure for lower urinary tract diseases. However, postoperative urinary catheterization often causes catheter-related bladder discomfort (CRBD) and pain due to bladder spasms, which negatively impact recovery and sleep quality. Pharmacological agents used to alleviate CRBD and pain may cause adverse side effects. This study aims to evaluate the effects of cyclic sighing breathing exercises on CRBD severity, pain intensity, and sleep quality in patients undergoing TUR.","conditions":["Transurethral Resection of Bladder Tumor","Transurethral Resection of the Prostate (TURP)","Transurethral Resection of the Bladder"],"keywords":["Sleep quality","Transurethral resection","Breathing exercises","pain","Urinary catheterization"],"interventions":[{"type":"OTHER","name":"Cyclic Sighing Breathing Exercise"}],"enrollment":76,"startDate":"2026-11-05","completionDate":"2027-02-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18 years or older\n* Undergoing Transurethral Resection of the Prostate (TUR-P) or Transurethral Resection of Bladder Tumor (TUR-M/TUR-BT)\n* Having an indwelling urethral catheter placed postoperatively\n* Fully conscious, oriented, and cooperative\n* Able to speak and understand Turkish\n* Volunteering to participate and providing written informed consent\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status score of IV or higher\n* Presence of any medical condition or physical impairment that prevents performing breathing exercises\n* Diagnosed history of sleep apnea\n* Regular use of sedative, hypnotic, or sleep-inducing medications\n* Neurological or psychiatric disorders severely impeding hearing, vision, or verbal communication\n* Refusal to participate in the study","locations":[{"facility":"Hatay Iskenderun State Hospital","city":"Hatay","state":"","country":"Turkey (Türkiye)","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Iskenderun State Hospital","city":"Hatay","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hasan Şeren","phone":"+903266153750","email":"hasanseren94@gmail.com"},{"name":"Hasan Şeren","phone":"","email":""}],"primaryOutcomes":["Catheter-Related Bladder Discomfort (CRBD) Severity Score"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["hatay-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Cyclic Sighing Breathing Exercise for Transurethral Resection of Bladder Tumor","inPlainEnglish":"Transurethral resection (TUR) is a common minimally invasive surgical procedure for lower urinary tract diseases. However, postoperative urinary catheterization often causes catheter-related bladder discomfort (CRBD) and pain due to bladder spasms, which negatively impact recovery and sleep quality.","whoItsFor":["Ages 18 Years to any","Aged 18 years or older","Undergoing Transurethral Resection of the Prostate (TUR-P) or Transurethral Resection of Bladder Tumor (TUR-M/TUR-BT)","Having an indwelling urethral catheter placed postoperatively","Fully conscious, oriented, and cooperative","Able to speak and understand Turkish"],"whoShouldSkip":["American Society of Anesthesiologists (ASA) physical status score of IV or higher","Presence of any medical condition or physical impairment that prevents performing breathing exercises","Diagnosed history of sleep apnea","Regular use of sedative, hypnotic, or sleep-inducing medications","Neurological or psychiatric disorders severely impeding hearing, vision, or verbal communication","Refusal to participate in the study"],"whatHappens":"If you join, the listed intervention(s) are Cyclic Sighing Breathing Exercise. The registry lists allocation as randomized. Transurethral resection (TUR) is a common minimally invasive surgical procedure for lower urinary tract diseases.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 76 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.317Z"},{"nctId":"NCT07843940","title":"A Study to Test Obrixtamig in Combination With Pumitamig in People With Advanced Small Cell Lung Cancer (Dareon®-Rosetta35)","officialTitle":"A Phase Ib/II, Open-label, Safety and Tolerability Trial of Intravenous Obrixtamig in Combination With Pumitamig and Standard of Care (Carboplatin, Etoposide) in Patients With Extensive-stage Small Cell Lung Carcinoma","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with extensive-stage small cell lung cancer. The purpose of this study is to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig. Another purpose is to check whether the combination study treatment can make tumours shrink. Obrixtamig and pumitamig are being developed to help the immune system fight cancer.\n\nParticipants are put into 2 groups. One group gets obrixtamig and pumitamig. The other group gets obrixtamig and pumitamig with standard chemotherapy (carboplatin and etoposide). All study treatments are given as infusions into a vein.\n\nThis study does not have a fixed duration. Participants can receive obrixtamig and pumitamig for up to 2 years if they benefit from treatment and can tolerate it. Participants visit the study site regularly, with some overnight stays required. During this time, doctors regularly check for health problems that could be caused by the study treatment. They also monitor the size of the tumour(s) and take laboratory tests.","conditions":["Extensive-stage Small Cell Lung Carcinoma","Advanced Small Cell Lung Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"Obrixtamig"},{"type":"DRUG","name":"Pumitamig"},{"type":"DRUG","name":"Carboplatin"},{"type":"DRUG","name":"Etoposide"}],"enrollment":55,"startDate":"2026-10-01","completionDate":"2030-04-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to any trial-specific procedures, sampling, or analyses.\n2. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the Informed Consent Form (ICF).\n3. Willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, laboratory tests, restrictions regarding prohibited medications, lifestyle restrictions, and other requirements related to the trial. This includes that they are able to understand and follow trial-related instructions.\n4. Histologically or cytologically confirmed Extensive Stage Small Cell Lung Carcinoma (ES-SCLC) \\[using the AJCC (American Joint Committee on Cancer) tumour node metastasis staging system combined with Veterans Administration Lung Study Group (VALG)'s two stage classification scheme\\].\n5. Prior systemic anti-cancer treatment for ES-SCLC:\n\n   * For Cohort 1 - must have received at least one line of platinum-containing treatment but no more than 2 lines of treatment per local standard of care for the treatment of ES-SCLC.\n   * For Cohort 2 - must have received no prior systemic therapy for ES-SCLC. Participants with prior chemoradiotherapy for limited stage (LS)-SCLC must have been treated with curative intent and had a treatment-free interval of at least 6 months after the last chemotherapy, radiotherapy, or chemoradiotherapy before diagnosis of ES-SCLC to be eligible.\n6. At least one measurable lesion outside of the Central Nervous System (CNS) as defined per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. Previously treated lesions after local therapy (radiotherapy, ablation, interventional procedures, etc.) are generally not considered target lesions. If the lesion with prior local treatment is the only measurable lesion, radiologic evidence must be provided to demonstrate disease progression for selection as target lesion (an isolated blastic bone metastasis or a singular central nervous system metastasis should not be considered as a measurable lesion).\n7. Availability of an archival tumour sample (except China).\n8. Adequate organ function. Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Serious concomitant disease or medical condition such as neurologic, psychiatric (including substance use disorder), active ulcers (gastrointestinal tract or skin) or laboratory abnormalities that may negatively impact patient safety during trial participation, affect compliance with trial requirements or invalidate assessments relevant for the investigation of the safety and preliminary efficacy of the investigational drugs.\n2. Histologically or cytologically confirmed SCLC with combined histology, diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma or neuroendocrine prostate cancer.\n3. Presence of leptomeningeal disease and/or carcinomatous meningitis.\n4. Known hypersensitivity to the trial drugs or their excipients, prior severe, life-threatening hypersensitivity reaction(s) to monoclonal antibodies, or significant risk of allergic or anaphylactic reaction(s) to any of the investigated drug products according to the investigator's judgement.\n5. Participants who experienced severe, life-threatening immune-mediated adverse events, e.g. serious Grade 3 or higher immune-mediated adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents.\n6. Persistent toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia, asthenia/fatigue, amenorrhea/menstrual disorders, CTCAE Grade 2 peripheral neuropathy, and CTCAE Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per investigator judgment).\n7. Prior organ or tissue allograft.\n8. History of or active interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade) or any other condition resulting in significant impairment in lung function.\n\nFurther exclusion criteria apply.","locations":[{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Dana-Farber Cancer Institute","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"START New Jersey","city":"East Brunswick","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"New York University Langone Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"SCRI Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chris Obrien Lifehouse","city":"Camperdown","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Townsville University Hospital","city":"Douglas","state":"Queensland","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cliniques Universitaires Saint-Luc","city":"Brussels","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Gent","city":"Ghent","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Cancer Hospital","city":"Chengdu","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Harbin Medical University Cancer Hospital","city":"Harbin","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Chest Hospital","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CTR Leon Berard","city":"Lyon","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"HOP Timone","city":"Marseille","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Technische Universität Dresden","city":"Dresden","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Essen AöR","city":"Essen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Tübingen","city":"Tübingen","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Okayama University Hospital","city":"Okayama, Okayama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Osaka, Hirakata","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shizuoka Cancer Center","city":"Shizuoka, Sunto-gun","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Medisch Centrum Groningen","city":"Groningen","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza","city":"Brzozów","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lower Silesian Oncology Centre","city":"Wroclaw","state":"","country":"Poland","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario 12 de Octubre","city":"Madrid","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico De Valencia (INCLIVA)","city":"Valencia","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-0127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation or dose modification"],"hasResults":false,"conditionSlugs":["lung-cancer","als"],"drugSlugs":[],"locationSlugs":["miami-florida","boston-massachusetts","east-brunswick-new-jersey","new-york-new-york","nashville-tennessee","camperdown-australia","douglas-australia","brussels-belgium","ghent-belgium","chengdu-china","harbin-china","shanghai-china","lyon-france","marseille-france","villejuif-france","dresden-germany","essen-germany","t-bingen-germany","okayama-okayama-japan","osaka-hirakata-japan","shizuoka-sunto-gun-japan","groningen-netherlands","brzoz-w-poland","wroclaw-poland","barcelona-spain","madrid-spain","valencia-spain"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Obrixtamig for Extensive-stage Small Cell Lung Carcinoma","inPlainEnglish":"This study is open to adults with extensive-stage small cell lung cancer. this study wants to find out how well people with this type of cancer tolerate taking study medicines called obrixtamig and pumitamig.","whoItsFor":["Ages 18 Years to any","Prior systemic anti-cancer treatment for ES-SCLC:","For Cohort 1 - must have received at least one line of platinum-containing treatment but no more than 2 lines of treatment per local standard of care for the treatment of ES-SCLC","Availability of an archival tumour sample (except China)","Adequate organ function. Further who can join apply"],"whoShouldSkip":["Histologically or cytologically confirmed SCLC with combined histology, diagnosis of Merkel cell carcinoma, medullary thyroid carcinoma or neuroendocrine prostate cancer","Presence of leptomeningeal disease and/or carcinomatous meningitis","Participants who experienced severe, life-threatening immune-mediated side effects, e.g. serious Grade 3 or higher immune-mediated adverse event (imAE) or infusion-related reactions, that led to permanent discontinuation while on treatment with immuno-oncology agents","Prior organ or tissue allograft","History of or active interstitial lung disease, pulmonary fibrosis, organizing pneumonia or non-infectious pneumonitis (any grade) or any other condition resulting in significant impairment in lung function"],"whatHappens":"If you join, the listed intervention(s) are Obrixtamig, Pumitamig, or Carboplatin. The registry lists allocation as randomized. This study is open to adults with extensive-stage small cell lung cancer.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 55 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.728Z"},{"nctId":"NCT07844434","title":"AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG","officialTitle":"Prospective Observational Comparative Pilot Study to Evaluate Performance of an AI-based Cardiac Disease Analysis Algorithm Using Standard 12-lead ECG and Single-lead ECG Data","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Inha University Hospital","sponsorClass":"OTHER","summary":"This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters. The study will prospectively enroll eligible participants to gather real-world clinical data, contributing to enhanced diagnostic accuracy and patient management.","conditions":["Heart Failure","Atrial Fibrillation (AF)","Electrocardiogram"],"keywords":["Artificial Intelligence","Electrocardiogram","Heart Failure","Left Ventricular Dysfunction","Atrial Fibrillation","Pilot Study"],"interventions":[{"type":"DEVICE","name":"SmartECG-EF"}],"enrollment":300,"startDate":"2026-11-10","completionDate":"2027-08-30","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent provided voluntarily by the subject\n* Age ≥ 19 years\n* Patients who undergo standard 12-lead ECG measurement during the study period\n* Subjects with sinus rhythm on ECG at the time of examination\n* Subjects available for additional 1-lead ECG measurement during the same visit\n\nExclusion Criteria:\n\n* Subjects deemed inappropriate or unlikely to comply with the study requirements by the investigator\n* Patients with atrial fibrillation or atrial flutter on ECG at the time of examination\n* Patients with pacing rhythm due to a pacemaker\n* Subjects with severe tremor, uncooperativity, or skin conditions that make 1-lead ECG measurement difficult\n* Subjects whose additional study measurements would delay standard medical care due to a critical medical condition\n* Withdrawal of consent or refusal to agree to personal information usage\n* ECG with sub-standard quality (unanalyzable noise, lead disconnection, etc.; note: unanalyzable rate evaluation can be recorded separately)","locations":[{"facility":"Inha University Hospital","city":"Incheon","state":"Incheon","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yongsoo Baek, M.D., Ph.D.","phone":"+82-32-890-2200","email":"existsoo@inha.ac.kr"}],"primaryOutcomes":["Correlation and Agreement between 12-Lead and 1-Lead AI Scores"],"hasResults":false,"conditionSlugs":["heart-failure","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["incheon-south-korea"],"enrichment":{"headline":"Not a traditional drug phase: SmartECG-EF for Heart Failure","inPlainEnglish":"This pilot study is designed to measure the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital. The primary objective is to assess how effectively the device assists clinicians in evaluating cardiac function and related clinical parameters.","whoItsFor":["Ages 19 Years to any","Patients who undergo standard 12-lead ECG measurement during the study period","Subjects with sinus rhythm on ECG at the time of examination","Subjects available for additional 1-lead ECG measurement during the same visit"],"whoShouldSkip":["Subjects deemed inappropriate or unlikely to comply with the study requirements by the investigator","Patients with atrial fibrillation or atrial flutter on ECG at the time of examination","Patients with pacing rhythm due to a pacemaker","Subjects with severe tremor, uncooperativity, or skin conditions that make 1-lead ECG measurement difficult","Subjects whose additional study measurements would delay standard medical care due to a critical medical condition","Withdrawal of consent or refusal to agree to personal information usage","ECG with sub-standard quality (unanalyzable noise, lead disconnection, etc.; note: unanalyzable rate evaluation can be recorded separately)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Incheon. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.746Z"},{"nctId":"NCT07844590","title":"Developing New Ways to Detect Respiratory Impairment Early in ALS","officialTitle":"Early Detection of Respiratory Impairments in ALS: A Novel Diagnostic Approach","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Thomas Jefferson University","sponsorClass":"OTHER","summary":"The goal of this observational study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can identify early signs of ALS before major physical changes occur.\n\nThe main questions the study aims to answer are:\n\n* Can changes in automatic breathing help identify early ALS-related changes?\n* Can breathing measures distinguish people with ALS from people without ALS?\n* Do people with genetic risk for ALS who show changes in breathing also have changes in the brainstem and spinal cord or higher levels of blood markers associated with nerve damage?\n\nParticipants will complete breathing and muscle function tests, an MRI scan of the brainstem and spinal cord, and blood testing. The study will include people with ALS, people with genetic risk for ALS who do not yet have symptoms, and healthy adults for comparison.","conditions":["Amyotrophic Lateral Sclerosis (ALS)"],"keywords":["Amyotrophic lateral sclerosis","Early diagnosis","Respiratory function","Respiratory impairment","Respiratory biomarkers","Biomarkers","Neuroimaging","Magnetic resonance imaging","Brainstem","Spinal cord","Neurofilament light chain","Genetic risk","Presymptomatic amyotrophic lateral sclerosis","Motor neuron disease","Respiratory muscle function","Lou Gehrig's disease","automatic breathing","respiratory control","respiratory weakness","respiratory muscle strength","pulmonary function","respiratory drive","hypoxic","hypercapnic","Surface electromyography"],"interventions":[],"enrollment":70,"startDate":"2026-09","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Symptomatic participants with ALS must have an ALS Functional Rating Scale-Revised (ALSFRS-R) score of 47/48 or less at the time of recruitment.\n* Asymptomatic/presymptomatic participants must have a pathogenic C9orf72 expansion of at least 25 repeats or a similar genetic abnormality known to be associated with ALS.\n* Healthy control participants must have no clinically identifiable neurological deficits based on medical history and screening. -\n\nExclusion Criteria:\n\n* Any safety concern or contraindication to MRI based on MRI safety screening.\n* Healthy control participants who do not pass the neurological screening.\n* Pregnancy.\n* Metal implants above the waist, including cardiac pacemakers or brain, neck, cervical, or thoracic implants.\n* Neurocognitive impairment.\n* Inability or unwillingness to provide informed consent.\n* Younger than 18 years of age.","locations":[{"facility":"Thomas Jefferson University - Center City","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jayakrishnan Nair, PhD, PT","phone":"352-871-5888","email":"Jayakrishnan.Nair@jefferson.edu"},{"name":"Dana Johnson, DPT","phone":"215-326-9153","email":"dana.johnson@jefferson.edu"}],"primaryOutcomes":["Diagnostic Accuracy of the Automatic Breathing Impairment Risk Score (P0.1 + Chemosensitivity) for Detecting ALS-Related Respiratory Dysfunction"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Developing New Ways to Detect Respiratory Impairment Early in ALS","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to develop new ways to detect early changes associated with amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The study will examine whether changes in breathing, magnetic resonance imaging (MRI) of the brainstem and spinal cord, and blood markers can identify early signs of ALS before major physical changes occur.","whoItsFor":["Ages 18 Years to any","Symptomatic participants with ALS must have an ALS Functional Rating Scale-Revised (ALSFRS-R) score of 47/48 or less at the time of recruitment","Asymptomatic/presymptomatic participants must have a pathogenic C9orf72 expansion of at least 25 repeats or a similar genetic abnormality known to be associated with ALS","Healthy control participants must have no clinically identifiable neurological deficits based on medical history and screening. -"],"whoShouldSkip":["Any safety concern or contraindication to MRI based on MRI safety screening","Healthy control participants who do not pass the neurological screening","Metal implants above the waist, including cardiac pacemakers or brain, neck, cervical, or thoracic implants","Neurocognitive impairment","Younger than 18 years of age"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 70 people at Philadelphia. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.621Z"},{"nctId":"NCT07845500","title":"A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity","officialTitle":"A PHASE 3 STUDY TO EVALUATE THE SWITCH TO MONTHLY BEROBENATIDE FOR MAINTAINING WEIGHT IN ADULTS WHO ARE ON WEEKLY SEMAGLUTIDE OR TIRZEPATIDE (VESPER-SWITCH)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.\n\nParticipants will be in the study for about 11 months.","conditions":["Obesity","Overweight and/or Obesity","Overweight","Treatment Of Obesity"],"keywords":["nutrition disorder"],"interventions":[{"type":"DRUG","name":"Semaglutide"},{"type":"DRUG","name":"Berobenatide"},{"type":"DRUG","name":"Tirzepatide"}],"enrollment":660,"startDate":"2026-09-30","completionDate":"2028-02-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥18 years.\n* Currently taking semaglutide or tirzepatide for obesity management.\n\nExclusion Criteria:\n\n* Diagnosis of any form of diabetes.\n* History of acute or chronic pancreatitis.\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2).","locations":[{"facility":"University of Alabama at Birmingham","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"San Fernando Valley Health Institute","city":"Canoga Park","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research - Los Angeles","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research Sacramento","city":"Sacramento","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Southern California Clinical Research","city":"Santa Ana","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Diablo Clinical Research, LLC dba Flourish Research","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern California Retina Specialists","city":"West Hills","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westside Center for Clinical Research","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jacksonville Center for Clinical Research","city":"Jacksonville","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Suncoast Clinical Research","city":"New Port Richey","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oviedo Medical Research","city":"Oviedo","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Diabetes, Obesity and Metabolism Inc","city":"Pembroke Pines","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"MediSphere Medical Research Center, LLC","city":"Evansville","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Louisville","state":"Kentucky","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Aa Mrc Llc","city":"Flint","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"SKY Integrative Medical Center/SKYCRNG","city":"Ridgeland","state":"Mississippi","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Professionals","city":"Chesterfield","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercury Street Medical Group, PLLC","city":"Butte","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Medication Management, LLC","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Wilmington","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Mt. Auburn","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tribe Clinical Research, LLC","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"York Clinical Research, LLC","city":"Norfolk","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emeritus Research Sydney","city":"Botany","state":"New South Wales","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emeritus Research Camberwell","city":"Camberwell","state":"Victoria","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Percent change from baseline in body weight"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["birmingham-alabama","canoga-park-california","los-angeles-california","sacramento-california","santa-ana-california","walnut-creek-california","west-hills-california","jacksonville-florida","new-port-richey-florida","oviedo-florida","pembroke-pines-florida","evansville-indiana","louisville-kentucky","flint-michigan","ridgeland-mississippi","chesterfield-missouri","butte-montana","greensboro-north-carolina","monroe-north-carolina","wilmington-north-carolina","cincinnati-ohio","greenville-south-carolina","norfolk-virginia","botany-australia","camberwell-australia"],"enrichment":{"headline":"Phase 3: testing Semaglutide for Obesity","inPlainEnglish":"This study wants to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide. The study does not include people with diabetes.","whoItsFor":["Ages 18 Years to any","Currently taking semaglutide or tirzepatide for obesity management"],"whoShouldSkip":["Diagnosis of any form of diabetes","History of acute or chronic pancreatitis","Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN-2)"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide, Berobenatide, or Tirzepatide. The registry lists allocation as randomized. This study wants to learn about the safety and effectiveness of berobenatide in adults with overweight or obesity who have already lost weight while taking semaglutide or tirzepatide.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 660 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.722Z"},{"nctId":"NCT07845604","title":"Precision Depression Adalimumab Trial","officialTitle":"An Precision Immunopsychiatric Pharmacological Probe of Adalimumab as an Anti-depressant","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Daniel Moriarity","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (MDD) who are already taking the anti-depressant medication Lexapro (escitalopram).\n\nThe main questions it aims to answer are:\n\n1. Does adalimumab improve the symptoms of some patients with MDD who are already taking an anti-depressant?\n2. What characteristics predict for whom adalimumab has anti-depressant properties.\n\nResearchers will compare adalimumab to a placebo (a look-alike substance that contains no drug) to see if adalimumab works to improve depressive symptoms as an add-on drug to the anti-depressant Lexapro (escitalopram).\n\nFor these primary aims the participants will:\n\n1. Visit the clinic once every 2 weeks for a checkups and injection of adalimumab or placebo from the study psychiatrist (Day 1, 15, 29, and 43 for injections)\n2. Complete short (\\<5 min) daily surveys for the 57 day duration of the study.","conditions":["Major Depressive Disorder (MDD)"],"keywords":["inflammation","depression","psychoneuroimmunology","intensive longitudinal study"],"interventions":[{"type":"DRUG","name":"Adalimumab Biosimilars Injection"},{"type":"OTHER","name":"Placebo"}],"enrollment":60,"startDate":"2026-09","completionDate":"2031-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or female, aged 18+ years\n* Meet DSM-5 criteria for Major Depressive Disorder\n* baseline serum TNF-alpha (average of two samples in the same week) greater than 1.5 pg/mL\n* Taking a steady dose of Lexapro (escitalopram) for at least 4 weeks\n* Ability to take oral medication and physician-administered subcutaneous injection and be willing to adhere to the study protocol\n* For females of reproductive potential: use of highly effective contraception for at least 1 month\n* Access to a phone or computer with a camera\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding\n2. Active, chronic or recurrent infection\n3. Known malignancy\n4. Current use of immune modulating medications\n5. Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS)\n6. History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB)\n7. Congestive heart failure\n8. History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome)\n9. History of seizure disorder\n10. Symptomatic hyponatremia\n11. Monoamine oxidase inhibitors (MAOI) use within 14 days\n12. Recent use of Rituxan (rituximab)\n13. Concomitant use of:\n\n    1. Immunosuppressants\n    2. Kineret (anakinra)\n    3. Orencia (abatacept)\n    4. Remicade (infliximab)\n    5. Enbrel (etanercept)\n    6. Cimzia (certolizumab pegol)\n    7. Simponi (golimumab)\n    8. Imuran (azathioprine)\n    9. Purinethol (6-mercaptopurine)\n    10. Linezolid\n    11. IV methylene blue\n    12. Pimozide\n    13. Antiplatelet agents\n    14. Strong anticoagulants (e.g. warfarin, large doses of NSAIDs)\n    15. Other SSRIs, SNRIs, tryptophan\n14. Clinically relevant substance use disorder\n15. Known allergic reactions to components of adalimumab and/or escitalopram\n16. Treatment with another investigational drug or other intervention while participating in the study","locations":[{"facility":"University of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel P Moriarity, PhD","phone":"(484) 808-5930","email":"dmori@upenn.edu"}],"primaryOutcomes":["Change from baseline in individual somatic, affective, and motivational depressive symptoms, as measured by the Quick Inventory of Depressive Symptomatology (QIDS)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["adalimumab"],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Phase 2: testing Adalimumab Biosimilars Injection for Major Depressive Disorder (MDD)","inPlainEnglish":"The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (major depression) who are already taking the anti-depressant medication Lexapro (escitalopram). The main questions it aims to answer are: 1.","whoItsFor":["Ages 18 Years to any","Stated willingness to comply with all study procedures and availability for the duration of the study","Male or female, aged 18+ years","Meet DSM-5 criteria for Major Depressive Disorder","baseline serum TNF-alpha (average of two samples in the same week) greater than 1.5 pg/mL","Taking a steady dose of Lexapro (escitalopram) for at least 4 weeks","Ability to take oral medication and physician-administered subcutaneous injection and be willing to adhere to the study protocol","For females of reproductive potential: use of highly effective contraception for at least 1 month"],"whoShouldSkip":["Pregnant or breastfeeding","Active, chronic or recurrent infection","Current use of immune modulating medications","Immunocompromised, current autoimmune condition or history of severe immune condition (e.g., history of cancer, HIV/AIDS)","History of, or positive test for, Hepatitis B surface antigen or core antibody positivity or tuberculosis (TB)","Congestive heart failure","History of demyelinating disease (multiple sclerosis (MS), optic neuritis, Guillain-Barre syndrome)"],"whatHappens":"If you join, the listed intervention(s) are Adalimumab Biosimilars Injection, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if the anti-inflammatory medication adalimumab improves depressive symptoms in adults with Major Depressive Disorder (major depression) who are already taking the anti-depressant medication Lexapro (escitalopram).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.265Z"},{"nctId":"NCT07845630","title":"A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body","officialTitle":"Bioequivalence of Two Different Vicadrostat / Empagliflozin Formulations Following Oral Administration in Healthy Trial Participants (an Open-label, Randomised, Single-dose, Two-period, Two-sequence Crossover Trial)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.","conditions":["Healthy"],"keywords":[],"interventions":[{"type":"DRUG","name":"Vicadrostat"},{"type":"DRUG","name":"Empagliflozin"},{"type":"DRUG","name":"Vicadrostat + empagliflozin"}],"enrollment":36,"startDate":"2026-10-14","completionDate":"2026-12-11","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests\n2. Age of 18 to 55 years (inclusive)\n3. Body mass index of 18.5 to 29.9 kg / m\\^2 (inclusive)\n4. Signed and dated written informed consent in accordance with International Council for Harmonisation - Good Clinical Practice and local legislation prior to admission to the trial\n5. Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator\n2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm\n3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance\n4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator\n5. Further exclusion criteria apply.","locations":[{"facility":"Humanpharmakologisches Zentrum Biberach","city":"Biberach","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"1-800-243-0127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)","Maximum measured concentration of the analyte in plasma (Cmax)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["empagliflozin"],"locationSlugs":["biberach-germany"],"enrichment":{"headline":"Phase 1: testing Vicadrostat for Healthy","inPlainEnglish":"The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.","whoItsFor":["Ages 18 Years to 55 Years","Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (Blood pressure, Pulse rate), 12-lead Electrocardiogram, and clinical laboratory tests","Age of 18 to 55 years (inclusive)","Body mass index of 18.5 to 29.9 kg / m\\^2 (inclusive)","Further who can join apply"],"whoShouldSkip":["Any finding in the medical examination (including Blood pressure, Pulse rate or Electrocardiogram) deviating from normal and assessed as clinically relevant by the investigator","Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm","Any laboratory value outside the reference range that the investigator considers to be of clinical relevance","Any evidence of a concomitant disease assessed as clinically relevant by the investigator"],"whatHappens":"If you join, the listed intervention(s) are Vicadrostat, Empagliflozin, or Vicadrostat + empagliflozin. The registry lists allocation as randomized. The main objective of this trial is to establish the bioequivalence of two different formulations of vicadrostat / empagliflozin in healthy male and female trial participants following oral administration.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at Biberach. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.606Z"},{"nctId":"NCT07845682","title":"A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With TRUPULSE™ Generator in Persistent Atrial Fibrillation","officialTitle":"A Prospective, Multicenter, Single Arm With Performance Goal Study to Evaluate Safety and Effectiveness of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator in Persistent Atrial Fibrillation (PsAF)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Biosense Webster, Inc.","sponsorClass":"INDUSTRY","summary":"This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).","conditions":["Atrial Fibrillation"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Radiofrequency/Pulsed Field Ablation"}],"enrollment":150,"startDate":"2026-10-14","completionDate":"2028-04-17","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Documented symptomatic persistent atrial fibrillation (AF), which is defined as continuous AF that sustains beyond 7 days and less than 1 year and is documented by the following: Physician's note indicating continuous AF greater than or equal to (\\>=) 7 days but no more than 1 year; AND 1) Two electrocardiograms (from any forms of rhythm monitoring) showing continuous AF, with electrocardiogram taken at least 7 days apart (electrograms cannot \\>12 months prior to enrollment) OR 2) At least 24-hour Holter/ telemetry strip within 12 months prior to enrollment showing continuous AF\n* Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD\n* Age 18-80 years\n* Willing and capable of providing consent\n* Able and willing to comply with all pre-, post- and follow-up testing and requirement\n\nExclusion criteria:\n\n* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)\n* Documented severe dilatation of the left atrium (LA) (LAD \\>50 millimetre \\[mm\\]) antero-posterior diameter on imaging within 6 months prior to procedure\n* Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than \\[\\<\\] 40 percent \\[%\\]) by imaging within 6 months prior to procedure\n* Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume \\>=60 millilitre (mL)/beat, Regurgitant fraction \\>=50%, and/or effective regurgitant orifice area \\>=0.40 square centimetre (cm\\^2).\n* Moderate-severe, severe tricuspid valve regurgitation or insufficiency\n* Documented LA thrombus by imaging within 48 hours of the procedure or by intracardiac echocardiography (ICE) prior to transeptal puncture during procedure\n* Concomitant other arrhythmia, including: atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-Whiteexcept cavotricuspid isthmus (CTI) lines for the ablation of typical right atrial flutter\n* Previous LA ablation or surgery\n* Valvular cardiac surgical/percutaneous procedure (that is, ventriculotomy, atriotomy, valve repair or replacement and presence of a prosthetic valve)\n* Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months\n* Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV\n* History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, etcetera)\n* Documented thromboembolic event (including transient ischemic attack \\[TIA\\]) within the past 12 months\n* History of a documented symptomatic lacunar infarction within the past 12 months\n* Participants with percutaneous coronary intervention or acute myocardial infarction within 3 months\n* Coronary artery bypass grafting (CABG) surgery within the past 6 months (180 days)\n* Unstable angina within the past 6 months\n* Significant pulmonary disease (for example, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms\n* Significant congenital anomaly (for example, american society for dermatologic surgery \\[ASDs\\]) including treated or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation\n* Presence of a condition that precludes vascular access\n* Prior diagnosis of pulmonary vein stenosis\n* Pre-existing hemi diaphragmatic paralysis\n* Acute illness, active systemic infection, or sepsis\n* Participant has an implanted metal cardiac device, including MitraClip and left atrial appendage occlusion (LAAO) devices (for example, WATCHMAN, Amulet, etcetera) (this exclusion does not include coronary stents, implanted pacemakers, implantable cardioverter-defibrillators \\[ICD\\] and implantable loop recorders \\[ILR\\])\n* Current enrollment in an investigational study evaluating another device or drug\n* Women who are pregnant (as evidenced by pregnancy test if pre- menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation\n* Life expectancy less than 12 months\n* History of massive haemorrhage within the past 6 months\n* Those considered by the investigators as not suitable for participating in this clinical study","locations":[{"facility":"Beijing Anzhen Hospital, Capital Medical University","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Qilu Hospital of Shandong University","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangsu Province Hospital","city":"Nanjing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Shanghai Chest Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yun Bai","phone":"+86 15810492554","email":"ybai8@its.jnj.com"}],"primaryOutcomes":["Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia Episodes","Occurrence of Early Onset Primary Adverse Event (PAE)"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["beijing-china","jinan-china","nanjing-china","shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: Radiofrequency/Pulsed Field Ablation for Atrial Fibrillation","inPlainEnglish":"This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).","whoItsFor":["Ages 18 Years to 80 Years","Failed at least one (1) antiarrhythmic drug (AAD) (Class I or Class III) as evidenced by recurrent symptomatic AF, intolerable to the AAD","Willing and capable of providing consent"],"whoShouldSkip":["AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (for example, documented obstructive sleep apnea, acute alcohol toxicity, etcetera)","Documented severe dilatation of the left atrium (LA) (LAD \\>50 millimetre \\[mm\\]) antero-posterior diameter on imaging within 6 months prior to procedure","Documented severely compromised left ventricular ejection fraction (LVEF) (LVEF less than \\[\\<\\] 40 percent \\[%\\]) by imaging within 6 months prior to procedure","Severe mitral regurgitation or insufficiency, or the report claims: Regurgitant volume \\>=60 millilitre (mL)/beat, Regurgitant fraction \\>=50%, and/or effective regurgitant orifice area \\>=0.40 square centimetre (cm\\^2)","Moderate-severe, severe tricuspid valve regurgitation or insufficiency","Documented LA thrombus by imaging within 48 hours of the procedure or by intracardiac echocardiography (ICE) prior to transeptal puncture during procedure","Previous LA ablation or surgery"],"whatHappens":"If you join, the listed intervention(s) are Radiofrequency/Pulsed Field Ablation. The registry lists allocation as na. This purpose of this study is to understand how safe Biosense Webster Pulsed Field (PF)/Radiofrequency (RF) ablation system is and how well it works over 12 months in participants with persistent atrial fibrillation (PsAF; abnormal heart signals that cause irregular heartbeats).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 150 people at 4 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.741Z"},{"nctId":"NCT07845695","title":"Preoperative Music Intervention for Anxiety in Hip and Knee Arthroplasty","officialTitle":"Does Listening to Music Immediately Before Hip and Knee Arthroplasty Significantly Decrease Peri-op Anxiety and Related Outcomes?","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Columbia University","sponsorClass":"OTHER","summary":"Many patients feel anxious before joint replacement surgery. This anxiety is common - affecting roughly 1 in 3 patients - and research has shown that patients who are more anxious before surgery tend to have more pain afterward and may need more pain medication during recovery. Listening to music before medical procedures has been shown to reduce anxiety in many types of surgery. In fact, a recent analysis of 20 studies found that music works about as well as anti-anxiety medication for calming patients before surgery, with about 1 in 4 patients experiencing a meaningful benefit. However, almost all of this research has been done in other types of surgery. No study has specifically tested whether letting patients listen to their own preferred music before hip or knee replacement surgery reduces their anxiety.\n\nThis study will randomly assign 52 patients scheduled for hip or knee replacement surgery to one of two groups: one group will listen to music of their choice through noise-cancelling headphones while waiting for surgery (for at least 20 minutes), and the other group will receive the usual preoperative care without music. Patients will fill out a brief 6-question anxiety survey when they arrive in the preoperative area and again just before being taken to the operating room. The study will also ask patients about their pain, anxiety, and overall experience after surgery, and will review their medical charts to see how much sedation and pain medication was used during the procedure. If music is shown to reduce anxiety in this setting, it could be easily adopted by any hospital at very low cost, offering patients a simple, drug-free way to feel calmer before their surgery.","conditions":["Anxiety","Osteoarthritis"],"keywords":[],"interventions":[{"type":"OTHER","name":"Music via Headphones"}],"enrollment":52,"startDate":"2026-09-22","completionDate":"2027-03-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults 18 years or older undergoing primary THA, TKA, or UKA for osteoarthritis\n* Planned spinal/regional anesthesia\n* Willingness to undergo randomization\n* Ability to provide informed consent in English\n\nExclusion Criteria:\n\n* Chronic opioid use prior to surgery\n* Revision TJA\n* Primary diagnosis other than osteoarthritis (e.g., fracture, posttraumatic arthritis, AVN)\n* Hearing impairment precluding music listening\n* Active psychiatric disorder requiring current pharmacotherapy\n* Pregnancy\n* Inability to provide informed consent in English","locations":[{"facility":"Columbia University Irving Medical Center - Milstein Hospital","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rishi Vas","phone":"214-603-1931","email":"rkv2107@cumc.columbia.edu"}],"primaryOutcomes":["Change in State Anxiety Score as Measured by the Six-Item Short Form of the Spielberger State-Trait Anxiety Inventory (STAI-6)"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Music via Headphones for Anxiety","inPlainEnglish":"Many patients feel anxious before joint replacement surgery. This anxiety is common - affecting roughly 1 in 3 patients - and research has shown that patients who are more anxious before surgery tend to have more pain afterward and may need more pain medication during recovery.","whoItsFor":["Ages 18 Years to any","Adults 18 years or older undergoing primary THA, TKA, or UKA for osteoarthritis","Planned spinal/regional anesthesia","Willingness to undergo randomization"],"whoShouldSkip":["Chronic opioid use prior to surgery","Primary diagnosis other than osteoarthritis (e.g., fracture, posttraumatic arthritis, AVN)","Hearing impairment precluding music listening","Active psychiatric disorder requiring current pharmacotherapy"],"whatHappens":"If you join, the listed intervention(s) are Music via Headphones. The registry lists allocation as randomized. Many patients feel anxious before joint replacement surgery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 52 people at New York. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.518Z"},{"nctId":"NCT07848191","title":"Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis","officialTitle":"A Phase 4, Open-label, Multi-group Study of Rezdiffra® in Combination With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and Moderate to Advanced (F2-F3) Fibrosis, Administered According to Their Approved Labeling","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Madrigal Pharmaceuticals, Inc.","sponsorClass":"INDUSTRY","summary":"To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \\& Actos/pioglitazone)","conditions":["MASH - Metabolic Dysfunction-Associated Steatohepatitis"],"keywords":[],"interventions":[{"type":"DRUG","name":"Rezdiffra"},{"type":"DRUG","name":"Resmetirom"},{"type":"DRUG","name":"ACTOS/pioglitazone"},{"type":"DRUG","name":"FARXIGA/dapagliflozin"}],"enrollment":150,"startDate":"2026-10-07","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nAll Subjects:\n\n1. Willing to participate in the study and provide written informed consent.\n2. Meets all requirements per REZDIFFRA Prescribing Information, in the opinion of the PI.\n3. Male and female adults ≥18 of age at time of screening.\n4. Evidence of hepatic steatosis consistent with MASH demonstrated by an MRI-PDFF fat fraction \\>5% obtained during second screening period.\n5. Evidence of moderate-to-advanced fibrosis (F2-F3) without cirrhosis.\n6. Stable medical conditions and background medications (non-concomitant medications as defined in this protocol) per PI judgement.\n7. Female subjects of reproductive potential are eligible if they have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use 1 highly effective birth control method during the study and for at least 30 days after newly introduced medication administration.\n\n   Highly effective birth control methods include hormonal and non-hormonal intrauterine device, combination estrogen-progesterone hormonal contraception (oral, transdermal, or vaginal), tubal ligation, a vasectomized or sterile male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from Screening throughout the study, and for at least 30 days after newly introduced medication administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the subject's habitual practice. NOTE: Female subjects who are not of child-bearing potential (ie, surgically \\[bilateral oophorectomy, hysterectomy\\] or naturally sterile \\[\\>12 consecutive months without menses\\]) do not require contraception during the study.\n8. Must be taking a stable dose of ACTOS/pioglitazone for at least 2 months prior to Baseline. (Group A1)\n9. Must be taking a stable dose of FARXIGA/dapagliflozin for at least 2 months prior to Baseline. (Group A2)\n10. Must be taking a stable dose of REZDIFFRA for at least 2 months prior to Baseline. (Groups B1 and B2)\n11. Must not have previously taken RESMETIROM or ACTOS/pioglitazone or FARXIGA/dapagliflozin. (Group C)\n12. For Groups A1, B1, and C1: Meets all requirements per ACTOS/pioglitazone Prescribing Information, in the opinion of the PI.\n13. For Groups B1 and C1: (ie, naïve to ACTOS/pioglitazone): HbA1c at screening ≥7.0% and ≤10.0%.\n14. For Groups A2, B2, and C2: Meets all requirements per FARXIGA/dapagliflozin Prescribing Information, in the opinion of the PI.\n15. For Groups B2 and C2 (ie, naïve to FARXIGA/dapagliflozin): HbA1c at screening ≥7.0% and ≤10.0%.\n\nExclusion Criteria All subjects\n\n1. Off label use of the commercially available study medications.\n2. Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis.\n3. Other chronic liver diseases (eg, viral hepatitis, autoimmune hepatitis, hemochromatosis).\n4. Documented history of decompensated liver disease.\n5. Use of rosuvastatin or simvastatin at a dose greater than 20 mg/day, or pravastatin or atorvastatin at a dose greater than 40 mg/day, at the time of the first dose of resmetirom. Subjects receiving a statin dose above the applicable limit during the screening period may remain eligible if the dose is reduced to the applicable maximum permitted dose before the first dose of resmetirom.\n6. Any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the subject, or interfere with the study outcomes.\n7. Active or suspected bladder cancer.\n8. Diagnosis of heart failure.\n9. eGFR \\< 60mL/min/1.73 m2\n10. Developmental/intellectual disability, limited capacity of recognition, any history of clinically important emotional and/or psychiatric illness, inability to follow the study procedures, or any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.\n11. Individuals who are currently incarcerated or who are anticipated to be incarcerated during the study period.\n\n    Groups B and C:\n12. Unable to secure a prescription for a concomitant medication.","locations":[{"facility":"Arizona Liver Health - Chandler","city":"Chandler","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Arkansas Gastroenterology","city":"North Little Rock","state":"Arkansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Southern California Research Center","city":"Coronado","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inland Empire Liver Foundation","city":"Rialto","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Florida Research Institute","city":"Lakewood Rch","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gastro Health PLLC Galloway","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Med Research of Florida, LLC","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Elevate Clinical Research","city":"Lake Charles","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research - Morehead City - Multispecialty - PPDS","city":"Morehead City","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gastro Health Research","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Diabetes and Endocrine Consultants","city":"Chattanooga","state":"Tennessee","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Texas Clinical Research Institute","city":"Arlington","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"South Texas Endocrinology & Metabolism Center","city":"Corpus Christi","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Liver Institute at Methodist Dallas Medical Center","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Elevate Clinical Research - McAllen - PPDS","city":"McAllen","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diabetes and Glandular Disease Clinic, PA","city":"San Antonio","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tom Hare","phone":"267-406-0611","email":"info@madrigalpharma.com"}],"primaryOutcomes":["Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)","Number and Percentage of Participants With TEAEs by Maximum Severity","Number and Percentage of Participants With TEAEs by Relationship to Study Medication"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["dapagliflozin"],"locationSlugs":["chandler-arizona","north-little-rock-arkansas","coronado-california","rialto-california","lakewood-rch-florida","miami-florida","lake-charles-louisiana","morehead-city-north-carolina","cincinnati-ohio","chattanooga-tennessee","arlington-texas","corpus-christi-texas","dallas-texas","mcallen-texas","san-antonio-texas"],"enrichment":{"headline":"Phase 4: testing Rezdiffra for MASH - Metabolic Dysfunction-Associated Steatohepatitis","inPlainEnglish":"To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \\& Actos/pioglitazone)","whoItsFor":["Ages 18 Years to any","Meets all requirements per REZDIFFRA Prescribing Information, in the opinion of the PI","Male and female adults ≥18 of age at time of screening","Evidence of hepatic steatosis consistent with MASH demonstrated by an MRI-PDFF fat fraction \\>5% obtained during second screening period","Evidence of moderate-to-advanced fibrosis (F2-F3) without cirrhosis","Stable medical conditions and background medications (non-concomitant medications as defined in this protocol) per PI judgement","Must be taking a stable dose of ACTOS/pioglitazone for at least 2 months prior to Baseline. (Group A1)","Must be taking a stable dose of FARXIGA/dapagliflozin for at least 2 months prior to Baseline. (Group A2)"],"whoShouldSkip":["Off label use of the commercially available study medications","Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis","Other chronic liver diseases (eg, viral hepatitis, autoimmune hepatitis, hemochromatosis)","Documented history of decompensated liver disease","Any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the subject, or interfere with the study outcomes","Active or suspected bladder cancer","Diagnosis of heart failure"],"whatHappens":"If you join, the listed intervention(s) are Rezdiffra, Resmetirom, or ACTOS/pioglitazone. The registry lists allocation as randomized. To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \\& Actos/pioglitazone)","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 150 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.960Z"},{"nctId":"NCT07848477","title":"PROMOTE: Effects of 5-HT4 Agonism on Cognition and Sleep in Peopl With Low Mood","officialTitle":"Investigating the Effect of 5-HT4 Receptor Agonism on Cognition and Sleep in People With Low Mood","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"University of Oxford","sponsorClass":"OTHER","summary":"Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions. It works by attaching to different types of serotonin receptors on brain cells. These receptors act like \"locks\", with serotonin acting like a \"key\". Different types of serotonin receptors have different effects in the brain.\n\nPrucalopride is a licensed medication used to treat constipation. It acts on a particular serotonin receptor, called the serotonin 4 receptor. Researchers are interested in this receptor because understanding how it works in the brain may help us learn more about depression and could contribute to the development of new treatments in the future.\n\nThe purpose of this study is to investigate the effects of prucalopride in people experiencing low mood. We will compare prucalopride with a placebo (a treatment with no active medication) to find out whether activating the serotonin 4 receptor affects sleep and aspects of thinking, including memory, attention and decision making.","conditions":["Low Mood","Depression - Major Depressive Disorder"],"keywords":["Low Mood","Cognition","Sleep","Depression","prucalopride","5-HT4 receptor","cognitive function"],"interventions":[{"type":"DRUG","name":"Prucalopride"},{"type":"DRUG","name":"Placebo Comparator"}],"enrollment":60,"startDate":"2026-11-10","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged between 18-65\n* Male or female\n* Participant is willing and able to give informed consent for participation in the research\n* Body mass index in the range of 18-35 inclusive\n* Current PHQ-9 score in the range of 9-15\n\nExclusion Criteria:\n\n* Any current or previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD or PTSD.\n* A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia\n* Body Mass Index outside the range of 18 to 35 inclusive\n* Any significant current medical condition likely to interfere with conduct of the study or analysis of data\n* Current use of psychoactive and / or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion)\n* Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks)\n* High consumption of illicit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine)\n* Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study\n* Currently pregnant, trying to get pregnant, or breast feeding\n* Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome\n* Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose\n* Participation in a study that involves the use of a medication or novel vaccine within the last three months\n* Participation in a study using the same tasks in the last year\n* Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging, including yellow/blue colourblindness\n* A head injury causing concussion or loss of consciousness within the last six months\n* Moderate to high risk of suicide or self-harm\n* Participant who is unlikely to comply with the clinical study protocol or is unsuitable for any other reason, in the opinion of the Chief Investigator.\n\nAdditional Exclusion Criteria for Participants in the Sleep Study Cohort:\n\n* Unable to undergo cardiac monitoring\n* Unable to wear the sleep patch device for full monitoring period\n* Implanted neurostimulator or pacemaker","locations":[{"facility":"Warneford Hospital","city":"Oxford","state":"Oxfordshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Susannah Murphy, PhD","phone":"+441865618313","email":"susannah.murphy@psych.ox.ac.uk"},{"name":"Finley T Watton, MBiomedSci Neurosciences","phone":"+447593941882","email":"finley.watton@psych.ox.ac.uk"}],"primaryOutcomes":["Auditory Verbal Learning Test (AVLT)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Prucalopride for Low Mood","inPlainEnglish":"Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions. It works by attaching to different types of serotonin receptors on brain cells.","whoItsFor":["Ages 18 Years to 65 Years","Body mass index in the range of 18-35 inclusive","Current PHQ-9 score in the range of 9-15"],"whoShouldSkip":["Any current or previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD or PTSD","A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia","Body Mass Index outside the range of 18 to 35 inclusive","Any significant current medical condition likely to interfere with conduct of the study or analysis of data","Current use of psychoactive and / or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion)","Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks)","High consumption of illicit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine)"],"whatHappens":"If you join, the listed intervention(s) are Prucalopride, or Placebo Comparator. The registry lists allocation as randomized. Serotonin is a chemical in the brain that plays an important role in mood, sleep, and other functions.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Oxford. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.106Z"},{"nctId":"NCT07850310","title":"A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)","officialTitle":"A First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses, Food Effect, and Relative Bioavailability of MK-8644 in Healthy Japanese and Non-Japanese Participants and Multiple Doses of MK-8644 in Patients With Mild to Moderate Plaque Psoriasis","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people.\n\nThis trial will help researchers learn about the safety of MK-8644 and if participants tolerate it. Tolerate means participants will receive MK-8644 in the trial unless they need to stop it due to health problems.","conditions":["Psoriasis","Healthy"],"keywords":[],"interventions":[{"type":"DRUG","name":"MK-8644"},{"type":"DRUG","name":"Placebo for MK-8644"}],"enrollment":132,"startDate":"2026-10-20","completionDate":"2027-12-13","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Is in good health\n* Has a BMI between 18 and 36 kg/m\\^2, inclusive\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.\n* Has a history of cancer.\n* Has a history of significant multiple and/or severe allergies.\n* Has positive test(s) for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, tuberculosis, or HIV.","locations":[{"facility":"Nucleus Network ( Site 0001)","city":"Melbourne","state":"Victoria","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@merck.com"}],"primaryOutcomes":["Number of Participants Who Experience an Adverse Event (AE)","Number of Participants Who Discontinue Study Due to an AE"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["melbourne-australia"],"enrichment":{"headline":"Phase 1: testing MK-8644 for Psoriasis","inPlainEnglish":"The purpose of this trial is to learn about a trial medicine called MK-8644. This trial is the first time researchers will give MK-8644 to people.","whoItsFor":["Ages 18 Years to 65 Years","The main who can join include but are not limited to the following:","Has a body-mass index (BMI) between 18 and 36 kg/m\\^2, inclusive"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are MK-8644, or Placebo for MK-8644. The registry lists allocation as randomized. The purpose of this trial is to learn about a trial medicine called MK-8644.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 132 people at Melbourne. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.583Z"},{"nctId":"NCT07851025","title":"Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer","officialTitle":"A Randomised, Open-label, Phase III Study of Torvutatug Samrotecan in Combination With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Treatment in Participants With Non-HRD Positive Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (TREVI-OC-02)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This study will evaluate the efficacy, safety and tolerability of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab monotherapy as first line maintenance treatment in patients with non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.","conditions":["Epithelial Ovarian Cancer"],"keywords":["Epithelial ovarian cancer","Fallopian tube cancer","Primary peritoneal cancer","Folate receptor alpha","Antibody-drug conjugate","TREVI-OC-02","Torvutatug samrotecan","Torvu-sam","Homologous recombination deficiency (HRD)","Non-HRD positive"],"interventions":[{"type":"DRUG","name":"Torvutatug samrotecan"},{"type":"DRUG","name":"Bevacizumab"}],"enrollment":950,"startDate":"2026-09-16","completionDate":"2030-06-28","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Participants with newly diagnosed FIGO Stage III/IV, histologically confirmed epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma\n* Provision of an archival FFPE tumour sample\n* Participants who have completed at least 6 cycles and a maximum of 8 cycles of first-line Platinum-based chemotherapy (PBC) prior to randomisation\n* Participants must have received a minimum of 3 cycles of bevacizumab in combination with the 3 last cycles of PBC, prior to randomisation\n* Participants who have completed cytoreductive surgery or have inoperable disease\n* Participants with non-progressive disease upon completion of front-line induction therapy\n\nKey Exclusion Criteria:\n\n* Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours\n* BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status\n* Participants with history of (non-infectious) ILD/pneumonitis that required steroids or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening\n* Participants with non-healing wound, active ulcer, or bone fracture\n* Participants with evidence of active or ongoing bowel obstruction\n* Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)","locations":[{"facility":"Research Site","city":"Tamarac","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Baton Rouge","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Baltimore","state":"Maryland","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Billings","state":"Montana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Cleveland","state":"Ohio","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Capital Federal","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Ciudad de Buenos Aires","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Córdoba","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Rosario","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Salta","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Santa Fe","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Viedma","state":"","country":"Argentina","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Auchenflower","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Benowa","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hobart","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kingswood","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nedlands","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Port Macquarie","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Randwick","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Richmond","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Toorak Gardens","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wollongong","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Woodville","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fortaleza","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Itajaí","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jaú","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Natal","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Porto 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have completed cytoreductive surgery or have inoperable disease","Participants with non-progressive disease upon completion of front-line induction therapy"],"whoShouldSkip":["Participants with tumours of non-epithelial origin, borderline tumours, or low-grade epithelial tumours","BRCA1/2 mutation (germline or somatic) or HRD positive, unknown, or inconclusive tumour status","Participants with history of (non-infectious) ILD/pneumonitis that required steroids or supplemental oxygen, or has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening","Participants with non-healing wound, active ulcer, or bone fracture","Participants with evidence of active or ongoing bowel obstruction","Prior exposure to any FRα-targeted therapy, including MIRV, or any TOP1i Antibody-drug Conjugate (ADC)"],"whatHappens":"If you join, the listed intervention(s) are Torvutatug samrotecan, or Bevacizumab. The registry lists allocation as randomized. This study will measure the how well it works, whether it is safe and how hard side effects are to live with of Torvutatug samrotecan (torvu-sam) in combination with bevacizumab compared with bevacizumab this drug alone as first line maintenance treatment in patients with non-Homologous Recombination Deficient (non-HRD) positive advanced ovarian cancer.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 950 people at 173 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.178Z"},{"nctId":"NCT07851103","title":"A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer","officialTitle":"A First-in-human, Multicentre, Phase Ia Dose Escalation Study of BI 3968621 as Monotherapy and in Combination With Ezabenlimab to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumour Activity in Patients With Advanced Solid Tumours","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Boehringer Ingelheim","sponsorClass":"INDUSTRY","summary":"This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time.\n\nThe study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks.\n\nParticipants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.","conditions":["Advanced Solid Tumour"],"keywords":[],"interventions":[{"type":"DRUG","name":"BI 3968621"},{"type":"DRUG","name":"ezabenlimab"}],"enrollment":90,"startDate":"2026-11-10","completionDate":"2030-09-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male and female participants ≥18 years of age and at least at the legal age of consent\n* Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease\n* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Life expectancy ≥3 months at the start of treatment in the opinion of the investigator\n* Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria\n* Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)\n* Patient with known leptomeningeal disease or spinal cord compression due to disease\n* Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)\n* Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria\n* Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)\n* Patient with a diagnosis of immunodeficiency other than HIV\n* Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.","locations":[{"facility":"Florida Cancer Specialists-Sarasota-61670","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Emory University","city":"Atlanta","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute-Nashville-48456","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universitair Ziekenhuis Gent","city":"Ghent","state":"","country":"Belgium","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut Gustave Roussy","city":"Villejuif","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Japanese Foundation for Cancer Research","city":"Tokyo, Koto-ku","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clinico De Valencia (INCLIVA)","city":"Valencia","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Boehringer Ingelheim","phone":"018002430127","email":"clintriage.rdg@boehringer-ingelheim.com"}],"primaryOutcomes":["Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)","Objective response (OR)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["sarasota-florida","atlanta-georgia","philadelphia-pennsylvania","nashville-tennessee","houston-texas","ghent-belgium","villejuif-france","tokyo-koto-ku-japan","barcelona-spain","valencia-spain"],"enrichment":{"headline":"Phase 1: testing BI 3968621 for Advanced Solid Tumour","inPlainEnglish":"This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. this study wants to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab.","whoItsFor":["Ages 18 Years to any","Male and female participants ≥18 years of age and at least at the legal age of consent","At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1","Life expectancy ≥3 months at the start of treatment in the opinion of the investigator","Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria","Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further who can join apply"],"whoShouldSkip":["Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)","Patient with known leptomeningeal disease or spinal cord compression due to disease","Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)","Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria","Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)","Patient with a diagnosis of immunodeficiency other than HIV","Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further"],"whatHappens":"If you join, the listed intervention(s) are BI 3968621, or ezabenlimab. The registry lists allocation as randomized. This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at 10 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.707Z"},{"nctId":"NCT07851259","title":"A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","officialTitle":"A Phase II, Randomized, Double-Masked, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of RO7965032 in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Genentech, Inc.","sponsorClass":"INDUSTRY","summary":"This study will assess the safety and efficacy of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)","conditions":["Geographic Atrophy Secondary to Age-Related Macular Degeneration"],"keywords":[],"interventions":[{"type":"DRUG","name":"RO7965032"},{"type":"DRUG","name":"Placebo"}],"enrollment":321,"startDate":"2027-01-08","completionDate":"2030-08-21","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nOcular Inclusion Criteria for the Study Eye\n\n* BCVA score of \\>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters\n* Lesions may be either extrafoveal or subfoveal\n\nOcular Inclusion Criteria for Both Eyes\n\n* Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging\n* Well-demarcated GA secondary to AMD\n\nExclusion Criteria:\n\nGeneral Exclusion Criteria - History of hypersensitivity, a severe allergic reaction or anaphylactic reaction to any component of the investigational drug injection\n\nOcular Exclusion Criteria for the Study Eye\n\n* History of diabetic macular edema (DME), retinal vein occlusion, corneal transplant, retinal detachment, Stage 3 or 4 macular hole, optic neuropathy, or retinal dystrophy\n* Current or prior history of central serous retinopathy\n* Aphakia or absence of the posterior capsule in the study eye\n\nOcular Exclusion Criteria for the Non-Study Eye\n\n\\- Non-functioning non-study eye defined as either BCVA of hand motion or worse or no physical presence of non-study eye (i.e., monocular)\n\nOcular Exclusion Criteria for Either Eye\n\n* Proliferative diabetic retinopathy\n* History of recurrent infectious or inflammatory ocular disease\n* Current or prior history of choroidal neovascularization (CNV) in either eye\n* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye\n\nOther protocol-defined inclusion/exclusion criteria may apply","locations":[{"facility":"Bay Area Retina Specialists Medical Group - Vestrum - PPDS","city":"Walnut Creek","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Retina Specialists","city":"Winston-Salem","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Erie Retina Research","city":"Erie","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Retina Associates - Arlington","city":"Arlington","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Piedmont Eye Center","city":"Lynchburg","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Reference Study ID Number: XR46785 https://forpatients.roche.com/No attachments to email below.","phone":"888-662-6728 (U.S. and Canada)","email":"global-roche-genentech-trials@gene.com"},{"name":"Fastest Response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry","phone":"","email":""}],"primaryOutcomes":["Change of GA Lesion Area in the Study Eye","Incidence and Severity of Ocular Adverse Events (AEs)","Incidence and Severity of Non-Ocular AEs"],"hasResults":false,"conditionSlugs":["macular-degeneration"],"drugSlugs":[],"locationSlugs":["walnut-creek-california","winston-salem-north-carolina","erie-pennsylvania","arlington-texas","lynchburg-virginia"],"enrichment":{"headline":"Phase 2: testing RO7965032 for Geographic Atrophy Secondary to Age-Related Macular Degeneration","inPlainEnglish":"This study will assess the safety and how well it works of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)","whoItsFor":["Ages 50 Years to any","Ocular who can join for the Study Eye","BCVA score of \\>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters","Lesions may be either extrafoveal or subfoveal","Ocular who can join for Both Eyes","Sufficiently clear ocular media, adequate pupillary dilation, and fixation to permit quality fundus imaging","Well-demarcated GA secondary to AMD"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are RO7965032, or Placebo. The registry lists allocation as randomized. This study will assess the safety and how well it works of RO7965032 to address a significant unmet medical need in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD)","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 321 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.149Z"},{"nctId":"NCT07853807","title":"Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium (CNTRACS): Study 1","officialTitle":"Cognitive Neurocomputational Task Reliability & Clinical Applications Consortium","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance. This will include determining whether hallucinations and delusions are best explained by separate underlying processes or by a single process. Investigators will also test whether the model-based parameters from these studies are more precise and sensitive than standard behavioral methods for assessing deficits across psychotic disorders and for predicting hallucinations and delusions (Aim 1). Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls (HC) \\[HC, N=125\\]; B) schizophrenia and schizoaffective disorder \\[SZ/SZA, N=200\\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \\~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups. Investigators will also validate key model-based parameters against well-characterized neurophysiological measures using electroencephalogram (EEG) (Aim 4). The data from Study 1 will also be used to optimize (e.g., length, floor, and ceiling effects) tasks for Study 2. To generate a sample with sufficient variation in hallucinations and delusions, investigators will recruit the following groups that balance feasibility with clinical relevance: A) healthy controls (HC) \\[HC, N=125\\]; B) schizophrenia and schizoaffective disorder \\[SZ/SZA, N=200\\]). For Study 1, investigators will ensure that 40 patients are unmedicated. Investigators anticipate a \\~20% screen fail/drop-out rate based on our prior Cognitive Neuroscience Test Reliability and Clinical Applications for Schizophrenia Consortium (CNTRACS) studies. Thus, investigators will run an additional 40 SZ/SZA and 15 HC. All sites have experience recruiting patients in each of these groups as indicated by our past successful studies, and the fact that investigators have been able to recruit patients with significant hallucinations and delusions in all groups.","conditions":["SCHIZOPHRENIA 1 (Disorder)","Schizoaffective Disorder","Healthy Adult Participants"],"keywords":["schizophrenia","schizoaffective disorder","healthy controls"],"interventions":[{"type":"BEHAVIORAL","name":"Motion Perception Task"},{"type":"BEHAVIORAL","name":"Sine Wave Speech Task"},{"type":"BEHAVIORAL","name":"Volatility Task"},{"type":"BEHAVIORAL","name":"Choice Probabilistic Reversal Task"},{"type":"BEHAVIORAL","name":"Kamin Blocking Task"},{"type":"BEHAVIORAL","name":"Minnesota Trust Game"},{"type":"BEHAVIORAL","name":"Dynamic Trust Game"}],"enrollment":325,"startDate":"2026-11-15","completionDate":"2031-06-30","sex":"ALL","minAge":"18 Years","maxAge":"59 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nGeneral Inclusion\n\n1. age 18 to 59\n2. no substance disorder in past six months (confirmed with urine drug screens and breathalyzers);\n3. no clinically significant head injury or neurological disease. 4. Wechsler Test of Adult Reading (WTAR) score =16+.\n\nGroup Specific Criteria: Schizophrenia/Schizoaffective Disorder (SZ):\n\n1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective;\n2. no medication changes in prior month or anticipated in the next month or not taking medications\n3. outpatient or partial hospital if unmedicated\n\nHealthy Controls (HC):\n\n1. no Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder;\n2. no family history of psychosis or bipolar\n\nExclusion Criteria:\n\nHealthy Controls (HC):\n\n1. Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder diagnosis\n2. Family history of psychosis or bipolar\n\nSchizophrenia/Schizoaffective Disorder (SZ/SZA): additional exclusion criteria for the unmedicated individuals are:\n\n1. not in acute exacerbation requiring immediate hospitalization or treatment\n2. self-reported medication non-compliance for at least the four previous weeks 3)never having started medications","locations":[{"facility":"University of California, Irvine","city":"Irvine","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Maryland, Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deanna Barch, Ph.D.","phone":"314-935-8729","email":"dbarch@wustl.edu"},{"name":"Clinical Coordinator","phone":"314-747-2160","email":"ingram@wustl.edu"}],"primaryOutcomes":["Motion Perception Task Performance","Sine Wave Speech Task Performance","Volatility Task Performance","Choice Probabilistic Reversal Performance Task","Kamin Blocking Task Performance","Minnesota Trust Game Performance","Dynamic Trust Game Performance"],"hasResults":false,"conditionSlugs":["als","schizophrenia"],"drugSlugs":[],"locationSlugs":["irvine-california","chicago-illinois","baltimore-maryland","minneapolis-minnesota","st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: Motion Perception Task for SCHIZOPHRENIA 1 (Disorder)","inPlainEnglish":"In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function). Investigators will also directly compare the tasks in terms of predictive ability and psychometric properties and determine whether the tasks share variance or explain unique variance.","whoItsFor":["Ages 18 Years to 59 Years","no substance disorder in past six months (confirmed with urine drug screens and breathalyzers);","no clinically significant head injury or neurological disease. 4. Wechsler Test of Adult Reading (WTAR) score =16+","Group Specific Criteria: Schizophrenia/Schizoaffective Disorder (SZ):","Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnosis of schizophrenia or schizoaffective;","no medication changes in prior month or anticipated in the next month or not taking medications","outpatient or partial hospital if unmedicated","Healthy Controls (HC):"],"whoShouldSkip":["Healthy Controls (HC):","Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) Psychosis or Bipolar Disorder diagnosis","Family history of psychosis or bipolar","Schizophrenia/Schizoaffective Disorder (SZ/SZA): additional"],"whatHappens":"If you join, the listed intervention(s) are Motion Perception Task, Sine Wave Speech Task, or Volatility Task. The registry lists allocation as na. In Study 1, investigators will test the ability of each of the seven paradigms to differentiate between schizophrenia (SZ)/schizoaffective disorder (SZA) and matched healthy control subjects (HC) and to predict individual differences in clinical measures of hallucinations and delusions (as well as measures of function).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 325 people at 5 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.036Z"},{"nctId":"NCT07854782","title":"Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","officialTitle":"A Phase 3, Randomized, Double-blind, Placebo-controlled Trial of ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Regeneron Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD. MASLD is a liver condition caused by too much fat building up in the liver. This can lead to liver scarring and inflammation and can reduce the liver's ability to keep the body healthy. Cell death-inducing DFFA-like effector B (CIDEB) is a protein made by liver cells that helps the liver to store fat.\n\nThe study is looking at:\n\n* What side effects ALN-CIDEB might cause\n* How well ALN-CIDEB works to change liver fat, liver injury, and liver scarring\n* How ALN-CIDEB could affect the body and the liver, which can help researchers understand why ALN-CIDEB works better for some people than others","conditions":["Metabolic Dysfunction-Associated Steatotic Liver Disease","MASLD"],"keywords":["NAFLD","NASH","Metabolic Dysfunction-Associated Steatohepatitis","MASH","Fatty Liver Disease","Non-alcoholic Fatty Liver Disease","Liver Fibrosis","Steatotic Liver Disease","SLD","Metabolic Fatty Liver Disease","Hepatic Steatosis","Fatty Liver","Liver Fat","Excess Liver Fat","Obesity","Insulin Resistance"],"interventions":[{"type":"DRUG","name":"ALN-CIDEB"},{"type":"DRUG","name":"Placebo"}],"enrollment":1500,"startDate":"2026-10-28","completionDate":"2029-03-03","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n1. Has a clinical diagnosis of MASLD, as defined in the protocol\n2. Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol\n2. Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening\n3. Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score \\>12\n4. Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion\n5. Has prior, current, or planned future use (during the treatment period) of a GLP-1 receptor agonist-based therapy or any medication approved for the treatment of MASH (eg, resmetirom) unless used at a generally stable dose and regimen since at least 3 months prior to screening visit and throughout the screening period with no change to the dose or regimen anticipated during the treatment period, as defined in the protocol\n6. Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol\n\nNOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply","locations":[{"facility":"Med Research of Florida, LLC","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Marrero","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Metairie","state":"Louisiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Medical Trials","city":"Georgetown","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Administrator","phone":"844-734-6643","email":"clinicaltrials@regeneron.com"}],"primaryOutcomes":["Occurrence of Treatment Emergent Adverse Events (TEAEs)","Severity of TEAEs"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["miami-florida","marrero-louisiana","metairie-louisiana","georgetown-texas"],"enrichment":{"headline":"Phase 3: testing ALN-CIDEB for Metabolic Dysfunction-Associated Steatotic Liver Disease","inPlainEnglish":"This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH). MASH is more advanced stage of a broader liver disease, MASLD.","whoItsFor":["Ages 18 Years to 75 Years","Has a clinical diagnosis of MASLD, as defined in the protocol","Has a liver stiffness measurement between 6 and 20 kilopascals (kPa), as measured by a FibroScan® scan during screening or within approximately 3 months of screening, as defined in the protocol"],"whoShouldSkip":["Has a known chronic liver disease other than MASLD, as determined by the investigator, as defined in the protocol","Has prior or current suspected or known drug-induced liver injury within approximately 1 year prior to screening","Has a history of liver transplantation, current placement on a liver transplant list, or Model for End-Stage Liver Disease (MELD) score \\>12","Has a known history of alcohol or other substance abuse within the last year or at any time during screening based on investigator's discretion","Has evidence of uncontrolled human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection during screening, as defined in the protocol","NOTE: Other Protocol-defined Inclusion/"],"whatHappens":"If you join, the listed intervention(s) are ALN-CIDEB, or Placebo. The registry lists allocation as randomized. This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,500 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.148Z"},{"nctId":"NCT07855133","title":"A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Semaglutide Medication","officialTitle":"An Open-label, Multiple-arm Study to Assess Tolerability in Participants With Overweight or Obesity, With or Without Type 2 Diabetes, When Switching From Semaglutide to Zenagamtide","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of semaglutide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get semaglutide and zenagamtide.","conditions":["Overweight","Obesity","Type 2 Diabetes"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide"},{"type":"DRUG","name":"Zenagamtide"}],"enrollment":60,"startDate":"2026-10-05","completionDate":"2028-09-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18 years or older at the time of signing the informed consent.\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n* Participants on a stable treatment dose of (subcutaneous) s.c. semaglutide for at least 4 weeks.\n\nOnly for participants with T2D:\n\n* Diagnosed with type 2 diabetes before screening.\n* Treatment with 0-2 marketed oral glucose-lowering medications (metformin or sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily doses) for at least 90 days before screening.\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* History of reduction in dose of semaglutide, due to intolerability, without successful reescalation.\n* Presence of any clinically relevant condition that causes symptoms which are similar to the gastrointestinal adverse events (GI AEs) linked to glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment, and which could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints.\n* Ongoing use of medications causing clinically relevant gastrointestinal symptoms that could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints, as judged by the investigator.\n* Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are:\n* use of s.c. semaglutide as described in inclusion criterion 5\n* glucose-lowering medication mentioned in inclusion criterion 7 (only for participants with T2D)\n* stable use (initiated minimum 30 days before screening) of statins, blood pressure lowering medicine, beta blockers\n* highly effective contraceptives\n* occasional use of paracetamol, ibuprofen and acetylsalicylic acid.\n\nOnly for participants without T2D:\n\n\\- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.\n\nOnly for participants with T2D:\n\n* Glycated haemoglobin (HbA1c) more than or equal to (≥) 10.5 percent (%) \\[91 millimoles per mole (mmol/mol)\\] at screening.\n* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions, except conditions associated with diabetes mellitus.","locations":[{"facility":"PAREXEL Glendale/LA EPCU","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PAREXEL Intl - EPCU-Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["Number of treatment emergent adverse events (TEAE)"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["glendale-california","baltimore-maryland"],"enrichment":{"headline":"Phase 1: testing Semaglutide for Overweight","inPlainEnglish":"The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of semaglutide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get semaglutide and zenagamtide.","whoItsFor":["Ages 18 Years to any","Male or female (sex assigned at birth, inclusive of all gender identities)","Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator","Participants on a stable treatment dose of (subcutaneous) s.c. semaglutide for at least 4 weeks","Only for participants with T2D:","Diagnosed with type 2 diabetes before screening"],"whoShouldSkip":["Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method","History of reduction in dose of semaglutide, due to intolerability, without successful reescalation","Ongoing use of medications causing clinically relevant gastrointestinal symptoms that could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints, as judged by the investigator","Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are:","use of s.c. semaglutide as described in inclusion criterion 5","glucose-lowering medication mentioned in inclusion criterion 7 (only for participants with T2D)","stable use (initiated minimum 30 days before screening) of statins, blood pressure lowering medicine, beta blockers"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide, or Zenagamtide. The registry lists allocation as na. The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of semaglutide in people with overweight or obesity, with or without type 2 diabetes (T2D).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.734Z"},{"nctId":"NCT07855211","title":"A Study to Learn About the Safety of BIIB147 and Its Effects in Adults With Amyotrophic Lateral Sclerosis (ALS)","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled MAD Study With Open-Label Extension to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BIIB147 Administered Intrathecally to Adult Participants With ALS","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"QUADRUPLE","sponsor":"Biogen","sponsorClass":"INDUSTRY","summary":"In this study, researchers will learn more about the effects of BIIB147, in participants with amyotrophic lateral sclerosis, also known as ALS. ALS is a rare disease that damages the motor neurons in the brain and spinal cord that help control the movement of muscles in the body. It is a progressive disease, which means that it gets worse with time. Over time, this causes increasing problems with speaking, swallowing, moving the arms and legs, and breathing. In the case of ALS, this eventually leads to death from patients not being able to breathe.\n\nThis is a \"first-in-human\" study. This means that this study drug will be given to people for the very first time in this study. These studies are important because they help researchers learn about the safety of the study drug, how the body processes it, and what dose might be appropriate before testing it in larger groups.\n\nThe main goal of the study is to learn about the safety of BIIB147 in adult participants with ALS. The main question researchers want to answer is:\n\n* How many participants have adverse events and serious adverse events during the study? Adverse events are health problems that may or may not be caused by the study drug.\n* Researchers will also learn more about:\n\n  * How much BIIB147 gets into the blood?\n  * What is the highest amount of BIIB147 found in the blood?\n  * How long does it take BIIB147 to reach its highest amount in the blood?\n  * How much neurofilament light chain (NfL) protein is found in the blood?\n  * How longer-term treatment with BIIB147 affects disease worsening and the participants' overall survival?\n\nThis study will be done as follows:\n\n* Participants will join the study after signing an informed consent form, also known as an ICF.\n* Participants will be screened to check if they can join the study. The screening period will be up to 4 weeks.\n* Participants will be randomly assigned to get either the study drug BIIB147 or a placebo during the main treatment period. A placebo is something that looks like the study drug but does not contain any medicine. A placebo is also given the same as the study drug.\n* Neither the participants nor the researchers will know if participants are getting the study drug or the placebo.\n* BIIB147 or the placebo will be given through a lumbar puncture. This is done using a thin needle that is put into the lower part of the spine.\n* During the main treatment period, participants will have regular clinic visits and phone calls. At the visits, the study doctor will do tests to check the participants' overall health, including their brain and nerve function. The participants' breathing function, tongue strength, and muscle strength will also be checked. They will also measure the participants' height, weight, and vital signs and collect blood and urine samples. Participants will also complete questionnaires or answer questions about how they are feeling and about their daily lives.\n* After finishing treatment in the main part of the study, some participants who qualify may be able to join a \"long-term extension\" part of the study. This may last up to 6 years or more. During this part of the study, all participants will get BIIB147.\n* After the long-term extension is done, participants will join a follow-up safety period. If participants do not enter the long-term extension, they will go directly into the follow-up safety period once the treatment period is done.\n* Each participant will be in the study for up to 8 years or more.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":[],"interventions":[{"type":"DRUG","name":"BIIB147"},{"type":"DRUG","name":"Placebo"}],"enrollment":69,"startDate":"2026-10-07","completionDate":"2034-01-23","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\nMAD Period\n\n* Participants must have a diagnosis of ALS consistent with the Gold Coast criteria.\n* No pathogenic variants, likely pathogenic variants, or variants of uncertain significance in the superoxide dismutase 1 (SOD1) or fused in sarcoma (FUS) genes (confirmed by central genetic testing).\n* Greater than or equal to (≥) 50% of predicted value for slow vital capacity (SVC) as adjusted for sex, age, and height (from the sitting position).\n* If taking riluzole, participant must be on a stable dose for ≥ 30 days prior to Day 1 and expected to remain at that dose until the final study visit end of study (EOS)/early termination (ET), unless the Investigator determines that it should be discontinued for medical reasons, in which case it may not be restarted during the study.\n\nOLE\n\n* Participants must have completed Study 303AS101 MAD period; all pre-dose assessments for the end of MAD treatment period visit (Day 113 for Cohorts A, B, C, and Day 169 for Cohort D) must be completed prior to dosing in OLE.\n\nKey Exclusion Criteria:\n\nMAD Period\n\n* History or positive test result at screening for human immunodeficiency virus (HIV). The requirement for testing at screening may be omitted if it is not permitted by local regulations.\n* History of confounding neuromuscular or neurological disorder that is expected to have a progressive (i.e., worsening) course during the study, and/or is expected to be associated with elevations in NfL, in the opinion of the Investigator.\n* Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period.\n* Requires permanent ventilation (using \\> 22 hours per day \\[h/day\\] invasive or non-invasive ventilation)\n* History of a deep venous thrombosis or pulmonary embolism ≤2 years of screening, or since the date of ALS diagnosis, whichever is longer.\n* Treatment with an approved ALS disease-modifying therapy other than riluzole or edaravone, or another investigational drug (including investigational drugs for ALS through compassionate use programs), biological agent, or device within 1 month or 5 half-lives of study agent, whichever is longer, before completion of Screening.\n* Current enrollment or a plan to enroll in any interventional clinical study. Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator and after consultation with the Sponsor.\n\nOLE\n\n* Any new condition or worsening of an existing condition that, according to the Investigator, would make the participant unsuitable for inclusion, could interfere with the assessment of safety, or would compromise the ability of the participant to undergo study procedures.\n* Clinically significant abnormalities (based on most recent assessments in MAD period) in hematology, blood chemistry parameters, or 12-lead electrocardiogram (ECG) prior to first OLE visit that would make the participant unsuitable for inclusion as assessed by the Investigator.\n\nNote: Other protocol-defined Inclusion/Exclusion criteria do apply.","locations":[{"facility":"Washington University School of Medicine_St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Austin Neuromuscular Center_Austin","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"US Biogen Clinical Trial Center","phone":"866-633-4636","email":"clinicaltrials@biogen.com"},{"name":"Global Biogen Clinical Trial Center","phone":"","email":"clinicaltrials@biogen.com"}],"primaryOutcomes":["MAD, OLE, Integrated MAD and OLE Periods: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["st-louis-missouri","austin-texas"],"enrichment":{"headline":"Phase 1 / Phase 2: testing BIIB147 for Amyotrophic Lateral Sclerosis","inPlainEnglish":"In this study, researchers will learn more about the effects of BIIB147, in participants with amyotrophic lateral sclerosis, also known as ALS. ALS is a rare disease that damages the motor neurons in the brain and spinal cord that help control the movement of muscles in the body.","whoItsFor":["Ages 18 Years to any","Participants must have a diagnosis of ALS consistent with the Gold Coast criteria","No pathogenic variants, likely pathogenic variants, or variants of uncertain significance in the superoxide dismutase 1 (SOD1) or fused in sarcoma (FUS) genes (confirmed by central genetic testing)","Greater than or equal to (≥) 50% of predicted value for slow vital capacity (SVC) as adjusted for sex, age, and height (from the sitting position)","Participants must have completed Study 303AS101 MAD period; all pre-dose assessments for the end of MAD treatment period visit (Day 113 for Cohorts A, B, C, and Day 169 for Cohort D) must be completed prior to dosing in OLE"],"whoShouldSkip":["History or positive test result at screening for human immunodeficiency virus (HIV). The requirement for testing at screening may be omitted if it is not permitted by local regulations","History of confounding neuromuscular or neurological disorder that is expected to have a progressive (i.e., worsening) course during the study, and/or is expected to be associated with elevations in NfL, in the opinion of the Investigator","Current or anticipated need, in the opinion of the Investigator, of a diaphragm pacing system during the study period","Requires permanent ventilation (using \\> 22 hours per day \\[h/day\\] invasive or non-invasive ventilation)","History of a deep venous thrombosis or pulmonary embolism ≤2 years of screening, or since the date of ALS diagnosis, whichever is longer","Current enrollment or a plan to enroll in any treatment clinical study. Participation in a noninterventional study focused on ALS natural history may be allowed at the discretion of the Investigator and after consultation with the Sponsor","Any new condition or worsening of an existing condition that, according to the Investigator, would make the participant unsuitable for inclusion, could interfere with the assessment of safety, or would compromise the ability of the participant to undergo study procedures"],"whatHappens":"If you join, the listed intervention(s) are BIIB147, or Placebo. The registry lists allocation as randomized. In this study, researchers will learn more about the effects of BIIB147, in participants with amyotrophic lateral sclerosis, also known as ALS.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 69 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.606Z"},{"nctId":"NCT07855692","title":"The Clinical Trial of Tamibarotene for Patients With HFpEF (RELIEF Trial)","officialTitle":"A Multicenter, Randomized, Placebo-controlled, Double-blind Clinical Trial: The Exploratory Clinical Trial to Evaluate the Efficacy and Safety of Low-dose Tamibarotene on Improving NT-proBNP in Patients With Heart Failure With Preserved Ejection Fraction (RELIEF Trial)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Nagoya University","sponsorClass":"OTHER","summary":"This study will evaluate the effect of 12 weeks of treatment with tamibarotene compared with placebo on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).","conditions":["HFpEF - Heart Failure With Preserved Ejection Fraction"],"keywords":["HFpEF"],"interventions":[{"type":"DRUG","name":"Tamibarotene"},{"type":"DRUG","name":"Placebo"}],"enrollment":90,"startDate":"2026-11-05","completionDate":"2029-05-31","sex":"ALL","minAge":"26 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Patients who have been diagnosed with heart failure at least 12 weeks prior to providing informed consent and are classified as NYHA Class II to IV at screening.\n* 2\\. Patients with LVEF of 50% or more as determined by echocardiography at screening.\n* 3\\. Patients with an NT-proBNP level of 300 pg/mL or more at screening (or 600 pg/mL or more for patients with atrial fibrillation at screening).\n* 4\\. Patients have evidence of structural heart disease (left atrial enlargement and/or left ventricular hypertrophy) based on echocardiography at screening, or who have a history of hospitalization for heart failure within 12 months prior to providing informed consent.\n* 5\\. Patients receiving any of the following medications whose dosage regimen has remained unchanged for at least 4 weeks prior to the initiation of investigational product administration:\n\n  ・Diuretics,SGLT2 inhibitors, ARNIs, ARBs, ACE inhibitors, MRAs, beta-blockers, digitalis preparations, HCN channel blockers, Soluble guanylate cyclase stimulators\n* 6\\. Patients with eGFR of 30 mL/min/1.73 m² or more at screening.\n* 7\\. Patients with a BMI of less than 45 kg/m² at screening.\n* 8\\. Patients with a systolic blood pressure of 160 mmHg or less and a diastolic blood pressure of 100 mmHg or less at screening, whose antihypertensive medication regimen has remained unchanged for at least 4 weeks prior to the initiation of investigational product administration.\n* 9\\. Patients who agree to comply with the applicable requirement(s) below:\n* 1\\) For female patients of childbearing potential, willingness to use contraceptionii from 30 days before the initiation of investigational product administration until 2 years after the end of investigational product administration.\n* 2\\) For male patients with partners of childbearing potential, willingness to use contraceptionii from the initiation of investigational product administration until 6 months after the end of investigational product administration, and to refrain from sperm donation during this period.\n* 10\\. Patients who are at least 26 years of age at the time informed consent is obtained.\n* 11\\. Patients who have voluntarily provided written informed consent after receiving adequate information about the study.\n\nExclusion Criteria:\n\n* 1\\. Patients diagnosed with acute heart failure, atrial fibrillation, or atrial flutter with a resting heart rate greater than 110 bpm within 4 weeks prior to enrollment.\n* 2\\. Patients with a history of myocardial infarction or unstable angina within 12 weeks prior to enrollment.\n* 3\\. Patients with chronic heart failure attributable to cardiac amyloidosis, glycogen storage disease, hypertrophic cardiomyopathy, active myocarditis, mitochondrial cardiomyopathy, cardiac sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, constrictive endocarditis, cardiac tamponade, untreated severe valvular heart disease, congenital heart disease, or other similar conditions.\n* 4\\. Patients who have undergone PCI, CABG, valvuloplasty, valve replacement surgery, catheter ablation, implantation of an ICD, CRT, or any other cardiac surgery within 12 weeks prior to enrollment, or who are expected to require any of these procedures during the study period.\n* 5\\. Patients who have received mechanical circulatory support within 12 weeks prior to enrollment.\n* 6\\. Patients with a history of stroke or transient ischemic attack within 12 weeks prior to enrollment.\n* 7\\. Patients with evidence of increased bleeding tendency or coagulation abnormalities, including thromboembolic disorders or hemorrhagic disorders (except for patients whose condition is adequately controlled with anticoagulants, antiplatelet agents, or similar medications).\n* 8\\. Patients with pulmonary diseases, including primary pulmonary hypertension, chronic thromboembolic pulmonary hypertension, COPD, or interstitial lung disease.\n* 9\\. Patients with hepatic impairment (AST 100 IU/L or more, or ALT 100 IU/L or more).\n* 10\\. Patients with LDL cholesterol 180 mg/dL or more, or TG (non-fasting)300 mg/dL or more at screening.\n* 11\\. Patients receiving maintenance dialysis or those considered likely to require initiation of dialysis within 1 year.\n* 12\\. Patients with type 1 diabetes mellitus.\n* 13\\. Patients with hemoglobin less than 9.0 g/dL at screening.\n* 14\\. Patients with malignant neoplasms.\n* 15\\. Patients whose life expectancy is anticipated to be less than 1 year.\n* 16\\. Patients currently receiving vitamin A preparations or regularly taking supplements containing vitamin A.\n* 17\\. Patients with hypervitaminosis A.\n* 18\\. Breastfeeding female patients (except those who agree to discontinue breastfeeding during the investigational product treatment period and for 6 months after the last dose of investigational product).\n* 19\\. Pregnant female patients or female patients with a positive pregnancy test result (female patients of childbearing potential who have had menstruation within 12 months prior to enrollment must undergo pregnancy testing; female patients for whom the possibility of pregnancy cannot be excluded, including those with amenorrhea for more than 12 months due to reasons such as chemical menopause, must also undergo pregnancy testing).\n* 20\\. Patients with a history of hypersensitivity or anaphylactic reaction to any component of the investigational product.\n* 21\\. Patients who have participated in, or are currently participating in, a clinical trial (observational clinical researches are permitted) within 4 weeks prior to enrollment.\n* 22\\. Patients whom the Principal Investigator or Sub-Investigator considers unsuitable for participation in this study.","locations":[{"facility":"Nagoya University","city":"Nagoya","state":"Aichi-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"National Center for Geriatrics and Gerontology","city":"Ōbu","state":"Aichi-ken","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Mie University Hospital","city":"Tsu","state":"Mie-ken","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital","city":"Tokyo","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Katsuhiro Kato, M.D. Ph.D.","phone":"+81 52 744 2150","email":"kato.katsuhiro.x2@f.mail.nagoya-u.ac.jp"},{"name":"RELIEF Trial Coordinating Office","phone":"+81 52 744 2942","email":"relief-office@med.nagoya-u.ac.jp"}],"primaryOutcomes":["Change From Baseline in serum NT-proBNP"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["nagoya-japan","bu-japan","tsu-japan","tokyo-japan"],"enrichment":{"headline":"Phase 2: testing Tamibarotene for HFpEF - Heart Failure With Preserved Ejection Fraction","inPlainEnglish":"This study will measure the effect of 12 weeks of treatment with tamibarotene compared with dummy treatment (placebo) on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).","whoItsFor":["Ages 26 Years to any","2\\. Patients with LVEF of 50% or more as determined by echocardiography at screening","3\\. Patients with an NT-proBNP level of 300 pg/mL or more at screening (or 600 pg/mL or more for patients with atrial fibrillation at screening)","5\\. Patients receiving any of the following medications whose dosage regimen has remained unchanged for at least 4 weeks prior to the initiation of investigational product administration:","・Diuretics,SGLT2 inhibitors, ARNIs, ARBs, ACE inhibitors, MRAs, beta-blockers, digitalis preparations, HCN channel blockers, Soluble guanylate cyclase stimulators","6\\. Patients with eGFR of 30 mL/min/1.73 m² or more at screening","7\\. Patients with a body-mass index (BMI) of less than 45 kg/m² at screening","9\\. Patients who agree to comply with the applicable requirement(s) below:"],"whoShouldSkip":["1\\. Patients diagnosed with acute heart failure, atrial fibrillation, or atrial flutter with a resting heart rate greater than 110 bpm within 4 weeks prior to enrollment","2\\. Patients with a history of myocardial infarction or unstable angina within 12 weeks prior to enrollment","4\\. Patients who have undergone PCI, CABG, valvuloplasty, valve replacement surgery, catheter ablation, implantation of an ICD, CRT, or any other cardiac surgery within 12 weeks prior to enrollment, or who are expected to require any of these procedures during the study period","5\\. Patients who have received mechanical circulatory support within 12 weeks prior to enrollment","6\\. Patients with a history of stroke or transient ischemic attack within 12 weeks prior to enrollment","7\\. Patients with evidence of increased bleeding tendency or coagulation abnormalities, including thromboembolic disorders or hemorrhagic disorders (except for patients whose condition is adequately controlled with anticoagulants, antiplatelet agents, or similar medications)","8\\. Patients with pulmonary diseases, including primary pulmonary hypertension, chronic thromboembolic pulmonary hypertension, COPD, or interstitial lung disease"],"whatHappens":"If you join, the listed intervention(s) are Tamibarotene, or Placebo. The registry lists allocation as randomized. This study will measure the effect of 12 weeks of treatment with tamibarotene compared with dummy treatment (placebo) on N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in patients with heart failure with preserved ejection fraction (HFpEF).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 90 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.427Z"},{"nctId":"NCT07856225","title":"Clinical and Therapeutic Outcomes by Molecular Subtype in Breast Cancer","officialTitle":"Evaluation of Clinical and Therapeutic Outcomes According to Molecular Subtype in Patients With Breast Cancer: Experience of Fundación Santa Fe de Bogotá","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fundación Santa Fe de Bogota","sponsorClass":"OTHER","summary":"Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments. In Colombia, there is limited information that integrates the clinical, treatment, sociodemographic and contextual characteristics of each subtype, and limited data on the direct medical costs of breast cancer care.\n\nThis retrospective cohort study will review the medical records of women 18 years or older with biopsy-confirmed breast cancer and a documented molecular subtype who were treated at Fundación Santa Fe de Bogotá (Bogotá, Colombia) between January 1, 2014 and December 31, 2024. It will describe each molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched, triple-negative and HER2-low) and evaluate the association of clinical, molecular and treatment characteristics with overall survival, progression-free survival, recurrence, treatment response and grade 3-4 adverse events. It will also explore the impact of the COVID-19 pandemic and health insurance regimen on outcomes, and estimate direct medical costs of breast cancer care by clinical stage and phase of care. The investigators will not assign or modify any treatment.","conditions":["Breast Neoplasms","Triple Negative Breast Neoplasms","HER2-Positive Breast Cancer","Hormone Receptor-Positive Breast Cancer"],"keywords":["Molecular Subtype","Luminal A","Luminal B","HER2-Enriched","Triple-Negative","HER2-Low","Ki-67","CDK4/6 Inhibitors","Anti-HER2 Therapy","COVID-19","Health Insurance","Cost of Illness","Micro-Costing","Colombia"],"interventions":[{"type":"DRUG","name":"CDK4/6 Inhibitors"},{"type":"DRUG","name":"Anti-HER2 Therapy"},{"type":"OTHER","name":"Standard Breast Cancer Treatment"}],"enrollment":370,"startDate":"2025-12-01","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients older than 18 years with a histopathologically confirmed diagnosis of breast cancer.\n* Treated at Fundación Santa Fe de Bogotá between January 1, 2014 and December 31, 2024.\n* Available record of the tumor molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched or triple-negative), determined by immunohistochemistry and/or in situ hybridization.\n\nExclusion Criteria:\n\n* Metastatic tumors from another primary site involving the breast (for example, breast metastases from another primary tumor).\n* Lesions of uncertain malignant potential or in situ tumors.\n* Incomplete or missing information on molecular subtype, treatment received or clinical outcomes.\n* Oncology follow-up outside the institution without adequate traceability of clinical outcomes.","locations":[{"facility":"Hospital Universitario Fundación Santa Fe de Bogotá","city":"Bogotá","state":"Bogota D.C.","country":"Colombia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erick Andrés Cantor Rizo, MD","phone":"+57 601 6030303","email":"erick.cantor@fsfb.org.co"}],"primaryOutcomes":["Overall Survival"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["bogot-colombia"],"enrichment":{"headline":"Not a traditional drug phase: testing CDK4/6 Inhibitors for Breast Neoplasms","inPlainEnglish":"Breast cancer is the most common cancer in women worldwide. Its molecular classification, based on hormone receptors (estrogen and progesterone), HER2 and Ki-67, defines subtypes with different prognoses and treatments.","whoItsFor":["Ages 18 Years to any","Patients older than 18 years with a histopathologically confirmed diagnosis of breast cancer","Treated at Fundación Santa Fe de Bogotá between January 1, 2014 and December 31, 2024","Available record of the tumor molecular subtype (luminal A, luminal B HER2-negative, luminal B HER2-positive, HER2-enriched or triple-negative), determined by immunohistochemistry and/or in situ hybridization"],"whoShouldSkip":["Metastatic tumors from another primary site involving the breast (for example, breast metastases from another primary tumor)","Lesions of uncertain malignant potential or in situ tumors","Incomplete or missing information on molecular subtype, treatment received or clinical outcomes","Oncology follow-up outside the institution without adequate traceability of clinical outcomes"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 370 people at Bogotá. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:27.723Z"},{"nctId":"NCT07856420","title":"A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment","officialTitle":"A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety, and Tolerability of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Patients With Generalized Anxiety Disorder Who Have an Inadequate Response to Generalized Anxiety Disorder Treatment and an Open-label Long-term Extension Treatment With JNJ-99245354 (ITI-1284)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Intra-Cellular Therapies, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to placebo when given as an additional (adjunctive) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).","conditions":["Generalized Anxiety Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"JNJ-99245354"},{"type":"DRUG","name":"Placebo"}],"enrollment":705,"startDate":"2026-09-29","completionDate":"2030-09-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline\n* Medically stable on the basis of clinical laboratory tests performed at screening\n* History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms\n* Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial\n* Body mass index (BMI) within the range 19-40 kilogram per meter squared (kg/m\\^2) (inclusive)\n\nExclusion criteria:\n\n* Within the participant's lifetime, has one of the following confirmed diagnostic and statistical manual of mental disorders (5th edition) (DSM-5) text revision (TR) psychiatric diagnoses: a. schizophrenia, schizoaffective disorder, schizophreniform disorder or other psychotic disorder; b. bipolar disorder\n* Within 6 months of screening, has a confirmed DSM-5-TR psychiatric diagnosis other than GAD, including: a. other anxiety disorders (except simple phobias and social anxiety disorder); b. moderate or severe alcohol or substance use disorders (excluding nicotine); d. moderate or severe major depressive disorder; e. any other psychiatric condition (except for mild major depressive disorder \\[MDD\\]) that has been the main focus of treatment\n* Montgomery-asberg depression rating scale (MADRS) total score greater than (\\>)18 at screening or baseline\n* Lifetime history of inadequate response to \\>3 of the approved treatments for GAD at an adequate dose and for an adequate duration\n* The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline","locations":[{"facility":"Inland Psychiatric Medical Group Inc","city":"Temecula","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nuovida Research Center","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Voltaire Clinical Research","city":"Springfield","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fieve Clinical Research Inc","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact","phone":"844-434-4210","email":"Participate-In-This-Study1@its.jnj.com"}],"primaryOutcomes":["Change from Baseline to End of Week 6 in Hamilton Anxiety Rating (HAM-A) Scale Total Score"],"hasResults":false,"conditionSlugs":["anxiety"],"drugSlugs":[],"locationSlugs":["temecula-california","miami-florida","springfield-massachusetts","new-york-new-york"],"enrichment":{"headline":"Phase 3: testing JNJ-99245354 for Generalized Anxiety Disorder","inPlainEnglish":"This study wants to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to dummy treatment (placebo) when given as an additional (added on top of your current treatment) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).","whoItsFor":["Ages 18 Years to any","Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and at baseline","Medically stable on the basis of clinical laboratory tests performed at screening","History of inadequate response to at least 1 generalized anxiety disorder (GAD)-approved treatment taken at an adequate dose and duration as specified in the protocol for the treatment of ongoing GAD symptoms","Is currently an outpatient and is anticipated to maintain outpatient status for the duration of the double blind (DB) treatment period of the trial","Body mass index (body-mass index (BMI)) within the range 19-40 kilogram per meter squared (kg/m\\^2) (inclusive)"],"whoShouldSkip":["Montgomery-asberg depression rating scale (MADRS) total score greater than (\\>)18 at screening or baseline","Lifetime history of inadequate response to \\>3 of the approved treatments for GAD at an adequate dose and for an adequate duration","The participant is taking more than 1 anti depressive therapy (ADT) or is taking ADT + buspirone at screening, regardless of indication, and is unable or unwilling to discontinue additional ADT (or buspirone) prior to baseline"],"whatHappens":"If you join, the listed intervention(s) are JNJ-99245354, or Placebo. The registry lists allocation as randomized. This study wants to assess if JNJ-99245354 administered once daily works better to reduce anxiety compared to dummy treatment (placebo) when given as an additional (added on top of your current treatment) therapy in participants with generalized anxiety disorder (GAD; a mental health condition defined by uncontrollable, and excessive worry about everyday events for a long period of time).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 705 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.346Z"},{"nctId":"NCT07857616","title":"SI-B036-ST-101 in Advanced/Metastatic Solid Tumors","officialTitle":"SI-B036-ST-101: A Multicenter, Open-Label, Phase 1/1b, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SI-B036 in Adult Patients With Advanced/Metastatic Solid Tumors That Are Refractory to Standard Therapies","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"SystImmune Inc.","sponsorClass":"INDUSTRY","summary":"The objective of the study is to evaluate the safety and tolerability of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.","conditions":["Locally Advanced /Metastatic Solid Tumors","Locally Advanced / Metastatic Solid Tumors","Metastatic Solid Cancers","Non Small Cell Lung Cancer","Lung Cancer","Melanoma","Ovarian","NSCLC"],"keywords":["PD-L1","VEGFR-2","First in Human","FIH"],"interventions":[{"type":"DRUG","name":"SI-B036"}],"enrollment":424,"startDate":"2026-07-30","completionDate":"2028-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Documented locally advanced or metastatic solid tumor(s) not amenable to curative surgery or radiation and have received at least 1 line of standard therapy, including adjuvant/neoadjuvant treatment, or whose cancer is considered refractory to the standard of care (SOC) or for which no standard treatment is available.\n* Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V6.0.\n* Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%.\n* Has adequate organ function before enrollment\n\nPART C Additional Inclusion Criteria (Dose Expansion Only)\n\n\\- For immuno-oncology (IO)-exposed non-small cell lung cancer (NSCLC): histologically or cytologically confirmed unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) in subjects who are previously exposed to immune checkpoint inhibitor (ICI) therapy (IO-exposed) and whose disease is refractory to standard of care (SOC) therapy or for whom no appropriate standard treatment options are available. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor IO naïve NSCLC: histologically or cytologically confirmed unresectable locally advanced or metastatic NSCLC in subjects who are not previously exposed to ICI therapy. Subjects must also have PD-L1 expression ≥1% (tumor proportion score \\[TPS\\]) as determined by an FDA-approved assay. In addition, subjects must have received at least one prior line of platinum therapy.\n\nFor Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy.\n\nFor Ovarian Cancer: has histologic documentation of epithelial ovarian, primary peritoneal, or fallopian tube cancer that has progressed or relapsed on or after a previous chemotherapy with or without a poly (ADP-ribose) polymerase (PARP) inhibitor. Prior bevacizumab treatment is allowed.\n\nExclusion Criteria:\n\n* Chemotherapy, biological therapy, immunotherapy, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other antitumor therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first administration; radical radiotherapy, major surgery within 4 weeks prior to the first administration; mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration; oral drugs such as Ticio such as capecitabine, or palliative radiotherapy within 2 weeks prior to initial administration.\n* Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer).\n* Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted.\n* Participants with history of severe heart disease within 6 months before enrollment.\n* Participants with prolonged QT interval (QTcF \\>470 msec), complete left bundle branch block, Grade 3 atrioventricular block, or a history of additional risk factors for Torsades de Pointes (TdP) or any current concomitant medication known to prolong the QT/QTc interval or cause TdP.\n* Other malignant tumors were diagnosed within 5 years prior to the first administration.\n* For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded.\n* Participants with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]), stroke, or transient ischemic attack (TIA) within 6 months before screening.\n* Participants with active or recent clinically significant bleeding are excluded, or who are at risk of bleeding due to clinically significant platelet abnormalities or coagulopathy, or who require full-dose anticoagulation or high-intensity antiplatelet therapy on high dose nonsteroidal anti-inflammatory drugs (NSAIDs).\n* Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening.\n* Participants with advanced/clinically significant lung diseases, who have a history of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening, or concurrent pulmonary disease resulting in severe impaired respiratory function.\n* Participants with primary tumors in the central nervous system (CNS), active or untreated CNS metastases or carcinomatous meningitis should be excluded. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and no requirements for corticosteroids 14 days prior to Screening.\n* Participant with active or untreated hemorrhagic CNS lesions.\n* Participants with a history of anaphylaxis or severe hypersensitivity reactions.\n* Previous organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Subjects with recent surgery, biopsy, or invasive procedures without adequate wound healing prior to study enrollment.\n* Participated in another clinical trial within 4 weeks prior to first dose of study treatment.\n* Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.\n* History of fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to the first dose.\n* Participant with moderate or major hemoptysis history.\n* Participant has tumors invading large blood vessels\n* Other conditions that the Investigator or sponsor believes are not suitable for participating in this clinical trial.","locations":[{"facility":"Yale Cancer Center","city":"New Haven","state":"Connecticut","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists Lake Nona","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Cancer Specialists Sarasota","city":"Sarasota","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"OU Health Stephenson Cancer Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sarah Cannon Research Institute - Oncology Partners","city":"Nashville","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mary Crowley Cancer Research","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"MD Anderson","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Stephanie Yee","phone":"425-453-6841","email":"stephanie.yee@systimmune.com"}],"primaryOutcomes":["Participants with Dose-Limiting Toxicities","Participants with Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and Treatment-Emergent Adverse Events (TEAEs)","Participants with abnormal physical examination findings","Participants with abnormal lab results","Participants with abnormal ECG reading","To determine the maximum tolerated dose (MTD) if reached or minimum safe and pharmacologically effective dose (MSED)."],"hasResults":false,"conditionSlugs":["lung-cancer","melanoma"],"drugSlugs":[],"locationSlugs":["new-haven-connecticut","orlando-florida","sarasota-florida","oklahoma-city-oklahoma","nashville-tennessee","dallas-texas","houston-texas"],"enrichment":{"headline":"Phase 1: testing SI-B036 for Locally Advanced /Metastatic Solid Tumors","inPlainEnglish":"The objective of the study is to measure the whether it is safe and how hard side effects are to live with of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.","whoItsFor":["Ages 18 Years to any","Toxicity of previous antitumor therapy has returned to level ≤1 as defined by National Cancer Institute (NCI) Common Terminology Criteria for side effects (CTCAE) V6.0","Has no serious cardiac dysfunction and left ventricular ejection fraction ≥50%","Has adequate organ function before enrollment","PART C Additional who can join (Dose Expansion Only)","For Melanoma: histologically confirmed unresectable or metastatic melanoma with prior treatment with an immune checkpoint inhibitor regimen and documented disease progression following such therapy"],"whoShouldSkip":["Received systemic immunostimulatory therapy within 4 weeks prior to the first dose or is still within 5 half-lives of the treatment (whichever is longer)","Received immunosuppressive drugs within 2 weeks prior to the first dose. The use of topical, inhaled, and locally injected steroids is permitted","Participants with history of severe heart disease within 6 months before enrollment","Other malignant tumors were diagnosed within 5 years prior to the first administration","For the dose escalation portion of the study only, participants with a primary diagnosis of lung cancer are excluded","Participants with a thromboembolic event (eg, deep vein thrombosis \\[DVT\\] or pulmonary embolism \\[PE\\]), stroke, or transient ischemic attack (TIA) within 6 months before screening","Active autoimmune diseases and inflammatory diseases. For autoimmune conditions that are active but stable and low-grade on systemic therapy, discussion with the medical monitor is required prior to screening"],"whatHappens":"If you join, the listed intervention(s) are SI-B036. The registry lists allocation as na. The objective of the study is to measure the whether it is safe and how hard side effects are to live with of SI-B036 in participants with solid tumors who have received at least one prior line of therapy for advanced disease.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 424 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.809Z"},{"nctId":"NCT07858266","title":"Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for Emergency Department Patients With Glasgow Coma Scale 15 Traumatic Brain Injury (PIONEER-Prognosis)","officialTitle":"Deployment of a Novel NINDS Clinical, Biomarker, Imaging, and Modifiers (CBI-M) Classification Framework for ED Patients With GCS 15 TBI (PIONEER-Prognosis)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Michigan","sponsorClass":"OTHER","summary":"This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.","conditions":["Traumatic Brain Injury"],"keywords":["traumatic brain injury","prognosis","biomarker","wearable","gfap","uch-l1","GCS 15 TBI","whoop"],"interventions":[],"enrollment":500,"startDate":"2026-10-20","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria.\n* Enrollment within 24 hours of injury.\n* Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment.\n* Consent to study procedures, including:\n\n  * Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1).\n  * Continuous use of a health-monitoring device for 3 months.\n  * Follow-up assessments by telephone at 14 days and 90 days.\n  * Completion of a daily symptom inventory via WHOOP/smartphone.\n\nExclusion Criteria:\n\n* Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score \\<8 if assessed before the injury.\n* High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state.\n* Pregnancy at the time of enrollment.\n* Inability to speak English or Spanish, which would prevent completion of the required assessments.","locations":[{"facility":"Harbor-UCLA Medical Center","city":"Torrance","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Michigan","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Macomb","city":"Clinton Township","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Henry Ford Hospital","city":"Detroit","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Oregon Health & Science University","city":"Portland","state":"Oregon","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Devon Newman, MS","phone":"734-764-1602","email":"devonn@med.umich.edu"}],"primaryOutcomes":["Functional recovery"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["torrance-california","ann-arbor-michigan","clinton-township-michigan","detroit-michigan","portland-oregon"],"enrichment":{"headline":"Deployment of a Novel National Institute of Neurological Disorders and Stroke Clinical, Biomarker, Imaging,…","inPlainEnglish":"This study is being done to learn how information from blood tests, medical records, and wearable devices that track sleep, activity, and heart rate can help predict how people recover after a concussion. The goal is to improve how doctors monitor recovery and give patients better information about what to expect after a head injury.","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of mild traumatic brain injury (TBI), as defined by the 2023 American Congress of Rehabilitation Medicine (ACRM) criteria","Enrollment within 24 hours of injury","Glasgow Coma Scale (GCS) score of 15 at emergency department (ED) enrollment","Consent to study procedures, including:","Blood collection for biomarker measurement, including glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1)","Continuous use of a health-monitoring device for 3 months","Follow-up assessments by telephone at 14 days and 90 days"],"whoShouldSkip":["Pre-existing neurological disability or pre-injury condition that would have resulted in a Glasgow Outcome Scale-Extended (GOS-E) score \\<8 if assessed before the injury","High risk of loss to follow-up, including patients without a reliable phone, those experiencing homelessness, those who are incarcerated, or those who are wards of the state","Pregnancy at the time of enrollment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at 5 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.205Z"},{"nctId":"NCT07858565","title":"Quality of Life, Safety and Compliance of Patients Using Monotherapy or Combinatorial Therapy With Quetiapine for Treatment of Schizophrenia or Bipolar Affective Disorder","officialTitle":"Study of Quality of Life, Safety and Compliance During Treatment of Schizophrenia or Bipolar Affective Disorder, in Patients Using the Drug Kvepin® (Quetiapine) as Monotherapy or Combination Therapy With Other Antipsychotics (Ispitivanje Kvalitete života, Sigurnosti i Saradljivosti u Toku liječenja Shizofrenije Ili Bipolarnog Afektivnog poremećaja, Kod Pacijenata Koji Koriste Lijek Kvepin® (Kvetiapin) Kao Monoterapiju Ili Kombinovanu Terapiju sa Drugim Antipsihoticima)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Bosnalijek D.D","sponsorClass":"INDUSTRY","summary":"The goal of this observational study is to evaluate the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine monotherapy or in combination with another antipsychotic/antipsychotics. The main outcome measures are:\n\n* quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)\n* safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction\n* therapy adherence using the Medication Adherence Rating Scale (MARS).\n\nThe subjects will be divided into two groups:\n\n1. Newly diagnosed patients with a diagnosis of schizophrenia or bipolar affective disorder whose individual therapeutic approach, based on the clinical assessment of the research physician, includes one of the following therapies:\n\n   1. monotherapy with the drug quetiapine\n   2. combined antipsychotic therapy with quetiapine and aripiprazole\n   3. combined antipsychotic therapy with quetiapine and haloperidol\n2. Patients with a diagnosis of schizophrenia or bipolar affective disorder who are on therapy with one of the antipsychotics (aripiprazole or haloperidol), and who, based on the clinical assessment of the investigator, require adjunctive quetiapine therapy. This group will include two subgroups of patients:\n\n   1. combined antipsychotic therapy with quetiapine and aripiprazole\n   2. combined antipsychotic therapy with quetiapine and haloperidol Recruitment of subjects will be carried out by physicians/researchers based on the patient's history and diagnosis. The diagnosis of schizophrenia or bipolar affective disorder will be based on the standard diagnostic criteria in medical practice (validated measurement scales in psychiatry - Young's Mania Scale, Beck Depression Scale and PANNS Schizophrenia Scale).\n\nPatients will have four visits to physician/researcher:\n\n1. First visit - baseline at which patient will be included in the study\n2. Second visit - 4 months after the baseline\n3. Third visit - 8 months after the baseline\n4. Fourth visit - 12 months after the baseline","conditions":["Schizophrenia","Bipolar Affective Disorder"],"keywords":[],"interventions":[{"type":"DRUG","name":"Quetiapine (drug)"},{"type":"DRUG","name":"quetiapine + aripiprazole"},{"type":"DRUG","name":"quetiapine + haloperidol"}],"enrollment":500,"startDate":"2025-10-30","completionDate":"2027-04","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Persons over 18 years of age and under 65 years of age.\n* Schizophrenia or bipolar affective disorder established by the usual diagnostic criteria applied in a psychiatric clinic or hospital ward/unit within the clinic or outpatient.\n* Patients who are treated as outpatients, inpatients or have been discharged from the clinic/hospital with a recommendation for quetiapine monotherapy or combination therapy of quetiapine with aripiprazole or haloperidol. Recommended by a specialist psychiatrist/neuropsychiatrist in clinical and hospital centers and through specialist-consultant outpatient clinics in Bosnia and Herzegovina.\n\nExclusion Criteria:\n\n* Persons younger than 18 years and older than 65 years\n* Hypersensitivity to the components of the drug\n* Positive history of angioneurotic edema\n* Pregnancy\n* Breastfeeding\n* Simultaneous use with cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone\n* Patients who are planning to become pregnant in the near future\n* Diagnosed medical conditions that may constitute a contraindication for the use of the drug quetiapine\n\nWithdrawal Criteria:\n\n* Deterioration of the underlying disease that requires therapy discontinuation\n* Development of serious adverse events requiring therapy discontinuation\n* Occurence of pregnancy\n* Development of another disease that affects the course of the study","locations":[{"facility":"Clinic of Psychiatry, University Clinical Center of Sarajevo","city":"Sarajevo","state":"","country":"Bosnia and Herzegovina","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Halima Karakaš","phone":"+38762478535","email":"HalimaK@Bosnalijek.ba"},{"name":"Una Glamoclija, PhD","phone":"+38761147401","email":"UnaG@Bosnalijek.ba"}],"primaryOutcomes":["Measurement of quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL)-BREF"],"hasResults":false,"conditionSlugs":["depression","schizophrenia"],"drugSlugs":[],"locationSlugs":["sarajevo-bosnia-and-herzegovina"],"enrichment":{"headline":"Not a traditional drug phase: testing Quetiapine (drug) for Schizophrenia","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to measure the quality of life, drug safety and therapy compliance of schizophrenia or bipolar affective disorder patients during the treatment with quetiapine this drug alone or in combination with another antipsychotic/antipsychotics. The main outcome measures are: * quality of life using the World Health Organization Quality of Life questionnaire (WHOQOL) * safety through the monitoring of the incidence of possible adverse drug events by the researcher, with the assessment of the association between the administration of the drug and the occurrence of an adverse reaction * therapy adherence using the Medication Adherence Rating Scale (MARS).","whoItsFor":["Ages 18 Years to 65 Years","Persons over 18 years of age and under 65 years of age","Schizophrenia or bipolar affective disorder established by the usual diagnostic criteria applied in a psychiatric clinic or hospital ward/unit within the clinic or outpatient"],"whoShouldSkip":["Persons younger than 18 years and older than 65 years","Hypersensitivity to the components of the drug","Positive history of angioneurotic edema","Simultaneous use with cytochrome P450 3A4 inhibitors, such as HIV-protease inhibitors, azole antifungals, erythromycin, clarithromycin and nefazodone","Patients who are planning to become pregnant in the near future","Diagnosed medical conditions that may constitute a contraindication for the use of the drug quetiapine","Withdrawal Criteria:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Sarajevo. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.742Z"},{"nctId":"NCT07858864","title":"GLP-1 Receptor Agonist Use and Sarcopenia in Obese Individuals Without Diabetes","officialTitle":"Evaluation of the Relationship Between GLP-1 Receptor Agonist Use and Sarcopenia in Non-Diabetic Obese Individuals: A Prospective Descriptive Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istanbul Saglik Bilimleri University","sponsorClass":"OTHER","summary":"Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual GLP-1/GIP agonists such as semaglutide and tirzepatide produce marked weight loss in people with obesity, with reported reductions of about 15-20%. Rapid weight loss may reduce not only fat mass but also lean body mass and skeletal muscle mass, raising concern about sarcopenia and sarcopenic obesity. Evidence in non-diabetic obese individuals is limited and inconsistent. This prospective descriptive study will assess muscle mass, muscle strength, physical performance and sarcopenia risk in non-diabetic obese adults starting GLP-1 RA therapy, at baseline and at month 3, and will examine how weight loss relates to changes in body composition.","conditions":["Obesity","Sarcopenia"],"keywords":["GLP-1 receptor agonist","Sarcopenia","Sarcopenic obesity","SARC-F Handgrip strength"],"interventions":[{"type":"DRUG","name":"GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment."}],"enrollment":42,"startDate":"2026-05-30","completionDate":"2026-11-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of obesity (BMI \\>30 kg/m²)\n* Currently using a GLP-1 RA\n* No hearing, speech or cognitive impairment\n* Not receiving treatment for major depressive disorder and not using antidepressants\n* Verbal consent to participate\n\nExclusion Criteria:\n\n* Diagnosis of diabetes\n* History of chronic kidney failure, chronic liver disease, decompensated heart failure or malignancy\n* Pregnancy or breastfeeding\n* Walking impairment\n* Not meeting inclusion criteria or unwilling to participate","locations":[{"facility":"Kanuni Sultan Süleyman Training and Research Hospital","city":"Istanbul","state":"Kucukcekmece","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"GÜLDEN ANATACA","phone":"05059284244","email":"ganataca@yahoo.com"}],"primaryOutcomes":["Change in SARC-F (Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls) total score"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: testing GLP-1 receptor agonist (e.g., semaglutide, tirzepatide) - prescribed by the treating physician as standard care; the study does not assign or alter treatment. for Obesity","inPlainEnglish":"Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and dual GLP-1/GIP agonists such as semaglutide and tirzepatide produce marked weight loss in people with obesity, with reported reductions of about 15-20%. Rapid weight loss may reduce not only fat mass but also lean body mass and skeletal muscle mass, raising concern about sarcopenia and sarcopenic obesity.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Diagnosis of obesity (body-mass index (BMI) \\>30 kg/m²)","Currently using a GLP-1 RA","No hearing, speech or cognitive impairment","Not receiving treatment for major depressive disorder and not using antidepressants","Verbal consent to participate"],"whoShouldSkip":["Diagnosis of diabetes","History of chronic kidney failure, chronic liver disease, decompensated heart failure or malignancy","Pregnancy or breastfeeding"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 42 people at Istanbul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.736Z"},{"nctId":"NCT07860203","title":"Stellate Ganglion Block and Dexmedetomidine for Postoperative Sleep in Women Undergoing Laparoscopic Gynecologic Surgery","officialTitle":"Effects of Stellate Ganglion Block Combined With Dexmedetomidine on Postoperative Sleep Quality in Patients Undergoing Laparoscopic Gynecological Surgery: A Randomized Controlled 2×2 Factorial Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Catherin Zhang","sponsorClass":"OTHER","summary":"Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.\n\nThis trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben","conditions":["Uterine Fibroids (Leiomyoma)","Adenomyosis of Uterus","Endometriosis","Endometrial Cancer","Cervical Cancer","Ovarian Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"DEX 0.2 μg/kg/h."},{"type":"PROCEDURE","name":"SGB"},{"type":"DRUG","name":"0.9% Sodium Chloride (Placebo)"},{"type":"PROCEDURE","name":"Sham Stellate Ganglion Block"}],"enrollment":100,"startDate":"2026-10","completionDate":"2026-12","sex":"FEMALE","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with American Society of Anesthesiologists (ASA) physical status I-III;\n2. Age 18-75 years;\n3. Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids).\n\nExclusion Criteria:\n\n1. Preoperative sore throat or hoarseness;\n2. History of upper respiratory tract infection within the previous 2 weeks;\n3. Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening \\<3 finger breadths, etc.);\n4. Severe preoperative cardiac, hepatic, renal, or other organ dysfunction;\n5. Allergy to the local anesthetic used in the study, infection at the puncture site, or coagulation abnormalities;\n6. Cognitive impairment, hearing impairment, language impairment, a history of psychiatric illness, or difficulty communicating or cooperating because of a psychiatric disorder.","locations":[{"facility":"Huai'an Second People's Hospital","city":"Huai'an","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jun Wang","phone":"+86 19552153837","email":"1961440528@qq.com"}],"primaryOutcomes":["St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery","Total Sleep Time 1 Day Before Surgery","Wake After Sleep Onset 1 Day Before Surgery","Sleep Efficiency 1 Day Before Surgery","St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 1","Total Sleep Time on Postoperative Day 1","Wake After Sleep Onset on Postoperative Day 1","Sleep Efficiency on Postoperative Day 1","St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 2","Total Sleep Time on Postoperative Day 2","Wake After Sleep Onset on Postoperative Day 2","Sleep Efficiency on Postoperative Day 2"],"hasResults":false,"conditionSlugs":["ovarian-cancer","cervical-cancer","endometrial-cancer","als","endometriosis"],"drugSlugs":[],"locationSlugs":["huaian-china"],"enrichment":{"headline":"Not a traditional drug phase: testing DEX 0.2 μg/kg/h. for Uterine Fibroids (Leiomyoma)","inPlainEnglish":"Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs. This trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben","whoItsFor":["Ages 18 Years to 75 Years","Women only","Patients with American Society of Anesthesiologists (ASA) physical status I-III;","Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids)"],"whoShouldSkip":["Preoperative sore throat or hoarseness;","History of upper respiratory tract infection within the previous 2 weeks;","Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening \\<3 finger breadths, etc.);","Severe preoperative cardiac, hepatic, renal, or other organ dysfunction;","Allergy to the local anesthetic used in the study, infection at the puncture site, or coagulation abnormalities;","Cognitive impairment, hearing impairment, language impairment, a history of psychiatric illness, or difficulty communicating or cooperating because of a psychiatric disorder"],"whatHappens":"If you join, the listed intervention(s) are DEX 0.2 μg/kg/h., SGB, or 0.9% Sodium Chloride (Placebo). The registry lists allocation as randomized. Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Huai'an. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.112Z"},{"nctId":"NCT07861230","title":"Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing","officialTitle":"Characterization of the Tongue in Children With Obstructive Sleep-disordered Breathing","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Université Catholique de Louvain","sponsorClass":"OTHER","summary":"The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences. Although adenotonsillectomy remains the treatment of choice, it fails in a substantial proportion of cases because of persistent obstruction at other sites, the tongue base being involved in one third of these cases. Therefore, a better characterization of the tongue in children with oSDB is needed, since the extent to which its structure and function contribute to upper airway obstruction in this population remains largely unknown.\n\nOur team has established the reproducibility of tongue function measurements in healthy children and is currently building a reference database. What is still lacking is an assessment of tongue structure and function in children with oSDB. Such data would allow comparison with healthy children, thereby improving the understanding of oSDB pathophysiology and informing clinical management.\n\nPrimary objective: To describe tongue structure and function in children with oSDB.\n\nSecondary objective: To compare tongue structure and function between children with oSDB and healthy children, using data from a previous study conducted in healthy children (TMAC study, UCLouvain).","conditions":["Obstructive Sleep Disordered Breathing"],"keywords":["obstructive sleep disordered breathing","children","sleep apnea","tongue"],"interventions":[{"type":"OTHER","name":"Cross-sectional assessment"}],"enrollment":39,"startDate":"2026-10-01","completionDate":"2028-09-01","sex":"ALL","minAge":"4 Years","maxAge":"17 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 4 to 17 years\n* Scheduled polysomnography, or polysomnography performed within the past 6 months\n* Positive Pediatric Sleep Questionnaire (8 \"yes\" answers or more)\n\nExclusion Criteria:\n\n* Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III\n* Any condition that could interfere with the assessments","locations":[{"facility":"CHC MontLégia hospital","city":"Liège","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"William Poncin, Professor","phone":"0471 90 66 23","email":"william.poncin@uclouvain.be"}],"primaryOutcomes":["Tongue strength assessment"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["li-ge-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Cross-sectional assessment for Obstructive Sleep Disordered Breathing","inPlainEnglish":"The tongue plays a key role in maintaining upper airway patency during sleep, mainly through the genioglossus, the principal pharyngeal dilator muscle. Its dysfunction may be linked to the development of obstructive sleep-disordered breathing (oSDB), a condition affecting more than one in ten children and associated with cardiovascular and cognitive consequences.","whoItsFor":["Ages 4 Years to 17 Years","Scheduled polysomnography, or polysomnography performed within the past 6 months","Positive Pediatric Sleep Questionnaire (8 \"yes\" answers or more)"],"whoShouldSkip":["Any neurological, syndromic, or malformative comorbidity that would classify the obstructive sleep disorder as Type III","Any condition that could interfere with the assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 39 people at Liège. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.943Z"},{"nctId":"NCT07862205","title":"EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression","officialTitle":"Closed-Loop Electroencephalography Optimized Transcranial Magnetic Stimulation Pilot Study for Advanced Treatment Outcomes in Adults With Major Depressive Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Mayo Clinic","sponsorClass":"OTHER","summary":"The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (MDD).\n\nThis is a feasibility study to test a \"closed-loop\" procedure which guides the timing of this FDA-cleared form of TMS. Each participant will receive an active experimental treatment, and the timing of the TMS pulses will be at one of three phases in the brain wave of interest.","conditions":["Major Depressive Disorder (MDD)","Treatment Resistant Depression","Major Depression"],"keywords":["Transcranial Magnetic Stimulation (TMS)","Major Depressive Disorder","Intermittent Theta Burst Stimulation (iTBS)","Adults with MDD"],"interventions":[{"type":"DEVICE","name":"MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG"}],"enrollment":60,"startDate":"2026-11-02","completionDate":"2029-11","sex":"ALL","minAge":"22 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Outpatients\n* Voluntary patient seeking treatment with the capacity to consent\n* 22-60 years of age\n* Have Major Depressive Disorder (MDD) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57\n* Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable\n* Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS\n* In a current episode of MDD with duration of at least 4 weeks but less than 2 years\n* Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening\n* Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire\n* On a medically acceptable form of birth control if capable of becoming pregnant\n* Are able to adhere to the protocol and treatment schedule\n* Currently and throughout study participation is under the care of a licensed psychiatrist and/or other mental health care provider and agrees to promptly inform the investigator or study staff of any change in such provider(s).\n* Agrees to allow any and all forms of communication between the investigators and study staff with any healthcare provider who has provided service to the patient/participant within at least two years of study enrollment for the purposes of eligibility confirmation or in case of a safety event.\n* Agrees to provide the name and verifiable contact information (email and mailing addresses, mobile and land-line phone numbers, as applicable) of at least two persons 22 years or older who reside within reasonable driving time of the patient's home address. Participant also agrees that research personnel are at liberty to contact these individuals if the participant is unable to be contacted.\n\nExclusion Criteria:\n\n* Have a history of a substance use disorder (including alcohol)\n* Within the past 3 months have a major medical illness, intracranial lesion or increased intracranial pressure, prior ischemic or hemorrhagic stroke, neurologic conditions with structural cerebral damage, stroke, multiple sclerosis, traumatic brain injury, epilepsy, a personal history of a seizure, or individuals with a family history of epilepsy or seizure in a first degree relative (please note that an individual with a first-degree relative with a history of epilepsy, or one or more seizures does not need to be excluded if the cause of epilepsy or seizure(s) is non-genetic (i.e., \"non-idiopathic\"), Alzheimer's and other neurodegenerative diseases, meningoencephalitis or intracerebral abscess, parenchymal or leptomeningeal cancers), moderate to severe heart disease, cardiac pacemaker, implanted devices, or implanted medication pumps\n* Contraindications for TMS or MRI\n* Have active suicidal intent, as determined by the Principal Investigator (PI) and/or is considered a moderate-high risk of suicide according to the Columbia-Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e., answers YES to Question 3 and NO to Question 6 (Moderate risk) or YES to Question 4, 5, or 6 (High risk))4 by the PI. (Columbia Suicide Severity Rating Scale.\n* Pregnant and lactating patients\n* As determined by the Principal Investigator (PI), has: (a) a lifetime history of mania or hypomania symptoms from any cause; (b) a medical condition or diagnosis, within 1 year of screening, that seems somewhat likely to cause such symptoms; or (c) scores 12 on the Young Mania Rating Scale.\n* Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms.\n* Patients taking bupropion/Wellbutrin or antipsychotics are excluded","locations":[{"facility":"Mayo Clinic","city":"Rochester","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Courtney Caves","phone":"507-255-0624","email":"wolf.courtney@mayo.edu"},{"name":"Sarah Purdy","phone":"507-266-3303","email":"purdy.sarah@mayo.edu"}],"primaryOutcomes":["Feasibility of closed-loop EEG guided iTBS in adult participants with MDD."],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["rochester-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG for Major Depressive Disorder (MDD)","inPlainEnglish":"The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (major depression). This is a feasibility study to test a \"closed-loop\" procedure which guides the timing of this FDA-cleared form of TMS.","whoItsFor":["Ages 22 Years to 60 Years","Voluntary patient seeking treatment with the capacity to consent","Have Major Depressive Disorder (major depression) single or recurrent episodes confirmed with the Mini-International Neuropsychiatric Interview (MINI)57","Failed to achieve a clinical response to an adequately dosed antidepressant as assessed with an Antidepressant Treatment History Form score of 3 or greater in the current episode or have had 2 separate trials of antidepressants that were intolerable","Have a score of 18 or higher on the Hamilton Depression Rating Scale (17 item) HDRS","In a current episode of major depression with duration of at least 4 weeks but less than 2 years","Have no initiation or dose change in any psychotropic medication or for the 4 weeks prior to screening","Have no clinically significant changes (as determined by the study investigators) in psychotherapeutic interventions for the 4 weeks prior to screening Can safely undergo TMS treatment based on the TMS Adult Safety Screen questionnaire"],"whoShouldSkip":["Have a history of a substance use disorder (including alcohol)","Contraindications for TMS or MRI","Pregnant and lactating patients","Based on the MINI interview have a lifetime diagnosis of bipolar I, bipolar II, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or any current psychotic symptoms","Patients taking bupropion/Wellbutrin or antipsychotics are excluded"],"whatHappens":"If you join, the listed intervention(s) are MagVenture TMS Therapy System with Localite Navigation System and actiCHamp EEG. The registry lists allocation as randomized. The purpose of this research is to see if an experimental treatment for depression called intermittent theta burst stimulation (iTBS), a form of transcranial magnetic stimulation (TMS) can be improved for better results using electroencephalography (EEG) recordings (brain waves) for individuals with Major Depressive Disorder (major depression).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Rochester. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.122Z"},{"nctId":"NCT07863180","title":"Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial","officialTitle":"Tributyrin for PSP: Phase 1b Virtual Trial - Feasibility Study","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Prabesh Kanel","sponsorClass":"OTHER","summary":"This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its safety and tolerability as a potential treatment. The goal of this research study is to see if a similar supplementation regimen and virtual testing is feasible for people with PSP.","conditions":["Parkinson Disease","Multiple System Atrophy","Progressive Supranuclear Palsy(PSP)"],"keywords":["short chain fatty acid","fecal microbiota transplantation","Butyric acid","Tributyrin"],"interventions":[{"type":"DRUG","name":"Tributyrin"},{"type":"DRUG","name":"Placebo"}],"enrollment":15,"startDate":"2026-10-01","completionDate":"2027-05","sex":"ALL","minAge":"45 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or Female, age 45 years and over.\n* Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including\n\n  1. Vertical supranuclear gaze palsy.\n  2. Repeated unprovoked falls OR tendency to fall on the pull test within 3 years.\n* Access to the internet and webcam for virtual visits.\n* Presence of a caregiver.\n\nExclusion Criteria:\n\n* Recent history of significant, uncontrolled GI disease such as Gastroesophageal reflux disease, colorectal cancer.\n* Significant metabolic or uncontrolled medical comorbidity.\n* Regular use of typical anti-cholinergic drugs.\n* Women of child-bearing potential, or who are pregnant and/or nursing.\n* Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory.\n* Any other condition or criterion that, in the opinion of the investigators, would preclude safe and meaningful participation in the study.","locations":[{"facility":"Domino's Farms","city":"Ann Arbor","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nathan Alexander","phone":"734-998-8422","email":"natealex@med.umich.edu"},{"name":"Robert Vangel, BSc","phone":"734-936-1168","email":"rvangel@med.umich.edu"}],"primaryOutcomes":["Tolerability of tributyrin","Safety of tributyrin"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["ann-arbor-michigan"],"enrichment":{"headline":"Phase 1 / Phase 2: testing Tributyrin for Parkinson Disease","inPlainEnglish":"This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its whether it is safe and how hard side effects are to live with as a potential treatment. The goal of this research study is to see if a similar supplementation regimen and virtual testing is feasible for people with PSP.","whoItsFor":["Ages 45 Years to any","Male or Female, age 45 years and over","Diagnosis of PSP-Richardson syndrome (RS) based on Movement Disorder Society (MDS) Criteria, including","Vertical supranuclear gaze palsy","Repeated unprovoked falls OR tendency to fall on the pull test within 3 years","Access to the internet and webcam for virtual visits","Presence of a caregiver"],"whoShouldSkip":["Recent history of significant, uncontrolled GI disease such as Gastroesophageal reflux disease, colorectal cancer","Significant metabolic or uncontrolled medical comorbidity","Regular use of typical anti-cholinergic drugs","Women of child-bearing potential, or who are pregnant and/or nursing","Suicidal ideation, as indicated by a response of 2 or 3 on question 9 of the Beck Depression Inventory","Any other condition or criterion that, in the opinion of the investigators, would preclude safe and meaningful participation in the study"],"whatHappens":"If you join, the listed intervention(s) are Tributyrin, or Placebo. The registry lists allocation as randomized. This research is studying a supplement called tributyrin in people with Progressive Supranuclear Palsy (PSP) to learn about its whether it is safe and how hard side effects are to live with as a potential treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 15 people at Ann Arbor. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.670Z"},{"nctId":"NCT07864558","title":"PrEcision Pacing in HFpEF: the PEP-HFpEF Trial","officialTitle":"PrEcision Pacing in HFpEF: the PEP-HFpEF Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Tufts Medical Center","sponsorClass":"OTHER","summary":"The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers. Participants will undergo sequential periods of standard and personalized pacing with serial physiologic assessments to evaluate the effects of myPACE on exercise capacity, cardiac function, biomarkers, quality of life, and clinical outcomes.","conditions":["Heart Failure and Preserved Ejection Fraction","Heart Failure New York Heart Association Class III","Heart Failure New York Heart Association (NYHA) Class II"],"keywords":["HFpEF","Heart Failure","pacemaker","personalized pacing","heart failure with preserved ejection fraction"],"interventions":[{"type":"DEVICE","name":"Individualized myPACE pacemaker programming"}],"enrollment":36,"startDate":"2026-11","completionDate":"2029-03","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction (LVEF) ≥50% with symptoms and signs consistent with heart failure as determined by the treating investigator.\n* New York Heart Association (NYHA) Class II or III symptoms despite stable, maximally tolerated guideline-directed medical therapy.\n* Pre-existing FDA-approved cardiac physiologic pacemaker (e.g., conduction system pacing or cardiac resynchronization therapy) implanted for a standard clinical indication and capable of individualized lower-rate programming.\n* Expected to require ongoing pacemaker therapy throughout the study period.\n* Clinically stable at enrollment, without recent major changes in heart failure status that, in the opinion of the investigator, would interfere with interpretation of study outcomes.\n* Able and willing to provide written informed consent.\n* Able and willing to comply with all study procedures, including pacemaker programming, cardiopulmonary exercise testing (CPET), echocardiography, blood pressure measurements, autonomic testing, blood collection, and follow-up visits.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* Left ventricular ejection fraction \\<50%.\n* Pregnancy, breastfeeding, or women of childbearing potential unwilling to use an acceptable method of contraception during study participation.\n* Inability or unwillingness to provide informed consent.\n* Inability to safely perform study procedures, including CPET or autonomic testing, in the opinion of the investigator.\n* Any medical condition or life expectancy that, in the opinion of the investigator, would make participation unsafe or would substantially interfere with completion of the study or interpretation of study results.\n* Enrollment in another interventional clinical trial that, in the opinion of the investigators, could interfere with this study or confound interpretation of the results.\n* Prisoners, wards of the state, or other individuals for whom participation would not be permissible under applicable regulations or institutional policy.","locations":[{"facility":"Tufts Medical Center","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Courtney Uek","phone":"617-636-4354","email":"courtney.uek@tuftsmedicine.org"}],"primaryOutcomes":["Peak Oxygen Consumption (Peak VO₂)"],"hasResults":false,"conditionSlugs":["heart-failure"],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Individualized myPACE pacemaker programming for Heart Failure and Preserved Ejection Fraction","inPlainEnglish":"The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers. Participants will undergo sequential periods of standard and personalized pacing with serial physiologic assessments to measure the effects of myPACE on exercise capacity, cardiac function, biomarkers, quality of life, and clinical outcomes.","whoItsFor":["Ages 18 Years to any","Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction (LVEF) ≥50% with symptoms and signs consistent with heart failure as determined by the treating investigator","New York Heart Association (NYHA) Class II or III symptoms despite stable, maximally tolerated guideline-directed medical therapy","Pre-existing FDA-approved cardiac physiologic pacemaker (e.g., conduction system pacing or cardiac resynchronization therapy) implanted for a standard clinical indication and capable of individualized lower-rate programming","Expected to require ongoing pacemaker therapy throughout the study period","Clinically stable at enrollment, without recent major changes in heart failure status that, in the opinion of the investigator, would interfere with interpretation of study outcomes"],"whoShouldSkip":["Left ventricular ejection fraction \\<50%","Pregnancy, breastfeeding, or women of childbearing potential unwilling to use an acceptable method of contraception during study participation","Inability to safely perform study procedures, including CPET or autonomic testing, in the opinion of the investigator","Any medical condition or life expectancy that, in the opinion of the investigator, would make participation unsafe or would substantially interfere with completion of the study or interpretation of study results","Enrollment in another treatment clinical trial that, in the opinion of the investigators, could interfere with this study or confound interpretation of the results","Prisoners, wards of the state, or other individuals for whom participation would not be permissible under applicable regulations or institutional policy"],"whatHappens":"If you join, the listed intervention(s) are Individualized myPACE pacemaker programming. The registry lists allocation as na. The PEP-HFpEF study is a prospective, single-center mechanistic study evaluating personalized heart rate pacing (myPACE) in patients with heart failure with preserved ejection fraction (HFpEF) and existing cardiac physiologic pacemakers.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 36 people at Boston. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.425Z"},{"nctId":"NCT07864883","title":"3D Modeling of Deep Endometriosis From Pelvic MRI","officialTitle":"Three-Dimensional Modeling of Deep Endometriosis From Pelvic MRI","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Strasbourg, France","sponsorClass":"OTHER","summary":"This retrospective monocentric study aims to assess the feasibility and clinical relevance of three-dimensional (3D) modeling of deep endometriosis lesions derived from pelvic MRI. The study evaluates whether 3D reconstruction improves surgical planning and multidisciplinary management.","conditions":["Deep Endometriosis"],"keywords":["Endometriosis","Magnetic Resonance Imaging","3D Modeling"],"interventions":[],"enrollment":60,"startDate":"2025-10-27","completionDate":"2026-12-27","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient aged 18 years or older\n* Confirmed diagnosis of deep endometriosis\n* Available and interpretable preoperative pelvic MRI\n* Surgical management performed at Strasbourg University Hospital between 01/01/2020 and 12/31/2022\n* No documented opposition to reuse of medical data\n\nExclusion Criteria:\n\n* Patient opposition to data reuse\n* Patient younger than 18 years\n* Incomplete medical records preventing MRI-3D-surgery comparison\n* Poor quality or non-interpretable MRI","locations":[{"facility":"Service de Gynécologie - CHU de Strasbourg - France","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Lecointre, MD, PhD","phone":"33 3 88 12 74 72","email":"lise.lecointre@chru-strasbourg.fr"}],"primaryOutcomes":["Impact of 3D modeling on surgical planning"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["strasbourg-france"],"enrichment":{"headline":"3D Modeling of Deep Endometriosis From Pelvic MRI","inPlainEnglish":"This retrospective monocentric study aims to assess the feasibility and clinical relevance of three-dimensional (3D) modeling of deep endometriosis lesions derived from pelvic MRI. The study evaluates whether 3D reconstruction improves surgical planning and multidisciplinary management.","whoItsFor":["Ages 18 Years to any","Women only","Patient aged 18 years or older","Confirmed diagnosis of deep endometriosis","Available and interpretable preoperative pelvic MRI","Surgical management performed at Strasbourg University Hospital between 01/01/2020 and 12/31/2022","No documented opposition to reuse of medical data"],"whoShouldSkip":["Patient opposition to data reuse","Patient younger than 18 years","Incomplete medical records preventing MRI-3D-surgery comparison","Poor quality or non-interpretable MRI"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 60 people at Strasbourg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.111Z"},{"nctId":"NCT07865052","title":"Psychological Prehabilitation for Complex Gastrointestinal Surgery","officialTitle":"PREPARE-GI: Psychological Resilience, Emotional Processing, and Adaptation Prehabilitation Program for Complex GI Surgery Patients","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Northwestern University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. The program is called PREPARE-GI. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery.\n\nMany people who need complex GI surgery have been through a lot. They may have had many surgeries, hospital stays, or emergency visits. These experiences can leave lasting stress, worry, and low mood. These feelings can make recovery from surgery harder.\n\nThe main questions this study aims to answer are:\n\n* Can researchers sign up enough participants, and will participants attend the program sessions and finish the surveys?\n* Does the program lower stress, worry (anxiety), and low mood (depression)?\n* Does the program lower pain and improve quality of life after surgery?\n* Does the program shorten hospital stays or lower return visits to the hospital or emergency room?\n\nResearchers will compare two groups. One group will take part in the PREPARE-GI program. The other group will get usual surgical care. Participants will be placed in a group by chance, like flipping a coin.\n\nAdults may be able to join if they:\n\nAre 18 or older Have complex GI surgery planned at Northwestern Memorial Hospital at least 8 weeks away Score high on a short survey about stress from past experiences Can complete the study in English\n\nAll participants will:\n\nAnswer survey questions about stress, worry, mood, body symptoms, pain, and quality of life. They will do this before surgery, then 1 month and 3 months after surgery. The surveys will take about 20 to 30 minutes to complete.\n\nRate their pain on a scale from 0 to 10 after surgery. Allow researchers to review their medical records for information about their surgery and recovery.\n\nParticipants in the program group will also meet one-on-one with a licensed psychologist for 8 sessions. Each session lasts about 1 hour and will take place either in person or by secure video from home.\n\nIn the sessions, participants will learn skills to manage stress, handle difficult feelings, and prepare for surgery and recovery.\n\nParticipants will be in the study for about 5 months. Participants in the program group will spend about 9 to 10 hours on the study. Participants in the usual care group will spend about 1 to 1.5 hours.\n\nThis is a small study with 20 participants. The results will help researchers plan a larger study in the future.","conditions":["Post-traumatic Stress Symptoms","Anxiety","Depression Disorder","Gastrointestinal Disease"],"keywords":["Psychological prehabilitation","Prehabilitation","Complex gastrointestinal surgery","Medical trauma","Perioperative care","Cognitive behavioral therapy","Unified Protocol","Pain catastrophizing","Postoperative recovery"],"interventions":[{"type":"BEHAVIORAL","name":"PREPARE-GI"}],"enrollment":20,"startDate":"2026-09-25","completionDate":"2027-07-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Scheduled for elective complex gastrointestinal surgery at Northwestern Memorial Hospital\n* Surgery scheduled at least 8 weeks after enrollment\n* PTSD Checklist for DSM-5 (PCL-5) score greater than 31 on screening\n* Able to understand and provide informed consent\n* Able to complete study procedures and questionnaires in English\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Unable to complete study procedures in English\n* Severe or unstable psychiatric illness that would interfere with safe participation or completion of the intervention, including: active psychosis, uncontrolled bipolar disorder, active suicidal ideation requiring urgent psychiatric intervention, cognitive impairment limiting decision-making capacity, unable to participate in follow-up assessments, currently pregnant, incarcerated","locations":[{"facility":"Northwestern Memorial Hospital","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maria Narvaez Pereyra, MD","phone":"561-271-5655","email":"maria.narvaezpereyra@northwestern.edu"}],"primaryOutcomes":["Enrollment rate","Intervention session completion","Assessment completion rate"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: PREPARE-GI for Post-traumatic Stress Symptoms","inPlainEnglish":"The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences. It is for adults having planned, complex surgery on the digestive system, also called gastrointestinal (GI) surgery.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Scheduled for elective complex gastrointestinal surgery at Northwestern Memorial Hospital","Surgery scheduled at least 8 weeks after enrollment","PTSD Checklist for DSM-5 (PCL-5) score greater than 31 on screening","Able to complete study procedures and questionnaires in English"],"whoShouldSkip":["Unable to complete study procedures in English"],"whatHappens":"If you join, the listed intervention(s) are PREPARE-GI. The registry lists allocation as randomized. The goal of this clinical trial is to learn if a psychological program before surgery can help adults who have lasting stress from past medical experiences.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Chicago. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.418Z"},{"nctId":"NCT07866066","title":"Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes","officialTitle":"A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Amgen","sponsorClass":"INDUSTRY","summary":"The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.","conditions":["Diabetes Mellitus, Type 2"],"keywords":["Add-on to Metformin","Maridebart Cafraglutide","Semaglutide","MariTide","A1C","Weight","Obesity","Overweight"],"interventions":[{"type":"DRUG","name":"Maridebart cafraglutide"},{"type":"DRUG","name":"Semaglutide"}],"enrollment":1300,"startDate":"2026-10-16","completionDate":"2028-09-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.\n* Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.\n* Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\\^2) at screening.\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.\n* Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.\n* Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.\n* One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.\n* History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.\n* Self-reported change in body weight \\> 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.\n* Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:\n\n  * liposuction and/or abdominoplasty that was performed \\> 1 year before screening.\n  * laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed \\> 1 year before screening.","locations":[{"facility":"Acclaim Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Bioclinical Research Alliance","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Indago Research and Health Center","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Center Of Florida","city":"Pompano Beach","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Conquest Research - Winter Park","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Virginia Nephrology Group","city":"Arlington","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastside Research Associates Health Research","city":"Redmond","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Dr T G Elliott Incorporated - BC Diabetes","city":"Vancouver","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amgen Call Center","phone":"866-572-6436","email":"medinfo@amgen.com"}],"primaryOutcomes":["Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["san-diego-california","miami-florida","miami-lakes-florida","pompano-beach-florida","winter-park-florida","arlington-virginia","redmond-washington","vancouver-canada"],"enrichment":{"headline":"Phase 3: testing Maridebart cafraglutide for Diabetes Mellitus, Type 2","inPlainEnglish":"The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.","whoItsFor":["Ages 18 Years to any","HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening","Body mass index (body-mass index (BMI)) ≥ 25 kilograms per meter squared (kg/m\\^2) at screening"],"whoShouldSkip":["Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes","Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema","Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy","One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery","History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms","Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:","liposuction and/or abdominoplasty that was performed \\> 1 year before screening"],"whatHappens":"If you join, the listed intervention(s) are Maridebart cafraglutide, or Semaglutide. The registry lists allocation as randomized. The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,300 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.526Z"},{"nctId":"NCT07866183","title":"Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study","officialTitle":"Trial of Innovative Fat-loss Focused Approaches in Patients With Class I Obesity: a Comparative Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Medical Research Center for Therapy and Preventive Medicine","sponsorClass":"OTHER_GOV","summary":"This single-center randomized comparative study is designed to compare the effectiveness of tirzepatide and transcutaneous low-frequency auricular vagus nerve stimulation in adults with class I obesity and without chronic non-communicable diseases. The study focuses on changes in body weight, anthropometric indices, epicardial and visceral adipose tissue, body composition, behavioral factors, skeletal muscle characteristics, and cardiac structure and function.\n\nThe study will include 120 participants. The active-treatment cohort will comprise 60 adults aged 25 to 50 years with class I obesity and low cardiovascular risk. These participants will be assigned to two active-treatment groups: 30 participants will receive tirzepatide (Tirzetta), and 30 participants will receive transcutaneous auricular vagus nerve stimulation using the HEALBE NEEM device. A control cohort of 60 participants will include 30 individuals with normal body weight and 30 individuals with class I obesity who will not receive either study intervention. Follow-up assessments will be conducted at Weeks 8, 16, and 24.\n\nThe primary efficacy outcomes are percentage reductions in body weight, waist-to-height ratio, epicardial adipose tissue thickness, and visceral adipose tissue. Secondary outcomes include changes in eating behavior, sleep, perceived stress, anxiety and depression, alcohol consumption, cigarette consumption, and myocardial deformation parameters.","conditions":["Class I Obesity"],"keywords":["tirzepatide; Tirzetta; class I obesity; transcutaneous auricular vagus nerve stimulation; weight loss; epicardial adipose tissue; visceral adipose tissue"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DEVICE","name":"Transcutaneous auricular vagus nerve stimulation"}],"enrollment":120,"startDate":"2026-06-29","completionDate":"2027-06","sex":"ALL","minAge":"25 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 25 to 50 years.\n* Low cardiovascular risk according to the SCORE scale (SCORE \\<1%).\n* Written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree.\n* For participants in the obesity cohorts: body mass index greater than or equal to 35 kg/m². Participants with normal body weight may be enrolled in the designated normal-weight control subgroup.\n* Expected technical difficulties with use of the stimulation device by the participant.\n* Any acute disease or chronic disease in the stage of exacerbation and/or decompensation.","locations":[{"facility":"National Medical Research Center for Therapy and Preventive Medicine","city":"Moscow","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elizaveta Rogozhkina, MD, PhD","phone":"+7 (937) 104-73-31","email":"lizarogozkina@gmail.com"}],"primaryOutcomes":["Percentage reduction in body weight","Percentage reduction in waist-to-height ratio","Percentage reduction in epicardial adipose tissue thickness","Percentage reduction in visceral adipose tissue"],"hasResults":false,"conditionSlugs":["als","obesity","depression"],"drugSlugs":["tirzepatide"],"locationSlugs":["moscow-russia"],"enrichment":{"headline":"Not a traditional drug phase: testing Tirzepatide for Class I Obesity","inPlainEnglish":"This single-center randomly assigned comparative study is designed to compare the effectiveness of tirzepatide and transcutaneous low-frequency auricular vagus nerve stimulation in adults with class I obesity and without chronic non-communicable diseases. The study focuses on changes in body weight, anthropometric indices, epicardial and visceral adipose tissue, body composition, behavioral factors, skeletal muscle characteristics, and cardiac structure and function.","whoItsFor":["Ages 25 Years to 50 Years","Age 25 to 50 years","Low cardiovascular risk according to the SCORE scale (SCORE \\<1%)"],"whoShouldSkip":["Cardiac rhythm disorders, including bradyarrhythmias and atrioventricular block of any degree","For participants in the obesity cohorts: body mass index greater than or equal to 35 kg/m². Participants with normal body weight may be enrolled in the designated normal-weight control subgroup","Expected technical difficulties with use of the stimulation device by the participant","Any acute disease or chronic disease in the stage of exacerbation and/or decompensation"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Transcutaneous auricular vagus nerve stimulation. The registry lists allocation as randomized. This single-center randomly assigned comparative study is designed to compare the effectiveness of tirzepatide and transcutaneous low-frequency auricular vagus nerve stimulation in adults with class I obesity and without chronic non-communicable diseases.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Moscow. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.034Z"},{"nctId":"NCT07866768","title":"CMN LIFU for Enhanced Amyloid Reduction (CLEART Study)","officialTitle":"Safety and Feasibility Study of ATTN201 Centromedian Nucleus of the Thalamus Focused Ultrasound Stimulation for Enhanced Glymphatic Clearance in Amyloid Positive Patients With Mild Cognitive Impairment","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain. Amyloid buildup is an early sign of Alzheimer's disease. The ATTN201 device sends low-intensity sound waves to a deep area of the brain that helps control sleep. The aim is to boost deep-sleep brain waves. These brain waves may help the brain clear away waste, including amyloid.\n\nThe main questions it aims to answer are:\n\n1. What, if any, issues do participants have when using the ATTN201 device?\n2. Can participants complete the full study schedule?\n\nResearchers will compare focused ultrasound to unfocused ultrasound. Unfocused ultrasound is a look-alike treatment. It feels and sounds the same but is not aimed at the brain target. The comparison will show if the focused treatment changes sleep brain waves, blood markers of Alzheimer's disease, or memory and thinking.\n\nParticipants will:\n\n* Visit the study site for memory and thinking tests, blood draws, a health check, and MRI scans of the brain\n* Record their sleep at home for at least 5 days with a sleep diary, a watch-like sensor, and a headband that measures brain waves\n* Be assigned by chance to focused or unfocused ultrasound\n* Take part in 10 nap sessions over 2 weeks while wearing the device, at the study site or at home\n* Return for a final visit to repeat the first tests, and may return for an optional visit 3 months later","conditions":["Alzheimer's Disease (AD)","Mild Cognitive Impairment (MCI)","Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease"],"keywords":["Alzheimer's Disease","Sleep","Low-Intensity Focused Ultrasound","Mild Cognitive Impairment"],"interventions":[{"type":"DEVICE","name":"ATTN201 Focused Ultrasound to the CMN"},{"type":"DEVICE","name":"ATTN201 Unfocused Ultrasound"}],"enrollment":28,"startDate":"2026-11","completionDate":"2028-01","sex":"ALL","minAge":"65 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 65+ years old, male or female\n2. Amyloid positivity as assessed by either PET, CSF, or plasma.\n3. Qualify for an MCI Diagnosis.\n4. Study partner available for informant measures.\n5. Willing and able to undergo a brain MRI.\n6. If currently on AD or sleep medications, must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating neurologist through the duration of the study.\n7. Be able and willing to wear an Attune device during treatments\n8. Able to sign informed consent in accordance with local regulations.\n9. Be able to speak, read, and understand the language of the trial staff and the informed consent form.\n10. Possess the ability to respond verbally to questions, follow instructions, and complete study assessments.\n11. Be able to adhere to the stimulation protocol and visit schedules.\n12. Be medically stable at baseline/randomization as assessed by medical history and non-significant clinical results of safety labs and vital signs examination.\n\nExclusion Criteria:\n\n1. Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65.\n2. Clinically significant depression, as defined by a score of \\>10 on the Geriatric Depression Scale\n3. Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15.\n4. Has other medical or psychiatric symptoms or conditions that, in the opinion of the investigator, will interfere with study activities or confound interpretation of study results.\n5. Is on medication which, in the opinion of the investigator, will confound study results.\n6. Has a history of deep brain stimulation or ablative surgery\n7. Has a history of substance abuse including alcohol use disorder in the past 6 months\n8. Has a history of traumatic brain injury\n9. Has any contraindications for completing a brain MRI scan.\n\n   a. The subject's head must fit within the head coil.\n10. Has an uncontrolled medical condition which may impact study results.\n11. Is or has an immediate family member of staff directly involved with this trial.","locations":[{"facility":"University of California San Francisco","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Andrew D Krystal, MD","phone":"415-514-0446","email":"clear@ucsf.edu"}],"primaryOutcomes":["Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events","Incidence of New Clinically Significant Findings on Post-Treatment Safety MRI","Study completion rate and adherence to scheduled study procedures"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Not a traditional drug phase: ATTN201 Focused Ultrasound to the CMN for Alzheimer's Disease (AD)","inPlainEnglish":"The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use. The study is for adults ages 65 and older who have mild cognitive impairment (MCI) and a buildup of a protein called amyloid in the brain.","whoItsFor":["Ages 65 Years to any","65+ years old, male or female","Amyloid positivity as assessed by either PET, CSF, or plasma","Qualify for an MCI Diagnosis","Study partner available for informant measures","Willing and able to undergo a brain MRI","If currently on AD or sleep medications, must be at the same stable dose(s) for at least 3 weeks prior to screening and throughout the course of the study, and must continue to be under the care of their treating neurologist through the duration of the study","Be able and willing to wear an Attune device during treatments"],"whoShouldSkip":["Early-onset Alzheimer's disease, as defined by a diagnosis occurring prior to age 65","Clinically significant depression, as defined by a score of \\>10 on the Geriatric Depression Scale","Moderate to severe untreated obstructive sleep apnea, as defined by an Apnea-Hypopnea Index (AHI) ≥ 15","Has other medical or psychiatric symptoms or conditions that, in the opinion of the investigator, will interfere with study activities or confound interpretation of study results","Is on medication which, in the opinion of the investigator, will confound study results","Has a history of deep brain stimulation or ablative surgery","Has a history of substance abuse including alcohol use disorder in the past 6 months"],"whatHappens":"If you join, the listed intervention(s) are ATTN201 Focused Ultrasound to the CMN, or ATTN201 Unfocused Ultrasound. The registry lists allocation as randomized. The goal of this clinical trial is to learn if a wearable ultrasound device, called ATTN201, is safe and easy to use.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 28 people at San Francisco. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.320Z"},{"nctId":"NCT07867002","title":"Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer","officialTitle":"Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"UNC Lineberger Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This is a pragmatic, non-inferiority randomized hybrid decentralized clinical trial. The goal of this study is to determine if one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab) is non-inferior to two years of maintenance therapy for patients with advanced/metastatic or recurrent endometrial cancer who have completed the standard course of cytotoxic chemotherapy plus anti-PD1 therapy (chemoimmunotherapy). Our hypothesis is that one year of maintenance therapy will be comparable, or statistically non-inferior, to two years of therapy. This question has clinical importance as there is not a clear optimal duration for maintenance immunotherapy in this setting, and checkpoint inhibitors are associated with their own unique toxicity profile (immune-related adverse events) and incremental costs to patients and the healthcare system at large. Patients who respond favorably to primary therapy and choose to enroll will be randomized (1:1) after completion of chemoimmunotherapy to one-year of maintenance anti-PD1 therapy (1-year arm) or to two-years of maintenance anti-PD1 therapy (2-year arm). The primary endpoint is progression-free survival (PFS) determined over the course of at least 3 years from randomization of patient follow up. Secondary endpoints are overall survival (OS) and incidence of immune-related adverse events (irAE). Finally, exploratory objectives include measuring differences in gut and vaginal microbial profiles and innate immune system (IIS) tumor profiles and correlation with clinical outcomes (PFS, OS).","conditions":["Endometrial Adenocarcinoma","Metastatic Endometrial Cancer","Endometrial Cancer","Recurrent Endometrial Cancer"],"keywords":["immunotherapy","maintenance immunotherapy"],"interventions":[{"type":"DRUG","name":"anti-PD1 agent therapy - 1 year"},{"type":"DRUG","name":"anti-PD1 agent therapy - 2 years"}],"enrollment":140,"startDate":"2026-09-09","completionDate":"2032-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nIn order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.\n\nWritten informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n\n* Age ≥ 18 years at the time of consent.\n* Advanced stage (FIGO Stage III or IV) or recurrent EC.\n* Histological or cytological evidence/confirmation of any EC subtype, including carcinosarcoma.\n* Subject has completed standard of care carboplatin/taxol/anti-PD1 therapy (pembrolizumab or dostarlimab) with the plan for maintenance anti-PD-1 therapy.\n\nExclusion Criteria:\n\n* Tumors with unknown mismatch repair protein status.\n* Receipt of additional anti-cancer agent(s) (e.g. bevacizumab, lenvatinib, progestins), other than cytotoxic chemotherapy received in combination with a PD-1 inhibitor at the beginning of the index treatment period (maintenance period).","locations":[{"facility":"UNC Health Cancer Care, A Service of UNC Hospitals","city":"Cary","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Lineberger Comprehensive Cancer Center","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Health Cancer Care, a service of UNC Hospitals (Garner)","city":"Garner","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Wesley Long Cone Health Cancer Center","city":"Greensboro","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Health Cancer Care, a service of UNC Hospitals (Raleigh)","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"UNC Health Cancer Care, a service of UNC Hospitals (Wakefield)","city":"Raleigh","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emmie Cole","phone":"919-984-0000","email":"emmie_cole@med.unc.edu"},{"name":"Erin Jennings","phone":"","email":"Erin_jennings@med.unc.edu"}],"primaryOutcomes":["Progression Free Survival"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["cary-north-carolina","chapel-hill-north-carolina","garner-north-carolina","greensboro-north-carolina","raleigh-north-carolina"],"enrichment":{"headline":"Phase 3: testing anti-PD1 agent therapy - 1 year for Endometrial Adenocarcinoma","inPlainEnglish":"This is a pragmatic, non-inferiority randomly assigned hybrid decentralized clinical trial. The goal of this study is to determine if one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab) is non-inferior to two years of maintenance therapy for patients with advanced/metastatic or recurrent endometrial cancer who have completed the standard course of cytotoxic chemotherapy plus anti-PD1 therapy (chemoimmunotherapy).","whoItsFor":["Ages 18 Years to any","In order to participate in this study a subject must meet ALL of the eligibility criteria outlined below","Age ≥ 18 years at the time of consent","Advanced stage (FIGO Stage III or IV) or recurrent EC","Histological or cytological evidence/confirmation of any EC subtype, including carcinosarcoma","Subject has completed standard of care carboplatin/taxol/anti-PD1 therapy (pembrolizumab or dostarlimab) with the plan for maintenance anti-PD-1 therapy"],"whoShouldSkip":["Tumors with unknown mismatch repair protein status","Receipt of additional anti-cancer agent(s) (e.g. bevacizumab, lenvatinib, progestins), other than cytotoxic chemotherapy received in combination with a PD-1 inhibitor at the beginning of the index treatment period (maintenance period)"],"whatHappens":"If you join, the listed intervention(s) are anti-PD1 agent therapy - 1 year, or anti-PD1 agent therapy - 2 years. The registry lists allocation as randomized. This is a pragmatic, non-inferiority randomly assigned hybrid decentralized clinical trial.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 140 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.694Z"},{"nctId":"NCT07867080","title":"A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).","officialTitle":"A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Efficacy, Safety, and Durability of a Single Intravitreal Injection of 4D-150 Versus Aflibercept in Adults With Diabetic Macular Edema (4SIGHT)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"4D Molecular Therapeutics","sponsorClass":"INDUSTRY","summary":"A Phase 3, Randomized, Double-Masked, Active-Controlled Trial to Evaluate the Safety, Efficacy, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)","conditions":["Diabetic Macular Edema (DME)"],"keywords":["Diabetic Macular Edema","DME","Retinal gene therapy","Intravitreal gene therapy","Genetic Medicine","Ocular Gene Therapy","Eye Diseases","Intravitreal Injections","Aflibercept"],"interventions":[{"type":"BIOLOGICAL","name":"4D-150 IVT (3x10^10 vg)"},{"type":"BIOLOGICAL","name":"EYELEA ® (aflibercept) Injection 2 mg (0.05mL)"}],"enrollment":514,"startDate":"2026-09-18","completionDate":"2029-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"5.2 Inclusion Criteria\n\nIndividuals eligible to participate in the trial must meet the following inclusion criteria:\n\nGeneral Inclusion Criteria\n\n1. Signed informed consent before any protocol-specified assessment is performed\n2. Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment\n3. ≥18 years of age at time of signing informed consent\n4. Documented diagnosis of diabetes mellitus (Type 1 or Type 2)\n5. WOCBP must agree to use highly effective contraception from the time of informed consent, through duration of trial participation\n6. Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular Inclusion Criteria\n7. Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye\n8. Study eye amenable to IVT injection identified\n9. Presence of intraretinal fluid and/or subretinal fluid secondary to DME\n10. Decreased visual acuity attributable primarily to DME, as determined by the Investigator\n11. Demonstrated clinical response to aflibercept and functional stability in the study eye\n\nExclusion Criteria: Individuals who meet any of the following exclusion criteria will not be eligible to participate:\n\nOcular Condition\n\n1. Macular conditions other than DME\n2. History or presence of moderate Proliferative Diabetic Retinopathy or worse\n3. History of retinal detachment in the study eye\n4. History or presence of active inflammation or infection in either eye\n5. History or presence of low Intraocular Pressure\n6. Uncontrolled glaucoma or intraocular hypertension\n\n   Ocular Treatments/Interventions:\n7. Any prior concomitant treatment for DME\n8. History of prior significant ocular surgery or treatment\n9. Any prior investigational drug, agent, device, or gene therapy","locations":[{"facility":"Research Network Arizona","city":"Scottsdale","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Retina Partners","city":"Encino","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants of Orange County","city":"Fullerton","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retina Associates of Southern California","city":"Huntington Beach","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retinal Consultants Medical Group Inc.","city":"Sacramento","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retina Consultants San Diego","city":"San Diego","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Retina Institute of New England","city":"San Mateo","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bay Area Retina Associates - 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Kyorin University Hospital - Mitaka","city":"Mitaka-shi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Miyazaki Hospital","city":"Miyazaki","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nagoya University Hospital","city":"Nagoya","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Toho University Sakura Medical Center","city":"Sakura-shi","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital","city":"Tokyo","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"National Hospital Organization Tokyo Medical Center","city":"Tokyo","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Emanuelli Research & Development Center, LLC (ERD)","city":"Arecibo","state":"","country":"Puerto Rico","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"4DMT Patient Advocacy","phone":"(888) 748-8881","email":"clinicaltrials@4DMT.com"},{"name":"4SIGHT Medical Monitoring Distribution List","phone":"","email":"4D150C005_MM@4dmt.com"}],"primaryOutcomes":["Mean change from baseline in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity letter score at Week 52"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["scottsdale-arizona","encino-california","fullerton-california","huntington-beach-california","sacramento-california","san-diego-california","san-mateo-california","walnut-creek-california","aurora-colorado","colorado-springs-colorado","durango-colorado","greenwich-connecticut","waterford-connecticut","fort-lauderdale-florida","orlando-florida","pensacola-florida","plantation-florida","tampa-florida","elmhurst-illinois","lemont-illinois","oak-park-illinois","springfield-illinois","carmel-indiana","chevy-chase-maryland","hagerstown-maryland","madison-mississippi","southaven-mississippi","st-louis-missouri","reno-nevada","bloomfield-new-jersey","edison-new-jersey","new-york-new-york","westbury-new-york","asheville-north-carolina","cary-north-carolina","wake-forest-north-carolina","middleburg-heights-ohio","edmund-oklahoma","portland-oregon","bethlehem-pennsylvania","philadelphia-pennsylvania","bluffton-south-carolina","charleston-south-carolina","rapid-city-south-dakota","nashville-tennessee","abilene-texas","austin-texas","dallas-texas","houston-texas","katy-texas","the-woodlands-texas","tyler-texas","fairfax-virginia","lynchburg-virginia","wausau-wisconsin","beijing-china","changchun-china","changsha-china","haerbin-china","hangzhou-china","jinan-china","lanzhou-china","nanchang-china","shanghai-china","taiyuan-china","taizhou-china","tianjin-china","weifang-china","wuhan-china","zhengzhou-china","mito-japan","amagasaki-shi-japan","fukuoka-japan","fukushima-japan","hachioji-shi-japan","kagoshima-japan","kita-gun-japan","kobe-japan","kyoto-japan","mitaka-shi-japan","miyazaki-japan","nagoya-japan","sakura-shi-japan","tokyo-japan","arecibo-puerto-rico"],"enrichment":{"headline":"Phase 3: testing 4D-150 IVT (3x10^10 vg) for Diabetic Macular Edema (DME)","inPlainEnglish":"A Phase 3, randomly assigned, Double-Masked, Active-Controlled Trial to measure the Safety, how well it works, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)","whoItsFor":["Ages 18 Years to any","Individuals eligible to participate in the trial must meet the following who can join:","General who can join","Ability and willingness to comply with the protocol-specified procedures (including IVT injection) and visits, in the Investigator's judgment","Documented diagnosis of diabetes mellitus (Type 1 or Type 2)","Agree to use a barrier method (e.g., condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period Ocular who can join","Macular thickening secondary to DME involving the center of the fovea (confirmed by the Reading Center) in the study eye","Study eye amenable to IVT injection identified"],"whoShouldSkip":["Individuals who meet any of the following"],"whatHappens":"If you join, the listed intervention(s) are 4D-150 IVT (3x10^10 vg), or EYELEA ® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. A Phase 3, randomly assigned, Double-Masked, Active-Controlled Trial to measure the Safety, how well it works, and Durability of a Single Intravitreal Injection of 4D-150 versus Aflibercept in Adults with Diabetic Macular Edema (4SIGHT)","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 514 people at 94 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:28.059Z"},{"nctId":"NCT07868354","title":"A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication","officialTitle":"An Open-label, Multiple-arm Study to Assess Tolerability in Participants With Overweight or Obesity, With or Without Type 2 Diabetes, When Switching From Tirzepatide to Zenagamtide","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get tirzepatide and zenagamtide.","conditions":["Overweight","Obesity","Type 2 Diabetes"],"keywords":[],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Zenagamtide"}],"enrollment":60,"startDate":"2026-10-08","completionDate":"2028-09-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n* Age 18 years or older at the time of signing the informed consent.\n* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n* Participants on a stable treatment dose of tirzepatide for at least 4 weeks.\n\nOnly for participants with T2D:\n\n* Diagnosed with type 2 diabetes before screening.\n* Treatment with 0-2 marketed oral glucose-lowering medications (metformin or sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily doses) for at least 90 days before screening.\n\nExclusion Criteria:\n\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* History of reduction in dose of tirzepatide, due to intolerability, without successful reescalation.\n* Presence of any clinically relevant condition that causes symptoms which are similar to the gastrointestinal adverse events (GI AEs) linked to glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment, and which could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints.\n* Ongoing use of medications causing clinically relevant gastrointestinal symptoms that could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints, as judged by the investigator.\n* Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are:\n* use of tirzepatide as described in inclusion criterion 5\n* glucose-lowering medication mentioned in inclusion criterion 7 (only for participants with T2D)\n* stable use (initiated minimum 30 days before screening) of statins, blood pressure lowering medicine, beta blockers\n* highly effective contraceptives\n* occasional use of paracetamol, ibuprofen and acetylsalicylic acid.\n\nOnly for participants without T2D:\n\n\\- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.\n\nOnly for participants with T2D:\n\n* Glycated haemoglobin (HbA1c) more than or equal to (≥) 10.5 percent (%) \\[91 millimoles per mole (mmol/mol)\\] at screening.\n* Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.\n* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions, except conditions associated with diabetes mellitus.","locations":[{"facility":"PAREXEL Glendale/LA EPCU","city":"Glendale","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"PAREXEL Intl - EPCU-Baltimore","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["Number of treatment emergent adverse events (TEAE)"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["glendale-california","baltimore-maryland"],"enrichment":{"headline":"Phase 1: testing Tirzepatide for Overweight","inPlainEnglish":"The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get tirzepatide and zenagamtide.","whoItsFor":["Ages 18 Years to any","Male or female (sex assigned at birth, inclusive of all gender identities)","Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator","Participants on a stable treatment dose of tirzepatide for at least 4 weeks","Only for participants with T2D:","Diagnosed with type 2 diabetes before screening"],"whoShouldSkip":["Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method","History of reduction in dose of tirzepatide, due to intolerability, without successful reescalation","Ongoing use of medications causing clinically relevant gastrointestinal symptoms that could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints, as judged by the investigator","Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are:","use of tirzepatide as described in inclusion criterion 5","glucose-lowering medication mentioned in inclusion criterion 7 (only for participants with T2D)","stable use (initiated minimum 30 days before screening) of statins, blood pressure lowering medicine, beta blockers"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Zenagamtide. The registry lists allocation as na. The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.029Z"},{"nctId":"NCT07868666","title":"Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes","officialTitle":"Clinical Decision Support for SGLT2i After AKI in Type 2 Diabetes Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Minnesota","sponsorClass":"OTHER","summary":"This pilot study will evaluate the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury.\n\nParticipating M Health Fairview primary care clinics will be randomized to either receive the clinical decision support intervention or continue usual care. In intervention clinics, providers or clinic pharmacists will receive a message before a scheduled encounter with an eligible patient. The message is intended to support clinical decision-making about SGLT2 inhibitor use, but prescribing decisions will remain with the patient's usual clinical care team.\n\nThe study will assess feasibility outcomes, including identification of eligible patients, delivery of clinical decision support (CDS) messages, provider/pharmacist receipt of CDS messages, SGLT2i consideration, SGLT2i prescribing, and availability of follow-up kidney function data in the electronic health record.","conditions":["Type 2 Diabetes Mellitus","Acute Kidney Injury","Chronic Kidney Diseases"],"keywords":["SGLT2 inhibitor","Acute kidney injury","Type 2 diabetes"],"interventions":[{"type":"OTHER","name":"Clinical Decision Support Message"}],"enrollment":250,"startDate":"2026-11-02","completionDate":"2032-10-31","sex":"ALL","minAge":"30 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria for Providers and Pharmacists:\n\n* Assigned to work in a primary care specialty as a medical provider or assigned to work as a clinic pharmacist\n* Assigned to work in one of the participating study clinics\n\nInclusion Criteria for Patients:\n\n* Scheduled to be seen in a participating clinic with a physician or advanced practice provider in a primary care specialty or a clinic pharmacist\n* Medical history of acute kidney injury during a hospitalization with discharge within 1 year before the scheduled appointment\n* Medical history of type 2 diabetes mellitus (by billing code)\n* Age 30 to 75 years at the date of study enrollment\n* Available eGFR from labs more than 3 business days before the scheduled appointment and after AKI onset that is at least 30 mL/min/1.73 m²\n* Either a serum creatinine lab measured after discharge from the hospitalization including the AKI, or the last serum creatinine lab during the hospitalization with AKI is less than 0.3 mg/dL above the patient's baseline serum creatinine concentration\n\nExclusion Criteria for Providers and Pharmacists:\n\n* None\n\nExclusion Criteria for Patients:\n\n* Opted out of research use of AHC/M Health Fairview data shelter data\n* History of kidney transplantation as a recipient(by billing code)\n* Pregnancy documented in AHC/M Health Fairview data shelter data (by billing code)\n* SGLT2i allergy in the EHR allergy list\n* Medical history of diabetic ketoacidosis, dementia, hospice care, or oncology care (by billing code and/or encounter)\n* Medical history in the prior 1 year of indwelling Foley urinary catheter, cystitis, pyelonephritis, prostatitis, or urinary tract infection (by billing code)\n* Serum creatinine rise of at least 0.3 mg/dL between the two most recent serum creatinine measurements\n* Children\n* Prisoners","locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Daniel P. Murphy","phone":"612-624-9444","email":"murph670@umn.edu"}],"primaryOutcomes":["Feasibility of Identifying Eligible Patients","Feasibility of Clinical Decision Support Message Delivery","SGLT2i Consideration After Clinical Decision Support","Follow-up Kidney Function Data Availability","SGLT2i Prescribing After Qualifying Encounter","Feasibility of Adaptive Second Randomization"],"hasResults":false,"conditionSlugs":["type-2-diabetes","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["minneapolis-minnesota"],"enrichment":{"headline":"Not a traditional drug phase: Clinical Decision Support Message for Type 2 Diabetes Mellitus","inPlainEnglish":"This pilot study will measure the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury. Participating M Health Fairview primary care clinics will be randomly assigned to either receive the clinical decision support intervention or continue usual care.","whoItsFor":["Ages 30 Years to 75 Years","for Providers and Pharmacists:","Assigned to work in a primary care specialty as a medical provider or assigned to work as a clinic pharmacist","Assigned to work in one of the participating study clinics","who can join for Patients:","Scheduled to be seen in a participating clinic with a physician or advanced practice provider in a primary care specialty or a clinic pharmacist","Medical history of acute kidney injury during a hospitalization with discharge within 1 year before the scheduled appointment","Medical history of type 2 diabetes mellitus (by billing code)"],"whoShouldSkip":["for Providers and Pharmacists:"],"whatHappens":"If you join, the listed intervention(s) are Clinical Decision Support Message. The registry lists allocation as randomized. This pilot study will measure the feasibility of using a clinical decision support(CDS) message to support consideration of SGLT2 inhibitor prescribing in patients with type 2 diabetes who recently had acute kidney injury.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 250 people at Minneapolis. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.503Z"},{"nctId":"NCT07869043","title":"A Study to Learn About the Study Medicine Called Tilrekimig ( PF-07275315) in People With Severe Asthma","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF TILREKIMIG IN ADULT AND ADOLESCENT PARTICIPANTS WITH SEVERE ASTHMA","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.\n\nThe study is seeking participants who:\n\n* Have a history of severe asthma for at least 12 months\n* Have had at least 2 asthma attacks (also known as exacerbations) within the last 12 months All participants will be given shots of study medicine or a placebo at the study clinic. Tilrekimig or the placebo will be given about every 4 weeks during the study.\n\nThe study will compare the experiences of people receiving tilrekimig to those people who receive the placebo. This will help determine if tilrekimig is safe and effective.","conditions":["Asthma"],"keywords":[],"interventions":[{"type":"DRUG","name":"tilrekimig"},{"type":"OTHER","name":"Placebo"}],"enrollment":1100,"startDate":"2026-09-30","completionDate":"2029-06-07","sex":"ALL","minAge":"12 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria\n\nMust meet the following asthma criteria:\n\n1. History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines.\n2. Must have experienced at least 2 asthma exacerbations requiring treatment with systemic steroids (oral or parenteral) for 3 consecutive days or more; an emergency room or urgent care visit (\\<24 hours) that is due to asthma and requires use of systemic corticosteroids as noted above; or an in-patient hospitalization (an admission to an in-patient hospital or evaluation and treatment in a healthcare facility for ≥24 hours) due to asthma with within 12 months of the screening visit.\n3. Positive bronchodilator responsiveness of FEV1 or FVC \\>10% of the participant's predicted value at 15 - 30 minutes (or as consistent with local treatment practices) after inhaling 400 µg of salbutamol/albuterol (or equivalent SABA) at least once for spirometry conducted during screening period.\n\n   Other Inclusion Criteria:\n4. Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening).\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions:\n\n1. Evidence of lung disease(s) other than asthma, either clinical evidence, spirometry, or imaging (Chest X-ray, CT, MRI) within 12 months of the screening visit, as per local standard of care, including but not limited to, chronic obstructive pulmonary disease, other emphysematous lung disease such as alpha-1 antitrypsin disease, cystic fibrosis, emphysema, pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, sarcoidosis, pulmonary embolism.\n2. Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study.\n\n   Prior/Concomitant Therapy:\n3. Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit.\n4. Prior or concurrent treatment with either approved or experimental biologic treatment (such as inhibitors of IL-4Ralpha, TSLP, OX40/OX40L, IL-13, IL-33 / ST2) or targeted synthetic drugs for the treatment of asthma or other type 2 inflammatory diseases, including but not limited to: AD, EoE, CRS.\n5. Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig).\n6. Bronchial thermoplasty within the previous 24 months.\n\n   Prior/Concurrent Clinical Study Experience:\n7. Administration of an investigational drug product within 30 days or 5 half lives preceding the screening visit (whichever is longer). Previous participation in other tilrekimig studies or participation in studies of other investigational products (drug or vaccine) at any time during this study.","locations":[{"facility":"Asthma and Allergy Center of Chicago","city":"River Forest","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hannibal Regional Healthcare System, Inc.","city":"Hannibal","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Urban Health Plan","city":"The Bronx","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of Oklahoma Health Sciences Center","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Allergy and Clinical Immunology Associates","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orion Clinical Research","city":"Austin","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southwest Medical Center (Building I) aka Southwest Family Medicine Associates","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"A & A Research Consultants, LLC","city":"Edinburg","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Western Sky Medical Research","city":"El Paso","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pulmonary and Sleep Center of the Valley","city":"McAllen","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research","city":"Tomball","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Solace Clinical Research","city":"Bayamón","state":"","country":"Puerto Rico","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Annualized asthma exacerbation rate over 52 weeks"],"hasResults":false,"conditionSlugs":["als","asthma"],"drugSlugs":[],"locationSlugs":["river-forest-illinois","hannibal-missouri","the-bronx-new-york","oklahoma-city-oklahoma","pittsburgh-pennsylvania","austin-texas","dallas-texas","edinburg-texas","el-paso-texas","mcallen-texas","tomball-texas","bayam-n-puerto-rico"],"enrichment":{"headline":"Phase 3: testing tilrekimig for Asthma","inPlainEnglish":"The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma. Asthma is a condition that makes it challenging to breathe, which negatively impacts the quality of life of people who are affected.","whoItsFor":["Ages 12 Years to 80 Years","Must meet the following asthma criteria:","History of persistent, severe asthma for at least 12 months prior to screening as defined by recognized international and / or local guidelines","Other who can join:","Maintenance treatment of a medium-to-high dose ICS plus an additional controller (eg, LABA) consistent with current GINA and / or local guidelines for at least 12 months (and on a stable dose for 3 months prior to screening)"],"whoShouldSkip":["Participants are excluded from the study if any of the following criteria apply:","Medical Conditions:","Any psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years that may increase the risk of study participation or, in the investigator's judgement, make the participant inappropriate for the study","Prior/Concomitant Therapy:","Use of any prohibited concomitant medication(s) or unwillingness or inability to use a required concomitant medication(s). Treatment with any dose level of systemic (oral, intraarticular, or injectable) corticosteroids within 28 days of the screening visit","Prior (within 12 weeks prior to Screening Visit 1) or planned concomitant treatment with immunoglobulin supplementation (eg, IV Ig or SC Ig)","Bronchial thermoplasty within the previous 24 months"],"whatHappens":"If you join, the listed intervention(s) are tilrekimig, or Placebo. The registry lists allocation as randomized. The purpose of this clinical study is to learn about the safety and effects of the study medicine (called tilrekimig) for the potential treatment of severe asthma.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,100 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.345Z"},{"nctId":"NCT07869836","title":"BL-M07D1 (Trastuzumab Brengitecan T-bren) vs Standard of Care Platinum-based Chemotherapy (PBC) for HER2-expressing Metastatic Urothelial Cancer After Progression on Anti-PD-(L)1-based Therapy","officialTitle":"A Phase 3 Open-Label, Randomized Controlled Trial of T-bren (BL M07D1) vs. Platinum-based Chemotherapy in Patients With HER2 Expressing Metastatic Urothelial Cancer With Disease Progression on or After Anti-PD-(L)1-based Therapy","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"SystImmune Inc.","sponsorClass":"INDUSTRY","summary":"The objective of the study is to evaluate the efficacy and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.","conditions":["Urothelial Cancer","Metastatic Urothelial Cancer","Bladder Cancer","Bladder Cancer (BC)","Bladder (Urothelial, Transitional Cell) Cancer","Bladder (Urothelial, Transitional Cell) Cancer Metastatic or Unresectable","Bladder Ca","Bladder Cancer Recurrent","Bladder Cancer Stage IV","Urothelial Carcinoma Bladder","Urothelial Carcinoma Recurrent","Urothelial Carcinoma of the Urinary Bladder"],"keywords":["Bladder","Urothelial","ADC","T-bren","HER2","Metastatic","Second line","Third line","Targeted Therapy","Antibody drug conjugate"],"interventions":[{"type":"DRUG","name":"T-Bren, Dose level 1"},{"type":"DRUG","name":"T-bren, Dose level 2"},{"type":"DRUG","name":"Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin)"}],"enrollment":520,"startDate":"2026-11","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Histologically or cytologically documented metastatic or surgically unresectable transitional cell carcinoma (TCC) of the urothelium involving the renal pelvis, ureter, bladder, or urethra. Minor histologic variants (ie, \\<50% overall) are acceptable, provided that TCC is the dominant histology.\n* Disease progression or recurrence during or following anti-PD-(L)1-based therapy.\n* Fresh biopsy or archival tumor samples.\n* Documented HER2 expression by central laboratory testing.\n* Eligible to receive carboplatin or cisplatin in combination with gemcitabine.\n* At least 1 measurable lesion based on RECIST v1.1.\n* An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1.\n* Adequate organ function.\n* Adequate coagulation parameters.\n\nExclusion Criteria:\n\n* Prior topoisomerase inhibitor-based ADC therapy.\n* Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis.\n* Bladder cancers with small cell histology.\n* Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years.\n* Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization.\n* Active autoimmune diseases and inflammatory diseases.\n* History of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.\n* Advanced/clinically significant lung disease (eg, poorly controlled chronic obstructive pulmonary disease or asthma, restrictive lung disease, or pulmonary hypertension) within 6 months prior to randomization.\n* Known human immunodeficiency virus infection.\n* Active hepatitis B virus (HBV) infection.\n* Active hepatitis C virus (HCV) infection.\n* Active or latent tuberculosis.\n* Other protocol-specified inclusion/ exclusion criteria apply","locations":[{"facility":"Central Georgia Cancer Center","city":"Macon","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christine LaRock","phone":"425-453-6841","email":"Christine.LaRock@systimmune.com"}],"primaryOutcomes":["Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":["bladder-cancer"],"drugSlugs":[],"locationSlugs":["macon-georgia"],"enrichment":{"headline":"Phase 3: testing T-Bren, Dose level 1 for Urothelial Cancer","inPlainEnglish":"The objective of the study is to measure the how well it works and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.","whoItsFor":["Ages 18 Years to any","Disease progression or recurrence during or following anti-PD-(L)1-based therapy","Fresh biopsy or archival tumor samples","Documented HER2 expression by central laboratory testing","Eligible to receive carboplatin or cisplatin in combination with gemcitabine","At least 1 measurable lesion based on RECIST v1.1","An Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1","Adequate organ function"],"whoShouldSkip":["Prior topoisomerase inhibitor-based ADC therapy","Primary tumors in the central nervous system (CNS), active or untreated CNS metastases, or carcinomatous meningitis","Bladder cancers with small cell histology","Other prior or concurrent malignancies except for certain localized cancers or low-grade prostate cancer (if approved by sponsor), or other malignancy treated with curative intent with a disease-free interval of at least 3 years","Prior history of clinically significant bleeding, or perforation of the gastrointestinal tract within 6 months of randomization","Active autoimmune diseases and inflammatory diseases","History of noninfectious interstitial lung disease (ILD)/pneumonitis that required treatment with steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening"],"whatHappens":"If you join, the listed intervention(s) are T-Bren, Dose level 1, T-bren, Dose level 2, or Gemcitabine + Platinum Based Chemotherapy (Cisplatin or Carboplatin). The registry lists allocation as randomized. The objective of the study is to measure the how well it works and safety of T-bren in participants with HER2 expressing metastatic UC with progression on or after anti-PD-(L)1-based therapy.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 520 people at Macon. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.286Z"},{"nctId":"NCT07870044","title":"Investigating Techniques to Enhance the Sense of Embodiment in Immersive Virtual Reality","officialTitle":"Studio Dell'Embodiment In Ambienti Di Realtà Virtuale Immersiva","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"IRCCS Eugenio Medea","sponsorClass":"OTHER","summary":"Embodiment is an important aspect of virtual reality because it affects how natural and engaging the experience feels and can influence performance and learning in VR-based applications, including rehabilitation. In VR, embodiment refers to the extent to which a person feels that a virtual body (avatar) is their own and under their control. It is typically described as having three components: sense of agency (feeling that one is causing the avatar's actions), body ownership (feeling that the avatar's body is one's own), and self-location (feeling located where the avatar is). While many VR systems aim to increase embodiment, there is limited evidence on which specific techniques are most effective-especially in people with acquired neurological injuries, in whom central nervous system damage may alter body perception and multisensory integration.\n\nThis study will compare several VR techniques that may enhance embodiment, including synchronized visual and tactile stimulation, heart-rate-based visual biofeedback, increased possibilities to actively control the avatar, and familiarity with the performed action. Participants will include healthy volunteers and individuals with acquired neurological injuries (spinal cord injury or stroke). Across three study days, participants will complete multiple short VR conditions while wearing physiological sensors, and after each VR condition, participants will complete questionnaires about their VR experience. The goal is to identify which VR techniques most effectively increase embodiment and whether embodiment-related responses differ between healthy participants and clinical groups.","conditions":["Spinal Cord Injury","Stroke","Healthy"],"keywords":["embodiment","virtual reality","Sense of agency","body ownership","Self-location","virtual avatar"],"interventions":[{"type":"BEHAVIORAL","name":"Immersive Virtual Reality Embodiment Manipulations"}],"enrollment":90,"startDate":"2026-02-02","completionDate":"2028-08","sex":"ALL","minAge":"12 Years","maxAge":"50 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 12 to 50 years\n* Typically developing participants (healthy volunteers) OR participants with spinal cord injury OR participants with history of stroke\n* Score ≥ 7 on the \"Vocabulary\" subtest of WISC (for minors) or WAIS (for adults)\n\nExclusion Criteria:\n\n* History of epilepsy or epileptic seizures\n* Poor head control\n* Visual acuity not correctable with glasses","locations":[{"facility":"IRCCS Eugenio Medea","city":"Bosisio Parini","state":"Lecco","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Emilia Biffi, PhD Eng","phone":"+39 031 877862","email":"emilia.biffi@lanostrafamiglia.it"},{"name":"Giorgia Malerba, PhD Candidate","phone":"+39 031 877645","email":"giorgia.malerba@lanostrafamiglia.it"}],"primaryOutcomes":["Virtual Embodiment Questionnaire (VEQ) Subscale Scores (Ownership, Agency, Perceived Change in Body Representation)"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["bosisio-parini-italy"],"enrichment":{"headline":"Not a traditional drug phase: Immersive Virtual Reality Embodiment Manipulations for Spinal Cord Injury","inPlainEnglish":"Embodiment is an important aspect of virtual reality because it affects how natural and engaging the experience feels and can influence performance and learning in VR-based applications, including rehabilitation. In VR, embodiment refers to the extent to which a person feels that a virtual body (avatar) is their own and under their control.","whoItsFor":["Ages 12 Years to 50 Years","Typically developing participants (healthy volunteers) OR participants with spinal cord injury OR participants with history of stroke","Score ≥ 7 on the \"Vocabulary\" subtest of WISC (for minors) or WAIS (for adults)"],"whoShouldSkip":["History of epilepsy or epileptic seizures","Visual acuity not correctable with glasses"],"whatHappens":"If you join, the listed intervention(s) are Immersive Virtual Reality Embodiment Manipulations. The registry lists allocation as na. Embodiment is an important aspect of virtual reality because it affects how natural and engaging the experience feels and can influence performance and learning in VR-based applications, including rehabilitation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 90 people at Bosisio Parini. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.206Z"},{"nctId":"NCT07870538","title":"A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum","officialTitle":"A Neuropsychobiological Approach to Optimize Patient Selection for GLP-1-based Pharmacotherapy for Weight Management Across the Binge Eating Spectrum","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Universitaire Ziekenhuizen KU Leuven","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to investigate how GLP-1 receptor analogs, such as semaglutide (Wegovy®), influence processes that determine eating behavior, binge eating, and weight regulation via the gut-brain axis. The main question it aims to answer is: to identify for whom semaglutide works best.\n\nParticipants will:\n\n* undergo a semaglutide treatment for 6 months\n* visit the clinic for 2-4 study checkup and tests\n* wear a smartwatch and complete questionnaires on their smartphone","conditions":["Obesity & Overweight"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide 3,2 mg/ml"}],"enrollment":96,"startDate":"2026-08-26","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures\n2. At least 18 years of age and under 65 years of age at the time of signing the informed consent form (ICF)\n3. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner.\n4. BMI ≥ 30 kg/m² or BMI ≥ 27 kg/m² with at least one weight-related comorbidity\n\nExclusion Criteria:\n\n1. Any form of diabetes mellitus (T1- or T2DM), defined as current hemoglobin A1c (HbA1c) \\> 6.5% or the use of antihyperglycemic drugs (metformin is permitted if prescribed for an indication other than T2DM and at a stable dose for at least 3 months days prior to screening)\n2. Use of incretin-based drugs, including GLP-1RAs (including dual agonists) and dipeptidyl peptidase-4 (DPP-4) inhibitors or amylin analogues within 3 months prior to screening\n3. Contraindications for semaglutide: history of pancreatitis, medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)\n4. Chronic kidney disease 3b or worse, defined as estimated Glomerular Filtration Rate (eGFR) \\< 45 ml/min/1.73m²\n5. Previous bariatric surgery\n6. Disorders known to affect DA signaling significantly, including movement disorders such as Parkinson's disease, prolactinoma, paraganglioma, pheochromocytoma\n7. Active use of medication affecting DA signaling, including antiparkinson medications, attention deficit hyperactivity disorder (ADHD) medications, antipsychotics, naltrexone-bupropion for weight management or antidepressants; use of serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), or trazodone is permitted if participants are on a stable dose for at least three months. Incidental use of antiemetics or sedative hypnotics is allowed but not within 48 hours prior to a study visit\n8. Current or recent (within the past 6 months) clinically significant alcohol or drug misuse (excluding nicotine) that, in the investigator's judgment, may compromise participant safety or the integrity of study data.\n9. Active severe neuropsychiatric disorders, including dementia, psychotic disorder, bipolar disorder and severe depression\n10. Acute suicidality or history of suicide attempt within 5 years prior to screening\n11. Any condition or major illness which, in the investigator's opinion, may jeopardise participant safety or compliance with the protocol\n12. Unable to understand the risks, realistic benefits and compliance requirements of each program\n13. Unwillingness to be informed about incidental findings that may be important for the participant's health\n14. Recent participation (\\< 30 days) or simultaneous participation in an interventional Trial with an investigational medicinal product (IMP) or device\n15. If applicable: Female who is pregnant, breast-feeding or intends to become pregnant in the following 6 months or is of childbearing potential and not using an adequate, highly effective contraceptive\n16. For PET scanning (subset n=64): exposure to a significant amount (\\> 1mSv) of ionizing radiation in other research studies within the last 12 months\n17. For MRI scanning: any condition that would interfere with MRI scanning (e.g., cochlear implant, metal fragments in the eyes, cardiac pacemaker, neural stimulator and metallic body inclusion or other metallic implants in the body which may interfere with MRI scanning)\n18. Claustrophobia or too much uneasiness in limited spaces (to tolerate confinement during scanning procedures)\n19. Severe back problems, interfering with lying in supine position in the scanner without movement for long durations","locations":[{"facility":"UZ/KU Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Roman Vangoitsenhoven, Prof. Dr.","phone":"+3216193235","email":"roman.vangoitsenhoven@uzleuven.be"},{"name":"Nathalie Weltens, PhD","phone":"+32 16 37 74 86","email":"nathalie.weltens@kuleuven.be"}],"primaryOutcomes":["Change in Body Mass Index (BMI) after semaglutide treatment","Change in Binge Eating Scale (BES) score after semaglutide treatment"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["leuven-belgium"],"enrichment":{"headline":"Phase 4: testing Semaglutide 3,2 mg/ml for Obesity & Overweight","inPlainEnglish":"The goal of this clinical trial is to investigate how GLP-1 receptor analogs, such as semaglutide (Wegovy®), influence processes that determine eating behavior, binge eating, and weight regulation via the gut-brain axis. The main question it aims to answer is: to identify for whom semaglutide works best.","whoItsFor":["Ages 18 Years to 65 Years","body-mass index (BMI) ≥ 30 kg/m² or body-mass index (BMI) ≥ 27 kg/m² with at least one weight-related comorbidity"],"whoShouldSkip":["Any form of diabetes mellitus (T1- or T2DM), defined as current hemoglobin A1c (HbA1c) \\> 6.5% or the use of antihyperglycemic drugs (metformin is permitted if prescribed for an indication other than T2DM and at a stable dose for at least 3 months days prior to screening)","Use of incretin-based drugs, including GLP-1RAs (including dual agonists) and dipeptidyl peptidase-4 (DPP-4) inhibitors or amylin analogues within 3 months prior to screening","Contraindications for semaglutide: history of pancreatitis, medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)","Chronic kidney disease 3b or worse, defined as estimated Glomerular Filtration Rate (eGFR) \\< 45 ml/min/1.73m²","Previous bariatric surgery","Disorders known to affect DA signaling significantly, including movement disorders such as Parkinson's disease, prolactinoma, paraganglioma, pheochromocytoma","Current or recent (within the past 6 months) clinically significant alcohol or drug misuse (excluding nicotine) that, in the investigator's judgment, may compromise participant safety or the integrity of study data"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide 3,2 mg/ml. The registry lists allocation as na. The goal of this clinical trial is to investigate how GLP-1 receptor analogs, such as semaglutide (Wegovy®), influence processes that determine eating behavior, binge eating, and weight regulation via the gut-brain axis.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 96 people at Leuven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.735Z"},{"nctId":"NCT07870915","title":"Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome","officialTitle":"Investigation of the Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Saglik Bilimleri Universitesi","sponsorClass":"OTHER","summary":"This cross-sectional, observational, controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), postural characteristics will be evaluated using the Corbin Posture Analysis, and stool type in the IBS-C group will be assessed using the Bristol Stool Scale.","conditions":["Constipation","Irritable Bowel Disease"],"keywords":["irritable bowel disease","posture","interoception"],"interventions":[],"enrollment":128,"startDate":"2026-10-01","completionDate":"2027-03-31","sex":"ALL","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18-45 years.\n* For the IBS-C group, having a clinical diagnosis of constipation-predominant irritable bowel syndrome.\n* For the control group, having no history of gastrointestinal disease.\n* Voluntarily agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Having a neurological, rheumatological, or serious orthopedic disease.\n* Having a history of surgery that may affect posture.\n* Pregnancy.\n* Being unable to complete the assessments due to cognitive or communication impairment.","locations":[{"facility":"İstanbul Topkapı University","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gamze Koyutürk, Asst Prof","phone":"+905065798671","email":"gamzealtinkaynak@gmail.com"},{"name":"Mehmet Burak Uyaroğlu, Asst Prof","phone":"","email":""}],"primaryOutcomes":["Interoceptive Awareness","Postural Characteristics"],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome","inPlainEnglish":"This cross-sectional, watch-and-measure (no experimental treatment required), controlled comparative study aims to investigate the relationship between interoception and postural control in individuals with constipation-predominant irritable bowel syndrome (IBS-C) and to compare the findings with those of healthy individuals. Interoception will be assessed using the Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2), postural characteristics will be evaluated using the Corbin Posture Analysis, and stool type in the IBS-C group will be assessed using the Bristol Stool Scale.","whoItsFor":["Ages 18 Years to 45 Years","For the IBS-C group, having a clinical diagnosis of constipation-predominant irritable bowel syndrome","For the control group, having no history of gastrointestinal disease","Voluntarily agreeing to participate in the study"],"whoShouldSkip":["Having a neurological, rheumatological, or serious orthopedic disease","Having a history of surgery that may affect posture","Being unable to complete the assessments due to cognitive or communication impairment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 128 people at Istanbul. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.433Z"},{"nctId":"NCT07871006","title":"Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1","officialTitle":"Ofatumumab in Treatment-Refractory¬ Narcolepsy Type 1","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Xijing Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab. The main questions it aims to answer are:\n\n* Does ofatumumab could improve persistent or chronic NT1 who had insufficient responses to multiple prior treatment regimens or declined conventional medications?\n* The safety -What medical problems do participants have when taking ofatumumab? Researchers will compare Epworth Sleepiness Scale and cataplexy frequency before and after ofatumumab treatment to see if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.\n\nParticipants will:\n\n* Take one dose of ofatumumab and monitoring one day for the injection-related reactions\n* Visit the clinic at one month after ofatumumab for checkups and tests\n* Keep a diary of their symptoms","conditions":["Narcolepsy Type 1 (NT1)"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"ofatumumab 20mg"}],"enrollment":20,"startDate":"2025-10-01","completionDate":"2027-06-30","sex":"ALL","minAge":"10 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* patients who were clinically diagnosed with narcolepsy type 1\n* aged10-60 years, male or female.\n* A lumbar puncture was performed to evaluate the CSF orexin-A level.\n* HLA typing was performed.\n* Patients who had previously failed (no response or no maintenance) guideline- specified first-line therapy for narcolepsy and had previously received at least one guideline-specified second-line treatment for narcolepsy type 1and failed (no response or no maintenance). Or patients who refused to drug treatment.\n* Subjects with no significant laboratory abnormalities during screening.\n* Patients and their legal guardians must comprehensively understand and be able to adhere to the study protocol requirements and willingly sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab.\n* Patients were excluded if they had a previous immune disease, or patients diagnosed with various secondary and hereditary auto-immune disorders, contraindications to lumbar puncture, conditions or medication with known substantial impact on the immune system, with impact on the result of lumbar puncture.\n* Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases.\n* Patients who are positive for HIV antibodies or syphilis antibodies.\n* Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc.","locations":[{"facility":"Xijing Hospital","city":"Xi'an","state":"Shaanxi","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yonghong Liu, MD;PhD","phone":"029-84771058","email":"xjwxl2012@163.com"}],"primaryOutcomes":["the Epworth Sleepiness Scale （ESS ：0-24）","cataplexy rate"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":["ofatumumab"],"locationSlugs":["xian-china"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ofatumumab 20mg for Narcolepsy Type 1 (NT1)","inPlainEnglish":"The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1. It will also learn about the safety of ofatumumab.","whoItsFor":["Ages 10 Years to 60 Years","patients who were clinically diagnosed with narcolepsy type 1","aged10-60 years, male or female","A lumbar puncture was performed to measure the CSF orexin-A level","HLA typing was performed","Subjects with no significant laboratory abnormalities during screening"],"whoShouldSkip":["Patients allergic to ofatumumab, or had failed to respond to previous treatment with ofatumumab","Patients with uncontrollable primary diseases of important organs, such as liver failure, heart failure, renal failure and other diseases","Patients who are positive for HIV antibodies or syphilis antibodies","Patients accompanied by uncontrollable active infection, including hepatitis B, hepatitis C, cytomegalovirus, EB virus, etc"],"whatHappens":"If you join, the listed intervention(s) are ofatumumab 20mg. The registry lists allocation as na. The goal of this clinical trial is to learn if ofatumumab works to treat drug-Refractory¬ Narcolepsy Type 1.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at Xi'an. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:25.268Z"},{"nctId":"NCT07871071","title":"Brain-Computer Interface Communication Device for People With ALS","officialTitle":"Within-Subject Longitudinal Evaluation of the Cognixion ONE Brain-Computer Interface Speech Generating Device in Individuals With ALS","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Cognixion","sponsorClass":"INDUSTRY","summary":"This study compares a wearable brain-computer interface (BCI) communication device with the eye-tracking communication devices that people with ALS already use.\n\nAs ALS progresses, speech is lost and many people come to rely on an eye-tracking speech generating device. Eye-tracking performance can decline as oculomotor control is affected, and some people reach a point where it no longer works reliably for them. The Cognixion ONE device adds a brain-computer interface input, which does not depend on eye movement, alongside an AI-assisted communication application.\n\nThirty adults with ALS who currently use a Tobii Dynavox or Smartbox eye-tracking device will take part. Each participant uses three communication options at home over a 12-week period: their own eye-tracking device, the Cognixion ONE device with a head-worn augmented-reality display, and the Cognixion ONE device with a screen-based display. For some sessions the option is assigned; for others the participant chooses.\n\nThe main measure is how much time participants voluntarily choose to spend using each option. That choice is treated as the clearest signal of which option genuinely works better for them. The study also measures communication speed and accuracy, usability, workload, quality of life, and caregiver burden.\n\nThe Cognixion ONE device is an investigational research device. It is not approved or cleared by the U.S. Food and Drug Administration for any medical use.","conditions":["Amyotrophic Lateral Sclerosis"],"keywords":["brain-computer interface","BCI","augmentative and alternative communication","AAC","speech generating device","augmented reality","electroencephalography","SSVEP","eye tracking","assistive technology"],"interventions":[{"type":"DEVICE","name":"Cognixion ONE AR-BCI configuration"},{"type":"DEVICE","name":"Cognixion ONE screen-based BCI configuration"},{"type":"DEVICE","name":"Existing eye-gaze speech generating device"}],"enrollment":30,"startDate":"2026-11-15","completionDate":"2028-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of ALS established by a neurologist, meeting either the Gold Coast Criteria (preferred) or the revised El Escorial criteria (definite, probable, probable laboratory-supported, or possible ALS), documented by the referring or treating neurologist\n* ALSFRS-R Speech subscale score of 3 or lower (impaired but functional speech) through 0 (anarthric)\n* Documented use of a Tobii Dynavox or Smartbox eye-gaze speech generating device as primary or secondary communication method for at least 30 days prior to screening. Candidates who meet all other criteria but lack a prescribed eye-gaze device may be provided a loaner device, capped at 25 percent of the enrolled cohort\n* Age 18 years or older\n* A designated, trainable caregiver able to be present for structured study sessions and to complete a 2-hour onboarding and a Month-3 refresher\n* Volitional eye opening sustained independently for at least 30 minutes, and sufficient visual function to perceive the augmented-reality display stimuli\n* A reliable communication method other than the study device for affirmative assent, at minimum a yes/no channel via residual vocalization, head movement, blink, or brow raise\n* Sufficient English comprehension to engage with the study protocol and the AI conversational interface\n\nExclusion Criteria:\n\n* Active hospice enrollment without documented capacity to participate in research activities\n* Cognitive or behavioral impairment of a degree that would preclude successful participation in study procedures, as judged by the treating neurologist, a study neurologist, or the study speech-language pathologist\n* History of photosensitive epilepsy or active seizure disorder\n* Sensitivity to flashing lights\n* Severe uncorrected visual impairment that precludes use of an augmented-reality display\n* Vision disorders restricting the visual field, such as glaucoma with significant field loss, diplopia, or nystagmus\n* History of vertigo or other vestibular disorders that would be aggravated by augmented-reality display use\n* Claustrophobia related to head-mounted display use, after attempted accommodation\n* Scalp condition prone to irritation, inflammation, injury, or infectious process that precludes safe placement of EEG electrodes\n* Severe oculomotor impairment that precludes establishment of an initial eye-gaze calibration on the participant's existing eye-gaze device\n* Concurrent enrollment in another investigational communication-device or brain-computer interface trial\n* Severe hearing impairment or deafness that would prevent participation in conversational tasks","locations":[{"facility":"Cognixion Corporation","city":"Santa Barbara","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cognixion Study Team","phone":"8332646496","email":"cognih001@cognixion.com"}],"primaryOutcomes":["Voluntary daily use time per input modality"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["santa-barbara-california"],"enrichment":{"headline":"Not a traditional drug phase: Cognixion ONE AR-BCI configuration for Amyotrophic Lateral Sclerosis","inPlainEnglish":"This study compares a wearable brain-computer interface (BCI) communication device with the eye-tracking communication devices that people with ALS already use. As ALS progresses, speech is lost and many people come to rely on an eye-tracking speech generating device.","whoItsFor":["Ages 18 Years to any","Diagnosis of ALS established by a neurologist, meeting either the Gold Coast Criteria (preferred) or the revised El Escorial criteria (definite, probable, probable laboratory-supported, or possible ALS), documented by the referring or treating neurologist","ALSFRS-R Speech subscale score of 3 or lower (impaired but functional speech) through 0 (anarthric)","Age 18 years or older","A designated, trainable caregiver able to be present for structured study sessions and to complete a 2-hour onboarding and a Month-3 refresher","Volitional eye opening sustained independently for at least 30 minutes, and sufficient visual function to perceive the augmented-reality display stimuli","A reliable communication method other than the study device for affirmative assent, at minimum a yes/no channel via residual vocalization, head movement, blink, or brow raise","Sufficient English comprehension to engage with the study protocol and the AI conversational interface"],"whoShouldSkip":["Active hospice enrollment without documented capacity to participate in research activities","Cognitive or behavioral impairment of a degree that would preclude successful participation in study procedures, as judged by the treating neurologist, a study neurologist, or the study speech-language pathologist","History of photosensitive epilepsy or active seizure disorder","Sensitivity to flashing lights","Severe uncorrected visual impairment that precludes use of an augmented-reality display","Vision disorders restricting the visual field, such as glaucoma with significant field loss, diplopia, or nystagmus","History of vertigo or other vestibular disorders that would be aggravated by augmented-reality display use"],"whatHappens":"If you join, the listed intervention(s) are Cognixion ONE AR-BCI configuration, Cognixion ONE screen-based BCI configuration, or Existing eye-gaze speech generating device. The registry lists allocation as randomized. This study compares a wearable brain-computer interface (BCI) communication device with the eye-tracking communication devices that people with ALS already use.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Santa Barbara. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.607Z"},{"nctId":"NCT07871097","title":"Acute Treatment of Vestibular Migraine by Rimegepant","officialTitle":"Efficacy of Rimegepant in the Treatment of Acute Vestibular Migraine -- Multicenter, Prospective, Cross-design, Randomized, Placebo-controlled Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"QUADRUPLE","sponsor":"Wensheng Qu","sponsorClass":"OTHER","summary":"To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.","conditions":["Vestibular Migraine"],"keywords":["remigepant"],"interventions":[{"type":"DRUG","name":"First dose rimegepant, second dose placebo"},{"type":"DRUG","name":"First dose placebo, second dose rimegepant"}],"enrollment":80,"startDate":"2025-12-01","completionDate":"2027-11-30","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18-60 years, male or female.\n2. Diagnosis of vestibular migraine according to the Bárány Society criteria.\n3. ≥4 episodes of characteristic vestibular symptoms in the past year, each of moderate to severe intensity and lasting \\>2 hours (without intervention).\n4. Signed informed consent obtained from the participant.\n\nExclusion Criteria:\n\n1. Presence of other disorders causing acute vestibular symptoms (e.g., Ménière's disease, otitis media).\n2. Coexisting non-vertiginous dizziness (e.g., dizziness due to panic disorder), unless the patient can clearly distinguish these episodes from vestibular-migraine attacks.\n3. Severe hepatic dysfunction (ALT and/or AST \\>3× upper limit of normal) or renal impairment (creatinine clearance \\<30 mL/min).\n4. Severe cardiovascular or cerebrovascular disease.\n5. Alcohol abuse or substance abuse.\n6. Known pregnancy or lactation, or a positive pregnancy test prior to randomization.\n7. Contraindication or hypersensitivity to any medications used in the study.\n8. Initiation or dose adjustment of any preventive migraine therapy within 3 months prior to study drug administration.\n9. Use of any other anti-vertigo or analgesic medication within 6 hours before study drug administration.\n10. Participation in another interventional clinical study that could affect outcome assessment.\n11. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study or poses significant risk.","locations":[{"facility":"Tongji Hospital","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wensheng Qu","phone":"18971622660","email":"qws0309@163.com"}],"primaryOutcomes":["Vertigo symptom relief rate"],"hasResults":false,"conditionSlugs":["migraine"],"drugSlugs":[],"locationSlugs":["wuhan-china"],"enrichment":{"headline":"Phase 4: testing First dose rimegepant, second dose placebo for Vestibular Migraine","inPlainEnglish":"To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.","whoItsFor":["Ages 18 Years to 60 Years","Age 18-60 years, male or female","Diagnosis of vestibular migraine according to the Bárány Society criteria","≥4 episodes of characteristic vestibular symptoms in the past year, each of moderate to severe intensity and lasting \\>2 hours (without intervention)"],"whoShouldSkip":["Presence of other disorders causing acute vestibular symptoms (e.g., Ménière's disease, otitis media)","Coexisting non-vertiginous dizziness (e.g., dizziness due to panic disorder), unless the patient can clearly distinguish these episodes from vestibular-migraine attacks","Severe hepatic dysfunction (ALT and/or AST \\>3× upper limit of normal) or renal impairment (creatinine clearance \\<30 mL/min)","Severe cardiovascular or cerebrovascular disease","Alcohol abuse or substance abuse","Known pregnancy or lactation, or a positive pregnancy test prior to randomization","Contraindication or hypersensitivity to any medications used in the study"],"whatHappens":"If you join, the listed intervention(s) are First dose rimegepant, second dose placebo, or First dose placebo, second dose rimegepant. The registry lists allocation as randomized. To evaluate whether rimegepant improves acute vestibular symptoms and accompanying discomforts in patients with vestibular migraine.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 80 people at Wuhan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.307Z"},{"nctId":"NCT07871149","title":"PMOS in OSA Pilot Study","officialTitle":"Metabolic Changes in PMOS Patients With Obstructive Sleep Apnea (OSA) Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"University of Chicago","sponsorClass":"OTHER","summary":"The goal of this study is to obtain pilot data investigating the effects of sleep apnea on mitochondrial function and cellular metabolism in Polyendocrine Metabolic Ovarian Syndrome (PMOS) patients.","conditions":["PCOS","PCOS (Polycystic Ovary Syndrome)","OSA","OSA - Obstructive Sleep Apnea"],"keywords":["PCOS","OSA","PMOS"],"interventions":[{"type":"DEVICE","name":"Continuous Positive Airway Pressure (CPAP)"}],"enrollment":10,"startDate":"2026-10","completionDate":"2027-10","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Women 18-40 years old\n* PMOS diagnosis\n* Sleep Apnea (AHI\\>5) diagnosed by home sleep test (WatchPAT One)\n* BMI\\< 50.0\n\nExclusion Criteria:\n\n* Regular adherent CPAP use per clinical guidelines\n* Any history of bleeding disorders\n* Current use of anti-coagulant medication\n* Hemoglobin \\<11.6 g/dL\n* Currently pregnant, pregnant within the last year, or gave birth within the last year\n* Any underlying disease likely to limit life span and/or increase risk of interventions including cardiovascular disease (e.g. unstable angina, heart failure requiring hospitalization in the past 6 months, significant heart block or arrhythmias, NYHA Class\\>2), pulmonary disease with dependence on oxygen or daily use of bronchodilators, cancer requiring treatment in the past 5 years unless the prognosis is considered good, active or chronic infection, thyroid disease and other endocrine disorders (e.g. Cushing syndrome, acromegaly), hepatitis or other chronic gastrointestinal disease (pancreatitis, inflammatory bowel disease), renal disease, significant anemia, recent surgery or significant abdominal surgery, major psychiatric or any eating disorder, acute coronary syndrome or stroke in the past 6 months","locations":[{"facility":"University of Chicago","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bonnie Olivia Hughes","phone":"773-834-7809","email":"bhughes8@bsd.uchicago.edu"}],"primaryOutcomes":["Complex I and II/Electron Transport System Capacity"],"hasResults":false,"conditionSlugs":["pcos","sleep-apnea"],"drugSlugs":[],"locationSlugs":["chicago-illinois"],"enrichment":{"headline":"Not a traditional drug phase: Continuous Positive Airway Pressure (CPAP) for PCOS","inPlainEnglish":"The goal of this study is to obtain pilot data investigating the effects of sleep apnea on mitochondrial function and cellular metabolism in Polyendocrine Metabolic Ovarian Syndrome (PMOS) patients.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Women 18-40 years old","Sleep Apnea (AHI\\>5) diagnosed by home sleep test (WatchPAT One)"],"whoShouldSkip":["Regular adherent CPAP use per clinical guidelines","Any history of bleeding disorders","Current use of anti-coagulant medication","Hemoglobin \\<11.6 g/dL","Currently pregnant, pregnant within the last year, or gave birth within the last year"],"whatHappens":"If you join, the listed intervention(s) are Continuous Positive Airway Pressure (CPAP). The registry lists allocation as randomized. The goal of this study is to obtain pilot data investigating the effects of sleep apnea on mitochondrial function and cellular metabolism in Polyendocrine Metabolic Ovarian Syndrome (PMOS) patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Chicago. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.788Z"},{"nctId":"NCT07871409","title":"Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight","officialTitle":"A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Amgen","sponsorClass":"INDUSTRY","summary":"The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.","conditions":["Obesity","Overweight"],"keywords":["AMG 133"],"interventions":[{"type":"DRUG","name":"Maridebart cafraglutide"},{"type":"DEVICE","name":"Autoinjector"}],"enrollment":230,"startDate":"2026-10-15","completionDate":"2027-06-16","sex":"ALL","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m\\^2), or BMI ≥ 27 to \\< 30 kg/m\\^2 with one of the following:\n\n  * hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg\n  * dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.\n  * history of obstructive sleep apnea\n  * history of cardiovascular disease\n  * history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \\[MASLD\\] or metabolic dysfunction-associated steatohepatitis \\[MASH\\])\n* At least 1 unsuccessful attempt at weight loss by diet and exercise.\n* Contraception for females.\n* Willingness to follow trial procedures for the duration of the trial.\n\nExclusion Criteria:\n\n* Obesity induced by other endocrinologic disorders.\n* Change in body weight \\> 5 kg within last 90 days.\n* Previous or planned surgical, endoscopic, or device-based treatment for obesity.\n* History of malignancy within the past 5 years.\n* Type 1 or Type 2 diabetes mellitus.\n* History of chronic pancreatitis or history of acute pancreatitis within last 180 days.\n* Family or personal history of medullary thyroid cancer.\n* Previous participation in a Maridebart Cafraglutide trial.","locations":[{"facility":"Apex Clinical Research","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Southern Clinical Research","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Institute of South Florida","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Neuroscience Solutions LLC","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Florida Institute for Clinical Research","city":"Orlando","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Charter Research - The Villages","city":"The Villages","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Nsc Research","city":"Johns Creek","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research","city":"Woodstock","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Solaris Clinical Research","city":"Meridian","state":"Idaho","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alliance For Multispecialty Research - Oak Brook","city":"Oak Brook","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Flourish Research","city":"Bowie","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Rochester Clinical Research","city":"Rochester","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research","city":"Morehead City","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centricity Research Dublin","city":"Columbus","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research - Oklahoma","city":"Chickasha","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tribe Clinical Research LLC Dba Mountain View Clinical Research","city":"Greenville","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Health Research- Texas Native Health","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cedar Health Research, LLC","city":"Dallas","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Soma Clinical Trials, LLC","city":"Denison","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Epic Medical Research - Red Oak","city":"DeSoto","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Biopharma Informatic, LLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Physicians Network LLC","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Texas Institute of Cardiology","city":"McKinney","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"North Hills Medical Research","city":"North Richland Hills","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Latin Clinical Trial Center","city":"San Juan","state":"","country":"Puerto Rico","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Amgen Call Center","phone":"866-572-6436","email":"medinfo@amgen.com"}],"primaryOutcomes":["Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration","Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["san-diego-california","miami-florida","orlando-florida","the-villages-florida","johns-creek-georgia","woodstock-georgia","meridian-idaho","oak-brook-illinois","bowie-maryland","rochester-new-york","morehead-city-north-carolina","columbus-ohio","chickasha-oklahoma","greenville-south-carolina","dallas-texas","denison-texas","desoto-texas","houston-texas","mckinney-texas","north-richland-hills-texas","san-juan-puerto-rico"],"enrichment":{"headline":"Phase 3: testing Maridebart cafraglutide for Obesity","inPlainEnglish":"The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.","whoItsFor":["Ages 18 Years to 99 Years","Body mass index (body-mass index (BMI)) ≥ 30 kilograms per meter square (kg/m\\^2), or body-mass index (BMI) ≥ 27 to \\< 30 kg/m\\^2 with one of the following:","hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg","dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol","history of obstructive sleep apnea","history of cardiovascular disease","history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease \\[MASLD\\] or metabolic dysfunction-associated steatohepatitis \\[MASH\\])","At least 1 unsuccessful attempt at weight loss by diet and exercise"],"whoShouldSkip":["Obesity induced by other endocrinologic disorders","Change in body weight \\> 5 kg within last 90 days","Previous or planned surgical, endoscopic, or device-based treatment for obesity","History of malignancy within the past 5 years","Type 1 or Type 2 diabetes mellitus","History of chronic pancreatitis or history of acute pancreatitis within last 180 days","Family or personal history of medullary thyroid cancer"],"whatHappens":"If you join, the listed intervention(s) are Maridebart cafraglutide, or Autoinjector. The registry lists allocation as na. The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 230 people at 25 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.521Z"},{"nctId":"NCT07871435","title":"GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) (JET-201)","officialTitle":"A Phase 1b/2, Open-label, Multi-center Study to Evaluate the Anti-cancer Activity, Safety and Tolerability of GI-102 (CD80-IgG4 Fc-IL2v3) in Combination With Pasritamig [T-CELL-Redirecting Agent Targeting Human Kallikrein 2 (KLK2)] in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Progressed on Previous Novel Hormonal Therapy (NHT) (JET-201)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"GI Innovation, Inc.","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).","conditions":["Metastatic Castration-resistant Prostate Cancer (mCRPC)"],"keywords":["Metastatic castration-resistant prostate cancer","Immunotherapy","GI-102","CD80-IgG4 Fc-IL2 variant","Interleukin-2","Immunocytokine","bispecific protein","pasritamig","T cell engager"],"interventions":[{"type":"DRUG","name":"GI-102"},{"type":"DRUG","name":"Pasritamig"}],"enrollment":107,"startDate":"2026-10-12","completionDate":"2029-03-31","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements).\n* ECOG performance status of 0 to 1.\n* Histologically confirmed advanced prostate adenocarcinoma with measurable or evaluable disease. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, primary small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma (or pathologic evidence of conversion to) is disallowed.\n* Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression following at least one line of novel androgen receptor-targeted therapy.\n* PSA ≥2 ng/mL at screening.\n* No more than 2 prior taxane regimens and no prior cytotoxic chemotherapy other than taxane therapy.\n* Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels.\n* Adequate organ and marrow function and adequate cardiovascular function.\n* Adequate recovery from prior anticancer therapy-related adverse events.\n* Willingness and ability to comply with study procedures and protocol-specified contraception requirements.\n\nKey Exclusion Criteria:\n\n* Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression.\n* Significant uncontrolled cardiovascular, pulmonary, hepatic, autoimmune, infectious, or other systemic disease.\n* Active or recent clinically significant infection, including active tuberculosis, hepatitis B, or hepatitis C.\n* Active pneumonitis or interstitial lung disease (ILD), or history of clinically significant pneumonitis/ILD.\n* Recent treatment with investigational products, prohibited immunomodulating agents, radiotherapy, major surgery, or other protocol-defined prohibited therapies.\n* Prior treatment with CD3-directed therapies, including KLK2-CD3 bispecific antibodies or other CD3-targeting T-cell engagers.\n* Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results.","locations":[{"facility":"Columbia University Medical Center","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Catholic University of Korea Seoul ST.MARY'S Hospital","city":"Seoul","state":"Banpo-daero","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Korea University Anam Hospital","city":"Seoul","state":"Seongbuk-gu","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ewha Womans University Mokdong Hospital","city":"Seoul","state":"Yangcheon-gu","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Yonsei University Health System, Severance Hospital","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null},{"facility":"Asan Medical Center","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kwang-Soo Shin","phone":"+82-2-404-2003","email":"Clinical-102-P201@gi-innovation.com"}],"primaryOutcomes":["Incidence and nature of DLTs (Safety run-in phase)","Incidence, nature, and severity of AEs graded according to CTCAE v6.0 (Safety run-in phase)","PSA response rate (≥ 50% decline from baseline) per PCWG3 (Expansion phase)"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["new-york-new-york","seoul-south-korea"],"enrichment":{"headline":"Phase 1 / Phase 2: testing GI-102 for Metastatic Castration-resistant Prostate Cancer (mCRPC)","inPlainEnglish":"The purpose of this clinical trial is to measure the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).","whoItsFor":["Ages 18 Years to any","Men only","Male participants aged ≥18 years (or ≥19 years according to local regulatory requirements)","how well you can do daily activities (ECOG score) of 0 to 1","Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression following at least one line of novel androgen receptor-targeted therapy","PSA ≥2 ng/mL at screening","No more than 2 prior taxane regimens and no prior cytotoxic chemotherapy other than taxane therapy","Prior orchiectomy or ongoing androgen deprivation therapy with castrate testosterone levels","Adequate organ and marrow function and adequate cardiovascular function"],"whoShouldSkip":["Active or prior CNS metastases, carcinomatous meningitis, or clinically unstable spinal cord compression","Significant uncontrolled cardiovascular, pulmonary, hepatic, autoimmune, infectious, or other systemic disease","Active or recent clinically significant infection, including active tuberculosis, hepatitis B, or hepatitis C","Active pneumonitis or interstitial lung disease (ILD), or history of clinically significant pneumonitis/ILD","Recent treatment with investigational products, prohibited immunomodulating agents, radiotherapy, major surgery, or other protocol-defined prohibited therapies","Prior treatment with CD3-directed therapies, including KLK2-CD3 bispecific antibodies or other CD3-targeting T-cell engagers","Known hypersensitivity to GI-102, pasritamig, or their excipients, or any other condition that may interfere with study participation or interpretation of results"],"whatHappens":"If you join, the listed intervention(s) are GI-102, or Pasritamig. The registry lists allocation as randomized. The purpose of this clinical trial is to measure the safety, tolerability, and preliminary anti-cancer activity of GI-102 in combination with pasritamig in adult men with metastatic castration-resistant prostate cancer (mCRPC) whose cancer has progressed after previous treatment with a novel hormonal therapy (NHT).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 107 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.310Z"},{"nctId":"NCT07872384","title":"Supplemental Mobility","officialTitle":"Improving Functional Recovery in Skilled Nursing Facilities Through Supplemental Mobility","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of Colorado, Denver","sponsorClass":"OTHER","summary":"This pilot study will evaluate the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization. STAMP will be administered by a mobility aide who will support patients in increasing physical activity through walking and transfers outside of structured rehabilitation. Participants will either receive high-intensity rehabilitation (HIR) or usual care rehabilitation, combined with STAMP. The two main aims are: 1) determine the feasibility, acceptability, and safety of STAMP, and 2) evaluate the feasibility and variability of patient physical function outcome measures. The study will provide preliminary data on program delivery and safety to inform the design of a larger trial aimed at identifying the most effective strategies to optimize functional recovery in SNFs.","conditions":["Aging","Functional Recovery","Skilled Nursing Facility","Medically Complex","Deconditioning"],"keywords":["Rehabilitation","Older Adults","Physical Therapy","Occupational Therapy","i-STRONGER","High-Intensity Rehabilitation","Post-Acute Care","Physical Function","Safe Transfers and Mobility Program","Feasibility","Implementation Science"],"interventions":[{"type":"OTHER","name":"High Intensity Rehabilitation"},{"type":"OTHER","name":"Safe Transfers and Mobility Program"},{"type":"OTHER","name":"Usual Care"}],"enrollment":192,"startDate":"2026-10-01","completionDate":"2028-03","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* At least 50 years old\n* Admitted to SNF from the hospital\n* Ambulatory at admission with minimal assistance or less\n\nExclusion Criteria:\n\n* Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)\n* Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)\n* Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation\n* Subsequent SNF admission","locations":[{"facility":"University of Colorado Denver, Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Aegis Therapies","city":"Frisco","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Usual Gait Speed"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["aurora-colorado","frisco-texas"],"enrichment":{"headline":"Not a traditional drug phase: High Intensity Rehabilitation for Aging","inPlainEnglish":"This pilot study will measure the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP). This program will be implemented in patients admitted to skilled nursing facilities (SNFs) following hospitalization.","whoItsFor":["Ages 50 Years to any","At least 50 years old","Admitted to SNF from the hospital","Ambulatory at admission with minimal assistance or less"],"whoShouldSkip":["Contraindications to high-intensity resistance training (per American College of Sports Medicine Exercise Testing and Prescription)","Neurological diagnosis (e.g., cerebral vascular accident, multiple sclerosis, Parkinson's disease, traumatic brain injury)","Lower extremity weight-bearing precautions that require greater than minimal assistance with ambulation","Subsequent SNF admission"],"whatHappens":"If you join, the listed intervention(s) are High Intensity Rehabilitation, Safe Transfers and Mobility Program, or Usual Care. The registry lists allocation as randomized. This pilot study will measure the feasibility of a supplemental mobility intervention, the Safe Transfers And Mobility Program (STAMP).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 192 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.961Z"},{"nctId":"NCT07872449","title":"Risankizumab for Refractory Perianal Fistulizing Crohn's Disease","officialTitle":"Evaluation of Risankizumab for Refractory Perianal Fistulizing Crohn's Disease Using MRI-Based Remission Criteria: A Prospective, Single-Arm, Multicenter Study","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Yuki Horio","sponsorClass":"OTHER","summary":"Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL). For perianal fistulizing Crohn's disease (PFCD), combined treatment with surgical intervention (e.g., seton placement) and medical therapy centered on anti-TNF agents is standard. However, challenges remain regarding efficacy rates and evaluation criteria. Novel therapies such as stem cell therapy, JAK inhibitors, and IL-23 inhibitors are gaining attention. This study using risankizumab aims to be the first in Japan to comprehensively evaluate the therapeutic efficacy of PFCD using both clinical and MRI assessments, thereby contributing to future treatment standardization and guideline development.","conditions":["Crohn Disease","Perianal Fistula","Perianal Fistula Due to Crohn's Disease","Perianal Crohn's Disease"],"keywords":["Risankizumab","Crohn's Disease","Perianal Fistulizing Crohn's Disease","IL-23 inhibitor"],"interventions":[{"type":"DRUG","name":"Risankizumab"}],"enrollment":25,"startDate":"2026-10-01","completionDate":"2028-10-13","sex":"ALL","minAge":"15 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. 15 years of age or older\n2. Patients with an MRI-confirmed perianal fistula due to Crohn's disease\n3. Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks\n4. Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past:\n\n   ① Antibiotics (ciprofloxacin or metronidazole): Treatment lasting one month or longer.\n\n   ② Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate): Treatment for 3 months or longer.\n\n   ③ Advanced therapies (infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib): Standard therapy administered for 14 weeks or longer as induction or maintenance therapy.\n5. Patients who can agree to removal of the perianal seton by week 20 (week 20 ± 1 week) of administration, if patients already have setons inserted.\n6. Patients with draining fistulas that were drained at least 6 weeks prior to enrollment.\n7. Patients who have received a sufficient explanation regarding participation in this study, understood it fully, and provided their voluntary written consent, or patients whose legal representative received a sufficient explanation regarding participation in this study, understood it fully, and provided their voluntary written assent, if participating hospital/clinic requires.\n\nExclusion Criteria:\n\n1. Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)\n2. Patients with severe rectal and/or anal stricture and/or severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)\n3. Patients with abscesses or fluid collections exceeding 2 cm\n4. Patients for whom MRI is contraindicated\n5. Patients with a history of risankizumab, mirikizumab, or guselkumab administration\n6. Patients who are refractory to three or more prior lines of advanced therapy\n7. Patients who are intolerant to two or more prior lines of advanced therapy\n8. Patients previously treated with darvadstrocel\n9. Patients with a colostomy or ileostomy\n10. Patients with disease activity (CDAI) \\> 400\n11. Patients receiving systemic steroids\n12. Patients requiring new treatment with immunomodulators or advanced therapies during the screening period\n13. Patients undergoing cytapheresis\n14. Patients with a history of malignancy (excluding carcinoma in situ)\n15. Patients with concomitant uncontrolled liver disease, hematologic disease, gastrointestinal disease (excluding Crohn's disease), endocrine disease, pulmonary disease, cardiac disease, neurological disease, psychiatric disease, brain disease, or active infection\n16. Patients who underwent major surgery or suffered severe trauma within the past 6 months\n17. Patients who are breastfeeding, pregnant, or may be pregnant, or who plan to become pregnant during the study period\n18. Patients who showed persistent positivity for HBsAg and HBV-PCR, or seropositivity for HCV and quantitative HCV-PCR within 6 months prior to the start of the screening period\n19. Patients who received a live vaccine within 4 weeks prior to the start of risankizumab administration\n20. Patients with active tuberculosis\n21. Other patients deemed inappropriate for trial participation by the principal/ sub-investigator responsible","locations":[{"facility":"Hyogo Medical University","city":"Nishinomiya","state":"","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Coloproctology, Tokyo Yamate Medical Center","city":"Shinjuku-Ku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Department of Inflammatory Bowel Disease (IBD), Yokohama Municipal Citizen's Hospital","city":"Yokohama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Inflammatory Bowel Disease Center, YCU Medical Center, Yokohama City University","city":"Yokohama","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yuki Horio, MD, PhD","phone":"+81-798-45-6111","email":"yu-horio@hyo-med.ac.jp"},{"name":"Tetsuya Takagawa, MD, PhD","phone":"+81-798-45-6111","email":"takagawa@hyo-med.ac.jp"}],"primaryOutcomes":["The proportion of participants achieving combined fistula remission at Week 28"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":["risankizumab"],"locationSlugs":["nishinomiya-japan","shinjuku-ku-japan","yokohama-japan"],"enrichment":{"headline":"Phase 4: testing Risankizumab for Crohn Disease","inPlainEnglish":"Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders. In Japan particularly, the incidence of anal lesions is high, with approximately half of patients developing fistulas or abscesses, significantly impairing quality of life (QOL).","whoItsFor":["Ages 15 Years to any","15 years of age or older","Patients with an MRI-confirmed perianal fistula due to Crohn's disease","Patients with a draining anal fistula (maximum of 2 internal openings and maximum of 3 external openings) persisting for at least 2 weeks","Patients who have experienced inadequate response, diminished response, or intolerance to one or more of the following treatments in the past:","① Antibiotics (ciprofloxacin or metronidazole): Treatment lasting one month or longer","② Immunomodulators (azathioprine, 6-mercaptopurine, or methotrexate): Treatment for 3 months or longer","③ Advanced therapies (infliximab, adalimumab, vedolizumab, ustekinumab, and upadacitinib): Standard therapy administered for 14 weeks or longer as induction or maintenance therapy"],"whoShouldSkip":["Patients with a rectovaginal fistula at baseline (excluding past rectovaginal fistulas)","Patients with severe rectal and/or anal stricture and/or severe proctitis (defined as the presence of large ulcers exceeding 0.5 cm in the rectum)","Patients with abscesses or fluid collections exceeding 2 cm","Patients for whom MRI is contraindicated","Patients with a history of risankizumab, mirikizumab, or guselkumab administration","Patients who are refractory to three or more prior lines of advanced therapy","Patients who are intolerant to two or more prior lines of advanced therapy"],"whatHappens":"If you join, the listed intervention(s) are Risankizumab. The registry lists allocation as na. Crohn's disease is an inflammatory bowel disease characterized by relapses and remissions, causing lesions throughout the digestive tract and accompanied by diarrhea, abdominal pain, and nutritional disorders.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 25 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:26.572Z"},{"nctId":"NCT07872904","title":"FutureShape Family","officialTitle":"FutureShape Family: A Randomised Controlled Trial of an Enhanced Family Care Intervention Targeting Intergenerational Obesity","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"QUADRUPLE","sponsor":"Signe Torekov","sponsorClass":"OTHER","summary":"The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy. Parental obesity is a strong predictor of intergenerational obesity and is closely associated with a child's body composition from childhood through to adulthood.\n\nObesity pharmacotherapy effectively reduces body weight. In adults, we have shown that combining obesity pharmacotherapy with supervised exercise improves weight-loss maintenance compared with pharmacotherapy alone. Emerging evidence suggest that exercise may also limit weight regain after treatment cessation. Together with evidence linking physical activity, sleep, and eating behaviours to weight regulation, these findings support combining pharmacological treatment with interventions targeting multiple modifiable behaviours. Personalised, data-driven feedback may further facilitate sustained behavioural change, but few interventions have integrated these approaches within the family setting.\n\nThis 58-week randomized clinical trial aims to investigate the separate and combined effects of a data-driven, multimodal family-based intervention and semaglutide treatment for parents with obesity on body fat percentage and other health-related outcomes in parents and children.\n\nApproximately 400 families will be randomly assigned to one of four groups combining data-driven, multimodal family-based intervention or standard health advice with semaglutide or placebo. The data-driven, multimodal family-based intervention focuses on physical activity, diet, sleep and mental well-being.\n\nThe trial will include families with at least one parent with obesity and at least one child aged 5 to 12 years with overweight or obesity. Participating parents with obesity will receive semaglutide or placebo once weekly for 28 weeks.\n\nThe main outcomes are changes in body fat percentage in participating parents and children. Other outcomes include changes in body mass index (BMI) in parents and age- and sex-adjusted BMI, known as BMI z-score, in children. Families will participate in the main trial for 58 weeks and complete an additional follow-up assessment at week 104 after randomization.","conditions":["Obesity","Overweight"],"keywords":["Family-based intervention","Intergenerational obesity","Physical activity","Diet","Sleep","GLP-1 Receptor Agonist","Digital health","Behavioural intervention","obesity","overweight"],"interventions":[{"type":"BEHAVIORAL","name":"Family Care"},{"type":"BEHAVIORAL","name":"Standard Care"},{"type":"DRUG","name":"Semaglutide (administered by PDS290 pen-injector)"},{"type":"DRUG","name":"Placebo (administered by PDS290 pen-injector)"}],"enrollment":400,"startDate":"2026-10-01","completionDate":"2030-05-31","sex":"ALL","minAge":"5 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Family living in the same household with at least one Index Parent and one Index Child living with overweight/obesity (see below).\n* Written informed consent from all adult participants (age ≥18 years), participants between the ages of 15-17 years, and from the parental authority of the children (age \\<18 years).\n* Permanent residency in Denmark and able to speak Danish at a level to understand trial requirements.\n\nIndex Parent(s):\n\n* Living with obesity (BMI ≥30 kg/m2).\n* Biological, adoptive parent, or legal guardian of the Index child.\n* Resides with the Index child at least 50% of the time.\n* Index parent(s) must be in possession of a smartphone and able to use an app-based solution\n* A maximum of two Index Parents per family can participate in the trial.\n\nIndex Child(ren):\n\n• Aged 5 to 12 years with overweight or obesity (BMI \\> +1 BMI z-score (\\>85th percentile) for age and sex assigned at birth).\n\nOther members of the household:\n\n• All other members (non-Index parent(s) and non-Index child(ren)) of the household are invited to be included in the study and participate partly by wearing an accelerometer, wrist-worn activity tracker (e.g., a smartwatch), physical activity testing, answering questionnaires, and measurements of weight and body composition.\n\nExclusion Criteria:\n\n* Known serious chronic conditions, including type 1 or 2 diabetes\n* Known medical conditions that hinder physical activity to a significant degree.\n* Treatment for cancer at screening other than oestrogen antagonist therapy or non-melanoma skin cancer.\n* Known severe psychiatric disease, a history of major depressive episodes, or other serious psychiatric disorders.\n* Known diagnosis or treatment for an eating disorder within the last 6 months\n* Known medical conditions or use of medication significantly affecting growth (Index Child) or causing clinically significant weight gain or weight loss (Index Parent(s) or Index Child) within the last 6 months before screening.\n* Bariatric surgery and weight-related surgeries (e.g., gastric bypass) within the last two years.\n\nRelating to semaglutide (Index Parent(s)) (according to the SmPC: https://www.ema.europa.eu/en/documents/product-information/wegovy-epar-product-information\\_en.pdf)\n\n* Hypersensitivity to the active substance (semaglutide) or to any of the excipients used (Disodium phosphate, dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide, propylene glycol, phenol).\n* Known severe renal impairment (eGFR \\<30 mL/min/1.73m2), including participants with end-stage renal disease.\n* Known severe hepatic impairment.\n* Known severe stomach or gut problem, which results in delayed stomach emptying (called gastroparesis), or if you have an inflammatory bowel disease.\n* Known congestive heart failure, New York Heart Association (NYHA) class IV.\n* Known diabetic eye disease (retinopathy).\n* Known current or previous pancreatitis.\n* Pregnancy, expecting pregnancy (during the study), or breastfeeding. If a study participant is in doubt whether they could be pregnant, a urine pregnancy test is performed. Adequate contraception must be used throughout the study period and at least 2 months after discontinuation of semaglutide (semaglutide is present in the circulation for 7 weeks after the last dose).\n* A family or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma","locations":[{"facility":"University of Copenhagen, Department of Biomedical Sciences","city":"Copenhagen","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Team","phone":"+4593565828","email":"FutureShape@sund.ku.dk"},{"name":"Signe Torekov, Professor","phone":"","email":"torekov@sund.ku.dk"}],"primaryOutcomes":["Change in body fat percentage"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["copenhagen-denmark"],"enrichment":{"headline":"Phase 4: testing Semaglutide (administered by PDS290 pen-injector) for Obesity","inPlainEnglish":"The number of adults and children living with obesity is increasing worldwide. Once childhood obesity has developed, more than 80% of children carry the obesity into adulthood, with a high risk of cardiometabolic disease, poor mental health, and decreased life expectancy.","whoItsFor":["Ages 5 Years to any","Family living in the same household with at least one Index Parent and one Index Child living with overweight/obesity (see below)","Permanent residency in Denmark and able to speak Danish at a level to understand trial requirements","Living with obesity (body-mass index (BMI) ≥30 kg/m2)","Biological, adoptive parent, or legal guardian of the Index child","Resides with the Index child at least 50% of the time","Index parent(s) must be in possession of a smartphone and able to use an app-based solution","A maximum of two Index Parents per family can participate in the trial"],"whoShouldSkip":["Known serious chronic conditions, including type 1 or 2 diabetes","Known medical conditions that hinder physical activity to a significant degree","Treatment for cancer at screening other than oestrogen antagonist therapy or non-melanoma skin cancer","Known severe psychiatric disease, a history of major depressive episodes, or other serious psychiatric disorders","Known diagnosis or treatment for an eating disorder within the last 6 months","Known medical conditions or use of medication significantly affecting growth (Index Child) or causing clinically significant weight gain or weight loss (Index Parent(s) or Index Child) within the last 6 months before screening","Bariatric surgery and weight-related surgeries (e.g., gastric bypass) within the last two years"],"whatHappens":"If you join, the listed intervention(s) are Family Care, Standard Care, or Semaglutide (administered by PDS290 pen-injector). The registry lists allocation as randomized. The number of adults and children living with obesity is increasing worldwide.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 400 people at Copenhagen. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.725Z"},{"nctId":"NCT07873463","title":"Flutemetamol F 18 Injection Formulation Comparison","officialTitle":"A Multicenter, Phase 2, Open-Label, Randomized, Crossover Comparison of Two Formulations of Flutemetamol F 18 Injection","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"SINGLE","sponsor":"GE Healthcare","sponsorClass":"INDUSTRY","summary":"VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans. It helps doctors detect the presence of amyloid protein, which is associated with Alzheimer's disease and other conditions affecting memory or thinking. A new formulation of this drug, called GE-287, has been developed. This new formulation may offer advantages for patient tolerability and can be produced more reliably and efficiently.\n\nThe aim of the study is to determine whether the new formulation works as well as the current one in identifying amyloid in the brain, how it distributes in the body, and whether it is safe for use. The study will measure how much of the study drug goes to different organs (including the brain, heart, liver, and kidneys) and monitor for any side effects.","conditions":["Cognitive Dysfunction"],"keywords":["Alzheimer's disease","Cognitive impairment","PET imaging"],"interventions":[{"type":"DRUG","name":"GE-287"},{"type":"DRUG","name":"Vizamyl"},{"type":"DRUG","name":"Vizamyl"},{"type":"DRUG","name":"GE-287"}],"enrollment":20,"startDate":"2026-09-30","completionDate":"2027-02-25","sex":"ALL","minAge":"50 Years","maxAge":"110 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* The participant is at least 50 years of age\n* The participant (or a legally authorized representative of the participant) has read, signed, and dated an informed consent form (ICF) before any study procedures are performed.\n* The participant has been referred for PET imaging with VIZAMYL (flutemetamol F 18 injection) to estimate amyloid β neuritic plaque density for a) evaluation of suspected AD or other causes of cognitive decline and/or b) assessment of participant eligibility for amyloid β-directed therapy for MCI or mild AD as described in the prescribing information of the therapeutic products.\n* The participant is able and willing to comply with all study procedures, including lying supine and still in the PET scanner for at least 60 minutes (approximately 2.5 hours total per imaging session, including a break that will be approximately 30 minutes).\n* The participant is surgically sterile (has had documented bilateral oophorectomy, bilateral salpingectomy, hysterectomy, bilateral orchidectomy, and/or vasectomy with confirmation of success), postmenopausal (cessation of menses for more than 1 year), or:\n\n  1. If the participant can become pregnant, the participant must:\n\n     * use a highly effective method of contraception from Screening until 30 days after the last dose of flutemetamol F 18 injection,\n     * have negative results for serum or urine human chorionic gonadotropin pregnancy tests performed at Screening and on the imaging days (with the result known before each administration), and\n     * agree not to harvest or donate eggs until at least 30 days after the last dose of IMP.\n  2. If the participant can impregnate another person and has a sexual partner who can become pregnant, the participant and partner must use adequate contraception from Screening until 90 days after the last dose of flutemetamol F 18 injection, and the participant must agree not to harvest or donate sperm from screening through 90 days after the last dose of flutemetamol F 18 injection. If the participant has a sexual partner who is already pregnant, both the participant and the partner must provide written informed consent, and both must agree to abstain from any form of sexual contact for at least 24 hours after flutemetamol F 18 injection administration, and both must agree that once sexual contact resumes, they will use condoms until at least 90 days after administration of the last dose of flutemetamol F 18 injection.\n\nExclusion Criteria:\n\n* The participant received or plans to receive another IMP within 30 days before signing informed consent until the end of participation in this study.\n* The participant has been treated with, or is being treated with, any medicinal product (drug, biologic, or device) believed to be disease-modifying with regard to MCI or AD (such as an anti-amyloid drug), or initiation of such a medical product cannot be postponed until the participant is no longer in this study.\n* Including participation in this study, the participant will have received \\>50 mSv total radiation exposure from medical procedures/tests in the past 12 months.\n* The participant has had a procedure (therapeutic or diagnostic) involving a radioisotope and it is not possible to wait at least 4 disintegration half-lives before PET imaging.\n* The participant has a measured or estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73 m2 based on eligibility serum laboratory assessments.\n* The participant has a total bilirubin level \\>1.5X the upper limit of normal (ULN) and/or an aspartate transaminase (AST; serum glutamic-oxaloacetic transaminase \\[SGOT\\]) level \\>3X ULN, and/or an alanine transaminase (ALT, serum glutamic-pyruvic transaminase \\[SGPT\\]) level \\>3X ULN based on eligibility serum laboratory assessments.\n* Except for the participant's cognitive impairment, the participant has a history or current evidence of any condition, therapy, or other circumstance that might confound the results of the study, interfere with participation for the full duration of the study, or put the participant at undue risk as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.\n* The participant has known/suspected structural abnormalities such as a space-occupying lesion or medical devices such as stents, coils, or electrodes in any key region that may interfere with PET imaging or interpretation/analysis of image data.\n* The participant is pregnant, planning to become pregnant, or lactating.\n* The participant has known or suspected diabetes.\n* The participant is not willing or able to fast completely (except for water and any required medications) for at least 6 hours before administration of IMP until after the post-dose blood samples have been collected on each imaging day.\n* The participant has known or suspected allergy or hypersensitivity to either IMP or any of their ingredients (including PS80).\n* The participant was previously enrolled in this study.","locations":[{"facility":"Visionary Investigator Network","city":"Aventura","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Meritt Island Research, LLC dba. Flourish Research","city":"Merritt Island","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Visionary Investigator Network","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Clinical Site Partners, LLC dba Flourish Research","city":"Winter Park","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Center for Advanced Research & Education LLC dba Flourish Research Gainesville","city":"Gainesville","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paul Sherwin","phone":"+1 (609) 5103686","email":"PaulSherwin@gehealthcare.com"},{"name":"Victoria Haas","phone":"011 33 6 29 86 53 56","email":"ge287201@gehealthcare.com"}],"primaryOutcomes":["Comparison of Standard Uptake Value ratio in frontal and anterior cingulate brain region","Comparison of SUVr in posterior cingulate and precuneus brain region","Comparison of SUVr in lateral temporal brain region","Comparison of SUVr in inferolateral parietal brain region","Comparison of Standard Uptake Value (SUV) in heart","Comparison of SUV in liver","Comparison of SUV in kidneys"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["aventura-florida","merritt-island-florida","miami-florida","winter-park-florida","gainesville-georgia"],"enrichment":{"headline":"Phase 2: testing GE-287 for Cognitive Dysfunction","inPlainEnglish":"VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans. It helps doctors detect the presence of amyloid protein, which is associated with Alzheimer's disease and other conditions affecting memory or thinking.","whoItsFor":["Ages 50 Years to 110 Years","The participant is at least 50 years of age","The participant is surgically sterile (has had documented bilateral oophorectomy, bilateral salpingectomy, hysterectomy, bilateral orchidectomy, and/or vasectomy with confirmation of success), postmenopausal (cessation of menses for more than 1 year), or:","If the participant can become pregnant, the participant must:","use a highly effective method of contraception from Screening until 30 days after the last dose of flutemetamol F 18 injection,","have negative results for serum or urine human chorionic gonadotropin pregnancy tests performed at Screening and on the imaging days (with the result known before each administration), and","agree not to harvest or donate eggs until at least 30 days after the last dose of IMP"],"whoShouldSkip":["Including participation in this study, the participant will have received \\>50 mSv total radiation exposure from medical procedures/tests in the past 12 months","The participant has had a procedure (therapeutic or diagnostic) involving a radioisotope and it is not possible to wait at least 4 disintegration half-lives before PET imaging","The participant has a measured or estimated glomerular filtration rate (eGFR) \\<60 mL/min/1.73 m2 based on eligibility serum laboratory assessments","The participant has known/suspected structural abnormalities such as a space-occupying lesion or medical devices such as stents, coils, or electrodes in any key region that may interfere with PET imaging or interpretation/analysis of image data","The participant is pregnant, planning to become pregnant, or lactating","The participant has known or suspected diabetes","The participant is not willing or able to fast completely (except for water and any required medications) for at least 6 hours before administration of IMP until after the post-dose blood samples have been collected on each imaging day"],"whatHappens":"If you join, the listed intervention(s) are GE-287, Vizamyl, or Vizamyl. The registry lists allocation as randomized. VIZAMYL (flutemetamol F 18 injection) is a drug used during Positron Emission Tomography (PET) brain scans.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 20 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.328Z"},{"nctId":"NCT07874217","title":"Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study","officialTitle":"Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Oxford Brookes University","sponsorClass":"OTHER","summary":"Chronic fatiguing illnesses such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, and Long COVID are becoming a major global health challenge. They cause severe personal and social strain and have no proven, widely effective treatments. Although these conditions have different names, they share many symptoms: long-lasting fatigue that doesn't improve with rest, worsening of symptoms after activity (post-exertional malaise), difficulties with thinking (\"brain fog\"), poor sleep, and widespread pain. Increasing evidence shows that these illnesses also share similar underlying biological problems. These include ongoing inflammation, problems with the autonomic nervous system (which controls automatic body functions), poor function of the blood vessels, and reduced energy production in cells.\n\nWhole-Body Cryotherapy (WBCT) is emerging as a promising non-drug treatment that may help break these cycles. WBCT involves very short, controlled exposure to extreme cold (around -110°C to -160°C). This triggers a rapid response across the nervous, immune, and metabolic systems. The cold acts as a powerful stimulus, encouraging the body to reset imbalanced systems. A session briefly narrows blood vessels and then causes them to widen again, improving blood flow and supporting healthy vessel function. WBCT also appears to reduce inflammation, lower oxidative stress, and improve parasympathetic (\"rest-and-recover\") nervous system activity.\n\nEarly studies in ME/CFS and related conditions are encouraging. Small trials have reported reduced fatigue, clearer thinking, and better autonomic regulation after a course of WBCT sessions, with good safety. Research has also shown changes in blood-brain barrier proteins after WBCT, suggesting it may help repair \"leaky\" barriers that can drive symptoms in ME/CFS and Long COVID.\n\nBy acting on inflammation, blood flow, and nervous system balance at the same time, WBCT could offers a scientifically grounded and potentially transformative approach in understanding the mechanism behind observed treatment effect.","conditions":["ME/CFS","Fibromyalgia (FM)","Long-COVID","Control Group"],"keywords":["Cryotherapy","Fatigue","ME/CFS","Long-Covid","Fibromyalgia"],"interventions":[{"type":"DEVICE","name":"Cryotherapy"}],"enrollment":40,"startDate":"2026-10-05","completionDate":"2027-01-08","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* The study will recruit 40 adult participants (aged 18-65 years) divided across four groups: 10 healthy controls, 10 individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 10 individuals with Fibromyalgia, and 10 individuals with Long COVID.\n\nThe relatively small group size is appropriate for a pilot feasibility study, where the primary aim is to assess recruitment, retention, tolerability of the intervention, and the practicality of completing the proposed outcome measures.\n\nThe sample size reflects the exploratory nature of the study, current resource availability and funding, and the intensive intervention schedule requiring ten visits over a two-week period. In addition, there is limited UK-based evidence regarding participant responses to whole-body cryotherapy within these clinical populations, further supporting a cautious, feasibility-focused sample size.\n\nExclusion Criteria:\n\n* The primary physical risks relate to exposure to extreme cold during whole-body cryotherapy and minor discomfort associated with blood sampling. To mitigate these risks, all participants will undergo a structured medical screening using a standard WBCT medical questionnaire to identify contraindications (e.g. uncontrolled hypertension, cardiovascular disease, circulatory disorders such as Raynaud's disease, cryoglobulinaemia, severe respiratory disease, or claustrophobia). Individuals meeting exclusion criteria will not be enrolled.","locations":[{"facility":"Oxford Brookes University - Centre for Movement, Occupation and Rehabilitation Sciences (MOReS)","city":"Oxford","state":"Oxon","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Patrick Esser","phone":"+44 (0) 1865 534881","email":"pesser@brookes.ac.uk"},{"name":"Richard Baskerville","phone":"+44 (0) 1865 801213","email":"rbaskerville@brookes.ac.uk"}],"primaryOutcomes":["Feasibility outcome measurements"],"hasResults":false,"conditionSlugs":["als","long-covid"],"drugSlugs":[],"locationSlugs":["oxford-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: Cryotherapy for ME/CFS","inPlainEnglish":"Chronic fatiguing illnesses such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, and Long COVID are becoming a major global health challenge. They cause severe personal and social strain and have no proven, widely effective treatments.","whoItsFor":["Ages 18 Years to 80 Years","The study will recruit 40 adult participants (aged 18-65 years) divided across four groups: 10 healthy controls, 10 individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), 10 individuals with Fibromyalgia, and 10 individuals with Long COVID","The relatively small group size is appropriate for a pilot feasibility study, where the primary aim is to assess recruitment, retention, tolerability of the intervention, and the practicality of completing the proposed outcome measures"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Cryotherapy. The registry lists allocation as na. Chronic fatiguing illnesses such as Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), Fibromyalgia, and Long COVID are becoming a major global health challenge.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Oxford. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.231Z"},{"nctId":"NCT07874490","title":"Osimertinib and Cyclosporine A to Enhance Antitumor Efficacy in NSCLC","officialTitle":"The OCEAN Trial: A Phase II Study of Osimertinib and Cyclosporine to Enhance Antitumor Efficacy in EGFR-Mutant Non-Small Cell Lung Cancer","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"NYU Langone Health","sponsorClass":"OTHER","summary":"This single-site, biomarker-enriched, randomized Phase II study will evaluate osimertinib with or without cyclosporine A (CsA) in metastatic epidermal growth factor receptor (EGFR )-mutant non-small cell lung cancer (NSCLC) \\[exon 19 deletion or L858R\\]. All consented, baseline circulating tumor DNA (ctDNA)-positive patients receive a 3-week osimertinib run-in; those with persistent ctDNA (\"shedders\") are randomized 1:1 to continue osimertinib or osimertinib+CsA. Plasma is collected approximately every 3 weeks in both arms for molecular response monitoring. The investigators plan to enroll 60 patients with approximately 40 \"shedders\" randomized with 20 enrolled in each arm. All patients will be treated with osimertinib daily throughout the study; the combination of osimertinib+CsA will receive CsA. Imaging will be performed as per standard of care.","conditions":["Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor"],"keywords":["NSCLC","Non-Small Cell Lung Cancer","osimertinib","cyclosporine A","CsA"],"interventions":[{"type":"DRUG","name":"Osimertinib"},{"type":"DRUG","name":"Cyclosporine A (CsA)"},{"type":"DEVICE","name":"ctDNA Biopsy Panel"}],"enrollment":60,"startDate":"2026-10","completionDate":"2030-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age≥18 years, able to give informed consent.\n* Standard of care (SOC) biopsy-proven metastatic non-small cell lung cancer, confirmed at NYU Langone Health (NYULH)\n* Somatic activating mutation in EGFR exon 19 deletion or EGFR L858R in pre-treatment tumor biopsy or cytology from pleural fluid or cfDNA as detected by SOC testing.\n* Either have not started a prior EGFR TKI therapy, or may have started osimertinib within 3 weeks of confirming eligibility and enrollment criteria of measurable disease per approval of PI, with no prior chemotherapy for treatment of metastatic disease (adjuvant therapy \\> 6 months prior to study start is acceptable).\n* Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per treating investigator. If a patient has already started on osimertinib there must be available pre-osimertinib baseline tumor assessments, to be utilized for RECIST 1.1 assessment.\n* ECOG performance status of 0-2\n* Adequate organ function\n* Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Any radiotherapy within 1 week prior to starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib. No washout window needed if the patients started on Osimertinib. They should continue on Osimertinib. If patients received radiation prior to Osimertinib, they should wait for 7 days from the last day of radiation to start Osimertinib. If patients are already on osimertinib at the time of initial consent and they happened to also have radiation prior to starting on osimertinib, they do not need a washout in order to meet eligibility criteria for the study.\n* Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib.\n* Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater.\n* Currently receiving (or unable to stop prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4. All patients must try to avoid concomitant use of any medications, herbal supplements and/or ingestion of foods with known inducer effects on CYP3A4.\n* Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial.\n* Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of Osimertinib or cyclosporine A.\n* Mean resting corrected QT interval (QTcF) \\> 470 msec\n* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block, third degree heart block and second degree heart block.\n* Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, electrolyte abnormalities (including: Serum/Plasma potassium \\<LLN, Serum/Plasma Magnesium \\<LLN; Serum/Plasma Calcium \\<LLN), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes. If concomitant medication can not be discontinued, please notify and confirm with MSK PI prior to enrollment.\n* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease.\n* History of hypersensitivity to active or inactive excipients of osimertinib or drugs with a similar chemical structure or class to osimertinib.\n* History of hypersensitivity to active or inactive excipients of cyclosporine A or drugs with a similar chemical structure or class to cyclosporine A.\n* History of autoimmune disease (excluding Hashimoto's thyroiditis).","locations":[{"facility":"NYU Langone Heath","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Elaine Shum, MD","phone":"212-731-5662","email":"CancerTrials@nyulangone.org"}],"primaryOutcomes":["Proportion of Patients Achieving Complete Clearance of Plasma EGFR Mutations"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor","inPlainEnglish":"This single-site, biomarker-enriched, randomly assigned Phase II study will evaluate osimertinib with or without cyclosporine A (CsA) in metastatic epidermal growth factor receptor (EGFR )-mutant non-small cell lung cancer (NSCLC) \\[exon 19 deletion or L858R\\]. All consented, baseline circulating tumor DNA (ctDNA)-positive patients receive a 3-week osimertinib run-in; those with persistent ctDNA (\"shedders\") are randomly assigned 1:1 to continue osimertinib or osimertinib+CsA.","whoItsFor":["Ages 18 Years to any","Standard of care (SOC) biopsy-proven metastatic non-small cell lung cancer, confirmed at NYU Langone Health (NYULH)","Somatic activating mutation in EGFR exon 19 deletion or EGFR L858R in pre-treatment tumor biopsy or cytology from pleural fluid or cfDNA as detected by SOC testing","how well you can do daily activities (ECOG score) of 0-2","Adequate organ function","Willing to use highly effective contraceptive measures if of child-bearing potential or if the patient's sexual partner is a woman of child-bearing potential"],"whoShouldSkip":["Pregnant or lactating women","Any major surgery within 2 weeks of starting treatment on protocol. The washout window only applies for patients who have not started Osimertinib","Treatment with an investigational drug within five half-lives of the compound or 3 months, whichever is greater","Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in the trial","Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required","Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the tablets or previous significant bowel resection that would preclude adequate absorption of Osimertinib or cyclosporine A","Mean resting corrected QT interval (QTcF) \\> 470 msec"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib, Cyclosporine A (CsA), or ctDNA Biopsy Panel. The registry lists allocation as randomized. This single-site, biomarker-enriched, randomly assigned Phase II study will evaluate osimertinib with or without cyclosporine A (CsA) in metastatic epidermal growth factor receptor (EGFR )-mutant non-small cell lung cancer (NSCLC) \\[exon 19 deletion or L858R\\].","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 60 people at New York. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.680Z"},{"nctId":"NCT07874633","title":"A Study to Learn About the Study Medicine Called PF-08653944 Taken Once-Monthly Compared to Placebo in Chinese Adults With Overweight or Obesity","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-MONTHLY PF 08653944 IN CHINESE ADULTS WITH OVERWEIGHT OR OBESITY","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions. The purpose of this study is to learn whether berobenatide (PF-08653944) is safe and effective for adults in China who are overweight or obese. Researchers will compare berobenatide with a placebo. A placebo looks like study treatment but does not contain active medicine.\n\nAbout 432 adults will take part in this study. This study is seeking adults who\n\n* are obese\n* are overweight with certain weight-related health conditions. Some participants may also have type 2 diabetes. Specific eligibility requirements will be reviewed by the study doctor before enrollment.\n\nParticipants will be randomly assigned to receive either berobenatide or placebo. Study treatment will be administered as a shot under the skin. All participants will also receive lifestyle counseling throughout the study.\n\nResearchers will monitor participants throughout the study. They will assess participants' body weight, overall health, and any reactions that may occur. During the study, participants will attend study visits and complete study-related assessments.\n\nParticipants may take part in the study for up to approximately 59 weeks. This period includes screening, treatment, and follow-up visits. The information learned from this study may help researchers better understand whether berobenatide could be a treatment option for adults living with overweight or obesity.","conditions":["Obesity","Overweight"],"keywords":["Obesity","Overweight","Weight Management","Weight Reduction","Body Weight","Chronic Weight Management","Adults With Obesity","Adults With Overweight","Metabolic Diseases"],"interventions":[{"type":"DRUG","name":"Berobenatide"},{"type":"OTHER","name":"Placebo"}],"enrollment":432,"startDate":"2026-10-28","completionDate":"2028-06-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥18 years of age.\n* BMI ≥28 kg/m²; or BMI ≥24 kg/m² and \\<28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D.\n* At least one prior unsuccessful dietary weight-loss attempt.\n\nExclusion Criteria:\n\n* Significant recent weight change (\\>5% within 3 months).\n* Type 1 diabetes mellitus.\n* History of pancreatitis.\n* Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2).\n* Recent bariatric surgery or obesity procedures.\n* Pregnancy or breastfeeding.","locations":[{"facility":"The Second People's Hospital of Hefei","city":"Hefei","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Peking University People's Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huizhou Central People's Hospital","city":"Huizhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Zhengzhou University","city":"Zhengzhou","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Jiangxi Provincial People's Hospital","city":"Nanchang","state":"Jiangxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Percent change from baseline in body weight"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["hefei-china","beijing-china","huizhou-china","zhengzhou-china","nanjing-china","nanchang-china"],"enrichment":{"headline":"Phase 3: testing Berobenatide for Obesity","inPlainEnglish":"Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems. These problems include heart disease, type 2 diabetes (a condition that causes high blood sugar), and other medical conditions.","whoItsFor":["Ages 18 Years to any","Adults ≥18 years of age","body-mass index (BMI) ≥28 kg/m²; or body-mass index (BMI) ≥24 kg/m² and \\<28 kg/m² with at least one of the following weight-related co-morbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or T2D","At least one prior unsuccessful dietary weight-loss attempt"],"whoShouldSkip":["Significant recent weight change (\\>5% within 3 months)","Type 1 diabetes mellitus","History of pancreatitis","Personal or family history of Medullary Thyroid Carcinoma (MTC) or Multiple endocrine neoplasia type 2 (MEN2)","Recent bariatric surgery or obesity procedures","Pregnancy or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Berobenatide, or Placebo. The registry lists allocation as randomized. Overweight and obesity are long-term health conditions that can increase the possibility of serious health problems.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 432 people at 6 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.836Z"},{"nctId":"NCT07874815","title":"Ensifentrine (MK-5884) Study for the Prevention of Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (SOC) (MK-5884-031/RPL554/ENHANCE-3)","officialTitle":"A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ensifentrine (MK-5884) Versus Placebo for the Prevention of COPD Exacerbations in Adults With a History of Moderate or Severe Exacerbations While Receiving Standard of Care (ENHANCE-3)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Merck Sharp & Dohme LLC","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the efficacy and safety of ensifentrine (MK-5884) compared with placebo for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also evaluate the efficacy of ensifentrine compared with placebo in improving lung function, improving health related quality of life, and preventing severe exacerbations.","conditions":["Pulmonary Disease, Chronic Obstructive"],"keywords":[],"interventions":[{"type":"DRUG","name":"Ensifentrine"},{"type":"OTHER","name":"Placebo"},{"type":"DRUG","name":"Standard of Care (SOC)"}],"enrollment":2136,"startDate":"2026-11-02","completionDate":"2029-04-29","sex":"ALL","minAge":"40 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion Criteria include but are not limited to:\n\n* Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization\n* Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening\n* Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening\n* Is a current or former cigarette smoker with a history of cigarette smoking ≥10 packyears at Screening (number of pack-years = \\[number of cigarettes per day/20\\] × number of years smoked \\[e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years\\]). Pipe, cigar, and/or e-cigarette/vape use cannot be used to calculate pack-year history.\n* Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and \\<70% of Predicted Normal Value\n\nExclusion Criteria:\n\nExclusion criteria include but are not limited to:\n\n* Has a history of intubation for respiratory failure within 1 year of Screening\n* Is receiving long-term oxygen therapy defined as \\>15 hours per day\n* Uses chronic bilevel positive airway pressure for treatment of respiratory condition unless for treatment of sleep apnea at a stable pressure for at least 3 months\n* Is currently using or has used a biologic therapy (e.g., dupilumab, mepolizumab, or tozorakimab) within 6 months prior to Screening Visit\n* Has history of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.","locations":[{"facility":"Family First Medical Research Center ( Site 4458)","city":"Hialeah Gardens","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Advanced Pulmonary Research Institute ( Site 4427)","city":"Loxahatchee Groves","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research ( Site 4464)","city":"Valparaiso","state":"Indiana","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHEAR Center LLC ( Site 4407)","city":"The Bronx","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Lowcountry Lung & Critical Care, PA ( Site 4413)","city":"Charleston","state":"South Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"M3 Wake Research, Inc. ( Site 4440)","city":"Chattanooga","state":"Tennessee","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Victoria Clinical Research Group ( Site 4430)","city":"Victoria","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Toll Free Number","phone":"1-888-577-8839","email":"Trialsites@msd.com"}],"primaryOutcomes":["Annualized Rate of Adjudicated Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations"],"hasResults":false,"conditionSlugs":["als","copd"],"drugSlugs":[],"locationSlugs":["hialeah-gardens-florida","loxahatchee-groves-florida","valparaiso-indiana","the-bronx-new-york","charleston-south-carolina","chattanooga-tennessee","victoria-texas"],"enrichment":{"headline":"Phase 3: testing Ensifentrine for Pulmonary Disease, Chronic Obstructive","inPlainEnglish":"This study wants to measure the how well it works and safety of ensifentrine (MK-5884) compared with dummy treatment (placebo) for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment. The study will also measure the how well it works of ensifentrine compared with dummy treatment (placebo) in improving lung function, improving health related quality of life, and preventing severe exacerbations.","whoItsFor":["Ages 40 Years to 80 Years","who can join include but are not limited to:","Has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) that was made ≥12 months prior to randomization","Has been on the stable treatment with the same standard of care (SOC) with long-acting muscarinic antagonist (LAMA)/long-acting beta-2 agonist (LABA)/inhaled corticosteroid (ICS) or LAMA/LABA (if ICS is not appropriate), for at least 2 months prior to Screening","Has a documented history of ≥1 moderate or severe COPD exacerbation while on standard of care (SOC) within 1 year of Screening","Has post-bronchodilator forced expiratory volume 1 (FEV1) ≥25% and \\<70% of Predicted Normal Value"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"If you join, the listed intervention(s) are Ensifentrine, Placebo, or Standard of Care (SOC). The registry lists allocation as randomized. This study wants to measure the how well it works and safety of ensifentrine (MK-5884) compared with dummy treatment (placebo) for the prevention of moderate and severe COPD exacerbation in adults with COPD and a history of exacerbations while receiving SOC treatment.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 2,136 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.654Z"},{"nctId":"NCT07874828","title":"PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study","officialTitle":"PROACT AYA: Preventing Overweight/Obesity-Associated Cardiotoxicity With Tirzepatide In Adolescent And Young Adult Cancer Survivors - A Phase 2 Single-Arm, Single-Center Feasibility Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"M.D. Anderson Cancer Center","sponsorClass":"OTHER","summary":"This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic. The study will enroll young adults (18-39 years) with soft tissue or bone sarcoma who are overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²), have completed Dox-based chemotherapy (≥300 mg/m²) approximately three months prior to enrollment, and have preserved LVEF (≥50%) preenrollment.","conditions":["Sarcoma,Soft Tissue"],"keywords":["Overweight","Obesity"],"interventions":[{"type":"DRUG","name":"Tirzepatide"}],"enrollment":30,"startDate":"2026-10-14","completionDate":"2034-12-31","sex":"ALL","minAge":"18 Years","maxAge":"39 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-39 years at enrollment\n* Histologically confirmed soft tissue or bone sarcoma with treatment that included Dox ≥ 300 mg/m².\n* Completed chemotherapy 3 months prior to enrollment; patient must be in remission at the time of enrollment with no planned systemic therapy, radiation therapy, or surgical oncologic intervention anticipated within the next 12 months.\n* Overweight (BMI 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (BMI ≥30 kg/m²) at the time of enrollment.\n* LVEF ≥ 50% at the time of enrollment with no symptoms of heart failure (NYHA class I-II).\n* ECOG performance status ≤2 (equivalent to Karnofsky ≥60%) at the time of enrollment.\n* Reproductive considerations:\n\n  * Women of childbearing potential must agree to use adequate contraception (hormonal, barrier, IUD, or abstinence) beginning at enrollment and continuing for the duration of Tirz therapy.\n  * Men must agree to use adequate contraception during study treatment and for 4 months after completion of Tirz.\n  * Pregnancy testing will follow MD Anderson Policy CLN1114.\n* Ability to provide informed consent and willingness to comply with all study procedures, assessments, and follow-up requirements.\n\nExclusion Criteria:\n\n* Preexisting diabetes mellitus requiring pharmacologic therapy.\n* Prior or current use of GLP-1 receptor agonists.\n* Ongoing active malignancy or ongoing systemic therapy for cancer treatment.\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia.\n* History of pancreatitis, medullary thyroid carcinoma, or MEN2.\n* Current participation in another interventional trial.\n* Pregnancy or breastfeeding.\n* Contraindication to GLP-1/GIP receptor agonists.\n* Psychiatric illness/social situations that would limit compliance with study requirements.","locations":[{"facility":"UT MD Anderson","city":"Houston","state":"Texas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Efstratios Koutroumpakis, MD","phone":"(713) 563-5439","email":"ekoutroumpakis@mdanderson.org"}],"primaryOutcomes":["Safety and Adverse Events (AEs)"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["houston-texas"],"enrichment":{"headline":"Phase 2: testing Tirzepatide for Sarcoma,Soft Tissue","inPlainEnglish":"This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic. The study will enroll young adults (18-39 years) with soft tissue or bone sarcoma who are overweight (body-mass index (BMI) 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (body-mass index (BMI) ≥30 kg/m²), have completed Dox-based chemotherapy (≥300 mg/m²) approximately three months prior to enrollment, and have preserved LVEF (≥50%) preenrollment.","whoItsFor":["Ages 18 Years to 39 Years","Age 18-39 years at enrollment","Histologically confirmed soft tissue or bone sarcoma with treatment that included Dox ≥ 300 mg/m²","Completed chemotherapy 3 months prior to enrollment; patient must be in remission at the time of enrollment with no planned systemic therapy, radiation therapy, or surgical oncologic intervention anticipated within the next 12 months","Overweight (body-mass index (BMI) 25-29.9 kg/m² with ≥1 cardiovascular risk factor) or obese (body-mass index (BMI) ≥30 kg/m²) at the time of enrollment","LVEF ≥ 50% at the time of enrollment with no symptoms of heart failure (NYHA class I-II)","how well you can do daily activities (ECOG score) ≤2 (equivalent to Karnofsky ≥60%) at the time of enrollment","Reproductive considerations:"],"whoShouldSkip":["Preexisting diabetes mellitus requiring pharmacologic therapy","Prior or current use of GLP-1 receptor agonists","Ongoing active malignancy or ongoing systemic therapy for cancer treatment","Patients who have not recovered from side effects due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia","History of pancreatitis, medullary thyroid carcinoma, or MEN2","Current participation in another treatment trial","Pregnancy or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide. The registry lists allocation as na. This is a prospective, single-arm, open-label feasibility trial conducted at the MD Anderson Sarcoma Center and Cardio-Oncology Clinic.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Houston. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.025Z"},{"nctId":"NCT07875062","title":"Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis","officialTitle":"A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Mechanistic Effects of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) on the Gut and Vaginal Microbiome, Gastrointestinal Well-Being, and Quality-of-Life Parameters in Women With Endometriosis and Co-Existing Gastrointestinal Symptoms","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"LOAM Science","sponsorClass":"OTHER","summary":"This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.","conditions":["Endometriosis","Microbiome Dysbiosis","Gastrointestinal Symptoms"],"keywords":["Endometriosis","Fiber","Prebiotic","Gut Microbiome","Vaginal Microbiome","Gastrointestinal"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Fiber"},{"type":"DIETARY_SUPPLEMENT","name":"Placebo"}],"enrollment":140,"startDate":"2026-10","completionDate":"2027-06","sex":"FEMALE","minAge":"18 Years","maxAge":"45 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed diagnosis of endometriosis (by imaging, laparoscopy, or physician clinical assessment).\n* Enriched gastrointestinal phenotype: self-reported gastrointestinal symptoms on at least 3 days per week for the preceding 3 months, including at least one of bloating, constipation, or abdominal discomfort\n* Predominantly Bristol Stool Scale Type 1-3 (constipation-predominant), or self-reported bloating as a dominant symptom.\n* Stable hormonal status: either no hormonal therapy, or stable hormonal therapy (combined oral contraceptive, progestin, or GnRH analogue) for at least 3 months with no planned change during the study.\n* Estimated habitual dietary fiber intake below 25 g/day based\n* Willingness to share menstrual cycle data.\n* Willing to maintain stable diet, physical activity, and medication regimens throughout the study.\n* Able to provide electronic informed consent and to comply with stool and vaginal self-sampling procedures.\n* Ownership and consistent use of a home body-weight scale for the duration of the study, to support the standardized at-home morning weighing protocol.\n\nExclusion Criteria:\n\n* Inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, or other organic gastrointestinal disease.\n* Severe irritable bowel syndrome (IBS) requiring active pharmacological management. Mild-to-moderate overlap is permitted as part of the enrichment strategy.\n* Antibiotic use within 8 weeks prior to baseline or anticipated during the study.\n* Probiotic, prebiotic, or fiber supplement use within 4 weeks prior to baseline (washout required).\n* Major gastrointestinal surgery, excluding appendectomy or cholecystectomy more than 6 months prior, and excluding surgical intervention for endometriosis.\n* Current pregnancy, breastfeeding, or plans to conceive during the study.\n* Severe constipation requiring regular prescription laxatives.\n* Significant renal, hepatic, cardiac, or endocrine disease.\n* Active malignancy.\n* Known allergy or intolerance to any LOAM fiber component.\n* Significant dietary change or weight-loss intervention within the preceding 3 months.\n* Use of medications known to significantly alter gut motility or the microbiome (for example, recent metformin initiation, regular opioid use, or chronic proton-pump inhibitor use), per investigator judgment.\n* Any surgical intervention for endometriosis (including laparoscopy, laparotomy, or endometrioma excision) within the 6 months prior to screening, as post-surgical physiological changes may confound symptom and biomarker assessments.","locations":[{"facility":"Alethios","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Bryce Jarman, PhD","phone":"323-325-1327","email":"bryce@loamscience.com"}],"primaryOutcomes":["Incidence and severity of GI adverse events (AEs) and discontinuations."],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Not a traditional drug phase: Fiber for Endometriosis","inPlainEnglish":"This study is a neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment study that evaluates the whether it is safe and how hard side effects are to live with of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to measure the whether it is safe and how hard side effects are to live with of the supplement, measured by the incidence and severity of gastrointestinal side effects (AEs) and discontinuations.","whoItsFor":["Ages 18 Years to 45 Years","Women only","Confirmed diagnosis of endometriosis (by imaging, laparoscopy, or physician clinical assessment)","Enriched gastrointestinal phenotype: self-reported gastrointestinal symptoms on at least 3 days per week for the preceding 3 months, including at least one of bloating, constipation, or abdominal discomfort","Predominantly Bristol Stool Scale Type 1-3 (constipation-predominant), or self-reported bloating as a dominant symptom","Stable hormonal status: either no hormonal therapy, or stable hormonal therapy (combined oral contraceptive, progestin, or GnRH analogue) for at least 3 months with no planned change during the study","Estimated habitual dietary fiber intake below 25 g/day based","Willingness to share menstrual cycle data","Willing to maintain stable diet, physical activity, and medication regimens throughout the study"],"whoShouldSkip":["Inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, or other organic gastrointestinal disease","Severe irritable bowel syndrome (IBS) requiring active pharmacological management. Mild-to-moderate overlap is permitted as part of the enrichment strategy","Antibiotic use within 8 weeks prior to baseline or anticipated during the study","Probiotic, prebiotic, or fiber supplement use within 4 weeks prior to baseline (washout required)","Major gastrointestinal surgery, excluding appendectomy or cholecystectomy more than 6 months prior, and excluding surgical intervention for endometriosis","Current pregnancy, breastfeeding, or plans to conceive during the study","Severe constipation requiring regular prescription laxatives"],"whatHappens":"If you join, the listed intervention(s) are Fiber, or Placebo. The registry lists allocation as randomized. This study is a neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment study that evaluates the whether it is safe and how hard side effects are to live with of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 140 people at San Francisco. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.110Z"},{"nctId":"NCT07876648","title":"Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis","officialTitle":"Prospective Trial of [18F]AlF-FAPI-74 for PET Imaging of Fibroblast Activation Protein in Patients With Endometriosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Universitaire Ziekenhuizen KU Leuven","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether \\[18F\\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis. The main aims are: (i) How well does \\[18F\\]AlF-FAPI-74 PET/CT identify endometriosis lesions compared with findings during laparoscopy? (ii) Can PET/CT identify additional lesions that may not be seen on ultrasound or MRI? (iii) Can ultra-high-resolution NeuroEXPLORER PET/CT improve the detection of small lesions compared with standard PET/CT? Participants will: (i) Receive an intravenous injection of \\[18F\\]AlF-FAPI-74 followed by a PET/CT scan before their planned laparoscopy. (ii) Undergo their planned laparoscopy, during which PET findings will be compared with the surgical findings and where tissue is removed with laboratory analysis. (iii) Optionally undergo an additional NeuroEXPLORER PET/CT scan after the same tracer injection. (iv) Optionally undergo a second \\[18F\\]AlF-FAPI-74 PET/CT if participants started gonadotropin-releasing hormone (GnRH) treatment after their first scan to investigate whether tracer uptake in endometriosis lesions changes during treatment.","conditions":["Endometriosis","Deep Infiltrating Endometriosis","Women","Superficial Peritoneal Endometriosis","Fibrosis"],"keywords":["[18F]AlF-FAPI-74 PET/CT","FAPI PET","Endometriosis","Superficial Peritoneal Endometriosis","Deep Infiltrating Endometriosis","Fibroblast Activation Protein","Fibroblast Activation Protein Inhibitor","Positron emission tomography","PET","Nuclear imaging","Prospective","[18F]-FAPI-74","NeuroEXPLORER"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"[18F]AlF-FAPI-74 PET/CT"},{"type":"DIAGNOSTIC_TEST","name":"[18F]AlF-FAPI-74 PET/CT"}],"enrollment":64,"startDate":"2026-09-30","completionDate":"2029-08-31","sex":"FEMALE","minAge":"18 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntary written informed consent of the participant has been obtained prior to any screening procedures.\n* At least 18 years of age at the time of signing the Informed Consent Form (ICF).\n* At least one of the following to be eligible for the DE cohort: (i) Clinical suspicion of DE, defined as the presence of deep nodule(s) during vaginal examination determined by a clinician who is an expert in endometriosis. (ii) Diagnostic suspicion of DE, defined as an ultrasound and/or MRI that shows lesions suspicious for DE.\n* At least one of the following to be eligible for the SPE cohort: (i) Clinical suspicion of SPE, defined as clinical symptoms suspicious of SPE determined by a clinician who is an expert in endometriosis. These clinical symptoms include dysmenorrhea, deep dyspareunia, dysuria, dyschezia, painful rectal bleeding or haematuria, shoulder tip pain, catamenial pneumothorax, cyclical cough/haemoptysis/chest pain, cyclical scar swelling and pain, fatigue, and infertility. (ii) Diagnostic suspicion of SPE, defined as an ultrasound and/or MRI that shows lesions suspicious for SPE.\n* Planned laparoscopy for suspected endometriosis.\n\nExclusion Criteria:\n\n* For SPE cohort: (i) Ultrasound and/or MRI with lesions suspicious of ovarian endometriosis and/or DE. (ii) Clinical symptoms suspicious of ovarian endometriosis and/or DE, determined by a clinician who is an expert in endometriosis.\n* Prior abdominal surgery less than one year ago.\n* Female who is pregnant, breastfeeding or is of childbearing potential and not using an adequate, highly effective contraceptive or no usage of contraception when sexually active are not accepted.\n* Participant is mentally or legally incapacitated, does not understand the study design or is not willing or capable to undergo all study-specific procedures.\n* Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol, or may influence the result of the study.\n* Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.\n* Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.\n* Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.\n* Participant has a known hypersensitivity to \\[18F\\]AlF-FAPI-74 or the used excipients.","locations":[{"facility":"UZ Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Niloefar Ahmadi Bidakhvidi","phone":"+3216343715","email":"niloefar.ahmadibidakhvidi@uzleuven.be"},{"name":"Elena Lara Jimenez","phone":"","email":"elena.larajimenez@uzleuven.be"}],"primaryOutcomes":["Evaluate diagnostic performance of [18F]AlF-FAPI-74 PET/CT as a non-invasive tool to diagnose deep infiltrating endometriosis and/or superficial peritoneal endometriosis, in comparison with laparoscopic findings in women with suspected endometriosis","Frequency of serious adverse device effects (SADEs) related to NeuroEXPLORER PET/CT"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["leuven-belgium"],"enrichment":{"headline":"Not a traditional drug phase: [18F]AlF-FAPI-74 PET/CT for Endometriosis","inPlainEnglish":"The goal of this clinical trial is to learn whether \\[18F\\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis. The main aims are: (i) How well does \\[18F\\]AlF-FAPI-74 PET/CT identify endometriosis lesions compared with findings during laparoscopy?","whoItsFor":["Ages 18 Years to 64 Years","Women only","Planned laparoscopy for suspected endometriosis"],"whoShouldSkip":["For SPE cohort: (i) Ultrasound and/or MRI with lesions suspicious of ovarian endometriosis and/or DE. (ii) Clinical symptoms suspicious of ovarian endometriosis and/or DE, determined by a clinician who is an expert in endometriosis","Prior abdominal surgery less than one year ago","Female who is pregnant, breastfeeding or is of childbearing potential and not using an adequate, highly effective contraceptive or no usage of contraception when sexually active are not accepted","Participant is mentally or legally incapacitated, does not understand the study design or is not willing or capable to undergo all study-specific procedures","Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol, or may influence the result of the study","Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial","Participation in an treatment Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team"],"whatHappens":"If you join, the listed intervention(s) are [18F]AlF-FAPI-74 PET/CT, or [18F]AlF-FAPI-74 PET/CT. The registry lists allocation as randomized. The goal of this clinical trial is to learn whether \\[18F\\]AlF-FAPI-74 PET/CT can help detect endometriosis in adult women who are already scheduled for laparoscopy due to suspicion of deep infiltrating endometriosis or superficial peritoneal endometriosis.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 64 people at Leuven. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.111Z"},{"nctId":"NCT07877519","title":"Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Paroxysmal Atrial Fibrillation","officialTitle":"Efficacy and Safety of Local Anesthesia With Conscious Sedation Versus General Anesthesia for Pulsed Field Ablation in Patients With Paroxysmal Atrial Fibrillation: A Prospective, Multicenter, Randomized, Controlled, Noninferiority Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"China National Center for Cardiovascular Diseases","sponsorClass":"OTHER_GOV","summary":"This prospective, multicenter, randomized, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.\n\nA total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia. Both groups will receive pulmonary vein isolation using the same pulsed field ablation strategy.\n\nThe primary outcome is recurrence of an electrocardiographically documented atrial tachyarrhythmia after an 8-week post-ablation blanking period. Recurrence is defined as atrial fibrillation, atrial flutter, or atrial tachycardia lasting at least 30 seconds through 12 months after ablation.\n\nThe study will also compare the ability of each anesthesia strategy to support successful completion of the ablation procedure, anesthesia-related and ablation-related complications, procedural efficiency, patient-reported pain and anxiety, overall procedural experience, and direct medical costs.","conditions":["Paroxysmal Atrial Fibrillation"],"keywords":["Pulsed Field Ablation","Conscious Sedation","General Anesthesia","Local Anesthesia","Catheter Ablation","Pulmonary Vein Isolation","Noninferiority Trial","VARIPULSE"],"interventions":[{"type":"PROCEDURE","name":"Local Anesthesia With Conscious Sedation"},{"type":"PROCEDURE","name":"General Anesthesia"},{"type":"DEVICE","name":"VARIPULSE Pulsed Field Ablation System"},{"type":"DRUG","name":"Compound methoxyphenamine capsules"},{"type":"DRUG","name":"Salbutamol"},{"type":"DRUG","name":"Budesonide"},{"type":"DRUG","name":"Lidocaine"},{"type":"DRUG","name":"Fentanyl"},{"type":"DRUG","name":"Midazolam"},{"type":"DRUG","name":"Tropisetron hydrochloride"},{"type":"DRUG","name":"Dexamethasone"},{"type":"DRUG","name":"Atropine"}],"enrollment":390,"startDate":"2026-06-01","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Diagnosis of paroxysmal atrial fibrillation.\n2. Age 18 to 80 years.\n3. Scheduled and willing to undergo pulsed field ablation.\n4. American Society of Anesthesiologists physical status class I to III.\n5. Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n1. Contraindication to catheter ablation, including intracardiac or atrial thrombus.\n2. Previous catheter ablation for atrial fibrillation or left atrial premature contractions.\n3. Known allergy to iodinated contrast media.\n4. Concurrent participation in another clinical trial involving a drug or medical device.\n5. Pregnancy, breastfeeding, or planned pregnancy in the near future.\n6. Active infection.\n7. Unwilling to participate or unable to comply with the study procedures and scheduled follow-up.","locations":[{"facility":"Fuwai Hospital, Chinese Academy of Medical Sciences","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Guanzhi Chen, Doctor","phone":"+8613923975318","email":"chenguanzhi@fuwai.com"},{"name":"Ligang Ding, Doctor","phone":"+8618610561552","email":"ligangding@263.net"}],"primaryOutcomes":["Percentage of Participants With Recurrence of Atrial Tachyarrhythmia After the Blanking Period"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Compound methoxyphenamine capsules for Paroxysmal Atrial Fibrillation","inPlainEnglish":"This prospective, multicenter, randomly assigned, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation. A total of 390 participants aged 18 to 80 years will be randomly assigned in a 1:1 ratio to undergo pulsed field ablation under either local anesthesia with conscious sedation or general anesthesia.","whoItsFor":["Ages 18 Years to 80 Years","Diagnosis of paroxysmal atrial fibrillation","Age 18 to 80 years","Scheduled and willing to undergo pulsed field ablation","American Society of Anesthesiologists physical status class I to III"],"whoShouldSkip":["Contraindication to catheter ablation, including intracardiac or atrial thrombus","Previous catheter ablation for atrial fibrillation or left atrial premature contractions","Known allergy to iodinated contrast media","Concurrent participation in another clinical trial involving a drug or medical device","Pregnancy, breastfeeding, or planned pregnancy in the near future"],"whatHappens":"If you join, the listed intervention(s) are Local Anesthesia With Conscious Sedation, General Anesthesia, or VARIPULSE Pulsed Field Ablation System. The registry lists allocation as randomized. This prospective, multicenter, randomly assigned, controlled, noninferiority trial will compare local anesthesia with conscious sedation and general anesthesia in patients undergoing pulsed field ablation for paroxysmal atrial fibrillation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 390 people at Beijing. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device, a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.749Z"},{"nctId":"NCT07877818","title":"A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.","officialTitle":"A Randomized, Double-blind, Placebo-controlled Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN-CN).","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"AstraZeneca","sponsorClass":"INDUSTRY","summary":"This study aims to assess the efficacy and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to placebo in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).","conditions":["Gastric","Esophagogastric Junction"],"keywords":["Durvalumab","FLOT chemotherapy"],"interventions":[{"type":"DRUG","name":"FLOT Chemotherapy"},{"type":"DRUG","name":"Durvalumab"}],"enrollment":140,"startDate":"2026-10-09","completionDate":"2029-11-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Capable of giving signed informed consent. 2. Male and/or Female, Age ≥ 18 years at the time of screening. 3. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease, GEJC includes Siewert\\* type 2 and 3 tumour and Siewert\\* type 1 tumour.\n\n  1. Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.\n  2. At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon.\n  3. No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.\n\n     4\\. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.\n\n     5\\. Adequate organ and marrow function as defined below:\n\n  <!-- -->\n\n  1. Haemoglobin ≥ 9.0 g/dL\n  2. Absolute neutrophil count ≥ 1.5 × 109/L\n  3. Platelet count ≥ 100 × 109/L\n  4. Serum bilirubin ≤ 1.5 ×ULN. This will not apply to participants with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.\n  5. ALT and AST ≤ 2.5 × ULN\n  6. Measured CL \\> 50 mL/min or Calculated CL \\> 50 mL/min as determined by Cockcroft-Gault (using actual body weight) 6. Must have a life expectancy of at least 24 weeks. 7. Body weight \\> 30 kg at enrolment and randomization. 8. Meeting tumour sample requirements (at screening) to confirm PD-L1 status.\n\nExclusion Criteria:\n\n* -1. Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis.\n\n  2\\. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour.\n\n  3\\. History of allogeneic organ transplantation. 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \\[eg, colitis or Crohn's disease\\], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis.\n\n  5\\. Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n\n  6\\. History of another primary malignancy except for\n\n  (a) Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated carcinoma in situ without evidence of disease 7. History of active primary immunodeficiency. 8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) and HIV verified by positive HIV-1 or HIV-2 antibodies.\n\n  9\\. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n\n  10\\. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.","locations":[{"facility":"Research Site","city":"Beijing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Bengbu","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changchun","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changsha","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Changzhi","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chengdu","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Chongqing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Fuzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Guangzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hangzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Hohhot","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Jinan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Kunming","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Lanzhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Meizhou","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanchang","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanjing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Nanning","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Qingdao","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shanghai","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shaoguan","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Shenyang","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Suining Shi","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Taiyuan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Wuhan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Research Site","city":"Zhengzhou","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"AstraZeneca Clinical Study Information Center","phone":"1-877-240-9479","email":"information.center@astrazeneca.com"}],"primaryOutcomes":["To compare Arm A relative to Arm B on pCR rate"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["beijing-china","bengbu-china","changchun-china","changsha-china","changzhi-china","chengdu-china","chongqing-china","fuzhou-china","guangzhou-china","hangzhou-china","hohhot-china","jinan-china","kunming-china","lanzhou-china","meizhou-china","nanchang-china","nanjing-china","nanning-china","qingdao-china","shanghai-china","shaoguan-china","shenyang-china","suining-shi-china","taiyuan-china","wuhan-china","xian-china","zhengzhou-china"],"enrichment":{"headline":"Phase 3: testing FLOT Chemotherapy for Gastric","inPlainEnglish":"This study aims to assess the how well it works and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to dummy treatment (placebo) in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).","whoItsFor":["Ages 18 Years to any","Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery","At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon","No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy","4\\. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization","5\\. Adequate organ and marrow function as defined below:","Haemoglobin ≥ 9.0 g/dL","Absolute neutrophil count ≥ 1.5 × 109/L"],"whoShouldSkip":["Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis","2\\. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour","6\\. History of another primary malignancy except for","9\\. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)","10\\. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients"],"whatHappens":"If you join, the listed intervention(s) are FLOT Chemotherapy, or Durvalumab. The registry lists allocation as randomized. This study aims to assess the how well it works and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to dummy treatment (placebo) in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 140 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.972Z"},{"nctId":"NCT07878923","title":"Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis","officialTitle":"Starting Treatment at Time Zero With Ocrevus Zunovo (STAT Ocrevus Zunovo)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Oklahoma Medical Research Foundation","sponsorClass":"OTHER","summary":"This study will compare starting Ocrevus Zunovo soon after an active episode of relapsing multiple sclerosis (MS) with starting it later. Researchers want to learn whether starting treatment sooner reduces the number of MS relapses over 18 months. They will also study changes in immune cells, blood markers, disability, and MRI scans.\n\nAbout 35 adults with relapsing MS will take part at Oklahoma Medical Research Foundation or Corewell Health West. One group will start Ocrevus Zunovo before leaving the clinic or hospital. The other group will start treatment later. Ocrevus Zunovo is given as an injection under the skin. Participants will have blood draws and follow-up visits for up to 18 months. Researchers will also review their medical records for relapses, steroid treatments, emergency department visits, and hospital stays.\n\nAbout 10 adults without MS will provide blood samples to help researchers compare immune cell measurements.","conditions":["Relapse Remitting Multiple Sclerosis"],"keywords":["Ocrevus Zunovo","Ocrelizumab","Relapsing Multiple Sclerosis","Early Treatment Initiation","B-Cell Depletion","Neurofilament Light Chain"],"interventions":[],"enrollment":45,"startDate":"2026-09-30","completionDate":"2029-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts)\n\nInclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of relapsing-remitting multiple sclerosis according to the 2017 McDonald criteria.\n* At least one gadolinium-enhancing lesion on an MRI of the brain, cervical spine, or thoracic spine within 4 weeks of relapse or hospitalization.\n\nExclusion Criteria:\n\n* Diagnosis of primary progressive multiple sclerosis.\n* Active hepatitis B.\n* Current pregnancy.\n* Allergy to gadolinium contrast or known allergy to ocrelizumab.\n* Unable to complete an MRI.\n* Contraindication to or intolerance of oral or intravenous corticosteroids.\n* Another known neurological disorder, including a history of progressive multifocal leukoencephalopathy.\n* Active bacterial, viral, fungal, or mycobacterial infection, or a history of recurrent aspiration pneumonia requiring antibiotic treatment.\n* A condition that may require chronic systemic corticosteroids or immunosuppressants during the study.\n* Treatment with an anti-CD20 or other B-cell-depleting therapy within 6 months before enrollment.\n* Active cancer or malignancy.\n* Prisoner status.\n* Limited English-speaking capacity.\n* Unable to provide informed consent.\n\nHealthy Control Participants\n\nInclusion Criteria:\n\n* Age 18 years or older.\n* Able and willing to provide written informed consent and undergo study blood draws.\n* No diagnosis or history of multiple sclerosis, clinically isolated syndrome, or another inflammatory or demyelinating disorder of the central nervous system.\n* In generally good health, as determined by medical history and investigator review.\n\nExclusion Criteria:\n\n* Multiple sclerosis, clinically isolated syndrome, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica spectrum disorder (NMOSD), or another neurological disorder that may affect study results.\n* An autoimmune, inflammatory, hematologic, or immunodeficiency disorder that may affect B- or T-cell measurements.\n* Active bacterial, viral, fungal, or mycobacterial infection at enrollment or blood collection.\n* Current use of a disease-modifying therapy, B-cell-depleting therapy, systemic immunosuppressant, immunomodulatory therapy, or chronic systemic corticosteroids.\n* Active cancer or malignancy, except adequately treated localized skin cancer if permitted by the investigator.\n* Current pregnancy.\n* A medical condition that, in the investigator's judgment, could increase risk, interfere with participation, or affect interpretation of immune cell or biomarker results.\n* Unable or unwilling to undergo blood collection.\n* Prisoner status.\n* Limited English-speaking capacity.\n* Unable to provide informed consent.","locations":[{"facility":"Oklahoma Medical Research Foundation","city":"Oklahoma City","state":"Oklahoma","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Meerah Khan, MPH","phone":"6312205983","email":"khanm@omrf.org"},{"name":"Yang Mao-Draayer, MD, PhD","phone":"4052716242","email":"Yang-Mao-Draayer@omrf.org"}],"primaryOutcomes":["Annualized Relapse Rate Over 18 Months."],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":["ocrelizumab"],"locationSlugs":["oklahoma-city-oklahoma"],"enrichment":{"headline":"Early Versus Delayed Start of Ocrevus Zunovo for Relapsing Multiple Sclerosis","inPlainEnglish":"This study will compare starting Ocrevus Zunovo soon after an active episode of relapsing multiple sclerosis (MS) with starting it later. Researchers want to learn whether starting treatment sooner reduces the number of MS relapses over 18 months.","whoItsFor":["Ages 18 Years to any","Participants With Relapsing Multiple Sclerosis (Rapid-Start and Delayed-Start Cohorts)","Age 18 years or older","Diagnosis of relapsing-remitting multiple sclerosis according to the 2017 McDonald criteria","At least one gadolinium-enhancing lesion on an MRI of the brain, cervical spine, or thoracic spine within 4 weeks of relapse or hospitalization"],"whoShouldSkip":["Diagnosis of primary progressive multiple sclerosis","Active hepatitis B","Allergy to gadolinium contrast or known allergy to ocrelizumab","Unable to complete an MRI","Contraindication to or intolerance of oral or intravenous corticosteroids","Another known neurological disorder, including a history of progressive multifocal leukoencephalopathy","Active bacterial, viral, fungal, or mycobacterial infection, or a history of recurrent aspiration pneumonia requiring antibiotic treatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 45 people at Oklahoma City. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.991Z"},{"nctId":"NCT07879885","title":"An Open-label Study of HS-20137 in Participants With Moderate-to-Severe Plaque Psoriasis","officialTitle":"An Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of HS-20137, an Anti-IL-23 Monoclonal Antibody, in Participants With Moderate-to-severe Plaque Psoriasis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Hansoh BioMedical R&D Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and efficacy of HS-20137 in the treatment of participants with moderate-to-severe plaque psoriasis","conditions":["Moderate-to-severe Plaque Psoriasis"],"keywords":["Plaque Psoriasis; HS-20137; Interleukin-23"],"interventions":[{"type":"BIOLOGICAL","name":"HS-20137"}],"enrollment":390,"startDate":"2025-07-31","completionDate":"2027-03-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 18 and above, male or female;\n2. Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;\n3. During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥3%; b) PASI≥3;\n4. Voluntarily participate in the research, have the ability and willingness to complete the research according to the research protocol, and sign the informed consent.\n\nExclusion Criteria:\n\n1. History of an allergic reaction following prior use of a biologic agent, allergy to known drug components, or a history of severe food or drug allergy;\n2. Confirmation of other types of psoriasis, including but not limited to guttiform psoriasis, pustular psoriasis, erythrodermic psoriasis, drug-induced exacerbation of psoriasis (including beta-blockers, non-steroidal anti-inflammatory drugs, antimalarial drugs, interferon, calcium channel blockers, or lithium induced psoriasis) from the screening period to the time before the first dose;\n3. Other skin lesions, chronic inflammatory diseases or autoimmune diseases, including but not limited to systemic lupus erythematosus, Sjogren's syndrome, skin sclerosis, etc., assessed by the investigator and other factors that may affect the efficacy evaluation or assessed by other researchers before the first dose;\n4. Primary treatment failure occurred with previous use of similar investigatory drugs (including marketed ulinumab, gusecciumab, Tiricizumab, Lisenciumab, and IL-23 target investigatory drugs under development) (the minimum treatment standard was not reached 12 weeks after the first treatment);\n5. Use of the following drugs before the first dose:\n\n   1. Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;\n   2. 1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;\n   3. Prior to the first dose, use of other biologics for the treatment of psoriasis (including but not limited to TNF α inhibitors, secukinumab, ixekizumab, ustekinumab, guselkumab, tildrakizumab, risankizumab, and investigational IL 23 targeting drugs) without meeting the protocol required time interval for re administration of the original biologic;\n   4. use of lymphocyte migration regulators or B cell and T cell regulators (including but not limited to abatacept, telitacicept, etc.), within 3 months before dose, or 6 months before screening, (whichever is older) use of B-cell-specific scavenging drugs (including but not limited to rituximab, inebilizumab, etc.);\n6. A history of chronic recurrent infection, or opportunistic infection in the 6 months prior to screening, or hospitalization for a serious infectious disease or intravenous antibiotic use in the 2 months prior to randomization, with a confirmed or suspected illness in the 1 week prior to the first dose. And Other circumstances determined by the investigator to be unsuitable for further study participation.","locations":[{"facility":"China-Japan Friendship Hospital","city":"Beijing","state":"Beijng","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Number of Participants with Adverse Events","Changes From Baseline in Clinical Laboratory Test Results","Changes From Baseline in Physical Examination Findings","Changes From Baseline in Vital Signs","Incidence of Clinically Significant Electrocardiogram (ECG) Abnormalities"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing HS-20137 for Moderate-to-severe Plaque Psoriasis","inPlainEnglish":"This study wants to measure the safety and how well it works of HS-20137 in the treatment of participants with moderate-to-severe plaque psoriasis","whoItsFor":["Ages 18 Years to any","Adults aged 18 and above, male or female;","Diagnosed plaque psoriasis for at least 6 months before randomization, with or without psoriatic arthritis;","During screening and randomization, the severity of plaque psoriasis was moderate to severe, and the following conditions should be met: a) BSA≥3%; b) PASI≥3;"],"whoShouldSkip":["History of an allergic reaction following prior use of a biologic agent, allergy to known drug components, or a history of severe food or drug allergy;","Use of the following drugs before the first dose:","Use of topical treatment drugs that affect the evaluation of psoriasis within 2 weeks before the first dose;","1 weeks before the first administration, Use of phototherapy, traditional systemic therapy drugs, small molecule targeted drugs that may affect the evaluation of psoriasis;"],"whatHappens":"If you join, the listed intervention(s) are HS-20137. The registry lists allocation as na. This study wants to measure the safety and how well it works of HS-20137 in the treatment of participants with moderate-to-severe plaque psoriasis","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 390 people at Beijing. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.585Z"},{"nctId":"NCT07880067","title":"Effects of Surgery on Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea","officialTitle":"The Effects of Surgery on Improving Oral Frailty and Dysphagia in Patients With Obstructive Sleep Apnea (OSA): A Prospective Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Sun Yat-sen University","sponsorClass":"OTHER","summary":"Dysphagia is a commonly reported complaint among patients with obstructive sleep apnea (OSA), particularly those who have undergone upper-airway (oropharyngeal) surgery. However, how surgical treatment for OSA affects swallowing function and oral function (oral frailty) remains unclear.\n\nThis prospective cohort study recruits adults with moderate-to-severe OSA from the sleep medicine clinic of Kaohsiung Armed Forces General Hospital, Taiwan. Participants choose their own treatment as part of routine care; the study does not assign or influence treatment. Participants who undergo OSA surgery form the surgery group, and those who receive non-surgical treatment (e.g., CPAP) or no treatment form the non-surgical group. Swallowing difficulty (EAT-10) and oral frailty (seven oral hypofunction indicators) are assessed before treatment and at 1, 3, and 6 months after treatment.","conditions":["OSA - Obstructive Sleep Apnea","Dysphagia","Oral Frailty"],"keywords":["obstructive sleep apnea","oral frailty","oral hypofunction","dysphagia","swallowing","upper airway surgery","uvulopalatopharyngoplasty","tongue pressure"],"interventions":[{"type":"PROCEDURE","name":"Upper airway surgery for OSA"},{"type":"OTHER","name":"Non-surgical management"}],"enrollment":450,"startDate":"2026-06-12","completionDate":"2028-12-31","sex":"ALL","minAge":"20 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosed by a physician with moderate-to-severe obstructive sleep apnea (apnea-hypopnea index \\>= 15 events/hour)\n* Aged 20 years or older\n* Willing to receive next-step treatment for obstructive sleep apnea\n* Willing to participate and provides written informed consent\n\nExclusion Criteria:\n\n* Diagnosed with central sleep apnea\n* Neuromuscular disease (e.g., stroke, Parkinson's disease)\n* Diagnosed with oral cancer and currently receiving oral treatment","locations":[{"facility":"Kaohsiung Armed Forces General Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yen-Chin Chen, RN, PhD","phone":"+886-7-5252000","email":"yenchin2427@gmail.com"},{"name":"Trista Kuo, Master","phone":"886-7-5252000","email":"osalab1130201@gmail.com"}],"primaryOutcomes":["Change in swallowing difficulty measured by the Eating Assessment Tool-10 (EAT-10)","Change in oral frailty (number of oral hypofunction indicators)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["kaohsiung-city-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: Upper airway surgery for OSA for OSA - Obstructive Sleep Apnea","inPlainEnglish":"Dysphagia is a commonly reported complaint among patients with obstructive sleep apnea (OSA), particularly those who have undergone upper-airway (oropharyngeal) surgery. However, how surgical treatment for OSA affects swallowing function and oral function (oral frailty) remains unclear.","whoItsFor":["Ages 20 Years to any","Diagnosed by a physician with moderate-to-severe obstructive sleep apnea (apnea-hypopnea index \\>= 15 events/hour)","Aged 20 years or older","Willing to receive next-step treatment for obstructive sleep apnea"],"whoShouldSkip":["Diagnosed with central sleep apnea","Neuromuscular disease (e.g., stroke, Parkinson's disease)","Diagnosed with oral cancer and currently receiving oral treatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 450 people at Kaohsiung City. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.948Z"},{"nctId":"NCT07881016","title":"French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls","officialTitle":"Cohorte française Longitudinale et Multimodale de Patients Atteints de Troubles Majeurs de l'Humeur, de Troubles Psychotiques, de Troubles du Spectre de l'Autisme et de témoins","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Fondation FondaMental","sponsorClass":"OTHER","summary":"The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60.\n\nThe main questions it aims to answer are:\n\n* Can subgroups of patients sharing a common profile of social withdrawal and anhedonia be identified, with similar clinical, genetic, biological and brain imaging characteristics?\n* Do other dimensions (cognitive flexibility, neurodevelopmental, sensory and sleep disturbances, impulsivity) and specific clinical forms (e.g., autoimmune psychosis, metabolic abnormalities) define relevant subgroups, and how do these subgroups evolve over time? Researchers will compare patients with healthy volunteers to identify clinical and biological signatures specific to each subgroup.\n\nParticipants will:\n\n* Attend an inclusion visit, two one-day assessment visits one year apart (clinical interviews, questionnaires, cognitive tests, fasting blood sample) and two brain MRI sessions\n* Optionally provide a stool sample collected at home\n* Complete questionnaires on a smartphone app and wear a connected watch (activity, sleep, heart rate) between visits\n* Take part in the study for about 18 months French Minds is conducted in about 35 centres in France and aims to include 2,500 patients and 500 healthy volunteers.","conditions":["Schizophrenia / Schizoaffective Disorder","First Episode Psychosis (FEP)","Bipolar Disorder (BD)","Major Depressive Disorder (MDD","Treatment-resistant Depression (TRD)","Autism Spectrum Disorder (ASD"],"keywords":["Anhedonia","Social Withdrawal","Precision Psychiatry","Transdiagnostic","Deep Phenotyping","Biomarkers","Brain MRI","Multi-omics","Digital Phenotyping","Autoimmune Psychosis","Cohort Study","French Minds","PEPR PROPSY"],"interventions":[{"type":"PROCEDURE","name":"3T Brain MRI"},{"type":"PROCEDURE","name":"Biological Sampling"},{"type":"OTHER","name":"Clinical, Cognitive and Digital Assessments"}],"enrollment":3000,"startDate":"2026-06-11","completionDate":"2031-06","sex":"ALL","minAge":"15 Years","maxAge":"60 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPatients:\n\n* Aged 15 to 60 years at inclusion\n* Already assessed in a FondaMental expert centre or a First Episode Psychosis (PEP) / RHU PsyCare centre\n* Signed informed consent (and consent of parents/legal guardians for minors, or of the curator for adults under curatorship)\n* Confirmed DSM-5 diagnosis at inclusion of at least one of the following:\n* Non-specific first-episode psychosis\\*\n* Schizophrenia\n* Bipolar disorder\n* Major depressive disorder (recurrent or treatment-resistant)\n* Autism spectrum disorder without intellectual disability\n* Clinical condition compatible with clinical, biological and imaging assessments\n* Affiliated with or beneficiary of a social security scheme\n* Women of childbearing potential: negative blood or urine pregnancy test at inclusion\n* Agrees to be informed of any abnormality detected on MRI \\*Non-specific first-episode psychosis: patients aged 35 or younger, with significant functional impairment (SOFAS), presenting at least two concurrent psychotic symptoms (e.g., hallucinations, delusions, disorganisation) or a first onset of a psychotic disorder (ICD-10 F20-F29) or mood disorder with psychotic features (ICD-10 F30-F39), with the episode lasting more than 7 days and first frank psychotic symptoms having appeared less than 2 years ago.\n\nHealthy volunteers (matched to patients by sex and 10-year age group):\n\n* Aged 18 to 60 years at inclusion\n* Signed informed consent\n* No personal or first-degree family history, in the past 5 years, of: non-specific first-episode psychosis, schizophrenia, bipolar disorder, recurrent or treatment-resistant depressive disorder, or autism spectrum disorder without intellectual disability\n* No current prescription of antidepressant, antipsychotic, mood stabiliser or psychostimulant for a characterised disorder\n* No use of antidepressant, antipsychotic, mood stabiliser or psychostimulant in the past 5 years\n* Condition compatible with clinical, biological and imaging assessments\n* Affiliated with or beneficiary of a social security scheme\n* Women of childbearing potential: negative blood or urine pregnancy test at inclusion\n* Agrees to be informed of any abnormality detected on MRI\n\nExclusion Criteria:\n\nPatients:\n\n* Unstabilised somatic or psychiatric condition\n* Contraindication to MRI\n* Emergency situation, inability to give consent, or under judicial protection (sauvegarde de justice)\n* Pregnant or breastfeeding women\n* Refusal to be informed of any abnormality detected on MRI\n\nHealthy volunteers:\n\n* Psychiatric disorder in the past 5 years (screened with the MINI interview)\n* Unstabilised somatic condition\n* Contraindication to MRI\n* Inability to give consent\n* Pregnant or breastfeeding women\n* Refusal to be informed of any abnormality detected on MRI","locations":[{"facility":"CHU de Besançon","city":"Besançon","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Charles Perrens","city":"Bordeaux","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Brest","city":"Brest","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Centre Hospitalier Le Vinatier","city":"Bron","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Clermont Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHU Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Louis Mourier","city":"Colombes","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hopital Albert Chenevier","city":"Créteil","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU Grenoble Alpes - Hôpital Nord","city":"Grenoble","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Lille","city":"Lille","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Sainte-Marguerite","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Montpellier","city":"Montpellier","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"GHU Sainte-Anne","city":"Paris","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"Hopital Lariboisière","city":"Paris","state":"","country":"France","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Saint-Étienne","city":"Saint-Etienne","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"CHU de Toulouse","city":"Toulouse","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null},{"facility":"CHU de Tours","city":"Tours","state":"","country":"France","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Imene Ben Mohamed","phone":"+33 7 58 25 17 49","email":"imene.benmohamed@fondation-fondamental.org"}],"primaryOutcomes":["Proportion of participants in each transdiagnostic subgroup defined by social withdrawal and anhedonia."],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder","schizophrenia"],"drugSlugs":[],"locationSlugs":["besan-on-france","bordeaux-france","brest-france","bron-france","clermont-ferrand-france","colombes-france","cr-teil-france","grenoble-france","lille-france","marseille-france","montpellier-france","paris-france","saint-etienne-france","toulouse-france","tours-france"],"enrichment":{"headline":"Not a traditional drug phase: 3T Brain MRI for Schizophrenia / Schizoaffective Disorder","inPlainEnglish":"The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure). The study includes adolescents and adults aged 15 to 60 with schizophrenia, a first psychotic episode, bipolar disorder, recurrent or treatment-resistant major depressive disorder, or autism spectrum disorder without intellectual disability, as well as healthy volunteers aged 18 to 60.","whoItsFor":["Ages 15 Years to 60 Years","Aged 15 to 60 years at inclusion","Already assessed in a FondaMental expert centre or a First Episode Psychosis (PEP) / RHU PsyCare centre","Confirmed DSM-5 diagnosis at inclusion of at least one of the following:","Non-specific first-episode psychosis\\*","Major depressive disorder (recurrent or treatment-resistant)","Autism spectrum disorder without intellectual disability","Clinical condition compatible with clinical, biological and imaging assessments"],"whoShouldSkip":["Unstabilised somatic or psychiatric condition","Contraindication to MRI","Emergency situation, inability to give consent, or under judicial protection (sauvegarde de justice)","Pregnant or breastfeeding women","Refusal to be informed of any abnormality detected on MRI","Healthy volunteers:","Psychiatric disorder in the past 5 years (screened with the MINI interview)"],"whatHappens":"If you join, the listed intervention(s) are 3T Brain MRI, Biological Sampling, or Clinical, Cognitive and Digital Assessments. The registry lists allocation as randomized. The goal of this study is to learn whether people living with severe psychiatric disorders can be grouped into more homogeneous subgroups, across usual diagnostic categories, based on two key dimensions: social withdrawal and anhedonia (reduced ability to feel pleasure).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 3,000 people at 17 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.742Z"},{"nctId":"NCT07881120","title":"Study of Afimetoran in Adults With Cutaneous Lupus Erythematosus","officialTitle":"A 2-Stage Operationally Seamless Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Afimetoran in Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Beeline Medicines Corporation","sponsorClass":"INDUSTRY","summary":"This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus, whose disease has not responded to or who cannot tolerate antimalarial therapy. Participants are assigned by chance to receive afimetoran or a matching placebo capsule once daily for 24 weeks, in addition to their existing standard lupus care. Neither participants nor study staff know which treatment is given.\n\nThe study is run in two stages under a single protocol. Stage 1 compares two doses of afimetoran with placebo to select the dose. Stage 2 compares the selected afimetoran dose with placebo to confirm efficacy and safety. After the 24-week placebo-controlled period, all participants receive afimetoran for a further 28 weeks, for a total of 52 weeks of treatment. The main measures of benefit are the change in the CLASI-A skin activity score and the proportion of participants achieving a 70% improvement in that score at Week 24.","conditions":["Cutaneous Lupus Erythematosus (CLE)","Systematic Lupus Erythematosus"],"keywords":["Subacute cutaneous lupus erythematosus (SCLE)","Chronic cutaneous lupus erythematosus (CCLE)","discoid lupus erythematosus (DLE)","Afimetoran;","BLN-256;","BMS-986256;","TLR7/TLR8 antagonist","CLASI-A","antimalarial-refractory","Afimetoran","antimalarial-intolerant"],"interventions":[{"type":"DRUG","name":"Afimetoran"},{"type":"DRUG","name":"Placebo"}],"enrollment":390,"startDate":"2026-11-03","completionDate":"2030-04","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged ≥18 years (or ≥16 years where permitted).\n2. Histologically confirmed active cutaneous lupus erythematosus (CLE) with or without systemic manifestations.\n3. Active subacute and/or chronic cutaneous lupus erythematosus, including discoid lupus erythematosus.\n4. Moderate to severe skin disease activity.\n5. Refractory, intolerant, or inadequately controlled on antimalarial therapy.\n6. Willing and able to comply with study requirements.\n7. Agreement to protocol-specified contraception requirements\n\nExclusion Criteria:\n\n1. Severe lupus nephritis or severe neuropsychiatric SLE\n2. Drug-induced lupus\n3. Active or chronic clinically significant infections, including HIV, hepatitis B, hepatitis C, active tuberculosis, untreated latent tuberculosis, or uncontrolled congestive heart failure\n4. Significant concurrent autoimmune disease other than lupus-related conditions permitted by the protocol\n5. Active malignancy or recent history of certain cancers\n6. Other dermatologic conditions that may interfere with study assessments\n7. Recent use of prohibited medications or investigational therapies\n8. Prior treatment with afimetoran or another TLR7/TLR8 antagonist\n9. Clinically significant laboratory abnormalities or severe organ dysfunction\n10. Pregnancy or breastfeeding","locations":[{"facility":"University Clinical Trials","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Omega Research DeBary, LLC","city":"DeBary","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Boeson Research MSO","city":"Missoula","state":"Montana","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Director","phone":"1 617 885-8290","email":"medinfo@beelinemedicines.com"}],"primaryOutcomes":["Percent change from baseline in CLASI-A total score","Proportion of participants achieving a CLASI-70 response (≥70% decrease from baseline in CLASI-A total score)"],"hasResults":false,"conditionSlugs":["lupus"],"drugSlugs":[],"locationSlugs":["san-diego-california","debary-florida","missoula-montana"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Afimetoran for Cutaneous Lupus Erythematosus (CLE)","inPlainEnglish":"This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus, whose disease has not responded to or who cannot tolerate antimalarial therapy. Participants are assigned by chance to receive afimetoran or a matching dummy treatment (placebo) capsule once daily for 24 weeks, in addition to their existing standard lupus care.","whoItsFor":["Ages 16 Years to any","Adults aged ≥18 years (or ≥16 years where permitted)","Histologically confirmed active cutaneous lupus erythematosus (CLE) with or without systemic manifestations","Active subacute and/or chronic cutaneous lupus erythematosus, including discoid lupus erythematosus","Moderate to severe skin disease activity","Refractory, intolerant, or inadequately controlled on antimalarial therapy","Willing and able to comply with study requirements","Agreement to protocol-specified contraception requirements"],"whoShouldSkip":["Severe lupus nephritis or severe neuropsychiatric SLE","Active or chronic clinically significant infections, including HIV, hepatitis B, hepatitis C, active tuberculosis, untreated latent tuberculosis, or uncontrolled congestive heart failure","Significant concurrent autoimmune disease other than lupus-related conditions permitted by the protocol","Active malignancy or recent history of certain cancers","Other dermatologic conditions that may interfere with study assessments","Recent use of prohibited medications or investigational therapies","Prior treatment with afimetoran or another TLR7/TLR8 antagonist"],"whatHappens":"If you join, the listed intervention(s) are Afimetoran, or Placebo. The registry lists allocation as randomized. This study is evaluating whether afimetoran, an investigational oral medicine that blocks toll-like receptors 7 and 8 (TLR7/TLR8), can improve skin disease in adults with active cutaneous lupus erythematosus (CLE), with or without systemic lupus, whose disease has not responded to or who cannot tolerate antimalarial therapy.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 390 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.263Z"},{"nctId":"NCT07881458","title":"A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes","officialTitle":"A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity or Overweight and Type 2 Diabetes","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Eli Lilly and Company","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes.\n\nParticipation in the study will last about 2 years.","conditions":["Obesity","Overweight","Diabetes Mellitus, Type 2"],"keywords":[],"interventions":[{"type":"DRUG","name":"eloralintide and tirzepatide"},{"type":"DRUG","name":"Tirzepatide"}],"enrollment":1000,"startDate":"2026-10-16","completionDate":"2029-10","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have type 2 diabetes\n* Have a stable self-reported body weight (\\<5% body weight change) for 90 days prior to screening\n* Have a BMI of ≥27 kg/m2 at screening\n* Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight\n\nExclusion Criteria:\n\n* Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)\n* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity and/or type 2 diabetes (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)\n* Have type 1 diabetes\n* Have taken any of the following within 90 days prior to screening\n\n  * medications with direct amylin, glucagon-like peptide-1 (GLP-1) or glucagon-dependent insulinotropic polypeptide (GIP) receptor activity, including compounded therapies\n  * dipeptidyl peptidase 4 (DPP-4) inhibitors, and\n  * insulin\n* Have had within 90 days prior to screening:\n\n  * heart attack\n  * stroke\n  * coronary artery revascularization\n  * unstable angina, or\n  * hospitalization due to congestive heart failure\n* Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure\n* Have taken medications or alternative remedies intended for weight loss within 90 days of screening","locations":[{"facility":"Tucson Clinical Research Institute","city":"Tucson","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pacific Clinical Studies Inc.","city":"Los Alamitos","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Los Angeles Institute for Metabolic Research","city":"Los Angeles","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Colorado Anschutz Medical Campus","city":"Aurora","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"American Research Centers of Florida","city":"Pembroke Pines","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Encore Medical Research - Weston","city":"Weston","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Dalton - Clinical Trials Center by Walmart & Care Access","city":"Dalton","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pacific Diabetes & Endocrine Center","city":"Honolulu","state":"Hawaii","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research - Indianapolis","city":"Indianapolis","state":"Indiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Eunice","city":"Eunice","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tandem Clinical Research","city":"Marrero","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Care Access - St. Louis","city":"St Louis","state":"Missouri","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research Warren","city":"Warren Township","state":"New Jersey","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NYC Research","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research NYC Midtown","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research Austin","city":"Austin","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diabetes and Thyroid Center of Ft. Worth","city":"Fort Worth","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Juno Research","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Houston - Clinical Trials Center by Walmart & Care Access","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"ERA Health Research-Texas","city":"Midland","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Texas Valley Clinical Research (TVCR) - Mission","city":"Mission","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IMA Clinical Research San Antonio","city":"San Antonio","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Care Access - Tyler - Clinical Trials Center by Walmart & Care Access","city":"Tyler","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Washington Center for Weight Management and Research","city":"Arlington","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Eastside Research Associates","city":"Redmond","state":"Washington","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centro de Pesquisa Sao Lucas","city":"Campinas","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cline Research Center","city":"Curitiba","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Núcleo de Pesquisa Clínica do Rio Grande do Sul","city":"Porto Alegre","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IBPClin - Instituto Brasil de Pesquisa Clínica","city":"Rio de Janeiro","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CPCLIN","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CEPIC - Centro Paulista de Investigação Clínica","city":"São Paulo","state":"","country":"Brazil","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Jilin University","city":"Changchun","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital","city":"Jinan","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Henan University of Science &Technology","city":"Luoyang Shi","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanjing Medical University","city":"Nanjing","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo First Hospital","city":"Ningbo","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Hospital of Hebei Medical University","city":"Shijiazhuang","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Medical University Zhu Xianyi Memorial Hospital","city":"Tianjin","state":"","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"StudyPoint Duisburg","city":"Duisburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diabetes Zentrum Wilhelmsburg","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Institut für Diabetesforschung GmbH Münster","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Schwerpunktpraxis für Diabetes und Ernährungsmedizin Dr. med. Winfried Keuthage","city":"Münster","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"FutureMeds Offenbach","city":"Offenbach","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"RED-Institut GmbH","city":"Oldenburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Medical Corporation Chiseikai Tokyo Center Clinic","city":"Chūōku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tokyo Asbo Clinic","city":"Chūōku","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chiba Saiseikai Narashino hospital","city":"Narashino","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Soka Sugiura Internal Medicine Clinic","city":"Sōka","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Tsuchiura Beryl Clinic","city":"Tsuchiura","state":"","country":"Japan","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Latin Clinical Trial Center","city":"San Juan","state":"","country":"Puerto Rico","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CMI Cardiologie - Dr. Mercea Corina Delia","city":"Baia Mare","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"C.M.D.T.A. Neomed","city":"Brasov","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Geea Medical Easy Diet","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Centrul Medical NutriLife","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Futuremeds - București","city":"Bucharest","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Futuremeds - Craiova 2","city":"Craiova","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Futuremeds - Galați","city":"Galați","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Gama Diamed","city":"Mangalia","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Diabdana","city":"Oradea","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinica Korall","city":"Satu Mare","state":"","country":"Romania","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Korea University Ansan Hospital","city":"Ansan-si","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Chosun University Hospital","city":"Gwangju","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Seoul National University Bundang Hospital","city":"Seongnam","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Nowon Eulji Medical Center, Eulji University","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Severance Hospital, Yonsei University Health System","city":"Seoul","state":"","country":"South Korea","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"CHUAC-Complejo Hospitalario Universitario A Coruña","city":"A Coruña","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario de La Ribera","city":"Alzira","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Clínic de Barcelona","city":"Barcelona","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval","city":"Ferrol","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Vithas La Salud","city":"Granada","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"H.R.U Málaga - Hospital Civil","city":"Málaga","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitario Virgen Del Rocio","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Vithas Hospital Sevilla","city":"Seville","state":"","country":"Spain","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hsinchu Mackay Memorial Hospital","city":"Hsinchu","state":"","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or","phone":"317-615-4559","email":"LillyTrials@Lilly.com"},{"name":"Physicians interested in becoming principal investigators please contact","phone":"","email":"clinical_inquiry_hub@lilly.com"}],"primaryOutcomes":["Percent Change from Baseline in Body Weight"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["tirzepatide"],"locationSlugs":["tucson-arizona","los-alamitos-california","los-angeles-california","aurora-colorado","pembroke-pines-florida","weston-florida","dalton-georgia","honolulu-hawaii","indianapolis-indiana","eunice-louisiana","marrero-louisiana","st-louis-missouri","warren-township-new-jersey","new-york-new-york","austin-texas","fort-worth-texas","houston-texas","midland-texas","mission-texas","san-antonio-texas","tyler-texas","arlington-virginia","redmond-washington","campinas-brazil","curitiba-brazil","porto-alegre-brazil","rio-de-janeiro-brazil","s-o-paulo-brazil","changchun-china","jinan-china","luoyang-shi-china","nanjing-china","ningbo-china","shijiazhuang-china","tianjin-china","duisburg-germany","hamburg-germany","m-nster-germany","offenbach-germany","oldenburg-germany","ch-ku-japan","narashino-japan","s-ka-japan","tsuchiura-japan","san-juan-puerto-rico","baia-mare-romania","brasov-romania","bucharest-romania","craiova-romania","gala-i-romania","mangalia-romania","oradea-romania","satu-mare-romania","ansan-si-south-korea","gwangju-south-korea","seongnam-south-korea","seoul-south-korea","a-coru-a-spain","alzira-spain","barcelona-spain","ferrol-spain","granada-spain","m-laga-spain","seville-spain","hsinchu-taiwan"],"enrichment":{"headline":"Phase 3: testing eloralintide and tirzepatide for Obesity","inPlainEnglish":"This study wants to investigate the how well it works and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 2 years.","whoItsFor":["Ages 18 Years to any","Have type 2 diabetes","Have a stable self-reported body weight (\\<5% body weight change) for 90 days prior to screening","Have a body-mass index (BMI) of ≥27 kg/m2 at screening","Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight"],"whoShouldSkip":["Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed \\>1 year before screening)","Have a prior or planned endoscopic procedure and/or device-based therapy for obesity and/or type 2 diabetes (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)","Have type 1 diabetes","Have taken any of the following within 90 days prior to screening","medications with direct amylin, glucagon-like peptide-1 (GLP-1) or glucagon-dependent insulinotropic polypeptide (GIP) receptor activity, including compounded therapies","dipeptidyl peptidase 4 (DPP-4) inhibitors, and","Have had within 90 days prior to screening:"],"whatHappens":"If you join, the listed intervention(s) are eloralintide and tirzepatide, or Tirzepatide. The registry lists allocation as randomized. This study wants to investigate the how well it works and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 1,000 people at 75 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:21.021Z"},{"nctId":"NCT07881757","title":"A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH OBSTRUCTIVE SLEEP APNEA AND OVERWEIGHT OR OBESITY NOT RECEIVING POSITIVE AIRWAY PRESSURE THERAPY (VESPER-OSA 2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \\[OSA\\]) and overweight or obesity who are not using a breathing machine (positive airway pressure \\[PAP\\] machine).\n\nPeople may be able to take part if they are adults with moderate to severe OSA, have overweight or obesity, and have been unable or unwilling using PAP therapy before joining the study. Participants will be assigned by chance to receive either berobenatide or a placebo (a treatment that looks like the study medicine but contains no active medicine). The study treatment will be given as an injection under the skin approximately once a month. Participants will receive study treatment at study sites and may administer some doses at home after receiving training.\n\nDuring the study, participants will attend study visits, undergo sleep studies, complete questionnaires, and have health assessments performed. Researchers will compare the effects of berobenatide and placebo on sleep apnea, body weight, and other health measures.","conditions":["Apnea","Sleep Disorders","Overweight and/or Obesity"],"keywords":["Obstructive Sleep Apnea","OSA","Sleep Apnea","Breathing Disorder","Snoring","Daytime Sleepiness","Excessive Daytime Sleepiness","Breathing Stops During Sleep","Sleep Problems","Sleep Disorder","Sleep Study","Polysomnography","PSG"],"interventions":[{"type":"DRUG","name":"Berobenatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":258,"startDate":"2026-10-19","completionDate":"2028-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Body mass index (BMI) ≥27 kg/m² at screening\n* Previously diagnosed with moderate to severe obstructive sleep apnea (OSA)\n* Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening\n\nExclusion Criteria:\n\n* Self-reported body weight change of more than 5% within 90 days prior to screening\n* Diagnosis of any type of diabetes (resolved gestational diabetes is permitted)\n* History of acute or chronic pancreatitis\n* Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2) Sleep-disordered breathing conditions other than obstructive sleep apnea that could interfere with study assessments or interpretation of results (eg, central sleep apnea, mixed sleep apnea, Cheyne-Stokes respiration, obesity hypoventilation syndrome, or significant craniofacial abnormalities).","locations":[{"facility":"Cullman Clinical Trials","city":"Cullman","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research-Bradenton","city":"Bradenton","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research - Twin Cities","city":"Maplewood","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research-Tomball","city":"Tomball","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change From Baseline in Apnea-Hypopnea Index"],"hasResults":false,"conditionSlugs":["obesity","sleep-apnea"],"drugSlugs":[],"locationSlugs":["cullman-alabama","bradenton-florida","maplewood-minnesota","tomball-texas"],"enrichment":{"headline":"Phase 3: testing Berobenatide for Apnea","inPlainEnglish":"This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide). The study will see if berobenatide can help adults with breathing problems during sleep (obstructive sleep apnea \\[OSA\\]) and overweight or obesity who are not using a breathing machine (positive airway pressure \\[PAP\\] machine).","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Body mass index (body-mass index (BMI)) ≥27 kg/m² at screening","Previously diagnosed with moderate to severe obstructive sleep apnea (OSA)","Unable or unwilling to use positive airway pressure (PAP) therapy, and no use of PAP therapy for at least 4 weeks prior to screening"],"whoShouldSkip":["Self-reported body weight change of more than 5% within 90 days prior to screening","Diagnosis of any type of diabetes (resolved gestational diabetes is permitted)","History of acute or chronic pancreatitis"],"whatHappens":"If you join, the listed intervention(s) are Berobenatide, or Placebo. The registry lists allocation as randomized. This study is being done to learn about the safety and effects of a study medicine called berobenatide (bear-oh-BEN-uh-tide).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 258 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.938Z"},{"nctId":"NCT07882316","title":"Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty","officialTitle":"Effect of Preoperative Multimorbidity Burden on the Trajectory of Functional Recovery After Primary Total Knee Arthroplasty: A Single-Center Prospective Observational Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Balikesir Ataturk City Hospital","sponsorClass":"OTHER_GOV","summary":"This prospective observational cohort study aims to investigate the association between preoperative multimorbidity burden and functional recovery after primary total knee arthroplasty (TKA) in patients with knee osteoarthritis.\n\nApproximately 230 adult patients undergoing elective unilateral primary TKA will be enrolled at a single hospital in Türkiye. Preoperative multimorbidity burden will be assessed using the Functional Comorbidity Index (FCI), which measures the presence of medical conditions that may affect physical function.\n\nPatients will be evaluated before surgery and at 6 and 12 months after surgery. Functional outcomes and pain will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Oxford Knee Score (OKS). Anxiety and depressive symptoms will be evaluated using the Hospital Anxiety and Depression Scale (HADS).\n\nThe primary objective is to determine whether higher preoperative multimorbidity burden is associated with poorer physical function at 12 months after TKA. The study will also examine changes in functional recovery over time and other clinical outcomes.\n\nAll surgical procedures, postoperative care, and rehabilitation will follow routine clinical practice. No additional treatment or experimental intervention will be assigned as part of this study.","conditions":["Knee Osteoarthritis","Multimorbidity"],"keywords":["Total Knee Arthroplasty","Functional Comorbidity Index","Functional Recovery","Patient-Reported Outcome Measures"],"interventions":[],"enrollment":230,"startDate":"2026-06-26","completionDate":"2028-08","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Scheduled for elective unilateral primary total knee arthroplasty due to primary knee osteoarthritis.\n* Sufficient cognitive and communication abilities to understand and complete the study questionnaires.\n* Provision of written informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients scheduled for revision total knee arthroplasty.\n* Patients scheduled for simultaneous bilateral total knee arthroplasty.\n* Arthroplasty indicated for inflammatory arthritis, tumor, infection, or post-traumatic conditions.\n* Severe cognitive impairment, advanced dementia, or communication difficulties preventing valid completion of the study questionnaires.\n* Significant logistical or legal circumstances preventing completion of the planned follow-up assessments.","locations":[{"facility":"Güneş Sarikaya","city":"Balıkesir","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Güneş SARIKAYA","phone":"05436733113","email":"gunessarikaya05@hotmail.com"}],"primaryOutcomes":["WOMAC Physical Function Subscale Score at 12 Months"],"hasResults":false,"conditionSlugs":["als","depression","osteoarthritis"],"drugSlugs":[],"locationSlugs":["bal-kesir-turkey-t-rkiye"],"enrichment":{"headline":"Preoperative Multimorbidity and Functional Recovery After Total Knee Arthroplasty","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) cohort study aims to investigate the association between preoperative multimorbidity burden and functional recovery after primary total knee arthroplasty (TKA) in patients with knee osteoarthritis. Approximately 230 adult patients undergoing elective unilateral primary TKA will be enrolled at a single hospital in Türkiye.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Scheduled for elective unilateral primary total knee arthroplasty due to primary knee osteoarthritis","Sufficient cognitive and communication abilities to understand and complete the study questionnaires"],"whoShouldSkip":["Patients scheduled for revision total knee arthroplasty","Patients scheduled for simultaneous bilateral total knee arthroplasty","Arthroplasty indicated for inflammatory arthritis, tumor, infection, or post-traumatic conditions","Severe cognitive impairment, advanced dementia, or communication difficulties preventing valid completion of the study questionnaires","Significant logistical or legal circumstances preventing completion of the planned follow-up assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 230 people at Balıkesir. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.516Z"},{"nctId":"NCT07882498","title":"Postoperative Pain Trajectories After Endometriosis Surgery","officialTitle":"Pain Trajectories After Surgery for Endometriosis: A 6-Month Prospective Monocentric Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre Hospitalier Universitaire, Amiens","sponsorClass":"OTHER","summary":"The pain associated with endometriosis reflects a multifactorial pathophysiology combining peripheral nociception, central sensitisation and psychosocial factors. Although surgery is an integral part of treatment, a significant proportion of patients experience persistent pain several months after the procedure. To date, postoperative pain trajectories after endometriosis surgery remain poorly characterised, and there are no reliable predictors of chronic postoperative pain (CPP). This prospective, single-centre, longitudinal study aims to identify distinct postoperative pain trajectories and to assess whether perioperative quantitative sensory testing can predict the development of chronic postoperative pain at 3 and 6 months. Patients will undergo perioperative mechanical and pressure tests, including assessment of temporal summation and pressure pain thresholds, combined with validated measures of patient- reported outcomes. Follow-up assessments will be conducted on day 2, day 14, 1 month, 3 months, and 6 months after surgery to capture the dynamic evolution of pain, quality of life, fatigue, sexual function, and central sensitisation symptoms.","conditions":["Endometriosis","Postoperative Pain","Pain Trajectories","Chronic Postsurgical Pain","Quantitative Sensory Testing","Central Sensitization"],"keywords":["Endometriosis","Postoperative pain","Pain trajectories","Chronic postsurgical pain","Quantitative sensory testing","Central sensitization"],"interventions":[{"type":"OTHER","name":"Perioperative quantitative sensory testing"},{"type":"OTHER","name":"questionnaire"}],"enrollment":150,"startDate":"2026-07-07","completionDate":"2028-07","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Imaging-confirmed endometriosis\n* Scheduled surgical treatment for endometriosis\n* Affiliation to the French Social Security system\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Patients under legal protection (guardians or curators)\n* History of psychiatric disorders\n* Neurodegenerative diseases\n* Inability to self-assess pain using a numerical rating scale\n* Non-French-speaking patients\n* Pregnancy or breastfeeding\n* Refusal to participate","locations":[{"facility":"CHU Amiens-Picardie","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paul Tarpin","phone":"33+3.22.08.79.80","email":"Tarpin.paul@chu-amiens.fr"}],"primaryOutcomes":["Brief Pain Inventory values for pain intensity and interference measurement","EHP-5 values for quality of life measurement","EHP-5 values for quality of life measurement","FSFI values for sexual function measurement","FSFI values for sexual function measurement","Brief Pain Inventory values for pain intensity and interference measurements","PROMIS Fatigue SF-6a values for fatigue measurement","PROMIS Fatigue SF-6a values for fatigue measurement","Convergences PP values for central sensitization symptoms measurement","Convergences PP values for central sensitization symptoms measurement"],"hasResults":false,"conditionSlugs":["endometriosis"],"drugSlugs":[],"locationSlugs":["amiens-france"],"enrichment":{"headline":"Not a traditional drug phase: Perioperative quantitative sensory testing for Endometriosis","inPlainEnglish":"The pain associated with endometriosis reflects a multifactorial pathophysiology combining peripheral nociception, central sensitisation and psychosocial factors. Although surgery is an integral part of treatment, a significant proportion of patients experience persistent pain several months after the procedure.","whoItsFor":["Ages 18 Years to any","Women only","Imaging-confirmed endometriosis","Scheduled surgical treatment for endometriosis","Affiliation to the French Social Security system"],"whoShouldSkip":["Patients under legal protection (guardians or curators)","History of psychiatric disorders","Neurodegenerative diseases","Inability to self-assess pain using a numerical rating scale","Non-French-speaking patients","Pregnancy or breastfeeding","Refusal to participate"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Amiens. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.110Z"},{"nctId":"NCT07883824","title":"Aquatic Exercise in Patients With Knee Osteoarthritis","officialTitle":"The Effect of Aquatic Exercise on Central Sensitization and Functional Parameters in Patients With Knee Osteoarthritis: a Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Kirsehir Ahi Evran Universitesi","sponsorClass":"OTHER","summary":"The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.","conditions":["Central Sensitization","Knee Osteoarthristis","Aquatic"],"keywords":["balance","quality of life","depression","central sensitization","knee osteoarthritis","aquatic exercise"],"interventions":[{"type":"OTHER","name":"Standard physical therapy"},{"type":"OTHER","name":"Hydrotherapy"}],"enrollment":60,"startDate":"2026-06-01","completionDate":"2026-12-01","sex":"ALL","minAge":"40 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 40-65\n2. Individuals diagnosed with knee osteoarthritis\n3. Individuals with no cognitive impairments\n4. Volunteers for the study\n\nExclusion Criteria:\n\n1. Individuals who have undergone knee surgery\n2. Individuals presenting with signs such as fracture, malignancy, or infection\n3. Pregnancy\n4. Individuals with cognitive impairments who are unable to express themselves.","locations":[{"facility":"Kirsehir Ahi Evran University, Kırşehir, Merkez 40100","city":"Kırşehir","state":"Merkez","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mensure Aslan","phone":"90 386 280 50 31","email":"mensure.aa@outlook.com"}],"primaryOutcomes":["Central Sensitization"],"hasResults":false,"conditionSlugs":["depression","osteoarthritis"],"drugSlugs":[],"locationSlugs":["k-r-ehir-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Standard physical therapy for Central Sensitization","inPlainEnglish":"The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date. The aim of this study is to examine the effect of aquatic exercise on central sensitization and functional parameters in patients with knee osteoarthritis.","whoItsFor":["Ages 40 Years to 65 Years","Individuals diagnosed with knee osteoarthritis","Individuals with no cognitive impairments","Volunteers for the study"],"whoShouldSkip":["Individuals who have undergone knee surgery","Individuals presenting with signs such as fracture, malignancy, or infection","Individuals with cognitive impairments who are unable to express themselves"],"whatHappens":"If you join, the listed intervention(s) are Standard physical therapy, or Hydrotherapy. The registry lists allocation as randomized. The effect of aquatic exercise on central sensitization in patients with knee osteoarthritis are not fully known in the studies conducted to date.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Kırşehir. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.521Z"},{"nctId":"NCT07885423","title":"68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer","officialTitle":"Clinical Evaluation of the ACP3-Targeted Dual-Modality PET/Fluorescence Imaging Probe 68Ga-XMFH01 for Preoperative Imaging and Intraoperative Surgical Guidance in Prostate Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The First Affiliated Hospital of Xiamen University","sponsorClass":"OTHER","summary":"This study aims to evaluate the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.","conditions":["Prostate Cancer (Diagnosis)","ACP3","PET / CT"],"keywords":["Prostate Cancer","ACP3","PET/CT"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"68Ga-XMFH01 PET/CT"}],"enrollment":25,"startDate":"2026-10-21","completionDate":"2027-09-30","sex":"MALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients diagnosed with prostate cancer who are scheduled to undergo surgical treatment;\n* Adult patients (aged 18 years or older);\n* No evidence of distant metastases (M0), including nonregional lymph node metastases, bone metastases, or visceral metastases, as determined by conventional imaging (bone scintigraphy, CT, or MRI) or PET/CT;\n* Patients with regional pelvic lymph node metastases (N1) are eligible for inclusion;\n* Patients who have been fully informed of their disease status, treatment options, and study procedures, and who voluntarily provide written informed consent;\n* Patients who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations.\n\nExclusion Criteria:\n\n* Patients who are unwilling or unable to provide written informed consent or cooperate with study procedures;\n* Patients who are unable to tolerate PET/CT examinations;\n* Patients who have previously received any of the following treatments for prostate cancer: (a) Systemic therapy: More than 2 months of androgen deprivation therapy (ADT) or conventional hormonal therapy, or any prior treatment with novel hormonal agents, chemotherapy, immunotherapy, or targeted therapy. (b) Local therapy: Prior pelvic radiotherapy or surgery for prostate cancer;\n* Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.","locations":[{"facility":"The First Affiliated Hospital of Xiamen University","city":"Xiamen","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liang Zhao, MD","phone":"18818350620","email":"wzhaoliang01@163.com"},{"name":"Haojun Chen, MD, PhD","phone":"86 18659285282","email":"leochen0821@foxmail.com"}],"primaryOutcomes":["Diagnostic efficacy"],"hasResults":false,"conditionSlugs":["prostate-cancer"],"drugSlugs":[],"locationSlugs":["xiamen-china"],"enrichment":{"headline":"Not a traditional drug phase: 68Ga-XMFH01 PET/CT for Prostate Cancer (Diagnosis)","inPlainEnglish":"This study aims to measure the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.","whoItsFor":["Ages 18 Years to any","Men only","Patients diagnosed with prostate cancer who are scheduled to undergo surgical treatment;","Adult patients (aged 18 years or older);","No evidence of distant metastases (M0), including nonregional lymph node metastases, bone metastases, or visceral metastases, as determined by conventional imaging (bone scintigraphy, CT, or MRI) or PET/CT;","Patients with regional pelvic lymph node metastases (N1) are eligible for inclusion;","Patients who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations"],"whoShouldSkip":["Patients who are unable to tolerate PET/CT examinations;","Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer"],"whatHappens":"If you join, the listed intervention(s) are 68Ga-XMFH01 PET/CT. The registry lists allocation as na. This study aims to measure the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 25 people at Xiamen. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:03.316Z"},{"nctId":"NCT07886879","title":"Parkinson's Disease in Type 1 Gaucher Disease","officialTitle":"Comprehensive Phenotyping of Type 1 Gaucher Disease Patients for Prodromal Parkinson's Disease: A Behavioral and Biomarker Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"Parkinson's disease (PD) is an age-related movement disorder with a complex pathophysiology. Among the risk factors for PD, variants in beta-glucocerebrosidase (encoded by the gene GBA1) represent one of the most significant heritable risk factors for lifetime PD risk. Biallelic variants in GBA1 cause Gaucher disease (GD), a multisystem disorder, and individuals with late/adult-onset GD1 have a \\~1-in-9 lifetime risk for PD. This study aims to develop a cross-sectional cohort of clinical and laboratory phenotyped adult GD1 patients and controls for investigation of clinical/laboratory risk factors for current and future Parkinson risk. Neurological evaluations will be video and audio recorded to allow the investigators to quantify neurological function using automated tools. Data and specimens generated in this study will be incorporated into a de-identified biobank that will be used for further research into GD and PD.","conditions":["Parkinson Disease (PD)","Type 1 Gaucher Disease"],"keywords":["Parkinson's Disease","Gaucher Disease","Deep Phenotyping","GBA1"],"interventions":[],"enrollment":100,"startDate":"2026-09-21","completionDate":"2028-03","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects with a documentation of GBA1 phenotype\n* Subjects older than 40 years old\n* Either GD1 participants with or without PD\n* GBA1 heterozygotes with or without PD\n* Non-carrier controls without neurological disorder and no first-degree family relative with PD\n\nExclusion Criteria:\n\n• Subjects with diminished mental capacity and unable to consent for themselves","locations":[{"facility":"Icahn School of Medicine at Mount Sinai","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Drew Sinha, MD PhD","phone":"646-761-7891","email":"drew.sinha@mssm.edu"},{"name":"Rewaa Elgazzar, B.S.","phone":"646-761-7891","email":"rewaa.elgazzar@mssm.edu"}],"primaryOutcomes":["Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II, and IV","REM Behavioral Disorder Screening Questionnaire (RBDSQ)","Montreal Cognitive Assessment (MoCA)","Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT)","University of Pennsylvania Smell Identification Test (UPSIT)","Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Parkinson's Disease in Type 1 Gaucher Disease","inPlainEnglish":"Parkinson's disease (PD) is an age-related movement disorder with a complex pathophysiology. Among the risk factors for PD, variants in beta-glucocerebrosidase (encoded by the gene GBA1) represent one of the most significant heritable risk factors for lifetime PD risk.","whoItsFor":["Ages 40 Years to any","Subjects with a documentation of GBA1 phenotype","Subjects older than 40 years old","Either GD1 participants with or without PD","GBA1 heterozygotes with or without PD","Non-carrier controls without neurological disorder and no first-degree family relative with PD"],"whoShouldSkip":["Subjects with diminished mental capacity and unable to consent for themselves"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at New York. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.669Z"},{"nctId":"NCT07889154","title":"Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea","officialTitle":"The Effects of Physical Activity Habits on Sleep Quality and Respiratory Parameters in Individuals With Obstructive Sleep Apnea","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Medipol University","sponsorClass":"OTHER","summary":"Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited. This study aims to investigate these associations in individuals with OSA.","conditions":["Obstructive Sleep Apnea","Sleep Quality","Respiratory Function"],"keywords":["Obstructive Sleep Apnea","Physical Activity Habits","Sleep Health"],"interventions":[{"type":"BEHAVIORAL","name":"Physical Activity Education"}],"enrollment":48,"startDate":"2026-10-23","completionDate":"2027-06-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals diagnosed with mild to severe obstructive sleep apnea (OSA) based on laboratory polysomnography (AHI: 5-30 events/hour).\n* Individuals diagnosed by a pulmonologist within the past year who initiated CPAP therapy no more than 12 months ago and demonstrate regular use.\n* Individuals with habitual snoring.\n* Individuals who have not participated in OSA-focused physiotherapy interventions within the past 3 months.\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\>40 kg/m².\n* Severe substance or alcohol dependence.\n* Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns.\n* Pregnancy or postpartum period (\\<6 months).\n* Medical contraindications to physical activity according to American College of Sports Medicine (ACSM) guidelines, such as unstable coronary artery disease or decompensated heart failure.\n* History of stroke or significant respiratory, neuromuscular, inflammatory, or other disorders causing hypercapnia.\n* Craniofacial abnormalities, severe upper airway obstruction, or secondary respiratory diseases such as chronic obstructive pulmonary disease (COPD).","locations":[{"facility":"Istanbul Medipol Universty","city":"Istanbul","state":"Göztepe","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gülay Aras Bayram, PhD","phone":"+905054966284","email":"garas@medipol.edu.tr"},{"name":"Devrim Tarakci, PhD","phone":"+905322052282","email":"dtarakci@medipol.edu.tr"}],"primaryOutcomes":["Pittsburgh Sleep Quality Index (PSQI)","Average Nightly CPAP Usage","Average CPAP Mask Leak","Average CPAP Treatment Pressure","MIP-MEP measurement","Forced Vital Capacity (FVC) measurement","FEV₁ (Forced Expiratory Volume in 1 Second)","FEV1/FVC ratio","FEF 25%-75% (Maximal Mid-Expiratory Flow Rate","Baecke Habitual Physical Activity Questionnaire (BHPAQ)"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Physical Activity Education for Obstructive Sleep Apnea","inPlainEnglish":"Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited. This study aims to investigate these associations in individuals with OSA.","whoItsFor":["Ages 18 Years to 65 Years","Individuals diagnosed with mild to severe obstructive sleep apnea (OSA) based on laboratory polysomnography (AHI: 5-30 events/hour)","Individuals diagnosed by a pulmonologist within the past year who initiated CPAP therapy no more than 12 months ago and demonstrate regular use","Individuals with habitual snoring","Individuals who have not participated in OSA-focused physiotherapy interventions within the past 3 months"],"whoShouldSkip":["Body mass index (body-mass index (BMI)) \\>40 kg/m²","Severe substance or alcohol dependence","Regular use of sedatives, muscle relaxants, or opioids that may affect sleep patterns","Pregnancy or postpartum period (\\<6 months)","Medical contraindications to physical activity according to American College of Sports Medicine (ACSM) guidelines, such as unstable coronary artery disease or decompensated heart failure","History of stroke or significant respiratory, neuromuscular, inflammatory, or other disorders causing hypercapnia","Craniofacial abnormalities, severe upper airway obstruction, or secondary respiratory diseases such as chronic obstructive pulmonary disease (COPD)"],"whatHappens":"If you join, the listed intervention(s) are Physical Activity Education. The registry lists allocation as randomized. Although exercise and physical activity have shown beneficial effects in individuals with obstructive sleep apnea (OSA), evidence regarding the effects of daily physical activity habits on sleep quality and respiratory parameters remains limited.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 48 people at Istanbul. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.944Z"},{"nctId":"NCT07890337","title":"Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)","officialTitle":"Rehabilitation Through Virtual Immersion & Integrated Exposure for Mild Traumatic Brain Injury (ReVIVE for mTBI)","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The primary goal of this study is to evaluate the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI. Specifically, the study will: Evaluate PTSD Symptom Reduction - PTSD symptoms, specifically hyperarousal and hypervigilance will be assessed using the Davidson Trauma Scale, which will provide insight into improvements PTSD symptom reduction.","conditions":["Traumatic Brain Injuries","TBI (Traumatic Brain Injury)","MTBI - Mild Traumatic Brain Injury","mTBI","Traumatic Brain Injury | Patient","Traumatic Brain Injury and Co-occurring Disorders","PTSD - Post Traumatic Stress Disorder"],"keywords":["traumatic brain injury","post traumatic stress disorder","digital therapeutics","virtual reality"],"interventions":[{"type":"DEVICE","name":"Virtual Reality"},{"type":"BEHAVIORAL","name":"Standard Psychotherapy"}],"enrollment":30,"startDate":"2026-10","completionDate":"2027-05","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n* History of one or more concussions.\n* Presence of mild-to-moderate PTSD symptoms, defined as a score between 20 and 44 on the Davidson Trauma Scale (DTS), indicating clinically relevant but not severe symptomatology (Davidson et al., 1997).\n* Prior or ongoing therapy, defined as current or recent (within the last 3 months) engagement in standard care treatments such as psychiatric medication management, and evidence-based psychotherapy targeting mTBI or PTSD symptoms.\n* Prior U.S military service (any duration and any branch) is required for eligibility.\n\nExclusion criteria:\n\n* Age over 55 to reduce confounding effects of age-related neurodegeneration and cognitive decline.\n* Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).\n* Active substance abuse.\n* Presence of unrelated neurological conditions such as epilepsy, stroke, seizure disorders, or neurodegenerative diseases (e.g., Alzheimer's, Parkinson's).\n* Significant cognitive impairment, assessed by standardized cognitive screening, which would interfere with the ability to participate fully in VR and therapy sessions.\n* Physical impairments that would prevent safe engagement in VR and therapy.","locations":[{"facility":"Johns Hopkins Bayview Medical Center - Pyschiatry","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Saumik Das","phone":"703-554-0332","email":"sdas41@jh.edu"},{"name":"Durga Roy, MD","phone":"443-422-3506","email":""}],"primaryOutcomes":["Change in PTSD Symptom Severity Measured by the Davidson Trauma Scale (DTS)"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1: Virtual Reality for Traumatic Brain Injuries","inPlainEnglish":"The primary goal of this study is to measure the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI. Specifically, the study will: Evaluate PTSD Symptom Reduction - PTSD symptoms, specifically hyperarousal and hypervigilance will be assessed using the Davidson Trauma Scale, which will provide insight into improvements PTSD symptom reduction.","whoItsFor":["Ages 18 Years to 55 Years","History of one or more concussions","Presence of mild-to-moderate PTSD symptoms, defined as a score between 20 and 44 on the Davidson Trauma Scale (DTS), indicating clinically relevant but not severe symptomatology (Davidson et al., 1997)","Prior or ongoing therapy, defined as current or recent (within the last 3 months) engagement in standard care treatments such as psychiatric medication management, and evidence-based psychotherapy targeting mTBI or PTSD symptoms","Prior U.S military service (any duration and any branch) is required for eligibility"],"whoShouldSkip":["Age over 55 to reduce confounding effects of age-related neurodegeneration and cognitive decline","Diagnosis of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder)","Active substance abuse","Presence of unrelated neurological conditions such as epilepsy, stroke, seizure disorders, or neurodegenerative diseases (e.g., Alzheimer's, Parkinson's)","Significant cognitive impairment, assessed by standardized cognitive screening, which would interfere with the ability to participate fully in VR and therapy sessions","Physical impairments that would prevent safe engagement in VR and therapy"],"whatHappens":"If you join, the listed intervention(s) are Virtual Reality, or Standard Psychotherapy. The registry lists allocation as randomized. The primary goal of this study is to measure the effectiveness of an integrated therapeutic model - combining VR and standard psychotherapy in improving executive function and hyperarousal adults impacted with mTBI.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at Baltimore. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.413Z"},{"nctId":"NCT07891156","title":"Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.","officialTitle":"Changes to Body Composition With Semaglutide vs. Placebo in Adults With Type 1 Diabetes and Overweight/Obesity: a Double-blinded, Randomized, Parallel Controlled Trial","status":"RECRUITING","phases":["PHASE2","PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"McGill University Health Centre/Research Institute of the McGill University Health Centre","sponsorClass":"OTHER","summary":"The goal of this 24 week double-blinded, randomized, parallel controlled clinical trial is to learn how semaglutide affects body composition in adults with type 1 diabetes and overweight/obesity.\n\nThe main question to answer is:\n\nWhat effect does Semaglutide have on body composition in adults with type 1 diabetes and overweight/obesity compared to a placebo?\n\nAround 40 participants will:\n\n* Be randomly assigned to receive semaglutide or a placebo.\n* Self-administer the treatment drug once per week for 24 weeks.\n* Complete a series of tests, measurements and questionnaires throughout the study duration.\n* Attend a remote follow-up visit 4 weeks after the treatment is complete.","conditions":["Type 1 Diabetes","Overweight , Obesity"],"keywords":["Randomized","Double-blinded","Parallel controlled","semaglutide"],"interventions":[{"type":"DRUG","name":"Semaglutide"},{"type":"DRUG","name":"Placebo"}],"enrollment":40,"startDate":"2026-10-13","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-65 years old\n* Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement.\n* BMI (Body mass index) ≥ 27 kg/m2\n* Use of multi-daily injections or insulin pump therapy.\n* Use of CGM (continuous glucose monitoring).\n* Agreement to the use of a highly effective method of birth control in persons of child-bearing age (if sexually active) and active avoidance of pregnancy during the trial. Child-bearing potential refers to participants of the female sex post-menarche who have not reached menopause or have a disclosed medical condition causing sterility (e.g. hysterectomy). Post-menopausal state refers to the absence of menses for 12 months without any alternative cause.\n* Diabetic retinopathy assessment performed within the last 2 years, as per participant history.\n\nExclusion Criteria:\n\n* Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes.\n* Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months.\n\n\\*If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required\\*\n\n* HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months.\n* Current use of non-insulin anti-hyperglycemic agents within the last month.\n* Severe hypoglycemic episode within the last 3 months, defined as an event where glycemia was \\< 4 mmol/L, resulting in seizure, loss of consciousness, or need for third-party assistance in treatment.\n* Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous insulin due to ketones)\n* History of bariatric surgery\n* Personal history of acute/chronic pancreatitis or gallstone disease without cholecystectomy.\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.\n* Severe impairment of renal function with eGFR \\<30 mL/min/1.73 m2 (using CKD-EPI formula), measured within the last 12 months.\n* Use of supraphysiological doses of glucocorticoids in the last 3 months, and/or expected use at some point in the next 6 months.\n* Planned or ongoing pregnancy\n* Breastfeeding individuals\n* Prior hypersensitivity reaction to GLP1-RA (glucagon-like-peptide-1 receptor agonist)\n* Clinically significant gastroparesis, defined as persistent symptoms despite pharmacotherapy such as domperidone.\n* Any prior diagnostic history of eating disorder or suicidal attempts, or feelings of suicidal thoughts or behaviours in the last month\\*\\*\n* Unstable angina, or myocardial infarction/ cardiovascular surgery / coronary stenting in the last month.\n* Any serious medical or psychiatric illness likely to interfere with study participation as per the judgment of the investigator (e.g. cirrhosis, active cancer, decompensated schizophrenia).","locations":[{"facility":"Research Institute of the McGill University Health Centre Royal Victoria Hospital","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jakob Lenabat","phone":"438 822 3302","email":"Jakob.Lenabat-persson@mail.mcgill.ca"}],"primaryOutcomes":["Change in lean mass"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide"],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Phase 2 / Phase 3: testing Semaglutide for Type 1 Diabetes","inPlainEnglish":"The goal of this 24 week double-blinded, randomly assigned, parallel controlled clinical trial is to learn how semaglutide affects body composition in adults with type 1 diabetes and overweight/obesity. The main question to answer is: What effect does Semaglutide have on body composition in adults with type 1 diabetes and overweight/obesity compared to a dummy treatment (placebo)?","whoItsFor":["Ages 18 Years to 65 Years","Age 18-65 years old","Clinical diagnosis of T1D (type 1 diabetes) for ≥ 1 year, as per clinician judgement","body-mass index (BMI) (Body mass index) ≥ 27 kg/m2","Use of multi-daily injections or insulin pump therapy","Use of CGM (continuous glucose monitoring)","Diabetic retinopathy assessment performed within the last 2 years, as per participant history"],"whoShouldSkip":["Pre-existing conditions limiting physical activity, specifically inability to walk for 6 minutes","Active proliferative diabetic retinopathy requiring surgery or laser/injectable therapy within the last 3 months","\\*If a history of proliferative retinopathy is present within the last year, written permission from the eligible participant's ophthalmologist or optometrist is required\\*","HbA1c (glycated hemoglobin) ≥ 10% within the last 3 months","Current use of non-insulin anti-hyperglycemic agents within the last month","Severe hypoglycemic episode within the last 3 months, defined as an event where glycemia was \\< 4 mmol/L, resulting in seizure, loss of consciousness, or need for third-party assistance in treatment","Diabetic ketoacidosis (DKA) within the last 3 months (DKA refers to the need to present to medical attention and the requirement of intravenous insulin due to ketones)"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide, or Placebo. The registry lists allocation as randomized. The goal of this 24 week double-blinded, randomly assigned, parallel controlled clinical trial is to learn how semaglutide affects body composition in adults with type 1 diabetes and overweight/obesity.","phaseExplainer":"Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.","effort":"They plan to enroll about 40 people at Montreal. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.727Z"},{"nctId":"NCT07891624","title":"Neural Mechanisms of Real-world Emotions and Internalizing","officialTitle":"Using High-stakes, Real-world Events to Map the Neural Dynamics Linked to Internalizing Disorders","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Miami","sponsorClass":"OTHER","summary":"This study utilizes mobile health methods, including smartphone technology, subjective self-reports measures of emotion, behavioral tasks, functional Magnetic Resonance Imaging (fMRI), physiological measures of attention and arousal, and measures of health and social support to identify neural mechanisms associated with individual differences in the temporal course of emotional responses. The aim of this project is to utilize real-world and personally relevant events as stimuli to better understand how the temporal course of emotional responses relate to risk for developing mental disorders.","conditions":["Major Depression","Generalized Anxiety","Emotions"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"Academic Performance Feedback"}],"enrollment":144,"startDate":"2026-08-24","completionDate":"2030-11-30","sex":"ALL","minAge":"18 Years","maxAge":"35 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals who are between 18 - 35 years old. \\[Reason: to be able to provide informed consent, and to minimize variation in functional and structural differences in brain\\]\n* Individuals who are fluent English speakers. \\[Reason: to understand study instructions \\& questionnaires\\]\n* Smart phone access. \\[Reason: to answer the questionnaires that are administered throughout the study.\n\nExclusion Criteria:\n\n* Women who are pregnant or breast feeding and are no more than six months post-partum. \\[Reason: may be unsafe for fetus, may affect outcome measure(s)\\]\n* Individuals who are excluded based on attached metal resonance Screening Form (Note: this form has already been approved by the Institutional Review Board (IRB for other protocols). \\[Reason: necessary to participate in MRI research protocol\\]\n* Individuals whose BMI is above 35. \\[Reason: must fit into fMRI scanner\\]\n* Individuals who have claustrophobia. \\[Reason: to be able to stay in MRI scanner\\]\n* Individuals who are unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial. \\[Reason: to be able to understand instructions and ensure safety\\]\n* Individuals who are unable to safely undergo MRI scanning. \\[Reason: to be able to undergo MRI scanning\\]","locations":[{"facility":"University of Miami","city":"Coral Gables","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aaron S Heller, PhD","phone":"305-284-9498","email":"axh825@miami.edu"}],"primaryOutcomes":["Mean Duration of fMRI-Derived Negative Emotional Brain States"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["coral-gables-florida"],"enrichment":{"headline":"Not a traditional drug phase: Academic Performance Feedback for Major Depression","inPlainEnglish":"This study utilizes mobile health methods, including smartphone technology, subjective self-reports measures of emotion, behavioral tasks, functional Magnetic Resonance Imaging (fMRI), physiological measures of attention and arousal, and measures of health and social support to identify neural mechanisms associated with individual differences in the temporal course of emotional responses. The aim of this project is to utilize real-world and personally relevant events as stimuli to better understand how the temporal course of emotional responses relate to risk for developing mental disorders.","whoItsFor":["Ages 18 Years to 35 Years","Individuals who are fluent English speakers. \\[Reason: to understand study instructions \\& questionnaires\\]","Smart phone access. \\[Reason: to answer the questionnaires that are administered throughout the study"],"whoShouldSkip":["Women who are pregnant or breast feeding and are no more than six months post-partum. \\[Reason: may be unsafe for fetus, may affect outcome measure(s)\\]","Individuals who are excluded based on attached metal resonance Screening Form (Note: this form has already been approved by the Institutional Review Board (IRB for other protocols). \\[Reason: necessary to participate in MRI research protocol\\]","Individuals whose body-mass index (BMI) is above 35. \\[Reason: must fit into fMRI scanner\\]","Individuals who have claustrophobia. \\[Reason: to be able to stay in MRI scanner\\]","Individuals who are unable to safely undergo MRI scanning. \\[Reason: to be able to undergo MRI scanning\\]"],"whatHappens":"If you join, the listed intervention(s) are Academic Performance Feedback. The registry lists allocation as na. This study utilizes mobile health methods, including smartphone technology, subjective self-reports measures of emotion, behavioral tasks, functional Magnetic Resonance Imaging (fMRI), physiological measures of attention and arousal, and measures of health and social support to identify neural mechanisms associated with individual differences in the temporal course of emotional responses.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 144 people at Coral Gables. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.351Z"},{"nctId":"NCT07891702","title":"Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea","officialTitle":"Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea: A Prospective Interventional Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Mansoura University","sponsorClass":"OTHER","summary":"* The aim of this study is to assess the impact of transcutaneous electrical stimulation on polysomnographic findings in obstructive sleep apnea patients.\n* The hypothesis of the present study is that nocturnal delivery of transcutaneous electrical stimulation of the pharyngeal dilators, in particular the genioglossus, may help in treating the functional loss of the neuromuscular tone with sleep onset to keep the Upper airway patent during sleep which would reduce the severity of OSA as measured by the apnea-hypopnea-index (AHI), so representing an alternative and better-tolerated approach compared to usual care with CPAP.","conditions":["Obstructive Sleep Apnea"],"keywords":["Obstructive sleep apnea, electrical stimulation, polysomnography, AHI,"],"interventions":[{"type":"DEVICE","name":"Transcutaneous Electrical Stimulation"}],"enrollment":50,"startDate":"2025-07-06","completionDate":"2027-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1 - Adult patients aged 18 years or older. 2- Male or female patients diagnosed with obstructive sleep apnea by baseline overnight polysomnography.\n\n3- Patients willing to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with central sleep apnea or predominantly central sleep-disordered breathing.\n2. Patients with significant unstable cardiovascular or respiratory disease that may increase the risk of participation.\n3. Patients with implanted electronic devices, such as pacemakers or implantable cardioverter-defibrillators.\n4. Patients with skin lesions, infection, irritation, or other abnormalities at the intended electrode application sites.\n5. Patients with neurological or neuromuscular disorders that significantly affect upper airway muscle function.\n6. Patients with a history of upper airway surgery that substantially alters upper airway anatomy, if this may interfere with study assessment.\n7. Patients unable to tolerate electrical stimulation or complete the required polysomnography sessions.\n8. Patients who decline to participate or withdraw their informed consent.","locations":[{"facility":"Mansoura University","city":"Al Mansurah","state":"Dakahlia Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mohammed Shehta, Associate professor-chest med.","phone":"+201004344106","email":"dr_mshehta@mans.edu.eg"}],"primaryOutcomes":["Change in Apnea-Hypopnea Index (AHI)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["al-mansurah-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Transcutaneous Electrical Stimulation for Obstructive Sleep Apnea","inPlainEnglish":"* The aim of this study is to assess the impact of transcutaneous electrical stimulation on polysomnographic findings in obstructive sleep apnea patients. * The hypothesis of the present study is that nocturnal delivery of transcutaneous electrical stimulation of the pharyngeal dilators, in particular the genioglossus, may help in treating the functional loss of the neuromuscular tone with sleep onset to keep the Upper airway patent during sleep which would reduce the severity of OSA as measured by the apnea-hypopnea-index (AHI), so representing an alternative and better-tolerated approach compared to usual care with CPAP.","whoItsFor":["Ages 18 Years to any","1 - Adult patients aged 18 years or older. 2- Male or female patients diagnosed with obstructive sleep apnea by baseline overnight polysomnography"],"whoShouldSkip":["Patients with central sleep apnea or predominantly central sleep-disordered breathing","Patients with significant unstable cardiovascular or respiratory disease that may increase the risk of participation","Patients with implanted electronic devices, such as pacemakers or implantable cardioverter-defibrillators","Patients with skin lesions, infection, irritation, or other abnormalities at the intended electrode application sites","Patients with neurological or neuromuscular disorders that significantly affect upper airway muscle function","Patients with a history of upper airway surgery that substantially alters upper airway anatomy, if this may interfere with study assessment","Patients unable to tolerate electrical stimulation or complete the required polysomnography sessions"],"whatHappens":"If you join, the listed intervention(s) are Transcutaneous Electrical Stimulation. The registry lists allocation as na. * The aim of this study is to assess the impact of transcutaneous electrical stimulation on polysomnographic findings in obstructive sleep apnea patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Al Mansurah. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.946Z"},{"nctId":"NCT07895615","title":"Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis","officialTitle":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of LT-002-158 Tablets in Adult Patients With Moderate-to-Severe Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"TRIPLE","sponsor":"Leadingtac Pharmaceutical (Shaoxing) Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults. It will also learn about the safety of drug LT-002-158. The main questions it aims to answer are:\n\nDoes drug LT-002-158 reduce the signs and symptoms of moderate-to-severe atopic dermatitis in adults? What medical problems do participants have when taking drug LT-002-158? Researchers will compare drug LT-002-158 to a placebo (a look-alike substance that contains no drug) to see if drug LT-002-158 works to treat atopic dermatitis.\n\nParticipants will:\n\nTake drug LT-002-158 or a placebo every day for 16 weeks. Visit the clinic per the study plan for checkups and tests.","conditions":["Atopic Dermatitis (AD)"],"keywords":["IRAK4"],"interventions":[{"type":"DRUG","name":"LT-002-158"},{"type":"OTHER","name":"Placebo"}],"enrollment":160,"startDate":"2026-10","completionDate":"2028-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 18-75 years (inclusive) at the time of signing the Informed Consent Form (ICF), regardless of sex.\n2. Body mass index (BMI) \\>17.5 kg/m2, and body weight of ≥ 45.0 kg.\n3. A history of atopic dermatitis for at least 6 months prior to the screening visit (meeting the Hanifin-Rajka diagnostic criteria), and:\n\n   * EASI score ≥ 16 at the screening and baseline visits;\n   * vIGA score ≥ 3 at the screening and baseline visits;\n   * BSA ≥ 10% at the screening and baseline visits;\n   * A weekly average PP-NRS score of ≥ 4 at baseline (with at least 4 days of evaluation results during the week prior to baseline).\n4. Inadequate response, intolerance or inappropriateness for topical corticosteroid (TCS) or topical calcineurin inhibitor (TCI) therapy within 6 months prior to the baseline visit). Inadequate response is defined as failure to achieve and maintain remission or low disease activity (equivalent to vIGA 0 \\[ clear\\] to 2 \\[mild\\]) despite at least 28 days of treatment with a medium-to-high-potency TCS regimen (± TCI, as applicable), or for the maximum duration recommended in the product prescribing information (e.g., 14 days for super-potent TCS), whichever is shorter.\n5. Participants must apply a stable dose of topical emollients (moisturizer) daily for at least 7 consecutive days immediately prior to the baseline visit, and should be willing to continue using moisturizer throughout the study.\n6. Female participants of childbearing potential and male participants, as well as their partners, must have no plans to conceive during the study and for 6 months after the last dose, and must agree to use highly effective contraceptive methods.\n7. Able to understand and voluntarily sign the written informed consent form; willing and able to complete the scheduled visits, treatments, examinations, and other procedures (e.g., diary card recording and collection) in accordance with the protocol requirements.\n\nExclusion Criteria:\n\n1. Concurrent presence of other skin diseases that may interfere with study assessments, such as psoriasis, tinea corporis, lupus erythematosus, cutaneous T-cell lymphoma, and severe contact dermatitis.\n2. Presence of active, chronic, or recurrent infection requiring systemic anti-infective treatment within 4 weeks prior to the baseline visit; or presence of an infection that at baseline judged of the investigator to be inadequately controlled, such as infectious eczema, impetigo, cellulitis, or pneumonia.\n3. Known or suspected primary or secondary immunodeficiency disease; history of splenectomy or functional asplenia.\n4. Presence of other active autoimmune diseases (excluding allergic rhinitis and asthma) or a history of invasive opportunistic infections.\n\nOther exclusion criteria specified in the protocol.","locations":[{"facility":"Hangzhou First People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Juan Xu, Ph.D","phone":"18360466466","email":"jxu@leadingtac.com"}],"primaryOutcomes":["Eczema Area and Severity Index (EASI) score"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Phase 2: testing LT-002-158 for Atopic Dermatitis (AD)","inPlainEnglish":"The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults. It will also learn about the safety of drug LT-002-158.","whoItsFor":["Ages 18 Years to 75 Years","Body mass index (body-mass index (BMI)) \\>17.5 kg/m2, and body weight of ≥ 45.0 kg","A history of atopic dermatitis for at least 6 months prior to the screening visit (meeting the Hanifin-Rajka diagnostic criteria), and:","EASI score ≥ 16 at the screening and baseline visits;","vIGA score ≥ 3 at the screening and baseline visits;","BSA ≥ 10% at the screening and baseline visits;","A weekly average PP-NRS score of ≥ 4 at baseline (with at least 4 days of evaluation results during the week prior to baseline)","Participants must apply a stable dose of topical emollients (moisturizer) daily for at least 7 consecutive days immediately prior to the baseline visit, and should be willing to continue using moisturizer throughout the study"],"whoShouldSkip":["Concurrent presence of other skin diseases that may interfere with study assessments, such as psoriasis, tinea corporis, lupus erythematosus, cutaneous T-cell lymphoma, and severe contact dermatitis","Known or suspected primary or secondary immunodeficiency disease; history of splenectomy or functional asplenia","Presence of other active autoimmune diseases (excluding allergic rhinitis and asthma) or a history of invasive opportunistic infections"],"whatHappens":"If you join, the listed intervention(s) are LT-002-158, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if drug LT-002-158 works to treat moderate-to-severe atopic dermatitis in adults.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 160 people at Hangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.832Z"},{"nctId":"NCT07896109","title":"A Research Study to Check the Safety of NNC9836-0001 When Given to Healthy Participants and Participants With Type 2 Diabetes","officialTitle":"A Phase 1 Randomised, Double-blinded, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of NNC9836-0001 Administered to Healthy Participants and Participants With Type 2 Diabetes","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"DOUBLE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or placebo. Which treatment participants get is decided by chance. NNC9836-0001 is a new medicine aimed to treat type 2 diabetes.","conditions":["Diabetes Mellitus, Type 2"],"keywords":[],"interventions":[{"type":"DRUG","name":"NNC9836-0001"},{"type":"DRUG","name":"Placebo (NaCl)"}],"enrollment":121,"startDate":"2026-10-22","completionDate":"2028-07-26","sex":"ALL","minAge":"25 Years","maxAge":"69 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAll participants:\n\n* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.\n* Male or female (sex assigned at birth, inclusive of all gender identities).\n\nMetabolically healthy participants with overweight or mild obesity:\n\n* Age 25 to 59 years (both inclusive) at the time of signing the informed consent.\n* Body Mass Index (BMI) 25 to 34.9 kilogram per square meter (kg/m\\^2) (both inclusive) at screening.\n* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.\n\nParticipants with type 2 diabetes:\n\n* Age at the time of signing the informed consent: Age 25 to 69 years (both inclusive)\n* BMI at screening: BMI 27 to 39.9 kg/m\\^2 (both inclusive)\n* Diagnosed with T2D greater than equal to (≥) 180 days before screening.\n* Concomitant medications before screening: Stable (as judged by the investigator) with daily dose(s) on monotherapy (metformin, sodium-glucose cotransporter 2 inhibitors (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i) or dual therapy (metformin + SGLT2i or metformin + DPP4i)) ≥90 days before screening. or; Stable weight and stable doses of glucagon-like peptide-1 receptor agonists (GLP-1 RA) with no further titration (as judged by the investigator). GLP-1 RA ≥180 days before screening combined with daily dose(s) of either metformin or SGLT2i or dual therapy (metformin + SGLT2i)) ≥90 days before screening.\n* Background pharmacotherapy for all MAD cohort T2D participants should be on stable therapy for ≥90 days before screening with no initiation, discontinuation, or dose changes.\n* Considered to be generally healthy as judged by the investigator except for T2D-associated mild conditions under stable treatment.\n\nExclusion Criteria:\n\nAll participants:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Previous dose administration in this study.\n* Participation (i.e., signed informed consent and dosed with Investigational medicinal product (IMP)) in any other interventional clinical study within 30 days or 5 times the half-life of the drug, whichever is longest, before screening.\n* Any disorder, which in the investigator's opinion might jeopardise participants safety or compliance with the protocol.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.\n* Minimal to mild hepatic impairment, defined as alanine aminotransferase (ALT) values greater than (\\>)1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) values \\>1.5 × ULN, or total bilirubin \\>ULN + 20 percent (%) (except in case of Gilbert's disease, as reported by participant or in medical records) at screening.\n\nMetabolically healthy participants with overweight or mild obesity:\n\n* Supine blood pressure outside the range of 90-139 millimetres of mercury (mmHg) for systolic or 50-89 mmHg for diastolic at screening. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.\n* Heart rate outside the range of 45-89 beats per minute (bpm) at screening.\n* Unwilling or unable to refrain from use of nonprescription products within 14 days prior to start of run-in, including herbal products and nonroutine vitamins (as judged by the investigator), except the occasional use of over the counter (OTC) acetaminophen or non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain.\n* Recent (\\<90 days) or planned major change in diet, use of weight-lowering medication, regularly extended fasting periods, or dietary habits that, per investigator's judgment, may interfere with the conduct of the study.\n\nParticipants with type 2 diabetes:\n\n* Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol. This does not apply for T2D-associated mild conditions under stable treatment.\n* Supine blood pressure outside the range of 90-159 mmHg for systolic or 50-99 mmHg for diastolic at screening. This exclusion criterion also pertains to participants being on antihypertensive treatment. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected.\n* Heart rate outside the range of 50-99 bpm at screening.\n* Unwilling or unable to check self-monitored plasma glucose (SMPG) and unwilling to treat hypoglycaemia per instructions.","locations":[{"facility":"Profil Institut für Stoffwechselforschung GmbH","city":"Neuss","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["Single ascending dose (SAD): Number of Treatment emergent adverse events (TEAEs)","Multiple ascending dose (MAD): Number of TEAEs"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["neuss-germany"],"enrichment":{"headline":"Phase 1: testing NNC9836-0001 for Diabetes Mellitus, Type 2","inPlainEnglish":"The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D). Participants will either get the study medicine NNC9836-0001 or dummy treatment (placebo).","whoItsFor":["Ages 25 Years to 69 Years","Male or female (sex assigned at birth, inclusive of all gender identities)","Metabolically healthy participants with overweight or mild obesity:","Body Mass Index (body-mass index (BMI)) 25 to 34.9 kilogram per square meter (kg/m\\^2) (both inclusive) at screening","Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator","Participants with type 2 diabetes:","body-mass index (BMI) at screening: body-mass index (BMI) 27 to 39.9 kg/m\\^2 (both inclusive)","Diagnosed with T2D greater than equal to (≥) 180 days before screening"],"whoShouldSkip":["Known or suspected hypersensitivity to study intervention(s) or related products","Previous dose administration in this study","Any disorder, which in the investigator's opinion might jeopardise participants safety or compliance with the protocol","Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method","Metabolically healthy participants with overweight or mild obesity:","Supine blood pressure outside the range of 90-139 millimetres of mercury (mmHg) for systolic or 50-89 mmHg for diastolic at screening. To consider re-assessment of vital signs in case white-coat hypertension is known or suspected","Heart rate outside the range of 45-89 beats per minute (bpm) at screening"],"whatHappens":"If you join, the listed intervention(s) are NNC9836-0001, or Placebo (NaCl). The registry lists allocation as randomized. The purpose of this clinical study is to determine if the study medicine NNC9836-0001 is safe and tolerable in healthy participants with overweight or obesity or who have type 2 diabetes (T2D).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 121 people at Neuss. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.513Z"},{"nctId":"NCT07896642","title":"Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography","officialTitle":"Investigation of Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Istanbul Health and Technology University","sponsorClass":"OTHER","summary":"This study will investigate brown adipose tissue-related physiological responses in women with polycystic ovary syndrome (PCOS). Women with PCOS who have normal body mass index, women with PCOS who are overweight or have obesity, and healthy women will be compared. Brown adipose tissue-related heat responses will be evaluated using non-invasive infrared thermography of the supraclavicular region, together with serum UCP-1 levels and metabolic measurements. Participants in the overweight/obesity PCOS group will receive an inositol supplement for 12 weeks, and measurements will be repeated after supplementation. The study will also examine possible relationships between surface temperature responses, dietary intake, physical activity, body measurements, and metabolic and hormonal markers.","conditions":["Polycystic Ovary Syndrome (PCOS)"],"keywords":["Polycystic Ovary Syndrome","Brown Adipose Tissue","Infrared Thermography","Inositol","Thermogenesis","Uncoupling Protein 1 (UCP-1)","Nutrition"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"inositol"}],"enrollment":60,"startDate":"2026-09","completionDate":"2026-12","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Female participants aged 18-40 years\n* Premenopausal status\n* Ability and willingness to provide written informed consent\n* For the Overweight/Obesity PCOS - Inositol and Normal-BMI PCOS Reference Group arms:\n* Diagnosis of polycystic ovary syndrome (PCOS) established by an obstetrician and gynecologist according to the Rotterdam criteria\n* For the Normal-BMI PCOS Reference Group arm:\n* BMI 18.5-24.9 kg/m²\n* For the Overweight/Obesity PCOS - Inositol arm:\n* BMI ≥25 kg/m²\n* For the Healthy Control Group arm:\n* BMI 18.5-24.9 kg/m²\n* Regular menstrual cycles\n* Normal ovarian morphology\n* No diagnosis of PCOS\n\nExclusion Criteria:\n\n* Male sex\n* Age ≤17 years or ≥41 years\n* Menopausal status\n* BMI \\<18.5 kg/m²\n* Pregnancy or breastfeeding\n* Regular smoking or alcohol consumption\n* Being highly physically active, defined as regular exercise during the previous 6 months or being a professional athlete\n* Presence of endocrine disorders that may affect the diagnosis of PCOS, including thyroid disease, congenital adrenal hyperplasia, androgen-secreting tumors, or Cushing syndrome\n* Any intervention for PCOS treatment within the previous 6 months, including pharmacological treatment or alternative approaches such as acupuncture\n* History of ovarian surgery\n* Presence of any of the following conditions:\n* Secondary hypertension\n* Cardiovascular, cerebrovascular, renal, hepatic, thyroid, or pulmonary disease\n* Any type of cancer\n* Acute infection\n* Autoimmune disease\n* Severe psychological or neurological disease\n* Following a special diet that may affect metabolic rate, including vegetarian, vegan, diabetic, or low-calorie diets\n* Regular use of dietary supplements such as probiotics or prebiotics\n* History of obesity-specific treatment, including bariatric surgery or anti-obesity medication\n* Regular medication use within the previous 3 months or currently, particularly oral contraceptives, hormonal medications, or medications affecting metabolism","locations":[{"facility":"Bezmialem Vakif University Faculty of Medicine Hospital","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istanbul Health and Technology University","city":"Istanbul","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"RANA TURGUT YAMAN","phone":"+90 506 775 72 28","email":"ranaturgut8@hotmail.com"}],"primaryOutcomes":["Supraclavicular Skin Temperature (Tscv)","Serum Uncoupling Protein 1 (UCP-1) Level"],"hasResults":false,"conditionSlugs":["als","obesity","pcos"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: inositol for Polycystic Ovary Syndrome (PCOS)","inPlainEnglish":"This study will investigate brown adipose tissue-related physiological responses in women with polycystic ovary syndrome (PCOS). Women with PCOS who have normal body mass index, women with PCOS who are overweight or have obesity, and healthy women will be compared.","whoItsFor":["Ages 18 Years to 40 Years","Women only","Female participants aged 18-40 years","Premenopausal status","For the Overweight/Obesity PCOS - Inositol and Normal-body-mass index (BMI) PCOS Reference Group arms:","Diagnosis of polycystic ovary syndrome (PCOS) established by an obstetrician and gynecologist according to the Rotterdam criteria","For the Normal-body-mass index (BMI) PCOS Reference Group arm:","body-mass index (BMI) 18.5-24.9 kg/m²","For the Overweight/Obesity PCOS - Inositol arm:"],"whoShouldSkip":["Age ≤17 years or ≥41 years","Pregnancy or breastfeeding","Regular smoking or alcohol consumption","Being highly physically active, defined as regular exercise during the previous 6 months or being a professional athlete","Presence of endocrine disorders that may affect the diagnosis of PCOS, including thyroid disease, congenital adrenal hyperplasia, androgen-secreting tumors, or Cushing syndrome","Any intervention for PCOS treatment within the previous 6 months, including pharmacological treatment or alternative approaches such as acupuncture","History of ovarian surgery"],"whatHappens":"If you join, the listed intervention(s) are inositol. The registry lists allocation as randomized. This study will investigate brown adipose tissue-related physiological responses in women with polycystic ovary syndrome (PCOS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.787Z"},{"nctId":"NCT07897981","title":"High-Plant-Protein-Diet or High-Animal-Protein-Diet for Improving Alcoholic Fatty Liver Disease","officialTitle":"Efficacy and Safety of a High-Plant-Protein-Diet or High-Animal-Protein-Diet in Patients With Alcoholic Fatty Liver Disease: A Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Li Lab,MD","sponsorClass":"OTHER_GOV","summary":"Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually. In China, both per capita alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant public health burden. Alcohol-associated fatty liver disease (AFLD), the initial and most reversible stage of ALD, is pathologically characterized by excessive hepatic lipid accumulation, mild hepatocellular injury, and low-grade inflammation. It can progress to alcoholic hepatitis, and in some patients, advance to hepatic fibrosis, cirrhosis, or even hepatocellular carcinoma. Currently, there is no established effective pharmacotherapy for AFLD; although alcohol abstinence remains the optimal strategy for disease reversal, sustained abstinence is often difficult to achieve among individuals with alcohol dependence. Dietary protein source may independently influence metabolic health beyond total protein intake. Plant proteins (primarily derived from legumes and cereals) are rich in arginine, glutamine, and fiber-associated bioactive compounds, whereas animal proteins (mainly from dairy and poultry) are abundant in branched-chain amino acids (BCAAs) and sulfur-containing amino acids. Preclinical studies have demonstrated that, compared with animal proteins such as casein, plant proteins more effectively attenuate high-fat- or alcohol-induced hepatic steatosis by upregulating hepatic PPAR-α expression and suppressing SREBP-1c activity. Human intervention studies further suggest that long-term higher intake of plant protein is associated with lower hepatic fat content and reduced risk of insulin resistance. However, no randomized controlled trial has yet directly compared the effects of high-purity plant protein versus animal protein supplementation on clinical outcomes in patients with AFLD under isocaloric and isonitrogenous conditions. Therefore, this study aims to conduct a randomized controlled trial to evaluate the effects of plant protein versus animal protein supplementation within an isocaloric dietary framework on liver function, hepatic fat content, and glucose-lipid metabolism in individuals with AFLD. The findings will elucidate the efficacy and underlying mechanisms of protein-source modulation in ameliorating AFLD, thereby providing population-based evidence and strategic guidance for health promotion in this patient population.","conditions":["Alcohol-associated Fatty Liver Disease"],"keywords":["alcohol-associated fatty liver disease（AFLD）","high-animal-protein-diet","high-plant-protein-diet","Intrahepatic lipid (IHL)","liver iron concentration (LIC)"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"whey protein powder"},{"type":"DIETARY_SUPPLEMENT","name":"soy protein powder"}],"enrollment":74,"startDate":"2026-10-10","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"74 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged between 18 and 74 years old.\n2. Able to understand the study and voluntarily sign the informed consent form.\n3. Meet the clinical diagnostic criteria for alcohol-associated fatty liver disease (AFLD): a history of alcohol consumption for ≥5 years, with an average daily ethanol intake of ≥20 g/d; clinically diagnosed with fatty liver (indicated by abdominal ultrasound or a liver MRI proton density fat fraction \\[MRI-PDFF\\] ≥5.2%).\n\nExclusion Criteria:\n\n1. Average daily ethanol intake \\>80 g/d.\n2. Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis.\n3. Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency.\n4. Patients with tumors or other severe systemic diseases.\n5. Patients with gastrointestinal disorders, or those with known protein allergy or intolerance.\n6. Long-term use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone or tamoxifen), nutritional supplements, or probiotics.\n7. Total daily energy intake (excluding energy from alcohol) \\<1900 kcal or ≥2900 kcal.\n8. Participation in another interventional study within the past year, or scheduled to receive non-study treatments during the trial period.","locations":[{"facility":"Zhejiang Chinese Medical University","city":"Hangzhou","state":"None Selected","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Qingling Huang","phone":"+8615267148306","email":"hqingling0306@163.com"},{"name":"Xianjun Liu","phone":"+8615958143460","email":"1589362788@qq.com"}],"primaryOutcomes":["Intrahepatic lipid (IHL)"],"hasResults":false,"conditionSlugs":["liver-cancer","als"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Phase 1 / Phase 2: whey protein powder for Alcohol-associated Fatty Liver Disease","inPlainEnglish":"Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually. In China, both per capita alcohol consumption and the prevalence of ALD (approximately 5.15%) are on the rise, making ALD an increasingly significant public health burden.","whoItsFor":["Ages 18 Years to 74 Years","Aged between 18 and 74 years old"],"whoShouldSkip":["Average daily ethanol intake \\>80 g/d","Presence of other hepatobiliary diseases, such as autoimmune liver disease, viral hepatitis, liver fibrosis, or cirrhosis","Presence of severe cardiovascular or cerebrovascular diseases, or renal insufficiency","Patients with tumors or other severe systemic diseases","Patients with gastrointestinal disorders, or those with known protein allergy or intolerance","Long-term use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone or tamoxifen), nutritional supplements, or probiotics","Total daily energy intake (excluding energy from alcohol) \\<1900 kcal or ≥2900 kcal"],"whatHappens":"If you join, the listed intervention(s) are whey protein powder, or soy protein powder. The registry lists allocation as randomized. Alcohol-associated liver disease (ALD) is a major cause of mortality from advanced liver disease, accounting for 47.9% of cirrhosis-related deaths and 30% of hepatocellular carcinoma-related deaths annually.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 74 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.153Z"},{"nctId":"NCT07898397","title":"Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke","officialTitle":"Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Strasbourg, France","sponsorClass":"OTHER","summary":"Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms emerge. Potential long-term consequences include motor deficits, cognitive and learning difficulties, language disorders, and epilepsy.\n\nPost-stroke epilepsy is estimated to affect approximately 30% of children who experience perinatal stroke. Although neonatal outcomes are relatively well characterized, the long-term course of epilepsy in this population and the relationship between initial stroke characteristics and subsequent epilepsy outcomes remain insufficiently studied.\n\nThe primary objective of this retrospective, multicenter, observational study is to characterize the long-term course of epilepsy in children who experienced an ischemic or hemorrhagic stroke before 28 days of age.","conditions":["Perinatal Stroke","Epilepsy","Post-Stroke Epilepsy"],"keywords":["Perinatal stroke","Pediatric epilepsy","Drug-resistant epilepsy"],"interventions":[],"enrollment":120,"startDate":"2026-04-28","completionDate":"2027-02-28","sex":"ALL","minAge":"5 Years","maxAge":"25 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Minors aged 5 to under 18 years or adults aged 18 to 25 years.\n* Patients who attended one of the two participating centers: Strasbourg University Hospitals or Necker Hospital (AP-HP).\n* Confirmed or suspected ischemic or hemorrhagic stroke occurring before 28 days of age.\n* During follow-up, presentation of criteria for focal epilepsy, infantile spasms, continuous spike-and-wave during sleep (CSWS), or Lennox-Gastaut syndrome.\n\nExclusion Criteria:\n\n* Birth before 34 weeks of gestation.\n* Birth weight below 1,500 g.\n* Perinatal hypoxic-ischemic injury with residual MRI lesions.\n* Insufficient information in medical records.\n* Refusal to participate in the study.","locations":[{"facility":"Service de Pédiatrie 1 - Hôpital de Hautepierre - CHU de Strasbourg, France","city":"Strasbourg","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sarah Baer, MD","phone":"33 3 88 12 84 98","email":"sarah.baer@chru-strasbourg.fr"}],"primaryOutcomes":["Drug-Resistant Epilepsy at 6 Years of Age","Adapted Schooling at 6 Years of Age"],"hasResults":false,"conditionSlugs":["epilepsy","stroke"],"drugSlugs":[],"locationSlugs":["strasbourg-france"],"enrichment":{"headline":"Long-Term Epilepsy Outcomes in Children With a History of Perinatal Stroke","inPlainEnglish":"Perinatal stroke is a rare condition affecting approximately 20-40 births per 100,000. It may be ischemic or hemorrhagic and can occur before or around birth, with diagnosis sometimes delayed until motor or cognitive symptoms emerge.","whoItsFor":["Ages 5 Years to 25 Years","Minors aged 5 to under 18 years or adults aged 18 to 25 years","Patients who attended one of the two participating centers: Strasbourg University Hospitals or Necker Hospital (AP-HP)","Confirmed or suspected ischemic or hemorrhagic stroke occurring before 28 days of age","During follow-up, presentation of criteria for focal epilepsy, infantile spasms, continuous spike-and-wave during sleep (CSWS), or Lennox-Gastaut syndrome"],"whoShouldSkip":["Birth before 34 weeks of gestation","Birth weight below 1,500 g","Perinatal hypoxic-ischemic injury with residual MRI lesions","Insufficient information in medical records","Refusal to participate in the study"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 120 people at Strasbourg. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.916Z"},{"nctId":"NCT07899502","title":"REAL-MS: Observational Database Study of AHSCT and MS Therapies","officialTitle":"Real-World Effectiveness and Safety of Autologous Haematopoietic Stem Cell Transplantation and Other Therapeutic Strategies in Multiple Sclerosis (REAL-MS) - An Observational Database Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Imperial College London","sponsorClass":"OTHER","summary":"Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity. For some people with highly active MS, autologous haematopoietic stem cell transplantation (AHSCT) may be used. AHSCT uses a person's own blood-forming stem cells after treatment that suppresses the immune system.\n\nREAL-MS is an observational study that will collect and analyse information from routine clinical care to compare the longer-term effectiveness and safety of AHSCT with high-efficacy disease-modifying therapies for adults with MS. High-efficacy therapies include medicines such as alemtuzumab, cladribine, natalizumab, and anti-CD20 antibody treatments, as well as other high-efficacy disease-modifying therapies that may become available during the study.","conditions":["Multiple Sclerosis","Multiple Sclerosis (MS) - Relapsing-remitting","Multiple Sclerosis (MS) Primary Progressive"],"keywords":["autologous haematopoietic stem cell transplant","AHSCT","ocrelizumab","ofatumumab","ublituximab","natalizumab","cladribine","alemtuzumab"],"interventions":[{"type":"PROCEDURE","name":"Autologous haematopoietic stem cell transplantation (AHSCT)"},{"type":"DRUG","name":"High-efficacy disease-modifying therapy (HE-DMT)"}],"enrollment":2000,"startDate":"2026-10-07","completionDate":"2032-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Diagnosis of MS according to the appropriate diagnostic criteria at the time of diagnosis;\n* Age ≥ 18 years old at the time of the inclusion in the study;\n* Treatment with AHSCT or a H-E DMT at a participating centre. Eligible H-E DMTs will include anti-CD20 monoclonal antibodies, natalizumab, alemtuzumab, cladribine, and other therapies approved by the study management group during the study period;\n* Availability of a minimum required baseline dataset as defined in the study case report form and data dictionary;\n* Availability of at least one post-baseline clinical assessment, unless the patient is included in safety analyses only;\n* For participation in the prospective phase of the study, capacity to provide informed consent, as judged by the investigator, and provision of written informed consent where required by applicable local regulations and ethics approvals;\n\nExclusion Criteria:\n\n* Age \\<18 years at the time of study inclusion;\n* Insufficient baseline data to confirm eligibility, treatment exposure, or key study variables;\n* No post-baseline follow-up data, unless the participant is included in safety analyses only;\n* Concurrent participation in an interventional randomised controlled trial where inclusion in the study would conflict with the trial protocol or compromise interpretation of study outcomes;\n* Lack of informed consent for prospective participation","locations":[{"facility":"Imperial College Healthcare NHS Trust","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null},{"facility":"King's College Hospital NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University College London Hospitals NHS Foundation Trust","city":"London","state":"","country":"United Kingdom","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["No Evidence of Disease Activity (NEDA-3)"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":["ocrelizumab","ofatumumab"],"locationSlugs":["london-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing High-efficacy disease-modifying therapy (HE-DMT) for Multiple Sclerosis","inPlainEnglish":"Multiple sclerosis (MS) is a condition in which the immune system damages the brain and spinal cord. Treatments called disease-modifying therapies can reduce inflammation and disease activity.","whoItsFor":["Ages 18 Years to any","Diagnosis of MS according to the appropriate diagnostic criteria at the time of diagnosis;","Age ≥ 18 years old at the time of the inclusion in the study;","Treatment with AHSCT or a H-E DMT at a participating centre. Eligible H-E DMTs will include anti-CD20 monoclonal antibodies, natalizumab, alemtuzumab, cladribine, and other therapies approved by the study management group during the study period;","Availability of a minimum required baseline dataset as defined in the study case report form and data dictionary;","Availability of at least one post-baseline clinical assessment, unless the patient is included in safety analyses only;"],"whoShouldSkip":["Age \\<18 years at the time of study inclusion;","Insufficient baseline data to confirm eligibility, treatment exposure, or key study variables;","No post-baseline follow-up data, unless the participant is included in safety analyses only;","Concurrent participation in an treatment randomly assigned controlled trial where inclusion in the study would conflict with the trial protocol or compromise interpretation of study outcomes;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at 3 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.990Z"},{"nctId":"NCT07900074","title":"Mechanisms of Weight Loss: Tirzepatide vs Semaglutide","officialTitle":"Mechanisms of Weight Loss Due to Dual GIP GLP-1 Receptor Agonism With Tirzepatide Compared to Semaglutide: A Randomized Controlled Trial","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"McMaster University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to determine if there are differences in the effect of 12 weeks of tirzepatide versus semaglutide on energy balance in adults with obesity and without known diabetes. The main questions it aims to answer are:\n\n\\- Does tirzepatide have a greater effect on energy expenditure or energy extraction than semaglutide?\n\nParticipants will:\n\n* Take tirzepatide or semaglutide once weekly for 12 weeks\n* Undergo identical baseline and week 12 study visits (including 24-hour whole room indirect calorimeter testing, MRI scan, body composition, 3-day meal plan and stool collection)","conditions":["Obesity (Disorder)"],"keywords":["Obesity","Semaglutide","Tirzepatide","Energy balance","Energy expenditure","GLP-1 receptor agonist","dual GIP GLP-1 receptor agonist","Weight loss","Weight loss drug","Whole room indirect calorimetry","MRI","Brown adipose tissue","Cold exposure"],"interventions":[{"type":"DRUG","name":"Tirzepatide"},{"type":"DRUG","name":"Semaglutide"}],"enrollment":80,"startDate":"2026-10-31","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-60 years\n* Body mass index (BMI) \\>30 kg/m2\n* Stable body weight (\\<5kg change in the 3 months prior to screening)\n\nExclusion Criteria:\n\n* History of type 1 or type 2 diabetes or current diagnosis\n* Glucose-lowering or weight loss drugs in the last 3 months or planned in the next 3 months\n* Prior or planned bariatric surgery or planned low calorie meal program in the next 3 months\n* Known clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction) or chronic GI symptoms (nausea, vomiting, diarrhea, constipation, bloating or unexplained abdominal pain) or chronically take drugs that directly affect GI motility\n* Known liver disease other than non-alcoholic fatty liver disease, or ALT \\>3x ULN\n* Intake of standard alcoholic drinks more than 21/week for men, or 14/week for women\n* Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2\n* History of pancreatitis\n* Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2\n* Currently pregnant/breastfeeding, previous pregnancy within the last 6 months, or unwillingness to use contraception for 3 months\n* Other medications, allergies or comorbidities that, in the opinion of the investigator could interfere with study medication or study measures (e.g., catecholamine medications) or current medication use that has been unstable in the past 8 weeks or expected to change within the next 3 months\n* Claustrophobia precluding a 24 hour stay in a whole room calorimeter or MRI scan\n* Inability to undergo MRI (weight \\>250 kg, incompatible implanted device, e.g., pacemaker)\n* Use of cannabis or its related products (d-9-THC, CBD, d-8-THC, and cannabinol) in the past three months\n* Use of nicotine/tobacco that has been unstable in the past 8 weeks or expected to change within the next 3 months (exclusion from MRI visit ONLY)\n* Known monogenic, syndromic hypothalamic causes of obesity\n* Not able to communicate in English\n* History of cardiac conditions that precludes exercise\n* Participation in any intervention clinical study within 90 days before screening\n* History of eating disorder within the last year","locations":[{"facility":"McMaster University","city":"Hamilton","state":"Ontario","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Autumn Lawrence, MSc","phone":"905-525-9140","email":"joule3@mcmaster.ca"},{"name":"Aaron Thomas, PhD","phone":"905-525-9140","email":"joule3@mcmaster.ca"}],"primaryOutcomes":["24-hour Energy Expenditure Measured Using Whole Room Indirect Calorimetry"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["hamilton-canada"],"enrichment":{"headline":"Phase 4: testing Tirzepatide for Obesity (Disorder)","inPlainEnglish":"The goal of this clinical trial is to determine if there are differences in the effect of 12 weeks of tirzepatide versus semaglutide on energy balance in adults with obesity and without known diabetes. The main questions it aims to answer are: \\- Does tirzepatide have a greater effect on energy expenditure or energy extraction than semaglutide?","whoItsFor":["Ages 18 Years to 60 Years","Body mass index (body-mass index (BMI)) \\>30 kg/m2","Stable body weight (\\<5kg change in the 3 months prior to screening)"],"whoShouldSkip":["History of type 1 or type 2 diabetes or current diagnosis","Glucose-lowering or weight loss drugs in the last 3 months or planned in the next 3 months","Prior or planned bariatric surgery or planned low calorie meal program in the next 3 months","Known liver disease other than non-alcoholic fatty liver disease, or ALT \\>3x ULN","Intake of standard alcoholic drinks more than 21/week for men, or 14/week for women","Estimated glomerular filtration rate (eGFR) \\<30 mL/min/1.73 m2","History of pancreatitis"],"whatHappens":"If you join, the listed intervention(s) are Tirzepatide, or Semaglutide. The registry lists allocation as randomized. The goal of this clinical trial is to determine if there are differences in the effect of 12 weeks of tirzepatide versus semaglutide on energy balance in adults with obesity and without known diabetes.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 80 people at Hamilton. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.726Z"},{"nctId":"NCT07900438","title":"A Research Study Looking at Kidney and Heart Health in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China","officialTitle":"A Study of Kidney and Cardiovascular Endpoints in Adults With Type 2 Diabetes and Chronic Kidney Disease Treated With Semaglutide in China","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Novo Nordisk A/S","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin. The clinical study will also look at whether this medicine is safe for adults who have type 2 diabetes (T2D) and chronic kidney disease (CKD). This study will last for about 60 to 172 weeks.","conditions":["Cardiovascular Risk","Chronic Kidney Disease"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide"}],"enrollment":300,"startDate":"2026-10-12","completionDate":"2029-12-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years or above at the time of signing the informed consent\n2. Diagnosed with type 2 diabetes (T2D)\n3. HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole \\[mmol/mol\\])\n4. Kidney impairment defined either by:\n\n   * serum creatinine-based eGFR greater than or equal to (≥) 50 and less than or equal to (≤) 75 mL/min/1.73 m\\^2 (CKD-EPI, 2009) and UACR greater than (\\>) 300 and less than (\\<) 5000 milligrams per gram (mg/g) or\n   * serum creatinine-based eGFR ≥ 25 and \\< 50 mL/min/1.73 m\\^2 (CKD-EPI, 2009) and UACR \\> 100 and \\< 5000 mg/g\n5. Treatment with maximum labelled or tolerated dose of a renin-angiotensin-aldosterone system (RAAS) blocking agent including an angiotensin-converting enzyme inhibitor or an angiotensin II receptor blocker (ARB), unless such treatment is contraindicated or not tolerated. Treatment dose must be stable for at least 4 weeks prior to the date of the laboratory assessments used for determination of inclusion criterion and kept stable until screening.\n\nLaboratory results for inclusion can be based on:\n\n* measurements no more than 90 days old at screening, documented in medical records or\n* central laboratory measurement obtained at the screening visit If using UACR and eGFR values from medical records for inclusion, these values must be entered in the electronic case report form.\n\nThe number of participants with inclusion eGFR ≥ 60 mL/min/1.73 m\\^2 will be capped at 20% of enrolled participants.\n\nExclusion Criteria:\n\n1. Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations.\n2. Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA) within 30 days prior to screening. This also includes dual agonists containing a GLP1 RA component.\n3. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening.\n4. Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis.\n5. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and optical coherence tomography performed within the past 90 days prior to screening or in the period between screening and enrolment. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.\n6. Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB).","locations":[{"facility":"Fu Yang People's Hospital-Nephrology","city":"Fuyang","state":"Anhui","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Anzhen Hospital, Capital Medical University-Nephrology","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peking University First Hospital-Nephrology","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Friendship Hospital, Capital Medical University-Nephrology","city":"Beijing","state":"Beijing Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital & Clinical Medical School, Lanzhou University-Nephrology","city":"Lanzhou","state":"Gansu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huizhou Central People's Hospital-Endocrinology","city":"Huizhou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Shantou University Medical College-Nephrology","city":"Shantou","state":"Guangdong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Hospital of Hebei Medical University-Nephrology","city":"Shijiazhuang","state":"Hebei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The People's Hospital of Anyang City/ TGE Center Hospital of Anyang City-Nephrology","city":"Anyang","state":"Henan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yichang Central People's Hospital-Nephrology","city":"Yichang","state":"Hubei","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Baotou Medical College-Nephrology","city":"Baotou","state":"Inner Mongolia","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Changzhou No.2 People's Hospital-Nephrology","city":"Changzhou","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital of Nanjing Medical University-Endocrinology","city":"Nanjing","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Affiliated Hospital of Jiangsu University-Endocrinology","city":"Zhenjiang","state":"Jiangsu","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Pingxiang People's Hospital-Endocrinology","city":"Pingxiang","state":"Jiangxi","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Norman Bethune Hospital of Jilin University-Nephrology","city":"Changchun","state":"Jilin","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Siping City Central People's Hospital-Nephrology","city":"Siping","state":"Jilin","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Central Hospital of Dalian University of Technology (Dalian Municipal Central Hospital) -Nephrology","city":"Dalian","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Panjin Liaoyou Gemflower Hospital-Nephrology","city":"Panjin","state":"Liaoning","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Qinghai Provincial People's Hospital-Endocrinology","city":"Xining","state":"Qinghai","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Jinan Central Hospital-General Medicine","city":"Jinan","state":"Shandong","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shanghai General Hospital-Nephrology","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital; Affiliated Hospital of UESTC-Nephrology","city":"Chengdu","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second People's Hospital of Yibin-Department of Nephrology","city":"Yibin","state":"Sichuan","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province-Nephrology","city":"Linhai","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo No. 2 Hospital-Nephrology","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novo Nordisk","phone":"(+1) 866-867-7178","email":"clinicaltrials@novonordisk.com"}],"primaryOutcomes":["Time to first occurrence of a composite endpoint consisting of: Onset of persistent reduction of ≥ 50% in eGFR compared with baseline, Onset of persistent eGFR < 15 mL/min/1.73 m^2, Initiation of chronic kidney replacement therapy, Kidney death, CV death"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","chronic-kidney-disease"],"drugSlugs":["semaglutide"],"locationSlugs":["fuyang-china","beijing-china","lanzhou-china","huizhou-china","shantou-china","shijiazhuang-china","anyang-china","yichang-china","baotou-china","changzhou-china","nanjing-china","zhenjiang-china","pingxiang-china","changchun-china","siping-china","dalian-china","panjin-china","xining-china","jinan-china","shanghai-china","chengdu-china","yibin-china","linhai-china","ningbo-china"],"enrichment":{"headline":"Phase 4: testing Semaglutide for Cardiovascular Risk","inPlainEnglish":"The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin. The clinical study will also look at whether this medicine is safe for adults who have type 2 diabetes (T2D) and chronic kidney disease (CKD).","whoItsFor":["Ages 18 Years to any","Diagnosed with type 2 diabetes (T2D)","HbA1c less than or equal to (≤) 10 % (≤ 86 millimoles per mole \\[mmol/mol\\])","Kidney impairment defined either by:","serum creatinine-based eGFR greater than or equal to (≥) 50 and less than or equal to (≤) 75 mL/min/1.73 m\\^2 (CKD-EPI, 2009) and UACR greater than (\\>) 300 and less than (\\<) 5000 milligrams per gram (mg/g) or","serum creatinine-based eGFR ≥ 25 and \\< 50 mL/min/1.73 m\\^2 (CKD-EPI, 2009) and UACR \\> 100 and \\< 5000 mg/g","Laboratory results for inclusion can be based on:","measurements no more than 90 days old at screening, documented in medical records or"],"whoShouldSkip":["Congenital or hereditary kidney diseases including polycystic kidney disease, autoimmune kidney diseases including glomerulonephritis or congenital urinary tract malformations","Use of any glucagon-like peptide-1 receptor agonist (GLP1 RA) within 30 days prior to screening. This also includes dual agonists containing a GLP1 RA component","Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 60 days prior to the day of screening","Current (or within 90 days) chronic or intermittent haemodialysis or peritoneal dialysis","Combination use of an angiotensin-converting enzyme inhibitor and an angiotensin-II receptor blocker (ARB)"],"whatHappens":"If you join, the listed intervention(s) are Semaglutide. The registry lists allocation as na. The purpose of this clinical study is to find out what happens to kidney and heart health during treatment with a medicine called semaglutide, which is given as an injection under the skin.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 300 people at 26 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.725Z"},{"nctId":"NCT07900451","title":"Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD","officialTitle":"A Multimodal Neurobiological Investigation of Biomarkers Predicting Medication-Induced Adverse Effects in Children With Attention-Deficit/Hyperactivity Disorder","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"National Taiwan University Hospital","sponsorClass":"OTHER","summary":"To build a multimodal model combining neuropsychological, neurophysiological, and metabolomic measures to identify biomarkers predicting MPH-induced adverse effects and their underlying mechanisms, supporting individualized risk assessment in clinical practice.","conditions":["ADHD"],"keywords":[],"interventions":[{"type":"DRUG","name":"methylphenidate"}],"enrollment":90,"startDate":"2026-08-01","completionDate":"2029-07-31","sex":"ALL","minAge":"6 Years","maxAge":"16 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Participants, between the ages of 6 and 16 must meet the DSM-5 criteria for ADHD.\n* At the time of initial evaluation, participants must exhibit a score greater than 3 on the Clinical Global Impressions scale for ADHD Severity (CGI-ADHD-S).\n* Cognitive assessment of participants must demonstrate a Full-Scale Intelligence Quotient (FSIQ) greater than 80.\n\nExclusion Criteria:\n\n* Individuals with comorbid major psychiatric disorders-including autism spectrum disorder (ASD), psychotic disorders, mood disorders, or substance use disorders-will be excluded.\n* Individuals with major neurological conditions, such as epilepsy or other central nervous system disorders, will be excluded.\n* Individuals with serious systemic medical conditions, including diabetes mellitus or cardiovascular disease, will be excluded.\n* Individuals with any prior exposure to pharmacological treatments specifically intended for managing ADHD symptoms will be excluded.","locations":[{"facility":"National Taiwan University Hospital","city":"Taipei","state":"Taiwan","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chi-Yung Shang, MD, PhD","phone":"+886-2-23123456","email":"cyshang@ntu.edu.tw"}],"primaryOutcomes":["Questionnaire","Diagnostic interview","ADHD symptoms"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["taipei-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: testing methylphenidate for ADHD","inPlainEnglish":"To build a multimodal model combining neuropsychological, neurophysiological, and metabolomic measures to identify biomarkers predicting MPH-induced adverse effects and their underlying mechanisms, supporting individualized risk assessment in clinical practice.","whoItsFor":["Ages 6 Years to 16 Years","Participants, between the ages of 6 and 16 must meet the DSM-5 criteria for ADHD","At the time of initial evaluation, participants must exhibit a score greater than 3 on the Clinical Global Impressions scale for ADHD Severity (CGI-ADHD-S)","Cognitive assessment of participants must demonstrate a Full-Scale Intelligence Quotient (FSIQ) greater than 80"],"whoShouldSkip":["Individuals with comorbid major psychiatric disorders-including autism spectrum disorder (ASD), psychotic disorders, mood disorders, or substance use disorders-will be excluded","Individuals with major neurological conditions, such as epilepsy or other central nervous system disorders, will be excluded","Individuals with serious systemic medical conditions, including diabetes mellitus or cardiovascular disease, will be excluded","Individuals with any prior exposure to pharmacological treatments specifically intended for managing ADHD symptoms will be excluded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 90 people at Taipei. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.648Z"},{"nctId":"NCT07900672","title":"Register for Medical Data, Functional Scales, and Care Outcomes in ALS, SMA, and Other Motor System Disorders","officialTitle":"Register Zur Erfassung Medizinischer Daten, Funktioneller Skalen Und Von Verlaufsparametern in Der Hilfsmittel-, Heilmittel-, Beatmungs-, Ernährungs-, Medikamenten- Und Pflegeversorgung Von Patienten Mit Amyotropher Lateralsklerose (ALS), Spinaler Muskelatrophie (SMA) Und Anderen Motorischen Systemerkrankungen","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ambulanzpartner Soziotechnologie APST GmbH","sponsorClass":"INDUSTRY","summary":"This observational registry collects existing medical and routine care data from people with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and other motor system disorders. The registry includes information about disease course, functional abilities, medications, medical devices, therapeutic services, nutrition, breathing support, and nursing care. It may also include patients' assessments of their treatment and care.\n\nThe main goal is to describe how people with these conditions are treated and supported in routine clinical practice. The collected data will be used to study care delivery, patient outcomes, and changes in care over time. The findings may help answer research questions and support the future development of treatment standards and clinical care guidelines.\n\nThis registry does not require any additional medical, nursing, or therapeutic intervention. It uses data generated during routine care and may include information reported by patients or a person authorized by them. The registry is operated by Ambulanzpartner Soziotechnologie APST GmbH in cooperation with Charité - Universitätsmedizin Berlin.","conditions":["ALS (Amyotrophic Lateral Sclerosis)","SMA - Spinal Muscular Atrophy","Spinal Cord Diseases","Central Nervous System Diseases","Nervous System Diseases","Motor Neuron Disease","Neurodegenerative Diseases","TDP-43 Proteinopathies","Neuromuscular Diseases (NMD)","Proteostasis Deficiencies","Metabolic Diseases","Nutritional and Metabolic Diseases","Charcot-Marie-Tooth Disease Type 1F"],"keywords":["Registry","Motoneuron diseases","ALS Registry","SMA Registry","ALS medication and care registry","SMA medication and care registry","NfL","Neurofilament light chain","ALSFRS-R","ALS-App","ALS","APST"],"interventions":[{"type":"OTHER","name":"Standard of Care (Investigator Choice)"}],"enrollment":2000,"startDate":"2026-10-01","completionDate":"2035-12-31","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 18 and over\n* Diagnosis of amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorders\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Withdrawal of informed consent","locations":[{"facility":"Charité - Universitätsmedizin Berlin; Charité Centrum für Neurologie, Neurochirurgie und Psychiatrie; Ambulanz für ALS, SMA und andere Motoneuronerkrankungen","city":"Berlin","state":"State of Berlin","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Marie-Therese Henke","phone":"","email":"m.henke@ambulanzpartner.de"}],"primaryOutcomes":["Number and Percentage of Participants Receiving Each Type of Routine Care Intervention at Enrollment"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["berlin-germany"],"enrichment":{"headline":"Not a traditional drug phase: Standard of Care (Investigator Choice) for ALS (Amyotrophic Lateral Sclerosis)","inPlainEnglish":"This watch-and-measure (no experimental treatment required) registry collects existing medical and routine care data from people with amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), and other motor system disorders. The registry includes information about disease course, functional abilities, medications, medical devices, therapeutic services, nutrition, breathing support, and nursing care.","whoItsFor":["Patients aged 18 and over","Diagnosis of amyotrophic lateral sclerosis (ALS), spinal muscular atrophy (SMA), or another motor system disorders"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,000 people at Berlin. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.604Z"},{"nctId":"NCT07900685","title":"A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation","officialTitle":"A Comparison of Pulsed Field Ablation (PFA) vs Cryoablation for Atrial Fibrillation Under Deep Sedation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"East Sussex Healthcare NHS Trust","sponsorClass":"OTHER","summary":"Pulsed Field Ablation (PFA) has created a 'paradigm shift' within cardiac electrophysiology and the initial experience demonstrates that PFA is safe, rapid and effective compared to both radiofrequency ablation and cryoablation in atrial fibrillation (AF). Presently, AF ablation procedures in the UK using PFA are routinely performed using general anaesthetic (GA) support requiring an anaesthetist and ODP being present in all procedures. This need significantly limits the ability to use PFA technology to perform AF ablations, particularly in centres that have limited availability of GA provision.\n\nThe need for GA also leads to extended patient recovery time post procedure which impacts patient throughput and has the potential to reduce hospital bed availability. The need for GA and the potential to limit patient throughput has negative implications for all hospitals in terms of cost. PFA procedures performed elsewhere in Europe use deep sedation with IV propofol led by the ablating physician, but this is not permitted in the UK and still requires the presence of an anaesthetist.\n\nThe investigators will aim to evaluate if AF ablation using PFA is feasible during spontaneous respiration without the use of propofol. The investigators will conduct a non-randomized study comparing AF ablation using PFA vs cryoballoon under deep sedation - aiming to demonstrate that \\>75% of patients can complete the PFA protocol under deep sedation without conversion to cryoballoon (due to patient intolerance). The principal aim of the study is therefore not to demonstrate superiority or comparative efficacy of one ablation modality over another but rather the ability and feasibility to deliver pulsed field ablation under deep sedation. The use of cryoablation serves as a benchmark comparator to contextualise procedural and sedation-related observations.","conditions":["Atrial Fibrillation (AF)"],"keywords":["ablation","atrial fibrillation","pulsed field ablation"],"interventions":[{"type":"DEVICE","name":"Catheter ablation"},{"type":"DRUG","name":"Deep sedation with midazolam and fentanyl or midazolam and remifentanil"},{"type":"DRUG","name":"Sedation with midazolam and fentanyl"}],"enrollment":60,"startDate":"2026-10-19","completionDate":"2028-04-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with paroxysmal or persistent AF requiring a clinically-indicated AF ablation\n* Age \\>18 years old\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Patients with a BMI \\>35\n* Any patient with a history of airway issues/Obstructive sleep apnoea/ obesity hypoventilation syndrome\n* Significant acid reflux or presence of a large hiatus hernia\n* Lack of capacity to give informed consent\n* Unable to lie flat for a minimum of 45 mins","locations":[{"facility":"Eastbourne DGH","city":"Eastbourne","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jo-Anne Taylor","phone":"0300 13 14 500","email":"esh-tr.researchanddevelopment@nhs.net"}],"primaryOutcomes":["Percentage of patients able to complete protocol with pulsed field ablation without conversion to cryoablaton"],"hasResults":false,"conditionSlugs":["als","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["eastbourne-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Deep sedation with midazolam and fentanyl or midazolam and remifentanil for Atrial Fibrillation (AF)","inPlainEnglish":"Pulsed Field Ablation (PFA) has created a 'paradigm shift' within cardiac electrophysiology and the initial experience demonstrates that PFA is safe, rapid and effective compared to both radiofrequency ablation and cryoablation in atrial fibrillation (AF). Presently, AF ablation procedures in the UK using PFA are routinely performed using general anaesthetic (GA) support requiring an anaesthetist and ODP being present in all procedures.","whoItsFor":["Ages 18 Years to any","Patients with paroxysmal or persistent AF requiring a clinically-indicated AF ablation"],"whoShouldSkip":["Patients with a body-mass index (BMI) \\>35","Any patient with a history of airway issues/Obstructive sleep apnoea/ obesity hypoventilation syndrome","Significant acid reflux or presence of a large hiatus hernia","Unable to lie flat for a minimum of 45 mins"],"whatHappens":"If you join, the listed intervention(s) are Catheter ablation, Deep sedation with midazolam and fentanyl or midazolam and remifentanil, or Sedation with midazolam and fentanyl. The registry lists allocation as randomized. Pulsed Field Ablation (PFA) has created a 'paradigm shift' within cardiac electrophysiology and the initial experience demonstrates that PFA is safe, rapid and effective compared to both radiofrequency ablation and cryoablation in atrial fibrillation (AF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Eastbourne. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.748Z"},{"nctId":"NCT07900893","title":"Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium: Study 3","officialTitle":"Cognitive Neurocomputational Task Reliability and Clinical Applications Consortium","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Washington University School of Medicine","sponsorClass":"OTHER","summary":"In Study 3, all tasks and models from Aim 1 will be evaluated in a large community sample of online participants recruited through Prolific.\n\nAim 3 will establish 1) requirements for testing computational algorithms in population-based samples, 2) whether task length is optimal, and 3) whether computational parameters help predict psychopathology (hallucinations and delusions in particular) in the general population, and how these predictors may be impacted by demographic variables, such as race, ethnicity, gender, age and other social determinants of health.\n\nParticipant demographics will be matched to the U.S. Census 2023 American Community Survey (ACS) data release (updated as available). MPI MacDonald has successfully recruited large online samples for over a decade.\n\nSpecifically, researchers will recruit two samples of n=2,000 to preregister hypotheses and then n=3,000 to independently confirm those hypotheses. Multiple methods will affirm the highest quality human self-report and behavioral data for online samples.\n\nResearchers use Prolific, which is known for high quality research participation, maintaining low levels of bots through strategies such as requiring a photo ID and a waiting period. Second, inclusion criteria will require an approval rating of 90-100% from previous researchers. Participants will complete three sessions, each limited to \\~60 min to avoid burnout.","conditions":["Schizophrenia / Schizoaffective Disorder","SCHIZOPHRENIA 1 (Disorder)","Healthy Adult"],"keywords":["schizophrenia","schizo-affective","healthy controls"],"interventions":[{"type":"BEHAVIORAL","name":"Motion Perception Task"},{"type":"BEHAVIORAL","name":"Sine Wave Speech Task"},{"type":"BEHAVIORAL","name":"Volatility Task"},{"type":"BEHAVIORAL","name":"Choice Probabilistic Reversal Task"},{"type":"BEHAVIORAL","name":"Kamin Blocking Task"},{"type":"BEHAVIORAL","name":"Minnesota Trust Game"},{"type":"BEHAVIORAL","name":"Dynamic Trust Game"}],"enrollment":10000,"startDate":"2026-12-01","completionDate":"2031-06-30","sex":"ALL","minAge":"18 Years","maxAge":"59 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Residents of the U.S.\n* between 18-59 years of age\n\nExclusion Criteria:\n\n* Resides outside of U.S.\n* under 18 or over 59 years of age","locations":[{"facility":"University of Minnesota","city":"Minneapolis","state":"Minnesota","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Washington University","city":"St Louis","state":"Missouri","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Deanna Barch, PhD","phone":"314-935-8729","email":"dbarch@wustl.edu"}],"primaryOutcomes":["Motion Perception Task Performance","Sine Wave Speech Task Performance","Volatility Task Performance","Choice Probabilistic Reversal Performance Task","Kamin Blocking Task Performance","Minnesota Trust Game Performance","Dynamic Trust Game Performance"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["minneapolis-minnesota","st-louis-missouri"],"enrichment":{"headline":"Not a traditional drug phase: Motion Perception Task for Schizophrenia / Schizoaffective Disorder","inPlainEnglish":"In Study 3, all tasks and models from Aim 1 will be evaluated in a large community sample of online participants recruited through Prolific. Aim 3 will establish 1) requirements for testing computational algorithms in population-based samples, 2) whether task length is optimal, and 3) whether computational parameters help predict psychopathology (hallucinations and delusions in particular) in the general population, and how these predictors may be impacted by demographic variables, such as race, ethnicity, gender, age and other social determinants of health.","whoItsFor":["Ages 18 Years to 59 Years","Residents of the U.S","between 18-59 years of age"],"whoShouldSkip":["Resides outside of U.S","under 18 or over 59 years of age"],"whatHappens":"If you join, the listed intervention(s) are Motion Perception Task, Sine Wave Speech Task, or Volatility Task. The registry lists allocation as na. In Study 3, all tasks and models from Aim 1 will be evaluated in a large community sample of online participants recruited through Prolific.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10,000 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.037Z"},{"nctId":"NCT07901335","title":"KLF4 Epigenetic Modulation","officialTitle":"KLF4 Epigenetic Modulation During Polyps-adenoma Progression","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Azienda USL Reggio Emilia - IRCCS","sponsorClass":"OTHER_GOV","summary":"The study investigates the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. Quantitative KLF4 methylation will be assessed in colorectal tissue samples obtained during routine colonoscopy, together with KLF4 gene expression and its correlation with methylation status in matched tissue samples. The study will also evaluate quantitative and site-specific molecular approaches for the assessment of KLF4 methylation.","conditions":["KLF4 Methylation","Epigenetic"],"keywords":["colorectal cancer","gene expression","colorectal polyps","colorectal tissue"],"interventions":[],"enrollment":170,"startDate":"2026-10-30","completionDate":"2027-07","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients undergoing routine colonoscopy\n* \\> 18 years of age\n* Diagnosed by S.C. Anatomia Patologica, AUSL-IRCCS Reggio Emilia\n\nExclusion Criteria:\n\n* Concomitant diagnosis of colorectal carcinoma","locations":[{"facility":"Azienda USL IRCCS di Reggio Emilia","city":"Reggio Emilia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["KLF4 DNA methylation"],"hasResults":false,"conditionSlugs":["colorectal-cancer","als"],"drugSlugs":[],"locationSlugs":["reggio-emilia-italy"],"enrichment":{"headline":"KLF4 Epigenetic Modulation","inPlainEnglish":"The study investigates the epigenetic regulation of KLF4 during the progression from colorectal polyps to adenomas and carcinomas. Quantitative KLF4 methylation will be assessed in colorectal tissue samples obtained during routine colonoscopy, together with KLF4 gene expression and its correlation with methylation status in matched tissue samples.","whoItsFor":["Ages 18 Years to any","Patients undergoing routine colonoscopy","Diagnosed by S.C. Anatomia Patologica, AUSL-IRCCS Reggio Emilia"],"whoShouldSkip":["Concomitant diagnosis of colorectal carcinoma"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 170 people at Reggio Emilia. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.058Z"},{"nctId":"NCT07901777","title":"Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity","officialTitle":"Comparison of Two-Year Weight-Loss Effectiveness of GLP-1 Receptor Agonists and Laparoscopic Sleeve Gastrectomy in the Treatment of Obesity: An Ambispective Propensity Score-Matched Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Yuzuncu Yil University","sponsorClass":"OTHER","summary":"This observational study will compare weight loss over two years in adults receiving GLP-1 receptor agonist medications with weight loss in adults who previously underwent laparoscopic sleeve gastrectomy, an operation that reduces the size of the stomach.\n\nAdults starting GLP-1 medications as part of their usual care will be followed for 24 months. Their results will be compared with existing medical records of adults who underwent sleeve gastrectomy at the same center. Treatment decisions will be made by patients and their treating clinicians as part of routine care, rather than assigned by the study.\n\nThe main outcome is the percentage of starting body weight lost at 24 months. The study will also assess weight changes at earlier visits, medication side effects, treatment continuation and reasons for stopping treatment, and changes in weight-related health conditions. The groups will be matched using baseline characteristics to make the comparison more balanced.","conditions":["Obesity & Overweight"],"keywords":["Obesity","Weight Loss","GLP-1 Receptor Agonists","Laparoscopic Sleeve Gastrectomy","Adverse Events"],"interventions":[{"type":"DRUG","name":"GLP-1 Receptor Agonist Therapy"},{"type":"PROCEDURE","name":"Laparoscopic Sleeve Gastrectomy"}],"enrollment":200,"startDate":"2026-09-15","completionDate":"2028-09-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nGLP-1 Receptor Agonist Cohort:\n\n* Age 18 years or older at treatment initiation.\n* Initiation of a GLP-1 receptor agonist for obesity or overweight as part of routine clinical care.\n* Available baseline height and body weight measurements.\n* Willingness to attend at least one follow-up assessment.\n* Ability to comply with the center's standard follow-up program.\n* Provision of written informed consent.\n\nLaparoscopic Sleeve Gastrectomy Cohort:\n\n* Age 18 years or older at surgery.\n* Primary laparoscopic sleeve gastrectomy for obesity performed at the study center between January 1, 2020, and January 1, 2026.\n* Available preoperative height, body weight, and body mass index measurements.\n* Available demographic and baseline clinical data.\n* At least one documented postoperative body weight measurement. Availability of a 24-month weight measurement is preferred for the primary comparison.\n\nExclusion Criteria:\n\nBoth Cohorts:\n\n* Bariatric or metabolic surgery before the index treatment.\n* Revisional bariatric surgery as the index treatment.\n* Active malignancy or a serious systemic disease substantially affecting body weight.\n* Pregnancy or breastfeeding at the index treatment.\n* Uncontrolled endocrine disease that may cause weight loss.\n* Missing baseline height or body weight measurements.\n* Recent participation in another intensive weight-loss program before the index treatment.\n* Concurrent use of another anti-obesity treatment that could substantially affect study outcomes.\n* Inability to reliably verify study data.\n\nGLP-1 Receptor Agonist Cohort:\n\n* Short-term GLP-1 receptor agonist use for an indication other than weight management.\n* Medication prescribed but never administered.\n\nLaparoscopic Sleeve Gastrectomy Cohort:\n\n* Sleeve gastrectomy performed concurrently with another bariatric procedure.\n* Sleeve gastrectomy performed for an indication other than primary obesity treatment.","locations":[{"facility":"Yüzüncü Yıl University","city":"Van","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Sebahattin Çelik","phone":"+90 505 705 79 57","email":"s.celik@yyu.edu.tr"}],"primaryOutcomes":["Percentage of Total Body Weight change at 24 Months"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":[],"locationSlugs":["van-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: testing GLP-1 Receptor Agonist Therapy for Obesity & Overweight","inPlainEnglish":"This watch-and-measure (no experimental treatment required) study will compare weight loss over two years in adults receiving GLP-1 receptor agonist medications with weight loss in adults who previously underwent laparoscopic sleeve gastrectomy, an operation that reduces the size of the stomach. Adults starting GLP-1 medications as part of their usual care will be followed for 24 months.","whoItsFor":["Ages 18 Years to any","GLP-1 Receptor Agonist Cohort:","Age 18 years or older at treatment initiation","Initiation of a GLP-1 receptor agonist for obesity or overweight as part of routine clinical care","Available baseline height and body weight measurements","Willingness to attend at least one follow-up assessment","Ability to comply with the center's standard follow-up program","Laparoscopic Sleeve Gastrectomy Cohort:"],"whoShouldSkip":["Bariatric or metabolic surgery before the index treatment","Revisional bariatric surgery as the index treatment","Active malignancy or a serious systemic disease substantially affecting body weight","Pregnancy or breastfeeding at the index treatment","Uncontrolled endocrine disease that may cause weight loss","Missing baseline height or body weight measurements","Recent participation in another intensive weight-loss program before the index treatment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at Van. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.721Z"},{"nctId":"NCT07902375","title":"Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers","officialTitle":"Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Universiteit Antwerpen","sponsorClass":"OTHER","summary":"The goal of the MYSSELF (Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers) study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison. The study will explore whether these markers could help improve earlier and less invasive detection of gynecological cancers in the future.","conditions":["Gynaecological Cancers","Ovarian Cancer","Endometrial Cancer","Vulvar Cancer","Vaginal Cancer","Postmenopausal Bleeding","Early Detection of Cancer"],"keywords":["Biomarkers","Self-sampling","First-void urine","Vaginal self-sample","Screening"],"interventions":[{"type":"DEVICE","name":"Colli-Pee 20 mL device with UCM"},{"type":"DEVICE","name":"Evalyn Brush"}],"enrollment":730,"startDate":"2026-06-19","completionDate":"2032-12-31","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Individuals having female genital organs, regardless of their gender identity.\n* 18 years old or older at the time of signing the informed consent form.\n* Diagnosed with either endometrial, ovarian, vulvar, or vaginal cancer irrespective of stage; diagnosed with one of their precursor lesions; or individuals with postmenopausal bleeding.\n* Has not started any form of cancer treatment prior to study enrolment.\n* Written informed consent must be obtained from each participant.\n* The participant is able to understand the information brochure and what the study is about.\n\nExclusion Criteria:\n\n* Individuals that underwent hysterectomy or ovariectomy.\n* Pregnant individuals or 6 weeks post-partum.\n* Treatment for endometrial, ovarian, vulvar, or vaginal (pre-)cancer in the last 6 months before participation in the study.\n* Participating in another interventional clinical study (where, e.g., a medical device, drug, or vaccine is evaluated) at the same time as participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.\n* Unable to give informed consent.\n* Participants with a history or current evidence of any condition or abnormality that might confound the results of the study, or when it is not in the best interest of the participant to participate, in the opinion of the investigator.\n\nExclusion criteria related to blood withdrawal:\n\n* The participant has severe anemia.\n* The participant received a blood transfusion two weeks before sample collection.","locations":[{"facility":"University Hospital of Antwerp (UZA)","city":"Edegem","state":"Antwerp","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tine Pinxteren, MSc","phone":"476014843","email":"tine.pinxteren@uantwerpen.be"}],"primaryOutcomes":["Number and overview of biomarkers associated with the presence of gynecological (pre-)cancers"],"hasResults":false,"conditionSlugs":["ovarian-cancer","endometrial-cancer"],"drugSlugs":[],"locationSlugs":["edegem-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Colli-Pee 20 mL device with UCM for Gynaecological Cancers","inPlainEnglish":"The goal of the MYSSELF (Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers) study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding. Samples collected by clinicians from the cervix or vulva, as well as blood and tissue samples, will be used for comparison.","whoItsFor":["Ages 18 Years to any","Women only","Individuals having female genital organs, regardless of their gender identity","Diagnosed with either endometrial, ovarian, vulvar, or vaginal cancer irrespective of stage; diagnosed with one of their precursor lesions; or individuals with postmenopausal bleeding","Has not started any form of cancer treatment prior to study enrolment"],"whoShouldSkip":["Individuals that underwent hysterectomy or ovariectomy","Pregnant individuals or 6 weeks post-partum","Treatment for endometrial, ovarian, vulvar, or vaginal (pre-)cancer in the last 6 months before participation in the study","Participating in another treatment clinical study (where, e.g., a medical device, drug, or vaccine is evaluated) at the same time as participating in this study. Participation in another watch-and-measure (no experimental treatment required) or low-treatment clinical study at the same time is allowed","Participants with a history or current evidence of any condition or abnormality that might confound the results of the study, or when it is not in the best interest of the participant to participate, in the opinion of the investigator"],"whatHappens":"If you join, the listed intervention(s) are Colli-Pee 20 mL device with UCM, or Evalyn Brush. The registry lists allocation as na. The goal of the MYSSELF (Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers) study is to investigate which biological markers (i.e., (epi)genetic biomarkers) found in self-collected samples, such as first-void urine and vaginal samples, are linked to the presence of endometrial, ovarian, vulvar, or vaginal (pre-)cancer or to postmenopausal bleeding.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 730 people at Edegem. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.180Z"},{"nctId":"NCT07902518","title":"Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations","officialTitle":"The Use of Theta-Burst Transcranial Magnetic Stimulation in the Treatment of Persistent Auditory Hallucinations: A Pilot Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Ciusss de L'Est de l'Île de Montréal","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether theta-burst transcranial magnetic stimulation (TBS), a non-invasive brain stimulation technique, can help reduce persistent auditory verbal hallucinations (hearing voices) in adults with psychotic disorders who have not responded adequately to antipsychotic medications.\n\nThe main questions it aims to answer are:\n\n* Does theta-burst stimulation reduce the severity of auditory verbal hallucinations?\n* Does theta-burst stimulation improve other psychiatric symptoms, including depressive symptoms and insight into illness?\n* How well do participants tolerate this treatment, and what side effects do they experience?\n\nAll participants will receive active theta-burst stimulation. There is no placebo or comparison group.\n\nParticipants will:\n\n* Complete an initial assessment of their mental health, symptoms, and medical history.\n* Receive 20 brain stimulation sessions over two consecutive weeks, with two sessions per day on weekdays.\n* Complete follow-up assessments approximately one week and one month after treatment to evaluate changes in symptoms and overall functioning.\n* Report any side effects experienced during treatment and follow-up.","conditions":["Auditory Verbal Hallucinations","Schizophrenia","Schizoaffective Disorder","Psychotic Disorders"],"keywords":["Treatment-Resistant Auditory Hallucinations","Auditory Verbal Hallucinations","Theta-Burst Stimulation","Transcranial Magnetic Stimulation","Repetitive Transcranial Magnetic Stimulation","Continuous Theta-Burst Stimulation","Intermittent Theta-Burst Stimulation","Schizophrenia","Psychosis","Neuromodulation"],"interventions":[{"type":"DEVICE","name":"Theta-Burst Transcranial Magnetic Stimulation (TBS)"}],"enrollment":12,"startDate":"2025-09-10","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosis of a schizophrenia-spectrum disorder or bipolar disorder with psychotic symptoms.\n* Presence of persistent auditory verbal hallucinations with persecutory content.\n* Auditory verbal hallucinations s that have not responded to ≥2 antipsychotic trials, each lasting more than 6 weeks, with daily chlorpromazine-equivalent doses of ≥600 mg and ≥80% of doses taken.\n* Stable pharmacological treatment for at least two months before enrollment.\n\nExclusion Criteria:\n\n* History of epilepsy or seizures.\n* Neurological disorders that may interfere with the study or increase the risks associated with transcranial magnetic stimulation.\n* Substance use disorder within the previous six months.\n* Electroconvulsive therapy (ECT) within the previous six months.\n* Any other contraindication to transcranial magnetic stimulation.","locations":[{"facility":"Institut universitaire en santé mentale de Montréal","city":"Montreal","state":"Quebec","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Naomi White, Msc","phone":"514-887-3401","email":"naomi.white@umontreal.ca"}],"primaryOutcomes":["Change in Auditory Hallucination Severity (PSYRATS-AH)"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["montreal-canada"],"enrichment":{"headline":"Not a traditional drug phase: Theta-Burst Transcranial Magnetic Stimulation (TBS) for Auditory Verbal Hallucinations","inPlainEnglish":"The goal of this clinical trial is to learn whether theta-burst transcranial magnetic stimulation (TBS), a non-invasive brain stimulation technique, can help reduce persistent auditory verbal hallucinations (hearing voices) in adults with psychotic disorders who have not responded adequately to antipsychotic medications. The main questions it aims to answer are: * Does theta-burst stimulation reduce the severity of auditory verbal hallucinations?","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Diagnosis of a schizophrenia-spectrum disorder or bipolar disorder with psychotic symptoms","Presence of persistent auditory verbal hallucinations with persecutory content","Auditory verbal hallucinations s that have not responded to ≥2 antipsychotic trials, each lasting more than 6 weeks, with daily chlorpromazine-equivalent doses of ≥600 mg and ≥80% of doses taken","Stable pharmacological treatment for at least two months before enrollment"],"whoShouldSkip":["History of epilepsy or seizures","Neurological disorders that may interfere with the study or increase the risks associated with transcranial magnetic stimulation","Substance use disorder within the previous six months","Electroconvulsive therapy (ECT) within the previous six months","Any other contraindication to transcranial magnetic stimulation"],"whatHappens":"If you join, the listed intervention(s) are Theta-Burst Transcranial Magnetic Stimulation (TBS). The registry lists allocation as na. The goal of this clinical trial is to learn whether theta-burst transcranial magnetic stimulation (TBS), a non-invasive brain stimulation technique, can help reduce persistent auditory verbal hallucinations (hearing voices) in adults with psychotic disorders who have not responded adequately to antipsychotic medications.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 12 people at Montreal. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.045Z"},{"nctId":"NCT07902622","title":"Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus","officialTitle":"Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Foundation University Islamabad","sponsorClass":"OTHER","summary":"Systemic lupus erythematosus (SLE) is a complex autoimmune disorder that affects individuals globally, yet there is a significant lack of data regarding its prevalence and management, particularly in Asian populations like Pakistan. To address this gap, we are initiating a groundbreaking project to establish a Lupus Registry in Pakistan.\n\nOur aim is to gain a better understanding of how SLE presents and progresses within the Pakistani population. By collecting detailed information on we hope to provide valuable insights that can tailor diagnostic and therapeutic approaches to suit the local context.\n\nThis project will enroll adult SLE patients initially from Fauji Foundation Hospital Rawalpindi, with plans to expand to other centers nationwide. Trained healthcare professionals will collect data through structured protocol as outlined in detailed project description. Through rigorous data collection and analysis, including the use of validated instruments and statistical methods, we aim to delineate clinical features, disease severity, treatment patterns, outcomes, and factors influencing these parameters. Ethical approval and informed consent will be obtained to ensure the protection of patients' rights and appropriate data usage.\n\nThis registry will be a crucial step toward addressing the unique challenges faced by SLE patients in our population. Through collaboration and data-driven insights, we hope to pave the way for more personalized and effective healthcare interventions in the future.","conditions":["SLE - Systemic Lupus Erythematosus"],"keywords":["SLE","Disease outcome","Lupus nephritis","neuropsychiatric","SLEDAI"],"interventions":[{"type":"OTHER","name":"no active ingredient"}],"enrollment":3000,"startDate":"2025-03-01","completionDate":"2036-05-01","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- All patients presenting with SLE diagnosed by phyician and fulfilling SLICC2012 or EULAR/ACR2019 criteria.\n\nExclusion Criteria:\n\n\\- SLE patient who defers informed consent.","locations":[{"facility":"Fauji Foundation Hospital, Rawalpindi","city":"Rawalpindi","state":"Punjab Province","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dr. Shahida Perveen, FCPS, Rheumatology","phone":"03325235661","email":"shahida.perveen@fui.edu.pk"},{"name":"Dr. Babur Salim, FCPS Rehumatology","phone":"03335107227","email":"babursalim@yahoo.com"}],"primaryOutcomes":["Characterisation of SLE phenotype in indigenous poputation"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["rawalpindi-pakistan"],"enrichment":{"headline":"Not a traditional drug phase: no active ingredient for SLE - Systemic Lupus Erythematosus","inPlainEnglish":"Systemic lupus erythematosus (SLE) is a complex autoimmune disorder that affects individuals globally, yet there is a significant lack of data regarding its prevalence and management, particularly in Asian populations like Pakistan. To address this gap, we are initiating a groundbreaking project to establish a Lupus Registry in Pakistan.","whoItsFor":["\\- All patients presenting with SLE diagnosed by phyician and fulfilling SLICC2012 or EULAR/ACR2019 criteria"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at Rawalpindi. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.281Z"},{"nctId":"NCT07903168","title":"Why Do People With Epilepsy Get More Infections?","officialTitle":"Epilepsy, Immune Dysfunction and Risk of Infection Study - A Prospective Cohort Study of Immune Dysfunction and Infection Risk With Epilepsy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University of Aberdeen","sponsorClass":"OTHER","summary":"People with epilepsy are predisposed to having seizures (\"fits\"), where abnormal electrical activity in the brain disrupts normal brain functioning. It is a common condition with around 1% of the population of Scotland having this condition. They are treated with anti-seizure medications, drugs which reduce the chance of having seizures.\n\nUnfortunately, people with epilepsy are more likely to have severe infections than those without epilepsy and this is known to increase risk of seizures. The reasons for more severe infections in people with epilepsy are unclear, but one factor may be that anti-seizure medications impair the function of the body's immune system, which fights infection. The investigators' previous work looking at residents in the North-East of Scotland showed a link between these medications and risk of infection.\n\nThe investigators plan to study people being started on antiseizure medications (ASMs) with a new diagnosis of epilepsy and those already on ASMs with an established diagnosis of epilepsy in NHS Grampian. The investigators will compare with people not taking ASMs in a group of people with a single seizure and in a group of people with migraine.\n\nThe investigators will investigate immune function and infection risk with more-detailed information about individual's background, their seizures/epilepsy, other health conditions, and blood tests. The investigators will then do laboratory experiments to determine how ASMs may impair the immune system by looking at the function of types of white blood cells that play an important part in immune functioning.\n\nThe investigators also wish to develop statistical tools which can identify an individual's risk of infection when starting ASMs, based on their demographic, medical and social characteristics, to target closer monitoring/changes in treatment to those with higher risk.\n\nThis research will allow healthcare professionals to provide better individualised care in terms of which medication to use for treatment, what doses to use and whether blood tests to screen for impaired immune function would be helpful. The aim is that this will lead to reduced risk of infections in people with epilepsy, resulting in better outcomes in this condition.","conditions":["Epilepsy","Antiepileptic Drugs","Infection","Immune Dysfunction"],"keywords":["Epilepsy","Antiseizure medications","Infections","Immune dysfunction"],"interventions":[{"type":"DRUG","name":"Antiepileptic Drug"}],"enrollment":500,"startDate":"2026-11-04","completionDate":"2038-05","sex":"ALL","minAge":"16 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adults aged 16 or over\n2. Resident in an area covered by NHS Grampian neurology service\n3. Individuals with:\n\n   1. A diagnosis of first unprovoked (or reflex) seizure; or\n   2. A new diagnosis of epilepsy (at least two unprovoked (or reflex) seizures occurring more than 24 hours apart)); or\n   3. Established diagnosis of epilepsy; or\n   4. A diagnosis of migraine\n4. Able to give informed consent to participate or, if lacking capacity, a reliable Welfare Guardian/Welfare Attorney/Nearest Relative can give consent on behalf of the participant.\n\nDefinition of established epilepsy in this context:\n\n1. The individual was diagnosed with epilepsy prior to the consultation at which the clinician referred them to the research team; or\n2. When a potential participant is identified from a previous clinic consultation, they already have a diagnosis of epilepsy.\n\nExclusion Criteria:\n\n1. Functional (non-epileptic) seizures without epileptic seizures or migraine. If the patient has both epileptic and functional seizures, or migraine and functional seizures, they would be eligible for inclusion, provided they meet the other criteria.\n2. Acute symptomatic seizure(s) without previous or subsequent unprovoked seizure(s) (e.g. due to head trauma, severe infection, significant electrolyte abnormality, alcohol withdrawal) would be an exclusion from the first seizure/epilepsy group.\n3. First seizure group:\n\n   a) Those taking or are planned to be started on antiseizure medication(s)\n4. New diagnosis of epilepsy group:\n\n   1. Those not planned to be started on an antiseizure medication\n   2. Those taking, or are planned to be started on, two or more antiseizure medications\n   3. Those already taking an antiseizure medication at the time of their new diagnosis of epilepsy\n5. Established epilepsy group:\n\n   1. Those taking, or are planned to be started on, two or more antiseizure medications\n   2. Those not taking an antiseizure medication, even if planned to be started on an antiseizure medication\n6. Migraine control group:\n\n   1. Receiving treatment with antiseizure medications; or\n   2. Receiving immunosuppressive\\* treatment for another condition; or\n   3. Medical history of single unprovoked seizure or epilepsy\n\n      * Exclusion due to immunosuppression increasing risk of immune dysfunction. Immunosuppression is not an exclusion criterion for first seizure/epilepsy groups as immunosuppression will be used as a variable for other analyses, including risk prediction analyses.","locations":[{"facility":"Institute of Applied Health Sciences, University of Aberdeen","city":"Aberdeen","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Infections"],"hasResults":false,"conditionSlugs":["migraine","als","epilepsy"],"drugSlugs":[],"locationSlugs":["aberdeen-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Antiepileptic Drug for Epilepsy","inPlainEnglish":"People with epilepsy are predisposed to having seizures (\"fits\"), where abnormal electrical activity in the brain disrupts normal brain functioning. It is a common condition with around 1% of the population of Scotland having this condition.","whoItsFor":["Ages 16 Years to any","Adults aged 16 or over","Resident in an area covered by NHS Grampian neurology service","A diagnosis of first unprovoked (or reflex) seizure; or","A new diagnosis of epilepsy (at least two unprovoked (or reflex) seizures occurring more than 24 hours apart)); or","Established diagnosis of epilepsy; or","A diagnosis of migraine","Definition of established epilepsy in this context:"],"whoShouldSkip":["Functional (non-epileptic) seizures without epileptic seizures or migraine. If the patient has both epileptic and functional seizures, or migraine and functional seizures, they would be eligible for inclusion, provided they meet the other criteria","Acute symptomatic seizure(s) without previous or subsequent unprovoked seizure(s) (e.g. due to head trauma, severe infection, significant electrolyte abnormality, alcohol withdrawal) would be an exclusion from the first seizure/epilepsy group","First seizure group:","a) Those taking or are planned to be started on antiseizure medication(s)","New diagnosis of epilepsy group:","Those not planned to be started on an antiseizure medication","Those taking, or are planned to be started on, two or more antiseizure medications"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at Aberdeen. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.899Z"},{"nctId":"NCT07903246","title":"A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People","officialTitle":"A Prospective Cohort Study of Emotion-Related Disorders","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","sponsorClass":"OTHER","summary":"This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms.\n\nThe study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China. Participants will include people with anxiety disorders, depressive disorders, or bipolar disorder, as well as healthy volunteers for comparison.\n\nParticipants will be followed for 3 years after enrollment, with assessments at baseline and at 1, 6, 12, 18, 24, 30, and 36 months. Study assessments will collect information about symptoms, treatment, daily functioning, and quality of life. Other study data will include biological samples, brain imaging, recordings of brain electrical activity, and measurements from wearable devices and tasks involving speech, facial expressions, and eye movements.\n\nResearchers will examine how these measurements relate to symptoms and changes in health over time. They will also develop and evaluate artificial intelligence models intended to help identify these disorders and predict treatment outcomes, relapse, and suicide or self-harm risk.\n\nThis is an observational study. The researchers will not assign treatments or change participants' treatment as part of the study. Treatments received during routine clinical care will be recorded.","conditions":["Anxiety Disorders","Depressive Disorder","Bipolar Disorder (BD)"],"keywords":["Prospective Cohort Study","Digital Phenotyping","Multimodal Data","Artificial Intelligence","Multi-Omics","Neuroimaging","Electroencephalography","Wearable Devices"],"interventions":[],"enrollment":2690,"startDate":"2026-09-15","completionDate":"2030-12-31","sex":"ALL","minAge":"12 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nGeneral criteria for all groups:\n\n* Age 12 to 55 years, inclusive, of any sex.\n* Education at or above the third-grade primary school level.\n* Voluntary participation with written informed consent. For participants younger than 18 years, written informed consent from a legal guardian and the participant's assent, when capable, are required. For participants with impaired consent capacity, consent will be obtained from the participant and/or legal guardian as specified in the protocol.\n\nAnxiety disorders group:\n\n* Meet DSM-5 diagnostic criteria for one or more anxiety spectrum disorders.\n* Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14.\n* Normal intellectual functioning, vision, and hearing.\n\nDepressive disorders group:\n\n* Meet DSM-5 diagnostic criteria for one or more depressive disorders.\n* Hamilton Depression Rating Scale (HAMD-17) total score of at least 17.\n* Normal intellectual functioning, vision, and hearing.\n\nBipolar disorder group:\n\n* Meet DSM-5 diagnostic criteria for bipolar I or bipolar II disorder.\n* Not currently experiencing a manic episode.\n* Normal intellectual functioning, vision, and hearing.\n\nHealthy control group:\n\n* Normal or corrected-to-normal vision.\n* Good physical health, without serious physical illness or chronic disease.\n* Normal cognitive functioning.\n* No family history of mental illness across three generations on either the maternal or paternal side.\n\nExclusion Criteria:\n\n* The following criteria apply to all groups:\n* Failure to meet the inclusion criteria for the relevant group, or meeting DSM-5 criteria for a mental disorder other than those targeted by this study.\n* Current risk of dangerous behavior, rated as level 2 or above on the dangerousness assessment specified in the protocol.\n* Severe agitation, oppositional behavior, or markedly reduced volition or activity that prevents completion of the assessments.\n* Current or previous organic brain disease, a history of epilepsy, or a history of traumatic brain injury.\n* A history of drug or substance abuse, including tobacco, alcohol, or other psychoactive substances.\n* Cardiovascular, cerebrovascular, respiratory, or neurological disease; infectious disease; other serious physical illness; or a pathological condition that may cause cognitive impairment.\n* Limb disability or inability to make the required button-press responses using the upper limbs.\n* Pregnancy or breastfeeding.\n* Electroconvulsive therapy, transcranial magnetic stimulation, alternating-current or direct-current electrical stimulation, vagus nerve stimulation, or deep brain stimulation within the previous 6 months.\n* Metal implants or other metallic objects that cannot be safely removed and prevent safe magnetic resonance imaging.\n* Red-green color blindness.\n* Any other condition that, in the investigator's judgment, makes participation unsuitable.","locations":[{"facility":"The Second Affiliated Hospital, School of Medicine, Zhejiang University","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ming Zheng, PhD","phone":"+8619550211701","email":"mingzheng17@hotmail.com"}],"primaryOutcomes":["Macro-Averaged Area Under the ROC Curve of the Multimodal Digital Phenotyping-Based Diagnostic Model in the Independent Validation Cohort","Change From Baseline in 17-Item Hamilton Depression Rating Scale (HAMD-17) Score","Change From Baseline in 14-Item Hamilton Anxiety Rating Scale (HAMA-14) Score","Change From Baseline in Bech-Rafaelsen Mania Rating Scale (BRMS) Score in the Bipolar Disorder Group"],"hasResults":false,"conditionSlugs":["als","depression","bipolar-disorder","anxiety"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People","inPlainEnglish":"This study aims to understand how anxiety disorders, depressive disorders, and bipolar disorder change over time and to identify patterns that may help with earlier recognition, diagnosis, and prediction of future symptoms. The study will enroll approximately 2,690 participants aged 12 to 55 years across multiple hospitals in China.","whoItsFor":["Ages 12 Years to 55 Years","General criteria for all groups:","Age 12 to 55 years, inclusive, of any sex","Education at or above the third-grade primary school level","Anxiety disorders group:","Meet DSM-5 diagnostic criteria for one or more anxiety spectrum disorders","Hamilton Anxiety Rating Scale (HAMA-14) total score of at least 14","Normal intellectual functioning, vision, and hearing"],"whoShouldSkip":["The following criteria apply to all groups:","Failure to meet the who can join for the relevant group, or meeting DSM-5 criteria for a mental disorder other than those targeted by this study","Current risk of dangerous behavior, rated as level 2 or above on the dangerousness assessment specified in the protocol","Severe agitation, oppositional behavior, or markedly reduced volition or activity that prevents completion of the assessments","Current or previous organic brain disease, a history of epilepsy, or a history of traumatic brain injury","A history of drug or substance abuse, including tobacco, alcohol, or other psychoactive substances","Cardiovascular, cerebrovascular, respiratory, or neurological disease; infectious disease; other serious physical illness; or a pathological condition that may cause cognitive impairment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,690 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.734Z"},{"nctId":"NCT07903805","title":"Asthma and Primary Arterial Hypertension: an Inflammatory Link?","officialTitle":"Asthma and Primary Arterial Hypertension: an Inflammatory Link?","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"A low-intervention, prospective, experimental study will be conducted with the overall aim of assessing the inflammatory, functional and clinical differences between patients with asthma and those with asthma and hypertension, in order to improve our understanding of asthma and its comorbidities","conditions":["Asthma Bronchial"],"keywords":[],"interventions":[{"type":"OTHER","name":"measurement of inflammatory markers"}],"enrollment":74,"startDate":"2023-12-23","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 and ≤85 years;\n* Diagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines\n* Diagnosis of moderate/severe asthma according to current GINA guidelines and primary arterial hypertension according to current European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines\n* Patients able to collaborate in the required procedures;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* History of asthma exacerbation requiring changing of pharmacological treatment in the previous month.\n* Active smoking status or ex-smoker with Pack/Year major than 10;\n* BMI major than 30 Kg/m2;\n* Pregnancy;\n* Diagnosis of concomitant Chronic Obstructive Pulmonary Disease (COPD); Obstructive Sleep Apnoea Syndrome (OSA); Clinically significant bronchiectasis; Allergic bronchopulmonary aspergillosis (ABPA); Atopic dermatitis;\n* Diagnosis of concomitant Autoimmune Diseases; History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or (Hepatitis C Virus)HCV ;\n* Active significant infection\n* Malignancy, current or within the past 5 years. Suspected malignancy or undefined neoplasms;\n* Cognitive impairment;\n* History of clinically significant chronic heart diseases;","locations":[{"facility":"IRCSS ICS Maugeri Tradate","city":"Tradate","state":"Varese","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dina Visca, Professor","phone":"+39 0331829599","email":"dina.visca@icsmaugeri.it"},{"name":"Francesco Ardesi, Medical doctor","phone":"+39 0331 829599","email":"francesco.ardesi@icsmaugeri.it"}],"primaryOutcomes":["Interleukin 4","Interleukin 5","Interleukin 13","FEV1"],"hasResults":false,"conditionSlugs":["hypertension","asthma"],"drugSlugs":[],"locationSlugs":["tradate-italy"],"enrichment":{"headline":"Not a traditional drug phase: measurement of inflammatory markers for Asthma Bronchial","inPlainEnglish":"A low-intervention, prospective, experimental study will be conducted with the overall aim of assessing the inflammatory, functional and clinical differences between patients with asthma and those with asthma and hypertension, in order to improve our understanding of asthma and its comorbidities","whoItsFor":["Ages 18 Years to 85 Years","Age ≥18 and ≤85 years;","Diagnosis of moderate/severe asthma according to current Global Initiative for Asthma (GINA) guidelines","Diagnosis of moderate/severe asthma according to current GINA guidelines and primary arterial hypertension according to current European Society of Cardiology/European Society of Hypertension (ESC/ESH) guidelines","Patients able to collaborate in the required procedures;"],"whoShouldSkip":["History of asthma exacerbation requiring changing of pharmacological treatment in the previous month","Active smoking status or ex-smoker with Pack/Year major than 10;","body-mass index (BMI) major than 30 Kg/m2;","Diagnosis of concomitant Chronic Obstructive Pulmonary Disease (COPD); Obstructive Sleep Apnoea Syndrome (OSA); Clinically significant bronchiectasis; Allergic bronchopulmonary aspergillosis (ABPA); Atopic dermatitis;","Diagnosis of concomitant Autoimmune Diseases; History of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or (Hepatitis C Virus)HCV ;","Active significant infection","Malignancy, current or within the past 5 years. Suspected malignancy or undefined neoplasms;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 74 people at Tradate. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.352Z"},{"nctId":"NCT07904546","title":"ADBest TREAT Registry","officialTitle":"ADBest-TREAT: A Registry for Patients With Atopic Dermatitis Receiving Systemic, Local, or UV Therapy","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Universitätsklinikum Hamburg-Eppendorf","sponsorClass":"OTHER","summary":"Atopic dermatitis is a chronic inflammatory skin disease associated with intense pruritus, recurrent eczematous lesions, sleep disturbance, and reduced quality of life. The disease may be influenced by genetic factors, environmental triggers, epidermal barrier dysfunction, and immune dysregulation. Patients may experience flares triggered by allergens, infections, dry skin, stress, irritants, or other environmental factors. Atopic dermatitis can also be associated with secondary bacterial or viral skin infections and a substantial burden on daily activities, work productivity, sleep, and psychosocial well-being.TREAT is the German national treatment registry for patients with atopic dermatitis. The registry collects real-world data from routine dermatological care to assess disease course, treatment patterns, disease burden, patient-relevant treatment benefits, and quality of life. Data are collected electronically using physician-completed eCRFs and patient-completed questionnaires at inclusion and follow-up visits. The registry aims to improve understanding of atopic dermatitis real-world care and outcomes in daily clinical practice.","conditions":["Atopic Dermatitis"],"keywords":["Atopic dermatit","eczema","chronic inflammatory skin disease","real-world evidence"],"interventions":[{"type":"DRUG","name":"Abrocitinib"},{"type":"DRUG","name":"Baricitinib"},{"type":"DRUG","name":"Upadacitinib"},{"type":"BIOLOGICAL","name":"Dupilumab"},{"type":"BIOLOGICAL","name":"Lebrikizumab"},{"type":"BIOLOGICAL","name":"Nemolizumab"},{"type":"BIOLOGICAL","name":"Tralokinumab"},{"type":"OTHER","name":"Conventional Systemic Therapy"}],"enrollment":5000,"startDate":"2023-01-01","completionDate":"2032-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age \\>18 years\n* Planned initiation of systemic therapy\n* Clinically confirmed diagnosis of atopic dermatitis\n* Written informed consent after patient education\n\nExclusion Criteria:\n\n* Patient who do not provide written informed consent\n* Patients Younger than 18 years\n* Patients without a clinically confirmed diagnosis of atopic dermatitis\n* Patients for whom systemic therapy is not planned","locations":[{"facility":"Institute for Health Services Research in Dermatology and Nursing, IVDP; University Medical Center Hamburg-Eppendorf,UKE","city":"Hamburg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Matthias Augustin, Prof.Dr.","phone":"+4940741055428","email":"m.augustin@uke.de"}],"primaryOutcomes":["Eczema Area and Severity Index(EASI) score","Dermatology Life Quality Index (DLQI) score"],"hasResults":false,"conditionSlugs":["als","atopic-dermatitis"],"drugSlugs":["dupilumab"],"locationSlugs":["hamburg-germany"],"enrichment":{"headline":"Not a traditional drug phase: testing Abrocitinib for Atopic Dermatitis","inPlainEnglish":"Atopic dermatitis is a chronic inflammatory skin disease associated with intense pruritus, recurrent eczematous lesions, sleep disturbance, and reduced quality of life. The disease may be influenced by genetic factors, environmental triggers, epidermal barrier dysfunction, and immune dysregulation.","whoItsFor":["Ages 18 Years to any","Planned initiation of systemic therapy","Clinically confirmed diagnosis of atopic dermatitis"],"whoShouldSkip":["Patients Younger than 18 years","Patients without a clinically confirmed diagnosis of atopic dermatitis","Patients for whom systemic therapy is not planned"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 5,000 people at Hamburg. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.829Z"},{"nctId":"NCT07905001","title":"A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer","officialTitle":"A Phase 1/1b, First-in-Human, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PRT13722, a KAT6A Protein Degrader, as Monotherapy and in Combination With Endocrine and Targeted Therapy in Adults With Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Prelude Therapeutics Incorporated","sponsorClass":"INDUSTRY","summary":"This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. PRT13722 will be evaluated as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion (RDE) and evaluate preliminary clinical activity.","conditions":["Breast Cancer","Hormone-receptor-positive Breast Cancer","HER2-negative Breast Cancer","HR-positive Breast Cancer","HR+/HER2- Breast Cancer","Locally Advanced Breast Cancer","Metastatic Breast Cancer"],"keywords":["Breast Cancer","Hormone-receptor-positive Breast Cancer","HER2-negative Breast Cancer","HR-positive Breast Cancer","HR+/HER2- Breast Cancer","Locally Advanced Breast Cancer","Locally Advanced or Metastatic HR+/HER2- Breast Cancer","Metastatic Breast Cancer","PRT13722","Abemaciclib","Fulvestrant","Imlunestrant","KAT6A"],"interventions":[{"type":"DRUG","name":"PRT13722"},{"type":"DRUG","name":"Fulvestrant"},{"type":"DRUG","name":"Abemaciclib"},{"type":"DRUG","name":"Imlunestrant"}],"enrollment":242,"startDate":"2026-11-16","completionDate":"2028-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.\n* histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negative breast cancer\n* Disease progression following prior standard therapy and eligible for the assigned study cohort\n* Measurable or evaluable disease per RECIST v1.1\n* Willingness to provide tumor tissue for biomarker analyses\n* Eastern Cooperative Oncology Group performance status of 0-1\n* Negative serum or urine pregnancy test and agree to use highly effective contraception or maintain true abstinence.\n* Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)\n\nExclusion Criteria:\n\n* Untreated, symptomatic, or unstable brain metastases\n* Symptomatic visceral disease at risk of imminent life-threatening complications\n* Uncontrolled infection or significant concurrent medical conditions\n* Clinically significant cardiovascular disease or prolonged QT syndrome\n* Pregnancy or breastfeeding\n* Prior treatment with a KAT6-targeting agent\n* Recent anticancer therapy, radiotherapy, or major surgery\n* Use of prohibited concomitant medications, including strong CYP3A4 inhibitors or inducers, proton pump inhibitors, P-gp inhibitors or inducers, and breast cancer resistance protein inhibitors\n* Participation in another interventional clinical study\n* Any condition that would interfere with study participation or evaluation of study results","locations":[{"facility":"Taylor Cancer Research Center","city":"Maumee","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Study Contact (Please Do Not Disclose Personal Information)","phone":"See Email","email":"clinicaltrials@preludetx.com"}],"primaryOutcomes":["Dose limiting toxicity of PRT13722 (Parts 1A and 2)","Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2)","Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3)"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["maumee-ohio"],"enrichment":{"headline":"Phase 1: testing PRT13722 for Breast Cancer","inPlainEnglish":"This first-in-human, open-label, multicenter study will measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. PRT13722 will be evaluated as this drug alone and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion (RDE) and evaluate preliminary clinical activity.","whoItsFor":["Ages 18 Years to any","Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures","histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negative breast cancer","Disease progression following prior standard therapy and eligible for the assigned study cohort","Measurable or evaluable disease per RECIST v1.1","Willingness to provide tumor tissue for biomarker analyses","Eastern Cooperative Oncology Group performance status of 0-1","Negative serum or urine pregnancy test and agree to use highly effective contraception or maintain true abstinence"],"whoShouldSkip":["Untreated, symptomatic, or unstable brain metastases","Symptomatic visceral disease at risk of imminent life-threatening complications","Uncontrolled infection or significant concurrent medical conditions","Clinically significant cardiovascular disease or prolonged QT syndrome","Pregnancy or breastfeeding","Prior treatment with a KAT6-targeting agent","Recent anticancer therapy, radiotherapy, or major surgery"],"whatHappens":"If you join, the listed intervention(s) are PRT13722, Fulvestrant, or Abemaciclib. The registry lists allocation as randomized. This first-in-human, open-label, multicenter study will measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 242 people at Maumee. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.975Z"},{"nctId":"NCT07905677","title":"Phase 1 Study of VT-101 in Advanced Ovarian Cancer","officialTitle":"A Phase 1 Dose-Finding, Safety, and Preliminary Clinical Activity Study of VT-101 in Advanced Ovarian Cancer","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Michael J. Goodheart","sponsorClass":"OTHER","summary":"This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study. Secondary and exploratory objectives include evaluation of preliminary antitumor activity and characterization of treatment-related effects in participants with limited standard treatment options.","conditions":["Epithelial Ovarian Cancer","Ovarian Cancer"],"keywords":[],"interventions":[{"type":"DRUG","name":"VT-101"}],"enrollment":22,"startDate":"2026-10-26","completionDate":"2029-10-23","sex":"FEMALE","minAge":"18 Years","maxAge":"99 Years","healthyVolunteers":false,"eligibilityRaw":"ELIGIBILITY CRITERIA\n\nInclusion Criteria:\n\n* Female participant\n* Age ≥ 18 years\n* Histologically confirmed advanced, recurrent, or relapsed epithelial ovarian cancer\n* Has received prior standard therapy for ovarian cancer, OR has refused standard therapy, OR is intolerant to standard therapy, OR is not eligible for standard therapy\n* ECOG Performance Status of 0, 1, or 2\n* Adequate bone marrow, liver, and kidney function as defined by the protocol\n* Able to comply with study procedures and provide informed consent\n* For women of childbearing potential: agrees to use protocol-required contraception and meets pregnancy testing requirements\n\nExclusion Criteria (high-level):\n\n* Does not meet the inclusion criteria\n* Medical conditions or laboratory abnormalities that would make study participation unsafe\n* Other protocol-defined exclusions as determined by the investigator\n\nSex:\n\n• Female only\n\nAge:\n\n* 18 years and older\n* No upper age limit specified\n\nHealthy Volunteers:\n\n* No\n* Healthy volunteers are not eligible\n* Participants must have advanced, recurrent, or relapsed epithelial ovarian cancer","locations":[{"facility":"University of Iowa Health Care","city":"Iowa City","state":"Iowa","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael Goodheart, MD","phone":"+1 319 356 2015","email":"michael-goodheart@uiowa.edu"}],"primaryOutcomes":["Number of Participants With Dose-Limiting Toxicities (DLTs)","Overall Response Rate (ORR)"],"hasResults":false,"conditionSlugs":["ovarian-cancer"],"drugSlugs":[],"locationSlugs":["iowa-city-iowa"],"enrichment":{"headline":"Phase 1: testing VT-101 for Epithelial Ovarian Cancer","inPlainEnglish":"This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer. The primary objectives are to assess the safety, tolerability, and pharmacokinetic profile of VT-101 and to identify a recommended dose for further study.","whoItsFor":["Ages 18 Years to 99 Years","Women only","ELIGIBILITY CRITERIA","Histologically confirmed advanced, recurrent, or relapsed epithelial ovarian cancer","Has received prior standard therapy for ovarian cancer, OR has refused standard therapy, OR is intolerant to standard therapy, OR is not eligible for standard therapy","how well you can do daily activities (ECOG score) of 0, 1, or 2","Adequate bone marrow, liver, and kidney function as defined by the protocol","For women of childbearing potential: agrees to use protocol-required contraception and meets pregnancy testing requirements"],"whoShouldSkip":["Does not meet the who can join","Medical conditions or laboratory abnormalities that would make study participation unsafe","Other protocol-defined exclusions as determined by the investigator","No upper age limit specified","Healthy Volunteers:","Healthy volunteers are not eligible","Participants must have advanced, recurrent, or relapsed epithelial ovarian cancer"],"whatHappens":"If you join, the listed intervention(s) are VT-101. The registry lists allocation as na. This Phase 1, open-label study will evaluate VT-101, an investigational small-molecule therapy, in adult women with advanced, recurrent, or relapsed epithelial ovarian cancer.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 22 people at Iowa City. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.164Z"},{"nctId":"NCT07906769","title":"Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models","officialTitle":"Analisi Automatizzata Del Linguaggio Nelle Malattie Neurodegenerative: Applicazione di Modelli di Intelligenza Artificiale","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"This multicenter study aims to characterize the language profiles of patients with various neurodegenerative diseases, including Alzheimer's disease (AD), Primary Progressive Aphasia (PPA), behavioral variant Frontotemporal Dementia (bvFTD), Dementia with Lewy Bodies (DLB), and Parkinson's disease (PD), using artificial intelligence (AI) models. By analyzing speech and language data collected during remote neuropsychological assessments, the researchers intend to identify objective linguistic biomarkers suitable for early and differential diagnosis, overcoming the limitations of traditional, invasive, and costly diagnostic tools. The project will develop and validate an AI-driven pipeline to provide scalable and individualized linguistic profiles, ultimately supporting personalized treatment strategies and improving clinical workflow efficiency in the Italian population.","conditions":["Alzheimer's Disease (AD)","Frontotemporal Dementia (FTD)","Parkinsons Disease (PD)","Lewy Body Dementia"],"keywords":["Neurodegenerative diseases","Automated Speech and language analysis","Artificial intelligence (machine learning)"],"interventions":[{"type":"BEHAVIORAL","name":"Speech and language Test to support clinical diagnosis"}],"enrollment":200,"startDate":"2025-10-20","completionDate":"2028-01-31","sex":"ALL","minAge":"40 Years","maxAge":"90 Years","healthyVolunteers":true,"eligibilityRaw":"Participants with neurodegenerative diseases\n\nInclusion criteria\n\n* Diagnosis of mild cognitive impairment due to Alzheimer's disease (AD), primary progressive aphasia (PPA), behavioral variant frontotemporal dementia (bvFTD), dementia with Lewy bodies (DLB), or Parkinson's disease (PD).\n* Age 40-85 years.\n* Italian native speaker.\n* Able to provide informed consent.\n\nExclusion criteria\n\n* Mini-Mental State Examination (MMSE) score below 15.\n* Other neurological or psychiatric diagnoses, including cerebrovascular disease documented by MRI or CT.\n* Severe, uncorrected hearing or visual impairment.\n* Clinical Dementia Rating (CDR) score above 1.\n\nHealthy controls\n\nInclusion criteria\n\n* Italian native speaker.\n* Matched to the patient groups for age, sex, and education level.\n\nExclusion criteria\n\n* History of systemic, neurological, or psychiatric disease.\n* Substance abuse.\n* Family history of neurodegenerative disease.\n* MMSE score below 27/30.","locations":[{"facility":"Istituti Clinici Scientifici Maugeri IRCCS Bari","city":"Bari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Petronilla Battista, PhD","phone":"+390807814331","email":"petronilla.battista@icsmaugeri.it"},{"name":"Gaia C Santi, PhD","phone":"","email":"gaia.santi@icsmaugeri.it"}],"primaryOutcomes":["Performance of AI-based language analysis in distinguishing diagnostic groups"],"hasResults":false,"conditionSlugs":["alzheimer","parkinson"],"drugSlugs":[],"locationSlugs":["bari-italy"],"enrichment":{"headline":"Not a traditional drug phase: Speech and language Test to support clinical diagnosis for Alzheimer's Disease (AD)","inPlainEnglish":"This multicenter study aims to characterize the language profiles of patients with various neurodegenerative diseases, including Alzheimer's disease (AD), Primary Progressive Aphasia (PPA), behavioral variant Frontotemporal Dementia (bvFTD), Dementia with Lewy Bodies (DLB), and Parkinson's disease (PD), using artificial intelligence (AI) models. By analyzing speech and language data collected during remote neuropsychological assessments, the researchers intend to identify objective linguistic biomarkers suitable for early and differential diagnosis, overcoming the limitations of traditional, invasive, and costly diagnostic tools.","whoItsFor":["Ages 40 Years to 90 Years","Participants with neurodegenerative diseases","Diagnosis of mild cognitive impairment due to Alzheimer's disease (AD), primary progressive aphasia (PPA), behavioral variant frontotemporal dementia (bvFTD), dementia with Lewy bodies (DLB), or Parkinson's disease (PD)","Italian native speaker"],"whoShouldSkip":["Mini-Mental State Examination (MMSE) score below 15","Other neurological or psychiatric diagnoses, including cerebrovascular disease documented by MRI or CT","Severe, uncorrected hearing or visual impairment","Clinical Dementia Rating (CDR) score above 1","Italian native speaker","Matched to the patient groups for age, sex, and education level"],"whatHappens":"If you join, the listed intervention(s) are Speech and language Test to support clinical diagnosis. The registry lists allocation as randomized. This multicenter study aims to characterize the language profiles of patients with various neurodegenerative diseases, including Alzheimer's disease (AD), Primary Progressive Aphasia (PPA), behavioral variant Frontotemporal Dementia (bvFTD), Dementia with Lewy Bodies (DLB), and Parkinson's disease (PD), using artificial intelligence (AI) models.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 200 people at Bari. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.673Z"},{"nctId":"NCT07908160","title":"Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations","officialTitle":"Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Peking University First Hospital","sponsorClass":"OTHER","summary":"In recent years, wearable and contactless devices, including smart rings, smart bands/watches, and smart mattresses, have developed rapidly and can continuously collect multidimensional data such as heart rate, oxygen saturation, respiration, body movement, snoring, body temperature, and environmental parameters. Nevertheless, most current consumer-grade or wellness-oriented devices have not been trained and validated using large polysomnography (PSG)-synchronized reference datasets. Their accuracy, robustness, and interpretability in people with insomnia, obstructive sleep apnea (OSA), and other sleep disorders therefore require systematic evaluation.\n\nLeveraging a multicenter clinical sleep-medicine platform, this study will synchronously collect standard full-night polysomnography (PSG) data, continuous body-temperature data, smart-ring sensor data, contactless sleep-monitoring belt data, and indoor environmental monitoring data from the same participant during the same monitoring night. A clinical sleep database will be established with PSG-derived reference-standard labels, strict temporal synchronization, and multimodal features. The database will support the development, optimization, and validation of sleep-staging and obstructive sleep apnea (OSA)-screening models and will provide a data and modeling foundation for subsequent smart sleep-monitoring products, home-based sleep-health management, and clinically assisted screening applications.","conditions":["Sleep Apnea, Obstructive","Sleep Staging","Screening"],"keywords":[],"interventions":[],"enrollment":1000,"startDate":"2026-08-07","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center.\n\nParticipants must meet all of the following criteria:\n\n1. Aged 18-65 years, of either sex.\n2. Voluntarily agrees to participate and provides written informed consent.\n3. Able to complete standard full-night attended Type I PSG.\n4. Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG.\n5. Able to complete study-related questionnaires and collection of basic information.\n\nStudy Population 2: Recruited healthy volunteers or volunteers at low risk for sleep disorders. Participants must meet all of the following criteria:\n\n1. Aged 18-65 years, of either sex.\n2. Self-reports generally good sleep and no prominent subjective sleep complaints, such as habitual snoring, frequent awakenings with choking or gasping, chronic difficulty initiating or maintaining sleep, or excessive daytime sleepiness; and has no previous clinical diagnosis of sleep apnea, chronic insomnia, or any other sleep disorder.\n3. Has not regularly used sedative-hypnotic medication during the previous month.\n4. Voluntarily agrees to participate and provides written informed consent.\n5. Able to complete standard full-night attended Type I PSG.\n6. Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG.\n7. Able to complete study-related questionnaires and collection of basic information.\n\nExclusion Criteria:\n\n* A participant meeting any of the following criteria will be excluded:\n\n  1. Unable to complete full-night PSG.\n  2. Unable to wear or use the study devices, or has clear intolerance to the devices or adhesive materials.\n  3. Requires continuous positive airway pressure (CPAP), noninvasive ventilation, supplemental oxygen, or another medical device during the night that may significantly interfere with signal acquisition from PSG or the study devices.\n  4. Has persistent atrial fibrillation, a severe or unstable medical condition, significant organ dysfunction, or any condition that substantially affects sleep.\n  5. Has severe cognitive impairment, psychiatric or behavioral abnormalities, or another condition that prevents understanding of the study or cooperation with study procedures.\n  6. Is considered by the investigator to be unsuitable for completion of overnight monitoring.\n  7. Has any other condition that, in the investigator's judgment, makes participation inappropriate.","locations":[{"facility":"Peking University First Hospiatl","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cheng Zhang, Dr.","phone":"86-10-13611035724","email":"zhangcheng033@163.com"}],"primaryOutcomes":["The sensitivity and specificity of the OSA-screening model","The Cohen's kappa coefficient and overall accuracy of Sleep-staging model"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive…","inPlainEnglish":"In recent years, wearable and contactless devices, including smart rings, smart bands/watches, and smart mattresses, have developed rapidly and can continuously collect multidimensional data such as heart rate, oxygen saturation, respiration, body movement, snoring, body temperature, and environmental parameters. Nevertheless, most current consumer-grade or wellness-oriented devices have not been trained and validated using large polysomnography (PSG)-synchronized reference datasets.","whoItsFor":["Ages 18 Years to 65 Years","Study Population 1: Individuals scheduled to undergo standard full-night PSG at a participating center","Participants must meet all of the following criteria:","Aged 18-65 years, of either sex","Able to complete standard full-night attended Type I PSG","Able to wear a smart ring and a continuous body-temperature patch and to use a contactless sleep-monitoring belt concurrently during PSG","Able to complete study-related questionnaires and collection of basic information","Study Population 2: Recruited healthy volunteers or volunteers at low risk for sleep disorders. Participants must meet all of the following criteria:"],"whoShouldSkip":["A participant meeting any of the following criteria will be excluded:","Unable to complete full-night PSG","Unable to wear or use the study devices, or has clear intolerance to the devices or adhesive materials","Requires continuous positive airway pressure (CPAP), noninvasive ventilation, supplemental oxygen, or another medical device during the night that may significantly interfere with signal acquisition from PSG or the study devices","Has persistent atrial fibrillation, a severe or unstable medical condition, significant organ dysfunction, or any condition that substantially affects sleep","Has severe cognitive impairment, psychiatric or behavioral abnormalities, or another condition that prevents understanding of the study or cooperation with study procedures","Is considered by the investigator to be unsuitable for completion of overnight monitoring"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,000 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.944Z"},{"nctId":"NCT07908563","title":"Dupilumab in Major Depressive Disorder","officialTitle":"Target Validation of Interleukin-4 Receptor Alpha for Major Depressive Disorder","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Icahn School of Medicine at Mount Sinai","sponsorClass":"OTHER","summary":"This study aims primarily to test target engagement of dupilumab by assessing changes in peripheral immune markers following interleukin-4 receptor alpha (IL-4Rα) blockade in adults with major depressive disorder (MDD). Secondary aims include evaluating safety, tolerability, feasibility, and open-label effects on depressive symptoms, blood-based immune markers, blood-brain barrier (BBB) function, and functional brain reward circuitry.","conditions":["Major Depressive Disorder"],"keywords":["interleukin-4","dupixent","monoclonal antibody","inflammation","dupilumab","IL-4"],"interventions":[{"type":"DRUG","name":"Dupilumab Injection"}],"enrollment":34,"startDate":"2026-08-27","completionDate":"2028-12","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria for MDD participants:\n\n1. Written informed consent (and assent when applicable) obtained from subject;\n2. Ability for the subject to comply with the requirements of the study as determined by the PI;\n3. Men and women, age 18-65 years;\n4. Participants must meet DSM-5 criteria for Major Depressive Disorder \\[MDD\\]) in a current major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV);\n5. If patient is taking antidepressant medication, they must be on a stable dose for at least 4 weeks prior to baseline (6 weeks for fluoxetine);\n6. Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score ≥ 14;\n7. If female of childbearing potential, must agree to use of a medically accepted form of contraception (including barrier contraception such as condoms, oral contraceptive pills, or intrauterine devices) starting at least one cycle prior to study drug initiation, or else agree to abstinence until 6 months after the last dose of study drug.\n8. Male patients, if heterosexually active with a partner who is female of childbearing potential, pregnant, or breastfeeding, must agree to barrier contraception for the treatment period and for at least 6 months after the last dose of study drug. Female partners of male participants must use at least one form of medically accepted contraception starting at least one cycle prior to male patient study drug initiation until 6 months after the last dose of study drug.\n\nExclusion Criteria for MDD Participants:\n\n1. A primary psychiatric diagnosis other than MDD as defined by DSM-5; \\[comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and posttraumatic stress disorder (PTSD) are allowed\\];\n2. Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder;\n3. Diagnosis of a major neurocognitive disorder;\n4. Meets criteria for a moderate or severe substance use disorder within the past 6 months, with the exception of nicotine use disorder;\n5. Any contraindication to MRI including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, or inability to lie still for 1 hour or more;\n6. Positive urine toxicology screen for illicit drugs (other than cannabis) at the time of screening;\n7. Serious and imminent risk of self-harm or violence as determined by the PI;\n8. History of suicide attempt in the past 2 years or screening CSSRS Ideation Score \\>2 in the past month;\n9. Clinically significant abnormalities of laboratory tests or physical examination;\n10. Unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease); endocrinologic, neurologic (including history of severe head injury), immunologic/inflammatory, hematologic disease, or other medical conditions or abnormality (including relevant laboratory abnormalities at screening) that, in the opinion of the investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in the study, may make patient's participation unreliable, may interfere with study assessments, or may compromise the safety of the patient or the quality of the data;\n11. Concomitant treatments with other biologics or other immune-suppressant agents; PRN use of NSAIDs is permissible;\n12. Female participants who are pregnant, breastfeeding, or may become pregnant, or unwilling to practice birth control during participation in the study or the 6 months following. Male participants or the female partners who are unwilling to adhere to the birth control requirements specified in Section 5.1 (points 8 and 9);\n13. Presence of a known hypersensitivity to dupilumab or any excipients in dupilumab, or planned upcoming receipt of a live vaccination, or receipt of a live attenuated vaccination within 30 days prior to the receipt of the first dupilumab injection;\n14. Presence of an active tuberculosis infection, untreated latent TB, or a positive result on TB test (Quantiferon Gold) at screening, as well as known history of human immunodeficiency virus (HIV) infection, Hepatitis B, and/or Hepatitis C.\n15. History of malignancy within 5 years of baseline assessment (excluding non-melanoma skin cancers).\n\nInclusion Criteria for healthy control participants:\n\n1. Written informed consent obtained from subject;\n2. Ability for the subject to comply with the requirements of the study as determined by the PI;\n3. Ages 18-65, any gender;\n4. No current or past DSM-5 psychiatric disorder as determined by SCID-5-RV or MINI;\n5. Meet all MRI safety criteria.\n\nExclusion Criteria for healthy control participants:\n\n1. Any unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (including history of severe head injury), immunologic, or hematologic disease;\n2. Concomitant treatments with other biologics or other immune-suppressant agents (PRN use of NSAIDs is permissible);\n3. Female participants who are pregnant at the time of baseline assessments (e.g., MRI);\n4. Positive urine toxicology screen for illicit drugs at the time of screening.","locations":[{"facility":"The Dennis S. Charney, MD, Depression and Anxiety Discovery Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mackenzie B Hargrove, MPH","phone":"332-243-7052","email":"mackenzie.brown@mssm.edu"},{"name":"Alexia Lizzano, BS","phone":"332-243-7059","email":"alexia.lizzano@mssm.edu"}],"primaryOutcomes":["Interleukin-4 receptor alpha (IL-4α)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":["dupilumab"],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 2: testing Dupilumab Injection for Major Depressive Disorder","inPlainEnglish":"This study aims primarily to test target engagement of dupilumab by assessing changes in peripheral immune markers following interleukin-4 receptor alpha (IL-4Rα) blockade in adults with major depressive disorder (major depression). Secondary aims include evaluating safety, tolerability, feasibility, and open-label effects on depressive symptoms, blood-based immune markers, blood-brain barrier (BBB) function, and functional brain reward circuitry.","whoItsFor":["Ages 18 Years to 65 Years","for major depression participants:","Ability for the subject to comply with the requirements of the study as determined by the PI;","Men and women, age 18-65 years;","Participants must meet DSM-5 criteria for Major Depressive Disorder \\[major depression\\]) in a current major depressive episode (MDE) as determined by a study psychiatrist and confirmed using the Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV);","If patient is taking antidepressant medication, they must be on a stable dose for at least 4 weeks prior to baseline (6 weeks for fluoxetine);","Quick Inventory of Depressive Symptoms - Clinician Administered (QIDS-C) score ≥ 14;"],"whoShouldSkip":["for major depression Participants:","A primary psychiatric diagnosis other than major depression as defined by DSM-5; \\[comorbid anxiety disorders (including agoraphobia, generalized anxiety disorder, social anxiety disorder and panic disorder) and posttraumatic stress disorder (PTSD) are allowed\\];","Has a history of schizophrenia or other psychotic disorder, major depressive disorder with psychotic features, or bipolar I or II disorder;","Diagnosis of a major neurocognitive disorder;","Meets criteria for a moderate or severe substance use disorder within the past 6 months, with the exception of nicotine use disorder;","Any contraindication to MRI including claustrophobia, any trauma or surgery which may have left magnetic material in the body, magnetic implants or pacemakers, or inability to lie still for 1 hour or more;","Positive urine toxicology screen for illicit drugs (other than cannabis) at the time of screening;"],"whatHappens":"If you join, the listed intervention(s) are Dupilumab Injection. The registry lists allocation as randomized. This study aims primarily to test target engagement of dupilumab by assessing changes in peripheral immune markers following interleukin-4 receptor alpha (IL-4Rα) blockade in adults with major depressive disorder (major depression).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 34 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.702Z"},{"nctId":"NCT07908680","title":"A Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia","officialTitle":"A Randomized, Participant and Investigator-blinded, Placebo-controlled, Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of XEP527 in Patients With Stable Schizophrenia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Novartis Pharmaceuticals","sponsorClass":"INDUSTRY","summary":"This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.","conditions":["Schizophrenia"],"keywords":["XEP527","stable schizophrenia"],"interventions":[{"type":"DRUG","name":"XEP527"},{"type":"DRUG","name":"Placebo"}],"enrollment":36,"startDate":"2026-11-04","completionDate":"2028-03-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study\n* Participants 18 to 65 years of age, inclusive at screening\n* Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization\n* Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI), version 7.0.2. at screening\n* Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9\n* Participant is treated with a single antipsychotic (typical and/or atypical) with a stable dose for at least 12 weeks prior to randomization. Participant must agree to maintain the treatment with standard of care antipsychotic for the duration of the study\n* Participants who are treated with psychotropic medications other than antipsychotics need to be taking these medications as a stable dose for at least 12 weeks before randomization\n\nKey Exclusion Criteria:\n\n* Participant experienced worsening of schizophrenia within 3 months prior to randomization documented by symptom exacerbation and/or hospitalizations (hospitalization for social management and/or day hospital programs within this time are acceptable)\n* Participant was treated with Clozapine, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last 6 months prior to randomization\n* Participant meets the DSM-5 criteria for another psychotic disorder\n* Participant has a history of substance or alcohol use disorder, except nicotine or caffeine, within 1 year before screening, or current abuse as determined by urine drug screen or alcohol test\n* Score \"yes\" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if this ideation occurred in the past 6 months, or \"yes\" on any item of the Suicidal Behavior section, except for the \"Non-Suicidal Self-Injurious Behavior\" (item also included in the Suicidal Behavior section), if this behavior occurred in the past 2 years.\n\nOther protocol-defined inclusion/exclusion criteria may apply.","locations":[{"facility":"Pillar Clinical Research LLC","city":"Bentonville","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Novartis Pharmaceuticals","phone":"1-888-669-6682","email":"novartis.email@novartis.com"},{"name":"Novartis Pharmaceuticals","phone":"+41613241111","email":""}],"primaryOutcomes":["Incidence of adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["bentonville-arkansas"],"enrichment":{"headline":"Phase 1: testing XEP527 for Schizophrenia","inPlainEnglish":"This study is designed to assess the whether it is safe and how hard side effects are to live with of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.","whoItsFor":["Ages 18 Years to 65 Years","Participants 18 to 65 years of age, inclusive at screening","Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization","Participant meets the following requirements per PANSS at screening and baseline: Total PANSS score ≤ 110, Score ≤ 4 (moderate) for item P1-P7, Score ≤ 4 (moderate) for G9","Participant is treated with a single antipsychotic (typical and/or atypical) with a stable dose for at least 12 weeks prior to randomization. Participant must agree to maintain the treatment with standard of care antipsychotic for the duration of the study","Participants who are treated with psychotropic medications other than antipsychotics need to be taking these medications as a stable dose for at least 12 weeks before randomization"],"whoShouldSkip":["Participant experienced worsening of schizophrenia within 3 months prior to randomization documented by symptom exacerbation and/or hospitalizations (hospitalization for social management and/or day hospital programs within this time are acceptable)","Participant was treated with Clozapine, electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in the last 6 months prior to randomization","Participant meets the DSM-5 criteria for another psychotic disorder","Participant has a history of substance or alcohol use disorder, except nicotine or caffeine, within 1 year before screening, or current abuse as determined by urine drug screen or alcohol test","Other protocol-defined inclusion/"],"whatHappens":"If you join, the listed intervention(s) are XEP527, or Placebo. The registry lists allocation as randomized. This study is designed to assess the whether it is safe and how hard side effects are to live with of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 36 people at Bentonville. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.038Z"},{"nctId":"NCT07909265","title":"Prospective Study of Cadonilimab With Lenvatinib in Renal Cell Carcinoma","officialTitle":"A Prospective, Open, Multi-cohort Study of Cadonilimab Combined With Lenvatinib in Renal Cell Carcinoma","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"FACTORIAL","masking":"NONE","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","sponsorClass":"OTHER","summary":"This is a prospective, open, multi-cohort phase II study The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up).\n\nScreening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility.\n\nDuration of treatment: Patients were treated with Cadonilimab in combination with lenvatinib until disease progression or intolerable toxicity developed. Every 3 weeks was a dosing cycle, and every 6 weeks was a treatment assessment.\n\nFollow-up period: The safety follow-up period began after the last study treatment, and was followed up once on the 30th day (±7 days). Subjects should go to the research center for the examination of vital signs, physical examination, laboratory examination and other protocol requirements, and evaluate AE, concomitant medication and concomitant treatment.\n\nAfter the end of the safety follow-up period, the subjects entered the 1-year survival follow-up period, which was conducted every 3 months. They could be visited by telephone follow-up and other effective ways to collect survival information and follow-up treatment information. Survival follow-up lasted until death, loss of follow-up, withdrawal","conditions":["Renal Cell Carcinoma (Kidney Cancer)","Clear Cell Renal Cell Carcinoma"],"keywords":["Renal cell carcinoma","Cadonilimab","Lenvatinib","PD-1/CTLA-4 Bispecific Antibody"],"interventions":[{"type":"DRUG","name":"Cadonilimab,Lenvatinib"}],"enrollment":54,"startDate":"2025-04-01","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Sign written informed consent before enrollment;\n2. Age ≥18 years old;\n3. Histological and/or cytological diagnosis of unresectable advanced renal cell carcinoma;\n4. Cohort 1: renal clear cell carcinoma, mainly renal clear cell carcinoma, was included. Patients progressed after previous treatment with immune checkpoint inhibitor (ICI), and the number of previous treatment lines was less than 3;\n5. Cohort 2: Non-transparent renal cell carcinoma was included. Subjects who had not received systematic treatment before or whose disease progressed after TKI or ICI treatment before could be included, with the number of previous treatment lines ≤3; They mainly included cohort A: papillary cell carcinoma, cohort B: chromophobe cell carcinoma, cohort C: collecting tubuloid carcinoma, cohort D: other types.\n6. Consent to medical treatment;\n7. Understand and voluntarily sign written informed consent.\n8. ECOG score: 0 \\~ 1;\n9. At least one measurable lesion (according to RECIST criteria, the length of CT scan for non-lymph node lesions ≥10 mm, and the short diameter of CT scan for lymph node lesions ≥15 mm);\n10. Have adequate organ function:\n11. Blood routine: Absolute Neutrophil Count (ANC) 1.5×10\\^9/L, Platelet (PLT) ≥70×10\\^9/L, Hemoglobin (HGB) ≥80g/L;\n12. Liver function: Serum Total Bilirubin (TBIL) ≤1.5× Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Transferase (AST) ≤3×ULN; Serum albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; After routine liver protection treatment, the patients could meet the above criteria and be stable for at least 1 week.\n13. Kidney function: serum Creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥50 mL/mi (using the standard Cockcroft-Gault formula) :\n14. Coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR are within the prescribed range of anticoagulants.\n15. Estimated survival ≥3 months;\n16. Use of a medically approved contraceptive method is required during the study treatment period and for at least 120 days after the end of the study, and sperm donation to another person or cryopreservation for fertilization and reproduction is not permitted during this period.\n\nAbility to adhere to research visit schedules and other protocol requirements.\n\nExclusion Criteria:\n\n1. Poor patient compliance;\n2. Subjects with any severe and/or uncontrolled disease. Includes:\n\n   Poor blood pressure control (systolic ≥150mmHg or diastolic ≥100mmHg); Poor diabetes control (fasting blood glucose \\[FBG\\] \\> 10mmol/L);\n3. Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and grade ≥2 congestive heart failure (New York Heart Association \\[NYHA\\] grade);\n4. Active or uncontrolled severe infections (≥CTCAE grade 2 infections) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis.\n5. Active hepatitis (transaminase does not meet the inclusion criteria, hepatitis B reference: HBV DNA≥2000 IU/ml or ≥104 copy number /ml; Hepatitis C reference: HCV RNA≥2000 IU/ml or ≥104 copy number /ml; After nucleotide antiviral therapy, those who are lower than the above criteria can be included in the group); Chronic hepatitis B virus carriers, HBV DNA \\< 104 IU/ml, must also receive antiviral therapy during the trial to be enrolled;\n6. Renal failure requires hemodialysis or peritoneal dialysis;\n7. A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n8. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the initiation of study treatment, except for alternative therapies (e.g., thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency); Are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. Dose \\> 10mg/ day of prednisone or other equivalent hormone and within 2 weeks of initial administration and continued use;\n9. People with a history of active tuberculosis;\n10. Failure to control, still need repeated drainage, ascites, pericardial effusion, pleural effusion;\n11. Patients who have undergone major organ transplants;\n12. Study participants who received major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the start of treatment; Or have a wound or fracture that has not healed for a long time;\n13. Patients with severe hypersensitivity after the use of monoclonal antibodies; Known allergy to the active ingredients or excipients of the drug in this study;\n14. Participating in or having participated in other clinical investigators within 4 weeks prior to the start of the study;\n15. People with a history of severe allergies;\n16. At risk of bleeding, or coagulation dysfunction, or being treated with thrombolysis;\n17. Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;\n18. Subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with concomitant diseases that, in the judgment of the investigator, seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons that are not suitable for enrollment. Have a clear history of neurological and psychiatric disorders, such as dementia, epilepsy, or predisposition to epilepsy;\n19. If, in the investigator's judgment, there is a concomitant medical condition (such as serious diabetes, thyroid disease, and mental illness) that seriously endangers the subject's safety or prevents the subject from completing the study, or there is a serious and/or unstable medical, mental or other condition (including abnormal laboratory tests) that affects the patient's safety or prevents the patient from providing informed consent, Or the presence of any psychological, familial, sociological or geographical conditions that affect the study protocol and follow-up plan;\n20. The investigator considers it inappropriate to participate in the clinical trial for any reason;","locations":[{"facility":"National Cancer Center / Cancer Hospital, Chinese Academy of Medical Sciences","city":"Beijing","state":"Panjiayuan Nanli","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiongjun Ye, Ph.D","phone":"13910380916","email":"yexiongjun@cicams.ac.cn"}],"primaryOutcomes":["Objective Response Rate(ORR)"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing Cadonilimab,Lenvatinib for Renal Cell Carcinoma (Kidney Cancer)","inPlainEnglish":"This is a prospective, open, multi-cohort phase II study The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up). Screening period: Participants are required to undergo a screening period within 28 days prior to the study's first treatment to determine eligibility.","whoItsFor":["Ages 18 Years to any","Histological and/or cytological diagnosis of unresectable advanced renal cell carcinoma;","Cohort 1: renal clear cell carcinoma, mainly renal clear cell carcinoma, was included. Patients progressed after previous treatment with immune checkpoint inhibitor (ICI), and the number of previous treatment lines was less than 3;","Consent to medical treatment;","ECOG score: 0 \\~ 1;","At least one measurable lesion (according to RECIST criteria, the length of CT scan for non-lymph node lesions ≥10 mm, and the short diameter of CT scan for lymph node lesions ≥15 mm);","Have adequate organ function:","Blood routine: Absolute Neutrophil Count (ANC) 1.5×10\\^9/L, Platelet (PLT) ≥70×10\\^9/L, Hemoglobin (HGB) ≥80g/L;"],"whoShouldSkip":["Poor patient compliance;","Subjects with any severe and/or uncontrolled disease. Includes:","Poor blood pressure control (systolic ≥150mmHg or diastolic ≥100mmHg); Poor diabetes control (fasting blood glucose \\[FBG\\] \\> 10mmol/L);","Have grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc≥470ms), and grade ≥2 congestive heart failure (New York Heart Association \\[NYHA\\] grade);","Active or uncontrolled severe infections (≥CTCAE grade 2 infections) requiring systemic antibacterial, antifungal, or antiviral treatment, including tuberculosis","Renal failure requires hemodialysis or peritoneal dialysis;","A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;"],"whatHappens":"If you join, the listed intervention(s) are Cadonilimab,Lenvatinib. The registry lists allocation as randomized. This is a prospective, open, multi-cohort phase II study The study included a screening period (participants signed informed consent no more than 28 days before the first treatment in the study), a treatment period (treatment termination was defined as termination of treatment for any reason, such as imaging confirmation of disease progression, failure to tolerate adverse effects after dose adjustment, or early withdrawal for any reason), and a follow-up period (including end-of-treatment visits, safety visits, and survival follow-up).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.935Z"},{"nctId":"NCT07909382","title":"Multi-biomarkers in DEE","officialTitle":"Identification and Integration of Multi-omic Biomarkers for the Characterization of Patients With Developmental and Epileptic Encephalopathies (DEE) With a View to Clinical Trials / Identificazione e Integrazione di Multi-omici Biomarcatori Per la Caratterizzazione Dei Pazienti Con Encefalopatie Epilettiche e Dello Sviluppo (DEE) in Vista Dei Trials Clinici","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istituto Giannina Gaslini","sponsorClass":"OTHER","summary":"Developmental and Epileptic Encephalopathies (DEEs) with a genetic cause represent a complex group of neurodevelopmental disorders characterized by intellectual disability and drug-resistant epilepsy. Because targeted, disease-modifying precision therapies like gene replacement and antisense oligonucleotides are rapidly approaching clinical trials, establishing objective diagnostic, prognostic, and therapeutic biomarkers is an urgent priority. Promoted by the IRCCS Istituto Giannina Gaslini and coordinated by Prof. Pasquale Striano, the MOBi-DEE protocol aims to identify and integrate multi-omic biomarkers using routine clinical investigations.\n\nThe study is designed as a multicenter, international, observational, cross-sectional, case-control, non-interventistico, and non-profit project targeting an enrollment of approximately 200 participants up to 55 years of age, including patients with genetically confirmed DEE and control subjects.\n\nThe methodology relies on biological samples and instrumental tests already collected during standard clinical follow-ups, avoiding any additional invasive procedures purely for research. Blood, urine, and stool samples are collected for metabolomic profiling, extracellular vesicle analysis, and gut microbiota metagenomics. Cerebrospinal fluid is analyzed exclusively if obtained as excess residual material from necessary diagnostic or therapeutic lumbar punctures or ventricular drains. Additionally, resting-state electroencephalogram recordings are evaluated via quantitative analysis to profile brain electrical dynamics, while electronic clinical report forms capture demographic data, genetic diagnoses, seizure characteristics, neurological status, and gastrointestinal symptoms via standardized questionnaires like Rome IV.\n\nThis research is vital for patients, families, and healthcare providers because it helps overcome the barrier of rare, heterogeneous patient populations through biomarker discovery, ultimately aiding the design of robust clinical trials for breakthrough therapies. By depending primarily on routine clinical samples and non-invasive collection methods, the study minimizes any added physical burden or risk for patients and families. Furthermore, strict data protection protocols govern privacy, while multi-centre material transfer agreements and future peer-reviewed publications aim to accelerate international research and therapeutic development.","conditions":["Developmental and Epileptic Encephalopathies (DEE)"],"keywords":["multi-omic biomarkers"],"interventions":[],"enrollment":200,"startDate":"2024-07-04","completionDate":"2025-12-01","sex":"ALL","minAge":"0 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* For patients:\n\nDiagnosis of Developmental and Epileptic Encephalopathy with proven genetic etiology report;\n\nInformed consent from a parent/legal representative in case of inability to provide consent due to severe cognitive disability, and where required by age, informed assent.\n\nFor controls:\n\nPresence of informed consent from the participant and/or their legal guardian, and where required by age, informed assent.\n\nExclusion Criteria:\n\n* For patients:\n\nLack of informed consent / assent.\n\nDiagnosis other than Developmental and Epileptic Encephalopathy with genetic etiology;\n\nAbsence of genetic test report;\n\nSevere conditions requiring pharmacological polytherapy, in addition to antiseizure medications (e.g., kidney disease, heart disease, diabetes, oncological disease, etc.);\n\nConcomitant use, or use up to 1 month prior to sampling, of antibiotic medications.\n\nFor controls:\n\nLack of informed consent / assent.\n\nSevere conditions requiring pharmacological polytherapy (e.g., kidney disease, heart disease, diabetes, oncological disease, etc.);\n\nConcomitant use, or use up to 3 months prior to sampling, of medications acting on the central nervous system;\n\nConcomitant use, or use up to 1 month prior to sampling, of antibiotic medications.","locations":[{"facility":"Division of Neurology, University Hospital Antwerp","city":"Antwerp","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Danish Epilepsy Centre","city":"Dianalund","state":"","country":"Denmark","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pediatric neurology unit, Assistance publique hôpitaux de Marseille and Aix-Marseille University, Timone University Hospital","city":"Marseille","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null},{"facility":"Division of Pediatric Epileptology, Center for Pediatrics and Adolescent Medicine University Hospital Heidelberg","city":"Heidelberg","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Pediatric Neurology Department, Edmond and Lily Safra Children's Hospital","city":"Ramat Aviv","state":"","country":"Israel","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto delle Scienze Neurologiche di Bologna","city":"Bologna","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Università di Catanzaro","city":"Catanzaro","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Meyer","city":"Florence","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Istituto Giannina Gaslini","city":"Genova","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale dei Bambini \"Vittore Buzzi\"","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Ospedale Pediatrico Bambino Gesù","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Policlinico Universitario Agostino Gemelli","city":"Roma","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Child and Adolescent Psychiatry, Amsterdam UMC","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"Department of Neurology, Hospital Sant Joan de Deu","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pasquale Striano, MD, PHD","phone":"+3901056362758","email":"pasqualestriano@gaslini.org"}],"primaryOutcomes":["Neurophysiological profiling of DEE patients.","Metabolomic profiling of DEE patients compared to controls across different biofluids (plasma, urine, stool, cerebrospinal fluid)","Gut microbiota profiling of DEE patients compared to controls","Profiling of extracellular vesicles identified in the analyzed biofluids of participants"],"hasResults":false,"conditionSlugs":["als","epilepsy"],"drugSlugs":[],"locationSlugs":["antwerp-belgium","dianalund-denmark","marseille-france","heidelberg-germany","ramat-aviv-israel","bologna-italy","catanzaro-italy","florence-italy","genova-italy","milan-italy","roma-italy","amsterdam-netherlands","barcelona-spain"],"enrichment":{"headline":"Multi-biomarkers in DEE","inPlainEnglish":"Developmental and Epileptic Encephalopathies (DEEs) with a genetic cause represent a complex group of neurodevelopmental disorders characterized by intellectual disability and drug-resistant epilepsy. Because targeted, disease-modifying precision therapies like gene replacement and antisense oligonucleotides are rapidly approaching clinical trials, establishing objective diagnostic, prognostic, and therapeutic biomarkers is an urgent priority.","whoItsFor":["Ages 0 Years to 55 Years","Diagnosis of Developmental and Epileptic Encephalopathy with proven genetic etiology report;"],"whoShouldSkip":["Diagnosis other than Developmental and Epileptic Encephalopathy with genetic etiology;","Absence of genetic test report;","Severe conditions requiring pharmacological polytherapy, in addition to antiseizure medications (e.g., kidney disease, heart disease, diabetes, oncological disease, etc.);","Concomitant use, or use up to 1 month prior to sampling, of antibiotic medications","Severe conditions requiring pharmacological polytherapy (e.g., kidney disease, heart disease, diabetes, oncological disease, etc.);","Concomitant use, or use up to 3 months prior to sampling, of medications acting on the central nervous system;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 14 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.907Z"},{"nctId":"NCT07909486","title":"Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy","officialTitle":"Identification of Biomarkers for Vagus Nerve Stimulation in Patients With Refractory Epilepsy","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Cliniques universitaires Saint-Luc- Université Catholique de Louvain","sponsorClass":"OTHER","summary":"A VNS longitudinal study focused on pre and post-VNS implantation in order to predict the VNS response and to understand better mechanisms of VNS using some connectivity and network measures.","conditions":["Refractory Epilepsy"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Vagus nerve stimulation"}],"enrollment":20,"startDate":"2022-02-28","completionDate":"2025-09-01","sex":"ALL","minAge":"18 Years","maxAge":"79 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged \\>18 years\n* Intelectual Quotient \\>55 on Wechsler scale (normal or mild cognitive impairment)\n* Patients have refractory epilepsy and are planned for VNS implantation\n\nExclusion Criteria:\n\n* Concomitant laryngeal pathology (e.g. recurrent nerve lesions, vocal fold paralysis).\n* Dementia/ Neurodegenerative diseases","locations":[{"facility":"Clinique Universitaires Saint-Luc","city":"Brussels","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Riëm EL TAHRY, Pr.","phone":"+322 764 28 55","email":"riem.eltahry@uclouvain.be"}],"primaryOutcomes":["Pupillometry","P300","LMEP"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["brussels-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Vagus nerve stimulation for Refractory Epilepsy","inPlainEnglish":"A VNS longitudinal study focused on pre and post-VNS implantation in order to predict the VNS response and to understand better mechanisms of VNS using some connectivity and network measures.","whoItsFor":["Ages 18 Years to 79 Years","Patients aged \\>18 years","Intelectual Quotient \\>55 on Wechsler scale (normal or mild cognitive impairment)","Patients have refractory epilepsy and are planned for VNS implantation"],"whoShouldSkip":["Concomitant laryngeal pathology (e.g. recurrent nerve lesions, vocal fold paralysis)","Dementia/ Neurodegenerative diseases"],"whatHappens":"If you join, the listed intervention(s) are Vagus nerve stimulation. The registry lists allocation as na. A VNS longitudinal study focused on pre and post-VNS implantation in order to predict the VNS response and to understand better mechanisms of VNS using some connectivity and network measures.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Brussels. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.902Z"},{"nctId":"NCT07909967","title":"Observational Analytical Validation Study of the Replior ScratchSense","officialTitle":"Observational Analytical Validation Study of the Replior ScratchSense for Nocturnal Scratching Assessment","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Replior AB","sponsorClass":"INDUSTRY","summary":"Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life. Existing approaches to characterizing Nocturnal Scratching-such as self-reports, sleep diaries, and video monitoring-are often subjective, labor-intensive, or lack scalability for widespread use.\n\nEmerging wearable technologies offer an alternative, by enabling objective, continuous, and non- invasive signal related to scratch behavior during sleep.","conditions":["Atopic Dermatitis","Pruritus","Chronic Pruritus of Unknown Origin"],"keywords":["Scratch","Sleep","Sensor","Wireless","Nocturnal Scratch","Sleep disorders","Sleep Time Opportunity"],"interventions":[{"type":"DEVICE","name":"Scratch and sleep research tracking"}],"enrollment":35,"startDate":"2026-10-12","completionDate":"2026-12-10","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male / female participant, aged 18 to 65 years inclusive. Negative pregnancy test at screening for childbearing potential women. Presence of itch-related and/or scratching-inducing conditions: documented or self-reported history of nocturnal itching and scratching, due to conditions such as:\n\n  * Atopic dermatitis\n  * Chronic pruritus of unknown origin\n  * Other pruritic dermatological or systemic conditions. Expected Nocturnal Scratch activity: participants must: Have experienced Nocturnal Scratching in the past 7 days, and\n  * Be considered likely to scratch during the study period, based on medical history, clinician judgment, or recent self-report\n\nExclusion Criteria:\n\n* No current or expected nocturnal itch: well-controlled conditions or no recent reports of nighttime scratching.\n* Confounding movement disorders or sleep conditions: diagnosed restless legs syndrome, periodic limb movement disorder, moderate/severe obstructive sleep apnea, Parkinson's disease, or other conditions that may interfere with motion analysis.\n* Recent changes in anti-pruritic treatment: Initiation or dose changes of systemic medications that may suppress nocturnal itch within the past 2 weeks, including: i. Oral corticosteroids ii. Immunosuppressive agents (e.g., cyclosporine, methotrexate) iii. Biologics (e.g., dupilumab) unless on a stable dose ≥8 weeks iv. Sedating antihistamines unless stable for ≥1 week.\n* Topical treatment use: initiation of topical corticosteroids, calcineurin inhibitors, or emollients within 3 days prior to study start, and no use during the study.\n* Severe psychiatric or cognitive impairment that could impair the ability to consent or comply with the protocol","locations":[{"facility":"Eurofins Optimed 1 rue des Essarts, 38610 Gières - France","city":"Grenoble","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Christer Nilsson Study Director","phone":"+46 706956689","email":"christer.nilsson@replior.se"}],"primaryOutcomes":["Number of Scratch bout"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["grenoble-france"],"enrichment":{"headline":"Not a traditional drug phase: Scratch and sleep research tracking for Atopic Dermatitis","inPlainEnglish":"Nocturnal scratching is a frequent and meaningful symptom in dermatological conditions such as atopic dermatitis. It may reflect underlying disease activity and can substantially disrupt overall sleep and quality of life.","whoItsFor":["Ages 18 Years to 65 Years","Chronic pruritus of unknown origin","Other pruritic dermatological or systemic conditions. Expected Nocturnal Scratch activity: participants must: Have experienced Nocturnal Scratching in the past 7 days, and","Be considered likely to scratch during the study period, based on medical history, clinician judgment, or recent self-report"],"whoShouldSkip":["No current or expected nocturnal itch: well-controlled conditions or no recent reports of nighttime scratching","Confounding movement disorders or sleep conditions: diagnosed restless legs syndrome, periodic limb movement disorder, moderate/severe obstructive sleep apnea, Parkinson's disease, or other conditions that may interfere with motion analysis","Topical treatment use: initiation of topical corticosteroids, calcineurin inhibitors, or emollients within 3 days prior to study start, and no use during the study","Severe psychiatric or cognitive impairment that could impair the ability to consent or comply with the protocol"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 35 people at Grenoble. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.824Z"},{"nctId":"NCT07910006","title":"Multimodal Assessment of NMES Effects on Respiratory and Peripheral Muscles in COPD","officialTitle":"COMPARATIVE EFFECTS OF TARGETED NEUROMUSCULAR ELECTRICAL STIMULATION (NMES) ON RESPIRATORY AND PERIPHERAL MUSCLES IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): A MULTIMODAL ASSESSEMENT USING DIAPHRAGM ULTRASOUND AND PLASMA BIOMARKERS (IL-6 AND IGF-1)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Universitas Padjadjaran","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are:\n\n* Does targeted NMES improve diaphragm thickening fraction and excursion as measured by diaphragm ultrasound?\n* What are the comparative effects of targeted NMES on plasma biomarkers, specifically Interleukin-6 (IL-6) and Insulin-like Growth Factor-1 (IGF-1)? Researchers will compare three groups: the first intervention group receiving intercostal NMES combined with Pursed-Lip Breathing (PLB), the second intervention group receiving quadriceps NMES combined with PLB, and a control group receiving sham upper trapezius NMES combined with PLB, to see if targeted NMES provides superior improvements in respiratory and peripheral muscle function.\n\nParticipants will:\n\n* Undergo baseline screening, including a diaphragm ultrasound and a blood draw for plasma biomarkers (IL-6 and IGF-1)\n* Be randomly assigned to one of the three groups to receive either intercostal NMES, quadriceps NMES, or sham upper trapezius NMES, all combined with Pursed-Lip Breathing exercises\n* Complete a post-intervention assessment involving repeat ultrasound imaging and biomarker analysis to evaluate muscle and systemic changes","conditions":["Chronic Obstructive Pulmonary Disease (COPD)","Respiratory Muscle Dysfunction","Muscle Weakness"],"keywords":["Chronic Obstructive Pulmonary Disease","COPD","Neuromuscular Electrical Stimulation","NMES","Diaphragm Ultrasound","Diaphragm Excursion","Thickening Fraction"],"interventions":[{"type":"DEVICE","name":"Neuromuscular Electric Stimulation"},{"type":"OTHER","name":"Exercise"}],"enrollment":45,"startDate":"2026-10","completionDate":"2027-10","sex":"ALL","minAge":"40 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients diagnosed with stable Chronic Obstructive Pulmonary Disease (COPD), GOLD spirometric grade 2-4 (post-bronchodilator FEV1/FVC \\<0.70 with FEV1 \\<80% predicted), confirmed by a pulmonologist.\n* Age between 40 and 85 years old.\n* Willing to participate in the study and sign the written informed consent form.\n\nExclusion Criteria:\n\n* Recent thoracic or abdominal surgery, pneumothorax, or a history of spontaneous pneumothorax.\n* Participation in other structured respiratory muscle training or pulmonary rehabilitation programs that may confound the study results.\n* Presence of neuromuscular, bulbar, laryngeal, or other disorders that may independently impair respiratory muscle function.\n* Use of a cardiac pacemaker or any metal/electronic implant at the intended stimulation area.\n* Diagnosis of heart failure classified as NYHA (New York Heart Association) class III-IV.\n* Presence of skin lesions, open wounds, or active dermatitis in the intended electrode placement areas.\n* Current use of systemic (oral) corticosteroids or history of use within 4 weeks prior to enrollment.","locations":[{"facility":"Faculty of Medicine Universitas Padjadjaran","city":"Bandung","state":"West Java","country":"Indonesia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Dian Marta Sari, Physiatrist","phone":"+62 812 2181 227","email":"dian.marta@unpad.ac.id"}],"primaryOutcomes":["Diaphragm Excursion (DE)","Diaphragm Thickening Fraction (TF)"],"hasResults":false,"conditionSlugs":["copd"],"drugSlugs":[],"locationSlugs":["bandung-indonesia"],"enrichment":{"headline":"Not a traditional drug phase: Neuromuscular Electric Stimulation for Chronic Obstructive Pulmonary Disease (COPD)","inPlainEnglish":"The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD). The main questions it aims to answer are: * Does targeted NMES improve diaphragm thickening fraction and excursion as measured by diaphragm ultrasound?","whoItsFor":["Ages 40 Years to 85 Years","Patients diagnosed with stable Chronic Obstructive Pulmonary Disease (COPD), GOLD spirometric grade 2-4 (post-bronchodilator FEV1/FVC \\<0.70 with FEV1 \\<80% predicted), confirmed by a pulmonologist","Age between 40 and 85 years old"],"whoShouldSkip":["Recent thoracic or abdominal surgery, pneumothorax, or a history of spontaneous pneumothorax","Participation in other structured respiratory muscle training or pulmonary rehabilitation programs that may confound the study results","Presence of neuromuscular, bulbar, laryngeal, or other disorders that may independently impair respiratory muscle function","Use of a cardiac pacemaker or any metal/electronic implant at the intended stimulation area","Diagnosis of heart failure classified as NYHA (New York Heart Association) class III-IV","Presence of skin lesions, open wounds, or active dermatitis in the intended electrode placement areas","Current use of systemic (oral) corticosteroids or history of use within 4 weeks prior to enrollment"],"whatHappens":"If you join, the listed intervention(s) are Neuromuscular Electric Stimulation, or Exercise. The registry lists allocation as randomized. The goal of this clinical trial is to learn if targeted neuromuscular electrical stimulation (NMES) can treat respiratory and peripheral muscle weakness in patients with chronic obstructive pulmonary disease (COPD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at Bandung. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.661Z"},{"nctId":"NCT07910097","title":"Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas","officialTitle":"Flurpiridaz F-18 PET/CT Imaging for Detecting Parathyroid Adenomas in Patients With Primary Hyperparathyroidism","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Pennsylvania","sponsorClass":"OTHER","summary":"Study of Flurpiridaz F-18 positron emission tomography/computed tomography (PET/CT) as a diagnostic imaging tool to detect abnormal parathyroid glands in patients with primary hyperparathyroidism, prior to multi-parathyroid gland surgical exploration. Patients with known or suspected parathyroid adenomas will be eligible for this study. Comparisons of diagnostic performance using Flurpiridaz F-18 PET/CT versus standard of care dual time point sestamibi single photon emission computed computed tomography/computed tomography (SPECT/CT) imaging will be tested.","conditions":["Hyperparathyroidism"],"keywords":["PET/CT","Flycardo"],"interventions":[{"type":"DRUG","name":"Flurpiridaz PET/CT"}],"enrollment":20,"startDate":"2026-08-15","completionDate":"2028-09-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Adult patients, at least 18 years of age\n2. History of primary hyperparathyroidism as clinically confirmed by serum laboratory values of elevated calcium levels (\\>10.2 mg/dl) and abnormal or inappropriately normal parathyroid hormone concentrations (normal range: 15 to 65 pg/ml).\n3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.\n4. Participants must have had prior SPECT/CT sestamibi parathyroid imaging within 6 months of this investigational study or planned SPECT/CT sestamibi parathyroid imaging scheduled prior to this investigational study.\n5. Planned surgery within 6 months following this investigational study.\n\nExclusion Criteria:\n\n1. Females who are pregnant or breast feeding at the time of the PET/CT scan will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential ( as self-reported by menstrual history) before the injection of radiotracer.\n2. Inability to tolerate imaging procedures, including but not limited to claustrophobia, inability to remain still during scanning, or any other condition that, in the judgment of the investigator or treating physician, would interfere with safe or adequate imaging.\n3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.","locations":[{"facility":"Unversity of Pennsylvania","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erin Schubert, BA","phone":"215-573-6569","email":"erin.schubert@pennmedicine.upenn.edu"},{"name":"Mary Hansbury, BS","phone":"215-746-8192","email":"mary.hansbury@pennmedicine.upenn.edu"}],"primaryOutcomes":["Sensitivity","sensitivity"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["philadelphia-pennsylvania"],"enrichment":{"headline":"Early phase 1: testing Flurpiridaz PET/CT for Hyperparathyroidism","inPlainEnglish":"Study of Flurpiridaz F-18 positron emission tomography/computed tomography (PET/CT) as a diagnostic imaging tool to detect abnormal parathyroid glands in patients with primary hyperparathyroidism, prior to multi-parathyroid gland surgical exploration. Patients with known or suspected parathyroid adenomas will be eligible for this study.","whoItsFor":["Ages 18 Years to any","Adult patients, at least 18 years of age","History of primary hyperparathyroidism as clinically confirmed by serum laboratory values of elevated calcium levels (\\>10.2 mg/dl) and abnormal or inappropriately normal parathyroid hormone concentrations (normal range: 15 to 65 pg/ml)","Participants must have had prior SPECT/CT sestamibi parathyroid imaging within 6 months of this investigational study or planned SPECT/CT sestamibi parathyroid imaging scheduled prior to this investigational study","Planned surgery within 6 months following this investigational study"],"whoShouldSkip":["Females who are pregnant or breast feeding at the time of the PET/CT scan will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential ( as self-reported by menstrual history) before the injection of radiotracer","Inability to tolerate imaging procedures, including but not limited to claustrophobia, inability to remain still during scanning, or any other condition that, in the judgment of the investigator or treating physician, would interfere with safe or adequate imaging","Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study"],"whatHappens":"If you join, the listed intervention(s) are Flurpiridaz PET/CT. The registry lists allocation as na. Study of Flurpiridaz F-18 positron emission tomography/computed tomography (PET/CT) as a diagnostic imaging tool to detect abnormal parathyroid glands in patients with primary hyperparathyroidism, prior to multi-parathyroid gland surgical exploration.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 20 people at Philadelphia. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.772Z"},{"nctId":"NCT07910370","title":"Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation","officialTitle":"Structured Treatment and Resource Efficiency Assessment With Lean Six Sigma Integration for Pulmonary Vein Isolation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"St. Josefs-Hospital Wiesbaden GmbH","sponsorClass":"OTHER","summary":"The STREAMLINE-PVI trial is a prospective, single-center, randomized, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).\n\nA total of 94 patients undergoing first-time PVI will be randomized 1:1 to either PFA or Cryo within standardized Lean Six Sigma (LSS)-optimized procedural workflows. The primary objective is to evaluate whether PFA reduces total procedure duration by at least 20% compared with Cryo without compromising safety or efficacy.\n\nSecondary outcomes include post-procedural recovery, readiness for same-day discharge, atrial arrhythmia recurrence, AF burden, and procedural complications during a 12-month follow-up period.","conditions":["Atrial Fibrillation (AF)"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Pulsed Field Ablation (PFA)"},{"type":"PROCEDURE","name":"Cryoballoon Ablation (Cryo)"}],"enrollment":94,"startDate":"2026-10-26","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Willingness to participate and ability to provide informed consent\n* Atrial fibrillation diagnosed within the past 2 years\n* Scheduled for first-time pulmonary vein isolation (PVI)\n\nExclusion Criteria:\n\n* Previous catheter ablation for atrial fibrillation\n* Reversible cause of atrial fibrillation (e.g., thyrotoxicosis, alcohol ingestion)\n* Coexisting non-pulmonary vein-dependent atrial tachycardia\n* Heart failure with reduced ejection fraction (LVEF ≤40%)\n* Indication for pacemaker or implantable cardioverter-defibrillator (ICD) implantation\n* Severe mitral stenosis or regurgitation, or previous mitral valve repair or replacement\n* Known intracardiac thrombus formation despite continuous oral anticoagulation for more than 4 weeks\n* Incessant ventricular tachycardia\n* Surgical coronary revascularization within the previous 30 days\n* Myocardial infarction within the previous 30 days\n* Ongoing triple antithrombotic therapy following percutaneous coronary intervention (PCI)\n* Contraindication to contrast media\n* Contraindication to oral anticoagulation\n* Body mass index (BMI) \\>35 kg/m²\n* Inability to provide written informed consent\n* Life expectancy \\<12 months","locations":[{"facility":"St. Josefs-Hospital Wiesbaden","city":"Wiesbaden","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Joachim R Ehrlich, Prof. Dr.","phone":"+49 611 1771200","email":"jehrlich@joho.de"}],"primaryOutcomes":["Total Procedure Duration"],"hasResults":false,"conditionSlugs":["atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["wiesbaden-germany"],"enrichment":{"headline":"Not a traditional drug phase: Pulsed Field Ablation (PFA) for Atrial Fibrillation (AF)","inPlainEnglish":"The STREAMLINE-PVI trial is a prospective, single-center, randomly assigned, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). A total of 94 patients undergoing first-time PVI will be randomly assigned 1:1 to either PFA or Cryo within standardized Lean Six Sigma (LSS)-optimized procedural workflows.","whoItsFor":["Ages 18 Years to any","Atrial fibrillation diagnosed within the past 2 years","Scheduled for first-time pulmonary vein isolation (PVI)"],"whoShouldSkip":["Previous catheter ablation for atrial fibrillation","Reversible cause of atrial fibrillation (e.g., thyrotoxicosis, alcohol ingestion)","Coexisting non-pulmonary vein-dependent atrial tachycardia","Heart failure with reduced ejection fraction (LVEF ≤40%)","Indication for pacemaker or implantable cardioverter-defibrillator (ICD) implantation","Severe mitral stenosis or regurgitation, or previous mitral valve repair or replacement","Known intracardiac thrombus formation despite continuous oral anticoagulation for more than 4 weeks"],"whatHappens":"If you join, the listed intervention(s) are Pulsed Field Ablation (PFA), or Cryoballoon Ablation (Cryo). The registry lists allocation as randomized. The STREAMLINE-PVI trial is a prospective, single-center, randomly assigned, open-label clinical trial comparing pulsed field ablation (PFA) with cryoballoon ablation (Cryo) for pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 94 people at Wiesbaden. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.746Z"},{"nctId":"NCT07910409","title":"Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases","officialTitle":"Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Beijing Chao Yang Hospital","sponsorClass":"OTHER","summary":"This is a multicenter, observational study aiming to construct and validate an Impulse Oscillometry (IOS)-based platform for the screening, diagnosis, and management of chronic airway diseases (COPD and asthma). The study consists of two phases. Phase 1 is a cross-sectional study to build and validate diagnostic models for COPD and asthma using IOS parameters, with respiratory specialists' clinical diagnosis as the gold standard. Phase 2 is a 48-week prospective cohort study to develop a prognostic model for predicting acute exacerbation risk based on IOS parameters. Approximately 2,800 participants will be enrolled from hospitals, physical examination centers, and community health centers across China. The results will provide evidence for the clinical application of IOS technology in chronic airway disease management.","conditions":["Chronic Obstructive Pulmonary Disease (COPD)","Asthma (Diagnosis)"],"keywords":["Impulse Oscillometry","IOS","COPD","Asthma","Diagnosis","Prognosis"],"interventions":[],"enrollment":2800,"startDate":"2026-04-01","completionDate":"2028-06-30","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Phase 1: Participants from respiratory and critical care medicine outpatient clinics, physical examination centers, and community health centers; conscious, with basic communication and comprehension ability, able to cooperate with questionnaires and IOS/spirometry examinations; willing to sign written informed consent.\n* Phase 2: Patients with confirmed stable COPD (meeting GOLD criteria) or asthma (meeting GINA criteria); stable disease defined as no acute exacerbation within the past 4 weeks, without the need for systemic glucocorticoids or increased routine medication; willing to sign written informed consent.\n\nExclusion Criteria:\n\n* Phase 1: Respiratory infection within the past 4 weeks; other severe pulmonary diseases affecting lung function (e.g., active tuberculosis, extensive bronchiectasis, pulmonary fibrosis, chest wall deformity, lung cancer); severe dysfunction of heart, brain, liver, or kidney (e.g., NYHA class III-IV, severe arrhythmia, uremia) or uncontrolled malignancy; cognitive impairment or psychiatric disorders; pregnancy or lactation; contraindications to pulmonary function tests.\n* Phase 2: Comorbid severe respiratory diseases (e.g., bronchiectasis, pulmonary fibrosis, lung cancer, active tuberculosis); severe heart, liver, or kidney dysfunction (e.g., NYHA class III-IV, end-stage liver disease, dialysis-dependent renal disease); conditions affecting pulmonary function test accuracy (e.g., chest wall deformity, pneumothorax, recent thoracic or abdominal surgery); severe cognitive impairment, psychiatric disorders, or communication barriers; planned relocation within 1 year or inability to complete regular follow-up; pregnancy or lactation.","locations":[{"facility":"eijing Chao-Yang Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kewu Huang, MD","phone":"+86-13601234681","email":"kewuhuang@126.com"}],"primaryOutcomes":["Diagnostic performance of IOS-based models for COPD and asthma","Acute exacerbation events"],"hasResults":false,"conditionSlugs":["als","asthma","copd"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and M…","inPlainEnglish":"This is a multicenter, watch-and-measure (no experimental treatment required) study aiming to construct and validate an Impulse Oscillometry (IOS)-based platform for the screening, diagnosis, and management of chronic airway diseases (COPD and asthma). Phase 1 is a cross-sectional study to build and validate diagnostic models for COPD and asthma using IOS parameters, with respiratory specialists' clinical diagnosis as the gold standard.","whoItsFor":["Ages 18 Years to 80 Years","Age 18 to 80 years"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 2,800 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.350Z"},{"nctId":"NCT07910474","title":"FES PET/MRI for Occult Disease in Lobular Breast Cancer","officialTitle":"A Diagnostic Accuracy Study of FES PET/MRI for the Detection of Occult Disease in Lobular Breast Cancer","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Wisconsin, Madison","sponsorClass":"OTHER","summary":"The investigators hope to learn if lobular breast cancer can be identified using a special procedure called a positron emission tomography (PET) magnetic resonance image (MRI) scan, collectively a PET/MRI scan, that uses a radioactive imaging agent called Fluorine 18 fluoroestradiol (18F-FES). This procedure may be able to define the extent of disease more clearly than the standard of care breast imaging exams. 30 participants will be enrolled and be on study for up to 6 months.","conditions":["Lobular Breast Carcinoma"],"keywords":["diagnostic","imaging","18F-FES","invasive lobular cancer"],"interventions":[{"type":"DRUG","name":"18Fluoroestradiol (18F-FES)"},{"type":"DEVICE","name":"MRI"},{"type":"DRUG","name":"Gadolinium-based contrast agent (GBCA)"}],"enrollment":30,"startDate":"2026-11","completionDate":"2028-11","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults assigned female sex at birth\n* Newly diagnosed ILC confirmed on core-needle biopsy (greater than or equal to 1 percent ER staining per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines)\n* have undergone or will undergo standard-of-care (SOC) clinical and imaging assessments (e.g., mammography, ultrasound, breast MRI)\n* planning for mastectomy or breast-conserving surgery within 12 months of their initial diagnosis\n* Provision of signed and dated informed consent form\n\nExclusion Criteria:\n\n* Patients with history of ipsilateral axillary lymph node dissection\n* Patients who received anti-estrogen therapy such as selective estrogen receptor degrader (SERD, e.g., fulvestrant, elacestrant) in the last 28 weeks or selective estrogen receptor modulator (SERM, e.g., tamoxifen, raloxifene) in the last 8 weeks.\n* Pregnancy or breastfeeding\n* Patients with known allergic or hypersensitivity reactions to previously administered GBCAs or related drug.\n* Patients with a contraindication to MRI, or who cannot be positioned within the scanner because their body weight or diameter exceeds the scanner limits.\n* Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:\n\n  1. The subject has their own prescription for the medication\n  2. The informed consent process is conducted prior to the self-administration of this medication\n  3. They come to the research visit with a driver\n* Concurrent participation in another clinical study that, in the judgment of the PI, would interfere with study procedures, endpoint assessment, interpretation of imaging findings, or participant safety.","locations":[{"facility":"UW Carbone Cancer Center","city":"Madison","state":"Wisconsin","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Cancer Connect","phone":"800-622-8922","email":"clinicaltrials@cancer.wisc.edu"}],"primaryOutcomes":["Percent of Participants where Disease is Detected using 18F-FES-PET/MRI"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["madison-wisconsin"],"enrichment":{"headline":"Phase 4: testing 18Fluoroestradiol (18F-FES) for Lobular Breast Carcinoma","inPlainEnglish":"The investigators hope to learn if lobular breast cancer can be identified using a special procedure called a positron emission tomography (PET) magnetic resonance image (MRI) scan, collectively a PET/MRI scan, that uses a radioactive imaging agent called Fluorine 18 fluoroestradiol (18F-FES). This procedure may be able to define the extent of disease more clearly than the standard of care breast imaging exams.","whoItsFor":["Ages 18 Years to any","Women only","Adults assigned female sex at birth","Newly diagnosed ILC confirmed on core-needle biopsy (greater than or equal to 1 percent ER staining per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines)","have undergone or will undergo standard-of-care (SOC) clinical and imaging assessments (e.g., mammography, ultrasound, breast MRI)","planning for mastectomy or breast-conserving surgery within 12 months of their initial diagnosis"],"whoShouldSkip":["Patients with history of ipsilateral axillary lymph node dissection","Patients who received anti-estrogen therapy such as selective estrogen receptor degrader (SERD, e.g., fulvestrant, elacestrant) in the last 28 weeks or selective estrogen receptor modulator (SERM, e.g., tamoxifen, raloxifene) in the last 8 weeks","Pregnancy or breastfeeding","Patients with known allergic or hypersensitivity reactions to previously administered GBCAs or related drug","Patients with a contraindication to MRI, or who cannot be positioned within the scanner because their body weight or diameter exceeds the scanner limits","Patients requiring intravenous (IV) conscious sedation for imaging are not eligible; patients requiring mild, oral anxiolytics for the clinical MRI will be allowed to participate as long as the following criteria are met:","The subject has their own prescription for the medication"],"whatHappens":"If you join, the listed intervention(s) are 18Fluoroestradiol (18F-FES), MRI, or Gadolinium-based contrast agent (GBCA). The registry lists allocation as na. The investigators hope to learn if lobular breast cancer can be identified using a special procedure called a positron emission tomography (PET) magnetic resonance image (MRI) scan, collectively a PET/MRI scan, that uses a radioactive imaging agent called Fluorine 18 fluoroestradiol (18F-FES).","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 30 people at Madison. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.959Z"},{"nctId":"NCT07910773","title":"Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial","officialTitle":"Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of California, San Francisco","sponsorClass":"OTHER","summary":"The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.\n\nResearchers will compare two goals for the top blood pressure number (systolic blood pressure): below 120 mmHg versus below 140 mmHg.This pilot study will help plan a larger trial in the future.\n\nParticipants will:\n\n* Be assigned by chance to one of the two blood pressure goals.\n* Have their blood pressure measured at clinic visits about every two weeks.\n* Work with their kidney doctor on recommended changes to fluid management, peritoneal dialysis treatment, or blood pressure medicines to reach their assigned goal.\n* Be part of the study for about four and a half months.","conditions":["End Stage Kidney Disease (ESKD)","Hypertension (HTN)","Peritoneal Dialysis (PD)"],"keywords":["Target blood pressure","Peritoneal dialysis","End stage kidney disease","Hypertension"],"interventions":[{"type":"OTHER","name":"Target systolic blood pressure <120 mmHg."},{"type":"OTHER","name":"Target systolic blood pressure <140 mmHg"}],"enrollment":10,"startDate":"2026-10-30","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Undergoing regular PD for treatment of ESKD.\n* On PD for ≥ 4 months. (We do not plan to enroll patients within the first 3 months of PD initiation because there can be large fluctuations in volume status and BP readings before patient coming into more of a steady state. We then require participants to have at least 1 month of BP data to allow calculation of an average pre-enrollment BP for screening for study entry.)\n* Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening.\n* Able to measure brachial BP.\n\nExclusion Criteria:\n\n* Planned transplant or HD transition \\< 4.5 months (the duration of study).\n* Estimated life expectancy \\< 4.5 months (also determined by asking the treating nephrologist).\n* Participation in another clinical trial that may affect BP management.\n* Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis.\n* Incarceration or institutionalized living which may prohibit measurement of home BP.\n* Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data.","locations":[{"facility":"Satellite Healthcare - Daly City","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zuckerberg San Francisco General Hospital","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Satellite Healthcare - San Francisco Geary","city":"San Francisco","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kashvi Gupta, MD, MPH","phone":"734-546-4545","email":"Kashvi.Gupta@ucsf.edu"}],"primaryOutcomes":["Feasibility of enrolling participants"],"hasResults":false,"conditionSlugs":["als","hypertension"],"drugSlugs":[],"locationSlugs":["san-francisco-california"],"enrichment":{"headline":"Not a traditional drug phase: Target systolic blood pressure <120 mmHg. for End Stage Kidney Disease (ESKD)","inPlainEnglish":"The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis. The main questions it aims to answer are whether eligible patients can be recruited for the study.","whoItsFor":["Ages 18 Years to any","Undergoing regular PD for treatment of ESKD","Diagnosis of HTN defined as being on antihypertensive medications or having routine clinic SBP ≥ 140 mmHg averaged over prior one month to screening","Able to measure brachial BP"],"whoShouldSkip":["Planned transplant or HD transition \\< 4.5 months (the duration of study)","Estimated life expectancy \\< 4.5 months (also determined by asking the treating nephrologist)","Participation in another clinical trial that may affect BP management","Pregnancy, anticipated pregnancy, or breastfeeding as this will limit the use of certain antihypertension medications in the study and pose additional risks to the patient and many pregnant patients are transitioned over to hemodialysis","Incarceration or institutionalized living which may prohibit measurement of home BP","Presence of a condition or abnormality that, in the opinion of the study team or treating nephrologist, would compromise the safety of the patient or the quality of the data"],"whatHappens":"If you join, the listed intervention(s) are Target systolic blood pressure <120 mmHg., or Target systolic blood pressure <140 mmHg. The registry lists allocation as randomized. The GOAL-BP pilot study will help determine whether a study comparing two blood pressure goals can be carried out in adults with end-stage kidney disease and high blood pressure who receive peritoneal dialysis.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.491Z"},{"nctId":"NCT07911124","title":"Ticagrelor for Inflammation and Cardiovascular Risk in Patients With Chronic Kidney Disease","officialTitle":"A Randomized Double-Blind Placebo-Controlled Phase II Clinical Trial to Investigate the Effect of Platelet Inhibition With Ticagrelor to Reduce Inflammation and Surrogate Cardiovascular Markers in Chronic Kidney Disease","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"University of Arkansas","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD. Decreasing inflammation may decrease the risk of heart disease.\n\nThe main questions it aims to answer are:\n\n* Why are patients with CKD at increased risk for heart disease and how to reduce that risk in the future.\n* If there could be new treatment options for managing inflammation in blood of patients with CKD.\n\nResearchers will compare Ticagrelor to a Placebo (a look-alike substance that contains no drug) to see if ticagrelor decreases inflammation in adult patients with CKD. A comparator (control) group not receiving the drug/placebo will consist of adults without CKD.\n\nParticipants with CKD will:\n\n* Take ticagrelor 90 mg or placebo orally twice daily for 42 days\n* Visit the clinic once every 2 weeks for checkups, tests, and bloodwork\n* Participation will last approximately 12 weeks\n\nParticipants without CKD (control group) will visit the clinic twice (7 weeks apart) to provide information and bloodwork. Participation will last approximately 7 weeks with additional optional visits.","conditions":["Chronic Kidney Disease (CKD)"],"keywords":["Chronic Kidney Disease","CKD","Ticagrelor","Inflammation"],"interventions":[{"type":"DRUG","name":"Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist"},{"type":"DRUG","name":"Placebo"}],"enrollment":230,"startDate":"2026-11","completionDate":"2030-12","sex":"ALL","minAge":"21 Years","maxAge":"75 Years","healthyVolunteers":true,"eligibilityRaw":"INCLUSION CRITERIA\n\nPopulation 1: CKD Participants\n\n* Provision of signed and dated written informed consent.\n* Age 21 to 75 years at the time of screening, inclusive.\n* Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) \\<45 ml/min/1.73m² as calculated by the CKD-EPI equation, confirmed from medical records or laboratory results.\n* Currently receiving the maximally tolerated or labeled dose of a renin-angiotensin-aldosterone system inhibitor (RAASi) as guideline-directed medical therapy (GDMT), or documentation of the reason for not receiving RAASi (e.g., intolerance, contraindication).\n\nPopulation 2: Control Participants\n\n* Provision of signed and dated written informed consent.\n* Age 21 to 75 years at the time of screening, inclusive.\n* Normal kidney function, defined as eGFR \\>60 ml/min/1.73m² (CKD-EPI equation) and urinary albumin-to-creatinine ratio (UACR) \\<30 mg/g, confirmed from medical records or laboratory results.\n\nEXCLUSION CRITERIA\n\nPopulation 1: CKD Participants\n\n* Unwilling or unable to participate in the protocol or comply with its components.\n* End-stage renal disease (defined as receiving peritoneal dialysis or hemodialysis) or any prior solid organ or bone marrow transplant. Rationale: dialysis directly affects platelet function and would confound the primary endpoint.\n* Acute kidney injury superimposed on CKD at the time of screening.\n* Acute coronary syndrome, acute myocardial infarction, or acute cerebrovascular event within 6 months prior to screening. Rationale: these participants are likely receiving P2Y12 inhibitor therapy, and their enrollment would confound the primary endpoint.\n* Hospitalization, major surgery, or use of systemic antibiotics within 1 month prior to screening. Rationale: these events are potentially associated with acute inflammatory changes that would confound baseline cytokine measurements.\n* Blood dyscrasias, active bleeding of any site, or a known bleeding diathesis.\n* History of gastrointestinal bleeding within 6 months prior to screening.\n* Concomitant use of any antiplatelet agent other than aspirin (e.g., clopidogrel, prasugrel, dipyridamole) or any antithrombotic or anticoagulant medication (e.g., warfarin, direct oral anticoagulants) at the time of screening or anticipated need during the study period.\n* Hemoglobin \\<8 g/dL, white blood cell count \\>20,000/μL, or platelet count \\<50,000/μL at the time of screening.\n* Any active malignancy requiring systemic treatment, or chronic liver disease (including cirrhosis or hepatitis with active inflammation).\n* Current use of immunosuppressive medications (e.g., corticosteroids, calcineurin inhibitors, mycophenolate). Rationale: these medications independently alter cytokine profiles and leukocyte gene expression, confounding the primary and mechanistic endpoints.\n* Age older than 75 years. Rationale: individuals older than 75 years carry a substantially higher risk of bleeding on antiplatelet therapy and are excluded for participant safety.\n* Pregnancy or breastfeeding at the time of screening or plans to become pregnant during the study period. Women of reproductive potential will undergo a urine pregnancy test at screening (Visit 1); a positive result excludes from participation.\n* Known severe hypersensitivity or allergy to ticagrelor or any component of the study drug formulation.\n* Treatment with another investigational drug or other intervention ongoing, or within a month of randomization.\n* Ongoing treatment for infection.\n\nPopulation 2: Control Participants\n\n* Any known diagnosis of chronic kidney disease, eGFR ≤60 ml/min/1.73m², or UACR ≥30 mg/g.\n* Inability to sign consent and HIPAA form. Legal Authorized Representatives are not allowed to sign the consent form.\n* Unwillingness or inability to participate in the protocol or comply with any of its components.\n* Any current use of aspirin or NSAIDs and not willing to hold.\n* Current use of antibiotics or ongoing infection.","locations":[{"facility":"University of Arkansas for Medical Sciences","city":"Little Rock","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jonathan Young","phone":"501-526-7984","email":"jayoung@uams.edu"},{"name":"David Avery","phone":"501-214-2101","email":"DAAvery@uams.edu"}],"primaryOutcomes":["Aim 1: post-treatment IL-1β value"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["little-rock-arkansas"],"enrichment":{"headline":"Phase 2: testing Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist for Chronic Kidney Disease (CKD)","inPlainEnglish":"The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD.","whoItsFor":["Ages 21 Years to 75 Years","Population 1: CKD Participants","Age 21 to 75 years at the time of screening, inclusive","Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) \\<45 ml/min/1.73m² as calculated by the CKD-EPI equation, confirmed from medical records or laboratory results","Currently receiving the maximally tolerated or labeled dose of a renin-angiotensin-aldosterone system inhibitor (RAASi) as guideline-directed medical therapy (GDMT), or documentation of the reason for not receiving RAASi (e.g., intolerance, contraindication)","Population 2: Control Participants","Normal kidney function, defined as eGFR \\>60 ml/min/1.73m² (CKD-EPI equation) and urinary albumin-to-creatinine ratio (UACR) \\<30 mg/g, confirmed from medical records or laboratory results"],"whoShouldSkip":["Population 1: CKD Participants","Unwilling or unable to participate in the protocol or comply with its components","End-stage renal disease (defined as receiving peritoneal dialysis or hemodialysis) or any prior solid organ or bone marrow transplant. Rationale: dialysis directly affects platelet function and would confound the primary endpoint","Acute kidney injury superimposed on CKD at the time of screening","Acute coronary syndrome, acute myocardial infarction, or acute cerebrovascular event within 6 months prior to screening. Rationale: these participants are likely receiving P2Y12 inhibitor therapy, and their enrollment would confound the primary endpoint","Hospitalization, major surgery, or use of systemic antibiotics within 1 month prior to screening. Rationale: these events are potentially associated with acute inflammatory changes that would confound baseline cytokine measurements","Blood dyscrasias, active bleeding of any site, or a known bleeding diathesis"],"whatHappens":"If you join, the listed intervention(s) are Ticagrelor: an oral, direct-acting, reversibly binding P2Y12 receptor antagonist, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 230 people at Little Rock. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.487Z"},{"nctId":"NCT07911449","title":"Osimertinib Plus Stereotactic Radiosurgery/Radiotherapy for EGFR-Mutant Non-Small Cell Lung Cancer With Symptomatic Brain Metastases","officialTitle":"Osimertinib Combined With LINAC-Based Stereotactic Radiosurgery or Stereotactic Radiotherapy for Brain Metastases in EGFR-Mutant Stage IV Non-Small Cell Lung Cancer: A Prospective Single-Arm Interventional Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Cho Ray Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether adding stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT), delivered on a linear accelerator (LINAC), to osimertinib improves control of brain metastases in adults with stage IV non-small cell lung cancer (NSCLC) carrying a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) whose brain metastases cause neurological symptoms (present at diagnosis or arising during osimertinib treatment). The main questions it aims to answer are:\n\n* What proportion of participants achieve an intracranial objective response (complete or partial response by RANO-BM criteria)?\n* How long do participants live without intracranial or overall disease progression, how long do they live overall, and what side effects occur with the combined treatment?\n\nParticipants will:\n\n* Take osimertinib 80 mg by mouth once daily (or continue it if they have already started it).\n* Receive SRS (1 fraction) or SRT (3 or 5 fractions) to all brain metastases (1 to 4 lesions, each 4 cm or smaller) at Cho Ray Hospital, Ho Chi Minh City, Vietnam.\n* Have brain MRI (or contrast-enhanced CT if MRI is not possible) and chest-abdomen CT every 12 weeks, monthly clinic visits to check for side effects, and blood tests, ECG and echocardiography every 12 weeks.","conditions":["Non-Small Cell Lung Cancer","Brain Metastases From Non-small Cell Lung Cancer (NSCLC)","EGFR Activating Mutation"],"keywords":["osimertinib","stereotactic radiosurgery; fractionated stereotactic radiotherapy","EGFR exon 19 deletion; EGFR L858R","symptomatic brain metastases","Vietnam"],"interventions":[{"type":"DRUG","name":"Osimertinib"},{"type":"RADIATION","name":"Stereotactic Radiosurgery"}],"enrollment":41,"startDate":"2026-02-27","completionDate":"2028-10-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older.\n* ECOG performance status 0-2.\n* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the lung, stage IV (AJCC 8th edition).\n* Sensitizing EGFR mutation: exon 19 deletion or exon 21 L858R point mutation.\n* Brain metastases diagnosed on contrast-enhanced MRI, CT or 18F-FDG PET-CT.\n* Symptomatic brain metastases: brain metastases accompanied by neurological symptoms, either (a) present at diagnosis of brain metastases, or (b) arising while the patient is receiving osimertinib. Qualifying symptoms: raised intracranial pressure (headache, nausea/vomiting); focal neurological deficits (limb weakness or paralysis, sensory disturbance, visual disturbance, language disturbance, seizure, imbalance); cognitive-behavioural changes (memory or concentration decline, personality or mood change).\n* 1 to 4 brain metastases, each 4 cm or smaller in maximum diameter.\n* Written informed consent.\n\nExclusion Criteria:\n\n* History of a second malignancy.\n* Pregnancy.\n* Asymptomatic brain metastases (no neurological symptoms).\n* Leptomeningeal metastases.\n* Prior treatment with a first- or second-generation EGFR-TKI.\n* Prior stereotactic radiosurgery or whole-brain radiotherapy.\n* Discontinuation of osimertinib before completing at least 3 months of treatment.","locations":[{"facility":"Cho Ray Hospital - Department of Medical and Radiation Oncology, Oncology Center","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"HUNG HA GIA NGUYEN, MD, MSc","phone":"+84 978404343","email":"NHGHUNG@GMAIL.COM"}],"primaryOutcomes":["Intracranial objective response rate (iORR)","Intracranial disease control rate (iDCR)"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":["osimertinib"],"locationSlugs":["ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Phase 2: testing Osimertinib for Non-Small Cell Lung Cancer","inPlainEnglish":"The goal of this clinical trial is to learn whether adding stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT), delivered on a linear accelerator (LINAC), to osimertinib improves control of brain metastases in adults with stage IV non-small cell lung cancer (NSCLC) carrying a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) whose brain metastases cause neurological symptoms (present at diagnosis or arising during osimertinib treatment). The main questions it aims to answer are: * What proportion of participants achieve an intracranial objective response (complete or partial response by RANO-BM criteria)?","whoItsFor":["Ages 18 Years to any","Age 18 years or older","how well you can do daily activities (ECOG score) 0-2","Histologically confirmed adenocarcinoma or squamous cell carcinoma of the lung, stage IV (AJCC 8th edition)","Sensitizing EGFR mutation: exon 19 deletion or exon 21 L858R point mutation","Brain metastases diagnosed on contrast-enhanced MRI, CT or 18F-FDG PET-CT","1 to 4 brain metastases, each 4 cm or smaller in maximum diameter"],"whoShouldSkip":["History of a second malignancy","Asymptomatic brain metastases (no neurological symptoms)","Leptomeningeal metastases","Prior treatment with a first- or second-generation EGFR-TKI","Prior stereotactic radiosurgery or whole-brain radiotherapy","Discontinuation of osimertinib before completing at least 3 months of treatment"],"whatHappens":"If you join, the listed intervention(s) are Osimertinib, or Stereotactic Radiosurgery. The registry lists allocation as na. The goal of this clinical trial is to learn whether adding stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (SRT), delivered on a linear accelerator (LINAC), to osimertinib improves control of brain metastases in adults with stage IV non-small cell lung cancer (NSCLC) carrying a sensitizing EGFR mutation (exon 19 deletion or exon 21 L858R) whose brain metastases cause neurological symptoms (present at diagnosis or arising during osimertinib treatment).","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 41 people at Ho Chi Minh City. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:22.676Z"},{"nctId":"NCT07911605","title":"Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke","officialTitle":"Sustained Neuroprotective Effects of Short-Term External Trigeminal Nerve Stimulation in Acute Ischemic Stroke: A Randomized, Sham-Controlled Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Xidian University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the efficacy of a 5-day short-course external trigeminal nerve stimulation (eTNS) regimen in patients with acute ischemic stroke. The main questions it aims to answer are whether a 5-day eTNS intervention can significantly improve the neurological response rate at Day 30 compared to sham stimulation, and whether this short-course treatment yields sustained improvements in neuropsychiatric symptoms (depression, anxiety, and insomnia) over a 90-day follow-up period. Researchers will compare the active eTNS group to a sham-controlled group to see if the 5-day stimulation provides a sustained neuroprotective effect. Participants will be randomly assigned (1:1) to receive either active eTNS or sham eTNS for 5 consecutive nights within 72 hours of stroke onset, in addition to standard medical therapy, and will undergo neurological and functional assessments (NIHSS, mRS, BI) at baseline (Day 0), Day 5, Day 30, Day 60, and Day 90, as well as complete neuropsychiatric questionnaires (PHQ-9, GAD-7, and ISI) during the follow-up visits to evaluate their mood and sleep quality. In addition, brain imaging data and blood samples will be collected at baseline (Day 0) and after the 5-day intervention (Day 5) for exploratory analyses of infarct volume and peripheral inflammatory markers.","conditions":["Acute Ischemic Stroke"],"keywords":[],"interventions":[{"type":"DEVICE","name":"External trigeminal nerve stimulation"},{"type":"DEVICE","name":"Sham eTNS"}],"enrollment":60,"startDate":"2026-11-03","completionDate":"2027-01-20","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age over 18 years;\n* Medically diagnosed with acute ischemic stroke;\n* Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;\n* NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;\n* Signed informed consent form;\n* Ability and willingness to comply with the study requirements.\n\nExclusion Criteria:\n\n* History of ischemic or hemorrhagic stroke within the past 3 months;\n* Patients in a comatose state;\n* severe comorbidities;\n* Pregnant or breastfeeding women;\n* Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain;\n* Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;","locations":[{"facility":"Shaanxi Provincial People' s Hospital","city":"Xi'an","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rui Zhao","phone":"86-029-85251331-2610","email":"zhaorui861221@163.com"}],"primaryOutcomes":["Response Rate as Assessed by the National Institutes of Health Stroke Scale (NIHSS) at 30 Days"],"hasResults":false,"conditionSlugs":["stroke","depression"],"drugSlugs":[],"locationSlugs":["xian-china"],"enrichment":{"headline":"Not a traditional drug phase: External trigeminal nerve stimulation for Acute Ischemic Stroke","inPlainEnglish":"The goal of this clinical trial is to measure the how well it works of a 5-day short-course external trigeminal nerve stimulation (eTNS) regimen in patients with acute ischemic stroke. The main questions it aims to answer are whether a 5-day eTNS intervention can significantly improve the neurological response rate at Day 30 compared to sham stimulation, and whether this short-course treatment yields sustained improvements in neuropsychiatric symptoms (depression, anxiety, and insomnia) over a 90-day follow-up period.","whoItsFor":["Ages 18 Years to any","Medically diagnosed with acute ischemic stroke;","Ability to receive trigeminal nerve stimulation within 72 hours post-stroke onset;","NIHSS (National Institutes of Health Stroke Scale) score ≥ 4;","Ability and willingness to comply with the study requirements"],"whoShouldSkip":["History of ischemic or hemorrhagic stroke within the past 3 months;","Patients in a comatose state;","severe comorbidities;","Pregnant or breastfeeding women;","Exclusion from trigeminal nerve stimulation: patients with trigeminal neuralgia or facial pain;","Current or recent participation in other neuromodulation stimulation therapies within the past 3 months;"],"whatHappens":"If you join, the listed intervention(s) are External trigeminal nerve stimulation, or Sham eTNS. The registry lists allocation as randomized. The goal of this clinical trial is to measure the how well it works of a 5-day short-course external trigeminal nerve stimulation (eTNS) regimen in patients with acute ischemic stroke.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Xi'an. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.211Z"},{"nctId":"NCT07911670","title":"Exploratory Clinical Trial of UX-DA003 Injection for the Treatment of Patients With Parkinson's Disease","officialTitle":"Exploratory Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of UX-DA003 Injection (Human iPSC-derived Midbrain Dopaminergic Neural Precursor Cells) in Patients With Parkinson's Disease","status":"RECRUITING","phases":["EARLY_PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"The First Affiliated Hospital of Anhui Medical University","sponsorClass":"OTHER","summary":"This clinical study is designed to explore the safety and tolerability of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.","conditions":["PARKINSON DISEASE (Disorder)"],"keywords":["allogeneic iPSC derived mDAPs","Parkinson's Disease"],"interventions":[{"type":"DRUG","name":"UX-DA003"}],"enrollment":12,"startDate":"2026-11-23","completionDate":"2029-03","sex":"ALL","minAge":"30 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* \\- Aged between 30 and 75 years, regardless of gender\n* Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years\n* Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the efficacy has significantly declined\n* Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%\n* The modified H\\&Y staging (Off period) of ≥2.5 and ≤4, with total daily \"off\" time \\>2 hours\n* Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening\n* Good physical condition or stable concomitant diseases\n\nExclusion Criteria:\n\n* The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome\n* Severe systemic diseases or functional impairments\n* Evidence of active infection or chronic infection, which may pose a risk to the subject\n* Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders\n* Subjects with a history of brain injuries, cerebral vascular malformations, hydrocephalus, brain tumors, or other brain damages as shown by previous Head CT/MRI scans, or subjects with abnormal brain imaging in the striatum or other brain regions that significantly increase surgical risks\n* Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other interventional clinical trials within the last 3 months\n* Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them\n* Pregnant or breastfeeding women","locations":[{"facility":"The First Affiliated Hospital of Anhui Medical University Recruiting","city":"Hefei","state":"Anhui","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jinmei Sun, MD","phone":"+86 0551 62923704","email":"sunjinmei0628@163.com"}],"primaryOutcomes":["Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)"],"hasResults":false,"conditionSlugs":["parkinson","als"],"drugSlugs":[],"locationSlugs":["hefei-china"],"enrichment":{"headline":"Early phase 1: testing UX-DA003 for PARKINSON DISEASE (Disorder)","inPlainEnglish":"This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003. It will also explore if UX-DA003 works to improve motor function in subjects with Parkinson's disease.","whoItsFor":["Ages 30 Years to 75 Years","\\- Aged between 30 and 75 years, regardless of gender","Diagnosed with Parkinson's disease conforming to relevant clinical diagnostic standards with a medical history of 5-20 years","Having received standard anti-PD treatment and been given optimal anti-PD treatment under the guidance of the investigator, but the how well it works has significantly declined","Good response to levodopa medications, the levodopa challenge test (LCT) shows that the maximum improvement rate of the UPDRS-III score exceeds 30%","The modified H\\&Y staging (Off period) of ≥2.5 and ≤4, with total daily \"off\" time \\>2 hours","Stable dose of anti-Parkinson' disease drugs for at least 4 weeks prior to screening","Good physical condition or stable concomitant diseases"],"whoShouldSkip":["The subjects with atypical Parkinson's syndrome or secondary Parkinson's syndrome","Severe systemic diseases or functional impairments","Evidence of active infection or chronic infection, which may pose a risk to the subject","Severe concomitant central nervous system diseases or severe cognitive and psychiatric disorders","Subjects who have participated in clinical trials for stem cell therapy or gene therapy for Parkinson's disease, or have participated in other treatment clinical trials within the last 3 months","Subjects with a history of severe allergies or hypersensitivity reactions, known hypersensitivity to the investigational drug or its ancillary materials, or intolerance to them","Pregnant or breastfeeding women"],"whatHappens":"If you join, the listed intervention(s) are UX-DA003. The registry lists allocation as na. This clinical study is designed to explore the whether it is safe and how hard side effects are to live with of UX-DA003.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at Hefei. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.671Z"},{"nctId":"NCT07911878","title":"Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)","officialTitle":"Sviluppo, Validazione e Dati Normativi Della Batteria Italiana Per il Riconoscimento Dei Volti Famosi I-FACE","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istituti Clinici Scientifici Maugeri SpA","sponsorClass":"OTHER","summary":"The I-FACE project aims to develop and validate a battery to assess famous-face recognition in people with neurodegenerative diseases and stroke. It will examine face naming, familiarity, and semantic knowledge, establish norms for the Italian population, and test how well the measures identify recognition difficulties in patients with frontotemporal dementia, Alzheimer's disease, and stroke.","conditions":["Stroke","Alzheimer s Disease","Frontotemporal Degeneration (FTD)"],"keywords":["Famous-face recognition","Neuropsychological assessment","Neurodegenerative diseases"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Neuropsychological assessment using the I-FACE battery"}],"enrollment":300,"startDate":"2025-09-05","completionDate":"2028-01-31","sex":"ALL","minAge":"40 Years","maxAge":"85 Years","healthyVolunteers":true,"eligibilityRaw":"1. Healthy Controls (HC)\n\n   Inclusion Criteria:\n\n   Age 40-85 years. No chronic medical, neurological, or psychiatric conditions, or major depressive episode detected during screening.\n\n   No history of schizophrenia or bipolar disorder in the 5 years prior to screening.\n\n   Mini-Mental State Examination (MMSE) score ≥ 26.\n\n   Exclusion Criteria:\n\n   Uncorrected vision or hearing impairment.\n2. Frontotemporal Dementia (FTD) Patients\n\n   Inclusion Criteria:\n\n   Diagnosis of probable FTD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.\n\n   Exclusion Criteria:\n\n   History of neurological diseases other than FTD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).\n\n   Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders (e.g., autism spectrum), or intellectual disability.\n\n   Dementia severity (CDR) \\> 1.\n3. Alzheimer's Disease (AD) Patients\n\n   Inclusion Criteria:\n\n   Diagnosis of probable AD according to established clinical criteria. Age 40-85 years. Ability to provide informed consent.\n\n   Exclusion Criteria:\n\n   History of neurological diseases other than AD (e.g., stroke, brain tumor, multiple sclerosis, traumatic brain injury).\n\n   Uncorrected vision or hearing impairment. History of serious psychiatric diseases, developmental disorders, or intellectual disability.\n\n   Dementia severity (CDR) \\> 1.\n4. Post-Stroke Patients\n\nInclusion Criteria:\n\nSubacute phase: 1 week to 3 months post-event. Ischemic or hemorrhagic stroke confirmed by neuroimaging and/or clinical judgment.\n\nExclusion Criteria:\n\nHistory of previous stroke or multifocal stroke documented by imaging. Brainstem or cerebellar stroke. History of traumatic brain injury (TBI), seizures, brain tumors, neurodegenerative diseases, or psychiatric disorders.","locations":[{"facility":"ICS Maugeri Sciacca","city":"Sciacca","state":"AG","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Lumezzane","city":"Lumezzane","state":"BS","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"ICS Maugeri Mistretta","city":"Mistretta","state":"ME","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Castel Goffredo","city":"Castel Goffredo","state":"MN","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Montescano","city":"Montescano","state":"PV","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri IRCCS Bari","city":"Bari","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"Istituti Clinici Scientifici Maugeri IRCCS Milano","city":"Milan","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Pavia","city":"Pavia","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Telese Terme","city":"Telese Terme","state":"","country":"Italy","status":"RECRUITING","lat":null,"lon":null},{"facility":"IRCCS Maugeri Veruno","city":"Veruno","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Petronilla Battista, PhD","phone":"+39 0807814331","email":"petronilla.battista@icsmaugeri.it"},{"name":"Serena Tagliente, MSc","phone":"+39 0807814331","email":"serena.tagliente@icsmaugeri.it"}],"primaryOutcomes":["I-FACE total and subtest scores"],"hasResults":false,"conditionSlugs":["alzheimer","stroke"],"drugSlugs":[],"locationSlugs":["sciacca-italy","lumezzane-italy","mistretta-italy","castel-goffredo-italy","montescano-italy","bari-italy","milan-italy","pavia-italy","telese-terme-italy","veruno-italy"],"enrichment":{"headline":"Not a traditional drug phase: Neuropsychological assessment using the I-FACE battery for Stroke","inPlainEnglish":"The I-FACE project aims to develop and validate a battery to assess famous-face recognition in people with neurodegenerative diseases and stroke. It will examine face naming, familiarity, and semantic knowledge, establish norms for the Italian population, and test how well the measures identify recognition difficulties in patients with frontotemporal dementia, Alzheimer's disease, and stroke.","whoItsFor":["Ages 40 Years to 85 Years","Healthy Controls (HC)","Age 40-85 years. No chronic medical, neurological, or psychiatric conditions, or major depressive episode detected during screening","No history of schizophrenia or bipolar disorder in the 5 years prior to screening","Mini-Mental State Examination (MMSE) score ≥ 26"],"whoShouldSkip":["Uncorrected vision or hearing impairment","Frontotemporal Dementia (FTD) Patients","who can join:"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at 10 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.332Z"},{"nctId":"NCT07912593","title":"Phase 1/2, Open-label Study of ETX-929, a KRAS Inhibitor in Participants With Advanced Solid Tumors","officialTitle":"A Phase 1/2, First-in-Human Study of ETX-929, a Pan-KRAS Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With KRAS-Altered Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Ensem Therapeutics","sponsorClass":"INDUSTRY","summary":"This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.","conditions":["Metastatic Colorectal Cancer (CRC)","Pancreatic Ductal Adenocarcinoma (PDAC)","Non-squamous, Non-Small Cell Lung Cancer","Endometrial Adenocarcinoma","Ovarian Adenocarcinoma","Primary Peritoneal Carcinoma"],"keywords":["KRAS"],"interventions":[{"type":"DRUG","name":"ETX-929 dose escalation"},{"type":"DRUG","name":"ETX-929 dose escalation in combination with cetuximab"}],"enrollment":320,"startDate":"2026-10-22","completionDate":"2028-10-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy.\n* Tumor harboring a KRAS mutation.\n* An ECOG performance status score of 0 or 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied.\n* Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement.\n* Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment.\n* Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy.\n* Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.","locations":[{"facility":"NEXT","city":"Fairfax","state":"Virginia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lori Cykowski","phone":"1-617-383-4993","email":"lori.cykowski@Ensemtx.com"}],"primaryOutcomes":["Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B","Evaluate Safety and Tolerability of ETX-929 monotherapy in Part A and ETX-929 plus cetuximab combination therapy in Part B","Select the Recommended Phase 2 Dose(s) (RP2D)","Evaluate efficacy of ETX-929 monotherapy and ETX-929 in combination with cetuximab at the RP2D(s) in Part B and Part D"],"hasResults":false,"conditionSlugs":["lung-cancer","colorectal-cancer"],"drugSlugs":[],"locationSlugs":["fairfax-virginia"],"enrichment":{"headline":"Phase 1 / Phase 2: testing ETX-929 dose escalation for Metastatic Colorectal Cancer (CRC)","inPlainEnglish":"This is a Phase 1/2, open-label, multi-center study to measure the safety, tolerability, PK, PD, and preliminary how well it works of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.","whoItsFor":["Ages 18 Years to any","Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy","Tumor harboring a KRAS mutation","An how well you can do daily activities (ECOG score) score of 0 or 1","Adequate organ function"],"whoShouldSkip":["Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied","Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement","Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment","Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy","Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment"],"whatHappens":"If you join, the listed intervention(s) are ETX-929 dose escalation, or ETX-929 dose escalation in combination with cetuximab. The registry lists allocation as randomized. This is a Phase 1/2, open-label, multi-center study to measure the safety, tolerability, PK, PD, and preliminary how well it works of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 320 people at Fairfax. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.701Z"},{"nctId":"NCT07913139","title":"Functional Capacity in Obstructive Sleep Apnea","officialTitle":"Investigation of Functional Capacity in Patients With Obstructive Sleep Apnea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Karabuk University","sponsorClass":"OTHER","summary":"Obstructive sleep apnea syndrome (OSAS) is a condition characterized by a deterioration in respiratory function and an increase in the activity of accessory respiratory muscles. This condition can affect patients' use of their upper extremities during daily living activities. In this context, our study aimed to examine respiratory function, respiratory muscle strength and endurance, peripheral muscle strength, upper extremity functional exercise capacity, muscle oxygenation, and dyspnea in patients with OSAS, and to compare these parameters with those of healthy controls.","conditions":["Obstructive Sleep Apnea"],"keywords":[],"interventions":[],"enrollment":52,"startDate":"2026-10-28","completionDate":"2027-10-28","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 18-65,\n* Diagnosis of Obstructive Sleep Apnea Syndrome (OSAS) confirmed by a pulmonologist following polysomnography,\n* An Apnea-Hypopnea Index (AHI) ≥5 for OSAS,\n* Willingness to participate in the study.\n\nExclusion Criteria:\n\n* Having severe orthopedic, neurological, or cardiac conditions,\n* Having a diagnosed pulmonary disease,\n* Having a history of-or currently experiencing-a psychiatric or neurological disorder,\n* Not being willing to participate in the study.","locations":[{"facility":"Karabuk University, Physiotherapy and Rehabilitation Application and Research Center","city":"Karabük","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Musa Güneş, PhD","phone":"03704789131","email":"musagunes@karabuk.edu.tr"}],"primaryOutcomes":["Upper extremity exercise capacity"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["karab-k-turkey-t-rkiye"],"enrichment":{"headline":"Functional Capacity in Obstructive Sleep Apnea","inPlainEnglish":"Obstructive sleep apnea syndrome (OSAS) is a condition characterized by a deterioration in respiratory function and an increase in the activity of accessory respiratory muscles. This condition can affect patients' use of their upper extremities during daily living activities.","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of Obstructive Sleep Apnea Syndrome (OSAS) confirmed by a pulmonologist following polysomnography,","An Apnea-Hypopnea Index (AHI) ≥5 for OSAS,","Willingness to participate in the study"],"whoShouldSkip":["Having severe orthopedic, neurological, or cardiac conditions,","Having a diagnosed pulmonary disease,","Having a history of-or currently experiencing-a psychiatric or neurological disorder,"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 52 people at Karabük. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.943Z"},{"nctId":"NCT07913347","title":"Safety, Dosage, and Microbiome Engraftment Study of MGT-006 for Ulcerative Colitis (ROOT Study)","officialTitle":"Phase 1b/2a Study of MGT-006 in Patients With Ulcerative Colitis: A Dose and Preparation Regimen Selection Trial to Assess Safety and Microbiome Engraftment (ROOT Study)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Metagen Therapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine. MGT-006 is an investigational oral capsule containing viable gut microbiota from screened human donors. This study will evaluate the safety and tolerability of MGT-006 in adults with moderately active ulcerative colitis. It will also examine whether gut microbiota from MGT-006 engraft in participants' intestines and explore changes in ulcerative colitis symptoms and inflammation.\n\nThe study has two parts. In Phase 1b, participants will be randomly assigned to receive MGT-006 either without antibiotic pretreatment or after five days of oral vancomycin or AFM (Amoxicillin/Fosfomycin/Metronidazole) pretreatment. MGT-006 will be taken for eight weeks, followed by four weeks of observation. Phase 2a is planned to explore different doses and potentially different dosing regimens of MGT-006, using the pretreatment approach selected from Phase 1b. The final Phase 2a design will depend on the Phase 1b findings and will be specified in an amended protocol before Phase 2a begins.","conditions":["Ulcerative Colitis (UC)","Ulcerative Colitis, Active Moderate"],"keywords":["Ulcerative colitis","Fecal microbiota transplantation","Gut microbiota","FMT","Microbiome engraftment","Oral capsules"],"interventions":[{"type":"DRUG","name":"MGT-006"},{"type":"DRUG","name":"Vancomycin hydrochloride"},{"type":"DRUG","name":"Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole"}],"enrollment":54,"startDate":"2026-07-09","completionDate":"2028-03-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients who understand the contents of this clinical study, sign a written informed consent form, and possess the willingness and capability to participate in all medical examinations, evaluations, and follow-ups related to the study.\n2. Patients aged 18 to 75 years at the time of informed consent\n3. Patients who have been diagnosed with UC through endoscopic and histological examination for at least 12 weeks at the time of final registration\n4. Patients with a modified Mayo Score of 4 to 7 at the time of final registration\n\nExclusion Criteria:\n\n1. Patients with any of the following medical history or complications, or those undergoing concomitant therapy, which the investigator (sub-investigator) to be serious or clinically significant\n2. Patients with past or concurrent malignant tumors; however, cured basal cell carcinoma of the skin is allowed for registration. In addition, breast cancer in remission for \\>= 10 years without recurrence is allowed for registration, and other malignant tumors in remission for \\>= 5 years are allowed for registration if no therapeutic intervention is required and they are in stable condition, as determined by the investigator (sub-investigator).\n3. Patients with pancolitis of \\> 8 years' duration or left-sided colitis of \\> 8 years' duration who have not undergone a surveillance flexible sigmoidoscopy or total colonoscopy (performed according to local standard of care) within 12 months prior to screening to rule out colorectal dysplasia/cancer.\n4. Patients with suspected or confirmed colorectal cancer or high-grade dysplasia.\n5. Patients with any of the following abnormal values in clinical laboratory tests performed within 4 weeks prior to final registration in this clinical study:\n\n   * Patients with a serum creatinine level of \\>= 2.0 mg/dL or a BUN level of \\>= 25 mg/dL\n   * Patients with a total bilirubin level of \\>= 3.0 mg/dL, or an AST (GOT) or ALT (GPT) level of \\>= 100 IU/L\n6. Patients with any of the following will be excluded:\n\n   * HBsAg positive\n   * HCV antibody positive\n   * HIV-1/2 Ag/Ab screening-positive\n7. Patients currently receiving inpatient treatment for UC\n8. Patients suspected to have concurrent active intestinal obstruction or infectious enteritis\n9. Patients with Clostridioides difficile infection (C. difficile infection) (patients in whom the presence or absence of infection is confirmed by NAAT and the result is positive)\n10. Patients with a history of hypersensitivity or allergy to excipients in MGT-006\n11. Patients with any of the following conditions that affect the lower gastrointestinal function\n12. Patients who have failed or been intolerant to \\>= 3 advanced-therapy mechanistic classes for ulcerative colitis (e.g., anti-TNF, anti-integrin, anti-IL-12/23, JAK inhibitor, S1P modulator)\n13. Patients who have used another investigational product within 12 weeks prior to informed consent\n14. Patients with serious allergies or contraindications to any drug used in this study\n15. (Females only) Patients in whom the result of a pregnancy test performed within 4 weeks prior to final registration is positive (if a urine hCG test is positive, a negative serum pregnancy test result should be confirmed)\n16. (Females only) Patients who are pregnant or breastfeeding, or females of childbearing potential unable to use appropriate contraceptive methods from the date of informed consent to 12 weeks post-treatment. (e.g., intrauterine device, diaphragm, partner's use of condom)\n17. (Males only) Patients who are males of reproductive potential (including partners of childbearing potential) unable to use at least one effective contraceptive method from the time of informed consent until 12 weeks after the end of investigational drug administration\n18. Patients judged by the investigator (sub-investigator) to be inappropriate as subjects of this study\n19. (Phase 2a only) Participants who have previously received MGT-006","locations":[{"facility":"GI PROS, Inc.","city":"Naples","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Brigham and Women's Hospital","city":"Boston","state":"Massachusetts","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"NYU Langone Health","city":"New York","state":"New York","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fukuoka University Hospital","city":"Fukuoka","state":"Fukuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sapporo Medical University Hospital","city":"Sapporo","state":"Hokkaido","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kawasaki Medical School Hospital","city":"Kurashiki","state":"Okayama-ken","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kansai Medical University Hospital","city":"Hirakata","state":"Osaka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Hamamatsu University Hospital","city":"Hamamatsu","state":"Shizuoka","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Juntendo University Hospital","city":"Bunkyō-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"The Jikei University Hospital","city":"Minato-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kitasato University Kitasato Institute Hospital","city":"Minato-Ku","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Kyorin University Hospital","city":"Mitaka","state":"Tokyo","country":"Japan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Metagen Therapeutics Clinical development devision","phone":"+81-235-33-9966","email":"mgtx_cdu@metagentx.com"}],"primaryOutcomes":["Safety and tolerability of MGT-006 (adverse events, adverse reactions)"],"hasResults":false,"conditionSlugs":["als","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["naples-florida","boston-massachusetts","new-york-new-york","fukuoka-japan","sapporo-japan","kurashiki-japan","hirakata-japan","hamamatsu-japan","bunky-ku-japan","minato-ku-japan","mitaka-japan"],"enrichment":{"headline":"Phase 1 / Phase 2: testing MGT-006 for Ulcerative Colitis (UC)","inPlainEnglish":"Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine. MGT-006 is an investigational oral capsule containing viable gut microbiota from screened human donors.","whoItsFor":["Ages 18 Years to 75 Years","Patients who have been diagnosed with UC through endoscopic and histological examination for at least 12 weeks at the time of final registration","Patients with a modified Mayo Score of 4 to 7 at the time of final registration"],"whoShouldSkip":["Patients with any of the following medical history or complications, or those undergoing concomitant therapy, which the investigator (sub-investigator) to be serious or clinically significant","Patients with suspected or confirmed colorectal cancer or high-grade dysplasia","Patients with any of the following abnormal values in clinical laboratory tests performed within 4 weeks prior to final registration in this clinical study:","Patients with a serum creatinine level of \\>= 2.0 mg/dL or a BUN level of \\>= 25 mg/dL","Patients with a total bilirubin level of \\>= 3.0 mg/dL, or an AST (GOT) or ALT (GPT) level of \\>= 100 IU/L","Patients with any of the following will be excluded:","HCV antibody positive"],"whatHappens":"If you join, the listed intervention(s) are MGT-006, Vancomycin hydrochloride, or Amoxicillin hydrate/ Fosfomycin calcium hydrate/ Metronidazole. The registry lists allocation as randomized. Ulcerative colitis is a condition that causes inflammation and ulcers in the large intestine.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 54 people at 12 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.210Z"},{"nctId":"NCT07913412","title":"High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes","officialTitle":"High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominence Uveal Melanoma: Modern Radiation Techniques and Outcomes; PRIME: P: Precision R: Radiosurgery I: Intervention M: Minimal Invasive Surgical Approach E: EYESIGHT","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Essen","sponsorClass":"OTHER","summary":"High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors","conditions":["Uveal Melanoma","High-risk Uveal Melanoma","Prominent Uveal Melanoma"],"keywords":["radiotherapy","radiosurgery","minimal invasive","surgery and resection","vision","eyesight"],"interventions":[],"enrollment":250,"startDate":"2019-09-01","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Functional Resectability,\n* Technical Resectability\n* high-prominent uveal melanoma\n\nExclusion Criteria:\n\n* EOE\n* At least in part remaining eye function that can be saved","locations":[{"facility":"Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West","city":"Essen","state":"Germany / NRW","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"Maja Guberina","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Essen","city":"Essen","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Maja Guberina, PD MD","phone":"0201 723 83121","email":"maja.guberina@uk-essen.de"}],"primaryOutcomes":["Local control","Function: Visual acuity:","Quality of Life, ophthalmic cancer-specific quality of life","Progression Free Survival","Overall Survival","Function: Visual acuity:","Function: Visual field","Quality of Life general quality of life","Function: Retinal Nerve Fiber Layer","Cornea","Cornea","Corneal overall outcome classification"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":[],"locationSlugs":["essen-germany"],"enrichment":{"headline":"High-precision Radiosurgery Followed by Minimally Invasive Surgical Approach in Patients With High-prominen…","inPlainEnglish":"High-precision radiosurgery followed by minimally invasive surgical approach in patients with high-prominence uveal melanomas: modern radiation techniques and outcomes. Evaluation of outcome regarding multiparametric parameters and co-factors","whoItsFor":["Ages 18 Years to any","Functional Resectability,","Technical Resectability","high-prominent uveal melanoma"],"whoShouldSkip":["At least in part remaining eye function that can be saved"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 250 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.818Z"},{"nctId":"NCT07913503","title":"Inspiratory Muscle Training and Diaphragmatic Breathing in GAD","officialTitle":"Comparison of the Effectiveness of Inspiratory Muscle Training and Diaphragmatic Breathing Exercises in Individuals With Generalized Anxiety Disorder","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Saglik Bilimleri Universitesi","sponsorClass":"OTHER","summary":"This study will compare inspiratory muscle training and diaphragmatic breathing exercises in individuals with generalized anxiety disorder (GAD). It aims to investigate whether adding either breathing-based intervention to a combined exercise program improves anxiety symptoms and other health-related outcomes compared with adding progressive muscle relaxation.\n\nParticipants will be randomly assigned to one of three groups. All groups will receive the same combined exercise program. In addition, the first group will perform inspiratory muscle training, which involves breathing against resistance to strengthen the inspiratory muscles. The second group will perform diaphragmatic breathing exercises, which focus on using the diaphragm during breathing. The third group will receive Jacobson's progressive muscle relaxation technique, which involves systematically tensing and relaxing different muscle groups. All interventions will be delivered over eight weeks using a hybrid telerehabilitation approach combining face-to-face, synchronous online, and independent home-based sessions.\n\nThe study will evaluate anxiety symptoms, respiratory muscle strength, pulmonary function, functional exercise capacity, dyspnea, quality of life, depression symptoms, and heart rate variability. The findings may provide further evidence on the comparative effects of these interventions when added to a combined exercise program in individuals with GAD.","conditions":["Generalized Anxiety Disorder (GAD)"],"keywords":["Exercise","Progressive Muscle Relaxation","Inspiratory Muscle Training","Diaphragmatic Breathing","Telerehabilitation"],"interventions":[{"type":"DEVICE","name":"Inspiratory Muscle Training"},{"type":"BEHAVIORAL","name":"Diaphragmatic Breathing Exercises"},{"type":"BEHAVIORAL","name":"Progressive Muscle Relaxation"}],"enrollment":51,"startDate":"2026-09-17","completionDate":"2027-04-20","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nDiagnosis of generalized anxiety disorder (GAD) by a psychiatrist according to DSM-5 criteria.\n\nA score of 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale. Receiving clinically stable pharmacological treatment. Aged 18-65 years. No condition that prevents the use of a smartphone or access to the internet.\n\nExclusion Criteria:\n\nSevere pulmonary diseases (e.g., chronic obstructive pulmonary disease \\[COPD\\] or an asthma attack) or cardiac diseases (e.g., unstable angina).\n\nA primary psychiatric diagnosis other than generalized anxiety disorder. Orthopedic or neurological limitations that prevent exercise. Severe cardiovascular disease. Pregnancy. Substance use disorder. Recent abdominal or thoracic surgery.","locations":[{"facility":"Sultan 2.Abdulhamid Khan Educational and Research Hospital","city":"Istanbul","state":"Uskudar","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nergis Yılmaz","phone":"05318549782","email":"nergis-yilmaz39@hotmail.com"}],"primaryOutcomes":["Change in Anxiety Severity Measured by the GAD-7"],"hasResults":false,"conditionSlugs":["als","depression","anxiety"],"drugSlugs":[],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Inspiratory Muscle Training for Generalized Anxiety Disorder (GAD)","inPlainEnglish":"This study will compare inspiratory muscle training and diaphragmatic breathing exercises in individuals with generalized anxiety disorder (GAD). It aims to see if adding either breathing-based intervention to a combined exercise program improves anxiety symptoms and other health-related outcomes compared with adding progressive muscle relaxation.","whoItsFor":["Ages 18 Years to 65 Years","Diagnosis of generalized anxiety disorder (GAD) by a psychiatrist according to DSM-5 criteria","A score of 10 or higher on the Generalized Anxiety Disorder-7 (GAD-7) scale. Receiving clinically stable pharmacological treatment. Aged 18-65 years. No condition that prevents the use of a smartphone or access to the internet"],"whoShouldSkip":["Severe pulmonary diseases (e.g., chronic obstructive pulmonary disease \\[COPD\\] or an asthma attack) or cardiac diseases (e.g., unstable angina)","A primary psychiatric diagnosis other than generalized anxiety disorder. Orthopedic or neurological limitations that prevent exercise. Severe cardiovascular disease. Pregnancy. Substance use disorder. Recent abdominal or thoracic surgery"],"whatHappens":"If you join, the listed intervention(s) are Inspiratory Muscle Training, Diaphragmatic Breathing Exercises, or Progressive Muscle Relaxation. The registry lists allocation as randomized. This study will compare inspiratory muscle training and diaphragmatic breathing exercises in individuals with generalized anxiety disorder (GAD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 51 people at Istanbul. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.344Z"},{"nctId":"NCT07913919","title":"Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus Study","officialTitle":"Effect of Anifrolumab on Arterial Inflammation in Systemic Lupus Erythematosus (AISLE) Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Cambridge","sponsorClass":"OTHER","summary":"People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation. The aim of this study is to investigate the effects an interferon-targeting drug (anifrolumab) used for the treatment of active SLE on arterial inflammation. Arterial inflammation will be measured at baseline and after 4 months of treatment using Positron Emission Tomography (PET)/ Magnetic Resonance Imaging (MRI) with a radio-labelled tracer (68Ga-DOTATATE). Inflammation assessed by PET/MRI will also be compared with clinical disease activity, inflammatory blood markers and in patients with and without coronary artery disease on computed tomography coronary angiography (CTCA) and/or myocardial involvement on MRI.","conditions":["Systemic Lupus Erythematosus","Atherosclerosis Generalized"],"keywords":["cardio-rheumatology","Atherosclerosis","Lupus","Systemic Lupus Erythematosus","PET","MRI","DOTATATE","Anifrolumab","Interferon"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"68-Gallium Dotatate"},{"type":"DRUG","name":"Anifrolumab"}],"enrollment":15,"startDate":"2025-11-28","completionDate":"2027-09-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants 18 to 70 years of age\n2. Able to give written, informed consent and to lie flat for scanning\n3. Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE\n4. Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)\n5. Have ≥4 points on the clinical SLEDAI-2K disease activity score\n6. Stable standard of care SLE therapies for ≥4 weeks\n7. Prednisolone dosage ≤7.5 mg (or equivalent) daily\n8. Up to date on required vaccinations (e.g., pneumonia, varicella zoster, and influenza \\[inactivated/recombinant\\]) prior to study entry\n\nExclusion Criteria:\n\n1. Women of child-bearing potential not using adequate contraception\n2. Breastfeeding\n3. Already taking anifrolumab\n4. Allergy and/or contraindication to anifrolumab or excipients\n5. Anaphylaxis to any human gamma globulin therapy\n6. History of recurrent infections requiring hospitalisation and intravenous (IV) antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks)\n7. Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, confirmed by (a) HBsAg; or (b) HBcAb and HBV DNA detected above the lower limit of quantitation by reflex testing; or (c) HCV RNA\n8. Any severe case of herpes zoster (HZ) infection, including, but not limited to: (a) systemic HZ such as herpes encephalitis or ophthalmic herpes involving the retina at any time prior to signing the ICF; (b) recurrent cutaneous HZ defined as 2 or more episodes within 2 years prior to signing the ICF; (c) any HZ infection that has not completely resolved within 12 weeks prior to signing the ICF\n9. Any active cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n10. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to signing the ICF\n11. Any of the following infections: (a) clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc) within 8 weeks prior to signing the ICF (chronic nail infections are allowed); (b) any infection requiring hospitalization or treatment with IV anti-infectives not completed at least 4 weeks prior to signing the ICF; (c) any infection requiring oral anti-infectives (including antivirals) within 2 weeks prior to signing the ICF\n12. Any live or attenuated vaccine within 8 weeks prior to signing the informed consent form (ICF). Administration of killed or subunit vaccines is acceptable\n13. Immunocompromised (known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection, or a positive result for human immunodeficiency virus)\n14. History of active tuberculosis or latent tuberculosis in whom an adequate course of treatment could not be confirmed\n15. History of cancer (other than squamous or basal cell carcinoma of the skin/cervical cancer in situ treated with curative therapy more than 3 months prior to signing the ICF)\n16. Receiving other biological therapies or monoclonal antibodies\n17. Received rituximab or obinutuzumab within the past 24 weeks\n18. Received belimumab within the past 12 weeks\n\n18\\. Received cyclophosphamide in the past 6 months 19. Cardiovascular event ≤3 months 20. Contra-indication to MRI or CT scanning 21. Contrast allergy or contrast-nephropathy 22. Active nephritis (\\>1g protein/24hr or albumin to creatine ratio \\>100) 23. Active central nervous system lupus 24. Active myocarditis 25. Chronic kidney disease (eGFR \\<30 mL/min/1.73 m2) 26. Any condition that, in the opinion of the Investigator, would with impact patient safety, ability to complete imaging, or interfere with the interpretation of the study findings","locations":[{"facility":"Addenbrookes Hospital","city":"Cambridge","state":"Cambridgeshire","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Thomas AJ Bond, MBChB, BMedSci","phone":"+44 1223 331504","email":"thomas.bond4@nhs.net"}],"primaryOutcomes":["Comparison of coronary artery 68Ga-DOTATATE maximum tissue-to-blood ratio (TBRmax) after 16 weeks of anifrolumab compared to baseline"],"hasResults":false,"conditionSlugs":["als","lupus"],"drugSlugs":[],"locationSlugs":["cambridge-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: testing Anifrolumab for Systemic Lupus Erythematosus","inPlainEnglish":"People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation. The aim of this study is to investigate the effects an interferon-targeting drug (anifrolumab) used for the treatment of active SLE on arterial inflammation.","whoItsFor":["Ages 18 Years to 70 Years","Male or female participants 18 to 70 years of age","Fulfil American College of Rheumatology/European Alliance of Associations for Rheumatology 2019 classification criteria for SLE","Current antinuclear antibody positive (ANA-ELISA ≥1.0, ANA Hep2 positivity)","Have ≥4 points on the clinical SLEDAI-2K disease activity score","Stable standard of care SLE therapies for ≥4 weeks","Prednisolone dosage ≤7.5 mg (or equivalent) daily","Up to date on required vaccinations (e.g., pneumonia, varicella zoster, and influenza \\[inactivated/recombinant\\]) prior to study entry"],"whoShouldSkip":["Women of child-bearing potential not using adequate contraception","Already taking anifrolumab","Allergy and/or contraindication to anifrolumab or excipients","Anaphylaxis to any human gamma globulin therapy","History of recurrent infections requiring hospitalisation and intravenous (IV) antibiotics (e.g., 3 or more of the same type of infection over the previous 52 weeks)","Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection, confirmed by (a) HBsAg; or (b) HBcAb and HBV DNA detected above the lower limit of quantitation by reflex testing; or (c) HCV RNA","Any active cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF"],"whatHappens":"If you join, the listed intervention(s) are 68-Gallium Dotatate, or Anifrolumab. The registry lists allocation as na. People with systemic lupus erythematous (SLE) have an increased risk of premature atherosclerotic cardiovascular disease, which is believed to be caused by arterial inflammation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 15 people at Cambridge. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.277Z"},{"nctId":"NCT07914075","title":"Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers","officialTitle":"Kidney Shear Wave elasTography for REnal Stiffness in SyStemic Hypertension: a Prospective Pilot Study (K-STRESS Study)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Azienda Ospedaliera di Padova","sponsorClass":"OTHER","summary":"High blood pressure (hypertension) is a leading cause of kidney damage, but detecting early kidney changes remains challenging with currently available tools. This study investigates whether kidney stiffness, measured by a non-invasive ultrasound technique called shear wave elastography (SWE), differs across different subtypes of hypertension and healthy volunteers, and whether it may serve as an early marker of hypertension-related kidney damage. Adults with essential hypertension, renovascular hypertension, and primary aldosteronism, as well as healthy volunteers, undergo kidney ultrasound with SWE measurements combined with standard clinical, laboratory, and vascular assessments, with the aim of identifying the independent factors influencing kidney stiffness and evaluating its potential role as a simple, painless, and widely available imaging biomarker of kidney damage","conditions":["Arterial Hypertension, Chronic Kidney Disease","Primary Aldosteronism","Arterial Stenosis"],"keywords":["shear wave elastoghraphy","eco Doppler ultrasound","arterial hypertension","renal arterial stenosis","chronic kidney disease","primary aldosteronism"],"interventions":[],"enrollment":240,"startDate":"2026-08-11","completionDate":"2029-01-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults ≥18 y\n* Informed consent signed\n* diagnosis of essential or secondary hypertension or willingness to participate as healthy controls\n\nExclusion Criteria:\n\n* Known parenchymal renal disease other than hypertensive nephrosclerosis, including but not limited to glomerulonephritis, polycystic kidney disease, congenital nephropathy, and storage/infiltrative diseases (e.g. amyloidosis, Fabry disease), as classified according to KDIGO 2024 CKD guidelines (the presence of diabetes mellitus, cardiovascular disease, or peripheral artery disease does not constitute an exclusion criterion)\n* patients with urinary tract obstruction\n* renal transplant recipients\n* pregnant women\n* BMI \\>40\n* Kidney lesions such as renal stones/mass/Hydroureteronephrosis(HUN) or renal cyst in site where SWE will be performed (side specific, not patient specific exclusion criterion)","locations":[{"facility":"Azienda Ospedale Università di Padova","city":"Padova","state":"PD","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Mean renal cortical stiffness measured by shear wave elastography (SWE), expressed in kilopascals (kPa)"],"hasResults":false,"conditionSlugs":["chronic-kidney-disease","hypertension"],"drugSlugs":[],"locationSlugs":["padova-italy"],"enrichment":{"headline":"Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers","inPlainEnglish":"High blood pressure (hypertension) is a leading cause of kidney damage, but detecting early kidney changes remains challenging with currently available tools. This study investigates whether kidney stiffness, measured by a non-invasive ultrasound technique called shear wave elastography (SWE), differs across different subtypes of hypertension and healthy volunteers, and whether it may serve as an early marker of hypertension-related kidney damage.","whoItsFor":["Ages 18 Years to any","diagnosis of essential or secondary hypertension or willingness to participate as healthy controls"],"whoShouldSkip":["patients with urinary tract obstruction","renal transplant recipients","Kidney lesions such as renal stones/mass/Hydroureteronephrosis(HUN) or renal cyst in site where SWE will be performed (side specific, not patient specific exclusion criterion)"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 240 people at Padova. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.509Z"},{"nctId":"NCT07914088","title":"A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis","officialTitle":"A Phase II Double-Blind Study to Evaluate the Safety, Tolerability, and Efficacy of AR100DP1 in Subjects With Mild to Moderate Atopic Dermatitis","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Arjil Pharmaceuticals LLC","sponsorClass":"INDUSTRY","summary":"This study is composed of a two-arm, double-blind, randomized, placebo-controlled, Phase II study to evaluate the efficacy of AR100DP1 compared to placebo on AD lesion area(s) in subjects with mild to moderate AD.","conditions":["Dermatitis Atopic"],"keywords":[],"interventions":[{"type":"DRUG","name":"0.5% AR100DP1"},{"type":"OTHER","name":"Placebo"}],"enrollment":40,"startDate":"2026-10-21","completionDate":"2027-12-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Dated and signed informed consent\n2. Either gender, ≥ 18 years old (the legal age of consent majority is 18 years old in Taiwan)\n3. Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)\n4. Clinical diagnosis of AD with clinically consistent and stable disease status, defined as AD lesions with the Investigator's Global Assessment (IGA) score of 1(almost clear) to 3(moderate) for at least 4 weeks prior to Screening Visit, at the investigator's discretion\n5. Not expected to require regular AD maintenance therapy during the study period, at the investigator's discretion\n6. Have AD lesion area(s) with an IGA score of 1 to 3 at the Screening Visit and Day 1, with a maximum total treated area of 1,050 cm², as judged by the Investigator.\n7. Have a pruritus NRS score of ≥ 2 for both the average itch and the worst itch in the past 24 hours, as assessed at Screening Visit and Day 1 prior to randomization\n8. Subject of childbearing potential must agree to use abstinence to intercourse, or highly effective contraceptives from signing informed consent to 14 days after the last dose of study drug administration\n\nExclusion Criteria:\n\n1. Fluctuating or actively infected AD judged by the investigator\n2. Have any AD lesion with an IGA score of 4 at the Screening Visit or Day 1, as judged by the Investigator\n3. History of the following conditions, including irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases\n4. Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator\n5. Received systemic medication including immunosuppressant, phototherapy, or other therapy, which could affect AD within 4 weeks before Day 1\n6. Received systemic antihistamine within 5 half-lives (see Appendix 1 for half-lives of common antihistamine) prior to Day 1 (except for permitted background medication, Fexofenadine)\n7. Received systemic corticosteroid within 2 days or 5 half-lives, whichever is longer, prior to Day 1\n8. Received topical medication including corticosteroid, immunosuppressant, anti-histamine, phototherapy, calcineurin inhibitors, or other therapy for AD lesion area(s) within 1 week before Day 1\n9. Plan to receive immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine)\n10. Unwilling or unable to comply with the criteria in Life Style Guidelines (Section 5.3) during the study\n11. History of use of biologic therapy (including intravenous immunoglobulin) within 12 weeks or 5 half-lives (whichever is longer) prior to Day 1\n12. Received any other investigational drug within 4 weeks prior to Day 1\n13. Required or received systemic CYP3A4 inhibitors with strong potency within 1 week prior to Day 1, including but not limited to clarithromycin, itraconazole, nefazodone, and atazanavir, evaluated by the investigator\n14. Treatment for any type of cancer (except squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the skin, curatively treated with cryosurgery or surgical excision only) within 5 years before Day 1\n15. Had surgery within 4 weeks prior to Day 1, or plan to have surgery during the study.\n16. Known hypersensitivity to any of the components of the study drug\n17. Active clinically serious infection or any known history of immunodeficiency, including human immunodeficiency virus (HIV) infection\n18. Current uncontrolled asthma\n19. Any of the following serum test abnormalities:\n\n    * Total bilirubin \\> 1.5 × ULN\n    * AST or ALT \\> 3.0 × ULN\n    * Serum albumin \\< 2.5 g/dL\n    * Creatinine \\> 1.5 × ULN\n    * Any other ≥ Grade 2 (grading of NCI-CTCAE v6.0) laboratory abnormality at baseline (other than those listed above)\n20. With ongoing acute diseases or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association (NYHA) grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject\n21. Female subject who is lactating or has positive urine pregnancy test at Screening and Day 1\n22. Other conditions not suitable for participating in this study judged by the investigator\n23. Plan to donate blood, sperm, or eggs from Screening Visit until Final Visit","locations":[{"facility":"Taipei Medical University Hospital","city":"Taipei","state":"Taiwan","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null},{"facility":"Chang Gung Memorial Hospital-Linkou","city":"Taoyuan","state":"Taiwan","country":"Taiwan","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yeh B Wu","phone":"+886-3-573-3608","email":"ybw333@arjilbio.com"}],"primaryOutcomes":["The change of IGA to 0 or 1 at visit 4 after 14 days treatment"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["taipei-taiwan","taoyuan-taiwan"],"enrichment":{"headline":"Phase 2: testing 0.5% AR100DP1 for Dermatitis Atopic","inPlainEnglish":"This study is composed of a two-arm, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, Phase II study to measure the how well it works of AR100DP1 compared to dummy treatment (placebo) on AD lesion area(s) in subjects with mild to moderate AD.","whoItsFor":["Ages 18 Years to any","Either gender, ≥ 18 years old (the legal age of consent majority is 18 years old in Taiwan)","Confirmed clinical diagnosis of atopic dermatitis (based on the criteria of Hanifin and Rajka for AD)","Clinical diagnosis of AD with clinically consistent and stable disease status, defined as AD lesions with the Investigator's Global Assessment (IGA) score of 1(almost clear) to 3(moderate) for at least 4 weeks prior to Screening Visit, at the investigator's discretion","Not expected to require regular AD maintenance therapy during the study period, at the investigator's discretion","Have AD lesion area(s) with an IGA score of 1 to 3 at the Screening Visit and Day 1, with a maximum total treated area of 1,050 cm², as judged by the Investigator","Have a pruritus NRS score of ≥ 2 for both the average itch and the worst itch in the past 24 hours, as assessed at Screening Visit and Day 1 prior to randomization"],"whoShouldSkip":["Fluctuating or actively infected AD judged by the investigator","Have any AD lesion with an IGA score of 4 at the Screening Visit or Day 1, as judged by the Investigator","History of the following conditions, including irritant contact dermatitis, allergic contact dermatitis, skin infections (such as scabies), or other autoimmune skin diseases","Active or potentially recurrent dermatologic condition other than atopic dermatitis that may confound evaluation (e.g. fungal infection), judged by the investigator","Received systemic medication including immunosuppressant, phototherapy, or other therapy, which could affect AD within 4 weeks before Day 1","Received systemic antihistamine within 5 half-lives (see Appendix 1 for half-lives of common antihistamine) prior to Day 1 (except for permitted background medication, Fexofenadine)","Received systemic corticosteroid within 2 days or 5 half-lives, whichever is longer, prior to Day 1"],"whatHappens":"If you join, the listed intervention(s) are 0.5% AR100DP1, or Placebo. The registry lists allocation as randomized. This study is composed of a two-arm, neither you nor the study doctors know who gets the real treatment, randomly assigned, compared with a dummy treatment, Phase II study to measure the how well it works of AR100DP1 compared to dummy treatment (placebo) on AD lesion area(s) in subjects with mild to moderate AD.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 40 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.826Z"},{"nctId":"NCT07914478","title":"Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome","officialTitle":"Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Aziz Bhatti Shaheed Teaching Hospital","sponsorClass":"OTHER","summary":"This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. It was hypothesized that vitamin D supplementation would reduce symptom severity and increase blood vitamin D levels compared with placebo.\n\nThe study was a randomized, placebo-controlled trial at the Department of Pediatrics, Aziz Bhatti Shaheed Teaching Hospital, Gujrat, Pakistan. It included 60 children aged 6-14 years who met established diagnostic criteria for irritable bowel syndrome and had low blood vitamin D levels of 10-29 ng/mL. Children were randomly assigned to two groups of 30 participants each. One group received oral vitamin D3 drops containing 2,000 international units once daily for 12 weeks. The other group received matching placebo drops without vitamin D for the same period. Both groups received routine supportive care, including advice on hydration, regular meals, diet, and symptom management.\n\nFollow-up visits were scheduled at 4, 8, and 12 weeks to assess symptoms, treatment adherence, and possible side effects. The main outcome was the change in symptom severity from the start of treatment to 12 weeks, measured using a standardized symptom score. The secondary outcome was the change in blood vitamin D levels over the same period. Changes in both outcomes were compared between the two groups.","conditions":["Irritable Bowel Syndrome (IBS)","Vitamin D Deficiency"],"keywords":["Pediatric irritable bowel syndrome","Vitamin D supplementation","Cholecalciferol","Vitamin D insufficiency","Children"],"interventions":[{"type":"DRUG","name":"Vitamin D3"},{"type":"DRUG","name":"Placebo"}],"enrollment":48,"startDate":"2026-09-01","completionDate":"2027-03-30","sex":"ALL","minAge":"6 Years","maxAge":"14 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children aged 6 to 14 years of either gender.\n* Children diagnosed with irritable bowel syndrome according to Rome IV criteria as per operational definition.\n* Children belonging to any irritable bowel syndrome subtype, including IBS with constipation, IBS with diarrhea, mixed IBS, and unsubtyped IBS.\n* Children with serum 25-hydroxyvitamin D levels between 10 and 29 ng/mL, including vitamin D deficiency defined as 10-19 ng/mL and vitamin D insufficiency defined as 20-29 ng/mL.\n* Children with symptoms present for at least 2 months prior to enrollment.\n* Children who are able to take oral vitamin D supplementation and attend follow-up visits.\n* Children whose parents or legal guardians provide written informed consent, with assent from the child where appropriate.\n\nExclusion Criteria:\n\n* Children with vitamin D deficiency or normal/sufficient vitamin D level.\n* Children with evidence of organic gastrointestinal disease, including inflammatory bowel disease, celiac disease, peptic ulcer disease, gastrointestinal tuberculosis, chronic liver disease, pancreatic disease, intestinal obstruction, Hirschsprung disease, or gastrointestinal malignancy.\n* Children having alarm features suggestive of organic pathology, including: unintentional weight loss, growth failure or short stature, persistent fever, gastrointestinal bleeding, including hematemesis, melena, or blood in stool, chronic severe diarrhea, unexplained anemia, organomegaly\n* Children with chronic systemic illness that may affect vitamin D metabolism or gastrointestinal symptoms, including chronic kidney disease, nephrotic syndrome, hyperparathyroidism, malabsorption syndrome, metabolic bone disease, or endocrine disorders.\n* Children receiving vitamin D supplements, calcium supplements, multivitamins containing vitamin D, corticosteroids, anticonvulsants, rifampicin, or other drugs affecting vitamin D metabolism within the last 8 weeks.\n* Children with acute gastrointestinal infection at the time of assessment.\n* Children with severe neurodevelopmental, psychiatric, or communication disorders making reliable symptom assessment difficult.\n* Children with a history of major abdominal surgery likely to affect bowel function.","locations":[{"facility":"Aziz Bhatti Shaheed Teaching Hospital","city":"Gujrat","state":"Punjab Province","country":"Pakistan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Imaan Tahir","phone":"+92 308 1850511","email":"imaantahir105@gmail.com"}],"primaryOutcomes":["Change in Irritable Bowel Syndrome Symptom Severity Score"],"hasResults":false,"conditionSlugs":["als","ibs"],"drugSlugs":[],"locationSlugs":["gujrat-pakistan"],"enrichment":{"headline":"Not a traditional drug phase: testing Vitamin D3 for Irritable Bowel Syndrome (IBS)","inPlainEnglish":"This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits. It was hypothesized that vitamin D supplementation would reduce symptom severity and increase blood vitamin D levels compared with dummy treatment (placebo).","whoItsFor":["Ages 6 Years to 14 Years","Children aged 6 to 14 years of either gender","Children diagnosed with irritable bowel syndrome according to Rome IV criteria as per operational definition","Children belonging to any irritable bowel syndrome subtype, including IBS with constipation, IBS with diarrhea, mixed IBS, and unsubtyped IBS","Children with serum 25-hydroxyvitamin D levels between 10 and 29 ng/mL, including vitamin D deficiency defined as 10-19 ng/mL and vitamin D insufficiency defined as 20-29 ng/mL","Children with symptoms present for at least 2 months prior to enrollment","Children who are able to take oral vitamin D supplementation and attend follow-up visits"],"whoShouldSkip":["Children with vitamin D deficiency or normal/sufficient vitamin D level","Children with chronic systemic illness that may affect vitamin D metabolism or gastrointestinal symptoms, including chronic kidney disease, nephrotic syndrome, hyperparathyroidism, malabsorption syndrome, metabolic bone disease, or endocrine disorders","Children receiving vitamin D supplements, calcium supplements, multivitamins containing vitamin D, corticosteroids, anticonvulsants, rifampicin, or other drugs affecting vitamin D metabolism within the last 8 weeks","Children with acute gastrointestinal infection at the time of assessment","Children with severe neurodevelopmental, psychiatric, or communication disorders making reliable symptom assessment difficult","Children with a history of major abdominal surgery likely to affect bowel function"],"whatHappens":"If you join, the listed intervention(s) are Vitamin D3, or Placebo. The registry lists allocation as randomized. This study was designed to determine whether vitamin D supplementation improved symptoms in children with irritable bowel syndrome, a condition associated with repeated abdominal pain and changes in bowel habits.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 48 people at Gujrat. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.431Z"},{"nctId":"NCT07914556","title":"Phase 1 Study of 6MW5311 in Adults With Relapsed or Refractory Blood Cancers","officialTitle":"A Phase 1, Safety, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy Study of 6MW5311 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients, in Chronic Myelomonocytic Leukemia (CMML) Patients and Multiple Myeloma (MM) Patients","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Mabwell (Shanghai) Bioscience Co., Ltd.","sponsorClass":"INDUSTRY","summary":"To assess safety and tolerability at increasing dose levels of 6MW5311 in successive cohorts of participants with MM, AML and CMML in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) or the recommended expansion dose (RED).","conditions":["AML","Multiple Myeloma","CMML"],"keywords":["LILRB4","CD3","TCE"],"interventions":[{"type":"BIOLOGICAL","name":"6MW5311"}],"enrollment":122,"startDate":"2026-09-16","completionDate":"2029-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18 years or older at the time of signing the informed consent form; male or female.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for the dose-escalation part, or 0 to 2 for the dose-expansion part.\n3. Life expectancy greater than 3 months.\n4. Multiple myeloma (MM): histologically and/or cytologically confirmed MM per International Myeloma Working Group (IMWG) 2016 criteria, with at least 3 prior lines of MM therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.\n\n   * Chronic myelomonocytic leukemia (CMML): morphologically confirmed by bone marrow examination per World Health Organization (WHO) 2016 classification, with relapsed disease or failure of prior therapy.\n   * Acute myeloid leukemia (AML; dose-expansion part only): morphologically confirmed acute myelomonocytic leukemia or acute monocytic leukemia per WHO 2016 classification, meeting the protocol definition of relapsed or refractory AML.\n5. MM only: measurable disease at screening.\n6. Adequate hematologic function at screening:\n7. Able to understand and comply with the protocol requirements, willing to participate in the clinical study, and able to provide written informed consent.\n\nExclusion Criteria:\n\n* 1\\. AML and CMML only: any other anticancer therapy within 2 weeks before the first dose of study drug.\n\nMM only: prior anticancer therapy within the following intervals before the first dose of study drug:\n\n* small-molecule targeted therapy within 4 weeks or 5 half-lives, whichever is shorter;\n* antibody therapy within 3 weeks;\n* cytotoxic chemotherapy, proteasome inhibitor therapy, or traditional Chinese medicine (including Chinese patent medicine) with an anticancer indication within 2 weeks;\n* immunomodulatory agent within 1 week;\n* chimeric antigen receptor T-cell (CAR-T) therapy within 3 months;\n* radiotherapy within 1 week. 2. Receipt of any other investigational drug within 4 weeks before the first dose of study drug.\n\n  3\\. Prior allogeneic stem cell transplant; or autologous stem cell transplant within 3 months before the first dose of study drug.\n\n  4\\. Planned stem cell transplant during the study. 5. Prior treatment with a LILRB4-targeted therapy.","locations":[{"facility":"Shanghai Jiao Tong University School of Medicine, Ruijin Hospital","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jiangjiang Lv","phone":"+86-021-58585793","email":"jiangjiang.lv@mabwell.com"}],"primaryOutcomes":["Number of participants with dose-limiting toxicities (DLTs)","Number of participants with treatment-emergent adverse events (TEAEs)"],"hasResults":false,"conditionSlugs":["multiple-myeloma"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 1: testing 6MW5311 for AML","inPlainEnglish":"To assess whether it is safe and how hard side effects are to live with at increasing dose levels of 6MW5311 in successive cohorts of participants with MM, AML and CMML in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) or the recommended expansion dose (RED).","whoItsFor":["Ages 18 Years to any","Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for the dose-escalation part, or 0 to 2 for the dose-expansion part","Life expectancy greater than 3 months","Multiple myeloma (MM): histologically and/or cytologically confirmed MM per International Myeloma Working Group (IMWG) 2016 criteria, with at least 3 prior lines of MM therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody","Chronic myelomonocytic leukemia (CMML): morphologically confirmed by bone marrow examination per World Health Organization (WHO) 2016 classification, with relapsed disease or failure of prior therapy","Acute myeloid leukemia (AML; dose-expansion part only): morphologically confirmed acute myelomonocytic leukemia or acute monocytic leukemia per WHO 2016 classification, meeting the protocol definition of relapsed or refractory AML","MM only: measurable disease at screening","Adequate hematologic function at screening:"],"whoShouldSkip":["1\\. AML and CMML only: any other anticancer therapy within 2 weeks before the first dose of study drug","MM only: prior anticancer therapy within the following intervals before the first dose of study drug:","small-molecule targeted therapy within 4 weeks or 5 half-lives, whichever is shorter;","antibody therapy within 3 weeks;","cytotoxic chemotherapy, proteasome inhibitor therapy, or traditional Chinese medicine (including Chinese patent medicine) with an anticancer indication within 2 weeks;","immunomodulatory agent within 1 week;","chimeric antigen receptor T-cell (CAR-T) therapy within 3 months;"],"whatHappens":"If you join, the listed intervention(s) are 6MW5311. The registry lists allocation as randomized. To assess whether it is safe and how hard side effects are to live with at increasing dose levels of 6MW5311 in successive cohorts of participants with MM, AML and CMML in order to estimate the maximum tolerated dose (MTD) and select the recommended Phase 2 dose (RP2D) or the recommended expansion dose (RED).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 122 people at Shanghai. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.516Z"},{"nctId":"NCT07914634","title":"Virtual Reality Assisted Trauma Focused CBT","officialTitle":"Exploring the Feasibility of Virtual Reality-Assisted Trauma-Focused Cognitive Behavioural Therapy for PTSD: A Mixed Methods Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Queen's University, Belfast","sponsorClass":"OTHER","summary":"Virtual Reality (VR) is becoming an increasingly important tool in mental healthcare, offering new ways to enhance patient treatment. Over the past decade, there's been growing interest in using VR therapies because they create immersive, controlled environments tailored to individual therapeutic needs. In a safe and controlled, therapeutic setting, these environments can help patients work through difficult emotions and experiences. However, despite its potential, the widespread adoption of VR in routine mental healthcare has been slow due to the high costs of the necessary technology, making it less accessible for many patients and therapists.\n\nVR is particularly valuable in mental health therapy because it can evoke strong cognitive, emotional, and physical responses, much like traditional therapeutic techniques that use imagery or visualisation. Research has shown that VR can offer unique benefits, such as real-time monitoring of a patient's responses and creating customised exposure therapies that safely mimic real-world scenarios. These features can be incredibly effective in treating conditions like Post Traumatic Stress Disorder (PTSD), anxiety, and phobias.\n\nThis study aims to overcome the barriers to VR adoption by developing a more affordable approach to creating virtual environments that can be used in everyday mental healthcare. Collaborating with a software company called ProPeer Solutions, the project has created a process called \"VR Photoscan.\" This method allows for the creation of virtual environments at a lower cost, making it more accessible to clinics and therapists. The ultimate goal is to integrate VR into standard mental health treatments, making this innovative technology available to more people who could benefit from it, specifically within routine psychological therapy services for adults with PTSD.","conditions":["PTSD - Post Traumatic Stress Disorder"],"keywords":["Virtual reality","VR","VR Photoscan","PTSD","TF-CBT"],"interventions":[{"type":"DEVICE","name":"VR Photoscan"},{"type":"BEHAVIORAL","name":"Trauma-Focused Cognitive Behavioural Therapy (TF-CBT)"}],"enrollment":40,"startDate":"2026-10-05","completionDate":"2028-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults who self-report the experience of type 1 trauma (NI related)\n* PTSD symptoms as identified via PCL-5 \\> 31\n* Ability to give informed consent -Suitable and willingness to engage in TF- CBT\n\nExclusion Criteria:\n\n* History of seizures, seizure disorder, or epilepsy\n* History of bipolar disorder, psychosis, or schizophrenia\n* Younger than 18 years old\n* Previously engaged in TF-CBT within the PTS in past 12 months\n* Actively suicidal or undertaken suicidal action in past 3 months\\*\n* Severe substance dependency \\*Participants who have been actively suicidal or have undertaken suicidal actions within the past three months will be excluded from the study. However, given the complexities of mental health and its treatment, the presence of passive suicidal ideation (e.g., thoughts of not wanting to live, without intent or plan) does not automatically lead to exclusion, provided that the participant is assessed as not being at immediate risk. Clinical judgement will be used during the screening process, and ongoing risk will be monitored throughout the study. A distress protocol is in place for the intervention","locations":[{"facility":"Whiteabbey Hospital - Psychological Therapies Service","city":"Newtownabbey","state":"County Antrim","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paul Best, PhD, MsC","phone":"02890973256","email":"p.best@qub.ac.uk"}],"primaryOutcomes":["PCL-5"],"hasResults":false,"conditionSlugs":["ptsd"],"drugSlugs":[],"locationSlugs":["newtownabbey-united-kingdom"],"enrichment":{"headline":"Not a traditional drug phase: VR Photoscan for PTSD - Post Traumatic Stress Disorder","inPlainEnglish":"Virtual Reality (VR) is becoming an increasingly important tool in mental healthcare, offering new ways to enhance patient treatment. Over the past decade, there's been growing interest in using VR therapies because they create immersive, controlled environments tailored to individual therapeutic needs.","whoItsFor":["Ages 18 Years to any","Adults who self-report the experience of type 1 trauma (NI related)","PTSD symptoms as identified via PCL-5 \\> 31"],"whoShouldSkip":["History of seizures, seizure disorder, or epilepsy","History of bipolar disorder, psychosis, or schizophrenia","Younger than 18 years old","Previously engaged in TF-CBT within the PTS in past 12 months","Actively suicidal or undertaken suicidal action in past 3 months\\*"],"whatHappens":"If you join, the listed intervention(s) are VR Photoscan, or Trauma-Focused Cognitive Behavioural Therapy (TF-CBT). The registry lists allocation as randomized. Virtual Reality (VR) is becoming an increasingly important tool in mental healthcare, offering new ways to enhance patient treatment.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Newtownabbey. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.409Z"},{"nctId":"NCT07914764","title":"68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis","officialTitle":"Clinical Application Research of 68Ga-labeled Cholecystokinin Receptor (CCK2R) Targeted Molecular Probes in Early Tumor Diagnosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Nanjing First Hospital, Nanjing Medical University","sponsorClass":"OTHER","summary":"Evaluate the safety of the novel radioactive nuclide-labeled cholecystokinin receptor (CCK2R) targeted molecular probe, 68Ga-YQ-CC05, in clinical application, and verify its effectiveness in tumor diagnosis.","conditions":["Medullary Thyroid Carcinoma","Small Cell Lung Cancer ( SCLC )","Gastric Adenocarcinoma"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Intravenous injection of 68Ga-YQ-CC05 for PET-CT examination"}],"enrollment":20,"startDate":"2026-08-01","completionDate":"2026-10-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Volunteer to participate in the trial, with the patient or their legal guardian signing the informed consent form;\n* Volunteers are not limited by gender, and the age range is from 18 to 75 years old, inclusive;\n* Other imaging examination methods (CT, MRI, etc.) reveal tumor occupying lesions;\n* Tumor patients who can obtain the final pathological results.\n* Kidney: GFR \\> 50 ml/min, ERPF \\> 280 ml/min, platelet count (PLT) \\> 75,000/μL, white blood cell (WBC) \\> 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the normal value.\n\nExclusion Criteria:\n\n* Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to CCK2R), allergic constitution, or current allergic diseases;\n* Those who are currently participating in other clinical drug studies, or have previously participated in any clinical drug studies (excluding vitamins and minerals);\n* Other uncontrollable clinical issues (such as HIV, hepatitis C virus infection, active hepatitis B, or other severe chronic infections, as well as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases);\n* Red blood cells (RBC) count less than 4×10\\^12, white blood cells (WBC) count less than 3×10\\^9, hemoglobin level less than 110g/L, and platelet count (PLT) less than 75,000×10\\^9;\n* Obvious abnormalities in liver and kidney function, with GFR less than 50 ml/min;\n* Tumor burden greater than 50%, or significant spinal cord compression;\n* Expected survival duration less than half a year; chemotherapy within 6 months;\n* Having severe acute concomitant diseases or severe treatment-resistant mental disorders;\n* Pregnant and lactating women (where pregnancy is defined as a positive urine pregnancy test result);\n* Patients who are physically unfit for radiological examinations;\n* Other situations where the researcher deems it inappropriate for the participant to participate in the trial.","locations":[{"facility":"Nanjing First Hospital","city":"Nanjing","state":"Jiangsu","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Feng Wang","phone":"+8602552271491","email":"fengwangcn@hotmail.com"}],"primaryOutcomes":["SUVmax of lesion uptake value"],"hasResults":false,"conditionSlugs":["lung-cancer"],"drugSlugs":[],"locationSlugs":["nanjing-china"],"enrichment":{"headline":"Not a traditional drug phase: Intravenous injection of 68Ga-YQ-CC05 for PET-CT examination for Medullary Thyroid Carcinoma","inPlainEnglish":"Measure the safety of the novel radioactive nuclide-labeled cholecystokinin receptor (CCK2R) targeted molecular probe, 68Ga-YQ-CC05, in clinical application, and verify its effectiveness in tumor diagnosis.","whoItsFor":["Ages 18 Years to 75 Years","Volunteers are not limited by gender, and the age range is from 18 to 75 years old, inclusive;","Other imaging examination methods (CT, MRI, etc.) reveal tumor occupying lesions;","Tumor patients who can obtain the final pathological results","Kidney: GFR \\> 50 ml/min, ERPF \\> 280 ml/min, platelet count (PLT) \\> 75,000/μL, white blood cell (WBC) \\> 3,000/μL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the normal value"],"whoShouldSkip":["Individuals with a history of allergy to similar drugs (drugs with similar chemical or biological components to CCK2R), allergic constitution, or current allergic diseases;","Those who are currently participating in other clinical drug studies, or have previously participated in any clinical drug studies (excluding vitamins and minerals);","Other uncontrollable clinical issues (such as HIV, hepatitis C virus infection, active hepatitis B, or other severe chronic infections, as well as severe mental, neurological, cardiovascular, respiratory, and other systemic diseases);","Red blood cells (RBC) count less than 4×10\\^12, white blood cells (WBC) count less than 3×10\\^9, hemoglobin level less than 110g/L, and platelet count (PLT) less than 75,000×10\\^9;","Obvious abnormalities in liver and kidney function, with GFR less than 50 ml/min;","Tumor burden greater than 50%, or significant spinal cord compression;","Expected survival duration less than half a year; chemotherapy within 6 months;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 20 people at Nanjing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.982Z"},{"nctId":"NCT07914907","title":"GenAI-Assisted Rheumatoid Arthritis Bone Erosion Risk Assessment and DMARD Selection","officialTitle":"Prospective Evaluation of Generative AI-Augmented Clinical Decision-Making for Rheumatoid Arthritis Bone Erosion Risk (RABER) Assessment and DMARD Selection in Routine Care","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","sponsorClass":"OTHER","summary":"Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint damage and bone erosion. Accurate assessment of RA bone erosion risk (RABER) and appropriate disease-modifying antirheumatic drug (DMARD) selection are critical to preventing irreversible disability.\n\nRecent advances in generative artificial intelligence (GenAI), particularly large language models (LLMs), enable integration of heterogeneous clinical data and may improve clinical decision-making. However, there is limited real-world evidence (RWE) evaluating whether GenAI can meaningfully augment physician decision-making in routine care.\n\nThis prospective, single-arm, nonrandomized interventional study evaluates the feasibility and impact of GenAI-assisted clinical decision support on physician assessment of rheumatoid arthritis bone erosion risk and disease-modifying antirheumatic drug selection in routine inpatient care. Treating physicians document their initial risk assessments and treatment decisions before reviewing patient-specific GenAI reports and subsequently record their assessments and decisions after reviewing the reports. The study evaluates changes in physician clinical decision-making within a learning health system framework. Final treatment decisions remain under the responsibility of the treating physicians. The study does not evaluate long-term patient clinical outcomes.","conditions":["Rheumatoid Arthritis"],"keywords":["RA bone erosion risk","GenAI prediction","LLMs","DMARD","real-world data","real-world evidence","learning health system unit","GenAI-assisted clinical decision support"],"interventions":[{"type":"OTHER","name":"GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection"}],"enrollment":100,"startDate":"2026-03-01","completionDate":"2026-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Newly diagnosed RA patients meeting American College of Rheumatology / European League Against Rheumatism 2010 classification criteria\n* Consecutive inpatients admitted during study period\n\nExclusion Criteria:\n\n* Patients subsequently determined not to have RA\n* Incomplete clinical data preventing risk or treatment assessment","locations":[{"facility":"Guang'anmen Hospital of China Academy of Chinese Medical Sciences","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Quan Jiang, MD","phone":"010-88001942","email":"doctorjq@126.com"}],"primaryOutcomes":["Percentage of Participants With a Change in Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Level After GenAI-Assisted Decision Support","Cohen's Kappa Agreement Between Physician-Assessed Rheumatoid Arthritis Bone Erosion Risk Levels and the Reference Standard Before and After GenAI-Assisted Decision Support"],"hasResults":false,"conditionSlugs":["rheumatoid-arthritis"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection for Rheumatoid Arthritis","inPlainEnglish":"Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint damage and bone erosion. Accurate assessment of RA bone erosion risk (RABER) and appropriate disease-modifying antirheumatic drug (DMARD) selection are critical to preventing irreversible disability.","whoItsFor":["Ages 18 Years to any","Newly diagnosed RA patients meeting American College of Rheumatology / European League Against Rheumatism 2010 classification criteria","Consecutive inpatients admitted during study period"],"whoShouldSkip":["Patients subsequently determined not to have RA","Incomplete clinical data preventing risk or treatment assessment"],"whatHappens":"If you join, the listed intervention(s) are GenAI-Assisted Clinical Decision Support for RABER Assessment and DMARD Selection. The registry lists allocation as na. Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by progressive joint damage and bone erosion.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.955Z"},{"nctId":"NCT07914933","title":"The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy","officialTitle":"The Effect of Levosimendan on Pulmonary Artery Pressure and Right Ventricular Function in the Perioperative Period in Patients With CTEPH After Pulmonary Thromboendarterectomy: a Single-center Pilot Prospective Randomized Placebo-controlled Double-blind Clinical Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Meshalkin Research Institute of Pathology of Circulation","sponsorClass":"NETWORK","summary":"A single-center pilot prospective randomized placebo-controlled double-blind clinical trial.\n\nStudy objective - to investigate the efficacy and safety of levosimendan in patients in the perioperative period following pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension (CTEPH).\n\nResearch Objectives:\n\n1. To assess the impact of levosimendan administration on pulmonary artery pressure during the perioperative period in patients who have undergone pulmonary endarterectomy for CTEPH.\n2. To evaluate the effect of levosimendan administration on right ventricular function parameters during the perioperative period in patients after pulmonary endarterectomy for CTEPH.\n3. To determine the influence of levosimendan on the need for inotropic and vasopressor support (VIS) during the perioperative period in patients following pulmonary endarterectomy for CTEPH.\n4. To examine the effect of levosimendan on the clinical course and complications during the postoperative period in patients after pulmonary endarterectomy for CTEPH.\n5. To evaluate the cardioprotective effect of levosimendan in patients following pulmonary endarterectomy for CTEPH.\n6. To assess the impact of levosimendan on in-hospital mortality in patients after pulmonary endarterectomy for CTEPH.","conditions":["LEVOSIMENDAN","PULMONARY THROMBOENDARTERECTOMY","Chronic Thromboembolic Pulmonary Hypertension (CTEPH)","Pulmonary Hypertension"],"keywords":["LEVOSIMENDAN","Pulmonary Thromboendarterectomy","Pulmonary Artery Pressure","Right Ventricular Function","Perioperative Period"],"interventions":[{"type":"DRUG","name":"Infusion of levosimendan"},{"type":"DRUG","name":"Placebo infusion \"Soluvit\""}],"enrollment":50,"startDate":"2025-04-29","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntary signed informed consent to participate in the study\n* Scheduled for pulmonary thromboendarterectomy surgery\n* Aged ≥18 years\n\nExclusion Criteria :\n\n* Patient refusal\n* Language barrier preventing understanding of the study\n* Severe renal failture (creatinine clearance \\<30 mL/min)\n* Severe hepatic insufficiency (Child-Pugh score \\>9 points)\n* Participation in other clinical trials\n* History of allergic reaction to levosimendan, Soluvit, or any of their components\n* Use of levosimendan within 30 days prior to screening\n\nDiscontinuation Criteria (or Withdrawal Criteria):\n\n* Need for extracorporeal membrane oxygenation (ECMO) support during the perioperative period\n* Pulmonary hemorrhage during the perioperative period","locations":[{"facility":"Meshalkin Research Institute of Pathology of Circulation","city":"Novosibirsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gleb Moroz, PhD","phone":"+79833177148","email":"g_moroz@meshalkin.ru"}],"primaryOutcomes":["Mean pulmonary artery pressure (mPAP)"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["novosibirsk-russia"],"enrichment":{"headline":"Not a traditional drug phase: testing Infusion of levosimendan for LEVOSIMENDAN","inPlainEnglish":"A single-center pilot prospective randomly assigned compared with a dummy treatment neither you nor the study doctors know who gets the real treatment clinical trial. Study objective - to investigate the how well it works and safety of levosimendan in patients in the perioperative period following pulmonary endarterectomy for chronic thromboembolic pulmonary hypertension (CTEPH).","whoItsFor":["Ages 18 Years to any","Scheduled for pulmonary thromboendarterectomy surgery"],"whoShouldSkip":["Language barrier preventing understanding of the study","Severe renal failture (creatinine clearance \\<30 mL/min)","Severe hepatic insufficiency (Child-Pugh score \\>9 points)","Participation in other clinical trials","History of allergic reaction to levosimendan, Soluvit, or any of their components","Use of levosimendan within 30 days prior to screening","Discontinuation Criteria (or Withdrawal Criteria):"],"whatHappens":"If you join, the listed intervention(s) are Infusion of levosimendan, or Placebo infusion \"Soluvit\". The registry lists allocation as randomized. A single-center pilot prospective randomly assigned compared with a dummy treatment neither you nor the study doctors know who gets the real treatment clinical trial.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Novosibirsk. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.046Z"},{"nctId":"NCT07915102","title":"CAR-T Therapy: Safety, Efficacy, and Immune-Escape Mechanisms","officialTitle":"Biological Observational Study for Monitoring Patients Receiving Chimeric Antigen Receptor T-cell (CAR-T) Therapies, Identifying Predictive Factors of Efficacy and Safety, and Understanding Immune-escape Mechanisms to Optimize Existing Platforms","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ciceri Fabio","sponsorClass":"OTHER","summary":"The study is a biological, drug-related, non-interventional observational study with both retrospective and prospective components.\n\nNo experimental diagnostic procedures, investigational medicinal products, or medical devices will be used, and samples will be collected as part of routine clinical practice.","conditions":["CAR-T Cell Therapy","Bispecific Antibodies"],"keywords":[],"interventions":[],"enrollment":225,"startDate":"2023-02-02","completionDate":"2030-06-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nTo achieve the objectives of this study, biological samples will be obtained from patients aged 18 years or older who meet at least one of the following inclusion criteria:\n\n* Patients eligible for CAR-T-cell therapy who have signed at least an initial informed consent for evaluation for this treatment at our center.\n* Patients who have previously signed the informed consent for the Hematological Malignancies Biobank (Biobanca Neoplasie Ematologiche) and for whom stored biological samples are available.\n* Patients eligible for bispecific antibody therapy who have signed at least an initial informed consent for evaluation for this treatment at our center.\n\nExclusion Criteria:\n\n* Participation in clinical trial protocols that explicitly prohibit participation in biological observational studies.","locations":[{"facility":"IRCCS San Raffaele Hospital","city":"Milan","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Overall Response Rate (ORR)","Incidence of Cytokine Release Syndrome (CRS)","Incidence of Neurotoxicity","Progression-Free Survival (PFS)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["car-t"],"locationSlugs":["milan-italy"],"enrichment":{"headline":"CAR-T Therapy: Safety, Efficacy, and Immune-Escape Mechanisms","inPlainEnglish":"The study is a biological, drug-related, non-treatment watch-and-measure (no experimental treatment required) study with both retrospective and prospective components. No experimental diagnostic procedures, investigational medicinal products, or medical devices will be used, and samples will be collected as part of routine clinical practice.","whoItsFor":["Ages 18 Years to any","To achieve the objectives of this study, biological samples will be obtained from patients aged 18 years or older who meet at least one of the following who can join:"],"whoShouldSkip":["Participation in clinical trial protocols that explicitly prohibit participation in biological watch-and-measure (no experimental treatment required) studies"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 225 people at Milan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.408Z"},{"nctId":"NCT07915609","title":"A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-WEEKLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY WITH OR WITHOUT TYPE 2 DIABETES (VESPER-OA 2)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity with and without type 2 diabetes. The study will last 52 weeks and compare the effects of berobenatide compared to placebo on knee pain, physical function, and body weight. Study activities will include blood tests, knee pain assessment, physical function questionnaires and body measurements.","conditions":["Obesity","Overweight and/or Obesity","Knee Osteoarthritis","Diabetes Melliuts, Type 2"],"keywords":["Knee Pain, Osteoarthritis, Weight Management","Knee Osteoarthritis","Overweight","Obesity","Type 2 diabetes","Diabetes","GLP1","GLP1 RA","WOMAC","Knee pain","Osteoarthritis","Weight Management","VESPER"],"interventions":[{"type":"DRUG","name":"Berobenatide"},{"type":"DRUG","name":"Placebo"}],"enrollment":756,"startDate":"2026-10-26","completionDate":"2028-08-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults 18 years of age or older, or the minimum age of consent according to local regulations.\n* Body mass index of at least 27 kg/m² at Screening.\n* Currently meets American College of Rheumatology (ACR) Criteria for knee OA.\n* Pain due to knee OA.\n* Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.\n* Willingness to complete the required analgesic washout.\n* History of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nHbA1c value at Screening of:\n\n1. \\<6.5% (48 mmol/mol) for participants without T2D\n2. ≥6.5% (48 mmol/mol) and \\<10.0% (86 mmol/mol) for participants with T2D\n\nExclusion Criteria\n\n* Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.\n* For participants with T2D at Screening only:\n\n  • Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention\n* Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.\n* Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.\n* Significant active or unstable psychiatric disorder.\n* Condition or knee disorder that could confound assessment of target-knee pain\n* Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.\n* Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.\n* Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.\n* Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.","locations":[{"facility":"Central Alabama Research","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Noble Clinical Research, LLC","city":"Tucson","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"International Research Associates LLC","city":"Miami","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Carolina Research Center","city":"Shelby","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity","osteoarthritis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","tucson-arizona","miami-florida","shelby-north-carolina"],"enrichment":{"headline":"Phase 3: testing Berobenatide for Obesity","inPlainEnglish":"The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity with and without type 2 diabetes. The study will last 52 weeks and compare the effects of berobenatide compared to dummy treatment (placebo) on knee pain, physical function, and body weight.","whoItsFor":["Ages 18 Years to any","Adults 18 years of age or older, or the minimum age of consent according to local regulations","Body mass index of at least 27 kg/m² at Screening","Currently meets American College of Rheumatology (ACR) Criteria for knee OA","Pain due to knee OA","Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3","Willingness to complete the required analgesic washout","History of at least 1 self-reported unsuccessful dietary effort to lose body weight"],"whoShouldSkip":["Self-reported body weight increase or decrease greater than 5% within 90 days before Screening","For participants with T2D at Screening only:","Diabetic maculopathy, proliferative diabetic retinopathy, or severe non-proliferative diabetic retinopathy requiring immediate intervention","Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease","Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2","Significant active or unstable psychiatric disorder","Condition or knee disorder that could confound assessment of target-knee pain"],"whatHappens":"If you join, the listed intervention(s) are Berobenatide, or Placebo. The registry lists allocation as randomized. The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity with and without type 2 diabetes.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 756 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.516Z"},{"nctId":"NCT07915882","title":"Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions","officialTitle":"Feasibility of a Remote Collaborative Care-Facilitated Contingency Management-Exercise Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Michael Incze","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate the feasibility and preliminary effectiveness of increasing control over stimulant use and physical health through incentivized rehabilitation (INSPIRE). INSPIRE is a 12-week remotely-delivered collaborative care intervention for rural patients with Methamphetamine-Associated Heart Failure (Me-HF) or Methamphetamine-Associated Pulmonary Arterial Hypertension (Me-PAH) featuring smartphone-based contingency management incentivizing participation in remote synchronous rehabilitation.","conditions":["Methamphetamine-Associated Heart Failure","Methamphetamine-Associated Pulmonary Arterial Hypertension"],"keywords":["Methamphetamine","Stimulant Use Disorder","Collaborative Care","Contingency Management","Substance Use Disorders","Cardiac Rehabilitation","Telehealth","Mobile App"],"interventions":[{"type":"BEHAVIORAL","name":"Increasing control over stimulant use and physical health through incentivized rehabilitation"},{"type":"OTHER","name":"Usual Care"}],"enrollment":45,"startDate":"2026-10-13","completionDate":"2028-10-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Active methamphetamine use determined by positive urine drug testing within the past 3 months and/or self-reported current use\n* Current diagnosis of chronic heart failure or pulmonary hypertension documented in the electronic health record\n* Possession of a smartphone\n* Able to participate in virtual exercise rehabilitation\n\nExclusion Criteria:\n\n* Currently incarcerated\n* Unable to interact with smartphone app and/or virtual health coaching sessions in English\n* Unstable arrhythmia, defined as any known arrhythmia that is associated with hemodynamic effects like syncope, hypotension, or decompensated heart failure\n* Decompensated chronic heart failure or pulmonary hypertension\n* NYHA class IV symptoms\n* Myocardial infarction within the past 3 months, percutaneous coronary intervention within the past 2 weeks, coronary artery bypass graft within the past 3 months, or implantable cardiac defibrillator/cardiac resynchronization therapy/pacemaker implantation within the last 6 weeks\n* Unstable angina, uncontrolled hypertension, acute myocarditis/pericarditis, intracardiac thrombus\n* Severe symptomatic aortic stenosis","locations":[{"facility":"University of Utah Health","city":"Salt Lake City","state":"Utah","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Michael A Incze, MD","phone":"801-581-2000","email":"Michael.Incze@hsc.utah.edu"}],"primaryOutcomes":["Change in metabolic equivalents (METs)","Change in self-reported substance use"],"hasResults":false,"conditionSlugs":["heart-failure","hypertension"],"drugSlugs":[],"locationSlugs":["salt-lake-city-utah"],"enrichment":{"headline":"Not a traditional drug phase: Increasing control over stimulant use and physical health through incentivized rehabilitation for Methamphetamine-Associated Heart Failure","inPlainEnglish":"This study wants to measure the feasibility and preliminary effectiveness of increasing control over stimulant use and physical health through incentivized rehabilitation (INSPIRE). INSPIRE is a 12-week remotely-delivered collaborative care intervention for rural patients with Methamphetamine-Associated Heart Failure (Me-HF) or Methamphetamine-Associated Pulmonary Arterial Hypertension (Me-PAH) featuring smartphone-based contingency management incentivizing participation in remote synchronous rehabilitation.","whoItsFor":["Ages 18 Years to any","Active methamphetamine use determined by positive urine drug testing within the past 3 months and/or self-reported current use","Current diagnosis of chronic heart failure or pulmonary hypertension documented in the electronic health record","Possession of a smartphone","Able to participate in virtual exercise rehabilitation"],"whoShouldSkip":["Currently incarcerated","Unable to interact with smartphone app and/or virtual health coaching sessions in English","Unstable arrhythmia, defined as any known arrhythmia that is associated with hemodynamic effects like syncope, hypotension, or decompensated heart failure","Decompensated chronic heart failure or pulmonary hypertension","NYHA class IV symptoms","Unstable angina, uncontrolled hypertension, acute myocarditis/pericarditis, intracardiac thrombus","Severe symptomatic aortic stenosis"],"whatHappens":"If you join, the listed intervention(s) are Increasing control over stimulant use and physical health through incentivized rehabilitation, or Usual Care. The registry lists allocation as randomized. This study wants to measure the feasibility and preliminary effectiveness of increasing control over stimulant use and physical health through incentivized rehabilitation (INSPIRE).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 45 people at Salt Lake City. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.445Z"},{"nctId":"NCT07916480","title":"Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis","officialTitle":"A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Arcutis Biotherapeutics, Inc.","sponsorClass":"INDUSTRY","summary":"This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.\n\nFollowing completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.","conditions":["Atopic Dermatitis","Atopic Dermatitis (AD)","Atopic Dermatitis (Eczema)"],"keywords":["Atopic Dermatitis","Eczema","Roflumilast","Roflumilast Cream","Phosphodiesterase 4 Inhibitor","PDE4 Inhibitor","Moderate Atopic Dermatitis","Severe Atopic Dermatitis","Pruritus","Inflammatory Skin Disease","Topical Therapy","Dermatology"],"interventions":[{"type":"DRUG","name":"Roflumilast Cream 0.3%"},{"type":"DRUG","name":"Vehicle Cream"}],"enrollment":415,"startDate":"2026-10-30","completionDate":"2028-04-27","sex":"ALL","minAge":"6 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged 6 years and older.\n2. Clinical diagnosis of moderate to severe atopic dermatitis.\n3. vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.\n4. EASI score ≥5 at baseline.\n5. Atopic dermatitis involvement of ≥3% and ≤30% body surface area.\n6. Able and willing to comply with study procedures.\n7. Participant or parent/legal guardian able to provide informed consent/assent.\n\nExclusion Criteria:\n\n1. Uncontrolled medical conditions that could interfere with study participation.\n2. Skin disorders that may confound study assessments.\n3. Active infection requiring systemic treatment.\n4. Known hypersensitivity to roflumilast or formulation components.\n5. Use of prohibited medications within protocol-defined washout periods.\n6. Pregnant or breastfeeding participants.\n7. Participation in another interventional clinical trial within the protocol-defined timeframe.\n8. Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.","locations":[{"facility":"Arcutis Site 324","city":"Birmingham","state":"Alabama","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcutis Site 337","city":"Bryant","state":"Arkansas","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcutis Site 321","city":"Miami Lakes","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Arcutis Site 320","city":"Chicago","state":"Illinois","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Arcutis Medical Information","phone":"1-844-692-6729","email":"medinfo@arcutis.com"}],"primaryOutcomes":["Achievement of vIGA-AD Success at Week 4"],"hasResults":false,"conditionSlugs":["atopic-dermatitis"],"drugSlugs":[],"locationSlugs":["birmingham-alabama","bryant-arkansas","miami-lakes-florida","chicago-illinois"],"enrichment":{"headline":"Phase 3: testing Roflumilast Cream 0.3% for Atopic Dermatitis","inPlainEnglish":"This Phase 3 study is designed to measure the how well it works and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 you would be randomly assigned in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week neither you nor the study doctors know who gets the real treatment, vehicle-controlled treatment period.","whoItsFor":["Ages 6 Years to any","Male or female participants aged 6 years and older","Clinical diagnosis of moderate to severe atopic dermatitis","vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline","EASI score ≥5 at baseline","Atopic dermatitis involvement of ≥3% and ≤30% body surface area"],"whoShouldSkip":["Uncontrolled medical conditions that could interfere with study participation","Skin disorders that may confound study assessments","Active infection requiring systemic treatment","Known hypersensitivity to roflumilast or formulation components","Use of prohibited medications within protocol-defined washout periods","Pregnant or breastfeeding participants","Participation in another treatment clinical trial within the protocol-defined timeframe"],"whatHappens":"If you join, the listed intervention(s) are Roflumilast Cream 0.3%, or Vehicle Cream. The registry lists allocation as randomized. This Phase 3 study is designed to measure the how well it works and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 415 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.820Z"},{"nctId":"NCT07916688","title":"Lactic Acid Bacteria in Functional Diarrheal Disorders","officialTitle":"Efficacy of Lactic Acid Bacteria in Managing Diarrhea-Associated Functional Gastrointestinal Disorders: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"TRIPLE","sponsor":"Szeged University","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD). These conditions can cause frequent loose stools, abdominal discomfort, and a lower quality of life.\n\nThe main questions this study aims to answer are:\n\n* Does the probiotic improve quality of life compared with a placebo (a look-alike capsule that contains no active bacteria)?\n* Does the probiotic help participants have more normal stool consistency and fewer bowel movements?\n* Is the probiotic safe and well tolerated in people with IBS-D or FD?\n\nResearchers will compare the probiotic supplement with a placebo to see whether the probiotic improves symptoms and quality of life.\n\nParticipants will:\n\n* Take either the probiotic or placebo capsule once daily for 3 months.\n* Switch to the other study treatment for an additional 3 months.\n* Complete quality-of-life questionnaires at the start of the study, after 3 months, and after 6 months.\n* Record the number of bowel movements each day throughout the study.\n* Record stool consistency each day using the Bristol Stool Form Scale.\n* Record daily pain during bowel movements using a Visual Analog Scale (VAS).\n* Report any medications they take and any health problems that occur during the study.\n\nThe study will follow each participant for 6 months. Researchers hope the results will help determine whether this probiotic is a useful treatment option for people living with IBS-D or functional diarrhea.","conditions":["IBS-D (Diarrhea-predominant)","IBS (Irritable Bowel Syndrome)","Functional Diarrhea"],"keywords":["IBS","IBS-D","FD","probiotic","supplement"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"LL1500"},{"type":"OTHER","name":"Placebo Capsule"}],"enrollment":100,"startDate":"2026-11","completionDate":"2028-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Have diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) diagnosed using Rome V criteria.\n* Have had symptoms for at least 6 months.\n* Have no warning signs that suggest another digestive disease.\n* Have been taking the same treatment for IBS-D, FD, and other medical conditions for at least 1 month before joining the study.\n* Are willing and able to provide written informed consent and follow study procedures.\n\nExclusion Criteria:\n\n* Took antibiotics or probiotic products within the past 4 weeks.\n* Had abdominal surgery in the past, except appendix removal (appendectomy).\n* Have another type of irritable bowel syndrome or another functional digestive disorder.\n* Have a known digestive disease that may explain their symptoms.\n* Plan to start a new medication or change the dose of an existing medication during the study (except antispasmodic medications).\n* Are unable or unwilling to complete study questionnaires and daily symptom records.","locations":[{"facility":"University of Szeged","city":"Szeged","state":"","country":"Hungary","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tamás Molnár","phone":"+36-62-545-189","email":"molnar.tamas@med.u-szeged.hu"}],"primaryOutcomes":["Irritable Bowel Syndrome Quality of Life (IBS-QOL) Total Score at 3 Months"],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["szeged-hungary"],"enrichment":{"headline":"Not a traditional drug phase: LL1500 for IBS-D (Diarrhea-predominant)","inPlainEnglish":"The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD). These conditions can cause frequent loose stools, abdominal discomfort, and a lower quality of life.","whoItsFor":["Ages 18 Years to any","Adults aged 18 years or older","Have diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD) diagnosed using Rome V criteria","Have had symptoms for at least 6 months","Have no warning signs that suggest another digestive disease","Have been taking the same treatment for IBS-D, FD, and other medical conditions for at least 1 month before joining the study"],"whoShouldSkip":["Took antibiotics or probiotic products within the past 4 weeks","Had abdominal surgery in the past, except appendix removal (appendectomy)","Have another type of irritable bowel syndrome or another functional digestive disorder","Have a known digestive disease that may explain their symptoms","Plan to start a new medication or change the dose of an existing medication during the study (except antispasmodic medications)","Are unable or unwilling to complete study questionnaires and daily symptom records"],"whatHappens":"If you join, the listed intervention(s) are LL1500, or Placebo Capsule. The registry lists allocation as randomized. The goal of this clinical trial is to learn whether a probiotic supplement can improve symptoms and quality of life in adults with diarrhea-predominant irritable bowel syndrome (IBS-D) or functional diarrhea (FD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Szeged. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.429Z"},{"nctId":"NCT07916727","title":"Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study","officialTitle":"Specific and Novel Approaches to Care of Inflammatory Bowel Disease During Pregnancy: the PREGO Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Austin Health","sponsorClass":"OTHER_GOV","summary":"IBD pregnancy requires multidisciplinary management, but access to this may be difficult for some, resulting in variation in care which may in turn impair quality of healthcare delivery. We need to devise innovative ways to deliver care to overcome these barriers. The PREGO study will interrogate the value of multidisciplinary care in IBD pregnancy, and test a new virtual-based way of improving access to care.","conditions":["Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)","Pregnancy"],"keywords":[],"interventions":[{"type":"OTHER","name":"Dedicated IBD pregnancy care"}],"enrollment":50,"startDate":"2026-04-15","completionDate":"2027-12","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Biologically female adult patients (aged 18 years or older) with a diagnosis of inflammatory bowel disease (IBD) receiving care for their IBD during pregnancy\n\nExclusion Criteria:\n\n* Non-pregnant inflammatory bowel disease patients\n* Non-consenting patients\n* Age \\<18\n* Pregnant patients with inflammatory bowel disease receiving dedicated IBD pregnancy care at an alternative tertiary institution","locations":[{"facility":"Royal Hobart Hospital","city":"Hobart","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Austin Health","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Eastern Health","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Health","city":"Melbourne","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Peninsula Health","city":"Melbourne","state":"","country":"Australia","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Royal Prince Alfred Hospital","city":"Sydney","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null},{"facility":"St Vincent's Hospital Darlinghurst","city":"Sydney","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Simone Chin","phone":"+61406022754","email":"simone.chin@austin.org.au"},{"name":"Peter De Cruz","phone":"+61 03 9496 5000","email":"peter.decruz@austin.org.au"}],"primaryOutcomes":["Decisional conflict"],"hasResults":false,"conditionSlugs":["crohns-disease","ulcerative-colitis"],"drugSlugs":[],"locationSlugs":["hobart-australia","melbourne-australia","sydney-australia"],"enrichment":{"headline":"Not a traditional drug phase: Dedicated IBD pregnancy care for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)","inPlainEnglish":"IBD pregnancy requires multidisciplinary management, but access to this may be difficult for some, resulting in variation in care which may in turn impair quality of healthcare delivery. We need to devise innovative ways to deliver care to overcome these barriers.","whoItsFor":["Ages 18 Years to any","Women only","Biologically female adult patients (aged 18 years or older) with a diagnosis of inflammatory bowel disease (IBD) receiving care for their IBD during pregnancy"],"whoShouldSkip":["Non-pregnant inflammatory bowel disease patients","Non-consenting patients","Pregnant patients with inflammatory bowel disease receiving dedicated IBD pregnancy care at an alternative tertiary institution"],"whatHappens":"If you join, the listed intervention(s) are Dedicated IBD pregnancy care. The registry lists allocation as randomized. IBD pregnancy requires multidisciplinary management, but access to this may be difficult for some, resulting in variation in care which may in turn impair quality of healthcare delivery.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.892Z"},{"nctId":"NCT07916909","title":"The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study","officialTitle":"The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Women's Hospital School Of Medicine Zhejiang University","sponsorClass":"OTHER","summary":"Introduction : Androgens play a vital role in the female reproductive system, influencing ovarian follicular development, oocyte quality, and ovarian responsiveness to controlled ovarian stimulation. The main circulating androgens include dehydroepiandrosterone sulfate (DHEA-S), dehydroepiandrosterone (DHEA), androstenedione (AD), testosterone (T), and dihydrotestosterone (DHT). Studies have shown that androgens promote early follicular growth by regulating follicle-stimulating hormone (FSH) receptor expression and the intrafollicular microenvironment; however, excessive levels may interfere with follicular maturation and ovulation, leading to ovarian dysfunction. Total testosterone (TT) represents the sum of bound and free circulating testosterone. The majority of circulating testosterone is tightly bound to sex hormone-binding globulin (SHBG) or loosely bound to albumin (ALB), α-globulins, and corticosteroid-binding globulin, with only 1-4% existing as free testosterone (FT). Only free testosterone can enter cells and exert biological effects. Because SHBG concentrations are readily influenced by sex, age, body weight, metabolic syndrome, SHBG gene polymorphisms, and certain medications, whereas FT is unaffected by SHBG, FT is considered an ideal marker for assessing bioactive testosterone status. Free testosterone, as the most biologically active androgen form, is closely correlated with ovarian response, particularly in patients with polycystic ovary syndrome (PCOS).\n\nMass spectrometry （LC-MS/MS）is widely recognized as a highly accurate method for determining androgen profiles. However, due to various factors such as cost, large-scale studies using mass spectrometry to measure androgen profiles have not yet been conducted, and there is even a lack of research on the diagnostic performance of mass spectrometry-derived androgen profiles for polycystic ovary syndrome (PCOS).\n\nThe aim of this study is to evaluate the diagnostic performance (AUC, sensitivity, and specificity) of LC-MS/MS-measured androgen profiles in a multicenter real-world cohort for PCOS diagnosis. We will compare the diagnostic value of DHEA-S, DHEA, AD, T, DHT, and FT, and develop a multi-marker combined diagnostic model using machine learning to optimize the diagnostic efficacy for PCOS.\n\nThe primary research question is: Can LC-MS/MS-measured androgen profiles improve the diagnostic accuracy for PCOS?\n\nBy recruiting an appropriate number of participants and measuring the above serum biomarkers, we will statistically analyze the diagnostic performance of LC-MS/MS-determined androgen profiles, especially free testosterone (FT), in PCOS.","conditions":["Polycystic Ovary Syndrome (PCOS)"],"keywords":[],"interventions":[{"type":"OTHER","name":"No Intervention: Observational Cohort"},{"type":"DIAGNOSTIC_TEST","name":"No Intervention: Observational Cohort"},{"type":"DIAGNOSTIC_TEST","name":"No Intervention: Observational Cohort"}],"enrollment":1500,"startDate":"2026-07-01","completionDate":"2028-06-30","sex":"FEMALE","minAge":"18 Years","maxAge":"40 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nPCOS group:Women who meet the Rotterdam diagnostic criteria (at least two of the following three features after excluding other endocrine disorders: oligo-ovulation/anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology on ultrasound).\n\nControl group: Age-matched healthy women or women attending the clinic for routine gynecological check-ups who have regular menstrual cycles and show no clinical or biochemical signs of hyperandrogenism, and no polycystic ovarian morphology on ultrasound.\n\nExclusion Criteria:\n\nOvarian resistance syndrome, complete androgen insensitivity syndrome, functional hypothalamic amenorrhea, adrenocortical hyperplasia, and other similar conditions; Use of medications that affect hormone secretion within 3 months prior to enrollment; Thyroid dysfunction, hyperprolactinemia, and other endocrine disorders.-","locations":[{"facility":"Women's Hospital, School of Medicine, Zhejiang University","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiaoyu Tu","phone":"+86 13868092157","email":"tuxiaoyu789@zju.edu.cn"}],"primaryOutcomes":["Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS)","Area Under the ROC Curve (AUC) of LC-MS/MS-derived Androgen Profiles for the Diagnosis of Polycystic Ovary Syndrome (PCOS)"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Not a traditional drug phase: No Intervention: Observational Cohort for Polycystic Ovary Syndrome (PCOS)","inPlainEnglish":"Introduction : Androgens play a vital role in the female reproductive system, influencing ovarian follicular development, oocyte quality, and ovarian responsiveness to controlled ovarian stimulation. The main circulating androgens include dehydroepiandrosterone sulfate (DHEA-S), dehydroepiandrosterone (DHEA), androstenedione (AD), testosterone (T), and dihydrotestosterone (DHT).","whoItsFor":["Ages 18 Years to 40 Years","Women only","PCOS group:Women who meet the Rotterdam diagnostic criteria (at least two of the following three features after excluding other endocrine disorders: oligo-ovulation/anovulation, clinical and/or biochemical hyperandrogenism, and polycystic ovarian morphology on ultrasound)","Control group: Age-matched healthy women or women attending the clinic for routine gynecological check-ups who have regular menstrual cycles and show no clinical or biochemical signs of hyperandrogenism, and no polycystic ovarian morphology on ultrasound"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 1,500 people at Hangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.785Z"},{"nctId":"NCT07917403","title":"Study NRPT Feasibility in Knee Osteoarthritis","officialTitle":"A Prospective, Single-Arm, Open-Label Pilot Study to Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults With Knee Osteoarthritis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis","conditions":["Knee Osteoarthristis"],"keywords":[],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"NRPT"}],"enrollment":30,"startDate":"2026-12","completionDate":"2027-12","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form.\n2. Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation.\n3. Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex.\n4. Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined from a standing knee radiograph obtained within the prior 12 months or at Screening.\n5. Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening.\n6. No changes in OA-directed therapy (including analgesics, NSAIDs, topical therapies, or non-pharmacologic regimens) in the 3 months prior to Screening.\n7. Agreement to refrain from vitamin B3-containing supplements (nicotinic acid, nicotinamide, nicotinamide riboside) and any multivitamin containing these ingredients for at least 14 days prior to Baseline and throughout the duration of the study.\n8. Ability to take oral capsule medication and willingness to adhere to the prescribed NRPT regimen.\n9. Agreement to adhere to lifestyle considerations specified in Section 5.3 throughout the study.\n\nExclusion Criteria:\n\n1. Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement).\n2. Severe radiographic knee disease (KL grade 4) in the index knee.\n3. Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees).\n4. Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal arthropathy of the index knee).\n5. Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other polyphenol-containing supplements (including resveratrol, curcumin) within the 3 months prior to Screening.\n6. Self-reported substantive change in physical activity level (initiation of a new exercise program or cessation of regular activity) within the 3 months prior to Screening.\n7. Pregnancy, lactation, or planning pregnancy during the study period. Women of childbearing potential must have a negative serum or urine pregnancy test at Screening.\n8. Severe or uncontrolled comorbid conditions that, in the opinion of the investigator, would compromise participant safety or interpretability of study data, including but not limited to: uncontrolled diabetes mellitus (HbA1c \\>9.0% or requiring recent insulin initiation); active cardiovascular disease (myocardial infarction, unstable angina, decompensated heart failure, or stroke within 6 months); severe chronic kidney disease (eGFR \\<30 mL/min/1.73 m²); active liver disease or AST/ALT \\>2.5× the upper limit of normal; active malignancy (other than non-melanoma skin cancer) within 5 years; or active substance use disorder.\n9. Known allergy or hypersensitivity to nicotinamide riboside, pterostilbene, resveratrol, or any excipient of Basis®.\n10. Concurrent participation in another interventional clinical trial or use of an investigational agent within 30 days prior to Screening.\n11. Any other condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the protocol or with the safety or scientific integrity of the study.","locations":[{"facility":"UCSD, La Jolla, California","city":"San Diego","state":"California","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Monica Guma, MD, Phd","phone":"8588226523","email":"mguma@ucsd.edu"}],"primaryOutcomes":["Adherence to NRPT Supplement","Participant Retention Rate","Participants recruitment rate"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["san-diego-california"],"enrichment":{"headline":"Not a traditional drug phase: NRPT for Knee Osteoarthristis","inPlainEnglish":"To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis","whoItsFor":["Ages 18 Years to 80 Years","Stated willingness to comply with all study procedures and availability for the planned 14-week duration of participation","Adults aged 18 to 80 years (inclusive) at the time of consent, of any sex","Unilateral symptomatic radiographic KOA defined as Kellgren-Lawrence (KL) grade 2 or 3 in the tibiofemoral joint of the index knee, as determined from a standing knee radiograph obtained within the prior 12 months or at Screening","Knee pain in the index knee with a Visual Analogue Scale (VAS) score of 20-80 (on a 0-100 scale) over the prior 7 days at Screening","No changes in OA-directed therapy (including analgesics, NSAIDs, topical therapies, or non-pharmacologic regimens) in the 3 months prior to Screening","Agreement to refrain from vitamin B3-containing supplements (nicotinic acid, nicotinamide, nicotinamide riboside) and any multivitamin containing these ingredients for at least 14 days prior to Baseline and throughout the duration of the study","Ability to take oral capsule medication and willingness to adhere to the prescribed NRPT regimen"],"whoShouldSkip":["Prior surgical intervention on the index knee (including arthroscopy, ligament reconstruction, osteotomy, or joint replacement)","Severe radiographic knee disease (KL grade 4) in the index knee","Bilateral symptomatic radiographic KOA (i.e., KL grade ≥2 with symptomatic pain in both knees)","Diagnosis of inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or crystal arthropathy of the index knee)","Use of systemic corticosteroids, intra-articular corticosteroid or hyaluronic acid injection in the index knee, chondroitin, glucosamine, or other polyphenol-containing supplements (including resveratrol, curcumin) within the 3 months prior to Screening","Self-reported substantive change in physical activity level (initiation of a new exercise program or cessation of regular activity) within the 3 months prior to Screening","Pregnancy, lactation, or planning pregnancy during the study period. Women of childbearing potential must have a negative serum or urine pregnancy test at Screening"],"whatHappens":"If you join, the listed intervention(s) are NRPT. The registry lists allocation as na. To Evaluate Feasibility and Exploratory Clinical and Biomarker Signals of NRPT in Adults with Knee Osteoarthritis","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at San Diego. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.516Z"},{"nctId":"NCT07917442","title":"Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome","officialTitle":"Evaluation of the Prevalence, and Immunological Characteristics of Small Fiber Neuropathy in Patients With Primary Sjögren's Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Centre Hospitalier Universitaire, Amiens","sponsorClass":"OTHER","summary":"The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases. Among peripheral nervous system complication, SFN appears to be prevalent. However the association between pSS and SFN has been scarcely evaluated. There are not many relevant studies using similar methodology to evaluate pSS patients for small fiber dysfunction. Furthermore, autoimmune mechanisms are thought to play a key role in SFN pathogenesis in pSS and the association between SFN and specific immunological profiles has been poorly studied. So the aim of this study is to evaluate the prevalence of SFN in pSS patients by using the Sudoscan which is a fast and non- invasive tool. The Sudoscan could offer an accessible alternative for early SFN detection, improving patient management. The secondary purpose is to analyze systemic and immunological profiles, as well as disease's activity and quality of life of patients with pSS-related SFN.","conditions":["Sjögren's Syndrome","Small Fiber Neuropathy","Autonomic Dysfunction","Autoantibodies","Non-invasive Diagnosis"],"keywords":["Sjögren's syndrome","small fiber neuropathy","Sudoscan","autonomic dysfunction","autoantibodies","non-invasive diagnosis"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Sudoscan testing"}],"enrollment":100,"startDate":"2026-03-31","completionDate":"2027-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016\n* Body Mass Index between 18 and 35 kg/m²\n\nExclusion Criteria:\n\n* Secondary or unconfirmed Sjögren's syndrome,\n* Age \\< 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion,\n* Other conditions that may cause small fiber neuropathy,\n* type 2 diabetes,\n* excessive alcohol consumption,\n* sarcoidosis\n* obesity","locations":[{"facility":"CHU Amiens","city":"Amiens","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Valéry SALLE, MD","phone":"33+3 22 66 82 30","email":"salle.valery@chu-amiens.fr"}],"primaryOutcomes":["prevalence of SFN in patients with pSS"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["amiens-france"],"enrichment":{"headline":"Not a traditional drug phase: Sudoscan testing for Sjögren's Syndrome","inPlainEnglish":"The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN. Peripheral nervous system involvement account for 15% of pSS cases.","whoItsFor":["Ages 18 Years to any","Primary Sjögren's syndrome confirmed according to ACR/EULAR criteria 2016","Body Mass Index between 18 and 35 kg/m²"],"whoShouldSkip":["Secondary or unconfirmed Sjögren's syndrome,","Age \\< 18 years, Use of medications that could interfere with Sudoscan results and which could not be discontinued before inclusion,","Other conditions that may cause small fiber neuropathy,","excessive alcohol consumption,"],"whatHappens":"If you join, the listed intervention(s) are Sudoscan testing. The registry lists allocation as na. The investigators propose to conduct a prospective study evaluating the prevalence of SNN in pSS patients and to find clinical characteristics and specific immunological profiles in pSS patients with SFN.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Amiens. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.954Z"},{"nctId":"NCT07918209","title":"Remote Rehabilitation in Patients With HFpEF (PATRON-HF)","officialTitle":"A Multicenter, Randomized Research Experiment to Compare the Standard Care Model to a Rehabilitation Strategy Based on Remotely Monitored, Regular Training Using a Bicycle Ergometer in Patients With Heart Failure With Preserved Ejection Fraction (PATRON-HF)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"American Heart of Poland","sponsorClass":"OTHER","summary":"Heart failure with preserved ejection fraction (HFpEF) is characterized by typical symptoms of heart failure, structural and functional cardiac abnormalities, and elevated serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), despite preserved left ventricular ejection fraction. Typical symptoms of HFpEF include reduced exercise tolerance, exertional dyspnea, paroxysmal nocturnal dyspnea, and orthopnea.\n\nIt is estimated that approximately 35 million people worldwide suffer from HFpEF, including approximately 3 million patients in the United States. The exact number of patients with HFpEF remains unknown; however, the prevalence of the disease is increasing. Risk factors for HFpEF include obesity, arterial hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, and advanced age. Patients with HFpEF are hospitalized an average of 1.4 times per year, and the annual mortality rate is approximately 15%. To date, the most effective approach to the management of HFpEF has been the control of comorbidities, including diabetes mellitus, arterial hypertension, coronary artery disease, and obesity.\n\nRemote rehabilitation (RR) has already become an established component of modern cardiology. It is widely used in developed countries, and its popularity continues to increase. Its main advantages include reduced costs for both patients and healthcare payers compared with traditional, center-based rehabilitation. In addition, for patients living far from rehabilitation centers or those with limited access to transportation, remote rehabilitation provides a solution to improve access to care.\n\nThe efficacy and safety of remote rehabilitation have been demonstrated in cardiac patients with coronary artery disease and in patients with heart failure with reduced ejection fraction (HFrEF). However, to date, the safety and efficacy of remote rehabilitation in patients with HFpEF have not been sufficiently investigated. Therefore, the aim of the proposed study is to assess the safety and efficacy of remote rehabilitation in patients with HFpEF.","conditions":["Heart Failure With Preserved Ejection Fraction"],"keywords":["Heart Failure with Preserved Ejection Fraction","telerehabilitation"],"interventions":[{"type":"OTHER","name":"Telerehabilitation"}],"enrollment":110,"startDate":"2025-09-30","completionDate":"2029-11-30","sex":"ALL","minAge":"40 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Presence of at least one of the following symptoms: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, prolonged recovery time after exercise.\n2. Presence of at least one of the following findings on physical examination: elevated jugular venous pressure, hepatojugular reflux, audible third heart sound (S3), laterally displaced apical impulse.\n3. Presence of at least one of the following findings on transthoracic echocardiography: enlarged left atrium and/or left ventricle, E/e' ≥13, e' \\<9 cm/s.\n4. NT-proBNP \\>250 pg/mL or \\>600 pg/mL in patients with atrial fibrillation.\n5. Left ventricular ejection fraction (LVEF) ≥50%.\n6. Age \\>40 years.\n7. Ability to perform exercise on a bicycle ergometer with ECG monitoring.\n8. No contraindications to coronary angiography.\n\nExclusion Criteria:\n\n1. History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days.\n2. Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries.\n3. Left ventricular ejection fraction (LVEF) \\<50%.\n4. Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology.\n5. Constrictive pericarditis.\n6. Atrial fibrillation or atrial flutter with a heart rate \\>110 bpm at the first visit.\n7. Blood pressure \\>180/110 mmHg.\n8. Acute decompensated heart failure.\n9. Chronic pulmonary disease requiring home oxygen therapy and/or oral corticosteroid therapy.\n10. Pulmonary hypertension.\n11. Liver transaminase levels \\>3 times the upper limit of the local reference range.\n12. Chronic kidney disease with eGFR \\<20 mL/min/1.73 m².\n13. Hemoglobin \\<9 mg/dL.\n14. Active malignancy or suspected malignancy.\n15. Alcohol use disorder or illicit drug use.\n16. Allergy to the adhesive or material used in the electrodes required for telemonitoring.\n17. In the investigator's opinion, the patient is unable to participate in the clinical trial.","locations":[{"facility":"Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów","city":"Chrzanów","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Telcor Medical Center Scanmed","city":"Katowice","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null},{"facility":"Polish-American Heart Clinics X Department of Invasive Cardiology, Electrophysiology and Electrostimulation in Tychy","city":"Tychy","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Natalia Pydyn, PhD","phone":"+48 667 132 233","email":"natalia.pydyn@ahop.pl"}],"primaryOutcomes":["Efficacy","Number of participants with treatment-related adverse events as assessed by CTCAE v4.0"],"hasResults":false,"conditionSlugs":["obesity","heart-failure","atrial-fibrillation","hypertension"],"drugSlugs":[],"locationSlugs":["chrzan-w-poland","katowice-poland","tychy-poland"],"enrichment":{"headline":"Not a traditional drug phase: Telerehabilitation for Heart Failure With Preserved Ejection Fraction","inPlainEnglish":"Heart failure with preserved ejection fraction (HFpEF) is characterized by typical symptoms of heart failure, structural and functional cardiac abnormalities, and elevated serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), despite preserved left ventricular ejection fraction. Typical symptoms of HFpEF include reduced exercise tolerance, exertional dyspnea, paroxysmal nocturnal dyspnea, and orthopnea.","whoItsFor":["Ages 40 Years to any","Presence of at least one of the following symptoms: dyspnea, orthopnea, paroxysmal nocturnal dyspnea, reduced exercise tolerance, fatigue, prolonged recovery time after exercise","Presence of at least one of the following findings on physical examination: elevated jugular venous pressure, hepatojugular reflux, audible third heart sound (S3), laterally displaced apical impulse","Presence of at least one of the following findings on transthoracic echocardiography: enlarged left atrium and/or left ventricle, E/e' ≥13, e' \\<9 cm/s","NT-proBNP \\>250 pg/mL or \\>600 pg/mL in patients with atrial fibrillation","Left ventricular ejection fraction (LVEF) ≥50%","Ability to perform exercise on a bicycle ergometer with ECG monitoring","No contraindications to coronary angiography"],"whoShouldSkip":["History of myocardial infarction, stroke, transient ischemic attack, or another major cardiovascular event within the previous 60 days","Microvascular angina, defined as exertional anginal chest pain in the absence of stenosis in the epicardial coronary arteries","Left ventricular ejection fraction (LVEF) \\<50%","Diagnosed cardiomyopathy, including infiltrative, storage, hypertrophic, or cardiomyopathy caused by a known reversible etiology","Constrictive pericarditis","Atrial fibrillation or atrial flutter with a heart rate \\>110 bpm at the first visit","Blood pressure \\>180/110 mmHg"],"whatHappens":"If you join, the listed intervention(s) are Telerehabilitation. The registry lists allocation as randomized. Heart failure with preserved ejection fraction (HFpEF) is characterized by typical symptoms of heart failure, structural and functional cardiac abnormalities, and elevated serum levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP), despite preserved left ventricular ejection fraction.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 110 people at 3 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.433Z"},{"nctId":"NCT07918222","title":"Sequential Treatment Approaches for Treatment-Resistant Schizophrenia","officialTitle":"Sequential Treatment Approaches for Treatment-Resistant Schizophrenia (STATRS): A Randomized Controlled Trial of Pharmacological Optimization and Neuromodulation in Chinese Patients","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"SINGLE","sponsor":"Shanghai Mental Health Center","sponsorClass":"OTHER","summary":"The goal of this study is to optimize treatment strategies for Chinese patients with treatment-resistant schizophrenia (TRS). It will compare two types of treatment:\n\n1. Drug therapy with clozapine alone or in combination with other medications.\n2. Neuromodulation therapy, modified electroconvulsive therapy (MECT) or magnetic seizure therapy (MST).\n\nThe study aims to determine which approach provides better symptom improvement, fewer cognitive side effects, and greater overall safety. The results may provide important clinical evidence to guide future treatment decisions for patients with TRS.","conditions":["Treatment-resistant Schizophrenia"],"keywords":["Tratment-resistant schizophrenia","Clozapine combination therapy","Neuromodulation"],"interventions":[{"type":"DRUG","name":"[Phase 1] Clozapine"},{"type":"DRUG","name":"[Phase 1] Aripiprazole"},{"type":"DRUG","name":"[Phase 1] Amisulpride"},{"type":"DEVICE","name":"[Phase 2] Modified Electroconvulsive Therapy (MECT)"},{"type":"DEVICE","name":"[Phase 2] Magnetic Seizure Therapy (MST)"}],"enrollment":300,"startDate":"2026-09-01","completionDate":"2030-12-01","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nGeneral inclusion criteria applicable to all participants:\n\n* Aged 18 to 55 years at the time of informed consent.\n* Participants must meet DSM-5 diagnostic criteria for schizophrenia.\n* Meet TRRIP-based criteria for treatment-resistant schizophrenia, defined as inadequate response to at least two different antipsychotic treatment trials, each administered at an adequate dose equivalent to ≥600 mg/day chlorpromazine for a minimum duration of 6 weeks. Have moderate or greater functional impairment, operationalized as a Personal and Social Performance Scale (PSP) score ≤70. Treatment adherence will be evaluated based on available medical records, prescription history and caregiver report.\n\nEligibility for the pharmacological optimization phase:\n\n• Participants eligible for the pharmacological optimization phase must meet the general TRS criteria above and must be clozapine-naive.\n\nEligibility for the neuromodulation phase:\n\n* Participants eligible for the neuromodulation phase must meet the TRS criteria described above.\n* Participants may enter the neuromodulation phase through either of the following pathways:\n\n  1. Participants who have previously received clozapine treatment and are hospitalized due to symptom exacerbation or clinical worsening.\n  2. Clozapine-naive TRS participants who complete the pharmacological optimization phase and show inadequate response, defined as less than 25% reduction in PANSS total score at Week 8.\n\nExclusion Criteria:\n\n* Organic brain disease or neurological disorder that may account for psychotic symptoms, including epilepsy where clinically relevant.\n* Current psychoactive substance dependence or substance-related disorder.\n* Intellectual disability or Mental retardation.\n* Pregnancy, breastfeeding, or planning pregnancy during the study period.\n* Severe physical illness or medical contraindication to study medication, MECT, MST.\n* Extreme agitation, stupor, active suicidal risk, severe non-cooperation, or high-risk conditions.","locations":[{"facility":"Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"DengTang Liu, MD, PhD","phone":"+86-18017311138","email":"erliu110@126.com"}],"primaryOutcomes":["PANSS reduction rate at Week 8 during the pharmacological optimization phase","PANSS reduction rate at Week 4 during the neuromodulation phase"],"hasResults":false,"conditionSlugs":["schizophrenia"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Phase 3: testing [Phase 1] Clozapine for Treatment-resistant Schizophrenia","inPlainEnglish":"The goal of this study is to optimize treatment strategies for Chinese patients with treatment-resistant schizophrenia (TRS). It will compare two types of treatment: 1.","whoItsFor":["Ages 18 Years to 55 Years","General who can join applicable to all participants:","Participants must meet DSM-5 diagnostic criteria for schizophrenia","Eligibility for the pharmacological optimization phase:","Participants eligible for the pharmacological optimization phase must meet the general TRS criteria above and must be clozapine-who have not tried this kind of treatment before","Eligibility for the neuromodulation phase:","Participants eligible for the neuromodulation phase must meet the TRS criteria described above","Participants may enter the neuromodulation phase through either of the following pathways:"],"whoShouldSkip":["Organic brain disease or neurological disorder that may account for psychotic symptoms, including epilepsy where clinically relevant","Current psychoactive substance dependence or substance-related disorder","Intellectual disability or Mental retardation","Pregnancy, breastfeeding, or planning pregnancy during the study period","Severe physical illness or medical contraindication to study medication, MECT, MST","Extreme agitation, stupor, active suicidal risk, severe non-cooperation, or high-risk conditions"],"whatHappens":"If you join, the listed intervention(s) are [Phase 1] Clozapine, [Phase 1] Aripiprazole, or [Phase 1] Amisulpride. The registry lists allocation as randomized. The goal of this study is to optimize treatment strategies for Chinese patients with treatment-resistant schizophrenia (TRS).","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 300 people at Shanghai. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.040Z"},{"nctId":"NCT07918339","title":"Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis","officialTitle":"Virtual Reality Versus Mental Practice On Balance And Gait In Patients With Multiple Sclerosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Cairo University","sponsorClass":"OTHER","summary":"This study is conducted to:\n\n* Investigate the effect of virtual reality based training on balance and risk of falling.\n* Investigate the effect of virtual reality based training on gait.\n* Investigate the effect of mental practice on balance and risk of falling.\n* Investigate the effect of mental practice on gait.\n* Compare between the effect of virtual reality based training and mental practice on balance and gait","conditions":["Multiple Sclerosis"],"keywords":["Multiple Sclerosis,","Mental Practice","Virtual Reality","Balance","Gait"],"interventions":[{"type":"OTHER","name":"Mental Practice"},{"type":"OTHER","name":"Virtual Reality"},{"type":"OTHER","name":"Selected Physical Therapy Program"}],"enrollment":54,"startDate":"2026-03-01","completionDate":"2027-03-15","sex":"ALL","minAge":"20 Years","maxAge":"35 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Patients with RRMS.\n2. Patient's age will be range from 20 - 35 years..\n3. Patients are able to walk 10 meter with or without assistance.\n4. Patients with ≤ 6 according to an Expanded Disability Status Scale (EDSS).\n5. Patients are cognitively able to follow instructions.\n6. Patient's body mass index (BMI) will be ranged from 18.5 to 29.99 Kg/m2.\n\nExclusion Criteria:\n\n1. Patients with MS relapse in the last 30 days.\n2. Visual impairments interfering with VR.\n3. Severe spasticity or orthopaedic deformity.\n4. Recent musculoskeletal injury.\n5. History of epilepsy or motion sickness with VR.","locations":[{"facility":"Faculty of Physical Therapy, Cairo University","city":"Giza","state":"Giza Governorate","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ola Z Asal, BSc","phone":"00201023830508","email":"ola25jan@gmail.com"},{"name":"Nagwa I Rehab, PhD","phone":"00201008124920","email":"Nagwa1102010@yahoo.com"}],"primaryOutcomes":["Gait","Gait","Balance","Balance"],"hasResults":false,"conditionSlugs":["multiple-sclerosis"],"drugSlugs":[],"locationSlugs":["giza-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Mental Practice for Multiple Sclerosis","inPlainEnglish":"This study is conducted to: * Investigate the effect of virtual reality based training on balance and risk of falling. * Investigate the effect of virtual reality based training on gait.","whoItsFor":["Ages 20 Years to 35 Years","Patients with RRMS","Patient's age will be range from 20 - 35 years.","Patients are able to walk 10 meter with or without assistance","Patients with ≤ 6 according to an Expanded Disability Status Scale (EDSS)","Patients are cognitively able to follow instructions","Patient's body mass index (body-mass index (BMI)) will be ranged from 18.5 to 29.99 Kg/m2"],"whoShouldSkip":["Patients with MS relapse in the last 30 days","Visual impairments interfering with VR","Severe spasticity or orthopaedic deformity","Recent musculoskeletal injury","History of epilepsy or motion sickness with VR"],"whatHappens":"If you join, the listed intervention(s) are Mental Practice, Virtual Reality, or Selected Physical Therapy Program. The registry lists allocation as randomized. This study is conducted to: * Investigate the effect of virtual reality based training on balance and risk of falling.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 54 people at Giza. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.973Z"},{"nctId":"NCT07918378","title":"Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis","officialTitle":"Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Patients With Cirrhosis at University Medical Center Ho Chi Minh City","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Medical Center Ho Chi Minh City (UMC)","sponsorClass":"OTHER","summary":"BACKGROUND. Portal hypertension-related gastrointestinal bleeding (GIB), especially gastric variceal bleeding, is a critical complication of liver cirrhosis that is associated with high rebleeding and mortality rates. While endovascular interventions such as transjugular intrahepatic portosystemic shunt (TIPS) and retrograde/antegrade transvenous obliteration (RTO/ATO) represent major advances, real-world clinical data and localized prognostic models for patients undergoing these treatments are extremely sparse in Vietnam.\n\nOBJECTIVE. This study aims to describe the clinical and laboratory characteristics, evaluate technical and clinical treatment outcomes, and identify independent pre-procedural prognostic factors associated with adverse clinical outcomes after endovascular interventions.\n\nMETHODS. A hybrid cohort study combining a retrospective phase (January 2021 - September 2026, target n=117) and a prospective phase (October 2026 - March 2028, target n=50) will be conducted at the University Medical Center Ho Chi Minh City. The total sample size of 167 patients is powered using Cochran's single proportion formula and the rule of 10 events per variable (EPV) for logistic regression modeling. Demographics, lab markers, hepatic scoring systems (Child-Pugh, MELD, MELD-Na, MELD 3.0,...), procedural parameters, and clinical outcomes (initial bleeding control, rebleeding, in-hospital and 6-week mortality) will be recorded. Univariate and multivariate logistic and Cox proportional hazard regression will be used to analyze predictors of outcomes.\n\nIMPACT. The TOPIC study will establish the first systematic real-world clinical database of endovascular portal hypertension interventions in Vietnam. Defining localized prognostic variables will support risk stratification, optimize patient selection, lower healthcare costs, and establish practical guidelines for personalized clinical management.","conditions":["Cirrhosis","Portal Hypertension Related to Cirrhosis","GI Bleeding","Gastrointestinal Bleeding"],"keywords":["endovascular intervention","portal hypertension-related gastrointestinal bleeding","cirrhosis","TOPIC study","UMC","portal hypertension","TIPS","ATO","PARTO","CARTO"],"interventions":[{"type":"PROCEDURE","name":"Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding"}],"enrollment":167,"startDate":"2026-10-01","completionDate":"2028-08-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patient is aged 18 years or older on the day of admission.\n* Confirmed diagnosis of liver cirrhosis by attending clinicians based on clinical findings, laboratory tests, imaging studies (ultrasound, CT, MRI, elastography), or liver histology if available.\n* Diagnosis of acute portal hypertension-related gastrointestinal bleeding requiring treatment with at least one endovascular intervention technique (TIPS, PARTO, CARTO, ATO, or combined techniques).\n* For patients enrolled in the prospective cohort, signed and dated written informed consent must be obtained prior to study inclusion.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Non-cirrhotic portal hypertension, or liver cirrhosis that is unconfirmed or questionable.\n* Gastrointestinal bleeding due to etiologies completely unrelated to portal hypertension (e.g., peptic ulcer disease, gastric cancer, Mallory-Weiss tears, vascular ectasias), or bleeding of completely unknown origin.\n* Missing critical medical records or core pre-procedural/outcome data that would prevent the primary outcome assessment","locations":[{"facility":"University Medical Center Ho Chi Minh City","city":"Ho Chi Minh City","state":"","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Assoc. Professor. Thong Duy Vo, M.D. Ph.D.","phone":"+84 932039888","email":"thong.vd@umc.edu.vn"},{"name":"Qui Huu Nguyen, M.D.","phone":"+84 975560142","email":"qui.nh@umc.edu.vn"}],"primaryOutcomes":["Number of Participants With a Composite Adverse Clinical Outcome After Endovascular Intervention"],"hasResults":false,"conditionSlugs":["hypertension"],"drugSlugs":[],"locationSlugs":["ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding for Cirrhosis","inPlainEnglish":"Portal hypertension-related gastrointestinal bleeding (GIB), especially gastric variceal bleeding, is a critical complication of liver cirrhosis that is associated with high rebleeding and mortality rates. While endovascular interventions such as transjugular intrahepatic portosystemic shunt (TIPS) and retrograde/antegrade transvenous obliteration (RTO/ATO) represent major advances, real-world clinical data and localized prognostic models for patients undergoing these treatments are extremely sparse in Vietnam.","whoItsFor":["Ages 18 Years to any","Patient is aged 18 years or older on the day of admission","Confirmed diagnosis of liver cirrhosis by attending clinicians based on clinical findings, laboratory tests, imaging studies (ultrasound, CT, MRI, elastography), or liver histology if available","Diagnosis of acute portal hypertension-related gastrointestinal bleeding requiring treatment with at least one endovascular intervention technique (TIPS, PARTO, CARTO, ATO, or combined techniques)"],"whoShouldSkip":["Pregnant or lactating women","Non-cirrhotic portal hypertension, or liver cirrhosis that is unconfirmed or questionable","Gastrointestinal bleeding due to etiologies completely unrelated to portal hypertension (e.g., peptic ulcer disease, gastric cancer, Mallory-Weiss tears, vascular ectasias), or bleeding of completely unknown origin","Missing critical medical records or core pre-procedural/outcome data that would prevent the primary outcome assessment"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 167 people at Ho Chi Minh City. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.044Z"},{"nctId":"NCT07918690","title":"dPmax for Predicting Right Ventricular Failure After Left Ventricular Assist Device Implantation","officialTitle":"Predictive Value of dPmax Measured by Pulse Contour Analysis for Postoperative Right Ventricular Failure in Patients Undergoing LVAD Implantation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Pınar Kırdemir","sponsorClass":"OTHER","summary":"This single-center, prospective observational study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left ventricular assist device (LVAD) implantation in adults. Measurements collected during routine monitoring before and after anesthesia induction will be analyzed alongside preoperative echocardiographic findings. The primary outcome is right ventricular failure within 30 days after surgery, assessed using Mechanical Circulatory Support-Academic Research Consortium (MCS-ARC) criteria. Secondary objectives include comparing the predictive performance of dPmax with the ratio of tricuspid annular plane systolic excursion to pulmonary artery systolic pressure (TAPSE/SPAP) and identifying an optimal dPmax threshold for predicting right ventricular failure. No additional invasive procedures will be performed for research purposes.","conditions":["Ventricular Dysfunction, Right"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"Arterial Pulse Contour Analysis"}],"enrollment":89,"startDate":"2026-06-03","completionDate":"2029-09","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older.\n* Scheduled for left ventricular assist device (LVAD) implantation.\n* Availability of the clinical data required for the study.\n* Willingness and ability to provide informed consent.\n\nExclusion Criteria:\n\n* Congenital heart disease associated with transposition of the great arteries.\n* Ongoing extracorporeal membrane oxygenation (ECMO) or extracorporeal ventricular assist device (ExVAD) support immediately before LVAD implantation.\n* Severe aortic regurgitation, severe peripheral arterial disease, or refractory and uncontrolled tachyarrhythmia that may interfere with arterial waveform analysis.\n* Unwillingness to participate or cognitive impairment preventing informed consent.","locations":[{"facility":"Ankara Bilkent City Hospital","city":"Ankara","state":"Çankaya","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Right Ventricular Failure Within 30 Days After LVAD Implantation"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["ankara-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Arterial Pulse Contour Analysis for Ventricular Dysfunction, Right","inPlainEnglish":"This single-center, prospective watch-and-measure (no experimental treatment required) study aims to evaluate whether dPmax, a measure of the maximum rate of arterial pressure rise obtained through pulse contour analysis, can predict right ventricular failure after left ventricular assist device (LVAD) implantation in adults. Measurements collected during routine monitoring before and after anesthesia induction will be analyzed alongside preoperative echocardiographic findings.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Scheduled for left ventricular assist device (LVAD) implantation","Availability of the clinical data required for the study"],"whoShouldSkip":["Congenital heart disease associated with transposition of the great arteries","Ongoing extracorporeal membrane oxygenation (ECMO) or extracorporeal ventricular assist device (ExVAD) support immediately before LVAD implantation","Severe aortic regurgitation, severe peripheral arterial disease, or refractory and uncontrolled tachyarrhythmia that may interfere with arterial waveform analysis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 89 people at Ankara. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:17.436Z"},{"nctId":"NCT07919236","title":"Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin","officialTitle":"Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin - the Association With Metabolic Control of Diabetes and Markers of Early Vascular Changes","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Medical University of Bialystok","sponsorClass":"OTHER","summary":"The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin. Additionally, the study aims to assess the association between metabolic control of diabetes and markers of early cardiovascular disease, taking into account the impact of CGM use.","conditions":["Type 2 Diabetes"],"keywords":["type 2 diabetes","continuous glucose monitoring","non-insulin treated type 2 diabetes"],"interventions":[{"type":"DEVICE","name":"Continuous glucose monitoring"},{"type":"DEVICE","name":"Self-monitoring of blood glucose"}],"enrollment":50,"startDate":"2026-11","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 65 years (both inclusive)\n* Type 2 diabetes diagnosed at least 6 months prior to entering the study\n* Body mass index ≥25 kg/m2\n* Diabetes treated with oral medications and/or GLP-1 receptor agonists and/or tirzepatide\n* No modifications of diabetes treatment in the previous 3 months\n* HbA1c between 7.5% and 10% (both inclusive)\n* Oral and written informed consent for participation\n\nExclusion Criteria:\n\n* Type 1 diabetes, gestational diabetes, other specific types of diabetes\n* HbA1c \\>10.0%\n* Treatment with insulin\n* Previous use of any continuous glucose monitoring system\n* GFR \\<30 ml/min\n* Acute infections, acute diabetes complications and/or unplanned hospitalisations in the previous month\n* Use of steroids or immunosuppressive medications in the previous 3 months\n* Chemotherapy, radiotherapy, immune therapy in the previous 3 months\n* Pregnancy and/or breastfeeding\n* Skin lesions or dermatological conditions preventing proper sensor insertion\n* Cognitive impairment and/or other conditions preventing proper use of continuous glucose monitoring system\n* Lack of consent for the use of continuous glucose monitoring system","locations":[{"facility":"Medical University of Bialystok, Department of Internal Medicine and Metabolic Diseases","city":"Bialystok","state":"","country":"Poland","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anna Krentowska, MD, PhD","phone":"+48858317761","email":"anna.krentowska@umb.edu.pl"}],"primaryOutcomes":["Change in time in range"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["bialystok-poland"],"enrichment":{"headline":"Not a traditional drug phase: Continuous glucose monitoring for Type 2 Diabetes","inPlainEnglish":"The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin. Additionally, the study aims to assess the association between metabolic control of diabetes and markers of early cardiovascular disease, taking into account the impact of CGM use.","whoItsFor":["Ages 18 Years to 65 Years","Age between 18 and 65 years (both inclusive)","Type 2 diabetes diagnosed at least 6 months prior to entering the study","Body mass index ≥25 kg/m2","Diabetes treated with oral medications and/or GLP-1 receptor agonists and/or tirzepatide","No modifications of diabetes treatment in the previous 3 months","HbA1c between 7.5% and 10% (both inclusive)"],"whoShouldSkip":["Type 1 diabetes, gestational diabetes, other specific types of diabetes","Treatment with insulin","Previous use of any continuous glucose monitoring system","Acute infections, acute diabetes complications and/or unplanned hospitalisations in the previous month","Use of steroids or immunosuppressive medications in the previous 3 months","Chemotherapy, radiotherapy, immune therapy in the previous 3 months","Pregnancy and/or breastfeeding"],"whatHappens":"If you join, the listed intervention(s) are Continuous glucose monitoring, or Self-monitoring of blood glucose. The registry lists allocation as randomized. The aim of the study is to assess the influence of continuous glucose monitoring (CGM) systems on metabolic control and quality of life in people with type 2 diabetes and overweight/obesity who are not treated with insulin.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Bialystok. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.525Z"},{"nctId":"NCT07919678","title":"A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)","officialTitle":"A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF ONCE-MONTHLY BEROBENATIDE IN ADULTS WITH KNEE OSTEOARTHRITIS AND OVERWEIGHT OR OBESITY (VESPER-OA 1)","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Pfizer","sponsorClass":"INDUSTRY","summary":"The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity. The study will last 52 weeks and compare the effects of berobenatide compared to placebo on knee pain, physical function, and body weight. Study activities will include blood tests, knee pain assessment, physical function questionnaires and body measurements.","conditions":["Obesity","Overweight","Osteoarthritis of the Knee"],"keywords":["Knee Pain","Osteoarthritis","Weight Management","Knee Osteoarthritis","Obesity","Overweight","GLP1","GLP1-RA","WOMAC"],"interventions":[{"type":"DRUG","name":"Berobenatide"},{"type":"OTHER","name":"Placebo"}],"enrollment":656,"startDate":"2026-10-26","completionDate":"2028-08-22","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults 18 years of age or older, or the minimum age of consent according to local regulations.\n* Body mass index of at least 27 kg/m² at Screening.\n* Currently meets American College of Rheumatology (ACR) Criteria for knee OA.\n* Pain due to knee OA.\n* Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3.\n* Willingness to complete the required analgesic washout.\n* History of at least 1 self-reported unsuccessful dietary effort to lose body weight.\n\nExclusion Criteria\n\n* Self-reported body weight increase or decrease greater than 5% within 90 days before Screening.\n* History of diabetes or Screening laboratory findings indicative of diabetes.\n* Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease.\n* Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.\n* Significant active or unstable psychiatric disorder.\n* Condition or knee disorder that could confound assessment of target-knee pain.\n* Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study.\n* Recent use of weight-loss medication, any glucose-lowering therapy, or other protocol-prohibited treatment.\n* Prior participation in a berobenatide clinical trial with receipt of active treatment or placebo.\n* Hypersensitivity to a drug with glucagon-like peptide-1 receptor activity, including berobenatide, or any excipient.","locations":[{"facility":"AMR Clinical","city":"Tempe","state":"Arizona","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Headlands Research California, LLC","city":"Escondido","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Prospective Research Innovations Inc.","city":"Rancho Cucamonga","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Solace Clinical Research","city":"Tustin","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Skylight Health Research","city":"Colorado Springs","state":"Colorado","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida, Inc.","city":"Clearwater","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Universal Axon Clinical Research LLC","city":"Doral","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Westside Center for Clinical Research","city":"Jacksonville","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Lady Lake","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Renstar Medical Research","city":"Ocala","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research of West Florida, Inc.","city":"Tampa","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Clinical Research Atlanta","city":"Stockbridge","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Clinical Research, LLC","city":"Woodstock","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"North Georgia Internal Medicine","city":"Woodstock","state":"Georgia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Memorial Hospital, Diagnostic Testing Center (Phlebotomy/EKG)","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern Memorial Hospital, Investigational Drug Service","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Northwestern University Feinberg School Of Medicine","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Great Lakes Clinical Trials, LLC dba Flourish Research","city":"Chicago","state":"Illinois","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Elevate Clinical Research","city":"Wichita","state":"Kansas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"BRCR Global Louisiana","city":"Gretna","state":"Louisiana","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Profound Research LLC","city":"Farmington Hills","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Revive Research Institute, Inc.","city":"Sterling Heights","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Albuquerque Clinical Trials, Inc.","city":"Albuquerque","state":"New Mexico","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Novant Health Granite Quarry Internal Medicine (knee x-ray)","city":"Granite Quarry","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Monroe Biomedical Research","city":"Monroe","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Accellacare - Salisbury","city":"Salisbury","state":"North Carolina","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Accellacare","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Delaney Radiologist","city":"Wilmington","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"AMR Clinical","city":"Norman","state":"Oklahoma","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Altoona Center For Clinical Research","city":"Duncansville","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Mercy Family Clinic","city":"Dallas","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cedar Health Research","city":"Fort Worth","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"JCCT-JUNO NW Houston","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Activian Clinical Research","city":"Kingwood","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Consano Clinical Research, LLC","city":"Shavano Park","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"DM Clinical Research","city":"Tomball","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Velocity Clinical Research, Waco","city":"Waco","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Charlottesville Medical Research Center, LLC","city":"Charlottesville","state":"Virginia","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Bluewater Clinical Research Group Inc.","city":"Sarnia","state":"Ontario","country":"Canada","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pfizer CT.gov Call Center","phone":"1-800-718-1021","email":"ClinicalTrials.gov_Inquiries@pfizer.com"}],"primaryOutcomes":["Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale score"],"hasResults":false,"conditionSlugs":["obesity","osteoarthritis"],"drugSlugs":[],"locationSlugs":["tempe-arizona","escondido-california","rancho-cucamonga-california","tustin-california","colorado-springs-colorado","clearwater-florida","doral-florida","jacksonville-florida","lady-lake-florida","ocala-florida","tampa-florida","stockbridge-georgia","woodstock-georgia","chicago-illinois","wichita-kansas","gretna-louisiana","farmington-hills-michigan","sterling-heights-michigan","albuquerque-new-mexico","granite-quarry-north-carolina","monroe-north-carolina","salisbury-north-carolina","wilmington-north-carolina","norman-oklahoma","duncansville-pennsylvania","dallas-texas","fort-worth-texas","houston-texas","kingwood-texas","shavano-park-texas","tomball-texas","waco-texas","charlottesville-virginia","sarnia-canada"],"enrichment":{"headline":"Phase 3: testing Berobenatide for Obesity","inPlainEnglish":"The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity. The study will last 52 weeks and compare the effects of berobenatide compared to dummy treatment (placebo) on knee pain, physical function, and body weight.","whoItsFor":["Ages 18 Years to any","Adults 18 years of age or older, or the minimum age of consent according to local regulations","Body mass index of at least 27 kg/m² at Screening","Currently meets American College of Rheumatology (ACR) Criteria for knee OA","Pain due to knee OA","Knee radiograph consistent with knee osteoarthritis and Kellgren-Lawrence Grade 2 or 3","Willingness to complete the required analgesic washout","History of at least 1 self-reported unsuccessful dietary effort to lose body weight"],"whoShouldSkip":["Self-reported body weight increase or decrease greater than 5% within 90 days before Screening","History of diabetes or Screening laboratory findings indicative of diabetes","Known clinically significant gastric-emptying abnormality, history of acute or chronic pancreatitis, or active symptomatic gallbladder disease","Personal history or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2","Significant active or unstable psychiatric disorder","Condition or knee disorder that could confound assessment of target-knee pain","Prior target-knee replacement, planned target-knee replacement, or planned elective knee surgery during the study"],"whatHappens":"If you join, the listed intervention(s) are Berobenatide, or Placebo. The registry lists allocation as randomized. The purpose of this clinical study is to learn about the safety and effects of berobenatide (PF-08653944) for the treatment of knee osteoarthritis in adults with overweight or obesity.","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 656 people at 40 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.513Z"},{"nctId":"NCT07920068","title":"Epinephrine 1:100,000 Versus 1:500,000 During Gastric Endoscopic Submucosal Dissection","officialTitle":"Optimal Epinephrine Concentration in Gastric Endoscopic Submucosal Dissection: A Prospective Randomized Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Unidade Local de Saúde do Alto Ave, EPE","sponsorClass":"OTHER","summary":"This prospective, randomized, single-center trial compares two epinephrine concentrations (1:100,000 and 1:500,000) in the submucosal injection solution used during gastric endoscopic submucosal dissection. The study evaluates whether the lower epinephrine concentration can maintain procedural efficiency while reducing epinephrine dose, without compromising hemostatic efficacy or safety. A total of 100 participants are planned.","conditions":["Gastric Neoplasms","Gastric Dysplasia"],"keywords":["Gastric endoscopic submucosal dissection","Epinephrine","Adrenaline","Gastric neoplasia","Gastric dysplasia"],"interventions":[{"type":"DRUG","name":"Epinephrine 1:100,000"},{"type":"DRUG","name":"Epinephrine 1:500,000"}],"enrollment":100,"startDate":"2025-07-30","completionDate":"2027-02-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older.\n* Patients scheduled to undergo gastric endoscopic submucosal dissection (ESD) for a dysplastic or neoplastic gastric lesion.\n* Ability to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Refusal or inability to provide informed consent.\n* Contraindication to any component of the submucosal injection solution used in the study.\n* Any clinical condition considered by the investigator to preclude safe participation in the study.","locations":[{"facility":"Unidade Local de Saúde do Alto Ave","city":"Guimarães","state":"Braga District","country":"Portugal","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Mariana Souto, MD","phone":"+351914114648","email":"mariana.souto9@gmail.com"},{"name":"Unidade Local de Saúde do Alto Ave","phone":"+351 253 540 330","email":"geral@ulsaave.min-saude.pt"}],"primaryOutcomes":["Gastric ESD procedure time"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["guimar-es-portugal"],"enrichment":{"headline":"Not a traditional drug phase: testing Epinephrine 1:100,000 for Gastric Neoplasms","inPlainEnglish":"This prospective, randomly assigned, single-center trial compares two epinephrine concentrations (1:100,000 and 1:500,000) in the submucosal injection solution used during gastric endoscopic submucosal dissection. The study evaluates whether the lower epinephrine concentration can maintain procedural efficiency while reducing epinephrine dose, without compromising hemostatic how well it works or safety.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Patients scheduled to undergo gastric endoscopic submucosal dissection (ESD) for a dysplastic or neoplastic gastric lesion"],"whoShouldSkip":["Contraindication to any component of the submucosal injection solution used in the study","Any clinical condition considered by the investigator to preclude safe participation in the study"],"whatHappens":"If you join, the listed intervention(s) are Epinephrine 1:100,000, or Epinephrine 1:500,000. The registry lists allocation as randomized. This prospective, randomly assigned, single-center trial compares two epinephrine concentrations (1:100,000 and 1:500,000) in the submucosal injection solution used during gastric endoscopic submucosal dissection.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Guimarães. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.976Z"},{"nctId":"NCT07920081","title":"Psilocybin for Amblyopia - Targeting Critical Periods in Humans","officialTitle":"Psilocybin for Amblyopia - Targeting Critical Periods in Humans (PATCH)","status":"RECRUITING","phases":["PHASE1","PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Johns Hopkins University","sponsorClass":"OTHER","summary":"The purpose of this study is to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms. It can be ingested orally and can result in strong but short-term (4-6 hours) effects such as changes in perception, thoughts, and emotions.","conditions":["Amblyopia"],"keywords":["lazy eye","psilocybin","amblyopia","anisometropia","refractive amblyopia","anisometropic amblyopia","psychedelic"],"interventions":[{"type":"BEHAVIORAL","name":"Amblyopia Therapy"},{"type":"DRUG","name":"1 mg Psilocybin"},{"type":"DRUG","name":"5 mg Psilocybin"},{"type":"DRUG","name":"10 mg Psilocybin"},{"type":"DRUG","name":"15 mg Psilocybin"},{"type":"DRUG","name":"20 mg Psilocybin"},{"type":"DRUG","name":"25 mg Psilocybin"}],"enrollment":24,"startDate":"2026-11","completionDate":"2028-07","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 18 to 65 years old\n* Have given written informed consent\n* Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English\n* Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, medical history and physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Women who are of child-bearing potential and sexually active agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g. coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.\n* Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.\n* Agree not to take any as needed (PRN) medications on the mornings of drug sessions\n* Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n* Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n* Have a clinical diagnosis of amblyopia, with best-corrected visual acuity in the range of 0.2 - 1.0 LogMAR (approximately equivalent to 20/30 to 20/200)\n* Has undergone an eye exam and prescription assessment within a recent period\n* Has been wearing current spectacle correction for a minimum of six weeks prior to enrollment\n\nExclusion Criteria:\n\n* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing highly effective means of birth control (i.e. those that result in \\<1% failure rate per year; note that condoms alone are not considered highly effective)\n* Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation), artificial heart valve, or transient ischemic attack (TIA) in the past year\n* Epilepsy with history of seizures\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking on a regular (e.g. daily) basis any medications having a primary centrally-acting serotonergic effect, including monoamine oxidase inhibitor (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.\n* Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)\n* Current or past history within the last five years of meeting DSM-5 criteria for a severe alcohol or drug use disorder (excluding caffeine and nicotine)\n* Have a first-degree relative with bipolar I disorder, schizophrenia spectrum, or other psychotic disorders (except substance/medication-induced or due to another medical condition)\n* Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin\n* Explanation for visual acuity loss other than amblyopia, including cataracts, corneal disease, optic neuropathy, retinopathy, glaucoma, history of eye trauma or intraocular surgery, or any other ocular pathology as determined by study ophthalmologist","locations":[{"facility":"Johns Hopkins Center for Psychedelic and Consciousness Research","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Brian Winston","phone":"410-550-2253","email":"bwinsto2@jh.edu"}],"primaryOutcomes":["Change in Amblyopic Eye Visual Acuity","Change in Fellow Eye Visual Acuity"],"hasResults":false,"conditionSlugs":[],"drugSlugs":["psilocybin"],"locationSlugs":["baltimore-maryland"],"enrichment":{"headline":"Phase 1 / Phase 2: testing 1 mg Psilocybin for Amblyopia","inPlainEnglish":"This study wants to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia. Psilocybin is a naturally-occurring psychoactive compound found in many species of mushrooms.","whoItsFor":["Ages 18 Years to 65 Years","Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English","Women who are of child-bearing potential and sexually active agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study","Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine","Agree not to take any as needed (PRN) medications on the mornings of drug sessions","Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration","Have a clinical diagnosis of amblyopia, with best-corrected visual acuity in the range of 0.2 - 1.0 LogMAR (approximately equivalent to 20/30 to 20/200)","Has undergone an eye exam and prescription assessment within a recent period"],"whoShouldSkip":["Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation), artificial heart valve, or transient ischemic attack (TIA) in the past year","Epilepsy with history of seizures","Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia","Current or past history of meeting DSM-5 criteria for schizophrenia spectrum or other psychotic disorders (except substance/medication-induced or due to another medical condition)","Current or past history within the last five years of meeting DSM-5 criteria for a severe alcohol or drug use disorder (excluding caffeine and nicotine)","Have a first-degree relative with bipolar I disorder, schizophrenia spectrum, or other psychotic disorders (except substance/medication-induced or due to another medical condition)","Has a psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin"],"whatHappens":"If you join, the listed intervention(s) are Amblyopia Therapy, 1 mg Psilocybin, or 5 mg Psilocybin. The registry lists allocation as randomized. This study wants to evaluate whether ingestion of a drug called psilocybin can increase the effectiveness of amblyopia therapy in adults with amblyopia.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 24 people at Baltimore. Taking part typically means taking a study drug (or dummy pill), following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:24.093Z"},{"nctId":"NCT07920094","title":"Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery","officialTitle":"Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Sir Run Run Shaw Hospital","sponsorClass":"OTHER","summary":"This multicenter, open-label, prospective, randomized controlled study compares a novel endoscopy-assisted breast-conserving surgery technique (SRRSHzb-EABCS) with conventional open breast-conserving surgery (CBCS) in women with breast cancer who wish to preserve their breast.\n\nBreast-conserving surgery followed by radiotherapy is a standard treatment for early-stage breast cancer. Conventional open surgery leaves visible scars on the breast, while traditional endoscopy-assisted techniques are time-consuming, difficult to learn, and costly. The investigators developed a novel technique, SRRSHzb-EABCS, which uses a gasless expansion-traction endoscopic system with a custom-built skin flap dissector and V-shaped retractor, together with percutaneous U-shaped metal wires placed around the marked tumor margin, enabling precise tumor localization and margin control through a single axillary incision. The technique is designed to be easier to learn, shorter in operative time, less expensive, and more cosmetic.\n\nEligible participants are randomly assigned in a 1:1 ratio to undergo either SRRSHzb-EABCS or conventional open breast-conserving surgery. The main goal of the study is to compare the intraoperative and postoperative positive margin rates between the two techniques. The study also compares aesthetic outcomes measured by BREAST-Q scores at 1 and 18 months after surgery, complication rates, and 5-year local recurrence, disease-free survival, and overall survival.\n\nA total of 422 participants (211 per arm) will be enrolled at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and multiple participating centers in China. Participants are followed at 1 month and 18 months after surgery, with long-term follow-up for up to 5 years.","conditions":["Breast Cancer"],"keywords":["Breast-conserving surgery","Endoscopy-assisted breast-conserving surgery","SRRSHzb-EABCS","Positive margin rate","BREAST-Q","Aesthetic outcome"],"interventions":[{"type":"PROCEDURE","name":"Endoscopy-assisted breast-conserving surgery (SRRSHzb-EABCS)"},{"type":"PROCEDURE","name":"Conventional open breast-conserving surgery (CBCS)"}],"enrollment":422,"startDate":"2023-07-01","completionDate":"2029-01-31","sex":"FEMALE","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Female;\n2. Aged 18-70 years;\n3. Preoperative pathologically confirmed diagnosis of breast cancer, treated at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (lead center) or other participating centers;\n4. Voluntary participation in the study with signed informed consent;\n5. Desire for breast conservation;\n6. Clinical stage I-II early breast cancer: tumor size T1-T2, with adequate breast volume and an appropriate tumor-to-breast volume ratio, such that a satisfactory breast shape can be maintained after surgery;\n7. Selected patients with clinical stage III disease (except inflammatory breast cancer) who meet the criteria for breast-conserving surgery after downstaging by preoperative therapy may be carefully considered;\n8. Signed informed consent and willingness to receive standard postoperative adjuvant therapy and long-term follow-up.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. History of radiotherapy to the ipsilateral chest wall;\n3. Severe dysfunction of major organs, such as heart or lung;\n4. History of other malignant tumors;\n5. Extensive lesions for which negative margins or a satisfactory cosmetic outcome cannot be achieved;\n6. Diffusely distributed malignant-appearing calcifications;\n7. Multifocal or multicentric lesions;\n8. Positive dimple sign;\n9. Preoperative imaging indicating invasion of the skin or pectoralis major;\n10. Refusal to enter the randomization process;\n11. Vulnerable populations, including persons with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, and illiterate persons.","locations":[{"facility":"Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Sir Run Run Shaw Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Second Affiliated Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Women's Hospital, Zhejiang University School of Medicine","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Cancer Hospital, Institute of Basic Medicine and Cancer (IBMC), Chinese Academy of Sciences","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Zhejiang Provincial People's Hospital","city":"Hangzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Huzhou Central Hospital","city":"Huzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Affiliated Jinhua Hospital, Zhejiang University School of Medicine","city":"Jinhua","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Lishui Municipal Central Hospital","city":"Lishui","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo First Hospital","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo Medical Center Lihuili Hospital","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo No.2 Hospital","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Ningbo Women and Children's Hospital","city":"Ningbo","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Quzhou People's Hospital","city":"Quzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shangyu People's Hospital","city":"Shaoxing","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Shaoxing People's Hospital (Shaoxing Hospital, Zhejiang University School of Medicine)","city":"Shaoxing","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Central Hospital (Taizhou University Hospital)","city":"Taizhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Taizhou Hospital of Zhejiang Province","city":"Taizhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The First Affiliated Hospital of Wenzhou Medical University","city":"Wenzhou","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Yiwu Maternity and Children Hospital","city":"Yiwu","state":"Zhejiang","country":"China","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Linbo Wang","phone":"+86 135 8870 6949","email":"linbowang@zju.edu.cn"},{"name":"Yi Lu","phone":"+86 150 8868 1831","email":"yiluzju@zju.edu.cn"}],"primaryOutcomes":["Intraoperative and Postoperative Positive Margin Rate"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["hangzhou-china","huzhou-china","jinhua-china","lishui-china","ningbo-china","quzhou-china","shaoxing-china","taizhou-china","wenzhou-china","yiwu-china"],"enrichment":{"headline":"Not a traditional drug phase: Endoscopy-assisted breast-conserving surgery (SRRSHzb-EABCS) for Breast Cancer","inPlainEnglish":"This multicenter, open-label, prospective, randomly assigned controlled study compares a novel endoscopy-assisted breast-conserving surgery technique (SRRSHzb-EABCS) with conventional open breast-conserving surgery (CBCS) in women with breast cancer who wish to preserve their breast. Breast-conserving surgery followed by radiotherapy is a standard treatment for early-stage breast cancer.","whoItsFor":["Ages 18 Years to 70 Years","Women only","Preoperative pathologically confirmed diagnosis of breast cancer, treated at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (lead center) or other participating centers;","Desire for breast conservation;","Clinical stage I-II early breast cancer: tumor size T1-T2, with adequate breast volume and an appropriate tumor-to-breast volume ratio, such that a satisfactory breast shape can be maintained after surgery;","Selected patients with clinical stage III disease (except inflammatory breast cancer) who meet the criteria for breast-conserving surgery after downstaging by preoperative therapy may be carefully considered;"],"whoShouldSkip":["Pregnant or lactating women;","History of radiotherapy to the ipsilateral chest wall;","Severe dysfunction of major organs, such as heart or lung;","History of other malignant tumors;","Extensive lesions for which negative margins or a satisfactory cosmetic outcome cannot be achieved;","Diffusely distributed malignant-appearing calcifications;","Multifocal or multicentric lesions;"],"whatHappens":"If you join, the listed intervention(s) are Endoscopy-assisted breast-conserving surgery (SRRSHzb-EABCS), or Conventional open breast-conserving surgery (CBCS). The registry lists allocation as randomized. This multicenter, open-label, prospective, randomly assigned controlled study compares a novel endoscopy-assisted breast-conserving surgery technique (SRRSHzb-EABCS) with conventional open breast-conserving surgery (CBCS) in women with breast cancer who wish to preserve their breast.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 422 people at 22 sites. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.976Z"},{"nctId":"NCT07920120","title":"Effects of Virtual Reality Environments on Walking in Adults With and Without Knee Osteoarthritis","officialTitle":"Validation of VR Strategies for Knee Osteoarthritis Rehabilitation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of Primorska","sponsorClass":"OTHER","summary":"Knee osteoarthritis (KOA) is a common musculoskeletal condition associated with pain, impaired physical function, and movement-related fear. Psychological factors, particularly fear of movement (kinesiophobia), may influence movement behavior and limit participation in physical activity and exercise therapy. Immersive virtual reality (VR) provides an opportunity to modify the visual environment and potentially influence how individuals perceive safety and threat during movement. However, it remains unclear how VR-induced perceptions of safety and fear affect gait biomechanics, particularly in individuals with KOA.\n\nThe aim of this study is to investigate the effects of immersive VR environments designed to promote safety or induce fear on gait biomechanics and psychological responses in individuals with KOA and healthy adults aged 50 years and older.\n\nParticipants will perform walking tasks under five experimental conditions: walking without VR, walking in a neutral VR environment, walking in a safety-promoting VR environment on low ground, walking in a fear-inducing VR environment, and walking in a safety-promoting VR environment on high ground.\n\nDuring each condition, participants will walk along a straight 6-meter walkway at their preferred comfortable speed. Gait biomechanics will be assessed using an inertial motion capture system and force platforms. The primary outcome will be gait speed. Additional biomechanical parameters and subjective responses, including perceived fear, safety, and VR-related experiences, will also be assessed.\n\nThe study aims to determine whether VR environments that alter perceived safety and fear influence walking patterns and whether these responses differ between individuals with KOA and healthy adults. It is hypothesized that fear-inducing VR environments will alter gait biomechanics, particularly gait speed, compared with neutral and safety-promoting conditions.","conditions":["Knee Osteoarthritis"],"keywords":["virtual reality","knee osteoarthritis","Gait Biomechanics","Kinesiophobia","Fear of Falling","Gait Speed"],"interventions":[{"type":"BEHAVIORAL","name":"Immersive Virtual Reality Walking Conditions"},{"type":"BEHAVIORAL","name":"Non-VR Walking"}],"enrollment":60,"startDate":"2026-08-26","completionDate":"2026-11-30","sex":"ALL","minAge":"50 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Knee Osteoarthritis (KOA) Group:\n\nInclusion criteria:\n\n* Age 50 years or older.\n* Diagnosis of knee osteoarthritis in one or both knees, confirmed according to the clinical and radiographic criteria of the American College of Rheumatology.\n* Knee pain and radiographically confirmed osteophytes, together with at least one of the following: age over 50 years, morning stiffness lasting less than 30 minutes, or crepitus during active knee movement.\n\nExclusion criteria:\n\nParticipants will be excluded from the studies if they:\n\n* are younger than 50 years;\n* are on a waiting list for knee arthroplasty within the next year;\n* have sustained an acute knee injury within the previous 6 months;\n* have knee pain unrelated to KOA;\n* have a knee or hip arthroplasty;\n* have undergone surgery of the back, hip, knee, ankle, or foot within the previous 12 months;\n* have health conditions or musculoskeletal limitations that affect strengthening exercise and limit physical function to a greater extent than knee pain (e.g., low back pain or hip pain);\n* have concomitant systemic inflammatory diseases such as rheumatoid arthritis or gout; neurological conditions (Alzheimer's disease, Parkinson's disease, or metabolic diseases affecting the nervous system); muscular or joint diseases/injuries affecting lower-limb function (e.g., osteoarthritis of the hip and/or ankle, sprains, fractures); or internal medical conditions (cardiovascular, pulmonary and/or oncological diseases, or diabetes with late complications such as diabetic foot or neuropathy) that affect physical capacity;\n* have a history of stroke or myocardial infarction resulting in motor and/or cognitive impairments (including inability to provide informed consent);\n* have balance disorders known to be caused by vestibular dysfunction;\n* have a body mass index (BMI) \\>32 kg/m²;\n* have received intra-articular corticosteroid and/or hyaluronic acid injections within the previous 6 months;\n* have diagnosed epilepsy or a history of epileptic seizures, particularly photosensitive epilepsy;\n* experience frequent or severe migraines triggered by visual stimuli;\n* have severe visual impairments that are not adequately corrected;\n* have previously experienced pronounced adverse effects when using virtual reality (e.g., severe nausea, vomiting, marked dizziness, or severe disorientation).\n\nHealthy Control Group:\n\nInclusion criteria:\n\n* Age 50 years or older.\n* No significant gait disturbances.","locations":[{"facility":"Vilnius Gediminas Technical University","city":"Vilnius","state":"","country":"Lithuania","status":"COMPLETED","lat":null,"lon":null},{"facility":"University of Primorska, Faculty of Health Sciences","city":"Izola","state":"","country":"Slovenia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Nejc Šarabon","phone":"+386 05/66-26-460","email":"nejc.sarabon@fvz.upr.si"}],"primaryOutcomes":["Gait Speed"],"hasResults":false,"conditionSlugs":["als","osteoarthritis"],"drugSlugs":[],"locationSlugs":["vilnius-lithuania","izola-slovenia"],"enrichment":{"headline":"Not a traditional drug phase: Immersive Virtual Reality Walking Conditions for Knee Osteoarthritis","inPlainEnglish":"Knee osteoarthritis (KOA) is a common musculoskeletal condition associated with pain, impaired physical function, and movement-related fear. Psychological factors, particularly fear of movement (kinesiophobia), may influence movement behavior and limit participation in physical activity and exercise therapy.","whoItsFor":["Ages 50 Years to any","Knee Osteoarthritis (KOA) Group:","Age 50 years or older","Diagnosis of knee osteoarthritis in one or both knees, confirmed according to the clinical and radiographic criteria of the American College of Rheumatology","Knee pain and radiographically confirmed osteophytes, together with at least one of the following: age over 50 years, morning stiffness lasting less than 30 minutes, or crepitus during active knee movement"],"whoShouldSkip":["you would be excluded from the studies if they:","are younger than 50 years;","are on a waiting list for knee arthroplasty within the next year;","have sustained an acute knee injury within the previous 6 months;","have knee pain unrelated to KOA;","have a knee or hip arthroplasty;","have undergone surgery of the back, hip, knee, ankle, or foot within the previous 12 months;"],"whatHappens":"If you join, the listed intervention(s) are Immersive Virtual Reality Walking Conditions, or Non-VR Walking. The registry lists allocation as na. Knee osteoarthritis (KOA) is a common musculoskeletal condition associated with pain, impaired physical function, and movement-related fear.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at 2 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:16.511Z"},{"nctId":"NCT07920224","title":"Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma","officialTitle":"Single-Arm, Multicenter, Phase II Study of Candonilimab Combined With Fruquintinib With or Without Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First-Line Therapy Containing a PD-(L)1 Inhibitor","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","sponsorClass":"OTHER","summary":"This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","conditions":["Stomach Neoplasms"],"keywords":[],"interventions":[{"type":"DRUG","name":"candonilimab combined with fruquintinib and paclitaxel albumin-bound"}],"enrollment":59,"startDate":"2025-07-19","completionDate":"2027-06-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Have a full understanding of the study and voluntarily sign the informed consent form;\n2. Aged 18 to 75 years (inclusive);\n3. Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma;\n4. Prior failure of first-line standard chemotherapy;\n5. HER2-negative status;\n6. ECOG performance status of 0 to 2;\n7. Expected survival of ≥3 months;\n8. Presence of at least one measurable lesion, defined as:\n\n   * Longest diameter ≥10 mm as assessed by spiral CT scan;\n   * Diameter ≥20 mm as assessed by conventional CT scan(per Response Evaluation Criteria in Solid Tumors, RECIST version 1.1);\n9. Major organ function meeting the following requirements (use of any blood products or hematopoietic growth factors within 14 days prior to enrollment is not permitted):\n\n   * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L;\n   * Platelet (PLT) count ≥100 × 10⁹/L;\n   * Hemoglobin (Hb) ≥90 g/L;\n   * Total bilirubin (TBIL) \\<1.5 × upper limit of normal (ULN);\n   * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\<1.5 × ULN (or \\<3 × ULN for patients with liver metastases);\n   * Serum creatinine \\<1.5 × ULN;\n   * Creatinine clearance rate (CCr) ≥50 ml/min;\n10. Men and women of childbearing potential must agree to use effective contraceptive measures;\n11. Willingness to provide sufficient tumor tissue samples for PD-L1 expression testing.\n\nExclusion Criteria:\n\nPatients will be excluded from this study if they meet any of the following criteria:\n\n1. Inability to comply with the study protocol or study procedures;\n2. Prior treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or prior use of immune checkpoint inhibitors;\n3. History of other malignant tumors within the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix after curative resection;\n4. Presence of central nervous system (CNS) metastases or history of brain metastases prior to enrollment;\n5. Diagnosis of autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;\n6. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;\n7. Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as judged by the investigator);\n8. Severe cardiovascular diseases occurring within 6 months prior to the initiation of study treatment, including unstable angina pectoris or myocardial infarction; cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting (CABG) within 6 months prior to enrollment; congestive heart failure (CHF) with New York Heart Association (NYHA) classification \\> Grade 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) \\< 50%;\n9. Subjects with known hypersensitivity to the study drugs or any of their excipients;\n10. Participation in other clinical trials of unapproved or unmarketed drugs in China and receipt of the corresponding investigational drug treatment within 4 weeks prior to enrollment;\n11. International Normalized Ratio (INR) \\> 1.5 or activated partial thromboplastin time (APTT) \\> 1.5 × upper limit of normal (ULN);\n12. Electrolyte abnormalities deemed clinically significant by the investigator;\n13. Uncontrolled hypertension (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg) that cannot be controlled with medications prior to enrollment;\n14. Poorly controlled diabetes mellitus prior to enrollment (fasting blood glucose concentration ≥ Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade 2 after standard treatment);\n15. Any disease or condition that may affect drug absorption prior to enrollment, or inability to take fruquintinib orally;\n16. Active peptic ulcers of the stomach and duodenum, ulcerative colitis, or other gastrointestinal diseases; active bleeding from unresected tumors; or other conditions judged by the investigator to potentially cause gastrointestinal bleeding or perforation prior to enrollment;\n17. Active or uncontrolled severe infections (≥ CTCAE v5.0 Grade 2 infections);\n18. Known human immunodeficiency virus (HIV) infection; known history of clinically significant liver disease, including viral hepatitis \\[subjects known to be hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, i.e., HBV DNA positive (\\> 1 × 10⁴ copies/mL or \\> 2000 IU/mL); known hepatitis C virus (HCV) infection with positive HCV RNA (\\> 1 × 10³ copies/mL)\\];\n19. Unresolved toxicities above CTCAE v5.0 Grade 1 resulting from any prior anticancer treatment, excluding alopecia, lymphopenia, and ≤ Grade 2 neurotoxicity caused by oxaliplatin;\n20. Pregnant females (positive pregnancy test prior to drug administration) or females who are breastfeeding;\n21. Receipt of blood transfusion, blood products, or hematopoietic factors (e.g., albumin, granulocyte colony-stimulating factor \\[G-CSF\\]) within 14 days prior to enrollment;\n22. Any other diseases, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities; conditions judged by the investigator to make the subject unsuitable for study drug administration (e.g., epilepsy requiring treatment), potentially interfere with the interpretation of study results, or place the subject at high risk;\n23. Urinalysis indicating urinary protein ≥ 2+ and 24-hour urinary protein excretion \\> 1.0 g;\n24. Complications requiring long-term immunosuppressive therapy, or systemic or local use of immunosuppressive corticosteroids (\\> 10 mg/day prednisone or equivalent therapeutic hormones);\n25. Subjects deemed unsuitable for enrollment in this study by the investigator.","locations":[{"facility":"Union Hospital","city":"Wuhan","state":"Hubei","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hongli Liu","phone":"+86-027-85871962","email":"whxhzjy@hust.edu.cn"}],"primaryOutcomes":["Objective Response Rate (ORR)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["wuhan-china"],"enrichment":{"headline":"Phase 2: testing candonilimab combined with fruquintinib and paclitaxel albumin-bound for Stomach Neoplasms","inPlainEnglish":"This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","whoItsFor":["Ages 18 Years to 75 Years","Aged 18 to 75 years (inclusive);","Pathologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma;","Prior failure of first-line standard chemotherapy;","HER2-negative status;","how well you can do daily activities (ECOG score) of 0 to 2;","Expected survival of ≥3 months;","Presence of at least one measurable lesion, defined as:"],"whoShouldSkip":["Patients will be excluded from this study if they meet any of the following criteria:","Inability to comply with the study protocol or study procedures;","Prior treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors or prior use of immune checkpoint inhibitors;","History of other malignant tumors within the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix after curative resection;","Presence of central nervous system (CNS) metastases or history of brain metastases prior to enrollment;","Diagnosis of autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;","Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation;"],"whatHappens":"If you join, the listed intervention(s) are candonilimab combined with fruquintinib and paclitaxel albumin-bound. The registry lists allocation as na. This is a Phase II Study of Candonilimab Combined with Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 59 people at Wuhan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.979Z"},{"nctId":"NCT07920302","title":"Affective Cognitive Training in Mood Disorders and High-risk Relatives","officialTitle":"Brain Marker for Affective Cognitive Enhancement Following Targeted Training in Patients With Mood Disorders and High-risk Relatives: A Randomized Controlled Trial (BACE)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital","sponsorClass":"OTHER","summary":"The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives.\n\nThe investigators hypothesize that targeted affective cognitive training, compared with treatment as usual, will improve affective cognition (primary outcome), assessed using a composite measure of emotion regulation and facial emotion recognition.\n\nSecondly, the investigators hypothesize that the training will improve self-reported emotion regulation abilities and associated neural activity during emotion regulation, including changes in dorsolateral prefrontal cortex activity.\n\nFinally, the investigators will explore whether the training affects broader cognitive functioning, psychosocial functioning, quality of life, and longer-term clinical outcomes, including relapse or onset of mood disorder.","conditions":["Major Depressive Disorder (MDD)","Bipolar Disorder (BD)"],"keywords":["Affective cognition"],"interventions":[{"type":"BEHAVIORAL","name":"Targeted affective cognitive training"}],"enrollment":100,"startDate":"2025-11-17","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Confirmed ICD-10 diagnosis of BD or previous UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14)\n* Self-reported difficulties with emotion regulation (measured with Difficulties in Emotion Regulation Scale DERS: total score or at least two subscores ≥ 1 SD above expected norms)\n* Fluency in Danish language\n\nExclusion Criteria:\n\n* Diagnosis of schizophrenia\n* Autism spectrum disorder\n* Neurological disorder\n* Alcohol or substance abuse\n* Previous severe head trauma\n* Pregnancy\n* Claustrophobia\n* Pacemaker or other metal implants\n* Daily use of benzodiazepines \\> 22.5 mg. oxazepam or \\> 7.5 mg. diazepam per day\n* Received electroconvulsive therapy \\< 3 months prior to participation","locations":[{"facility":"Neurocognition and Emotion Across Disorders Brain Centre (NEAD)","city":"Frederiksberg","state":"Capital Region of Denmark","country":"Denmark","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Astrid Endrup Iversen, PhD student","phone":"+4520461323","email":"astrid.endrup.iversen@regionh.dk"},{"name":"Hanne Lie Kjærstad, PhD, senior researcher","phone":"","email":"hanne.lie.kjaerstad@regionh.dk"}],"primaryOutcomes":["Affective cognitive composite measure"],"hasResults":false,"conditionSlugs":["depression","bipolar-disorder"],"drugSlugs":[],"locationSlugs":["frederiksberg-denmark"],"enrichment":{"headline":"Not a traditional drug phase: Targeted affective cognitive training for Major Depressive Disorder (MDD)","inPlainEnglish":"The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives. The investigators hypothesize that targeted affective cognitive training, compared with treatment as usual, will improve affective cognition (primary outcome), assessed using a composite measure of emotion regulation and facial emotion recognition.","whoItsFor":["Ages 18 Years to 60 Years","Confirmed ICD-10 diagnosis of BD or previous UD in partial, or full remission (Hamilton Depression Rating Scale-17 items and Young Mania Rating Scale scores ≤14)","Self-reported difficulties with emotion regulation (measured with Difficulties in Emotion Regulation Scale DERS: total score or at least two subscores ≥ 1 SD above expected norms)","Fluency in Danish language"],"whoShouldSkip":["Diagnosis of schizophrenia","Autism spectrum disorder","Neurological disorder","Alcohol or substance abuse","Previous severe head trauma","Pacemaker or other metal implants","Daily use of benzodiazepines \\> 22.5 mg. oxazepam or \\> 7.5 mg. diazepam per day"],"whatHappens":"If you join, the listed intervention(s) are Targeted affective cognitive training. The registry lists allocation as randomized. The aim of this clinical trial is to investigate the effects of a six-week targeted affective cognitive training, combining virtual reality and computer-based exercises, in symptomatically stable patients with mood disorders (major depressive disorder or bipolar disorder) and unaffected first-degree relatives.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Frederiksberg. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.111Z"},{"nctId":"NCT07920744","title":"The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis","officialTitle":"The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fifth Affiliated Hospital, Sun Yat-Sen University","sponsorClass":"OTHER","summary":"This retrospective cross-sectional diagnostic study compared the diagnostic performance of ultrasound-measured spleen thickness (ST) and spleen diameter (SD) against esophagogastroduodenoscopy (EGD) for gastroesophageal varices (GOV) and high-risk varices (HRV) detection in patients with compensated cirrhosis.\n\nThe authors, including senior physicians in infectious diseases and ultrasound, reviewed the medical records and the following data were recorded on a case report form: participants' demographic, etiologic, and laboratory data; SD, ST, portal vein diameter (PVD) and spleen vein diameter (SVD) values; liver stiffness measurement (LSM), spleen stiffness measurement (SSM) by transient elastography (TE); and EGD results.","conditions":["Liver Cirrhosis","Gastroesophageal Varices"],"keywords":["spleen size","esophageal and gastric varices","compensated cirrhosis","non-invasive diagnostic model","machine learning"],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"spleen diameter"},{"type":"DIAGNOSTIC_TEST","name":"spleen thickness"},{"type":"DIAGNOSTIC_TEST","name":"esophagogastroduodenoscopy (EGD)"}],"enrollment":364,"startDate":"2026-10-28","completionDate":"2026-10-28","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age ≥18 years;\n2. compensated cirrhosis;\n\nExclusion Criteria:\n\n1. history of hepatic decompensation, such as ascites, EVB, and hepatic encephalopathy;\n2. non-cirrhotic portal hypertension;\n3. digestive system malignancies such as hepatocellular carcinoma, pancreatic carcinoma, or other malignant tumors infiltrating the digestive system;\n4. acute liver disease, or serum total bilirubin ≥ 100 μmol/L;\n5. history of splenectomy;\n6. acute or chronic portal vein thrombosis;\n7. pregnancy;\n8. concomitant HIV infection;\n9. prior TIPS, endoscopic variceal ligation (EVL), or endoscopic injection sclerotherapy (EIS);\n10. receipt of non-selective beta-blockers (NSBBs) or diuretics within 3 months before EGD or abdominal ultrasonography;\n11. persistent drug abuse other than alcohol;\n12. an interval of more than 6 months between abdominal ultrasonography and EGD, or the absence of results from either examination.","locations":[{"facility":"the Fifth Affiliated Hospital, Sun Yat-sen University","city":"Zhuhai","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xi Liu","phone":"15992670630","email":"liuxi26@mail.sysu.edu.cn"}],"primaryOutcomes":["Gastroesophageal Varices","high-risk varices"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["zhuhai-china"],"enrichment":{"headline":"Not a traditional drug phase: spleen diameter for Liver Cirrhosis","inPlainEnglish":"This retrospective cross-sectional diagnostic study compared the diagnostic performance of ultrasound-measured spleen thickness (ST) and spleen diameter (SD) against esophagogastroduodenoscopy (EGD) for gastroesophageal varices (GOV) and high-risk varices (HRV) detection in patients with compensated cirrhosis. The authors, including senior physicians in infectious diseases and ultrasound, reviewed the medical records and the following data were recorded on a case report form: participants' demographic, etiologic, and laboratory data; SD, ST, portal vein diameter (PVD) and spleen vein diameter (SVD) values; liver stiffness measurement (LSM), spleen stiffness measurement (SSM) by transient elastography (TE); and EGD results.","whoItsFor":["Ages 18 Years to any","compensated cirrhosis;"],"whoShouldSkip":["history of hepatic decompensation, such as ascites, EVB, and hepatic encephalopathy;","non-cirrhotic portal hypertension;","digestive system malignancies such as hepatocellular carcinoma, pancreatic carcinoma, or other malignant tumors infiltrating the digestive system;","acute liver disease, or serum total bilirubin ≥ 100 μmol/L;","history of splenectomy;","acute or chronic portal vein thrombosis;","concomitant HIV infection;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 364 people at Zhuhai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.038Z"},{"nctId":"NCT07920770","title":"Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer","officialTitle":"A Prospective Observational Study of Tumour Microenvironment Remodelling During Neoadjuvant Therapy in Locally Advanced Rectal Cancer Using Single-Cell and Spatial Multi-omics","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fujian Medical University Union Hospital","sponsorClass":"OTHER","summary":"This prospective observational study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses. The study examines how immune and stromal states change during treatment and how they relate to major pathological response.","conditions":["Rectal Neoplasms"],"keywords":["rectal cancer","neoadjuvant therapy","single-cell RNA sequencing","spatial transcriptomics","tumour immune microenvironment","pathological complete response"],"interventions":[],"enrollment":100,"startDate":"2025-01-01","completionDate":"2028-12-31","sex":"ALL","minAge":null,"maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 to 75 years\n* Eastern Cooperative Oncology Group performance status 0-1\n* Histologically confirmed rectal adenocarcinoma\n* Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)\n* Lower border of the tumour within 10 cm of the anal verge\n* Scheduled to receive neoadjuvant therapy followed by surgery, with tumour tissue and peripheral blood available before and during neoadjuvant therapy\n* Written informed consent for fresh biopsy or surgical tissue, or a waiver granted by the institutional ethics committee for archival specimens\n\nExclusion Criteria:\n\n* Insufficient tissue or nucleic acid quality for the planned profiling assays\n* Incomplete clinical records precluding assessment of pathological or clinical response\n* A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma","locations":[{"facility":"Fujian Medical University Union Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Wan-cai Que","phone":"0086-0591-86218304","email":"xhyyjgb@163.com"}],"primaryOutcomes":["Change in immune and stromal cell composition in tumour tissue during neoadjuvant therapy","Major pathological response (mPR) and its association with immune microenvironment features"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["fuzhou-china"],"enrichment":{"headline":"Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) study characterises the tumour immune microenvironment and microbial ecology of locally advanced rectal cancer before and during neoadjuvant therapy. Tumour tissue and peripheral blood are profiled by whole-genome sequencing, single-cell RNA sequencing with paired T-cell and B-cell receptor repertoire sequencing, spatial transcriptomics of formalin-fixed paraffin-embedded sections, multiplex immunofluorescence, and blood-based proteomic, cytokine and bulk T-cell receptor analyses.","whoItsFor":["Eastern Cooperative Oncology Group performance status 0-1","Histologically confirmed rectal adenocarcinoma","Locally advanced disease staged as cT3-T4N0 or cT2-T4N+ without distant metastasis (AJCC 8th edition)","Lower border of the tumour within 10 cm of the anal verge","Scheduled to receive neoadjuvant therapy followed by surgery, with tumour tissue and peripheral blood available before and during neoadjuvant therapy"],"whoShouldSkip":["Insufficient tissue or nucleic acid quality for the planned profiling assays","Incomplete clinical records precluding assessment of pathological or clinical response","A history of other malignancy within 5 years other than adequately treated carcinoma in situ or basal cell carcinoma"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Fuzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.078Z"},{"nctId":"NCT07920861","title":"A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose","officialTitle":"A Study of HB0017 Injection to Investigate PK After Subcutaneous Administration at Different Injection Sites in Healthy Volunteers, and to Evaluate Its Safety, Tolerability, and Pharmacokinetics in Low-body-weight Healthy Subjects","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Huabo Biopharm Co., Ltd.","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to (PART 1) to evaluate the safety and tolerability of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.","conditions":["Psoriasis","Ankylosing Spondylitis"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"HB0017 Injection"},{"type":"OTHER","name":"HB0017 Placebo"}],"enrollment":90,"startDate":"2026-01-19","completionDate":"2026-12-31","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\n* PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and BMI within 18\\~30（kg/m2）(including margin).\n* Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.\n* Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs.\n\nExclusion Criteria:\n\n* Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;\n* History of psychiatric disorders.\n* At screening, positive for any of the following in virological testing: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis test.\n* At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis.\n* Prior expose to anti-IL-17 or anti-IL-17 receptor antibody.\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention.\n* Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;\n* Subjects deemed unsuitable for participation in this clinical trial by the investigator.","locations":[{"facility":"First People's Hospital of Hangzhou","city":"Hangzhou","state":"Zhejiang","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ying Wang, PhD","phone":"086-18367124548","email":"nancywangying@163.com"}],"primaryOutcomes":["Adverse events","Cmax","AUCinf"],"hasResults":false,"conditionSlugs":["psoriasis"],"drugSlugs":[],"locationSlugs":["hangzhou-china"],"enrichment":{"headline":"Phase 1: testing HB0017 Injection for Psoriasis","inPlainEnglish":"The goal of this clinical trial is to (PART 1) to measure the whether it is safe and how hard side effects are to live with of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.","whoItsFor":["Ages 18 Years to 55 Years","Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures","PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and body-mass index (BMI) within 18\\~30（kg/m2）(including margin)","Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests","Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs"],"whoShouldSkip":["Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;","History of psychiatric disorders","At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis","Prior expose to anti-IL-17 or anti-IL-17 receptor antibody","Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention","Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;","Subjects deemed unsuitable for participation in this clinical trial by the investigator"],"whatHappens":"If you join, the listed intervention(s) are HB0017 Injection, or HB0017 Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to (PART 1) to measure the whether it is safe and how hard side effects are to live with of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 90 people at Hangzhou. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.572Z"},{"nctId":"NCT07921329","title":"Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea","officialTitle":"Clinical Testing of a Physiological Signal Detection, Recognition and Feedback System for Obstructive Sleep Apnea: Home-Based Submental Transcutaneous Neuromuscular Electrical Stimulation With Nightly Ring-Type Monitoring","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"E-DA Hospital","sponsorClass":"OTHER","summary":"This single-arm pilot study evaluates the feasibility of nightly wearable monitoring with a ring-type sleep monitor during a 4-week home-based program of submental transcutaneous neuromuscular electrical stimulation in adults with obstructive sleep apnea, and describes changes in the ring-derived apnea-hypopnea index, sleep continuity, STOP-Bang score and upper-airway anatomy on CT before and after training.","conditions":["Obstructive Sleep Apnea"],"keywords":["neuromuscular electrical stimulation","wearable monitoring","apnea-hypopnea index","obstructive sleep apnea"],"interventions":[{"type":"DEVICE","name":"Submental transcutaneous neuromuscular electrical stimulation (RS-18)"},{"type":"DEVICE","name":"Ring-type sleep monitor (Belun Ring BLS-100)"}],"enrollment":50,"startDate":"2025-06-07","completionDate":"2028-01","sex":"ALL","minAge":"20 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 20 to 65 years\n* Obstructive sleep apnea diagnosed by a physician on polysomnography or an equivalent respiratory-event index test with AHI \\>= 5 events/h (mild 5-14.9, moderate 15-29.9, severe \\>= 30)\n\nExclusion Criteria:\n\n* AHI \\< 5 events/h\n* Pregnancy\n* Prior nasal CPAP therapy\n* Inflammation, rash, broken skin, swelling or infection at the stimulation site\n* Cardiac disease, pacemaker or other implanted electronic or metallic device\n* Allergic reaction to the device\n* Concurrent use of other wearable medical devices (e.g., insulin pump)\n* Cognitive impairment\n* Suspected or confirmed epilepsy\n* Central pain syndromes including headache","locations":[{"facility":"E-Da Hospital","city":"Kaohsiung City","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in Ring-Derived Apnea-Hypopnea Index (bAHI3)"],"hasResults":false,"conditionSlugs":["sleep-apnea"],"drugSlugs":[],"locationSlugs":["kaohsiung-city-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: Submental transcutaneous neuromuscular electrical stimulation (RS-18) for Obstructive Sleep Apnea","inPlainEnglish":"This single-arm pilot study evaluates the feasibility of nightly wearable monitoring with a ring-type sleep monitor during a 4-week home-based program of submental transcutaneous neuromuscular electrical stimulation in adults with obstructive sleep apnea, and describes changes in the ring-derived apnea-hypopnea index, sleep continuity, STOP-Bang score and upper-airway anatomy on CT before and after training.","whoItsFor":["Ages 20 Years to 65 Years","Adults aged 20 to 65 years","Obstructive sleep apnea diagnosed by a physician on polysomnography or an equivalent respiratory-event index test with AHI \\>= 5 events/h (mild 5-14.9, moderate 15-29.9, severe \\>= 30)"],"whoShouldSkip":["Prior nasal CPAP therapy","Inflammation, rash, broken skin, swelling or infection at the stimulation site","Cardiac disease, pacemaker or other implanted electronic or metallic device","Allergic reaction to the device","Concurrent use of other wearable medical devices (e.g., insulin pump)","Cognitive impairment","Suspected or confirmed epilepsy"],"whatHappens":"If you join, the listed intervention(s) are Submental transcutaneous neuromuscular electrical stimulation (RS-18), or Ring-type sleep monitor (Belun Ring BLS-100). The registry lists allocation as na. This single-arm pilot study evaluates the feasibility of nightly wearable monitoring with a ring-type sleep monitor during a 4-week home-based program of submental transcutaneous neuromuscular electrical stimulation in adults with obstructive sleep apnea, and describes changes in the ring-derived apnea-hypopnea index, sleep continuity, STOP-Bang score and upper-airway anatomy on CT before and after training.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Kaohsiung City. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.939Z"},{"nctId":"NCT07921472","title":"Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide","officialTitle":"Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide During Pregnancy: The Retrospective Observational, Multi-site, BIKTAPREG Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","sponsorClass":"OTHER","summary":"Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide (TAF), the novel prodrug of tenofovir, another NRTI. This tablet (B/F/TAF) is a first-line treatment option recommended by most international guidelines for adults living with HIV. B/F/TAF is widely prescribed due to its high potency, excellent tolerability, and convenient once-daily dosing schedule.\n\nThe landscape of HIV management in pregnancy has undergone significant transformation since the mid-1990s. Guidelines for HIV screening during pregnancy, treatment of HIV-positive pregnant individuals, and the use of ARV drugs for prevention of perinatal (vertical) and postnatal HIV transmission have evolved substantially. Current guidelines recommend that pregnant women with HIV receive effective ARV therapy for maternal health and to avoid perinatal transmission; however, recommended treatment options differ in pregnancy due to concerns of toxicity, lower drug exposures, teratogenicity, or lack of information. Recently, pharmacokinetic, efficacy, and teratogenicity data have become available for B/F/TAF when used in pregnancy, and demonstrate consistently that while PK concentrations are lower, viral suppression (VS) is not affected. In response, some guidelines now list B/F/TAF as an alternative regimen to be used in pregnancy but recognize that data are still limited to make this a preferred regimen. French guidelines however, take a more conservative approach, listing BIC among drugs to avoid during pregnancy due to insufficient safety data.\n\nResearch question and objectives This retrospective multicentric, multinational observational cohort study is conducted in two distinct parts to evaluate B/F/TAF use in pregnant women with HIV-1.\n\nPart 1: Aims to describe the patterns of B/F/TAF use in women with HIV-1 who received B/F/TAF for at least 30 days at any point during pregnancy. This will be a descriptive analysis of initiation and switch patterns among those exposed to B/F/TAF during pregnancy, and demographics/immunological/clinical characteristics. The reasons for switching B/F/TAF to other ARV treatments during pregnancy will be explored.\n\nPart 2: Aims to describe viral, pregnancy and neonatal outcomes in a subset of women already on B/F/TAF treatment at conception with VS at the first trimester of pregnancy, and among those who continued to receive B/F/TAF through delivery, or switched to another regimen.","conditions":["HIV (Human Immunodeficiency Virus)","Pregnancy"],"keywords":["BIKTAPREG Study"],"interventions":[],"enrollment":300,"startDate":"2026-05-19","completionDate":"2026-11-30","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nPart 1:\n\n1. Women aged ≥18 years with documented HIV-1 infection\n2. Having at least one documented pregnancy during the study period\n3. Pregnancies with estimated conception date between January 1st 2018 and March 1st 2024\n4. Having received B/F/TAF for ≥30 days during pregnancy\n5. Having received HIV care at participating sites\n\n   Part 2:\n6. Receiving B/F/TAF before conception\n7. Demonstrated VS in first trimester (≥ 1 result of HIV-1 plasma viral load \\<50 copies/ml and no result ≥50 after achieving VS available before 14 weeks gestation)\n\nExclusion Criteria:\n\n1. Women who do not consent to having their data collected for research purposes\n2. Receiving B/F/TAF with other ARVs simultaneously","locations":[{"facility":"Hôpital Pitié-Slapêtrière","city":"Paris","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pierre Frange, Professor","phone":"+33 0144494961","email":"pierre.frange@aphp.fr"},{"name":"Valérie Pourcher, Professor","phone":"+33 1 42 16 02 62","email":"valerie.martinez@aphp.fr"}],"primaryOutcomes":["Proportion of women already on B/F/TAF treatment at conception","Proportion of women who started B/F/TAF as their first ARV regimen during pregnancy","Proportion of women who switched-off of B/F/TAF during pregnancy","Proportion of women who switched from other regimens to B/F/TAF during pregnancy","Proportion of women who were on B/F/TAF at time of delivery","Proportion of women who switched off B/F/TAF to another ARV regimen during pregnancy","Distribution of subsequent ARV regimens among women who switched from B/F/TAF to another ARV regimen during pregnancy"],"hasResults":false,"conditionSlugs":["als","hiv"],"drugSlugs":[],"locationSlugs":["paris-france"],"enrichment":{"headline":"Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide","inPlainEnglish":"Biktarvy® is a widely prescribed antiretroviral (ARV) medication used for the treatment of HIV-1, formulated as a single-tablet regimen. This combination therapy consists of three potent antiretroviral drugs: bictegravir (BIC/B), an integrase strand transfer inhibitor (INSTI); emtricitabine (FTC/F), a nucleoside reverse transcriptase inhibitor (NRTI); and tenofovir alafenamide (TAF), the novel prodrug of tenofovir, another NRTI.","whoItsFor":["Ages 18 Years to any","Women only","Women aged ≥18 years with documented HIV-1 infection","Having at least one documented pregnancy during the study period","Pregnancies with estimated conception date between January 1st 2018 and March 1st 2024","Having received B/F/TAF for ≥30 days during pregnancy","Having received HIV care at participating sites","Receiving B/F/TAF before conception","Demonstrated VS in first trimester (≥ 1 result of HIV-1 plasma viral load \\<50 copies/ml and no result ≥50 after achieving VS available before 14 weeks gestation)"],"whoShouldSkip":["Women who do not consent to having their data collected for research purposes","Receiving B/F/TAF with other ARVs simultaneously"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Paris. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:19.530Z"},{"nctId":"NCT07922018","title":"AI-assisted Home-based Intervention for ADHD Children","officialTitle":"Generative Artificial Intelligence Assisted Home-based Intervention for Attention Deficient Hyperactivity Disorder (ADHD) Children","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"National Taiwan University Hospital","sponsorClass":"OTHER","summary":"The goal of this clinical trial is to evaluate the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are:\n\nDoes the online diary platform training enhance children's emotion regulation and its connection to positive thinking? Does the online diary platform training provide an immediate, interactive, and effective emotion training tool during the wait for follow-up visits and treatment?\n\nResearchers will compare online diary platforms training to counselling to see if online diary platforms training enhance children's emotion regulation.\n\nParticipants will use the MangaChat diary platform to log their daily moods and events, which the platform transforms into comic strips to offer an engaging visual story of their emotional experiences. Participants are requested to use the platform daily (or at least 3 times per week) for approximately 10 to 15 minutes per session over a 12-week period.","conditions":["ADHD - Attention Deficit Disorder With Hyperactivity","ADHD - Combined Type","ADHD - Inattentive Type"],"keywords":["Generative artificial intelligence","Home-based intervention","Social emotional learing","Attention-deficit/hyperactivity disorder"],"interventions":[{"type":"DEVICE","name":"Generative artificial intelligence assisted diary platform home-based intervention"},{"type":"BEHAVIORAL","name":"Consultations and psychoeducation on child emotional management"}],"enrollment":120,"startDate":"2026-08-01","completionDate":"2027-07-31","sex":"ALL","minAge":"8 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Children aged 8-12 years with a professional diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), who are enrolled in the study only after obtaining informed consent from their parents or legal guardians, as well as the assent of the children themselves.\n\nExclusion Criteria:\n\n* Intellectual disability, defined as a Full Scale Intelligence Quotient (FSIQ) score of less than 70.\n\n  * Severe language or communication impairments.\n  * Lack of access to internet-connected devices.\n  * Inability to effectively use the platform for mood logging and self-reflection.","locations":[{"facility":"National Taiwan University Hospital Hsin-Chu Branch","city":"Hsinchu","state":"","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Pou-Leng Cheong, PhD","phone":"+886 972654171","email":"cheong.pouleng@gmail.com"}],"primaryOutcomes":["Conners CPT 3™ (The Conners Continuous Performance Test Third Edition™ )","SNAP-IV (Swanson, Nolan, and Pelham, Version IV)","BYI-II (Beck Youth Inventories Second Edition)","CBCL Ages 6-18 (Child Behavior Checklist for Ages 6-18)","PSI (Parenting Stress Index, 3rd edition)","Parental Satisfaction Questionnaire"],"hasResults":false,"conditionSlugs":["adhd"],"drugSlugs":[],"locationSlugs":["hsinchu-taiwan"],"enrichment":{"headline":"Not a traditional drug phase: Generative artificial intelligence assisted diary platform home-based intervention for ADHD - Attention Deficit Disorder With Hyperactivity","inPlainEnglish":"The goal of this clinical trial is to measure the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD). The main questions it aims to answer are: Does the online diary platform training enhance children's emotion regulation and its connection to positive thinking?","whoItsFor":["Ages 8 Years to 12 Years"],"whoShouldSkip":["Intellectual disability, defined as a Full Scale Intelligence Quotient (FSIQ) score of less than 70","Severe language or communication impairments","Lack of access to internet-connected devices","Inability to effectively use the platform for mood logging and self-reflection"],"whatHappens":"If you join, the listed intervention(s) are Generative artificial intelligence assisted diary platform home-based intervention, or Consultations and psychoeducation on child emotional management. The registry lists allocation as randomized. The goal of this clinical trial is to measure the effectiveness of online diary platforms for socio-emotional learning training in children with attention deficit hyperactivity disorder (ADHD).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Hsinchu. Taking part typically means using or being fitted with a device, following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.642Z"},{"nctId":"NCT07922252","title":"Micronutrient Supplementation and Chronotherapy in Children With ADHD","officialTitle":"A Randomized Controlled Trial Evaluating the Synergistic Effects of Broad-Spectrum Micronutrient Supplementation and Chronotherapy in Malaysian Children With ADHD","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"UCSI University","sponsorClass":"OTHER","summary":"Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children that can affect attention, behavior, learning, and daily functioning. Nutritional status, gut health, and sleep and circadian patterns may influence ADHD-related symptoms.\n\nThis randomized controlled trial will evaluate the effects of a 12-week intervention combining broad-spectrum multivitamin-mineral supplementation (Usanimals™) with chronotherapy-based lifestyle guidance in Malaysian children aged 6-12 years with ADHD. The intervention includes Usanimals™ supplementation and guidance on sleep routines and meal timing. Participants will be randomly allocated to either the intervention group or a control group receiving usual care.\n\nChanges in ADHD-related symptoms will be assessed using validated parent-reported measures, including the SNAP-IV and Conners questionnaires. Sleep patterns and gastrointestinal outcomes will also be evaluated. The study aims to determine whether this combined micronutrient and lifestyle approach may improve ADHD-related symptoms, sleep, and gastrointestinal outcomes compared with usual care.","conditions":["Attention Deficit Hyperactivity Disorder (ADHD)"],"keywords":["ADHD, micronutrient supplementation, omega-3 fatty acids, probiotics, chronotherapy, pediatric nutrition"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Broad-spectrum multivitamin and mineral supplementation"},{"type":"BEHAVIORAL","name":"Chronotherapy-Based Lifestyle Guidance"}],"enrollment":120,"startDate":"2027-01-01","completionDate":"2027-12-31","sex":"ALL","minAge":"6 Years","maxAge":"12 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion criteria:\n\n1. Children who meet the diagnostic criteria for attention-deficit/hyperactivity disorder (ADHD) or children with elevated parent-reported ADHD symptoms who meet at least one of the prespecified CPRS-48 or parent SNAP-IV screening thresholds at Week 0, as described in Screening and Eligibility. Children with parent-reported ASD Level 1 may also be included, provided they meet all ADHD screening and other eligibility criteria.\n2. Aged 6-12 years.\n3. Able to comply with the study procedures, medication schedule, and follow-up visits.\n4. Written informed consent has been obtained from the parent or legal guardian.\n\nExclusion criteria:\n\n1. Children with Autism Spectrum Disorder (ASD) Level 2 or Level 3, or with an ASD diagnosis of unknown severity that cannot be confirmed as Level 1 based on existing information.\n2. A diagnosed intellectual disability or an intelligence quotient (IQ) below 70.\n3. Presence of cardiac disease or liver disease.\n4. Participation in another clinical trial within the specified washout period.\n5. Presence of a diagnosed bleeding disorder or significant history of abnormal bleeding.\n6. Presence of any known or suspected immunocompromising condition.\n7. Any medical condition (e.g., severe allergies to fish/seafood or acute systemic diseases) or behavioral condition (e.g., acute psychiatric crises) that would compromise the participant's safety or the integrity of the study data.","locations":[{"facility":"UCSI University","city":"Kuala Lumpur","state":"Kuala Lumpur","country":"Malaysia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Shu Ly Lim, PhD","phone":"+60108926366","email":"shuly.olab@gmail.com"}],"primaryOutcomes":["Change in ADHD Symptoms Assessed by the Conners Parent Rating Scale","Change in ADHD Symptoms Assessed by the SNAP-IV Parent Rating Scale"],"hasResults":false,"conditionSlugs":["als","adhd"],"drugSlugs":[],"locationSlugs":["kuala-lumpur-malaysia"],"enrichment":{"headline":"Not a traditional drug phase: Broad-spectrum multivitamin and mineral supplementation for Attention Deficit Hyperactivity Disorder (ADHD)","inPlainEnglish":"Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children that can affect attention, behavior, learning, and daily functioning. Nutritional status, gut health, and sleep and circadian patterns may influence ADHD-related symptoms.","whoItsFor":["Ages 6 Years to 12 Years","Able to comply with the study procedures, medication schedule, and follow-up visits"],"whoShouldSkip":["Children with Autism Spectrum Disorder (ASD) Level 2 or Level 3, or with an ASD diagnosis of unknown severity that cannot be confirmed as Level 1 based on existing information","A diagnosed intellectual disability or an intelligence quotient (IQ) below 70","Presence of cardiac disease or liver disease","Participation in another clinical trial within the specified washout period","Presence of a diagnosed bleeding disorder or significant history of abnormal bleeding","Presence of any known or suspected immunocompromising condition","Any medical condition (e.g., severe allergies to fish/seafood or acute systemic diseases) or behavioral condition (e.g., acute psychiatric crises) that would compromise the participant's safety or the integrity of the study data"],"whatHappens":"If you join, the listed intervention(s) are Broad-spectrum multivitamin and mineral supplementation, or Chronotherapy-Based Lifestyle Guidance. The registry lists allocation as randomized. Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental condition in children that can affect attention, behavior, learning, and daily functioning.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Kuala Lumpur. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:14.642Z"},{"nctId":"NCT07922317","title":"ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window","officialTitle":"Evaluation of Clinical Outcomes Following Endovascular Thrombectomy for Acute Ischemic Stroke With Anterior Large Vessel Occlusion in Extended Time Window (24-72 Hours)","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"115 People's Hospital","sponsorClass":"OTHER_GOV","summary":"The ELATE study is a prospective, observational study designed to evaluate the clinical outcomes and safety profile of endovascular thrombectomy compared with best medical treatment alone in patients presenting with acute ischemic stroke due to anterior large vessel occlusion within 24 to 72 hours from stroke onset or last known well.","conditions":["Acute Ichemic Stroke"],"keywords":["Endovascular treatment","Large-vessel occlusion","Beyond 24-hour","Extended time window"],"interventions":[{"type":"PROCEDURE","name":"Endovascular treatment"}],"enrollment":284,"startDate":"2026-07-06","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Presentation with acute ischemic stroke within 24 to 72 hours of stroke onset or last known well.\n* Baseline NIHSS ≥ 8 (If patients have NIHSS \\< 8 at admission and experienced END to an NIHSS score ≥ 8 or higher, they also were included if they were 24 to 72 hours from the LKW at this point)\n* Clinical diagnosis of AIS due to anterior circulation LVO (internal carotid artery (ICA) extracranial or intracranial segment, middle cerebral artery (MCA) M1 and proximal M2 segment) on brain imaging (CTA/MRA).\n* Imaging criteria: must fulfill at least one:\n\n  * 1\\) Core-penumbra mismatch on CT perfusion (CTP) or MR perfusion (MRP) assessed: infarct core volume ≤ 70mL, mismatch ratio ≥ 1,8 and mismatch volume ≥ 15mL.\n  * 2\\) ASPECTS ≥6 on non-contrast CT or diffusion-weighted imaging (DWI).\n* Written informed consent (by patient or proxy, according to local requirements)\n\nExclusion Criteria:\n\n* Intracranial hemorrhage identified by CT or MRI\n* Pre-stroke modified Rankin Score (mRS) score of \\>2 (indicating previous disability)\n* Any terminal illness such that the patient has a life expectance of less than 1 year.\n* Patients with active cancer and undergoing treatment for cancer are excluded\n* Pregnancy","locations":[{"facility":"115 People'S Hospital","city":"Ho Chi Minh City","state":"Vietnam","country":"Vietnam","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hang Tran, M.D","phone":"+84778771795","email":"minhhangtran93@gmail.com"}],"primaryOutcomes":["Functional independence"],"hasResults":false,"conditionSlugs":["stroke"],"drugSlugs":[],"locationSlugs":["ho-chi-minh-city-vietnam"],"enrichment":{"headline":"Not a traditional drug phase: Endovascular treatment for Acute Ichemic Stroke","inPlainEnglish":"The ELATE study is a prospective, watch-and-measure (no experimental treatment required) study designed to measure the clinical outcomes and safety profile of endovascular thrombectomy compared with best medical treatment alone in patients presenting with acute ischemic stroke due to anterior large vessel occlusion within 24 to 72 hours from stroke onset or last known well.","whoItsFor":["Ages 18 Years to any","Presentation with acute ischemic stroke within 24 to 72 hours of stroke onset or last known well","Baseline NIHSS ≥ 8 (If patients have NIHSS \\< 8 at admission and experienced END to an NIHSS score ≥ 8 or higher, they also were included if they were 24 to 72 hours from the LKW at this point)","Clinical diagnosis of AIS due to anterior circulation LVO (internal carotid artery (ICA) extracranial or intracranial segment, middle cerebral artery (MCA) M1 and proximal M2 segment) on brain imaging (CTA/MRA)","Imaging criteria: must fulfill at least one:","1\\) Core-penumbra mismatch on CT perfusion (CTP) or MR perfusion (MRP) assessed: infarct core volume ≤ 70mL, mismatch ratio ≥ 1,8 and mismatch volume ≥ 15mL","2\\) ASPECTS ≥6 on non-contrast CT or diffusion-weighted imaging (DWI)"],"whoShouldSkip":["Intracranial hemorrhage identified by CT or MRI","Pre-stroke modified Rankin Score (mRS) score of \\>2 (indicating previous disability)","Any terminal illness such that the patient has a life expectance of less than 1 year","Patients with active cancer and undergoing treatment for cancer are excluded"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 284 people at Ho Chi Minh City. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.226Z"},{"nctId":"NCT07922668","title":"Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis","officialTitle":"Sintomi Addominali e RosaceA: Studio Osservazionale Sull'Associazione Tra Sindrome Dell'Intestino Irritabile (IBS) e l'Asse Intestino-pelle","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","sponsorClass":"OTHER","summary":"To describe the prevalence of rosacea in a population of patients with IBS followed at a tertiary-level university medical center.","conditions":["IBS (Irritable Bowel Syndrome)","Rosacea"],"keywords":["IBS","gut-skin axis"],"interventions":[],"enrollment":300,"startDate":"2026-09-01","completionDate":"2026-12-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Evaluation at the Internal Medicine, Digestive Physiopathology, and Dermatology outpatient clinics of the IRCCS AOU Policlinico di Sant'Orsola in Bologna within the last 12 months.\n* Presence of a confirmed diagnosis of IBS and/or rosacea documented in the outpatient medical record.\n* Availability of clinical data essential for the analysis.\n\nExclusion Criteria:\n\n* Age \\<18 years.\n* Unable to confirm the presence of IBS and/or rosacea.\n* Insufficient clinical data for analysis.","locations":[{"facility":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","city":"Bologna","state":"Italy","country":"Italy","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Giovanni Barbara, MD","phone":"0512144103","email":"giovanni.barbara@unibo.it"}],"primaryOutcomes":["Percentage of patients diagnosed with rosacea among the patients diagnosed with IBS included in the study."],"hasResults":false,"conditionSlugs":["ibs"],"drugSlugs":[],"locationSlugs":["bologna-italy"],"enrichment":{"headline":"Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome …","inPlainEnglish":"To describe the prevalence of rosacea in a population of patients with IBS followed at a tertiary-level university medical center.","whoItsFor":["Ages 18 Years to any","Evaluation at the Internal Medicine, Digestive Physiopathology, and Dermatology outpatient clinics of the IRCCS AOU Policlinico di Sant'Orsola in Bologna within the last 12 months","Presence of a confirmed diagnosis of IBS and/or rosacea documented in the outpatient medical record","Availability of clinical data essential for the analysis"],"whoShouldSkip":["Unable to confirm the presence of IBS and/or rosacea","Insufficient clinical data for analysis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 300 people at Bologna. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:20.427Z"},{"nctId":"NCT07922759","title":"Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery","officialTitle":"Lidocaine and Neuroimmunomodulation: The Effect of Local Anesthetic Concentration in Head and Neck Cancer Resections","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Medical Centre Ljubljana","sponsorClass":"OTHER","summary":"This study aims to investigate whether different doses of locally infiltrated lidocaine affect inflammation, neurological biomarkers, and cognitive function in patients undergoing major head and neck cancer surgery.\n\nMajor head and neck cancer surgery can cause substantial physical stress, inflammation, and changes in cognitive function after surgery. Lidocaine is a commonly used local anesthetic that may also have anti-inflammatory and protective effects on the nervous system. However, little is known about whether the dose of lidocaine injected into the surgical area influences these responses.\n\nThis prospective, randomized pilot study will include 20 adult patients undergoing head and neck cancer resection followed by microvascular free-flap reconstruction at University Medical Centre Ljubljana, Slovenia.\n\nParticipants will be randomly assigned to receive either 150 mg or 300 mg of lidocaine infiltrated into the surgical area at the beginning of surgery. Both groups will receive the same total volume of infiltration solution and the same dose of adrenaline.\n\nBlood samples will be collected before surgery, six hours after surgical incision, and on postoperative days 1, 2, and 6 to measure inflammatory and neurological biomarkers. Cognitive function will be assessed before surgery, on postoperative day 6, and three months after surgery.\n\nThe study will explore whether the higher dose of lidocaine is associated with differences in inflammatory responses, neurological biomarkers, and postoperative cognitive function. The findings will help inform the design of larger future clinical studies.","conditions":["Head and Neck Cancer (H&N)"],"keywords":["Lidocaine","Local Anesthetic Infiltration","Head and Neck Cancer Surgery","Neuroimmunomodulation","Perioperative Inflammation","Neurological Biomarkers","Postoperative Cognitive Function","Microvascular Free-Flap Reconstruction"],"interventions":[{"type":"DRUG","name":"Lidocaine HCl 1%"}],"enrollment":20,"startDate":"2026-06-20","completionDate":"2028-06","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Patients scheduled for oncological resection of head and neck cancer followed by microvascular soft-tissue free-flap reconstruction.\n* Body mass index (BMI) \\< 30 kg/m².\n* No known hypersensitivity to amide-type local anesthetics or components of the infiltration solutions.\n* Ability and willingness to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Refusal to participate or inability to provide written informed consent.\n* Known hypersensitivity to lidocaine or any component of the infiltration solution.\n* Heart failure with a left ventricular ejection fraction \\< 50%.\n* Cardiac conduction disorders without an implanted pacemaker.\n* Uncontrolled epilepsy.\n* Hepatic or renal insufficiency.\n* Pregnancy or breastfeeding.\n* Pre-existing neurological diseases.\n* Psychiatric disorders.\n* Preoperative Mini-Mental State Examination (MMSE) score \\< 23 points.","locations":[{"facility":"University Medical Centre Ljubljana","city":"Ljubljana","state":"","country":"Slovenia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Liljana Markova, MD, PhD","phone":"+38640802662","email":"liljana.markova@kclj.si"},{"name":"Eleonora Ivanova, MD","phone":"+386 31 289 803","email":"eleonora.ivanova@kclj.si"}],"primaryOutcomes":["Change in Serum Interleukin-6 (IL-6) Concentration","Change in Serum Interleukin-8 (IL-8) Concentration","Change in Serum Interleukin-10 (IL-10) Concentration","Change in Serum Neuron-Specific Enolase (NSE) Concentration","Change in Serum S100 Beta (S100β) Protein Concentration","Change in Serum Glial Fibrillary Acidic Protein (GFAP) Concentration","Change in Serum Matrix Metalloproteinase-9 (MMP-9) Concentration"],"hasResults":false,"conditionSlugs":["head-and-neck-cancer","als"],"drugSlugs":[],"locationSlugs":["ljubljana-slovenia"],"enrichment":{"headline":"Phase 4: testing Lidocaine HCl 1% for Head and Neck Cancer (H&N)","inPlainEnglish":"This study aims to see if different doses of locally infiltrated lidocaine affect inflammation, neurological biomarkers, and cognitive function in patients undergoing major head and neck cancer surgery. Major head and neck cancer surgery can cause substantial physical stress, inflammation, and changes in cognitive function after surgery.","whoItsFor":["Ages 18 Years to any","Adult patients aged 18 years or older","Patients scheduled for oncological resection of head and neck cancer followed by microvascular soft-tissue free-flap reconstruction","Body mass index (body-mass index (BMI)) \\< 30 kg/m²","No known hypersensitivity to amide-type local anesthetics or components of the infiltration solutions"],"whoShouldSkip":["Known hypersensitivity to lidocaine or any component of the infiltration solution","Heart failure with a left ventricular ejection fraction \\< 50%","Cardiac conduction disorders without an implanted pacemaker","Uncontrolled epilepsy","Hepatic or renal insufficiency","Pregnancy or breastfeeding","Pre-existing neurological diseases"],"whatHappens":"If you join, the listed intervention(s) are Lidocaine HCl 1%. The registry lists allocation as randomized. This study aims to see if different doses of locally infiltrated lidocaine affect inflammation, neurological biomarkers, and cognitive function in patients undergoing major head and neck cancer surgery.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 20 people at Ljubljana. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.019Z"},{"nctId":"NCT07923097","title":"Study Designed to Evaluate the Safety, Tolerability, and PK of RAP-219 Formulated as an Long Acting Injectable.","officialTitle":"A Phase 1, Double-blind, Placebo-controlled, Single- and Multiple-dose Study of the Safety, Tolerability, and Pharmacokinetics of RAP-219 Administered as a Long-acting Injectable to Healthy Participants","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Rapport Therapeutics Inc.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1, double-blind, placebo-controlled, 5-cohort study evaluating the pharmacokinetics (PK), safety, and tolerability of RAP-219-LAI in healthy participants aged 18 to 65 years. Assessment of up to four single-dose cohorts will characterize the PK profile of up to four ascending dose levels and evaluate dose proportionality. One multiple-dose cohort will characterize the accumulation profile of RAP-219-LAI.\n\nThe study includes a Screening Period of up to 28 days (Day -28 to Day -1) for participants in all cohorts. Cohorts 1, 2, 3, and 4 will include admission on Day -1, a single dosing day (Day 1), a 28-day inpatient and outpatient Treatment Period (Day 1 to Day 28), and a 28-day Follow-up Period (Day 29 to Day 56). Cohort 5 will include admission on Day -1 and Day 28, two dosing days (Day 1 and Day 29), a 56-day inpatient and outpatient Treatment Period (Day 1 to Day 56), and a 28-day Follow-up Period (Day 57 to Day 84).\n\nUp to 60 participants are planned to be enrolled in this study, with 12 participants per cohort randomized in a 3:1 ratio to receive RAP-219-LAI or placebo.","conditions":["Epilepsy"],"keywords":[],"interventions":[{"type":"DRUG","name":"RAP-219 or Placebo"}],"enrollment":60,"startDate":"2026-11","completionDate":"2027-06","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n1. Able and willing to provide written informed consent to participate in the study and comply with all aspects of the protocol\n2. Age 18 to 65 years, inclusive, at Screening\n3. Medically healthy, with no current medical or psychiatric conditions, or those that the participant has been diagnosed with or received treatment for in the past 1 year, or clinically significant abnormalities, as determined by the PI or delegate based on the participant's medical history, physical examination, vital signs, ECG, and laboratory evaluations\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or intending to become pregnant during the course of the study\n2. Skin conditions affecting abdominal injection site or any condition or characteristic that may prevent assessment of injection site reactions (ISRs)\n3. Inadequate venous access or unsuitable veins for venipuncture\n4. Donated blood or experienced significant blood loss (greater than or equals to 450 millilitres) within 12 weeks, donated bone marrow or peripheral stem cells within 90 days, or donated plasma within 4 weeks prior to Day 1.\n5. History of malignancy, with the exception of non-melanoma skin cancer or cancer curatively treated greater than or equals to 5 years prior to Screening without evidence of recurrence\n6. Recent history or current substance abuse\n7. Consumption of liquids or foods containing Seville oranges, grapefruit, lime, pomegranate, or star fruit from 7 days prior to Day 1, or poppy seed from 3 days prior to Day 1 (all cohorts)\n8. Unable or unwilling to refrain from strenuous exercise from 3 days prior to Day 1 and during the inpatient periods through the end of the study\n9. History of any illness, any medical or psychiatric condition, or laboratory abnormality that, in the opinion of the PI or delegate, might prevent the participant from completing the study, pose a risk to the participant, or confound the results of the study\n10. Any non-negative serology results for hepatitis B surface antigen, hepatitis C antibody, or HIV antigen and antibody.\n11. Any surgical procedure within 3 months prior to Screening from which a full recovery was not made and/or with sequelae that may impact study procedures/outcomes and/or safety, as judged by the PI or delegate","locations":[{"facility":"CMAX Clinical Research","city":"Adelaide","state":"","country":"Australia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Rapport Medical","phone":"857 323 9048","email":"RAP-219-FOS@rapportrx.com"}],"primaryOutcomes":["Maximum Plasma Concentration (Cmax)"],"hasResults":false,"conditionSlugs":["epilepsy"],"drugSlugs":[],"locationSlugs":["adelaide-australia"],"enrichment":{"headline":"Phase 1: testing RAP-219 or Placebo for Epilepsy","inPlainEnglish":"This is a Phase 1, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 5-cohort study evaluating the pharmacokinetics (PK), safety, and tolerability of RAP-219-LAI in healthy participants aged 18 to 65 years. Assessment of up to four single-dose cohorts will characterize the PK profile of up to four ascending dose levels and evaluate dose proportionality.","whoItsFor":["Ages 18 Years to 65 Years","Age 18 to 65 years, inclusive, at Screening"],"whoShouldSkip":["Pregnant or breastfeeding, or intending to become pregnant during the course of the study","Skin conditions affecting abdominal injection site or any condition or characteristic that may prevent assessment of injection site reactions (ISRs)","Inadequate venous access or unsuitable veins for venipuncture","Donated blood or experienced significant blood loss (greater than or equals to 450 millilitres) within 12 weeks, donated bone marrow or peripheral stem cells within 90 days, or donated plasma within 4 weeks prior to Day 1","History of malignancy, with the exception of non-melanoma skin cancer or cancer curatively treated greater than or equals to 5 years prior to Screening without evidence of recurrence","Recent history or current substance abuse","Consumption of liquids or foods containing Seville oranges, grapefruit, lime, pomegranate, or star fruit from 7 days prior to Day 1, or poppy seed from 3 days prior to Day 1 (all cohorts)"],"whatHappens":"If you join, the listed intervention(s) are RAP-219 or Placebo. The registry lists allocation as randomized. This is a Phase 1, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment, 5-cohort study evaluating the pharmacokinetics (PK), safety, and tolerability of RAP-219-LAI in healthy participants aged 18 to 65 years.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 60 people at Adelaide. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.902Z"},{"nctId":"NCT07923214","title":"A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors","officialTitle":"A Phase I, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CG-7321 as Monotherapy or in Combination Therapy in Subjects With Advanced Solid Tumors","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SEQUENTIAL","masking":"NONE","sponsor":"Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a Phase I, open-label, multi-center study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of CG-7321 capsules as monotherapy or in combination with fulvestrant in subjects with advanced solid tumors.\n\nThe study consists of:\n\n* Part Ia (Monotherapy): Dose escalation (accelerated titration followed by 3+3 design) from 2mg to 50mg twice daily (BID), plus dose expansion cohorts in advanced solid tumors including HR+/HER2- breast cancer, ovarian cancer, gastric cancer, and other tumor types.\n* Part Ib (Combination Therapy): Dose escalation of CG-7321 combined with fulvestrant in HR+/HER2- advanced breast cancer.","conditions":["Advanced Solid Tumors","Breast Cancer","Ovarian Cancer","Gastric Cancer","Other Solid Tumors"],"keywords":["CDK inhibitor","Phase I","Dose escalation","Advanced solid tumors","Pharmacokinetics","Maximum tolerated dose"],"interventions":[{"type":"DRUG","name":"CG-7321"}],"enrollment":30,"startDate":"2024-07-02","completionDate":"2026-12","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* 1\\. Voluntary signed informed consent and compliance with protocol requirements\n* 2\\. Age ≥18 years, any gender\n* 3\\. Life expectancy ≥12 weeks\n* 4\\. Eastern Cooperative Oncology Group（ECOG） performance status 0-1\n* 5\\. For Ia monotherapy dose escalation: patients with cytologically and/or histopathologically confirmed advanced or metastatic solid tumors who have failed, are intolerant to, or have no effective standard treatment, or who refuse standard treatment\n* 6\\. Voluntary provision of tumor tissue specimens (archived within 2 years or fresh tissue)\n* 7\\. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1（RECIST 1.1）\n* 8\\. Prior anticancer treatment-related toxicities resolved to ≤1 grade (except alopecia)\n* 9\\. Adequate organ and bone marrow function\n* 10\\. Negative serum pregnancy test within 7 days before first dose\n* 11\\. Agreement to use effective contraception from ICF signing to ≥6 months after last dose\n* 12\\. No breastfeeding during study and ≥6 months after last dose\n* 13\\. Understanding of study and voluntary written informed consent\n\nExclusion Criteria:\n\n* 1\\. Anticancer therapy (chemotherapy, targeted therapy, biologics, immunotherapy, radiotherapy) within 4 weeks before first dose, or participation in other interventional clinical studies (observational studies excluded)\n* 2\\. Strong Cytochrome P450 3A4（CYP3A4）inhibitors within 2 weeks before first dose\n* 3\\. Strong Cytochrome P450 2C8（CYP2C8） inhibitors within 2 weeks before first dose\n* 4\\. Other active malignancies within 3 years before first dose (except curable tumors treated radically)\n* 5\\. Primary Central Nervous System（CNS） tumors or CNS metastases that failed local treatment (stable asymptomatic CNS metastases allowed)\n* 6\\. Conditions affecting drug absorption or Pharmacokinetics（PK） parameters (e.g., uncontrolled nausea/vomiting, chronic diarrhea, malabsorption syndrome)\n* 7\\. Uncontrolled or significant cardiovascular disease,\n* 8\\. Active infection requiring systemic therapy within 2 weeks;\n* 9\\. Major surgery within 4 weeks before first dose (except minor procedures)\n* 10\\. Known allergy to study drug or excipients\n* 11\\. Mental or cognitive impairment affecting study compliance\n* 12\\. Known alcohol or drug dependence\n* 13\\. Pregnant or lactating women\n* 14\\. Investigator deems subject unsuitable for study participation","locations":[{"facility":"Fujian Cancer Hospital","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Zhongshan Hospital of Dalian University","city":"Dalian","state":"Liaoning","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Fudan University Shanghai Cancer Center","city":"Shanghai","state":"Shanghai Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"West China Hospital, Sichuan University","city":"Chengdu","state":"Sichuan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ke Lan","phone":"+86-13982078904","email":"lanke@cynogen.com"}],"primaryOutcomes":["Dose-Limiting Toxicities (DLTs)","Maximum Tolerated Dose (MTD)","Recommended Phase 2 Dose (RP2D)","Adverse Events (AEs) and SAEs"],"hasResults":false,"conditionSlugs":["breast-cancer","ovarian-cancer","stomach-cancer"],"drugSlugs":[],"locationSlugs":["fuzhou-china","dalian-china","shanghai-china","chengdu-china"],"enrichment":{"headline":"Phase 1: testing CG-7321 for Advanced Solid Tumors","inPlainEnglish":"This is a Phase I, open-label, multi-center study to measure the safety, tolerability, pharmacokinetics (PK), and preliminary how well it works of CG-7321 capsules as this drug alone or in combination with fulvestrant in subjects with advanced solid tumors. The study consists of: * Part Ia (this drug alone): Dose escalation (accelerated titration followed by 3+3 design) from 2mg to 50mg twice daily (BID), plus dose expansion cohorts in advanced solid tumors including HR+/HER2- breast cancer, ovarian cancer, gastric cancer, and other tumor types.","whoItsFor":["Ages 18 Years to any","2\\. Age ≥18 years, any gender","3\\. Life expectancy ≥12 weeks","4\\. Eastern Cooperative Oncology Group（ECOG） performance status 0-1","5\\. For Ia this drug alone dose escalation: patients with cytologically and/or histopathologically confirmed advanced or metastatic solid tumors who have failed, are intolerant to, or have no effective standard treatment, or who refuse standard treatment","6\\. Voluntary provision of tumor tissue specimens (archived within 2 years or fresh tissue)","7\\. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1（RECIST 1.1）","8\\. Prior anticancer treatment-related toxicities resolved to ≤1 grade (except alopecia)"],"whoShouldSkip":["1\\. Anticancer therapy (chemotherapy, targeted therapy, biologics, immunotherapy, radiotherapy) within 4 weeks before first dose, or participation in other treatment clinical studies (watch-and-measure (no experimental treatment required) studies excluded)","2\\. Strong Cytochrome P450 3A4（CYP3A4）inhibitors within 2 weeks before first dose","3\\. Strong Cytochrome P450 2C8（CYP2C8） inhibitors within 2 weeks before first dose","4\\. Other active malignancies within 3 years before first dose (except curable tumors treated radically)","5\\. Primary Central Nervous System（CNS） tumors or CNS metastases that failed local treatment (stable asymptomatic CNS metastases allowed)","6\\. Conditions affecting drug absorption or Pharmacokinetics（PK） parameters (e.g., uncontrolled nausea/vomiting, chronic diarrhea, malabsorption syndrome)","7\\. Uncontrolled or significant cardiovascular disease,"],"whatHappens":"If you join, the listed intervention(s) are CG-7321. The registry lists allocation as randomized. This is a Phase I, open-label, multi-center study to measure the safety, tolerability, pharmacokinetics (PK), and preliminary how well it works of CG-7321 capsules as this drug alone or in combination with fulvestrant in subjects with advanced solid tumors.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 30 people at 4 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.171Z"},{"nctId":"NCT07923552","title":"Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS","officialTitle":"Proof-of-Concept Study Evaluating the Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS Requiring Surgical Treatment.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"University Hospital, Clermont-Ferrand","sponsorClass":"OTHER","summary":"Polycystic Ovary Syndrome (PCOS) is a common condition among young women (the leading endocrine disorder) and is responsible for 70% of anovulatory infertility cases. Clinically, it has been defined since 2003 by the Rotterdam criteria, according to the French College of Obstetricians and Gynecologists. PCOS represents a significant challenge in reproductive medicine, as it is associated with infertility rates ranging from 20% to 74%. Ovarian stimulation is the first-line treatment for PCOS, as no etiological treatment is available. The first-line pharmacological treatment is Clomiphene Citrate. In cases where Clomiphene Citrate fails, the second-line treatment is ovarian drilling. Traditionally, ovarian drilling was performed via laparoscopy or fertiloscopy. Fertiloscopy had the advantage of being quicker and scarless for patients, with reported failure and conversion rates to laparoscopy of 10% to 20% depending on the studies. However, fertiloscopy is no longer practiced due to the discontinuation of the device. With the advent of vNOTES laparoscopy (Vaginal Natural Orifice Transluminal Endoscopic Surgery) in the 2010s for benign gynecological conditions, the possibility of a new vaginal approach for ovarian drilling is now being considered. The Primary Objective is to Evaluate the efficacy of ovarian drilling via vNOTES laparoscopy in terms of resumption of spontaneous ovulatory cycles in PCOS patients requiring surgical treatment.\n\nStudy Type:\n\nSingle-center, randomized, controlled, two-arm, proof-of-concept study. Number of Centers: 1\n\nStudy Description:\n\nDuring the gynecology consultation, if an indication for ovarian drilling is established, the patient will be invited to participate in the study protocol. The study information sheet, detailing the study procedures and objectives, along with the consent form, will be provided to the patient.\n\nA second consultation with the investigator will be scheduled to address any questions following a reflection period. If the patient consents, both she and the investigator will sign the consent form.\n\nRandomization will be conducted using REDCap® software. The patient will then be assigned to either the vNOTES group or the laparoscopy group. Surgery will be performed by surgeons designated as \"experts\" in the respective surgical approach. The procedure will follow the standard techniques of the department.\n\nOvulatory cycle resumption will be assessed 6 months postoperatively during a follow-up consultation.","conditions":["PCOS (Polycystic Ovary Syndrome)"],"keywords":["PCOS","drilling","Vnotes","laparoscopy"],"interventions":[{"type":"PROCEDURE","name":"ovarian drilling by abdominal Laparoscopy"},{"type":"PROCEDURE","name":"Ovarian drilling by vaginal laparoscopy VNotes"}],"enrollment":48,"startDate":"2025-03-14","completionDate":"2030-09-14","sex":"FEMALE","minAge":"18 Years","maxAge":"43 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* PCOS defined by Rotterdam criteria requiring ovarian drilling after failure of first-line medical treatment\n* Primary or secondary infertility\n* Able to provide informed consent to participate in the research\n\nExclusion Criteria:\n\n* History of ovarian drilling\n* History of multiple pelvic surgeries\n* Current pregnancy or breastfeeding\n* Need for another associated surgical procedure other than hysteroscopy (hysteroscopy, neostomy)\n* Other infertility factors requiring IVF management\n* Contraindication to either surgical approach (laparoscopy or vNOTES):\n* History of upper genital tract infection\n* Confirmed or suspected recto-vaginal endometriosis on clinical examination\n* History of rectal surgery\n* Promontofixation\n* Virgin patient\n* Any concomitant pathology deemed incompatible with the study\n* Patients not affiliated with the social security system\n* Patients not speaking French\n* Patients under guardianship, curatorship, deprived of liberty, or under judicial protection\n* Refusal to participate","locations":[{"facility":"CHU Clermont-Ferrand","city":"Clermont-Ferrand","state":"","country":"France","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Lise Laclautre","phone":"+33473754963","email":"promo_interne_drci@chu-clermontferrand.fr"}],"primaryOutcomes":["The resumption (or not) of an ovulatory cycle"],"hasResults":false,"conditionSlugs":["pcos"],"drugSlugs":[],"locationSlugs":["clermont-ferrand-france"],"enrichment":{"headline":"Not a traditional drug phase: ovarian drilling by abdominal Laparoscopy for PCOS (Polycystic Ovary Syndrome)","inPlainEnglish":"Polycystic Ovary Syndrome (PCOS) is a common condition among young women (the leading endocrine disorder) and is responsible for 70% of anovulatory infertility cases. Clinically, it has been defined since 2003 by the Rotterdam criteria, according to the French College of Obstetricians and Gynecologists.","whoItsFor":["Ages 18 Years to 43 Years","Women only","PCOS defined by Rotterdam criteria requiring ovarian drilling after failure of first-line medical treatment","Primary or secondary infertility"],"whoShouldSkip":["History of ovarian drilling","History of multiple pelvic surgeries","Current pregnancy or breastfeeding","Need for another associated surgical procedure other than hysteroscopy (hysteroscopy, neostomy)","Other infertility factors requiring IVF management","Contraindication to either surgical approach (laparoscopy or vNOTES):","History of upper genital tract infection"],"whatHappens":"If you join, the listed intervention(s) are ovarian drilling by abdominal Laparoscopy, or Ovarian drilling by vaginal laparoscopy VNotes. The registry lists allocation as randomized. Polycystic Ovary Syndrome (PCOS) is a common condition among young women (the leading endocrine disorder) and is responsible for 70% of anovulatory infertility cases.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 48 people at Clermont-Ferrand. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.172Z"},{"nctId":"NCT07923682","title":"Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study","officialTitle":"Outcomes of Endoscopic Knife-Assisted Full-Thickness Resection for Rectal Lesions: An International Multicentre Retrospective Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"University Hospital, Ghent","sponsorClass":"OTHER","summary":"This study looks at the results of a new technique called knife-assisted full-thickness resection (kFTR) for removing rectal lesions. In kFTR, a doctor uses an electrical knife to remove a rectal growth along with the full thickness of the rectal wall. Current methods for removing early rectal tumors each have limits depending on the size and location of the growth. This study collects data from hospitals in multiple countries to find out how well kFTR works and how safe it is. Researchers review medical records and endoscopy reports from patients who already had kFTR at participating hospitals. The main measures are whether the procedure was completed successfully, whether the growth was removed in one piece, whether the edges were cancer-free, and how often complications occurred. The study also tracks hospital stay length, need for additional surgery, cancer recurrence, and death.","conditions":["Colorectal Cancer"],"keywords":["Colorectal Cancer","knife-assisted full-thickness resection","endoscopic resection","early rectal cancer","endoscopic submucosal dissection"],"interventions":[],"enrollment":150,"startDate":"2025-05-02","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 18 years and older\n* Knife-assisted full-thickness resection (kFTR) performed for a rectal lesion at a participating center\n\nExclusion Criteria:\n\n* Unavailable information regarding kFTR technical outcomes","locations":[{"facility":"University Hospital Ghent","city":"Ghent","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"David Tate","phone":"093321063","email":"studiestissue.resectie@uzgent.be"}],"primaryOutcomes":["Technical success rate","En-bloc resection rate","R0 resection rate","Rate of complications"],"hasResults":false,"conditionSlugs":["colorectal-cancer","als"],"drugSlugs":[],"locationSlugs":["ghent-belgium"],"enrichment":{"headline":"Outcomes of Knife-Assisted Full-Thickness Resection for Rectal Lesions: A Multicenter Study","inPlainEnglish":"This study looks at the results of a new technique called knife-assisted full-thickness resection (kFTR) for removing rectal lesions. In kFTR, a doctor uses an electrical knife to remove a rectal growth along with the full thickness of the rectal wall.","whoItsFor":["Ages 18 Years to any","Patients aged 18 years and older","Knife-assisted full-thickness resection (kFTR) performed for a rectal lesion at a participating center"],"whoShouldSkip":["Unavailable information regarding kFTR technical outcomes"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 150 people at Ghent. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.071Z"},{"nctId":"NCT07923812","title":"Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study","officialTitle":"Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fudan University","sponsorClass":"OTHER","summary":"The goal of this multicenter retrospective observational study is to learn about the real-world safety and clinical effectiveness of disease-modifying therapy (DMT) in adults with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or AD dementia. The main questions it aims to answer are:\n\nWhat are the safety outcomes of DMT, including amyloid-related imaging abnormalities (ARIA), adverse events, and infusion reactions (IRRs)? How do Clinical Dementia Rating (CDR) measures change in patients who receive DMT compared with those who do not?\n\nResearchers will compare patients who receive DMT as part of their routine clinical care with patients who do not receive DMT to evaluate differences in clinical outcomes and safety.\n\nParticipants will not receive any study-assigned intervention or additional treatment as part of this study. Researchers will retrospectively collect existing clinical data, including cognitive and neuropsychiatric assessments, imaging findings, biomarker results, DMT use, and safety information.","conditions":["Alzheimer's Disease (AD)"],"keywords":[],"interventions":[{"type":"DRUG","name":"Disease-Modifying Therapy"}],"enrollment":3000,"startDate":"2026-10-26","completionDate":"2027-06-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Disease-Modifying Therapy Group\n\n1. Patients with a baseline diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or dementia due to AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.\n2. Age ≥18 years at baseline.\n3. Patients who have received disease-modifying therapy (DMT).\n4. Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.\n5. Written or electronic informed consent provided by the patient when cognitive capacity permits, or by the patient's legally authorized representative or guardian.\n\nNon-Disease-Modifying Therapy Group\n\n1. Patients with a baseline diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or dementia due to AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria.\n2. Age ≥18 years at baseline.\n3. Patients who have not received disease-modifying therapy (DMT).\n4. Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers.\n5. Written or electronic informed consent provided by the patient when cognitive capacity permits, or by the patient's legally authorized representative or guardian.\n\nExclusion Criteria\n\n1. The patient, when cognitive capacity permits, explicitly refuses to provide informed consent, or the patient's legally authorized representative or guardian refuses to provide consent on the patient's behalf, either in written or electronic form.\n2. Amyloid-beta (Aβ) pathological evidence is missing or does not meet the study requirements.\n3. Presence of a major neurological disorder that may confound the assessment of cognitive outcomes.\n4. Previous treatment with other anti-amyloid monoclonal antibodies, or participation in an interventional clinical trial that may affect the assessment of study outcomes.\n5. Serious inconsistencies or errors in key participant information.","locations":[{"facility":"Huashan Hospital, Fudan University, No. 12 Wulumuqi Middle Road, Jing'an District, Shanghai","city":"Shanghai","state":"Jingan","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jintai Yu, MD","phone":"+86 21 52888163","email":"jintai_yu@fudan.edu.cn"}],"primaryOutcomes":["Safety of Disease-Modifying Therapy","Clinical Effectiveness of Disease-Modifying Therapy"],"hasResults":false,"conditionSlugs":["alzheimer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Disease-Modifying Therapy for Alzheimer's Disease (AD)","inPlainEnglish":"The goal of this multicenter retrospective watch-and-measure (no experimental treatment required) study is to learn about the real-world safety and clinical effectiveness of disease-modifying therapy (DMT) in adults with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or AD dementia. The main questions it aims to answer are: What are the safety outcomes of DMT, including amyloid-related imaging abnormalities (ARIA), side effects, and infusion reactions (IRRs)?","whoItsFor":["Ages 18 Years to any","Disease-Modifying Therapy Group","Patients with a baseline diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or dementia due to AD according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) diagnostic criteria","Age ≥18 years at baseline","Patients who have received disease-modifying therapy (DMT)","Alzheimer's disease-related amyloid pathology confirmed or supported by amyloid positron emission tomography (PET), cerebrospinal fluid (CSF) biomarkers, or blood biomarkers","Non-Disease-Modifying Therapy Group","Patients who have not received disease-modifying therapy (DMT)"],"whoShouldSkip":["Amyloid-beta (Aβ) pathological evidence is missing or does not meet the study requirements","Presence of a major neurological disorder that may confound the assessment of cognitive outcomes","Previous treatment with other anti-amyloid monoclonal antibodies, or participation in an treatment clinical trial that may affect the assessment of study outcomes","Serious inconsistencies or errors in key participant information"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,000 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.326Z"},{"nctId":"NCT07923825","title":"Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea","officialTitle":"A Prospective Observational Study to Develop and Validate a Multimodal Deep Learning Model Integrating Peripheral Oxygen Saturation and Ballistocardiography Signals for the Prediction of Apnea-Hypopnea Index in Patients With Suspected Obstructive Sleep Apnea","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Fu Jen Catholic University","sponsorClass":"OTHER","summary":"Obstructive sleep apnea (OSA) is a common sleep disorder associated with cardiovascular, metabolic, and neurocognitive complications. The standard diagnostic test for OSA is in-laboratory polysomnography (PSG), which can be costly, labor-intensive, and inconvenient for repeated or large-scale screening. Therefore, there is a need for a convenient and non-invasive method to help identify individuals who may be at risk for OSA.\n\nThis prospective observational study aims to develop and clinically validate a multimodal deep learning model that integrates peripheral oxygen saturation (SpO₂) signals and ballistocardiography (BCG) data collected using a smart mattress system to estimate the apnea-hypopnea index (AHI). Adult participants undergoing routine overnight PSG for suspected OSA will be enrolled. During sleep, synchronized SpO₂ and BCG signals will be recorded non-invasively.\n\nThe performance of the deep learning model will be evaluated by comparing the predicted AHI values with AHI values derived from PSG. This study seeks to evaluate whether this practical, non-invasive, and scalable approach may support early identification of OSA risk and improve access to sleep disorder assessment in both clinical and home-based settings.","conditions":["Obstructive Sleep Apnea"],"keywords":["Obstructive Sleep Apnea","Ballistocardiography","Peripheral Oxygen Saturation","Deep Learning","Home Sleep Monitoring","Apnea-Hypopnea Index"],"interventions":[],"enrollment":100,"startDate":"2026-03-01","completionDate":"2028-06-30","sex":"ALL","minAge":"20 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 20 years or older.\n* Individuals referred for in-laboratory polysomnography due to suspected obstructive sleep apnea.\n* Able and willing to provide informed consent.\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* Presence of conditions that may interfere with sleep signal acquisition, as determined by the investigator.\n* Prior diagnosis of sleep disorders other than obstructive sleep apnea that could confound study results.","locations":[{"facility":"Fu Jen Catholic University Hospital","city":"New Taipei City","state":"New Taipei City","country":"Taiwan","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ke-Yun Chao Principal Investigator","phone":"+886-905-301-879","email":"C00152@mail.fjuh.fju.edu.tw"}],"primaryOutcomes":["Mean absolute error of apnea-hypopnea index estimation"],"hasResults":false,"conditionSlugs":["als","sleep-apnea"],"drugSlugs":[],"locationSlugs":["new-taipei-city-taiwan"],"enrichment":{"headline":"Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Balli…","inPlainEnglish":"Obstructive sleep apnea (OSA) is a common sleep disorder associated with cardiovascular, metabolic, and neurocognitive complications. The standard diagnostic test for OSA is in-laboratory polysomnography (PSG), which can be costly, labor-intensive, and inconvenient for repeated or large-scale screening.","whoItsFor":["Ages 20 Years to any","Adults aged 20 years or older","Individuals referred for in-laboratory polysomnography due to suspected obstructive sleep apnea"],"whoShouldSkip":["Presence of conditions that may interfere with sleep signal acquisition, as determined by the investigator","Prior diagnosis of sleep disorders other than obstructive sleep apnea that could confound study results"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at New Taipei City. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.939Z"},{"nctId":"NCT07924371","title":"AI-Based Tools for Stroke Diagnosis, Treatment and Outcome Prediction: a Multicentre Prospective Observational Study","officialTitle":"Unleashing a CoMprehensive, Holistic and Patient Centric Stroke Management for a Better, Rapid, AdvancEd and PersonaLised Stroke Diagnosis, TreAtment and Outcome Prediction (UMBRELLA) - Prospective Clinical Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Hospital Universitari Vall d'Hebron Research Institute","sponsorClass":"OTHER","summary":"Stroke is a leading cause of death and adult disability. Stroke care is still limited by fragmented care pathways, non-standardised diagnostic work-up and follow-up, and local, non-interoperable data systems across the pre-hospital, in-hospital and post-hospital settings.\n\nUMBRELLA-P is a multicentre, prospective, observational study in 7 university hospitals in 6 European countries (Spain, Italy, Belgium, the Netherlands, Germany and Switzerland). Adults with clinically suspected acute stroke or transient ischemic attack (TIA) are managed according to standard of care. Routine clinical, imaging, laboratory, ECG and patient-reported data are collected, pseudonymised, stored on a dedicated server at each hospital and harmonised to the OMOP Common Data Model.\n\nThe harmonised data form a federated real-world data platform (U-Platform). On this platform, artificial intelligence (AI) models are trained and validated through federated learning, so that no patient data leave the participating sites. The models aim to predict short- and long-term outcomes, reduce time to treatment, and support diagnosis, triage, discharge, follow-up and secondary prevention. Five clinical sub-studies address pre-hospital triage, fast track to reperfusion, emergent intracerebral hemorrhage (ICH) management, TIA/minor stroke, and cardiac evaluation with blood biomarkers.\n\nThe study is observational. The outputs of the AI models are used for research only and will not influence clinical decisions. Participants are followed for up to 12 months.","conditions":["Stroke","Ischemic Stroke","Intracerebral Hemorrhage","Transient Ischemic Attack","Atrial Fibrillation"],"keywords":["artificial intelligence","federated learning","OMOP common data model","pre-hospital triage","large vessel occlusion","real-world data","outcome prediction"],"interventions":[{"type":"OTHER","name":"Standard of care (no study intervention)"}],"enrollment":10000,"startDate":"2026-09-28","completionDate":"2029-09-30","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Clinical suspicion of acute stroke (including TIA)\n* Written informed consent from the patient or, when not possible, from next of kin; deferred consent is accepted because of the acute setting\n\nAdditional inclusion criteria by sub-study:\n\n* WP2 and WP3: suspected stroke according to ambulance personnel or confirmed LVO stroke, AND symptom onset (or last seen well, if unwitnessed) less than 24 hours earlier\n* WP4: intracerebral hemorrhage, regardless of sex, risk factors or etiology\n* WP5: NIHSS below 7 AND premorbid mRS below 4\n* WP6: acute ischemic stroke, with or without atrial fibrillation\n\nExclusion Criteria:\n\n\\* None","locations":[{"facility":"University Hospitals Leuven - KU Leuven","city":"Leuven","state":"","country":"Belgium","status":"RECRUITING","lat":null,"lon":null},{"facility":"Universitätsklinikum Hamburg-Eppendorf","city":"Hamburg","state":"","country":"Germany","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","city":"Rome","state":"","country":"Italy","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Amsterdam University Medical Centers","city":"Amsterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Erasmus MC University Medical Center Rotterdam","city":"Rotterdam","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Hospital Universitari Vall d'Hebron - Vall d'Hebron Institut de Recerca","city":"Barcelona","state":"","country":"Spain","status":"RECRUITING","lat":null,"lon":null},{"facility":"University Hospital Basel","city":"Basel","state":"","country":"Switzerland","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carlos Molina","phone":"+34 677 189 246","email":"carlosav.molina@vallhebron.cat"}],"primaryOutcomes":["Area Under the Curve (AUC) of the Pre-hospital AI Model for Detection of Large Vessel Occlusion (LVO) Stroke (WP2)","AUC of the Image-based AI Tool for Prediction of Successful Reperfusion After Endovascular Thrombectomy (WP3)","AUC of the AI Model for Prediction of Early Hematoma Expansion in Intracerebral Hemorrhage (WP4)","C-statistic of the AI Risk Model for Prediction of Recurrent Stroke After TIA or Minor Stroke (WP5)","AUC of the Multimodal AI Tool for Identification of a Cardio-aortic Source of Embolism (WP6)"],"hasResults":false,"conditionSlugs":["als","stroke","atrial-fibrillation"],"drugSlugs":[],"locationSlugs":["leuven-belgium","hamburg-germany","rome-italy","amsterdam-netherlands","rotterdam-netherlands","barcelona-spain","basel-switzerland"],"enrichment":{"headline":"Not a traditional drug phase: Standard of care (no study intervention) for Stroke","inPlainEnglish":"Stroke is a leading cause of death and adult disability. Stroke care is still limited by fragmented care pathways, non-standardised diagnostic work-up and follow-up, and local, non-interoperable data systems across the pre-hospital, in-hospital and post-hospital settings.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Clinical suspicion of acute stroke (including TIA)","Additional who can join by sub-study:","WP2 and WP3: suspected stroke according to ambulance personnel or confirmed LVO stroke, AND symptom onset (or last seen well, if unwitnessed) less than 24 hours earlier","WP4: intracerebral hemorrhage, regardless of sex, risk factors or etiology","WP5: NIHSS below 7 AND premorbid mRS below 4","WP6: acute ischemic stroke, with or without atrial fibrillation"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 10,000 people at 7 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.220Z"},{"nctId":"NCT07924436","title":"Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes","officialTitle":"Effects of Whole-Body Vibration Training on Ankle Muscle Activation and Functional Performance in Adults With Obesity With and Without Type 2 Diabetes","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Pamukkale University","sponsorClass":"OTHER","summary":"This study will examine changes in ankle muscle activity and functional performance following whole-body vibration training in women with obesity, with and without type 2 diabetes. It will also compare the responses to training between these two groups.\n\nParticipants will attend supervised training twice a week for eight weeks. During training, they will perform exercises on a platform that produces mechanical vibrations. The exercises will progress gradually and will be adapted to each participant's abilities and tolerance. Each session will include warm-up and cool-down exercises.\n\nBefore and after the training program, researchers will assess muscle activity during normal walking, heel-to-toe walking, and standing with one foot directly in front of the other. Small sensors placed on the skin will record activity from three muscles around each ankle. Walking and functional performance will also be assessed.\n\nThe study aims to help researchers understand whether women with obesity with and without type 2 diabetes show different changes in muscle activity and functional performance after the same training program.","conditions":["Obesity","Diabetes Mellitus, Type 2"],"keywords":["Whole-Body Vibration","Surface Electromyography","Ankle Muscle Activation","Tibialis Anterior","Soleus","Medial Gastrocnemius","Walking","Postural Balance","Functional Performance"],"interventions":[{"type":"DEVICE","name":"Whole-Body Vibration Training"}],"enrollment":30,"startDate":"2026-11-09","completionDate":"2027-01-31","sex":"FEMALE","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Female.\n* Aged 18 to 65 years.\n* Body mass index (BMI) ≥30 kg/m².\n* Willing to participate and provide informed consent.\n* For Group 1: Presence of type 2 diabetes mellitus.\n* For Group 2: Absence of type 2 diabetes mellitus.\n\nExclusion Criteria:\n\n* Cardiopulmonary, orthopedic, or neurological conditions that prevent participation in physical activity.\n* Congenital musculoskeletal deformities.\n* Cognitive impairment that prevents effective communication.\n* Presence of osteoporosis or osteopenia.","locations":[{"facility":"Pamukkale University, Faculty of Physiotherapy and Rehabilitation","city":"Denizli","state":"","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ummuhan Baş Aslan, Prof.","phone":"+902582964295","email":"umbaslan@pau.edu.tr"}],"primaryOutcomes":["Change in Tibialis Anterior Muscle Activation","Change in Soleus Muscle Activation","Change in Medial Gastrocnemius Muscle Activation"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes","obesity"],"drugSlugs":[],"locationSlugs":["denizli-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Whole-Body Vibration Training for Obesity","inPlainEnglish":"This study will examine changes in ankle muscle activity and functional performance following whole-body vibration training in women with obesity, with and without type 2 diabetes. It will also compare the responses to training between these two groups.","whoItsFor":["Ages 18 Years to 65 Years","Women only","Aged 18 to 65 years","Body mass index (body-mass index (BMI)) ≥30 kg/m²","For Group 1: Presence of type 2 diabetes mellitus","For Group 2: Absence of type 2 diabetes mellitus"],"whoShouldSkip":["Cardiopulmonary, orthopedic, or neurological conditions that prevent participation in physical activity","Congenital musculoskeletal deformities","Cognitive impairment that prevents effective communication","Presence of osteoporosis or osteopenia"],"whatHappens":"If you join, the listed intervention(s) are Whole-Body Vibration Training. The registry lists allocation as randomized. This study will examine changes in ankle muscle activity and functional performance following whole-body vibration training in women with obesity, with and without type 2 diabetes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 30 people at Denizli. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.520Z"},{"nctId":"NCT07924462","title":"Chronic Respiratory Disease Participant Engagement Study","officialTitle":"Engagement Study to Establish a Clinical Baseline for Adult Participants With Chronic Respiratory Diseases and Familiarise Them With the Clinical Trials Unit Environment for Future Clinical Trial Participation","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Richmond Research Institute","sponsorClass":"INDUSTRY","summary":"This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD).\n\nThe aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials.\n\nParticipants will attend a study visit at the clinical trials unit, where they will receive a guided tour of the facilities and undergo a range of routine health assessments. These may include a review of their medical history, measurements of height, weight, blood pressure and oxygen levels, breathing tests, blood tests, heart tracing (ECG), liver assessment, and questionnaires about their symptoms and quality of life. Some participants may also undergo genetic testing if it is clinically appropriate and previous results are not available.\n\nThe information collected will help establish a clinical baseline and improve understanding of how respiratory diseases affect people in everyday life. The study will also explore how symptoms and quality of life relate to clinical measurements and other health information.\n\nParticipants will be contacted after their visit to discuss any clinically relevant findings and to answer any questions they may have. If a previously unrecognised condition is identified, participants will be advised appropriately and, with their consent, their GP may be informed to support any further care that may be needed.\n\nThe findings from this study may help improve the design of future clinical trials and support the development of more patient-centred research.","conditions":["Interstitial Lung Disease (ILD)","Chronic Respiratory Diseases","Alpha-1 Antitrypsin Deficiency (AATD)","Chronic Obstructive Pulmonary Disease (COPD)","Asthma","Bronchiectasis"],"keywords":["Alpha-1 Antitrypsin Deficiency","AATD","chronic obstructive pulmonary disease","COPD","asthma","bronchiectasis","interstitial lung disease","ILD"],"interventions":[],"enrollment":500,"startDate":"2026-11","completionDate":"2027-08-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Male or female participants aged ≥ 18 years at the date of signing the PIS/ICF.\n2. Ability to provide written, personally signed, and dated informed consent in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guidelines E6 (R3) (2025) and applicable regulations, before any study-specific procedures are performed.\n3. Diagnosis with or suspicion of chronic respiratory disease including but not limited to: AATD, COPD, Asthma, Bronchiectasis, ILD and any other chronic respiratory diseases considered appropriate by the Investigator and Sponsor\n\nExclusion Criteria:\n\n1. Unwilling or unable to comply with the protocol-defined study assessments.\n2. Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline","locations":[{"facility":"Richmond Pharmacology Limited","city":"London","state":"","country":"United Kingdom","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"James Rickard, MPharm","phone":"+44 (0) 20 7042 5800","email":"jrickard@richmondresearchinstitute.org"}],"primaryOutcomes":["Number of patients indicating willingness to be re-contacted for future clinical trials","Participation feedback questionnaire results using Participant Feedback and Clinical Research Experience Questionnaire"],"hasResults":false,"conditionSlugs":["als","asthma","copd"],"drugSlugs":[],"locationSlugs":["london-united-kingdom"],"enrichment":{"headline":"Chronic Respiratory Disease Participant Engagement Study","inPlainEnglish":"This study is designed for adults who have, or suspected to have, a long-term respiratory (lung) condition such as Alpha-1 Antitrypsin Deficiency (AATD), chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis, or interstitial lung disease (ILD). The aim of the study is to help participants become familiar with the clinical trials unit environment and research team before deciding whether they would like to take part in future clinical trials.","whoItsFor":["Ages 18 Years to any","Male or female participants aged ≥ 18 years at the date of signing the PIS/ICF","Diagnosis with or suspicion of chronic respiratory disease including but not limited to: AATD, COPD, Asthma, Bronchiectasis, ILD and any other chronic respiratory diseases considered appropriate by the Investigator and Sponsor"],"whoShouldSkip":["Unwilling or unable to comply with the protocol-defined study assessments","Any other significant disease or disorder that, in the opinion of the Principal Investigator (PI) or Sponsor, may either place the participant at risk from participation, or influence the clinical baseline"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 500 people at London. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:18.341Z"},{"nctId":"NCT07924618","title":"Ocular Changes in Patients Using Tirzepatide or Semaglutide","officialTitle":"Evaluation of Optic Nerve Head, Retinal Changes, and Choroidal Blood Flow in Patients With Diabetes and Obesity Using Tirzepatide or Semaglutide","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Istanbul University","sponsorClass":"OTHER","summary":"This prospective observational study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.\n\nParticipants will undergo ophthalmologic examinations at baseline and during follow-up. Changes in optic nerve head parameters, retinal thickness, retinal and choroidal microvascular parameters, and choroidal thickness will be assessed using optical coherence tomography (OCT), optical coherence tomography angiography (OCT-A), and other routine ophthalmologic examination methods.\n\nThe study will compare ocular measurements obtained at baseline and during follow-up to investigate changes associated with semaglutide or tirzepatide treatment over a period of up to 18 months.","conditions":["Type 2 Diabetes Mellitus","Obesity"],"keywords":[],"interventions":[{"type":"DRUG","name":"Semaglutide"},{"type":"DRUG","name":"Tirzepatide"}],"enrollment":40,"startDate":"2026-03-01","completionDate":"2027-09-17","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of obesity\n* Receiving semaglutide or tirzepatide as part of routine clinical care\n* Participants with or without type 2 diabetes mellitus\n* Availability for baseline and follow-up ophthalmologic examinations\n\nExclusion Criteria:\n\n* Age under 18 years\n* Not receiving semaglutide or tirzepatide\n* Inability to complete the required ophthalmologic examinations or imaging assessments","locations":[{"facility":"Istanbul University, Istanbul Faculty of Medicine","city":"Istanbul","state":"Istanbul","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in Retinal Nerve Fiber Layer Thickness","Change in Retinal Thickness","Change in Superficial Retinal Vessel Density","Change in Deep Retinal Vessel Density","Change in Foveal Avascular Zone Area","Change in Choriocapillaris Flow Deficit Percentage"],"hasResults":false,"conditionSlugs":["type-2-diabetes","obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["istanbul-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: testing Semaglutide for Type 2 Diabetes Mellitus","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) study aims to evaluate ocular structural and microvascular changes in adults with obesity who are receiving semaglutide or tirzepatide as part of routine clinical care. Participants with and without type 2 diabetes mellitus will be included.","whoItsFor":["Ages 18 Years to any","Age 18 years or older","Diagnosis of obesity","Receiving semaglutide or tirzepatide as part of routine clinical care","Participants with or without type 2 diabetes mellitus","Availability for baseline and follow-up ophthalmologic examinations"],"whoShouldSkip":["Not receiving semaglutide or tirzepatide","Inability to complete the required ophthalmologic examinations or imaging assessments"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 40 people at Istanbul. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.516Z"},{"nctId":"NCT07924657","title":"Acoustic Stimulation During Sleep for Alzheimer's Disease","officialTitle":"Sleep-Stage Acoustic Stimulation for Cognitive Improvement in Alzheimer's Disease: A Randomized Sham-Controlled Study","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Xuanwu Hospital, Beijing","sponsorClass":"OTHER","summary":"This summary focuses on the acoustic stimulation part of the study.\n\nThe goal of this interventional study is to learn if acoustic stimulation during sleep works to improve cognitive function in patients with Alzheimer's disease. It will also learn about safety and feasibility. The main questions are:\n\nDoes acoustic stimulation during NREM sleep improve cognitive function in patients with mild cognitive impairment due to Alzheimer's disease (AD-MCI)? How does acoustic stimulation compare with sham stimulation?\n\nResearchers will compare acoustic stimulation with sham stimulation. Participants will:\n\nBe assigned to the acoustic stimulation group (n=20) or the sham stimulation group (n=20).\n\nReceive a familiar, comfortable sound at the bedside during stable NREM sleep, or sham stimulation, with 30 seconds of stimulation every 1 minute, triggered upon entering NREM sleep, with no limit on the number of stimulations.\n\nComplete cognitive assessments and sleep EEG monitoring before and after the intervention.\n\nBe monitored for safety throughout the study. The study is sponsored by Xuanwu Hospital, Capital Medical University. It is funded by the National Natural Science Foundation of China Key International Cooperation Project (Grant No. 82220108009). The study period runs from ethics approval to December 2024. No other centers are participating. Participants will be 60-75 years old and recruited from the neurology wards of Xuanwu Hospital.","conditions":["Alzheimer s Disease"],"keywords":["alzheimer","Acoustic Stimulation"],"interventions":[{"type":"OTHER","name":"Acoustic Stimulation"}],"enrollment":40,"startDate":"2025-05-01","completionDate":"2026-11-01","sex":"ALL","minAge":"60 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n\\- (1) Meets the diagnostic criteria for mild cognitive impairment (according to Petersen criteria): ① insidious onset; ② memory impairment is the primary complaint; ③ objective evidence of memory decline (defined quantitatively as a decline of more than 1.5 standard deviations below age- and education-matched controls); ④ may be accompanied by other cognitive impairments, but memory decline is more prominent; ⑤ general cognitive function is normal; ⑥ preservation of activities of daily living, with an Activities of Daily Living (ADL) scale score \\<23; ⑦ does not meet the diagnostic criteria for dementia; ⑧ imaging findings support the diagnosis.\n\n(2) Amyloid PET positivity or reduced cerebrospinal fluid amyloid levels. (3) The patient should have a stable and reliable caregiver, or at least be able to maintain frequent contact with a caregiver. The caregiver must be able to accompany and assist the patient throughout the entire study, must accompany the subject to study visits, and must have sufficient interaction and communication with the subject to provide valuable information for the scoring of various scales.\n\nExclusion Criteria:\n\n* (1) Presence of memory and cognitive decline caused by other non-AD conditions, such as other types of dementia, including but not limited to mixed dementia (AD-VaD), vascular dementia (VD), Parkinson's disease dementia (PDD), dementia with Lewy bodies (DLB), Huntington's disease-related dementia, and frontotemporal dementia (FTD); endocrine disorders (e.g., thyroid disease, parathyroid disease); folate or vitamin B12 deficiency; or dementia caused by any other reason.\n\n  (2) At screening, MRI shows significant focal lesions: more than 2 infarcts with a diameter greater than 2 cm, or infarcts in key regions such as the thalamus, hippocampus, entorhinal cortex, perirhinal cortex, angular gyrus, and other cortical and subcortical gray matter nuclei.\n\n  (3) Presence of moderate to severe white matter degeneration (Fazekas score 3-6).\n\n  (4) Presence of metallic foreign bodies or other implanted electronic devices, or claustrophobia, etc., which preclude TMS treatment or MRI scanning.\n\n  (5) Severe visual, auditory, motor, or consciousness impairment that prevents cooperation with examinations and treatment.\n\n  (6) History of seizures (presence of at least 2 unprovoked seizures occurring more than 24 hours apart, or diagnosis of an epilepsy syndrome, or a seizure within the past 12 months).\n\n  (7) Acute cardiovascular or cerebrovascular events (e.g., unstable angina, severe arrhythmia, myocardial infarction, transient ischemic attack, or ischemic stroke) within 3 months before screening.\n\n  (8) Severe systemic diseases involving the heart, lungs, liver, kidneys, etc., identified by laboratory tests or examinations, and not controlled by conventional medication.\n\n  (9) Patients with concurrent malignant tumors; or patients with a life expectancy of less than 1 year due to causes other than AD.\n\n  (10) History of alcohol or drug abuse. (11) Received other TMS treatment within 3 months. (12) Participated in or is currently participating in another clinical trial within 3 months.","locations":[{"facility":"Xuanwu hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Tao Wei, MD","phone":"15650228107","email":"twei2019@126.com"}],"primaryOutcomes":["Computerized 1 × 5 Random Sequence Learning Task Accuracy","Computerized 1 × 5 Random Sequence Learning Task Reaction Time"],"hasResults":false,"conditionSlugs":["alzheimer","als"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Not a traditional drug phase: Acoustic Stimulation for Alzheimer s Disease","inPlainEnglish":"This summary focuses on the acoustic stimulation part of the study. The goal of this treatment study is to learn if acoustic stimulation during sleep works to improve cognitive function in patients with Alzheimer's disease.","whoItsFor":["Ages 60 Years to 75 Years"],"whoShouldSkip":["(3) Presence of moderate to severe white matter degeneration (Fazekas score 3-6)","(4) Presence of metallic foreign bodies or other implanted electronic devices, or claustrophobia, etc., which preclude TMS treatment or MRI scanning","(5) Severe visual, auditory, motor, or consciousness impairment that prevents cooperation with examinations and treatment","(6) History of seizures (presence of at least 2 unprovoked seizures occurring more than 24 hours apart, or diagnosis of an epilepsy syndrome, or a seizure within the past 12 months)","(7) Acute cardiovascular or cerebrovascular events (e.g., unstable angina, severe arrhythmia, myocardial infarction, transient ischemic attack, or ischemic stroke) within 3 months before screening","(8) Severe systemic diseases involving the heart, lungs, liver, kidneys, etc., identified by laboratory tests or examinations, and not controlled by conventional medication","(9) Patients with concurrent malignant tumors; or patients with a life expectancy of less than 1 year due to causes other than AD"],"whatHappens":"If you join, the listed intervention(s) are Acoustic Stimulation. The registry lists allocation as randomized. This summary focuses on the acoustic stimulation part of the study.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Beijing. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.322Z"},{"nctId":"NCT07924774","title":"Cognitive Rehabilitation of Executive Dysfunction With the Goal Management Training (GMT) - Exploring Variations in Mode of Administration, Frequency and Intensity.","officialTitle":"Cognitive Rehabilitation of Executive Dysfunction With the Goal Management Training (GMT) - Exploring Variations in Mode of Administration, Frequency and Intensity.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Karolinska Institutet","sponsorClass":"OTHER","summary":"Executive functions help people initiate, organize, monitor, and complete everyday activities. Difficulties with these functions are common after acquired brain injury and may also occur in people with long-term pain. A person may understand what needs to be done but still have difficulty starting an activity, maintaining focus on the overall goal, monitoring performance, adjusting a plan, or completing the activity. These difficulties can affect independence, rehabilitation, work, studies, family life, and participation in society.\n\nGoal Management Training is a structured cognitive rehabilitation program designed to help people manage goal-directed activities. Participants learn strategies for stopping ongoing or automatic behavior, identifying the current goal, dividing complex activities into manageable steps, monitoring progress, and redirecting attention when they lose track of the goal.\n\nThis multicenter study evaluates the implementation and effects of a Swedish version of Goal Management Training in adults with executive difficulties or reduced working memory following acquired brain injury or in association with long-term pain. The program is delivered as part of clinical rehabilitation at participating centers in Sweden.\n\nThe study examines whether Goal Management Training can be implemented in different rehabilitation settings and delivered in different clinical formats, including group-based, individually delivered, in-person, and remotely delivered treatment. The choice of format is based on the participant's clinical rehabilitation needs and the conditions at the participating center. Specific program formats in terms of intensity (five-, seven-, and nine-session versions of Goal Management Training), may be evaluated in separate analyses within the overall study.\n\nChanges are assessed in areas including cognitive functioning, everyday executive difficulties, activity, and participation. The study also examines whether improvements are maintained after the intervention and explores differences in patterns of response between participants and treatment formats.\n\nThe overall aim is to improve knowledge about how Goal Management Training can be implemented in Swedish rehabilitation services and adapted to different patient groups, clinical settings, and modes of delivery. The findings may contribute to more accessible and individually adapted cognitive rehabilitation for people with acquired brain injury or long-term pain.","conditions":["Acquired Brain Injury (Including Stroke)","Chronic Pain"],"keywords":["brain injury","cognitive rehabilitation","dysexecutive syndrome","executive functions","generalization","goal management training","attention","longitudinal"],"interventions":[{"type":"BEHAVIORAL","name":"Goal Management Training (GMT)"}],"enrollment":120,"startDate":"2022-03-01","completionDate":"2029-12-31","sex":"ALL","minAge":"18 Years","maxAge":"67 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\nInclusion criteria meeting either of the following clinical profiles:\n\n1 a) Acquired brain injury (ABI) with an indicated need for rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits.\n\n1 b) Referred to the Pain Section at the Regional University Hospital (RUS) for standard pain rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits.\n\n2\\. Aged between 18 and 67 years. 3. Participating in team-based rehabilitation at one of the participating multicenter sites.\n\n4\\. Provided written informed consent to participate in the study from the patient or a next of kin/legally authorized representative.\n\nThe intervention requires at least moderate illness insight, some awareness of how difficulties manifest in daily life, and adequate memory retention to learn and generalize strategies outside of session. Consequently, the following exclusion criteria apply:\n\n1. Impaired fluid/logical reasoning, defined as scoring 1.5 standard deviations (SD) or more below the mean on the WAIS Matrices subtest (scaled score \\< 6).\n2. Severe insight deficits that significantly diminish motivation to engage in the treatment.\n3. Severe memory impairment that prevents the development of clinical insight and the ability to generalize learned strategies.\n4. Insufficient proficiency in the Swedish language to comprehend and actively participate in the treatment protocol.\n5. Extensive or severe psychiatric comorbidities that interfere with active participation.\n6. Substance abuse/dependence, ongoing use of heavily sedating medications, or presence of a progressive neurological disease.","locations":[{"facility":"Garnis Rehabiliteringscenter","city":"Luleå","state":"Norrbotten County","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Danderyd Hospital","city":"Stockholm","state":"Stokcholm","country":"Sweden","status":"RECRUITING","lat":null,"lon":null},{"facility":"Östersunds Rehabcentrum","city":"Stockholm","state":"Östersund","country":"Sweden","status":"ACTIVE_NOT_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Gabriela Markovic, PhD","phone":"0046707777452","email":"gabriela.markovic@ki.se"},{"name":"Marika Möller, associate professor","phone":"0046725694065","email":"marika.moller@ki.se"}],"primaryOutcomes":["Change following Goal Management Training in participant-reported everyday executive difficulties over the follow-up period measured with the Dysexecutive Questionnaire (DEX)"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["lule-sweden","stockholm-sweden"],"enrichment":{"headline":"Not a traditional drug phase: Goal Management Training (GMT) for Acquired Brain Injury (Including Stroke)","inPlainEnglish":"Executive functions help people initiate, organize, monitor, and complete everyday activities. Difficulties with these functions are common after acquired brain injury and may also occur in people with long-term pain.","whoItsFor":["Ages 18 Years to 67 Years","who can join meeting either of the following clinical profiles:","1 a) Acquired brain injury (ABI) with an indicated need for rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits","1 b) Referred to the Pain Section at the Regional University Hospital (RUS) for standard pain rehabilitation and presenting with self-reported and/or test-verified executive dysfunction or working memory deficits","2\\. Aged between 18 and 67 years. 3. Participating in team-based rehabilitation at one of the participating multicenter sites","The intervention requires at least moderate illness insight, some awareness of how difficulties manifest in daily life, and adequate memory retention to learn and generalize strategies outside of session. Consequently, the following"],"whoShouldSkip":["Impaired fluid/logical reasoning, defined as scoring 1.5 standard deviations (SD) or more below the mean on the WAIS Matrices subtest (scaled score \\< 6)","Severe insight deficits that significantly diminish motivation to engage in the treatment","Severe memory impairment that prevents the development of clinical insight and the ability to generalize learned strategies","Insufficient proficiency in the Swedish language to comprehend and actively participate in the treatment protocol","Extensive or severe psychiatric comorbidities that interfere with active participation","Substance abuse/dependence, ongoing use of heavily sedating medications, or presence of a progressive neurological disease"],"whatHappens":"If you join, the listed intervention(s) are Goal Management Training (GMT). The registry lists allocation as randomized. Executive functions help people initiate, organize, monitor, and complete everyday activities.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at 3 sites. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.216Z"},{"nctId":"NCT07924839","title":"PM2.5 Exposure, Obesity, and Cardiovascular Health","officialTitle":"Investigating Interactions Between PM2.5 Exposure, Obesity, Cardiovascular Health and Dietary Antioxidant in Subjects With Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Michigan State University","sponsorClass":"OTHER","summary":"Obesity and exposure to fine particulate matter (particles of aerodynamic diameter less than 2.5 µm, PM2.5) air pollution are established risk factors for cardiovascular (CV) morbidity and mortality. This proposed pilot project seeks to assess interactions between PM2.5 exposure, obesity, CV health, and dietary antioxidant in subjects with obesity.","conditions":["Cardiovascular (CV) Risk"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Air filtration systems without filters (sham)"}],"enrollment":20,"startDate":"2025-06-18","completionDate":"2026-10-31","sex":"ALL","minAge":"21 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* ≥21 years old\n* diagnosis of hypertension (BP ≥140/90 mm Hg)\n* obesity (BMI\\>30)\n\nExclusion Criteria:\n\n* any CV event (myocardial infarction, stroke, heart failure) in the past 3 months\n* unstable CV condition (class 3-4 angina or heart failure) or any medical condition that would place the subject at risk from participation or jeopardize study integrity (per investigators)\n* expected overnight travel outside their home during the 9-week study period\n* unable to comprehend/sign informed consent\n* lung disease requiring oxygen\n* cancer receiving active treatment or chemotherapy\n* CPAP use for sleep apnea\n* CV medication change in the prior month","locations":[{"facility":"Michigan State University","city":"East Lansing","state":"Michigan","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Brachial blood pressure"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["east-lansing-michigan"],"enrichment":{"headline":"Not a traditional drug phase: Air filtration systems without filters (sham) for Cardiovascular (CV) Risk","inPlainEnglish":"Obesity and exposure to fine particulate matter (particles of aerodynamic diameter less than 2.5 µm, PM2.5) air pollution are established risk factors for cardiovascular (CV) morbidity and mortality. This proposed pilot project seeks to assess interactions between PM2.5 exposure, obesity, CV health, and dietary antioxidant in subjects with obesity.","whoItsFor":["Ages 21 Years to any","diagnosis of hypertension (BP ≥140/90 mm Hg)"],"whoShouldSkip":["any CV event (myocardial infarction, stroke, heart failure) in the past 3 months","unstable CV condition (class 3-4 angina or heart failure) or any medical condition that would place the subject at risk from participation or jeopardize study integrity (per investigators)","expected overnight travel outside their home during the 9-week study period","lung disease requiring oxygen","cancer receiving active treatment or chemotherapy","CPAP use for sleep apnea","CV medication change in the prior month"],"whatHappens":"If you join, the listed intervention(s) are Air filtration systems without filters (sham). The registry lists allocation as randomized. Obesity and exposure to fine particulate matter (particles of aerodynamic diameter less than 2.5 µm, PM2.5) air pollution are established risk factors for cardiovascular (CV) morbidity and mortality.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at East Lansing. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.832Z"},{"nctId":"NCT07924852","title":"Neuromodulation of Motivation and Reward Oscillations","officialTitle":"Delta and Theta-Frequency Transcranial Alternating Stimulation Neuromodulation of Motivation and Reward Oscillations in Disorder of Reward Dysfunction.","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"DOUBLE","sponsor":"Florida State University","sponsorClass":"OTHER","summary":"Cannabis use disorder (CUD) and major depressive disorder (MDD) are among the most prevalent psychiatric conditions in the United States, affecting an estimated 20.6 million and 21 million adults respectively. Both disorders are characterized by anhedonia, diminished motivation, and blunted neural reward sensitivity. This shared dysregulated reward-processing may reflect a common prefrontal oscillatory dysfunction, centralized in mesolimbic dopaminergic reward pathways. This proposed project aims to investigate if transcranial alternating current (tACS) can modulate motivational behaviours and neural reward responsivity in participants with MDD and/or CUD during an effortful reward task. The investigators hypothesize that delta transcranial alternating current stimulation will produce a greater neural reward responsivity (RewP), and motivational behaviour during an effortful reward task.","conditions":["Cannabis Use Disorder","Major Depression","Anhedonia","Transcranial Alternating Current Stimulation"],"keywords":["Cannabis Use Disorder","Depression","Neurostimulation","Reward Responsivity"],"interventions":[{"type":"DEVICE","name":"Transcranial Alternating Current Stimulation Sham"},{"type":"DEVICE","name":"Transcranial Alternating Current Delta Stimulation."},{"type":"DEVICE","name":"Transcranial Alternating Current Theta Stimulation"}],"enrollment":54,"startDate":"2026-11-01","completionDate":"2027-04-01","sex":"ALL","minAge":"18 Years","maxAge":"55 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria (General):\n\n* Aged between 18 - 55 years old.\n* Able to provide informed consent\n* Have normal to corrected vision\n* Willing to comply with all study procedures and be available for the duration of the study\n* Speak and understand English.\n* Negative THC saliva test and alcohol breathalyzer at all lab visits.\n* Negative UTOX for any substance other than THC.\n\nExclusion Criteria (General):\n\n* Mania history (Bipolar I, or current mania).\n* Psychosis history.\n* Current suicide intent (score \\>4 on C-SRSS, or intent \\>0 on SRA)\n* Current moderate-to-severe SUD or AUD (Except CUD and nicotine for NEMO-CUD).\n* Current pregnancy.\n* Seizure, neurological conditions, or brain surgery history.\n* Implanted medical devices (e.g., cochlear implants, cardiac pacemakers).\n* Change in psychotropic medication in the past 3 months (i.e., medication needs to be stable for 12 weeks).\n* Use of seizure threshold lowering medication (e.g., Stimulants, Benzos, SNRIs, Antipsychotics \\[Adderall, Vyvanse, Xanax, Wellbutrin, Cymbalta, Lithium\\] - SSRIs not exclusionary).\n\nSpecific CUD Inclusion:\n\n* Avg. 6+ cannabis use days per week over the past 3-months, and 24+ cannabis use days in the past 30 days.\n* Primary delta-9 or THC-A cannabis flower or vape concentrate user.\n* Current moderate-to-severe CUD (4+ criteria in the past year, at least one criterion other than craving must be met in the past three months).\n* Cannabis is the primary substance of use (Nicotine dependence is allowable)\n* Not currently receiving treatment for cannabis, planning to immediately quit or reduce use.\n* Lifetime history of MDE/PDD must have lifetime anhedonia symptom and/or heavy cannabis user (3+ sessions daily for at least past year including the past 3-months and past 30 days).\n\nSpecific MDD Inclusion:\n\n* Current MDE diagnosis.\n* No lifetime history of severe SUD.\n* No current moderate-to-severe SUD.\n* 100% of NEMO-MDD participants elevated anhedonia on TEPS-C (i.e., 32 or lower on TEPS-C subscale).\n\nSpecific Control Inclusion:\n\n* No current or historical psychiatric diagnosis.","locations":[{"facility":"The BRAINS Lab at Florida State University","city":"Tallahassee","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The Riddle Lab at Florida State University","city":"Tallahassee","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Zoe Howell Doctoral Student PI, M.Res.","phone":"850-644-2445","email":"brains@psy.fsu.edu"}],"primaryOutcomes":["Effort-updating behavior during decision period.","Delta phase coherence between left lateral and medial frontal electrodes during decision period following a win versus following a loss.","Reward positivity amplitude"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["tallahassee-florida"],"enrichment":{"headline":"Not a traditional drug phase: Transcranial Alternating Current Stimulation Sham for Cannabis Use Disorder","inPlainEnglish":"Cannabis use disorder (CUD) and major depressive disorder (major depression) are among the most prevalent psychiatric conditions in the United States, affecting an estimated 20.6 million and 21 million adults respectively. Both disorders are characterized by anhedonia, diminished motivation, and blunted neural reward sensitivity.","whoItsFor":["Ages 18 Years to 55 Years","Aged between 18 - 55 years old","Have normal to corrected vision","Negative THC saliva test and alcohol breathalyzer at all lab visits","Negative UTOX for any substance other than THC"],"whoShouldSkip":["Mania history (Bipolar I, or current mania)","Current suicide intent (score \\>4 on C-SRSS, or intent \\>0 on SRA)","Current moderate-to-severe SUD or AUD (Except CUD and nicotine for NEMO-CUD)","Seizure, neurological conditions, or brain surgery history","Implanted medical devices (e.g., cochlear implants, cardiac pacemakers)","Change in psychotropic medication in the past 3 months (i.e., medication needs to be stable for 12 weeks)","Use of seizure threshold lowering medication (e.g., Stimulants, Benzos, SNRIs, Antipsychotics \\[Adderall, Vyvanse, Xanax, Wellbutrin, Cymbalta, Lithium\\] - SSRIs not exclusionary)"],"whatHappens":"If you join, the listed intervention(s) are Transcranial Alternating Current Stimulation Sham, Transcranial Alternating Current Delta Stimulation., or Transcranial Alternating Current Theta Stimulation. The registry lists allocation as randomized. Cannabis use disorder (CUD) and major depressive disorder (major depression) are among the most prevalent psychiatric conditions in the United States, affecting an estimated 20.6 million and 21 million adults respectively.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 54 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.107Z"},{"nctId":"NCT07924917","title":"Individualized Temporally Interfering Electrical Stimulation in Major Depressive Disorder","officialTitle":"Closed-Loop Bio-Machine Interaction System and Applications in Psychiatric Diagnosis and Treatment","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Tianjin Medical University General Hospital","sponsorClass":"OTHER","summary":"Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (MDD) has not been established. This trial aims to evaluate the efficacy and safety of TI electrical stimulation in MDD patients.","conditions":["Major Depressive Disorder (MDD)"],"keywords":[],"interventions":[{"type":"DEVICE","name":"Single-target active temporally interfering electrical stimulation"},{"type":"DEVICE","name":"Dual-target active temporally interfering electrical stimulation"},{"type":"DEVICE","name":"Sham temporally interfering electrical stimulation"}],"enrollment":75,"startDate":"2025-03-11","completionDate":"2027-06-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for MDD, confirmed independently by two psychiatrists;\n2. Currently experiencing a depressive episode;\n3. Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;\n4. Aged between 18-65 years;\n5. No restrictions on sex or gender;\n6. Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;\n7. Normal or corrected-to-normal vision and normal hearing;\n8. No use of antidepressant within two weeks prior to enrollment, or ongoing antidepressant treatment judged by a psychiatrist to be in a stable treatment phase;\n9. Ability to read and understand informed consent and self-report assessment scales;\n10. Willingness to participate in the study, with written informed consent provided by the participant or a legal guardian.\n\nExclusion Criteria:\n\n1. History of any psychiatric disorder other than MDD;\n2. History of traumatic brain injury or coma;\n3. History of organic brain disease or severe systemic medical illness;\n4. History of cochlear implants, pacemakers, or other implanted brain devices;\n5. History of epileptic seizures or family history of epilepsy;\n6. Obvious suicidal or impulsive violent behavior;\n7. Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;\n8. History of alcohol use disorder or use of other psychoactive substances;\n9. Participation in other interventional clinical trials;\n10. Any condition precluding informed consent or compliance with study procedures.","locations":[{"facility":"Fuzhou Neuropsychiatric Hospital Affiliated to Fujian Medical University","city":"Fuzhou","state":"Fujian","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Tianjin Anding Hospital","city":"Tianjin","state":"Tianjin Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xianyun Kang","phone":"+862283612122","email":"xianyunkang@tju.edu.cn"}],"primaryOutcomes":["Hamilton Depression Rating Scale 17-item (HAMD-17)"],"hasResults":false,"conditionSlugs":["depression"],"drugSlugs":[],"locationSlugs":["fuzhou-china","tianjin-china"],"enrichment":{"headline":"Not a traditional drug phase: Single-target active temporally interfering electrical stimulation for Major Depressive Disorder (MDD)","inPlainEnglish":"Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution. Although its effects on human brain function and behavior have been increasingly investigated, its clinical utility in major depressive disorder (major depression) has not been established.","whoItsFor":["Ages 18 Years to 65 Years","Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for major depression, confirmed independently by two psychiatrists;","Currently experiencing a depressive episode;","Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17;","Aged between 18-65 years;","No restrictions on sex or gender;","Attained at least junior high school education; lower education permitted if cognitive capacity is confirmed by a physician;","Normal or corrected-to-normal vision and normal hearing;"],"whoShouldSkip":["History of any psychiatric disorder other than major depression;","History of traumatic brain injury or coma;","History of organic brain disease or severe systemic medical illness;","History of cochlear implants, pacemakers, or other implanted brain devices;","History of epileptic seizures or family history of epilepsy;","Obvious suicidal or impulsive violent behavior;","Receipt of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or other neuromodulation therapies within the past six months;"],"whatHappens":"If you join, the listed intervention(s) are Single-target active temporally interfering electrical stimulation, Dual-target active temporally interfering electrical stimulation, or Sham temporally interfering electrical stimulation. The registry lists allocation as randomized. Temporally interfering (TI) electrical stimulation is a novel noninvasive neuromodulation technique with high spatial resolution.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 75 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.103Z"},{"nctId":"NCT07924943","title":"Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation","officialTitle":"Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) in Patients With Hepatocellular Carcinoma (HCC) Prior to Liver Transplantation A Randomized, 2-arm Phase II Study Comparing the Combination of Transarterial Chemoembolization (TACE) and Stereotactic Body Radiation (SBRT) Versus TACE Alone in Patients With Hepatocellular Carcinoma as Bridging to Liver Transplantation With Regard to Explant Histopathology","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"AIO-Studien-gGmbH","sponsorClass":"OTHER","summary":"In this randomised study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.","conditions":["HCC - Hepatocellular Carcinoma"],"keywords":["HCC","TACE","SBRT"],"interventions":[{"type":"PROCEDURE","name":"Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation"},{"type":"PROCEDURE","name":"The patients will receive two procedures of TACE prior to liver transplantation"}],"enrollment":44,"startDate":"2026-07-28","completionDate":"2031-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Written informed consent obtained from the subject prior to performing any protocol related procedures, including screening evaluations.\n2. Age ≥ 18 years at time of study entry.\n3. HCC diagnosed by histopathology and/or according to EASL or AASLD criteria at an early stage (BCLC A or UNOS T2), without any curative treatment option (resection or ablation) other than liver transplantation as determined by tumor board decision of at least one tumor lesion. Guidance: Patients with prior HCC who had surgery or locoregional treatment and had a complete remission for over 2 years and develop denovo HCC at a location different from previously treated HCC lesion(s) are eligible to participate.\n4. Patients planned for liver transplantation after discussion within a multidisciplinary board.\n5. Patients eligible to receive a matchReMELD-Na (SE-ReMELD-Na) - Score for hepatocellular carcinoma according to German transplant regulations. Guidance: All listing assessments must be completed before first on-study radiologic tumor assessment (first radiologic tumor assessment in treatment follow-up).\n6. Treatment of all lesions by SBRT is feasible as determined by the local physician. The central review board recommendation process has been initiated (i.e. image upload by site).\n7. At least one measurable site of disease with spiral CT scan or MRI according to mRECIST for HCC.\n8. Sufficient liver function (\\< Child Pugh B8)\n9. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n10. Adequate blood count, liver enzymes and renal function:\n\n    1. Hemoglobin ≥ 7 g/dL, absolute neutrophil count ≥ 1000 /µL, platelets ≥ 35000/µL\n    2. Total bilirubin and serum albumin as part of Child Pugh requirement\n    3. ALAT and ASAT ≤5 x ULN\n11. Patients with active HIV Infection must show a CD4 cell count above 200/µL and no detectable HIV RNA for at least three months prior to the study\n12. Female patients with reproductive potential must have a negative urine or serum pregnancy test within 14 days prior to start of the study (randomization).\n13. Patients of childbearing potential who are sexually active must use an adequate contraceptive method with a failure rate less than 1 % per year. Enrolled patients must agree to use adequate contraception for the duration of study treatment and up to 6 months after the end of the treatment (depending on treatment received), manufactures recommendation (TACE) and local guidelines.\n14. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\nExclusion Criteria:\n\n1. Involvement in the planning and/or conduct of the study.\n2. Prior local tumor specific treatment of the same tumor nodule within the last 24 months.\n3. Histological proven fibrolamellar HCC or mixed HCC/cholangiocarcinoma.\n4. Other invasive malignancies within the past 2 years (except for non-melanoma skin cancer or non-invasive bladder cancer).\n5. Impaired liver function Child-Pugh Class B \\> 7.\n6. Ongoing or active systemic infection or psychiatric illness/social situations that would limit compliance with study requirements. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.\n7. Dementia or significantly altered mental status that would prohibit the understanding or rendering of information, consent, and compliance with the requirements of the protocol.\n8. Pregnancy and breastfeeding. Should a patient become pregnant, the treating physician has to be informed immediately.\n9. Any condition, comorbidity or circumstance that, in the opinion of the investigator, would interfere with evaluation of study treatment or affect patient safety or study results.\n10. Weight less than or equal to 30 kg.\n11. Prior radiotherapy to the upper abdomen","locations":[{"facility":"Klinik und Poliklinik für Innere Medizin II, TUM Klinikum, Rechts der Isar","city":"München","state":"","country":"Germany","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ursula Ehmer, PD Dr. med.","phone":"+49 (0) 89 4140-9324","email":"ursula.ehmer@tum.de"},{"name":"Ulrike Bauer, Dr. med. univ. Dr. med.","phone":"","email":"Ulrike.Bauer@mri.tum.de"}],"primaryOutcomes":["Primary Endpoint: histopathological response (presence of vital tumor tissue) in explant histopathology after liver transplantation."],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["m-nchen-germany"],"enrichment":{"headline":"Not a traditional drug phase: Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation for HCC - Hepatocellular Carcinoma","inPlainEnglish":"In this randomly assigned study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.","whoItsFor":["Ages 18 Years to any","Age ≥ 18 years at time of study entry","Patients planned for liver transplantation after discussion within a multidisciplinary board","Treatment of all lesions by SBRT is feasible as determined by the local physician. The central review board recommendation process has been initiated (i.e. image upload by site)","At least one measurable site of disease with spiral CT scan or MRI according to mRECIST for HCC","Sufficient liver function (\\< Child Pugh B8)","Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1","Adequate blood count, liver enzymes and renal function:"],"whoShouldSkip":["Involvement in the planning and/or conduct of the study","Prior local tumor specific treatment of the same tumor nodule within the last 24 months","Histological proven fibrolamellar HCC or mixed HCC/cholangiocarcinoma","Other invasive malignancies within the past 2 years (except for non-melanoma skin cancer or non-invasive bladder cancer)","Impaired liver function Child-Pugh Class B \\> 7","Dementia or significantly altered mental status that would prohibit the understanding or rendering of information, consent, and compliance with the requirements of the protocol","Pregnancy and breastfeeding. Should a patient become pregnant, the treating physician has to be informed immediately"],"whatHappens":"If you join, the listed intervention(s) are Stereotactic body radiation therapy (SBRT) in addition to TACE prior to liver transplantation, or The patients will receive two procedures of TACE prior to liver transplantation. The registry lists allocation as randomized. In this randomly assigned study it should be investigated, whether and to what extent standard TACE treatment combined with additional stereotactic body radiotherapy (SBRT) leads to improved outcomes for patients with HCC when used as a bridging therapy prior to liver transplantation.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 44 people at München. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.621Z"},{"nctId":"NCT07924956","title":"Explore the Weight Loss Effect of Amway \"BODY TRIMMER\"","officialTitle":"A Prospective, Parallel-Controlled Clinical Trial to Explore the Weight Loss Effect of Amway \"BODY TRIMMER\" on Study Participants With Abdominal Obesity","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Amway (China) R&D Center","sponsorClass":"INDUSTRY","summary":"The goal of this clinical trial is to explore the weight loss effect of Amway \"BODY TRIMMER\" on study participants with abdominal obesity. The main questions it aim to answer is:\n\nDoes Amway \"BODY TRIMMER\" reduce the weight of Study participants? Researchers will compare both high and low dosage groups (after taking Amway \"BODY TRIMMER\" ) to observe the improvement of weight loss indicators in abdominal obesity.\n\nParticipants will:\n\nTake Amway \"BODY TRIMMER\" every day for 3 months. Regularly report on three meals. Visit the clinic once every 4 weeks for checkups and tests.","conditions":["Abdominal Obesity"],"keywords":[],"interventions":[{"type":"OTHER","name":"Body trimmer intervention dose 1"},{"type":"OTHER","name":"Body trimmer intervention dose 2"}],"enrollment":110,"startDate":"2026-10-15","completionDate":"2027-02","sex":"ALL","minAge":"30 Years","maxAge":"65 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Male and female participants aged 30 to 65 years (inclusive), with an equal male-to-female enrollment ratio.\n* Presence of abdominal obesity, defined as: waist circumference ≥90 cm in males or ≥85 cm in females; or waist-to-hip ratio (WHR) ≥0.90 in males or ≥0.85 in females.\n* Body mass index (BMI) ≥24.0 kg/m².\n* No use of any prescription drugs, over-the-counter medications, traditional Chinese medicines, or health supplements that may affect blood pressure, lipid profile, glucose metabolism, endocrine function, or intestinal microbiota within 1 month prior to screening.\n* No documented history of allergy or intolerance to any components of the investigational product.\n* Able to fully understand the study objectives, procedures, and potential adverse reactions, voluntarily provides written informed consent, and is willing and able to complete the 12-week intervention and scheduled follow-up assessments.\n\nExclusion Criteria:\n\n* A history of clinically significant hepatic or renal dysfunction (mild simple non-alcoholic fatty liver disease is excluded), untreated or managed thyroid disorders including hyperthyroidism and hypothyroidism, or any cardiovascular or cerebrovascular disease requiring ongoing medical intervention.\n* Diagnosis of any chronic or active gastrointestinal or intestinal disease within 1 year prior to screening (e.g., chronic diarrhea, chronic constipation), regardless of disease status at enrollment.\n* Use of any weight-loss interventions within 3 months before screening, including weight-loss prescription drugs, over-the-counter products, traditional Chinese medicines, oral or injectable health supplements, or weight-loss devices. Examples include but are not limited to: semaglutide, liraglutide, phentermine, orlistat, amylase inhibitors, L-carnitine preparations, prebiotic enzyme supplements, and chitosan capsules.\n* Screening laboratory values showing total cholesterol (TC) \\>10.34 mmol/L or triglycerides (TG) \\>5.7 mmol/L.\n* Excessive alcohol consumption, defined as a weekly pure alcohol intake exceeding 210 g in males or 140 g in females (referencing the 2024 Guidelines for the Prevention and Treatment of Metabolic-Associated Fatty Liver Disease).\n* Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening (without antihypertensive medication).\n* Known allergy or hypersensitivity to any ingredients of the investigational product.\n* Pregnancy or breastfeeding status at screening.\n* Participants or their partners with a planned pregnancy, sperm donation, or egg donation from the time of informed consent through 3 months after the final study product administration, who are unwilling to practice effective non-study contraception during this period.\n* Any form of intentional dietary restriction undertaken from 30 days prior to informed consent up to the enrollment day.\n* Presence of psychiatric disorders or any other medical or social conditions deemed inappropriate for study participation by the investigator's clinical judgment.","locations":[{"facility":"Shanghai Fengxian District Central Hospital","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Principal Investigator","phone":"18018820470","email":"shfxec@163.com"}],"primaryOutcomes":["Weight"],"hasResults":false,"conditionSlugs":["als","obesity"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: Body trimmer intervention dose 1 for Abdominal Obesity","inPlainEnglish":"The goal of this clinical trial is to explore the weight loss effect of Amway \"BODY TRIMMER\" on study participants with abdominal obesity. The main questions it aim to answer is: Does Amway \"BODY TRIMMER\" reduce the weight of Study participants?","whoItsFor":["Ages 30 Years to 65 Years","Male and female participants aged 30 to 65 years (inclusive), with an equal male-to-female enrollment ratio","Presence of abdominal obesity, defined as: waist circumference ≥90 cm in males or ≥85 cm in females; or waist-to-hip ratio (WHR) ≥0.90 in males or ≥0.85 in females","Body mass index (body-mass index (BMI)) ≥24.0 kg/m²","No use of any prescription drugs, over-the-counter medications, traditional Chinese medicines, or health supplements that may affect blood pressure, lipid profile, glucose metabolism, endocrine function, or intestinal microbiota within 1 month prior to screening","No documented history of allergy or intolerance to any components of the investigational product"],"whoShouldSkip":["Diagnosis of any chronic or active gastrointestinal or intestinal disease within 1 year prior to screening (e.g., chronic diarrhea, chronic constipation), regardless of disease status at enrollment","Screening laboratory values showing total cholesterol (TC) \\>10.34 mmol/L or triglycerides (TG) \\>5.7 mmol/L","Excessive alcohol consumption, defined as a weekly pure alcohol intake exceeding 210 g in males or 140 g in females (referencing the 2024 Guidelines for the Prevention and Treatment of Metabolic-Associated Fatty Liver Disease)","Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening (without antihypertensive medication)","Known allergy or hypersensitivity to any ingredients of the investigational product","Pregnancy or breastfeeding status at screening","Presence of psychiatric disorders or any other medical or social conditions deemed inappropriate for study participation by the investigator's clinical judgment"],"whatHappens":"If you join, the listed intervention(s) are Body trimmer intervention dose 1, or Body trimmer intervention dose 2. The registry lists allocation as randomized. The goal of this clinical trial is to explore the weight loss effect of Amway \"BODY TRIMMER\" on study participants with abdominal obesity.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 110 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.827Z"},{"nctId":"NCT07925021","title":"A Study of SYS6010 Combined With Enlonstobart in Patients With Previously Systemic Treatment-Naive R/M Nasopharyngeal Carcinoma","officialTitle":"A Randomized, Open-label, Multicenter Phase Ⅲ Trial to Evaluate the Efficacy and Safety of SYS6010 Combined With Enlonstobart Injection Versus Tislelizumab Combined With Chemotherapy (Gemcitabine Plus Cisplatin) in Patients With Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma","status":"RECRUITING","phases":["PHASE3"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"PARALLEL","masking":"NONE","sponsor":"CSPC Megalith Biopharmaceutical Co.,Ltd.","sponsorClass":"INDUSTRY","summary":"This is a randomized, open-label, multicenter phase Ⅲ trial to evaluate the efficacy and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-naive recurrent or metastatic nasopharyngeal carcinoma","conditions":["Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma"],"keywords":["Nasopharyngeal Carcinoma"],"interventions":[{"type":"DRUG","name":"SYS6010 combined with Enlonstobart"},{"type":"DRUG","name":"Tislelizumab combined with chemotherapy"}],"enrollment":424,"startDate":"2026-11-06","completionDate":"2029-10-01","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Female participants aged ≥ 18 years (as of the date of signed informed consent).\n2. Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma, with no prior systemic therapy for recurrent or metastatic nasopharyngeal carcinoma.\n3. For recurrent nasopharyngeal carcinoma: the disease is currently not eligible for local or curative-intent treatment, and the interval from completion of adjuvant/neoadjuvant therapy or concurrent chemoradiotherapy to disease recurrence must be more than 6 months. Metastatic nasopharyngeal carcinoma is defined as stage IV per AJCC 9.0 staging system.\n4. Willing to provide tumor tissue samples for testing of EGFR protein and PD-L1 expression. If sample collection is not feasible for certain reasons, eligibility will be determined by joint assessment of the investigator and sponsor\n5. At least one measurable lesion confirmed by CT or MRI per RECIST v1.1. The lesion has not received prior radiotherapy, or has demonstrated clear progression after prior radiotherapy.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n7. Expected survival of the participant is ≥ 3 months.\n8. Major organ function must meet the following criteria within 7 days prior to enrollment:\n\n   1. Complete blood count (no whole blood, red blood cell, or platelet transfusion, and no administration of hematopoietic growth factors \\[G-CSF or GM-CSF\\], erythropoietin \\[EPO\\], or thrombopoietin \\[TPO\\] to correct blood cell counts within 14 days before sampling):i. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9/L;Platelet count (PLT) ≥ 100 × 10\\^9/L;Hemoglobin (HGB) ≥ 90 g/L.\n   2. Blood biochemistry: Serum creatinine: Creatinine clearance ≥ 60 mL/min, calculated using the Cockcroft-Gault formula.; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (participants with Gilbert's syndrome may be allowed up to 3 × ULN);Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5.0 × ULN for participants with liver metastasis).\n\n      3\\) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy).\n9. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose. Participants must agree to use effective contraception from the time of signing the ICF until 7 months after the last study treatment dose (14 months after the last dose of cisplatin for female participants, and 11 months for male participants). Female participants shall not be breastfeeding during this period, and male participants must refrain from sperm donation\n10. Provides voluntary written informed consent after adequate understanding of the clinical trial.\n\nExclusion Criteria:\n\n1. Patients with leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active CNS metastasis. Patients with supratentorial and/or cerebellar metastases (i.e., no midbrain, pons, or medulla oblongata involvement) may be enrolled if they have received local therapy, have achieved disease stability at least 2 weeks prior to the first dose of study intervention (no new brain metastases or enlargement of pre-existing brain metastatic lesions on imaging, all neurologic symptoms stabilized or returned to normal), and require no glucocorticoid treatment or receive prednisone at a daily dose ≤10 mg or equivalent doses of other glucocorticoids.\n2. History of other malignant neoplasms within 3 years prior to the first dose of study intervention, except for the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, etc.\n3. Known hypersensitivity to study drugs, any components of PD-1 inhibitors/gemcitabine/cisplatin, or humanized monoclonal antibody products.\n4. Prior treatment with antibody-drug conjugates (ADCs) carrying topoisomerase I inhibitor payloads.\n5. Adverse events from prior anti-tumor therapy that have not recovered to Grade ≤1 per NCI-CTCAE v6.0 (except for toxicities judged by the investigator to pose no safety risk such as alopecia); patients who experienced Grade ≥3 immune-related adverse events (irAEs) during prior therapy, or who permanently discontinued treatment due to irAEs\n6. Participants who fail to meet the required washout periods will be excluded.\n7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose of study intervention, including but not limited to:\n\n   1. Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias requiring intervention, third-degree atrioventricular block, etc.; Fridericia-corrected QT interval \\>470 ms (Fridericia formula: QTcF=QT/RR⁰·³³, RR=60/heart rate);\n   2. History of myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass graft surgery;\n   3. New York Heart Association (NYHA) class Ⅱ or higher heart failure, or left ventricular ejection fraction \\<50% on screening assessment;\n   4. Stroke or other grade ≥3 cardiovascular or cerebrovascular events;\n   5. Pulmonary embolism; known deep vein thrombosis requiring intervention as judged by the investigator.\n8. Prior history of ILD / non-infectious pneumonitis requiring glucocorticoid treatment, current ILD / non-infectious pneumonitis, or ILD / non-infectious pneumonitis cannot be ruled out on screening imaging, or severe ventilatory dysfunction and/or impaired diffusion shown on pulmonary function test.\n9. Severe infection within 4 weeks prior to the first dose of study intervention, including but not limited to bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, etc.; active infection requiring systemic antibiotics within 2 weeks prior to the first dose of study intervention.\n10. Prior interruption of EGFR-targeted therapy for ≥1 month or permanent discontinuation due to skin toxicity, or current skin disease requiring oral or intravenous treatment.\n11. Participants with active autoimmune disease or history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc.). Participants with the following conditions may proceed for screening: well-controlled type 1 diabetes, well-controlled hypothyroidism requiring only hormone replacement therapy, skin disorders that do not require systemic treatment (such as vitiligo, psoriasis or alopecia), or participants whose disease is not expected to relapse in the absence of external triggers.\n12. Pleural, peritoneal or pericardial effusion requiring clinical intervention within 2 weeks prior to the first dose of study intervention.\n13. Active HBV or HCV infection (HBsAg positive with HBV-DNA ≥1×10⁴ copies/mL, or positive HCV antibody with HCV-RNA above the assay lower limit of detection), or HIV infection / diagnosed acquired immunodeficiency syndrome. Note: For HBsAg-positive subjects, antiviral therapy with nucleoside analogues such as entecavir or tenofovir disoproxil fumarate is recommended to be initiated before the first dose of study intervention.\n14. History of immunodeficiency (including positive HIV test, other acquired or congenital immunodeficiency diseases), or history of allogeneic stem cell or solid organ transplantation.\n15. Other conditions that, in the investigator's opinion, render the participant unsuitable for this clinical trial (e.g., psychiatric disorders, uncontrolled or poorly controlled hypertension and diabetes mellitus, etc.)","locations":[{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"Guangzhou","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Clinical Trials Information Group officer","phone":"031169085587","email":"ctr-contact@cspc.cn"}],"primaryOutcomes":["Progression Free Survival by Blinded Independent Central Review (BICR) based on RECIST v1.1."],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Phase 3: testing SYS6010 combined with Enlonstobart for Previously Systemic Treatment-Naive Recurrent or Metastatic Nasopharyngeal Carcinoma","inPlainEnglish":"This is a randomly assigned, open-label, multicenter phase Ⅲ trial to measure the how well it works and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-who have not tried this kind of treatment before recurrent or metastatic nasopharyngeal carcinoma","whoItsFor":["Ages 18 Years to 75 Years","Histologically confirmed recurrent or metastatic nasopharyngeal carcinoma, with no prior systemic therapy for recurrent or metastatic nasopharyngeal carcinoma","Willing to provide tumor tissue samples for testing of EGFR protein and PD-L1 expression. If sample collection is not feasible for certain reasons, eligibility will be determined by joint assessment of the investigator and sponsor","At least one measurable lesion confirmed by CT or MRI per RECIST v1.1. The lesion has not received prior radiotherapy, or has demonstrated clear progression after prior radiotherapy","Eastern Cooperative Oncology Group (ECOG) performance status 0-1","Expected survival of the participant is ≥ 3 months","Major organ function must meet the following criteria within 7 days prior to enrollment:","3\\) Coagulation function: i. Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (for participants not receiving anticoagulation therapy)"],"whoShouldSkip":["Known hypersensitivity to study drugs, any components of PD-1 inhibitors/gemcitabine/cisplatin, or humanized monoclonal antibody products","Prior treatment with antibody-drug conjugates (ADCs) carrying topoisomerase I inhibitor payloads","Participants who fail to meet the required washout periods will be excluded","History of severe cardiovascular and cerebrovascular diseases within 6 months prior to the first dose of study intervention, including but not limited to:","Severe cardiac rhythm or conduction abnormalities, such as clinically significant ventricular arrhythmias requiring intervention, third-degree atrioventricular block, etc.; Fridericia-corrected QT interval \\>470 ms (Fridericia formula: QTcF=QT/RR⁰·³³, RR=60/heart rate);","History of myocardial infarction, unstable angina, aortic dissection, angioplasty, or coronary artery bypass graft surgery;","New York Heart Association (NYHA) class Ⅱ or higher heart failure, or left ventricular ejection fraction \\<50% on screening assessment;"],"whatHappens":"If you join, the listed intervention(s) are SYS6010 combined with Enlonstobart, or Tislelizumab combined with chemotherapy. The registry lists allocation as na. This is a randomly assigned, open-label, multicenter phase Ⅲ trial to measure the how well it works and safety of SYS6010 combined with Enlonstobart injection versus Tislelizumab combined with chemotherapy (gemcitabine plus cisplatin) in patients with previously systemic treatment-who have not tried this kind of treatment before recurrent or metastatic nasopharyngeal carcinoma","phaseExplainer":"Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.","effort":"They plan to enroll about 424 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.330Z"},{"nctId":"NCT07925125","title":"Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions","officialTitle":"Artificial Intelligence-Assisted 4D Dynamic Long-Axial PET Imaging for the Detection of Early Pancreatic Cancer Lesions","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Ruijin Hospital","sponsorClass":"OTHER","summary":"Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression. Furthermore, leveraging the advantages of four-dimensional dynamic long-axial PET imaging, artificial intelligence-assisted lesion detection and analysis will be performed to characterize lesions and differentiate between benign and malignant lesions. The imaging findings will subsequently be compared with postoperative histopathological results to evaluate the diagnostic performance of the proposed imaging approaches.","conditions":["Pancreas Carcinoma","PDAC - Pancreatic Ductal Adenocarcinoma"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"PET/CT with 18F-FDG and 68Ga-FAPI"}],"enrollment":50,"startDate":"2024-11-15","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients with suspected pancreatic tumors larger than 1.0 cm.\n* No histopathological diagnosis available before enrollment.\n* No prior treatment for the suspected pancreatic tumor.\n* Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging.\n* Able and willing to provide written informed consent.\n* Willing and able to comply with the study procedures and follow-up requirements.\n* Male or female, aged 18-75 years.\n* In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures.\n\nExclusion Criteria:\n\n* Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment.\n* Pregnancy, suspected pregnancy, or breastfeeding.\n* Poor compliance with the study procedures.","locations":[{"facility":"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","city":"Shanghai","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Li","phone":"0086-021-64370045","email":"lb10363@rjh.com.cn"}],"primaryOutcomes":["Diagnostic Performance of Dynamic PET Imaging for Pancreatic Lesion Characterization"],"hasResults":false,"conditionSlugs":["pancreatic-cancer"],"drugSlugs":[],"locationSlugs":["shanghai-china"],"enrichment":{"headline":"Not a traditional drug phase: PET/CT with 18F-FDG and 68Ga-FAPI for Pancreas Carcinoma","inPlainEnglish":"Pancreatic ductal adenocarcinoma (PDAC) is associated with a poor prognosis, and early detection of pancreatic lesions is of great importance for improving patient outcomes. In this study, whole-body imaging with FDG and FAPI will be used to visualize the early development of pancreatic cancer lesions from multiple perspectives, including glucose metabolism, tumor fibrotic stroma, and integrin receptor expression.","whoItsFor":["Ages 18 Years to 75 Years","Patients with suspected pancreatic tumors larger than 1.0 cm","No histopathological diagnosis available before enrollment","No prior treatment for the suspected pancreatic tumor","Histopathological diagnosis obtained through surgery or biopsy within 2 months after PET imaging","Willing and able to comply with the study procedures and follow-up requirements","Male or female, aged 18-75 years","In generally good health, with an estimated life expectancy of more than 6 months and able to tolerate the imaging procedures"],"whoShouldSkip":["Severe concomitant diseases that, in the investigator's judgment, make participation in the study inappropriate, including severe cardiopulmonary dysfunction or severe hepatic or renal impairment","Pregnancy, suspected pregnancy, or breastfeeding","Poor compliance with the study procedures"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 50 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.438Z"},{"nctId":"NCT07925281","title":"Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder Using Eye-tracking, Physiological, and Interoceptive Measures (ERAD)","officialTitle":"Emotional Reactivity in Severe Alcohol Use Disorder and Major Depressive Disorder: a Multidimensional Approach Combining Dynamic Emotional Stimuli, Eye Tracking, Pupillometry, Electrodermal and Cardiac Activity, and Biological Measures of Stress and Interoception","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Université Catholique de Louvain","sponsorClass":"OTHER","summary":"The goal of this observational study is to investigate emotional recognition and emotional reactivity in individuals with severe Alcohol Use Disorder (sAUD), Major Depressive Disorder (MDD), comorbid sAUD and depressive symptoms (sAUD+DS), and healthy controls.\n\nThe main questions this study aims to answer are:\n\n* Do individuals with sAUD, MDD, sAUD+DS, and healthy controls exhibit different patterns of emotional recognition and emotional reactivity in response to dynamic emotional stimuli?\n* How are emotional recognition and emotional reactivity related to each other?\n* How are these emotional processes associated with psycho-affective, socio-emotional, stress-related, interoceptive, and disorder-specific factors?\n* Do emotional recognition and emotional reactivity predict clinical outcomes at 6- and 12-month follow-up assessments?\n\nParticipants will:\n\n* Complete two experimental sessions involving dynamic emotional facial expression and emotional scene tasks\n* Provide emotion identification, subjective emotional ratings (type, intensity, and valence), and and self-reported bodily sensations using an emotional body map (InteroMap)\n* Undergo eye-tracking, pupillometry, electrodermal activity, and cardiac activity recordings during emotional tasks\n* Complete questionnaires assessing psycho-affective, socio-emotional, stress-related, and disorder-specific factors\n* Provide saliva and hair samples for cortisol assessment\n* Participate in follow-up clinical assessments at 6 and 12 months\n\nResearchers will compare emotional recognition and emotional reactivity profiles across the sAUD, MDD, sAUD+DS, and healthy control groups, and evaluate their predictive value for future clinical outcomes.","conditions":["Alcohol Use Disorder","Major Depressive Disorder (MDD)"],"keywords":[],"interventions":[{"type":"OTHER","name":"Emotional Reactivity Experimental Protocol"}],"enrollment":280,"startDate":"2026-11-02","completionDate":"2028-09","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\nAll participants must:\n\n* Be aged 18 to 70 years, fluent in French, and able to provide written informed consent.\n* Have normal or corrected-to-normal vision, without ocular conditions that could interfere with eye-tracking or pupillometry data quality.\n\nPatients with severe Alcohol Use Disorder (sAUD)\n\n* Meet DSM-5 criteria for severe Alcohol Use Disorder.\n* Be tested during the third week of abstinence.\n* Have no history of neurological, endocrinal, or infectious disease, diagnosed anxiety or depressive disorder, or other substance use disorder (except tobacco).\n\nPatients with Major Depressive Disorder (MDD)\n\n* Meet DSM-5 criteria for a current Major Depressive Episode.\n* Have no history of neurological disease, severe alcohol use disorder, other substance use disorder (except tobacco), or other psychiatric disorders (e.g., bipolar disorder, schizophrenia).\n\nPatients with severe Alcohol Use Disorder and Depressive Symptoms (sAUD+DS)\n\n* Meet the same inclusion criteria as the sAUD group.\n* Present moderate to severe depressive symptoms persisting after withdrawal, confirmed by a clinical diagnosis using the Mini International Neuropsychiatric Interview (MINI).\n\nHealthy Controls (HC)\n\n* Recruited from the general population, matched to patients for age, sex, and education.\n* Have no current or past psychiatric or neurological disorder.\n* Present subclinical levels of alcohol consumption (AUDIT score \\<7 for men, \\<6 for women) and depressive symptoms (BDI-II score \\<10).\n\nExclusion Criteria:\n\n* Cognitive impairment, uncorrected visual deficits, or any condition preventing understanding of instructions or reliable task performance (e.g., major attention or comprehension difficulties);\n* Ophthalmological conditions that could compromise eye-tracking or pupillometry data quality;\n* Dermatological conditions or excessive sweating that may interfere with electrodermal and cardiac activity recording;\n* Cardiac conditions or devices that could affect ECG recording (e.g., pacemaker, defibrillator, severe uncontrolled arrhythmias), or use of medications strongly influencing heart rate.\n* Acute intoxication or withdrawal state at the time of testing;\n* Current diagnosis of psychotic disorder, bipolar disorder, or neurological disease;\n* Pregnancy;\n* Ongoing participation in another interventional or clinical study that could interfere with behavioral or physiological measures;\n* For healthy controls: use of psychotropic medication or history of substance use disorder.","locations":[{"facility":"Cliniques Universitaires Saint-Luc","city":"Brussels","state":"Belgium","country":"Belgium","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Edelweiss Touron, PhD","phone":"+32470052024","email":"edelweiss.touron@uclouvain.be"},{"name":"Pierre Maurage, PhD","phone":"+3210474804","email":"pierre.maurage@uclouvain.be"}],"primaryOutcomes":["Multidimensional assessment of emotional recognition and emotional reactivity to dynamic emotional stimuli"],"hasResults":false,"conditionSlugs":["als","depression"],"drugSlugs":[],"locationSlugs":["brussels-belgium"],"enrichment":{"headline":"Not a traditional drug phase: Emotional Reactivity Experimental Protocol for Alcohol Use Disorder","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to investigate emotional recognition and emotional reactivity in individuals with severe Alcohol Use Disorder (sAUD), Major Depressive Disorder (major depression), comorbid sAUD and depressive symptoms (sAUD+DS), and healthy controls. The main questions this study aims to answer are: * Do individuals with sAUD, major depression, sAUD+DS, and healthy controls exhibit different patterns of emotional recognition and emotional reactivity in response to dynamic emotional stimuli?","whoItsFor":["Ages 18 Years to 70 Years","All participants must:","Have normal or corrected-to-normal vision, without ocular conditions that could interfere with eye-tracking or pupillometry data quality","Patients with severe Alcohol Use Disorder (sAUD)","Meet DSM-5 criteria for severe Alcohol Use Disorder","Be tested during the third week of abstinence","Have no history of neurological, endocrinal, or infectious disease, diagnosed anxiety or depressive disorder, or other substance use disorder (except tobacco)","Patients with Major Depressive Disorder (major depression)"],"whoShouldSkip":["Cognitive impairment, uncorrected visual deficits, or any condition preventing understanding of instructions or reliable task performance (e.g., major attention or comprehension difficulties);","Ophthalmological conditions that could compromise eye-tracking or pupillometry data quality;","Dermatological conditions or excessive sweating that may interfere with electrodermal and cardiac activity recording;","Cardiac conditions or devices that could affect ECG recording (e.g., pacemaker, defibrillator, severe uncontrolled arrhythmias), or use of medications strongly influencing heart rate","Acute intoxication or withdrawal state at the time of testing;","Current diagnosis of psychotic disorder, bipolar disorder, or neurological disease;","Ongoing participation in another treatment or clinical study that could interfere with behavioral or physiological measures;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 280 people at Brussels. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:13.108Z"},{"nctId":"NCT07925307","title":"C2001P-CS6: Testing the Feasibility of Different HPV Screening and Care Strategies for Women Living With HIV","officialTitle":"C2001P-CS6 CASCADE: A Feasibility Study of HPV Screening and Management Strategies Utilizing Extended Molecular HPV DNA Genotyping and HPV Viral Load in Women Living With HIV","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"University of California, San Diego","sponsorClass":"OTHER","summary":"The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV. While there is consensus that women testing positive for HPV 16 and/or 18 should be immediately managed and treated, optimal management strategies for women with other hrHPV types (non-16/18) are not well defined.\n\nThis prospective cohort study will enroll WLWH undergoing cervical cancer screening using primary HPV testing. Women will self-collect vaginal specimens for hrHPV testing using the Abbott Alinity m HPV assay, which provides extended HPV genotyping and a proxy for HPV viral load based on cycle threshold (CT) values. Women with hrHPV detected will return for further evaluation and treatment as indicated. A subset of women will return at Month 6 for repeat evaluation.\n\nThe study will evaluate feasibility for a future trial by examining recruitment, retention, return for evaluation, and completion of treatment. It will also explore management strategies for women with non-16/18 hrHPV based on extended genotyping and HPV viral load compared to standard of care approaches using visual inspection with acetic acid (VIA).","conditions":["Human Papillomavirus (HPV)","HPV Associated Cancers","Cervical Cancer","Human Immunodeficiency Virus (HIV)","Cervical Intraepithelial Neoplasia (CIN)"],"keywords":[],"interventions":[{"type":"DIAGNOSTIC_TEST","name":"HPV DNA Testing (Abbott Alinity m HPV Assay)"},{"type":"PROCEDURE","name":"Visual Inspection with Acetic Acid"},{"type":"PROCEDURE","name":"Cervical Histology (Biopsy Procedures)"},{"type":"PROCEDURE","name":"Cervical Treatment (Thermal Ablation or LEEP/LLETZ)"}],"enrollment":750,"startDate":"2026-10-16","completionDate":"2027-12-31","sex":"FEMALE","minAge":"25 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* HIV-1 infection, as documented by:\n\n  1. any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR\n  2. a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR\n  3. documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages.\n* Aged 25 or older.\n* Ability to understand and the willingness to sign a written informed consent document by the participant or by the legal representative(s) of the participant.\n* Have an intact cervix.\n\nExclusion Criteria:\n\n* Current symptoms or concern for cervical cancer.\n* History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer.\n* Have undergone cervical hHSIL treatment in the past year.\n* Have a history of hysterectomy with removal of the cervix.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including opportunistic infections of AIDS and/or genitourinary infections), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n* Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators.","locations":[{"facility":"Kenya Medical Research Institute","city":"Nairobi","state":"","country":"Kenya","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Caique Mello, MPH","phone":"858-253-6394","email":"camello@health.ucsd.edu"}],"primaryOutcomes":["Proportion of Potentially Eligible Participants Providing Informed Consent","Time to Clinic Receipt of HPV Test Results","Percentage of Participants Receiving HPV Test Results","Proportion of Participants Returning for Baseline Evaluation","Proportion of Participants Retained for the Month 6 Visit","Proportion of Participants With Cervical HSIL Classified for Treatment"],"hasResults":false,"conditionSlugs":["cervical-cancer","als","hiv"],"drugSlugs":[],"locationSlugs":["nairobi-kenya"],"enrichment":{"headline":"Not a traditional drug phase: HPV DNA Testing (Abbott Alinity m HPV Assay) for Human Papillomavirus (HPV)","inPlainEnglish":"The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening. WLWH have a higher diversity of anogenital HPV types causing cervical high-grade squamous intraepithelial lesions (hHSIL) and invasive cancer compared to women without HIV.","whoItsFor":["Ages 25 Years to any","Women only","HIV-1 infection, as documented by:","any FDA-approved, licensed HIV rapid test performed in conjunction with screening (oral immunoblot, ELISA test kit, and confirmed by Western blot or other approved test), OR","a physician's written record that documents HIV infection with supporting information on the participant's relevant medical history and/or current management of HIV infection, OR","documentation of a prescription of an approved antiretroviral regimen by either possession of pill bottles or packages with prescriber's name or ARVs dispensed from an HIV clinical treatment program with participant identifiers affixed to the bottles or packages","Have an intact cervix"],"whoShouldSkip":["Current symptoms or concern for cervical cancer","History of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer or current symptoms of cervical, vulvar, vaginal, perianal, anal cancer or oral cancer","Have undergone cervical hHSIL treatment in the past year","Have a history of hysterectomy with removal of the cervix","Any other medical condition or social situation that would put the participant, the study staff, or the study outcomes at risk, as determined by the site investigators"],"whatHappens":"If you join, the listed intervention(s) are HPV DNA Testing (Abbott Alinity m HPV Assay), Visual Inspection with Acetic Acid, or Cervical Histology (Biopsy Procedures). The registry lists allocation as na. The overall goal of this study is to inform the design and establish feasibility for a future clinical trial to determine the optimal management of women living with HIV (WLWH) with high-risk human papillomavirus (hrHPV) detected on HPV-based cervical cancer screening.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 750 people at Nairobi. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.338Z"},{"nctId":"NCT07925450","title":"Iron Treatment for Iron Deficiency Anemia in Children and Young Adults With Crohn's Disease","officialTitle":"Developing and Validating a Predictive Model for the Management of Iron Deficiency Anemia in Pediatric Crohn's Disease Through Analysis of Microbiome and Patient Laboratory Data","status":"RECRUITING","phases":["PHASE4"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Weill Medical College of Cornell University","sponsorClass":"OTHER","summary":"Children and young adults with Crohn's disease may develop iron deficiency anemia, a condition in which low iron levels reduce the number of healthy red blood cells. This study aims to develop and test a model to help identify which iron treatment approached are most effective for these patients. Researchers will examine laboratory results, disease activity, treatment information, and information about bacteria in the digestive tract. Participants will be followed over time, and questionnaires will assess iron supplement use and related symptoms. The findings may help guide iron treatment for children and young adults with Crohn's disease.","conditions":["Crohn's Disease","Iron Deficiency Anemia"],"keywords":[],"interventions":[{"type":"DRUG","name":"Iron (ferrous sulfate)"}],"enrollment":150,"startDate":"2023-09-13","completionDate":"2029-03-13","sex":"ALL","minAge":"3 Years","maxAge":"21 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Male or female\n* 3 to 21 years of age\n* Biopsy confirmed Crohns disease involving gastric, duodenal, and/or jejunal mucosa\n* Quiescent Crohns disease, assessed by histopathology, CRP, ESR, and PCDAI scores\n* Iron deficiency anemia, defined as hemoglobin or transferrin saturation below age-defined norms and/or MCV \\<80.\n\nExclusion Criteria:\n\n* antibiotic use with 6 weeks of endoscopic evaluation","locations":[{"facility":"Weill Cornell Medicine","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Median Hemoglobin Level","Median MCV (Mean Corpuscular Volume)","Median Serum Iron Level","Median Iron Saturation","Median Ferritin Level"],"hasResults":false,"conditionSlugs":["crohns-disease"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Phase 4: testing Iron (ferrous sulfate) for Crohn's Disease","inPlainEnglish":"Children and young adults with Crohn's disease may develop iron deficiency anemia, a condition in which low iron levels reduce the number of healthy red blood cells. This study aims to develop and test a model to help identify which iron treatment approached are most effective for these patients.","whoItsFor":["Ages 3 Years to 21 Years","3 to 21 years of age","Biopsy confirmed Crohns disease involving gastric, duodenal, and/or jejunal mucosa","Quiescent Crohns disease, assessed by histopathology, a blood inflammation marker (CRP), ESR, and PCDAI scores","Iron deficiency anemia, defined as hemoglobin or transferrin saturation below age-defined norms and/or MCV \\<80"],"whoShouldSkip":["antibiotic use with 6 weeks of endoscopic evaluation"],"whatHappens":"If you join, the listed intervention(s) are Iron (ferrous sulfate). The registry lists allocation as randomized. Children and young adults with Crohn's disease may develop iron deficiency anemia, a condition in which low iron levels reduce the number of healthy red blood cells.","phaseExplainer":"Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.","effort":"They plan to enroll about 150 people at New York. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:15.887Z"},{"nctId":"NCT07925554","title":"Interferon-α Maintenance in Favorable-Risk AML","officialTitle":"Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Peking University People's Hospital","sponsorClass":"OTHER","summary":"Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern. Interferon-alpha (IFN-α) may help prevent relapse, but its effectiveness as maintenance therapy has not been confirmed in prospective studies.\n\nThis prospective, single-arm study aims to evaluate the efficacy and safety of IFN-α as maintenance therapy in patients with favorable-risk AML. Participants will receive IFN-α maintenance treatment and will be followed for disease relapse, survival, and treatment-related adverse events.","conditions":["AML (Acute Myeloid Leukemia)"],"keywords":[],"interventions":[{"type":"BIOLOGICAL","name":"pegylated interferon alfa-2b"}],"enrollment":30,"startDate":"2026-03-28","completionDate":"2027-10-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 18-70 years, inclusive.\n2. Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification.\n3. Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy.\n4. Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).\n5. Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) \\<0.1% and/or a \\>3-log reduction in molecular disease burden.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment.\n8. Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment.\n\n   \\-\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL).\n2. Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.\n3. Uncontrolled active infection.\n4. Severe organ failure.\n5. Pregnancy.\n6. Unwillingness to receive interferon therapy.\n7. History of hyperthyroidism or hypothyroidism.\n8. Participation in another clinical study within 1 month before enrollment. -","locations":[{"facility":"Peking University People's Hospital","city":"Beijing","state":"","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yuanjie Ding","phone":"010-88325948","email":"rmkyc@163.com"},{"name":"Fei-fei Tang","phone":"86-13521893860","email":"bjmugirl@163.com"}],"primaryOutcomes":["2-Year Cumulative Incidence of Relapse"],"hasResults":false,"conditionSlugs":["leukemia"],"drugSlugs":[],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 2: testing pegylated interferon alfa-2b for AML (Acute Myeloid Leukemia)","inPlainEnglish":"Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern.","whoItsFor":["Ages 18 Years to 70 Years","Age 18-70 years, inclusive","Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification","Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy","Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC)","Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) \\<0.1% and/or a \\>3-log reduction in molecular disease burden","Eastern Cooperative Oncology Group (ECOG) performance status of 0-2","Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment"],"whoShouldSkip":["Acute promyelocytic leukemia (APL)","Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation","Uncontrolled active infection","Severe organ failure","Unwillingness to receive interferon therapy","History of hyperthyroidism or hypothyroidism","Participation in another clinical study within 1 month before enrollment. -"],"whatHappens":"If you join, the listed intervention(s) are pegylated interferon alfa-2b. The registry lists allocation as na. Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 30 people at Beijing. Taking part typically means an infusion or injection of a biologic plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.837Z"},{"nctId":"NCT07925684","title":"Determination of ED90 of Remimazolam Besylate Combined With Alfentanil for Gastroscopy Sedation in Obese Patients","officialTitle":"ED₉₀ of Remimazolam Besylate Combined With Different Doses of Alfentanil for Inhibiting Gastroscopic Insertion Reactions in Obese Patients: A Dose-Finding Trial With Biased-Coin Sequential Allocation","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"QUADRUPLE","sponsor":"Jianbo Wu","sponsorClass":"OTHER","summary":"This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients. We will use a biased coin up-and-down sequential design to identify the 90% effective dose (ED90). Sedation effect and safety will be assessed. All participants will have standard monitoring during the procedure, and any adverse events will be closely watched.","conditions":["Procedural Sedation and Analgesia","Obesity & Overweight"],"keywords":["Gastroscopy","Remimazolam besylate","Alfentanil"],"interventions":[{"type":"DRUG","name":"Alfentanil Hydrochloride Injection"},{"type":"DRUG","name":"Remimazolam Besylate for Injection"}],"enrollment":120,"startDate":"2026-04-20","completionDate":"2026-11","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged 18 to 65 years\n* Body mass index (BMI) between 30 and 39.9 kg/m²\n* American Society of Anesthesiologists physical status grade I-II or stable grade III\n\nExclusion Criteria:\n\n* Allergic to benzodiazepines and opioids\n* Refusal of anesthesia\n* Use of opioids or benzodiazepines within the past 6 months\n* History of alcohol abuse\n* Uncontrolled severe hypertension (systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg)\n* Recent respiratory infection, or a history of asthma, chronic obstructive pulmonary disease (COPD), or other respiratory diseases\n* Liver dysfunction (Child-Pugh B or higher); chronic kidney disease stage 3-5\n* History of cardiovascular disease\n* Psychiatric disorders or inability to communicate effectively\n* Pyloric obstruction, achalasia, or a history of upper gastrointestinal surgery; or scheduled for complex or therapeutic gastroscopy\n* Anticipated difficult airway","locations":[{"facility":"The First Affiliated Hospital of Shandong First Medical University","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Xiao Song","phone":"+86 15628773255","email":"songxiao0364@163.com"},{"name":"Jianbo Wu","phone":"","email":"jianbowu@126.com"}],"primaryOutcomes":["The primary outcome is the ED90 (90% effective dose) of remimazolam besylate combined with alfentanil for suppressing the gastroscopic insertion response in obese patients."],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":[],"locationSlugs":["jinan-china"],"enrichment":{"headline":"Not a traditional drug phase: testing Alfentanil Hydrochloride Injection for Procedural Sedation and Analgesia","inPlainEnglish":"This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients. We will use a biased coin up-and-down sequential design to identify the 90% effective dose (ED90).","whoItsFor":["Ages 18 Years to 65 Years","Patients aged 18 to 65 years","Body mass index (body-mass index (BMI)) between 30 and 39.9 kg/m²","American Society of Anesthesiologists physical status grade I-II or stable grade III"],"whoShouldSkip":["Allergic to benzodiazepines and opioids","Refusal of anesthesia","Use of opioids or benzodiazepines within the past 6 months","History of alcohol abuse","Uncontrolled severe hypertension (systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg)","Recent respiratory infection, or a history of asthma, chronic obstructive pulmonary disease (COPD), or other respiratory diseases","Liver dysfunction (Child-Pugh B or higher); chronic kidney disease stage 3-5"],"whatHappens":"If you join, the listed intervention(s) are Alfentanil Hydrochloride Injection, or Remimazolam Besylate for Injection. The registry lists allocation as randomized. This study aims to find the suitable dose of remimazolam combined with alfentanil for sedation during gastroscopy in obese patients.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 120 people at Jinan. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.830Z"},{"nctId":"NCT07926347","title":"Functional Reorganization and Recovery of the Language and Domain-general Multiple Demand Systems in Aphasia","officialTitle":"Functional Reorganization and Recovery of the Language and Domain-general Multiple Demand Systems in Aphasia","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Boston University Charles River Campus","sponsorClass":"OTHER","summary":"The objective of this study is to apply state-of-the art brain imaging approaches to evaluate new hypotheses about the contributions of core linguistic vs. domain-general executive systems to language processing and recovery in patients with varying degrees of linguistic impairment. Specifically, the investigators will first characterize the degree to which standard language assessments tax the domain-general Multiple Demand (MD) network (Aim 1). And then systematically investigate the causal contributions of the language and the MD networks to language processing and aphasia recovery in patients of varying severity (Aims 2 and 3).","conditions":["Aphasia"],"keywords":["Constant Therapy program","Psychotherapy","Lifestyle counseling","Lesion load"],"interventions":[{"type":"BEHAVIORAL","name":"Constant Therapy program"}],"enrollment":100,"startDate":"2026-12","completionDate":"2031-07","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* at least 12 weeks post-stroke at time of study enrolment\n* medically and neurologically stable (no active seizures for 6 months) and at least wheelchair ambulatory\n* premorbid fluency in English\n* a family member or caregiver available to assist in study setup and in communicating with study staff\n\nExclusion Criteria:\n\n* a major, active neurological condition other than stroke, as determined by medical record review\n* history of cognitive impairment unrelated to stroke, such as dementia\n* history of symptomatic stroke prior to index stroke\n* severe uncorrected vision and/or hearing problems likely to impact study participation\n* comorbid learning or language disorder diagnosed prior to stroke or as a child","locations":[{"facility":"Center for Brain Recovery, BU Charles River Campus","city":"Boston","state":"Massachusetts","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Swathi Kiran, PhD","phone":"617-358-5478","email":"kirans@bu.edu"}],"primaryOutcomes":["Change in the Western Aphasia Battery Revised Aphasia Quotient"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["boston-massachusetts"],"enrichment":{"headline":"Not a traditional drug phase: Constant Therapy program for Aphasia","inPlainEnglish":"The objective of this study is to apply state-of-the art brain imaging approaches to evaluate new hypotheses about the contributions of core linguistic vs. domain-general executive systems to language processing and recovery in patients with varying degrees of linguistic impairment.","whoItsFor":["Ages 18 Years to 80 Years","at least 12 weeks post-stroke at time of study enrolment","medically and neurologically stable (no active seizures for 6 months) and at least wheelchair ambulatory","premorbid fluency in English","a family member or caregiver available to assist in study setup and in communicating with study staff"],"whoShouldSkip":["a major, active neurological condition other than stroke, as determined by medical record review","history of cognitive impairment unrelated to stroke, such as dementia","history of symptomatic stroke prior to index stroke","severe uncorrected vision and/or hearing problems likely to impact study participation","comorbid learning or language disorder diagnosed prior to stroke or as a child"],"whatHappens":"If you join, the listed intervention(s) are Constant Therapy program. The registry lists allocation as randomized. The objective of this study is to apply state-of-the art brain imaging approaches to evaluate new hypotheses about the contributions of core linguistic vs.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 100 people at Boston. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.440Z"},{"nctId":"NCT07927244","title":"Improving Rural Endometrial Cancer Care","officialTitle":"Patient Navigation in Gynecologic Oncology: Improving Care Among Marginalized Endometrial Cancer Patients","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"UNC Lineberger Comprehensive Cancer Center","sponsorClass":"OTHER","summary":"This is a pilot feasibility study to enable intensive outreach for marginalized patients with endometrial cancer (EC). Rural residents as well as patients who self-identify as Black or African American patients with EC have higher mortality rates. This study aims to introduce a treatment focused patient navigation intervention for marginalized patients with EC to address the multiple barriers these patients face. Patient navigation is a personalized program to help patients navigate the health care system and access medical and non-medical services. For example, patient navigators can provide services such as mediating/facilitating communication between patients and their providers/health care team, advocating for patient needs, identifying financial assistance and insurance-related resources, coordinating complex patient care, and providing patients with psychosocial support. This study will assess the implementation and effectiveness of a navigation intervention targeting multilevel barriers to care. The primary objective is to evaluate the fidelity of following the patient navigation intervention protocol.","conditions":["Endometrial Cancer"],"keywords":["patient navigation","personalized program"],"interventions":[{"type":"BEHAVIORAL","name":"The patient-navigation program"}],"enrollment":50,"startDate":"2025-05-09","completionDate":"2026-12-23","sex":"FEMALE","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures.\n* Age ≥ 18 years at the time of consent.\n* Resides in a \\>25 miles between a patient's home and University of North Carolina Hospital\n* patients who self-identify as Black or African American race\n* Newly diagnosed or recurrent diagnosis of endometrial cancer undergoing treatment planning at University of North Carolina\n\nExclusion Criteria:\n\n* Patients who are not receiving treatment within the UNC health care system\n* Non-English-speaking patients","locations":[{"facility":"University of North Carolina at Chapel Hill, Department of Radiation Oncology","city":"Chapel Hill","state":"North Carolina","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kacee Little","phone":"919-984-0000","email":"kacee_little@med.unc.edu"}],"primaryOutcomes":["Fidelity of the navigation intervention"],"hasResults":false,"conditionSlugs":["endometrial-cancer"],"drugSlugs":[],"locationSlugs":["chapel-hill-north-carolina"],"enrichment":{"headline":"Not a traditional drug phase: The patient-navigation program for Endometrial Cancer","inPlainEnglish":"This is a pilot feasibility study to enable intensive outreach for marginalized patients with endometrial cancer (EC). Rural residents as well as patients who self-identify as Black or African American patients with EC have higher mortality rates.","whoItsFor":["Ages 18 Years to any","Women only","Age ≥ 18 years at the time of consent","Resides in a \\>25 miles between a patient's home and University of North Carolina Hospital","patients who self-identify as Black or African American race","Newly diagnosed or recurrent diagnosis of endometrial cancer undergoing treatment planning at University of North Carolina"],"whoShouldSkip":["Patients who are not receiving treatment within the UNC health care system","Non-English-speaking patients"],"whatHappens":"If you join, the listed intervention(s) are The patient-navigation program. The registry lists allocation as na. This is a pilot feasibility study to enable intensive outreach for marginalized patients with endometrial cancer (EC).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 50 people at Chapel Hill. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:08.686Z"},{"nctId":"NCT07927283","title":"Fulvic Acid Supplementation and Metabolic Syndrome","officialTitle":"Evaluation of Fulvic Acid Supplementation for the Attenuation of Symptoms Associated With Metabolic Syndrome","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"DOUBLE","sponsor":"Arizona State University","sponsorClass":"OTHER","summary":"Fulvic acid is a naturally occurring compound derived from the decomposition of organic matter in soil over long periods. Fulvic acid complexes, such as MLG-50 (MLG-50® Mineral Logic, Kalamazoo, Michigan), offer a highly concentrated, water-soluble form of fulvic acid that contains over 70 trace minerals and elements. Our preclinical studies have found that a soil derived organic mineral complex rich in fulvic acid prevented the high fat diet induced hyperglycemia, endothelial dysfunction, liver injury, endotoxemia, and gut dysbiosis induced by high-fat feeding in rats. We propose to examine the efficacy of fulvic acid (both 50 mg and 100 mg daily for 12 weeks) in the mitigation of symptoms related to metabolic syndrome.","conditions":["Metabolic Syndrome"],"keywords":["Fulvic acid","Metabolic syndrome","Pre-diabetes"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"fulvic acid"},{"type":"DIETARY_SUPPLEMENT","name":"fulvic acid"},{"type":"OTHER","name":"Placebo"}],"enrollment":60,"startDate":"2026-11-06","completionDate":"2027-11-15","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* metabolic syndrome or prediabetes\n\nExclusion Criteria:\n\n* pregnant or nursing\n* multiple medications to treat obesity, heart disease, thyroid conditions, cancer\n* smokers\n* competing athletes\n* vegetarians","locations":[{"facility":"PBC 850 N 5th Street","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol Johnston, PhD","phone":"6024963463","email":"carol.johnston@asu.edu"},{"name":"Karen Sweazea, PhD","phone":"4809656025","email":"karen.sweazea@asu.edu"}],"primaryOutcomes":["girth","hypertension","hyperglycemia","hypertriglyceridemia","cholesterol"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona"],"enrichment":{"headline":"Not a traditional drug phase: fulvic acid for Metabolic Syndrome","inPlainEnglish":"Fulvic acid is a naturally occurring compound derived from the decomposition of organic matter in soil over long periods. Fulvic acid complexes, such as MLG-50 (MLG-50® Mineral Logic, Kalamazoo, Michigan), offer a highly concentrated, water-soluble form of fulvic acid that contains over 70 trace minerals and elements.","whoItsFor":["Ages 18 Years to 65 Years","metabolic syndrome or prediabetes"],"whoShouldSkip":["pregnant or nursing","multiple medications to treat obesity, heart disease, thyroid conditions, cancer"],"whatHappens":"If you join, the listed intervention(s) are fulvic acid, fulvic acid, or Placebo. The registry lists allocation as randomized. Fulvic acid is a naturally occurring compound derived from the decomposition of organic matter in soil over long periods.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Phoenix. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.343Z"},{"nctId":"NCT07927296","title":"Vinegar and Heartburn","officialTitle":"Examining the Efficacy of Vinegar for Reducing Heartburn Symptoms Related to Gastroesophageal Reflux Disease (GERD)","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"CROSSOVER","masking":"NONE","sponsor":"Arizona State University","sponsorClass":"OTHER","summary":"In this study, a popular home remedy, vinegar, will be tested for its efficacy to relieve the discomfort of heartburn possibly by inducing the esophageal clearing mechanisms. We plan to recruit 22 individuals who report regular heartburn, but not diagnosed with erosive reflux disease, for this randomized crossover trial. Enrolled participants will identify foods that consistently cause their heartburn, and two of these foods will be prepared and consumed during their visits. Participants will arrive at the testing center on two occasions following a 4-h fast (no food or beverage except water) and consume the targeted foods in a 10-minute period. On one visit liquid vinegar will be ingested with the meal, and on the other visit (order of visits will be randomly determined) a vinegar tablet (control) will be ingested with the meal. Starting prior to food ingestion and for 2 hours post meal, symptoms will be assessed at 10-to-15-minute intervals by the participant using a validated heartburn severity scale.","conditions":["Heartburn"],"keywords":["vinegar","heartburn"],"interventions":[{"type":"DIETARY_SUPPLEMENT","name":"Vinegar"},{"type":"DIETARY_SUPPLEMENT","name":"vinegar pill"}],"enrollment":22,"startDate":"2026-11-16","completionDate":"2027-05-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* report heartburn symptoms two or more times a week for several weeks or months\n* Any over the counter PPI use (proton-pump inhibitors such as Prilosec, Nexium, Prevacid) will need to be restricted for one month.\n\nExclusion Criteria:\n\n* Drug use (prescription, over-the-counter, or otherwise) known to affect the stomach and digestive processes, including GLP-1 RA or GLP/GIP medications\n* Medical conditions that impact normal functioning of the gastrointestinal tract (e.g., Crohn's disease, Celiac disease, short bowel syndrome, ostomy, lactose intolerance, hernia , SIBO, H. Pylori positive hasn't been cleared etc.).\n* Excess alcohol use (\\>2 servings daily)","locations":[{"facility":"Arizona Biomedical Collaborative","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Carol Johnston, PhD","phone":"6024963463","email":"carol.johnston@asu.edu"}],"primaryOutcomes":["heartburn symptoms"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["phoenix-arizona"],"enrichment":{"headline":"Not a traditional drug phase: Vinegar for Heartburn","inPlainEnglish":"In this study, a popular home remedy, vinegar, will be tested for its how well it works to relieve the discomfort of heartburn possibly by inducing the esophageal clearing mechanisms. We plan to recruit 22 individuals who report regular heartburn, but not diagnosed with erosive reflux disease, for this randomly assigned crossover trial.","whoItsFor":["Ages 18 Years to any","report heartburn symptoms two or more times a week for several weeks or months","Any over the counter PPI use (proton-pump inhibitors such as Prilosec, Nexium, Prevacid) will need to be restricted for one month"],"whoShouldSkip":["Drug use (prescription, over-the-counter, or otherwise) known to affect the stomach and digestive processes, including GLP-1 RA or GLP/GIP medications","Medical conditions that impact normal functioning of the gastrointestinal tract (e.g., Crohn's disease, Celiac disease, short bowel syndrome, ostomy, lactose intolerance, hernia , SIBO, H. Pylori positive hasn't been cleared etc.)","Excess alcohol use (\\>2 servings daily)"],"whatHappens":"If you join, the listed intervention(s) are Vinegar, or vinegar pill. The registry lists allocation as randomized. In this study, a popular home remedy, vinegar, will be tested for its how well it works to relieve the discomfort of heartburn possibly by inducing the esophageal clearing mechanisms.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 22 people at Phoenix. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.352Z"},{"nctId":"NCT07927413","title":"Effectiveness and Safety of TachoSil® Fibrin Sealant Patch for Supporting Dural Sealing Among Adult Inpatients","officialTitle":"Effectiveness and Safety of TachoSil® Fibrin Sealant Patch in Comparison to a Hydrogel Sealant for Supporting Dural Sealing Among Adult Inpatients in the United States: A Retrospective, Non-Inferiority, Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Corza Medical GmbH","sponsorClass":"INDUSTRY","summary":"This retrospective observational cohort study compares the effectiveness and safety of adjunctive TachoSil® fibrin sealant patch with DuraSeal® hydrogel sealant for supporting dural sealing in adult patients undergoing cranial or spinal surgery at participating United States hospitals. Medical records will be reviewed to assess clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele within 90 days after surgery. The study will use 1:1 propensity score matching to evaluate whether TachoSil® is non-inferior to DuraSeal® and will assess additional effectiveness and safety outcomes.","conditions":["Cerebrospinal Fluid (CSF) Leak","Psuedomeningocele"],"keywords":["TachoSil®","DuraSeal® sealant"],"interventions":[{"type":"DRUG","name":"TachoSil®"},{"type":"DEVICE","name":"DuraSeal®"}],"enrollment":600,"startDate":"2026-02-13","completionDate":"2026-11-16","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged ≥ 18 years\n* Had an inpatient encounter to select sites with a cranial or spinal neurological surgery that involves dural sealing performed and discharged during January 1, 2017, and March 31, 2026\n* Had use of TachoSil® or DuraSeal® sealants during the cranial or spinal neurological surgery as supportive dural sealing method\n\nNote: Any surgery meeting the above criteria is considered index surgery\n\nExclusion Criteria:\n\n* Index surgery was trauma-related\n* Had an infection within 7 days prior to index date\n* Had any neurosurgery involving dural opening during the 12-month look-back period\n* Had neoplasm of dura mater/meningioma, requiring resection of dura during index visit (the earliest visit meeting selection criteria) or 12-month look-back period\n* Was pregnant at index visit\n* Had a CSF leak during the 12-month look-back period\n* If the surgical approach was transbasal or transpetrosal, if the arachnoid membrane and CSF- containing system remained intact, or if there was \\>1 dura opening (excluding extra ventricular or lumbar drains) during index surgery\n* Had use of Evarrest patch, Tisseel, Adherus, CraniSeal, Duragen, fibrin glue or other dural sealing products during index surgery\n* Had radiation therapy to surgical field in the 3 months prior to index date\n* Had chronic corticosteroid use in the 3 months prior to index date\n* Had both TachoSil® and DuraSeal® used for dural closure during index neurological surgery","locations":[{"facility":"Johns Hopkins University","city":"Baltimore","state":"Maryland","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Columbia University","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"University of Cincinnati College of Medicine","city":"Cincinnati","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Thomas Jefferson University","city":"Philadelphia","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Alleghany Health Network","city":"Pittsburgh","state":"Pennsylvania","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Swedish Health Services","city":"Seattle","state":"Washington","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jeff Wilson","phone":"416-578-9058","email":"Jeff.Wilson@corza.com"},{"name":"Michele Young","phone":"1 689-316-8809","email":"Michele.young@corza.com"}],"primaryOutcomes":["Risk of Clinically Evident CSF Leak or Clinically Evident Pseudomeningocele"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["baltimore-maryland","new-york-new-york","cincinnati-ohio","philadelphia-pennsylvania","pittsburgh-pennsylvania","seattle-washington"],"enrichment":{"headline":"Not a traditional drug phase: testing TachoSil® for Cerebrospinal Fluid (CSF) Leak","inPlainEnglish":"This retrospective watch-and-measure (no experimental treatment required) cohort study compares the effectiveness and safety of added on top of your current treatment TachoSil® fibrin sealant patch with DuraSeal® hydrogel sealant for supporting dural sealing in adult patients undergoing cranial or spinal surgery at participating United States hospitals. Medical records will be reviewed to assess clinically evident cerebrospinal fluid leak or clinically evident pseudomeningocele within 90 days after surgery.","whoItsFor":["Ages 18 Years to any","Had an inpatient encounter to select sites with a cranial or spinal neurological surgery that involves dural sealing performed and discharged during January 1, 2017, and March 31, 2026","Had use of TachoSil® or DuraSeal® sealants during the cranial or spinal neurological surgery as supportive dural sealing method","Note: Any surgery meeting the above criteria is considered index surgery"],"whoShouldSkip":["Index surgery was trauma-related","Had an infection within 7 days prior to index date","Had any neurosurgery involving dural opening during the 12-month look-back period","Had neoplasm of dura mater/meningioma, requiring resection of dura during index visit (the earliest visit meeting selection criteria) or 12-month look-back period","Was pregnant at index visit","Had a CSF leak during the 12-month look-back period","If the surgical approach was transbasal or transpetrosal, if the arachnoid membrane and CSF- containing system remained intact, or if there was \\>1 dura opening (excluding extra ventricular or lumbar drains) during index surgery"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 600 people at 6 sites. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:29.775Z"},{"nctId":"NCT07927439","title":"Investigating the Impact of Treadmill-integrated Virtual Reality Training on Walking Outside the Clinic","officialTitle":"Investigating the Acute and Long-term Effects of Treadmill-integrated Virtual Reality (VR) Training on Real-World Mobility and Fall-Related Outcomes in People With Multiple Sclerosis","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Shepherd Center, Atlanta GA","sponsorClass":"OTHER","summary":"This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program. The study will also track changes in balance, fatigue, fall risk, fear of falling, confidence with walking, and overall quality of life.","conditions":["Multiple Sclerosis"],"keywords":["walking","gait","fear of falling","balance","spatiotemporal metrics","treadmill training","virtual reality"],"interventions":[{"type":"OTHER","name":"Treadmill-integrated virtual reality gait training"}],"enrollment":10,"startDate":"2026-07-31","completionDate":"2027-04-27","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Have a clinically confirmed diagnosis of multiple sclerosis (MS).\n* Be 18 years of age or older.\n* Demonstrate ≥10% variability in stride length, step length, or gait asymmetry.\n* Can ambulate without an assistive device, with a unilateral, or with a bilateral assistive device.\n* Demonstrate no more than mild cognitive impairment, indicated by the Mini-Mental State Exam (score \\>19).\n* Possess adequate cognitive function to understand and follow research instructions.\n* Be able to safely participate in the study and training procedures as determined by study staff.\n* Be fluent in English and able to communicate discomfort, fatigue, or pain in English.\n* Be able to travel to Shepherd Center to complete key assessment points in-person and for in-person training sessions twice per week.\n\nExclusion Criteria:\n\n* Have a diagnosis of any other neurological condition or recent orthopedic conditions that affects gait, balance, or mobility.\n* Exhibit \\<10% variability in stride length, step length, or gait asymmetry.\n* Are unable to ambulate (i.e. wheelchair bound or bedbound individuals).\n* Have legal blindness or severe visual impairment that would interfere with virtual reality engagement or safe ambulation.\n* Have a body weight exceeding 300 lbs., which exceeds the safety limits of the treadmill and body weight support system.\n* Have uncontrolled or untreated hypertension, hypotension, or angina.\n* Have a past or current history of epilepsy or any other type of seizure disorder, whether controlled or uncontrolled.\n* Have undergone major surgery within the past 6 months or hospitalization within the past 3 months.","locations":[{"facility":"Shepherd Center","city":"Atlanta","state":"Georgia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Julie F Stowell, DPT","phone":"4046035049","email":"julie.stowell@shepherd.org"}],"primaryOutcomes":["Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait","Spatiotemporal metrics of gait"],"hasResults":false,"conditionSlugs":["multiple-sclerosis","als"],"drugSlugs":[],"locationSlugs":["atlanta-georgia"],"enrichment":{"headline":"Not a traditional drug phase: Treadmill-integrated virtual reality gait training for Multiple Sclerosis","inPlainEnglish":"This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS). Participants will complete a 6-week training program and wear smart socks that measure how they walk before, during, and after the program.","whoItsFor":["Ages 18 Years to any","Have a clinically confirmed diagnosis of multiple sclerosis (MS)","Be 18 years of age or older","Demonstrate ≥10% variability in stride length, step length, or gait asymmetry","Can ambulate without an assistive device, with a unilateral, or with a bilateral assistive device","Demonstrate no more than mild cognitive impairment, indicated by the Mini-Mental State Exam (score \\>19)","Possess adequate cognitive function to understand and follow research instructions","Be able to safely participate in the study and training procedures as determined by study staff"],"whoShouldSkip":["Have a diagnosis of any other neurological condition or recent orthopedic conditions that affects gait, balance, or mobility","Exhibit \\<10% variability in stride length, step length, or gait asymmetry","Are unable to ambulate (i.e. wheelchair bound or bedbound individuals)","Have legal blindness or severe visual impairment that would interfere with virtual reality engagement or safe ambulation","Have a body weight exceeding 300 lbs., which exceeds the safety limits of the treadmill and body weight support system","Have uncontrolled or untreated hypertension, hypotension, or angina","Have a past or current history of epilepsy or any other type of seizure disorder, whether controlled or uncontrolled"],"whatHappens":"If you join, the listed intervention(s) are Treadmill-integrated virtual reality gait training. The registry lists allocation as na. This study will test whether a treadmill-based virtual reality walking program is safe, practical, and helpful for people with multiple sclerosis (MS).","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Atlanta. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:09.969Z"},{"nctId":"NCT07927452","title":"Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma","officialTitle":"Anatomic Versus Non-anatomic Liver Resection After Successful Immune Checkpoint Inhibitor-Based Conversion Therapy for Initially Unresectable Hepatocellular Carcinoma: A Prospective Cohort Study","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Sun Yat-sen University","sponsorClass":"OTHER","summary":"This prospective observational cohort study will compare the survival outcomes of anatomic liver resection (ALR) versus nonanatomic liver resection (NALR) in patients with initially unresectable hepatocellular carcinoma (HCC) who become eligible for resection following immune checkpoint inhibitor (ICI)-based conversion therapy. Emerging evidence suggests that surgical resection may provide a survival benefit for selected patients with initially unresectable HCC after conversion therapy; however, the optimal surgical approach for these patients remains unclear. This study aims to inform surgical decision-making in this setting. Participants will be included in one of two cohorts according to the procedure received: ALR or NALR. The primary outcome is the 2-year recurrence-free survival (RFS) rate. Participants will undergo regular imaging assessments and survival follow-up. The target enrollment is 874 participants, with approximately 437 planned for each cohort; because treatment allocation is not randomized, the actual cohort sizes may differ.","conditions":["Hepato Cellular Carcinoma (HCC)","Liver Resection","Conversion Therapy"],"keywords":[],"interventions":[],"enrollment":874,"startDate":"2026-10-25","completionDate":"2030-12-31","sex":"ALL","minAge":"18 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Clinical diagnosis of initially unresectable HCC\n* Received conversion therapy based on PD-1/PD-L1 therapy.\n* Two liver surgeons with associate senior or higher professional titles determine that R0 resection is feasible after conversion therapy.\n* Child-Pugh class A liver function.\n* ECOG performance status 0 or 1.\n* Adequate organ and bone marrow function, based on laboratory tests within 7 days before enrollment: ANC ≥1.5 × 10\\^9/L; platelet count ≥75 × 10\\^9/L; hemoglobin ≥9.0 g/dL; total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤3 × ULN; serum albumin ≥28 g/L; serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min by Cockcroft-Gault; urine protein \\<2+, or, if ≥2+ at baseline, 24-hour urine protein \\<1 g; INR and APTT ≤1.5 × ULN; TSH between the lower and upper limits of normal (if abnormal, FT3 and FT4 must be normal).\n\nExclusion Criteria:\n\n* Any cancer treatment other than conversion therapy.\n* Any of the following within 12 months before study start: myocardial infarction, severe/unstable angina, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism; ongoing arrhythmia of CTCAE Grade 2 or higher; or QTc \\>450 ms in men or \\>470 ms in women.\n* Renal insufficiency requiring peritoneal dialysis or hemodialysis.\n* Severe dysfunction of another major organ.\n* Prior diagnosis of a second primary malignancy.\n* Known or new evidence of brain or leptomeningeal disease.\n* Hemophilia or bleeding tendency, or therapeutic anticoagulation with coumarin derivatives.\n* Prior organ transplantation.","locations":[{"facility":"Sun Yat-sen University Cancer Center","city":"Guangzhou","state":"Guangdong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Chenwei Wang","phone":"020-87343114","email":"wangchw@sysucc.org.cn"}],"primaryOutcomes":["2-year recurrence-free survival (RFS) rate"],"hasResults":false,"conditionSlugs":["liver-cancer"],"drugSlugs":[],"locationSlugs":["guangzhou-china"],"enrichment":{"headline":"Anatomic Versus Nonanatomic Liver Resection After Conversion Therapy for Hepatocellular Carcinoma","inPlainEnglish":"This prospective watch-and-measure (no experimental treatment required) cohort study will compare the survival outcomes of anatomic liver resection (ALR) versus nonanatomic liver resection (NALR) in patients with initially unresectable hepatocellular carcinoma (HCC) who become eligible for resection following immune checkpoint inhibitor (ICI)-based conversion therapy. Emerging evidence suggests that surgical resection may provide a survival benefit for selected patients with initially unresectable HCC after conversion therapy; however, the optimal surgical approach for these patients remains unclear.","whoItsFor":["Ages 18 Years to 75 Years","Clinical diagnosis of initially unresectable HCC","Received conversion therapy based on PD-1/PD-L1 therapy","Two liver surgeons with associate senior or higher professional titles determine that R0 resection is feasible after conversion therapy","Child-Pugh class A liver function","how well you can do daily activities (ECOG score) 0 or 1"],"whoShouldSkip":["Any cancer treatment other than conversion therapy","Renal insufficiency requiring peritoneal dialysis or hemodialysis","Severe dysfunction of another major organ","Prior diagnosis of a second primary malignancy","Known or new evidence of brain or leptomeningeal disease","Hemophilia or bleeding tendency, or therapeutic anticoagulation with coumarin derivatives","Prior organ transplantation"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 874 people at Guangzhou. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:07.620Z"},{"nctId":"NCT07927530","title":"Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain in Patients With Type 2 Diabetes","officialTitle":"Efficacy of Ultrasound-Guided Thoracolumbar Fascia Injection in the Treatment of Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Hatice Zehra FERHATLAR","sponsorClass":"OTHER","summary":"This prospective, randomized, controlled clinical trial aims to evaluate the efficacy of ultrasound-guided thoracolumbar fascia (TLF) injection as an adjunct to standard conservative treatment in patients with type 2 diabetes mellitus and chronic nonspecific low back pain.\n\nA total of 60 patients aged 18-65 years, diagnosed with type 2 diabetes mellitus for at least one year and experiencing chronic nonspecific low back pain for at least three months, will be enrolled. Eligible participants will be randomly assigned to two groups. The intervention group will receive ultrasound-guided thoracolumbar fascia injection in addition to standard conservative treatment, while the control group will receive standard conservative treatment alone, consisting of patient education and a structured exercise program.\n\nClinical assessments will be performed at baseline and at 1 and 3 months after treatment. Treatment outcomes will include pain intensity measured using the Numeric Rating Scale (NRS), functional disability assessed using the Oswestry Disability Index (ODI), pressure pain threshold (PPT) measured by algometry, and analgesic consumption.\n\nThoracolumbar fascia thickness will be measured using ultrasonography at baseline to investigate its potential association with treatment response. Diabetes-related characteristics, including HbA1c levels, diabetes duration, and peripheral neuropathy status, will also be recorded.\n\nThe primary objective is to determine whether adding ultrasound-guided thoracolumbar fascia injection to standard conservative treatment provides greater improvement in pain intensity and functional disability compared with standard conservative treatment alone. The study will also explore whether baseline thoracolumbar fascia thickness and diabetes-related characteristics are associated with clinical outcomes.","conditions":["Chronic Low Back Pain","Type 2 Diabetes Mellitus (DM)"],"keywords":["Thoracolumbar Fascia","Ultrasound-Guided Injection","Chronic Nonspecific Low Back Pain","Type 2 Diabetes Mellitus","Thoracolumbar Fascia Thickness"],"interventions":[{"type":"PROCEDURE","name":"Ultrasound-Guided Thoracolumbar Fascia Injection"},{"type":"BEHAVIORAL","name":"Standard Conservative Treatment"}],"enrollment":60,"startDate":"2026-10-23","completionDate":"2027-04-30","sex":"ALL","minAge":"18 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"\\*\\*Inclusion Criteria:\\*\\*\n\n* Age between 18 and 65 years.\n* Diagnosis of type 2 diabetes mellitus for at least 1 year.\n* Chronic low back pain lasting at least 3 months.\n* Nonspecific or mechanical low back pain.\n* Baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS).\n* Pain or tenderness on palpation over the thoracolumbar fascia region.\n* Willingness to participate in the study.\n* Provision of written informed consent.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Radiculopathy or significant neurological deficits.\n* Neurogenic claudication due to spinal stenosis.\n* Spinal tumor or infection.\n* History or presence of vertebral fracture.\n* Inflammatory rheumatic disease.\n* Spinal surgery within the previous 6 months.\n* Injection in the lumbar region within the previous 3 months.\n* Anticoagulant therapy or conditions contraindicating injection.\n* Active infection at the injection site.\n* Severe systemic disease, including advanced renal failure.\n* Uncontrolled diabetic metabolic condition.\n* Pregnancy.","locations":[{"facility":"Kanuni Sultan Suleyman Training and Research Hospital","city":"Küçükçekmece","state":"Istanbul","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Hatice Zehra FERHATLAR, MD","phone":"05367387869","email":"haticezehraferhatlar@gmail.com"}],"primaryOutcomes":["Change in Low Back Pain Intensity Measured by the Numeric Rating Scale (NRS)"],"hasResults":false,"conditionSlugs":["als","type-2-diabetes"],"drugSlugs":[],"locationSlugs":["k-k-ekmece-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Ultrasound-Guided Thoracolumbar Fascia Injection for Chronic Low Back Pain","inPlainEnglish":"This prospective, randomly assigned, controlled clinical trial aims to measure the how well it works of ultrasound-guided thoracolumbar fascia (TLF) injection as an adjunct to standard conservative treatment in patients with type 2 diabetes mellitus and chronic nonspecific low back pain. A total of 60 patients aged 18-65 years, diagnosed with type 2 diabetes mellitus for at least one year and experiencing chronic nonspecific low back pain for at least three months, will be enrolled.","whoItsFor":["Ages 18 Years to 65 Years","Age between 18 and 65 years","Diagnosis of type 2 diabetes mellitus for at least 1 year","Chronic low back pain lasting at least 3 months","Nonspecific or mechanical low back pain","Baseline pain intensity of ≥4 on the Numeric Rating Scale (NRS)","Pain or tenderness on palpation over the thoracolumbar fascia region","Willingness to participate in the study"],"whoShouldSkip":["Radiculopathy or significant neurological deficits","Neurogenic claudication due to spinal stenosis","Spinal tumor or infection","History or presence of vertebral fracture","Inflammatory rheumatic disease","Spinal surgery within the previous 6 months","Injection in the lumbar region within the previous 3 months"],"whatHappens":"If you join, the listed intervention(s) are Ultrasound-Guided Thoracolumbar Fascia Injection, or Standard Conservative Treatment. The registry lists allocation as randomized. This prospective, randomly assigned, controlled clinical trial aims to measure the how well it works of ultrasound-guided thoracolumbar fascia (TLF) injection as an adjunct to standard conservative treatment in patients with type 2 diabetes mellitus and chronic nonspecific low back pain.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 60 people at Küçükçekmece. Taking part typically means following a program (exercise, therapy, diet, or an app), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.514Z"},{"nctId":"NCT07927569","title":"Integrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion","officialTitle":"RESTORE: A Prospective Observational Study of Perfusion-Metabolism Recoupling and Functional Network Recovery After Recanalization of Non-Acute Atherosclerotic Middle Cerebral Artery Occlusion Using Integrated PET/MR","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Qianfoshan Hospital","sponsorClass":"OTHER","summary":"Restoration of arterial patency following recanalization of non-acute atherosclerotic middle cerebral artery (MCA) occlusion may improve cerebral blood supply. However, the extent to which restored perfusion is accompanied by changes in cerebral metabolism and functional brain network organization remains incompletely understood.\n\nThis prospective observational study, RESTORE, aims to characterize cerebral perfusion-metabolism recoupling and functional network recovery in patients with non-acute atherosclerotic MCA occlusion who undergo clinically indicated recanalization.\n\nIntegrated positron emission tomography/magnetic resonance imaging (PET/MR) will be used to assess cerebral perfusion, metabolic activity, and brain functional connectivity at protocol-defined time points. Imaging measurements will be evaluated in relation to vascular characteristics, recanalization status, and neurological and cognitive outcomes, as applicable.\n\nThe study seeks to clarify the temporal and spatial relationships among reperfusion, metabolic changes, and functional network reorganization, and to explore imaging markers associated with clinical recovery after recanalization.\n\nThe decision to perform recanalization and the selection of treatment strategies will be based on routine clinical care and will not be assigned by the observational study protocol.","conditions":["Middle Cerebral Artery Occlusion","Intracranial Atherosclerosis","Cerebrovascular Disease"],"keywords":[],"interventions":[],"enrollment":15,"startDate":"2024-03-21","completionDate":"2027-01-01","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Aged 18-80 years, regardless of sex.\n2. Symptomatic non-acute middle cerebral artery (MCA) occlusion, with an interval of ≥4 weeks between the most recent ischemic event or imaging confirmation of occlusion and the recanalization procedure.\n3. Occlusion involving the M1 segment of the MCA, confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).\n4. Occlusion presumed to be of atherosclerotic origin.\n5. Persistence of at least one of the following despite guideline-directed medical therapy: recurrent transient ischemic attacks (TIAs), minor ischemic stroke, symptoms attributable to cerebral hypoperfusion, watershed infarction, or imaging evidence of cerebral hypoperfusion or metabolic abnormalities.\n6. Preoperative PET/MR images of sufficient quality for quantitative analysis.\n7. Clinically scheduled to undergo endovascular recanalization.\n8. Provision of written informed consent by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\n1. Acute large-territory cerebral infarction involving more than one-third of the MCA territory.\n2. Extensive encephalomalacia within the affected vascular territory that precludes reliable assessment of cortical regions of interest (ROIs).\n3. Non-atherosclerotic causes of MCA occlusion, including moyamoya disease, arterial dissection, central nervous system vasculitis, or cardioembolism.\n4. Severe bilateral intracranial arterial occlusive disease that precludes reliable calculation of hemispheric asymmetry indices.\n5. Structural lesions involving the cerebellum or brainstem that may interfere with metabolic analysis using the cerebellum as a reference region.\n6. Contraindications to MRI (e.g., incompatible cardiac pacemakers, metallic foreign bodies, or severe claustrophobia) or PET imaging.\n7. Severe head motion or imaging artifacts that render PET/MR, arterial spin labeling (ASL), or blood oxygen level-dependent (BOLD) imaging data unsuitable for analysis.\n8. Poor glycemic control (fasting blood glucose \\>11.1 mmol/L) that may compromise the quality of 18F-fluorodeoxyglucose (18F-FDG) PET imaging.","locations":[{"facility":"The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital","city":"Jinan","state":"Shandong","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ju Han, MD","phone":"86+13791120710","email":"hanjujack@163.com"}],"primaryOutcomes":["Change in Perfusion-Metabolism Abnormality Burden in the Affected Hemisphere From Baseline to 1 Month After Recanalization (ΔPMB)"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["jinan-china"],"enrichment":{"headline":"Integrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion","inPlainEnglish":"Restoration of arterial patency following recanalization of non-acute atherosclerotic middle cerebral artery (MCA) occlusion may improve cerebral blood supply. However, the extent to which restored perfusion is accompanied by changes in cerebral metabolism and functional brain network organization remains incompletely understood.","whoItsFor":["Ages 18 Years to 80 Years","Aged 18-80 years, regardless of sex","Symptomatic non-acute middle cerebral artery (MCA) occlusion, with an interval of ≥4 weeks between the most recent ischemic event or imaging confirmation of occlusion and the recanalization procedure","Occlusion involving the M1 segment of the MCA, confirmed by computed tomography angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA)","Occlusion presumed to be of atherosclerotic origin","Preoperative PET/MR images of sufficient quality for quantitative analysis","Clinically scheduled to undergo endovascular recanalization"],"whoShouldSkip":["Acute large-territory cerebral infarction involving more than one-third of the MCA territory","Extensive encephalomalacia within the affected vascular territory that precludes reliable assessment of cortical regions of interest (ROIs)","Non-atherosclerotic causes of MCA occlusion, including moyamoya disease, arterial dissection, central nervous system vasculitis, or cardioembolism","Severe bilateral intracranial arterial occlusive disease that precludes reliable calculation of hemispheric asymmetry indices","Structural lesions involving the cerebellum or brainstem that may interfere with metabolic analysis using the cerebellum as a reference region","Contraindications to MRI (e.g., incompatible cardiac pacemakers, metallic foreign bodies, or severe claustrophobia) or PET imaging","Severe head motion or imaging artifacts that render PET/MR, arterial spin labeling (ASL), or blood oxygen level-dependent (BOLD) imaging data unsuitable for analysis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 15 people at Jinan. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.207Z"},{"nctId":"NCT07927595","title":"Observational Connectomics in Adults Undergoing Resection of WHO II-IV Glioma","officialTitle":"A Prospective, Longitudinal, Multi-Institutional, Observational Study to Correlate Quantitative Changes of the Human Structural and Functional Connectome in Adults Undergoing Neurosurgical Resection of WHO II-IV Glioma","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Northwell Health","sponsorClass":"OTHER","summary":"This observational study will create a large scale database (registry) of glioma patients' data across multiple participating institutions (hospitals) to study a range of clinical research questions.","conditions":["Glioma","Glioma (Any Grade) in the Brain","Glioblastom WHO Grade 4","Glioblastoma","Glioblastoma (GBM)","Grade III Astrocytoma","Grade II Glioma","Grade IV Astrocytoma","Grade IV Glioma","Grade III Glioma"],"keywords":["Connectome","Observational"],"interventions":[{"type":"OTHER","name":"Connectome MRI"},{"type":"OTHER","name":"Neuropsychological testing"}],"enrollment":125,"startDate":"2026-02-01","completionDate":"2028-02","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. Newly diagnosed patients (by MRI) suspected of having a brain tumor (WHO II,III, or IV) who will undergo surgery with histological confirmation or patients undergoing surgery for recurrent brain tumor (WHO grades II, III, IV) whose histology confirms glioma and/or treatment effect.\n3. Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included.\n4. Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions.\n5. Patient must be able to give informed consent. S/he must be able to read and understand English or there must be a qualified interpreter.\n6. Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses.\n\nExclusion Criteria:\n\n1. Juvenile pilocytic glioma (WHO I)\n2. Histology that is non-glioma, e.g., brain metastases, craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma,\n3. Inability to give informed consent.\n4. Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma\n5. Expected survival \\< 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)\n6. Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,\n7. Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age will need a pregnancy test and agree to contraceptive practices during the course of the study.\n8. Vulnerable population\n9. Medications. There are no restrictions on medications. Patients will receive best standard of care.\n10. Clinical Trials. Patients may also be enrolled in a clinical trial as a clinical trial is always recommended for patients with a glioma per NCCN guidelines.\n11. KPS \\< 40.\n12. Age \\< 17.","locations":[{"facility":"Lenox Hill Brain Tumor Center","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Randy D'Amico, MD","phone":"212-434-3900","email":"rdamico8@northwell.edu"},{"name":"Tamika Wong, MPH","phone":"212-434-4836","email":"twong4@northwell.edu"}],"primaryOutcomes":["Connectomic Metrics","Connectomic Metrics","Connectomic Metrics"],"hasResults":false,"conditionSlugs":["glioblastoma","als"],"drugSlugs":[],"locationSlugs":["new-york-new-york"],"enrichment":{"headline":"Not a traditional drug phase: Connectome MRI for Glioma","inPlainEnglish":"This watch-and-measure (no experimental treatment required) study will create a large scale database (registry) of glioma patients' data across multiple participating institutions (hospitals) to study a range of clinical research questions.","whoItsFor":["Ages 18 Years to any","Diffuse astrocytomas, multifocal gliomas, oligodendrogliomas, midline and brainstem gliomas are included","Previously treated (progressive, recurrent) gliomas are included. Thus, prior surgery, radiation therapy, anti-angiogenic therapy, electrical field therapy are not exclusions","Must be able to undergo sequential MRI in a facility that can perform 30-directional MRI for connectomic analyses"],"whoShouldSkip":["Juvenile pilocytic glioma (WHO I)","Histology that is non-glioma, e.g., brain metastases, craniopharyngioma, ependymoma, medulloblastoma, meningioma, lymphoma, tumefactive (demyelinative) plaque, abscess, germinoma, arachnoid cyst, epidermoid, PXA, DNET, ganglioglioma, central neurocytoma,","Tissue samples obtained at surgery are insufficient/ or non-diagnostic for glioma","Expected survival \\< 90 days due to primary disease or medical co-morbidities. (e.g. sepsis, pneumonia, organ failure)","Inability to have a MRI due to cardiac pacemaker, implants, claustrophobia, allergy to gadolinium,","Pregnancy. Because of potential risk of serial MRI to fetus, women of child-bearing age will need a pregnancy test and agree to contraceptive practices during the course of the study","Vulnerable population"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 125 people at New York. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.470Z"},{"nctId":"NCT07927660","title":"Nurse-Led Interventions Addressing Physical Exercise and Psychological Needs on Enhancing Outcomes in Patients With Chronic Renal Failure","officialTitle":"Effect of Nurse-Led Interventions Addressing Physical Exercise and Psychological Needs on Enhancing Outcomes in Patients With Chronic Renal Failure","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Menoufia University","sponsorClass":"OTHER","summary":"This study aimed to evaluate the effect of a nurse-led intervention addressing physical exercise and psychological needs on enhancing outcomes among patients with chronic renal failure.","conditions":["Nurse-Led Interventions","Physical Exercise","Psychological Needs","Enhance","Chronic Renal Failure"],"keywords":[],"interventions":[{"type":"PROCEDURE","name":"Conventional hospital care"},{"type":"PROCEDURE","name":"Dual-component intervention"}],"enrollment":110,"startDate":"2026-02-01","completionDate":"2027-07-01","sex":"ALL","minAge":"18 Years","maxAge":"60 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Patients aged from 18 to 60 years.\n* Both sexes.\n* Diagnosed with chronic renal failure, patients undergoing regular hemodialysis or admitted to the internal medicine department during the data collection period.\n* Patients who are conscious and able to communicate effectively, and patients willing to participate voluntarily in the study.\n\nExclusion Criteria:\n\n* Patients with severe physical immobility, or medical conditions that completely contraindicate low-to-moderate physical exercise.\n* Patients with cognitive impairment or pre-existing severe psychiatric disorders prior to CRF diagnosis.","locations":[{"facility":"Menoufia University","city":"Shibīn al Kawm","state":"Menoufia","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Aziza S AbdElwahhab, MD","phone":"00201200795054","email":"Aziza.Saeed@nursing.menofia.edu.eg"}],"primaryOutcomes":["Change in Fatigue Level"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["shib-n-al-kawm-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Conventional hospital care for Nurse-Led Interventions","inPlainEnglish":"This study aimed to measure the effect of a nurse-led intervention addressing physical exercise and psychological needs on enhancing outcomes among patients with chronic renal failure.","whoItsFor":["Ages 18 Years to 60 Years","Patients aged from 18 to 60 years","Diagnosed with chronic renal failure, patients undergoing regular hemodialysis or admitted to the internal medicine department during the data collection period"],"whoShouldSkip":["Patients with severe physical immobility, or medical conditions that completely contraindicate low-to-moderate physical exercise","Patients with cognitive impairment or pre-existing severe psychiatric disorders prior to CRF diagnosis"],"whatHappens":"If you join, the listed intervention(s) are Conventional hospital care, or Dual-component intervention. The registry lists allocation as randomized. This study aimed to measure the effect of a nurse-led intervention addressing physical exercise and psychological needs on enhancing outcomes among patients with chronic renal failure.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 110 people at Shibīn al Kawm. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.486Z"},{"nctId":"NCT07927816","title":"CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia","officialTitle":"A Single-Arm, Dose-Escalation Clinical Study on the Safety of CD19 Sequential CD22 In Vivo CAR-T Cell Immunotherapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Liping Dou","sponsorClass":"OTHER","summary":"This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to evaluate the safety, tolerability, preliminary efficacy, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The investigational product is a targeted lentiviral vector that transduces the patient's endogenous T/NK cells in situ; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required. Participants receive an intravenous infusion of CD19-targeted in vivo CAR-T on Day 0, followed by an intravenous infusion of CD22-targeted in vivo CAR-T on Day 7. Before the Day 7 infusion, the investigator will assess each participant to determine whether the second infusion should proceed, based on: (i) the proportion of CAR-positive T/NK cells in peripheral blood, which reflects the success of in vivo transduction and early expansion after the first infusion; (ii) the maximum grade and current control of adverse events occurring after the first infusion, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS); and (iii) the participant's general condition, including Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function (cardiac, hepatic, renal, pulmonary, and coagulation). The second infusion will be postponed or cancelled if any of these assessments indicates that the risk outweighs the benefit, for example grade \\>=3 CRS or grade \\>=2 ICANS that has not resolved to grade \\<=1, or investigator-judged deterioration in organ function. Dose escalation follows a traditional 3+3 design with planned dose levels of 1×10\\^9, 3×10\\^9, and 6×10\\^9 transducing units (TU), guided by dose-limiting toxicities (DLTs) assessed during Days 0-28; higher dose levels may be explored if the maximum tolerated dose is not reached. Treatment-emergent adverse events and serious adverse events, including CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), hematologic toxicity, and organ toxicity, will be assessed. Preliminary antitumor activity will be evaluated by objective response rate (ORR), overall survival (OS), and progression-free survival (PFS), and the expansion and persistence of in vivo-generated CAR-T cells in peripheral blood will also be evaluated.","conditions":["Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia","In Vivo CAR-T","B-Cell Acute Lymphoblastic Leukemia"],"keywords":[],"interventions":[{"type":"DRUG","name":"CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7)"}],"enrollment":12,"startDate":"2026-09-01","completionDate":"2028-08-31","sex":"ALL","minAge":"14 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures.\n* Diagnosis of relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) according to the World Health Organization (WHO) classification, confirmed by bone marrow aspirate morphology, flow cytometry, or histopathology, with tumor cells shown by immunophenotyping or flow cytometry to express CD19 and CD22. Relapsed/refractory B-ALL is defined as meeting at least one of the following four criteria:\n\nRelapse within 6 months after first remission; Primary refractory disease: failure to achieve complete remission after 2 cycles of standard chemotherapy; Failure to achieve complete remission or relapse after one or more lines of salvage chemotherapy; Relapse after hematopoietic stem cell transplantation.\n\n* Male or female participants aged 14 to 75 years, inclusive.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Estimated life expectancy of more than 3 months from the date of signing the informed consent form.\n* Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows:\n\nCreatinine clearance (estimated by the Cockcroft-Gault formula) ≥60 mL/min or serum creatinine ≤1.5 × the upper limit of normal (ULN); Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×upper limit of normal (ULN), total bilirubin≤1.5×ULN; Cardiac ejection fraction≥50%, no pericardial effusion on echocardiography, and no significant abnormalities on electrocardiogram (ECG); No clinically significant pleural effusion, and oxygen saturation \\>92% on room air at baseline.\n\n* Participants of reproductive potential must agree to use highly effective contraception before enrollment and for at least 12 months after SL1CC infusion. A negative serum pregnancy test is required for women of childbearing potential at screening. Participants must immediately notify the investigator if pregnancy occurs or is suspected.\n\nExclusion Criteria:\n\n* The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) \\<50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.\n* A history of severe pulmonary disease associated with impaired lung function.\n* Concurrent progressive malignancy other than acute lymphoblastic leukemia.\n* Severe active infection that cannot be effectively controlled, defined as sepsis or an infection with an uncontrolled infectious focus. Participants may be enrolled after the infection has been adequately controlled.\n* Severe autoimmune disease or congenital immunodeficiency.\n* Active hepatitis B or hepatitis C infection, defined as hepatitis B virus DNA (HBV DNA) or hepatitis C virus RNA (HCV RNA) levels above the lower limit of detection.\n* Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period.\n* History of severe immediate hypersensitivity reactions to any drug required in this study, including antibiotics, or to biological products.\n* Prior treatment with any gene therapy product or any in vivo CAR-T therapy, or known pre-existing neutralizing immunity to the lentiviral vector.\n* Active central nervous system (CNS) leukemia or leptomeningeal involvement not controlled after adequate intrathecal therapy; cerebrospinal fluid examination is required during screening.\n* The patient has severe autoimmune disease, congenital immunodeficiency or active autoimmune disease requiring ongoing systemic immunosuppressive treatment, or is currently within the washout period after having received medications that may affect CAR-T cell immunotherapy, or is anticipated to require medications during the study period that may affect CAR-T cell immunotherapy treatment, or active GVHD requiring systemic therapy.\n* Pregnancy or breastfeeding (lactation).\n* The investigator judges that the patient is unlikely to complete all visits and procedures required by the study protocol (including medium- and long-term follow-up visits), such as insufficient willingness of the patient and their family members to participate in the study, refusal to participate, inability of the patient to fully cooperate with the study arrangements, or inadequate compliance on the part of the patient and their family members.\n* Any other severe physical or psychiatric disorder or clinically significant laboratory abnormality that may increase the risk associated with study participation, interfere with the interpretation of study results, or, in the investigator's judgment, make the participant unsuitable for participation in the study.","locations":[{"facility":"Chinese PLA General Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Li-Ping Dou, Doctor","phone":"+86-13881207138","email":"lipingruirui@163.com"}],"primaryOutcomes":["Safety and Tolerability","Adverse Events","Cytokine Release Syndrome","Immune Effector Cell-associated Neurotoxicity Syndrome"],"hasResults":false,"conditionSlugs":["leukemia","als"],"drugSlugs":["car-t"],"locationSlugs":["beijing-china"],"enrichment":{"headline":"Phase 1: testing CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7) for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia","inPlainEnglish":"This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to measure the safety, tolerability, preliminary how well it works, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL). The investigational product is a targeted lentiviral vector that transduces the patient's endogenous T/NK cells in situ; no leukapheresis, ex vivo manufacturing, or lymphodepleting conditioning is required.","whoItsFor":["Ages 14 Years to 75 Years","Male or female participants aged 14 to 75 years, inclusive","Eastern Cooperative Oncology Group (ECOG) performance status of 0-2","Adequate renal, hepatic, cardiac, and pulmonary function, defined as follows:"],"whoShouldSkip":["A history of severe pulmonary disease associated with impaired lung function","Concurrent progressive malignancy other than acute lymphoblastic leukemia","Severe active infection that cannot be effectively controlled, defined as sepsis or an infection with an uncontrolled infectious focus. Participants may be enrolled after the infection has been adequately controlled","Severe autoimmune disease or congenital immunodeficiency","Active hepatitis B or hepatitis C infection, defined as hepatitis B virus DNA (HBV DNA) or hepatitis C virus RNA (HCV RNA) levels above the lower limit of detection","Human immunodeficiency virus (HIV) infection, known acquired immunodeficiency syndrome (AIDS), or syphilis infection; has received a live vaccine within 4 weeks, or is anticipated to require a live vaccine during the study period","History of severe immediate hypersensitivity reactions to any drug required in this study, including antibiotics, or to biological products"],"whatHappens":"If you join, the listed intervention(s) are CD19-Targeted In Vivo CAR-T Injection (first infusion, Day 0); CD22 -Targeted In Vivo CAR-T Injection (second infusion, Day 7). The registry lists allocation as na. This is a single-center, open-label, single-arm, prospective, investigator-initiated dose-escalation study to measure the safety, tolerability, preliminary how well it works, and cellular kinetics of an in vivo CAR-T cell immunotherapy targeting CD19 sequentially followed by CD22, in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL).","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 12 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.807Z"},{"nctId":"NCT07927933","title":"Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate","officialTitle":"Assessing the Effect of Infant-directed Unidirectional Feeding Valves on Milk Volume Intake in Infants With Cleft Palate- A Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Phoenix Children's Hospital","sponsorClass":"OTHER","summary":"This study aims to assess the impact of using a cleft-adapted bottle with a unidirectional valve compared with a non-cleft-adapted bottle on oral volume intake and milk transfer rate.","conditions":["Cleft Palate","Cleft Palate +/- Lip","Orofacial Cleft"],"keywords":["Unidirectional valve","Feeding","Milk transfer rate"],"interventions":[{"type":"DEVICE","name":"Unidirectional feeding valve"}],"enrollment":74,"startDate":"2026-10-08","completionDate":"2028-12-31","sex":"ALL","minAge":"0 Months","maxAge":"12 Months","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Infants with a diagnosed, unrepaired, overt cleft palate under 12 months gestational age cared for at Phoenix Children's, upon receipt of parental/guardian informed consent to participate.\n* Infant is using the Dr. Brown's® Zero-Resistance Specialty Feeding System® (Narrow nipple or wide-neck options) or the Pigeon Baby Cleft Palate Bottle\n* Infants feeding using milk at IDDSI level 0 (expressed breast milk, commercial formulas, and formula fortified up to 26kcal/ounce)\n\nExclusion Criteria:\n\n* Infants with a submucous cleft palate.\n* Infants receiving supplemental enteral (e.g. \"tube\") feedings.\n* Infants receiving thickened feeds with infant cereal (oatmeal or rice), Gelmix, or pureed food","locations":[{"facility":"Phoenix Children's Hospital","city":"Phoenix","state":"Arizona","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jessica L Chee-Williams, MS","phone":"602-933-1050","email":"jcheewilliams@phoenixchildrens.com"},{"name":"Katelyn J Kotlarek, PhD","phone":"","email":""}],"primaryOutcomes":["Milk volume intake"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["phoenix-arizona"],"enrichment":{"headline":"Not a traditional drug phase: Unidirectional feeding valve for Cleft Palate","inPlainEnglish":"This study aims to assess the impact of using a cleft-adapted bottle with a unidirectional valve compared with a non-cleft-adapted bottle on oral volume intake and milk transfer rate.","whoItsFor":["Ages 0 Months to 12 Months","Infant is using the Dr. Brown's® Zero-Resistance Specialty Feeding System® (Narrow nipple or wide-neck options) or the Pigeon Baby Cleft Palate Bottle","Infants feeding using milk at IDDSI level 0 (expressed breast milk, commercial formulas, and formula fortified up to 26kcal/ounce)"],"whoShouldSkip":["Infants with a submucous cleft palate","Infants receiving supplemental enteral (e.g. \"tube\") feedings","Infants receiving thickened feeds with infant cereal (oatmeal or rice), Gelmix, or pureed food"],"whatHappens":"If you join, the listed intervention(s) are Unidirectional feeding valve. The registry lists allocation as randomized. This study aims to assess the impact of using a cleft-adapted bottle with a unidirectional valve compared with a non-cleft-adapted bottle on oral volume intake and milk transfer rate.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 74 people at Phoenix. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:34.338Z"},{"nctId":"NCT07927998","title":"A Study of Retifanlimab After Chemoradiation in People With Anal Cancer","officialTitle":"A Phase II Trial Evaluating Personalized Anal Squamous Cell Carcinoma Treatment Escalation Using Real-Time ctDNA Surveillance (PACER)","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Memorial Sloan Kettering Cancer Center","sponsorClass":"OTHER","summary":"Participants will receive retifanlimab during 28-day treatment Cycles and will continue to receive retifanlimab for up to 6 Cycles (up to 12 Cycles with study doctor approval) unless the participant's cancer comes back, have serious side effects and cannot continue study treatment, or the study doctor thinks it is in the participant's best interest to stop.","conditions":["Anal Squamous Cell Carcinoma","Anal Cancer","Anal Carcinoma"],"keywords":["Anal Squamous Cell Carcinoma","Anal Cancer","Anal Carcinoma","Memorial Sloan Kettering Cancer Center","26-298"],"interventions":[{"type":"DRUG","name":"Retifanlimab"}],"enrollment":25,"startDate":"2026-11-04","completionDate":"2029-11-04","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Subject or legally authorized representative is willing and able to provide written informed consent.\n* Age ≥ 18 on day of signing informed consent.\n* Consent for use of archival tissue and blood draws for research purposes.\n* Documentation of Disease\n\n  o Patients must have pathologically confirmed anal squamous cell carcinoma.\n\n  ° Pathology confirmation of the primary tumor at time of initial diagnosis is acceptable.\n* Disease Specific Criteria\n\n  * Patients must have MRD after completion of definitive-CRT defined as:\n\n    * Detectable on the last day of or after completing definitive-CRT.\n    * In patients with MRD within 6 months of CRT completion, patients with no overt clinical or radiographic progression will be eligible, the treatment response evolves for up to 6-months after completion of CRT. The ACT II trial demonstrated that 70% of patients with an incomplete response to CRT at 3-months achieved a clinical complete response by 6-months \\[18\\].\n    * ctDNA will be assessed using Natera Signatera, a CLIA- validated tumor informed ctDNA assay, which MSK patients currently undergo baseline, on-treatment, and surveillance monitoring as standard of care.\n    * As patients will not have measurable radiographic disease at time of enrollment, RECIST will not be used for study.\n  * Patients must sign informed consent within 4 weeks of positive ctDNA result. The 4 weeks is considered from the date that the ctDNA resulted, and not the date it is drawn.\n* Patients must have completed definitive CRT per institutional standards or as determined appropriate by the principal investigator.\n* Resolution of all non-hematologic toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, which must have resolved to Grade ≤2), alopecia, and other toxicities considered clinically nonsignificant and/or stable on supportive therapy as determined by the investigator.\n\n  o Lymphopenia is a known side effect of CRT, which can take months to resolve \\[4\\], and is not an exclusion to eligibility.\n* ECOG Performance Status of ≤ 2\n* Required Organ Function\n\n  * Adequate hematologic function defined as follows:\n\n    * Absolute neutrophil count (ANC) ≥= 1,000 cells/mm3\n    * Platelets ≥ 75,000 cells/mm3\n    * Hemoglobin ≥ 9 g/dl\n  * Adequate renal function defined as follows:\n\n    * Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula (Note: For agents for which renal excretion is not a major route of clearance and for which renal toxicity is not an issue, the threshold for creatinine clearance should be ≥30 mL/min.):\n\nCrCl (mL/min) = \\[ (140 - Age) × Weight (kg)\\] / \\[72 × Serum Creatinine (mg/dL)\\], multiplied by 0.85 for females.\n\n* Adequate hepatic function defined as follows:\n\n  * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled)\n  * AST and ALT ≤2.5 x institutional ULN\n* Adequate cardiac function defined as follows:\n\n  * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.\n  * To be eligible for this trial, patients with known congestive heart failure should be class 2B or better (see Appendix II: New York Heart Association (NYHA) Functional Classification).\n\nExclusion Criteria:\n\n* Presence of metastatic or recurrent disease.\n* Active infection requiring parenteral antibiotic(s).\n* Known active TB (Bacillus tuberculosis) infection.\n* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Active immune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\>10mg of prednisone or equivalent).\n* Interstitial lung disease or active noninfectious pneumonitis.\n* Known active CNS metastases and/or carcinomatous meningitis.\n* History of allogeneic bone marrow/stem, cell, or solid organ transplant.\n* Pregnant or nursing or expecting to conceive or father children within the projected duration of the trial.\n\n  o Participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months following the completion of study therapy.\n* Uncontrolled infection with human immunodeficiency virus (HIV). HIV-infected patients on effective anti-retroviral therapy with undetectable viral load and CD4+ count \\>300/μL within 6 months are eligible.\n* Known to be hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Patients who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA prior to study entry are eligible.\n* Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Patients on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry.\n* Receipt of a live vaccine within 28 days of planned start of study drug. Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live-attenuated vaccines and are not allowed.\n* Prior therapy with an anti-PD-1, anti-PD-L1, or anti-CTLA-4 agent.\n* History of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent (s) (or any of its excipients).","locations":[{"facility":"Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)","city":"Basking Ridge","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Monmouth (Limited protocol activities)","city":"Middletown","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Bergen (Limited protocol activities)","city":"Montvale","state":"New Jersey","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)","city":"Commack","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Westchester (All protocol activities)","city":"Harrison","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","city":"New York","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null},{"facility":"Memorial Sloan Kettering Nassau (Limited protocol activities)","city":"Rockville Centre","state":"New York","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Paul Romesser, MD","phone":"646-888-2118","email":"romessep@mskcc.org"},{"name":"Andrea Cercek, MD","phone":"646-888-4189","email":"cerceka@mskcc.org"}],"primaryOutcomes":["Rate of ctDNA clearance at 12 weeks"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["basking-ridge-new-jersey","middletown-new-jersey","montvale-new-jersey","commack-new-york","harrison-new-york","new-york-new-york","rockville-centre-new-york"],"enrichment":{"headline":"Phase 2: testing Retifanlimab for Anal Squamous Cell Carcinoma","inPlainEnglish":"Participants will receive retifanlimab during 28-day treatment Cycles and will continue to receive retifanlimab for up to 6 Cycles (up to 12 Cycles with study doctor approval) unless the participant's cancer comes back, have serious side effects and cannot continue study treatment, or the study doctor thinks it is in the participant's best interest to stop.","whoItsFor":["Ages 18 Years to any","Consent for use of archival tissue and blood draws for research purposes","Documentation of Disease","o Patients must have pathologically confirmed anal squamous cell carcinoma","° Pathology confirmation of the primary tumor at time of initial diagnosis is acceptable","Disease Specific Criteria","Patients must have MRD after completion of definitive-CRT defined as:","Detectable on the last day of or after completing definitive-CRT"],"whoShouldSkip":["Presence of metastatic or recurrent disease","Active infection requiring parenteral antibiotic(s)","Known active TB (Bacillus tuberculosis) infection","Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial","Active immune disease requiring systemic immunosuppression in excess of physiologic maintenance doses of corticosteroids (\\>10mg of prednisone or equivalent)","Interstitial lung disease or active noninfectious pneumonitis","Known active CNS metastases and/or carcinomatous meningitis"],"whatHappens":"If you join, the listed intervention(s) are Retifanlimab. The registry lists allocation as na. Participants will receive retifanlimab during 28-day treatment Cycles and will continue to receive retifanlimab for up to 6 Cycles (up to 12 Cycles with study doctor approval) unless the participant's cancer comes back, have serious side effects and cannot continue study treatment, or the study doctor thinks it is in the participant's best interest to stop.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 25 people at 7 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.058Z"},{"nctId":"NCT07928167","title":"Lenvatinib And Stereotactic radiothErapy With pembRolizumab in Metastatic Kidney Cancer Patients","officialTitle":"A Randomized Phase 2 Trial of Lenvatinib Plus Pembrolizumab With or Without Stereotactic Radiation Therapy in Patients With Clear-cell Metastatic Renal Cell Carcinoma, Low Tumor Burden, and Stable Disease.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Kidney Cancer Research Bureau","sponsorClass":"OTHER","summary":"Metastatic clear-cell renal cell carcinoma (ccRCC) is sensitive to therapy with lenvatinib and pembrolizumab. The CLEAR trial demonstrated positive outcomes even in patients with a low tumor burden. In a subset of patients with metastatic ccRCC, the presence of a low tumor burden suggests that incorporating stereotactic body radiotherapy (SBRT) into systemic therapy could be a strategy to enhance the anti-tumor response, while maintaining an acceptable toxicity profile. This study evaluates the contribution of SBRT in a subgroup of patients who have achieved stable disease while receiving lenvatinib and pembrolizumab.","conditions":["Metastatic Renal Cell Carcinoma ( mRCC)"],"keywords":["lenvatinib plus pembrolizumab","stereotactic radiation therapy","stable disease","metastases","first-line treatment","clear cell renal cell carcinoma"],"interventions":[{"type":"DRUG","name":"Lenvatinib"},{"type":"DRUG","name":"Pembrolizumab"},{"type":"RADIATION","name":"Stereotactic Body Radiation Therapy (SBRT)"}],"enrollment":150,"startDate":"2025-08-25","completionDate":"2027-01-15","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Histologically confirmed clear-cell renal cell carcinoma.\n* Presence of measurable lesions per RECIST 1.1.\n* Sum of diameters of target lesions ≤ 7 cm.\n* ECOG 0-2.\n* No prior systemic therapy for metastatic disease.\n\nExclusion Criteria:\n\n* Uncontrolled comorbidities that preclude the use of TKI/IO or SBRT.\n* Prior SBRT to the lesions planned for irradiation, rendering re-irradiation unsafe.\n* Active autoimmune diseases requiring systemic immunosuppressants.\n* Symptomatic CNS metastases (patients with asymptomatic metastases may be included).","locations":[{"facility":"Republican Dispensary of Tatarstan","city":"Kazan'","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"N.N. Blokhin National Medical Research Center of Oncology","city":"Moscow","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"STOONCO clinic","city":"Moscow","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Orenburg Regional Cancer Center","city":"Orenburg","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"SBHI Leningrad Regional Clinical Hospital","city":"Saint Petersburg","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Cancer Center \"Medical City\"","city":"Tyumen","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"Republican Clinical Oncology Dispensary","city":"Ufa","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null},{"facility":"\"ErSpace\" Radiation Therapy Center","city":"Ulyanovsk","state":"","country":"Russia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ilya Tsimafeyeu","phone":"+74999054690","email":"sten_to@mail.ru"}],"primaryOutcomes":["Number of Participants with Response of unirradiated lesions according to RECIST v1.1"],"hasResults":false,"conditionSlugs":["kidney-cancer"],"drugSlugs":["pembrolizumab"],"locationSlugs":["kazan-russia","moscow-russia","orenburg-russia","saint-petersburg-russia","tyumen-russia","ufa-russia","ulyanovsk-russia"],"enrichment":{"headline":"Phase 2: testing Lenvatinib for Metastatic Renal Cell Carcinoma ( mRCC)","inPlainEnglish":"Metastatic clear-cell renal cell carcinoma (ccRCC) is sensitive to therapy with lenvatinib and pembrolizumab. The CLEAR trial demonstrated positive outcomes even in patients with a low tumor burden.","whoItsFor":["Ages 18 Years to any","Histologically confirmed clear-cell renal cell carcinoma","Presence of measurable lesions per RECIST 1.1","Sum of diameters of target lesions ≤ 7 cm","No prior systemic therapy for metastatic disease"],"whoShouldSkip":["Uncontrolled comorbidities that preclude the use of TKI/IO or SBRT","Prior SBRT to the lesions planned for irradiation, rendering re-irradiation unsafe","Active autoimmune diseases requiring systemic immunosuppressants","Symptomatic CNS metastases (patients with asymptomatic metastases may be included)"],"whatHappens":"If you join, the listed intervention(s) are Lenvatinib, Pembrolizumab, or Stereotactic Body Radiation Therapy (SBRT). The registry lists allocation as randomized. Metastatic clear-cell renal cell carcinoma (ccRCC) is sensitive to therapy with lenvatinib and pembrolizumab.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 150 people at 8 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:06.895Z"},{"nctId":"NCT07928531","title":"Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function","officialTitle":"Impact of Acute Blood Flow Restriction Walking on Immune Cell Phenotype and Function in Adults withT2D","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"University of British Columbia","sponsorClass":"OTHER","summary":"To conduct a randomized control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.","conditions":["Type 2 Diabetes"],"keywords":[],"interventions":[{"type":"OTHER","name":"Exercise with BFR"},{"type":"OTHER","name":"Exercise"}],"enrollment":20,"startDate":"2026-02-11","completionDate":"2027-12-31","sex":"ALL","minAge":"19 Years","maxAge":"64 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Aged 19-64 years\n* Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0%\n* Completing \\<150 minutes of moderate-vigorous physical activity per week.\n\nExclusion Criteria:\n\n* Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.\n* Unstable type 2 diabetes medication of the last 3 months\n* Absolute contraindications to BFR (i.e., peripheral vascular disease)\n* A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions\n* A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)\n* Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely\n* Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity","locations":[{"facility":"University of British Columbia Okanagan","city":"Kelowna","state":"British Columbia","country":"Canada","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Jonathan P Little, PhD","phone":"250-807-9876","email":"jonathan.little@ubc.ca"}],"primaryOutcomes":["Change in white blood cell count before, during, and after exercise."],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["kelowna-canada"],"enrichment":{"headline":"Not a traditional drug phase: Exercise with BFR for Type 2 Diabetes","inPlainEnglish":"To conduct a randomly assigned control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.","whoItsFor":["Ages 19 Years to 64 Years","Diagnosed with type 2 diabetes with current HbA1c 5.7-9.0%","Completing \\<150 minutes of moderate-vigorous physical activity per week"],"whoShouldSkip":["Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise","Unstable type 2 diabetes medication of the last 3 months","Absolute contraindications to BFR (i.e., peripheral vascular disease)","A self-reported diagnosis of low iron concentrations, anemia, or being treated for these conditions","A diagnosis of any red blood cell-altering condition (i.e., sickle cell anemia, poikilocytosis)","Currently living with any cardiovascular disease, which would impact the ability to participate in exercise safely","Currently prescribed any medication which would impact the ability to use a heart rate monitor to accurately track intensity"],"whatHappens":"If you join, the listed intervention(s) are Exercise with BFR, or Exercise. The registry lists allocation as randomized. To conduct a randomly assigned control trial to determine the impact of acute blood flow restriction treadmill walking on immune cell counts, function, and phenotype in adults living with type 2 diabetes.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 20 people at Kelowna. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.513Z"},{"nctId":"NCT07928661","title":"Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 Diabetes","officialTitle":"Open Label Evaluator Blind,The Effect of Proliverenol Supplementation on the Visceral Adiposity Index, HOMA-IR, C-Peptide, and Controlled Attenuation Parameter (CAP) in Patients With Type 2 Diabetes at Dr. Mohammad Hoesin General Hospital in Palembang.","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"Universitas Sriwijaya","sponsorClass":"OTHER","summary":"This study aims to determine whether Proliverenol supplementation can improve liver fat levels and blood sugar control in patients with type 2 diabetes. Participants will be divided into two groups: one group will receive Proliverenol with standar therapy of DM, and the other only receive standar therapy of DM. The study will last for 12 weeks, and participants will undergo blood tests and liver examinations.\"","conditions":["Diabetes Mellitus, Type 2"],"keywords":["Diabetes Mellitus Type 2","Visceral Adiposity Index","HOMA-IR","C-Peptide","Controlled Attenuation Parameter"],"interventions":[{"type":"DRUG","name":"Proliverenol"}],"enrollment":50,"startDate":"2026-07-29","completionDate":"2026-12","sex":"ALL","minAge":"30 Years","maxAge":"65 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* All patients diagnosed with Type 2 diabetes\n* VAI values: women \\> 0.705, men \\> 1.48, or CAP values ≥ 236\n* Ages 30-65 years\n* Receiving standard Type 2 diabetes treatment for at least 3 months with HbA1c levels between 7% and 9.5%.\n* Willing to participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Taking long-term steroid medication, either oral or systemic.\n* Pregnant or breastfeeding women\n* History of or currently suffering from an autoimmune disease\n* History of or previous infection with hepatitis B or C\n* ALT/AST levels \\> 2x ULN, eGFR \\< 60, or unstable heart disease.\n* Regular alcohol consumption","locations":[{"facility":"University of Sriwijaya Palembang","city":"Palembang","state":"South Sumatera","country":"Indonesia","status":"RECRUITING","lat":null,"lon":null}],"contacts":[],"primaryOutcomes":["Change in the Visceral Adiposity Index (VAI) from baseline to week 12","Change in HOMA-IR from baseline to week 12","Change in C-Peptide from baseline to week 12","Change in Controlled Attenuation Parameter (CAP) from baseline to week 12"],"hasResults":false,"conditionSlugs":["type-2-diabetes"],"drugSlugs":[],"locationSlugs":["palembang-indonesia"],"enrichment":{"headline":"Phase 2: testing Proliverenol for Diabetes Mellitus, Type 2","inPlainEnglish":"This study aims to determine whether Proliverenol supplementation can improve liver fat levels and blood sugar control in patients with type 2 diabetes. you would be divided into two groups: one group will receive Proliverenol with standar therapy of DM, and the other only receive standar therapy of DM.","whoItsFor":["Ages 30 Years to 65 Years","All patients diagnosed with Type 2 diabetes","VAI values: women \\> 0.705, men \\> 1.48, or CAP values ≥ 236","Receiving standard Type 2 diabetes treatment for at least 3 months with HbA1c levels between 7% and 9.5%"],"whoShouldSkip":["Taking long-term steroid medication, either oral or systemic","Pregnant or breastfeeding women","History of or currently suffering from an autoimmune disease","History of or previous infection with hepatitis B or C","ALT/AST levels \\> 2x ULN, eGFR \\< 60, or unstable heart disease","Regular alcohol consumption"],"whatHappens":"If you join, the listed intervention(s) are Proliverenol. The registry lists allocation as randomized. This study aims to determine whether Proliverenol supplementation can improve liver fat levels and blood sugar control in patients with type 2 diabetes.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 50 people at Palembang. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.515Z"},{"nctId":"NCT07928986","title":"A Multi Center Evaluation of TearCare on Surgical Measurements Before Cataract Surgery","officialTitle":"A Multi Center, Peri-Cataract Evaluation of TearCare With Expression on Ocular Biometry and Surgical Measurements","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Cleveland Eye Clinic","sponsorClass":"OTHER","summary":"The goal of this study is to evaluate whether TearCare treatment stabilizes corneal measurements sufficiently to determine when cataract biometry can be considered reliable.","conditions":["Dry Eye Syndrome (DES)","Meibomian Gland Dysfunction (Disorder)"],"keywords":["Dry Eye","Cataract","Meibomian Gland Dysfunction"],"interventions":[{"type":"DEVICE","name":"Manual expression of meibomian glands after thermal eyelid therapy"}],"enrollment":36,"startDate":"2026-09-22","completionDate":"2026-12","sex":"ALL","minAge":"50 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n1. Age 50-75 years\n2. Diagnosis of MGD and DED\n3. OSDI score 23-79\n4. TBUT \\> 1 second and ≤ 7 seconds\n5. MGSS \\<12 in both eyes\n6. ≥15 expressible meibomian glands\n7. Candidate for cataract surgery planning (ie. Phakic)\n\nExclusion Criteria:\n\n1. Use of:\n\n   1. Cyclosporine, Xiidra, or serum tears within 30 days prior to Screening;\n   2. Antihistamines (oral or topical) within 7 days prior to Screening;\n   3. Oral tetracyclines or azithromycin within 30 days prior to Screening;\n   4. Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, nonsteroidal anti-inflammatory medications within 30 days prior to Screening\n   5. Isotretinoin (e.g. Accutane) at any time.\n2. Any of the following dry eye treatments:\n\n   1. OAice-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \\[LipiFlow\\], iLuxetc.) within 12 months prior to Screening either as part of routine care or clinical investigation;\n   2. Planned or recent surgical procedures to the eye or eyelid (90 days prior to Screening);\n   3. Meibomian gland expression within 6 months prior to Screening;\n   4. Blephex or debridement within 3 months prior TC-2026-TearCare, V2, 15JUN2026 Page 10 of 26 to Screening;\n   5. Punctal occlusion (including collagen, e.g. Soft Plug, UltraPlug, or crosslinked hyaluronic acid, e.g. Lacrifill) or punctal plugs within 15 days of the Screening visit\n   6. Use of tear neurostimulators (i.e., True Tear, iTear100, Tyrvaya) within 2 weeks of the baseline visit. (Subjects must refrain from using tear neurostimulators for the duration of the study)\n   7. Any history of meibomian gland probing.\n3. History of eyelid, conjunctiva, or corneal surgery (including refractive surgery) within 12 months prior to Screening.\n4. Any history of chalazion surgery, surgery on the tarsal conjunctiva, radial keratotomy (RK), complicated blepharoplasty, lid reconstruction, or significant complications post-refractive surgery.\n5. Contact lens use within 2 weeks of the Procedure visit. Subjects presenting at the Screening visit using contact lenses must agree to discontinue use for a full 2 weeks (14 days) prior to the Procedure Visit.\n6. Active hordeolum, stye, or chalazion at the time of the Screening visit\n7. History of Herpes Simplex or Herpes Zoster of the eye or eyelid.\n8. Any active, clinically significant ocular or peri-ocular infection, inflammation, or irritation based on Investigator's judgement.\n9. Recurrent clinically significant eye inflammation, other than dry eye, within 3 months prior to screening based on Investigator's judgement.\n10. Clinically significant anterior blepharitis. In addition, collarettes or flakes of more than one quarter of the eyelid are excluded.\n11. Clinically significant eyelid abnormalities in either eye (e.g. entropion/ectropion, blepharospasm, aponeurotic ptosis, lagophthalmos, distichiasis, trichiasis).\n12. Clinically significant dermatologic or cutaneous disease of the eyelid or periocular area based on Investigator's judgement.\n13. In the clinical judgement of the Investigator, meibomian glands have significant capping, atrophy, or are unable to be expressed, digitally or with a cotton swab. TC-2026-TearCare, V2, 15JUN2026 Page 11 of 26\n14. Corneal surface abnormalities such as corneal epithelial defects (other than punctate staining), ulcers, corneal epithelial dystrophies, keratoconus, and ectatic disease of the cornea\n15. Any active, clinically significant allergic, vernal, or giant papillary conjunctivitis. 16. Ocular trauma within 3 months prior to Screening.\n\n17\\. Known history of diminished or abnormal facial, periocular, ocular or corneal sensation 18. Systemic diseases, in the Investigator's medical judgement, resulting in dry eye (e.g. autoimmune diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, Graves' disease, sarcoidosis, etc.) 19. Subject is currently using Retin A /Retin A derivatives. 20. Subject has permanent eyeliner/lid tattoos, eyelash extensions or wears false eyelashes.\n\n21\\. Subject is currently using Latisse, Lash Boost or any other type of eyelash growth serum. Prostaglandin analog products such as Latisse should not be used within 30 days of the Screening visit.\n\n22\\. Temporary false eyelashes, lash extensions, or any other type of false eyelash within 15 days of the Screening Visit.\n\n23\\. Allergies to silicone tissue adhesives, acrylates and/or copper. 24. Subject has a pacemaker or implantable cardiac defibrillators (ICD). 25. Co-existing condition, either ocular or non-ocular that, in the judgement of the Investigator could aAect the safety or eAectiveness of treatment or the compliance of the subject to the protocol.\n\n\\-","locations":[{"facility":"The Eye Institute of West Florida","city":"Largo","state":"Florida","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Cleveland Eye Clinic","city":"Brecksville","state":"Ohio","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Erin Kus-Kreidler","phone":"216-503-6535","email":"ekus-kreidler@midwestvision.com"}],"primaryOutcomes":["To determine the mean change and stability in IOL predicted power calculation using: Barrett Universal II, Kane Formula and Hill-RBF"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["largo-florida","brecksville-ohio"],"enrichment":{"headline":"Not a traditional drug phase: Manual expression of meibomian glands after thermal eyelid therapy for Dry Eye Syndrome (DES)","inPlainEnglish":"The goal of this study is to evaluate whether TearCare treatment stabilizes corneal measurements sufficiently to determine when cataract biometry can be considered reliable.","whoItsFor":["Ages 50 Years to 75 Years","Diagnosis of MGD and DED","TBUT \\> 1 second and ≤ 7 seconds","MGSS \\<12 in both eyes","≥15 expressible meibomian glands","Candidate for cataract surgery planning (ie. Phakic)"],"whoShouldSkip":["Cyclosporine, Xiidra, or serum tears within 30 days prior to Screening;","Antihistamines (oral or topical) within 7 days prior to Screening;","Oral tetracyclines or azithromycin within 30 days prior to Screening;","Topical ophthalmic antibiotics, anti-glaucoma medications, steroids, nonsteroidal anti-inflammatory medications within 30 days prior to Screening","Isotretinoin (e.g. Accutane) at any time","Any of the following dry eye treatments:","OAice-based dry eye treatment (e.g. IPL, TearCare, thermal pulsation \\[LipiFlow\\], iLuxetc.) within 12 months prior to Screening either as part of routine care or clinical investigation;"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 36 people at 2 sites. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:33.579Z"},{"nctId":"NCT07929090","title":"Pectoral Nerve Block Versus Serratus Posterior Superior Intercostal Plane Block for Pain Control After Mastectomy","officialTitle":"Comparison of the Effects of Pectoral Nerve Block and Serratus Posterior Superior Intercostal Plane Block on Acute and Persistent Postoperative Pain After Mastectomy: A Prospective, Double-Blind, Randomized Controlled Trial","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Bursa City Hospital","sponsorClass":"OTHER_GOV","summary":"This study compares two ultrasound-guided nerve block techniques for pain control after mastectomy for breast cancer: the pectoral nerve block (PECS II) and the serratus posterior superior intercostal plane (SPSIP) block. Both techniques involve injecting local anesthetic near nerves supplying the surgical area.\n\nThe study will include 78 adults aged 18 to 85 years undergoing elective mastectomy under general anesthesia. Participants will be randomly assigned to receive one of the two blocks before surgery. Both groups will receive postoperative pain treatment, including a patient-controlled device that delivers tramadol when needed.\n\nThe main aim is to compare postoperative opioid consumption. The study will also assess pain at rest and during movement, the need for additional pain medication, side effects, recovery quality, and persistent pain. Pain scores and tramadol consumption will be recorded at 0, 2, 4, 8, 16, and 24 hours after surgery. Recovery quality will be assessed at 24 hours, and persistent pain will be assessed by telephone at 3 months.","conditions":["Postoperative Pain","Breast Cancer","Persistent Postsurgical Pain"],"keywords":["Mastectomy","Pectoral Nerve Block","PECS II Block","SPSIP Block"],"interventions":[{"type":"OTHER","name":"Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block"},{"type":"OTHER","name":"Ultrasound-Guided Pectoral Nerve Block Type II"}],"enrollment":78,"startDate":"2026-11-01","completionDate":"2027-06-15","sex":"FEMALE","minAge":"18 Years","maxAge":"85 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age between 18 and 85 years.\n* Scheduled for elective mastectomy for breast cancer under general anesthesia.\n* American Society of Anesthesiologists (ASA) physical status I, II, or III.\n* Willingness to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Refusal to participate in the study.\n* History of bleeding diathesis or coagulopathy.\n* Receiving anticoagulant therapy.\n* Allergy or hypersensitivity to local anesthetics or opioid medications.\n* History of local anesthetic toxicity.\n* Infection at the planned block injection site.\n* Hepatic or renal failure.\n* Uncontrolled diabetes mellitus.\n* Uncontrolled hypertension.\n* Intellectual disability.\n* Receiving opioid treatment for chronic pain.\n* Pregnancy, suspected pregnancy, or breastfeeding.\n* Planned bilateral mastectomy.","locations":[{"facility":"Bursa City Hospital","city":"Nilufer","state":"Bursa","country":"Turkey (Türkiye)","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Enes Batuhan Cansız, MD","phone":"05384600660","email":"enbatuca55@gmail.com"}],"primaryOutcomes":["Postoperative Opioid Consumption"],"hasResults":false,"conditionSlugs":["breast-cancer","als"],"drugSlugs":[],"locationSlugs":["nilufer-turkey-t-rkiye"],"enrichment":{"headline":"Not a traditional drug phase: Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Postoperative Pain","inPlainEnglish":"This study compares two ultrasound-guided nerve block techniques for pain control after mastectomy for breast cancer: the pectoral nerve block (PECS II) and the serratus posterior superior intercostal plane (SPSIP) block. Both techniques involve injecting local anesthetic near nerves supplying the surgical area.","whoItsFor":["Ages 18 Years to 85 Years","Women only","Age between 18 and 85 years","Scheduled for elective mastectomy for breast cancer under general anesthesia","American Society of Anesthesiologists (ASA) physical status I, II, or III"],"whoShouldSkip":["Refusal to participate in the study","History of bleeding diathesis or coagulopathy","Receiving anticoagulant therapy","Allergy or hypersensitivity to local anesthetics or opioid medications","History of local anesthetic toxicity","Infection at the planned block injection site","Hepatic or renal failure"],"whatHappens":"If you join, the listed intervention(s) are Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block, or Ultrasound-Guided Pectoral Nerve Block Type II. The registry lists allocation as randomized. This study compares two ultrasound-guided nerve block techniques for pain control after mastectomy for breast cancer: the pectoral nerve block (PECS II) and the serratus posterior superior intercostal plane (SPSIP) block.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 78 people at Nilufer. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.961Z"},{"nctId":"NCT07929116","title":"Gryrotonic Training in Behcet-diseased Elders With Breast Cancer","officialTitle":"Gryrotonic Training in Behcet-diseased Elders With Breast Cancer","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Cairo University","sponsorClass":"OTHER","summary":"gryrotonic training may be a good exercise modality in Behcet-diseased elders with breast cancer","conditions":["Breast Cancer","Behcet Disease"],"keywords":[],"interventions":[{"type":"BEHAVIORAL","name":"exercise"}],"enrollment":40,"startDate":"2026-11-30","completionDate":"2027-05-30","sex":"FEMALE","minAge":"65 Years","maxAge":"75 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* beast cancer survivors\n* behcet diseas patients\n\nExclusion Criteria:\n\n* cardiac or repiratory or renal failure patients","locations":[{"facility":"Cairo University","city":"Giza","state":"Dokki","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ali MA Ismail, PhD","phone":"+201005154209","email":"ali.mohamed@pt.cu.edu.eg"},{"name":"fatma mohamed, PhD","phone":"01031321109","email":"fatma1995@gmail.com"}],"primaryOutcomes":["Short Physical Performance Battery"],"hasResults":false,"conditionSlugs":["breast-cancer"],"drugSlugs":[],"locationSlugs":["giza-egypt"],"enrichment":{"headline":"Not a traditional drug phase: exercise for Breast Cancer","inPlainEnglish":"Gryrotonic training may be a good exercise modality in Behcet-diseased elders with breast cancer","whoItsFor":["Ages 65 Years to 75 Years","Women only","beast cancer survivors","behcet diseas patients"],"whoShouldSkip":["cardiac or repiratory or renal failure patients"],"whatHappens":"If you join, the listed intervention(s) are exercise. The registry lists allocation as randomized. Gryrotonic training may be a good exercise modality in Behcet-diseased elders with breast cancer","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 40 people at Giza. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:02.963Z"},{"nctId":"NCT07929415","title":"Single Versus Double Stapling and Two Purse-String Techniques in Rectal Cancer Surgery","officialTitle":"Single Vs Double Stapling Technique & Intracorporeal Vs Transanal Purse-String in Low Anterior Resection for Rectal Cancer: An Adjusted Comparative RCT Evaluating Anastomotic Leak, Oncological and Patient-Reported Outcomes","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"RANDOMIZED","interventionModel":"PARALLEL","masking":"SINGLE","sponsor":"Alexandria University","sponsorClass":"OTHER","summary":"This study compares ways of joining the bowel after surgery for rectal cancer. It aims to find out whether using a single-stapling technique leads to fewer bowel leaks than using a double-stapling technique. It also compares two ways of placing the closing stitch used in the single-stapling technique.\n\nThe study will include 124 adults having planned surgery to remove rectal cancer while preserving the anus. After removing the affected part of the rectum, the surgeon joins the remaining bowel. A leak can occur if this join does not heal properly.\n\nParticipants will be assigned by chance during surgery to one of two techniques:\n\nDouble stapling: the surgeon closes the remaining rectum with a straight stapler, then uses a circular stapler to join the bowel.\n\nSingle stapling: the surgeon closes the remaining rectum with a drawstring-like stitch, then uses a circular stapler to join the bowel.\n\nParticipants assigned to single stapling will have a second assignment by chance. The surgeon will place the closing stitch either from inside the abdomen or through the anus.\n\nThe main outcome is a bowel leak that requires treatment within 30 days after surgery. Researchers will also compare other complications, recovery, findings from the removed cancer tissue, and whether the cancer returns locally during the first year.\n\nParticipants will be followed for 12 months after surgery. They will complete questionnaires about bowel function, bowel control, and quality of life at 6 and 12 months.","conditions":["Rectal Cancer"],"keywords":["Rectal Adenocarcinoma","Low Anterior Resection","Total Mesorectal Excision","Single-Stapling Technique","Double-Stapling Technique","Intracorporeal Purse-String"],"interventions":[{"type":"PROCEDURE","name":"Double-Stapled Anastomosis"},{"type":"PROCEDURE","name":"Single-Stapled Anastomosis With Intracorporeal Purse-String"},{"type":"PROCEDURE","name":"Single-Stapled Anastomosis With Transanal Purse-String"}],"enrollment":124,"startDate":"2026-11-05","completionDate":"2027-05-01","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-80 years.\n* Histologically confirmed rectal adenocarcinoma, with the tumor located within 16 cm of the anal verge, measured by rigid proctoscopy or magnetic resonance imaging.\n* Candidate for elective sphincter-preserving low anterior resection with total mesorectal excision.\n* American Society of Anesthesiologists (ASA) physical status classification I-III.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Locally advanced disease unsuitable for curative resection or metastatic disease (M1).\n* Emergency surgery for obstruction or perforation.\n* Previous pelvic radiotherapy for conditions other than the current rectal cancer.\n* Planned abdominoperineal resection or Hartmann's procedure.\n* Coagulopathy or contraindication to the use of surgical stapling devices.\n* Inability to complete follow-up questionnaires.","locations":[{"facility":"Alexandria University","city":"Alexandria","state":"","country":"Egypt","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Ahmed Mohi eldein, PhD","phone":"+201281362223","email":"Ahmed.eldaoushy@alexmed.edu.eg"}],"primaryOutcomes":["Clinically Significant Anastomotic Leak Within 30 Days"],"hasResults":false,"conditionSlugs":["als"],"drugSlugs":[],"locationSlugs":["alexandria-egypt"],"enrichment":{"headline":"Not a traditional drug phase: Double-Stapled Anastomosis for Rectal Cancer","inPlainEnglish":"This study compares ways of joining the bowel after surgery for rectal cancer. It aims to find out whether using a single-stapling technique leads to fewer bowel leaks than using a double-stapling technique.","whoItsFor":["Ages 18 Years to 70 Years","Histologically confirmed rectal adenocarcinoma, with the tumor located within 16 cm of the anal verge, measured by rigid proctoscopy or magnetic resonance imaging","Candidate for elective sphincter-preserving low anterior resection with total mesorectal excision","American Society of Anesthesiologists (ASA) physical status classification I-III"],"whoShouldSkip":["Locally advanced disease unsuitable for curative resection or metastatic disease (M1)","Emergency surgery for obstruction or perforation","Previous pelvic radiotherapy for conditions other than the current rectal cancer","Planned abdominoperineal resection or Hartmann's procedure","Coagulopathy or contraindication to the use of surgical stapling devices","Inability to complete follow-up questionnaires"],"whatHappens":"If you join, the listed intervention(s) are Double-Stapled Anastomosis, Single-Stapled Anastomosis With Intracorporeal Purse-String, or Single-Stapled Anastomosis With Transanal Purse-String. The registry lists allocation as randomized. This study compares ways of joining the bowel after surgery for rectal cancer.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 124 people at Alexandria. Taking part typically means a procedure as part of the study plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.055Z"},{"nctId":"NCT07929636","title":"Tracking Outcomes in Patients With Chronic Pain Prescribed Intravenous Lidocaine","officialTitle":"Tracking Outcomes by Secondary Diagnoses in Patients Prescribed Intravenous Lidocaine for Chronic Pain","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"International Spine, Pain and Performance Center","sponsorClass":"OTHER","summary":"The purpose of this research is to gather data on the performance and functionality of IV lidocaine infusions prescribed to patients with chronic pain.","conditions":["Chronic Pain Syndrome"],"keywords":["Chronic Pain Syndrome","Lidocaine","IV Infusion"],"interventions":[{"type":"DRUG","name":"Lidocaine IV"}],"enrollment":100,"startDate":"2023-11-06","completionDate":"2027-12-31","sex":"ALL","minAge":"18 Years","maxAge":"80 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Age 18-80 years\n* Patients with chronic pain syndrome\n* Patients that have been prescribed and scheduled to receive an intravenous lidocaine infusion treatment\n\nExclusion Criteria:\n\n* Not willing to comply with the requirements of the study","locations":[{"facility":"International Spine Pain & Performance Center","city":"Washington D.C.","state":"District of Columbia","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Victoria Brownlee, MPH","phone":"202-849-8333","email":"vbrownlee@isppcenter.com"},{"name":"John Behun","phone":"202-849-8334","email":"jbehun@isppcenter.com"}],"primaryOutcomes":["Change from Baseline in Pain Intensity on the Visual Analog Scale (VAS) at 3 Months"],"hasResults":false,"conditionSlugs":[],"drugSlugs":[],"locationSlugs":["washington-d-c-district-of-columbia"],"enrichment":{"headline":"Not a traditional drug phase: testing Lidocaine IV for Chronic Pain Syndrome","inPlainEnglish":"The purpose of this research is to gather data on the performance and functionality of IV lidocaine infusions prescribed to patients with chronic pain.","whoItsFor":["Ages 18 Years to 80 Years","Patients with chronic pain syndrome","Patients that have been prescribed and scheduled to receive an intravenous lidocaine infusion treatment"],"whoShouldSkip":["People the protocol lists as excluded — the study team must confirm."],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 100 people at Washington D.C.. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:31.922Z"},{"nctId":"NCT07929792","title":"An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke","officialTitle":"An Early Feasibility Study of a Robotically Implanted Brain-Computer Interface for Neural Control of External Devices in Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Chronic Ischemic Stroke","status":"RECRUITING","phases":["NA"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Neuralink Corp","sponsorClass":"INDUSTRY","summary":"The purpose of this study is to evaluate the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot. The study builds on knowledge gained in a previous clinical investigation of this system. It enrolls adults with severe upper-limb impairment from spinal cord injury, amyotrophic lateral sclerosis (ALS), or chronic ischemic stroke. Participants use neural signals recorded by the N1 Implant to control a computer cursor or virtual keyboard. The study will describe serious adverse device effects and will assess digital daily activities, computer-control performance, independent use of the system, and participant-, clinician-, and caregiver-reported outcomes. Up to 10 participants will be enrolled at up to five sites in the United States and followed for about 2 years after implantation, or about 3 years if they choose extended follow-up. There is no comparison group; each participant's results are compared with their own baseline.","conditions":["Spinal Cord Injury","Amyotrophic Lateral Sclerosis","Chronic Ischemic Stroke","Tetraplegia/Tetraparesis"],"keywords":["spinal cord injury","SCI","BCI","brain computer interface","ALS","quadriplegia","tetraplegic","paralysis","stroke","chronic ischemic stroke"],"interventions":[{"type":"DEVICE","name":"N1 Implant"},{"type":"DEVICE","name":"R1 Robot"}],"enrollment":10,"startDate":"2026-11","completionDate":"2027-11","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n● A diagnosis of: (A) Spinal cord injury (SCI) for at least 12 months with a muscle power grade of ≤ 3/5 in all muscles of the arms and hands principally innervated by C6-T1 nerve roots at the time of screening AND the Investigator confirms that bilateral upper-limb weakness prevents reliable, independent use of standard digital-access devices. OR (B) Amyotrophic lateral sclerosis (ALS) with\n\n1. Muscle power grade ≤4/5 at C5 in both arms; AND\n2. Muscle power grade ≤3/5 in all muscles of both arms and hands principally innervated by C6-T1 nerve roots, except that strength above 3/5 in individual C6-T1 muscle groups is permitted if both of the following are met:\n\n   1. ALSFRS-R Item 4 (Handwriting) score ≤2; AND\n   2. The Investigator confirms that bilateral upper-limb weakness prevents reliable, independent use of standard digital-access devices. OR (C) Chronic ischemic stroke, with the event occurring at least 12 months before screening, resulting in residual hemiparesis of the pre-morbid dominant upper extremity, with a completion time on the Nine-Hole Peg Test (9-HPT), per standardized protocol, that exceeds 3 standard deviations above the respective established age- and hand-specific normative mean completion times for both hands.\n\n      * Age ≥ 18 years.\n      * Stable medical, physical, and psychological condition as considered by the investigators.\n      * Ability to communicate verbally or with the use of a computer or communication aid.\n      * Willingness to comply with all study procedures and availability for the duration of the study.\n      * If the participant requires daily continuous support from a personal caregiver, the presence of a caregiver throughout the study is mandatory.\n      * Willingness and ability of a caregiver to monitor the participant for medical complications and behavioral changes, and respond to alerts regarding device function.\n      * Presence of or willingness to acquire reliable internet.\\*\n      * Willing and able to provide informed consent. \\*Sponsor will reimburse participants for the cost of reasonable high-speed internet as needed during participation in the study\n\n      Exclusion Criteria:\n      * ● History of poorly controlled seizures or epilepsy.\n\n        * History of poorly controlled autonomic dysreflexia.\n        * Morbid obesity (Body Mass Index \\> 40).\n        * Current deep venous thrombosis or pulmonary embolism.\n        * Diagnosis of acute myocardial infarction or cardiac arrest within the last 12 months.\n        * Requires magnetic resonance imaging (MRI) for any ongoing medical conditions within the next year\n        * Any implanted, or previously explanted, intracranial device, except where:\n\n          1. the device is a marketed intracranial stent or other endovascular implant that is labeled MR Conditional, and the Neurosurgeon confirms during preoperative surgical planning that its location is compatible with the planned craniectomy and thread insertion trajectory; or\n          2. the explanted device was not previously implanted in the same hemisphere as the hemisphere of interest for the implantation of the N1 Implant\n        * Any active implanted devices including but not limited to cardiac pacemakers, cardiac defibrillators, diaphragmatic pacemakers, peripheral or central nerve stimulators\\*.\n        * Currently receiving or may receive transcranial magnetic stimulation therapy, diathermy, electroconvulsive therapy, or transcranial ultrasound within the next year.\n        * Pregnant or of child-bearing potential and not using or planning to use contraception during the period of study participation.\n        * Presence of mild or greater cognitive impairment per neuropsychological assessments.\n        * Psychotic illness or chronic psychiatric disorder, or major depression if untreated (Diagnosis of Axis I or Axis II).\n        * Contraindication for preoperative MRI.\n        * Preoperative brain MRI demonstrating hemorrhage, tumor, distorted or adverse anatomy.\n        * History of gadolinium contrast allergy.\n        * Any type of destruction and/or damage to the primary motor cortex region as determined by MRI.\n        * Are blind.\n        * Ongoing use of anticoagulant or antiplatelet medication that cannot be suspended perioperatively.\n        * Receiving invasive mechanical ventilation without a tracheostomy that has been in place for at least 3 months, or without stable ventilator settings for at least 1 month prior to enrollment.\n        * May require invasive mechanical ventilation within the next year, and does not intend to undergo tracheostomy or placement of a percutaneous endoscopic gastrostomy (PEG) tube if invasive ventilation becomes necessary.\n        * Currently participating in an investigational study (device and/or pharmaceutical) within 30 days prior to entering this study, or such investigational treatment planned during the 24 months following enrollment, unless approved by Sponsor.\n        * Anatomical or functional characteristics of the skull, meninges, and brain incompatible with the surgical approach and N1 Implant, as assessed by\n\n      MRI or CT, specifically:\n      * Outer skull-to-pia distance \\< 5.4 mm over region of interest.\n      * Scalp thickness \\< 3 or \\> 20 mm over region of interest.\n      * Imaging evidence of stroke in the planned implant cortical target (for stroke patient population).\n      * Any condition, including serious co-morbidities such as major organ failure, which in the opinion of the Investigator, would compromise the participant's ability to safely participate in the study or undergo the implantation procedure. \\*Intrathecal baclofen pumps are exempt from this criterion.","locations":[{"facility":"University of Miami","city":"Miami","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Neuralink Clinical Team","phone":"(877) 398-4465","email":"clinical-team-ct@neuralink.com"}],"primaryOutcomes":["Serious adverse device effects (SADEs)"],"hasResults":false,"conditionSlugs":["als","stroke"],"drugSlugs":[],"locationSlugs":["miami-florida"],"enrichment":{"headline":"Not a traditional drug phase: N1 Implant for Spinal Cord Injury","inPlainEnglish":"This study wants to measure the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot. The study builds on knowledge gained in a previous clinical investigation of this system.","whoItsFor":["Ages 18 Years to any","Muscle power grade ≤4/5 at C5 in both arms; AND","Muscle power grade ≤3/5 in all muscles of both arms and hands principally innervated by C6-T1 nerve roots, except that strength above 3/5 in individual C6-T1 muscle groups is permitted if both of the following are met:","ALSFRS-R Item 4 (Handwriting) score ≤2; AND","Stable medical, physical, and psychological condition as considered by the investigators","Ability to communicate verbally or with the use of a computer or communication aid","Willingness to comply with all study procedures and availability for the duration of the study","If the participant requires daily continuous support from a personal caregiver, the presence of a caregiver throughout the study is mandatory"],"whoShouldSkip":["● History of poorly controlled seizures or epilepsy","History of poorly controlled autonomic dysreflexia","Morbid obesity (Body Mass Index \\> 40)","Current deep venous thrombosis or pulmonary embolism","Diagnosis of acute myocardial infarction or cardiac arrest within the last 12 months","Requires magnetic resonance imaging (MRI) for any ongoing medical conditions within the next year","Any implanted, or previously explanted, intracranial device, except where:"],"whatHappens":"If you join, the listed intervention(s) are N1 Implant, or R1 Robot. The registry lists allocation as na. This study wants to measure the safety and preliminary effectiveness of the N1 System, a fully implanted brain-computer interface placed in the motor cortex with the R1 Robot.","phaseExplainer":"This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.","effort":"They plan to enroll about 10 people at Miami. Taking part typically means using or being fitted with a device plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:10.598Z"},{"nctId":"NCT07929831","title":"The Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity","officialTitle":"Uncovering the Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity: an Observational Prospective Cohort","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"Radboud University Medical Center","sponsorClass":"OTHER","summary":"The goal of this observational study is to learn how treatment with incretins, such as semaglutide and tirzepatide, affects muscle mass, muscle strength, and physical function in people with overweight or obesity.\n\nThe main questions this study aims to answer are:\n\n* What is the composition of weight loss during incretin treatment?\n* What is the composition of recurrent weight gain after stopping incretin treatment?\n\nAn additional question this study aims to answer is:\n\n\\- How do muscle strength and physical function change during and after incretin treatment?\n\nTwo groups of patients will be included: patients who start with incretin therapy for overweight/obesity and patients who stop incretin therapy for overweight/obesity.\n\nParticipants who start incretin treatment will have measurements before starting treatment, after six months, and after twelve months or when treatment is stopped. Participants who stop incretin treatment will have measurements before stopping treatment, after six months, and after twelve months or before restarting treatment.\n\nMeasurements include:\n\n* Height, length, waist circumference\n* Body composition measured with InBody, with a Dual-Energy X-ray Absorptiometry in a subgroup of the participants\n* Muscle strength tests\n* Physical function tests\n* Blood samples to asses metabolic health\n* Physical activity measured with an activity monitor (ActivPAL)\n* Questionnaires about health, incretin treatment, physical activity, and diet\n\nNo treatment or medication will be given as part of the study. Participants will receive incretin treatment as part of their usual care.","conditions":["Obesity & Overweight"],"keywords":["Obesity","Overweight","Muscle mass","Fat-free mass","Functional capacity","Muscle strength"],"interventions":[],"enrollment":200,"startDate":"2026-08-28","completionDate":"2027-02-01","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Screened and planned to start with incretin treatment or currently using incretin and planned to discontinue treatment.\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Inability to comprehend scheduled procedures (e.g., language barriers)\n* Unable to perform the physical tests due to physical disabilities\n* Patients who underwent MBS or including endoscopic interventions and gastric balloon placement.\n* Prior use of incretins, or other obesity medication.","locations":[{"facility":"NOK clinics","city":"Amsterdam","state":"","country":"Netherlands","status":"RECRUITING","lat":null,"lon":null},{"facility":"NOK Clinics","city":"Nieuwegein","state":"","country":"Netherlands","status":"NOT_YET_RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Puck van den Hooff","phone":"0031 30 698 60 90","email":"puck.vandenhooff@radboudumc.nl"},{"name":"Jan Karregat","phone":"","email":"jan.karregat@radboudumc.nl"}],"primaryOutcomes":["The composition of weight loss during treatment","The composition of recurrent weight gain after cessation of treatment"],"hasResults":false,"conditionSlugs":["obesity"],"drugSlugs":["semaglutide","tirzepatide"],"locationSlugs":["amsterdam-netherlands","nieuwegein-netherlands"],"enrichment":{"headline":"The Impact of Incretins on Fat-free Mass, Muscle Strength and Functional Capacity","inPlainEnglish":"The goal of this watch-and-measure (no experimental treatment required) study is to learn how treatment with incretins, such as semaglutide and tirzepatide, affects muscle mass, muscle strength, and physical function in people with overweight or obesity. The main questions this study aims to answer are: * What is the composition of weight loss during incretin treatment?","whoItsFor":["Ages 18 Years to any","Screened and planned to start with incretin treatment or currently using incretin and planned to discontinue treatment","Aged 18 years or older"],"whoShouldSkip":["Inability to comprehend scheduled procedures (e.g., language barriers)","Unable to perform the physical tests due to physical disabilities","Patients who underwent MBS or including endoscopic interventions and gastric balloon placement","Prior use of incretins, or other obesity medication"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 200 people at 2 sites. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:11.824Z"},{"nctId":"NCT07929909","title":"A Phase I Clinical Study of YN003 in the Treatment of Glioma","officialTitle":"A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma","status":"RECRUITING","phases":["PHASE1"],"studyType":"INTERVENTIONAL","allocation":"NA","interventionModel":"SINGLE_GROUP","masking":"NONE","sponsor":"Beijing Inno Medicine Co., Ltd.","sponsorClass":"INDUSTRY","summary":"This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of YN003 Injection in patients with recurrent or progressive glioma. The study consists of Part A (dose escalation using a Bayesian Optimal Interval design) and Part B (dose expansion at the recommended Phase 2 dose).","conditions":["Glioma","Glioblastoma","Brain Neoplasms"],"keywords":["YN003","BOIN","glioma","recurrent","progressive","liposomal injection"],"interventions":[{"type":"DRUG","name":"YN003 Injection"}],"enrollment":50,"startDate":"2026-10-27","completionDate":"2028-12-31","sex":"ALL","minAge":"18 Years","maxAge":"70 Years","healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Voluntarily sign the informed consent form, understand the study, and be willing to comply with the protocol and complete all study procedures.\n* Male or female subjects 18 years ≤ aged ≤ 70 years.\n* Histologically confirmed recurrent or progressive glioma, including glioblastoma, as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, Grade 3 to Grade 4, following standard therapy.Excluding re-irradiation for same lesions\n* Karnofsky Performance Status (KPS) ≥60.\n* At least one measurable lesion per RANO 2.0 criteria.\n* Have adequate hematologic, cardiac, hepatic, renal, coagulation, and pulmonary function at final screening.\n* Have completed the required washout period for prior therapies before dosing on Day 1.\n* Corticosteroid dose must be stable or tapering within 7 days prior to dosing.\n\nExclusion Criteria:\n\n* Participation in another interventional clinical study within 1 month prior to the date when subject signed the consent form.\n* Receipt of a live vaccine within 30 days prior to study treatment.\n* Pregnant or breastfeeding women.\n* Clinically significant intracranial hypertension (e.g., impending brain herniation or requiring urgent palliative intervention) or uncontrolled seizures. Subjects requiring antiepileptic drugs are eligible only if the dose has been stable for ≥ 14 days prior to first dosing\n* Toxicities from prior anticancer therapy that have not recovered to CTCAE v6.0 Grade ≤1, except for alopecia or other events considered tolerable by the investigator.\n* Contraindications to MRI, including but not limited to pacemakers, epicardial pacing leads, infusion pumps, aneurysm clips, metal fragments, metallic prostheses, magnetic implants, intraocular metal objects, or non-removable metallic dental implants.\n* Uncontrolled or severe cardiovascular or cerebrovascular disease","locations":[{"facility":"University of California, Los Angeles (UCLA)","city":"Los Angeles","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"University of California, San Francisco (UCSF)","city":"San Francisco","state":"California","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"The University of Texas MD Anderson Cancer Center","city":"Houston","state":"Texas","country":"United States","status":"NOT_YET_RECRUITING","lat":null,"lon":null},{"facility":"Beijing Tsinghua Changgung Hospital","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null},{"facility":"Sanbo Brain Hospital, Capital Medical University","city":"Beijing","state":"Beijing Municipality","country":"China","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Kaiqi Zong, Master","phone":"13683178623","email":"zongkaiqi@innovmedicine.com"},{"name":"Yaqian Cui, Master","phone":"18811320289","email":"cuiyaqian@innovmedicine.com"}],"primaryOutcomes":["To Incidence and characteristics of AEs/SAEs；","Incidence of clinically significant abnormalities in laboratory tests","Incidence of clinically significant abnormalities in vital signs","Incidence of clinically significant abnormalities in physical examinations","Change from baseline in 12-lead Electrocardiogram (ECG) parameters","To assess the tolerability of YN003 in subjects with recurrent/progressive glioma (WHO grade 3 - 4)"],"hasResults":false,"conditionSlugs":["glioblastoma"],"drugSlugs":[],"locationSlugs":["los-angeles-california","san-francisco-california","houston-texas","beijing-china"],"enrichment":{"headline":"Phase 1: testing YN003 Injection for Glioma","inPlainEnglish":"This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary how well it works of YN003 Injection in patients with recurrent or progressive glioma. The study consists of Part A (dose escalation using a Bayesian Optimal Interval design) and Part B (dose expansion at the recommended Phase 2 dose).","whoItsFor":["Ages 18 Years to 70 Years","Male or female subjects 18 years ≤ aged ≤ 70 years","Histologically confirmed recurrent or progressive glioma, including glioblastoma, as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, Grade 3 to Grade 4, following standard therapy.Excluding re-irradiation for same lesions","Karnofsky Performance Status (KPS) ≥60","At least one measurable lesion per RANO 2.0 criteria","Have adequate hematologic, cardiac, hepatic, renal, coagulation, and pulmonary function at final screening","Have completed the required washout period for prior therapies before dosing on Day 1","Corticosteroid dose must be stable or tapering within 7 days prior to dosing"],"whoShouldSkip":["Participation in another treatment clinical study within 1 month prior to the date when subject signed the consent form","Receipt of a live vaccine within 30 days prior to study treatment","Pregnant or breastfeeding women","Clinically significant intracranial hypertension (e.g., impending brain herniation or requiring urgent palliative intervention) or uncontrolled seizures. Subjects requiring antiepileptic drugs are eligible only if the dose has been stable for ≥ 14 days prior to first dosing","Toxicities from prior anticancer therapy that have not recovered to CTCAE v6.0 Grade ≤1, except for alopecia or other events considered tolerable by the investigator","Contraindications to MRI, including but not limited to pacemakers, epicardial pacing leads, infusion pumps, aneurysm clips, metal fragments, metallic prostheses, magnetic implants, intraocular metal objects, or non-removable metallic dental implants","Uncontrolled or severe cardiovascular or cerebrovascular disease"],"whatHappens":"If you join, the listed intervention(s) are YN003 Injection. The registry lists allocation as na. This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to measure the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary how well it works of YN003 Injection in patients with recurrent or progressive glioma.","phaseExplainer":"Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.","effort":"They plan to enroll about 50 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:05.469Z"},{"nctId":"NCT07930169","title":"Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.","officialTitle":"A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.","status":"RECRUITING","phases":[],"studyType":"OBSERVATIONAL","allocation":null,"interventionModel":null,"masking":null,"sponsor":"HK inno.N Corporation","sponsorClass":"INDUSTRY","summary":"This study will be conducted under routine clinical practice in adults diagnosed with advanced chronic renal failure for whom treatment with Kremezin immediate-release tablets or Kremezin fine granules has been determined as part of standard clinical care. Kremezin will be prescribed and administered in accordance with the approved product labeling. Study data will be collected at up to three time points through Week 48: baseline, Week 24, and Week 48. Effectiveness will be assessed using serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and the investigator's overall assessment; treatment satisfaction and safety information will also be collected.","conditions":["Chronic Kidney Disease"],"keywords":[],"interventions":[],"enrollment":3125,"startDate":"2023-07-18","completionDate":"2027-12-31","sex":"ALL","minAge":"19 Years","maxAge":null,"healthyVolunteers":false,"eligibilityRaw":"Inclusion Criteria:\n\n* Adults aged 19 years or older diagnosed with advanced chronic renal failure.\n* Individuals who voluntarily decide to participate and provide written informed consent.\n\nExclusion Criteria:\n\n* Individuals for whom Kremezin immediate-release tablets or Kremezin fine granules are contraindicated according to the product labeling.\n* Individuals with AST or ALT levels at least three times the upper limit of normal.\n* Individuals with chronic alcoholism.\n* Individuals with an active or progressive infection.\n* Pregnant or breastfeeding individuals.\n* Individuals with a history of dialysis.","locations":[{"facility":"HK inno.N","city":"Seoul","state":"","country":"South Korea","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Yongan Jeong","phone":"+82-31-5176-4673","email":"yongan.jeong@inno-n.com"},{"name":"Nayoung Lee","phone":"+82-31-5176-4675","email":"nayoung.lee1@inno-n.com"}],"primaryOutcomes":["Proportion of participants with an effective overall assessment at Week 24"],"hasResults":false,"conditionSlugs":["als","chronic-kidney-disease"],"drugSlugs":[],"locationSlugs":["seoul-south-korea"],"enrichment":{"headline":"Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Ki…","inPlainEnglish":"This study will be conducted under routine clinical practice in adults diagnosed with advanced chronic renal failure for whom treatment with Kremezin immediate-release tablets or Kremezin fine granules has been determined as part of standard clinical care. Kremezin will be prescribed and administered in accordance with the approved product labeling.","whoItsFor":["Ages 19 Years to any","Adults aged 19 years or older diagnosed with advanced chronic renal failure"],"whoShouldSkip":["Individuals for whom Kremezin immediate-release tablets or Kremezin fine granules are contraindicated according to the product labeling","Individuals with AST or ALT levels at least three times the upper limit of normal","Individuals with chronic alcoholism","Individuals with an active or progressive infection","Pregnant or breastfeeding individuals","Individuals with a history of dialysis"],"whatHappens":"This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.","phaseExplainer":"This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.","effort":"They plan to enroll about 3,125 people at Seoul. Taking part typically means study visits and measurements plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:12.488Z"},{"nctId":"NCT07930182","title":"Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring","officialTitle":"Adjuvant/Neoadjuvant Immunotherapy in Melanoma Based on Serial Plasma ctDNA Monitoring","status":"RECRUITING","phases":["PHASE2"],"studyType":"INTERVENTIONAL","allocation":"NON_RANDOMIZED","interventionModel":"PARALLEL","masking":"NONE","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","sponsorClass":"OTHER","summary":"The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.","conditions":["Melanoma"],"keywords":[],"interventions":[{"type":"DRUG","name":"Nivolumab"},{"type":"DRUG","name":"Ipilimumab"},{"type":"DIAGNOSTIC_TEST","name":"Haystack MRD ctDNA Assay"}],"enrollment":56,"startDate":"2026-10-21","completionDate":"2030-10-21","sex":"ALL","minAge":"18 Years","maxAge":null,"healthyVolunteers":true,"eligibilityRaw":"Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed melanoma (excluding uveal melanoma)\n* Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma\n* Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma\n* ECOG Performance Status ≤2\n* Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN.\n* Baseline imaging obtained within 28 days prior to treatment initiation\n* Negative pregnancy test for women of childbearing potential\n* Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n* Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment\n* Contraindication to nivolumab and/or ipilimumab\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments\n* Unresectable disease\n* Uveal melanoma\n* Any medical, psychiatric, or social condition that would interfere with protocol compliance or study participation","locations":[{"facility":"Moffitt Cancer Center","city":"Tampa","state":"Florida","country":"United States","status":"RECRUITING","lat":null,"lon":null}],"contacts":[{"name":"Anjana Menon","phone":"813-745-5537","email":"Anjana.Menon@moffitt.org"}],"primaryOutcomes":["Event-Free Survival (EFS) in the Neoadjuvant Cohort","Relapse-Free Survival (RFS) in the Adjuvant Cohort"],"hasResults":false,"conditionSlugs":["melanoma"],"drugSlugs":["nivolumab"],"locationSlugs":["tampa-florida"],"enrichment":{"headline":"Phase 2: testing Nivolumab for Melanoma","inPlainEnglish":"The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.","whoItsFor":["Ages 18 Years to any","Histologically confirmed melanoma (excluding uveal melanoma)","Neoadjuvant Cohort: Surgically resectable AJCC 8th edition Stage III or Stage IV melanoma","Adjuvant Cohort: Completely resected AJCC 8th edition Stage IIB, IIC, III, or IV melanoma","how well you can do daily activities (ECOG score) ≤2","Adequate organ function: AST and ALT ≤5 × upper limit of normal (ULN) and Creatinine ≤2 × ULN","Baseline imaging obtained within 28 days prior to treatment initiation","Negative pregnancy test for women of childbearing potential"],"whoShouldSkip":["Prior anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 therapy within 1 year before enrollment","Contraindication to nivolumab and/or ipilimumab","Active autoimmune disease requiring systemic immunosuppressive therapy","Concurrent malignancy requiring active treatment that could interfere with study treatment or assessments","Unresectable disease"],"whatHappens":"If you join, the listed intervention(s) are Nivolumab, Ipilimumab, or Haystack MRD ctDNA Assay. The registry lists allocation as randomized. The purpose of the study is to see if periodic (serial) blood-based testing of ctDNA (circulating tumor DNA) while receiving study treatment with study drug therapy for advanced melanoma (skin cancer) can be used to decide the best plan for care during and after initial study drug treatment.","phaseExplainer":"Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.","effort":"They plan to enroll about 56 people at Tampa. Taking part typically means taking a study drug (or dummy pill) plus check-ins.","source":"rules","llamaTemperature":null,"grounds":{"headline":"BriefTitle + Phase + InterventionName + Condition (registry fields only)","inPlainEnglish":"BriefSummary, simplified phrasing — no added facts","whoItsFor":"EligibilityCriteria (Inclusion) + MinimumAge + MaximumAge + Sex","whoShouldSkip":"EligibilityCriteria (Exclusion)","whatHappens":"InterventionName + StudyType + DesignAllocation + BriefSummary","phaseExplainer":"Phase + StudyType; FDA phase labels, not a claim this study worked","effort":"EnrollmentCount + LocationCity count + InterventionType"}},"lastEnrichedAt":"2026-11-11T06:15:04.799Z"}]}